IntelliVue MP2/X2
Service Guide
IntelliVue Patient Monitor
MP2/X2
Patient Monitoring
Part Number M3002-9301B 4535 641 12541
*M3002-9301B*
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Contents |
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1 Introduction |
9 |
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Who Should Use This Guide |
9 |
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How to Use This Guide |
9 |
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Responsibility of the Manufacturer |
10 |
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Passwords |
10 |
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Warnings and Cautions |
11 |
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2 Theory of Operation |
13 |
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Monitor Theory of Operation |
13 |
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System Boundaries |
14 |
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Hardware Building Blocks |
15 |
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Data Flow |
19 |
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How does the Support Tool Work with the Monitor |
22 |
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Monitor Software Block Diagram |
22 |
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Block Diagram Legend |
23 |
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3 Testing and Maintenance |
27 |
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Introduction |
27 |
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Terminology and Definitions |
28 |
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Recommended Frequency |
29 |
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When to Perform Tests |
30 |
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Testing Sequence |
34 |
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Visual Inspection |
35 |
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Before Each Use |
35 |
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After Each Service, Maintenance or Repair Event |
35 |
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Power On Test |
35 |
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Safety Tests |
36 |
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Warnings, Cautions, and Safety Precautions |
37 |
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Safety Test Procedures |
38 |
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System Test |
62 |
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What is a Medical Electrical System? |
62 |
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General Requirements for a System |
62 |
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System Example |
63 |
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System Installation Requirements |
64 |
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Required Protective Measures at System Installation |
65 |
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System Test Procedure |
75 |
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Preventive Maintenance Procedures |
76 |
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Noninvasive Blood Pressure Measurement Calibration |
76 |
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Performance Assurance Tests |
76 |
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Basic Performance Assurance Test |
76 |
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3
Full Performance Assurance Test |
77 |
ECG/Resp Performance Test |
77 |
ECG Sync Performance Test |
78 |
SpO2 Performance Test |
78 |
NBP PerformanceTest |
79 |
Invasive Pressure Performance Test |
81 |
Temperature Performance Test |
82 |
M3014A Capnography Extension Performance Tests |
82 |
Microstream CO2 Performance Test |
85 |
Cardiac Output Performance Test |
90 |
Power Loss Alarm Buzzer Performance Test (only if Multi-Port Nurse Call Connector Board is installed) |
92 |
IntelliVue 802.11 Bedside Adapter Communication Test |
92 |
IIT Communication Test |
93 |
Short Range Radio (SRR) Performance Test |
94 |
Reporting of Test Results |
95 |
Carrying Out and Reporting Tests |
95 |
Evaluation of Test Results |
97 |
Other Regular Tests |
98 |
Locking/Unlocking Touch Operation |
98 |
Battery Handling, Maintenance and Good Practices |
98 |
About the Battery |
98 |
Checking the Battery Status |
99 |
Battery Status on the Main Screen |
100 |
Battery Status Window |
101 |
Checking Battery Charge |
103 |
Replacing a Battery |
103 |
Optimizing Battery Performance |
104 |
Battery Safety Information |
108 |
After Installation, Testing or Repair |
108 |
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4 Troubleshooting |
109 |
Introduction |
109 |
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How To Use This Section |
109 |
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Who Should Perform Repairs |
109 |
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Replacement Level Supported |
110 |
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Software Revision Check |
110 |
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Software Compatibility Matrix |
110 |
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Compatibilty with MMS |
111 |
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Compatibility with Information Center |
111 |
Obtaining Replacement Parts |
111 |
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Troubleshooting Guide |
112 |
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Checks for Obvious Problems |
112 |
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Checks Before Opening the Instrument |
112 |
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Troubleshooting Tables |
114 |
4
Status Log |
130 |
List of Error Codes |
131 |
Troubleshooting with the Support Tool |
131 |
Troubleshooting the Individual Measurements or Applications |
131 |
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5 Repair and Disassembly |
133 |
Who Should Perform Repairs |
133 |
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Tools required |
133 |
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Removing the Battery |
134 |
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Removing the Handle |
134 |
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Removing the Side Cover |
135 |
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Removing the Display/Exchanging the SRR Board |
136 |
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Reassembly of the Display |
138 |
Removing the NBP Pump Assembly |
138 |
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Reassembling the NBP pump chassis |
140 |
Exchanging the NBP Pump |
142 |
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Exchanging the NBP Airguide / IIT or WLAN Assembly |
