Nellcor Portable SpO2 Service manual

Service Manual

Nellcor

TM

Portable SpO2 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.

©2014 Covidien. All rights reserved.

Microsoft and Windows CE 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 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

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

1.2.8 Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

1.2.9 Connections with Other Equipment . . . . . . . . . . . . . . . . . . . . . . . 1-8

1.2.10 Monitoring System Storage, Transport, and Disposal . . . . . . . . . . 1-9

1.3 Obtaining Technical Assistance . . . . . . . . . . . . . . . . . . . . . . . . 1-10

1.3.1 Technical Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

1.3.2 Related Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

1.4 Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

1.5 Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

2 Data Management

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

2.2 External Data Communication . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.2.1 Real-Time Data Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

2.2.2 Monitoring History Download . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

2.3 Firmware Upgrade . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

3 Modification and Testing

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

3.2 Required Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

3.3 System Performance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

3.3.1 Power-On Self-Test (POST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

3.3.2 Battery Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.3.3 Patient Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

3.3.4 Homecare Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

3.3.5 Sleep Study Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

3.3.6 Dynamic Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

3.3.7 Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.3.8 Wireless Network Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . 3-11

3.4 Operational and Functional Tests . . . . . . . . . . . . . . . . . . . . . . 3-15

3.4.1 General Operation Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

iii

3.4.2 Functional Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33

3.5 Verification Check Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-53

3.5.1 Performance, Operation, and Functional Test Results . . . . . . . . . 3-53

4 Troubleshooting

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

4.2 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.2.1 Error Conditions by Category . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.2.2 System Error Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

4.3 Return . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

5 Repair

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

5.2 Spare Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.3 Required Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

5.4 Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

5.4.1 Remove the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

5.4.2 Replace the Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

5.5 Disassembly and Reassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6

5.5.1 Front and Rear Assembly Replacement . . . . . . . . . . . . . . . . . . . . 5-7

5.5.2 NELL1SR Board Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

5.5.3 Main Board Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

5.5.4 Coin Cell Battery Replacement . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

5.5.5 Wireless Board Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

5.5.6 LCD Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

5.5.7 PI Cable and Cable Housing Replacement . . . . . . . . . . . . . . . . . 5-16

iv

List of Figures

Figure2-1. Communication Settings—Oxinet ............................................. 2-3

Figure2-2. Remote Connectivity Selections ................................................. 2-4

Figure2-3. New Connection Settings .......................................................... 2-5

Figure2-4. Wi-Fi On/Off Setting ................................................................. 2-6

Figure2-5. Wi-Fi On/Off Setting ................................................................. 2-7

Figure2-6. Mini-USB Port ........................................................................... 2-9

Figure2-7. Transfer Data Type .................................................................. 2-10

Figure2-8. Transfer Data by USB .............................................................. 2-10

Figure2-9. Sample Monitoring History Printout ........................................ 2-11

Figure2-10. Bridge Driver Installer Window ................................................ 2-13

Figure2-11. New Hardware Wizard Screen ................................................. 2-14

Figure2-12. Device Manager Button, Hardware Tab ................................... 2-15

Figure2-13. Hardware List in Device Manager Window .............................. 2-16

Figure2-14. Sample Initial USB to UART Bridge Properties Window ............ 2-17

Figure2-15. Baud Rate List, Port Settings Tab ............................................. 2-18

Figure2-16. Firmware Upgrade Mode ........................................................ 2-19

Figure2-17. Firmware Upgrade, PCSync Utility ........................................... 2-20

Figure2-18. Firmware Upgrade Process ...................................................... 2-21

Figure2-19. POST Screen and Firmware Version ......................................... 2-21

Figure3-1. Power-On Self-Test Sequence ................................................... 3-3

Figure3-2. Change Patient Mode Menu ..................................................... 3-4

Figure3-3. Homecare Mode Menu Item ..................................................... 3-6

Figure3-4. Homecare Mode Monitoring Screen .......................................... 3-7

Figure3-5. Sleep Study Mode Menu Item ................................................... 3-8

