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IntelliVue MX40 Installation and Service Release C.01x This document contains proprietary information, which is protected by copyright. Notice Proprietary Information Second Edition May 2022 Document Number 4535 649 35151 Copyright Copyright 2022 Koninklijke Philips N.V. All rights reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any products at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. This product contains software licensed under an open source license. For acknowledgments, license texts and source code, please refer to the accompanying the IntelliVue MX40 Documentation CD. EASI is a trademark of Zymed Inc. Masimo and Masimo SET are federally registered trademarks of the Masimo Corporation. OxiCliq and OxiMax are registered trademarks of Nellcor Incorporated. Duracell is a registered trademark of Procter & Gamble Incorporated. STERRAD is a registered trademark of Advanced Sterilization Products. Tone modulation is licensed under US patent 4,653,498 from Nellcor Puritan Bennett Incorporated. Manufacturer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 USA www.healthcare.philips.com Printed in USA i Document Number 4535 649 35151 Warranty The information contained in this document is subject to change without notice. Philips Medical Systems makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. FCC The 865350 device complies with Part 95 sub-part H of the FCC Rules. Operation of 865350 equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. This device complies with part 95 of the FCC rules. The 865351 and 865352 devices comply with Part 15 of the FCC Rules only. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Changes and modifications not expressly approved by Philips Medical Systems can void your authority to operate this equipment under Federal Communications Commission's rules Protecting Personal Information It is recommended that customers have policies and procedures for the proper handling of personal or sensitive information, ePHI (electronic protected health information) and PHI (protected health information), which will maintain the confidentiality, integrity, and the availability of these types of data. Any organization using this product should implement the required protective means necessary to safeguard personal information consistent with each applicable country law, code and regulation; and consistent with their developed and maintained internal policies and procedures. While handling personal information is outside the scope of this document; in general, each organization is responsible for identifying:
Who has access to personal data and under what conditions an individual has authorization to use that data. What security controls are in place to protect personal and sensitive data. ii How the data is stored and the conditions by which it is stored. How the data is transmitted and the conditions under which that data is transmitted. Protecting personal health information is a primary component of a security strategy. Personal and sensitive information should be protected according to the applicable laws, regulations and directives, such as HIPAA, PIPEDA and/or Council of the European Union security and privacy rules. Compliance Uses of the system for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect operation, or modifications made to the system without explicit approval from Philips, may relieve the manufacturer (or his agent) from all or some responsibilities for resultant noncompliance, damage, or injury. Information Center Product Name As of Release C.02, the IntelliVue Information Center (also known as IIC iX) is called patient Information Center iX, or PIC iX. However, any references to IIC iX are considered equivalent to PIC iX. Printing History New editions of this document will incorporate all material updated since the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised. The documentation printing date and part number indicate its current edition. The printing date changes when a new edition is printed. (Minor corrections and updates which are incorporated at reprint do not cause the date to change.) The document part number changes when extensive technical changes are incorporated. Second Edition ........................................................................................... May 2022 iii Document Conventions In this guide:
Warnings Warning Cautions Caution Notes A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. A Caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. A Note contains additional information on the product's usage. iv Contents 1. Introduction 1-1 Network Connectivity ------------------------------------------------------------------ 1-2 Network Components ------------------------------------------------------------------ 1-3 2. Installation 2-1 MX40 Release C.01 Compatibility ------------------------------------------------- 2-2 Wireless Network Configuration ---------------------------------------------------- 2-3 Assigning an Equipment Label - IIC iX -------------------------------------------- 2-4 Assigning an Equipment Label - IIC ----------------------------------------------- 2-6 Assigning an Equipment Label IntelliVue Support Tool Mark 2 ---------- 2-7 Equipment Label Character Limitations ------------------------------------------- 2-8 Clinical Configuration ------------------------------------------------------------------ 2-9 Frequency Management and Channel Selection ----------------------------- 2-10 Frequency Management ------------------------------------------------------- 2-10 Channel Selection ---------------------------------------------------------------- 2-10 865350 - Channel Selection --------------------------------------------------- 2-10 1.4GHz Smart-hopping Channel Definition ----------------------------- 2-12 865350 - Short-range Radio (SRR) Channel Selection -------------- 2-14 SRR Channel Recommendations for 865350 Installations. -------- 2-15 865351 Channel Selection ----------------------------------------------------- 2-15 2.4 GHz Smart-hopping Channel Selection ----------------------------- 2-16 865351 - Short-range Radio (SRR) Channel Selection -------------- 2-16 Smart-hopping and SRR Channel Selection for 2.4GHz Smart-hopping Networks ----------------------------------------- 2-17 865352 - Channel Selection --------------------------------------------------- 2-26 865352 Short-range Radio (SRR) Channel Selection --------------- 2-26 SRR Channel Recommendations for 865352 Installations --------- 2-28 Short-range Radio Density ---------------------------------------------------- 2-28 3. Test and Inspection 3-1 MX40 Test & Inspection Matrix ----------------------------------------------------- 3-2 When to Perform Test Blocks ------------------------------------------------------- 3-4 4. Operating Modes 4-1 Monitoring Mode ------------------------------------------------------------------------ 4-2 Telemetry Mode Use -------------------------------------------------------------- 4-2 Monitor Mode Use ----------------------------------------------------------------- 4-2 Controls, Indicators and Connectors ------------------------------------------ 4-4 MX40 Controls and Indicators ------------------------------------------------ 4-4 Multi-Function Button ----------------------------------------------------------- 4-5 Silence/Acknowledge Alarm Button ----------------------------------------- 4-5 SmartKeys Button --------------------------------------------------------------- 4-5 Contents 1 Main Screen Button ------------------------------------------------------------- 4-5 SmartKeys ------------------------------------------------------------------------- 4-6 Alarms Area ----------------------------------------------------------------------- 4-7 Patient Information Area ------------------------------------------------------- 4-8 Paced Status ---------------------------------------------------------------------- 4-8 Display Lock ----------------------------------------------------------------------- 4-8 Status Area ------------------------------------------------------------------------ 4-8 Operating and Navigating -------------------------------------------------------- 4-9 Power-On Self Test -------------------------------------------------------------- 4-9 Touch Sensitive Display ------------------------------------------------------ 4-10 Navigating ------------------------------------------------------------------------ 4-10 Selecting Display Elements ------------------------------------------------- 4-10 Locking the Display ------------------------------------------------------------ 4-11 Display Auto-Lock -------------------------------------------------------------- 4-11 Measurement Area ------------------------------------------------------------ 4-11 Measurement Area Display Configurations ----------------------------- 4-11 Identifying the SpO2 Patient Cable Type -------------------------------- 4-12 Connecting/Disconnecting the Patient Cable --------------------------- 4-13 Changing Measurement Settings ------------------------------------------ 4-14 ECG Settings at the MX40 -------------------------------------------------- 4-14 Waveform Settings at the MX40 ------------------------------------------- 4-15 Battery Information --------------------------------------------------------------- 4-16 Battery Safety Information --------------------------------------------------- 4-16 Lithium-ion Rechargeable Battery Care ---------------------------------- 4-17 Lithium-ion Rechargeable Battery Storage ------------------------------ 4-18 Lithium-ion Rechargeable Battery Handling Precautions ----------- 4-18 Inserting/Removing Batteries ----------------------------------------------- 4-19 Inserting Batteries ---------------------------------------------------------------- 4-20 Removing the Batteries --------------------------------------------------------- 4-25 Battery Charge Status -------------------------------------------------------- 4-26 MX40 Performance at End of Battery Life ------------------------------- 4-27 Service Information Available in Monitoring Mode ---------------------- 4-28 Configuration Mode ------------------------------------------------------------------ 4-30 Clinical Configuration ------------------------------------------------------------ 4-30 Service Mode -------------------------------------------------------------------------- 4-33 Change Password ---------------------------------------------------------------- 4-33 Setup Network -------------------------------------------------------------------- 4-33 Revisions --------------------------------------------------------------------------- 4-33 Rechargeable Battery Information ------------------------------------------- 4-34 Demo Mode ---------------------------------------------------------------------------- 4-35 5. Maintenance 5-1 Cleaning ----------------------------------------------------------------------------------- 5-2 Cleaning Materials for the MX40 ----------------------------------------------- 5-4 2 Contents Unsupported Cleaners ------------------------------------------------------------ 5-6 Disposing of the MX40 ---------------------------------------------------------------- 5-7 Label Assignment for Replacement MX40 --------------------------------------- 5-8 Re-assigning an Equipment Label at the IntelliVue Information Center -------------------------------------------------- 5-8 Re-assigning an Equipment Label at the IntelliVue Information Center iX ----------------------------------------------- 5-9 Charging Lithium-ion Rechargeable Batteries -------------------------------- 5-10 Battery Power Indicators ------------------------------------------------------- 5-10 Charging Station LEDs ------------------------------------------------------- 5-11 Battery Status on the Charging Station Display ----------------------- 5-11 Battery Lifetime Management ------------------------------------------------- 5-12 Battery Disposal ------------------------------------------------------------------ 5-12 6. Part and Option Ordering Information 6-1 MX40 Support Parts ------------------------------------------------------------------- 6-2 7. MX40 Repair Strategy 7-1 Tools Required -------------------------------------------------------------------------- 7-2 Software License Transfer ----------------------------------------------------------- 7-3 8. Troubleshooting 8-1 Technical Alarms (INOPs) ------------------------------------------------------------ 8-2 Informational Messages ------------------------------------------------------------- 8-14 Additional Hardware Troubleshooting Information --------------------------- 8-16 Possible User Interface Issues ---------------------------------------------------- 8-22 Coverage Assessment -------------------------------------------------------------- 8-24 Assessment Mode --------------------------------------------------------------- 8-24 Link Quality Assessment Indicator Values ------------------------------ 8-25 Coverage Assessment Data ------------------------------------------------ 8-26 Data Format Smart-hopping Radio ------------------------------------- 8-27 Status Parameters ------------------------------------------------------------- 8-28 General Troubleshooting ----------------------------------------------------------- 8-31 WLAN Troubleshooting ------------------------------------------------------------- 8-32 9. MX40 WLAN (P/N 865352) 9-1 Short-range Radio and WLAN ------------------------------------------------------ 9-2 WLAN Configuration Parameters --------------------------------------------------- 9-3 WLAN Configuration Parameter Definitions --------------------------------- 9-5 MX40 WLAN Device Specific Performance Characteristics ----------------- 9-9 10. Safety Standards & Specifications 10-1 Regulatory Information -------------------------------------------------------------- 10-2 Software Hazard Prevention -------------------------------------------------- 10-2 AC Power Source ---------------------------------------------------------------- 10-2 Industrie Canada Compliance (Canada) ----------------------------------- 10-2 Contents 3 Safety Standards ----------------------------------------------------------------- 10-2 Intended Use Statement -------------------------------------------------------- 10-4 Indications for Use --------------------------------------------------------------- 10-4 Intended Uses of MX40 --------------------------------------------------------- 10-4 Authorized EU Representative ------------------------------------------------ 10-5 Authorized Australia Sponsor ------------------------------------------------- 10-5 Patient Population ---------------------------------------------------------------- 10-5 Rx ------------------------------------------------------------------------------------- 10-5 Contraindications ----------------------------------------------------------------- 10-5 Essential Performance ---------------------------------------------------------- 10-6 Risk Management Considerations ------------------------------------------- 10-6 Electromagnetic Compatibility ----------------------------------------------------- 10-9 Reducing Electromagnetic Interference ---------------------------------- 10-10 Restrictions for Use ------------------------------------------------------------ 10-10 Electromagnetic Compatibility (EMC) Specifications ----------------- 10-11 Accessories Compliant with EMC Standards ------------------------- 10-11 Electromagnetic Emissions -------------------------------------------------- 10-11 Electromagnetic Immunity --------------------------------------------------- 10-12 Recommended Separation Distance -------------------------------------- 10-12 Electrosurgery Interference/Defibrillation/Electrostatic Discharge --------------------------------------------------------------------- 10-14 Restart Time ------------------------------------------------------------------- 10-14 Battery Specifications -------------------------------------------------------------- 10-15 Lithium-ion Battery Charge Time ------------------------------------------- 10-18 Physical Specifications ------------------------------------------------------------ 10-19 MX40 1.4 GHz Smart-Hopping Radio ----------------------------------------- 10-20 MX40 2.4 GHz Smart-Hopping Radio ----------------------------------------- 10-21 MX40 Short-Range Radio -------------------------------------------------------- 10-22 MX40 2.4GHz WLAN Radio------------------------------------------------------ 10-23 FCC Radio Compliance------------------------------------------------------- 10-24 Industry Canada Radio Compliance--------------------------------------- 10-24 Environmental Specifications ---------------------------------------------------- 10-27 Measurement Specifications ----------------------------------------------------- 10-28 ECG -------------------------------------------------------------------------------- 10-28 ECG Performance Disclosure/Specifications --------------------------- 10-29 Distributed Alarm System Delay Specifications ------------------------ 10-30 Respiration ----------------------------------------------------------------------- 10-30 Respiration Alarm ------------------------------------------------------------ 10-30 FAST SpO2 ----------------------------------------------------------------------- 10-30 Masimo SET SpO2 ------------------------------------------------------------- 10-32 SpO2 Accuracy Specifications ---------------------------------------------- 10-32 4 Contents 1. Introduction The IntelliVue MX40 is a wearable patient monitor. It is designed to support ambulatory patients for continuous ECG and optionally, SpO2 and impedance respiration. The short-range radio option allows connection to the IntelliVue Cableless Measurements or an IntelliVue patient monitor for additional parameters. The display on the MX40 also provides immediate access to patient information at the point of care. Network Connectivity .............................................................................. 1-2 Network Components .............................................................................. 1-3 Introduction 1-1 Network Connectivity Network Connectivity The MX40 provides a choice of network connectivity options IntelliVue Smart-hopping or 802.11 a/b/g/n. Each device version can only operate on the specified network and maintains operation only on the approved RF frequencies for the device and network. The following table shows the MX40 version and associated network connectivity:
MX40 Version Supported Network Connectivity IntelliVue MX40 1.4 GHz Smart-hopping IntelliVue MX40 2.4 GHz Smart-hopping IntelliVue MX40 802.11 a/b/g/n 2.4 GHz or 5 GHz bands as part of Philips IntelliVue Clinical Network
(ICN) specification. Note For information about the WLAN version of the MX40 and its operation on customer supplied network infrastructure, see Chapter 9. 865350 865351 865352 1-2 Introduction Network Components Network Components The IntelliVue Smart-hopping wireless network is comprised of the following devices and components:
Introduction 1-3 2. Installation This section provides compatibility and configuration information for reference during MX40 installation. For clinical configuration information, see the MX40 Configuration Guide, p/n 4535 643 44071. MX40 Release C.01 Compatibility .......................................................... 2-2 Wireless Network Configuration ........................................................... 2-3 Assigning an Equipment Label - IIC iX ................................................. 2-4 Assigning an Equipment Label - IIC ...................................................... 2-6 Assigning an Equipment Label - IVST ................................................... 2-6 Equipment Label Character Limitations ............................................... 2-8 Clinical Configuration .............................................................................. 2-9 Frequency Management and Channel Selection ................................ 2-10 Installation 2-1 MX40 Release C.01 Compatibility MX40 Release C.01 Compatibility IntelliVue Information Center The MX40 (865350/865351) is compatible for use with IntelliVue Information Center Release N/N.01 only. Release L and M are not supported. The MX40 (865352) is not compatible with IntelliVue Information Center Release N or earlier. Patient Information Center iX The MX40 (865350/865351/865352) with ECG only or optional FAST SpO2 remains compatible with IntelliVue Information Center iX Release A.02.08 or latest release. The MX40 (865350/865351/865352) with optional Masimo SET technology is compatible for use with IntelliVue Information Center iX Release B.02.15 or latest release. Note 865350 and 865351 Smart-hopping devices operate on Smart-hopping Network infrastructure only. 865352 WLAN devices operate on 802.11 wireless network infrastructure only. MX40 Short-range Radio The MX40 (865350/865351) is compatible for use with IntelliVue Patient Monitors Release G or latest release when wirelessly connected via Short-range radio. The MX40 (865352) is compatible for use with IntelliVue Patient Monitors Release J or latest release when wirelessly connected via Short-range radio. The MX40 is compatible for use with IntelliVue Cableless Measurements Release C.0 or latest release. MX40 and Smart-hopping Infrastructure The MX40 (865350/865351) is compatible for use with Access Point Controller 862147, Release B.00.19 or latest release and Access Point Controller 865346, Release C.00.04 or latest release. MX40 Patient Cable The MX40 Patient Cables are compatible for use with the X2, X3, MMS, and MMX IntelliVue Patient Monitor platforms. 2-2 Installation Wireless Network Configuration Wireless Network Configuration MX40 865350 and 865351 (Smart-hopping) For the Smart-hopping MX40s (865350, 865351), wireless network configuration happens as a part of the equipment label assignment procedure. The MX40s are shipped from the factory with an Equipment Label of "NEW_DEVICE" and an RF Access Code of "0". This allows basic wireless connectivity to any Smart-hopping Access Point. After the MX40 has basic connectivity to the Smart-hopping network, the "Label Assignment" procedure can be performed at the Information Center. The
"Label Assignment" procedure configures the RF Access Code and Equipment Label into the MX40 without the need for any additional tools. MX40 865352 (802.11 a/b/g/n) For the 802.11 a/b/g/n MX40s (865352), wireless network configuration must be completed before the equipment label assignment procedure can be performed. The WLAN configuration is done using the IntelliVue Support Tool Mark2. See Chapter 9 of this document and also the IntelliVue Support Tool Instructions for Use for details. Installation 2-3 Assigning an Equipment Label - IIC iX Assigning an Equipment Label - IIC iX To assign an equipment label to a device:
1. Insert battery power into the MX40 and if attached, disconnect the patient cable. 2. Confirm the connection to the wireless network as follows:
3. Go to Manage Equipment > Label Assignment. The Assign Devices to Equipment Labels dialog window opens. 2-4 Installation Assigning an Equipment Label - IIC iX 4. Click the desired label in the Available Labels list, then click the desired Unassigned Device. 5. Click the Assign button. 6. When prompted, press Confirm on the MX40 to accept the assignment. 7. On the MX40, wait for the New_Device label to change to the selected 8. Confirm the label assignment by viewing the waveform in the Patient Sector at equipment label. the Information Center iX. Installation 2-5 Assigning an Equipment Label - IIC Assigning an Equipment Label - IIC To assign an equipment label to a device:
1. Select All Controls > Label Assignment. 2. Enter password (tele) 3. Insert battery power into the MX40 and if attached, disconnect the patient cable. 4. Select Refresh. 5. Confirm the connection to the wireless network as follows:
6. Select the MAC address of the device from the New Devices list. If the address does not appear, remove battery power and re-insert. Select Refresh. Note The MAC address appears on the rear label of the MX40. 7. Select the desired equipment label from the Equipment Label list. 8. Select Assign Label to initiate programming of the equipment label and RF Access Code into the MX40. 9. When prompted, press Confirm on the MX40 to accept the assignment. The confirmation must occur within 30 seconds of the prompt. 10. On the MX40, wait for the New_Device label to change to the selected equipment label. 11. Confirm the label assignment by viewing the waveform in the Patient Sector at the Information Center. 2-6 Installation Assigning an Equipment Label IntelliVue Support Tool Mark 2 Assigning an Equipment Label IntelliVue Support Tool Mark 2 Equipment labels may also be assigned using the IntelliVue Support Tool Mark 2. For Smart-hopping devices, the RF Access Code may also be configured using the IntelliVue Support Tool Mark 2. Installation 2-7 Equipment Label Character Limitations Equipment Label Character Limitations Equipment labels are limited to a maximum of 10 bytes. If the equipment label exceeds the 10 byte maximum, the label assignment process will fail. UTF-8 encoded characters may use 1-4 bytes depending on the language.
(http://en.wikipedia.org/wiki/UTF-8) The first 128 Unicode characters (which corresponds directly to the ASCII character set) take only 1 byte. Example: Tele1 (English) is 5 bytes long. If you use special characters, more bytes are required. Refer to the table below for character limit information:
2-8 Installation Clinical Configuration Clinical Configuration Most of the clinical configuration of the MX40 is done in the Information Center;
however, several parameters can only be changed through the user interface at the MX40. These parameters are covered in Chapter 4 Configuration Mode. It is also possible to copy the clinical configuration from one MX40 to another one using the IntelliVue Support Tool Mark2. See the IntelliVue Support Tool Instructions for Use for details. Installation 2-9 Frequency Management and Channel Selection Frequency Management and Channel Selection Management of the RF environment in a facility is important to the overall performance of any wireless system. Philips cannot control what wireless devices are used in a hospital, but Philips or an authorized service provider will work with the hospital to select the best frequencies to use in order to avoid interference with other wireless devices used within the hospital. Frequency Management Frequency management is the selection of frequencies for wireless devices within a facility to prevent interference between devices. Frequency Management Responsibility Frequency management is the responsibility of the hospital. Philips has no control over the RF environment in a hospital. If interference exists at the operating frequencies, system performance will be affected. Careful selection of frequencies for all wireless devices used within a hospital is important to prevent interference between them. Channel Selection The MX40 has two radios a wireless network radio (8653501.4 GHz Smart-
hopping, 865351-2.4 GHz Smart-hopping or 865352802.11 a/b/g) and a short-range radio (optional). Channel selection for each product (865350, 865351, 865352) is different, therefore they will be discussed separately. A "clear" short range radio channel is defined as having a power level A "clear" Smart-hopping channel is defined as having a power level
< -80dBm.
