Philips Intellivue MP5 User manual

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Service Guide

IntelliVue Patient Monitor

MP5/MP5T/MP5SC

Rel. L.x

Patient Monitoring

1Table of Contents

1 Introduction 7

Who Should Use This Guide 7 How to Use This Guide 7 Abbreviations 7 Responsibility of the Manufacturer 7 Passwords 8 Warnings and Cautions 8

2 Theory of Operation 9

Monitor Theory of Operation 9

3 Testing and Maintenance 25

Introduction 25 Terminology and Definitions 25 Recommended Frequency 26 When to Perform Tests 27 Testing Sequence 30 Visual Inspection 30 Safety Tests 31 System Test 55 Preventive Maintenance Procedures 66 Performance Assurance Tests 66 Reporting of Test Results 92 Other Regular Tests 95 Touchscreen Calibration 95 Disabling/Enabling Touch Operation 96 Printer Test Report 96 Battery Handling, Maintenance and Good Practices 97 After Installation, Testing or Repair 105

4 Troubleshooting 107

Introduction 107 How To Use This Section 107 Who Should Perform Repairs 107 Replacement Level Supported 107 Software Revision Check 108 Software Compatibility Matrix 108 Obtaining Replacement Parts 108 Troubleshooting Guide 108

5 Repair and Disassembly 135

Who Should Perform Repairs 135 Tools required 136 Removing the Handle or Bedhanger 136 Removing the Predictive Temperature Assembly 137 Disassembling the Predictive Temperature Assembly 139 Removing/Exchanging the NBP Inlet 140 Separating the Front and Back of the Monitor 142 Removing the Recorder Slot Cover 146 Removing the Internal Quick Mount Solution 147 Removing the Short Range Radio (SRR) Interface 147 Removing the IntelliVue 802.11 Bedside Adapter Antenna or IIT Antenna (not for MP5T) 149 Removing the IntelliVue 802.11 Bedside Adapter (WLAN) (not for MP5T) 149 Removing the IntelliVue Instrument Telemetry (IIT) Module (not for MP5T and MP5SC) 153 Removing the IntelliVue 802.11 Bedside Adapter/IIT Holder 154 Removing the MSL Board (not for MP5T and MP5SC) 155 Removing the Backlight Inverter Board (Old NEC Display) 156 Removing the Backlight Converter Board (New NLT Display) 158 Removing the Power Supply 159 Removing the System Interface Board 160 Removing the Recorder Board 161 Removing the Microstream CO2 Assembly 163 Removing the Measurement Block 169 Removing the NBP Pump 173 Removing the Main Board 175 Removing the Touch Assembly 178 Removing the Loudspeaker 180 Removing the Power Button and LED Assembly 180 Removing the LCD Panel 181 Exchanging the Backlight (Old NEC Display only) 182 Modifying the Nurse Call Relay 183

6 Parts 187

MP5/MP5T/MP5SC Parts 187 External Display Part Numbers (not for MP5T) 201 Tympanic Thermometer Part Numbers 203 Smart Battery Charger Part Numbers 203 Test and Service Tools 204

7 Installation Instructions 207

Out-Of-Hospital Transport - Standards Compliance 207 Electromagnetic Emissions 209 Electromagnetic Interference (SRR) 209 Installation Checklist 209 Unpacking and Checking the Shipment 210 Installing the Predictive Temperature Probe 211

Installing the Tympanic Thermometer 213 Installing the HS1-R Barcode Reader 216 Mounting the Monitor 226 Connecting the Monitor to AC Mains 233 Checking Out The Monitor 233 Loading Paper 236 Configuration Tasks 236 Network Configuration Tasks (Rev H.0 or higher) 239 Handing Over the Monitor 248 Installing Remote Devices (not for MP5T) 249 Clinical Network (Wired and Wireless) 251 Philips IntelliVue Information Center 251 IntelliVue Instrument Telemetry (IIT)(not for MP5T and MP5SC) 251 Short Range Radio 252 Connecting the MP5 to a Host Monitor (not for MP5T and MP5SC) 255 Nurse Call Relay (not for MP5T) 255 ECG Out Functionality (ECG Sync) (not for MP5T and MP5SC) 256 ECG Sync Pulse (not for MP5T and MP5SC) 256

8 Site Preparation 259

Introduction 259 Monitor Site Requirements 261 Remote Device Site Requirements 262 Remote Displays (M8031B) 264 Remote Displays - M8033C 264 Cabling Options and Conduit Size Requirements 265 Touch Cable 266 MSL Cables 266 Philips Medical LAN 267 LAN Interface 267 Telemetry Device (Patient Worn Device) cables 268 Nurse Call Relay Interface 268 ECG Out Interface 269

9 Gas Analyzers (not for MP5T and MP5SC) 271

10 Specifications 273

Essential Performance Characteristics 273 MDD Classification 275 Classification According to IEC 60601-1 275 Safety and Regulatory Information 275 Use Environment 275 Disconnecting from Power 276 Symbols 276 Physical Specifications 278 Environmental Specifications 278

1Introduction

This Service Guide contains technical details for the IntelliVue MP5/MP5T/MP5SC Patient Monitor

This guide provides a technical foundation to support effective troubleshooting and repair. It is not a comprehensive, in-depth explanation of the product architecture or technical implementation. It offers enough information on the functions and operations of the monitoring system so that engineers who repair them are better able to understand how it works.

Who Should Use This Guide

This guide is for biomedical engineers or technicians responsible for installing, troubleshooting, repairing, and maintaining Philips’ patient monitoring systems.

How to Use This Guide

Navigate through the table of contents at the left of the screen to select the desired topic. Links to other relevant sections are also provided within the individual topics. You can also scroll through the topics using the page up and page down keys.

Abbreviations

Abbreviations used throughout this guide are:

Name Abbreviation

IntelliVue MP5/MP5T/MP5SC Patient Monitor the monitor

Medical Information Bus MIB

Responsibility of the Manufacturer

Philips only considers itself responsible for any effects on safety, EMC, reliability and performance of the equipment if:

• assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Philips, and

• the electrical installation of the relevant room complies with national standards, and

1Introduction

• the instrument is used in accordance with the instructions for use.

To ensure safety and EMC, use only those Philips parts and accessories specified for use with the monitor. If non-Philips parts are used, Philips is not liable for any damage that these parts may cause to the equipment.

This document contains proprietary information which is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws.

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard Str. 2

71034 Böblingen, Germany

The information contained in this document is subject to change without notice.

Philips 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 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.

Passwords

In order to access different modes within the monitor a password may be required. The passwords are listed below.

CAUTION

Your hospital/organization is responsible that the passwords listed below are revealed to authorized personnel only.

Monitoring Mode: No password required

Configuration Mode: 71034

Demo Mode: 14432

Service Mode: 1345

Consult the configuration guide before making any changes to the monitor configuration.

Warnings and Cautions

In this guide:

•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

•A caution alerts you 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.

2Theory of Operation

Monitor Theory of Operation

The IntelliVue MP5/MP5T/MP5SC patient monitor is used for monitoring and recording multiple physiological parameters of adults, pediatrics, and neonates. The monitor also generates alarms for the measured parameters. The monitor is used by trained healthcare professionals in a hospital environment.

The monitor stores data in trend, event, and calculation databases. You can see tabular trends (vital signs) and document them on a printer. You can view measurement trend graphs, with up to three measurements combined in each graph, to help you identify changes in the patient's physiological condition. You can view fast-changing measurement trends with beat to beat resolution and see up to four high resolution trend segments. Event surveillance enhances documentation and review of physiologically significant events by automatically detecting and storing up to 50 user-defined clinical events over a 24 hour period.

The monitor can be configured with various different measurement and interface capabilities.

The following comparison table shows in detail the differences between MP5, MP5T and MP5SC:

Functionality (including optional features) MP5 MP5T MP5SC

ECG yes no no

SpO2 yes yes yes

NBP yes yes yes

Predictive Temperature yes yes yes

Temperature yes no no

Invasive Pressure yes no no

Carbon Dioxide yes no no

Microstream CO

Direct Telemetry Connection yes yes no

ECG Output signal yes no no

LAN networking capability yes no yes*

WLAN networking capability yes no yes*

IntelliVue Instrument Telemetry networking capability yes no no

USB Interface yes no yes

Short Range Radio capability yes yes yes

yes no yes

2 Theory of Operation

Functionality (including optional features) MP5 MP5T MP5SC

Severe Sepsis Screening yes no no

OxyCRG high resolution trend yes no no

Neonatal event review yes no no

Integrated recorder yes yes yes

Drug Calculator yes yes no

Gas monitor support yes no no

Connection to a host monitor (companion mode) yes no no

Connection to an external display yes no yes

Nurse call capability yes no yes

Spot Check yes no yes

Multi-Patient Spot Check no no yes

Early Warning Score yes no yes

* For MP5SC LAN and WLAN Networking capability are only available for HL7 export, not for IIC support.

NOTE

The following descriptions may vary depending on the monitor option purchased.

System Boundaries

The following diagram discusses specific boundaries within the overall system with respect to their openness and real-time requirements:

System Boundaries

2 Theory of Operation

Measurement connections

Built-in measurement block

Philips Clinical Network (wired LAN)

connects multiple patient monitors, information centers, application servers; closed system, only Philips qualified products (tested and with regulatory approval) are connected, Philips is responsible for guaranteed real-time functionality and performance

Philips Clinical Network (wireless)

like Philips Clinical Network (wired) LAN, however due to current wireless technologies available it has reduced bandwidth, longer latencies, reduced functionality

Hospital LAN, Internet

Standard Network, not under Philips control, no guaranteed service, no real-time requirements

2 Theory of Operation

Hardware Building Blocks

The following hardware building blocks make up the monitoring system. (Note that the MP5T and MP5SC do not include all the hardware components shown below):

MP5/MP5T/MP5SC Hardware Building Blocks

IntelliVue MP5/MP5T/MP5SC

The MP5/MP5T/MP5SC monitor:

• integrates the display and processing unit into a single package

• uses a 8.4” TFT SVGA color display

• uses the Touchscreen as input device

• integrates the measurement block (Front End 1 (FE1) and Front End 2 (FE2)) with optional parameter sets

Optional Hardware

• One slot is provided for one of three available system interface boards. An optional built-in wireless network interface IntelliVue 802.11 Bedside Adapter or IntelliVue Instrument Telemetry) is supported. For further details regarding the wireless network please refer to the M3185A Philips Clinical Network documentation.

• optional recorder

• optional battery

• optional MSL board

• optional Short Range Radio (SRR) board

2 Theory of Operation

Power Distribution

Power Distribution Architecture

The AC/DC converter transforms the AC power (100-240 V AC range) coming from the power plug into a 24 V / 50W DC source and isolates the monitoring system from the AC power mains.

The 24 V DC is distributed via the Interface Board to the optional battery charging circuit and to the main- and recorder board.

2 Theory of Operation

If the interface board contains the optional battery circuits, the power is used to charge the battery and supply the monitoring system. As soon as the AC power source is disconnected, the optional battery starts and keeps the system powered (battery mode). A DC/DC converter on the interface board converts the 8-12.6 V DC power supplied by the battery into 15 V DC power, which is distributed to the monitoring system.

The main board and recorder board contain power supply circuits, which convert the 24 /15 V DC into several voltages supplying the particular components of the monitoring system.

The realtime clock and the buffered RAM is supplied with cont. 3.6 V DC power, provided either by the 24 / 15 V DC system power or by the battery power and converted to 3.6 V DC.

The CPU board has an MPC852/62 MHz processor in the patient monitor that provides a number of on-chip, configurable interfaces. An array of fast UARTS with configurable protocol options are implemented in an ASIC (along with other system functions such as independent watchdogs, video, etc.), providing interfacing capabilities to integrated measurements and System Interface Boards. The serial interfaces can easily be electrically isolated. The main board contains additional video hardware.

The CPUs provide a LAN interface to connect to the Philips Clinical Network (Ethernet).

NOTE

An MP5 in companion mode does not receive its power from the host monitor via the MSL. MP5 is always powered by AC power or battery.

System Interfaces

The following is a list of Interface boards which may be present in your monitor, depending on your purchased configuration:

System Interface boards:

• Basic: LAN, Video #J01(no longer orderable)

• Battery: LAN, Battery Board, mCO

• Full: LAN, Battery, MIB/RS232, Video, Nurse Call, mCO

• Full USB: LAN, Battery, USB, Video, Nurse Call, mCO

Note that WLAN, IIT and MSL Interface require the full system interface board or the Full USB system interface board.

The MP5T is delivered only with the Battery system interface board. The MP5SC is delivered only with a Full USB system interface board.

The specifications for the above listed interfaces can be found in the technical data sheet for the monitor and in the Installation and Specifications chapter of the Instructions for Use.

#J02

#J43

#J40

Compatible Devices (not for MP5T and MP5SC)

IntelliVue G1/G5 Anesthetic Gas Module

Data Flow

The following diagram shows how data is passed through the monitoring system. The individual stages of data flow are explained below.

2 Theory of Operation

Data Acquisition

Monitoring data (for example patient measurement data in the form of waves, numerics and alerts) is acquired from a variety of sources:

• Measurement Block The integrated measurements convert patient signals to digital data and apply measurement

algorithms to analyze the signals.

• External measurement devices Data can be also acquired from devices connected to interface boards of the monitor. Software

modules dedicated to such specific devices convert the data received from an external device to the format used internally. This applies to the IntelliVue G1/G5 Anesthetic Gas Module (not for MP5T and MP5SC).

Data Flow

2 Theory of Operation

• Server systems on the Philips Clinical Network To enable networked applications such as the other bed overview, data can be acquired from server

systems attached to the Philips Clinical Network, for example a Philips Information Center

Data Provider System Service

All data that is acquired from integrated measurements or external measurement devices is temporarily stored by a dedicated data provider system service. All monitor applications use this central service to access the data in a consistent and synchronized way rather than talking to the interfaces directly.

This service makes the applications independent of the actual type of data acquisition device.

The amount of data stored in the data provider system service varies for the different data types. For example several seconds of wave forms and the full set of current numerical values are temporarily stored in RAM.

