Covidien Nellcor PM10N User manual

Brand: Covidien

Model: Nellcor PM10N

Type: User manual

This manual is also suitable for

NellcorTM Portable SpO2 Patient Monitoring System

Service Manual

Nellcor

Portable SpO2 Patient Monitoring System

COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered

trademarks of Covidien AG. ™* brands are trademarks of their respective owner. Other brands are trademarks of a Covidien

company.

Service Manual i

Table of Contents

1 Introduction

1.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

1.2.1 Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.2.2 Explosion, Shock, and Toxicity Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

1.2.3 Service Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

1.2.4 Monitoring System Operation and Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

1.2.5 Patient Monitoring and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

1.2.6 Monitoring System Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.2.7 Sensors, Cables, and Other Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

1.2.8 Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6

1.2.9 Connections with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.2.10 Monitoring System Storage, Transport, and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

1.3 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

1.3.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-8

1.3.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

1.4 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

2 Service Menu Options

2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.2 Safety Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.3 Service Menu Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.3.1 Power On Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.3.2 Permission to Mute Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.3.3 Alarm Silence Duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

2.3.4 Power Saving Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

2.3.5 Battery Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

2.3.6 Date/Time Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

2.3.7 Communication Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

2.3.8 Alarm Priority Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

2.3.9 Languages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

2.3.10 Dynamic Password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

2.3.11 Enable PCSync Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

2.3.12 About Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

2.3.13 Covidien Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

3 Data Management

3.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.2 External Data Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.2.1 Monitoring History Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

ii Service Manual

3.3 Firmware Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

4 Modification and Testing

4.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2 Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.3 System Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.3.1 Power-On Self-Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.3.2 Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

4.3.3 Patient Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

4.3.4 Homecare Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

4.3.5 Sleep Study Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

4.3.6 Dynamic Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

4.3.7 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

4.4 Operational and Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

4.4.1 General Operation Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10

4.4.2 Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26

4.5 Verification Check Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45

5 Troubleshooting

5.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.2.1 Error Conditions by Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.2.2 System Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

5.3 Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8

6 Repair

6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.2 Spare Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

6.3 Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

6.4 Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

6.4.1 Remove the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

6.4.2 Replace the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5

6.5 Disassembly and Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

6.5.1 Front and Rear Assembly Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

6.5.2 NELL1SR Board Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

6.5.3 Main Board Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

6.5.4 Coin Cell Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-11

6.5.5 LCD Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-12

6.5.6 PI Cable and Cable Housing Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-13

Service Manual iii

List of Tables

Table1-1.Safety Symbol Definitions...............................................................................1-2

Table2-1.Service Menu Settings......................................................................................2-2

Table3-1.Monitoring Status Codes.................................................................................3-6

Table4-1.Required Test Equipment ...............................................................................4-2

Table4-2.Patient Modes .....................................................................................................4-5

Table4-3.Functional Tests with SRC-MAX................................................................. 4-27

Table5-1.Error Conditions and Resolutions ................................................................5-2

Table5-2.System Error Codes ...........................................................................................5-6

Table6-1.Spare Parts List by Callout Number.............................................................6-2

Table6-2.Monitoring System Accessories....................................................................6-4

Page Left Intentionally Blank

iv Service Manual

Service Manual v

List of Figures

Figure2-1. Service Menu ................................................................................................................. 2-3

Figure3-1. Mini-USB Port ................................................................................................................ 3-3

Figure3-2. Transfer Data Type ...................................................................................................... 3-4

Figure3-3. Transfer Data by USB .................................................................................................. 3-4

Figure3-4. Sample Monitoring History Printout .................................................................... 3-5

Figure3-5. Sample Bridge Driver Installer Window .............................................................. 3-7

Figure3-6. Sample New Hardware Wizard Screen ................................................................ 3-7

Figure3-7. Device Manager Button, Hardware Tab .............................................................. 3-8

Figure3-8. Sample Hardware List in Device Manager Window ........................................ 3-9