145 |
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Reassembly Procedure |
147 |
Exchanging the Loudspeaker |
150 |
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Reassembly Procedure |
151 |
Removing the Power Board |
152 |
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Reassembly Procedure |
154 |
Removing the ECG Sync Pulse Out Connector |
155 |
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Removing the Main Board |
157 |
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Removing the Rear Housing |
158 |
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Removing the Measurements |
160 |
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Exchanging the Main Housing |
161 |
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Exchanging the Silicon Pads |
162 |
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MMS Extensions - Exchanging the Top Cover, MSL Flex Cable and the Dual Link Bar |
165 |
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Exchange Procedures |
166 |
Disassembly Procedures for the M3015A MMS Extension (HW Rev. A) |
177 |
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Removing the Front Cover |
177 |
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Refit Procedures for the MMS Extension |
181 |
Smart Battery Charger LG1480 (M8043A) |
183 |
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Cleaning the Air Filter Mats |
183 |
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Replacing the Fan |
183 |
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6 Parts |
187 |
Exchange and Replacement Parts |
189 |
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MMS Extension Parts (M3012A, M3014A, M3015A and M3016A) |
192 |
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MMS Extension Part Numbers - Release Mechanisms |
192 |
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MMS Extension Part Numbers - Top Cover, Flex Cable and Link Bar |
193 |
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MMS Extension Part Numbers - Front Bezels |
193 |
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Exchange Parts List |
195 |
5
Smart Battery Charger Part Numbers |
197 |
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7 Installation Instructions |
199 |
Out-Of-Hospital Transport - Standards Compliance |
199 |
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Electromagnetic Interference (SRR) |
201 |
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Installation Checklist |
201 |
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Unpacking and Checking the Shipment |
201 |
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Initial Inspection |
202 |
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Claims for Damage |
202 |
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Repacking |
202 |
Mounting the Monitor |
203 |
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Mounting the Monitor using the Anti-slip Pad |
203 |
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Mounting the Monitor using the MMS Mount and Mounting Clamp |
205 |
Connecting the Monitor to AC Mains |
209 |
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Host Monitor as Power Source |
209 |
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External Power Supply M8023A(Standard with MP2, Optional with X2) |
210 |
Checking Out the Monitor |
211 |
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Configuration Tasks |
212 |
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Checking Country-Specific Default Settings |
212 |
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Setting Altitude, Line Frequency, ECG Cable Colors and Height & Weight Units |
213 |
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Configuring the Equipment Label |
213 |
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Configuring IP Address, Subnet Mask and Default Gateway |
214 |
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Configuration Settings for CSCN Routed Bedside Monitors (RBM) |
214 |
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Configuring Routed Bedside Monitors Support |
215 |
Setting the Date and Time |
215 |
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Handing Over the Monitor |
216 |
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Philips Clinical Network (Wired) |
216 |
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Philips IntelliVue Information Center |
216 |
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IntelliVue Instrument Telemetry (IIT) |
217 |
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Short Range Radio |
218 |
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Configuring SRR Channels |
218 |
ECG Sync Pulse |
221 |
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MSL Cable Termination |
222 |
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8 Site Preparation |
225 |
Introduction |
225 |
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Site Planning |
225 |
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Roles & Responsibilities |
226 |
Monitor Site Requirements |
228 |
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Space Requirements |
228 |
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Environmental Requirements |
228 |
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Electrical and Safety Requirements (Customer or Philips) |
229 |
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Connecting Non-Medical Devices |
230 |
Philips Medical LAN |
230 |
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9 MP2/X2 Product Structure |
231 |
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Upgrades |
238 |
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10 |
Default Settings Appendix |
241 |
Country-Specific Default Settings |
241 |
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11 |
Index |
251 |
7
8
1
This Service Guide contains technical details for the IntelliVue MP2 Patient Monitor and the IntelliVue X2.
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.
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 |
Responsibility of the Manufacturer |
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.
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.
10
Warnings and Cautions |
1 Introduction |
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
1 Introduction |
Warnings and Cautions |
12
2
The IntelliVue MP2/X2 Patient Monitor:
-displays real-time data
-alarms in the case of patient or equipment problems
-offers limited data storage and retrieval (trending)
-interfaces to the Philips Clinical Network and other equipment
The monitor can be configured with various different measurement and interface capabilities.
NOTE
The following descriptions may vary depending on the monitor option purchased.
