Bedside SpO2 Patient Monitoring System PM100N Service Manual Rev B Aug 2012

Table of Contents 1

Introduction

1.1 1.2

1.4 1.5

Overview... 11 Safety Information... 11 Safety Symbols... 11 Warnings Regarding Electric Shock and Explosion Hazards ... 12 Warnings Regarding Service Procedures ... 12 Patient-Related Warnings... 14 Cautions... 16 Obtaining Technical Assistance... 18 Technical Services... 18 Related Documents... 18 Revision History... 19 Warranty Information... 19

2

Product Specifications

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

Overview... 21 Physical Characteristics... 21 Electrical... 22 Environmental Conditions... 22 Tone Definition... 23 Performance Specifications ... 24 Sound Pressure... 25 Product Compliance ... 26 Manufacturer’s Declaration... 26 Electromagnetic Compatibility (EMC)... 26 Sensor and Cable Compliance... 30 Safety Tests... 30

1.2.1 1.2.2 1.2.3 1.2.4 1.2.5 1.3 1.3.1 1.3.2

2.9.1 2.9.2 2.9.3

3

Theory of Operations

3.1 3.2 3.3 3.4 3.5

Overview... 33 Theoretical Principles... 33 Automatic Calibration... 34 Functional Testers and Patient Simulators... 34 Unique Technologies... 35 Functional versus Fractional Saturation... 35 Measured versus Calculated Saturation... 36 ... 36 Data Update Period, Data Averaging, and Signal Processing... 36 SatSeconds™ Alarm Management Feature... 37 First SpO2 Event... 38

3.5.1 3.5.2 3.5.3 3.5.4 3.6 3.6.1

3

3.6.2 3.6.3 3.6.4

4

Product Overview

4.1 4.2 4.3 4.4

Overview... 43 Product Description... 43 Indications for Use ... 43 Product Views... 44 Front Panel and Display Components ... 44 Rear Panel... 48

4.4.1 4.4.2

5

Installation

5.1 5.2 5.3

Overview... 49 Safety Reminders ... 49 Unpacking and Inspection... 50 List of Components... 50 Setup... 51 Internal Battery Installation... 51 Connecting to Power ... 52 Using the Internal Battery... 53 Connecting a Nellcor™ Pulse Oximetry Sensor ... 55

5.3.1 5.4 5.4.1 5.4.2 5.4.3 5.4.4

6

Operation

6.1 6.2 6.3

Overview... 57 Safety Reminders ... 57 User Interface ... 58 Turning on the Monitoring System... 58 Turning off the Monitoring System... 59 Menu Options Navigation... 60 Menu Structure... 60 QUICK ACCESS Menus... 61 OPTIONS Menu... 63 Service Menu ... 66 ALARM LIMITS Menu ... 72 PATIENT MODE Menu... 74 SpO2 WAVEFORM Menu... 75 Managing Alarms and Alarm Limits ... 76 Audible Alarm Indicators... 77 Visual Alarm Indicators... 79

6.3.1 6.3.2 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.5 6.5.1 6.5.2

4

Second SpO2 Event... 39 Third SpO2 Event... 40 The SatSeconds Safety Net... 41

6.6

Factory Defaults

7

Data Management

7.1 7.2

7.4

Overview... 83 Trend Data... 84 Tabular Trend Data... 85 Graphical Trend Data ... 86 External Data Communication... 87 Nurse Call Interface... 87 Trend Data Download... 89 Firmware Upgrade ... 101

8

Performance Considerations

8.1 8.2

8.4

Overview... 105 Oximetry Considerations... 105 Pulse Rates... 105 Saturation... 105 Performance Considerations ... 106 Overview... 106 Patient Conditions... 106 Sensor Performance Considerations... 107 Reducing EMI (Electromagnetic Interference)... 109 Obtaining Technical Assistance... 110

9

Preventive Maintenance

9.1 9.2 9.3 9.4 9.5

Overview... 111 Cleaning... 111 Recycling and Disposal... 112 Battery Maintenance... 112 Periodic Safety Checks... 113

10

Modification and Testing

7.2.1 7.2.2 7.3 7.3.1 7.3.2

8.2.1 8.2.2 8.3 8.3.1 8.3.2 8.3.3 8.3.4

... 80

10.1 Overview... 115 10.2 Required Equipment... 116 10.3 System Performance Tests... 116 10.3.1 Power-On Self-Test (POST)... 116 10.3.2 Power... 117 10.3.3 Battery Charge... 118 10.3.4 Battery Discharge... 118

5

10.3.5 Patient Modes... 119 10.3.6 Date and Time... 120 10.4 Operational and Functional Tests... 121 10.4.1 General Operation Tests... 121 10.4.2 Functional Tests... 130 10.4.3 Testing Nurse Call... 146 10.5 Safety Tests... 148 10.5.1 Safety Testing Standards... 148 10.5.2 Protective Earth Continuity... 148 10.5.3 Electrical Leakage... 149 10.5.4 Verification Check Sheets... 153

11

Troubleshooting

11.1 Overview... 157 11.2 Troubleshooting Guide... 157 11.2.1 Error Conditions by Category ... 158 11.2.2 Firmware Download Errors... 164 11.2.3 Technical Alarm Conditions... 165 11.3 Return... 167

12

Repair

12.1 Overview... 169 12.2 Ordering Spare Parts... 170 12.3 Required Tools... 173 12.4 Battery Replacement... 173 12.4.1 Removing the Battery... 174 12.4.2 Replacing the Battery ... 175 12.5 Disassembly and Reassembly... 176 12.5.1 Top Cover Replacement ... 177 12.5.2 Front Bezel Replacement... 180 12.5.3 NELL1SR Board Replacement... 182 12.5.4 Main Board Replacement ... 183 12.5.5 Coin Cell Battery Replacement ... 185 12.5.6 LCD Replacement... 186 12.5.7 Control Buttons and Gasket Replacement... 188 12.5.8 Power Supply Board Replacement... 189 12.5.9 AC Inlet Replacement... 191 12.5.10 Charger Board Replacement... 192 12.5.11 Nurse Call Board Replacement... 194 12.5.12 Alarm Speaker Replacement... 196

6

List of Figures Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 4-1. Figure 4-2. Figure 4-3. 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 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 7-8. Figure 7-9. Figure 7-10. Figure 7-11. Figure 7-12. Figure 7-13. Figure 7-14. Figure 7-15. Figure 7-16. Figure 7-17. Figure 7-18. Figure 10-1. Figure 10-2. Figure 10-3. Figure 10-4.

Oxyhemoglobin Dissociation Curve ... 36 Series of SpO2 Events ... 37 First SpO2 Event: No SatSeconds Alarm ... 38 Second SpO2 Event: No SatSeconds Alarm ... 39 Third SpO2 Event: Triggers SatSeconds Alarm ... 40 Front and Side Panel Components ... 44 Display Components ... 45 Rear Panel Components ... 48 Example Initial Screen ... 59 QUICK ACCESS SpO2 Menu ... 61 QUICK ACCESS PR Menu ... 62 Volume Menu Item ... 63 Volume Selection ... 64 Response Mode Menu ... 65 Delete All Trend Data Menu Item ... 66 Service Menu Item ... 66 Service Menu Access ... 67 Service Menu ... 68 Alarm Limits Selection ... 73 Patient Mode Menu ... 74 Highlighting the Waveform Display Area ... 75 SpO2 Waveform Menu ... 76 SpO2 Waveform Menu ... 84 Tabular Trend Data Screen ... 85 Graphical Trend Data Screen ... 86 Nurse Call Interface Pin Layout ... 88 Trend Data Download Option ... 90 Trend Data Download Status ... 91 Sample Trend Data Printout ... 94 Bridge Driver Installer window ... 95 New Hardware Wizard Screen ... 96 DEVICE MANAGER Button Under Hardware Tab ... 97 Hardware list in Device Manager window ... 98 Sample Initial USB to UART Bridge Properties Window ... 99 Baud rate list under Port Settings tab ... 100 Firmware Update Mode ... 102 USB Port for Firmware Upgrade ... 102 Firmware Upgrade Read, Erase, Write Messages ... 103 Firmware Upgrade Restart Message ... 103 POST Screen and Firmware Version ... 104 Power-on Self-test Sequence ... 117 PATIENT MODE Menu ... 119 DATE/TIME Settings ... 120 Sensor Port ... 121

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

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Sensor Port ... 123 %SpO2 Lower Alarm Limit of 99 ... 124 Pulse Rate Lower Alarm Limit of 160 ... 124 ALARM AUDIO PAUSED Setting of 30 Seconds ... 125 ALARM AUDIO REMINDER Setting of 3 Minutes ... 126 ALARM VOLUME Default Setting of 5 ... 128 KEY BEEP VOLUME Default Setting of 4 ... 129 PULSE VOLUME Default Setting of 4 ... 130 SRC-MAX OxiMax Oximetry Tester ... 132 SRC-MAX Tester-Generated Waveform ... 133 SRC-MAX Increase to 200 BPM ... 133 SRC-MAX Decrease to 60 BPM ... 134 SRC-MAX %SpO2 Increase to 90 ... 135 SRC-MAX %SpO2 Decrease to 75 ... 136 SRC-MAX High Modulation ... 137 200 BPM with High Modulation ... 138 60 BPM with High Modulation ... 138 %SpO2 of 90 with High Modulation ... 139 %SpO2 of 75 with High Modulation ... 140 %SpO2 of 75 with Low Modulation ... 141 High Light Condition ... 142 200 BPM with High Light Condition ... 143 60 BPM with High Light Condition ... 143 %SpO2 of 90 with High Light Condition ... 144 %SpO2 of 75 with High Light Condition ... 145 High Modulation and High Light Condition ... 145 Nurse Call Connector ... 147 Return Packaging ... 168 Disassembly Sequence ... 170 Exploded View ... 171 Battery Replacement ... 174 Top Cover Replacement ... 178 Front Bezel Replacement ... 181 NELL1SR Board Replacement ... 182 Main Board Replacement ... 184 Cell Battery Replacement ... 186 LCD Replacement ... 187 Removing the Control Buttons and Gasket ... 188 Power Supply Board Replacement ... 190 AC Inlet Replacement ... 191 Charger Board Replacement ... 193 Nurse Call Board Replacement ... 195 Alarm Speaker Replacement ... 196

List of Tables Table 1-1. Table 2-1. Table 2-2. Table 2-3. Table 2-4. Table 2-5. Table 2-6. Table 2-7. Table 2-8. Table 2-9. Table 2-10. Table 2-11. Table 4-1. Table 5-1. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 6-5. Table 6-6. Table 7-1. Table 10-1. Table 10-2. Table 10-3. Table 10-4. Table 10-5. Table 10-6. Table 10-7. Table 10-8. Table 11-1. Table 11-2. Table 11-3. Table 12-1.

Safety Symbol Definitions... 11 Transport, Storage, and Operating Condition Ranges ... 22 Tone Definitions... 23 Trends ... 24 Pulse Oximetry Sensor Accuracy and Ranges ... 25 Sound Pressure in Decibels ... 25 Electromagnetic Emissions Guidelines ... 27 Electromagnetic Immunity Guidelines ... 27 Recommended Separation Distances ... 28 Cables and Sensors ... 30 Earth and Enclosure Leakage Current Specifications... 31 Patient Applied and Patient Isolation Risk Current ... 32 Display Colors ... 47 Standard Items ... 51 Menu Structure and Available Options ... 60 Service Menu Options ... 68 System Information... 71 Audio Status ... 78 Alarm Conditions ... 79 Parameter Ranges and Factory Defaults... 80 Operating Status Codes ... 93 Required Test Equipment ... 116 Patient Modes ... 120 Functional Tests with SRC-MAX ... 131 Nurse Call Output Resistance ... 147 Earth Leakage Current Values... 149 Enclosure Leakage Current Values ... 150 Patient Leakage Current Values... 151 Patient Leakage Current Values-Applied Part ... 152 Error Conditions and Resolutions... 158 Firmware Download Error Codes ... 164 Technical Error Codes... 165 Spare Parts List by Callout Number ... 172

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1 Introduction

1.1

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

 1.2

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

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.

