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User Manual FCC ID: ZLZ-EPM Patient Monitor ePM 15M, ePM 12M, ePM 10M, ePM 15, ePM 12, ePM 10 Mindray Shenzhen Mindray BIO-Medical electronics Co.,LTD. Intellectual Property Statement Shenzhen Mindray BIO-Medical electronics Co.,LTD.(hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. is the trademark, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners. This posting serves as notice under 35 U.S.C.287(a) for Mindray patents: http://www.mindrayna.com/patents. Manufacturers Responsibility Contents of this manual are subject to changes without prior notice. Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local requirements;
the product is used in accordance with the instructions for use. WARNING Only skilled/trained clinical professionals should operate this equipment. It is important for the hospital or organization that uses this equipment to perform a recommended service/maintenance plan. Neglect of this may result in machine breakdown or personal injury. Service Mindray maintains a network of service representatives and factory-trained distributors. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, contact Mindray service. In North America contact the Service Department at (800) 288-2121, ext: 8116 for Technical Support or (201) 995-8000 for assistance in determining the nearest field service location. Please include the instrument model number, the serial number, and a description of the problem with all requests for service. Any questions regarding the warranty should be directed to the local sales or service representative. II Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety. This manual is based on the maximum configuration and therefore some contents may not apply to the product. If you have any question, please contact Mindray. This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed. Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of patients. Illustrations All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on the patient monitor. Conventions Italic text is used in this manual to quote the referenced manuals, chapters, sections and formulas. Bold text is used to indicate the screen texts and names of hard keys. is used to indicate operational procedures. IV 1 Safety 1.1 Safety Information WARNING Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. NOTE Provides application tips or other useful information that does not involve patient or user risk. 1.1.1 Warnings WARNING patient injury may result. Patient with a pacemaker on ventricular paced patients, episodes of Ventricular Tachycardia may not always be detected. Do not rely entirely upon the systems automated arrhythmia detection algorithm. Keep pacemaker patients under close surveillance. This equipment is used for a single patient at a time. To avoid explosion hazards, do not use the equipment in the presence of oxygen-rich atmospheres, flammable anesthetics, or other flammable agents. Do not touch the equipments metal parts or connectors when in contact with the patient; otherwise Never mix patient electrode types or brands. Dissimilar metals or other incompatibilities may cause considerable baseline drift and may increase trace recovery time after defibrillation. To reduce the hazard of burns during high-frequency surgical procedure, ensure that the monitors cables and transducers never come into contact with the electro-surgery unit (ESU). The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result. MR unsafe: the N Series monitors are not intended to be used within the Magnetic Resonance (MR) Before connecting the equipment to the mains power, ensure that the voltage and frequency ratings Before putting the system into operation, the operator must verify that the equipment, connecting cables, and accessories are in correct working order and operating condition. To avoid risk of electric shock, the equipment must only be connected to mains power with protective earth, or operated on battery power. Do not touch the patient and live parts simultaneously. Otherwise patient injury may result. Do not touch the patient or metal parts in contact with the patient during defibrillation. Otherwise Do not open the equipment housings. All servicing and future upgrades must be carried out by of the power line are the same as those indicated on the equipments label or in this manual. serious injury or death could result. environment. trained and authorized personnel. 1 - 1 Do not rely exclusively on the audible alarm system for patient monitoring. Turning the alarm volume to a low level or off may result in a hazard to the patient. Always keep the patient under close surveillance. Alarm settings should be customized according to patient situations. Do not place the equipment or accessories in any position that might cause it to fall on the patient. Do not start or operate the equipment unless the setup was verified to be correct. To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard. Wrap and secure excess cabling to reduce risk of entanglement by patients or personnel. The physiological data and alarm messages displayed on the equipment are for reference only and cannot be directly used for diagnostic interpretation. The equipment should not be used as the sole basis for medical decisions. It must be used in conjunction with clinical signs and symptom. If any measurement seems questionable, first check the patients vital signs by alternate means and then check the equipment for proper functioning. 1.1.2 Cautions CAUTION Use only parts and accessories specified in this manual. Disposable accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy. Ensure that the equipment is supplied with continuous electric power during operation from the mains power or batteries. Sudden power failure may cause data loss. When no battery is installed, ensure that the monitor is supplied with continuous electric power during operation. Sudden power failure may lead to data loss. This equipment is intended for single patient use. Store and use the equipment in specified environmental condition. The monitor and accessories may not meet the performance specification due to aging, stored or used outside the specified temperature and humidity range. Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phones, X-ray equipment, and MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation. vibrations or other mechanical forces. Always install or carry the equipment properly to avoid damage caused by drops, impacts, strong Dry the equipment immediately in case of rain or water spray. Some settings are password protected and can only be changed by authorized personnel. Contact your department manager or biomedical engineering department for the passwords used at your facility. Do not loop the patient cabling into a tight coil or wrap around the device, as this can damage the Dispose of the package material as per the applicable waste control regulations. Keep it out of At the end of its service life, the equipment, as well as its accessories, must be disposed of in childrens reach. patient cabling. compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray. 1 - 2 1.1.3 Notes NOTE time. The equipment software copyright is solely owned by Mindray. No organization or individual shall resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by any means without due permission. Put the equipment in a location where it can be easily viewed and operated. The equipment uses a mains plug as isolation means to the mains power. Do not locate the equipment in a place difficult to access the mains plug. During normal use, the operator is expected to face the front of the equipment. Remove the battery before shipping the monitor or if it will not be used for an extended period of Remove the battery before transporting the equipment or if the equipment will not be used for a long time. The software was developed in compliance with IEC62304, to minimize the possibility of hazards arising from software errors. This manual describes all available features and options. The equipment configuration may not have all of them. Observance of this manual is a prerequisite for proper product performance and correct operation Keep this manual in the vicinity of the equipment so that it can be referenced when needed. and ensures patient and operator safety. 1.2 Equipment Symbols Symbol Description Symbol Description General warning sign Refer to instruction manual/booklet Serial number Catalogue number Date of manufacture Manufacturer USB connector Protected against vertically falling water drops per IEC 60529 Battery indicator Computer network Equipotentiality Alternating current Defibrillation-proof type CF applied part Defibrillation-proof type BF applied part 1 - 3 Symbol Description Symbol Description Stop USB NIBP start/stop Unlocking IBP zero key Calibration Menu Power On/Off Graphical record Gas outlet Output Gas inlet Input/output Pushing prohibited Non-ionizing electromagnetic radiation Authorised representative in the European Community Dispose of in accordance to local requirements Conforms to ANSI Std. ES60601-1, IEC Std. 60601-1-8, IEC Std. 60601-2-25, IEC Std. 60601-2-26, IEC Std. 60601-
2-27, IEC Std. 80601-2-30, IEC Std. 60601-2-34, IEC Std. 60601-2-49, ISO Std. 0601-2-55, ISO Std. 80601-2-56, and ISO Std. 80601-2-61 Certified to CAN/CSA Std. C22.2 No. 60601-1, No. 60601-1-6, No. 60601-1-8, No. 60601-2-25, No. 60601-2-26, No. 60601-2-27, No. 80601-2-30, No. 60601-2-34, No. 60601-2-49, No. 80601-2-55, No. 80601-2-56, and No. 80601-2-61 1 - 4 2 Equipment Introduction 2.1 Indications for Use The ePM 10M/ePM 12M/ePM 15M patient monitor, hereafter called the monitor, is intended to be used for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead, and 12-lead selectable, arrhythmia detection, ST segment analysis, QT/QTc monitoring, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide
(CO2), oxygen (O2), anesthetic gas (AG) and bispectral index (BIS). The monitor also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:
C.O. monitoring is intended for adult patients only. The arrhythmia detection and PAWP monitoring are intended for adult and pediatric patients only. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The monitor is not intended for helicopter transport, hospital ambulance, or home use. 2.2 Applied Parts The applied parts of the monitor are:
ECG electrode and leadwire SpO2 sensor Temp probe NIBP cuff IBP transducer C.O. sensor CO2 sampling line/nasal sampling cannula, water trap, and mask AG sampling line, water trap, airway adapter, and mask 2 - 1 2.3 System Components The monitor consists of the main unit, display, external modules, input devices and output devices. NOTE The monitor may not include all these components. Contact the local service personnel for available components. 2.3.1 Main Unit The main unit processes data from modules. 2.3.1.1 Front View
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(1) Alarm lamp When a physiological alarm or technical alarm occurs, this lamp lights and flashes corresponding with the alarm priority:
High priority alarms: the lamp quickly flashes red. Medium priority alarms: the lamp slowly flashes yellow. Low priority alarms: the lamp lights in cyan without flashing. Display NIBP Start/Stop hard key Press to start an NIBP measurement or stops the current NIBP measurement. Record Start/Stop key Press to start a recording or stop the current recording. Alarm Pause hard key Press to pauses the current alarms Alarm Reset hard key Press to acknowledge the on-going alarm.
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(7) Power indicator 2 - 2 On: when the AC power is connected. Off: when the AC power is not connected.
(8) Battery indicator Yellow: the battery is being charged. Green: the battery is fully charged. Flashing green: the monitor operates on battery power. Off: no battery is installed, or the battery is malfunctioning, or the monitor is powered off and no power is connected.
(9) Power switch Pressing this switch turns on the monitor. When the monitor is on, pressing and holding this switch turns off the monitor. 2.3.1.2 Left View
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(1) Temperature probe connector
(2) SpO2 probe connector
(3)IBP cable connector
(5) CO2 watertrap seat
(7) Gas outlet
(4) ECG cable connector
(6) NIBP cuff connector
(8) C.O. cable connector 2 - 3 2.3.1.3 Right View
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(1) Handle
(2) Recorder 2.3.1.4 Rear View
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(1) Alarm lamp When a physiological alarm or technical alarm occurs, this lamp lights and flashes corresponding with the alarm priority:
High priority alarms: the lamp quickly flashes red. Medium priority alarms: the lamp slowly flashes yellow. Low priority alarms: the lamp lights in cyan without flashing. AC Power input Equipotential Grounding Terminal When using the monitor together with other devices, connect their equipotential grounding terminals together to eliminate the potential difference between them.
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(6) Network Connector It is a standard RJ45 connector which connects the monitor to the central monitoring system
(CMS) or other network devices. USB connectors It connects USB devices, for example the barcode reader. VGA Connector It connects It connects a external display, which extends the display capability of your monitor. The contents displayed on the external display screen accords with those displayed on the monitor screen.
(7) Multifunctional Connector It outputs defibrillator synchronization signals, nurse call signals and analogy output signals. 2.3.2 External Modules The external modules are used to monitor the patients physiological parameters, record patient information and data, and connect external devices. The monitor provides the following modules:
Parameter modules: acquires and processes the patients data and sends the data to the main unit. BeneLink module: connects external devices. The monitor outputs data from external devices through the BeneLink module. 2.3.2.1 Available Modules Refer to 29Accessories for available modules. The monitor can simultaneously use maximum of two IBP modules. The other modules can only be used one at a time. Otherwise, the monitor will issue a module conflict prompt. For example, if a CO2 module is already loaded and then another CO2 module is inserted, the monitor will then prompt module conflict. To solve the problem of module conflict, just remove a module. 2.3.2.2 Example Module The parameter modules have similar structure:
The parameter label is marked at the upper left corner. Hard keys are located on the upper part. Patient cable connectors are located at the lower part. Take the IBP module as an example:
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(3) Setup hard key: enters or exits the IBP Setup menu. Zero hard key: enters the Zero IBP menu. Module status indicator On: the module works properly. Flashing: the module is initializing. Off: the module is not connected or the module fails.
(4) Patient cable connectors 2.3.3 Input Devices The monitor allows data entry through touchscreen, remote controller, hardkey and barcode reader. You can only use Mindray specified input devices. 2.3.4 Printing Devices You can use Mindray specified printer and/or recorder to output patient information and data. The monitor is configured with a build-in recorder. The printer can be connected to the monitor through the network to output patient reports. 2 - 6 3 Getting Started 3.1 Equipment Preparation Safety Information WARNING Use only installation accessories specified by Mindray. Connect only approved devices to this equipment. Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The system configuration must meet the requirements of the IEC 60601-1 medical electrical systems standard. Any personnel who connect devices to the equipments signal input/output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1. If you have any questions, please contact Mindray. If it is not evident from the equipment specifications whether a particular combination with other devices is hazardous, for example, due to summation of leakage currents, please consult the manufacturer or an expert in the field. A determination must be made that the proposed combination will not negatively affect the devices themselves or the patient's safety. regulations and keep it out of childrens reach. The equipment should be installed by Mindray authorized personnel. CAUTION When disposing of the packaging material, be sure to observe the applicable waste control Before use, verify whether the packages are intact, especially the packages of single use accessories. Make sure that the equipment operating environment meets the specific requirements. Otherwise Avoid rough handling during transport. unexpected consequences, e.g. damage to the equipment, could result. In case of any damage, do not apply it to the patient. Put the equipment in a location where it can be easily viewed and operated. NOTE Keep this manual in the vicinity of the equipment so that it can be referenced when needed. Save the packing case and packaging material as they can be used if the equipment must be reshipped. Many settings in the patient monitor are password protected. It is recommended to change the default passwords and keep the passwords safe. Passwords should only be changed by authorized personnel. Contact the department manager or biomedical engineering department for the passwords used at the facility. 3.2 Monitor Installation The monitor can be installed in various ways as required. Wall mount Placed on desk Trolley tray Bedrail clamp Bedrail hook 3 - 1 3.2.1 Unpacking and Checking Before unpacking, examine the packaging carefully for signs of damage. If any damage is detected, contact the carrier, distributor, or Mindray. If the packing case is intact, open the package and remove the equipment and accessories carefully. Check all materials against the packing list and check for any mechanical damage. Contact Mindray in case of any problems. 3.2.2 Environmental Requirements The operating environment of the equipment must meet the requirements specified in this manual. The environment where the equipment is used shall be reasonably free from noises, vibration, dust, corrosive, flammable and explosive substances. Moreover, to maintain good ventilation, the equipment shall be at least 2 inches (5cm) away from the walls of the cabinet. When the equipment is moved from one place to another, condensation may occur as a result of temperature or humidity difference. In this case, never start the system before the condensation evaporates. Setting Up the Equipment Observance of this manual is a prerequisite for proper product performance and correct operation. It ensures patient and operator safety. Connecting the AC Mains The monitor is powered by an AC power supply. Before connecting the equipment to the AC mains, check that the voltage and frequency ratings of the power line are the same as those indicated besides the AC power input. 3.3 3.3.1 To use the AC power source, follow this procedure:
1. 2. 3. Connect the female end of the power cord with the AC power input. Connect the male end of the power cord with a wall AC outlet. Check that the AC indicator is on. The AC indicator is off if the AC mains is not connected. When AC mains is connected, the AC indicator is illuminated in green. WARNING Operate the equipment on battery power if the integrity of the protective earth conductor or the protective earthing system in the installation is in doubt. CAUTION Always use the accompanying power cord delivered with the monitor. Before connecting the equipment to the AC mains, ensure that the voltage and frequency ratings of the power line are the same as those indicated besides the AC power input. NOTE Use the cable retainer to secure the power cord to prevent it from falling off. 3 - 2 3.3.2 Connecting the Input Devices Connect the barcode reader to the USB port if necessary. 3.3.3 Connecting the Parameter Module To connect the parameter module, follow this procedure:
1. Push the module rack door open, and then push it until you hear a click. 2. With the module properly oriented, align the module insertion guide slot with the module rack insertion guide. Push the module into the module rack until you hear a click. Push the lock at the bottom of the module inwards to lock the module. 3. 3.3.4 Removing the Parameter Module To remove the parameter module, follow this procedure:
1. 2. Pull outwards the lock at the bottom of the module to release the module. Lift the latches at the bottom of the module and slide the module out of the module rack. Hold on the module to make sure it does not drop when it comes out. 3 - 3 CAUTION When removing the module, be careful not to drop it. Always support with one hand while pulling out with the other. 3.4 Turning on the Monitor Before beginning measurements, turn on the monitor. Perform the following inspections:
1. 2. Check the monitor and modules for any mechanical damage. Make sure that all external cables, plug-ins and accessories are properly connected. Connect the power cord to the AC power source. Pressing the power switch turns on the monitor. CAUTION Check that visual and auditory alarm signals are presented correctly when the equipment is Do not use the monitor on a patient if you suspect it is not working properly, or if it is mechanically powered on. damaged. Contact the service personnel or Mindray. 3.5 Operation and Navigation Everything needed to operate the monitor is on its screen. Almost every element on the screen is interactive. Screen elements include parameter values, waveforms, quick keys, information fields, alarms fields, dialogs, and menus. Often you can access the same element in different ways. For example, you can access a parameter dialog by selecting the corresponding numeric area or waveform area, through the Menu hard key parameter module, or through the Parameter Setup quick key. on the 3.5.1 Using the Touchscreen You can use the touchscreen to select a screen element by pressing directly on the monitors screen. To avoid accidental use, you can temporarily disable the touchscreen by holding and pressing the Main Menu quick key and sliding as directed by the arrow. A padlock symbol key if the touchscreen is disabled. displays at the top of the main menu quick The touchscreen lock period is configurable. To do so, follow this procedure:
1. 2. Access Display in either of the following ways:
Select the Screen Setup quick key select the Display tab. Select the Main Menu quick key from the Display column select Display. Set Screen Lock Duration. The touchscreen is enabled when the preset time is reached. To manually enable the touchsceen, hold and press the Main Menu quick key and slide as directed by the arrow. CAUTION Check that the touchscreen is not damaged.broken, or loose. If there is any sign of damage, stop using the monitor and contact the service personnel. 3.5.2 Using the On-Screen Keyboard The on-screen keyboard enables information entry:
Enter the information by selecting one character after another. Select the Backspace key Select the Caps Lock key to delete single characters or select to access uppercase letters. to delete the entire entry. 3 - 4 Select the Enter key to confirm the entry and close the on-screen keyboard. 3.5.3 Using the Barcode Reader The monitor supports both a linear (1D) barcode reader and two-dimensional (2D) barcode reader. The barcode reader is connected to the monitors USB connector. If you are using the Mindray custom 2D barcode reader (Model HS-1R or HS-1M), before using the it for the first time, clear old data formats and configure the barcode reader. NOTE The Mindray custom barcode reader can scan both 2D and 1D barcodes. Other barcode readers can only output the patients medical record number (MRN) and visit number. 3.5.3.1 Clearing Old Data Formats (for the Mindray Custom 2D Barcode Reader) Before using the Mindray custom barcode reader for the first time, clear old data formats. To do so, follow this procedure:
1. 2. Scan the following engineering barcode to clear the previous data format. Scan the 2D engineering barcode which contains the hospitals data format. NOTE Contact the scanner manufacturer or Mindray for obtaining the engineer barcodes for clearing data formats and programming the hospitals data format. 3.5.4 Using the Remote Controller The remote controller can control the monitor by connecting the receiver of the remote controller to the monitors USB connector. For more information on how to use the remote controller, see the Instructions for Use delivered with the remote controller. 3.6 Screen Display The following figure shows the normal screen:
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(9) Patient information area: displays patient information, including patient category, gender, department, room number, bed number, and so on. The displayed patient information is configurable. Selecting this area enters the Patient Management menu. For more information, see 5.3Managing Patient Information. The current configuration Technical alarm information area: displays prompt messages on the above; displays technical alarm messages at the bottom. Physiological alarm information area: displays high priority physiological alarms on the above; displays medium and low priority physiological alarms at the bottom. System status information area: displays alarm symbol, battery status, network status, currently connected CMS, storage device status, and system time. For more information, see 3.6.1On-screen Symbols. Parameter numerics area: displays parameter values, alarm limits, and alarm status. This area also displays parameter list. Selecting a parameter numeric block enters corresponding parameter menu. Selecting the parameter list enters tabular trend review. For more information, see 3.9.3Displaying the Parameter List. Quick key area: displays selected quick keys. Parameter waveform/numerics area: displays parameter waveforms, parameter values, alarm limits, and alarm status. This area also displays parameter list. Selecting a parameter numeric area or waveform area enters corresponding parameter menu. Selecting the parameter list enters tabular trend review. For more information, see 3.9.3Displaying the Parameter List. Parameter waveform area: displays parameter waveforms and parameter alarms. Select a waveform enters corresponding parameter menu. For more information, see 3.9.3Displaying the Parameter List. 3.6.1 On-screen Symbols The following table lists the on-screen symbols displayed on the system status information area:
Symbol Description Symbol Description Adult, male Adult, female Pediatric, male Pediatric, female Neonate, male Neonate, female Wireless network is connected. The solid part indicates network signal strength. Wireless network is not connected. Wired network is connected. Wired network is not connected. All the alarms are paused. Individual physiological alarms are turned off or the monitor is in the alarm off status. Audible alarm tones are paused. Audible alarm tones are turned off. 3 - 6 Symbol Description Symbol Description Alarms are acknowledged and the alarm system is reset. The battery is working correctly. The green portion represents the remaining charge. The battery has low power and needs to be charged. The battery has critically low charge and needs to be charged immediately. Otherwise, the monitor will soon automatically shut down soon. The battery is being charged. No battery is installed. 3.6.2 Dialogs All dialogs have similar style and structure, see the figure below:
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(6) Dialog heading Tabs Operation buttons Exit button: closes the current dialog. Main body area: includes dialog items and options. Switch:
Green: the switch is on. Gray: the switch is off. 3.6.3 Quick Keys The monitor provides quick keys to allow quick access to some functions. The quick key area is located at the bottom of the screen. The Main Menu key is permanently located the right, and the More key is permanently located at the left. Selecting the More quick key shows more quick keys. The quick keys displayed on the screen are configurable. 3 - 7 3.6.3.1 Available Quick Keys The following table shows available quick keys. Symbol Label Function Symbol Label Function Main Menu Enters the main menu. More Shows more quick keys. Alarm Setup Enters the Alarm dialog. Alarm Reset Acknowledges ongoing alarms and reset the alarm system. Audio Pause Pauses alarm tone. Discharge Patient Enters the Discharge Patient dialog. Review Enters the Review dialog. Standby Enters Standby mode. Patient Management Enters the Patient Management dialog. Screen Setup Enters the Screen Setup dialog. NIBP Start/
Stop NIBP STAT Starts an NIBP measurement or stops the current NIBP measurement. Starts a five-minute continuous NIBP measurement. Stop All Stops all NIBP measurements. NIBP Measure Enters the NIBP Measure dialog. Zero IBP Enters the Zero IBP dialog. C.O. Measure PAWP Enters the PAWP screen. Venipuncture Opens the C.O. Measure screen. Inflates the NIBP cuff to help venous puncture. Parameters Setup Enters the Parameters Setup dialog. Remote View Opens the Remote View screen. Manual Event Manually triggers and saves an event. Minitrends Enters the Minitrends screen. OxyCRG Opens the OxyCRG screen. ECG Full-
Screen Enters the ECG full screen. Privacy Mode Enters Privacy mode. Night Mode Enters Night mode. Intubation Mode Enters the intubation mode. Unit Enters the Unit dialog. 3 - 8 Symbol Label Function Symbol Label Function Volume Enters the Volume dialog. Freeze Freezes waveforms. Calculations Enters the Calculations dialog. Load Config Enters the Load Config dialog. Print Starts printing a real-time report. Record Starts/Stops a recording. ECG Lead/Gain Enters the ECG Lead/Gain dialog. Call Help Sends the Call Help signal over the network. GCS Enters the GCS dialog. EWS Enters the EWS screen. Discharged Patients Enters the Discharged Patients dialog. ECG 24h Sum Views the 24-hour ECG summary. CPB Mode Enters the CPB mode. Integrated Devices Enters the Integrated Device screen 3.6.3.2 Configuring the Displayed Quick Keys To select the quick keys for display, follow this procedure:
1. 2. 3. Access Quick Key in either of the following ways:
Select the Screen Setup quick key the Select Quick Keys tab. Select the Main Menu quick key from the Display column select Quick Keys. Select the Current tab to configure the quick keys for display on the screen: From the top of this page, select a block location to show a certain quick key, and then select the quick key from the quick key list. For example, to show the Screen Setup quick key at the first block, select the first block, and then select Screen Setup from the list. Select the More tab to configure the quick keys for display when the More quick key is selected. Operating Modes The monitor provides different operating modes. This section describes the different monitoring modes and standby modes. Monitoring Mode Monitoring mode is the most frequently used clinical mode for patient monitoring. When the monitor is turned on, it automatically enters Monitoring mode. Privacy Mode Privacy mode is a special clinical monitoring mode. In Privacy mode, the monitor does not display patient information and monitoring data. This provides controlled access to patient data and ensures confidentiality. Privacy mode is only available when the patient admitted by the monitor is also monitored by the CMS. The monitor continues monitoring the patient, but patient data is only visible at the CMS. 3.7 3.7.1 3.7.2 3 - 9 3.7.2.1 Entering Privacy Mode To enter Privacy mode, choose either of the following ways:
Select the Privacy Mode quick key select OK. Select the Main Menu quick key from the Display column select Privacy Mode select OK. The monitor has the following features after entering Privacy mode:
The screen turns blank. Except for the low battery alarm, the monitor inactivates alarm tones and alarm lights for all other alarms. The monitor suppresses all system sounds, including heart beat tone, pulse tone, and prompt tone. WARNING
. In Privacy mode, all audible alarms are suppressed and the alarm light is deactivated at the monitor. Alarms are presented only at the CMS. Pay attention to potential risk. NOTE Privacy mode is not available if the Department is set to OR. You cannot enter Privacy mode if a low battery alarm is active. 3.7.2.2 Exiting Privacy Mode The monitor automatically exit Privacy mode in any of the following situations:
The monitor disconnects from the CMS. The low battery alarm occurs. You can also operate the touchscreen, mouse, or keyboard to manually exit Privacy mode. 3.7.3 Night Mode Night mode is a special clinical monitoring mode used to avoid disturbing the patient. Night mode reduces screen brightness, sound volumes, and pauses NIBP measurements. 3.7.3.1 Entering Night Mode To enter Night mode, follow this procedure:
1. 2. 3. Select the Night Mode quick key, or select the Main Menu quick key from the Display column select Night Mode. Change Night mode settings if necessary. Select Enter Night Mode. Night mode settings are as follows by default:
Brightness: 1 Alarm Volume: 2 QRS Volume: 1 Key Volume: 0 NIBP End Tone: Off Stop NIBP: Off CAUTION Verify Night mode settings before entering Night mode. Pay attention to the potential risk if the setting value is low. 3 - 10 3.7.3.2 Exiting Night Mode To cancel Night mode, follow this procedure:
1. 2. Select the Night Mode quick key, or select the Main Menu quick key from the Display column select Exit Night Mode. Select OK. NOTE If the monitor is connected to the CMS, it automatically exits Night mode when being disconnected from the CMS. The monitor resume the previous settings after exiting Night mode. Standby Mode Standby mode can Temporarily stop patient monitoring without switching off the monitor. Entering Standby Mode 1. Select the Standby quick key, or select the Main Menu quick key from the Patient Management column select Standby. Set Location to define where the patient is when the monitor enters Standby mode. Select OK. 2. 3. 3.7.4 3.7.4.1 The monitor behaves as follows after entering Standby mode:
Stops all parameter measurements. Disables all the alarms and prompt messages, except for the battery low alarm. Turns screen brightness to the dimmest after entering Standby mode for 30 seconds. WARNING Pay attention to the potential risk of placing the monitor to standby. In Standby mode, the monitor stops all parameter measurements and disable all the alarm indications, except for the battery low alarm. 3.7.4.2 3.7.4.3 Changing the Patient Location at Standby To change the patients location, select Location from the Standby screen. Exiting Standby Mode To exit Standby mode, choose any of the following ways:
Select Resume Monitor to exit Standby mode and resume monitoring the current patient. Select Discharge Patient to discharge the current patient. Select New Patient to exit Standby mode and admit a new patient. If the monitor automatically enters Standby mode after a patient is discharged, choose any of the following ways to exit Standby mode:
Select New Patient to exit Standby mode and admit a new patient. Select Pre-admit to enter the patient information for preparing to admit a new patient. 3.7.5 Discharge Mode Discharge mode is a special Standby mode after a patient is discharged. 3 - 11 3.8 3.8.1 Configuring the Monitor Configure the monitor before putting it in use. Setting the Date and Time To set the system time, follow this procedure:
1. 2. 3. 4. 5. Select the Main Menu quick key from the System column select Time. Set Date and Time. Set Date Format. Switch off 24 Hour Time to use the 12-hour mode. Switch on Daylight Savings Time to use daylight savings time. You can manually switch on or off the daylight saving time only when the auto daylight savings time function is disabled. For more information, see 3.8.2Adjusting the Screen Brightness for details. If the monitor is connected to a central monitoring system (CMS) or hospital clinical system (HIS), the date and time are automatically taken from the CMS. In this case, you cannot change the date and time on the monitor. CAUTION Changing the date and time affects the storage of trends and events and may result in loss of data. 3.8.2 Adjusting the Screen Brightness The brightness of the primary screen and secondary screen can be adjusted separately. To adjust the screen brightness, follow this procedure:
1. 2. Access Display in either of the following ways:
Select the Screen Setup quick key select the Display tab. Select the Main Menu quick key from the Display column select Display. Set Brightness for the corresponding display. NOTE Screen brightness automatically changes with ambient light level when Brightness is set to Auto. 3.8.3 Adjusting the Volume Set Alarm Volume in either of the following ways:
Select the Volume quick key. Select the Main Menu quick key from the Alarm column select Setup. Set Reminder Volume by selecting the Main Menu quick key from the Alarm column select Setup. Set QRS Volume in any of the following ways:
Select the Volume quick key. From the ECG dialog select Setup. From the SpO2 dialog select PR Setup. Select the Volume quick key to set Key Volume. 3 - 12 3.9 3.9.1 General Operation This section describes the operations that are generally used when monitoring a patient. Switching On or Off a Parameter You can also manually switch on or off a parameter when its module is connected. If setting parameter switches is not password protected, follow this procedure to set parameter switches:
1. 2. Access Parameters On/Off in either of the following ways:
Select the Screen Setup quick key select the Parameters On/Off tab. Select the Main Menu quick key from the Parameters column select Parameters On/Off. Enable or disable desired parameters. When a parameter is switched off, the monitor stops data acquisition and alarming for this measurement. NOTE When a parameter is manually switched off and the corresponding parameter module is plugged in, you cannot monitor this parameter. 3.9.2 Displaying Parameter Numerics and Waveforms Configure the parameter numerics, waveforms, and their sequence displayed on the normal screen by following this procedure:
1. 2. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select the Main Menu quick key from the Display column select Tile Layout. Select a parameter numeric area or waveform area, and then from the popup list select an element to display in this area. The parameters and waveforms not selected will not displayed. If you are using the independent secondary display, you can select parameter and waveform locations on the secondary display. NOTE ECG parameters and waveform are always displayed on the first line of the parameter numeric area and waveform area. 3.9.3 Displaying the Parameter List You can display trends of HR, SpO2, RR, and NIBP/IBP in the parameter numerics area. To do so, follow this procedure:
1. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select the Main Menu quick key from the Display column select Tile Layout. Select the parameter numerics area where you want to display the parameter list, and then from the popup list select Parameter List. 3.9.4 Accessing Parameter Setup Dialogs Each parameter has a setup dialog to allow adjusting the alarm and parameter settings. Enter a parameter setup dialog by using any of the following methods:
Select the parameter numeric area or waveform area. Press the setup hard key Select the Parameter Setup quick key, and then select the desired parameter. on the module front. 3 - 13 Select the Main Menu quick key from the Parameters column select Setup select the desired parameter. NOTE In this manual, the first method is normally used to enter the setup dialog. But you can use any method you prefer. 3.9.5 Changing Measurement Colors Set the color of measurement values and waveforms for each parameter by following this procedure:
1. 2. 3. Select Main Menu quick key from the Parameters column select Parameter Color. Select the Current tab and set the colors of the currently monitoring measurement values and waveforms. Select the All tab and set the colors of measurement values and waveforms for all parameters. 3.10 Freezing Waveforms During patient monitoring, the freeze feature allows you to freeze the currently displayed waveforms on the screen so that you can have a close examination of the patients status. Additionally, you can select any frozen waveform for recording. 3.10.1 Freezing Waveforms To freeze waveforms, select the Freeze quick key. Except waveforms of the following screens, all displayed waveforms stop refreshing and scrolling after you select the Freeze quick key:
Minitrends screen OxyCRG screen Remote View screen EWS screen 3.10.2 Viewing Frozen Waveforms To view the frozen waveforms, follow this procedure:
Select the Slide the frozen waveform leftward or rightward. button in the Freeze screen. or At the lower right corner of the bottom-most waveform displays the freeze time. The initial frozen time is 0 s. With the waveforms scrolling, the freeze time changes at an interval of 1 second. For example, -2 s means two seconds before the frozen time. This change will be applied for all waveforms on the screen. NOTE You can view the frozen waveforms of up to 120 seconds. 3.10.3 Unfreezing Waveforms To unfreeze the frozen waveforms, select the Numerics. 3.10.4 Printing Frozen Waveforms To print the frozen waveforms, select the button at the upper right corner of the Freeze Big button at the upper left corner of the Freeze Big Numerics. 3 - 14 3.11 Checking Software Licenses To run the following functions in the monitor, software licenses are required:
Early Warning Score (EWS) ECG 24H Summary To check the licenses, select the Main Menu quick key select License Local. To install the licenses, follow this procedure:
1. 2. 3. Connect the USB drive with the licenses in to the monitors USB connector. Select the Main Menu quick key select License select External. Select Install. 3.12 Capturing the Screen The monitor provides the function of screen capture. To capture the current screen display, follow this procedure:
1. 2. Connect the USB drive to the monitors USB connector. Press and hold the More quick key. Wait until it turns from blue to grey. The captured pictures are automatically saved in the USB drive. 3.13 Connecting the CMS You can connect the monitor to the BeneVision CMS through wired LAN or wireless LAN. When connected to the CMS, the system provides the following function. The monitor can transmit parameter values, waveforms, alarms, and events to the CMS. From the CMS, you can check the patients monitoring data and alarms. The monitor can transmit parameter values and alarms from the connected external devices to the CMS. From the CMS you can check the patients monitoring data and alarms obtained from the connected external devices. Patient information, alarm settings, and alarm status can be synchronized between the monitor and the CMS. You can start or stop NIBP measurements from the CMS. In case of network disconnection, the monitor can transmit the offline data to the CMS when the network is reconnected. For more information on the CMS, see BeneVision Central Monitoring System Operator's Manual (PN: 046-010879-
00). To select a CMS, select the system status information area at the top right corner of the main screen. Select the desired CMS from the popup CMS list. NOTE You can select CMS only when the Select CMS switch is on. For more information, see 25.12.7Enabling Selecting a CMS. 3.14 Connecting the eGateway You can connect the monitor to the eGateway through wired LAN or wireless LAN to implement interaction between the monitor and external devices. When connected to the eGateway, the system provides the following functions:
The monitor can transmit parameter values, waveforms, alarm settings, and events to the eGateway. The monitor can transmit parameter values and alarm settings received from the BeneLink-connected external devices to the eGateway. Clock can be synchronized between the monitor and the eGateway. 3 - 15 3.15 Disconnecting the Wireless Network To disconnect the wireless network manually, follow this procedure:
1. 2. Swipe the screen from top down with a single finger. Select
. To reconnect the wireless network after it is disconnected manually, follow this procedure:
1. 2. Swipe the screen from top down with a single finger. Select
. 3.16 Turning Off the Monitor Before turning off the monitor, perform the following check:
1. 2. 3. Ensure that patient monitoring has been completed. Disconnect the cables and sensors from the patient. Save or clear the patient data as required. To turn off the monitor, press and hold the power switch for 3 seconds. Turning off the monitor does not disconnect the monitor from the AC mains. To completely disconnect the power supply, unplug the power cord. CAUTION Press and hold the power switch for 10 to forcibly shut down the monitor if it could not be shut down normally. This may cause loss of patient data. NOTE If a monitor is on during a power loss, then the monitor is automatically switched on when the power is restored. In case of a temporary power failure, if the power is restored within 30 minutes, monitoring will resume with all active settings unchanged. If the monitor is without power for more than 30 minutes, it behaves the same as if it were normally turned off. 3 - 16 4 User Screens The monitor provides different user screens to facilitate patient monitoring in different departments and clinical applications. 4.1 Choosing a Screen The monitor enters the normal screen after it is powered on. The normal screen is most frequently used for patient monitoring. To select other screens, follow this procedure:
1. 2. Access the Choose screen tab in either of the following ways:
Select the Screen Setup quick key. Select the Main Menu quick key from the Display column select Choose screen. Select the desired screen. 4.2 Normal Screen The normal screen is most frequently used for patient monitoring. For general department, ICU, and CCU, normal screen is used by default. 4.2.1 Entering the Normal Screen To enter the normal screen, choose any of the following ways:
Swipe left or right on the touchscreen with two fingers to switch to the normal screen. Select the Screen Setup quick key select the Choose Screen tab select Normal Screen. Select the Main Menu quick key from the Display column select Choose Screen select Normal Screen. 4.2.2 Configuring the Normal Screen You can configure the parameter numerics, waveforms, and their sequence displayed on the normal screen. To do so, follow this procedure:
1. 2. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key. Select the Main Menu quick key from the Display column select Tile Layout. Select a parameter numeric area or waveform area, and then from the popup list select an element you want to display in this area. The parameters and waveforms you did not select will not displayed. NOTE ECG parameters and waveform are always displayed on the first line of the parameter numeric area and waveform area. 4 - 1 4.3 The Big Numerics Screen The Big Numerics screen displays parameter numerics in big font size. The Big Numerics screen displays measurement values and waveforms of up to six parameters. You can configure the parameters and their layout on the big numeric screen. 4.3.1 Entering the Big Numerics Screen To enter the big numerics screen, choose any of the following ways:
Swipe left or right on the touchscreen with two fingers to switch to the big numerics screen. Select the Screen Setup quick key select the Choose Screen tab select big numerics Screen. Select the Main Menu quick key from the Display column select Choose Screen select big numerics Screen. 4.3.2 Configuring the Big Numerics Screen To configure the big numerics screen, follow this procedure:
1. 2. 3. Access Choose screen in either of the following ways:
Select the Screen Setup quick key . Select the Main Menu quick key from the Display column select Choose screen. Select the Big Numerics tab Select a parameter numeric area or waveform area, and then from the popup list select an element to display in this area. 4.4 4.4.1 Minitrends Screen The Minitrends screen shows the recent graphic trends of parameters. Entering the Minitrends Screen Choose one of the following methods to enter the Minitrends screen:
Select the Minitrends quick key. Select the Screen Setup quick key Select the Choose Screen tab select Minitrends. Select the Main Menu quick key from the Display column select Choose Screen select Minitrends. 4 - 2 4.4.2 The Display of Minitrends Screen The following figure shows the minitrends screen. Your display may be configured to look slightly different.
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(2) Scale Routine Vital/Baseline button. If the department is set to OR, then the Baseline button is available. For other departments, the Routine Vital button is available. Routine Vital/Baseline Select this button to view the trends of longer time Time line Alarm statistic area Aldrete Score button. This button is available for the OR department.
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(7) 4.4.3 Viewing Trends of Longer Time To view the trends of longer time, follow this procedure:
1. 2. Enter the Minitrends screen. Select button from the Minitrends screen, or swipe right on the screen with a finger. 4.4.4 Setting Minitrends Parameters To set parameters, follow this procedure:
1. 2. 3. Enter the Minitrends screen. Select the Setup button. Set parameters. If you want to use the default parameters, select Default Parameter. 4 - 3 4.4.5 Setting the Minitrend Length To set the Minitrend length, follow this procedure:
1. 2. 3. Enter the Minitrends screen. Select the Setup button. Set the Minitrend Length. 4.4.6 Setting the Alarm Statistics Switch The Minitrends screen can be configured to display the statistic number of physiological alarm in its lower half screen. To set the alarm statistics switch, follow this procedure:
1. 2. 3. Enter the Minitrends screen. Select the Setup button. Switch on or off the Alarm Statistics switch. 4.4.7 Setting the Alarm Statistics Length The time length within which the alarms statistics are made is configurable. To set the alarm statistics length, follow this procedure:
1. 2. 3. Enter the Minitrends screen. Select the Setup button. Set Alarm Statistics Duration. 4.4.8 Routine Vital/Baseline The Routine Vital/Baseline function is used for marking the parameter measurements of certain moment for later reference. If the department is set to OR, then the Baseline button is available. For other departments, the Routine Vital button is available. 4.4.8.1 Manually Marking the Routine Vital/Baseline To manually mark the Routine Vital/Baseline, follow this procedure:
1. 2. Enter the Minitrends screen. Select the Routine Vital button or Baseline button. NOTE If you do not see the Baseline button or Routine Vital button in the Minitrends screen, you can select the Setup button and switch on the Baseline switch, or set the Routine Vital to Manual or Auto. 4.4.8.2 Configuring Automatic Routine Vital Settings The monitor can automatically mark the routine vital sign values. To enable this function, follow this procedure:
1. 2. 3. 4. 5. Enter the Minitrends screen. Select the Setup button. Select Auto from the dropdown list of Routine Vital. Select Time to set the time for marking the first routine vital sign values. Select Interval to set the interval for marking the routine vital sign values. 4 - 4 4.4.9 Aldrete Score Select Aldrete Score to show the latest score and scoring time. To understand the current patient status, select a score for each item and then select OK to get a new score. WARNING The Aldrete score and recommendation is for reference only. Clinicians must make the decision of discharging the patient from recovery according to the patients actual condition. 4.5 The OxyCRG Screen The OxyCRG screen is the default user screen when the neonatology department is selected. It displays 6-minute HR/btbHR, SpO2 trends, CO2/Resp compressed waveform, ABD parameters, and the latest ABD events. The OxyCRG function is intended for neonatal patents only. 4.5.1 Entering the OxyCRG Screen To enter the OxyCRG screen, choose any of the following ways:
Swipe left or right on the touchscreen with two fingers to switch to the OxyCRG screen. Select the OxyCRG quick key. Select the Screen Setup quick key select the Choose Screen tab select OxyCRG. Select the Main Menu quick key from the Display column select Choose Screen select OxyCRG. 4.5.2 OxyCRG Events The following table lists the ABD events and their criteria:
Event type Description A B D BD AB AD ABD Apnea event: the apnea duration exceeds the threshold. A20: the apnea duration is greater or equal to 20 seconds. A15: the apnea duration is between 15 to 20 seconds (excluding 20 seconds). A10: the apnea duration is between 10 to 15 seconds (excluding 15 seconds). Bradycardia event: the duration of low heart rate, bradycardia, extreme bradycardia, or asystole exceeds the threshold. Low SpO2 event: the duration of SpO2 Desat exceeds the threshold. Bradycardia and low SpO2 happen at the same time. Apnea and bradycardia happens at the same time. Bradycardia and low SpO2 happen at the same time. Apnea, bradycardia, and low SpO2 happen at the same time. Remarks A20 is a red event
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Red event Red event Red event NOTE The monitor records all ABD events for OxyCRG review, but only red events displays in the ABD list of the OxyCRG screen. 4.5.3 The Display of the ABD Event Area The ABD event area displays parameter values of currently active OxyCRG events and lists the latest red ABD events. 4 - 5 4.5.4 4.5.5 Setting OxyCRG Parameters Select parameter trends or compressed waveform to set parameters and the compressed waveform you want to display. The selected parameters will be used for ABD event calculation. Setting the Threshold of ABD Events Select any parameter trend or the compressed waveform to perform the following setup:
Set the threshold of ABD events. Set Event Storage Format:
1 min+3 min: stores data one minute before and three minutes after the event. 3 min+1 min: stores data three minutes before and one minute after the event. 2 min+2 min: stores data two minutes before and two minutes after the event. The stored data includes the trends of the OxyCRG parameters, compressed waveform, alarm thresholds, NIBP, and Temp measurements. 4.5.6 Editing ABD Events To edit ABD events, follow this procedure:
1. 2. 3. 4. Select the Mark button to enter the Mark dialog box. Drag the event list upwards and downwards to select the desired event. Select the patients status when the event happens. Select Save. The SpO2 Screen For neonatal patients, if you are only concerned with the patients SpO2 and pulse rate, you can use the SpO2 screen. The SpO2 screen displays SpO2 related data. It also displays realtime Temp and NIBP measurements. NOTE The SpO2 screen is intended for neonatal patient only. Entering the SpO2 Screen To enter the SpO2 screen, choose any of the following ways:
Swipe left or right on the touchscreen with two fingers to switch to the SpO2 screen. Select the Screen Setup quick key select the Choose Screen tab select SpO2 Screen. Select the Main Menu quick key from the Display column select Choose Screen select SpO2 Screen. 4.6 4.6.1 4 - 6 4.6.2 The Display of SpO2 Screen The following figure shows the SpO2 screen. Your display may be configured to look slightly different.
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(6) Tabular trend: displays trends of SpO2, PR, and PI. SpO2 statistics area: displays the statistics data of each SpO2 section. Temp area: displays Temp measurements and alarm limits. NIBP area: displays NIBP measurements and alarm limits. SpO2 area: displays measurements and alarm limits of PR, and PI. The dashboards show information of alarm limits. The pointers indicate the current measurement values. The Pleth waveform 4.6.3 Operating the SpO2 Screen You can access parameter setup and trends review from the SpO2 screen. To do so, follow this procedure:
Select the trend of SpO2, PR, or PI to enter the Tabular Trends review page. Select the SpO2 statistics area to enter the SpO2 Statistics Setup dialog. Set the range of each SpO2 section and the target section. Select the value of SpO2, PR, or PI, the dashboard, or Pleth waveform to enter the SpO2 dialog. Select the Temp area to enter the Temp dialog. Select the NIBP area to enter the NIBP dialog. 4.7 Remote View On the monitor, you can observe alarm conditions and view real time physiological data from patients on other compatible remote networked monitoring devices, such as a bedside monitor or a telemetry device. A device from a remote site is called a remote device or bed. The monitor can simultaneously watch up to 12 remote devices. They all can show waveforms of one remote device. You can watch the remote devices in the Remote View screen, or the alarm watch tiles on the main screen. In the Remote View screen, you can view real time parameters and waveforms from one specific device, and watch the alarms of other monitored devices at the same time. NOTE A particular monitor (for example Monitor 1) can be viewed by at most 32 remote devices at the same time, of which eight of those remote devices can watch Monitor 1s waveforms. 4 - 7 4.7.1 Entering the Remote View Screen To enter the Remote View screen, choose one of the following ways:
Select the Remote View quick key. Select the bed at the alarm watch tile on the main screen. For more information, see 4.7.10.2Displaying the Alarm Watch Tile on the Main Screen. Select the Screen Setup quick key select the Primary Display tab or Secondary Display tab (as available) select the Choose Screen tab select Remote View. 4.7.2 About the Remote View The following figure shows the Remote View window.
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(1) Alarm watch area Display all the monitored remote beds. Each bed displays the room number, bed number, connection status and alarm status. The background color indicates the alarm status on the corresponding bed. Background Color Description Green Red Yellow Cyan Grey
(2) Main body No alarm is occurring to the bed. The remote device is disconnected or a high priority alarm is occurring. The high priority alarm currently is the highest alarm level on the bed. If the remote device is disconnected, the icon is displayed. The medium priority alarm is occurring. The medium priority alarm currently is the highest alarm level on the bed. The low priority alarm is occurring. The low priority alarm currently is the highest alarm level on the bed. The bed is in the standby mode. Display the patients information, alarm status and messages, waveforms, measurements, etc. of the selected bed. This bed is called main bed. 4 - 8 WARNING The data presented in the Remote View screen has a delay. Do not rely on this screen for real time data. 4.7.3 Adding a Bed After adding the desired remote devices, then the alarms from these devices can be viewed on the monitor. To add a remote device, follow this procedure:
1. 2. 3. Enter the Select Bed dialog. To do so, choose either of the following ways:
In the Remote View screen, select Select Bed. For more information, see 4.7.1Entering the Remote icon at the alarm watch tile if the tile is configured to display on the main screen. View Screen. Select the In the Select Bed dialog, select a desired department. All the beds under this department will be listed. Select a desired tile at the A-W1or A-W2 area and then select a bed from the bed list. The selected bed will appear in the tile. NOTE The added bed is indicated by a check mark () at the right of the bed list. 4.7.4 Removing a Bed To remove a remote device from remote monitoring, follow this procedure:
1. 2. Enter the Select Bed dialog. Choose either of the following ways:
In the Remote View screen, select Select Bed. For more information, see 4.7.1Entering the Remote View Screen. Select the In the Select Bed dialog, select a bed at the A-W1or A-W2 area, and then select Clear Bed. If you want remove all beds, select Clear All Beds. icon in the alarm watch tile if the tile is configured to display on the main screen. 4.7.5 4.7.6 4.7.7 Displaying the Main Bed In the Remote View screen, you can select a bed in the alarm watch area, then the main body of the Remote View screen will display the real time monitoring screen of the device. Saving a Manual Event You can initiate a manual event on the remote monitor by selecting Manual Event in the Remote View screen. Managing Alarms from Remote Devices You can view and manage the alarms coming from remote devices. If the monitor and remote devices have alarms at the same time, the monitor presents alarms according to the following rules:
If the alarm tone pattern for the monitor is same as that for the remote devices, the monitor prioritizes all the alarms and sounds the highest alarm tone. If the alarm tone pattern for the monitor is different from that for the remote devices, the monitor sounds the alarms in their corresponding tone. The monitor provides the same alarm tone pattern for the remote device alarms as those for the monitor alarms by default. You can change the alarm tone pattern of the remote monitor; see 25.3.5.5Setting the Tone Pattern for Alarms from Remote Devices. 4 - 9 4.7.8 4.7.9 Resetting Alarms for Remote Devices You can reset the alarms on the remote devices by selecting Alarm Reset in the Remote View screen. This function needs to be enabled. For more information, see 25.3.5.1Resetting Alarms for Remote Devices. Selecting Beds By Care Group If configured, the monitor automatically selects beds in the same care group during the shift of care groups in the CMS. To enable this function, follow this procedure:
1. 2. Enter the Select Bed window. Choose either of the following ways:
In the Remote View window, select Select Bed. For more information, see 4.7.1Entering the Remote View Screen for entering the Remote View window. Select the In lower left corner of the Select Bed window, select Select Beds By Care Group. icon in the alarm watch tile if the tile is configured to display on the main screen. 4.7.10 Alarm Watch The alarm watch function provides the alarm notification by color and sound. The monitor sounds the highest priority alarm tone from all the monitored remote devices. The monitor displays the highest priority alarm in corresponding background color for each bed at the following areas:
At the top of the Remote View. For more information, see 4.7.2About the Remote View for details. On the main screen. For more information, see 4.7.10.1About Alarm Watch Tile for details. 4.7.10.1 About Alarm Watch Tile The main screen can display up to three alarm watch tiles, namely A-W1, A-W2 and A-W3. Each tile can accommodate up to six beds. The following figure shows the alarm watch tiles.
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(5) Alarm watch tile label Disconnection icon: when the remote device is disconnected, this icon displays at the tile, and the tile background color is red. Select bed icon: select it to enter the Select Bed window. More than one bed tile: when more than one bed is assigned to a tile, the tile displays the alarm status, connection status, etc. One bed tile: when only one bed is assigned to a tile, the tile displays the parameter value and alarm message from this bed, etc. The alarm watch tile is similar to alarm watch area in the Remote View. For more information, see 4.7.2About the Remote View. 4 - 10 4.7.10.2 Displaying the Alarm Watch Tile on the Main Screen To configure the alarm watch tile to be displayed on the monitors main screen, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Display column select Choose Screen to enter the Screen Setup dialog. Select the Tile Layout tab. Select the numeric area where you want to display the alarm watch tile, and then in the drop-down list, select Alarm Watch A-W1or A-W2. 4 - 11 5 Managing Patients 5.1 Starting Monitoring a Patient After turning on the monitor, follow this procedure to monitor a patient:
1. 2. 3. Admit the patient. Check patient settings. Make sure that alarm limits, patient category and paced status, and so on, are appropriate for the patient. Change them if necessary. Perform desired measurements. For more information, see corresponding measurement chapters. 5.2 Admitting a Patient The monitor admits a new patient in the following situations:
After a patient is manually discharged, the monitor automatically admits a new patient. After being switched off for the selected time period, the monitor automatically discharges the previous patient and admits a new patient at startup. If the monitor has not detected certain patient vital signs (ECG, SpO2, PR, RR, NIBP) for 30 minutes, it will prompt whether to start monitoring a new patient if any of the above vital signs are detected again. Always input patient information as soon as the patient is admitted. For more information, see5.2.2Editing Patient Information for details. WARNING The default Patient Category setting is Adult, and Paced setting is Unspecified. Set Paced and check if the Patient Category setting is correct for the patient. For paced patients, set Paced to Yes. If it is incorrectly set to No, the monitor could mistake a pace pulse for a QRS and fail to alarm when the ECG signal is too weak. For non-paced patients, set Paced to No. 5.2.1 Entering the Patient Management Dialog Use any of the following methods to enter the Patient Management dialog:
Select the patient information area at the top left corner of the screen. Select the Patient Management quick key. Select the Main Menu quick key from the Patient Management column select Patient Management. 5.2.2 Editing Patient Information Edit patient information after a patient has been admitted, or when patient information is incomplete, or when it is necessary to change patient information:
To edit patient information, follow this procedure:
1. 2. Enter the Patient Management dialog. For more information, see 5.2.1Entering the Patient Management Dialog. Edit patient information as required. If a barcode reader is connected to the monitor, scanning the patients barcode will enter the patients information. 5 - 1 NOTE The monitor will reload the configuration if you changed the patient category. 5.2.3 Loading Patient Information from the CMS If the monitor is connected to the central monitoring system (CMS). You can load patient information from the CMS to the monitor. To do so, follow this procedure:
1. 2. 3. 4. Enter the Find Patient dialog in either of the following ways:
Select the Main Menu quick key from the Patient Management column select Find Patient. From the Patient Management dialog select Find Patient. Input query criteria. Select Search. Then a list pops up, including all the patients that meet the query criteria. Select a patient from the patient list, and then select Admit. Corresponding patient information in the monitor will be updated. NOTE If ADT Query is switched on, input query criteria from the Discharged Patient page. 5.2.4 Loading Patient Information from the ADT Server If the monitor is connected with the Admit-Discharge-Transfer (ADT) server through the eGateway. You can load patient information from ADT server to the monitor. To do so, follow this procedure:
1. 2. 3. 4. Enter the Find Patient dialog in either of the following ways:
Select the Main Menu quick key from the Patient Management column select Find Patient. Select Find Patient from the Patient Management dialog. Input query criteria. Select Search. Then a list pops up, including all the patients that meet the query criteria. Select a patient from the patient list, and then select Admit. Corresponding patient information in the monitor will be updated. NOTE You can load patient information from the ADT server only when ADT Query is enabled. For more information, see 25.12.12Using the ADT Gateway. The monitor can automatically upload the patient information from the ADT server when:
The configured keywords of the monitor and the eGateway are the same. The IP address of the monitor is added to the eGateway configuration dialog. Loading patient information from the ADT server updates only patient information in the monitor. The patients monitoring data is not changed and the patient is not discharged. 5.3 Exporting Patient Data To export the data of the current patient and discharged patients, follow this procedure:
1. 2. Connect the USB drive to the monitors USB connector. Access the Discharged Patients dialog box by either of the following ways:
Select the Discharged Patients quick key. Select the Main Menu quick key from the Patient Management column select Discharged Patients. 3. From the patient list select desired patients. 5 - 2 4. Select Export Data. 5.4 Deleting Patient Data To delete the data of discharged patients, follow this procedure:
1. 2. 3. Access the Discharged Patients dialog box by either of the following ways:
Select the Discharged Patients quick key. Select the Main Menu quick key from the Patient Management column select Discharged Patients. From the patient list select desired patients. Select Delete. 5.5 Stopping a Parameter Measurement To stop monitoring a parameter, follow this procedure:
1. 2. 3. Remove corresponding sensor from the patient. Disconnect the sensor from the patient cable. Disconnect the patient cable from the parameter module. 5.6 Discharging a Patient Before monitoring a new patient, discharge the previous patient. The technical alarms are reset, and monitor settings returns to their defaults. For more information, see 24.3Setting Default Patient Category. After a patient is discharged, the monitor automatically admits a new patient. WARNING Always discharge the previous patient before starting to monitor a new patient. Failure to do so can lead to data being associated with the wrong patient. To manually discharge a patient, use any of the following methods to access the Discharge Patient dialog:
Swipe down the touchscreen with two fingers. Select the Discharge Patient quick key. Select the patient information area at the top left corner of the screen Discharge Patient. Select the Patient Management quick key Discharge Patient. Select the Main Menu quick key from the Patient Management column select Discharge. Select a button in the Discharge Patient dialog:
Print End Case Report: prints the end case report when the patient is discharged. Discharge: clears the waveform data of the current patient. The monitor loads the default configuration and goes to the standby mode. The current patient becomes a discharged patient. Clear Patient Data: discharges the current patient and clears the waveform data. The monitor still uses the current configuration and does not go to the standby mode. The current patient becomes a discharged patient. 5 - 3 6 Interfacing with External Devices 6.1 BeneLink Introduction BeneLink module is intended for connecting external devices, such as ventilators and anesthesia machines, to the monitor. It allows information (patient data, alarms, etc.) from external devices to be displayed, saved, recorded, or printed through the monitor. If the monitor is connected with the CMS or eGateway, information from external devices can also be transmitted to the CMS or eGateway. For more information on connecting external devices via the BeneLink module, see BeneLink Module Operators Manual (PN: 046-011948-00). 6.2 BeneLink Safety Information WARNING Devices of the same category cannot be connected to the BeneLink module simultaneously. The parameter labels used on the patient monitor may be different from those used on the external device. The alarms from external devices may be delayed before transmission to the patient monitor. There can be differences between the alarm priorities displayed on the monitors and the priorities displayed on external devices interfaced through BeneLink. NOTE The alarm messages from external devices are derived from the open protocol of the corresponding external device. For more information about these alarms, please see the operators manual for the corresponding devices. 6 - 1 6.3 Differences in Displayed Values In certain cases, there may be differences between the numerics displayed on the monitor and those on external devices. The table below lists some situations and possible reasons. Situation Possible Reasons Some parameter values are displayed as invalid values on the monitor. The monitor and external device display parameter values with different numbers of places of decimals. The patient monitor and the external device may have different parameter configuration or displaying range of values. If the patient monitor displays a parameter not configured in the external device, or a parameter value from the external device exceeds the displaying range of the monitor, then the corresponding parameter value is displayed on the monitor as an invalid value. The monitor displays parameter values from the external device based on the monitor displaying rules. Same parameter value is displayed differently when the monitor and the external device display numbers with different precision. Non-continuously measured values and continuously measured values have the same displaying mode in the patient monitor. For non-continuously measured values, the monitor displays the latest measured values until a new measurement is transmitted by the external device. Parameter values displayed on the patient monitor and those displayed in the external device are slightly different. Some parameter values are converted to different units when transmitted to the monitor. Sometimes, values from the external device may be delayed before transmission to the patient monitor. NOTE When the pressure units are converted among cmH2O, hPa and mbar, the parameter values remain unchanged, for example, 1cmH2O=1hPa=1mbar, which may differ from some external devices. 6.4 Connecting an External Device An external device is connected to the BeneLink module through an ID adapter. The ID adapter supports only its matching device.