< -90dBm. 865350 - Channel Selection WMTS (1.4 GHz) Smart-hopping Channel Selection The MX40 (865350) operates in the FCC-allocated, protected Wireless Medical Telemetry Service (WMTS) in the 1395-1400 and 1427-1432 MHz bands. 2-10 Installation Frequency Management and Channel Selection Note Per U.S. Federal Communications Commission (FCC) rules (Section 95.1111), operation of WMTS equipment requires device registration with an authorized Frequency Coordinator designated by the FCC before the equipment is commissioned. The American Society for Healthcare Engineering (ASHE) is the current designated Frequency Coordinator. The Smart-hopping channels that can be used, will be determined by this coordination process. A minimum of three Smart-hopping channels is required for proper operation of the system, but using more channels will improve performance. Smart-hopping channels are configured in the Access Point Controller. Frequency Coordination (USA, WMTS only) Frequency coordination is a registration and coordination process for wireless medical telemetry devices used in the U.S.A. which operate in the FCC-allocated, protected Wireless Medical Telemetry Service (WMTS) bands (608-614 MHz, 1395-
1400 MHz, 1427-1432 MHz). Registration/Coordination is a two-step process. Step 1: Registration of Facility: The healthcare facility must first register with ASHE. This is a lifetime, one-time application per facility. Facility registration confirmation must be received before proceeding to the next step, Registration of Devices and Frequency Coordination. Some helpful links:
For general WMTS information: http://www.ashe.org/wmts/index.shtml For a WMTS guide with registration instructions:
http://comsearch.com/products/online-tools/wmts-frequency-coordination/
Facility Registration: https://www.wmtssearch.com/wmts/controller and select Secure a WMTS Account Now Step 2: Registration of Devices and Frequency Coordination: After confirmation of registration, frequency coordination can begin. This step involves logging the equipment and frequencies used into the FCCs database, so as to identify any existing potential interference and to help prevent potential future interference. Frequency coordination is accomplished via the ASHE website provided above. The way the frequency coordination process is executed as of today, it will need to be repeated twice; once for 1395-1400 MHz band, and then again for the 1427-1432 MHz band, both of which are used concurrently by the Philips product. There is a separate fee for each coordination request. A certificate for each frequency band is issued. Installation 2-11 Frequency Management and Channel Selection To fill in the frequency coordination forms, you'll need to know the following:
The Frequency Range to be used: Two separate coordination submissions are required: For the first one, click on the range of 1395.0 through 1400.0 MHz. completed the registration. Then you will need to go through the process again for the second frequency band. For the second one, click on all the frequency ranges listed in the range of 1427.0 through 1432.0 MHz. The name/s of the Clinical Unit/s using the devices (e.g. ICU4, CCU-West, ER1, Step-Down North, etc.) Latitude and longitude that represents the center of the area where the transmitting devices will be deployed. Comsearch can help provide this information; www.comsearch.com. Google Earth is an excellent site to use for this information. County The radius of deployment, expressed in meters. The radius can be determined by drawing an imaginary circle around the center of the clinical unit that encloses/encompasses the unit. The number of the highest floor on which a transmitting device will operate. The number of transmitting devices will be used, i.e. the total number of MX40 devices, Access Points and Remote Antennas, etc. combined. For example: 12 MX40 and 15 AP would translate to 27 devices MX40 C/D (selection on Database) The Effective Radiating Power: 6.3 mW. (This will be automatically filled in once the device is selected) The Equipment Manufacturer: Philips Medical Systems. The Equipment Models: MX40, etc. current devices are registered as C/D version (A/B is for the older APs) After completing the device registration and frequency coordination, a WMTS Coordination Certificate is issued. Important Within 30 days, the installation date must be updated in the WMTS registration system. The installation date cannot precede the certificate date. 1.4GHz Smart-hopping Channel Definition 1.4GHz Smart-hopping Channel Definition - Standard Primary Channel 1:
Channel 2:
Low Center High 1395.0977MHz 1395.8977MHz 1396.6977MHz 1396.6970MHz 1397.4970MHz 1398.2970MHz 2-12 Installation Frequency Management and Channel Selection Primary Channel 3:
Channel 4:
*Channel 5:
*Channel 6:
Primary Channel 1:
Channel 2:
Channel 3:
Low Center High 1398.2963MHz 1399.0963MHz 1399.8963MHz 1427.0979MHz 1427.8979MHz 1428.6979MHz Secondary Low Center High 1428.6972MHz 1429.4972MHz 1430.2972MHz 1430.2965MHz 1431.0965MHz 1431.8965MHz 1.4GHz Smart-hopping Channel Definition - Carved-out Areas*
Low Center High 1395.0977MHz 1395.8977MHz 1396.6977MHz 1396.6970MHz 1397.4970MHz 1398.2970MHz 1398.2963MHz 1399.0963MHz 1399.8963MHz Channel 4a:
1429.4410MHz 1430.2410MHz 1431.0410MHz Secondary Low Center High
*Channel 4:
1427.0979MHz 1427.8979MHz 1428.6979MHz
*Carved-out areas apply to:
Counties Location Pittsburgh, PA Washington, DC Richmond - Norfolk, VA Allegheny, Beaver, Butler, Washington, Westmoreland Arlington, Fairfax, Loudoun, Prince William, Montgomery, Charles, Prince Georges, and Fauquier counties; cities of Alexandria, Fairfax, Falls Church, Manassas, Manassas Park and the District of Columbia Chesterfield, Goochland, Hanover, Henrico, Powhatan, Charles City, Dinwiddie, Isle of Wight, James City, New Kent, Prince George, Southhampton, Surrey, Sussex, and York counties; cities of Richmond, Norfolk, Newport News, Hampton, Virginia Beach, Chesapeake, Portsmouth, Suffolk, Colonial Heights, Franklin, Hopewell, Petersburg, Poquoson, and Williamsburg Austin - Georgetown, TX Williamson and Travis Battle Creek, MI Calhoun Oakland, Wayne, Washtenaw, Macomb, Livingston Spokane, WA and Kootenia, ID Detroit, MI Spokane, WA Installation 2-13 Frequency Management and Channel Selection 865350 - Short-range Radio (SRR) Channel Selection SRR with Cableless Measurements (Telemetry Use Model) The SRR channels are configured in the Information Center. Configure 2-4 channels as "High" and the rest "Off". The MX40 will select the best channel to use from those channels configured as "High". SRR with IntelliVue monitor (Bedside Use Model WTAAP) One SRR channel is configured in the bedside monitor. This is the channel the bedside will use to communicate with the MX40 and any Cableless Measurement pods. Select the best channel based on the interference level at the location where the bedside will be used. Warning The Short-range radio operates in the 2.4 GHz band. Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, Bluetooth devices, and DECT phones. The most likely interference will come from 802.11b, g wireless LANs. In order to reduce the chances of interference, the Short Range Radio channels should be chosen to operate at frequencies that avoid any 802.11 b/g channels that are in use in the hospital. In order to assist with this, recommendations for SRR channels based on possible 802.11 b/g WLAN channel deployments in the 2.4 GHz band are given in the table below. For example, if the hospital has an 802.11 deployment using 802.11 channels 1, 6, and 11, using the table below, short-range radio channels 25, 26, 15, and 20 are recommended. Using the diagram below to illustrate, SRR channel 15 operates between 802.11 channels 1 and 6, SRR channel 20 operates between 802.11 channels 6 and 11 and SRR channels 25 and 26 operate above 802.11 channel 11, thus minimizing interference with the WLAN that is deployed. The table below also lists some short-range radio channels that may be used if a frequency survey is performed and a power level check is done to ensure that the frequency is "clear" (has a power level < -80dBm). Note Channel overlap as shown in the diagram below is not totally accurate. There is not sufficient resolution to pick channels solely by using this diagram. Use it in conjunction with the table provided. 2-14 Installation Frequency Management and Channel Selection SRR Channel Recommendations for 865350 Installations. 802.11 b/g Channel Deployment Short-range Radio Channel Recommendations 1, 6, 11 1, 4, 7, 11 1, 4, 8, 11 25, 26, 15, 20 25, 26, 11*, 20*, 21*, 24*
25, 26, 11*, 17*, 18*, 24*
*Requires RF frequency survey and RF power level check for clear channels. Clear SRR channels have a power level < -80 dBm. Channel Comparison - SRR and 802.11 b,g Channels 865351 Channel Selection For 2.4 GHz Smart-hopping networks, both the Smart-hopping radio and the short-
range radio operate in the 2.4 GHz band, and therefore are subject to interference from other devices that operate in this band like 802.11 b/g wireless LANs, microwave ovens, Bluetooth radios, etc. The most likely interference will come from 802.11 b/g wireless LANs. In order to reduce the chances of interference, the Smart-hopping and short-range radio channels should be chosen to operate at frequencies that avoid any 802.11 b/g channels that are in use in the hospital. In addition, if the short-range radio will be used, interference between the Smart-
hopping radio and short-range radio must be avoided by separating these channels by a minimum of 5 MHz. Installation 2-15 Frequency Management and Channel Selection In order to assist with this, recommendations for Smart-hopping channels and SRR channels based on possible 802.11 b/g WLAN channel deployments in the 2.4 GHz band are given in the tables that follow. 2.4 GHz Smart-hopping Channel Selection A minimum of three Smart-hopping channels is required for operation of the system, but Philips strongly recommends selecting the maximum of six channels in order to improve performance. For example, if a 2.4GHz Smart-hopping network is being deployed without the short-range radio in a hospital with an 802.11 deployment of channels 1, 6 and 11, the best Smart-hopping channels to use would be the channels listed as "Primary"
in the table, "802.11 b/g Channel Deployment 1, 6, 11", under "Option 1". This would be Smart-hopping channels 13, 14, 28, 42, 43, 44, 45, 46, 47. The best six of these Smart-hopping channels across the whole coverage area should be selected. A clear Smart-hopping channel is defined as having a power level of < -90dBm. Using the diagram below to illustrate, Smart-hopping channels 13 and 14 operate between 802.11 channels 1 and 6, Smart-hopping channel 28 operates between 802.11 channels 6 and 11 and Smart-hopping channels 42, 43, 44, 45, 46 and 47 operate above 802.11 channel 11, thus minimizing interference with the WLAN that is deployed. 865351 - Short-range Radio (SRR) Channel Selection SRR with Cableless Measurements (Telemetry Use Model) The SRR channels are configured in the Information Center. Configure 2-4 channels as "High" and the rest "Off". The MX40 will select the best channel to use from those channels configured as "High". SRR with IntelliVue monitor (Bedside Use Model WTAAP) One SRR channel is configured in the bedside monitor. This is the channel the bedside will use to communicate with the MX40 and any Cableless Measurement pods. Select the best channel based on the interference level at the location where the bedside will be used. 2-16 Installation Frequency Management and Channel Selection Warning The Smart-hopping and short-range radios operate in the 2.4 GHz band. Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, Bluetooth devices, and DECT phones. The most likely interference will come from 802.11 b/g wireless LANs. Smart-hopping and SRR Channel Selection for 2.4GHz Smart-
hopping Networks If a 2.4 GHz Smart-hopping network is being deployed with the short-range radio in a hospital with an 802.11 deployment of channels 1, 6 and 11, a number of different deployment options are given in the table. The clearest frequencies should be assigned to the short-range radio, and then the Smart-hopping channels can be assigned. So if short-range radio (SRR) channels 25 and 26 are selected, then the best Smart-
hopping channels to use would be the channels listed as "Primary" in the table,
"802.11 b/g Channel Deployment 1, 6, 11", under "Option 2". This would be Smart-
hopping channels 13, 14, 28. Channels 42, 43, 44, 45, 46, 47 should not be used because they will interfere with the short-range radio. In addition to these three Smart-hopping channels, the best three channels of the "Secondary" (0 if allowed, 29) and "Tertiary" (12, 15, 27) channels listed should be selected. Using the diagram again, short-range radio channels 25 and 26 operate above 802.11 channel 11. This leaves the frequencies between 802.11 channels 1 and 6
(Smart-hopping channels 12, 13, 14 and 15) and the frequencies between 802.11 channels 6 and 11 (27, 28 and 29) as possibilities for the Smart-hopping channels. In these deployments, it is unlikely that all of the channels will be clear throughout the coverage area. A frequency survey is suggested to determine the best channels to use. A "clear" short range radio channel is defined as having a power level A "clear" Smart-hopping channel is defined as having a power level
< -80dBm.
< -90dBm. Installation 2-17 Frequency Management and Channel Selection Channel Comparison - SRR and 802.11 b,g Channels Note Channel overlap as shown in the diagram is not totally accurate. There is not sufficient resolution to pick channels solely by using this diagram. Use it in conjunction with the tables provided. 2-18 Installation Frequency Management and Channel Selection 802.11 b/g Channel 1,6,11 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. Installation 2-19 Frequency Management and Channel Selection 802.11 b/g Channel 1,4,7,11 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. 2-20 Installation Frequency Management and Channel Selection 802.11 b/g Channel 1,4,8,11 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. Installation 2-21 Frequency Management and Channel Selection 802.11 b/g Channel 1,7,13 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. 2-22 Installation Frequency Management and Channel Selection 802.11 b/g Channel 1,5,9,13 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. Installation 2-23 Frequency Management and Channel Selection 802.11 b/g Channel 2,7,12 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. 2-24 Installation Frequency Management and Channel Selection 802.11 b/g Channel 1,6,11,14 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. Installation 2-25 Frequency Management and Channel Selection 802.11 b/g Channel 3,10,14 Deployment
*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm. Clear Smart-hopping channels have a power level < -90dBm. 865352 - Channel Selection 802.11 Channel Selection 802.11 channel selection is done by the hospital. Due to the limited number of channels in the 2.4 GHz band, lower capacity, and higher number of native interferers, use of the 802.11a band is highly recommended. 865352 Short-range Radio (SRR) Channel Selection SRR with Cableless Measurements (Telemetry Use Model) The SRR channels are configured in the Information Center. Configure 2-4 channels as "High" and the rest "Off". The MX40 will select the best channel to use from those channels configured as "High". 2-26 Installation Frequency Management and Channel Selection SRR with IntelliVue monitor (Bedside Use Model WTAAP) One SRR channel is configured in the bedside monitor. This is the channel the bedside will use to communicate with the MX40 and any Cableless Measurement pods. Select the best channel based on the interference level at the location where the bedside will be used. Warning The Short-range radio operates in the 2.4 GHz band. Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, Bluetooth devices, and DECT phones. The most likely interference will come from 802.11b, g wireless LANs. The 802.11 version of the MX40 may only be used with short-range radio when the wireless network radio is operating in the 802.11a (5 GHz) band. In order to reduce the chances of interference, the Short Range Radio channels should be chosen to operate at frequencies that avoid any 802.11 b/g channels that are in use in the hospital. In order to assist with this, recommendations for SRR channels based on possible 802.11 b/g WLAN channel deployments in the 2.4 GHz band are given in the table below. For example, if the hospital has an 802.11 deployment using 802.11 channels 1, 6, and 11, using the table below, short-range radio channels 25, 26, 15, and 20 are recommended. Using the diagram below as illustration, SRR channel 15 operates between 802.11 channels 1 and 6, SRR channel 20 operates between 802.11 channels 6 and 11 and SRR channels 25 and 26 operate above 802.11 channel 11, thus minimizing interference with the WLAN that is deployed. The table below also lists some short-range radio channels that may be used if a frequency survey is performed and a power level check is done to ensure that the frequency is "clear" (has a power level < -80dBm). Installation 2-27 Frequency Management and Channel Selection SRR Channel Recommendations for 865352 Installations 802.11b/g (2.4 GHz) Channel Deployment Short-range Radio Channel Recommendations 1,6,11 1, 4, 7, 11 1, 4, 8, 11 1, 7, 13 1, 5, 9, 13 2, 7, 12 1, 6, 11, 14 3, 10, 14 25, 26, 15, 20 25, 26 11*, 20*, 21*, 24*
25, 26 11*, 17*, 18*, 24*
15, 16, 21, 22 11, 16, 21, 26 15, 20 25*
11, 12, 17, 18, 19, 24 12*, 13*, 16*, 17*, 20*, 21*, 24*, 25*
*Requires RF frequency survey and RF power level check for clear channels. Clear SRR channels have a power level < -80 dBm. Channel Comparison - SRR and 802.11 b/g Channels Short-range Radio Density A Short Range Radio cell is defined as a radius of 15ft (4.6m). A "Device Link" is defined by use model. Device Density per SRR Channel 1.4GHz Smart-
hopping Networks 2.4GHz Smart-
hopping Networks Maximum density of SRR Device Links in a single SRR cell 4 Device Links 3 Device Links 2-28 Installation Frequency Management and Channel Selection SRR with IntelliVue Cableless Measurements (Telemetry Use Model):
SRR with IntelliVue Monitor (Bedside Use Model):
Installation 2-29 3. Test and Inspection This section covers Test and Inspection tasks to be performed to ensure the performance of the MX40 after all installation procedures are completed. MX40 Test & Inspection Matrix ............................................................... 3-2 When to Perform Test Blocks ................................................................... 3-4 Test and Inspection 3-1 MX40 Test & Inspection Matrix MX40 Test & Inspection Matrix Test or "Inspection" to Perform Test Block Name Visual Test:
Power On:
Performance:
What to Record on Service Record V:P or V:F where P=Pass F=Fail Inspect the MX40 (and packing material if applicable) for obvious signs of damage. Also check external leads and accessories. Expected Test Results: The device does not have any obvious signs of damage = Pass Remove patient cable. Insert battery into the MX40. The MX40 will go through its self-test and pass. Make sure that an ECG wave appears on the screen and the battery gauge displays battery status. Check the INOP Area for any equipment malfunctions. PO:P or PO:F where P=Pass F=Fail P:P or P:F where P=Pass F=Fail The expected test result is pass: the MX40 boots up and displays an ECG wave and the battery gauge displays battery status. The wave will be a flat line if no simulator is attached. Expected Test Results: Expected answer is "yes". If so, Power On test is passed. 1. Insert battery into the MX40 for the channel being tested. 2. Attach a patient cable to the MX40 and an ECG simulator. 3. At the Information Center assign the MX40 being tested to a Sector. Ensure that the Multi-Function Button is turned "on", and turn on the SpO2 parameter if the MX40 being tested has the SpO2 option. Set the mode to Continuous. 4. An ECG waveform should be visible at the Information Center. 5. If the MX40 has the SpO2 option, connect an SpO2 sensor and apply the SpO2 sensor to yourself. Confirm that the MX40 completes a successful measurement. 6 .Set the SpO2 mode to the customer's desired setting, Continuous or Spot Check/Manual. 7. Place the device in Standby. At the Information Center, resume monitoring. 8. Press the Multi-Function Button on the MX40. The button press should generate one of the following, depending on the configured setting:
Nurse Call & Record - Nurse Call alarm and a recording generated at the Information Center. Nurse Call Only - Nurse Call alarm at the Information Center. Record Only - A recording generated at the Information Center. Disabled - No event at the Information Center. 3-2 Test and Inspection Test Block Name MX40 Test & Inspection Matrix What to Record on Service Record Revision Check:
Test or "Inspection" to Perform 9. If the MX40 has the Short-Range Radio option, establish communication between the MX40 and either the patient monitor or a cableless measurement device, depending on the chosen use model. If assigned to a patient monitor, an ECG waveform should be visible on the monitor. The display on the MX40 will be:
10. If assigned to a cableless measurement device, initiate a measurement and view it at the Information Center. Expected Test Results: Expected answer to all is "yes". If so, Performance test is passed. Check the revision of the software/firmware in the Device Info. screen. Check the INOP Area for either an "SpO2 Equip Malf"
or "Resp Equip Malf" message which indicates an SpO2 or Resp upgrade failure. The revision reported should match the revision loaded. You may also check the Status Log at the Information Center. Note: If the device has SpO2 hardware installed (option S02 or S04), after an upgrade if SpO2 is in Manual or Auto measurement mode, the SpO2 revision information will display as ??.??.??. To view the SpO2 revision information go to the SmartKeys and select Start SpO2, then return to the Device Info screen. Expected Test Results: Expected answer is "yes". If so, Revision Check test is passed. RC:P or RC:F where P=Pass F=Fail Test and Inspection 3-3 When to Perform Test Blocks When to Perform Test Blocks Service personnel should perform Test Blocks as identified in the following table. Service Event When performing... Test Block(s) Required Complete these tests Installation Visual, Power On, Performance Repairs/Replacement Visual, Power On, Performance Upgrades Revision Check Preventive Maintenance N/A Note There are no preventive maintenance tests required. All other Service Events Perform all Test Blocks 3-4 Test and Inspection 4. Operating Modes This section provides operation information about the MX40 when the device is in Monitoring Mode, Service Mode, Configuration Mode and Demo Mode. Configuration Mode ................................................................................ 4-30 Service Mode ............................................................................................ 4-33 Demo Mode .............................................................................................. 4-35 Operating Modes 4-1 Monitoring Mode Monitoring Mode Warning Caution Monitoring Mode is the normal operating mode of the MX40 and a password is not required. If the MX40 displays a SW License Required message, remove the device from service. The device must be repaired/replaced. Do not use pneumatic tube systems to transport this device or the rechargeable lithium-ion battery. Damage may result. Telemetry Mode Use To minimize patient disruption, the MX40 operates in Telemetry Mode when connected to the Information Center. In Telemetry Mode, the local volume is set to zero and the display is off. You can activate the display at any time by touching the Main Screen button for two seconds. All active alarms can be viewed when the display is on, however audible alarm indicators are not annunciated. Regardless of the display status, all measurement data is being sent to the Information Center. Telemetry Mode is only available when connected to the Information Center. Monitor Mode Use In Monitor Mode, the display is always on for easy viewing, and should an alarm condition occur, it will be announced locally at the MX40 and at the Information Center if networked connected. Be aware that when the display is on and alarms are audible, battery consumption will increase. To use Monitor Mode:
1. Press the SmartKeys Button. 2. Press the Mode: Telemtry / Mode: Monitor SmartKey and choose Mode: Monitor. 4-2 Operating Modes Monitoring Mode Note Anytime you are disconnected from the Information Center, the MX40 automatically activates Monitor mode. The MX40 reverts to Telemetry mode when connection to the Information Center is re-
established. If the MX40 is not connected to the Information Center, the alarm is only announced locally. For additional information regarding battery status during Monitoring Mode, see Note 3 under the Battery Charge Status section starting on page 4-28. Operating Modes 4-3 Monitoring Mode Controls, Indicators and Connectors This section describes the clinical controls of the IntelliVue MX40. These controls include buttons, display icons, visual and auditory indicators, ports, and safety labeling located on the front and back of the device. MX40 Controls and Indicators INOP Area 1. Patient Cable 2. Patient Information Area 3. Active Alarms Area 4. 5. Measurement Area 1 6. Measurement Area 2 7. Waveform 1 8. Waveform 2 9. Radio/Network/Battery Status Area 10. Leads Off Status Area 11. Silence/Acknowledge Alarms Button 12. SmartKeys Button 13. Main Screen Button 14. Multi-Function Button 4-4 Operating Modes Monitoring Mode Multi-Function Button Button Function Depending on configuration at the Information Center:
generates a Nurse Call;
Initiates a Delayed Recording;
Both, or;
None Note If appropriate, patients should be informed that the Multi-function button on the MX40 is not the primary method for generating a Nurse Call. Silence/Acknowledge Alarm Button Button Function Initiates a local silence/acknowledgment of all active alarms when enabled (IIC). Initiates a global silence/acknowledgment of all active alarms (IIC iX). Silences the "Find Device" sound. Note Alarms at the MX40 can be silenced from the Information Center. When silenced from the Information Center, the alarm sound is not silenced at the Information Center until it receives feedback from the MX40. This may take several seconds. SmartKeys Button Button Function Displays the SmartKey Menu on the touch screen. Main Screen Button Button Function Activates the display screen if touched for two Cycles through the display screens if touched seconds. repeatedly. Resumes from Standby. When pressed from a sub-menu, returns display to the Main Screen. Operating Modes 4-5 Monitoring Mode SmartKeys The following table lists the SmartKeys available on the display of the MX40. Notegray text on a SmartKey signifies that the item is unavailable. SmartKey Function Start SpO2 Starts a manual SpO2 measurement. Note This SmartKey is unavailable when SpO2 mode is continuous. Delayed Record Starts a delayed recording at the Information Center. Alarms Alarm Volume setting. Review of up to 50 previous alarm conditions (entries are stored during power cycle). Pause Alarms for configured time period (if enabled at the Information Center). Mode: Telemetry /
