Philips Intellivue MP5 User manual

Service Guide

IntelliVue Patient Monitor

MP5/MP5T/MP5SC

Rel. L.x

Patient Monitoring

1Table of Contents

1 Introduction 7

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

2 Theory of Operation 9

Monitor Theory of Operation 9

3 Testing and Maintenance 25

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

4 Troubleshooting 107

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

5 Repair and Disassembly 135

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

6 Parts 187

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

7 Installation Instructions 207

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

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

8 Site Preparation 259

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

9 Gas Analyzers (not for MP5T and MP5SC) 271

10 Specifications 273

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

1Introduction

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

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

Who Should Use This Guide

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

How to Use This Guide

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

Abbreviations

Abbreviations used throughout this guide are:

Name Abbreviation

IntelliVue MP5/MP5T/MP5SC Patient Monitor the monitor

Medical Information Bus MIB

Responsibility of the Manufacturer

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

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

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

1Introduction

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

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

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

Philips Medizin Systeme Böblingen GmbH

Hewlett-Packard Str. 2

71034 Böblingen, Germany

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

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

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

Passwords

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

CAUTION

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

Monitoring Mode: No password required

Configuration Mode: 71034

Demo Mode: 14432

Service Mode: 1345

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

Warnings and Cautions

In this guide:

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

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

2Theory of Operation

Monitor Theory of Operation

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

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

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

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

Functionality (including optional features) MP5 MP5T MP5SC

ECG yes no no

SpO2 yes yes yes

NBP yes yes yes

Predictive Temperature yes yes yes

Temperature yes no no

Invasive Pressure yes no no

Carbon Dioxide yes no no

Microstream CO

Direct Telemetry Connection yes yes no

ECG Output signal yes no no

LAN networking capability yes no yes*

WLAN networking capability yes no yes*

IntelliVue Instrument Telemetry networking capability yes no no

USB Interface yes no yes

Short Range Radio capability yes yes yes

yes no yes

2 Theory of Operation

Functionality (including optional features) MP5 MP5T MP5SC

Severe Sepsis Screening yes no no

OxyCRG high resolution trend yes no no

Neonatal event review yes no no

Integrated recorder yes yes yes

Drug Calculator yes yes no

Gas monitor support yes no no

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

Connection to an external display yes no yes

Nurse call capability yes no yes

Spot Check yes no yes

Multi-Patient Spot Check no no yes

Early Warning Score yes no yes

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

NOTE

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

System Boundaries

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

System Boundaries

2 Theory of Operation

Measurement connections

Built-in measurement block

Philips Clinical Network (wired LAN)

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

Philips Clinical Network (wireless)

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

Hospital LAN, Internet

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

2 Theory of Operation

Hardware Building Blocks

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

MP5/MP5T/MP5SC Hardware Building Blocks

IntelliVue MP5/MP5T/MP5SC

The MP5/MP5T/MP5SC monitor:

• integrates the display and processing unit into a single package

• uses a 8.4” TFT SVGA color display

• uses the Touchscreen as input device

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

Optional Hardware

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

• optional recorder

• optional battery

• optional MSL board

• optional Short Range Radio (SRR) board

2 Theory of Operation

Power Distribution

Power Distribution Architecture

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

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

2 Theory of Operation

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

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

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

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

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

NOTE

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

System Interfaces

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

System Interface boards:

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

• Battery: LAN, Battery Board, mCO

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

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

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

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

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

#J02

#J43

#J40

Compatible Devices (not for MP5T and MP5SC)

IntelliVue G1/G5 Anesthetic Gas Module

Data Flow

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

2 Theory of Operation

Data Acquisition

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

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

algorithms to analyze the signals.

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

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

Data Flow

2 Theory of Operation

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

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

Data Provider System Service

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

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

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

Persistent Data Storage System Service

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

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

Display and User Interface Service

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

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

Monitor Applications

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

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

Internal LAN (Measurement Link)

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

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

2 Theory of Operation

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

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

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

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

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

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

NOTE

The MP5 does not support any MMS on the MSL.

Microstream CO2

CO2 sample rate: 20 samples/second

Calculation of end tidal CO

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

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

seconds.

Test method for respiration rate range:

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

tidal CO

values beyond those limits.

Philips Clinical Network

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

(etCO2):

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

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

and N2 gases was used to simulate respiration rates

values were compared to the expected value.

values were within the limits of the specified

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

2 Theory of Operation

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

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

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

How does the Support Tool Work with the Monitor

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

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

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

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

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

Monitor Software Block Diagram

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

2 Theory of Operation

IntelliVue Patient Monitoring System Functional Block Diagram

2 Theory of Operation

Block Diagram Legend

Functional Block Description

Services

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

System Services The System Services provide generic common system

Applications

Reports The Reports Service retrieves current and stored physiological

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

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

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

• Vital Signs Report

• Graphical Trend Report

• Event Review Report

• Event Episode Report

• ECG Report (12 Lead/Multi-Lead)

• Test Report

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

Record The Record Service retrieves current and stored physiological

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

2 Theory of Operation

Functional Block Description

Alarm The Alarm Service contains logic that prioritizes alarm

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

Trend The Trend service stores the sample values of physiological

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

OxyCRG The OxyCRG (Oxygen CardioRespiroGram) service derives a

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

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

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

Calc Param The Calc Param (Calculated Parameters) application performs

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

Interface Managers

2 Theory of Operation

Functional Block Description

MDSE The MDSE (Medical Data Service Element) Interface

Printer The Printer Interface Manager provides a high level interface

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

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

to a printer. It provides means to:

