Bedside SpO2 Patient Monitoring System Service Manual Rev A March 2019

Table of Contents 1

Introduction

1.1 1.2 1.2.1 1.2.2 1.2.3 1.3 1.3.1 1.3.2 1.4 2

Overview... 1-1 Safety Information... 1-1 Safety Symbols... 1-2 Warnings... 1-2 Cautions... 1-4 Obtaining Technical Assistance... 1-5 Technical Services... 1-5 Related Documents... 1-6 Warranty Information... 1-6 Service Menu Options

2.1 2.2 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 2.3.8 2.3.9 2.3.10 2.3.11 2.3.12 2.3.13 3

Overview... 2-1 Safety Reminders... 2-1 Service Menu Overview... 2-2 Power On Settings... 2-3 Alarm Silence Duration... 2-3 Alarm Disabled Reminder... 2-4 Permission to Deactivate Audible Alarm... 2-4 Language... 2-4 Date/Time Setting... 2-4 System Information... 2-4 System Test... 2-4 Trend Data Download Settings... 2-5 Homecare Mode Settings... 2-5 Communication Settings... 2-5 Alarm Priorities... 2-5 Password Settings... 2-5 Data Management

3.1 3.2 3.3 3.3.1 3.4 4 4.1 4.2

Service Manual

Overview... 3-1 Trend Data... 3-1 External Data Communication... 3-2 Nurse Call Interface... 3-2 Firmware Upgrade... 3-5 Modification and Testing Overview... 4-1 Required Equipment... 4-2

i

4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.4 4.4.1 4.4.2 4.4.3 4.5 4.5.1 4.5.2 5

Troubleshooting

5.1 5.2 5.2.1 5.2.2 5.2.3 5.3 6

Overview... 5-1 Troubleshooting Guide... 5-1 Error Conditions by Category... 5-2 Firmware Download Errors... 5-6 Technical Alarm Conditions... 5-7 Return... 5-9 Repair

6.1 6.2 6.3 6.4 6.4.1 6.4.2 6.5 6.5.1 6.5.2 6.5.3 6.5.4 6.5.5 6.5.6 6.5.7 6.5.8 6.5.9 6.5.10

ii

System Performance Tests... 4-2 Power-On Self-Test (POST)... 4-2 Power... 4-3 Battery Charge... 4-3 Battery Discharge... 4-4 Patient Modes... 4-4 Date and Time... 4-6 Operational and Functional Tests... 4-7 General Operation Tests... 4-7 Functional Tests...4-14 Testing Nurse Call...4-25 Safety Tests... 4-27 Safety Testing Standards...4-27 Electrical Leakage...4-28

Overview... 6-1 Ordering Spare Parts... 6-2 Required Tools... 6-5 Battery Replacement... 6-5 Removing the Battery... 6-5 Replacing the Battery... 6-6 Disassembly and Reassembly... 6-7 Top Case Replacement... 6-8 Front Case Replacement...6-10 Multi-Functional Respiratory Board Replacement...6-12 Main Board Replacement...6-13 Coin Cell Battery Replacement...6-15 LCD Replacement...6-16 Control Buttons and Gasket Replacement...6-17 Power Supply Board Replacement...6-19 AC Inlet Replacement...6-20 Charger Board Replacement...6-21

Service Manual

Table of Contents 6.5.11 6.5.12 6.6 A

Service Manual

Nurse Call Board Replacement...6-23 Alarm Speaker Replacement...6-25 Optional Equipment... 6-26 Verification Check Sheets

iii

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iv

List of Tables Table 1-1. Table 2-1. Table 3-1. Table 3-2. Table 4-1. Table 4-2. Table 4-3. Table 4-4. Table 4-5. Table 4-6. Table 4-7. Table 4-8. Table 4-9. Table 5-1. Table 5-2. Table 5-3. Table 6-1.

Service Manual

Safety Symbol Definitions... 1-2 Service Menu Settings... 2-2 Nurse Call Relay Pins States for NORMALLY +... 3-3 Nurse Call Relay Pins States for NORMALLY –... 3-4 Required Test Equipment... 4-2 Patient Modes... 4-5 Patient Operating Modes... 4-6 Functional Tests with SRC-MAX... 4-14 Nurse Call Output Resistance (Normally +)... 4-26 Nurse Call Output Resistance (Normally –)... 4-27 Touch Current Values... 4-28 Patient Leakage Current Values... 4-29 Patient Leakage Current Values-Applied Part... 4-30 Error Conditions and Resolutions... 5-2 Firmware Download Error Codes... 5-6 Technical Error Codes... 5-7 Spare Parts List by Callout Number... 6-3

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vi

List of Figures Figure 2-1. Figure 2-2. Figure 2-3. 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 4-1. Figure 4-2. Figure 4-3. Figure 4-4. Figure 4-5. Figure 4-6. Figure 4-7. Figure 4-8. Figure 4-9. Figure 4-10. Figure 4-11. Figure 4-12. Figure 4-13. Figure 4-14. Figure 4-15. Figure 4-16. Figure 4-17. Figure 4-18. Figure 4-19. Figure 4-20. Figure 4-21. Figure 4-22. Figure 4-23. Figure 4-24. Figure 4-25. Figure 4-26. Figure 4-27. Figure 4-28. Figure 4-29. Figure 4-30. Figure 4-31.

