IntelliVue MP20/30
Service Guide
IntelliVue Patient Monitor
MP20/MP20Junior/MP30
Patient Monitoring
Part Number M8001-9301F
453564112561
*M8001-9301F*
Contents
1 Introduction 9
Who Should Use This Guide 9
How to Use This Guide 9
Abbreviations 10
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 21
How does the Support Tool Work with the Monitor 24
Monitor Software Block Diagram 25
Block Diagram Legend 26
3 Testing and Maintenance 33
Introduction 33
Terminology and Definitions 34
Recommended Frequency 34
When to Perform Tests 35
Testing Sequence 39
Visual Inspection 40
Before Each Use 40
After Each Service, Maintenance or Repair Event 40
Power On Test 40
Safety Tests 41
Warnings, Cautions, and Safety Precautions 42
Safety Test Procedures 43
System Test 51
What is a Medical Electrical System? 51
General Requirements for a System 52
System Example 52
System Installation Requirements 54
Required Protective Measures at System Installation 55
System Test Procedure 65
Preventive Maintenance Procedures 66
Noninvasive Blood Pressure Measurement Calibration 66
Microstream CO2 Calibration 66
Performance Assurance Tests 66
3
Basic Performance Assurance Test 67
Full Performance Assurance Test 67
ECG/Resp Performance Test 67
ECG Sync Performance Test 68
SpO2 Performance Test 68
NBP PerformanceTest 69
Invasive Pressure Performance Test 71
Temperature Performance Test 72
M3014A Capnography Extension Performance Tests 72
Microstream CO2 Performance Test 75
Nurse Call Relay Performance Test 80
Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed) 82
Docking Station Performance Test 82
IIT Communication Test 83
IntelliVue 802.11 Bedside Adapter Communication Test 83
Reporting of Test Results 85
Carrying Out and Reporting Tests 85
Evaluation of Test Results 88
Other Regular Tests 89
Touchscreen Calibration 89
Disabling/Enabling Touch Operation 90
Printer Test Report 91
Battery Handling, Maintenance and Good Practices 91
About the Battery 92
Checking the Battery Status 93
Battery Status on the Main Screen 94
Battery Status Window 97
Conditioning a Battery 98
Conditioning Batteries 99
After Installation, Testing or Repair 100
4 Troubleshooting 101
Introduction 101
How To Use This Section 101
Who Should Perform Repairs 101
Replacement Level Supported 102
Software Revision Check 102
Obtaining Replacement Parts 102
Troubleshooting Guide 102
Checks for Obvious Problems 103
Checks Before Opening the Instrument 103
Troubleshooting Tables 105
Status Log 134
List of Error Codes 135
Troubleshooting with the Support Tool 136
4
Troubleshooting the Individual Measurements or Applications 136
5 Repair and Disassembly 137
Tools required 137
How to find the Correct Procedure 138
Removing Directly Accessible Parts 139
1.1 Removing the Handle 140
1.2 Removing the Measurement Server Holder 140
1.3 Removing the I/O Boards and Interface Board 142
1.4 Removing the Recorder 143
1.5 Removing the Navigation Point Knob 143
1.6 Removing the Quick Release Mount and Knob 144
1.7 Removing the Fix Mount 144
2.0 Opening the Front of the Monitor 146
2.1 Removing the Backlight Tubes 147
2.2 Removing the Backlight Inverter Board 148
2.3 Removing Power On LED board and Silicon Pad 149
2.4 Removing the HIF Board, Silicon Pad and Spacer 150
2.5 Removing the Flex Adapter Cable 151
2.6 Removing the Battery Board 152
2.7 Removing Recorder Board Assembly 153
2.8 Removing the Loudspeaker 154
2.9 Removing the Branding Cover 155
3.0 Separating the Front and Back Half of the Monitor 155
3.1 Removing the LCD Flat Panel Display, Touch Panel and Front Housing 156
3.2 Removing the Main Board 157
3.3 Removing the MSL Assembly 159
3.4 Removing the Power Supply 159
3.5 Removing the Frame Housing and Serial Number Plate 160
Multi-Measurement Module (MMS) Disassembly 160
Tools required 160
Removing the Front Cover 161
Removing the Mounting Pin 161
Removing the Top Cover 162
Removing the DC/DC Board 162
Removing the MSL Flex Assembly 163
Reassembling the MSL Flex Assembly 164
Removing the NBP pump 165
Refitting the new NBP Pump 166
Refitting the DC/DC board 167
Refitting the Cover 168
Refitting the Front Cover 169
Final Inspection 169
MMS Extensions - Exchanging the Top Cover, MSL Flex Cable and the Dual Link Bar 170
Exchange Procedures 170
Disassembly Procedures for the M3015A MMS Extension (HW Rev. A) 181
5
Removing the Front Cover 181
Refit Procedures for the MMS Extension 185
Smart Battery Charger LG1480 (M8043A) 186
Cleaning the Air Filter Mats 187
Replacing the Fan 187
IntelliVue Instrument Telemetry (IIT) 189
Docking Station 190
Exchanging the Main Board 190
Exchanging the Flex Cable 192
6 Parts 197
MP20/MP30 Parts 198
Multi-Measurement Module (MMS) Parts 203
MMS Part Number Overview and Identification 203
MMS Firmware Overview 205
MMS Part Numbers - Front Bezel for M3001 #A01 & #A03 206
MMS Part Numbers - Front Bezel for M3001 #A02 208
MMS Part Numbers - Top Cover and MSL Assembly 209
MMS Exchange Part Numbers 210
MMS Part Numbers - Label Kits 212
MMS Part Numbers - NBP Assembly 213
MMS Extension Parts (M3012A, M3014A, M3015A and M3016A) 213
MMS Extension Part Numbers - Release Mechanisms 213
MMS Extension Part Numbers - Top Cover, Flex Cable and Link Bar 214
MMS Extension Part Numbers - Front Bezels 214
Exchange Parts List 221
IntelliVue X2 Part Numbers 223
BISx Solution Replacable Parts 224
Smart Battery Charger Part Numbers 224
IntelliVue Instrument Telemetry Part Numbers 225
IntelliVue 802.11 Bedside Adapter Part Numbers 226
Docking Station Part Numbers 226
External Display Part Numbers 227
Remote Alarm Device Part Numbers 229
Remote Extension Device Part Numbers 230
7 Installation Instructions 231
Installation Checklist 231
Unpacking the Equipment 232
Initial Inspection 232
Mechanical Inspection 232
Electrical Inspection 232
Claims For Damage and Repackaging 233
Mounting Instructions 233
Connecting the Monitor to AC Mains 235
6
Connections 236
Installing Interface Boards 237
Connection of Devices via the MIB/RS232 Interface 240
Connection of USB Devices 240
Installing the Docking Station 244
Installing Remote Devices 244
Mounting the 15” Remote Display (M8031A) 244
Mounting the 15” Remote Display (M8031B) 245
Mounting the 17” Remote Display (M8033A/B/C) 245
Multi-Measurement Module 247
PS/2 Keyboard/Mouse 256
Philips Clinical Network (Wired) 256
Philips Clinical Network (Wireless) 256
Nurse Call Relay 257
Connections 257
ECG Out Functionality 257
Connections 257
Configuration Tasks 258
Checking Country-Specific Default Settings 258
Setting Altitude, Line Frequency, ECG Cable Colors and Height & Weight Units 259
Setting Altitude and Line Frequency 259
Configuring the Equipment Label 259
Configuring the printer 260
Handing Over the Monitor 260
8 Site Preparation 261
Introduction 261
Site Planning 261
Roles & Responsibilities 262
Monitor M8001A and M8002A Site Requirements 264
Space Requirements 264
Environmental Requirements 264
Electrical and Safety Requirements (Customer or Philips) 265
Remote Device Site Requirements 266
Connecting Non-Medical Devices 267
Multi-Measurement Module (MMS) M3001A and IntelliVue X2 M3002A 267
Remote Displays (M8031A) 270
Remote Displays (M8031B) 271
