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IntelliVue MP80/90 & D80
Service Guide
IntelliVue Patient Monitor
MP80/90 & D80
Patient Monitoring
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Part Number M8000-9351K
4535 641 12591
*M8000-9351K*
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Table of Contents
1 Introduction 9
Who Should Use This Guide 9
How to Use This Guide 9
Abbreviations 9
Responsibility of the Manufacturer 10
Passwords 11
Warnings and Cautions 11
2 Theory of Operation 13
Monitor Theory of Operation 13
System Boundaries 14
Hardware Building Blocks 15
Data Flow 19
How does the Support Tool Work with the Monitor 23
Monitor Software Block Diagram 24
Block Diagram Legend 25
3 Testing and Maintenance 33
Introduction 33
Terminology and Definitions 34
Recommended Frequency 35
When to Perform Tests 36
Testing Sequence 40
Visual Inspection 41
Before Each Use 41
After Each Service, Maintenance or Repair Event 41
Power On Test 41
Safety Tests 42
Warnings, Cautions, and Safety Precautions 43
Safety Test Procedures 44
Preventive Maintenance Procedures 84
Noninvasive Blood Pressure Measurement Calibration 84
Performance Assurance Tests 84
Basic Performance Assurance Test 84
Full Performance Assurance Test 85
ECG/Resp Performance Test 85
ECG Sync Performance Test 86
SpO2 Performance Test 86
NBP PerformanceTest 87
Invasive Pressure Performance Test 89
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Temperature Performance Test 90
M3014A Capnography Extension Performance Tests 90
Microstream CO2 Performance Test 93
Spirometry Performance Tests 98
Cardiac Output Performance Test 100
BIS Performance Test 101
Vuelink Performance Test 102
IntelliBridge Performance Test 103
EEG, SvO2 and tcGas Performance Tests 103
Nurse Call Relay Performance Test 103
Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed) 105
IntelliVue 802.11 Bedside Adapter Communication Test 106
Reporting of Test Results 107
Carrying Out and Reporting Tests 108
Evaluation of Test Results 111
Other Regular Tests 112
Touchscreen Calibration 112
Disabling/Enabling Touch Operation 112
Printer Test Report 113
After Installation, Testing or Repair 113
4 Troubleshooting 115
Introduction 115
How To Use This Section 115
Who Should Perform Repairs 115
Replacement Level Supported 116
Hardware Revision Check 116
Hardware/Software Compatibility Matrix 117
Software Revision Check 118
Software Compatibility Matrix 119
Compatibilty with MMS 119
Compatibilty with FMS 120
Compatibility with Information Center 120
Number of Supported Parameter Modules 121
Obtaining Replacement Parts 123
Troubleshooting Guide 123
Checks for Obvious Problems 123
Checks Before Opening the Instrument 124
Troubleshooting Tables 126
Status Log 154
List of Error Codes 156
Troubleshooting with the Support Tool 156
Troubleshooting the Individual Measurements or Applications 157
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5 Repair and Disassembly 159
Tools Required 159
MP80/D80/MP90 CMU Disassembly 159
Removing I/O Boards 160
Removing the Top Cover 162
Removing the Plastic Feet and/or the Locking Cam 163
Removing the optional Fans (MP90 Dual CPU Versions only)* 163
Replacing the Second (Independent) Video Board(MP90 Dual CPU Versions only) 164
Removing the Second CPU/Main Board (MP90 Dual CPU Versions only) 165
Accessing the Main CPU or Primary Video Board (MP90 Dual CPU Versions) 167
Replacing the Primary Video Board 168
Removing the Main Board 170
Removing the Power Supply 172
Removing the Speaker (MP80/MP90 only) 174
Removing the Power On/Off Switch 174
Flexible Module Rack (FMS) Disassembly 175
Removing the Handle and the Measurement Server Mount 175
Plug-in Modules 180
Plug-In Module Disassembly 181
Multi-Measurement Module (MMS) Disassembly 184
Tools required 184
Removing the Front Cover 184
Removing the Mounting Pin 185
Removing the Top Cover 185
Removing the DC/DC Board 186
Removing the MSL Flex Assembly 186
Reassembling the MSL Flex Assembly 187
Removing the NBP pump 189
Refitting the new NBP Pump 189
Refitting the DC/DC board 191
Refitting the Cover 191
Refitting the Front Cover 192
Final Inspection 193
MMS Extensions - Exchanging the Top Cover, MSL Flex Cable and the Dual Link Bar 193
Exchange Procedures 194
Disassembly Procedures for the M3015A MMS Extension (HW Rev. A) 205
Removing the Front Cover 205
Refit Procedures for the MMS Extension 209
6 Parts 211
MP80/MP90/D80 Parts 212
Exchange Parts 212
Replacement Parts 213
Flexible Module Rack (FMS) Parts 216
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Exchange and Replacement Parts 216
Multi-Measurement Module (MMS) Parts 218
MMS Part Number Overview and Identification 218
MMS Firmware Overview 220
MMS Part Numbers - Front Bezel for M3001 #A01 & #A03 221
MMS Part Numbers - Front Bezel for M3001 #A02 221
MMS Part Numbers - Top Cover and MSL Assembly 222
MMS Exchange Part Numbers 223
MMS Part Numbers - Label Kits 225
MMS Part Numbers - NBP Assembly 225
MMS Extension Parts (M3012A, M3014A, M3015A and M3016A) 225
MMS Extension Part Numbers - Release Mechanisms 226
MMS Extension Part Numbers - Top Cover, Flex Cable and Link Bar 226
MMS Extension Part Numbers - Front Bezels 226
Exchange Parts List 228
IntelliVue X2 Part Numbers 229
Plug-in Modules Part Numbers 229
Part Number Table 230
Plug-In Modules Replaceable Parts 233
BIS Solution Replaceable Parts 238
BISx Solution Replacable Parts 239
tcpO2/tcpCO2 Module Accessories 240
IntelliVue 802.11 Bedside Adapter Part Numbers* 241
External Display Part Numbers 241
SpeedPoint Part Numbers 244
Remote Alarm Device Part Numbers 245
Remote Extension Device Part Numbers 245
7 Installation Instructions 247
Installation Checklist 247
Unpacking the Equipment 248
Initial Inspection 248
Mechanical Inspection 248
Electrical Inspection 248
Claims For Damage and Repackaging 249
Installing the M8008A/M8010A/M8016A CMU 249
Mounting Instructions 250
Connecting the Monitor to AC Mains 251
Connections 251
Installing Interface Boards 252
Connection of Devices via the MIB/RS232 Interface G.00.xx or higher 257
Connection of Devices via the MIB/RS232 Interface (Rev. D.00.58 to F.01.42) 258
Connection of Devices via the MIB/RS232 Interface (Rev. A.10.15 to C.00.90) 258
Connection of MIB Devices (Rev. below A.10.15) 259
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Connection of USB Devices 260
Setting Up Multiple Displays 264
Installation of Multiple Displays 264
Configuring Multiple Displays 266
Examples for Multiple Display Use Models 270
Installing Remote Devices 272
Mounting the 15” Remote Display (M8031A) 272
Mounting the 15” Remote Display (M8031B) 273
Mounting the 17” Remote Display (M8033A/B/C) 274
Hardware Settings 277
Flexible Module Rack and/or Multi-Measurement Module 277
Remote Alarm Devices 283
Remote Extension Device 284
PS/2 Keyboard/Mouse 286
Philips Clinical Network (Wired) 286
Philips Clinical Network (Wireless) 286
Nurse Call Relay 287
Connections 287
ECG Out Functionality 287
Connections 287
Configuration Tasks 288
Checking Country-Specific Default Settings 289
Setting Altitude, Line Frequency, ECG Cable Colors and Height & Weight Units 289
Setting Altitude and Line Frequency 290
Configuring the Equipment Label 290
Configuring the printer 290
Configuring IP Address, Subnet Mask and Default Gateway 290
Configuration Settings for CSCN Routed Bedside Monitors (RBM) 291
Configuring Routed Bedside Monitors Support 291
Display Settings 292
IntelliBridge EC10 293
Accessing the IntelliBridge EC10 Service Interface 293
Firmware Upgrade 294
Uploading and Removing Device Drivers 295
Generating and Uploading Clone Files 295
Viewing System Information 296
Handing Over the Monitor 297
8 Site Preparation 299
Introduction 299
Site Planning 299
Roles & Responsibilities 300
M8008A/M8010A/M8016A Site Requirements 302
Space Requirements 302
Environmental Requirements 303
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Electrical and Safety Requirements (Customer or Philips) 303
Remote Device Site Requirements 304
Connecting Non-Medical Devices 305
Multi-Measurement Module (MMS) M3001A, IntelliVue X2 M3002A or Flexible Module Rack (FMS) M8048A305
Remote Displays (M8031A) 310
Remote Displays (M8031B) 311
Remote Displays - M8033A 312
Remote Displays - M8033B 313
Remote Displays - M8033C 314
Remote Alarm Devices 316
Remote Extension Device 317
IntelliBridge 319
Local Printer 319
Philips Medical LAN 319
RS232/MIB/LAN Interface 320
Nurse Call Relay Interface 321
ECG Out Interface 321
9 Gas Analyzers 323
10 Philips 15210B Calibration Unit 325
Unpacking the Instrument 325
Initial Inspection 326
Instrument Identification 326
Specification 326
Operating Environment 327
Operating Information 327
Fitting the Gas Cylinders 327
Storage of Gas Cylinders 327
Disposal of Used Gas Cylinders 327
Routine Maintenance 327
Changing the Gas Cylinders 327
Care and Cleaning 328
Theory of Operation 328
Gas Flow Performance Check 329
Test Procedure 329
Disassembly 331
Parts List 332
11 IntelliVue Product Structure 335
Upgrade Options 337
12 Index 341
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1
1Introduction
This Service Guide contains technical details for the IntelliVue MP80/90 Patient Monitor, the
Multi-Measurement Module (MMS), the IntelliVue X2, the Flexible Module Rack (FMS) and
the Measurement Server Extensions.
