Philips Intellivue MP5 User manual

4.5 (6)

Service Guide

IntelliVue Patient Monitor

MP5/MP5T/MP5SC

Rel. L.x

Patient Monitoring

Table of Contents

 

1 Introduction

7

Who Should Use This Guide

7

How to Use This Guide

7

Abbreviations

7

Responsibility of the Manufacturer

7

Passwords

8

Warnings and Cautions

8

 

2 Theory of Operation

9

Monitor Theory of Operation

9

 

3 Testing and Maintenance

25

Introduction

25

Terminology and Definitions

25

Recommended Frequency

26

When to Perform Tests

27

Testing Sequence

30

Visual Inspection

30

Safety Tests

31

System Test

55

Preventive Maintenance Procedures

66

Performance Assurance Tests

66

Reporting of Test Results

92

Other Regular Tests

95

Touchscreen Calibration

95

Disabling/Enabling Touch Operation

96

Printer Test Report

96

Battery Handling, Maintenance and Good Practices

97

After Installation, Testing or Repair

105

 

4 Troubleshooting

107

Introduction

107

How To Use This Section

107

Who Should Perform Repairs

107

Replacement Level Supported

107

Software Revision Check

108

Software Compatibility Matrix

108

Obtaining Replacement Parts

108

Troubleshooting Guide

108

3

 

5 Repair and Disassembly

 

135

Who Should Perform Repairs

135

Tools required

136

Removing the Handle or Bedhanger

136

Removing the Predictive Temperature Assembly

137

Disassembling the Predictive Temperature Assembly

139

Removing/Exchanging the NBP Inlet

140

Separating the Front and Back of the Monitor

142

Removing the Recorder Slot Cover

146

Removing the Internal Quick Mount Solution

147

Removing the Short Range Radio (SRR) Interface

147

Removing the IntelliVue 802.11 Bedside Adapter Antenna or IIT Antenna (not for MP5T)

149

Removing the IntelliVue 802.11 Bedside Adapter (WLAN) (not for MP5T)

149

Removing the IntelliVue Instrument Telemetry (IIT) Module (not for MP5T and MP5SC)

153

Removing the IntelliVue 802.11 Bedside Adapter/IIT Holder

154

Removing the MSL Board (not for MP5T and MP5SC)

155

Removing the Backlight Inverter Board (Old NEC Display)

156

Removing the Backlight Converter Board (New NLT Display)

158

Removing the Power Supply

159

Removing the System Interface Board

160

Removing the Recorder Board

161

Removing the Microstream CO2 Assembly

163

Removing the Measurement Block

169

Removing the NBP Pump

173

Removing the Main Board

175

Removing the Touch Assembly

178

Removing the Loudspeaker

180

Removing the Power Button and LED Assembly

180

Removing the LCD Panel

181

Exchanging the Backlight (Old NEC Display only)

182

Modifying the Nurse Call Relay

183

 

6 Parts

 

187

MP5/MP5T/MP5SC Parts

187

External Display Part Numbers (not for MP5T)

201

Tympanic Thermometer Part Numbers

203

Smart Battery Charger Part Numbers

203

Test and Service Tools

204

 

7 Installation Instructions

207

 

 

 

 

Out-Of-Hospital Transport - Standards Compliance

207

Electromagnetic Emissions

209

Electromagnetic Interference (SRR)

209

Installation Checklist

209

Unpacking and Checking the Shipment

210

Installing the Predictive Temperature Probe

211

4

Installing the Tympanic Thermometer

213

Installing the HS1-R Barcode Reader

216

Mounting the Monitor

226

Connecting the Monitor to AC Mains

233

Checking Out The Monitor

233

Loading Paper

236

Configuration Tasks

236

Network Configuration Tasks (Rev H.0 or higher)

239

Handing Over the Monitor

248

Installing Remote Devices (not for MP5T)

249

Clinical Network (Wired and Wireless)

251

Philips IntelliVue Information Center

251

IntelliVue Instrument Telemetry (IIT)(not for MP5T and MP5SC)

251

Short Range Radio

252

Connecting the MP5 to a Host Monitor (not for MP5T and MP5SC)