Figure3-9. Sample Initial USB to UART Bridge Properties Window .............................. 3-10

Figure3-10. Baud Rate List, Port Settings Tab ....................................................................... 3-11

Figure3-11. Firmware Upgrade Mode ..................................................................................... 3-12

Figure3-12. Firmware Upgrade, PCSync™* Utility ............................................................... 3-12

Figure3-13. Firmware Upgrade Process ................................................................................. 3-13

Figure3-14. POST Screen and Firmware Version ................................................................. 3-14

Figure4-1. Power-On Self-Test Sequence ................................................................................ 4-3

Figure4-2. Change Patient Mode Menu ................................................................................... 4-4

Figure4-3. Homecare Mode Menu Item ................................................................................... 4-5

Figure4-4. Homecare Mode Monitoring Screen .................................................................... 4-6

Figure4-5. Sleep Study Mode Menu Item ................................................................................ 4-7

Figure4-6. Service Menu ................................................................................................................. 4-8

Figure4-7. Dynamic Password Menu (Homecare to Standard Example) ...................... 4-8

Figure4-8. Password Set or Reset (Homecare to Standard Example) ............................ 4-9

Figure4-9. Date/Time Settings ..................................................................................................... 4-9

Figure4-10. Sensor Port ................................................................................................................ 4-10

Figure4-11. Sensor Port ................................................................................................................ 4-11

Figure4-12. Low SpO2 Alarm Limit of 99% ............................................................................ 4-12

Figure4-13. Low Pulse Alarm Limit of 160BPM .................................................................... 4-13

Figure4-14. Alarm Silence Duration Setting of 30 Seconds ............................................ 4-14

Figure4-15. Permission to Mute Alarm ................................................................................... 4-15

Figure4-16. Confirmation for Muted Alarm ........................................................................... 4-15

Figure4-17. Alarm Volume Default Setting of 2 ................................................................... 4-17

Figure4-18. Key Beep Volume Default Setting of 0 ............................................................ 4-18

Figure4-19. Pulse Volume Default Setting of 0 .................................................................... 4-19

Figure4-20. Brightness Setting .................................................................................................. 4-20

Figure4-21. “Spot Reading Saved” Message ......................................................................... 4-21

Figure4-22. Monitoring History Spot Data ............................................................................ 4-21

Figure4-23. Sensor Disconnect Alarm Priority Setting ...................................................... 4-22

Figure4-24. Sensor Off Alarm ..................................................................................................... 4-23

Figure4-25. Screen Saver Time Setting ................................................................................... 4-24

Figure4-26. Auto Power Off Time Setting .............................................................................. 4-26

Figure4-27. SRC-MAX Oximetry Tester ................................................................................... 4-28

Figure4-28. SRC-MAX Tester-Generated Waveform .......................................................... 4-29

vi Service Manual

Figure4-29. SRC-MAX Increase to 200 BPM .......................................................................... 4-30

Figure4-30. SRC-MAX Decrease to 60 BPM ........................................................................... 4-30

Figure4-31. SRC-MAX %SpO2 Increase to 90 ....................................................................... 4-31

Figure4-32. SRC-MAX %SpO2 Decrease to 75 ..................................................................... 4-32

Figure4-33. SRC-MAX High Modulation ................................................................................. 4-33

Figure4-34. BPM of 200 with High Modulation ................................................................... 4-34

Figure4-35. BPM of 60 with High Modulation ...................................................................... 4-35

Figure4-36. %SpO2 of 90 with High Modulation ................................................................ 4-36

Figure4-37. %SpO2 of 75 with High Modulation ................................................................ 4-37

Figure4-38. %SpO2 of 75 with Low Modulation ................................................................. 4-38

Figure4-39. High Light Condition ............................................................................................. 4-39

Figure4-40. BPM of 200 with High Light Condition ........................................................... 4-40

Figure4-41. BPM of 60 with High Light Condition .............................................................. 4-41