Mode: Monitor Toggles between modes. In Telemetry Mode, display and audio are off; in Monitor Mode, display and audio are always on. Standby Puts the device into Standby locally and at the Information Center. Displays purchased/enabled product options. To resume from Standby, touch the Main Screen button. Add/Remove Displays available monitors and IntelliVue Cableless Measurements to assign to via the short-range radio. Print Reports Prints the pre-configured report as designated at the Information Center. Trends View up to 24 hours of tabular and graphical trend data (Option C03). One hour tabular trend standard. 4-6 Operating Modes Monitoring Mode SmartKey Function Setup Screen Determines time period that the display remains active after user interaction or whether the display is always On or always Off. Lock/Unlock Locks/Unlocks the display. Op Modes Selects either Monitoring, Demo, Config or Service modes. The Alarm Area of the MX40 displays physiological alarms and technical alarms. A multiple alarm indicator (down arrow) is displayed when multiple alarm conditions are present and the alarm message rotates every 3 seconds. A check mark in front of the alarm text signifies that the alarm has been acknowledged by touching the Silence Alarms button at the MX40 or IIC iX. Alarm Indicators display in the Patient Information Area in place of the time clock when alarm/INOP conditions are present but have not been acknowledged. Touching the Alarms Area displays a list of all active alarms. The alarms paused icon communicates whether the alarm system is on/off. When alarms are paused from the IIC, the display wakes at half brightness to indicate the alarm pause state. Local Alarm Audio is off when the alarm volume is present next to the time. The Local symbol Audio Off message is displayed as a reminder that alarms are never annunciated in Telemetry Mode. Alarms Area Operating Modes 4-7 Monitoring Mode Patient Information Area The Patient Information Area displays the following information:
Bed Label Patient Name (up to 18 characters will display) Time Touching the Patient Information Area displays the Patient Demogr. menu which lists the following:
Patient Name (Last, First, Middle) Lifetime ID Encounter ID Patient Category Paced Mode Height Weight Date of Birth Gender Paced Status Display Lock Status Area Note If you use an alternative ID, it will display at the Information Center and on printed reports. It will not display at the MX40. 1. Pacing algorithm is on. 2. Pacing algorithm is off. 3. Pacing algorithm is on. Patient's paced status is unknown. The Lock symbol appears in the lower left of the display when the MX40 is in a locked state after a configured time of non-use (1-30 minutes, default of 1 minute), or if configured to do so during the start-up process. Locking the display provides additional protection against accidental patient access. The display is unlocked using the SmartKeys menu. Additionally, the MX40 can be configured to require a 3-5 digit numeric only password to unlock the device. The status area of the MX40 displays short-range radio connection (optional) and system wireless connection status. You can also view battery strength for the type of battery used in the device, AA or rechargeable Li-on. 4-8 Operating Modes Monitoring Mode Operating and Navigating The principal method of operating your MX40 is via the Touch Display. Almost every element on the display is interactive. Display elements include measurement numerics, information fields, alarm fields, waveforms, SmartKeys and menus. Power-On Self Test Once battery power is supplied, the MX40 performs a power-on self test to check operational status prior to start-up. This process takes approximately 45 seconds. Subsequent connection to the Information Center then occurs within approximately 30 seconds. Should a failure be detected, an INOP tone will sound and if possible, the appropriate INOP message for the failure will be communicated to the Information Center and displayed locally. For MX40 WLAN devices, a graphic will display if AA batteries are inserted into the MX40 to remind the user that only the Philips rechargeable lithium-ion battery pack is to be used. Warnings If the MX40 enters a continuous "boot-up" cycle or the main screen does not appear or update, ensure that you are using a freshly charged lithium-ion battery or new disposable batteries. If the batteries are fresh and the device reboots or does not update, remove the device from service. Should the MX40 fail its alarm sound test (no sound played) or the Speaker Malfunct INOP is displayed, remove the device from use. Ensure that your MX40 connects to the Information Center. You can verify this by confirming the following:
the bed label appears in the top left corner of the display. the No Central Monit. INOP is no longer displayed and has been replaced by Local Audio Off. device sounds have ceased, and after one minute (configurable) the display is no longer active. Operating Modes 4-9 Monitoring Mode Check that the above actions occur and that you are connected to the Information Center when in the wireless coverage area. If you are not in range of the Information Center, the device continues to sound and the display remains active. A successful power-on self test will then transition the MX40 to the start-up screen. Selectable background colors can be configured and display on the screen for assistance with device identification. This can be helpful when devices are in a pooled use setting. You must visually check that a waveform is present on the display. You can access further status information is by touching the status area on the display. On a daily basis, the clinician should inspect the MX40 and accessories. Replace any damaged equipment or accessories. Touch Sensitive Display The display area of the MX40 is touch sensitive and can be touched with your fingertip or thumb through the Philips Waterproof Carrying Pouch or medical gloves. Do not use a pen or stylus. When touched, the element is highlighted. After removing your fingertip or thumb, a white dot is displayed to guide you by showing the location of your touch. When the display is locked, a red dot is displayed. Navigating Touching the Navigation Bar on the right of the display will scroll through additional display items. Solid downward arrows indicate there are additional elements that are not currently displayed. The arrows briefly illuminate when touched. Your selection from the menu also illuminates when touched. Selecting Display Elements Touch a display element to get to the actions linked to that element. For example, touch the Patient Information element to call up the Patient Info window, or touch the HR numeric to call up the Setup ECG menu. Touch the ECG waveform to call up the wave selection menu. 4-10 Operating Modes Monitoring Mode Locking the Display To provide additional protection against accidental patient access to the MX40, the display can be locked using the Lock SmartKey. When Lock is selected, the SmartKey menu automatically changes to the Main Screen. When Unlock is selected, you must close the SmartKey menu to return to the Main Screen. To provide additional security to prevent patient access, the MX40 can be configured to require a 3-5 digit numeric only password to unlock the device. To unlock the display, the password must be entered every time the configured time of non-use is exceeded. Display Auto-Lock The display automatically locks when there is no interaction for the configured time period (1-30 minutes with a default of 1 minute), or if configured to do so during the start-up process. Function Display Locked /
Display On Display Locked /
Display Off Display Unlocked /
Display On Display Unlocked /
Display Off Display Touch Main Screen Button No No SmartKeys Button Yes Silence Button No No Yes No No Yes Yes Yes Yes No Yes No No Measurement Area The measurement area of the MX40 display is optimized to show available parameter numerics, waveforms, and alarm limits. Each element is a touch object and when you select it, further controls and menus become available. Measurement Area Display Configurations The display of your MX40 is configured/can operate in one of five available orientations:
Portrait - No Waveforms and six Numerics (IIC iX only) Portrait - One Waveform and four Numerics Portrait - Two Waveforms and two Numerics (IIC Release N and IIC iX Landscape - Two Waveforms and three Numerics (IIC Release N and only) IIC iX only) Portrait - Viewable Chest Diagram and two Numerics Operating Modes 4-11 Monitoring Mode Identifying the SpO2 Patient Cable Type The patient cable with SpO2 is available in two versions, Philips FAST and Masimo SET. Each cable contains the markings as shown in the diagram below. Note For more information on cable/device identification, see the MX40 SpO2 Option Quick Card, p/n 4535 648 13471. Note The Philips FAST patient cable is not compatible with Masimo SET devices. The Philips Masimo SET patient cable is not compatible with Philips FAST devices. An Invalid Leadset INOP will display, along with instruction to connect the proper patient cable. 4-12 Operating Modes Monitoring Mode Connecting/Disconnecting the Patient Cable The patient cable is connected to the MX40 as shown in the illustration below. When connecting to the MX40, there is a slight clicking sound that signifies that the cable is securely connected. Typically, the patient cable may be disconnected as shown below. Caution To avoid dislodging the gasket in the patient cable, use a straight-on approach when attaching. Do not use a pivot motion to attach the patient cable connector to the MX40. Operating Modes 4-13 Monitoring Mode During initial use of the MX40, the secure connection between the patient cable and the device may be difficult to disconnect. Should this occur, use the alternative procedure shown below. Caution Never disconnect the patient cable by pulling on the leadwires or the SpO2 adapter, as this may damage wires over time. Changing Measurement Settings Each measurement has a setup menu in which you can adjust its settings. You enter the setup menu by selecting the measurement numeric. You must be aware that, although many settings can be changed during use, permanent changes to settings can only be done in Configuration Mode. All settings are restored to their default setting when the patient is discharged or the MX40 is powered off. ECG Settings at the MX40 Setting Alarm Limits Primary
(used for arrhythmia analysis only)
(Set at IIC Release N or IIC iX. View only.) Secondary
(used for arrhythmia analysis only)
(Set at IIC Release N or IIC iX. View only.) Description Heart Rate alarm limits can be viewed locally at the MX40. Limits set at the Information Center
(Release N or later or iX) are reflected at the MX40 when connected on the network. I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R. Available waveforms are based on lead set type. Lead II is the default. I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R, V5R. Available waveforms are based on lead set type. Lead V is the default. 4-14 Operating Modes Monitoring Mode
(Set at IIC Release N or IIC iX. View only.) Setting Paced Mode Adjust Size Arrhythmia Lead Placement ECG New Lead Setup Va Lead Vb Lead Change Numeric Setting Wave 1 Wave 2 Description On, Off, Unconfirmed (IIC iX only) Set ECG gain to x1/2, x1, x2, x4 Initiate an Arrhythmia Relearn; View Arrhythmia Alarm Limits; Turn Arrhythmia Annotation On/Off
(local control on device only.) Set EASI, Standard Set ECG On/Off When IntelliVue Patient Monitor lead sets are in use, select 3-wire, or 5-wire. Shows position of Va, or Ca, electrodes. Choices are V1-V9, v3R, V4R, V5R. Configured at IIC/IIC iX. Shows position of Vb, or Cb, electrodes. Choices are V1-V9, v3R, V4R, V5R. Configured at IIC/IIC iX. Selects parameter numeric to display in place of current HR numeric. Description Primary, Secondary, I, II, III, aVR, aVL, aVF, V1-
V9, MCL, V3R, V4R, V5R, Pleth (if SpO2 is available), Resp (if Resp is available). Available waveforms are based on patient cable type. Primary wave is the default. If Primary or Secondary are selected, then the waveform displayed is the waveform configured as primary or secondary for arrhythmia analysis at the Information Center. Primary, Secondary, I,II, III, aVR, aVL, aVF, V1-
V9, MCL, V3R, V4R, V5R, Pleth (if SpO2 is available), Resp (if Resp is available). Available waveforms are based on patient cable type. Secondary wave is the default. If Primary or Secondary are selected, then the waveform displayed is the waveform configured as primary or secondary for arrhythmia analysis at the Information Center.. Note ECG monitoring is turned off when the SpO2 only adapter accessory is attached to the MX40. When a battery change occurs, ECG monitoring resumes if the SpO2 only adapter accessory is no longer attached. Waveform Settings at the MX40 Operating Modes 4-15 Monitoring Mode Note Primary or secondary waveform configuration changes made at the Information Center change what is displayed on the MX40. But changes made locally at the MX40 do not affect settings at the Information Center. Selecting Pleth or RESP to display at the Information Center affects ECG wave storage for future review at the Information Center. Battery Information Battery Safety Information Warnings The battery compartment door must be closed during defibrillation. Use the Philips Rechargeable Lithium-ion Battery or 3 Duracell Alkaline batteries, size AA, MN 1500, 1.5V, to ensure specified performance and correct battery gauge reporting. Outdated, mismatched, or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). If you are using disposable batteries, the use of fresh high-quality alkaline batteries is strongly recommended. Certain failure conditions, such as short circuits, can cause a battery to overheat during use. High temperatures can cause burns to the patient and/or user. If the MX40 becomes hot to the touch, remove it from the patient and place it aside until it cools. Then remove the batteries and discard them. If you receive a TELE BATTERY LOW, TELE BATT EMPTY, REPLACE TELE BATT, or TELE BATTERY TEMP alarm, the batteries must be promptly replaced. If these conditions are not corrected, they will result in a device shutdown and cessation of monitoring. These INOPS also apply when monitoring with Cableless Measurements. Disposable batteries should be removed from the MX40 at the end of the batterys useful life to prevent leakage. Use only the Philips manufactured Rechargeable Lithium-ion Battery. Do not use other types of rechargeable batteries. Other types of rechargeable batteries will adversely affect:
- Battery gauge performance
- Battery low warnings
- Battery life performance 4-16 Operating Modes Monitoring Mode Do not store batteries in the MX40 in a reverse polarity position. This can cause leakage and corrode the battery terminal. This corrosion can create a short in the battery adapter which can cause the batteries to overheat. If battery leakage should occur, use caution in removing the battery. The leaked substance may cause eye or skin irritation. Avoid contact with skin. Wash hands. Replace the battery tray if exposed to battery leakage. Continued use increases the risk of batteries shorting and overheating, potentially resulting in burns to the user. To eliminate the risk of electrical shock or burn, do not carry loose batteries on your person, e.g. in clothing pockets. Use of AA Lithium batteries or batteries with terminal voltage >1.6V may cause damage to the device. Caution When monitoring with the WLAN version of the MX40 (Model 865352), the lithium-ion rechargeable battery is the only approved power source. Use of AA disposable batteries is not supported. Lithium-ion Rechargeable Battery Care Care of the rechargeable battery begins when you receive a new battery for use and continues throughout the life of the battery. The table below lists battery care activities and when they should be performed. Activity When to Perform Perform a visual inspection. Before inserting a battery in the MX40. Charge the battery. Clean the battery Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible. At each patient discharge, or in cases when the battery is exposed to contaminants. Charge stored batteries to at least 90% of their capacity every six months. When not in use for an extended period of time. Operating Modes 4-17 Monitoring Mode Activity When to Perform Decommission the battery When any of the following INOPs are displayed on the MX40:
TELE SERVICE BATTERY TELE BATTERY TEMP TELE REMOVE BATT Note When the above INOPs occur, the Tele Batt Low INOP is suppressed. Rechargeable batteries are charged using the IntelliVue CL Charging Station. For information on charging station use, see Charging Li-ion Rechargeable Batteries p. 5-10 . Note The battery capacity of rechargeable batteries degrades over time and number of recharge cycles. Toward the end of its useful life, the battery capacity may be reduced by 30%. If this reduced battery life is unacceptable based on your use model, Philips recommends replacing the rechargeable battery sooner. Lithium-ion Rechargeable Battery Storage When storing rechargeable batteries, make sure that the battery terminals do not come into contact with metallic objects or other conductive materials. If batteries are stored for an extended period of time, they should be stored in a cool, dry place, ideally at 15oC (60oF), with a state of charge of 20% to 90%. Storing batteries in a cool place slows the aging process. The batteries should not be stored at a temperature outside the range of -
20oC (-4oF) to 50oC (122oF). Stored batteries should be should be charged to at least 90% of their capacity every 6 months. They should be charged to full capacity prior to use. Note Storing batteries at temperatures above 38oC (100oF) for extended periods of time could significantly reduce the batteries' life expectancy. Lithium-ion Rechargeable Battery Handling Precautions Lithium-ion batteries store a large amount of energy in a small package. Use caution when handling the batteries; misuse or abuse could cause bodily injury and/or equipment damage. 4-18 Operating Modes Monitoring Mode Do not short circuit - take care that the terminals do not contact metal
(e.g. coins) or other conductive materials during transport and storage. Do not crush, drop or puncture - mechanical abuse can lead to internal damage and internal short circuits that may not be visible externally. Do not apply reverse polarity. Do not incinerate batteries or expose them to temperatures above 60oC
(140oF). If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:
discontinue use. dispose of the battery in accordance with the disposal instructions. Inserting/Removing Batteries Warning Arrhythmia relearning is initiated whenever the MX40's batteries are removed for one minute or longer. Be sure to check your patients arrhythmia annotation for accuracy whenever relearn has occurred. Caution Remove the batteries before storing the MX40 for an extended period of time. The battery compartment is located on the back of the MX40, accessible by opening the compartment door from the bottom. It accommodates three AA 1.5V alkaline batteries or the Philips Rechargeable Lithium-ion battery. Only these batteries should be used. Note Lithium-ion batteries should be fully charged prior to first use. Operating Modes 4-19 Monitoring Mode Inserting Batteries Insert the rechargeable lithium-ion battery using the following procedure:
Open the battery compartment by lifting up on both bottom sides of the compartment door. Remove the AA battery tray if present. Insert the battery pack so that the raised tab is aligned with the cutout in the base of the battery compartment. Close the battery compartment door. Watch for the start-up screen on the front of the MX40 to illuminate briefly. Insert AA batteries into the MX40 using the following procedure:
1. Open the battery compartment by lifting up on both bottom sides of the compartment door. 2. Insert the AA battery tray if not already present. 4-20 Operating Modes Monitoring Mode Ensure that the AA battery adapter is inserted into the battery compartment in the correct orientation. If the battery adapter is inserted fully with the orientation reversed, it will be difficult to remove. Caution Do not use any tools to pry or pull the battery adapter tray out of the battery compartment as this can result in damage/breakage of the retention tabs that are integral to the MX40/battery compartment. AA Battery Adapter Insertion:
2a - Align the cutout in the back of the adapter with the post on the wall of the MX40 battery compartment. Please note that the +
symbols for the batteries will be on left side of the adapter when oriented properly as shown in the diagram below:
Operating Modes 4-21 Monitoring Mode 2b - Slide the adapter under the post as shown below:
2c - Snap the adapter in by pushing down on it:
4-22 Operating Modes Monitoring Mode AA Battery Adapter Removal:
2d - To remove the AA battery adapter, push inward and then gently pull up on the white tabs on both sides of the adapter to free it from the retention pins on the MX40. A tool is not needed. Use of any tools to pry or pull the battery adapter tray out of the battery compartment can result in damage/breakage of the retention tabs that are integral to the MX40. 2e - Once the adapter is free of the retention pins, it can be removed completely from the MX40. Operating Modes 4-23 Monitoring Mode 4-24 Operating Modes Caution The MX40 Battery Adapter Tray requires routine inspection, and will require replacement when visible signs of wear are present, including corrosion, cracks, bends, crimping, or curling that can prevent disposable batteries from remaining securely in the tray. It is recommended that the MX40 Battery Adapter Tray be replaced every 12 months or when visible wear is recognized. A date code is included on the Battery Adapter Tray to help you identify the 12-month time period with a format of YY/MM, e.g. 15/11 meaning November 2015. 3. Insert three Duracell AA 1.5V Alkaline batteries, matching the polarity with the + indications inside the compartment. Noteall batteries are inserted with the + polarity in the same direction. Use of AA batteries is not supported with the WLAN MX40 (Model Number 865352). Use only the rechargeable lithium-ion battery. 4. Close the battery compartment door. 5. Watch for the start-up screen on the front of the MX40 to illuminate briefly. Removing the Batteries Monitoring Mode Batteries should be removed when the MX40 is not in use or is being stored. To remove the batteries, open the battery compartment door and push from the opening at the bottom of the compartment to pop the batteries out. To remove the rechargeable battery, open the battery compartment door and lift up on the raised tab on the battery to release it from the battery compartment. Device settings (patient cable type, SpO2 mode, volume, etc.) are retained when the batteries are removed. Important Do not use AA batteries that have different energy levels remaining. Fresh AA batteries are recommended for each new application. Caution Do not "store" disposable AA batteries by leaving them in the incorrect polarity position in the MX40. Be careful not to short circuit the batteries. Batteries can get hot when shorted. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously. More than a momentary short circuit will generally reduce the battery life. In case of a short circuit, discard the batteries, or just the shorted one if the batteries are new. Failure to remove the rechargeable battery from the MX40 when the device is not in use may result in damage to the battery, including reduced capacity, inaccurate charge status indicator, failure to charge, and failure to function in the MX40. Disposal of Batteries When disposing of batteries, follow local laws for proper disposal. Dispose of batteries in approved containers. If local regulations require you to recycle batteries, recycle batteries in accordance with those regulations. Operating Modes 4-25 Monitoring Mode Battery Charge Status The battery charge indicator displays in the Status Area and communicates the remaining battery charge time when using both AA batteries and the rechargeable lithium-ion battery. When the MX40 is initially powered-on, it takes approximately 25 seconds for the indicator to populate. During this time, the indicator displays a ? in the battery icon. In order to guarantee overall device performance, certain functionality is disabled when the battery charge reaches critical levels. See the diagram below for additional information about battery status. When monitoring SpO2 and the battery reaches a low battery state, the Tele Battery Low INOP is displayed for approximately 10 minutes. After this time period, No SpO2T, Batt Low and Tele Battery Low are displayed for an additional 10 minutes (approximate). If you need to continue to monitor SpO2, replace your batteries during the initial Tele Battery Low period. Once the time period has elapsed, a 3rd INOP is displayed - Tele Replace Batt/Tele Batt Empty. This INOP is displayed for at least 10 minutes, but can also display for several hours depending on your environment. During the Tele Replace Batt/Tele Batt Empty period, the MX40 will continue to send ECG monitoring information to the Information Center for as long as possible. Once battery power is completely depleted, monitoring will stop completely and 2 INOPs are displayed at the Information Center Replace Tele Batt/Tele Replace Batt (or Tele Batt Empty) and No Signal/No Data Tele. Failure to replace battery power in a timely manner will cause monitoring and physiological alarms to cease. 4-26 Operating Modes Monitoring Mode MX40 Performance at End of Battery Life Note 1 If the SRR is already connected, SRR connectivity continues. In this state, it is not possible to start a new SRR connection. Note 2 If the display is already turned on, the display will dim, but will continue to function. In this state, it is not possible to turn the display on if it is off. Note 3If the Tele Battery Low INOP occurs and then the MX40 disconnects from the network, the behavior and timing described in the diagram above does not apply. The screen activates to show a large red
, and the device plays an escalating double beep sound to battery icon indicate that it is disconnected from the network. Alarm and SpO2 monitoring are no longer available locally. The MX40 will attempt to reconnect to the Information Center to transmit the battery INOP condition. Operating Modes 4-27 Monitoring Mode Service Information Available in Monitoring Mode While the MX40 is operating in Monitoring Mode, important Service information is available by touching the Status Area. You can view radio signal strength and device specific information, such as serial number and software and hardware revisions. 4-28 Operating Modes Monitoring Mode Operating Modes 4-29 Configuration Mode Configuration Mode For information on configuration settings that are entered at the MX40, see the IntelliVue MX40 C.01 Configuration Guide contained on the MX40 Documentation CD, p/n 4535 647 51811. For information on configuration settings that are entered at the Information Center, see the Patient Information Center iX Clinical Configuration Guide, Release C.03 contained on the MX40 Documentation CD, p/n 4535 647 51811. Configuration Mode is password protected. The password to enter is
"71034". This password may be modified. See Change Password on pg. 4-28. Clinical Configuration The table below lists the settings that are configured using the Configuration menu:
Setting Description MX40 with IIC N MX40 with IIC MX40 with IIC iX L/M 0-10 4 0-10 4 Touch Tone Volume:
Audio feedback for button touch events. Mute (0) or allow sound feedback 0 -10 4 Default Screen:
Screen displayed after power on 1 wave - P(ortrait) Chest Diagram 1 wave - P(ortrait) 2 waves - P(ortrait) 2 waves - L(andscape) Chest Diagram All numerics The default setting at IIC iX overrides the MX40 Default Screen setting. Additional 6 numerics (no waves) screen available, but cannot be configured as Default Screen. Blue, Gray, Green, Pink*, Purple*, Yellow*
> B.05 Blue, Green, Purple, Orange*, Aqua
(* only display in Standby Mode) Screen Color:
Blue, Gray, Green, Pink, Purple, Yellow Blue, Gray, Green, Pink, Purple, Yellow
< B.04 The color of the Standby screen can be changed. This can be used to distinguish devices between different units, e.g. Blue for CCU, Green for ED Note Blue, Gray, and Green apply to both Startup and Standby screens. Pink, Purple and Yellow apply to Standby screen only. AAMI, IEC AAMI, IEC AAMI, IEC ECG Cable Color:
These are the colors that will be displayed on the chest diagram if a patient cable type cannot be determined. 4-30 Operating Modes Configuration Mode Setting Description MX40 with IIC N MX40 with IIC MX40 with IIC iX L/M Alarm Sounds:
Traditional, ISO Traditional, ISO Traditional, ISO Sets MX40 alarm sound type to Traditional
(Carenet) or ISO. Enable: All MX40/IIC Release N features available. Disable: MX40 operates as if connected to IIC Release L/M. Sets the default automatic lock time
(minutes). Alarms On:
Disable, Enable Disable Enable (cannot disable - MX40 is the alarm manager) Note This configuration item is not available when operating with IIC iX. Lock Time 1, 2, 5, 15, 30 1, 2, 5, 15, 30 1, 2, 5, 15, 30 Unit Defaults:
The table below lists the settings that are configured using the SmartKeys menu:
Setting Description MX40 with IIC N MX40 with IIC MX40 with IIC iX Alarm Volume for Off Network:
Sets the default alarm volume when the device goes off network 10 only L/M 10 only 10 only Inop Reminder:
Inop reminders on or off Set at IIC On, Off Set at IIC iX Set at IIC Red, Yellow, Cyan Set at IIC iX Sets the severity of the
"ECG Leads Off",
"Replace Battery" and Leadset Unplugged INOP conditions Inop Severity:
ECG Leads Off Replace Battery Leadset Unplugged Invalid Leadset Screen On Time Sets default screen on time (minutes) Trend Group Sets default trend group type: Standard (no ST/QT) or Cardiac
(includes ST/QT) 1, 2, 5, 15, 30 1, 2, 5, 15, 30 Set at IIC iX Standard (Cardiac not available) Standard (Cardiac not available) Standard, Cardiac Trend Interval Sets default trend interval time 1, 5, 10, 15, 30, 1 hour, 2 hours 1, 5, 10, 15, 30, 1 hour, 2 hours 1, 5, 10, 15, 30, 1 hour, 2 hours Operating Modes 4-31 Configuration Mode The table below lists the settings that are configured using the individual parameter Setup menus for ECG, SpO2 and Resp:
Setting Description MX40 with IIC N MX40 with IIC MX40 with IIC iX L/M Lead Placement: Sets the default lead Standard, EASI Standard, EASI Set at IIC iX placement to either Standard or EASI ECG. This impacts the leads that are selectable and the location of the electrodes displayed on the Chest Diagram. Sets the default SpO2 mode to either Manual or Continuous. SpO2 Mode:
Manual, Continuous Manual, Continuous Set at IIC iX (Auto also available) The following choices are available if the waveform displayed is:
Change Wave 1
/ 2 ECG Pleth Resp Primary Lead, Secondary Lead, Pleth Primary Lead, Secondary Lead, Pleth Primary Lead, Secondary Lead, Pleth Any ECG Lead, Any Pleth Any ECG Lead, Any Pleth Any ECG Lead, Any Pleth, Any Resp n/a n/a Note Wave 1 on MX40 defaults to ECG Wave - Primary Lead. Wave 2 on MX40 defaults to PlethT. x1/2, x1, x2, x4 x1/2, x1, x2, x4 x1/2, x1, x2, x4 n/a x1/2, x1, x2, x4 ECG Wave Adjust Size Sets default ECG wave size on MX40. RESP Wave Adjust Size Sets the default Respiration size (MX40 and IIC iX) n/a Default Settings = Bold. Note The IntelliVue Support Tool - Mark 2 can be used to copy the configuration of one MX40 to another MX40. It can also be used to copy passwords from one MX40 to another MX40. 4-32 Operating Modes Service Mode Service Mode This section describes the menus and settings accessed from the Service Operating Mode. Service Mode is password protected. The password to enter is "1345". This password may be modified. See below. Change Password The Change Password menu allows you to set new passwords on the MX40 for access to Configuration Mode, Service Mode and Demo Mode. Passwords must have a minimum of three numerical characters and a maximum of five numerical characters. 1. Enter current password. 2. Enter new password. 3. Re-enter new password. Setup Network Revisions The Setup Network menu allows you to set the RF Access Code for the MX40. The Revisions menu displays the Device Info menu:
Service #: This is the Service Identification Number located on the back label and used to identify the device. S/N: This is the Hardware Serial Number for the device located on the back label and used to identify the device. SW Service #: This is the Service Identification Number for the software version on the device. It can be found on the Software License Certificate that shipped with the Device. SW SN: This is the Software License Number. It can be found on the Software License Certificate that shipped with the device. Note Customers should save the Software License Certificate for future reference. Appl SW: This is the revision of the software installed and running on the MX40. HW Rev: This is the Revision Number for the device hardware. Operating Modes 4-33 Service Mode Options: List of enabled product options on the device. Enabled Product Option # Product Option S01 S02 S03 S04 C01 C03 J46 M02 ECG and SpO2 Ready (for future upgrade) ECG only ECG and SpO2 ECG and SpO2 (Masimo) Enhanced Arrhythmia 24 hours of Vitals Trends Short-Range Radio Impedance Respiration Rechargeable Battery Information The Batt Info menu displays information about the rechargeable battery. Touch the Device Status area and then the battery area to display:
Rechargeable: The battery type. Percent Remaining: Remaining battery capacity. Voltage: Current voltage measurement. Av. Current: Average current measurement. Av. Power: Average current power measurement. Temp: Current operating temperature. Ch Cycle: The number of charge cycles the battery has undergone. 4-34 Operating Modes Demo Mode Demo Mode The MX40 has a Demo Operating Mode available for assistance in sales and training situations. Demo Mode is password protected. The password to enter is "14432". This password may be modified. See Change Password on pg. 4-28 In Demo Mode, all menus are accessible, and all buttons and SmartKeys are operational. There is a simulated ECG wave on the display, and the alarm system is functional. Data is transmitted to the Information Center and is labeled "Demo" in the patient sector and on the MX40 in the Leads Off Status Area. Operating Modes 4-35 5. Maintenance This section provides procedures for maintaining the MX40 after installation, including equipment label assignment, cleaning and battery care. Cleaning ...................................................................................................... 5-2 Disposing of the MX40 .............................................................................. 5-7 Label Assignment for Replacement MX40 ............................................. 5-8 Charging Lithium-ion Rechargeable Batteries .................................... 5-10 Maintenance 5-1 Cleaning Cleaning The procedure in this section keeps the MX40 and its accompanying patient cable clean and provides protection against infectious agents and bloodborne pathogens. Both the outside and the inside of the MX40 battery compartment and the patient cable must be kept free of dirt, dust, and debris. After use, the MX40 and accessories must be cleaned as per the instructions contained herein. Use only the recommended cleaners and disinfectants listed in the table below. Others may cause damage (not covered by warranty), degrade performance, reduce product lifetime, or cause safety hazards. Caution Note Sterilization of the MX40 has been qualified using the STERRAD 100NX System. For more information and instruction on sterilizing the MX40, please contact your Steris representative. The alternative Steris V-pro process using hydrogen peroxide vapor is also acceptable. Note Single-Patient-Use leadsets are intended to be disposed of when use is complete. They are not to be re-used and are not designed to be cleaned using any of the materials listed below. Note The MX40 Battery Adapter Tray requires routine inspection and will require replacement when visible signs of wear are present, including cracks, bends, crimping, or curling that can prevent disposable batteries from remaining securely in the tray. It is recommended that the MX40 Battery Adapter Tray be replaced every 12 months or when visible wear is recognized. Perform the following steps to clean the MX40 and the patient cable of visible surface contamination. Note when cleaning, the use of protective gloves is encouraged. 5-2 Maintenance Cleaning 1. Remove the batteries and disconnect the patient cable. Note that disconnecting the patient cable for cleaning is dependent on your hospitals protocol. The connection between the MX40 and the patient cable is rated IPX7 (protected against the effects of temporary immersion in water). Care must be taken to ensure this area of connection is completely dry prior to reconnecting the MX40 with the patient cable. The MX40 and patient cable must be connected correctly and completely in order to maintain the IPX7 rating. The battery compartment of the MX40 has an IPX3 rating
(protected against the effects of spraying water). If using disposable AA batteries, remove the battery adapter tray and clean separately. Dispose of AA batteries according to hospital policy. If using the MX40 rechargeable battery, remove and clean separately. 2. Clean the MX40, rechargeable battery, patient cables, and battery adapter tray before disinfecting. 3. Wipe the MX40, rechargeable battery, and patient cables using a lint-free cloth dampened modestly with one of the approved cleaning or disinfecting agents listed in the table below. If using a cotton swab to clean or disinfect, swabbing should be unidirectional at a time. Parallel strokes should be used to cover the entire swab area as shown below. Start End Start 4. Wipe the exterior surfaces of the patient cable using a lint-free cloth dampened modestly with one of the approved cleaning or disinfection agents listed in the table below. If the interior surfaces of the patient cable connector require disinfection, wipe using a lint-free cloth dampened modestly with isopropyl alcohol only. Wipe between and around the MX40 connector pins to remove chemical residue. 5. Wipe the outside surfaces of the battery adapter tray with one of the approved cleaning or disinfecting agents listed in the table below. Wipe the inside surfaces of the battery adapter tray with a lint free cloth dampened modestly with isopropyl alcohol. 6. Follow the manufacturer's instructions with regard to application duration. Maintenance 5-3 Cleaning Cautions 7. Remove cleaner residue by wiping the MX40, exterior surfaces of the patient cables, rechargeable battery, and battery tray with a lint-free cloth modestly dampened with distilled water or isopropyl alcohol. 8. Allow to air-dry, or dry with a non-lint producing cloth. 9. Store the MX40 until ready to re-use. Do not insert rechargeable or disposable batteries until ready for use. Never immerse or soak the MX40, the patient cable, the batter adapter tray, or the rechargeable battery in any liquid solution for cleaning or disinfecting. Damage may result. Use of cleaning/disinfecting agents other than isopropyl alcohol inside the patient cable connector and battery adapter tray can result in chemical residue build-up and damage to the contacts. Connecting the patient cable to the MX40 while there is still moisture from the cleaning/disinfecting agents other than isopropyl alcohol present, and then inserting the rechargeable battery or battery adapter tray and batteries into the MX40 can result in corrosion of the MX40 pins and patient cable contacts. Use of brushes with stiff and/or wire bristles on any part or component of the MX40 may cause damage. Cleaning Materials for the MX40 Cautions Use of abrasive cleaning materials, or disinfectants or cleaning agents not listed herein, on any part or component of the MX40 may damage the components. Sharp or pointed instruments should not be used to remove soil from recessed areas on the MX40. Note The cleaners listed in the following table have been tested and approved by Philips as of the print date of this document. Note The listed cleaners are also suitable for cleaning the outside of the patient cable, the rechargeable battery, and the outside surface of the battery adapter tray. 5-4 Maintenance Cleaning Approved Cleaners Cleaner Active Ingredient Isopropyl Alcohol Isopropyl Alcohol (>70%) Hydrogen Peroxide Hydrogen Peroxide (3%) Chlorine Bleach Sodium Hypochlorite (1:10 concentration, mixed <
24 hours) Metrex CaviWipes Isopropyl alcohol (15-18%) Sodium hydroxide (0.1%) 2-butoxyethanol (1-5%) Viraguard Isopropanol (70%) Resert XL HLD Hydrogen peroxide (1.4-2-3%) 2-Fumic Acid (<2.5%) Sporox II Sterilizing &
Disinfection Solution Hydrogen peroxide (7.5%) Phosphoric acid (0.85%) Sanicloth Plus Germicidal Cloths (Red Top) Isopropyl alcohol (55%) n-Alkyl dimethyl ethyl benzyl ammonium chlorides n-Alkyl dimethyl benzyl ammonium chlorides Quaternary ammonium (0.5%) WipesPlus Disinfecting Wipes Phenylphenol (0.28%), Benzyl-p-chlorophenol (0.03%) TechSpray General Purpose Cleaner Oxivir Tb Cleaner Disinfectant Isopropyl alcohol (70%) Hydrogen peroxide (2.5-3.5%) Oxivir Tb Wipes Hydrogen peroxide (3%) Sanicloth HB Quaternary ammonium (1%) Sanicloth Plus (Red Top) Quaternary ammonium (0.25%) 2-Butoxyethol (1-4%) Isopropyl alcohol (14.85%) Super Sanicloth (Purple Top) Quaternary ammonium (<1%) Isopropyl alcohol (55%) Sodium Hypochlorite (0.6%) Sanicloth Bleach Germicidal Disposable Wipes (Orange Top) Balcillol 25 Ethanol 100 mg/g, Propane-2-ol 90 mg/g Propane-1-ol 60 mg/g Maintenance 5-5 Cleaning Cleaner Bacillol AF Active Ingredient Propane-1-ol (450 mg/g) Propane-2-ol (250 mg/g) Ethanol (47 mg/g) Hydrogen Peroxide Hydrogen peroxide (5%) Meliseptol Propane-1-ol, (50 g) Glyoxal (0.08 g) Alkaspray Ultra Bis (3-aminopropyl) Dismozon Plus Biguacid Liquid ethanol (25 - 30 %) Dodecylamine (0.31 g) Didecyl dimethyl ammonium chloride (0.16 g) Benzalkonium chloride (0.03 g) Magnesium monoperoxyphthalate hexahydrate
(90%, 100%);
Tridecanol, branched, ethoxylated (1%, <2.5%);
Amines, coco alkyldimethyl, N-oxides(1%,
<2.5%);
(1 packet in 4 liters water, 0.4%) propan-2-ol (35 - 40 %) polyhexamethylene biguanide hydrochloride < 0.1
Lysoformin Formaldehyde (6%) Glutaral (1.8%)
(0.75% solution in water) Descosept pur Ethanol (45%) Descogen Liquid Pentakaliumbis (peroxymonosulfate) bis (sulphate
) > 1%
Unsupported Cleaners The following cleaners have been tested and failed. They should not be used to clean the MX40. Caltech-Dispatch 5200 Cidex Formula 7 Cidex Activated Dialdehyde Liquid Soap (antibacterial soap) Metricide Cidex OPA Gluteraldehyde Omnicide Sanicloth AF Wavicide Incidin Procide 14 Virex Tb 5-6 Maintenance Disposing of the MX40 Disposing of the MX40 Warning To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the MX40 appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories where not otherwise specified, follow local regulations regarding disposal of hospital waste. You will find detailed disposal information on the following web page:
http://www.healthcare.philips.com/main/about/Sustainability/Recycling/p m.wpd The Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium). Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered. Maintenance 5-7 Label Assignment for Replacement MX40 Label Assignment for Replacement MX40 During installation, an equipment label is assigned to each MX40 in a clinical unit so that the device can be identified during operation within the wireless system. If an MX40 is lost, the Assign Label function at the Information Center enables you to unassign the label from a lost device and re-assign its label to a replacement device. Labels are limited to those available in an individual clinical unit. Re-assigning an Equipment Label at the IntelliVue Information Center To re-assign an equipment label to a replacement device:
1. At the Information Center, clear the sector that the original equipment label was assigned to (Patient Window -> Sector Setup -> Clear Sector -> OK). Note Before clearing the sector, ensure that the equipment label of the lost device is not actively assigned to a patient being monitored. 2. Select All Controls -> Label Assignment. 3. Enter password (tele). Note The remaining screens will be in English only. Insert battery power into the MX40 and if attached, disconnect the patient cable. 4. 5. Select Refresh. 6. Select the MAC address of the replacement device from the New Devices list. If the address does not appear, remove battery power and re-insert. Select Refresh. Note The MAC address appears on the rear label of the MX40. 7. Select the equipment label that was assigned to the previous device from the 8. Select Assign Label to initiate programming of the equipment label into the Equipment Label list. replacement MX40. 9. When prompted, press Confirm on the MX40 to accept the assignment. The confirmation must occur within 30 seconds of the prompt. 10. Wait for the new device label to change to the selected equipment label. 11. In Sector Setup, select the Bed Label and Equipment Label and then press OK. 5-8 Maintenance Label Assignment for Replacement MX40 Re-assigning an Equipment Label at the IntelliVue Information Center iX To re-assign an equipment label to a replacement device:
1. Enter the Manage Unit application (scroll down if necessary). 3. Select the entry for both the previously assigned device (on the left) and the entry for the 2. Select Label Assignment. available device (on the right). 4. Select Replace. 5. At the MX40, select Confirm. 6. At the Information Center iX, select OK. 7. Select Refresh to confirm that the device now appears in the Assigned Devices column. 8. Confirm that the Equipment Label is now displayed on the MX40. Maintenance 5-9 Charging Lithium-ion Rechargeable Batteries Charging Lithium-ion Rechargeable Batteries The li-ion rechargeable battery is recharged using the IntelliVue CL Charging Station. In order to meet the published battery life specifications, the battery should be fully charge before use. Battery management is very important to ensure that when a fully charged battery is needed, one is available. Recharging a discharged battery can take up to 6.5 hours. To charge a battery, place it onto a charger slot on the charging station. The battery power indicators will supply information about the charge status. Warning Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the power supply to fit an ungrounded AC mains socket. Do not use AC mains extension cords or multiple socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits. Do not connect any devices that are not supported as part of the system. Battery Power Indicators There are various indications which help you keep track of the battery power status. LEDs on the charging station slots battery status information on both the MX40 and the charging station's display, and at the Information Center INOP messages The indicators always show the remaining capacity in relation to the battery's actual maximum capacity which may lessen as the battery ages. 5-10 Maintenance Charging Lithium-ion Rechargeable Batteries Charging Station LEDs The AC Power / Error LED is cyan during startup or to indicate a general charging station error green when the charging station is connected to AC power The nine Charger Slot LEDs show the battery status of the device in their slot and are switched off if a battery is not inserted. When a battery is put on a charging station slot, confirm that the corresponding LED flashes yellow until the battery's current state has been identified. Then a beep is issued, and the LED reflects the battery status as described in the table below. Status no battery on charger slot or battery inserted upside down. off battery put on charger slot and recognized flashing yellow battery not properly recognized, error battery recognized, battery charging battery recognized, battery full (>90%) LED cyan yellow green Note Wiping of battery contacts with an alcohol solution after cleaning is recommended. Battery Status on the Charging Station Display The IntelliVue CL Charging Station display provides a quick overview of all the connected devices and their battery status. The screen is arranged in the same layout as the charger slots. Note The display on the charging station is product revision dependent. Newer revisions do not have a display. Maintenance 5-11 Charging Lithium-ion Rechargeable Batteries Battery Lifetime Management The lifetime of a li-ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 500 complete charge-discharge cycles. Battery Disposal Discharge the battery and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations. 5-12 Maintenance 6. Part and Option Ordering Information This section provides specific part number, option number, support part number, and descriptive information associated with the MX40. MX40 Support Parts .................................................................................. 6-2 Part and Option Ordering Information 6-1 MX40 Support Parts MX40 Support Parts 1.4GHz Smart-hopping MX40 865350 (USA & Puerto Rico only) 6-2 Part and Option Ordering Information 2.4GHz Smart-hopping MX40 865351 MX40 Support Parts Part and Option Ordering Information 6-3 MX40 Support Parts 802.11 MX40 - 865352 6-4 Part and Option Ordering Information MX40 Support Parts Service personnel can find hardware service number, serial number
(outlined in yellow below) and MAC address information on the label on the back of the MX40:
Part and Option Ordering Information 6-5 7. MX40 Repair Strategy Repair choices for the Philips IntelliVue MX40 include: (1) Whole Unit Exchange, offered worldwide through Philips part centers and (2) repair through the Philips Lifecycle Support Center (Philips Repair Bench) for the US and Canada. MX40 repairs for both choices are completed by the Philips factory to the Philips production standards and meet all published specifications. Philips Healthcare has not qualified any third-party service providers to perform repairs on the IntelliVue MX40. Repair parts and certain accessories purchased from other vendors, except as noted in the MX40 Instructions for Use, are not controlled by the Philips Quality System, and may not meet Philips published specifications. Note Philips does not warrant third party hardware including repair hardware component upgrades; third party software including software upgrades; third party operating systems or operating system patches, fixes and updates. Tools Required ........................................................................................... 7-2 Software License Transfer ........................................................................ 7-3 MX40 Repair Strategy 7-1 Tools Required Tools Required Repair of the MX40 requires the following tools:
MX40 Service Adapter Cable PC running the IntelliVue Support Tool - Mark2 Internet Connection to the Philips Software License Server 7-2 MX40 Repair Strategy Software License Transfer Software License Transfer The MX40 uses software licensing functionality to track customer information, software revisions, and features enabled. Software Licensing allows Philips personnel to easily determine what products, features, and revisions are installed at a particular customer site. Exchange devices will arrive without a software license and will display a SW License Required message. The software license from the defective device needs to be transferred to the exchange device using the IntelliVue Support Tool - Mark2. For more information, see the Support Tool Instructions for Use that accompanied the Support Tool software. MX40 Repair Strategy 7-3 Software License Transfer Required information from defective device:
Original Ship To Address information (country, city) Notes on the MX40 Service Adapter and cable:
The service adapter is for service and demo use only. SW Serial Number, It is not to be used in the patient OR vicinity. HW Service Number and HW Serial Number
(see Pg. 6-5) It is not to be used to power the device when it is connected to a patient. The service adapter is installed in the battery compartment. The MX40 connects to the PC via a USB port, and uses a USB cable but the MX40 does not operate as a standard USB device. Maximum cable length = 3 ft (1m) Note The MX40 does not support the use of a cable longer than 3 ft. Longer cables may result in an unacceptable drop in voltage. 7-4 MX40 Repair Strategy Software License Transfer 8. Troubleshooting This section provides information about the technical alarms generated by the MX40 and associated troubleshooting suggestions. Also provided are troubleshooting suggestions for user interface issues and information regarding the patient cables used with the MX40. Technical Alarms (INOPs) ........................................................................8-2 Informational Messages ..........................................................................8-14 Possible User Interface Issues ................................................................8-22 WLAN Coverage Assessment (MX40 P/N 865352) .............................8-24 WLAN Troubleshooting .........................................................................8-31 Smart-hopping Troubleshooting ...........................................................8-34 Troubleshooting 8-1 Technical Alarms (INOPs) Technical Alarms (INOPs) Technical Alarms, or INOPs (inoperative conditions), are sourced at the MX40, the ST/AR algorithm running at the Information Center, or the IntelliVue Patient Monitor. They identify inoperative conditions (that is conditions where the system is not operating properly and therefore cannot measure or detect alarm conditions reliably). There are four levels of Technical Alarms:
Severe - Monitoring and alarm generation are disabled. Visual alarm indicator on the MX40. Audible tone at the Information Center. Must be acknowledged by a clinician. Hard - Monitoring and alarm generation are disabled. Visual alarm indicator on the MX40. Audible tone at the Information Center. Soft - Monitoring and alarms remain active. Visual alarm indicator on the MX40 and at the Information Center. No audible tones are generated at the Information Center Red/Yellow - Replace Battery, ECG Leads Off, and Leadset Unplugged INOPs may be configured to display as either Red or Yellow Technical Alarms. Note - The ECG Leads Off and Leadset Unplugged INOPs will initially display as a cyan technical alarm until a valid ECG signal is obtained. 8-2 Troubleshooting Technical Alarms (INOPs) Alarm Text Priority Condition What to do Cannot Analyze ECG Hard Source - MX40 and Information Center
(PIC iX only) Cannot Analyze QT Soft Cannot Analyze ST Soft Arrhythmia algorithm cannot reliably analyze the ECG data on any monitored leads. Assess the lead selections, initiate relearn, and validate analyzed rhythm. Check other INOPs for possible source of problem. The QT Arrhythmia algorithm cannot reliably analyze the QT data on any monitored leads. Change electrodes and/or electrode position. Change Primary lead. The ST Arrhythmia algorithm cannot reliably analyze the ST data on any monitored leads. Change electrodes and/or electrode position. Change Primary lead.
