Philips Intellivue MP5 User manual

Service Manual

IntelliVue Patient Monitors

MP5/MP5T

Rel. G.0

Patient Monitoring

Part Number 4535 641 80621

Printed in Germany 10/09

*4535 641 80621*

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		57
Preventive Maintenance Procedures		68
Performance Assurance Tests		69
Reporting of Test Results		85
Other Regular Tests		89
Touchscreen Calibration		89
Disabling/Enabling Touch Operation		90
Printer Test Report		90
Battery Handling, Maintenance and Good Practices		91
After Installation, Testing or Repair		97
	4 Troubleshooting	99
Introduction		99
How To Use This Section		99
Who Should Perform Repairs		99
Replacement Level Supported		99
Software Revision Check		100
Obtaining Replacement Parts		101
Troubleshooting Guide		101

3

	5 Repair and Disassembly		133
Who Should Perform Repairs		133
Tools required		134
Removing the Handle or Bedhanger		134
Removing the Predictive Temperature Assembly		135
Disassembling the Predictive Temperature Assembly		137
Separating the Front and Back of the Monitor		139
Removing the Recorder Slot Cover		143
Removing the Internal Quick Mount Solution		144
Removing the Short Range Radio (SRR) Interface		144
Removing the IntelliVue 802.11 Bedside Adapter Antenna or IIT Antenna (not for MP5T)146
Removing the IntelliVue 802.11 Bedside Adapter (WLAN) (not for MP5T)		147
Removing the IntelliVue Instrument Telemetry (IIT) Module (not for MP5T)		150
Removing the IntelliVue 802.11 Bedside Adapter/IIT Holder (not for MP5T)		151
Removing the MSL Board (not for MP5T)		152
Removing the Backlight Inverter Board		153
Removing the Power Supply		155
Removing the System Interface Board		156
Removing the Recorder Board		157
Removing the Microstream CO2 Assembly		159
Removing the Measurement Block		165
Removing the NBP Pump		169
Removing the Main Board		171
Removing the Touch Assembly		174
Removing the Loudspeaker		176
Removing the Power Button and LED Assembly		176
Removing the LCD Panel		178
Exchanging the Backlight		179
Modifying the Nurse Call Relay		179
	6 Parts	183
MP5/MP5T Parts		183
External Display Part Numbers (not for MP5T)		196
	7 Installation Instructions	199
Out-Of-Hospital Transport - Standards Compliance		199
Electromagnetic Emissions		201
Electromagnetic Interference (SRR)		201
Installation Checklist		202
Unpacking and Checking the Shipment		202
Installing the Predictive Temperature Probe		204
Mounting the Monitor		205
Connecting the Monitor to AC Mains		210
Checking Out The Monitor		210
Loading Paper		212
Configuration Tasks		213

4

Handing Over the Monitor		216
Installing Remote Devices (not for MP5T)		216
Philips Clinical Network (Wired) (not for MP5T)		218
Philips Clinical Network (Wireless) (not for MP5T)		218
Philips IntelliVue Information Center		219
IntelliVue Instrument Telemetry (IIT)(not for MP5T)		219
Short Range Radio		220
Connecting the MP5 to a Host Monitor (not for MP5T)		222
Nurse Call Relay (not for MP5T)		223
ECG Out Functionality (ECG Sync) (not for MP5T)		223
ECG Sync Pulse (not for MP5T)		224
	8 Site Preparation	225
Introduction		225
Monitor Site Requirements		227
Remote Device Site Requirements		229
Philips Medical LAN		232
RS232/MIB Interface		233
Telemetry Device (Patient Worn Device) cables		233
Nurse Call Relay Interface		234
ECG Out Interface		234
	9 Gas Analyzers (not for MP5T)	235
10 MP5 Product Structure		237
Upgrades		242
11 Default Settings Appendix		245
Country-Specific Default Settings		245
	Index	255

5

6

1

Introduction

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

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

Who Should Use This Guide

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

How to Use This Guide

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

Abbreviations

Abbreviations used throughout this guide are:
Name	Abbreviation
IntelliVue MP5/MP5T Patient Monitor	the monitor
Medical Information Bus	MIB

Responsibility of the Manufacturer

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

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

7

1Introduction

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

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

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

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

Philips Medizin Systeme Böblingen GmbH Hewlett-Packard Str. 2

71034 Böblingen, Germany

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

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

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

Passwords

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

Monitoring Mode: No password required Configuration Mode: 71034

Demo Mode: 14432

Service Mode: 1345

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

Warnings and Cautions

In this guide:

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

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

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2

Theory of Operation

Monitor Theory of Operation

The IntelliVue MP5/MP5T Patient Monitor:

•displays real-time data

•alarms in the case of patient or equipment problems

•offers limited data storage and retrieval (trending)

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

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

Functionality (including optional features)	MP5	MP5T
ECG	yes	no
SpO2	yes	yes
NBP	yes	yes
Predictive Temperature	yes	yes
Temperature	yes	no
Invasive Pressure	yes	no
Carbon Dioxide	yes	no
Microstream CO2	yes	no
Direct Telemetry Connection	yes	yes
ECG Output signal	yes	no
LAN networking capability	yes	no
WLAN networking capability	yes	no
IntelliVue Instrument Telemetry networking capability	yes	no
Short Range Radio capability	yes	yes

