Philips Intellivue MP5 User manual

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Service Manual

IntelliVue Patient Monitors

MP5/MP5T

Rel. G.0

Patient Monitoring

Part Number 4535 641 80621 Printed in Germany 10/09

4535 641 80621

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 57 Preventive Maintenance Procedures 68 Performance Assurance Tests 69 Reporting of Test Results 85 Other Regular Tests 89 Touchscreen Calibration 89 Disabling/Enabling Touch Operation 90 Printer Test Report 90 Battery Handling, Maintenance and Good Practices 91 After Installation, Testing or Repair 97

4 Troubleshooting 99

Introduction 99 How To Use This Section 99 Who Should Perform Repairs 99 Replacement Level Supported 99 Software Revision Check 100 Obtaining Replacement Parts 101 Troubleshooting Guide 101

5 Repair and Disassembly 133

Who Should Perform Repairs 133 Tools required 134 Removing the Handle or Bedhanger 134 Removing the Predictive Temperature Assembly 135 Disassembling the Predictive Temperature Assembly 137 Separating the Front and Back of the Monitor 139 Removing the Recorder Slot Cover 143 Removing the Internal Quick Mount Solution 144 Removing the Short Range Radio (SRR) Interface 144 Removing the IntelliVue 802.11 Bedside Adapter Antenna or IIT Antenna (not for MP5T)146 Removing the IntelliVue 802.11 Bedside Adapter (WLAN) (not for MP5T) 147 Removing the IntelliVue Instrument Telemetry (IIT) Module (not for MP5T) 150 Removing the IntelliVue 802.11 Bedside Adapter/IIT Holder (not for MP5T) 151 Removing the MSL Board (not for MP5T) 152 Removing the Backlight Inverter Board 153 Removing the Power Supply 155 Removing the System Interface Board 156 Removing the Recorder Board 157 Removing the Microstream CO2 Assembly 159 Removing the Measurement Block 165 Removing the NBP Pump 169 Removing the Main Board 171 Removing the Touch Assembly 174 Removing the Loudspeaker 176 Removing the Power Button and LED Assembly 176 Removing the LCD Panel 178 Exchanging the Backlight 179 Modifying the Nurse Call Relay 179

6 Parts 183

MP5/MP5T Parts 183 External Display Part Numbers (not for MP5T) 196

7 Installation Instructions 199

Out-Of-Hospital Transport - Standards Compliance 199 Electromagnetic Emissions 201 Electromagnetic Interference (SRR) 201 Installation Checklist 202 Unpacking and Checking the Shipment 202 Installing the Predictive Temperature Probe 204 Mounting the Monitor 205 Connecting the Monitor to AC Mains 210 Checking Out The Monitor 210 Loading Paper 212 Configuration Tasks 213

Handing Over the Monitor 216 Installing Remote Devices (not for MP5T) 216 Philips Clinical Network (Wired) (not for MP5T) 218 Philips Clinical Network (Wireless) (not for MP5T) 218 Philips IntelliVue Information Center 219 IntelliVue Instrument Telemetry (IIT)(not for MP5T) 219 Short Range Radio 220 Connecting the MP5 to a Host Monitor (not for MP5T) 222 Nurse Call Relay (not for MP5T) 223 ECG Out Functionality (ECG Sync) (not for MP5T) 223 ECG Sync Pulse (not for MP5T) 224

8 Site Preparation 225

Introduction 225 Monitor Site Requirements 227 Remote Device Site Requirements 229 Philips Medical LAN 232 RS232/MIB Interface 233 Telemetry Device (Patient Worn Device) cables 233 Nurse Call Relay Interface 234 ECG Out Interface 234

9 Gas Analyzers (not for MP5T) 235

10 MP5 Product Structure 237

Upgrades 242

11 Default Settings Appendix 245

Country-Specific Default Settings 245

Index 255

This Service Guide contains technical details for the IntelliVue MP5/MP5T 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.

1Introduction

How to Use This Guide

This guide is divided into eight sections. 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. In addition, scrolling through the topics with the page up and page down keys is also possible.

Abbreviations

Abbreviations used throughout this guide are:

Name Abbreviation

IntelliVue MP5/MP5T 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

1Introduction

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

• 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.

