Service Guide
IntelliVue Patient Monitor
MP5/MP5T/MP5SC
Rel. L.x
Patient Monitoring
Table of Contents
|
1 Introduction |
7 |
Who Should Use This Guide |
7 |
|
How to Use This Guide |
7 |
|
Abbreviations |
7 |
|
Responsibility of the Manufacturer |
7 |
|
Passwords |
8 |
|
Warnings and Cautions |
8 |
|
|
2 Theory of Operation |
9 |
Monitor Theory of Operation |
9 |
|
|
3 Testing and Maintenance |
25 |
Introduction |
25 |
|
Terminology and Definitions |
25 |
|
Recommended Frequency |
26 |
|
When to Perform Tests |
27 |
|
Testing Sequence |
30 |
|
Visual Inspection |
30 |
|
Safety Tests |
31 |
|
System Test |
55 |
|
Preventive Maintenance Procedures |
66 |
|
Performance Assurance Tests |
66 |
|
Reporting of Test Results |
92 |
|
Other Regular Tests |
95 |
|
Touchscreen Calibration |
95 |
|
Disabling/Enabling Touch Operation |
96 |
|
Printer Test Report |
96 |
|
Battery Handling, Maintenance and Good Practices |
97 |
|
After Installation, Testing or Repair |
105 |
|
|
4 Troubleshooting |
107 |
Introduction |
107 |
|
How To Use This Section |
107 |
|
Who Should Perform Repairs |
107 |
|
Replacement Level Supported |
107 |
|
Software Revision Check |
108 |
|
Software Compatibility Matrix |
108 |
|
Obtaining Replacement Parts |
108 |
|
Troubleshooting Guide |
108 |
3
|
5 Repair and Disassembly |
|
135 |
Who Should Perform Repairs |
135 |
||
Tools required |
136 |
||
Removing the Handle or Bedhanger |
136 |
||
Removing the Predictive Temperature Assembly |
137 |
||
Disassembling the Predictive Temperature Assembly |
139 |
||
Removing/Exchanging the NBP Inlet |
140 |
||
Separating the Front and Back of the Monitor |
142 |
||
Removing the Recorder Slot Cover |
146 |
||
Removing the Internal Quick Mount Solution |
147 |
||
Removing the Short Range Radio (SRR) Interface |
147 |
||
Removing the IntelliVue 802.11 Bedside Adapter Antenna or IIT Antenna (not for MP5T) |
149 |
||
Removing the IntelliVue 802.11 Bedside Adapter (WLAN) (not for MP5T) |
149 |
||
Removing the IntelliVue Instrument Telemetry (IIT) Module (not for MP5T and MP5SC) |
153 |
||
Removing the IntelliVue 802.11 Bedside Adapter/IIT Holder |
154 |
||
Removing the MSL Board (not for MP5T and MP5SC) |
155 |
||
Removing the Backlight Inverter Board (Old NEC Display) |
156 |
||
Removing the Backlight Converter Board (New NLT Display) |
158 |
||
Removing the Power Supply |
159 |
||
Removing the System Interface Board |
160 |
||
Removing the Recorder Board |
161 |
||
Removing the Microstream CO2 Assembly |
163 |
||
Removing the Measurement Block |
169 |
||
Removing the NBP Pump |
173 |
||
Removing the Main Board |
175 |
||
Removing the Touch Assembly |
178 |
||
Removing the Loudspeaker |
180 |
||
Removing the Power Button and LED Assembly |
180 |
||
Removing the LCD Panel |
181 |
||
Exchanging the Backlight (Old NEC Display only) |
182 |
||
Modifying the Nurse Call Relay |
183 |
||
|
6 Parts |
|
187 |
MP5/MP5T/MP5SC Parts |
187 |
||
External Display Part Numbers (not for MP5T) |
201 |
||
Tympanic Thermometer Part Numbers |
203 |
||
Smart Battery Charger Part Numbers |
203 |
||
Test and Service Tools |
204 |
||
|
7 Installation Instructions |
207 |
|
|
|
|
|
Out-Of-Hospital Transport - Standards Compliance |
207 |
||
Electromagnetic Emissions |
209 |
||
Electromagnetic Interference (SRR) |
209 |
||
Installation Checklist |
209 |
||
Unpacking and Checking the Shipment |
210 |
||
Installing the Predictive Temperature Probe |
211 |
4
Installing the Tympanic Thermometer |
213 |
|
Installing the HS1-R Barcode Reader |
216 |
|
Mounting the Monitor |
226 |
|
Connecting the Monitor to AC Mains |
233 |
|
Checking Out The Monitor |
233 |
|
Loading Paper |
236 |
|
Configuration Tasks |
236 |
|
Network Configuration Tasks (Rev H.0 or higher) |
239 |
|
Handing Over the Monitor |
248 |
|
Installing Remote Devices (not for MP5T) |
249 |
|
Clinical Network (Wired and Wireless) |
251 |
|
Philips IntelliVue Information Center |
251 |
|
IntelliVue Instrument Telemetry (IIT)(not for MP5T and MP5SC) |
251 |
|
Short Range Radio |
252 |
|
Connecting the MP5 to a Host Monitor (not for MP5T and MP5SC) |
255 |
|
Nurse Call Relay (not for MP5T) |
255 |
|
ECG Out Functionality (ECG Sync) (not for MP5T and MP5SC) |
256 |
|
ECG Sync Pulse (not for MP5T and MP5SC) |
256 |
|
|
8 Site Preparation |
259 |
Introduction |
259 |
|
Monitor Site Requirements |
261 |
|
Remote Device Site Requirements |
262 |
|
Remote Displays (M8031B) |
264 |
|
Remote Displays - M8033C |
264 |
|
Cabling Options and Conduit Size Requirements |
265 |
|
Touch Cable |
266 |
|
MSL Cables |
266 |
|
Philips Medical LAN |
267 |
|
LAN Interface |
267 |
|
Telemetry Device (Patient Worn Device) cables |
268 |
|
Nurse Call Relay Interface |
268 |
|
ECG Out Interface |
269 |
|
|
9 Gas Analyzers (not for MP5T and MP5SC) |
271 |
10 Specifications |
273 |
|