Persistent Data Storage System Service

Some applications require storage of data over longer periods of time. They can use the persistent data storage system service. Dependent on the application requirements, this service can store data either in battery backed-up (buffered) memory or in flash memory. The buffered memory will lose its contents if the monitor is without power (not connected to mains) for an extended period of time. The flash memory does not lose its contents.

The trend application for example stores vital signs data in a combination of flash memory and buffered memory, while the system configuration information (profiles) is kept purely in flash memory.

Display and User Interface Service

Applications can use high level commands to display monitoring data or status and command windows on the internal LCD panel. These commands are interpreted by the display manager application. This application controls the dedicated video hardware which includes video memory and a special hardware in the ASIC.

User input is acquired from the touchscreen. The system software makes sure that the user input is directed to the application which has the operating focus.

Monitor Applications

The monitor applications provide additional system functionality over the basic measurement and monitoring capabilities. This includes for example trending, report generating, event storage or derived measurements.

In general, the monitor applications use the data provider system service to access the measurement data. Application interfaces to the other system services allow the application to visualize data, to store data over extended periods of time or to output data to other devices.

Internal LAN (Measurement Link)

The MP5 communicates as a Multi-Measurement Module (MMS) in companion mode when connected to a host monitor using an IEEE802.3/Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the the MP5 and the host monitor, for example:

• Digitized patient signals including wave data, numerical data and status information (typically from the measurement server to a display unit)

2 Theory of Operation

• Control data representing user interactions (typically from the display unit to a measurement server)

• Shared data structures, for example representing patient demographical data and global configuration items

The internal LAN allows plug and play configuration of the monitoring system. The system automatically detects plugging or unplugging of measurement servers on the host monitor and configures the system accordingly.

The components on the internal LAN are time-synchronized to keep signal data consistent in the system. Dedicated hardware support for synchronization eliminates any latency of the network driver software.

The integrated LAN provides deterministic bandwidth allocation/reservation mechanisms so that the real-time characteristic of signal data and control data exchange is guaranteed. This applies to the data flow from the measurement server to the monitor (for example measurement signal data) and the data flow from the monitor to a measurement server (for example to feed data to a recorder module).

Integrated communication hubs in the monitor allow flexible cabling options (star topology, daisy chaining of servers).

NOTE

The MP5 does not support any MMS on the MSL.

Microstream CO2

CO2 sample rate: 20 samples/second

Calculation of end tidal CO

The M3015A/B MMS Extensions use Microstream® non–dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 during every breath, the amount of CO2 present at the

end of exhalation (etCO rate. The displayed etCO the Max Hold setting (configuration mode). It can be set to no peak picking (off), 10 seconds and 20

seconds.

Test method for respiration rate range:

A breath simulator system combined with CO covering the specified range. The resulting end tidal CO Differences between actual and expected end tidal CO accuracy for the respective respiration rate, i.e. there was no effect of the respiration rate on the end

tidal CO

values beyond those limits.

Philips Clinical Network

The monitoring system may be connected to the Philips Clinical Network, for example to provide central monitoring capabilities or other network services. This connection may be through a normal wired connection or through a wireless connection.

(etCO2):

), the amount of CO2 present during inhalation (imCO2), and the respiratory

is the maximum etCO2 over the previous peak-picking interval as defined by

and N2 gases was used to simulate respiration rates

values were compared to the expected value.

values were within the limits of the specified

The monitor supports the connection of an internal wireless adapter, depending on the monitor model (#J35, #J45, #J47). Switching between wired and wireless networks is automatically triggered by the plugging or unplugging of the network cable.

2 Theory of Operation

After configuration, the monitoring system sends the digitized patient signals including wave data, numerical data and status information onto the network. Control data representing user interactions can be exchanged between the monitoring system and a central station bi-directionally.

Additional protocols are supported for networked applications, for example for the other bed overview function, which allows viewing of monitoring data from other patients on the network.

For plug and play operation, the monitoring system uses the standard BootP protocol to automatically acquire a network address.

How does the Support Tool Work with the Monitor

The support tool is a Windows application typically installed on the laptop of a customer engineer or a biomedical engineer working in the customer’s own service department.

The purpose of the support tool is to upgrade, configure and diagnose all monitoring components in the system over the network.

The service protocol developed for this purpose uses a raw access to the devices without the need for IP addresses etc. over a standard customer network installation, so that even defective devices can be upgraded as long as the few kBytes of initial boot code are working. The boot code itself can also be upgraded using the same protocol.

The tool allows access to internal service information and to serial numbers. It can be remotecontrolled, for example via a dial-up connection from a response center, provided the proper infrastructure is in place.

For details see the Instructions for Use for the Support Tool.

Monitor Software Block Diagram

The following shows the functional block diagram for the monitoring system. A legend explaining terms and diagram elements follows. The information below varies depending on the purchased monitor options.

2 Theory of Operation

IntelliVue Patient Monitoring System Functional Block Diagram

2 Theory of Operation

Block Diagram Legend

Functional Block Description

Services

Operating System The Operating System (OS) provides a layer of isolation

System Services The System Services provide generic common system

Applications

Reports The Reports Service retrieves current and stored physiological

between the specific hardware implementation and the application software. The OS performs system checks and allocates resources to ensure safe operation when the system is first started. This includes internal self-tests on several hardware modules and configuration checks for validity of configuration with the operating software. During normal operation, the OS continues to run checks on system integrity. If error conditions are detected the OS will halt monitoring operations and inform the operator about the error condition.

services. In particular: They use a real-time clock component to track time. They synchronize to network time sources and verify the accuracy of the system time information. They are also responsible for managing persistent user configuration data for all Measurement parameters and IntelliVue Patient Monitoring System software modules. User configuration data is stored in a non-volatile read/write storage device

data and status data to format reports for printing paper documentation. Examples of supported reports:

• Vital Signs Report

• Graphical Trend Report

• Event Review Report

• Event Episode Report

• ECG Report (12 Lead/Multi-Lead)

• Test Report

The Reports service generates report data which can be printed on a central printer.

Record The Record Service retrieves current and stored physiological

data and status data to format a continuous strip recording. A recording can be triggered manually by the operator or automatically by an alarm condition. The Record Service uses the services of the Recorder Interface to control a recorder. The Record Service can also send data to a central recorder.

2 Theory of Operation

Functional Block Description

Alarm The Alarm Service contains logic that prioritizes alarm

conditions that are generated by IntelliVue Patient Monitoring System software modules. Visual alarm signals (messages) are displayed at the top of the IntelliVue Patient Monitoring System display and alarm sounds are generated by a loudspeaker. Alarm conditions may be generated when a physiological parameter exceeds preselected alarm limits or when a physiological parameter or any other software module reports an inoperative status (technical alarm, for example, the ECG leads may have fallen off the patient). The Alarm service manages the alarm inactivation states, for example suspension of alarms, silencing of alarms, and alarm reminder. Alarm signals may also be configured as latching (alarm signals are issued until they are acknowledged by the operator, even when the alarm condition is no longer true). The Alarm service controls the visual alarm signals (alarm lamps).

Trend The Trend service stores the sample values of physiological

data and status data with a resolution of 12 seconds, 1 minute or 5 minutes for a period of up to 48 hours. The data is kept in battery buffered read/write storage and flash memory devices to be preserved across power failures. The stored data is protected via consistency checks and checksums. When a new patient is admitted, the trend database erases all data of the previous patient.

OxyCRG The OxyCRG (Oxygen CardioRespiroGram) service derives a

high-resolution trend graph from the Beat-to-Beat Heart Rate, SpO2, and Respiration physiological data. The OxyCRG is specialized for neonatal applications, allowing the operator to identify sudden drops in Heart Rate (Bradycardia) and SpO2 (Desaturation), and supporting the operator in visualizing Apnea situations.

ADT The ADT (Admit/Discharge/Transmit) service maintains the

patient demographics information. The operator may admit a new patient, discharge the old patient and enter or modify the patient demographics.

Calc Param The Calc Param (Calculated Parameters) application performs

calculations on physiological numerical values to derive calculated parameters like Temperature Difference.

Interface Managers

2 Theory of Operation

Functional Block Description

MDSE The MDSE (Medical Data Service Element) Interface

Printer The Printer Interface Manager provides a high level interface

Display & Operator Interface The Display and Operator Interface Manager performs the

Manager is responsible for the exchange of real-time data between the IntelliVue Patient Monitoring System display unit and the Measurement parameters and other devices attached to the network. MDSE establishes and maintains a data communication link between the devices. It provides configuration information about the remote device to applications in the local device and it allows the exchange of measurement data and status information between the devices.

to a printer. It provides means to:

• establish a connection to the printer

• transfer data to the printer

• get status of the printer

• close connection to the printer

The Printer Interface Manager also supervises the connection to the printer and whether the printer accepts data (for example paper out). The Printer Interface Manager notifies the operator in such cases.

following tasks:

Interfaces

• Screen presentation of real-time and stored physiological measurement data, alarm condition data and status information received from the MDSE interface manager, the Alarm service or other IntelliVue Patient Monitoring System modules

• Screen presentation of operating controls (control windows)

• Processing of operating control commands received from HIF Control interface. The module verifies and interprets the received commands and forwards them to other software modules of the IntelliVue Patient Monitoring System display unit or measurement parameters.

• Sound generation (issues audible alarm signals and generates audible information signals, for example QRS and SpO2 tones, operator audible feedback)

2 Theory of Operation

Functional Block Description

LAN The LAN interface implements the physical layer of IEEE

802.3. The LAN interface performs Manchester encoding/

decoding, receive clock recovery, transmit pulse shaping, jabber, link integrity testing, reverse polarity detection/ correction, electrical isolation, and ESD protection. Electronically separated interfaces are used for communication to the Measurement parameters and to the network.

Display Controller The Display Controller Interface consists of a video

controller, video RAM and the controlling software. The Display Controller interface processes the high level display commands (character and graphic generation, wave drawing) and translates them into pixels, which are written into the video RAM where the video controller chip generates the video synchronization signals and the pixel stream for the Color LCD Display.

HIF Control The HIF (Human Interface Control) interface scans the

Human Interface devices for operator controls (Touch Screen), formats the collected data and sends it to the display and Operating Interface.

ECG-Out Marker-In (not for MP5T and MP5SC)

The ECG Out/Marker In interface receives the ECG waveform directly from the ECG/Resp Arrhythmia STSegment physiological algorithm running on the main CPU and converts the digital ECG signal to an analog ECG signal. In addition, the ECG Out hardware receives from a connected device the marker information and forwards this data to the ECG/Resp Arrhythmia ST-Segment physiological algorithm. The converted analog signal is used to synchronize a connected device to the patient’s ECG

Nurse Call (not for MP5T)

MIB (not for MP5T and MP5SC)

The Nurse Call board contains a phone jack type connector with a single close-on-alarm relay.

The MIB interface allows full-duplex, short-haul asynchronous binary communication between the monitor and an arbitrary (medical/non-medical) device using an eightpin RJ45 modular connector. Communication protocols using this interface can be configured.

ECG Sync Out (not for MP5T and MP5SC)

IIT (not for MP5T and MP5SC)

A pulse signal is provided on the RS-232 interface to allow synchronisation with other medical devices.

The built-in IIT adapter allows operation of the MP5 monitors within IntelliVue Instrument Telemetry infrastructure.

WLAN (not for MP5T)

The bulit-in WLAN interface allows wireless operation of the MP5 monitors with the IntelliVue 802.11 Bedside Adapter.

SRR The built-in SRR interface allows wireless communication of

the MP5, MP5T and MP5SC monitors with an IntelliVue Instrument Telemetry Transceiver.

2 Theory of Operation

Functional Block Description

MSL (not for MP5T and MP5SC)

USB Interface (not for MP5T)

All components of the monitoring system communicate using an IEEE802.3/ Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the components

The USB interface allows connection of USB devices (Mouse, Keyboard, Barcode Scanner) to the monitor. Note that USB printers are not supported.

3Testing and Maintenance

Introduction

This chapter provides a checklist of the testing and maintenance procedures to ensure the performance and safety of the monitor.

These tests must be performed only by qualified personnel certified by the responsible organization. Qualifications required are: training on the subject, knowledge, experience and acquaintance with the relevant technologies, standards and local regulations. The personnel assessing safety must be able to recognize possible consequences and risks arising from non-conforming equipment.

All recurring safety and performance assurance tests must be performed under equal environmental conditions to be comparable.

Preventive Maintenance refers specifically to the series of tests required to make sure the measurement results are accurate. The accuracy and performance procedures are designed to be completed as specified in the following sections or when readings are in question.

For detailed instructions on the maintenance and cleaning of the monitor and its accessories, see Care and Cleaning, Using Batteries and Maintenance and Troubleshooting in the monitor's Instructions for Use.

Terminology and Definitions

The following terms and definitions are used throughout this chapter and taken from the international standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.

• Medical System: a medical electrical system is a combination of at least one medical electrical device and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

• Patient Environment: any area in which intentional or unintentional contact can occur between the patient and parts of the medical system or between the patient and other persons who have had contact with parts of the medical system. The patient environment is defined anywhere within

1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.

• Separation Device/Transformer: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a medical system.

• Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to be connected to or integrated with flexible cables or cords, which can easily be moved from one place to another while connected to the power mains.

• Functional Connection: an electrical connection for transfer of signals and/or power.

3 Testing and Maintenance

• Tests: Safety or Performance Assurance test procedures which may consist of several steps.

Recommended Frequency

Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements.

Test s Frequency

Preventive Maintenance

Other Regular Tests

Performance Assurance Tests

NBP Performance Once every two years, or more

often if specified by local laws.

Microstream CO2 Calibration

Once a year or after 4000 hours of continuous use and following any instrument repairs or the replacement of any instrument parts.

Tympanic Temperature Calibration Once a year. If the unit is

dropped or damaged, check it and calibrate it before further use.

Visual Inspection Before each use.

Power On Test

ECG/Resp Performance Once every two years, or if you

ECG Out Sync Performance

ECG Sync Pulse Performance

SpO2 Performance

NBP Performance

Invasive Pressure Performance

Temperature Accuracy

1,2

suspect the measurement is incorrect, except Mainstream CO2 Accuracy Check, Sidestream CO2 Accuracy Check and Flow Check and Predictive Temperature Accuracy Check required once a year.

