Nellcor PM-1000N User manual
Service Manual
Nellcor™
Bedside Respiratory Patient Monitoring System
COVIDIEN, COVIDIEN with logo, the Covidien logo and positive results for life are U.S. and
internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company.
©2013 Covidien. All rights reserved.
Microsoft and Windows EC are registered trademarks of Microsoft Corporation in the United
States and other countries.
The information contained in this manual is the sole property of Covidien and may not be
duplicated without permission. This manual may be revised or replaced by Covidien at any time
and without notice. It is the responsibility of the reader to have the most current applicable
version of this manual. If in doubt, contact Covidien Technical Services.
While the information set forth herein is believed to be accurate, it is not a substitute for the
exercise of professional judgment.
The equipment and software should only be operated and serviced by trained professionals.
Covidien’s sole responsibility with respect to the equipment and software, and its use, is as
stated in the limited warranty provided.
Nothing in this manual shall limit or restrict in any way Covidien’s right to revise or otherwise
change or modify the equipment and software described herein, without notice. In the
absence of an express, written agreement to the contrary, Covidien has no obligation to
furnish any such revisions, changes, or modifications to the owner or user of the equipment
and software described herein.
Table of Contents
1 Introduction
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.2 Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.3 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.3.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
1.4 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . 1-5
1.4.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.4.2 On-Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.5 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
1.6 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
2 Product Specifications
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.2 Physical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3 Electrical Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3.1 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.3.2 Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.3.3 Rating of Nurse Call Relay . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.4 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.4.1 Operating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.4.2 Transport and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.5 Sensor Accuracy and Ranges . . . . . . . . . . . . . . . . . . . . . . 2-4
2.6 Sound Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.7 Product Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
2.8 Manufacturer’s Declaration and Guidance . . . . . . . . . . . 2-6
2.8.1 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . 2-6
2.8.2 Ground Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
2.8.3 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
3 Theory of Operations
3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 Block Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.3 Theoretical Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
3.4 Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
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3.5 Functional Testers and Patient Simulators . . . . . . . . . . . 3-3
3.6 Unique Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.6.1 Functional versus Fractional Saturation . . . . . . . . . . . . . . . . . 3-4
3.6.2 Measured versus Calculated Saturation . . . . . . . . . . . . . . . . . 3-4
3.6.3 Data Update Period, Data Averaging, and Signal Processing . 3-5
3.7 System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
3.7.1 Nellcor™ Sensor Technology . . . . . . . . . . . . . . . . . . . . . . . . 3-6
3.7.2 SatSeconds™ Alarm Management Parameter . . . . . . . . . . . . 3-7
3.7.3 OxiMax SPD™ Alert Parameter . . . . . . . . . . . . . . . . . . . . . . 3-11
3.7.4 Pulse Rate Delay Alarm Management Parameter . . . . . . . . . 3-13
4 Product Overview
4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.2 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.3 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.4 List of Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.5 Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
4.6 Product Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.6.1 Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.6.2 Monitoring Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
4.6.3 Rear Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.7 Labeling Symbology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
5 Installation
5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.3 Product Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.3.1 Mounting Options and Transport Considerations . . . . . . . . . 5-3
5.3.2 Connection to an AC Power Source . . . . . . . . . . . . . . . . . . . 5-3
5.3.3 Battery Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
5.3.4 Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
5.3.5 Battery Power Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
5.4 Connection to Nellcor™ Sensors . . . . . . . . . . . . . . . . . . . 5-7
6 Operation
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.2.1 AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
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6.2.2 Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
6.2.3 Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.2.4 System Resets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
6.2.5 Automatic Shutdown and Power Off . . . . . . . . . . . . . . . . . . 6-6
6.3 Nellcor™ Sensor Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.3.1 Sensor Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
6.3.2 Sensor Detection Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
6.4 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
6.4.1 Default Monitoring Screen and Trend Data . . . . . . . . . . . . . . 6-9
6.4.2 Status Messages and Alarms in the Monitoring Status Field . 6-9
6.4.3 Alarm Management and Status Messages . . . . . . . . . . . . . . 6-10
6.4.4 Audible Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . 6-13
6.4.5 Visual Alarm Management . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
6.4.6 HELP Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
6.5 Service Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
6.5.1 Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
6.5.2 Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
6.5.3 Logs Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