Essential Performance Characteristics |
273 |
|
MDD Classification |
275 |
|
Classification According to IEC 60601-1 |
275 |
|
Safety and Regulatory Information |
275 |
|
Use Environment |
275 |
|
Disconnecting from Power |
276 |
|
Symbols |
276 |
|
Physical Specifications |
278 |
|
Environmental Specifications |
278 |
5
6
1
This Service Guide contains technical details for the IntelliVue MP5/MP5T/MP5SC Patient Monitor
This guide provides a technical foundation to support effective troubleshooting and repair. It is not a comprehensive, in-depth explanation of the product architecture or technical implementation. It offers enough information on the functions and operations of the monitoring system so that engineers who repair them are better able to understand how it works.
This guide is for biomedical engineers or technicians responsible for installing, troubleshooting, repairing, and maintaining Philips’ patient monitoring systems.
Navigate through the table of contents at the left of the screen to select the desired topic. Links to other relevant sections are also provided within the individual topics. You can also scroll through the topics using the page up and page down keys.
Abbreviations used throughout this guide are: |
|
Name |
Abbreviation |
IntelliVue MP5/MP5T/MP5SC Patient Monitor |
the monitor |
Medical Information Bus |
MIB |
Responsibility of the Manufacturer |
|
Philips only considers itself responsible for any effects on safety, EMC, reliability and performance of the equipment if:
•assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Philips, and
•the electrical installation of the relevant room complies with national standards, and
7
1 Introduction
•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.
In order to access different modes within the monitor a password may be required. The passwords are listed below.
CAUTION
Your hospital/organization is responsible that the passwords listed below are revealed to authorized personnel only.
Monitoring Mode: No password required Configuration Mode: 71034
Demo Mode: 14432
Service Mode: 1345
Consult the configuration guide before making any changes to the monitor configuration.
In this guide:
•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.
•A caution alerts you where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.
8
2
The IntelliVue MP5/MP5T/MP5SC patient monitor is used for monitoring and recording multiple physiological parameters of adults, pediatrics, and neonates. The monitor also generates alarms for the measured parameters. The monitor is used by trained healthcare professionals in a hospital environment.
The monitor stores data in trend, event, and calculation databases. You can see tabular trends (vital signs) and document them on a printer. You can view measurement trend graphs, with up to three measurements combined in each graph, to help you identify changes in the patient's physiological condition. You can view fast-changing measurement trends with beat to beat resolution and see up to four high resolution trend segments. Event surveillance enhances documentation and review of physiologically significant events by automatically detecting and storing up to 50 user-defined clinical events over a 24 hour period.
The monitor can be configured with various different measurement and interface capabilities. The following comparison table shows in detail the differences between MP5, MP5T and MP5SC:
Functionality (including optional features) |
MP5 |
MP5T |
MP5SC |
|
|
|
|
ECG |
yes |
no |
no |
SpO2 |
yes |
yes |
yes |
NBP |
yes |
yes |
yes |
Predictive Temperature |
yes |
yes |
yes |
Temperature |
yes |
no |
no |
Invasive Pressure |
yes |
no |
no |
Carbon Dioxide |
yes |
no |
no |
Microstream CO2 |
yes |
no |
yes |
Direct Telemetry Connection |
yes |
yes |
no |
ECG Output signal |
yes |
no |
no |
LAN networking capability |
yes |
no |
yes* |
WLAN networking capability |
yes |
no |
yes* |
IntelliVue Instrument Telemetry networking capability |
yes |
no |
no |
USB Interface |
yes |
no |
yes |
Short Range Radio capability |
yes |
yes |
yes |
|
|
|
|
9
2 Theory of Operation
Functionality (including optional features) |
MP5 |
MP5T |
MP5SC |
|
|
|
|
Severe Sepsis Screening |
yes |
no |
no |
OxyCRG high resolution trend |
yes |
no |
no |
Neonatal event review |
yes |
no |
no |
Integrated recorder |
yes |
yes |
yes |
Drug Calculator |
yes |
yes |
no |
Gas monitor support |
yes |
no |
no |
Connection to a host monitor (companion mode) |
yes |
no |
no |
Connection to an external display |
yes |
no |
yes |
Nurse call capability |
yes |
no |
yes |
Spot Check |
yes |
no |
yes |
Multi-Patient Spot Check |
no |
no |
yes |
Early Warning Score |
yes |
no |
yes |
|
|
|
|
* For MP5SC LAN and WLAN Networking capability are only available for HL7 export, not for IIC support.
