Philips IntelliVue MP2 Service manual

4.6 (19)

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

 

3

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

4

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/Exchanging the SRR Board

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

5

Smart Battery Charger Part Numbers

197

 

7 Installation Instructions

199

Out-Of-Hospital Transport - Standards Compliance

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

6

 

9 MP2/X2 Product Structure

231

Upgrades

238

 

10

Default Settings Appendix

241

Country-Specific Default Settings

241

 

11

Index

251

7

8

1

Introduction

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 table of contents at the left of the screen to select the desired topic. Links to other relevant sections are also provided within the individual topics. In addition, scrolling through the topics with the page up and page down keys is also possible.

9

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.

10

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 effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

11

1 Introduction

Warnings and Cautions

12

2

Theory 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

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

NOTE

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

13

Philips IntelliVue MP2 Service manual

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

14

Monitor Theory of Operation

2 Theory of Operation

Hardware Building Blocks

The following hardware building blocks make up the monitoring system:

MP2/X2 Hardware Building Blocks

IntelliVue MP2

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

15

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

16

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.

17

2 Theory of Operation

Monitor Theory of Operation

Compatible Devices

M3012A, M3014A, M3015A, M3016A MMS Extensions

NOTE

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.

18

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

Data

Data

Interface

Applications

Acquisition

Provider

 

Service

 

Persistent

Data

Data

Output

Storage

 

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

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

-External measurement devices

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

-Server systems on the Philips Clinical Network

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

19

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.

20

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 example:

-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.

21

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 components in the system over the network.

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

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

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

Monitor Software Block Diagram

The 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

22

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.

 

 

 

23

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.

 

 

24

Monitor Theory of Operation

2 Theory of Operation

 

 

 

Functional Block

 

Description

Display & Operator

 

The Display and Operator Interface Manager performs the following tasks:

Interface

 

- 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

 

 

 

25

3

Testing 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.

27

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.

28

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.

Table 1: Suggested Testing Timetable

Tests

NBP Performance

Preventive Maintenance*

Microstream CO2 Calibration

 

Other Regular Tests

 

Visual Inspection

 

 

 

 

 

Power On Test

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Performance Assurance

 

ECG/Resp Performance

 

 

 

 

ECG Sync Pulse Performance

 

Tests

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SpO2 Performance

 

 

 

 

 

 

 

 

 

 

 

 

 

NBP Performance

 

 

 

 

 

 

 

 

 

 

 

 

 

Invasive Pressure Performance

 

 

 

 

 

 

 

 

 

 

 

 

 

Temperature Accuracy

 

 

 

 

 

 

 

 

 

 

 

 

 

M3014A Capnography Extension

 

 

 

 

 

 

Performance Tests

 

 

 

 

 

 

 

 

 

 

 

 

 

Microstream CO2 Performance Test

 

 

 

 

 

 

 

 

 

 

 

 

 

C.O. Performance Test

 

Safety

 

 

Visual

Visual Inspection

 

 

 

 

 

Tests

 

 

Electrical

 

Protective Earth

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equipment Leakage Current

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Patient Leakage Current

 

 

 

 

 

 

 

 

 

 

 

 

 

System Test

 

 

 

 

 

 

 

Frequency

Once every two years, or more often if specified by local laws.

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

Before each use.

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.

After each service event.

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

Once every two years

*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the CO2 pump/CO2 scrubber replacement procedure. This is required every three years or after 15000 operating hours.

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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

Tests Required

(When performing...

...Complete these tests)

Installation

 

 

 

 

Installation of a monitor in combination with

Perform Visual Inspection, Power On and

a medical or non-medical device connected to

System Tests

the same multiple socket outlet.

 

 

 

 

Installation of monitor with IntelliVue

Perform Visual Inspection, Power On and IIT

Instrument Telemetry (IIT)

communication test

 

 

Installation of monitor with IntelliVue

Perform Visual Inspection, Power On and

802.11 Bedside Adapter

IntelliVue 802.11 Bedside Adapter

 

Communication Test

 

 

Installation of a monitor with Short Range

Perform Visual Inspection, Power On and SRR

Radio (SRR)

communication test

 

 

Installation of networked monitor (LAN)

Perform Visual Inspection and Power On Test

 

 

 

Preventive Maintenance

 

 

 

 

Preventive Maintenance*

Perform preventive maintenance tests and

 

procedures:

 

-

NBP calibration

 

-

Microstream CO2 calibration

Other Regular Tests and Tasks

 

 

 

 

Visual Inspection

Perform Visual Inspection test block

 

 

 

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