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 Patient Monitor:

• displays real-time data

• alarms in the case of patient or equipment problems

• offers limited data storage and retrieval (trending)

• interfaces to the Philips Clinical Network and other equipment (not MP5T)

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

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

Functionality (including optional features) MP5 MP5T

ECG yes no

SpO2 yes yes

NBP yes yes

Predictive Temperature yes yes

Temperature yes no

Invasive Pressure yes no

Carbon Dioxide yes no

Microstream CO

Direct Telemetry Connection yes yes

ECG Output signal yes no

LAN networking capability yes no

WLAN networking capability yes no

IntelliVue Instrument Telemetry networking capability yes no

Short Range Radio capability yes yes

yes no

2 Theory of Operation

NOTE

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

Functionality (including optional features) MP5 MP5T

Severe Sepsis Screening yes no

OxyCRG high resolution trend yes no

Neonatal event review yes no

Integrated recorder yes yes

Drug Calculator yes yes

Gas monitor support yes no

Connection to a host monitor (companion mode) yes no

Connection to an external display yes no

Nurse call capability yes no

System Boundaries

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

2 Theory of Operation

Figure 1 System Boundaries

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 does not include all the hardware components shown below):

Figure 2 MP5 Hardware Building Blocks

IntelliVue MP5/MP5T

The MP5/MP5T 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

Figure 3 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

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

The MP5T is delivered only with the battery 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

#J40

Compatible Devices

Figure 4 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.

Figure 5 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/MP5T 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/MP5T and the host monitor, for example:

2 Theory of Operation

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

• 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/MP5T does not support any MMS on the MSL.

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.

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

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.

2 Theory of Operation

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

Figure 6 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)

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)

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)

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

2 Theory of Operation

Functional Block Description

IIT (not for MP5T)

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 and MP5T monitors with an IntelliVue Instrument Telemetry Transceiver.

MSL (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

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 Vicinity: 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 vicinity 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.

Table 1 Table 1: Suggested Testing Timetable

Test s Frequency

Preventive Maintenance

Other Regular Tests

Performance Assurance Test s

Safety Test s

Visual

Electrical

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. Visual Inspection Before each use. Power On Test

ECG/Resp Performance Once every two years, or if you suspect the ECG Out Sync Performance* ECG Sync Pulse Performance* SpO2 Performance NBP Performance Invasive Pressure Performance* Temperature Accuracy* Predictive Temperature Accuracy Check Mainstream CO2 Accuracy Check* Sidestream CO2 Accuracy Check and

Flow Check* Microstream CO2 Performance Test* Nurse Call Relay Performance* Power Loss Alarm Buzzer Performance Visual Inspection After each service event

Protective Earth Once every two years and after repairs Equipment Leakage Current Patient Leakage Current

System Test Once every two years

measurement is incorrect, except

Mainstream CO2 Accuracy Check,

Sidestream CO2 Accuracy Check and Flow

Check and Predictive Temperature

Accuracy Check - required once a year.

where the power supply has been removed

or replaced or the monitor has been

damaged by impact.

* These tests do not apply for MP5T.

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.

Table 2 When to perform tests

3 Testing and Maintenance

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

Preventive Maintenance

Preventive Maintenance* Perform preventive maintenance tests and

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

procedures:

• NBP calibration

• Microstream CO2 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 electrical surge.

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

3 Testing and Maintenance

Service Event

(When performing...

Repairs where the power supply, the mains

socket or an interface board is removed or

Tests Required

...Complete these tests)

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 All other IntelliVue Monitoring System repairs

(except when power supply is removed)

Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test

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.

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Service Event

(When performing...

Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed

Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed

Hardware Upgrades where Short Range Radio (SRR) is installed

Installation of Interfaces or Hardware Upgrades where the power supply or parameter boards need to be removed.

Combining or Exchanging System Components (non-medical equipment

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

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IIT

communication Test

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IntelliVue 802.11

Bedside Adapter Communication Test

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and SRR

communication Test

Perform Visual Inspection, Power On Test, Basic

Performance Tests and all Safety Tests

Perform the System Test for the respective system

components

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 required)

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 of the monitoring system 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 “System Test” on page 57 procedure.

Accessories of the monitoring system 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.

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• The consistent use of a Safety Analyzeras 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 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: IEC60601-1:1988 + A1:1991 + A2:1995 = EN60601-1:1990 +A1:1993 + A2:1995 IEC60601-1-1:2000 For USA, the monitor complies with: UL60601-1 For Canada, CAN/CSA C22.2#601.1-M90

• 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 with IEC/EN 60601-1-1.

• Perform safety tests as described on the following pages.

Safety Test Procedures

Use the test procedures outlined here only for verifying safe installation or service of the product. 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.

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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

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.

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

• Measurement of insulation resistance is not required.

Guideline for Performance of Safety Tests

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, e.g. to the equipotential connector. 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

Equipment Leakage Current Test - Setup Example

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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.