NOTE
The following descriptions may vary depending on the monitor option purchased.
The following diagram discusses specific boundaries within the overall system with respect to their openness and real-time requirements:
System Boundaries
10
2 Theory of Operation
Measurement connections
Built-in measurement block
Philips Clinical Network (wired LAN)
connects multiple patient monitors, information centers, application servers; closed system, only Philips qualified products (tested and with regulatory approval) are connected, Philips is responsible for guaranteed real-time functionality and performance
Philips Clinical Network (wireless)
like Philips Clinical Network (wired) LAN, however due to current wireless technologies available it has reduced bandwidth, longer latencies, reduced functionality
Hospital LAN, Internet
Standard Network, not under Philips control, no guaranteed service, no real-time requirements
11
2 Theory of Operation
The following hardware building blocks make up the monitoring system. (Note that the MP5T and MP5SC do not include all the hardware components shown below):
MP5/MP5T/MP5SC Hardware Building Blocks
12
2 Theory of Operation
The MP5/MP5T/MP5SC monitor:
•integrates the display and processing unit into a single package
•uses a 8.4” TFT SVGA color display
•uses the Touchscreen as input device
•integrates the measurement block (Front End 1 (FE1) and Front End 2 (FE2)) with optional parameter sets
•One slot is provided for one of three available system interface boards. An optional built-in wireless network interface IntelliVue 802.11 Bedside Adapter or IntelliVue Instrument Telemetry) is supported. For further details regarding the wireless network please refer to the M3185A Philips Clinical Network documentation.
•optional recorder
•optional battery
•optional MSL board
•optional Short Range Radio (SRR) board
Power Distribution Architecture
The AC/DC converter transforms the AC power (100-240 V AC range) coming from the power plug into a 24 V / 50W DC source and isolates the monitoring system from the AC power mains.
The 24 V DC is distributed via the Interface Board to the optional battery charging circuit and to the mainand recorder board.
13
2 Theory of Operation
If the interface board contains the optional battery circuits, the power is used to charge the battery and supply the monitoring system. As soon as the AC power source is disconnected, the optional battery starts and keeps the system powered (battery mode). A DC/DC converter on the interface board converts the 8-12.6 V DC power supplied by the battery into 15 V DC power, which is distributed to the monitoring system.
The main board and recorder board contain power supply circuits, which convert the 24 /15 V DC into several voltages supplying the particular components of the monitoring system.
The realtime clock and the buffered RAM is supplied with cont. 3.6 V DC power, provided either by the 24 / 15 V DC system power or by the battery power and converted to 3.6 V DC.
The CPU board has an MPC852/62 MHz processor in the patient monitor that provides a number of on-chip, configurable interfaces. An array of fast UARTS with configurable protocol options are implemented in an ASIC (along with other system functions such as independent watchdogs, video, etc.), providing interfacing capabilities to integrated measurements and System Interface Boards. The serial interfaces can easily be electrically isolated. The main board contains additional video hardware.
The CPUs provide a LAN interface to connect to the Philips Clinical Network (Ethernet).
NOTE
An MP5 in companion mode does not receive its power from the host monitor via the MSL. MP5 is always powered by AC power or battery.
The following is a list of Interface boards which may be present in your monitor, depending on your purchased configuration:
System Interface boards:
•Basic: LAN, Video #J01(no longer orderable)
•Battery: LAN, Battery Board, mCO2 #J02
•Full: LAN, Battery, MIB/RS232, Video, Nurse Call, mCO2 #J40
•Full USB: LAN, Battery, USB, Video, Nurse Call, mCO2 #J43
Note that WLAN, IIT and MSL Interface require the full system interface board or the Full USB system interface board.
The MP5T is delivered only with the Battery system interface board. The MP5SC is delivered only with a Full USB system interface board.
The specifications for the above listed interfaces can be found in the technical data sheet for the monitor and in the Installation and Specifications chapter of the Instructions for Use.
14
2 Theory of Operation
IntelliVue G1/G5 Anesthetic Gas Module
The following diagram shows how data is passed through the monitoring system. The individual stages of data flow are explained below.
Data Flow
Monitoring data (for example patient measurement data in the form of waves, numerics and alerts) is acquired from a variety of sources:
•Measurement Block
The integrated measurements convert patient signals to digital data and apply measurement algorithms to analyze the signals.
•External measurement devices
Data can be also acquired from devices connected to interface boards of the monitor. Software modules dedicated to such specific devices convert the data received from an external device to the format used internally. This applies to the IntelliVue G1/G5 Anesthetic Gas Module (not for MP5T and MP5SC).
