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1 2 | user manual 865221 english | Users Manual | 2.43 MiB | December 06 2017 |
Instructions for Use IntelliVue Cableless Measurements CL SpO2 Pod CL NBP Pod CL Respiration Pod Release D.00 Patient Monitoring 1Table of Contents 1 Introduction and Basic Operation Safety Information Security Information Introducing the IntelliVue Cableless Measurements 2 IntelliVue CL SpO2 Pod General Operation of the SpO2 Pod Connection with Host Systems Monitoring SpO2 Alarms Local Attended Monitoring SpO2 Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 3 IntelliVue CL NBP Pod General Operation of the NBP Pod Connection with Host Systems Monitoring NBP Alarms Local Attended Monitoring NBP Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 4 IntelliVue CL Respiration Pod General Operation of the Respiration Pod Connection with Host Systems Monitoring Respiration Technical Alarms (INOPs) Respiration Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 5 Cableless Measurement Auxiliary Devices IntelliVue CL Transmitter and IntelliVue CL Hotspot IntelliVue CL Transmitter Base Station 5 6 8 10 13 13 20 28 34 43 49 50 52 53 55 55 62 69 77 86 91 92 93 97 99 99 100 104 108 109 110 111 112 113 113 117 3 IntelliVue CL Charging Station Maintenance and Troubleshooting 6 Care and Cleaning General Points Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices Disposing of the IntelliVue Cableless Measurement Devices 7 Specifications Indications for Use Compatible Medical Devices Symbols Manufacturer's Information Regulatory and Safety Specifications EMC and Radio Regulatory Compliance Safety and Performance Tests Electromagnetic Compatibility (EMC) Accessories Compliant with EMC Standards Electrosurgery Interference/Defibrillation IntelliVue CL SpO2 Pod Specifications IntelliVue CL NBP Pod Specifications IntelliVue CL Respiration Pod Specifications Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod Telemetry Device Battery Runtime Specifications IntelliVue CL Transmitter Specifications IntelliVue CL Transmitter Base Station Specifications IntelliVue CL Hotspot Specifications Index 118 119 121 121 122 123 125 125 127 127 129 129 130 132 132 133 133 133 135 138 140 141 141 143 144 147 4 1Introduction and Basic Operation 1 These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their specified compatible accessories. IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO2 Pod (865215), IntelliVue CL NBP Pod (865216) and IntelliVue CL Respiration Pod (865218) with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station (865220), IntelliVue CL Transmitter (865221), IntelliVue CL Transmitter Base Station
(865237) and IntelliVue CL Hotspot (865222). The IntelliVue Cableless Measurements are used for monitoring and recording arterial oxygen saturation, pulse rate, noninvasive blood pressure and respiration rate of adult and pediatric patients. Familiarize yourself with all instructions including warnings and cautions, and attend one of the training courses, before starting to make measurements with patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here. When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor, an Avalon Fetal Monitor, a telemetry system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use of the respective device or software. This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details. In these Instructions for Use:
A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Display refers to the physical display of the Cableless Measurement Device. Screen refers to everything you see on the IntelliVue Cableless Measurement's display, such as measurement values, patient data and so forth. IntelliVue CL Transmitter/WLAN functionality may not be available in all countries. 5 1 Introduction and Basic Operation Safety Information Use Environment WARNING Electrical Hazards If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. Keep the patient monitor with the patient during transport. Always make sure that the applied pod is assigned to the correct patient. WARNING Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel. Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the charging station to fit an ungrounded AC mains socket. Do not use AC mains extension cords or multiple portable socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in enclosure leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of a system. Radiofrequency Interference WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the NBP or SpO2 Pods, or a cl NBP Disconnect, cl SpO Disconnect or cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Battery Handling WARNING Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. Do not incinerate the devices or expose them to temperatures above 60C (140F). 6 Accessories 1 Introduction and Basic Operation WARNING Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. Philips approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices. Maintenance WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Care, Cleaning and Disposal WARNING If you spill liquid on the equipment, or if the equipment is accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. Do not use flammable agents for disinfecting the equipment in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff. To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the IntelliVue Cableless Measurement Devices appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste. 7 1 Introduction and Basic Operation Security Information Protecting Personal Information Protecting personal health information is a primary component of a security strategy. Each facility using the devices must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facilitys policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats. As per their intended use, the devices operate in the patient vicinity and contain personal and sensitive patient data. They also include controls to allow you to adapt the devices to the patient's care model. To ensure the patient's safety and protect their personal health information you need a security concept that includes:
Physical security access measures - access to the devices must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access. Operational security measures - for example, ensuring that devices are powered off after monitoring in order to remove patient data from the device. Procedural security measures - for example, assigning only staff with a specific role the right to use the devices. In addition, any security concept must consider the requirements of local country laws and regulations. Always consider data security aspects of the network topology and configuration when connecting devices to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred. When a device is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the device by powering it off. NOTE Log files generated by the devices are used for system troubleshooting and do not contain protected health data. About HIPAA Rules If applicable, your facilitys security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit:
http://www.hhs.gov/ocr/privacy/
About the EU Directives If applicable, your facilitys security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional applicable regulation or statutory requirement. Philips Product Security Policy Statement Additional security and privacy information can be found on the Philips product security web site at:
http://www.usa.philips.com/healthcare/about/customer-support/product-security 8 1 Introduction and Basic Operation Manufacturer Disclosure Statement for Medical Device Security MDS2 You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at:
http://www.usa.philips.com/healthcare/about/customer-support/product-security 9 1 Introduction and Basic Operation Introducing the IntelliVue Cableless Measurements The IntelliVue Cableless Measurement Devices provide measurement values and communicate them to other system components using a wireless short range radio (SRR) interface. Introduction IntelliVue CL SpO2 Pod The IntelliVue CL SpO2 Pod is a battery powered, cableless Pulse Oximetry measuring device. IntelliVue CL NBP Pod The IntelliVue CL NBP Pod is a battery powered, cableless, noninvasive blood pressure (NBP) measuring device. IntelliVue CL Respiration Pod The IntelliVue CL Respiration Pod is a battery powered, cableless device for measuring respiration rate and, optionally, pulse. It also provides basic information about patient posture and activity. 10 1 Introduction and Basic Operation Basic Operation IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod The IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers TRx4841A/
TRx4851A, MX40 wearable patient monitors, Avalon Fetal Monitors, and IntelliVue GuardianSoftware. Both devices have an LC display and three keys for basic operation:
Integrated monochrome LC display 1 2 Hardkeys 3 Measurement identifier IntelliVue CL Respiration Pod The IntelliVue CL Respiration Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/
MP5T, MP2/X2, or IntelliVue GuardianSoftware. The device has one multi-color LED for status display and one hardkey for basic operation, e.g. to start a measurement. 1 Multi-color LED 2 Measurement identifier 3 Hardkey 4 Indication for built-in RFID tag 11 1 Introduction and Basic Operation 12 2 2IntelliVue CL SpO2 Pod The IntelliVue CL SpO2 Pod is a wrist-worn device; you need a Mobile CL SpO2 Cradle to hold the sensor connector in place and a wristband to fix the cradle to a patient's arm. Specialized single-patient SpO2 sensors are available for use with the IntelliVue CL SpO2 Pod. For details regarding the complete set of single-patient supplies, cradle, wristband and sensors, refer to IntelliVue CL SpO2 Pod Accessories on page 52. General Operation of the SpO2 Pod The following sections describe operation on the SpO2 Pod itself. For operation from a patient monitor, see Controls Available with a Patient Monitor on page 25. For operation from an Information Center via a telemetry system, see Controls Available with a Telemetry Device on page 26. For operation with IntelliVue GuardianSoftware, see Controls Available with GuardianSoftware on page 27. The SpO2 Pod has three hardkeys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily. Switching the Device On The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on. If the SpO2 Pod has only been switched off temporarily (see Switching the Device Off on page 17), press any hardkey to turn the device on again. When an SpO2 Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed. 13 2 IntelliVue CL SpO2 Pod Screen Layout There are three variations of the Main Screen layout depending on the Alarm status and the general activity level. Standard Layout When assigned to a monitor, telemetry device or a patient in GuardianSoftware:
1 2 Connection status indicator Indicator that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. Battery indicator 3 4 Measurement values 5 Measurement-related symbols (see the Monitoring SpO2 section for details) Patient identification 6 When not assigned to a monitor or telemetry device:
Connection status indicator Battery indicator 1 2 3 Measurement values 4 Measurement-related symbols (see the Monitoring SpO2 section for details). The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. 5 Cableless Measurement Device equipment label Alarm Layout If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has been silenced the alarm indicator is shown as a symbol on the right side of the screen. Full length alarm message 1 2 Alarm indicator 14 Low-Activity Screen If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen. 2 IntelliVue CL SpO2 Pod When a Cableless Measurement Device Cannot be Activated If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged. Using the Hardkeys The IntelliVue Cableless Measurement Devices have three hardkeys: , , . Use and to navigate through SmartKeys and menus and to select items or to silence alarms. The three hardkeys also have an additional function when the key is held down for a couple of seconds:
opens the Add To screen to assign a device (or to unassign it when it is already assigned) opens the SmartKeys menu returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears Using the SmartKeys A SmartKey is a graphical key which appears on the screen and gives you fast access to functions. SmartKeys Menu Press the hardkey (without any screen element highlighted) to get to the SmartKeys menu. Use the and hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the or hardkey at the end of the row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the Exit screen or press the hardkey for a couple of seconds to return to the Main Screen. When the required SmartKey is highlighted, press the key to activate the corresponding function. To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the key. 15 2 IntelliVue CL SpO2 Pod List of Available SmartKeys SmartKey Text Labels Main Setup start an SpO2 measurement set the SpO2 mode Add/Remove device enter Battery menu enter Profiles menu change Screen put device in standby mode (or power off when pressed for more than two seconds) enter Patient menu enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/
Off/Pause, Alarm Volume. Change alarm volume Change pulse tone volume 16 Using the Main Setup Menu In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get to the Main Setup menu. 2 IntelliVue CL SpO2 Pod Main Setup SpO Pulse Alarms Patient Equipment User Interface Standby Profiles Operating Modes Date, Time Battery Revisions Switching the Device Off To put the device in standby mode, select the Standby SmartKey, then Confirm. If you keep Standby pressed for more than two seconds, you can choose between Standby or Power Off. Standby means that the display is switched off and the measurements are disabled. Use this option if your device is not used temporarily. Press any hardkey to turn the device on again. Power Off means that the device is switched off completely and can only be switched on again by putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping. Auto Standby and Auto Power Off The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings. Operating Modes Your device has four operating modes. Some are passcode protected. Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode. Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring. Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on. 17 2 IntelliVue CL SpO2 Pod Service Mode: Passcode protected, this is for trained service personnel. When you switch the device on, it starts up in monitoring mode. To change to a different mode:
1 Use the Main Setup SmartKey to get to the Main Setup menu. 2 Select Operating Modes and choose the mode you require. Using the Patient Menu The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data which can be changed at the Cableless Measurement Device, but only when the device is not assigned to a patient monitor or telemetry device. Displaying the Patient Menu To display the Patient menu, select the Patient SmartKey, or select the Main Setup SmartKey followed by Patient. Stop Using a Device for a Patient in the Patient menu select Free Device. To remove a patient from the Cableless Measurement Device, All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor or telemetry device. NOTE Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient. Using the Device for a New Patient To use a device for a new patient, If the device was not free, the existing data will be deleted and the profile set to the default. in the Patient menu, select New Patient. Using Profiles A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol. To select a different profile, 1 2 Selecting New Patient or Free Device will always reset the profile to the default. Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles. Select the required profile from the list. 18 Setting the Date and Time 2 IntelliVue CL SpO2 Pod Select the Main Setup SmartKey and then Date, Time. If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the date and time on the Cableless Measurement Device, 1 2 Enter the data for date and time one after another. 3 If the time has not been set, --:-- will display on the device. Select Store Date, Time. Battery Status The IntelliVue CL SpO2 Pods show their battery status on their display both in operating and charging condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging. Battery Status Menu Select the Battery SmartKey or Main Setup followed by Battery using the and keys, then press the key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature. 19 2 IntelliVue CL SpO2 Pod Connection with Host Systems The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware). IntelliVue Cableless Measurements Use Models With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models:
With a Patient Monitor The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table Controls Available with a Patient Monitor on page 25. In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring. When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See Alarms on page 34 for details. A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor. When assigned to a patient monitor, the admitted patient name is displayed on the SpO2 Pod. If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl SpO Disconnect. A No Host Monitoring INOP will be displayed on the SpO2 Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the SpO2 Pod, but it is not possible to change the alarm settings. With a Fetal Monitor In combination with an Avalon CL Transducer System, the IntelliVue CL SpO2 Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The SpO2 Pods are assigned to the fetal monitor by docking them at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use. With a Telemetry Device The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/
TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values. Some of the measurement tasks can be performed remotely from the Information Center. See the table Controls Available with a Telemetry Device on page 26. If the patient name is available at the Information Center, it will be also displayed on the SpO2 Pod. 20 2 IntelliVue CL SpO2 Pod When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor. If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: cl SpO Disconnect. A No System Monitor. INOP will be displayed on the SpO2 Pod, and an INOP tone will sound. With IntelliVue GuardianSoftware The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices. Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table Controls Available with GuardianSoftware on page 27. GuardianSoftware also manages the patient data. If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed on the SpO2 Pod
(no alarm sound). If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of patient data will be synchronized between the Pods and GuardianSoftware. The only patient management action available directly at the Pod is Free Device. Selecting Free Device removes the current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned. Device Compatibility IntelliVue Patient Monitor - Release H.0 or above Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above IntelliVue Information Center - Release M or above Philips Patient Information Center iX - Release A or above Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above The IntelliVue CL SpO2 Pods require the following software levels in the associated equipment:
MX40 wearable patient monitor - Revision A.0 or above IntelliVue GuardianSoftware - Revision A.0 or above Availability of Patient Alarms When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry device, no patient alarms will be generated. When the IntelliVue CL SpO2 Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center. When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details. If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text 21 2 IntelliVue CL SpO2 Pod appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See Alarms on page 34 for details. When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details. When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware. Assigning an IntelliVue Cableless Measurement Device to a Host When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Pod must be assigned to that host system. The assignment can be done at the CL SpO2 Pod itself or at the host system (patient monitor or GuardianSoftware). WARNING Always make sure that the applied CL SpO2 Pod is assigned to the correct patient. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Assignment at the Measurement Device To make an assignment, select:
, or the Add/Remove SmartKey hold the key pressed. This opens the Add To menu which lists the available patient monitors and telemetry devices within the SRR range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds. Telemetry device: A telemetry device must be put into assignment mode by pressing the key on the telemetry device before it can appear in the list. Pressing the key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will 22 take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment. 2 IntelliVue CL SpO2 Pod Add To Mon 1 Mon 2 Tele 33 Tele 44 1 Select a patient monitor or telemetry system using the and keys. If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device. 2 Activate the assignment by pressing the key twice on the measurement device. The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message. If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this:
1 Select the measurement selection key on the monitor. A prompt message appears with the Confirm and Cancel keys. Select Confirm to deactivate the internal measurement. 2 When the Cableless Measurement Device is assigned, the alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. To unassign the measurement device from the monitor or telemetry system, select the Add/Remove SmartKey, then select Remove From. After confirmation the SRR connection is disconnected. symbol appears on its display indicating that Assignment at the Patient Monitor Assignment at the Patient Monitor Prepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey. At the patient monitor, 1 2 Select the Measurement Selection key. Select the Add cl Msmt pop-up key. This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices:
Select the device which you want to assign to the patient in the monitor. The monitor displays the assignment prompt message. 3 4 If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. When the Cableless Measurement Device is assigned, the alarms from the device will be sent to the patient monitor. symbol appears on its display indicating that 23 2 IntelliVue CL SpO2 Pod An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor. Assignment with an RFID Reader and Tagged Cableless Devices You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The SpO2 Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached. 1 Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. 2 The Cableless Measurement Device is now added to the monitor. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting Replace. If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Assignment at the Fetal Monitor The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station. NOTE When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient. Special Conditions when Working with Fetal Monitors The following special conditions apply when CL SpO2 Pods are operating with an Avalon Fetal Monitor as a host:
The SpO2 Pods are intended to measure the maternal SpO2 and Pulse. The patient category is always Adult. The Pulse measurement is always On. The Pulse: On/Off setting is not available. Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available: Use for Transp. is not supported. (Local attended monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver). Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information. 24 2 IntelliVue CL SpO2 Pod You can use the Remove operation at the host to remove Cableless Measurement Devices, as described in the Avalon Fetal Monitor Instructions for Use. Averaging Time is not configurable. Smart Alarm Delay is not supported. Pulse tone from the CL SpO2 Pod is not supported at the Avalon Fetal Monitor. Perfusion is always Off and cannot be changed to On. Perfusion Change Indicator is not supported. It is not possible to change the label, it is always SpO. Continuous mode only. The functions for starting a measurement, selecting the measurement mode and setting the repetition time are not supported. Configuration of Aging Time (for Aging Numerics) is not possible. Pleth wave is not available. Assignment with GuardianSoftware To assign a Cableless Measurement Device to a patient in GuardianSoftware:
1 2 3 On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, Select the patient on the Chalkboard. Take the Cableless Measurement Device from the charger. highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed). 4 Click Use for Patient to assign the device to the patient. Controls Available with a Patient Monitor The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below. Action At the IIC At the Patient Monitor At the Cableless Measurement Device Yes Yes Yes Yes Yes Yes*
Yes Yes Yes Start SpO2 Change SpO2 Mode Select SpO2 Repetition Time Assign SpO2 Pod Remove SpO2 Pod Change Alarm Limits Place Device in Standby Alarm Silence Alarm Off/Pause
* except when SRR connection to host is lost Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No Yes Yes Yes 25 2 IntelliVue CL SpO2 Pod WARNING If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone. Controls Available with a Telemetry Device The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below. Action At the IIC Start SpO2 Change SpO2 Mode Select SpO2 Repetition Time Assign SpO2 Pod Remove SpO2 Pod Change Alarm Limits Place Device in Standby Alarm Silence Alarm Off/Pause At the Cableless Measurement Device Yes Yes Yes Yes Yes No No No No Yes Yes No No Yes Yes No Yes Yes NOTE When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The SpO2 measurement devices assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements. NOTE The SpO2 measurement sourced from the telemetry device (label: SpO2T) has priority over the IntelliVue CL SpO2 measurement. The SpO2T measurement is sent to the Information Center as long as it is available and the IntelliVue CL SpO2 measurement is available on the measurement device only. 26 Controls Available with GuardianSoftware 2 IntelliVue CL SpO2 Pod The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below. Action At GuardianSoftware Start SpO2 Change Mode Select SpO2 Repetition Time Assign SpO2 Pod Remove SpO2 Pod Place Device in Standby Technical Alarm Silence Alarm Off/Pause Trending At the Cableless Measurement Device Yes Yes Yes Yes Yes No No No Yes Yes Yes Yes Yes No Yes No The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system. When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage. 27 2 IntelliVue CL SpO2 Pod Monitoring SpO2 Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact suppression technology (FAST). A sensor is used that transmits light of two different wavelengths through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides four measurements:
Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). Pleth waveform - auto-scaled visual indication of patient's pulse which is not directly proportional to the pulse volume (only on patient monitor, GuardianSoftware or Information Center, if assigned). Pulse rate (derived from pleth wave) - detected pulsations per minute. Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by arterial pulsation (only on patient monitor, if assigned). NOTE No alarms are generated for SpO2 and Pulse when measuring SpO2 with the SpO2 Pod not assigned to a patient monitor or telemetry device. The SpO2 measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30. SpO2 Sensors Specialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See the IntelliVue CL SpO2 Pod Accessories section for details. Familiarize yourself with the Instructions for Use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. Additional Information The following documents contain additional information, depending on which accessories you are using:
Mobile CL Single-Patient SpO2 Sensor Instructions for Use Mobile CL Reusable SpO2 Sensor1 Instructions for Use Mobile CL SpO2 Wristband Instructions for Use 1 may not be available in all geographies 28 Connecting SpO2 Sensors 1 Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected). 2 IntelliVue CL SpO2 Pod 2 Insert the SpO2 Pod into the Mobile CL SpO2 Cradle. The correct orientation is indicated by a matching blue dot inside the cradle. CAUTION Make sure that the contacts of the SpO2 Pod and the sensor are dry and free of residues. 3 Secure the cradle on the patient's arm using the wristband. a. Feed the free end of the wristband through the slot in the cradle, starting from the underside of the cradle. Slide the wristband onto the patient's arm and pull the free end until the wristband fits snugly. b. c. Close the wristband using the Velcro patch on the free end of the band. 29 2 IntelliVue CL SpO2 Pod Removing the Pod from the Cradle To remove the SpO2 Pod from the cradle, pull on the Pod at the opening in the cradle, while holding the cradle in place on the patient's arm. Applying the Sensor 1 Choose a finger of the patient that matches the sensor dimension in a way that the sensor optical components are properly aligned and the sensor is neither too loose nor applies too much pressure to the finger. For small pediatric patients consider the thumb. 2 Remove colored nail polish from the application site. 3 Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. See the sections below for details on applying the different sensors. 4 Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue. WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41C on the skin if the initial skin temperature does not exceed 35C. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line. 30 2 IntelliVue CL SpO2 Pod Measuring SpO2 During measurement, ensure that the application site:
has a pulsatile flow, ideally with a perfusion indicator value above 1.0 or, if the perfusion indicator is not available, with signal quality indicator of at least medium. has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor. WARNING If not specified otherwise in the SpO2 sensor's instructions for use, the following applies:
For fully conscious pediatric or adult patients, who have a normal function of perfusion and sensory perception at the measurement site:
To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients:
Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream. Interference can be caused by:
High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-
interference. Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium. Excessive patient movement and vibration. Selecting Measurement Modes There are three different modes available for making SpO2 measurements:
Manual mode - a single SpO2 measurement is made when the Start SpO SmartKey or the Start SpO Continuous mode - SpO2 is measured continuously until the measurement is switched off. menu item is selected. One set of values is then displayed with the time the measurement was made. Automatic mode - a series of measurements is made with an interval between them. The interval is selected using the Repeat Time SmartKey or the Repeat menu item. The measurement starts automatically when automatic mode is selected. The values measured in manual mode or automatic mode will be displayed for a configurable time span. After that the values are regarded as invalid and are no longer displayed. Battery power usage will be appreciably higher when measuring in continuous mode, in comparison to manual or automatic mode, resulting in a reduced battery runtime. 31 2 IntelliVue CL SpO2 Pod Starting and Stopping Measurements Use the setup menu or SmartKeys to start measurements manually:
Action to be Performed Start manual measurement SpO2 menu Start SpO SmartKeys Start When manual measurements are made, there will be no continuous SpO2 monitoring or alarming. The manual measurement value reflects a momentary status. The numerics from SpO2 measurements made in manual mode will remain for a time on the main screen. They are annotated with the time that the measurement was made to distinguish them from continuously measured values. Understanding SpO2 Numerics and Symbols SpO2 numeric Pulse rate numeric Symbol indicating pulse rate 1 2 3 4 Measurement mode - indicates here that Auto mode is active and shows the time to the next measurement. 5 Alarms Off symbol for Pulse 6 7 Alarms Off symbol for SpO2 Timestamp Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. SpO2 Signal Quality Indicator The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality, the signal quality is at a maximum when the triangle is completely filled. 1 SpO2 Quality Indicator 32 2 IntelliVue CL SpO2 Pod Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse. When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value. If you doubt the measured SpO2, use the signal quality indicator (if available) or, when used with a patient monitor, the pleth wave and perfusion indicator on the monitor to assess the signal quality. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. Changing the Averaging Time Depending on the monitor configuration, you may be able to change the averaging time for the SpO2 values. The averaging time represents the approximate time period used for the calculation. The exact averaging time also depends on the signal conditions. The longer the averaging time, the longer the time needed until the SpO2 values reflect the physiological event. The same averaging is applied to all numerical values: SpO2, pulse rate and perfusion (only available at the patient monitor). Fast averaging is useful for situations where an extremely fast measurement is required or few artifacts are expected. Use slow averaging where you expect the number of artifacts to be relatively high. 1 2 In the SpO menu, select Average. Select the required averaging time from the list. Perfusion Numeric (only available on the Patient Monitor) The perfusion numeric (Perf) gives a value for the pulsatile portion of the measured signal caused by the pulsating arterial blood flow. You can also use the perfusion numeric as a quality indicator for the SpO2 measurement. Above 1 is optimal, between 0.3-1 is acceptable. Below 0.3 is marginal; reposition the sensor or find a better site. 33 2 IntelliVue CL SpO2 Pod Alarms The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs). Patient Alarms Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red alarms, or medium priority alarms, also called yellow alarms. Technical Alarms (INOPs) Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection. Most INOPs are low priority, however there are a small number of INOPs which, due to their severity, are medium or high priority. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components:
The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter IntelliVue CL SpO2 Pod Specifications on page 133 for the system alarm delay specification of the Cableless Measurement Device. The alarm delay configured for a specific measurement is normally a fixed time. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe. NOTE If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02. Visual Alarm Indicators WARNING No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor
(unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. 34 2 IntelliVue CL SpO2 Pod Alarm Message Alarm messages are displayed in black on a light gray background in the alarm status area at the top of the screen indicating the source of the alarm and coded according to their severity. If more than one measurement is in an alarm condition, the message changes every few seconds, and has an arrow (
) at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. An alarm message that appears is automatically highlighted. Use the key to silence the message. A Silence message is displayed at the bottom of the screen and highlighted. Press again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen. Alarm States Depending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device:
Icon Description No local alarming on Cableless Measurement Device. The device is connected to a host monitor or telemetry device and has no visual or audible patient alarm indicators. The device will only display INOP messages. Alarms are switched off. Alarm volume is set to 0. Audible Alarm Indicators Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume. WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware. When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to). 35 2 IntelliVue CL SpO2 Pod Silencing an Alarm To silence an alarm, select the alarm message and press the key. This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed in the icon tray of the screen. Full length alarm message 1 2 Alarm indicator When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device. Otherwise you will get a technical alarm (cl SpO Disconnect) that can not be silenced at the telemetry device. You will then have to reboot the telemetry device to remove the message. Displaying a List of Current Alarms To display a list of the currently active alarms, 1 2 Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select Alarm Messages. Setting the Volume of the Alarm Tone To set the volume for the Alarm tone, 1 2 Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on your configuration. If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray of the Cableless Measurement Device screen:
NOTE No Alarm tone will sound at the device as long as it is within the SRR range. Minimum Volume for No Host Monitoring INOP If your device is connected to a host monitor, and the connection is interrupted, the INOP message No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the device alarm volume is set to zero. 36 2 IntelliVue CL SpO2 Pod Alarm Reminder If Reminder is configured on your device, you will get an audible reminder of alarm conditions that remain active after you have silenced the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off. To view the alarm pause setting chosen for your unit, 1 2 Check the setting. This setting can only be changed in Configuration Mode. In the SmartKeys Menu select Main Setup, Alarms, then OffDurat. To Pause or Switch Off Alarms Select the Paused. If your device is configured to infinite pause time, selecting this option switches alarms off. key in the SmartKeys Menu followed by Alarms. Press the hardkey to switch to Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the key Alarm indication starts again automatically after the pause period expires. If the device is configured to stay again. paused infinitely, you must select again to restart alarm indication. 37 2 IntelliVue CL SpO2 Pod Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For SpO2, where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In these cases, the alarms off symbol is not displayed. WARNING Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Adjusting the Alarm Limits 1 2 3 Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by SpO):
Select High Lim then choose the high alarm limit. Select Low Lim then choose the low alarm limit. WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high alarm off. Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. 1 2 Adjust the limit. In the SpO menu, select DesatLim. Setting Up Tone Modulation Only when the Cableless Measurement Device is not connected to a host:
If tone modulation is on, the pulse tone pitch lowers when the SpO2 level drops. Select Main Setup followed by User Interface. In this menu, select Tone Modulation to switch between Yes
(for on) and No (for off). NOTE If the SpO2 level drops below 52%, two short tones will be issued rather than one long tone. Latching Alarms The alarm latching setting for your device defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the device after the alarm condition ends. The indication lasts until you acknowledge the alarm. 38 2 IntelliVue CL SpO2 Pod Viewing the Alarm Latching Settings In the Main Setup menu, select Alarms. To see the alarm latching setting for your device, 1 2 Here you can see the Visual Latching and Audible Latching settings. This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings:
Visual Latching Red&Yellow Red&Yellow Red&Yellow Red Only Red Only Off Audible Latching Red&Yellow Red Only Off Red Only Off Off Alarm Latching Behavior Red & Yellow Measurement Alarms Non-latching alarms Visual and audible latching Visual latching, audible non-latching Alarm has not been acknowledged. Alarm condition still present. Alarm condition no longer present. Alarm tone on. Alarm message. Alarm tone on. Alarm All audible and visual alarm indicators automatically stop. message. Alarm tone on. Alarm message. Alarm has been acknowledged. Alarm condition still present. Alarm condition no longer present. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. All INOPs are non-latching. Testing Alarms Alarm tone on. Alarm message. Alarm message. Audible alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. When you switch the CL SpO2 Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. Alarm Behavior at Power On If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See Switching the Device Off on page 17 and Using Profiles on page 18 for details. When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings. After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct profile and patient category. 39 2 IntelliVue CL SpO2 Pod Reference List of Patient Alarms Alarm Message, Indication
*** Brady (Pulse) Source SpO2
*** Desat
** Pulse High
** Pulse Low
** <SpO Label> High
** <SpO Label> Low
*** Tachy (Pulse) SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 Reference List of all INOPs Source Battery Battery Battery Battery Battery Battery Battery INOP Message, Indication Batt Incompatible INOP tone Batt Malfunction INOP tone Battery Empty INOP tone Battery Low INOP tone Check Batt Temp INOP tone Check Battery INOP tone Check Charger I/F INOP tone 40 Condition The heart rate from the Pulse signal has fallen below the bradycardia limit. The SpO2 value has fallen below the desaturation alarm limit. The pulse rate has exceeded the high alarm limit. The pulse rate has dropped below the low alarm limit. The arterial oxygen saturation has exceeded the high alarm limit. The arterial oxygen saturation has dropped below the low alarm limit. The Pulse Rate from the Pleth signal has exceeded the tachycardia limit What to do Battery cannot be used with this Cableless Measurement Device. Replace battery with one that has been approved for use with this Cableless Measurement Device. Contact your service personnel. Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel. The remaining monitoring time is below 30 minutes. Charge battery. The remaining monitoring time is below 2 hours. The temperature of the battery is critically high. Check that Cableless Measurement Device is not covered and not exposed to a heat source. If INOP persists, remove Cableless Measurement Device from patient and contact your service personnel. The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel to replace the battery. Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. INOP Message, Indication cl SpO Chk Sett INOP tone Source Cableless Measurement Device cl SpO Disconnect only at the host No Host Monitoring INOP tone No System Cableless Measurement Device Cableless Measurement Device Cableless Measurement Device Remove From Pat INOP tone Cableless Measurement Device Service Battery INOP tone
<SpO Label> Equip Malf Numeric is replaced by -?-
INOP tone
<SpO Label> Erratic Numeric is replaced by -?-
INOP tone
<SpO Label> Extd.Update Numeric is replaced by -?-
<SpO Label>Interference Numeric is replaced by -?-
INOP tone
<SpO Label> Low Perf Numeric is replaced by -?-
<SpO Label> NeoPatient?
Numeric is replaced by -?-
INOP tone Battery SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 2 IntelliVue CL SpO2 Pod What to do If this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. The SpO2 Pod has lost the SRR connection to the telemetry device or the patient monitor. There is a problem with the communication to the assigned patient monitor or telemetry device and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. There is a problem with the communication to the assigned IntelliVue GuardianSoftware and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. Displayed on the Cableless Measurement Device. The temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery. The SpO2 Pod is faulty. Contact your service personnel. Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The update time for displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. There is too much interference, caused by a high level of ambient light and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, make sure that the sensor cable is not damaged or positioned too close to power cables. Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site. The patient monitor the SpO2 Pod is assigned to is in neonatal mode. The INOP will remain active until the monitor is changed to adult or pediatric mode. 41 2 IntelliVue CL SpO2 Pod INOP Message, Indication
<SpO Label> No Pulse Numeric is replaced by -?-
INOP tone Source SpO2
<SpO Label> No Sensor Numeric is replaced by -?-
INOP tone
<SpO Label> NoisySignal Numeric is replaced by -?-
INOP tone
<SpO Label> Poor Signal
<SpO Label> Pulse?
Numeric is replaced by -?-
INOP tone
<SpO Label> Searching Numeric is unavailable
<SpO Label> Sensor Malf Numeric is replaced by -?-
INOP tone
<SpO Label> Sensor Off Numeric is replaced by -?-
INOP tone
<SpO Label> Unkn.Sensor Numeric is replaced by -?-
INOP tone
<SpO Label> Upgrade Numeric is replaced by -?-
SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 SpO2 What to do Check the perfusion at the measurement site. If necessary, stimulate circulation or change the measurement site. If the INOP is due to an NBP measurement on the same limb, wait until the NBP measurement is finished. Make sure the SpO2 sensor is connected. If the INOP persists, try another sensor. If you acknowledge this INOP, the measurement will be switched off. Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor. The signal quality of the SpO2 measurement is poor. The accuracy may be compromised. The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. The patient signal is analyzed, but no valid numerics are available yet. The SpO2 sensor is faulty. Try another sensor. If the INOP persists, contact your service personnel. The algorithm has determined that a sensor is connected, but not properly applied to the patient. The ability of the algorithm to detect this condition depends on the used sensor type. The connected SpO2 sensor is not supported by this measurement hardware. SpO2 in upgrade mode, no patient monitoring possible. 42 2 IntelliVue CL SpO2 Pod Local Attended Monitoring When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO2 and NBP Pods can be used for local attended monitoring. This is for situations where you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor
(disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (cl Alarms On/
Off) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on. Local Attended Monitoring Enabled By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A cl SpO Disconnect INOP is shown at the monitor if the SRR connection is lost and the transport mode has not been activated. CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model):
SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
Indication of physiological and technical alarms from CL Pods CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:
No SRR connection At the CL Pod:
Indication of technical and physiological alarms At the monitor:
No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection. 43 2 IntelliVue CL SpO2 Pod Local Attended Monitoring Disabled The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no cl SpO Disconnect INOP is shown at the monitor in this scenario. CL Pod connected to a patient monitor and CL Measurement Alarms Off:
SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods. CL Pod disconnected from patient monitor and CL Measurement Alarms Off:
No SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
No indication of physiological and technical alarms from CL Pods. 44 2 IntelliVue CL SpO2 Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On 1 Standard Use Model 2 Local Attended Monitoring
->
Caregiver activates
'Use for transport'
<-
Caregiver activates
'Use with monitor'
SRR connection no SRR connection Action / Event Situation Standard Use Model:
normal operation, no special action CL Pod connected to the patient monitor (1) Alarm Availability at CL Pod Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Alarm Availability at Patient Monitor Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) 45 2 IntelliVue CL SpO2 Pod Activation of Local Attended Monitoring:
Caregiver activates Local Attended Monitoring and disconnects CL Pod temporarily by setting Use for Transp. in the Patient Monitor's Equipment window Deactivation of Local Attended Monitoring:
Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting Use with Monitor in the patient monitor's Equipment window Patient is in transport without connection to the host system, caregiver attends the patient
(2) Technical alarms
(own) Physiological alarms
(own) Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod Patient returns from transport. Back to the standard use model (1) Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) Special Case:
Connection lost while in Standard Use Model Action / Event Situation Alternative Use Model:
CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiver No Host Monitoring INOP at CL Pod cl SpO Disconnect INOP at patient monitor Local Attended Monitoring is automatically activated (2) Alarm Availability at CL Pod Technical alarms
(own) Physiological alarms
(own) Alarm Availability at Patient Monitor Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod 46 2 IntelliVue CL SpO2 Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off 3 Patient within Range 4 Patient Mobile
->
Patient mobile
<-
Patient back SRR connection no SRR connection Action / Event Situation Connected, but no CL Alarms
(CL Measurement Alarms Off):
normal operation, no special action CL Pod connected to the patient monitor (3) Alarm Availability at CL Pod Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Alarm Availability at Patient Monitor Technical alarms
(own + from Pod) Physiological alarms
(own) 47 2 IntelliVue CL SpO2 Pod Patient is leaving the vicinity of the monitor:
no special action Patient is mobile without connection to the host system
(4) Technical alarms
(own) No physiological alarms Alarms Off icon is displayed in front of each numeric:
Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod Patient returns to the vicinity of the monitor:
no special action Patient returns. Back to connected status (3) Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) 48 2 IntelliVue CL SpO2 Pod SpO2 Default Settings These are the most important default settings of your IntelliVue CL SpO2 Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in Configuration Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will overwrite the settings defined at the Pod. SpO2 Settings Mode Repeat Time Alarms Pulse Volume ToneMod. Perfusion Average NBP Alarm Suppr. Aging Time Color Average in Mon. Signal Quality Label SpO2 Alarm Default Settings Setting DesatLim Low Lim High Lim Desat Delay High Alarm Delay Low Alarm Delay Pulse Settings Pulse Alarms High Lim Low Lim Brady Brady Clamp Factory Defaults Adult Continuous 15 min On 1 Yes On 10 sec On 10 min Cyan (light blue) No On SpO Adult 80 90 100 20 sec 10 sec 10 sec Factory Defaults Adult On On 120 50 20 40 Pedi Continuous 15 min On 1 Yes On 10 sec On 10 min Cyan (light blue) No On SpO Neo Continuous 15 min On 1 Yes On 10 sec On 10 min Cyan (light blue) No On SpO Pedi 80 90 100 20 sec 10 sec 10 sec Pedi On On 160 75 20 40 Neo 80 85 95 20 sec 10 sec 10 sec Neo On On 200 100 20 50 49 2 IntelliVue CL SpO2 Pod Pulse Settings Factory Defaults Adult 20 Tachy 200 Tachy Clamp Integrated Battery Handling Pedi 20 220 Neo 20 240 Only qualified and authorized service personnel (biomedical engineers or technicians) should change batteries. Battery Care Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed. Activity Perform a visual inspection Charge the battery When to perform Before using the IntelliVue Cableless Measurement Device Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. When not in use for an extended period of time, or when the device is shipped. Store the device in a state of charge in the range of 40-50% and power off the device completely. Handling Precautions Lithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage. Handle with care. Do not expose the device to liquids. Do not attempt to disassemble the device. Do not put device in autoclave. Damaged devices should not be used anymore. WARNING Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. Do not incinerate the devices or expose them to temperatures above 60C (140F). 50 2 IntelliVue CL SpO2 Pod Storage they should be powered off for storage they should be stored in a cool place, ideally between 15C and 25C (60F and 77F) the state of charge should be between 40 and 50%
they should be recharged every six months If unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:
Storing in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20C (-4F) to 60C(140F). Do not store cableless devices in direct sunlight. NOTE Storing the devices at temperatures above 40C (104F) for extended periods of time could significantly reduce the battery's life expectancy. Battery Lifetime Management The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles. To see the date of manufacture and the number of charge-discharge cycles:
1 2 The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the hardkey to scroll through the list. The age of a lithium ion battery begins at the date of manufacture. Select the Battery Smartkey or Main Setup followed by Battery. Press the hardkey to view the battery details. 51 2 IntelliVue CL SpO2 Pod Accessories You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available. WARNING Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. Philips approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. Accessories Compliant with EMC Standards All accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2. IntelliVue CL SpO2 Pod Accessories All listed sensors operate without risk of exceeding 41C on the skin, if the initial skin temperature does not exceed 35C. Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. Part Number 989803165941 989803165921 9898031659311 Description Mobile CL 20 single patient SpO2 Sensors and Cradles for use on pediatric and adult patients
>10 kg Mobile CL 20 single patient SpO2 Sensors for use on pediatric and adult patients >10 kg Mobile CL reusable SpO2 Sensor and Cradles for use on pediatric and adult patients > 15 kg 989803165951 Mobile CL 20 SpO2 Cradles (single patient) 989803165961 989803168861 Mobile CL 50 SpO2 Wristbands (single patient) Mobile CL SpO2 Battery Kit Contents 20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled 20 Single-Patient Mobile CL DSpO2-1A Sensors 1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands 20 Single-Patient Cradles with pre-attached Wristbands 50 Single-Patient Wristbands 1 Battery 1 disassembly tool 1 front housing 1 May not be available in all geographies 52 2 IntelliVue CL SpO2 Pod Maintenance and Troubleshooting WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories You should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:
1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them. 2 WARNING If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philips-
qualified service professionals only. Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Troubleshooting If a device will not switch on when you press a key, place it onto a charger slot on the charging station. If you suspect a problem with an individual measurement device, read the Instructions for Use and double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to. If you suspect an intermittent, system-wide problem call your service personnel. 53 2 IntelliVue CL SpO2 Pod 54 3 3IntelliVue CL NBP Pod To measure NBP, you need Philips standard cuffs, a Mobile CL NBP Cradle and a pouch and extension air hose, or a Mobile CL NBP Cradle and Mobile CL Cuffs. When using Mobile CL Cuffs, the cradle is used to attach the Pod to the cuffs and to allow easy removal of the Pod. Standard Philips cuffs and specialized single-patient and reusable NBP cuffs are available for use with the IntelliVue CL NBP Pod. For details regarding the cuffs and single-patient cradle, refer to IntelliVue CL NBP Pod Accessories on page 94. General Operation of the NBP Pod The following sections describe operation on the NBP Pod itself. For operation from a patient monitor, see Controls Available with a Patient Monitor on page 67. For operation from an Information Center via a telemetry system, see Controls Available with a Telemetry Device on page 68. For operation with IntelliVue GuardianSoftware, see Controls Available with GuardianSoftware on page 68. The NBP Pods have three hardkeys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily. Switching the Devices On The first time an NBP Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on. If the NBP Pod has only been switched off temporarily (see Switching the Device Off on page 17), press any hardkey to turn the device on again. When an NBP Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed. 55 3 IntelliVue CL NBP Pod Screen Layout There are three variations of the Main Screen layout depending on the Alarm status and the general activity level. Standard Layout When assigned to a monitor, telemetry device or a patient in GuardianSoftware:
1 2 Connection status indicator Indicator that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. Battery indicator 3 4 Measurement values 5 Measurement-related symbols (see the Monitoring NBP section for details) Patient identification 6 When not assigned to a monitor or telemetry device:
Connection status indicator Battery indicator 1 2 3 Measurement values 4 Measurement-related symbols (see the Monitoring NBP section for details). The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. 5 Cableless Measurement Device equipment label Alarm Layout If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has been silenced the alarm indicator is shown as a symbol on the right side of the screen. Full length alarm message 1 2 Alarm indicator 56 Low-Activity Screen If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen. 3 IntelliVue CL NBP Pod When a Cableless Measurement Device Cannot be Activated If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged. Using the Hardkeys The IntelliVue Cableless Measurement Devices have three hardkeys: , , . Use and to navigate through SmartKeys and menus and to select items or to silence alarms. The three hardkeys also have an additional function when the key is held down for a couple of seconds:
opens the Add To screen to assign a device (or to unassign it when it is already assigned) opens the SmartKeys menu returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears Using the SmartKeys A SmartKey is a graphical key which appears on the screen and gives you fast access to functions. SmartKeys Menu Press the hardkey (without any screen element highlighted) to get to the SmartKeys menu. Use the and hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the or hardkey at the end of the row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the Exit screen or press the hardkey for a couple of seconds to return to the Main Screen. When the required SmartKey is highlighted, press the key to activate the corresponding function. To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the key. 57 3 IntelliVue CL NBP Pod List of Available SmartKeys SmartKey Text Labels Main Setup
- start/stop manual NBP measurement
- start auto series
- start measurement sequence
- stop current automatic measurement within series stop any NBP measurement and measurement series start NBP STAT measurement start venipuncture (inflate cuff to subdiastolic pressure) set the NBP repetition time Add/Remove device enter Battery menu change Screen enter Profiles menu put the device in standby mode (or power off when pressed for more than two seconds) enter Patient menu enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/
Off/Pause, Alarm Volume. change alarm volume change pulse tone volume access NBP mode selection and setup, with direct start/stop function 58 Using the Main Setup Menu In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get to the Main Setup menu. 3 IntelliVue CL NBP Pod Main Setup NBP Alarms Patient Equipment User Interface Standby Profiles Operating Modes Date, Time Battery Revisions Switching the Device Off To put the device in standby mode, select the Standby SmartKey, then Confirm. If you keep Standby pressed for more than two seconds, you can choose between Standby or Power Off. Standby means that the display is switched off and the measurements are disabled. Use this option if your device is not used temporarily. Press any hardkey to turn the device on again. Power Off means that the device is switched off completely and can only be switched on again by putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping. Auto Standby and Auto Power Off The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings. Operating Modes Your device has four operating modes. Some are passcode protected. Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode. Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring. Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on. Service Mode: Passcode protected, this is for trained service personnel. 59 3 IntelliVue CL NBP Pod When you switch the device on, it starts up in monitoring mode. To change to a different mode:
1 Use the Main Setup SmartKey to get to the Main Setup menu. 2 Select Operating Modes and choose the mode you require. Standby Mode The IntelliVue Cableless Measurement Devices do not have standby mode. However, when connected to a monitor that is in standby mode, the IntelliVue Cableless Measurement Device will show a standby screen. Using the Patient Menu The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data which can be changed at the Cableless Measurement Device, but only when the device is not assigned to a patient monitor or telemetry device. Displaying the Patient Menu To display the Patient menu, select the Patient SmartKey, or select the Main Setup SmartKey followed by Patient. Stop Using a Device for a Patient in the Patient menu select Free Device. To remove a patient from the Cableless Measurement Device, All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor or telemetry device. NOTE Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient. Using the Device for a New Patient To use a device for a new patient, If the device was not free, the existing data will be deleted and the profile set to the default. in the Patient menu, select New Patient. Using Profiles A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol. To select a different profile, 1 2 Selecting New Patient or Free Device will always reset the profile to the default. Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles. Select the required profile from the list. 60 Setting the Date and Time 3 IntelliVue CL NBP Pod Select the Main Setup SmartKey and then Date, Time. If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the date and time on the Cableless Measurement Device, 1 2 Enter the data for date and time one after another. 3 If the time has not been set, --:-- will display on the device. Select Store Date, Time. Battery Status The IntelliVue CL NBP Pods show their battery status on their display both in operating and charging condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging. Battery Status Menu Select the Battery SmartKey or Main Setup followed by Battery using the and keys, then press the key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature. 61 3 IntelliVue CL NBP Pod Connection with Host Systems The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware). IntelliVue Cableless Measurements Use Models With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models:
With a Patient Monitor The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table Controls Available with a Patient Monitor on page 67. In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring. When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See Alarms on page 34 for details. A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor. When assigned to a patient monitor, the admitted patient name is displayed on the NBP Pod. If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl NBP Disconnect. A No Host Monitoring INOP will be displayed on the NBP Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the NBP Pod, but it is not possible to change the alarm settings. With a Fetal Monitor In combination with an Avalon CL Transducer System, the IntelliVue CL NBP Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The NBP Pods are assigned to the fetal monitor by docking them at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use. With a Telemetry Device The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/
TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values. Some of the measurement tasks can be performed remotely from the Information Center. See the table Controls Available with a Telemetry Device on page 68. If the patient name is available at the Information Center, it will be also displayed on the NBP Pod. 62 3 IntelliVue CL NBP Pod When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor. If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: cl NBP Disconnect. A No System Monitor. INOP will be displayed on the NBP Pod, and an INOP tone will sound. With IntelliVue GuardianSoftware The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices. Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table Controls Available with GuardianSoftware on page 68. GuardianSoftware also manages the patient data. If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed on the NBP Pod
(no alarm sound). If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of patient data will be synchronized between the Pods and GuardianSoftware. The only patient management action available directly at the Pod is Free Device. Selecting Free Device removes the current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned. Device Compatibility IntelliVue Patient Monitor - Release H.0 or above Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above IntelliVue Information Center - Release M or above Philips Patient Information Center iX - Release A or above Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above The IntelliVue CL NBP Pods require the following software levels in the associated equipment:
MX40 wearable patient monitor - Revision A.0 or above IntelliVue GuardianSoftware - Revision A.0 or above Availability of Patient Alarms When the IntelliVue CL NBP Pod is used alone, without an assignment to a monitor or telemetry device no patient alarms will be generated. When the IntelliVue CL NBP Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center. When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details. If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See Alarms on page 34 for details. 63 3 IntelliVue CL NBP Pod When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details. When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware. Assigning an IntelliVue Cableless Measurement Device to a Host When an IntelliVue CL NBP Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Cableless Measurement Device must be assigned to that host system. The assignment can be done at the CL NBP Pod itself or at the host system (patient monitor or GuardianSoftware). WARNING Always make sure that the applied CL NBP Pod is assigned to the correct patient. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the NBP Pod, or a cl NBP Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Assignment at the Measurement Device To make an assignment, select:
, or the Add/Remove SmartKey hold the key pressed. This opens the Add To menu which lists the available patient monitors and telemetry devices within the SRR range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds. Telemetry device: A telemetry device must be put into assignment mode by pressing the key on the telemetry device before it can appear in the list. Pressing the key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will 64 take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment. 3 IntelliVue CL NBP Pod Add To Mon 1 Mon 2 Tele 33 Tele 44 1 Select a patient monitor or telemetry system using the and keys. If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device. 2 Activate the assignment by pressing the key twice on the measurement device. The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message. If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this:
1 Select the measurement selection key on the monitor. A prompt message appears with the Confirm and Cancel keys. Select Confirm to deactivate the internal measurement. 2 When the Cableless Measurement Device is assigned, the alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. To unassign the measurement device from the monitor or telemetry system, select the Add/Remove SmartKey, then select Remove From. After confirmation the SRR connection is disconnected. symbol appears on its display indicating that Assignment at the Patient Monitor Assignment at the Patient Monitor Prepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey. At the patient monitor, 1 2 Select the Measurement Selection key. Select the Add cl Msmt pop-up key. This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices:
Select the device which you want to assign to the patient in the monitor. The monitor displays the assignment prompt message. 3 4 If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. When the Cableless Measurement Device is assigned, the alarms from the device will be sent to the patient monitor. symbol appears on its display indicating that 65 3 IntelliVue CL NBP Pod An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor. Assignment with an RFID Reader and Tagged Cableless Devices You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The Respiration Pod has a built-in RFID tag. The NBP Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached. 1 Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. 2 The Cableless Measurement Device is now added to the monitor. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting Replace. If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Assignment at the Fetal Monitor The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station. NOTE When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient. Special Conditions when Working with Fetal Monitors The following special conditions apply when CL NBP Pods are operating with an Avalon Fetal Monitor as a host:
The CL NBP Pods are intended to measure the maternal NBP and Pulse. The patient category is always Adult. The Pulse measurement is always On. The Pulse: On/Off setting is not available. Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available: Use for Transp. is not supported. (Local attended monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver). Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information. 66 3 IntelliVue CL NBP Pod You can use the Remove operation at the host to remove Cableless Measurement Devices, as described in the Avalon Fetal Monitor Instructions for Use. STAT mode is not supported. Accelerated Measurement mode is not supported. Assignment with GuardianSoftware To assign a Cableless Measurement Device to a patient in GuardianSoftware:
1 2 3 On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, Select the patient on the Chalkboard. Take the Cableless Measurement Device from the charger. highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed). 4 Click Use for Patient to assign the device to the patient. Controls Available with a Patient Monitor The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below. Action At the IIC Start/Stop/Stat NBP Change NBP Mode Change NBP Repetition Time Change Alarm Limits Assign NBP Pod Remove NBP Pod Place Device in Standby Alarm Silence Alarm Off/Pause At the Cableless Measurement Device Yes Yes Yes Yes*
Yes Yes Yes No No At the Patient Monitor Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No Yes Yes Yes
* except when SRR connection to host is lost WARNING If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone. 67 3 IntelliVue CL NBP Pod Controls Available with a Telemetry Device The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below. Action At the IIC Start/Stop/Stat NBP Change NBP Mode Change NBP Repetition Time Change Alarm Limits Assign NBP Pod Remove NBP Pod Place Device in Standby Alarm Silence Alarm Off/Pause At the Cableless Measurement Device Yes Yes Yes No Yes Yes No No No NOTE When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The NBP measurement devices assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements. Controls Available with GuardianSoftware The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below. Action At GuardianSoftware Start/Stop/Stat NBP Change NBP Mode Change NBP Repetition Time Assign NBP Pod Remove NBP Pod Place Device in Standby Alarm Silence Alarm Off/Pause At the Cableless Measurement Device Yes Yes Yes Yes Yes No No No The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system. When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage. Trending 68 No No No Yes No Yes No Yes Yes Yes Yes Yes Yes Yes No Yes No 3 IntelliVue CL NBP Pod Monitoring NBP The IntelliVue CL NBP Pod uses the oscillometric method for measuring NBP. The blood pressure measurements determined with this device were clinically validated according to ISO 81060-2 in relation to mean error and standard deviation, when compared to auscultatory measurements (depending on the configuration) in a representative patient population. The fifth Korotkoff sound was used to determine the diastolic pressure for adult/adolescent subjects and the 4th for pediatric subjects. The accuracy of the mean arterial pressure (MAP) was validated using the approximation:
MAPref = (SYSref + 2*DIAref) / 3 with SYSref and DIAref being the blood pressure measured by the auscultatory method. The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30. Introducing the Oscillometric NBP Measurement Oscillometric devices measure the amplitude of pressure changes (oscillations) in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. WARNING Patient Category: Do not use the IntelliVue CL NBP Pod on neonatal patients. The initial inflation pressure and overpressure safety limits are too high for neonatal patients and could cause fractures and bruises. Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Existing Wounds: Do not apply the cuff over a wound as this can cause further injury. Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the benefit of the measurement outweighs the risk. Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff. Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb. CAUTION If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. 69 3 IntelliVue CL NBP Pod Measurement Limitations NBP readings can be affected by the position of the patient, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information. Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible:
with excessive and continuous patient movement such as shivering or convulsions if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias with rapid blood pressure changes with severe shock or hypothermia that reduces blood flow to the peripheries with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery on an edematous extremity. Accelerated Measurement When the accelerated measurement is used the minimum number of oscillations per deflation step is 1, instead of the 2 in the standard measurement. This allows a faster measurement result but requires that the patient keeps the limb in question still. The accelerated measurement is recommended for use when very few or no artifacts are expected, for example with sedated patients. You can see whether the accelerated measurement is in use by looking in the patient monitor's Setup NBP menu. The Accelerated Msmt setting shows whether the accelerated measurement is Off, on for Manual measurements or on for All measurements. You can see this setting in Monitoring Mode but it can only be changed in Configuration Mode. When the accelerated measurement is in use, no pulse rate is derived from NBP. Measurement Modes There are three modes for measuring NBP:
Manual - measurement on demand. Auto - continually repeated measurements (between one minute and 24 hours adjustable interval). Sequence - up to four measurement cycles which will run consecutively, with number of measurements and interval between them configurable for each cycle. Auto and Sequence modes must be set up, before a measurement series can be started. See Enabling Automatic Mode and Setting Repetition Time on page 74 and Enabling Sequence Mode and Setting Up The Sequence on page 75. Additionally, you have the possibility to start an immediate, one-time measurement series at any time:
STAT - rapid series of measurements over a five minute period. Use only on supervised patients. After a STAT measurement series, the monitor returns to the previous mode. If an Auto or Sequence measurement series was running before the STAT measurement, it will continue to run afterwards. Reference Method The measurement reference method is always Auscultatory (manual cuff). For further information, see the Application Note supplied on the documentation DVD. 70 Preparing to Measure NBP with Standard Cuffs 1 Apply the carrying pouch to the patient. 3 IntelliVue CL NBP Pod 2 Apply the cuff to the patient's upper arm at the same level as the heart. If the cuff is not at heart level, you must use the measurement correction formula to correct the measurement. Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the cover is not folded or twisted. A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. 3 Connect the extension air hose to the cuff. 71 3 IntelliVue CL NBP Pod 4 Connect the extension air hose to the cradle. Hold the flat part of the connector vertically when plugging it into the inlet, then twist it clockwise to lock into place. Avoid compression or restriction of pressure tubes. Air must pass unrestrictedly through the tubing. WARNING Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient. 5 Place the NBP Pod into the cradle. 6 Put the NBP Pod into the carrying pouch. Make sure to pinch the velcro enclosures firmly together around the extension hose exiting from the pouch. CAUTION Make sure that the air vent, located next to the air tubing connector on the NBP Pod, is not covered during operation. If air cannot enter the air vent, the pump may be damaged. 72 3 IntelliVue CL NBP Pod WARNING Inspect the application site of the cuff regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or stat measurements. Attaching the Pod Directly to a Mobile CL Cuff As an alternative to using a carrying pouch, you can attach the NBP Pod directly to the cuff. In this case you do not need the extension hose. 1 Attach the cradle to the NBP cuff. 2 Plug the air tubing into the cradle. 3 Apply the cuff to the patient's upper arm. Apply the cuff so that the cradle is located at the outside of the arm. The bladder of the cuff is then automatically over the artery. Insert the NBP Pod into the cradle. 4 Additional Information The following documents contain additional information, depending on which accessories you are using:
Mobile CL Reusable NBP Cuffs Instructions for Use Mobile CL Single-Patient NBP Cuffs Instructions for Use Mobile CL NBP Cradle Instructions for Use Mobile CL Extension Air Hose Instructions for Use Recommendations For Measurements Used in Diagnosis of Hypertension To make a measurement for use in the diagnosis of hypertension, follow the steps below:
1 Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor and back and arm supported. 2 Ask the patient to relax and not talk before and during the measurement. 3 If possible, wait 5 minutes before making the first measurement. 73 3 IntelliVue CL NBP Pod Starting and Stopping Measurements Use the setup menu or SmartKeys to start and stop measurements. Action to be Performed Start manual measurement Start Auto series Start measurement sequence Start STAT measurement NBP Setup menu Start/Stop Start NBP Stat Stop Manual measurements Start/Stop Stop current Auto/sequence measurement Start/Stop Stop current STAT measurement and end STAT mode Start/Stop Stop Auto, Manual or STAT measurement, end STAT mode AND Auto/Sequence series Stop All SmartKeys Start/Stop Start NBP STAT Start/Stop Start/Stop Start/Stop Stop All Depending on the configuration of the NBP Auto/Sequence series, measurements are automatically started within 3 seconds (Automatic Start set to Fast) or 3 minutes (Automatic Start set to Slow) after the NBP Pod has been inserted into the cradle. With Automatic Start set to Off, the Auto/Sequence series have to be started manually. No pulse can be derived from the NBP measurement in Accelerated and STAT mode. If accelerated measurement mode is configured for manual or manual and Auto/Sequence measurements, make sure that the patient is not moving during the measurements. CAUTION Use clinical judgment to decide whether to perform repeated series of STAT measurements because of the risk of purpura, ischemia and neuropathy in the limb with the cuff. Enabling Automatic Mode and Setting Repetition Time 1 2 In the NBP menu, select Mode and select Auto from the pop-up menu. For an automatic measurement, select Repeat and set the time interval between two measurements. 74 Enabling Sequence Mode and Setting Up The Sequence 3 IntelliVue CL NBP Pod 1 2 3 4 In the NBP menu, select Mode and select Sequence from the pop-up menu. Select Setup Sequence to open the Setup Sequence menu. Up to four measurement phases can be setup which will run consecutively. For each phase you can set the number of measurements and the interval between them. If you want to run less than four phases in a sequence, you can set the number of measurements for one or more phases to Off. Select each phase in turn (A, B, C and D) and select the number of measurements and the time interval between the measurements. To have measurements continue after the sequence, set the number of measurements for your last phase to Cont and this phase will run indefinitely. CAUTION Be aware that, if none of the phases are set to Cont, NBP monitoring will end after the last measurement of the last phase. When the NBP measurement mode is set to Sequence, the repetition time for Auto mode cannot be changed. Announcement Tone:
Depending on the configuration of the NBP Pod, a tone before each measurement announces the next measurement. Please inform the patient to stop moving, and especially stop moving the arm with the cuff, when the tone sounds and the cuff inflates in order to allow a fast and accurate measurement. Understanding the NBP Numerics and Symbols Systolic/Diastolic pressure 1 2 Mean pressure 3 4 5 Measurement mode (see below) 6 Alarms Off symbol for Pulse (Pulse from NBP does not Pulse rate Pulse rate indicator have alarm capability, therefore it cannot be switched on) Timestamp 7 8 Alarms Off symbol for NBP Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. Measurement modes with a series of measurements can be indicated with two different symbols:
indicates that a series is running and shows the relative time to the next measurement. indicates that auto or sequence mode is selected but the measurement series has not yet started. An S in front of the symbol indicates Sequence mode and an A, B, C or D indicates which phase of the sequence is currently running. 75 3 IntelliVue CL NBP Pod During Measurements The cuff pressure is displayed instead of the timestamp. Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level, to the displayed value Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or Deduct 1.9 mmHg (0.25 kPa) for each inch lower. When Unexpected Values are Measured When values measured are higher or lower than expected, check the following potential causes:
Possible Cause The patient was talking or moving before or during the measurement. The incorrect cuff size was used or the cuff was not at heart level Measurement limitations have not been taken into account. Solution Allow the patient to rest quietly, then try again after three to five minutes. Check the cuff size, level, and position then repeat the measurement. Check the list in Measurement Limitations on page 70. Switching Pulse from NBP On/Off In the process of making the NBP measurement, a pulse value can be derived and displayed. The pulse value is displayed together with the time the measurement was made. After one hour the value becomes invalid. There are no alarms associated with pulse from NBP. When the accelerated measurement is in use, no pulse value can be derived. To switch the display of the pulse value on or off:
In the NBP menu select Pulse. Assisting Venous Puncture In the NBP menu select Veni Puncture, or select the Veni Puncture SmartKey. Puncture vein and draw blood sample. You can use the NBP cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time
(adult/pediatric 170 seconds) if you do not deflate it. 1 2 3 Reselect Veni Puncture to deflate the cuff. During measurement, the NBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. Calibrating NBP NBP is not user-calibrated. NBP pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Guide for details. 76 Alarms 3 IntelliVue CL NBP Pod The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs). Patient Alarms Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red alarms, or medium priority alarms, also called yellow alarms. Technical Alarms (INOPs) Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection. Most INOPs are low priority, however there are a small number of INOPs which, due to their severity, are medium or high priority. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components:
The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter IntelliVue CL NBP Pod Specifications on page 135 for the system alarm delay specification of the Cableless Measurement Device. The alarm delay configured for a specific measurement is normally a fixed time. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe. NOTE If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02. Visual Alarm Indicators WARNING No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor
(unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. 77 3 IntelliVue CL NBP Pod Alarm Message Alarm messages are displayed in black on a light gray background in the alarm status area at the top of the screen indicating the source of the alarm and coded according to their severity. If more than one measurement is in an alarm condition, the message changes every few seconds, and has an arrow (
) at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. An alarm message that appears is automatically highlighted. Use the key to silence the message. A Silence message is displayed at the bottom of the screen and highlighted. Press again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen. Alarm States Depending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device:
Icon Description No local alarming on Cableless Measurement Device. The device is connected to a host monitor or telemetry device and has no visual or audible patient alarm indicators. The device will only display INOP messages. Alarms are switched off. Alarm volume is set to 0. Audible Alarm Indicators Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume. WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware. When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to). 78 Silencing an Alarm To silence an alarm, press the key. This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed on the right hand side of the screen. 3 IntelliVue CL NBP Pod Full length alarm message 1 2 Alarm indicator When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device. Otherwise you will get a technical alarm (cl NBP Disconnect) that can not be silenced at the telemetry device. You will then have to reboot the telemetry device to remove the message. Displaying a List of Current Alarms To display a list of the currently active alarms, 1 2 Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select Alarm Messages. Setting the Volume of the Alarm Tone To set the volume for the Alarm tone, 1 2 Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on your configuration. If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray of the Cableless Measurement Device screen:
Minimum Volume for No Host Monitoring INOP If your device is connected to a host monitor, and the connection is interrupted, the INOP message No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the device alarm volume is set to zero. Alarm Reminder If Reminder is configured on your device, you will get an audible reminder of alarm conditions that remain active after you have silenced the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. 79 3 IntelliVue CL NBP Pod Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off. To view the alarm pause setting chosen for your unit, 1 2 Check the setting. This setting can only be changed in Configuration Mode. In the SmartKeys Menu select Main Setup, Alarms, then OffDurat. To Pause or Switch Off Alarms Select the Paused. If your device is configured to infinite pause time, selecting this option switches alarms off. key in the SmartKeys Menu followed by Alarms. Press the hardkey to switch to Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the key Alarm indication starts again automatically after the pause period expires. If the device is configured to stay again. paused infinitely, you must select again to restart alarm indication. Choosing the NBP Alarm Source You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. In the NBP menu, select Al. from and choose from:
Menu Option Sys. Dia. Mean Sys & Dia Dia & Mean Sys & Mean Sys&Dia&Mean Displayed as Sys. Dia. Mean S & D D & M S & M S&D&M Pressure value monitored systolic diastolic mean systolic and diastolic in parallel diastolic and mean in parallel systolic and mean in parallel all three pressures in parallel If Mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived an NBP Measure Failed INOP will be displayed. 80 3 IntelliVue CL NBP Pod Alarm Limits The alarm limits you set determine the conditions that trigger limit alarms. WARNING Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Adjusting the Alarm Limits Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by NBP). 1 2 Depending on your alarm source:
a. b. Select Sys.High, Dia.High and/or MeanHigh then choose the high alarm limit. Select Sys. Low, Dia. Low and/or Mean Low then choose the low alarm limit. Latching Alarms The alarm latching setting for your device defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the device after the alarm condition ends. The indication lasts until you acknowledge the alarm. Viewing the Alarm Latching Settings In the Main Setup menu, select Alarms. To see the alarm latching setting for your device, 1 2 Here you can see the Visual Latching and Audible Latching settings. This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings:
Visual Latching Red&Yellow Red&Yellow Red&Yellow Red Only Red Only Off Audible Latching Red&Yellow Red Only Off Red Only Off Off Alarm Latching Behavior As NBP is an aperiodic parameter, "Alarm condition no longer present" means either that for a measurement in alarm the alarm limits are changed in such a way that the value is now within the limits, or that a new measurement is done with a value within the limits. 81 3 IntelliVue CL NBP Pod Red & Yellow Measurement Alarms Non-latching alarms Visual and audible latching Visual latching, audible non-latching Alarm has not been acknowledged. Alarm condition still present. Alarm condition no longer present. Alarm tone on. Alarm message. Alarm tone on. Alarm All audible and visual alarm indicators automatically stop. message. Alarm tone on. Alarm message. Alarm has been acknowledged. Alarm condition still present. Alarm condition no longer present. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. Alarm tone on. Alarm message. Alarm message. Audible alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. All INOPs are non-latching. NBP specific INOPs generated by the CL Pod are latching. Testing Alarms When you switch the CL NBP Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. Alarm Behavior at Power On If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See Switching the Device Off on page 17 and Using Profiles on page 18 for details. When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings. After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct Profile and patient category. Reference List of Patient Alarms Source NBP NBP Alarm Message, Indication
** NBPs High
** NBPd High
** NBPm High
** NBPs Low
** NBPd Low
** NBPm Low Reference List of all INOPs Condition The measured NBP value is above the high alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured NBP value is below the low alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. 82 INOP Message, Indication Batt Incompatible INOP tone Batt Malfunction INOP tone Battery Empty INOP tone Battery Low INOP tone Check Batt Temp INOP tone Check Battery INOP tone Check Charger I/F INOP tone Source Battery Battery Battery Battery Battery Battery Battery cl NBP ChkSettings INOP tone Cableless Measurement Device Cableless Measurement Device NBP cl NBP Disconnect only at the host Cuff Not Deflated Numeric is replaced by -?-
INOP tone During this INOP, alarms cannot be paused or switched off. 3 IntelliVue CL NBP Pod What to do Battery cannot be used with this Cableless Measurement Device. Replace battery with one that has been approved for use with this Cableless Measurement Device. Contact your service personnel. Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel. The remaining monitoring time is below 30 minutes. Charge battery. The remaining monitoring time is below 2 hours. The temperature of the battery is critically high. Check that Cableless Measurement Device is not covered and not exposed to a heat source. If INOP persists, remove Cableless Measurement Device from patient and contact your service personnel. The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel to replace the battery. Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. If this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. The NBP Pod has lost the SRR connection to the telemetry device or the patient monitor. The NBP cuff pressure has exceeded 15 mmHg (2 kPa) for more than 3 minutes. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try repeating the measurement. You can acknowledge the INOP, but the INOP message remains visible until the next NBP measurement is started or the Stop All SmartKey is selected. 83 3 IntelliVue CL NBP Pod INOP Message, Indication NBP Check Cuff Numeric is replaced by -?-
INOP tone Source NBP NBP NBP NBP NBP NBP NBP NBP Cuff Overpress Numeric is replaced by -?-
INOP tone During this INOP, alarms cannot be paused or switched off. NBP Equip Malf Numeric is replaced by -?-
INOP tone NBP Interrupted Numeric is replaced by -?-
INOP tone NBP Measure Failed Numeric is replaced by -?-
INOP tone NBP Neo Patient?