Remote Displays - M8033A 272
Remote Displays - M8033B 273
Remote Displays - M8033C 274
Remote Alarm Devices 276
Remote Extension Device 277
Local Printer 278
Philips Medical LAN 279
7
RS232/MIB/LAN Interface
Nurse Call Relay Interface 280
ECG Out Interface 281
279
9 Gas Analyzers 283
10 Index 285
8
1
1Introduction
This Service Guide contains technical details for the IntelliVue MP20, MP20 Junior and MP30
Patient Monitor, the Multi-Measurement Module (MMS), the IntelliVue X2, 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 table of contents at the left of the
screen to select the desired topic. Links to other relevant sections are also provided within the
individual topics. In addition, scrolling through the topics with the page up and page down keys is
also possible.
9
1 Introduction Abbreviations
Abbreviations
Abbreviations used throughout this guide are:
Name Abbreviation
IntelliVue MP20/MP30 Patient Monitor the monitor
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.
10
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 effective use of the product.
Failure to observe a caution may result in minor or moderate personal injury or damage to the
product or other property, and possibly in a remote risk of more serious injury.
11
2Theory of Operation
Monitor Theory of Operation
The IntelliVue MP20/MP20Junior/MP30 Patient Monitor:
- displays real-time data
2
NOTE
- controls the attached measurement server
- alarms in the case of patient or equipment problems
- offers limited data storage and retrieval (trending)
- interfaces to the Philips Clinical Network and other equipment
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 slave display. These elements cooperate as one single integrated real-time
measurement system.
The following descriptions may vary depending on the monitor option purchased.
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2 Theory of Operation Monitor Theory of Operation
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
interconnected 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
14
Monitor Theory of Operation 2 Theory of Operation
Hardware Building Blocks
The following hardware building blocks make up the monitoring system:
IntelliVue MP20
The MP20 monitor:
- integrates the display and processing unit into a single package
- uses a 10.4” TFT SVGA color display
- uses the Philips Navigation Point as primary input device; computer devices such as mice,
- supports the MMS and MMS extensions.
Building Blocks:
trackball, and keyboard can be added optionally
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2 Theory of Operation Monitor Theory of Operation
IntelliVue MP30
The MP30 monitor:
- integrates the display and processing unit into a single package
- uses a 10.4” TFT XGA color display
- uses the Touchscreen and Philips Navigation Point as primary input devices. Computer devices
such as mice, trackball, and keyboard can be added optionally.
- supports the MMS and MMS extensions
Building Blocks:
Optional Hardware
One slot is provided for one of three available system interface boards. 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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Monitor Theory of Operation 2 Theory of Operation
Compatible Devices
M8045A Docking Station
M3001A Multi-Measurement Module (MMS)
M3002A IntelliVue X2
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2 Theory of Operation Monitor Theory of Operation
Power Supply
M3012A, M3014A, M3015A, M3016A MMS Extensions
Power Supply Architecture
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Monitor Theory of Operation 2 Theory of Operation
The AC/DC converter transforms the AC power coming from the power plug into 14 V/80W DC
source and isolates the monitoring system from the AC power mains.The 14V is distributed via
power bus and supplies power to all the components of the system: The 48V DC power needed for
the MMS and MMS Extension is created by an isolating DC/DC converter. The power needed for
the backlights is converted to 12V DC by the backlight DC/DC converter. The CPU and the
non-isolated I/O boards are supplied with 3.3 V and 5 V DC power. Isolated interface boards
require a power of 10V AC. The remote HIF board and the LEDs are supplied with 12V DC
power.
CPU Boards
The CPU boards have an MPC852/50 MHz processor in the patient monitor and an
MPC860/50MHz in the MMS that provides a number of on-chip, configurable interfaces. An array
of fast UARTS with configurable protocol options are implemented in an ASIC (along with other
system functions such as independent watchdogs etc.), providing interfacing capabilities to
measurement modules and System Interface 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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2 Theory of Operation Monitor Theory of Operation
System Interface and 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:
System Interface boards:
- Video for slave display
- Philips Clinical Network (LAN wired or wireless)
- Basic Alarm Relay (Nurse Call)
- Docking Interface
I/O boards:
- PS/2
- MIB/RS232
- Flexible Nurse Call
- Parallel printer
- USB
- Remote devices (Remote Alarm Device, Remote Extension Device)
- BISx Interface
- 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.
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Monitor Theory of Operation 2 Theory of Operation
Data Flow
The following diagram shows how data is passed through the monitoring system. The individual
stages of data flow are explained below.
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 Server
- External measurement devices
- Server systems on the Philips Clinical Network
The Measurement Server connected to the internal LAN convert patient signals to digital data
and applies measurement algorithms to analyze the signals.
Data can be also acquired from devices connected to interface boards of the monitor. Software
modules dedicated to such specific devices convert the data received from an external device to
the format used internally. This applies to the Anesthetic Gas Module.
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
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2 Theory of Operation Monitor Theory of Operation
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.
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 Navigation Point, 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).
22
Monitor Theory of Operation 2 Theory of Operation
Monitor Applications
The monitor applications provide additional system functionality over the basic measurement and
monitoring capabilities. This includes for example trending, report generating, event storage or
derived measurements.
In general, the monitor applications use the data provider system service to access the measurement
data. Application interfaces to the other system services allow the application to visualize data, to
store data over extended periods of time or to output data to other devices.
Internal LAN (Measurement Link)
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 allow flexible cabling options (star topology, daisy
chaining of servers).