6.5.4 Covidien Service Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32
6.5.5 Parameter Activation Menu . . . . . . . . . . . . . . . . . . . . . . . . 6-33
6.5.6 About Monitor Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
7 Trend Data Access
7.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2 Trend Data Management . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.2.1 Trend Data Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.3 Data Port Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
7.3.2 Typical Equipment Used for Connectivity . . . . . . . . . . . . . . . 7-3
7.3.3 Data Port Configuration Information . . . . . . . . . . . . . . . . . . . 7-3
7.3.4 Data Port Communications . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
7.4 Using the Nurse Call Interface . . . . . . . . . . . . . . . . . . . . 7-14
7.4.1 Nurse Call Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
7.4.2 Setting Nurse Call RS-232 Polarity . . . . . . . . . . . . . . . . . . . . 7-16
7.5 Calculating the Analog Voltage Output . . . . . . . . . . . . 7-17
8 Performance Considerations
8.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2 Oximetry Considerations . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
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8.2.1 Monitoring System Constraints . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.2.2 Nellcor™ Sensor Performance Considerations . . . . . . . . . . . . 8-1
8.3 Patient Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
8.4 Reducing EMI (Electromagnetic Interference) . . . . . . . . . 8-4
9 Product Maintenance
9.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.2 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.3 Periodic Safety Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
9.4 Service and Upgrades . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.5 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
9.5.1 Monitoring System Transport and Storage . . . . . . . . . . . . . . 9-2
9.5.2 Removed Battery Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
10 Modification and Testing
10.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
10.2 Setting Institutional Defaults . . . . . . . . . . . . . . . . . . . . . 10-5
10.3 Performance Verification . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.3.2 Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
10.4 Safety Testing Standards . . . . . . . . . . . . . . . . . . . . . . . . 10-9
10.5 Battery Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
10.5.1 Battery Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
10.5.2 Battery Charge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10
10.6 Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
10.6.1 Power-On Defaults and Alarm Ranges . . . . . . . . . . . . . . . 10-11
10.6.2 Operational Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17
10.6.3 Overall Performance Check . . . . . . . . . . . . . . . . . . . . . . . . 10-22
10.6.4 Pulse Oximetry Functional Tests . . . . . . . . . . . . . . . . . . . . 10-24
10.6.5 Setting Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-40
10.7 Test Data Sheet Form . . . . . . . . . . . . . . . . . . . . . . . . . . 10-42
10.8 Monitoring Screen Calibration . . . . . . . . . . . . . . . . . . . 10-44
10.9 Software and Firmware Upgrades . . . . . . . . . . . . . . . . 10-45
11 Troubleshooting
11.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
11.2 System Condition Categories . . . . . . . . . . . . . . . . . . . . . 11-1
11.3 User Prompts and Messages . . . . . . . . . . . . . . . . . . . . . . 11-4
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11.4 Alarms and Error Conditions . . . . . . . . . . . . . . . . . . . . . . 11-4
11.4.1 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4
11.4.2 Correctable error conditions . . . . . . . . . . . . . . . . . . . . . . . . 11-9
11.5 Power Failure Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-11
11.6 Monitoring Screen Issues . . . . . . . . . . . . . . . . . . . . . . . 11-13
11.7 Alarm Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
11.8 Communication Issues . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
11.9 Operational Performance Issues . . . . . . . . . . . . . . . . . . 11-17
11.10 Hardware Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-17
11.11 System Errors and Software issues . . . . . . . . . . . . . . . 11-19
11.12 Non-correctable Failures . . . . . . . . . . . . . . . . . . . . . . . . 11-19
11.13 Product Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-20
12 Repair
12.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
12.2 Spare Parts List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
12.3 Repair Prerequisites and Required Equipment . . . . . . . 12-5
12.4 Basic Preventive Maintenance . . . . . . . . . . . . . . . . . . . . 12-6
12.4.1 Fuse Removal and Replacement . . . . . . . . . . . . . . . . . . . . . 12-7
12.4.2 Battery or Battery Access Door Replacement . . . . . . . . . . . . 12-7
12.4.3 Rubber Feet Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8
12.5 Chassis Disassembly and Reassembly . . . . . . . . . . . . . 12-10
12.5.1 Parameter Module Replacement . . . . . . . . . . . . . . . . . . . . 12-10
12.5.2 Monitoring System Chassis Disassembly . . . . . . . . . . . . . . 12-17
12.5.3 Monitoring System Chassis Reassembly . . . . . . . . . . . . . . . 12-20
12.6 Power Components Replacement . . . . . . . . . . . . . . . . 12-21
12.6.1 Power Entry Module (PEM) Replacement . . . . . . . . . . . . . . 12-22
12.6.2 Right Power Cable Assembly Replacement . . . . . . . . . . . . 12-22
12.6.3 Battery Components Replacement . . . . . . . . . . . . . . . . . . 12-24
12.6.4 Left Power Cable Assembly Replacement . . . . . . . . . . . . . 12-31
12.7 Front Panel Components Replacement . . . . . . . . . . . . 12-32
12.7.1 Main PCB Components Replacement . . . . . . . . . . . . . . . . 12-33
12.7.2 LCD Assembly with Overlay Replacement . . . . . . . . . . . . . 12-39
12.8 Return Authorization and Shipment . . . . . . . . . . . . . . 12-41
12.8.1 General Instructions for Return . . . . . . . . . . . . . . . . . . . . . 12-41
12.8.2 Repackage in Original Carton . . . . . . . . . . . . . . . . . . . . . . 12-42
12.8.3 Repackage in an Alternate Carton . . . . . . . . . . . . . . . . . . 12-43
Index
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Page Left Intentionally Blank
vi
List of Tables
Table1-1. Safety Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Table2-1. Nellcor™ Sensor Accuracy and Ranges . . . . . . . . . . . . . . . . . . . . . . . 2-4
Table2-2. Nellcor™ Sensor Operating Range and Power Dissipation . . . . . 2-5
Table2-3. Sound Pressure in Decibels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Table2-4. Frequency Band, Output Power, and Modulation Type . . . . . . . 2-6