(1)
(3)
(4)
(2)
(5)
(1) BeneLink Module
(3) RJ45 connecting cable
(2) Label
(4) ID Adapter
(5) External device
(6) Serial port adapting cable (optional)
(6) 6 - 2 To connect an external device, follow this procedure:
1. 2. 3. 4. Insert the BeneLink module into the module rack. Connect the ID adapter that matches the external device to the BeneLink module with an RJ45 connecting cable. Plug the ID adapter into the RS232 port on the external device. Some external devices may have ports incompatible with the ID adapter. In this case, a serial port adapting cable is required. Stick a device name label to the RJ45 connecting cable at the end close to the BeneLink module. When the BeneLink module is connected to several external devices, you can tell devices easily with these labels. Switch on the external device. After the external device is connected to the monitor, the indicators on both the ID adapter and the BeneLink module illuminate to show that the monitor successfully communicates with the external device. CAUTION First installation and debugging should be executed by Mindray service personnel or an authorized technician. Please check the compatibility of the external device and the ID adapter before connection. Otherwise, unpredictable system failure may result. Ports on the BeneLink module are not conventional network connectors. They are intended for connecting with the serial port of designated devices only. Do not connect them to network interfaces. 6.5 Accessing the Integrated Devices Screen You can view the information of external devices in the Integrated Devices screen of the monitor. The Integrated Devices screen provides information of both individual device and multi devices. To access the Integrated Devices screen, follow this procedure:
Select the Integrated Device quick key. Select the Screen Setup quick key select Integrated Devices. Select the Main Menu quick key from the Display column select Choose Screen select Integrated Devices. Select the numeric area or waveform area of any parameter from the external device select Integrated Devices button. The Integrated Devices screen has the following features:
For the parameters measured by the external device, the measurements display directly after the parameter labels. For the parameters controlled by the external device, the settings are enclosed in parenthesis after parameter labels. 6 - 3 For the parameters measured and controlled by the external device, measurements and settings are displayed after parameter labels, and settings are also enclosed in parenthesis. For example, PEEP 18 (20), in which PEEP is parameter label, 18 is the measurement, and (20) is the setting. NOTE Parameters in the Integrated Devices screen are displayed in the order as shown in the selection dialog. If the screen cannot display all the selected parameters, only the beginning selected parameters are displayed. 6.6 Displaying Parameters from External Devices This monitor can display parameters from external devices in the main screen:
Display waveforms from external devices in the waveform area. Display labels and measurements of parameters from external devices in the numeric area. Display respiratory loops of parameters from external deivices in the Loops screen. NOTE When displayed in the monitor main screen, parameter labels of external devices are prefixed with the plug sign +. For example, if SpO2 is from an external device, its label is displayed as +SpO2, and its waveform label is displayed as +Pleth. If a parameter can be obtained either from the monitor or an external device, the measured value, waveform or loops coming from the monitor will be displayed preferentially. 6.6.1 Setting Waveform Properties for Parameters from External Devices To set the waveform properties for parameters from external devices, follow this procedure:
1. 2. Access the parameter setup dialog by selecting its waveform area or numeric area. Set Speed or Scale. 6.6.2 Setting Alarms from External Devices To enable or disable the storage, display, and sound of the external device alarms of a certain priority and category, follow this procedure:
1. 2. From the Integrated Devices screen select Setup. Set switches as desired. If the storage, display, or audio settings of a specific alarm are different from its category or priority, set them individually by adding the Alarm ID to the alarm list. To do so, follow this procedure:
1. 2. From the Integrated Devices screen select Setup. Input the Alarm ID for this alarm, and select Add. To delete the special case handling of a specific external device alarm, select the desired Alarm ID, and select Delete. Refer to the BeneLink Module Operators Manual (PN: 046-011948-00) for the list of supported alarms and Alarm IDs. 6.6.3 Setting Parameters from External Devices for Display To select parameters displayed in the Integrated Devices screen, follow this procedure:
1. 2. From the Integrated Devices screen select Select Parameter. Select desired parameters. 6 - 4 In the main screen, the numeric area of some parameters from an external device, for example the +Paw parameter, can display multiple parameters. To select parameters for display, follow this procedure:
1. 2. 3. Select the numeric area of the parameter from the external device. Select the Select Parameter tab. Select the parameters for display. 6.6.4 Setting Units for Parameters from External Devices To set units for parameters from external devices, follow this procedure:
1. 2. 3. Select the numeric area or waveform area of any parameter from the external device. Select the Unit tab. Set the unit for O2, CO2, Pressure or Temp. 6.6.5 Accessing the Loops Screen To access the Loops screen, follow this procedure:
1. 2. Select the numeric area or waveform area of +Paw, +Flow, or +Vol to enter its corresponding setup dialog. Select the Loops button. NOTE The monitor only displays real-time loops of the external device, and these loops cannot be displayed or saved as reference loops. 6.7 6.8 Viewing Alarms from External Devices If the patient monitor is configured to do so, the monitor displays alarms from external devices in the physiological and technical alarm information areas. A plus sign + is added before each alarm message from external devices. Viewing Parameter Trends from External Devices If the patient monitor is configured to do so, the monitor saves parameters trends and alarm events from external devices. You can review these data in the Tabular Trends, Graphic Trends, Events and Full Disclosure pages in the Review screen.The monitor adds a + before the parameter label of external devices. For more information, see 18Review. NOTE Parameters from external devices are saved and displayed according to the time on the monitor. 6.9 Recording and Printing Parameter Trends from External Devices You can record or print parameter trends from external devices. For more information, see 18Review, 21Recording, and 22Printing. 6 - 5 7 Alarms 7.1 Alarm Introduction This chapter describes alarm functions and alarm settings. 7.2 Alarm Safety Information WARNING A potential hazard can exist if different alarm presets and default configuration settings are used for the same or similar equipment in the same care area, for example an intensive care unit or cardiac operating room. If the monitor is connected to the central monitoring system (CMS) or other monitors, alarms can be presented and controlled remotely. Remote suspension, inhibition, or reset of monitor alarms via the CMS or other monitors may cause a potential hazard. For more information, see the operators manuals for the CMS and the other monitors. The monitors in the care area may each have different alarm settings to suit different patients. Always check that the alarm settings are appropriate for the patient before starting the monitoring. Always make sure that necessary alarm limits are active and set according to the patient's clinical condition. Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, setting the SpO2 high alarm limit to 100%, is equivalent to switching the alarm off. When the alarm sound is switched off, the monitor gives no alarm tones even if a new alarm occurs. Be careful when considering to switch off the alarm sound. When the alarms are off or while alarm audio is paused either temporarily or indefinitely, observe the patient frequently. When monitoring patients that are not continuously attended by a clinical operator, properly Do not rely exclusively on the audible alarm system for monitoring. Adjustment of alarm volume to a configure the alarm system and adjust alarm settings as per the patient's condition. low level may result in a hazard to the patient. 7.3 Understanding the Alarms 7.3.1 Alarm Categories The monitor has two different types of alarms: physiological alarms and technical alarms. Physiological alarms are triggered by patient measurement exceeding the parameter limits, or by an abnormal patient conditions. Technical alarms are triggered by an electrical, mechanical, connectivity, or other monitor abnormal operation, or by failure of a sensor or component. Technical alarm conditions may also be caused when an algorithm cannot classify or interpret the available data. Apart from the physiological and technical alarms, the monitor can also prompt with some messages describing the system status or patient status. 7.3.2 Alarm Priorities By severity, the alarms are classified into the following priority levels:
High priority alarms: indicates a life threatening situation or a severe device malfunction. High priority alarms require an immediate response. Medium priority alarms: indicates abnormal vital signs or a device malfunction. Medium priority alarms require a timely response. 7 - 1 Low priority alarms: indicate a discomfort condition, a device malfunction, or an improper operation. Low priority alarms require you to be aware of this condition. Messages: provides additional information on the patient or the equipment. 7.3.3 Alarm Indicators When an alarm occurs, the monitor indicates it through visual or audible alarm indications. For more information, see the following table. Alarm Indicator High Priority Alarm Medium Priority Alarm Low Priority Alarm Message Comments Alarm lamp ISO Audible tone pattern Mode 1 Mode 2 Red Flashing frequency: 1.4 -
2.8 Hz Duty cycle: 20 -
60% on Repeat pattern of triple +
double+ triple +
double beeps Repeat pattern of high-pitched single beep Repeat pattern of high-pitched triple beeps Yellow Flashing frequency: 0.4 -
0.8 Hz Duty cycle: 20 -
60% on Repeat pattern of triple beeps None None Cyan No flashing Duty cycle:
100% on Single beep None None Repeat pattern of double beeps Low-pitched single -beep Repeat pattern of double beeps Low-pitched single beep None None Alarm message White text inside a red box Black text inside a yellow box Black text inside a cyan box White text Alarm messages are displayed in the alarm information area at the top of the screen. You can select the alarm messages to show the alarm list. The indicator appears in front of the corresponding alarm message. Alarm priority indicator Parameter value
***
**
*
None White text inside a flashing red box Black text inside a flashing yellow box Black text inside a flashing cyan box None None highest priority alarm to light the alarm lamp and issue the alarm tone. the same area, the monitor only displays the messages from the highest priority alarm. NOTE When multiple alarms of different priority levels occur simultaneously, the monitor selects the When multiple alarms of different priority levels occur simultaneously and should be displayed in When multiple alarms of the same priority levels occur simultaneously and should be displayed in the same area, all the alarm messages are displayed cyclically. Some physiological alarms, such as Asystole, are exclusive. They have identical alarm tones and alarm lights with normal high level physiological alarms, but their alarm messages are displayed exclusively. That is, when an exclusive physiological alarm and a normal high level physiological alarm are triggered simultaneously, only exclusive physiological alarm message will be displayed. 7 - 2 7.3.4 Alarm Status Symbols Apart from the alarm indicators as described in 7.3.3Alarm Indicators, the monitor uses the following symbols to indicate the alarm status:
Alarm pause:
indicates that all the alarms are paused. Alarm off:
indicates that individual measurement alarms are turned off or the system is in the alarm off status. Audio pause:
indicates that audible alarm tones are paused. Audio off:
indicates that audible alarm tones are turned off. Alarm reset:
indicates that alarms are acknowledged and the alarm system is reset. 7.4 Accessing On-screen Help for Technical Alarms (AlarmSight) In the technical alarm list, alarm messages followed by Detail include help messages or pictures to help you identify the problem. This function is called AlarmSight. To access AlarmSight, follow this procedure:
1. 2. Select an alarm displaying in the technical alarm information area to enter the Alarms dialog. From the alarm list select the desired alarm. NOTE If there are no displayed alarms, then selecting the technical alarm area will not open any dialogs. 7.5 Checking the Physiological Alarms List If the patient monitor has more than one physiological alarm, you can see the physiological alarm list by selecting the physiological alarm information area to enter the Alarms dialog. If there is only one physiological alarm, selecting the physiological alarm information area enters the Review dialog for the event created by this alarm. 7 - 3 7.6 7.6.1 Changing Alarm Settings Alarms settings can be changed by selecting Main Menu and choosing from the list in the Alarm column. Setting Parameter Alarm Properties To set parameter alarm properties, follow this procedure:
1. Access the Limits page in either of the following WAYS:
Select the Alarm Setup quick key. Select the Main Menu quick key from the Alarm column select Limits. Select a parameter tab and set alarm properties as desired. 2. You can also change the alarm properties of individual parameter from the corresponding parameter dialog. NOTE The monitor may be configured to require an password or login to change alarm settings. For more information, refer to 25.13.3Selecting Password for User Authentication. 7.6.2 Setting Alarm Tone Properties 7.6.2.1 Changing the Alarm Volume To change the alarm volume, follow this procedure:
1. 2. 3. 4. Access the Setup page in either of the following ways:
Select the Alarm Setup quick key select the Setup tab. Select the Main Menu quick key from the Alarm column select Setup. Set Alarm Volume. The alarm volume can be set from X to 10, in which X is the minimum volume allowed by your department, and 10 is the maximum volume. Select High Alarm Volume to set the volume of the high priority alarm. Select Reminder Volume to set the volume of the reminder tone. NOTE Alarm volume can only be set to 0 if the monitor is connected to a Central Monitoring System. When the alarm volume is set to 0, the alarm sound is turned off and the audio off symbol appears on the screen. 7 - 4 You cannot set the volume of high priority alarms if Alarm Volume is set to 0. You can set the Alarm Volume to 0 only when your monitor is connected to the CMS. If your monitor When your monitor is connected to the CMS and Alarm Volume is set to 0, Alarm Volume is not connected to the CMS, the lowest setting of Alarm Volume is 1. automatically changes to 2 if the CMS is disconnected. 7.6.3 Setting the Auto Limits for New Patient Switch If the Auto Limits for New Patient function is enabled, a dialog box can pop up to ask you whether to set alarm limits based on the latest parameter measurements for a newly admitted patient. To set the Auto Limits for New Patient switch, follow this procedure:
1. 2. Enter the alarm setup page in any of the following ways:
Select the Alarm Setup quick key select the Setup tab. Select the Main Menu quick key from the Alarm column select Setup. Set the Auto Limits for New Patient switch. When Auto Limits for New Patient is switched on, the confirmation dialog box pops up if all of the following requirements are met:
Within 10 minutes after the patient is admitted. Continuous measurements are stable. An NIBP measurement has been taken HR alarm switch is on. No fatal alarms are triggered. The patient is not in poor perfusion condition. Alarm limit of any parameter was not manually changed. The monitor is not in intubation mode, rescue mode, private mode, or CPB mode. NOTE The Auto Limits for New Patient function is intended for newly admitted patients only. The automatically set alarm limits take effect only after being confirmed. 7.6.4 Initiating Auto Alarm Limits The monitor provides the auto alarm limits function to automatically adjust alarm limits according to the patients vital signs. When auto limits are selected, the monitor calculates safe auto limits based on the latest measured values. To get accurate auto alarm limits, collect a set of measured vital signs as a baseline. To initiate auto alarm limits, follow this procedure:
1. 2. 3. Access the Limits page in either of the following ways:
Select the Alarm Setup quick key. Select the Main Menu quick key from the Alarm column select Limits. From the Limits page, select Auto Limits at the left bottom. Select OK from the popup dialog box. Then the monitor will automatically calculate alarm limits based on the latest measured values. Before applying these automatically created alarm limits, confirm if they are appropriate for the patient from the Limits dialog. If not, you can adjust them manually. These alarm limits will remain unchanged until you select auto limits again or adjust them manually. The monitor calculates auto limits based on the following rules:
7 - 5 Module Parameter Lower Limit ECG HR/PR
(bpm) Adult/
pediatric Neonate HR 0.8 or 40
(whichever is greater)
(HR - 30) or 90
(whichever is greater) Upper Limit Adult/
pediatric Neonate HR 1.25 or 240
(whichever is smaller)
(HR + 40) or 200
(whichever is smaller) Auto Limit Range Adult/pediatric: 35 to 240 Neonate: 55 to 225 Resp RR (rpm) RR 0.5 or 6
(whichever is greater)
(RR - 10) or 30
(whichever is greater)
(RR 1.5) or 30 (whichever is smaller)
(RR + 25) or 85 (whichever is smaller) Adult/pediatric: 6 to 55 Neonate: 10 to 90 SpO2 SpO2 (%) Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Same as the measurement range NIBP NIBP-S
(mmHg)
(SYS 0.68 +
10)
(SYS - 15) or 45 (whichever is greater)
(SYS 0.86 +
38) NIBP-D
(mmHg)
(Dia 0.68 +
6) NIBP-M
(mmHg)
(Mean 0.68
+ 8)
(Dia - 15) or 20 (whichever is greater)
(Mean - 15) or 35 (whichever is greater)
(Dia 0.86 +
32)
(Mean 0.86
+ 35)
(SYS + 15) or 105
(whichever is smaller)
(Dia + 15) or 80 (whichever is smaller)
(Mean + 15 or 95)
(whichever is smaller) Adult: 45 to 270 Pediatric: 45 to 185 Neonate: 35 to 115 Adult: 25 to 225 Pediatric: 25 to 150 Neonate: 20 to 90 Adult: 30 to 245 Pediatric: 30 to 180 Neonate: 25 to105 Temp
(xx refers to temperat ure site) IBP: ART/
Ao/UAP/
BAP/FAP/
LV/P1-P4
(Arterial pressure) Txx (C) T (C)
(Txx - 0.5)
(Txx - 0.5)
(Txx + 0.5)
(Txx + 0.5) 1 to 49 Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Same as the measurement range IBP-S
(mmHg) SYS 0.68 +
10
(SYS - 15) or 45 (whichever is greater) SYS 0.86 +
38 IBP-D
(mmHg
(Dia 0.68 +
6) IBP-M
(mmHg) Mean 0.68 +
8
(Dia 0.86 +
32) Mean 0.86 +
35
(Dia - 15) or 20 (whichever is greater)
(Mean - 15) or 35
(whichever is greater)
(SYS + 15) or 105
(whichever is smaller)
(Dia + 15) or 80 (whichever is smaller)
(Mean + 15) or 95
(whichever is smaller) Adult: 45 to 270 Pediatric: 45 to 185 Neonate: 35 to 115 Adult: 25 to 225 Pediatric: 25 to 150 Neonate: 20 to 90 Adult: 30 to 245 Pediatric: 30 to180 Neonate: 25 to 105 IBP: PA IBP: CPP IBP-S
(mmHg) IBP-D
(mmHg IBP-M
(mmHg) CPP
(mmHg) SYS 0.75 SYS 0.75 SYS 1.25 SYS 1.25 3 to 120 Dia 0.75 Dia 0.75 Dia 1.25 Dia 1.25 3 to 120 Mean 0.75 Mean 0.75 Mean 1.25 Mean 1.25 3 to 120 CPP 0.68 + 8 CPP 0.86 +
35
(CPP-15) or 35,
(whichever is greater)
(CPP+15) or 95,
(whichever is smaller) Adult: 20 to 235 Pediatric: 25 to175 Neonate: 25 to 100 7 - 6 Module Parameter Lower Limit Adult/
pediatric Neonate Upper Limit Adult/
pediatric Neonate Auto Limit Range IBP: CVP/
LAP/
RAP/
UVP/P1-
P4
(Venous pressure) CO2 AG IBP-M
(mmHg) Mean 0.75 Mean 0.75 Mean 1.25 Mean 1.25 3 to 40 EtCO2
(mmHg) 0 to 32:
remains the same 0 to 32:
remains the same 0 to 32:
remains the same 0 to 32:
remains the same Same as the measurement range 33 to 35: 29 33 to 35: 29 33 to 35: 41 33 to 35: 41 36 to 45:
(etCO2 - 6) 36 to 45:
(etCO2 - 6) 36 to 45:
(etCO2 + 6) 36 to 45:
(etCO2 + 6) 46 to 48: 39 46 to 48: 39 46 to 48: 51 46 to 48: 51 Same as the measurement range Same as the measurement range Same as the measurement range
>48: remains the same
>48: remains the same
>48: remains the same
>48: remains the same Same as the measurement range FiCO2 None None Same as the default alarm limit Same as the default alarm limit Same as the measurement range awRR
(rpm) EtCO2 FiCO2 awRR
(rpm) FiAA/EtAA FiO2/EtCO2 FiN2O/
EtN2O awRR 0.5 or 6 (whichever is greater)
(awRR - 10) or 30 (whichever is greater) awRR 1.5 or 30 (whichever is smaller)
(awRR+25) or 85 rpm
(whichever is smaller) Adult/pediatric: 6 to 55 Neonate: 10 to 90 Same as the CO2 module Same as the CO2 module awRR 0.5 or 6 (whichever is greater)
(awRR - 10) or 30 (whichever is greater) awRR 1.5 or 30 (whichever is smaller) awRR+25 or 85 (whichever is smaller) Adult/pediatric: 6 to 55 Neonate: 10 to 90 Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Adult: (TB - 1) Pediatric: N/A Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit N/A N/A N/A Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit Adult: (TB + 1) Pediatric: N/A N/A N/A Same as the default alarm limit Same as the default alarm limit Same as the default alarm limit N/A N/A N/A Same as the measurement range Same as the measurement range Same as the measurement range Same as the measurement range N/A N/A C.O. TB (C) C.I. TFC N/A N/A 7.6.5 Setting the Apnea Delay Time To set the zero respiration rate delay time, follow this procedure:
1. Access the Setup page in either of the following ways in either of the following ways:
Select the Alarm Setup quick key select the Setup tab. Select the Main Menu quick key from the Alarm column select Setup. 7 - 7 2. Select Apnea Delay to set the zero respiration rate delay time. 7.6.6 Switching on or off V-Tach Latching When V-Tach Latching Lock is switched on, you can switch on or off V-Tach Latching. To do so, follow this procedure:
1. 2. Access the Setup page in either of the following ways in either of the following ways:
Select the Alarm Setup quick key select the Setup tab. Select the Main Menu quick key from the Alarm column select Setup. Switching on or off V-Tach Latching. 7.6.7 Restoring the Default Alarm Settings To reset all alarm settings to the defaults, follow this procedure:
1. Access the Alarm page in either of the following ways:
Select the Alarm Setup quick key. Select the Main Menu quick key from the Alarm column select Limits. On the Limits page, select Defaults at the bottom. 2. 7.6.8 Setting the Length of Printed Waveforms You can define the length of printed waveforms when an alarm is triggered. To do so, follow this procedure:
1. 2. Access the Setup page in either of the following ways:
Select the Alarm Setup quick key select the Setup tab. Select the Main Menu quick key from the Alarm column select Setup. Set Printing Duration On Alarm. 7.7 7.7.1 Pausing Alarms/Pausing Alarm Tones You can either pause alarms or pause alarm tones. This depends on the pause setting. To set the pause function, refer to 25.3.3Defining the Pause Function. Pausing Alarms If the Pause function is configured to alarm pause, pressing the Alarm Pause quick key can temporarily disable alarm indicators. For the configuration of the pause function, see 25.3.3Defining the Pause Function. When alarms are paused, the following rules are followed:
No physiological alarm will be presented. For technical alarms, alarm sounds are paused, but alarm lamps and alarm messages continue to be presented. The remaining alarm pause time is displayed in the physiological alarm information area. The alarm pause symbol is displayed in the system information area. When the alarm pause time expires, the alarm paused state is automatically deactivated. You can also cancel the alarm paused state by pressing the Alarm Pause quick key again. 7.7.1.1 Prolonging the Alarm Pause Time If enabled, you can temporarily prolong the alarm pause time after the monitor enters the alarm paused state. This capability is disabled by default. To prolong the alarm pause time, follow this procedure:
1. 2. In the physiological alarm information area, select the alarm pause countdown. Select Pause 5 min, Pause 10 min, or Pause 15 min. 7 - 8 NOTE Prolonging alarm pause time does not affect the setting of alarm pause time. 7.7.1.2 Switching Off All Alarms If Pause Time is set to Permanent (see section 25.3.3.1Setting the Alarm Pause Time/Alarm Tone Pause Time), Pressing the Alarm Pause quick key permanently switches off all alarms. The alarm off state has the following features:
Physiological alarms are switched off. The alarm lamp does not flash and alarm sound is not issued. Alarm sound of technical alarms is switched off, but alarm lamp flashes and alarm messages are presented. The message Alarm Off with red background is displayed in the physiological alarm information area. The alarm off symbol is displayed in the system status information area. To exit the alarm off state, press the Alarm Pause quick key again. WARNING Pausing or switching off alarms may result in a hazard to the patient. 7.7.2 Pausing Alarm Sound If the Pause function is configured to Audio Pause, pressing the Audio Pause quick key pauses alarm tone and sets the quick key to be highlighted. For the configuration of the pause function, see section 25.3.3Defining the Pause Function. When alarm tones are paused, the following rules are followed:
The sound of all physiological alarms and technical alarms are switched off. The remaining audio pause time is displayed in the physiological alarm information area. The audio pause symbol is displayed in the system information area. When the audio pause time expires, the audio paused state is automatically deactivated. You can also cancel the audio paused state by pressing the highlighted Audio Pause quick key. 7.7.2.1 Prolonging the Alarm Tone Pause Time If enabled on the machine, you can temporarily prolong the alarm tone pause time after the monitor enters the alarm tone paused state. This capability is disable by default. To prolong the audio pause time, follow this procedure:
1. 2. In the physiological alarm information area, select the alarm pause countdown. Select the alarm tone pause time. Options may include Pause 5 min, Pause 10 min, or Pause 15 min. NOTE Prolonging alarm pause time does not affect the setting of alarm tone pause time. 7.7.2.2 Switching Off Alarm Sound If Pause Time is set to Permanent (see section 25.3.3.1Setting the Alarm Pause Time/Alarm Tone Pause Time), pressing the Audio Pause quick key permanently switches off all alarm sound. The audio off state has the following features:
Alarm sound of both physiological alarms and technical alarms is switched off. The audio off symbol is displayed in the system information area. To exit the audio off state, press the Audio Pause quick key again. WARNING Pausing or switching off alarm sound may result in a hazard to the patient. 7 - 9 7.8 Resetting Alarms Press the Alarm Reset quick key to acknowledge the ongoing alarms and reset the alarm system. When the alarm system is reset, the alarm reset symbol displays in the system status information area for alarm symbols. NOTE If a new alarm is triggered after the alarm system is reset, the alarm reset icon will disappear and the alarm light and alarm tone will be reactivated. 7.8.1 Resetting Physiological Alarms For physiological alarms, when the alarm system is reset, the following occur:
The alarm sound is silenced. A appears before the alarm message, indicating that the alarm is acknowledged. The color of the parameter numeric background corresponds with the alarm priority, but the parameter numeric does not flash. 7.8.2 Resetting Technical Alarms For technical alarms, when the alarm system is reset, the following occur:
Some technical alarms are cleared. The monitor gives no alarm indications. Some technical alarms are changed to prompt messages. For some technical alarms, the alarm is silenced and a appears before the alarm message, indicating that the alarm is acknowledged. For details about the indications of technical alarms when the alarm system is reset, see D.2Technical Alarm Messages. 7.9 Latching Alarms The latching setting for physiological alarms defines how alarm indicators behave if you do not reset the alarms. If you do not latch physiological alarms, their alarm indications disappear when the alarm condition ends. If you latch physiological alarms, all visual and audible alarm indications remains (if configured) until the alarms are reset. For latched alarms the time when the alarm is last triggered is displayed behind the alarm message. The monitor can be set to separately latch visual indications or simultaneously latch the visual and the audible indications. When visual indications are latched, visual indications, including alarm lamp, alarm message and its background remains when the alarm condition ends and the time when the alarm last triggered is displayed behind the alarm message. When audible indications are latched, the monitor continues to issues alarm sounds when the alarm condition ends. To set how you want to latch the physiological alarms, see section 25.3.4Latching Physiological Alarms. NOTE Changing alarm priority may affect the latching status of the corresponding alarm. Determine if you need to adjust the latching status for the specific alarm when you have changed its alarm priority. When the alarm system is reset, latched physiological alarms are cleared. 7 - 10 7.10 Nurse Call The monitor provides a nurse call connector to output a nurse call signal when a user-defined alarm occurs. To obtain a nurse call signal, use the nurse call cable to connect the hospital nurse call system with the monitors nurse call connector. Alarms are indicated on the nurse call device only when the following conditions are met:
The nurse call system is enabled. A user-defined alarm occurs. Alarms are not paused or reset. WARNING Do not rely exclusively on the nurse call system for alarm notification. Remember that the most reliable alarm notification combines audible and visual alarm indications with the patients clinical condition. 7.11 7.11.1 Calling for Help This monitor can be configured to call monitors in the same department, the central station, and the nurse call system so that nearby doctors and nurses can come for help. Issuing the Call Help Signal To call help, select the Call Help quick key and select OK from the popup dialog box. If OK is not selected within 5 seconds then the monitor will automatically send out the call help signal. After the call help signal is sent out, the Call Help quick key flashes in red. Select the Call Help quick key again to stop the call help signal. Monitors receiving the call help signal issue a sound and a dialog box pops up indicating which monitor is calling. Select OK to acknowledge the call and stop the sound at this monitor. NOTE The call help function works only when the monitor is connected to the network. The call help sound may disturb patients in the same department. 7.12 CPB Mode The CPB (Cardiopulmonary Bypass) mode is activated only if you set the department to OR. In the CPB mode, all the physiological alarms and technical alarms are switched off. So when performing CPB, you can put the monitor in the CPB mode to inactivate unnecessary alarms. 7.12.1 Entering the CPB Mode To enter the CPB mode, choose either of the following ways:
Select the CPB Mode quick key. Select the Main Menu quick key from the Alarm column select CPB Mode. In the CPB mode, CPB Mode is displayed in the physiological alarm area with a red background color. NOTE When the CPB mode is entered, the monitor stops all NIBP measurements. You can restart NIBP measurements after entering the CPB mode. 7 - 11 7.12.2 Exiting the CPB Mode To exit the CPB mode, choose either of the following ways:
Select the CPB Mode quick key. Select the Main Menu quick key from the Alarm column select Exit CPB Mode. 7.13 Intubation Mode Intubation mode is available for Resp, CO2, and AG monitoring. When performing intubation during general anesthesia, you can put the monitor in the intubation mode in order to inactivate unnecessary alarms. In the intubation mode, Resp, CO2 and AG related physiological alarms are switched off. 7.13.1 Entering the Intubation Mode To enter the intubation mode, choose either of the following ways:
Select the Intubation Mode quick key. From the bottom of the Resp, CO2, or AG dialog, select Intubation Mode. Select the Main Menu quick key from the Alarm column select Intubation Mode. 7.13.2 Exiting the Intubation Mode To exit the intubation mode, choose either of the following ways:
Select the Intubation Mode quick key. From the bottom of the Resp, CO2, or AG dialog, select Exit Intubation Mode. Select the Main Menu quick key from the Alarm column select Exit Intubation Mode. 7.14 Testing Alarms The monitor automatically performs a selftest at startup. Check that an alarm tone is heard, the alarm lamp illuminates, one after the other, in red, yellow, and cyan. This indicates that the visible and audible alarm indicators functions correctly. 7 - 12 8 Monitoring ECG, Arrhythmia, ST and QT 8.1 ECG Introduction The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the monitor as waveforms and numerics. ECG monitoring provides 3-, 5-, 6-, and 12-lead ECG monitoring, ST-segment analysis, arrhythmia analysis, QT/QTc measurements, and optional 12-lead resting analysis via the Glasgow algorithm. The associated monitor incorporating ST analysis has the ST label. The associated monitor incorporating 12-lead has the 12-lead label. 8.2 ECG Safety Information This equipment is not intended for direct cardiac application. Ensure that the conductive parts of ECG electrodes and associated connectors, including the neutral electrode, do not come into contact with any other conductive parts including earth. WARNING Always use defibrillation-proof ECG cables during defibrillation. Do not touch the patient, or metal devices connected to the patient, during defibrillation. To minimize the hazard of burns during high-frequency surgical procedures, ensure that the monitors cables and transducers never come into contact with the electrosurgery unit (ESU). To minimize the hazard of burns during use of high-frequency surgical unit (ESU), the ECG electrodes should not be located between the surgical site and the ESU return electrode. CAUTION Only use parts and accessories specified in this manual. Follow the instructions for use and adhere to all warnings and cautions. Periodically inspect the electrode application sites to ensure skin integrity. If the skin quality changes, replace the electrodes or change the application site. Interference from an ungrounded instrument near the patient or electrosurgery usage can induce noise and artifact into the waveforms. 8.3 ECG Display The following figures show the ECG waveform and numeric areas. The display may be configured to look slightly different.
(1) (2) (3) (4) (5) (6)
(7) 8 - 1
(1) ECG lead label of the displayed waveform
(2) ECG waveform gain
(3) ECG filter mode
(4) Notch filter status
(5) Paced status: If Paced is set to Yes, is displayed. If Paced is set to No, is displayed.
(6) HR/PR alarm message
(7) Pace pulse marker: If Paced is set to Yes, pace pulse markers | are displayed corresponding to detected pacer for each beat.
(1)
(2)
(3)
(4)
(1) Parameter label
(3) HR alarm limits
(2) HR measurement unit
(4) HR value 8.4 Preparing for ECG Monitoring 8.4.1 Preparing the Patient Skin Proper skin preparation is necessary to ensure good signal quality at the electrode sites, as the skin is a poor conductor of electricity. To properly prepare the skin, choose flat areas and then follow this procedure:
1. 2. 3. 4. Shave hair from skin at chosen electrode sites. Gently rub skin surface at sites to remove dead skin cells. Thoroughly cleanse the site with a mild soap and water solution. We do not recommend using ether or pure alcohol, because this dries the skin and increases the resistance. Dry the skin completely before applying electrodes. 8.4.2 Applying Electrodes and Connecting the Patient To connect ECG cables, follow this procedure:
1. 2. 3. 4. Check that electrode packages are intact and the electrodes are not past the expiry date. Ensure the electrode gel is moist. If you are using snap electrodes, attach the snaps to the electrodes before placing electrodes on the patient. Place the electrodes on the prepared sites. Ensure that all electrodes have good skin contact. Connect the leadwires to the patient cable if not already connected. Plug the patient cable into the ECG connector. CAUTION Never mix patient electrode types or brands. This may lead to impedance mismatches issues. NOTE When applying the electrodes, avoid bony area, obvious layers of fat, and major muscles. Muscle movement can result in electrical interference. Applying electrodes on major muscles, for example 8 - 2 on muscles of the thorax, may lead to erroneous arrhythmia alarms due to excessive muscle movement. 8.4.3 Lead Wire Color Code The following table lists the color coding of leadwires for AHA standards:
Lead Right arm Left arm Right leg (neutral) Left leg Chest 1 Chest 2 Chest 3 Chest 4 Chest 5 Chest 6 Label RA LA RL LL V1 V2 V3 V4 V5 V6 Color White Black Green Red Brown/Red Brown/Yellow Brown/Green Brown/Blue Brown/Orange Brown/Violet 8.4.4 8.4.4.1 ECG Electrode Placements In this section, electrode placement is illustrated using the AHA naming convention. 3-leadwire Electrode Placement The following is the electrode configuration when a 3-leadwire cable is used:
RA 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. 8.4.4.2 5-leadwire and 6-leadwire Electrode Placement The following is the electrode configuration for a 5-leadwires cables:
RA placement: directly below the clavicle and near the right RA shoulder. LA placement: directly below the clavicle and near the left shoulder. RL placement: on the right lower abdomen. LL placement: on the left lower abdomen. V placement: on the chest in any of the V1 to V6 positions. V RL For 6-leadwire placement, you can use the position for the 5 -
leadwire placement but with two chest leads. The two chest leads (Va and Vb) can be positioned at any two of the V1 to V6 positions. For LA LL LA LL 8 - 3 more information, see 8.4.4.3Chest Electrode Placement. The Va and Vb lead positions are configurable. For more information, see 8.5.3.3Changing Va and Vb Labels. 8.4.4.3 Chest Electrode Placement The chest electrode can be placed at the following positions:
V1 placement: on the fourth intercostal space to the right of the sternum. V2 placement: on the fourth intercostal space to the left of the sternum. V1 V3 placement: midway between the V2 and V4 electrode positions. V4 placement: on the fifth intercostal space at the left midclavicular line. V5 placement: on the left anterior axillary line, horizontal with the V4 electrode position. V6 V5 V4 V2 V3 V6 placement: on the left midaxillary line, horizontal with the V4 electrode position. V3R-V6R placement: on the right side of the chest in positions corresponding to those on the left. NOTE For the 5-leadwire and 6-leadwire placement, place the precordial electrode according to the physician's preference. 8.4.4.4 10-leadwire Electrode Placement 12-lead ECG uses 10 electrodes, which are placed on the patients four limbs and chest. The limb electrodes should be placed on the limb extremities and the chest electrodes placed according to the physicians preference. The figure at right illustrates the conventional 10-leadwire electrode placement. 8.4.4.5 Lead Placement for Surgical Patients The surgical site should be taken into consideration when placing electrodes on a surgical patient. For example, for open-chest surgery, the chest electrodes can be placed on the lateral chest or back. To reduce artifacts and interference from electrosurgical units, you can place the limb electrodes close to the shoulders and lower abdomen and the chest electrodes on the left side of the mid-chest. Do not place the electrodes on the upper arm. Otherwise, the ECG waveform will be very small. 8 - 4 To reduce the hazard of burns during use of electrosurgical units (ESU), the ECG electrodes should not be located between the surgical site and the ESU return electrode. WARNING Never entangle the ESU cable and the ECG cable together. When using ESU, never place ECG electrodes near the grounding plate of the ESU, as this can cause a When using electrosurgery units, ensure proper contact of the ESU return electrode to the patient to lot of interference on the ECG signal. avoid burns at monitor measurement sites. Also ensure that the ESU return electrode is near the operating area. 8.4.5 Choosing the ECG Lead Type To choose ECG lead type, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set Lead Set according to the lead type you are going to use. The default lead type is Auto. In this case, the monitor automatically detects the lead type. 8.4.6 Checking Paced Status It is important to correctly set the patients paced status before you start monitoring ECG. The paced symbol is displayed when Paced is set to Yes. Pace pulse markers | are displayed on each ECG waveform whenever a pacer signal is detected. If Paced is set to No or unspecified, the symbol area. will be shown in the ECG waveform To change the paced status, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Pacer tab. Set Paced to Yes or No. You can also change the patients paced status from the Patient Management dialog. For more information, see 5.2.1Entering the Patient Management Dialog. If you did not set the paced status, the monitor issues a prompt tone when pace pulse is detected. At the same flashes and the message Please check if the patient has a pacemaker? appears in time, the paced symbol the ECG waveform area. Check and set the patients paced status. WARNING For paced patients, you must set Paced to Yes. If it is incorrectly set to No, the monitor could mistake a pace pulse for a QRS complex and fail to alarm when the ECG signal is too weak. On ventricular paced patients, episodes of ventricular tachycardia may not always be detected. Do not rely entirely upon the systems automated arrhythmia detection algorithm. False low heart rate or false asystole alarms may result with certain pacemakers because of pacemaker artifacts, such as electrical overshoot of the pacemaker overlapping the true QRS complexes. Do not rely entirely on rate meter alarms when monitoring patients with pacemakers. Always keep these patients under close surveillance. The auto pacer recognition function is not applicable to pediatric patients, neonatal patients, and patients with NMT monitoring. 8 - 5 8.4.7 Enabling Pacer Rejection The pace pulse rejection function is disabled by default. To enable this function, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Pacer tab. Switch on Pacer Reject. NOTE When pace pulses are detected, the pace pulse markers | are shown on the ECG waveforms. Pacer You can switch on pacer rejection only when Paced is set to Yes. If Paced is set to no, the Pacer Reject Rejection setting has no impact on the display of pace pulse markers |. function is disabled. 8.5 Changing ECG Settings 8.5.1 Choosing an ECG Screen When monitoring ECG, several display options are available. For 3-lead ECG monitoring, only normal screen is available. For 5-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (7-lead) or Half Screen (7-lead). For 6-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (8-lead) or Half Screen (8-lead). For 12-lead ECG monitoring, besides the normal screen, you can also choose Full-screen (7-lead), Half Screen (7-lead), or 12-Lead (12-lead analysis). To choose the desired screen configuration, follow this procedure:
1. 2. Select the ECG numeric area or waveform area to enter the ECG dialog. Select Full-Screen, Half-Screen, or 12-Lead when visible. To return to the normal screen, press the highlighted button to unselect that screen. Alternately you can choose the desired screen configuration as follows:
1. 2. Select the Screen Setup quick key Choose Screen or select the Main Menu quick key from the Display column select Choose Screen. Select ECG Full-Screen, ECG Half-Screen, or ECG 12-Lead. 8.5.2 Setting ECG Alarm Properties To select the desired ECG alarm options, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Alarm tab. Select the desired alarm options. 8.5.3 Changing ECG Wave Settings 8.5.3.1 Selecting the Leads of Displayed ECG Waveforms To select the desired ECG waveforms to be displayed, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Select ECG to set the lead of each displayed ECG waveform. 8 - 6 4. If more than three ECG waveforms are to be displayed, select the More Leads tab, and then select ECG to set leads of other ECG waveforms. For optimal ECG analysis, select leads with the following characteristics:
The QRS complex should be either completely above or below the baseline and it should not be biphasic. The QRS complex should be tall and narrow. The P waves and T waves should be less than 0.2mV. CAUTION Ensure that you have selected the optimal leads with the best waveform amplitude and the highest signal-to-noise ratio. Selecting the optimal leads is important for detecting beats, classifying beats, and detecting ventricular fibrillation. 8.5.3.2 Changing ECG Waveform Size If the ECG waveform is too small or clipped, you can change its size by selecting the appropriate Gain setting. To do so, follow this procedure:
1. 2. 3. 4. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Select ECG gain to set the size of each ECG waveform. If more than three ECG waveforms are displayed, select the More Leads tab, and then select ECG Gain to change the sizes of other ECG waveforms. If you select Auto, the monitor automatically adjusts the size of the ECG waveforms for all the leads. 8.5.3.3 Changing Va and Vb Labels When monitoring ECG with 6-leadwire. You can change the labels of Va and Vb leads. To do so, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set Va and Vb according to the locations of the Va and Vb electrode sites. Default settings are Va and Vb. 8.5.3.4 Changing ECG Waveform Speed To change ECG waveform speed, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set the desired Speed. 8.5.3.5 Setting the ECG Filter To set the appropriate ECG waveform filter mode, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set Filter. Diagnostic: use when diagnostic quality ECG is required. The unfiltered ECG waveform is displayed so that changes such as R-wave notching or discrete elevation or depression of the ST segment are visible. Monitor: use under normal monitoring conditions. Surgery: use when 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 wandering or rough baseline. The surgery filter reduces 8 - 7 artifacts and interference from electrosurgical units. Under normal measurement conditions, selecting Surgery may suppress certain features or details of the QRS complexes. ST: recommended for ST monitoring. 8.5.3.6 Switching On or Off the Notch Filter The notch filter removes the line frequency interference. To switch on or off the notch filter, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Switch on or off Notch Filter. NOTE The notch filter can only be switched on or off when ECG Filter is set to Diagnostic. In other filter modes, the notch filter is always on. 8.5.4 Disabling the Smart Lead Off Function The monitor provides the smart lead off function. When the lead corresponding to the first ECG wave gets detached but another lead is available, the monitor automatically switches to the available lead to recalculate heart rate, and to analyze and detect arrhythmias. When you reconnect the detached leads, the monitor automatically switches back to the original lead. The smart lead off function is enabled by default. To disable this function, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Switch off Smart Lead. 8.5.5 Adjusting the QRS Volume To adjust the QRS volume, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set QRS Volume. When valid SpO2 measurements are available, the monitor adjusts the pitch of QRS tone based on the SpO2 value. 8.5.6 Adjusting the Minimum QRS Detection Threshold To avoid false asystole alarm due to low R wave amplitude, and to avoid tall T waves and P waves being mistaken for QRS complexes, the monitor provides a means to manually adjust the minimum QRS detection threshold. To adjust the minimum QRS detection threshold, follow this procedure:
1. 2. 3. 4. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab and set Filter to Monitor. Select the QRS Threshold tab. Select up or down arrow buttons to adjust the minimum threshold for QRS detection. Selecting Default resets the QRS threshold to the default value (0.16 mV). CAUTION The setting of the QRS detection threshold can affect the sensitivity for arrhythmia, ST, QT/QTc detection, and heart rate calculation. 8 - 8 If the QRS amplitude is low, the monitor might not be able to detect the beats and false asystole calls may occur. NOTE The minimum QRS detection threshold can only be adjusted when the ECG filter is set to Monitor. 8.6 Monitoring Arrhythmia Arrhythmia monitoring is intended for adult and pediatric patients. 8.6.1 Arrhythmia Safety Information WARNING Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmias. Always keep these patients under close surveillance. The arrhythmia analysis program is intended to detect ventricular arrhythmias and atrial fibrillation. It is not designed to detect all the atrial or supraventricular arrhythmias. It may incorrectly identify the presence or absence of an arrhythmia. Therefore, a physician must analyze the arrhythmia information with other clinical findings. Atrial fibrillation (Afib) detection function is not intended for pediatric and neonatal patients. CAUTION Since the arrhythmia detection algorithm sensitivity and specificity are less than 100%, it is possible for false arrhythmias to be detected and true arrhythmia events to not be detected. The possibility increases when the signal is noisy. The ECG size and minimum QRS detection threshold settings affect arrhythmia detection and heart rate calculation sensitivity. If QRS amplitude is low, the monitor might be unable to calculate heart rate and thus create false asystole calls. During the learning phase of the algorithm, arrhythmia detection may not be available. It is recommended to closely monitor patient condition during, and for several minutes after, the learning phase to allow the algorithm to reach optimal detection performance. 8.6.2 Arrhythmia Events This section lists all arrhythmia events and their criteria. 8.6.2.1 Lethal Arrhythmia Events Arrhythmia message Description Asystole V-Fib/V-Tach V-Tach No QRS complex detected within the set time interval in the absence of ventricular fibrillation or chaotic signal. A fibrillatory wave for 6 consecutive seconds. A dominant rhythm of adjacent PVCs and the ventricular rate is greater than the V-tach rate limit. The number of consecutive PVCs is greater than or equal to the V-Tach PVCs limit, and the ventricular rate is greater than or equal to the V-Tach rate limit. 8 - 9 8.6.2.2 Nonlethal Arrhythmia Events Arrhythmia message Description Vent Brady Extreme Tachy Extreme Brady R on T Run PVCs Couplet The number of consecutive PVCs is greater than or equal to V brady PVC limit and the ventricular rate is less than the V-Brady Rate limit. The heart rate is greater than the extreme tachycardia limit. The heart rate is less than the extreme bradycardia limit. R on T PVC is detected. More than two consecutive PVCs, but lower than the V-Brady PVCs limit, and the ventricular rate is lower than the V-Tach rate limit. A Pair of PVCs detected in between normal beats. Multiform PVC Multiform PVCs detected in Multif. PVC's Window (which is adjustable). PVC Bigeminy Trigeminy Tachy Brady One PVC detected in between normal beats. A dominant rhythm of N, V, N, V, N, V*. A dominant rhythm of N, N, V,N, N, V, N, N, V*. The heart rate is greater than the tachycardia limit. The heart rate is lower than the bradycardia limit. Pacer not Capture No QRS complex detected for 300 ms following a pace pulse (for paced patients only). Pacer not Pacing Missed Beat Nonsus V-Tach Vent Rhythm Pause Irr Rhythm No pace pulse detected for 1.75 x average R-to-R intervals following a QRS complex (for paced patients only). At least 3 consecutive Ns*, and The current RR interval is greater than 1.5 x previous RR interval, and The next RR interval is lower than 1.5 x average RR interval, and HR lower than 100 and the current RR interval is greater than 1.75 x average RR interval , or HR is greater than or equal to 100 and the current RR interval is greater than 1000 ms. The number of consecutive PVCs is lower than the V-Tach PVCs limit but greater than 2, and the ventricular rate is greater than or equal to the V-Tach Rate limit. The number of consecutive PVCs is greater than or equal to the V-Brady PVCs limit, and ventricular rate is greater than or equal to the V-Brady Rate limit but lower than V-Tach Rate limit. No QRS complex is detected within the set pause time threshold. Consistently irregular rhythm (N*, irregular RR interval change is greater than 12.5%) A-Fib (for adult only) P wave is absent and normal beat RR intervals are irregular. PVCs/min Pauses/min PVCs/min exceeds high limit. Pauses/min exceeds high limit. Irr Rhythm End Irregular rhythm no longer detected for the irregular rhythm end delay time. A-Fib End (for adult only) Atrial fibrillation no longer detected for the A-Fib end delay time.
*N: normal beat; V: ventricular beat 8.6.3 Displaying Arrhythmia Information You can display the arrhythmia information in the numeric area. To do so, follow this procedure:
1. Access Tile Layout using either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select Main Menu quick key from the Display column select Tile Layout. 8 - 10 2. Click the numeric area where you want to display the arrhythmia information, and then select ECG Arrhythmia. 8.6.4 Changing Arrhythmia Settings 8.6.4.1 Changing Arrhythmia Alarm Settings To set the arrhythmia alarm properties, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Arrhythmia tab Alarm tab. Set alarm properties as desired. NOTE You can switch off lethal arrhythmia alarms only when the monitor is set to enableLethal Arrh Alarms Off. For more information, see 25.3.9.1Setting the Lethal Arrhythmia Alarms Switch. The priority of lethal arrhythmia alarms is always high. It cannot be altered. 8.6.4.2 Changing Arrhythmia Alarm Threshold Settings You can change threshold settings for certain arrhythmia alarms. When an arrhythmia exceeds its threshold, an alarm will be triggered. To do so, follow this procedure:
1. 2. 3. 4. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Arrhythmia tab select the Threshold tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the threshold for the desired arrhythmia alarms. NOTE The asystole delay time relates to ECG relearning. When heart rate is less than 30 bpm, it is recommended to set Asystole Delay to 10 sec. 8.6.4.3 Arrhythmia Threshold Range Arrhythmia Asystole Delay Tachy (HR High) Brady (HR Low) Extreme Tachy Extreme Brady Multif PVCs Window V-Tach Rate V-Brady Rate V-Tach PVCs V-Brady PVCs PVCs/min High Pauses/min Threshold Range 3 sec to 10 sec 60 bpm to 295 bpm 16 bpm to 120 bpm 60 bpm to 300 bpm 15 bpm to 115 bpm 3 beats to 31 beats 100 bpm to 200 bpm 15 bpm to 60 bpm 3 beats to 99 beats 3 beats to 99 beats 1 to 100 1 to 15 8 - 11 Arrhythmia Pause Threshold AF/Irr Rhy End Time Threshold Range 1.5 sec, 2.0 sec, 2.5 sec, 3.0 sec 0 min, 1 min, 2 min, 3 min, 4 min, 5 min, 10 min, 15 min, 30 min 8.6.4.4 Setting Thresholds for PVC-Related Alarms PVC-related alarms are detected on the basis of the current PVC rate and the number of consecutive PVCs. To set the required thresholds for PVC-related alarms, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the Arrhythmia tab select the More Threshold tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Adjust V-Tach PVCs, V-Tach Rate, V-Brady PVCs, and V-Brady Rate as necessary to set the thresholds for the desired PVC-related alarms. The following figure illustrates the conditions under which PVC alarms will be generated if V-Tach PVCs is set to 6, V-Tach Rate is set to 130, V-Brady PVCs is set to 5, and V-Brady Rate is set to 40. If both V-Tach PVCs and V-Tach Rate are greater than or equal to the limits, a V-Tach alarm is generated. If the number of consecutive PVCs is lower than the V-Tach PVCs limit (6) but greater than 2, and PVC rate is greater or equal to the V-Tach Rate limit (130), a Nonsus V-Tach alarm is generated. If the number of consecutive PVCs is greater than or equal to the V-Brady PVCs limit (5), and PVC rate is lower than the V Brady limit (40), a Vent Brady alarm is generated. If both the V-Brady PVCs and V-Brady Rate are lower than the limits, but V-Brady PVCs is greater than 2, a Run PVCs alarm is generated. If the V-Brady PVCs and V-Brady Rate are greater than or equal to limits, but the Vent rate is is lower than V-
Tach Rate (130), a Vent Rhythm alarm is generated. 8.6.5 Intelligent Arrhythmia Alarm Normally, an arrhythmia alarm is presented when an alarm condition is detected. However, there are certain situations that can inhibit audible and visible alarm indications even though an alarm condition was detected. For more information, see 8.6.5.1Arrhythmia Alarm Chains and 8.6.5.2Arrhythmia Alarm Timeout Rules. 8 - 12 8.6.5.1 Arrhythmia Alarm Chains If multiple alarms overlap, announcing all of the detected alarm conditions would be confusing, and a more serious condition might be overlooked. So arrhythmia alarms are prioritized by alarm "chains". H i g h P r i o r i t y M e d u m i P r i o r i t y Asystole VFib/VTach VTach / Vent Brady Extreme Tachy/
Extreme Brady PVC Alarm Chain Beat Detection Alarm Chain Rate Alarm Chain AFib Alarm Chain Nonsus VTach /
Vent Rhythm Pauses/min Tachy/Brady AFib/
AFib End Run PVCs Pause HR High /
HR Low Irr. Rhythm/
Irr.Rhythm End Pacer not Capture /
Pacer not Pacing /
Missed Beats Couplet R on T Bigeminy Trigeminy PVCs/min Multiform PVC PVC 8.6.5.2 Arrhythmia Alarm Timeout Rules The following table explains how audible and visual alarms are indicated during arrhythmia alarm timeout. Previous alarm Current alarm Alarm indication Alarm in high priority chain Alarm in high priority chain Alarm light and alarm tone Alarm in medium priority chain During timeout period, alarm light and alarm tone are disabled. When the timeout period is reached, alarm light and alarm tone are reactivated. Alarm in medium priority chain Alarm in high priority chain Alarm light and alarm tone Alarm in the same medium priority chain, but with higher priority Alarm light and alarm tone The same alarm reoccurs Alarm in the same medium priority chain, but with lower priority During timeout period, alarm light and alarm tone are disabled. When the timeout period is reached, alarm light and alarm tone are reactivated. During timeout period, alarm light and alarm tone are disabled. When the timeout period is reached, alarm light and alarm tone are reactivated. Alarm in other medium priority chain Alarm light and alarm tone 8 - 13 8.6.5.3 Arrhythmia Alarm Refractory Period For the following eight alarms in medium priority chain, there is a 30-second refractory period. That is to say, if the same alarm is not presented within 30 seconds after the previous alarm disappears. Couplet R on T PVCs/min High Multiform PVCs PVC Missed Beat Pacer not Capture Pacer not Pacing 8.7 ST Segment Monitoring ST segment analysis is intended for adult, pediatric and neonatal patients.To use this feature, the MPM must be labeled to support ST analysis, see 8.1ECG Introduction. 8.7.1 ST Safety Information WARNING ST segment deviation values may be affected by such factors as certain drugs or metabolic and conduction disturbances. ST deviation is often calculated at a fixed offset from the J point. Changes in heart rate may affect ST. The significance of ST segment changes needs to be determined by a physician. This monitor provides information regarding changes in ST deviation levels. The clinical significance of the ST level change information should be determined by a physician. 8.7.2 Enabling ST Monitoring The ST monitoring function is disabled by default. Before you start ST monitoring, enable the ST function. To do so, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab select the Setup tab. Switch on ST Analysis. Reliable ST monitoring cannot be ensured under the following situations:
You are unable to get a lead that is not noisy. Arrhythmias, such as atrial fibrillation or atrial flutter, which may cause an irregular baseline. The patient is continuously ventricularly paced. The patient has left bundle branch block. In these cases, you may consider switching off ST monitoring. 8.7.3 Displaying ST Deviation Numerics To display ST numerics, follow this procedure:
1. 2. Access Tile Layout by either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select Main Menu quick key from the Display column select Tile Layout. Click the numeric area where you want to display the ST numerics, and then select ECG ST. 8 - 14 The ST parameter display area is configured differently according to the ECG cable used:
When you are using the 3-lead ECG leadwires, a separate ST numeric area does not appear on the display. The ST deviation value displays in the ECG numeric area. When you are using the 5-lead ECG leadwires, the ST numeric area displays 7 ST deviation values: ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V. When you are using the 6-lead ECG leadwires, the ST numeric area displays 8 ST deviation values: ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-Va, ST-Vb. When you are using the 12-lead ECG leadwires, the ST numeric area displays12 ST deviation values: ST-I, ST-
II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V1, ST-V2, ST-V3, ST-V4, ST-V5, ST-V6. This example shows the ST numeric area when 5-lead ECG cable is used. The monitor screen may look slightly different:
(4) (5)
(1)
(2)
(3)
(1) Parameter label
(3) ST alarm off symbol
(2) ST measurement unit
(4) Lead labels
(5) ST numerics: a positive value indicates ST segment elevation, and a negative value indicates ST segment depression. 8.7.4 Displaying ST Segments in the Waveform Area You can display ST segments in the waveform area. To do so, follow this procedure:
1. 2. Access Tile Layout by either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select Main Menu quick key from the Display column select Tile Layout. Select the waveform area where you want to display the ST segments, and then select ST ECG ST Segment. ST segment shows a QRS complex segment for each measured ST lead. The current ST segment is drawn in the same color as the ECG wave, usually green, superimposed over the stored reference segment, drawn in a different color. The information is updated once every ten seconds.
