IntelliVue MX40 Installation and Service Release C.
Notice Proprietary Information This document contains proprietary information, which is protected by copyright. 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.
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.
• 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.
Document Conventions In this guide: Warnings Warning 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. Cautions Caution A Caution alerts you to where special care is necessary for the safe and effective use of the product.
Contents 1. Introduction 1-1 Network Connectivity ------------------------------------------------------------------ 1-2 Network Components------------------------------------------------------------------ 1-3 2. Installation 2-1 MX40 Release C.
Main Screen Button ------------------------------------------------------------- 4-5 SmartKeys ------------------------------------------------------------------------- 4-6 Alarms Area ----------------------------------------------------------------------- 4-7 Patient Information Area ------------------------------------------------------- 4-8 Paced Status ---------------------------------------------------------------------- 4-8 Display Lock -----------------------------------------------------------------
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 Charg
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
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 .............................................................
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 865350 IntelliVue MX40 1.4 GHz Smart-hopping 865351 IntelliVue MX40 2.
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 .................................................
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.
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.
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.
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 equipment label. 8. Confirm the label assignment by viewing the waveform in the Patient Sector at the Information Center iX.
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.
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.
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.
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.
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 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.
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.
Frequency Management and Channel Selection Primary Low Center High Channel 3: 1398.2963MHz 1399.0963MHz 1399.8963MHz Channel 4: 1427.0979MHz 1427.8979MHz 1428.6979MHz Secondary Low Center High *Channel 5: 1428.6972MHz 1429.4972MHz 1430.2972MHz *Channel 6: 1430.2965MHz 1431.0965MHz 1431.8965MHz 1.4GHz Smart-hopping Channel Definition - Carved-out Areas* Primary Low Center High Channel 1: 1395.0977MHz 1395.8977MHz 1396.6977MHz Channel 2: 1396.6970MHz 1397.4970MHz 1398.
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.
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 25, 26, 15, 20 1, 4, 7, 11 25, 26, 11*, 20*, 21*, 24* 1, 4, 8, 11 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.
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.
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 Smarthopping Networks If a 2.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Frequency Management and Channel Selection SRR Channel Recommendations for 865352 Installations 802.11b/g (2.
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...................................................................
MX40 Test & Inspection Matrix MX40 Test & Inspection Matrix Test Block Name Test or "Inspection" to Perform What to Record on Service Record Visual Test: Inspect the MX40 (and packing material if applicable) for obvious signs of damage. Also check external leads and accessories. V:P or V:F where P=Pass F=Fail Expected Test Results: The device does not have any obvious signs of damage = Pass Power On: Remove patient cable. Insert battery into the MX40. The MX40 will go through its self-test and pass.
MX40 Test & Inspection Matrix Test Block Name Test or "Inspection" to Perform What to Record on Service Record 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.
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.
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 ..............................................................................................
Monitoring Mode Monitoring Mode Monitoring Mode is the normal operating mode of the MX40 and a password is not required. Warning If the MX40 displays a SW License Required message, remove the device from service. The device must be repaired/replaced. Caution 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.
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 reestablished. 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.
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 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
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).
Monitoring Mode SmartKeys The following table lists the SmartKeys available on the display of the MX40. Note—gray 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).
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. Alarms Area • The Alarm Area of the MX40 displays physiological alarms and technical alarms.
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.
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.
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.
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.
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.
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.
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.
Monitoring Mode Setting Description Paced Mode On, Off, Unconfirmed (IIC iX only) (Set at IIC Release N or IIC iX. View only.) Adjust Size Set ECG gain to x1/2, x1, x2, x4 Arrhythmia Initiate an Arrhythmia Relearn; View Arrhythmia Alarm Limits; Turn Arrhythmia Annotation On/Off (local control on device only.) Lead Placement Set EASI, Standard ECG Set ECG On/Off New Lead Setup When IntelliVue Patient Monitor lead sets are in use, select 3-wire, or 5-wire.
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 4-16 • The battery compartment door must be closed during defibrillation.
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.
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 .