Predictive Temperature Accuracy Check

Mainstream CO2 Accuracy Check

1,2

Sidestream CO2 Accuracy Check and Flow Check

Microstream CO2 Performance Test

Nurse Call Relay Performance

1,2

Power Loss Alarm Buzzer Performance

MSL Assurance Test

1,2

Mounting Integrity Test

Battery Performance

3 Testing and Maintenance

Test s Frequency

Safety Test s

These tests do not apply for MP5T.

These tests do not apply for MP5SC

Visual

Electrical

Visual Inspection After each service event

Protective Earth Once every two years and after

Equipment Leakage Current

Patient Leakage Current

System Test Once every two years

When to Perform Tests

This table tells you when to perform specific tests.The corresponding test procedures are described in the following sections All tests listed below must be performed on the monitor.

Service Event

(When performing...

Installation

Installation of a monitor in combination with a

medical or non-medical device connected to the same multiple socket outlet.

Installation of a standalone monitor with no display connected to the video output

Installation of a monitor with a medical display specified by Philips

Installation of a monitor with an off-the-shelf display (non-compliant with IEC60601-1)

Installation of a monitor with IntelliVue G1/ G5, connected to separate mains sockets.

Installation of monitor with IntelliVue Instrument Telemetry (IIT)

Installation of a monitor with IT equipment e.g. PC connected via a functional connection e.g. Centronics or USB.

Installation of monitor with IntelliVue 802.11 Bedside Adapter

Installation of a monitor with Short Range Radio (SRR)

Installation of networked monitor (LAN) Perform Visual Inspection and Power On Test

repairs where the power supply has been removed or replaced or the monitor has been damaged by impact.

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On and System Tests

Perform Visual Inspection and Power On Test

Perform Visual Inspection, Power On and System Test

Perform Visual Inspection and Power On Tests

Perform Visual Inspection, Power On and IIT communication test

Perform Visual Inspection, Power On and System Tests

Perform Visual Inspection, Power On and IntelliVue 802.11 Bedside Adapter Communication Test

Perform Visual Inspection, Power On and SRR communication test

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Service Event

(When performing...

Tests Required

...Complete these tests)

Preventive Maintenance

Preventive Maintenance* Perform preventive maintenance tests and

procedures:

• NBP calibration

• Microstream CO2 calibration

• Tympanic Temperature Calibration

Other Regular Tests and Tasks

Visual Inspection Perform Visual Inspection

Power On Test Perform Power On test

Repairs

Repairs where the monitor has been damaged by

impact, liquid ingression, fire, short circuit or

Perform Visual Inspection, Power On, all Safety Tests and Full Performance Assurance Tests

electrical surge.

Repairs where the power supply, the mains socket or an interface board is removed or

Perform Visual Inspection, Power On, all Safety

Tests and Basic Performance Assurance Test replaced or the protective earth ground connection is disrupted.

Repairs where the main board has been replaced. Perform Visual Inspection, Power On, Basic

Performance Assurance Test and NBP Accuracy

Test and Calibration.

Repairs where the measurement block has been removed or replaced

Perform Visual Inspection, Power On, all Safety

Tests and Basic Performance Assurance Test.

If a certain parameter seems suspicious, perform

Full Performance Assurance Test for this

parameter.

Repairs where the NBP pump has been replaced Perform Visual Inspection, Power On, all Safety

Tests, Basic Performance Assurance Test and NBP

Performance Test and Calibration

Repairs of IntelliVue Instrument Telemetry (IIT) Module

Perform Visual Inspection, Power On Test Block

and IIT communication test

Repairs of IntelliVue 802.11 Bedside Adapter Perform Visual Inspection, Power On and

IntelliVue 802.11 Bedside Adapter

Communication Test

Repairs of Short Range Radio (SRR) Interface Perform Visual Inspection, Power On and SRR

Communication Test

Repairs of the IntelliVue G1/G5 Perform Basic Performance Assurance Test. For

further testing requirements, see IntelliVue G1/

G5 Service Guide

Repairs where the Quick Mount has been

Perform Mounting Integrity Test disassembled

All other IntelliVue Monitoring System repairs (except when power supply is removed)

Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test

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Service Event

(When performing...

Tests Required

...Complete these tests)

Performance Assurance

Basic Performance Assurance Perform basic performance assurance tests for the

respective monitoring system component.

Full Performance Assurance Perform all accuracy and performance test

procedures listed in the following sections. If a

particular measurement is in question, perform the

measurement performance test only.

Upgrades

Software Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IIT

communication Test

Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IntelliVue 802.11

Bedside Adapter Communication Test

Hardware Upgrades where Short Range Radio (SRR) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and SRR

communication Test

Installation of Interfaces or Hardware Upgrades where the power supply or parameter boards

Perform Visual Inspection, Power On Test, Basic

Performance Tests and all Safety Tests need to be removed.

Combining or Exchanging System Components (non-medical equipment

Perform the System Test for the respective system

components connected to an IntelliVue monitor or medical system equipment operated on a multiple socket outlet)

NOTE

It is the responsibility of the facility operator or their designee to obtain reference values for recurring safety and system tests. These reference values are the results of the first test cycles after an installation. You may also purchase this service from Philips.

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Testing Sequence

Summary of the recommended sequence of testing:

NOTE

If any single test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective.

Visual Inspection

Before Each Use

Check all exterior housings for cracks and damage. Check the condition of all external cables, especially for splits or cracks and signs of twisting. If serious damage is evident, the cable should be replaced immediately. Check that all mountings are correctly installed and secure. Refer to the instructions that accompany the relevant mounting solution.

After Each Service, Maintenance or Repair Event

Ensure all fuses accessible from the outside comply with the manufacturer’s specification.

Check:

• the integrity of mechanical parts, internally and externally.

• any damage or contamination, internally and externally

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

Power On Test

1 Connect the monitoring system to mains and switch it on. This includes connected displays and

gas analyzers.

2 Make sure that all steps listed in the table Initial Instrument Boot Phase in the Troubleshooting section

are completed successfully and that an ECG wave appears on the screen.

The expected test result is pass: the monitor boots up and displays an ECG wave. The wave might be a flat line if no simulator is attached.

Safety Tests

Safety tests are comprised of the following tests performed on the monitoring system:

• protective earth resistance

• equipment leakage current

• applied part leakage current

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• system test (if applicable)

Safety test requirements are set according to international standards, their national deviations and specific local requirements. The safety tests detailed in this Service Guide are derived from international standards but may not be sufficient to meet local requirements. We recommend that you file the results of safety tests. This may help to identify a problem early particularly if the test results deteriorate over a period of time.

Each individual piece of equipment which has its own connection to mains or which can be connected or disconnected from mains without the use of a tool must be tested individually. The monitoring system as a whole must be tested according to the procedure described in “System Test” on page 55.

Accessories which can affect the safety of the equipment under test or the results of the safety test must be included in the tests and documented.

Warnings, Cautions, and Safety Precautions

• These tests are well established procedures of detecting abnormalities that, if undetected, could result in danger to either the patient or the operator.

• Disconnect the device under test from the patient before performing safety tests.

• Disconnect the device under test from mains before performing safety tests. If this is not possible, ensure that the performance of these tests does not result in danger to the safety analyzer operator, patients or other individuals.

• Test equipment (for example, a Safety Analyzer) is required to perform the safety tests. Please refer to Annex C of IEC/EN 62353 for exact requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents. Refer to the documentation that accompanies the test equipment. Only certified technicians should perform safety testing.

• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step to maintain user and patient safety. You can also use the Safety

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Analyzer as a troubleshooting tool to detect abnormalities of line voltage and grounding plus total current loads.

• During safety testing, mains voltage and electrical currents are applied to the device under test. Ensure that there are no open electrical conductive parts during the performance of these tests. Avoid that users, patients or other individuals come into contact with touch voltage.

• For Europe and Asia/Pacific, the monitor complies with: IEC 60601-1:1988 + A1:1991 + A2:1995(Ed.2); EN60601-1:1990 + A1:1993 + A2:1995(Ed.2); IEC 60601-1-1:2001; EN 60601-1-1:2001; IEC 60601-1-2:2001+A1:2004; EN 60601-12:2001+A1:2006. For USA, the monitor complies with: UL60601-1:2003 For Canada, CAN/CSA C22.2#601.1-M90+S1+A2

• Local regulations supersede the testing requirements listed in this chapter.

• If a non-medical electrical device is connected to a medical electrical device, the resulting medical electrical system must comply IEC 60601-1-1:2000/ EN 60601-1-1:2001 or IEC 60601-1:2005/ EN 60601-1:2006+A1:2012 (Ed.3) Section 16 "ME Systems"

• Perform safety tests as described on the following pages.

Safety Test Procedures

Use the test procedures outlined here only for verifying and recording the initial values prior to or at installation, safe installation or service of the product, and for periodic recurrent testing. The setups used for these tests and the acceptable ranges of values are derived from local and international standards but may not be equivalent. These tests are not a substitute for local safety testing where it is required for an installation or a service event. If using an approved safety tester, perform the tests in accordance with the information provided by the manufacturer of the tester and in accordance with your local regulations, for example IEC/EN 60601-1, UL60601-1 (US), IEC/EN 62353, and IEC/EN 60601-1-1. The safety tester should print results as detailed in this chapter, together with other data.

Please refer to Annex C of IEC/EN 62353 for requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents.

The following symbols are used in the diagrams illustrating the safety tests:

Supply mains Protective earth

L, N Supply mains terminals PE Protective earth terminal

Mains part Applied part

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F-type applied part Measuring device

Resistance measuring device Connection to accessible

conductive parts

......... Optional connection

CAUTION

After each service, maintenance or repair event:

Ensure all fuses accessible from the outside comply with the manufacturer’s specification.

Check:

• the integrity of mechanical parts, internally and externally.

• any damage or contamination, internally and externally.

• that no loose parts or foreign bodies remain in the device after servicing or repair.

• the integrity of all relevant accessories.

Hints for Correct Performance of Safety Tests

• Perform a visual inspection on all detachable power cords used with the monitoring system and include these in all safety test procedures.

• Connection lines such as data lines or functional earth conductors may appear to act like protective earth connections. These may lead to incorrect measurements and need to be considered during testing. If necessary, unplug these connections.

• During measurements, the device under test shall be isolated from earth (e.g. test on an insulated work bench), except the protective earth conductor in the power supply cord.

• Position all cables and cords in such a manner that they do not influence the safety tests.

• Measurement of insulation resistance is not required.

• When testing a medical electrical system, where possible, test it such that potential ground voltage variations are present as they may be during actual use.

Guideline for Performance of Safety Tests

This section introduces the general principle of performing recurrent safety tests. Product specific test descriptions are described in the following sections.

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the equipotential connector or unearthed conductive accessible parts where applicable during Equipment Leakage Current Tests and Applied Part Leakage Current Tests. For testing the applied part leakage current, connect all applied parts to the safety analyzer using the appropriate patient lead or adapter cable. For the ECG parameter all ten ECG-leads need to be connected to the safety analyzer. If necessary, use an adapter cable to connect all ten ECG-leads. If necessary, repeat the safety test procedure until all available applied parts have been tested. Refer to the documentation that accompanies the safety analyzer for further details on how to set up and perform the test.

Protective Earth Resistance Test - Setup Example

NOTE

The test lead needs to go to parts that require protective earthing. This may be a single connection or several tested after each other

Equipment Leakage Current Test - Setup Example

NOTE

The test lead needs to go to the grounded enclosure parts, the ungrounded enclosure parts and all of the applied parts connected together.

Applied Part Current Test - Setup Example

NOTE

The above graphics resemble the Metron QA-90 setup and are protected by copyright. Copyright owned by Fluke (Metron).

Safety Test Adapter Cable - Schematics

The following graphics provide schematics of safety test (patient lead) adapter cables which can be used for electrical safety testing. These schematics can also be used as a guideline for making your own safety test adapter cables. Alternatively, other methods to make safety test adapter cables can be used, e.g. using a modified accessory cable.

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NOTE

You may not need all of the cables displayed below for electrical safety testing of your respective monitor.

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ECG

SpO2 (X2 #A01-#A04, M3001AL #A01-#A04, MP2/MP5 #SP1-#SP4)

SpO2 (M1020A)

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Masimo rainbow SET (X2 #A05, M3001AL #A05, MP2/MP5 #SP5)

Invasive Pressure

Invasive Pressure (M1006B #C01)

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Temperature

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CO2 (MP5, M3014A)

CO2 (M1016A, M3016A)

4 = all resistors 120 KOhm

Cardiac Output

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BIS

Use Clamp Adapter Cable and BIS sensor simulator (P/N: M1034-61650, 453563233731).

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VueLink

4 = 220 Ohm

IntelliBridge

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EEG

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SvO2 (M1021A)

ScVO2 (M1011A)

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tcpO2/tcpCO2

MP5 Predictive Temperature

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Tympanic Temperature

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MP5 TAAP

TcG10

S(1): Protective Earth Resistance Test

Test to perform:

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Measuring circuit for the measurement of Protective Earth Resistance in medical electrical equipment that is disconnected from the supply mains.

This measures the impedance of the Protective Earth (PE) terminal to all exposed metal parts of the Device under Test (DUT), which are for safety reasons connected to the Protective Earth (PE).

You can find metal parts of the device at the equipotential connector.

Measurements shall be performed using a measuring device capable to deliver a current of at least 200 mA into 500 mOhms with maximum open circuit voltage of 24V

This safety test is based on IEC/EN 62353.

Report the highest value (X1).

Test Expected test results

Protective Earth Resistance Test (with

X1 <= 300mOhms

mains cable)

NOTE

• If the protective earth resistance test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective.

• All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

• Flex the power cord during the protective earth resistance test to evaluate its integrity. If it does not pass the test, exchange the power cord. Then repeat the test. If it still does not pass, follow the instructions in the first bullet point of this note above.

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S(2): Equipment Leakage Current Test - Normal Condition

Test to perform:

Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353.

This test measures leakage current of accessible conductive and non-conductive metal parts of the monitor and the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 closed (Normal Condition).

There are no parts of the equipment that are not protectively earthed. Disconnect any data cables and any connections that may provide an extraneous earth path. Test the device under test (DUT) on an insulated surface. Do not touch the DUT during testing.

This safety test is based on IEC/EN 62353.

Report the highest value (X1).