(1) (2)
(3)
(4) (5) 8 - 15
(1) ST lead
(2) Current ST deviation value
(3) Baseline ST deviation value
(4) 1 mV scale
(5) Current ST segment (green) and baseline ST segment (white) 8.7.5 Entering the ST View In ST View mode a complete QRS segment for each ST lead is displayed. The color of the current ST segments and ST deviation values is consistent with the color of the ECG waveforms, normally green. The color of the baseline ST segments and ST deviation values is white. To enter the ST View, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab. From the bottom of the dialog, select ST View. 8.7.6 Saving the Current ST Deviation and Segment as Baseline ST deviation is typically monitored as a relative change from a baseline value. Set an ST baseline when ST deviation values become stable. If you did not set the ST baseline, the monitor automatically saves the baseline when valid ST deviation values appear for 5 minutes. To set the ST baseline, follow this procedure:
1. 2. From the ST View, select Set Baseline. From the pop-up dialog box, select OK to set the current ST segments and values as the baseline. From the ST View, you can also perform the following operations:
Display or hide ST baseline by selecting Display Baseline or Hide Baseline. Display or hide the position of ISO point, J point and ST point by selecting Display Marker or Hide Marker. CAUTION Updating ST baseline affects ST alarms. 8.7.7 Entering the ST Graphic To display ST Graphic, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab. Select ST Graphic. The following figure shows the ST Graphic when ST Alarm Mode is set to Absolute. The height of the bar indicates the ST deviation value of corresponding ST lead. The color of the bar indicates ST alarm status: green indicates that corresponding ST deviation value is within alarm limits; cyan, yellow and red indicate that the ST deviation value exceeds the alarm limits. The color matches ST alarm priority. 8 - 16 The following figure shows the ST Graphic when ST Alarm Mode is set to Relative. The height of grey bar indicates the baseline ST deviation value and the green bar (cyan, yellow or red if an alarm occurs) indicates relative ST from that baseline. 8.7.8 Changing ST Settings 8.7.8.1 Setting ST Alarm Properties To set ST alarm properties, follow this procedure:
1. 2. 3. 4. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab Alarm tab. Set ST Alarm Mode to Absolute or Relative. Absolute: you can separately set the alarm properties for each ST alarm for each lead. Relative: you can set the alarm properties for ST Single and ST Dual alarms. Set ST alarm properties. 8.7.8.2 Changing Leads for ST Display The monitor automatically selects the three most deviated leads for ST display. You can also manually select the leads. To do so, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab select the Setup tab. Set ST Segment. You can select up to 3 leads. 8 - 17 8.7.8.3 Showing ISO Point, J Point, and ST Point Markers In the waveform area, the ISO point, J point, and ST point marker do not display on the ST segments by default. To display these markers, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab select the Setup tab. Switch on Show Markers. 8.7.9 Adjusting ST Measurement Points 8.7.9.1 About ST Point, ISO Point, and J Point The ST deviation value for each beat is the potential difference between the isoelectric (ISO) point and the ST point. The ISO point provides the baseline. The ST point is located between the J point and the start of the T-
wave. The J point is the end of the QRS complex. As the ST point is at a fixed distance away from the J point (40, 60, 80 etc msec), manually adjusting the J point helps you correctly position the ST point. R
(1) P Q
(2)
(3) T
(4) S
(1) ISO point
(2) J point
(3) ST point
(4) ST deviation 8.7.9.2 Setting ST Point, ISO Point, and J Point CAUTION If Auto Adjust is Off, or if the patient's heart rate or ECG morphology changes significantly, the ISO and ST points need to be occasionally adjusted because this may affect the QT interval and thus the location of the ST point. False ST segment depression or elevation may occur if the isoelectric point or the ST point is incorrectly set. Always ensure that the locations of ST points are appropriate for the patient. To set the ST point, ISO point, and J point, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the ST tab select the Adjust tab. Set ST Point. The setting for Auto Adjust defines the method of adjusting the ISO and J point locations. Auto Adjust is enabled by default. In this case, the locations of the ISO point and J point are automatically determined by the algorithm. When Auto Adjust is disabled, you need to manually adjust the position of the ISO point and J point using the arrows at the right sides of ISO and J. The ISO point (isoelectric) location shown is relative to the R-wave peak. Position the ISO point in the middle of the flattest part of the waveform (between the P and Q waves). The J point location is indicated relative to the R-wave peak. Position the J point at the end of the QRS complex and the beginning of the ST segment. 8 - 18 The ST point is positioned a fixed distance from the J point. Position the ST point relative to the J point at J+60/80ms, J+40ms, J+60ms or J+80ms. When J+60/80ms is selected, the ST point will be positioned 80 ms (heart rate 120 bpm or less) or 60 ms (heart rate more than 120 bpm) from the J point. 8.8 QT/QTc Interval Monitoring The QT interval is the time between the beginning of the Q-wave and the end of the T-wave. It represents the total duration of the depolarization (QRS duration) and repolarization (ST-T) phases of the ventricles. QT interval monitoring can assist in the detection of long QT syndrome. The QT interval has an inverse relationship to heart rate. Faster heart rates shorten QT interval and slower heart rates prolong QT interval. Therefore, several formulas are commonly used to correct the QT interval for heart rate. The heart rate corrected QT interval is abbreviated as QTc. QT/QTc interval monitoring is intended for adult, pediatric, and neonatal patients. 8.8.1 QT/QTc Monitoring Limitations Some conditions may make it difficult to achieve reliable QT/QTc monitoring, for example:
R-wave amplitudes are too low The presence of frequent ventricular ectopic beats RR intervals are unstable P-waves tending to encroach on the end of the previous T-wave at high heart rates The T-wave is very flat or T-wave are not well defined The end of the T-wave is difficult to delineate because of the presence of U-waves QTc measurements are not stable In the presence of noise, asystole, ventricular fibrillation, atrial fibrillation, or ECG lead off For reliable QT/QTc monitoring, choose lead with 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 ventricular 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 measurements when the heart rate is changing. 8.8.2 Enabling QT/QTc Monitoring The QT monitoring function is disabled by default. Before you start QT monitoring, enable the QT function. To do so, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the QT tab select the Setup tab. Switch on QT Analysis. 8.8.3 Displaying QT Numerics and Segments To display QT numerics and Segments, follow this procedure:
1. 2. Access Tile Layout by either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select Main Menu quick key from the Display column select Tile Layout. Click the parameter numeric area where you want to display the QT numerics, and then select ECG QT/
QTc. 8 - 19 NOTE QTc values are calculated based on the QT-HR, not the ECG HR. To view the QT-HR, open the QT View. For more information, see 8.8.4Entering the QT View. The following picture shows the QT numeric area. The monitor screen may look slightly different:
(3)
(2)
(1)
(4)
(5)
(6)
(1) QTc alarm limit (if QTc alarm is off, the alarm off symbol is displayed)
(2) Parameter label
(3) QTc value
(4) QTc value (the difference between the current and baseline QTc values)
(5) QT value 8.8.4 Entering the QT View QT View shows the current and baseline QT parameter values and waveforms. To enter QT View, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the QT tab. Select QT View. The following picture shows a typical QT view. The current waveform is shown in the upper half in green. The baseline waveform is shown below in white. The waveform of selected lead is highlighted, while the waveforms of other leads are in light green or light gray. The start of the QRS complex and the end of the T wave are marked with a vertical line. In some conditions, no QT measurement can be made. Then the cause of failed QT measurement is shown at the bottom of the QT numerics area and the message Cannot Analyze QT is shown in the technical alarm area. Select the left or right arrow to switch leads, and the corresponding waveform will be highlighted. 8 - 20 8.8.5 Saving the Current QTc as Baseline In order to quantify changes in the QTc value, you can set a QTc baseline. If no baseline has been set for this patient within the first five minutes after getting valid QT values, the monitor will automatically set a baseline. To set the current values as baseline, follow this procedure:
1. 2. From the QT View, select Set Baseline. From the pop-up dialog box, select OK. This baseline will then be used to calculate QTc. If you set a new baseline the previous baseline is discarded. From the QT View, you can also perform the following operations:
Select the left or right arrow to select a lead label to highlight corresponding waveform. Select Display Baseline or Hide Baseline to display or hide the baseline waveform. CAUTION Updating QTc baseline affects the QTc value and alarm. 8.8.6 Changing QT Settings 8.8.6.1 Setting QT Alarm Properties To set QT alarm properties, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the QT tab select the Alarm tab. Set QTc and QTc alarm properties. 8.8.6.2 Selecting Leads for QT Calculation You can select one lead or all leads for QT calculation. To do so, follow this procedure:
1. 2. 3. Select the ECG numeric area or waveform area to enter the ECG dialog. Select the QT tab select the Setup tab. Set QT Leads. All is selected by default. This means all leads are used for QT calculation. 8.9 ECG Relearning Changes in ECG beat morphology could result in incorrect arrhythmia alarms and/or inaccurate heart rate. ECG relearning allows the monitor to learn the new dominant beat morphology and thus reduce false arrhythmia alarms and inaccurate HR values. Once learning is complete, the dominant QRS complex is stored as a reference template. The reference template is used as the normal morphology of that patient and it is compared with incoming beats to identify possible arrhythmias. 8.9.1 Auto ECG Relearning Auto arrhythmia relearning happens in the following situation:
The ECG lead type or lead label is changed. ECG leads are off and are not reconnected within 60 seconds. The patients paced status is changed. 8 - 21 8.9.2 Initiating an ECG Relearning Manually If you suspect that false arrhythmia alarms are presented, you may need to manually initiate an ECG relearn. To do so, follow this procedure:
1. 2. Select the ECG numeric area or waveform area to enter the ECG dialog. Select Relearn. CAUTION Initiate ECG relearning only during periods of predominantly normal rhythm and when the ECG signal is relatively noise-free. If ECG learning takes place during arrhythmias, the ectopic beats may be incorrectly learned as normal QRS complexes. This may result in missed detection of subsequent arrhythmia events. 8.10 Defibrillation Synchronization Pulse Output The 12-lead MPM module provides an analog out connector to output synchronization pulses for defibrillators. If a defibrillator is connected, it receives a synchronization pulse (100 ms, +5 V) through the analog out connector each time an R-wave is detected. The 3/5/6 lead MPM module does not offer this output. WARNING According to IEC 60601-2-4: 2010, 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 (sync pulse) on the monitor is delayed by maximum of 30 ms. the biomedical engineer should verify that the ECG/
Defibrillator combination does not exceed recommended maximum delay of 60 ms. Before defibrillation, ensure that both defibrillator and monitor have passed the system test and can be safely used together. 8.11 ECG Troubleshooting This section lists some of the problems that might be encountered during ECG monitoring. If you encounter problems when using the monitor or accessories, check the table below before requesting for services. If the problem persists after you have taken corrective actions, contact the service personnel. NOTE For the physiological and technical alarm messages, see DAlarm Messages. Problem Noisy ECG traces Corrective Actions 1. Check that the electrodes are not detached or dry. Replace with fresh and moist electrodes if necessary. 2. Check that leadwires are not defective. Replace leadwires if necessary. 3. Check that the patient cable or leadwires are not routed too close to other electrical devices. Move the patient cable or leadwires away from electrical devices and their cables if necessary. Excessive electrosurgical Interference Use ESU-proof ECG cables. For more information, see 29.1ECG Accessories. Muscle Noise Inadequate skin preparation, tremors, tense subject, and/or poor electrode placement. 1. Perform skin preparation again and re-place the electrodes. For more information, see 8.4.1Preparing the Patient Skin and 8.4.2Applying Electrodes and Connecting the Patient. 2. Apply fresh, moist electrodes. Avoid muscular areas. 8 - 22 Problem Intermittent Signal Excessive alarms: heart rate, lead fault Low Amplitude ECG Signal No ECG Waveform Corrective Actions 1. Check that cables are properly connected. 2. Check that electrodes are not detached or dry. Perform skin preparation again as described in 8.4.1Preparing the Patient Skin and apply fresh and moist electrodes. 3. Check that the patient cable or leadwires are not damaged. Change them if necessary. 1. Check that electrodes are not dry. Perform skin preparation again and re-place the electrodes. For more information, see 8.4.1Preparing the Patient Skin and 8.4.2Applying Electrodes and Connecting the Patient. 2. Check for excessive patient movement or muscle tremor. Reposition the electrodes. Replace with fresh and moist electrodes if necessary. 1. Check that the ECG gain is not set too low. Adjust the gain as required. For more information, see 8.5.3.2Changing ECG Waveform Size. 2. Perform skin preparation again and re-place the electrodes. For more information, see 8.4.1Preparing the Patient Skin and 8.4.2Applying Electrodes and Connecting the Patient. 3. Check electrode application sites. Avoid bone or muscular area. 4. Check that electrodes are not dry or used for a prolonged time. Replace with fresh and moist electrodes if necessary. 1. Check that the ECG gain is not set too low. Adjust the gain as required. For more information, see 8.5.3Changing ECG Wave Settings. 2. Check that the leadwires and patient cables are properly connected. 3. Change cable and lead wires if necessary. 4. Check that the patient cable or leadwires are not damaged. Change them if necessary. Base Line Wander 1. Check for excessive patient movement or muscle tremor. Secure leadwires and cable. 2. Check that electrodes are not detached or dry and replace with fresh and moist electrodes if necessary. For more information, see 8.4.1Preparing the Patient Skin and 8.4.2Applying Electrodes and Connecting the Patient. 3. Check for ECG filter setting. Set ECG Filter mode to Monitor to reduce baseline wander on the display. 8 - 23 9 Resting 12-Lead ECG Analysis 9.1 9.2 9.3 9.4 Resting 12-Lead ECG Analysis Introduction The monitor can be configured with the Glasgow 12-lead resting ECG analysis algorithm.The monitor incorporating the Glasgow algorithm is labelled with the logo of Glasgow as shown in 8.1ECG Introduction. The Glasgow algorithm is intended for adult, pediatric, and neonatal patients. Entering the 12-Lead Screen To enter the 12-Lead screen, follow this procedure:
1. 2. Select the ECG numeric area or waveform area to enter the ECG dialog. From the bottom of the ECG dialog, select 12-Lead. You can also enter the 12-Lead screen by following this procedure:
Select the Screen Setup quick key select the Choose Screen tab select ECG 12-Lead. Select Main Menu quick key from the Display column select Choose Screen select ECG 12-Lead. NOTE The ECG 12-Lead screen is available only when the Glasgow algorithm is configured (associated module has the Glasgow label) and Lead Set is set to Auto or 12-Lead. Initiating Resting 12-Lead ECG Analysis Before initiating 12-lead ECG analysis, check that all electrodes are correctly connected to the lead wires and the ECG trunk cable is properly connected. Check that patient information is correct. Keep the patient still. To initiate 12-Lead ECG analysis, select Analyze from the bottom left of the 12-Lead screen. Changing 12-Lead ECG Analysis Settings On the ECG 12-Lead screen, you can set the high frequency filter, baseline drift removal (BDR) filter, and the waveform layout. 9.4.1 Setting the High Frequency Filter The high frequency filter attenuates muscle artifact by restricting the included frequencies. The setting of the high frequency filter is 35 Hz by default. To change the setting, follow this procedure:
1. 2. 3. On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set High-Freq Cut-off. The high frequency filter is a low-pass filter. That is to say, signal frequencies higher than the set frequency are filtered out. For example, if you set High-freq Cutoff to 35 Hz, then signal below 35 Hz is kept in the signal and signal exceeding 35 Hz is attenuated. 9 - 1 9.4.2 Setting the Baseline Drift Removal Filter The baseline drift removal (BDR) filter suppresses most baseline drift interference and also is able to preserve the fidelity of the ST-segment level. BDR is switched on by default. To set the BDR, follow this procedure:
1. 2. 3. On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Switch on or off Baseline Drift Removal as desired. If BDR is switched off, the 0.05 Hz high pass filter is used. NOTE BDR introduces around 1-second delay. Using BDR is recommended except when the delay is unacceptable. 9.4.3 Setting the 12-Lead Waveform Layout To set the 12-lead waveform layout, follow this procedure:
1. 2. 3. On the ECG 12-Lead screen, select the ECG numeric area or waveform area to enter the ECG dialog. Select the Setup tab. Set Waveform Layout. Standard: the waveform sequence is I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6. Cabrera: the waveform sequence is aVL, I, -aVR, II, aVF, III, V1, V2, V3, V4, V5, V6. For the Glasgow algorithm, the sequence of the chest leads depends on the setting of V3 placement. If V3 placement is set to V4R, the sequence of chest leads is V4R, V1, V2, V4, V5, V6. 9.4.4 Editing Patient Information Some patient information may directly affect ECG analysis. Complete and correct patient information is helpful for accurate diagnosis and treatment of the patient. Enter patient information before starting a resting ECG analysis. To enter patient information, follow this procedure:
1. 2. On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog. On the Patient Demographics page, input or edit patient information. Saving information will also save the information as though it was entered in the Patient Management dialog. NOTE Changes are not saved until you press Save. So changing to another tab without saving and then Check that patient information is correct before starting a resting 12-lead analysis. Using pediatric lead placement V4R, V1, V2, V4 - V6 is recommended if the patient is under 16 years pressing the exit button X will lose any changes. of age. Please record V4R using the V3 electrode. Also set V3 Electrode to V4R. This is a normal practice for a patient of this age. 9.4.5 Setting Tachycardia and Bradycardia Thresholds To set tachycardia and bradycardia thresholds, follow this procedure:
On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog. Select the Setup tab. Set Tachy and Brady. 1. 2. 3. 9 - 2 NOTE The tachycardia threshold only applies to patients whose age exceeds 180 days. The bradycardia threshold only applies to patients whose age exceeds 2191 days (6 years). 9.4.6 Setting the 12-Lead Interpretation Report To set the 12-lead interpretation report, follow this procedure:
1. 2. 3. On the ECG 12-Lead screen, select Setup to enter the 12-Lead Setup dialog. Select the Report tab. Set the format and items included in the 12-lead interpretation report. 9.5 9.6 9.7 Saving the 12-Lead Interpretation Report At the completion of 12-lead ECG interpretation, select Save to save the report. You can review the saved 12-
lead interpretation reports. For more information, see 18.2.1112-Lead ECG Review Page. Printing the 12-Lead Interpretation Report At the completion of 12-lead ECG interpretation, select Print or Record to output the report via printer or recorder. Exiting the ECG 12-Lead Screen To exit the ECG 12-Lead screen, select Exit on the ECG 12-Lead screen. 9 - 3 10 Monitoring Impedance Respiration (Resp) 10.1 Resp Introduction Impedance respiration is measured across the thorax. When the patient is breathing or ventilated, the volume of air changes in the lungs, resulting in impedance changes between the electrodes. Impedance respiration rate
(RR) is calculated from the signal representing these impedance changes, and a respiration waveform is displayed on the patient monitor screen. Impedance respiration monitoring is intended for adult, pediatric and neonatal patients. Respiration may also be measured using a CO2 module or anesthetic gas (AG) module. Refer to 10Monitoring Impedance Respiration (Resp) and 17Monitoring Anesthetic Gas (AG) for respiration information specific to those modules. 10.2 Impedance Resp Safety Information WARNING When monitoring the patients impedance respiration, do not use ESU-proof ECG cables. The monitor cannot measure impedance respiration with ESU-proof ECG cables. 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 zero respiration rate. 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 case of zero respiration rate. The respiration measurement does not recognize the cause of zero respiration rates. It only indicates an alarm if a pre-adjusted time has elapsed without a breath being detected since the last detected breath. Therefore, it cannot be used for diagnostic purpose. If operating under conditions according to the EMC Standard IEC 60601-1-2 (Radiated Immunity 3V/
m), field strengths above 3V/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 impedance respiration measurement unit. The current used to measure impedance respiration may cause rate changes in Minute Ventilation Rate Responsive Pacemakers. If you suspect the patient monitor is affecting the pacemaker rate then replace the ECG cable with an ECG cable that contains ESU filters. CAUTION Only use parts and accessories specified in this manual. Impedance respiration monitoring is not for use on patients while they are active, as this can cause false alarms. 10.3 Resp Display
(1)
(2)
(3)
(4)
(5) 10 - 1
(1) Resp waveform gain
(2) Resp lead label
(3) Alarm limits
(4) Respiration rate (RR)
(5) RR source NOTE If ESU-proof ECG cables are used, the Resp waveform area will display the message Check Leads. Replace the ECG cable if necessary. 10.4 Preparing for Impedance Resp Monitoring 10.4.1 Preparing the Patient Follow this procedure to prepare the patient:
1. 2. 3. 4. Shave hair from skin at chosen sites. Gently rub skin surface at sites to remove dead skin cells. Thoroughly cleanse the site with a mild soap and water solution. Dry the skin completely before applying the electrodes. CAUTION Proper skin preparation is necessary for good signal quality at the electrode site, as the skin is a poor conductor of electricity. 10.4.2 Placing the Electrodes Impedance respiration is acquired using standard ECG electrodes and cables. Either lead I (RA-LA) or lead II (RA-
LL) can be used. For more information, see 8.4.4ECG Electrode Placements
.
(1)
(2)
(1) Lead I
(2) Lead II 10 - 2 CAUTION Correct electrode placement can help to reduce interference from cardiac related impedance changes: avoid including the liver area and the ventricles of the heart between the respiratory electrodes. This is particularly important for neonates. Some patients with restricted movements 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 waveform. Some patients (especially neonates) expand their chests laterally, causing a negative intrathoracic pressure. In these cases, it is better to place the two respiration electrodes in the right midaxillary and the left lateral chest areas at the patients maximum point of the breathing movement to optimize the impedance respiration waveform. To optimize the impedance respiration waveform, place the RA and LA electrodes horizontally when monitoring respiration with ECG Lead I; place the RA and LL electrodes diagonally when monitoring respiration with ECG Lead II. Periodically inspect electrode application sites to ensure skin integrity. If the skin quality changes, replace the electrodes or change the application site. NOTE Store the electrodes at room temperature. Open the electrode package immediately prior to use. Check that the electrode packages are intact and that the electrodes are not past the expiration date. Ensure the electrode gel is moist. 10.5 Changing Resp Settings 10.5.1 Setting the Resp Alarm Properties To set the Resp alarm properties, follow this procedure:
1. 2. 3. 4. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentica-
tion. Set alarm properties as desired. 10.5.2 Setting the RR Source To set RR source, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Setup tab. Choose RR Source from the dropdown list. When you select Auto, the monitor automatically selects the RR source following order of priority: first CO2, and then ECG. When the manually selected RR source is not available, the monitor automatically switches the RR Source to Auto. 10.5.3 Choosing the Respiration Lead To set the respiration lead, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Setup tab. Set Resp Lead. If you cannot get an acceptable impedance Resp waveform or you suspect the veracity of the Resp value after choosing the Resp lead, you may need to adjust the electrode placement. 10 - 3 10.5.4 Setting the Resp Waveform Size To set the Resp waveform size, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Setup tab. Set Gain. 10.5.5 Setting the Resp Waveform Speed To set the Resp waveform speed, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Setup tab. Set Speed. 10.5.6 Setting the Auto Detection Switch To set the auto detection switch, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Setup tab. Switch on or off Auto Threshold Detection. If Auto Threshold Detection is switched on, the monitor automatically adjusts the Resp waveform detection level, or threshold. If Auto Threshold Detection is switched off, you have to manually adjust the Resp waveform threshold. For more information, see 10.5.7Adjusting the Resp Waveform Detection Threshold. In the auto threshold detection mode, if you are monitoring Resp and the ECG parameter is switched off, the monitor cannot compare the heart rate and Resp rates to detect cardiovascular artifact. The respiration detection level is automatically set higher to prevent the detection of cardiovascular artifact as respiration. In the manual detection mode (where auto threshold detection is off), cardiovascular artifact can, in certain situations, trigger the respiration rate counter. This may lead to a false indication of a high respiration or an undetected zero respiration rate condition. If you suspect that cardiovascular artifact is being registered as respiratory activity, raise the detection level above the zone of cardiovascular artifact. If the Resp wave is so small that raising the detection level is not possible, you may need to optimize the electrode placement. 10.5.7 Adjusting the Resp Waveform Detection Threshold Use the manual detection mode (where auto threshold detection is off) in the following situations:
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. To set the Resp waveform threshold to the desired level, follow this procedure:
1. 2. 3. Select the Resp numeric area or waveform area to enter the Resp dialog. Select the Threshold tab. Select the up and down arrows below Upper Line and Lower Line to define the Resp waveform threshold. 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. 10 - 4 11 Monitoring Pulse Oxygen Saturation (SpO2) 11.1 SpO2 Introduction Pulse Oxygen Saturation (SpO2) monitoring is a non-invasive technique used to measure the amount of oxygenated hemoglobin and pulse rate by measuring the absorption of selected wavelengths of light. The light generated in the emitter side of the probe is partly absorbed when it passes through the monitored tissue. The amount of transmitted light is detected in the detector side of the probe. When the pulsative part of the light signal is examined, the amount of light absorbed by the hemoglobin is measured and the pulse oxygen saturation can be calculated. This device is calibrated to display functional oxygen saturation. SpO2 monitoring is intended for adult, pediatric and neonatal patients. The monitor can be configured with Masimo or Nellcor SpO2 module:
Masimo SpO2: the connector is purple with a logo of Masimo SET. Nellcor SpO2: the connector is grey with a logo of Nellcor. Mindray SpO2: the connector is blue without any logo. NOTE The SpO2 extension cable used must be compatible with the SpO2 sensor connectors used. For example, only connect the Masimo SpO2 extension cable can be connected to the Masimo SpO2 sensor connectors. A functional tester or SpO2 simulator can be used to determine the pulse rate accuracy. A functional tester or SpO2 simulator cannot be used to assess the SpO2 accuracy. 11.2 SpO2 Safety Information WARNING When a trend toward patient deoxygenation is indicated, analyze the blood samples with a Do not use SpO2 sensors during magnetic resonance imaging (MRI). Induced current could laboratory co-oximeter to completely understand the patients condition. potentially causes burns. The sensor may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements. Prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns. Inspect the sensor site every two hours and move the sensor if the skin quality changes. Change the application site every four hours. For neonates, or patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently. If the sensor is too tight because the application site is too large or becomes too large due to edema, excessive pressure for prolonged periods may result in venous congestion distal from the application site, leading to interstitial edema and tissue ischemia. When patients are undergoing photodynamic therapy they may be sensitive to light sources. Pulse oximetry may be used only under careful clinical supervision for short time periods to minimize interference with photodynamic therapy. Setting alarm limits to extreme values may cause the alarm system to become ineffective. For example, 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 off the alarm. SpO2 is empirically calibrated in healthy adult volunteers with normal levels of carboxyhemoglobin
(COHb) and methemoglobin (MetHb). 11 - 1 CAUTION Change the application site or replace the sensor and/or patient cable when a persistent SpO2 Low Signal Quality message is displayed on the equipment. These messages may indicate that patient monitoring time is exhausted on the patient cable or sensor. Replace the cable or sensor when a SpO2 Sensor Off, SpO2 No Sensor, or SpO2 Low Signal Quality message is consistently displayed while monitoring consecutive patients after completing troubleshooting steps listed in this manual. Variation in measurements may be profound and may be affected by sampling technique as well as the patient's physiological conditions. Any results exhibiting inconsistency with the patients clinical status should be repeated and/or supplemented with additional test data. Blood samples should be analyzed by laboratory instruments prior to clinical decision making to completely understand the patients condition. Use only SpO2 sensors specified in this manual. Follow the SpO2 sensors instructions for use and adhere to all warnings and cautions. NOTE Additional information specific to the Masimo sensors compatible with the equipment, including information about parameter/measurement performance during motion and low perfusion, may be found in the sensor's directions for use (DFU). Masimo cables and sensors are provided with X-Cal technology to minimize the risk of inaccurate readings and unanticipated loss of patient monitoring. Refer to the Cable or Sensor DFU for the specified duration of the patient monitoring time. 11.3 SpO2 Measurement Limitations The following factors may influence the accuracy of SpO2 measurement:
Patient physiological characteristics:
Cardiac arrest Hypotension Darkly pigmented skin Shock Severe vasoconstriction Hypothermia Severe anemia Ventricular septal defects (VSDs) Venous pulsations Poor perfusion Dysfunctional hemoglobin, such as carboxyhemoglobin (COHb) and methemoglobin (MetHb) Elevated levels of bilirubin Vasospastic disease, such as Raynauds, and peripheral vascular disease Hemoglobinopathies and synthesis disorders such as thalassemias, Hb s, Hb c, sickle cell, etc. Hypocapnic or hypercapnic conditions Birthmark(s), tattoos, skin discolorations, moisture on skin, deformed or abnormal fingers. etc. Interfering substances:
Intravascular dyes (such as indocyanine green, methylene blue, indigo carmine, etc.) Dyes in the measure site, such as nail polish Environmental conditions:
Excessive ambient light Electrosurgery equipment 11 - 2 Defibrillation (may cause inaccurate reading for a short amount of time) Excessive patient/sensor motion Electromagnetic field Arterial catheters and intra-aortic balloon Others Inappropriate positioning of the SpO2 sensor, or use of incorrect SpO2 sensor Cuff or arterial blood pressure measurement device on the same limb as the SpO2 sensor 11.4 SpO2 Display
(5)
(4)
(1) (2) (3)
(1)
(2)
(3)
(4)
(5) Pleth waveform (Pleth/Plethb): visual indication of patients pulse. The waveform is not normalized. Oxygen saturation of arterial blood (SpO2): percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin. Perfusion indicator: the pulsatile portion of the measured signal caused by arterial pulsation. Pulse rate (derived from the pleth wave): detected pulsations per minute. Perfusion index (PI): gives the numerical value for the pulsatile portion of the measured signal caused by arterial pulsation. PI is an indicator of the pulsatile strength. You can also use it to assess the SpO2 signal strength. Above 1 is optimal. Between 0.3 and 1 is acceptable. Below 0.3 indicates low perfusion. Set Sensitivity to Maximum first. Reposition the SpO2 sensor or find a better site. If low perfusion persists, choose another method to measure oxygen saturation if possible. NOTE PI is displayed for Masimo SpO2 and Mindray SpO2 modules. 11.5 Preparing for SpO2 Monitoring To prepare to monitor SpO2, follow this procedure:
1. 2. 3. 4. 5. Select an appropriate sensor according to the module type, patient category and weight. Clean the contact surface of the reusable sensor. Remove colored nail polish from the application site. Apply the sensor to the patient according to the instruction for use of the sensor. Select an appropriate extension cable according to the connector type and plug the cable into the SpO2 connector. Connect the sensor to the extension cable. 6. CAUTION Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct At elevated ambient temperatures, be careful with measurement sites that are not well perfused, circulation and lead to inaccurate measurements. because this can cause burns after prolonged application. 11 - 3 Avoid placing the sensor on extremities with an arterial catheter, an NIBP cuff or an intravascular venous infusion line. 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. 11.6 Changing the SpO2 Settings Changing the SpO2 Alarm Settings To change the SpO2 alarm settings, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties as desired. 4. NOTE The desat alarm is a high level alarm notifying you of potentially life threatening drops in oxygen saturation. When the SpO2 value is below the desat alarm limit and desat alarm switch is set on, the message SpO2 Desat is displayed. You can switch off the SpO2 Desat alarm only when the SpO2 Desat Alarm Off is enabled. For more information, see section 25.3.7.6Setting the Switch of the SpO2 Desat Alarm Off. Nellcor SatSecondsTM Alarm Management With traditional alarm management, high and low alarm limits are set for monitoring oxygen saturation. During monitoring, once an alarm limit is violated, an audible alarm immediately sounds. When the patient SpO2 fluctuates near an alarm limit, the alarm sounds each time the limit is violated. Such frequent alarms can be distracting. Nellcors SatSeconds alarm management technique is used to reduce these nuisance alarms. The SatSeconds feature is available with the Nellcor SpO2 to decrease the likelihood of false alarms caused by motion artifacts. With SatSeconds alarm management, high and low alarm limits are set in the same way as those with traditional alarm management. A SatSeconds limit is also set. The SatSeconds limit controls the amount of time that SpO2 saturation may be outside the set limits before an alarm sounds. The method of calculation is as follows: the percentage points of the SpO2 saturation falling outside the alarm limit is multiplied by the number of seconds remaining outside the limit. This can be stated as the equation:
SatSeconds = Points Seconds Only when the SatSeconds limit is reached, the monitor gives a SatSeconds alarm. For example, the figure below demonstrates the alarm response time with a SatSeconds limit set at 50 and a low SpO2 limit set at 90%. In this example, the patient SpO2 drops to 88% (2 points) and remains there for 2 seconds. Then it drops to 86% (4 points) for 3 seconds, and then to 84% (6 points) for 6 seconds. The resulting SatSeconds are:
% SpO2 Seconds SatSeconds 2 4 6 Total SatSeconds=
2=
3=
6=
4 12 36 52 11.6.1 11.6.2 11 - 4 After approximately 11 seconds, a Sat-Second alarm would sound, because the limit of 50 SatSeconds would have been exceeded.
%SpO2 Seconds Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient SpO2 may fluctuate above and below an alarm limit, re-entering the non-alarm range several times. During such fluctuation, the monitor integrates the number of SpO2 points, both positive and negative, until either the SatSeconds limit is reached, or the patient SpO2 re-enters the non-alarm range and remains there. NOTE The SpO2 Too Low or SpO2 Too High alarm is presented in the case that SpO2 value violates the alarm limits 3 times within one minute even if the setting of SatSeconds is not reached. To set the SatSeconds, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the Alarm tab. Set Sat-Seconds. 11.6.3 Setting SpO2 Sensitivity (for Masimo SpO2) For Masimo SpO2, selects the Sensitivity as per signal quality and patient motion. Normal sensitivity is the recommended for patients who are experiencing some compromise in blood flow or perfusion. It is advisable for care areas where patients are observed frequently, such as the intensive care unit
(ICU). Adaptive Probe Off Detection (APOD) sensitivity is the recommended sensitivity mode where there is a high probability of the sensor becoming detached. It is also the suggested mode for care areas where patients are not visually monitored continuously. This mode delivers enhanced protection against erroneous pulse rate and arterial oxygen saturation readings when a sensor becomes inadvertently detached from a patient due to excessive movement. Maximum sensitivity is recommended for use on patients with weak signals (e.g. high ambient noise and/or patients with very low perfusion) and for use during procedures or when clinician and patient contact is continuous such as in higher acuity settings.The settings of sensitivity in the SpO2 module and SpO2b module are linked. To set SpO2 sensitivity, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the SpO2 Setup tab. Set Sensitivity to Maximum, Normal, or APOD. 11 - 5 CAUTION When using the Maximum Sensitivity setting, performance of "Sensor Off" detection may be compromised. If the equipment and the sensor becomes detached from the patient, the potential for false readings may occur due to environmental noise such as light, and vibration. NOTE The settings of sensitivity in the SpO2 module and SpO2b module are linked. 11.6.4 Changing Averaging Time (for Masimo and Mindray SpO2) The SpO2 value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patients oxygen saturation level. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patients oxygen saturation level, but the SpO2 measurement is more stable. For critically ill patients, selecting a shorter averaging time will help with understanding the patients state. To set the averaging time, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the SpO2 Setup tab. Set Averaging. 11.6.5 Monitoring SpO2 and NIBP Simultaneously When monitoring SpO2 and NIBP on the same limb simultaneously, you can switch on NIBP Simul to lock the SpO2 alarm status until the NIBP measurement ends. If you switch off NIBP Simul, low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and therefore cause false physiological alarms. To set the NIBP Simul, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the Alarm tab. Set NIBP Simul. 11.6.6 Changing the Sweep Speed of the Pleth Wave To set the sweep speed of Pleth waveforms, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the SpO2 Setup tab. Set Speed. 11.7 Changing the PR Settings 11.7.1 Changing the PR Alarm Settings To change the PR alarm settings, follow this procedure:
1. 2. 3. 4. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the PR Alarm tab. Enter the password if required. For more information refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties as desired. 11 - 6 11.7.2 Changing the QRS Volume If the Alarm Source is set to PR, the QRS tone is derived from PR measurements. To set the QRS volume, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the PR Setup tab. Set QRS Volume. If the SpO2 value is valid, the monitor also adjusts the QRS tone (pitch tone) according to the SpO2 value. For information, see25.14.3Setting the SpO2 Tone Mode. NOTE Changing the QRS volume settings in the PR Setup page also changes the QRS volume settings in the Setup page of the ECG dialog. 11.7.3 Setting the PR Source Current pulse source is displayed in the PR numeric area if current PR source is not SpO2. The PR from current pulse source has the following characteristics:
PR is stored in the monitors database and can be reviewed in the graphic and tabular trends.In graphic trends, as the PR curve has the same color as that of current PR source. PR is sent via the network to the CMS, if available. To set which parameter is used as a PR source, follow this procedure:
1. 2. 3. Select the SpO2 numeric area or waveform area to enter the SpO2 dialog. Select the PR Setup tab. Set PR Source. The dropdown list of the PR Source displays the currently available PR sources from top to bottom by priority. When you select Auto, the system will automatically select the first option as the PR source. If the current PR source is unavailable, the system will automatically switch PR Source to Auto. When you select IBP, the system will automatically select the first pressure label as the PR source. 11.7.4 Showing/Hiding PR You can set whether to display the PR value in the SpO2 parameter area. To do so, follow this procedure:
1. 2. 3. 4. Select the SpO2 numeric area or waveform area to enter the SpO2 menu. Select the PR tab. Select the Setup tab. Switch on or off Display PR. 11.8 SpO2 Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. 11 - 7 Problem Do not see SpO2 numeric area or waveform area on the main screen Dashes - - display in place of numerics Low amplitude SpO2 signal SpO2 value is inaccurate 11.9 Masimo Information Solution 1. Check that the SpO2 is set to display in the Screen Setup Tile Layout page. For more information, see 3.9.2Displaying Parameter Numerics and Waveforms. 2. Check that the SpO2 parameter switch is enabled. If not, enable the SpO2 measurement.For more information, see 3.9.1Switching On or Off a Parameter. 3. Check that the cable connections of the SpO2 sensor and the extension cable are tight. Replace the SpO2 sensor or the extension cable if needed. 1. Check that the cable connections of SpO2 sensor and the extension cable are tight. Replace the SpO2 sensor or the extension cable if needed. 2. Reconnect the SpO2 sensor if the alarm SpO2 Sensor Off appears. 3. Check the PI value. If the PI value is too low, adjust the SpO2 sensor, or apply the sensor to a site with better perfusion. 4. Move the sensor to a place with weaker ambient light, or cover the sensor to minimize the ambient light if the alarm SpO2 Too Much Light appears. 1. The SpO2 sensor and NIBP cuff are placed on the same limb. Change the monitoring site if necessary. 2. Check the PI value. If the PI value is too low. Adjust the SpO2 sensor, or apply the sensor to a site with better perfusion. 1. Check the patients vital signs. 2. Check for conditions that may cause inaccurate SpO2 readings. For more information, see 11.3SpO2 Measurement Limitations. 3. Check the monitor, the SpO2 module or the MPM for proper functioning. Masimo Patents This posting serves as notice under 35 U.S.C.287(a) for Masimo patents: http://www.masimo.com/patents.htm. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. 11.10 Nellcor Information Nellcor Patents This posting serves as notice under 35 U.S.C.287(a) for Covidien patents: http://www.covidien.com/patents. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. 11 - 8 12 Monitoring Temperature (Temp) 12.1 Temperature Introduction The monitor can continuously monitor the patients skin temperature and core temperature. Thermally sensitive resistors (thermistors) are used, and are based on the principle that electrical resistance of the thermistor changes as temperature changes. The resistance change of the thermistors is used to calculate the temperature. Up to two temperature sites can be monitored simultaneously and the difference between two measured sites is calculated. Temperature monitoring is intended for adult, pediatric and neonatal patients. 12.2 Temperature Safety Information CAUTION Verify that the probe detection program works correctly before monitoring. Remove the temperature probe cable from the temperature probe connector, and check that the monitor can display the alarm messages and give alarm tones correctly. 12.3 Temperature Display The following figure shows the Temp numeric area for temperature monitoring with the MPM module or Temp module. Your display may be configured to look different.
(1)
(2)
(1)
(2)
(3)
(3)
(4)
(1) Temperature site
(2) Temperature alarm limits
(3) Temperature value
(4) Temperature difference (T): Difference between two temperature sites. It displays only when T is switched on. 12.4 Preparing for Temperature Monitoring To prepare temperature monitoring, follow this procedure:
1. 2. 3. Select an appropriate probe for your patient according to patient category and measured site. Plug the probe or temperature cable to the temperature connector. If using a disposable probe, connect the probe to the temperature cable. Follow the probe manufacturers instructions to connect the probe to the patient. 12 - 1 12.5 Changing Temperature Settings 12.5.1 Setting the Temperature Alarm Properties To set the temperature alarm properties, follow this procedure:
1. 2. 3. 4. Select the temperature numeric area to enter the Temp dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties as desired. 12.5.2 Selecting the Temperature Label Select the temperature label according to the measurement site. To do so, follow this procedure:
1. 2. 3. Select the temperature numeric area to enter the Temp dialog. Select the Setup tab. Set the temperature label. Label T1 T2 T skin T core T axil T naso T eso T rect Description Label Description Temperature of application site 1 T amb Ambient temperature Temperature of application site 2 T airw Skin temperature Core temperature Axillary temperature Nasopharyngeal temperature Esophageal temperature Rectal temperature T vesic T blood T myo T tymp T cereb Airway temperature Vesical temperature Blood temperature Myocardial temperature Tympanic temperature Cerebral temperature 12.5.3 Displaying the Temperature Difference To display the temperature difference between two measurement sites monitored by the same temperature module, switch on T. To do so, follow this procedure:
1. 2. 3. Select the temperature numeric area to enter the Temp dialog. Select the Setup tab. Switch on T. 12.6 Temperature Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. 12 - 2 Problem Solution Do not see Temp numeric area on the main screen 1. Check that if the Temp parameter switch is enabled. If not, enable the Temp measurement. For more information, see 3.9.1Switching On or Off a Parameter. 2. Check that the connections of the temperature probe and the temperature cable are tight. Measurement fails/-- is displayed in the Temp numeric area 1. If using a disposable probe, check the connection between the probe and the temperature cable. 2. Try using a known good probe in case the sensor is damaged. 12 - 3 13 Monitoring Noninvasive Blood Pressure (NIBP) 13.1 NIBP Introduction The monitor uses the oscillometric method for measuring Non-Invasive Blood Pressure (NIBP). NIBP measurement is based on the principle that pulsatile blood flow through an artery creates oscillations of the arterial wall. The oscillometric device uses a blood pressure cuff to sense these oscillations that appear as tiny pulsations in cuff pressure. The oscillometric devices measure the amplitude of pressure changes 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. The oscillometric method measures the mean pressure and determines the systolic and diastolic pressures. NIBP monitoring is intended for adult, pediatric, and neonatal patients. NOTE Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultatory method or an intra-arterial blood pressure measurement device, within the limits prescribed by the American National Standard: manual, electronic, or automated sphygmomanometers. NIBP measurement can be performed during electro-surgery and discharge of a defibrillator. 13.2 NIBP Safety Information WARNING Be sure to select the correct patient category setting for your patient before NIBP measurement. Do not apply the higher adult settings for pediatric or neonatal patients. Otherwise, it may present a safety hazard. Do not measure NIBP on patients with sickle-cell disease or on the limb where skin damage has Use clinical judgment to determine whether to perform frequent unattended blood pressure occurred or is expected. measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff. Do not use the NIBP 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. result in harmful injury to the patient. Do not apply cuff on the arm on the side of a mastectomy. Continuous cuff pressure due to connection tubing kinking may cause blood flow interference and NIBP reading can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic condition. If you doubt the NIBP measurements, determine the patients vital signs by alternative means, and then verify that the monitor is working correctly. Devices that exert pressure on tissue have been associated with purpura, ischemia, and neuropathy. 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. Auto NIBP measurements with one and two minute intervals are not recommended for extended periods of time. Do not modify or replace connectors of the NIBP air hose except with mindray-approved connectors. Use neonatal and infant cuffs with CM1901 hoses only. Use pediatric/adult cuffs with CM1903 hoses only. 13 - 1 Never connect intra-arterial or intra-venous lines, or any other incompatible connectors to the NIBP NIBP diagnostic significance must be decided by the hospitals clinician staff. hose. This can cause serious injury or death. CAUTION Only use parts and accessories specified in this manual. Follow the instructions for use and adhere to Accuracy of NIBP measurement depends on using a cuff of proper size. It is essential to measure limb all warnings and cautions. circumference and choose a cuff with proper size. 13.3 NIBP Measurement Limitations Measurements are impossible with heart rate extremes of less than 30 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible in the following situations:
Regular arterial pressure pulses are hard to detect Excessive and continuous patient movement such as shivering or convulsions Cardiac arrhythmias Rapid blood pressure changes Severe shock or hypothermia that reduces blood flow to the peripheries On an edematous extremity Obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery NOTE The effectiveness of this sphygmomanometer has not been established in pregnant women, including pre-eclamptic patients. 13.4 Measurement Modes There are three NIBP measurement modes:
Manual: measurement on demand. Auto: repeated measurements at set interval. STAT: continual rapid series of measurements over a five minute period. Sequence: continually automatic measurement at set durations and intervals. 13.5 NIBP Display The NIBP display shows only numerics.
(3) (4) (5)
(2)
(1) 13 - 2
(6)
(7)
(8)
(11)
(10) (9)
(1) Systolic pressure alarm limits
(2) NIBP unit: mmHg or kPa
(3) The last NIBP measurement time
(4) Time to the next measurement (for Auto mode and Sequence mode)
(5) Measurement mode: for Auto NIBP, interval is displayed; for Sequence mode, the current phase and interval are displayed
(6) Diastolic pressure
(7) Diastolic pressure alarm limit
(8) Mean pressure alarm limit
(9) Mean pressure (displayed after measurement completed) or cuff pressure (displayed during the measurement)
(10) Systolic pressure
(11) Pulse Rate If NIBP measurement fails, XX is displayed; if NIBP measurement is not taken or NIBP measurement exceeds its measurement ranges, -- is displayed. NOTE NIBP numerics in black color with a light outline indicate that the measurement is old and exceeds the configured NIBP Measurement Timeout time (see section 25.5.5Setting Parameter Measurement Timeout). These NIBP values are not recommended for reference. 13.6 Preparing for NIBP Measurements 13.6.1 Preparing the Patient for NIBP Measurements In normal use, perform NIBP measurement on a patient who is in the following position:
Comfortably seated Legs uncrossed Feet flat on the floor Back, arm and feet supported NOTE Other factors that have been shown to result in an overestimation of blood pressure are labored It is recommended that the patient remains calm and relaxes as much as possible before performing the measurement and that the patient does not talk during the measurement. breathing, full bladder, pain etc. 13.6.2 Placing the NIBP Cuff To place the NIBP cuff, follow this procedure:
1. 2. 3. Verify that the patient category setting is correct. Connect the air tubing to the NIBP connector on the MPM module. Select an appropriately sized cuff for the patient, and then wrap it around the limb directly over the patients skin as follows:
a b c Determine the patients limb circumference. Select an appropriate cuff by referring to the limb circumference marked on the cuff. The width of the cuff should be 40% (50% for neonates) of the limb circumference, or 2/3 of the length of the upper arm or the thigh. The inflatable part of the cuff should be long enough to encircle to overlap at least 50% to 80% of the limb. Apply the cuff to the patients upper arm or leg and make sure the marking on the cuff matches the artery location. The cuff should fit snugly, but with enough room for two fingers to be placed between the cuff and the patients arm (on adults), and loosely on neonates with little or no air present within the cuff. Otherwise it may cause discoloration and ischemia of the extremities. Make sure that the cuff index line falls within the range markings on the cuff. If it does not, use a cuff that fits better. 13 - 3 d Middle of the cuff should be at the level of the right atrium of the heart. If it is not, use the measurement correction formula to correct the measurement. For more information, see 13.8.7Setting the NIBP Display Format. 4. Connect the cuff to the air tubing. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing. CAUTION Do not touch or apply external pressure against the cuff and air tubing during NIBP measurement. Use care when placing the cuff on an extremity used for monitoring other patient parameters. This may cause inaccurate blood pressure values. 13.7 Starting and Stopping NIBP Measurements Start and stop NIBP measurement by selecting the NIBP quick keys or from the NIBP dialog. Task By Quick Key From NIBP dialog Start a manual measurement NIBP Start/Stop quick key Start NIBP button Start auto NIBP series NIBP Start/Stop quick key Setup tab set Interval Start NIBP button NIBP Measure quick key interval select Start NIBP sequence measurement NIBP Measure quick key Sequence Sequence tab set NIBP sequence Start NIBP button Start STAT measurement NIBP STAT quick key STAT button Stop the current NIBP measurements End auto NIBP series or NIBP Sequence Stop STAT measurement and end series NIBP Measure quick key STAT NIBP Start/Stop quick key Stop NIBP button Stop All quick key Stop All button NIBP Start/Stop quick key Stop NIBP or Stop All button NIBP STAT quick key 13.8 Changing NIBP Settings 13.8.1 Setting the NIBP Alarm Properties To set the NIBP alarm properties, follow this procedure:
1. 2. 3. 4. Select the NIBP numeric area to enter the NIBP dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties as desired. 13 - 4 13.8.2 Setting the Initial Cuff Inflation Pressure To set initial cuff inflation pressure, follow this procedure:
1. 2. Select the NIBP numeric area to enter the NIBP dialog. Select Initial Pressure, and then select the appropriate setting. NOTE For known hypertensive patients, you need to set initial cuff pressure to a higher value to reduce the measurement time. 13.8.3 Setting the NIBP Interval For auto NIBP measurement, you need to set the interval between two NIBP measurements. To set the NIBP interval, follow this procedure:
1. 2. Select the NIBP numeric area to enter the NIBP dialog. Set Interval. Selecting Manual switches to manual mode. NOTE NIBP Measure dialog gives quick access to starting and setting the interval. Selecting an option from the NIBP Measure dialog will change the NIBP interval to that selection and start the NIBP measurement. 13.8.4 Selecting NIBP Start Mode Start mode defines how NIBP auto mode works. To set the start mode, follow this procedure:
1. 2. Select the NIBP numeric area to enter the NIBP dialog. Set Start Mode. Clock: after the first measurement, the monitor automatically synchronizes NIBP automatic measurements with the real time clock. For example, if Interval is set to 20 min, and NIBP auto measurement is started at 14:03, the next measurement will be taken at 14:20, and then at 14:40, 15:00, and so on. Interval: after the first measurement, the monitor automatically repeats measurements at set interval. For example, if Interval is set to 20 min, and NIBP auto measurement is started at 14:03, the next measurement will be taken at 14:23, and then at 14:43, 15:03, and so on. 13.8.5 Enabling the NIBP End Tone The monitor can issue a reminder tone at the completion of NIBP measurement. The NIBP End Tone is off by default. To switch on the NIBP end tone, follow this procedure:
1. 2. Select the NIBP numeric area to enter the NIBP dialog. Switch on NIBP End Tone. 13.8.6 Setting NIBP Sequence NIBP sequence measurement can have up to five phases: A, B, C, D, and E. The duration and interval of each phase can be set individually. To set NIBP sequence, follow this procedure:
1. 2. 3. Select the NIBP numeric area to enter the NIBP dialog. Select the Sequence tab. Set Duration and Interval of each phase. 13 - 5 13.8.7 Setting the NIBP Display Format To set the NIBP display format, follow this procedure:
1. 2. 3. Select the NIBP numeric area to enter the NIBP menu. Select the Setup tab. Set Display Format. 13.8.8 Setting the NIBP Alarm Limits Display Switch To set whether to display the alarm limits of diastolic NIBP and mean NIBP, follow this procedure:
1. 2. 3. Select the NIBP numeric area to enter the NIBP menu. Select the Setup tab. Switch on or off Display Alarm Limits. 13.8.9 Showing/Hiding PR You can set whether to display the PR value in the NIBP parameter area. To do so, follow this procedure:
1. 2. 3. Select the NIBP numeric area to enter the NIBP menu. Select the Setup tab. Switch on or off Display PR. 13.8.10 Correcting the NIBP Measurements The middle of the cuff should be at the level of right atrium. If the limb is not at the heart level, the measurement should be corrected as follows:
Add 0.75 mmHg (0.10 kPa) to the displayed value for each centimetre higher. Deduct 0.75 mmHg (0.10 kPa) to the displayed value for each centimeter lower. 13.9 Assisting Venous Puncture You can use the NIBP cuff to cause sub-diastolic pressure to block the venous blood vessel and therefore help venous puncture. To assist venous puncture, follow this procedure:
1. 2. 3. 4. 5. Select the VeniPuncture quick key or select the NIBP numeric area Setup tab. Set Venipuncture pressure. Select VeniPuncture at the bottom of the dialog. Puncture vein and draw blood sample. Select the NIBP Start/Stop quick key to deflate the cuff. If the cuff is not manually deflated, the cuff automatically deflates after a fixed period of time (170 seconds for adult and pediatric patient, 85 seconds for neonatal patient). During venous puncture, pay attention to the cuff pressure and the remaining time displayed in the NIBP numerics area. 13.10 NIBP Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting for services. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. 13 - 6 Problem Solution Cannot see NIBP numeric area on the main screen 1. Check that the NIBP is set to display in the Screen Setup Tile Layout page. For more information, see.3.9.2Displaying Parameter Numerics and Waveforms 2. Check that if the NIBP parameter switch is enabled. If not, enable the NIBP measurement. For more information, see 3.9.1Switching On or Off a Parameter. 13 - 7 14 Monitoring Invasive Blood Pressure (IBP) 14.1 IBP Introduction IBP monitoring is intended for adult, pediatric, and neonatal patients. PAWP monitoring is only intended for adult and pediatric patients. You can monitor up to 4 (using the built-in IBP module and the external IBP module together) invasive blood pressures. The following picture shows the external IBP module.
(1) (2)
(3)
(3)
(1) IBP menu hard key
(2) Zero IBP hard key
(3) IBP cable connector 14.2 IBP Safety Information transducers. See chapter 29Accessories for specified pressure transducers. WARNING Use only pressure transducers specified in this manual. Never reuse disposable pressure Make sure that the applied parts never contact other conductive parts. To reduce the hazard of burns during high-frequency surgical procedures, ensure that the monitors cables and transducers never come into contact with the high-frequency surgical units. When using accessories, their operating temperature should be taken into consideration. For more All invasive procedures involve risks to the patient. Use aseptic technique. Follow catheter Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero balance and calibration, and cause erroneous readings. The neutral electrode of the electro-surgery unit (ESU) shall properly contact the patient. Otherwise, burns may result. information, see instructions for use of accessories. manufacturer's instructions. 14 - 1 14.3 Preparing for IBP Monitoring 14.3.1 IBP Equipment to Patient Connection
(1)
(5) m m H g
(2)
(3)
(4)
(5)
(1) Pressure bag/Infusion pump
(2) Monitor
(3) IBP cable
(5) Three-way valve
(4) IBP transducer 14.3.2 Measuring an Invasive Blood Pressure To monitor IBP, follow this procedure:
1. 2. 3. 4. 5. Connect one end of the IBP cable to the IBP cable connector, and the other end to the IBP transducer. Flush the IBP transducer system to exhaust all air from the tubing according to the manufacturers instructions. Ensure that the system is free of air bubbles. Connect the IBP transducer to the patient, making sure that the transducer is at the same horizontal level as the heart. Select the proper pressure label for currently measured pressure. For more information, see 14.6.2Changing the Pressure Label. Zero the IBP transducer. For more information, see.14.3.3Zeroing the IBP transducer. After a successful zeroing, turn off the three-way valve to the air and turn on the three-way valve to the patient. CAUTION Make sure that all the transducers are zeroed correctly before making IBP measurements. Make sure that all air bubbles have been flushed from the IBP transducer system before making IBP measurements. If measuring intracranial pressure (ICP) with a sitting patient, level the transducer with the top of the patients ear. Incorrect leveling may give incorrect values (not applicable if measuring ICP with the Codman ICP transducer). 14 - 2 14.3.3 Zeroing the IBP transducer To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with your hospital policy. The IBP transducer should be zeroed in the following conditions:
The IBP transducer, adapter cable or module is reconnected. The monitor restarts. The readings are in doubt. The monitor displays the prompt message Zero Required. To zero the transducer, follow this procedure:
1. 2. 3. 4. Connect the IBP transducer, the IBP adapter cable and the module. Turn off the three-way valve (the one near the transducer) to the patient, in order to vent the transducer to the atmospheric pressure. Zero the transducer by one of the following methods:
Press the Zero hard key on the module. In the Zero IBP dialog, select to zero an IBP, or select to zero all IBP. Select the numeric area (such as the Art numeric area), and then select Zero button. Select the IBP Zero quick key. In the Zero IBP dialog, select to zero an IBP, or select to zero all IBP. After the zero calibration is completed, close the three-way valve to the air and open the three-way valve to the patient. Zero calibration may fail in case of pressure fluctuation or pressure exceeding the calibration range. If zero calibration fails, follow this procedure:
1. 2. Check that the three-way valve (the one near the transducer) is open to the air. Perform zero calibration again. Do not sway the IBP transducer and tubing during zero calibration. 14.4 Measuring ICP Using the Codman ICP Transducer 14.4.1 Zeroing the Codman ICP transducer The Codman ICP transducer (Model: 82-6653) must be zeroed before use. To zero the ICP transducer, follow this procedure:
1. 2. 3. 4. Connect the ICP transducer, the ICP adapter cable and the module. Follow the manufacturers instructions to prepare the ICP transducer. Zero the ICP transducer: when the message Zero Reference is displayed in the ICP numeric area, select the ICP waveform area or numeric area to enter the ICP dialog select the Zero tab select the Zero button. Record the zero reference value on the blank area of the ICP transducer for reference. If the ICP transducer zero calibration failed or the zero reference value is in doubt, perform the zero calibration again. 14.4.2 Measuring ICP To perform the ICP measurement, follow this procedure:
1. 2. 3. 4. Zero the Codman ICP transducer. For more information, see section 14.4.1Zeroing the Codman ICP transducer. Disconnect the ICP transducer and ICP adapter cable. Follow the manufacturers instructions to apply the ICP transducer to the patient. Reconnect the ICP transducer and ICP adapter cable. Check that the zero reference value displayed on the monitor is consistent with that recorded on the ICP transducer. Consistent: select Accept. Inconsistent: input the zero reference value recorded on the ICP transducer, and select Accept. 14 - 3 If the patient being monitored for ICP must be transported, check that the target monitor supports the Codman ICP transducer. For more information, see 14.4.1Zeroing the Codman ICP transducer. If the target monitor does not support the Codman ICP transducer, do not use it for ICP monitoring. If the target monitor supports the Codman ICP transducer, follow this procedure to transport the patient:
1. 2. 3. Disconnect the ICP adapter cable from the measurement module, or remove the module from the monitor. Connect the ICP adapter cable, measurement module, and the target monitor, or insert the measurement module into the target monitor. Check that the zero reference value displayed on the monitor is consistent with that recorded on the ICP transducer. Consistent: select Accept. Inconsistent: input the zero reference value recorded on the ICP transducer, and select Accept. CAUTION If monitors of different brands are used to zero the Codman ICP transducer, the zero reference values can be different. Use a Mindray monitor to Zero the Codman ICP transducer if you will take ICP measurement using a Mindray monitor. Otherwise the ICP measurement could be inaccurate. 14.5 IBP Display The IBP measurement is displayed on the monitor as a waveform and numeric pressures. For arterial pressure, the IBP numeric area displays systolic pressure, diastolic pressure and mean pressure. For venous pressure, the IBP numeric area displays only the mean pressure. The figure below shows the waveform and numerics for the Art pressure.