15
2Theory of Operation
•Server systems on the Philips Clinical Network
To enable networked applications such as the other bed overview, data can be acquired from server systems attached to the Philips Clinical Network, for example a Philips Information Center
All data that is acquired from integrated measurements or external measurement devices is temporarily stored by a dedicated data provider system service. All monitor applications use this central service to access the data in a consistent and synchronized way rather than talking to the interfaces directly.
This service makes the applications independent of the actual type of data acquisition device.
The amount of data stored in the data provider system service varies for the different data types. For example several seconds of wave forms and the full set of current numerical values are temporarily stored in RAM.
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.
Applications can use high level commands to display monitoring data or status and command windows on the internal LCD panel. These commands are interpreted by the display manager application. This application controls the dedicated video hardware which includes video memory and a special hardware in the ASIC.
User input is acquired from the touchscreen. The system software makes sure that the user input is directed to the application which has the operating focus.
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.
The MP5 communicates as a Multi-Measurement Module (MMS) in companion mode when connected to a host monitor using an IEEE802.3/Ethernet LAN in the Measurement Link (MSL). This network is used to distribute data between the the MP5 and the host monitor, for example:
•Digitized patient signals including wave data, numerical data and status information (typically from the measurement server to a display unit)
16
2 Theory of Operation
•Control data representing user interactions (typically from the display unit to a measurement server)
•Shared data structures, for example representing patient demographical data and global configuration items
The internal LAN allows plug and play configuration of the monitoring system. The system automatically detects plugging or unplugging of measurement servers on the host monitor and configures the system accordingly.
The components on the internal LAN are time-synchronized to keep signal data consistent in the system. Dedicated hardware support for synchronization eliminates any latency of the network driver software.
The integrated LAN provides deterministic bandwidth allocation/reservation mechanisms so that the real-time characteristic of signal data and control data exchange is guaranteed. This applies to the data flow from the measurement server to the monitor (for example measurement signal data) and the data flow from the monitor to a measurement server (for example to feed data to a recorder module).
Integrated communication hubs in the monitor allow flexible cabling options (star topology, daisy chaining of servers).
NOTE
The MP5 does not support any MMS on the MSL.
CO2 sample rate: 20 samples/second Calculation of end tidal CO2 (etCO2):
The M3015A/B MMS Extensions use Microstream® non–dispersive infrared (NDIR) spectroscopy to continuously measure the amount of CO2 during every breath, the amount of CO2 present at the
end of exhalation (etCO2), the amount of CO2 present during inhalation (imCO2), and the respiratory rate. The displayed etCO2 is the maximum etCO2 over the previous peak-picking interval as defined by
the Max Hold setting (configuration mode). It can be set to no peak picking (off), 10 seconds and 20 seconds.
Test method for respiration rate range:
A breath simulator system combined with CO2 and N2 gases was used to simulate respiration rates covering the specified range. The resulting end tidal CO2 values were compared to the expected value. Differences between actual and expected end tidal CO2 values were within the limits of the specified
accuracy for the respective respiration rate, i.e. there was no effect of the respiration rate on the end tidal CO2 values beyond those limits.
The monitoring system may be connected to the Philips Clinical Network, for example to provide central monitoring capabilities or other network services. This connection may be through a normal wired connection or through a wireless connection.
The monitor supports the connection of an internal wireless adapter, depending on the monitor model (#J35, #J45, #J47). Switching between wired and wireless networks is automatically triggered by the plugging or unplugging of the network cable.
17
2 Theory of Operation
After configuration, the monitoring system sends the digitized patient signals including wave data, numerical data and status information onto the network. Control data representing user interactions can be exchanged between the monitoring system and a central station bi-directionally.
Additional protocols are supported for networked applications, for example for the other bed overview function, which allows viewing of monitoring data from other patients on the network.
For plug and play operation, the monitoring system uses the standard BootP protocol to automatically acquire a network address.
The support tool is a Windows application typically installed on the laptop of a customer engineer or a biomedical engineer working in the customer’s own service department.
The purpose of the support tool is to upgrade, configure and diagnose all monitoring components in the system over the network.
The service protocol developed for this purpose uses a raw access to the devices without the need for IP addresses etc. over a standard customer network installation, so that even defective devices can be upgraded as long as the few kBytes of initial boot code are working. The boot code itself can also be upgraded using the same protocol.
The tool allows access to internal service information and to serial numbers. It can be remotecontrolled, for example via a dial-up connection from a response center, provided the proper infrastructure is in place.
For details see the Instructions for Use for the Support Tool.
18
2 Theory of Operation
The following shows the functional block diagram for the monitoring system. A legend explaining terms and diagram elements follows. The information below varies depending on the purchased monitor options.