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
systems so that engineers who repair them are better able to understand how they work.
It covers the physiological measurements that the products provide, the Measurement Server that
acquires those measurements, and the monitoring system that displays them.
Who Should Use This Guide
This guide is for biomedical engineers or technicians responsible for troubleshooting, repairing,
and maintaining Philips’ patient monitoring systems.
How to Use This Guide
This guide is divided into eight sections. Navigate through the tab le of conte nts 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 MP80/90 Patient Monitor the monitor
Flexible Module Rack FMS
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1 Introduction Responsibility of the Manufacturer
Name Abbreviation
Multi-Measurement Module MMS
Measurement Link MSL
Medical Information Bus MIB
Anesthetic Gas Module AGM
Responsibility of the Manufacturer
Philips only considers itself responsible for any effects on safety, EMC, reliability and
performance of the equipment if:
- assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by Philips, and
- the electrical installation of the relevant room complies with national standards, and
- the instrument is used in accordance with the instructions for use.
To ensure safety and EMC, use only those Philips parts and accessories specified for use with
the monitor. If non-Philips parts are used, Philips is not liable for any damage that these parts
may cause to the equipment.
This document contains proprietary information which is protected by copyright. All Rights
Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited,
except as allowed under the copyright laws.
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Str. 2
71034 Böblingen, Germany
The information contained in this document is subject to change without notice.
Philips makes no warranty of any kind with regard to this material, including, but not limited to,
the implied warranties or merchantability and fitness for a particular purpose.
Philips shall not be liable for errors contained herein or for incidental or consequential damages
in connection with the furnishing, performance, or use of this material.
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Passwords 1 Introduction
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 effecti ve 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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1 Introduction Warnings and Cautions
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2Theory of Operation
Monitor Theory of Operation
The IntelliVue MP80/MP90 Patient Monitor:
- displays real-time data
- controls the attached measurement servers
- alarms in the case of patient or equipment problems
- offers limited data storage and retrieval (trending)
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- interfaces to the Philips Clinical Network and other equipment
A monitor with just a single integrated measurement server can be connected to additional
building blocks to form a monitoring system with a large number of measurements, additional
interface capabilities and multiple slave displays. These elements cooperate as one single
integrated real-time measurement system.
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System Boundaries
The following diagram discusses specific boundaries within the overall system with respect to
their openness and real-time requirements:
Measurement LAN
combines components of one patient monitor; real time requirements
across all interconnect ed elements
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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Monitor Theory of Operation 2 Theory of Operation
Hardware Building Blocks
The following hardware building blocks make up the monitoring system:
IntelliVue MP80/MP90
The MP80/MP90 monitor:
- can be used with the standalone M8031A 15-inch or the M8033A 17-inch color LCD TFT
display with touchscreen operation.
- can also be used with other XGA and SXGA standalone off-the-shelf displays which comply
with medical standards such as IEC 60601-1 and IEC 60601-1-2.
- has the central processing unit in a separate module
- uses the Philips SpeedPoint as primary input device whereas the Philips Touchscreen and
computer devices such as mice, trackball, and keyboard can be added o pti on ally
- supports the Flexible Module Rack (FMS)
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Building Blocks:
Optional Hardware
The M8031A 15-inch color LCD TFT display or the M8033A 17-inch color LCD TFT display
(both with touchscreen operation) can be ordered optionally. Additional input devices such as
mice, trackball or keyboard can also be added. If the monitor is ordered with the wireless LAN
option a wireless transmitter is required. For further details regarding the wireless network please
refer to the M3185A Philips Clinical Network documentation.
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Compatible Devices
M3001A Multi-Measurement Module (MMS)
M3002A IntelliVue X2
M3012A, M3014A, M3015A, M3016A MMS Extensions
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Power Supply
The AC/DC converter transforms the AC power coming from the power plug into 48 V/120W
DC source and isolates the monitoring system from the AC power mains.The 48V is distributed
via power bus and supplies power to all the components of the system: The 56 V DC power
needed for the FMS, MMS and MMS Extension is created by an isolating DC/DC converter.
The CPU is supplied with 3.3 V and 5 V DC power. The transformation is performed in two
steps: The first DC/DC converter is a power regulator which reduces the variations caused by
load changes on the 48V power bus. The second DC/DC converter converts the power to the
needed voltage. Interface boards require a power of 10V AC.
CPU Boards
The CPU boards have an MPC860 50 MHz or MPC86x 100 MHz processor that provides a
number of on-chip, configurable interfaces. An array of 12 fast UARTS with configurable
protocol options are implemented in an ASIC (along with other system functions such as
independent watchdogs etc.), providing interfacing capabilities to measurement modules and I/O
boards. The serial interfaces can easily be electrically isolated. The main board contains
additional video hardware.
The CPUs provide two LAN interfaces to interconnect CPUs (via the MSL) and to connect to the
Philips Clinical Network.
The CPU capabilities are identical. Different loading options are coded on serial EEPROMs to
support the automatic configuration of the operating system at boot time.
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I/O Boards
Interfaces to the monitor are implemented via I/O boards. The location of these boards is
restricted by general rules. The I/O slot designations diagram and the I/O matrix which outline
the I/O board placement rules can be found in the Installation Instructions section.
The following is a list of Interface (I/O) boards which may be present in your monitor,
depending on your purchased configuration:
- MSL
- Video (analog)
- Philips Clinical Network (LAN wired or wireless)
- Basic Alarm Relay (Nurse Call)
I/O boards:
- PS/2
- MIB/RS232
- USB
Data Flow
- Flexible Nurse Call
- Parallel printer
- Remote devices (Remote Alarm Device, Remote Extension Device)
- IntelliVue 802.11 Bedside Adapter
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.
The following diagram shows how data is passed through the monitoring system. The individual
stages of data flow are explained below.
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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 Servers
The Measurement Servers connected to the internal LAN 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 parameter modules and the
Anesthetic Gas Module.
- 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 measurement servers 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
temorarily 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.
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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 ASIC.
User input is acquired from a variety of input devices, for example the SpeedPoint, the
touchscreen or other standard input devices (keyboard, mouse) which may be attached to I/O
boards. The system software makes sure that the user input is directed to the application which
has the operating focus.
Data Output
The monitoring system is very flexible and customizable regarding its data output devices.
Built-in devices (for example LAN, alarm lamps, speaker, video) provide the basic output
capabilities.
These capabilities can be enhanced by adding additional I/O boards, as required in the specific
end-user setup. The additional I/O boards typically provide data to externally attached devices,
for example to printers, RS232 based data collection devices, nurse call systems etc.
The monitor can identify I/O boards by means of a serial EEPROM device that stores type and
version information. The operating system detects the I/O boards and automatically connects
them with the associated (interface driver) application. For some multi-purpose cards it is
necessary to configure the card for a particular purpose first (for example the dual MIB/RS232
card can support external touch display , data import, data export).
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.
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Internal LAN (Measurement Link)
All components of the monitoring system (including measurement servers and CPUs in the
monitor) communicate using an IEEE802.3/ Ethernet LAN in the Measurement Link (MSL).
This network is used to distribute data between the components, for example:
- Digitized patient signals including wave data, numerical data and status information
(typically from the measurement server to a display unit)
- Control data representing user interactions (typically from the display unit to a measurement
server)
- Shared data structures, for example representing patient demographical data and global
configuration items
The internal LAN allows plug and play configuration of the monitoring system. The system
automatically detects plugging or unplugging of measurement servers and configures the system
accordingly.
The components on the internal LAN are time-synchronized to keep signal data consistent in the
system. Dedicated hardware support for synchronization eliminates any latency of the network
driver software.
The integrated LAN provides deterministic bandwidth allocation/reservation mechanisms so that
the real-time characteristic of signal data and control data exchange is guaranteed. This applies
to the data flow from the 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 and the FMS allow flexible cabling options (star
topology, daisy chaining of servers).
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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 external wireless adapter or an internal wireless
adapter (#J35). Switching between wired and wireless networks is automatically triggered by the
plugging or unplugging of the network cable.
The Philips Clinical Network protocols function very similarly to the protocols used on the
internal LAN.
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 componen ts
(modules, measurement servers, and monitors) 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.
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Monitor Software Block Diagram
shows the functional block diagram for the monitoring system. A legend explaining terms and
diagram elements follows. The information below varies depending on the purchased monitor
options.
IntelliVue Patient Monitoring System Functional Block Diagram
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Block Diagram Legend
Functional Block Description
Services
Operating System The Operating System (OS) provides a layer of isolation
between the specific hardware implem entati on an d 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 Servers, Flexible Module Racks
and IntelliVue Patient Monitoring System software
modules. User configuration data is stored in a
non-volatile read/write storage device
Applications
Application Server Client The Application Server Client provides the Citrix1 thin
client functionality.
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Functional Block Description
Reports The Reports Service retrieves current and stored
physiological data and status data to format reports for
printing paper documentation. The following reports are
supported:
- Vital Signs Report
- Graphical Trend Report
- Event Review Report
- Event Episode Report
- ECG Report (12 Lead/Multi-Lead)
- Cardiac Output Report
- Calculations Report
(Hemodynamic/Oxygenation/Ventilation)
- Calculations Review Report
- Wedge Report
- Test Report
- Other reports (e.g. Loops, Review Applications, Drug
report)
The Reports service generates report data which can be
printed on a local or 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 an M1116B Recorder in the FMS. The Record
Service can also send data to a central recorder.
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Functional Block Description
Alarm The Alarm Service contains logic that prioritizes alarm
conditions that are generated either by the Measurement
Servers, Flexible Module Rack, or 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.