13
2 Theory of Operation |
Monitor Theory of Operation |
The following diagram discusses specific boundaries within the overall system with respect to their openness and real-time requirements:
System Boundaries
Measurement connections
Built-in measurement block
Philips Clinical Network (wired LAN)
connects multiple patient monitors, information centers, application servers; closed system, only Philips qualified products (tested and with regulatory approval) are connected, Philips is responsible for guaranteed real-time functionality and performance
Philips Clinical Network (wireless)
like Philips Clinical Network (wired) LAN, however due to current wireless technologies available it has reduced bandwidth, longer latencies, reduced functionality
Hospital LAN, Internet
Standard Network, not under Philips control, no guaranteed service, no real-time requirements
14
Monitor Theory of Operation |
2 Theory of Operation |
The following hardware building blocks make up the monitoring system:
MP2/X2 Hardware Building Blocks
The MP2 monitor:
-integrates the display and processing unit into a single package
-uses a 3.5” color TFT display
-uses the Touchscreen as input device
-integrates the measurement block with optional parameter sets
-has an internal battery
-standalone patient monitor
15
2 Theory of Operation |
Monitor Theory of Operation |
The IntelliVue X2:
-integrates the display and processing unit into a single package
-uses a 3.5” color TFT display
-uses the Touchscreen as input device
-integrates the measurement block with optional parameter sets
-has an internal battery
-can be used as a Multi-Measurement Module or as a standalone patient monitor
-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.
-Integrated Short Range Radio (SRR)
Power Distribution Architecture
16
Monitor Theory of Operation |
2 Theory of Operation |
The DC/DC converter transforms the DC power (36-60 V DC range) coming from the MSL plug into a 16 V DC source and isolates the monitoring system from the DC MSL.
The 16V DC is distributed via the Power Board to the battery charging circuit and to the main board.
The power is used to charge the battery and supply the monitoring system. As soon as the DC power source is disconnected, the battery starts and keeps the system powered (battery mode).
The main board contains power supply circuits, which convert the 16 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 16 V DC system power or by the battery power and converted to 3.6 V DC.
The CPU board has an MPC852 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. The main board contains additional video hardware.
The CPU provides a LAN interface to connect to the Philips Clinical Network (Ethernet).
The LAN interface on the Measurement Link (MSL) is used as the network interface.
17
2 Theory of Operation |
Monitor Theory of Operation |
M3012A, M3014A, M3015A, M3016A MMS Extensions
NOTE
The MMS Extensions are not supported if the IntelliVue MP2/X2 is powered from the internal battery. Although they can still be attached, they will not function in this case.
18
Monitor Theory of Operation |
2 Theory of Operation |
The following diagram shows how data is passed through the monitoring system. The individual stages of data flow are explained below.
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Display |
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and User |
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Data |
Data |
Interface |
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Applications |
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Acquisition |
Provider |
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Service |
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Persistent |
Data |
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Data |
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Output |
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Storage |
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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 the monitor. Software modules dedicated to such specific devices convert the data received from an external device to the format used internally.
-Server systems on the Philips Clinical Network
To enable networked applications, data can be acquired from server systems attached to the Philips Clinical Network, for example a Philips Information Center
19
2 Theory of Operation |
Monitor Theory of Operation |
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.
20
Monitor Theory of Operation |
2 Theory of Operation |
The MP2/X2 communicates 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 X2 to the host monitor (for example measurement signal data) and the data flow from the host monitor to an X2 (for example to feed data to a recorder module).
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.
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.
For plug and play operation, the monitoring system uses the standard BootP protocol to automatically acquire a network address.
21
2 Theory of Operation |
Monitor Theory of Operation |
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.
The figure below 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.