Figure4-42. %SpO2 of 90 with High Light Condition ........................................................ 4-42

Figure4-43. %SpO2 of 75 with High Light Condition ........................................................ 4-43

Figure4-44. High Modulation and High Light Condition ................................................. 4-44

Figure5-1. Return Packaging ......................................................................................................... 5-9

Figure6-1. Exploded View ............................................................................................................... 6-2

Figure6-2. Standard Cover (3 Shown) and Ambulatory Cover ......................................... 6-4

Figure6-3. Battery Replacement .................................................................................................. 6-5

Figure6-4. Front and Rear Assembly Replacement ............................................................... 6-7

Figure6-5. NELL1SR Board Replacement .................................................................................. 6-9

Figure6-6. Main Board Replacement ....................................................................................... 6-10

Figure6-7. Coin Cell Battery Replacement ............................................................................. 6-11

Figure6-8. LCD Replacement ..................................................................................................... 6-12

Figure6-9. PI Cable and Cable Housing Replacement ...................................................... 6-13

1-1

1 Introduction

1.1 Overview

This manual contains information for servicing the Nellcor™ portable SpO2 patient monitoring

system.

This manual applies to the following product:

Note:

Before use, carefully read this manual, the Operator’s Manual, accessory Instructions for Use, and all

precautionary information and specifications.

Reference the Operator’s Manual for the following information:

•Intended Use statement

•Operations-related warnings and cautions

•Overviews of the display and operating buttons

•Descriptions of product and packaging symbols

•Installation and operation instructions

•Alarms management

•Preventive maintenance

•Performance considerations

•Accessories

•Theory of operations

•Product specifications

•Clinical studies

PM10N

Introduction

1-2 Service Manual

1.2 Safety Information

This section contains important safety information related to general use of the Nellcor™ portable

SpO2 patient monitoring system. Other important safety information appears throughout the

manual. The Nellcor™ portable SpO2 patient monitoring system is referred to as the “monitoring

system” throughout this manual.

1.2.1 Safety Symbols

1.2.2 Explosion, Shock, and Toxicity Hazards

WARNING:

Explosion hazard — Do not use the monitoring system in the presence of flammable anesthetics.

WARNING:

Shock hazard—Do not pour or spill liquids onto the monitoring system.

WARNING:

Shock hazard—Firmly close the battery cover to prevent moisture from entering the monitoring

system.

WARNING:

The LCD panel (display) contains toxic chemicals. Do not touch broken LCD panels. Physical

contact with a broken LCD panel can result in transmission or ingestion of toxic substances.

Table1-1.Safety Symbol Definitions

Symbol Definition

WARNING

Alerts users to potential serious outcomes (death, injury, or adverse events) to the

patient, user, or environment.

Caution

Identifies conditions or practices that could result in damage to the equipment or

other property.

Note

Provides additional guidelines or information.

Safety Information

Service Manual 1-3

1.2.3 Service Procedures

WARNING:

To avoid possible injury, do not attempt to service the monitoring system if there are any signs of

burning or smoking coming from the monitoring system.

WARNING:

Before attempting to service the monitoring system, disconnect it from the patient to avoid

possible injury to the patient.

WARNING:

Before attempting to disassemble the monitoring system, remove the batteries to prevent

possible injury.

WARNING:

Ensure that conductive portions of the electrodes, leads, and cable do not come into contact with

any other conductive parts.

WARNING:

High voltage is generated by the LCD backlight driver. Exercise caution when operating the

monitoring system with covers open.

WARNING:

Extreme care must be taken in modifying default or other settings to ensure they are appropriate

to the intended use.

WARNING:

Make sure to complete all performance tests in Chapter 4, Modification and Testing before placing

the monitoring system into operation after repair or maintenance. Failure to perform all tests

could result in erroneous monitoring system readings.

