Philips IntelliVue MP User manual

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IntelliVue MP2/X2

Service Guide

IntelliVue Patient Monitor

MP2/X2

Patient Monitoring

Part Number M3002-9301B 4535 641 12541

*M3002-9301B*

Contents

1 Introduction 9

Who Should Use This Guide 9 How to Use This Guide 9 Responsibility of the Manufacturer 10 Passwords 10 Warnings and Cautions 11

2 Theory of Operation 13

Monitor Theory of Operation 13

System Boundaries 14 Hardware Building Blocks 15 Data Flow 19 How does the Support Tool Work with the Monitor 22 Monitor Software Block Diagram 22 Block Diagram Legend 23

3 Testing and Maintenance 27

Introduction 27 Terminology and Definitions 28 Recommended Frequency 29 When to Perform Tests 30 Testing Sequence 34 Visual Inspection 35

Before Each Use 35 After Each Service, Maintenance or Repair Event 35 Power On Test 35

Safety Tests 36

Warnings, Cautions, and Safety Precautions 37 Safety Test Procedures 38

System Test 62

What is a Medical Electrical System? 62 General Requirements for a System 62 System Example 63 System Installation Requirements 64 Required Protective Measures at System Installation 65 System Test Procedure 75

Preventive Maintenance Procedures 76

Noninvasive Blood Pressure Measurement Calibration 76

Performance Assurance Tests 76

Basic Performance Assurance Test 76

Full Performance Assurance Test 77 ECG/Resp Performance Test 77 ECG Sync Performance Test 78 SpO2 Performance Test 78 NBP PerformanceTest 79 Invasive Pressure Performance Test 81 Temperature Performance Test 82 M3014A Capnography Extension Performance Tests 82 Microstream CO2 Performance Test 85 Cardiac Output Performance Test 90 Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed) 92 IntelliVue 802.11 Bedside Adapter Communication Test 92 IIT Communication Test 93 Short Range Radio (SRR) Performance Test 94

Reporting of Test Results 95

Carrying Out and Reporting Tests 95 Evaluation of Test Results 97

Other Regular Tests 98 Locking/Unlocking Touch Operation 98 Battery Handling, Maintenance and Good Practices 98

About the Battery 98 Checking the Battery Status 99 Battery Status on the Main Screen 100 Battery Status Window 101 Checking Battery Charge 103 Replacing a Battery 103 Optimizing Battery Performance 104 Battery Safety Information 108

After Installation, Testing or Repair 108

4 Troubleshooting 109

Introduction 109 How To Use This Section 109 Who Should Perform Repairs 109 Replacement Level Supported 110 Software Revision Check 110 Software Compatibility Matrix 110

Compatibilty with MMS 111 Compatibility with Information Center 111

Obtaining Replacement Parts 111 Troubleshooting Guide 112

Checks for Obvious Problems 112 Checks Before Opening the Instrument 112 Troubleshooting Tables 114

Status Log 130 List of Error Codes 131 Troubleshooting with the Support Tool 131 Troubleshooting the Individual Measurements or Applications 131

5 Repair and Disassembly 133

Who Should Perform Repairs 133 Tools required 133 Removing the Battery 134 Removing the Handle 134 Removing the Side Cover 135 Removing the Display/Exchangi ng the SR R B oar d 136

Reassembly of the Display 138

Removing the NBP Pump Assembly 138

Reassembling the NBP pump chassis 140

Exchanging the NBP Pump 142 Exchanging the NBP Airguide / IIT or WLAN Assembly 145

Reassembly Procedure 147

Exchanging the Loudspeaker 150

Reassembly Procedure 151

Removing the Power Board 152

Reassembly Procedure 154

Removing the ECG Sync Pulse Out Connector 155 Removing the Main Board 157 Removing the Rear Housing 158 Removing the Measurements 160 Exchanging the Main Housing 161 Exchanging the Silicon Pads 162 MMS Extensions - Exchanging the Top Cover, MSL Flex Cable and the Dual Link Bar 165

Exchange Procedures 166

Disassembly Procedures for the M3015A MMS Extension (HW Rev. A) 177

Removing the Front Cover 177 Refit Procedures for the MMS Extension 181

Smart Battery Charger LG1480 (M8043A) 183

Cleaning the Air Filter Mats 183 Replacing the Fan 183

6 Parts 187

Exchange and Replacement Parts 189 MMS Extension Parts (M3012A, M3014A, M3015A and M3016A) 192

MMS Extension Part Numbers - Release Mechanisms 192 MMS Extension Part Numbers - Top Cover, Flex Cable and Link Bar 193 MMS Extension Part Numbers - Front Bezels 193 Exchange Parts List 195

Smart Battery Charger Part Numbers

197

7 Installation Instructions 199

Out-Of-Hospital Transport - Standards C om pli ance 199 Electromagnetic Interference (SRR) 201 Installation Checklist 201 Unpacking and Checking the Shipment 201

Initial Inspection 202 Claims for Damage 202 Repacking 202

Mounting the Monitor 203

Mounting the Monitor using the Anti-slip Pad 203 Mounting the Monitor using the MMS Mount and Mounting Clamp 205

Connecting the Monitor to AC Mains 209

Host Monitor as Power Source 209 External Power Supply M8023A(Standard with MP2, Optional with X2) 210