23
2 Theory of Operation Monitor Theory of Operation
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 components
(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 Theory of Operation 2 Theory of Operation
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
25
2 Theory of Operation Monitor Theory of Operation
Block Diagram Legend
Functional Block Description
Services
Operating System The Operating System (OS) provides a layer of isolation between the specific
hardware implementation and the application software. The OS performs system
checks and allocates resources to ensure safe operation when the system is first
started. This includes internal self-tests on several hardware modules and
configuration checks for validity of configuration with the operating software.
During normal operation, the OS continues to run checks on system integrity. If
error conditions are detected the OS will halt monitoring operations and inform
the operator about the error condition.
System Services The System Services provide generic common system services.
In particular:
They use a real-time clock component to track time. They synchronize to network
time sources and verify the accuracy of the system time information. They are also
responsible for managing persistent user configuration data for all Measurement
Servers and IntelliVue Patient Monitoring System software modules. User
configuration data is stored in a non-volatile read/write storage device
Applications
Reports The Reports Service retrieves current and stored physiological data and status data
to format reports for printing paper documentation. 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
The Reports service generates report data which can be printed on a local or a
central printer.
26
Monitor Theory of Operation 2 Theory of Operation
Functional Block Description
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. The Record
Service can also send data to a central recorder.
Alarm The Alarm Service contains logic that prioritizes alarm conditions that are
generated either by the Measurement Servers 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
(Desaturation), and supporting the operator in visualizing Apnea situations.
27
2 Theory of Operation Monitor Theory of Operation
Functional Block Description
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.
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.
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.
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
29
2 Theory of Operation Monitor Theory of Operation
Functional Block Description
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.
Docking Interface The docking interface provides necessary connections for docking an MP20/30 or
MP40/50 monitor onto the docking station.
BISx Interface The BISx interface allows the usage of Aspect’s BISx solution with an MP20/30
monitor.
IIT Interface The IIT interface allows operation of the
MP2/X2/MP5/MP20/MP30/MP40/MP50 monitors with IntelliVue Instrument
Telemetry.
30
Monitor Theory of Operation 2 Theory of Operation
31 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) and the MMS
Extensions.
These tests must be performed by qualified personnel only. 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.
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.
Recommended Frequency
Perform the procedures as indicated in the suggested testing timetable. These timetable
recommendations do not supersede local requirements.
Tests Frequency
Preventive Maintenance*
Other Regular Tests
Table 1: Suggested Testing Timetable
NBP Performance Once every two years, or more often if
Microstream CO2 Calibration
(M3015A)
Visual Inspection
Power On Test
specified by local laws.
Once a year or after 4000 hours of
continuous use and following any
instrument repairs or the replacement of
any instrument parts.
Before each use.
34
When to Perform Tests 3 Testing and Maintenance
Tests Frequency
Performance Assurance
Tests
Temperature Accuracy
ECG/Resp Performance
NBP Performance
Invasive Pressure Performance
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.
SpO2 Performance
Mainstream CO2 Accuracy Check
Sidestream CO2 Accuracy Check and
Flow Check
BIS Performance
Nurse Call Relay Performance
ECG Sync Pulse Performance
Safety
Tests
Visual
Electrical
Protective Earth
Equipment Leakage Current
Patient Leakage Current
System Test Once every two years
*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the CO2
Visual Inspection After each service event.
pump/CO
scrubber replacement procedure. This is required every three years or after 15000
2
operating hours.
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
Once every two years and after repairs
where the power supply has been removed
or replaced or the monitor has been
damaged by impact.
Tests Required
(When performing...
...Complete these tests)
Installation
Installation of a monitor in combination with a
medical or non-medical device connected to the
Perform Visual Inspection, Power On and
System Tests
same multiple socket outlet.
35
3 Testing and Maintenance When to Perform Tests
Service Event
(When performing...
Installation of a standalone monitor with no
display connected to the video output
Installation of a monitor with a medical display
specified by Philips
Installation of a monitor with an off-the-shelf
display (non-compliant with IEC60601-1)
Installation of monitor with IntelliVue
Instrument Telemetry (IIT)
Installation of a monitor with AGM or
IntelliVue G1/G5, connected to separate mains
sockets.
Installation of a monitor with IT equipment
e.g. printer, PC connected via a functional
connection e.g. Centronics or USB.
Installation of monitor with IntelliVue 802.11
Bedside Adapter
Tests Required
...Complete these 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, Power On and IIT
communication test
Perform Visual Inspection and Power On Tests
Perform Visual Inspection, Power On and
System Tests
Perform Visual Inspection, Power On and
IntelliVue 802.11 Bedside Adapter
Communication Test
Installation of networked monitor (LAN) Perform Visual Inspection , Power On and
System Tests
Preventive Maintenance
Preventive Maintenance*
Perform preventive maintenance tests and
procedures:
- NBP calibration
- Microstream CO2 calibration (M3015A)
Other Regular Tests and Tasks
Visual Inspection
Perform Visual Inspection test block
36
When to Perform Tests 3 Testing and Maintenance
Service Event
(When performing...
Power On Test
Repairs
Repairs where the monitor, 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 where the unit has been opened (front
and back separated).
Tests Required
...Complete these tests)
Perform Power On test block
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, all Safety
Tests and Basic Performance Assurance Test
Repairs of IntelliVue Instrument Telemetry
(IIT) Module
Perform Visual Inspection, Power On Test
Block and IIT communication test
Repairs of IntelliVue 802.11 Bedside Adapter Perform Visual Inspection, Power On and
IntelliVue 802.11 Bedside Adapter
Communication Test
Repairs of the MMS or X2 (all service events
where the MMS or X2 have been opened)
Perform Visual Inspection, Power On, all Safety
Tests and Basic Performance Assurance Test.
If a certain parameter seems suspicious, perform
Full Performance Assurance Test for this
parameter.
Repairs where the NBP pump of the MMS or
X2 has been replaced
Perform Visual Inspection, Power On, all Safety
Tests, Basic Performance Assurance Test and
NBP Performance Test and Calibration
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 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 removed)
37
Perform Visual Inspection, Power On Test and
Basic Performance Assurance Test
3 Testing and Maintenance When to Perform Tests
Service Event
(When performing...
Tests Required
...Complete these tests)
Performance Assurance
Basic Performance Assurance Perform basic performance assurance tests for
the respective monitoring system component.
Full Performance Assurance Perform all accuracy and performance test
procedures listed in the following sections. If a
particular measurement is in question, perform
the measurement performance test only.
Upgrades
Software Upgrades Perform Visual Inspection, Power On Test and
Basic Performance Assurance Test unless
otherwise specified in the Upgrade Installation
Notes shipped with the upgrade.