WARNING:

Any connections between this monitoring system and other devices must comply with applicable

medical systems safety standards such as IEC 60601-1. Failure to do so could result in unsafe

leakage current and grounding conditions.

WARNING:

To ensure accurate performance and prevent device failure, do not expose the monitoring system

to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate

performance or device failure. Reference the Operator’s Manual for fluid ingress specifications.

Introduction

1-4 Service Manual

1.2.4 Monitoring System Operation and Service

WARNING:

Inspect the monitoring system and all accessories before use to ensure there are no signs of

physical damage or improper function. Do not use if damaged.

WARNING:

To ensure accurate performance and prevent device failure, do not expose the monitoring system

to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate

performance or device failure. Do not immerse in water, solvents, or cleaning solutions, since the

monitoring system and pulse oximetry sensors and connectors are not waterproof.

WARNING:

Do not sterilize the monitoring system by irradiation, steam, or ethylene oxide.

WARNING:

The monitoring system should not be used adjacent to or stacked with other equipment. If

adjacent or stacked use is necessary, observe the monitoring system to verify normal operation in

the desired configuration.

WARNING:

The only user-serviceable parts inside the monitoring system are the four AA batteries. While users

can open the battery cover to change the batteries, only qualified service personnel should

remove the cover or access internal components for any other reason. Users should not modify

any components of the monitoring system.

WARNING:

Do not spray, pour, or spill any liquid on the monitoring system, its accessories, connectors,

switches, or openings in the casing, since this may cause damage to the monitoring system. Never

place fluids on the monitoring system. If fluid spills on the monitoring system, remove batteries,

wipe all components dry immediately, and have the monitoring system serviced to ensure no

hazard exists.

WARNING:

Do not damage the batteries by applying pressure. Do not throw, hit, drop, or impact the batteries.

WARNING:

Keep the monitoring system and batteries out of the reach of children.

Caution:

The monitoring system may not operate properly if it is operated or stored at conditions outside

the ranges stated in this manual, or if it is subjected to excessive shock or dropping.

Safety Information

Service Manual 1-5

1.2.5 Patient Monitoring and Safety

WARNING:

Always disconnect and remove the monitoring system and sensors during magnetic resonance

imaging (MRI) scanning. Attempting to use the monitoring system during an MRI procedure could

cause burns or adversely affect the MRI image or the monitoring system's accuracy.

WARNING:

Keep patients under close surveillance when monitoring. It is possible, although unlikely, that

radiated electromagnetic signals from sources external to the patient and the monitoring system

can cause inaccurate measurement readings.

WARNING:

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient

entanglement or strangulation.

WARNING:

Do not lift or carry the monitoring system by the pulse oximetry sensor or pulse oximetry interface

cable. The cable may disconnect and cause the monitoring system to drop on a patient or cause

damage to monitoring system surfaces.

1.2.6 Monitoring System Readings

WARNING:

The monitoring system may remain attached to the patient during defibrillation or during use of

an electrosurgical unit; however, the monitoring system is not defibrillator-proof, and readings

may be inaccurate during defibrillation and shortly thereafter.

WARNING:

Check the patient's vital signs by alternate means should there be any doubt about the accuracy

of any measurement. Request a qualified service technician confirm the monitoring system is

functioning correctly.

WARNING:

For best product performance and measurement accuracy, use only accessories supplied or

recommended by Covidien. Use accessories according to their respective Instructions for Use.

Introduction

1-6 Service Manual

1.2.7 Sensors, Cables, and Other Accessories

WARNING:

Before use, carefully read the pulse oximetry sensor Instructions for Use, including all warnings,

cautions, and instructions.

WARNING:

Use only the Covidien-approved pulse oximetry sensors, interface cables, and accessories. Use of

other sensors, cables, and accessories can result in inaccurate readings and increased monitoring

system emissions.

WARNING:

Do not use any other cables to extend the length of the Covidien-approved interface cable.