Service Manual

Service Menu... 2-3 Password Settings Submenu (Example)... 2-6 Password Reset Example... 2-6 Nurse Call Interface Pin Layout... 3-3 SERVICE MENU - Communication Settings... 3-4 Communication Settings - Nurse Call Settings... 3-5 Nurse Call Settings Options... 3-5 Firmware Update Mode... 3-6 USB Port for Firmware Upgrade... 3-7 Firmware Upgrade Read, Erase, Write Messages... 3-7 Firmware Upgrade Restart Message... 3-8 POST Screen and Firmware Version Example... 3-8 Power-on Self-test Sequence (Example)... 4-3 Patient Mode Menu... 4-5 Date/Time Settings... 4-6 Sensor Port... 4-7 Sensor Port... 4-8 %SpO2 Lower Alarm Limit of 99... 4-9 Pulse Rate Lower Alarm Limit of 160... 4-9 Alarm Silence Duration Setting of 30 Seconds... 4-10 Alarm Disabled Reminder Setting of 3 Minutes... 4-11 Alarm Volume Default Setting of 5... 4-12 Key Beep Volume Default Setting of 4... 4-13 Pulse Volume Default Setting of 4... 4-13 SRC-MAX OxiMax™ Oximetry Tester... 4-15 SRC-MAX Tester-Generated Waveform... 4-16 SRC-MAX Increase to 200 BPM... 4-16 SRC-MAX Decrease to 60 BPM... 4-17 SRC-MAX %SpO2 Increase to 90... 4-17 SRC-MAX %SpO2 Decrease to 75... 4-18 SRC-MAX High Modulation... 4-19 200 BPM with High Modulation... 4-19 60 BPM with High Modulation... 4-20 %SpO2 of 90 with High Modulation... 4-20 %SpO2 of 75 with High Modulation... 4-21 %SpO2 of 75 with Low Modulation... 4-21 High Light Condition... 4-22 200 BPM with High Light Condition... 4-23 60 BPM with High Light Condition... 4-23 %SpO2 of 90 with High Light Condition... 4-24 %SpO2 of 75 with High Light Condition... 4-24 High Modulation and High Light Condition... 4-25 Nurse Call Connector... 4-26

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Figure 5-1. Figure 6-1. Figure 6-2. Figure 6-3. Figure 6-4. Figure 6-5. Figure 6-6. Figure 6-7. Figure 6-8. Figure 6-9. Figure 6-10. Figure 6-11. Figure 6-12. Figure 6-13. Figure 6-14. Figure 6-15.

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Return Packaging... 5-10 Disassembly Sequence... 6-2 Exploded View... 6-3 Battery Replacement... 6-6 Top Case Replacement... 6-9 Front Case Replacement... 6-11 Multi-Functional Respiratory Board Replacement... 6-12 Main Board Replacement... 6-14 Coin Cell Battery Replacement... 6-15 LCD Replacement... 6-16 Control Buttons and Gasket Replacement... 6-18 Power Supply Board Replacement... 6-19 AC Inlet Replacement... 6-21 Charger Board Replacement... 6-22 Nurse Call Board Replacement... 6-24 Alarm Speaker Replacement... 6-25

Service Manual

1 Introduction

1.1

Overview This manual contains information for servicing the Nellcor™ bedside SpO2 patient monitoring system. This manual applies to the following product: PM100N

 1.2

Note: This manual is meant to be used with the Operator’s Manual, which contains an overview of the product and packaging, installation, operation, performance considerations, preventive maintenance, accessories, theory of operations, product specifications, and clinical studies.

Safety Information This section contains important safety information related to general use of the Nellcor™ bedside SpO2 patient monitoring system. Other important safety information appears throughout the manual. The Nellcor™ bedside SpO2 patient monitoring system will be referred to as the “monitoring system” throughout this manual.