Hardware Upgrades Perform Visual Inspection, Power On Test and
Basic Performance Assurance Test unless
otherwise specified in the Upgrade Installation
Notes shipped with the upgrade.
NOTE
Hardware Upgrades where IntelliVue
Instrument Telemetry (IIT) is installed
Perform Visual Inspection, Power On Test,
Basic Performance Assurance Test and IIT
communication Test
Hardware Upgrades where IntelliVue 802.11
Bedside Adapter is installed
Perform Visual Inspection, Power On Test,
Basic Performance Assurance Test and IntelliVue
802.11 Bedside Adapter Communication Test
Combining or Exchanging System
Components
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.
38
Testing Sequence 3 Testing and Maintenance
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
Visual Test
See
(see "Before Each Use" on page
40).
Safety Test Procedures
See
See
Performance Assurance Tests
Reporting of Test Results
See
See
Evaluation of Test Results
(on page 43).
(on page 66).
(on page 85)
(on page 88)
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.
39
3 Testing and Maintenance Visual Inspection
Visual Inspection
Before Each Use
Check all exterior housings for cracks and damage. Check the condition of all external cables,
especially for splits or cracks and signs of twisting. If serious damage is evident, the cable should be
replaced immediately. Check that all mountings are correctly installed and secure. Refer to the
instructions that accompany the relevant mounting solution.
After Each Service, Maintenance or Repair Event
Ensure all fuses accessible from the outside comply with the manufacturer’s specification.
Check:
- the integrity of mechanical parts, internally and externally.
- any damage or contamination, internally and externally
- 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. Switch on the monitoring system. This includes connected displays, MMS, X2, MMS
2. Make sure that all steps listed in the table Initial Instrument Boot Phase in the Troubleshooting
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.
Extensions and gas analyzers.
section are completed successfully and that an ECG wave appears on the screen.
40
Safety Tests 3 Testing and Maintenance
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
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
(on page
51) 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.
System Test
41
3 Testing and Maintenance Safety Tests
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 skilled 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 device is connected to the medical device during an installation, the resulting medical
electrical system must comply with IEC/EN 60601-1-1.
- Perform safety tests as described on the following pages.
42
Safety Tests 3 Testing and Maintenance
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, together 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
L, N
Supply mains
Supply mains terminals
PE
Mains part
F-type applied part
Protective earth
Protective earth terminal
Applied part
Measuring device
Resistance measuring device
Connection to accessible
conductive parts
.........
Optional connection
After each service, maintenance or repair event:
Ensure all fuses accessible from the outside comply with the manufacturer’s specification.
Check:
- the integrity of mechanical parts, internally and externally.
- any damage or contamination, internally and externally.
- that no loose parts or foreign bodies remain in the device after servicing or repair.
- the integrity of all relevant accessories.
43
3 Testing and Maintenance Safety Tests
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.
44
Safety Tests 3 Testing and Maintenance
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 the test.
Protective Earth Resistance Test - Setup Example
Equipment Leakage Current Test - Setup Example
45
3 Testing and Maintenance Safety Tests
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).
S(1): Protective Earth Resistance Test
Test to perform:
46
Safety Tests 3 Testing and Maintenance
Measuring circuit for the measurement of Protective Earth Resistance in medical electrical
equipment that is disconnected from the supply mains.
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)
NOTE
- 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.
S(2): Equipment Leakage Current Test - Normal Condition
Test to perform:
47
3 Testing and Maintenance Safety Tests
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 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)
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
S(3): Equipment Leakage Current Test - Single Fault Condition
Test to perform:
48
Safety Tests 3 Testing and Maintenance
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).
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)
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
49
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 invasive blood pressure/temperature
measurement block. This avoids a short and the potential of exceeding the limit for the current.
Test to perform:
50
System Test 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 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.
51
3 Testing and Maintenance System Test
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.
52
System Test 3 Testing and Maintenance
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.
53
3 Testing and Maintenance System Test
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.
- Declaration of Conformity.
- 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.
54
System Test 3 Testing and Maintenance
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.
55
3 Testing and Maintenance System Test
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.
56
System Test 3 Testing and Maintenance
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 protective 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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3 Testing and Maintenance System Test
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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System Test 3 Testing and Maintenance
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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3 Testing and Maintenance System Test
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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System Test 3 Testing and Maintenance
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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3 Testing and Maintenance System Test
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 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 3 Testing and Maintenance
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3 Testing and Maintenance System Test
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 3 Testing and Maintenance
System Test Procedure
If the medical device has already been tested as a standalone device e.g. during factory safety testing,
an equipment leakage current test must be performed once the device is connected to the network.
Otherwise 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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3 Testing and Maintenance Preventive Maintenance Procedures
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 analyzer for further details on how to set 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).
Microstream CO2 Calibration
Perform the Microstream CO2 calibration once a year or after 4000 hours of continuous use
(whichever comes first) and following any repairs or the replacement of any instrument parts. See
Microstream CO2 Performance Test
(on page 75) for details.
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.
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Performance Assurance Tests 3 Testing and Maintenance
Basic Performance Assurance Test
This section describes the basic performance test procedure. Please refer to the section When to
Perform Tests for detailed information on when which test procedure is required.
Procedure:
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.
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 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
120bpm +/- 2bpm
Respiration Performance Test 40 rpm +/- 2 rpm or
45 rpm +/- 2 rpm
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3 Testing and Maintenance Performance Assurance Tests
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 the
T-wave begins
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%
value on your finger (this assumes that you are healthy).
2
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Performance Assurance Tests 3 Testing and Maintenance
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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3 Testing and Maintenance Performance Assurance Tests
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, calibrate
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 280
2. Watch the pressure value for 60 seconds.
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
mmHg pressure on the expansion chamber.
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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Performance Assurance Tests 3 Testing and Maintenance
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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3 Testing and Maintenance Performance Assurance Tests
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 sensor.
2
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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Performance Assurance Tests 3 Testing and Maintenance
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:
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.
5% of 760 mmHg pressure ±2mmHg
36 mmHg 40 mmHg
2. Switch on the patient monitor.
3. Enter the monitor’s Service Mode.
4. Using the sensor status provided in the M2741A Serial protocol, wait for the M2741A sensor to
warm up to its operating temperature.
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3 Testing and Maintenance Performance Assurance Tests
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 CO
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.
extension pump draws. It should be
2
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Performance Assurance Tests 3 Testing and Maintenance
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
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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3 Testing and Maintenance Performance Assurance Tests
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
outlet.
mCO
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 are
2
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 mCO2 assembly of the MP5 must be
exchanged.
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Performance Assurance Tests 3 Testing and Maintenance
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
2. Connect the FilterLine to the mCO
inlet.
2
gas outlet.