!! Check Pairing Source - MX40 and Information Center
(IIC only) Yellow Technical Alarm There is a problem with device assignment. Check that the bedside monitor or cableless measurement device is correctly assigned. Select the correct device to be assigned. When the MX40 is wirelessly assigned with an X2 patient monitor (no label) docked with a larger networked MP series monitor, the network connection is lost. The HR/Pulse alarm limit is set too high/low for the pulse measurement range CL NBP Pod is not connected with the MX40. Set alarm limit within pulse measurement range. Pulse rate measurement range = >
25bpm - < 240bpm (Masimo SET); > 30bpm - < 300bpm
(Philips FAST). Resolve interference condition. Reduce range between CL NBP Pod and MX40. CL NBP Pod empty battery condition. Monitoring is not possible. Replace CL NBP Pod. Recharge depleted CL NBP Pod. Chk PulseT Limits Hard Source - MX40 cl NBP Disconnect Hard Source - Cableless Measurement Device cl NBP Batt Empty Hard Source - Cableless Measurement Device Troubleshooting 8-3 cl SpO2 Batt Low Hard Charge CL SpO2 Pod. What to do Replace CL SpO2 Pod. Recharge depleted SpO2 Pod. Condition CL SpO2 Pod empty battery condition. Monitoring is not possible. CL SpO2 Pod weak battery condition. CL SpO2 Pod is not connected with the MX40. Resolve interference condition. Reduce range between CL SpO2 Pod and MX40. Cuff pressure has exceeded the specified safety limit. Remove cuff and tubing and expel air. ECG is turned off. This is normal behavior if operating in SpO2 only mode. Single lead is off. If primary lead is MCL, lead will be identified as V/C in INOP text. Multiple leads are off. Turn on ECG. Attach ECG/SpO2 patient cable. Re-attach ECG leads to patient. Re-attach ECG leads to patient. Technical Alarms (INOPs) Alarm Text cl SpO2 Batt Empty Priorit Hard Source - Cableless Measurement Device Source - Cableless Measurement Device cl SpO2 Disconnect Hard Source - Cableless Measurement Device Cuff Not Deflated Severe Source - Cableless Measurement Device ECG/Arrh AlarmsOff Soft Source - MX40
<ECG Lead>Lead Off Hard Source - MX40 ECG Leads Off Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Red or Yellow or Hard Technic al Alarm Source - MX40 8-4 Troubleshooting Alarm Text Invalid Leadset Source - MX40 Technical Alarms (INOPs) Priority Condition What to do Hard Replace with compatible leadset. Leadset Life Soft Replace with new leadset. Red or Yellow or Hard Technical Alarm Patient cable has been unplugged from the MX40. Re-attach the patient cable. Replace the leadset. Replace with compatible leadset. FAST SpO2 leadset attached to MX40 with Masimo SET option. Masimo SET leadset attached to MX40 with FAST SpO2.
(MX40 Revision dependent.) The single-patient use leadset has exceeded its limit of 25 cycles. Incompatible leadset attached to patient cable. Masimo leadset attached to MX40 with FAST SpO2. (MX40 Revision dependent.) Soft Change to Monitor Mode. There is no alarm audio notification when operating in Telemetry Mode. NBP Cuff Overpress Severe Cuff pressure has increased above overpressure safety limits. Remove cuff and tubing and expel air. Hard Tubing may be obstructed or kinked. Check tubing. If condition persists, contact Service. Hardware malfunction. Troubleshooting 8-5 Source - MX40 Leadset Unplugged Source - MX40 Note If supported by your revision of PIC iX, this INOP may also be configured to display as a Red or Yellow Technical Alarm. Note The message will initially display for up to 3 seconds as ECG Leads Off at the MX40 and at the PIC iX. Local Audio Off Source - MX40 Note This is normal operation in Telemetry Mode. Source - Cableless Measurement Device NBP Equip Malf Source - Cableless Measurement Device Technical Alarms (INOPs) Alarm Text NBP Interrupted Source -
CablelessMeasurement Device Source - Cableless Measurement Device No Alarm Display Soft Source - MX40 No Central Monit.
(appears at MX40 only) Source - MX40 Priority Condition What to do Hard The preset maximum time for the total measurement has been exceeded. Reduce patient movement and avoid interaction with the cuff and tubing. NBP Measure Failed Hard Attach cuff to new location Measurement values cannot be derived. on patient. Replace cuff. No local alarming at the MX40, networked or non-
networked. IIC - Configuration specific setting. PIC iX - Contact Service. Hard The MX40 is out of Return the MX40 to the range of the network. Patient Sector at the Information Center is in Standby. coverage area. Select Resume at the Information Center. No Host Monitoring Hard Source - MX40 The paired MX40/
bedside monitor is out of short-range radio range or there is excessive radio interference. Reduce the distance between the devices. Identify and remove interference source. No SpO2T, Batt Low Hard Battery power is too low to support SpO2 measurement. Insert fresh batteries to continue monitoring SpO2. Replace Battery Source - MX40 Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. This INOP configuration setting also affects the Tele Batt Empty INOP. Resp Equip Malf Source - MX40 To avoid loss of monitoring, replace batteries when this INOP is present. Red or Yellow or Hard Technical Alarm, Latched Disposable battery power is close to depleted. At least 10 minutes of monitoring time remains. Depending on your environment, you may see this message for several hours. Monitoring ceases immediately when batteries are depleted. Hard Contact Service. Malfunction in the Resp equipment. MX40 requires calibration. 8-6 Troubleshooting Technical Alarms (INOPs) Priority Condition What to do Hard Resp lead off. Re-attach lead to patient. Alarm Text Resp Leads Off Note OR leadsets cannot be used to monitor Resp with the MX40. Source - MX40 Some ECG AlarmsOff Soft For information only. Some ECG alarms have been turned off at the Information Center. Speaker Malfunct Soft Source - MX40
<SpO2 Label> Erratic Hard
(FAST SpO2 only) Source - MX40 The MX40 Power-on Self Test detected a speaker failure. Remove the MX40 from use. Contact Service. Repeat measurement, reposition sensor on patient, or finally, replace sensor. Erratic SpO2 measurements, often due to a faulty sensor or invalid SpO2 measurements, or incorrect transducer position
<SpO2 Label> Equip Malf Hard Malfunction in the SpO2 equipment Contact Service. Source - MX40
<SpO2 Label>
Extd.Update
(FAST SpO2 only) Numeric is displayed with a -?-. Source - MX40
<SpO2 Label>
Interference Source - MX40 Soft Hard The update period of displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. If NBP is not active, check the sensor placement. Reposition the sensor on patient, or replace sensor. Reduce ambient light to sensor or electrical noise sources. Level of ambient light or level of electrical interference are so high that the SpO2 sensor cannot measure SpO2 and pulse rate.
<SpO2 Label> Low Perf Soft Source - Monitor Accuracy may be reduced due to low perfusion. Data displayed with ?. Increase perfusion. Change sensor site. Avoid site distal to BP cuff or intra-arterial line. Warm the site. Troubleshooting 8-7 Technical Alarms (INOPs) Alarm Text Priority Condition What to do Pulse is too weak or not detectable. Check connection to patient.
<SpO2 Label> No Pulse Note For FAST SpO2 only this INOP may also be configured to display as a Red or Yellow Technical Alarm. Red or Yellow or Hard Technical Alarm Source - MX40
<SpO2 Label> No Sensor Hard No sensor attached to SpO2 device. Attach SpO2 sensor.
<SpO2 Label>
NoisySignal Source - MX40 Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Reduce movement or electrical noise sources.
<SpO2 Label> Poor Signal Soft Source - MX40 Although a measurement may be possible, its accuracy may be reduced due to poor signal quality. Apply the sensor according to the manufacturer's instructions. Relocate the sensor to a different site on the patient.
<SpO2 Label> Pulse?
Hard
(FAST SpO2 only) Source - MX40 The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. Check connection to patient. Avoid excessive motion at the measurement site. Warning Silencing this technical alarm turns off the SpO2 measurement on the MX40 and at the Information Center when operating in Manual or Continuous mode. It does not turn the measurement off when operating in Auto mode. Source - MX40 8-8 Troubleshooting Technical Alarms (INOPs) Alarm Text Priority Condition What to do
<SpO2 Label> Replc Cable Hard Yellow Hard condition - The connected SpO2 sensor cable is approaching expiration. (95%). Replace Masimo patient cable.
(Masimo SET SpO2 only) Note Depending on PIC iX revision, this may appear there as Unknown or !!Cable life. Contact Service to upgrade your PIC iX to the compatible revision. The MX40 will display !!
ReplcCable as expected. Source - MX40
<SpO2 Label>
ReplcSensor
(Masimo SET SpO2 only) Note Depending on PIC iX revision, this may appear there as Unknown or !!Sensor life. Contact Service to upgrade your PIC iX to the compatible revision. The MX40 will display !! ReplcSensor as expected. Warning Failure to replace the sensor when this condition is present will result in loss of SpO2 monitoring. Source - MX40 Replace sensor. Hard Yellow Technical Alarm Hard condition - the connected SpO2 sensor or adhesive life is approaching expiration.
(95%). Yellow alarm condition -
the connected SpO2 sensor or adhesive life has expired.
<SpO2 Label>Searching Soft Source - MX40 The patient signal is analyzed, but a valid numeric is not available yet. Wait for the measurement to complete. Troubleshooting 8-9 Technical Alarms (INOPs) Alarm Text Priority Condition What to do
<SpO2 Label> Sensor Off Hard Note The ability of the algorithm to detect this condition depends on the sensor type in use. The algorithm has determined that a sensor is connected, but not properly applied to the patient. Apply the sensor according to the manufacturer's instructions. If the condition persists, relocate the sensor to a different site on the patient.
<SpO2 Label> Sensor Malf Hard Malfunction of the SpO2 sensor/adapter cable Replace sensor and/or adapter cable. Hard Use specified sensor and/or adapter cable. Source - MX40
<SpO2 Label>
Unkn.Sensor Source - MX40
<SpO2 Label> Upgrade Soft
(FAST SpO2 only) Source
- MX40 Tele Batt Empty Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Source - MX40 Red or Yellow or Hard Technical Alarm, Latched The connected SpO2 sensor and/or adapter cable is not supported by the hardware version. SpO2 hardware is in upgrade process. SpO2Monitoring is not possible. Lithium-ion battery power is close to depleted. At least 10 minutes of monitoring time remains. Depending on your environment, you may see this message for several hours. Monitoring ceases immediately when battery is depleted. Wait for the upgrade process to complete. To avoid loss of monitoring, insert a charged lithium-ion battery pack when this INOP is present. Tele Battery Low Note This INOP may also be configured to display as a Red or Yellow Technical Alarm. Source - MX40 Hard or Soft based on Tele Batt Empty INOP configuration setting (cyan =
soft, red or yellow = hard). There is < 20 minutes of monitoring time remaining (AA batteries). Lithium-ion battery level is < 10% or has < 20 minutes remaining time. Replace batteries promptly to avoid shutdown and cessation of monitoring. Insert a charged lithium-ion battery pack. 8-10 Troubleshooting Technical Alarms (INOPs) Alarm Text Priority Condition What to do Tele Battery Temp Hard Note When the above INOP occurs, the Tele Batt Low INOP is suppressed. The temperature of the lithium-ion battery is above 55o C or below -5o C. Remove the current battery from patient use, replace the lithium-ion battery. Hard MX40 internal malfunction or self-test failure. Contact Service to replace the MX40. Tele Check Battery Soft Note When the above INOP occurs, the Tele Batt Low INOP is suppressed. Lithium-ion battery has <
25 charge cycles remaining before reaching the charge cycle maximum limit. Be aware that the Lithium-ion battery pack will soon need replacement. Hard, Latched The MX40 is outside the coverage area, or No batteries in the MX40 The MX40 is receiving a weak signal for > 10 seconds with high data loss from the AP, or The MX40 has failed. Make sure that the MX40 is within the coverage area and has good batteries. Replace the MX40 if Power On Self Test fails. Put bed in Standby. Refer to the additional Troubleshooting information that appears beginning on page. Hard, Latched The temperature of the lithium-ion battery is
>60o C and the battery must be removed. Remove the current battery from patient use, replace the lithium-ion battery. Dispose of old battery properly. Source - MX40 Tele Malfunction Source - MX40 Source - MX40 Tele No Signal (appears at the Information Center only) Note When operating with PIC iX, the INOP will display as No Data Tele. Source - Information Center Tele Remove Batt Note When the above INOP occurs all other battery related INOPs are suppressed. Source - MX40 Troubleshooting 8-11 Alarm Text Priority Condition What to do The lithium-ion battery has exceeded the maximum charge cycle limit and reached the end of its useful life. Replace the lithium-ion Dispose of old battery battery. properly. Tele Service Batt Hard Note When the above INOP occurs, the Tele Batt Low INOP is suppressed. Source - MX40 Tele Weak Signal Soft Source - MX40 Return patient to the coverage area. If patient is in close proximity to AP, replace the MX40. Contact service. The AP covering the specific area is suspect. Contact Service. Hard Reattach ECG leads to patient. Patient is at out of range of the radio coverage area. The MX40 is receiving a weak signal for > 6 seconds with high data loss from the AP. Condition may exist for multiple devices in a specific area RF Auto Shutoff after 10 minutes of all leads off, no SpO2 sensor connected, and no short-range radio communication. The MX40 (WLAN) is connected to the Access Point but cannot obtain an IP address. Unsupported LAN Hard Correct the IP address issue. Transmitter Off Source - MX40 Source - MX40 Troubleshooting 8-13 Informational Messages Informational Messages The following table lists the Informational Text messages that may appear in the Status Area of the MX40 display. Informational Text Condition What to do. Setting synchronized to Central The MX40 is returned to use and settings are synchronized to reflect any changes that may have occurred at the Information Center. Cleared after setting synchronization is complete. The message displays for a minimum of 30 seconds, depending on the number of settings changes. Check Revisions The revision of the Information Center that the MX40 is trying to connect to is not supported. Connect only to supported revisions of the Information Center. DEMO (flashing text) The MX40 is operating in Demo Mode. Cleared when the MX40 is changed to a different operating mode. Patient monitoring is not possible in Demo Mode. Measurements cannot be performed, and alarms cannot be communicated. Remove and reinsert the battery to resume patient monitoring. CONFIG (flashing text) The MX40 is operating in Configuration Mode. Cleared when the MX40 is changed to a different operating mode. Incompatible Option Masimo SET or FAST SpO2 device configured with wrong option. Cleared automatically after temporary display. SERVICE (flashing text) The MX40 is operating in Service Mode. Cleared when the MX40 is changed to a different operating mode. Patient monitoring is not possible in Service Mode. Measurements cannot be performed, and alarms cannot be communicated. Remove and reinsert the battery to resume patient monitoring. SRR Started Cleared automatically. No OR-ECG leadset connected Continues to flash as a reminder while the leadset adapter is in use. Cleared when adapter is removed from MX40. Resp Avail Cleared automatically after one minute. Short-range radio is powered on (used with Cableless Measurement Devices and when paired to a patient monitor). IntelliVue Patient Monitor leadset adapter is in use. This message is a reminder not to use OR-ECG leadsets with the adapter. User confirms that an OR-ECG leadset is not attached with the adapter. Resp not available The Resp feature is not enabled. SpO2 not available SpO2 sensor is connected to MX40 but the device does not have the SpO2 option enabled/available. Software option must be installed to enable Resp. Enable MX40 software option/upgrade hardware. Switch to Masimo SET Leadset Incorrect leadset is connected to Masimo device. Cleared automatically after connecting Masimo leadset. 8-14 Troubleshooting Informational Messages Informational Text Condition What to do. Switch to Philips FAST Leadset Incorrect leadset is connected to Philips FAST device. Cleared automatically after connecting Philips FAST leadset. SRR Network Scan Cleared automatically when complete. SRR Channel <chan num>
Cleared automatically after selection. SRR Searching Sensor Cleared automatically. Short-range radio channel scan in progress. Short-range radio channel scan is complete and best channel is selected. Short-range radio is attempting to associate with Cableless Measurement Devices. Short-range radio is in power saving mode and no longer searching for Cableless Measurement Device until the Add/Remove SmartKey is touched again SRR Stopped Cleared automatically or when the Add/Remove SmartKey is touched. cL NBP Assigned Short-range radio is assigned to an NBP Cableless Measurement Device. Cleared automatically after one minute. cL SpO2 Assigned Short-range radio is assigned to an SpO2 Cableless Measurement Device. Cleared automatically after one minute. SRR Searching Monitor Short-range radio is attempting to associate with a patient monitor. Cleared automatically. SRR Assoc Monitor Short-range radio is connected to a patient monitor. Cleared automatically. SRR Link Test Short-range radio link testing is in progress before final association. Cleared automatically. Icon replaces message. SRR Unavailable w/ Resp Respiration monitoring is enabled, therefore the Short-range radio is disabled. Turn the Resp parameter off at the Information Center. Troubleshooting 8-15 Additional Hardware Troubleshooting Information Additional Hardware Troubleshooting Information Problem Condition What to do. The following icon is displayed on the MX40:
865352 802.11 MX40 does not operate, just displays this icon. The 865352 MX40 cannot use AA batteries. It will only operate with the Philips MX40 Li-ion battery. Remove the AA batteries and battery adapter and replace with a Philips MX40 Li-ion battery. There is damage to a battery contact in the MX40 battery compartment, and the MX40 cannot recognize that a Philips MX40 Li-ion battery is installed. The MX40 will require replacement via the Exchange Process, or for USA and Canada only, repair (at the Philips Lifecycle Support Center). Failure of the Philips Li-ion battery. Replace the battery. 8-16 Troubleshooting Additional Hardware Troubleshooting Information MX40 Reboots Intermittently Device reboots intermittently, possibly when bumped or tapped. This may be caused by wear, corrosion, or damage to the:
Check the battery. If there is damage and/or corrosion of the battery contacts, replace the battery. Battery Contacts AA Battery Adapter Tray Chemical residue buildup on the contacts in the AA battery adapter tray Corrosion of the contacts in the AA battery adapter tray Separation of the flex circuit from the AA battery adapter tray plastic body Battery Compartment Contacts Chemical residue buildup on the battery contacts in the battery compartment Corrosion of the battery contacts in the battery compartment Separation of the battery contacts from the silicone membrane in the battery compartment Loss of battery contacts from the silicone membrane in the battery MX40 Battery Retention Tabs damage or breakage of the tabs results in battery or battery adapter movement during operation Check the AA battery adapter tray for wear/damage (indentations) in the contacts, and for wear/separation of the flex circuit from the tray and corrosion of the flex circuit contact areas. Replace battery adapter as necessary. Check battery compartment and contacts for damage/ corrosion. Once corrosion to the battery contacts and/or damage to the bond between the silicone membrane and the battery contacts occurs the MX40 cannot be repaired in the field. The MX40 will require replacement via the Exchange Process, or for USA and Canada only, repair (at the Philips Lifecycle Support Center). CAUSES:
Improper cleaning/disinfection of the MX40 and AA battery adapter tray, and/or use of unapproved cleaning and disinfecting agents can cause the above noted issues, specifically:
Failure to remove the battery adapter tray from the battery compartment for cleaning/disinfecting allows chemical to collect and dry under the battery adapter tray, which results in residue build up, contact corrosion, and damage to the bond between the silicone membrane and the battery contacts, especially when bleach is used Use of unapproved cleaning and disinfecting agents (can damage the silicone membrane, causing failure of the bond to the battery contacts and corrosion to the battery contacts) Improper application of cleaning and disinfecting agents like soaking the battery adapter tray and battery compartment (can lead to corrosion of the contacts in the AA battery adapter tray and separation of the flex circuit from the AA battery adapter tray plastic body) Failure to wipe the MX40 and battery adapter tray with a cloth dampened with either distilled water or Isopropyl Alcohol to remove chemical residue following disinfection (causes Troubleshooting 8-17 Additional Hardware Troubleshooting Information Problem Condition What to do. chemical residue build-up, corrosion, and separation over time) The MX40 will require replacement via the Exchange Process, or for USA and Canada only, repair (at the Philips Lifecycle Support Center). 8-18 Troubleshooting Problem Visible corrosion of patient cable connector pins either on the MX40 or on the patient cable Additional Hardware Troubleshooting Information Condition Visible corrosion (black and/or green) Visible loss of gold plating from the pin(s) Visible chemical residue buildup on the pins Inability of the MX40 to communicate with the patient cable (Leadset Unplugged technical INOP) Inability of the MX40 to acquire ECG and/or SpO2 signals (ECG Leads Off, and/or SpO2T No Sensor technical INOPs) What to do. Once corrosion of the pins on the MX40 has occurred, it cannot be effectively removed or corrected. The device will require replacement via the Exchange Process, or for USA and Canada only, bench repair (at the Philips Lifecycle Support Center). Once corrosion of the contacts on the patient cable connector has occurred, the patient cable will need to be replaced. CAUSES:
Improper cleaning/disinfection of the patient cable and/or the MX40, and/or use of unapproved cleaning and disinfecting agents can cause the noted issues, specifically:
Application of disinfecting products other than Isopropyl Alcohol inside the connector on the patient cable can result in corrosion and/or chemical residue build-up Application of product other than Isopropyl Alcohol inside the connector on the patient cable, followed by connection to the MX40 while there is still fluid inside the patient cable connector, and then insertion of batteries into the device, will cause a reaction between the base metals of the contacts. This then results in corrosion to both the MX40 connector pins and patient cable connector contacts Application of bleach inside the connector on the patient cable results in corrosion and residue build-up on the contacts. Troubleshooting 8-19 Additional Hardware Troubleshooting Information Problem Shorter run time than specified in the IFU. Condition AA batteries Philips rechargeable Lithium-ion battery The clinical use model will impact the battery life. Confirm the use model. Use models that can significantly impact battery run time include the following:
Use model: ECG only operation with an ECG+SpO2 device Use model: ECG+SpO2 Continuous Use of the short-range radio Use of the display Use of Monitor Mode Operating the device off network
(display turns on automatically). What to do. Use fresh / high quality AA batteries. NOTE: The battery life specifications are based on the use of three fresh Duracell MN 1500 batteries. Battery life for other brands may differ. Ensure that the battery is fully charged before being put into the device. The battery capacity of rechargeable batteries degrades over time and number of recharge cycles. Toward the end of its useful life, the battery capacity may be reduced by 25-30%. Check the charge cycles of the battery in Service Mode. Check the age by looking at the date code on the battery itself. When operating an ECG+SpO2 device in ECG only mode, ensure that the SpO2 Mode is set to Manual. Even if the SpO2 parameter is not displayed on the device or Information Center, if the Mode is set to Continuous, the SpO2 PCA is operational, and will draw a significant amount of energy resulting in a shorter than expected run time. When operating in SpO2 Continuous mode, SpO2 monitoring will stop, but ECG monitoring will continue after the MX40 initiates a No SpO2T, Batt Low INOP message. When ECG monitoring is no longer possible, a No Signal INOP message will appear at the Information Center. Specifications are provided for both states, and are significantly different. Use of the short-range radio can reduce battery life by 25%. Use of the display consumes a significant amount of power. Display is being turned on frequently (by user or patient) Change the MX40 to Telemetry Mode. Device is going off network frequently, which also turns display on. Extend the coverage of the wireless network or restrict the patients to the covered area. 8-20 Troubleshooting Additional Hardware Troubleshooting Information Problem Cyan LED at charging station slot Condition Rechargeable battery cannot establish What to do. communication with charger Leave the battery on the charging station for up to 30 hours to allow the battery to begin to communicate with the charging station. If communication has been established, the LED will be either Yellow indicating that the battery is charging, or Green, indicating that charging is complete. If after 30 hours, the charging slot LED is still Cyan, replace the battery. Causes:
Battery is in an over-discharged state as a result of being left in the MX40 device after power down Battery was in storage and was not properly maintained during the storage period. Battery has failed. Troubleshooting 8-21 Possible User Interface Issues Possible User Interface Issues The MX40 display does not turn on. The AA Battery Tray may be inserted backwards. The user may not understand that they need to touch the blue Main Screen button for two seconds. The MX40 display is on but does not react to touch. The screen is locked and needs to be unlocked using the Unlock SmartKey. a. Select the Smartkey button. b. Scroll to the second page. c. Select the Lock/Unlock Smartkey. 8-22 Troubleshooting Possible User Interface Issues The user is not using their finger to touch the screen. The MX40 does not react to touches by a fingernail, pen, etc. The MX40 does not recognize the patient cable type. The IntelliVue style leadset adapter cable is being used, therefore, detection of the cable type is not possible. Configure the MX40 for the desired settings:
ECG Cable Color, using the Configuration Menu in Configuration Mode. Lead Placement, using the HR Menu in Configuration Mode. If using a 3-wire IntelliVue leadset, it must be selected using the Setup ECG menu and then selecting the New Lead Setup entry. This will remove the INOP message. Troubleshooting 8-23 Coverage Assessment Coverage Assessment For MX40 devices, use the following procedure to confirm that the RF coverage of the wireless network meets the requirements of the MX40 for the performance level for clinically safe operation. Measurements are focused in patient care areas where patients spend the majority of their time (patient room, patient bathroom). Additional measurements are suggested for traditionally difficult coverage locations where monitored patients will be (in procedure areas, patient transport corridors (frequent roaming) and elevators, etc.). During the procedure, the MX40 is worn on the body to more closely simulate the normal use model. The RF signal strength will be impacted by the body. If the test criteria are not met, remediation is required. Signal strength remediation may include:
moving access points adding access points Interference remediation may include:
removing the source of the interference changing the frequency of operation Assessment Mode Using Assessment Mode, you can determine coverage levels of typical locations within the hospital, e.g. patient rooms and hallways. 1. Turn the MX40 on. 2. Press the SmartKeys button. 3. Select the Op Modes SmartKey. 4. From the Operating Modes menu, select Service and enter the password. 5. Use the scroll bar to navigate to the second page of the Service menu. 6. Select clear CAV data and confirm. 7. Scroll to the second page again and select Assessment Mode. 8. From the Assess Coverage Menu, select the Room button to choose Room, Hallway, or Other. 8-24 Troubleshooting Coverage Assessment 9. Use the numbered keypad to enter location identification. 10. Select the location from within the room, e.g. Bed, to begin the 11. While the assessment is measuring the RSSI Value Field will display 12. Once complete, the RSSI Value and Link Quality Indicator fields will assessment. alternating dashes. populate. 13. To end the assessment at any time, press the blue Main Screen button. If there is more than one bed in a room, select the + key to make additional measurements associated with the selected room. When all measurements are complete, use the arrow keys to advance to the next room. Link Quality Assessment Indicator Values Link Quality Smart-hopping LQI Indicator Color Link Quality Average Retries
/ 25 Seconds Average RSSI / 25 Seconds (body blocked) Coverage Status LQI=4 Avg. Retries <
50 Good
> -67 dBm
(1.4GHz)
> -68 dBm
(2.4GHz) LQI=3 Avg. Retries >
50 to 125
> -70 dBm to > Weak Signal Threshold Marginal Avg. Retries >
125
< Weak Signal Threshold Insufficient NoteThe measurement criteria listed above is for MX40 Hardware Rev. B.01.01 or greater. NoteThe Link button on the Assess Coverage menu is for future use and not presently active. Troubleshooting 8-25 Coverage Assessment Link Quality - WLAN NoteWLAN Link Quality & Rssi assessment with B.05 or greater with HW rev.C.01.01 or greater. NoteFor deployment in the 5GHz band, only use the A-865350-90304-5GHz-WLAN CAV template. NoteThe Link button on the Assess Coverage menu is for future use and not presently active. Coverage Assessment Data Coverage Assessment data can be exported from the MX40 using the IntelliVue Support Tool Mark 2. A zip file is created containing a coverage.txt file. Renaming the file to coverage.csv allows it to be imported into a comma delimited spreadsheet. Spreadsheet template files can be found on InCenter (A-865350-90222-1G4CAV 1.4GHz, A-865350-90223-
2G4CAV 2.4GHz, A-865350-90304WLAN, and A-865350-90306-WLAN). Stored coverage data survives power cycling. Stored coverage data is viewable in Assessment Mode. Stored data is not affected by changes in Operating Mode. 8-26 Troubleshooting Coverage Assessment Stored coverage data is deleted in Service Mode. Select Clear CAV Data. When confirmed, the stored coverage data is erased from flash memory. The total FMID is 12 bits. (The last 10 bits of the IP address and 2 bits to define remote antennas and Core AP.) To export Coverage Assessment data:
1. Select the appropriate device. 2. Select the Configuration/Report Tab. 3. Select Collect Device Data. 4. Deselect the Collect Full Data checkbox. 5. Save the file to the desired directory location. Data Format Smart-hopping Radio Room Number Location, RSSI 1... RSSI 6, LQI 1... LQI 6, FMID 1... FMID 6, Retry 1Retry 6 (LQI is 0 to 4 and FMID is decimal), Room Number Location (room#, hallway#, other#). For WLAN devices, the AP MAC address is provided. Example 1: 0,0,-59,-59,-58, , , ,4,4,4, , , ,3.164,3.164,3.164 RA1, , ,5,0,2, , , (, , is blank data) Example 2: 0,0,-59,-59,-58,-45,-47,-50,4,4,4,4,4,4,3.164,3.140,3,142, 3.142,3,142,10,0,5,5,0,0 The graphics below are examples of an Excel spreadsheet and summary for coverage assessment data with a 1.4GHz Smart-hopping radio. Troubleshooting 8-27 Coverage Assessment Information from the data tab maps to the summary tab as shown below. RSSI Retries SQI FMID 8-28 Troubleshooting Optionally, coverage area verification measurements can be performed using the MX40 along with the AirSpy tool. Status Parameters The tables below lists the WLAN Status Parameters and their associated definitions/settings. Access is through Service Mode or by touching the wireless icon in the Status Area while in Monitoring mode. The Status Parameters can then be viewed by touching the Link Quality area on the Device Status menu. Use the Status Parameter information to determine connection quality. Note Interference is indicated by a poor Link Quality Indicator reading and an excessive number of Retries while RSSI is at an adequate value. Smart-hopping Link Information Definition/Setting Received Signal Strength Indicator (moving average over 5 seconds). Reported in dBm (decibel-milliwatts). See Signal Strength table below Link Quality Indicator Radio link quality relates to RSSI and Retries This retry number represents the number of retries over the last second. Signal Quality Indicator (SQI) = 0-4 This field reports the last 10 bits of the IP address of the Access Point the MX40 was previously/currently connected to. Coverage Assessment Smart-hopping Link Information Definition/Setting Conn. Status Current wireless network connection status RF Access Code Retries*
MAC Info Network Info RSSI Rate Retries SQI Wireless LAN Conn. Status Retries*
Active Channel Mode WMM Mode SSID Security Mode MAC AP WLAN WLAN Link Information Definition/Setting Seeking: MX40 has Smart-hopping radio on and is looking for an Access Point Locked: MX40 has located an Access Point Active: MX40 has an active connection to an Access Point Inactive: MX40 has Smart-hopping radio turned off The RF Access Code of the MX40, which must match the RF Access Code of the system it is intended to connect to. Retries since last reboot. The MAC address of the MX40 Smart-hopping radio. IP Address, Subnet Mask, Default Gateway, Server IP Received Signal Strength Indicator (moving average over 3 seconds) Currently selected transmit rate (adapts dynamically based on wireless signal propagation behavior) Radio link quality relates to RSSI and Retries Retries over last 3 seconds. Signal Quality Indicator (SQI) = 0-4 On, Off Current wireless LAN connection status (None, Scanning, Authenticating, Associating, Connected, Link Problem) Retries since last reboot. Current radio channel 802.11ah, 802.11bg, 802.11g Wireless Multi-Media On, Off - support Quality of Signal
(QoS) over WLAN The Service Set Identifier in use - Network Name Display selected security mode The MAC address of the access point to which a connection has been established Troubleshooting 8-29 Coverage Assessment 802.11n MAC Address Network Info Multicast WLAN Link Information Definition/Setting On, Off The MAC address of the MX40 WLAN radio IP Address, Subnet Mask, Default Gateway, Server IP
(Server IP - IP address of the PC server. If not entered
(0.0.0.0) the address of the DHCP server, if any, is substituted) Multicast address being used for the CI (Connect Indication) message. Regulatory Domain Country definition as determined by system configuration. 8-30 Troubleshooting General Troubleshooting General Troubleshooting Normal Start-up Process 1. MX40 performs self-test. 12. 13. 14. MX40 begins local monitoring. MX40 establishes connection to Smart-hopping network. MX40 establishes connection with IntelliVue Information Center. Status Checks 1. Check status at the Information Center.
- Ensure MX40 equipment is assigned to a sector.
- Check for INOP messages in the sector. 15. Check status of MX40.
- Check for INOP messages.
- Check Device Status area icons for basic status.
- Navigate to Link Info screen for more detailed information if necessary. Troubleshooting 8-31 WLAN Troubleshooting WLAN Troubleshooting Problem Possible Cause Solution MX40 fails to connect to Surveillance PIIC iX. MX40 display inop No Central Monitor and Connection Status is in state None. Status indicates that the MX40 does not have a network connection, or a radio association to the Access Point. There are several possible causes for this including:
AP not turned on, or not connected to customer-supplied infrastructure properly. Verify the AP is powered on and connected to the customer-supplied infrastructure properly. MX40 is not configured for the correct 802.11 radio modality for the SSID setup (802.11a, 802.11bg, 802.11abg). MX40 not configured for the correct SSID. It must be the same as configured on the WLAN Controller. MX40 not configured for the correct WPA/WPA2 pre-shared key. It must be the same as configured on the WLAN Controller. MX40 is not seeing strong enough signals. Check the configuration of the MX40 and verify modality is configured. After the MX40 settings have been set via the IntelliVue Support Tool, make sure settings are confirmed to ensure the settings are retained. Check the configuration of the MX40 and verify that the correct, case-
sensitive SSID is configured. Also check the configuration of the SSID on the WLAN Controller. After the MX40 settings have been set via the Support Tool, make sure settings are confirmed to ensure the settings are retained. Check the configuration of the MX40 and verify that the correct WPA or WPA2 pre-shared key is configured. Check the configuration of the WPA/WPA2 key on the WLAN Controller. The default pre-shared key must not be used. Deploy additional Aps or adjust AP power levels to accommodate the required signal strength. 8-32 Troubleshooting WLAN Troubleshooting MX40 was cloned and wireless settings were lost. Configure the MX40 with the correct settings: SSID, WPA key, radio modality. MX40 not configured for the correct country code. Do not change the MX40 country code from its default setting (1000). The default setting causes the MX40 to use the country code provided by the AP to which it associates. Defective MX40. If MX40 self-test fails:
Verify issue persists with other MX40s. If so, verify CSCN WLAN settings. If all settings are correct, replace MX40. MX40 fails to connect to Surveillance PIIC iX. MX40 has a radio connection to the wireless infrastructure but has not been recognized by the Surveillance PIIC iX. Possible causes include:
MX40 not assigned to Surveillance PIIC iX. No Monitor Label assigned to MX40 from Surveillance PIIC iX. Assign MX40 to the Surveillance PIIC iX from the Surveillance PIIC iX. Configuration problem using WEP, WPA (PSK), WPA (PSK), or 802.1x Authentication. Verify the Mode, SSID, Country and Security settings in the MX40 match your installation. Configuration problem using WPA Enterprise or WPA2 Enterprise including 802.1x Authentication Check the connection status. (Status messageConn.Status). I the state only shows Scanning, make sure that the Mode, SSID, Country, and Security settings in the MX40 Status screen are accurate. If not, correct the configuration using the IntelliVue Support Tool. Troubleshooting 8-33 WLAN Troubleshooting 8-34 Troubleshooting Check the connection status. If the MX40 shows the state Authenticating, the SSID, Mode, Country and Security settings are correct. If a WLAN connection to the Access Point is established, but the MX40 fails to authenticate, check the authentication server and WLAN controller error logs. As an investigation step, disable the CertificateCheck via the IntelliVue Support Tool (Configuration
->Hardware>Network->WLAN). If authentication is now possible, proceed with the step below. Otherwise, verify the authentication server configuration, WLAN controller configuration and the user credentials (User Name, Password, Anonymous Identity). If the previously used credential settings were incorrect, the MX40 may be on the exclude list of the WLAN Controller. Resolve the issue on the WLAN Controller. Note:
Remember to re-enable the certificate check. Check the installed CA certificate using the IntelliVue Support Tool (Task-
>Clone from Medical Device) Open the cloned file using Configuration->Configuration Editor. In Configuration Editor check Configuration->Hardware
->Network->WLAN->Certificate 1 for validity (Valid from, Valid until) Make sure that the installed CA certificate is the root certificate of the authentication server certificate chain. 9. MX40 WLAN (P/N 865352) This section provides information specific to the operation of the WLAN version of the MX40. Important MX40 WLAN (865352) requires compliance with Phillips Customer-supplied Clinical Network Specifications. The 865352 IntelliVue MX40 802.11 a/b/g/n is a Wi-Fi CERTIFIED product (Certification ID: WFA63551). For additional information, visit https://www.wi-fi.org/product-finder-
results?sort_by=certified&sort_order=desc&keywords=MX40&companies=21 Short-range Radio and WLAN ................................................................ 9-2 WLAN Configuration Parameters .......................................................... 9-3 MX40 WLAN (P/N 865352) 9-1 Short-range Radio and WLAN Short-range Radio and WLAN Because at least 20 MHz separation is needed between the SRR channels and 802.11b/g/n (2.4 GHz ISM band) channels in order to source real-time waves over the SRR link, the MX40 WLAN device should only be used with Short-range radio when operating on the 802.11a (5 GHz) band. See Smart-
hopping and SRR Channel Selection for 2.4GHz Smart-hopping Networks p. 2-17. 9-2 MX40 WLAN (P/N 865352) WLAN Configuration Parameters WLAN Configuration Parameters The MX40 WLAN configuration is loaded into the MX40 using the IntelliVue Support Tool - Mark2 (IVST Mark2). The parameter values are changed using the IntelliVue Support Tool Configuration Editor which is accessed from the IVST Mark2 "Configuration/Report" tab. The WLAN parameters can be found under:
Hardware > Network Hardware > Wireless > Wireless Hardware > Wireless > WLAN Hardware > Network Parameter Comments Available Selections WLAN IP Config Enabled On, Off Mode DHCP, Manual The MX40 only supports DHCP. Must be On for WLAN connection to function. CI Config 1 CI Mode CI Address X.X.X.X IP Address Configuration QoS State On, Off Broadcast, Unicast, Multicast, Off Standard operation is Multicast, Broadcast and Unicast are not recommended. 224.0.23.63 or224.0.23.173 for Multicast To enable QoS, this must be configured On, and WMM Mode on the WLAN page must be set to Enabled. QoS Level 0-7 A level of 6 is recommended. Hardware > Wireless > Wireless Parameter Comments Available Selections Wireless Network Off, On Wireless Adapter WLAN, IIT Must be On for WLAN connection to function Must be WLAN for WLAN connection to function. MX40 WLAN (P/N 865352) 9-3 WLAN Configuration Parameters Hardware Wireless WLAN Applicable to MX40 Available Selections Comments WMM Mode Yes Disabled, Enabled Security Mode Yes To enable QoS, this must be set to
"Enabled", and QoS State on the Network menu page must be set to
"On". WPA2-Enterprise is not recommended due to increased handover times. 802.11 ah is recommended. WEP, WPA (PSK), WPA2 (PSK), WPAEnterpr, WPA2Enterpr Auto, 802.11ah, 802.11bg, 802.11g
1-32 characters WEP Key Index Yes 1, 2, 3, 4 This selects which WEP Key will be used. 104 Bit, 40 Bit
104 Bit, 40 Bit 104 Bit, 40 Bit 104 Bit, 40 Bit 10 or 26 hex characters based on Key Size 1,2,3,4,5,6,7,8,9,A,B,C,D,E,F 10 or 26 hex characters based on Key Size 1,2,3,4,5,6,7,8,9,A,B,C,D,E,F 10 or 26 hex characters based on Key Size 1,2,3,4,5,6,7,8,9,A,B,C,D,E,F 10 or 26 hex characters based on Key Size 1,2,3,4,5,6,7,8,9,A,B,C,D,E,F WPA Password Yes
8-63 characters WPA (PSK) / WPA2 (PSK) WPA Enterprise / WPA2 Enterprise Authentication Yes NotConfigrd, PEAP, TTLS If WPA / WPA2 Enterprise is selected, must select PEAP or TTLS. 9-4 MX40 WLAN (P/N 865352) Parameter General Mode SSID WEP WEP Key Size 1 WEP Key 1 WEP Key Size 2 WEP Key 2 WEP Key Size 3 WEP Key 3 WEP Key Size 4 WEP Key 4 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes WLAN Configuration Parameters Parameter Applicable to MX40 Available Selections Comments Inner Authentication Yes The MX40 only supports MSCHAPv2. PEAP Version PEAP Label Certificate Check User Name Password Anonymous Identity Certificate 1 Friendly Name CA Certificate File Size Valid from Valid until Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes NotConfigrd, PAP, CHAP, MSCHAP, MSCHAPv2 Default, Version 0, Version 1 Default, EAP, PEAP Disabled, Enabled Should be "Enabled" is using a certificate. "Disabled" is provided for troubleshooting purposes. 0-63 characters 0-63 characters 0-63 characters 0-32 characters Add, Delete Not modifiable, reflects file chosen Not modifiable, reflects file chosen Not modifiable, reflects file chosen
WLAN Configuration Parameter Definitions Hardware > Network Parameter Definitions These definitions are for the parameters that apply to the MX40. WLAN IP Config these are parameters that apply specifically to the wireless network adapter.
"Enabled" under the WLAN IP Config section refers to the wireless network adapter in the MX40. When "Enabled" is configured "on" the wireless network adapter is on and active. When configured "Off", the wireless network adapter is in a low power sleep state.