Table2-5. Electromagnetic Emissions Guidelines and Compliance . . . . . . 2-7
Table2-6. Electromagnetic Immunity Guidelines and Compliance . . . . . . 2-8
Table2-7. Recommended Separation Distance Calculations . . . . . . . . . . . . 2-9
Table2-8. Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . 2-10
Table2-9. Sensor and Cable Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Table2-10. Earth and Enclosure Leakage Current Specifications . . . . . . . . . 2-12
Table2-11. Patient Applied and Patient Isolation Risk Current . . . . . . . . . . . 2-13
Table4-1. Typical Packing List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Table4-2. Labeling Symbols and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Table6-1. Battery Power Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Table6-2. Possible User Interface Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Table6-3. Possible Alarm Management Settings. . . . . . . . . . . . . . . . . . . . . . . 6-17
Table6-4. Possible Data Interface Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Table6-5. Possible Service Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
Table7-1. Input and Output Configuration Options . . . . . . . . . . . . . . . . . . . . 7-2
Table7-2. Sample Equipment Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Table7-3. DB-15 Signal Pinouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Table7-4. RJ-45 Signal Pinouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Table7-5. USB Signal Pinouts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Table7-6. Network Configuration Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Table7-7. Nurse Call Relay Pin States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Table7-8. Analog Pinouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17
Table10-1. Possible User Interface Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Table10-2. Possible Alarm Management Settings. . . . . . . . . . . . . . . . . . . . . . . 10-3
Table10-3. Possible Data Interface and Service Settings . . . . . . . . . . . . . . . . 10-4
Table10-4. Equipment and Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Table10-5. Functional Tests Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-26
Table10-6. Performance and Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . .10-42
Table10-7. Electrical Safety Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-43
Table11-1. Common User Prompts and Messages . . . . . . . . . . . . . . . . . . . . . . 11-4
Table11-2. Initial Alarm Priority for Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5
Table11-3. Common Correctable Problems and Resolutions . . . . . . . . . . . . 11-9
Table11-4. Power Failure Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-11
Service Manual vii
Table11-5. Monitoring Screen Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-13
Table11-6. Alarm Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-14
Table11-7. Common Prompts and Error Messages. . . . . . . . . . . . . . . . . . . . .11-16
Table11-8. Common Operational Performance Issues . . . . . . . . . . . . . . . . .11-17
Table11-9. Common Prompts and Error Messages. . . . . . . . . . . . . . . . . . . . .11-17
Table12-1. Available Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Table12-2. Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-6
Table12-3. Main PCB Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-19
Table12-4. Main PCB Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12-33
viii Service Manual
List of Figures
Figure 3-1. Block Diagram ............................................................................................. 3-1
Figure 3-2. Oxyhemoglobin Dissociation Curve ................................................... 3-5
Figure 3-3. Series of SpO2 Events ................................................................................ 3-7
Figure 3-4. First SpO2 Event: No SatSeconds Alarm ............................................. 3-8
Figure 3-5. Second SpO2 Event: No SatSeconds Alarm ......................................3-9
Figure 3-6. Third SpO2 Event: Triggers SatSeconds Alarm ..............................3-10
Figure 3-7. Clinically Significant Desaturation Patterns ...................................3-12
Figure 4-1. Front Panel ................................................................................................... 4-3
Figure 4-2. Sample Monitoring Screen Elements ................................................. 4-4
Figure 4-3. Rear Panel ..................................................................................................... 4-6
Figure 5-1. Sensor Cable insertion into Interface Cable .................................... 5-7
Figure 6-1. Sample POST Splash Screen ................................................................. 6-6
Figure 6-2. Sensor Type Message ............................................................................... 6-8
Figure 6-3. Default Monitoring Screen Layout ...................................................... 6-9
Figure 6-4. Sample user prompt message: READY ...........................................6-11
Figure 6-5. Sample status message: MONITORING ...........................................6-11
Figure 6-6. High priority alarm: BATTERY CRITICALLY LOW ..........................6-11
Figure 6-7. Medium priority alarm: SpO2 LOW ....................................................6-11
Figure 6-8. Low priority alarm: SENSOR OFF ........................................................6-12
Figure 6-9. Sample Alarm Limit Violations ............................................................6-13
Figure 6-10. Prompt to Enter SERVICE MODE .........................................................6-19
Figure 6-11. Default Monitoring Screen Layout ....................................................6-24
Figure 7-1. DB-15 Pin Layout ....................................................................................... 7-5
Figure 7-2. RJ-45 Receptacle ........................................................................................ 7-7
Figure 7-3. RJ-45 Pin Layout ......................................................................................... 7-7
Figure 7-4. USB Pin Layout ............................................................................................ 7-8
Figure 7-5. New Network Connection Windows ................................................7-11
Figure 7-6. New Network Connection Windows ................................................7-12
Figure 7-7. Nurse Call Polarity Screen .....................................................................7-16
Figure 10-1. Prompt to Enter SERVICE MODE .........................................................10-5
Figure 10-2. Sample: Configuring Alarms ............................................................. 10-18