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 (MP2/X2, MP5, M3001A & M1020B #A01, #A02, #A03)

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SpO2 (M1020A)

Invasive Pressure

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M1006B #C01

Temperature

CO2 (MP5, M3014A)

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CO2 (M1016A, M3016A)

4 = all resistors 120 KOhm

Cardiac Output

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BIS

Use Clamp Adapter Cable and M1034-61650 BIS sensor simulator.

VueLink

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4 = 220 Ohm

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IntelliBridge

EEG

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SvO2 (M1021A)

ScVO2 (M1011A)

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tcpO2/tcpCO2

MP5 Predictive Temperature

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MP5 TAAP

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 Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth (PE).

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

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.

For measurement limits, refer to Safety (1) test, Test and Inspection Matrix.

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.

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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 exposed 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.

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.

For measurement limits, refer to Safety (2) test, Test and Inspection Matrix.

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.

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 test measures leakage current of exposed metal parts of the monitor and the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 open (Single Fault Condition).

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.

For measurement limits, refer to Safety (3) test, Test and Inspection Matrix.

Report the highest value (X2).

Test Expected test results

Equipment Leakage Current Test

X2 <= 300μA (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.

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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.

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.

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. This test is applicable for ECG measurement inputs.

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

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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.

For measurement limits and test voltage, refer to test block Safety (4), Test and Inspection Matrix.

Report the highest value. (X1).

Test Expected test results

Applied Part Leakage Current Test (Single Fault Condition - mains on applied part)

NOTE

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

X1 <= 50μA

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 with IEC/EN 60601-1-1.

• Any electrical device such as IT equipment that is connected to the medical electrical equipment must comply with IEC/EN 60601-1-1 and be tested accordingly.

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. 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. These higher limits are acceptable only outside the patient environment. It is essential to reduce equipment leakage currents to values specified in IEC 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. 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. The whole installation, including devices outside of the patient vicinity, must comply with IEC/EN 60601-1-

1. Any non-medical device placed and operated in the patient’s vicinity must be powered via a separating transformer (compliant with IEC/EN 60601-1-1) that ensures mechanical fixing of the power cords and covering of any unused power outlets.

System Installation Requirements

• Ensure that the 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.

• 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.

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• 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 60601-1-

• 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 60601-1-1 to limit increased equipment leakage currents caused by current flow through the signal connections. This only works if the equipment leakage current of the respective medical electrical system parts is not exceeded under normal conditions.

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

• 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.

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Required Protective Measures at System Installation

For any IT equipment (IEC60950) operated in patient vicinity 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 patient vicinity, an enclosure leakage current test is required.

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, 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. 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.

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, 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.

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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. 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 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 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.

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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 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.

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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 the LAN network. 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).

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.

Test Expected test results

Protective Earth Leakage Current of Multiple Socket Outlets

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

Sys1 <= 100μA

Sys2 <= 300μA

Sys3 <= 300μA

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.

Performance Assurance Tests

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

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

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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.

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 When to perform Tests 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, or connect the

M4841A/M4851A via TAAP cable or Short Range Radio to the monitor and connect the patient simulator to the ECG/Resp connector.

Service to

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.

Respiration Performance (not available via TAAP or Short Range Radio)

1 Change the Patient Simulator configuration to:

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

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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 Sync and Marker Output.

• Patient simulator.

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

Output on 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 Switch the defibrillator to simulation mode.

4 Check that the marker pulse is displayed before the T-wave begins.

Test Expected test results

ECG Out Sync Performance Test Marker pulse is displayed before the

ECG Sync Pulse Performance Test

1 Make sure the interface is properly configured. See configuration guide for details

2 Provide a clean ECG signal (from patient or simulator) to the monitor.

3 Connect the cable to the monitor.

4 Marker pulses should show on the screen.

SpO2 Performance Test

T-wave begins

This test checks the performance of the SpO2 measurement.

Tools required: none

1 Connect an adult SpO2 transducer to the SpO2 connector.

2 Measure the SpO

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

The value should be between 95% and 100%.

Test Expected test results

SpO2 Performance Test 95% and 100%

Measurement Validation

The SpO2 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% SaO2 were studied. The population characteristics for those studies were:

• about 50% female and 50% male subjects

• age range: 18 to 45

• skin tone: from light to black

NOTE

A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. 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.

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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

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 0.2% of reading.

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

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• 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, calibrate

the MMS. If not, proceed to the leakage test.

9 To calibrate the MMS, 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 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

EnterPrVal is

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.