255

Nurse Call Relay (not for MP5T)

255

ECG Out Functionality (ECG Sync) (not for MP5T and MP5SC)

256

ECG Sync Pulse (not for MP5T and MP5SC)

256

 

8 Site Preparation

259

Introduction

259

Monitor Site Requirements

261

Remote Device Site Requirements

262

Remote Displays (M8031B)

264

Remote Displays - M8033C

264

Cabling Options and Conduit Size Requirements

265

Touch Cable

266

MSL Cables

266

Philips Medical LAN

267

LAN Interface

267

Telemetry Device (Patient Worn Device) cables

268

Nurse Call Relay Interface

268

ECG Out Interface

269

 

9 Gas Analyzers (not for MP5T and MP5SC)

271

10 Specifications

273

Essential Performance Characteristics

273

MDD Classification

275

Classification According to IEC 60601-1

275

Safety and Regulatory Information

275

Use Environment

275

Disconnecting from Power

276

Symbols

276

Physical Specifications

278

Environmental Specifications

278

5

6

1

Introduction

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

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

Who Should Use This Guide

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

How to Use This Guide

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

Abbreviations

Abbreviations used throughout this guide are:

 

Name

Abbreviation

IntelliVue MP5/MP5T/MP5SC Patient Monitor

the monitor

Medical Information Bus

MIB

Responsibility of the Manufacturer

 

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

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

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

7

1 Introduction

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

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

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

Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str. 2

71034 Böblingen, Germany

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

Philips makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose.

Philips shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Passwords

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

CAUTION

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

Monitoring Mode: No password required Configuration Mode: 71034

Demo Mode: 14432

Service Mode: 1345

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

Warnings and Cautions

In this guide:

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

A caution alerts you where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

8

2

Theory of Operation

Monitor Theory of Operation

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

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

The monitor can be configured with various different measurement and interface capabilities. The following comparison table shows in detail the differences between MP5, MP5T and MP5SC:

Functionality (including optional features)

MP5

MP5T

MP5SC

 

 

 

 

ECG

yes

no

no

SpO2

yes

yes

yes

NBP

yes

yes

yes

Predictive Temperature

yes

yes

yes

Temperature

yes

no

no

Invasive Pressure

yes

no

no

Carbon Dioxide

yes

no

no

Microstream CO2

yes

no

yes

Direct Telemetry Connection

yes

yes

no

ECG Output signal

yes

no

no

LAN networking capability

yes

no

yes*

WLAN networking capability

yes

no

yes*

IntelliVue Instrument Telemetry networking capability

yes

no

no

USB Interface

yes

no

yes

Short Range Radio capability

yes

yes

yes

 

 

 

 

9

2 Theory of Operation

Functionality (including optional features)

MP5

MP5T

MP5SC

 

 

 

 

Severe Sepsis Screening

yes

no

no

OxyCRG high resolution trend

yes

no

no

Neonatal event review

yes

no

no

Integrated recorder

yes

yes

yes

Drug Calculator

yes

yes

no

Gas monitor support

yes

no

no

Connection to a host monitor (companion mode)

yes

no

no

Connection to an external display

yes

no

yes

Nurse call capability

yes

no

yes

Spot Check

yes

no

yes

Multi-Patient Spot Check

no

no

yes

Early Warning Score

yes

no

yes

 

 

 

 

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

NOTE

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

System Boundaries

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

System Boundaries

10

2 Theory of Operation

Measurement connections

Built-in measurement block

Philips Clinical Network (wired LAN)

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

Philips Clinical Network (wireless)

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

Hospital LAN, Internet

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

11

Philips Intellivue MP5 User manual

2 Theory of Operation

Hardware Building Blocks

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

MP5/MP5T/MP5SC Hardware Building Blocks

12

2 Theory of Operation

IntelliVue MP5/MP5T/MP5SC

The MP5/MP5T/MP5SC monitor:

integrates the display and processing unit into a single package

uses a 8.4” TFT SVGA color display

uses the Touchscreen as input device

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

Optional Hardware

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

optional recorder

optional battery

optional MSL board

optional Short Range Radio (SRR) board

Power Distribution

Power Distribution Architecture

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

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

13

2 Theory of Operation

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

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

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

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

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

NOTE

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

System Interfaces

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

System Interface boards:

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

Battery: LAN, Battery Board, mCO2 #J02

Full: LAN, Battery, MIB/RS232, Video, Nurse Call, mCO2 #J40

Full USB: LAN, Battery, USB, Video, Nurse Call, mCO2 #J43

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

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

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

14

2 Theory of Operation

Compatible Devices (not for MP5T and MP5SC)

IntelliVue G1/G5 Anesthetic Gas Module

Data Flow

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

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

15

2Theory of Operation

Server systems on the Philips Clinical Network

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

Data Provider System Service

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

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

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

Persistent Data Storage System Service

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

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

Display and User Interface Service

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

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

Monitor Applications

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

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

Internal LAN (Measurement Link)

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

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

16

2 Theory of Operation

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

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

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

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

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

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

NOTE

The MP5 does not support any MMS on the MSL.

Microstream CO2

CO2 sample rate: 20 samples/second Calculation of end tidal CO2 (etCO2):

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

end of exhalation (etCO2), the amount of CO2 present during inhalation (imCO2), and the respiratory rate. The displayed etCO2 is the maximum etCO2 over the previous peak-picking interval as defined by

the Max Hold setting (configuration mode). It can be set to no peak picking (off), 10 seconds and 20 seconds.

Test method for respiration rate range:

A breath simulator system combined with CO2 and N2 gases was used to simulate respiration rates covering the specified range. The resulting end tidal CO2 values were compared to the expected value. Differences between actual and expected end tidal CO2 values were within the limits of the specified

accuracy for the respective respiration rate, i.e. there was no effect of the respiration rate on the end tidal CO2 values beyond those limits.

Philips Clinical Network

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

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

17

2 Theory of Operation

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

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

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

How does the Support Tool Work with the Monitor

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

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

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

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

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

18

2 Theory of Operation

Monitor Software Block Diagram

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

IntelliVue Patient Monitoring System Functional Block Diagram

19

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.

Record

The Record Service retrieves current and stored physiological

 

data and status data to format a continuous strip recording. A

 

recording can be triggered manually by the operator or

 

automatically by an alarm condition. The Record Service uses

 

the services of the Recorder Interface to control a recorder.

 

The Record Service can also send data to a central recorder.

 

 

 

20

2 Theory of Operation

Functional Block

Description

 

 

Alarm

The Alarm Service contains logic that prioritizes alarm

 

conditions that are generated by IntelliVue Patient Monitoring

 

System software modules. Visual alarm signals (messages) are

 

displayed at the top of the IntelliVue Patient Monitoring

 

System display and alarm sounds are generated by a

 

loudspeaker. Alarm conditions may be generated when a

 

physiological parameter exceeds preselected alarm limits or

 

when a physiological parameter or any other software module

 

reports an inoperative status (technical alarm, for example, the

 

ECG leads may have fallen off the patient). The Alarm service

 

manages the alarm inactivation states, for example suspension

 

of alarms, silencing of alarms, and alarm reminder. Alarm

 

signals may also be configured as latching (alarm signals are

 

issued until they are acknowledged by the operator, even

 

when the alarm condition is no longer true). The Alarm

 

service controls the visual alarm signals (alarm lamps).

Trend

The Trend service stores the sample values of physiological

 

data and status data with a resolution of 12 seconds, 1 minute

 

or 5 minutes for a period of up to 48 hours. The data is kept

 

in battery buffered read/write storage and flash memory

 

devices to be preserved across power failures. The stored data

 

is protected via consistency checks and checksums. When a

 

new patient is admitted, the trend database erases all data of

 

the previous patient.

OxyCRG

The OxyCRG (Oxygen CardioRespiroGram) service derives a

 

high-resolution trend graph from the Beat-to-Beat Heart

 

Rate, SpO2, and Respiration physiological data. The OxyCRG

 

is specialized for neonatal applications, allowing the operator

 

to identify sudden drops in Heart Rate (Bradycardia) and

 

SpO2 (Desaturation), and supporting the operator in

 

visualizing Apnea situations.

