PM10N Portable SpO2 System Service Manual Rev B Feb 2015

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 1.2

Overview... 1-1 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 2.2

2.3

Overview... 2-1 External Data Communication... 2-1 Real-Time Data Transmission... 2-2 Monitoring History Download... 2-7 Firmware Upgrade... 2-18

3

Modification and Testing

3.1 3.2 3.3

Overview... 3-1 Required Equipment... 3-2 System Performance Tests... 3-2 Power-On Self-Test (POST)... 3-2 Battery Status... 3-3 Patient Modes... 3-4 Homecare Mode... 3-5 Sleep Study Mode... 3-7 Dynamic Passwords ... 3-8 Date and Time... 3-10 Wireless Network Connectivity... 3-11 Operational and Functional Tests... 3-15 General Operation Tests... 3-15

2.2.1 2.2.2

3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.4 3.4.1

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3.4.2 3.5 3.5.1

4

Troubleshooting

4.1 4.2

4.3

Overview... 4-1 Troubleshooting Guide... 4-1 Error Conditions by Category ... 4-2 System Error Codes... 4-6 Return ... 4-9

5

Repair

5.1 5.2 5.3 5.4

Overview... 5-1 Spare Parts and Accessories... 5-2 Required Tools... 5-4 Battery Replacement... 5-5 Remove the Batteries... 5-5 Replace the Batteries... 5-6 Disassembly and Reassembly... 5-6 Front and Rear Assembly Replacement... 5-7 NELL1SR Board Replacement... 5-9 Main Board Replacement ... 5-11 Coin Cell Battery Replacement ... 5-12 Wireless Board Replacement... 5-13 LCD Replacement... 5-15 PI Cable and Cable Housing Replacement... 5-16

4.2.1 4.2.2

5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.5.6 5.5.7

iv

Functional Tests... 3-33 Verification Check Sheets... 3-53 Performance, Operation, and Functional Test Results... 3-53

List of Figures Figure 2-1. Figure 2-2. Figure 2-3. Figure 2-4. Figure 2-5. Figure 2-6. Figure 2-7. Figure 2-8. Figure 2-9. Figure 2-10. Figure 2-11. Figure 2-12. Figure 2-13. Figure 2-14. Figure 2-15. Figure 2-16. Figure 2-17. Figure 2-18. Figure 2-19. Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 3-8. Figure 3-9. Figure 3-10. Figure 3-11. Figure 3-12. Figure 3-13. Figure 3-14. Figure 3-15. Figure 3-16. Figure 3-17. Figure 3-18. Figure 3-19. Figure 3-20. Figure 3-21. Figure 3-22. Figure 3-23. Figure 3-24. Figure 3-25.

Communication Settings-Oxinet ... 2-3 Remote Connectivity Selections ... 2-4 New Connection Settings ... 2-5 Wi-Fi On/Off Setting ... 2-6 Wi-Fi On/Off Setting ... 2-7 Mini-USB Port ... 2-9 Transfer Data Type ... 2-10 Transfer Data by USB ... 2-10 Sample Monitoring History Printout ... 2-11 Bridge Driver Installer Window ... 2-13 New Hardware Wizard Screen ... 2-14 Device Manager Button, Hardware Tab ... 2-15 Hardware List in Device Manager Window ... 2-16 Sample Initial USB to UART Bridge Properties Window ... 2-17 Baud Rate List, Port Settings Tab ... 2-18 Firmware Upgrade Mode ... 2-19 Firmware Upgrade, PCSync Utility ... 2-20 Firmware Upgrade Process ... 2-21 POST Screen and Firmware Version ... 2-21 Power-On Self-Test Sequence ... 3-3 Change Patient Mode Menu ... 3-4 Homecare Mode Menu Item ... 3-6 Homecare Mode Monitoring Screen ... 3-7 Sleep Study Mode Menu Item ... 3-8 Service Menu ... 3-9 Dynamic Password Menu (Homecare to Standard Example) ... 3-9 Password Set or Reset (Homecare to Standard Example) ... 3-10 Date/Time Settings ... 3-11 Communications Settings ... 3-12 Add New Connection Menu ... 3-13 Device Settings Menu ... 3-14 Sensor Port ... 3-15 Sensor Port ... 3-17 Low SpO2 Alarm Limit of 99% ... 3-17 Low Pulse Alarm Limit of 160BPM ... 3-18 Alarm Audio Paused Setting of 30 Seconds ... 3-19 Permission to Mute Alarm ... 3-20 Confirmation for Muted Alarm ... 3-21 Alarm Volume Default Setting of 2 ... 3-22 Key Beep Volume Default Setting of 0 ... 3-23 Pulse Volume Default Setting of 0 ... 3-24 Brightness Setting ... 3-25 “Spot Reading Saved” Message ... 3-26 Monitoring History Spot Data ... 3-27