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)

Valve Test

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If the difference is greater than 3 mmHg, calibrate the MMS (see steps 9 to 10 in the accuracy test

procedure).

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 = value displayed by monitor

Difference ≤ 3mmHg

Leakage test x2 = leakage test value

x2 < 6 mmHg

Linearity test x3 = value displayed by monitor

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

Temperature Performance Test

This test checks the performance of the temperature measurement.

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

1 Connect the patient simulator to the temperature connector.

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

3 Testing and Maintenance

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:

1 Attach the M2501A CO

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

2 Switch on the patient monitor.

3 Enter the monitor’s Service Mode.

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

3 Testing and Maintenance

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

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:

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.

4 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.

3 Testing and Maintenance

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/

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 monitor completes the current operation, then restart the service procedure.

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 MMS Extension. The Microstream CO2 performance test is required once per year and when the instrument is repaired or when parts are replaced.

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

extension pump draws. It should be 50

min

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

• Gas calibration equipment:

3 Testing and Maintenance

• 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

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.

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

• Leakage check

• Barometric pressure check and calibration, if required.

•Pump check

• Flow check and calibration, if required

•Noise check

• CO2 Cal check and calibration, if required

• CO2 Cal verification using 2nd cal gas

Perform all checks in the same session.

Leakage Check

The leakage check consists of checking the tubing between:

• the pump outlet and the mCO

• the pump inlet and FilterLine inlet.

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

Part 1 1 Go into service mode and select Setup CO2 menu.

2 Connect a FilterLine to the Microstream CO

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

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

5 Block the mCO

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

outlet and

input to start the pump running.

pressure should be approximately 20 mmHg lower than ambient pressure.

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.

outlet.

mCO

3 Testing and Maintenance

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

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 Filterline connected to the M3015A inlet or the MP5 mCO

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

pump inlet.

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

at the pump inlet and the M3015A or MP5 mCO replacing the FilterLine and repeating the leakage check. If the situation remains, there is a leakage

in the tubing and the M3015A or the mCO

gas outlet.

Assembly of the MP5 respectively.

inlet..

gas inlet. If the connections are good, try

assembly of the MP5 must be exchanged.

Barometric Pressure Check and Calibration

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

1 Go into service mode and select Setup CO

2 Connect a FilterLine to the Microstream CO

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.

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.

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

menu.

input. This activates the pump in the M3015A MMS

pressure reading (ambient/cell) xxx/

Pump Check

1 Connect the flowmeter inlet to the mCO

2 Connect the FilterLine to the mCO

inlet.

gas outlet.

Block the inlet of the FilterLine using your fingertip and observe the cell pressure on the monitor

display. The cell pressure (x4) should be more than 120 mmHg below the ambient pressure shown. If the pressure difference is less than 120 mmHg, the pump is not strong enough and you should replace it, irrespective of the Pump OpTime.

Flow Rate Check and Calibration

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

3 Testing and Maintenance

Noise Check

1 Connect the flowmeter to the CO

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

(x5). It should be 50 ml/min ± 7.5 ml/min. If the value is within tolerance, proceed to the CO

FilterLine.

Gas calibration check. If the value is not within tolerance, calibrate as follows.

3 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.

4 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.

5 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

1 With the monitor in service mode, select Setup CO

2 Disconnect the flowmeter and connect the 5% calibration gas and flow regulator in its place.

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.

menu.

value on the display (this indicates the level

CO2 Gas Measurement Calibration Check

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

1 Check that the 5% calibration gas and flow regulator are connected.

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

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 in this procedure onwards.

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

gas measurement as follows:

gas to flow into the extension. Allow the

3 Testing and Maintenance

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

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.

9 If not already connected, connect the 5% calibration gas.

10 Select Cal. CO

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

12 Open the valve on the calibration gas to allow CO

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

13 The extension calibrates and prompts when calibration is successful.

Calibration Verification

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

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

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

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

value to stabilize.

gas to flow into the extension. Allow the

gas to flow into the extension. Allow the value

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

If one or both values are not within tolerances, you must exchange the M3015A 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)

Barometric Pressure Check

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

(x3<12 mmHg)

Pump Check x4 = difference in pressure between cell pressure and

ambient pressure displayed on the monitor during occlusion (x4 >120 mmHg)

Test Expected Test Results

Flow Check x5 = difference between measured value and 50.0 ml/min

Noise Check x6 = noise index displayed on monitor (x6<3.0) CO

Gas Calibration

Check

CO2 Cal Verification x8 = difference between measured CO2 value and

Reset Time Counters

NOTE

This procedure only applies to M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx

3 Testing and Maintenance

(x5<7.5 ml/min)

x7 = difference between measured CO2 value and

calculated value, based on 5% CO

cal. gas. (x7 < 2.6

mmHg)

calculated value, based on 10% CO

cal. gas.