IntelliVue Patient Monitoring System Functional Block Diagram
19
2 Theory of Operation
Functional Block |
Description |
|
|
|
|
Services |
|
|
Operating System |
The Operating System (OS) provides a layer of isolation |
|
|
between the specific hardware implementation and the |
|
|
application software. The OS performs system checks and |
|
|
allocates resources to ensure safe operation when the system |
|
|
is first started. This includes internal self-tests on several |
|
|
hardware modules and configuration checks for validity of |
|
|
configuration with the operating software. During normal |
|
|
operation, the OS continues to run checks on system integrity. |
|
|
If error conditions are detected the OS will halt monitoring |
|
|
operations and inform the operator about the error condition. |
|
System Services |
The System Services provide generic common system |
|
|
services. |
|
|
In particular: |
|
|
They use a real-time clock component to track time. They |
|
|
synchronize to network time sources and verify the accuracy |
|
|
of the system time information. They are also responsible for |
|
|
managing persistent user configuration data for all |
|
|
Measurement parameters and IntelliVue Patient Monitoring |
|
|
System software modules. User configuration data is stored in |
|
|
a non-volatile read/write storage device |
|
Applications |
|
|
Reports |
The Reports Service retrieves current and stored physiological |
|
|
data and status data to format reports for printing paper |
|
|
documentation. Examples of supported reports: |
|
|
• |
Vital Signs Report |
|
• |
Graphical Trend Report |
|
• |
Event Review Report |
|
• |
Event Episode Report |
|
• ECG Report (12 Lead/Multi-Lead) |
|
|
• |
Test Report |
|
The Reports service generates report data which can be |
|
|
printed on a central printer. |
|
Record |
The Record Service retrieves current and stored physiological |
|
|
data and status data to format a continuous strip recording. A |
|
|
recording can be triggered manually by the operator or |
|
|
automatically by an alarm condition. The Record Service uses |
|
|
the services of the Recorder Interface to control a recorder. |
|
|
The Record Service can also send data to a central recorder. |
|
|
|
|
20
2 Theory of Operation
Functional Block |
Description |
|
|
Alarm |
The Alarm Service contains logic that prioritizes alarm |
|
conditions that are generated by IntelliVue Patient Monitoring |
|
System software modules. Visual alarm signals (messages) are |
|
displayed at the top of the IntelliVue Patient Monitoring |
|
System display and alarm sounds are generated by a |
|
loudspeaker. Alarm conditions may be generated when a |
|
physiological parameter exceeds preselected alarm limits or |
|
when a physiological parameter or any other software module |
|
reports an inoperative status (technical alarm, for example, the |
|
ECG leads may have fallen off the patient). The Alarm service |
|
manages the alarm inactivation states, for example suspension |
|
of alarms, silencing of alarms, and alarm reminder. Alarm |
|
signals may also be configured as latching (alarm signals are |
|
issued until they are acknowledged by the operator, even |
|
when the alarm condition is no longer true). The Alarm |
|
service controls the visual alarm signals (alarm lamps). |
Trend |
The Trend service stores the sample values of physiological |
|
data and status data with a resolution of 12 seconds, 1 minute |
|
or 5 minutes for a period of up to 48 hours. The data is kept |
|
in battery buffered read/write storage and flash memory |
|
devices to be preserved across power failures. The stored data |
|
is protected via consistency checks and checksums. When a |
|
new patient is admitted, the trend database erases all data of |
|
the previous patient. |
OxyCRG |
The OxyCRG (Oxygen CardioRespiroGram) service derives a |
|
high-resolution trend graph from the Beat-to-Beat Heart |
|
Rate, SpO2, and Respiration physiological data. The OxyCRG |
|
is specialized for neonatal applications, allowing the operator |
|
to identify sudden drops in Heart Rate (Bradycardia) and |
|
SpO2 (Desaturation), and supporting the operator in |
|
visualizing Apnea situations. |
ADT |
The ADT (Admit/Discharge/Transmit) service maintains the |
|
patient demographics information. The operator may admit a |
|
new patient, discharge the old patient and enter or modify the |
|
patient demographics. |
Calc Param |
The Calc Param (Calculated Parameters) application performs |
|
calculations on physiological numerical values to derive |
|
calculated parameters like Temperature Difference. |
Interface Managers |
|
|
|
21
2 Theory of Operation
Functional Block |
Description |
|
|
MDSE |
The MDSE (Medical Data Service Element) Interface |
|
Manager is responsible for the exchange of real-time data |
|
between the IntelliVue Patient Monitoring System display unit |
|
and the Measurement parameters and other devices attached |
|
to the network. MDSE establishes and maintains a data |
|
communication link between the devices. It provides |
|
configuration information about the remote device to |
|
applications in the local device and it allows the exchange of |
|
measurement data and status information between the |
|
devices. |
Printer |
The Printer Interface Manager provides a high level interface |
|
to a printer. It provides means to: |
|
• establish a connection to the printer |
|
• transfer data to the printer |
|
• get status of the printer |
|
• close connection to the printer |
|
The Printer Interface Manager also supervises the connection |
|
to the printer and whether the printer accepts data (for |
|
example paper out). The Printer Interface Manager notifies |
|
the operator in such cases. |
Display & Operator Interface |
The Display and Operator Interface Manager performs the |
|
following tasks: |
|
• Screen presentation of real-time and stored physiological |