ADT

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

 

patient demographics information. The operator may admit a

 

new patient, discharge the old patient and enter or modify the

 

patient demographics.

Calc Param

The Calc Param (Calculated Parameters) application performs

 

calculations on physiological numerical values to derive

 

calculated parameters like Temperature Difference.

Interface Managers

 

 

 

21

2 Theory of Operation

Functional Block

Description

 

 

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.

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

 

 

 

22

2 Theory of Operation

Functional Block

Description

 

 

LAN

The LAN interface implements the physical layer of IEEE

 

802.3. The LAN interface performs Manchester encoding/

 

decoding, receive clock recovery, transmit pulse shaping,

 

jabber, link integrity testing, reverse polarity detection/

 

correction, electrical isolation, and ESD protection.

 

Electronically separated interfaces are used for

 

communication to the Measurement parameters and to the

 

network.

Display Controller

The Display Controller Interface consists of a video

 

controller, video RAM and the controlling software. The

 

Display Controller interface processes the high level display

 

commands (character and graphic generation, wave drawing)

 

and translates them into pixels, which are written into the

 

video RAM where the video controller chip generates the

 

video synchronization signals and the pixel stream for the

 

Color LCD Display.

HIF Control

The HIF (Human Interface Control) interface scans the

 

Human Interface devices for operator controls (Touch

 

Screen), formats the collected data and sends it to the display

 

and Operating Interface.

ECG-Out Marker-In

The ECG Out/Marker In interface receives the ECG

(not for MP5T and MP5SC)

waveform directly from the ECG/Resp Arrhythmia ST-

 

Segment physiological algorithm running on the main CPU

 

and converts the digital ECG signal to an analog ECG signal.

 

In addition, the ECG Out hardware receives from a

 

connected device the marker information and forwards this

 

data to the ECG/Resp Arrhythmia ST-Segment physiological

 

algorithm. The converted analog signal is used to synchronize

 

a connected device to the patient’s ECG

Nurse Call

The Nurse Call board contains a phone jack type connector

(not for MP5T)

with a single close-on-alarm relay.

MIB

The MIB interface allows full-duplex, short-haul

(not for MP5T and MP5SC)

asynchronous binary communication between the monitor

 

and an arbitrary (medical/non-medical) device using an eight-

 

pin RJ45 modular connector. Communication protocols using

 

this interface can be configured.

ECG Sync Out

A pulse signal is provided on the RS-232 interface to allow

(not for MP5T and MP5SC)

synchronisation with other medical devices.

IIT

The built-in IIT adapter allows operation of the MP5

(not for MP5T and MP5SC)

monitors within IntelliVue Instrument Telemetry

 

infrastructure.

WLAN

The bulit-in WLAN interface allows wireless operation of the

(not for MP5T)

MP5 monitors with the IntelliVue 802.11 Bedside Adapter.

SRR

The built-in SRR interface allows wireless communication of

 

the MP5, MP5T and MP5SC monitors with an IntelliVue

 

Instrument Telemetry Transceiver.

 

 

23

2 Theory of Operation

Functional Block

Description

 

 

MSL

All components of the monitoring system communicate using

(not for MP5T and MP5SC)

an IEEE802.3/ Ethernet LAN in the Measurement Link

 

(MSL). This network is used to distribute data between the

 

components

USB Interface

The USB interface allows connection of USB devices (Mouse,

(not for MP5T)

Keyboard, Barcode Scanner) to the monitor. Note that USB

 

printers are not supported.

 

 

24

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.

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

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

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

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

Terminology and Definitions

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

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

Patient Environment: any area in which intentional or unintentional contact can occur between the patient and parts of the medical system or between the patient and other persons who have had contact with parts of the medical system. The patient environment is defined anywhere within 1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.

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

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

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

25

3 Testing and Maintenance

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

Recommended Frequency

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

Tests

 

 

Frequency

 

 

 

Preventive

NBP Performance

Once every two years, or more

Maintenance

 

 

often if specified by local laws.