(x8 < ± {0.07 x value calculated})

You must check the time counters on the Microstream CO

extension before calibrating the

instrument. As well, when parts are replaced, the appropriate counters must be reset to zero.

The counters for CO2 pump, IR Src and Last Cal are displayed in the status line. The values are updated when entering the

Setup CO2 menu.

Observe the following guidelines:

• When calibrating the CO

Reset PumpOpTime and Reset IRSourceTime selections to make sure that they are within

extension, if no parts have been replaced, check the displayed values of

suggested guidelines for use (15, 000 hours of continuous use). If the counter time is greater than 15, 000 hours, replace the appropriate part. See Repair and Disassembly for details.

• When calibrating the CO the

Reset PumpOpTime and Reset IRSourceTime selections. See Repair and Disassembly for details.

Resetting the PumpOpTime generates the INOP: “CO

extension, if parts have been replaced, reset the appropriate values using

OCCLUSION”. To clear this INOP you

must perform a flow check and store the flow in service mode (select

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:

Store Flow).

• Standard Operation—Relay open.

• Alarm Condition—Relay closed.

Tools required: Ohmmeter.

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

3 Testing and Maintenance

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.

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

Test Expected test results

Nurse Call Relay Performance Test Alarm Condition—Relay open

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.

3 Testing and Maintenance

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

Beep for one minute

Test

IntelliVue 802.11 Bedside Adapter Communication Test (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

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

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 WPA(PSK) and enter the WPA password (string between 8 and 63

characters).

Conn.Status field in the service window shows Authenticatd

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

RSSI value wil 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

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

the 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.

6 Perform the Wireless Switch test blocks as described in the Philips IntelliVue 802.11 a/g

Infrastructure Installation and Configuration Guide.

Test Expected test results

IntelliVue 802.11 Bedside Adapter

RSSI value above 30

Performance Test

3 Testing and Maintenance

IIT Communication Test (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

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

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

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

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.

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.

2 Assign a telemetry transceiver 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 close to the monitor.

b. The telemetry transceiver status is displayed on the monitor in the measurement selection

window.

c. Waves or numerics from the telemetry transceiver are displayed on the monitor. There a re no

dropouts or gaps in waves or numeric transmission.

d. The battery status of the telemetry transceiver is displayed in the measurement selection

window.

e. The Signal Quality Indicator shows at least

4 Check that the data from the telemetry transceiver 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 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 and inform the customer about

this coverage area.

Reporting of Test Results

Philips recommends all test results are documented in accordance with local laws. Authorized Philips personnel report test result back to Philips to add to the product development database. 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.

3 Testing and Maintenance

The following table lists what to record after completing the tests in this chapter. Record the results in the empty column in Table 16.

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.

3 Testing and Maintenance

Carrying Out and Reporting Tests

Test Report

Testing Organization:

Name of testing person:

Responsible Organization:

Device Under Test: ID-Number

Product Number: Serial No.:

Accessories:

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

Functional Test (parameters tested):

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

Test and Inspection Matrix

3 Testing and Maintenance

Test Test or Inspection

to be Performed

Visual Inspection

Power On Power on the unit.

Noninvasive Blood Pressure Performance Tests

Temperature Performance Test

All other performance tests

Safety (1) Perform Safety Test

Safety (2) Perform Safety Test

Safety (3) Perform Safety Test

Perform Visual Inspection

Does the self-test complete successfully

Perform the Accuracy Test

Performance Leakage Test

Performance Linearity Test

Performance Valve Test

Perform the Temperature Performance Test

Perform the remaining parameter performance tests, if applicable

(1): Protective Earth Resistance

(2): Equipment Leakage Current Normal Condition.

(3): Equipment Leakage Current Single Fault Condition (Open Earth)

Expected Test Results Record the Results (mandatory for

Philips Personnel only)

What to record Actual Results

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

See expected results in test procedures

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

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

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

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

P: P or

P: F

S(1):P/X1 or

S(1):F/X1

S(2): P/X1 or

S(2): F/X1

S(3): P/X2 or

S(3): F/X2

3 Testing and Maintenance

Test Test or Inspection

Expected Test Results Record the Results (mandatory for

to be Performed

Safety (4) Perform Safety Test

(4): Patient Leakage

Maximum leakage current (X1):

<=50 μA Current - Single Fault Condition, mains on applied part.