1-1

Introduction

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 Warnings

      1-2

WARNING: Explosion hazard - Do not use the monitoring system in the presence of flammable anesthetics. WARNING: Explosion hazard - Do not use the monitoring system with other manufacturers’ batteries. Do not use different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or Lithium-ion batteries together. WARNING: To prevent possible electric shock or explosion, do not service the monitoring system in a flammable environment or in an excessively moist environment. 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 open or disassemble the monitoring system, disconnect the power cord from the monitoring system to avoid possible injury.

Service Manual

Safety Information

        

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: During the safety test, AC power voltage will be present on the applied part terminals. Exercise caution to avoid electrical shock hazard. WARNING: Extreme care must be taken in modifying default or other settings to ensure they are appropriate to the intended use. WARNING: The LCD panel 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. WARNING: Make sure to complete all performance and safety tests outlined 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. WARNING: The use of accessories, sensors, and cables other than those specified may result in inaccurate readings of the monitoring system and increased EMI emissions and decreased electromagnetic immunity of the monitoring system.

Service Manual

1-3

Introduction

1.2.3 Cautions

        1-4

Caution: Observe ESD (electrostatic discharge) precautions when working within the unit and/or when disassembling and reassembling the monitoring system and when handling any components. 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. Caution: Do not spray, pour, or spill any liquid on the monitoring system, its accessories, connectors, switches, or openings in the chassis, since this may cause damage to the monitoring system. Never place fluids on the monitoring system. If fluid spills on the monitoring system, remove batteries, wipe dry immediately, and have it serviced to ensure no hazard exists. Caution: Do not immerse the monitoring system or its accessories in liquid or clean with caustic or abrasive cleaners. 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. Both the monitoring system and the instrument connected to it must be connected to a grounded outlet. Caution: For best product performance and measurement accuracy, use only accessories supplied or recommended by Covidien. Use accessories according to the manufacturer's instructions for use and institutional standards. Use only accessories that have passed the recommended biocompatibility testing in compliance with ISO10993-1. Caution: If the integrity of the AC power source is in doubt, ensure the monitoring system’s internal battery is fully charged.

Service Manual

Obtaining Technical Assistance

    1.3

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 with other devices in the vicinity. Caution: 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. Caution: When reassembling the monitoring system, over-tightening screws could strip the screw holes in the cases, rendering them unusable. Caution: Ferrite cores are used for electromagnetic compatibility. Do not remove ferrite cores while disassembling or reassembling; otherwise the monitoring system can be affected by electromagnetic interference and cause inaccurate data to be displayed or stored.

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).

Service Manual

1-5

Introduction

1.3.2 Related Documents

Nellcor™ bedside SpO2 patient monitoring system operator’s manual - Provides information about the product and packaging, installation, operation, performance considerations, preventive maintenance, accessories, theory of operations, product specifications, and clinical studies. When servicing the product, refer to the Operator’s Manual as necessary. Nellcor™ bedside SpO2 patient monitoring system home use guide - For caregivers in the home environment. Provides basic information for setup, operation, and cleaning of the monitoring system. 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. Saturation accuracy grid - Provides sensor-specific guidance related to desired SpO2 saturation accuracy measurements. Available online at www.covidien.com. 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.

1-6

Service Manual

2 Service Menu Options

2.1

Overview This chapter describes Service menu settings for the Nellcor™ bedside SpO2 patient monitoring system. A password is required to access the Service menu. Contact Technical Services (reference “Technical Services” on page 1-5) 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: 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. Caution: 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 it, the pulse oximetry cable, or both.

2-1

Service Menu Options

2.3



Service Menu Overview WARNING: Only qualified service personnel should open the monitoring system housing, remove and replace parts, or make adjustments.

The monitoring system contains menus that a clinician can access (Options, Alarm/Limits, and Patient Type), and a Service menu that is accessible only by password. Contact Technical Services (reference “Technical Services” on page 1-5) 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 the other menus, reference the Operator’s Manual. To access the Service menu, use the default password. Change a password by going to the Password Settings submenu in the Service menu. Table 2-1. Service Menu Settings Factory default Parameter

Ranges/selection Adult

Power On Settings

Factory Defaults, Last Settings, Institutional Defaults

Alarm Silence Duration

30, 60, 90, 120 s

60 s

Alarm Disabled Reminder

Off, 3, 10 min

3 min

Permission to deactivate audible alarm

Yes, No

Language

Chinese, Czech, Danish, Dutch, English, Finnish, French, German, Greek, Hungarian, Italian, Japanese, Korean, Norwegian, Polish, Portuguese, Russian, Slovakian, Spanish, Swedish, Turkish

Neonatal

Factory Defaults

No

English

Date/Time Setting

yy/mm/dd, mm/dd/yy, dd/mm/yy

yy/mm/dd

Homecare Mode Settings

Minimum Allowed Alarm Volume

1

Communication Settings

Serial Connectivity Settings: ASCII 19200, ASCII 115200, SPDout 19200, SPDout 115200