 

Microstream CO2 Calibration1

Once a year or after 4000 hours

 

 

 

of continuous use and following

 

 

 

any instrument repairs or the

 

 

 

replacement of any instrument

 

 

 

parts.

 

Tympanic Temperature Calibration

Once a year. If the unit is

 

 

 

dropped or damaged, check it

 

 

 

and calibrate it before further

 

 

 

use.

Other Regular Tests

Visual Inspection

Before each use.

 

Power On Test

 

 

Performance

ECG/Resp Performance

Once every two years, or if you

Assurance Tests

ECG Out Sync Performance1,2

suspect the measurement is

 

 

 

incorrect, except Mainstream

 

ECG Sync Pulse Performance1,2

 

CO2 Accuracy Check,

 

SpO2 Performance

Sidestream CO2 Accuracy Check

 

NBP Performance

and Flow Check and Predictive

 

Temperature Accuracy Check -

 

Invasive Pressure Performance1,2

 

required once a year.

 

Temperature Accuracy1,2

 

 

Predictive Temperature Accuracy

 

 

Check

 

 

 

Mainstream CO2 Accuracy Check1,2

 

 

Sidestream CO

Accuracy Check and

 

 

1,2

2

 

 

Flow Check

 

 

 

Microstream CO2 Performance Test1

 

 

Nurse Call Relay Performance1

 

 

Power Loss Alarm Buzzer

 

 

Performance

 

 

 

MSL Assurance Test1,2

 

 

Mounting Integrity Test

 

 

Battery Performance

 

 

 

 

 

26

 

 

 

3 Testing and Maintenance

 

 

 

 

 

Tests

 

 

Frequency

 

 

 

 

 

 

Safety

Visual

Visual Inspection

After each service event

 

Tests

 

 

 

 

Electrical

Protective Earth

Once every two years and after

 

 

 

 

 

 

repairs where the power supply

 

 

 

Equipment Leakage Current

 

 

 

has been removed or replaced or

 

 

 

Patient Leakage Current

 

 

 

the monitor has been damaged

 

 

 

 

 

 

 

 

by impact.

 

 

 

System Test

Once every two years

 

 

 

 

 

 

1These tests do not apply for MP5T.

2These tests do not apply for MP5SC

When to Perform Tests

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

Service Event

Tests Required

(When performing...

...Complete these tests)

 

 

Installation

 

 

 

Installation of a monitor in combination with a

Perform Visual Inspection, Power On and System

medical or non-medical device connected to the

Tests

same multiple socket outlet.

 

 

 

Installation of a standalone monitor with no

Perform Visual Inspection and Power On Test

display connected to the video output

 

Installation of a monitor with a medical display

Perform Visual Inspection and Power On Test

specified by Philips

 

 

 

Installation of a monitor with an off-the-shelf

Perform Visual Inspection, Power On and System

display (non-compliant with IEC60601-1)

Test

 

 

Installation of a monitor with IntelliVue G1/

Perform Visual Inspection and Power On Tests

G5, connected to separate mains sockets.

 

Installation of monitor with IntelliVue

Perform Visual Inspection, Power On and IIT

Instrument Telemetry (IIT)

communication test

 

 

Installation of a monitor with IT equipment e.g.

Perform Visual Inspection, Power On and System

PC connected via a functional connection e.g.

Tests

Centronics or USB.

 

 

 

Installation of monitor with IntelliVue 802.11

Perform Visual Inspection, Power On and

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

 

 

27

3 Testing and Maintenance

Service Event

Tests Required

(When performing...

...Complete these tests)

 

 

 

Preventive Maintenance

 

 

 

 

Preventive Maintenance*

Perform preventive maintenance tests and

 

procedures:

 

NBP calibration

 

Microstream CO2 calibration

 

Tympanic Temperature Calibration

 

 

 

Other Regular Tests and Tasks

 

 

 

 

Visual Inspection

Perform Visual Inspection

 

 

Power On Test

Perform Power On test

 

 

 

Repairs

 

 

 

 

Repairs where the monitor has been damaged by

Perform Visual Inspection, Power On, all Safety

impact, liquid ingression, fire, short circuit or

Tests and Full Performance Assurance Tests

electrical surge.