System (Sys 1-2)

System (Sys 3)

Perform the system test according to subclause 19.201 of IEC/EN 60601-11, if applicable, after forming a system

Equipment Leakage Current:

Sys1 <= 100 μA (Normal

Condition)

Sys2 <= 300μA (Single Fault

Condition

Protective Earth Leakage

Current if medical electrical

system components are

connected to the same Multiple

Portable Socket Outlet:

Sys3 <= 300 μA

Key: P = Pass, F = Fail, X or Sys = test value to be recorded

Philips Personnel only)

What to record Actual Results

S(4): P/X1 or

S(4): F/X1

Sys: PSys1/PSys2

Sys: FSys1/Fsys2

Sys: PSys3

Sys: FSys3

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.

Yes No

Notes:

Next Recurrent Test:

Name:____________________________________________________

Date/Signature:_____________________________________________

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.

3 Testing and Maintenance

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

4 Select Touch Calibration

3 Testing and Maintenance

Figure 7 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 select

Calibration to Default

calibration menu again via the touchscreen.

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

and it will create a rough calibration which will allow you to access the

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.

Reset Touch

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 Patient Monitors 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.

About the Battery

The rechargeable Lithium-Ion battery used in the monitor is regarded as a Smart battery because it has built-in circuitry. (This circuitry communicates battery-status information to the Monitor.)

To get the most out of the batteries, observe the following guidelines:

• Condition the battery only upon maintenance request prompt on display.

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

• Capabilities of integrated battery charger: 12.6V, 2.5 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 or more during monitor operation, depending on the monitor configuration.

NOTE

In certain situations, where many measurements are in use plus the recorder, the load on the monitor may be so high that the batteries will not charge. In this case you must use the M8043A Smart Battery Charger to charge the battery.

3 Testing and Maintenance

• Battery Disposal—The battery should be disposed of in an environmentally-responsible manner. Consult the hospital administrator or your local Philips representative for local arrangements.

Do not dispose of the battery in normal waste containers.

• Battery Storage — Batteries should not remain inside the monitor if they are not used for a longer period of time. Batteries should be max. 50% charged for storage.

NOTE

The battery will discharge over time if it is stored inside the monitor without AC power connection. The reported values “remaining capacity” and “runtime” will become less accurate when the battery is stored inside the monitor without AC Power connection for a longer period of time (i.e. several weeks).

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 M8043A Smart battery charger.

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

• LED on the front panel of the Monitor.

• 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

Yell ow

Red, flashing

Red, flashes intermittently

battery full (≥90%)

battery charging (battery power < 90%)

battery or charger malfunction1,2

If the monitor is running on battery power, this means

≤ 10 minutes power remaining

battery or charger malfunction1,2

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

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:

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

3 Testing and Maintenance

Battery requires maintenance

Battery is empty

Battery not charging as the temperature is above or below the specified range

Charging stopped to protect the battery

Battery Malfunction Symbols

Incompatible Battery

Battery Malfunction

Battery temperature too high

Battery has no power left

Explanations of Battery Status and Malfunction Symbols:

Battery requires maintenance: The battery requires conditioning. Refer to “Conditioning Batteries” for details.

Battery is empty: The capacity of the battery is ≤10 min. Recharge the battery as soon as possible.

3 Testing and Maintenance

Temperature outside specified range: The charging of the battery is stopped if the temperature is below 15°C or above 50°C in order to protect the battery. Charging is resumed as soon as the temperature is within this range.

Incompatible Battery: The inserted battery is checked for certain battery internal parameters. If these are not correct, the incompatible battery symbol is displayed. Please use only M4605A batteries with the MP5 monitor. Note that the incompatible battery symbol may also appear if there is a communication problem between the battery and the battery board.

Battery Malfunction:Communication between the battery and the battery board could not be established within about 4 minutes or battery internal data indicates malfunction. Please see the “Troubleshooting” section for remedies.

Battery Temperature too high: This symbol is displayed if the battery temperature goes above 65°C. In addition the INOP message CHECK BATT TEMP is displayed. If the battery temperature increases further above 70°C the batteries will switch off for safety reasons. Allow the battery to cool down to avoid the monitor switching off.

Battery has no power left: If the monitor is not running on AC power: battery will switch off power delivery at any moment - in this case recharge the battery immediately - or, if the monitor is running on AC power, the battery is in deep discharge and requires pre-charging to restore communication. To avoid this condition charge batteries to 50% for storage. Note that the battery malfunction INOP will eventually be issued if the pre-charging does not restore battery communication within about 4 minutes.