Test Expected test results

Equipment Leakage Current Test

X1 <= 100μA

(Normal Condition - with mains cable)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

In case of an IT-power system, this safety test measurement requires a special measuring circuit, for example with its own integrated TN-system or use of an external isolation transformer attached to the safety test device.

S(3): Equipment Leakage Current Test - Single Fault Condition

Test to perform:

Measuring circuit for the measurement of Equipment Leakage Current - Direct method according to IEC/EN 62353.

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This safety test is based on IEC/EN 62353.

Report the highest value (X2).

Test Expected test results

Equipment Leakage Current Test (Single Fault Condition - with mains cable)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

X2 <= 300μA

S(4): Applied Part Leakage Current - Mains on Applied Part

NOTE

During measurement of the Applied Part Leakage Current it is possible that the measured current can exceed the allowed limit (per IEC/EN 60601-1 or IEC/EN 62353).

This can occur when the safety tester is connected to the invasive blood pressure and temperature connectors at the same time during the applied leakage current measurement.

The connectors for the invasive blood pressure and temperature are independently functioning connectors.

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Although there are individual connectors on the front end, internally those parameters use the same electrical insulation interface and are hardwired to each other. This results in an electrical short of those connectors during measurement if a test current is applied simultaneously. Therefore this should be avoided.

Due to the combined insulation interface, it is sufficient to connect to only one parameter interface (that is, Invasive Blood Pressure or Temperature) of the invasive blood pressure/temperature measurement block. This avoids a short and the potential of exceeding the limit for the current.

Test to perform:

Measuring circuit for the measurement of Applied Part Leakage Current - Direct method according to IEC/EN 62353.

There are no parts of the equipment that are not protectively earthed.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003 and

CSA 601.1-M90.

Report the highest value. (X1).

Test Expected test results

Applied Part Leakage Current Test

X1 <= 50μA (CF) (Single Fault Condition - mains on applied part)

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NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

Applied Part Leakage Current - Mains on Applied Part for Tympanic Thermometer on Standalone Base Station

1 Remove the interface and the thermometer cable from the base station.

2 Insert the two safety test cables as shown below.

Cable A (IntelliBridge - 453564127781) and Cable B (Tympanic Temperature - 453564421601)

1 Connect to an appropriate safety tester (e.g. Fluke ESA 620) as shown below.

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Perform the test:

Measuring circuit for the measurement of Applied Part Leakage Current - Direct method according to IEC/EN 62353

This test measures applied part leakage current from applied part to earth caused by external main voltage on the applied part. Each polarity combination possible shall be tested. There are no parts of the equipment that are not protectively earthed. This safety test is based on IEC/EN 60601-1, IEC/ EN 62353, UL2601-1 Ed. 2/UL60601-1:2003 and CSA 601.1-M90. Report the highest value. (X1).

Test Expected test results

Applied Part Leakage Current test (Single Fault

X1 <= 5000 μA (BF)

Condition - mains on applied part)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1 Measurements

Protective Earth resistance (between the PROTECTIVE EARTH TERMINAL and any ACCESSIBLE METAL PART which is PROTECTIVELY EARTHED, w/o power cord):100mOhms

Protective Earth resistance of power cord: 100mOhms

Enclosure leakage current (IEC 60601-1 and UL60601-1): 100 A (N.C.)

Enclosure leakage current:(IEC 60601-1): 500 A (S.F.C)

Enclosure leakage current (UL 60601-1): 300 A (S.F.C)

Patient leakage current: (IEC 60601-1 and UL60601-1): 100 A (N.C.) for BF

Patient leakage current: (IEC 60601-1 and UL60601-1): 500 A (S.F.C.) for BF

Patient leakage current: (IEC 60601-1 and UL60601-1): 10 A (N.C.) for CF

Patient leakage current: (IEC 60601-1 and UL60601-1): 50 A (S.F.C.) for CF

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated

Insulation Resistance

It is not recommended to perform measurements of the insulation resistance. Refer to IEC 62353 for details about methods of the insulation resistance measurement.

System Test

After mounting and setting up a system, perform system safety tests according to IEC/EN 60601-1-1.

What is a Medical Electrical System?

A medical electrical system is a combination of at least one medical electrical piece of equipment and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.

• Devices forming a medical electrical system must comply either with IEC/EN 60601-1-1 or IEC/ EN 60601-1+A1 Ed.3 clause 16.

• Any electrical device such as IT equipment that is connected to the medical electrical equipment must comply either with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 and be tested accordingly.

• Non-medical electrical equipment may require connection through a separating device (e.g. an isolation transformer).

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General Requirements for a System

After installation or subsequent modification, a system must comply with the requirements of the system standard IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Compliance is checked by inspection, testing or analysis, as specified in the IEC/EN 60601-1-1 or in this book.

Medical electrical equipment must comply with the requirements of the general standard IEC/EN 60601-1, its relevant particular standards and specific national deviations. Non-medical electrical equipment shall comply with IEC safety standards that are relevant to that equipment.

Relevant standards for some non-medical electrical equipment may have limits for equipment leakage currents higher than required by the standard IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. These higher limits are acceptable only outside the patient environment. It is essential to reduce equipment leakage currents to values specified in IEC/EN 60601-1 when non-medical electrical equipment is to be used within the patient environment.

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System Example

This illustration shows a system where both the medical electrical equipment and the non-medical electrical equipment are situated at the patient’s bedside.

WARNING

• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Do not place multiple socket-outlets on the floor. Do not exceed the maximum permitted load for multiple socket-outlets used with the system. Do not plug additional multiple socket outlets or extension cords into multiple socket outlets or extension cords used within the medical electrical system.

• Do not connect any devices that are not supported as part of a system.

• Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1 or IEC 60601-1 edition 3 clause 16. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16. Any nonmedical device placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16) that ensures mechanical fixing of the power cords and covering of any unused power outlets.

System Installation Requirements

• Ensure that the medical electrical system is installed in a way that the user achieves optimal use.

• Make sure the user is informed about the required cleaning, adjustment, sterilization and disinfection procedures listed in the Instructions for Use.

• The medical electrical system must be installed in such a way that the user is able to carry out the necessary cleaning, adjustment, sterilization and disinfection procedures listed in the Instructions for Use.

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• Ensure that the medical electrical system is installed in a way that an interruption and restoration of power to any part of the medical electrical system does not result in a safety hazard.

• We recommend using fixed mains socket outlets to power the medical system or parts thereof. Avoid using multiple portable socket-outlets.

• Any multiple portable socket outlets used must be compliant with IEC 60884-1 and IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16.

• Ensure that any part of the system connected to multiple portable socket-outlets is only removable with a tool, i.e. the multiple portable socket-outlet provides a locking mechanism to prevent power cords from being plugged or unplugged unintentionally. Otherwise, the multiple portable socketoutlet must be connected to a separation device. Multiple Socket Outlets used within the medical electrical system must only be used for powering medical electrical equipment which is part of the system.

• Ensure that any functional connections between parts of the medical electrical system are isolated by a separation device according to IEC/EN 60601-1-1 or IEC/EN 60601-1+A1 Ed.3 clause 16 to limit increased equipment leakage currents caused by current flow through the signal connections where necessary (e.g. leakage current coming from non-medical electrical equipment into medical electrical equipment or building ground voltage differences providing leakage current through grounded data cables). This only works if the equipment leakage current of the respective medical electrical system parts is not exceeded under normal conditions. This isolation is especially important where the non-medical electrical equipment leakage currents can pass to the medical electrical equipment in the system or building ground voltage differences can pass to the medical electrical equipment via ground in a data cable connection in the system

• Avoid increase of equipment leakage currents when non-medical electrical equipment within the medical electrical system is used. This only applies when if the equipment leakage current of the respective medical electrical system parts is not exceeded under normal conditions. Use of an additional protective earth connection, separation device or additional non-conductive enclosures are options that can prevent a problem.

• Within the patient environment it is important to limit electrical potential differences between different parts of a system. If necessary, use potential equalization equipment (equipotential cable) or additional protective earth connections.

• Medical electrical equipment used in medical rooms must be connected to potential equalization equipment (equipotential cable) to avoid electrical potential differences. Check your local requirements for details.

Required Protective Measures at System Installation

For any IT equipment (IEC60950-1) operated in the patient environment ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure compliance. After installation of IT equipment in the patient environment, an equipment leakage current test is required.

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Case 1: Medical Device Combined with Medical Device

If you combine a medical device with another medical device (incl. Philips specified displays) to form a medical electrical system according to IEC60601-1-1 or IEC/EN 60601-1 edition 3 clause 16, no additional protective measures are required. The medical electrical devices may be located in or outside the patient vicinity in a medically used room. This is valid as long as the medical devices are connected to separate mains outlets. No system test is required.

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If the combined medical devices are connected to the same multiple portable socket outlet an enclosure leakage current test of the entire device combination on the multiple portable socket outlet is required to ensure that the resulting protective earth leakage current and equipment leakage current does not exceed the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16. Avoid using multiple portable socket outlets. The medical electrical devices may be located in or outside the patient vicinity in a medically used room. If the limits are exceeded, additional protective measures are required, e.g. a separation device or the connection of each device to separate mains.

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Case 2: Medical Device Combined with a Non-Medical Device

If you combine a medical device with a non-medical device to form a medical electrical system according to IEC60601-1-1 or IEC/EN 60601-1 edition 3 clause 16, additional protective measures are required, e.g. usage of a separation device. The medical electrical devices or the IT equipment may be located in or outside the patient vicinity in a medically used room. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current and applied part leakage current does not exceed the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16.

For any IT equipment (IEC60950-1) operated in patient vicinity ensure that the equipment leakage current does not exceed the limits described in IEC 60601-1 or IEC/EN 60601-1 edition 3 clause 16. Use a separation device to ensure compliance. After installation of IT equipment in patient vicinity, an equipment leakage current test is required.

3 Testing and Maintenance

If the combined devices forming the medical electrical system are connected to the same multiple portable socket outlet, ensure that the resulting protective earth leakage current and equipment leakage current do not exceed the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16. The medical electrical devices or IT equipment may be located in or outside the patient vicinity in a medically used room. Avoid using multiple portable socket outlets. If the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16 are exceeded, additional protective measures are required, e.g. a separation device or the connection of each device to separate mains.

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Case 3: Medical Device Combined with a Medical or Non-Medical Device with one Device in a Non-Medically-Used Room

If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC60601-1-1 or IEC/EN 60601-1 edition 3 clause 16 using a common protective earth connection and one of the devices is located in a non-medically used room, additional protective measures are required, e.g. usage of a separation device or additional protective earth connection. The medical electrical devices or IT equipment may be located in or outside the patient vicinity. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current does not exceed the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16.

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If you combine a medical device with a medical or non-medical device to form a medical electrical system according to IEC60601-1-1 or IEC/EN 60601-1 edition 3 clause 16 using two separate protective earth connections and one of the devices is located in a non-medically used room creating a potential voltage difference, additional protective measures are required, e.g. usage of a separation device or additional protective earth connection. The medical electrical devices or IT equipment may be located in or outside the patient vicinity. After system installation incl. protective measures, a system test is required to ensure that the resulting equipment leakage current does not exceed the limits of IEC 60601-1-1 or IEC/EN 60601-1 edition 3 clause 16.

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System Test Procedure

If the medical electrical device has already been tested as a standalone device e.g. during factory safety testing, an equipment leakage current test must only be performed once the device is connected to another electrical device/system. If the medical electrical system has not been tested as a standalone device, the device has to be tested as a standalone device (without connection to the system) and as part of the system (with connection to the system).

Connect the detachable power cord of the device under test to the safety analyzer's test mains port. Connect the enclosure test lead of the safety analyzer to the enclosure of the device under test as described in the "Equipment Leakage Test" section . Refer to the documentation that accompanies the safety analyzer for further details on how to set up the test.

Test Expected test results

Equipment Leakage Current Test (Normal Condition)

Equipment Leakage Current Test (Single Fault Condition)

After the testing of the device as a standalone device and as part of the system, check that the resulting values (without connection and with connection to the system) do not differ by more than +/- 10% from each other.

If the devices in the medical electrical system are connected to a multiple portable socket outlet the resulting protective earth leakage current needs to be determined. All system components must be connected to the multiple portable socket outlet and be switched on during this measurement.

Sys1 <= 100μA

Sys2 <= 300μA

Test Expected test results

Protective Earth Leakage Current of Multiple Socket Outlets

Sys3 <= 300μA

3 Testing and Maintenance

Refer to the documentation that accompanies the safety analyzer for further details on how to set up the test.

Preventive Maintenance Procedures

Noninvasive Blood Pressure Measurement Calibration

Carry out the noninvasive blood pressure measurement performance tests at least every two years , or as specified by local laws (whichever comes first).

Microstream CO2 Calibration

Carry out the Microstream CO2 calibration once a year or after 4000 hours of continuous use and following any instrument repairs or the replacement of any instrument parts.

Tympanic Temperature Calibration

To verify the performance of the Tympanic Thermometer:

1 Purchase a Covidien calibration device, part number 303097. See the Covidien web site for

ordering information (www.covidien.com).

2 Follow the instructions provided with the calibration device to perform the test.

NOTE

The battery compartment in the Tympanic temperature probe is not functional.

CAUTION

After performing the calibration, check the body reference site selection of the Tympanic Thermometer to make sure it matches the required settings for your hospital.

Performance Assurance Tests

Some of the following test procedures must be performed in service mode. To enter service mode

Operating Modes in the main menu. Then select Service Mode and enter the password.

select

If required, open the screen menu in the monitor info line at the top of the screen and select access the service screen. This is required particularly for Anesthetic Gas Module testing procedures.

Basic Performance Assurance Test

This section describes the basic performance test procedure. Please refer to the section “When to Perform Tests” on page 27 for detailed information on when which test procedure is required.

Service to

Procedure:

Power on the monitoring system and go into demo mode. Check that each parameter (incl. Gas Analyzer) displays values.

Full Performance Assurance Test

The following sections describe the full performance testing procedures i.e. detailed testing of each parameter with a patient simulator or specified tools. Please refer to the section for information on when which testing procedure is required.

ECG/Resp Performance Test

This test checks the performance of the ECG and respiration measurements.

Tools required: Patient simulator.