(1) (2) (3) (4) (5)
(7) (6)
(1) Pressure label
(3) Pressure Unit
(5) Diastolic pressure
(7) PPV measurement
(2) Waveform
(4) Systolic pressure
(6) Mean pressure For some pressures, the parameter window may show the mean pressure only. For different pressures, their defaults unit may be different. If the Art and ICP pressures are measured simultaneously, the ICP parameter area will display numeric CPP, which is obtained by subtracting ICP from the Art mean. 14.5.1 Overlapping IBP Waveforms The IBP waveforms can be displayed together. To combine IBP waveforms, follow this procedure:
1. 2. 3. 4. Access Tile Layout by either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select Main Menu quick key from the Display column select Tile Layout. Select the waveform area where you want to display the overlapped IBP waveforms, and then select the IBP waves to be overlapped on the left side of the same line. Repeat step 2 in another waveform area if needed. Select to save the setting and exit the screen. The main screen will display the overlapped IBP waves. 14 - 4 Selecting the overlapped IBP waveforms on the main screen opens the Overlapping Waveform Setup dialog, where you can make the following settings:
Scale Set Left Scale for the arterial pressure. Set Right Scale for the venous pressure. Set CVP Scale individually if the CVP waveform is combined and CVP unit is different from IBP unit. Set ICP Scale individually if the ICP waveform is combined and ICP unit is different from IBP unit. Set PA Scale individually if the PA waveform is combined. Switch on or off Gridlines to show or hide gridlines in the overlapped waveform area. Set Speed for the overlapped waveforms. NOTE The unit of CVP scale is consistent with the CVP parameter unit. 14.6 Changing IBP Settings 14.6.1 Changing the IBP Alarm Settings To change the IBP alarm settings, follow this procedure:
1. 2. 3. 4. Select the IBP numeric area or waveform area to enter the corresponding pressure dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties of pressure. 14.6.2 Changing the Pressure Label The pressure label is a unique identifier for each type of pressure. Therefore, it is recommended to select the proper pressure label for the source of the pressure being monitored. To select the pressure label, follow this procedure:
1. 2. 3. Select the IBP numeric area or waveform area to enter the corresponding pressure dialog. Select the Setup tab. Set IBP1 Label or IBP2 Label. Label Description Label Description Art Ao BAP CVP RAP UVP Arterial blood pressure Aortic pressure Brachial arterial pressure Central venous pressure Right atrial pressure Umbilical venous pressure PA UAP FAP LAP ICP LV Pulmonary artery pressure Umbilical arterial pressure Femoral arterial pressure Left atrial pressure Intracranial pressure Left ventricular pressure P1 to P4 Non-specific pressure label 14 - 5 NOTE The same label cannot be selected for different pressures. When two pressures are detected having the same label, the monitor automatically changes one pressure label to a currently unused one. 14.6.3 Setting the Pressure Type for Display For the non-specific pressure (P1, P2, P3 or P4), the displayed pressure type is configurable. To set the displayed pressure type, follow this procedure:
1. 2. 3. Select the numeric area or waveform area of the non-specific pressure to enter the corresponding pressure dialog. Select the Setup tab. Set Measure:
If this non-specific pressure is arterial pressure, set the Measure to All. In this case, its corresponding numeric area displays systolic pressure, diastolic pressure and mean pressure. If this non-specific pressure is venous pressure, set the Measure to Mean Only. In this case, its corresponding numeric area displays only the mean pressure. 14.6.4 Changing the Sensitivity The IBP value displayed on the monitor screen is the average of data collected within a specific time. The shorter the averaging time is, the quicker the monitor responds to changes in the patients blood pressure, and the higher the sensitivity. Contrarily, the longer the averaging time is, the slower the monitor responds to changes in the patients blood pressure, the lower the sensitivity, but the measurement accuracy will be improved. For critically ill patients, selecting higher sensitivity will help with understanding the patients state. To set the sensitivity, follow this procedure:
1. 2. 3. Select the IBP numeric area or waveform area to enter the corresponding pressure dialog. Select the Setup tab. Set Sensitivity. 14.6.5 Setting the IBP Waveform To set the IBP waveform, follow this procedure:
1. 2. 3. Select the IBP numeric area or waveform area to enter the corresponding pressure dialog. Select the Setup tab. Set the following properties of the IBP waveform:
Speed Scale: if Auto is selected, the size of the pressures waveform will be adjusted automatically. 14.6.6 Setting the Display Format of Artery Pressure To set the display format of the artery pressure, follow this procedure:
1. 2. 3. Select the numeric area or waveform area of any arterial pressure to enter the corresponding menu. Select the Setup tab. Set Display Format. 14.6.7 Showing/Hiding the Alarm Limits of Artery Pressure To set whether to display the alarm limits of the arterial pressure, follow this procedure:
1. 2. 3. Select the numeric area or waveform area of any arterial pressure to enter the corresponding menu. Select the Setup tab. Switch on or off Display Alarm Limits. 14 - 6 14.6.8 Setting the Use PA-D as PAWP Switch The PA-D value can be configured to replace the PAWP value for hemodynamic calculation. To do so, follow this procedure:
1. 2. 3. Select the PA numeric area or waveform area to enter the PA dialog. Select the Setup tab. Switch on or off Use PA-D as PAWP. For more information on hemodynamic calculation, see 20.4Hemodynamic Calculations. 14.6.9 Enabling PPV Measurement PPV indicates pulse pressure variation. When measuring the arterial pressure (except PA), the PPV measurement is available. To enable the PPV measurement, follow this procedure:
1. 2. 3. Select the IBP numeric area or waveform area to enter the corresponding pressure dialog. Select the PPV Setup tab. Switch on PPV Measure. You can select PPV source after enabling the PPV measurement. WARNING This monitor can calculate PPV from beat-to-beat values of any arterial pulsatile pressure. The circumstances under which the calculation of a PPV value is clinically meaningful, appropriate and reliable must be determined by a physician. The clinical value of the derived PPV information must be determined by a physician. According to recent scientific literature, the clinical relevance of PPV information is restricted to sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. PPV calculation may lead to inaccurate values in the following situations:
at respiration rates below 8 rpm during ventilation with tidal volumes lower than 8 ml/kg for patients with acute right ventricular dysfunction (cor pulmonale). The PPV measurement has been validated only for adult patients. 14.7 PAWP Pulmonary Artery Wedge Pressure (PAWP) values, used to assess cardiac function, are affected by fluid status, myocardial contractility, and valve and pulmonary circulation integrity. Obtain the measurement by introducing a balloon-tipped pulmonary artery flotation catheter into the pulmonary artery. When the catheter is in one of the smaller pulmonary arteries, the inflated balloon occludes the artery allowing the monitor to record changes in the intrathoracic pressures that occur throughout the respiration cycle. The pulmonary wedge pressure is the left ventricular end diastolic pressure when the airway pressure and valve function are normal. The most accurate PAWP values are obtained at the end of the respiration cycle when the intrathoracic pressure is fairly constant and the artifact caused by respiration is minimal. WARNING PAWP monitoring is not intended for neonatal patients. 14 - 7 14.7.1 PAWP Equipment to Patient Connection
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(2)
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(6)
(8)
(3)
(4)
(5)
(1) MPM/IBP module
(3) IBP transducer
(5) PA distal port
(2) Flush bag
(4) Three-way valve
(6) Balloon inflation syringe
(7) Thermodilution catheter
(8) Balloon 14.7.2 Preparing to Measure PAWP To prepare to monitor PAWP, follow this procedure:
1. 2. 3. 4. Connect the IBP transducer, the IBP cable and the module. For more information, see 14.3.2Measuring an Invasive Blood Pressure. Follow the manufacturers instructions to connect the PA port of the thermodilution catheter and the patient end of the IBP transducer. Zero the IBP transducer. For more information, see 14.3.3Zeroing the IBP transducer. Set the IBP label to PA since the PAWP is measured on PA. For more information, see 14.6.2Changing the Pressure Label. 14.7.3 Measuring PAWP To measure the PAWP, follow this procedure:
1. Select the PA numeric area or waveform area to enter the PA dialog, and then select PAWP. 14 - 8 2. Wedge the flotation catheter into the pulmonary artery by observing the PA waveform changes on the screen, referring to the following figure. 3. 4. 5. 6. 7. Select Start. Inflate the balloon and pay attention to PA waveform changes on the screen when the prompt message Ready For Balloon Deflation appears. Deflate the balloon when the prompt message Ready For Balloon Deflation appears. If the PA waveform is stable, but the monitor is still not showing the prompt message Ready For Balloon Deflation, select Freeze to freeze the waveform, and deflate the balloon. Select Accept to save the PAWP value. If you need to start a new measurement, repeat step 3 to step 6. If the measurement fails or you need to adjust the PAWP value, you can use the following buttons to adjust the PAWP waveform and measurement. Select the up or down arrow button to adjust the PAWP value. Select the left or right arrow button to view the frozen waveforms of 40 seconds. Select Accept to save the PAWP value. 14 - 9 WARNING Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement. If the PAWP is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy. Because the pulmonary artery could be accidentally ruptured, and the PAWP value derived will not reflect the patients hemodynamic state, but will merely reflect the pressure in the catheter or balloon. If the flotation/thermodilution catheter drifts into the wedge position without inflation of the balloon, the PA waveform assumes a wedged appearance. Take appropriate action, in accordance with standard procedures, to correct the situation. NOTE The PA alarm is turned off automatically when the monitor enters the PAWP screen. 14.7.4 Setting the Waveforms of the PAWP Screen On the PAWP screen, select Setup to enter the PAWP Setup dialog. In the PAWP Setup dialog, you can make the following settings:
Select Reference Waveform 1 to set an ECG lead wave as the first reference wave. Select Reference Waveform 2 to set a respiration wave as the second reference wave. Select Speed to set a sweep speed for the displayed waveforms on the PAWP screen. Select Scale to set the size of the PA waveform on the PAWP screen. 14.7.5 14.8 Performing Hemodynamic Calculation On the PAWP screen, select Hemo Calcs to enter the Calculations dialog. For more information, see 20.4Hemodynamic Calculations. Connecting a Camino Device The IBP module can interface with the Camino multi-parameter monitor (Model: MPM-1) to measure intracranial pressure (ICP). To connect the Camino, follow this procedure:
1. 2. 3. 4. Plug the IBP module into the module rack. Connect the Camino ICP cable to the IBP module. Connect the ICP connector to the ICP adapter. Connect the Camino cable to the Camino monitor.
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(2)
(3)
(4)
(5)
(6) 14 - 10
(1) External IBP module
(3) ICP adapter
(5) Camino cable
(2) Camino ICP cable
(4) ICP connector
(6) Camino monitor WARNING Refer to the Camino Operators Manual to adjust settings and connect the monitor with the patient. ICP alarm settings on the Mindray patient monitor are independent of the Camino monitor alarm settings, and thus may be different. Please pay special attention to the alarms on the Camino monitor. 14.9 IBP Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. Problem Solution Cannot see IBP numeric area or waveform area on the main screen 1. Check that the IBP is set to display in the Screen Setup dialog. For more information, see.3.9.2Displaying Parameter Numerics and Waveforms. 2. Check that if the IBP parameter switch is enabled. If not, enable the IBP measurement. For more information, see 3.9.1Switching On or Off a Parameter. 3. Check the connection of IBP cable, IBP transducer and the monitor. 4. Check that the three-way valve is turned to the correct position. 5. Check that the IBP transducer has been zeroed. For more information, see 14.3.3Zeroing the IBP transducer. Cannot see systolic pressure and diastolic pressure for P1/P2/P3/P4 Set Measure to All in the P1/P2/P3/P4 setup page. For more information, see 14.6.3Setting the Pressure Type for Display. IBP readings seem unstable Zeroing of IBP channel(s) fails. 1. Make sure there are no air bubbles in the transducer systems. 2. Check that the transducer is properly fixed. 3. Zero the transducer again. 4. Replace the transducer. 1. Ensure that the channels are open to air. 2. Perform zero calibration again. Do not sway the IBP transducer and tubing during zero calibration. For more information, see 14.3.3Zeroing the IBP transducer. If zero calibration still fails, replace the transducer. 3. 14 - 11 15 Monitoring Cardiac Output (C.O.) 15.1 C.O. Introduction The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using the right heart (atria) thermodilution method. A cold solution of known volume and temperature is injected into the right atrium through the proximal port of a pulmonary artery (PA) catheter. The cold solution mixes with the blood in the right ventricle and the change in blood temperature is measured with a thermistor at the distal end of the catheter in the pulmonary artery. The temperature change is displayed as a curve on the C.O. split screen, and the monitor calculates the C.O. value from this curve. The C.O. value is inversely proportional to the area under the curve. As cardiac output varies continuously, a series of measurements must be carried out to achieve a reliable C.O. average value. Always use the average of multiple thermodilution measurements for therapy decisions. The monitor is capable of storing 6 measurements. C.O. monitoring is intended for adult patients only. You can monitor C.O. using the built-in C.O. module or the external C.O. module. The following picture shows the external C.O. module.
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(2)
(3)
(1) C.O. menu hard key
(2) C.O. measure menu hard key
(3) C.O. cable connector 15.2 C.O. Safety Information The C.O. measurement results may be erroneous during electrosurgery. WARNING All invasive procedures involve risks to the patient. Use aseptic technique and follow catheter Use only accessories specified in this manual. Make sure that the accessories never come into C.O. monitoring is not intended for pediatric and neonatal patients. contact with conductive parts. manufacturer's instructions. 15 - 1 15.3 C.O. Measurement Limitations The following factors may influence the accuracy of C.O. measurement:
temperature of injectate solution volume of injectate solution baseline of patients blood temperature patients inspiratory/expiratory cycle placement of catheter with relation to proximity of lung field the catheter itself patients heart rate and hemodynamic status any solution infused with intravenous injection during the C.O. measurement To obtain accurate C.O. measurements, follow these recommendations:
Temperature of injectate solution must be at least 10 C cooler than that of the patients blood. Inject solution at end of expiration. Inject solution rapidly and smoothly. Finish injection within four to five seconds. 15.4 C.O. Display The C.O. display shows only C.O., C.I. (cardiac index), and TB (blood temperature) in the C.O. numeric area.
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(2)
(3)
(4)
(1) C.O. label
(3)Primary parameter
(2) Primary parameter unit
(4) Secondary parameter NOTE The C.O. value is invalid if it is displayed in outline font. 15 - 2 15.5 C.O. Equipment to Patient Connection
(1) Monitor
(2) 12-pin C.O. cable (Model: CO7702)
(3) TI cable connector
(4) In-line probe
(5) Injectate solution
(6) Injectate syringe
(7) Three-way valve
(8) Proximal injectate port
(9) Balloon inflation valve
(10) Thermistor connector
(11) PA distal port
(12) Thermodilution catheter
(13) Thermistor 15.6 Performing C.O. Measurement 15.6.1 Preparing for C.O. Measurement 1. Connect the C.O. cable to the C.O. module and thermistor connector, making sure the C.O. numeric area is displayed on the monitors main screen. Follow the hospitals policy and procedures to prepare the patient for the C.O. measurement. Follow the manufacturers instructions to set up the catheter and other accessories. Check that all the accessories are properly connected. 2. 3. 4. NOTE For an in-line probe setup, make sure the in-line sensor is securely connected to the tubing. For the bath probe setup, make sure the bath probe is correctly sensing the injectate temperature. 15.6.2 Setting C.O. Measurement Before performing the C.O. measurement, follow this procedure:
1. 2. 3. Select the C.O. numeric area to enter the C.O. Measure dialog. Select the Setup. Perform the following check or setup:
Check if the height and weight are appropriate for your patient. Change if necessary. The patient's height and weight values are required for determining cardiac index (C.I.). Check that the correct computation constant is entered. The computation constant has a close relationship with the entered injectate volume, injectate probe type (in-line probe or bath probe) and temperature. See the Instructions for Use of the pulmonary artery catheter to determine correctness. 15 - 3 To change the computation constant, select Comp Const and then input the correct value. When a new catheter is used, the computation constant should be adjusted in accordance with the manufacturers instructions for use. Switch on or off Auto TI. If Auto TI is switched on, the system automatically detects the injectate temperature, and TI setting is disabled. If Auto TI is switched off, you need to input the injectate temperature at TI. Switch on or off Auto Start. If Auto Start is switched on, the monitor automatically takes the C.O. measurement after establishing a baseline of blood temperature. If Auto Start is switched off, you need to click the Start button in the C.O. Measure dialog for a new measurement. 15.6.3 Performing C.O. Measurement To perform the C.O. measurement, follow this procedure:
1. Select the C.O. numeric area to enter the C.O. Measure dialog.
(1)
(2)
(4)
(5)
(6)
(3)
(1) Average values
(2) Historical measurement dialogs
(3) Current measurement values
(4) Current C.O. curve
(5) Prompt message area
(6) Buttons 2. 3. Proceed as follows to perform the C.O. measure:
If Auto Start is switched off, select the Start button, and then inject the solution quickly when you see the message Please Wait. As shown in the figure above, during the measurement, the currently measured thermodilution curve is displayed. At the end of the measurement, the thermodilution curve is transferred to one of the 6 measurement areas and the monitor prompts you to wait for a certain period of time before starting a new measurement. If Auto Start is switched on, inject the solution quickly when you see the message Ready for new set of measurement. The monitor consecutively takes C.O. measurements automatically without the need for pressing the Start button between two measurements. A new thermodilution measurement is possible as soon as the message Inject now! is displayed on the screen. The monitor automatically detects further thermodilution measurements. Acquire the average value of C.O. and C.I. A maximum of 6 measurements can be stored. If you perform more than six measurements without rejecting any, the oldest will automatically be deleted when a seventh curve is stored. Select from the 6 measurement curves and the system will automatically calculate and display the averaged C.O. and C.I. values. Then select the Accept Average button to accept and store the averaged values. When injecting, the stopcock to the thermodilution catheter is open and the stopcock to the injectate solution is closed. After completing the measurement, turn off the stopcock to the thermodilution catheter and turn on the stopcock to the injectate solution, and then draw the injectate solution into the injectate syringe. 15 - 4 The button area also provides you with the following functions:
Select Stop to stop the current measurement. Select Setup to enter the C.O. dialog. Select Hemo Calcs to enter the Calculations dialog. NOTE Starting a measurement without blood temperature being stable may cause measurement failure. The TB alarms are inactivated during a C.O. measurement, and will be reactivated automatically after the completion of C.O. measurement. Please see the Instructions for Use of thermodilution catheter to determine the Comp Const and the volume of injectate solution. 15.7 Changing C.O. Settings 15.7.1 Setting C.O. Alarm Properties To set the C.O. alarm properties, follow this procedure:
1. 2. 3. 4. 5. Select the C.O. numeric area to enter the C.O. Measure dialog. Select Setup to enter the C.O. dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set the alarm properties as desired. 15.8 C.O. Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, the table below may help with troubleshooting before requesting a service personnel visit. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. Problem Solution Do not see C.O. numeric area on the main screen C.O. value is inaccurate 1. Check that the C.O. is set to display in the Screen Setup dialog. For more information, see 3.9.2Displaying Parameter Numerics and Waveforms. 2. Check that if the C.O. parameter switch is enabled. If not, enable the C.O. measurement. For more information, see 3.9.1Switching On or Off a Parameter. 3.Check that the patient type is adult. 4. Check the connection of C.O. cable, thermodilution catheter and TI sensor. 1. Check that the thermodilution catheter is positioned properly. 2. Check that the computational constant is proper for current injectate temperature, injectate volume and injectate probe type. 3. Inject solution rapidly and smoothly. 4. Finish injection within four to five seconds. 5. Inject more volume, or inject colder solution. 6. Check that the height and weight of patient is properly configured. 7. If Auto TI is switched off, check that the entered temperature is correct. 15 - 5 Problem C.O. measurement fails Solution 1. Inject more volume, or inject colder solution. Make sure that the injectate temperature is at least 10C colder than the patient blood temperature. 2. Finish injection within four to five seconds. 3. Check the connection of C.O. cable, thermodilution catheter and TI sensor. 15 - 6 16 Monitoring Carbon Dioxide (CO2) 16.1 CO2 Introduction CO2 monitoring is a continuous, non-invasive technique for determining the concentration of CO2 in the patients airway by measuring the absorption of infrared (IR) light of specific wavelengths. CO2 has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO2. When a specific band of IR light passes through respiratory gas samples, some of IR light will be absorbed by the CO2 molecules. The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector. From the amount of IR light measured, the concentration of CO2 is calculated. CO2 measurement is used to monitor the patients respiratory status. The following two methods are used for measuring CO2:
Mainstream CO2 measurement Directly insert a CO2 sensor into the patient's breathing system. Sidestream/Microstream CO2 measurement Take a sample of the respiratory gas with a constant sample flow from the patient's airway and analyzes it with a remote CO2 sensor built into the Sidestream or Microstream CO2 module. The sidestream CO2 module can be configured with a paramagnetic oxygen sensor to measure O2. The paramagnetic oxygen sensor measures oxygen based on its paramagnetic properties. The mainstream CO2 measurement can be used, with specified accessories, with intubated adult, pediatric and neonatal patients. The sidestream and microstream CO2 measurement can be used, with specified accessories, with intubated and non-intubated adult, pediatric, 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 line. With non-intubated patients, the gas sample is drawn through a nasal cannula. CO2 monitoring is intended for adult, pediatric and neonatal patients. 16.2 Identifying CO2 Modules For ePM 12M/ePM 15M, you can monitor CO2 using the built-in CO2module or the external CO2 module. For ePM 10M, you can monitor CO2 using the external CO2 module only. The following external modules are sidestream CO2 module, microstream CO2 module and mainstream CO2 module from left to right.
(1)
(2)
(1)
(2)
(1)
(3)
(4)
(4)
(5)
(1) CO2 menu hard key
(3) CO2 watertrap seat
(5) Sample line connector
(2) CO2 Measure/standby hard key
(4) Gas outlet
(6) CO2 sensor connector
(2)
(6) 16 - 1 To measure CO2 using the AG module, see 17Monitoring Anesthetic Gas (AG). 16.3 CO2 Safety Information WARNING Route all tubing away from the patients throat to avoid strangulation. Shaking the CO2 module during O2 measurement may lead to a distorted O2 waveform or inaccurate O2 measurement CAUTION Remove the airway sample line from the patients airway while nebulized medications are being Avoid mechanical shock to the sidestream CO2 module. delivered. Measuring CO2 during nebulization may lead to inaccurate CO2 readings. EtCO2 values measured from the CO2 module may differ from those from the blood gas analysis. NOTE The CO2 module automatically suppresses physiological alarms until breathing waves have been detected. Ensure that the patient is properly connected when using the CO2 module. 16.4 CO2 Measurement Limitations The following factors may influence the measurement accuracy:
Leaks or internal venting of sampled gas Mechanical shock Cyclic pressure up to 10 kPa (100 cmH2O) Other sources of interference, if any For more information, refer to A.13.9CO2 Specifications. CAUTION Measurement accuracy of the sidestream CO2 module may be affected by the breath rate and Measurement accuracy of the microstream CO2 module may be affected by the breath rate. inspiration/expiration (I/E) ratio. 16.5 CO2 Display The CO2 numeric and waveform areas provide FiCO2 measurement, EtCO2 measurement, awRR measurement, and a CO2 waveform.
(1)
(2)
(3)
(4)
(1) CO2 waveform
(2) Fraction of inspired CO2 (FiCO2)
(3) End tidal CO2 value (EtCO2)
(4) Airway respiration rate (awRR) 16 - 2 If the sidestream CO2 module is configured with the oxygen sensor, O2 waveform and parameters can be displayed in an O2 numeric and waveform area as follows:
(3)
(2)
(1)
(1) O2 waveform
(2) FiO2 measurement
(3) EtO2 measurement 16.6 Measuring CO2 Using the Sidestream/Microstream CO2 Module 16.6.1 Preparing to Measure CO2 Using the Sidestream CO2 Module To prepare the CO2 module for measurement, follow this procedure:
1. 2. Select the appropriate gas sample line and watertrap according to the patient category. Connect the watertrap to the CO2 module, and connect the gas sample line to the watertrap.
(1)
(2)
(3)
(1) Watertrap receptacle
(2) DRYLINE II watertrap
(3) Gas sample line 3. Connect the other end of the gas sample line to the patient. For intubated patients requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece.
(1)
(3)
(4)
(2)
(1) Sample line
(3) Airway adapter
(2) Connection to the ventilator
(4) Connection to the patient 16 - 3 For non-intubated patients, place the nasal cannula onto the patient. 4. Connect the gas outlet to the scavenging system using an exhaust tube. After the CO2 module is connected, it enters measure mode by default and the monitor displays CO2 Starting. CO2 can be measured after the start-up sequence is complete. WARNING Do not use the adult or pediatric watertrap with a neonate patient. Otherwise, patient injury could Connect the gas outlet to the scavenging system when measuring CO2 using the sidestream CO2 result. module. CAUTION Leakage in the breathing or sampling system may cause the displayed EtCO2 values to be significantly low. Always make sure that all components are securely connected. Inspect the airway adapter for a tight connection and proper operation before attaching it to the patient. Squeezing or bending the sample line during sidestream or microstream CO2 measurement may cause inaccurate CO2 readings or no reading. To avoid blocking the airway, empty the DRYLINE II watertrap container whenever half full. Replacing the DRYLINE II watertrap once a month is recommended. The DRYLINE II watertrap has a filter preventing bacterium, water and secretions from entering the module. Extended use could destroy the filter in watertrap and fail to stop the bacterium, water and secretions entering the module, result in damaging the gas module and having infection risk. NOTE To extend the lifetime of the watertrap and module, disconnect the watertrap from the module and set the operating mode to Standby mode when CO2 monitoring is not required. The sample rates are different when different types of watertraps are used. The emptying interval of the DRYLINE II adult/pediatric watertrap is 26 hours @ 120 ml/min, 37 C, and 100% RH. The emptying interval of the DRYLINE II neonatal watertrap is 35 hours @ 90 ml/min, 37 C, and 100% RH. 16 - 4 16.6.2 Preparing to Measure CO2 Using the Microstream CO2 Module To prepare the CO2 module for measurement, follow this procedure:
1. Connect one end of the sample line to the microstream CO2 module. 2.
(1)
(2)
(1) Sample line connector
(2) Sample line Connect the other end of the sample line to the patient. For intubated patient requiring an airway adapter, install the airway adapter between the patient circuit and the ventilator Y-piece. For non-intubated patient, place the nasal cannula onto the patient. For patient prone to mouth breathing, place the oral-nasal cannula onto the patient. 3. Connect the gas outlet to the a scavenging system using an exhaust tube. After the CO2 module is connected to the SMR, it enters measure mode by default and the monitor displays CO2 Sensor Warmup. CO2 can be measured after the start-up sequence is complete. WARNING Connect the gas outlet to the scavenging system when measuring CO2 using the microstream CO2 module. NOTE Disconnect the sample line from the module when CO2 monitoring is not required. 16.6.3 Zeroing the Sidestream/Microstream CO2 Module The sidestream or microstream CO2 module performs zero calibration automatically when needed. NOTE The CO2 module temporally stops measuring during zeroing. 16 - 5 16.7 Measuring CO2 Using Mainstream CO2 Module 16.7.1 Preparing to Measure CO2 Using Mainstream CO2 Module To prepare the CO2 module for measurement, follow this procedure:
1. Connect the airway adapter to the sensor head.
(2)
(1)
(3)
(1) Sensor
(2) Connect to module
(3) Airway adapter 2. 3. 4. Attach the sensor connector to the CO2 connector on the mainstream CO2 module. Zero the sensor after the warm-up is finished. For details, see 16.7.2Zeroing the Mainstream CO2 sensor. After the zero calibration is finished, connect the airway as shown below.
(5)
(4)
(4) Connect to patient
(5) Connect to ventilator 5. Make sure that no leakages are in the airway and then start a measurement. settings will result in erroneous CO2 reading. NOTE Be sure to set the barometric pressure properly before using the mainstream CO2 module. Improper Always position the sensor with the adapter in an upright position to avoid collection of fluids in the windows of the adapter. Large concentrations of fluids at this point will obstruct gas analysis. To avoid dead space, place the sensor as close to the patient as possible. 16 - 6 16.7.2 Zeroing the Mainstream CO2 sensor For mainstream CO2 modules, the sensor should be zeroed in the following conditions:
Before each measurement. A new adapter is used. Reconnect the sensor to the module. The message CO2 Zero Required displays. In this case, check the airway adapter for any blockage, e.g. mucus, etc. If a blockage is detected, clear or replace the adapter. To zero the sensor, follow this procedure:
1. 2. 3. 4. 5. Connect the sensor to the module. In the CO2 menu, select Setup tab. Set the Operating Mode to Measure. The message CO2 Sensor Warmup is displayed. After warm-up is finished, connect the sensor to a clean, dry airway adapter. The adapter should be vented to the air and isolated from CO2 sources, such as ventilator, the patients breathing, your own breathing, etc. Select Zero in the CO2 menu. The message Zeroing is displayed. It takes about 15 to 20 seconds. The message disappears when the zero calibration is completed. WARNING When perform a zero calibration during the measurement, disconnect the sensor from the patients airway first. Please do not rely on the readings during zeroing. 16.8 Changing Settings for All CO2 Modules 16.8.1 16.8.2 Changing CO2 Alarm Settings To change the CO2 alarm settings, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set alarm properties as desired. 4. Setting the CO2 Waveform To set the CO2 waveform, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set Waveform Type, Speed and Scale or CO2 Scale of the CO2 waveform. 16.8.3 Setting the RR Source To set the respiration rate (RR) source, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set RR Source. 16 - 7 When you select Auto, the system automatically selects the RR source according to the priority. The priority of RR source is first CO2, and then ECG. When the current RR source does not have valid measurement, the system automatically switches the RR Source to Auto. 16.8.4 Entering the Standby Mode Set the CO2 module to one of the following modes according to the module status:
Select Measure mode when using the CO2 module for monitoring. Select Standby mode to prolong the CO2 module service life when not using the CO2 module. The default operating mode is Measure. Whennot using the CO2 module, proceed as follows to enter the Standby mode:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set Operating Mode to Standby. 16.8.5 Entering the Intubation Mode When performing intubation during general anesthesia, enter the intubation mode to reduce unnecessary alarms. To enter the intubation mode, follow this procedure:
1. 2. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select Intubation Mode. For the details of the intubation mode, see 7.13Intubation Mode. NOTE When the configured intubation period is over, the monitor automatically exits the intubation mode and gives two alert sounds. 16.8.6 Setting the Auto Standby The monitor enters standby mode automatically if no breath is detected after the configured period of time. To set the auto standby, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set Auto Standby. 16.8.7 Setting Humidity Compensation Sidestream and microstream CO2 modules are configured to compensate CO2 readings for either Body Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patients breath, or Ambient Temperature and Pressure, Dry Gas (ATPD). ATPD: PCO2(mmHg)=CO2(vol%) x Pamb/100 BTPS (sidestream): PCO2(mmHg)=CO2(vol%) x (Pamb- 47)/100 BTPS (microstream): PCO2(mmHg)=CO2(vol%) x (1- 0.03)x Pamb/100 Where, PCO2(mmHg)= partial pressure, vol%=CO2 concentration, Pamb=ambient pressure, and unit is mmHg. For the sidestream and microstream CO2 module, set the humidity compensation on or off according to the actual condition. To set the humidity compensation, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set BTPS Compensation. Switch on for BTPS. 16 - 8 Switch off for ATPD. 16.9 Changing Settings for Sidestream and Microstream CO2 Module 16.9.1 16.9.2 Setting the Auto Standby The monitor enters standby mode automatically after the configured period of time if no breath is detected since the last detected breath. To set the auto standby, follow this procedure:
Select the CO2 numeric area or waveform area to enter the CO2 menu. Select the Setup tab. Set Auto Standby. 1. 2. 3. Setting Humidity Compensation Sidestream and microstream CO2 modules are configured to compensate CO2 readings for either Body Temperature and Pressure, Saturated Gas (BTPS), to account for humidity in the patients breath, or Ambient Temperature and Pressure, Dry Gas (ATPD). ATPD: PCO2(mmHg)=CO2(vol%) x Pamb/100 BTPS (sidestream): PCO2(mmHg)=CO2(vol%) x (Pamb- 47)/100 BTPS (microstream): PCO2(mmHg)=CO2(vol%) x (1- 0.03)x Pamb/100 Where, PCO2(mmHg)= partial pressure, vol%=CO2 concentration, Pamb=ambient pressure, and unit is mmHg. For the sidestream and microstream CO2 module, you can set the humidity compensation on or off according to the actual condition. To set the humidity compensation, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 menu. Select the Setup tab. Set BTPS Compensation. Switch on for BTPS. Switch off for ATPD. 16.9.3 Setting Flow Rate (For Sidestream CO2 Module Without O2) When you are using the sidestream CO2 module without the O2 monitoring function to monitor a neonatal patient, you can select flow rate. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab Other tab. Set CO2 Flow Rate For Neo. 16.10 Changing O2 Settings (For Sidestream CO2 Module Integrating O2) 16.10.1 Changing O2 Alarm Settings To change the O2 alarm settings, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set alarm properties as desired. 4. 16 - 9 16.10.2 Setting the O2 Waveform To set the O2 waveform, follow this procedure:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set Speed and O2 Scale of the O2 waveform. 16.11 Setting the Gas Compensation The presence of interfering gas affects the CO2 measurement. To get the best possible measurement result, it is recommended to set the gas compensation. The configured concentration of the interfering gas should be in accordance with its actual proportion. For the microstream CO2 module, gas compensations are not required. CAUTION Make sure to use the appropriate compensations. Inappropriate compensations may cause inaccurate measurement values and result in misdiagnosis. For the sidestream CO2 module, follow this procedure to set the gas compensation:
1. 2. 3. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set the compensation according to the actual condition. 16.12 Choosing a Time Interval for Peak-Picking For microstream CO2 modules, select a time interval for picking the highest CO2 as the EtCO2 and the lowest as the FiCO2. To set the time interval, follow this procedure:
1. 2. 3. 4. Select the CO2 numeric area or waveform area to enter the CO2 dialog. Select the Setup tab. Set Maximum Hold. Toggle between Single Breath, 10 s, 20 s and 30 s. Single Breath: EtCO2 and FiCO2 are calculated for every breath. 10 s, 20 s, or 30 s: EtCO2 and FiCO2 are calculated using 10, 20, or 30 seconds of data. 16.13 Performing the Leakage Test When measuring CO2 using the internal CO2 module or the sidestream CO2 module. The leakage test is required every time before the CO2 measurement. To perform the CO2 leakage test, follow this procedure:
1. Connect the measuring accessories as per section 16.6.1Preparing to Measure CO2 Using the Sidestream CO2 Module. 2. Wait until the startup finishes. Completely block the gas inlet on the sidestream CO2 module or on the N1. The alarm message CO2 Airway Occluded will appear on the screen. Continue to block the gas inlet for another one minute. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab CO2 tab. Check that the current flow rate is less than 10ml/min, and the alarm message CO2 Airway Occluded does not disappear. 3. 4. 5. 6. 16 - 10 This indicates that the module does not leak. If the alarm message disappears, or the flow rate is equal to 10ml/min or greater, it indicates that the module leaks. Perform the leakage test again. If the problem remains, contact your service personnel for help. 16.14 CO2 Calibration For sidestream and microstream CO2 modules, a calibration is needed every year or when the measured values have a great deviation. To calibrate the CO2 module, contact your service personnel. CAUTION Connect the gas outlet to the scavenging system when calibrating the CO2 module. 16.15 CO2 Troubleshooting This section lists the problems that might occur. If you encounter the problems when using the equipment or accessories, check the table below before requesting service. If the problem persists, contact your service personnel. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. 16.15.1 Troubleshooting the Sidestream/Microstream CO2 Module Problem Solution EtCO2 measurements too low 1. Check the patient status. 2. Check the sample line and connectors for leakage. 3. Ventilate the room if the environmental CO2 concentration is too high. 16.15.2 Troubleshooting the Mainstream CO2 Module Problem Elevated baseline Solution 1. Check the patient status. 2. Check the sensor. 16.16 Oridion Information Oridion Patents This posting serves as notice under 35 U.S.C.287(a) for Covidien patents: http://www.covidien.com/patents. No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO2 sampling consumables which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device and/or CO2 sampling consumable. 16 - 11 17 Monitoring Anesthetic Gas (AG) 17.1 AG Introduction The anesthetic gas (AG) module measures the patients anesthetic and respiratory gases by connecting to the airway of intubated patients or collecting the gases with specified accessories. It also incorporates the features of the O2 module. The AG module determines the concentration of certain gases using the infrared (IR) light absorption measurement. The gases that can be measured by the AG module absorbing IR light. Each gas has its own absorption characteristic. The gas is transported into a sample cell, and an optical IR filter selects a specific band of IR light to pass through the gas. For multiple gas measurements, there are multiple IR filters. The higher the concentration of gas in a given volume, the more IR light is absorbed. This means that higher concentration of IR absorbing gas causes a lower transmission of IR light. The amount of IR light transmitted after it has been passed through an IR absorbing gas is measured. From the amount of IR light measured, the concentration of gas present can be calculated. Oxygen does not absorb IR light as other breathing gases and is therefore measured relying on its paramagnetic properties. Inside the O2 sensor are two nitrogen-filled glass spheres mounted on a strong rare metal taut-band suspension. This assembly is suspended in a symmetrical non-uniform magnetic field. In the presence of paramagnetic oxygen, the glass spheres are pushed further away from the strongest part of the magnetic field. The strength of the torque acting on the suspension is proportional to the oxygen concentration. From the strength of the torque, the concentration of oxygen is calculated. AG monitoring is intended for adult, pediatric and neonatal patients. You can monitor AG using the external AG module. The following picture shows the external AG module.
(1)
(2)
(3)
(4)
(1) AG dialog hard key
(2) Gas outlet
(3) AG Measure/standby hard key
(4) Watertrap seat NOTE The AG module is configured with automatic barometric pressure compensation function. 17 - 1 17.2 AG Safety Information WARNING To avoid explosion hazard, do not use flammable anesthetic agent such as ether and cyclopropane for this equipment. Using high-frequency electrosurgical units may increase the risk of skin burn. In this case, do not use Route all tubing away from the patients throat to avoid strangulation. antistatic or conductive respiratory tubing. CAUTION Perform the measurement in a well-ventilated environment. EtCO2 values measured from the AG module may differ from that of from the blood gas analysis. NOTE The AG module automatically suppresses physiological alarms until breathing waves have been detected. Make sure that a patient is properly connected when monitoring with the AG module. 17.3 AG Measurement Limitations The following factors may influence the measurement accuracy:
Leaks or internal venting of sampled gas Mechanical shock Cyclic pressure up to 10 kPa (100 cmH2O) Other sources of interference, if any 17.4 AG Display The AG module can send waves and numerics for all measured anesthetic gases for display on the monitor, including:
CO2, O2, N2O and AA waves awRR: airway respiratory rate MAC: minimum alveolar concentration End tidal (Et) and fraction of inspired (Fi) numerics for CO2, O2, N2O and AA AA represents one of the following agents: Des (desflurane), Iso (isoflurane), Enf (enflurane), Sev (sevoflurane), or Hal (halothane). 17 - 2 If only one anesthetic agent is used, the AA waveform area displays the waveform of this anesthetic agent. If several anesthetic agents are used, the AA waveform area displays the waveform of the primary anesthetic agent. 17.5 AG Equipment to Patient Connection
(4)
(5)
()
(1) AG module
(3) Watertrap
(2) Gas outlet
(4) Gas sample line
(5) Airway adapter (connected to patient)
(6) Y-piece (connected to the anesthesia machine) 17.6 Preparing for AG Monitoring To prepare to monitor AG, follow this procedure:
1. 2. 3. 4. 5. Select the appropriate gas sample line and watertrap according to the patient category. Connect the watertrap to the AG module, and connect the gas sample line to the watertrap. Connect the other end of the gas sample line to the patient via the airway adapter. Connect the gas outlet to a scavenging system or the patient respiration circuit using an exhaust tube. Check that the connections are tight. After the AG module is connected to the SMR, the AG module enters the measurement mode by default and the monitor prompts AG Starting. AG measurement is available after the start-up is completed. When using the AG module, connect the gas outlet to the scavenging system or the patient respiration circuit when in use with the Mindray A7 anesthesia machine. WARNING Make sure that the connections are tight. Any leak in the system can result in erroneous readings Always inspect the airway adapter for a tight connection and proper operation before attaching it to the patient. Squeezing or bending the gas sample line during AG measurement may cause erroneous readings or no readings. due to ambient air mixing with patient gases. CAUTION Position the airway adapter so that the part connecting to the gas sample line is pointing upwards. This prevents condensed water from passing into the gas sample line and causing an occlusion. 17 - 3 The watertrap collects water drops condensed in the sample line and therefore prevents them from entering the module. To avoid blocking the airway, empty the watertrap container whenever half full. The watertrap has a filter preventing bacterium, water and secretions from entering the module. After long-term use, dust or other substances may compromise the performance of the filter or even block the airway. In this case, replace the watertrap. Replacing the watertrap once a month is recommended. NOTE Do not apply adult watertrap to the neonatal patient. Otherwise, patient injury could result. To extend the lifetime of the watertrap and module, disconnect the watertrap from the module and set the operating mode to Standby when AG monitoring is not required. 17.7 MAC Values Minimum alveolar concentration (MAC) is the minimum concentration of the agent in the alveoli. It is a basic index to indicate the depth of anesthesia. The standard ISO 80601-2-55 defines MAC as this: alveolar concentration of an inhaled anesthetic agent that, in the absence of other anesthetic agents and at equilibrium, prevents 50% of patients from moving in response to a standard surgical stimulus. MAC values are listed below:
Agent 1 MAC Des 6%
Iso 1.15%
Enf 1.7%
Sev 2.1%
Hal 0.77%
N2O 105%*
* indicates 1 MAC nitrous oxide can only be reached in hyperbaric chamber. NOTE The formula to calculate the MAC value is as follows:
The MAC values shown in the table above are those published by the U.S. Food and Drug Administration for a healthy 40-year-old adult male patient. In actual applications, the MAC value may be affected by age, weight and other factors. MAC N 1
=
i 0=
EtAgent
-------------------------------------
AgentVolagei Where N is the number of all agents (including N2O) that the AG module can measure, EtAgenti is the concentration of each agent, and AgentVolagei is the concentration of each agent at 1 MAC with age correction. The formula for calculating age correction of 1 MAC is:
) MACage MAC40 10 0.00269 age 40
=
(
(
)
(
For example, the Des concentration at 1 MAC of a 60-year old patient is.
) 6% 10 0.00269 60 40 The AG module measures 4% of Des, 0.5% of Hal and 50% of N2O in the patients end-tidal gas:
6% 0.88
=
(
) MAC
=
4.0%
6% 0.88------------------------
+
0.5%
---------------------------------
+
0.77% 0.88 50%
105% 0.88------------------------------
=
2.04 NOTE The formula above is only suitable for patients who are older than one year. If the patient is less than one year, the system uses one year old to do age correction. 17 - 4 17.8 Changing AG Settings 17.8.1 Changing AG Alarm Settings To change the AG alarm settings, follow this procedure:
1. 2. 3. 4. 5. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired gas tab. Select the Alarm tab. Enter the password if required. For more information, refer to 25.13.3Selecting Password for User Authentication. Set alarm properties as desired. 17.8.2 Setting the O2 Compensation If the AG module does not incorporate the O2 module, you need to set the amount of O2 in the ventilation gas mixture. To set the O2 compensation, follow this procedure:
1. 2. 3. Select the AG numeric area or waveform area to enter the Gas dialog. Select the Setup tab. Set O2 Compensation:
Select Off when the amount of O2 is less than 30%. Select the other options in accordance with the O2 concentration in the gas mixture. If the AG module incorporates the O2 module, the system directly uses the O2 concentration detected by the O2 module to make compensation. In this case, O2 Compensation is fixed to Off. 17.8.3 Entering the Standby Mode Set the AG module to one of the following modes according to the module status:
Select Measure mode when using the AG module for monitoring. Select Standby mode when not using the AG module. The default operating mode is Measure. If not using the AG module, follow this procedure to enter the Standby mode:
1. 2. 3. 4. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired gas tab. Select the Setup tab. Set Operating Mode to Standby. 17.8.4 Setting Auto Standby The monitor enters the standby mode automatically after the configured period of time if no breath is detected since the last detected breath. To set the auto standby, follow this procedure:
1. 2. 3. 4. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired gas tab. Select the Setup tab. Set Auto Standby. 17.8.5 Setting the Gas Waveform To set the gas waveform, follow this procedure:
1. 2. 3. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired gas tab. Select the Setup tab. 17 - 5 4. Set the speed and scale of gas waveforms. For CO2, set Waveform Type. 17.8.6 Setting the RR Source To set the RR (respiration rate) source, follow this procedure:
1. 2. 3. 4. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired gas tab. Select the Setup tab. Set RR Source. When the current RR source does not have valid measurement, the system will automatically switch RR Source to Auto. 17.8.7 Entering the Intubation Mode When performing intubation during general anesthesia, enter the intubation mode to reduce unnecessary alarms. To enter the intubation mode, follow this procedure:
1. 2. Select the AG numeric area or waveform area to enter the Gas dialog. Select Intubation Mode from the bottom of the dialog. For the details of the intubation mode, see 7.13Intubation Mode. 17.8.8 Enabling or Disabling MAC Display Set whether MAC value is displayed in the AG numeric area by following this procedure:
1. 2. 3. Select the AG numeric area or waveform area to enter the Gas dialog. Select the desired anesthetic agent tab. Switch on or off MAC. 17.9 Changing the Anesthetic Agent When the anesthetic agent used on the patient is changed, the AG module detects the mixed anesthetic gas during the transition of two anesthetic agents. The time required for completing the replacement of anesthetic agent depends on anesthesia type (low flow or high flow) and the characteristics of anesthetic agents
(pharmacokinetics). During the transition of two anesthetic agents, the monitor gives no prompt messages and the MAC value displayed may be inaccurate. The AG module can identify two anesthetic agents automatically. When the proportion of primary and secondary anesthetic agents in the mixture changes, the AG module can distinguish between them according to their contributions to the MAC value. Then primary and secondary anesthetic agents will be exchanged for display. 17.10 Performing AG Leakage Test The AG leakage test is required every time before the AG measurement. To perform the AG leakage test, follow this procedure:
Plug the AG module into the module rack. 1. 2. Wait for about one minute until the AG module warms up. Completely block the gas inlet of the AG module. Then the alarm message AG Airway Occluded will appear on the screen. Block the gas inlet for another one minute. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab AG tab. Check that the current flow rate is less than 10 ml/min, and the alarm message AG Airway Occluded does not disappear. 3. 4. 5. 6. 17 - 6 This indicates that the module does not leak. If the alarm message disappears, or the flow rate is equal to 10ml/min or greater, it indicates that the module leaks. Perform the leakage test again. If the problem remains, contact your service personnel for help. 17.11 Calibrating the AG Module Calibrate the AG module every year or when the measured value is outside the specification. To calibrate the AG module, contact the service personnel. CAUTION Connect the gas outlet to the scavenging system when calibrating the AG module. 17.12 AG Troubleshooting If the AG airway is occluded, the message AG Airway Occluded appears. In this case, check for the follows until the message disappears:
1. 2. 3. 4. Check the airway adapter for occlusion and replace if necessary. Check the sample line for occlusion or kinking and replace if necessary. Check the watertrap for water or occlusion. Empty the watertrap, or replace the watertrap if necessary. Check the gas outlet and the exhaust tube for any occlusion. If the message does not disappear, it is probably the module fault. Contact the service personnel in this case. NOTE For the physiological and technical alarm messages, see Appendix DAlarm Messages. 17 - 7 18 Review 18.1 Review Overview Trends are patient data collected over time and displayed in graphic, tabular, or other forms to give you a picture of how the patient's condition is developing. You can review the trend data in the Review dialog, minitrends screen, or OxyCRG screen. The Review dialog also enables access to review the events, 12-lead ECG analysis results and waveforms, full disclosure waveforms, and so on. 18.2 Review Dialog The Review dialog contains tabs to display trend data in tabular, graphic, or other forms. 18.2.1 Accessing the Review Dialog Choose one of the following methods to enter the review dialog:
Select the Review quick key. Select the Main Menu quick key from the Review column select the desired option. 18.2.2 Example Review Dialog The review pages have a common structure. The graphic trends review page is taken as an example:
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(1) Event type indicator: different color blocks match different types of events:
Red: high priority alarm event Yellow: medium priority alarm event Cyan: low priority alarm event Green: manual event White: operation-related event
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(3) Current screen time line: indicates the time length of the current screen. Waveform area: displays trend curves. The color of trend curves is consistent with the color of parameter labels. 18 - 1
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(8) Time line: indicates the entire time length.
: indicates the time length of trend data. can be moved within this time length.
: indicates the time length of no trend data. cannot be moved within this time length. Different color blocks along the time line indicate events of different types. See the color definition for the event type indicator. Event area: displays the event of the cursor time. Selecting the event access the event list. If there is no event at the cursor time, the cursor time is displayed. Cursor: this is adjusted by touching different locations. Adjusting this can adjust the Event area and Numeric area. Numeric area: displays numeric values at the cursor indicated time. The background color of numeric values matches the alarm priority. Slider: indicates the position of current screen time in the entire time length. Dragging this button left or right enables you to locate the trend data at a specific time and also refreshes trend data in current screen accordingly.
(9) Button area. 18.2.3 Symbols on Review Pages The following table lists the symbols on review pages. Symbol Description Slider: indicates the position of current screen time in the entire time length. Dragging the slider left or right enables you to locate the trend data at a specific time and also refreshes data in current screen accordingly. or Goes to the previous or next event.