ASCII, 19200

Nurse Call Settings: Normally +, Normally –

Normally +

Sensor Disconnect Alarm, Sensor Off, Sensor Failure, SpO2 High, Pulse Rate High

High, Medium, or Low

Alarm Priorities

SpO2 Low, Pulse Rate Low Password Settings

2-2

Pediatric

Passwords can be changed for entry into Homecare mode and Sleep Study mode and back to Standard mode

High or Medium

(Contact Technical Services)

Service Manual

Service Menu Overview

Figure 2-1. Service Menu

2.3.1 Power On Settings



Note: Once changes are made to any settings, you must choose Last Settings or Institutional Defaults to have those settings saved when the monitoring system is powered off. Factory Defaults - The settings for the monitoring system when shipped from the manufacturer. Choose this option to reset all values to factory defaults. Institutional Defaults - The settings of the monitoring system for an individual institution or patient situation. Set all desired parameters, then go to the Service menu and select Institutional Defaults. The monitoring system powers off once you exit the Service menu. When you power on the monitoring system again, the institutional defaults you set will be active. When you switch between operating modes (for example, between Sleep Study mode and Standard mode), the institutional defaults are retained. Last Settings - The settings of the monitoring system are saved just before power off.



Caution: Last Settings should only be used in a service situation, not during normal operation.

2.3.2 Alarm Silence Duration

The amount of time the audible alarm remains silent after the Silence Alarm button is pressed. Options include 30, 60, 90, and 120 seconds.

Service Manual

2-3

Service Menu Options

2.3.3 Alarm Disabled Reminder

The amount of time after an alarm occurs before the user is alerted that the audible alarm is disabled, if the Permission to Deactivate Audible Alarm setting is Yes. Options include Off, 3 minutes, or 10 minutes. If the Permission to Deactivate Audible Alarm setting is No, the user is not allowed to deactivate the audible alarm. 2.3.4 Permission to Deactivate Audible Alarm

No - User cannot disable the audible alarm for SpO2 or pulse rate alarms. Yes - User can disable the audible alarm for SpO2 or pulse rate alarms.



Note: The visual alarm (the yellow background behind the SpO2 or pulse rate reading) is always enabled, even when the audible alarm is disabled.

2.3.5 Language

Displays most menu items in the chosen language (see Table 2-1 on page 2-2 for the complete list of languages). For some languages, certain menu items are not translated and always display in English. 2.3.6 Date/Time Setting

Provides options for the date format (yy/mm/dd, mm/dd/yy, or dd/mm/yy). Allows manual setting of the year, month, and day, and the hour, minute, and second for the current time zone. 2.3.7 System Information

Monitor On Time - The number of hours the monitoring system has been powered on. System Software Version - The version of the software (firmware) loaded on the monitoring system. SpO2 - The software version of the SpO2 circuit board installed in the monitoring system. 2.3.8 System Test

Switch/LED Test - Turn the knob and press the Silence Alarm button and the Home button. The corresponding area in the graphic on the screen lights up. LCD Test - Colors fill the entire screen in this order: red, blue, green, yellow. This pattern repeats until you press the knob. Alarm Audible Test - An audible alarm sounds until you press the knob.

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Service Manual

Service Menu Overview

Tone Audible Test - A single tone sounds. Buzzer Test - A buzzer sounds until you press the knob. 2.3.9 Trend Data Download Settings

The file output format to be used when trend data is transferred from the monitoring system to a PC. Protocol ASCII 1 - Nellcor™ ASCII protocol for use with Covidien-supplied software. Protocol ASCII 2 - ASCII format compatible with many spreadsheet programs. 2.3.10 Homecare Mode Settings

Minimum Allowed Volume indicates the volume setting for alarms, including a setting of 0 (mute). The institution or clinician should determine this setting for a lay user in the homecare environment. 2.3.11 Communication Settings

The serial connectivity settings to be used when trend data is transferred from the monitoring system to a PC using a USB cable. Options include: •

ASCII, 19200 baud

•

ASCII, 115200 baud

•

SPDout, 19200 baud

•

SPDout, 115200 baud

The settings to be used to configure the nurse call polarity. Options include: •

Normally +

•

Normally –

2.3.12 Alarm Priorities

Allows the setting of alarm priorities for Sensor Disconnect, Sensor Off, Sensor Failure, SpO2, and Pulse Rate alarms. Reference Table 2-1 on page 2-2. 2.3.13 Password Settings

Allows changes to the following passwords: •

Service Manual

Homecare mode to Standard mode

2-5