Increasing the length will degrade signal quality and may lead to inaccurate measurements.

WARNING:

To prevent damage, avoid undue bending of the sensor cable.

WARNING:

The sensor disconnect error message and associated alarm indicate the pulse oximetry sensor is

either disconnected or has faulty wiring. Check the connection and, if necessary, replace the

sensor, the pulse oximetry cable, or both.

1.2.8 Electromagnetic Interference

WARNING:

Any radio frequency transmitting equipment or other nearby sources of electrical noise may result

in disruption of the monitoring system.

WARNING:

The monitoring system is designed for use in environments in which the signal can be obscured by

electromagnetic interference. During such interference, measurements may seem inappropriate

or the monitoring system may not seem to operate correctly.

WARNING:

Large equipment using a switching relay for its power on/off may affect monitoring system

operation. Do not operate the monitoring system in such environments.

Safety Information

Service Manual 1-7

Caution:

This device has been tested and found to comply with the limits for medical devices related to IEC

60601-1-2: 2007 and IEC 60601-1-2:2014. These limits are designed to provide reasonable

protection against harmful interference in a typical medical installation.

Caution:

This monitoring system generates, uses, and can radiate radio frequency energy and, if not

installed and used in accordance with the instructions, may cause harmful interference to other

devices in the vicinity. If interference is suspected, move pulse oximetry cables away from the

susceptible device.

Caution:

Be aware of possible interference from sources of electromagnetic interference, such as cellular

phones, radio transmitters, motors, telephones, lamps, electrosurgical units, defibrillators, and

other medical devices. If pulse oximetry readings are not as expected for the patient’s condition,

remove the sources of possible interference.

1.2.9 Connections with Other Equipment

Caution:

Accessory equipment connected to the monitoring system's data interface must be certified

according to IEC 60950-1 for data-processing equipment. All combinations of equipment must be

in compliance with IEC 60601-1 Requirements for Medical Electrical Systems. Anyone who

connects additional equipment to the signal input or signal output port configures a medical

system and is therefore responsible for ensuring the system complies with the requirements of IEC

60601-1, IEC 60601-1-2:2007, and IEC 60601-1-2:2014.

Caution:

When connecting the monitoring system to any instrument, verify proper operation before clinical

use.

Caution:

Anyone who connects a PC to the data output port configures a medical system and is therefore

responsible for ensuring that the system complies with the requirements of IEC 60601-1-1 and the

electromagnetic compatibility IEC 60601-1-2.

1.2.10 Monitoring System Storage, Transport, and Disposal

Caution:

Remove the batteries from the monitoring system before placing it in storage or when not using

it for a long period.

Introduction

1-8 Service Manual

Caution:

Do not short-circuit the batteries, as they may generate heat. To avoid short-circuiting, do not let

the batteries come in contact with metal objects at any time, especially during transport.

Caution:

Follow local government ordinances and recycling instructions regarding disposal or recycling of

the monitoring system and its components, including batteries and accessories.

1.3 Obtaining Technical Assistance

1.3.1 Technical Services

For technical information and assistance, contact Covidien or a local Covidien representative.

When calling Covidien or a local Covidien representative, have the monitoring system serial

number available. The serial number label is located on the bottom of the monitoring system.

Provide the firmware version number displayed during the power-on self-test (POST).

1.3.2 Related Documents

Nellcor™ Portable SpO2 Patient Monitoring System Operator’s Manual —

Provides basic information

for operating the monitoring system and troubleshooting errors or malfunctions.

Nellcor™ Pulse Oximetry Sensor Instructions for Use — Guides sensor selection and usage. Before

attaching any of the various Covidien-approved pulse oximetry sensors to the monitoring system,

refer to the individual Instructions for Use.

Nellcor™ Oxygen Saturation Accuracy Specification Grid — Provides sensor-specific guidance related

to desired SpO2 saturation accuracy measurements. Available online with the product manuals for the

monitoring system at www.covidien.com.