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).
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.
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.
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.
Monitoring Mode 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.
Monitoring Mode Removing the Batteries 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.
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.
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.
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.
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.
Configuration Mode Setting Description MX40 with IIC N MX40 with IIC L/M MX40 with IIC iX Alarm Sounds: Sets MX40 alarm sound type to Traditional (Carenet) or ISO. Traditional, ISO Traditional, ISO Traditional, ISO Alarms On: Enable: All MX40/IIC Release N features available. Disable: MX40 operates as if connected to IIC Release L/M.
Configuration Mode The table below lists the settings that are configured using the individual parameter Setup menus for ECG, SpO2 and Resp: Setting Description Lead Placement: Sets the default lead 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.
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.
Service Mode • Options: List of enabled product options on the device. Enabled Product Option # Product Option S01 ECG only S02 ECG and SpO2 S03 ECG and SpO2 Ready (for future upgrade) S04 ECG and SpO2 (Masimo) C01 Enhanced Arrhythmia C03 24 hours of Vitals Trends J46 Short-Range Radio M02 Impedance Respiration Rechargeable Battery Information The Batt Info menu displays information about the rechargeable battery.
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.
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 .
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. Caution 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.
Cleaning 1. Remove the batteries and disconnect the patient cable. Note that disconnecting the patient cable for cleaning is dependent on your hospital’s 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.
Cleaning 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.
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 Resert XL HLD Isopropanol (70%) Hydrogen peroxide (1.4-2-3%) 2-Fumic Acid (<2.5%) Sporox II Sterilizing & Disinfection Solution Hydrogen peroxide (7.
Cleaning Cleaner Active Ingredient Bacillol AF 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) Dodecylamine (0.31 g) Didecyl dimethyl ammonium chloride (0.16 g) Benzalkonium chloride (0.03 g) Dismozon Plus Magnesium monoperoxyphthalate hexahydrate (≥90%, ≤100%); Tridecanol, branched, ethoxylated (≥1%, <2.5%); Amines, coco alkyldimethyl, N-oxides(≥1%, <2.
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.
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.
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). 2. Select Label Assignment. 3. Select the entry for both the previously assigned device (on the left) and the entry for the available device (on the right). 4. Select Replace. 5. At the MX40, select Confirm. 6. At the Information Center iX, select OK. 7.
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.
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.
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.
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 ..................................................................................
MX40 Support Parts MX40 Support Parts 1.
MX40 Support Parts 2.
MX40 Support Parts 802.
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.
Tools Required Tools Required Repair of the MX40 requires the following tools: 7-2 • MX40 Service Adapter Cable • PC running the IntelliVue Support Tool - Mark2 • Internet Connection to the Philips Software License Server 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.
Software License Transfer Required information from defective device: Notes on the MX40 Service Adapter and cable: • Original Ship To Address information (country, city) • The service adapter is for service and demo use only. • SW Serial Number, • It is not to be used in the patient vicinity. OR • 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.
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 ..........................................................................
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: 8-2 • Severe - Monitoring and alarm generation are disabled.
Technical Alarms (INOPs) Alarm Text Priority Condition What to do Cannot Analyze ECG Hard 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. Soft The QT Arrhythmia algorithm cannot reliably analyze the QT data on any monitored leads. • Change electrodes and/or electrode position. • Change Primary lead.