ECG Performance

1 Connect the patient simulator to the ECG/Resp connector on the monitor.

2 Configure the patient simulator as follows:

– ECG sinus rhythm. – HR = 100 bpm or 120 bpm (depending on your patient simulator).

3 Check the displayed ECG wave and HR value against the simulator configuration.

4 The value should be 100bpm or 120 bpm+/- 2 bpm.

3 Testing and Maintenance

Respiration Performance

1 Change the Patient Simulator configuration to:

– Base impedance line 1500 Ohm. – Delta impedance 0.5 Ohm. – Respiration rate 40 rpm or 45 rpm.

2 The value should be 40 rpm +/- 2 rpm or 45 rpm +/- 2 rpm.

Test Expected test results

ECG Performance Test 100bpm +/- 2bpm or

120bpm +/- 2bpm

Respiration Performance Test 40 rpm +/- 2 rpm or

45 rpm +/- 2 rpm

ECG Out Sync Performance Test (not available via TAAP or SRR)

This test checks the performance of ECG synchronization between the monitor and a defibrillator. It only needs to be performed when this feature is in use as a protocol at the customer site.

Tools required:

• Defibrillator with ECG Input.

• Patient simulator.

1 Connect the patient simulator to the ECG connector and the defibrillator to the ECG Sync

Output on the monitor with the ECG Sync cable.

2 Set the patient simulator to the following configuration:

– HR = 100 bpm or 120 bpm (depending on your patient simulator). – ECG sinus rhythm.

3 Switch the defibrillator to simulation mode.

3 Testing and Maintenance

Check that the ECG signal is displayed.

Test Expected test results

ECG Out Performance Test ECG Signal is displayed

ECG Sync Pulse Performance Test

This test checks the performance of the ECG sync pulse synchronization between the MP5 and another medical electrical device. It only needs to be performed when this feature is used at the customer site.

Tools required:

• other medical electrical device, e.g. CT Scanner etc.

•patient simulator

1 Connect the patient simulator to the ECG connector and the other medical electrical device to the

monitor.

2 Set the patient simulator to the following configuration:

– HR = 100 bpm or 120 bpm (depending on your patient simulator). – ECG sinus rhythm.

3 Verify that the connected medical electrical device triggers accordingly.

Test Expected test results

ECG Sync Pulse Performance Test Connected medical electrical device

SpO2 Performance Test

This test checks the performance of the SpO2 measurement.

Procedure for Philips FAST SpO

Tools required: none

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

Test Expected test results

SpO

Performance Test 95% and 100%

Procedure for Nellcor OxiMax SpO

Nellcor recommends that the functionality of this parameter be verified using the SRC-MAX.

A possible performance assurance check requiring no tools would be:

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

value on your finger (this assumes that you are healthy).

triggers as expected

Technology:

transducer to the SpO2 connector.

Technology:

transducer to the SpO2 connector.

Test Expected test results

SpO

Performance Test 95% and 100%

Procedure for Masimo rainbow SET Technology:

Tools required: none

3 Testing and Maintenance

1 Connect an adult SpO

2 Measure the SpO

3 The value should be between 95% and 100%.

transducer to the SpO2 connector.

value on your finger (this assumes that you are healthy).

Test Expected test results

SpO2 Performance Test 95% and 100%

In addition to the SpO

Performance Test procedure described above, the following tests are

recommended when using Masimo rainbow SET technology after a field repair or if the performance of the Masimo rainbow SET board in the MMS is in question.

NOTE

The part numbers listed below are subject to change. All parts required for the tests described in this section must be ordered directly from Masimo.

SET Tester and RRa Simulator:

1 Connect a dual patient cable (Masimo part number 3503) to the board.

2 Connect a Masimo SET tester (Masimo part number 3776) to M15 side of the dual cable.

3 Connect one end of an RRa simulator cable (Masimo part number EQ-12070) to M6 side of the

dual cable.

4 Connect the other end (3.5MM) of the RRa simulator cable (Masimo part number EQ-12070) to a

laptop or PC which contains TR19673A_Appendix_A.wav wave file.

5 Play the wave file and set up the computer per instructions in R-EQ-12070 document.

6 Verify that all enabled parameters are within specified range.

Sensor Port Test Tool:

1 Connect a round connector sensor port test tool (Masimo part number 3494) to the board.

2 Confirm that each LED turns on one at a time and then all LEDs turn on.

Shield Continuity:

1 Connect a shield continuity test cable (Masimo part number 3854) to the board.

2 Using a multimeter, measure the resistance across the red and black banana plugs. Verify that the

resistance is less than 5.

Measurement Validation

NOTE

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor. However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification.

3 Testing and Maintenance

Philips FAST SpO2 Technology

The SpO

accuracy has been validated in human studies against arterial blood sample reference

measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation levels between 70% and 100% SaO

were studied. The population characteristics for those

studies were:

• about 50% female and 50% male subjects

• age range: 19 to 39

• skin tone: from light to dark brown

Pulse rate accuracy has been validated with an electronic pulse simulator.

Nellcor OxiMax Technology

Accuracy specifications are based on controlled hypoxia studies with healthy non-smoking adult volunteers over the specified saturation SpO2 range(s). Pulse oximeter SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are expressed as ± "X" digits. Pulse oximeter equipment measurements are statistically distributed; about two-thirds of pulse oximeter measurements can be expected to fall in this accuracy (ARMS) range. Because scatter and bias of pulse oximeter SpO2 and blood SaO2 comparisons commonly increase as the saturation decreases, and accuracy specifications are calculated from data spanning the stated range, different accuracy values may result when describing partially overlapping ranges.

Subjects used to validate SpO2 measurement accuracies were healthy and recruited from the local population. Comprised of both men and women, subjects spanned a range of skin pigmentations and ranged in age from 18-50 years old.

Oxygen saturation accuracy can be affected by certain environmental, equipment, and patient physiologic conditions (as discussed in the Instructions for Use for the monitor) that influence readings of SpO2, SaO2, or both. Accordingly, observations of clinical accuracy may not achieve the same levels as those obtained under controlled laboratory conditions.

Pulse rate accuracy has been validated with an electronic pulse simulator.

Masimo rainbow SET Technology:

The Masimo rainbow SET Technology with the designated sensors has been validated by Masimo during motion and no motion conditions in human studies against an arterial blood sample reference measured with a CO-oximeter and an ECG monitor. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.

, SpCO, and SpMet accuracy was determined by testing on healthy adult volunteers in the range

SpO

of 60-100% Sp0

, 0-40% SpCO, and 0-15% SpMet against a laboratory CO-Oximeter. SpO2 and

SpMet accuracy was determined on 16 neonatal NICU patients ranging in age from 7-135 days old and weighing between 0.5-4.25 kg. Seventy-nine (79) data samples were collected over a range of 70-100%

and 0.5-2.5% MetHb with a resultant accuracy of 2.9% SpO2 and 0.9% SpMet.

SaO

The Masimo sensors have been validated for motion and no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO

against a laboratory CO-oximeter and ECG monitor. This

variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.

Masimo SET technology with LNOP, LNCS, and M-LNCS sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-

3 Testing and Maintenance

repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO

or minus one standard deviation, which encompasses 68% of the population

The Masimo SET Technology with LNOP Neo, LNCS Neo, and M-LNCS Neo sensors has also been validated for neonatal motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a nonrepetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO

The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.

SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8-17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.

against a laboratory co-oximeter and ECG monitor. This variation equals plus

against a laboratory CO-oximeter and ECG monitor.

For more details please refer to the sensor's directions for use (DfU).

NBP PerformanceTest

This section describes NBP test procedures.The monitor must be in service mode and the screen “Service A” must be selected to perform these tests. The NBP Performance Test consists of:

• NBP Accuracy Test

• NBP Leakage Test

•NBP Linearity Test

•Valve Test

NBP Accuracy Test and Calibration

This test checks the performance of the non-invasive blood pressure measurement. Connect the equipment as shown:

Tools required:

• Reference manometer (includes hand pump and valve), accuracy ±0.8mmHg.

• Expansion chamber (volume 250 ml +/- 10%)

3 Testing and Maintenance

• Appropriate tubing.

In service mode, the systolic and diastolic readings indicate the noise of NBP channels 1 and 2 respectively. When static pressure is applied, the reading in NBP channel 1 should be below 50. The value in parentheses indicates the actual pressure applied to the system.

1 Connect the manometer and the pump with tubing to the NBP connector and to the expansion

chamber.

2 In service mode, select the Setup NBP menu.

3 Select Close Valves: On

4 Raise the pressure to 280 mmHg with the manometer pump.

5 Wait 10 seconds for the measurement to stabilize.

6 Compare the manometer values with the displayed values.

7 Document the value displayed by the monitor (x1).

8 If the difference between the manometer and displayed values is greater than 3 mmHg or when

the NBP pump assembly has been changed, calibrate the NBP measurement. If not, proceed to the leakage test.

9 To calibrate the NBP measurement, select Close Valves off then Calibrate NBP and wait for the

instrument to pump up the expansion chamber.Wait a few seconds after pumping stops until

EnterPrVal is highlighted and then move the cursor to the value shown on the manometer. If one of

the following prompt messages appears during this step, check whether there is leakage in the setup:

– NBP unable to calibrate–cannot adjust pressure – NBP unable to calibrate–unstable signal

10 Press Confirm.

If the INOP NBP Equipment Malfunction message occurs in monitoring mode, go back to service mode and repeat the calibration procedure.

NBP Leakage Test

The NBP leakage test checks the integrity of the system and of the valve. It is required once every two years and when you repair the monitor or replace parts.

1 If you have calibrated, repeat steps 2 to 6 from the accuracy test procedure so that you have 280

mmHg pressure on the expansion chamber.

2 Watch the pressure value for 60 seconds.

3 Calculate and document the leakage test value (x2).

x2 = P1 - P2 where P1 is the pressure at the beginning of the leakage test and P2 is the pressure displayed after 60 seconds. The leakage test value should be less than 6 mmHg.

NOTE

The leakage test value of 6 mmHg applies for an expansion chamber of 250ml. When using a different size of expansion chamber, the expected test result needs to be adapted accordingly. E.g for an expansion chamber of 500ml, the leakage test value should be less than 3 mmHg. All other NBP performance tests are independent of the expansion chamber size.

NBP Linearity Test

1 Reduce the manometer pressure to 150 mmHg.

2 Wait 10 seconds for the measurement to stabilize.

3 After these 10 seconds, compare the manometer value with the displayed value.

4 Document the value displayed by the monitor (x3)

5 If the difference is greater than 3 mmHg, calibrate the MMS or X2 (see steps 9 to 10 in the

accuracy test procedure).

Valve Test

1 Raise the pressure again to 280 mmHg.

2 Select Close valves: Off.

3 Wait five seconds and then document the value displayed. The value should be less than 10 mmHg.

4 Document the value displayed by the monitor (x4).

Test Expected test results

Accuracy test x1 = 280 ± 3mmHg

Leakage test x2 = leakage test value

3 Testing and Maintenance

Difference ≤ 3mmHg

x2 < 6 mmHg (with 250ml expansion chamber)

Linearity test x3 = 150 ± 3mmHg

Difference ≤ 3mmHg

Valve Test x4 = value < 10 mmHg

Invasive Pressure Performance Test

This test checks the performance of the invasive pressure measurement.

Tools required: Patient simulator.

1 Connect the patient simulator to the pressure connector.

2 Set the patient simulator to 0 pressure.

3 Make a zero calibration.

4 Configure the patient simulator as P(static) = 200 mmHg.

5 Wait for the display.

6 The value should be 200 mmHg ± 5 mmHg. If the value is outside these tolerances, calibrate the

Invasive Pressure measurement. If the measurement was calibrated with a dedicated reusable catheter, check the calibration together with this catheter.

Test Expected test results

Invasive Pressure Performance Test 200 mmHg ± 5 mmHg

3 Testing and Maintenance

Temperature Performance Test

This test checks the performance of the temperature measurement.

Tools required: Patient simulator (with 0.1°C or 0.2°F tolerance).

1 Connect the patient simulator to the temperature connector.

2 Configure the patient simulator to 40°C or 100°F.

3 The value should be 40°C ± 0.2°C or 100°F ± 0.4°F.

Test Expected test results

Temperature Performance Test 40°C ± 0.2°C or 100°F ± 0.4°F

Predictive Temperature Accuracy Check

Tools required:

• Calibration Key (CalKey) - Part No. 453564033691

The Calkey can be used to verify correct function of the module (in continuous mode). It does not test the probe. The CalKey contains a known resistance which is converted to a specific temperature by the module.

The monitor can stay in monitoring mode for this procedure.

Procedure:

1 Disconnect the probe and connect the CalKey.

2 Remove the probe from the holder. The monitor software switches to continuous mode

automatically.

3 Observe the displayed temperature. The value should read: 97.3°F ±0.2°F (36.3°C ±0.1°C).

Document whether the predictive temperature module passed or failed the accuracy check.

4 Disconnect the CalKey, connect the probe and return it to the holder.

5 The module test with the CalKey should be performed once a year.

Test Expected test results

Predictive Temperature Accuracy Test 97.3°F ±0.2°F (36.3°C ±0.1°C)

The 9600 Plus Calibration Tester from Welch Allyn provides a convenient way of testing the entire thermometer system, module and probe. It is not intended for use by clinical users. Nevertheless, biomeds or Philips field personnel may use it for probe verification. Currently, the tester is orderable from Welch Allyn only. Follow the instructions provided with the tester.

Mainstream CO2 Accuracy Check

Tools Required:

• three airway adapters

• Verification Gas M2506A

• Gas cylinder regulator M2505A

You also need a local barometric pressure rating received from a reliable local source (airport, regional weather station or hospital weather station) which is located at the same altitude as the hospital.

Procedure:

3 Testing and Maintenance

1 Attach the M2501A CO

sensor to the patient monitor. Attach an airway adapter to the sensor.

Make sure that the sensor is disconnected from the patient circuit.

2 Switch on the patient monitor.

3 Enter the monitor’s Service Mode.

4 Using the sensor status provided in the M2501A Serial protocol, wait for the M2501A sensor to

warm up to its operating temperature.

5 The default setting for gas temperature is 22°C. If the gas temperature is significantly above or

below this value, correct the gas temperature setting.