HiRes The OxyCRG (Oxygen CardioRespiroGram) service
derives a high-resolution trend graph from the
Beat-to-Beat Heart Rate, SpO2 or tcpO2, and Respiration
physiological data. The OxyCRG is specialized for
neonatal applications, allowing the operator to identify
sudden drops in Heart Rate (Bradycardia) and SpO2 or
tcpO2 (Desaturations), 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. The ADT service also
supports the transport of a patient (trend database) with
the M3001A Multi-Measurement Module. The ADT
service controls the deletion of old patient data, the
upload of trend data from the M3001A and the switching
back of all settings to user defaults. It also synchronizes
patient information with a central station on the network.
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Functional Block Description
Calc Param The Calc Param (Calculated Parameters) service accesses
current, stored and manually entered physiological data as
input to calculation formulas. With these formulas,
derived hemodynamic, oxygenation and ventilation
variables are computed. The calculation results, including
the input parameters, are stored for later review using the
Trend service.
Drug Calc The Drug Calc application aids in calculating drug
dosages for patients.
PV Loops The PV Loops application compares graphic
representations of airway waves to help detect changes in
the patient airway condition.
Interface Managers
MDSE The MDSE (Medical Data Service Element) Interface
Manager is responsible for the exchange of real-time data
between the IntelliVue Patient Monitoring System display
unit and the Measurement Servers and Flexible Module
Rack as well as between the IntelliVue Patient
Monitoring System display unit 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.
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Monitor Theory of Operation 2 Theory of Operation
Functional Block Description
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, Measurement
Servers or Flexible Module Rack
- Sound generation (issues audible alarm signals and
generates audible information signals, for example
QRS and SpO2 tones, operator audible feedback)
Interfaces
LAN The LAN interface implements the physical layer of IEEE
802.3. The LAN interface performs Manchester
encoding/decoding, receive clock recovery, transmit pulse
shaping, jabber, link integrity testing, reverse polarity
detection/correction, electrical isolation, and ESD
protection. Electronically separated interfaces are used for
communication to the Measurement Servers or Flexible
Module Rack and to the network.
Centronics The Centronics interface implements the standard
signaling method for bi-directional parallel peripheral
devices according to IEEE 1284-I. The interface is used
as a parallel interface to a standard printer with electrical
isolation and ESD protection.
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2 Theory of Operation Monitor Theory of Operation
Functional Block Description
Display Controller The Display Controller Interface consists of a video
controller chip, 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, Speed Point, USB and PS/2 devices), 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
waveform directly from the ECG/Resp Arrhythmia
ST-Segment physiological algorithm via an RS-422 serial
interface and converts the digital ECG signal to an analog
ECG signal. In addition, the ECG Out controller 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
RS-422 The serial link RS-422 interface communicates the ECG
signal to the ECG Output/Marker In of the IntelliVue
Patient Monitoring System display unit. The interface is a
serial, differential, full-duplex link. The interface is ESD
protected.
PS/2 The PS/2 interface supports the serial protocol of standard
PS/2 devices (mouse). The PS/2 serial protocol is
interpreted by the HIF Control interface.
Nurse Call The Nurse Call board contains 2 connectors. A phone
jack type connector and a multi-port connector. The
phone jack type connector has a single close-on-alarm
relay. The multi-port connector has three alarm relays
which are configurable to be open or closed on alarm. In
addition, this interface has an audible alert capability for
loss of AC power.
MIB The MIB interface allows full-duplex, short-haul
asynchronous binary communication between the monitor
and an arbitrary (medical/non-medical) device using an
eight-pin RJ45 modular connector. Switching between
MIB and RS232 protocol is possible.
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Monitor Theory of Operation 2 Theory of Operation
Functional Block Description
USB Interface The USB interface allows connection of USB devices
(Mouse, Keyboard, Barcode Scanner, Printer) to the
monitor.
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2 Theory of Operation Monitor Theory of Operation
32 33
Page 33
3Testing and Maintenance
Introduction
This chapter provides a checklist of the testing and maintenance procedures to ensure the
performance and safety of the monitor, the Multi-Measurement Module (MMS),the MMS
Extensions and the Flexible Module Rack (FMS) associated modules.
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.
3
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.
Page 34
3 Testing and Maintenance Terminology and Definitions
Terminology and Definitions
The following terms and definitions are used throughout this chapter and taken from the
international standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.
- Medical System: a medical electrical system is a combination of at least one medical
electrical device and other electrical equipment, interconnected by functional connection or
use of a multiple portable socket-outlet.
- Patient Vicinity: any area in which intentional or unintentional contact can occur between
the patient and parts of the medical system or between the patient and other persons who
have had contact with parts of the medical system. The patient vicinity is defined anywhere
within 1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.
- Separation Device/Transformer: a component or arrangement of components with input
parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or
current between parts of a medical system.
- Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to
be connected to or integrated with flexible cables or cords, which can easily be moved from
one place to another while connected to the power mains.
- Functional Connection: an electrical connection for transfer of signals and/or power.
- Tests: Safety or Performance Assurance test procedures which may consist of several steps.
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Recommended Frequency 3 Testing and Maintenance
Recommended Frequency
Perform the procedures as indicated in the suggested testing timetable. These timetable
recommendations do not supersede local requirements.
Tests Frequency
Preventive Maintenance*
Table 1: Suggested Testing Timetable
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
Performance Assurance
Tests
Visual Inspection
Power On Test
ECG/Resp Performance
ECG Sync Pulse Performance
SpO2 Performance
NBP Performance
Invasive Pressure Performance
Temperature Accuracy
M3014A Capnography Extension
Performance Tests
Microstream CO2 Performance Test
Spirometry Accuracy Test
C.O. Performance
BIS Performance
VueLink Performance
IntelliBridge Performance Test
Before each use.
Once every two years, or if you suspect
the measurement is incorrect, except
Mainstream CO2 Accuracy Check,
Sidestream CO2 Accuracy Check and
Flow Check - required once a year.
Safety
Tests
35
Visual
Electrical
Nurse Call Relay Performance
Visual Inspection After each service event
Protective Earth
Equipment Leakage Current
Patient Leakage Current
Once every two years and after repairs
where the power supply has been
removed or replaced or the monitor has
been damaged by impact.
System Test Once every two years
Page 36
3 Testing and Maintenance When to Perform Tests
*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the CO2
pump/CO
scrubber replacement procedure. This is required every three years or after 15000
2
operating hours.
NOTE
The EEG, SvO2 and tcGas parameters do not require performance testing. See EEG, SvO2
and tcGas Performance Tests (on page
103) for details.
When to Perform Tests
This table tells you when to perform specific tests.The corresponding test procedures are
described in the following sections All tests listed below must be performed on the monitor
itself, any attached MMS/X2 and FMS incl. parameter modules.
When to perform tests
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 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 IEC 60601-1)
Installation of a monitor with AGM or
IntelliVue G1/G5, connected to separate
mains sockets.
Installation of a monitor with a Vuelink
connection to another medical device
(compliant with IEC 60601-1), connected to
separate mains sockets.
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 and Power On Tests
Installation of a monitor with an
Perform Visual Inspection and Power On Tests
IntelliBridge connection to another medical
device (compliant with IEC 60601-1),
connected to separate mains sockets.
Installation of a monitor with IT equipment
e.g. printer, PC connected via a functional
Perform Visual Inspection, Power On and
System Tests
connection e.g. Centronics or USB.
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When to Perform Tests 3 Testing and Maintenance
Service Event
(When performing...
Installation of monitor with IntelliVue
802.11 Bedside Adapter
Tests Required
...Complete these tests)
Perform Visual Inspection, Power On and
IntelliVue 802.11 Bedside Adapter
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, FMS, parameter
modules, MMS or X2 have been damaged by
impact, liquid ingression, fire, short circuit or
electrical surge.
Repairs where the power supply, the mains
socket or an interface board is removed or
replaced or the protective earth ground
connection is disrupted.
Repairs of IntelliVue 802.11 Bedside
Adapter
Repairs of the parameter modules, FMS,
MMS or X2 (all service events where the
parameter modules, FMS, MMS or X2 have
been opened)
Repairs where the NBP pump of the MMS or
X2 has been replaced
Perform Visual Inspection, Power On, all
Safety Tests and Full Performance Assurance
Tests
Perform Visual Inspection, Power On, all
Safety Tests and Basic Performance Assurance
Test
Perform Visual Inspection, Power On and
IntelliVue 802.11 Bedside Adapter
Communication Test
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.
Perform Visual Inspection, Power On, all
Safety Tests, Basic Performance Assurance
Test and NBP Performance Test and
Calibration
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3 Testing and Maintenance When to Perform Tests
Service Event
(When performing...
Tests Required
...Complete these tests)
Repairs of the AGM or IntelliVue G1/G5 Perform Basic Performance Assurance Test.
For further testing requirements, see AGM or
IntelliVue G1/G5 Service Guide
Repairs where the parameter module, MMS
or X2 has been replaced.
Repairs where the printer connected via
Centronics or USB I/O board has been
Perform Visual Inspection, Power On and
Basic Performance Assurance
Perform Visual Inspection, Power On, System
Test and Printer Test.
replaced.
All other IntelliVue Monitoring System
repairs (except when power supply is
Perform Visual Inspection, Power On Test and
Basic Performance Assurance Test
removed)
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 802.11
Bedside Adapter is installed
Perform Visual Inspection, Power On Test,
Basic Performance Assurance Test and
IntelliVue 802.11 Bedside Adapter
Communication Test
Installation of Interfaces or Hardware
Upgrades where the power supply or
Perform Visual Inspection, Power On Test,
Basic Performance Tests and all Safety Tests
parameter boards need to be removed.
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When to Perform Tests 3 Testing and Maintenance
NOTE
Service Event
(When performing...