Technical Alarms (INOPs) • Alarm Text Priorit Condition What to do cl SpO2 Batt Empty Hard CL SpO2 Pod empty battery condition. Monitoring is not possible. • Replace CL SpO2 Pod. • Recharge depleted SpO2 Hard CL SpO2 Pod weak battery condition. Charge CL SpO2 Pod. Hard CL SpO2 Pod is not connected with the MX40. • Source - Cableless Measurement Device cl SpO2 Batt Low Pod. Source - Cableless Measurement Device cl SpO2 Disconnect • Reduce range between CL SpO2 Pod and MX40.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do Invalid Leadset Hard • FAST SpO2 leadset attached to MX40 with Masimo SET option. Replace with compatible leadset. • Masimo SET leadset attached to MX40 with FAST SpO2. (MX40 Revision dependent.) Source - MX40 Leadset Life Soft The single-patient use leadset has exceeded its limit of 25 cycles. Replace with new leadset. Red or Yellow or Hard Technical Alarm • Patient cable has been unplugged from the MX40.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do NBP Interrupted Hard The preset maximum time for the total measurement has been exceeded. Reduce patient movement and avoid interaction with the cuff and tubing. Hard Measurement values cannot be derived. • Attach cuff to new location on patient. • Replace cuff. No local alarming at the MX40, networked or nonnetworked. • IIC - Configuration specific setting. PIC iX - Contact Service.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do Resp Leads Off Hard Resp lead off. Re-attach lead to patient. Some ECG AlarmsOff Soft Some ECG alarms have been turned off at the Information Center. For information only. Speaker Malfunct Soft The MX40 Power-on Self Test detected a speaker failure. • Remove the MX40 from use. • Contact Service. Note — OR leadsets cannot be used to monitor Resp with the MX40.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do No Pulse Red or Yellow or Hard Technical Alarm Pulse is too weak or not detectable. Check connection to patient. Hard No sensor attached to SpO2 device. Attach SpO2 sensor. Hard Excessive patient movements or electrical interference are causing irregular pulse patterns Reduce movement or electrical noise sources. Soft Although a measurement may be possible, its accuracy may be reduced due to poor signal quality.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do Replc Cable Hard Yellow Hard condition - The connected SpO2 sensor cable is approaching expiration. (95%). Replace Masimo patient cable. Hard Yellow Technical Alarm Hard condition - the connected SpO2 sensor or adhesive life is approaching expiration. (95%). Replace sensor. (Masimo SET SpO2 only) Note — Depending on PIC iX revision, this may appear there as “Unknown” or “!!Cable life”.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do Sensor Off Hard 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. Note — The ability of the algorithm to detect this condition depends on the sensor type in use.
Technical Alarms (INOPs) • Alarm Text Priority Condition What to do Tele Battery Temp Hard The temperature of the lithium-ion battery is above 55o C or below -5o 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. Soft Lithium-ion battery has < 25 charge cycles remaining before reaching the charge cycle maximum limit.
Alarm Text Priority Condition What to do Tele Service Batt Hard The lithium-ion battery has exceeded the maximum charge cycle limit and reached the end of its useful life. • • • Note — When the above INOP occurs, the Tele Batt Low INOP is suppressed. • Replace the lithium-ion battery. Dispose of old battery properly. Source - MX40 Tele Weak Signal Soft • Source - MX40 • Transmitter Off Source - MX40 The MX40 is receiving a weak signal for > 6 seconds with high data loss from the AP.
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.
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 Short-range radio channel scan in progress. Cleared automatically when complete. SRR Channel Short-range radio channel scan is complete and best channel is selected. Cleared automatically after selection.
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 • The 865352 MX40 cannot use AA displays this icon. 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.
Additional Hardware Troubleshooting Information MX40 Reboots Intermittently Device reboots intermittently, possibly when • Check the battery. If there is damage bumped or tapped. This may be caused by and/or corrosion of the battery wear, corrosion, or damage to the: contacts, replace the battery.
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).
Additional Hardware Troubleshooting Information Problem Condition Visible corrosion of patient cable connector pins either on the MX40 or on the patient cable • • • • • 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 IN
Additional Hardware Troubleshooting Information Problem Condition Shorter run time than specified in • the IFU. • AA batteries 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.
Additional Hardware Troubleshooting Information Problem Condition Cyan LED at charging station slot • Rechargeable battery cannot establish communication with charger What to do. • • 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.
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.
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.
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).
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 assessment. 11. While the assessment is measuring the RSSI Value Field will display alternating dashes. 12. Once complete, the RSSI Value and Link Quality Indicator fields will populate. 13. To end the assessment at any time, press the blue Main Screen button.