Covidien Technical Services: Patient Monitoring

15 Hampshire Street

Mansfield, MA 02048 USA

1.800.635.5267, 1.925.463.4635,

or contact a local Covidien representative

www.covidien.com

Warranty Information

Service Manual 1-9

1.4 Warranty Information

The information contained in this document is subject to change without notice. Covidien makes

no warranty of any kind with regard to this material, including, but not limited to, the implied

warranties of merchantability and fitness for a particular purpose. Covidien 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.

Introduction

Page Left Intentionally Blank

1-10 Service Manual

2-1

2 Service Menu Options

2.1 Overview

This chapter describes Service Menu settings for the Nellcor™ portable SpO2 patient monitoring

system. A password is required to access the Service Menu. Contact Technical Services

(reference Technical Services, page 1-8) for the default password.

2.2 Safety Reminders

WARNING:

For best product performance and measurement accuracy, use only accessories supplied or

recommended by Covidien. Use accessories according to their respective Instructions for Use.

WARNING:

The sensor disconnect error message and associated alarm indicate the pulse oximetry sensor is

either disconnected or has faulty wiring. Check the connection and, if necessary, replace the

sensor, the pulse oximetry cable, or both.

WARNING:

Do not use damaged pulse oximetry sensors. Do not use with exposed optical components. Do

not immerse completely in water, solvents, or cleaning solutions, since pulse oximetry sensors

and connectors are not waterproof. Do not sterilize by irradiation, steam or ethylene oxide. Refer

to the cleaning instructions in the Instructions for Use for reusable sensors.

Caution:

Do not attach any cable intended for computer use to the sensor port connector.

2.3 Service Menu Overview

WARNING:

Only qualified service personnel should open the monitoring system housing, remove and

replace parts, or make adjustments.

Service Menu Options

2-2 Service Manual

The monitoring system contains a Service Menu that is accessible only by password. Contact

Technical Services (reference Technical Services, page 1-8) for the default passwords for all

restricted menus and functions.

The monitoring system ships with the Service Menu factory default settings listed in Table 2-1. For

a list of the factory default settings for other menus, reference the Operator’s Manual.

Table2-1.Service Menu Settings

Parameter Ranges/selection

Factory default

Adult Pediatric Neonatal

Power On Settings Factory Defaults, Institutional Defaults, Last Setting Factory Defaults

Permission to Mute Alarm No, Yes No

Alarm Silence Duration 30, 60, 90, 120 seconds 120 seconds

Power Saving Settings Screen Saver Time:

Never, 1 - 10 minutes

3 minutes

Screen Saver Brightness:

0% - 50% in 10% increments

20%

Auto Power Off Time:

Never, 1 - 10 minutes

3 minutes

Battery Type Lithium, Alkaline Lithium

Date/Time Settings Date Format:

YY/MM/DD, DD/MM/YY, MM/DD/YY

YY/MM/DD

Communication Settings Serial Connectivity Settings:

ASCII 19200, ASCII 115200,

SPDout 19200, SPDout 115200

ASCII, 19200

Alarm Priority Settings Low, Medium, High:

- Sensor Disconnect

- Sensor Off

- Sensor Failure

Low

Low, Medium, High:

- SpO2 High

- Pulse Rate High

Medium

Medium, High:

- SpO2 Low

- Pulse Rate Low

Medium

Languages Chinese, Czech, Danish, Dutch, English, Finnish,

French, German, Greek, Hungarian, Italian,

Japanese, Korean, Norwegian, Polish, Portuguese,

Russian, Slovakian, Spanish, Swedish, Turkish

English

Dynamic Password Passwords can be changed for entry into Homecare

Mode and Sleep Study Mode and back to Standard

Mode

(Contact Technical Services)

Enable PCSync Mode On, Off Off

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Model: Nellcor PM10N

Type: User manual

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