Figure3-6. Service Menu ............................................................................ 3-9

Figure3-7. Dynamic Password Menu (Homecare to Standard Example) ....... 3-9

Figure3-8. Password Set or Reset (Homecare to Standard Example) .......... 3-10

Figure3-9. Date/Time Settings .................................................................. 3-11

Figure3-10. Communications Settings ....................................................... 3-12

Figure3-11. Add New Connection Menu ................................................... 3-13

Figure3-12. Device Settings Menu ............................................................. 3-14

Figure3-13. Sensor Port ............................................................................. 3-15

Figure3-14. Sensor Port ............................................................................. 3-17

Figure3-15. Low SpO

Figure3-16. Low Pulse Alarm Limit of 160BPM ........................................... 3-18

Figure3-17. Alarm Audio Paused Setting of 30 Seconds ............................. 3-19

Figure3-18. Permission to Mute Alarm ....................................................... 3-20

Figure3-19. Confirmation for Muted Alarm ............................................... 3-21

Figure3-20. Alarm Volume Default Setting of 2 ......................................... 3-22

Figure3-21. Key Beep Volume Default Setting of 0 .................................... 3-23

Figure3-22. Pulse Volume Default Setting of 0 ........................................... 3-24

Figure3-23. Brightness Setting ................................................................... 3-25

Figure3-24. “Spot Reading Saved” Message .............................................. 3-26

Figure3-25. Monitoring History Spot Data .................................................. 3-27

2 Alarm Limit of 99% ................................................ 3-17

v

Figure3-26. Sensor Disconnect Alarm Priority Setting ................................. 3-28

Figure3-27. Sensor Off Alarm .................................................................... 3-29

Figure3-28. Screen Saver Time Setting ....................................................... 3-30

Figure3-29. Auto Power Off Time Setting .................................................. 3-32

Figure3-30. SRC-MAX OxiMax Oximetry Tester .......................................... 3-35

Figure3-31. SRC-MAX Tester-Generated Waveform ................................... 3-36

Figure3-32. SRC-MAX Increase to 200 BPM ............................................... 3-37

Figure3-33. SRC-MAX Decrease to 60 BPM ............................................... 3-38

Figure3-34. SRC-MAX %SpO
Figure3-35. SRC-MAX %SpO

2 Increase to 90 ............................................ 3-39

2 Decrease to 75 ........................................... 3-40

Figure3-36. SRC-MAX High Modulation .................................................... 3-41

Figure3-37. BPM of 200 with High Modulation .......................................... 3-42

Figure3-38. BPM of 60 with High Modulation ............................................ 3-43

Figure3-39. %SpO
Figure3-40. %SpO
Figure3-41. %SpO

2 of 90 with High Modulation ....................................... 3-44

2 of 75 with High Modulation ....................................... 3-45

2 of 75 with Low Modulation ........................................ 3-46

Figure3-42. High Light Condition ............................................................... 3-47

Figure3-43. BPM of 200 with High Light Condition .................................... 3-48

Figure3-44. BPM of 60 with High Light Condition ...................................... 3-49

Figure3-45. %SpO
Figure3-46. %SpO

2 of 90 with High Light Condition ................................. 3-50

2 of 75 with High Light Condition ................................. 3-51

Figure3-47. High Modulation and High Light Condition ............................. 3-52

Figure4-1. Return Packaging .................................................................... 4-10

Figure5-1. Exploded View .......................................................................... 5-2

Figure5-2. Standard Cover (3 Shown) and Ambulatory Cover .................... 5-4

Figure5-3. Battery Replacement ................................................................. 5-5

Figure5-4. Front and Rear Assembly Replacement ...................................... 5-8

Figure5-5. NELL1SR Board Replacement ................................................... 5-10

Figure5-6. Main Board Replacement ........................................................ 5-11

Figure5-7. Coin Cell Battery Replacement ................................................ 5-13

Figure5-8. Wireless Board Replacement ................................................... 5-14