Coverage Assessment Link Quality - WLAN Note—WLAN Link Quality & Rssi assessment with B.05 or greater with HW rev.C.01.01 or greater. Note—For deployment in the 5GHz band, only use the A-865350-90304-5GHz-WLAN CAV template. Note—The 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.
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.
Coverage Assessment Information from the data tab maps to the summary tab as shown below. 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.
Coverage Assessment Smart-hopping Link Information Definition/Setting Conn. Status Current wireless network connection status 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 RF Access Code The RF Access Code of the MX40, which must match the RF Access Code of the system it is intended to connect to.
Coverage Assessment 8-30 WLAN Link Information Definition/Setting 802.11n On, Off MAC Address The MAC address of the MX40 WLAN radio Network Info 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 Multicast address being used for the CI (Connect Indication) message. Regulatory Domain Country definition as determined by system configuration.
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.
WLAN Troubleshooting WLAN Troubleshooting Problem Possible Cause Solution MX40 fails to connect to Surveillance PIIC iX. 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: Verify the AP is powered on and connected to the customer-supplied infrastructure properly. MX40 display inop “No Central Monitor” and Connection Status is in state “None”.
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.
WLAN 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.
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-finderresults?sort_by=certified&sort_order=desc&keywords=MX40&companies=21 Short-range Radio and WLAN ....
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 Smarthopping and SRR Channel Selection for 2.4GHz Smart-hopping Networks p. 2-17.
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.
WLAN Configuration Parameters Hardware Wireless WLAN Applicable to MX40 Available Selections Comments WMM Mode Yes Disabled, Enabled To enable QoS, this must be set to "Enabled", and QoS State on the Network menu page must be set to "On". Security Mode Yes WEP, WPA (PSK), WPA2 (PSK), WPAEnterpr, WPA2Enterpr WPA2-Enterprise is not recommended due to increased handover times. Mode Yes Auto, 802.11ah, 802.11bg, 802.11g 802.11 ah is recommended.
WLAN Configuration Parameters Parameter Applicable to MX40 Available Selections Comments Inner Authentication Yes NotConfigrd, PAP, CHAP, MSCHAP, MSCHAPv2 The MX40 only supports MSCHAPv2. PEAP Version Yes Default, Version 0, Version 1 PEAP Label Yes Default, EAP, PEAP Certificate Check Yes Disabled, Enabled Should be "Enabled" is using a certificate. "Disabled" is provided for troubleshooting purposes.
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.
WLAN Configuration Parameters • SSID Service Set Identifier: Logical WLAN Network Name. WEP • WEP Key Index 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 The WEP Key Size 40 bit or 104 bit • WEP Key The number of hex characters for the WEP key depends on the WEP key size chosen.
WLAN Configuration Parameters The PEAP label setting defines the string to be used to signal EAPPEAP 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.
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 MX40’s 802.11 Listen Interval is hardcoded to three beacon intervals or roughly 300ms (based on a typical access point beacon period of 100 TUs).
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............................................................................
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 product’s development. AC Power Source The system is not intended for connection to the public mains as defined in CISPR-11.
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 Me
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 manage
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.
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.
Regulatory Information Dropouts 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.
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.
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 606011-2, 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.
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.
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.
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) ±6 kV contact ±6 kV contact IEC 61000-4-2 ±8 kV air ±8 kV air 4th Edition: Floors should be wood, concrete, or ceramic tile.
Electromagnetic Compatibility Interference may occur in the vicinity of equipment marked with this symbol: Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF 3 Vrms 3 VRMS IEC 61000-4-6 150 kHz to 80 MHz Recommended separation distance: d = 1.2√P 6 Vrms in ISM bands Radiated RF IEC 610004-3 3 V/m 80 MHz to 2.7 GHz 3 V/m See Note under “Electromagnetic Compatibility” on page 1010. Recommended separation distance: 80 MHz to 800 MHz d = 1.