Figure 10-3. Sample: Configuring Alarms with Silenced Alarm .................... 10-19
Figure 10-4. Sensor Identification ............................................................................ 10-24
Figure 10-5. SRC-MAX Functional Tester ..............................................................10-25
Figure 10-6. BPM Test: BPM 60 and SpO2 75 ........................................................ 10-27
Figure 10-7. BPM Test: BPM 200 and SpO
Figure 10-8. SpO2 Test: SpO2 75, BPM 60 ..............................................................10-29
2 75 ..................................................... 10-28
Service Manual ix
Figure 10-9. SpO2 Test: SpO2 90, BPM 60 ..............................................................10-30
Figure 10-10. MOD Test: BPM 60, SpO2 75, and MOD Low ............................... 10-31
Figure 10-11. MOD Test: BPM 60, SpO
Figure 10-12. MOD Test: BPM 200, SpO
2 75, and MOD High .............................. 10-32
2 75, and MOD High ............................ 10-33
Figure 10-13. MOD Test: BPM 60, SpO2 90, and MOD High .............................. 10-34
Figure 10-14. LIGHT Test: BPM 60, SpO2 75, MOD low, Light low ................... 10-35
Figure 10-15. LIGHT Test: BPM 60, SpO2 75, MOD low, Light High ................10-36
Figure 10-16. LIGHT Test: BPM 200, SpO2 75, MOD low, Light High ..............10-37
Figure 10-17. LIGHT Test: BPM 60, SpO2 90, MOD low, Light High ................10-38
Figure 10-18. LIGHT Test: BPM 60, SpO2 90, MOD High, Light High .............. 10-39
Figure 10-19. Initial Calibration Screen .................................................................... 10-44
Figure 11-1. Ready Prompt ...........................................................................................11-2
Figure 11-2. Sensor Disconnected Message and Help Screen .........................11-2
Figure 11-3. Stacked Alarm/Alerts ..............................................................................11-3
Figure 11-4. Sample Speaker Failure Message .......................................................11-8
Figure 11-5. System Error ............................................................................................ 11-19
Figure 12-1. Exploded View of Removable Components ..................................12-3
Figure 12-2. Exploded View of Internal Components .........................................12-4
Figure 12-3. External Fuse Removal ...........................................................................12-7
Figure 12-4. Battery Removal .......................................................................................12-8
Figure 12-5. Rubber Feet Replacement ....................................................................12-9
Figure 12-6. Parameter Module Screw Removal ................................................ 12-11
Figure 12-7. Parameter Module Tab Release ....................................................... 12-12
Figure 12-8. Parameter Module Assembly Removal ......................................... 12-12
Figure 12-9. Parameter Module Disassembly ...................................................... 12-14
Figure 12-10. Parameter Board PCB and Oximetry Module Removal .......... 12-16
Figure 12-11. Corner Chassis Screws Removal ...................................................... 12-18
Figure 12-12. Initial Chassis Disassembly ................................................................ 12-20
Figure 12-13. Right Power Cable Assembly Replacement ................................ 12-23
Figure 12-14. Battery Cradle Removal ...................................................................... 12-25
Figure 12-15. Power Supply PCB Removal .............................................................. 12-27
Figure 12-16. Battery Interconnect PCB Removal ............................................... 12-29
Figure 12-17. Cooling Fan Removal .......................................................................... 12-30
Figure 12-18. Left Power Cable Assembly Replacement ................................... 12-31
Figure 12-19. Main PCB Connectors .......................................................................... 12-34
Figure 12-20. Antennae PCB and UFL Connectors Removal ............................ 12-36
Figure 12-21. Single Board Computer (SBC) Removal ........................................ 12-37
Figure 12-22. LCD Assembly Removal ...................................................................... 12-40
Figure 12-23. Components to Repackage in Original Carton .......................... 12-42
x Service Manual
1 Introduction
1.1 Overview
This manual, for use by qualified personnel only, contains instructions for
servicing, testing, and maintaining the Nellcor™ Bedside Respiratory Patient
Monitoring System.
This manual applies to the following products:
GR101704
GR101704-RR
PM1000N
PM1000N-RR
1.2 Intended Audience
This manual provides information to professionals acting as trained and qualified service technicians in a hospital or hospital-type setting for maintenance
and service or repair of the monitoring system. Refer to the institution for any
additional training or skill requirements beyond those identified here for maintenance and repair of the monitoring system. Before servicing, thoroughly read
this manual.
1-1
Introduction
1.3.1 Safety Symbols
1.3 Safety Information
Table1-1.Safety Symbol Definitions
Symbol Definition
WARNING
Warnings alert users to potential serious outcomes (death, injury, or adverse
events) to the patient, user, or environment.
Caution
Cautions alert users to exercise appropriate care for safe and effective use of
the product.
Note
Notes provide additional guidelines or information.
1.3.2 Warnings
WARNING:
Explosion hazard — Do not use in the presence of flammable anesthetics.
WARNING:
Shock hazard — Use only when connected to a grounded outlet to avoid
electric shock.
WARNING:
Before attempting to open or disassemble, disconnect the power cord to
avoid possible injury.
WARNING:
Use only Covidien-approved internal batteries.
WARNING:
The monitoring system is not defibrillator-proof. It may remain attached to
the patient during defibrillation or during use of an electrosurgical unit,
1-2 Service Manual
however, readings may be inaccurate during use in this environment and
shortly thereafter.
WARNING:
Supplemental oxygen will attenuate patterns of desaturation. A patient’s
respiratory compromise can be proportionally more severe before patterns
appear in the saturation trend. Remain vigilant when monitoring a patient on
supplemental oxygen.
WARNING:
Do not silence or disable audible alarms or decrease the volume of the audible
alarm if patient safety could be compromised. Do not dim or disable visual
alarms if patient safety could be compromised.