Figure5-9. LCD Replacement ................................................................... 5-15

Figure5-10. PI Cable and Cable Housing Replacement ............................... 5-17

vi

List of Tables

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

Table2-1. Monitoring Status Codes ........................................................ 2-12

Table3-1. Required Test Equipment ......................................................... 3-2

Table3-2. Patient Modes ........................................................................... 3-5

Table3-3. Wireless Status Icon................................................................. 3-14

Table3-4. Functional Tests with SRC-MAX ............................................. 3-33

Table4-1. Error Conditions and Resolutions............................................. 4-2

Table4-2. System Error Codes.................................................................... 4-6

Table5-1. Spare Parts List by Callout Number .......................................... 5-3

Table5-2. Monitoring System Accessories ................................................ 5-4

vii

Page Left Intentionally Blank

viii

1 Introduction

1.1 Overview

This manual contains information for servicing the Nellcor™ Portable SpO2
Patient Monitoring System.

This manual applies to the following products:

 Note:

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

PM10N

PM10N-W

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 instructions

• Alarms management

• Preventive maintenance

• Performance considerations

• Accessories

• Theory of operations

• Clinical studies

1-1

Introduction

1.2.1 Safety Symbols

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.

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.

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.

1-2 Service Manual

 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.

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.

Safety Information

 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 and safety tests outlined in Chapter

3, 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.

Service Manual 1-3

Introduction

 WARNING:

 WARNING:

1.2.4 Monitoring System Operation and Service

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.

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.

 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
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.

by irradiation, steam, or ethylene

 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,

1-4 Service Manual

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, or drop
or impact the batteries.

Safety Information

 WARNING:

Keep the monitoring system and batteries out of reach of children to avoid
any accidents.

 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.

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.

Service Manual 1-5

Introduction

 WARNING:

 WARNING:

1.2.6 Monitoring System Readings

 WARNING:

As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.

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.

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.

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.

1-6 Service Manual

 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

 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.

Safety Information

emissions.

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.

Service Manual 1-7

Introduction

 Caution:

 Caution:

 Caution:

This device has been tested and found to comply with the limits for medical
devices related to IEC 60601-1-2: 2007. These limits are designed to provide
reasonable protection against harmful interference in a typical medical
installation.

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.

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 60601-1:2005
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 60601-1:2005 and IEC 60601-1-2:2007.

 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

1-8 Service Manual

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
or when not using it for a long period.

before placing it in storage

 Caution:

Do not short-circuit the batteries, as they may generate heat. To avoid short­circuiting, do not let the batteries come in contact with metal objects at any
time, especially during transport.

Safety Information

 Caution:

Follow local government ordinances and recycling instructions regarding
disposal or recycling of the monitoring system

batteries and accessories.

and its components, including

Service Manual 1-9

Introduction

1.3.1 Technical Services

1.3 Obtaining Technical Assistance

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

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

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 —

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 Directions for Use.

Saturation Accuracy Grid — Provides sensor-specific guidance related to desired

2 saturation accuracy measurements. Available online at www.covidien.com.

SpO

Provides basic information for operating the monitoring

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1.4 Revision History

The documentation part number and revision number indicate its current edi­tion. The revision number changes when Covidien prints a new edition. Minor
corrections and updates incorporated at reprint do not cause a change in the
revision number. Extensive changes may require a new document part number.

1.5 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.

Revision History

Service Manual 1-11

Introduction

Page Left Intentionally Blank

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2 Data Management

2.1 Overview

This chapter contains information for accessing, transmitting, and download­ing patient monitoring data and history. This chapter also contains instructions
for upgrading firmware for the Nellcor™ Portable SpO2 Patient Monitoring
System. The monitoring system supports the following types of data viewing
and transmission:

• Transmit real-time data — Real-time patient data transmission by Wi-Fi to the

Oxinet III Remote Patient Monitoring System or the Vital Sync Virtual Patient Mon­itoring System. Reference the Operator’s Manual.