Numeric is replaced by -?-
INOP tone No Cradle Numeric is replaced by -?-
INOP tone 84 What to do Check if cuff is connected to the NBP Pod and cuff is applied to the patient; check tubing and cuff for leakage. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the maximum time for inflation is exceeded or when there is a significant change in inflation time between two successive measurements in auto and sequence mode. The NBP cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try restarting the measurement. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Remove the NBP Pod and cuff from the patient. The NBP hardware is faulty. Contact your service personnel. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time for deflation or the total measurement. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the condition and suitability of the patient for NBP monitoring. Use another cuff to continue measuring. The patient monitor that the NBP pod is assigned to is in neonatal mode or a neonatal cuff has been detected. The monitor must be in adult or pediatric mode. The NBP Pod is not in the cradle. You can silence this INOP, but the INOP message remains visible until the NBP Pod is inserted into the cradle and the next measurement is started or the Stop All SmartKey is selected. If INOP appears with the NBP Pod inserted into the cradle, remove and replace the cradle. INOP Message, Indication No Host Monitoring INOP tone Source Cableless Measurement Device No System Remove From Pat INOP tone Service Battery INOP tone Cableless Measurement Device Cableless Measurement Device Battery 3 IntelliVue CL NBP Pod What to do There is a problem with the communication to the assigned patient monitor and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection. Displayed on the Cableless Measurement Device. The temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery. 85 3 IntelliVue CL NBP Pod Local Attended Monitoring When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO2 and NBP Pods can be used for local attended monitoring. This is for situations where you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor
(disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (cl Alarms On/
Off) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on. Local Attended Monitoring Enabled By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A cl NBP Disconnect INOP is shown at the monitor if the SRR connection is lost and the transport mode has not been activated. CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model):
SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
Indication of physiological and technical alarms from CL Pods CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:
No SRR connection At the CL Pod:
Indication of technical and physiological alarms At the monitor:
No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection. 86 3 IntelliVue CL NBP Pod Local Attended Monitoring Disabled The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no cl NBP Disconnect INOP is shown at the monitor in this scenario. CL Pod connected to a patient monitor and CL Measurement Alarms Off:
SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods. CL Pod disconnected from patient monitor and CL Measurement Alarms Off:
No SRR connection At the CL Pod:
Indication of technical alarms only At the monitor:
No indication of physiological and technical alarms from CL Pods. 87 3 IntelliVue CL NBP Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On 1 Standard Use Model 2 Local Attended Monitoring
->
Caregiver activates
'Use for transport'
<-
Caregiver activates
'Use with monitor'
SRR connection no SRR connection Action / Event Situation Standard Use Model:
normal operation, no special action CL Pod connected to the patient monitor (1) Alarm Availability at CL Pod Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Alarm Availability at Patient Monitor Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) 88 Patient is in transport without connection to the host system, caregiver attends the patient
(2) Technical alarms
(own) Physiological alarms
(own) 3 IntelliVue CL NBP Pod Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod Patient returns from transport. Back to the standard use model (1) Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) Activation of Local Attended Monitoring:
Caregiver activates Local Attended Monitoring and disconnects CL Pod temporarily by setting Use for Transp. in the Patient Monitor's Equipment window Deactivation of Local Attended Monitoring:
Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting Use with Monitor in the patient monitor's Equipment window Special Case:
Connection lost while in Standard Use Model Action / Event Situation Alternative Use Model:
CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiver No Host Monitoring INOP at CL Pod cl NBP Disconnect INOP at patient monitor Local Attended Monitoring is automatically activated (2) Alarm Availability at CL Pod Technical alarms
(own) Physiological alarms
(own) Alarm Availability at Patient Monitor Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod 89 3 IntelliVue CL NBP Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off 3 Patient within Range 4 Patient Mobile
->
Patient mobile
<-
Patient back SRR connection no SRR connection Action / Event Situation Connected, but no CL Alarms
(CL Measurement Alarms Off):
normal operation, no special action CL Pod connected to the patient monitor (3) Alarm Availability at CL Pod Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Alarm Availability at Patient Monitor Technical alarms
(own + from Pod) Physiological alarms
(own) 90 3 IntelliVue CL NBP Pod Patient is leaving the vicinity of the monitor:
no special action Patient is mobile without connection to the host system
(4) Technical alarms
(own) No physiological alarms Alarms Off icon is displayed in front of each numeric:
Technical alarms
(own) Physiological alarms
(own) No alarms from CL Pod Patient returns to the vicinity of the monitor:
no special action Patient returns. Back to connected status (3) Technical alarms
(own) No physiological alarms No Local Alarming icon is displayed:
Technical alarms
(own + from Pod) Physiological alarms
(own + from Pod) NBP Default Settings These are the most important default settings of your IntelliVue CL NBP Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in Configuration Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will overwrite the settings defined at the Pod. NBP Settings Mode Al. from Sys.High Dia.High MeanHigh Sys. Low Dia. Low Mean Low Alarms NBP Repeat Time Pulse Unit Done Tone Start Time VP Pressure Reference Adult Auto Sys. 160 90 110 90 50 60 On On 10 min On mmHg Off Synchronized 60 mmHg Auscultatory Pedi Auto Sys. 120 70 90 70 40 50 On On 10 min On mmHg Off Synchronized 40 mmHg Auscultatory 91 3 IntelliVue CL NBP Pod NBP Settings Aging Time Color AnnouncementTone Automatic Start Accelerated Msmt Adult 10 min Red Off Off Off Pedi 10 min Red Off Off Off Integrated Battery Handling Only qualified and authorized service personnel (biomedical engineers or technicians) should change batteries. Battery Care Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed. Activity Perform a visual inspection Charge the battery When to perform Before using the IntelliVue Cableless Measurement Device Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. When not in use for an extended period of time, or when the device is shipped. Store the device in a state of charge in the range of 40-50% and power off the device completely. Handling Precautions Lithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage. Handle with care. Do not expose the device to liquids. Do not attempt to disassemble the device. Do not put device in autoclave. Damaged devices should not be used anymore. WARNING Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. Do not incinerate the devices or expose them to temperatures above 60C (140F). 92 3 IntelliVue CL NBP Pod Storage they should be powered off for storage they should be stored in a cool place, ideally between 15C and 25C (60F and 77F) the state of charge should be between 40 and 50%
they should be recharged every six months If unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:
Storing in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20C (-4F) to 60C(140F). Do not store cableless devices in direct sunlight. NOTE Storing the devices at temperatures above 40C (104F) for extended periods of time could significantly reduce the battery's life expectancy. Battery Lifetime Management The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles. To see the date of manufacture and the number of charge-discharge cycles:
1 2 The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the hardkey to scroll through the list. The age of a lithium ion battery begins at the date of manufacture. Select the Battery Smartkey or Main Setup followed by Battery. Press the hardkey to view the battery details. Accessories You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available. WARNING Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. Philips approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. Accessories Compliant with EMC Standards All accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2. 93 3 IntelliVue CL NBP Pod IntelliVue CL NBP Pod Accessories Mobile CL Cuffs and Accessories Part Number Description 989803163171 989803163191 989803163211 989803163181 989803163201 989803163221 989803163251 989803163131 989803187431 989803163261 Mobile CL Reusable Small Adult Cuff Mobile CL Reusable Adult Cuff Mobile CL Reusable Large Adult Cuff Mobile CL Single-Patient Small Adult Cuff Mobile CL Single-Patient Adult Cuff Mobile CL Single-Patient Large Adult Cuff Mobile CL NBP Cradle Kit Mobile CL Extension Air Hose, 1.0 m Mobile CL Air Hose - Bayonet Connector Mobile CL NBP Battery Kit 989803137831 989803140371 Telemetry Pouch with window Telemetry Pouch with window 989803101971
(9300-0768-050) 989803101981
(9300-0768-200) White Telemetry Pouch with Snaps; box of 50 White Telemetry Pouch with Snaps; 4 boxes of 50 Comfort Care Reusable Cuffs Description Infant cuff Pediatric cuff Small adult cuff Small adult cuff, XL Adult cuff Adult cuff, XL Large adult cuff Large adult cuff, XL Part Number M1571A M1572A M1573A M1573XL M1574A M1574XL M1575A M1575XL 94 Limb Circumference Range 21 - 27 cm 26.0 - 34.5 cm 33.5 - 45.0 cm Contents 1 cuff 1 cuff 1 cuff 21 - 27 cm 20 cuffs 26.0 - 34.5 cm 20 cuffs 33.5 - 45.0 cm 20 cuffs
-
-
-
-
-
-
-
-
20 cradles 1 extension air hose 1 adapter air hose 1 Battery 1 disassembly tool 1 front housing 50 pouches 4 boxes of 50 pouches 50 pouches 4 boxes of 50 pouches Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.0 cm 20.5 - 28.0 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 34.0 - 43.0 cm 34.0 - 43.0 cm 3 IntelliVue CL NBP Pod Limb Circumference Range 42.0 - 54.0 cm Part Number M1576A M1577A M1578A M1579A Description Thigh cuff Kit of small cuffs (M1571A to M1574A) Kit of large cuffs (M1573A to M1576A) Kit of all cuffs (M1571A to M1576A) Easy Care Reusable Cuffs Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm 35.0 - 45.0 cm 44.0 - 56.0 cm Part Number M4552B M4552B5 M4553B M4553B5 M4554B M4554B5 M4555B M4555B5 M4556B M4556B5 M4557B M4557B5 M4558B M4558B5 M4559B M4559B5 864288 864289 864290 864291 Description Infant cuff Pack of 5 M4552B cuffs Pediatric cuff Pack of 5 M4553B cuffs Small adult cuff Pack of 5 M4554B cuffs Adult cuff Pack of 5 M4555B cuffs Adult cuff, XL Pack of 5 M4556B cuffs Large adult cuff Pack of 5 M4557B cuffs Large adult cuff, XL Pack of 5 M4558B cuffs Thigh cuff Pack of 5 M4559B cuffs Assortment pack of one small adult, one adult, one large adult and one thigh cuff Assortment pack of one infant, one pediatric, one small adult and one adult cuff Assortment pack of one infant, one pediatric, one small adult, one adult, one large adult and one thigh cuff Assortment pack of one small adult, one adult, one adult XL, one large adult, one large adult XL and one thigh cuff Multi Care Cuffs Part Number 989803183311 989803183321 989803183331 989803183341 989803183351 Description Infant cuff Pediatric cuff Small adult cuff Adult cuff Adult cuff, XL Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.0 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 95 Limb Circumference Range 34.0 - 43.0 cm 42.0 - 54.0 cm Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm 35.0 - 45.0 cm 44.0 - 56.0 cm Limb Circumference Range 14.0 - 21.5 cm 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.5 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 34.0 - 43.0 cm 3 IntelliVue CL NBP Pod Part Number 989803183361 989803183371 Description Large adult cuff Thigh cuff Single Patient, Gentle Care Cuffs Part Number M4572B M4573B M4574B M4575B M4576B M4577B M4578B M4579B Description Infant cuff Pediatric cuff Small adult cuff Adult cuff Adult cuff, XL Large adult cuff Large adult cuff, XL Thigh cuff Single Care Cuffs Part Number 989803182281 989803182291 989803182301 989803182311 989803182321 Value Care Cuffs Part Number 989803160811 989803160821 989803160831 989803160841 989803160851 989803160861 Description Pediatric cuff Small adult cuff Adult cuff Adult cuff, XL Large adult cuff Description Infant cuff Pediatric cuff Small adult cuff Adult cuff Adult cuff, XL Large adult cuff 96 3 IntelliVue CL NBP Pod Maintenance and Troubleshooting WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories You should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:
1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them. 2 WARNING If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philips-
qualified service professionals only. Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Troubleshooting If a device will not switch on when you press a key, place it onto a charger slot on the charging station. If you suspect a problem with an individual measurement device, read the Instructions for Use and double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to. If you suspect an intermittent, system-wide problem call your service personnel. 97 3 IntelliVue CL NBP Pod 98 4 4IntelliVue CL Respiration Pod For respiration measurement, attach the Cableless Respiration Pod to the patient's left costal arch using the Mobile CL Respiration Pod Attachment. As an option, the Respiration Pod also provides pulse measurement. The CL Respiration Pod also provides information about patient posture (positions like supine, prone, upright,...) and activity (e.g. very high or very low activity). For details regarding the adhesive attachment (Mobile CL Respiration Pod Attachment), refer to IntelliVue CL Respiration Pod Accessories on page 111. General Operation of the Respiration Pod The IntelliVue CL Respiration Pod does not have a display and is generally operated via the host system
(e.g. patient monitor). The Pod reports the measured values and status information to the host system via SRR. The IntelliVue CL Respiration Pod has a multi-color LED and a single operation key to display states and allow some basic operation locally. Putting the Pod into Operation The first time a CL Respiration Pod is used, place it on the IntelliVue CL Charging Station. This will automatically switch the device on, and the device will become visible to the host (patient monitor or GuardianSoftware). Checking the Battery Status Press the key once to check the battery status:
Status Battery OK Battery low Battery empty Battery or system malfunction LED green yellow red cyan If the LED is blinking, this means that the Pod is currently not assigned to a host. 99 4 IntelliVue CL Respiration Pod Recharging the Pod To recharge the pod, place it on the charging station. During loading, the pod's LED shows the status:
Status Battery full (90%) Battery loading Battery malfunction LED green yellow cyan Power Off To power off the IntelliVue CL Respiration Pod, take the device from the charging station, then press and hold the key on the pod for five seconds until the LED blinks red. Release the key and press it again to confirm power off. The LED will switch to solid red and fade out. To switch it back on, you must place the device on a charging station. Use this option when the device is not used for a longer time or prepared for storage or shipping. Connection with Host Systems The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors or GuardianSoftware). IntelliVue Cableless Measurements Use Models With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are two typical use models:
With a Patient Monitor The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table Controls Available with a Patient Monitor on page 102. In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring. A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor. If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl Resp Disconnect. With IntelliVue GuardianSoftware The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices. Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table Controls Available with GuardianSoftware on page 103. GuardianSoftware also manages the patient data. If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. 100 4 IntelliVue CL Respiration Pod Device Compatibility The IntelliVue CL Respiration Pod requires the following software levels in the associated equipment:
Patient Monitor - Release J.2 or above IntelliVue GuardianSoftware - Revision B.0 or above The IntelliVue CL Respiration Pod Pediatric Mode requires the following software levels in the associated equipment:
Patient Monitor - Release M.0 or above IntelliVue GuardianSoftware - Revision D.0 or above Availability of Patient Alarms When the IntelliVue CL Respiration Pod is assigned to a host and a short range radio connection exists, alarms will be announced at the host device. When assigned to a patient monitor: Alarm messages will be displayed and audible alarm indicators sounded at the patient monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details. When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are derived. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware. Assigning an IntelliVue Cableless Measurement Device to a Host When an IntelliVue CL Respiration Pod is used with a host system (patient monitor or GuardianSoftware), the Pod must be assigned to that host system. The assignment must be done at the host system. WARNING Always make sure that the applied CL Respiration Pod is assigned to the correct patient. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. 101 4 IntelliVue CL Respiration Pod Assignment at the Patient Monitor Manual Assignment Prepare the Pod for assignment by pressing the hardkey once (LED shows battery and assignment status). At the patient monitor, 1 Open the Add cl Measurement window, e.g. by using the measurement selection key followed by the Add cl Msmt pop-up key. The available Cableless Measurement Devices are shown in the window. Select the device which you want to assign to the patient on the monitor. The monitor displays the assignment prompt message. 2 3 When the Cableless Measurement Device is assigned, the LED changes from blinking to solid. An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor. Assignment with an RFID Reader and Tagged Cableless Devices You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The Respiration Pod has a built-in RFID tag. 1 Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. 2 The Cableless Measurement Device is now added to the monitor. If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Assignment with GuardianSoftware To assign a Cableless Measurement Device to a patient in GuardianSoftware:
1 2 3 On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, Select the patient on the Chalkboard. Take the Cableless Measurement Device from the charger. highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed). 4 Click Use for Patient to assign the device to the patient. Controls Available with a Patient Monitor The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below. Action At the IIC At the Cableless Measurement Device Yes No No No No At the Patient Monitor Yes Yes Yes Yes Yes No No No No No Start Resp/Pulse Measurement Change Measurement Mode Change Repetition Time Change Alarm Limits Assign Respiration Pod 102 Action Remove Respiration Pod Dynamic Repetition Mode On/Off Posture On/Off Activity On/Off Alarm Silence Alarm Off/Pause At the Cableless Measurement Device Yes No No No No No 4 IntelliVue CL Respiration Pod At the Patient Monitor At the IIC Yes Yes Yes Yes Yes Yes No No No No Yes Yes WARNING If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. Keep the patient monitor with the patient during transport. Controls Available with GuardianSoftware The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below. Action At GuardianSoftware Start Resp/Pulse Measurement Change Measurement Mode Change Repetition Time Change Alarm Limits Assign Respiration Pod Remove Respiration Pod Dynamic Repetition Mode On/Off Posture On/Off Activity On/Off Technical Alarm Silence At the Cableless Measurement Device Yes No No No No Yes No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Trending The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system. When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage. 103 4 IntelliVue CL Respiration Pod Monitoring Respiration The CL Respiration Pod derives the respiration and pulse signal from the chest and abdomen movements measured with a built-in acceleration sensor. The CL Respiration Pod gets attached with a Mobile CL Respiration Pod Attachment to the left costal arch on the patient's chest. When configured, the CL Respiration Pod provides information on the basic patient posture and patient activity. Various postures such as supine, upright and lying on left/right side are detected and updated after a posture change has occurred and posture is stable again. The activity is determined once per second, and an average activity level between 0 and 10 is reported once per minute to the connected host system. The activity status information provides only an approximate indication of the actual patient activity. WARNING The CL Respiration Pod is not an apnea monitor and does not provide apnea alarming. Excessive patient movement can interfere with the measured signal. This may result in inaccurate measurements. The CL Respiration Pod does not provide continuous measurement. When configured in frequent mode, the fastest update rate for pulse is 8 sec. If the patient has a condition where the respiration rate approaches the upper limit of the measurement range (60 rpm), use other means of respiration rate measurement. Do not use the CL Respiration Pod in an environment where continuous monitoring is needed, such as intensive care units or operating rooms, because life-critical events might be missed due to the intermittent mode of measurement. Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated. Measurement Modes There are three different modes available for performing respiration/pulse measurements: Manual Mode, Automatic Mode and Frequent Mode. The mode can only be set on the host system:
Manual Mode - a single respiration and pulse measurement is performed when a measurement is started at the host or when the key on the Respiration Pod is pressed (key must be pressed twice if the LED is off). Automatic Mode - respiration and pulse measurements are performed with an interval between them. The interval is selected at the host. The first measurement starts immediately after entering the automatic measurement mode. If configured: When the respiration rate rises above or falls below the defined alarm limits, the measurement mode changes temporarily to frequent mode. The automatic mode will resume if the respiration rate readings are valid for at least 1 minute and no respiration rate reading within the last minute violates the respiration rate alarm. Frequent Mode - respiration and pulse measurement is active all the time. The respiration rate is updated with every new detected breath. The shortest update interval for the pulse rate is 8 seconds. If Dynamic Repetition is enabled (this is setting available in Configuration mode, see IntelliVue Patient Monitor Configuration Guide for details), and the respiration rate violates the high or low respiration rate limit, the measurement switches automatically to Frequent mode. As soon as the respiration rate values are within the limits again, and the values are valid for at least 1 minute, Dynamic Repetition switches back to Automatic mode. 104 Assigning the Pod 4 IntelliVue CL Respiration Pod Take the pod from the charging station. The multi-color LED blinks if the pod is not assigned to a host system. When working with a patient monitor:
Go to the patient monitor you want to use and select Add cl Msmt. The LED on the pod changes from blinking to solid. When working with GuardianSoftware:
In GuardianSoftware:
1 2 On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list. Select the patient on the Chalkboard. The LED on the Respiration pod blinks. 3 Click Use for Patient to assign the pod to the patient. Attaching the Pod to the Patient 1 Put the pod front side up onto the adhesive attachment according to the positioning markers. 2 Remove the protective cover from the strap with the adhesive patch. 3 Fold the straps over the front of the pod, beginning with the strap that has no adhesive patch. 105 4 IntelliVue CL Respiration Pod 4 Fold the second strap over the pod and make sure that the pod is securely and tightly enclosed by the straps. The arrow symbols on the upper strap must be in line with the end of the lower strap:
5 Remove the protective cover from the back of the adhesive attachment. 6 Place the pod on the patient's skin in the region of the left costal arch, with the operation key facing upwards. Press down the adhesive attachment all around the pod. CAUTION The patient's skin should be dry, clean and free of excessive hair. Make sure that the CL Respiration Pod is attached the right way round, with the operation key facing upwards. Otherwise, the posture detection will not provide correct readings. 106 4 IntelliVue CL Respiration Pod WARNING Do not use an adhesive attachment on a patient with a history of skin irritation, allergies or hypersensitivity to adhesives. Do not use on patients with lesions, infections or skin inflammations. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. After use, clean the patient's skin to remove residual adhesive. Always make sure that the attached pod is assigned to the correct patient. For this purpose, it may be helpful to put the equipment label on the pod (for example by using a stick-on label) and to write the patient name on the adhesive attachment. Do not reuse an adhesive attachment on another patient due to risk of cross-infection. Measuring Respiration If the LED is on, press the key once to start a measurement. If the LED is off, press the key twice. Alternatively, start the measurement from the host system. If the measurement has been started directly at the pod, the LED blinks white while the measurement is in progress. When the measurement has finished successfully: The LED changes to solid white. If a measurement fails: The LED blinks white quickly. For a description of the way the measurement results are displayed on the host (Monitor or GuardianSoftware), see the Instructions for Use of the product used as a host. Unassigning the Respiration Pod To unassign the CL Respiration Pod from a host:
Put the pod on the IntelliVue CL Charging Station or:
Keep the key pressed for 2 seconds, until the LED is blinking yellow. Press the key once more to confirm. LED changes to solid yellow and fades out (CL Respiration Pod unassigned). Posture and Activity Information The CL Respiration Pod can also provide information on basic patient posture (body positions). The patient's position is determined and the corresponding information is displayed at the host:
Supine Prone Lying Left (lying on left side) Lying Right (lying on right side) Lying (unspecific) Upright Reclined Forward Upside Down Sitting Standing 107 4 IntelliVue CL Respiration Pod Rolling (in bed; example: patient is agitated) Walking Wheelchair (unassisted) Additionally, the activity level is displayed at the host as a numerical value that ranges in normal operation between level 1 (very low activity) and level 10 (very high activity). Activity level 0 indicates that no physiological signal can be detected (for example when the device has fallen off and is lying on the ground). NOTE The information on basic patient posture and activity is not intended for monitoring or diagnostic purposes. The basic patient posture and activity information is only for reference, showing clinical personnel the approximate posture and activity status of the patient. The activity level does not provide information on a specific activity pattern (e.g. if a patient is walking, or if a patient is rolling over in bed). The activity information is also not intended to recognize abnormal body movements caused by specific diseases, like Parkinsons disease, or other neurological conditions. Technical Alarms (INOPs) Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric on the host monitor. The IntelliVue CL Respiration Pod does not provide any INOP displays or sounds locally at the device itself. INOPs will be announced visually and audibly at the host monitor. Some INOPs have a severity indication: !! for a medium severity INOP and !!! for a high severity INOP. Reference List of all INOPs INOP Message, Indication Can't Analyze cmRR Can't AnalyzePulse cl Resp Batt Empty INOP tone cl Resp Batt Incmp INOP tone cl Resp Batt Low INOP tone cl Resp Batt Malf INOP tone cl Resp Batt Temp INOP tone cl Resp Check Batt INOP tone cl Resp Chk Sett INOP tone Source Resp Resp Battery Battery Battery Battery Battery Battery Resp 108 What to do Unable to analyze respiration signal Unable to analyze pulse signal The remaining monitoring time is below 30 minutes. Charge battery. Battery cannot be used with this Cableless Measurement Device. Contact your service personnel. The remaining monitoring time is below 2 hours. Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel. The temperature of the battery is critically high. Remove Cableless Measurement Device from patient and contact your service personnel. The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel. If this INOP appears, check the Cableless Measurement Device and patient settings before you resume taking measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. INOP Message, Indication cl Resp Disconnect cl Resp Remove INOP tone cl Resp Serv Batt INOP tone Source Resp Resp Battery Resp Resp clResp License Req cmResp NeoPatient?
Numeric is replaced by -?-
INOP tone cmResp No Signal cmRespCan'tAnalyze cmRespPediPatient?
Numeric is replaced by -?-
INOP tone Respiration Default Settings Resp Resp Resp 4 IntelliVue CL Respiration Pod What to do The Respiration Pod has lost the SRR connection to the host. The temperature of the battery is too high. Take the Cableless Measurement Device away from the patient and contact service personnel. Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel. Unlicensed exchange device. Contact your service personnel. The patient monitor the Respiration Pod is assigned to is in neonatal mode. The INOP will remain active until the monitor is changed to adult mode. No active signal can be detected. Unable to analyze respiration and pulse signal The patient monitor the Respiration Pod is assigned to is in pediatric mode. The INOP will remain active until the monitor is changed to adult mode. These are the most important default settings of your IntelliVue CL Respiration Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in the Support Tool Configuration Editor. Respiration Settings Mode Repeat Time cmResp Pulse Dyn. Repetition Posture Activity Aging Time Color Factory Defaults Auto 15 min On On Enabled Off Off 10 min Yellow 109 4 IntelliVue CL Respiration Pod Integrated Battery Handling Battery Care The IntelliVue CL Respiration Pod has a built-in battery that is not exchangeable. Battery care begins when you receive a new pod and continues throughout the life of the pod. The table below lists battery care activities and when they should be performed. Activity Charge the battery When to perform Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. When not in use for an extended period of time. Store the device in a state of charge in the range of 40-50% and power off the device completely. Handling Precautions Lithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage. Handle with care. Do not expose the device to liquids. Do not attempt to disassemble the device. Do not put device in autoclave. Damaged devices should not be used anymore. WARNING Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. Do not incinerate the devices or expose them to temperatures above 60C (140F). they should be powered off for storage they should be stored in a cool place, ideally between 15C and 25C (60F and 77F) the state of charge should be between 40-50%
they should be recharged every six months If unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:
Storing in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20C (-4F) to 60C (140F). Do not store cableless devices in direct sunlight. NOTE Storing the devices at temperatures above 40C (104F) for extended periods of time could significantly reduce the battery's life expectancy. Storage 110 4 IntelliVue CL Respiration Pod Battery Lifetime Management The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. The batteries of the IntelliVue CL Respiration Pod cannot be exchanged, so the device itself must be replaced after 4 years or 400 complete charge-discharge cycles. Accessories You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available. WARNING Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. Philips approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. IntelliVue CL Respiration Pod Accessories Part Number 989803179541 Description Mobile CL Respiration Pod Attachment Contents 50 attachments 111 4 IntelliVue CL Respiration Pod Maintenance and Troubleshooting WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories You should perform a visual inspection before every use, and in accordance with your hospital's policy:
Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. WARNING If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philips-
qualified service professionals only. Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Troubleshooting If the status LED does not light up when you press a key, place the device onto a charger slot on the charging station. If you suspect a problem with an individual measurement device, read the Instructions for Use and double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to. If you suspect an intermittent, system-wide problem call your service personnel. 112 5 5Cableless Measurement Auxiliary Devices IntelliVue CL Transmitter and IntelliVue CL Hotspot IntelliVue CL Transmitter IntelliVue CL Hotspot The IntelliVue CL Transmitter and the IntelliVue CL Hotspot are auxiliary network devices that convert the SRR radio technology from the IntelliVue CL SpO2 Pod, the IntelliVue CL NBP Pod and the IntelliVue CL Respiration Pod into WLAN or LAN technology. This allows data from the measurement devices to be transmitted to a PC for use with IntelliVue GuardianSoftware. The IntelliVue CL Transmitter is a mobile device which can be worn by the patient or by an attending caregiver. It transmits vital signs data to IntelliVue GuardianSoftware while the patient is moving around. The display on the CL Transmitter shows only technical data that may be useful for troubleshooting system problems. The IntelliVue CL Hotspot serves as an access point in a fixed location, to provide communication to IntelliVue GuardianSoftware for any CL Pods currently in its transmission area. The CL Hotspots will normally be located in areas where mobile patients regularly pass by or spend time. When the patient comes into the transmission area, any available measurement results will be automatically communicated to GuardianSoftware. The IntelliVue CL Transmitter is battery-powered while the IntelliVue CL Hotspot is powered by an external power supply or PoE (Power over Ethernet). 113 5 Cableless Measurement Auxiliary Devices WARNING The IntelliVue CL Hotspot may not be used in the patient vicinity. Screen Layout The CL Transmitter and CL Hotspots have the same hardkeys and display as the CL SpO2 and NBP Pods. However, there is no user interaction required during normal operation. This is the standard screen of a CL Transmitter or CL Hotspot:
Screen of a CL Transmitter / CL Hotspot:
Equipment label 1 2 Number of GuardianSoftware Servers connected 3 Network status symbols (LAN and WLAN) 4 Connection status 5 Number of Cableless Measurement Devices connected 6 Battery gauge The network status symbols show one of the following states:
State off not connected LAN symbol
- (no symbol displayed) WLAN symbol
- (no symbol displayed) no IP address no Guardian server connected normally connected CL Transmitter Integrated Battery Handling Battery Care Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed. Activity Perform a visual inspection Charge the battery When to perform Before using the IntelliVue Cableless Measurement Device Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. When not in use for an extended period of time, or when the device is shipped. Store the device in a state of charge in the range of 40-50% and power off the device completely. 114 Handling Precautions 5 Cableless Measurement Auxiliary Devices Lithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage. Handle with care. Do not expose the device to liquids. Do not attempt to disassemble the device. Do not put device in autoclave. Damaged devices should not be used anymore. WARNING Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. Do not incinerate the devices or expose them to temperatures above 60C (140F). Storage they should be powered off for storage they should be stored in a cool place, ideally between 15C and 25C (60F and 77F) the state of charge should be between 40 and 50%
they should be recharged every six months If unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:
Storing in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20C (-4F) to 60C(140F). Do not store cableless devices in direct sunlight. NOTE Storing the devices at temperatures above 40C (104F) for extended periods of time could significantly reduce the battery's life expectancy. Battery Lifetime Management The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles. To see the date of manufacture and the number of charge-discharge cycles:
1 2 The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the hardkey to scroll through the list. The age of a lithium ion battery begins at the date of manufacture. Select the Battery Smartkey or Main Setup followed by Battery. Press the hardkey to view the battery details. 115 5 Cableless Measurement Auxiliary Devices Accessories You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available. WARNING Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. Philips approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. IntelliVue CL Transmitter Accessories Order Number 989803168881 989803168871 Description Mobile CL 20 Transmitter Cradle Kit Mobile CL Transmitter Battery Kit Contents 20 Single-Patient cradles and straps 1 Battery 1 disassembly tool 1 front housing 116 5 Cableless Measurement Auxiliary Devices IntelliVue CL Transmitter Base Station
(shown here with the transmitter inserted) The IntelliVue CL Transmitter Base Station is used with the IntelliVue CL Transmitter. When the patient is in their room, the Transmitter can be inserted into the Base Station where it is powered and recharged and also remains connected to the WLAN to communicate vital signs data. WARNING The IntelliVue CL Transmitter Base Station may not be used in the patient vicinity. Ensure that the CL Transmitter Base Station does not come into close contact with implanted pacemakers, to avoid magnetic interference affecting the mode of the pacemaker. Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel. CAUTION The CL Transmitter Base Station generates a magnetic field. Do not store magnetic media (such as identity cards or credit cards with magnetic strips or magnetic tapes/disks) near to the Base Station, as the data may be damaged. 117 5 Cableless Measurement Auxiliary Devices IntelliVue CL Charging Station This section contains some general information about charging IntelliVue Cableless Measurement Devices. For detailed information about the IntelliVue CL Charging Station, please see the separate IntelliVue CL Charging Station Instructions for Use. Charging IntelliVue Cableless Measurement Devices All IntelliVue Cableless Measurement Devices and Auxiliary Devices except the CL Hotspot are battery powered and need to be recharged using the IntelliVue CL Charging Station. The batteries are built in and can only be exchanged by trained service personnel, with the exception of the IntelliVue CL Respiration Pod, where the whole device needs to be exchanged. To charge a battery, place the device onto a charger slot on the charging station. The NBP Pod and Transmitter should always be placed on one of the slots in the upper row. The battery power indicators will supply information about the charge status. WARNING Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel. Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the charging station to fit an ungrounded AC mains socket. Do not use AC mains extension cords or multiple portable socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in enclosure leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of a system. Battery Power Indicators There are various indications which help you keep track of the battery power status:
LEDs on the charging station slots battery status information on the charging station's display, the NBP/SpO2 Pod's display and the Respiration Pod's LED INOP messages battery symbol on the patient monitor's screen (when assigned to a patient monitor) battery symbol in GuardianSoftware (when assigned to a patient in GuardianSoftware) The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery menu. 118 Maintenance and Troubleshooting 5 Cableless Measurement Auxiliary Devices WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories You should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:
1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them. 2 WARNING If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philips-
qualified service professionals only. Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Troubleshooting If a device will not switch on when you press a key, place it onto a charger slot on the charging station. If you suspect a problem with an individual measurement device, read the Instructions for Use and double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to. If you suspect an intermittent, system-wide problem call your service personnel. 119 5 Cableless Measurement Auxiliary Devices 120 6 6Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospitals Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to "Guideline for Disinfection and Sterilization in Healthcare Facilities" issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies that apply within your hospital, and country. General Points Keep your IntelliVue Cableless Measurement Devices and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, decontaminate it first. Observe the following general precautions:
Do not allow liquid to enter the case. Do not immerse any part of the equipment or any accessories in liquid if it is not explicitly allowed and Always dilute according to the manufacturers instructions or use lowest possible concentration. described in the respective accessory Instructions for Use. Do not pour liquid onto the charging station. Never use abrasive material (such as steel wool or silver polish). WARNING If you spill liquid on the charging station or accessories, or if any device or accessory is accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. Do not use flammable agents for disinfecting cableless measurement devices in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff. 121 6 Care and Cleaning Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices The following instructions apply to the IntelliVue CL SpO2 Pod, the IntelliVue CL Respiration Pod, the IntelliVue CL NBP Pod, the corresponding single patient Mobile CL Cradles and the auxiliary devices:
IntelliVue CL Charging Station, IntelliVue CL Transmitter, IntelliVue CL Transmitter Base Station and IntelliVue CL Hotspot. Clean with a lint-free cloth, moistened with warm water (40C/104F maximum) and soap, a diluted non-
caustic detergent, tenside, ammonia- or alcohol-based cleaning agent. Do not use strong solvents such as acetone or trichloroethylene. CAUTION Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result. Hospital policy: Disinfect the product as determined by your hospitals policy only using the cleaning agents specified below, to avoid long term damage to the cableless device. Drying devices: Do not use heat sources, such as ovens or hairdryers, to dry the devices. Do not put the devices in a microwave. No sterilizing: Do not put the devices in an autoclave, they are not sterilizable. Rinse the Pods in water, paying special attention to the contact area to remove all residues. Wipe them dry with a clean cloth and then leave them to dry completely. Do not allow any liquid to enter the charging station case and avoid pouring it on the charging station while cleaning. The wristbands used with the Mobile CL SpO2 Cradles are single-patient items and cannot be cleaned or disinfected. Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors. Recommended Disinfection Agents We recommend that you use one of the following disinfectants:
Product Name Isopropanol Sodium Hypochlorite, bleach Hydrogen Peroxide Product Type liquid liquid liquid Manufacturer
-
-
-
Dilution 80%
1%
3%
122 6 Care and Cleaning Dilution According to manufacturer's instructions Product Name Bacillol AF Dismozon plus Meliseptol Incidin Foam Oxivir Tb Cleaner Disinfectant Super Sani-Cloth Germicidal Disposable Wipes Sani-Cloth Plus Germicidal Disposable Wipes Mikrozid Sensitive Wipes Mikrozid PAA Wipes Descogen Liquid rfu Lysoformin Descosept PUR Product Type liquid, spray liquid liquid, spray liquid liquid, spray wipes Manufacturer BODE Chemie GmbH BODE Chemie GmbH B. Braun Melsungen AG Ecolab Inc. Diversey Inc. PDI Inc. wipes wipes wipes liquid liquid liquid PDI Inc. Schlke & Mayr GmbH Schlke & Mayr GmbH Antiseptica Dr. Hans-Joachim Molitor GmbH Lysoform Dr. Hans Rosemann GmbH Dr. Schumacher GmbH Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors and NBP cuffs. Disposing of the IntelliVue Cableless Measurement Devices WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the IntelliVue Cableless Measurement Devices appropriately before disposing of them in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste. You will find detailed disposal information on the following webpage:
www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpd The Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. For information in disposal of accessories, refer to the accessory Instructions for Use. 123 6 Care and Cleaning 124 7 7Specifications IntelliVue CL SpO2 Pod IntelliVue CL NBP Pod IntelliVue CL Respiration Pod IntelliVue CL Charging Station IntelliVue CL Transmitter IntelliVue CL Transmitter Base Station IntelliVue CL Hotspot The specifications in this section apply to the:
The IntelliVue Cableless Measurement Devices might not meet the performance specification listed in this chapter, if stored or operated outside the specified environmental conditions. WARNING The IntelliVue Cableless Measurement Devices are not intended for use in an MRI environment or in an oxygen-enriched environment (e.g. hyperbaric chambers). During MR imaging, remove all IntelliVue Cableless Measurement Devices and sensors from the patient. Induced currents could cause burns. Indications for Use IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring and recording of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients. The IntelliVue CL SpO2 Pod is also intended for local attended monitoring of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL SpO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room. The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. 125 7 Specifications IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters noninvasive blood pressure and pulse rate wirelessly. The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring and recording of, and to generate alarms for, systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients. The IntelliVue CL NBP Pod is also intended for local attended monitoring of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room. The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. IntelliVue CL Respiration Pod:
The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult and pediatric patients. The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device. The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm). The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor. WARNING Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated. Rx only: US Federal Law restricts these devices to sale by or on the order of a physician. 126 Compatible Medical Devices 7 Specifications IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2 or X2 IntelliVue Telemetry System Transceivers TRx4841A/TRx4851A and MX40 wearable patient monitors1 Avalon Fetal Monitors1 Clinical information management system: IntelliVue GuardianSoftware 1 not compatible with the CL Respiration Pod Compatible Medical Devices supporting local attended monitoring together with CL SpO2 and NBP Pods:
Symbols IntelliVue Patient Monitors MP5/MP5SC/MP5T These symbols can appear on the IntelliVue Cableless Measurement Devices. Symbols Caution is necessary when operating the device. Follow instructions for use. Operating instructions should be considered when operating the device. Protective earth Equipotential grounding Alternating current Error LED USB interface NBP identifier Always use separate collection for waste electrical and electronic equipment (WEEE) Indicates location of the date of manufacture and/or name and address of manufacturer Connector has special protection against electric shocks and is defibrillator proof Built-in wireless network (WLAN) Non-ionizing radiation symbol SpO2 identifier Indicates manufacturing date Indicates location of serial number Indicates location of catalog number Indicates location of service number 127 7 Specifications Symbols Followed by two alphanumeric characters, indicates ingress protection grade Do not reuse Resp identifier China RoHS LAN connection indicator for connection to a wired network Not made with natural rubber latex Mass in kilogram (kg) RCM compliance mark EAC mark CSA US mark FCC ID Federal Communications Commission: FCC ID xxxx CMIIT ID Chinese Radio marking: CMIIT ID
(China Ministry of Industry and Information Technology) CE marking accompanied by the Notified Body number 0123 IC-ID (Industry Canada ID) One IC-ID labeling for each built in radio: OBR, SRR Japanese Radio marking: Radio mark + [R]-symbol + ID Taiwan Radio Label (NCC Logo) + ID Korea radio mark: KC logo, KCC ID number, and Conformity assessment information 128 7 Specifications Manufacturer's Information You can write to Philips at this address Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 71034 Boeblingen Germany Australia Sponsor:
Philips Electronics Australia Ltd 65 Epping Road, North Ryde, NSW Australia 2113 Visit our website at: www.healthcare.philips.com. Copyright 2017. Koninklijke Philips N.V. All Rights Reserved. Regulatory and Safety Specifications General Conditions for Cableless Measurements The IntelliVue Cableless Measurements are compliant with IEC 60601-1 Ed. 3. However, they can still be used with IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2/X2, Avalon Fetal Monitors, IntelliVue Telemetry System Transceivers TRx4841A/TRx4851A, MX40 wearable patient monitors, that are compliant with IEC 60601-1 Ed. 2. IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod:
0123 IntelliVue CL Charging Station and CL Transmitter:
The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, and CL Transmitter comply with the Medical Device Directive 93/42/EEC. In addition, the IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station and CL Transmitter comply with:
IEC 60601-1:2005 + Cor.1:2006 + Cor.2:2007+ A1:2012; EN 60601-1:2006+ AC:2010+ A1:2013; ANSI/
AAMI ES60601-1:2005/(R)2012; CAN/CSA C22.2 No. 60601-1-14 The possibility of hazards arising from software errors was minimized in compliance with:
ISO 14971:2007; EN ISO 14971:2012, IEC 60601-1-4:1996 + A1:1999; EN 60601-1-4:1996 + A1:1999;
IEC 60601-1-6:2010 / EN 60601-1-6:2010; IEC 60601-1-8:2006+A1:2012 / EN 60601-1-
8:2007+AC:2010; IEC 60601-2-49:2011 / EN 60601-2-49:2001 (NBP Pod and SpO2 Pod only). Classification (according to IEC 60601-1):
IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod: Internally powered equipment, Type CF, Continuous Operation IntelliVue CL Transmitter: Internally powered equipment, Continuous Operation IntelliVue CL Charging Station: Class I equipment, Continuous Operation IntelliVue CL Transmitter Base Station and CL Hotspot:
129 7 Specifications The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the Low Voltage Directive 2014/
35/EC. In addition, these devices comply with:
IEC 60950-1:2005; EN 60950-1:2006+A11:2009 +A1:2010 +A12:2011 +A2:2013. EMC and Radio Regulatory Compliance FCC and Industry Canada Radio Compliance IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL Transmitter This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme la norme NMB-001 du Canada. IntelliVue CL Transmitter Base Station This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe B est conforme la norme NMB-003 du Canada. IntelliVue CL Hotspot This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe A est conforme la norme NMB-003 du Canada. These devices comply with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radiofrequency interference and void your authority to operate this equipment. Usage of license-exempt local area network (LE-LAN) in Canada:
IntelliVue CL Transmitter and CL Hotspot The maximum antenna gain permitted (for devices in the bands 5250-5350 MHz and 5470-5725 MHz) complies with the e.i.r.p. limits as stated in RSS-210. The maximum antenna gain permitted (for devices in the 5725-5825 MHz band) complies with the e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210. The device for the band 5150-5250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION High power radars are allocated as primary users (meaning they have priority) of the bands 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices. Japanese Radio Law and Japanese Telecommunications Business Law Compliance IntelliVue CL Respiration Pod and CL Hotspot 130 R&TTE Directive Compliance IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, and CL Charging Station 7 Specifications IntelliVue CL Transmitter, and CL Hotspot Philips Medizin Systeme Boeblingen GmbH hereby declares that these products are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio and Telecommunications Terminal Equipment Directive). The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL Transmitter, and CL Hotspot incorporate a SRR module, which is Class 1 radio equipment. The IntelliVue CL Transmitter and CL Hotspot incorporate additionally the IntelliVue 802.11 Adapter, which is Class 2 radio equipment. The products are intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA. Individual countries may apply restrictions on putting this device into service or placing on the market. To obtain a copy of the original Declaration of Conformity, please contact Philips at the address as stated in the Manufacturer's Information. WARNING The IntelliVue CL Charging Station is Class A professional equipment. This equipment is not intended for use in domestic establishments or connection to the public mains network. In domestic establishments or when connected to the public mains network, this equipment may cause radio interference or may disrupt the operation of nearby equipment. The IntelliVue CL Hotspot is a Class A product. In a domestic environment this product may cause radio interference, in which case the user may be required to take adequate measures. This equipment generates, uses and radiates radiofrequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. The device, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements. EMC Directive Compliance IntelliVue CL Transmitter Base Station and CL Hotspot The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the EMC Directive 2014/
30/EC. In addition these devices comply with:
ETSI EN 301 489-1:V1.9.2, ETSI EN 301 489-17:V2.2.1 CISPR 22:2008 / EN55022:2010/AC 2011 and CISPR 24:2010 / EN55024:2010 131 7 Specifications Radiofrequency Radiation Exposure Information IntelliVue CL Transmitter For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it can be used with any accessory that positions the front side of the device a minimum of 10 mm from the body. The accessory itself must not contain any metal parts. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. Nevertheless it is strongly recommended to operate the CL Transmitter with the rear side towards the body to achieve best possible radio performance. Safety and Performance Tests You must follow and apply any national regulations on the qualification of the testing personnel and suitable measuring and testing facilities. Required safety and performance tests, and what to do if the Cableless Measurements do not meet these specifications, are described in the IntelliVue Cableless Measurements Service Guide. Electromagnetic Compatibility (EMC) Take special precautions regarding electromagnetic compatibility (EMC) when using the IntelliVue Cableless Measurements. Operate the IntelliVue Cableless Measurements according to the EMC information provided in these Instructions for Use and in the IntelliVue Cableless Measurements Service Guide. Portable and mobile radiofrequency (RF) communications equipment can affect the IntelliVue Cableless Measurements. WARNING For paced patients: The radiated SRR power of the IntelliVue SpO2, NBP and Respiration Cableless Measurement Devices, the CL transmitter, and other sources of radiofrequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients. In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products. WARNING For paced patients: The radiated WLAN power of the IntelliVue CL Transmitter, and other sources of radiofrequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patients. In order to minimize the possibility of interference, position the IntelliVue CL Transmitter, when body worn, as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products. 132 7 Specifications Accessories Compliant with EMC Standards All IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod accessories comply, in combination with the IntelliVue Cableless Measurement Devices, with the requirements of IEC 60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2006 or IEC 60601-1-2:2007; EN 60601-1-2:2007. WARNING Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices. Electrosurgery Interference/Defibrillation The IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod including all accessories are suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator. Measurement accuracy may be temporarily decreased or measurement may be interrupted while performing electrosurgery or defibrillation. The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. This does not affect patient or equipment safety. Do not expose the equipment to X-ray or strong magnetic fields (MRI). IntelliVue CL SpO2 Pod Specifications Complies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011. Physical Specifications Size (W x H x D) Weight Robustness Ingress Protection 54 mm x 27 mm x 65 mm 5% (2.1 in x 1.1 in x 2.6 in 5%)
(without cradle and sensor) 82 g 10% (2.8 oz 10%) Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop IP34 according to IEC 60529 (protection against ingress of water when water drips, falls or splashes from any direction, and protection against contact with or ingress of objects larger than 2.5 mm) Environmental Specifications Operating Temperature Range Operating Humidity Range Operating Altitude Range Storage/Transportation Temperature Range Storage/Transportation Humidity Range 90% RH @ 60C (140F) 0 to 40C (32 to 104F) 95% RH @ 40C (104F)
-500 to 3000 m
-20 to 60C (-4 to 140F) Storage/Transportation Altitude Range no condensation
-500 to 4600 m Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, 133 7 Specifications only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Maximum with NBP INOP suppression on: 60 seconds. Performance Specifications SpO2 Measurement Range Accuracy The specified accuracy is the root-mean-square
(RMS) difference between the measured values and the reference values 0 to 100%
Mobile CL DSpO2-1A single patient sensor:
3% (70 to 100%) Mobile CL RSpO2-1A reusable sensor
(may not be available in all geographies):
3% (70 to 100%) 1%
70% to 100%
30 to 300 bpm 2% or 1 bpm, whichever is greater 1 bpm Resolution Pulse Oximeter Calibration Range Pulse Measurement Range Accuracy Resolution Sensors LED Power Dissipation Optical Output Power Wavelength Range Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed) For further information on accessory specifications, refer to the accessory Instructions for Use. Display Specifications Type Viewing Area Dot Size Resolution Backlight Sounds Temperature rise at sensor skin interface in compliance with ISO 9919 15 mW 500 to 1000 nm monochrome (4 gray scales), passive LCD (STN), positive/transflective 25.6 mm x 19.2 mm 0.2 mm x 0.2 mm 128 x 96 pixel white LED Hardkey operation tone Assignment tone Alarm tone Pulse tone with and without tone modulation Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Battery 134 7 Specifications Performance Specifications Runtime (fully charged battery) Charging Time Short Range Radio Specifications Type Technology Frequency band Modulation Bandwidth Effective radiated power (ERP) Electronic Article Surveillance (EAS) Real Time Clock Accuracy 1Approval pending Continuous measurement:
Typically 24 hours Minimum 12 hours in continuous mode Intermittent measurement:
Typically 60 hours with repetition interval of 2 minutes Typically 3 days with repetition interval of 5 minutes max 2.5 hours built in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 DSSS (O-QPSK) 5 MHz max. 0 dBm (1 mW) EAS tag inside the housing better than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Standby". Automatically synchronized with assigned host system. IntelliVue CL NBP Pod Specifications Complies with IEC 80601-2-30:2010 + A1:2013/EN 80601-2-30:2010. Measurement Validation Clinical investigation according ISO 81060-2:2013 with the auscultatory reference method the 5th Korotkoff sound (K5) was used in adult / adolescent subjects and the 4th Korotkoff sound
(K4) was used in pediatric subjects to determine the diastolic reference pressures the approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures. NOTE The effectiveness of this sphygmomanometer has been established in pregnant, including pre-eclamptic patients. Physical Specifications Size (W x H x D) Weight 66 mm x 138 mm x 31 mm 5% (2.6 in x 5.4 in x 1.2 in 5%)
(without cradle and cuff) 234 g 10% (8.3 oz 10%)
(without cradle and cuff) 135 7 Specifications Physical Specifications Robustness Ingress Protection Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop IP32 according to IEC 60529 (protected against ingress of water when the water is dripping vertically and the CL NBP Pod is tilted up to 15 and protected against contact with or ingress of objects larger than 2.5 mm) Environmental Specifications Operating Temperature Range Operating Humidity Range Operating Altitude Range Storage/Transportation Temperature Range Storage/Transportation Humidity Range 90% RH @ 60C (140F) (non-condensing) Storage/Transportation Altitude Range 0 to 40C (32 to 104F) 95% RH @ 40C (104F) (non-condensing)
-500 to 3000 m
-20 to 60C (-4 to 140F)
-500 to 4600 m The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. IntelliVue CL NBP Pod Performance Specifications Display Specifications Type Viewing Area Dot Size Resolution Backlight Sounds Battery Runtime (fully charged battery) Charging Time Short Range Radio Specifications Type Technology Frequency band 136 monochrome (4 gray scales), passive LCD (STN), positive/transflective 25.6 mm x 19.2 mm 0.2 mm x 0.2 mm 128 x 96 pixel white LED Hardkey operation tone Assignment tone NBP Announcement tone NBP done tone Alarm tone Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Minimum 12 hours @ 4 measurements per hour Typical 4 days @ 2 measurements per hour Typical 5 days @ 1 measurement every 2 hours Maximum 2.5 hours built in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 7 Specifications IntelliVue CL NBP Pod Performance Specifications Modulation Bandwidth Effective radiated power (ERP) Electronic Article Surveillance (EAS) Real Time Clock Accuracy DSSS (O-QPSK) 5 MHz max. 0 dBm (1 mW) EAS tag inside the housing Measurement Ranges Rated Range of Cuff Pressure Pressure Transducer Accuracy
(0 to 300 mmHg) Blood Pressure Measurement Accuracy Pulse Rate Measurement Range Pulse Rate Measurement Accuracy Measurement Time STAT Mode Cycle Time Initial Cuff Inflation Pressure Venipuncture Pressure Range Venipuncture Pressure Accuracy Cuff size detection 1Approval pending better than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Standby". Automatically synchronized with assigned host system. Adult:
Systolic: 30 to 270 mmHg (4.0 to 36.0 kPa) Mean: 20 to 255 mmHg (2.5 to 34.0 kPa) Diastolic: 10 to 245 mmHg (1.5 to 32.0 kPa) Pediatric:
Systolic: 30 to 180 mmHg (4.0 to 24.0 kPa) Mean: 20 to 160 mmHg (2.5 to 21.0 kPa) Diastolic: 10 to 150 mmHg (1.5 to 20.0 kPa) max. 300 mmHg (40.0 kPa) 3 mmHg @ 15 to 25C
(3 mmHg or 2% whichever is greater) @ 10 to 40C 8 mmHg standard deviation 5 mmHg mean error 40 to 300 bpm 40 - 100 bpm: 5 bpm 101 - 200 bpm: 5% of reading 201 - 300 bpm: 10% of reading
(average over NBP measurement cycle) Auto/manual/sequence mode:
Typical 40 seconds @ >60 bpm and normal adult cuff Maximum 180 seconds STAT and Accelerated Mode:
Typical 30 seconds @ >60 bpm and normal adult cuff Maximum 180 seconds 5 minutes Adult: 165 15 mmHg Pediatric: 130 15 mmHg Adult: 20 to 120 mmHg in steps of 5 mmHg Pediatric: 20 to 80 mmHg in steps of 5 mmHg 10 mmHg INOP, if neonatal cuff size is detected 137 7 Specifications IntelliVue CL Respiration Pod Specifications Complies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011. Physical Specifications Size (W x H x D) Weight Robustness Ingress Protection 45 mm x 14 mm x 65 mm 5% (1.7 in x 0.5 in x 2.5 in 5%)
(without accessories) 35 g 10% (1.2 oz 10%) Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop IP67 according to IEC 60529 Environmental Specifications Operating Temperature Range Operating Humidity Range Operating Altitude Range Storage/Transportation Temperature Range Storage/Transportation Humidity Range 90% RH @ 60C (140F), no condensation Storage/Transportation Altitude Range Storage/Transportation Ambient Pressure
(Altitude Range) 0 to 40C (32 to 104F) 95% RH @ 40C (104F), no condensation
-500 to 3000 m
-20 to 60C (-4 to 140F)
-500 to 4600 m 1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft) Performance Specifications Battery Runtime (fully charged battery) Charging Time Short Range Radio Specifications Type Technology Frequency band Modulation 138 Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Minimum 12 hours in frequent measurement mode with posture and activity detection Typically 18 hours in frequent measurement mode with posture and activity detection Minimum 1.5 days @ 4 measurements per hour without posture and activity detection Typical 3 days @ 4 measurements per hour without posture and activity detection Minimum 1 day @ 4 measurements per hour with posture and activity detection Typical 2 days @ 4 measurements per hour with posture and activity detection max 2.5 hours built in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 DSSS (O-QPSK) Performance Specifications Bandwidth Effective radiated power (ERP) Real Time Clock Accuracy Respiration Measurement Range Accuracy Resolution Pulse Measurement Range Accuracy Resolution Posture Information Activity Information 7 Specifications 5 MHz max. 2 dBm (1.6 mW) better than 5 seconds per day (typically) as long as device is in power state
"Device on". Automatically synchronized with assigned host system. 5 to 60 rpm 1 rpm 1 rpm Adult: 30 to 220 bpm For rapid, irregular heart rates: 30 to 110 bpm Pediatric: 30 to 220 bpm 3% or 1 bpm (whichever is greater) 1 bpm 14 patient postures (supine, prone, upright, reclined, forward, lying on left side, lying on right side, lying (unspecific), sitting, standing, rolling (in bed), walking, wheelchair (self), upside down) 10 levels from 1 (very low activity) to 10 (very high activity);
level 0: no signal 1Approval pending Attachment Specifications Size (W X H) Environmental Specifications Operating temperature range Storage / Transportation Temperature Range 196 mm x 64 mm (7.7 in x 2.5 in) 0 to 40C (32 to 104F) Storage: 12 to 35C (54 to 95F) Transportation: -20 to 60C (-4 to 140F) Storage / Transportation Humidity Range Storage: 18% RH to 78% RH Storage / Transportation Ambient Pressure (Altitude Range) Transportation: 90% RH @ 60C (140F); no condensation 1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft) 139 7 Specifications Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod When the CL Respiration Pod is used alone, without an assignment to a host, no physiological alarms will be generated. When the CL SpO2 Pod or CL NBP Pod are used for local attended monitoring, the following specifications apply:
Alarm Signal System Alarm Delay The system alarm delay is the processing time the system needs for any alarm to be indicated on the device, after the measurement has triggered the alarm. Delay for alarm availability on the network This is the time needed after alarm indication on the device until the alarm signal is available on the network, to the monitor or to other systems. Sound Pressure Range less than 4 seconds less than 5 seconds min. 0 dB(A) max. 30-65 dB(A) SpO2 Alarm Specifications SpO2 Desat Pulse Tachycardia Bradycardia Range Adult: 50 to 100%
Pedi: 30 to 100%
Adult: 50 to Low alarm limit Pedi: 30 to Low alarm limit 30 to 300 bpm Difference to high limit 0 to 50 bpm Clamping at 150 to 300 bpm Difference to low limit 0 to 50 bpm Clamping at 30 to 100 bpm Adjustment 1% steps 1% steps Adult:
1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi:
1 bpm steps (30 to 50 bpm) 5 bpm steps (50 to 300 bpm) 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps SpO2 Alarm Specifications (cont.) SpO2 high and low limit alarms Desat Pulse Tachycardia Bradycardia Standard Delay 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay 10 seconds + system alarm delay 10 seconds + system alarm delay 10 seconds + system alarm delay 140 7 Specifications Adjustment 10 to 30 mmHg: 2 mmHg (0.5 kPa)
>30 mmHg: 5 mmHg (1 kPa) NBP Alarm Specifications Systolic Diastolic Mean Range Adult: 30 to 270 mmHg (4 to 36 kPa) Pedi: 30 to 180 mmHg (4 to 24 kPa) Adult: 10 to 245 mmHg (1.5 to 32 kPa) Pedi: 10 to 150 mmHg (1.5 to 20 kPa) Adult: 20 to 255 mmHg (2.5 to 34 kPa) Pedi: 20 to 160 mmHg (2.5 to 21 kPa) When the Cableless Measurement Devices are assigned to a monitor or telemetry device, alarms may be announced at the host monitor (for the telemetry device, at the Information Center). See the respective Instructions for Use for detailed alarm specifications. Alarm delay times are as specified in the Instructions for Use of your patient monitor or IntelliVue Information Center plus 4 seconds. NOTE If the SRR connection between the Cableless Measurement Device and the patient monitor or telemetry device is interrupted, the patient monitor or telemetry device will issue an INOP within 5 seconds. Telemetry Device Battery Runtime Specifications Operating Mode ECG Only Telemetry Device with CL SpO2/NBP Pod connected Telemetry Device is host to CL SpO2/NBP Pod ECG/SpO2 (continuous) Telemetry Device with internal SpO2 running in continuous mode and CL SpO2/NBP Pod connected Telemetry Device is host to CL SpO2/NBP Pod IntelliVue CL Transmitter Specifications Battery Runtime 20 hours 8 hours Physical Specifications Size (W x H x D) Weight Robustness Ingress Protection 55 mm x 27 mm x 122 mm 5% (2.2 in x 1.0 in x 4.8 in 5%)
(without cradle) 154 g 10% (5.4 oz 10%)
(without cradle) Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop IP32 according to IEC 60529 (protected against ingress of water when the water is dripping vertically and the CL Transmitter is tilted up to 15 and protected against contact with or ingress of objects larger than 2.5 mm) 141 0 to 40C (32 to 104F) 0 to 35C (32 to 95F) when charging the battery with an active WLAN connection 95% RH @ 40C (104F) no condensation
-500 to 3000 m
-20 to 60C (-4 to 140F) Operating Altitude Range Storage / Transportation Temperature Range Storage / Transportation Humidity Range 90% RH @ 60C (140F)
(non-condensing)
-500 to 4600 m monochrome (4 grey scales), passive LCD (STN), positive/transflective 25.6 mm x 19.2 mm 0.2 mm x 0.2 mm 128 x 96 pixel white LED Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Typical 8 hours Maximum 2.5 hours EAS tag inside the housing built in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 DSSS (O-QPSK) 5 MHz max. 0 dBm (1 mW) Internal wireless adapter IEEE 802.11a/b/g/n 7 Specifications Environmental Specifications Operating Temperature Range Operating Humidity Range Storage / Transportation Altitude Range Performance Specifications Display Specifications Type Viewing Area Dot Size Resolution Backlight Battery Runtime (fully charged battery) Charging Time
(WLAN and SRR not active) Electronic Article Surveillance (EAS) Short Range Radio Specifications Type Technology Frequency Band Modulation Bandwidth Effective Radiated Power (ERP) WLAN Specifications Type Technology 142 7 Specifications USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz Europe: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHz Japan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 -
5.725 GHz China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 2.400 - 2.483 GHz: max. 18 dBm (63 mW) 5.150 - 5.725 GHz: max. 19 dBm (79 mW) 5.745 - 5.825 GHz: max. 14 dBm (25 mW) less than 5 seconds per day (typically) as long as device is in power state "Device on" or "Standby". Automatically synchronized with assigned patient monitor/
telemetry device. Performance Specifications Frequency Band Modulation Technique Effective Radiated Power (ERP) Realtime Clock Accuracy 1Approval pending IntelliVue CL Transmitter Base Station Specifications Physical Specifications Size (W x H x D) Weight Robustness Ingress Protection Environmental Specifications Operating Temperature Range Operating Humidity Range Operating Altitude Range 75 mm x 45 mm x 173 mm 5% (3.0 in x 1.8 in x 6.8 in 5%) 236 g 10% (8.3 oz 10%) Operating within specification during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1 IP21 according to IEC 60529 (protection against ingress of water when the water is dripping vertically) 0 to 40C (32 to 104F) 95% RH @ 40C (104F)
-500 to 3000 m
-500 to 2000 m when powered from external power supply 865222 #E90
-20 to 60C (-4 to 140F) Storage/Transportation Temperature Range Storage/Transportation Humidity Range 90% RH @ 60C (140F) Storage/Transportation Altitude Range no condensation
-500 to 4600 m 143 7 Specifications Performance Specifications Charging Interface (output) Power output (PoE powered) Power output (USB powered) Communication USB Interface Standard Power Input 5 V 10%
USB input voltage - 180 mV (@ 500 mA) USB 2.0 full speed USB 2.0 full speed Device Port 4.5 V - 5.5 V (8 W) power requirement for service and upgrade of connected Cableless Measurement Devices 2.5 W USB series Standard-B receptacle IEEE 802.3 100-Base-T, IEEE 802.3af (PoE Class 3) RJ45 (8 pin) Connector Network Standards Connector External AC/DC 5V requirements (connection to USB) Output voltage Power output Isolation Classification External AC/DC 48V requirements (connection to RJ45) Output Voltage Power output Compliancy Isolation Classification Connector IntelliVue CL Hotspot Specifications 5 V +/-5%
min. 8 W double according to IEC 60950-1 Class II Limited Power Source according to IEC 60950-1 48 V +/-10%
min. 8 W IEEE 802.3af (PoE Class 3) double according to IEC 60950-1 Class II Limited Power Source according to IEC 60950-1 RJ45 (Data-in), RJ45 (Data&Power Out) Physical Specifications Size (W x H x D) Weight Robustness Environmental Specifications Operating Temperature Range Operating Humidity Range 144 75 mm x 53 mm x 177 mm 5% (3.0 in x 2.1 in x 7.0 in 5%) 367 g 10% (12.9 oz 10%) Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1 0 to 40C (32 to 104F) 95%RH @ 40C (104F) no condensation 7 Specifications Environmental Specifications Operating Altitude Range Storage / Transportation Temperature Range Storage / Transportation Humidity Range 90% RH @ 60C (140F)
(non-condensing)
-500 to 4600 m
-500 to 3000 m
-500 to 2000 m when powered from external power supply 865222 #E90
-20 to 60C (-4 to 140F) Storage / Transportation Altitude Range Performance Specifications Display Specifications Type Viewing Area Dot Size Resolution Backlight Short Range Radio Specifications Type Technology Frequency Band Modulation Bandwidth Effective Radiated Power (ERP) WLAN Specifications Type Technology Frequency Band Modulation Technique Effective Radiated Power (ERP) monochrome (4 gray scales), passive LCD (STN), positive/transflective 25.6 mm x 19.2 mm 0.2 mm x 0.2 mm 128 x 96 pixel white LED built in interface with integrated antenna IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 DSSS (O-QPSK) 5 MHz max. 0 dBm (1 mW) Internal wireless adapter IEEE 802.11a/b/g/n USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz Europe: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHz Japan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 -
5.725 GHz China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 2.400 - 2.483 GHz: max. 18 dBm (63 mW) 5.150 - 5.725 GHz: max. 19 dBm (79 mW) 5.745 - 5.825 GHz: max. 14 dBm (25 mW) 145 7 Specifications Performance Specifications Realtime Clock Accuracy USB Interface Standard Power Input less than 5 seconds per day (typically) as long as device is in power state
"Standby" or "Device off". Automatically synchronized with assigned patient monitor/telemetry device. USB 2.0 full speed Device Port 4.5 V - 5.5 V (3 W) power requirement for service and upgrade of connected Cableless Measurement devices 2.5 W USB series Standard-B receptacle IEEE 802.3 100-Base-T, IEEE 802.3af (PoE Class 3) RJ45 (8 pin) Connector LAN Network Standards Connector External AC/DC 5V requirements (connection to USB) Output voltage Power output Isolation Classification External AC/DC 48V requirements (connection to RJ45) Output Voltage Power output Compliancy Isolation Classification Connector 5 V +/-5%
min. 3 W double according to IEC 60950-1 Class II Limited Power Source according to IEC 60950-1 48 V +/-10%
min. 3 W IEEE 802.3af (PoE Class 3) double according to IEC 60950-1 Class II Limited Power Source according to IEC 60950-1 RJ45 (Data-in), RJ45 (Data&Power Out) 1Approval pending 146 1Index A activity 107 alarms off symbol 32, 75 ambient light 31 assignment 22 at the measurement device 22 at the patient monitor 23 assignment mode 22 auto power off 17 automatic mode 74 automatic mode SpO2 31 averaging time 33 changing 33 B battery 50 care 50 lifetime management 51 power indicators 118 status menu 19 status on the cableless device 19 C care and cleaning 121 caution, definition 5 charging 118 cleaning and disinfecting 122 compatibility (NBP) 63 compatibility (SpO2) 21 configuration mode 17 connection status symbol 22 continuous mode SpO2 31 D date and time 19 default profile 18 demonstration mode 17 device compatibility (NBP) 63 device compatibility (SpO2) 21 disinfecting 122 disinfecting agents 122 disposing of the IntelliVue Cableless Measurement Device 123 E electromagnetic compatibility (EMC) 132 electrosurgery 69 electrosurgery interference/
defibrillation 133 elevated ambient temperatures 30 EMC 130 directive compliance 131 radio regulatory compliance 130 F FCC and industry canada radio compliance 130 fetal monitors (NBP) 66 fetal monitors (SpO2) 24 free device 18, 107 H hardkeys 15 I infection control 121 ingress protection (NBP Pod) 135 ingress protection (SpO2 Pod) 133 injected dyes 31 INOP 14, 56 layout 14 NBP 82 Resp 108 SpO2 40 tone 36 inspecting the equipment and accessories 53 IntelliVue CL hotspot specifications 144 IntelliVue CL NBP Pod 94 accessories 94 specifications 135 IntelliVue CL Respiration Pod 99 IntelliVue CL SpO2 Pod 52 accessories 52 specifications 133 IntelliVue CL Transmitter 116 accessories 116 specifications 141 IntelliVue CL transmitter and IntelliVue CL hotspot 113 IntelliVue CL transmitter base station 117 specifications 143 intended use 125 interference 22, 31 intravenous infusion 69 L local attended monitoring 43 loose sensor 30 low-activity screen 15 M main setup menu 17, 59 maintenance task and test schedule 53 manual mode SpO2 31 monitoring mode 17 MR imaging 125 N NBP 94 accessories 94 default settings 91 numerics 75 specifications 135 new patient 18 adding 18 no host monitoring 22, 25, 64, 67 O operating modes 17 oscillometric NBP measurement 69 oxygen saturation 28 P patient category 18 patient demographics 18 patient menu 18 patient movement 31 perfusion indicator 28, 31 perfusion numeric 33 pleth waveform 28 posture 107 posture detection 107 profiles 18 pulsatile flow 31 pulse oximetry 28 pulse rate 28 pulse rate numeric 32, 75 147 timestamp 75 timestamp SpO2 32 transceiver 26 transmitter base station specifications 143 troubleshooting 53 U use models 20 V venipuncture 76 venous pulsation 30 visual inspection 53 W warning 5 R R&TTE directive compliance 131 radiofrequency radiation exposure information 132 removing a patient from the device 18 removing the pod from the cradle 30 repetition time 74 respiration measurement 104 Respiration sensor 104 S safety and performance tests 132 safety specifications 129 screen layout 14 sensor (Resp) 105 applying 105 sensor (SpO2) 30 applying 30 sequence mode 75 service mode 17 setup sequence 75 short range radio 22 short range radio (SRR) 10 signal quality indicator 32 skin damage 69, 105 smartkeys 15 SpO2 52 accessories 52 default settings 49 numerics 32 sensors 28 signal quality indicator 32 specifications 133 SpO2 accessories 52 SpO2 numerics 32 SpO2 Sensors 29 Connecting 29 SpO2 specifications 133 standby mode 60 starting and stopping measurements
(NBP) 74 suspicious SpO2 reading 33 symbols 127 T technical alarms (INOPs, NBP) 82 technical alarms (INOPs, Resp) 108 technical alarms (INOPs, SpO2)) 40 telemetry device 20 telemetry device battery runtime specifications 141 test schedule 53 148 Part Number 453564657401 Published in Germany 02/2017
*453564657401*
1 2 | user manual mp2 english | Users Manual | 2.73 MiB | December 06 2017 |
Instructions for Use IntelliVue Patient Monitor MP2 Release L with Software Revision L.xx.xx Patient Monitoring 1 Basic Operation Safety Information Security Information Introducing the IntelliVue MP2 Controls, Indicators and Connectors Extending Measurements Operating and Navigating Operating Modes Understanding Screens Using the XDS Remote Display Using the Visitor Screen Understanding Profiles Understanding Settings Changing Measurement Settings Switching a Measurement On and Off Adjusting a Measurement Wave Using Labels Using IntelliVue Cableless Measurements Changing Monitor Settings Checking Your Monitor Revision Getting Started Disconnecting from AC Mains Power Monitoring After a Power Failure Networked Monitoring Capturing Alarm Reports and Printing 2 What's New?
What's New in Release L What's New in Release K.2 What's New in Release J.0 What's New in Release H.0 What's New in Release G.0?
What's New in Release F.0?
3 Alarms Visual Alarm Indicators Audible Alarm Indicators Acknowledging Alarms Pausing or Switching Off Alarms Alarm Limits 1Table of Contents 11 12 13 15 15 17 22 27 29 29 30 30 31 32 32 32 33 35 37 37 37 39 39 40 40 41 41 42 42 44 44 45 47 48 49 51 51 54 3 Reviewing Alarms Latching Alarms Testing Alarms Alarm Behavior at Power On Alarm Recordings 4 Patient Alarms and INOPs Patient Alarm Messages Technical Alarm Messages (INOPs) 5 Managing Patients and Equipment Patient Concepts Equipment Concepts Managing Patients Transferring Patients Managing Equipment Information Center Compatibility 6 ECG, Arrhythmia, ST and QT Monitoring Skin Preparation for Electrode Placement Connecting ECG Cables Selecting the Primary and Secondary ECG Leads Checking Paced Mode Understanding the ECG Display Monitoring Paced Patients Changing the Size of the ECG Wave Changing the Volume of the QRS Tone Changing the ECG Filter Settings Choosing EASI or Standard Lead Placement Selecting Positions of Va and Vb Chest Leads (for 6-lead placement) About ECG Leads ECG Lead Fallback ECG Lead Placements Capture 12-Lead EASI ECG Lead Placement ECG and Arrhythmia Alarm Overview Using ECG Alarms ECG Safety Information About Arrhythmia Monitoring Switching Arrhythmia Analysis On and Off Choosing an ECG Lead for Arrhythmia Monitoring Understanding the Arrhythmia Display Arrhythmia Relearning Arrhythmia Alarms About ST Monitoring Switching ST or STE On and Off 4 57 58 59 59 60 61 61 68 85 85 85 86 91 95 103 105 105 105 106 106 107 108 109 110 110 110 111 111 112 112 118 122 123 125 127 129 129 129 131 134 135 139 140 Understanding the ST Display and Windows Updating ST Baseline Snippets About the ST Measurement Points ST Alarms STE Alarms Viewing ST Maps About QT/QTc Interval Monitoring QT Alarms Switching QT Monitoring On and Off 7 Monitoring Pulse Rate Entering the Setup Pulse Menu System Pulse Source Switching Pulse On and Off Using Pulse Alarms 8 Monitoring Respiration Rate (Resp) Lead Placement for Monitoring Resp Understanding the Resp Display Changing Resp Detection Modes Changing the Size of the Respiration Wave Changing the Speed of the Respiration Wave Using Resp Alarms Changing the Apnea Alarm Delay Resp Safety Information 9 Monitoring with the CL Respiration Pod (cmResp) Measurement Principles Measurement Modes Making Measurements Understanding the Numerics Setting the Measurement Mode Setting the Repeat Time Switching Posture and Activity Level On and Off 10 Monitoring SpO2 SpO2 Sensors Applying the Sensor Connecting SpO2 Cables Measuring SpO2 Understanding the SpO2 Numerics Assessing a Suspicious SpO2 Reading Changing the Averaging Time Setting the Measurement Mode Understanding SpO2 Alarms Pleth Wave 141 143 143 146 147 147 152 155 156 157 157 157 158 158 161 161 162 163 164 164 164 164 164 167 167 168 168 168 169 169 170 171 171 172 173 173 174 175 175 176 176 181 5 Perfusion Numeric Perfusion Change Indicator Setting SpO2/Pleth as Pulse Source Setting Up Tone Modulation Setting the QRS Volume 11 Monitoring NBP Introducing the Oscillometric NBP Measurement Preparing to Measure NBP Starting and Stopping Measurements Enabling Automatic Mode and Setting Repetition Time Enabling Sequence Mode and Setting Up The Sequence Choosing the NBP Alarm Source Switching Pulse from NBP On/Off Assisting Venous Puncture Calibrating NBP 12 Monitoring Temperature Making a Temp Measurement Calculating Temp Difference 13 Monitoring Invasive Pressure Setting up the Pressure Measurement Overview of Calibration Procedures Zeroing the Pressure Transducer Calibrating Reusable Transducers Adjusting the Calibration Factor Displaying a Mean Pressure Value Only Changing the Pressure Wave Scale Optimizing the Waveform Non-Physiological Artifact Suppression Choosing the Pressure Alarm Source Calculating Cerebral Perfusion Pressure 14 Monitoring Carbon Dioxide Measurement Principles Measuring CO2 using the CO2 Option or M3014A Measuring Microstream CO2 using M3015A/B Setting up all CO2 Measurements Understanding the IPI Numeric 15 Using a Telemetry Device and a Monitor How Can You Combine Devices?
