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*
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 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
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
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
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.
1

1Introduction

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.
8

2Theory 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:
2
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 CO
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
2
yes no
9
2 Theory of Operation
NOTE
The following descriptions may vary depending on the monitor option purchased.
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
10
System Boundaries
The following diagram discusses specific boundaries within the overall system with respect to their openness and real-time requirements:
2 Theory of Operation
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
11
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):
12
Figure 2 MP5 Hardware Building Blocks
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
2 Theory of Operation
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 main- and 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, mCO
Full: LAN, Battery, MIB/RS232, Video, Nurse Call, mCO
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.
#J02
2
#J40
2
14
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.
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.
Figure 5 Data Flow
15
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/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.
17
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.
18
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
Figure 6 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
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:
20
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
21
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)
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 (not for MP5T)
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)
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)
A pulse signal is provided on the RS-232 interface to allow synchronisation with other medical devices.
23
2 Theory of Operation
Functional Block Description
IIT (not for MP5T)
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 and MP5T monitors with an IntelliVue Instrument Telemetry Transceiver.
MSL (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
24

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.
3
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.
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.
Table 1 Table 1: Suggested Testing Timetable
Test s Frequency
Preventive Maintenance
Other Regular Tests
Performance Assurance Test s
Safety Test s
Visual
Electrical
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. Visual Inspection Before each use. Power On Test
ECG/Resp Performance Once every two years, or if you suspect the ECG Out Sync Performance* ECG Sync Pulse Performance* SpO2 Performance NBP Performance 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 Visual Inspection After each service event
Protective Earth Once every two years and after repairs Equipment Leakage Current Patient Leakage Current
System Test Once every two years
measurement is incorrect, except
Mainstream CO2 Accuracy Check,
Sidestream CO2 Accuracy Check and Flow
Check and Predictive Temperature
Accuracy Check - required once a year.
where the power supply has been removed
or replaced or the monitor has been
damaged by impact.
26
* These tests do not apply for MP5T.
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
3 Testing and Maintenance
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
Preventive Maintenance
Preventive Maintenance* Perform preventive maintenance tests and
Tests Required
...Complete these tests)
Perform Visual Inspection, Power On and System Tests
Perform Visual Inspection and Power On Test
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
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
impact, liquid ingression, fire, short circuit or electrical surge.
Perform Visual Inspection, Power On, all Safety Tests and Full Performance Assurance Tests
27
3 Testing and Maintenance
Service Event
(When performing...
Repairs where the power supply, the mains
socket or an interface board is removed or
Tests Required
...Complete these tests)
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 All other IntelliVue Monitoring System repairs
(except when power supply is removed)
Perform Visual Inspection, Power On Test and
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
(When performing...
Hardware Upgrades where IntelliVue Instrument Telemetry (IIT) is installed
Hardware Upgrades where IntelliVue 802.11 Bedside Adapter is installed
Hardware Upgrades where Short Range Radio (SRR) is installed
Installation of Interfaces or Hardware Upgrades where the power supply or parameter boards need to be removed.
Combining or Exchanging System Components (non-medical equipment
connected to an IntelliVue monitor or medical system equipment operated on a multiple socket outlet)
Tests Required
...Complete these tests)
Perform Visual Inspection, Power On Test, Basic
Performance Assurance Test and IIT
communication Test
Perform Visual Inspection, Power On Test, Basic
Performance Assurance Test and IntelliVue 802.11
Bedside Adapter Communication Test
Perform Visual Inspection, Power On Test, Basic
Performance Assurance Test and SRR
communication Test
Perform Visual Inspection, Power On Test, Basic
Performance Tests and all Safety Tests
Perform the System Test for the respective system
components
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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