|
measurement data, alarm condition data and status |
|
information received from the MDSE interface manager, |
|
the Alarm service or other IntelliVue Patient Monitoring |
|
System modules |
|
• Screen presentation of operating controls (control |
|
windows) |
|
• Processing of operating control commands received from |
|
HIF Control interface. The module verifies and interprets |
|
the received commands and forwards them to other |
|
software modules of the IntelliVue Patient Monitoring |
|
System display unit or measurement parameters. |
|
• Sound generation (issues audible alarm signals and |
|
generates audible information signals, for example QRS |
|
and SpO2 tones, operator audible feedback) |
Interfaces |
|
|
|
22
2 Theory of Operation
Functional Block |
Description |
|
|
LAN |
The LAN interface implements the physical layer of IEEE |
|
802.3. The LAN interface performs Manchester encoding/ |
|
decoding, receive clock recovery, transmit pulse shaping, |
|
jabber, link integrity testing, reverse polarity detection/ |
|
correction, electrical isolation, and ESD protection. |
|
Electronically separated interfaces are used for |
|
communication to the Measurement parameters and to the |
|
network. |
Display Controller |
The Display Controller Interface consists of a video |
|
controller, video RAM and the controlling software. The |
|
Display Controller interface processes the high level display |
|
commands (character and graphic generation, wave drawing) |
|
and translates them into pixels, which are written into the |
|
video RAM where the video controller chip generates the |
|
video synchronization signals and the pixel stream for the |
|
Color LCD Display. |
HIF Control |
The HIF (Human Interface Control) interface scans the |
|
Human Interface devices for operator controls (Touch |
|
Screen), formats the collected data and sends it to the display |
|
and Operating Interface. |
ECG-Out Marker-In |
The ECG Out/Marker In interface receives the ECG |
(not for MP5T and MP5SC) |
waveform directly from the ECG/Resp Arrhythmia ST- |
|
Segment physiological algorithm running on the main CPU |
|
and converts the digital ECG signal to an analog ECG signal. |
|
In addition, the ECG Out hardware receives from a |
|
connected device the marker information and forwards this |
|
data to the ECG/Resp Arrhythmia ST-Segment physiological |
|
algorithm. The converted analog signal is used to synchronize |
|
a connected device to the patient’s ECG |
Nurse Call |
The Nurse Call board contains a phone jack type connector |
(not for MP5T) |
with a single close-on-alarm relay. |
MIB |
The MIB interface allows full-duplex, short-haul |
(not for MP5T and MP5SC) |
asynchronous binary communication between the monitor |
|
and an arbitrary (medical/non-medical) device using an eight- |
|
pin RJ45 modular connector. Communication protocols using |
|
this interface can be configured. |
ECG Sync Out |
A pulse signal is provided on the RS-232 interface to allow |
(not for MP5T and MP5SC) |
synchronisation with other medical devices. |
IIT |
The built-in IIT adapter allows operation of the MP5 |
(not for MP5T and MP5SC) |
monitors within IntelliVue Instrument Telemetry |
|
infrastructure. |
WLAN |
The bulit-in WLAN interface allows wireless operation of the |
(not for MP5T) |
MP5 monitors with the IntelliVue 802.11 Bedside Adapter. |
SRR |
The built-in SRR interface allows wireless communication of |
|
the MP5, MP5T and MP5SC monitors with an IntelliVue |
|
Instrument Telemetry Transceiver. |
|
|
23
2 Theory of Operation
Functional Block |
Description |
|
|
MSL |
All components of the monitoring system communicate using |
(not for MP5T and MP5SC) |
an IEEE802.3/ Ethernet LAN in the Measurement Link |
|
(MSL). This network is used to distribute data between the |
|
components |
USB Interface |
The USB interface allows connection of USB devices (Mouse, |
(not for MP5T) |
Keyboard, Barcode Scanner) to the monitor. Note that USB |
|
printers are not supported. |
|
|
24
3
This chapter provides a checklist of the testing and maintenance procedures to ensure the performance and safety of the monitor.
These tests must be performed only by qualified personnel certified by the responsible organization. Qualifications required are: training on the subject, knowledge, experience and acquaintance with the relevant technologies, standards and local regulations. The personnel assessing safety must be able to recognize possible consequences and risks arising from non-conforming equipment.
All recurring safety and performance assurance tests must be performed under equal environmental conditions to be comparable.
Preventive Maintenance refers specifically to the series of tests required to make sure the measurement results are accurate. The accuracy and performance procedures are designed to be completed as specified in the following sections or when readings are in question.
For detailed instructions on the maintenance and cleaning of the monitor and its accessories, see Care and Cleaning, Using Batteries and Maintenance and Troubleshooting in the monitor's Instructions for Use.
The following terms and definitions are used throughout this chapter and taken from the international standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.
•Medical System: a medical electrical system is a combination of at least one medical electrical device and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.
•Patient Environment: any area in which intentional or unintentional contact can occur between the patient and parts of the medical system or between the patient and other persons who have had contact with parts of the medical system. The patient environment is defined anywhere within 1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.
•Separation Device/Transformer: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a medical system.
•Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to be connected to or integrated with flexible cables or cords, which can easily be moved from one place to another while connected to the power mains.
•Functional Connection: an electrical connection for transfer of signals and/or power.
25
3 Testing and Maintenance
•Tests: Safety or Performance Assurance test procedures which may consist of several steps.
Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements.
Tests |
|
|
Frequency |
|
|
|
|
Preventive |
NBP Performance |
Once every two years, or more |
|
Maintenance |
|
|
often if specified by local laws. |
|
Microstream CO2 Calibration1 |
Once a year or after 4000 hours |
|
|
|
|
of continuous use and following |
|
|
|
any instrument repairs or the |
|
|
|
replacement of any instrument |
|
|
|
parts. |
|
Tympanic Temperature Calibration |
Once a year. If the unit is |
|
|
|
|
dropped or damaged, check it |
|
|
|
and calibrate it before further |
|
|
|
use. |
Other Regular Tests |
Visual Inspection |
Before each use. |
|
|
Power On Test |
|
|
Performance |
ECG/Resp Performance |
Once every two years, or if you |
|
Assurance Tests |
ECG Out Sync Performance1,2 |
suspect the measurement is |
|
|
|
|
incorrect, except Mainstream |
|
ECG Sync Pulse Performance1,2 |
||
|
CO2 Accuracy Check, |
||
|
SpO2 Performance |
Sidestream CO2 Accuracy Check |
|
|
NBP Performance |
and Flow Check and Predictive |
|
|
Temperature Accuracy Check - |
||
|
Invasive Pressure Performance1,2 |
||
|
required once a year. |
||
|
Temperature Accuracy1,2 |
|
|
|
Predictive Temperature Accuracy |
|
|
|
Check |
|
|
|
Mainstream CO2 Accuracy Check1,2 |
|
|
|
Sidestream CO |
Accuracy Check and |
|
|
1,2 |
2 |
|
|
Flow Check |
|
|
|
Microstream CO2 Performance Test1 |
|
|
|
Nurse Call Relay Performance1 |
|
|
|
Power Loss Alarm Buzzer |
|
|
|
Performance |
|
|
|
MSL Assurance Test1,2 |
|
|
|
Mounting Integrity Test |
|
|
|
Battery Performance |
|
|
|
|
|
|
26
|
|
|
3 Testing and Maintenance |
|
|
|
|
|
|
Tests |
|
|
Frequency |
|
|
|
|
|
|
Safety |
Visual |
Visual Inspection |
After each service event |
|
Tests |
|
|
|
|
Electrical |
Protective Earth |
Once every two years and after |
|
|
|
|
|||
|
|
|
repairs where the power supply |
|
|
|
Equipment Leakage Current |
|
|
|
|
has been removed or replaced or |
|
|
|
|
Patient Leakage Current |
|
|
|
|
the monitor has been damaged |
|
|
|
|
|
|
|
|
|
|
by impact. |
|
|
|
System Test |
Once every two years |
|
|
|
|
|
|
1These tests do not apply for MP5T.
2These tests do not apply for MP5SC
This table tells you when to perform specific tests.The corresponding test procedures are described in the following sections All tests listed below must be performed on the monitor.
Service Event |
Tests Required |
(When performing... |
...Complete these tests) |
|
|
Installation |
|
|
|
Installation of a monitor in combination with a |
Perform Visual Inspection, Power On and System |
medical or non-medical device connected to the |
Tests |
same multiple socket outlet. |
|
|
|
Installation of a standalone monitor with no |
Perform Visual Inspection and Power On Test |
display connected to the video output |
|
Installation of a monitor with a medical display |
Perform Visual Inspection and Power On Test |
specified by Philips |
|
|
|
Installation of a monitor with an off-the-shelf |
Perform Visual Inspection, Power On and System |
display (non-compliant with IEC60601-1) |
Test |
|
|
Installation of a monitor with IntelliVue G1/ |
Perform Visual Inspection and Power On Tests |
G5, connected to separate mains sockets. |
|
Installation of monitor with IntelliVue |
Perform Visual Inspection, Power On and IIT |
Instrument Telemetry (IIT) |
communication test |
|
|
Installation of a monitor with IT equipment e.g. |
Perform Visual Inspection, Power On and System |
PC connected via a functional connection e.g. |
Tests |
Centronics or USB. |
|
|
|
Installation of monitor with IntelliVue 802.11 |
Perform Visual Inspection, Power On and |
Bedside Adapter |
IntelliVue 802.11 Bedside Adapter |
|
Communication Test |
|
|
Installation of a monitor with Short Range |
Perform Visual Inspection, Power On and SRR |
Radio (SRR) |
communication test |
Installation of networked monitor (LAN) |
Perform Visual Inspection and Power On Test |
|
|
27
3 Testing and Maintenance
Service Event |
Tests Required |
|
(When performing... |
...Complete these tests) |
|
|
|
|
Preventive Maintenance |
|
|
|
|
|
Preventive Maintenance* |
Perform preventive maintenance tests and |
|
|
procedures: |
|
|
• |
NBP calibration |
|
• |
Microstream CO2 calibration |
|
• |
Tympanic Temperature Calibration |
|
|
|
Other Regular Tests and Tasks |
|
|
|
|
|
Visual Inspection |
Perform Visual Inspection |