"Mode" under the WLAN IP Config section refers to the network configuration protocol the device uses when communicating over the 802.11 link. Although other selections may be available on the IntelliVue Support Tool Configuration Editor, the only network configuration protocol that the MX40 supports is DHCP. MX40 WLAN (P/N 865352) 9-5 WLAN Configuration Parameters CI Config 1 these parameters apply to the MX40 once the data reaches the wired network. CI Mode - Standard operation is Multicast. Broadcast and Unicast are not recommended CI Address - 224.0.23.63 or 224.0.23.173 for Multicast IP Address Configuration these parameters apply to the MX40 once the data reaches the wired network QoS State: In order to enable Quality of Service for the MX40 data once it reaches the wired network, the "QoS State" parameter must be configured "On", and the "QoS Level" must be configured for a value greater than "0". Note: "WMM Mode" on the "WLAN" page must be configured for "Enabled" otherwise this setting will be ignored by the MX40. QoS Level: "QoS Level" sets the network QoS priority that the MX40 will use to tag packets. The QoS Level is used for both the wired and the wireless link. "0" is the lowest priority, "7" is the highest priority. A QoS Level of "6" is recommended for the MX40. Hardware > Wireless > Wireless Parameter Definitions These definitions are for the parameters that apply to the MX40. Wireless Network Must be On for WLAN connection to function. Wireless Adapter Must be On for WLAN connection to function. Hardware > Wireless > WLAN Parameter Definitions General WMM Mode This parameter enables or disables WMM (Wireless Multimedia Mode). Used for basic wireless quality of service. Note: "QoS State" on the
"Network" page must be configured "On" and the "QoS Level" must be configured for a value greater than "0" otherwise this setting will be ignored by the MX40. Security Mode WEP, WPA(PSK) or WPA2(PSK), WPA-Enterprise and WPA2-
Enterprise with either Protected EAP (PEAP) or Tunneled TLS (TTLS) as authentication methods. WPA2 (PSK) is recommended. WPA2-Enterprise is not recommended due to increased handover times (roaming). WEP is not recommended due to general security issues. 9-6 MX40 WLAN (P/N 865352) WLAN Configuration Parameters SSID WEP WEP Key Index Service Set Identifier: Logical WLAN Network Name. Defines the transmit WEP Key Index. This entry must match the WEP Key Index configured at the infrastructure device, i.e. on a WLAN Access Point, and ranges from 1 to 4. WEP Key Size WEP Key The WEP Key Size 40 bit or 104 bit The number of hex characters for the WEP key depends on the WEP key size chosen. For a 40 bit WEP key size the WEP key must be 10 hexadecimal characters long, for a 104 bit key the WEP key must be 26 hexadecimal characters long. WPA WPA Password In WPA(PSK) or WPA2(PSK) mode this entry defines the Pre-Shared-
Secret or Password with 8 to 63 alpha-numeric characters. WPA Enterprise / WPA2 Enterprise In WPA-Enterprise or WPA2-Enterprise mode the following parameters are used:
Authentication The authentication method can be either Protected EAP (PEAP) or Tunneled TLS (TTLS). Inner Authentication For the MX40, PEAP and TTLS can only be used with MSCHAPv2 as the Inner Authentication method. PEAP Version This setting describes the PEAP protocol version to be used while authenticating against the authentication server. Valid values are Default, Version 0 and Version 1. If set to Default the decision is up to the wireless adapter. Version 0 or 1 forces the wireless adapter to use the protocol version required for a certain authentication server. This setting is intended for experts only. PEAP Label MX40 WLAN (P/N 865352) 9-7 WLAN Configuration Parameters The PEAP label setting defines the string to be used to signal EAP-
PEAP encryption to the authentication server. Valid values are Default, EAP or PEAP. Default leaves the decision up to wireless adapter. Both EAP and PEAP force the wireless adapter to use this setting. This setting is intended for experts only. Certificate Check As long the Certificate Check is set to Enabled, the CA Certificate is used to verify the authenticity of the certificate chain delivered by the authentication server. The verification involves also the system time to check the validity period of every certificate in the chain. This item can only be set to Enabled, if a CA Certificate has been installed. Valid values are Disabled or Enabled. Username Password The username used in the encrypted tunnel with 1-63 alpha-numeric characters. It is also used as outer identity as long as the Anonymous Identity is not set. The password used in the encrypted tunnel with 8-63 alpha-numeric characters. Will be shown as four stars "****" after the user entered the password. Anonymous Identity The identity used for the outer PEAP or TTLS authentication, which may be "unprotected". Thus, the identity should be different to the Username for enhanced security. The Anonymous Identity contains 1-63 characters. It can be set to NotConfigured by clearing it. Certificate 1 Friendly Name A certificate can be installed on the MX40, and when doing so, a
"Friendly Name" of up to 32 characters can be assigned to it. 9-8 MX40 WLAN (P/N 865352) MX40 WLAN Device Specific Performance Characteristics MX40 WLAN Device Specific Performance Characteristics In addition to the network requirements covered in the IntelliVue Clinical Network Specification, the MX40 has the following device specific performance characteristics:
DTIM In order to preserve battery life, the MX40s 802.11 Listen Interval is hardcoded to three beacon intervals or roughly 300ms (based on a typical access point beacon period of 100 TUs). This means that the MX40 will wake up approximately every 300ms to receive beacons and data. The access point (AP) honors the MX40s Listen Interval, buffering unicast traffic destined for the MX40 for the time period specified by the Listen Interval. Please note: The Listen Interval configuration does not affect when data is transmitted by the MX40 to the Information Center. It only affects when the MX40 will come out of power-save mode to receive messages. The AP beacon contains the DTIM (Delivery Traffic Indication Map) period. The DTIM indicates how often an AP will send broadcast and multicast messages to all clients on a WLAN. For example, a DTIM Period of 1, indicates broadcast and multicast messages are sent after every beacon. A DTIM Period of 2 indicates broadcast and multicast messages are sent after every second beacon. The MX40 does not follow the DTIM (Delivery Traffic Indication Map) period announced in the AP beacon frames. If broadcast or multicast messages (e.g. ARP) are being sent to the MX40s every beacon period (DTIM = 1, every 100ms or so), but the MX40 only comes out of power-save mode every 300ms (approximate), then the MX40 will miss some of these broadcast / multicast messages. This can lead to sluggish response to ARP or other broadcast / multicast protocols. There are several approaches to deal with problems resulting in the MX40 failing to respond to ARP messages in a timely fashion:
Make static ARP entries for the MX40s on the router, so that their ARP entry does not expire. Eliminate the need for routing by mapping the Philips SSID to the same subnet as the Information Center. MX40 WLAN (P/N 865352) 9-9 MX40 WLAN Device Specific Performance Characteristics 9-10 MX40 WLAN (P/N 865352) 10. Safety Standards &
Specifications This section describes the regulatory standards that the IntelliVue MX40 complies with, along with product and measurement specifications. Regulatory Information .......................................................................... 10-2 Electromagnetic Compatibility.............................................................. 10-9 Battery Specifications ............................................................................ 10-15 Lithium-ion Battery Charge Time ....................................................... 10-18 Physical Specifications .......................................................................... 10-19 MX40 1.4 GHz Smart-Hopping Radio ................................................ 10-20 MX40 2.4 GHz Smart-Hopping Radio ................................................ 10-21 MX40 Short-Range Radio ..................................................................... 10-22 MX40 2.4GHz WLAN Radio ................................................................ 10-23 Environmental Specifications .............................................................. 10-27 Measurement Specifications ................................................................ 10-28 Safety Standards & Specifications 10-1 Regulatory Information Regulatory Information Software Hazard Prevention Potential hazards arising from errors in the software program have been identified. Mitigations applied to reduce the associated risk of such hazards are included as part of the Risk Management, Clinical Evaluation, and Verification and Validation phases of the products development. AC Power Source The system is not intended for connection to the public mains as defined in CISPR-11. Industrie Canada Compliance (Canada) This Class B ISM device complies with Canadian ICES-001. Cet ISM de la classe B est conforme la norme NMB-001 du Canada. Safety Standards The device complies with the following safety requirements for medical electrical equipment:
EN 60601-1:2006 +A1: 2013, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 + A1: 2012 EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1:1988 + A1:1991 + A2:1995 EN ISO80601-2-49:2018 Medical electrical equipment Part 2: Particular CAN/CSA C22.2 601.1-M90: Medical Electrical Equipment part 1: General requirements for Safety requirements for Safety UL 60601-1 Medical Electrical Equipment - General Safety EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-1:2000 10-2 Safety Standards & Specifications Regulatory Information EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2007 EN 60601-1-2:2001+ A1:2006, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:2001 +A1:2004 EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-2:2014 ISO 80601-2-61:2017 Pulse Oximeters, requirements for SpO2 EN 80601-2-61:2019 Pulse Oximeters, requirements for SpO2 EN 60601-1-4: 1996 + A1:1999 Medical electrical equipment - Part 1-4:
General requirements for safety - Collateral standard: Programmable electrical medical systems IEC 60601-1-4:1996 + A1:1999 EN 60601-1-6:2007, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2004 EN 60601-1-8: 2004 +A1: 2006, Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-1-8: 2003 + A1: 2006 EN 60601-1-8: 2007 IEC 60601-1-8: 2006 EN 60601-2-27: 2006, Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60601-2-27: 2005 EN 60601-2-27: 2011 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment IEC 60602-2-27: 2011 Safety Standards & Specifications 10-3 Regulatory Information EN 60601-2-49: 2001, Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60601-2-49: 2001 EN 60601-2-49: 2011 Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment IEC 60602-2-49: 2011 EN ISO 10993-1:2009 (for leadwires and pouch), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN 62304:2006, Medical device software - Software life-cycle processes EN 62366:2008, Medical devices - Application of usability engineering to IEC 62304:2006 medical devices IEC 62366:2007 Intended Use Statement Intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals. Indications for Use Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. Intended Uses of MX40 The MX40 is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center. 10-4 Safety Standards & Specifications Regulatory Information The MX40 can provide time-limited local monitoring when it is not connected to the wireless network. Unlike a traditional bedside monitor which operates on AC power, the MX40 is powered by battery and cannot provide continuous monitoring. Authorized EU Representative Philips Medizin Systeme Deutschland Hewlett-Packard-Strasse 2 D 71034, Boeblingen Germany Authorized Australia Sponsor Philips Electronics Australia 65 Epping Road North Ryde NSW, Australia 2113 Patient Population This device is not for use with infant or neonatal patients. Clinical judgment must be used to determine when the MX40 should be used on a specific pediatric patient, as it is not possible to assign a precise weight or age to ECG performance. Use of the device is restricted to one patient at a time. The components/accessories which come into contact with the patients skin are in compliance with the relevant requirements of EN ISO 10993-1 for Biocompatibility. The device is not designed for direct contact with the patients skin. The accompanying pouch is the appropriate means for holding the device. Rx Contraindications Federal Law restricts this device to sale by or on the order of a physician. A Contraindication describes a situation, such as patient population, medical reason, or clinical condition, in which a device may not be used because the risk of use clearly outweighs any possible benefit. There are no contraindications for use of the MX40. Safety Standards & Specifications 10-5 Regulatory Information Essential Performance The IntelliVue MX40 provides Essential Performance (EP) under normal operating conditions (includes EMC exposure) only as a complete Medical Electrical System, consisting of the MX40, MPx companion monitor
(Optional), IntelliVue CL SpO2 and NBP Cableless Measurement devices(Optional), IntelliVue Telemetry Network Infrastructure, and the Information Center. The System achieves its Essential Performance exclusively through alarm generation at the IntelliVue Information Center and locally at the MX40, based on configuration. The IntelliVue MX40 protects the patient from unacceptable immediate clinical risk by generating specific Physiological Alarms when appropriate. If the system cannot generate Physiological Alarms, then relevant Severe or Hard-Level Technical Alarms (Inops) are created. Risk Management Considerations Warning The MX40 operates exclusively via a wireless network connection, therefore, it should not be used for primary monitoring in applications where momentary loss of the ECG is unacceptable at the Information Center. It sends ECG and optionally pulse oximetry and respiration data to the Information Center, where the Information Center displays real-time patient data, provides alarm annunciation, data storage and review applications. The ECG waveform data, alarms and optionally SpO2 and Resp can always be viewed on the MX40 regardless of the connection to the Information Center. Smart Hopping technology alleviates most of the problems associated with legacy telemetry technologies. Reception problems are less frequent, because Smart Hopping avoids interference and moves to a different access point if the signal strength is too low. The level of radio frequency activity is always fluctuating in the environment. If the level becomes high enough to significantly interfere with transceiver operation, the system responds by moving to another "cleaner" area where there is less activity. 10-6 Safety Standards & Specifications Dropouts Regulatory Information Because the MX40 operates exclusively via a wireless network connection, under certain frequency conditions dropouts can occur. Dropouts result from a weak signal or RF interference, and appear on the waveform when the signal is interrupted. If dropouts are frequent enough to affect the heart rate count, the "Cannot Analyze ECG" or "Cannot Analyze ST" technical alarm occurs. If there are enough dropouts to cause disassociation/reassociation with the Information Center, events in the Clinical Review application can reflect loss of data for up to 1 minute in the worst case. Monitoring Considerations Patient should be restricted to the designated coverage area. Monitoring performance will degrade if patients go outside the radius of coverage of the receiving wireless network. A patient location strategy is critical to a telemetry system. If a life-
threatening event occurs, the clinician must be able to locate the patient quickly. The importance of this increases as the coverage area increases. Frequency management is the responsibility of the hospital. Philips Healthcare has no control over the RF environment in the hospital. If interference exists at the operating frequencies of the telemetry equipment, telemetry performance will be affected. Careful selection of frequencies for all wireless devices used within a facility (transceivers, other wireless medical devices, etc.) is important to prevent interference between them. Caution IEC/ANSI/AAMI 80001-1:2010 Philips recognizes the importance of a safe and effective network that meets both the business needs of a healthcare facility, IT networking requirements, and the clinical functionality. Philips supports the IEC 80001-1 standard in regards to working as a partner with a healthcare organization in the design, implementation, and management of the Medical IT-Network to properly provision and support not only Philips devices, but all the devices using the network. Applying the principles of risk management to hospital frameworks is highly encouraged. When operating the MX40 on a Customer Supplied Clinical Network, Philips strongly encourages our customers to perform risk management of their Medical IT-Network infrastructure in accordance with IEC 80001. Changes may include changes in network configuration, connection of additional items, disconnection of items, update of equipment, or upgrade of equipment. Safety Standards & Specifications 10-7 Regulatory Information If the MX40 experiences loss of network connectivity, technical alerts at the Information Center ("No Signal" or "No Data Tele") and at the MX40 ("No Central Monitor") will occur. The MX40 will also automatically revert to local monitor mode which activates display of patient data on the MX40 however, when in this state, battery life will be shortened. 10-8 Safety Standards & Specifications Electromagnetic Compatibility Electromagnetic Compatibility Medical electrical equipment can either generate or receive electromagnetic interference. This product has been evaluated for electromagnetic compatibility (EMC) with the appropriate accessories according to IEC 60601-
1-2, the international standard for EMC for medical electrical equipment. This IEC standard has been adopted in the European Union as the European Norm, EN 60601-1-2. Radio frequency (RF) interference from nearby transmitting devices can degrade performance of the product. Electromagnetic compatibility with surrounding devices should be assessed prior to using the product. Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of medical equipment. See your service provider for assistance with the minimum recommended separation distance between RF communications equipment and the product. The cables, sensors/transducers, and other accessories for which compliance is claimed are listed in the Service and User documentation accompanying the product. Warnings The use of accessories, transducers and cables other than those specified in the product service and user documentation can result in increased electromagnetic emissions or decreased immunity of the product. Short-range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, and DECT phones. Outside the frequency band and 5% above and below, i.e. the exclusion band according to IEC 60601-1-2, the short-range radio connection is immune up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. Any interruption of the signal due to interference, moving out of range, or for other reasons is indicated with a Tele Disconnected INOP message. The product should not be used next to or stacked with other equipment. If you must stack the product, you must check that normal operation is possible in the necessary configuration before the product is used on patients. Safety Standards & Specifications 10-9 Electromagnetic Compatibility Note For cellphone frequencies 810-930 MHz at 28 V/m, increased ECG waveform noise is observed that impacts ST performance. The MX40 can tolerate RF interference power to 7 V/m and maintain ECG noise in compliance with IEC 60601-2-27 and AAMI EC13, and a typical cellphone RF power is expected to be less than 5 V/m. A technical alarm for ST or Invalid Parameter is presented with excessive ECG noise. Field strength is measured at 3 meter distance per standard. Reducing Electromagnetic Interference The MX40 and associated accessories can be susceptible to interference from other RF energy sources and continuous, repetitive, power line bursts. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmission. If interference is encountered, as demonstrated by artifact on the ECG or dramatic variations in physiological parameter measurement values, attempt to locate the source. Assess the following:
Is the interference due to misplaced or poorly applied electrodes or sensors? If so, re-apply electrodes and sensors correctly according to directions in Chapter 6. Is the interference intermittent or constant?
Does the interference occur only in certain locations?
Does the interference occur only when in close proximity to certain medical electrical equipment?
Once the source is located, attempt to attenuate the interference by distancing the MX40 from the source as much as possible. If assistance is needed, contact your local service representative. Restrictions for Use Artifact on ECG and other physiological waveforms caused by electromagnetic interference should be evaluated by a physician or physician authorized personnel to determine if it will negatively impact patient diagnosis or treatment. 10-10 Safety Standards & Specifications Electromagnetic Compatibility Electromagnetic Compatibility (EMC) Specifications Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Portable and mobile radiofrequency (RF) communications equipment can affect medical electrical equipment. Accessories Compliant with EMC Standards All accessories listed in the accessories section comply, in combination with the MX40, with the requirements of IEC 60601-1-2. Warning Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment. Electromagnetic Emissions Emissions Test Compliance Radio Frequency (RF) emissions Group 1 Avoiding Electromagnetic Interference TheMX40 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. RF emissions CISPR 11 Class B The MX40 is suitable for use in all establishments. Harmonized emissions Not Applicable Device is battery powered only Voltage fluctuations/Flicker emissions IEC 61000-3-3 Not Applicable Safety Standards & Specifications 10-11 Electromagnetic Compatibility Electromagnetic Immunity The MX40 is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below. Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge
(ESD) IEC 61000-4-2 6 kV contact 8 kV air 4th Edition:
+8 kV contact
+15 kV air 6 kV contact 8 kV air Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 4th Edition:
30 A/m 3 A/m Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency magnetic fields should be a t levels characteristic of a typical location in a typical commercial and/or hospital environment Recommended Separation Distance Warning The MX40, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements. In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Portable and mobile RF communications equipment should be used no closer to any part of the MX40, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. 10-12 Safety Standards & Specifications Electromagnetic Compatibility Interference may occur in the vicinity of equipment marked with this symbol:
Immunity Test IEC 60601-1-2 Test Level Compliance Level Conducted RF IEC 61000-4-6 3 Vrms 3 VRMS 150 kHz to 80 MHz 6 Vrms in ISM bands Radiated RF IEC 61000-
4-3 3 V/m 80 MHz to 2.7 GHz 3 V/m See Note under Electromagnetic Compatibility on page 10-
10. Electromagnetic Environment Guidance Recommended separation distance:
d = 1.2P Recommended separation distance:
80 MHz to 800 MHz d = 1.2P 800 MHz to 2.5 GHz d = 2.3P Field strengths from fixed transmitters, such as base stations for radio
(cellular, cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the monitor is used exceeds the applicable RF compliance level above, the MX40 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the monitor. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The MX40 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the monitor as recommended below, according to the maximum output power of the communications equipment. In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Safety Standards & Specifications 10-13 Electromagnetic Compatibility Frequency of Transmitter Rated max. output power of transmitter 0.01 W 0.1 W 1 W 10 W 100 W 0.1 m 0.4 m 1.2 m 3.8 m 12.0 m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Equation d = 1.2P d = 1.2P d = 2.3P Separation distance Separation distance Separation distance 0.1 m 0.4 m 1.3 m 3.8 m 12.0 m 0.2 m 0.7 m 2.3 m 7.3 m 23.0 m Electrosurgery Interference/Defibrillation/Electrostatic Discharge The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. Measurement accuracy may be temporarily decreased while performing defibrillation. This does not affect patient or equipment safety. Do not expose the equipment to x-ray or strong magnetic fields (MRI). The MX40 is not for use during electrosurgery. Restart Time After power interruption, an ECG wave will be shown on the display after 30 seconds maximum. 10-14 Safety Standards & Specifications Battery Specifications Battery Specifications Battery Life Note Battery life specifications are stated with a 95% confidence level that the average run time will be at least this long assuming a random sample of the population with a student-t distribution. The battery life specifications listed below are based on the use of three Duracell MN 1500 batteries. Battery life for other brands may differ. Telemetry Mode Networked
(Display Off) Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) ECG Only 37.0 hours 33.0 hours ECG/SpO2 FAST Continuous (ECG operation available.) 22.0 hours
(time to No Signal INOP) 20.0 hours
(time to No Signal INOP) ECG/SpO2 FAST Continuous (Continuous SpO2 operation available.) 10.0 hours
(time to No SpO2T, Batt Low INOP) 10.0 hours
(time to No SpO2T, Batt Low INOP) ECG/SpO2 Masimo Continuous (ECG operation available.) 20.0 hours
(time to No Signal INOP) 18.0 hours
(time to No Signal INOP) ECG/SpO2 Masimo Continuous (Continuous SpO2 operation available.) 9.0 hours
(time to No SpO2T, Batt Low INOP) 8.0 hours
(time to No SpO2T, Batt Low INOP) ECG/SpO2 FAST Auto (5 min.) (ECG operation available.) 35.0 hours 30.0 hours
(time to No Signal INOP)
(time to No Signal INOP) ECG/SpO2 FAST Auto (5 min.) (SpO2 operation available) 18.0 hours 16.0 hours
(time to No SpO2T, Batt Low INOP)
(time to No SpO2T, Batt Low INOP) ECG/SpO2 Masimo Auto (5 min.) (ECG operation available.) 30.0 hours 28.0 hours
(time to No Signal INOP)
(time to No Signal INOP) ECG/SpO2 Masimo Auto (5 min.) (SpO2 operation available) 15.0 hours 14.0 hours
(time to No SpO2T, Batt Low INOP)
(time to No SpO2T, Batt Low INOP) ECG/SpO2 Manual (FAST and Masimo) In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Safety Standards & Specifications 10-15 Battery Specifications Monitor Mode Networked
(Display On) ECG Only ECG/SpO2 FAST Continuous ECG/SpO2 Masimo Continuous Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) 10.5 hours 5.3 hours 9.5 hours 2.5 hours 4.3 hours 3.5 hours ECG/SpO2 Manual (FAST and Masimo) In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Monitor Mode Non-networked
(Display On) ECG Only ECG/SpO2 FAST Continuous ECG/SpO2 Masimo Continuous Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) 6.8 hours 4.7 hours 6.0 hours 4.0 hours 4.0 hours 3.0 hours ECG/SpO2 Manual (Fast and Masimo) In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. The battery life specifications listed below are based on the use of the Philips Rechargeable Lithium-ion battery. Telemetry Mode Networked
(Display Off) Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) Battery Life
(WLAN p/n 865352) ECG Only 30.0 hours 28.0 hours 28.0 hours ECG/SpO2 FAST Continuous (ECG Operation available) 15.6 hours (time to No Signal INOP) 14.0 hours (time to No Signal INOP) 15.0 hours (time to No Signal INOP) ECG/SpO2 FAST Continuous (Continuous SpO2 Operation available) 12.0 hours (time to No SpO2T, Batt Low INOP) 11.0 hours (time to No SpO2T, Batt Low INOP P) 12.0 hours (time to No SpO2T, Batt Low INOP) ECG/SpO2 Masimo Continuous (ECG Operation available) 12.5 hours (time to No Signal INOP) 11.0 hours (time to No Signal INOP) 12.5 hours (time to No Signal INOP) ECG/SpO2 Masimo Continuous (Continuous SpO2 Operation available) 10.0 hours (time to No SpO2T, Batt Low INOP) 9.0 hours (time to No SpO2T, Batt Low INOP P) 10.0 hours (time to No SpO2T, Batt Low INOP) 10-16 Safety Standards & Specifications Battery Specifications Telemetry Mode Networked
(Display Off) Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) Battery Life
(WLAN p/n 865352) ECG/SpO2 FAST Auto (5 min.) (ECG operation available) 28.0 hours (time to No Signal INOP) 26.0 hours (time to No Signal INOP) 27 hours (time to No Signal INOP) ECG/SpO2 FAST Auto (5 min.) (SpO2 operation available) 15.0 hours (time to No SpO2T, Batt Low INOP) 14.0 hours (time to No SpO2T, Batt Low INOP) 15.0 hours (time to No SpO2T, Batt Low INOP) ECG/SpO2 Masimo Auto (5 min.) (ECG operation available) 24.0 hours (time to No Signal INOP) 22.0 hours (time to No Signal INOP) 24 hours (time to No Signal INOP) ECG/SpO2 Masimo Auto (5 min.) (SpO2 operation available) 13.0 hours (time to No SpO2T, Batt Low INOP) 12.0 hours (time to No SpO2T, Batt Low INOP) 13.0 hours (time to No SpO2T, Batt Low INOP) ECG/SpO2 Manual (FAST and Masimo) In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Monitor Mode Networked
(Display On) ECG Only ECG/SpO2 FAST Continuous ECG/SpO2 Masimo Continuous Monitor Mode Non-networked
(Display On) ECG ECG/SpO2 FAST Continuous ECG/SpO2 Masimo Continuous ECG/SpO2 Manual Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) Battery Life
(WLAN p/n 865352) 10.0 hours 8.0 hours 9.0 hours 7.0 hours 10.0 hours 8.0 hours 7.0 hours 6.0 hours 7.0 hours ECG/SpO2 Manual (FAST and Masimo) In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Battery Life
(1.4GHz p/n 865350) Battery Life
(2.4GHz p/n 865351) Battery Life
(WLAN p/n 865352) 9.0 hours 8.0 hours 8.0 hours 7.0 hours 9.0 hours 8.0 hours 7.0 hours 6.0 hours 7.0 hours In this mode battery life is dependent on the usage rate and will range between the ECG Only battery life and the ECG/SpO2 Continuous battery life. Note Use of the short-range radio can reduce battery life by 35%. Safety Standards & Specifications 10-17 Battery Specifications Note The battery capacity of re-chargeable batteries degrades over time and number of recharge cycles. Toward the end of its useful life, the battery capacity may be reduced by 30%. If this reduced battery life is unacceptable based on your use model, Philips recommends replacing the rechargeable battery sooner. Nominal Current Operating Mode ECG Only FAST (Display inactive) ECG/SpO2 FAST Continuous
(Display inactive) ECG Only Masimo (Display inactive) ECG/SpO2 Masimo Continuous
(Display inactive) Nominal Current
(p/n 865350) Nominal Current
(p/n 865351) Nominal Current
(p/n 865352) 51.5 mA @ 3.6V 51.0 mA @ 3.6V 51.5 mA @ 4.1V 120 mA @ 3.6V 116 mA @ 3.6V 120 mA @ 4.1V 51.5 mA @ 3.6V 51.0 mA @ 3.6V 51.5 mA @ 4.1V 122 mA @ 3.6V 118 mA @ 3.6V 123 mA @ 4.1V Lithium-ion Battery Charge Time Definition Charging Method Battery pack charge time from 90%
depletion state The Lithium-ion Battery Pack is charged on a separate external charging station. It must be removed from the MX40 to charge. Charge Time 6.5 hours 10-18 Safety Standards & Specifications Physical Specifications Physical Specifications Parameter Height Width Depth SpO2 Weight Without batteries, includes With 3 AA batteries, includes SpO2 and all hardware options With lithium-ion battery, includes SpO2 and all hardware options Display Type View Area Resolution Backlight ECG Display Sector Size
(height) Speed Resp Display Sweep Speed Specification 126.8 mm (4.99 in) 69.9 mm (2.75 in) 31.5 mm (1.24 in) 1.4 GHz - 223 g (7.8 oz) 2.4 GHz - 223 g (7.8 oz) WLAN - 206 g (7.3 oz) 1.4 GHz - 298 g (10.5 oz) 2.4 GHz - 298 g (10.5 oz) 1.4 GHz - 289 g (10.2 oz) 2.4 GHz - 289 g (10.2 oz) 2.4 GHz/5.6 GHz WLAN - 274 g (9.7 oz) 2.8" QVGA Color LCD 43.2mm x 57.6 mm (1.70" x 2.26") 240 x 320 White LED 13.5mm (portrait), 9.9mm (landscape) or pleth data (portrait), 10mm/s with 5.76 sec of viewable ECG or pleth data
(landscape) or 25mm/s with 1.73 sec of viewable ECG or pleth data (portrait), 25mm/s with 2.30 sec of viewable ECG or pleth data
(landscape). 2.5mm/s with 17.28 sec of viewable RESP data (portrait) 2.5mm/s with 23.04 sec of viewable resp data (landscape). ECG or Pleth Display Sweep 10mm/s with 4.32 sec of viewable ECG Alarm Signal Sound Pressure Level 40dB(A) - 70dB(A) Safety Standards & Specifications 10-19 MX40 1.4 GHz Smart-Hopping Radio MX40 1.4 GHz Smart-Hopping Radio Parameter Specification Frequency Ranges Bands: 1395-1400 MHz and 1427-1432 MHz Channel Spacing: 1.6 MHz RF Output Power 12.5 dBm +/- 1.5 dB (12.6 mW to 25 mW, nominal 17.8mW) into antenna load. Calibrated into 50 Ohms Radio Frequency Accuracy during normal operation
<+60/-100 KHz relative to channel frequency, includes temperature compensation and aging effects Modulation Type GFSK (1M40Q7D)
<-41 dBm in 1 MHz bandwidth for FCC limit Out of Band Spurious Emission Levels:
<= 1394 MHz, >= 1401 MHz
<= 1428 MHz, >= 1433 MHz Occupied bandwidth as defined by power in 99%
BW
< +/- 800 KHz 1.4GHz WMTS (US only) This device complies with Part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. 10-20 Safety Standards & Specifications MX40 2.4 GHz Smart-Hopping Radio MX40 2.4 GHz Smart-Hopping Radio Parameter Specification Frequency Range ISM Band: 2400 - 2483.5 MHz Channel Assignment 48 radio channels assigned from 2401.056 MHz
- 2482.272 MHz RF Output Power Channel Spacing: 1.728 MHz FCC: Channels 0-46 -17 dBm +/- 1 dB (40 mW to 63 mW, nominal 50 mW), into antenna load. Channel 47 only - 15 dBm +/- 1 dB. ETSI: 12 dBm +/- 1 dB (13 mW to 20 mW, nominal 16 mW), into antenna load ARIB: 13.5 dBm +/- 1 dB (18 mW to 28 mW, nominal 22 mW), into antenna load Radio Frequency Accuracy during normal operation
<+ 60 /- 100 KHz relative to channel frequency, includes temperature compensation and aging effects Modulation Type GFSK, Gaussian Frequency Shift keying
(1M40Q7D) Modulation Bandwidth Typically 1.4 MHz (20 dB Bandwidth) Out of Band Spurious Emission Levels Typically 980 KHz (6 dB Bandwidth) Meets ETSI, RSS-210, FCC, ARIB standards 2.4 GHz ISM See page 10-24 for FCC Radio Compliance and page 10-24 for Industry Canada Radio Compliance. Safety Standards & Specifications 10-21 MX40 Short-Range Radio MX40 Short-Range Radio Parameter Specification Frequency Ranges ISM Band: 2400-2483.5MHz Radio Channel assignment 16 Radio Channel assigned, Fc= 2405 +5*(k-11) MHz, k=11,12,,26 Frequency Control RF Output Power Configured via the bedside monitor or the Information Center depending on use model.