Unpairing the Monitor and Telemetry Device Temporarily Stopping the Short Range Radio Connection 6 181 181 181 182 182 183 183 185 187 188 189 189 190 190 190 191 191 192 193 193 195 195 197 199 199 199 199 199 200 201 203 204 205 209 210 213 215 215 218 218 16 Enhancing Telemetry Monitoring with the Monitor Monitor and Telemetry Transceiver Requirements 17 Trends Viewing Trends Setting Up Trends Documenting Trends Trends Databases Screen Trends 18 Recording Starting and Stopping Recordings Overview of Recording Types Creating and Changing Recordings Templates Recorder Status Messages 19 Printing Patient Reports Starting Report Printouts Stopping Reports Printouts Setting Up Reports Setting Up Individual Print Jobs Checking Printer Settings Printing a Test Report Switching Printers On or Off for Reports Dashed Lines on Reports Unavailable Printer: Re-routing Reports Checking Report Status and Printing Manually Printer Status Messages Sample Report Printouts 20 Care and Cleaning General Points Cleaning the Monitor Disinfecting the Equipment Sterilizing the Equipment Cleaning, Sterilizing and Disinfecting Monitoring Accessories Cleaning Batteries and the Battery Compartment 21 Using Batteries Battery Power Indicators Checking Battery Charge When Battery Lifetime is Expired Replacing a Battery Optimizing Battery Performance Battery Safety Information 219 219 221 221 224 227 227 228 231 231 232 232 233 235 235 236 236 238 238 239 239 239 239 240 241 242 245 245 246 246 247 247 247 249 250 252 252 253 254 256 7 22 Maintenance and Troubleshooting Inspecting the Equipment and Accessories Inspecting the Cables and Cords Maintenance Task and Test Schedule Troubleshooting Disposing of the Monitor Disposing of Empty Calibration Gas Cylinders 23 Accessories ECG/Resp Accessories NBP Accessories Invasive Pressure Accessories SpO2 Accessories Temperature Accessories Mainstream CO2 Accessories Sidestream CO2 Accessories Microstream CO2 Accessories Battery Accessories 24 Specifications Indications for Use Use Environment Restricted Availability Manufacturer's Information Symbols Installation Safety Information Monitor Mounting Precautions Altitude Setting Monitor Safety Specifications EMC and Radio Regulatory Compliance Out-Of-Hospital Transport - Standards Compliance Physical Specifications Environmental Specifications Monitor Performance Specifications Monitor Interface Specifications 865297 Battery Extension Specifications M4607A Battery Specifications M4605A Battery Specifications Measurement Specifications Safety and Performance Tests 25 Default Settings Appendix Alarm and Measurement Default Settings Alarm Default Settings ECG, Arrhythmia, ST and QT Default Settings Pulse Default Settings 8 257 257 258 258 258 259 259 261 261 264 270 273 278 279 279 280 281 283 283 283 284 284 285 287 287 288 288 288 290 291 292 293 294 296 296 297 298 312 317 317 317 318 321 Respiration Default Settings SpO2 Default Settings NBP Default Settings Temperature Default Settings Invasive Pressure Default Settings CO2 Default Settings Index 321 322 322 323 323 325 327 9 10 1Basic Operation 1 These Instructions for Use are for clinical professionals using the IntelliVue MP2 (M8102A) patient monitor. This basic operation section gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching a measurement on and off, setting up and adjusting wave speeds, working with profiles). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here. This guide describes all features and options. Your monitor may not have all of them; they are not all available in all geographies. Your monitor is highly configurable. What you see on the screen, how the menus appear and so forth, depends on the way it has been tailored for your hospital and may not be exactly as shown here. This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Contact your local sales representative and/or Philips Customer Support for details. In this guide:
A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Monitor refers to the entire patient monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor's display, such as measurements, alarms, patient data and so forth. For installation, repair, testing and troubleshooting instructions, refer to the Service Guide for your monitor model. Rx only: U.S. Federal Law restricts this device to sale by or on the order of a physician. 11 1 Basic Operation Safety Information The following warnings apply to the monitors in general. Warnings that apply to specific measurements or procedures can be found in the corresponding chapters. Electrical Hazards and Interference WARNING Grounding: To avoid the risk of electric shock, the monitor must be grounded during operation. If a three-wire receptacle is not available, consult the hospital electrician. Never use a three-wire to two-
wire adapter. Electrical shock hazard: Do not open the monitor or measurement device. Contact with exposed electrical components may cause electrical shock. Refer servicing to qualified service personnel. Leakage currents: If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in:
ANSI/AAMI ES60601-1 CAN/CSA C22.2 No. 60601-1-08 Consult your service personnel. Radio frequency interference: The monitor generates, uses and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. IEC/EN 60601-1 Use Environment WARNING Explosion Hazard: Do not use in the presence of flammable anesthetics or gases, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide or in the presence of other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. Use of the devices in such environments may present an explosion hazard. Positioning Equipment: The monitor should not be used next to or stacked with other equipment. If you must stack the monitor, check that normal operation is possible in the necessary configuration before you start monitoring patients. Environmental Specifications: The performance specifications for the monitors, measurements and accessories apply only for use within the temperature, humidity and altitude ranges specified in the environmental specifications in the Instructions for Use. Liquid Ingress: If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. Prohibited Environments: The monitors are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers). 12 Alarms 1 Basic Operation WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Be aware that the monitors in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Accessories WARNING Philips' approval: Use only Philips-approved accessories. Using other accessories may compromise device functionality and system performance and cause a potential hazard. Reuse: Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential cross-infection hazard. Electromagnetic compatibility: Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Damage: Do not use a damaged sensor or one with exposed electrical contacts. Do not use damaged accessories. Do not use accessories where the packaging has been damaged or opened. Cables and tubing: Always position cables and tubing carefully to avoid entanglement or potential strangulation. MR Imaging: During MR imaging, remove all transducers, sensors and cables from the patient. Induced currents could cause burns. Use-by date: Do not use accessories where the use-by date has been exceeded. Electrosurgery: Do not use antistatic or conductive endotracheal tubes as they may cause burns in case of electrosurgery. Security Information Protecting Personal Information Protecting personal health information is a primary component of a security strategy. Each facility using the monitors must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facilitys policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats. 13 1 Basic Operation As per its intended use, the patient monitor operates in the patient vicinity and contains personal and sensitive patient data. It also includes controls to allow you to adapt the monitor to the patient's care model. To ensure the patient's safety and protect their personal health information you need a security concept that includes:
Physical security access measures - access to the monitor must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access. Operational security measures - for example, ensuring that patients are discharged after monitoring in order to remove their data from the monitor. Procedural security measures - for example, assigning only staff with a specific role the right to use the monitors. In addition, any security concept must consider the requirements of local country laws and regulations. Always consider data security aspects of the network topology and configuration when connecting patient monitors to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred. When a monitor is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the monitor by ending monitoring for the last patient (see Ending Monitoring for a Patient on page 89). NOTE Log files generated by the monitors and measurement modules are used for system troubleshooting and do not contain protected health data. About HIPAA Rules If applicable, your facilitys security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit:
http://www.hhs.gov/ocr/privacy/. About the EU Directives If applicable, your facilitys security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional, more stringent standards put forward by any individual EU countries; that is, Germany, France, and so on. Philips Product Security Policy Statement Additional security and privacy information can be found on the Philips product security web site at:
http://www.healthcare.philips.com/main/support/equipment-performance/product-security/
index.wpd 14 1 Basic Operation Manufacturer Disclosure Statement for Medical Device Security MDS2 You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at:
http://www.healthcare.philips.com/main/support/equipment-performance/product-security/
index.wpd Introducing the IntelliVue MP2 The Philips IntelliVue MP2 monitor provides a comprehensive set of basic physiological measurements: ECG (including ST analysis and optional 10-lead ECG), NBP, SpO2, and optionally invasive blood pressure, temperature and CO2. Through networking it provides information integration, documentation and information access. The MP2 can be used with adult, pediatric and neonatal patients in a hospital environment and during patient transport both inside and outside hospitals. The monitor stores data in trend databases. You can see tabular trends (vital signs) and document them on a central printer. You can view measurement trend graphs, including horizon trends, to help you identify changes in the patient's physiological condition. The monitor can be powered by a rechargeable battery, or from AC mains using the external power supply (M8023A). For battery charging, care and status information, refer to the chapter Using Batteries on page 249. Controls, Indicators and Connectors MP2 Overview 1 On/Standby Switch 2 3 Power and battery indicators (see MP2 Controls and Indicators on page 16) 3.5-inch TFT LCD touchscreen QVGA display 15 1 Basic Operation 4 Alarm lamps (see MP2 Controls and Indicators on page 16) 5 Built-in carrying handle 6 Battery eject button 7 Keys (see MP2 Controls and Indicators on page 16) 8 Measurement connectors (see MP2 Patient Connectors, Right Side on page 17) 9 Battery MP2 Controls and Indicators 1 On/Standby switch 2 On/Standby LED. Green when monitor is on. Red indicates an error. 3 Battery status LED. Yellow when charging. Flashing red when battery is empty, or a battery malfunction is detected. 4 External power LED. Green when monitor is powered from an external power source. 5 Alarms off indicator. When alarms are suspended, the lamp is red, and the Alarms Off message appears on the screen. 6 Active INOP alarm lamp in light blue. Stays lit until active INOP is acknowledged. 7 Active alarm lamp. Red or yellow, depending on alarm level. Stays lit until active alarm is 8 9 Alarms key: turns alarms On/Off, or pauses them 10 SmartKeys key: brings up SmartKeys on the screen 11 Main Screen key: closes all open menus/windows and returns to the main screen, or selects acknowledged. Silence key current screen. 16 MP2 Patient Connectors, Right Side English version International version 1 Basic Operation Pressure (option) 1 2 Temperature (option) 3 Noninvasive blood pressure 4 5 ECG sync pulse output (See SpO2 Monitor Performance Specifications on page 293 for specifications) MP2 Left Side 6 ECG/Respiration 7 CO2 (option) 1 Loudspeaker (do not cover with labels or stickers as this will reduce the loudspeaker volume). 2 MSL Connector. Connects to the external power supply via the MSL cable for AC mains operation, battery charging, and communication with a network. Extending Measurements Your monitor is compatible with Philips measurement extensions for use with other IntelliVue patient monitoring devices. These allow you to add specific measurements to those already integrated into your monitor. These measurement extensions are referred to as MMS extensions. During patient transport, the monitor with the connected MMS extension can be powered by the Battery Extension
(see Using the Battery Extension on page 20). 17 1 Basic Operation MMS Extension M3014A attached to the MP2 The MMS extensions connect to the monitor and use the monitor's settings. Trend data and measurement settings from the measurements in the extensions are stored in the monitor. WARNING Measurements from an MMS extension are only available when the extension is connected to the monitor, and the monitor is running on external power. This is the case when the monitor is running on AC mains via the external power supply (M8023A) or is attached to the Battery Extension (865297). Measurements from an MMS extension connected to the monitor are not available when the monitor is running on its own battery power. Any measurements on an MMS extension that conflict with those in the monitor cannot be used. For example, only one CO2 measurement is supported. The Cardiac Output and Continuous Cardiac Output option of the MMS extensions is not available for the MP2 monitor. To separate an extension from the monitor, press the release lever and push the extension forward. 18 M3014A, M3015A, and M3015B Capnography MMS Extensions The optional M3014A Capnography extension adds mainstream capnography or sidestream capnography, and optionally one pressure plus either a pressure or a temperature to the monitor. M3014A 1 Basic Operation Pressure connectors (red) 1 2 Temperature connector (brown) 3 Mainstream/sidestream connector CO2 4 Cardiac Output connector The optional M3015A Microstream CO2 extension adds microstream capnography and optionally either pressure or temperature to the monitor. The optional M3015B Microstream CO2 extension adds microstream capnography, two pressures and a temperature to the monitor. M3015A M3015B Pressure connectors (red) - M3015A optional 1 2 Temperature connector (brown) - M3015A optional 3 Gas sample outlet 4 Microstream connector CO2 and Inlet 19 1 Basic Operation M3012A Hemodynamic MMS Extension 1 Cardiac Output (orange; optional) 2 Connection to monitor 3 4 Temperature connectors (brown) Pressure connectors (red) When attached to the MP2 connected to the external power supply, the optional M3012A Hemodynamic extension adds temperature, pressure, and an additional pressure or a temperature to the monitor. Using the Battery Extension To provide enough power for the use of an MMS Extension during transport, you can use the Battery Extension (865297). The Battery Extension provides additional battery power for situations when no mains power is available and can typically power the monitor with MMS Extension for at least 6 hours. When running from the Battery Extension with no mains supply available, the monitor will not charge its internal battery. Connecting the Battery Extension To connect to the Battery Extension, place the monitor with MMS Extension onto the Battery Extension, and then slide it across so that the connection is made and it is firmly seated. 20 1 Basic Operation To remove the monitor with MMS Extension, press the release lever and push the monitor across to release the connection. LED Indicators The Battery Extension has two LED indicators. The power LED lights green when the Battery Extension is connected to external power. The battery charge led gives battery status information. External power available LED indication green yellow red flashing (short on phase) red flashing (long on phase) off Status Battery fully charged. Battery charging. Battery maintenance required. Battery Extension malfunction. No battery inserted in the Battery Extension. External power not available LED indication yellow flashing (short on phase) red flashing (short on-phase) red flashing (long on-phase) Status Battery Extension is charging the monitor battery (monitor is switched off). If the monitor is running, this indicates very low battery charge
(<10 minutes running time left). If the monitor is not running, this indicates that battery maintenance is required. Battery Extension cannot provide power to the monitor. Either the Battery Extension needs charging, or it has a malfunction. 21 1 Basic Operation IntelliVue Cableless Measurements The IntelliVue Cableless Measurements (IntelliVue CL SpO2 Pod CL NBP Pod and CL Respiration Pod) are patient-worn measurement devices which communicate measurement values to the monitor using a wireless short range radio (SRR) interface. The CL SpO2 Pod and CL NBP also provide the measurement values on their built-in screen. Measurement Device Main Parts and Keys The SpO2 Pod and the NBP Pod have an LCD display and three keys for basic operation e.g. to assign the device to a patient:
Integrated monochrome LCD display 1 2 Hardkeys 3 Measurement identifier The Respiration Pod has one multi-color LED for status display and one hardkey for basic operation, e.g. to start a measurement:
1 Multi-color LED 2 Hardkey 3 Indication for built-in RFID tag Operating and Navigating The principle method of operating your monitor is via the touchscreen. Almost every element on the screen is interactive. Screen elements include measurement numerics, information fields, alarms fields, waveforms and menus. The typical operator's position is in front of the monitor. There are also four keys to the right of the screen (see also MP2 Controls and Indicators on page 16). These let you:
Key with symbol
(international) Text replaces symbol (English versions only) Silence alarms: the Silence key acknowledges all active alarms by switching off audible alarm indicators and lamps. Switch alarms on or off, or pause alarms. 22 These let you:
Call up SmartKeys on the screen (see below). 1 Basic Operation Key with symbol
(international) Text replaces symbol (English versions only) Close all open menus/windows and return to the main screen. If you are already in the main screen (no additional menus/windows are open), then pressing this key opens the Change Screen menu, where you can choose from a number of pre-configured screens. To temporarily disable the touchscreen operation, press and hold this key for 2 seconds. Press the key again to re-
enable the touchscreen operation. A typical main screen looks like this:
MP2 Screen Elements Description Item 1 Alarm volume off indicator Comments is displayed when the alarm volume is set to zero
(0). 23 1 Basic Operation MP2 Screen Elements Item Description Patient name / alarm 2 message field Comments Patient name can be covered by alarm messages or alarms On/Off/Paused message. If red and yellow alarms are active at the same time, they rotate in the alarm field. Patient category and bed label
/ INOP message field Patient category and bed label can be covered by INOP messages. If there are multiple red/yellow/cyan INOPs active at the same time, they rotate in the INOP field. Documented in Information Center Instructions for Use. Network connection indicator Measurement label Touch the measurement to enter the measurement setup menu. Displayed below the HR label. Paced status Measurement numeric/values Touch the numeric to enter the measurement setup menu. Measurement wave Status line Touch the wave to enter the measurement setup menu. Shows information and messages prompting you for action. Measurement Selection key Opens the Measurement Selection window which shows all measurements and where they are physically located. From here you can also enter the measurement setups. Gives information about remaining battery charge, estimated operating time, maintenance requirements and malfunctions. See the chapter Using Batteries on page 249. Battery status indicator 3 4 5 6 7 8 9 10 11 Using the Touchscreen Touch a screen element to get to the actions linked to that element. For example, touch a measurement numeric and the setup menu for that measurement opens. Touch a wave to enter the setup menu for that wave. Measurement Setup Menus Each measurement has a setup menu where you can change settings. Typically, the setup menu window covers the whole screen, except the INOP and alarm message fields, which are always displayed at the top. The following picture is an example, and may not show exactly what you see on the screen. All measurement setup windows are similar and share the same basic layout. 24 Touch the measurement numeric on the screen to enter the setup menu. 1 Basic Operation Key to measurement setup menu:
Item Description 1 2 3 4 5 INOP and alarm message field Wave/numerics window Status/prompt message Next page arrows Measurement menu keys Comment These are always displayed at the top of the screen. The main measurement numeric and wave (if applicable) are shown in this window so that you do not lose sight of the current measurement while making changes in the menu. Status/prompt messages related to the measurement menu are displayed below the wave/numerics. General status/prompt messages on the main screen are covered by the measurement setup menu. The menu may have more than one page, as shown here. Move to another page by touching these arrows. Each button has two lines of text. To perform an operation on a measurement, press one of the keys. Some keys lead directly to a task. For example, pressing the Start/ Stop key for noninvasive blood pressure starts a measurement. Other keys open a pop-up window, which can have more than one page, from which you make a selection. Again, using noninvasive blood pressure as an example, pressing the Repeat Time key for setting the repetition time opens a pop-up window from which you pick a time, scrolling if necessary. Main Setup Menu There is usually more than one way to enter a setup menu for a measurement, to change a setting or to execute a task. Some routes are more direct than others. You can use whichever method you find most convenient. Which routes are available to you, however, can vary depending on your monitors configuration. For this reason, this book generally describes entry to a measurements setup menu via the Main Setup menu, as this route is always available and is not subject to configuration dependencies. You can get to all setup windows from the Main Setup menu. You enter the Main Setup menu by pressing the SmartKeys key, then selecting the Main Setup SmartKey. 25 1 Basic Operation SmartKeys A SmartKey is a configurable graphical key on the screen allowing fast access to frequently used functions. Press the SmartKeys hard key to call up a set of SmartKeys on the screen. Although the selection of SmartKeys available on your monitor depends on the monitor configuration and on the options purchased, the SmartKeys window generally looks like this:
1 Scroll to see more SmartKeys enter Main Setup menu - you can get to all setup windows using this key enter profile menu, or revert to default profile previous Screen enter standby mode - suspends patient monitoring. All waves and numerics disappear from the display. All settings and patient data information are retained. change Screen, or revert to default screen quick admit a patient enter patient identification menu to admit/discharge/transfer end case to discharge a patient lock touchscreen operation set alarm limits change alarm volume change QRS volume review beat labels (annotate arrhythmia wave)
- start/stop manual NBP measurement
- start auto series
- stop current automatic measurement within series change screen brightness (not for independent displays) change amplitude (size) of ECG wave re-learn arrhythmia start NBP STAT measurement 26 1 Basic Operation stop automatic or STAT NBP measurement and measurement series start veni puncture (inflate cuff to subdiastolic pressure) start NBP measurement and measurement series stop current NBP measurement set the NBP repeat time access patient reports switch CO2 pump off new lead setup zero invasive pressure transducer set standard or EASI lead placement review vital signs trend review graph trend unpair equipment and continue central monitoring with the monitor start 12-Lead Capture (only available if Information Center is connected) unpair equipment and continue central monitoring with the telemetry device access ST Map application select measurement device start an SpO2 measurement access NBP mode selection and setup, with direct start/stop function open the Equipment window Pop-Up Keys Pop-up keys are task-related graphical keys that appear automatically on the monitor screen when required. For example, the Confirm pop-up key appears only when you need to confirm a change. Using the On-Screen Keyboard Use this as you would a conventional keyboard. Enter the information by selecting one character after another. Use the Shift and capital Lock keys to access uppercase letters. Use the Back key to delete single characters, or use the Clr key to delete entire entries. Select Enter to confirm what you have entered and close the on-screen keyboard. Operating Modes When you switch the monitor on, it starts up in monitoring mode. To change to a different mode:
1 2 Select the Main Setup menu. Select Operating Modes and choose the mode you require. 27 1 Basic Operation Your monitor has four operating modes. Some are passcode protected. Monitoring Mode: This is the normal, every day working mode that you use for monitoring patients. You can change elements such as alarm limits, patient category and so forth. When you discharge the patient, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options or the altitude setting, that are visible but grayed out so that you can neither select nor change them. These are for your information and can be changed only in Configuration Mode. Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring. In Demonstration Mode, all stored trend information is deleted from the monitors memory. Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on, the number of waves you see and so forth. Service Mode: Passcode protected, this is for trained service personnel. When the monitor is in Demonstration Mode, Configuration Mode, or Service Mode, this is indicated by a box with the mode name in the center of the Screen and a symbol in the bottom right-hand corner. Select the mode box in the center of the screen to change to a different mode. Standby Mode Standby mode can be used when you want to temporarily interrupt monitoring. To enter Standby mode, Press the SmartKeys key 1 2 Either select the Monitor Standby SmartKey
. Or select the Main Setup SmartKey, then select Monitor Standby. The Standby screen is a neutral screen with information about the monitor and instructions on how to leave Standby mode. The monitor enters Standby mode automatically after the End Case function is used to discharge a patient. Standby suspends patient monitoring. All waves and numerics disappear from the display but all settings and patient data information are retained. The Standby screen is displayed. If a temporary patient location has been entered at the monitor or at the Information Center, this location will also be displayed on the Standby screen. To resume monitoring, When monitoring is resumed, alarms are paused for 1 minute to allow time to finish plugging in the measurement cables. Select anything on the screen or press any key. 28 1 Basic Operation Understanding Screens Your monitor comes with a set of pre-configured Screens, optimized for common monitoring scenarios such as "OR adult", or "ICU neonatal". A Screen defines the overall selection, size and position of waves, numerics and other elements on the monitor screen when you switch on. You can easily switch between different Screens during monitoring. Screens do NOT affect alarm settings, patient category and so forth. Switching to a Different Screen To switch to a different Screen:
1 After closing any open menus or windows, press the Main Screen key to access the Change Screen menu. 2 Choose the new Screen from the Change Screen menu. Changing a Screens Content If you do not want to change the entire Screen content, but only some parts of it, you can substitute individual waves, numerics, or trends. Be aware that these changes cannot be stored permanently in Monitoring Mode. To change the selection of elements on a Screen, 1 Select the element you want to change. For example, touch the wave to enter the wave setup menu, or touch the numeric to enter the numeric setup menu. From the menu that appears, select Change Wave or Change Numeric, and then select the wave or numeric you want. 2 In the Change Screen menu, the changed Screen is shown linked to the original Screen and marked with an asterisk. Up to three modified Screens can be accessed via the Change Screen menu. To recall Screens, select the name of the Screen in the Change Screen menu. After a patient discharge, the monitors default Screen is shown. Modified Screens are still available in the Change Screen menu. If the monitor is switched off and then on again, modified Screens are erased from the monitors memory and cannot be recalled. If a modified Screen was the last active Screen when the monitor was switched off, it is retained unless the monitor is configured to revert to the default. Using the XDS Remote Display Using the IntelliVue XDS Solution it is possible to view an independent monitor screen on an external display. The XDS Solution consists of a medical grade PC-based hardware platform, XDS Application software and the XDS connectivity option on the monitor. Depending on the configuration you can also operate the monitor from the external display. The XDS must be connected to the same Local Area Network (LAN) as the monitor. It is also possible to use an existing PC, connected to the same LAN, to host the XDS Application software. For more details, including limitations and restrictions, refer to the IntelliVue XDS Application Instructions for Use. 29 1 Basic Operation Using the Visitor Screen If a visitor Screen is configured for your monitor, you can use it to clear the screen of all waves and numerics but continue to monitor the patient with active alarms and trend storage at the bedside and Information Center. When the visitor Screen is selected, no automatic pop-up windows will be displayed. You can change the name of the visitor Screen in Configuration Mode. To activate this Screen, 1 2 Press the Main Screen key to open the Change Screen menu. Select the name of the visitor Screen configured for your monitor from the list of available Screens. To select a Screen with waves and numerics again, Touch the gray box in the center of the screen showing the visitor Screen's name, or press the Main Screen key, to open the Change Screen menu and then select a Screen from the list. Understanding Profiles Profiles are predefined monitor configurations. They let you change the configuration of the whole monitor so you can adapt it to different monitoring situations. The changes that occur when you change a complete profile are more far reaching than those made when you change a Screen. Screens affect only what is shown on the display. Profiles affect all monitor and measurement settings. The settings that are defined by Profiles are grouped into three categories. Each category offers a choice of 'settings blocks' customized for specific monitoring situations. These categories are:
Display (screens) Each profile can have a choice of many different predefined screens. When you change the profile, the screen selection configured for the new profile becomes active. Measurement Settings Each profile can have a choice of different predefined measurement settings. These relate directly to individual measurements, for example, measurement on/off, measurement color, alarms limits, NBP alarm source, NBP repeat time, temperature unit (F or C), pressure unit (mmHg or kPa). Monitor Settings Each profile can have a choice of different predefined monitor settings. These relate to the monitor as a whole; for example, display brightness, alarms off/paused, alarm volume, QRS tone volume, tone modulation, prompt tone volume, wave speed, resp wave speed, pulse source. You can change from one complete profile to another or swap individual settings blocks (display/
monitor settings/measurement settings) to change a subset of a profile. Changes you make to any element within the settings blocks are not saved when you discharge the patient, unless you save them in Configuration Mode. Depending on your monitor configuration, when you switch on or discharge a patient the monitor either continues with the previous profile, or resets to the default profile configured for that monitor. WARNING If you switch to a different profile, the patient category and paced status normally change to the setting specified in the new profile. However some profiles may be set up to leave the patient category and paced status unchanged. Always check the patient category, paced status, and all alarms and settings, when you change profiles. 30 If your monitor is configured to show the profile name in the info line at the top of the screen, be aware that individual settings may have been changed by other users or by settings synchronization since the profile was loaded. Hence settings may be different than implied by the profile name. 1 Basic Operation When you leave Demonstration Mode, the monitor uses the default profile. Swapping a Complete Profile 1 Press the SmartKeys hard key and Either select Main Setup and then Profiles in the Main Setup menu. Or select the Profiles SmartKey
. In the Profiles menu, select Profile. 2 3 Chose a profile from the pop-up list. 4 Confirm your selection. Swapping a Settings Block 1 2 3 Select the Main Setup SmartKey and then Profiles in the Main Setup menu. Select the Profile Details key. In the Profile Details menu, select Display or Measmnt.Settings or Monitor Settings to call up a list of the settings blocks in each category. 4 Choose a settings block from the pop-up list. 5 Confirm your selection. Default Profile Your monitor has a default profile that it uses when you leave Demonstration mode, or when you discharge a patient. This profile is indicated by a diamond shaped symbol. Understanding Settings Each aspect of how the monitor works and looks is defined by a setting. There are a number of different categories of settings, including, Screen Settings, to define the selection and appearance of elements on each individual Screen Measurement settings, to define settings unique to each measurement, for example, high and low alarm limits Monitor settings, including settings that affect more than one measurement or Screen and define general aspects of how the monitor works, for example, alarm volume, reports and recordings, and display brightness. You must be aware that, although many settings can be changed in Monitoring Mode, permanent changes to settings can only be done in the monitor's Configuration Mode. 31 1 Basic Operation All settings are reset to the stored defaults:
when you discharge a patient when you load a Profile when the monitor is switched off for more than one minute (if Automat. Default is set to Yes). Changing Measurement Settings Each measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu:
via the measurement numeric - select the measurement numeric to enter its setup menu. For example, to enter the Setup ECG menu, select the HR (heart rate) numeric. via the Main Setup SmartKey - if you want to setup a measurement when the measurement is switched off, use the Main Setup SmartKey and select Measurements. Then select the measurement name from the pop-up list. via the Measurement Selection key. Switching a Measurement On and Off When a measurement is off, its waves and numerics are removed from the monitors screen. The monitor stops data acquisition and alarming for this measurement. 1 Enter the measurements setup menu and select the measurement. 2 Select the measurement name to toggle between on and off. The screen display indicates the active setting. If you disconnect a transducer, the monitor replaces the measurement numeric with question marks. If you silence the resulting INOP, the measurement is switched off. Also if you pause or switch off alarms, the measurement may be switched off completely, depending on monitor configuration. Adjusting a Measurement Wave To quickly adjust wave-related measurement settings (such as speed or size), select the measurement wave itself. This displays the measurement wave menu, which has only wave-related measurement settings. Changing Wave Speeds Lowering the wave speed compresses the wave and lets you view a longer time period. Increasing the speed expands the waveform, giving you a more detailed view. The monitor distinguishes two groups of wave speed settings:
RespiratorySpeed, for CO2 waves. Global Speed, for all waves not included in the other group. 32 1 Basic Operation Changing the Wave Group Speed The wave speed group setting defines the speed of all the waves in the group. To change the wave speed of a wave speed group, 1 Select Main Setup and then select User Interface 2 Select Global Speed or RespiratorySpeed, as required 3 Select a value from the list of available speeds. Changing Wave Speed for a Channel To change the wave speed of an individual wave channel, 1 Enter the wave menu for a measurement by selecting its wave. 2 3 To set the speed to the wave group speed, select RespiratorySpeed or Global Speed. Select Change Speed. To set an individual channel speed, select a numeric value from the list of available speeds. This overrides the wave group speed setting and sets the speed for the individual wave channel on the monitor Screen. The wave channel speed is independent of the wave (label) depicted in the channel, if you change the wave, the new wave will retain the set channel speed. Using Labels You can measure up to three invasive pressures and temperatures simultaneously. The monitor uses the labels to distinguish between them. The default settings defined in the profile (such as measurement color, wave scale, and alarm settings) are stored within each label. When you assign a label to a measurement, the monitor automatically applies these default settings to the measurement. The labels assigned are used throughout the monitor, in reports, recordings, and in trends. Changing Measurement Labels (e.g. Pressure) Select Label. To change a measurement label of a measurement with multiple labels (e.g. invasive pressure or temperature), 1 Enter the wave menu of the measurement. 2 3 Choose a label from the list. The monitor automatically applies the scale, color, etc. settings stored in the Profile for the label you select. You can change scale settings in Monitoring Mode, but color can only be changed in the monitor's Configuration Mode. Any labels already being used in the monitor are shown "grayed-out" in the list and cannot be selected. Resolving Label Conflicts Each label must be unique, that is, it can only be assigned once. If you have an MMS Extension equipped with a pressure measurement connected to the monitor, there is a potential conflict with, for example, the ABP label. If you manually enter measurement values these may also conflict with existing labels on the monitor. 33 1 Basic Operation Depending on your configuration, the monitor will either display the Measurement Selection window automatically for you to resolve the conflict take no action, you must enter the Measurement Selection window (using the measurement selection key) and resolve the conflict Measurement selection key All the currently available measurements are depicted in the Measurement Selection window. Any measurement labels causing a label conflict are shown in red. If a measurement is connected but currently unavailable, for example, because it was deactivated due to a label conflict, that measurement is shown "grayed-out". If an MMS Extension is not available, for example if monitor is running on battery power and not an external power source, the MMS Extension is not displayed. 1 Unavailable measurement shown grayed-out An MMS Extension is only shown in the Measurement Selection window when the monitor is connected to AC mains via the external power supply (M8023A) or is attached to the Battery Extension (865297). To resolve a label conflict:
1 Press the SmartKeys key and Either select Main Setup and then Meas. Selection Or select the Measmt. Select. SmartKey to display the Measurement Selection window. Select the label to be corrected. 2 3 Use the measurement selection keys to resolve the conflict. Select either:
Change Label: to assign a different label to the conflicting label. 34 1 Basic Operation De- Activate: to disable the conflicting measurement. It retains its label for future use but becomes invisible to the monitor, as though it had been unplugged. Setup <Measurement Label>: to enter the Setup menu for the measurement and change the conflicting devices label to a different label. Label Compatibility When a new measurement is introduced, or new labels for an existing measurement, these labels will not be shown on older Information Centers, and consequently not on the Overview screen sourced from the Information Center. When a patient is transferred from a monitor with these new labels to one with an older software revision, the labels will be replaced with a generic label for that measurement. The settings for that generic label will then be used. If it is critical that the measurement labels are available at the Information Center and after transfers, the older monitors and the Information Center must be upgraded to the appropriate software revision. Using IntelliVue Cableless Measurements The IntelliVue CL SpO2 Pod, CL NBP Pod and CL Resp Pod, can be used together with a monitor with an SRR interface for continuous monitoring. They communicate their measurement values via short range radio to the monitor. The Cableless Measurements allow the patients more mobility without giving up continuous vital signs monitoring. Adding a Cableless Measurement Device When using an SpO2 Pod, an NBP Pod or a Respiration Pod for continuous monitoring, you need to assign the cableless measurement device to the monitor. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the NBP or SpO2 Pods, or a cl NBP Disconnect, cl SpO Disconnect or cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Adding With an RFID Reader and Tagged Cableless Devices You can directly add all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The Respiration Pod has a built-in RFID tag. The SpO2 and NBP Pods can have IntelliVue ProxiTag RFID tags adhesively attached. 1 Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. 2 35 1 Basic Operation The cableless measurement device is now added to the monitor. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the cableless measurement device by selecting Replace. If a cableless measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Adding Manually 1 2 Prepare the SpO2 or NBP Pod for adding by holding the key pressed, or the Respiration Pod by pressing the hardkey. Select the device key that appears in place of the Measurement Selection key, for example
. This displays the Add Cableless window, that shows any available IntelliVue Cableless Measurements and telemetry devices:
3 4 Select the cableless measurement device to be added. Select Add. The device confirms the successful addition with a tone. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the cableless measurement device by selecting Replace. If a cableless measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. For the SpO2 and NBP Pods, adding can also be done directly on the device. See the IntelliVue Cableless Measurements Instructions for Use for details. Removing a Cableless Measurement Device Select the Measurement Selection key. Select the cableless measurement device to be removed. Select the Remove pop-up key. To remove a cableless measurement device from a monitor and end the assignment:
1 2 3 You can also remove cableless measurement devices in the same way as any other devices using the Equipment window, see Using the Equipment Window on page 96. 36 Changing Monitor Settings To change monitor settings such as brightness, or QRS tone volume:
1 Basic Operation Press the SmartKeys key 1 2 Either Select the appropriate SmartKey for the setting you want to change
. Or Enter the Main Setup menu by selecting the Main Setup SmartKey; then select User Interface to enter a submenu where you can change the settings. Adjusting the Screen Brightness 1 2 Select the Brightness SmartKey. Select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. Optimum is suitable for most monitoring locations and optimizes power usage for battery powered monitors. Your monitor may be configured with a lower brightness for Standby mode and also for transport to conserve battery power. These settings can only be changed in the monitors Configuration Mode. Setting the Date and Time Enter the Main Setup menu by selecting the Main Setup SmartKey, then select Date, Time to enter the Date, Time menu. 1 Select, in turn, the Year, Month, Day, Hour (in 24 hour format, only) and Minute as necessary. Select the correct values from the pop-up list. Select Store Date, Time to change the date and time. 2 If your monitor is connected to an Information Center, the date and time are automatically taken from this. Once it is set, the internal clock retains the setting even when you switch off the monitor. Checking Your Monitor Revision 1 2 3 Select Main Setup then select Revisions to open the Monitor Revision menu. Select the correct device from the device pop-up keys. From the Monitor Revision menu, select the monitor component for which you need revision information. Getting Started Once you understand the basic operation principles and have completed the Training Program, you can get ready for monitoring. 37 1 Basic Operation Inspecting the Monitor WARNING If the monitor is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient. Contact your service personnel. 1 Before you start to make measurements, carry out the following checks on the monitor. Check for any mechanical damage. Check all the external cables, plug-ins and accessories. 2 Always ensure that the battery is loaded in the battery compartment when monitoring a patient, even when the monitor is running on external power. If you are using battery power, ensure that the battery has sufficient power for monitoring. When you use a battery for the first time, you must charge it, following the instructions given in the section on charging batteries in the Using Batteries chapter. 3 4 Check all the functions of that you need to monitor the patient, and ensure that the monitor is in good working order. NOTE Measurements from an MMS extension are only available when the extension is connected to the monitor, and the monitor is running on external power. This is the case when the monitor is running on AC mains via the external power supply (M8023A) or is attached to the Battery Extension
(865297). Switching On Press the power on/standby switch on the monitor for one second. The monitor performs a self test during which all lamps will light up and a tone will be sounded, and is then ready to use. If you see a message such as CO Sens Warmup wait until it disappears before starting to monitor that measurement. Power On/Power Off Behavior The general rules determining the behavior of the monitor when connected to, or disconnected from power are as follows:
A monitor that was switched on prior to a temporary power loss switches on again when power is restored. A monitor that was switched off prior to a temporary power loss remains off when power is restored. When AC mains power is lost, a battery powered monitor continues to run without interruption on battery power. Setting up the Measurements 1 Decide which measurements you want to make. 2 Connect the required patient cables and sensors. The connectors are color-coded to the patient cables and sensors for easy identification. 38 1 Basic Operation WARNING When connecting devices for acquiring measurements, always position cables and tubing carefully to avoid entanglement or potential strangulation. 3 If using IntelliVue Cableless Measurements, apply the SpO2 sensor, Respiration Pod and/or NBP cuff to the patient as described in the cableless measurements Instructions for Use. assign the cableless measurements to the monitor:
- select the Measurement Selection key
- select the Add cl Msmt pop-up key
- select the cableless measurement device to be assigned If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the assigned cableless measurement device. Starting Monitoring After you switch on the monitor, 1 Admit your patient to the monitor. 2 Check that the profile, alarm limits, alarm and QRS volumes, patient category and paced status and so forth are appropriate for your patient. Change them if necessary. 3 Refer to the appropriate measurement chapter for further details of how to perform the measurements you require. Disconnecting from AC Mains Power To disconnect the monitor from AC mains power, unplug the power cord for the external power supply (M8023A) from the mains socket. Monitoring After a Power Failure If external power is disconnected or there is a power failure, the monitor continues to run on its rechargeable battery. If the monitor is without any power (no external power or the battery is empty) for less than one minute, monitoring will resume with all active settings unchanged. If the monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the default profile will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode. 39 1 Basic Operation Networked Monitoring You can connect your monitor to an Information Center on a network, using one of the optional interfaces:
Wireless LAN IntelliVue Instrument Telemetry System (IIT). Standard wired LAN WARNING Do not connect patient monitors to the standard hospital network. If your monitor is connected to a network, a network symbol is displayed in the upper left corner next to the bed label. To see details about the monitoring equipment and technical information about the network, select the Main Setup SmartKey to enter the Main Setup menu, then select Bed Information. Be aware that some network-based functions may be limited for monitors on wireless networks in comparison to those on wired networks. Capturing Alarm Reports and Printing You can print out alarm-triggered reports with waves and vital signs, standard reports, and trends with the XDS Printing Service which is part of the IntelliVue XDS Application. This is a software package which allows you to print to a standard, off-the-shelf printer or to an electronic file such as PDF. You can download the IntelliVue XDS Application free-of-charge from the Internet and install it on an existing PC. Capturing Alarm Events The monitor can be set up to automatically capture alarm events, triggered by selected alarms. All settings must be made in Configuration mode. The output device for alarm recordings is set to "printer". This automatically makes the alarm event documentation a realtime report. The target device for realtime reports is set to "database"
The alarms to trigger the report are set up. The database is set to print automatically when a printer is available. When one of the selected alarms occurs, the monitor automatically captures the alarm and creates a realtime report which is stored in the database. As soon as the monitor is connected to a printer, or to a PC or network with the IntelliVue XDS Application software, it will automatically print the report, or send it to a patient-specific folder as an electronic file. 40 2 2What's New?
This section lists the most important new features and improvements to the monitor and its user interface introduced with each release. Further information is provided in other sections of this book. You may not have all of these features, depending on the monitor options purchased by your hospital. What's New in Release L ECG Enhancements Extended Selection for Va and Vb Chest Leads For 6-lead placement you now have an extended selection of chest leads: V1 to V9 and V3R to V6R. Specific Label Assignment for V Lead With standard 5-lead placement, the generic V lead can be configured to display with its specific position (V1 to V9 and V3R to V6R). STE Map The STE Map adds gender-specific STE limits to ST Map. ST values violating these limits are indicated in red. 12-Lead Order Management A pop-up key provides access to the order window from the Information Center. You can assign an order number from the pending list to a 12-Lead ECG waiting to be stored. This functionality requires corresponding configuration and licenses at the Information Center. Check with your Philips representative for availability. Lead Selection for Respiration Measurement It is now possible to choose between two different lead vectors for the impedance respiration measurement. Stat Admit Function The new Stat Admit function allows you to admit a patient with a temporary patient identification. It can be used in cases when the patient ID is unknown or when the data is not yet available. 41 2 What's New?
What's New in Release K.2 Cableless Respiration Measurement The new CL Respiration Pod can be used with the monitor. It is a battery-powered, cableless, respiration rate measuring device that is applied to the patient's chest using an adhesive attachment. In addition to the respiration rate it can also provide posture information and optionally a pulse measurement. Hexad Derived 12-lead ECG The Hexad ECG lead system uses a 6-lead set connected to four limb electrodes (using Mason-Likar placement) and two chest electrodes. The algorithm derives the four remaining V-leads to provide a non-diagnostic 12-lead view, including ECG waves and ST measurements. Accelerated Measurement for NBP An accelerated measurement is now available. This allows a faster measurement result but requires that the patient keeps the limb in question still. The accelerated measurement must be switched on in Configuration Mode. What's New in Release J.0 Flexible, Patient-oriented Workflow (with PIIC iX only) With the IntelliVue Information Center iX, more flexible, patient-oriented workflows are supported for admitting, tracking and transferring patients. This allows you to adapt monitor use to the patient data flow models in your specific facility and department. Managing Patients When the patient monitor is connected to an IntelliVue Information Center iX, an extended comparison of patient data allows more intelligent admission and transfer procedures. A Find Patient key can be used to search through the patient lists at the Information Center and other connected systems and take over the corresponding data found. Flexible Transfer A transfer can be initiated in the unit at the monitor, on patient arrival or patient departure, or centrally at the Information Center. Managing Equipment When used together with an Information Center iX, extended equipment management functionality is now available. Depending on how equipment is used in your facility, there are various ways to associate devices with patients, beds or monitors. Additionally there are mechanisms to automatically free up equipment that is no longer used. Using the new Equipment window you have an overview of all equipment being used for a patient, together with patient and caregiver data. 42 2 What's New?
Alarm Functionality Enhancements Pause Yellow Alarms (with PIIC iX only) - up until now, the Pause Alarms / Alarms Off key switched off or paused all red and yellow alarms. Now an alarm priority configuration setting is available to have only yellow alarms affected. Pause Alarms / Alarms Off not allowed - when the alarm priority is set to Not Allowed, alarms can no longer be switched off or paused. The Pause Alarms / Alarms Off key is disabled. Pause Alarms / Alarms Off key can be removed from the screen - a configuration setting removes the permanent key from the screen to avoid unintentional switching off of alarms. Alarms can still be switched off or paused, in the Alarms menu, under Main Setup. Alarms paused after Standby mode - alarms are automatically paused for 1 minute after Standby mode to allow time for patient connection. Capture 12-Lead ECG Enhancements (with PIIC iX only) The existing 12-Lead ECG capture functionality has been extended to offer:
Download of analysis results from the IntelliVue Information Center. Download of 12-Lead captures from the IntelliVue Information Center for review at the patient monitor. Analysis results included in reports and additional report selections with ST Map. New filter settings that are used as a default for future 12-Lead captures. Remote operation of the 12-Lead Export function at the IntelliVue Information Center. Remote operation of the 12-Lead Lock/Unlock function at the IntelliVue Information Center. New "End Afib" and "End Irregular HR" Alarms The end of an atrial fibrillation or irregular HR phase is announced with an * End AFIB or * End Irregular HR alarm. The delay time before the alarm is announced can be configured. Integrated Pulmonary Index for Microstream CO2 An Integrated Pulmonary Index (IPI) numeric is provided, that is an indication of the patient's overall ventilatory status based on four measurement parameters: etCO2, awRR, pulse rate and SpO2. Improved Visibility of Gridlines in Overlapping Waves Visibility of the gridlines for overlapping waves has been improved, and you can now configure gridlines to be shown in white, if you prefer, in a thin or thick style. Timeout for "Aged" Numerics NBP and SpO2 numerics from intermittent measurements can be configured to be grayed out or to disappear from the screen after a set time. This avoids older numerics being misinterpreted as current data. The time can be set individually for SpO2 and NBP in Configuration mode. 43 2 What's New?
What's New in Release H.0 Battery Extension The new Battery Extension provides additional battery power for situations when no mains power is available, for example during transport, and can typically power the monitor with MMS Extension for at least 6 hours. New Design for the User Interface The user interface for the patient monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background. Additionally special regard was given to improved usability and compatibility with standard software products. 12 Lead ECG Enhancements You can now preview the 12-Lead ECG at the bedside before you send it to the Information Center. A new dedicated 12-Lead ECG Report can be printed in diagnostic quality from the bedside. Support For Use of IntelliVue Cableless Measurement Devices The new Cableless Measurement Devices are patient-worn, battery powered measurement devices for SpO2 and NBP. The devices provide measurement values on the built-in display and communicate them to the monitor using a wireless short range radio (SRR) interface. They can also be controlled via SRR from an assigned patient monitor. Vital Signs Trend Based on NBP Measurement Times You can now have the NBP measurement determine the interval between the columns on the Vital Signs trend. Each NBP measurement will generate a column in the trend table. The values for the other measurements are added to the column to provide a complete vital signs set for the NBP measurement time. What's New in Release G.0?
Short Range Radio Interface for MP2 A short range radio interface is now available for the MP2 monitor. This allows a telemetry transceiver with a short range radio adapter to be assigned to the monitor, resulting in a direct connection. The measurement data from the telemetry transceiver appear directly on the monitor screen with a minimal delay and are combined with the monitor data in one sector at the Information Center. IntelliVue XDS Solution Using the IntelliVue XDS solution it is possible to view an independent monitor screen on an external display. The XDS solution consists of a medical grade PC-based hardware platform, XDS application software and the XDS connectivity option on the monitor. Depending on the configuration you can also operate the monitor from the external display. The XDS must be connected to the same Local Area Network (LAN) as the monitor. It is also possible to use an existing PC, connected to the same LAN, to host the XDS Application software. New Fields in the Admission Form A Middle Name field is now available in the admission form - whether it appears is configurable. Two additional ID fields, Lifetime Id and Encounter Id, can also be configured to appear and their names can be customized to fit hospital requirements. 44 2 What's New?
SpO2 Enhancements Additional SpO2 Labels - SpOpr and SpOpo labels have been added. New manual measurement mode when telemetry devices are connected via a short range radio link. Signal Quality Indicator displayed with the SpO2 numerics. ECG Enhancements New * AFIB / ** AFIB yellow alarm when an atrial fibrillation waveform is detected. QT View window - shows current wave and baseline wave with Q and T points marked so that you can verify that the QT algorithm detects correct Q and T points. What's New in Release F.0?
QT/QTc Interval Monitoring QT interval monitoring is used to assist in the detection of prolonged QT interval syndrome. The QT interval is measured and the heart-rate corrected QT value, QTc, is calculated. The monitor also provides a QTc value which tracks variation in the QT interval in relation to a baseline value. High alarm limits can be set for QTc and QTc enabling alarm notification. Manual Data Entry Measurement values (for example lab data or manually measured temperatures) can be entered manually into the monitor and stored in the database. They can then be used for trends, reports and also be displayed as a numeric on screen, if required. Horizon Trend Enhancements The trend indicator arrow indicates how the patient trend has developed in a set time period. This period is now configurable and can be set to 10 minutes, 5 minutes or 2 minutes. The horizon (or baseline) can now be set to a range or to a specific value. NBP - Programmable Measurement Sequence Up to four measurement cycles can be set up which will run consecutively. For each cycle you can set the number of measurements and the interval between them. By setting the last cycle to run continuously you can have regular measurements continue after the sequence has run. New Printing Options For Reports Reports can now also be printed via an external PC-based print server or to an internal print database, when no printer is available (for example, during transport). As soon as a printer becomes available, the reports stored in the database will print automatically. Manual Pairing At Monitor Previously, devices could only be manually paired at the Information Center. You can now pair devices at the monitor as long as the monitor is already connected to the Information Center. Moving Windows And Menus Windows and menus can now be moved on the monitor screen. Using touch or a mouse you can select the title of a window and then "drag" it across the screen. Some positions on the screen are not allowed, such as ones overlapping the alarm field or the monitor info line. 45 2 What's New?
Invasive Pressure Changes Wave cursor - A cursor is now available on the realtime pressure wave to allow you to define a position and store the corresponding value. Reduced alarm limit steps in lower ranges - The alarm limits setting in 2 mmHg steps is now possible in ranges up to 50 mmHg (previously up to 30 mmHg). New Patient Check The monitor can be configured to ask you in certain situations: after a specified power-off period, after a specified standby period and when no basic vitals (HR, RR, Pulse, SpO2, NBP) have been measured for a specified period, whether a new patient is now being monitored. By selecting the Yes pop-up key you can discharge the previous patient and reset settings. New Smart Keys A SmartKey is available for New Lead Setup when a new ECG lead set with fewer leads than previously is being used. Better Visibility Of Gridlines The brightness of the gridlines on the realtime waves has been increased for better visibility. 46 3Alarms 3 The alarm information here applies to all measurements. Measurement-specific alarm information is discussed in the sections on individual measurements. The monitor has two different types of alarm: patient alarms and INOPs. Patient Alarms Patient Alarms are red and yellow alarms. A red alarm indicates a high priority patient alarm such as a potentially life threatening situation (for example, asystole). A yellow alarm indicates a lower priority patient alarm (for example, a respiration alarm limit violation). Additionally there are short yellow alarms, most of which are specific to arrhythmia-related patient conditions (for example, ventricular bigeminy). INOPs INOPs are technical alarms, they indicate that the monitor cannot measure or detect alarm conditions reliably. If an INOP interrupts monitoring and alarm detection (for example, Leads Off), the monitor places a question mark in place of the measurement numeric and an audible indicator tone will be sounded. INOPs without this audible indicator indicate that there may be a problem with the reliability of the data, but that monitoring is not interrupted. Most INOPs are light blue, however there are a small number of INOPs which are always yellow or red to indicate a severity corresponding to red and yellow alarms. The following INOPs can also be configured as red or yellow INOPs to provide a severity indication:
All monitors in a unit should have the same severity configured for these INOPs. ECG Leads Off NBP Cuff Overpress Cuff Not Deflated Occlusion
<SpO Label> No Pulse
<Press Label> No Pulse Tele Disconnected Battery Empty / Replace Battery 47 3 Alarms Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the monitor. This delay has two components:
The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and, for certain measurements (SpO2, EEG and BIS), on the configured averaging time. The longer the averaging time configured, the longer the time needed until the numerical values reflect the physiological event. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay is the sum of the alarm delay configured for the specific measurement plus the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the monitor to be indicated after the measurement has triggered the alarm. See the performance specifications in the Specifications chapter for the system alarm delay specification. The alarm delay configured for a specific measurement is normally a fixed time. For SpO2 it is also possible to configure a Smart Alarm Delay that is calculated using an intelligent algorithm. See Smart Alarm Delay on page 177 in the SpO2 chapter for more details. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The monitor sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the monitor announces the most severe. Your monitor may be configured to increase alarm indicator volume automatically during the time when the alarm is not acknowledged. Visual Alarm Indicators Alarm Message An alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm. There is a field for INOPs (light blue, red or yellow) and a field for patient alarms, which is shared for red and yellow alarms. If more than one measurement is in an alarm condition, the message changes every two seconds, and has an arrow at the side. If both red and yellow alarm conditions are active simultaneously, they alternate every two seconds in the patient alarms field. The background color of the alarm message matches the alarm priority: red for red alarms, yellow for yellow alarms, light blue for standard INOPs, red for red INOPs and yellow for yellow INOPs. The asterisk symbols
(*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms, * for short yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. Depending on how your monitor is configured, it may display alarm limit violation messages:
in text form, for example ** SpO Low or in numeric form, for example **Pulse xxx>yyy where the first number shows the maximum deviation from the alarm limit, and the second number shows the currently set limit. Flashing Numeric The numeric of the measurement in alarm flashes. 48 3 Alarms Bright Alarm Limits If the alarm was triggered by an alarm limit violation, the corresponding alarm limit on the monitor screen is shown more brightly if Show ALarmLimits is enabled and there is sufficient room on the screen. Alarm Lamp A lamp on the monitor's front panel flashes. The alarm lamp is divided into two sections. The right one flashes for a patient alarm, except for short yellow alarms where the lamp will light for approximately six seconds. The color is yellow or red corresponding to the highest priority patient alarm currently present. The left one lights continuously for a light blue INOP and flashes for yellow or red INOPs as follows:
INOP Lamp Color Yellow Red On 1.0 seconds 0.25 seconds Off 1.0 seconds 0.25 seconds If only patient alarms are present, and no INOPs, the patient alarms will use both left and right sections to flash (for red and yellow alarms) or light for approximately six seconds (for short yellow alarms). If only INOPs are present, and no patient alarms, red and yellow INOPs will use both left and right sections to flash but light blue INOPs will always light continuously in the left section only. Audible Alarm Indicators The audible alarm indicators configured for your monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Alarm Tone Configuration The audible alarm indicators of your monitor are configurable. In the monitor's Configuration Mode, you can:
increase the alarm volume of unacknowledged alarms at regular intervals change the interval between alarm sounds (ISO/IEC Standard alarms only) change the base volume of the red and yellow alarm tones and the INOP tones change the alarm sound to suit the different alarm standards valid in different countries. 49 3 Alarms Traditional Audible Alarms (HP/Agilent/Philips/Carenet) Red alarms and red INOPs: A high pitched sound is repeated once a second. Two-star yellow alarms and yellow INOPs: A lower pitched sound is repeated every two seconds. One-star yellow alarms (short yellow alarms): The audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: an INOP tone is repeated every two seconds. ISO/IEC Standard Audible Alarms Red alarms and red INOPs: A high pitched tone is repeated five times, followed by a configurable pause. Two-star yellow alarms and yellow INOPs: A lower pitched tone is repeated three times, followed by a configurable pause. One-star yellow alarms (short yellow alarms): The audible indicator is the same as for yellow alarms, but of shorter duration. Standard INOPs: a lower pitched tone is repeated twice, followed by a pause. Changing the Alarm Tone Volume If you want to change the alarm volume setting, or see where the current setting is on a scale from zero to 10, select the Alarm Volume SmartKey. The volume scale pops up. The current setting is indented. To change the setting, select the required number on the scale. Any settings that are inactive ("grayed out") have been disabled in the monitor's Configuration Mode. When the alarm volume is set to zero (off), the alarm volume symbol reflects this. If you switch the alarm volume off, you will not get any audible indication of alarm conditions. Minimum Volume for No Central Monitoring INOP If your monitor is connected to an Information Center, and the connection is interrupted, the INOP message No Central Monit. will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the monitor alarm volume is set to zero. Minimum Volume for Severe Yellow or Red INOPs Severe yellow or red INOPs require action to ensure the well-being of the patient. Therefore the minimum volume for the INOP tone is set to at least alarm volume 8, irrespective of the current alarm volume setting. The INOP tone will sound even if the monitor alarm volume is set to zero. The severe INOPs for which this applies are:
Cuff Not Deflated (configurable to yellow or red) NBP Cuff Overpress (configurable to yellow or red)
!! Insert Battery (yellow) Battery Empty / Replace Battery (configurable to light blue, yellow or red) 50 Acknowledging Alarms 3 Alarms To acknowledge all active alarms and INOPs, press the Silence key. This switches off the audible alarm indicators and alarm lamps. A check mark beside the alarm message indicates that the alarm has been acknowledged
. If the monitor is configured to re-alarm, a dashed check mark will be shown
. If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a check mark symbol beside it, except for NBP alarms and alarms from other intermittent measurements. When such an alarm is acknowledged the alarm message disappears. If the alarm condition is no longer present, all alarm indicators stop and the alarm is reset. Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication. Acknowledging Disconnect INOPs Acknowledging an INOP that results from a disconnected transducer switches off the associated measurement. The only exception is ECG/Resp: acknowledging a disconnect INOP for ECG leads does not switch off the ECG and Resp measurements. Acknowledging a disconnect INOP at the Information Center switches off the audible INOP indicator but does not switch off the measurement. Alarm Reminder If Alarm Reminder is configured on for your monitor, you will get an audible reminder of alarm conditions that remain active after you have acknowledged the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. The alarm reminder behavior at the Information Center is different to that at the monitor. Refer to the Information Center Instructions for Use for further information. Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your monitor configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off. 51 3 Alarms Select Main Setup, Alarms, then Alarm Settings To view the alarm pause setting chosen for your unit, 1 2 Check the Alarms Off setting. This setting can only be changed in Configuration Mode. There are some settings made in Configuration Mode that can affect the availability of the pause alarms functionality. The Alarms key can be disabled to avoid unintentional switching off of alarms. In this case you can only pause alarms or switch alarms off permanently in the Alarms menu, under Main Setup. The Alarms key can be configured to pause or switch off red and yellow alarms, yellow alarms only, or not to function at all. If it is configured not to function, you cannot pause alarms or switch alarms off permanently. To Pause All Alarms Press the Alarms key. If your monitor is configured to infinite pause time, the lamp next to the alarms off symbol is red or yellow, depending on the configuration, and pressing this key switches alarms off. Depending on the configuration, you may need to select Confirm to complete the change. To Switch All Alarms Off You can only switch alarms off permanently if your monitor is configured to allow infinite alarms pause. Press the Alarms key. Pausing alarms infinitely is the same as switching them off. To Switch Individual Measurement Alarms On or Off 1 2 Select the measurement numeric to enter its setup menu. Select Alarms to switch between on and off. The alarms off symbol is shown beside the measurement numeric. 52 3 Alarms While Alarms are Paused or Off When red alarms are paused or off:
The red Alarms Paused lamp on the monitor front panel is lit. In the alarm field, the monitor displays the message Al. Paused x:yy or Alarms Off, together with the alarms paused symbol or the alarms off symbol. When yellow alarms are paused or off:
The yellow Alarms Paused lamp on the monitor front panel is lit. In the alarm field, the monitor displays the message YellowPaused x:yy or Yellow Alarms Off, together with the alarms paused symbol or the alarms off symbol. For red and yellow alarms:
Alarms Paused Alarms Off No alarms are sounded and no alarm messages are shown. INOP messages are shown but no INOP tones are sounded. The only exceptions are the INOPs Cuff Not Deflated, NBP Cuff Overpress and INOPs relating to empty, missing and malfunctioning batteries. These INOPs switch the alarms on, and the INOP tones are sounded, even if alarms are paused or off. You need to remove the INOP condition first before you can switch the alarm tones off again. If a disconnect INOP is present and alarms are paused or switched off, the measurement in question may be switched off, depending on monitor configuration. Restarting Paused Alarms To manually switch on alarm indication again after a pause, press the Alarms key again. Alarm indication starts again automatically after the pause period expires. If the monitor is configured to stay paused infinitely, you must select Alarms Off again to restart alarm indication. Resetting Arrhythmia Alarm Timeouts To reset the arrhythmia alarm timeout period, press the Alarms key and then press it again. Extending the Alarm Pause Time If your monitor has extended alarm pause enabled, you can extend the alarm pause time. Use this to prevent alarms being indicated, for example, while you are washing a patient or carrying out a procedure. Only extend the alarm pause time when you are sure that clinical personnel are available to monitor the patient's condition closely. To extend the alarm pause time to five or 10 minutes, 1 2 Select one of the alarm fields. This calls up the Alarm Messages window. Select either the pop-up key PauseAl. 5 min or the pop-up key PauseAl. 10 min. Each time you select one of these pop-up keys, the Alarm Pause Time is reset to five (or 10) minutes. 53 3 Alarms Alarm Settings for Unattended Monitoring When monitoring patients that are not continuously attended, use appropriate alarm settings to optimize monitoring:
Always leave alarms switched on when the patient is unattended. Recommended configuration: Use one of the temporary settings for the Alarms Off setting, not Infinite, and make sure that the AlarmOffReminder and the Alarm Reminder are switched on (these settings are made in Configuration mode). Set alarm limits so that alarms will be triggered for those changes in the patient condition that you want to be advised of. Setting limits to very high or low values can render the alarm system useless. Use available notification routes, such as a nurse call system or the connection to an Information Center, or at least select an appropriate alarm volume to ensure that alarms are recognized. Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For some measurements (for example, SpO2), where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In these cases, the alarms off symbol is not displayed. WARNING Be aware that the monitors in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Viewing Individual Alarm Limits You can usually see the alarm limits set for each measurement next to the measurement numeric on the main screen. If your monitor is not configured to show the alarm limits next to the numeric, or if the numeric is so small that the limits cannot be displayed, you can see them in the appropriate measurement setup menu. Select the measurement numeric to enter the menu and check the limits. Viewing All Alarm Limits The Alarm Limits overview window lists the currently set alarm limits for all measurements. If an Apnea alarm delay time is set, this is also shown. The alarms off symbol is shown beside the measurement label of any measurement whose alarm switched off. To open the Alarm Limits window, either select one of the alarm fields then select the Alarm Limits pop-
up key, or select the Alarm Limits SmartKey, if configured. 54 3 Alarms 1 Graphic view of current yellow and red alarm limits and currently monitored measurement value. Off indicates the measurement is switched off 2 Measurement labels, with alarms 3 off symbol where appropriate Set narrow or wide alarm AutoLimits for all measurements Select Show ST Limits to expand the list of ST leads and view the currently set alarm limits. Selecting Hide ST Limits hides the list again. You can use the pop-up keys that open with the Alarm Limits window to perform common tasks:
All Lim. Narrow/All Lim. Wide to set narrow or wide alarm AutoLimits for all measurements. These pop-up keys are not available in the window for changing individual alarm limits which you access by selecting the measurement label in the Alarm Limits window. Changing Alarm Limits To change individual measurement alarm limits using the measurement's Setup Menu, 1 In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit. Select a value from the list to adjust the alarm limit. 2 For example, to change the alarm limits for SpO2:
Touch the high limit on the alarm limits menu button. Choose the high alarm limit from the pop-up list that opens. Touch the low limit on the alarm limits menu button. Choose the low alarm limit from the pop-up list that opens. Alternatively, you can use the keys in the measurement alarm limits window, which you access by selecting the measurement label in the Alarm Limits window. 55 3 Alarms Parameter label 1 2 High red alarm (view only) 3 High yellow alarm field. Select to open a 4 5 6 7 8 pop-up list of high alarm limits Alarms On/Off key - select to toggle between alarms on or off Preview Alarm AutoLimits for a measurement before applying Select to apply wide AutoLimits Select to apply narrow AutoLimits Low yellow alarm field. Select to open a pop-up list of low alarm limits Low red alarm (view only) 9 10 Graphic view of alarm limits with currently measured value To change alarm limits, 1 Enter the Alarm Limits window. 2 To set the high alarm limit, select the high yellow alarm field to open a pop-up list of high alarm limits. Select a limit from the list. Repeat to set the low yellow alarm field. If you set the yellow alarm limit outside the red alarm limit, the monitor will automatically set the red alarm to the yellow alarm limit. When an ST measurement is in the alarm limits window there are also two pop-up keys available labeled All ST Narrow/All ST Wide. With these keys you can set Auto Limits for all ST Leads. About Automatic Alarm Limits The monitor can automatically set alarm limits suited to your individual patient, using the Automatic Alarm Limits function (AutoLimits). This tells the monitor to adapt the alarm limits of selected measurements to the measured vital signs within a defined safe limit. The monitor calculates safe AutoLimits for each patient based on the measured values from the last 12 seconds. The wide and narrow limits have a fixed relationship to the measured value within the non-
pathological range. Outside of this range, no auto limits are calculated. To set values outside of the non-pathological range, limits must be changed manually, based on the clinician's judgment about the specific patient. 56 3 Alarms 1 Wide alarm limits 2 Narrow alarm limits 3 Alarm Limits 4 Measurement value Limits Narrow sets limits close to the currently measured values for situations where it is critical for you to be informed about small changes in your patient's vital signs. Limits Wide sets limits further away from the currently measured values for situations where small changes are not so critical. Use the keys in the measurement alarm limits window to apply AutoLimits for individual measurements. These keys are not available if AutoLimits have been disabled for the measurement in the monitor's Configuration Mode. AutoLimits are not available for all measurements. The list of measurements for which AutoLimits can be used is defined in the monitor's Configuration mode. Use the measurement alarm limits window to check AutoLimits before you apply them to ensure that they are appropriate for your individual patient and their clinical condition. Once applied, AutoLimits are shown on the monitor screen just like manually-set alarm limits. If the AutoLimits are not appropriate for your patient, you must set alarm limits manually. The limits remain unchanged until you set them again or change them manually. Documenting Alarm Limits To print a list of all current alarm limit settings on an available printer:
1 2 3 Select the Main Setup SmartKey. Select Reports from the Main Setup menu. Select Alarm Limits. Reviewing Alarms You can see which alarms and INOPs are currently active in the respective alarms and INOPs fields at the top of the screen. To review the history of alarms and INOPs, select the alarms or INOPs field to open the Review Alarms window. All alarms and INOPs are erased from the Review Alarms window when you discharge a patient, or if you change to Demonstration Mode. 57 3 Alarms Review Alarms Window The Review Alarms window contains a list of the most recent alarms and INOPs with date and time information. If configured to do so, each alarm is shown with the alarm limit active when the alarm was triggered and the maximum value measured beyond this limit. The Review Alarms window also shows when the monitor was switched on (after being switched off for longer than 1 minute) and any actions related to switching alarms on and off, entering or leaving Standby mode, silencing alarms or changing the ECG source. When you select an item from the list, you can get additional information about that item. If you select a high or low limit alarm in the list, the Graphical Trends window will open to provide further data. If you select an alert other than a high or low alarm, a help text window opens with more information. Some items in the list are simply log items not related to a patient alert as such (for example, Alarms On or Alarms Off). You cannot see any further information if you select one of these items. When you close these windows you will return to the Review Alarms window. The information in the Review Alarms window is deleted when a patient is discharged, and when you leave Demonstration Mode. The Review Alarms window pop-up keys appear when the window is opened. If alarm pause extension is disabled, the pause pop-up keys are inactive. Latching Alarms The alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm. Viewing the Alarm Latching Settings In the monitor's Main Setup menu, select Alarms. Select Alarm Settings, and see the Visual Latching and Audible Latching settings. To see the alarm latching setting for your monitor:
1 2 This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings:
Visual Latching Red&Yellow Red&Yellow Red&Yellow Red Only Red Only Off Audible Latching Red&Yellow Red Only Off Red Only Off Off 58 3 Alarms Non-latching alarms Visual and audible latching Visual latching, audible Alarm Latching Behavior Red & Yellow Measurement Alarms Alarm has not been acknowledged. Alarm condition still present. Alarm tone on. Alarm lamp on. Alarm message. Flashing numerics. All audible and visual alarm indicators automatically stop. Alarm condition no longer present. Alarm has been acknowledged. Alarm condition still present. Alarm condition no longer present. Alarm tone off. Alarm lamp off. Alarm message. Flashing numerics. Audible alarm reminder (if configured). Audible and visual alarm indicators automatically stop. Alarm tone on. Alarm lamp on. Alarm message. Flashing numerics. Alarm tone on. Alarm lamp on. Alarm message. Flashing numerics. Alarm tone off. Alarm lamp off. Alarm message. Flashing numerics. Audible alarm reminder (if configured). Audible and visual alarm indicators automatically stop. non-latching Alarm tone on. Alarm lamp on. Alarm message. Flashing numerics. Alarm message. Flashing numerics. Audible alarm indicators automatically stop. Alarm tone off. Alarm lamp off. Alarm message. Flashing numerics. Audible alarm reminder (if configured). Audible and visual alarm indicators automatically stop. All INOPs are non-latching. See Yellow Arrhythmia Alarms on page 135 for information on one-
star yellow alarms latching behavior. Testing Alarms When you switch the monitor on, a selftest is started. You must check that the alarms lamps light, one after the other, and that you hear a single tone. This indicates that the visible and audible alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself (for example SpO2 or CO2) or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. Alarm Behavior at Power On restore the alarm settings from the monitor's configured default Profile, restore the most recently used alarm settings, or switch the alarms off. If the monitor is switched off for longer than one minute and then switched on again (or after a loss of power lasting longer than one minute, or when a patient is discharged), the monitor can be configured to:
After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct Profile and patient category. If power is lost for less than one minute, the alarm on/off condition prior to the power loss is restored. 59 3 Alarms Alarm Recordings You can set up your monitor so that it automatically triggers alarm recordings locally or at the Information Center, or if configured, to a printer as a realtime report. 1 2 3 4 Press the Main Setup SmartKey. Select Alarms from the Main Setup menu. Select Alarm Recording from the Alarms menu to open the Alarm Recordings menu. Select a measurement from those listed for which you want to change the alarm condition that triggers an alarm recording. This opens a pop-up list. For the desired measurement(s), choose the alarm condition to trigger an alarm recording:
Red Only: an alarm recording will automatically be triggered when the measurement enters a red alarm condition. Red&Yellow: both yellow and red alarms will trigger an alarm recording. Off: disables automatic alarm recording. 5 Refer to the Recording chapter for details of how to set up a recording. 60 4 4Patient Alarms and INOPs This chapter lists patient alarms alphabetically, and technical alarms (INOPs) arranged by the source of the INOP and then alphabetically, irrespective of their priority. All alarms and INOPs are listed here;
the ones which can appear on your monitor will depend on the model and the individual options. Patient Alarm Messages The measurement labels and abbreviations for pressure, temperature, and SpO2 alarms are explained in the individual chapters. Some alarms may be shown at the Information Center in shortened form, when transferred through IntelliVue Instrument Telemetry. These shortened alarm texts are included in the list and identified with the note "at Information Center". Alarm Message
* AFIB From ECG/Arrhythmia Atrial fibrillation waveform detected Condition
** AGT Mix MAC > 3 GM
*** Apnea
*** Apnea x:yy
*** Apnea >10 min
*** Asystole
** awRR High CO2, Resp, Spirometry, GM ECG CO2, Resp, AGM, GM An agent mixture has been detected and the sum of the 2 agent MAC components + MAC
(N2O) is 3 MAC (uncorrected) Respiration has stopped for longer than the preset apnea time. "x:yy" denotes the Apnea duration in minutes and seconds No QRS detected for a period > the asystole alarm threshold The airway respiration rate has exceeded the high alarm limit.
** awRR Low CO2, Resp, AGM, GM The airway respiration rate has dropped below the low alarm limit.
** <BIS Label> High
** <BIS Label> Low BIS BIS The Bispectral Index value has exceeded the high alarm limit. The Bispectral Index value has dropped below the low alarm limit. Indication yellow alarm lamp, short yellow alarm tone yellow alarm lamp, alarm tone. numeric flashes, red alarm lamp, alarm tone numeric flashes, red alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone 61 4 Patient Alarms and INOPs Alarm Message
*** Brady (Pulse) From SpO2, Press, cmResp Condition Pulse rate < the extreme brady alarm limit.
*** Bradypnea
** CCO High
** CCI High
** CCO Low
** CCI Low
** cmRR High
** cmRR Low
** CPP High
** CPP Low
*** Desat
*** Desat xx < yy
** EC10 Alarm
*** EC10 Alarm at Information Center
* End AFIB cmRR CCO CCO cmResp cmResp CPP CPP SpO2 The respiration rate has dropped below the bradypnea limit. Continuous Cardiac Output or CC Index is above the high alarm limit. Continuous Cardiac Output or CC Index is below the low alarm limit. The respiration rate has exceeded the high alarm limit. The respiration rate has dropped below the low alarm limit. The CPP value has exceeded the high alarm limit. The CPP value has fallen below the low alarm limit. The SpO2 value has fallen below the desaturation alarm limit. xx denotes the lowest measured value, and yy is the desaturation limit. EC10 IntelliBridge A yellow (**) or red (***) patient alarm is present on the IntelliBridge module. Check the monitor display for more detailed alarm information. ECG/Arrhythmia Atrial fibrillation no longer detected for the configured Afib end delay time Irregular HR no longer detected for the configured irregular HR end delay time. The end tidal agent high alarm limit has been exceeded.
* End Irregular HR ECG/Arrhythmia
** et<Agent Label> High GM
** et<Agent Label> Low GM The end tidal agent value has fallen below the low alarm limit
** etCO High
** etCO Low CO2, AGM, GM The end tidal CO2 high alarm limit has been exceeded. CO2, AGM, GM The end tidal CO2 value has fallen below the low alarm limit.
** etO High O2, AGM The end tidal O2 high alarm limit has been exceeded. 62 Indication numeric flashes and alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes and alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes and high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, red alarm lamp, alarm tone
(on monitor) yellow or red alarm lamp; the alarm text is defined by the IntelliBridge device driver yellow alarm lamp, short yellow alarm tone yellow alarm lamp, short yellow alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone Alarm Message
** etO Low From O2, AGM Condition The end tidal O2 value has fallen below the low alarm limit. Event surveillance An event has occurred and the event notification is configured to alarm. Check on the monitor for more details on event group. 4 Patient Alarms and INOPs Indication numeric flashes, and low limit is highlighted, yellow alarm lamp, alarm tone
(on monitor) event group name flashes, yellow or red alarm lamp and alarm tone Event surveillance An event has occurred and the event notification is configured to alarm. event group name flashes, yellow or red alarm lamp and alarm tone
* Event
** Event
*** Event at Information Center
* Event:<Event Group>
** Event:<Event Group>
*** Event:<Event Group>
*** Extreme Brady
*** Extreme Tachy
* HR High
** HR High
* HR Low
** HR Low ECG ECG ECG Heart rate < the extreme brady alarm limit. Heart rate > the extreme tachy alarm limit. Heart rate > the high HR alarm limit ECG Heart rate < the low HR alarm limit
** imCO High GM
** in<Agent Label> High GM
** in<Agent Label> Low GM
** inNO High
** inO High
** inO Low
***inO Low Oxygen
** IPI Low GM GM GM GM CO2 The inspired minimum CO2 high alarm limit has been exceeded The inspired agent high alarm limit has been exceeded The inspired agent value has fallen below the AGT low alarm limit The inspired N2O high alarm limit has been exceeded. The inspired O2 high alarm limit has been exceeded. The inspired O2 value has fallen below the low alarm limit The inspired O2 value has fallen below 18 vol%. The IPI value has fallen below the low alarm limit. numeric flashes and alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes and alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone. If configured to short yellow, the sound switches off after 5 seconds if Arrhythmia is switched on. numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone. If configured to short yellow, the sound switches off after 5 seconds if Arrhythmia is switched on. numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone. numeric flashes, high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, high limit is highlighted, yellow alarm lamp, alarm tone. numeric flashes, high limit is highlighted, yellow alarm lamp, alarm tone. numeric flashes, low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, low limit is highlighted, red alarm lamp, alarm tone numeric flashes, and low limit is highlighted, yellow alarm lamp, alarm tone 63 4 Patient Alarms and INOPs Alarm Message
* Irregular HR From ECG/Arrhythmia Consistently irregular rhythm (irregular R-R Condition
** <iTemp Label> High iTemp intervals). The temperature value has exceeded the high alarm limit.
** <iTemp Label> Low iTemp The temperature value has dropped below the low alarm limit.
* Missed Beat
* More Alarms
** More Alarms
*** More Alarms
* Multiform PVCs ECG/Arrhythmia No beat detected for > 1.75*(the averaged R-R interval), or no beat detected for > one second if HR > 120 (For non-paced patients only). There is more than one physiological alarm of the corresponding severity active on the devices that monitor this patient. For details, check the information displayed at the Information Center. other assigned devices ECG/Arrhythmia Two different shaped Vs detected, each occurring at least twice within the last 300 beats and at least once within the last 60 beats. The measured NBP value is above the high alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured NBP value is below the low alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. another assigned monitor ECG/Arrhythmia A run of PVCs < the V-Tach run limit and ventricular heart rate > the V-Tach HR limit Another monitor used for the patient is in an alarm condition. Check the detailed alarm information at the Information Center. No beat detected for > 1.75*(the averaged R-R interval) with detected pace pulse(s). (For paced patients only). No beat and pace pulse detected for >
1.75*(the averaged R-R interval). (For paced patients only). ECG/Arrhythmia
(paced patients only) ECG/Arrhythmia
(paced patients only) ECG/Arrhythmia Two ventricular beats between two non-
ventricular beats. ECG/Arrhythmia No beat detected for a period > the pause threshold. The pressure is non-pulsatile and the mean pressure is continuously less than 10 mmHg
(1.3 kPa). This alarm occurs only with arterial pressures (P, ABP, ART, Ao, BAP, FAP, PAP, UAP, P1, P2, P3, P4).
** NBP High NBP
** NBP Low NBP
* Non-Sustain VT
* OtherMon Alarm
** OtherMon Alarm
*** OtherMon Alarm
* Pacer Not Capt
* Pacer Not Pacing
* Pair PVCs
* Pause
*** <Press Label>
Disconnect PRESS 64 Indication numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes and high limit is high-lighted, yellow alarm lamp, alarm tone numeric flashes and low limit is high-lighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm yellow or red alarm lamp and alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm yellow or red alarm lamp and alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, red alarm lamp, alarm tone 4 Patient Alarms and INOPs Alarm Message
*** <Press Label> High From PRESS
** <Press Label> High PRESS
*** <Press Label> Low PRESS
** <Press Label> Low PRESS
** <pTemp Label> High pTemp
** <pTemp Label> Low pTemp Condition The measured pressure value is above the extreme high alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured pressure value is above the high alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured pressure value is below the extreme low alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The measured pressure value is below the low alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. The temperature value has exceeded the high alarm limit. The temperature value has dropped below the low alarm limit.
** Pulse High
** Pulse Low PRESS, SpO2, cmResp The pulse rate has exceeded the high alarm limit. PRESS, SpO2, cmResp The pulse rate has dropped below the low alarm limit.
* PVCs/min High ECG/Arrhythmia
** QTc High
** QTc High ECG/QT ECG/QT
* R-on-T PVCs ECG/Arrhythmia
** RR High
** RR Low RESP RESP PVCs detected within a minute > the alarm limit QTc value has exceeded the QTc high limit for more than 5 minutes QTc value has exceeded the QTc high limit for more than 5 minutes For HR < 100, a PVC with R-R interval < 1/3 the average interval followed by a compensatory pause of 1.25*(the average R-R interval), or two such Vs without compensatory pause occurring within 5 minutes of each other.
(When HR > 100, 1/3 R-R interval is too short for beat detection) The respiration rate has exceeded the high alarm limit. The respiration rate has dropped below the low alarm limit. Indication numeric flashes, high limit is highlighted, red alarm lamp, alarm tone numeric flashes, high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, red alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is high-lighted, yellow alarm lamp, alarm tone numeric flashes and low limit is high-lighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone 65 4 Patient Alarms and INOPs Alarm Message
* Run PVCs High From ECG/Arrhythmia A run of > 2 PVCs. Condition
** <SO Label> High SvO2/SO2 The the measured intravascular oxygen saturation has exceeded the high limit.
** <SO Label> Low SvO2/SO2 The measured intravascular oxygen saturation has fallen below the low limit.
** <SpO Label> High SpO2
** <SpO Label> Low SpO2
**ST Multi <n>,<n>
ECG/ST
**ST Multi at Information Center
**STE <n>,<n>
** ST-<n> High ECG/ST ECG/ST ECG/ST
** ST-<n> Low ECG/ST The arterial oxygen saturation has exceeded the high alarm limit. The arterial oxygen saturation has fallen below the low alarm limit. Two contiguous ST leads <n> and <n> have exceeded elevation or depression limits for more than 60 seconds. The limit violations for both leads must be with respect to same limit;
either both above the high limit or both below the low limit. The ST depression or elevation is outside of the limit in two or more leads. Check on the monitor Two contiguous leads <n> and <n> are above their respective STE limits The ST elevation in lead <n> is higher than the limit. Lead is not contiguous with any other lead. The ST depression in lead <n> is lower than the limit. Lead is not contiguous with any other lead. ECG/Arrhythmia A run of supraventricular beats > the SVT run limit and heart rate > the SVT HR limit. Pulse rate > the extreme tachy alarm limit. SpO2, Press, cmResp C.O. C.O. tcGas tcGas The blood temperature value has exceeded the high alarm limit. The blood temperature value has fallen below the low alarm limit. The tcpO2 or tcpCO2 value has exceeded the high alarm limit. The tcpO2 or tcpCO2 value has fallen below the low alarm limit. an assigned telemetry device A telemetry device used for the patient is in an alarm condition. Check the detailed alarm information at the Information Center.
* SVT
*** Tachy (Pulse)
** Tblood High
** Tblood Low
** tcpO High
** tcpCO High
** tcpO Low
** tcpCO Low
* Tele Alarm
** Tele Alarm
*** Tele Alarm 66 Indication numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes and high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, alarm tone
(on monitor) numeric flashes, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, alarm tone numeric flashes and high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, alarm tone numeric flashes, alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes, high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, low alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, high alarm limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, low alarm limit is highlighted, yellow alarm lamp, alarm tone yellow or red alarm lamp and alarm tone Alarm Message
** <Temp Label> High From Temp Condition The temperature has exceeded the high alarm limit.
** <Temp Label> Low Temp The temperature has fallen below the low alarm limit.
*** Vent Fib/Tach ECG
* T-Mon Alarm
** T-Mon Alarm
*** T-Mon Alarm
** TOFcnt High
* Vent Bigeminy
* Vent Rhythm
** Vent Rhythm
* Vent Trigeminy
*** VTach
** VueLink Alarm
*** VueLink Alarm at Information Center
***xBrady xxx<yyy
***xTachy xxx>yyy an assigned transport monitor NMT A transport monitor used for the patient is in an alarm condition. Check the detailed alarm information at the Information Center. TOFcnt value has exceeded the high alarm limit ECG/Arrhythmia A dominant rhythm of N, V, N, V (N =
supraventricular beat, V = ventricular beat) Fibrillatory waveform (sinusoidal wave between 2 - 10 Hz) for 4 consecutive seconds. ECG/Arrhythmia A dominant rhythm of adjacent Vs > the vent rhythm limit and ventricular heart rate < the V-
Tach HR limit. ECG/Arrhythmia A dominant rhythm of N, N, V, N, N, V (N =
supraventricular beat, V = ventricular beat). ECG, Arrhythmia A run of PVCs the V-Tach run limit and VueLink heart rate > the V-Tach HR limit. A yellow (**) or red (***) patient alarm is present on the VueLink module. Check the monitor display for more detailed alarm information. Press, SpO2, ECG This is the alternative alarm message for
*** Extreme Brady, when the alarm text setting is Enhanced. Heart rate < the extreme bradycardia alarm limit. xxx denotes the lowest measured value;
yyy is the extreme bradycardia limit. Press, SpO2, ECG This is the alternative alarm message for ***
Extreme Tachy when the alarm text setting is Enhanced. Heart rate >the extreme tachycardia alarm limit. xxx denotes the highest measured value;
yyy is the tachycardia limit. 4 Patient Alarms and INOPs Indication numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes and low limit is highlighted, yellow alarm lamp, alarm tone yellow or red alarm lamp and alarm tone numeric flashes and high limit is highlighted, yellow alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, red alarm lamp, alarm tone numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, yellow alarm lamp, short yellow audible alarm numeric flashes, red alarm lamp, alarm tone
(on monitor) yellow or red alarm lamp; the alarm text is defined by the VueLink device driver numeric flashes and alarm limit is highlighted, red alarm lamp, alarm tone numeric flashes, alarm limit is highlighted, red alarm lamp, alarm tone 67 4 Patient Alarms and INOPs Technical Alarm Messages (INOPs) If an INOP interrupts monitoring and alarm detection, the measurement numeric will be replaced by -?-. If an INOP may lead to unreliable measurement values, a ? appears next to the numeric. The measurement labels and abbreviations for pressure, temperature and SpO2 INOP messages are explained in the individual measurement chapters. Monitor INOPs INOP Message, Indication Bad MSL INOP tone Central: Tele Only INOP tone Check Alarm Lamps INOP tone Check DrugSettings INOP tone
!!Check ECG Source Yellow tone
!! Check Equipment INOP tone/Yellow tone Check Flex Texts INOP tone Check Keyboard INOP tone Check Main Board 2 INOP tone Check Monitor Func INOP tone Check Monitor Temp INOP tone Check Mouse INOP tone Check MSL Voltage INOP tone Check Network Conf INOP tone
!! Check Pairing Yellow tone
!!Check Patient ID Yellow tone 68 What to do 1) An MMS with an incompatible software revision is connected to the monitor. This combination does not allow monitoring, OR 2) You cannot use this combination of monitor, MMS and cable. Switch off the monitor and contact your service personnel. System connectivity via telemetry device is limited (No alarms, only local numerics) when in companion mode and host monitor does not have system connectivity. Only telemetry device parameters can be displayed at central station. Perform a visual check of the alarm lamp to establish whether there is a problem. Contact your service personnel to check the internal connections to the alarm lamps. There was a problem loading the drug settings. Check that the settings are complete and correct. The telemetry device and the monitor both have valid ECG signals. Unpair the telemetry device and the monitor if they are no longer used for the same patient. There is an equipment status dispute relating to one or more of the devices assigned to this patient. See the Equipment window for details. Check the names of the monitor menus, for example the labels for screens, profiles, event or trend group names, before you resume monitoring. If they are unexpected, there may be a problem with the monitor software. Contact your service personnel. Perform a visual and functional check of the keyboard. Contact your service personnel. There is a problem with the second main board in the monitor. Contact your service personnel. Potential problem with alarm lamps, display or interfaces detected. Contact your service personnel. The temperature inside the monitor is too high. Check that the monitor ventilation is not obstructed. If the situation continues, contact your service personnel. Perform a visual and functional check of the mouse input device. Contact your service personnel. There is a problem with the voltage of the Measurement Link (MSL). Contact your service personnel. The monitor is receiving network topology information from more than one source, e.g. the Database Server and an Application Server. Contact your service personnel. There is a problem with device pairing. Check that the monitor and telemetry device are correctly paired. There is a mismatch between patient data in two connected devices. Resolve the mismatch to allow settings and data synchronization. 4 Patient Alarms and INOPs What to do The Screen you have selected uses a resolution which is not supported by the display. The monitor will show a generic Screen instead until you select a different Screen. Contact your service personnel if you want the Screen deleted from the Profile(s) to avoid this in future. If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel. Perform a visual and functional check of the SpeedPoint input device. Contact your service personnel. Perform a visual and functional check of the touch input device. Contact your service personnel. The options purchased with this monitor may not support the number of waves required to show the selected Screen, so some waves or high resolution trends are missing from the Screen. Select a different Screen with fewer waves. Contact your service personnel if you want the Screen deleted from the Profile(s) to avoid this in future. The ECG Sync is detecting an invalid signal, or the ECG Sync cable is disconnected. The monitor cannot communicate with the D80 Intelligent Display. Check the MSL coupling cable. The end with the gray connector must be connected to the Intelligent Display. Synchronization of the settings for the measurement cited, has failed. Check that settings are appropriate for your patient. Check that the MSL cable is properly connected. If this is the case, try using another MSL cable, to check if your cable is defective. If this does not help, the device connected via the MSL cable may be defective, contact your service personnel. There is a problem with I2C Bus communication in the monitor. Contact your service personnel. The MSL coupling cable is reversed. Connect the end with the gray connector to the Intelligent Display. An MSL coupling cable has been connected to a device which does not support MSL coupling. An X2 has been connected to a host monitor (companion mode) and all derived measurements have been deactivated and/or measurements with a label conflict. The measurements can only be reactivated by disconnecting the measurement device from the host monitor. The monitor is associated with a telemetry device and is sending data to the Information Center via the telemetry device. There are currently more alarms at the bedside than can be transmitted to the Information Center. There is more than one technical alarm of the corresponding severity active on the devices that monitor this patient. For details check the information displayed at the Information Center. The power consumption of the devices connected to the Measurement Link (MSL) cable is too high. If this situation continues, the MSL will be switched off. Contact your service personnel. The power consumption of the devices connected to the Measurement Link (MSL) cable was too high for too long and the MSL has been switched off. Contact your service personnel. The power consumption of the devices connected to the Measurement Link (MSL) cable is much too high or there has been a short circuit. The MSL has been switched off. Contact your service personnel. INOP Message, Indication Check Screen Res. INOP tone Check Settings INOP tone Check SpeedPoint INOP tone Check Touch Input INOP tone Check Waves INOP tone Chk ECG Sync Cable INOP tone Chk IndepDsp Cable Chk <Measurement Label>Settings Chk MSL Connection INOP tone Internal.Comm.Malf INOP tone MCC Reversed INOP tone MCC Unsupported INOP tone Meas. Deactivated
!!More Bed Alarms
!!!More Bed Alarms at Information Center More INOPs
!! More INOPs
!!! More INOPs MSL Power High MSL Power Off INOP tone MSL Power Overload INOP tone 69 4 Patient Alarms and INOPs What to do There is a problem with the communication to the network. Central monitoring is currently not possible (no patient alarms or information). Check the connection. In case the connection is via a telemetry device, the current telemetry use model does not support central monitoring. Contact your service personnel. The ECG measured with the monitor ECG is not being sent to the Information Center via the telemetry device. Another monitor assigned to the patient (e.g. a transport monitor) is in an INOP condition. Check the detailed INOP information at the Information Center and resolve the INOP condition(s) at the other monitor. There is a problem with the connection to the remote alarm device. Contact your service personnel to check the remote alarm device and its connections. The monitor cannot use the predefined settings for monitoring. Contact your service personnel. Contact your service personnel to check the speaker and the connection to the speaker. The short range radio component has compatibility problems. Contact your service personnel. The short range radio connection has interference from another device. Try using another channel. The channel configuration of the Short Range Radio is invalid. Check channel and channel mask configuration. Malfunction in the short range radio device. If the INOP persists contact your service personnel. The currently selected telemetry configuration on the monitor does not allow connection of telemetry devices to the monitor. Telemetry Workflow configuration not supported. Check revision and configuration of monitor and central. The telemetry device has a malfunction. Disconnect and reconnect the telemetry device. If the INOP reappears, replace the telemetry device. SRR-enabled telemetry device is not supported by this central software revision. Please check configuration. A telemetry device assigned to the patient is in an INOP condition. Check the detailed INOP information at the Information Center and resolve the INOP condition(s) at the telemetry device. This telemetry device is not supported for direct connection to the monitor. The time has expired for the timer indicated in the INOP text. Clearing the timer clears the INOP. A transport monitor assigned to the patient is in an INOP condition. Check the detailed INOP information at the Information Center and resolve the INOP condition(s) at the transport monitor. The equipment is ready for transport. See the Equipment window for details. There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection. If the INOP persists, switch off the monitor and contact your service personnel. Perform a visual and functional check of all the monitor input devices. Contact your service personnel. INOP Message, Indication No Central Monit. INOP tone No ECG at Central OtherMon INOP
!! OtherMon INOP
!!! OtherMon INOP Rem.AlarmDev.Malf. INOP tone Settings Malfunct INOP tone Speaker Malfunct INOP tone SRR Incompatible INOP tone SRR Interference INOP tone SRR Invalid Chan INOP tone SRR Malfunction INOP tone TAAP Disabled INOP tone Tele Config Unsupp INOP tone Tele Equip Malf INOP tone Tele Incompatible Tele INOP
!! Tele INOP
!!! Tele INOP Tele Unsupported INOP tone
<Timer Label> Elapsed INOP tone T-Mon INOP
!! T-Mon INOP
!!! T-Mon INOP INOP tone TransportEquipment Unsupported LAN INOP tone User I/F Malfunct INOP tone 70 Battery INOPs INOP Message, Indication Batt 1 Missing Batt 2 Missing INOP tone During this INOP, alarms cannot be paused or switched off. Batt Empty
!!Batt Empty
!!!Batt Empty INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off. Batt Extensn Malf INOP tone Batt Incompat INOP tone Batt Low INOP tone Batt Malfunction INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power. Batteries Empty
!!Batteries Empty
!!!Batteries Empty Batt 1 Empty
!!Batt 1 Empty
!!!Batt 1 Empty Batt 2 Empty
!!Batt 2 Empty
!!!Batt 2 Empty INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off. Batteries Incompat Batt 1 Incompat Batt 2 Incompat INOP tone Batteries Low Batt 1 Low Batt 2 Low INOP tone Batteries Malfunct Batt 1 Malfunction Batt 2 Malfunction INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power. 4 Patient Alarms and INOPs What to do The monitor requires two batteries but can detect only one battery. Insert the missing battery immediately. The estimated remaining battery-powered operating time is less than 10 minutes. Replace the battery immediately. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. There is a hardware error in the Battery Extension. Contact your service personnel. The battery cannot be used with this monitor. Replace with the correct battery as specified in this book. The estimated battery-powered operating time remaining is less than 20 minutes. The monitor cannot determine the battery status. If this INOP persists, replace the faulty battery. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. Place the battery in a different monitor or in a battery charger. If the same INOP is shown, contact your service personnel. The estimated remaining battery-powered operating time of the indicated battery or batteries is less than 10 minutes. Replace the batteries immediately. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. The indicated battery or batteries cannot be used with this monitor. Replace with the correct battery or batteries as specified in this book. The estimated battery-powered operating time remaining is less than 20 minutes. The monitor cannot determine the battery status. If this INOP persists, replace the faulty battery or batteries. If the condition persists and the monitor is not connected to mains power, this INOP is re-
issued two minutes after you acknowledge it. Place the batteries in a different monitor or in a battery charger. If the same INOP is shown, contact your service personnel. 71 4 Patient Alarms and INOPs INOP Message, Indication Charge Batt 1 now Charge Batt 2 now INOP tone Charger Malfunct INOP tone, battery LED may flash Check Batt Temp INOP tone Chk MSL Connection ExtBat Empty
!!ExtBat Empty
!!!ExtBat Empty INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off. ExtBat Incompat ExtBat Low ExtBat Malfunction INOP tone, battery LED flashes During this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power. ExtBat Missing
!! Insert Battery Severe yellow INOP tone During this INOP, alarms cannot be paused or switched off. MSL Power High MSL Power Off What to do Battery must be charged. Connect the monitor to mains power or exchange the battery. There is a problem with the battery charger in the monitor. Connect the monitor to mains power and contact your service personnel. The temperature of one or both batteries is too high. Check that ventilation openings (if applicable) are not blocked and monitor is not exposed to heat. Check the MSL connection between X2/MP2 and the battery extension for damage or loose connections. Check also if a second X1 or X2 has been connected accidentally (e.g. in companion mode). The estimated battery-powered operating remaining time is less than 10 minutes. Replace the battery in the battery extension immediately. If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it. The battery in the battery extension cannot be used. Replace with the correct battery as specified in this book. The estimated battery-powered operating time remaining is less than 20 minutes. The monitor cannot determine the status of the battery in the battery extension. If this INOP persists, replace the faulty battery in the battery extension. If the condition persists and the monitor is not connected to mains power or a host monitor, this INOP is re-issued two minutes after you acknowledge it. There is no battery in the Battery Extension X2/MP2 only: There is no battery in the battery compartment. You cannot operate the monitor on AC mains or battery extension while the battery compartment is open (not sealed with a battery). Load a battery immediately. The power consumption of the devices connected to the Battery Extension is too high. If this situation continues, the Battery Extension will be switched off. Contact your service personnel. The power consumption of the devices connected to the Battery Extension was too high for too long. The Battery Extension has been switched off. Contact your service personnel. MMS, MMS Extensions and FMS INOPs INOP Message, Indication MMS Ext. Unplugged INOP tone MMS Ext. Unpowered INOP tone MMS Ext. Unsupp INOP tone MMS Ext.Equip Malf INOP tone What to do The MMS extension has been disconnected from the Multi-Measurement Module. The MMS extension cannot operate while the Multi-Measurement Module is running on battery power. The MMS extension is not supported by your monitor. Contact your service personnel. Loss of communication between the Multi-Measurement Module and the MMS extension. Contact your service personnel. 72 4 Patient Alarms and INOPs Display INOPs INOP Message, Indication Indep.Dsp Malfunc. Indep.Dsp NotSupp. Intell.Dsp Malf. Intell.Dsp Missing Intell.Dsp Unsupp. What to do There is a problem with the Independent Display. Check the MSL coupling cable then contact your service personnel. The monitor does not support a second main display. The monitor software is incompatible. Contact your service personnel. There is a problem with the Intelligent Display. Check the MSL coupling cable then contact your service personnel. The monitor has lost contact with the connected Intelligent Display. Contact your service personnel. The monitor does not support the connected Intelligent Display. The monitor software is incompatible. ECG, Arrhythmia, QT and ST INOPs INOP Message, Indication Cannot Analyze ECG Cannot Analyze QT Cannot Analyze ST Cannot Analyze STE ECG Equip Malf Numeric is replaced by -?-
INOP tone
<ECG Lead> Lead Off
!! <ECG Lead> Lead Off
!!! <ECG Lead> Lead Off If no ECG lead is measurable, numeric is replaced by -?-
INOP tone ECG Leads Off
!! ECG Leads Off
!!!ECG Leads Off Numeric is replaced by -?-
INOP tone ECG Noisy Elec <ECG Lead>
ECG Noisy Signal INOP tone ECG Out Equip Malf INOP tone ECG/Arrh AlarmsOff
!!ECG/Ar AlarmsOff What to do The arrhythmia algorithm cannot reliably analyze the ECG data. Check the ECG signal quality of the selected primary and secondary leads. If necessary, improve lead position or reduce patient motion. The QT algorithm cannot generate a valid QT value for more than 10 minutes, or 1 minute in the initial phase. The ST algorithm cannot generate a valid ST value. Possible causes are large variations in the measured ST values for consecutive beats, or ventricular paced beats. Review the ECG signal quality and the ST measurement points. If the patient has a ventricular pacemaker, ST analysis is not possible. The STE algorithm cannot generate valid ST elevation values. Possible causes are large variations in the measured ST values for consecutive beats, or ventricular paced beats. Review the ECG signal quality and the ST measurement points. Contact your service personnel. The ECG hardware is faulty. Not all the required leads for ECG monitoring are connected. Check the ECG connections and make sure that the electrode indicated by <ECG lead> is attached [e.g. RA, LA, LL, RL, V or C electrodes]. With EASI lead placement all 5 electrodes must be connected, and with Hexad lead placement all 6 electrodes must be connected. Check that all of the required ECG leads are attached, and that none of the electrodes have been displaced. The INOP may also be caused by a saturated or overloaded ECG amplifier. The ECG signal from the named ECG electrodes [RA, LA, LL, RL, V (or C)] is noisy. Check the ECG connections and make sure that the electrode indicated is attached. The ECG signal is too noisy. Check that the electrodes are properly placed and have not dried out. Remove any possible sources of signal noise (such as power cords) from the area around the cable and the patient. The ECG signal may be saturated or overloaded. There is a problem with the device connected to the ECG Out connector. Contact your service personnel. All ECG alarms have been switched off, or the HR alarm source is not ECG. To resume ECG alarm generation, switch ECG alarms on or select ECG as the alarm source. 73 4 Patient Alarms and INOPs INOP Message, Indication Some ECG AlarmsOff What to do This message appears (if configured to do so) when the on/off settings of the yellow arrhythmia alarms differ from the current Profile. Resp INOPs INOP Message, Indication Resp Equip Malf Numeric is replaced by -?-
INOP tone Resp Erratic Numeric is replaced by -?-
Resp Leads Off Numeric is replaced by -?-
INOP tone NBP INOPs INOP Message, Indication
!! Cuff Not Deflat
!!!Cuff Not Deflat Numeric is displayed with a -?-
Severe yellow/red INOP tone During this INOP, alarms cannot be paused or switched off.