6 Zero the sensor on the airway adapter being used in this test. Ensure Zero Gas is set to Room Air

7 Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the airway adapter.

8 Set the gas correction to off.

9 Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The expected

value is 5% of the ambient pressure ±2mmHg

NOTE

Make sure that you follow the above steps correctly. If the sensor fails this check it must be exchanged. The sensor cannot be calibrated.

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x1) Acceptance Range

Mainstream CO2 Accuracy

5% of 760 mmHg pressure ±2mmHg 36 mmHg - 40 mmHg

Test

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Sidestream CO2 Accuracy Check

Tools Required:

• Cal gas flow regulator M2267A

• Cal tube 13907A

• Verification Gas M2506A

• Straight Sample Line M2776A

Procedure:

1 Attach the M2741A CO2 sensor to the patient monitor. Attach the sample line and the cal tube to

the sensor. Make sure that the sensor is disconnected from the patient circuit.

2 Switch on the patient monitor.

3 Enter the monitor’s Service Mode.

3 Testing and Maintenance

Using the sensor status provided in the M2741A Serial protocol, wait for the M2741A sensor to warm up to its operating temperature.

5 Zero the sensor. Ensure Zero Gas is set to Room Air

6 Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the cal tube.

7 Set the gas correction to off.

8 Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The expected

value is 5% of the ambient pressure ±2mmHg

NOTE

Make sure that you follow the above steps correctly. If the sensor fails this check it must be exchanged. The sensor cannot be calibrated

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x2) Acceptance Range

Sidestream CO2 Accuracy Test 5% of 760 mmHg pressure ±2mmHg 36 mmHg - 40 mmHg

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Sidestream CO2 Flow Check

Check the flow rate in the Sidestream CO2 extension as follows:

1 Connect the flowmeter to the sample line

2 Check on the flowmeter the flow that the Sidestream CO

ml/min ± 10 ml/min. If the value is not within tolerance check your setup again and perform another flow check. If it fails again, the sensor must be replaced. The sensor cannot be calibrated.

Example for an expected test result:

The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient pressure is:

Test Expected test results (x3) Acceptance Range

Sidestream CO2 Flow Check 50 ml/min ±10 ml/min 40 ml/min - 60 ml/min

NOTE

The expected test results will differ depending on the conditions (i.e. altitude or ambient pressure).

Microstream CO2 Performance Test

Allow five seconds between individual service procedures to ensure stable equipment conditions. When certain monitor procedures are running, service procedures are not possible and trying to start them will result in a message completes the current operation, then restart the service procedure.

Service Operation Failed in the monitor’s status line. Wait until the monitor

extension pump draws. It should be 50

This test checks the performance of the Microstream CO2 measurement. The Microstream CO2 measurement can either be integrated into the IntelliVue MP5 monitor or, for other IntelliVue monitors, into the M3015A/B MMS Extensions. The Microstream CO2 performance test is required

3 Testing and Maintenance

once per year or after 4000 hours of continuous use and when the instrument is repaired or when parts are replaced.

This test uses calibration equipment that you can order (see the Parts section for the part number). The procedure is summarized in the following steps. Refer to the documentation accompanying the equipment for detailed instructions.

Tools Required:

• Standard tools, such as screwdriver, tweezers

• Electronic flowmeter, M1026-60144 or Mass Flowmeter 453564178121

• Digital Barometer ±2mbar or better

• Gas calibration equipment:

• Cal 1 gas 15210-64010 (5% CO

• Cal 2 gas 15210-64020 (10% CO

)

• Cal gas flow regulator M2267A

• Cal tube 13907A

• Calibration Line M3015-47301

• Leakage Test Kit M1013-64002 (451261014851) (only required for leakage test without M102660144 Flowmeter)

• Flexible Connecting Tube

The CO2 calibration for the Microstream extension consists of the following steps:

• Leakage check, either with M1026-60144 Flowmeter or with 453564178121 Mass Flowmeter*

• Barometric pressure check and calibration, if required.*

• Flow check and calibration, if required

•Noise check

• CO2 Cal check and calibration, if required

•CO2 Cal verification

Perform all checks in the same session.

* Not applicable for all HW Revisions. See individual test sections for details.

NOTE

The M3015A/B HW Rev C is indicated as HW Rev. Q.xx.xx in the IntelliVue Revision Screen.

Leakage Check with M1026-60144 Flowmeter (only for M3015A with HW Rev. A and B and Firmware Revision < P.01.32)

The leakage check consists of checking the tubing between:

• the pump outlet and the mCO

• the pump inlet and calibration line inlet.

Check the user’s guide of the flowmeter for details on how to make a correct flow reading.

outlet and

3 Testing and Maintenance

Part 1

1 Go into service mode and select Setup CO2 menu.

2 Connect a calibration line to the Microstream CO

3 Check the ambient pressure and the cell pressure shown in the monitor’s status line. The cell

input to start the pump running.

pressure should be approximately 20 mmHg lower than ambient pressure. (This test is only to check that the pump starts and is running, which is also indicated by the noise generated by the running pump.)

4 Connect the flowmeter outlet to the calibration line inlet using a flexible connecting tube.

5 Block the mCO

outlet using your fingertip and observe the flowmeter display. The value on the

flowmeter (x1) should decrease to between 0 and 4 ml/min, accompanied by an audible increase in pump noise. If the value is within the tolerance limits, continue with part 2 of the leakage check.

6 If the value is outside the tolerance limits, there is a leakage between the pump outlet and the

outlet.

mCO

7 Open the MMS Extension or MP5 and check the tubing connections at the pump outlet and the

extension gas outlet. If the connections are good, then there is a leakage in the tubing and you must exchange the MMS Extension or the mCO

Assembly of the MP5 respectively.

Part 2

1 Disconnect the flowmeter from the Part 1 setup and connect the flowmeter inlet to the M3015A

gas outlet or the MP5 mCO

2 Leave the calibration line connected to the M3015A inlet or the MP5 mCO

3 Block the inlet of the calibration line using your fingertip and observe the flowmeter display. The

gas outlet.

inlet..

value on the flowmeter (x2) should decrease to between 0 and 4 ml/min, accompanied by an audible increase in pump noise. The cell pressure shown in the status line on the display should decrease to between 300 and 500 mmHg. Do not block the inlet for longer than 25 seconds as this will lead to an “Occlusion” INOP. If the value is within the tolerance limits, there are no leakages and the leakage check is completed; proceed to the pump check.

4 If the value is not within the tolerance limits, there is a leakage between the calibration line inlet

and the pump inlet.

5 Check the calibration line connections and open the M3015A or MP5 to check the tubing

connections at the pump inlet and the M3015A or MP5 mCO

gas inlet. If the connections are

good, try replacing the calibration line and repeating the leakage check. If the situation remains, there is a leakage in the tubing and the M3015A or the mCO

assembly of the MP5 must be

exchanged.

Test Expected test results

Leakage Check Parts 1 and 2 x1 = value of part 1 leakage check on flowmeter

(x1< 4.0 ml/min)

x2 = value of part 2 leakage check on flowmeter (x2< 4.0 ml/min)

3 Testing and Maintenance

Leakage Check for M3015B and M3015A with HW Rev C or M3015A with HW Rev. A/B without M1026-60144 Flowmeter

Preparation of Leakage Test Kit:

Remove two Luer connectors from the Leakage Test Kit, as shown in the following picture.

NOTE

These Luer connectors are not required for the actual Leakage Check. However, you should keep them, as they are required for other tests (e.g. for the kit leak test as documented later in this section).

Test Setup:

1 Connect the Calibration Line (M3015-47301) to the inlet of the M8105A/M3015A/B (the

M8105A/M3015A/B must be switched off, either by disconnecting from the host monitor or by switching off the monitor).

2 Connect the leakage test tubing to the outlet of the M8105A/M3015A/B, to the digital barometer,

to the calibration line, and the (empty) syringe as shown below. Make sure all connections have a tight fit!

3 Testing and Maintenance

Test Procedure:

1 Open the 3-way stopcock for all three limbs.

2 Switch on the digital barometer (the digital barometer should now display the actual ambient

pressure).

3 Now slowly draw at the syringe, as if filling the syringe, until the pressure (as displayed on the

digital barometer) drops to approximately 350 mbar below ambient pressure.Then close the line to the syringe at the 3-way stopcock to syringe (circled in picture below).

4 Let the reading on the digital barometer stabilize for a moment and then perform the leakage

check: for 30 seconds the change of the pressure reading should be less than 20 mbar.

5 If the leakage test is NOT passed, check all connections once more and repeat the test.

Test Expected test results

Leakage Check Reading on the digital barometer

change is less than 20 mbar for 30 seconds (pass/fail)

NOTE

To ensure the integrity of the Leakage Test Kit (M1013-64002, 451261014851) the following Kit Leak Test Procedure must be performed:

3 Testing and Maintenance

a. Form a loop with the leakage test kit as shown in the picture below.

b. Connect the syringe to the 3-way stopcock and the digital barometer to the open tubing.

c. Draw at the syringe until the digital barometer shows approximately 350 mbar below ambient

pressure.

d. Close the 3-way stopcock to the syringe and wait 5 - 10 seconds. In this time, the overall

pressure should stabilize.

e. After 1 minute, check the pressure. The pressure should not increase more than 8 mbar in 1

minute for the test to pass.

f. If this test fails, exchange the leakage test kit.

Barometric Pressure Check and Calibration

NOTE

The M3015A with HW Rev C and the M3015B do not require calibration of the barometric pressure. Therefore you will not be able to activate a barometric pressure calibration. If you are using a HW Rev C M3015A or M3015B, perform the barometric pressure check as described below, making sure that only a sample line is connected to the MMS Extension. If the pressure check fails, the M3015A/B needs to be exchanged.

Check the barometric pressure value in the M3015A/B MMS Extension or the MP5 as follows:

1 Go into service mode and select Setup CO

2 Connect a calibration line to the Microstream CO

B MMS Extension or the MP5.

3 The status line at the bottom of the screen displays “CO

yyy” where xxx is the ambient pressure and yyy is the measured cell pressure. Check whether the ambient pressure value (x3) matches (within the acceptable tolerance of ±12mm Hg) the reference value you have received. If so, proceed to the leakage check.

If the value is not correct, calibrate as follows.

a. Select

b. Select the value in the table which matches the reference value received from a reliable local source

(airport, regional weather station or hospital weather station). (The values are displayed with a resolution of 2 mmHg up to 500 mmHg and a resolution of 1 mmHg from 500 mmHg to 825 mmHg.) Note: the selected value must be within ±10% of the current measured ambient pressure, otherwise an error message will occur at restarting the monitor.

then select Barom.Press to activate a table of values.

menu.

input. This activates the pump in the M3015A/

pressure reading (ambient/cell) xxx/

3 Testing and Maintenance

c. Confirm the barometric pressure setting.

d. Check that the ambient pressure displayed in the status line at the bottom of the screen is the same

as the value which you selected from the list in step b.

Test Expected test results

Barometric Pressure Check x3 = difference between the reference

Flow Rate Check and Calibration

Check the flow rate in the M3015A/B MMS Extension or the MP5 as follows:

pressure and the measured ambient pressure displayed on the monitor

(x3<12 mmHg)

1 Connect the calibration line to the mCO

2 Check on the flowmeter the flow that the M3015A/B MMS Extension or MP5 mCO2 pump

inlet and the flowmeter outlet to the calibration line.

draws (x5). It should be 50 +15/-7.5 ml/min. If the value is within tolerance, proceed to the CO Gas calibration check. If the value is not within tolerance, calibrate as follows.

a. Adjust the flow in the instrument by selecting

Increase Flow or Decrease Flow until it is as close as

possible to 50 ml per minute as indicated on the flowmeter gauge.

b. When you are satisfied that the flow is set as close as possible to 50 ml per minute, select

Store Flow

and confirm the setting. If you do not store the adjusted flow within 60 seconds of the adjustment, the old flow setting is restored.

c. If you cannot adjust the flow to within tolerance, replace the pump . If you still cannot make the

flow adjustment, this indicates a fault in the measurement extension, which must be replaced. Note that the pump can only be replaced on M3015A with the old hardware Rev. A (i.e. Serial No.

DE020xxxxx)

Test Expected test results

Flow Rate Check Flow rate is 50 +15/-7.5 ml/min

Noise Check

3 Testing and Maintenance

1 With the monitor in service mode, select Setup CO

2 Connect the calibration line, the cal tube, the flow regulator and the 5% calibration gas to the

inlet.

mCO

menu.

3 Open the valve to apply the 5% calibration gas and wait until the value is stable.

4 Check the noise index (x6) displayed next to the CO

of noise on the CO

wave). If the value exceeds 3 mmHg, replace the measurement extension.

value on the display (this indicates the level

Test Expected test results

Noise Check x6 = noise index displayed on monitor

(x6<3.0)

3 Testing and Maintenance

CO2 Cal Check and Calibration

After switching the measurement extension on, wait at least 20 minutes before checking the calibration. Check the calibration of the CO

1 Connect the calibration line, the cal tube, the flow regulator and the 5% calibration gas to the

inlet.

mCO

gas measurement as follows:

2 Calculate the expected measurement value in mmHg as follows:

0.05 x (ambient pressure) = value mmHg for example 0.05 x 736 = 36.8 mmHg (with an ambient pressure of 736 mmHg)

3 Open the valve on the flow regulator to allow 5% CO

gas to flow into the extension. Allow the

value to stabilize.

4 Check that the value on the instrument (measurement value on the main screen, x7) matches the

calculated mmHg value ± 2.6 mmHg. If the value is outside the tolerance, calibrate as described in step 8a to 8e below.

5 Disconnect the 5% calibration gas and connect the 10% calibration gas.

6 Calculate the expected measurement value and tolerance in mmHg as follows:

0.1 x (ambient pressure) = value mmHg ±0.07 x (value mmHg) = tolerance

for example 0.1 x 737 mmHg = 73.7 mmHg (with an ambient pressure of 737 mmHg) ±0.07 x 73.7 mmHg = ±5.16 mmHg tolerance

7 Open the valve on the flow regulator to allow 10% CO

gas to flow into the extension. Allow the

value to stabilize.