Checking Out the Monitor 211 Configuration Tasks 212

Checking Country-Specific Default Settings 212 Setting Altitude, Line Frequency, ECG Cable Colors and Height & Weight Units 213 Configuring the Equipment Label 213 Configuring IP Address, Subnet Mask and Default Gateway 214 Configuration Settings for CSCN Routed Bedside Monitors (RBM) 214 Configuring Routed Bedside Monitors Support 215

Setting the Date and Time 215 Handing Over the Monitor 216 Philips Clinical Network (Wired) 216 Philips IntelliVue Information Center 216 IntelliVue Instrument Telemetry (IIT) 217 Short Range Radio 218

Configuring SRR Channels 218

ECG Sync Pulse 221 MSL Cable Termination 222

8 Site Preparation 225

Introduction 225

Site Planning 225 Roles & Responsibilities 226

Monitor Site Requirements 228

Space Requirements 228 Environmental Requirements 228 Electrical and Safety Requirements (Customer or Philips) 229 Connecting Non-Medical Devices 230

Philips Medical LAN 230

9 MP2/X2 Product Structure 231

Upgrades 238

10 Default Settings Appendix 241

Country-Specific Default Settings 241

11 Index 251

1Introduction

This Service Guide contains technical details for the IntelliVue MP2 Patient Monitor and the IntelliVue X2.

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

Who Should Use This Guide

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

How to Use This Guide

This guide is divided into eight sections. Navigate through the tab le of conte nts 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.

1 Introduction Responsibility of the Manufacturer

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 1 Introduction

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 effecti ve 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.

1 Introduction Warnings and Cautions

12 13

2Theory of Operation

Monitor Theory of Operation

The IntelliVue MP2/X2 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

NOTE

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

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

2 Theory of Operation Monitor Theory of Operation

System Boundaries

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

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

Monitor Theory of Operation 2 Theory of Operation

Hardware Building Blocks

The following hardware building blocks make up the monitoring system:

IntelliVue MP2

MP2/X2 Hardware Building Blocks

The MP2 monitor:

- integrates the display and processing unit into a single package

- uses a 3.5” color TFT display

- uses the Touchscreen as input device

- integrates the measurement block with optional parameter sets

- has an internal battery

- standalone patient monitor

2 Theory of Operation Monitor Theory of Operation

IntelliVue X2

The IntelliVue X2:

- integrates the display and processing unit into a single package

- uses a 3.5” color TFT display

- uses the Touchscreen as input device

- integrates the measurement block with optional parameter sets

- has an internal battery

- can be used as a Multi-Measurement Module or as a standalone patient monitor

Optional Hardware

- 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.

- Integrated Short Range Radio (SRR)

Power Distribution

Power Distribution Architecture

Monitor Theory of Operation 2 Theory of Operation

The DC/DC converter transforms the DC power (36-60 V DC range) coming from the MSL plug into a 16 V DC source and isolates the monitoring system from the DC MSL.

The 16V DC is distributed via the Power Board to the battery charging circuit and to the main board.

The power is used to charge the battery and supply the monitoring system. As soon as the DC power source is disconnected, the battery starts and keeps the system powered (battery mode).

The main board contains power supply circuits, which convert the 16 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 16 V DC system power or by the battery power and converted to 3.6 V DC.

The CPU board has an MPC852 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. The main board contains additional video hardware.

The CPU provides a LAN interface to connect to the Philips Clinical Network (Ethernet).

System Interfaces

The LAN interface on the Measurement Link (MSL) is used as the network interface.

2 Theory of Operation Monitor Theory of Operation

Compatible Devices

NOTE

M3012A, M3014A, M3015A, M3016A MMS Extensions

The MMS Extensions are not supported if the IntelliVue MP2/X2 is powered from the internal battery. Although they can still be attached, they will not function in this case.

Monitor Theory of Operation 2 Theory of Operation

Data Flow

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

Display

and User

Interface

Data

Acquisition

Data

Provider Service

Applications

Data Flow

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

- External measurement devices

- Server systems on the Philips Clinical Network

Persistent

Data

Storage

Data

Output

The integrated measurements convert patient signals to digital data and apply measurement algorithms to analyze the signals.

Data can be also acquired from devices connected to the monitor. Software modules dedicated to such specific devices convert the data received from an external device to the format used internally.

To enable networked applications, data can be acquired from server systems attached to the Philips Clinical Network, for example a Philips Information Center

2 Theory of Operation Monitor Theory of Operation

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.

Monitor Theory of Operation 2 Theory of Operation

Internal LAN (Measurement Link)

The MP2/X2 communicates using an IEEE802.3 Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the components, for exam ple:

- 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 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 X2 to the host monitor (for example measurement signal data) and the data flow from the host monitor to an X2 (for example to feed data to a recorder module).

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.

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.

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

2 Theory of Operation Monitor Theory of Operation

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 componen ts in the system over the network.

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

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

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

Monitor Software Block Diagram

The figure below 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.

Functional Block Diagram

Monitor Theory of Operation 2 Theory of Operation

Block Diagram Legend

Functional Block Description

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

System Services The System Services provide generic common system 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

Applications Reports The Reports Service retrieves current and stored physiological 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.

2 Theory of Operation Monitor 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.

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 MDSE The MDSE (Medical Data Service Element) Interface 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. Printer The Printer Interface Manager provides a high level interface 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.