+
Event list: displays events in a chronological order. The most recent event is displayed at the top.The number of asterisk symbols before an event indicates alarm priority. Record button: select it to output patient information and data through the recorder. Print button: select it to output patient information and data through the printer. Indicates that the followed parameter is from an external device connected to the monitor via the BeneLink module. 18.2.4 Common Operations This section describes common operations for all review pages. 18.2.4.1 Browsing Trend Data Browse trend data in one of the following ways:
Move the cursor. Move the slider Slide your finger on the screen. 18.2.4.2 Viewing Events You can view the following types of events:
Manually triggered events Parameter-related operation events and alarm-related events, such as starting C.O. measurement Operation events not related to parameters, such as system time change View events in either of the following ways:
Select Select and select the desired event. or to jump to the previous event or next event. 18 - 2 Events are displayed in a chronological order. The most recent event is displayed at the top. The number of asterisk symbols before an event indicates alarm priority as follows:
***: high priority alarm
**: medium priority alarm
*: low priority alarm 18.2.5 Tabular Trends Review Page The tabular trends review page displays trend data in a tabular form. 18.2.5.1 Entering the Tabular Trends Review Page Choose one of the following methods to enter the tabular trends review page:
Select the Review quick key select the Tabular Trends tab. Select the Main Menu quick key from the Review column select Tabular Trends. 18.2.5.2 Changing the Tabular Trend Group To change the tabular trend group, follow this procedure:
1. 2. Enter the tabular trends review page. Set Trend Group. 18.2.5.3 Editing the Tabular Trend Group The setting of the Trend Group defines the contents of displayed printed trends. It is possible to edit any trend group except for the All and Standard trend groups. To do so, follow this procedure:
1. 2. Enter the tabular trends review page:
Select Group Setup select the desired tab. Rename the trend group (optional): select the desired name. symbol at the upper left corner and input the Add parameters: select desired parameters from the Choices column, and then select Add. Selecting Add All adds all parameters (up to the maximum of 83). Delete parameters: select desired parameters from the Selected column, and then select Delete. Selecting Delete All deletes all parameters except for HR. Move the position of parameters displayed on the trend page: select desired parameters from the Selected column, and then select Move up, Move Down, Move to Top, or Move to Bottom. Display two parameters side by side: select two parameters from the Selected column, and then select Overlap. Then, the symbol appears at the right of the overlapped parameters. The overlapped parameters will be displayed side by side in one numerics area and waveform area. Unoverlap two parameters: select the overlapped parameters from the Selected column, and then select Unoverlap. Selecting Default will restore the trend group settings to factory defaults. NOTE Trend groups labeled All or Standard cannot be edited. The HR parameter and waveform are always displayed in the first row on the trend page. It cannot be deleted or moved. 18.2.5.4 Changing the Resolution of Tabular Trend Data The interval of tabular trends defines the interval of displaying trend data. A short interval is especially suited for neonatal applications, where the clinical situation may change very quickly. In adult monitoring, where the patient's status typically changes more gradually, a longer interval may be more informative. To change the interval of trend data, follow this procedure:
18 - 3 1. 2. Enter the tabular trends review page. Select Interval. 5 sec or 30 sec: select to view up to 4 hours of tabular trends at an interval of 5 seconds or 30 seconds. 1 min, 5 min, 10 min, 15 min, 30 min, 1 hr, 2 hrs, or 3 hrs: select to view up to 120 hours of tabular trends at selected interval. Select parameters, such as NIBP, or C.O., to view the tabular trends when these parameter measurements are acquired. NOTE Changing between intervals does not typically change the position of the slider or cursor except to round it to the nearest interval, however changing intervals to be 30 seconds or less will move any cursor position more than 4 hours ago to the oldest data less than 4 hours ago. 18.2.5.5 Printing a Tabular Trends Report To print a tabular trends report, follow this procedure:
1. 2. 3. 4. to enter the Print Setup dialog. Enter the tabular trends review page. Select Set the tabular trends report as described in 22.6.4Configuring Graphic Trends Reports. Select Print or Print (All). Print: the trend data before the above set Time, for the above set Period, and at the above set Interval will be printed. Print (All): all the stored trend data will be printed at the review interval.. 18.2.5.6 Recording Tabular Trends To print tabular trends with the recorder, follow this procedure:
1. 2. 3. 4. to enter the Record Setup dialog. Enter the tabular trends review page. Select Respectively set Start Time and End Time of the tabular trends data. Select Record or Record (All). Record: the trend data between the Start Time and End Time will be recorded. Record (All): all the stored trend data at the review interval will be recorded. 18.2.6 Graphics Trends Review Page The graphic trends review page displays trend data in a visual format. 18.2.6.1 Entering the Graphic Trends Review Page Choose one of the following methods to enter the graphic trends review page:
Select the Review quick key select the Graphic Trends tab. Select the Main Menu quick key from the Review column select Graphic Trends. 18.2.6.2 Changing the Graphic Trend Group To change the graphic trend group, follow this procedure:
1. 2. Enter the graphic trends review page. Set Trend Group. 18 - 4 18.2.6.3 Editing the Graphic Trend Group 1. 2. Enter the graphic trends review page. Select Group Setup. For more information, see 18.2.5.3Editing the Tabular Trend Group for detail on how to edit the group. 18.2.6.4 Changing the Resolution of Trend Data To change the length of trend data displayed on the current screen, follow this procedure:
1. 2. Enter the graphic trends review page. Select Zoom. 8 min: the screen displays eight minutes of trend data. You can view the most recent one hour of data. 30 min, 1 hr, 2 hrs, 4 hrs: the screen displays 30 minutes, one hour, two hours, or four hours of trend data. You can view the most recent four hours of data. 8 hrs, 12 hrs, 24 hrs, 48 hrs: the screen displays 8 hours, 12 hours, 24 hours, or 48 hours of trend data. You can view the most recent 120 hours of data. 18.2.6.5 Changing the Number of Waveforms To change the number of waveforms displayed on the trend review page, follow this procedure:
1. 2. Enter the graphic trends review page. Select Trends. 18.2.6.6 Printing a Graphic Trends Report To print a graphic trends report, follow this procedure:
1. 2. 3. 4. to enter the Print Setup dialog. Enter the graphic trends review page. Select Set the graphic trends report as described in 22.6.4Configuring Graphic Trends Reports. Select Print to print the graphic trend data before the above set Time and for the above set Period. 18.2.7 Events Review Page The monitor stores events in real time, including technical alarm events, physiological alarm events, manual events, and operational events. When an event occurs, all the measurement numerics and three event-related waveforms 16 seconds before and after the event are stored. NOTE Alarms are saved as events and will be maintained if the equipment is powered down. The time of A total loss of power does not affect the events already stored. equipment power down is not recorded as an event and cannot be reviewed. Earlier events will be overwritten by later ones if the storage capacity is reached. 18.2.7.1 Entering the Events Review Page Choose one of the following methods to enter the events review page:
Select the Review quick key select the Events tab. Select the Main Menu quick key from the Review column select Events. The Event page displays the event list. Events are displayed in descending chronological order, with the most recent displayed at the top. The number of asterisk symbols before an event indicate alarm priority as described in 7.3.3Alarm Indicators. Different color blocks are displayed on the left of each event to indicate different event types. 18 - 5 Red: high priority alarm event Yellow: medium priority alarm event Cyan: low priority alarm event Green: manual event White: operation-related event, such as accepting a C.O. average. The number of currently selected events and the total number of events are displayed at the top right corner of the event list. For example, 2/4 indicates that the selected event is the second event in the filtered events and the total number of filtered events is 4. Total indicates the total number of events. For example: Total: 28 means that there are a total of 28 events. 18.2.7.2 Configuring the Filter You can filter events by time, alarm priority, alarm category, or parameter group. To configure the filter, follow this procedure:
1. Enter the Events page. Select Filter Setup and set the desired filter criterion. Closing the Filter Setup dialog will automatically turn on the Filter, as can be seen in the Event's tab. Events allowed by the filter will be displayed in the event list. 18.2.7.3 Editing Events To edit events, follow this procedure:
1. 2. to edit the selected events. Enter the Events page and tick off the desired events. Select Lock: manually lock the event. Locked events cannot be deleted. Note: enter comments for the event. Rename: allow renaming an event name. Only manual events and arrhythmia events can be renamed if enabled by the hospitals settings. 18.2.7.4 Viewing Event Details To view waveforms and parameter values at the event time, follow this procedure:
1. 2. Enter the Events page. Select Detail. To display beat labels on the first ECG waveform, switch on Beat Anno. The white beat labels indicate heart beats classification and may explain suspected, missed, or false arrhythmia calls. Heart beats are classified as follows:
N = Normal V = Ventricular ectopic S = Supraventricular premature P = Paced L = Learning
? = Insufficient information to classify beat I = Inoperative (for example, Lead Off) M = Missed beat If you switch on Beat Anno on the Events page, beat labels will also be displayed on the Full Disclosure page, and vise versa. Beat labels can be printed out. 18.2.7.5 Printing Event Reports To print event reports via a printer, follow this procedure:
1. 2. Enter the events review page. Select to enter the Print Setup dialog. 18 - 6 3. 4. Select the desired options. Print All Event List: print the entire event list. Print List of Selected Events: print the list of selected events. Print Detail of Selected Events: print the details of selected events. Print Displayed Event Detail: print the waveforms and parameters of the currently displayed event. Select Print. 18.2.7.6 Recording Event Details To print events details via a recorder, follow this procedure:
1. 2. 3. Enter the events review page. Select the Detail button. Select to print the details of the event. 18.2.8 Full Disclosure Review Page You can review up to 48-hours of waveform data on the full disclosure review page. You can view both the compressed waveforms, full waveforms and numeric values. 18.2.8.1 18.2.8.2 Entering the Full Disclosure Review Page Choose one of the following methods to enter the full disclosure review page:
Select the Review quick key select the Full Disclosure tab. Select the Main Menu quick key from the Review column select Full Disclosure. Selecting Waveforms You can select the waveforms to be displayed and stored. Up to 48 hours of waveforms for all parameters can be stored. When closing the Select Waveform dialog, a prompt will inform you of the duration of waveforms that can be saved if the amount is less than 48 hours. To save and display the desired waveforms, follow this procedure:
1. 2. 3. Enter the full disclosure review page. Select Setup to enter the Select Waveform page. Select the Storage tab and set the desired waveforms to be stored in the monitor. Select the Display
(Maximum: 3) tab and set the desired waveforms to be displayed on the Full Disclosure page. NOTE Storing more waveforms may shorten the storage time to less than 48 hours. Please adjust the waveforms stored with this consideration. In case of alarms, the background of the compressed waveform is highlighted with a colored block during the alarm time:
Red: high alarm priority Yellow: medium alarm priority Cyan: low alarm priority 18.2.8.3 Setting Scale and Duration To set the length and size of displayed compressed waveforms, follow this procedure:
1. 2. Enter the full disclosure review page. Set the waveforms scale in either of the following ways:
Select the Scale button. If you do not see Scale, then select the Select waveform label. button to show it. 18 - 7 3. 4. Select Duration to set the length of displayed waveforms. Select the parameter label beside the waveforms to set scale for each parameter. 18.2.8.4 Viewing Details of Compressed Waveforms To view the full waveforms and numeric values, follow this procedure:
1. 2. Enter the full disclosure review page. Select Detail. You can perform the following operations on the this page:
Switch on Beat Anno. For more information, see 18.2.7.4Viewing Event Details. Select Speed, ECG Gain, or Save As Event. If you do not see an option, then select the button to show it. Select Overview to switch to the compressed waveform view. 18.2.8.5 Printing the Full Disclosure Waveform Report To print a compressed waveform report, follow this procedure:
1. 2. 3. Enter the full disclosure review page. Select to enter the Print Setup dialog. Select waveform type you want to print:
Print Waveform Overview: compressed waveform of selected period will be printed. This option is only available when printing from the Overview or compressed waveform view. Print Displayed Waveform Detail: parameter values and all stored waveforms around the cursor time will be printed. This option is only available when printing from the Detail view. 4. Select Print. 18.2.8.6 Recording the Details of the Compressed Waveform To record a Full Disclosure Detail Record Report, follow this procedure:
1. 2. 3. Enter the Full Disclosure page. Select Detail. Select
. 18.2.9 Arrhy Statistics Review Page The Arrhy Statistics review page shows arrhythmia events happened over the lastest 24 hours. This page is only available with the ECG 24h Summary option. To enter the Arrhy Statistics review page, choose one of the following methods:
Select the Review quick key select the Arrhy Statistics tab. Select the Main Menu quick key from the Review column select Arrhy Statistics. Selecting each type of arrhythmia statistics bar shows compressed waveforms, the time and duration of each arrhythmia event. Selecting the compression waveform shows the event details. 18.2.10 OxyCRG Review Page You can review up to 48 hours of trend curves on the OxyCRG review page. The OxyCRG review functionality is available for neonatal monitoring only. NOTE OxyCRG Review Page is available only when Patient Category is set to Neo. 18 - 8 18.2.10.1 Entering the OxyCRG Review Page Choose one of the following methods to enter the OxyCRG review page:
From the OxyCRG screen, select the ABD events list area. Select the Review quick key select the OxyCRG tab. Select the Main Menu quick key from the Review column select OxyCRG. 18.2.10.2 The Display of the OxyCRG Review Page The following figure shows the OxyCRG screen:
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(4) Event title area: displays information of the selected event, such as the event type and time. Event detail area: displays parameter trends, compressed waveform, and parameter values of selected event. Event summary area: displays ABD events within the Zoom period. The selected event is enclosed in a white frame. Event statistics area: displays the total number of ABD events and the numbers of each event within the Zoom period. 18.2.10.3 Changing the Resolution of Trend Curves To set the resolution of trend curves, follow this procedure:
1. 2. Enter the OxyCRG review page. Set Zoom. NOTE If the Zoom is set for a large duration (for example, 8 hrs), the screen may show "No Patient Data" for the first several minutes of data collection (for example, 6 minutes), but data will be shown after enough data has been collected. 18.2.10.4 Printing an OxyCRG Review Report To print an OxyCRG review report, follow this procedure:
1. 2. 3. Enter the OxyCRG review page. Select to enter the Print Setup dialog. Select Print. The report duration corresponds to the duration of data shown on the screen. 18 - 9 18.2.11 12-Lead ECG Review Page When 12-lead ECG analysis is performed, you can review the most recent 20 events of 12-lead analysis. For more information, see 9Resting 12-Lead ECG Analysis. 18.2.11.1 Entering the 12-Lead Review Page Choose one of the following methods to enter the 12-lead ECG review page:
Upon completion of 12-lead ECG analysis, select Review from the 12-Lead Interpretation page. For more information, see 9Resting 12-Lead ECG Analysis. Select the Review quick key select 12-Lead ECG. Select the Main Menu quick key from the Review column select 12-Lead ECG. 18.2.11.2 Switching to Median Complex (for Glasgow Algorithm Only) The median complex template displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and one rhythm lead waveform at the bottom. Additionally, a short vertical bar appears above each waveform, marking the start and end position of the P-wave and the QRS-wave and the end position of T-wave. To view Median Complex, follow this procedure:
1. 2. Enter the 12-lead review page. Select Median Complex. Selecting Waveform can return to the 12-lead ECG waveform page. 18.2.11.3 Setting 12-Lead ECG Waveforms To set the 12-lead ECG waveforms on the review page, follow this procedure:
1. 2. Enter the 12-lead review page. Set Speed, Gain, and Layout. 18.2.11.4 Printing the 12-Lead ECG Report To print the 12-Lead ECG report, follow this procedure:
1. 2. 3. 4. Enter the 12-lead review page. Select
. Configure the 12-lead ECG report. Select Print. 18.2.11.5 Recording the 12-Lead ECG Report To print the 12-Lead ECG report via the recorder, follow this procedure:
1. 2. Enter the 12-lead review page. Select
. 18.2.12 ST Review Page When ST analysis is enabled, the monitor saves ST segments and values at an interval of one minute. You can review the latest 120 hours of ST data. 18.2.12.1 Entering the ST Review Page Choose either of the following methods to enter the ST review page:
Select the Review quick key select the ST tab. Select the Main Menu quick key from the Review column select ST. 18 - 10 18.2.12.2 Setting the ST Reference You can set the currently displayed ST as reference. To do so, follow this procedure:
1. 2. Enter the ST review page. Select Set Reference. NOTE The ST baseline is used as ST reference by default. 18.2.12.3 Displaying/Hiding the ST Reference To display or hide ST reference, follow this procedure:
1. 2. Enter the ST review page. Select Display Reference or Hide Reference. 18.2.12.4 Displaying/Hiding Markers To display or hide markers, follow this procedure:
1. 2. Enter the ST review page. Select Display Marker or Hide Marker. 18.2.12.5 Printing ST Data To print ST data, follow this procedure:
1. 2. Enter the ST review page. Select
. 18.3 18.3.1 18.3.2 Reviewing Discharged Patients For discharged patients, you can review the trend data in the review page. You can also review the events and 12-lead ECG analysis results. Checking the Data of a Discharged Patient 1. Access the Discharged Patients dialog box by either of the following ways:
Select the Discharged Patients quick key. Select the Main Menu quick key from the Patient Management column select Discharged Patients. 2. 3. From the patient list select the desired patient. Select Detail. Checking the Information of a Discharged Patient 1. 2. 3. Access the data of the discharged patient as described in 18.3.1Checking the Data of a Discharged Patient. Select the Select OK to exit the Patient Management dialog box. icon to enter the Patient Management dialog box. 18 - 11 19 Clinical Assistive Applications (CAA) The Clinical Assistive Applications (CAA) function integrates some commonly used clinical guidelines and tools into the monitor. It puts the currently monitoring parameter measurements together and provides comprehensive analysis results. CAA can improve the clinicians working efficiency. However, it is not directly used for diagnosis and cannot not replace the clinicians judgement. 19.1 Early Warning Score (EWS) The Early Warning Scores (EWS) can help you recognize the early sign of deterioration in patients based on vital signs and clinical observations. Depending on the score calculated, appropriate recommendations are displayed. The monitor supports the following scores:
MEWS (Modified Early Warning Score) NEWS (National Early Warning Score) NEWS2 (National Early Warning Score 2) Custom Score A subscore is given for each parameter based on the measured or entered value. When all the required parameters are entered or measured, the subscores are added together to calculate the total early warning score. Each subscore has a color coding to indicate associated level of risk, When the total score is outside of the thresholds, actions are recommended. MEWS, NEWS and NEWS2 can give total scores. Custom Score is based on user-defined parameters. MEWS, NEWS and NEWS2 are intended for adult patients only. The patient category applied to the Custom Score is defined by Mindray Clinical Score Configuration Tool. For more information, see Mindray Clinical Scoring Config Tool Instruction for Use (P/N: 046-012986-00). WARNING The EWS scores and recommended actions are for reference only and cannot be directly used for diagnostic interpretation. EWS cannot be used as an prognosis index. It is not a clinical judgement tool. Clinicians must use their clinical judgement in conjunction with the EWS tool at all times. MEWS and NEWS are intended for adult patients only. NEWS is not applicable to pregnant woman and COPD (Chronic Obstructive Pulmonary Disease) patients. NOTE The EWS scores does not trigger any alarms and cannot used for continuous monitoring. 19 - 1 19.1.1 Displaying the EWS Numerics Area To display the EWS numerics area, follow this procedure:
1. 2. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select the Main Menu quick key from the Display column select Tile Layout. Select the parameter area where you want to display the EWS score, and then from the popup list select EWS.
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(4) EWS protocol label
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(5) Total score. The color of the circle indicates the level of risk. For IPS, no score is displayed. Only level of risk is shown: white means normal and red indicates alert. Single parameter whose score reaches 3 Latest history total score Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white square frame. For IPS, this indicator does not display. Scoring interval The current scoring time Scoring countdown: time to the next scoring.
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(8) 19.1.2 Accessing the EWS Screen Access the EWS window in any of the following ways:
Select the EWS parameter area Select the EWS quick key. Select the Screen Setup quick key select the Choose Screen tab select EWS. Select the Main Menu quick key from the CAA column select EWS. Take NEWS2 as an example, the EWS screen is shown as follows. Your screen may be slightly different due to the configuration. 19 - 2
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(9) Total score. The color of the circle indicates the level of risk. Risk level indicator. The level of risk increases from top down. The current level is enclosed by a white frame. Parameter area: display the subscore and parameter value of each parameter. The keyboard symbol indicates that the parameter value is manually entered. History total scores Operator ID (displays only when the operator ID is selected) Selecting this button to see the clinical response to the current score Scoring interval EWS protocol label Scoring countdown: time to the next scoring.
(10) The scoring time 19.1.3 Performing EWS Scoring To perform scoring, follow this procedure:
1. 2. Select Reset to clear the previous score and update values of currently monitored parameters and relevant subscores. For NEWS2, set the SpO2 Scale. Scale 1: for patient without hypercapnic respiratory failure. Scale 2: for patients with a prescribed oxygen saturation requirement of 8892% (for example, in patients with hypercapnic respiratory failure). 3. Measure or manually enter other required parameters and observations. 4. 5. 6. If enabled, select the operator ID Select Calculate to get the total score. If Score Confirmation is enabled, select Confirm to save current scoring, or select Cancel to give up current scoring. Refer to section 19.1.4.2Setting the Scoring Confirmation Switch for more information. 19 - 3 CAUTION The decision to use Scale 2 of the SpO2 Scale should be made by a competent clinical decision maker and should be recorded in the patients clinical notes. NOTE Before calculating the score, select Reset to clear the previous score. You can get the score only when all required parameters have been measured or entered. The keyboard symbol at the right of the parameter value indicates that the value is manually entered. 19.1.4 Changing EWS Settings 19.1.4.1 Changing the Scoring Protocol The monitor is configured with a default scoring protocol. To change the scoring protocol, follow this procedure:
1. 2. From the EWS page select Setup. Set Score. 19.1.4.2 Setting the Scoring Confirmation Switch To select if confirmation is required before saving score, follow this procedure:
1. 2. From the EWS page select Setup. Set Scoring Confirmation switch. Off: the monitor automatically saves the scoring result after the scoring is completed. On: you need to confirm that whether the scoring result is saved or not after the scoring is completed. 19.1.4.3 Setting the Manual Data Timeout The manually input parameter data become invalid after a preset time. To set the timeout period for the input data, follow this procedure:
1. 2. From the EWS screen select Setup. From the Manual Data Timeout area, select a desired parameter and set its timeout period. NOTE If the data is expired and not updated, the monitor displays the corresponding parameter score in outline font, and gives a timeout alarm. 19.1.4.4 Setting Auto Scoring The monitor automatically starts scoring at the preset interval. To set auto scoring, follow this procedure:
1. 2. From the EWS page select Setup. Set Auto Scoring:
Interval: the monitor automatically starts scoring at the preset interval. NIBP: the monitor automatically starts scoring at the completion of each NIBP measurement. Alarm: the monitor automatically starts scoring when an alarm occurs to the parameter for scoring. If no option is selected, the monitor does not initiate auto scoring. 19 - 4 19.1.4.5 Setting Auto Scoring Interval 1. 2. From the EWS page select Setup. Set Interval:
By Score: the monitor automatically starts scoring as per the interval selected for corresponding total score. 5 min - 24 h: If Auto Scoring is set to Interval, the monitor automatically starts scoring as per the selected interval. If Auto Scoring is not set to Interval, the countdown timer of manual scoring is selected. 19.1.4.6 Managing Operator ID To manage the Operator ID, follow this procedure:
1. 2. From the EWS page select Setup. Select the Manage Operator ID button at the bottom left corner to add or delete the operator IDs. NOTE Manage Operator ID button is available when it is enabled in the Maintenance menu. For more information, see section 25.4.1.1Displaying and Managing the Operator ID. 19.2 Glasgow Coma Scale (GCS) The Glasgow Coma Scale (GCS) function is based on Teasdales Assessment of Coma and Impaired Consciousness-A Practical Scale (Lancet, 1974). Three aspects of behavior are independently measured: eye opening, verbal response, and motor response. The scores are added together to indicate that patients level of consciousness. GCS is intended for adults and pediatric patients. CAUTION GCS is for reference only. Consult other clinical observations for diagnosis. Please refer to hospital policy regarding acceptable use of GCS. 19.2.1 Displaying the GCS Parameter Area To display the GCS parameter area, follow this procedure:
1. 2. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select the Main Menu quick key from the Display column select Tile Layout. Select the parameter area where you want to display the GCS score, and then from the popup list select GCS. The following figure shows the GCS parameter area. The display may be configured to look slightly different.
(4)
(1)
(2)
(3)
(5)
(6) 19 - 5
(1) GCS label
(2)
(3)
(4)
(5)
(6) Total score and level of consciousness. The color of the circle indicates the level of risk. Scoring time Scoring countdown: time to the next scoring Scoring interval Subscores E: eye opening V: verbal response M: motor response 19.2.2 Accessing the GCS Dialog Enter the GCS dialog in any of the following ways:
Select the GCS parameter area Select the GCS quick key. Select the Main Menu quick key from the CAA column select GCS.
(1)
(2)
(1) Subscore (2) Total score 19.2.3 Performing GCS Scoring To perform scoring, follow this procedure:
1. 2. From the Eye Opening area, Verbal Response area, and Motor Response area, respectively select an item that represents the patients status. Select OK to accept the total score. The following table lists the default score range and color of relevant consciousness level. Level Mild damage Moderate damage Severe damage Range 13-15 9 - 12 3 - 8 Color White Yellow Red 19 - 6 NOTE The GCS score range is adjustable. Refer to 25.4.2Setting GCS Threshold for Each Consciousness Level for the method of changing the high limit and low limit of each consciousness level. 19.2.4 19.2.5 19.3 Setting GCS Scoring Interval From the GCS dialog, select Interval to set GCS scoring interval. When the scoring interval is reached and you do not perform another scoring, the score will be invalidated and displayed as outline fonts. Reviewing GCS Trend Data From the GCS dialog, select Review to enter the Review dialog and view the GCS trend data from the Tabular Trends. ECG 24h Summary (Optional) The ECG 24h Summary provides ECG statistics of the current patient over the latest 24 hours. You can view the following information through the ECG 24h Summary:
Heart rate statistics Arrhythmia event statistics QT/QTc measurement statistics Maximum and minimum ST statistics of each lead Pacer statistics Typical ECG strips NOTE A license is required for the ECG 24h Summary function. The ECG 24h Summary is intended for the current patient. It is not intended for discharged patients. Pacer statistics is intended for paced patients. Patient data is saved, collected and displayed together in the ECG 24h Summary. Data displayed in the ECG 24h Summary is not recalculated. 19.3.1 Viewing the ECG 24h Summary To view the ECG 24h Summary, choose either of the following ways:
Select the ECG 24h Sum quick key. Select the Main Menu quick key from the CAA column select ECG 24h Summary. 19.3.2 Selecting Typical ECG Strips The Typical Strips area displays ECG strips of the following situations:
Maximum heart rate Minimum heart rate Four arrhythmia events You can select a typical ECG strip of each situation. For example, to select the typical ECG strip of asystole, follow this procedure:
1. 2. Select the currently displayed asystole strip. From the popup strips, select the desired strip as the typical strip of asystole. 19 - 7 19.3.3 Reviewing ECG Summary From the ECG 24h Summary dialog, you can review corresponding trends and events. Select the Heart Rate area to review HR graphic trends. Select the Max ST/Min ST area to review the current ST reference and ST graphic trends. Select the Pace area to review historic pace events. Select the QT area to review QT/QTc graphic trends. Select the Arrhythmia area to review arrhythmia statistics. For more information, refer to 18.2.9Arrhy Statistics Review Page. Select Full Disclosure to review ECG full disclosure waveforms. For more information, refer to 18.2.8Full Disclosure Review Page. 19 - 8 20 Calculation 20.1 Calculation Overview The monitor provides calculation functions. The calculated values, which are not directly measured, are computed based on the values you provide. The calculation function is independent of other monitoring functions and can therefore be used for patients being monitored by other monitors. Any operation in a calculation dialog does not affect the patient monitored by the current monitor. You can perform the following calculations:
Drug calculations Hemodynamic calculations Oxygenation calculations Ventilation calculations Renal calculations 20.2 Calculation Safety Information WARNING Decisions on the choice and dosage of drugs administered to patients must always be made by the physician in charge. The drug calculations are based on the values input; it does not check the plausibility of the calculation performed. Check that the entered values are correct and the calculated values are appropriate. Mindray assumes no responsibility for any consequences caused by wrong entries and improper operations. 20.3 Drug Calculations 20.3.1 Performing Drug Calculations To perform drug calculations, follow this procedure:
1. 2. 3. 4. Access the drug calculator by either of the following ways:
Select the Calculations quick key select the Drug tab. Select the Main Menu quick key from the Calculations column select Drug. Set Drug Name and Patient Category. If the dose of drug is weight dependent, you must input the patients weight. The dose calculation program has a library of commonly used drugs, while Drug A through Drug E are user defined. Enter the known values, for example Drug Amount and Solution Volume. Select Calculate. The calculated values are indicated by red arrows. NOTE If available, the patient category and weight from the Patient Demographics dialog are automatically entered when you first access drug calculation. You can change the patient category and weight. This will not change the patient category and weight stored in the patient demographic information. 20 - 1 20.3.2 Checking the Titration Table The titration table shows information on the currently used drugs. Use the titration table to see what dose of a drug your patient will receive at different infusion rates. To access the titration table, follow this procedure:
1. 2. 3. 4. Access drug calculator by either of the following ways:
Select the Calculations quick key. Select the Main Menu quick key from the Calculations column select Drug. Select the Titration Table tab. Select Dose Type to set the type of dose unit in the titration table. Select Interval to set the interval between two adjacent titration table items. You can select how to display the titration table:
Dose: the titration table is listed in the sequence of increased drug dose. Infusion Rate: the titration table is listed in the sequence of increased infusion rate. By default the resolution of the infusion rate is one (1). By selecting Exact Rate the resolution of the infusion rate can reach 0.01 so that you can display the infusion rate more accurately. 20.3.3 Drug Calculation Formula Description Dose Dose (weight based) Drug Amount Drug Amount (weight based) Duration Duration (weight based) Concentration Unit Dose/hr Dose/min Dose/kg/hr Dose/kg/min g series: mcg, mg, g unit series: Unit, KU, MU mEq series: mEq g series: mcg, mg, g unit series: Unit, KU, MU mEq series: mEq hr hr mcg/ml, mg/ml, g/ml, Unit/ml, KU/ml, MU/ml, mEq/ml Formula Dose = Infusion Rate Concentration Dose (weight based) = Infusion Rate Concentration/
Weight Drug Amount =Dose Duration Drug Amount (weight based) = Dose Duration Weight Duration = Amount/Dose Duration (weight based) = Amount/(Dose Weight) Concentration = Drug Amount/Solution Volume Solution volume Infusion rate ml ml/hr Volume = Infusion Rate Duration Infusion Rate = Dose/Concentration Infusion rate (weight based) gml/hr Infusion Rate = Dose Weigh/Concentration 20.3.4 Titration Table Calculation Formula Description Infusion Rate Infusion Rate (weight based) Dose Dose (weight based) Unit ml/hr ml/hr Dose/hr Dose/min Dose/kg/hr Dose/kg/min Formula Infusion Rate = Dose/Concentration Infusion Rate = Weight Dose/Concentration Dose = Infusion Rate Concentration Dose (weight based) = INF Rate Concentration/
Weight 20 - 2 20.4 Hemodynamic Calculations The monitor provides the hemodynamic calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.4.1 Performing Hemodynamic Calculations To perform hemodynamic calculation, follow this procedure:
1. 2. 3. Access hemodynamic calculation by either of the following ways:
Select the Calculations quick key Hemodynamics tab. Select the Main Menu quick key from the Calculations column select Hemodynamics. Enter the known values. For a patient who is being monitored, the currently measured values are automatically entered. Select Calculate. A calculated value greater than the normal upper limit is indicated by an up arrow . A calculated value lower than the normal lower limit is indicated by a down arrow . You can select Range to show the normal range of each parameter. 20.4.2 Input Parameters for Hemodynamic Calculations Input Parameter cardiac output heart rate pulmonary artery wedge pressure artery mean pressure pulmonary artery mean pressure central venous pressure end-diastolic volume height weight Label C.O. HR PAWP PMAP PA Mean CVP EDV Height Weight Unit L/min bpm mmHg mmHg mmHg mmHg ml cm kg NOTE If you enable Use PA-D as PAWP, PA-D value will be used to replace PAWP value for hemodynamic calculation. For more information, refer to 14.6.8Setting the Use PA-D as PAWP Switch. 20.4.3 Calculated Parameters and Formulas for Hemodynamic Calculations Calculated Parameters Label Unit Formula cardiac index body surface area stroke volume stroke index systemic vascular resistance systemic vascular resistance index C.I. BSA SV SVI SVR SVRI L/min/m2 C.I. (L/min/m2) = C.O. (L/min)/BSA (m2) m2 ml ml/m2 DS/cm5 BSA (m2) = Wt0.425 (kg) Ht 0.725 (cm) 0.007184 SV (ml) = 1000 C.O. (L/min)/HR (bpm) SVI (ml/m2) = SV (ml)/BSA (m2) SVR (DS/cm5) = 79.96 [APMAP (mmHg) - CVP
(mmHg)]/C.O. (L/min) DSm2/cm5 SVRI (DSm2/cm5) = SVR (DS/cm5) BSA (m2) 20 - 3 Calculated Parameters Label pulmonary vascular resistance pulmonary vascular resistance index left cardiac work left cardiac work index left ventricular stroke work left ventricular stroke work index PVR PVRI LCW LCWI LVSW LVSWI Unit DS/cm5 Formula P VR (DS/cm5) = 79.96 [PAMAP (mmHg) - PAWP
(mmHg)]/C.O. (L/min) DSm2/cm5 PVRI (DSm2/cm5) = PVR (DS/cm5) BSA (m2) kgm kgm/m2 gm LCW (kgm) = 0.0136 APMAP (mmHg) C.O. (L/
min) LCWI (kgm/m2) = LCW (kgm)/BSA (m2) LVSW (gm) = 0.0136 APMAP (mmHg) SV (ml) gm/m2 LVSWI (gm/m2) = LVSW (g.m)/BSA (m2) right cardiac work RCW kgm R CW (kgm) = 0.0136 PAMAP (mmHg) C.O. (L/
min) R CWI (kgm/m2) = RCW (kg.m)/BSA (m2) R VSW (gm) = 0.0136 PAMAP (mmHg) SV (ml) kgm/m2 gm right cardiac work index right ventricular stroke work right ventricular stroke work index ejection fraction End-diastolic volume index RCWI RVSW RVSWI EF EDVI End-systolic Volume ESV End-systolic Volume index ESVI gm/m2 R VSWI (gm/m2) = RVSW (gm)/BSA (m2)
%
ml/m2 ml ml/m2 EF (%) = 100 SV (ml)/EDV (ml) EDVI (ml/m2) = EDV (ml)/BSA (m2) ESV (ml) = EDV (ml) SV (ml) ESVI (ml/m2) = ESV (ml)/BSA (m2) 20.5 Oxygenation Calculations The monitor provides the oxygenation calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.5.1 Performing Oxygenation Calculations To perform oxygenation calculations, follow this procedure:
1. 2. 3. Access oxygenation calculation by either of the following ways:
Select the Calculations quick key Oxygenation tab. Select the Main Menu quick key from the Calculations column select Oxygenation. Enter the known values. For a patient who is being monitored, the currently measured values are automatically entered. Select Calculate. A calculated value greater than the normal upper limit is indicated by an up arrow . A calculated value lower than the normal lower limit is indicated by a down arrow . In the Oxygenation page, you can also perform the following operations:
Select Oxycont Unit, Hb Unit, and Pressure Unit. Then corresponding parameter values will be automatically converted and updated accordingly. Select Range to show the normal range of each parameter. 20 - 4 20.5.2 Input Parameters for Oxygenation Calculations Input Parameter cardiac output percentage fraction of inspired oxygen partial pressure of oxygen in the arteries partial pressure of carbon dioxide in the arteries arterial oxygen saturation partial pressure of oxygen in venous blood venous oxygen saturation hemoglobin respiratory quotient atmospheric pressure height weight Label C.O. FiO2 PaO2 PaCO2 SaO2 PvO2 SvO2 Hb RQ ATMP Height Weight Unit L/min
%
mmHg, kPa mmHg, kPa
%
mmHg, kPa
%
g/L, g/dl, mmol/L None mmHg, kPa cm, inch kg, lb 20.5.3 Calculated Parameters and Formulas for Oxygenation Calculations Calculated Parameters Label body surface area oxygen consumption arterial oxygen content venous oxygen content BSA VO2 CaO2 CvO2 Unit m2 ml/min ml/L, ml/dL ml/L, ml/dL Formula BSA (m2) = Wt0.425 (kg) Ht 0.725 (cm) 0.007184 VO2 (ml/min) = C(a-v)O2 (ml/L) C.O. (L/min)) CaO2 (ml/L) = 10 (0.0134 Hb (g/dl) SaO2 (%))
+0.031 PaO2 (mmHg) CvO2 (ml/L) = 10 (0.0134 Hb (g/dl) SvO2 (%))
+0.031 PvO2 (mmHg) arteriovenous oxygen content difference oxygen extraction ratio oxygen transport partial pressure of oxygen in the alveoli alveolar-arterial oxygen difference C(a-v)O2 ml/L, ml/dl C(a-v)O2 (ml/L) = CaO2 (ml/L) - CvO2 (ml/L) O2ER DO2 PAO2
%
ml/min mmHg, kPa O2ER (%) = 100C(a-v)O2 (ml/L)/CaO2 (ml/L) DO2(ml/min) = C.O. (L/min) CaO2(ml/L) PAO2 (mmHg) = [ATMP (mmHg) - 47 mmHg]
FiO2 (%)/100 - PaCO2 (mmHg) [FiO2 (%)/100 +
(1 - FiO2 (%)/100)/RQ]
AaDO2 mmHg, kPa AaDO2 (mmHg) = PAO2 (mmHg) - PaO2 (mmHg) capillary oxygen content CcO2 ml/L, ml/dl CcO2 (ml/L) = Hb (g/L) 1.34 + 0.031 PAO2
(mmHg) venous admixture QS/QT
%
QS/QT (%) = 100 [1.34 Hb (g/L) (1 - SaO2 (%)/100) +
0.031 (PAO2 (mmHg) - PaO2 (mmHg))]/[1.34 Hb (g/L) (1
- SvO2
(%)/100) + 0.031 (PAO2 (mmHg) - PvO2 (mmHg))]
oxygen transport index oxygen consumption DO2I VO2I ml/min/m2 ml/min/m2 DO2I (ml/min/m2) = CaO2 (ml/L) (C.O. (L/min)/
BSA (m2)) VO2I (ml/min/m2) = C (a-v) O2 (ml/L) (C.O. (L/
min)/BSA (m2)) 20 - 5 20.6 Ventilation Calculations The monitor provides the ventilation calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.6.1 Performing Ventilation Calculations To perform ventilation calculations, follow this procedure:
1. 2. Access ventilation calculation by either of the following ways:
Select the Calculations quick key Ventilation tab. Select the Main Menu quick key from the Calculations column select Ventilation. Enter the known values. For a patient who is being monitored, the currently measured values are automatically taken. If the anesthesia machine or ventilator is connected, measured values for ventilation calculation are also automatically entered. 3. Select Calculate. A calculated value greater than the normal upper limit is indicated by an up arrow . A calculated value lower than the normal lower limit is indicated by a down arrow . On the Ventilation page, you can also perform the following operations:
Select Pressure Unit. Then corresponding parameter values will be automatically converted and updated accordingly. Select Range to show the normal range of each parameter. 20.6.2 Input Parameters for Ventilation Calculations Input Parameter percentage fraction of inspired oxygen respiration rate partial pressure of mixed expiratory CO2 partial pressure of carbon dioxide in the arteries partial pressure of oxygen in the arteries tidal volume respiratory quotient atmospheric pressure Label FiO2 RR PeCO2 PaCO2 PaO2 TV RQ ATMP Unit
%
rpm mmHg, kPa mmHg, kPa mmHg, kPa ml None mmHg, kPa 20.6.3 Calculated Parameters and Formulas for Ventilation Calculations Calculated Parameters Label Unit Formula partial pressure of oxygen in the alveoli PAO2 mmHg, kPa PAO2 (mmHg) = [ATMP (mmHg) - 47 mmHg]
FiO2 (%)/100 - PaCO2 (mmHg) [FiO2(%)/100 + (1
- FiO2 (%)/100)/RQ]
alveolar-arterial oxygen difference oxygenation ratio arterial to alveolar oxygen ratio AaDO2 Pa/FiO2 a/AO2 mmHg, kPa AaDO2 (mmHg) = PAO2 (mmHg) - PaO2 (mmHg) mmHg, kPa Pa/FiO2(mmHg) = 100 PaO2 (mmHg)/FiO2 (%)
%
a/AO2 (%) = 100 PaO2 (mmHg)/PAO2 (mmHg) minute volume MV L/min MV (L/min) = [TV (ml) RR (rpm)]/1000 20 - 6 Calculated Parameters Label volume of physiological dead space Vd physiologic dead space in percent of tidal volume Vd/Vt Unit ml
%
Formula Vd (ml) = TV (ml) [1 - PeCO
(mmHg)/PaCO
(mmHg)]
2 2 Vd/Vt (%) = 100 Vd (ml)/TV (ml) alveolar volume VA L/min VA (L/min) =[TV (ml) - Vd (ml)] RR (rpm)/1000 20.7 Renal Calculations The monitor provides the renal calculation function and can save the results of up to 10 calculations, which are displayed in groups. 20.7.1 Performing Renal Calculations To perform renal calculations, follow this procedure:
1. 2. 3. Access renal calculation by either of the following ways:
Select the Calculations quick key select the Renal tab. Select the Main Menu quick key from the Calculations column select Renal. Enter the known values. Select Calculate. A calculated value greater than the normal upper limit is indicated by an up arrow . A calculated value lower than the normal lower limit is indicated by a down arrow . You can select Range to show the normal range of each parameter. 20.7.2 Calculated Parameters and Formulas for Renal Calculations Input Parameter urine pstassium urinary sodium urine plasm osmolality urine osmolality serum sodium creatinine urine creatinine blood urea nitrogen height weight Label URK URNa Urine Posm Uosm SerNa Cr UCr BUN Height Weight Unit mmol/L mmol/L ml/24 hrs mOsm/kgH2O mOsm/kgH2O mmol/L mol/L mol/L mmol/L cm kg 20 - 7 20.7.3 Calculated Parameters and Formulas for Renal Calculations Calculated Parameters Label Unit Formula urine sodium excretion URNaEx mmol/24 hrs urine potassium excretion URKEx mmol/24 hrs sodium potassium ratio clearance of sodium Na/K CNa
%
ml/24 hrs creatinine clearance rate Clcr ml/min fractional excretion of sodium osmolar clearance FENa Cosm free water clearance CH2O U/P osm BUN/Cr*
urine to plasma osmolality ratio blood urea nitrogen creatinine ratio urine-serum creatinine ratio
%
ml/min ml/hr None Mmol/L URNaEx (mmol/24 hrs) = Urine (ml/24 hrs) URNa (mmol/L)/1000 URKEx (mmol/24 hrs) = Urine (ml/24 hrs) URK
(mmol/L)/1000 Na/K (%) = 100 URNa (mmol/L)/URK (mmol/L) CNa (ml/24 hrs) = URNa (mmol/L) Urine (ml/24 hrs)/SerNa (mmol/L) Clcr (ml/min) = Ucr (mol/L) Urine (ml/24 hrs)/
[Cr (mol/L) (BSA (m2)/1.73) 1440]
FENa (%) = 100 URNa (mmol/L) Cr (mol/L)/
[SerNa (mmol/L) Ucr (mol/L)]
Cosm (ml/min) = Uosm (mOsm/kgH2O) Urine
(ml/24 hrs)/(Posm (mOsm/kgH2O) 1440) CH2O (ml/hr) = Urine (ml/24 hrs) [1 - Uosm
(mOsm/kgH2O)/Posm (mOsm/kgH2O)]/24 U/P osm = Uosm (mOsm/kgH2O)/Posm (mOsm/
kgH2O) BUN/Cr = 1000 BUN (mmol/L)/Cr (mol/L) U/Cr None U/Cr (mmol/L) = Ucr (mol/L)/Cr (mol/L)
*: BUN/Cr is a ratio under the unit of mol. 20 - 8 21 Recording 21.1 Recorder The thermal recorder records patient information, measurement data, and up to three waveforms. The monitor is configured with a built-in recorder.
(1)
(3)
(4)
(2)
(5)
(1)
(2)
(3)
(4)
(5) Start/Stop key: press to start a recording or stop the current recording. Module status indicator On: when the recorder works correctly. Off: when the monitor is switched off. Flashes: if an error occurred to the recorder. Paper outlet Recorder door Latch: pull it backward to open the recorder door. 21.2 Starting Recordings Recordings can be started manually or automatically. 21.2.1 Manually Starting Recordings To manually start a recording, you can either:
Press the Select hardkey on the front of the recorder to start a Realtime Segment Waveform Recording. on the current dialog to start a recording corresponding to that dialog or page. 21.2.2 Automatic Recordings In the following conditions, you can set the recorder to automatically start recording:
At a preset interval. For more information, see 21.5Setting up the Recorder. When a parameter alarm is triggered. For more information, see 25.3.9.3Enabling Automatic Recordings on an Alarm. 21 - 1 21.3 21.3.1 21.3.2 Stopping Recordings Recordings can be stopped manually or automatically. Stopping Recordings Manually To manually stop a recording, press the hardkey while the recorder is creating a strip. Stopping Recordings Automatically Recordings stop automatically in the following conditions:
The recording is completed. The recorder runs out of paper. The recorder has an alarm condition. The recorder module is removed from the monitor. The monitor is turned off. 21.4 Recording Related Flags You can find the following flags on the recording reports:
For automatically stopped recordings, there are two columns of asterisks * at the end of the report. For manually or abnormally stopped recordings, there is one column of asterisks * at the end of the report. If the parameter data is from external devices connected to the monitor via the BeneLink module, the parameter label is prefixed with the plus sign +. 21.5 Setting up the Recorder To configure the recorder for waveforms and printing intervals, follow this procedure:
1. 2. 3. 4. 5. 6. Select the Main Menu quick key from the Report column select Record Setup. In the Record Setup dialog, select the desired waveform for Waveform 1, Waveform 2 and Waveform 3 in turn. The recorder can record up to 3 waveforms at a time. Switch on or off IBP Overlap to enable or disable IBP recordings in the overlapping format. When the IBP Overlap is enabled: If two or more waveforms in the selected waveforms for recording are IBP waveforms, the IBP waveforms will be recorded in the overlapping format. When the IBP Overlap is disabled: IBP waveforms will be recorded without overlap. Select Length to set the duration of real-time recording. Select Interval to set the time interval for automatic recording. Select Paper Speed to set the speed for recording waveforms. 21.6 Clearing Recording Tasks To clear recording tasks, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select Record Setup. In the Record Setup dialog, select Clear All Tasks. This clears all queued recording tasks and stops the current recording. 21 - 2 21.7 Loading Paper To load paper, follow this procedure:
1. 2. 3. Use the latch at the upper right of the recorder door to pull the door open. Insert a new roll into the compartment as shown below. Feed the paper through and pull some paper out from the top of the roller. Close the recorder door. recorder may be unable to print, or poor print quality may result. CAUTION Use only specified thermal paper. Otherwise, it may cause damage to the recorders printhead, the Never pull the recorder paper with force when a recording is in process. Otherwise, it may cause Do not leave the recorder door open unless you are reloading paper or cleaning a paper jam. damage to the recorder. 21.8 Removing Paper Jam If the recorder works incorrectly or produces unusual sounds, check if there is a paper jam. If a paper jam is detected, follow this procedure to remove it:
1. 2. 3. Open the recorder door. Take out the paper and tear off the draped part. Reload the paper and close the recorder door. 21.9 List of Recording Reports The recorder can output the following reports:
Realtime reports Realtime Segment Waveform Recording Realtime Continuous Waveform Recording Auto Realtime Record ST Record QT Record 12-Lead Interpretation Record Record on Alarm Report 12-Lead Waveform Record History reports Event Detail Full Disclosure Detail Record 12 Lead Review Record 21 - 3 22 Printing 22.1 Supported Printer The monitor can output patient reports via a connected network printer. The monitor supports the following printers:
HP LaserJet Pro M202dw HP LaserJet Enterprise M605 HP LaserJet P4015n HP LaserJet Pro 400 M401n HP LaserJet 600 M602 HP LaserJet Enterprise M608 NOTE For more details about the printer, refer to the document accompanying the printer. With product upgrades, the monitor may support additional printers without prior notice. If you have any doubts about the compatibility of the printer used with this monitor, contact Mindray. 22.2 End Case Reports 22.2.1 Printing the End Case Report To print the end case report, choose one of the following ways:
Select Print from the End Case Report menu. Select Print End Case Report when you discharge a patient. Select the End Case Report quick key. 22.2.2 Setting a Report as An End Case Report The following reports can be set as end case reports:
Tabular Trends Report Graphic Trends Report Event Report 12-lead Interpretation Alarm Limits Report Realtime Report ECG Report To set a report as an end case report, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select End Case Report. From the Select Reports page, select the desired report tab, for example ECG Report. 22 - 1 22.2.3 Configuring End Case Reports To configure end case reports, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select End Case Report. From the Report Setup page, set the following end case reports:
Select the Tabular Trends Report, Graphic Trends Report, Realtime Report, and ECG Report tab, and set these end case report by referring to section 22.7Viewing Printer Status. Select the Event Report tab, and select the event that needs to be printed. Select the 12-Lead Interpretation tab, and set the switch of Median Complex, Measurements, Interpretation, or Interpretation Summary. For other settings, refer to section 22.7Viewing Printer Status. 22.2.4 Setting the End Case Report Period To set the end case report print period, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select End Case Report. From the Select Reports page, set the Period. NOTE End case report print period is calculated from the patient discharged time to the configured period. Period setting is applicable to all of the end case reports. 22.3 22.3.1 Manually Starting a Printing Task This section describes different methods for manually printing a report. Printing from the Screen The is not enough information to begin the report, or the printer has not been set up. button will be shown at the top of dialogs that have associated reports. If the button is gray, then there When the icon is white, pressing it opens a Print Setup dialog or starts printing a report. If the Print Setup dialog is entered, configure the report and press Print to start printing. 22.3.2 Printing Realtime Reports Select the Print quick key to print a realtime report. You can also print a realtime report from the Report Setup dialog. For more information, see 22.3.3Printing Most Common Reports. 22.3.3 Printing Most Common Reports The following most common reports can be printed:
ECG Report Realtime Report Tabular Trends Report Graphic Trend Report. To print these reports, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the Report column select Report Setup. Select the desired report tab. Check the settings. Select Print. 22 - 2 22.4 Automatically Printing Reports When a parameter alarm switch is set to on and an alarm is triggered for this parameter, you can set the monitor to automatically print a Print on Alarm Report. To do so, follow this procedure:
1. Access alarm related tabs such as the Alarm tab for a parameter in one of the following ways:
Select the Alarm Setup quick key at the bottom of the screen. Select the parameter or waveform area of the desired parameter select the Alarm tab. Select the Parameters Setup quick key at the bottom of the screen select the desired parameter select the Alarm tab. 2. Switch on Alarm outputs for desired parameters. 22.5 Stopping a Printing Task To stop a printing task, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select Print Queue. Select desired printing tasks and then select Delete. Alternately, select Delete All to stop all the printing tasks. 22.6 Configuring Reports This section focuses on how to configure ECG reports, realtime reports, tabular trends reports, and graphic trends reports. 22.6.1 Configuring ECG Reports To configure ECG reports, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Report column select Report Setup. Select the ECG Report tab. Set the desired options. The following table explains some of the less familiar options. Menu item Function Description Speed Auto Interval Set the print speed of ECG waveforms 25 mm/sec: prints 25 mm of ECG waveform per second. 50 mm/sec: prints 50 mm of ECG waveform per second. Defines the spacing between the ECG waveforms on a printout On: automatically adjusts the space between waveforms to avoid overlapping. Off: each waveform area has the same size on a printout. Note: This setting is only relevant when 121 is selected for 12-Lead Format. 12-Lead Format Select the format of 12-
lead ECG waveforms on a printout. 121: displays 12-lead ECG waveforms on one page in one column. 62: displays 12-lead ECG waveforms on one page in two columns, with 6 lines in each column. 62+1: displays 12-lead ECG waveforms on one page in two columns, with 6 lines in each column, and one rhythm lead waveform at the bottom. 34+1: displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and one rhythm lead waveform at the bottom. 34+3: displays 12-lead ECG waveforms on one page in 4 columns, with 3 lines in each column, and three rhythm lead waveforms at the bottom. 22 - 3 Menu item Function Description Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Select the lead that will be used as Rhythm Lead 1, 2, or 3. I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Format sequence Note: This setting is only relevant when 62+1,34+1, or 34+3 is selected for 12-Lead Format. Select the recording method of ECG report generated by auto measurement Sequential: 12-lead ECG data are recorded sequentially and displayed in 3 lines and 4 columns with 2.5 seconds of ECG data for each column. Simultaneous: Record simultaneous 12-lead ECG data. NOTE When ECG Lead Set is set to 3-Lead, then ECG report cannot be printed. 22.6.2 Configuring Realtime Reports To configure tabular realtime reports, follow this procedure:
1. 1. 2. Select the Main Menu quick key from the Report column select Report Setup. Select the Realtime Report tab. Set the desired options. The following table explains some of the options. Menu item Function Description Select Waveform Select the desired waveform to print Current Waveforms: prints the realtime report for the currently displayed waveforms and all the currently measured parameter values. Selected Waveforms: prints the realtime report for the waveforms configured in the Select Waveform dialog, accessed by clicking the Select Waveform button. 22.6.3 Configuring Tabular Trends Reports To configure tabular trends reports, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Report column select Report Setup. Select the Tabular Trends Report tab. Set the desired options. The following table explains some of the options. Menu Item Function Description Time Period Select the time before which a tabular trends report will be printed
/
Select the period during which a tabular trends report will be printed. Auto: one page of a tabular trends before the current time will be printed at the selected Interval. All: all stored tabular trends will be printed at the selected Interval. 30 min to 96 hrs: 30 min to 96 hrs of tabular trends before the selected Time will be printed at the selected Interval. 22 - 4 Menu Item Function Description Interval Select the resolution of the tabular trends printed on a report. Report Format Select the printing principle. NIBP, EWS, GCS, C.O.: at an interval of acquiring the values of selected parameter. Auto: using the Interval setting of the Tabular Trends review page. 5 sec to 3 hrs: the tabular trends will be printed at the interval of 5 sec to 3 hrs. Parameter Oriented: print one page span of report with parameters listed by row and time listed by column when Interval is set to Auto. Time Oriented: print one page span of report with time listed by row and parameter listed by column when Interval is set to Auto. Note that Interval on Auto only limits the number of rows or columns for Time. The report may have multiple pages to accommodate the number of parameters. To limit the parameters, change the Trend Group. 22.6.4 Configuring Graphic Trends Reports To set graphic trends reports, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Report column select Report Setup. Select the Graphic Trends Report tab. Set the desired options. Menu Item Function Description Period Select the period during which a graphic trends report will be printed. Auto: one page of a graphic trends before the current time will be printed. All: all stored graphic rends will be printed.. 30 min to 96 hrs: 30 min to 96 hrs of graphic trends before the selected Time will be printed. 22.7 Viewing Printer Status You can view the status of the most recent ten printing tasks in the Print Queue dialog. To view the status of printing tasks, follow this procedure:
1. 2. Select the Main Menu quick key from the Report column select Print Queue. View the status of printing tasks in the Print Queue dialog. Each printing task includes the following information:
Print time Report title Printer name (when using the printer server) or IP address (when using the network printer) Printing status, for example, printing, failed, retrying, and waiting. 22.8 Printer Out of Paper When the printer runs out of paper, the print request will remain incomplete. If there are too many print jobs that remain incomplete, then a printer error may occur. To resolve the error, install paper. Some print requests may be lost if the incomplete tasks overflow the printer buffer. Missing or lost reports must be recreated and printed. To reduce risks of printer errors, maintain enough paper in the printer. 22 - 5 22.9 List of Reports The printer can output the following reports:
Realtime reports Realtime Report Freeze Report ECG Report (5-lead, 6-lead, 12-lead) 12-Lead Interpretation Report (realtime) Print on Alarm Report Alarm Limits Report Titration Table Report Hemodynamic Calculation Report Oxygenation Calculation Report Ventilation Calculation Report Renal Calculation Report ST Report (Realtime) QT Report (Realtime) OxyCRG Report C.O. Measure Report PAWP Report ECG 24h Summary & Typical Strips Device Integration - Loops Report (BeneLink) History reports Tabular Trends Report Graphic Trends Report Event List Report Event Detail Report Full Disclosure Overview Report Full Disclosure Detail Report 12-Lead Review Interpretation Report (review) ST Report (review) OxyCRG Report (review) End Case Report End Case Report - Realtime Report End Case Report -ECG Report End Case Report - Tabular Trends Report End Case Report - Graphic Trends Report 22 - 6 23 Using the On-Screen Timers The monitor has a Timer function to notify you when a preset time period is expired or how much time has elapsed. You can simultaneously display up to four timers. 23.1 Displaying Timers To display a timer, follow this procedure:
1. 2. Access Tile Layout in either of the following ways:
Select the Screen Setup quick key select the Tile Layout tab. Select the Main Menu quick key from the Display column select Tile Layout. Click the numeric tile area where the timer is to be displayed, and then select a timer from the popup list. 23.2 Controlling the Timer The timer provides the following controls, depending on the state and settings of the timer:
Start: starts the timer. Pause: pauses the timer. Resume: resumes the timer. Reset: clears the timer. 23.3 Setting the Timer You can set each timer independently. To set the timer, follow this procedure:
1. 2. 3. 4. 5. Select the timer area to enter the Timer Setup dialog. Set Timer Type:
Normal: The timer has a single and defined run time, and stops with a notification beep when the run time is reached. Advanced: The timer has a single and defined run time. When the run time is reached, the timer makes a notification beep and continuously displays the time beyond the end of run time. Cycled: The timer has a single and defined run time. When the run time is reached, the timer makes a notification beep and restarts automatically. The number of elapsed cycles is also displayed on the left of the Timer tile. Unlimited: The timer displays the time elapsed since the timer was started. Clock: The timer displays the system time. Set Direction. Up: the timer counts up, from zero to Run Time. Down: the timer counts done, from Run Time to zero. Set Run Time. Set Reminder Volume. A progress bar is shown with the run time. When the remaining time is 10 seconds, the monitor issues a reminder tone and the timer flashes in red, prompting you that the run time is about to expire. NOTE You cannot change timer settings, other than Reminder Volume when a timer is running. You can set Direction, Run Time, and Reminder Volume only for normal, advanced, and cycled timers. 23 - 1 24 Managing Configurations 24.1 Configuration Introduction When performing continuous monitoring on a patient, the clinical professional often needs to adjust the monitors settings according to the patients condition. The collection of all these settings is called a configuration. The system configuration items can be classified as: parameter configuration items, conventional configuration items, and user maintenance items. Allowing you to configure the monitor more efficiently, the monitor provides different sets of configurations to accommodate the varying patient categories and departments.You can change some settings from a certain set of configuration and then save the changed configuration as a user configuration. The default configurations provided for your monitor are department-oriented. You can choose either from:
General OR ICU Neonatology CCU Each department has three different sets of configurations tailored for adult, pediatric and neonatal patients respectively. WARNING The configuration management function is password protected. The configuration management tasks must be performed by clinical professionals. 24.2 Changing the Department If the current department configuration is not the one you want to view, you can change the department by following this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the Configuration column select Manage input the required password select Select Change Department. Select a department. Select OK. CAUTION Changing the department will delete all current user configurations. 24.3 Setting Default Patient Category To set the default patient category when admitting a new patient, follow this procedure:
1. 2. Select the Main Menu quick key from the Configuration column select Manage input the required password select Set Default Patient Category. 24 - 1 24.4 Setting Default Configuration The monitor will load the pre-set default configuration in the following cases:
A patient is admitted. A patient is discharged. Patient category is changed. To set the default configuration, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Configuration column select Manage input the required password Select Select Select Default Config. Select Load the Latest Config or Load Specified Config. When you select Load Specified Config, the restored configuration is subject to the patient category
(adult, pediatric or neonate). This configuration can be either factory configuration or a saved user configuration. As an example, select Default Adult Config and then select Factory Default or user configuration(s). When you select Load the Latest Config, the latest configuration is loaded when the monitor is started or a patient is admitted. 24.5 Saving Current Settings Current settings can be saved as a user configuration. Up to 10 user configurations can be saved. To save current settings, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the Configuration column select Manage input the required password Select Select Save Current Settings. Input the configuration name. Select OK to save current settings as a user configuration. 24.6 Deleting a Configuration To delete a configuration, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Configuration column select Manage input the required password Select Select Delete Configuration. Select the configuration you want to delete:
In the Delete Configuration dialog, selecting Local tab shows the existing user configurations on the monitor. In the Delete Configuration dialog, selecting USB Drive tab shows the existing user configurations on the USB drive. 4. 5. Select Delete. Select OK. 24 - 2 24.7 Transferring a Configuration When installing several monitors with identical user configurations, it is not necessary to set each unit separately. Use a USB drive to transfer the configuration from monitor to monitor. 24.7.1 Exporting a Configuration To export the current monitors configuration, follow this procedure:
1. 2. 3. 4. 5. Connect the USB drive to the monitors USB port. Select the Main Menu quick key from the Configuration column select Manage input the required password Select Select Export Configuration. Select the configurations and User Maintenance Settings to export. Select Export. 24.7.2 Importing a Configuration To import the configuration from the USB drive to the monitor, follow this procedure:
1. 2. 3. 4. 5. Connect the USB drive to the monitors USB port. Select the Main Menu quick key from the Configuration column select Manage input the required password Select Select Import Configuration. Select the configurations and User Maintenance Settings to import. Select Import. 24.7.3 Loading a Configuration You may make changes to some settings during operation. However, these changes or the pre-selected configuration may not be appropriate for the newly admitted patient. Therefore, the monitor allows you to load a desired configuration to ensure that all the settings are appropriate for your patient. To load a configuration, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the Configuration column select Load. Select the desired configuration. Select the configuration on this monitor in the Local page. Select the configuration on the USB drive in the USB Drive page. Select Load. NOTE The monitor may configure some settings by default when you load a configuration of different software version with the current configuration. 24.8 Printing Configurations To print both factory configurations and user configurations, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the Configuration column select Manage input the required password select Select Print Configuration. Select desired configurations. Select Print. 24 - 3 24.9 Modifying Configuration Password To modify the configuration password, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the Configuration column select Manage input the required password Select
. Select Modify Password. Respectively input the old password and new password. Select OK. 24 - 4 25 Password-protected User Settings This chapter describes the password-protected functions accessed in the Maintenance dialog. 25.1 Setting the Device Location 25.1.1 Setting Monitor Information To set monitor information, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Device Location tab. Input monitor name, facility name and department name. 25.1.2 Setting Monitor Location If your monitor is installed at a fixed position, or you do not need clinicians to change the room number and bed number, you can set Monitor Location to Fixed. To set the monitor location, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Device Location tab. Set Location. Fixed: the Patient Management dialog displays Bed No. and Room No., but you cannot change them. Unfixed: you can change Bed No. and Room No. from the Patient Management dialog. Input the room number and bed number. NOTE If Location is set to Unfixed, Bed No. and Room No. are cleared from the Device Location tab each time you discharge a patient. 25.2 Changing Patient Management Settings 25.2.1 Selecting Displayed Patient Information You can define which items can be displayed and edited from the Patient Management tab. To do so, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Patient Management tab. Select the fields you want to display in the Patient Management dialog. If necessary, select the customized fields and input names for these fields. NOTE If the monitor is connected with the CMS, the patient information items and customized fields are loaded from the CMS. 25 - 1 25.2.2 Auto Discharging a Patient after Monitor Power Off You can let the monitor automatically discharge after the monitor has been switched off for a period of time. To set the time period of discharging a patient, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Patient Management tab select the Discharge tab. Select a time for Auto Discharge When Power Off. The monitor will automatically discharge the patient when it is turned off for the designated period of time. The default is Never. That is to say the monitor will not automatically discharge a patient, regardless of how long the monitor has been switched off. 25.2.3 1. Selecting Query Criteria for Searching Patients in ADT Server You can define which criteria can be used to search patients in the ADT server. To do so, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Patient Management tab ADT Query tab. Select the query criteria as desired. 2. 3. 25.2.4 Setting Patient Location Options for the Discharge Screen To set options for patient location, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Patient Management tab. Select the Location tab. Input or edit patient location options. 25.2.5 Hiding Patient Name To hide patient name on specific screens, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Patient Management tab. Select the Display tab. Set the following switches as desired:
Switch off Primary Screen Display Full Name: does not display patient name in the patient information area on the primary display. Switch off Remote View Display Full Name: does not display patient name in the patient information area on the remote monitors when this monitor is viewed by other monitors. Switch off Remote View Bedlist Display Full Name: does not display patient name in bed list on the remote monitors when this monitor is viewed by other monitors. 25.2.6 Select Whether a Prompt is Required When Auto Deleting Discharged Patients The monitor automatically delete earlier discharged patients when the memory is limited. You can select whether an alarm is issued when discharged patients are automatically deleted and the monitor memory is very low. 1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Set the Review tab Discharged Patients tab. Configure the alarms as needed:
. 25 - 2 Prompt on patient auto deleted: an alarm is issued when the monitor automatically deletes earlier discharged patients. Alarm on storage is nearly full: selects whether an alarm is issued when the monitor memory is very low and the priority of this alarm. 25.3 Changing the Alarm Settings 25.3.1 Setting Alarm Tone Properties 25.3.1.1 Setting the Minimum Alarm Volume To set the minimum alarm volume, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Audio tab. Set Minimum Alarm Volume. 25.3.1.2 Setting the Audible Alarm Tone Pattern You can distinguishes the heart beat tone, pulse tone, and keystroke tone by frequency. You can choose any of the three tone patterns: ISO, Mode 1, and Mode 2. For more information, see 7.3.3Alarm Indicators. To set the alarm tone pattern, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Audio tab. Set Alarm Sound to ISO, Mode 1or Mode 2. 25.3.1.3 Setting the Interval between Alarm Sounds If you choose the ISO pattern, you can change the interval between alarm tones. To change the interval between alarm tones, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Audio tab. Set High Alarm Interval, Med Alarm Interval, and Low Alarm Interval. 25.3.1.4 Setting Alarm Volume Escalation The monitor provides the function of automatically escalating the alarm tone volume. When this function is enabled, if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone increases automatically. To set the alarm volume escalation, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Audio tab. Set Auto Increase Volume. 2 Steps: if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by two levels. 1 Step: if an alarm is not reset within the designated delay time after the alarm occurs, the alarm volume automatically increases by one level. 25 - 3 Off: if an alarm is not reset within the designated delay time after the alarm occurs, the volume of the alarm tone does not change. 4. Select Increase Volume Delay to set the delay time of alarm volume escalation. NOTE The alarm volume escalation function is not applied to the latched alarms. 25.3.2 Setting Alarm Pausing and Resetting Properties 25.3.3 Defining the Pause Function You can either pause alarms or pause alarm tones. This depends on the pause setting. To set the pause function, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Set Pause to Alarm Pause or Audio Pause. The default setting is Alarm Pause. 25.3.3.1 Setting the Alarm Pause Time/Alarm Tone Pause Time The alarm pause time or alarm tone pause time can be set to 1 min, 2 min, 3 min, or Permanent. The default audio pause time is two minutes. To set the alarm tone pause time, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Set Pause Time. 25.3.3.2 Setting the Priority of Audio Paused Alarms To select alarm of what priority can be paused or alarm sound of what priority can be paused, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Set Pause Priority. All: pressing the Alarm Pause quick key pauses all alarms. Med & Low: pressing the Alarm Pause quick key pauses alarms of medium and low priority. The high priority alarms will not be paused. Disable: the Alarm Pause quick key is disabled. 25.3.3.3 Disabling the Options of Prolonging Alarm Pause Time/Alarm Tone Pause Time To disable specific options for the clinician when prolonging alarm pause time or the alarm tone pause time, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Switch off Pause 5 min, Pause 10 min, or Pause 15 min. 1. 2. 3. 25 - 4 25.3.3.4 Setting Alarm Light Status on Alarm Reset When the alarm system is reset, the monitor presents the alarm light by default , but you can switch off the alarm light. To change the alarm light setting, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Set Alarm Light. On When Reset: when the alarm system is reset, the alarm tones of the current alarms are switched off, but the alarm lamp remains flashing. Off When Reset: when the alarm system is reset, both the alarm tone and alarm lamp of the current alarms are switched off. 25.3.3.5 Setting the Reminder Tones When the alarm volume is set to zero, or the alarm is reset or switched off, the monitor issues a periodical reminder tone. The reminder tone is enabled by default. To set the reminder tone, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Pause/Reset tab. Set Alarm Reset Reminder and Alarm Off Reminder. On: the monitor issues reminder tones at a designated interval. Re-alarm: if the alarm condition persists the acknowledged alarms marked with will be re-
generated after the designated reminder tone interval . Off: the monitor does not issue reminder tones at a designated interval. The acknowledged alarms marked with will be silenced. 4. Set Reminder Interval to 10 min, 5 min, 3 min, 2 min, or 1 min. 25.3.4 Latching Physiological Alarms To latch physiological alarms, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Latching tab. Select how you want to latch the alarms. Alarm latching rules are as follows:
You can separately latch visible alarm signals and audible alarm signals. Latching audible alarm signals simultaneously latches the corresponding visible signals. Selecting alarms of lower priority simultaneously latches higher priority alarms. Switching V-Tach Latching Lock off allows you to switch on or off V-Tach Latching. When V-Tach Latching Lock is switched on, V-Tach latching follows the setting of Lethal alarm latching and you cannot control V-Tach Latching. 25 - 5 25.3.5 Changing Remote Alarm Settings 25.3.5.1 Resetting Alarms for Remote Devices You can reset the alarms occurring on the remote devices that are viewed on the Remote View screen of the monitor. To enable this function, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab Remote View tab. Switch on Reset Remote Bed Alarms. Then the Alarm Reset button appears on the bottom left of the Remote View screen. To reset any remote device alarms, the clinician may now select the Alarm Reset button at the bottom of the Remote View screen. NOTE You can reset remote device alarms only if the Alarm Reset By Other Bed switch is on at the remote devices and alarms are occurring on the remote device. 25.3.5.2 Authorizing the Alarm Reset to Other Devices Alarms on your monitor can be reset by remote devices if you enable this function. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab Remote View tab. Switch on Alarm Reset By Other Bed. 25.3.5.3 1. Selecting the Alarm Reminder for Remote Devices You can configure what alarm indicators are necessary for the remote devices. To do so, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab Remote View tab. Select Alarm Reminder:
2. 3. Visible + Audible: the monitor provides visual alarm indication, and continuous audible alarm indication if the alarm persists at the remote device. Visible + Single Tone: the monitor provides visual alarm indication, and a single tone when the alarm occurs at the remote device. Visible Only: the monitor only provides visual alarm indication. 25.3.5.4 Presenting Alarm Sound for Remote Devices as per Alarm Priority You can configure what priority of remote device alarms are presented for audible notification. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab Remote View tab. Select Alarm Priority:
. All: the monitor sounds if an alarm occurs. High & Med: the monitor sounds if a high or medium priority alarm occurs. High Only: the monitor sounds only if a high priority alarm occurs. 25 - 6 25.3.5.5 Setting the Tone Pattern for Alarms from Remote Devices The monitor provides the same alarm tone pattern for the remote device alarms as those for your monitor alarms. For more information on alarm tone pattern, see 7.3.3Alarm Indicators. To set the alarm tone pattern for the remote device alarms, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Remote View tab. Set Alarm Sound to ISO, Mode 1 or Mode 2. 25.3.5.6 Switching Off the Remote Device Disconnection Alarm The monitor can provide an alarm if remote devices, for example, a bedside monitor or a telemetry, are disconnected. By default, the function is enabled. To disable the alarm, follow this procedure:
1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab Remote View tab. Switch off Remote Disconnected Alarm. 25.3.6 Setting Nurse Call Properties 25.3.6.1 Selecting Alarms to be Sent to the Nurse Call System To set the type and priority of alarms that are sent to the nurse call system, follow this procedure:
1. 2. 3. 4. 5. 6. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Nurse Call tab. Select Signal Type Pulse: the nurse call signal is a pulse signal and each pulse lasts one second. When multiple alarms simultaneously occur, only one pulse signal is outputted. If an alarm occurs but the previous one is not cleared, a new pulse signal will also be outputted. Continuous: the nurse call signal lasts until the alarm ends. That is to say the duration of a nurse call signal is equal to that of the alarm condition. Select Contact Type to set the work mode of the nurse call relay. Select Alarm Priority to set the priority of alarms sent to the nurse call system. Select Alarm Type to set the type of alarms sent to the nurse call system. 25.3.6.2 Disabling the Receiving Call Help Function If a monitor in the same department calls for help, you can receive the calling signal. This function is enabled by default. To disable this function, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Nurse Call tab. Switch off Receive Call Help. 25 - 7 25.3.7 Changing Alarm Priority Settings 25.3.7.1 Setting the Priority of the ECG Lead Off Alarm To set the priority of the ECG lead off alarm, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Other tab. Set the priority of ECG Lead Off. 25.3.7.2 Setting the Priority of the SpO2 Sensor Off Alarm To set the priority of the SpO2 sensor off alarm, follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Other tab. Set the priority of SpO2 Sensor Off. 2. 3. 25.3.7.3 Setting the Priority of the IBP No Sensor Alarm To set the priority of the IBP no sensor alarm, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Other tab. Set the priority of IBP No Sensor. 25.3.7.4 Setting the Switch of the CMS and eGateway Disconnection Alarm You can choose whether to issue an alarm when the monitor is not connected or disconnected from the CMS/
eGateway. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Other tab. In the Other block, switch on or off CMS/eGW Disconnected Alarm. If CMS/eGW Disconnected Alarm is switched off, the Offline alarm is not presented when the monitor is not connected or disconnected from the CMS/eGateway. 25.3.7.5 Setting the Priority of the CMS and eGateway Disconnection Alarm To set the priority of the CMS and eGateway disconnection alarm, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Other tab. Set CMS/eGW Disconnected. 25.3.7.6 Setting the Switch of the SpO2 Desat Alarm Off You can choose whether switching off the SpO2 Desat alarm is permissible or not. To do so, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab select the Other tab. 1. 2. 25 - 8 3. Set SpO2 Desat Alarm Off. Disable: the SpO2 Desat alarm is always on. You cannot switch it off. Enable: you can switch off the SpO2 Desat alarm. For more information, see 11.6.1Changing the SpO2 Alarm Settings. WARNING If a clinician switches off the SpO2 Desat alarm, the monitor will not alarm when the patients SpO2 is extremely low. This may result in a hazard to the patient. 25.3.7.7 Setting the Switch of the Apnea Alarm Off You can choose whether switching off the apnea alarm is permissible or not. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab select the Other tab. Set Apnea Alarm Off. Disable: the zero RR alarm is always on. The clinician cannot switch it off. Enable: the clinician can switch off the zero RR alarm. For more information, see 10.5.1Setting the Resp Alarm Properties. WARNING If a clinician switches off the zero respiration rate alarm, the monitor will not issue the zero respiration rate alarm when that situation occurs. This may result in a hazard to the patient. Keep the patient under close surveillance. 25.3.8 Changing Alarm Delay Settings 25.3.8.1 Setting the Alarm Delay Time For continuously measured parameters, you can set the alarm delay time. If the alarm condition is resolved within the delay time, the monitor does not present the alarm. To set the alarm delay time, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Other tab. Set Alarm Delay. The setting of Alarm Delay is not applied to the zero respiration rate alarms and the ST alarms. You can set Zero RR Delay and ST Alarm Delay separately. 25.3.8.2 Setting the ST Alarm Delay Time 1. Select the Main Menu quick key from the System column select Maintenance input the required password select
. 2. 3. Select the Alarm tab Other tab. Set ST Alarm Delay. 25 - 9 25.3.9 Changing Other Alarm Settings 25.3.9.1 Setting the Lethal Arrhythmia Alarms Switch To allow a clinician to disable the lethal arrhythmia alarms, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Other tab. From the Other block, set Lethal Arrh Alarms Off as follows. Lethal Arrh Alarms Off is set to Disable by default. In this case, a clinician cannot switch off lethal arrhythmia alarms. If you set Lethal Arrh Alarms Off to enable, a clinician can switch off lethal arrhythmia alarms from the ECG dialog. For more information, see 8.6.4.1Changing Arrhythmia Alarm Settings. WARNING If any of lethal arrhythmia alarms are switched off, the ECG waveform area displays a message to indicate that corresponding alarms are off. If a clinician switches off all arrhythmia alarms, the monitor will not present arrhythmia alarms. Always keep the patient under close surveillance. 25.3.9.2 Setting the Intubation Time The default intubation time is 2 minutes. To change the intubation time, following this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab Other tab. Set the Intubation Mode Period. 25.3.9.3 Enabling Automatic Recordings on an Alarm Print on Alarm is set to Printer by default. To enable automatic recording via recorder when a parameter alarm is triggered, set Print on Alarm to Recorder. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Alarm tab select Other. Set Print on Alarm to Recorder. 25.3.9.4 Setting Arrhythmia Alarm Timeout Period The arrhythmia algorithm can disable alarm light and alarm tone for designated period of time when certain arrhythmia alarms are detected. To set the arrhythmia alarm timeout period, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Alarm tab select the Other tab. From the Other block, set Arrhy Shield Time. NOTE For the following alarms, alarm light and alarm tone cannot be disabled: HR high, HR low, Tachycardia, Bradycardia, Afib End, Irr Rhythm End. 25 - 10 The arrhythmia alarm timeout period is only applied to the medium priority chains and atrial fibrillation chain. For the alarms in the high priority chain, alarm tone and alarm light are presented as soon as the alarm condition is detected. Refer to 8.6.5.1Arrhythmia Alarm Chains for more information on the arrhythmia alarm chain. Alarm indication rules for alarms in the atrial fibrillation chain are the same with those for the medium priority chains. 25.4 Changing CAA Settings 25.4.1 Changing EWS Settings 25.4.1.1 Displaying and Managing the Operator ID To display the operator ID on the EWS screen, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the CAA tab select the EWS tab. Switch on Operator ID. Select Operator ID Timeout to set how long the operator ID will remain valid. NOTE The EWS tab is only available if a license for EWS is installed in the monitor. 25.4.1.2 Selecting the Default Scoring Tool To set the default scoring tool for different patient catalog, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the CAA tab select EWS tab. From the Select Default Score area, set Default Adult Score, Default Ped Score, and Default Neo Score. 25.4.1.3 Managing the Scoring Tools To manage the scoring tool, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the CAA tab select EWS tab. Select the Manage Score button. Delete local scoring tools: from the Local page, delete any unnecessary scoring tools. Import the desired scoring tools to the monitor: from the USB drive page, select the scoring tools on the USB drive, and then select Import. NOTE The monitor provide MEWS and NEWS by default. You cannot delete them. 25.4.2 Setting GCS Threshold for Each Consciousness Level You can configure the threshold and color of each consciousness level. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the CAA tab select the GCS tab. Set high limit, low limit for each level. 25 - 11 25.4.3 Defining the Hours of Nighttime for the ECG 24h Summary To define the nighttime for heart rate statistics, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the CAA tab ECG 24h Summary tab. Select From and To to define the beginning and end of Nighttime. 25.5 Changing Module Settings 25.5.1 Selecting the ECG Standard Select the ECG standard according to the leadwires you are using. To select the ECG standard, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab ECG tab. Set ECG Standard to AHA or IEC. 25.5.2 Changing the QTc Formula The monitor uses the Hodges correction formula by default to correct the QT interval for heart rate. To select the QTc formula, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab ECG tab. Set QTc Formula. Hodges:
QTc QT 1.75 HeartRate 60
+
=
(
) Bazett:
QTc QT
=
HeartRate
-----------------------------
60 1
---
2 Fridericia:
QTc QT
=
1
---
3 HeartRate
-----------------------------
60 Framingham:
QTc QT 154 1
+
=
60
-----------------------------
HeartRate 25.5.3 Setting the 12-Lead Order Switch To set whether to send the order number of 12-lead interpretation report to the hospital information system while saving the report, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab. Select the ECG tab. Set 12-Lead Order. 25.5.4 Calibrating ECG The ECG signal may be inaccurate due to hardware or software problems. As a result, the ECG waveform amplitude becomes greater or smaller. In that case, you need to calibrate the ECG module. To do so, follow this procedure:
25 - 12 1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab ECG tab. From the bottom left corner of the dialog select Calibrate. 25.5.5 Setting Parameter Measurement Timeout NIBP measurements become outline fonts after a preset time. This feature prevents older values being misinterpreted as current measurements. To adjust the timeout period for PAWP, C.O., and NIBP, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Module tab select Other. Set the timeout period for PAWP, C.O., and NIBP. 25.5.6 Setting Flow Rate (For Sidestream CO2 Module Without O2) When you are using the sidestream CO2 module without the O2 monitoring function to monitor a neonatal patient, you can select flow rate. To do so, follow this procedure:
1. 2. 3. 4. Ensure that the sidestream module without O2 is inserted in the monitor. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Module tab Other tab. Set CO2 Flow Rate For Neo. 25.6 Hiding Undesired Review Tabs If you do not need to review some items, you can hide them. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Review tab. From the Tabs page, Event page or Arrh Mark page deselect those not need to beavailable to clinicians during review. 25.7 Setting the Printer 25.7.1 Setting the Printer Properties To set a network printer, follow this procedure:
1. 2. 3. 4. 5. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Print tab. In the Printer tab, select Connection Type to choose whether you want to output patient reports via the print server or a network printer. If you set Connection Type to Print Server, perform the following settings:
to input the Print Server port. If the CMS is used as the Print Server, set Port to 6603. to input the Print Server name or IP address. Print Server Address: select Port: selects Printer: select the default printer. Resolution: select the resolution of the default printer. If you set Connection Type to Printer, perform the following settings:
Select Printer IP Address. Select to input the IP address of the desired network printer. 25 - 13 Select Paper Size. Select Resolution. After finishing configurations, you can select the Print Test Page button to verify that the printer works properly. 25.7.2 Setting Patient Information on General (Non-12-lead) Reports To set the patient information you want to display on general reports, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Print tab. Select the Report Layout tab. Select the desired items under Report Name. N/A indicates that this item is not displayed on a report. 25.7.3 Setting Patient Information on 12-lead ECG Reports To set the patient information you want to display on 12-lead ECG reports, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Print tab. select the ECG Report tab. On the right of the ECG Report page, select the desired patient information items. Patient ID, Patient Name, Age, and Gender are displayed on an ECG report by default. NOTE You can only set the patient information to display on the ECG report from the ECG Report page. Patient information configured in the Report Layout page is not applied to ECG reports. 25.7.4 Configuring the Name of PDF Files If you use the Print Server to output patient reports, you can use the PDF printer to output PDF format reports. To configure the name of PDF files, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Print tab PDF File Name tab. Select the desired items and their sequence under PDF File Name. N/A refers to no information. 25.7.5 Showing the Second Mark To set whether you want to show second marks on the report output by the printer, follow this procedure. 1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Print tab Other tab. Enable or disable Second Mark (Printer). 25.7.6 Setting the Arrhythmia Information to Output by the Recorder To set whether you want to include arrhythmia thresholds and QRS thresholds in the report output by the recorder, follow this procedure. 1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Print tab Other tab. 25 - 14 3. Enable or disable Arrhy Settings (Recorder). 25.7.7 Setting Parameter Unit To set parameter unit, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Set the Unit tab. Set unit for each parameter. 25.8 Enabling Auto Daylight Savings Time By default, daylight savings time is disabled. You need to manually enable the daylight savings time. To auto start the daylight savings time, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Time tab. Switch on Auto Daylight Savings Time. Adjust daylight savings time settings as necessary. NOTE If you enable Auto Daylight Savings Time you cannot manually switch it on or off from the System Time dialog. For more information, see 3.8.1Setting the Date and Time. 25.9 Viewing Version Information To view the system software version, module hardware and software version, and firmware version , follow this procedure:
1. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Version tab. 2. You can also view the system software version by selecting the Main Menu quick key from the System column select Version. 25.10 Checking Battery Information To check the battery information, follow this procedure:
1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Battery Information tab. 25.11 Changing Scanner Settings For the 2D barcode reader, you can change the scanner settings. 25.11.1 Establish the Relationship between Patient Demographics and 2D Barcode Fields (for the Mindray Custom 2D Barcode Reader) To configure 2D barcode reader, follow this procedure:
1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Scanner tab 2D Barcode tab. 25 - 15 3. Establish the relationship between the monitor data and hospitals barcode data for selectable patient demographics. For example, the monitor has an option of Ped for patient category. In your hospital barcode, the text may read as Pediatric. So input Pediatric for the field Ped to establish their relationship. 25.11.2 Setting the Barcode Reader Information To set the barcode reader information, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Scanner tab Scanner Info. tab. Set Scanner Type:
1D Scanner: select this option when using a 1D scanner or a 2D scanner other than the Mindray custom 2D scanner. 2D Scanner: select this option when using the Mindray custom scanner. NOTE When you set Scanner Type to 2D Scanner, default settings are applied to Data Encoding Type and DataParseMode. You do not need to change these setting. 25.11.3 Identifying the Barcode Reader (for the non-Mindray Custom 2D Barcode Reader) When you are using barcode readers other than the JADAK Flexpoint HS-1R or HS-1M, you should select the barcode reader from the USB device list, so that the monitor can identify the barcode reader. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Scanner tab Identifying Scanner tab. From the USB device list, select the barcode reader you are using. 25.11.4 Selecting Patient Information Read by the Barcode Reader (for the 2D Barcode Reader) To select desired patient information that will be read by the barcode reader, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Scanner tab Field tab. Select the patient information. The selected information can be read by the barcode reader. NOTE The patient information read by the barcode reader is dependent on the patient information encoded in the hospital's barcodes. 25 - 16 25.12 Configuring the Network You can connect the monitor to the central monitoring system (CMS), eGateway, and other monitors through wired LAN or wireless LAN. 25.12.1 Network Safety Information being accessed by unauthorized users. Mindray service personnel or authorized technicians. CAUTION Wireless network designing, deploying, debugging, and maintenance should be executed by Always set the wireless network according to local wireless regulations. Keep network authentication information, for example passwords, safe, to protect the network from Do not connect non-medical devices to the monitor network. RF interference may result in wireless network disconnection. Disconnecting from the network may result in CMS-destined data loss and function failure. Check the patient in case of network disconnection and solve the network problem as soon as possible. Ensure that the monitor IP address setting is correct. Changing the network settings may result in network disconnection. Contact your service personnel if there are any problems with the IP address. If wireless network signal is poor, there may be a risk of CMS-destined data loss. 25.12.2 Selecting a Network Type To select network type, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Type tab. Set Monitor to Auto, LAN1 IP, or WLAN according to your network type. The default is Auto, which means the monitor will automatically use LAN1 IP when detected and the available WLAN when LAN1 IP is not detected.. 25.12.3 Setting the Wired Network To set the wired network, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tabLAN1 IP tab. Select how to get the IP address. Obtain IP Address Automatically: the monitor automatically gets the IP address. Use the following Address: you need to input the IP address, Subnet mask, and Gateway. Select how to get the DNS address:
Obtain DNS Address Automatically: the monitor automatically gets the DNS address. Use the following DNS Address: you need to input the IP address of Preferred DNS server and Alternate DNS server. 25.12.4 Setting the Wireless Network To set the wireless network, follow this procedure:
1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab WLAN. 25 - 17 3. 4. 5. Input SSID, Security, and Password. Select the WLAN IP tab and select how to get the IP address. Obtain IP Address Automatically: the monitor automatically gets the IP address. Use the Following Address: you need to input the IP address, Subnet Mask, and Gateway. Select how to get the DNS address:
Obtain DNS Address Automatically: the monitor automatically gets the DNS address. Use the following DNS Address: you need to input the IP address of Preferred DNS server and Alternate DNS server. The monitor supports the following security methods: WPA2 PSK, WPA2 AES, CCKM AES, WPA PSK AES, WPA AES. Select the security method as desired. You may need to set more parameters for some security methods. After configuring the wireless network, select WLAN Network Test to verify that the wireless network can be properly connected. 25.12.5 Selecting WLAN Band and Channels
. 1. 2. 3. 4. The monitor supports 2.4 GHz and 5 GHz WLAN. To select WLAN band rate and channels, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab WLAN tab. Select the WLAN Setup button from the bottom left corner of the dialog. Set WLAN Band to Auto, 5G, or 2.4G according to the band you are using. The default is Auto, which means the monitor can automatically identify the WLAN band. Select Auth Server Type to set the type of authentication server. Set BGN Channel. Set AN Channel. 5. 6. 7. 25.12.6 Managing Certifications You can delete certifications from the monitor, or import certifications from the USB memory device. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab WLAN tab. Select the Certificate Management button from the bottom left corner of the dialog. From the Local tab, select certifications you want to delete from the monitor, and then select Delete. From the USB Drive tab, select certifications you want to import from the USB memory device, and then select Import. 25.12.7 Enabling Selecting a CMS To enable selecting a CMS, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab Central Station Setup tab. Switch on Select CMS. 25.12.8 Adding CMSs 1. You can add up to 30 central monitoring systems (CMS) for your monitor. To add CMSs, follow this procedure:
Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab Central Station Setup tab. 2. 25 - 18 3. Select Add Central Station, and then input the CMS name and IP address of this department. 25.12.9 Setting Multicast Parameters Multicast helps device discovery between monitors and other devices on the network. Devices in the same multicast group can be mutually discovered. To set multicast parameters, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tabDevice Discover tab. Set Multicast TTL. Set Multicast Address. 25.12.10 Setting the CMS IP or Gateway Address To set CMS address and the DNS name, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab Device Discover tab. Set Central Station Address to input the DNS name or IP address. The Center Station Address is 0.0.0.0 by default. That is to say that the monitor can be admitted by any CMS. If Center Station Address is not 0.0.0.0, the monitor can only be admitted by the specified CMS. The monitor will send unicast presence message to that CMS. If the CMS cannot discover the monitor via multicast, it can discover the monitor via unicast. If the monitor is connected to the CMS, the displayed IP of Connected Central Station is the IP of this CMS. NOTE If there is no central station for use with this monitor, then it can connect directly to the eGateway by entering the eGateway Address in the Central Station Address Field. 25.12.11 Setting the Network Service Quality Level To set the quality of service (QoS), follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tabQoS tab. Select QoS Level For Realtime Monitoring to set the service quality of network connection for realtime monitoring, for example parameter measurements and waveforms, alarms, etc. Select QoS Level For Others to set the service quality of network connection for non-realtime monitoring, for example history data, printing, etc. 25.12.12 Using the ADT Gateway The ADT (admit-discharge-transfer) gateway is normally deployed in the eGateway. You can obtain patient information from the hospital ADT server through the ADT gateway. To configure the ADT gateway, follow this procedure:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab ADT tab. Select Server Address to input the host name or IP address of the ADT gateway. Select Port to input the port of the ADT gateway. 25 - 19 ADT Query is switched off by default. You can load patient information to the monitor from the ADT server only when this function is enabled. After configuring the ADT gateway, select Network Test to verify that the ADT server is properly connected. 25.12.13 Sending Realtime Data, Waveforms and Alarms via HL7 Protocol You can send the realtime data, waveforms, and alarms from the monitor to the hospital servers via HL7 protocol. To do so, follow this procedure:
1. 2. 3. 4. 5. 6. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab HL7 Configuration tab. From the Data + Waveforms area, select Server Address to input the name or IP address for the server receiving the realtime data and waveform. Set Port. Switch on Send Data and Send Waveform, as needed.Set Data Interval. From the Alarms area, select Server Address to input the name or IP address for the server receiving the alarm data. Set Port. Switch on Send Alarms as needed. This page also display the server connection status. 25.12.14 Selecting Data Encryption Type To set data encryption type, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab Information Security tab. Select Encryption Connection Type to set data encryption type when connecting devices:
. Only Private Encryption: Mindray private encryption is used to encrypt the transmitted data. You cannot connect devices supporting SSL (secure sockets layer) encryption. SSL Encryption Priority: for devices supporting SSL encryption, SSL encryption is used when connecting the devices. For devices not supporting SSL encryption, private encryption is used when connecting the devices. 25.12.15 Disabling the Broadcasting Patient Demographics Function When viewing other patients, device location and patient information of remote devices are displayed in the remote device list by default. To protect patient privacy, you can disable the broadcasting patient demographics function to protect the monitor from sending patient information via broadcast. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select Network Setup tab Information Security tab. Switch off Broadcast Patient Demographics. Thus, patient information will not display in the remote device list. 25.13 MLDAP MLDAP refers to Mindray LDAP (Lightweight Directory Access Protocol). It is an independent process which can be installed on the eGateway or other application server (Windows). MLDAP provides user identity and authentication. The MLDAP server is connected with the hospital LDAP server. All monitoring devices are connected to the MLDAP server to implement identity and authentication for the following operations:
Changing alarm settings Changing arrhythmia settings Accessing the Maintenance dialog 25 - 20 25.13.1 Setting MLDAP To access the MLDAP server, you should set your monitor as follows:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab MLDAP tab. Set Server address and port of the MLDAP server. 25.13.2 Testing MLDAP Server Connection To test whether the monitor is properly connected with the MLDAP server, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Network Setup tab MLDAP tab. Select Network Test. 25.13.3 Selecting Password for User Authentication You can select what password is used when changing alarm settings, arrhythmia settings, and accessing the Maintenance dialog. To do so, follow this procedure:
1. 2. 3. 4. 5. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Authorization Setup tab. From the Maintenance area, set User Maintenance to select the password for accessing the monitors Maintenance dialog. Local Password: the monitors password for accessing the Maintenance dialog is required. User Password: the user name and password saved in the MLDAP server are required. From the Others area, set Alarm Setup: select the password for changing alarm settings. No Password: changing alarm settings is not password protected. Local Password: changing alarm switch, alarm limit, and alarm priority is password protected. The monitors password for changing alarm settings is required. User Password: changing alarm switch, alarm limit, and alarm priority is password protected. The user name and password saved in the MLDAP server are required. Set Arrhythmia: select the password for changing arrhythmia settings. No Password: changing arrhythmia settings is not password protected. Local Password: changing arrhythmia switch, alarm priority, and arrhythmia threshold is password protected. The monitors password for changing arrhythmia settings is required. User Password: changing arrhythmia switch, alarm priority, and arrhythmia threshold is password protected. The user name and password saved in the MLDAP server are required. From the Maintenance area, selecting Modify Local Password can change the monitors password for accessing the Maintenance dialog. From the Others area, selecting Modify Local Password can change the monitors password for accessing alarm settings and arrhythmia settings. 25.13.4 Setting the Password Timeout Period If you use the password saved in the MLDAP server to access the Maintenance dialog, alarm settings and arrhythmia settings, you can set the password timeout period. Once the timeout period is reached, you will need to re-enter the password. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Authorization Setup tab. Set Retention Time. 25 - 21 25.14 Defining Other Functions 25.14.1 Setting Notch Filter Frequency Set notch filter frequency according to the power line frequency of your country. To set notch filter frequency, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab. Set Notch Frequency to 50 Hz or 60 Hz according to the power line frequency. 25.14.2 Setting Mouse Sensitivity The mouse sensitivity is adjustable. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab. Set Mouse Sensitivity. 25.14.3 Setting the SpO2 Tone Mode The monitor adjusts the QRS tone (pitch tone) according to the SpO2 values. To set the SpO2 tone mode, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select
. Select the Other tab. Set SpO2 Tone to Mode 1 or Mode 2. The pitch changes more rapidly in Mode 2 than in Mode 1, as saturation levels change. The SpO2 tone mode chart for SpO2 between 40% to 100% is as follows:
NOTE It is highly recommended to use the same SpO2 tone mode for the same monitors in a single area to prevent issues arising from inconsistent operation. 25 - 22 25.14.4 Selecting the Language To set the user interface (UI) language, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab Set Language. 25.14.5 Switching On or Off a Parameter If there is no Parameters On/Off tab in the Screen Setup dialog then setting parameter switches is password protected. Follow this procedure to set parameter switches:
1. 2. 3. 4. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab. Select Parameters On/Off. Enable or disable desired parameters. When a parameter is switched off, the monitor stops data acquisition and alarming for this measurement. NOTE When a parameter is manually switched off and the corresponding parameter module is plugged in, you cannot monitor this parameter. 25.14.6 Setting If Setting Parameter Switches is Protected You can set whether setting parameter switches is password protected. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab. Switch on or off Parameters On/Off Protected. 25.14.7 Setting If Parameter Switch is Influenced by Configuration You can set if the settings of parameter switches are influenced by loading a configuration. To do so, follow this procedure:
1. 2. 3. Select the Main Menu quick key from the System column select Maintenance input the required password select Select the Other tab. Switch on or off Parameters On/Off Config Influenced. 25 - 23 26 Battery 26.1 Battery Introduction This monitor is designed to operate on battery power when the mains power is not available. The monitor uses mains power as primary power source. In case of mains power failure, the monitor automatically runs on the battery power. NOTE If the mains power fails and the monitor runs on battery power, the display brightness automatically lowers to the value of Brightness on Battery (set in Screen Setup Display). You can manually adjust the display brightness as required. 26.2 Battery Safety Information explosion. WARNING Keep batteries out of the reach of children. Use only Mindray specified batteries. Use of a different battery may present a risk of fire or Keep the batteries in their original package until you are ready to use them. Do not expose batteries to liquid. Do not crush, drop or puncture the battery. Mechanical abuse can lead to internal damage and internal short circuits. If a battery has been dropped or banged against a hard surface, whether damage is externally visible or not, remove the battery from use and dispose of it properly. If the battery shows signs of damage or signs of leakage, replace it immediately. Batteries should be charged only in this monitor. Extremely high ambient temperature may cause battery overheat protection, resulting in monitor shutdown. The lithium-ion battery has a service life of three years. Replace the battery when it reaches the end of its service life. Failure to replace the battery may cause serious damage to the equipment from battery overheating. Do not open batteries, heat batteries above 60 C, incinerate batteries, or short battery terminals. They may ignite, explode, leak or heat up, causing personal injury. CAUTION Remove the battery before shipping the monitor or when it will not be used for an extended period of time. 26.3 Battery Preparation The monitor can be configured with the non-smart and smart batteries based on your needs. Before installing the battery, you should get familiar with battery specifications. For more information, see A.4.2Battery Specifications. 26 - 1 Lithium batteries replaced by inadequately trained personnel could result in a hazard (such as excessive temperatures, fire or explosion). WARNING Only the smart rechargeable lithium-Ion battery can be installed in the external battery compartment. Ensure that compatible batteries are used for your monitor. For more information, see 26.3.1Identifying the Battery Type. Otherwise, the monitor may be damaged or cannot work properly. 26.3.1 Identifying the Battery Type The smart battery label the non-smart battery does not have it. is used to distinguish the battery type. The smart battery has this label, while Not all the battery types are applicable for your monitor. You can only use a smart battery if the smart battery label is available on the back of the battery compartment and a non-smart battery if the smart battery label is not available. The following figure shows the smart battery label on the back of the battery compartment 26.3.2 Installing the Battery in a Built-in Battery Compartment No battery is installed when the monitor leaves the factory. The battery must only be installed by service personnel trained and authorized by Mindray. To install the battery, contact your service personnel. To install the battery, follow this procedure:
1. 2. Turn off the monitor. Disconnect the power cable and other cables. Open the battery door as indicated below. 3. Turn the latch aside. 26 - 2 4. 5. 6. Insert the battery into the battery compartment with the battery terminal inwards. For ePM 15M, you can insert a second battery into the other battery compartment. You can also insert a second battery into the other battery compartment. Turn the latch back to the middle position. Close the battery door. 26.3.3 Installing the Battery in a External Battery Compartment For ePM 12M, besides the built-in battery compartment, you can also use a smart battery by connecting an external battery compartment. The external battery compartment must only be installed by service personnel trained and authorized by Mindray. To install the battery, contact your service personnel. To install the smart battery into the external battery compartment, follow this procedure:
1. 2. 3. Turn off the monitor. Disconnect the power cable and other cables. Place the monitor on the worktable with monitor face down. Pull up the battery door to open the battery compartment as indicated below. 4. 5. Insert the battery into the battery compartment. Push the battery downwards till the battery terminal is plugged into the battery connector. Close the battery door. 26.4 Battery Indications The battery LED, on-screen battery power indicator and related alarm messages indicate the battery status. 26.4.1 Battery LED The battery LED indications are as follows:
Green: the battery is fully charged. Yellow: the battery is being charged. Green and flashing: the monitor is running on battery power. Off: no battery is installed, or the battery malfunctioned, or the AC mains is not connected when the monitor is powered off. 26.4.2 Battery Power Indicators The on-screen power indicator indicates the battery status as follows:
indicates that the battery is working correctly. The green portion represents the remaining charge. indicates that the battery power is low and needs to be charged. indicates that the battery is almost depleted and needs to be charged immediately. Otherwise, the monitor will automatically shut down soon. indicates that the battery is being charged. 26 - 3 indicates that no battery is installed or the battery has failed. 26.4.3 Battery-related Alarms When the battery level is low, the monitor presents the Low Battery alarm, the alarm lamp flashes, and the monitor produces an alarm sound. If the battery is almost depleted, the monitor presents the Critically Low Battery alarm. In this case, immediately connect the AC mains to power the monitor and charge the battery. Otherwise, the monitor will automatically shut down soon. For more information on battery-related alarms, see DAlarm Messages. 26.4.4 Checking the Battery Information To check the battery information, follow this procedure:
1. 2. Select the Main Menu quick key from the System column select Maintenance input the required password select Ok. Select the Battery Information tab. 26.5 Charging the Battery The battery is recharged automatically when the monitor is connected to AC mains power. 26.6 Maintaining the Battery 26.6.1 Conditioning the Battery The performance of batteries deteriorates over time. You should condition the batteries periodically or when you notice a degradation in performance.If the battery is not conditioned for a prolonged time, its charge indication may not be accurate and you may wrongly evaluate the remaining battery runtime. To condition a battery, follow this procedure:
1. 2. 3. 4. Disconnect the monitor from the patient and stop all monitoring and measuring procedures. Allow the battery to be charged uninterruptedly till it is fully charged. Allow the monitor to run on the battery until the battery is completely depleted and the monitor automat-