Combining or Exchanging System
Components
Tests Required
...Complete these tests)
Perform the System Test for the respective
system components
*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the pump and
scrubber replacement procedures.
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
Testing Sequence
Summary of the recommended sequence of testing:
Start
Select the test
Visual Inspection
Safety Tests
Performance Tests
Reporting of Results
Evaluation of Results
See When to Perform Tests (on page
36)
See Visual Test (see "
page
41).
Before Each Use" on
See Safety Test Procedures (on page
44).
See Performance Assurance Tests (on page
84).
See Reporting of Test Results (on page
107)
See Evaluation of Test Results (on page
111)
NOTE
Check and prepare for normal use
If any single test fails, testing must be discontinued immediately and the device under test must
be repaired or labeled as defective.
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Visual Inspection 3 Testing and Maintenance
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 external ly .
- any damage or contamination, internally and externally
- that no loose parts or foreign bodies remain in the device after servicing or repair.
- the integrity of all relevant accessories.
Power On Test
1. Connect the monitoring system to mains and switch it on. This includes connected displays,
2. Make sure that all steps listed in the table Initial Instrument Boot Phase in the
The expected test result is pass: the monitor boots up and displays an ECG wave. The wave
might be a flat line if no simulator is attached.
MMS, MMS Extensions, X2, FMS and FMS associated modules, gas analyzers and Vuelink
devices.
Troubleshooting section are completed successfully and that an ECG wave appears on the
screen.
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3 Testing and Maintenance Safety Tests
Safety Tests
Safety tests are comprised of the following tests performed on the monitoring system:
- protective earth resistance
- equipment leakage current
- applied part leakage current
- system test (if required)
Safety test requirements are set according to international standards, their national deviations and
specific local requirements. The safety tests detailed in this Service Guide are derived from
international standards but may not be sufficient to meet local requirements. We recommend that
you file the results of safety tests. This may help to identify a problem early particularly if the
test results deteriorate over a period of time.
Each individual piece of equipment of the monitoring system which has its own connection to
mains or which can be connected or disconnected from mains without the use of a tool must be
tested individually. The monitoring system as a whole must be tested according to the System
Test (on page
69) procedure.
Accessories of the monitoring system which can affect the safety of the equipment under test or
the results of the safety test must be included in the tests and documented.
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Safety Tests 3 Testing and Maintenance
Warnings, Cautions, and Safety Precautions
- These tests are well established procedures of detecting abnormalities that, if undetected,
could result in danger to either the patient or the operator.
- Disconnect the device under test from the patient before performing safety tests.
- Disconnect the device under test from mains before performing safety tests. If this is not
possible, ensure that the performance of these tests does not result in danger to the safety
analyzer operator, patients or other individuals.
- Test equipment (for example, a Safety Analyzer) is required to perform the safety tests.
Please refer to Annex C of IEC/EN 62353 for exact requirements for the measurement
equipment and for measurement circuits for protective earth resistance and leakage currents.
Refer to the documentation that accompanies the test equipment. Only certified technicians
should perform safety testing.
- The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step to maintain user and patient safety. You can also use the
Safety Analyzer as a troubleshooting tool to detect abnormalities of line voltage and
grounding plus total current loads.
- During safety testing, mains voltage and electrical currents are applied to the device under
test. Ensure that there are no open electrical conductive parts during the performance of
these tests. Avoid that users, patients or other individuals come into contact with touch
voltage.
- For Europe and Asia/Pacific, the monitor complies with:
IEC60601-1:1988 + A1:1991 + A2:1995 = EN60601-1:1990 +A1:1993 + A2:1995
IEC60601-1-1:2000
For USA, the monitor complies with:
UL60601-1
For Canada, CAN/CSA C22.2#601.1-M90
- Local regulations supersede the testing requirements listed in this chapter.
- If a non-medical electrical device is connected to a medical electrical device, the resulting
medical electrical system must comply with IEC/EN 60601-1-1.
- Perform safety tests as described on the following pages.
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3 Testing and Maintenance Safety Tests
Safety Test Procedures
Use the test procedures outlined here only for verifying safe installation or service of the
product. The setups used for these tests and the acceptable ranges of values are derived from
local and international standards but may not be equivalent. These tests are not a substitute for
local safety testing where it is required for an installation or a service event. If using an approved
safety tester, perform the tests in accordance with the information provided by the manufacturer
of the tester and in accordance with your local regulations, for example IEC/EN 60601-1,
UL60601-1 (US), IEC/EN 62353, and IEC/EN 60601-1-1. The safety tester should print results
as detailed in this chapter, tog ether with other data.
Please refer to Annex C of IEC/EN 62353 for requirements for the measurement equipment and
for measurement circuits for protective earth resistance and leakage currents.
The following symbols are used in the diagrams illustrating the safety tests:
CAUTION
Supply mains
Protective earth
L, N Supply mains terminals PE Protective earth terminal
Mains part
F-type applied part
Applied part
Measuring device
Resistance measuring
device
......... Optional connection
Connection to accessible
conductive parts
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 external ly .
- any damage or contamination, internally and externally.
- that no loose parts or foreign bodies remain in the device after servicing or repair.
- the integrity of all relevant accessories.
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Safety Tests 3 Testing and Maintenance
Hints for Correct Performance of Safety Tests
- Perform a visual inspection on all detachable power cords used with the monitoring system
and include these in all safety test procedures.
- Connection lines such as data lines or functional earth conductors may appear to act like
protective earth connections. These may lead to incorrect measurements and need to be
considered during testing. If necessary, unplug these connections.
- Position all cables and cords in such a manner that they do not influence the safety tests.
- Measurement of insulation resistance is not required.
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3 Testing and Maintenance Safety Tests
Guideline for Performance of Safety Tests
Connect the detachable power cord of the device under test to the safety analyzer's test mains
port. Connect the enclosure test lead of the safety analyzer to the enclosure of the device under
test, e.g. to the equipotential connector. For testing the applied part leakage current, connect all
applied parts to the safety analyzer using the appropriate patient lead or adapter cable. For the
ECG parameter all ten ECG-leads need to be connected to the safety analyzer. If necessary, use
an adapter cable to connect all ten ECG-leads. If necessary, repeat the safety test procedure until
all available applied parts have been tested. Refer to the documentation that accompanies the
safety analyzer for further details on how to set up and perform the test.
Protective Earth Resistance Test - Setup Example
Equipment Leakage Current Test - Setup Example
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Safety Tests 3 Testing and Maintenance
Applied Part Current Test - Setup Example
NOTE
The above graphics resemble the Metron QA-90 setup and are protected by copyright. Copyright
owned by Fluke (Metron).
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3 Testing and Maintenance Safety Tests
Safety Test Adapter Cable - Schematics
The following graphics provide schematics of safety test (patient lead) adapter cables which can
be used for electrical safety testing. These schematics can also be used as a guideline for making
your own safety test adapter cables. Alternatively, other methods to make safety test adapter
cables can be used, e.g. using a modified accessory cable.
NOTE
You may not need all of the cables displayed below for electrical safety testing of your
respective monitor.
ECG:
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Safety Tests 3 Testing and Maintenance
SpO2 (MP2/X2, MP5, M3001A & M1020B #A01, #A02, #A03):
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3 Testing and Maintenance Safety Tests
SpO2 (M1020A):
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Safety Tests 3 Testing and Maintenance
Invasive Pressure:
M1006B #C01:
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3 Testing and Maintenance Safety Tests
Temperature:
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Safety Tests 3 Testing and Maintenance
CO2 (MP5, M3014A):
53
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3 Testing and Maintenance Safety Tests
CO2 (M1016A, M3016A):
4 = all resistors 120 KOhm
54
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Safety Tests 3 Testing and Maintenance
Cardiac Output:
55
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3 Testing and Maintenance Safety Tests
BIS:
Use Clamp Adapter Cable and M1034-61650 BIS sensor simulator.
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Safety Tests 3 Testing and Maintenance
VueLink:
4 = 220 Ohm
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3 Testing and Maintenance Safety Tests
IntelliBridge:
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Safety Tests 3 Testing and Maintenance
EEG:
59
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3 Testing and Maintenance Safety Tests
SvO2 (M1021A):
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Safety Tests 3 Testing and Maintenance
ScvO2 (M1011A):
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3 Testing and Maintenance Safety Tests
tcpO2/tcpCO2:
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Safety Tests 3 Testing and Maintenance
MP5 predicitive Temperature:
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3 Testing and Maintenance Safety Tests
MP5 TAAP:
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Safety Tests 3 Testing and Maintenance
S(1): Protective Earth Resistance Test
Test to perform:
Measuring circuit for the measurement of Protective Earth Resistance in medical electrical
equipment that is disconnected from the supply mains.
NOTE
This measures the impedance of the Protective Earth (PE) terminal to all exposed metal parts of
the Instrument under Test (IUT), which are for safety reasons connected to the Protective Earth
(PE).
Measurements shall be performed using a measuring device capable to deliver a current of at
least 200 mA into 500 mOhms with maximum 24V
This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003
and CSA 601.1-M90.
For measurement limits, refer to Safety (1) test, Test and Inspection Matrix.
Report the highest value (X1).
Test Expected test results
Protective Earth Resistance Test (with
X1 <= 300mOhms
mains cable)
- If the protective earth resistance test fails, testing must be discontinued immediately and the
device under test must be repaired or labeled as defective.
- All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise
stated.
- Flex the power cord during the protective earth resistance test to evaluate its integrity. If it
does not pass the test, exchange the power cord.
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3 Testing and Maintenance Safety Tests
S(2): Equipment Leakage Current Test - Normal Condition
Test to perform:
Measuring circuit for the measurement of Equipment Leakage Current - Direct method
according to IEC/EN 62353.