Functional Block Diagram
22
Monitor Theory of Operation 2 Theory of Operation
Functional Block |
Description |
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Services |
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Operating System |
The Operating System (OS) provides a layer of isolation between the specific |
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hardware implementation and the application software. The OS performs system |
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checks and allocates resources to ensure safe operation when the system is first |
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started. This includes internal self-tests on several hardware modules and |
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configuration checks for validity of configuration with the operating software. |
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During normal operation, the OS continues to run checks on system integrity. If |
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error conditions are detected the OS will halt monitoring operations and inform |
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the operator about the error condition. |
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System Services |
The System Services provide generic common system services. |
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In particular: |
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They use a real-time clock component to track time. They synchronize to |
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network time sources and verify the accuracy of the system time information. |
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They are also responsible for managing persistent user configuration data for all |
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Measurement parameters and IntelliVue Patient Monitoring System software |
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modules. User configuration data is stored in a non-volatile read/write storage |
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device |
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Applications |
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Reports |
The Reports Service retrieves current and stored physiological data and status |
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data to format reports for printing paper documentation. Examples of supported |
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reports: |
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Vital Signs Report |
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Graphical Trend Report |
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Event Review Report |
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Event Episode Report |
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- ECG Report (12 Lead/Multi-Lead) |
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Test Report |
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The Reports service generates report data which can be printed on a central |
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printer. |
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23
2 Theory of Operation |
Monitor Theory of Operation |
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Functional Block |
Description |
Alarm |
The Alarm Service contains logic that prioritizes alarm conditions that are |
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generated by IntelliVue Patient Monitoring System software modules. Visual |
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alarm signals (messages) are displayed at the top of the IntelliVue Patient |
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Monitoring System display and alarm sounds are generated by a loudspeaker. |
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Alarm conditions may be generated when a physiological parameter exceeds |
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preselected alarm limits or when a physiological parameter or any other software |
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module reports an inoperative status (technical alarm, for example, the ECG |
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leads may have fallen off the patient). The Alarm service manages the alarm |
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inactivation states, for example suspension of alarms, silencing of alarms, and |
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alarm reminder. Alarm signals may also be configured as latching (alarm signals |
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are issued until they are acknowledged by the operator, even when the alarm |
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condition is no longer true). The Alarm service controls the visual alarm signals |
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(alarm lamps). |
Trend |
The Trend service stores the sample values of physiological data and status data |
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with a resolution of 12 seconds, 1 minute or 5 minutes for a period of up to 48 |
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hours. The data is kept in battery buffered read/write storage and flash memory |
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devices to be preserved across power failures. The stored data is protected via |
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consistency checks and checksums. When a new patient is admitted, the trend |
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database erases all data of the previous patient. |
ADT |
The ADT (Admit/Discharge/Transmit) service maintains the patient |
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demographics information. The operator may admit a new patient, discharge the |
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old patient and enter or modify the patient demographics. |
Calc Param |
The Calc Param (Calculated Parameters) application performs calculations on |
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physiological numerical values to derive calculated parameters like Temperature |
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Difference. |
Interface Managers |
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MDSE |
The MDSE (Medical Data Service Element) Interface Manager is responsible |
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for the exchange of real-time data between the IntelliVue Patient Monitoring |
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System display unit and the Measurement parameters and other devices attached |
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to the network. MDSE establishes and maintains a data communication link |
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between the devices. It provides configuration information about the remote |
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device to applications in the local device and it allows the exchange of |
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measurement data and status information between the devices. |
Printer |
The Printer Interface Manager provides a high level interface to a printer. It |
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provides means to: |
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- establish a connection to the printer |
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- transfer data to the printer |
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- get status of the printer |
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- close connection to the printer |
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The Printer Interface Manager also supervises the connection to the printer and |
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whether the printer accepts data (for example paper out). The Printer Interface |
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Manager notifies the operator in such cases. |
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24
Monitor Theory of Operation |
2 Theory of Operation |
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Functional Block |
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Description |
Display & Operator |
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The Display and Operator Interface Manager performs the following tasks: |
Interface |
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- Screen presentation of real-time and stored physiological measurement data, |
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alarm condition data and status information received from the MDSE |
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interface manager, the Alarm service or other IntelliVue Patient Monitoring |
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System modules |
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- Screen presentation of operating controls (control windows) |
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- Processing of operating control commands received from HIF Control |
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interface. The module verifies and interprets the received commands and |
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forwards them to other software modules of the IntelliVue Patient |
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Monitoring System display unit or measurement parameters. |
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- Sound generation (issues audible alarm signals and generates audible |
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information signals, for example QRS and SpO2 tones, operator audible |
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feedback) |
Interfaces |
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LAN |
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The LAN interface implements the physical layer of IEEE 802.3. The LAN |
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interface performs Manchester encoding/decoding, receive clock recovery, |
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transmit pulse shaping, jabber, link integrity testing, reverse polarity |
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detection/correction, electrical isolation, and ESD protection. Electronically |
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separated interfaces are used for communication to the Measurement parameters |
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and to the network. |
Display Controller |
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The Display Controller Interface consists of a video controller, video RAM and |
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the controlling software. The Display Controller interface processes the high |
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level display commands (character and graphic generation, wave drawing) and |
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translates them into pixels, which are written into the video RAM where the |
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video controller chip generates the video synchronization signals and the pixel |
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stream for the Color LCD Display. |
HIF Control |
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The HIF (Human Interface Control) interface scans the Human Interface devices |
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for operator controls (Touch Screen), formats the collected data and sends it to |
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the display and Operating Interface. |
Sync Out (ECG) |
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A pulse signal is provided on the Sync Out connector to allow synchronisation |
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with other medical devices. |
IIT |
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The built-in IIT module allows operation of the MP2/X2 monitors within |
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IntelliVue Instrument Telemetry Infrastructure. |
WLAN |
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The built-in WLAN interface allows wireless operation of the X2/MP2 monitors |
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with the IntelliVue 802.11 Bedside Adapter |
SRR |
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The built-in SRR interface allows wireless communication of the MP2/X2 |
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monitors with an IntelliVue Instrument Telemetry Transceiver. |
MSL |
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All components of the monitoring system communicate using an IEEE802.3/ |
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Ethernet LAN in the Measurement Link (MSL). This network is used to |
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distribute data between the components |
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25
3
This chapter provides a checklist of the testing and maintenance procedures to ensure the performance and safety of the monitor and the MMS Extensions. For testing of the host monitor and the Flexible Module Rack (FMS), see the Service Guide of the host 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.