ically shuts down. Fully charge the battery again for use or charge it to 40 - 60% for storage. NOTE Do not use the monitor to monitor a patient during battery conditioning. Interrupting battery conditioning to use the monitor will prevent completion of the conditioning cycle and require repeating the conditioning process completely to properly condition the battery. 26.6.2 Checking Battery Performance The performance of a rechargeable battery deteriorates over time. You should check the battery performance periodically or if you are concerned that the battery may fail. See steps 1 to 3 of 26.6.1Conditioning the Battery to check battery performance. The operating time of the batteries reflects their performance directly. If the operating time of a battery is noticeably shorter than that stated in the specifications, the battery may have reached its service life or be malfunctioning. If the battery performance meets the requirement, fully charge the battery again for use or charge it to 40 - 60% for storage. NOTE Battery operating time depends on equipment configuration and operation. For example, high display brightness or measuring NIBP repeatedly will shorten the battery operating time. 26 - 4 26.7 Storing Batteries When storing batteries, make sure that the battery terminals do not come into contact with metallic objects. If batteries are stored for an extended period of time, place the batteries in a cool place with a partial charge of 40% to 60% capacity. Condition the stored batteries every three months. For more information, see 26.6.1Conditioning the Battery. NOTE Remove the battery from equipment if the equipment is not used for a prolonged time (for example, several weeks). Otherwise the battery may overdischarge. Storing batteries at high temperature for an extended period of time will significantly shorten their life expectancy. The battery storage temperature is between -5 C and 35 C. Storing batteries in a cool place can slow the aging process. Ideally the batteries should be stored at 15 C. 26.8 Recycling Batteries Discard a battery in the following situations:
The battery has visual signs of damage. The battery fails. The battery is aged and its runtime significantly less than the specification. The battery service life is reached. Properly dispose of batteries according to local regulations. WARNING Do not open batteries, heat batteries above 60 C, incinerate batteries, or short the battery terminals. They may ignite, explode, leak or heat up, causing personal injury. 26 - 5 27 Care and Cleaning 27.1 Care and Cleaning Introduction In this chapter we only describe cleaning and disinfection of the main unit, modules and certain accessories. For the cleaning and disinfection of other reusable accessories, refer to their instructions for use of the corresponding accessories. Keep your equipment and accessories clean. To avoid damage to the equipment, follow these guidelines:
Always follow the manufacturers instructions for each cleaning / disinfecting agent. Do not immerse any part of the equipment or accessories into liquid. Do not pour liquid onto the equipment or accessories. Do not allow liquid to enter the case. Never use abrasive materials (such as steel wool or silver polish), or erosive cleaners (such as acetone or acetone-based cleaners). 27.2 Care and Cleaning Safety Information WARNING Be sure to turn off the system and disconnect all power cables from the outlets before cleaning the equipment. CAUTION If you spill liquid on the equipment or accessories, contact Mindray or your service personnel. Avoid wetting the pins and metal parts of the equipment, mounting kits or accessories during Use only Mindray approved cleaners and disinfectants and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by unapproved substances or methods. cleaning and disinfection. We make no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. For the method to control infection, consult your hospitals Infection Control Officer or Epidemiologist. The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter. Refer to the respective instructions for use of the cleaning agents and disinfectants. Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result. NOTE To clean or disinfect reusable accessories, refer to the instructions delivered with the accessories. 27 - 1 27.3 Cleaning and Disinfecting the Equipment and Mounting Kits Use approved cleaning and disinfecting agents for cleaning or disinfecting the main unit and modules. 27.3.1 Approved Cleaning and Disinfecting Agents The following table lists approved cleaning and disinfecting agents:
Product Name Product Type Active Ingredients Sodium hypochlorite bleach Liquid Sodium hypochlorite bleach 0.5%
Hydrogen peroxide Isopropanol 1-Propanol Metrex CaviCide1 Virex II 256 (1:256) Virex TB Rely+OnTM Virkon High Level Surface Disinfectant Powder Alpet D2 Surface Sanitizing Wipes Wipes Clorox Dispatch Hospital Cleaner Disinfectant Towels with Bleach Clorox Healthcare Bleach Germicidal Wipes Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes Diversey Oxivir TB Wipes Metrex CaviWipes PDI Sani-Cloth AF3 Germicidal Disposable Wipe PDI Sani-Cloth Bleach Germicidal Disposable Wipe PDI Sani-Cloth HB Germicidal Disposable Wipe Hydrogen peroxide 3%
Isopropanol 70%
1-Propanol 50%
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%, Isopropanol 17.2%
Didecyl dimethyl ammonium chloride 8.704%, n-Alkydimethyl benzyl ammonium chloride 8.190%
n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%
Used as 1% solution Biocidal active:
Pentapotassium bis (peroxymonosulphate) bis
(sulphate)(500g/kg), Contains dipotassium peroxodisulphate. Isopropyl Alcohol 58.6000%, Octyl Decyl Dimethyl Ammonium chloride 0.0075%, Dioctyl Dimethyl Ammonium Chloride 0.0030%
Sodium Hypochlorite 0.65%
Sodium Hypochlorite 0.55%
Hydrogen Peroxide 1.4%
Hydrogen Peroxide 0.5%
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%, Isopropanol 17.2%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.14%, n-Alkyl dimethyl benzyl ammonium chlorides 0.14%
Sodium Hypochlorite 0.63%,other ingredients 99.37%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.07%, n-Alkyl dimethyl benzyl ammonium chlorides 0.07%
27 - 2 Product Name Product Type Active Ingredients PDI Sani-Cloth Plus Germicidal Disposable Cloth Wipes PDI Super Sani-Cloth Germicidal Disposable Wipe n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.125%, n-Alky dimethyl benzyl ammonium chlorides 0.125%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%, Isopropyl Alcohol 55.0%
VIRAGUARD Hospital Surface Disinfectant Towelettle Isopropanol 70%, Other ingredients 30%
: NOTE For equipment with the symbol use.
, all the listed cleaning and disinfecting agents are available for 27.3.2 Cleaning the Equipment and Mounting Kits The main unit and modules should be cleaned on a regular basis. Before cleaning the equipment, consult your hospitals regulations for cleaning the equipment. To clean your equipment, follow this procedure:
1. 2. 3. Shut down the monitor and disconnect it from the AC power. Clean the display screen with wipes or a soft cloth moistened with one of the cleaning agents listed in 27.3.1Approved Cleaning and Disinfecting Agents only. Clean the exterior surface of the equipment or module with wipes or a soft cloth moistened with one of the cleaning agents listed in 27.3.1Approved Cleaning and Disinfecting Agents only. 4. Wipe off all the cleaning agent residue with a dry cloth. 5. Dry your equipment in a ventilated, cool place. 27.3.3 Disinfecting the Equipment and Mounting Kits Disinfect the main unit and modules as required in your hospitals servicing schedule using the disinfecting agents listed in the table above. Cleaning equipment before disinfecting is recommended. CAUTION Never use EtO or formaldehyde for disinfection. 27.4 Cleaning and Disinfecting the Accessories For the NIBP air hose, Masimo SpO2 cable and Nellcor SpO2 cable, you should clean and disinfect them using the cleaners and disinfectants and methods listed in this section. For other accessories, you should consult the instructions delivered with the accessories. CAUTION Fluids entering the NIBP air hose can damage the equipment. When cleaning and/or disinfecting the NIBP air hose, prevent liquid from entering the hose. Periodically inspect the NIBP air hose and connector for signs of wear or deterioration. Replace the NIBP air hose if you detect a leak. Dispose of damaged NIBP air hose according to local laws for disposal of hospital waste. Never immerse or soak the accessories in any liquid. Never clean or disinfect the metalic connectors at either end of the accessories. 27 - 3 Use only Mindray approved cleaners and disinfectants and methods listed in this section to clean or disinfect the accessories. Warranty does not cover damage caused by unapproved substances or methods. To avoid long term damage, the accessories should be disinfected only when necessary as determined by your hospitals policy. 27.4.1 Approved Accessories Cleaning and Disinfecting Agents The following table lists approved NIBP air hose cleaning and disinfecting agents:
:
Product Name Isopropanol 1-Propanol Metrex CaviCide1 Virex TB Product Type Active Ingredients Liquid Isopropanol 70%
1-Propanol 50%
Rely+OnTM Virkon High Level Surface Disinfectant Powder Alpet D2 Surface Sanitizing Wipes Wipes Clorox Dispatch Hospital Cleaner Disinfectant Towels with Bleach Metrex CaviWipes PDI Sani-Cloth AF3 Germicidal Disposable Wipe PDI Sani-Cloth Plus Germicidal Disposable Cloth PDI Super Sani-Cloth Germicidal Disposable Wipe Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%, Isopropanol 17.2%
n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%
Used as 1% solution Biocidal active:
Pentapotassium bis (peroxymonosulphate) bis
(sulphate)(500g/kg), Contains dipotassium peroxodisulphate. Isopropyl Alcohol 58.6000%, Octyl Decyl Dimethyl Ammonium chloride 0.0075%, Dioctyl Dimethyl Ammonium Chloride 0.0030%
Sodium Hypochlorite 0.65%
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride 0.28%, Isopropanol 17.2%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.14%, n-Alkyl dimethyl benzyl ammonium chlorides 0.14%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.125%, n-Alky dimethyl benzyl ammonium chlorides 0.125%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%, Isopropyl Alcohol 55.0%
VIRAGUARD Hospital Surface Disinfectant Towelettle Isopropanol 70%, Other ingredients 30%
27 - 4 The following table lists approved Masimo SpO2 cable cleaning and disinfecting agents:
:
Product Name Isopropanol Product Type Active Ingredients Liquid Isopropanol 70%
The following table lists approved Nellcor SpO2 cable cleaning and disinfecting agents:
:
Product Name Product Type Active Ingredients Sodium hypochlorite bleach Liquid Sodium hypochlorite bleach 0.5%
Isopropanol 1-Propanol Virex TB Rely+OnTM Virkon High Level Surface Disinfectant Powder Isopropanol 70%
1-Propanol 50%
n-Alkyl dimethyl benzyl ammonium chlorides 0.105%, n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.105%
Used as 1% solution Biocidal active:
Pentapotassium bis (peroxymonosulphate) bis
(sulphate)(500g/kg), Contains dipotassium peroxodisulphate. Clorox Dispatch Hospital Cleaner Disinfectant Towels with Bleach Clorox Healthcare Bleach Germicidal Wipes Clorox Healthcare Hydrogen Peroxide Cleaner Disinfectant Wipes Diversey Oxivir TB Wipes PDI Super Sani-Cloth Germicidal Disposable Wipe Wipes Sodium Hypochlorite 0.65%
Sodium Hypochlorite 0.55%
Hydrogen Peroxide 1.4%
Hydrogen Peroxide 0.5%
n-Alkyl dimethyl ethylbenzyl ammonium chlorides 0.25%, n-Alkyl dimethyl benzyl ammonium chlorides 0.25%, Isopropyl Alcohol 55.0%
VIRAGUARD Hospital Surface Disinfectant Towelettle Isopropanol 70%, Other ingredients 30%
27.4.2 Cleaning the Accessories You should clean the accessories (NIBP air hose, Masimo SpO2 cable and Nellcor SpO2 cable) on a regular basis. Before cleaning the accessories, consult your hospitals regulations for cleaning the accessories. To clean the accessories (NIBP air hose, Masimo SpO2 cable and Nellcor SpO2 cable), follow this procedure:
Clean the accessories with wipes or a soft cloth moistened with one of the cleaning agents listed in 1. 27.4.1Approved Accessories Cleaning and Disinfecting Agents only. 2. Wipe off all the cleaning agent residue with a dry cloth. 3. Allow the accessories to air dry. 27.4.3 Disinfecting the Accessories We recommend that the accessories (NIBP air hose, Masimo SpO2 cable and Nellcor SpO2 cable) should be disinfected only when necessary as determined by your hospitals policy, to avoid long term damage to the accessories. Cleaning the accessories before disinfecting is recommended. 27 - 5 27.5 Sterilization Sterilization is not recommended for this equipment, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the products, accessories or supplies. 27 - 6 28 Maintenance 28.1 Maintenance Introduction Regular maintenance is essential to ensure that the equipment continues to function properly. This chapter contains information on periodic testing and maintenance. 28.2 Maintenance Safety Information WARNING To avoid electric shock, stop using the equipment if you find the housing is damaged, and contact the service personnel. Failure on the part of the responsible individual hospital or institution using this equipment to implement a recommended maintenance schedule may cause undue equipment failure and possible health hazards. No modification of this equipment is allowed. This equipment contains no user serviceable parts. The safety checks or maintenance involving any disassembly of the equipment should be performed by professional service personnel. Otherwise, undue equipment failure and possible health hazards could result. Do not open batteries, heat batteries to above 60 C, incinerate batteries, or short the battery terminals. Batteries may ignite, explode, leak or heat up, causing personal injury. The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment. CAUTION The equipment and accessories shall not be serviced or maintained while in use on a patient. If you discover a problem with any of the equipment, contact your service personnel or Mindray. Use and store the equipment within the specified temperature, humidity, and altitude ranges. When disposing of the packaging material, be sure to observe the applicable waste control At the end of its service life, the equipment, as well as its accessories, must be disposed of in regulations and keep it out of the reach of children. compliance with the guidelines regulating the disposal of such products. If you have any questions concerning disposal of the equipment, please contact Mindray. 28 - 1 28.3 Maintenance and Testing Schedule Follow the maintenance and testing schedule or local regulations to perform testing and maintenance such as defined in section 28.5Testing Methods and Procedures. Follow your hospital policy on cleaning and disinfecting the equipment before testing and maintenance. The following table lists the maintenance and testing schedule:
Test/Maintenance Item Recommended Frequency Performance Tests Visual inspection Measurement module performance test and calibration Analog output test Defibrillation synchronization test Nurse call test Electrical Safety Tests Electrical safety tests Other Tests Power-on test Recorder check Network printer tests Device integration check Every day, before first use. 1. If you suspect that the measurement values are incorrect. 2. Follow any repairs or replacement of relevant module. 3. Once a year for CO2 and AG tests. 4. Once every two years for other parameter module performance tests. If you suspect that the analog output function does not work properly. If you suspect that the defibrillation synchronization function does not work properly. If you suspect that the nurse call function does not work properly. Once every two years. Before use 1. When the recorder is used for the first time. 2.Follow any repair or replacement of the recorder. 1. When first installed. 2.Followany repair or replacement of the printer. 1. When first installed. 2. Following any repair or replacement of the external device. Battery check Functionality test 1. When first installed. 2. When battery is replaced. Performance test Every three months or if the battery runtime is reduced significantly. 28.4 Checking System Software Version To view system software version information, select the Main Menu quick key from the System column select Version. You can check the detailed system software version, module hardware and software version, and firmware version only from the Maintenance dialog. 28.5 Testing Methods and Procedures Except for the following maintenance tasks, all other test and maintenance tasks should be performed by Mindray-qualified service personnel only. Regular checks, including visual inspection and power-on test Printer and recorder tests Battery check 28 - 2 If your monitor needs a safety test and performance test, contact the service personnel. 28.5.1 Performing Visual Inspection Visually inspect the equipment before its first use every day. If you find any signs of damage, remove your monitor from use and contact the service personnel. Verify that the equipment meets the following requirements:
Environment and power supply specifications are met. The monitor housing and display screen are free from cracks or other damage. The power cord is not damaged and the insulation is in good condition. Connectors, plugs, and cables are not damaged or kinked. Power cord and patient cables are securely connected with the equipment and modules. 28.5.2 Performing Power-on Test The monitor automatically performs a power-on test at startup. Verify the following items for the power-on test:
The equipment powers on properly. The alarm system works properly, denoted by alarm sounds and display of all 3 alarm light colors. The monitor displays properly. 28.5.3 Testing the Recorder To test the recorder, follow this procedure:
1. 2. 3. Start a recording task to print waveforms and reports. Check that the recorder functions correctly. Check that the printout is clear without missing dots. 28.5.4 Testing the Network Printer To check the printer, follow this procedure:
1. 2. 3. Start a printing task to print waveforms and reports. Check that the printer is properly connected and functions correctly. Check that the printout is clear without missing information. 28.5.5 Checking the Battery For information on battery check, see 26.6.2Checking Battery Performance. 28.6 NIBP Maintenance 28.6.1 NIBP Leakage Test The NIBP leakage test checks the integrity of the system and of the valve. The NIBP leakage test should be performed once every two years or when you doubt the NIBP measurements. The NIBP leakage test should be performed by Mindray-qualified service personnel only. 28.6.2 NIBP Accuracy Test The NIBP accuracy test should be performed once every two years or when you doubt the NIBP measurements. The NIBP accuracy test should be performed by Mindray-qualified service personnel only. 28 - 3 28.7 Disposing of the Monitor Dispose of the monitor and its accessories when its service life is reached. Follow local regulations regarding the disposal of such product. WARNING For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste. 28 - 4 29 Accessories The accessories listed in this chapter comply with the requirements of IEC 60601-1-2 when in use with the patient monitor. The accessory material that contacts the patients has undertaken the bio-compatibility test and is verified to be in compliance with ISO 10993-1. For details about the accessories, refer to the instructions for use provided with the accessory. WARNING Use accessories specified in this chapter. Using other accessories may cause damage to the patient monitor or not meet the claimed specifications. Single-use accessories are not designed to be reused. Reuse may cause a risk of contamination and affect the measurement accuracy. CAUTION The accessories may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If accessory performance is degraded due to aging or environmental conditions, contact your service personnel. Check the accessories and their packages for any sign of damage. Do not use them if any damage is Use the accessories before the expiration date if an expiration date is indicated. Discard disposable accessories according to hospital regulations. detected. NOTE This manual describes all the accessories that are validated for use. Not all accessories are available in every market. 29.1 ECG Accessories 29.1.1 ECG Electrodes Available for Purchase Model 31499224 2245-50 Part No. Description Usage Applicable patient 0010-10-12304 Electrode, Kendall, pkg of 10 Disposable Adult 9000-10-07469 ECG electrode, 3M, pkg of 50 Disposable Pediatric 1050NPSMKittycat 0681-00-0098-01 1051NPSMKittycat 0681-00-0098-02 H124SG 900E-10-04880 NEO pre-wired electrode radio Opaque, pkg of 100 NEO pre-wired electrode radio Translucent, pkg of 100 Neonatal ECG electrode (kendall, package of 50) Disposable Neonate Disposable Neonate Disposable Neonate 29 - 1 29.1.2 12-Pin Trunk Cables Available for Purchase Model EV6206 EV6207 EV6216 EV6217 EV6208 Part No. Description Usage Applicable patient 009-005266-00 009-005267-00 009-005268-00 009-005269-00 040-003528-00 ECG cable, 10' (3.1 m), defibrillation-
proof, for N/T ECG cable, 20' (6.2 m), defibrillation-
proof, for N/T ECG cable, 10' (3.1 m), ESU-proof, for N/T ECG cable, 20' (6.2 m), ESU-Proof, for N/T ECG cable, 10' (3.1 m), 12-lead, defibrillation-proof, for N/T 5-lead leadwires Reusable Adult/Pediatric Reusable Adult/Pediatric Reusable Adult/Pediatric Reusable Adult/Pediatric Reusable Adult/Pediatric Note: 040-003528-00 uses 5-Lead N/T leadwires for the limb leads. 29.1.3 12-Pin Trunk Cables Also Compatible Model EV6201 EV6202 EV6203 EV6211 EV6212 EV6222 Part No. Description Usage Applicable patient 0010-30-42719 0010-30-42720 0010-30-42721 0010-30-42723 0010-30-42724 040-000754-00 12Pin 3/5-Lead ECG trunk cable, defibrillation-proof 12Pin 3-Lead ECG trunk cable, defibrillation-proof 12Pin 12-Lead trunk cable, defibrillation-proof 12Pin 3/5-Lead ECG trunk cable, ESU-
proof 12Pin 3-Lead ECG trunk cable, ESU-
proof 12Pin 3-Lead trunk cable, defibrillation-proof, DIN Conn Reusable Adult/Pediatric Reusable Pediatric/Neonate Reusable Adult/Pediatric Reusable Adult/Pediatric Reusable Pediatric/Neonate Reusable Pediatric/Neonate 29.1.4 3-lead ECG Leadwires Available for Purchase Model EY6316B EY6305B EY6316A EY6305A EY6310B Part No. Description Usage Applicable patient 009-004765-00 3-Lead, N/T, AHA, snap, 24 Reusable Adult/Pediatric 009-004766-00 3-Lead, N/T, AHA, snap, 36 Reusable Adult/Pediatric 009-004771-00 3-Lead, N/T, AHA, clip, 24 Reusable Adult/Pediatric 009-004772-00 3-Lead, N/T, AHA, clip, 36 Reusable Adult/Pediatric 009-004777-00 3-Lead, N/T, AHA, snap, 24 Disposable Adult/Pediatric 29.1.5 3-lead ECG Leadwires Also Compatible Model EL6305A EL6303A Part No. Description Usage Applicable patient 0010-30-42896 3-Lead leadset, AHA, clip Reusable Neonate 0010-30-42731 3-Lead leadset, AHA, clip, Long Reusable Adult/Pediatric 29 - 2 Model EL6301B EL6311B EL6311A Part No. Description Usage Applicable patient 0010-30-42734 3-Lead leadset, AHA, snap Reusable Adult/Pediatric 040-000146-00 3-Lead leadset, AHA, snap Disposable Pediatric/Neonate 040-000148-00 3-Lead leadset, AHA, clip Disposable Pediatric/Neonate 29.1.6 5-lead ECG Leadwires Available for Purchase Model EY6511B EY6512B EY6511A EY6512A EY6507B Part No. Description Usage Applicable patient 009-004782-00 5-Lead, N/T, AHA, snap, 24 Reusable Adult/Pediatric 009-004783-00 5-Lead, N/T, AHA, snap, 36 Reusable Adult/Pediatric 009-004786-00 5-Lead, N/T, AHA, pinch, 24 Reusable Adult/Pediatric 009-004787-00 5-Lead, N/T, AHA, pinch, 36 Reusable Adult/Pediatric 009-004790-00 5-Lead, N/T, AHA, snap, 24 Disposable Adult/Pediatric 29.1.7 5-lead ECG Leadwires Also Compatible Model EL6503A EL6501B EL6501A Part No. Description Usage Applicable patient 0010-30-42729 5-Lead leadset, AHA, clip, Long Reusable Adult/Pediatric 0010-30-42735 5-Lead leadset, AHA, snap Reusable Adult/Pediatric 0010-30-42727 5-Lead leadset, AHA, clip Reusable Adult/Pediatric 29.1.8 6-lead ECG Leadwires Available for Purchase Model EY6601B EY6602B EY6601A EY6602A Part No. Description Usage Applicable patient 009-004794-00 6-Lead, N/T, AHA, snap, 24 Reusable Adult/Pediatric 009-004795-00 6-Lead, N/T, AHA, snap, 36 Reusable Adult/Pediatric 009-004798-00 6-Lead, N/T, AHA, pinch, 24 Reusable Adult/Pediatric 009-004799-00 6-Lead, N/T, AHA, pinch, 36 Reusable Adult/Pediatric 29.1.9 12-lead ECG Chest Leadwires Available for Purchase Model EL6803A EL6803B Part No. Description Usage Applicable patient 0010-30-42904 12-Lead leadset, chest, AHA, clip Reusable Adult/Pediatric 0010-30-42908 12-Lead leadset, chest, AHA, snap Reusable Adult/Pediatric 29.1.10 12-lead ECG Leadwires Also Compatible Model EL6801A EL6801B Part No. Description Usage Applicable patient 0010-30-42902 12-Lead leadset, limb, AHA, clip Reusable Adult/Pediatric 0010-30-42906 12-Lead leadset, limb, AHA, snap Reusable Adult/Pediatric 29 - 3 29.2 SpO2 Accessories Wavelength emitted by the sensors is between 600 nm and 1000 nm. The maximum photic output consumption of the sensor is less than 18 mW. The information about the wavelength range and maximum photic output consumption can be especially useful to clinicians, for example, when photodynamic therapy is performed. 29.2.1 Extension Cables and Adapter Cables Available for Purchase Model Part No. Description Usage Applicable patient 572A 583A 4089 4092 0010-20-42712 8-pin SpO2 extension cable, Nellcor Reusable 040-003310-00 8-pin, RD SET, Masimo Reusable 040-003381-00 RD to LNCS adapter cable, Masimo Reusable 040-003426-00 LNCS to RD adapter, Masimo Reusable
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/
29.2.2 Extension Cables and Adapter Cables Also Compatible Model Part No. Description Usage Applicable patient 582A 562A 562B 4080 4081 115-020768-00 8-pin SpO2 extension cable, Masimo Reusable 0010-20-42710 7pin SpO2 Cable 040-001443-00 7Pin Mindray SpO2 cable, 1.2m 040-003378-00 RD SET MD 14-05, PC 5 ft Reusable Reusable Reusable 040-003379-00 RD SET MD 14-12, Patient Cable 12 ft Reusable
/
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29.2.3 Masimo SpO2 RD Set Sensors Available for Purchase Model Part No. Description Usage Applicable patient 4050 4051 4053 4000 4001 4002 4003 4004 4005 040-003376-00 SpO2 sensor, RD SET DCI Reusable Adult (> 30 kg) 040-003377-00 SpO2 sensor, RD SET DCI Reusable Pediatric (10-50 kg) 040-003380-00 040-003382-00 040-003383-00 040-003384-00 040-003385-00 040-003386-00 040-003387-00 SpO2 sensor, RD Set TC-I, tip-clip ear sensor, 3ft SpO2 sensor, RD SET Adt, adhesive, pkg of 20 Reusable Adult (> 30 kg) Disposable Adult (> 30 kg) SpO2 sensor, RD SET PDT, adhesive, pkg of 20 Disposable Pediatric (10 to 50 kg) SpO2 sensor, RD Set Inf, adhesive, pkg of 20 Disposable Infant (3 to 20 kg) SpO2 sensor, RD Set Neo, adhesive, pkg of 20 Disposable Neonatal /Adult
(<3Kg or >40Kg) SpO2 sensor, RD Set NeoPt, adhesive, pkg of 20 SpO2 sensor, RD Set NeoPt-500, non-
adhesive, pkg of 20 Disposable Neonate (<1 kg) Disposable Neonate (<1 kg) 29 - 4 29.2.4 Masimo SpO2 LNCS Sensors Also Compatible Model LNCS DCI LNCS DCIP LNCS YI Part No. Description Usage Applicable patient 0010-10-42600 SpO2 sensor, finger-clip Reusable Adult (>30 kg) 0010-10-42634 SpO2 sensor, finger-clip Reusable Pediatric (10-50 kg) 0010-10-43016 SpO2 sensor, multisite Reusable Adult/Pediatric/
Neonate LNCS NeoPt-L 0010-10-42626 SpO2 sensor Disposable Neonate (<1 kg) LNCS Neo-L 0010-10-42627 SpO2 sensor Disposable Neonate /Adult
(<3 kg or>40 kg) LNCS Inf-L LNCS Pdtx LNCS Adtx LNCS Adtx LNCS Pdtx LNCS DCI LNCS DCIP 0010-10-42628 SpO2 sensor Disposable Infant (3-20 kg) 0010-10-42629 SpO2 sensor Disposable Pediatric (10-50 kg) 0010-10-42630 SpO2 sensor Disposable Adult (>30 kg) 0600-00-0121 SpO2 sensor, finger-clip, 20 pcs/box Disposable Adult (>30 kg) 0600-00-0122 SpO2 sensor, finger-clip, 20 pcs/box Disposable Pediatric (10-50 kg) 0600-00-0126 SpO2 sensor, finger-clip Reusable Adult (>30 kg) 0600-00-0127 SpO2 sensor, finger-clip Reusable Pediatric (10-50 kg) LNCS NeoPt 0600-00-0156 SpO2 sensor, finger-clip Disposable Neonate (<1Kg) LNCS Neo-L 0600-00-0157 SpO2 sensor, 20 pcs/box Disposable Neonate /Adult
(<3 kg or > 40 kg) LNCS Inf 0600-00-0158 SpO2 sensor, 20 pcs/box Disposable Infant (3-20 kg) 29.2.5 Nellcor SpO2 Sensors Also Compatible Model DS100A D-YS OXI-P/I OXI-A/N MAXAI MAXPI MAXII MAXNI Part No. Description Usage Applicable patient 9000-10-05161 SpO2 sensor, finger-clip Reusable Adult 0010-10-12476 SpO2 sensor, with wraps Reusable
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9000-10-07308 SpO2 sensor, finger, band Reusable Pediatric/Infant 9000-10-07336 SpO2 sensor, finger/foot, band Reusable Adult/Neonate 0010-10-12202 SpO2 sensor, 24 pcs/box Disposable Adult (>30 kg) 0010-10-12203 SpO2 sensor, 24 pcs/box Disposable Pediatric (10-50 Kg) 0010-10-12204 SpO2 sensor, 24 pcs/box Disposable Infant (3-20 kg) 0010-10-12205 SpO2 sensor, 24 pcs/box Disposable Adult/Neonate
(<3 kg or >40 kg) 29.2.6 Mindray SpO2 Sensors Model 512F 512FLH 512H 512E Part No. Description Usage Applicable patient 512F-30-28263 SpO2 sensor, finger-clip 115-012807-00 SpO2 sensor, finger-clip,7pin 512H-30-79061 SpO2 sensor, finger-clip 512E-30-90390 SpO2 sensor, finger-tip Reusable Reusable Reusable Reusable Adult Adult Pediatric Adult 29 - 5 Model Part No. Description Usage Applicable patient 512G 518B 518C 520A 520P 520I 520N
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512G-30-90607 SpO2 sensor, finger-tip 518B-30-72107 SpO2 sensor, foot, bandage 040-000330-00 SpO2 sensor, foot, bandage Reusable Reusable Reusable Pediatric Neonate Neonate 009-005087-00 SpO2 sensor, finger, non-adhesive Disposable Adult 009-005088-00 SpO2 sensor, finger, non-adhesive Disposable Pediatric 009-005089-00 SpO2 sensor, toe, non-adhesive Disposable Infant 009-005090-00 SpO2 sensor, foot, non-adhesive Disposable Neonate 115-004895-00 Reusable SpO2 Sensor, Neo, Bandage Disposable Neonate 29.3 Temp Accessories 29.3.1 Temp Cable Available for Purchase Model MR420B Part No. Description Usage Applicable patient 040-001235-00 2-pin Temperature adapter cable Reusable
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29.3.2 Temp Probes Available for Purchase Model MR401B MR402B MR403B MR404B MR411 MR411 MR412 MR412
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Part No. Description Usage Applicable patient 0011-30-37392 Temperature probe, endocavity Reusable Adult 0011-30-37394 Temperature probe, endocavity Reusable Pediatric/Infant 0011-30-37393 Temperature probe, skin surface Reusable Adult 0011-30-37395 Temperature probe, skin surface Reusable Pediatric/Infant 040-003292-00 040-003294-00 Temperature probe, esophageal/
rectal, 9FR Temperature probe, esophageal/
rectal, 9FR, pkg of 20 Disposable Adult/Pediatric Disposable Adult/Pediatric 040-003293-00 Temp probe, skin surface Disposable 040-003295-00 Temp probe, skin surface, pkg of 20 Disposable 0206-03-0112-02 PROBE,D TEMP,ES400-12 (box of 20) Disposable 0206-03-0118-02 PROBE,D TEMP,ES400-18 (box of 20) Disposable 0206-03-0209-02 PROBE,D TEMP,ER 400-9 (box of 20) Disposable 0206-03-0212-02 PROBE,D TEMP,ER400-12 (box of 20) Disposable 0206-03-0300-02 PROBE,D TEMP,STS-400 (box of 20) Disposable All All Adult Adult Adult Adult Adult 29 - 6 29.4 NIBP Accessories 29.4.1 NIBP Hoses Available for Purchase Model CM1903 CM1901 Part No. Description Usage Applicable patient 6200-30-09688 NIBP hose, inbuilt connector, 3m Reusable Adult/Pediatric 6200-30-11560 NIBP hose, inbuilt connector, 3m Reusable Neonate 29.4.2 Cuffs Available for Purchase Model CM1200 CM1201 CM1202 CM1203 CM1204 CM1205 CM1301 CM1302 CM1303 CM1304 CM1305 CM1306 CM1307 CM1501 CM1502 CM1503 CM1504 CM1505 CM1506 CM1507 CM1500A CM1500B CM1500C CM1500D CM1500E Part No. Description Usage Applicable patient 115-002480-00 Cuff, 7-13 cm Reusable Small Infant 0010-30-12157 Cuff, 10-19 cm 0010-30-12158 Cuff, 18-26 cm 0010-30-12159 Cuff, 25-35 cm 0010-30-12160 Cuff, 33-47 cm Reusable Infant Reusable Pediatric Reusable Reusable Adult Adult 0010-30-12161 Cuff, 46-66 cm Reusable Adult thigh 115-027713-00 Cuff, 10-19 cm, bladderless Reusable Infant 115-027714-00 Cuff, 18-26 cm, bladderless Reusable Small Adult 115-027715-00 Cuff, 25-35 cm, bladderless 115-027716-00 Cuff, 33-47 cm, bladderless Reusable Reusable Adult Adult 115-027717-00 Cuff, 46-66 cm, bladderless Reusable Adult thigh 115-027718-00 Cuff, 24-35 cm, bladderless 115-027719-00 Cuff, 33-47 cm, bladderless Reusable Reusable 115-027556-00 Cuff, 10-19 cm, bladderless Disposable Adult Adult Child 115-027557-00 Cuff, 18-26 cm, bladderless Disposable Small adult 115-027558-00 Cuff, 25-35 cm, bladderless Disposable Adult 115-027559-00 Cuff, 33-47 cm, bladderless Disposable Large adult 115-027560-00 Cuff, 46-66 cm, bladderless Disposable Adult thigh 115-027561-00 Cuff, 25-35 cm, bladderless, long Disposable Adult 115-027562-00 Cuff, 33-47 cm, bladderless, long Disposable Large adult 001B-30-70677 Cuff, 3.1-5.7 cm 001B-30-70678 Cuff, 4.3-8.0 cm 001B-30-70679 Cuff, 5.8-10.9 cm 001B-30-70680 Cuff, 7.1-13.1 cm 001B-30-70681 Cuff, 5#
Disposable Neonate Disposable Neonate Disposable Neonate Disposable Neonate Disposable Neonate 29 - 7 29.5 IBP Accessories 29.5.1 IBP Accessories Available for Purchase Model IM2202 IM2201 IM2211 IM2204 Part No. Description Usage Applicable patient 001C-30-70757 12 Pin IBP cable, Argon 001C-30-70759 12 Pin IBP cable, ICU Medical 0010-21-12179 12 Pin IBP cable, Edwards 040-001029-00 IBP extended cable with dual-
receptacle Reusable Reusable Reusable Reusable
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29.5.2 IBP Accessories Also Compatible Part No. Description Usage Applicable patient 6000-10-02107 Disposable transducer kit, Argon Disposable 0010-10-12156 Mounting background and accessory for IBP transducer, Argon Reusable 0010-10-42638 IBP transducer, ICU Medical M90-000133---
M90-000134---
Mounting background and accessory for IBP transducer, ICU Medical Mounting clamp for IBP transducer
(send with the cable), ICU Medical Reusable Disposable Reusable 29.5.3 ICP Accessories Available for Purchase Model 82-6653 CP12601 CP12603
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Part No. Description Usage Applicable patient 040-002336-00 Codman ICP sensor kit, Johnson &
Johnson, pkg of 1 Disposable 009-005460-00 12 Pin ICP Cable 040-001368-00 Adapter for Camino cable 009-004401-00 ICP adapting cable for Camino Reusable Reusable Reusable
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29.6 C.O. Accessories Available for Purchase Part No. Description Usage Applicable patient 0010-30-42743 12Pin C.O. cable, Edwards 0012-00-1519 Cable, bath probe adapter 6000-10-02079 6000-10-02080 6000-10-02081 In-line injection temperature sensor, BD In-line injection temperature sensor housing, BD, pkg of 25 Disposable 12cc control syringe w/Rotator
(MEDEX MX387), pkg of 20 Disposable Reusable Reusable Reusable
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0012-00-1520 In-line inject temperature probe Reusable 29 - 8 Model DT-4812 682275 42584 42602 42394 Model CO7702
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SP4042 SP5045 MX387
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29.7 CO2 Accessories 29.7.1 Sidestream CO2 Accessories Available for Purchase Model Part No. Description Usage Applicable patient 4000 4100 4200 M02A-10-25937 CO2 Nasal sample cannula, 7' line Disposable Adult M02A-10-25938 CO2 Nasal sample cannula, 7' line Disposable Pediatric M02B-10-64509 CO2 Nasal sample cannula, 7' line Disposable Neonatal 60-15200-00 9200-10-10533 Sampling line, 2.5 m Disposable Adult/Pediatric 60-15300-00 9200-10-10555 Sampling line, 2.5 m Disposable Neonatal 60-14100-00 9000-10-07486 Dryline airway adapter, straight Disposable Adu/Ped 040-001187-00 040-001187-00 Airway Adapter Disposable Neonatal 60-14200-00 9000-10-07487 Dryline airway adapter, elbow Disposable
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100-000080-00 100-000080-00 Watertrap, DRYLINE II, pkg of 10 Reusable Adult/Pediatric 100-000081-00 100-000081-00 Watertrap, DRYLINE II, pkg of 10 Reusable Neonatal 29.7.2 Microstream CO2 Accessories Also Compatible Model XS04620 XS04624 006324 007768 007737 007738 009818 007266 009822 007269 009826 007743 008177 008178 008179 008180 008181 008174 008175 Part No. Description Usage Applicable patient 0010-10-42560 FilterLine Set Disposable Adult, pediatric 0010-10-42561 FilterLine H Set Disposable Adult, pediatric 0010-10-42562 FilterLine H Set Disposable Neonate 0010-10-42563 FilterLine Set, long Disposable Adult, pediatric 0010-10-42564 FilterLine H Set, long Disposable Adult, pediatric 0010-10-42565 FilterLine H Set, long Disposable Neonate 0010-10-42566 S CapnoLine Plus Disposable Adult 0010-10-42567 Smart CapnoLine Disposable Pediatric 0010-10-42568 S CapnoLine Plus O2 Disposable Adult 0010-10-42569 Smart CapnoLine O2 Disposable Pediatric 0010-10-42570 S CapnoLine Plus O2, long Disposable Adult 0010-10-42571 S CapnoLine O2, long Disposable Pediatric 0010-10-42572 CapnoLine H 0010-10-42573 CapnoLine H 0010-10-42574 CapnoLine H Disposable Adult Disposable Pediatric Disposable Neonate 0010-10-42575 CapnoLine H O2 Disposable Adult 0010-10-42576 CapnoLine H O2 Disposable Pediatric 0010-10-42577 NIV-Line 0010-10-42578 NIV-Line Disposable Adult Disposable Pediatric 29 - 9 29.7.3 Mainstream CO2 Accessories Model Part No. Description Usage Applicable patient 6063 6421 6312 7007 7053 9960LGE 9960STD 0010-10-42662 Airway adapter Disposable Adult, pediatric 0010-10-42663 Airway adapter, with mouthpiece Disposable Adult, pediatric 0010-10-42664 Airway adapter Disposable Pediatric, neonate 0010-10-42665 Airway adapter 0010-10-42666 Airway adapter Reusable Reusable 0010-10-42669 CAPNOSTAT CO2 large adult mask Disposable 0010-10-42670 CAPNOSTAT CO2 standard adult mask Disposable Adult, pediatric Neonate Adult Adult 9960PED 0010-10-42671 CAPNOSTAT CO2 pediatric mask Disposable Pediatric 6934 8751 0010-10-42667 Cable management straps (5 pcs) Reusable 0010-10-42668 Cable holding clips (5 pcs) Reusable Reusable
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1036698 6800-30-50760 CAPNOSTAT CO2 sensor 29.8 AG Accessories Model Part No. Description Usage Applicable patient 60-15200-00 9200-10-10533 Sampling line, 2.5 m Disposable Adult/Pediatric 60-15300-00 9200-10-10555 Sampling line, DRYLINE, 2.5m Disposable Neonate 60-14100-00 9000-10-07486 DRYLINE airway adapter, straight Disposable Adult/Pediatric 60-14200-00 9000-10-07487 DRYLINE airway adapter, elbow Disposable Adult/Pediatric 100-000080-00 100-000080-00 DRYLINE II water trap Reusable Adult/Pediatric 100-000081-00 100-000081-00 DRYLINE II water trap Reusable Neonate 60-13100-00 9200-10-10530 DRYLINE water trap Reusable Adult 60-13200-00 9200-10-10574 DRYLINE water trap Reusable Neonate 040-001187-00 040-001187-00 Airway adapter Reusable
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29.9 BeneLink Accessories Part No. 009-001767-00 009-001768-00 009-001769-00 009-002943-00 009-004613-00 009-008485-00 115-011465-00 115-007277-00 29 - 10 Description Serial port adapting cable, type A Serial port adapting cable, type B Serial port adapting cable, type C Serial port adapting cable, type D Serial port adapting cable, type E Serial port adapting cable, type F ID Adapter kit (contains ID Adapter with label and RJ45 cable with label) ID Adapter Part No. 047-004857-00 047-004859-00 009-001770-00 Description ID adapter label Network line label RJ45 connecting cable 29.10 External Modules Module C.O. module IBP module Part No. 115-047283-00 115-047286-00 Comments Supports C.O. monitoring Supports IBP monitoring Microstream CO2 module 6800-30-50820 Supports CO2 monitoring Sidestream CO2 module 115-049134-00 Supports CO2 monitoring, with adult and pediatric accessories Sidestream CO2 module 115-053711-00 Supports CO2 monitoring, with neonatal accessories Sidestream CO2/O2 module Sidestream CO2/O2 module 115-049136-00 115-053712-00 AG module 115-051561-00 Supports CO2 monitoring, integrates O2 (paramagnetic) monitoring, with adult and pediatric accessories Supports CO2 monitoring, integrates O2 (paramagnetic) monitoring, with neonatal accessories Supports AG monitoring, integrates O2 (paramagnetic) monitoring BeneLink module 115-053710-00 Connects external devices 29.11 Mount and Mounting Accessories Part No. 045-000915-00 045-000955-00 045-003425-00 045-003240-00 045-000924-00 045-000953-00 045-000931-00 045-002877-00 045-002936-00 8000-30-90170 045-003255-00 8000-30-90169 Description T5 rolling stand T5 trolley tray kit GCX VHM/M series arm adapter GCX M Series 12" arm with transition plate iPM/iMEC rolling stand iPM/iMEC trolley tray kit iPM/iMEC wall mount bracket VS600/VS900 new value stand No handle basket pack Bedrail clamp N12 roll stands (With iPM/iMEC adapter) Bedrail hook 29 - 11 29.12 Miscellaneous Accessories Part No. 009-001075-00 009-001791-00 009-002636-00 009-007190-00 009-007191-00 509B-10-05996 DA8K-10-14452 DA8K-10-14453 DA8K-10-14454 022-000179-00 022-000008-00 022-000248-00 023-000217-00 023-000218-00 023-001523-00 115-008393-00 023-001286-00 023-001288-00 023-001393-00 6800-30-51213 115-030320-00 009-003116-00 009-003117-00 009-003118-00 A30-000001---
009-003648-00 009-003903-00 Description Power cord, 250 V, 10 A, 3 m, Brazil Power cord, 250 V, 16 A, 3 m, South Africa Power cord, 10 A, 1.5 m, Australia standard Power cord, 3 m, India Power cord, 1.8 m, Switzerland Power cord, 10 A, 250 V, 1.6 m, China Power cord, USA Power cord, UK Power cord, Europe Lithium-ion battery, 10.95 V, 2600 mAh, LI13I001A Lithium-ion battery, 10.95 V, 4500 mAh, LI23S002A Smart Lithium-ion battery, 10.8 V, 5600 mAh, LI23I003A USB flash drive, 4 GB, USB2.0 USB flash drive, 8 GB, USB2.0 HP LaserJet Printer 1D Barcode reader 2D Barcode reader, HS-1M, JADAK 2D Barcode reader, HS-1R, JADAK Remote controller Beneview data output package Clinical Scoring Custom CD Nurse call cable Analog output cable Synchronization cable Recording paper, 50 mm*20 m Cable protecting tube, 20cm&40cm Accessories management tape 29 - 12 A Product Specifications A.1 Monitor Safety Specifications The monitor is classified, according to IEC 60601-1:
Degree of protection against electrical shock Type CF defibrillation proof for ECG, Resp, SpO2, NIBP, Temp, IBP, C.O. Type BF defibrillation proof for CO2, AG Type of protection against electrical shock Class I Degree of protection against harmful ingress of water IPX1 Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Mode of operation Continuous A.2 Physical Specifications Item Maximum Weight (kg) W H D (mm) Comments ePM 10M main unit ePM 12M main unit ePM 15M main unit 4.5(standard configuration and recorder, excluding battery, accessories and modules) 5.5(standard configuration and recorder, excluding battery, accessories and modules) 7.5(standard configuration and recorder, excluding battery, accessories and modules) 269 252 159 310 289 169 394 316 174 4.0 kg (standard configuration, excluding battery, accessories, modules and recorder) 4.8 kg (standard configuration, excluding battery, accessories, modules and recorder) 6.2 kg (standard configuration, excluding battery, accessories, modules and recorder) IBP module C.O. module Microstream CO2 module Sidestream CO2 module AG 0.26 0.25 0.38 0.63 1.03 136.5 40 102 136.5 40 102 136.5 40 102
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136.5 40 102 With build-in O2 module 136.5 80.5 102 With built-in O2 module A.3 Environmental Specifications WARNING The monitor may not meet the performance specifications if stored or used outside the specified temperature and humidity ranges. If the performance of the equipment is degraded due to aging or environmental conditions, contact your service personnel. 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. A - 1 NOTE The environmental specification of unspecified parameter modules are the same as those of the main unit. Main Unit Item Operating Condition Temperature (C) Relative humidity
(noncondensing) (%) Barometric 0 to 40
(0 to 35 configured with AG module) 15 to 95 427.5 to 805.5 mmHg
(57 to 107.4 kPa) 120 to 805.5 mmHg
(16 to 107.4 kPa) Storage Condition
-20 to 60 10 to 95 Microstream CO2 Module Item Temperature (C) Relative humidity
(noncondensing) (%) Barometric Operating Condition 0 to 40 Storage Condition
-20 to 60 15 to 95 10 to 95 430 to 790 mmHg
(57.3 to 105.3 kPa) 430 to 790 mmHg
(57.3 to 105.3 kPa) Sidestream CO2 Module Item Temperature (C) Relative humidity
(noncondensing) (%) Barometric Operating Condition 5 to 40 Storage Condition
-20 to 60 15 to 95 10 to 95 430 to 790 mmHg
(57.3 to 105.3 kPa) 430 to 790 mmHg
(57.3 to 105.3 kPa) Mainstream CO2 Module Item Temperature (C) Relative humidity
(noncondensing) (%) Barometric (mmHg) Operating Condition 0 to 40 Storage Condition
-20 to 60 10 to 90 10 to 90 430 to 790 mmHg
(57.3 to 105.3 kPa) 430 to 790 mmHg
(57.3 to 105.3 kPa) AG Module Item Temperature (C) Relative humidity
(noncondensing) (%) Barometric Operating Condition 10 to 40 Storage Condition
-20 to 60 15 to 95 10 to 95 525 to 805.5 mmHg
(70 to 107.4 kPa) 525 to 805.5 mmHg
(70 to 107.4 kPa) A - 2 A.4 Power Supply Specifications A.4.1 External Power Supply Specifications AC Power Input voltage Input current Frequency 100 to 240 VAC (10%) 2.0 to 0.9 A 50/60 Hz ( 3 Hz) A.4.2 Battery Specifications Battery LI13I001A Battery LI23S002A Battery LI23I003A Type Voltage Capacity Type Voltage Capacity Type Voltage Capacity Rechargeable lithium-Ion battery (non-smart battery) 10.95V 2600 mAh Rechargeable lithium-Ion battery (non-smart battery) 10.95V 4500 mAh Smart rechargeable lithium-Ion battery (smart battery) 10.8V 5600 mAh Maximum number of batteries configured ePM 10M:
only one battery can be connected. ePM 12M:
ePM 15M:
at most two batteries can be connected at the same time, including one battery built inside, the other one connected from an external battery compartment. at most two batteries can be connected at the same time. Run time Model ePM 12M/ePM 15M 2 hours ePM 10M 2 hours Battery LI13I001A
(one battery connected) Battery LI23S002A
(one battery connected) Battery LI23I003A
(one battery connected) Battery LI23I003A
(two batteries connected) 4 hours 4 hours 4.5 hours 6 hours 9 hours
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when the monitor is powered by a new fully-charged battery at 25 C5 C with 5-lead ECG and SpO2 cable connected, auto NIBP measurements at an interval of 15 minutes, and screen brightness set to 1. Shutdown delay: at least 15 minutes after the low battery alarm first occurs. A - 3 Charge time Battery LI13I001A
(one battery connected) Battery LI23S002A
(one battery connected) Battery LI23I003A
(one battery connected) Battery LI23I003A
(two batteries connected) No more than 2.5 hours to 90% when the monitor is off No more than 5 hours to 90% when the monitor is on No more than 5 hours to 90% when the monitor is off No more than 10 hours to 90% when the monitor is on No more than 5 hours to 90% when the monitor is off No more than 10 hours to 90% when the monitor is on No more than 10 hours to 90% when the monitor is off No more than 20 hours to 90% when the monitor is on A.5 Display Specifications Screen type Screen Size (diagonal) Resolution A.6 Recorder Specifications Method Horizontal resolution Vertical resolution Paper width Paper length Paper speed Capacitive, multi-point color touchscreen ePM 10M:
ePM 12M:
ePM 15M:
ePM 10M:
ePM 12M:
ePM 15M:
10.1 inches 12.1 inches 15.6 inches 1280 x 800 pixels 1280 x 800 pixels 1366 x 768 pixels Thermal dot array 16 dots/mm (25 mm/s paper speed) 8 dots/mm 50 mm1mm 20 m 25 mm/s, 50 mm/s Accuracy: 5%
Number of waveform channels A maximum of 3 A.7 LEDs Alarm lamp Power-on LED AC power LED Battery LED A - 4 1 or 2 (three color-coded: red, yellow, and cyan) 1 (green) 1 (green) 1 (two color-coded: yellow and green) A.8 Audio Indicator Speaker Give alarm tones (45 to 85 dB), reminder tones, key tones, QRS tones;
support PITCH TONE and multi-level tone modulation; alarm tones comply with IEC 60601-1-8. A.9 Monitor Interface Specifications AC power input Network connector USB connector Module rack Multifunctional connector 1 1, standard RJ45 connectors, 100 Base-TX, IEEE 802.3 2, USB 2.0 1 1 Video output connector 1, 15-pin D-sub Equipotential grounding terminal 1 A.10 Signal Outputs Specifications Auxiliary Output Standard ECG Analog Output Bandwidth
(-3dB; reference frequency: 10Hz) Meets the requirements of IEC 60601-1 for short-circuit protection and leakage current Diagnostic mode: 0.05 to 150 Hz Monitor mode: 0.5 to 40 Hz Surgical mode: 1 to 20 Hz ST mode: 0.05 to 40 Hz Maximum QRS delay 25 ms (in diagnostic mode, and non-paced) Gain (reference frequency 10Hz) 1V/mV (5%) Pace enhancement IBP Analog Output Bandwidth (-3dB; reference frequency:1Hz) Signal amplitude: Voh2.5V Pulse width: 10ms5%
Signal rising and falling time: 100s 0 to 40 Hz Maximum transmission delay 30 ms Gain (reference frequency 1 Hz) 1 V/100 mmHg, 5%
Nurse Call Signal Amplitude High level: 3.5 to 5 V, 5%, providing a minimum of 10 mA output current;
Low level: < 0.5 V, receiving a minimum of 5 mA input current. Rising and falling time 1 ms Defib Sync Pulse Output impedance Maximum time delay 100 ohm 35 ms (R-wave peak to leading edge of pulse) A - 5 Amplitude Pulse width High level: 3.5 to 5 V, 5%, providing a maximum of 10 mA output current;
Low level: < 0.5 V, receiving a maximum of 5 mA input current. 100 ms 10%
maximum rising and falling time 1 ms Alarm Output Alarm delay time from the monitor to remote equipment The alarm delay time from the monitor to remote equipment is 2 seconds, measured at the monitor signal output connector. Alarm signal sound pressure level range 45 db(A) to 85 db(A) within a range of one meter A.11 Data Storage Trends Events Standard-capacity memory card: up to 120 hours trend data with the resolution no less than 1 minute. High-capacity memory card: up to 240 hours trend data with the resolution no less than 1 seond, or up to 2400 hours trend data with the resolution no less than 10 minutes. Standard-capacity memory card: 1000 events, including parameter alarms, arrhythmia events, technical alarms, and so on. High-capacity memory card: 2000 events, including parameter alarms, arrhythmia events, technical alarms, and so on. NIBP measurements Standard-capacity memory card: 1000 sets. High-capacity memory card: 3000 sets. Interpretation of resting 12-lead ECG results 20 sets Full-disclosure waveforms ST view OxyCRG view Standard-capacity memory card: up to 48 hours for all parameter waveforms. The specific storage time depends on the waveforms stored and the number of stored waveforms. High-capacity memory card: up to 48 hours for all parameter waveforms. A maximum of 120 hours ST segment waveforms. One group of ST segment waveforms is stored every minute. 400 OxyCRG events. A.12 Wi-Fi Specifications A.12.1 Wi-Fi Technical Specifications Protocol Modulation mode Operating frequency IEEE 802.11a/b/g/n DSSS and OFDM IEEE 802.11b/g/n (at 2.4G) IEEE 802.11a/n (at 5G) ETSI: 2.4 GHz to 2.483 GHz FCC: 2.4 GHz to 2.483 GHz MIC: 2.4 GHz to 2.495GHz KC: 2.4 GHz to 2.483 GHz ETSI: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz FCC: 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.82 GHz MIC: 5.15GHz to 5.35 GHz KC: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz, 5.725 GHz to 5.82 GHz Channel spacing IEEE 802.11b/g: 5 MHz IEEE 802.11n (at 2.4 G): 5 MHz IEEE802.11a: 20 MHz IEEE802.11n (at 5 G): 20 MHz A - 6 Wireless baud rate Output power Operating mode Data security IEEE 802.11b: 1 Mbps to 11 Mbps IEEE 802.11g: 6 Mbps to 54 Mbps IEEE 802.11n: 6.5 Mbps to 72.2 Mbps IEEE 802.11a: 6 Mbps to 54 Mbps
<20dBm (CE requirement, detection mode: RMS)
<30dBm (FCC requirement: detection mode: peak power) Infrastructure Standards: WPA-PSK, WPA2-PSK, WPA-Enterprise,WPA2-Enterprise EAP method: EAP-FAST. EAP-TLS, EAP-TTLS, PEAP-GTC, PEAP- MSCHAPv2, PEAP-TLS, LEAP Encryption: TKIP, AES A.12.2 Wi-Fi Performance Specifications WARNING Do perform all network functions of data communication within an enclosed network. A.12.2.1 System Capacity and Resistance to Wireless Interference Meets the following requirements:
All the monitors do not encounter communication loss. The total delay of data transmission from the monitor to the CMS: 2 seconds. The delay for monitor-related settings configured at the CMS to be effective: 2 seconds. The total delay of data transmission from one monitor to the other: 2 seconds. The delay for the monitor to reset alarms of another to be effective: 2 seconds. Testing conditions are as follows:
Number of the monitors supported by a single AP: 16. Each monitor can communicate with the CMS. Two monitors are used to view other monitors. Only one monitor can transmit history data. The weakest strength of the AP signal where the monitor is located is not less than -65 dBm. The distance between the interfering devices and the monitor is greater than 20 cm. A Wi-Fi interference
(no greater than -85 dBm) in the same channel and a Wi-Fi interference (no greater than -50 dBm) in an adjacent-channel are presented synchronously. The interfering devices include, but are not limited to, 2.4 G wireless devices, cellular mobile networks, microwave ovens, interphones, cordless phones, and ESU equipment. The interfering devices do not include Wi-Fi devices. A.12.2.2 Wi-Fi Network Stability The ratio of the communication data loss on the CMS from any monitor does not exceed 0.1% over a 24-hour period. 12 of the 16 monitors connected to the network roam for 30 times. Testing conditions are as follows:
Number of the monitors supported by a single AP: 16. Each monitor can communicate with the CMS. Two monitors are used to view other monitors. Only one monitor can transmit history data. The weakest strength of the AP signal where the monitor is located cannot be less than -65 dBm. A - 7 A.12.2.3 Distinct Vision Distance The distinct vision distance between the monitor and the AP is no less than to 50 meters. A.13 Measurement Specifications The adjustable range of alarm limits is the same with the measurement range of signals unless otherwise specified. A.13.1 ECG Specifications ECG Standards Lead set ECG standard Display sensitivity Sweep speed Bandwidth (-3dB) Common mode rejection ratio Notch filter Meet standards of IEC 60601-2-27: 2011 and IEC 60601-2-25: 2011 3-lead:
5-lead:
6-lead:
12-lead:
AHA, IEC I, II, III I, II, III, aVR, aVL, aVF, V I, II, III, aVR, aVL, aVF, Va, Vb I, II, III, aVR, aVL, aVF, V1 to V6 1.25 mm/mV (0.125), 2.5 mm/mV (0.25), 5 mm/mV (0.5), 10 mm/mV (1), 20 mm/mV (2), 40 mm/mV (4), Auto, less than 5% error 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s, less than 5% error Diagnostic mode:
Monitor mode:
Surgical mode:
ST mode:
High Freq Cut-off (for 12-lead ECG analysis) 0.05 to 150 Hz 0.5 to 40 Hz 1 to 20 Hz 0.05 to 40 Hz 350 Hz, 150 Hz, 35 Hz, or 20 Hz, selectable Diagnostic mode:
Monitor mode:
Surgical mode:
ST mode:
>90 dB
>105 dB (with notch filter on)
>105 dB (with notch filter on)
>105 dB (with notch filter on) 50/60 Hz Monitor, surgical, and ST mode: notch filter turns on automatically Diagnostic mode and High Freq Cut-off: notch filter is turned on/off manually Differential input impedance 5 M Input signal range 10 mV (peak-to-peak value) Accuracy of signal reproduction Use A and D methods based on IEC 60601-2-25 to determine frequency response. Electrode offset potential tolerance 800 mV Lead-off detection current Input offset current Defibrillation protection Measuring electrode: <0.1 A Drive electrode: <1 A 0.1 A, (drive lead1A) Enduring 5000V (360 J) charge without data loss or corruption Baseline recovery time: <5 s (after defibrillation) Polarization recovery time: <10 s Defibrillation energy absorption: 10% (100 load) Patient leakage current
<10 uA Calibration signal 1mV (peak-to-peak value) 5%
A - 8 ESU protection Pace Pulse Pace pulse markers Cut mode: 300 W Coagulate mode: 100 W Recovery time: 10 s In compliance with the requirements in clause 202.6.2.101 of IEC 60601-2-27 Pace pulses meeting the following conditions are labelled with a PACE marker:
Amplitude:
Width:
Rise time:
No overshoot 2 to 700 mV 0.1 to 2 ms 10 to 100 s (no greater than 10% of pulse width) Pace pulse rejection When tested in accordance with the IEC 60601-2-27: 201.12.1.101.13, the heart rate meter rejects all pulses meeting the following conditions. HR Measurement range Resolution Accuracy Sensitivity HR averaging method Response to irregular rhythm Amplitude:
Width:
Rise time:
No overshoot Neonate:
Pediatric:
Adult:
1 bpm 2 to 700 mV 0.1 to 2 ms 10 to 100 s (no greater than 10% of pulse width) 15 to 350 bpm 15 to 350 bpm 15 to 300 bpm 1 bpm or 1%, whichever is greater. 200 V (lead II) In compliance with the requirements in Clause 201.7.9.2.9.101 b) 3) of IEC 60601-2-27, the following method is used:
If the last 3 consecutive RR intervals are greater than 1200 ms, the 4 most recent RR intervals are averaged to compute the HR. Otherwise, heart rate is computed by subtracting the maximum and minimum ones from the most recent 12 RR intervals and then averaging them. The HR value displayed on the monitor screen is updated no more than one second. In compliance with the requirements in Clause 201.7.9.2.9.101 b) 4) of IEC 60601-2-27, the heart rate after 20 seconds of stabilization is displayed as follows:
Ventricular bigeminy (waveform A1): 801 bpm Slow alternating ventricular bigeminy (waveform A2): 601 bpm Rapid alternating ventricular bigeminy (waveform A3): 1201 bpm Bidirectional systoles (waveform A4): 902 bpm Response time to heart rate change Meets the requirements of IEC 60601-2-27: Clause 201.7.9.2.9.101 b) 5). From 80 to 120 bpm:
From 80 to 40 bpm:
less than 11 s less than 11 s Time to alarm for tachycardia Meets the requirements in Clause 201.7.9.2.9.101 b) 6) of IEC 60601-2-27. Waveform B1h-range:
B1-range:
B1d-range:
B2h-range:
B2-range:
B2d-range:
<11 s
<11 s
<11 s
<11 s
<11 s
<11 s A - 9 Tall T-wave rejection capability Arrhythmia Analysis Classifications When the test is performed based on Clause 201.12.1.101.17 of IEC 60601-2-
27, the heart rate calculation is not affected for QRS of 1 mV amplitude and 100 ms duration, T-wave duration of 180 ms and amplitude lower than 1.2 mV, and QT interval of 350 ms. Asystole, V-Fib/V-Tac, V-tac, Vent-. Brady, Extreme Tachy, Extreme Brady, Vent Rhythm, PVCs/min, Pauses/min, Couplet, Bigeminy, Trigeminy, R on T, Run PVCs, PVC, Tachy, Brady, Missed Beats, Pacer Not Paceing, Pacer Not Capture, Multiform PVC, Nonsus. V-Tac, Pause, Irr. Rhythm, A-Fib ST Segment Analysis Measurement range Accuracy Resolution QT/QTc Analysis Measurement range Accuracy Resolution 12-lead ECG Interpretation Sampling rate Amplitude quantisation Alarm limit HR High HR Low ST High ST Low QTc High QTc High
-2.5 to 2.5 mV RTI
-0.8 to 0.8 mV:
Beyond this range:
0.02 mV or 10%, whichever is greater. Not specified. 0.01mV QT: 200 to 800 ms QTc: 200 to 800 ms QT-HR: 15 to 150 bpm for adult, 15 to 180 bpm for pediatric and neonate QT: 30 ms QT: 4 ms QTc: 1 ms 1000 samples/s (A/D) 500 samples/s (ECG algorithm) 24 bits Range Step HR40bpm: (low limit + 2 bpm) to 40 bpm HR > 40 bpm: (low limit + 5 bpm) to 295 bpm HR40bpm: 1 bpm HR > 40 bpm: 5 bpm HR40bpm: 16 bpm to (low limit - 2 bpm) HR > 40 bpm: 40 bpm to (low limit - 5 bpm)
(low limit + 0.2 mV) to 2.0 mV (ST alarm mode:
Absolute) 0 mV to 2.0 mV (ST alarm mode: Relative) 0.01 mV
-2.0 mV to (high limit - 0.2 mV) (ST alarm mode:
Absolute)
-2.0 mV to 0 mV (ST alarm mode: Relative) 200 to 800 ms 30 to 200 ms 10 ms A.13.2 Resp Specifications Technique Lead Trans-thoracic impedance Options are lead I, II and Auto. Respiration excitation waveform
<300 A RMS, 62.8 kHz (10%) Minimum respiration impedance threshold 0.3 Baseline impedance range 200 to 2500 (using an ECG cable with 1k resistance) A - 10 Differential input impedance
>2.5 M Bandwidth Sweep speed Recovery time Respiration Rate Measurement range Resolution Accuracy 0.2 to 2.5 Hz (-3 dB) 3mm/s, 6.25 mm/s, 12.5 mm/s, 25 mm/s or 50 mm/s, less than 10% error
<15 s (after defibrillation) 0 to 200 rpm 1 rpm 0 to 120 rpm: 1 rpm 121 to 200 rpm: 2 rpm Apnea alarm time 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Alarm limit RR High RR Low Step (rpm) RR20: 1 RR>20: 5 Range (rpm) Adult, Pediatric:
RR20 RR>20 Neonate:
RR20 RR>20 RR20:
RR>20:
(low limit + 2) to 20
(low limit + 5) to 100
(low limit + 2) to 20
(low limit + 5) to 150 0 to (high limit - 2) 20 to (high limit - 5) A.13.3 SpO2 Specifications Refer to Appendix F SpO2 Sensor Accuracy for the clinical study results of SpO2 sensor accuracy. Alarm limit SpO2 High SpO2 Low Range (%)
(low limit + 2) to 100 Step (%) 1 Masimo: (Desat+1) to (high limit - 2) Nellcor: (Desat+1) or 20 (whichever is greater) to
(high limit - 2) SpO2 Desat Low 0 to (high limit - 1) Masimo SpO2 Module Standards Measurement range Resolution Response time Accuracy1 meets the requirements of ISO 80601-2-61: 2011 1 to 100%
1%
20 s (normal perfusion, no disturbance, SpO2 value sudden changes from 70% to 100%) 70 to 100%: 2% (measured without motion in adult/pediatric mode) 70 to 100%: 3% (measured without motion in neonate mode) 70 to 100%: 3% (measured with motion) 1% to 69%: Not specified. Refresh rate 1 s SpO2 averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s Low perfusion conditions Pulse amplitude: >0.02%
Light penetration: >5%
Low perfusion SpO2 accuracy2 2%
A - 11 PI measurement range 0.02 to 20%
1 The Masimo pulse oximeter with sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin. The Masimo pulse oximeter with sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz. At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70% to 100% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. 2 The Masimo pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population. Mindray SpO2 Module Standards Meet standards of ISO 80601-2-61: 2011
*Measurement accuracy verification: The SpO2 accuracy has been verified in human experiments by comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurement are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-
oximeter measurements. Measurement range Resolution Response time Accuracy 0 to 100%
1%
< 30 s (normal perfusion, no disturbance, SpO2 value sudden changes from 70% to 100%) 70 to 100%: 2% (adult/pediatric mode) 70 to 100%: 3% (neonate mode) 0% to 69%: Not specified.