|
|
|
|
Power On Test |
Perform Power On test |
|
|
|
|
Repairs |
|
|
|
|
|
Repairs where the monitor has been damaged by |
Perform Visual Inspection, Power On, all Safety |
|
impact, liquid ingression, fire, short circuit or |
Tests and Full Performance Assurance Tests |
|
electrical surge. |
|
|
|
|
|
Repairs where the power supply, the mains |
Perform Visual Inspection, Power On, all Safety |
|
socket or an interface board is removed or |
Tests and Basic Performance Assurance Test |
|
replaced or the protective earth ground |
|
|
connection is disrupted. |
|
|
|
|
|
Repairs where the main board has been replaced. |
Perform Visual Inspection, Power On, Basic |
|
|
Performance Assurance Test and NBP Accuracy |
|
|
Test and Calibration. |
|
|
|
|
Repairs where the measurement block has been |
Perform Visual Inspection, Power On, all Safety |
|
removed or replaced |
Tests and Basic Performance Assurance Test. |
|
|
If a certain parameter seems suspicious, perform |
|
|
Full Performance Assurance Test for this |
|
|
parameter. |
|
|
|
|
Repairs where the NBP pump has been replaced |
Perform Visual Inspection, Power On, all Safety |
|
|
Tests, Basic Performance Assurance Test and NBP |
|
|
Performance Test and Calibration |
|
|
|
|
Repairs of IntelliVue Instrument Telemetry (IIT) |
Perform Visual Inspection, Power On Test Block |
|
Module |
and IIT communication test |
|
|
|
|
Repairs of IntelliVue 802.11 Bedside Adapter |
Perform Visual Inspection, Power On and |
|
|
IntelliVue 802.11 Bedside Adapter |
|
|
Communication Test |
|
|
|
|
Repairs of Short Range Radio (SRR) Interface |
Perform Visual Inspection, Power On and SRR |
|
|
Communication Test |
|
|
|
|
Repairs of the IntelliVue G1/G5 |
Perform Basic Performance Assurance Test. For |
|
|
further testing requirements, see IntelliVue G1/ |
|
|
G5 Service Guide |
|
|
|
|
Repairs where the Quick Mount has been |
Perform Mounting Integrity Test |
|
disassembled |
|
|
|
|
|
All other IntelliVue Monitoring System repairs |
Perform Visual Inspection, Power On Test and |
|
(except when power supply is removed) |
Basic Performance Assurance Test |
|
|
|
|
28
|
3 Testing and Maintenance |
|
|
Service Event |
Tests Required |
(When performing... |
...Complete these tests) |
|
|
Performance Assurance |
|
|
|
Basic Performance Assurance |
Perform basic performance assurance tests for the |
|
respective monitoring system component. |
|
|
Full Performance Assurance |
Perform all accuracy and performance test |
|
procedures listed in the following sections. If a |
|
particular measurement is in question, perform the |
|
measurement performance test only. |
|
|
Upgrades |
|
|
|
Software Upgrades |
Perform Visual Inspection, Power On Test and |
|
Basic Performance Assurance Test unless |
|
otherwise specified in the Upgrade Installation |
|
Notes shipped with the upgrade. |
|
|
Hardware Upgrades |
Perform Visual Inspection, Power On Test and |
|
Basic Performance Assurance Test unless |
|
otherwise specified in the Upgrade Installation |
|
Notes shipped with the upgrade. |
|
|
Hardware Upgrades where IntelliVue |
Perform Visual Inspection, Power On Test, Basic |
Instrument Telemetry (IIT) is installed |
Performance Assurance Test and IIT |
|
communication Test |
|
|
Hardware Upgrades where IntelliVue 802.11 |
Perform Visual Inspection, Power On Test, Basic |
Bedside Adapter is installed |
Performance Assurance Test and IntelliVue 802.11 |
|
Bedside Adapter Communication Test |
|
|
Hardware Upgrades where Short Range Radio |
Perform Visual Inspection, Power On Test, Basic |
(SRR) is installed |
Performance Assurance Test and SRR |
|
communication Test |
|
|
Installation of Interfaces or Hardware Upgrades |
Perform Visual Inspection, Power On Test, Basic |
where the power supply or parameter boards |
Performance Tests and all Safety Tests |
need to be removed. |
|
|
|
Combining or Exchanging System |
Perform the System Test for the respective system |
Components (non-medical equipment |
components |
connected to an IntelliVue monitor or medical |
|
system equipment operated on a multiple socket |
|
outlet) |
|
|
|
NOTE |
|
It is the responsibility of the facility operator or their designee to obtain reference values for recurring safety and system tests. These reference values are the results of the first test cycles after an installation. You may also purchase this service from Philips.
29
3 Testing and Maintenance
Summary of the recommended sequence of testing:
NOTE
If any single test fails, testing must be discontinued immediately and the device under test must be repaired or labeled as defective.
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.
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
30