• Access stored monitoring history — Monitoring history (trend data) can be

viewed anytime it is stored in the monitoring system. Reference the Operator’s
Manual.

• Download stored monitoring history — Monitoring history can be down-

loaded to a PC using HyperTerminal or other data transmission and analysis tools.

• Upgrade the monitoring system’s firmware — Occasionally, Covidien will

provide upgrades to the firmware for the monitoring system, which must be
loaded via the mini-USB port.

 Note:

The Wi-Fi feature is an option and does not exist on all Portable SpO
Monitoring Systems.

2.2 External Data Communication

 WARNING:

Any connections between this monitoring system and other devices must
comply with applicable medical systems safety standards such as IEC 60601-1
and applicable collaterals. Failure to do so may result in unsafe leakage
current and grounding conditions.

2 Patient

2-1

Data Management

 Caution:

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

 Caution:

Connect the monitoring system to a medical grade PC that is on an isolated
AC circuit.

 Note:

Reference the manuals for the Covidien Nellcor™ Oxinet III Remote Monitoring
System and Vital Sync™ System 2.0 or above for operation information and
recommendations for the placement of the monitoring system relative to the
distributed alarm system.

The monitoring system supports the following types of data communication:

• Real-time data transmission — Real-time data transmission by Wi-Fi to the

Covidien Nellcor™ Oxinet III Remote Monitoring System or the Vital Sync™
System 2.0 (or above) Virtual Patient Monitoring System.

• Monitoring history (trend data) download — Monitoring history downloads

by mini-USB connection to a PC using data transmission and analysis tools.

 Note:

To use the Wi-Fi feature (if available), a qualified service technician must first configure
the monitoring system to connect to a wireless network, as described in the following
sections.

2.2.1 Real-Time Data Transmission

Transfer real-time monitoring data to Covidien Nellcor™ Oxinet III or Vital
Sync™ System
the monitoring system to one of these applications.

To set up a new connection for Oxinet or VitalSync

1. Start Oxinet III or VitalSync 2.0 or above.

2.0 or above. First, set up a new connection, and then connect

2. Turn on the monitoring system and go to the Service Menu (pass code required).

3. In the Service Menu, select Communication Settings.

2-2 Service Manual

Figure2-1.Communication Settings—Oxinet

External Data Communication

4. Select Oxinet Settings and make the following settings:

• Destination IP Address — Set the IP address of the computer with the Oxinet or

VitalSync program installed

• Port — 18000 for Oxinet; 10001 for VitalSync

5. Select the data packet type (ASCII, SPDout) by selecting Remote Connectivity.

Service Manual 2-3

Data Management

Figure2-2.Remote Connectivity Selections

6. Select Add New Connection and set as follows:

a. SSID: Enter the SSID name of the AP (access point).

b. Encryption: Select the encryption type of the current AP.

c. Encryption Type: Set the password for each encryption type.

d. DHCP: Turn DHCP On or Off. (When On, the IP Address, Subnet Mask, and

Gateway setting are automatically assigned using DHCP.)

e. IP Address: If DHCP is Off, set the IP address of the monitoring system.

f. Subnet Mask: If DHCP is Off, set the subnet mask of the monitoring system.

g. Gateway: If DHCP is Off, set the gateway of the monitoring system.

h. After setting the new connection, select Save Connection to add the settings

to the Wi-Fi Target.

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Figure2-3.New Connection Settings

External Data Communication

7. From the Select Wi-Fi Target menu, select the AP saved in the previous step.

8. Exit the Service Menu and go to the Device Settings Menu.

To transfer real-time data to Oxinet

1. On the Device Settings menu, select Wi-Fi to activate the Wi-Fi connection.

Service Manual 2-5

Data Management

Figure2-4.Wi-Fi On/Off Setting

2. On the Oxinet interface, click the Administration button at the bottom of the

screen and verify that the BEDs are connected. (When a connection is first estab­lished, a BED is displayed in an orange color.)