Battery Status Window

♦ To access the Battery Status window and its associated pop-up keys, select the battery status

information on the Screen, or select

Capacity, Remaining tells you how much power is left in the battery.

Capacity, Full Charge tells you how much power the battery can hold when fully charged.

Time To Empty tells you approximately how long you can continue to use the monitor with this

battery. Note that this time fluctuates depending on the system load (how many measurements and recordings you carry out), the age of the battery, and the remaining capacity of the battery. The time indication appears after AC has been unplugged for about 30 seconds (after finishing calculation of the Time to Empty)

Time To Full is shown in place of Time To Empty if the monitor is connected to AC power, and tells

you how much time is left until the battery is charged to 90%. Please allow indication to stabilize for 3 to 5 minutes after beginning the charging cycle. If the battery is charged over 90% is displayed until they are charged to 100%. Then

Main Setup -> Battery.

Battery Full (>90%)

Batt Fully Charged is displayed.

Viewing Battery Details

♦ To view detailed information for the battery, select the pop-up key Batt.

Documenting Battery Status

To print all battery information in the Battery Status window,

1 Select the battery status information on the Screen or select Main Setup -> Battery to open the

Battery Status window

2 Select the Record Status pop-up key to print the information on a recorder

Select the

Print Status pop-up key to print the information on a connected printer.

3 Testing and Maintenance

Conditioning a Battery

What is Battery Conditioning?

Battery conditioning recalibrates the battery to ensure that it has accurate information on the actual battery capacity.

Why is Battery Conditioning Necessary?

The capacity of a battery decreases gradually over the lifetime of a battery. Each time a battery is charged its capacity decreases slightly. Therefore, the operating time of a monitor running on batteries also decreases with each charge cycle.

Battery conditioning ensures that the value stored in the battery for its full capacity takes account of this decrease, so that the remaining battery charge can be calculated accurately, and the low battery warning given at the right time.

When Should Battery Conditioning be Performed?

Battery conditioning should be performed when indicated by the Battery Status.

NOTE

When the battery status signals a conditioning request, the displayed Time to Full or Time to Empty may not be reliable.

What Causes the Conditioning Message on the Monitor?

In addition to the value for the full capacity, the battery also stores a value for the Max Error. The Max Error tracks the maximum possible deviation of the estimated charge of a battery from the actual charge.

3 Testing and Maintenance

If a battery is charged or discharged partially, or if it is charged while the monitor is being used, the accuracy of the “reference points” for the fully discharged and fully charged states decreases, causing an increase in the value for the Max Error (see diagram, below).

When the Max Error rises over a certain limit, a message is displayed prompting the user to condition the battery, as described in “Conditioning Batteries” on page 96.

You can reset the value for the Max Error before the battery needs conditioning, by performing the steps described in”Conditioning Batteries”. The minimum value of the Max Error after conditioning is 2%.

Conditioning Batteries

Battery conditioning can either be performed in the monitor or with an external battery charger. Philips recommends using the M8043A Smart Battery Charger to condition batteries.

Battery Conditioning in the Monitor

CAUTION

Do not use a monitor being used to monitor patients to condition batteries. The monitor switches off automatically when the battery is empty.

You should condition a battery when its “battery requires maintenance” symbol shows on the Screen. If conditioning is not performed immediately the monitor will still function according to specifications. However, the displayed time to empty and time to full will show increasing inaccuracy. Do not interrupt the charge or discharge cycle during conditioning. To condition a battery,

1 Insert the battery into a monitor connected to mains power.

Charge the battery until it is completely full. Switch the monitor off to decrease the charging time

When the battery LED turns green i.e. the battery is >90% charged, switch on the monitor and open the

3 Disconnect the monitor from AC power, and let the monitor run until the battery is empty and the

monitor switches itself off.

4 Reconnect the monitor to AC power and charge the battery until it is full for use or charge to 50%

for storage.

Battery Status window. Check that the Battery fully charged message is displayed.

Battery Conditioning with an External Charger

You can use the M8043A Smart Battery Charger for external battery conditioning. For details please see the IfU for the Smart Battery Charger. Use only the M8043A Smart battery charger.

After Installation, Testing or Repair

Before handing the patient monitor over to the end-user, make sure it is configured appropriately and that it is in monitoring mode. Ensure that the user receives the current revision of the monitor documentation.