!! Cuff Overpress
!!!Cuff Overpress Numeric is displayed with a -?-
Severe yellow/red INOP tone During this INOP, alarms cannot be paused or switched off. NBP Deactivated INOP tone NBP Equip Malf Numeric is replaced by -?-
INOP tone NBP Interrupted Numeric is replaced by -?-
INOP tone NBP Measure Failed Numeric may be replaced by -?-
INOP tone 74 What to do Contact your service personnel. The RESP hardware is faulty. The monitor has detected too many artifacts in the measured Resp signal. Check that the RA and LL electrodes are correctly attached and have not dried out. Not all the required leads for Resp monitoring are attached. Make sure that the RA, LA, and LL leads are attached. What to do Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try repeating the measurement. You can silence the INOP, but the INOP message remains visible until the next NBP measurement is started or the Stop All SmartKey is selected.
[Adult or pediatric patients: The NBP cuff pressure has exceeded 15 mmHg (2 kPa) for more than 3 minutes. Neonatal patients: The NBP cuff pressure has exceeded 5 mmHg (0.7 kPa) for more than 90 seconds.]
The NBP cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. The NBP measurement label in the measurement device has been deactivated by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, reactivate the measurement label in the Measurement Selection window. Remove the cuff from the patient. The NBP hardware is faulty. Contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time for inflation, deflation or the total measurement. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the condition and suitability of the patient for NBP monitoring. Use another cuff to continue measuring. 4 Patient Alarms and INOPs Temperature INOPs INOP Message, Indication T1, T2, T3, T4 INOPs Tamb INOPs Tart INOPs Tcereb INOPs Tcore INOPs
<Temp Label> Deactivated INOP tone
<Temp Label> Equip Malf Numeric is replaced by -?-
INOP tone
<Temp Label>NoTransducer Numeric is replaced by -?-
INOP tone
<Temp Label> Overrange Numeric is replaced by -?-
INOP tone
<Temp Label> Unplugged INOP tone Tesoph INOPs Tnaso INOPs Trect INOPs Tskin INOPs Ttymp INOPs Tven INOPs Tvesic INOPs SpO2 INOPs INOP Message, Indication
<SpO Label> Deactivated INOP tone
<SpO Label> Equip Malf Numeric is replaced by -?-
INOP tone What to do See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs A Temp measurement label in the measurement device has been deactivated, either by connecting a Pressure transducer in the shared Press/Temp socket, or by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, either reconnect a Temp transducer or reactivate the measurement label in the Measurement Selection window. Contact your service personnel. The temperature hardware is faulty. Make sure the Temp probe is connected to the MMS or module. If you silence this INOP, the measurement will be switched off. Try changing the application site of the transducer.
[The temperature is less than -1C, or greater than 45C.]
A Temp measurement label has been deactivated, either by unplugging a module, or by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, either replug the module or reactivate the measurement label in the Measurement Selection window. See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs See <Temp Label> INOPs What to do The SpO2 measurement label in the measurement device has been deactivated by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, reactivate the measurement label in the Measurement Selection window. The MMS or module is faulty. Unplug and replug the MMS or module. If the INOP persists, contact your service personnel. 75 4 Patient Alarms and INOPs INOP Message, Indication
<SpO Label> Erratic Numeric is replaced by -?-
INOP tone
<SpO Label> Extd.Update Numeric is displayed with a ?
(questionable numeric)
<SpO Label>Interference Numeric is replaced by -?-
INOP tone
<SpO Label> Low Perf Numeric is displayed with a ?
(questionable numeric)
<SpO Label> No Pulse Numeric is replaced by -?-
INOP tone
<SpO Label> No Sensor Numeric is replaced by -?-
INOP tone
<SpO Label> NoisySignal Numeric is replaced by -?-
INOP tone
<SpO Label> Poor Signal Numeric is displayed with a ?
(questionable numeric)
<SpO Label> Pulse?
Numeric is replaced by -?-
INOP tone
<SpO Label> Searching Numeric is unavailable
<SpO Label> Sensor Malf Numeric is replaced by -?-
INOP tone
<SpO Label> Sensor Off Numeric is replaced by -?-
INOP tone
<SpO Label> Unkn.Sensor Numeric is replaced by -?-
<SpO Label> Unplugged Numeric is replaced by -?-
INOP tone
<SpO Label> Upgrade Numeric is replaced by -?-
What to do Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The update period of displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. There is too much interference, caused by a high level of ambient light and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, make sure that the sensor cable is not damaged or positioned too close to power cables. Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site. Check the perfusion at measurement site. If necessary, stimulate circulation or change measurement site. If the INOP is due to NBP measurement on the same limb, wait until the NBP measurement is finished. Make sure the SpO2 sensor is connected. If the INOP persists, try another adapter cable and sensor. If you silence this INOP, the measurement will be switched off. Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor. The signal condition of the SpO2 measurement is poor and measurement accuracy may be compromised. If the INOP persists, consider changing the application site or using another sensor. The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. SpO2 is analyzing the patient signal to derive Pulse, SpO2 and Perf values. Please wait until the search analysis is complete. The SpO2 sensor or adapter cable is faulty. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. The SpO2 sensor is not properly applied to the patient. Apply the sensor following the instructions supplied by the manufacturer. The connected sensor or adapter cable is not supported by the SpO2 measurement. Use only specified sensors and cables. An SpO2 measurement label has been deactivated, either by unplugging a module, or by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, either replug the module or reactivate the measurement label in the Measurement Selection window. The SpO2 measurement is currently in upgrade mode. Monitoring is not possible in this mode. 76 4 Patient Alarms and INOPs What to do See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs Not all measurements or values required to perform the calculation are available. Check the measurement sources. The monitor has detected a conflict in the units used for this calculation. Check the unit settings. Pressure INOPs INOP Message, Indication ABP INOPs Ao INOPs ART INOPs BAP INOPs CPP Chk Sources Numeric is replaced by -?-
INOP tone CPP Chk Units Numeric is replaced by -?-
CPP Disabled CPP has been disabled, either in the setup in Configuration mode, or by loading settings with CPP disabled. This can happen when changing from a pediatric or neonatal profile to an adult profile, as the default profile settings have the CPP measurement disabled in the adult profile and enabled in the pediatric and neonatal profiles. Enable CPP in the current profile to clear the INOP. See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs CVP INOPs FAP INOPs IC1 / IC2 INOPs ICP INOPs LAP INOPs P / P1 / P2 / P3 / P4 INOPs PAP INOPs PPV bad <Press Label> Signal The arterial pressure source selected for PPV is not providing a pulsatile signal. The arterial pressure source selected for PPV is not providing a pulsatile signal. PPV bad Signal at Information Center PPV Chk Sources
<Press Label> Artifact Numeric questionable
<Press Label>Change Scale
<Press Label> Deactivated INOP tone
<Press Label> Equip Malf Numeric is replaced by -?-
INOP tone
<Press Label> No Pulse Pulse numeric is replaced by -?-
INOP tone
<Press Label> No Transducer Numeric is replaced by -?-
INOP tone The arterial pressure source selected for PPV is unplugged or switched off. When this INOP has displayed for 1 minute PPV will be switched off. A non-physiological event (flush or blood sample) is detected. A resulting limit alarm or non-pulsatile INOP will be suppressed. Increase the scale for the pressure wave. A Pressure measurement label in the measurement device or extension has been deactivated, either by connecting a Temp transducer in the shared Press/Temp socket, or by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, either reconnect a Pressure transducer or reactivate the measurement label in the Measurement Selection window. Contact your service personnel. The pressure hardware is faulty. This INOP can only arise when a pressure is selected as the pulse source. It occurs when the pulse rate being measured is less than 25 beats per minute or the amplitude is less than three mmHg. Check the catheter and connections to the patient. Make sure that the pressure transducer is connected to the measurement device or module. If you silence this INOP, the measurement will be switched off. 77 4 Patient Alarms and INOPs What to do This INOP can only arise when a pressure is selected as the pulse source. It occurs when the pulse detector finds a pulse rate above 350 bpm. This is usually caused by movement artifact or electrical interference. Make sure that the measurement has been properly prepared and zeroed, and that the transducer is level with the heart. If this INOP persists, try another transducer. Possible causes are a measured pressure outside the allowed pressure range, or a broken wire to the transducer. A Pressure measurement label has been deactivated, either by unplugging a module, or by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, either replug the module or reactivate the measurement label in the Measurement Selection window. Perform a zero and check the calibration of the transducer. See <Press Label> INOPs See <Press Label> INOPs See <Press Label> INOPs What to do The automatic zero calibration is in progress. This typically takes 10 seconds. During this time the CO2 values may not be updated, or they may be replaced by -?-. Wait until the zero calibration is complete to resume monitoring. Make sure that the Cal cell was changed between CAL1 and CAL2. Repeat the calibration. If the INOP reappears, try another transducer. If the INOP persists, contact your service personnel. Currently no calibration is running. Accuracy can be checked by placing the transducer on the two cells of the calstick and starting calibration. To start monitoring, leave Cal. Mode. Wait until calibration is finished. The CO2 value is outside the measurement range. Perform an accuracy check for both calstick cells and, if necessary, recalibrate the transducer. Check that the sensor is connected to the airway adapter, clean the airway adapter, if necessary. Perform a zero calibration. If the INOP persists, contact your service personnel. The CO2 measurement label in the measurement device has been deactivated by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, reactivate the measurement label in the Measurement Selection window. The Measurement Extension is faulty. Unplug and replug the Multi-Measurement Module with Extension. If you are using the mainstream method, unplug and replug the transducer or try another transducer. If the INOP persists, contact your service personnel. INOP Message, Indication
<Press Label> Noisy Signal Pulse numeric is replaced by -?-
INOP tone
<Press Label> Overrange Numeric is replaced by -?-
INOP tone
<Press Label> Unplugged INOP tone
<Press Label> Zero+Check Cal Numeric is replaced by -?-
RAP INOPs UAP INOPs UVP INOPs CO2 INOPs INOP Message, Indication CO Auto Zero Numeric is replaced by -?-
if the Autozero lasts >15 sec, INOP tone sounds. CO Cal Failed Numeric is replaced by -?-
INOP tone CO Cal Mode CO2 numeric displays current CO2 value for accuracy check CO Cal Running Numeric is replaced by -?-
CO Check Cal Numeric is replaced by -?-
INOP tone CO Chk Adapter Numeric is replaced by -?-
INOP tone CO Deactivated INOP tone CO Equip Malf Numeric is replaced by -?-
INOP tone 78 4 Patient Alarms and INOPs What to do There is no CO2 sensor connected. If you silence this INOP the CO2 measurement will be switched off. Either the sample line is disconnected, or an incorrect line is attached. Check the connection. If necessary, connect another sample line (Use only the approved accessories). If you silence this INOP, the measurement will be switched off. The sample line or exhaust tube is blocked. Check the tubing, then disconnect and reconnect the sample line. If the INOP persists, connect a new sample line. The CO2 value is higher than the measurement range. If you suspect a false high value, contact your service personnel. The pump has been switched off for fifteen minutes. To switch it on again, select Pump On in the Setup CO menu. The Filterline is being purged to remove an occlusion in the line or airway adapter. If the occlusion is removed, the INOP will disappear. If not, the INOP CO Occlusion is displayed. Wait until the sensor reaches operating temperature and the INOP disappears. The software in the Measurement Extension does not match the software in the MMS. Contact your service personnel. Calibration on the first calstick cell is complete. Place the transducer on the other calstick cell and start the CAL2 calibration cycle. An error occurred during the last zero calibration. Check the airway adapter and clean, if necessary. Perform another zero calibration. If the INOP persists, contact your service personnel. The CO2 wave is clipped. Select a more appropriate wave scale to display the whole wave. There is no CO2 transducer connected. If you replace the transducer, the new transducer must be calibrated. If you silence this INOP the CO2 measurement will be switched off. Wait until zero calibration is finished. Perform zero calibration for the CO2 sensor. If the INOP persists, contact your service personnel. For Adult patients: a date of birth has been entered that results in a calculated patient age of less than 12 years. Enter correct date of birth or, if patient is pediatric, correct patient category. For pediatric patients: either no date of birth has been entered (it is required for calculation of IPI for pediatric patients) or the calculated age is below 1 year or above 12 years. Check that correct date of birth is entered. The IPI numeric cannot be provided as one or more of the measurement sources required for IPI is not available. Check availability of etCO2, awRR, SpO2, and pulse rate. Check patient category. The IPI numeric is not available for neonatal patients. INOP Message, Indication CO No Sensor from M3014A Numeric is replaced by -?-
INOP tone CO No Tubing Numeric is replaced by -?-
INOP tone
!! CO Occlusion
!!! CO Occlusion Numeric is replaced by -?-
INOP tone CO Overrange Numeric is replaced by -?-
INOP tone CO Pump Off Numeric is replaced by -?-. CO Purging Numeric is replaced by -?-
INOP tone CO Sens Warmup Numeric is replaced by -?-
Microstream CO2: INOP tone Mainstream CO2: no INOP tone CO Upgrade FW Numeric is replaced by -?-
INOP tone CO Wait Cal2 Numeric is replaced by -?-
CO Zero Failed Numeric is replaced by -?-
INOP tone COChange Scale CONoTransducer from mainstream CO2 (except M3014A) Numeric is replaced by -?-
INOP tone COZero Running COZeroRequired Numeric is replaced by -?-
INOP tone IPI Check Pat. Age IPI Check Sources IPI Neo Patient ?
79 4 Patient Alarms and INOPs C.O. INOPs INOP Message, Indication C.O. Deactivated INOP tone C.O. Equip Malf Numeric is replaced by -?-
INOP tone C.O. Unplugged Numeric is replaced by -?-
INOP tone CCI No BSA CCI numeric unavailable INOP tone CCO BadPressSignal Numeric is replaced by -?-
INOP tone CCO No Calibration Numeric is replaced by -?-
CCO No <Press Label>
Numeric is replaced by -?-
INOP tone may sound CCO No Press at Information Center CCO Not Supported Numeric is replaced by -?-
INOP tone CCO Overrange CCI Overrange Numeric is replaced by -?-
INOP tone CCO Press Invalid at Information Center CCO <Press Label> Invalid Numeric is replaced by -?-
INOP tone may sound CCO PressOverrange Numeric is replaced by -?-
INOP tone CCO PulseOverrange Numeric is replaced by -?-
INOP tone CCO Recalibrate Numeric is replaced by -?-
80 What to do The Cardiac Output measurement label in the measurement device has been deactivated by deactivating the label in the Measurement Selection window. The measurement automatically disappears from the display. To switch the measurement on again, reactivate the measurement label in the Measurement Selection window. There is a problem with the C.O. hardware. Contact your service personnel. Plug in the C.O. module. Silencing this INOP switches off the measurement. CCI cannot be calculated because the patient's body surface area is unknown. Enter the patient weight and height to provide the BSA for CCI calculation. The arterial pressure wave can currently not be used for pulse contour calculation for CCO or CCI measurement. Possible causes are air bubbles in the tubing or a physiological condition, for example severe arrhythmia. The CCO measurement is currently not calibrated. CCO/CCI cannot be calculated. Make sure that the pressure chosen in the Setup CCO menu under CCO from matches the pressure measured with the arterial catheter for CCO measurement. A pressure from an external device cannot be used. Select another pressure label, either ABP, Ao, ART, BAP, FAP, or UAP. CCO/CCI cannot be calculated. Make sure that the pressure chosen in the Setup CCO menu under CCO from matches the pressure measured with the arterial catheter for CCO measurement. A pressure from an external device cannot be used. Select another pressure label, either ABP, Ao, ART, BAP, FAP, or UAP. A catheter for transpulmonary C.O. measurements has been unplugged and replaced with a Right Heart C.O. catheter, or the measurement mode has been changed manually. Silencing this INOP switches the measurement off. The measured CCO or CCI value is not within the specified range for CCO/CCI measurement. The arterial pressure selected for pulse contour calculation for CCO is available but currently invalid. Make sure the pressure transducer is connected and the zero calibration is valid. The arterial pressure selected for pulse contour calculation for CCO is available but currently invalid. Make sure the pressure transducer is connected and the zero calibration is valid. The mean value of the arterial pressure values used for pulse contour calculation for CCO is below 0 mmHg or above 300 mmHg. The pulse rate of the pressure used for pulse contour calculation for CCO is below 30 bpm or above 240 bpm. The most recent CCO or CCI calibration was made over 8 hours ago or the arterial pressure measurement used for CCO calculation has been zeroed after the CCO calibration was performed. You should recalibrate CCO or CCI with transpulmonary C.O. measurements at least every 8 hours or when the hemodynamic condition of the patient has changed. The pressure measurement must be zeroed before a CCO calibration. 4 Patient Alarms and INOPs What to do No transducer attached to the module or catheter disconnected. Tblood out of range 17C - 43C. No transducer attached to the module or catheter disconnected. What to do Synchronization of ECG settings between the monitor and Information Center has failed. Check that the ECG settings in use are appropriate. Both the telemetry device and the monitor have valid ECG signals Synchronization of SpO2T settings between the monitor and Information Center has failed. Check that the SpO2T settings in use are appropriate. The leadset plugged in cannot be used with the telemetry device. The leadset has been unplugged from the telemetry device. A telemetry device is paired with the monitor but the Information Center is not detecting a valid ECG signal from either of them. The battery in the telemetry device is almost empty and must be replaced. INOP Message, Indication CCO/Tbl NoTransduc Numeric is replaced by -?-
INOP tone Tblood Overrange Numeric is replaced by -?-
TbloodNoTransducer Numeric is replaced by -?-
INOP tone Telemetry INOPs INOP Message, Indication Check ECG Settings INOP tone
!!Check ECG Source Chk SpOT Settings INOP tone Invalid Leadset Leadset Unplugged No ECG Source
!! Repl. Tele Batt
!!!Repl. Tele Batt Severe yellow/red INOP tone During this INOP, alarms cannot be paused or switched off. Tele Battery Low
!!Tele Disconnect
!!!Tele Disconnect Severe yellow/red INOP tone The battery in the Telemetry device is low and must be replaced soon. Telemetry transceiver was disconnected or short range radio link was lost. For cable connections; check Telemetry interface, cable connection and setup. For short range radio connections: if the telemetry transceiver has not moved out-of-range, check for interference sources close to the monitor (bluetooth devices, DECT phones, cellular phones, microwaves, etc.). If this INOP persists, ask your service personnel to survey the interference sources. Check for further details at the Information Center or in the Telemetry Data window on the monitor. The MMS in use does not support synchronization of ECG and SpO2 settings between the monitor and central station after a telemetry device has been paired. Use an MMS with revision E.0 or above.
!! Tele INOP
!!! Tele INOP Severe yellow/red INOP tone Tele Sync Unsupp. INOP tone Cableless Measurement Device INOPs INOP Message, Indication cl NBP Batt Empty
!!cl NBP BattEmpty
!!!cl NBP BatEmpty Corresponding INOP tone cl NBP Batt Incomp INOP tone What to do The remaining battery time of the NBP Pod is below 30 minutes. Charge the battery. The battery in use with the NBP Pod is incompatible. Replace it with one approved for use with the NBP Pod. 81 4 Patient Alarms and INOPs INOP Message, Indication cl NBP Batt Low INOP tone cl NBP Batt Malf INOP tone cl NBP Batt Temp INOP tone cl NBP Check Batt INOP tone cl NBP Chk Chrg IF cl NBP ChkSettings cl NBP Disconnect INOP tone cl NBP License Req cl NBP No Cradle INOP tone cl NBP Remove INOP tone cl NBP Serv Batt INOP tone cl Resp Batt Empty
!!cl Resp BatEmpty
!!!cl Resp BtEmpty Corresponding INOP tone cl Resp Batt Incmp INOP tone cl Resp Batt Low cl Resp Batt Malf cl Resp Batt Temp cl Resp Check Batt cl Resp Chk ChrgIF cl Resp Chk Sett cl Resp Disconnect cl Resp Remove cl Resp Serv Batt cl SpO Batt Empty
!!cl SpO BatEmpty
!!!cl SpO BtEmpty Corresponding INOP tone cl SpO Batt Incmp INOP tone 82 What to do The remaining battery time of the NBP Pod is below 2 hours. There is a malfunction in the NBP Pod's battery system. Contact your service personnel. The temperature of the battery in the NBP Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient and contact your service personnel. The battery in the NBP Pod is nearing the end of its useful life. Only 50 charge/discharge cycles remain. Contact your service personnel to replace the battery. The interface between the NBP Pod and the Charging Station is not working properly. Try cleaning the contacts and reposition the Pod on the charging station. The NBP Pod's settings may have changed or become corrupt. Check the settings. The NBP Pod has lost the connection to the monitor. The NBP Pod requires a valid software license for operating. The NBP Pod is not in its cradle. The temperature of the battery in the NBP Pod is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. The battery in the NBP Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. The remaining battery time of the Respiration Pod is below 30 minutes. Charge the battery. The battery in use with the Respiration Pod is incompatible. Replace it with one approved for use with the Respiration Pod. The remaining battery time of the Respiration Pod is below 2 hours. There is a malfunction in the Respiration Pod's battery system. Contact your service personnel. The temperature of the battery in the Respiration Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient and contact your service personnel. The battery in the Respiration Pod is nearing the end of its useful life. Only 50 charge/discharge cycles remain. Contact your service personnel to replace the battery. The interface between the Respiration Pod and the Charging Station is not working properly. Try cleaning the contacts and reposition the Pod on the charging station. The Respiration Pod's settings may have changed or become corrupt. Check the settings. The Respiration Pod has lost the connection to the monitor. The temperature of the battery in the Respiration Pod is too high. Remove the Pod from the patient and contact service personnel. The battery in the Respiration Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. The remaining battery time of the SpO2 Pod is below 30 minutes. Charge the battery. The battery in use with the SpO2 Pod is incompatible. Replace it with one approved for use with the SpO2 Pod. 4 Patient Alarms and INOPs INOP Message, Indication cl SpO Batt Low INOP tone cl SpO Batt Malf INOP tone cl SpO Batt Temp INOP tone cl SpO Check Batt INOP tone cl SpO Chk ChrgIF cl SpO Chk Sett cl SpO Disconnect INOP tone cl SpO No Cradle INOP tone cl SpO Remove INOP tone cl SpO Serv Batt INOP tone clResp License Req clSpO License Req cmResp NeoPatient?
cmResp No Signal cmRespCan'tAnalyze cmRespPediPatient?
What to do The remaining battery time of the SpO2 Pod is below 2 hours. There is a malfunction in the SpO2 Pod's battery system. Contact your service personnel. The temperature of the battery in the SpO2 Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient and contact your service personnel. The battery in the SpO2 Pod is nearing the end of its useful life. Only 50 charge/discharge cycles remain. Contact your service personnel to replace the battery. The interface between the SpO2 Pod and the Charging Station is not working properly. Try cleaning the contacts and reposition the Pod on the charging station. The SpO2 Pod's settings may have changed or become corrupt. Check the settings. The SpO2 Pod has lost the connection to the monitor. The SpO2 Pod is not in its cradle. The temperature of the battery in the SpO2 Pod is too high. Remove the SpO2 Pod from the patient and contact service personnel. The battery in the SpO2 Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery. The Respiration Pod requires a valid software license for operating. The SpO2 Pod requires a valid software license for operating. The Respiration Pod cannot be used with neonatal patients. Check the patient category. No signal is being detected from the Respiration Pod. Check that the Pod is attached correctly with the adhesive attachment and that it moves with the patient's breathing. The Respiration Pod algorithm cannot reliably analyze the signal. Respiration rate and pulse rate are affected The Respiration Pod cannot be used with pediatric patients. Check the patient category. 83 4 Patient Alarms and INOPs 84 5 5Managing Patients and Equipment When the monitor is used together with an IntelliVue Information Center, a variety of services are provided to manage the interconnections between patients, equipment, hospital beds, caregivers, and so on. Many services can be used both at the monitor and at the Information Center, resulting in a more efficient workflow. Which services are available will depend on which Information Center you have. The Philips IntelliVue Information Center iX (PIIC iX) provides more services and functionality than the Philips IntelliVue Information Center (PIIC). In these Instructions for Use, information that is only valid for one of the Information Centers will be marked with a corresponding side heading, for example PIIC iX For a list of the differences between the two Information Centers, see Information Center Compatibility on page 103. Patient Concepts For a patient to be part of the system their identification data must be entered into the system. A patient can then be assigned to a bed, have equipment assigned directly to him, and have a location set when he is not currently in the bed. Equipment Concepts Depending on how equipment is used in your facility, there are various ways to associate devices with patients, beds or monitors. Equipment usage must be configured appropriately at the Information Center and the monitoring equipment. PIIC iX By configuration, equipment can be assigned:
permanently to a bed, on demand to a bed or host monitor, or directly to a patient. The foundation for a particular equipment use model is laid in the configuration settings in the monitor and the Information Center. Refer to the corresponding configuration guides for further details. 85 5 Managing Patients and Equipment Additionally there are mechanisms to automatically free up equipment that is no longer used. This prevents unnecessary patient mismatches when the equipment is used for the next patient and avoids data of different patients getting mixed. PIIC iX When connected to PIIC iX, equipment states are tracked by the system. When the equipment is not assigned to a patient or no patient is admitted at a monitor, the equipment is considered as free equipment in the system. Equipment that is assigned or has a patient admitted is tracked as used (i.e. not free) equipment. The Information Center uses the equipment state (free/not free) to maintain and support workflow and equipment lists. Managing Patients In order to attribute collected measurement data to a specific patient, or assign equipment or a bed to a specific patient, each patient in the system must be identified. By admitting a patient, you identify them for the system. When equipment is freed up (for example by discharging the patient, removing a monitor from a patient or using End Case) the collection of data is officially ended for this patient and important settings on the monitor are reset to the defaults. WARNING Always perform a discharge or free up the monitor before starting monitoring for a new patient, even if your previous patient was not admitted. Failure to do so can lead to data being attributed to the wrong patient. Admitting a Patient The monitor displays physiological data and stores it in the trends as soon as a patient is connected. This lets you monitor a patient who is not yet admitted. It is however important to admit patients properly so that you can identify your patient on recordings, reports, and networked devices. During admission you enter data that the monitor needs for safe and accurate operation. For example, the patient category setting determines the algorithm the monitor uses to process and calculate some measurements, the safety limits that apply for some measurements, and the alarm limit ranges. NOTE It is strongly recommended that the same patient data fields be configured to be mandatory at the monitor and the Information Center. When No Patient is Admitted To admit a patient:
1 Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window. Select Admit Patient. The Enter Demographics window appears. You can enter data as normal, using the keyboard or a barcode scanner, or, with PIIC iX, use the Find Patient key to search for patient data in connected systems as described in Using "Find Patient" to Search for Patient Data on page 87. 2 86 5 Managing Patients and Equipment 3 Enter the patient information: select each field and use the keyboard or barcode scanner or choose from the pop-up list of alternatives to input information. When you enter data, the Information Center will automatically check for corresponding data and will suggest an appropriate action based on what it finds. You can select Confirm to accept the suggestion or Cancel to reject it. Middle Name (if configured to appear): Enter the patient's middle name. Last Name: Enter the patient's last name (family name). First Name: Enter the patient's first name. Lifetime ID, Encounter ID: Whether these fields appear and how they are labeled can be configured for your hospital. One or both fields may be displayed and the labels may read:
MRN, Case ID, Visit Number, or other alternatives. Enter the appropriate data for the fields displayed. Patient Cat.: Choose the patient category, either Adult, Pedi, or Neo. Paced Mode: Choose On or Off (You must use On if your patient has a pacemaker). With PIIC iX there is a third choice: Unconfirmed. When the paced mode is Unconfirmed, the algorithm for paced patients will be used. BSA: The monitor calculates the body surface area automatically. Age: The monitor calculates the patient age automatically. Gender: Choose Male or Female. Height: Enter the patient's height. Weight: Enter the patient's weight. Date of Birth: Enter the patient's date of birth, in the form dd/mmm/yyyy. Notes (1) / Notes (2): Enter any extra information about the patient or treatment. When admission is complete, the patient's name appears on the monitor info line at the top of the screen together with the symbol indicating the patient category. By clicking on this section of the information line, also when no patient is admitted, you can open the Patient Demographics window at any time. There you can change patient data or set patient category and paced mode as described above. When a Patient is Already Admitted If the patient monitor already has a patient admitted, the Admit Patient key is replaced by the New Patient key. When you select New Patient, the monitor is freed. All settings are reset to the defaults, all patient data and trend data are deleted, and monitoring at the Information Center may stop for monitors designated as transport monitors. Depending on your equipment configuration, selecting New Patient may transfer the currently admitted patient out of the bed. A message will appear requiring your confirmation of these actions. After selecting New Patient, you can admit your patient as described in When No Patient is Admitted above. Using "Find Patient" to Search for Patient Data PIIC iX You can use the Find Patient key to search for patient data in the Information Center and any connected hospital information systems. The search will look for currently admitted or previously admitted patients matching the search data you enter. 87 5 Managing Patients and Equipment To search for patient data:
1 Select the Find Patient key. A window opens with an on-screen keyboard. 2 Type in the last name or an ID, or a part of it, and select Enter on the keyboard. The search results will be displayed in a Select Patient window. The system provides a list of all matching patients. 3 Highlight the patient you want to admit to this bed. 4 Depending on their current status, you will be asked whether you want to readmit them, or transfer them to this bed. Select Confirm to complete the admission or transfer. 5 Patient Category and Paced Mode The patient category setting determines the algorithm the monitor uses to process and calculate some measurements, the safety limits that apply for some measurements, and the alarm limit ranges. The paced mode setting determines whether the monitor shows pacemaker pulses or not. When Paced Mode is set to Off, pace pulses are filtered and therefore do not show in the ECG wave. WARNING Patient Cat. and Paced Mode will always contain a value, regardless of whether the patient is fully admitted or not. If you do not specify settings for these fields, the monitor uses the default settings from the current profile, which might not be correct for your patient. Patient category Changing the patient category may change the arrhythmia and NBP alarm limits. If possible, always load a suitable profile after changing patient category, and always check alarm limits to make sure that they are appropriate for your patient. Paced mode For paced patients, you must set Paced Mode to On. If it is incorrectly set to Off, the monitor could mistake a pace pulse for a QRS and fail to alarm during asystole. With PIIC iX, the paced mode may be Unconfirmed which will assume a pacemaker is present. You should still set the Paced Mode to On for paced patients to make the status clear. Admitting a Centrally-Monitored Patient You can admit a patient at either the bedside or the Information Center. When you admit a patient, the patient's name appears on the bedside monitor and the Information Center. If you do not fill in all patient information required by the Information Center, the Information Center may reject the admission. Complete all the required fields and try again to admit the patient. Quick Admitting a Patient Use Quick Admit to quickly admit a patient using only a limited set of demographic data. 1 2 Enter the required data (ID fields or last name depending on configuration) with the keyboard or a Select the Quick Admit SmartKey. barcode scanner. 88 5 Managing Patients and Equipment 3 4 Select Enter. In the confirmation window, select Confirm to stop monitoring for the previous patient or free up the monitor (if confirmation is configured). 5 Check that patient category and paced status are correct for the new patient. 6 Check the current profile and, if necessary, load an appropriate profile. If the monitor is connected to an Information Center and only the ID field is entered, the patient name may be set to - - - at the Information Center, depending on the configuration. Complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields. Using Stat Admit Stat Admit allows you to admit a patient with a temporary patient identification. It can be used in cases when the patient ID is unknown or when the data is not yet available. The Stat Admit function generates content for a name or ID field using the current date and time. A random lower case letter is added at the end to reduce the chance of creating the same name or ID simultaneously at two monitors. So a name field would be filled with, for example:
19:32:45-30MAR15a Depending on your configuration, a name field, an ID field, or all fields defined as mandatory will be filled. The exact format of the date and time data depends on the size of the field being filled and the language of the monitor user interface. Additionally, if configured, Stat Admit can enter the current bed label or equipment label as a record of the location at admission time. Admitting with Stat Admit If Stat Admit is available for use, one of the following two methods will be set up:
Using the SmartKey - select the Stat Admit Smartkey. Using a barcode or RFID label - read the special Stat Admit code. Depending on your configuration, either the temporary ID will appear directly on the monitoring screen or the Enter Patient Demographics window will open for you to confirm the temporary ID. Editing Patient Information To edit the patient information after a patient has been admitted, select the patient name field on the Main Screen to open the Patient Demographics window, and make the required changes. PIIC iX If data has been provided by a hospital information system, you will not be able to edit it on the monitor. Ending Monitoring for a Patient There are several ways to end monitoring for a patient, depending on whether there is an Information Center connection, and on the configuration of the Information Center and the monitor. Discharging a patient and removing the monitor from a patient are described here. You can also end monitoring by admitting a new patient, as described in When a Patient is Already Admitted on page 87. 89 5 Managing Patients and Equipment Depending on your configuration, monitoring for a patient may end automatically when the monitor has been powered off or in standby mode for a set time, or when no basic measurements have been made for a set time. WARNING Always end monitoring for the previous patient (with Dischrge Patient, Remove Monitor, End Case or New Patient) before starting monitoring for a new patient, even if your previous patient was not admitted. Failure to do so can lead to data being attributed to the wrong patient. Discharging a Patient The discharge function is only available when the patient is monitored centrally at an Information Center. A discharge transfers the patient out of the bed and frees all devices used for the patient. The discharge function may be disabled at a monitor designated as a transport monitor, to ensure that a patient cannot be accidentally discharged from the system when the transport monitor is used for another patient. A discharge:
clears the patient demographics erases all patient measurement data (such as trend, event, and calculation data) from the monitor, measurement modules and Information Center. This ensures that data from a previous patient are not mixed with data from a new patient. resets patient category and paced settings to the settings defined in the default Profile resets all monitor and measurement settings as well as the active Screen to the settings defined in the default Profile discharges the patient from the Information Center. Make sure that you have printed out any required reports before discharging. Check that a functioning local or central printer is available before you use End Case. To Discharge a Patient 1 Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window and associated pop-up keys. Select the pop-up key for either:
End Case - to print any configured end case reports or vital signs recording, discharge the patient and clear the patient database, then enter standby mode. If an End Case SmartKey is configured for your monitor, you can also select this instead and then confirm. To see which end case reports are set up for your monitor, select Main Setup, Reports, then Auto Reports. For each auto report, if End Case Report is set to On, this report will be printed when you select End Case. See Setting Up Auto Reports on page 237 for information on setting up end case reports. Dischrge Patient - to discharge the patient without printing any reports. 2 90 5 Managing Patients and Equipment Removing the Monitor Removing a monitor stops using the monitor for the current patient and frees up the monitor and all devices assigned to that monitor. Removing the monitor:
clears the patient demographics in the monitor. erases all patient measurement data (such as trend, event, and calculation data) from the monitor and devices assigned to the monitor. This ensures that data from a previous patient are not mixed with data from a new patient. resets patient category and paced settings to the settings defined in the default Profile. resets all monitor and measurement settings as well as the active Screen to the settings defined in the default Profile. If the monitor is locked to the bed and is connected to an Information Center, the remove function is not available and you will have to discharge the patient. To Remove a Monitor 1 Open the Equipment window - either directly in Main Setup or by selecting the bed label in the information line. Select the monitor. Select the Remove Monitor pop-up key. 2 3 New Patient Check after a specified power-off period after a specified standby period The monitor can be configured to ask you whether a new patient is now being monitored in certain situations:
when no basic vitals (HR, RR, Pulse, SpO2, NBP) have been measured for a specified period The pop-up window is entitled Is this a New Patient?. The monitor offers a Yes key to stop monitoring for the previous patient and begin monitoring a new patient and a No key to continue monitoring with the current patient data and settings. The time periods for the three conditions can be configured independently. Transferring Patients To save you from having to enter the same patient data multiple times and enable patient transfer without loss of data, patient demographic information is shared between patient monitors and Information Centers. Data Exchange Between Information Centers You can transfer demographic data and trend data from one IIC to another by selecting Transfer on the patient monitor. Trend data is not shared between Information Centers and monitors. 91 5 Managing Patients and Equipment Transferring Patients with IntelliVue Information Center iX PIIC iX There are several ways to transfer a patient from or to another bed. When a patient is transferred to the destination bed, Information Center monitoring continues in the destination bed and equipment that is not transferred with the patient is freed up. Using the Transfer Function PIIC iX To transfer a patient using the transfer function provided on the patient monitor by the Information Center:
1 2 4 5 Select the patient name or the Not Admitted text at the top of the monitor screen to open the Patient Demographics window. Select the Transfer pop-up key. The Transfer window opens. If a patient is currently admitted, the window offers the possibility to transfer that patient to another bed (To Other Bed). If no patient is currently admitted, the window offers the possibility to transfer a patient from another bed using the patient search as described in Using "Find Patient" to Search for Patient Data on page 87. 3 With To Other Bed, if more than one unit is configured, a list of units will appear. When you have selected a unit, or if only one unit is configured, a list of free beds will appear. Select a bed from the list. You will be asked to confirm the transfer of the patient to this bed. Select Confirm to complete the transfer. WARNING Before doing a transfer ensure that no other patient is using the destination bed and/or equipment from the destination bed. When a patient is transferred you need to check that the patient has all the required monitoring equipment at the destination bed. Using the New Patient Key PIIC iX If the monitor at the destination bed is not free:
1 2 3 Select the patient name field at the top of the monitor to open the Patient Demographics window. Select New Patient to free up the monitor. Select Find Patient and enter your patient's name to get the patient data from the system. When you select your patient from the list, you will be asked to confirm that the patient should be transferred into this bed. After confirmation the transfer is complete. 92 5 Managing Patients and Equipment Transferring Patients with IntelliVue Information Center Transferring a Centrally-Monitored Patient with the Monitor Scenario: A centrally-monitored patient is moved with the monitor to another monitoring location on the same Information Center database server without interrupting the collection of patient trend information. 1 Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window, then select the Transfer pop-up key. If the patient is not admitted or not monitored by an Information Center, the Transfer key is inactive ("grayed-out"). This step preserves the patient's demographic data during the transfer. 2 At the new location, connect the monitor to the network (only needed for wired networks). If the monitor detects a patient mismatch, a window will open showing your patient's data and asking Complete transfer of this patient?. Select Yes to complete the transfer. 3 4 Verify that the settings for patient category and paced mode are correct. If you accidentally transfer a patient, use Re-Admit to restore this patient's data to the Information Center. If you are not connected to the network, select Clear Transfer to leave transfer mode. The patient data remains in the monitor. Resolving Patient Information Mismatch When you connect together devices which store patient demographic data, for example, a monitor and an Information Center, the system compares patient category, paced status, and unique patient identification in order to synchronize this information. If configured to do so, the monitor indicates a mismatch if the information is not identical. WARNING It is important to resolve the mismatches as soon as they are identified. Failure to do so could result in using incorrect/confusing data to make clinical decisions. Certain settings, for example Paced Mode and Patient Cat., may not match between the Information Center and the monitor. If the Paced Mode is set incorrectly, the system could mistake a pace pulse for a QRS and fail to alarm in the case of asystole. It is important that the patient category is set correctly so the ECG can be analyzed correctly and initial arrhythmia alarm limits set. A Check Patient ID INOP will appear when a mismatch has not been resolved. As long as patient mismatch has not been resolved, data integration in the Information Center and the own patient overview functionality might not work as equipment is not assigned correctly to the patient. PIIC When a monitor is connected to an Information Center by the wireless IntelliVue Instrument Telemetry interface, the patient data will automatically be merged in the case of a transfer. This means there is no patient discharge at the monitor and settings and trend data will be retained. You will see a message on the monitor and the Patient Demographics window will automatically appear so that you can check the data and change it if necessary. 93 5 Managing Patients and Equipment Manually Resolving Patient Mismatch The source of the patient mismatch is indicated by question marks (???) and displayed in the status line at the bottom of the screen (Patient ???, Patient Category ??? or Paced Mode ???). The Select Patient window automatically opens so you can decide which patient data to use. You do not have to resolve the mismatch immediately, but the indicators remain until you do. After 5 minutes a Check Patient ID INOP will appear to remind you to resolve the mismatch. For some common mismatch situations, the monitor will simplify the resolution by suggesting a solution for the mismatch. For example, when a patient arrives after transport and the Transfer key has been selected, the monitor will show this patient's data and ask Complete transfer of this patient?. You can then select Yes to complete the transfer. If you select No you will go to the Select Patient window. After you resolve the mismatch, the monitor displays a confirmation window that shows the patient that has been selected and where data will be erased, if applicable. Confirm your choice. The monitor automatically displays the Patient Demographics window after confirmation. Verify that the settings shown are correct for the patient. Gender, date of birth, height, weight, and nursing notes do not generate a mismatch. If these fields are different on different devices, the monitor resolves them itself. For example, it may take date of birth from the Information Center, whilst taking gender from the monitor. Always check the patient demographics after combining patients, to ensure that you are satisfied with the results. Change them if necessary. WARNING After resolving a patient mismatch, check that the monitor settings (especially patient category, paced status and alarm limits) are correct for the patient. Patient Mismatch - If One Set of Patient Data is Correct If there is a mismatch between an Information Center and a monitor, choose the data set you want to continue using for this patient by selecting one of the sectors in the Select Patient window. After you resolve the mismatch, the monitor displays a confirmation window that shows the patient that has been selected and where data will be erased, if applicable. Confirm your choice. The monitor automatically displays the Patient Demographics window after confirmation. Verify that the settings shown are correct for the patient. 94 5 Managing Patients and Equipment Patient Mismatch - If Neither Patient Data Set is Correct A patient mismatch where neither set of patient data is correct might occur if you connect a new MMS to a monitor in order to prepare for a new patient, before you actually start measuring. Select New Patient if you are sure that none of the information is correct. This uses the bed, monitor and MMS for a new patient, erases all data in both the monitor and MMS, resets all settings to the default Profile, and lets you admit a new patient. Managing Equipment Multiple pieces of monitoring equipment can be used for a patient. The association between a patient and a device can be made by:
identifying the patient at the device (by entering patient data or using Find Patient to get patient data)
"adding" equipment for an existing patient The association between a patient and a device can be ended by:
discharging the patient, or selecting End Case.
"removing" the device from the patient. transferring the patient without the device. admitting a new patient to the device. automatic freeing of the device. WARNING In all cases listed above, when equipment is freed, all patient identification and measurement data are deleted, all settings are reset to the defaults, and monitoring at the Information Center (if active) is stopped. Any associated devices, e.g. multi measurement modules connected to a monitor, or cableless measurement devices assigned to a monitor, may also be freed, depending on the configuration. Adding Equipment (PIIC iX) By selecting the Add Equipm. key you can display a list of all free equipment (not currently assigned to a patient) and select a device for use with this patient. If you add another monitor, you need to confirm this at the selected monitor. For information on combining equipment when connected to a PIIC, see Using a Telemetry Device and a Monitor on page 215. Removing Equipment The association between a monitor and the patient can be ended by selecting Remove Monitor. With PIIC iX, the Remove Monitor key is not available when the monitor is locked to a bed. Other equipment such as telemetry devices or IntelliVue Cableless Measurements can be removed by selecting the device then selecting Remove in the menu displayed. 95 5 Managing Patients and Equipment Equipment Status Disputes Equipment can come into situations where its status does not match its location. There are three typical situations where this may occur:
PIIC iX only - equipment is locked to a bed, but has been removed and used at another bed. PIIC iX only - equipment has been configured for use in a specific unit, but is now being used in a different unit. Equipment has an equipment label but has not been configured at the Information Center and therefore cannot be managed. If a monitor or a companion device is in one of these situations, a Check Equipment INOP will appear and the equipment status will be shown in the Equipment window. The following symbols (in red) are used to show the status in the Equipment window:
equipment is locked to another bed equipment is not configured for use in this unit equipment label is not in system configuration, or duplicate equipment labels Using the Equipment Window In the Equipment window you have access to patient management, workflow functions (set location, transfer), equipment management functions (add/remove equipment) and caregiver-related functions. You can open the Equipment window directly in Main Setup or by selecting the bed label in the information line. This bed is Bed 8, the connection to the Information Center is active. 1 2 Caregiver area - depending on your network connection, the name of assigned caregiver may be shown. Patient name, category and paced mode. 3 4 This monitor is assigned to the patient and is the one on which you are viewing the window. 96 5 Managing Patients and Equipment The top part of the window contains the patient data, with the assigned caregiver and the status of the connection to the Information Center, and the bed label. In the lower part of the window, all equipment for this patient is shown, with the corresponding assignments and connections. The device you are currently viewing the window on is shown with a dark background (in the above example, the monitor with the label wm8). Changing Caregiver Assignment When a caregiver is assigned, the caregiver name may appear next to the caregiver symbol in the Equipment window (depending on your network connection). Whether the name is shown or not, when you select this area of the window, a menu opens offering the following functions:
PIIC iX Select Caregiver - you can select a different caregiver from a list. When a new caregiver is assigned, the patient will be automatically added to that caregiver's Care Group. The availability of the function and the caregiver list depends on the Information Center configuration. My Patients - opens the My Patients window showing all patients in your Care Group. Using the Patient Area The patient name, patient category and paced status are normally shown in the Equipment window. When a patient has been prepared for transfer, the transfer symbol will be shown:
When you select this area in the Equipment window, a menu opens giving access to the Enter Demographics window, the Transfer function (see Transferring Patients on page 91) and the End Case function. Changing the Location Select the Information Center area on the Equipment window. Select the current location from the list. If the monitor is currently assigned to a bed, but the patient is in another department for treatment or a diagnostic procedure, you can show a temporary location for the patient. 1 2 Or alternatively use the Select Location pop-up key. The temporary location is then shown in the Equipment window, on the Standby screen on the monitor, and in the sector at the Information Center. When the patient returns, you can set the location back to the bed number in the same way as described above. When Multiple Equipment is Used for One Patient It is possible to assign additional monitoring equipment and a telemetry device to the same patient, resulting in the information from multiple devices being combined in one sector at the Information Center. The measurement data from the other devices will be displayed on the monitor screen in the own patient overview window. 97 5 Managing Patients and Equipment WARNING When new equipment has been added for a patient, you will be asked to confirm that the device be used for the patient. Always do this as soon as possible to avoid patient data mismatch. If multiple equipment is assigned to the patient, resolving a patient mismatch at the monitor may resolve other pending patient mismatches or remove other associated equipment. Own Patient Overview Window The measurements from other monitoring devices and telemetry devices are shown combined in the own patient overview window on the monitor, together with related information derived by the Information Center, such as alarms. 1 Current alarm and INOP generated by another device. 2 Own patient overview window 3 Delayed - indication that data in the window is delayed. WARNING All data presented in the own patient overview window are delayed for several seconds. If you need realtime data, for example for defibrillation, always use the host monitor ECG instead of telemetry or ECG from another monitoring device. As long as the ECG is being measured with another device there will be no ECG signal available at the ECG analog output. Visual Alarm Status Information in the Own Patient Overview Window If individual measurement alarms are switched off at any of the devices in use for the patient, an alarms off symbol on a white background is shown beside the measurement numeric 98 5 Managing Patients and Equipment If all alarms are switched off or paused for one of the devices in use for the patient, an alarms off or alarms paused symbol on a dark gray background is shown beside all affected measurement numerics (if so configured). If all red and yellow alarms are switched off/paused, the symbol is red. If only yellow alarms are switched off/
paused, the symbol is yellow. Assigning a Telemetry Transceiver with an SRR Adapter to a Monitor A telemetry device with a short range radio adapter can be assigned to a monitor directly. Monitors which have this capability have a short range radio symbol on the model label. NOTE If the monitor is using the MBAN frequency band (2.360 - 2.400 GHz, for US / FCC regulated countries only), direct assignment of a telemetry device is not possible. If problems occur with the direct assignment, contact your service personnel to check the frequency band used. To assign a telemetry device to a monitor:
1 Press the Check button on the telemetry device. The measurement selection key on the monitor will change to show the "add cableless" symbol The ECG wave appears on the monitor Select the symbol. In the Add Cableless window, select the correct equipment label for the telemetry device. 2 3 4 Check that the assignment is successful and that transmission has begun:
A Tele Device assigned message appears on the monitor A tone sounds at the telemetry device and the Leads Off indicators light To confirm that the correct telemetry device has been assigned, open the ECG Setup menu. The title of the menu contains the equipment label of the telemetry device; check that this is the correct label. If a telemetry device is already assigned to a monitor, you cannot assign a further telemetry device to that monitor. If the telemetry device goes out-of-range or loses the short range radio connection, it will switch over to standard telemetry transmission to the Information Center. In this case, the telemetry data is displayed in the Own Patient Overview Window as described above. When a telemetry device with a short range radio adapter is assigned to the patient, the short range radio connection to the monitor is made automatically. If a telemetry device disappears from the list in the Add Cableless menu, press the Check button on the telemetry device again. If the monitor is not configured to be used with a telemetry device, the add cableless symbol will appear crossed out If the telemetry device is removed (unassigned), the short range radio connection will be ended. WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices and DECT phones. Outside the operating frequency band and 5% above and below, i.e. the exclusion band according IEC 60601-1-2, section 99 5 Managing Patients and Equipment 36.202.3a)4), the short range radio connection is immune up to 3V/m in the frequency range from 80 MHz to 2.0 GHz and up to 1V/m in the frequency range from 2.0 to 2.3 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a Tele Disconnected INOP. Correct channel configuration is important, refer to the Configuration Guide for details. If a Tele Disconnected INOP occurs when the telemetry device goes out-of-range, the INOP will disappear (without being silenced) as soon as the ECG signal from the telemetry device is available at the Information Center via standard telemetry transmission. Controlling Other Devices from the Bedside Select the own patient overview window. Select the Setup Equipm. pop-up key. You can change ECG settings for the current ECG source from the patient monitor. 1 2 A setup menu will appear with the settings available for the current ECG source. If it is a telemetry transmitter or patient monitor connected to the Information Center via LAN or WLAN, the following settings are available: adjust HR alarms, relearn arrhythmia, select primary/secondary ECG lead, select arrhythmia analysis mode, change primary/secondary ECG lead size. PIIC iX only: if the current ECG source is a patient monitor connected to the Information Center via IntelliVue Instrument Telemetry
(IIT), only the adjust HR alarms setting is available. Viewing and Silencing Other Device Alarms at the Bedside When other devices are assigned to the patient, alarms from those devices will also be indicated on the monitor, in addition to the main indication at the Information Center. If configured, a generic alarm message will appear in the alarm status area with standard alarm tones. The alarm message will have the color and * or ! coding corresponding to the severity of the alarm. The specific alarm message (for example ** HR Low) will appear in the own patient overview window. If configured, alarms generated from another device can be silenced at the bedside. Either the monitor Silence key is configured to silence both monitor and other device alarms (must be configured at the Information Center) or the Silence Bed pop-up key will be available:
1 2 Depending on your Information Center configuration, the Silence Bed key may silence both other device alarms and bedside alarms. Select the own patient overview window. Select the Silence Bed pop-up key. WARNING Even when the other device data is not visible on the screen, you may be silencing monitor alarms and other device alarms, if the Information Center and monitor are so configured. 100 5 Managing Patients and Equipment Switching Off or Pausing Alarms From Other Devices When you select Pause Alarms or Alarms Off at the monitor, the alarms are off or paused for the bedside measurements. When you switch alarms off or pause alarms at the Information Center, both monitor alarms and alarms from other assigned devices are affected. Refer to the Information Center Instructions for Use for more details on the Suspend/Pause alarms behavior of the Information Center. Using Standby When you select Standby mode at the monitor, the bedside goes into Standby mode but other assigned devices may continue monitoring. Refer to the Information Center Instructions for Use for details on how selecting Standby at the Information Center affects the monitor and other devices. ECG Source Tracking at the Information Center The Information Center continuously checks whether a valid ECG signal is coming from the monitor or from another assigned device. If you unplug the ECG patient cable from the monitor and plug it into another device, the Information Center will automatically switch to monitoring the ECG from the other device. At the monitor, its own ECG measurement will be deactivated and the Setup ECG menu will no longer be accessible. When you unplug the patient cable from the other device and plug it back into the monitor again, the Information Center will switch back to monitoring the ECG from the monitor. The ECG measurement will be activated again at the monitor. [Note that in this case, as the screen switches back to the monitor's own measurements, the SpO2T measurement (if present) will no longer be displayed]. In the same way the source is tracked when a telemetry device is directly connected to a monitor, then disconnected and vice versa. In case of ambiguity, a yellow INOP message !!Check ECG Source indicates that more than one valid ECG source is active. Synchronized Settings For some measurements, settings can be synchronized between the monitor and another measurement device. For example, if ECG is measured at the monitor, and then the patient is connected to a telemetry device for monitoring, the Information Center will use the monitor settings for the telemetry device. In general, the following settings will be synchronized:
Heart Rate ECG Arrhythmia HR/Pulse Alarm On/Off, Heart Rate High/Low Limit ECG On/Off1, Primary Lead, Secondary Lead, Va Lead, Vb Lead, Lead Placement Analysis Mode, Arrhythmia On/Off, Asystole Threshold, Pause Threshold, VTach HR, VTach Run, PVCs/min, Vent. Rhythm, SVT HR, SVT Run, PVCs/min On/Off, Pacer not capture On/Off, Pacer not pace On/Off, Non-Sustain On/Off, Vent. Rhythm On/Off, Run PVCs On/Off, Pair PVCs On/Off, Missed Beat On/Off, Pause On/Off, R-on-T PVCs On/
Off, Vent. Bigeminy On/Off, Vent. Trigeminy On/Off, Multiform PVCs On/Off, Irregular HR On/Off, SVT On/Off, Afib On/Off, Afib/IrrHR End Threshold, All ECG Alarm INOP mode. 101 5 Managing Patients and Equipment ST QT SpO2T ST Analysis On/Off, ST Alarm On/Off, ISO Point, J point, ST point, ST Alarm Limits, ST-Index On/Off, ISO/J-Point Detection, ST Lead On/
Off, ST Baseline QT analysis On/Off, QT Lead, QTc High Alarm On/Off, QTc Alarm On/Off, QTc High Limit, QTc High Limit, QT Baseline2 SpO2 Alarms on/off, SpO2 Alarm limits, SpO2 Low Alarm Delay, SpO2 High Alarm Limit, Desat Alarm Limit NBP Alarm Suppression On/Off, Pulse(SpO2) On/Off 1ECG On/Off setting is forced to ON by the monitor, if the local setting is ON. 2With PIIC, QT baseline is synchronized, but not QT snippets. PIIC iX With the IntelliVue Information Center iX, the following additional measurement settings can be synchronized:
ECG/Arrhythmia ST NBP Resp SpO2 Some ECG Alarms INOP On/Off, Hexad Reconstruction Mode STE On/Off, STE Alarm On/Off Sys/Dia/Mean Alarm Limits, Alarms On/ Off, Alarm Source Apnea Time, Alarm Limits, Alarm On/Off, Resp On/Off SpO2 Alarms on/off, SpO2 Alarm limits, Desat Alarm Limit, NBP Alarm Suppression On/Off, Pulse(SpO2) On/Off, Measurement Mode1, Repetition Time1 1Measurement Mode and Repetition Time can only be synchronized if SpO2 comes from a Cableless SpO2 Pod or a telemetry device. WARNING Not all settings are synchronized; after changing the measurement source, always check that the settings are appropriate. If later the patient is disconnected from the other device, and reconnected to the monitor again, any changes in the settings made in the meantime will be passed on to the monitor. In this way, settings continuity is preserved when the measurement source changes. NOTE Settings synchronization can be switched off at the monitor in Configuration mode. In certain situations, you will be asked to confirm that synchronization of settings is appropriate. Settings synchronization can only take place when there is no patient information mismatch between the monitor and the Information Center. PIIC If a Check ECG Settings or !! Check Pairing INOP appears always check that the ECG settings, especially the paced setting, are appropriate for your patient. PIIC iX If a Check ECG Settings, Chk SpOT Settings, or another check settings INOP appears, always check that the settings, especially the paced setting for ECG, are appropriate for your patient. 102 Information Center Compatibility 5 Managing Patients and Equipment The functionality available for managing patients and equipment depends on the IntelliVue Information Center being used. In the following table the main differences between the PIIC and PIIC iX are shown. PIIC Not available Transfer Patient - patient is moved to transfer list. Not available Add Equipment - allows only assignment of telemetry devices via manual pairing. Remove equipment - allows only removal of telemetry devices via Unpair To Mon. and Unpair To Tele. Not available Not available Not available PIIC iX Find Patient - searching for a patient in the Information Center or other connected hospital systems. (With LAN and WLAN connection only) Transfer Patient - can transfer patient directly to another bed/unit and from another bed/unit. (With LAN and WLAN connection only) A unique patient list provides information about the current status of a patient allowing intelligent prompts and preventing the same patient being admitted twice. Add Equipment - allows assignment of other monitors, telemetry devices and X2 MMS. (With LAN and WLAN connection only) Remove equipment - allows removal of other monitors, telemetry devices and X2 MMS. Select Location - allows a temporary location to be shown when a patient is not in the unit. (With LAN and WLAN connection only) Select Caregiver - allows a Caregiver to be assigned to a patient Paced status Unconfirmed is the initial setting before a paced status has been entered. Unconfirmed will switch pace pulse rejection on but makes the user aware that no paced status has been selected. 103 5 Managing Patients and Equipment 104 6 6ECG, Arrhythmia, ST and QT Monitoring The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as a waveform and a numeric. This section also tells you about arrhythmia monitoring (see About Arrhythmia Monitoring on page 129), ST monitoring (see About ST Monitoring on page 139) and QT monitoring (see About QT/QTc Interval Monitoring on page 152). Skin Preparation for Electrode Placement Good electrode-to-skin contact is important for a good, noise-free ECG signal, as the skin is a poor conductor of electricity. 1 2 Clip or shave hair from sites as necessary. 3 Wash sites thoroughly with soap and water, leaving no soap residue. Select sites with intact skin, without impairment of any kind. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance. 4 Dry skin thoroughly. Connecting ECG Cables 1 Attach the clips or snaps to the electrodes before placing them. If you are not using pre-gelled electrodes, apply electrode gel to the electrodes before placement. Place the electrodes on the patient according to the lead placement you have chosen. 2 3 Attach the electrode cable to the patient cable. 4 Plug the patient cable into the white ECG connector. An ECG waveform and numeric appears on the monitor display. CAUTION To protect the monitor from damage during defibrillation, for accurate ECG information and to protect against noise and other interference, use only ECG electrodes and cables specified by Philips. Some non-authorized electrodes may be subject to large offset potentials due to polarization. 105 6 ECG, Arrhythmia, ST and QT Monitoring Selecting the Primary and Secondary ECG Leads The monitor uses the primary and secondary lead to compute HR and to analyze and detect cardiac arrhythmias. They are also available for recordings and for display on the Information Center. The secondary lead is only used if your monitor is configured for multi-lead (instead of single-lead) arrhythmia analysis. You should choose a lead as primary or secondary lead that has the following characteristics:
the QRS complex should be either completely above or below the baseline and it should not be bi-phasic the QRS complex should be tall and narrow the P-waves and T-waves should be less than 0.2 mV To select a lead as primary or secondary lead:
In the Setup ECG menu, select Primary or Secondary, then select the appropriate lead. You can assign any available lead whether it is currently displayed or not. Checking Paced Mode It is important to set the paced mode correctly when you start monitoring ECG. To change the paced mode in the Setup ECG menu, select Paced Mode to switch between On, Off or Unconfirm. WARNING Pace pulse rejection must be switched on for paced patients by setting Paced Mode to On. Switching pace pulse rejection off for paced patients may result in pace pulses being counted as regular QRS complexes, which could prevent an asystole event from being detected. When changing profiles, and at admission/discharge, always check that paced mode is correct for the patient. Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Make sure that pace pulses are detected correctly by checking the pace pulse markers on the display. Keep pacemaker patients under close observation. 106 6 ECG, Arrhythmia, ST and QT Monitoring Understanding the ECG Display Your display may be configured to look slightly different. Lead label of the displayed wave 1 2 ECG Filter label 3 1 mV calibration bar 4 Pacer spikes 5 Pace pulse markers 6 Current heart rate 7 Current heart rate alarm limits and paced mode symbol 8 EASI or Hexad lead placement label ECG HR numeric: This is the heart rate derived from the monitored ECG. Pace pulse markers: These are shown if the Paced Mode status has been set to On, the pacer spikes are not configured to have a fixed size, and the patient has a paced signal. Pacer Spikes: The pacer spikes are shown in white, unless the ECG wave is white, then they will be green. If the pacer spikes have been configured to have a fixed size, they will be displayed in the background as a dotted line. 1 Pacer spikes configured to have a fixed size Synchronization pulse marks: When a cable is connected to the ECG sync pulse output connector, and the synchronization pulse is configured to be shown, the synchronization marks appear as vertical lines on the ECG wave. The synchronization marks will be shown in yellow, unless the ECG wave is yellow, then they will be green. 1 Synchronization marks in yellow ST numerics in ECG wave: ST numerics can be configured to show underneath the ECG wave on the left side. Hexad lead placement label: When 6-lead placement for a Hexad derived 12-lead ECG is used, the Hexad lead placement label is displayed and all derived leads are marked with a "d" in front of the lead label, for example dV1. 107 6 ECG, Arrhythmia, ST and QT Monitoring Monitoring Paced Patients An ECG optimized for monitoring a paced patient should look like this:
1 Normal Beats 2 Pace Pulses/Pace Beats You should choose a lead as primary or secondary lead that has these characteristics:
the normal QRS complex should be either completely above or below the baseline and it should not be bi-phasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses. the QRS complex should be tall and narrow the P-waves and the T-waves should be less than 0.2 mV. For ease of identification on the screen, the pacer spikes can be configured to have a fixed size. They are then shown in the background as dotted lines. The length of the dotted line is fixed to the wave channel height and is independent of the actual pacer amplitude. Setting the Paced Status In the Setup ECG menu, select Paced Mode to switch between On, Off or Unconfirm. You can also change the paced mode in the Patient Demographics window. When Paced Mode is set to On:
Paced Mode On Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as extra QRS complexes. pace pulse marks are shown on the ECG wave as a small dash (only when the pacer spikes are not configured to have a fixed size). the paced symbol is displayed under the HR label. When Paced Mode is set to Off, pacer spikes are not shown in the ECG wave. Be aware that switching pace pulse rejection off for paced patients may result in pace pulses being counted as regular QRS complexes, which could prevent an asystole event from being detected. When the paced mode has not yet been set for a patient, the paced symbol will have a question mark indicating the Unconfirm mode. When the paced mode is Unconfirm, pace pulse rejection is switched on. 108 Paced Mode Off Paced Mode Unconfirmed 6 ECG, Arrhythmia, ST and QT Monitoring Avoiding Pace Pulse Repolarization Tails Some unipolar pacemakers display pace pulses with repolarization tails. These tails may be counted as QRSs in the event of cardiac arrest or other arrhythmias. If you note a visible repolarization tail, choose a lead that decreases the size of the repolarization tail. 1 Repolarization tail (note width) Changing the Size of the ECG Wave If any of the displayed ECG waves is too small or clipped, you can change the size of one or all of the ECG waves on the screen. Changing the adjustment factor only changes the visual appearance of the ECG wave on the screen. It does not affect the ECG signal analyzed by the monitor. Comparing the wave size to the 1 mV calibration bar on the ECG wave segment can help you to get an idea of the true ECG signal strength. If you choose a fixed adjustment factor, the 1 mV calibration bar will be the same size for all the displayed ECG waves. If you choose Auto Size, or an individual size using the Size Up/Size Down keys, the calibration bar may be a different size for each wave. To Change the Size of an Individual ECG Wave 1 2 Select the wave segment you want to change. This calls up the lead menu for this segment. In the lead menu, select Size Up to increase wave size or Size Down to decrease the size. Selecting Auto Size lets the monitor choose the optimal adjustment factor for all available ECG waves. To Change the Size of all the ECG Waves To change the size of all the ECG waves on the screen by a fixed adjustment factor, 1 2 In the Setup ECG menu, select Adjust Size. Select the required adjustment factor from the line of pop-up keys. Size x0.5 to halve the wave size Size x1 to display the wave without zoom Size x2 to double the wave size Size x4 to multiply the wave size by four 109 6 ECG, Arrhythmia, ST and QT Monitoring Changing the Volume of the QRS Tone The QRS tone is derived from either the HR or Pulse, depending on which is currently selected as the alarm source. The QRS volume can be set from 0 to 10 (0 means off). To change the QRS volume, in the Setup ECG menu select QRS Volume and then select the appropriate volume from the pop-up list. Changing the ECG Filter Settings The ECG filter setting defines how ECG waves are smoothed. An abbreviation indicating the filter type is shown underneath the lead label on the monitor display. Filter settings do not affect ST measurement. To change the filter setting, in the Setup ECG menu, select Filter and then select the appropriate setting. Monitor: Use under normal measurement conditions. Ext. Monitor: Use when diagnostic quality is required but low frequency interference or a wandering baseline may be expected. The upper edge frequency is the same as the Diag setting and the lower edge frequency is the same as the Monitor setting. Filter: The filter reduces interference to the signal. It should be used if the signal is distorted by high frequency or low frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low frequency interference usually leads to a wandering or rough baseline. In the operating room, the Filter reduces artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting Filter may suppress the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor. This does not affect the ECG analysis performed by the monitor. If AutoFilter is set to On in Configuration Mode, the filter setting will automatically be set to Filter if electromagnetic interference is detected. Diag: Use when diagnostic quality is required. The unfiltered ECG wave is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segments are visible. The setting Diag selects the highest available ECG bandwidth which is 0.05 to 150 Hz for the Adult, Pedi and Neo patient category. The term "diagnostic" relates only to the ECG bandwidth requirements for diagnostic electrocardiographic devices as outlined in the ANSI/
AAMI standard EC11-1991. When you are using a telemetry transmitter connected via short range radio to the monitor, the upper bandwidth for all filter settings is limited to 40 Hz. Choosing EASI or Standard Lead Placement In the Setup ECG menu, select Placement and then Standard or EASI. You must enable either standard lead placement or EASI lead placement. EASI is shown beside the 1mV calibration bar on the ECG wave on the display, and EASI is marked on any printouts. See the section on EASI ECG Lead Placement on page 122 for electrode placement diagrams. 110 6 ECG, Arrhythmia, ST and QT Monitoring Selecting Positions of Va and Vb Chest Leads (for 6-lead placement) 6-lead Placement The two chest leads for the 6-lead placement can be positioned at any two of the V1 to V9 and V3R to V6R positions. Select the positions you have used in the Setup ECG menu, so that the chest leads will be correctly labeled. 1 2 3 In the Setup ECG menu, select Va Lead. Select the position used from the list. Select Vb Lead and select the position used from the list. 6-Lead Placement for Hexad Derived 12-lead The Hexad ECG lead system uses a 6-lead set connected to four limb electrodes (using Mason-Likar placement) and two chest electrodes. The algorithm derives the four remaining V-leads to provide a non-diagnostic 12-lead view, including ECG waves and ST/QT measurements. The two chest leads for the 6-lead placement for Hexad must be positioned at two of the V1 to V6 positions. The following combinations of positions can be used:
V1 and V3 V1 and V4 V1 and V5 V2 and V4 V2 and V5 V3 and V5 V3 and V6 Select the two leads you have used in the Setup ECG menu:
1 In the Setup ECG menu, select Hexad (Va,Vb). 2 Select the correct combination of V-lead positions from the list. Making the selection switches the Hexad derived 12-lead ECG on. The Hexad derived 12-lead ECG is intended for use with adult patients only. For this reason, the Hexad (Va,Vb) selection will not be available in neonatal and pediatric modes. About ECG Leads To make it possible to compare measured ECG signals, the electrodes (or lead sets) are placed in standardized positions, forming so-called "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different lead sets in varying lead placements can be used. You can use either standard lead placements or EASI lead placements with this monitor. When placing electrodes, choose a flat, non-muscular site where the signal will not be interfered with by either movement or bones. Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close to the heart, QRS morphology can be greatly altered if an electrode is moved away from its correct location. 111 6 ECG, Arrhythmia, ST and QT Monitoring ECG Leads Monitored If you are using a 3-electrode set a 5-electrode set a 6-electrode set a 6-electrode set with the Hexad algorithm a 10-electrode set an EASI 5-electrode set these leads are available:
I, II, III I, II, III, aVR, aVL, aVF, V, MCL, Va I, II, III, aVR, aVL, aVF, Va, Vb I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Two V leads are directly measured and four are derived. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Changing Lead Sets To change the ECG lead set, When adding leads: place the additional electrodes as required - the monitor automatically recognizes the new lead placement. When removing leads: there are two possibilities - removing the complete chest leads block or removing individual leads. If you unplug the chest lead block from the trunk cable connector, the monitor will automatically recognize the new lead placement. Remove individual leads by removing the electrodes. The monitor will issue a Lead Off INOP message; select New Lead Setup in the Setup ECG menu and the INOP message will disappear. ECG Lead Fallback If fallback is configured on and there is a leads off INOP in the primary lead (and in the secondary lead, if you are using multi-lead monitoring) for longer than 10 seconds, and if another lead is available, this available lead automatically becomes the primary lead. This is known as lead fallback. When the Leads Off condition is corrected, the leads are automatically switched back. This setting can only be changed in Configuration Mode. ECG Lead Placements The labels and colors of the ECG electrodes differ according to the standards that apply for your hospital. The electrode placement illustrations in this chapter use the AAMI labels and colors. EASI I S A N E Electrode labels AAMI RA LA LL RL V V1/Va V2/Vb V3 IEC R L F N C C1/Ca C2/Cb C3 Electrode colors AAMI White Black Red Green Brown Brown/Red Brown/Yellow Brown/Green IEC Red Yellow Green Black White White/Red White/Yellow White/Green 112 6 ECG, Arrhythmia, ST and QT Monitoring EASI Electrode labels AAMI V4 V5 V6 IEC C4 C5 C6 Electrode colors AAMI Brown/Blue Brown/Orange Brown/Violet IEC White/Brown White/Black White/Violet Standard 3-Lead Placement 1 RA placement: directly below the clavicle and near the right shoulder LA placement: directly below the clavicle and near the left shoulder LL placement: on the left lower abdomen 2 3 Standard 5-Lead Placement 1 RA placement: directly below the clavicle and near the right shoulder LA placement: directly below the clavicle and near the left shoulder 2 3 RL placement: on the right lower abdomen 4 LL placement: on the left lower abdomen 5 V placement: on the chest, the position depends on your required lead selection. If configured, the label of the chest lead will be displayed with its exact position (V1 to V6R) 113 6 ECG, Arrhythmia, ST and QT Monitoring Standard 6-Lead Placement Use the positions from the 5-lead diagram above but with two chest leads. The two chest leads, Va and Vb, can be positioned at any two of the V1 to V9 or V3R to V6R positions shown in the chest electrode diagram below (see Chest Electrode Placement on page 115). The Va and Vb lead positions chosen must be selected in the Setup ECG Menu. Hexad 6-Lead Placement Use the positions from the 5-lead diagram above but with two chest leads. For Hexad derived 12-lead, the two chest leads, Va and Vb, must be positioned at two of the V1 to V6 positions shown in the chest electrode diagram below (see Chest Electrode Placement on page 115). The following combinations of positions can be used:
V1 and V3 V1 and V4 V1 and V5 V2 and V4 V2 and V5 V3 and V5 V3 and V6 The Va and Vb lead positions chosen must be selected in the Setup ECG Menu. When Hexad lead placement is selected, Hexad is shown beside the 1 mV calibration bar on the ECG wave and all derived leads are marked with a "d" in front of the lead label, for example dV1. WARNING Hexad derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. They should not be used for diagnostic interpretations. 114 Chest Electrode Placement A - Angle of Louis 6 ECG, Arrhythmia, ST and QT Monitoring V1 on the fourth intercostal space at the right sternal border V2 on the fourth intercostal space at the left sternal border V3 midway between the V2 and V4 electrode positions V4 on the fifth intercostal space at the left midclavicular line V5 on the left anterior axillary line, horizontal with the V4 electrode position V6 on the left midaxillary line, horizontal with the V4 electrode position V3R -V6R on the right side of the chest in positions corresponding to those on the left VE over the xiphoid process V7 on posterior chest at the left posterior axillary line in the fifth intercostal space V7R on posterior chest at the right posterior axillary line in the fifth intercostal space V8 posterior lead, level with V7 at the left midscapular line V9 posterior lead, level with V7 at the left spinal border. For accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space. 1 Locate the second intercostal space by first palpating the Angle of Louis (the little bony protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space just below this is the second intercostal space. Palpate and count down the chest until you locate the fourth intercostal space. 2 10-Lead Placement When monitoring 12-leads of ECG, using a 10-Electrode Lead Placement, it is important to correctly place electrodes and to label all 12-lead ECG reports with the correct lead placement. 115 6 ECG, Arrhythmia, ST and QT Monitoring Conventional 12-Lead ECG 1 V1 - V6 2 LA 3 RA 4 RL 5 LL In conventional 12-Lead ECG using 10 electrodes, an electrode is placed on the right arm, left arm, right leg, and left leg. Six V- electrodes are placed on the chest. The right leg electrode is the reference electrode. Limb electrodes:
Place arm electrodes on the inside of each arm, between the wrist and the elbow. Place leg electrodes inside of each calf, between the knee and the ankle. Chest electrodes:
V1 - on the 4th intercostal space at the right sternal border V2 - on the 4th intercostal space at the left sternal border V3 - midway between the V2 and V4 electrode positions V4 - on the 5th intercostal space at the left midclavicular line V5 - on the left anterior axillary line, horizontal with the V4 electrode position V6 - on the left midaxillary line, horizontal with the V4 electrode position 116 Modified 12-Lead ECG 6 ECG, Arrhythmia, ST and QT Monitoring LA 1 2 V1-V6 3 LL 4 RL 5 RA 6 Angle of Louis If your institution uses modified 10-lead ECG electrode placement (the Mason-Likar Lead System), place the four limb electrodes close to the shoulders and lower abdomen. The six V electrodes are placed on the chest in the same position as the conventional 12-lead placement. Choosing Standard or Modified Electrode Placement WARNING Do not use ECG analysis interpretation statements and measurements for 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. This may lead to misdiagnosis since the modified (Mason-Likar) limb electrode placement does not look the same as the conventional 12-lead ECG and may mask inferior infarction due to calculated axis, R, P and T wave magnitudes shifts and ST slope. Do not export 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. Captured 12-Lead ECGs using the modified (Mason-Likar) limb electrode placement exported from the Information Center are not annotated with the Mason-Likar label. If your institution uses modified 10 Lead ECG electrode placement (the Mason-Likar Lead System), you must set Limb Leads to on Trunk in the monitor. To do this, in the Setup ECG menu, select Limb Leads then select on Trunk. When Limb Leads is set to on Trunk, 12 Lead ECG Reports will be labeled 12 Lead ECG Report
(Mason-Likar), and captured 12-lead ECGs will be labeled Mason-Likar to the right of the bandwidth annotation at the Information Center. When Limb Leads is set to on Limbs, 12 Lead ECG Reports will be labeled 12 Lead ECG Report
(Standard), and captured 12-lead ECGs will not be annotated at the Information Center. 117 6 ECG, Arrhythmia, ST and QT Monitoring WARNING Do not use ECG analysis interpretation statements and measurements for 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. This may lead to misdiagnosis since the modified (Mason-Likar) limb electrode placement does not look the same as the conventional 12-lead ECG and may mask inferior infarction due to calculated axis, R, P and T wave magnitudes shifts and ST slope. Do not export 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. Captured 12-Lead ECGs using the modified (Mason-Likar) limb electrode placement exported from the Information Center are not annotated with the Mason-Likar label. WARNING Do not use ECG analysis interpretation statements and measurements for 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. This may lead to misdiagnosis since the modified (Mason-Likar) limb electrode placement does not look the same as the conventional 12-lead ECG and may mask inferior infarction due to calculated axis, R, P and T wave magnitudes shifts and ST slope. Do not export 12-lead ECGs obtained using the modified (Mason-Likar) limb electrode placement. Captured 12-Lead ECGs using the modified (Mason-Likar) limb electrode placement exported from the Information Center are not annotated with the Mason-Likar label. Capture 12-Lead You can view a 12-Lead ECG on the screen, capture a 12-Lead ECG episode, preview the captured ECG data and then store it and send it to a connected Information Center for analysis. You can download the resulting analysis from the Information Center and also other 12-Lead captures for review at the monitor. A 12-Lead report can be printed that also includes the downloaded analysis results and an ST Map. You can operate the 12-Lead Export function and the 12-Lead Lock/Unlock function at the Information Center remotely from the monitor. The monitor can store one 12-Lead ECG episode at any time. Viewing the Realtime 12-Lead ECG Select the Capture 12 Lead SmartKey, or Select the Main Setup SmartKey then select Capture 12 Lead. To open the 12-Lead ECG window and view the realtime ECG waves, If a previously viewed 12-Lead ECG was not stored, a window will pop up asking whether you want to keep it or not. The title bar of the window shows the date and time when this 12-Lead ECG was captured. If you do not need the ECG, select No to discard it, otherwise, select Yes and then select Store & Send to store that 12-Lead ECG and send it to an Information Center (if one is connected). If your patient is not admitted, you will be prompted to enter at least the age and gender of the patient. This information is needed for analysis of the 12-Lead ECG at the Information Center but is not essential if you only want to capture the 12-Lead ECG without sending it for analysis. To enter this information:
118 6 ECG, Arrhythmia, ST and QT Monitoring Select the Admit Patient pop-up key, then 1 2 Enter the information in the Patient Demographics window. 3 Open the 12-Lead ECG window again as described above. The age and gender will now be displayed in the title bar of the pop-up keys. To change the way the realtime waves are displayed, select the Change View pop-up key or select the wave area. You can switch between a one or two column display. The two column display lets you see a larger representation of the waves. If you are using the Hexad lead placement, you can select the Setup Leads pop-up key to select the positions of the chest leads (Va and Vb or Ca and Cb). While the realtime 12-Lead waves are being viewed in the window, the ECG filter mode (see Changing the ECG Filter Settings on page 110) is changed to the 12-Lead filter setting (see Changing Settings for a Captured 12-Lead ECG on page 119). Capturing the 12-Lead ECG To capture the last 10 seconds of ECG data, select the Capture Waves pop-up key. The pop-up key is active as soon as enough wave data is available; until then a progress bar is displayed in the title bar of the pop-up keys. A preview of the captured data appears on the screen (unless your monitor is connected to an Information Center with software release earlier than Revision M then the captured data is automatically stored and sent to the Information Center). The title bar of the pop-up keys will now show the current filter setting and, if you are using EASI or Hexad lead placement, an EASI or Hexad indicator will appear at the bottom of the captured data. You can at any time return to the realtime 12-Lead ECG view by selecting the Show Waves pop-up key. From there, you return to the preview window by selecting the Review 12 Lead pop-up key and then selecting the 12-Lead marked with * from the list. Changing Settings for a Captured 12-Lead ECG Select the Setup 12 Lead pop-up key to choose settings for filter, gain, etc., if changes are needed. All changes apply to both the display and the printed 12-Lead report. The changes are only applied temporarily and will not be stored. If you want to change the default settings, see Setting Up the 12-
Lead ECG on page 122. High Pass Filter Low Pass Filter AC Filter Gain Chest Gain Paper Speed Limb Leads Sets the high pass filter for the waveforms. Choices are 0.05 Hz, 0.15 Hz and 0.5 Hz. Sets the low pass filter for the waveforms. Choices are 40 Hz, 100 Hz and 150 Hz. Switches the AC (line frequency) filter On or Off. Defines the gain used for the waveforms. Choices are 2.5 mm/mV, 5 mm/mV, 10 mm/mV and 20 mm/mV. Defines the gain for the chest leads relative to the standard gain setting. Choices are Full and Half. Defines the waveform speed. Choices are 25 mm/sec and 50 mm/sec. Sets the position of the limb leads. Choices are on Limbs and on Trunk. 119 6 ECG, Arrhythmia, ST and QT Monitoring Format Time Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Lead Sequence Defines the page layout. Choices are 12x1, 6x2, 3x4, 3x4 1R, 3x4 3R,3x4 ST and 3x4 1R ST. 1R and 3R refer to 1 or 3 rhythm leads, ST formats contain an ST map. Defines whether all leads show simultaneous or sequential intervals of time, when displaying or printing 2 or more columns. Choices are Sequential and Simultaneous. Defines which lead will be used as rhythm lead 1, 2 or 3. Choices are Primary, Secondary, I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V3R, V4R, V5R, V6R, and MCL. This setting is only relevant when 3x4 1R, 3x4 1R ST or 3x4 3R is selected as Format. Defines the sequence in which the leads are presented. Choices are Cabrera and Internat. Storing and Sending the 12-Lead ECG You can assign an order number that will then be associated and stored with the 12-Lead ECG. If you have an Information Center connected, it may provide order management, in which case an Order (xx) pop-up key is displayed. This opens the order window from the Information Center, showing a list of any pending 12-lead orders for the patient. In this window you can assign and remove orders, in the same way as you would do directly at the Information Center. If no Information Center is connected, you can enter an order number manually. Select the Enter Order
# pop-up key and type in the number. The order number will be stored with the capture and displayed in the title bar of the pop-up keys. To store the previewed data on the monitor and send it to a connected Information Center for storage and analysis, select the Store & Send pop-up key. If the monitor is connected to an Information Center, use the Store & Send function before patient transport to store the 12-Lead ECG centrally, as the 12-Lead ECG data will not be uploaded from the MMS to another monitor after transport. If the connection to the Information Center is not active while storing, the 12-Lead ECG will be automatically sent as soon as the connection is established or restored. If a previously stored 12-Lead ECG is waiting to be sent to the Information Center, it will be overwritten when a new 12-Lead ECG is stored and can then not be sent to the Information Center. Printing the 12-Lead ECG Print a dedicated 12-Lead ECG report by selecting the Print Report pop-up key. When you are working with a PIIC iX that provides 12-Lead analysis data to the monitor, the report contains the 12-Lead analysis results as well as measurement values (e.g. ST values, QT values, HR) that are also downloaded from the PIIC iX. If you work with a PIIC, or a PIIC iX without the necessary license, no 12-Lead analysis data is provided to the monitor. In this case, the report only contains the real-time measurement values from the bedside. Consequently, the measurement values in the report might differ in the two cases, due to the slightly different algorithm approaches of the patient monitor (real-time measurement) and the PIIC iX
(diagnostic interpretation of 12-Lead capture). 120 6 ECG, Arrhythmia, ST and QT Monitoring Downloading Analysis Results (PIIC iX only) Download analysis results from the IntelliVue Information Center by selecting Show Analysis. Return to the previous screen by selecting Hide Analysis. Reviewing Previewed or Stored 12-Lead Captures To view 12-Lead captures previewed or stored on the monitor or 12-Lead captures stored at the IntelliVue Information Center (PIIC iX only), select Review 12 Lead. You can then select from a list of 12-Lead captures available for the current patient. The 12-Lead captures in the list may be marked with a symbol, for example an open or closed padlock to indicate unlocked or locked status or a * to indicate preview status. Information Center Remote Export (PIIC iX only) Use the Export key to remotely start the 12-Lead export functionality of the IntelliVue Information Center. Information Center Remote Lock/Unlock (PIIC iX only) Use the Lock key to remotely lock the 12-Lead capture at the IntelliVue Information Center. If it is already locked, the Unlock key will be displayed. Capture 12-Lead Pop-up Keys Here is a summary of all the pop-up keys available during the 12-Lead ECG procedure:
Pop-up Keys Admit Patient Change View Capture Waves Show Waves Setup 12 Lead Order (xx) Enter Order #
Print Report Store & Send Review 12 Lead Show Analysis Export Selecting this pop-up key lets you enter the age and gender for the patient, to allow analysis of the 12-Lead ECG. switch between the single column and two-column display of the realtime wave data. capture the current ECG waves and open the preview window. return to the realtime 12-Lead ECG view. choose settings for filter, gain, display layout, etc. open the order window from the Information Center (if available) and assign order numbers to 12-Lead captures. enter an order number that is stored with the capture and displayed in the title bar of the pop-up keys. print a 12-Lead report. store the captured 12-Lead ECG in the monitor and send it to the Information Center. view a list of 12-Lead captures available at the monitor or at the IntelliVue Information Center, and select one for review. download analysis results from the IntelliVue Information Center. remotely export 12-Lead ECG data from the IntelliVue Information Center to an ECG management system (see the Information Center Instructions for Use for details). 121 6 ECG, Arrhythmia, ST and QT Monitoring Pop-up Keys Lock / Unlock Setup Leads Selecting this pop-up key lets you remotely lock/unlock the 12-Lead capture at the IntelliVue Information Center. switch between Standard and EASI lead placement and select the positions of the chest leads (Va and Vb or Ca and Cb), when using Hexad lead placement. Setting Up the 12-Lead ECG Select the HR numerics on the screen to enter Setup ECG. Select 12Lead. You can make settings that will be stored and used in future as default settings for each 12-Lead ECG capture made. 1 2 3 The Setup 12 Lead window opens for you to make the default settings. For a description of the available settings, see Changing Settings for a Captured 12-Lead ECG on page 119. EASI ECG Lead Placement Using a standard 5-electrode set in EASI lead placement you can monitor up to 12 standard ECG leads simultaneously and continuously at the bedside. EASI provides a monitoring method for trending ST segment changes that can provide an early indication of ischemia. WARNING EASI-derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations. Respiratory monitoring is also possible with the EASI placement; respiration is measured between the I and A electrodes. Place the electrodes as accurately as possible to obtain the best quality EASI measurements. When EASI lead placement is selected, EASI is shown beside the 1 mV calibration bar on the ECG wave on the display, and EASI is marked on any recorder strips and printouts. EASI Monitoring During INOP Conditions If one of the derived EASI leads has an INOP condition (for example, Lead Off), a flat line is displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead (depending on which is available) is displayed with the corresponding lead label. This causes an arrhythmia relearn. 122 EASI Electrode Placement 6 ECG, Arrhythmia, ST and QT Monitoring 1 E (V) - on the lower sternum at the level of the fifth intercostal space 2 A (LL) - on the left midaxillary line at the same level as the E electrode S (LA) - on the upper sternum I (RA) - on the right midaxillary line at the same level as the E electrode 3 4 5 N - reference electrode - can be anywhere, usually below the sixth rib on the right hip ECG and Arrhythmia Alarm Overview The ECG and arrhythmia alarms available depend on which measurements are switched on, and the arrhythmia option enabled for your monitor. Cardiotach alarms are available when HR is on and the active alarm source is ECG, but Arrhythmia is switched off Basic arrhythmia alarms are available when Arrhythmia is switched on Enhanced arrhythmia alarms are available when Arrhythmia is switched on and the Enhanced Arrhythmia option has been enabled for your monitor Alarm Description Arrhythmia Configuration Arrhythmia Off Basic Arrhythmia Enhanced Arrhythmia
*** Asystole
*** Vent Fib/Tach
*** VTach
*** Extreme Tachy
*** Extreme Brady
** HR High No beat detected for a period > the asystole threshold (2.5 to 4.0 seconds) Fibrillatory wave (sinusoidal wave between 2 - 10 Hz) for 4 consecutive seconds A run of consecutive beats labeled as V with run length the V-Tach Run limit and ventricular HR > V-Tach HR limit Heart Rate > the Extreme Tachy limit Heart Rate < the Extreme Brady limit Heart rate > the high HR limit x x x x x x x x x x x x x x
(see note) x x x
(see note) 123 6 ECG, Arrhythmia, ST and QT Monitoring Alarm Description Arrhythmia Configuration
** HR Low Heart rate < the low HR limit x x
(see note) x
(see note) Arrhythmia Off Basic Arrhythmia Enhanced Arrhythmia
** Non-Sustain VT
** Vent Rhythm
** Run PVCs High
** Pair PVCs
** R-on-T PVCs
** Vent Bigeminy
** Vent Trigeminy
** PVCs/min High
** Multiform PVCs
** Pause
** Missed Beat 124 A run of consecutive beats labeled as V with run length < the V-Tach Run Limit and ventricular HR > the V-Tach HR limit A run of consecutive beats labeled as V with run length > the Vent rhythm limit and ventricular HR the V-Tach HR limit A run of > 2 consecutive beats labeled as V with run length < Vent rhythm run limit and ventricular HR V-Tach HR limit Two ventricular beats labeled as V between two beats not labeled as V For HR < 100, a beat labeled as V with R-R interval < 1/3 of the average R-R interval followed by a compensatory pause > 1.25 times the average R-R interval or 2 such beats labeled as V without a compensatory pause occurring within 5 minutes of each other (Note: When HR > 100, 1/3 of the R-R interval is too short for detection) A dominant rhythm of beats labeled as N, V, N, V, N A dominant rhythm of beats labeled as N, N, V, N, N, V, N, N Within 1 minute, the number of beats labeled as V > the PVCs/min limit The occurrence of two differently shaped beats labeled as V within the last 60 beats and each occurring at least twice within the last 300 beats No beat detected for a period > the pause alarm threshold (1.5 to 2.5 seconds) No beat detected for a period > 1.75 times the average R-R interval for HR
< 120, or no beat detected for > 1 second with HR > 120 (Paced mode off) x x x x x x x x x x x x 6 ECG, Arrhythmia, ST and QT Monitoring Alarm Description Arrhythmia Configuration Arrhythmia Off Basic Arrhythmia Enhanced Arrhythmia
** Pacer Not Capt
**Pacer Not Pacing
** SVT
* HR High
* HR Low
* AFIB
* End AFIB
** Irregular HR
* End Irregular HR No beat detected for a period > 1.75 times the average R-R interval and pace pulse(s) detected. (Paced mode on) No beat detected for a period > 1.75 times the average R-R interval and no pace pulse(s) detected (Paced mode on) A run of consecutive beats labeled as S with run length SVT run limit and ventricular HR > SVT HR limit Heart rate > the high HR limit Heart rate < the low HR limit An irregular rhythm of beats labeled as N and variability in P-R intervals and P-wave variability (For adult patient category only) Atrial Fibrillation no longer detected for the Afib end delay time (For adult patient category only) An irregular rhythm of beats labeled as N (irregular R-R intervals changes greater than 12.5%) Irregular HR rhythm no longer detected for the irregular HR end delay time x x x x x x
(see note) x
(see note) x
(see note) x
(see note) x x x x Note: ** HR Low and ** HR High are available only if HR alarms are configured as yellow alarms, and **
HR Low and * HR High are available only if HR alarms are configured as short yellow alarms. Using ECG Alarms ECG alarms can be switched on and off and the high and low alarm limits changed just like other measurement alarms, as described in the Alarms chapter. Special alarm features which apply only to ECG are described here. Extreme Alarm Limits for Heart Rate The extreme rate alarms, extreme tachycardia and extreme bradycardia, are generated by the active alarm source, either HR or Pulse. The difference between the low HR alarm limit and the extreme bradycardia limit is unit configured. For example, if the low alarm limit is 60 bpm and the extreme bradycardia limit difference is configured to be 20 bpm, then the extreme bradycardia limit is 40 bpm. If the difference is configured to be 0, there will always be an extreme bradycardia alarm when the HR falls below the HR low limit. 125 6 ECG, Arrhythmia, ST and QT Monitoring The same is true for the difference between the high HR alarm limit and the extreme tachycardia limit. In the same way, the extreme tachycardia limit is determined by adding a difference to the high HR limit. 1 Extreme Brady Limit 2 Low Limit 3 High Limit 4 Extreme Tachy Limit 5 Extreme Brady 6 Extreme Tachy The difference is set in Configuration Mode. You need to know which value has been configured for your monitor. To see the difference value for the extreme rate alarms on your monitor, in the Setup ECG menu, see the menu items ExtrTachy and ExtrBrady. For safety, the extreme bradycardia and extreme tachycardia limits clamp at a configured value. For example, the extreme bradycardia limit for neonates has a default limit clamp at 70 bpm. Thus if the HR low alarm limit is moved to 80 bpm and the extreme bradycardia limit difference is 20 bpm, the extreme bradycardia limit will be 70 bpm. However, if you move the HR low alarm limit below the clamp to 65 bpm, the extreme bradycardia limit will also be 65 bpm and only the extreme bradycardia alarm will occur if the HR falls below this limit. You can view the current limits for the extreme rate alarms, Extreme Tachy and Extreme Brady, in the measurement's alarm limits window:
1 2 3 The alarm limit window for HR is shown, with the high and low limits and the Extreme Tachy and Extreme Brady limits. Select one of the alarm fields. Select the Alarm Limits pop-up key. Select HR. 1 High and low alarm limits 2 Extreme Tachy and Extreme Brady limits ECG Alarms Off Disabled Be aware that your hospital department may have decided to disable the Alarms Off setting for ECG in the monitor's Configuration Mode. In this case, HR alarms cannot be switched off in Monitoring Mode. If you try to switch off the HR alarms, you will see the message To activate enter Config and enable Alarms Off. 126 6 ECG, Arrhythmia, ST and QT Monitoring HR Alarms When Arrhythmia Analysis is Switched Off When arrhythmia analysis is switched off, only these HR-related alarms will be detected:
the asystole alarm the ventricular fibrillation/tachycardia alarm the extreme tachycardia and extreme bradycardia alarms the high heart rate and low heart rate alarms. Enhanced Asystole Detection In order to improve alarming on asystole under certain conditions, you can set Asystole Detect. in Configuration Mode to Enhanced. In enhanced mode an asystole alarm will be suppressed for up to five seconds if a valid beat-to-beat Pulse is detected from an arterial Pressure. ECG Safety Information CAUTION Interference from instruments near the patient and ESU interference can cause problems with the ECG wave. See the monitor specifications for more information. WARNING Defibrillation and Electrosurgery:
Do not touch the patient, or table, or instruments, during defibrillation. After defibrillation, the screen display recovers within 10 seconds if the correct electrodes are used and applied in accordance with the manufacturers instructions. ECG cables can be damaged when connected to a patient during defibrillation. Check cables for functionality before using them again. According to AAMI specifications the peak of the synchronized defibrillator discharge should be delivered within 60 ms of the peak of the R wave. The signal at the ECG output on the IntelliVue patient monitors is delayed by a maximum of 30 ms. Your biomedical engineer should verify that your ECG/Defibrillator combination does not exceed the recommended maximum delay of 60 ms. When using electrosurgical (ES) equipment, never place ECG electrodes near to the grounding plate of the ES device, as this can cause a lot of interference on the ECG signal. General:
When you are connecting the electrodes or the patient cable, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth. During surgery:
Use the appropriate orange electrode ECG safety cable, or lead cable with an orange connector, for measuring ECG in the operating room. These cables have extra circuitry to protect the patient from burns during cautery, and they decrease electrical interference. This also reduces the hazard of burns in case of a defective neutral electrode at the HF device. These cables cannot be used for measuring respiration. 127 6 ECG, Arrhythmia, ST and QT Monitoring Pacemaker failure:
During complete heart block or pacemaker failure to pace/capture, tall P-waves (greater than 1/5 of the average R-wave height) may be erroneously counted by the monitor, resulting in missed detection of cardiac arrest. Patients exhibiting intrinsic rhythm:
When monitoring paced patients who exhibit only intrinsic rhythm, the monitor may erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest. The risk of missing cardiac arrest may be reduced by monitoring these patients with low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm alerts you when the patient's heart rate drops to a level where pacing is needed. Proper detection and classification of the paced rhythm can then be determined. Filtered ECG signal from external instruments:
Instruments such as defibrillators or telemetry units produce a filtered ECG signal. When this signal is used as an input to the bedside monitor, it is filtered again. If this twice-filtered signal is passed to the arrhythmia algorithm, it may cause the algorithm to fail to detect pace pulses, pacemaker non-capture, or asystole, thus compromising paced patient monitoring performance. External pacing electrodes:
When a pacemaker with external pacing electrodes is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This may result in the arrhythmia algorithm's failure to detect pacemaker noncapture or asystole. Fusion beat pacemakers:
Fusion beats, beats with pace pulse on top of the QRS complex, may not be detected by the monitor's QRS detector. Rate adaptive pacemakers:
Implanted pacemakers which can adapt to the Minute Ventilation rate may occasionally react on the Impedance measurement used by patient monitors for the determination of the Resp value and execute pacing with the maximum programmed rate. Switching off the Resp measurement can prevent this. Line isolation monitor transients:
When electrodes or lead wires are loose or detached, the monitor becomes susceptible to switching transients from some types of line isolation monitors. Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. To minimize the chance of this occurring, always adhere to the instructions for skin preparation and electrode placement given in this chapter. 128 About Arrhythmia Monitoring 6 ECG, Arrhythmia, ST and QT Monitoring Arrhythmia analysis provides information on your patient's condition, including heart rate, PVC rate, rhythm, and ectopics. The monitor uses the user-selected primary and secondary ECG leads for single-
lead or multi-lead arrhythmia analysis. During arrhythmia analysis, the monitor continuously:
optimizes ECG signal quality. This is important for arrhythmia analysis. The monitor continuously filters the ECG signal to remove baseline wander, muscle artifact, and signal irregularities. Also, if the Patient Paced status is set to Yes, pace pulses are filtered out to avoid processing them as QRS beats. detects beats, for example, QRS complexes, identifying them for further analysis. measures signal features such as R-wave height, width, and timing. creates beat templates, and classifies and labels beats to aid in rhythm analysis and alarm detection. examines the ECG signal for ventricular fibrillation, asystole, and noise. Arrhythmia Options Your monitor has either the basic or the enhanced arrhythmia option. Both options provide rhythm and ectopic status messages and beat labeling. The number of rhythms being classified, events being detected, and alarms generated differs according to the option. The alarms available with the different options are listed in the section ECG and Arrhythmia Alarm Overview on page 123, the rhythm and ectopic messages detected are listed in Arrhythmia Status Messages on page 132. Where Can I Find More Information?
See the Application Notes on ST and Arrhythmia supplied on your documentation DVD for detailed information on the arrhythmia algorithm and its clinical application. Switching Arrhythmia Analysis On and Off In the Setup Arrhy menu, select Arrhythmia to switch between On and Cardiotach. Select the Confirm pop-up key which appears at the bottom of the screen. 1 2 Be aware that when arrhythmia analysis is switched to Cardiotach mode, the message Cardiotach Mode appears beside the ECG wave, if configured to do so only the HR-related alarms are detected (the asystole alarm, the ventricular fibrillation/
tachycardia alarm, the extreme tachycardia and extreme bradycardia alarms, the high heart rate and low heart rate alarms) HR High and HR Low alarms behave like normal yellow alarms, no timeout periods are active. Choosing an ECG Lead for Arrhythmia Monitoring It is important to select a suitable lead for arrhythmia monitoring. Guidelines for non-paced patients are:
QRS complex should be tall and narrow (recommended amplitude > 0.5 mV) R-Wave should be above or below the baseline (but not bi-phasic) T-wave should be smaller than 1/3 R-wave height the P-wave should be smaller than 1/5 R-wave height. 129 6 ECG, Arrhythmia, ST and QT Monitoring For paced patients, in addition to the above, the pace pulse should be:
not wider than the normal QRS the QRS complexes should be at least twice the height of pace pulses large enough to be detected, with no repolarization. To prevent detection of P-waves or baseline noises as QRS complexes, the minimum detection level for QRS complexes is set at 0.15 mV, according to IEC 60601-2-27 and AAMI-EC 13 specifications. Adjusting the ECG wave size on the monitor display (gain adjustment) does not affect the ECG signal which is used for arrhythmia analysis. If the ECG signal is too small, you may get false alarms for pause or asystole. Aberrantly-Conducted Beats As P-waves are not analyzed, it is difficult and sometimes impossible for the monitor to distinguish between an aberrantly-conducted supraventricular beat and a ventricular beat. If the aberrant beat resembles a ventricular beat, it is classified as ventricular. You should always select a lead where the aberrantly-conducted beats have an R-wave that is as narrow as possible to minimize incorrect calls. Ventricular beats should look different from these 'normal beats'. Instead of trying to select two leads with a narrow R-wave, it may be easier to just select one lead and use single lead arrhythmia monitoring. Extra vigilance is required by the clinician for this type of patient. Atrial Fibrillation Alarm normal beat R-R intervals must be irregular P-R interval deviation must be large P-wave region must not match well The monitor performs atrial fibrillation analysis using information about the R-R irregularity, P-R interval variability and P wave variability. In order to generate an Afib alarm the following criteria must be detected for 1 minute:
Atrial fibrillation analysis is only available for adult patients and atrial fibrillation detection cannot be performed on PVCs or Paced beats. An * End AFIB alarm will occur when no atrial fibrillation waveform was detected for a configured delay time. Since most atrial flutters have regular R-R intervals, they cannot be detected by the atrial fibrillation algorithm. An * AFIB can be falsely detected in the presence of:
sinus arrhythmia, muscle noise, or If you also have monitors with earlier software revisions, the * AFIB and * End AFIB alarms will not be generated after a transfer to one of these monitors. Always leave the Irregular HR alarm switched on, so that this alarm can be generated in such situations. See the Application Note on Arrhythmia/ST supplied on your documentation DVD for detailed information on the arrhythmia algorithm and ECG analysis. electrode motion artifact. 130 6 ECG, Arrhythmia, ST and QT Monitoring Intermittent Bundle Branch Block Bundle branch and the other fascicular blocks create a challenge for the arrhythmia algorithm. If the QRS during the block changes considerably from the learned normal, the blocked beat may be incorrectly classified as ventricular, causing false PVC alarms. You should always select a lead where the bundle branch block beats have an R-wave that is as narrow as possible to minimize incorrect calls. Ventricular beats should look different from these 'normal beats'. Instead of trying to select two leads with a narrow R-wave, it may be easier to just select one lead and use single lead arrhythmia monitoring. Extra vigilance is required by the clinician for this type of patient. Understanding the Arrhythmia Display Your monitor screen may look slightly different from the illustration. Beat label Pace pulse marks 1 2 3 Rhythm status message 4 PVC Numeric 5 HR Numeric 6 Ectopic status message 7 Delayed arrhythmia wave Viewing Arrhythmia Waves To review arrhythmia beat labels, in the Setup Arrhy menu, select Annotate Arrhy. The wave showing the primary ECG lead will be delayed by six seconds and shown on a gray background. Beat labels will be annotated above the ECG wave and Delayed will be written beside it. To return to the normal ECG primary lead display, select Annotate Arrhy again. Arrhythmia Beat Labels Beat Classification Arrhythmia beat labels tell you how the monitor is classifying beats. Beat Label Arrhythmia On N V S P Normal Ventricular Ectopic Supra-ventricular Premature Paced Beat Label Cardiotach Mode B B B B 131 6 ECG, Arrhythmia, ST and QT Monitoring Beat Label Arrhythmia On
'
"
L A
?
I M Beat Classification Pacer Spike Biventricular Pacer Spike Learning patient's ECG Artifact (noisy episode) Insufficient information to classify beats Inoperative condition (e.g., Leads Off) Pause or missed beat Beat Label Cardiotach Mode
'
"
L A
?
I Not applicable Arrhythmia Status Messages Rhythm Status Messages -- to indicate the patient's rhythm. The monitor displays two types of status messages:
Ectopic Status Messages -- to indicate the presence of ectopic beats. These status messages are shown on the right hand side of the primary ECG wave. They are updated every second, with the exception of the Sinus and Supraventricular (SV) rhythm messages. The Sinus and SV rhythm messages are updated based on the current heart rate, taking into account the patient category (adult, pediatric, or neonatal). For the message to change from one rhythm status to another, the HR must be in the new range for five beats. If you have basic arrhythmia capability, you will get only messages for the alarms provided with this level. Rhythm Status Messages The label B or E indicates basic (B) or enhanced (E) arrhythmia capability. Rhythm Status Message Description Asystole No beat detected for a period > the asystole threshold
(2.5 - 4.0 seconds) Fibrillatory wave (sinusoidal wave between 2 - 10 Hz) for 4 consecutive seconds A run of consecutive beats labeled as V with run length the V-Tach Run limit and ventricular HR > V-Tach HR limit Ventricular tachycardia rhythm for more than 15 seconds A run of consecutive beats labeled as V with run length >
the Vent rhythm limit and ventricular HR the V-Tach HR limit A dominant rhythm of beats labeled as N, V, N, V, N A dominant rhythm of beats labeled as N, N, V, N, N, V, N, N A dominant rhythm of beats labeled as P Consistently irregular rhythm B or E B, E B, E B, E E E E E B, E E Vent Fib/Tach VTach Sustained VT Vent Rhythm Vent Bigeminy Vent Trigeminy Paced Rhythm Irregular HR 132 6 ECG, Arrhythmia, ST and QT Monitoring B or E B, E B, E B, E B, E B, E B, E B or E B, E B, E Rhythm Status Message Description Sinus Brady Sinus Rhythm Sinus Tach SV Brady SV Rhythm SV Tach Unknown ECG Rhythm Learning ECG Learning Rhythm Cannot Analyze ECG A dominant rhythm of beats labeled as N or S preceded by P-waves A dominant rhythm of beats labeled as N or S not preceded by P-waves Rhythm cannot be determined Algorithm is learning the ECG beat morphology Algorithm is learning the rhythm of the classified beats ECG signal is predominantly invalid or too noisy and therefore cannot be analyzed Ectopic Status Messages The label B or E indicates basic (B) or enhanced (E) arrhythmia capability. Ectopic Status Message Explanation
(No message displayed) Run PVCs Pair PVCs Pacer Not Capt PacerNotPacing Pause R-on-T PVCs Multiform PVCs Frequent SVPBs SVPBs SV Beats Paced Beats E E No ectopic activity within the last minute More than 2 consecutive beats labeled as V within the last minute Two beats labeled as V between two beats not labeled as V E No beat detected for a period > 1.75 times the average R-R interval and pace pulse(s) detected. (Paced mode on) No beat detected for a period > 1.75 times the average R-R interval and no pace pulse(s) detected (Paced mode on) No beat detected for a period > 1.75 times the average R-R interval for HR <120, or No beat for 1 second with HR >120 (non-paced patient only), or No beat detected for more than the set pause threshold. R-ON-T detected within the last minute Within the last minute, the occurrence of two differently shaped beats labeled as V within the last 60 beats and each occurring at least twice within the last 300 beats Count of beats labeled as S within last minute is greater than 5 1-5 beats labeled as S in the last minute Count of beats labeled as N or S within last minute and rhythm status is paced Count of beats labeled as P within last minute and rhythm status is not paced E E E E B, E B, E 133 6 ECG, Arrhythmia, ST and QT Monitoring Arrhythmia Relearning During a learning phase:
Alarm timeout periods are cleared Asystole, Vfib, and HR alarms (when there are enough beats to compute the HR) are active. No Stored arrhythmia templates are cleared other alarms are active. Initiating Arrhythmia Relearning Manually To initiate relearning manually, in the Setup Arrhy menu, select Relearn Arrhy. While the monitor is learning, the delayed arrhythmia wave displays the beat label L and the rhythm status message Learning ECG. Next, the monitor determines the dominant rhythm. The beats are labeled N, and the rhythm status message changes to Learning Rhythm. After relearning is complete, you should check the delayed arrhythmia wave to ensure that the algorithm is labeling the beats correctly. If beats are still not classified correctly, check that the ECG is optimized for arrhythmia monitoring. You may need to select a different lead or change the electrodes or electrode positions if there is excessive noise, unstable voltage, low amplitude, or large P- or T-waves. Automatic Arrhythmia Relearn Arrhythmia relearning is initiated automatically whenever:
ECG monitoring is switched on The ECG Lead or Lead Label of the primary/secondary lead is changed manually, or when fallback occurs A Leads Off INOP condition (that has been active for > 60 seconds) ends. If you are monitoring multi-lead arrhythmia and there is a change in one lead only, relearning happens only in the affected lead. During this learning phase, the system will continue monitoring using the other lead. Therefore, the delayed arrhythmia wave is not labeled L and there is no Learning ECG rhythm status message. In addition, alarm timeout periods are maintained, stored arrhythmia templates are maintained for the operative lead, and all alarms switched on are active. Arrhythmia Relearn and Lead Fallback Lead fallback triggers an automatic arrhythmia relearn. WARNING If arrhythmia learning takes place during ventricular rhythm, the ectopics may be incorrectly learned as the normal QRS complex. This may result in missed detection of subsequent events of V-Tach and V-
Fib. For this reason you should:
take care to initiate arrhythmia relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free be aware that arrhythmia relearning can happen automatically 134 6 ECG, Arrhythmia, ST and QT Monitoring respond to any INOP messages (for example, if you are prompted to reconnect electrodes) be aware that a disconnected EASI electrode triggers an arrhythmia relearn on all leads always ensure that the arrhythmia algorithm is labeling beats correctly. Arrhythmia Alarms Arrhythmia alarms can be switched on and off and the alarm settings changed just like other measurement alarms, as described in the Alarms section. Special alarm features which apply only to arrhythmia are described here. The different alarms detected and generated by the monitor depend on the level of arrhythmia analysis that is enabled. For a complete list of arrhythmia alarms and INOPs, see the Alarms chapter. The monitor detects arrhythmia alarm conditions by comparing ECG data to a set of pre-defined criteria. An alarm can be triggered by a rate exceeding a threshold (for example, HR >xx), an abnormal rhythm (for example, Ventricular Bigeminy), or an ectopic event (for example, Pair PVCs). Yellow Arrhythmia Alarms Yellow arrhythmia alarms are short yellow alarms specific to arrhythmia-related patient conditions. The heart rate alarms (High HR and Low HR) can be configured as short yellow or standard yellow alarms. When they are standard yellow alarms they exist independently of the other arrhythmia alarms and no timeout periods apply. WARNING When arrhythmia analysis is on, all yellow ECG and arrhythmia alarms are short yellow alarms (one-
star). This means that the yellow alarm lamp and the tones are active for six seconds only, after which the blinking numeric and the alarm message remain for up to three minutes. The only exception to this are the HR High and Low alarms which can be configured as standard yellow alarms. Red alarms behave as usual. Arrhythmia Alarms and Latching When using arrhythmia analysis, Visual Latching and Audible Latching should be on for red alarms, or at least Visual Latching should be on. Because of the transient nature of arrhythmia alarms, many arrhythmia conditions may go unnoticed if alarm latching is off. This setting can only be changed in Configuration Mode. Switching Individual Arrhythmia Alarms On and Off Some arrhythmia alarms can be individually switched on or off:
Non-Sustain, Vent Rhythm, Run PVCs, Pair PVCs, R-on-T PVCs, V.Bigeminy, V.Trigeminy, Multif.PVCs, Pacer n.Cap, Pacer n.Pac, Pause, SVT, IrregularHR, Missed Beat, PVCs/min and Afib. To switch individual alarms on or off, in the Setup Arrhy menu, select the alarm from the list to switch between On and Off. Depending on your configuration, some alarms may not be available in the list and cannot be switched on or off here. The monitor displays the INOP message Some ECG AlarmsOff, if configured, when more alarms are switched off than configured in your active profile. 135 6 ECG, Arrhythmia, ST and QT Monitoring Switching All Yellow Arrhythmia Alarms On or Off All yellow arrhythmia alarms can be switched on and off together. To do this, In the Setup Arrhy menu, select All Yellow Off or All Yellow On. Adjusting the Arrhythmia Alarm Limits Some arrhythmia alarms have limits which can be individually adjusted:
VTach HR, VTach Run, PVCs/min, Vent Rhythm, SVT HR, SVT Run, Asystole Thresh., Pause Threshold, Afib/
IHR End Dly. 1 2 To adjust alarm limits, in the Setup Arrhy menu, select the alarm to be adjusted. Select the appropriate setting from the pop-up list. Arrhythmia Alarm Timeout Periods Normally, an arrhythmia alarm is announced when an alarm condition is detected. However, there are certain situations that can inhibit the audible and visible indications of the alarm even though the alarm condition was detected. These include:
See Arrhythmia Alarm Chaining on page 137 for more details on alarm chains. if a more serious alarm condition is active in the same chain if a timeout period is in effect for a particular alarm if a timeout period is in effect for a higher alarm in that chain. What is a Timeout Period?
Timeout periods are automatically started when a yellow arrhythmia alarm is detected. During this period, the same alarm condition will not generate another alarm. Alarm conditions further down the same arrhythmia alarm chain will also not generate an alarm, but alarms further up the chain will: see Arrhythmia Alarm Chaining on page 137. To view the timeout period configured for your monitor, in the Setup Arrhy menu, see the menu items TimeOut 1st and TimeOut 2nd. This setting can only be changed in Configuration Mode.
** AFIB and ** Irregular HR alarms do not have a timeout period. These alarms can be generated immediately after the corresponding end alarm was generated. When ** HR High and ** HR Low alarms are configured as standard yellow alarms, they do not have a timeout period. Resetting the Timeout Period To reset the timeout period, press the Alarms key and then reselect it. 136 How are Yellow Arrhythmia Alarms Indicated?
6 ECG, Arrhythmia, ST and QT Monitoring When a yellow arrhythmia alarm is generated, it triggers visual and audible indicators. Yellow arrhythmia alarms are always set to latch visually for three minutes except HR High/Low alarms, if configured to standard yellow. Depending on the alarm condition, audible and visual alarm indicators will appear as follows:
Alarm Condition Example Single alarm instance Continuous alarm condition Non-Sustained V-tach PVCs/min HIGH Same intermittent alarm condition Pair of PVCs Short yellow alarm tone sounds when alarm condition is initially detected when alarm condition is initially detected and - as an alarm reminder - every time the configured timeout period has expired each time the alarm condition is detected, provided that the configured timeout period has expired Alarm message displayed for 3 minutes (latching time) until the alarm condition stops, plus a maximum of three minutes latching time If you silence a yellow arrhythmia alarm and the alarm condition still exists, the visual indicators continue until the condition stops. You will get an alarm reminder every time the configured timeout period has expired. If you silence a yellow arrhythmia alarm and the alarm condition has stopped, the visual indicators are immediately cleared. Silencing an alarm does not reset its timeout period, so you will not get a realarm for the same condition or lower on the chain until the timeout expires. Arrhythmia Alarm Chaining When arrhythmia analysis is switched on, multiple alarm conditions may be present. Announcing all of the detected alarm conditions would be confusing, and might hide a more serious condition. For this reason, arrhythmia alarms are prioritized in three alarm "chains": PVC Alarms; Beat Detection Alarms, and Rate Alarms. Only the highest priority alarm condition in each chain is announced. Lower priority alarms in the same chain will not be announced while an alarm is active or during the configured timeout period. If alarm conditions of equal severity from different chains are detected, the alarm condition that occurred most recently is announced. See ECG and Arrhythmia Alarm Overview on page 123 for information on which alarms are included in the different arrhythmia options. See Arrhythmia Alarm Timeout Periods on page 136 for an explanation of how alarm timeouts work. 137 6 ECG, Arrhythmia, ST and QT Monitoring Examples of Alarm Chaining Logic If there is an active Vent Bigeminy alarm, a PVCs > xx/min will not be triggered because it is lower on the same chain. However, a high HR alarm will become active because it is on a different chain. Higher priority alarms supersede previous alarms. For example, if a Vent Trigeminy alarm is active and a Pair PVCs occurs, the Pair alarm will be activated. 138 6 ECG, Arrhythmia, ST and QT Monitoring Understanding PVC-Related Alarms PVC-related alarms are detected on the basis of the current ventricular heart rate and the number of consecutive PVCs counted (referred to as PVC Runs). As an example, this diagram illustrates the conditions under which PVC alarms would be generated if the Vent Rhythm Run limit is set to 11, the V-Tach Run Limit is set to 8, and the V-Tach HR Limit is set to 100. You will see that if both the V-Tach Heart Rate Limit and the V-Tach Run Limit are exceeded, a red V-Tach alarm is generated if the ventricular heart rate exceeds the V-Tach Heart Rate Limit but not the V-Tach Run Limit, a yellow Non-Sustain VT alarm is generated. About ST Monitoring The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions. This information can be displayed in the form of ST numerics and snippets on the monitor. The monitor also performs ST Elevation (STE) analysis using automated ISO and J point determination and measuring the ST segment directly at the J point (J +0). This is based on the recommendations for measuring ST Elevation published by the American Heart Association, the American College of Cardiology and the European Society of Cardiology. All available leads can be monitored continuously. The ECG waveform does not need to be displayed on the monitor for ST Segment analysis. ST analysis is always performed using a dedicated filter which ensures diagnostic quality. If you are monitoring ECG using an ECG filter mode other than Diagnostic, the ST segment of the ECG wave may look different from the ST segment of the ST snippet for the same wave. For diagnostic evaluation of the ST segment, always switch to Diagnostic filter mode or use the ST snippet. 139 6 ECG, Arrhythmia, ST and QT Monitoring if you are unable to get a lead that is not noisy if arrhythmias such as atrial fib/flutter are present, which may cause an irregular baseline if the patient is continuously ventricularly paced if the patient has left bundle branch block. WARNING Some clinical conditions may make it difficult to achieve reliable ST monitoring, for example:
You should consider switching ST monitoring off if these conditions are present. This monitor provides ST level change information; the clinical significance of the ST level change information should be determined by a physician. ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. For this reason, the recommended - and default - setting for ST monitoring in neonatal and pediatric modes is ST Analysis: Off. Switching ST or STE On and Off ST and STE analysis can be switched on and off independently. To switch all ST monitoring on or off, in the Setup ST Analysis menu, select ST Analysis to switch between On and Off. To switch all STE monitoring on or off, in the Setup ST Elevation menu, select STE to switch between On and Off. Selecting Leads for ST Analysis You select which leads to use for ST analysis in the Setup ST Analysis menu. To see the current list of leads selected for ST analysis:
1 Enter the Setup ST Analysis menu. 2 Select Setup ST Leads. This opens the Setup ST Leads pop-up window. Leads chosen for ST monitoring are listed here. There are two pop-up keys at the bottom of the screen, Add and Delete. If all leads are already selected, the Add pop-up key is disabled. To choose a lead for ST monitoring:
1 Select the Add key at the bottom of the Setup ST Leads window. This opens the Choices pop-up window. 2 Choose a lead from the list for ST monitoring. This closes the Choices window and adds the selected lead to the list of chosen leads. To disable ST monitoring for a lead:
1 Choose a lead from the list in the Setup ST Leads window. 2 Select the Delete key. This removes this lead from the list. 140 6 ECG, Arrhythmia, ST and QT Monitoring NOTE The order in which ST leads are listed in the Setup ST Leads menu determines the order in which ST leads are displayed on the monitor screen. To change the order in which ST leads are displayed, 1 2 In the Setup ST Leads menu, choose a lead from the list. Select the Sort Up or Sort Down key to move the lead up or down in the list. Understanding the ST Display and Windows Your monitor screen may be configured to look slightly different from the illustrations. ST numerics 1 2 Current HR alarm limits 3 Current heart rate ST Numerics Up to 12 ST numerics plus the ST index can be displayed on the monitor screen. They can be configured to show beside the measurement numerics, beside the ECG wave, or beside the ST snippet. A positive ST value indicates ST segment elevation; a negative value indicates depression. ST numerics are displayed in the order in which you select ST leads for analysis. If there is additional space in the field assigned to ST numerics, the monitor will display extra numerics in the order in which they appear in the list in Setup ST Leads, in the Setup ST Analysis menu. Any ST leads switched on for analysis that do not fit in the assigned numerics field are shown in succession in place of the last ST numeric. ST Index The ST index numeric (STindx) is the sum of the absolute values for the ST leads V2, V5, aVF. Because it is based on absolute values, it is always a positive number. If you haven't selected one of the leads V2, V5, and aVF for ST analysis, the ST index numeric will display a question mark "?". To switch the ST index numeric on or off for display, in the Setup ST Analysis menu, select ST-Index to toggle between On and Off. ST Snippets ST snippets show a one second wave segment for each measured ST lead. The most recent snippet is drawn in the same color as the ECG wave, usually green, superimposed over the stored baseline snippet, drawn in a different color. The comparison shows any deviation in the measurement since the baseline snippet was stored, for example as a result of a procedure carried out on the patient. The information is updated once per minute. You can see ST snippets in the Adjust ST Points window or the ST View window. 141 6 ECG, Arrhythmia, ST and QT Monitoring ST View Window The ST View Window shows a current ST snippet and numeric with a baseline snippet and numeric. The two snippets are in different colors, so that you can differentiate between them easily and see at a glance which numerics belong to which snippet. In the upper left corner the current lead and the ISO/
J-Point mode for current and baseline snippets is shown. On the right side all available ST numerics are shown. The date and time of the baseline snippet is shown at the bottom of the window. The ST View Window opens with the ST pop-up keys Current / Baseline / Overlap (to select viewing mode), Show Points / Hide Points, Update Baseline, Record ST, STE View, Adjust ST Points, ST Map, Setup ST and arrow keys for scrolling through the available leads. To view the ST View window, select the ST numerics, then ST View. ISO/J-point mode for current snippet ISO/J-point mode for baseline snippet 1 mV calibration bar 1 Current Lead 2 3 4 5 Current ST snippet and ST baseline snippet overlapped 6 Timestamp of most recently stored baseline snippet 7 All available ST numerics for current snippet and baseline snippet The ST point, J-point and ISO point can be hidden using the Hide Points pop-up key. STE View Window The STE View window shows a current ST snippet and STE numeric with an ST baseline snippet. The two snippets are in different colors, so that you can differentiate between them easily. In the upper left corner the current lead is shown. On the right side all available STE numerics are shown. The date and time of the ST baseline snippet is shown at the bottom of the window. 142 6 ECG, Arrhythmia, ST and QT Monitoring The STE View window opens with the pop-up keys Current / Baseline / Overlap (to select viewing mode), Show Points/Hide Points, Record STE, ST View, ST Map, Setup ST and arrow keys for scrolling through the available leads. The ST point, J-point and ISO point can be hidden using the Hide Points pop-up key. Updating ST Baseline Snippets ST analysis requires valid samples to measure and store a snippet. ST Snippets and ST values are updated every minute. If there is artifact in the signal, it may take longer for an ST snippet and an ST value to appear. The first baseline is stored automatically after ST monitoring is started, or when a new patient is admitted. To update ST baselines, 1 2 Select the ST numerics then ST View to open the ST View window. In the ST View window, select Update Baseline to store all current snippets as baselines. This deletes all previously-stored baselines. About the ST Measurement Points The ST value for each beat complex is the vertical difference between the ISO point and the ST point, as shown in the diagram below. The isoelectric (ISO) point provides the baseline, the ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its slope; as it is a fixed distance away from the ST point, it can be useful to help you position the ST point correctly. 143 6 ECG, Arrhythmia, ST and QT Monitoring J point, for example, 48 msec 1 R-wave peak at 0 msec 2 3 Difference = ST value 4 ST measurement point, for example, J + 60 msec 5 Isoelectric point set to -80 msec 6 P 7 Q 8 S 9 T CAUTION If using ST analysis, the ST measurement points need to be adjusted when you start monitoring, and if the patient's heart rate or ECG morphology changes significantly, as this may affect the size of the QT interval and thus the placement of the ST point. Artifactual ST segment depression or elevation may occur if the isoelectric point or the ST point is incorrectly set. Always ensure that ST measurement points are appropriate for your patient. Setting ISO and J-Point Detection Mode There are two modes for ISO and J-point detection: Auto and Manual. In Manual mode you can set the measurement points yourself. In Auto mode the measurement points will be determined automatically. To set the detection mode, in the Setup ST Analysis window, 1 2 Select ISO/J Pt. Select Auto or Manual mode. Adjusting ST Measurement Points If the ISO and J-point detection mode is set to Manual, all three measurement points can be set. In Auto mode, only the ST point can be changed. 144 2 3 1 2 3 4 6 ECG, Arrhythmia, ST and QT Monitoring To adjust the ST measurement points, in the Setup ST Analysis menu, 1 Select Adjust ST Points to open the Adjust ST Points window. Alternatively, you can use the Adjust ST points pop-up key in the ST View window. Select a suitable ECG lead for ST measurement, with a visible J-point and a visible P wave. Use the up and down arrow keys to scroll through the ST snippets for the other ECG leads. Select the ST point you need to adjust by touching the appropriate point on the screen. The current choice is highlighted (ISO point -80 in the screen example). ST label and the ST numeric that would apply using the current points 1mV calibration bar Cursors for adjusting ST points Highlighted ST point The ISO-point cursor (1) positions the isoelectric point relative to the R-wave peak. The relation is shown beside the ISO-point in milliseconds. Position the ISO-point in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave). 145 6 ECG, Arrhythmia, ST and QT Monitoring The J-point cursor (2) positions the J-point relative to the R-wave peak. It helps you to correctly position the ST-point. Position the J-point at the end of the QRS complex and the beginning of the ST segment. The J-point cursor is not available if your monitor is configured to let you set the ST point directly. To position the ST-point (3) relative to the J-point:
select either J+60 or J+80. Select J Point and use the arrow keys to move the J-Point and position the ST-point at the midpoint of the ST segment. To position the ST-point directly:
select ST Point and use the left and right arrow keys to position the ST point at the midpoint of the ST segment. Select the Apply Changes pop-up key to activate the new ST measurement points and recalculate all ST values. The most recent ST Points adjustment time is displayed in the Adjust ST Points window. This information is cleared when a patient is discharged or when a new Profile is loaded into the monitor. 4 5 To update the ST snippet shown in the Adjust ST Points window, select the Update pop-up key. ST Alarms ST alarms are yellow alarms. Each ST lead has its own alarm limit. ST alarms are triggered when an ST value exceeds its alarm limit for more than one minute. Switching ST alarms off switches off alarms for all ST leads. If more than one ST measurement is in alarm, the monitor only displays the alarm message of the ST lead which is currently furthest from its set alarm limits. Changing ST Alarm Limits The monitor can detect alarms on each ST lead separately, so you can set high and low ST alarm limits individually for each ST lead. When two contiguous leads are available, ST alarms will be generated when ST values of the two contiguous leads are outside the limit. When no contiguous lead is available an ST alarm is generated when the ST value of the single lead is outside the limit. Set the high and low alarm limits based on your assessment of the patient's clinical condition, unit protocols, physician orders or medication-specified limits. A good guideline is + 1.0 mm or - 1.0 mm from the patients's ST, or follow your hospital protocol. 146 6 ECG, Arrhythmia, ST and QT Monitoring 1 2 In the Setup ST Analysis menu, select the alarm to be adjusted. Select the appropriate setting. STE Alarms The STE alarm is a yellow alarm. It can be switched on and off in the Setup ST Elevation menu but the limits can only be changed in Configuration mode. The STE alarm limits are gender specific and can be set individually for limb leads, V2/V3 leads, V1/V4/V5/V6 leads, V7/V8/V9 leads and V3R, V4R, V5R, V6R leads. The default values, for example on V2 and V3 1.5 mm for females and 2.0 mm for males, are based on the recommendations from the American Heart Association and American College of Cardiology. The ST Elevation measurements with automated J-point determination generate ST Elevation alarms, in addition to the ST measurements at the user-defined ST point (J+offset), which may be useful for ST depression alarms. When ST and STE analysis are both in use, this may result in redundant alarms for ST elevations. Because of the different measurement points, there may be different values obtained. Thus there could be an ST alarm and an STE alarm but the STE alarm may announce sooner based upon the values obtained. Viewing ST Maps The monitor can derive a multi-axis portrait (map) from the ST analysis to help you detect changes in ST values. Two planes obtained from a multi-lead ECG are displayed in a multi-axis diagram, where each axis represents a lead. The value at the ST point is given. The position of the axes within the diagram correspond to the placement of the ECG leads. Each ST value is assigned to either a limb lead, or to a chest lead. Every axis shows the polarity of the lead it represents. By joining adjacent ST values, the monitor obtains an ST map. The contour line and the map shading are shown in the same color as the ECG parameter. Viewing an ST Map To display an ST map, In the Main Setup menu, select ST Map. Current View In current view, the monitor displays an ST map that corresponds to the current ST values. The left of the following diagrams shows leads I, II, III, aVR, aVL, and aVF on the limb leads plane. On the right, the V-leads V1, V2, V3, V4, V5, V6 (and V7, V8, V9, V3R, V4R, V5R, V6R, if configured) are on the chest leads plane. 147 6 ECG, Arrhythmia, ST and QT Monitoring ST Alarm status indicator Limb Leads Chest Leads ST index Label, value and polarity of corresponding lead ST map 1 2 3 4 5 6 7 The position of the current ST measurement point If an ST lead is switched off, its axis is not shown in the map. If a lead is in INOP (the value is being measured but is invalid or unavailable because, for example, the corresponding ECG electrode is off), the area formed by the remaining ST leads is left open. If there is insufficient information (for example if no chest leads are measured) for a second ST map to be displayed, the currently available ST values are displayed in place of the second ST map. 148 6 ECG, Arrhythmia, ST and QT Monitoring Additionally, when both ST maps are displayed, you can view the currently available ST values in the ST Map (Current) or ST Map (Trend) window at any time. To do this, select the Show Values pop-up key. The ST values are shown in place of the second ST map, and the pop-up key text changes to Hide Values. Select the Hide Values Hide Values pop-up key and the display shows both ST maps again. Trend View In trend view, you can see up to four trended ST maps, and the current ST map, simultaneously. You can configure the time interval between trended samples. The most recent map is shown in the same color as the parameter itself. Past values change from white through dark gray. In the diagram below, the time interval between trends is one minute. The first trended sample is white and is one minute old. The second trended sample corresponds to the ST values two minutes ago and so forth. The ST values on the diagrams show the current ST values. If a lead is turned off, its axis is no longer shown. This has no impact on the presentation of trended values that were recorded while the lead was still on. 1 2 3 4 Limb Leads Chest Leads current ST values trending interval In this diagram, V4 was either temporarily switched off or in INOP for around 30 seconds. No data was recorded. Consequently, the affected maps are not closed. 149 6 ECG, Arrhythmia, ST and QT Monitoring Working in the ST Map Task Window You may need to activate the ST map task window to see all the data, and to access the pop-up keys. Select the map view on screen to activate its task window. Once you activate it, you can perform the tasks detailed here. Switching Between ST Map Views Select Current View or Trend View to toggle between views. To switch between views, If your trend view is empty, you need to adjust the priority of this measurement in the trending priority list. See Trend Priority on page 226. Displaying an ST Reference Baseline You can display an ST reference baseline for the current view, or for the trended view. The baseline is shown in yellow. However, if the ECG color is yellow, the baseline is shown in green. Use this baseline to detect ST changes. The baseline is derived automatically whenever the monitor relearns arrhythmia and also on user request. Select Show Baseline/Hide Baseline to toggle between baseline display on and off. Updating an ST Map Reference Baseline To update the baseline, In the Setup ST Analysis menu, select ST View then select Update Baseline. Changing the Scale of the ST Map To change scale, Select Size Up or Size Down to alter the size at which monitor displays the map. Changing the Trending Interval To determine how frequently the monitor displays a trended sample, 1 2 In Trend view, select Select Interval. Select the required interval from the menu. The interval ranges between 12 seconds to 30 minutes. Printing an ST Map Report To print the most recently viewed (current or trend) window, 1 2 3 Select Main Setup then select Reports. Select ST Map. Press Print. Viewing STE Maps The STE Map displays STE values, ST values measured at the J point, together with the STE Limits as configured in the Setup ST Elevation menu for the gender of the current patient. Just like ST Map, it displays two planes obtained from a multi-lead ECG in a multi-axis diagram, where each axis represents a lead. The position of the axes within the diagram correspond to the placement of the 150 6 ECG, Arrhythmia, ST and QT Monitoring ECG leads. Each STE value is assigned to either a limb lead, or to a chest lead. Every axis shows the polarity of the lead it represents. The STE limits are indicated by a gray colored area which contains all values that lie above those limits. If the ECG parameter color is white, shades of green are used instead. If two contiguous leads exceed the corresponding STE limits, the violation area between the two STE values and two corresponding limit values is colored in red. If the ECG parameter color is red, green is used instead. If the gender of the patient is not specified, the STE Map does not show any limits and does not indicate any limit violations. The STE Map does not provide Trend View or the ST baseline. STE Alarm status indicator Limb Leads Chest Leads Label, value and polarity of corresponding lead STE Limit Violations STE Limit Area 1 2 3 4 5 6 7 The position of the current ST measurement point (always J + 0) Viewing an STE Map To display an STE map, In the Main Setup menu, select STE Map. Working in the STE Map Task Window You may need to activate the STE map task window to see all the data, and to access the pop-up keys. Select the map view on screen to activate its task window. Once you activate it, you can perform the tasks detailed here. 151 6 ECG, Arrhythmia, ST and QT Monitoring Changing the Scale of the STE Map To change scale, Select Size Up or Size Down to alter the size at which monitor displays the map. Printing an STE Map Report To print the most recently viewed window, 1 2 3 Select Main Setup then select Reports. Select STE Map. Press Print. Switching between STE Map and ST Map If you are running ST Map or STE Map as an embedded screen application, you can switch back and forth between STE Map and ST Map by selecting the Change Map pop-up key. Note that changes made here will be saved in the current screen. About QT/QTc Interval Monitoring The QT interval is defined as the time between the beginning of the Q-wave and the end of the T-
wave. It measures the total duration of the depolarization (QRS duration) and repolarization (ST-T) phases of the ventricular action potential. QT interval monitoring can assist in the detection of prolonged QT interval syndrome. The QT interval (1) has an inverse relationship to heart rate. Faster heart rates shorten the QT interval and slower heart rates prolong the QT interval. Therefore there are several formulas used to correct the QT interval for heart rate. The heart rate corrected QT interval is abbreviated as QTc. The monitor uses as a default the Bazett correction formula and the alternative Fridericia formula can be selected in Configuration Mode. For QT interval monitoring to be effective, basic or enhanced arrhythmia monitoring should be turned on. QT Measurement Algorithm The QT values are updated every five minutes except in the initial phase (first five minutes) where they are updated once per minute. Normal or atrial paced beats and beats with a similar morphology are averaged to form a representative waveform for further processing. Normal beats followed by a premature QRS will be excluded from the measurements to prevent the premature beat from 152 6 ECG, Arrhythmia, ST and QT Monitoring obscuring the end of the T-wave. If the algorithm cannot form a representative waveform, for example because the morphology of the beats is too varied, a Cannot Analyze QT INOP will be generated after 10 minutes. This is also the case if normal beats have been falsely labeled so that the algorithm does not have enough valid beats to make QT measurements. No QT value is calculated if the QT-HR is
>150 bpm (Adult) or >180 bpm (Pedi/Neo). Because of the different algorithm approaches, a QT/QTc measurement from a diagnostic 12-lead program may differ from the realtime measurement on the monitor. Where Can I Find More Information?
See the Application Note on QT/QTc Interval Monitoring and the QT Interval Monitoring Quick Guide supplied on your documentation DVD for detailed information on the QT algorithm and performance. Indications For Use Of QT Interval Monitoring Of special concern for QT monitoring is the administration of QT prolonging drugs to patients identified with risk factors for Torsade de Pointe. Females, older patients and patients with bradycardia, impaired left ventricular function (ischemia, left ventricular hypertrophy), hypokalemia and hypomagnesemia are in this increased risk category. Limitations For Use Of QT Interval Monitoring the T-wave is very flat T-waves are not well defined due to atrial flutter or atrial fibrillation the end of the T-wave is difficult to define because of the presence of U-waves a high heart rate causes the P-wave to encroach on the end of the previous T-wave noise or high QRS morphology variation Some conditions may make it difficult to achieve reliable QT monitoring, for example:
For these cases you should select a lead with a good T-wave amplitude and no visible flutter activity, and without a predominant U-wave or P-wave. Some conditions such as left or right bundle branch block or hypertrophy can lead to a widened QRS complex. If a long QTc is observed you should verify it to ensure that it is not caused by QRS widening. Because normal beats followed by ventricular beats are not included in the analysis, no QT measurement will be generated in the presence of a bigeminy rhythm. If the heart rate is extremely high (over 150 bpm for adults and over 180 bpm for pediatrics and neonates) QT will not be measured. When the heart rate changes, it can take several minutes for the QT interval to stabilize. For reliable QTc calculation it is important to avoid a region where the heart rate is changing. WARNING QT/QTc measurements should always be verified by a qualified clinician. 153 6 ECG, Arrhythmia, ST and QT Monitoring Selecting the QT Leads For QT Monitoring you can select one of the following three modes:
All Leads mode - all available leads (I, II, III, V, MCL, V1 - V9, V3R to V6R) are used to produce a global QT measurement. For EASI lead placement, directly acquired AI, AS and ES leads are used. Primary-Lead mode - the primary lead will be used for QT measurement. If the original primary lead becomes unavailable or is changed, QT measurement will continue with the new primary lead. Single-Lead mode - a single lead selected from all available leads (except the augmented leads) will be used for QT measurement. QT measurement will stop if the selected lead becomes unavailable. Select the QT numeric to enter the Setup QT Analysis window. Select QT Lead and select All, Primary Lead or one of the available single leads. To select the mode, 1 2 When using the All Leads mode, make sure when you compare QT values that they are based on the same set of leads. Changing the lead(s) used for QT measurements will not cause the baseline to be reset. QT View In the QT View window you can verify that the QT algorithm detects correct Q and T points. The current waves are shown in the upper half of the window and the baseline waves in a different color below. The Q and T points are marked with a vertical line. By selecting one of the lead labels at the top of the window you can highlight the corresponding wave; the other waves are shown in gray. The underlined lead labels are the leads used for the QT calculation. By selecting the numeric area you can highlight all underlined leads. If EASI or Hexad lead placement is in use, the corresponding lead placement label will be shown. 154 6 ECG, Arrhythmia, ST and QT Monitoring Changing The View To A Single Wave Set To view one set of waves in a larger scale, you can cycle through the different views, 1 2 3 Select Current view to see the set of current waves. Select Baseline view to see the set of baseline waves. Select Split view to return to the combined view with current and baseline waves. Setting The QT Baseline Select Set Baseline and set the value. In order to quantify changes in the QTc value, you can set a QTc baseline. For example to assess the effect of medication on the QT interval you can set the current value as the baseline before you begin medication. This baseline will then be used to calculate the QTc value. To set the baseline, If no baseline has been set for this patient, the first five minute value after the start of monitoring is automatically set as baseline. If you set a new baseline the previous baseline is discarded. As the QTc alarm is based on the difference between the baseline and the current value, setting an inappropriate new baseline may prevent a QTc alarm from being generated. Discharging a patient clears the baseline. Printing The QT Waves To start a printout, Select Print QT. Recording The QT Waves To start a recording, Select Record QT. QT Alarms There are two QT alarms, QTc high limit alarm and QTc high alarm. The QTc high limit alarm is generated when the QTc value exceeds the set limit for more than 5 minutes. The QTc alarm is generated when the difference between the current value and the baseline value exceeds the set limit for more than 5 minutes. The Cannot Analyze QT INOP and the -?- will be displayed when no QT measurement could be calculated for 10 minutes. Up to this time the previous valid value will be displayed. The following additional messages on the cause of the invalid measurements may also be displayed. Additional Message QT Startup Asystole or Leads Off Too few N labeled beats Cause of Invalid QT Measurement QT monitoring was just turned on or has been reset 1 Not all specified leads needed to perform QT analysis are available, or 2 Asystole condition is detected Not enough valid QRS complexes to generate a QT measurement 155 6 ECG, Arrhythmia, ST and QT Monitoring Additional Message Invalid Rhythm for QTc High QT-HR Small R Wave Small T Wave End of T not Detected QT out of Range QTc out of Range QTc Erratic Cause of Invalid QT Measurement Not enough valid R-R intervals to generate QT-HR, the averaged HR used for QTc calculation QT-HR exceeds the specified upper limit of 150 bpm (for adults) or 180 bpm (for neonates and pediatrics) R-wave of the signal is too small T-wave of the signal is too small End of the T-Wave cannot be accurately detected QT measurement is outside the specified range of valid QT values
(200-800 msec) QTc measurement is outside the specified range of valid QTc values
(200-800 msec) QTc measurements are not stable Switching Individual QTc Alarms On and Off Each QTc alarm can be switched off individually. To switch an alarm on or off, in the Setup QT Analysis menu, select QTc Alarm or QTc Alarm to toggle between On and Off. Changing QTc Alarm Limits Set the high alarm limits based on your assessment of the patient's clinical condition, unit protocols, physician orders or medication specified limits. 1 2 3 4 In the Setup QT Analysis menu, select High Limit. Select the appropriate setting. Select HighLimit. Select the appropriate setting. Switching QT Monitoring On and Off To switch all QT monitoring on or off, in the Setup QT Analysis menu, select QT Analys. to switch between On and Off. 156 7 7Monitoring Pulse Rate The pulse numeric counts the arterial pulsations that result from the mechanical activity of the heart in beats per minute (bpm). You can display a pulse from any measured SpO2 signal (pleth wave), from the CL Respiration Pod, or any arterial pressure (P, ABP, ART, Ao, PAP, UAP, FAP, BAP: see the Monitoring Invasive Pressure chapter for an explanation of the pressure labels). The displayed pulse numeric is labeled and color-coded to match its source wave. If the pulse numeric is not displayed, see the Setup Pulse menu to check whether it is switched on. Entering the Setup Pulse Menu If a pulse numeric is displayed on the screen, select it to enter the setup menu for that pulse source. If no pulse numeric is visible, in the setup menu from the measurement, select pulse with the correct source, e.g. Pulse (HR). System Pulse Source is monitored as system pulse and generates alarms when you select pulse as the active alarm source is sent via the network to the Information Center, if available is trended in the HighRes Trends and stored in the monitor's databases. The currently selected system pulse source is shown in the setup menus of the pulse source measurements. The pulse rate chosen as system pulse:
To define which pulse rate is used as system pulse, 1 2 In the Setup Pulse menu, select System Pulse. Select one of the SpO2, cmResp or arterial pressure labels from the pop-up list, or select Auto. If you select Auto, the monitor automatically chooses a pulse rate to be used as system pulse. It looks through the list from top to bottom and activates the first pulse rate that is switched on and available. If your selected pulse source measurement becomes unavailable or is switched off, the monitor will use the next measurement from the list as system pulse until the selected pulse source measurement becomes available again. 157 7 Monitoring Pulse Rate Switching Pulse On and Off To switch a particular pulse numeric on or off, enter the Setup Pulse menu via the measurement setup menu or wave menu of the pulse source. For example, to switch an SpO2 pulse numeric on or off, 1 Enter the Setup Pulse menu by selecting the Pulse numeric or by selecting Pulse in the Setup SpO menu. In the Setup Pulse menu, select the correct pulse label, e.g. Pulse (SpO), to toggle between On and Off. 2 Using Pulse Alarms You can change pulse rate alarm limits in the ECG/Pulse Alarms menu which can be accessed from the Setup Pulse menu or the Setup ECG menu by selecting AlarmSrc(xxx) where xxx is the current alarm source. Changing the alarm limits for a specific Pulse numeric changes the alarm limits for all pulse rate alarms and heart rate alarms. Pulse alarms are only generated when the active alarm source is set to Pulse, a pulse source is set as system pulse and pulse alarms are switched on. Selecting the Active Alarm Source: ECG or Pulse?