2
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 pump
draws (x5). It should be 50 ml/min ± 7.5 ml/min. If the value is within tolerance, proceed to
the CO2 Gas calibration check. If the value is not within tolerance, calibrate as follows.
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.
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.
77
FilterLine.
2
3 Testing and Maintenance Performance Assurance Tests
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 regulator to allow 5% CO
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 the
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. Allow
2
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%.)
12. Open the valve on the calibration gas to allow CO
gas to flow into the extension. Allow the
2
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.
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Performance Assurance Tests 3 Testing and Maintenance
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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3 Testing and Maintenance Performance Assurance Tests
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 values
2
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 generates 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.
Nurse Call Relay Performance Test
The nurse call relay performance test can be performed either at the phone jack type connector (this
only tests one relay) or at the multi-port nurse call connector (to test all three relays).
Phone Jack Type Connector Test (Traditional Nurse Call)
This test checks the operation of the traditional Nurse Call Relay. The Nurse Call Relay test is
recommended for customer sites where the nurse call is in use. The Nurse Call relay functions as
follows:
- Standard Operation—Relay open.
- Alarm Condition—Relay closed.
Tools required: Ohmmeter.
1. Plug a phono connector into the Nurse Call Relay connector.
2. Connect the ohmmeter.
80
Performance Assurance Tests 3 Testing and Maintenance
3. If no alarm occurs, the relay contacts are open. When an alarm occurs, the relay contacts close.
(relay loop)
Ring
(relay loop)
Tip
Sleeve
(ground)
black
red
4. The expected test result is: Alarm condition - Relay closed.
Test Expected test results
Nurse Call Relay Performance Test Alarm Condition—Relay closed
Multi-Port Nurse Call Connector Test (Flexible Nurse Call)
This test checks the operation of the Flexible Nurse Call Relay. The Nurse Call Relay test is
recommended for customer sites where the nurse call is in use. The following diagram and table
show the pins and relay identifiers of the connector:
Pin Cable Color
Relay
Coding
1 black R2-closure
2 brown R2-middle
3 red R2-opener
4 orange R3-closure
5 yellow R3-middle
6 green R3-opener
7 blue n/a
8 purple n/a
9 gray n/a
10 white n/a
11 pink R1-closure
12 light green R1-middle
13 black/white R1-opener
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3 Testing and Maintenance Performance Assurance Tests
Pin Cable Color
Coding
Relay
14 brown/white n/a
15 red/white n/a
16 orange/white n/a
17 blue/white R_failure_closure
18 purple/white R_failure_middle
19 green/white R_failure_opener
20 red/black n/a
The Nurse Call relay functions as follows:
- During standard operation R1,R2,R3 _opener are closed; R1,R2,R3_closure are open.
- During alarm condition—R1,R2,R3_opener are open; R1,R2,R3_closure are closed.
Tools required: Ohmmeter.
1. Plug an M8087-61001 cable into the Nurse Call Relay connector.
2. Connect the ohmmeter and measure the pins as indicated in the diagram and table.
3. The relay contacts should behave as described above. The behavior may vary depending on
configuration choices. See the Configuration Guide for details on Alarm Relay settings.
4. The expected test results depend on the relay contact used. Please check that the correct relay
activity is initiated during alarm condition.
Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed)
1. Switch on the monitor.
2. Remove the battery and disconnect the monitor from AC power.
3. The Power Loss Alarm Buzzer should beep for about one minute.
4. To switch off the alarm sound, either press the power button, connect the monitor to AC power
or insert a battery
Test Expected test results
Power Loss Alarm Buzzer Performance
Beep for one minute
Test
Docking Station Performance Test
1. Place the monitor on the docking station and close the lever.
2. Check that the green power LED lights up when the docking station is connected to AC Power.
82
Performance Assurance Tests 3 Testing and Maintenance
3. Check that the monitor’s AC Power LED lights up to indicate it is receiving power through the
docking station. (PO:P)
IIT Communication Test
1. Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the
monitor.
2. Go into Configuration mode and, in the Network menu, set the RF Access Code in each
profile to match your installation.
3. Go into Service Mode. Select Main Setup -> Instr. Telemetry to access the
Instrument Telemetry Service window.
4. Proper installation of the IIT module is assured by connecting to an access point over the
wireless link. Place the monitor with the IIT module installed in close proximity to the access
point (e.g. if the access point is mounted on the ceiling, place the monitor directly below). Wait
until the Conn.Status field in the Instrument Telemetry Service window shows Active. Take
the monitor approximately 5 m away from the access point. There should be no walls or other
obstacles between the monitor and the access point. The following should apply:
- Observe the RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds.
The RSSI value should be around -50 ±10 in a 5 m distance from the access point used
and the IIT link should be active, i.e. the Conn.Status field should be Active and the
other fields should contain values. If the RSSI value is significantly lower, check the
distance to the access point and the antenna orientation at both the monitor and the access
point (both should be vertical).
- Remove the antenna. The RSSI value should be around -90 ±10. The IIT link may be
active but the connection could be unreliable. The Conn. Status field may toggle
between Inactive and Seeking. If the difference between the RSSI values measured with and
without antenna is significantly lower, check the antenna and the antenna connector for
damage and verify that the cable fom the IIT adapter to the antenna connector plate is
connected properly.
5. If this test fails, retry in a different physical area with a different access point.
Error Conditions:
- The field MAC Instr. Tele should show a value unequal to 0000 0000 0000. If it does
not, there is a communication problem between the monitor and the IIT adapter.
- With an incorrect RF Access Code or an incorrect or defective antenna installation, the
fields IP Address,Server IP, Subnet Mask, and
Telemetry Service window will stay blank. The field Conn. Status will slowly toggle
between Inactive and Seeking.
6. Perform the Access Point Controller (APC) test blocks as described in the Philips IntelliVue
Wireless Network Installation and Configuration Guide.
IntelliVue 802.11 Bedside Adapter Communication Test
1. Make sure the LAN cable is disconnected from the rear of the monitor, then switch on the
monitor.
RSSI in the Instrument
2. Go into Service Mode and select Main Setup -> Network -> Setup WLAN. In the
Setup WLAN menu:
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3 Testing and Maintenance Performance Assurance Tests
- set Mode to either 802.11Ah, 802.11G, 802.11Bg (not recommended), Auto (not
recommended) or None (this setting disables the wireless LAN functionality permanently),
to match your wireless infrastructure installation.
- set SSID to match your installation.
- set the Country code to “1000”. Setting the country code to this value will automatically
adjust the regulatory domain to match the configuration of the infrastructure. Do not set
the country code to values other than “1000” unless otherwise instructed.
- set the Security Mode to WPA(PSK) and enter the WPA password (string between
8 and 63 characters).