NOTE
This test measures leakage current of exposed metal parts of the monitor and the functional earth
leakage current. It tests normal and reversed polarity. Perform the test with S1 closed (Normal
Condition).
There are no parts of the equipment that are not protectively earthed.
This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003
and CSA 601.1-M90.
For measurement limits, refer to Safety (2) test, Test and Inspection Matrix.
Report the highest value (X1).
Test Expected test results
Equipment Leakage Current Test
X1 <= 100μA
(Normal Condition - with mains
cable)
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise
stated.
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Safety Tests 3 Testing and Maintenance
S(3): Equipment Leakage Current Test - Single Fault Condition
Test to perform:
Measuring circuit for the measurement of Equipment Leakage Current - Direct method
according to IEC/EN 62353.
This test measures leakage current of exposed metal parts of the monitor and the functional earth
leakage current. It tests normal and reversed polarity. Perform the test with S1 open (Single Fault
Condition).
NOTE
There are no parts of the equipment that are not protectively earthed.
This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003
and CSA 601.1-M90.
For measurement limits, refer to Safety (3) test, Test and Inspection Matrix.
Report the highest value (X2).
Test Expected test results
Equipment Leakage Current Test
X2 <= 300μA
(Single Fault Condition - with mains
cable)
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise
stated.
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3 Testing and Maintenance Safety Tests
S(4): Applied Part Leakage Current - Mains on Applied Part
NOTE
During measurement of the Applied Part Leakage Current it is possible that the measured current
can exceed the allowed limit (per IEC/EN 60601-1 or IEC/EN 62353).
This can occur when the safety tester is connected to the invasive blood pressure and
temperature connectors at the same time during the applied leakage current measurement.
The connectors for the invasive blood pressure and temperature are independently functioning
connectors.
Although there are individual connectors on the front end, internally those parameters use the
same electrical insulation interface and are hardwired to each other. This results in an electrical
short of those connectors during measurement if a test current is applied simultaneously .
Therefore this should be avoided.
Due to the combined insulation interface, it is sufficient to connect to only one parameter
interface (that is, Invasive Blood Pressure or Temperature) of the invas ive bl ood
pressure/temperature measurement block. This avoids a short and the potential of exceeding the
limit for the current.
Test to perform:
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Safety Tests 3 Testing and Maintenance
Measuring circuit for the measurement of Applied Part Leakage Current - Direct method
according to IEC/EN 62353.
This test measures applied part leakage current from applied part to earth caused by external
main voltage on the applied part. Each polarity combination possible shall be tested. This test is
applicable for ECG measurement inputs.
There are no parts of the equipment that are not protectively earthed.
This safety test is based on IEC/EN 60601-1, IEC/EN 62353, UL2601-1 Ed. 2/UL60601-1:2003
and CSA 601.1-M90.
For measurement limits and test voltage, refer to Safety (4) test, Test and Inspection Matrix.
Report the highest value. (X1).
Test Expected test results
Applied Part Leakage Current Test
S4 <= 50μA
(Single Fault Condition - mains on
applied part)
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise
stated.
System Test
After mounting and setting up a system, perform system safety tests according to IEC/EN
60601-1-1.
What is a Medical Electrical System?
A medical electrical system is a combination of at least one medical electrical piece of
equipment and other electrical equipment, interconnected by functional connection or use of a
multiple portable socket-outlet.
- Devices forming a medical electrical system must comply with IEC/EN 60601-1-1.
- Any electrical device such as IT equipment that is connected to the medical electrical
equipment must comply with IEC/EN 60601-1-1 and be tested accordingly.
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General Requirements for a System
After installation or subsequent modification, a system must comply with the requirements of the
system standard IEC/EN 60601-1-1. Compliance is checked by inspection, testing or analysis, as
specified in the IEC/EN 60601-1-1 or in this book.
Medical electrical equipment must comply with the requirements of the general standard IEC/EN
60601-1, its relevant particular standards and specific national deviations. Non-medical electrical
equipment shall comply with IEC safety standards that are relevant to that equipment.
Relevant standards for some non-medical electrical equipment may have limits for equipment
leakage currents higher than required by the standard IEC/EN 60601-1-1. These higher limits are
acceptable only outside the patient environment. It is essential to reduce equipment leakage
currents to values specified in IEC 60601-1 when non-medical electrical equipment is to be used
within the patient environment.
System Example
This illustration shows a system where both the medical electrical equipment and the
non-medical electrical equipment are situated at the patient’s bedside.
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WARNING
- Do not use additional AC mains extension cords or multiple portable socket-outlets. If a
multiple portable socket-outlet is used, the resulting system must be compliant with IEC/EN
60601-1-1. Do not place multiple socket-outlets on the floor. Do not exceed the maximum
permitted load for multiple socket-outlets used with the system. Do not plug additional
multiple socket outlets or extension cords into multiple socket outlets or extension cords
used within the medical electrical system.
- Do not connect any devices that are not supported as part of a system.
- Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1. The
whole installation, including devices outside of the patient vicinity, must comply with
IEC/EN 60601-1-1. Any non-medical device placed and operated in the patient’s vicinity
must be powered via a separating transformer (compliant with IEC/EN 60601-1-1) that
ensures mechanical fixing of the power cords and covering of any unused power outlets.
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System Installation Requirements
- Ensure that the the medical electrical system is installed in a way that the user achieves
optimal use.
- Make sure the user is informed about the required cleaning, adjustment, sterilization and
disinfection procedures listed in the Instructions for Use.
- The medical electrical system must be installed in such a way that the user is able to carry
out the necessary cleaning, adjustment, sterilization and disinfection procedures listed in the
Instructions for Use.
- Ensure that the medical electrical system is installed in a way that an interruption and
restoration of power to any part of the medical electrical system does not result in a safety
hazard.
- We recommend using fixed mains socket outlets to power the medical system or parts
thereof. Avoid using multiple portable socket-outlets.
- Any multiple portable socket outlets used must be compliant with IEC 60884-1 and IEC
60601-1-1.
- Ensure that any part of the system connected to multiple portable socket-outlets is only
removable with a tool, i.e. the multiple portable socket-outlet provides a locking mechanism
to prevent power cords from being plugged or unplugged unintentionally. Otherwise, the
multiple portable socket-outlet must be connected to a separation device. Multiple Socket
Outlets used within the medical electrical system must only be used for powering medical
electrical equipment which is part of the system.
- Ensure that any functional connections between parts of the medical electrical system are
isolated by a separation device according to IEC 60601-1-1 to limit increased equipment
leakage currents caused by current flow through the signal connections. This only works if
the equipment leakage current of the respective medical electrical system parts is not
exceeded under normal conditions.
- Avoid increase of equipment leakage currents when non-medical electrical equipment within
the medical electrical system is used. This only works if the equipment leakage current of
the respective medical electrical system parts is not exceeded under normal conditions. Use
additional protective earth connection, separation device or additional non-conductive
enclosures.
- Within the patient environment it is important to limit electrical potential differences
between different parts of a system. If necessary, use potential equalization equipment
(equipotential cable) or additional protective earth connections.
- Medical electrical equipment used in medical rooms must be connected to potential
equalization equipment (equipotential cable) to avoid electrical potential differences. Check
your local requirements for details.
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Required Protective Measures at System Installation
For any IT equipment (IEC60950) operated in patient vicinity ensure that the equipment leakage
current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure
compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current
test is required.
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Case 1: Medical Device Combined with Medical Device
If you combine a medical device with another medical device (incl. Philips specified displays) to
form a medical electrical system according to IEC60601-1-1, no additional protective measures
are required. The medical electrical devices may be located in or outside the patient vicinity in a
medically used room. This is valid as long as the medical devices are connected to separate
mains outlets. No system test is required.
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If the combined medical devices are connected to the same multiple portable socket outlet an
enclosure leakage current test of the entire device combination on the multiple portable socket
outlet is required to ensure that the resulting protect ive earth leakage current and equipment
leakage current does not exceed the limits of IEC 60601-1-1. Avoid using multiple portable
socket outlets. The medical electrical devices may be located in or outside the patient vicinity in
a medically used room. If the limits are exceeded, additional protective measures are required,
e.g. a separation device or the connection of each device to separate mains.
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Case 2: Medical Device Combined with a Non-Medical Device
If you combine a medical device with a non-medical device to form a medical electrical system
according to IEC60601-1-1, additional protective measures are required, e.g. usage of a
separation device. The medical electrical devices or the IT equipment may be located in or
outside the patient vicinity in a medically used room. After system installation incl. protective
measures, a system test is required to ensure that the resulting equipment leakage current and
applied part leakage current does not exceed the limits of IEC 60601-1-1.
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For any IT equipment (IEC60950) operated in patient vicinity ensure that the equipment leakage
current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure
compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current
test is required.
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If the combined devices forming the medical electrical system are connected to the same
multiple portable socket outlet, ensure that the resulting protective earth leakage current and
equipment leakage current do not exceed the limits of IEC 60601-1-1. The medical electrical
devices or IT equipment may be located in or outside the patient vicinity in a medically used
room. Avoid using multiple portable socket outlets. If the limits of IEC 60601-1-1 are exceeded,
additional protective measures are required, e.g. a separation device or the connection of each
device to separate mains.
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For any IT equipment (IEC60950) operated in patient vicinity ensure that the equipment leakage
current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure
compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current
test is required.
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Case 3: Medical Device Combined with a Medical or Non-Medical Device with one Device in a Non-Medically-Used Room
If you combine a medical device with a medical or non-medical device to form a medical
electrical system according to IEC60601-1-1 using a common protective earth connection and
one of the devices is located in a non-medically used room, additional protective measures are
required, e.g. usage of a separation device or additional protective eart h connec tion. The medical
electrical devices or IT equipment may be located in or outside the patient vicinity. After system
installation incl. protective measures, a system test is required to ensure that the resulting
equipment leakage current does not exceed the limits of IEC 60601-1-1.