In most cases the HR and Pulse numerics are identical. In order to avoid simultaneous alarms on HR and Pulse, the monitor uses either ECG or Pulse as its active alarm source. To change the alarm source, select Al. Source in the ECG/Pulse Alarms menu, then select ECG/Arrhythm: if you want the HR to be the alarm source for HR/Pulse. Pulse: If you select Pulse as the active alarm source, the monitor will prompt you to confirm your choice. Be aware that if you select Pulse as the alarm source, all arrhythmia and ECG HR alarms are switched off. Auto: If the alarm source is set to Auto, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without an INOP condition. The monitor will automatically switch to Pulse as the alarm source if:
a valid ECG lead can no longer be measured and a Pulse source is switched on and available, The monitor then uses the pulse rate from the measurement currently active as system pulse. While Pulse is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the monitor automatically uses HR as alarm source. NOTE If ECG is switched off, the monitor will always change to Pulse as alarm source, if a Pulse is available. One exception to this rule can arise when you have a telemetry device paired with your monitor. The monitor ECG is then deactivated but the monitor may be configured to allow only ECG as the active alarm source. In this case the monitor will not switch to Pulse as alarm source and Pulse will not be available as a selection in the ECG/Pulse Alarms menu. 158 7 Monitoring Pulse Rate WARNING Selecting Pulse as the active alarm source for HR/Pulse switches off the arrhythmia alarms listed in the section ECG and Arrhythmia Alarm Overview on page 123, including Asystole, Vfib and Vtach alarms, and the heart rate alarms. This is indicated by the message ECG/Arrh AlarmsOff (unless this has been configured off for your monitor), and the crossed-out alarm symbol beside the ECG heart rate numeric. The message ECG/Arrh AlarmsOff can be configured off, or to switch to a yellow (medium severity) INOP after a fixed number of hours. High and low pulse rate and extreme bradycardia and extreme tachycardia alarms from pulse are active. Alarm Source Selection Disabled If you cannot change the alarm source, selection of the alarm source may be disabled. If you try to change the source, the monitor displays the message To activate enter Config and enable Alarm Source Selection. This setting can only be changed in Configuration Mode. Changing HR/Pulse Alarm Limits As Pulse and HR share the same high and low alarm limits, if you change the alarm limit in the Setup Pulse menu, the high or low alarm limits for HR in the Setup ECG menu change automatically, and vice versa. The only exceptions are caused by a low limit clamp for each measurement: the lowest value for Pulse when derived from SpO2 is 30 bpm; from HR 15 bpm, and from Pressure 25 bpm. Extreme Alarm Limits for Heart Rate The extreme rate alarms, *** Extreme Tachy and *** Extreme Brady, are generated by the active alarm source, either HR or Pulse. The limits are set automatically by adding a set value (the value) to the high and low alarm limits. So, changing the high and low alarm limits automatically changes the extreme alarm limits (within an allowed range, see Extreme Alarm Limits for Heart Rate on page 125 for details). You need to know which value has been configured for your monitor. To see the values added to the high and low limit alarms to create the extreme rate alarms for your monitor, in the Setup ECG menu, see the menu items ExtrTachy and ExtrBrady. QRS Tone The active alarm source is also used as a source for the QRS tone. You can change the tone volume in the Setup SpO and Setup ECG menus and the QRS tone modulation in the Setup SpO menu. WARNING The audible QRS tone might be influenced by external interference and is not intended to be used as a substitute for ECG based arrhythmia analysis. If arrhythmia detection is needed, do not rely on the audible QRS tone. 159 7 Monitoring Pulse Rate 160 8 8Monitoring Respiration Rate
(Resp) For the respiratory measurement (Resp), the monitor measures the thoracic impedance between two ECG electrodes on the patient's chest. Changes in the impedance due to thoracic movement produce the Resp waveform on the monitor screen. The monitor counts the waveform cycles to calculate the respiration rate (RR). Lead Placement for Monitoring Resp Correct patient skin preparation techniques for electrode placement are important for Resp measurement: you will find this information in the chapter on ECG. The Resp measurement uses the standard ECG cable sets and lead placements. You can use any of the different types of ECG cable sets - 3-lead, 5-lead, 6-lead or 10-lead, using either standard or EASI placement - to measure Resp, as long as you use ICU ECG cables. The Resp signal is always measured between two of the ECG electrodes. Note that at least a standard 3-lead placement is required to measure Resp. The Resp measurement cannot be performed with only two electrodes. Selecting the Resp Lead for Measurement To choose the leads for the Resp measurement:
In the Setup Resp menu, select Resp Lead and choose one of the following vectors:
Note that if EASI is configured, Respiration will be measured between the I and A electrodes. I (RA-LA) or II (RA-LL). Optimizing Lead Placement for Resp If you want to measure Resp and you are already measuring ECG, you may need to optimize placement of the two electrodes between which Resp will be measured for some patients. Repositioning ECG electrodes from standard positions, especially when you are using EASI ECG electrode placement, results in changes in the ECG waveform and may influence ST and arrhythmia interpretation. 161 8 Monitoring Respiration Rate (Resp) Cardiac Overlay Cardiac activity that affects the Resp waveform is called cardiac overlay. It happens when the Resp electrodes pick up impedance changes caused by the rhythmic blood flow. Correct electrode placement can help to reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. This is particularly important for neonates. Lateral Chest Expansion Some patients, especially neonates, expand their chests laterally. In these cases it is best to place the two respiratory electrodes in the right midaxillary and left lateral chest areas at the patient's maximum point of breathing movement to optimize the respiratory wave. Abdominal Breathing Some patients with restricted chest movement breathe mainly abdominally. In these cases, you may need to place the left leg electrode on the left abdomen at the point of maximum abdominal expansion to optimize the respiratory wave. Understanding the Resp Display The Resp measurement is displayed on the monitor as a continuous wave and a numeric respiration rate. If the detected respiration rate is close to the heart rate, this is indicated by the text HR = RR next to the respiration wave if you are in manual monitoring mode. Your monitor screen may look slightly different from the illustration. 1 Resp wave label 2 One Ohm calibration bar 3 Manually-set Resp detection level 4 Resp numeric and label 162 8 Monitoring Respiration Rate (Resp) Changing Resp Detection Modes The Resp detection level can be set either automatically or manually. To change the resp detection mode, in the Setup Resp menu, select Detection to toggle between the settings. Auto Detection Mode the detection level (a dotted line) is not displayed on the waveform, the algorithm expects a heart rate and therefore needs at least 3 electrodes attached to the patient. In Auto Detection Mode, the monitor adjusts the detection level automatically, depending on the wave height and the presence of cardiac artifact. Note that in Auto Detection Mode, Use Auto Detection Mode for situations where:
the respiration rate is not close to the heart rate breathing is spontaneous, with or without continuous positive airway pressure (CPAP) patients are ventilated, except patients with Intermittent Mandatory Ventilation (IMV). Manual Detection Mode In Manual Detection Mode you must set the Resp detection level. In the Setup Resp menu, select Manual Up or Manual Down. Use the dotted detection level line in the Resp waveform to determine when the desired level is reached. Once set, the detection level will not adapt automatically to different respiration depths. It is important to remember that if the depth of breathing changes, you may need to change the detection level. Use Manual Detection Mode for situations where:
the respiration rate and the heart rate are close. patients have Intermittent Mandatory Ventilation. respiration is weak. Try repositioning the electrodes to improve the signal. Resp Detection Modes and Cardiac Overlay In Auto Detection Mode:
If you are monitoring Resp and the ECG is switched off, the monitor cannot compare the ECG and Resp rates to detect cardiac overlay. The respiration detection level is automatically set higher to prevent the detection of cardiac overlay as respiration. In Manual Detection Mode:
Cardiac overlay can in certain situations trigger the respiration counter. This may lead to a false indication of a high respiration rate or an undetected apnea condition. If you suspect that cardiac overlay is being registered as breathing activity, raise the detection level above the zone of cardiac overlay. If the Resp wave is so small that raising the detection level is not possible, you may need to optimize the electrode placement as described in the section Lateral Chest Expansion on page 162. 163 8 Monitoring Respiration Rate (Resp) Changing the Size of the Respiration Wave WARNING When monitoring in Manual Detection Mode, make sure to check the respiration detection level after you have increased or decreased the size of the respiration wave. In the Setup Resp menu, select Size Up to increase the size of the wave or Size Down to decrease it. Changing the Speed of the Respiration Wave Resp waveforms are usually viewed at a slower speed than other waveforms. For this reason, the Resp measurement has its own speed control and is not affected by the wave speed settings of the other measurements. Select the Resp wave to enter the Resp Wave menu, then select Change Speed. Choose the required speed from the pop-up list. This defines the speed at which the wave is drawn across the screen in millimeters per second (mm/s). Using Resp Alarms Resp alarms can be switched on and off and the high and low alarm limits can be changed just like other measurement alarms, as described in the Alarms chapter. Changing the Apnea Alarm Delay The apnea alarm is a high priority red alarm used to detect apneas. The apnea alarm delay time defines the time period between the point where the monitor cannot detect any respiration activity and the indication of the apnea alarm. 1 2 In the Setup Resp menu, select Apnea Time. Select the appropriate setting. Resp Safety Information WARNING Respiration detection level If you do not set the detection level for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect apnea. If you set the detection level too low, the monitor is more likely to detect cardiac activity, and to falsely interpret cardiac activity as respiratory activity in the case of apnea. Apnea The respiration measurement does not recognize obstructive and mixed apneas - it only indicates an alarm when a pre-adjusted time has elapsed since the last detected breath. The safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. 164 8 Monitoring Respiration Rate (Resp) Interference If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3V/
m), field strengths above 1V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit. Resp Accessories To monitor respiration, use only the non-OR ECG accessories listed in the Resp section of the accessories chapter. You cannot measure respiration if you are using an orange OR ECG cable set. This is because of the higher internal impedance of the OR cable set, required for use if electrosurgery is being performed. Rate adaptive pacemakers Implanted pacemakers which can adapt to the Minute Ventilation rate may occasionally react on the Impedance measurement used by patient monitors for the determination of the Resp value and execute pacing with the maximum programmed rate. Switching off the Resp measurement can prevent this. 165 8 Monitoring Respiration Rate (Resp) 166 9 9Monitoring with the CL Respiration Pod (cmResp) The CL Respiration Pod is one of the IntelliVue Cableless measurements and can be used together with the monitor. For information on the general use and application of the pod, refer to Using IntelliVue Cableless Measurements on page 35 and the IntelliVue Cableless Measurements Instructions for Use. As the Respiration Pod does not have a display, the measurement results are only presented on the monitor display, and the settings for the measurement can also only be made at the monitor. Information relating to these aspects is contained in this chapter. Measurement Principles The CL Respiration Pod derives a respiration and pulse signal from the chest and abdomen movements measured with a built-in acceleration sensor. The CL Respiration Pod is attached to the left costal arch on the patient's chest with an adhesive attachment. With the appropriate configuration, the measurement provides:
a respiration waveform (cmResp) a respiration rate (cmRR) a pulse numeric (optional) a posture status - various different postures such as supine, upright and lying on left/right side are detected and updated after a posture change has occurred and posture is stable again. an activity level numeric - patient activity is determined once per second, and an activity level between 0 and 10 is reported to the monitor and updated once per minute. The activity status information provides only an approximate indication of the actual patient activity. WARNING The CL Respiration Pod does not provide apnea alarming. Excessive patient movement and vibration can cause interference with the measured signals. When the patient is mobile, motion artifacts could be interpreted as breathing movements. 167 9 Monitoring with the CL Respiration Pod (cmResp) Measurement Modes There are three different modes available for making respiration/pulse measurements:
Manual Mode - a single respiration measurement is made when Start cmResp is selected at the monitor or when the key on the Respiration Pod is pressed. Automatic Mode - continually repeated respiration measurements with an adjustable interval between them. The first measurement starts immediately after entering the automatic measurement mode. If configured, when the respiration rate moves outside the defined alarm limits, the measurement mode changes automatically to frequent mode until the respiration rate moves back inside the limits. Frequent Mode - respiration and pulse are measured continuously. The respiration rate is updated with every new detected breath. The shortest update interval for the pulse rate is 8 seconds. Making Measurements For the procedures for preparing the pod and making measurements, refer to the IntelliVue Cableless Measurements Instructions for Use. To start a measurement from the monitor, select Start cmResp in the Setup cmResp menu. A single measurement can be started at any time, independent of the current measurement mode. Understanding the Numerics 1 Measurement Mode 2 Repeat time (only in automatic mode) 3 Timestamp for numerics 4 5 6 7 Pulse numeric cmRR numeric cmRR alarm limits Signal Quality indicator In automatic mode, you may see the time until the next measurement instead of the timestamp, depending on your configuration. The time is shown like this:
The cmRR and pulse numerics can be configured to be grayed out or to disappear from the screen after a set time. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration mode. When an automatic measurement is ongoing, the numerics are replaced by horizontal bars, constantly changing from one bar, to two, then to three. 168 9 Monitoring with the CL Respiration Pod (cmResp) Signal Quality Indicator The cmRR and pulse numerics are displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. The level to which the triangle is filled shows the quality of the signal; the indicator below shows maximum signal quality with the triangle completely filled. Activity Numeric The activity level of the patient is indicated by a numeric value between 1 (very low activity) and 10
(very high activity). When a value of 0 is displayed, no signal is available. The numeric is updated once per minute. An activity level value is also displayed at the top of the Setup cmResp menu. Here the "realtime" value is shown, allowing you check that activity is being successfully detected. Posture Indication The posture is displayed in text form, with the name of the detected posture and the time since the last posture change was detected. The indication is updated when a posture change is detected and the new posture has been stable for 1 minute. A posture indication is also displayed at the top of the Setup cmResp menu. Here the "realtime"
indication is shown, allowing you check that posture changes are being successfully detected. Setting the Measurement Mode To set the measurement mode:
1 2 In Auto or Frequent mode, measurements will start immediately after the mode is selected. In the Setup cmResp menu, select Mode. Select Manual, Auto or Frequent mode. Setting the Repeat Time For Auto mode measurements you can set the interval between measurements:
1 2 In the Setup cmResp menu, select Repeat Time. Select the interval from the list. 169 9 Monitoring with the CL Respiration Pod (cmResp) Switching Posture and Activity Level On and Off In the Setup cmResp menu, select Posture or Activity to switch between On and Off. 170 10 10Monitoring SpO2 Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact suppression technology (FAST). It provides four measurements:
Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). Pleth waveform - visual indication of patient's pulse. Pulse rate (derived from pleth wave) - detected pulsations per minute. Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. The monitor is also compatible with an SpO2 technology from another manufacturer: Nellcor OxiMax. Where use of this technology results in different behavior or has different requirements, the differences are described in these Instructions for Use. WARNING A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory CO-oximeter to completely understand the patient's condition. SpO2 Sensors Familiarize yourself with the instructions for use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. CAUTION Do not use OxiCliq disposable sensors in a high humidity environment, such as in neonatal incubators or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive. 171 10 Monitoring SpO2 Applying the Sensor Follow the SpO2 sensor's instructions for use, adhering to all warnings and cautions. 1 2 Remove colored nail polish from the application site. 3 Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. 4 When using the M1195A Infant Finger Sensor, select a finger or toe with a diameter of between 7 and 8 mm (0.27" and 0.31"). When applying a M1193A neonatal sensor do not overtighten the strap. 5 Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue. WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. MRI Scanning: Do not use the pulse oximeter or oximetry sensors during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The device may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. Damaged Sensors: Do not use damaged sensors / cables or sensors with exposed optical components. Low Perfusion: With very low perfusion at the monitored site, the performance might be impaired and the SpO2 readings may read lower than arterial oxygen saturation. Conditions Affecting Performance: During hypotension, severe vasoconstriction, severe anemia, or hypothermia of the patient the performance may be impaired. Also in these conditions or when the patient is in cardiac arrest or in shock, it may not be possible to make measurements at all. Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41C on the skin if the initial skin temperature does not exceed 35C. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line. Do not immerse the sensors. Nellcor OxiMax technology: This product contains chemicals known to the state of California to cause cancer and birth defects or other reproductive harm. 172 Connecting SpO2 Cables 10 Monitoring SpO2 Connect the sensor cable to the color-coded socket on the monitor. You can connect some Philips sensors directly to the monitor. For other sensors, use the corresponding adapter cable. CAUTION Extension cables: Do not use more than one extension cable (M1941A). Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "long"
cable version). Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference. Humidity: For neonatal patients, make sure that all sensor connectors and adapter cable connectors are outside the incubator. The humid atmosphere inside can cause inaccurate measurements. Measuring SpO2 1 Select the correct patient category setting (adult/pediatric and neonatal), as this is used to optimize the calculation of the SpO2 and pulse numerics. 2 During measurement, ensure that the application site:
has a pulsatile flow, ideally with a perfusion indicator value above 1.0. has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor. WARNING If not specified otherwise in the SpO2 sensor's instructions for use, the following applies:
For fully conscious pediatric or adult patients, who have a normal function of perfusion and sensory perception at the measurement site:
To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients:
Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream. Interference can be caused by:
High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) 173 10 Monitoring SpO2 Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference. Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium. Excessive patient movement and vibration. Understanding the SpO2 Numerics 1 Measurement Mode (only with the IntelliVue CL SpO2 Pod, in Auto or Manual mode) 2 Repeat time (only with the IntelliVue CL SpO2 Pod, in Auto mode) 3 Timestamp for numerics (only with the IntelliVue CL SpO2 Pod or a telemetry device) Pulse numeric Perfusion Numeric 4 5 6 Alarms off indicator (here for Pulse alarms) 7 8 9 SpO2 numeric SpO2 alarm limits Signal Quality indicator In automatic mode, you may see the time until the next measurement instead of the timestamp, depending on your configuration. The time is shown like this:
When an automatic measurement is ongoing, the numerics are replaced by horizontal bars (1, 2 or 3 bars, in turn). SpO2 numerics from intermittent measurements (from the IntelliVue CL SpO2 Pod or a telemetry device) can be configured to be grayed out or to disappear from the screen after a set time. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration mode. SpO2 Signal Quality Indicator (FAST SpO2 only) The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. 174 The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality, the signal quality is at a maximum when the triangle is completely filled. 10 Monitoring SpO2 Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse. When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value. If you doubt the measured SpO2, use the signal quality indicator (if available) or the pleth wave and perfusion indicator instead to assess the signal quality. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. Comparing Values and Waves Be aware when using two different SpO2 technologies that under certain conditions the displayed values and especially the perfusion values may differ due to the different algorithms used. Changing the Averaging Time Depending on the monitor configuration, you may be able to change the averaging time for the SpO2 values. The averaging time represents the approximate time period used for the calculation. The exact averaging algorithm depends on the SpO2 technology (option) used and on the signal conditions. The longer the averaging time, the longer the time needed until the SpO2 value reflects the physiological event. Fast averaging is useful for situations where an extremely fast measurement is required or few artifacts are expected. Use slow averaging where you expect the number of artifacts to be relatively high. 1 2 In the Setup SpO menu, select Average. Select the required averaging time from the list. 175 10 Monitoring SpO2 Setting the Measurement Mode When a telemetry device supplies SpO2T to the monitor via short range radio transmission, the monitor will have a manual measurement mode available. This allows SpO2 measurements to be made on request and not continuously, helping to save the telemetry devices battery power. When an IntelliVue CL SpO2 Pod is providing SpO2 measurement data to the monitor via short range radio, the monitor will have manual and automatic measurement modes available. To set the measurement mode, 1 2 In the Setup SpO menu, select Mode. Select Continuous, Manual or Auto mode (if available). NOTE To ensure there is no gap in SpO2 measurements when moving from standard telemetry transmission to short range radio transmission, the measurement mode will always be set to continuous in this situation unless manual mode is set in both the telemetry device and the monitor. Making a Manual Measurement In the Setup SpO menu, select Start SpO, or use the Start SpO SmartKey. When the measurement mode is set to manual, When manual measurements are made, there will be no continuous SpO2 monitoring or alarming. The manual measurement value reflects a momentary status. The numerics from SpO2T measurements made in manual mode, for example SpO2T, PerfT, PulseT, will remain for a time on the main screen. They are annotated with the time that the measurement was made to distinguish them from continuously measured values. Making an Automatic Measurement Select Repeat or Repeat Time and select the required interval between measurements. In the Setup SpO menu, select Start SpO, or use the Start SpO SmartKey. When automatic mode is selected, to make a measurement:
1 2 You can start a manual measurement between automatic measurements, if required, by selecting Start SpO again as described above. To end an automatic series of measurements, change the measurement mode to Manual or Continuous. Understanding SpO2 Alarms This refers to SpO2 specific alarms. See the Alarms chapter for general alarm information. SpO2 offers high and low limit alarms, and a high priority desat alarm. You cannot set the low alarm limit below the desat alarm limit. 176 10 Monitoring SpO2 CAUTION If you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO2 INOP can occur. To avoid this, the monitor can be configured to suppress corresponding SpO2 INOPs when it detects an inflated cuff (for FAST SpO2 technology only). If INOPs are suppressed, there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia. Alarm Delays There is a delay between a change in the oxygen saturation at the measurement site and the corresponding alarm indication at the monitor. This delay has two components:
The general measurement delay time is the time between the occurrence of the saturation change and when the new value is represented by the displayed numerical values. This delay depends on the algorithmic processing and the averaging time configured for SpO2. The longer the averaging time configured, the longer the time needed until the numerical values reflect the change in saturation. The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay is the sum of the alarm delay time configured for SpO2, plus the system alarm delay. The system alarm delay is the processing time the system needs for any alarm to be indicated on the monitor, after the measurement has triggered the alarm. See Monitor Performance Specifications on page 293 for the system alarm delay specification. For SpO2 high and low limit alarms, there are two different types of alarm delay time. The standard alarm delay is set to a fixed value. The Smart Alarm Delay varies, based on an intelligent algorithm, and can be used instead of the standard alarm delay. The Desat alarm always uses the standard alarm delay. Standard Alarm Delay The standard alarm delay time can be configured to a fixed value between 0 and 30 seconds, in 1 second steps. Smart Alarm Delay The Smart Alarm Delay feature tries to reduce "nuisance" alarms. WARNING Before using Smart Alarm Delays, make sure that you fully understand how the delay is applied and what the consequences are. How Does it Work?
The monitor assesses the severity of a limit violation by looking at its magnitude and duration, and can delay the alarm, depending on the assessed severity. Examples for the delay are given in the table in the example below. 177 10 Monitoring SpO2 Clinical Example You are monitoring a patient with a low SpO2 limit of 90%. Then, while sleeping, your patient drops to 89% for 20 seconds, and then recovers. The Smart Alarm Delay would tolerate this limit violation up to 50 seconds (upper shaded cell in the table) before issuing an SpO2 low alarm. So in this case there would be no alarm notification. If the SpO2 drops further (e.g. to 85%), the tolerance time is much lower (10 seconds, see lower shaded cell). Actual deviation from violated alarm limit Resulting alarm notification delay according to selected mode Short Medium Long 25 sec (maximum delay) 50 sec (maximum delay) 100 sec (maximum delay) 12 sec 10 sec (minimum delay) 10 sec 10 sec 10 sec 10 sec 10 sec 10 sec 10 sec 25 sec 16 sec 12 sec 10 sec (minimum delay) 10 sec 10 sec 10 sec 10 sec 10 sec 50 sec 33 sec 25 sec 20 sec 16 sec 14 sec 12 sec 11 sec 10 sec (minimum delay) Table with Detailed Delays for Specific Limit Violations In the clinical example above, the Medium delay mode has been selected. For less stable or more robust patients, the tolerance time can be adjusted using Short or Long mode. 1%
2%
3%
4%
5%
6%
7%
8%
9%
>9%
178 Smart Alarm Delay Dynamics
% SpO2 10 Monitoring SpO2 low limit desat limit time (s) 1 2 First trigger point - with the smart alarm delay setting "medium", the low alarm is triggered 12 seconds after the SpO2 value has fallen below the low limit. A - ** SpO Low alarm Second trigger point - with zero desat delay, the alarm is triggered as soon as the SpO2 value falls below the desat limit. B - *** Desat alarm As long as the SpO2 value stays in the shaded zone, the low alarm is delayed. Setting Smart Alarm Delay Mode To set the mode for Smart Alarm Delays, in the Setup SpO menu:
1 Check that SmartAlarmDelay is set to On. This setting is made in Configuration Mode and will be shown in the menu in gray. If it is set to Off, a standard alarm delay is in use. Select High Alarm Delay and choose Short, Medium, or Long mode. Select Low Alarm Delay and choose Short, Medium, or Long mode. 2 3 If you also use monitors with earlier software revisions, be aware that smart alarm delays will not be used after a transfer to one of these monitors. Monitors with earlier software revisions will always use the standard alarm delay. If you are not sure whether a monitor has the Smart Alarm Delay function, check whether there is a SmartAlarmDelay entry in the Setup SpO menu. 179 10 Monitoring SpO2 Smart Alarm Delay Indicator If the Smart Alarm Delay is switched on, a special indicator will be displayed next to the SpO2 alarm limits. This indicator consists of a general alarm symbol with three blocks above and below it. Indicator Indicator with Numerics The blocks above and below the alarm symbol indicate which Smart Alarm Delay modes have been set:
Short Medium Long The blocks above the alarm symbol show the delay mode for the high limit, and the blocks below for the low limit. When the SpO2 value crosses an alarm limit, the delay period starts. During the delay period, the symbol is highlighted to indicate that an alarm limit has been violated:
If the SpO2 value returns inside the limits during the delay period, the highlighting will be removed and no alarm is indicated. If the SpO2 value is still outside the alarm limit at the end of the delay period, the alarm is indicated and the highlighting will be removed from the symbol. Adjusting the Alarm Limits In the Setup SpO menu:
Touch the high limit on the alarm limits menu button. Choose the high alarm limit from the pop-
up list that opens. Touch the low limit on the alarm limits menu button. Choose the low alarm limit from the pop-up list that opens. WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high alarm off. 180 10 Monitoring SpO2 Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. 1 2 Adjust the limit. In the Setup SpO menu, select Desat Limit. Pleth Wave The Pleth wave is autoscaled to maximum display size. It decreases only when the signal quality becomes marginal. It is NOT directly proportional to the pulse volume. If you need an indication of change in pulse volume, use the perfusion indicator. 1 Minimum size for reliable SpO2 value Perfusion Numeric The perfusion numeric (Perf) gives a value for the pulsatile portion of the measured signal caused by the pulsating arterial blood flow. As pulse oximetry is based on the pulsatile nature of the signal, you can also use the perfusion numeric as a quality indicator for the SpO2 measurement. Above 1 is optimal, between 0.3-1 is acceptable. Below 0.3 is marginal; reposition the sensor or find a better site. Perfusion Change Indicator The perfusion change indicator is a graphic symbol which shows the change in the perfusion value, relative to a reference value which you can set. To set the current perfusion value as the reference value:
When a reference value has been set, the perfusion change indicator is displayed next to the perfusion numeric. In the Setup SpO menu, select Set Perf Ref.. Setting SpO2/Pleth as Pulse Source 1 2 In the Setup SpO menu, select Pulse (SpO) to enter the Setup Pulse menu. In the Setup Pulse menu, select Syst.Pulse and select SpO from the pop-up list. 181 10 Monitoring SpO2 Setting Up Tone Modulation If tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops. Remember, the QRS tone is derived from either heart rate or pulse depending on which is currently selected as the active alarm source. In the Setup SpO menu, select Tone Mod. to switch between Yes (for on) and No (for off). Setting the QRS Volume In the Setup SpO menu, select QRS Volume and set the appropriate QRS tone volume. 182 11 11Monitoring NBP This monitor uses the oscillometric method for measuring NBP. In adult and pediatric mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial or auscultatory measurements
(depending on the configuration) in a representative patient population. For the auscultatory reference, the fifth Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10-1992) in relation to mean error and standard deviation, when compared to intra-arterial measurements in a representative patient population. The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 601-2-30:1999/EN 60601-2-30:2000. A physician must determine the clinical significance of the NBP information. Introducing the Oscillometric NBP Measurement Oscillometric devices measure the amplitude of pressure changes (oscillations) in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. WARNING Patient Category: Select the correct patient category setting for your patient. Do not apply the higher adult inflation, overpressure limits and measurement duration to neonatal patients. Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Existing Wounds: Do not apply the cuff over a wound as this can cause further injury. 183 11 Monitoring NBP Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the the benefit of the measurement outweighs the risk. Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff. Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb. CAUTION If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. Measurement Limitations NBP readings can be affected by the position of the patient, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information. Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible:
with excessive and continuous patient movement such as shivering or convulsions with rapid blood pressure changes with severe shock or hypothermia that reduces blood flow to the peripheries with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias the artery on an edematous extremity. Measurement Modes There are four modes for measuring NBP:
Manual - measurement on demand. Auto - continually repeated measurements (between one minute and 24 hours adjustable interval). Sequence - up to four measurement cycles which will run consecutively, with number of measurements and interval between them configurable for each cycle. STAT - rapid series of measurements over a five minute period, then the monitor returns to the previous mode. Use only on supervised patients. 184 11 Monitoring NBP Reference Method The measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For further information, see the Application Note supplied on the monitor documentation DVD. In Neonatal mode, to comply with safety standards, invasive is always used as the reference method. This setting cannot be changed and is not visible in any operating mode. In Adult and Pediatric mode, to check the current setting, select Main Setup, Measurements, then NBP, and check whether the Reference setting is set to Auscult. or Invasive. This setting can only be changed in Configuration Mode. Preparing to Measure NBP 1 Connect the cuff to the air tubing. 2 Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. WARNING Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient. 3 Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the cover is not folded or twisted. A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part of the cuff should be long enough to encircle at least 80% of the limb. 4 Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement correction formula to correct the measurement. The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. WARNING Inspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or stat measurements. Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level, to the displayed value Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or lower. 185 11 Monitoring NBP Recommendations For Measurements Used in Diagnosis of Hypertension To make a measurement for use in the diagnosis of hypertension, follow the steps below:
1 Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor and back and arm supported. 2 Ask the patient to relax and not talk before and during the measurement. 3 If possible, wait 5 minutes before making the first measurement. Understanding the NBP Numerics 1 Alarm source 2 Measurement Mode 3 Timestamp/Timer 4 Mean pressure 5 Diastolic 6 Systolic 7 Alarm limits Depending on the NBP numeric size, not all elements may be visible. Your monitor may be configured to display only the systolic and diastolic values. If configured to do so, the pulse from NBP will display with the NBP numeric. The measured NBP value, together with the corresponding pulse rate if this is switched on, will be displayed for one hour. After that the values are regarded as invalid and are no longer displayed. During this hour, measurement values may be grayed out or disappear from the screen after a set time, if configured to do so. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration mode. In Auto mode the measurement values may disappear more quickly (to be replaced by new measurement values), if the repeat time is set to less than one hour. Alarm Sources If you have parallel alarm sources, the sources are displayed instead of the alarm limits. NBP Timestamp Depending on your configuration, the time shown beside the NBP numeric can be:
the time of the most recent NBP measurement, also known as the "timestamp", or the time until the next measurement in an automatic series, displayed with a graphic representation of the remaining time, as shown here. 186 11 Monitoring NBP The NBP timestamp will normally show the completion time of the NBP measurement. Only under the following conditions the timestamp shows the beginning of the measurement:
when in Auto or Sequence mode, and the monitor is configured to synchronize the measurements in a measurement series to an "easy-
to-document" time. For example, if you start the first measurement at 08:23, and the Repeat Time is set to 10 minutes, the monitor automatically performs the next measurement at 8:30, then 8:40 and so on. During Measurements The cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you a preliminary indication of the systolic blood pressure during measurement. When Unexpected Values are Measured When values measured are higher or lower than expected, check the following potential causes:
Possible Cause The patient was talking or moving before or during the measurement. The incorrect cuff size was used or the cuff was not at heart level The noninvasive blood pressure reference method is set incorrectly. Solution Allow the patient to rest quietly, then try again after three to five minutes. Check the cuff size, level, and position then repeat the measurement. Check the reference method (auscultation or intra-
arterial) in the Setup NBP menu. If it is incorrect, have it changed in Configuration Mode. Check the list in Measurement Limitations on page 184. Measurement limitations have not been taken into account. Starting and Stopping Measurements Use the Setup NBP menu or SmartKeys to start and stop measurements. Action to be performed Start manual measurement Start Auto series NBP Setup menu Start/Stop SmartKeys Start STAT measurement NBP STAT Start/ Stop Start NBP NBP STAT Start STAT 187 11 Monitoring NBP Action to be performed Stop Manual measurements NBP Setup menu Start/Stop SmartKeys Stop current Auto measurement Start/Stop Stop current STAT measurement and end series Start/Stop NBP STAT Stop Auto, Manual or STAT measurement AND series Stop All Start/ Stop Stop NBP Start/ Stop Stop NBP Start/ Stop NBP STAT Stop NBP Stop All CAUTION Use clinical judgment to decide whether to perform repeated series of STAT measurements because of the risk of purpura, ischemia and neuropathy in the limb with the cuff. Enabling Automatic Mode and Setting Repetition Time 1 2 In the Setup NBP menu, select Mode and select Auto from the pop-up menu. For an automatic measurement, select Repeat and set the time interval between two measurements. 188 Enabling Sequence Mode and Setting Up The Sequence 11 Monitoring NBP 1 2 3 In the Setup NBP menu, select Mode and select Sequence from the pop-up menu. Select Setup Sequence to open the Setup Sequence window. Up to four measurement cycles can be set up which will run consecutively. For each cycle you can set the number of measurements and the interval between them. If you want to run less than four cycles in a sequence, you can set the number of measurements for one or more cycles to Off. Select each sequence in turn and select the number of measurements and the time interval between the measurements. 4 To have measurements continue after the sequence, set the number of measurements for your last cycle to Continuous and this cycle will run indefinitely. CAUTION Be aware that, if none of the cycles are set to Continuous, NBP monitoring will end after the last measurement of the cycle. When the NBP measurement mode is set to Sequence, the repetition time for Auto mode cannot be changed. Choosing the NBP Alarm Source You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. In the Setup NBP menu, select Al. from and choose from:
Menu option Sys. Dia. Mean Sys & Dia Dia & Mean Sys & Mean Sys&Dia&Mean Pressure value monitored systolic diastolic mean systolic and diastolic in parallel diastolic and mean in parallel systolic and mean in parallel all three pressures in parallel If Mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived an NBP Measure Failed INOP will be displayed. 189 11 Monitoring NBP Switching Pulse from NBP On/Off In the process of making the NBP measurement, a pulse value can be derived and displayed. The pulse value is displayed together with the time the measurement was made. After one hour the value becomes invalid. There are no alarms associated with pulse from NBP. When the accelerated measurement is in use, no pulse value can be derived. To switch the display of the pulse value on or off:
In the Setup NBP menu select Pulse (NBP). Assisting Venous Puncture In the Setup NBP menu select VeniPuncture. Puncture vein and draw blood sample. You can use the NBP cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time (adult/pediatric 170 seconds, neonatal 85 seconds) if you do not deflate it. 1 2 3 Reselect VeniPuncture to deflate the cuff. During measurement, the NBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. NOTE Performing a venous puncture while automatic or sequence NBP measurements are being made suspends the measurement series for the duration of the venous puncture inflation and for three minutes afterwards. Calibrating NBP NBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary. See the Service Guide for details. 190 12 12Monitoring Temperature WARNING Measurements from an MMS extension connected to the monitor are not available when the monitor is running on its own battery power. They are only available when the monitor is powered by the external power supply (M8023A) or the Battery Extension (865297). You can measure temperature using the built-in temperature measurement (optional), or one of the MMS extensions. The Temp measurement automatically switches on when you connect a probe. You can switch the measurement off manually. The displayed temperature is the temperature measured directly at the measurement site. No predictions or adjustments are made (direct mode thermometer). Making a Temp Measurement Select the correct type and size of probe for your patient. If you are using a disposable probe, connect the probe to the temperature cable. Plug the probe or temperature cable into the temperature connector socket. 1 2 3 4 Apply the probe to the patient. You are advised to use a protective rubber cover on rectal probes. 5 6 Check that the alarm settings (on or off, high and low limits) are appropriate for this patient and Select an appropriate temperature label. this type of temperature measurement. WARNING Make sure you set alarm limits for the correct label. The alarm limits you set are stored for that particular label only. Changing the label may change the alarm limits. 191 12 Monitoring Temperature Selecting a Temperature for Monitoring Tell the monitor which temperature you want to monitor by selecting its temperature label. The label is a unique identifier for each type of temperature. When you choose a label, the monitor uses that label's stored color and alarm settings. 1 2 In the Setup <Temp Label> menu, select Label. Select the appropriate label from the list. Temp Tart Tcore Tesoph non-specific temperature label arterial temperature core temperature esophageal temperature Trect Tskin Tven Tnaso rectal temperature skin temperature venous temperature nasopharyngeal temperature Extended Temperature Label Set The following additional labels are available if Label Set is set to Full. This setting can only be changed in Configuration Mode. Note that if your monitor is connected to an Information Center, the additional labels in the extended label set may not be correctly displayed. See the Configuration Guide for your monitor for more information. T1, T2, T3, T4 Tamb Tcereb Ttymp Tvesic Non-specific temperature labels ambient temperature cerebral temperature tympanic temperature vesical temperature Calculating Temp Difference The monitor can calculate and display the difference between two temperature values by subtracting the second value from the first. The difference is labeled Temp. 1 2 3 4 5 6 In the Main Setup menu, select Measurements. Select Temp. In the Setup Temp menu, select First Temp. Select the appropriate label for the measurement source. Select Second Temp. Select the appropriate label for the second measurement source. 192 13 13Monitoring Invasive Pressure WARNING Measurements from an MMS extension connected to the monitor are not available when the monitor is running on its own battery power. They are only available when the monitor is powered by the external power supply (M8023A) or the Battery Extension (865297). CAUTION Do not use a monitor with an M1006A pressure module as an additional monitor for your patient. This may cause interference on the respiration or invasive pressure measurements. You can measure pressure using the monitor's built-in pressure measurement (optional), or one of the MMS extensions. Setting up the Pressure Measurement 1 2 3 Plug in the pressure cable. Prepare the flush solution. Flush the system to exhaust all air from the tubing. Ensure that the transducer and stopcocks are free of air bubbles. WARNING If air bubbles appear in the tubing system, flush the system with the infusion solution again. Air bubbles may lead to a wrong pressure reading. 4 Connect the pressure line to the patient catheter. 5 If you are using an infusion pressure cuff with the pressure line, attach the pressure cuff to the fluid to be infused. Inflate it according to your standard hospital procedure, then start the infusion. Position the transducer so that it is level with the heart, approximately at the level of the midaxillary line. 6 193 13 Monitoring Invasive Pressure WARNING If measuring intracranial pressure (ICP, IC1 or IC2) with a sitting patient, level the transducer with the top of the patient's ear. Incorrect leveling may give incorrect values. Selecting a Pressure for Monitoring Tell the monitor the source of the pressure you want to monitor by selecting an appropriate pressure label. The label is a unique identifier for each type of pressure. When you choose a label, the monitor uses that label's stored settings, for example color, wave scale and alarm settings. The label also determines which algorithm is used to process the pressure signal, so an incorrect label can lead to incorrect pressure values. 1 2 In the Setup <Press Label> menu, select Label. Select the appropriate label from the list. Label ABP ART Ao CVP ICP LAP P PAP RAP UAP UVP Description Arterial blood pressure Arterial blood pressure (alternative) Aortic pressure Central venous pressure Intracranial pressure Left atrial pressure Non-specific pressure label Pulmonary artery pressure Right atrial pressure Umbilical arterial pressure Umbilical venous pressure Extended Pressure Label Set The following additional labels are available if Label Set is set to Full. This setting can only be changed in Configuration Mode. Note that if your monitor is connected to an Information Center, the additional labels in the extended label set may not be correctly displayed. See the Configuration Guide for your monitor for more information. Label BAP FAP IC1, IC2 P1, P2, P3, P4 Description Brachial arterial pressure Femoral arterial pressure Alternative intracranial pressures Alternative non-specific pressure labels 194 Overview of Calibration Procedures 13 Monitoring Invasive Pressure Calibration requirements depend on the situation and the type of transducer used. Recommendations for the different calibration procedures are given in the table below. Procedure When to perform For which transducers?
Disposable X Reusable X Zero Every time you use a new or a different transducer or tubing Every time you reconnect the transducer to the monitor If you think the monitor's pressure readings are not correct Calibration Every time you use a new or a different transducer Adjust calibration factor According to your hospital policy Can be done instead of the calibration procedure when a calibration factor is marked on your reusable transducer Zeroing the Pressure Transducer X X To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy. You must perform a zero:
when you use a new transducer or tubing if you think the monitor's pressure readings are not correct. every time you reconnect the transducer cable to the monitor Zeroing ICP (or IC1/IC2) Your hospital guidelines may require you to zero the ICP transducer less frequently than other transducers, due to the need for aseptic conditions. When you zero an ICP transducer, the zero values are automatically stored and you will not be prompted to repeat the zero procedure. If you want to simultaneously zero all pressures except ICP, disconnect the ICP transducer from the monitor while zeroing. Reconnecting the transducer recalls the stored values. WARNING If you select the label ICP (or IC1/IC2), the measurement device uses the most recently stored zero. Therefore, make sure you zeroed the transducer correctly in accordance with the transducer manufacturer's instructions and your hospital policy. When you use a transducer that you cannot rezero after placement, ensure that you keep the measuring device with the patient so that you are certain you have the correct zero data for this patient. 195 13 Monitoring Invasive Pressure Determining a Pressure's Most Recent Zero The monitor displays the most recent zero on the status line. If this has "timed-out" after you have performed a zero, redisplay the information in the status line by entering the pressure's setup menu. Zeroing a Pressure Measurement WARNING Invasive pressure alarms (and pulse alarms, if derived from invasive pressure) are temporarily suppressed until 30 seconds after the transducer finishes zeroing. Turn off the stopcock to the patient. 1 2 Vent the transducer to atmospheric pressure, to compensate for the static and atmospheric pressure exerted on the transducer. In the setup menu for the pressure, select Zero <Press Label>. 3 4 When you see the message <Press Label> zero done at <Date and Time> on the status line, close the stopcock to atmospheric pressure, and open the stopcock to the patient. CAUTION When using high frequency ventilation, ensure that the tubing from the ventilator does not touch the arterial line, or connect with it indirectly, while zeroing the pressure. This could cause small pressure variations which can interfere with the zero procedure. Zeroing All Pressures Simultaneously WARNING Before zeroing all pressures, make sure that all pressure transducers are vented to atmospheric pressure. If you are measuring pressures with more than one measuring device, using the Zero Press SmartKey to initiate the zeroing calls up a list of all active pressures. Select the pressure you want to zero or select All Press to zero all pressures simultaneously. Troubleshooting the Zero The status line lists the probable cause of an unsuccessful zero:
Message
<Press Label> can't zero;
equipment malf.
<Press Label> can't zero;
excessive offset
<Press Label> can't zero
- unstable signal Corrective Action The hardware is faulty. Contact your service personnel. Make sure the transducer is vented to air and try again. If this fails, the hardware may be faulty. Replace the adapter cable and try again. If it fails, replace the transducer and try again. If it still fails, contact your service personnel. 196 13 Monitoring Invasive Pressure Message
<Press Label> can't zero
- no transducer
<Press Label> can't zero;
pulsat. pressure
<Press Label> unable to zero - timed out Switch <Press Label> on first Corrective Action Make sure that the transducer is connected and try again. If this fails, exchange the adapter cable and try again. If this fails, exchange the transducer. Make sure that the transducer is vented to air, not to the patient, and try again. Try pressing the Zero key again. If this fails, replace the transducer and adapter cable and contact your service personnel. Pressure measurement is switched off. To switch it on, in the Setup Pressure menu, select the pressure's label. Calibrating Reusable Transducers Depending on your monitor's configuration, you may be able to perform a calibration in monitoring mode. Perform a mercury calibration when you use a new transducer, and at regular intervals according to your hospital policy. You require:
standard sphygmomanometer. sterile 10cc syringe with heparinised solution. 3-way stopcock. approximately 25 cm of tubing. NOTE Only reusable transducers must be calibrated. Making the Pressure Calibration WARNING Never perform the invasive pressure calibration while a patient is being monitored. 1 Zero the transducer. 2 Connect the syringe and manometer. a. Attach the tubing to the manometer. b. Connect the 3-way stopcock to the stopcock that is not connected to the patient catheter when you measure a patient. c. Attach the syringe to one port and the manometer tubing to the other port. d. Open the port to the manometer. 197 13 Monitoring Invasive Pressure 1 Tubing to manometer 2 Syringe with heparinised solution 3 To pressure connector on monitor 4 Patient connection stoppered 5 Off 3 Move the syringe barrel in and raise the mercury to 200 mmHg (30 kPa). 200 mmHg is the recommended calibration pressure. In the Setup <Press Label> menu, select Cal. Press. Select the calibration pressure from the list, for example 200 mmHg. Select Confirm to recalculate the calibration factor using the applied pressure. 4 5 6 7 When the monitor displays <Press Label> mercury calibr. done at <Date and Time>, remove the manometer tubing, syringe and extra stopcock. We recommend you replace the transducer dome and tubing with sterile ones. Label the transducer with the calibration factor shown in the Cal. Factor field in the pressure's setup menu. 8 9 Reconnect the patient and start measuring again. Troubleshooting the Pressure Calibration The status line lists the probable cause of an unsuccessful calibration. Message
<Press Label> can't calibr.; equipmt malf.
<Press Label> can't calibrate;out of range
<Press Label> can't calibrate; no transd. Corrective Action Contact your service department. The pressure hardware is faulty. Make sure that you have selected the value for Cal. Press that you are applying to the transducer, and repeat the calibration. Make sure that the transducer is connected and try again. 198 13 Monitoring Invasive Pressure Message
<Press Label> can't cal.; unstable signal
<Press Label> can't calibr.;do zero first Corrective Action Make sure there are no disturbances to the transducer, and repeat the calibration. No valid zero. Zero the transducer. Adjusting the Calibration Factor Each time you use a reusable transducer, compare the calibration factor written on your transducer with the calibration factor shown on the monitor. To ensure accurate measurement, they must be the same. 1 In the Setup <Press Label> menu, select Cal. Factor. If the value here does not match that on the transducer, select the corresponding value from the list, in accordance with your hospital's procedure. 2 To confirm you want to use the new calibration factor, select the Confirm pop-up key. Displaying a Mean Pressure Value Only Use this when you want to see only the mean pressure. In the pressure's setup menu, select Mean only. Toggle between On to display mean pressure value only, and Off to display all pressure values (systolic, diastolic and mean). Changing the Pressure Wave Scale 1 2 3 Select the label of the pressure wave whose scale you want to set to enter the Setup <Press Label>
menu. In the Setup <Press Label> menu, (for example ABP) select Scale. Select a value from the pop-up list:
a positive value sets the top gridline. The bottom gridline is set at zero. a negative value sets the bottom gridline. The middle gridline is set at zero. Optimizing the Waveform In the Setup <Press Label> menu, select Optimum Scale to let the monitor select the best minimum and maximum scales for the current wave. Non-Physiological Artifact Suppression Some clinical procedures may affect blood pressure, for example, a flush procedure or a blood sample. Your monitor may be configured to suppress these non-physiological artifacts for a specified duration
(Artifact Suppr. is configured to 30 sec, 60 sec, or 90 sec). During artifact suppression, the monitor shows the INOP message <Press Label> Artifact, and a question mark is shown beside the pressure numerics. Pressure alarms and the <Press Label> No Pulse INOP are suppressed during the configured period. The CPP alarms are not suppressed. 199 13 Monitoring Invasive Pressure Choosing the Pressure Alarm Source WARNING Make sure you set alarm limits for the correct label. The alarm limits you set are stored for that particular label only. Changing the label may change the alarm limits. You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. Only one alarm is given at a time, in this order of priority: mean, systolic, diastolic. In the Setup <Press Label> menu, select Al. from and choose the source. Menu option Sys. Dia. Mean Sys & Dia Dia & Mean Sys & Mean Sys&Dia&Mean Pressure value monitored systolic diastolic mean systolic and diastolic in parallel diastolic and mean in parallel systolic and mean in parallel all three pressures in parallel Select and set the High Limit and Low Limit for the pressure(s) you have selected. Extreme Alarm Limits for Pressure The extreme pressure alarms, Extreme High and Extreme Low, can be made available for your monitor in Configuration Mode and are additional to the standard High and Low limit alarms. They are generated by the active pressure alarm source, and are setup in Configuration Mode by adding a set value (the value) to the high and low alarm limits. This value can be set for each pressure label individually. 1 Extreme Low Limit 2 Low Limit 3 High Limit 4 Extreme High Limit 5 Extreme Low 6 Extreme High 200 13 Monitoring Invasive Pressure You need to know which values have been configured for your monitor. Changing the high and low alarm limits automatically changes the extreme alarm limits within the allowed range. To see the extreme pressure alarms set for your monitor, in the setup menu for that pressure, see the menu items Extr.High and Extr. Low. The extreme pressure alarms are high priority, red alarms, marked *** in the alarm message. Calculating Cerebral Perfusion Pressure The monitor can calculate the difference between mean arterial pressure and the intracranial pressure. The difference is labeled CPP. 1 2 3 In the Main Setup menu, select Measurements. Select CPP. In the Setup CPP menu, select which arterial pressure source should be used in the calculation. 201 13 Monitoring Invasive Pressure 202 14 14Monitoring Carbon Dioxide WARNING Measurements from an MMS extension connected to the monitor are not available when the monitor is running on its own battery power. They are only available when the monitor is powered by the external power supply (M8023A) or the Battery Extension (865297). CAUTION Only one CO2 measurement at a time is supported. Use the CO2 measurement to monitor the patient's respiratory status and to control patient ventilation. There are two methods for measuring carbon dioxide in the patient's airway:
Mainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted into the patient's breathing system. This method is available using the monitor's built-in CO2 measurement (optional) or the M3014A Capnography Extension. Sidestream measurement takes a sample of the respiratory gas with a constant sample flow from the patient's airway and analyzes it with a remote CO2 sensor. You can measure sidestream CO2 using the monitor's built-in CO2 measurement (optional) or using the M3014A Capnography Extension, or the M3015A/B Microstream CO2 Extension. WARNING Correlation: The etCO2 readings do not always correlate closely with paCO2, especially in neonatal patients and patients with pulmonary disease, pulmonary embolism or inappropriate ventilation. Pharmaceuticals in aerosols: Do not measure CO2 in the presence of pharmaceuticals in aerosols. Explosion Hazard: Do not use in the presence of flammable anesthetics or gases, such as a flammable anesthetic mixture with air, oxygen or nitrous oxide. Use of the devices in such an environment may present an explosion hazard. Failure of operation: if the measurement or a sensor fails to respond as described, do not use it until the situation has been corrected by qualified personnel. 203 14 Monitoring Carbon Dioxide Low etCO2 values: Leakages in the breathing system or sampling system may cause the displayed etCO2 values to be significantly too low. Always connect all components securely and check for leaks according to standard clinical procedures. Displacement of the nasal or combined nasal oral cannulas can cause lower than actual etCO2 readings. Even with combined nasal oral cannulas, the etCO2 readings may be slightly lower than actual in patients breathing through the mouth only. Measurement Principles For both mainstream and sidestream measurements, the measurement principle is infrared transmission, where the intensity of infrared light passing the respiratory gas is measured with a photo detector. As some of the infrared light is absorbed by the CO2 molecules, the amount of light passing the gas probe depends on the concentration of the measured CO2. When using a wet ventilator circuit, monitor mainstream CO2 if available, in preference to sidestream CO2. The partial pressure is calculated from the gas concentration by multiplying the concentration value with the ambient pressure. The measurement provides:
a CO2 waveform. an end tidal CO2 (etCO2) value: the CO2 value measured at the end of the expiration phase. an inspired minimum CO2 (imCO2): the smallest value measured during inspiration. an airway respiration rate (awRR): the number of breaths per minute, calculated from the CO2 waveform. Depending on the Max Hold setting configured for your monitor, the etCO2 numeric shows either the highest CO2 value measured within the configured time period (Max Hold set to 10 sec or 20 sec) or the etCO2 numeric shows breath-to-breath value (Max Hold set to Off). The Microstream method also provides an Integrated Pulmonary Index (IPI) numeric, which is an indication of the patient's overall ventilatory status based on four measurement parameters: etCO2, awRR, pulse rate and SpO2. IPI can thus provide an early indication of a change in ventilatory status which may not be shown by the current value of any of these four parameters individually. The IPI is designed to provide additional information regarding patient status, possibly before etCO2, awRR, SpO2, or pulse rate values reach levels of clinical concern. The IPI is available for all three groups of pediatric patients (1-3 years, 3-6 years, and 6-12 years), and for adult patients. It is displayed as a single value between 1 and 10. Availability of the SpO2 and pulse values for the IPI calculation is not affected by the labels used or the SpO2 technology in the monitor. 204 14 Monitoring Carbon Dioxide Measuring CO2 using the CO2 Option or M3014A The monitor (with the CO2 option) or the M3014A Capnography Extension measures partial pressure of carbon dioxide in a patient's expired gas using the mainstream method or the sidestream method. The mainstream CO2 measurement can be used, with appropriate accessories, with intubated adult, pediatric and neonatal patients. The sidestream CO2 measurement can be used, with appropriate accessories, with intubated and non-intubated adult, pediatric, infant and neonatal patients. With intubated patients, a sample of the respiratory gas is drawn from the patient's breathing circuit through an airway adapter and a gas sampling tube. With non-intubated patients, the gas sample is drawn through a nasal or oral-nasal cannula. WARNING Altitude Setting: The monitor is not equipped with automatic barometric pressure compensation. Before the CO2 measurement is used for the first time, the altitude must be set to the correct value. An incorrect altitude setting will result in incorrect CO2 readings. The CO2 readings will typically deviate 5% for every 1000 m difference. CAUTION Use the CO2 measurement with Philips approved accessories only. Refer to the instructions for use provided with the accessory. Preparing to Measure Mainstream CO2 You must perform a zero as described in this procedure each time you use a new airway adapter. 1 Attach the sensor connector to the CO2 connector on the monitor (when the optional CO2 measurement is integrated) or on the extension. 2 Wait 2 minutes, allowing the sensor to reach its operating temperature and a stable thermal condition. 3 Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly. 205 14 Monitoring Carbon Dioxide 4 Zero the sensor:
Expose the sensor to room air and keep it away from all sources of CO2 including the ventilator, the patient's breath and your own. In the setup menu for the CO2, select Start Zero Cal. When you see the message CO calibration done at <Date and Time> on the status line, the zero calibration is finished and you can begin monitoring. 5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y-
section. WARNING To prevent stress on the endotracheal tube, support the sensor and airway adapter. Position sensor cables and tubing carefully to avoid entanglement or potential strangulation. Do not apply excessive tension to any cable. Replace the airway adapter, if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status. To avoid infection, use only sterilized, disinfected or disposable airway adapters. Inspect the airway adapters prior to use. Do not use if airway adapter appears to have been damaged or broken. Observe airway adapter color coding for patient population. Preparing to Measure Sidestream CO2 1 Plug the sensor cable into the monitor's CO2 input connector. Allow the sensor two minutes warm up time 206 2 Connect the cannula, airway adapter, or sample line as appropriate, to the sensor. It will click into place when seated correctly. 14 Monitoring Carbon Dioxide 3 To zero the sensor:
expose the sensor to room air and keep it away from all sources of CO2 including the ventilator, the patient's breath and your own. in the setup menu for the CO2, select Start Zero Cal. when you see the message CO calibration done at <Date and Time> on the status line, the zero calibration is finished and you can begin monitoring. 4 For intubated patients requiring an airway adapter: Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y-section. For intubated patients with an integrated airway adapter in the breathing circuit: Connect the male luer connector on the straight sample line to the female port on the airway adapter. For non-intubated patients: Place the nasal cannula onto the patient. For patients prone to mouth breathing use an oral-nasal cannula. For nasal or oral-nasal cannulas with oxygen delivery, place the cannula on the patient as shown then attach the oxygen supply tubing to the oxygen delivery system and set the prescribed oxygen flow. 207 14 Monitoring Carbon Dioxide WARNING Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit. In reverse, always remove the airway adapter from the breathing circuit before removing the sensor. Make sure that you do not accidentally connect the luer connector of the gas sample line to an infusion link or any other links in the patient vicinity. CAUTION Always disconnect the cannula, airway adapter or sample line from the sensor when not in use. Using the Sidestream Sensor Holder The holder delivered with the sensor can be used to clamp the sensor onto an IV pole or a shelf. Push the sensor into the holder until it clicks into position. 1 2 Clamp the holder onto an IV pole, a shelf or another appropriate location. To remove the sensor from the holder, release the clip and pull the sensor out of the holder. Removing Exhaust Gases from the System WARNING Anesthetics: When using the sidestream CO2 measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, to avoid exposing medical staff to anesthetics. Patient cross-infection: Do not return the sampled gas to the breathing system of the patient. Make sure that you do not accidentally connect the exhaust tube to an infusion link or any other links in the patient vicinity. Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the sidestream sensor at the outlet connector. 208 Measuring Microstream CO2 using M3015A/B 14 Monitoring Carbon Dioxide The M3015A/B Microstream CO2 Extension measures the partial pressure of carbon dioxide in a patient's expired gas using Microstream technology. The measurement is equipped with an automatic barometric pressure compensation. WARNING When using the IPI numeric (available for adult and pediatric patients), always ensure that the patient's date of birth is entered correctly and that the monitor is displaying the current date. These two pieces of information are used to calculate the age of the patient, which affects the algorithm used to provide the IPI numeric. Preparing to Measure Microstream CO2 Use appropriate accessories for:
All accessories are for single patient use only. the patient type (adult, pediatric or neonatal), the ventilation situation (including humidification) the duration - short term use, up to 24 hours (typically OR), or long term use (typically ICU). Using Microstream Accessories The Microstream measurement can be operated with the special Microstream accessories only. Refer to the instructions for use provided with the accessory. For intubated patient with non-humidified ventilation, you can use a Microstream FilterLine set. For humidified ventilation, use a FilterLine H Set. For non-intubated patients, the gas sample is taken through a Nasal FilterLine, or a Smart CapnoLine
(which is a combined oral-nasal FilterLine). In parallel to the measurement of the CO2, oxygen (O2) may be delivered to the patient to support gas exchange. This is done by using an O2/CO2 FilterLine, or a Smart CapnoLine O2 (a combined oral-nasal O2/CO2 FilterLine). Using the FilterLine and Airway Adapter WARNING Make sure that you do not accidentally connect the luer connector of the gas sample line to an infusion link or any other links in the patient vicinity. 1 Attach the female Luer connector to the CO2 inlet connector by pushing the socket cover aside and screwing the connector clockwise into the CO2 inlet until it can no longer be turned. This will assure that there is no leak of gases at the connection point during measurement and that measurement accuracy is not compromised. Following connection of the CO2 sampling line, check that CO2 values appear on the monitor display. 2 Check that the FilterLine is not kinked. 209 14 Monitoring Carbon Dioxide 3 Change the FilterLine if a CO Occlusion INOP appears on the monitor or if the readings become extremely erratic. Disconnect the FilterLine during suctioning and nebulizing therapies or suppress sampling by turning off the pump as described in Suppressing Sampling (not Mainstream CO2) on page 211. Check the table in the Microstream CO2 Accessories section of the Accessories chapter for typical usage times for the different Microstream accessories. CO2 values for non-intubated patients using Microstream accessories will always tend to be lower than for intubated patients. If values appear extremely low, check whether the patient is breathing through the mouth or whether one nostril is blocked. Removing Exhaust Gases from the System WARNING Anesthetics: When using the Microstream CO2 measurement on patients who are receiving or have recently received anesthetics, connect the outlet to a scavenging system, or to the anesthesia machine/ventilator, to avoid exposing medical staff to anesthetics. Patient cross-infection: Do not return the sampled gas to the breathing system of the patient. Make sure that you do not accidentally connect the exhaust tube to an infusion link or any other links in the patient vicinity. Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the MMS Extension at the outlet connector. Suppressing Zero Calibration To prevent an automatic zero calibration from being started in the next five minutes, in the Setup CO menu, select No Zero for 5min, or select the Suppress CO Zero SmartKey, if configured. Selecting No Zero for 5min or selecting the Suppress CO Zero SmartKey again before the timer has timed out resets the timer to five minutes, unless an AutoZero became due during the previous suppression. Setting up all CO2 Measurements These tasks are common to all CO2 measurements except where otherwise noted. Adjusting the CO2 Wave Scale In the CO Wave menu or the Setup CO menu, select Scale. 1 2 Choose a suitable scale range from the pop-up list. 210 14 Monitoring Carbon Dioxide Setting up CO2 Corrections Temperature, water vapor in the patient's breath, barometric pressure, and the proportions of O2, N2O and Helium in the mixture all influence CO2 absorption. If values seem inaccurately high or low, check that the monitor is using the appropriate corrections. Correction Altitude
(M3014A only) O2
(M3014A only) Humidity N2O
(M3015A/B microstream only) Gas
(M3014A only) Agent
(M3014A only) Altitude is set during installation. The monitor automatically applies an appropriate correction. In the Setup CO menu, select Oxy. Corr and select a value between 20% and 100%, the default value is 20%. At installation, the monitor is configured to automatically apply either Body Temperature Pressure Saturated (BTPS) or Ambient Temperature Pressure Dry (ATPD). To see which, go to the Setup CO menu, and scroll down to look at Hum. Corr or Humidity Corr.. In the Setup CO menu, select NO Corr. and turn on or off. If N2O is present in the ventilation gas mixture, you must turn this on. If the N2O correction is not available in the Setup CO menu, the CO2 measurement in your MMS Extension does not require N2O correction or it is setup with Gas Corr. (see below). In the Setup CO menu, select Gas Corr. and select Helium, NO or turn off. If Helium or N2O is present in the ventilation gas mixture, you must make the appropriate selection. If the Gas correction is not available in the Setup CO menu, the CO2 measurement in your MMS Extension does not require N2O or Helium correction or the N2O correction is setup with NO Corr. (see above). In the Setup CO menu, select Agt. Corr and select the concentration of the anesthetic agent (between 0.0% and 20.0%). If an anesthetic agent is present in the ventilation gas mixture, you must select the appropriate concentration. Suppressing Sampling (not Mainstream CO2) To temporarily stop sampling, in the Setup CO menu, select Pump 15min Off or use the CO Pump Off SmartKey if available. Selecting Pump 15min Off again before fifteen minutes have passed resets the timer to fifteen minutes. To re-start the pump, in the Setup CO menu, select Pump On. Changing CO2 Alarms Touch the high limit on the alarm limits menu key. This refers to CO2 specific alarms. See the Alarms section for general alarm information. To change the etCO2 alarm limits, in the Setup CO menu:
1 2 Choose the high alarm limit from the pop-up list that opens. 3 Touch the low limit on the alarm limits menu key. 4 Choose the low alarm limit from the pop-up list that opens. 211 14 Monitoring Carbon Dioxide To change the imCO2 high limit:
Select imCO High and choose the high alarm limit from the pop-up list that opens. Changing the Apnea Alarm Delay This determines the time limit after which the monitor alarms if the patient stops breathing. 1 2 3 Choose the apnea alarm delay time. In the Setup CO menu, select awRR. In Setup awRR menu, select Apnea Time. WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established. Prolonged delay: The selected apnea alarm delay may be prolonged by up to 17 seconds, if an apnea occurs during the automatic zero process. This applies to the Microstream (M3015A) measurement only. Deriving Alarms From awRR In the Setup CO menu, select awRR. In the Setup awRR menu, select Alarms. 1 2 3 Choose On to derive alarms from the airway respiration signal or Off to disable them. Changing awRR Alarm Limits 1 2 3 In the Setup CO menu, select awRR. Select High Limit to set the upper alarm limit. Select Low Limit to set the lower alarm limit. Select the appropriate setting. Changing IPI Alarm Limits In the Setup CO menu, select IPI. Select Low Limit to set the low alarm limit. Select a value between 2 and 9. 1 2 3 If you also have monitors with earlier software revisions than J.0, the IPI low alarm will not be generated after a transfer to one of these monitors, or when a monitor/MMS with the IPI functionality is connected to one of these monitors in companion mode. In this case, do not rely only on the IPI low alarm but leave the individual alarms switched on (etCO2, awRR, pulse rate and SpO2) so that these alarms can be generated in such situations. 212 Understanding the IPI Numeric 14 Monitoring Carbon Dioxide The index is modeled on normal healthy patients (ASA Physical Status value of 1 according to the ASA Physical Status Classification System). Patients with ASA Physical Status values of 3 or higher are expected to have low IPI values by definition. Therefore, for patients with an ASA Physical Status value of 3 or higher, the index may have no added value. The value of the Integrated Pulmonary Index given in the IPI numeric is associated with the patient status as follows:
IPI 10 8-9 7 5-6 3-4 1-2 Patient Status Normal Within normal range Close to normal range; requires attention Requires attention and may require intervention Requires intervention Requires immediate intervention. NOTE The interpretation of the patient's IPI score may change in different clinical environments. For example, patients with specific respiratory difficulties (in contrast to normally healthy patients who are being monitored during sedation or pain management) may require a lower IPI Low Alarm threshold to reflect their impaired respiratory capacity. The IPI is available for all three groups of pediatric patients (1-3 years, 3-6 years, and 6-12 years), and for adult patients. WARNING Ensure that the patient category and date of birth are set correctly before monitoring a patient's IPI. An incorrect patient category or date of birth could produce incorrect IPI data. 213 14 Monitoring Carbon Dioxide 214 15 15Using a Telemetry Device and a Monitor The information here is for the "monitor plus telemetry" workflow with a PIIC. Refer to Managing Equipment on page 95 for information on corresponding workflows with the PIIC iX. It is possible to assign a monitor and a telemetry device to the same patient, resulting in the information from both devices being combined in one sector at the Information Center. This is called
"pairing" and when a telemetry device and a monitor are paired, the measurement data from the telemetry device will be displayed on the monitor screen. A telemetry device can be:
any Philips telemetry device (only for indirect connections, see below). a TRx/TRx+ IntelliVue Telemetry system transceiver. For complete user information, including accessory listings and specifications, for the M4841A/
M4851A TRx/TRx+ IntelliVue Telemetry Transceiver, refer to the Instructions for Use provided with the device. How Can You Combine Devices?
indirect With an connection, using standard telemetry transmission - the data are sent to the monitor via the Information Center and arrive with a delay of several seconds at the monitor. With a direct connection to the monitor, via a short range radio link - the data arrive with a minimal delay on the monitor screen. Indirect Connection - Manual Pairing The telemetry device can be paired with the monitor at the Information Center or at the monitor. For detailed information regarding pairing and configuration at the Information Center, see the Information Center Instructions for Use. To pair the monitor with a telemetry device at the monitor:
1 2 Select Main Setup then Measurements Select Telemetry The Setup Telemetry menu will appear with only one entry Paired Equipment. 3 Enter here the equipment label of the telemetry device to be paired. 215 15 Using a Telemetry Device and a Monitor Pairing at the monitor is only possible when the monitor already has a connection to the Information Center and the Information Center software version allows pairing at the monitor. Own Patient Overview Window The measurements from the telemetry device are shown in the own patient overview window on the monitor when there is no direct connection via short range radio link. See Own Patient Overview Window on page 98. Direct Connection - Automatic Pairing The following direct connections are possible:
a TRx+4841A/4851A IntelliVue Telemetry system transceiver connected via short range radio
(SRR) link to an MP2 with SRR capability. If a telemetry device is assigned to a monitor via a direct short range radio link, the monitor and the telemetry device are automatically paired at the Information Center (if configured). The measured data from the telemetry device - ECG and, if available, SpO2T - will appear on the monitor screen and will be sent through the monitor to the Information Center. The ECG waves and numerics appear in place of the monitor's own ECG, and SpO2T is displayed as an additional measurement. When ECG is measured with the telemetry device there will be no Respiration measurement derived. WARNING When ECG is being measured with a telemetry device directly connected to the monitor, there will be no ECG signal available at the ECG analog output or ECG Sync Pulse output and no synchronization marks on the ECG wave. A No ECG Out message will appear in the ECG wave channel. When a telemetry device is connected to the monitor, arrhythmia relearning is initiated, and again when the telemetry device is disconnected. Controls on the Telemetry Device (e.g. nurse call) will be inactive when the device is directly connected to the monitor except in the case when the monitor has no network connection and data are transferred via the telemetry device. See the Enhancing Telemetry Monitoring with the Monitor chapter. Assigning a Telemetry Transceiver with an SRR Adapter to a Monitor A telemetry device with a short range radio adapter can be assigned to a monitor directly. Monitors which have this capability have a short range radio symbol on the model label. NOTE If the monitor is using the MBAN frequency band (2.360 - 2.400 GHz, for US / FCC regulated countries only), direct assignment of a telemetry device is not possible. If problems occur with the direct assignment, contact your service personnel to check the frequency band used. 216 15 Using a Telemetry Device and a Monitor To assign a telemetry device to a monitor:
1 Press the Check button on the telemetry device. The measurement selection key on the monitor will change to show the "add cableless" symbol The ECG wave appears on the monitor Select the symbol. In the Add Cableless window, select the correct equipment label for the telemetry device. 2 3 4 Check that the assignment is successful and that transmission has begun:
A Tele Device assigned message appears on the monitor A tone sounds at the telemetry device and the Leads Off indicators light To confirm that the correct telemetry device has been assigned, open the ECG Setup menu. The title of the menu contains the equipment label of the telemetry device; check that this is the correct label. If a telemetry device is already assigned to a monitor, you cannot assign a further telemetry device to that monitor. If the telemetry device goes out-of-range or loses the short range radio connection, it will switch over to standard telemetry transmission to the Information Center. In this case, the telemetry data is displayed in the Own Patient Overview Window as described above. When a telemetry device with a short range radio adapter is assigned to the patient, the short range radio connection to the monitor is made automatically. If a telemetry device disappears from the list in the Add Cableless menu, press the Check button on the telemetry device again. If the monitor is not configured to be used with a telemetry device, the add cableless symbol will appear crossed out If the telemetry device is removed (unassigned), the short range radio connection will be ended. WARNING Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices and DECT phones. Outside the operating frequency band and 5% above and below, i.e. the exclusion band according IEC 60601-1-2, section 36.202.3a)4), the short range radio connection is immune up to 3V/m in the frequency range from 80 MHz to 2.0 GHz and up to 1V/m in the frequency range from 2.0 to 2.3 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a Tele Disconnected INOP. Correct channel configuration is important, refer to the Configuration Guide for details. If a Tele Disconnected INOP occurs when the telemetry device goes out-of-range, the INOP will disappear (without being silenced) as soon as the ECG signal from the telemetry device is available at the Information Center via standard telemetry transmission. 217 15 Using a Telemetry Device and a Monitor Unpairing the Monitor and Telemetry Device If the patient will no longer be monitored with the telemetry device, or only with the telemetry device and no longer with the monitor, you need to end the device pairing. After unpairing, the Information Center will receive data exclusively from the monitor or from the telemetry device:
select the Unpair To Mon. SmartKey to end pairing and have the Information Center receive the measurement data from the monitor select the Unpair To Tele SmartKey to end pairing and have the Information Center receive the measurement data from the telemetry device or use the Unpair function at the Information Center. NOTE The SmartKeys and pop-up keys for unpairing appear only on the monitor which is directly involved in pairing. Temporarily Stopping the Short Range Radio Connection To temporarily disable the SRR connection for this device, for example, in case of interference:
1 Open the Equipment window - either directly in Main Setup or by selecting the bed label in the information line. Select the telemetry device. Select Disable SRR in the menu displayed. 2 3 This closes the SRR connection and the telemetry device switches over to standard telemetry transmission. To return to SRR use:
Select Enable SRR and press the check button on the telemetry transceiver. 218 16 16Enhancing Telemetry Monitoring with the Monitor You can use a monitor without a network connection to view measurement data from a telemetry transceiver at the bedside. You can also use the monitor to make additional measurements and send this measurement data to the Information Center via the telemetry transceiver. The monitor can so be used as a mobile viewer and measurement device, and is set up to simplify the assign/unassign procedures when used with short range radio. Monitor and Telemetry Transceiver Requirements The monitor and the telemetry transceiver need a direct connection via a short range radio link. Not all revisions of the telemetry transceiver can be used directly with the monitor, if you connect a device that cannot be used you will see a Tele Unsupported INOP. Data Sent to the Information Center The data sent to the Information Center includes numerics from NBP, SpO2, Pulse from SpO2 and predictive temperature. INOPs from these measurements, battery INOPs and a general INOP generated by alarms from any other measurement (More Bed Alarms) will also be transmitted. NOTE The monitor must be configured appropriately to support direct connection to a telemetry transceiver;
refer to the Configuration Guide for details. Changing Assignment to a New Telemetry Transceiver 1 Assign the telemetry transceiver to the monitor; see Assigning a Telemetry Transceiver with an SRR Adapter to a Monitor on page 99. 2 Make the required measurements; the data will be automatically sent to the Information Center via the telemetry transceiver. It is not necessary to unassign the telemetry transceiver. This will happen automatically when the next telemetry transceiver is assigned. The patient is also discharged (if configured), ensuring that the measurement data is erased before data from the next patient appears. Always assign the telemetry transceiver before you start making measurements. 219 16 Enhancing Telemetry Monitoring with the Monitor 220 17 17Trends Trends are patient data collected over time and displayed in graphic or tabular form to give you a picture of how your patient's condition is developing. Trend information is stored in the trends database for continuously-monitored measurements, such as ECG, as well as for aperiodically-
measured parameters, such as Cardiac Output. Viewing Trends Trend information can be viewed embedded as a screen element on specially-designed Screens, or you can open a trend window over the current Screen. To view trends embedded as a screen element, enter the Change Screen window, then select a Screen designed to show an embedded trend window. To open the tabular trends window over the current Screen, select Main Setup, Trends, then Vitals Trend, or select the Vitals Trend SmartKey To open the graphic trends window over the current Screen, select the Graph Trend SmartKey
. The trend windows open displaying the most recent data and are updated as new data is stored. A timescale along the bottom or the top of the screen shows you where you are in the trends database. The preview column on the right-hand side shows the latest available measurement value. The preview column is updated every five minutes or whenever an NBP or other aperiodic measurement is completed. A question mark (?) beside a value means that the data may not be reliable, due perhaps to an INOP condition in the measurement. Your monitor screen may look slightly different to the examples shown in this chapter. Trends Pop-Up Keys When you open the graphic, tabular or histogram trends window, a selection of pop-up keys appears to let you navigate through the stored trend data and carry out trends-related tasks. 221 Pop-Up Keys Select Group Select Interval Print/ Record Print Vital Signs Graph Trend Data Source Period Select Range Column Curve On/Off Adjust Cursor Selecting this pop-up key lets you.... see a pop-up list of trend groups and select a group for viewing. see a pop-up list of available data resolution settings and select the level of detail shown in the trend view. print a tabular trends report or make a tabular trend recording of the data in the current window. The report will use the current trend interval settings. print a graphic trends report or histogram report of the data in the current window. The report will use the current trend interval settings. move the cursor one step to the left or right to navigate through the trends database timeline. move the cursor one page to the left or right to navigate through the trends database timeline. jump to the beginning or the end of the trends database to see the most recent or oldest trend information stored. scroll up and down the screen to see measurement trends that do not fit in the current view. open the current trend view in tabular form. The displayed time period and resolution stay the same. open the current trend view in graphic form. The displayed time period and resolution stay the same. select a realtime SpO2 or realtime system pulse or trended data for display in the histogram. select a time period for the histogram. define the range of values to be displayed in the histogram by selecting an upper and a lower limit. select a column width for the histogram. For each width selection the resulting number of columns is shown. switch the display of the cumulative value columns in the histogram on or off. open a new set of pop-up keys for switching on cursors and setting their positions. 17 Trends 222 Viewing Graphic Trends 17 Trends Scroll to view more pop-up keys 1 A cursor spanning all measurements in the trend group helps you to navigate through the trends database and shows you your current position in the database. When the cursor is moved across the time line, the values measured at the cursor time are shown in the right hand column. In graphical trends, aperiodic measurement trends are shown as an asterisk, NBP has a special symbol. To use the trend cursor to navigate in time through the trends database, 1 2 Use the arrow pop-up keys to move the trend cursor backwards and forwards in time, or 3 Select the graphical trend or the arrow pop-up keys to activate the cursor. Place the cursor at a specific time by touching the graph. Viewing Vital Signs Trends 223 17 Trends Scroll to view more pop-up keys 1 Aperiodic values are shown with a timestamp 2 The currently-selected column is highlighted. The values can be configured to display in the same colors as the waves and numerics on the realtime display. Any values available for display before the next scheduled update are shown in the right hand column, with a timestamp in brackets. If more than one value is available for an aperiodic trend for a certain trend period, all measured values are stored in the database and the value closest to the timestamp is shown in the Vital Signs display marked with an arrow. To view the Vital Signs trend with one column for each NBP measurement (see Defining the Column Interval Using the NBP Measurement on page 227):
1 With the Vital Signs trend open, select Interval. 2 Select NBP from the pop-up list. Setting Up Trends Trends are set up in Configuration Mode. You can make temporary changes to trends settings such as trend groups, priorities, or scales in Monitoring Mode. The general settings for all Trends are under Main Setup, Trends. Settings for a single segment in graphical trends or for the corresponding trend group can be made more easily in that segment menu. Making Segment Settings The Graphical Trends window is divided into measurement segments, each of which has its own settings. To enter the segment menu, select the left hand column of the segment, where the measurement label is displayed. Expanded View in the Segment menu, select Expand to have that segment enlarged to fill the window. To expand the segment to fill the Graphical Trends window, In the expanded view, you can also highlight a measurement to make it more easily visible (for example when multiple ST trends are in one segment). To highlight a measurement, in the Segment menu, select Highlight repeatedly until the highlight is on the required measurement. To return the segment to its original size, in the Segment menu, select Expand again. Trend Scales for Segment Measurements To change the trend scales for a measurement in the current segment:
1 2 In the Segment menu, select the measurement label. Select Upper to change the upper limit of the scale or Lower to change the lower limit of the scale. 224 Optimum Scale 17 Trends in the Segment menu, select Optimum Scale. To have the monitor automatically select an optimum scale for viewing, based on current values, This scale change is temporary. When the graphical trend window is closed the scale reverts back to the setting in Parameter Scales. To switch off automatic optimum scaling, in the Segment menu, select Optimum Scale again. Trend Group To add or remove measurements for this trend group or change the order of the existing measurements:
1 2 Use the Add, Change, Sort Up and Sort Down pop-up keys to change or re-order the group as In the Segment menu, select Change Group. required. Number of Segments In an embedded graphical trend window, you can select the number of segments to be displayed in the Segment menu:
In the Segment menu, select No. of Segments. Trend Groups The measurements grouped in trend groups define the trends displayed together in the Vital Signs or Graphical Trends windows and printed in trends reports and recordings. The sequence of the measurements in the group defines the order in which they are displayed. Measurements listed between dotted line separators are displayed overlapping. The trend group All contains all available measurements, you cannot change the order or selection of this group. To change the selection of measurements in a trend group, either use the Change Group setting in the Segment menu or:
1 2 Select Main Setup, Trends, then Trend Groups. Select the Trend Group you want to change and use the pop-up keys to Add, Change, or Delete the selection of measurements trended. To temporarily change the order in which the measurements are displayed in a group, 1 2 Select Main Setup, Trends, then Trend Groups. Select the Trend Group and then the measurement you want to move and use the Sort Up/Sort Down pop-up keys. Trend Interval The trend interval defines the resolution of trend data shown on the Screen. To set the trend resolution, in the Vital Signs or Graphical Trends window, Select the Select Interval pop-up key and then select the required interval from the list. 225 17 Trends Trend Priority The monitor stores trend information for all monitored measurements, if configured to do so. If your configuration restricts the number of measurements trended, you must choose which measurements will be included. A priority list is used to select the trended measurements. To see the measurement priority list for trending, 1 2 To add measurements to the priority list, 1 2 Use the Sort Up and Sort Down pop-up keys to change the priority order. Select the pop-up key Add and choose from the pop-up list of available measurements. In the Main Setup menu, select Trends. Select Trend Priority. Trend Parameter Scales Parameter scales define how the trend waveform will appear on the screen and in trend reports. Separate scales can be set for adult, pediatric, and neonatal patient trends. To change the trend parameter scales settings, either use the Scale setting in the Segment menu or:
1 2 3 4 5 In the Main Setup menu, select Trends. Select Parameter Scales. Select the measurement or parameter you want to change from the list. Select the pop-up key Change to call up the Scale menu. In the Scale menu, select the parameter label you want to define settings for. Select Adult, Pedi, and Neo and use the pop-up keypad to enter new upper and lower scale definitions. Graphical Trend Presentation Graphical trends and screen trends for measurements with compound values (for example ABP or CO2) can be viewed in line or band form. To change the presentation style, 1 2 Select Main Setup then select Trends. Select Global Style and choose Line to display the trends as a continuous line Band to fill the area between the trend lines, for example, between the systolic and diastolic pressures, with color. This sample ABP trend shows the continuously-measured values for the systolic, diastolic and mean pressures displayed in band form. 226 17 Trends Defining the Column Interval Using the NBP Measurement You can have the NBP measurement determine the interval between the columns on the Vital Signs trend. Each NBP measurement will generate a column in the trend table. The values for the other measurements are added to the column to provide a complete vital signs set for the NBP measurement time. To use the NBP measurement to determine the column interval:
1 2 3 Select Main Setup then Trends. In the Trends menu, select Setup VitalSigns. In the Vital Signs menu, select Column and then NBP from the pop-up menu. Documenting Trends To print a Vital Signs or Graphical Trends report, in the Vital Signs or Graphical Trends window, select the pop-up key Print to print a report for the trend group currently on the monitor screen. Reports include the most recent information in the trends database and extend backwards in time according to the selected trend interval and your monitor's configuration. Trends reports can be printed on central or local printers. Trends Databases The trend databases store information for up to 16 measurements for up to 48 hours. The values in the trends database are stored as measured by the monitor, they are not averaged values. The trend resolution defines how often a value is stored. In general, if more than one value is available for storage in the trends database, the most recent value is used. Some values in the trends are marked with arrows. This indicates that for this time period, more values were available and the most recent one is shown. Example database configuration In this example, we see that the monitor stores the most recent data at the highest resolution, older data are stored at a lower resolution.