Monitor Theory of Operation 2 Theory of Operation

Functional Block Description

Display & Operator Interface

The Display and Operator Interface Manager performs the following tasks:

- 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)

Interfaces 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. Sync Out (ECG) A pulse signal is provided on the Sync Out connector to allow synchronisation

with other medical devices. IIT The built-in IIT module allows operation of the MP2/X2 monitors within

IntelliVue Instrument Telemetry Infrastructure. WLAN The built-in WLAN interface allows wireless operation of the X2/MP2 monitors

with the IntelliVue 802.11 Bedside Adapter SRR The built-in SRR interface allows wireless communication of the MP2/X2

monitors with an IntelliVue Instrument Telemetry Transceiver. MSL 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 and the MMS Extensions. For testing of the host monitor and the Flexible Module Rack (FMS), see the Service Guide of the host 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.

Testing of the MP2/X2 may be performed either on the MP2/X2 (with external power supply) directly or (for the X2) on the host monitor.

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.

3 Testing and Maintenance Terminology and Definitions

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.

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

Recommended Frequency 3 Testing and Maintenance

Recommended Frequency

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

Tests Frequency

Preventive Maintenance*

Table 1: Suggested Testing Timetable

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.

Other Regular Tests

Performance Assurance Tests

Safety Tests

Visual

Electrical

Visual Inspection

Before each use.

Power On Test ECG/Resp Performance

ECG Sync Pulse Performance SpO2 Performance NBP Performance

Once every two years, or if you suspect the measurement is incorrect, except Mainstream CO2 Accuracy Check, Sidestream CO2 Accuracy Check and Flow Check - required once a year.

Invasive Pressure Performance Temperature Accuracy M3014A Capnography Extension

Performance Tests Microstream CO2 Performance Test C.O. Performance Test Visual Inspection After each service event.

Protective Earth Equipment Leakage Current Patient Leakage Current

Once every two years and after repairs where the power supply has been removed or replaced or the monitor has been damaged by impact.

System Test Once every two years

*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the CO2 pump/CO

scrubber replacement procedure. This is required every three years or after 15000

operating hours.

3 Testing and Maintenance When to Perform Tests

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 itself and its host monitor.

When to perform tests

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 monitor with IntelliVue Instrument Telemetry (IIT)

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

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On and System Tests

Perform Visual Inspection, Power On and IIT communication test

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

Perform Visual Inspection, Power On and SRR communication test

Preventive Maintenance*

Other Regular Tests and Tasks

Visual Inspection

Perform preventive maintenance tests and procedures:

- NBP calibration

- Microstream CO2 calibration

Perform Visual Inspection test block

When to Perform Tests 3 Testing and Maintenance

Service Event

(When performing...

Power On Test

Repairs

Repairs where the monitor has been damaged

by impact, liquid ingression, fire, short circuit or electrical surge.

Repairs where the MSL power board is removed or replaced

Repairs where the main board has been replaced.

Tests Required

...Complete these tests)

Perform Power On test block

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

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

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

Repairs of IntelliVue Instrument Telemetry (IIT) Module

Repairs of IntelliVue 802.11 Bedside Adapter

Repairs of Short Range Radio (SRR) Interface

Repairs where the rear housing has been removed or replaced.

Repairs where the NBP pump has been 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.

Perform Visual Inspection, Power On Test Block and IIT communication test

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

Perform Visual Inspection, Power On and SRR Communication Test

Perform Visual Inspection, Power On, all Safety Tests and Basic Performance Assurance Test.

Perform Visual Inspection, Power On, all Safety Tests, Basic Performance Assurance Test and NBP Performance Test and Calibration

Repairs of the M3015A MMS Extension Perform Visual Inspection, Power On, all

Safety Tests, Basic Performance Assurance Test

3 Testing and Maintenance When to Perform Tests

Service Event

(When performing...

All other IntelliVue Monitoring System repairs (except when MSL power board is

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On Test and Basic Performance Assurance Test

removed) Performance Assurance

Basic Performance Assurance Perform basic performance assurance tests for

the respective monitoring system component.

Full Performance Assurance Perform all accuracy and performance test

procedures listed in the following sections. If a particular measurement is in question, perform the measurement performance test only.

Upgrades

Software Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless otherwise specified in the Upgrade Installation Notes shipped with the upgrade.

Hardware Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless otherwise specified in the Upgrade Installation Notes shipped with the upgrade.

Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed

Perform Visual Inspection, Power On Test, Basic Performance Assurance Test and IIT communication Test

Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed

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

Hardware Upgrades where Short Range Radio (SRR) is installed

Perform Visual Inspection, Power On Test, Basic Performance Assurance Test and SRR communication Test

Installation of Interfaces or Hardware Upgrades where the power supply or

Perform Visual Inspection, Power On Test, Basic Performance Tests and all Safety Tests

parameter boards need to be removed.

Combining or Exchanging System Components

Perform the System Test for the respective system components

*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the pump and scrubber replacement procedures.

When to Perform Tests 3 Testing and Maintenance

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.

3 Testing and Maintenance Testing Sequence

Testing Sequence

Summary of the recommended sequence of testing:

Start

Select the test

Visual Inspection

Safety Tests

Performance Tests

Reporting of Results

Evaluation of Results

See When to Perform Tests

See Visual Test (see " page

35).

