Tyco
Nellcor Patient Monitoring
Bedside Respiratory Patient Monitoring System Service Manual Rev B June 2012
Service Manual
224 Pages
Preview
Page 1
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. ©2012 Covidien. All rights reserved. Microsoft and Windows EC 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 1.3
1.5 1.6
Overview...1-1 Intended Audience...1-1 Safety Information...1-1 Safety Symbols...1-1 Warnings...1-2 Cautions...1-3 Obtaining Technical Assistance...1-5 Technical Services...1-5 On-Screen Help...1-5 Related Documents ...1-5 Warranty Information...1-6
2
Product Specifications
2.1 2.2 2.3
Overview...2-1 Physical Characteristics ...2-1 Electrical Requirements...2-1 Power...2-1 Battery ...2-1 Rating of Nurse Call Relay...2-2 Environmental Conditions...2-2 Operating...2-2 Transport and Storage...2-3 Essential Performance...2-3 Sound Pressure...2-4 Product Compliance...2-4 Manufacturer’s Declaration and Guidance...2-4 Electromagnetic Compatibility (EMC)...2-4 Ground Integrity...2-9 Safety Tests...2-9
1.3.1 1.3.2 1.3.3 1.4 1.4.1 1.4.2
2.3.1 2.3.2 2.3.3 2.4 2.4.1 2.4.2 2.5 2.6 2.7 2.8 2.8.1 2.8.2 2.8.3 3
Theory of Operations
3.1 3.2 3.3 3.4
Overview...3-1 Block Diagram...3-1 Theoretical Principles...3-1 Automatic Calibration...3-2
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3.5 3.6 3.6.1 3.6.2 3.6.3 3.7 3.7.1 3.7.2 3.7.3 3.7.4 4
Functional Testers and Patient Simulators...3-3 Unique Technologies...3-4 Functional versus Fractional Saturation ...3-4 Measured versus Calculated Saturation...3-4 Data Update Period, Data Averaging, and Signal Processing .3-5 System Features...3-6 Nellcor™ Sensor Technology...3-6 SatSeconds™ Alarm Management Parameter...3-6 OxiMax SPD™ Alert Parameter...3-10 Pulse Rate Delay Alarm Management Parameter...3-12 Product Overview
4.1 4.2 4.3 4.4 4.5 4.6
Overview...4-1 Product Description...4-1 Indications for Use...4-1 List of Components ...4-2 Synopsis ...4-2 Product Views...4-3 4.6.1 Front Panel...4-3 4.6.2 Monitoring Screen...4-4 4.6.3 Rear Panel...4-6 4.7 Labeling Symbology...4-7 5
Installation
5.1 5.2 5.3
5.4
Overview...5-1 Safety Reminders...5-1 Product Setup...5-3 Mounting Options and Transport Considerations...5-3 Connection to an AC Power Source...5-3 Battery Insertion...5-4 Battery Charge...5-5 Battery Power Usage...5-6 Connection to Nellcor™ Sensors...5-7
6
Operation
5.3.1 5.3.2 5.3.3 5.3.4 5.3.5
6.1 6.2
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Overview...6-1 Power ...6-1 6.2.1 AC Power...6-2 6.2.2 Battery Power...6-2
6.2.3 Power Up...6-3 6.2.4 System Resets...6-6 6.2.5 Automatic Shutdown and Power Off...6-6 6.3 Nellcor™ Sensor Usage...6-7 6.3.1 Sensor Detection...6-7 6.3.2 Sensor Detection Failure...6-8 6.4 User Interface...6-9 6.4.1 Default Monitoring Screen and Trend Data...6-9 6.4.2 Status Messages and Alarms in the Monitoring Status Field .6-9 6.4.3 Alarm Management and Status Messages...6-10 6.4.4 Audible Alarm Management...6-13 6.4.5 Visual Alarm Management ...6-15 6.4.6 HELP Option...6-16 6.5 Service Mode ...6-16 6.5.1 Settings Menu...6-19 6.5.2 Service Menu...6-30 6.5.3 Logs Menu...6-30 6.5.4 Covidien Service Menu...6-31 6.5.5 Parameter Activation Menu...6-31 6.5.6 About Monitor Menu...6-32 7
Trend Data Access
7.1 7.2
7.5
Overview...7-1 Trend Data Management...7-1 Trend Data Basics...7-1 Data Port Connectivity...7-2 Overview...7-2 Typical Equipment Used for Connectivity...7-3 Data Port Configuration Information...7-3 Data Port Communications...7-12 Using the Nurse Call Interface...7-12 Nurse Call Feature...7-12 Setting Nurse Call RS-232 Polarity...7-14 Calculating the Analog Voltage Output...7-15
8
Performance Considerations
8.1
Overview
7.2.1 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.4 7.4.1 7.4.2
...8-1
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8.2
Oximetry Considerations...8-1 8.2.1 Monitoring System Constraints...8-1 8.2.2 Nellcor™ Sensor Performance Considerations...8-1 8.3 Patient Conditions...8-3 8.4 Reducing EMI (Electromagnetic Interference)...8-4 9 9.1 9.2 9.3 9.4 9.5
Product Maintenance Overview...9-1 Cleaning ...9-1 Periodic Safety Checks...9-1 Service and Upgrades...9-2 Storage...9-2 9.5.1 Monitoring System Transport and Storage...9-2 9.5.2 Removed Battery Storage ...9-2
10
Modification and Testing