Electromagnetic Compatibility Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Equation d = 1.2√P d = 1.2√P d = 2.3√P Rated max. output power of transmitter Separation distance Separation distance Separation distance 0.01 W 0.1 m 0.1 m 0.2 m 0.1 W 0.4 m 0.4 m 0.7 m 1W 1.2 m 1.3 m 2.3 m 10 W 3.8 m 3.8 m 7.3 m 100 W 12.0 m 12.0 m 23.
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) ECG Only Battery Life (1.4GHz p/n 865350) 37.
Battery Specifications Monitor Mode Networked (Display On) Battery Life (1.4GHz p/n 865350) Battery Life (2.4GHz p/n 865351) ECG Only 10.5 hours 9.5 hours ECG/SpO2 FAST Continuous 5.3 hours 2.5 hours ECG/SpO2 Masimo Continuous 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) Battery Life (1.
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.
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 Nominal Current (p/n 865350) Nominal Current (p/n 865351) Nominal Current (p/n 865352) ECG Only FAST (Display inactive) 51.5 mA @ 3.6V 51.0 mA @ 3.
Physical Specifications Physical Specifications Parameter Specification Height 126.8 mm (4.99 in) Width 69.9 mm (2.75 in) Depth 31.5 mm (1.24 in) Weight 1.4 GHz - 223 g (7.8 oz) • Without batteries, includes SpO2 2.4 GHz - 223 g (7.8 oz) WLAN - 206 g (7.3 oz) • With 3 AA batteries, includes SpO2 and all hardware options 1.4 GHz - 298 g (10.5 oz) • With lithium-ion battery, includes SpO2 and all hardware options 1.4 GHz - 289 g (10.2 oz) 2.4 GHz - 298 g (10.5 oz) 2.4 GHz - 289 g (10.2 oz) 2.
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.
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 Channel Spacing: 1.728 MHz RF Output Power 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.
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 Configured via the bedside monitor or the Information Center depending on use model. RF Output Power -1.5 to -4.5 dBm +2/-3dB (0.7 mW to 0.3 mW), into Antenna load.
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 IEEE 802.11 b Frequency Range 2.4 to 2.
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.
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 LELAN devices.
MX40 2.4 GHz WLAN Radio Attention Les radars de grande puissance sont attribués en priorité aux bandes 5 250-5 350 MHz et 5 650-5 850 MHz. Ces radars peuvent occasionner des interférences et/ou des dommages aux dispositifs LE-LAN.
Environmental Specifications Environmental Specifications Parameter Specification Temperature Operating 0 to 37o C (32 to 99o F) Storage and -30o C to 50o C (-22o F to 122o F) without batteries Transportation 12o C to 35o C (53.6o F to 95oF) with Single-Patient-Use leadsets Humidity Operating < 95% RH at 37o C (98.
Measurement Specifications Measurement Specifications ECG Parameter Specification ECG channel transmitted Leads 3 electrodes Channel #1 = I, II, or III 5 electrodes Channel #1 = II Channel #2 = III Channel #3 = MCL 5 electrodes, EASI Channel #1 = Va-i Channel #2 = Va-s Channel #3 = Ve-s 6 electrodes Channel #1= II Channel #2 = III Channel #3 = MCLa Channel #4 = MCLb Resolution 5 µV ECG Input Differential, defibrillator protected against 360 joules discharge into a 100 ohm load Input Impedance
Measurement Specifications Parameter Specification Pacer Rejection Performance Positive pacers1 (Pace pulses with no tails). Amplitude Width +2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms +2 to +500 mV 1.5 ms +2 to +400 mV 2 ms Negative pacers1 Amplitude Width -2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms -2 to -500 mV 1.5 ms -2 to -400 mV 2 ms 1 Philips does not claim, verify, or validate support for all available pacemakers.
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 Adult/Pedi: 0 to 120 rpm Bandwidth 0.3Hz to 2.
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 - Transmitted once per second. Update Rate Note—The update rate for the SpO2 pulse oximetry value and pulse rate is typically 1 second. This can be extended to a max.
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 - Typical numeric update rate is once per second..
Part Number 4535 649 35151 Printed in USA May 2022 Second Edition 4535 649 35151