3. Select Main Setup -> WLAN Diagnostic to access the service window.
4. Proper installation of the IntelliVue 802.11 Bedside Adapter is assured by connecting to an
access point over the wireless link. Place the monitor with the IntelliVue 802.11 Bedside
Adapter installed in close proximity to the access point (e.g. if the access point is mounted on
the ceiling, place the monitor directly below). Wait until the Conn.Status field in the
service window shows Authenticatd (for Rel. C.0 monitors)or Connected (for Rel D.0 or higher).
Take the monitor approximately 5 m away from the access point. There should be no walls or
other obstacles between the monitor and the access point. The following should apply:
- Observe the RSSI (Received Signal Strength Indicator) value for at least 5 - 10 seconds.
The RSSI value wil fluctuate but should stay above 30 in a 5 m distance from the access
point used. The wireless link should be active, i.e. the Conn.Status field should be
Authenticatd (for Rel. C.0 monitors)or Connected (for Rel D.0 or higher), and the other
fields should contain values. If the RSSI value is significantly lower, check the distance to
the access point and the antenna orientation at the monitor. The antenna orientation
should be vertical, but the physical placement of the monitor or other equipment within its
vicinity as well as walls or other obstacles may influence the antenna orientation required to
receive the best RSSI value.
5. If this test fails, retry in a different physical area with a different access point.
6. Perform the Wireless Switch test blocks as described in the Philips IntelliVue 802.11 a/g
Infrastructure Installation and Configuration Guide.
Test Expected test results
IntelliVue 802.11 Bedside Adapter
RSSI value above 30
Performance Test
84
Reporting of Test Results 3 Testing and Maintenance
Reporting of Test Results
Philips recommends all test results are documented in accordance with local laws. Authorized Philips
personnel report test result back to Philips to add to the product development database. While
hospital personnel (biomedical engineers or technicians) do not need to report results to Philips,
Philips recommends that they record and store the test results in accordance with local laws.
The following table lists what to record after completing the tests in this chapter. Record the results
in the empty column in Table 16.
The following is a guide as to what your documentation should include:
- Identification of the testing body (for example, which company or department carried out the
tests).
- Name of the person(s) who performed the tests and the concluding evaluation.
- Identification of the device(s) and accessories being tested (serial number, etc.).
- The actual tests (incl. visual inspections, performance tests, safety and system tests) and
measurements required
- Date of testing and of the concluding evaluation.
- A record of the actual values of the test results, and whether these values passed or failed the
tests.
- Date and confirmation of the person who performed the tests and evaluation.
The device under test should be marked according to the test result: passed or failed.
Carrying Out and Reporting Tests
Test Report
Testing Organization:
Name of testing person:
Responsible Organization:
Device Under Test: ID-Number
Product Number: Serial No.:
Accessories:
Measurement Equipment (Manufacturer, Type, Serial
No.):
Test before putting into service (reference value)
Recurrent Test
Test after Repair
Functional Test (parameters tested):
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3 Testing and Maintenance Reporting of Test Results
Test and Inspection Matrix
Test or
Test
Visual
Inspection
Inspection to be
Performed
Perform Visual
Inspection
Power On Power on the unit.
Does the self-test
complete
successfully
Noninvasive
Blood Pressure
Perform the
Accuracy Test
Performance
Tests
Performance
Leakage Test
Performance
Linearity Test
Performance
Valve Test
Record the Results (mandatory for
Expected Test Results
Philips Personnel only)
What to record Actual Results
Pass or Fail V:P or V:F
If Yes, Power On test is passed PO:P or PO:F
X1 = value displayed by
monitor
PN:P/X1 or
PN:F/X1
Difference <= 3mmHg
X2 = leakage test value
X2 < 6 mmHg
X3 = value displayed by
monitor
PN:P/X2 or
PN:F/X2
PN:P/X3 or
PN:F/X3
Difference <= 3mmHg
X4 = value < 10 mmHg PN:P/X4 or
PN:F/X4
Temperature
Performance
Test
All other
performance
tests
Perform the
Temperature
Performance Test
Perform the
remaining
parameter
performance tests,
if applicable
Safety (1) Perform Safety
Test (1):
Protective Earth
Resistance
Safety (2) Perform Safety
Test (2):
Equipment
Leakage Current -
Normal
Condition.
X1= 40°C ± 0.2°C or 100°F ±
0.4°F
See expected results in test
procedures
With mains cable:
Maximum impedance (X1):
<=300 mOhms
With mains cable:
Maximum leakage current
(X1):<= 100 μA
PT: P/X1 or
PT: F/X1
P: P or
P: F
S(1):P/X1 or
S(1):F/X1
S(2): P/X1 or
S(2): F/X1
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Reporting of Test Results 3 Testing and Maintenance
Test or
Test
Inspection to be
Performed
Safety (3) Perform Safety
Test (3):
Equipment
Leakage Current -
Single Fault
Condition (Open
Earth)
Safety (4) Perform Safety
Test (4): Patient
Leakage Current -
Single Fault
Condition, mains
on applied part.
System
(Sys 1-2)
Perform the
system test
according to
subclause 19.201
of IEC/EN
60601-1-1, if
applicable, after
forming a system
Expected Test Results
With mains cable:
Maximum leakage current
(X2):<= 300 mA
Maximum leakage current
(X1): <=50 μA
Equipment Leakage Current:
Sys1 <= 100 μA (Normal
Condition)
Sys2 <= 300μA (Single Fault
Condition
Record the Results (mandatory for
Philips Personnel only)
What to record Actual Results
S(3): P/X2 or
S(3): F/X2
S(4): P/X1 or
S(4): F/X1
Sys: PSys1/PSys2
or
Sys: FSys1/Fsys2
System
(Sys 3)
Perform the
system test
according to
subclause 19.201
of IEC/EN
60601-1-1, if
applicable, after
Protective Earth Leakage
Current if medical electrical
system components are
connected to the same Multiple
Portable Socket Outlet:
Sys3 <= 300 μA
forming a system
Key: P = Pass, F = Fail, X = test value to be recorded
NOTE
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
Sys: PSys3
or
Sys: FSys3
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3 Testing and Maintenance Reporting of Test Results
Evaluation
Yes No
Safety and Functional Test passed
Repair required at a later date, safety and functional test passed
Device must be taken out of operation until repair and passed tests
Device failed and must be taken out of operation.
Notes:
Next Recurrent Test:
Name:____________________________________________________
Date/Signature:_____________________________________________
Evaluation of Test Results
The evaluation of the test results must be performed by appropriately trained personnel with
sufficient product, safety testing and application knowledge.
If any test results are between 90% and 100% of the respective expected result, the previously
measured reference values must be taken into consideration for the assessment of the electrical safety
of the device under test. If no reference values are available, you should consider shorter intervals
between upcoming recurrent tests.