3 Testing and Maintenance

4Troubleshooting

Introduction

This section explains how to troubleshoot the monitor if problems arise. Links to tables that list possible monitor difficulties are supplied, along with probable causes, and recommended actions to correct the difficulty.

How To Use This Section

Use this section in conjunction with the sections Testing and Maintenance and Parts. To remove and replace a part you suspect is defective, follow the instructions in the section Repair and Disassembly. The Theory of Operation section offers information on how the monitor functions.

Who Should Perform Repairs

Only qualified service personnel (biomedical engineers or technicians) should open the monitor housing, remove and replace components, or make adjustments. If your medical facility does not have qualified service personnel, contact Philips’ Response Center or your local Philips representative.

WARNING

High Voltage - Voltages dangerous to life are present in the instrument when it is connected to the mains power supply. Do not perform any disassembly procedures (other than server removal) with power applied to the instrument. Failure to adhere to this warning could cause serious injury or death.

Replacement Level Supported

The replacement level supported for this product is to the printed circuit board (PCB) and major subassembly level. Once you isolate a suspected PCB, follow the procedures in the Repair and Disassembly section, to replace the PCB with a known good PCB. Check to see if the symptom disappears and that the monitor passes all performance tests. If the symptom persists, swap back the replacement PCB with the suspected malfunctioning PCB (the original PCB that was installed when you started troubleshooting) and continue troubleshooting as directed in this section.

4 Troubleshooting

Software Revision Check

Some troubleshooting tasks may require that you identify the Software Revision of your monitor. You can find the software revision along with other information, such as the system serial number, in the monitor revision screen.To access the monitor revision screen:

1 Enter the Main Setup menu and select Revision

2 Select Product

3 Select Software Revision

4 Select the pop-up key for the device you want to check (e.g. M8105A)

NOTE

The part numbers listed in the monitor revision screen do not necessarily reflect the part numbers required for ordering parts. Please refer to the Parts section for the ordering numbers.

NOTE

The system serial number can also be found on the back of the monitor.

Compatibilty of MP5 in Companion Mode with IntelliVue Patient Monitors

The following table shows the compatibility between IntelliVue Patient Monitor and MP5 software revisions when MP5 is used in Companion Mode as an MMS.

Host Monitor Software

F. 0 Ye s Ye s G.0 Yes Yes

MP5 Software

F. 0 G.0

Compatibility with Information Center

The following tables show the compatibility between the MP2/X2/MP5 and the Information Center software revisions. The first table shows the compatibility if MP2/X2/MP5 are used as pure monitor or measurement module. The second table shows the compatibility if the MP2/X2/MP5 are used in companion mode i.e. as monitor and measurement module.

MP5/ MP2/X2 Software

E.0 No No No Yes Yes Yes Yes Yes Yes F. 0 N o No No No Yes Yes Ye s Yes Yes G.0 No No No No Yes Yes Yes Yes Yes

Information Center Software

D.01 E.0 E.01 F. 0 G.0 H.0 J.0 K.0 L.0

100

Philips Intellivue MP5 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Service Manual

IntelliVue Patient Monitors

MP5/MP5T

Rel. G.0

Patient Monitoring

*4535 641 80621*

1 Introduction 7

2 Theory of Operation 9

3 Testing and Maintenance 25

4 Troubleshooting 99

5 Repair and Disassembly 133

6 Parts 183

7 Installation Instructions 199

8 Site Preparation 225

9 Gas Analyzers (not for MP5T) 235

10 MP5 Product Structure 237

11 Default Settings Appendix 245

Index 255

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

Who Should Use This Guide

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

1Introduction

How to Use This Guide

Abbreviations

Abbreviations used throughout this guide are:

Name Abbreviation

IntelliVue MP5/MP5T 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

• 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.

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:

2Theory of Operation

Monitor Theory of Operation

The IntelliVue MP5/MP5T Patient Monitor:

• displays real-time data

• alarms in the case of patient or equipment problems

• offers limited data storage and retrieval (trending)

• interfaces to the Philips Clinical Network and other equipment (not MP5T)

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

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

Functionality (including optional features) MP5 MP5T

SpO2 yes yes

Predictive Temperature yes yes

Temperature yes no

Invasive Pressure yes no

Carbon Dioxide yes no

Microstream CO

Direct Telemetry Connection yes yes

ECG Output signal yes no

LAN networking capability yes no

WLAN networking capability yes no

IntelliVue Instrument Telemetry networking capability yes no

Short Range Radio capability yes yes

NOTE

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

Severe Sepsis Screening yes no

OxyCRG high resolution trend yes no

4535 641 80621