Testing of the MP2/X2 may be performed either on the MP2/X2 (with external power supply) directly or (for the X2) on the host monitor.
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.
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3 Testing and Maintenance |
Terminology and Definitions |
Terminology and Definitions
The following terms and definitions are used throughout this chapter and taken from the international standards IEC 60601-1, IEC 60601-1-1 and IEC 62353.
-Medical System: a medical electrical system is a combination of at least one medical electrical device and other electrical equipment, interconnected by functional connection or use of a multiple portable socket-outlet.
-Patient Vicinity: any area in which intentional or unintentional contact can occur between the patient and parts of the medical system or between the patient and other persons who have had contact with parts of the medical system. The patient vicinity is defined anywhere within 1.5m (5 feet) of the perimeter of the patient's bed and 2.5m (8.2 feet) from the floor.
-Separation Device/Transformer: a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a medical system.
-Multiple Portable Socket-Outlet: a combination of two or more socket-outlets intended to be connected to or integrated with flexible cables or cords, which can easily be moved from one place to another while connected to the power mains.
-Functional Connection: an electrical connection for transfer of signals and/or power.
-Tests: Safety or Performance Assurance test procedures which may consist of several steps.
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Recommended Frequency |
3 Testing and Maintenance |
Recommended Frequency
Perform the procedures as indicated in the suggested testing timetable. These timetable recommendations do not supersede local requirements.
Table 1: Suggested Testing Timetable
Tests
NBP Performance
Preventive Maintenance*
Microstream CO2 Calibration
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Other Regular Tests |
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Visual Inspection |
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Power On Test |
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Performance Assurance |
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ECG/Resp Performance |
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ECG Sync Pulse Performance |
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Tests |
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SpO2 Performance |
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NBP Performance |
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Invasive Pressure Performance |
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Temperature Accuracy |
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M3014A Capnography Extension |
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Performance Tests |
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Microstream CO2 Performance Test |
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C.O. Performance Test |
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Safety |
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Visual |
Visual Inspection |
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Tests |
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Electrical |
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Protective Earth |
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Equipment Leakage Current |
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Patient Leakage Current |
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System Test |
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Frequency
Once every two years, or more often if 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.
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.
After each 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.
Once every two years
*M3015A with the old hardware Rev. A (i.e. Serial No. DE020xxxxx) also require the CO2 pump/CO2 scrubber replacement procedure. This is required every three years or after 15000 operating hours.
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3 Testing and Maintenance |
When to Perform Tests |
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 and its host monitor.
When to perform tests
Service Event |
Tests Required |
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(When performing... |
...Complete these tests) |
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Installation |
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Installation of a monitor in combination with |
Perform Visual Inspection, Power On and |
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a medical or non-medical device connected to |
System Tests |
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the same multiple socket outlet. |
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Installation of monitor with IntelliVue |
Perform Visual Inspection, Power On and IIT |
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Instrument Telemetry (IIT) |
communication test |
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Installation of monitor with IntelliVue |
Perform Visual Inspection, Power On and |
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802.11 Bedside Adapter |
IntelliVue 802.11 Bedside Adapter |
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Communication Test |
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Installation of a monitor with Short Range |
Perform Visual Inspection, Power On and SRR |
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Radio (SRR) |
communication test |
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Installation of networked monitor (LAN) |
Perform Visual Inspection and Power On Test |
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Preventive Maintenance |
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Preventive Maintenance* |
Perform preventive maintenance tests and |
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procedures: |
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NBP calibration |
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Microstream CO2 calibration |
Other Regular Tests and Tasks |
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Visual Inspection |
Perform Visual Inspection test block |
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