1.2.1 Safety Symbols

Table 1-1. Safety Symbol Definitions Symbol

Definition WARNING Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the patient, user, or environment. Caution Cautions identify conditions or practices that could result in damage to the equipment or other property Note Notes provide additional guidelines or information.

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Introduction

1.2.2 Warnings Regarding Electric Shock and Explosion Hazards

  

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: 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.

1.2.3 Warnings Regarding Service Procedures

   

12

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. WARNING: Ensure that conductive portions of the electrodes, leads, and cable do not come into contact with any other conductive parts.

Service Manual

Safety Information

      

Service Manual

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 10, 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 Chapter 2, Product Specifications.

13

Introduction

1.2.4 Patient-Related Warnings

       

14

WARNING: Do not use any monitoring system or pulse oximetry cables, sensors, or connectors that appear damaged. WARNING: Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not touch signal input, signal output or other connectors, and the patient simultaneously. 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, potentially harming a patient or damaging the monitoring system. WARNING: To ensure patient safety, do not place the monitoring system in any location where it might drop on the patient. 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: The monitoring system is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: The measured values of the monitoring system can be affected by patient conditions, motion, sensors, environmental conditions, and nearby electromagnetic external conditions.

Service Manual

Safety Information

     

Service Manual

WARNING: The monitoring system is intended for use in a hospital or hospital-type environment by trained medical personnel. WARNING: Failure to cover the pulse oximetry sensor site with opaque material in high ambient light conditions may result in inaccurate measurements. Pulse oximetry readings and pulse signals can be affected by certain environmental conditions, pulse oximetry sensor application errors, and certain patient conditions. Refer to the appropriate sections of this manual for specific safety information. WARNING: The monitoring system is not defibrillator-proof. It may remain attached to the patient during defibrillation or during use of an electrosurgical unit; readings may be inaccurate during defibrillation and shortly thereafter. WARNING: If transferring the monitoring system from one patient to another, it may retain trend data from previous patients. WARNING: Do not silence or decrease the volume of the audible alarm if patient safety could be compromised. WARNING: Do not preset different alarm limits for the same or similar equipment within a single area.

15

Introduction

1.2.5 Cautions

    



16

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 Standard 60950-1 for data-processing equipment. All combinations of equipment must be in compliance with IEC Standard 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 Standard 60601-1:2005 and IEC Standard 60601-1-2:2007. 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.

Service Manual

Safety Information



Caution: For best product performance and measurement accuracy, use only accessories supplied or recommended by Covidien. Use accessories according to the manufacturer's directions for use and institutional standards. Use only accessories that have passed the recommended biocompatibility testing in compliance with ISO10993-1. The use of accessories, sensors, and cables other than those specified may result in inaccurate readings of the monitoring system and increased emission and/or decreased electromagnetic immunity of the monitoring system.

    

Service Manual

Caution: If the integrity of the AC power source is in doubt, ensure the monitoring system’s internal battery is fully charged. 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. Please 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.

17

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™ Bedside SpO2 Patient Monitoring System Operator’s Manual - Provides basic information for operating the monitoring system and troubleshooting errors or malfunctions. Nellcor™ Pulse Oximetry Sensor Directions 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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Service Manual

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 or 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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Introduction

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Service Manual

2 Product Specifications

2.1

Overview This chapter contains physical and operational specifications of the Nellcor™ Bedside SpO2 Patient Monitoring System. Ensure all product requirements are met prior to installation of the monitoring system.

2.2

Physical Characteristics Enclosure Weight

1.6 kg (3.5 lbs.) including battery

Dimensions

255 × 82 × 165 mm (10.04 x 3.23 x 6.50 in)

Display Screen size

109.22 mm (4.3 in), measured diagonally

Screen type

TFT LCD, white LED backlight, viewing cone of 30º and optimal viewing distance of 1 meter

Resolution

480 × 272 pixel Controls

Dial

Jog dial control

Buttons

Power On/Off, Alarm Audio Paused, Return Alarms

Categories

Patient status and system status

Priorities

Low, medium and high

Notification

Audible and visual

Setting

Default and individual

Alarm volume level

45 to 80 dB

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