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If you combine a medical device with a medical or non-medical device to form a medical
electrical system according to IEC60601-1-1 using two separate protective earth connections and
one of the devices is located in a non-medically used room creating a potential voltage
difference, additional protective measures are required, e.g. usage of a separation device or
additional protective earth connection. The medical electrical devices or IT equipment may be
located in or outside the patient vicinity. After system installation incl. protective measures, a
system test is required to ensure that the resulting equipment leakage current does not exceed the
limits of IEC 60601-1-1.
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System Test Procedure
If the medical electrical device has already been tested as a standalone device e.g. during factory
safety testing, an equipment leakage current test must only be performed once the device is
connected to the LAN network. If the medical electrical system has not been tested as a
standalone device, the device has to be tested as a standalone device (without connection to the
system) and as part of the system (with connection to the system).
Connect the detachable power cord of the device under test to the safety analyzer's test mains
port. Connect the enclosure test lead of the safety analyzer to the enclosure of the device under
test, e.g. to the equipotential connector. Refer to the documentation that accompanies the safety
analyzer for further details on how to set up the test.
Test Expected test results
Equipment Leakage Current Test
(Normal Condition)
Equipment Leakage Current Test
(Single Fault Condition)
Sys1 <= 100μA
Sys2 <= 300μA
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After the testing of the device as a standalone device and as part of the system, check that the
resulting values (without connection and with connection to the system) do not differ by more
than +/- 10% from each other.
If the devices in the medical electrical system are connected to a multiple portable socket outlet
the resulting protective earth leakage current needs to be determined. All system components
must be connected to the multiple portable socket outlet and be switched on during this
measurement.
Test Expected test results
Protective Earth Leakage Current of
Sys3 <= 300μA
Multiple Socket Outlets
Refer to the documentation that accompanies the safety analy z er for further detai ls on how to s et
up the test.
Preventive Maintenance Procedures
Noninvasive Blood Pressure Measurement Calibration
Carry out the noninvasive blood pressure measurement performance tests at least every two
years , or as specified by local laws (whichever comes first).
Performance Assurance Tests
Some of the following test procedures must be performed in service mode. To enter service
mode select Operating Modes in the main menu. Then select Service Mode and enter the
password.
If required, open the screen menu in the monitor info line at the top of the screen and select
Service to access the service screen. This is required particularly for Anesthetic Gas Module
testing procedures.
Basic Performance Assurance Test
This section describes the basic performance test procedure. Please refer to the section When to
Perform Tests (on page
Procedure:
36) for detailed information on when which test procedure is required.
Power on the monitoring system and go into demo mode. Check that each connected parameter
(integrated, module, MMS, Gas Analyzer, Vuelink connected device) displays values.
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Full Performance Assurance Test
The following sections describe the full performance testing procedures i.e. detailed testing of
each parameter with a patient simulator or specified tools. Please refer to the section When to
perform Tests (on page
36) for information on when which testing procedure is required.
ECG/Resp Performance Test
This test checks the performance of the ECG and respiration measurements.
Tools required: Patient simulator.
ECG Performance
1. Connect the patient simulator to the ECG/Resp connector.
2. Configure the patient simulator as follows:
- ECG sinus rhythm.
- HR = 100 bpm or 120 bpm (depending on your patient simulator).
3. Check the displayed ECG wave and HR value against the simulator configuration.
4. The value should be 100bpm or 120 bpm+/- 2 bpm.
Respiration Performance
1. Change the Patient Simulator configuration to:
- Base impedance line 1500 Ohm.
- Delta impedance 0.5 Ohm.
- Respiration rate 40 rpm or 45 rpm.
2. The value should be 40 rpm +/- 2 rpm or 45 rpm +/- 2 rpm.
Test Expected test results
ECG Performance Test 100bpm +/- 2bpm or
Respiration Performance Test 40 rpm +/- 2 rpm or
120bpm +/- 2bpm
45 rpm +/- 2 rpm
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ECG Sync Performance Test
This test checks the performance of ECG synchronization between the monitor and a
defibrillator. It only needs to be performed when this feature is in use as a protocol at the
customer site.
Tools required:
- Defibrillator with ECG Sync and Marker Output.
- Patient simulator.
1. Connect the patient simulator to the ECG connector and the defibrillator to the ECG Sync
Output on the monitor.
2. Set the patient simulator to the following configuration:
- HR = 100 bpm or 120 bpm (depending on your patient simulator).
- ECG sinus rhythm.
3. Switch the defibrillator to simulation mode.
4. Check that the marker pulse is displayed before the T-wave begins.
Test Expected test results
ECG Sync Performance Test Marker pulse is displayed before
SpO2 Performance Test
This test checks the performance of the SpO2 measurement.
Tools required: none
1. Connect an adult SpO2 transducer to the SpO2 connector.
2. Measure the SpO
3. The value should be between 95% and 100%.
Test Expected test results
SpO2 Performance Test 95% and 100%
the T-wave begins
value on your finger (this assumes that you are healthy).
2
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Measurement Validation
The SpO2 accuracy has been validated in human studies against arterial blood sample reference
measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with
saturation levels between 70% and 100% SaO2 were studied. The population characteristics for
those studies were:
- about 50% female and 50% male subjects
- age range: 18 to 45
- skin tone: from light to black
NOTE
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. However,
it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration
curve that has been independently demonstrated to fulfill a particular accuracy specification.
NBP PerformanceTest
This section describes NBP test procedures.The monitor must be in service mode and the screen
“Service A” must be selected to perform these tests. The NBP Performance Test consists of:
- NBP Accuracy Test
- NBP Leakage Test
- NBP Linearity Test
- Valve Test
NBP Accuracy Test
This test checks the performance of the non-invasive blood pressure measurement. Connect the
equipment as shown:
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Tools required:
- Reference manometer (includes hand pump and valve), accuracy 0.2% of reading.
- Expansion chamber (volume 250 ml +/- 10%)
- Appropriate tubing.
In service mode, the systolic and diastolic readings indicate the noise of NBP channels 1 and 2
respectively. When static pressure is applied, the reading in NBP channel 1 should be below 50.
The value in parentheses indicates the actual pressure applied to the system.
1. Connect the manometer and the pump with tubing to the NBP connector on the MMS and to
the expansion chamber.
2. In service mode, select the Setup NBP menu.
3. Select Close Valves: On
4. Raise the pressure to 280 mmHg with the manometer pump.
5. Wait 10 seconds for the measurement to stabilize.
6. Compare the manometer values with the displayed values.
7. Document the value displayed by the monitor (x1).
8. If the difference between the manometer and displayed values is greater than 3 mmHg,
9. To calibrate the MMS, select Close Valves off then Calibrate NBP and wait for the
10. Press Confirm.
If the INOP NBP Equipment Malfunction message occurs in monitoring mode, go back to
service mode and repeat the calibration procedure.
NBP Leakage Test
The NBP leakage test checks the integrity of the system and of the valve. It is required once
every two years and when you repair the monitor or replace parts.
1. If you have calibrated, repeat steps 2 to 6 from the accuracy test procedure so that you have
calibrate the MMS. If not, proceed to the leakage test.
instrument to pump up the expansion chamber.Wait a few seconds after pumping stops until
EnterPrVal is highlighted and then move the cursor to the value shown on the
manometer. If one of the following prompt messages appears during this step, check
whether there is leakage in the setup:
- NBP unable to calibrate–cannot adjust pressure
- NBP unable to calibrate–unstable signal
280 mmHg pressure on the expansion chamber.
2. Watch the pressure value for 60 seconds.
3. Calculate and document the leakage test value (x2).
x2 = P1 - P2
where P1 is the pressure at the beginning of the leakage test and P2 is the pressure displayed
after 60 seconds.
The leakage test value should be less than 6 mmHg.
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NBP Linearity Test
1. Reduce the manometer pressure to 150 mmHg.
2. Wait 10 seconds for the measurement to stabilize.
3. After these 10 seconds, compare the manometer value with the displayed value.
4. Document the value displayed by the monitor (x3)
5. If the difference is greater than 3 mmHg, calibrate the MMS (see steps 9 to 10 in the
accuracy test procedure).
Valve Test
1. Raise the pressure again to 280 mmHg.
2. Select Close valves: Off.
3. Wait five seconds and then document the value displayed. The value should be less than 10
mmHg.
4. Document the value displayed by the monitor (x4).
Expected Test Results for NBP Accuracy Test, Leakage Test, Linearity Test & Valve Test
Test Expected test results
Accuracy test x1 = value displayed by monitor
Difference ≤ 3mmHg
Leakage test x2 = leakage test value
x2 < 6 mmHg
Linearity test x3 = value displayed by monitor
Difference ≤ 3mmHg
Valve Test x4 = value < 10 mmHg
Invasive Pressure Performance Test
This test checks the performance of the invasive pressure measurement.
Tools required: Patient simulator.
1. Connect the patient simulator to the pressure connector.
2. Set the patient simulator to 0 pressure.
3. Make a zero calibration.
4. Configure the patient simulator as P(static) = 200 mmHg.
5. Wait for the display.
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6. The value should be 200 mmHg ± 5 mmHg. If the value is outside these tolerances, calibrate
the Invasive Pressure measurement. If the measurement was calibrated with a dedicated
reusable catheter, check the calibration together with this catheter.
Table 4:
Test Expected test results
Invasive Pressure Performance Test 200 mmHg ± 5 mmHg
Temperature Performance Test
This test checks the performance of the temperature measurement.
Tools required: Patient simulator (with 0.1°C or 0.2°F).