WARNING:
Ensure the monitoring system is clear of any obstructions that prevent
awareness of visual or audible alarms. Failure to do so may result in
inadvertently missing a visual alarm or an inaudible alarm tone.
Safety Information
WARNING:
Do not use any monitoring system, sensor, cable, or connector that appears
damaged. Remove any damaged equipment from service for inspection by a
qualified service technician.
WARNING:
Do not lift by the sensor or interface cable. The cable may disconnect,
potentially dropping the monitoring system on a patient or damaging
surface.
WARNING:
When installing the AC power cord, ensure the cord is carefully positioned to
prevent tripping and entanglement.
WARNING:
Do not spray, pour, or spill any liquid on the monitoring system, its accessories,
connectors, switches, or openings in the chassis, since this may cause damage
to the monitoring system.
Service Manual 1-3
Introduction
WARNING:
WARNING:
WARNING:
1.3.3 Cautions
To ensure accurate performance and prevent device failure, do not subject to
extreme moisture, such as direct exposure to rain. Such exposure may cause
inaccurate performance or device failure.
The monitoring screen contains toxic chemicals. Do not touch a broken
enclosure or monitoring screen. Physical contact with a broken enclosure or
monitoring screen can result in transmission or ingestion of toxic substances.
No user serviceable parts inside.
Caution:
Federal law (U.S.A.) restricts this device to sale by or on the order of a
physician.
Caution:
When connecting the monitoring system to any instrument, verify proper
operation before clinical use. Both the monitoring system and the instrument
connected to it must utilize a grounded outlet. Any equipment connected to
the data interface must be certified according to the latest IEC/EN 60950 -1
standard for data-processing equipment, the latest IECEN 60601-1 standard
for electromedical equipment, or the latest IEC/EN safety standards relevant
to that equipment. All combinations of equipment must be in compliance
with Requirements for Medical Electrical Systems IEC Standard
60601-1:2007and the electromagnetic compatibility IEC/EN Standard
60601-1:2005. Anyone who connects equipment to the data interface is
configuring a medical system and, therefore, is responsible for ensuring that
the system complies with the Requirements for Medical Electrical Systems
IEC/EN Standard 60601-1-1:2007 and the electromagnetic compatibility IEC/
EN Standard 60601-1-2:2007. Accuracy may degrade if it is connected to
secondary I/O devices when the equipment is not connected to earth
reference.
1-4 Service Manual
Caution:
Observe electrostatic discharge (ESD) precautions prior to opening the chassis
or handling any internal components.
Caution:
Observe the required torque for tightening screws. Over-tightening can strip
out screw holes, rendering them useless.
1.4 Obtaining Technical Assistance
1.4.1 Technical Services
For technical information and assistance, if unable to correct a problem while
using the monitoring system, to order parts, or to order an Operator’s or
Service Manual, contact Covidien or a local Covidien representative.
Obtaining Technical Assistance
Covidien Technical Services: Patient Monitoring
15 Hampshire Street
Mansfield, MA 02048 USA
1.800.635.5267, 1.925.463.4635 (toll)
or contact a local Covidien representative
www.covidien.com
When calling Covidien or a local Covidien representative, have the serial
number, as well as the code versions available.
To locate the serial number and code versions
1. Press MENU.
2. Press ABOUT THE MONITOR.
3. Locate the serial number under Monitor Information and code versions under
Software Information.
Service Manual 1-5
Introduction
1.4.2 On-Screen Help
The monitoring system provides users with an on-screen help system for
various help topics. Reference To access on-screen help topics, p. 6-16.
1.5 Related Documents
Documentation is available online at www.covidien.com. Covidien makes available all appropriate information relevant to servicing monitoring system parts
designated as repairable in this manual. For further assistance, contact Covidien.
• Nellcor™ Bedside Respiratory Patient Monitoring System Operator’s
Manual — Provides basic information on operating the monitoring system and
troubleshooting errors or malfunctions. Before using the monitoring system, thoroughly read this manual.
• Nellcor™ Sensor Instructions for Use — Guides sensor selection and usage.
Before attaching any of the various Covidien-approved Nellcor™ sensors to the
monitoring system, refer to their Instructions for Use.
• Nellcor™ Oxygen Saturation Accuracy Specification Grid — Provides
sensor-specific guidance related to desired SpO2 saturation accuracy measure-
ments.
1.6 Warranty Information
To obtain information, contact Covidien or a local Covidien representative.
Purchase of this instrument confers no express or implied license under any
Covidien patent to use that instrument with any sensor not manufactured or
licensed by Covidien llc.
1-6 Service Manual
2 Product Specifications
2.1 Overview
This chapter contains physical and operational specifications of the
Nellcor™ Bedside Respiratory Patient Monitoring System. Ensure all product
requirements are met prior to installation.
2.2 Physical Characteristics
Weight 7.5 lbs. (3.4 kg)
Dimensions 10 in. x 6.5 in. x 5 in. (252 mm x 163 mm x 122 mm)
2.3 Electrical Requirements
2.3.1 Power
Power Requirements Rated at 80-263 volts AC (nominal 120-230 VAC), 30 VA
Input Frequency 47/63 Hz
Fuses Slow-blow 1.5 amp, 250 volts, IEC (5 x 20 mm)
Quantity: 2 external
2-1
Product Specifications
2.3.2 Battery
Note:
The battery provides approximately seven hours of battery life when new and fully-charged
with no alarms, no serial data, no analog output, no nurse call output, with backlight on
while using a pulse simulator set for 200 bpm, high light and low modulation.