• establish a connection to the printer

• transfer data to the printer

• get status of the printer

• close connection to the printer

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

following tasks:

Interfaces

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

• Screen presentation of operating controls (control windows)

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

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

2 Theory of Operation

Functional Block Description

LAN The LAN interface implements the physical layer of IEEE

802.3. The LAN interface performs Manchester encoding/

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

Display Controller The Display Controller Interface consists of a video

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

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

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

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

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

Nurse Call (not for MP5T)

MIB (not for MP5T and MP5SC)

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

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

ECG Sync Out (not for MP5T and MP5SC)

IIT (not for MP5T and MP5SC)

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

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

WLAN (not for MP5T)

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

SRR The built-in SRR interface allows wireless communication of

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

2 Theory of Operation

Functional Block Description

MSL (not for MP5T and MP5SC)

USB Interface (not for MP5T)

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

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

3Testing and Maintenance

Introduction

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

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

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

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

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

Terminology and Definitions

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

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

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

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

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

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

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

3 Testing and Maintenance

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

Recommended Frequency

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

Test s Frequency

Preventive Maintenance

Other Regular Tests

Performance Assurance Tests

NBP Performance Once every two years, or more

often if specified by local laws.

Microstream CO2 Calibration

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

Tympanic Temperature Calibration Once a year. If the unit is

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

Visual Inspection Before each use.

Power On Test

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

ECG Out Sync Performance

ECG Sync Pulse Performance

SpO2 Performance

NBP Performance

Invasive Pressure Performance

Temperature Accuracy

1,2

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

Predictive Temperature Accuracy Check

Mainstream CO2 Accuracy Check

1,2

Sidestream CO2 Accuracy Check and Flow Check

Microstream CO2 Performance Test

Nurse Call Relay Performance

1,2

Power Loss Alarm Buzzer Performance

MSL Assurance Test

1,2

Mounting Integrity Test

Battery Performance

3 Testing and Maintenance

Test s Frequency

Safety Test s

These tests do not apply for MP5T.

These tests do not apply for MP5SC

Visual

Electrical

Visual Inspection After each service event

Protective Earth Once every two years and after

Equipment Leakage Current

Patient Leakage Current

System Test Once every two years

When to Perform Tests

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

Service Event

(When performing...

Installation

Installation of a monitor in combination with a

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

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

Installation of a monitor with a medical display specified by Philips

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

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

Installation of monitor with IntelliVue Instrument Telemetry (IIT)

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

Installation of monitor with IntelliVue 802.11 Bedside Adapter

Installation of a monitor with Short Range Radio (SRR)

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

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

Tests Required

...Complete these tests)

Perform Visual Inspection, Power On and System Tests

Perform Visual Inspection and Power On Test

Perform Visual Inspection, Power On and System Test

Perform Visual Inspection and Power On Tests

Perform Visual Inspection, Power On and IIT communication test

Perform Visual Inspection, Power On and System Tests

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

Perform Visual Inspection, Power On and SRR communication test

3 Testing and Maintenance

Service Event

(When performing...

Tests Required

...Complete these tests)

Preventive Maintenance

Preventive Maintenance* Perform preventive maintenance tests and

procedures:

• NBP calibration

• Microstream CO2 calibration

• Tympanic Temperature Calibration

Other Regular Tests and Tasks

Visual Inspection Perform Visual Inspection

Power On Test Perform Power On test

Repairs

Repairs where the monitor has been damaged by

impact, liquid ingression, fire, short circuit or

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

electrical surge.

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

Perform Visual Inspection, Power On, all Safety

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

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

Performance Assurance Test and NBP Accuracy

Test and Calibration.

Repairs where the measurement block has been removed or replaced

Perform Visual Inspection, Power On, all Safety

Tests and Basic Performance Assurance Test.

If a certain parameter seems suspicious, perform

Full Performance Assurance Test for this

parameter.

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

Tests, Basic Performance Assurance Test and NBP

Performance Test and Calibration

Repairs of IntelliVue Instrument Telemetry (IIT) Module

Perform Visual Inspection, Power On Test Block

and IIT communication test

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

IntelliVue 802.11 Bedside Adapter

Communication Test

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

Communication Test

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

further testing requirements, see IntelliVue G1/

G5 Service Guide

Repairs where the Quick Mount has been

Perform Mounting Integrity Test disassembled

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

Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test

3 Testing and Maintenance

Service Event

(When performing...

Tests Required

...Complete these tests)

Performance Assurance

Basic Performance Assurance Perform basic performance assurance tests for the

respective monitoring system component.

Full Performance Assurance Perform all accuracy and performance test

procedures listed in the following sections. If a

particular measurement is in question, perform the

measurement performance test only.

Upgrades

Software Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades Perform Visual Inspection, Power On Test and

Basic Performance Assurance Test unless

otherwise specified in the Upgrade Installation

Notes shipped with the upgrade.

Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IIT

communication Test

Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and IntelliVue 802.11

Bedside Adapter Communication Test

Hardware Upgrades where Short Range Radio (SRR) is installed

Perform Visual Inspection, Power On Test, Basic

Performance Assurance Test and SRR

communication Test

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

Perform Visual Inspection, Power On Test, Basic

Performance Tests and all Safety Tests need to be removed.

Combining or Exchanging System Components (non-medical equipment

Perform the System Test for the respective system

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

NOTE

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

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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