"4 hours @ 12 second resolution" means that the monitor stores trend data every 12 seconds, for the most recent four hours. 227 17 Trends Aperiodic Trends Database Aperiodic trends do not count toward the maximum number of trends allowed by the trend configuration. Trend data for aperiodic measurements is stored in a separate database and timestamped with the measurement time. Trending Multiple-Value Measurements Some measurements generate multiple values, for example invasive pressure measurements can provide systolic, diastolic, and mean values. These values are trended as separate measurements. Screen Trends Trends configured to display permanently on special monitor Screens are called Screen Trends. The selection and number of measurement waves in the Screen Trend segment depends on your monitor configuration. Screen Trends are color-coded to match the measurement wave and numerics, and they can be viewed in graphical, tabular, histogram or horizon format. If you do not see Screen Trends on the monitor Screen, select a different Screen, one that is configured to show Screen Trends. Screen Trends are only available on specially designed Screens. Screen Trend information is taken from the Trends database. If you do not see a Screen Trend for a particular measurement on the Screen, check the trend priority list to ensure that this measurement is being trended. Setting the Screen Trend Time To set the ScreenTrend Time for all graphical, histogram and horizon screen trends ("global" trend time), 1 2 Select a screen trend then select Setup Trend, or select Main Setup then select Trends. Select ScreenTrend Time and select the required time: 30 minutes, one, two, four, eight, or twelve hours. This is now the Global screen trend time and defines the period of trend information shown for all screen trends. To set a different ScreenTrend Time for a screen trend or a group of aligned screen trends, 1 2 3 Select a screen trend. Select Change TrendTime. Select the required trend time. Selecting Global leaves the trend time set to the global screen trend time. Changing the Selection of Screen Trends Displayed 1 2 Select the screen trend. Select Change Trend and select the required trend from the list of available trends. Select Blank to remove the selected trend from the Screen. If you do not see Change Trend in the screen trend menu, the trend is aligned to display with the measurement wave. Changing the wave automatically changes the trend. 228 17 Trends To display two or more screen trends overlapping, 1 2 Select the screen trend to open the screen trend menu, Select Change Trend followed by Add Trend and select a screen trend from the pop-up list. Activating the Cursor for Screen Trends Select the screen trend. Select Activate Cursor. To activate the cursor for Screen Trends:
1 2 You can now use the arrow keys to move the cursor across the time line. The values measured at the cursor time are shown next to the cursor. To de-activate the cursor, Press the Main Screen key. Changing the Screen Trend View To switch between tabular, graphic, histogram and horizon views, select the screen trend then select Change View and select the required view. Tabular View Aperiodic measurements such as NBP, can be viewed as a screen trend in tabular form. The measured values and their timestamps are shown, with the measurement label. Horizon View The horizon view presents trend information superimposed over a defined baseline or base range. This helps you visualize changes in your patient's condition since the baseline was set. The horizon view is made up of:
a horizon, drawn in white, as a reference point or baseline to help you visualize changes in your patient's condition. The horizon can be set to represent your patient's current condition, or a target condition and can be a single value or a range. a graphical trend, displaying patient data for the set TrendTime (1). a trend indicator arrow, indicating how the patient trend has developed in the set time period
(10 minutes, 5 minutes or 2 minutes) (2). 229 17 Trends a deviation bar, showing how the currently measured value deviates from the set horizon (3). The height of the deviation bar is an indication of the extent of the change in your patient's condition relative to the (horizon) baseline. Your monitor may not be configured to show all elements of the screen trend horizon view. Setting the Horizon The horizon is the reference value to which deviations in the measurements are compared. To set the horizon:
1 2 Select the horizon trend. Select Set High Horizon to select the upper horizon value. If the high and low horizon values are the same, the horizon is a baseline - if the values are different the horizon is a range. Set Low Horizon to select the lower horizon value. Auto Horizon to set the horizon for the selected horizon trend to the currently-measured value. Auto All to reset the horizon for all horizon screen trends to the currently-measured values. Set Horizon to set the horizon to a specific value from a pop-up list. Setting the Horizon Trend Scale The horizon trend scale is defined with respect to the horizon. If your horizon is set to 100 and you select 20 as the horizon scale delta, the upper limit of the horizon scale will be 120 and lower limit 80. To set the horizon trend scale delta, 1 2 Select the horizon trend. Select Set Scale Delta and select a value to define the distance between the horizon and the upper and lower scale limits. Be aware that changing the horizon trend scale can change the angle of the trend indicator, without the patient's condition having changed. If a measurement exceeds the outer limits of the scale, the wave will be clipped and you must either reset the horizon or the horizon trend scale to display the values outside the scale limits. Setting the Time Period for the Trend Indicator Arrow The time period for which the trend indicator arrow is displayed can be set in the Trends window. 1 2 3 Select Main Setup then select Trends. Select HorizonArrowTime. Select 10, 5 or 2 minutes. 230 18 18Recording Central Recording For central recording from the bedside, your monitor must be connected via a network to an Information Center. You can use either the M1116B/C or 862120 2-Channel Recorder or the standalone M3160A 4-Channel Recorder. Recordings made on the M3160A may look slightly different to those described here. See the documentation supplied with the Information Center for information on the 4-Channel Recorder. Starting and Stopping Recordings The recordings pop-up keys let you start and stop recordings. Select the Main Setup SmartKey then select Recordings to call up the line of pop-up keys. Scroll right or left to see any pop-up keys not displayed. Delayed Recordng RT A Recordng RT B Recordng Select Waves Setup Recordng Stop All Recordng Recording Without a Template To record without a preconfigured template, selecting the waves you require, 1 2 3 Use the pop-up keys to choose up to three measurement waves to be printed on the recording. If Select the Main Setup SmartKey, then select Recordings. Select the pop-up key Select Waves. you want fewer than three waves on the recording, select the waves you want then select the Continue pop-up key. Select one of the recording speed pop-up keys to set the required recording speed. Select the Start pop-up key to start the recording. 4 5 Select Waves recordings use default values for any recorder settings not defined: runtime is continuous, overlapping is set to non-overlapping. 231 18 Recording Overview of Recording Types Delayed Type of recording manual Recording Destination central Alarm automatic, triggered by defined alarm conditions central printer Realtime (RT) manual central from the start trigger minus the delay time Information recorded Number of waves up to 2 Speed 50, 25, 6.25 mm/sec n/a automatically 10, 15 seconds Runtime Stops Delay Time Overlap from the start trigger minus the delay time up to 2 25 mm/sec n/a automatically 10, 15 seconds Off On (up to 2 waves) Off On (up to 2 waves) n/a n/a n/a n/a n/a n/a n/a from the start trigger up to 2 50, 25, 6.25 mm/sec continuously manually none Off On (up to 2 waves) n/a = not applicable Creating and Changing Recordings Templates To save you defining recording settings each time you start a recording, you can create templates for commonly-used types of recordings in the Setup Recordings menu. You can create templates for one delayed recording, one alarm recording and two realtime recordings (Realtime A and Realtime B). Changing recordings templates changes the settings that will be used each time a recording of this name is triggered. 1 2 3 4 Select the Main Setup SmartKey to call up the Main Setup menu. Select Recordings. Select the Setup Recordng pop-up key to enter the Setup Recordings menu. Select the name of the template you want to create or change. Each recording name is linked to a recording type: delayed, alarm, and realtime. Recording names can be changed in the monitor's Configuration Mode. 5 Design the template by selecting each menu item and entering the information for the template. Recorder: choose which recorder the recording will print to (Central 2-Ch or Central 4-Ch recorder, or a printer (for realtime reports in alarm recording only)). Channel 1, Channel 2, etc.: choose which waveform to record in each channel. In addition to the currently available waves, you can choose from several other settings which make an automatic allocation when the recording starts:
Overlap: define whether the recorded waveforms will be printed overlapping or beside each other. Alarm Par will always record the measurement in alarm in the chosen recorder channel Primary Lead will always record the current primary lead in the chosen recorder channel SecondryLead will always record the current secondary lead in the chosen recorder channel 232 18 Recording Speed: choose the recording print speed. Delay Time: Delayed recordings start documenting on the recorder strip from a pre-set time before the recording is started. This interval is called the "Delay Time" and can be set as specified in Overview of Recording Types on page 232. This setting can only be changed in Configuration Mode. Run Time: see how long this type of recording is configured to run. This setting can only be changed in Configuration Mode. Continuous recordings run indefinitely. Central Config - if available in the General menu, select this setting to use the recording settings made for the centrally-connected recorder. Maintaining Recording Strips Recording ink sometimes fades when covered with transparent tape. Avoid covering any part of a recording that is clinically relevant (annotation or waveforms) when taping a recording strip to a patient record or other patient documentation. Recorder Status Messages CAUTION If no central recorder is available, alarm recordings may be lost. The message No alarm recording available will be displayed. This message is not shown if Printer is configured as the alarm recording destination. Recorder Status Messages
<Recording Name> running No alarm recording available Central Recorder out of paper Central Recorder door open Explanation The named recording is currently running. No recorder available. Alarm recordings will be lost. Try configuring Printer as the alarm recording destination. The named recorder is out of paper. The door of the specified recorder is open. 233 18 Recording 234 19 19Printing Patient Reports Starting Report Printouts Most patient reports can be printed by selecting Main Setup then Reports (or the Print Reports SmartKey) and then selecting the report name in the top half of the Reports menu. Report names are shown only for reports that have been correctly set up. Data from the time of the print request is printed, even if the print job is delayed in the printer queue. Your monitor can also be set up to automatically print all reports when a matching printer is available. To set this up 1 2 Select Main Setup, then select Reports. Select Auto Print Dbs. Never will print no reports automatically; all reports stored in the database must be manually Always will print all reports when a matching printer is available. sent to the printer. See Checking Report Status and Printing Manually on page 240. Printout Location on printers connected to the Information Center, to an IntelliVue XDS Application print service, to an external PC-based print server with Philips server software, into the print database. Depending on availability, reports can be printed:
Print jobs stored in the database are automatically printed when a print device with a matching paper size becomes available. Print jobs in the print database are not deleted after a patient discharge. A new patient can be admitted and their reports are saved in addition to the previous reports. Always admit your patient so that reports can be clearly assigned to a patient. 235 19 Printing Patient Reports Starting the Different Types of Report Report types Vital Signs Report Graphic Trends Report ECG Reports 12-Lead Report ST Map Report Alarm Limits Report Realtime Reports Battery Report Central Report A/B/C Report contents Depends on selected trend group, data resolution, and period. Depends on format selected. Captured ECG waves, measurement values, ST Map
(optional) and analysis results from the Information Center (PIIC iX only) ST data in a transversal and/or horizontal multi-axis diagram Graphic and numeric report of all current alarm limits Patient data and numerics, and either:
all displayed waves OR all measured waves OR all measured RT waves Battery serial number, information on the currently-
measured and potential charge status of the battery These are reports configured at the Information Center. Monitors connected via the IntelliVue Instrument Telemetry wireless network can have these reports available. How to start printing reports In the Vital Signs window, select Print/ Record, then select Print. In the Graphical Trends window, select Print. Select the ECG Report A, or ECG Report B SmartKeys, if configured, or the Print Reports SmartKey followed by ECG Report A or ECG Report B. In an active 12-Lead application window, select the Print Report pop-up key. In the ST Map (Current) or ST Map (Trend) window, select Print. In the Alarm Limits window, select Print Limits. Select the Realtime Report SmartKey, if configured. In the Battery Status window, select Print Status. In the Main Setup select Reports then Central Report A, Central Report B or Central Report C. Stopping Reports Printouts To stop Reports printing, in the Reports menu, select Delete Report to stop the current print job Delete All Repts to cancel all queued report printouts Scheduled Rep. to select Off and switch off scheduled reports. Setting Up Reports The content you define in the individual Setup Reports menus will be used in all reports of this type: for example, if you set a print speed of 50 mm/sec in the ECG Reports menu, every ECG report will be printed at this speed, irrespective of format. ECG report layout and Auto Reports settings must be defined in Configuration Mode. Setting Up ECG Reports The settings you choose in the ECG Reports menu apply for all ECG-A and ECG-B reports printed. To set up ECG Reports, 1 Select Main Setup, Reports, then ECG Reports. Note the report layout configured for your monitor, either Internat or Cabrera. This setting is inactive ("grayed-out") in Monitoring Mode and can only be changed in Configuration Mode. 236 19 Printing Patient Reports 2 3 4 Select ECG Gain and set the required ECG gain to define how ECG waves will appear on the ECG report printouts. Select Speed and select the report print speed. Select Annotation and switch to On if the printed ECG wave should be annotated with beat labels. See the ECG, Arrhythmia, ST and QT Monitoring chapter for a list of beat labels. Pace pulse marks are automatically printed beside the wave for paced patients. Setting Up Vital Signs and Graphic Trend Reports The settings you choose in the Vital Signs Report and Graphical Trend Report menus apply for all Vital Signs and Graphic Trend reports printed. To set up Vital Signs and Graphic Trend reports, Select Main Setup, Reports, then Vital Signs Rep. or Graph Trend Rep.. 1 Select Trend Group and select the group you want to print on the report. The groups available depend on your monitor's trend configuration. Select Period and select the period of time for which trend data should be printed on the report. If Automatic Period is configured to On, all trend data for the current patient will be printed, irrespective which trend period is selected. Select Interval (Vital Signs Reports only) and select the resolution of the trend data printed on the report. 2 3 Setting Up Auto Reports Auto Reports print automatically when a specified trigger occurs. There are two types of Auto Reports:
Scheduled Reports, which print at predefined intervals, and End Case Reports, which print when a patient is discharged using the End Case function. An Auto Report can be both a Scheduled Report and an End Case report. To set up Auto Reports, 1 Select Main Setup, Reports, then Auto Reports and select the Auto Report you want to set up (A, B, C, or D). Select Report and assign a report type to the Auto Report. Select End Case Report and switch to On if you want the selected report to print automatically when you select End Case to discharge a patient. Switch End Case Report to Off if the report is a Scheduled Report only. Select Scheduled Rep. and toggle to On if you want the selected report to print at predefined intervals, starting at a predefined time of day. The start time you set applies for every following day. For example, if you set a start time of 07:00 and a repeat time of six hours, the first report will print at 07:00 every day, the next at 13:00 and so on. To set the time of day at which you want the report to print every day: select Start Hour and 2 3 4 Start Minute and select the required time from the pop-up list To set the time interval in minutes between two scheduled reports: select Rep. Freq. (h) and Rep. Freq. (min) and select the time interval from the pop-up list. If you are setting up an end case report, these settings will be inactive ("grayed-out"). Switch Scheduled Rep. to Off if the report is an End Case Report only. 5 Repeat the procedure for all Auto Reports you want to set up. All Auto Reports or Scheduled Reports set to On print automatically at the predefined trigger. 237 19 Printing Patient Reports Be aware that the monitor's memory for reports is limited. The number of reports that can be stored depends on the size of the reports and the size of the printing database; the maximum is 30 reports. If the memory is full, reports cannot be saved on the printing database and therefore cannot be printed. If you set up regular scheduled reports, and you have long case durations, make sure that the print database is configured to Large and plan to print reports at appropriate intervals in order to avoid losing information due to a full memory. Setting Up Individual Print Jobs To adjust the appearance of individual print jobs, in the Reports menu, Select Main Setup, Reports, then Setup Reports to enter the Setup Reports menu. 1 2 Select Report and then select the report you want to set up. Select Report Type and then select the reports template you want the report selected in Step 2 to use. The selection of templates listed depends on the report type selected. Each template includes patient demographic data, and each Realtime Report also includes alarm and INOP information. In addition, the templates include:
VisibleWaves: all waves currently visible, in the order they appear on the screen. All Waves: all measured waves. RT Waves: all currently measured realtime waves, according to the monitor's priority list. Vital Signs: trend information in tabular form. Graph Trend: trend information in graphic form. ECG3x4, ECG6x2, ECG12x1, ECG4x2, ECG8x1, ECG12x1 (2P): ECG reports. Alarm Limits: a list of all currently set alarm limits. Select Report Size to set the paper size to be used for the report: Unspecified to use the default size for the template chosen, Universal, A4, Letter, LrgUniversal, A3, or Ledger. The list of available sizes depends on the report type selected. Select Orientation to set the orientation of the report printout: Unspecified to use the default size for the template chosen, Landscape or Portrait. Select Target Device and choose which printer the print job will be sent to: Unspecified to use the default printer, or choose from the list of printer names defined at the Information Center or in the monitor's Configuration Mode (for example, Remote 1 or Database). 3 4 5 Some settings may be inactive ("grayed-out") in this menu for reports that can only be started in a special window. Checking Printer Settings The printer settings for your monitor are defined in Configuration Mode. The printer settings Paper Size, Resolution, Color Support, and Duplex Option for the active printer are visible but inactive ("grayed-
out") in the Setup Printers menu. When Print Database is selected as active printer only the Paper Size setting will be shown. If you are using an IntelliVue XDS Application print service, you may see XDS printers in the Setup Printers menu that have "Local" or "Remote" in their name. Their names and settings can only be configured in the XDS Application. Refer to the IntelliVue XDS Application Installation and Configuration Guide for full details about the configuration possibilities. To enter the Setup Printers menu, in the Reports menu, select Setup Printers. 238 19 Printing Patient Reports Printing a Test Report A test report can be printed in Configuration mode, refer to the Service Guide for details. Switching Printers On or Off for Reports 2 You can enable or disable printer status to switch individual printers on or off for report printouts. 1 In the Setup Printers menu, select Printer and then select the name of the device you want to switch on or off for Reports printing from the pop-up list. Select Printer Status to switch between the settings Enabled and Disabled. If you set this to Disabled, no reports will be printed to the named printer. If the monitor detects that no printer of a particular type is available, the Printer Status setting will automatically be set to Disabled and "grayed out". Local printers from the XDS Application print service are always enabled and cannot be disabled here. Dashed Lines on Reports If a section of a wave on a report is drawn with dashed lines, this tells you that a setting that affects the appearance of the wave on the screen was changed while the report was printing. For example, if you change the wave scale while a report is printing, the wave scale and wave size are changed immediately on the monitor screen and on the report. To indicate that the scale information printed at the beginning of the report no longer matches the currently used scale, the wave will be printed using dashed lines, starting from the moment the change took place. Some examples of settings that cause dashed lines in reports if changed during printing are: Filter mode, ECG lead placement, wave scale, measurement unit, paced/non-paced setting, and measurement mode. Note that as ECG waves are drawn with a fixed gain on reports (either 10 mm/
mV or 20 mm/mV), changing the ECG wave scale will not cause dashed-line reports. To avoid dashed lines on reports, wait 15 seconds after changing a setting before you trigger a report. Unavailable Printer: Re-routing Reports If you send a report to be printed on a printer that is not available, for example, because it has run out of paper, this print job is suspended and stored in the monitor's memory. If the target device of this print job was set to Unspecified, the monitor will periodically try to resend the print job to the first printer listed in the Setup Printers menu under Printer that is set to Enabled and that has paper of the correct size. 239 19 Printing Patient Reports To allow the report to print, you must either solve the problem with the target printer, or re-route the print job to another printer with paper of the correct size. To re-route a print job, Enable the new target printer by selecting it in the Setup Printers menu and toggling to Enabled. As the monitor tries to send the report to the printers in the order they are listed, you must make sure that all the printers above the new target printer are disabled. If the target device of the print job was set to a specific printer, re-routing is not possible. Checking Report Status and Printing Manually A list of all print requests which are waiting, printing or stored can be viewed in the Report List. To view the list, in the Reports menu, select Report List. The following information is displayed for each print request:
Individual reports can be deleted from the list with the Delete Report key, and all reports with the Delete All Repts key. Report title Patient name (except for system reports such as the battery status report) Request date and time Report paper format Job status: Preparing, Printing, Waiting, In Database, Retry, Cancelling, Error. CAUTION The Report List includes privacy information, in the form of the patient name with the related report title and date. It is advisable to provide controlled access to this data to ensure confidentiality. Printing Manually Those jobs shown in black will be printed automatically when a matching printer is available. If the Auto Print Dbs setting is Host Only or Never, some or all reports will not be printed automatically and will be shown in gray. Any jobs shown in gray must be printed manually; to do this, 1 2 Selecting Print All Reps will send all reports to the printer. In the Report List, select the required report Select Print Report. 240 Printer Status Messages 19 Printing Patient Reports Printer Status Message Print job queued for <Printer Name>
Print job can't queue;resources?
Print job can't queue;queue full Print job can't queue;no printer Cancelling all print jobs Cancelling the active print job Deleted # print jobs;discharge Deleted # print jobs; hotstart Print failed;No report configurd Printing on <Printer Name>... NoPrinter <Printer Name>;job susp. Print database full->job suspnd. Job <Printer Name> failed; no data Job <Printer Name> fail;no printer Job <Printer Name> fail;data error Possible causes and suggested action The report has been placed in the queue for the named printer. The printer queue is full and the monitor cannot accept another report request. Wait until some more reports have been printed, then try again, OR A report has been triggered that uses a paper size unavailable with the target printer. Try another printer, if available, or change the paper size of the print request. Delete All Reps has been selected in the Reports menu, OR The Operating Mode has been changed from Monitoring Mode to Demonstration or Service Mode. The current report is being canceled as the result of a user request. When a patient is discharged, all queued reports are canceled except those stored in the print database. "#" is the number of reports canceled. The monitor has restarted and all report requests have been canceled except those stored in the print database. "#" is the number of reports canceled. A report has been triggered which has not been correctly set up. Enter the setup menu for the report type to set up the report. A report is in progress, or the monitor is waiting for the central printer to accept the print job. The chosen device is unavailable. Check that the printer is properly connected and that paper is available. The requested report will start printing when the printer becomes available. The requested report does not fit into the print database. You can select another printer to print the report (see Unavailable Printer: Re-routing Reports on page 239). Alternatively you can delete another report from the Report List (using the Delete Report key) to create space for your report. A report cannot be started on the requested printer. One of three reasons is shown in the status message:
data unavailable - the connected X2 has been removed before the data for the report was transferred. printer unavailable - make sure the printer is plugged in, switched on, and has paper loaded. data requisition error - an internal error has caused data required for the report to be unavailable, try starting the report again. Print job on <Printer Name> done The report has been printed. 241 19 Printing Patient Reports Sample Report Printouts Each report header contains the patient's bed label, last name and first name, middle name (if there is enough space) the patient ID, the date and time, and the name of the report. The report footer contains the hospital label and page number, and the last page contains a note to mark the report end. The monitor may be configured to leave a space on the top left or right of the report printout to enable you to stick a patient address label on it. This setting is called the Addressograph and it can only be changed in the monitor's Configuration Mode. Alarm Limits Report 1 Measurement labels, with alarms off symbol where alarms are switched off 2 Graphic view of current alarm limits in relation to currently monitored measurement value Realtime Report Patient demographic information, time stamp 1 2 Active Alarms and INOPs, followed by vital signs 3 Measurement waves section 242 ECG Reports 19 Printing Patient Reports Patient information 1 2 Numeric block 3 Wave area Below the header on ECG Reports, the numeric block shows the current HR, PVC, and ST values. The wave area shows the printed waves for all available ECG leads. A 1 mV calibration bar is printed at the beginning of each wave. With the 3X4, 6X2, and 2X4 formats, a rhythm stripe prints a longer section of the ECG wave from the primary ECG lead for ECG rhythm evaluation. The ECG signal bandwidth, the patient's paced status, the ECG gain, and the print speed are printed at the bottom of the wave area. Pace pulse marks are automatically printed beside the wave for paced patients. Beat labels can be set to print on the rhythm stripe. The 12X1 (2P) format prints the report over two pages. ECG Report type 12-Lead ECG Multi-lead ECG Available Formats 3X4 landscape 6X2 landscape 12X1 portrait 12X1 landscape 12X1 (2P) landscape 2X4 landscape 8X1 portrait 8X1 landscape Available Paper Sizes A4, letter, A3, ledger A4, letter, A3, ledger A4 and letter only A4, letter, A3, ledger A4, letter (2 pages) A4, letter, A3, ledger A4 and letter only A4, letter, A3, ledger 243 19 Printing Patient Reports 12-Lead ECG Report Patient data 12-Lead wave area 1 2 Analysis data from the Information Center (PIIC iX only) 3 4 Data related to the wave presentation 5 6 Administrative data - including optional custom text fields 7 Hospital ID data - Institution, facility and department, if configured ST Map with related ST numerics (optional) Other Reports See the sections on Trends for other example reports. 244 20 20Care and Cleaning Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospital's Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health Care and Public-
Safety Workers" issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, February 1989. See also any local policies that apply within your hospital, and country. General Points Keep your monitor, cables and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, decontaminate it first. Observe the following general precautions:
Always dilute cleaning agents according to the manufacturer's instructions or use lowest possible concentration. Do not allow liquid to enter the case. Do not immerse any part of the equipment or any accessories in liquid. Do not pour liquid onto the system. Never use abrasive material (such as steel wool or silver polish). Never use bleach except in an approved product listed in this chapter. WARNING If you spill liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. 245 20 Care and Cleaning Cleaning the Monitor Clean with a lint-free cloth, moistened with warm water (40C/104F maximum) and soap, a diluted non-caustic detergent, tenside, ammonia- or alcohol-based cleaning agent. Do not use strong solvents such as acetone or trichloroethylene. Take extra care when cleaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around, not over, connector sockets. CAUTION To clean the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by pressing and holding the Main Screen key for two seconds. Press the Main Screen key again to re-enable touch operation. Recommended cleaning agents are:
Tensides (dishwasher detergents) Ammonias Alcohol Edisonite Schnellreiniger, Alconox Dilution of Ammonia <3%, Window cleaner Ethanol 70%, Isopropanol 70%, Window cleaner Disinfecting the Equipment CAUTION Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result. Clean equipment before disinfecting. Recommended types of disinfecting agents are:
Product Name Isopropanol Bacillol AF Bacillol 25 Meliseptol Accel TB RTU Oxivir Tb Cleaner Disinfectant Oxivir Tb Wipes 246 Product Type liquid liquid, spray liquid spray liquid spray wipes Ingredients Isopropanol 80%
100 g concentrate contains:
Propan-1-ol 45.0 g;
Propan-2-ol 25.0 g;
Ethanol 4.7 g Ethanol 100 mg/g Propan-2-ol (= 2-Propanol) 90 mg/g;
Propan-1-ol (= 1-Propanol) 60 mg/g 50% 1-Propanol 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide 0.5% accelerated hydrogen peroxide 20 Care and Cleaning Product Name Carpe DiemTM/MC Tb Ready-to-Use General Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizer Carpe DiemTM/MC Tb Wipes Super Sani-Cloth Germicidal Disposable Wipes SANI-CLOTH PLUS Germicidal Disposable Wipes SANI-CLOTH HB Germicidal Germicidal Disposable Wipes Clorox Hydrogen Peroxide Disinfecting Wipes 1 Product Type spray Ingredients 0.5% accelerated hydrogen peroxide wipes wipes wipes wipes wipes 0.5% accelerated hydrogen peroxide isopropanol 55%
quaternary ammonium chlorides 0.5%
isopropanol 15%
quaternary ammonium chlorides 0.25%
isopropanol < 0.15%
quaternary ammonium chlorides 0.14%
1 - 5% hydrogen peroxide 1 - 5% benzyl alcohol 1 Do not use Clorox Hydrogen Peroxide Disinfecting Wipes for snap fits (for example the battery cover) or hinges. Remove all residues with water after the residence time. For repeated or prolonged use, wear rubber or nitrile gloves to protect your hands. Sterilizing the Equipment Sterilization is not allowed for this monitor, related products, accessories or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies. Cleaning, Sterilizing and Disinfecting Monitoring Accessories To clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the instructions delivered with the accessory. If no instructions are delivered with the accessory, the instructions given in this chapter for cleaning, disinfecting and sterilizing the monitor are applicable. Cleaning Batteries and the Battery Compartment Wipe with a lint-free cloth, moistened with warm water (40C/104F maximum) and soap. Do not use strong solvents. Do not soak the battery. 247 20 Care and Cleaning 248 21 21Using Batteries The Lithium Ion batteries used in your monitor store a large amount of energy in a small package. This allows reliable battery-operated monitoring but also requires care in use and handling of the batteries. Follow the instructions in this chapter and refer for further details to the Service Guide. When monitoring a patient, one Philips M4607A rechargeable Lithium Ion battery must always be inserted into the battery compartment on the right side of the monitor. This applies even when you are running the monitor from the external power supply. The battery seals the battery compartment, preventing the ingress of fluids or foreign bodies. A severe yellow INOP (!! Insert Battery) will be issued if the monitor is connected to AC mains without a battery fully inserted in the battery compartment. This INOP will persist until a battery is inserted. 1 Battery compartment To use the monitor with battery power, disconnect the external power supply, by removing the MSL cable from the monitor. You can switch between battery-powered and mains-powered (AC) operation without interrupting monitoring. The battery recharges automatically when the monitor is connected to the external power supply
(M8023A). 249 21 Using Batteries Battery Power Indicators The battery LED and battery status information on the Main Screen, in combination with INOP messages and prompts, help you keep track of the battery power status. The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery Status window. Battery LED The battery LED on the front panel of the monitor is indicated by a battery symbol. 1 Battery LED The battery LED is off during regular monitoring, when none of the following situations is present:
Battery LED Colors If the monitor is connected to the external power supply
(M8023A), this means If the monitor is running on battery power, this means Yellow Red, flashing Red, flashes intermittently battery charging less than 10 minutes power remaining battery or charger malfunction battery malfunction Battery Status on the Main Screen The battery status information includes the battery power remaining and, when the battery is not charging, an estimate of the monitoring time this represents. Battery power gauge:
This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three sections are filled, as in this example, this indicates that 60% battery power remains. If no battery is detected, a blank battery gauge marked with a flashing red X is displayed. If no data is available from the battery, a question mark is shown in the gauge. If the monitor is powered from the Battery Extension, the battery gauge shows the remaining power for the battery in the Battery Extension. 250 21 Using Batteries If there are problems or changes in the status of the battery this is indicated by a blank battery gauge containing a symbol. If the symbol is red, this indicates a critical situation. You can check the specific cause of the problem by looking at the symbol(s) displayed in the Battery Status window (see Battery Status Window on page 251). Battery status indicator Battery malfunction indicator Alternates with the battery gauge on the Main Screen. Check in the Battery Status window to see which status symbol is displayed for which battery to identify the cause. The red ! flashes. Critical battery situation or malfunction. Check in the Battery Status window to see which malfunction indicator is displayed, or refer to the INOP, to identify the cause. Indicator for missing battery (flashing red X). An !! Insert Battery INOP is issued when the battery compartment is empty, and the monitor is connected to external power. This INOP is suppressed for 15 seconds while the monitor is connected to external power, allowing you sufficient time to insert new battery. After silencing, the INOP reappears every 10 seconds until a battery is inserted. Monitoring Time Available: While the monitor is running on battery power, a time is displayed below the battery power gauge. No time is displayed when the monitor is running on external power. This is the estimated monitoring time available with the current battery power. Note that this time fluctuates depending on the system load (the display brightness and how many measurements you carry out). If the remaining operating time is 00:00, the monitor shuts down automatically. Battery Status Window To access the Battery Status window and its associated pop-up keys, select the battery status information on the Screen, or select Main Setup then select Battery. If you are using a Battery Extension, status information for both batteries will be shown in the Battery Status window. If the battery in the Battery Extension is completely discharged, there may be no status information available for it. Capacity, remaining tells you how much power is left in the battery. Capacity, fullCharge tells you how much power the battery can hold when fully charged. TimeToEmpty tells you approximately how long you can continue to use the monitor with this battery. Note that this time fluctuates depending on the system load (the display brightness and how many measurements you carry out). TimeToFull is shown in place of TimeToEmpty if the monitor is connected to mains power via a host monitor or the M8023A external power supply, and tells you how much time is left until the battery is charged to 90%. You can use the 865432 Smart Battery Conditioner (previously M8043A) to charge the batteries externally. Battery status/malfunction symbols: If a problem is detected with the battery, an INOP may be issued, and the following symbols are displayed in the Battery Status window, where they may be accompanied by a battery status message providing more details. Messages appear in the line where TimeToFull/TimeToEmpty is shown. 251 21 Using Batteries Symbols indicating critical situations are colored red. Battery status symbols battery is empty Battery malfunction symbols
(red) incompatible battery battery not charging as the temperature is above or below the specified range
(red) battery malfunction battery requires maintenance
(red) battery has no power left charging stopped to protect the battery
(red) battery temperature too high Printing Battery Reports To print the information in the Battery Status window on a connected printer, 1 2 Select the battery status information on the Screen to open the Battery Status window Select the Print Status pop-up key. Checking Battery Charge To check the charge status of a battery, refer to the battery power gauge on the screen, or open the Battery Status window. When Battery Lifetime is Expired When the battery is aged, either after 3 years from manufacturing date or after 500 full charge/
discharge cycles, it is recommended to replace the battery. To remind you of this, a message will appear in the Battery Status window. This message will only be displayed at the appropriate time when the date and time on the monitor is correct. WARNING The risk of battery failure increases with age, when a battery remains in use longer than 3 years or 500 full charge-discharge cycles. Such failures can result in overheating that in rare cases can cause the battery to ignite or explode. 252 Replacing a Battery 21 Using Batteries To replace the battery, 1 Press the battery eject button. This releases the battery. Support the battery with your hand to prevent it from falling out. The INOP !! Insert Battery is suppressed for 15 seconds, allowing you sufficient time to insert a new battery. 2 Remove the battery from the compartment. 3 Slide the new battery into position with the contacts facing downwards. It should 'click' into position when it is fully inserted. WARNING Do not insert your fingers or any objects into the open battery compartment. 253 21 Using Batteries Replacing the Battery in the Battery Extension To replace the battery, 1 Push the battery cover downwards, so that it opens. 2 Remove the battery from the compartment. 3 Slide the new battery firmly into position with the label facing downwards. 4 Close the battery cover and push it upwards, so that it remains closed. Optimizing Battery Performance The performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process. 254 21 Using Batteries Display Brightness Setting 1 In the Main Setup menu, select User Interface, Brightness, then Optimum. This selects a level of brightness suitable for most monitoring locations that uses less battery power than brighter settings. 2 Ensure that the current level of brightness is suitable for your monitoring location. Charging a Battery Insert the battery into a monitor connected to the external power supply (M8023A). A battery can be charged in a monitor during monitoring. You can also use the 865432 Smart Battery Conditioner (previously M8043A) to charge batteries. 1 2 Charge the battery until it is full, the battery LED goes out, and the battery power gauge is filled. In certain situations, internal temperature conditions may mean that the battery will not charge. This is sometimes necessary to protect the battery from damage, and does not indicate a malfunction. In this case you must use the 865432 Smart Battery Conditioner (previously M8043A Smart Battery Conditioner) to charge the battery. Conditioning a Battery You must condition a battery when its "battery requires maintenance" symbol shows on the Screen. Do not interrupt the charge or discharge cycle during conditioning. You can condition a battery in a monitor. CAUTION Do not use a monitor that is being used to condition batteries to monitor patients. The monitor switches off automatically when there is no battery power left. It is, however, preferable to use the 865432 Smart Battery Conditioner (previously M8043A) for external battery conditioning. The Smart Battery Conditioner automatically performs the correct charge or conditioning process and evaluates the capacity when fully charged. For details please see the Instructions for Use for the Smart Battery Conditioner. Do not use any other battery chargers or conditioners. To condition a battery using a monitor, 1 Insert the battery into a monitor connected to the external power supply (M8023A) that is connected to mains power. Switch the monitor power off. 2 3 Charge the battery until it is completely full. Open the Battery Status window. Check that the Batt fully charged message is displayed. 4 Disconnect the monitor from mains power and let the monitor run until there is no battery power left and the monitor switches itself off. 5 Reconnect the monitor to mains power and charge the battery until it is full for use or charge to 50% for storage. To condition the battery from a Battery Extension, use the 865432 Smart Battery Conditioner. 255 21 Using Batteries Storing a Battery A battery should not remain inside the monitor or Battery Extension if it is not used for a longer period of time. If batteries are stored for an extended period of time, they should be stored in a cool place, ideally at 15C (60F), with a state of charge of 20% to 40%. Storing batteries in a cool place slows the aging process. The batteries should not be stored at a temperature outside the range of -20C
(-4F) to 60C (140F). Stored batteries should be partially charged to 20% to 40% of their capacity every 6 months. They should be charged to full capacity prior to use. Storing batteries at temperatures above 38C (100F) for extended periods of time could significantly reduce the batteries life expectancy. NOTE The battery will discharge over time if it is stored inside the monitor or Battery Extension when not connected to AC power via the external power supply (M8023A). The reported values for "remaining capacity" and "runtime" will become less accurate when the battery is stored in this way for a longer period of time (that is, several weeks). Disposing of Used Batteries Dispose of used batteries promptly and in an environmentally-responsible manner. Discharge the batteries and insulate the terminals with tape before disposal. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Battery Safety Information WARNING Use only Philips batteries specified in the chapter on Accessories. Use of a different battery may present a risk of fire or explosion. Do not open batteries, heat above 60C (140F), incinerate batteries, or cause them to short circuit. They may ignite, explode, leak or heat up, causing personal injury. If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified service personnel. Do not expose batteries to liquids. Do not apply reverse polarity. Do not crush, drop or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:
discontinue use dispose of the battery in accordance with the disposal instructions above. Keep batteries out of the reach of children Keep batteries in their original package until you are ready to use them. 256 22 22Maintenance and Troubleshooting WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories Perform a visual inspection before every use, and in accordance with your hospital's policy. With the monitor switched off:
1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. Inspect all accessories (cables, transducers, sensors and so forth). If any show signs of damage, or the use-by date has been exceeded, do not use. Switch the monitor on and make sure the backlight is bright enough. Check that screen is at its full brightness. If the brightness is not adequate, contact your service personnel or your supplier. 2 3 WARNING Electrical Shock Hazard: Do not open the monitor or measurement device. Contact with exposed electrical components may cause electrical shock. Always turn off and remove power before cleaning the sensor, monitor or measurement device. Do not use a damaged sensor or one with exposed electrical contacts. Refer servicing to qualified service personnel. 257 22 Maintenance and Troubleshooting Inspecting the Cables and Cords 1 Examine all system cables, the power plug and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace it with an appropriate Philips power cord. Inspect the patient cables, leads and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain. 2 3 Apply the transducer or electrodes to the patient, and with the monitor switched on, flex the patient cables near each end to make sure that there are no intermittent faults. Maintenance Task and Test Schedule The following tasks are for Philips-qualified service professionals only. All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the monitor documentation DVD. Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Type Monitor Tests Maintenance and Test Activities Safety checks. Selected tests on the basis of IEC 60601-1. Monitor Maintenance Check ECG synchronization of the monitor and defibrillator (only if hospital protocol requires use of monitor during defibrillation). Measurement Tests Performance assurance for all measurements Measurement Maintenance not listed below. NBP calibration Microstream CO2 calibration and performance test Mainstream and sidestream CO2 calibration and sidestream flow check Frequency At least once every two years, or as needed, after any repairs where the power supply is removed or replaced, or if the monitor has been dropped. At least once every two years, or as needed. At least once every two years, or if you suspect the measurement values are incorrect. At least once every two years, or as specified by local laws. At least once a year or after 4000 operating hours. At least once a year, or if you suspect the measurement values are incorrect. Battery Maintenance See Optimizing Battery Performance on page 254 for battery maintenance activities. Troubleshooting If you suspect a problem with an individual measurement, read the Instructions for Use and double-
check that you have set up the measurement correctly. If you suspect an intermittent, system-wide problem call your service personnel. You may be asked for information from the status log. To view the status log, In the Main Setup menu, select Revisions. 1 Select Status Log. 258 Disposing of the Monitor 22 Maintenance and Troubleshooting WARNING To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste. You can disassemble the monitor as described in the Service Guide. You will find detailed disposal information on the following web page:
http://www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpd The Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). Do not dispose of electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. Disposing of Empty Calibration Gas Cylinders 1 Empty the cylinder completely by pushing in the pin of the regulator valve or by pulling out the pin of the fill valve using a tire valve stem wrench or a pair of needle nose pliers. 2 When the cylinder is empty, either remove the valve stem from the fill (or regulator) hole, or drill a hole in the cylinder. 3 Write "Empty" on the cylinder and dispose of it appropriately for scrap metal. WARNING Ensure that the cylinder is completely empty before trying to remove the valve stem or drill a hole in the cylinder. 259 22 Maintenance and Troubleshooting 260 23 23Accessories This chapter lists Philips-approved accessories for use with patient monitors as described in this document. You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Some accessories may not be available in all countries. All accessories listed in this chapter comply, in combination with the patient monitor, with the requirements of IEC 60601-1-2. WARNING Reuse: Never reuse disposable transducers, sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard. Philips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. Packaging: Do not use a sterilized accessory if its packaging is damaged. Correct Use: Always follow the instructions for use supplied with the accessories. ECG/Resp Accessories This symbol indicates that the cables and accessories are designed to have special protection against electric shocks (particularly regarding allowable leakage currents), and are defibrillator proof. The following cables may not all be available in all countries. Please check availability with your local Philips supplier. Trunk Cables For use with:
3-Electrode Cable Set 3-Electrode Cable Set, OR 5-Electrode Cable Set 5-Electrode Cable Set, OR Part No. M1669A 989803170171 M1668A 989803170181 Length 2.7 m 2.7 m 2.7 m 2.7 m 261 23 Accessories For use with:
6-Electrode Cable Set 10-Electrode Cable set (5+5) 10-Electrode Cable set (6+4) 3-Electrode Cable Sets Part No. M1667A M1663A M1665A Length 2.7 m 2.7 m 2.7 m Description OR Grabber shielded ICU Grabber shielded ICU snap shielded ICU Clip non-shielded ICU Clip non-shielded Single Patient 3-Electrode Cable Sets Length 1.0 m 1.0 m 1.0 m 0.45 m 0.7 m AAMI Part No. M1675A M1671A M1673A M1622A M1624A IEC Part No. M1678A M1672A M1674A
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M1626A Description ICU Grabber shielded ICU Grabber shielded 5-Electrode Cable Sets Length 1.0 m 0.84 m AAMI Part No. 989803173121 989803173141 IEC Part No. 989803174201
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Description OR Grabber shielded ICU Grabber shielded ICU Snap shielded ICU Miniclip non-shielded Single Patient 5-Electrode Cable Sets Length 1.0 m/1.6 m 1.0 m/1.6 m 1.0 m/1.6 m 0.7 m/1.3 m AAMI Part No. M1973A M1968A M1644A M1647A IEC Part No. M1974A M1971A M1645A M1648A Description ICU Grabber shielded ICU Grabber shielded 6-Electrode Cable Sets Description OR Grabber ICU Grabber ICU Snap 262 Length 1.0 m 0.85 m AAMI Part No. 989803173131 989803173151 IEC Part No. 989803174211
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Length 1.0 m/1.6 m 1.0 m/1.6 m 1.0 m/1.6 m AAMI Part No. M1684A M1680A M1682A IEC Part No. M1685A M1681A M1683A 10-Electrode (5+5) Cable Sets Description ICU Grabber, chest, shielded ICU Snap, chest, shielded OR Grabber, chest, shielded For Limb Leads see 5-electrode cable sets 10-Electrode (6+4) Cable Sets Length 1.0 m 1.0 m 1.0 m Description ICU Grabber, chest, shielded ICU Snap, chest, shielded OR Grabber, chest, shielded For Limb Leads see 6-electrode cable sets One-piece Cables Description 3-lead Grabber, ICU 5-lead Grabber, ICU Radio-translucent Cables Length 1.0 m 1.0 m 1.0 m Length 1.0 m 1.0 m 23 Accessories AAMI Part No. M1976A M1602A M1979A IEC Part No. M1978A M1604A M1984A AAMI Part No. M1532A M1537A M1557A IEC Part No. M1533A M1538A M1558A AAMI Part No. 989803143181 989803143201 IEC Part No. 989803143171 989803143191 Pack of five single wires, radio-translucent, 0.9 m, M1649A Set Combiners and Organizers Description Set combiner Set organizer for shielded leadsets - grabber and snap Set organizer for non-shielded lead sets - miniclip Bedsheet clip Replacement red cover for trunk cable (for 5-electrode cable sets) 3-electrode 5-electrode 3-electrode 4-electrode 5-electrode 6-electrode 3-electrode 5-electrode Part No. M1501A M1502A M1503A M1664A M1504A M1679A M1636A M1638A M1509A 989808148861 263 23 Accessories 5-Electrode One Piece Cables Length Description 2.5 m OR Grabber 2.5 m ICU Snap Set Combiners and Organizers Description Set combiner Set organizer Bedsheet clip NBP Accessories AAMI Part No. M1975A M1977A IEC Part No. M1985A M1986A Part No. M1501A 3-electrode M1502A 5-electrode Shielded 3-electrode M1503A Shielded 5-electrode M1504A M1509A These cuffs and tubings are designed to have special protection against electric shocks
(particularly regarding allowable leakage currents), and are defibrillator proof. You can use them during electrosurgery. Adult/Pediatric Reusable Comfort Care Cuffs Patient Category Adult (Thigh) Large Adult Large Adult XL Adult Adult XL Small Adult Small Adult XL Pediatric Infant Adult/Pediatric Reusable Comfort Care Cuff Kits Limb Circumference 42 to 54 cm 34 to 43 cm 34 to 43 cm 27 to 35 cm 27 to 35 cm 20.5 to 28 cm 20.5 to 28 cm 14 to 21.5 cm 10 to 15 cm Part No. M1576A M1575A M1575XL M1574A M1574XL M1573A M1573XL M1572A M1571A Cuff Kits Infant, pediatric, small adult, adult Small adult, adult, large adult, thigh Infant, pediatric, small adult, adult, large adult, thigh Small adult XL, adult XL, large adult XL 264 Tubing M1598B (1.5 m) or M1599B (3 m) Part No. M1577A M1578A M1579A M1579XL 23 Accessories Tubing M1598B (1.5 m) or M1599B (3 m) Adult/Pediatric Reusable Easy Care Cuffs Patient Category Limb Circumference Part No. Adult Thigh Large Adult X-Long Large Adult Adult X-Long Adult Small Adult Pediatric Infant Adult/Pediatric Reusable Easy Care Cuff Kits 44 - 56 cm 35 - 45 cm 35 - 45 cm 27.5 - 36 cm 27.5 - 36 cm 20.5 - 28.5 cm 14 - 21.5 cm 10 - 15 cm
(Pack of five) M4559B (M4559B5) M4558B (M4558B5) M4557B (M4557B5) M4556B (M4556B5) M4555B (M4555B5) M4554B (M4554B5) M4553B (M4553B5) M4552B (M4552B5) Cuff Kits Assortment pack of one small adult, one adult, one large adult and one thigh cuff Assortment pack of one infant, one pediatric, one small adult and one adult cuff Assortment pack of one infant, one pediatric, one small adult, one adult, one large adult and one thigh cuff Assortment pack of one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff Adult/Pediatric Multi Care Cuffs Part No. 864288 864289 864290 864291 Patient Category Adult Thigh Large Adult Large Adult X-Long Adult Small Adult Pediatric Infant Limb Circumference Part No. 42.0 - 54.0 cm 34.0 - 43.0 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 20.5 - 28.0 cm 14.0 - 21.5 cm 10.0 - 15.0 cm 989803183371 989803183361 989803183351 989803183341 989803183331 989803183321 989803183311 Tubing M1598B (1.5 m) or M1599B (3 m) 265 23 Accessories Adult/Pediatric Single Patient, Gentle Care Cuffs Tubing M1598B (1.5 m) or M1599B (3 m) Tubing M1598B (1.5 m) or M1599B (3 m) Tubing M1598B (1.5 m) or M1599B (3 m) Patient Category Adult (Thigh) Large Adult X-Long Large Adult Adult X-Long Adult Small Adult Pediatric Infant Adult/Pediatric Single Care Cuffs Limb Circumference 44 - 56 cm 35 - 45 cm 35 - 45 cm 27.5 - 36 cm 27.5 - 36 cm 20.5 - 28.5 cm 14.0 - 21.5 cm 10 - 15 cm Part No. M4579B M4578B M4577B M4576B M4575B M4574B M4573B M4572B Patient Category Large Adult Adult X-Long Adult Small Adult Pediatric Adult/Pediatric Value Care Cuffs Limb Circumference 35.0 - 45.0 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 20.5 - 28.5 cm 14.0 - 21.5 cm Part No. 989803182321 989803182311 989803182301 989803182291 989803182281 Patient Category Large Adult Adult XL Adult Small Adult Pediatric Infant Limb Circumference Part No. 34.0 - 43.0 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 20.5 - 28.0 cm 14.0 - 21.5 cm 10.0 - 15.0 cm 989803160861 989803160851 989803160841 989803160831 989803160821 989803160811 266 23 Accessories Neonatal/Infant Single Patient Cuffs Cuffs Limb Circumference Size 1 Size 2 Size 3 Size 4 Size 5 (Infant) 3.1 to 5.7 cm 4.3 to 8.0 cm 5.8 to 10.9 cm 7.1 to 13.1 cm 10 to 15 cm Part No. A - Luer connector B - ISO 80369-1 compliant connector M1866A/B M1868A/B M1870A/B M1872A/B M1873B Tubing For A-version cuffs:
M1596B (1.5 m) or M1597B
(3 m) For B-version cuffs:
M1596C (1.5 m) or M1597C
(3 m) Neonatal/Infant Single Patient, Soft Cuffs Limb Circumference Cuffs 3.1 to 5.7 cm Size 1 4.3 to 8.0 cm Size 2 5.8 to 10.9 cm Size 3 7.1 to 13.1 cm Size 4 10 to 15 cm Size 5 (Infant) Neonatal/Infant Cuff Kits Part No. M1866S M1868S M1870S M1872S M1873S Tubing M1596C (1.5 m) or M1597C (3 m) Cuff Kits Standard, Single Patient, Luer connector: 10 x M1866A, 10 x M1868A, 10 x M1872A, and 20 x M1870A Standard, Single Patient, ISO 80369-1 compliant connector: 5 x M1866B, 10 x M1868B, 20 x M1870B, 10 x M1872B, and 5 x M1873B Soft, Single Patient, ISO 80369-1 compliant connector: 5 x M1866S, 10 x M1868S, 20 x M1870S, 10 x M1872S, 5 x M1873S IntelliVue CL NBP Pod Accessories Part No. M1820-60020 989803167541 989803167551 Mobile CL Cuffs and Accessories Part Number Description 989803163171 989803163191 989803163211 Mobile CL Reusable Small Adult Cuff Mobile CL Reusable Adult Cuff 26.0 - 34.5 cm 33.5 - 45.0 cm Mobile CL Reusable Large Adult Cuff Limb Circumference Range 21 - 27 cm Bladder Width Contents 10.5 cm 13.0 cm 16.0 cm 1 cuff 1 cuff 1 cuff 267 23 Accessories Part Number Description 989803163181 989803163201 989803163221 989803163251 989803163131 989803187431 989803163261 Mobile CL Single-Patient Small Adult Cuff Mobile CL Single-Patient Adult Cuff Mobile CL Single-Patient Large Adult Cuff Mobile CL NBP Cradle Kit Mobile CL Extension Air Hose, 1.0 m Mobile CL Air Hose - Bayonet Connector Mobile CL NBP Battery Kit
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989803137831 989803140371 Telemetry Pouch with window -
Telemetry Pouch with window -
989803101971
(9300-0768-050) 989803101981
(9300-0768-200) White Telemetry Pouch with Snaps; box of 50 White Telemetry Pouch with Snaps; 4 boxes of 50
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Comfort Reusable Cuffs Part Number M1571A M1572A M1573A M1574A M1575A M1576A M1577A M1578A M1579A Description Infant cuff Pediatric cuff Small adult cuff Adult cuff Large adult cuff Thigh cuff Kit of small cuffs (M1571A to M1574A) Kit of large cuffs (M1573A to M1576A) Kit of all cuffs (M1571A to M1576A) Easy Care Reusable Cuffs Part Number M4552B M4552B5 268 Description Infant cuff Pack of 5 M4552B cuffs Bladder Width Contents Limb Circumference Range 21 - 27 cm 10.5 cm 26.0 - 34.5 cm 13.0 cm 33.5 - 45.0 cm 16.0 cm 20 cuffs 20 cuffs 20 cuffs 20 cradles 1 extension air hose 1 adapter air hose 1 Battery 1 disassembly tool 1 front housing 50 pouches 4 boxes of 50 pouches 50 pouches 4 boxes of 50 pouches
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Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.0 cm 27.0 - 35.0 cm 34.0 - 43.0 cm 42.0 - 54.0 cm Limb Circumference Range 10.0 - 15.0 cm 23 Accessories Limb Circumference Range 14.0 - 21.5 cm 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm 35.0 - 45.0 cm 44.0 - 56.0 cm Part Number M4553B M4553B5 M4554B M4554B5 M4555B M4555B5 M4556B M4556B5 M4557B M4557B5 M4558B M4558B5 M4559B M4559B5 864288 864289 864290 864291 Description Pediatric cuff Pack of 5 M4553B cuffs Small adult cuff Pack of 5 M4554B cuffs Adult cuff Pack of 5 M4555B cuffs Adult cuff, X-Long Pack of 5 M4556B cuffs Large adult cuff Pack of 5 M4557B cuffs Large adult cuff, X-Long Pack of 5 M4558B cuffs Thigh cuff Pack of 5 M4559B cuffs Assortment pack of one small adult, one adult, one large adult and one thigh cuff Assortment pack of one infant, one pediatric, one small adult and one adult cuff Assortment pack of one infant, one pediatric, one small adult, one adult, one large adult and one thigh cuff Assortment pack of one small adult, one adult, one adult X-
long, one large adult, one large adult X-long and one thigh cuff Multi Care Cuffs Part Number 989803183311 989803183321 989803183331 989803183341 989803183351 989803183361 989803183371 Description Infant cuff Pediatric cuff Small adult cuff Adult cuff Adult cuff, X-Long Large adult cuff Thigh cuff Single Patient, Gentle Care Cuffs Part Number M4572B M4573B Description Infant cuff Pediatric cuff Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 20.5 - 28.0 cm 27.0 - 35.0 cm 27.0 - 35.0 cm 34.0 - 43.0 cm 42.0 - 54.0 cm Limb Circumference Range 10.0 - 15.0 cm 14.0 - 21.5 cm 269 23 Accessories Part Number M4574B M4575B M4576B M4577B M4578B M4579B Description Small adult cuff Adult cuff Adult cuff, X-Long Large adult cuff Large adult cuff, X-Long Thigh cuff Single Care Cuffs Part Number 989803182281 989803182291 989803182301 989803182311 989803182321 Description Pediatric cuff Small adult cuff Adult cuff Adult cuff, X-Long Large adult cuff Limb Circumference Range 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm 35.0 - 45.0 cm 44.0 - 56.0 cm Limb Circumference Range 14.0 - 21.5 cm 20.5 - 28.5 cm 27.5 - 36.0 cm 27.5 - 36.0 cm 35.0 - 45.0 cm Invasive Pressure Accessories These transducers and accessories are designed to have special protection against electric shocks (particularly regarding allowable leakage currents), and are defibrillator proof. If you are using the M3012A Hemodynamic MMS Extension, and you want to measure temperature and invasive pressure at the same time, we recommend that you use the pressure transducer CPJ840J6, with a round module connector piece, and not a transducer with a square connector. Pressure transducers with square connectors may make it difficult to connect the adjacent Temperature connector at the same time. Pressure transducers and accessories Reusable pressure transducer 5 V/V/mmHg sensitivity Sterile disposable pressure domes for CPJ840J6 (pack of 50) Transducer holder for CPJ840J6 (pack of 4) IV pole mount for CPJ840J6 Monitoring Line Set for CPJ840J6 Single channel disposable sensor kit (20) (EU/EFTA only) Dual channel disposable sensor kit (20) (EU/EFTA only) Transducer holder for M1567/8A (EU/EFTA only) IV pole mount for M1567/8A (EU/EFTA only) Adapter cable for disposable sensor kit 3.0 m for M1567/8A 270 Part No. CPJ840J6 CPJ84022 CPJ84046 CPJ84447 CPJ84026 M1567A M1568A M2271A M2272C M1634A 23 Accessories Part No. PV8103 Pressure transducer kits PiCCO monitoring kit, 30 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A PiCCO monitoring kit, 150 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A PiCCO monitoring kit, 150 cm pressure line, includes PV4046 injectate temperature sensor housing for M1646A and central venous pressure line PULSION Pressure Interface Cable for disposable pressure transducer Transpac 4 Disposable Pressure Transducer Pressure Monitoring Kits PV8115CVP PMK 206 PV8115 Transducer Pressure Monitoring Kits with SafeSet Blood Sampling/Conservation System Description Single DPT TP4 with SafeSet, 2 Cannula Sampling Ports, In-line Reservoir Single DPT TP4 with SafeSet, 2 Luer Sampling Ports, In-line Reservoir Single DPT TP4 with SafeSet, 1 Cannula Sampling Port, In-line Reservoir Single DPT TP4 with SafeSet, 2 Cannula Sampling Ports, In-line Reservoir Single DPT TP4 with SafeSet, 2 Luer Sampling Ports, In-line Reservoir Single DPT TP4 with SafeSet, Patient Mount, 1 Cannula Sampling Port, In-line Reservoir Dual DPT TP4 with SafeSet, (Clear/Blue dash tubing) 2 Cannula Sampling Ports, In-line Reservoir Dual DPT TP4 with SafeSet, (Clear/Blue dash tubing) 2 Luer Sampling Ports, In-line Reservoir Triple DPT TP4 with SafeSet, 2 Cannula Sampling Ports, In-line Reservoir Triple DPT TP4 with SafeSet, 2 Luer Sampling Ports, In-line Reservoir Length 213 cm (84 in) 213 cm (84 in) 152 cm (60 in) 152 cm (60 in) 152 cm (60 in) 61 cm (24 in) 213 cm (84 in) 213 cm (84 in) 213 cm (84 in) 213 cm (84 in) Transpac and SafeSet are trademarks of ICU Medical, Inc. Quantity
(per box) 20 20 20 20 20 20 10 10 10 10 Part No. 989803179741 989803179751 989803179761 989803179781 989803179791 989803179861 989803179801 989803179811 989803179821 989803179831 271 23 Accessories Safeset Blood Sampling/Conservation System Description SafeSet Kit with tubing, 1 In-line Cannula Sampling Port and 10 ml In-line Reservoir SafeSet Kit with tubing, 2 In-line Cannula Sampling Ports and 10 ml In-line Reservoir
(Transducer not contained in kit) Length 152 cm (60 in) Quantity
(per box) 20 Part No. 989803180851 213 cm (84 in) 20 989803179891 Transpac 4 Disposable Pressure Transducer Pressure Monitoring Kits Drip Chamber Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Macrodrip Description Stopcocks Primary Tubing Length Extension Tubing length Flush Device Two 3-way 122 cm (48 in) 31 cm (12 in) Four 3-way 152 cm (60 in) 31 cm (12 in) 3 ml/hr, Squeeze Two 3 ml/hr, Squeeze Two 3-way 183 cm (72 in) 31 cm (12 in) Six 3-way 122 cm (48 in) 31 cm (12 in) Two 3-way 152 cm (60 in) 31 cm (12 in) One 3-way 23 cm (9 in) 61 cm (24 in) One 4-way One 3-way Two 3-way 122 cm (48 in) 31 cm (12 in) Two 3-way 152 cm (60 in) 31 cm (12 in) Two 3-way 183 cm (72 in) 31 cm (12 in) Four 3-way 152 cm (60 in) 31 cm (12 in) Six 3-way 122 cm (48 in) 31 cm (12 in) Two 3-way 61 cm (24 in) Three 3-
way Three 3-way 31 cm (12 in) 46 cm (18 in) 3 ml/hr, Squeeze 3 ml/hr, Squeeze 3 ml/hr, Squeeze 3 ml/hr, Squeeze No flush device 3 ml/hr, Squeeze 3 ml/hr, Squeeze 3 ml/hr, Squeeze 3 ml/hr, Squeeze 3 ml/hr, Squeeze 30 ml/hr Squeeze 30 ml/hr Squeeze 30 ml/hr Squeeze Single DPT TP4, (152 cm, 60 in) Red dash tubing Dual DPT TP4, (183 cm, 72 in) Red/Blue dash tubing Single DPT TP4, (213 cm, 84 in) Red dash tubing Triple DPT TP4, (152 cm, 60 in) Single DPT TP4, (183 cm, 72 in) Red dash tubing Single DPT TP4, (23 cm, 9 in) Patient Mount Single DPT TP4, (61 cm, 24 in) Compartmental Pressure Single DPT TP4, (152 cm, 60 in), Premium Stripe Single DPT TP4, (183 cm, 72 in), Premium Stripe Single DPT TP4, (213 cm, 84 in), Premium Stripe Dual DPT TP4, (183 cm, 72 in), Premium Stripe Triple DPT TP4, (152 cm, 60 in), Premium Stripe Single Neonatal DPT TP4 (61 cm, 24 in) Single Neonatal DPT TP4 (31 cm, 12 in) Single Neonatal DPT TP4 (46 cm, 18 in) one in-
line Luer sampling port &
10 ml In-line reservoir 272 Quantity
(per box) Part No. 20 10 20 10 20 20 20 20 20 20 10 10 20 20 20 989803177901 989803177911 989803179721 989803179731 989803179771 989803179871 989803181141 989803181211 989803181221 989803181231 989803181241 989803181251 989803179841 989803179851 989803179881 Transpac 4 and Safeset Cables and Accessories Description Cable for Philips Monitors 3 m (10 ft) Cable for Philips Monitors 4.5 m (15 ft) Cable for Philips Monitors 4.5 m (15 ft) Trifurcated Cable for Philips Monitors 4.5 m (15 ft) 3-Position Transducer Mount Transducer Holder for IV Pole Single Transducer Mount SafeSet Mounting Bracket Safeset Shielded Blunt Cannula SafeSet Shielded Blunt Cannula with Blood Tube Holder Extension tube, 30 cm Extension tube, 60 cm Extension tube, 90 cm SpO2 Accessories Quantity (per box) 1 1 20 1 28 5 30 30 50 25 25 25 25 23 Accessories Part No. 989803177921 989803179941 989803179951 989803179961 989803177931 989803177941 989803179911 989803179901 989803179921 989803179931 989803184971 989803184981 989803184991 Some Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension cable with:
Masimo adapter cables, Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "Long"
version) or with a cable longer than 2 m. All listed sensors operate without risk of exceeding 41C on the skin, if the initial skin temperature does not exceed 35C. Make sure that you use only the accessories that are specified for use with your monitor and measurement technology, otherwise patient injury can result. Familiarize yourself with the instructions for use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. Incorrect sensor application or use may result in inaccurate measurements. In the accessory tables, a column indicates which SpO2 technologies the sensors can be used with, Philips FAST SpO2 (P), or Nellcor OxiMax (N). 273 23 Accessories Philips Reusable Sensors Product Number M1191A/B M1191AL/BL M1192A M1193A M1194A M1195A M1196A M1196S M1191T M1192T M1193T M1196T Philips Nellcor P P P P P P P P P P P P Description Adult sensor (2 m cable), for patients over 50 kg. Any finger, except thumb. M1191A/B with longer cable (3 m) Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Neonatal sensor (1.5 m cable) for patients between 1 kg and 4 kg. Hand or foot. Ear sensor (1.5 m cable) for patients over 40 kg. Infant sensor (1.5 m cable) for patients between 4 kg and 15 kg. Any finger except thumb. Adult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. Adult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. Adult sensor (0.45 m cable), for patients over 50 kg. Any finger, except thumb. Small adult, pediatric sensor (0.45 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Neonatal sensor (0.9 m cable) for patients between 1 kg and 4 kg. Hand or foot. Adult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. Philips Disposable Sensors Comments No adapter cable required. Requires M1943A (1 m) or M1943AL (3 m) adapter cable Product Number M1901B1 M1902B1 M1903B1 M1904B1 M1131A M1132A M1133A 274 Philips Nellcor P,N P,N P,N P,N P P P Description Comments Identical to OxiMax MAXN Identical to OxiMax MAXI Identical to OxiMax MAXP Identical to OxiMax MAXA Adult/Pediatric finger sensor, 0.45 m cable
(patient size > 20 kg) Infant finger or toe sensor, 0.9 m cable
(patient size 3 - 10 kg) Adult/Infant/Neonatal, 0.9 m cable Foot or hand for neonates < 3 kg Big toe or thumb for patients between 10 kg and 20 kg Any finger except thumb for patients > 40 kg For Philips FAST SpO2: use M1943A (1 m) or M1943AL
(3 m) adapter cable. For Nellcor OxiMax SpO2:
use M1943NL adapter cable. Use M1943A or M1943AL adapter cable. Use M1943A or M1943AL adapter cable. Use M1943A or M1943AL adapter cable. 23 Accessories Product Number M1134A Philips Nellcor P Description Comments Adhesive-free, Adult/Infant/Neonatal, 0.9 m cable Foot or hand for neonates < 3 kg Big toe or thumb for patients between 10 kg and 20 kg Any finger except thumb for patients > 40 kg Use M1943A or M1943AL adapter cable. 1Not available in the USA, Canada and Japan. Nellcor Sensors Nellcor sensors must be ordered from Nellcor/Covidien. Product Number OxiMax MAX-A OxiMax MAX-AL OxiMax MAX-P OxiMax MAX-I OxiMax MAX-N Oxisensor II D-25 Oxisensor II D-20 Oxisensor II I-20 Oxisensor II N-25 Oxicliq A Oxicliq P Oxicliq I Oxicliq N MAX-R MAXFAST Oxiband OXI-A/N Oxiband OXI-P/I SC-A SCNEO-I SC-PR-I DS100A-I Dura-Y D-YS Philips Nellcor P,N P,N P,N P,N P,N P P P P P,N P,N P,N P,N N N N N N N N N N Description Adult finger sensor (patient size > 30 kg) OxiMax MAX-A with long cable Pediatric foot/hand sensor (patient size 10 - 50 kg) Infant foot/hand sensor (patient size 3 - 20 kg) Adult finger or neonatal foot/hand sensor (patient size
> 40 kg or < 3 kg) Adult sensor (patient size > 30 kg) Pediatric sensor (patient size 10 - 50 kg) Infant sensor (patient size 3 - 20 kg) Neonatal sensor (patient size < 3 kg or > 40 kg) See OxiMax MAXA See OxiMax MAXP See OxiMax MAXI See OxiMax MAXN Adult SpO2 Nasal Sensor Forehead SpO2 Sensor Adult/Neonatal SpO2 Sensor with Wraps Pediatric-Infant SpO2 Sensor with Wraps Adult SpO2 Sensor Neonatal SpO2 Sensor Preemie SpO2 Sensor Adult SpO2 Sensor SpO2 Sensor Comments For Philips FAST SpO2: use M1943A or M1943AL adapter cable. For Nellcor OxiMax SpO2: use M1943NL adapter cable. Use M1943A or M1943AL adapter cable. For Philips FAST SpO2: use M1943A or M1943AL adapter cable together with OC-3. For Nellcor OxiMax SpO2: use M1943NL adapter cable together with OC-3. Use M1943NL adapter cable. 275 23 Accessories Extension Cables and Adapter Cables for Philips and Nellcor Sensors Product Number M1941A M1943A M1943AL M1943NL Philips Nellcor P Description Extension cable (2 m) P P N Adapter cable (1.1 m cable) Adapter cable (3 m cable) OxiMax adapter cable (3 m cable) OC-3 Masimo Sensors P,N Adapter Cable for Oxicliq sensors Comments For use with Philips reusable sensors
(with cable length 2 m) and M1943A adapter cable. Adapter cable for Philips/Nellcor disposable sensors. Adapter cable for Philips disposable/
Nellcor disposable and reusable sensors. Available from Nellcor/Covidien only. The monitor with Philips FAST SpO2 and Masimo Sensors uses Masimo certified pulse oximetry for reduced noise and low perfusion performance under the Masimo NR&LP protocol. Masimo sensors must be ordered from Masimo or from Masimo's distributors. LNOP Reusable Sensors Product Number LNOP DCI LNOP DCIP LNOP YI LNOP TC-I Philips Nellcor P P P P Description Adult Finger Sensor (> 30 kg) Pediatric Finger Sensor (10 - 50 kg) Multi-Site Sensor (> 1 kg) Ear Sensor (> 30 kg) LNCS Reusable Sensors Product Number LNCS DCI LNCS DCIP LNCS YI LNCS TC-I Philips Nellcor P P P P Description Adult Finger Sensor (> 30 kg) Pediatric Finger Sensor (10 - 50 kg) Multi-Site Sensor (> 1kg) Ear Sensor (> 30 kg) 276 23 Accessories LNOP Disposable Adhesive Sensors Product Number LNOP Adt LNOP Adtx LNOP Pdt LNOP Pdtx LNOP Inf-L LNOP Neo-L LNOP NeoPt-L Philips Nellcor P P P P P P P Description Adult Sensor (> 30 kg) Adult Sensor (> 30 kg) Pediatric Sensor (10 - 50 kg) Pediatric Sensor (10 - 50 kg) Infant Toe Sensor (3 - 20 kg) Neonatal Sensor (< 3 kg) or Adult adhesive Sensor (> 40 kg) Neonatal Pre-Term Sensitive Skin Sensors (< 1 kg) LNCS Disposable Adhesive Sensors Product Number LNCS Adtx LNCS Adtx-3 LNCS Pdtx LNCS Pdtx-3 LNCS Inf LNCS Inf-3 LNCS Neo LNCS Neo-3 LNCS NeoPt LNCS NeoPt-3 Philips Nellcor P P P P P P P P P P Description Adult Finger Sensor, 18 inch/45 cm (> 30 kg) Adult Finger Sensor, 3 feet/90 cm (> 30 kg) Pediatric Finger Sensor, 18 inch/45 cm (10 - 50 kg) Pediatric Finger Sensor, 3 feet/90 cm (10 - 50 kg) Infant Toe Sensor, 18 inch/45 cm (3 - 20 kg) Infant Toe Sensor, 3 feet/90 cm (3 - 20 kg) Neonatal Foot Sensor, 18 inch/45 cm (< 3 kg) or Adult Finger Sensor 18 inch/45 cm (> 40 kg) Neonatal Foot Sensor, 3 feet/90 cm (< 3 kg) or Adult Finger Sensor, 3 feet/90 cm (> 40 kg) Neonatal pre-term sensitive skin Sensor 18 inch/45 cm (< 1 kg) Neonatal pre-term sensitive skin Sensor 3 feet/90 cm (< 1 kg) Adapter Cables for Masimo Sensors Product Number LNOP MP12 LNOP MP10 Philips Nellcor P P Description Philips Part Number LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP Sensors LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS Sensors 451261000761 989803148221 277 23 Accessories IntelliVue CL SpO2 Pod Accessories All listed sensors operate without risk of exceeding 41C on the skin, if the initial skin temperature does not exceed 35C. Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result. Part Number 989803165941 989803165921 9898031659311 989803165951 989803165961 989803168861 Description Mobile CL 20 single patient SpO2 Sensors and Cradles for use on pediatric and adult patients >10 kg Contents 20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled 20 Single-Patient Mobile CL DSpO2-1A Sensors 1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands Mobile CL 20 single patient SpO2 Sensors for use on pediatric and adult patients >10 kg Mobile CL reusable SpO2 Sensor and Cradles for use on pediatric and adult patients
> 15 kg Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached Mobile CL 50 SpO2 Wristbands (single patient) Mobile CL SpO2 Battery Kit Wristbands 50 Single-Patient Wristbands 1 Battery 1 disassembly tool 1 front housing Part No. 21075A 21076A 21078A Part No. M1837A 21091A 21093A 21094A 21095A Minimum measurement time for accurate readings 90 sec 60 sec 60 sec Minimum measurement time for accurate readings 90 sec 60 sec 180 sec 210 sec 310 sec 1 May not be available in all geographies Temperature Accessories Reusable Temperature Probes General purpose probe Small flexible vinyl probe (Infant/Pediatric) Attachable surface probe Disposable Temperature Probes General purpose probe Skin probe Esophageal/Stethoscope Probe (French 12) Esophageal/Stethoscope Probe (French 18) Esophageal/Stethoscope Probe (French 24) 278 Disposable Temperature Probes Esophageal/Rectal Probe (French 12) Foley Catheter Probe (12 French) Foley Catheter Probe (16 French) Foley Catheter Probe (18 French) Adapter cable 1.5 m Adapter cable 3.0 m Part No. 21090A M2255A 21096A 21097A 21082B 21082A Combined Temperature Probes/Feeding Tubes Part No. InnerSense Esophageal Temperature / Feeding Tube, purple (5 French) InnerSense Esophageal Temperature / Feeding Tube, purple (6.5 French) InnerSense Esophageal Temperature / Feeding Tube, purple (8 French) InnerSense Esophageal Temperature / Feeding Tube, orange (5 French) InnerSense Esophageal Temperature / Feeding Tube, orange (6.5 French) InnerSense Esophageal Temperature / Feeding Tube, orange (8 French) 989803183631 989803183641 989803183651 989803183561 989803183571 989803183581 Mainstream CO2 Accessories Description CO2 Sensor Adult/Pediatric Airway Adapter (reusable) Infant Airway Adapter (reusable) Adult Airway Adapter (single-patient use) Infant Airway Adapter (single-patient use) Sidestream CO2 Accessories Description CO2 Sensor 23 Accessories Minimum measurement time for accurate readings 90 sec 180 sec 180 sec 180 sec
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Response Time per ISO 80601-2-56
< 150 seconds Part No. M2501A M2513A M2516A M2533A M2536A Part No. M2741A 279 23 Accessories Nasal and Oral-Nasal Cannulas CO2 Nasal Cannula, Adult CO2 Nasal Cannula, Pediatric CO2 Nasal Cannula, Infant CO2/O2 Nasal Cannula, Adult CO2/O2 Nasal Cannula, Pediatric CO2/O2 Nasal Cannula, Infant CO2 Oral-Nasal Cannula, Adult CO2 Oral-Nasal Cannula, Pediatric CO2/O2 Oral-Nasal Cannula, Adult CO2/O2 Oral-Nasal Cannula, Pediatric Airway Adapters Airway Adapter Set, ET > 4.0 mm Airway Adapter Set, ET 4.0 mm Airway Adapter Set H, ET > 4.0 mm Airway Adapter Set H, ET 4.0 mm Straight Sample Lines Straight Sample Line Straight Sample Line H Microstream CO2 Accessories Part No. M2744A M2745A M2746A M2750A M2751A 989803144471 M2756A M2757A M2760A M2761A Part No. M2768A 989803144531 M2772A M2773A Part No. M2776A M2777A
"FilterLine Set" is a combination of a FilterLine with an Airway Adapter.
"H" in the accessory name indicates suitability for humidified ventilation and longer usage due to the active removal of humidity from the sample line.
"Smart CapnoLine" is a combined oral-nasal FilterLine.
"Smart CapnoLine O2" is a combined oral-nasal-O2-CO2 FilterLine.