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2 Theory of Operation

Functionality (including optional features)	MP5	MP5T
Severe Sepsis Screening	yes	no
OxyCRG high resolution trend	yes	no
Neonatal event review	yes	no
Integrated recorder	yes	yes
Drug Calculator	yes	yes
Gas monitor support	yes	no
Connection to a host monitor (companion mode)	yes	no
Connection to an external display	yes	no
Nurse call capability	yes	no

NOTE

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

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2 Theory of Operation

System Boundaries

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

Figure 1 System Boundaries

Measurement connections

Built-in measurement block

Philips Clinical Network (wired LAN)

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

Philips Clinical Network (wireless)

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

Hospital LAN, Internet

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

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2 Theory of Operation

Hardware Building Blocks

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

Figure 2 MP5 Hardware Building Blocks

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2 Theory of Operation

IntelliVue MP5/MP5T

The MP5/MP5T monitor:

•integrates the display and processing unit into a single package

•uses a 8.4” TFT SVGA color display

•uses the Touchscreen as input device

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

Optional Hardware

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

•optional recorder

•optional battery

•optional MSL board

•optional Short Range Radio (SRR) board

Power Distribution

Figure 3 Power Distribution Architecture

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

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

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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

Note that WLAN, IIT and MSL Interface require the full system interface board. The MP5T is delivered only with the battery system interface board.

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

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2 Theory of Operation

Compatible Devices

Figure 4 IntelliVue G1/G5 Anesthetic Gas Module

Data Flow

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

Figure 5 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.

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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/MP5T communicates as a Multi-Measurement Module (MMS) in companion mode when connected to a host monitor using an IEEE802.3/Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the the MP5/MP5T and the host monitor, for example:

16

2 Theory of Operation

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

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

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

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

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

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

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

NOTE

The MP5/MP5T does not support any MMS on the MSL.

Philips Clinical Network

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

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

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

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

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

How does the Support Tool Work with the Monitor

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

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

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2 Theory of Operation

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

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

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

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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.

Figure 6 IntelliVue Patient Monitoring System Functional Block Diagram

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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.

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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

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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

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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)	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)	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)	synchronisation with other medical devices.

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2 Theory of Operation

Functional Block	Description
IIT	The built-in IIT adapter allows operation of the MP5
(not for MP5T)	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 and MP5T monitors with an IntelliVue Instrument
	Telemetry Transceiver.
MSL	All components of the monitoring system communicate using
(not for MP5T)	an IEEE802.3/ Ethernet LAN in the Measurement Link
	(MSL). This network is used to distribute data between the
	components

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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 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.

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3 Testing and Maintenance

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

Recommended Frequency

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

Table 1 Table 1: Suggested Testing Timetable

	Tests			Frequency
	Preventive Maintenance		NBP Performance	Once every two years, or more often if
				specified by local laws.
			Microstream CO2 Calibration	Once a year or after 4000 hours of
				continuous use and following any
				instrument repairs or the replacement of
				any instrument parts.
	Other Regular Tests		Visual Inspection	Before each use.
			Power On Test
	Performance Assurance		ECG/Resp Performance	Once every two years, or if you suspect the
	Tests		ECG Out Sync Performance*	measurement is incorrect, except
				Mainstream CO2 Accuracy Check,
			ECG Sync Pulse Performance*
				Sidestream CO2 Accuracy Check and Flow
			SpO2 Performance	Check and Predictive Temperature
			NBP Performance	Accuracy Check - required once a year.
			Invasive Pressure Performance*
			Temperature Accuracy*
			Predictive Temperature Accuracy Check
			Mainstream CO2 Accuracy Check*
			Sidestream CO2 Accuracy Check and
			Flow Check*
			Microstream CO2 Performance Test*
			Nurse Call Relay Performance*
			Power Loss Alarm Buzzer Performance
	Safety	Visual	Visual Inspection	After each service event
	Tests
		Electrical	Protective Earth	Once every two years and after repairs
				where the power supply has been removed
			Equipment Leakage Current
				or replaced or the monitor has been
			Patient Leakage Current
				damaged by impact.
			System Test	Once every two years

* These tests do not apply for MP5T.

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3 Testing and Maintenance

When to Perform Tests

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

Table 2 When to perform tests

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
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
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.

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3 Testing and Maintenance

Service Event	Tests Required
(When performing...	...Complete these tests)
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
All other IntelliVue Monitoring System repairs	Perform Visual Inspection, Power On Test and
(except when power supply is removed)	Basic Performance Assurance Test
Performance Assurance
Basic Performance Assurance	Perform basic performance assurance tests for the
	respective monitoring system component.
Full Performance Assurance	Perform all accuracy and performance test
	procedures listed in the following sections. If a
	particular measurement is in question, perform the
	measurement performance test only.
Upgrades
Software Upgrades	Perform Visual Inspection, Power On Test and
	Basic Performance Assurance Test unless
	otherwise specified in the Upgrade Installation
	Notes shipped with the upgrade.
Hardware Upgrades	Perform Visual Inspection, Power On Test and
	Basic Performance Assurance Test unless
	otherwise specified in the Upgrade Installation
	Notes shipped with the upgrade.

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	3 Testing and Maintenance
Service Event	Tests Required
(When performing...	...Complete these tests)
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.

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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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