Before Each Use" on

See Safety Test Procedures (on page

38).

See Performance Assurance Tests (on page

76).

See Reporting of Test Results (on page

95)

See Evaluation of Test Results (on page

97)

NOTE

Check and prepare for normal use

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

Visual Inspection 3 Testing and Maintenance

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 external ly .

- 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

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

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.

and MMS Extensions.

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

3 Testing and Maintenance Safety Tests

Safety Tests

The following safety test needs to be performed on the monitoring system:

- applied part leakage current

- 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

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.

61) procedure.

Electrical safety tests for MP2/X2 can be performed either on the individual device (MP2 or X2) connected to the external power supply or on a connected host monitor (e.g. MP20-90). Note that if the electrical safety tests are performed with a host monitor the protective earth resistance and equipment leakage current come mainly from the host monitor. The earthing of MP2/X2 is for functional purposes and does not provide protection against electric shock. The protection against electric shock in this device is provided by double and/or reinforced insulation. The protective earth resistance and equipment leakage current measurements for MP2/X2 are optional.

Safety Tests 3 Testing and Maintenance

Warnings, Cautions, and Safety Precautions

- These tests are well established procedures of detecting abnormalities that, if undetected,

could result in danger to either the patient or the operator.

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

- Disconnect the device under test from mains before performing safety tests. If this is not

possible, ensure that the performance of these tests does not result in danger to the safety analyzer operator, patients or other individuals.

- Test equipment (for example, a Safety Analyzer) is required to perform the safety tests.

Please refer to Annex C of IEC/EN 62353 for exact requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents. Refer to the documentation that accompanies the test equipment. Only certified technicians should perform safety testing.

- The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is

emphasized as a mandatory step to maintain user and patient safety. You can also use the Safety 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.

3 Testing and Maintenance Safety Tests

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, tog ether with other data.

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

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

CAUTION

Supply mains

Protective earth

L, N Supply mains terminals PE Protective earth terminal

Mains part

F-type applied part

Applied part

Measuring device

Connection to accessible conductive parts

.........

Resistance measuring device

Optional connection

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 external ly .

- 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.

Safety Tests 3 Testing and Maintenance

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.

- 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. For testing the detachable power cord protective earth, use the setup pr ov ided with your safety analyzer. For testing the equipment leakage current and 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.

NOTE

Detachable Power Cord Protective Earth Test - Setup Example

Equipment Leakage Current and Applied Part Current Test - Setup Example

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

3 Testing and Maintenance Safety Tests

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.

ECG:

Safety Tests 3 Testing and Maintenance

SpO2 (MP2/X2, MP5, M3001A & M1020B #A01, #A02, #A03):

3 Testing and Maintenance Safety Tests

SpO2 (M1020A):

Safety Tests 3 Testing and Maintenance

Invasive Pressure:

3 Testing and Maintenance Safety Tests

M1006B #C01:

Temperature:

Safety Tests 3 Testing and Maintenance

CO2 (MP5, M3014A):

3 Testing and Maintenance Safety Tests

CO2 (M1016A, M3016A):

4 = all resistors 120 KOhm

Safety Tests 3 Testing and Maintenance

Cardiac Output:

3 Testing and Maintenance Safety Tests

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

Safety Tests 3 Testing and Maintenance

VueLink:

4 = 220 Ohm

3 Testing and Maintenance Safety Tests

IntelliBridge:

Safety Tests 3 Testing and Maintenance

EEG:

3 Testing and Maintenance Safety Tests

SvO2 (M1021A):

Safety Tests 3 Testing and Maintenance

ScvO2 (M1011A):

3 Testing and Maintenance Safety Tests

tcpO2/tcpCO2:

Safety Tests 3 Testing and Maintenance

MP5 predicitive Temperature:

3 Testing and Maintenance Safety Tests

MP5 TAAP:

Safety Tests 3 Testing and Maintenance

S(1): Detachable Power Cord Protective Earth Test (optional)

This test can be performed upon request by the customer. Test to perform: Use an Ohmmeter to measure the earth wire resistance of the detachable power cord. This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003

and CSA 601.1-M90. Report the highest value (X1).

Test Expected test results

Protective Earth Resistance Test X1 <= 100mOhms

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.

- Flex the power cord during the protective earth resistance test to eva luate its integrity. If it

does not pass the test, exchange the power cord.

- The functional earth conductor is required for EMC purposes. It has no protective function

against electrical shock. The protection against electrical shock is provided by double and/or reinforced insulation.

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

This test can be performed upon request by the customer. Test to perform:

3 Testing and Maintenance Safety Tests

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

This test measures the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 closed (Normal Condition). There is no exposed metal part or functional earth connector which can be used to attach a test lead.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003 and CSA 601.1-M90.

Report the highest value (X1).

Test Expected test results

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 (optional)

This test can be performed upon request by the customer. Test to perform:

Safety Tests 3 Testing and Maintenance

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

This test measures the functional earth leakage current. It tests normal and reversed polarity. Perform the test with S1 open (Single Fault Condition). There is no exposed metal part or functional earth connector which can be used to attach a test lead.

This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003 and CSA 601.1-M90.

Report the highest value (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.

3 Testing and Maintenance Safety Tests

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 invas ive bl ood pressure/temperature measurement block. This avoids a short and the potential of exceeding the limit for the current.