 

 

 

 

Repairs where the power supply, the mains

Perform Visual Inspection, Power On, all Safety

socket or an interface board is removed or

Tests and Basic Performance Assurance Test

replaced or the protective earth ground

 

 

connection is disrupted.

 

 

 

 

Repairs where the main board has been replaced.

Perform Visual Inspection, Power On, Basic

 

Performance Assurance Test and NBP Accuracy

 

Test and Calibration.

 

 

Repairs where the measurement block has been

Perform Visual Inspection, Power On, all Safety

removed or replaced

Tests and Basic Performance Assurance Test.

 

If a certain parameter seems suspicious, perform

 

Full Performance Assurance Test for this

 

parameter.

 

 

Repairs where the NBP pump has been replaced

Perform Visual Inspection, Power On, all Safety

 

Tests, Basic Performance Assurance Test and NBP

 

Performance Test and Calibration

 

 

Repairs of IntelliVue Instrument Telemetry (IIT)

Perform Visual Inspection, Power On Test Block

Module

and IIT communication test

 

 

Repairs of IntelliVue 802.11 Bedside Adapter

Perform Visual Inspection, Power On and

 

IntelliVue 802.11 Bedside Adapter

 

Communication Test

 

 

Repairs of Short Range Radio (SRR) Interface

Perform Visual Inspection, Power On and SRR

 

Communication Test

 

 

Repairs of the IntelliVue G1/G5

Perform Basic Performance Assurance Test. For

 

further testing requirements, see IntelliVue G1/

 

G5 Service Guide

 

 

Repairs where the Quick Mount has been

Perform Mounting Integrity Test

disassembled

 

 

 

 

All other IntelliVue Monitoring System repairs

Perform Visual Inspection, Power On Test and

(except when power supply is removed)

Basic Performance Assurance Test

 

 

 

28

 

3 Testing and Maintenance

 

 

Service Event

Tests Required

(When performing...

...Complete these tests)

 

 

Performance Assurance

 

 

 

Basic Performance Assurance

Perform basic performance assurance tests for the

 

respective monitoring system component.

 

 

Full Performance Assurance

Perform all accuracy and performance test

 

procedures listed in the following sections. If a

 

particular measurement is in question, perform the

 

measurement performance test only.

 

 

Upgrades

 

 

 

Software Upgrades

Perform Visual Inspection, Power On Test and

 

Basic Performance Assurance Test unless

 

otherwise specified in the Upgrade Installation

 

Notes shipped with the upgrade.

 

 

Hardware Upgrades

Perform Visual Inspection, Power On Test and

 

Basic Performance Assurance Test unless

 

otherwise specified in the Upgrade Installation

 

Notes shipped with the upgrade.

 

 

Hardware Upgrades where IntelliVue

Perform Visual Inspection, Power On Test, Basic

Instrument Telemetry (IIT) is installed

Performance Assurance Test and IIT

 

communication Test

 

 

Hardware Upgrades where IntelliVue 802.11

Perform Visual Inspection, Power On Test, Basic

Bedside Adapter is installed

Performance Assurance Test and IntelliVue 802.11

 

Bedside Adapter Communication Test

 

 

Hardware Upgrades where Short Range Radio

Perform Visual Inspection, Power On Test, Basic

(SRR) is installed

Performance Assurance Test and SRR

 

communication Test

 

 

Installation of Interfaces or Hardware Upgrades

Perform Visual Inspection, Power On Test, Basic

where the power supply or parameter boards

Performance Tests and all Safety Tests

need to be removed.

 

 

 

Combining or Exchanging System

Perform the System Test for the respective system

Components (non-medical equipment

components

connected to an IntelliVue monitor or medical

 

system equipment operated on a multiple socket

 

outlet)

 

 

 

NOTE

 

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

29

3 Testing and Maintenance

Testing Sequence

Summary of the recommended sequence of testing:

NOTE

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

Visual Inspection

Before Each Use

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

After Each Service, Maintenance or Repair Event

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

the integrity of mechanical parts, internally and externally.

any damage or contamination, internally and externally

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