3. Select the connected BED and select the room number.

4. After verifying that the room is selected, register the patient information.

5. Click the Monitor button on the middle of the Oxinet screen and verify that the

selected room is displayed on the screen.

6. To confirm the settings of the monitoring system, select the measurement value

on the Oxinet screen. Then verify the following items:

a. The high and low limit values of the %SpO2 and pulse rate.

b. Patient type (Adult or Neonate).

c. Protocol: ASCII.

d. SatSeconds settings.

e. Model: NPSPMS (Nellcor™ Portable SpO2 Patient Monitoring System). To

check the model name, select the Addition Information window at the bottom
right of the Oxinet screen.

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External Data Communication

To transfer real-time data to Vital Sync 2.0 or above

1. Reference To set up a new connection for Oxinet or VitalSync, p. 2-2 to connect

to a wireless network.

2. On the Device Settings menu, select Wi-Fi to activate the Wi-Fi connection.

Figure2-5.Wi-Fi On/Off Setting

3. The real-time data displays on the Vital Sync screen.

2.2.2 Monitoring History Download

The monitoring system presents monitoring history (trend data) in tabular
format. The newest data values appear at the top.

 WARNING:

Replacing the coin cell battery for the main board resets the monitoring
system’s date and time settings. Integrity of existing patient data will be
questionable. Reset the date and time after replacing this battery with a
known good battery.

 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

Service Manual 2-7

Data Management

with the requirements of IEC 60601-1-1 and the electromagnetic compatibility
IEC 60601-1-2.

 Caution:

Signal artifacts, secondary to a variety of external factors, may compromise
the presence or accuracy of the displayed values.

 Caution:

If the monitoring system does not contain its own isolation barrier, connect it
to a medical grade PC that is on an isolated AC circuit.

To download monitoring history (trend data), connect by mini-USB port to a
PC using HyperTerminal or other data transmission and analysis tools. Any PC
connected to the data port must be certified according to IEC 60950. All com­binations of equipment must be in compliance with IEC 60601-1-1 system
requirements.

 Note:

Users may choose to import patient monitoring history to a spreadsheet program. To
do so, export monitoring history using the ASCII format option. Have a qualified
service technician set this option prior to attempting a data download.

System Compatibility Prerequisites

• Windows-based PC

• HyperTerminal or equivalent software installed on PC

Hardware

• Mini-USB data download cable

• CD or thumb drive, if USB driver required

Data transfer by USB port relies on existing communication software drivers for
USB-based devices already on the computer, so should not require any modi­fication of the drivers used by the USB interface. If, for some reason, the com­puter does not have the correct USB driver, use the device driver provided on
the product CD or from Technical Services. Reference COM port USB Driver

Alternatives, p. 2-13.

2-8 Service Manual

 Note:

Any monitoring history download relies on either factory default settings or
institutional default settings established by a qualified service technician prior to
usage. This includes baud rate and communication protocol selection.

To download monitoring history using HyperTerminal

1. Configure the monitoring system’s Serial Connectivity Settings appropriately.

2. Connect the monitoring system’s mini-USB port to the computer.

External Data Communication

Figure2-6.Mini-USB Port

3. Execute HyperTerminal.

 Note:

If this is the first time the HyperTerminal program launches, it will prompt the user
to set it as the default Telnet program. Depending on institutional requirements,
choose Yes or No.

4. Set the appropriate values for HyperTerminal’s port settings:

a. Set the baud rate (bits per second) to match the monitoring system’s baud

rate.

b. Ensure the data bit is set to 8.

c. Ensure the parity bit is set to none.

d. Ensure the stop bit is set to 1.

e. Ensure the flow control is set to off.

5. From the monitoring system’s Transfer Data menu, select Spot Data or Continu-

ous Data.

Service Manual 2-9

Data Management

Figure2-7.Transfer Data Type

6. Select By USB.

Figure2-8.Transfer Data by USB

The data is transferred, and a progress bar is displayed. If desired, select Cancel to
abort the transmission.

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