Test to perform:

Safety Tests 3 Testing and Maintenance

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 is no exposed metal part or functional earth connector which can be used to attach a test lead.

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

X1 <= 50μA

(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.

3 Testing and Maintenance System Test

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.

System Test 3 Testing and Maintenance

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.

3 Testing and Maintenance System Test

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.

- 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

60601-1-1.

- 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 socket-outlet 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.

System Test 3 Testing and Maintenance

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.

3 Testing and Maintenance System Test

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.

System Test 3 Testing and Maintenance

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 protect ive 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.

3 Testing and Maintenance System Test

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.

System Test 3 Testing and Maintenance

3 Testing and Maintenance System Test

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.

System Test 3 Testing and Maintenance

3 Testing and Maintenance System Test

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 eart h connec tion. 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.

System Test 3 Testing and Maintenance

3 Testing and Maintenance System Test

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.

System Test 3 Testing and Maintenance

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).

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

Test Expected test results

Equipment Leakage Current Test (Normal Condition)

Equipment Leakage Current Test (Single Fault Condition)

Sys1 <= 100μA

Sys2 <= 300μA

3 Testing and Maintenance Preventive Maintenance Procedures

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

Sys3 <= 300μA

Multiple Socket Outlets Refer to the documentation that accompanies the safety analy z er for further detai ls on how to s et

up the test.

Preventive Maintenance Procedures

Noninvasive Blood Pressure Measurement Calibration

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

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. If required, open the screen menu in the monitor info line at the top of the screen and select

Service to 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 for detailed information on when which test procedure is required.

Procedure: Power on the monitoring system and go into demo mode. Check that each connected parameter

(integrated, module, MMS, Gas Analyzer, Vuelink connected device) displays values.

Performance Assurance Tests 3 Testing and Maintenance

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.

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

1. Change the Patient Simulator configuration to:

- Base impedance line 1500 Ohm.

- Delta impedance 0.5 Ohm.

- Respiration rate 40 rpm or 45 rpm.

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

Test Expected test results

ECG Performance Test 100bpm +/- 2bpm or

Respiration Performance Test 40 rpm +/- 2 rpm or

120bpm +/- 2bpm

45 rpm +/- 2 rpm

3 Testing and Maintenance Performance Assurance Tests

ECG Sync Performance Test

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 Sync Performance Test Marker pulse is displayed before

SpO2 Performance Test

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

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

Test Expected test results

SpO2 Performance Test 95% and 100%

the T-wave begins

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

Performance Assurance Tests 3 Testing and Maintenance

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.

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:

3 Testing and Maintenance Performance Assurance Tests

Tools required:

- Reference manometer (includes hand pump and valve), accuracy 0.2% of reading.

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

- 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 on the MMS 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,

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

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

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

instrument to pump up the expansion chamber.Wait a few seconds after pumping stops until EnterPrVal is highlighted and then move the cursor to the value shown on the manometer. If one of the following prompt messages appears during this step, check whether there is leakage in the setup:

- NBP unable to calibrate–cannot adjust pressure

- NBP unable to calibrate–unstable signal

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.

Performance Assurance Tests 3 Testing and Maintenance

NBP Linearity Test

1. Reduce the manometer pressure to 150 mmHg.

2. Wait 10 seconds for the measurement to stabilize.

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

4. Document the value displayed by the monitor (x3)

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

accuracy test procedure).

Valve Test

1. Raise the pressure again to 280 mmHg.

2. Select Close valves: Off.

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

mmHg.

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

Expected Test Results for NBP Accuracy Test, Leakage Test, Linearity Test & Valve Test

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.

3 Testing and Maintenance Performance Assurance Tests

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.

Table 4:

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

Table 2:

Test Expected test results

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

M3014A Capnography Extension Performance Tests

The procedures below describe the mainstream and sidestream CO2 performance tests for the M3014A Capnography Extension.

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

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

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

2. Switch on the patient monitor.

3. Enter the monitor’s Service Mode.

Performance Assurance Tests 3 Testing and Maintenance

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

sensor to warm up to its operating temperature.

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

or below this value, correct the gas temperature setting.

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

Air

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

8. Set the gas correction to off.

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

expected value is 5% of the ambient pressure ±2mmHg

NOTE

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

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

Table 6:

Test Expected test results (x1) Acceptance Range

Mainstream CO2 Accuracy Test

NOTE

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

Sidestream CO2 Accuracy Check

Tools Required:

- Cal gas flow regulator M2267A

- Cal tube 13907A

- Verification Gas M2506A

- Straight Sample Line M2776A

Procedure:

5% of 760 mmHg pressure ±2mmHg

36 mmHg 40 mmHg

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

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

2. Switch on the patient monitor.

3. Enter the monitor’s Service Mode.

3 Testing and Maintenance Performance Assurance Tests

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.

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

expected value is 5% of the ambient pressure ±2mmHg

NOTE

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

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

Test Expected test results (x2) Acceptance Range

Sidestream CO2 Accuracy Test

5% of 760 mmHg pressure ±2mmHg

36 mmHg 40 mmHg

NOTE

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

Sidestream CO2 Flow Check

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

1. Connect the flowmeter to the sample line

2. Check on the flowmeter the flow that the Sidestream CO2 extension pump draws. It should

be 50 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.