1. Connect the patient simulator to the temperature connector.
2. Configure the patient simulator to 40°C or 100°F.
3. The value should be 40°C ± 0.2°C or 100°F ± 0.4°F.
Table 2:
Test Expected test results
Temperature Performance Test 40°C ± 0.2°C or 100°F ± 0.4°F
M3014A Capnography Extension Performance Tests
The procedures below describe the mainstream and sidestream CO2 performance tests for the
M3014A Capnography Extension.
Mainstream CO2 Accuracy Check
Tools Required:
- three airway adapters
- Verification Gas M2506A
- Gas cylinder regulator M2505A
You also need a local barometric pressure rating received from a reliable local source (airport,
regional weather station or hospital weather station) which is located at the same altitude as the
hospital.
Procedure:
1. Attach the M2501A CO
sensor to the patient monitor. Attach an airway adapter to the
2
sensor. Make sure that the sensor is disconnected from the patient circuit.
2. Switch on the patient monitor.
3. Enter the monitor’s Service Mode.
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4. Using the sensor status provided in the M2501A Serial protocol, wait for the M2501A
sensor to warm up to its operating temperature.
5. The default setting for gas temperature is 22°C. If the gas temperature is significantly above
or below this value, correct the gas temperature setting.
6. Zero the sensor on the airway adapter being used in this test. Ensure Zero Gas is set to Room
Air
7. Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the airway adapter.
8. Set the gas correction to off.
9. Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The
expected value is 5% of the ambient pressure ±2mmHg
NOTE
Make sure that you follow the above steps correctly. If the sensor fails this check it must be
exchanged. The sensor cannot be calibrated.
Example for an expected test result:
The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient
pressure is:
Table 6:
Test Expected test results (x1) Acceptance Range
Mainstream CO2 Accuracy
Test
NOTE
The expected test results will differ depending on the conditions (i.e. altitude or ambient
pressure).
Sidestream CO2 Accuracy Check
Tools Required:
- Cal gas flow regulator M2267A
- Cal tube 13907A
- Verification Gas M2506A
- Straight Sample Line M2776A
You also need a local barometric pressure rating received from a reliable local source (airport,
regional weather station or hospital weather station) which is located at the same altitude as the
hospital.
Procedure:
5% of 760 mmHg pressure ±2mmHg
36 mmHg 40 mmHg
1. Attach the M2741A CO2 sensor to the patient monitor. Attach the sample line and the cal
tube to the sensor. Make sure that the sensor is disconnected from the patient circuit.
2. Switch on the patient monitor.
3. Enter the monitor’s Service Mode.
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4. Using the sensor status provided in the M2741A Serial protocol, wait for the M2741A
sensor to warm up to its operating temperature.
5. Zero the sensor. Ensure Zero Gas is set to Room Air
6. Attach a regulated flowing gas mixture of 5% CO2, balance N2 to the cal tube.
7. Set the gas correction to off.
8. Allow a few seconds for the gas mixture to stabilize and observe the CO2 value. The
expected value is 5% of the ambient pressure ±2mmHg
NOTE
Make sure that you follow the above steps correctly. If the sensor fails this check it must be
exchanged. The sensor cannot be calibrated
Example for an expected test result:
The expected test result for an altitude of 0 m (sea level) at approximately 760 mmHg ambient
pressure is:
Test Expected test results (x2) Acceptance Range
Sidestream CO2 Accuracy
Test
5% of 760 mmHg pressure ±2mmHg
36 mmHg 40 mmHg
NOTE
The expected test results will differ depending on the conditions (i.e. altitude or ambient
pressure).
Sidestream CO2 Flow Check
Check the flow rate in the Sidestream CO2 extension as follows:
1. Connect the flowmeter to the sample line
2. Check on the flowmeter the flow that the Sidestream CO2 extension pump draws. It should
be 50 ml/min ± 10 ml/min. If the value is not within tolerance check your setup again and
perform another flow check. If it fails again, the sensor must be replaced. The sensor cannot
be calibrated.
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Microstream CO2 Performance Test
Allow five seconds between individual service procedures to ensure stable equipment conditions.
When certain monitor procedures are running, service procedures are not possible and trying to
start them will result in a message Service Operation Failed in the monitor’s status line.
Wait until the monitor completes the current operation, then restart the service procedure.
This test checks the performance of the Microstream CO2 measurement. The Microstream CO2
measurement can either be integrated into the IntelliVue MP5 monitor or, for other IntelliVue
monitors, into the M3015A MMS Extension. The Microstream CO2 performance test is required
once per year and when the instrument is repaired or when parts are replaced.
This test uses calibration equipment that you can order (see the Parts section for the part
number). The procedure is summarized in the following steps. Refer to the documentation
accompanying the equipment for detailed instructions.
Tools Required:
- Standard tools, such as screwdriver, tweezers
- Electronic flowmeter, M1026-60144
- Gas calibration equipment:
- Cal 1 gas 15210-64010 (5% CO
- Cal 2 gas 15210-64020 (10% CO
)
2
)
2
- Cal gas flow regulator M2267A
- Cal tube 13907A
- Calibration Line M3015-47301
You also need a local barometric pressure rating received from a reliable local source (airport,
regional weather station or hospital weather station) which is located at the same altitude as the
hospital.
The CO2 calibration for the Microstream extension consists of the following steps:
- Leakage check
- Barometric pressure check and calibration, if required.
- Pump check
- Flow check and calibration, if required
- Noise check
- CO2 Cal check and calibration, if required
- CO2 Cal verification using 2nd cal gas
Perform all checks in the same session.
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Leakage Check
The leakage check consists of checking the tubing between:
- the pump outlet and the mCO
outlet and
2
- the pump inlet and FilterLine inlet.
Check the user’s guide of the flowmeter for details on how to make a correct flow reading.
Part 1
1. Go into service mode and select Setup CO2 menu.
2. Connect a FilterLine to the Microstream CO
input to start the pump running.
2
3. Check the ambient pressure and the cell pressure shown in the monitor’s status line. The cell
pressure should be approximately 20 mmHg lower than ambient pressure.
4. Connect the flowmeter outlet to the FilterLine inlet using a flexible connecting tube.
5. Block the mCO
outlet using your fingertip and observe the flowmeter display. The value on
2
the flowmeter (x1) should decrease to between 0 and 4 ml/min, accompanied by an audible
increase in pump noise. If the value is within the tolerance limits, continue with part 2 of the
leakage check.
6. If the value is outside the tolerance limits, there is a leakage between the pump outlet and the
mCO
outlet.
2
7. Open the MMS Extension or MP5 and check the tubing connections at the pump outlet and
the extension gas outlet. If the connections are good, then there is a leakage in the tubing and
you must exchange the MMS Extension or the mCO
Assembly of the MP5 respectively.
2
Part 2
1. Disconnect the flowmeter from the Part 1 setup and connect the flowmeter inlet to the
M3015A gas outlet or the MP5 mCO
2. Leave the Filterline connected to the M3015A inlet or the MP5 mCO
gas outlet.
2
inlet..
2
3. Block the inlet of the FilterLine using your fingertip and observe the flowmeter display. The
value on the flowmeter (x2) should decrease to between 0 and 4 ml/min, accompanied by an
audible increase in pump noise. The cell pressure shown in the status line on the display
should decrease to between 300 and 500 mmHg. Do not block the inlet for longer than 25
seconds as this will lead to an “Occlusion” INOP. If the value is within the tolerance limits,
there are no leakages and the leakage check is completed; proceed to the pump check.
4. If the value is not within the tolerance limits, there is a leakage between the FilterLine inlet
and the pump inlet.
5. Check the FilterLine connections and open the M3015A or MP5 to check the tubing
connections at the pump inlet and the M3015A or MP5 mCO
gas inlet. If the connections
2
are good, try replacing the FilterLine and repeating the leakage check. If the situation
remains, there is a leakage in the tubing and the M3015A or the mCO
must be exchanged.
assembly of the MP5
2
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Barometric Pressure Check and Calibration
Check the barometric pressure value in the M3015A MMS Extension or the MP5 as follows:
Pump Check
1. Go into service mode and select Setup CO
2. Connect a FilterLine to the Microstream CO
menu.
2
input. This activates the pump in the M3015A
2
MMS Extension or the MP5.
3. The status line at the bottom of the screen displays “CO
pressure reading (ambient/cell)
2
xxx/yyy” where xxx is the ambient pressure and yyy is the measured cell pressure. Check
whether the ambient pressure value (x3) matches (within the acceptable tolerance of ±12mm
Hg) the reference value you have received. If so, proceed to the leakage check. If the value
is not correct, calibrate as follows.
a. Select CO
then select Barom.Press to activate a table of values.
2
b. Select the value in the table which matches the reference value received from a reliable local
source (airport, regional weather station or hospital weather station). (The values are
displayed with a resolution of 2 mmHg up to 500 mmHg and a resolution of 1 mmHg from
500 mmHg to 825 mmHg.) Note: the selected value must be within ±10% of the current
measured ambient pressure, otherwise an error message will occur at restarting the monitor.
c. Confirm the barometric pressure setting.
d. Check that the ambient pressure displayed in the status line at the bottom of the screen is the
same as the value which you selected from the list in step b.
1. Connect the flowmeter inlet to the mCO
gas outlet.
2
2. Connect the FilterLine to the mCO
3. Block the inlet of the FilterLine using your fingertip and observe the cell pressure on the
monitor display. The cell pressure (x4) should be more than 120 mmHg below the ambient
pressure shown. If the pressure difference is less than 120 mmHg, the pump is not strong
enough and you should replace it, irrespective of the Pump OpTime.
Flow Rate Check and Calibration
Check the flow rate in the M3015A MMS Extension or the MP5 as follows:
1. Connect the flowmeter to the CO
2. Check on the flowmeter the flow that the M3015A MMS Extension or MP5 mCO2 pum p
draws (x5). It should be 50 ml/min ± 7.5 ml/min. If the value is within tolerance, proceed to
the CO
Gas calibration check. If the value is not within tolerance, calibrate as follows.