Type Lithium Ion
Voltage 7.2 Volts DC, 11.6 Ah, 83 Wh
Recharge 8 hours with monitoring system turned off
Shelf Life Four months, if monitoring system runs on new, fully-charged battery
12 hours with monitoring system turned on
After four months storage, units run 33% of stated battery life
Compliance IEC 62133
2.3.3 Rating of Nurse Call Relay
Maximum Input Voltage 30 VAC or VDC (polarity is not important)
Load Current 120 mA continuous (peak 300 mA @ 100 ms)
Minimum Resistance 26.5 ohms to 50.5 ohms (40.5 ohms typical) during alarms
Ground Reference Isolated Ground
Electrical Isolation 1500 Volts
2-2 Service Manual
2.4 Environmental Conditions
2.4.1 Operating
Temperature 5 ºC to 40 ºC (41 ºF to 104 ºF)
Altitude -304.8 m to 4,572 m
(-1,000 ft. to 15,000 ft.)
Atmospheric Pressure 105 kPa to 57.2 kPa
(31.0 in. Hg to 16.89 in. Hg)
Relative Humidity 15% to 95% non-condensing
2.4.2 Transport and Storage
Environmental Conditions
Not in shipping container In shipping container
Temperature -20 ºC to 60 ºC
(-4 ºF to 140 ºF)
Altitude -390 m to 5,574 m (-1,254 ft. to 18,288 ft.)
Atmospheric Pressure 50 kPa to 106 kPa (14.7 in. Hg to 31.3 in. Hg)
Relative Humidity 15% to 95% non-condensing
-20 ºC to 70 ºC
(-4 ºF to 158 ºF)
Service Manual 2-3
Product Specifications
2.5 Sensor Accuracy and Ranges
This monitoring system has the capability to detect physiological alarm conditions using SpO2 accuracy, pulse rate accuracy and alarm limit conditions.
Table2-1.Nellcor™ Sensor Accuracy and Ranges
Measurement Range
SpO
2
1% to 100%
Pulse Rate 20 to 250 beats per minute (bpm)
Perfusion Range 0.03% to 20%
Accuracy
1
Saturation
2, 3
Adult
Adult and Neonate Low Sat
Neonate
Low Perfusion
4, 5
6
2, 3, 4
Adult and Neonate with Motion
2, 7
70 to 100% ±2 digits
60 to 80% ±3 digits
70 to 100% ±2 digits
70 to 100% ±2 digits
70 to 100% ±3 digits
Pulse Rate
Adult and Neonate
Low Perfusion
Adult and Neonate with Motion
1. Saturation accuracy varies by sensor type. Refer to the Nellcor™ Oxygen Saturation Accuracy Specification Grid at
www.covidien.com/rms.
2. Accuracy specifications were validated using measurements of healthy non-smoking adult volunteers during controlled
hypoxia studies spanning the specified saturation ranges. Subjects were recruited from the local population and comprised
both men and women ranging in age from 18-50 years old, and spanned a range of skin pigmentations. Pulse oximeter
SpO2 readings were compared to SaO2 values of drawn blood samples measured by hemoximetry. All accuracies are
expressed as ±1 SD. Because pulse oximeter equipment measurements are statistically distributed, about two-thirds of the
measurements can be expected to fall in this accuracy (A
3. Adult specifications are shown for OXIMAX MAX-A and MAX-N sensors with the Nellcor™ Bedside Respiratory Patient Monitoring System.
4. Neonate specifications are shown for OXIMAX MAX-N sensors with the Nellcor™ Bedside Respiratory Patient Monitoring System.
5. Clinical functionality of the MAX-N sensor has been demonstrated on a population of hospitalized neonate patients. The
observed SpO2 accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4,100 grams,
and 63 observations made spanning a range of 85% to 99% SaO2.
6. Specification applies to Nellcor™ Bedside Respiratory Patient Monitoring System oximeter performance. Reading accuracy
in the presence of low perfusion (detected IR pulse modulation amplitude 0.03% - 1.5%) was validated using signals
supplied by a patient simulator. SpO2 and pulse rate values were varied across the monitoring range over a range of weak
signal conditions and compared to the known true saturation and pulse rate of the input signals.
7. Motion performance was validated during a controlled hypoxia blood study. Subjects performed rubbing and tapping
movements 1-2 cm in amplitude with aperiodic intervals (randomly changing) with a random variation in frequency between
1-4 Hz. Applicability: OXIMAX MAX-A, MAX-AL, MAX-P, MAX-I, and MAX-N sensors.
2, 3, 4
6
2, 7
) range (refer to the Sensor Accuracy Grid for more details).