Performance Assurance Tests 3 Testing and Maintenance

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

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:

- 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

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.

3 Testing and Maintenance Performance Assurance Tests

Leakage Check

The leakage check consists of checking the tubing between:

- the pump outlet and the mCO

outlet and

- 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

input to start the pump running.

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

pressure should be approximately 20 mmHg lower than ambient pressure.

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

5. Block the mCO

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

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

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

mCO

outlet.

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

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

Assembly of the MP5 respectively.

Part 2

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

M3015A gas outlet or the MP5 mCO

2. Leave the Filterline connected to the M3015A inlet or the MP5 mCO

gas outlet.

inlet..

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

gas inlet. If the connections

are good, try 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 must be exchanged.

assembly of the MP5

Performance Assurance Tests 3 Testing and Maintenance

Barometric Pressure Check and Calibration

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

Pump Check

1. Go into service mode and select Setup CO

2. Connect a FilterLine to the Microstream CO

menu.

input. This activates the pump in the M3015A

MMS Extension or the MP5.

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

pressure reading (ambient/cell)

xxx/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 CO

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

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.

1. Connect the flowmeter inlet to the mCO

gas outlet.

2. Connect the FilterLine to the mCO

3. 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:

1. Connect the flowmeter to the CO

2. Check on the flowmeter the flow that the M3015A MMS Extension or MP5 mCO2 pum p

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

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

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.

inlet.

FilterLine.

3 Testing and Maintenance Performance Assurance Tests

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

Noise Check

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

level of noise on the CO extension.

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

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 regul ator to allow 5% CO

the value to stabilize.

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

the calculated mmHg value ± 2.6 mmHg. If the value is outside the tolerance, calibrate as described in step in this procedure onwards.

menu.

value on the display (this indicates the

gas measurement as follows:

gas to flow into the extension. Allow

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

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

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

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

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

gas to flow into the extension.

Allow the value to stabilize.

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

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

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%.)

Performance Assurance Tests 3 Testing and Maintenance

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

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

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.

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)

Flow Check x5 = difference between measured value and 50.0

ml/min (x5<7.5 ml/min)

Noise Check x6 = noise index displayed on monitor (x6<3.0) CO2 Gas

Calibration Check

x7 = difference between measured CO2 value and calculated value, based on 5% CO

cal. gas. (x7 < 2.6

mmHg)

CO2 Cal Verification

x8 = difference between measured CO2 value and calculated value, based on 10% CO

cal. gas.

(x8 < ± {0.07 x value calculated})

3 Testing and Maintenance Performance Assurance Tests

Reset Time Counters

NOTE

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

You must check the time counters on the Microstream CO instrument. As well, when parts are replaced, the appropriate counters must be reset to zero.

The counters for CO

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

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

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

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

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

Resetting the PumpOpTime generate s the INOP: “CO must perform a flow check and store the flow in service mode (select Store Flow).

CO2 Pump / CO2 Scrubber Replacement

NOTE

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

extension before calibrating the

OCCLUSION”. To clear this INOP you

Refer to the Repair and Disassembly section for the replacement procedures.

Cardiac Output Performance Test

These tests check the performance of the cardiac output measurement.

1. Connect the patient simulator to the C.O. module using the patie nt cab le.

2. Configure the patient simulator as follows:

Injection temperature: 2 °C Computation Const: 0.542 (Edward's Catheter) Flow: 5 l/min

3. Check displayed value against the simulator configuratio n.

4. Expected test result: C.O. = 5 +/– 1 l/min.

Test Expected test results

Cardiac Output Performance Test C.O. = 5 +/– 1 l/min

Performance Assurance Tests 3 Testing and Maintenance

Service Tool Procedure, Version 1

This procedure applies for Service Tool M1012-61601 in combination with C.O. modules without option C10 and M3012A MMS extensions with option C05.

1. In monitoring mode, connect the C.O. interface cable to the module.

2. Connect one side of the service tool to the injectate receptacle of C.O. interface cable and

the other side to catheter cable receptacle.

3. Enter the C.O. Procedure window and check the results. The expected test result is:

Tblood = 37.0

C +/- 0.1oC

Test Expected test results

Cardiac Output Service Tool

Tblood = 37.0oC +/- 0.1oC

Procedure Version 1

Service Tool Procedure, Version 2

This procedure applies only for Service Tool M1012-61601 in combinatio n wit h C.O . m odules with option C10 and for the M3012A MMS Extension with option C10.

1. In monitoring mode, connect the C.O. interface cable to the module.

2. Connect one side of the service tool to the injectate receptacle of the C.O. interface cable

and the other side to the catheter cable receptacle.

3. Enter C.O. Procedure window and check results for:

- Method of measurement

- Arterial Catheter constant

- Tblood

The expected results are:

- Transpulmonary

- 341

- Tblood = 37.0

C +/- 0.1oC

4. Make sure the main alarms are switched on.

5. Disconnect the Catheter cable receptacle from the service tool

6. Enter the Setup C.O Window and change the method of measurement to “Right Heart”

7. Enter the C.O. Procedure window and check t he Tinj val ue. The expected res ul t is:

Tinj = 0.0

C +/- 0.1oC

Test Expected test results

Cardiac Output Service Tool Procedure Version 2

Tinj = 0.0oC +/- 0.1oC

3 Testing and Maintenance Performance Assurance Tests

Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed)

1. Switch on the monitor.

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

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

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

power or insert a battery

Test Expected test results

Power Loss Alarm Buzzer

Beep for one minute

Performance Test

IntelliVue 802.11 Bedside Adapter Communication Test

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 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.