"NIV Line" is a nasal FilterLine suitable for mask ventilation (for example, C-PAP). The accessories are supplied in packs of 25. NOTE Not all accessories are available in all countries. Accessories for Intubated Patients Part Number FilterLine SET Adult/Pediatric FilterLine H SET Adult/Pediatric FilterLine H SET Infant/Neonatal 280 M1920A M1921A M1923A Part Number for Long Version 989803160241 989803160251 989803160261 Accessories for Intubated Patients VitaLine H SET Adult/Pediatric VitaLine H SET Infant/Neonate Accessories for Non-Intubated Patients CapnoLine H Adult CapnoLine H Pediatric CapnoLine H Infant/Neonatal CapnoLine H O2 Adult CapnoLine H O2 Pediatric CapnoLine H O2 Infant/Neonatal NIV Line Adult NIV Line Pediatric Nasal FilterLine Infant/Neonatal Nasal Filterline O2 Adult Nasal Filterline O2 Pediatric Smart CapnoLine O2 Adult Smart CapnoLine H O2 Adult Smart CapnoLine O2 Pediatric Smart CapnoLine H O2 Pediatric Smart CapnoLine Adult Smart CapnoLine Pediatric Accessories for Endoscopic Procedures Smart CapnoLine Guard Smart CapnoLine Guard O2 Hook and Loop Strap Battery Accessories 23 Accessories Part Number for Long Version Part Number for Long Version 989803178011 989803179111 989803160281 989803177961 989803160271 989803177981 989803160301 989803178051 Part Number 989803159571 989803159581 Part Number M4689A M4690A M4691A M4680A M4681A 989803178001 M4686A M4687A 989803178021 989803179101 989803179121 M2522A 989803177951 M2520A 989803177971 M2526A M2524A 989803178031 989803178041 989803178071 Description Lithium Ion Smart Battery 1Ah (internal battery for X2/MP2) Lithium Ion Smart Battery 6Ah (for 865297 Battery Extension) Battery Charger and Conditioner (requires size adapter 4512 610 17451 to charge M4607A battery) Size adapter for M4607A battery Part No. M4607A M4605A 865432 4512 610 17451 281 23 Accessories 282 24 24Specifications The specifications in this section apply to the MP2 patient monitor. Indications for Use The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. Use Environment Hospital Environment The monitor is suitable for use in all medically used rooms which fulfill the requirements regarding electrical installation according to IEC 60364-7-710 "Requirements for special installations or locations
- Medical locations", or corresponding local regulations. EMC Environment All measurements (except the sidestream CO2 measurement with M2741A sensor) and system interfaces (except short range radio and wireless LAN) are, in addition, suitable for use in establishments directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes (see table in Electromagnetic Emissions on page 312). The monitor is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. 283 24 Specifications WARNING The monitor is not intended for use in an MRI environment or in an oxygen-enriched environment
(for example, hyperbaric chambers). Restricted Availability Following new features and functionality may not be available in all geographies:
Cableless Respiration Measurement Integrated Pulmonary Index for Microstream CO2 IntelliVue Information Center iX Manufacturer's Information You can write to Philips at this address Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 71034 Boeblingen Germany Visit our website at: www.healthcare.philips.com. Copyright 2015. Koninklijke Philips N.V. All Rights Reserved. Trademark Acknowledgement Microstream, FilterLine, and Smart CapnoLine are trademarks or registered trademarks of Oridion Systems Ltd. Nellcor, Durasensor, Dura-Y, Oxiband, Oxicliq, OxiMax, MAX-FAST, and Softcare are trademarks of Nellcor Puritan Bennett LLC, a Covidien company. Masimo, Masimo SET, and LNOP are federally registered trademarks of the Masimo Corporation. Transpac and SafeSet are trademarks of ICU Medical, Inc. Other product and company names mentioned in this book may be trademarks of their respective owners. 284 24 Specifications Symbols These symbols can appear on the monitor and its associated equipment and packaging (depending on options). Symbols Caution, refer to accompanying documents On/Off/Standby Alternating current DC power source Rechargeable battery symbol Battery Eject ECG Sync Pulse Output indicator Connection direction indicator Pressure connector Temperature connector Connection direction indicator NBP connector Uses FAST SpO2 algorithm Masimo SET technology Silence Alarms Alarms Switched Off Connector has special protection against electric shocks and is defibrillator proof SpO2 connector LAN connection indicator for connection to a wired network Nellcor OxiMax compatible Alarms On/Off Identifies year and month of manufacture ECG connector Error LED IntelliVue Instrument Telemetry wireless network Always use separate collection for waste electrical and electronic equipment
(WEEE) 285 24 Specifications Symbols Monitor supports 12-lead ECG Indicates location of the date of manufacture and/or name and address of manufacturer Built-in short range radio interface Built-in wireless network Indicates location of catalog number Main Screen Followed by two alphanumeric characters, indicates ingress protection grade Indicates location of service number Indicates location of serial number SmartKeys Electrical input indicator
(In some cases gas input indicator) Non-ionizing radiation symbol Electrical output indicator
(In some cases gas output indicator) LAN connection indicator for connection to a wired network Start a measurement Stop a measurement Enter the measurement setup menu Zero the invasive pressure transducer Mass in kilogram (kg) Indicates location of batch number Indicates the location of the "use by" date Not made with natural rubber latex Prescription use only Contents of the packaging are not sterile Atmospheric pressure limitations for storage Temperature limitations for storage Humidity limitations for storage 286 Installation Safety Information 24 Specifications WARNING If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in IEC/EN 60601-1, IEC 60601-1-1, UL 60601-1. Consult your service personnel. Earthing The monitor must be earthed during operation. The earthing is for functional purposes and does not provide protection against electric shock. The protection against electric shock in this device is provided by double and/or reinforced insulation. If a three-wire receptacle is not available, consult the hospital electrician. Never use a three-wire to two-wire adapter. Combining equipment Combinations of medical equipment with non-medical equipment must comply with IEC 60601-1-1. Never use a multiple portable socket-outlet or extension cord when combining equipment unless the socket outlet is supplied specifically for use with that equipment. All network cables must be unshielded. Network Cables Connectors The actual placement of boards and configuration of connections for your monitor depends on how your hardware has been configured. See the symbols table in this chapter to see which symbols are used to mark the connections. WARNING Connect only medical devices to the ECG output connector socket. Connecting the ECG sync out to external equipment should only be done by a qualified user. Do not touch the patient when you have contact to the ECG output connector socket. Always connect the ECG sync cable first to the external device and then to the monitor. Wherever possible, pre-install the cable before the patient is brought into the vicinity of the equipment. Monitor Mounting Precautions Mount the monitor using either the Philips Quick Mount or Fix Mount solution or another approved mounting solution. Select the mounting equipment and the mounting position so that no patient, operator or other person can be harmed by a monitor removed intentionally or released accidentally from the mount. When using the Quick Mount, be aware of the danger of accidental activation of the Quick Mount release button when lifting or moving items located under the monitor, such as pole mounts, etc. If in doubt, use the Philips Fix Mount solution to avoid such situations. Refer to the respective IntelliVue Monitor Service Manual, Installation Instructions chapter, for more details. Always ensure that the monitor is positioned so that the AC power plug is easily accessible, to allow disconnection of the monitor from the AC power source. Repositioning a Monitor on the Mounting Arm Attempts to reposition the monitor should only be performed as described in the mounting hardware manufacturers user documentation. If the mounting arm has a locking mechanism, ensure the locking mechanism is unlocked before attempting to reposition the monitor. Never pull on the monitor to tilt, swivel or otherwise reposition it - always hold on to the mounting hardware itself. 287 24 Specifications WARNING Not adhering to these instructions when repositioning the monitor can cause damage to the monitor. In extreme cases, when force is applied to the monitor, it can result in the monitor falling from the mounting arm. If, at any time, the monitor appears to be loose or insecurely mounted, contact your service personnel. Altitude Setting Altitude affects CO2 measurements. The monitor must be configured at installation to the correct altitude. Monitor Safety Specifications The monitor and MMS Extensions comply with the Medical Device Directive 93/42/EEC. In addition, the product complies with:
IEC 60601-1:1988 + A1:1991 + A2:1995 EN60601-1:1990 + A1:1993 + A2:1995 UL 60601-1:2003 CAN/CSA C22.2#601.1-M90 +Suppl. No. 1-94 + Am. 2 IEC 60601-1-1:2000 EN 60601-1-1:2001 IEC 60601-1-2:2001 + A1:2004 EN 60601-1-2:2001 + A1:2006. The possibility of hazards arising from software errors was minimized in compliance with:
ISO 14971:2007 EN60601-1-4:1996 + A1:1999 IEC 60601-1-4:1996 + A1:1999. Classification (according to IEC 60601-1): Class II, Type CF, Continuous Operation. EMC and Radio Regulatory Compliance This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme la norme NMB-
001 du Canada. The MP2 including IntelliVue Instrument Telemetry WMTS (US only)) The MP2 including IntelliVue Instrument Telemetry WMTS complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. 288 24 Specifications The MP2 including IntelliVue Instrument Telemetry ISM (2.4 GHz) FCC and Industry Canada Radio Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radiofrequency interference and void your authority to operate this equipment. The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market. This product is intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA. The MP2 Including the IntelliVue 802.11 Wireless Network Adapter FCC and Industry Canada Radio Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radiofrequency interference and void your authority to operate this equipment. The maximum antenna gain permitted (for devices in the 5250-5350 MHz and 5470-5725 MHz bands) complies with the e.i.r.p. limits as stated in RSS-210. The maximum antenna gain permitted (for devices in the 5725-5825 MHz band) complies with the e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210. The device for the band 5150-5250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION High power radars are allocated as primary users (meaning they have priority) of 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and /or damage to LE-LAN devices. IntelliVue 802.11 Wireless Network Adapter CE Compliance The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 2 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market. This product is intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA. In addition the product complies with: ETSI EN 300 328; ETSI EN 301 893; AS/NZS 4771+A1;
ARIB STD-T66. 289 24 Specifications Radiofrequency Radiation Exposure Information For body worn operation, this equipment has been tested and meets the FCC RF exposure guidelines when used with the accessories supplied or those approved for use with this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. The MP2 and 865244 Remote Control Including the Short Range Radio Interface FCC and Industry Canada Radio Compliance: This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radiofrequency interference and void your authority to operate this equipment. The radio component contained in this device is in compliance with the essential requirements and other relevant provisions of Council Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive) In addition the product complies with: ETSI EN 300 328; AS/NZS 4268; ARIB STD-T66. Class 1 radio equipment. To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given in the Manufacturer's Information section of these Instructions for Use Out-Of-Hospital Transport - Standards Compliance The MP2 patient monitor with measurements and interfaces other than those listed below cannot be used for patient transport outside of the hospital environment. The MP2 patient monitor, with the following measurements and interfaces:
ECG/Respiration, NBP, SpO2, Pressure, Temperature, CO2 (only Mainstream Sensor M2501A) LAN, internal Battery can be used in a transport environment such as a road ambulance, airplane or helicopter. For this purpose the monitor fulfils the following additional mechanical, EMC and environmental requirements:
Shock Tests according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-27 (peak acceleration up to 100g). Random Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-64 (RMS acceleration 5g). Sinusoidal Vibration according to IEC TR 60721-4-7, Class 7M3. Test procedure according to IEC/EN 60068-2-6 (acceleration up to amplitude 2g). Bump Test according to IEC/EN 60068-2-29 (peak acceleration 15 g, 1000 bumps). Free Fall Test according to EN1789 (covers also IEC TR 60721-4-7 and Class 7M3). Test procedure according to EN 60068-2-32 (height 0.75 m). Specification for degrees of protection provided by enclosures according to IEC/EN 60529: IP 32. 290 24 Specifications EN 1789 +A1:2003 Medical vehicles and their equipment - Road ambulances (chapter 6 - Medical Devices). Radiated susceptibility 20 V/m according to EN ISO 9919 (SpO2) and EN ISO 21647 (CO2). Altitude Range from -500 to 3000 m operating and -500 to 4600 m storage and transportation. Extended radiated susceptibility tests The MP2 patient monitor with its out-of-hospital parameter set provides a general immunity level of 20 V/m with only few restrictions. Details are as listed below:
GSM 900: Immunity at 900 MHz (uplink mobile phone), 20 V/m (ECG:10 V/m), duty cycle 1:8. GSM 1800: Immunity at 1800 MHz (uplink mobile phone), 20 V/m, duty cycle 1:8. DECT: Immunity at 1800 MHz (digital cordless phone), 20 V/m, duty cycle 1:24. AM: 1 kHz Immunity from 80 MHz to 1.0 GHz (any radio communication unit, broadcasting and TV transmitter), 20 V/m, modulation factor 80%. (ECG: 20 V/m except 600-950 MHz where it is 10 V/m and Temperature which holds 3 V/m over the full range). CAUTION Temperature measurement accuracy may be compromised in the presence of strong electromagnetic fields (>3V/m) in certain small frequency bands. Magnetic Field emission according to MIL STD 461E, Chapter RE101: Radiated emissions, magnetic field, 30 Hz to 100 kHz. Limit class: Army. Magnetic Field susceptibility: Radiated susceptibility, magnetic field, 50, 60 and 400 Hz, 18 T(15 A/m). Operating ambient temperature testing over the range from 0 to 40C (32 to 100F). Operating ambient humidity testing up to 95 % RH at 40C (100F), non condensing. NOTE There may be additional requirements for transport situations in air, on water or in difficult terrain in certain countries, e.g. EU. Physical Specifications Product MP2 Monitor Maximum Weight 1.2 kg (2.6 lbs) M8023A External Power Supply 0.6 kg (1.3 lbs) 865297 Battery Extension 1.3 kg (2.9 lbs) Comments including battery, with handle and options Size (W x H x D) 199x 146 x 89 mm
(7.8 x 5.7 x 3.5 in) 208x 105 x 135 mm
(8.2 x 4.1 x 5.3 in) 193 x 140 x 132 mm
(7.6 x 5.5 x 5.2in) 291 24 Specifications Environmental Specifications The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges. The monitor is protected against ingress of objects and fluids according to IEC 60529 IP32 (see specifications below). Do not expose the monitor directly to heavy rain. When the monitor and related products have differing environmental specifications, the effective range for the combined products is that range which is common to the specifications for all products. Item Temperature Range Temperature Range with the Wireless IntelliVue Adapter or IntelliVue Instrument Telemetry Wireless Network or when charging the battery Humidity Range Altitude Range Ingress Protection Condition Operating Storage including transportation Operating Range 0 to 40C (32 to 104F)
-20 to 60C (-4 to 140F) 0 to 35C (32 to 95F) Operating Storage including transportation Operating Storage including transportation Monitor External Power Supply (M8023A) Battery Extension (865297) 15% to 95% Relative Humidity (RH) 5% to 95% Relative Humidity (RH)
-500 m to 3000 m (10000 ft)
-500 m to 4600 m (15000 ft)1 IP32 (protected against ingress of water when the water is dripping vertically and the monitor is tilted up to 15and ingress of foreign objects larger than 2.5 mm) IP31(protected against the ingress of solid foreign objects 2.5 mm in diameter or larger, and the ingress of water when the water is dripping vertically) when rested on its rubber feet on a flat, level surface. IP32 when mounted as described in the Service Guide. IP32 (protected against ingress of water when the water is dripping vertically and the monitor is tilted up to 15, not protected against heavy rain.) 1 Sufficient for flight altitudes up to 12,000 m with pressurized cabins 292 24 Specifications Monitor Performance Specifications Performance Specifications Power Specifications Power consumption Operating Voltage Battery Specifications Operating Time (with new, fully charged battery at 25C) Indicators Sounds Charge Time Alarms Off Alarms On/Standby / Error AC Power Battery External Power Audible feedback for user input Prompt tone QRS tone, or SpO2 modulation tone 4 different alarm sounds Display Wave Speeds Trends Resolution Information Alarm signal System alarm delay The system alarm delay is the processing time the system needs for any alarm to be indicated on the monitor, after the measurement has triggered the alarm. Delay for alarm availability on the network This is the time needed after alarm indication on the monitor until the alarm signal is available on the network, to the IntelliVue Information Center or for transmission to other systems. Pause duration Extended alarm pause Sound pressure range Review Alarms Information Capacity
<12 W average
<30 W while battery is loading 36 to 60 V DC floating Basic monitoring configuration: 2.5 hours
(Brightness set to Optimum, ECG/Resp, SpO2 measurements in use, NBP measurement every 15 minutes) When monitor is off: 2 hours When monitor is in use, and connected to the external power supply (M8023A), without MMS extensions: 12 hours approx. red or yellow LED with crossed out alarms symbol red/yellow/light blue (cyan) LED green / red LED green LED yellow (charging)/red blinking (empty) LED green LED 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s with 5% accuracy (guaranteed only for integrated displays) 12 or 16 numerics @ 12 sec, 1 minute, 5 minute resolution. Multiple choices of number of numerics, resolution and duration depending on trend option and application area. For example:
For neonatal, you can choose between 12 and 16 numerics. less than 4 seconds less than 5 seconds 1,2,3 minutes or infinite, depending on configuration 5 or 10 minutes min. 0 dB(A) max. 45-85 dB(A) all alarms / inops, main alarms on/off, alarm silence and time of occurrence 300 items 293 24 Specifications Performance Specifications Real Time Clock Range Accuracy Hold Time Buffered Memory Hold Time Contents from: January 1, 1997, 00:00 to: December 31, 2080, 23:59
<4 seconds per day (typically) infinite if powered by external power supply; otherwise at least 48 hours if powered by external power supply: infinite without power: at least 48 hours Active settings, trends, patient data, realtime reports, review alarms M8023A External Power Supply Performance Specifications Power Specifications Power consumption Indicators Display Specifications Integrated QVGA Display Line Voltage Current Frequency AC Power Sweep Speeds Resolution Refresh frequency Useful screen Pixel size
<12 W average
<30 W peak 100 to 240 V ~
1.3 to 0.7 A 50/60 Hz ~
green LED 6.25, 12.5, 25 and 50 mm/s 320 x 240 60 Hz 72 x 54 mm (2.8 x 2.1 in) 0.22 x 0.22 mm Monitor Interface Specifications Monitor Interface Specifications Measurement Link
(MSL) Connectors Power Power Sync. LAN signals Serial signals Local signals Female ODU (Proprietary) 30 V to 60 V input RS-422 compliant input 78.125kHz (typical) IEEE 802.3 10-Base-T compliant RS-422 compliant Provided for connecting measurement extensions 294 24 Specifications Monitor Interface Specifications ECG Sync Pulse Cable detection Output1 Marker In Wave Output Connector Output levels Isolation Pulse Width Delay from R-wave peak to start of pulse Minimum required R-wave amplitude Type Technology Frequency Band IntelliVue 802.11 Bedside Adapter
(Wireless Network Adapter) Modulation Technique Effective radiated power Type Technology Frequency Band Modulation Technique Effective radiated power Short Range Radio Interface2 Yes No No Binder Series 709/719 Output low <0.8 V @ I = -4 mA Output high >2.4 V @ I = 4 mA None 100 +/-10 ms (high) 20 ms maximum per AAMI EC13 0.5 V Internal wireless adapter IEEE 802.11a/b/g USA: 2.400 - 2.483GHz, 5.15 - 5.35GHz, 5.725 - 5.825GHz Europe: 2.400 - 2.483GHz, 5.15 - 5.35GHz, 5.47 - 5.725GHz Japan: 2.400 - 2.483GHz, 2.471 - 2.498GHz, 4.900 - 5.091GHz, 5.150 -
5.250GHz, 5.25 - 5.35GHz, 5.470 - 5.725GHz China: 2.400 - 2.483GHz, 5.725 -5.85GHz 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK,QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK,QPSK, 16-QAM, 64-QAM) max 18 dBm Internal SRR interface IEEE 802.15.4 2.4 GHz ISM (2.400 - 2.483 GHz) DSSS (O -QPSK) max. 0 dBm (1 mW) IntelliVue Instrument Telemetry Wireless Network (USA only) Internal WMTS Adapter Technology Frequency Band IntelliVue Instrument Telemetry Wireless Network Internal ISM Adapter Technology Frequency Band compatible with Philips IntelliVue Telemetry System (ITS), cellular infrastructure WMTS, 1395-1400 MHz and 1427-1432 MHz compatible with Philips IntelliVue Telemetry System (ITS), cellular infrastructure 2.4 GHz ISM 1 See Connectors on page 287 for safety-related information) 2 The short range radio interface is compatible with the IntelliVue Cableless Measurements and the following devices:
TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver and MX40 Patient Wearable Monitor. 295 24 Specifications M8023A External Power Supply Interface Specifications Measurement Link
(MSL) 865297 Battery Extension Interface Specifications Measurement Link
(MSL) Measurement Link
(MSL) Connectors Power Power Sync. LAN signals Serial signals Local signals Connectors Power Power Sync. LAN signals Serial signals Local signals Connectors Power Power Sync. LAN signals Serial signals Local signals Male ODU (Proprietary) 48 V output RS-422 compliant output 78.125 kHz (typical) IEEE 802.3 10-Base-T compliant RS-422 compliant output 78.125 kHz (typical) Not connected Male ODU (Proprietary) 36 -38 V output RS-422 compliant output 78.125 kHz (typical) IEEE 802.3 10-Base-T compliant RS-422 compliant Not connected Female ODU (Proprietary) 30-60 V input RS-422 compliant input 78.125 kHz (typical) IEEE 802.3 10-Base-T compliant RS-422 compliant Not connected 865297 Battery Extension Specifications 865297 Battery Extension Battery Specifications Battery Type Indicators M4605A green power LED and green-yellow-red battery status LED M4607A Battery Specifications One battery is required for battery operation of the monitor. The battery lifetime is 3 years from manufacturing date or 500 charge/discharge cycles. M4607A Battery Specifications Physical Specifications W x D x H Weight Performance Specifications Nominal Voltage Rated Capacity at discharge C/5 Environmental Specifications 296 66 mm (2.36 in) x 80 mm (3.15 in) x 20 mm (0.79 in) 160 g 5%
10.8 Volt 1000 mAh (typical) 24 Specifications M4607A Battery Specifications Temperature Range Humidity Range Battery Type Safety Electromagnetic Compatibility (EMC) Communication Standard Discharge 0 to 60C (32 to 122F) Charge 0 to 60C (32 to 122F) Storage and Transportation: -20 to 65C (-4 to 140F) Operating: 15% to 95% Relative Humidity (RH) Storage and Transportation: 5% to 95% Relative Humidity (RH) Lithium Ion Manganese, 10.8 V, 1000 mAh complies with UL 2054 complies with the requirements for FCC Type B computing Device, and EN 61000-4-2 and EN 61000-3-2 complies with the SMBus specification v1.1 M4605A Battery Specifications The battery lifetime is 3 years from manufacturing date or 500 charge/discharge cycles. M4605A Battery Specifications Physical Specifications W x D x H Weight Performance Specifications Nominal Voltage Rated Capacity at discharge C/5 Continuous Discharge Capability Environmental Specifications Temperature Range Humidity Range Battery Type Safety Electromagnetic Compatibility (EMC) Communication Standard 149 x 89 x 19.8 mm (5.866 x 3.504 x 0.78 in) 490 g (1.08 lb) per battery 10.8 Volt 6000 mAh 6.5 A Discharge 0 to 50C (32 to 122F) Charge 0 to 50C (32 to 122F) Storage and Transportation: -20 to 65C (-4 to 140F) Operating: 15% to 95% Relative Humidity (RH) Storage and Transportation: 5 % to 95 % Relative Humidity (RH) Smart Battery 10.8 V, 6000 mAh, Lithium Ion complies with UL 2054 complies with the requirements for FCC Type B computing Device, and EN 61000-4-2 and EN 61000-3-2 complies with the SMBus specification v 1.1 297 24 Specifications Measurement Specifications See the Default Settings Appendix for a list of the settings the monitor is initially shipped with. ECG/Arrhythmia/ST/QT Complies with:
AAMI EC11/EC13:1991/2002 IEC 60601-2-25:1993 + A1:1999/EN60601-2-25:1995 + A1:1999 IEC 60601-2- 27:2005/EN60601-2-27:2006 IEC 60601-2-51:2003/EN 60601-2-51:2003 ECG/Arrhythmia/ST Performance Specifications Cardiotach Range PVC Rate ST Numeric QT Numeric QTc Numeric QTc Numeric QT-HR Numeric Sinus and SV Rhythm Ranges Accuracy Resolution Sensitivity Range Resolution Range Accuracy Resolution Range Accuracy Resolution Range Resolution Range Resolution Range - adult Range - pediatric and neonatal Brady Normal Tachy Adult/pedi: 15 to 300 bpm Neo range: 15 to 350 bpm Note: for rates equal to or less than 15 bpm, the displayed heart rate is 0. 1% of range 1 bpm 200 Vpeak 0 to 300 bpm 1 bpm
-20 to +20 mm 0.5 mm or 15%, whichever is greater 0.1 mm 200 to 800 ms 30 ms 8 ms 200 to 800 ms 1 ms
-600 to +600 ms 1 ms 15 to 150 bpm 15 to 180 bpm Adult: 15 to 59 bpm Pedi: 15 to 79 bpm Neo: 15 to 89 bpm Adult: 60 to 100 bpm Pedi: 80 to 160 bpm Neo: 90 to 180 bpm Adult: >100 bpm Pedi: >160 bpm Neo: >180 bpm 298 24 Specifications ECG/Arrhythmia/ST Performance Specifications Bandwidth Diagnostic Mode Extended Monitoring Mode Monitoring Mode Bandwidth when the ECG is transmitted from a telemetry device via short range radio Filter Mode Diagnostic Mode Extended Monitoring Mode Monitoring Mode Filter Mode Differential Input Impedance Common Mode Rejection Ratio Electrode Offset Potential Tolerance Auxiliary Current
(Leads off Detection) Input Signal Range Adult/neo/pedi: 0.05 to 150 Hz Adult/neo/pedi: 0.5 to 150 Hz Adult: 0.5 to 40 Hz Neo/pedi: 0.5 to 55 Hz Adult/neo/pedi: 0.5 to 20 Hz Adult/neo/pedi: 0.05 to 40 Hz Adult/neo/pedi: 0.5 to 40 Hz Adult: 0.5 to 40 Hz Neo/pedi: 0.5 to 40 Hz Adult/neo/pedi: 0.5 to 20 Hz
>2 M RA-LL leads (Resp)
>5 M at all other leads (at 10 Hz including patient cable) Diagnostic mode: >86 dB (with a 51 k/47 nF imbalance). Filter mode: >106 dB (with a 51 k/47 nF imbalance). 500 mV Active electrode: <100 nA Reference electrode: <900 nA 5 mV ECG/Arrhythmia/ST/QT Alarm Specifications HR Extreme Tachy Extreme Brady Run PVCs PVCs Rate Vent Tach HR Vent Tach Run Vent Rhythm Run SVT HR SVT Run ST High ST Low STE Limit QTc High QTc High Range Adjustment 15 to 300 bpm maximum delay: 10 seconds according to AAMI EC 13-1992 standard Difference to high limit 0 to 50 bpm Clamping at 150 to 300 bpm Difference to low limit 0 to 50 bpm Clamping at 15 to 100 bpm None, fixed setting 2 PVCs 1 to 99 PVCs/minute 20 to 300 bpm 3 to 99 PVCs/minute 3 to 99 PVCs/minute 120 to 300 bpm 3 to 99 SV beats
-19.8 to +20 mm
-20 to +19.8 mm
-20 to +20 mm 200 ms to 800 ms 30 ms to 200 ms Adult:1 bpm steps (15 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi/Neo:1 bpm steps (15 to 50 bpm) 5 bpm steps (50 to 300 bpm) 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps Not adjustable by user 1 PVC 5 bpm 1 PVC 1 PVC 5 bpm 1 SV beat 0.2 mm 0.2 mm 0.2 mm 10 ms steps 10 ms steps 299 24 Specifications ECG/Arrhythmia/ST Supplemental Information as required by AAMI EC11/13, IEC 60601-2-27 Respiration Excitation Waveform Noise Suppression Time to Alarm for Tachycardia Vent Tachycardia 1 mVpp,206 bpm Vent Tachycardia 2 mVpp,195 bpm Tall T-Wave Rejection Capability Heart Rate Averaging Method Response Time of Heart Rate Meter to Change in Heart Rate Heart Rate Meter Accuracy and Response to Irregular Rhythm Ventricular bigeminy: 80 bpm Sinusoidal signal, 260 A, 40.5 kHz RL drive gain 44 dB max., max. voltage 1.8 Vrms Gain 0.5, Range 6.5 to 8.4 seconds, Average 7.2 seconds Gain 1.0 Range 6.1 to 6.9 seconds, Average 6.5 seconds Gain 2.0, Range 5.9 to 6.7 seconds, Average 6.3 seconds Gain 0.5, Range 5.4 to 6.2 seconds, Average 5.8 seconds Gain 1.0, Range 5.7 to 6.5 seconds, Average 6.1 seconds Gain 2.0, Range 5.3 to 6.1 seconds, Average 5.7 seconds Exceeds ANSI/AAMI EC 13 Sect. 3.1.2.1(c) minimum recommended 1.2 mV T-Wave amplitude Three different methods are used:
Normally, heart rate is computed by averaging the 12 most recent R-R intervals. For runs of PVCs, up to 8 R-R intervals are averaged to compute the HR. If each of 3 consecutive R-R intervals is greater than 1200 ms
(that is, rate less than 50 bpm), then the 4 most recent R-R intervals are averaged to compute the HR. HR change from 80 to 120 bpm:
Range: [6.4 to 7.2 seconds] Average: 6.8 seconds HR change from 80 to 40 bpm:
Range: [5.6 to 6.4 sec] Average: 6.0 seconds Slow alternating ventricular bigeminy: 60 bpm Rapid alternating ventricular bigeminy: 120 bpm Bidirectional systoles: 90 bpm Methods A and D were used to establish overall system error and frequency response. Rejection of pacemaker pulses with amplitudes from 2 mV to 700 mV and widths from 0.1 ms to 2.0 ms (Method A) 2.2 V/s RTI (Paced Mode) 2.2 V/s RTI Adult/pedi: 0 to 120 rpm Neo: 0 to 170 rpm at 0 to 120 rpm 1 rpm at 120 to 170 rpm 2 rpm 1 rpm 0.3 to 2.5 Hz (-6 dB) Less than 25 m (rms) referred to the input Accuracy of Input Signal Reproduction Pacemaker Pulse Rejection Performance Pacemaker Pulse Rejection of fast ECG signals Minimum input slew rate Respiration Respiration Performance Specifications Respiration Rate Range Accuracy Resolution Bandwidth Noise 300 24 Specifications Respiration Alarm Specifications High Low Range Adjustment Delay Adult/pedi: 10 to 100 rpm Neo: 30 to 150 rpm Adult/pedi: 0 to 95 rpm Neo: 0 to 145 rpm
< 20 rpm: 1 rpm steps 20 rpm: 5 rpm steps
< 20 rpm: 1 rpm steps 20 rpm: 5 rpm steps max. 14 seconds for limits from 0 to 20 rpm:
max. 4 seconds for limits above 20 rpm: max. 14 seconds Apnea Alarm 5 second steps Respiration from the CL Respiration Pod 10 to 40 seconds For the general measurement specifications, refer to the IntelliVue Cableless Measurements Instructions for Use. The alarm specifications for alarms generated by the CL Respiration pod and indicated by the monitor are listed in the table below. cmResp Alarm Specifications Respiration Rate Range 5 to 60 rpm Bradypnea Pulse Tachycardia Bradycardia SpO2 Difference to high limit 0 to 20 rpm Clamping at 5 to 50 rpm 30 to 220 bpm Difference to high limit 0 to 50 bpm Clamping at 150 to 220 bpm Difference to low limit 0 to 50 bpm Clamping at 30 to 100 bpm Adjustment
<20 rpm: 1 rpm steps
>20 rpm: 5 rpm steps 1 rpm steps
<20 rpm: 1 rpm steps
>20 rpm: 5 rpm steps 30 to 40 bpm: 1 bpm steps 40 to 220 bpm: 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps Complies with ISO 9919:2005 / EN ISO 9919:2009 (except alarm system; alarm system complies with IEC 60601-2-49:2001). Measurement Validation The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-
oximeter measurements. 301 24 Specifications Philips FAST SpO2 Performance Specifications Range Accuracy Philips FAST SpO2 Performance Specifications SpO2 The specified accuracy is the root-mean-
square (RMS) difference between the measured values and the reference values 0 to 100%
Philips Reusable Sensors:
M1191A, M1191AL, M1191B, M1191BL, M1192A, = 2% (70% to 100%) M1193A, M1194A, M1195A, M1196A, M1196S = 3% (70% to 100%) M1191T, M1192T, M1193T (Adult), M1196T = 3% (70% to 100%) M1193T (Neonate) = 4% (70% to 100%) Philips Disposable Sensors with M1943A(L):
M1132A, M1133A (adult/infant), M1134A (adult/infant) = 2%
M1901B, M1902B, M1903B, M1904B, M1131A, M1133A (neonate), M1134A (neonate) =
3% (70% to 100%) NellcorPB Sensors with M1943A(L):
MAX-A, MAX-AL, MAX-P, MAX-I, MAX-N, D-25, D-20, I-20, N-25, OxiCliq A, P, I, N
= 3% (70% to 100%) Masimo Reusable Sensors with LNOP MP12 or LNC MP10:
LNOP DC-I, LNOP DC-IP, LNOP YI (adult/pedi/infant), LNCS DC-1, LNCS DC-IP, LNCS YI (adult/pedi/infant) = 2% (70% to 100%) LNOP YI (neonate), LNCS YI (neonate) = 3% (70% to 100%) LNOP TC-I, LNCS TC-I: 3.5% (70% to 100%) Masimo Disposable Sensors with LNOP MP12 or LNC MP10:
LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNOP Inf-L, LNOP Neo-L (adult), LNCS Adtx, LNCS Adtx-3, LNCS Pdtx, LNCS Pdtx-3, LNCS Inf, LNCS Inf-3, LNCS Neo (adult), LNCS Neo-3 (adult) = 2% (70% to 100%) LNOP Neo-L (neonate), LNOP NeoPt-L, LNCS Neo (neonate), LNCS Neo-3 (neonate), LNCS NeoPt, LNCS NeoPt-3 = 3% (70% to 100%) 1%
30 to 300 bpm 2% or 1 bpm, whichever is greater 1 bpm Typical: 2 seconds, Maximum: 30 seconds. Maximum with NBP INOP suppression on: 60 seconds. Wavelength range: 500 to 1000 nm Emitted Light Energy: 15 mW Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed) 70% to 100%
Pulse Resolution Range Accuracy Resolution Numeric Update Rate Sensors Pulse Oximeter Calibration Range 302 Nellcor OxiMax Performance Specifications 24 Specifications Range Accuracy Pulse Oximetry Performance Specifications SpO2 The specified accuracy is the root-
mean-square (RMS) difference between the measured values and the reference values Low perfusion accuracy5 Resolution Range Accuracy Low perfusion accuracy5 Resolution Pulse Numeric update rate Sensors 1 to 100%
M1901B1, M1902B, M1903B, M1904B, MAXA, MAXAL, MAXP, MAXI, MAXN1, MAXFAST: adult/infant = 2% (70% to 100%) M1902B, M1903B, M1904B, MAXA, MAXAL, MAXP, MAXI, MAXN1, MAXFAST: adult
=3% (60% to 80%) MAXN1:neonate = 2% (70% to 100%) Oxicliq A, Oxicliq P, Oxicliq L, Oxicliq N4: adult/infant =2.5% (70% to 100%) Oxicliq N4:neonate = 3.5% (70% to 100%) MAXR2, D-YSE, D-YSPD: adult/infant = 3.5% (70% to 100%) SoftCare SC-A (adult/infant), SoftCare SC-PR-I3 (neonate), SoftCare SCNEO-I3: (neonate) =
2% (70% to 100%) DS-100A-I, D-YS, Oxiband OXI-A/N, Oxiband OXI-P/I:adult/infant = 3% (70% to 100%) D-YS4, Oxiband OXI-A/N4: neonate = 4% (70% to 100%) 2% (70 - 100%) 1%
25 to 300 bpm
+/- 3 bpm (25 to 250 bpm)
+/- 3 bpm (25 to 250 bpm) 1 bpm typical 1 second, max 60 seconds Wavelength range: 500 to 1000 nm Emitted Light Energy: 15 mW Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed) 1. M1901B/MAXN:
Clinical functionality has been demonstrated on a population of hospitalized neonate patients. The observed SpO2 accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4100 grams, and 63 observations made spanning a range of 85 to 99% SaO2 while monitored with Nellcor OxiMax N-595 pulse oximeters. 2. The accuracy specification has been determined between saturations of 80%100%. 3. SoftCare SC-PR-I, SCNEO-I:
Clinical functionality has been demonstrated on a population of hospitalized neonate and infant patients. The observed SpO2 accuracy was 3.0% in a study of 57 patients with ages of 24 to 40 weeks, weight from 710 to 5,000 grams, and 185 observations made spanning a range of 63 to 100% SaO2 while monitored with Nellcor OxiMax N-595 pulse oximeters. 4. Neonatal accuracy: When sensors are used on neonatal subjects as recommended, the specified accuracy range is increased by 1 digit, as compared to adult usage, to account for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. For example, Oxicliq N accuracy on neonates is 3.5 digits, rather than 2.5. 5. Specification applies to the performance of the device. Reading accuracy in the presence of low perfusion (detected IR pulse modulation amplitude 0.03% - 1.5%) was validated using signals supplied by a patient simulator. SpO2 and pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to the known true saturation and pulse rate of the input signals. 303 24 Specifications Nellcor Patents: The monitor with Nellcor OxiMax technology are covered by one or more of the following US Patents and foreign equivalents:
5,485,847; 5,676,141; 5,743,263; 6,035,223; 6,226,539, 6,411,833; 6,463,310; 6,591,123; 6,708,049;
7,016,715; 7,039,538; 7,120,479; 7,120,480; 7,142,142; 7,162,288; 7,190,985; 7,194,293; 7,209,774;
7,212,847; 7,400,919. Purchase of the instrument with Nellcor OxiMax technology confers no express or implied license under any Covidien patent to use that instrument with any sensor not manufactured or licensed by Covidien. SpO2 Alarm Specifications SpO2 Alarm Specifications SpO2 Desat Pulse Tachycardia Bradycardia Range Adult: 50 to 100%
Pedi/Neo: 30 to 100%
Adult: 50% to Low alarm limit Pedi/Neo: 30% to Low alarm limit 30 to 300 bpm Difference to high limit 0 to 50 bpm Clamping at 150 to 300 bpm Difference to low limit 0 to 50 bpm Clamping at 30 to 100 bpm Adjustment 1% steps 1% steps Adult:
1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi/Neo:
1 bpm steps (30 to 50 bpm) 5 bpm steps (50 to 300 bpm) 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps SpO2 Alarm Specifications (cont.) SpO2 high and low limit alarms Desat Pulse Tachycardia Bradycardia Standard Delay 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay1 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay 10 seconds + system alarm delay 10 seconds + system alarm delay 10 seconds + system alarm delay Smart Alarm Delay (alternative to standard alarm delay) Short Mode 10 to 25 seconds +
system alarm delay Medium mode 10 to 50 seconds
+system alarm delay Long Mode 10 to 100 seconds +
system alarm delay not supported 1. Refer to Monitor Performance Specifications on page 293 for system alarm delay specification. 304 24 Specifications SpO2 Smart Alarm Delay - Detailed Specifications Deviation from violated alarm limit Resulting alarm delay according to selected mode Short 25 seconds
(maximum delay) 12 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds Medium 50 seconds
(maximum delay) 25 seconds 16 seconds 12 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds 10 seconds Long 100 seconds
(maximum delay) 50 seconds 33 seconds 25 seconds 20 seconds 16 seconds 14 seconds 12 seconds 11 seconds 10 seconds 1%
2%
3%
4%
5%
6%
7%
8%
9%
>9%
NBP Complies with IEC 60601-2-30:1999/EN60601-2-30:2000. NBP Performance Specifications Measurement Ranges Systolic Diastolic Mean Pulse Rate Accuracy Pulse Rate Measurement Accuracy Pulse Rate Range Adult: 30 to 270 mmHg (4 to 36 kPa) Pedi: 30 to 180 mmHg (4 to 24 kPa) Neo: 30 to 130 mmHg (4 to 17 kPa) Adult: 10 to 245 mmHg (1.5 to 32 kPa) Pedi: 10 to 150 mmHg (1.5 to 20 kPa) Neo: 10 to 100 mmHg (1.5 to 13 kPa) Adult: 20 to 255 mmHg (2.5 to 34 kPa) Pedi: 20 to 160 mmHg (2.5 to 21 kPa) Neo: 20 to 120 mmHg (2.5 to 16 kPa) Adult: 40 to 300 bpm Pedi: 40 to 300 bpm Neo: 40 to 300 bpm Max. Std. Deviation: 8 mmHg (1.1 kPa) Max. Mean Error: 5 mmHg (0.7 kPa) 40 to 100 bpm: 5 bpm 101 to 200 bpm: 5% of reading 201 to 300 bpm: 10% of reading
(average over NBP measurement cycle) 40 to 300 bpm 305 24 Specifications NBP Performance Specifications Measurement Time Cuff Inflation Time Initial Cuff Inflation Pressure Maximum Cuff Pressure Auto Mode Repetition Times STAT Mode Cycle Time Venipuncture Mode Inflation Inflation Pressure Automatic deflation after Adult Pediatric Neonatal Adult/pediatric Neonatal Typical at HR >60 bpm Auto/manual/sequence:
Adult: 30 seconds Neonatal: 25 seconds Stat: 20 seconds Maximum time:
Adult/pedi: 180 seconds Neo: 90 seconds Typical for normal adult cuff: Less than 10 seconds Typical for neonatal cuff: Less than 2 seconds Adult: 165 15 mmHg Pedi: 130 15 mmHg Neo: 100 15 mmHg Adult/Pedi: 300 mmHg Neo: 150 mmHg 1 min, 2 min, 2.5 min, 3 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1h, 2h, 4h, 8h, 12h, 24h 5 minutes 20 to 120 mmHg (3 to 16 kPa) 20 to 80 mmHg (3 to 11 kPa) 20 to 50 mmHg (3 to 7 kPa) 170 seconds 85 seconds Measurement Validation: Clinical investigation according to ISO 81060-2:2013 with the auscultatory reference method:
the 5th Korotkoff sound (K5) was used in adult / adolescent subjects and the 4th Korotkoff sound (K4) was used in pediatric subjects to determine the diastolic reference pressures. the approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures. Clinical investigation according to ISO 81060-2:2013 with the intra-arterial reference method:
the radial artery was used for the intra-arterial reference measurement. the MAP values displayed by the reference invasive blood pressure monitor were used as MAP reference values. blood pressure recordings with any dysrhythmias were excluded. 306 24 Specifications Adjustment 10 to 30 mmHg: 2 mmHg (0.5 kPa)
>30 mmHg: 5 mmHg (1 kPa) not user adjustable NBP Alarm Specifications Systolic Diastolic Mean Range Adult: 30 to 270 mmHg (4 to 36 kPa) Pedi: 30 to 180 mmHg (4 to 24 kPa) Neo: 30 to 130 mmHg (4 to 17 kPa) Adult: 10 to 245 mmHg (1.5 to 32 kPa) Pedi: 10 to 150 mmHg (1.5 to 20 kPa) Neo: 10 to 100 mmHg (1.5 to 13 kPa) Adult: 20 to 255 mmHg (2.5 to 34 kPa) Pedi: 20 to 160 mmHg (2.5 to 21 kPa) Neo: 20 to 120 mmHg (2.5 to 16 kPa) NBP Overpressure Settings Adult Pediatric Neonate Invasive Pressure and Pulse
>300 mmHg (40 kPa) >2 sec
>300 mmHg (40 kPa) >2 sec
>150 mmHg (20 kPa) >2 sec Complies with IEC 60601-2-34:2000/EN60601-2-34:2000. Invasive Pressure Performance Specifications Measurement Range Pulse Rate Range Accuracy Resolution Input Sensitivity Transducer Frequency Response Zero Adjustment Gain Accuracy Range Accuracy Drift Accuracy Drift Non linearity and Hysteresis
(including transducer) Overall Accuracy Volume displacement of CPJ840J6
-40 to 360 mmHg 25 to 350 bpm 1% Full Range 1 bpm Sensitivity: 5 V/V/mmHg (37.5 V/V/kPa) Adjustment range: 10%
Load Impedance: 200 to 2000 (resistive) Output Impedance: 3000 (resistive) dc to 12 Hz or 40 Hz 200 mmHg (26 kPa) 1 mmHg (0.1 kPa) Less than 0.1 mmHg/C (0.013 kPa/C) 1%
Less than 0.05%/C Error of 0.4 %FS (@CAL 200 mmHg) 4% of reading or 4 mmHg (0.5 kPa), whichever is greater 0.1 mm3 /100 mmHg 307 24 Specifications Invasive Pressure Alarm Specifications Invasive Pressure Alarm Specifications Pressure Range
-40 to 360 mmHg
(-5.0 to 48 kPa) Extreme High Extreme Low Pulse Difference to high limit 0 to 25 mmHg Clamping at -40 to 360 mmHg Difference to low limit 0 to 25 mmHg Clamping at -40 to 360 mmHg 25 to 300 bpm Tachycardia Bradycardia Temp Difference to high limit 0 to 50 bpm Clamping at 150 to 300 bpm Difference to low limit 0 to 50 bpm Clamping at 25 to 100 bpm Adjustment Delay
-40 to 50 mmHg 2 mmHg (0.5 kPa)
>50 mmHg 5 mmHg (1 kPa) 5 mmHg steps (0.5 kPa) 5 mmHg steps (1.0 kPa) 5 mmHg steps (0.5 kPa) 5 mmHg steps (1.0 kPa) Adult:
1 bpm steps (25 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi/Neo:
1 bpm steps (25 to 50 bpm) 5 bpm steps (50 to 300 bpm) 5 bpm steps 5 bpm steps 5 bpm steps 5 bpm steps max. 12 seconds max. 14 seconds max. 14 seconds Complies with EN 12470-4:2000. Specified without transducer. Temp Performance Specifications Temp Range Resolution Accuracy Average Time Constant
-1 to 45C (30 to 113F) 0.1C (0.2F) 0.1C (0.2F) Less than 10 seconds Temp Alarm Specifications Range Temp High/Low Alarms
-1 to 45C (30 to 113F) Adjustment
-1 to 30C (30 to 86F), 0.5C (1.0F) steps 30 to 45C (86 to 113F), 0.1C (0.2F) steps 308 CO2 The CO2 measurement in the monitor, M3014A and M3015A complies with EN ISO 21647:2004 +
Cor.1:2005 (except alarm system; alarm system complies with IEC 60601-2-49:2001). 24 Specifications M3015A Microstream CO2 M3015A Microstream CO2 Performance Specifications CO2 Range Accuracy 0 to 150 mmHg (0 to 20 kPa), or 20% CO2, whichever is lower Up to 5 minutes during warmup: 4 mmHg or 12%, whichever is greater After 5 minutes warmup:
0 to 40 mmHg (0 to 5.3 kPa):2.2 mmHg (0.3 kPa) Above 40 mmHg (5.3 kPa):(5.5% + (0.08%/mmHg above 40 mmHg)) of reading These specifications are valid for 21% O2 and N2 balance, up to 35C ambient temperature, up to 60 rpm in adult mode and 100 rpm in neonatal mode. Outside of these conditions the accuracy reaches at a minimum 4 mmHg or 12% of the reading, whichever is greater. Numeric: 1.0 mmHg (0.1 kPa) Wave: 0.1 mmHg (0.01 kPa) Included in Accuracy specifications 0 to 150 rpm 0 to 40 rpm: 1 rpm 41 to 70 rpm: 2 rpm 71 to 100 rpm: 3 rpm
>100 rpm: 5% of reading 1 to 10 1 5 minutes for full accuracy specification 190 ms for neonatal mode
(measured with FilterLine H for neonatal) 240 ms for adult mode
(measured with FilterLine H for adult) 50 + 15/-7.5 ml/minute Maximum:
3 seconds (2m sample lines) 6 seconds (4m sample lines) Acoustic noise: <45 dBA The total system response time is the sum of the delay time and the rise time. Resolution Stability Range Accuracy Range Resolution AwRR IPI Warm-up Time Rise Time Sample Flow Rate Gas Sampling Delay Time Sound Pressure Total System Response Time Microstream CO2 Humidity Correction Factor Either BTPS or ATPD can be selected as the humidity correction factor for the Microstream CO2 readings. The formula for the correction calculation is:
where:
PBTPS = partial pressure at body temperature and pressure, saturated 309 24 Specifications PATPD = partial pressure at ambient temperature and pressure, dry M3014A Mainstream CO2 M3014A Mainstream CO2 Performance Specifications CO2 Range Accuracy 0 to 150 mmHg (0 to 20.0 kPa) after 2 minutes warmup:
For values between 0 and 40 mmHg: 2.0 mmHg (0.29 kPa) For values from 41 to 70 mmHg: 5% of reading For values from 71 to 100 mmHg: 8% of reading The specifications are valid for standard gas mixtures, balance air, fully hydrated at 35C, Pabs =
760 mmHg, flow rate = 2 l/min. Numeric: 1.0 mmHg (0.1 kPa) Wave: 0.1 mmHg (0.01 kPa) 0.8 mmHg over four hours Accuracy specification will be maintained over a 120 hour period 2 to 150 rpm 1 rpm 2 minutes with CO2 transducer attached for full accuracy specification Less than 60 ms (with adult or infant reusable or disposable adapter) M3014A Sidestream CO2 Performance Specifications CO2 Range Accuracy 0 to 150 mmHg (0 to 20.0 kPa) after 2 minutes warmup:
For values between 0 and 40 mmHg: 2.0 mmHg (0.29 kPa) For values from 41 to 70 mmHg: 5% of reading For values from 71 to 100 mmHg: 8% of reading For values from 101 to 150 mmHg: 10% of reading At respiration rates above 80 rpm, all ranges are 12% of actual. The specifications are valid for gas mixtures of CO2, balance N2, dry gas at 760 mmHg within specified operating temperature range. Numeric: 1.0 mmHg (0.1 kPa) Wave: 0.1 mmHg (0.01 kPa) 0.8 mmHg over four hours Accuracy specification will be maintained over a 120 hour period 2 to 150 rpm 1 rpm 2 minutes with CO2 sensor attached for full accuracy specification 50 10 ml/minute 3 seconds 0 to 40C (32 to 100F) Resolution Stability:
Short term drift Long term drift Range Accuracy awRR Warm-up Time Response Time M3014A Sidestream CO2 Resolution Stability:
Short term drift Long term drift Range Accuracy awRR Warm-up Time Sample Flow Rate Total System Response Time Operating Temperature 310 M8102A/M3014A Mainstream and Sidestream CO2 Humidity Correction Factor Either BTPS or ATPD can be selected as the humidity correction factor for the CO2 readings. The formula for the correction calculation is:
24 Specifications Where p = partial pressure, Pabs = absolute pressure, and PH2O = 42 mmHg @35C and 100% RH. CO2 Alarm Specifications Range 20 to 95 mmHg (2 to 13 kPa) 10 to 90 mmHg (1 to 12 kPa) 2 to 20 mmHg
(0.3 to 3.0 kPa) Adult/pedi: 10 to 100 rpm Neo: 30 to 150 rpm Adult/pedi: 0 to 95 rpm Neo: 0 to 145 rpm Adjustment 1 mmHg (0.1 kPa) Delay M8102A/M3014A: less than 14 seconds M3015A: less than 21 seconds. steps of 1 mmHg (0.1 kPa) M8102A/M3014A: less than 14 seconds
<20 rpm: 1 rpm steps 20 rpm:5 rpm steps M3015A: less than 21 seconds. M8102A/M3014A/M3016A: less than 14 seconds M3015A: less than 21 seconds. M3015A:
settings 20 rpm: less than 8 seconds
>20 rpm: less than 21 seconds M8102A/M3014A settings 20 rpm: less than 4 seconds
>20 rpm: less than 14 seconds Maximum 14 seconds after displayed value goes below the low alarm limit setting. set apnea delay time + 4 seconds (M8102A/M3014A) or 8 seconds (M3015A with 2 m sample lines) or 11 seconds (M3015A with 4 m sample lines). Alarm etCO2 High etCO2 Low imCO2 High awRR High awRR Low IPI Low
(M3015A/B only) Apnea delay Adult/pedi: 2 to 9 steps of 1 10 to 40 seconds 5 second steps Interfering Gas and Vapor Effects On CO2 Measurement Values The specified deviations for M8102A/M3014A are valid when the appropriate corrections are switched on and set correctly. Gas or Vapor Gas Level
(% volume fraction) Nitrous Oxide Halothane Enflurane Isoflurane Sevoflurane Xenon Helium Metered dose inhaler propellants 60%
4%
5%
5%
5%
80%
50%
-
M8102A/M3014A M3015A Additional deviation due to gas interference, measured at 0 - 40 mmHg CO2 1 mmHg 5%
5%
2 mmHg 5%
2 mmHg 2 mmHg 5%
5%
2 mmHg 5%
-5 mmHg 1 mmHg 5%
not specified for use 311 24 Specifications Gas or Vapor Desflurane Ethanol Isopropanol Acetone Methane Gas Level
(% volume fraction) 15%
0.1%
0.1%
0.1%
1.0%
M8102A/M3014A M3015A Additional deviation due to gas interference, measured at 0 - 40 mmHg CO2
+5 mmHg 5%
5%
1 mmHg 5%
1 mmHg 1 mmHg 5%
5%
1 mmHg Safety and Performance Tests You must observe any national regulations on the qualification of the testing personnel and suitable measuring and testing facilities. See the maintenance section for a list of required tests. Safety and performance tests, and what to do if the instrument does not meet these specifications, are described in the Service Guide. Electromagnetic Compatibility (EMC) Specifications Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Portable and mobile radiofrequency (RF) communications equipment can affect medical electrical equipment. Accessories Compliant with EMC Standards All accessories listed in the accessories section comply, in combination with the monitor, with the requirements of IEC 60601-1-2:2001 + A1:2004. WARNING Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions The monitor is suitable for use in the electromagnetic environment specified in the table below. You must ensure that it is used in such an environment. Emissions test Radiofrequency (RF) emissions Group 1 Compliance RF emissions CISPR 11 Class A Avoiding Electromagnetic Interference The monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The monitor is suitable for use in all establishments other than those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 312 Emissions test RF emissions CISPR 11 Compliance Class B 24 Specifications Avoiding Electromagnetic Interference The monitor, with the following measurements and interfaces:
ECG/Respiration, NBP, SpO2 Sensor M2501A), LAN is suitable for use in all establishments including those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 1, Pressure, Temperature, CO2 (only Mainstream 1. excluding Nellcor OxiMax technology Avoiding Electromagnetic Interference (Resp) The respiration (Resp) measurement is a very sensitive measurement that measures a very small signal. Technological limitations do not allow higher immunity levels than 1 V/m for radiated RF electromagnetic fields and 1 Vrms for conducted disturbances induced by RF fields. Electromagnetic fields with field strengths above 1 V/m and conducted disturbances above 1 Vrms may cause erroneous measurements. Therefore Philips recommends that you avoid using electrically radiating equipment in the close proximity of this measurement. WARNING The monitor should not be used next to or stacked with other equipment. If you must stack the monitor, you must check that normal operation is possible in the necessary configuration before you start monitoring patients. Electromagnetic Immunity The monitor is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below. IEC 60601-1-2 test level 6 kV contact 8 kV air 6 kV contact 8 kV air Compliance level Electromagnetic environment guidance 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode
<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec
<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5 sec Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial and/or hospital environment Mains power quality should be that of a typical commercial and/or hospital environment Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the monitor requires continued operation during power mains interruptions, it is recommended that the monitor is equipped with an internal battery or is powered from an uninterruptible power supply. 313 Immunity test Electrostatic discharge
(ESD) IEC 61000-4-2 Electrical fast transient/
burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 24 Specifications Immunity test Power frequency (50/
60 Hz) magnetic field IEC 61000-4-8 IEC 60601-1-2 test level 3 A/m Compliance level Electromagnetic environment guidance 3 A/m Power frequency magnetic fields should be a t levels characteristic of a typical location in a typical commercial and/or hospital environment In this table, UT is the a.c. mains voltage prior to application of the test level. Recommended Separation Distance WARNING This equipment generates, uses and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. The monitor, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements. In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). The values given in brackets are for respiration. Portable and mobile RF communications equipment should be used no closer to any part of the monitor, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with this symbol:
Immunity test Conducted RF IEC 61000-4-6 IEC 60601-1-2 test level 3 Vrms 150 kHz to 80 MHz Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz Compliance level Electromagnetic environment guidance 3 Vrms
(1 Vrms for respiration) 3 V/m
(1 V/m for respiration) For short range radio, see note1. Recommended separation distance:
d = 1.2P for respiration:
d = 3.5P Recommended separation distance:
80 MHz to 800 MHz: d = 1.2P 80 MHz to 800 MHz for respiration: d = 3.5P 800 MHz to 2,5 GHz: d = 2.3P 800 MHz to 2,5 GHz for respiration: d = 7.0P 2.0 to 2,3 GHz for short range radio: d = 7.0P 314 24 Specifications 1. If ECG/SpO2 signals are acquired from a telemetry device via short range radio the compliance level is 3V/m except in the range 2.0 to 2.3 GHz where it is 1 V/m. Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the monitor is used exceeds the applicable RF compliance level above, the monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the monitor. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Recommended separation distances from portable and mobile RF communication equipment The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the monitor as recommended below, according to the maximum output power of the communications equipment. In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). The values given in brackets are for respiration. Frequency of transmitter Equation 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.2P for respiration:
d = 3.5P d = 1.2P for respiration:
d = 3.5P d = 2.3P for respiration:
d = 7.0P for short range radio in the range 2.0 to 2.3 GHz:
d = 7.0P Rated max. output power of transmitter Separation distance 0.01 W 0.1 W 1 W 10 W 100 W 0.1 (0.4) m 0.4 (1.1) m 1.3 (3.5) m 3.8 (11.1) m 12.0 (35.0) m Separation distance Separation distance 0.1 (0.4) m 0.4 (1.1) m 1.3 (3.5) m 3.8 (11.1) m 12.0 (35.0) m 0.2 (0.7) m 0.7 (2.2) m 2.3 (7.0) m 7.3 (22.1) m 23.0 (70.0) m Electrosurgery Interference/Defibrillation/Electrostatic Discharge The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation. This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magnetic fields (MRI). 315 24 Specifications Fast Transients/Bursts The equipment will return to the previous operating mode within 10 seconds without loss of any stored data. If any user interaction is required, the monitor indicates with a technical alarm (INOP). Restart time After a power interruption, an ECG wave will be shown on the display after 30 seconds maximum. 316 25 25Default Settings Appendix This appendix documents the most important default settings of your monitor as it is delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your monitor. The monitor's default settings can be permanently changed in Configuration Mode. NOTE If your monitor has been ordered pre-configured to your requirements, the settings at delivery will be different from those listed here. Alarm and Measurement Default Settings The default wave speed for all measurements except Respiration is 25 mm/sec. For Respiration the default wave speed is 6.25 mm/sec. In the following tables, settings may be entered only once per table row if they are the same for all patient categories. Alarm Default Settings Alarm Settings Alarm Volume Alarms Off Pause Al. 5min Pause Al. 10min Auto Alarms Off AlarmOffReminder Visual Latching Audible Latching Alarm Reminder Reminder Time Alarm Sounds RedAlarmInterval Yel.Al. Interval Factory Default H10/H20/H40 H30/H31 (deviations from H10/H20/
H40) 5 2 min Enabled Enabled Off Off Red&Yellow Red&Yellow On 3 min Traditional 10 sec 20 sec Red Only Off 317 25 Default Settings Appendix Alarm Settings Alarm Low Red Alarm Volume Yell.AlarmVolume INOP Volume AutoIncrease Vol IncreaseVolDelay Keep Blinking Relay1 Sensitiv. Relay2 Sensitiv. Relay3 Sensitiv. CyanRelayLatency Yel.RelayLatency Alarm Text NoCentrMonMinVol Factory Default H10/H20/H40 H30/H31 (deviations from H10/H20/
H40) 2 4 AlarmVol. +2 AlarmVol. +0 AlarmVol. +0 2 Steps 20 sec No R&Y&C Red&Yellow Red 5 sec 2 sec Standard On ECG, Arrhythmia, ST and QT Default Settings ECG Settings High Limit Low Limit ECG/Arrhy Alarms Alarm Source ECG QRS Volume Primary Lead Secondary Lead Analysis Mode Lead Placement Mod.LeadPlacment Filter AutoFilter Default ECG Size Color Asystole Thresh. ExtrTachy Tachy Clamp ExtrBrady Brady Clamp ECG Alm Off INOP 318 Factory Defaults Adult 120 bpm 50 bpm On Auto On 1 II V Multi Lead Standard Off Monitor Off Size x1 Green 4.0 sec 20 bpm 200 bpm 20 bpm 40 bpm Cyan Pedi 160 bpm 75 bpm On Auto On 1 II V Multi Lead Standard Off Monitor Off Size x1 Green 4.0 sec 20 bpm 220 bpm 20 bpm 40 bpm Cyan Neo 200 bpm 100 bpm On Auto On 1 II V Multi Lead Standard Off Monitor Off Size x1 Green 3.0 sec 20 bpm 240 bpm 20 bpm 50 bpm Cyan 25 Default Settings Appendix Factory Defaults ECG Settings Fallback Alarms Off AlarmSource Sel. Va Lead Vb Lead SyncPulse Sensit SyncPulse Marker PulseAlarms Tele Arrhythmia Default Settings Adult On Enabled Enabled V2 V5 Medium On Enabled Arrhythmia Settings Arrhythmia Pause Threshold VTach HR VTach Run Vent Rhythm SVT HR SVT Run PVCs/min Non-Sustain Vent Rhythm Run PVCs Pair PVCs R-on-T PVCs V.Bigeminy V.Trigeminy PVCs/min Multif.PVCs Pacer n.Cap Pacer n.Pac Pause Missed Beat SVT Afib Irregular HR HR Alarms TimeOut 1st TimeOut 2nd Factory Defaults Adult On 2.0 sec 100 5 14 180 5 10 On On On On On On On On On On On On On On On On Short Yellow 3 min 10 min Pedi On Enabled Enabled V2 V5 Medium On Enabled Pedi On 2.0 sec 120 5 14 200 5 5 On On On On On On On On On On On On On On On On Short Yellow 3 min 10 min Neo On Enabled Enabled V2 V5 Medium On Enabled Neo Off 1.5 sec 150 5 14 210 5 5 On On On On On On On On On On On On On On On On Short Yellow 3 min 10 min 319 25 Default Settings Appendix Factory Defaults Arrhythmia Settings Adult Yes Cardiotach Msg On Some ECG Al INOP ST and QT Default Settings Factory Defaults Adult Single ST On On On
-80 ms 48 ms J+60 Factory Defaults Adult On
+2.0 mm
-2.0 mm
+1.0 mm
+1.0 mm Factory Defaults Adult All 500 ms 60 ms On On Off Bazett Lead-independent ST Settings ST Alarm Mode Alarms ST Analysis ST-Index ISO Point J Point ST Point Lead I, II, III, V, aVR, aVL, V1-6, MCL Settings ST Analysis For Alarm Mode = Single ST ST (Label) High ST (Label) Low For Alarm Mode = Multi ST ST (Label) High ST (Label) Low QT Settings QT Lead QTc High Limit QTc High Limit QTc High Alarm QTc High Alarm QT Analysis QTc Formula 320 Pedi Yes On Pedi Single ST On Off Off
-80 ms 48 ms J+60 Pedi Off
+2.0 mm
-2.0 mm
+1.0 mm
+1.0 mm Pedi All 480 ms 60 ms On On Off Bazett Neo Yes On Neo Single ST On Off Off
-80 ms 48 ms J+60 Neo Off
+2.0 mm
-2.0 mm
+1.0 mm
+1.0 mm Neo All 460 ms 60 ms On On Off Bazett Pulse Default Settings 25 Default Settings Appendix Pulse Settings Alarm Source Pulse (source label) System Pulse Alarms Off AlarmSource Sel. Pulse Alarm Settings Pulse (SpO) Pulse Alarms High Limit Low Limit ExtrBrady Brady Clamp ExtrTachy Tachy Clamp Factory Defaults Adult Auto On SpO Enabled Enabled Pedi Auto On SpO Enabled Enabled Factory Defaults H10/H20/H40 Adult On Off 120 bpm 50 bpm 20 bpm 40 bpm 20 bpm 200 bpm Pedi On Off 160 bpm 75 bpm 20 bpm 40 bpm 20 bpm 220 bpm Neo Auto On SpO Enabled Enabled Neo On Off 200 bpm 100 bpm 20 bpm 50 bpm 20 bpm 240 bpm Pulse alarms use the settings of the currently selected Pulse alarm source. Respiration Default Settings Respiration Settings High Limit Low Limit Apnea Time Alarms Resp Detection Color Factory Defaults Adult 30 rpm 8 rpm 20 sec On On Auto
(Trigger Mode) Yellow Pedi 30 rpm 8 rpm 20 sec On On Auto
(Trigger Mode) Yellow Neo 100 rpm 30 rpm 20 sec On On Auto
(Trigger Mode) Yellow 321 25 Default Settings Appendix SpO2 Default Settings SpO2 Settings Mode Repeat Time Alarms QRS Volume Tone Modulation Tone Mod. Type Perfusion Average NBP Alarm Suppr. Extd. Auto OnOff Color Average in Mon. Signal Quality Factory Defaults Adult Continuous 15 min On 1 Yes Enhanced On 10 sec On Disabled Cyan (light blue) No On Pedi Continuous 15 min On 1 Yes Enhanced On 10 sec On Disabled Cyan (light blue) No On Neo Continuous 15 min On 1 Yes Enhanced On 10 sec On Disabled Cyan (light blue) No On SpO2 Alarm Default Settings Setting Desat Limit Low Limit High Limit Desat Delay High Alarm Delay Low Alarm Delay SmartAlarmDelay (SAD) High Alarm Delay (SAD) Low Alarm Delay (SAD) Label Pulse settings Pulse (SpO) For all other Pulse default settings, refer to the Pulse Default Settings table. Adult 80 90 100 20 sec 10 sec 10 sec Off Short Short SpO On Pedi 80 90 100 20 sec 10 sec 10 sec Off Short Short SpO On Neo 80 85 95 20 sec 10 sec 10 sec Off Short Short SpO On NBP Default Settings NBP Settings Mode Alarms from High Limit 322 Factory Defaults Adult Auto Sys. 160/90 (110) Pedi Auto Sys. 120/70 (90) Neo Manual Sys. 90/60 (70) NBP Settings Low Limit Alarms NBP Repeat Time Pulse (NBP) Unit Done Tone Start Time VP Pressure Reference Color 25 Default Settings Appendix Factory Defaults Adult 90/50 (60) On On 10 min On mmHg Off Synchronized 60 mmHg Auscultatory Red Pedi 70/40 (50) On On 10 min On mmHg Off Synchronized 40 mmHg Auscultatory Red Neo 40/20 (24) On On 10 min On mmHg Off Synchronized 30 mmHg Invasive Red Temperature Default Settings Temp Settings Low Limit High Limit Alarms Unit Range Color Factory Defaults Adult 36 39 On C 35...43 Green Pedi 36 39 On C 35...43 Green Invasive Pressure Default Settings ABP, ART, Ao, BAP, FAPP,P P1, P2, P3, P4, UAP Settings Alarms from High Limit Low Limit Alarms Extreme Alarms Extreme High Extreme Low Sys. High Clamp Sys. Low Clamp Scale Mean only Filter Factory Defaults Adult Sys. 160/90 (110) 90/50 (70) On Disabled 15 15 190/100 (125) 80/45 (65) 150 No 12 Hz Pedi Sys. 120/70 (90) 70/40 (50) On Disabled 10 10 140/80 (100) 60/35 (45) 100 No 12 Hz Neo 36 39 On C 35...43 Green Neo Sys. 90/60 (70) 55/20 (36) On Disabled 5 5 105/75 (75) 45/15 (30) 100 No 12 Hz 323 25 Default Settings Appendix ABP, ART, Ao, BAP, FAPP,P P1, P2, P3, P4, UAP Settings Mercury Cal Artifact Suppr. Unit Color CVP, RAP, LAP, UVP Settings Alarms from High Limit Low Limit Alarms Extreme Alarms Extreme High Extreme Low Mean High Clamp Mean Low Clamp Scale Mean only Filter Mercury Cal Artifact Suppr. Unit Color PAP Settings Alarms from High Limit Low Limit Alarms Extreme Alarms Extreme High Extreme Low Dia. High Clamp Dia. Low Clamp Scale Mean only Filter Mercury Cal Artifact Suppr. 324 Factory Defaults Adult Yes 60 sec mmHg Red Factory Defaults Adult Mean 14/6 (10) 6/-4 (0) On Enabled 5 5 20/10 (15) 0/-5 (-5) 30 Yes 12 Hz Yes 60 sec mmHg Cyan (light blue) Factory Defaults Adult Dia. 34/16 (20) 10/0 (0) On Enabled 5 5 45/20 (25) 5/-5 (-5) 30 No 12 Hz Yes 60 sec Pedi Yes 60 sec mmHg Red Pedi Mean 10/2 (4) 2/-4 (0) On Enabled 5 5 15/5 (10) 0/-5 (-5) 30 Yes 12 Hz Yes 60 sec mmHg Cyan (light blue) Pedi Dia. 60/4 (26) 24/-4 (12) On Enabled 5 5 65/5 (35) 15/-5 (5) 30 No 12 Hz Yes 60 sec Neo Yes 60 sec mmHg Red Neo Mean 10/2 (4) 2/-4 (0) On Enabled 5 5 15/5 (10) 0/-5 (-5) 30 Yes 12 Hz Yes 60 sec mmHg Cyan (light blue) Neo Dia. 60/4 (26) 24/-4 (12) On Enabled 5 5 65/5 (35) 15/-5 (5) 30 No 12 Hz Yes 60 sec 25 Default Settings Appendix PAP Settings Unit Color ICP, IC1, IC2 Settings Alarms from High Limit Low Limit Alarms Extreme Alarms Extreme High Extreme Low Mean Low Clamp Mean High Clamp Scale Mean only Filter Mercury Cal Artifact Suppr. Unit Color Factory Defaults Adult mmHg Yellow Factory Defaults Adult Mean 14/6 (10) 6/-4 (0) On Enabled 10 10 20/10 (-5) 0/-5 (0) 30 Yes 12 Hz Yes 60 sec mmHg Magenta CO2 Default Settings CO2 Settings etCO Low etCO High imCO High CO Alarms Unit Scale imCO NO Corr. (only M3015A/M3016A) Oxygen Corr. (only M3014A) Gas Corr. (only M3014A) Humidity Corr. Max Hold awRR Factory Defaults Adult 25 60 4 On mmHg 50 mmHg On Off 20%
Off BTPS 20 s On Pedi mmHg Yellow Pedi Mean 10/2 (4) 2/-4 (0) On Enabled 10 10 15/5 (-5) 0/-5 (0) 30 Yes 12 Hz Yes 60 sec mmHg Magenta Pedi 25 60 4 On mmHg 50 mmHg On Off 20%
Off BTPS 20 s On Neo mmHg Yellow Neo Mean 10/2 (4) 2/-4 (0) On Enabled 10 10 15/5 (-5) 0/-5 (0) 30 Yes 12 Hz Yes 60 sec mmHg Magenta Neo 25 60 4 On mmHg 50 mmHg On Off 20%
Off BTPS 20 s On 325 25 Default Settings Appendix CO2 Settings awRR Alarms High Limit (awRR) Low Limit (awRR) Apnea Time Color Factory Defaults Adult On 30 8 20 sec Yellow Pedi On 30 8 20 sec Yellow Neo On 60 30 20 sec Yellow 326
#
10-lead placement (ECG) 115 12-lead placement (ECG) 115 3-lead placement (ECG) 113 5-lead placement (ECG) 113 A AAMI ECG lead labels 112 abdominal breathing 162 and Resp electrode placement 162 aberrantly conducted beats 130 accessories 10-electrode cable sets 263 3-electrode cable sets 262 5-electrode cable sets 262 5-electrode one piece cables 264 6-electrode cable sets 262 CO2 209 CO2 (mainstream) 279 ECG 105 NBP 183 adult cuffs 266 comfort cuffs 264 disposable cuffs 266 multi-patient comfort cuff kits 264 neonatal/infant cuffs (single patient) 267 reusable cuffs 264 single patient, adult/pediatric soft cuffs 266 Pulsion 270 resp 261 set combiners and organizers 263, 264 trunk cables 261 active alarms 47 address, Philips 284 addressograph (printer configuration setting) 242 adjusting ST measurement points 143 adjusting wave scale (pressure) 199 adjusting wave size (CO2) 210 admitting a patient quick admit 88 airway adapter 209 CO2, microstream accessory 209 alarm latching 58, 59, 135 alarm limits 54, 56 checking 54 1Index monitoring paced patients 129 options 129 relearning 134 relearning and lead fallback 134 status messages 132 switching on/off 56 understanding the display 131 arrhythmia alarms 47, 135, 137, 139, 298 adjusting alarm limits 136 all yellow on/off 136 chaining 137 latching 58, 59 multiple 137 PVC-related alarms 139 sinus and SV rhythm ranges 300, 301 switching on/off 56 timeout periods 136 arrhythmia monitoring 127 and defibrillation 127 arrhythmia options 123 arrhythmia relearning 122 with EASI INOP 122 arterial pressure source 201 artifact suppression (pressure) 199 atrial fibrillation and flutter 130 audible latching (arrhythmia alarms) 135 auto alarm limits 56 switching on/off 56 auto detection mode (Resp) 163 automatic arrhythmia relearn 134 automatic default setting 31 automatic NBP repeat time 186 autosize 109 ECG wave 109 awRR alarm 212 limits 212 awRR alarms 212 CO2 209 B baseline 150 ST map, updating 150 basic arrhythmia option 123, 129 battery 249, 252, 253, 255, 285 and display brightness 255 battery reports 252 charge status 252 conserving power 255 327 narrow 56 report 221 ST 139 switching auto limits on/off 56 using automatic limits 56 wide 56 alarm source selection, disabled 159 alarms 47 active 47 alphabetical listing 61 apnea delay time (Resp) 164 arrhythmia 129 awrr limits 212 chaining 137 CO2, awRR 212 desat, SpO2 181 effect on pressure alarms during zero 196 high priority 47 INOP 47 ISO/IEC standard 50 limit, SpO2 301 patient messages 61 physiological 61 recordings 60 red 47 selftest 59 SpO2 specific 176 ST 146 testing 59 tone configuration 49 traditional 50 yellow 47 alphabetical listing of alarms 61 analog output ECG 105 apnea alarm delay CO2 209 apnea alarm delay time (Resp) 164 apnea alarms 164 and Resp detection modes 163 arrhythmia 129 aberrantly conducted beats 130 analysis, how it works 129 atrial fibrillation and flutter 130 beat labels 131 initiating learning 134 intermittent bundle branch block 131 learning during ventricular rhythm 134 levels of analysis 123, 129 monitoring non-paced patients 129 indicators 47 malfunction indicator 250 monitoring time 250 safety information 127, 164 status indicator 250 symbol 285 time to empty 251 time to full 251 battery eject symbol 285 battery performance 254 optimizing 254 beat labels 131 arrhythmia 129 blood pressure. See also NBP (non-
invasive) or PRESS (invasive) 183 C calculating cerebral perfusion 201 calculating temperature difference 192 calibrating 190 calibration 190, 197 NBP 183 pressure transducer 197 cardiac overlay 162, 163 and Resp detection modes 163 when measuring Resp 162 cardiotach alarms 123 cerebral perfusion 201 chaining 137 change screen window 29 changing ECG lead sets 112 changing Resp detection mode 163 changing Resp wave size 164 changing Resp wave speed 164 checking battery charge 252 cleaning 245 infection control 245 monitoring accessories 247 CO2 209 airway adapter 209 alarms, awRR 212 awRR alarm limits 212 correction, humidity 211 correction, N2O 211 corrections 211 FilterLine 209 measuring microstream 209 microstream accessories 209 microstream extension 209 removing exhaust gases 208, 210 wave scale, adjusting 210 CO2 (mainstream) 279 connecting temperature probe 191 connection direction symbol 285 328 connectors 287 conventional 12-lead ECG 116 correcting the NBP measurement 185 CPAP (RESP) 163 cuff 185, 186 pressure, NBP 186 selection, NBP 185 current view ST map 147 D DC power symbol 285 default profile 31 default settings 317 defibrillation 127 and arrhythmia monitoring 127 and ECG monitoring 127 defibrillator proof symbol 285 desat alarm, SpO2 181 detection modes (Resp) 163 disinfecting 245 infection control 245 display 131, 141, 162, 186 arrhythmia 129 ECG 105 NBP 183 Resp 162 ST 139 display brightness 255 display settings 30 dual Temp measurement 192 dyshemoglobins 173 intravascular (SpO2) 173 E early systolic blood pressure, NBP 186 EASI 122 ECG monitoring 122 lead placement 161 EASI ECG lead labels 112 ECG 105 alarms off (Config Mode) 126 changing lead sets 112 choosing electrode sites 111 conventional 12-lead 116 external pacing electrodes 127 fusion beat pacemakers 127 intrinsic rhythm 127 modified 12-lead 116 New Lead Setup 112 pacemaker failure 127 rate adaptive pacemakers 127 wave size 109 ECG cable 127 for operating room 127 ECG cables, connecting 105 ECG connector 105 ECG electrode colors 112 ECG electrode placement 127 during electrosurgery 127 ECG gain 236 ECG lead labels 112 ECG leads monitored 112 ECG report 236, 243 lead layout 236 ECG safety information 127 ECG source tracking 101 ECG wave 109 autosize 109 calibration bar 109 ectopic status messages (arrhythmia monitoring) 133 electrical output symbol 285 electrode placement (ECG) 105, 116 conventional 12-lead 116 modified 12-lead 116 electrode placement (Resp) 161, 162 with abdominal breathing 162 with lateral chest expansion 162 electrosurgery 127 and ECG 127 EMC interference 164 Resp 162 end case reports 237 enhanced arrhythmia option 123, 129 exclamation mark symbol 285 exhaust gases, removing 208, 210 external pacing electrodes 127 and ECG monitoring 127 extreme bradycardia alarm 125 extreme rate alarms 125 extreme tachycardia alarm 125 F fallback (ECG) 112 FilterLine 209 CO2, microstream accessory 209 flushing invasive pressure accessories 193 fusion beat pacemakers 127 and ECG monitoring 127 G gas cylinder empty, disposing of 259 getting started 37 global trend time 228 H horizon trend 228 trend time 228 HR = RR (Resp) 162 HR alarms 127 when arrhythmia off 127 HR alarms off (Config Mode) 126 HR and pulse alarm source selection 159 humidity correction 211 CO2 209 I IEC ECG lead labels 112 IMV (Resp) 163 indicators 47 battery malfunction 250 infection control 245 disinfecting 245 Information Center 93 central recording 231 transferring patients 93 INOPs 47 indicators 47 installation connectors 287 intermittent bundle branch block 131 intermittent mandatory ventilation
(Resp) 163 interruption symbol 285 intravascular dyshemoglobins (SpO2) 173 intrinsic rhythm 127 ISO point (ST) 144 J J point (ST) 144 K keyboard, on screen 27 keys 27 alarms 47 pop-up 27 L latching 58, 59 alarms 47 alarms, behavior 59 latching arrhythmia alarms 135 lateral chest expansion (neonates) 162 monitoring Resp 162 lead fallback 134 and arrhythmia relearning 134 lead fallback (ECG) 112 lead labels (ECG) 112 lead placement 161 for Resp measurement 161 leads monitored (ECG) 112 Leads Off INOP (ECG) 112 levels of arrhythmia analysis 129 M main setup 25 maintenance 257 schedule 257 malfunction symbols battery 252, 255 manual detection mode (Resp) 163, 164 and apnea alarms 164 manufacture date symbol 285 manufacturer's information 284 map 147 ST 139 Mason-Likar lead system 116 measurement points, ST 143 measurement server ECG connector 105 measurement settings 30 measurement setup menu 24 measurements 32, 38 menu 24, 25 main setup 25 measurement setup 24 messages INOP 47 methemoglobin (SpO2) 173 microstream CO2 209 modified 12-lead ECG 116 monitor defaults 317 monitor revision 37 how to find 37 monitoring starting 37 N N2O correction 211 CO2 209 narrow alarm limits 56 NBP 183 adult cuffs 266 ANSI/AAMI SP10-1992 183 calibrating 190 comfort cuff kits 264 comfort cuffs 264 cuff pressure 186 cuff, applying 185 cuff, selecting 185 cuff, tightness 185 disposable cuffs 266 how the measurement works 183 measurement correction 185 measurement limitations 184 measurement methods, auto 184 measurement methods, manual 184 measurement methods, sequence 184 measurement methods, stat 184 neonatal cuffs (disposable) 267 numerics 186 oscillometric method 183 pediatric cuffs 266 preparing to measure 185 repeat time 186 reusable cuffs 264 single patient, adult/pediatric soft cuffs 266 site inspection 173 time of last measurement 186 units 186 venous puncture 190 neonates 162 Resp electrode placement 162 new features 41 non-invasive blood pressure. See NBP 183 non-paced patients 129 arrhythmia monitoring 127 numerics 186 explanation of NBP display 186 O on-screen keyboard 27 operating room ECG cable 127 orange ECG cable 127 organizers 263, 264 oscillometric NBP measurement method 183 overlapping screen trends 228 P pace pulse rejection (ECG) 106, 108 about 31 switching on/off 56 paced patients 109, 127, 129 arrhythmia monitoring 127 repolarization tails 109 safety information 127, 164 setting status 127 paced status checking 54 pacemaker failure 127 parameter scales 226 patient 183 category, NBP 183 329 patient alarm messages 61 patient reports 242 contents 242 performance specifications 298 performance test 312 perfusion indicator 173, 181 Philips contact information 284 physiological alarms 47 pleth wave 181 pop-up keys 27 preparing skin 105 for ECG 105 pressure alarms during zero 196 arterial source 201 calibration pressure 197 cerebral perfusion, calculating 201 performance specifications 298 wave scale 199 wave size 109 pressure accessories 270 pressure artifact suppression 199 pressure of NBP cuff 186 pressure transducer 197 calibration 190, 197 print job 239 suspended 239 printer 238, 239, 241 settings 31, 101, 317 status messages 132 unavailable 239 printing 235 ST map reports 150 probes 191 disposable temperature 191 profiles 30, 31 default profile 31 patient category 30 swapping a complete profile 31 pulse 157, 158 alarms 47 system pulse source 157 pulse numerics for SpO2 173 PVC-related alarms 139 Q QRS volume, changing 110 QT alarms 155 QT baseline 155 QT measurement algorithm 152 QT monitoring 153 limitations 153 QT/QTc monitoring 152 330 quick admit 88 R radiated field immunity 164 Resp 162 rate adaptive pacemakers 127 and ECG monitoring 127 recording preventing fading ink 233 recording alarms 60 relearning arrhythmia 134 repolarization tails 109 reports 235 alarm limits 54, 56 battery reports 252 contents 242 ECG 105 re-routing 239 scheduled 237 ST map 147 stopping printouts 236 re-routing reports 239 resp accessories 261 Resp alarms 164 apnea alarm delay time 164 Resp detection level 164 and apnea detection 164 Resp detection modes 163 and cardiac overlay 162 Resp display 162 Resp monitoring 162 and cardiac overlay 162 Resp safety information 164 Resp wave 164 changing size 164 rhythm status messages (arrhythmia monitoring) 132 S safety information 127, 164 batteries 256 ECG 105 Resp 162 safety test 312 safety tests visual inspection 257 scale 109, 164 ECG wave 109 Resp wave 164 scales 226 for trends waveforms 226 scheduled reports 237 screen trend 228 trend time 228 selftest 59 alarms 47 sequence mode 189 set combiners 263, 264 setting up the sequence 189 settings 31, 101, 317 about 31 default 317 screen settings 31 synchronized telemetry and monitor 101 settings blocks 30 short yellow alarms on/off 136 signal quality of SpO2 175 sinus and SV rhythm ranges 300, 301 skin preparation 105 ECG 105 SmartKeys symbol 285 source tracking 101 ECG 105 specifications 298 arrhythmia 129 SpO2 alarms specific to SpO2 176 assessing suspicious reading 175 perfusion indicator 173, 181 pleth wave 181 pulse numerics 173 signal quality 175 site inspection 173 site selection 172 SpO2 desat alarm 181 ST 139 adjusting alarm limits 136 alarms 47 ensuring diagnostic quality 139 filtering 139 measurement points, adjusting 143 snippets 141 ST display 141 ST map 147 report, printing printing 235 ST map report 150 scale, changing 150 scale 109, 164 ST map 147 task window 150 trending interval, changing 150 trending priority 150 ST maps 147 ST point 144 standard 10-lead placement 115 standard 3-lead placement 113 standard 5-lead placement (ECG) 113 standby symbol 285 status log printing 235 status messages 132 printer 238, 239, 241 ectopic 133 rhythm 132 sterilizing 245 status messages (arrhythmia) 132, 133 infection control 245 stopping reports printouts 236 surgical ECG cable 127 suspicious SpO2 reading 175 symbols 285 battery 252, 255 system pulse 157 systolic blood pressure, NBP, early 186 T Tamb 192 task window for ST map 150 Tcereb 192 telemetry alarms 101 suspending at bedside 101 telemetry device unpairing 218 temperature alarm settings 191 connecting probe to monitor 191 difference, calculating 192 dual Temp measurement 192 extended label set 192 first 192 making a measurement 191 probe, disposable 191 probe, selecting 191 second 192 temperature probe 191 testing alarms 59 tone configuration, alarm 49 transferring centrally-monitored patients 93 transport brightness setting 255 trend time 228 global 228 trend view ST map 147 trending interval 150 ST map 147 trends setting parameter scales 226 trends pop-up keys 221 trends priority list ST map 147 troubleshooting CO2 209 trunk cables 261 Ttymp 192 Tvesic 192 U unpairing 218 V V electrode placement (ECG) 115 venous puncture 190 visual latching (arrhythmia alarms) 135 W wave 199, 210 scale (CO2) 210 scale (pressure) 199 size (CO2) 210 size (pressure) 199 wave size 109 Resp 162 wave size (ECG) 109 wave speed (Resp) 164 what's new 41 wide alarms limits 56 wired network connection symbol 285 Z zero 196 effect on pressure alarms 196 zeroing pressure transducer 197 331 332 Part Number 453564547171 Published in Germany 04/2015
*453564547171*
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2017-06-12 | 2412 ~ 2462 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2017-06-12
|
||||
1 2 | Applicant's complete, legal business name |
Philips Medical Systems North America Co.
|
||||
1 2 | FCC Registration Number (FRN) |
0025978651
|
||||
1 2 | Physical Address |
3000 Minuteman Road
|
||||
1 2 |
Andover, Massachusetts 01810-1099
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
T******@ctcadvanced.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
PQC
|
||||
1 2 | Equipment Product Code |
WLANBV3
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
D**** S****
|
||||
1 2 | Title |
Principal Scientist / Project Leader
|
||||
1 2 | Telephone Number |
+ 1 9********
|
||||
1 2 | Fax Number |
1-978********
|
||||
1 2 |
d******@philips.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | WLAN Module IEEE 802.11 a/b/g/n | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Single Modular Approval | ||||
1 2 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | Output power listed is peak conducted. This device supports 802.11b, 802.11g and 802.11n with a 20 MHz and 40 MHz bandwidth mode. RF exposure compliance is addressed for 1.1310 and 2.1091 MPE limits. Integrators and End Users must be provided with transmitter operation conditions for satisfying RF exposure compliance. Class II permissive change to allow specific portable host configiurations that are collocated with with module FCC ID: PQC-SRRBV1. The highest reported SAR values for body and simultaneous transmission conditions across all devices under this FCC ID are 0.48 W/kg and 0.53 W/kg respectively. | ||||
1 2 | Output power listed is conducted. This device supports 802.11a and 802.11n with a 20 MHz and 40 MHz bandwidth mode. Approval is for operation as a client only device without radar detection or ad-hoc capability. RF exposure compliance is addressed for 1.1310 and 2.1091 MPE limits. Integrators and End Users must be provided with transmitter operation conditions for satisfying RF exposure compliance. Class II permissive change to allow specific portable host configiurations that are collocated with with module FCC ID: PQC-SRRBV1. The highest reported SAR values for body and simultaneous transmission conditions across all devices under this FCC ID are 0.48 W/kg and 0.53 W/kg respectively. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
CTC advanced GmbH (former CETECOM ICT Services )
|
||||
1 2 | Name |
G******** S********
|
||||
1 2 | Telephone Number |
49-68********
|
||||
1 2 | Fax Number |
49-68********
|
||||
1 2 |
t******@ctcadvanced.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2412.00000000 | 2462.00000000 | 0.0204000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | CC | 5180 | 5240 | 0.0129 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15E | CC | 5260 | 5320 | 0.0145 | |||||||||||||||||||||||||||||||||||
2 | 3 | 15E | CC | 5500 | 5580 | 0.0182 | |||||||||||||||||||||||||||||||||||
2 | 4 | 15E | CC | 5660 | 5700 | 0.0162 | |||||||||||||||||||||||||||||||||||
2 | 5 | 15E | CC | 5745 | 5825 | 0.0129 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC