Nellcor
Nellcor Patient Monitoring
Bedside SpO2 Patient Monitoring System Operators Manual Rev B Dec 2018
Bedside SpO2 Patient Monitoring System Operators Manual Rev B Dec 2018
160 Pages
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© 2018 Covidien. All rights reserved. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG. ™* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company.
Table of Contents 1
Introduction
1.1 1.2
1.4
Overview...1-1 Safety Information...1-1 Safety Symbols...1-1 Warnings...1-2 Cautions...1-4 Technical Assistance...1-6 Technical Services...1-6 Related Documents...1-6 Warranty Information...1-7
2
Product Overview
2.1 2.2 2.3 2.4
Overview...2-1 Product Description...2-1 Indications for Use...2-2 Product Views...2-3 Front Panel and Display Components...2-3 Rear Panel ...2-7 Product and Carton Label Symbols...2-8
1.2.1 1.2.2 1.2.3 1.3 1.3.1 1.3.2
2.4.1 2.4.2 2.4.3 3
Installation
3.1 3.2 3.3 3.4
3.5
Overview...3-1 Safety Reminders...3-1 Unpacking and Inspection...3-2 Power...3-3 AC Power Connection...3-3 Internal Battery Power...3-4 Nellcor™ Pulse Oximetry Sensor Connection...3-5
4
Operation
4.1 4.2 4.3
Overview...4-1 Safety Reminders...4-1 Apply Power to Monitoring System...4-2 Turn On the Monitoring System...4-2 Turn Off the Monitoring System...4-3 Menu Navigation...4-4 Choose Patient Settings...4-5
3.4.1 3.4.2
4.3.1 4.3.2 4.4 4.5
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4.5.1 4.5.2 4.5.3
4.9 4.10
Set Patient Mode (Type)...4-5 Set SpO2 and Pulse Rate Alarm Limits...4-5 Set SpO2 WAVEFORM...4-9 Manage Alarms and Alarm Limits... 4-10 Audible Alarm Indicators... 4-11 Visual Alarm Indicators... 4-12 Set Additional Patient Modes... 4-13 Mode (Response Mode)... 4-13 Homecare Mode... 4-14 Sleep Study Mode... 4-15 Standard Mode... 4-17 Select Optional Settings... 4-18 Volume... 4-18 Brightness... 4-19 Menu Structure and Factory Defaults... 4-20 Maintenance Reminder... 4-22
5
Data Management
5.1 5.2 5.3 5.4
Overview...5-1 Tabular Trend Data...5-1 Graphical Trend Data...5-2 External Data Communication...5-3 Nurse Call Interface...5-3 Trend Data Download...5-5 Firmware Upgrades... 5-16
4.6 4.6.1 4.6.2 4.7 4.7.1 4.7.2 4.7.3 4.7.4 4.8 4.8.1 4.8.2
5.4.1 5.4.2 5.4.3 6
Performance Considerations
6.1 6.2
Overview...6-1 Oximetry Considerations...6-1 Pulse Rates...6-1 Saturation...6-1 Performance Considerations...6-2 Overview...6-2 Patient Conditions...6-2 Sensor Performance Considerations...6-3 Reducing EMI (Electromagnetic Interference)...6-5 Obtaining Technical Assistance...6-6
6.2.1 6.2.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.4
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7
Preventive Maintenance
7.1 7.2 7.3 7.4 7.5 7.6
Overview...7-1 Cleaning...7-1 Recycling and Disposal...7-2 Battery Maintenance...7-2 Periodic Safety Checks...7-4 Service...7-4
8
Troubleshooting
8.1 8.2 8.3 8.4
Overview...8-1 General...8-1 Error Conditions...8-2 Return...8-4
9
Accessories
9.1 9.2 9.3 9.4
Overview...9-1 Nellcor™ Pulse Oximetry Sensors...9-1 Optional Equipment...9-4 Biocompatibility Testing...9-4
10
Theory of Operations
10.1 Overview... 10-1 10.2 Theoretical Principles... 10-1 10.3 Automatic Calibration... 10-2 10.4 Functional versus Fractional Saturation... 10-2 10.5 Measured versus Calculated Saturation... 10-3 10.6 SatSeconds™ Alarm Management Feature... 10-4 10.6.1 First SpO2 Event... 10-5 10.6.2 Second SpO2 Event... 10-6 10.6.3 Third SpO2 Event... 10-7 10.6.4 The SatSeconds™ Safety Net... 10-8 11
Product Specifications
11.1 11.2 11.3
Overview... 11-1 Physical Characteristics... 11-1 Electrical Requirements... 11-2
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11.4 11.5 11.6 11.7 11.8 11.8.1 11.8.2 11.8.3 11.9
Environmental Conditions... 11-2 Tone Definition... 11-3 Performance Specifications... 11-4 Product Compliance... 11-7 Manufacturer’s Declaration and Guidance... 11-7 Electromagnetic Compatibility (EMC)... 11-7 Sensor and Cable Compliance... 11-14 Safety Tests... 11-14 Essential Performance... 11-17
A
Clinical Studies
A.1 A.2
Overview... A-1 Methodology... A-1 Hypoxia Methodology (Accuracy, Low Saturation, and Motion Studies)... A-1 Low Saturation Methodology (Low Saturation Study Only)... A-2 Motion Methodology (Motion Study Only)... A-2 Results... A-2 Accuracy Results (No Motion)... A-2 Accuracy Results (Low Saturation)... A-23 Accuracy Results (Motion)... A-28 Conclusion... A-37 No Motion... A-37 Motion... A-37
A.2.1 A.2.2 A.2.3 A.3 A.3.1 A.3.2 A.3.3 A.4 A.4.1 A.4.2
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List of Tables Table 1-1. Safety Symbol Definitions...1-1 Table 2-1. Display Colors...2-7 Table 2-2. Symbol Descriptors ...2-8 Table 3-1. Standard Items...3-2 Table 4-1. Alarm Conditions ... 4-10 Table 4-2. Audio Status... 4-12 Table 4-3. Menu Structure and Factory Defaults... 4-20 Table 4-4. Service Menu Settings (Password Protected)... 4-21 Table 5-1. Nurse Call Relay Pins States for NORMALLY + ...5-5 Table 5-2. Nurse Call Relay Pins States for NORMALLY – ...5-5 Table 5-3. Status Codes ... 5-10 Table 8-1. Common Problems and Resolutions ...8-2 Table 9-1. Nellcor™ Pulse Oximetry Sensor Models and Patient Sizes ...9-2 Table 11-1. Transport, Storage, and Operating Condition Ranges... 11-2 Table 11-2. Tone Definitions... 11-3 Table 11-3. Trends ... 11-4 Table 11-4. Nellcor™ Sensor Accuracy and Ranges ... 11-5 Table 11-5. Nellcor™ Sensor Operating Ranges and Power Dissipation... 11-6 Table 11-6. Electromagnetic Emissions Guidelines and Compliance ... 11-9 Table 11-7. Electromagnetic Immunity Guidelines and Compliance ... 11-10 Table 11-8. Recommended Separation Distance Calculations ... 11-11 Table 11-9. Recommended Separation Distances... 11-12 Table 11-10. Test Specifications for Enclosure Port Immunity to RF Wireless Communications Equipment... 11-13 Table 11-11. Cables and Sensors... 11-14 Table 11-12. Earth Leakage and Touch Current ... 11-15 Table 11-13. Patient Leakage Current ... 11-16 Table A-1. SpO2 Accuracy Results (No Motion) ... A-3 Table A-2. Pulse Rate Accuracy Results (No Motion)... A-4 Table A-3. RMSD of SpO2 per Decade (No Motion)... A-22 Table A-4. RMSD of SpO2 per Plateau (No Motion)... A-23 Table A-5. SpO2 Accuracy Results (60 to 80% SaO2)... A-23 Table A-6. Pulse Rate Accuracy Results (60 to 80% SaO2) ... A-23 Table A-7. RMSD of SpO2 per Decade (Low Saturation)... A-27 Table A-8. RMSD of SpO2 per Plateau (Low Saturation)... A-27 Table A-9. SpO2 Accuracy Results During Motion... A-28 Table A-10. Pulse Rate Accuracy Results During Motion... A-28 Table A-11. Percent Modulation During Motion... A-36 Table A-12. RMSD of SpO2 per Decade (Motion)... A-36 Table A-13. RMSD of SpO2 per Plateau (Motion) ... A-37
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List of Figures Figure 2-1. Figure 2-2. Figure 2-3. Figure 3-1. 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 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. Figure 5-11. Figure 5-12. Figure 10-1. Figure 10-2. Figure 10-3. Figure 10-4.
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Front and Side Panel Components ...2-3 Display Components ...2-4 Rear Panel Components...2-7 Connecting a Pulse Oximetry Sensor to Interface Cable...3-6 Sample Initial Screen ...4-3 Save Change Screen ...4-5 SpO2 QUICK ACCESS Menu ...4-7 QUICK ACCESS PR Menu ...4-8 ALARM/LIMITS Menu Options...4-8 Waveform Display Area Highlighted ...4-9 SpO2 Waveform Menu ...4-9 Response Mode Menu ... 4-13 Switch to Homecare Mode... 4-14 Password Entry for Homecare Mode ... 4-14 Delete or Save Trend Data... 4-15 Sensor Messages... 4-15 Homecare Mode Main Screen with Homecare Icon ... 4-15 Switch to Sleep Study Mode... 4-16 “Disabling of Alarms” Message... 4-16 Password Entry for Sleep Study Mode ... 4-16 Sleep Study Mode Main Screen... 4-17 Volume Menu Item... 4-18 Volume Selection... 4-18 Brightness Menu Item... 4-19 Brightness Selection ... 4-19 Tabular Trend Data Screen...5-1 Graphical Trend Data Screen...5-2 Nurse Call Interface Pin Layout...5-4 Trend Data Download Option...5-7 Trend Data Download Status ...5-7 Sample Trend Data Printout ...5-9 Sample Bridge Driver Installer window ... 5-11 Sample New Hardware Wizard Screen... 5-12 Sample Device Manager Button Under Hardware Tab... 5-13 Sample Hardware List in Device Manager Window ... 5-14 Sample Initial USB to UART Bridge Properties Window... 5-15 Sample Baud rate list under Port Settings tab ... 5-16 Oxyhemoglobin Dissociation Curve ... 10-3 Series of SpO2 Events ... 10-4 First SpO2 Event: No SatSeconds™ Alarm ... 10-5 Second SpO2 Event: No SatSeconds™ Alarm... 10-6
Figure 10-5. Figure A-1. Figure A-2. Figure A-3. Figure A-4. Figure A-5. Figure A-6. Figure A-7. Figure A-8. Figure A-9. Figure A-10. Figure A-11. Figure A-12. Figure A-13. Figure A-14. Figure A-15. Figure A-16. Figure A-17. Figure A-18. Figure A-19. Figure A-20.
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Third SpO2 Event: Triggers SatSeconds™ Alarm... 10-7 Modified Bland-Altman for SpO2 (All Data - No Motion): SaO2 vs. (SpO2 - SaO2) ... A-5 Modified Bland-Altman for Pulse Rate (All Data - No Motion): ECG HR vs. (Pulse Rate - ECG HR)... A-6 Modified Bland-Altman for SpO2 - MAXA Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) ... A-7 Modified Bland-Altman for SpO2 - MAXN Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) ... A-8 Modified Bland-Altman for SpO2 - MAXFAST Sensor (No Motion): SaO2 vs. (SpO2 - SaO2)... A-9 Modified Bland-Altman for SpO2 - SC-A Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) ... A-10 Modified Bland-Altman for SpO2 - DS-100A Sensor (No Motion): SaO2 vs. (SpO2 - SaO2)... A-11 Modified Bland-Altman for SpO2 - OxiCliq-A Sensor (No Motion): SaO2 vs. (SpO2 - SaO2)... A-12 Modified Bland-Altman for SpO2 - D-YSE Sensor (No Motion): SaO2 vs. (SpO2 - SaO2) ... A-13 Modified Bland-Altman for Pulse Rate - MAXA Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-14 Modified Bland-Altman for Pulse Rate - MAXN Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-15 Modified Bland-Altman for Pulse Rate - MAXFAST Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-16 Modified Bland-Altman for Pulse Rate - SC-A Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-17 Modified Bland-Altman for Pulse Rate - DS-100A Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-18 Modified Bland-Altman for Pulse Rate - OxiCliq-A Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-19 Modified Bland-Altman for Pulse Rate - D-YSE Sensor (No Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-20 Correlation Plot for SpO2 (All Data - No Motion): SaO2 vs. SpO2 ... A-21 Correlation Plot for Pulse Rate (All Data - No Motion): ECG HR vs. Pulse Rate ... A-22 Modified Bland-Altman for SpO2 (All Data - Low Saturation): SaO2 vs. (SpO2 - SaO2) ... A-24 Modified Bland-Altman for Pulse Rate (All Data Low Saturation): ECG HR vs. (Pulse Rate - ECG HR)... A-25
Figure A-21. Correlation Plot for SpO2 (All Data - Low Saturation): SaO2 vs. SpO2 ... A-26 Figure A-22. Correlation Plot for Pulse Rate (All Data - Low Saturation): ECG HR vs. Pulse Rate ... A-27 Figure A-23. Modified Bland-Altman for SpO2 (All Data - Motion): SaO2 vs. (SpO2 - SaO2) ... A-29 Figure A-24. Modified Bland-Altman for Pulse Rate (All Data - Motion): ECG HR vs. (Pulse Rate - ECG HR)... A-30 Figure A-25. Modified Bland-Altman for SpO2 - MAXA Sensor (Motion): SaO2 vs. (SpO2 - SaO2) ... A-31 Figure A-26. Modified Bland-Altman for SpO2 - MAXN Sensor (Motion): SaO2 vs. (SpO2 - SaO2) ... A-32 Figure A-27. Modified Bland-Altman for Pulse Rate - MAXA Sensor (Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-33 Figure A-28. Modified Bland-Altman for Pulse Rate - MAXN Sensor (Motion): ECG HR vs. (Pulse Rate - ECG HR) ... A-34 Figure A-29. Correlation Plot for SpO2 (All Data - Motion): SaO2 vs. SpO2 ... A-35 Figure A-30. Correlation Plot for Pulse Rate (All Data - Motion): ECG HR vs. Pulse Rate ... A-35
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1 Introduction
1.1
Overview This manual contains information for operating the Nellcor™ bedside SpO2 patient monitoring system. This manual applies to the following product:
1.2
PM100N
Note: Before use, carefully read this manual, accessory Instructions 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 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.
1-1
Introduction
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 manufacturer's batteries. Do not use different types or models of batteries such as dry batteries, nickel-metal hydride batteries, or Lithium-ion batteries together. WARNING: Do not use any monitoring system or pulse oximetry cables, sensors, or connectors that appear damaged. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: Do not simultaneously touch the patient and the signal input, signal output, or any other connectors. 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. WARNING: To ensure patient safety, do not place the monitoring system in any location where it might drop on the patient. 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.
Operator’s Manual
Safety Information
Operator’s 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: 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 values displayed by the monitoring system can be affected by patient conditions, excessive patient movement, sensors, environmental conditions, and nearby external electromagnetic conditions. WARNING: When the monitoring system is set to Standard Mode, it 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. Refer to the appropriate sections of this manual for specific safety information. 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: The monitoring system may retain trend data from multiple patients if transferred from one patient to another. 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.
1-3
Introduction
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.
1.2.3 Cautions
1-4
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: 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.
Operator’s Manual
Safety Information
Operator’s Manual
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 ISO 10993-1. Caution: Where the integrity of the external protective conductor in the installation or its arrangement is in doubt, the monitoring system operates from its battery. 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. 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: Follow local government ordinances and recycling instructions regarding disposal or recycling of device components, including its accessories.
1-5
Introduction
1.3
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. Provide the firmware version number listed at power-on self-test (POST). 1.3.2 Related Documents
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. Provide this guide to home caregivers and recommend that they use it. 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 Instructions for Use. Saturation Accuracy Grid - Provides sensor-specific guidance related to desired SpO2 saturation accuracy measurements. Available online at www.covidien.com. Nellcor™ Bedside SpO2 Patient Monitoring System Service Manual - Provides information to qualified service technicians who are servicing the monitoring system.
1-6
Operator’s Manual
Warranty Information
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 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.
Operator’s Manual
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Introduction
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Operator’s Manual
2 Product Overview
2.1
Overview WARNING: Patient conditions may result in erroneous readings. If the measurements are suspect, verify the reading using another clinically accepted measurement method.
This chapter contains basic information about the Nellcor™ bedside SpO2 patient monitoring system. The monitoring system relies on unique oximetry technology and design to provide hospitals, clinicians, and caregivers accurate, timely data, which includes a number of parameters.
2.2
•
Arterial blood oxygen saturation (SpO2) - Functional measure of oxygenated hemoglobin relative to the sum of oxyhemoglobin and deoxyhemoglobin
•
Pulse rate (PR) - Detected heart pulsations in beats per minute
•
Plethysmographic waveform (Pleth) - A non-normalized waveform that represents relative pulsatile strength
•
Operating status - State of the monitoring system, including alarm conditions and messages
•
Patient data - Real-time trend data on the current patient
•
Sensor messages - Detected real-time information on attached patient sensor
Product Description The Nellcor™ bedside SpO2 patient monitoring system provides continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
2-1