- set SSID to match your installation.

- set the 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.

- set the Security Mode to WPA(PSK) and enter the WPA password (string between

8 and 63 characters).

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 Conn.Status field in the service window shows Authenticatd (for Rel. C.0 monitors)or Connected (for Rel D.0 or higher). Take the monitor approximately 5 m away from the access point. There should be no walls or other obstacles between the monitor and the access point. The following should apply:

Performance Assurance Tests 3 Testing and Maintenance

- Observe the 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 the RSSI value is significantly lower, check the distance to the access point and the antenna orientation at the monitor. The antenna orientation should be vertical, but the physical placement of the monitor or other equipment within its vicinity as well as walls or other obstacles may influence the antenna orientation required to receive the best RSSI value.

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

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

IIT Communication Test

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 Conn.Status field should be Active and the other fields should contain values. If the RSSI value is significantly lower, check the distance to the access point and the antenna orientation at both the monitor and the access point (both should be vertical).

- Remove the antenna. The RSSI value should be around -90 ±10. The IIT link may be

active but the connection could be unreliable. The Conn. Status field may toggle between Inactive and Seeking. If the difference between the RSSI values measured with and without antenna is significantly lower, check the antenna and the antenna connector for damage and verify that the cable fom the IIT adapter to the antenna connector plate is connected properly.

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

3 Testing and Maintenance Performance Assurance Tests

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 Conn. Status will slowly toggle between Inactive and Seeking.

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

Wireless Network Installation and Configuration Guide.

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 proc edure

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 3 Testing and Mainten ance

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.

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 shou ld incl ud e:

- Identification of the testing body (for example, which company or department carried out the

tests).

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

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

- The actual tests (incl. visual inspections, performance tests, safety and system tests) and

measurements required

- Date of testing and of the concluding evaluation.

- A record of the actual values of the test results, and whether these values passed or failed the

tests.

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

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

Carrying Out and Reporting Tests

Testing Organization: Name of testing person:

Responsible Organization: Device Under Test: ID-Number Product Number: Serial No.: Accessories:

Test Report

Test before putting into service (reference value) Recurrent Test

Test after Repair

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

Functional Test (parameters tested):

3 Testing and Maintenance Reporting of Test Results

Test Block

Visual Inspection

Test and Inspection Matrix

Test or Inspection to be Performed

Perform Visual Inspection

Power On Power on the

unit. Does the self-test complete successfully

Noninvasive Blood

Perform the

Accuracy Test Pressure Performance Tests

Performance

Leakage Test

Performance

Linearity Test

Record the Results (mandatory for

Expected Test Results

Philips Personnel only) What to record Actual Results

Pass or Fail V:P or V:F

If Yes, Power On test is

PO:P or PO:F

passed

X1 = value displayed by monitor

PN:P/X1 or PN:F/X1

Difference <= 3mmHg X2 = leakage test value X2 < 6 mmHg X3 = value displayed by

monitor

PN:P/X2 or PN:F/X2 PN:P/X3 or PN:F/X3

Difference <= 3mmHg

Performance

Valve Test

Temperature Performance Test

All other performance tests

Perform the

Temperature

Performance Test

Perform the

remaining

parameter

performance

tests, if applicable Safety (4) Perform Safety

Test (4): Patient

Leakage Current

- Single Fault

Condition, mains

on applied part. System

(Sys 1-2)

Perform the

system test

according to

subclause 19.201

of IEC/EN

60601-1-1, if

applicable, after

forming a system

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

PN:F/X4

X1= 40°C ± 0.2°C or 100°F ±

0.4°F

See expected results in test procedures

Maximum leakage current (X1): <=50 μA

Equipment Leakage Current: Sys1 <= 100 μA (Normal

Condition)

PT: P/X1 or PT: F/X1

P: P or P: F

S(4): P/X1 or S(4): F/X1

Sys: PSys1/PSys2 or

Sys: FSys1/Fsys2 Sys2 <= 300μA (Single Fault Condition

Reporting of Test Results 3 Testing and Mainten ance

Test or

Test Block

System (Sys 3)

Inspection to be Performed

Perform the system test according to subclause 19.201 of IEC/EN 60601-1-1, if applicable, after forming a system

Expected Test Results

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

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

Record the Results (mandatory for

Philips Personnel only)

What to record Actual

Results

Sys: PSys3

Sys: FSys3

Yes No

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

Notes:

Next Recurrent Test: Name:____________________________________________________ Date/Signature:_____________________________________________

Evaluation of Test Results

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

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

NOTE

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

3 Testing and Maintenance Other Regular Tests

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.

Locking/Unlocking Touch Operation

To temporarily disable touchscreen operation of the monitor, press and hold the Main Screen key. The message “Touch disabled, press Main Screen” will appear on the screen. Press and hold

the Main Screen key again to re-enable touchscreen operation.

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 it. Additionally, some good working practices are also given regarding the correct disposal of the battery.

NOTE

If your MP2/X2 is connected to an IntelliVue Information Center, you should make sure that the IIC uses the text catalog revision F.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

When monitoring a patient, one Philips M4607A rechargeable Lithium Ion battery must always be inserted into the battery compartment on the right side of the MP2/X2. This applies even when you are running the MP2/X2 external power, either via the external power supply or when connected to a host monitor. The battery has the effect of sealing the battery compartment, thereby preventing the ingress of fluids or foreign bodies. A severe yellow INOP (!!INSERT BATTERY) will be issued if the monitor is connected to AC mains without a battery fully inserted in the battery compartment. This INOP will persist until a battery is loaded.

Battery Handling, Maintenance and Good Practices 3 Testing and Maintenan ce

To use the MP2/X2 with battery power, disconnect it from the host monitor or the external power supply (M8023A).

The rechargeable Lithium-Ion Mangan battery used in the MP2/X2 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 battery, 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 MP2/X2.

- Capabilities of integrated battery charger: 10.8 V, 1 mAh (typ.)

Actual current / voltage: depends on smart battery request and monitor configuration The approximate charging time is 2 hours with the monitor switched off and up to 12 hours or more during monitor operation, depending on the monitor configuration.

Checking the Battery Status

When the MP2/X2 is connected to the external power supply (M8023A), the battery charges automatically. The battery can be charged remotely from the MP2/X2 by using the battery charger. Use only the M8043A Smart battery charger with the additional adapter.

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 yellow, or red depending on the following conditions:

Battery LED Colors If the MP2/X2 is connected

to a host monitor or

If the monitor is running on

battery power, this means external power supply , this means

battery charging

Yellow

Red, flashing

Red, flashes intermittently

indicated by malfunction symbol and INOP

for further details see Troubleshooting section

malfunction

battery or charger

1,2

≤ 10 minutes power remaining

battery or charger

malfunction

1,2

3 Testing and Maintenance Battery Handling, Maintenance and Good Practices

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, with the battery power remaining and, when the battery is not charging, an estimate of the monitoring time this represents.

Battery power gauge: This shows the remaining battery power. It is divided into sections, each representing 20% of the

total power. If three sections are filled, as in this example, this indicates that 60% battery power remains. If no battery is detected, a blank battery gauge marked with a flashing red X is displayed. If no data is available from the battery, a question mark is shown in the gauge.

Battery status/malfunction indicator: Normal battery function is indicated by the battery power gauge, together with the remaining

operating time, on the Main Screen. You are informed of problems or changes in the status of the battery by the battery status/malfunction indicator. This consists of a blank battery gauge containing a symbol. If the symbol is red, this indicates a critical situation. You can check the specific cause of the problem by looking at the symbol(s) displayed in the Battery Status window.

Battery status indicator Battery malfunction indicator

Alternates with the battery gauge on the Main

Screen.

Check in the window to see which status symbol is dis pl ay e d

to identify the cause.

Battery Status

The red ! flashes. Critical battery situation or malfunction. Check in the

Battery Status window

to see which malfunction ind icator is displayed, or refer to the INOP, to identify the cause.

Indicator for missing battery (flashing red X). An INOP is issued when the battery compartment is empty, and the MP2/X2 is connected to external power (a host monitor or the optional external

power supply). This

BATTERY

15 seconds while the monitor is connected to AC mains power, allowing you sufficient time to load a new battery. After silencing, the INOP reappears every 10 seconds until a battery is loaded.

!!INSERT

INOP is suppressed for

100

Philips IntelliVue MP User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction

Who Should Use This Guide

How to Use This Guide

Responsibility of the Manufacturer

Passwords

Warnings and Cautions

2Theory of Operation

Monitor Theory of Operation

System Boundaries

Hardware Building Blocks

IntelliVue MP2

IntelliVue X2

Optional Hardware

Power Distribution

System Interfaces

Compatible Devices

Data Flow

Data Acquisition

Data Provider System Service

Persistent Data Storage System Service

Display and User Interface Service

Monitor Applications

Internal LAN (Measurement Link)

Philips Clinical Network

How does the Support Tool Work with the Monitor

Monitor Software Block Diagram

Block Diagram Legend

3Testing and Maintenance

Introduction

Terminology and Definitions

Recommended Frequency

When to Perform Tests

Testing Sequence

Visual Inspection

Before Each Use

After Each Service, Maintenance or Repair Event

Power On Test

Safety Tests

Warnings, Cautions, and Safety Precautions

Safety Test Procedures

Hints for Correct Performance of Safety Tests

Guideline for Performance of Safety Tests

Safety Test Adapter Cable - Schematics

S(1): Detachable Power Cord Protective Earth Test (optional)

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

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

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

System Test

What is a Medical Electrical System?

General Requirements for a System

System Example

System Installation Requirements

Required Protective Measures at System Installation

Case 1: Medical Device Combined with Medical Device

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

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

System Test Procedure

Preventive Maintenance Procedures

Noninvasive Blood Pressure Measurement Calibration

Performance Assurance Tests

Basic Performance Assurance Test

Full Performance Assurance Test

ECG/Resp Performance Test

ECG Performance

Respiration Performance

ECG Sync Performance Test

SpO2 Performance Test

Measurement Validation

NBP PerformanceTest

NBP Accuracy Test

NBP Leakage Test

NBP Linearity Test

Valve Test

Invasive Pressure Performance Test

Temperature Performance Test

M3014A Capnography Extension Performance Tests