-1.5 to -4.5 dBm +2/-3dB (0.7 mW to 0.3 mW), into Antenna load. MX40 Frequency Accuracy during normal operation
<+/-40ppm, includes temperature compensation &
aging effects Modulation Type Direct Sequence Spread Spectrum (DSSS), O-QPSK with half sine pulse shaping modulation (1M40Q7D) Modulation Bandwidth
>500KHz, typically +/-950KHz (6dB Bandwidth), typically +/-1.4MHz (20dB Bandwidth) 10-22 Safety Standards & Specifications MX40 2.4 GHz WLAN Radio MX40 2.4 GHz WLAN Radio The MX40 2.4GHz/5.6GHz WLAN Radio conforms to the 802.11 a/b/g/n standard operating in the 2.4GHz and 5.6GHz ISM bands. Note For the MX40 WLAN device, Part Number 865352, use of the MX40's short-range Radio is only supported when operating with 802.11a (5.6GHz band). The Radio characteristics are defined below. WLAN Radio RF Specs Specification 802.11b Technology Frequency Range 2.4 to 2.4835GHz IEEE 802.11 b Transmitter Power 10 to 15 dBm into antenna load (RMS power) Modulation CCK (Complementary Code Keying) Occupied Bandwidth, 99%
<-22 MHz 802.11g, 802.11ng Technology IEEE 802.11 g, 802.11 ng Frequency Range 2.4 to 2.4835GHz Transmitter Power 9.5 to 15 dBm into antenna load (RMS power) Occupied Bandwidth, 99%
<-22 MHz Modulation Type OFDM (Orthogonal Frequency Division Multiplex) Frequency Bands (802.11 b/g) FCC, RSS-210, ETSI Japan{ARIB},China, AS/NZS: 2.400 2.4835GHz Meets ETSI, RSS-210, FCC, ARIB, AS/NZS standards Out of Band Emissions (802.11 b/g) 802.11a, 802.11na Technology IEEE 802.11a, 802.11na Frequency Power 5.15 to 5.825GHz Transmitter Power 7 to 15 dBm into Antenna load (RMS power) Occupied Bandwidth 19 MHz (802.11a, 802.11na) 37 MHz (802.11na bonded channel) Modulation DSSS : OFDM (Orthogonal Frequency Division Multiplex) Frequency Bands (802.11a, 802.11na) FCC, RSS-210: 5.15 ~ 5.25Ghz, 5.25 ~ 5.35Ghz, 5.42 ~
5.725Ghz, 5.725 ~ 5.825Ghz (excluding 5.6 ~5.65GH ETSI, AS/NZS: 5.15~ 5.35Ghz, 5.47 ~ 5.725Ghz Japan, ARIB: 5.150 5.250GHz, 5.25 5.35GHz, 5.470 5.725GHz, China: 5.725 ~5.825Ghz Safety Standards & Specifications 10-23 MX40 2.4 GHz WLAN Radio WLAN Radio RF Specs Specification Out of Band Emissions
(802.11a, 802.11na) Meets ETSI, RSS-210, FCC, ARIB, AS/NZS standards FCC Radio Compliance This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference.
(2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Healthcare may cause harmful radio frequency interference and void your authority to operate this equipment. The device for band 5150-5250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. Industry Canada Radio Compliance The 865351 and 865352 devices contain license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas license-exempt RSS(s). Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired operation of the device. The 865350 device complies with RSS-210 of Industry Canada. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference
(2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Healthcare may cause harmful radio frequency interference and void your authority to operate this equipment. The maximum antenna gain permitted (for devices in the 5250-5350 MHz and 5470-5725 MHz bands) complies with the e.i.r.p. limits as stated in RSS-210. 10-24 Safety Standards & Specifications MX40 2.4 GHz WLAN Radio The maximum antenna gain permitted (for devices in the 5725-5825 MHz bands) complies with the e.i.r.p. limits specified for point-to-point operation as stated in RSS-210. Caution High power radars are allocated as primary users of 5250-5350 MHz and 5650-5850 MHz. These radars could cause interference and/or damage to LE-
LAN devices. Conformit aux exigences de la norme Industrie Canada en matire de radiofrquences Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :
1) Lappareil ne doit pas produire de brouillage 2) Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Ce dispositif est conforme la norme RSS-210 dIndustrie Canada. Son fonctionnement est soumis aux deux conditions suivantes : (1) ce dispositif ne doit pas gnrer dinterfrences perturbatrices et (2) ce dispositif doit accepter toute interfrence reue, y compris celles susceptibles de provoquer un fonctionnement indsirable. Tout changement ou modification apport cet quipement sans lapprobation expresse de Philips Healthcare peut gnrer des interfrences radio nuisibles et entraner lannulation de votre habilitation utiliser cet quipement. Le gain dantenne maximum autoris (pour les dispositifs fonctionnant sur les bandes 5 250-5 350 MHz et 5 470-5 725 MHz) est conforme aux limites PIRE (puissance isotrope rayonne quivalente) spcifies par la norme RSS-210. Le gain dantenne maximum autoris (pour les dispositifs fonctionnant sur les bandes 5 725-5 825 MHz) est conforme aux limites PIRE (puissance isotrope rayonne quivalente) relatives au fonctionnement point point spcifies par la norme RSS-210. Safety Standards & Specifications 10-25 Les radars de grande puissance sont attribus en priorit aux bandes 5 250-5 350 MHz et 5 650-5 850 MHz. Ces radars peuvent occasionner des interfrences et/ou des dommages aux dispositifs LE-LAN. MX40 2.4 GHz WLAN Radio Attention 10-26 Safety Standards & Specifications Environmental Specifications Environmental Specifications Parameter Specification Temperature Operating 0 to 37o C (32 to 99o F) Storage and Transportation
-30o C to 50o C (-22o F to 122o F) without batteries 12o C to 35o C (53.6o F to 95oF) with Single-Patient-Use leadsets Humidity Operating
< 95% RH at 37o C (98.6o F) non-condensing
> 15% RH low limit Storage and Transportation
< 90% RH at 50o C (122o F) without batteries
> 15% RH low limit Altitude Operating &
Non-operating
(includes Transportation) Barometric Pressure 3,000 m (9,842 ft) 72kPa (537 mmHg) Water Resistance MX40 Battery Compartment - IPX3 (protected against spraying water) MX40 Electronics Compartment - IPX7 (protected against immersion, up to 1m depth) MX40 Patient Cable when not attached to the MX40 (all connections) - IPX3 (protected against spraying water) MX40 to MX40 Patient Cable Connection (when patient cable is securely attached) - IPX7 (protected against immersion, up to 1m depth) Safety Standards & Specifications 10-27 Measurement Specifications Measurement Specifications ECG Parameter Specification ECG channel transmitted Leads 3 electrodes Channel #1 = I, II, or III 5 electrodes 5 electrodes, EASI 6 electrodes Channel #1 = II Channel #2 = III Channel #3 = MCL Channel #1 = Va-i Channel #2 = Va-s Channel #3 = Ve-s Channel #1= II Channel #2 = III Channel #3 = MCLa Channel #4 = MCLb Resolution 5 V ECG Input Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance
> 5 megohms (@ 10 Hz Input Dynamic Range
+/- 9 mV DC Offset Range
+/- 320 mV CMRR
> 90 dB @ 50, 60 Hz
(Active RL-drive is used for best CMRR performance.) Bandwidth +/- 3 dB 0.05 to 40 Hz Gain Accuracy
+/- 5% at 25 oC (77 oF) Noise Referred to ECG Input (Peak-to-Peak) AAMI: 30 V (as per AAMI EC 13) Lead Wires 3, 5 or 6-wire patient cable compatible with IntelliVue Patient Monitor, AAMI/IEC color codes Time to baseline recovery from Defibrillator AAMI: 5 s max (until ECG wave is on display but not yet centered, monitoring bandwidth) 10-28 Safety Standards & Specifications Measurement Specifications Parameter Specification Pacer Rejection Performance
(Pace pulses with no tails).
+2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms Positive pacers1 Amplitude Width
+2 to +500 mV 1.5 ms
+2 to +400 mV 2 ms Negative pacers1 Amplitude Width
-2 to -500 mV 1.5 ms
-2 to -400 mV 2 ms
-2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms 1 Philips does not claim, verify, or validate support for all available pacemakers. Heart Rate Numeric
(range, resolution and accuracy) Range: 15 bpm to 300 bpm (Adult, Pedi) Resolution: 1bpm, accuracy +/- 1% of the range Beat Detection Sensitivity: > 200 mV peak Heart Rate Meter Response Time to Change in Heart Rate Heart Rate Meter Response Time to Irregular Rhythm Meets AAMI EC-13 For a rate increase, the average time to reach the specified heart rate (40 bpm to 80 bpm) using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4.1.2.1(f) is 10 seconds. For a rate drop of 80 bpm to 40 bpm, the average time is 7 seconds. Provides correct heart rates (60, 80, 90, 120 bpm) using test waveforms as indicated in ANSI/AAMI EC13 Sec. 4.1.2.1(e). All QRS are counted with test waveforms within HR accuracy defined above. EMC Performance Limits, radiated immunity Meets Essential Performance. ECG Patient Cable Disconnection Safety All ECG connections are patient safe within 750 msec of patient cable removal, with patient leakage current <10 . Exception: Leadset detection pins are protected mechanically to prevent patient contact. ECG Performance Disclosure/Specifications For complete ECG Performance Disclosure information and specifications, see the IntelliVue MX40 Instructions for Use, Chapter 14. Safety Standards & Specifications 10-29 Measurement Specifications Distributed Alarm System Delay Specifications For complete Distributed Alarm System Delay information and specifications, see the Patient Information Center iX Instructions for Use. Respiration Parameter Specification Leads Used for Measurement RA, LL (standard) or I, A (EASI) Range Bandwidth Noise Adult/Pedi: 0 to 120 rpm 0.3Hz to 2.5Hz (-6dB) Less than 25 mOhm (rms) referred to the input Calibration Signal Signal: 1 Ohm p-p; Accuracy: 20%
Respiration Rate Resolution 1 rpm Respiration Accuracy 1 rpm for 0-120 rmp Auxiliary Current, Respiration Excitation Signal
< 470 uA rms @48KHz, sinusoidal waveform Respiration Alarm Alarm Range Delay Adult/Pediatric: 10 to 100 rpm 15 seconds High Low Adult/Pediatric: 0 to 95 rpm for limits from 0 to 20 rpm: max. 4 seconds for limits above 20 rpm: max. 15 seconds Apnea Alarm 10 to 40 seconds Incremental delay 5 seconds max. FAST SpO2 Parameter Specification SpO2 Measurement Range (Calibration and Display) 0 to 100%
SpO2 Accuracy See Performance Specification Details for Philips FAST Sensors MX40 C.01 Instructions for Use, Chapters 9 and 15.. 10-30 Safety Standards & Specifications Measurement Specifications Parameter Specification SpO2 Resolution 1%
SpO2 Numerics -
Averaging 5 - 20 seconds (default = 10 seconds) The effect of SpO2 pulse oximetry on data averaging is internally controllable by the patient worn monitorMX40, with no user controls. SpO2 & Pulse Numerics -
Update Rate Transmitted once per second. NoteThe update rate for the SpO2 pulse oximetry value and pulse rate is typically 1 second. This can be extended to a max. 60 s when NBP is measured on the same limb, with a corresponding INOP message after a max. of 30 s, indicating that the displayed values are not current values. Pleth Wave- Sampling Rate 125 sps Technical Alarms
(INOPs) Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is noisy, if light interference is detected, if the sensor is defective, if the measurement is erratic, or if the module is malfunctioning Wavelength Range 500 to 1000 nm NoteInformation about wavelength range can be especially useful to clinicians (e.g., clinicians performing photodynamic therapy). Pulse Rate Measurement Range: 30 to 300 bpm
(available only with Continuous SpO2) Accuracy: 2%
Resolution: 1 bpm Display of SpO2 numerics SpO2 values are displayed as xxx % SpO2 to meet ISO 9919. Emitted Light Energy
< 15 mW Safety Standards & Specifications 10-31 Measurement Specifications Masimo SET SpO2 Parameter Specification SpO2 Measurement Range (Calibration and Display) 0 to 100%
SpO2 Accuracy See Performance Specification Details for Masimo SET Sensors MX40 C.01 Instructions for Use, Chapters 9 and 15.. SpO2 Resolution 1%
SpO2 Numerics -
Averaging 5 - 20 seconds (default = 10 seconds) SpO2 & Pulse Numerics -
Update Rate Typical numeric update rate is once per second.. Pleth Wave- Sampling Rate 125 sps Technical Alarms
(INOPs) Triggered if the sensor is disconnected, if a pulse is not detected, if the signal is noisy, if light interference is detected, if the sensor is defective, if the measurement is erratic, or if the module is malfunctioning Wavelength Range 500 to 1000 nm NoteInformation about wavelength range can be especially useful to clinicians (e.g., clinicians performing photodynamic therapy). Pulse Rate Measurement Range: 25 to 240 bpm Accuracy with no motion: 3 bpm Accuracy with motion: 5 bpm Resolution: 1 bpm Display of SpO2 Numerics SpO2 values are displayed as xxx % SpO2 to meet ISO 80601-2-61 Emitted Light Energy
< 15 mW SpO2 Accuracy Specifications For complete SpO2 Accuracy Specification information, see the IntelliVue MX40 C.01 Instructions for Use, Chapters 9 and 15. 10-32 Safety Standards & Specifications Part Number 4535 649 35151 Printed in USA May 2022 Second Edition 4535 649 35151
1 | label | ID Label/Location Info | 168.40 KiB | May 26 2022 / June 17 2022 |
T Philips Medical Systems 3000 Minuteman Rd. Andover, MA 01810-1099 USA Made in USA from foreign Model #MX40-2C4 & domestic components. asad
(01)00884838XXXXXX (21)USOO7XXXXX YYYY-MM-DD. Service #: 4535 64X XXXXX ae GMDN: 33586 SIN] USXXXXXXXX Ee Rory -{y}-
REF] 865351 MAC | AAAAAAAAAAAA @) >< IPX7 FCC ID: PQC-MX40SH2C4 @:
IC: 3549B-MX40SH2C4 0123 c US
1 | agent letter | Cover Letter(s) | 608.25 KiB | May 26 2022 / June 17 2022 |
Philips Medical Systems DH : LI DS 12/1/2021 Philips Medical Systems 3000 Minuteman Road Andover, MA 01810, USA AUTHORITY TO ACT AS AGENT - FCC On our behalf, | appoint Larry Stillings, Compliance Worldwide, Inc., to act as our agent in the preparation of this application for equipment certification. | certify that submitted documents properly describe the device or system for which equipment certification is sought. | also certify that each unit manufactured, imported or marketed, as defined in FCC regulations will have affixed to it a label identical to that submitted for approval with this application. In signing this letter, Applicant certifies that neither the applicant nor any party to the application is not subject to a denial of Federal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "party" for these purposes. For instances where our authorized agent signs the application for certification on our behalf, |
acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko North America Inc., still resides still resides with us. Sincerely, |
Delroy Smith.
1 | confidential letter | Cover Letter(s) | 614.09 KiB | May 26 2022 / June 17 2022 |
Philips Medical Systems te i Li DS 12/1/2021 Philips Medical Systems 3000 Minuteman Road Andover, MA 01810, USA REQUEST FOR CONFIDENTIALITY - FCC FCC ID: PQC-MX40SH2C4 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules and FCC Guidance document 726920, we hereby request confidential treatment of information accompanying this application as outlined below:
PERMANENT LONG-TERM CONFIDENTIALITY:
Schematics Block Diagrams Theory of Operation Tuning Procedure Parts List SHORT TERM CONFIDENTIALITY FOR A PERIOD OF 180 DAYS:
Internal Photos When the device is marketed before the requested number of days listed above, the grantee will inform the TCB to release the Short-Term Confidentiality information withheld on the FCC equipment authorization website. The above information contains trade secrets and proprietary information not customarily released to the public. The public disclosure of this information might be harmful to the applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. Sincerely, DA xy, Fh Delroy Smith
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2022-06-17 | 2405 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2022-06-17
|
||||
1 | Applicant's complete, legal business name |
Philips Medical Systems North America Co.
|
||||
1 | FCC Registration Number (FRN) |
0017950635
|
||||
1 | Physical Address |
3000 Minuteman Road
|
||||
1 |
Andover, MA
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
V******@nemko.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
PQC
|
||||
1 | Equipment Product Code |
MX40SH2C4
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D****** S******
|
||||
1 | Title |
Principal Scientist / Project Leader
|
||||
1 | Telephone Number |
+ 1 9********
|
||||
1 | Fax Number |
1-978********
|
||||
1 |
d******@philips.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | 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 | 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?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 12/14/2022 | ||||
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 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | MX40 2.4 GHz wireless patient monitor | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | Yes | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | 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 | Grant Comments | Power listed is conducted. This equipment is authorized for use under portable RF exposure conditions. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | 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 | Firm Name |
Compliance Worldwide, Inc.
|
||||
1 | Name |
M******** M******
|
||||
1 | Telephone Number |
603-8********
|
||||
1 | Fax Number |
603 8********
|
||||
1 |
m******@complianceworldwide.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2405 | 2480 | 0.00046 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2401.06 | 2482.252 | 0.04853 |
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