RMS
20 to 250 bpm ±3 digits
20 to 250 bpm ±3 digits
48 to 127 bpm ±5 digits
2-4 Service Manual
Table2-2.Nellcor™ Sensor Operating Range and Power Dissipation
Red Light Wavelength Approximately 660 nm
Infrared Light Wavelength Approximately 900 nm
Optical Output Power Less than 15 mW
Power Dissipation 52.5 mW
2.6 Sound Pressure
Sound Pressure
Operating Range and Dissipation
Table2-3.Sound Pressure in Decibels
Volume Setting
Alarm Type
High Priority 88.1 dB 85.5 dB 80.6 dB 71.5 dB
Medium Priority 78.3 dB 75.4 dB 70.2 dB 61.2 dB
Low Priority 74.4 dB 71.1 dB 66.4 dB 57.6 dB
SPD Alarm (Low Priority) 74.4 dB 70.7 dB 65.7 dB 57.5 dB
2.7 Product Compliance
Equipment Classification IEC/EN 80601-2-61:2011
Protection Type Class I (Internally powered)
Degree of Protection Type BF - Applied part
Mode of Operation Continuous
Electromagnetic Compatibility IEC 60601-1-2:2007
High Med High Med Low Low
IEC/EN 60601-1:2005
CAN/CSA C22.2 No. 60601-1:08
ANSI AAMI ES 60601-1:2005
Liquid Ingress IPX1: Protected against harmful effects of dripping water
Degree of Safety Not suitable for use in the presence of flammable anesthetics
Service Manual 2-5
Product Specifications
2.8 Manufacturer’s Declaration and Guidance
2.8.1 Electromagnetic Compatibility (EMC)
WARNING:
This monitoring system is intended for use by healthcare professionals only.
This monitoring system may cause radio interference or may disrupt the
operation of nearby equipment, regardless of whether it is CISPR compliant
or not. It may be necessary to take mitigation measures, such as re-orienting
or relocating the monitoring system or shielding the location.
WARNING:
The use of accessories, sensors, and cables other than those specified may
result in inaccurate readings of the monitoring system and increased EMI
emissions of the monitoring system.
The monitoring system is suitable for prescription use only in the specified electromagnetic environments, in accordance with the IEC 60601-1-2:2007 standard. The
monitoring system requires special precautions during installation and operation
for electromagnetic compatibility. In particular, the use of nearby mobile or portable communications equipment may influence monitoring system performance.
Frequency and Bandwidth for Wireless Connection
Table2-4.Frequency Band, Output Power, and Modulation Type
Frequency Band
(MHz)
2412 - 2462 0.088 BPSK, CCK, OFDM
5180 - 5240 0.018 OFDM
5260 - 5320 0.018 OFDM
5500 - 5700 0.028 OFDM
5745 - 5825 0.026 OFDM
Output Power
(Watts)
Modulation Type
2-6 Service Manual
Manufacturer’s Declaration and Guidance
Electromagnetic Emissions
Table2-5.Electromagnetic Emissions Guidelines and Compliance
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
(IEC/EN 60601-1-2:2007, Table 1)
The monitoring system is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitoring system should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment Guidance
RF emission
CISPR 11
EN 55011
Harmonic emissions
IEC/EN 61000-3-2
Voltage fluctuation/
flicker emissions
IEC/EN 61000-3-3
Group 1,
Class A
Class A N/A
Complies N/A
Not intended for use in a residential environment. If
used in a domestic environment, may not offer adequate protection to radio-frequency communication
services. The user may be required to take mitigation
measures, such as relocating or re-orienting the equipment.
Service Manual 2-7
Product Specifications
Electromagnetic Immunity
The monitoring system is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitoring system should assure that it is used in such an environment.
Table2-6.Electromagnetic Immunity Guidelines and Compliance
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
(IEC/EN 60601-1-2:2007, Table 2)
Immunity
Test
Electrostatic
discharge (ESD)
IEC/EN 61000-4-2
Electric fast
transient/burst
IEC/EN 61000-4-4
Surge
IEC/EN 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
IEC/EN 61000-4-11
IEC/EN 60601-1-2
Test Level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV input/
output lines
± 1 kV differential
mode
± 2 kV common
mode
<5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
(60% dip in U
T
)
T
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
Compliance
Level
± 6 kV contact
± 8 kV air
± 2 kV for
power supply lines
± 1 kV input/
output lines
± 1 kV differential
mode
± 2 kV common
mode
<5% U
T
(>95% dip in UT)
for 0.5 cycle
40% U
(60% dip in U
T
)
T
for 5 cycles
70% U
T
(30% dip in UT)
for 25 cycles
Electromagnetic Environment
Guidance
Floor should be wood, concrete,
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Mains power quality should be
that of a typical commercial and/
or hospital environment.
Mains power quality should be
that of a typical commercial and/
or hospital environment.
Mains power quality should be
that of a typical commercial and/
or hospital environment.
If the user requires continued
operation during power mains
interruption, it is recommended
that the monitoring system be
powered from an uninterruptible
power supply or battery.
Power frequency
(50/60 Hz) magnetic
field
IEC/EN 61000-4-8
Note: U
is the AC main’s voltage prior to application of the test level.
T
<5% U
T
(>95% dip in UT)
for 5 seconds
3 A/m 3 A/m It may be necessary to position
<5% U
T
(>95% dip in UT)
for 5 seconds
further from the sources of
power frequency magnetic fields
or to install magnetic shielding.