NOTE
88
If any single test fails, testing must be discontinued immediately and the device under test must be
repaired or labeled as defective. Be sure to inform the user about the test failure in writing.
Other Regular Tests 3 Testing and Maintenance
Other Regular Tests
The care and cleaning requirements that apply to the monitor and its accessories are described in the
Instructions for Use. This section details periodic maintenance procedures recommended for the
monitor and its accessories.
Touchscreen Calibration
To access the touchscreen calibration screen:
1. Enter service mode
2. Select Main Setup
3. Select Hardware
4. Select Touch Calibration
Please touch slowly each target as it appears on screen.
Do not power off the monitor until this calibration has
completed.
Touchscreen Calibration Screen
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3 Testing and Maintenance Disabling/Enabling Touch Operation
Make sure you complete the calibration procedure without powering off the monitor mid-way. If
the monitor is powered off after the first point is touched, the touch panel will be deactivated until
the touch calibration is performed again.
If the touchscreen is accidentally mis-calibrated by selecting the wrong spot, you must use another
input device to re-enter calibration mode. If you have the support tool, you can select
Touch Calibration to Default
and it will create a rough calibration which will allow you
Reset
to access the calibration menu again via the touchscreen.
Please refer to the documentation shipped with your selected display for further details on
touchscreen calibration procedures.
Disabling/Enabling Touch Operation
There are two ways to disable/enable touchscreen operation:
1. To temporarily disable touchscreen operation of the monitor, press and hold the
Screen
key. A padlock symbol will appear on the key. Press and hold the Main Screen key
again to re-enable touchscreen operation.
2. To permanently disable touchscreen operation:
a. Enter Service Mode.
b. Select Main Setup
c. Select User Interface
d. Change the Touch Enable selection to no.
To re-enable touchscreen functionality change the
Touch Enable selection to yes.
Main
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Printer Test Report 3 Testing and Maintenance
Printer Test Report
To verify your printer configuration you may want to print a test report.
To print a test report select
Test Rep.
Main Setup -> Reports -> Setup Printers -> Print
Your test report should look like this:
Battery Handling, Maintenance and Good Practices
This section provides some information on how to handle and maintain the batteries in order to get
the best usage from them. Additionally, some good working practices are also given regarding the
correct disposal of the batteries. This section only applies if a battery board is installed in the
monitor.
NOTE
If your monitor is connected to an IntelliVue Information Center, you should make sure that the
IIC uses the text catalog revision B.1 or later, otherwise battery INOPs may not display correctly on
the IIC. Consult your IIC documentation for instructions on upgrading the text catalog.
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3 Testing and Maintenance Battery Handling, Maintenance and Good Practices
About the Battery
The rechargeable Lithium-Ion batteries used in the monitor are regarded as Smart batteries because
they have built-in circuitry. (This circuitry communicates battery-status information to the
Monitor.)
To get the most out of the batteries, observe the following guidelines:
- Condition the batteries only upon maintenance request prompt on display.
- If a battery shows damage or signs of leakage, replace it immediately. Do not use a faulty
battery in the Monitor.
- Capabilities of integrated battery charger: 12.6V, 5 Amps mx.
Actual current / voltage: depends on smart battery request and monitor configuration
The approximate charging time is 4 hours with the monitor switched off and up to 12 hours
during monitor operation, depending on the monitor configuration.
- Battery Disposal—Batteries should be disposed of in an environmentally-responsible manner.
Consult the hospital administrator or your local Philips representative for local arrangements.
Do not dispose of the battery in normal waste containers.
- Battery Storage — Batteries should not remain inside the monitor if they are not used for a
longer period of time. Batteries should be max. 50% charged for storage.
NOTE
Batteries will discharge within about 20 days if they are stored inside the monitor without AC power
connection.
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Battery Handling, Maintenance and Good Practices 3 Testing and Maintenance
Checking the Battery Status
When the Monitor is connected to the AC power supply, the battery charges automatically. The
battery can be charged remotely from the Monitor by using the battery charger. Use only Lithium
Ion battery chargers approved by Philips.
Battery status (level of charge) is indicated several ways:
- LED on the front panel of the Monitor.
- Battery gauge.
- Display of battery time below gauge.
- Battery status window.
- INOP messages.
The AC Power LED is only on when the power cord is connected and AC power is available to the
Monitor. In this case, the battery can be either charging or fully charged.
The battery LED can be green, yellow, or red depending on the following conditions:
NOTE
Battery LED Colors If the monitor is connected
to AC power, this means
If the monitor is running on
battery power, this means
batteries full (>90%)
Green
Yellow
Red, flashing
batteries charging
(battery power < 90%)
or
battery down
2
less than 10 minutes power
remaining
battery malfunction1 battery malfunction1
Red, flashes
intermittently
Red, flashes once when
on/standby switch is
pressed
1
indicated by malfunction symbol and INOP
2
indicated by “battery has no power left” symbol
not enough battery power left to
power monitor
If the batteries were charged to 100%, they will not charge again until the charging status goes below
90%.
If the remaining battery-operating time is less than 10 minutes, the LED flashes red at a repetition
rate of approximately 1.5 flashes per second.
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3 Testing and Maintenance Battery Handling, Maintenance and Good Practices
When the batteries are empty, the Monitor switches off automatically (including the green
On-Off/Standby LED on the front panel). Attempts to restart the Monitor (by pressing the
On-Off/Standby) causes the red LED to emit a single flash. (The flash may have a delay of up to 2.5
sec after pressing the On-Off/Standby key). In this case either recharge the batteries (externally or
internally) or exchange the batteries.
NOTE
If the batteries become too warm or too cold, they will not begin the recharging cycle until the
battery temperature is within range.
Battery Status on the Main Screen
Battery status information can be configured to display permanently on all Screens. It shows the
status of each of the batteries and the combined battery power and battery time remaining. These
symbols are displayed if a battery board is installed, no matter whether batteries are inserted or not.
Battery status symbols:
These symbols tell you the status of the batteries detected and which battery compartment they are
in, either 1 or 2.
Battery power gauge:
This shows the remaining battery power in the combined batteries. It is divided into sections, each
representing 20% of the total power. If three and a half sections are shaded, as in this example, this
indicates that 70% battery power remains. If no batteries are detected, the battery gauge is greyed
out.
Battery malfunction symbols:
If a problem is detected with one of the batteries, these symbols alternate with the battery number to
indicate which battery is affected. They may be accompanied by an INOP message or by a battery
status message in the monitor information line (if battery window is open) providing more details.