v

Figure 3-26. Figure 3-27. Figure 3-28. Figure 3-29. Figure 3-30. Figure 3-31. Figure 3-32. Figure 3-33. Figure 3-34. Figure 3-35. Figure 3-36. Figure 3-37. Figure 3-38. Figure 3-39. Figure 3-40. Figure 3-41. Figure 3-42. Figure 3-43. Figure 3-44. Figure 3-45. Figure 3-46. Figure 3-47. Figure 4-1. Figure 5-1. Figure 5-2. Figure 5-3. Figure 5-4. Figure 5-5. Figure 5-6. Figure 5-7. Figure 5-8. Figure 5-9. Figure 5-10.

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Sensor Disconnect Alarm Priority Setting ... 3-28 Sensor Off Alarm ... 3-29 Screen Saver Time Setting ... 3-30 Auto Power Off Time Setting ... 3-32 SRC-MAX OxiMax Oximetry Tester ... 3-35 SRC-MAX Tester-Generated Waveform ... 3-36 SRC-MAX Increase to 200 BPM ... 3-37 SRC-MAX Decrease to 60 BPM ... 3-38 SRC-MAX %SpO2 Increase to 90 ... 3-39 SRC-MAX %SpO2 Decrease to 75 ... 3-40 SRC-MAX High Modulation ... 3-41 BPM of 200 with High Modulation ... 3-42 BPM of 60 with High Modulation ... 3-43 %SpO2 of 90 with High Modulation ... 3-44 %SpO2 of 75 with High Modulation ... 3-45 %SpO2 of 75 with Low Modulation ... 3-46 High Light Condition ... 3-47 BPM of 200 with High Light Condition ... 3-48 BPM of 60 with High Light Condition ... 3-49 %SpO2 of 90 with High Light Condition ... 3-50 %SpO2 of 75 with High Light Condition ... 3-51 High Modulation and High Light Condition ... 3-52 Return Packaging ... 4-10 Exploded View ... 5-2 Standard Cover (3 Shown) and Ambulatory Cover ... 5-4 Battery Replacement ... 5-5 Front and Rear Assembly Replacement ... 5-8 NELL1SR Board Replacement ... 5-10 Main Board Replacement ... 5-11 Coin Cell Battery Replacement ... 5-13 Wireless Board Replacement ... 5-14 LCD Replacement ... 5-15 PI Cable and Cable Housing Replacement ... 5-17

List of Tables Table 1-1. Table 2-1. Table 3-1. Table 3-2. Table 3-3. Table 3-4. Table 4-1. Table 4-2. Table 5-1. Table 5-2.

Safety Symbol Definitions... 1-2 Monitoring Status Codes ... 2-12 Required Test Equipment ... 3-2 Patient Modes ... 3-5 Wireless Status Icon... 3-14 Functional Tests with SRC-MAX ... 3-33 Error Conditions and Resolutions... 4-2 System Error Codes... 4-6 Spare Parts List by Callout Number... 5-3 Monitoring System Accessories ... 5-4

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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: PM10N PM10N-W



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 instructions

•

Alarms management

•

Preventive maintenance

•

Performance considerations

•

Accessories

•

Theory of operations

•

Clinical studies

1-1

Introduction

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

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

  

1-2

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.

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Safety Information



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

      

Service Manual

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 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.

1-3

Introduction

 

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.

1.2.4 Monitoring System Operation and Service

    

1-4

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,

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Safety Information

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. 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

 

Service Manual

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.

1-5

Introduction

 

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.

1.2.7 Sensors, Cables, and Other Accessories



1-6

WARNING: Before use, carefully read the pulse oximetry sensor Instructions for Use, including all warnings, cautions, and instructions.

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Safety Information

   

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

  

Service Manual

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.

1-7

Introduction

  

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. 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

  

1-8

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

Service Manual

Safety Information

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

  

Service Manual

Caution: Remove the batteries from the monitoring system before placing it in storage or when not using it for a long period. 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. Caution: Follow local government ordinances and recycling instructions regarding disposal or recycling of the monitoring system and its components, including batteries and accessories.

1-9

Introduction

1.3

Obtaining Technical Assistance

1.3.1 Technical Services

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 - 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 Directions for Use. Saturation Accuracy Grid - Provides sensor-specific guidance related to desired SpO2 saturation accuracy measurements. Available online at www.covidien.com.

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Revision History

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.

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