8 Check that the value on the instrument (x8) matches the calculated mmHg value within the

calculated tolerance. If so, the measurement extension is correctly calibrated. If the value is outside the tolerance, calibrate as follows.

a. Keep the same setup and connect the 5% calibration gas.

b. Select

Cal. CO

c. Select the value for the calibration gas. (The default value is 5.0%.)

d. Open the valve on the calibration gas to allow CO2 gas to flow into the extension. Allow the value

to stabilize before the start of the calibration. Leave the valve open until the instrument gives a prompt that gas can be removed.

e. The extension calibrates and prompts when calibration is successful.

Test Expected test results

CO2 Cal Check x7 = calculated mmHg value ±2.6 mmHg

Calibration Verification

1 Keep the same setup as described in “CO2 Cal Check and Calibration” on page 84.

2 Reopen the 5% gas valve and allow the value to stabilize.

3 Check that the value displayed on the monitor is correct within the tolerance (see step above).

4 Disconnect the 5% calibration gas and connect the 10% calibration gas.

5 Open the valve on the flow regulator to allow 10% CO2 gas to flow into the extension. Allow the

value to stabilize.

6 Check that the value displayed on the monitor is correct within the tolerance (see step above).

3 Testing and Maintenance

x8 = calculated mmHg value within calculated tolerance

If one or both values are not within tolerances, you must exchange the M3015A/B MMS Extension or the MP5 mCO

Assembly.

Test Expected Test Results

Leakage Check parts 1 and 2*

x1 = value of part 1 leakage check on flowmeter (x1< 4.0 ml/min)

x2 = value of part 2 leakage check on flowmeter (x2< 4.0 ml/min)

Leakage Check without Flowmeter

Barometric Pressure Check

reading on the digital barometer change is less than 20 mbar for 30 seconds

x3 = difference between the reference pressure and the measured ambient pressure displayed on the monitor

(x3<12 mmHg)

Flow Check x4 = difference between measured value and 50.0 ml/min

(x4 = 50+15/-7.5 ml/min)

Noise Check x5 = noise index displayed on monitor (x5<3.0)

Gas Calibration

Check

x6 = difference between measured CO2 value and calculated value, based on 5% CO

cal. gas. (x6 < 2.6

mmHg)

CO2 Cal Verification x7 = difference between measured CO2 value and

calculated value, based on 10% CO

cal. gas.

(x7 < ± {0.07 x value calculated})

* M3015A HW Rev. B and FW Revision < P.01.32 only

3 Testing and Maintenance

Nurse Call Relay Performance Test

The nurse call relay performance test can be performed either at the phone jack type connector (this only tests one relay) or at the multi-port nurse call connector (to test all three relays).

Phone Jack Type Connector Test (Traditional Nurse Call)

This test checks the operation of the traditional Nurse Call Relay. The Nurse Call Relay test is recommended for customer sites where the nurse call is in use. The Nurse Call relay functions as follows:

• Standard Operation—Relay open.

• Alarm Condition—Relay closed.

Tools required: Ohmmeter.

1 Plug a phono connector into the Nurse Call Relay connector.

2 Connect the ohmmeter.

3 If no alarm occurs, the relay contacts are open. When an alarm occurs, the relay contacts close.

4 The expected test result is: Alarm condition - Relay closed.

Test Expected test results

Nurse Call Relay Performance Test Alarm Condition—Relay closed

Modified MP5 Nurse Call Alarm Relay Test

Some customers may have an Open-On-Alarm relay instead of a Closed-On-Alarm for their Nursecall system.

The modified Nurse Call relay functions as follows:

• Standard Operation—Relay closed.

• Alarm Condition—Relay open.

Tools required: Ohmmeter.

1 Plug a phono connector into the Nurse Call Relay connector.

2 Connect the ohmmeter and verify the above conditions.

3 If no alarm occurs, the relay contacts are closed. When an alarm occurs, the relay contacts open.

The expected test result is: Alarm Condition - Relay open.

Test Expected test results

Nurse Call Relay Performance Test Alarm Condition—Relay open

MSL Assurance Test

Visually inspect all MSL connector sockets (cable/monitor/FMS/MMS).

1 Make sure that the pins of the connectors are not jolted.

2 Make sure that no pin is bent inwards or outwards.

3 Exchange connectors that show any evidence of damage or breakage.

3 Testing and Maintenance

Examples of damaged connectors

Test Expected test results

MSL Assurance Test Pins of connector not jolted/bent

(pass/fail)

Power Loss Alarm Buzzer Performance Test

1 Switch on the monitor.

2 Remove the battery and disconnect the monitor from AC power.

3 The Power Loss Alarm Buzzer should beep for about one minute.

4 To switch off the alarm sound, either press the power button, connect the monitor to AC power or

insert a battery

Test Expected test results

Power Loss Alarm Buzzer Performance Test

Beep for one minute

Battery Performance Test

The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 3 years or 500 charge-discharge cycles, whichever comes first.

In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use.

The age of a lithium ion battery begins at the date of manufacture. To see the date of manufacture and the number of charge-discharge cycles:

3 Testing and Maintenance

Select the battery symbol on the patient monitor screen.

2 Select the appropriate Battery pop-up key.

3 If necessary, select the Battery pop-up key again to view the battery details.

The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen.

Provide customer with details about age of battery and recommend replacement, if necessary.

Test Expected test results

Battery Performance Test Battery age less than 3 years or 500 charge/discharge cycles

IntelliVue 802.11 Bedside Adapter Communication Test - Rev G.0 or lower (not for MP5T)

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Service Mode and select Main Setup -> Network -> Setup WLAN. In the Setup WLAN menu:

–set

–set – set the

– set the Security Mode to match your installation. – Enter the required keys/passwords.

Mode to either 802.11Ah, 802.11G, 802.11Bg (not recommended), Auto (not

recommended) or

None (this setting disables the wireless LAN functionality permanently), to

match your wireless infrastructure installation.

SSID to match your installation.

Country code to “1000”. Setting the country code to this value will automatically adjust

the regulatory domain to match the configuration of the infrastructure. Do not set the country code to values other than “1000” unless otherwise instructed.

3 Select Main Setup -> WLAN Diagnostic to access the service window.

4 Proper installation of the IntelliVue 802.11 Bedside Adapter is assured by connecting to an access

Conn.Status field in the service window shows Authenticatd

(for Rel. C.0 monitors) or Connected (for Rel D.0 or higher). Take the monitor approximately 5 m

away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

RSSI value will fluctuate but should stay above 30 in a 5 m distance from the access point used.

The wireless link should be active, i.e. the

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

Conn.Status field should be Authenticatd (for Rel. C.0

monitors) or Connected (for Rel D.0 or higher), and the other fields should contain values. If the

RSSI value is significantly lower, check the distance to the access point and the antenna

orientation at the monitor. The antenna orientation should be vertical, but the physical placement of the monitor or other equipment within its vicinity as well as walls or other obstacles may influence the antenna orientation required to receive the best RSSI value.

5 If this test fails, retry in a different physical area with a different access point and/or check the

credential settings in the monitor.

Test Expected test results

IntelliVue 802.11 Bedside Adapter

RSSI value above 30

Performance Test

3 Testing and Maintenance

IntelliVue 802.11 Bedside Adapter Communication Test - Rev H.0 or higher (not for MP5T)

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Service Mode and select Main Setup -> Network -> Setup WLAN. In the Setup WLAN menu:

–set

–set – set the

– set the – Enter the required keys/passwords.

3 Select Main Setup -> Network -> WLAN Diagnostic to access the WLAN Diagnostic window.

4 Proper installation of the IntelliVue 802.11 Bedside Adapter is assured by connecting to an access

point over the wireless link. Place the monitor with the IntelliVue 802.11 Bedside Adapter installed in close proximity to the access point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait until the (for Rel. C.0 monitors) or Connected (for Rel D.0 or higher). Take the monitor approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

Mode to either 802.11Ah, 802.11G, 802.11Bg (not recommended), Auto (not

recommended) or

None (this setting disables the wireless LAN functionality permanently), to

match your wireless infrastructure installation.

SSID to match your installation.

Country code to “1000”. Setting the country code to this value will automatically adjust

the regulatory domain to match the configuration of the infrastructure. Do not set the country code to values other than “1000” unless otherwise instructed.

Security Mode to match your installation.

Conn.Status field in the service window shows Authenticatd

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

RSSI value will fluctuate but should stay above 30 in a 5 m distance from the access point used.

The wireless link should be active, i.e. the

Conn.Status field should be Authenticatd (for Rel. C.0

monitors) or Connected (for Rel D.0 or higher), and the other fields should contain values. If the

RSSI value is significantly lower, check the distance to the access point and the antenna

5 If this test fails, retry in a different physical area with a different access point and/or check the

credential settings in the monitor.

Test Expected test results

IntelliVue 802.11 Bedside Adapter

RSSI value above 30

Performance Test

IIT Communication Test - Rev G.0 or lower (not for MP5T)

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Configuration mode and, in the Network menu, set the RF Access Code in each profile to

match your installation.

3 Go into Service Mode. Select Main Setup -> Instr. Telemetry to access the Instrument Telemetry

Service window.

4 Proper installation of the IIT module is assured by connecting to an access point over the wireless

link. Place the monitor with the IIT module installed in close proximity to the access point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait until the

3 Testing and Maintenance

Conn.Status field in the Instrument Telemetry Service window shows Active. Take the monitor

approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

RSSI value should be around -50 ±10 in a 5 m distance from the access point used and the IIT

link should be active, i.e. the contain values. If the and the antenna orientation at both the monitor and the access point (both should be vertical).

– Remove the antenna. The

the connection could be unreliable. The Seeking. If the difference between the significantly lower, check the antenna and the antenna connector for damage and verify that the cable from the IIT adapter to the antenna connector plate is connected properly.

5 If this test fails, retry in a different physical area with a different access point.

Error Conditions: –The field MAC Instr. Tele should show a value unequal to 0000 0000 0000. If it does not, there

is a communication problem between the monitor and the IIT adapter.

– With an incorrect RF Access Code or an incorrect or defective antenna installation, the fields

IP Address,Server IP, Subnet Mask, and RSSI in the Instrument Telemetry Service window will

stay blank. The field

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

Conn.Status field should be Active and the other fields should

RSSI value is significantly lower, check the distance to the access point

RSSI value should be around -90 ±10. The IIT link may be active but

Conn. Status field may toggle between Inactive and

RSSI values measured with and without antenna is

Conn. Status will slowly toggle between Inactive and Seeking.

6 Perform the Access Point Controller (APC) test blocks as described in the Philips IntelliVue

Wireless Network Installation and Configuration Guide.

Test Expected test results

IIT Communication Test IIT Communication without

interference

IIT Communication Test - Rev H.0 or higher (not for MP5T and MP5SC)

1 Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the

monitor.

2 Go into Service mode and, select Main Setup -> Network -> Setup IIT. In the Setup IIT menu, set

RF Access Code in each profile to match your installation.

the

3 Go into Service Mode. Select Main Setup -> Network -> IIT Diagnostic to access the Instrument

Telemetry Diagnostic window.

4 Proper installation of the IIT module is assured by connecting to an access point over the wireless

link. Place the monitor with the IIT module installed in close proximity to the access point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait until the

Conn.Status field in the Instrument Telemetry Service window shows Active. Take the monitor

approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

– Observe the

RSSI value should be around -50 ±10 in a 5 m distance from the access point used and the IIT

link should be active, i.e. the contain values. If the and the antenna orientation at both the monitor and the access point (both should be vertical).

– Remove the antenna. The

the connection could be unreliable. The

RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds. The

Conn.Status field should be Active and the other fields should

RSSI value is significantly lower, check the distance to the access point

RSSI value should be around -90 ±10. The IIT link may be active but

Conn. Status field may toggle between Inactive and

Seeking. If the difference between the RSSI values measured with and without antenna is significantly lower, check the antenna and the antenna connector for damage and verify that the cable fom the IIT adapter to the antenna connector plate is connected properly.

5 If this test fails, retry in a different physical area with a different access point.

Error Conditions:

–The field MAC IIT should show a value unequal to 0000 0000 0000. If it does not, there is a

communication problem between the monitor and the IIT adapter.

– With an incorrect RF Access Code or an incorrect or defective antenna installation, the fields

IP Address,Server IP, Subnet Mask, and RSSI in the Instrument Telemetry Service window will

stay blank. The field

6 Perform the Access Point Controller (APC) test blocks as described in the Philips IntelliVue

Conn. Status will slowly toggle between Inactive and Seeking.

Wireless Network Installation and Configuration Guide.

Test Expected test results

IIT Communication Test IIT Communication without

interference

Short Range Radio (SRR) Performance Test

1 Make sure that the short range radio interface is configured as follows: SRR On and appropriate

channel selected.

3 Testing and Maintenance

2 Assign a telemetry transceiver or IntelliVue CL Cableless Measurement device to the IntelliVue

Monitor according to the procedure described in the Instructions for Use of the patient monitor.

3 Check that the following conditions are fulfilled:

a. Place the telemetry transceiver or CL device close to the monitor.

b. The telemetry transceiver or CL device status is displayed on the monitor in the measurement

selection window.

c. Waves or numerics from the telemetry transceiver or CL device are displayed on the monitor.

There are no dropouts or gaps in waves or numeric transmission.

d. The battery status of the telemetry transceiver or CL device is displayed in the measurement

selection window.

e. The Signal Quality Indicator shows at least

4 Check that the data from the telemetry transceiver or CL device is transmitted to the monitor

within a 1m radius and that there are no dropouts or gaps in waves or numerics.

5 Check whether the connection remains stable within a 5m radius from the monitor.

6 Switch on all telemetry transceivers or CL devices used on the site and check that there are no

interferences between the transceivers and their assigned monitors.

7 Check and record the coverage area of the telemetry transceivers or CL devices and inform the

customer about this coverage area.

Test Expected test results

Short Range Radio (SRR) Performance Test

SRR Communication without interference within the coverage

3 Testing and Maintenance

Mounting Integrity Test

Perform the Mounting Integrity Test

– whenever you have removed and reassembled a quick mount – if one or more of the quick mount screws are loose – if the monitor mounting is unstable

Remove the monitor from the mount and disassemble the quick mount. Ensure that the threaded inserts of the MP5 chassis are not damaged.

If the quick mount is damaged, exchange the quick mount.