2
3. Adjust the flow in the instrument by selecting Increase Flow or Decrease Flow until
it is as close as possible to 50 ml per minute as indicated on the flowmeter gauge.
4. When you are satisfied that the flow is set as close as possible to 50 ml per minute, select
Store Flow and confirm the setting. If you do not store the adjusted flow within 60
seconds of the adjustment, the old flow setting is restored.
inlet.
2
FilterLine.
2
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3 Testing and Maintenance Performance Assurance Tests
5. If you cannot adjust the flow to within tolerance, replace the pump . If you still cannot make
the flow adjustment, this indicates a fault in the measurement extension, which must be
replaced.
Note that the pump can only be replaced on M3015A with the old hardware Rev. A (i.e.
Serial No. DE020xxxxx
Noise Check
1. With the monitor in service mode, select Setup CO
2. Disconnect the flowmeter and connect the 5% calibration gas and flow regulator in its place.
3. Open the valve to apply the 5% calibration gas and wait until the value is stable.
4. Check the noise index (x6) displayed next to the CO
level of noise on the CO
extension.
wave). If the value exceeds 3 mmHg, replace the measurement
2
CO2 Gas Measurement Calibration Check
After switching the measurement extension on, wait at least 20 minutes before checking the
calibration. Check the calibration of the CO
1. Check that the 5% calibration gas and flow regulator are connected.
2. Calculate the expected measurement value in mmHg as follows:
0.05 x (ambient pressure) = value mmHg
for example 0.05 x 736 = 36.8 mmHg (with an ambient pressure of 736 mmHg)
3. Open the valve on the flow regul ator to allow 5% CO
the value to stabilize.
4. Check that the value on the instrument (measurement value on the main screen, x7) matches
the calculated mmHg value ± 2.6 mmHg. If the value is outside the tolerance, calibrate as
described in step in this procedure onwards.
menu.
2
value on the display (this indicates the
2
gas measurement as follows:
2
gas to flow into the extension. Allow
2
5. Disconnect the 5% calibration gas and connect the 10% calibration gas.
6. Calculate the expected measurement value and tolerance in mmHg as follows:
0.1 x (ambient pressure) = value mmHg
±0.07 x (value mmHg) = tolerance
for example 0.1 x 737 mmHg = 73.7 mmHg (with an ambient pressure of 737 mmHg)
±0.07 x 73.7 mmHg = ±5.16 mmHg tolerance
7. Open the valve on the flow regulator to allow 10% CO
gas to flow into the extension.
2
Allow the value to stabilize.
8. Check that the value on the instrument (x8) matches the calculated mmHg value within the
calculated tolerance. If so, the measurement extension is correctly calibrated. If the value is
outside the tolerance, calibrate as follows.
9. If not already connected, connect the 5% calibration gas.
10. Select Cal. CO
.
2
11. Select the value for the calibration gas. (The default value is 5.0%.)
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Performance Assurance Tests 3 Testing and Maintenance
12. Open the valve on the calibration gas to allow CO2 gas to flow into the extension. Allow the
value to stabilize before the start of the calibration. Leave the valve open until the instrument
gives a prompt that gas can be removed.
13. The extension calibrates and prompts when calibration is successful.
Calibration Verification
1. Reopen the 5% gas valve and allow the value to stabilize.
2. Check that the value displayed on the monitor is correct within the tolerance (see step
above).
3. Disconnect the 5% calibration gas and connect the 10% calibration gas.
4. Open the valve on the flow regulator to allow 10% CO2 gas to flow into the extension.
Allow the value to stabilize.
5. Check that the value displayed on the monitor is correct within the tolerance (see step
above).
If one or both values are not within tolerances, you must exchange the M3015A MMS Extension
or the MP5 mCO
Assembly.
2
Test Expected Test Results
Leakage Check
parts 1 and 2
x1 = value of part 1 leakage check on flowmeter
(x1< 4.0 ml/min)
x2 = value of part 2 leakage check on flowmeter
(x2< 4.0 ml/min)
Barometric
Pressure Check
x3 = difference between the reference pressure and the
measured ambient pressure displayed on the monitor
(x3<12 mmHg)
Pump Check x4 = difference in pressure between cell pressure and
ambient pressure displayed on the monitor during
occlusion (x4 >120 mmHg)
Flow Check x5 = difference between measured value and 50.0
ml/min (x5<7.5 ml/min)
Noise Check x6 = noise index displayed on monitor (x6<3.0)
CO2 Gas
Calibration Check
x7 = difference between measured CO2 value and
calculated value, based on 5% CO
cal. gas. (x7 < 2.6
2
mmHg)
CO2 Cal
Verification
x8 = difference between measured CO2 value and
calculated value, based on 10% CO
cal. gas.
2
(x8 < ± {0.07 x value calculated})
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Reset Time Counters
NOTE
This procedure only applies to M3015A with the old hardware Rev. A (i.e. Serial No.
DE020xxxxx
You must check the time counters on the Microstream CO
instrument. As well, when parts are replaced, the appropriate counters must be reset to zero.
The counters for CO
pump, IR Src and Last Cal are displayed in the status line. The values are
2
updated when entering the Setup CO2 menu.
Observe the following guidelines:
- When calibrating the CO
extension, if no parts have been replaced, check the displayed
2
values of Reset PumpOpTime and Reset IRSourceTime selections to make sure that
they are within suggested guidelines for use (15, 000 hours of continuous use). If the counter
time is greater than 15, 000 hours, replace the appropriate part. See Repair and Disassembly
for details.
- When calibrating the CO
extension, if parts have been replaced, reset the appropriate values
2
using the Reset PumpOpTime and Reset IRSourceTime selections. See Repair and
Disassembly for details.
Resetting the PumpOpTime generate s the INOP: “CO
must perform a flow check and store the flow in service mode (select Store Flow).
CO2 Pump / CO2 Scrubber Replacement
NOTE
This procedure only applies to M3015A with the old hardware Rev. A (i.e. Serial No.
DE020xxxxx
extension before calibrating the
2
OCCLUSION”. To clear this INOP you
2
Refer to the Repair and Disassembly section for the replacement procedures.
Spirometry Performance Tests
These tests verify the performance accuracy of the M1014A Spirometry module.
Equipment Required
- Leak test kit (Part number: M1014-64100)
- calibrated barometer
- M2785A Pediatric/Adult Flow Sensor
- 500ml calibration syringe, Hans Rudolph model 5550 or equivalent
Flow Test
1. Connect the M1014A Spirometry Module to the host monitor and go into service mode.
2. Connect the flow sensor to the module.
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Performance Assurance Tests 3 Testing and Maintenance
3. Connect the 500ml calibration syringe to the flow sensor. Make sure the syringe is set to the
“empty” position.
4. Press the Setup key on the module and select Show all Values in the Setup
Spirometry menu.
5. Pump the calibration syringe back and forth with a steady motion at a rate of 20 cycles and
verify that the readings for TVexp and TVin are 500 ± 25 ml.
If the readings are not within the specified range, try another flow sensor. Ensure that the syringe
is calibrated correctly and that the procedure is performed exactly as described above. If the test
fails again, replace the module.
Test Expected test results
Flow Test
TVexp and TVin are 500 ± 25 ml
Leakage Test
1. Connect the M1014A Spirometry Module to the host monitor and go into service mode.
2. Connect the leak test adapter to the module.
3. Press the Setup key on the module and then select Show all Values in the Setup
4. Press the Purge key on the module and start a purge cycle. At the end of the purge cycle, the
5. Verify that the pressure difference between Ppeak and Paw remains less than 10 cmH2O
If the readings are not within the specified range or if an INOP (e.g. SPIRO PURGE FAILED) is
issued, check the leak test adapter for any leaks. Disconn ect the adapter from the module and
start the test procedure from the beginning. If the test fails again, replace the module.
Test Expected test results
Leakage Test Paw and Ppeak >100 cmH2O
Barometer Check
1. Connect the M1014A Spirometry Module to the host monitor and go into service mode.
2. Attach any airway adapter to the module.
Spirometry menu.
values for Paw and Ppeak should both be above 100 cmH2O.
after 30 seconds.
3. Press the Setup key on the module and then select Show all Values in the Setup
Spirometry menu.
4. Check that the barometric reading (PB) is within ± 5 mmHg of a reference barometer.
5. If the readings are not within the specified range, check the accuracy of the barometric
pressure reference again. If the test fails again, replace the module.
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3 Testing and Maintenance Performance Assurance Tests
Test Expected test results
Barometer Check
PB is within ± 5 mmHg of a
reference barometer
NOTE
The built-in barometer cannot be recalibrated.
Cardiac Output Performance Test
These tests check the performance of the cardiac output measurement.
1. Connect the patient simulator to the C.O. module using the patie nt cab le.
2. Configure the patient simulator as follows:
Injection temperature: 2 °C
Computation Const: 0.542
(Edward's Catheter)
Flow: 5 l/min
3. Check displayed value against the simulator configuratio n.
4. Expected test result: C.O. = 5 +/– 1 l/min.
Test Expected test results
Cardiac Output Performance Test C.O. = 5 +/– 1 l/min
Service Tool Procedure, Version 1
This procedure applies for Service Tool M1012-61601 in combination with C.O. modules
without option C10 and M3012A MMS extensions with option C05.
1. In monitoring mode, connect the C.O. interface cable to the module.
2. Connect one side of the service tool to the injectate receptacle of C.O. interface cable and
the other side to catheter cable receptacle.
3. Enter the C.O. Procedure window and check the results. The expected test result is:
o
Tblood = 37.0
C +/- 0.1oC
Test Expected test results
Cardiac Output Service Tool
Procedure Version 1
Tblood = 37.0oC +/- 0.1oC
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