* One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal hemoglobin. Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO2 sensors by contrast with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved in this study. The statistical analysis of data of this study shows the accuracy (Arms) is within the stated accuracy specification. Please see the following table. Sensor type Totally neonates 518B 520N 97 (51 male & 46 female) 122 (65 male & 57 female) Data 200 pairs 200 pairs Arms 2.38%
2.88%
The Pulse Oximeter with neonatal SpO2 sensors was also validated on adult subjects. Refreshing rate Sensitivity Recovery time PI 1 s High, Medium, Low
<15 s (after defibrillation) Measurement range 0.05 to 20%
Resolution 0.05%~9.99%: 0.01%
10.0%~20.0%: 0.1%
Nellcor SpO2 Module Measurement range Resolution Refreshing rate 0 to 100%
1%
1 s A - 12 Response time Recovery time Accuracy 30 s (normal perfusion, no disturbance, SpO2 value sudden change from 70% to 100%)
<15 s (after defibrillation) 70 to 100%: 2% (adult/pediatric) 70 to 100%: 3% (neonate) 0% to 69%: Not specified. When the SpO2 sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by 1%, to compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood. A.13.4 PR Specifications Alarm limit PR High PR Low PR from Masimo SpO2 Measurement range Resolution Response time Accuracy Refresh rate Sensitivity PR from Mindray SpO2 Module Measurement range Resolution Response time Accuracy Refreshing rate Sensitivity PR from Nellcor SpO2 Module Measurement range Resolution Response time Accuracy Range PR40bpm: (low limit + 2 bpm) to 40 bpm PR > 40 bpm: (low limit + 5 bpm) to 295 bpm PR40bpm: 16 bpm to (high limit - 2 bpm) PR > 40 bpm: 40 bpm to (high limit - 5 bpm) Step PR40: 1 PR>40: 5 25 to 240 bpm 1 bpm 20 s (with normal perfusion, no disturbance, and a PR value transition from 25 to 220 bpm) 3 bpm (measured without motion) 5 bpm (measured with motion) 1 s High, Medium, Low 20 to 300 bpm 1 bpm
<30 s (normal perfusion, no disturbance, PR value sudden changes from 25 to 220bpm) 3 bpm 1 s High, Medium, Low 20 to 300 bpm 1 bpm 30 s (normal perfusion, no disturbance, PR value sudden change from 25 to 250 bpm) 20 to 250 bpm: 3 bpm 251 to 300 bpm, not specified Refreshing rate 1 s PR from NIBP Module A - 13 Measurement range Resolution Accuracy PR from IBP Module Measurement range Resolution Accuracy A.13.5 Temp Specifications Standard Technique Operating mode Measurement range Resolution Accuracy Refreshing rate Minimum time for accurate measurement Recovery time Alarm limit TXX High (XX refers to temperature site) TXX Low (XX refers to temperature site) TD High 30 to300 bpm 1 bpm 3bpm or 3%, whichever is greater 20 to 350 bpm 1 bpm 1 bpm or 1%, whichever is greater Meet the standard of ISO 80601-2-56: 2009 Thermal resistance Direct mode 0 to 50 C (32 to 122 F) 0.1C 0.1 C or 0.2 F (excluding probe error) 1 s Body surface: <100 s Body cavity: <80 s
<15 s (after defibrillation) Range
(low limit +1.0) to 50.0 C
(low limit +2.0) to 122.0 F 0.1 to (high limit - 1.0) C 32.2 to (high limit - 2.0) F 0.1 to 50.0 C 0.2 to 90.0 F Step 0.1 C 0.1 F A.13.6 NIBP Specifications Standard Technique Meet standard of ISO 80601-2-30: 2013 Oscillometry Mode of operation Manual, Auto, STAT, Sequence Auto mode repetition intervals 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 60, 90, 120, 180, 240 or 480 min STAT mode cycle time Max measurement time Heart rate range Measurement ranges
(mmHg) 5 min Adult, Pediatric: 180 s Neonate: 90 s 30 to 300 bpm Systolic:
Diastolic:
Mean:
Adult Pediatric Neonate 25 to 290 25 to 240 25 to 140 10 to 250 10 to 200 10 to 115 15 to 260 15 to 215 15 to 125 A - 14 Accuracy Resolution Initial cuff inflation pressure range
(mmHg) Default initial cuff inflation pressure
(mmHg) Software overpressure protection Max mean error: 5 mmHg Max standard deviation: 8 mmHg 1mmHg Adult: 80 to 280 Pediatric: 80 to 210 Neonate: 60 to 140 Adult: 160 Pediatric: 140 Neonate: 90 Adult: 2973 mmHg Pediatric: 2973 mmHg Neonate: 1473 mmHg Static pressure measurement range 0 mmHg to 300 mmHg Static pressure measurement accuracy 3 mmHg Recovery time Alarm limit NIBP-S High NIBP-S Low NIBP-M High NIBP-M Low NIBP-D High Step (mmHg) NIBP 50: 1 NIBP > 50: 5
<15 s (after defibrillation) Range (mmHg) Adult: (low limit + 5) to 290 Pediatric: (low limit + 5) to 240 Neonate: (low limit + 5) to 140 25 to (high limit - 5) Adult: (low limit + 5) to 260 Pediatric: (low limit + 5) to 215 Neonate: (low limit + 5) to 125 15 to (high limit - 5) Adult: (low limit + 5) to 250 Pediatric: (low limit + 5) to 200 Neonate: (low limit + 5) to 115 NIBP-D Low 10 to (high limit - 5)
*Measurement accuracy verification: In adult and pediatric modes, the blood pressure measurements measured with this device are in compliance with the Standard for Non-invasive sphygmomanometers (ISO 81060-2)in terms of mean error and standard deviation by comparing with intra-arterial or auscultatory measurements
(depending on the configuration) in a typical patient population. For auscultatory reference, the 5th Korotkoff sound was used to determine the diastolic pressure. In neonatal mode, the blood pressure measurements measured with this device are in compliance with the American National Standard for Non-invasive sphygmomanometers (ISO 81060-2) in terms of mean error and standard deviation by comparing with intra-arterial measurements (depending on the configuration) in a typical patient population. A.13.7 IBP Specifications Standard Technique IBP Measurement range Resolution Accuracy Refreshing rate Meet the standard of IEC 60601-2-34: 2011 Direct invasive measurement
-50 to 360 mmHg 1 mmHg 2% or 1 mmHg, whichever is greater (excluding sensor error) 1 s A - 15 Recovery time PPV Measurement range Pressure transducer Excitement voltage Sensitivity Zero adjustment range Impedance range Volume displacement Alarm limit Sys High Mean High Dia High Sys Low Mean Low Dia Low Art-S Extreme High Art-M Extreme High Art-D Extreme High Art-S Extreme Low Art-M Extreme Low Art-D Extreme Low A.13.8 C.O. Specifications Measurement method Measurement range Resolution Accuracy Repeatability Alarm range Recovery time Alarm limit TB High TB Low A - 16
<10 s (after defibrillation) 0% ~ 50%
5 VDC, 2%
5 V/V/mmHg 200 mmHg 300 to 3000
<0.04 mm3 /100 mmHg Range (mmHg) IBP 50: (low limit + 2) to 50 IBP > 50: (low limit + 5) to 360 IBP 50: -50 to (high limit - 2) IBP > 50: 50 to (high limit - 5) High limit to 360
-50 to low limit Step (mmHg) IBP 50: 1 IBP > 50: 5 IBP 50: 1 IBP > 50: 5 Thermodilution method C.O.:
TB:
TI:
C.O.:
TB, TI:
C.O.:
TB, TI:
C.O.:
TB:
0.1 to 20 L/min 23 to 43 C 0 to 27 C 0.1 L/min 0.1 C 5% or 0.1 L /min, whichever is greater 0.1 C (without sensor) 2% or 0.1 L/min, whichever is greater 23 to 43 C
<15 s (after defibrillation) Range
(low limit + 1) to 43 C
(low limit + 2) to 109.4 F 23 to (high limit - 1) C 73.4 to (high limit - 2) F Step 0.1 C 0.1 F A.13.9 CO2 Specifications Measurement mode Sidestream, microstream, mainstream Technique Apnea time Alarm limit EtCO2 High EtCO2 Low FiCO2 High EtO2 High EtO2 Low FiO2 High FiO2 Low Infrared absorption 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s Range
(low limit + 2) to 99 mmHg 1 to (high limit - 2)mmHg 1 to 99 mmHg
(low limit + 2%) to 100%
18% to (high limit - 2)%
(low limit + 2%) to 100%
0% to (high limit - 2)%
Step 1 mmHg 1%
Sidestream CO2 Module Standard Meet the standard of ISO 80601-2-55: 2011 CO2 Measurement range CO2 absolute accuracy*
0 to 150 mmHg Full accuracy mode:
0 to 40 mmHg: 2 mmHg 41 to 76 mmHg: 5% of reading 77 to 150 mmHg: 10% of reading Inaccuracy specifications are affected by the breath rate and I:E. The EtCO2 accuracy is within specification for breath rate 60 rpm and I/E ratio 1:1, or breath rate 30 rpm and I/E ratio 2:1. ISO accuracy mode: add 2mmHg to the full accuracy mode CO2 resolution Recovery time O2 measurement range O2 absolute accuracy O2 resolution Accuracy drift Sample flowrate 1 mmHg
<15 s (after defibrillation) 0 to 100%
0O2 concentration25%: 1%
25<O2 concentration80%: 2%
80<O2 concentration100%: 3%
0.1%
Meet the requirement for measurement accuracy within 6 hours For sidestream CO2 module without O2 monitoring function:
Connected a DRYLINE II watertrap for adult and pediatric patient: 120 ml/
min Connected a DRYLINE II watertrap for neonatal patient: 90 ml/min or 70 ml/
min For sidestream CO2 module with O2 monitoring function:
Connected a DRYLINE II watertrap for adult and pediatric patient: 120 ml/
min Connected a DRYLINE II watertrap for neonatal patient: 90 ml/min Sample flowrate tolerance 15% or 15 ml/min, whichever is greater. Start-up time Maximum: 90 s Typically: 20 s A - 17 Response time Rise time For CO2 measurement (without O2 measurement):
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
5.0 s @ 70 ml/min 4.5 s @ 90 ml/min Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
5.0 s @ 120 ml/min For CO2 measurement (with O2 measurement):
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
4.5 s@90 ml/min. Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
5 s@120 ml/min For O2 measurements:
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
4.5 s @ 90 ml/min Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
5 s@120 ml/min For CO2 measurement (without O2 measurement):
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
250 ms@70 ml/min. 250 ms@90 ml/min. Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
300 ms@120 ml/min For CO2 measurement (with O2 measurement):
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
250 ms@90 ml/min. Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
300 ms@120 ml/min 240 ms@150 ml/min For O2 measurements:
Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
800 ms@90 ml/min. Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
750 ms@120 ml/min awRR measurement range 0 to 150 rpm awRR measurement precision awRR resolution Data sample rate 60 rpm: 1 61 to 150 rpm: 2 1 rpm 50 Hz Effect of interference gases on CO2 measurements Gas Concentration (%) Quantitative effect*
A - 18 O2 N2O Hal Sev Iso Enf Des 100 60 4 5 5 5 15 1 mmHg 2 mmHg
*: means an extra error should be added in case of gas interference when CO2 measurements are performed between 0 to 40mmHg. Effect of interference gases on O2 measurements Gas CO2 N2O Hal, Des, Sev, Iso, Enf Microstream CO2 Module Quantitative effect 0.2%
0.2%
1%
Standard Meet the standard of ISO 80601-2-55: 2011 CO2 Measurement range Accuracy*
0 to 150 mmHg 0 to 38 mmHg:
39 to 150 mmHg:
2 mmHg 5% of the reading (0.08% increased in error for every 1 mmHg if the reading is more than 38 mmHg) Accuracy drift Meet the requirement for measurement accuracy within 6 hours
* Accuracy applies for respiration rate up to 80 rpm. For respiration rate above 80 rpm and EtCO2 exceeding 18 mmHg, the accuracy is 4 mmHg or 12% of the reading, whichever is greater. For respiration rate above 60 rpm, the above accuracy can be achieved by using the FilterLine H Set for Infant/Neonatal (Model: 006324). In the presence of interfering gases, the above accuracy is maintained to within 4%. Resolution Recovery time Sample flow rate Initialization time Response time 1 mmHg
<15 s (after defibrillation) 50
+15
-7.5 ml/min 30 s (typical) 180 s (maximum) 2.9 s (typical)
(The response time is the sum of the rise time and the delay time when using a FilterLine of standard length) Rise time: <190 ms (10% to 90%) Delay time: 2.7 s (typical) awRR measurement range awRR measurement accuracy awRR resolution Data sample rate 0 to 150 rpm 0 to 70 rpm:
71 to 120 rpm:
121 to 150 rpm:
1 rpm 40 Hz 1 rpm 2 rpm 3 rpm A - 19 Mainstream CO2 Module Standard Meet the standard of ISO 80601-2-55: 2011 CO2 Measurement range Accuracy Accuracy drift Resolution Recovery time Rise time Data sample rate 0 to 150 mmHg 0 to 40 mmHg:
41 to 70 mmHg:
71 to 100 mmHg:
101 to 150 mmHg:
2 mmHg 5% of the reading 8% of the reading 10% of the reading Meet the requirement for measurement accuracy within 6 hours 1 mmHg
<15 s (after defibrillation)
<60 ms 100 Hz awRR measurement range 0 to 150 rpm awRR measurement accuracy awRR resolution 1 rpm 1 rpm A.13.10 AG Specifications Standard Technique Recovery time Warm-up time Sample flow rate Measurement range Resolution Iso accuracy A - 20 Meet the standard of ISO 80601-2-55: 2011 Infrared absorption, paramagnetic properties for O2 monitoring
<15 s (after defibrillation) Iso accuracy mode:
Full accuracy mode:
45 s 10 min Adult, Pediatric:
Neonate:
Accuracy:
200 ml/min 120 ml/min 10 ml/min or 10%, whichever is greater CO2:
O2:
N2O:
Des:
Sev:
Enf:
Iso:
Hal:
awRR:
CO2:
O2:
N2O:
Des:
Sev:
Enf:
Iso:
Hal:
awRR:
0 to 30%
0 to 100%
0 to 100%
0 to 30%
0 to 30%
0 to 30%
0 to 30%
0 to 30%
2 to 100 rpm 0.1%
1%
1%
0.1%
0.1%
0.1%
0.1%
0.1%
1 rpm As full accuracy specifications, but derated as follows:
Add 0.3%ABS to accuracy for CO2 Add 8%REL to accuracy for all anesthetic gases N2O accuracy is (8%REL+2%ABS) Full accuracy Accuracy drift Apnea alarm time Refreshing rate Rise time
(10% ~ 90%) Delay time Range (%REL)1 Accuracy (%ABS) Gases CO2 N2O O2 Des Sev Enf, Iso, Hal 0CO21 1<CO25 5<CO27 7<CO210 CO2>10 0 to 20 20 to 100 0 to 25 25 to 80 80 to 100 0 to 1 1 to 5 5 to 10 10 to 15 15 to 18
>18 0 to 1 1 to 5 5 to 8
>8 0 to 1 1 to 5
>5 0.1 0.2 0.3 0.5 Not specified 2 3 1 2 3 0.15 0.2 0.4 0.6 1 Not specified 0.15 0.2 0.4 Not specified 0.15 0.2 Not specified 1 rpm Not specified awRR 2 to 60 rpm
>60 rpm Note1: The highest GAS LEVEL for a single halogenated anaesthetic gas in a gas mixture that is concealed when the anaesthetic concentration falls is 0.15/0.3% (Full/ISO accuracy). Meet the requirement for measurement accuracy within 6 hours 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s 1 s Gas sample flow rate 120ml/min, using a DRYLINE II neonatal watertrap and sampling line (2.5m):
CO2 N2O Hal, Iso, Sev, Des Enf O2 250 ms 250 ms 300 ms 350 ms 600 ms Gas sample flow rate 200ml/min, using the adult DRYLINE II water trap and sampling line (2.5m):
CO2 N2O O2 Hal, Iso, Sev, Des Enf
<4 s 250 ms 250 ms 500 ms 300 ms 350 ms A - 21 Response time Measured with a DRYLINE II neonatal watertrap and a 2.5-meter neonatal sampling line:
120 ml/min:
CO2:
N2O:
O2:
Hal, Iso, Sev, Des, Enf:
4 s 4.2 s 4 s 4.4 s Measured with a DRYLINE II adult watertrap and a 2.5-meter adult sampling line:
200 ml/min:
CO2:
N2O:
Hal, Iso, Sev, Des, Enf:
O2:
Primary anesthetic agent In full accuracy mode: 0.15%, 4.2s 4.3s 4.5s 4s Anesthetic agent limit Secondary anesthetic agent:
In full accuracy mode: 5% of primary agent if primary agent is greater than 10%, 0.3% if primary agent is less than or equal to 10%. Data sample rate 25 Hz Inaccuracy specifications are affected by the breath rate and I:E change. The end-tidal gas reading is within specification for breath rate below 15BPM and I:E ratio smaller than 1:1 relative to the gas readings without breath; Add 6%REL to inaccuracy for HAL and O2 for breath rate larger than 15 BPM; Add 6%REL to inaccuracy for all gases for breath rate larger than 30 BPM (inaccuracy for HAL and O2 are unspecified in this case); inaccuracy is unspecified for breath rate larger than 60 BPM. Effect of interference gases on AG measurements Gas CO2 N2O Agent 1) 2) Xenon Helium Ethanol Acetone Methane Saturated Isopropanol vapour Metered dose inhaler propellants, O2 Concentration
(%) Quantitative effect(%ABS)3) CO2 N2O Agent 1)
/
0.1 0.1 0.1 0.1 0 0.1 0.1 0.1 0.1
/
0.1 0 0 0 0.1 0 0 0 0.1 0.1 0 0 0 0 0 0 O2 0.2 0.2 1 0.5 0.5 0.5 0.5 0.5 0.5 Unspecifie d Unspecifie d Unspecifie d Unspecifie d 0.2 0.2 1.0
/
/
/
/
<100%
<50%
<0.1%
<1%
<1%
/
/
/
1) Agent represents one of Des, Iso, Enf, Sev, and Hal. 2) Multiple agent interference on CO2, N2O and O2 is typically the same as single agent interference. 3) For CO2, N2O and Agents, maximum interference from each gas at concentrations within specified accuracy ranges for each gas. The total interference of all gases is never larger than 5%REL. Alarm limit Range Step A - 22 EtCO2 High EtCO2 Low FiCO2 High EtO2 High EtO2 Low FiO2 High FiO2 Low EtN2O High EtN2O Low FiN2O High FiN2O Low EtHal/Enf/Iso High EtHal/Enf/Iso Low FiHal/Enf/Iso High FiHal/Enf/Iso Low EtSev High EtSev Low FiSev High FiSev Low EtDes High EtDes Low FiDes High FiDes Low
(low limit + 2) to 99 mmHg 1 mmHg 1 to (high limit - 2)mmHg 1 to 99 mmHg
(low limit + 2%) to 100%
18% to (high limit - 2)%
(low limit + 2%) to 100%
0% to (high limit - 2)%
(low limit + 2) to 100%
0 to (high limit - 2)%
(low limit + 2) to 100%
0 to (high limit - 2)%
(low limit + 0.2) to 5.0%
0 to (high limit - 0.2)%
(low limit + 0.2) to 5.0%
0 to (high limit - 0.2)%
(low limit + 0.2) to 8.0%
0 to (high limit - 0.2)%
(low limit + 0.2) to 8.0%
0 to (high limit - 0.2)%
(low limit + 0.2) to 18.0%
0 to (high limit - 0.2)%
(low limit + 0.2) to 18.0%
0 to (high limit - 0.2)%
1%
1%
0.1%
0.1%
0.1%
A - 23 B EMC and Radio Regulatory Compliance B.1 EMC The device meets the requirements of IEC 60601-1-2: 2014. WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be disrupted by the electromagnetic interference of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the non-ME EQUIPMENT or shielding the location. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. This device is intended for use in professional healthcare facility environment and home healthcare environment. If it is used in special environment, such as magnetic resonance imaging environment, the equipment/system may be disrupted by the operation of nearby equipment. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the this device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Guidance and Declaration - Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment - guidance Conducted and radiated RF EMISSIONS CISPR 11 Group 1 Conducted and radiated RF EMISSIONS CISPR 11 Harmonic distortion EMISSIONS IEC61000-3-2 Class A Class A Voltage Fluctuations/Flicker EMISSIONS IEC 61000-3-3 Complies The device 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 device is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes If the system is operated within the electromagnetic environment listed in Table Guidance and Declaration -
Electromagnetic Immunity, the system will remain safe and provide the following essential performance:
Operating mode Accuracy Function Accessories identification Data stored Alarm Detect for connection B - 1 NOTE If the essential performance is lost or degraded, it may be necessary to take mitigation measures, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM or shielding the location or stopping using the monitor and contact the service personnel. The device needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below. Other devices may interfere with this device even though they meet the requirements of CISPR. When the inputted signal is below the minimum amplitude provided in technical specifications, erroneous measurements could result. The EMISSIONS characteristics of this device make it suitable for use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this device might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the device. Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 8 kV contact 15 kV air 8 kV contact 15 kV air 2 kV for power supply lines 1 kV for input/
output lines 2 kV for power supply lines 1 kV for input/
output lines Surge IEC 61000-4-5 1 kV line(s) to line(s) 2 kV line(s) to earth 1 kV line(s) to line(s) 2 kV line(s) to earth Voltage dips and voltage interruptions IEC 61000-4-11 0% UT for 0.5 cycle: at 0, 45, 90, 135, 180, 225, 270 and 315 0% UT for 0.5 cycle: at 0, 45, 90, 135, 180, 225, 270 and 315 0% UT for 1 cycle and 70% UT for 25/30 cycles: at 0 0% UT for 1 cycle and 70% UT for 25/30 cycles: at 0 0% UT for 250/300 cycle 0% UT for 250/300 cycle 30 A/m 50 Hz/60 Hz 30 A/m 50 Hz/60 Hz RATED power frequency magnetic fields IEC 61000-4-8 Note: UT is the AC mains voltage prior to application of the test level. 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 or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of our product requires continued operation during power mains interruptions, it is recommended that our product be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. B - 2 Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specified electromagnetic environment. The customer or the user of the device should assure that it is used in such an environment as described below. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the system, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distances:
d 1.2 P
=
d
=
1.2 P
=
2.3 P Recommended separation distances:
80 MHz to 800 MHz:
d 800MHz - 2.7GHz:
Where, 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)b. Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
Conducted disturbances induced by RF fields IEC61000-4-6 Radiated RF EM fields IEC61000-4-3 3 Vrms 150 kHz to 80 MHz 80% AM at 1 kHz 6 Vrms in ISM bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz 3 V/m 80 MHz to 2,7 GHz 80% AM at 1 kHz 3Vrms 6 Vrms 3V/m Proximity fields from RF wireless communications equipment IEC61000-4-3 27 V/m 28 V/m 28 V/m 9 V/m 27 V/m 385 MHz 28 V/m 810 MHz, 870 MHz, 930 MHz, 1720 MHz, 1845 MHz, 1970 MHz, 2450 MHz (pulse modulation) 28V/m 450 MHz (FM modulation) 9V /m 710 MHz, 745 MHz, 780 MHz, 5240 MHz, 5500 MHz, 5785 MHz Note 1: At 80 MHz to 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a: 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 ME EQUIPMENT or ME SYSTEM is used exceeds the applicable RF compliance level above, the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ME EQUIPMENT or ME SYSTEM. b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m. B - 3 WARNING The device is configured with a wireless network connector to receive wireless signal. Other devices may interfere with this device even though they meet the requirements of CISPR. Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) 0.01 0.1 1 10 100 Separation distance in meters (m) according to frequency of the transmitter 150 kHz to 80 MHz d 1.2 P
=
80 MHz to 800 MHz d 1.2 P
=
800 MHz to 2.7 GHz d 2.3 P
=
0.12 0.38 1.20 3.80 12.00 0.12 0.38 1.20 3.80 12.00 0.23 0.73 2.30 7.30 23.00 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. B.2 Radio Regulatory Compliance RF parameters Type of Radio IEEE 802.11b/g/n (2.4G) IEEE 802.11a/n (5G) Operating Frequency ETSI: 2.4 GHz to 2.483 GHz FCC: 2.4 GHz to 2.483 GHz MIC: 2.4 GHz to 2.495GHz KC: 2.4 GHz to 2.483 GHz ETSI: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz FCC: 5.15 GHz to 5.35 GHz, 5.725 GHz to 5.82 GHz MIC: 5.15GHz to 5.35 GHz KC: 5.15 GHz to 5.35 GHz, 5.47 GHz to 5.725 GHz, 5.725 GHz to 5.82 GHz Modulation Mode DSSS and OFDM OFDM Output Power
< 30 dBm (peak power)
< 20 dBm (average power) The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. This device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the condition that this device does not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. B - 4 WARNING Changes or modifications not expressly approved by the party responsible compliance could void the users authority to operate the equipment. B - 5 C Default Settings C.1 ECG, Arrhythmia, ST and QT Default Settings C.1.1 ECG Default Settings Item HR/PR Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs Adult: 120 bpm Pediatric: 160 bpm Neonate: 200 bpm Adult: 50 bpm Pediatric: 75 bpm Neonate: 100 bpm Med Off Auto II Alarm Source ECG1 ECG2 (5-lead, 6-lead, 12-lead) V, Va, V1 Va (for 6-lead only) Vb(for 6-lead only) ECG Gain Speed Filter Va Vb 1 25 mm/sec OR: Surgery CCU: Diagnostic Other departments: Monitor High FreqCut-off (for 12-lead analysis) Notch Filter Lead Set Smart Lead Baseline Drift Removal (for 12-lead only) 35 Hz On Auto On On Waveform Layout (for 12-lead only) Standard CrozFusion CrozFusion Display QRS Volume QRS Threshold Paced Pacer Reject On Off General, OR: 2 Other department: 0 0.16 mV Adult: Unspecified Pediatric/Neonate: No Off C - 1 C.1.2 Arrhythmia Default Settings C.1.2.1 Arrhythmia Alarm Default Settings Item Asystole V-Fib/V-Tach V-Tach Vent Brady Extreme Tachy Extreme Brady R on T Run PVCs Couplet Multiform PVC PVC Bigeminy Trigeminy Tachy Brady Pacer Not Capture Pacer Not Pacing Missed Beats Nonsus V-Tach Vent Rhythm Pause Irr. Rhythm A-Fib PVCs/min Pauses/min Alarm Switch Priority Alarm Outputs On On On On On On CCU: On Other departments: Off Off Off Off Off CCU: On Other departments: Off CCU: On Other departments: Off Off Off Off Off Off CCU: On Other departments: Off CCU: On Other departments: Off Off Off Off CCU: On Other departments: Off CCU: On Other departments: Off High, unadjustable High, unadjustable High, unadjustable High, unadjustable High, unadjustable High, unadjustable Med Low Prompt Med Prompt Med Med Med Med Prompt Prompt Prompt Med Med Low Prompt Prompt Med Med Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off Off C - 2 C.1.2.2 Arrhythmia Threshold Default Settings Item Asystole Delay Tachy Brady Extreme Tachy Extreme Brady Multiform PVCs Window PVCs/min Pause/min Pause Threshold AF/Irr Rhy End Time V-Tach Rate V Brady Rate V-Tach PVCs V-Brady PVCs C.1.3 ST Default Settings Item ST Alarm Mode ST-I, ST-II, ST-III, ST-aVR, ST-aVL, ST-aVF, ST-V1, ST-
V2, ST-V3, ST-V4, ST-V5,ST-V6, ST-Va, ST-Vb (ST Alarm Mode set to Absolute) ST Single, ST Dual (ST Alarm Mode set to Relative) ST Analysis ST Segment Show Marker ST Point Auto Adjust J ISO Neonate 5 sec 200 bpm 100 bpm 220 bpm 60 bpm 15 beats 10 8 2.0 sec 2 min 160 bpm 40 bpm 6 5 Adult 5 sec 120 bpm 50 bpm 160 bpm 35 bpm 15 beats 10 8 2.0 sec 2 min 130 bpm 40 bpm 6 5 Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Pediatric 5 sec 160 bpm 75 bpm 180 bpm 50 bpm 15 beats 10 8 2.0 sec 2 min 130 bpm 40 bpm 6 5 Default Setting Absolute Off 0.2 mV
-0.2 mV Med Off Off 0.1 mV
-0.1 mV Med Off Off Auto Off J+60 ms On 48
-80 C - 3 C.1.4 QT Default Settings Item QTc QTc QT Analysis QT Lead Default Setting Alarm switch Off High limit Priority Alarm Outputs Alarm switch High limit Priority Alarm Outputs Adult: 500 Pediatric: 480 Neonate: 460 Med Off Off 60 Med Off Off All C.1.5 Glasgow 12-lead ECG Algorithm Default Settings Item Filter Baseline Drift Removal Tachy Brady Waveform Layout Median Complex Measurements Interpretation Interpretation Summary Auto Interval Speed Auto Interval 12-Lead Format Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Default Setting Diagnostic On 100 50 Standard Off On On On 10 mm/mV 25 mm/sec Off 34+1 II V2 V5 C - 4 C.2 Respiration Default Settings Item RR Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs Alarm switch Adult: 30 Pediatric: 30 Neonate: 100 Adult: 8 Pediatric: 8 Neonate: 30 Med Off On Priority High, unadjustable Alarm Outputs Off Adult: 20 sec Pediatric: 20 sec Neonate: 15 sec Auto Adult: Auto Pediatric: Auto Neonate: II 2 6.25 mm/s On Apnea Apnea Delay RR Source Resp Lead Gain Speed Auto Threshold Detection C.3 SpO2 Default Settings Item SpO2 Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs SpO2 Desat Alarm switch Low limit Priority Alarm Outputs Satsecond (for Nellcor SpO2) NIBP Simul Display PI (for MasimoSpO2) Speed Adult: 100%
Pediatric: 100%
Neonate: 95%
90%
Med Off On 80%
High Off Off Off Off 25 mm/s C - 5 Item PR Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs Alarm Source PR Source QRS Volume Display PR Adult: 120 Pediatric: 160 Neonate: 200 Adult: 50 Pediatric: 75 Neonate: 100 Med Off Auto Auto General, OR: 2 Other departments: 0 OR: On Other departments: Off C.4 Temperature Default Settings Item TXX
(XX refers to temperature site) T Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Priority Alarm Outputs Default Setting On 38.0 C 35.0 C Med Off On 2.0 C Med Off C.5 NIBP Default Settings Item NIBP-S Default Setting Alarm switch On High limit Low limit Adult: 160 mmHg Pediatric: 120 mmHg Neonate: 90 mmHg Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 40 mmHg Priority Alarm Outputs Med Off C - 6 Item NIBP-D Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs NIBP-M Alarm switch High limit Low limit Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 60 mmHg Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg Med Off On Adult: 110 mmHg Pediatric: 90 mmHg Neonate: 70 mmHg Adult: 60 mmHg Pediatric: 50 mmHg Neonate: 25 mmHg Priority Alarm Outputs Med Off NIBP-S Extreme Alarm switch High limit Low limit ICU, OR, CCU: On Other departments: Off Adult: 175 mmHg Pediatric: 130 mmHg Neonate: 95 mmHg Adult: 75 mmHg Pediatric: 60 mmHg Neonate: 35 mmHg Priority Alarm Outputs High Off NIBP-D Extreme Alarm switch High limit Low limit ICU, OR, CCU: On Other departments: Off Adult: 105 mmHg Pediatric: 80 mmHg Neonate: 65 mmHg Adult: 35 mmHg Pediatric: 30 mmHg Neonate: 15 mmHg Priority Alarm Outputs High Off C - 7 Item Default Setting NIBP-M Extreme Alarm switch High limit Low limit ICU, OR, CCU: On Other departments: Off Adult: 125 mmHg Pediatric: 100 mmHg Neonate: 75 mmHg Adult: 45 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg Priority Alarm Outputs High Off Initial Pressure Interval Start Mode NIBP End Tone Venipuncture Pressure Display Format Nighttime Start Time End Alarm Limit Display Adult: 160 mmHg Pediatric: 140 mmHg Neonate: 90 mmHg OR: 5 min NICU: 30 min Other departments: 15 min Clock Off Auto Sys/Dia (Mean) 22:00 07:00 ICU, OR, CCU: Off Other departments: On C - 8 C.6 IBP Default Settings Item IBP-S Default Setting Alarm switch On High limit Art/Ao/UAP/BAP/FAP/LV/P1/P2 arterial pressure Adult: 160 mmHg Pediatric: 120 mmHg Neonate: 90 mmHg PA Adult: 35 mmHg Pediatric, Neonate: 60 mmHg Low limit Art/Ao/UAP/BAP/FAP/LV/P3/P4 arterial pressure IBP-D Priority Alarm Outputs Alarm switch High limit Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 55 mmHg PA Adult: 10 mmHg Pediatric, Neonate: 24 mmHg Med Off On Art/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure Adult: 90 mmHg Pediatric: 70 mmHg Neonate: 60 mmHg PA Adult: 16 mmHg Pediatric, Neonate: 4 mmHg Low limit Art/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 20 mmHg PA Adult: 0 mmHg Pediatric, Neonate: -4 mmHg Priority Alarm Outputs Med Off C - 9 Item IBP-M Default Setting Alarm switch On High limit Art/Ao/UAP/BAP/FAP/LV/P1-P2 arterial pressure Adult: 110 mmHg Pediatric: 90 mmHg Neonate: 70 mmHg PA Adult: 20 mmHg Pediatric, Neonate: 26 mmHg ICP/RAP/LAP/UVP/P3-P4 venous pressure Adult: 10 mmHg Pediatric, Neonate: 4 mmHg CVP Adult: 14 mmHg Pediatric, Neonate: 5 mmHg Low limit Art/Ao/UAP/BAP/FAP/LV/P1-P4 arterial pressure Adult: 70 mmHg Pediatric: 50 mmHg Neonate: 35 mmHg PA Adult: 0 mmHg Pediatric, Neonate: 12 mmHg CVP/ICP/RAP/LAP/UVP/P1-P4 venous pressure Adult: 0 mmHg Pediatric, Neonate: 0 mmHg Priority Alarm Outputs Art-S Extreme Alarm switch Med Off Off High limit Low limit Priority Alarm Outputs Art-D Extreme Alarm switch High limit Low limit Adult: 175 mmHg Pediatric: 130 mmHg Neonate: 95 mmHg Adult: 75 mmHg Pediatric: 60 mmHg Neonate: 50 mmHg High Off Off Adult: 105 mmHg Pediatric: 80 mmHg Neonate: 65 mmHg Adult: 35mmHg Pediatric: 30 mmHg Neonate: 15 mmHg Priority Alarm Outputs High Off C - 10 Item Default Setting Art-M Extreme Alarm switch Off High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs ICP/RAP/LAP/UVP venous pressure Art/Ao/BAP/FAP/LV/P1/
P2 arterial pressure UAP/P3/P4 venous pressure PA/CVP Adult: 125 mmHg Pediatric: 100 mmHg Neonate: 75 mmHg Adult: 55 mmHg Pediatric: 40 mmHg Neonate: 30 mmHg High Off On Adult: 130 mmHg Pediatric: 100 mmHg Neonate: 90 mmHg Adult: 50 mmHg Pediatric: 40 mmHg Neonate: 30 mmHg Med Off All Mean only Med 25 mm/sec 0-20 0-160 0-80 0-30 Off Auto CPP Measure (for P1, P2) Measure (for P3, P4) Sensitivity Speed Scale (mmHg) PPV Measure PPV Source PAWP Reference Waveform 1 II Reference Waveform 2 Resp Speed 12.5 mm/sec Overlapping Waveform Setup Display Format PA Scale (mmHg) Left Scale (mmHg) Right Scale (mmHg) CVP Scale (mmHg) ICP Scale (mmHg) PA Scale (mmHg) Speed Gridlines 0-30 0-160 0-20 0-30 0-20 0-30 25 mm/sec Off Sys/Dia (Mean) C - 11 Item Alarm Limit Display Use PA-D as PAWP C.7 C.O. Default Settings Alarm switch High limit Low limit Priority Alarm Outputs Item TB Comp const Auto Start Auto TI C.8 CO2 Default Settings C.8.1 General Settings Default Setting On Off Default Setting On 39.0 C 36.0 C Med Off 0.542 On On Item EtCO2 FiCO2 Apnea Delay RR Source Speed Scale Waveform Type Default Setting Alarm switch On High limit Low limit Priority Alarm Outputs Alarm switch High limit Priority Alarm Outputs Adult, Pediatric: 50 mmHg Neonate: 45 mmHg Adult, Pediatric: 25mmHg Neonate: 30mmHg Med Off On 4 mmHg Med Off Adult, Pediatric: 20 s Neonate: 15 s Auto 6.25 mm/s 50 mmHg Draw C - 12 C.8.2 Sidestream CO2 Default Settings Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Item EtO2 FiO2 BTPS Compensation O2 Compensation AG Compensation N2O Compenation Auto Standby Operating Mode Default Setting On 100%
18%
Med Off On Adult, Pediatric: 100%
Neonate: 90%
18%
Med Off Off 0%
0%
0%
60 min Measure C.8.3 Microstream CO2 Default Settings Item BTPS Compen Maximum Hold Auto Standby Operating Mode Default Setting Off 20 sec Off Measure C.8.4 Mainstream CO2 Default Settings Item Maximum Hold O2 Compensation Balance Gas AG Compensation Operating Mode Default Setting 10 sec Off Room Air 0%
Measure C - 13 C.9 Gas Default Settings Default Setting Alarm switch On Item EtCO2 FiCO2 EtO2 FiO2 EtN2O FiN2O High limit Low limit Priority Alarm Outputs Alarm switch High limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Adult, Pediatric: 50 mmHg Neonate: 45 mmHg Adult, Pediatric: 25mmHg Neonate: 30mmHg Med Off On 4 mmHg Med Off On 100%
18%
Med Off On Adult, Pediatric: 100%
Neonate: 90%
18%
Med Off On 55%
0%
Med Off On 53%
0%
Med Off On 30%
0.0%
Med Off EtAA/FiAA Alarm switch High limit Low limit Priority Alarm Outputs C - 14 Item Default Setting EtHal/EtEnf/EtIso Alarm switch High limit Low limit Priority Alarm Outputs FiHal/FiEnf/FiIso Alarm switch EtSev FiSev EtDes FiDes High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs Alarm switch High limit Low limit Priority Alarm Outputs On 3.0%
0.0%
Med Off On 2.0%
0.0%
Med Off On 6.0%
0.0%
Med Off On 5.0%
0.0%
Med Off On 8.0%
0.0%
Med Off On 6.0%
0.0%
Med Off Apnea Delay RR Source Operating Mode Auto Standby Speed Adult, Pediatric: 20 sec Neonate: 15 sec Auto Measure Off 6.25 mm/sec C - 15 Item Scale Waveform Type O2 compensation C.10 Alarm Default Settings Item Alarm Volume High Alarm Volume Reminder Volume Apnea Delay Printing Duration Default Setting O2: 400 mmHg CO2: 50 mmHg N2O: 50%
Hal, Enf, and Iso: 2.5%
Sev: 4.0%
AA and Des: 9.0%
Draw (for CO2 only) OR: 100%
Other departments: Off Default Setting 2 Alarm Volume + 3 2 Adult: 20 sec Pediatric: 20 sec Neonate: 15 sec 20 sec C.11 Display Default Settings Item Default Setting Primary Screen Choose Screen Normal Screen Display Screen Lock Duration General, CCU: Permanent Other departments: Off Brightness Brightness On Battery Night Mode Brightness Alarm Volume QRS Volume Key Volume NIBP End Tone Stop NIBP 5 1 1 2 1 0 Off Off C - 16 D Alarm Messages D.1 Physiological Alarm Messages This section lists physiological alarms, their default priority, and the actions that can be taken when an alarm occurs. D.1.1 General Physiological Alarm Messages Alarm messages Default priority Cause and solution XX High XX Low Med Med XX value has risen above the high alarm limit or fallen below the low alarm limit. Check the patients condition and check if the patient category and alarm limit settings are correct. Note: XX represents a measurement or parameter label, such as HR, NIBP, PVCs, RR, SpO2, PR, and so on. D.1.2 Arrhythmia Alarm Messages Alarm message Default priority Asystole VFib/VTac Vtac Vent Brady Extreme Tachy Extreme Brady PVCs/min Pauses/min R on T Bigeminy Trigeminy Tachy Brady Multiform PVC Vent. Rhythm Nonsus. Vtac Run PVCs Pause Couplet PVC Irr Rhythm Pacer Not Pacing Pacer Not Capture High High High High High High Med Med Med Med Med Med Med Med Med Med Low Low Prompt Prompt Prompt Prompt Prompt D - 1 Alarm message Missed Beats A-Fib Default priority Prompt Prompt Note: When arrhythmia alarms occur, check the patients condition and the ECG connections. D.1.3 Resp Physiological Alarm Messages Alarm message Default priority Cause and solution Resp Aritifact Apnea High High The patients heartbeat has interfered with his respiration. Check the patients condition and the Resp connections. The respiration signal was so weak that the monitor cannot perform respiration analysis. Check the patients condition, module and patient connections. D.1.4 SpO2 Physiological Alarm Messages Alarm message Default priority Cause and solution SpO2 Desat High The SpO2 value falls below the desaturation alarm limit. Check the patients condition and check if the alarm limit settings are correct. D.1.5 PR Physiological Alarm Messages Alarm message Default priority Cause and solution No Pulse High The pulse signal was so weak that the monitor cannot perform pulse analysis. Check the patients condition, SpO2 sensor and measurement site. D.1.6 NIBP Physiological Alarm Messages Alarm message Default priority Cause and solution NIBP-S/NIBP-D/NIBP-M Extremely High NIBP-S/NIBP-D/NIBP-M Extremely Low High High The NIBP value is higher than the NIBP Extreme alarm high limit. Check the patients condition and check if the alarm limit settings are correct. The NIBP value is lower than the NIBP Extreme alarm low limit. Check the patients condition and check if the alarm limit settings are correct. D.1.7 IBP Physiological Alarm Messages Alarm message Default priority Cause and solution Art-S/Art-D/Art-M Extremely High Art-S/Art-D/Art-M Extremely Low High High The Art value is higher than the Art Extreme alarm high limit. Check the patients condition and check if the alarm limit settings are correct. The Art value is lower than the Art Extreme alarm low limit. Check the patients condition and check if the alarm limit settings are correct. D - 2 D.1.8 CO2 Physiological Alarm Messages Alarm message Default priority Cause and solution FiO2 Shortage High FiO2 concentration is less than18%. Check the patients condition, the ventilated O2 content and the CO2 connection. D.1.9 AG Physiological Alarm Messages Alarm message Default priority Cause and solution FiO2 Shortage High Mixed Agent and MAC3 Med Apnea High Check the patients condition, the ventilated O2 content and the AG connections. The mixed anaesthetic gases concentration is too high. Adjust the anaesthetic gases concentration. The respiration signal was so weak that the monitor cannot perform respiration analysis. Check the patients condition, module and patient connections. D.1.10 EWS Physiological Alarm Messages Alarm message Default priority Cause and solution EWS Score High/Mediate The total score exceeds the configured alarm limit. Check the patient condition. XX score is 3 Mediate The parameter score is 3. Check the patient condition. XX represents RR, SpO2, Temp, BP-S, BP-D, BP-M, HR, EtCO2, FiO2. D.2 Technical Alarm Messages This section lists technical alarms, their default priority, indication on alarm reset, and the actions that can be taken when an alarm occurs. Technical alarms give different alarm indicators when the alarm system is reset. In this section we classify the technical alarms into three categories for easy clarification:
A: technical alarms are cleared. The monitor gives no alarm indications. B: technical alarms are changed to the prompt messages. C: the alarm is silenced and a appears before the alarm message, indicating that the alarm is acknowledged. In the following tables we will use A, B, and C to refer to the indications on alarm reset. D.2.1 General Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution XX Module Error High C XX module does not work properly. Replug the module, if the alarm persists, contact your service personnel. Note: XX represents a measurement or parameter label, such as HR, RR, SpO2, EtCO2, and so on. D - 3 D.2.2 ECG Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution ECG Noisy Low/Prompt ECG Amplitude Too Small Low ECG Lead Off ECG XX Lead Off High, Med, or Low, configurable High, Med, or Low, configurable ECG Signal Invalid Low ECG Learning Prompt Cannot Analyze QT Prompt A C B B A
/
/
The ECG signal is noisy. Check for any possible sources of signal noise around the cable and electrode, and check the patient for excessive motion. The ECG amplitude does not reach the detected threshold. Check for any possible source of interference around the cable and electrode. The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable. Check the connections of the electrodes and leadwires. The electrode has become detached from the patient or the lead wire has become disconnected from the adapter cable. Check the connections of the electrodes and leadwires. Patient skin impedance is too high. Check ECG electrode application. ECG learning is manually or automatically triggered.
/
Note: XX represents ECG lead name, for example RL, LL, V, Va, Vb, and so on. D.2.3 Resp Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Resp Interference Prompt Electrode Poor Contact Prompt
/
/
The respiration circuit is disturbed. Check for any possible sources of signal noise. Check the electrode application. Reposition or replace the electrodes if necessary. D.2.4 SpO2 Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution SpO2 Sensor Off Adjustable SpO2 No Sensor Low SpO2 Excess Light Low B A C The SpO2 sensor has become detached from the patient or the module. Check the sensor connection. If the alarm persists, replace the sensor. The SpO2 extension cable is detached from the SpO2 module, or the SpO2 sensor is detached from the SpO2 extension cable. Check the SpO2 cable and the sensor connection. If the alarm persists, replace the sensor. Ambient light is too strong. Move the sensor to a place with lower level of ambient light or cover the sensor to minimize the ambient light. D - 4 Alarm message Default priority Indication on alarm reset Cause and solution SpO2 No Pulse Low SpO2 Sensor Incompatible Low SpO2 Low Signal Quality Low SpO2 Interference Low SpO2 Sensor Error SpO2 Searching Pulse SpO2 Low Perfusion Low Prompt Prompt C C C C C
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The SpO2 sensor failed to obtain pulse signal. Check the patients condition and replace the sensor application site. If the alarm persists, replace the sensor. Incompatible or an unspecified SpO2 sensor is used. Use specified sensors. 1. Check the sensor and sensor position. 2. Make sure the patient is not shivering or moving. 3. The patients pulse may be too low to be measured. The SpO2 signal has been interfered. Check for any possible sources of signal noise and check the patient for excessive motion. Replace the sensor and measure again. SpO2 is searching for pulse. The SpO2 sensor is not properly placed or the patients perfusion index is too low. 1. Check the sensor and sensor position. 2. Reposition the sensor if necessary. D.2.5 Temp Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution T XX Sensor Off Low A Check the sensor connection and reconnect the sensor. Note: XX represents a temperature site, for example skin, core, axil, T1, and so on. D.2.6 NIBP Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution NIBP Cuff Loose Low NIBP Cuff or Airway Leak NIBP Airway Error NIBP Weak Signal NIBP Overrange Low Low Low Low NIBP Excessive Motion Low A A A A A A There is a leak in the cuff or air tubing. Use a cuff of correct type based on the patient size. Apply the cuff and connect the air tubing as instructed in the manual. Check the NIBP cuff and pump for leakages. The air tubing may be occluded. Check the air tubing for an occlusion or kinking. If the alarm persists, contact your service personnel. The patients pulse is weak or the cuff is loose. Check the patients condition and replace the cuff application site. The measured NIBP value exceeds the module measurement range. Check the patients condition. Check the patients condition and reduce patient motion. D - 5 Alarm message Default priority Indication on alarm reset Cause and solution NIBP Cuff Overpressure Low NIBP Timeout Low NIBP Cuff and Patient Mismatch Low NIBP Airway Leak Low A A A A The NIBP airway may be occluded. Check the airway and measure again. If the alarm persists, contact your service personnel. The measurement time exceeds 120 seconds in the adult or pediatric mode, or exceeds 90 seconds in the neonatal mode, and the BP value cannot be obtained. Check the patients condition and NIBP connections, or replace the cuff and measure again. The cuff type mismatches the patient category. Verify the patient category or replace the cuff if necessary. If patient catergory is correct, check that the tubing is not bent and the airway is not occluded. Airway leakage is found during the NIBP leakage test. Check the NIBP cuff and pump for leakages. D.2.7 IBP Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution XX Sensor Error Med XX No Sensor XX No Pulse XX Disconnected High, Med, or Low, configurable Low High C A A C The IBP sensor fails. Replace the sensor. The IBP patient cable and/or corresponding IBP sensor is not connected or detached. Check the cable and sensor connection. The catheter may be occluded. Please flush the catheter. The liquid way is disconnected from the patient, or the three-way valve is open to the air. Check the connection of the liquid way, or check the valve is open to the patient. If the alarm persists, contact your service personnel. Note: XX represents an IBP label, for example PA, CVP, FAP, P1, and so on. D.2.8 C.O. Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution TB Sensor Off TI Sensor Off Low Low A A Check the sensor connection and reconnect the sensor. Check the sensor connection and reconnect the sensor. D - 6 D.2.9 CO2 Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution CO2 Module High Temp Low CO2 Module Low Temp Low CO2 Zero Failed Low CO2 No Watertrap CO2 High Airway Pressure Low Low CO2 Low Airway Pressure Low CO2 High Barometric Low CO2 Low Barometric Low C C C B C C C C Ambient temperature is too high or there is a module failure. 1. Lower the operating temperature. 2. Replug the module. 3. If the alarm persists, the CO2 module may fail, contact your service personnel. Ambient temperature is too low or there is a module failure. 1. Raise the operating temperature. 2. Replug the module. 3. If the alarm persists, the CO2 module may fail, contact your service personnel. For mainstream CO2 module, check the connections between the adapter and CO2 transducer. Wait till the sensors temperature becomes stabilized, and then perform a zero calibration again. For sidestream CO2 module, replug the module. If the alarm persists, contact your service personnel. Check the watertrap connections. 1. Check the airway pressure settings of the ventilator/anesthesia machine. 2. Disconnect the module from the ventilator/
anesthesia machine. 3. Replug the module. 4. If the alarm persists, contact your service personnel. 1. Check the airway pressure settings of the ventilator/anesthesia machine. 2. Disconnect the module from the ventilator/
anesthesia machine. 3. Replug the module. 4. If the alarm persists, contact your service personnel. The ambient pressure exceeds the operating pressure range or CO2 module fails. 1. Make sure that the ambient pressure meets the specifications, and check for sources that affect the ambient pressure. 2. Replug the module. 3. If the alarm persists, contact your service personnel. The ambient pressure exceeds the operating pressure range or CO2 module fails. 1. Make sure that the ambient pressure meets the specifications, and check for sources that affect the ambient pressure. 2. Replug the module. 3. If the alarm persists, contact your service personnel. D - 7 Alarm message Default priority Indication on alarm reset Cause and solution CO2 Airway Occluded Low CO2 No Filterline CO2 Calibration Required CO2 Airway Error CO2 Adapter Error CO2 No Sensor CO2: Change Watertrap CO2 Watertrap and Patient Mismatch CO2: Change O2 Cell Low Low Low Low Low Low Low Low C A C C A A C C C 1. Check if the sample line is kinked or occluded. 2. Replace the sample line. 3. Replug the module. 4. If the alarm persists, contact your service personnel. Make sure that the filterline is connected. Perform a calibration. 1. Check if the sample line is kinked or occluded. 2. Replace the sample line. 3. Replug the module. 4. If the alarm persists, contact your service personnel. Check, clean or replace the airway adapter. Perform a zero calibration. Make sure that the CO2 transducer is connected. Replace the watertrap. Check the patient category and use a correct watertrap. The oxygen sesnor is depleted or fails. Replace the oxygen sensor. D.2.10 AG Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution AG No Watertrap AG: Change Watertrap AG Watertrap and Patient Mismatch AG Zero Failed Low Low Low Low Anesthetic Mixture AG Airway Occluded Low Low B C C C C C Check the connections of the watertrap and re-
connect it. Replace the watertrap. Check the patient category and use a correct watertrap. There is external electromagnetic interference, airway occlusion or module failure. 1. Check for external inference sources. 2. Check for AG Airway Occluded alarm message. Remove the occlusion. 3. If the alarm persists, contact your service personnel. Anesthetic mixture is detected. 1. Check if the sample line is occluded. 2. Check the sample line. 3. Replug the module. 4. If the alarm persists, contact your service personnel. Note: XX represents BIS label, for example G, C, LE, LT, RL-RA, L-R, F-R, 1, 2, and so on. D - 8 D.2.11 EWS Technical Alarms Alarm message Default priority Indication on alarm reset Cause and solution EWS param XX is timeout Low EWS score needs to be confirmed Low A A The manually input parameter is timeout. Input a parameter numeric again. Confirm to save or give up current score. XX represents RR, SpO2, Supp. O2, Temp, BP, HR, Consciousness, Blood Sugar, Urine Output, Catheter, Pain Score, Pain, EtCO2, FiO2, Airway, or Customer defined parameter. D.2.12 Power Supply Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Low Battery Med Critically Low Battery High Power Board Comm Error High Battery Error RT Clock Need Reset RT Clock Not Exist XX V Too High XX V Too Low High High High High High C C C C C C C C Connect the monitor to the external power supply and allow the batteries to charge. Connect the monitor to the external power supply and allow the batteries to charge. Restart the monitor. If the alarm persists, contact your service personnel. The battery may fail. Contact your service personnel. Contact your service personnel. Contact your service personnel. There is a problem with the system power supply. Restart the monitor. Note: XX represents 2.5 V, 3.3 V,5 V, or 12 V. D.2.13 Recorder Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Recorder Init Error Low Recorder Comm Error Recorder Head Hot Low Low Recorder Initializing Recorder out of Paper Prompt Prompt Recorder Busy Prompt A A C
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An error occurred during the recorder initialization. If the alarm persists, contact your service personnel. Restart the monitor if not solved. If the alarm persists, contact your service personnel. The recorder has been working for too long time. Stop the recording and resume the recording till the recorders print head cools down. Wait until the recorder initialization is completed. The recorder paper is not loaded or the recorder door is not closed. Check the recorder, load the recorder paper or close the recorder door. The buffer queue for recording is full. D - 9 D.2.14 Printer Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Printer Buffer Full Prompt Fail Printing Stopped Printer Unavailable PDF storage space is nearly full Prompt Prompt Prompt Prompt Error storing PDF file Prompt Change the print server language to be consistent with this monitor Prompt Print Server Disconnected Prompt
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The printer buffer is full. Wait till the printer finishes the printing task. The printer runs out of paper or cannot be connected. Check the printer. Printing is manually stopped. The printer may fail. Check the printer. Delete the files saved under the PDF file path to release storage space. Otherwise you cannot save new PDF files. The PDF file path settings on the printer server and the PDFCreator are not consistent or the PDF storage space is full. Check the PDF file path settings for consistency, or delete the files saved under the PDF file path to release storage space. Verify that the language settings of the printer server and the monitor are consistent, Otherwise you cannot perform printing. Check that the monitor is properly connected with the printer server. D.2.15 Technical Alarm Messages Related to Networked Monitoring Alarm message Default priority Indication on alarm reset Cause and solution No CMS View Bed XX YY-ZZ, Network Disconnected. Viewed by Bed XX YY-ZZ, Network Disconnected. Low Low Low WLAN IP Address Conflict Low LAN1 IP Address Conflict Low Fail To Get WLAN IP Address Fail To Get LAN1 IP Address Low Low B A A C C C C The monitor is disconnected from the CMS. Check the network connection. The network is interrupted when the monitor is viewing the remote device. Check the network connection. The network is interrupted when the monitor is viewed by another remote device. Check the network connection. Wireless network IP network conflicts. Check the network settings. Wired network LAN1 IP network conflicts. Check the network settings. Unable to automatically obtain the wireless network IP address. Check the network settings. Unable to automatically obtain the wired network LAN1 IP address. Check the network settings. Note: XX refers to the department name, YY refers to the room number, and ZZ refers to the bed number. D - 10 D.2.16 Other System Technical Alarm Messages Alarm message Default priority Indication on alarm reset Cause and solution Storage Card Error High Loading Default Config Failed Low Prompt Prompt Prompt XX Conflicts
(XX refers to the module label) XXX Measurement has been closed
(XX refers to the module label) The display setup for XXX is disabled.
(XX refers to the parameter label) The patient data storage space is nearly full. Please delete some discharged patients. C A
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The storage card fails or files are damaged. Restart the monitor to format the storage card. If the alarm persists, contact your service personnel. The default configuration is not correctly loaded. The monitor will restore to the factory default configuration for the current patient category. The same type of corresponding module being used exceeds the supported number. Remove the conflict module. The parameter module is disabled. Switch on the module if you want to use it. For more information, see 3.11.1Switching On or Off a Parameter. The parameter of the newly inserted module is not displayed on the screen. Select a desired area to display the parameter numerics and waveforms. For more information, see 25.11The Other Settings. Configurable B Delete unnecessary earlier discharged patient. D - 11 E SpO2 Sensor Accuracy E.1 The Accuracy of Masimo SpO2 Sensors Table information for the plots below show ARMS values measured with Masimo SET Oximetry Technology in a clinical study. Adtx/Pdtx/4000/4001 Inf/Neo/NeoPt/4002/4003/4004/4005 E - 1 DCI/DCIP/4050/4051 LNCS YI 4053 E - 2 E.2 The Accuracy of Nellcor SpO2 Sensors SpO2 Accuracy for Nellcor Sensors vs. Co-Oximeters (Arms) SpO2 Range DS-100A D-YS, OXI-P/I, OXI-A/N MAXAI, MAXPI, MAXII MAXNI 100% to 70%
100% to 90%
90% to 80%
80% to 70%
1.64%
2.41%
1.62%
1.85%
1.16%
1.38%
1.49%
1.71%
1.67%
2.50%
1.57%
1.51%
2.25%
3.60%
2.50%
1.59%
Modified Bland-Altman for SpO2 - MAXAI, MAXPI, MAXII, MAXNI Sensors: (SpO2 - SaO2) vs.SaO2 Modified Bland-Altman for SpO2 - DS-100A Sensors: (SpO2 - SaO2) vs.SaO2 E - 3 Modified Bland-Altman for SpO2 - D-YS, OXI-A/N, OXI-P/I Sensors: (SpO2 - SaO2) vs.SaO2 E - 4 F Units, Symbols and Abbreviations F.1 Units Abbreviation A V s A Ah bpm bps C cc cm dB DS F g GHz GTT h Hz in k kg kPa L lb m mAh mcg mEq mg min ml mm In Full microampere microvolt microsecond Ampere Ampere hour beat per minute bits per second Celsius cubic centimeter centimeter decibel dyne second Fahrenheit gram gigahertz gutta hour hertz inch kilo kilogram kilopascal litre pound meter milliampere hour microgram milli-equivalents milligram minute milliliter millimeter mmHg millimeters of mercury F - 1 In Full centimeters of water millisecond millivolt milliwatt megaohm nanometer breaths per minute second volt volt ampere ohm watt Explanation negative, minus percent per; divide; or to plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright Abbreviation cmH2O ms mV mW M nm rpm s V VA W F.2 Symbols Symbol
%
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F - 2 F.3 Abbreviations Abbreviation AaDO2 In Full alveolar-arterial oxygen gradient AC ACI Adu AG AHA Ao Art ATMP AUC Avg aVF aVL aVR awRR BAP BC BL BoA BSA BT BTPS CAA CaO2 CCF CCI CCO CCU CE CFI C.I. CIS CISPR CMOS CMS C.O. CO2 alternating current acceleration index adult anaesthesia gas American Heart Association aortic pressure arterial barometric pressure area under the curve rSO2 average left foot augmented lead left arm augmented lead right arm augmented lead airway respiratory rate brachial arterial pressure burst count baseline Balance of Anesthesia body surface area blood temperature body temperature and pressure, saturated Clinical Assistive Application arterial oxygen content CPR quality index continuous cardiac index continuous cardiac output cardiac (coronary) care unit Conformit Europenne cardiac function index cardiac index clinical information system International Special Committee on Radio Interference complementary metal oxide semiconductor central monitoring system cardiac output carbon dioxide F - 3 Abbreviation In Full COHb Compl COPD CPI CQI CPO CVP DC Des Dia dpi dPmx DVI DO2 DO2I ECG EDV EE EEC EEG EMC EMG EMI Enf ESV ESVI ESU Et EtAA EtDes EtEnf EtHal EtIso EtSev EtCO2 EtN2O EtO EtO2 EVLW F - 4 carboxyhemoglobin compliance chronic obstructive pulmonary disease cardiac power index CPR quality index cardiac power output central venous pressure direct current desflurane diastolic dot per inch left ventricular contractility digital video interface oxygen delivery oxygen delivery index electrocardiograph end-diastolic volume energy expenditure European Economic Community electroencephalogram electromagnetic compatibility electromyograph electromagnetic interference enflurane end systolic volume end systolic volume index electrosurgical unit end-tidal end-tidal anesthetic agent end-tidal anesthetic agent end-tidal carbon dioxide end-tidal nitrous oxide ethylene oxide end-tidal oxygen extravascular lung water Abbreviation In Full ELWI EWS FAP FCC FDA Fi FiAA FiDes FiEnf FiHal FiIso FiSev FiCO2 FiN2O FiO2 FPGA FV GCS GEDV GEDI GEF Hal Hb Hct HIS HR IBP IBW ICG ICP ICT/B ICU ID I:E IEC IEEE IP Iso ITBI extravascular lung water index Early Warning Score femoral arterial pressure Federal Communication Commission Food and Drug Administration fraction of inspired inspired anesthetic agent inspired anesthetic agent fraction of inspired carbon oxygen fraction of inspired nitrous oxide fraction of inspired oxygen field programmable gate array flow-volume Glasgow Coma Scale global end diastolic volume global end diastolic volume index global ejection fraction halothane hemoglobin haematocrit hospital information system heart rate invasive blood pressure ideal body weight impedance cardiography intracranial pressure intracranial catheter tip pressure transducer intensive care unit identification inspiratory time: expiratory time ratio International Electrotechnical Commission Institute of Electrical and Electronic Engineers internet protocol isoflurane intrathoracic blood volume index F - 5 Abbreviation In Full ITBV LA LAP LCD LCW LCWI LDAP LED LL LVET LVSW LVSWI MAC MAP Mb MetHb MEWS MLDAP MRI MV MVe MVi N/A N2 N2O Neo NEWS NIBP NIF O2 O2%
OR OxyCRG PA Paw PAWP pCVP Ped PEEP F - 6 intrathoracic blood volume left arm left atrial pressure liquid crystal display left cardiac work left cardiac work index Lightweight Directory Access Protocol light emitting diode left leg left ventricular ejection time left ventricular stroke work left ventricular stroke work index minimum alveolar concentration mean arterial pressure myoglobin methemoglobin Modified Early Warning Score Mindray LDAP, Mindray lightweight directory access protocol magnetic resonance imaging minute volume expiratory minute volume inspiratory minute volume not applied nitrogen nitrous oxide neonate National Early Warning Score noninvasive blood pressure negative inspiratory force oxygen oxygen concentration operating room oxygen cardio-respirogram pulmonary artery airway pressure pulmonary artery wedge pressure central venous pressure pediatric positive end expiratory pressure Abbreviation In Full PEF PEP PIF PIP Pleth Pmean PO2 Pplat PPV PR PVC PVPI PVR PVRI qSOFA RA RAP Raw Rec Resp RL RM RQ RR RSBI RVEF rSO2 SaO2 ScvO2 SEF Sev SI SlopeCO2 SMR SOFA SpO2 SQI SR SSC peak expiratory flow pre-ejection period peak inspiratory flow peak inspiratory pressure plethysmogram mean pressure oxygen supply pressure plateau pressure pulse pressure variation pulse rate premature ventricular contraction pulmonary vascular permeability index pulmonary vascular resistance pulmonary vascular resistance index quick Sepsis-Related Organ Failure Assessment right arm right atrial pressure airway resistance record, recording respiration right leg respiratory mechanics respiratory quotient respiration rate rapid shallow breathing index right ventricular ejection fraction regional oxygen saturation arterial oxygen saturation central venous oxygen saturation spectral edge frequency sevoflurane stroke index Slope of the alveolar plateau satellite module rack Sepsis-Related Organ Failure Assessment arterial oxygen saturation from pulse oximetry signal quality index suppression ratio Surviving Sepsis Campaign F - 7 Abbreviation In Full SSI STR SV SVI SVR SVRI SVV SvO2 Sync Sys TB tcpCO2 tcpO2 TD Temp TFC TFI TFT TI TP TRC TVe TVi TV UAP UPS USB UVP VAC VCO2 Vdaw Vdaw/Vt Vdalv Vdalv/Vt Vdphy Vd/Vt VEPT VI VO2 F - 8 signal strength index systolic time ratio stroke volume stroke volume index systemic vascular resistance systemic vascular resistance index stroke volume variation venous oxygen saturation synchronization systolic pressure blood temperature transcutaneous carbon dioxide partial pressures transcutaneous oxygen partial pressures temperature difference temperature thoracic fluid content thoracic fluid index thin-film technology injectate temperature total power tube resistance compensation expiratory tidal volume inspiratory tidal volume tidal volume umbilical arterial pressure uninterruptible power supply universal serial bus umbilical venous pressure volts alternating current CO2 production for one breath airway dead space airway dead space to tidal volume ratio alveolar dead space alveolar dead space to tidal volume ratio physiologic dead space dead space to tidal volume ratio volume of electrically participating tissue velocity index O2 consumption for one breath Abbreviation In Full VO2I VPB WOB oxygen consumption index ventricular premature beat per minute work of breathing F - 9 Caution:
This device complies with Part 15 of the FCC rules and Industry Canada licenseexempt RSS standard(s).Operationissubjecttothefollowingtwoconditions:(1)thisdevicemaynotcause harmful interference, and (2) this device must accept any interference received, including interferencethatmaycauseundesiredoperation. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modificationsorchangetothisequipment.Suchmodificationsorchangecouldvoidtheusers authoritytooperatetheequipment. Thisradiotransmitter(identifythedevicebycertificationnumberormodelnumberifCategoryII) hasbeenapprovedbyIndustryCanadatooperatewiththeantennatypeslistedbelowwiththe maximumpermissiblegainindicated.Antennatypesnotincludedinthislist,havingagaingreater thanthemaximumgainindicatedforthattype,arestrictlyprohibitedforusewiththisdevice. ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice, pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotection againstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,usesandcan radiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions, maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethat interference will not occur in a particular installation. If this equipment does cause harmful interferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipment off and on, the user is encouraged to try to correct the interference by one or more of the followingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiveris connected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. ThedevicehasbeenevaluatedtomeetgeneralRFexposurerequirement. To maintain compliance with FCCs RF exposure guidelines, this equipment should be installedandoperatedwithaminimumdistanceof20cmbetweentheradiatorandyour body. 5G For 5150-5250, 5250-5350, 5470-5725 and 5725-5850 frequency band, Operations in the 5150-5250, 5250-5350, 5470-5725 and 5725-5850 band are restricted to indoor usage only. 5G:
Any emission is maintained within the band of operation under all conditions of normal operation. The max. frequency stability is less than 20ppm. Caution:
This device complies with Part 15 of the FCC rules and Industry Canada licenseexempt RSS standard(s).Operationissubjecttothefollowingtwoconditions:(1)thisdevicemaynotcause harmful interference, and (2) this device must accept any interference received, including interferencethatmaycauseundesiredoperation. The manufacturer is not responsible for any radio or TV interference caused by unauthorized modificationsorchangetothisequipment.Suchmodificationsorchangecouldvoidtheusers authoritytooperatetheequipment. Thisradiotransmitter(identifythedevicebycertificationnumberormodelnumberifCategoryII) hasbeenapprovedbyIndustryCanadatooperatewiththeantennatypeslistedbelowwiththe maximumpermissiblegainindicated.Antennatypesnotincludedinthislist,havingagaingreater thanthemaximumgainindicatedforthattype,arestrictlyprohibitedforusewiththisdevice. ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice, pursuanttopart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotection againstharmfulinterferenceinaresidentialinstallation.Thisequipmentgenerates,usesandcan radiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions, maycauseharmfulinterferencetoradiocommunications.However,thereisnoguaranteethat interference will not occur in a particular installation. If this equipment does cause harmful interferencetoradioortelevisionreception,whichcanbedeterminedbyturningtheequipment off and on, the user is encouraged to try to correct the interference by one or more of the followingmeasures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthereceiveris connected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. ThedevicehasbeenevaluatedtomeetgeneralRFexposurerequirement. To maintain compliance with FCCs RF exposure guidelines, this equipment should be installedandoperatedwithaminimumdistanceof20cmbetweentheradiatorandyour body. 5G For 5150-5250, 5250-5350, 5470-5725 and 5725-5850 frequency band, Operations in the 5150-5250, 5250-5350, 5470-5725 and 5725-5850 band are restricted to indoor usage only. 5G:
Any emission is maintained within the band of operation under all conditions of normal operation. The max. frequency stability is less than 20ppm.
1 2 | label | ID Label/Location Info | 692.49 KiB |
nal n d lA ay Patent: http://www.mindrayna.com/patents Patient Monitor for Masimo patents: http://www.masimo.com/patents.htm for Covidien patents: http://www.covidien.com/patents 100-240V~ 50/60Hz 2.0-0.9A Manufactured in China by Shenzhen Mindray Bio-Medical Electronics Co.,LTD. Mindray Building, Keji 12th Road South,High-Tech Ind, Shenzhen, China Distributed by Mindray DS USA, Inc. EU VETe Ua d MME OZ: SLUM. 047-028819-00(1.0)
1 2 | FCC justification letter | Cover Letter(s) | 11.69 KiB |
Shenzhen Mindray BIO-Medical electronics Co.,LTD. Date: 5/15/2019 To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD To Whom It May Concern:
We, Shenzhen Mindray BIO-Medical electronics Co.,LTD., state that our device, FCC ID: ZLZ-EPM, has a non-detachable battery, the label is visible to the users as they purchase the products and install TF card or SIM cards. The back cover can not be moved away, so the FCC ID label has to be placed on the surface of product. Sincerely, Signature
[Leo Shao (Name)]
[Manager(Title)]
[Shenzhen Mindray BIO-Medical electronics Co.,LTD. (Company name)]
1 2 | confidentiality request letter | Cover Letter(s) | 13.75 KiB |
Shenzhen Mindray BIO-Medical electronics Co.,LTD. Date: May 15, 2019 File Name Schematics.pdf Block Diagram.pdf Operational Description.pdf Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: ZLZ-EPM Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:
Exhibit Type Schematics Block Diagram Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Shenzhen Mindray BIO-Medical electronics Co.,LTD. Signature Leo Shao / Manager Typed name and Title
1 2 | model difference statement | Cover Letter(s) | 30.97 KiB |
Shenzhen Mindray BIO-Medical electronics Co.,LTD. Date: 5/15/2019 Subject: authorization for adding family models To whom it May concern, Statement We would like to confirm the product Patient Monitor with models ePM 15M, ePM 12M, ePM 10M, ePM 15, ePM 12, ePM 10 are same in all respects. Only the model names and size of display screen are different for different market requirement. Yours sincerely,
[signature]
[Leo Shao]
[Manager]
[Shenzhen Mindray BIO-Medical electronics Co.,LTD.]
1 2 | Power of Attorney Letter | Cover Letter(s) | 13.10 KiB |
Shenzhen Mindray BIO-Medical electronics Co.,LTD. FCC ID: ZLZ-EPM POWER OF ATTORNEY Date: May 15, 2019 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 To Whom It May Concern:
We, the undersigned, hereby authorize Waltek Services (ShenZhen) Co., Ltd.
(Philo Zhong) on our behalf, to apply to the Federal Communications Commission on our equipment. Any and all acts carried out by Waltek Services (ShenZhen) Co., Ltd. (Philo Zhong) on our behalf shall have the same effect as acts of our own. This authorization expires on May 14, 2020. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. We, Shenzhen Mindray BIO-Medical electronics Co.,LTD. are not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 USC853a, and no party to the application is subject to a denial of federal benefits pursuant to that section. Sincerely, Shenzhen Mindray BIO-Medical electronics Co.,LTD. Signature Leo Shao / Manager Typed name and Title
frequency | equipment class | purpose | ||
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1 | 2019-05-28 | 5470 ~ 5725 | NII - Unlicensed National Information Infrastructure TX | Original Equipment |
2 | 2412 ~ 2462 | DTS - Digital Transmission System |
app s | Applicant Information | |||||
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1 2 | Effective |
2019-05-28
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1 2 | Applicant's complete, legal business name |
Shenzhen Mindray BIO-Medical electronics Co.,LTD.
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1 2 | FCC Registration Number (FRN) |
0020888061
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1 2 | Physical Address |
Mindray Building,Keji 12th Road South,Hi-tech Ind
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1 2 |
Shenzhen
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1 2 |
China
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
T******@TIMCOENGR.COM
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1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
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app s | FCC ID | |||||
1 2 | Grantee Code |
ZLZ
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1 2 | Equipment Product Code |
EPM
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
l**** S****
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1 2 | Telephone Number |
86-75********
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1 2 | Fax Number |
86-75********
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1 2 |
l******@mindray.com
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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 | NII - Unlicensed National Information Infrastructure TX | ||||
1 2 | DTS - Digital Transmission System | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Patient Monitor | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original 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 | Power listed is conducted. This is an indoor professional product with the internal antenna which must be installed to provide a separation distance of at least 20cm from all persons and must not transmit simultaneously with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Users must be provided with installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
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 |
Waltek Services (Shenzhen) Co., Ltd
|
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1 2 | Name |
P****** Z********
|
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1 2 | Telephone Number |
+86-7********
|
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1 2 |
P******@waltek.com.cn
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15E | CC | 5150 | 5250 | 0.082 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15E | CC | 5250 | 5350 | 0.0718 | |||||||||||||||||||||||||||||||||||
1 | 3 | 15E | CC | 5470 | 5725 | 0.06 | |||||||||||||||||||||||||||||||||||
1 | 4 | 15E | CC | 5725 | 5850 | 0.0951 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 2412.00000000 | 2462.00000000 | 0.0810000 |
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