2-8 Service Manual
Manufacturer’s Declaration and Guidance
d 1.2 P=
d 1.2 P=
d 2.3 P=
Table2-7.Recommended Separation Distance Calculations
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
(IEC/EN 60601-1-2:2007, Table 4)
The monitoring system is intended for use in the electromagnetic environment specified below. The
customer or the user of the monitoring system should assure that it is used in such an environment.
Immunity
Test
IEC/EN 60601-1-2
Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the monitoring
system, including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Conducted RF
IEC/EN
61000-4-6
Radiated RF
IEC/EN
61000-4-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2.5 GHz
Recommended Separation Distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in
meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey
compliance level in each frequency range
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should
be considered. If the measured field strength in the location in which the monitoring system is used exceeds the
applicable RF compliance level above, the monitoring system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
monitoring system.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
a
, should be less than the
b
.
Service Manual 2-9
Product Specifications
d 1.2 P=
d 1.2 P=
d 2.3 P=
Recommended Separation Distances Between Portable and Mobile RF Communications
The monitoring system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the monitoring system can help prevent elec-
tromagnetic interference by maintaining a minimum distance between portable and mobile RF com-
munications equipment (transmitters) and the monitoring system as recommended below, according
to the maximum output power of the communications equipment.
Table2-8.Recommended Separation Distances
Equipment and the Monitoring System
(IEC/EN 60601-1-2:2007, Table 6)
Rated Maximum
Output Power (P)
of Transmitter in
Watts
0.01 0.12 0.12 0.23
0.10 0.38 0.38 0.73
1.00 1.20 1.20 2.30
10.00 3.80 3.80 7.30
100.00 12.00 12.00 23.00
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Separation Distance According to Frequency of Transmitter in Meters
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
2-10 Service Manual
Sensor and Cable Compliance
WARNING:
The use of accessories, sensors, and cables other than those specified may
result in inaccurate readings of the monitoring system and increased emission
of the monitoring system.
Manufacturer’s Declaration and Guidance
Table2-9.Sensor and Cable Length
Item SKU Maximum Length
Sensors
Nellcor™ Adult SpO
Nellcor™ Adult XL SpO
Nellcor™ Forehead SpO
Nellcor™ Neonatal-Adult SpO
(Sterile, single-use only)
Nellcor™ Infant SpO
Nellcor™ Pediatric SpO
Nellcor™ Adult SpO
Nellcor™ Adult SpO
Nellcor™ Adult-Neonatal SpO
(Reusable with adhesive)
Nellcor™ Pediatric-Infant SpO
(Reusable with adhesive)
Nellcor™ Pediatric SpO
(Sterile, single-use only)
Nellcor™ Neonatal-Adult SpO
(Sterile, single-use only)
Nellcor™ Adult SpO
(Sterile, single-use only)
2 Sensor, Reusable (Nonsterile) DS100A 3.0 ft. (0.9 m)
2 Sensor (Sterile, single-use only) MAX-AL 3.0 ft. (0.9 m)
2 Sensor (Sterile, single-use only) MAX-FAST 2.5 ft (0.75 m)
2 Sensor (Sterile, single-use only) MAX-I
2 Sensor (Sterile, single-use only) MAX-P
2 Sensor (Sterile, single-use only) MAX-A
2 Nasal Sensor (Sterile, single-use only) MAX-R
2 Sensor, Two Piece
2 Sensor, Two Piece
2 Sensor
2 Sensor with Wraps
2 Sensor with Wraps
2 Sensor, Two Piece
MAX-N
OXI-A/N
OXI-P/I
P
N
A
1.5 ft. (0.5 m)
3.0 ft. (0.9 m)
OC-3 cable,
3.0 ft. (0.9 m)
Nellcor™ SpO
• Nellcor™ SpO2 Ear Clip, Reusable (Nonsterile) D-YSE
• Nellcor™ Pediatric SpO2 Clip, Reusable (Nonsterile) D-YSPD
Service Manual 2-11
2 Sensor, Multisite Reusable (Nonsterile) D-YS
4.0 ft. (1.2 m)
Product Specifications
Power cord ---- 9.84 ft. (3 m)
DOC-10 interface cable 10.0 ft. (3 m)
Firmware download cable, RS-232 serial, 15 to 9 pin “D” 10.0 ft. (3 m)
Non-terminated cable, RS-232 analog, 15 pin “D” 3.3 ft. (1 m)
Printer cable, RS-232, 15 to 9 pin “D” 10.0 ft. (3 m)
Philips interface cable M1943 NL 3.3 ft. (1 m)
Oxinet™ III hardwire cable ---- 10.0 ft. (3 m)
Oxinet™ III data cable
Table2-9.Sensor and Cable Length (Continued)
Item SKU Maximum Length
Cables
2.8.2 Ground Integrity
100 milliohms or less
2.8.3 Safety Tests
The following tables describe the maximum earth and enclosure leakage
current allowed, as well as patient leakage.
Table2-10.Earth and Enclosure Leakage Current Specifications
Earth Leakage Current
Neutral
Condition AC Line Polarity Line Cord
Normal Normal Closed Closed 500 μA 300 μA
Single Fault Open Closed 1000 μA
Closed Open
Normal Reversed Closed Closed 500 μA 300 μA
Single Fault Open Closed 1000 μA
Line Cord IEC 60601-1
ANSI/AAMI
60601-1
Closed Open
2-12 Service Manual
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