Ensure that all quick mount screws are tight (1.3 Nm). Test the quick mount by pressing the quick release button. If it comes back out gradually and regularly, the quick mount is inserted correctly. If it gets stuck, check whether the quick mount is assembled correctly.

Test Expected test results

Mounting Integrity Test All quick mount screws are tight. No

Reporting of Test Results

damage to quick mount. No damage to threaded inserts of the MP5.

Philips recommends all test results are documented in accordance with local laws. Authorized Philips personnel report the test result back to Philips. While hospital personnel (biomedical engineers or technicians) do not need to report results to Philips, Philips recommends that they record and store the test results in accordance with local laws.

The following table lists what to record after completing the tests in this chapter. Record the results in the empty column in the Test and Inspection Matrix.

The following is a guide as to what your documentation should include:

• Identification of the testing body (for example, which company or department carried out the tests).

• Name of the person(s) who performed the tests and the concluding evaluation.

• Identification of the device(s) and accessories being tested (serial number, etc.).

• The actual tests (incl. visual inspections, performance tests, safety and system tests) and measurements required

• Date of testing and of the concluding evaluation.

• A record of the actual values of the test results, and whether these values passed or failed the tests.

• Date and confirmation of the person who performed the tests and evaluation.

The device under test should be marked according to the test result: passed or failed.

Carrying Out and Reporting Tests

Test Report

3 Testing and Maintenance

Testing Organization:

Name of testing person:

Date:

Responsible Organization:

Device Under Test: ID-Number

Product Number: Serial No.:

Accessories:

Measurement Equipment (Manufacturer, Type, Serial No., Calibration Date):

Safety Test Method used

Functional Test (parameters tested):

Mains voltage and frequency used during safety testing:

(Check one of the following three options) Test before putting into service (reference value) Recurrent Test Test after Repair

Test and Inspection Matrix

Test Test or Inspection

to be Performed

Expected Test Results Record the Results (mandatory for

Philips Personnel only)

What to record Actual Results

Visual Inspection

Power On Power on the unit.

Noninvasive Blood Pressure Performance Tests

Temperature Performance Test

Perfor m Visual Inspection

Does the self-test complete successfully

Perfor m the Accuracy Test

Performance Leakage Test

Performance Linearity Test

Performance Valve Test

Perfor m the Temperature Performance Test

Pass or Fail V:P or V:F

If Yes, Power On test is passed PO:P or PO:F

X1 = value displayed by monitor

Difference <= 3mmHg

X2 = leakage test value

X2 < 6 mmHg

X3 = value displayed by monitor

Difference <= 3mmHg

X4 = value < 10 mmHg PN:P/X4 or

X1= 40°C ± 0.2°C or 100°F ±

0.4°F

PN:P/X1 or

PN:F/X1

PN:P/X2 or

PN:F/X2

PN:P/X3 or

PN:F/X3

PN:F/X4

PT: P/X1 or

PT: F/X1

3 Testing and Maintenance

Test Test or Inspection

to be Performed

Expected Test Results Record the Results (mandatory for

Philips Personnel only)

What to record Actual Results

All other performance tests

Perfor m the remaining parameter

See expected results in test procedures

P: P or

P: F

performance tests, if applicable

Safety (1) Perform Safety Test

(1): Protective Earth Resistance

Safety (2) Perform Safety Test

(2): Equipment Leakage Current -

With mains cable: Maximum impedance (X1): <=300 mOhms

With mains cable: Maximum leakage current (X1):<= 100 μA

S(1):P/X1 or

S(1):F/X1

S(2): P/X1 or

S(2): F/X1

Normal Condition.

Safety (3) Perform Safety Test

(3): Equipment Leakage Current -

With mains cable: Maximum leakage current (X2):<= 300 μA

S(3): P/X2 or

S(3): F/X2

Single Fault Condition (Open Earth)

Safety (4) Perform Safety Test

(4): Applied Part Leakage Current -

Maximum leakage current (X1): <=50 μA (CF)

S(4): P/X1 or

S(4): F/X1

Single Fault Condition, mains on applied part.

System (Sys 1-2)

Perform the system test according to subclause 19.201 of IEC/EN 60601-1-1 or IEC/EN 606011+A1 Ed.3 clause

Equipment Leakage Current:

Sys1 <= 100 μA (Normal Condition)

Sys2 <= 300μA (Single Fault Condition

Sys: PSys1/PSys2

Sys: FSys1/Fsys2

16, if applicable, after forming a system

System (Sys 3)

Perform the system test according to subclause 19.201 of IEC/EN 60601-1-1 or IEC/EN 606011+A1 Ed.3 clause 16, if applicable,

Protective Earth Leakage Current if medical electrical system components are connected to the same Multiple Portable Socket Outlet:

Sys3 <= 300 μA

Sys: PSys3

Sys: FSys3

after forming a system

Key: P = Pass, F = Fail, X or Sys = test value to be recorded, * = Record the worst-case results and the associated switch positions (e.g. normal/reverse polarity)

NOTE

All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.

Evaluation

Safety and Functional Test passed

Repair required at a later date, safety and functional test passed

Device must be taken out of operation until repair and passed tests

Device failed and must be taken out of operation.

Notes:

Next Recurrent Test:

Name:____________________________________________________

Date/Signature:_____________________________________________

3 Testing and Maintenance

Yes No

Evaluation of Test Results

The evaluation of the test results must be performed by appropriately trained personnel with sufficient product, safety testing and application knowledge.

If any test results are between 90% and 100% of the respective expected result, the previously measured reference values must be taken into consideration for the assessment of the electrical safety of the device under test. If no reference values are available, you should consider shorter intervals between upcoming recurrent tests.

NOTE

If any single test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective. Be sure to inform the user about the test failure in writing.

Other Regular Tests

The care and cleaning requirements that apply to the monitor and its accessories are described in the Instructions for Use. This section `details periodic maintenance procedures recommended for the monitor and its accessories.

Touchscreen Calibration

To access the touchscreen calibration screen:

1 Enter service mode

2 Select Main Setup

3 Select Hardware

3 Testing and Maintenance

Select Touch Calibration

Touchscreen Calibration Screen

Make sure you complete the calibration procedure without powering off the monitor mid-way. If the monitor is powered off after the first point is touched, the touch panel will be deactivated until the touch calibration is performed again.

If the touchscreen is accidentally mis-calibrated by selecting the wrong spot, you must use another input device to re-enter calibration mode. If you have the Support Tool, you can initiate a touch calibration from there.

Please refer to the documentation shipped with your selected display for further details on touchscreen calibration procedures.

Disabling/Enabling Touch Operation

To temporarily disable touchscreen operation of the monitor, press and hold the Main Screen key. A padlock symbol will appear on the key. Press and hold the touchscreen operation.

Main Screen key again to re-enable

Printer Test Report

To verify your printer configuration you may want to print a test report.

To print a test report select

Your test report should look like this:

Main Setup -> Reports -> Setup Printers -> Print Test Rep.

3 Testing and Maintenance

Battery Handling, Maintenance and Good Practices

This section provides some information on how to handle and maintain the battery in order to get the best usage from them. Additionally, some good working practices are also given regarding the correct disposal of the batteries. This section only applies if a system interface board with battery functionality is installed in the monitor.

NOTE

If your monitor is connected to an IntelliVue Information Center, you should make sure that the IIC uses the text catalog revision E.0 or later, otherwise battery INOPs may not display correctly on the IIC. Consult your IIC documentation for instructions on upgrading the text catalog.

Battery Care

Battery care begins when you receive a new battery 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 into the

Charge the battery Upon receipt, after use, or if a low

Condition the battery When the "battery requires

monitor

battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.

maintenance" symbol appears

3 Testing and Maintenance

Activity When to Perform

Store the battery in a state of charge in the range of 40% to 50%

Refer to your monitor's Instructions for Use for details on how to perform battery care activities, including charging and conditioning. We recommend using the Philips Smart Battery Conditioner LG 1480 (865432)

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 property damage.

• Do not short circuit - take care that the terminals do not contact metal 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 which may not be visible externally

• Do not apply reverse polarity

• Do not expose batteries to liquids

• Do not incinerate batteries or expose them to temperatures above 60°C (140°F)

• Do not attempt to disassemble a battery.

If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:

When not in use for an extended period of time

Storage

• discontinue use

• dispose of the battery in accordance with the disposal instructions

If a battery shows damage or signs of leakage, replace it immediately. Do not use a faulty battery in the monitor.

When storing 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 place, ideally at 15°C (60°F), with a state of charge of 20% to 40%. Storing batteries in a cool place slows the aging process.

The batteries should not be stored at a temperature outside the range of -20°C (-4°F) to 60°C (140°F).

Do not store batteries in direct sunlight.

Stored batteries should be partially charged to 20% to 40% of their capacity every 6 months. They should be charged to full capacity prior to use.

NOTE

Storing batteries at temperatures above 38°C (100°F) for extended periods of time could significantly reduce the batteries’ life expectancy.

Battery Lifetime Management

The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 3 years or 500 full charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 3 years or 500 full charge-discharge cycles.

The age of a lithium ion battery begins at the date of manufacture. To see the date of manufacture and the number of charge-discharge cycles:

1 Select the battery symbol on the patient monitor screen.

2 Select the appropriate Battery pop-up key.

3 If necessary, select the Battery pop-up key again to view the battery details.

The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen.

WARNING

The risk of battery failure increases with age, when a battery remains in use longer than 3 years or 500 full charge-discharge cycles. Such failures can result in overheating that in rare cases can cause the battery to ignite or explode.

3 Testing and Maintenance

Disposal

Batteries should be disposed of in an environmentally-responsible manner. Consult the hospital administrator or your local Philips representative for local arrangements.

Discharge the batteries and insulate the terminals with tape before disposal. Dispose of used batteries promptly and in accordance with local recycling regulations.

About the Battery

The rechargeable Lithium-Ion batteries used in the monitor are regarded as Smart batteries because they have built-in circuitry. (This circuitry communicates battery status information to the monitor.)

Capabilities of integrated battery charger: 12.6V, 5 Amps max.

Actual current/voltage: depends on smart battery request and monitor configuration. The approximate charging time is 4 hours with the monitor switched off and up to 12 hours during monitor operation, depending on the monitor configuration.

NOTE

Batteries will discharge within about 20 days if they are stored inside the monitor without AC power connection.

Checking the Battery Status

When the Monitor is connected to the AC power supply, the battery charges automatically. The battery can be charged remotely from the Monitor by using the battery charger. Use only the 865432 Smart battery conditioner.

Battery status (level of charge) is indicated in several ways:

• LED on the front panel of the Monitor.

3 Testing and Maintenance

• Battery gauge.

• Display of battery time below gauge.

• Battery status window.

• INOP messages.

The AC Power LED is only on when the power cord is connected and AC power is available to the Monitor. In this case, the battery can be either charging or fully charged.

The battery LED can be green, yellow, or red depending on the following conditions:

Battery LED Colors If the monitor is connected to

AC power, this means

Green

Yellow

Red, flashing

Red, flashes intermittently

1 indicated by malfunction symbol and INOP 2 for further details see Troubleshooting section

battery full (≥90%)

battery charging (battery power < 90%)

battery or charger malfunction1,2 battery or charger malfunction1,2

Battery Status on the Main Screen

Battery status information can be configured to display permanently on all Screens. It shows the status of the battery and the battery power and battery time remaining. The battery time is only displayed when the monitor is not running on AC power. Note that the battery status information may take a few minutes after the monitor is switched on to stabilize and show correct values.

Battery power gauge:

If the monitor is running on battery power, this means

≤ 10 minutes power remaining

100

This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three and a half sections are shaded, as in this example, this indicates that 70% battery power remains. If no battery is detected, the battery gauge is greyed out.

Battery malfunction symbols:

If a problem is detected with the battery, these symbols are displayed. They may be accompanied by an INOP message or by a battery status message in the monitor information line (if battery window is open) providing more details.

Battery Status Symbols

Battery requires maintenance

Battery is empty

Philips Intellivue MP5 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

Who Should Use This Guide

How to Use This Guide

Abbreviations

Responsibility of the Manufacturer

Passwords

Warnings and Cautions

2Theory of Operation

Monitor Theory of Operation

System Boundaries

Hardware Building Blocks

IntelliVue MP5/MP5T/MP5SC

Optional Hardware

Power Distribution

System Interfaces

Compatible Devices (not for MP5T and MP5SC)

Data Flow

Data Acquisition

Data Provider System Service

Persistent Data Storage System Service

Display and User Interface Service

Monitor Applications

Internal LAN (Measurement Link)

Microstream CO2

Philips Clinical Network

How does the Support Tool Work with the Monitor

Monitor Software Block Diagram

Block Diagram Legend

3Testing and Maintenance

Introduction

Terminology and Definitions

Recommended Frequency

When to Perform Tests

Testing Sequence

Visual Inspection

Before Each Use

After Each Service, Maintenance or Repair Event

Power On Test

Safety Tests

Warnings, Cautions, and Safety Precautions

Safety Test Procedures

Hints for Correct Performance of Safety Tests

Guideline for Performance of Safety Tests

Safety Test Adapter Cable - Schematics

SpO2 (X2 #A01-#A04, M3001AL #A01-#A04, MP2/MP5 #SP1-#SP4)

SpO2 (M1020A)

Masimo rainbow SET (X2 #A05, M3001AL #A05, MP2/MP5 #SP5)

Invasive Pressure

Invasive Pressure (M1006B #C01)

Temperature

CO2 (MP5, M3014A)

CO2 (M1016A, M3016A)

Cardiac Output

VueLink

IntelliBridge

SvO2 (M1021A)

ScVO2 (M1011A)

tcpO2/tcpCO2

MP5 Predictive Temperature

Tympanic Temperature

MP5 TAAP

TcG10

S(1): Protective Earth Resistance Test

S(2): Equipment Leakage Current Test - Normal Condition

S(3): Equipment Leakage Current Test - Single Fault Condition

S(4): Applied Part Leakage Current - Mains on Applied Part

Applied Part Leakage Current - Mains on Applied Part for Tympanic Thermometer on Standalone Base Station

Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1 Measurements

Insulation Resistance

System Test

What is a Medical Electrical System?

General Requirements for a System

System Example

System Installation Requirements

Required Protective Measures at System Installation

Case 1: Medical Device Combined with Medical Device