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Battery Handling, Maintenance and Good Practices 3 Testing and Maintenance
Battery status symbols Battery malfunction symbols
Battery 1
is present
battery is
empty
Battery
compartments
are empty
battery not
charging as the
temperature is
above or below
the specified
range
Battery
requires
maintenance
Incompatible
battery
(Battery 1)
Battery
malfunction
(Battery 1)
(red) battery
temperature
Battery 2 is
missing,
insert battery
Battery 2 has
no power left
too high
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3 Testing and Maintenance Battery Handling, Maintenance and Good Practices
Explanations of Battery Status and Malfunction Symbols:
Battery requires maintenance: The batteries require conditioning. Refer to “Conditioning Batteries”
for details.
Incompatible Battery: The inserted batteries are checked for certain battery internal parameters. If
these are not correct, the incompatible battery symbol is displayed. Please use only the M4605A
batteries with the IntelliVue monitor. Note that the incompatible battery symbol may also appear if
there is a communication problem between the battery and the battery board.
Temperature outside specified range: The charging of the battery is stopped if the temperature is below
15°C or above 50°C in order to protect the battery. Charging is resumed as soon as the temperature
is within this range.
Battery Temperature too high: This symbol is displayed if the battery temperature goes above 65°C.
In addition the INOP message CHECK BATT TEMP is displayed. If the battery temperature
increases further above 70°C the batteries will switch off for safety reasons. Allow the batteries to
cool down to avoid the monitor switching off.
Battery is empty: The capacity of the battery is ≤200 mAh. Recharge the battery as soon as possible.
Battery has no power left: Either the battery has switched off power delivery but is still
communicating with the battery board - in this case recharge the battery immediately - or the battery
is in deep discharge, i.e. it has switched off power delivery, has stopped communicating with the
battery board and requires pre-charging to restore communication. The INOP CHARGE BATT 1/
BATT 2 is issued to indicate that pre-charging is required. To avoid this condition charge batteries
to 50% for storage. Note that the battery malfunction INOP will eventually be issued if the
pre-charging does not restore battery communication within about 10 minutes.
NOTE
NOTE
Battery Malfunction:Communication between the battery and the battery board could not be
established within about 10 minutes or battery internal data indicates malfunction. Please see the
“Troubleshooting” section for remedies.
If both batteries are malfunctioning or incompatible or require pre-charging and the monitor is not
connected to AC power, it will switch off automatically for safety reasons.
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Battery Handling, Maintenance and Good Practices 3 Testing and Maintenance
Battery Status Window
To access the Battery Status window and its associated pop-up keys, select the
battery status information on the Screen, or select
Capacity, Remaining tells you how much power is left in each battery.
Main Setup -> Battery.
Capacity, Full Charge tells you how much power each battery can hold when fully charged.
Time To Empty tells you approximately how long you can continue to use the monitor with these
batteries. Note that this time fluctuates depending on the system load (how many measurements and
recordings you carry out), the age of the battery, and the remaining capacity of the battery. The time
indication is blanked after unplugging AC or after changing batteries for about 30 seconds (during
calculation of the Time to Empty)
Time To Full is shown in place of Time To Empty if the monitor is connected to AC power,
and tells you how much time is left until the batteries are charged to 90%. Please allow indication to
stabilize for 3 to 5 minutes after beginning the charging cycle. If batteries are charged over 90%
Batteries Full (>90%) is displayed until they are charged to 100%. Then Batt1/Batt2
Fully Charged
is displayed.
97
3 Testing and Maintenance Battery Handling, Maintenance and Good Practices
Viewing Individual Battery Status
To view information for individual batteries, select the pop-up key Battery 1 or
Battery
2.
Documenting Battery Status
To print all battery information in the
1. Select the battery status information on the Screen or select
open the
2. Select the
Battery Status window
Record Status pop-up key to print the information on a connected recorder
or
Select the
Print Status pop-up key to print the information on a connected printer.
Conditioning a Battery
What is Battery Conditioning?
Battery conditioning recalibrates the battery to ensure that it has accurate information on the actual
battery capacity.
Why is Battery Conditioning Necessary?
The capacity of a battery decreases gradually over the lifetime of a battery. Each time a battery is
charged its capacity decreases slightly. Therefore, the operating time of a monitor running on
batteries also decreases with each charge cycle.
Battery Status window,
Main Setup -> Battery to
Battery conditioning ensures that the value stored in the battery for its full capacity takes account of
this decrease, so that the remaining battery charge can be calculated accurately, and the low battery
warning given at the right time.
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Battery Handling, Maintenance and Good Practices 3 Testing and Maintenance
When Should Battery Conditioning be Performed?
Battery conditioning should be performed when indicated by the Battery Status.
NOTE
When the battery status signals a conditioning request, the displayed Time to Full or Time to
Empty
may not be reliable.
What Causes the Conditioning Message on the Monitor?
In addition to the value for the full capacity, the battery also stores a value for the Max Error. The
Max Error tracks the maximum possible deviation of the estimated charge of a battery from the
actual charge.
If a battery is charged or discharged partially, or if it is charged while the monitor is being used, the
accuracy of the “reference points” for the fully discharged and fully charged states decreases, causing
an increase in the value for the Max Error (see diagram, below).
When the Max Error rises over a certain limit, a message is displayed prompting the user to
condition the battery, as described in Conditioning Batteries.
You can reset the value for the Max Error before the battery needs conditioning, by performing the
steps described in”Conditioning Batteries”. The minimum value of the Max Error after conditioning
is 2%.
Conditioning Batteries
Battery conditioning can either be performed in the monitor or with an external battery charger.
99
3 Testing and Maintenance After Installation, Testing or Repair
Battery Conditioning in the Monitor
CAUTION
Do not use a monitor being used to monitor patients to condition batteries. The monitor switches
off automatically when the batteries are empty.
You should condition a battery when its “battery requires maintenance” symbol shows on the
Screen. If conditioning is not performed immediately the monitor will still function according to
specifications. However, the displayed time to empty and time to full will show increasing
inaccuracy. Do not interrupt the charge or discharge cycle during conditioning. To condition a
battery,
1. Insert the battery into a monitor connected to mains power.
2. Charge the battery until it is completely full. Switch the monitor off to decrease the charging
time When the battery LED turns green i.e. the batteries are >90% charged, switch on the
monitor and open the
charged
or Battery 1 / Battery 2 fully charged message is displayed.
Battery Status window. Check that the Batteries fully
3. Disconnect the monitor from mains power, and let the monitor run until the battery is empty
and the monitor switches itself off.
4. Reconnect the monitor to mains power and charge the battery until it is full for use or charge to
50% for storage.
Battery Conditioning with an External Charger
You can use the M8043A Smart Battery Charger for external battery conditioning. For details please
see the IfU for the Smart Battery Charger.
After Installation, Testing or Repair
Before handing the patient monitor over to the end-user, make sure it is configured appropriately
and that it is in monitoring mode. Ensure that the user receives the current revision of the monitor
documentation.
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