10.1 Overview...10-1 10.2 Setting Institutional Defaults...10-5 10.3 Performance Verification...10-7 10.3.1 Overview...10-8 10.3.2 Required Equipment...10-8 10.4 Safety Testing Standards...10-8 10.5 Battery Check...10-9 10.5.1 Battery Power...10-9 10.5.2 Battery Charge...10-9 10.6 Performance Tests...10-10 10.6.1 Power-On Defaults and Alarm Ranges...10-11 10.6.2 Operational Setup...10-16 10.6.3 Overall Performance Check...10-21 10.6.4 Pulse Oximetry Functional Tests...10-23 10.6.5 Setting Nurse Call...10-39 10.7 Test Data Sheet Form...10-41 10.8 Monitoring Screen Calibration...10-43 10.9 Software and Firmware Upgrades...10-44
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11
Troubleshooting
11.1 11.2
Overview...11-1 System Condition Categories ...11-1
11.3 User Prompts and Messages...11-3 11.4 Alarms and Error Conditions...11-4 11.4.1 Alarms...11-4 11.4.2 Correctable error conditions...11-8 11.5 Power Failure Issues...11-10 11.6 Monitoring Screen Issues...11-12 11.7 Alarm Issues...11-13 11.8 Communication Issues...11-15 11.9 Operational Performance Issues...11-16 11.10 Hardware Issues...11-16 11.11 System Errors and Software issues...11-18 11.12 Non-correctable Failures...11-18 11.13 Product Return...11-19 12
Repair
12.1 Overview...12-1 12.2 Spare Parts List...12-1 12.3 Repair Prerequisites and Required Equipment...12-5 12.4 Basic Preventive Maintenance...12-6 12.4.1 Fuse Removal and Replacement...12-7 12.4.2 Battery or Battery Access Door Replacement...12-7 12.4.3 Rubber Feet Replacement...12-8 12.5 Chassis Disassembly and Reassembly...12-10 12.5.1 Parameter Module Replacement...12-10 12.5.2 Monitoring System Chassis Disassembly...12-17 12.5.3 Monitoring System Chassis Reassembly...12-20 12.6 Power Components Replacement...12-21 12.6.1 Power Entry Module (PEM) Replacement...12-22 12.6.2 Right Power Cable Assembly Replacement...12-22 12.6.3 Battery Components Replacement...12-24 12.6.4 Left Power Cable Assembly Replacement...12-31 12.7 Front Panel Components Replacement...12-32 12.7.1 Main PCB Components Replacement...12-33 12.7.2 LCD Assembly with Overlay Replacement ...12-39 12.8 Return Authorization and Shipment...12-41 12.8.1 General Instructions for Return...12-41 12.8.2 Repackage in Original Carton...12-42 12.8.3 Repackage in an Alternate Carton...12-43
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Page Left Intentionally Blank
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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 4-1. Table 4-2. Table 6-1. Table 6-2. Table 6-3. Table 6-4. Table 6-5. Table 7-1. Table 7-2. Table 7-3. Table 7-4. Table 7-5. Table 7-6. Table 7-7. Table 7-8. Table 10-1. Table 10-2. Table 10-3. Table 10-4. Table 10-5. Table 10-6. Table 10-7. Table 11-1. Table 11-2. Table 11-3. Table 11-4. Table 11-5. Table 11-6.
Safety Symbol Definitions... 1-1 Nellcor™Sensor Accuracy and Ranges... 2-3 Sound Pressure in Decibels... 2-4 Emissions Compliance and Guidance, All Systems... 2-5 Immunity Compliance and Guidance, All Systems... 2-6 Immunity Compliance and Guidance, Not Life-Supporting Equipment2-7 Recommended Separation Distance, Not Life-Supporting... 2-7 Sensor and Cable Length... 2-8 Earth and Enclosure Leakage Current Specifications... 2-9 Patient Applied and Patient Isolation Risk Current...2-10 Typical Packing List... 4-2 Labeling Symbols and Descriptions... 4-7 Battery Power Status... 6-3 Possible User Interface Settings...6-16 Possible Alarm Management Settings...6-17 Possible Data Interface Settings...6-17 Possible Service Functions...6-18 Input and Output Configuration Options... 7-2 Sample Equipment Types... 7-3 DB-15 Signal Pinouts... 7-5 RJ-45 Signal Pinouts... 7-7 USB Signal Pinouts... 7-8 Network Configuration Icons... 7-9 Nurse Call Relay Pin States...7-13 Analog Pinouts...7-15 Possible User Interface Settings...10-2 Possible Alarm Management Settings...10-2 Possible Data Interface and Service Settings...10-3 Equipment and Descriptions...10-8 Functional Tests Options... 10-25 Performance and Functional Tests... 10-41 Electrical Safety Tests... 10-42 Common User Prompts and Messages...11-4 Initial Alarm Priority for Errors...11-5 Common Correctable Problems and Resolutions...11-9 Power Failure Issues... 11-11 Monitoring Screen Issues... 11-12 Alarm Issues... 11-13
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Table 11-7. Table 11-8. Table 11-9. Table 12-1. Table 12-2. Table 12-3. Table 12-4.
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Common Prompts and Error Messages... 11-15 Common Operational Performance Issues... 11-16 Common Prompts and Error Messages... 11-16 Available Spare Parts...12-1 Required Equipment...12-6 Main PCB Connections... 12-19 Main PCB Connections... 12-33
List of Figures Figure 3-1. Figure 3-2. Figure 3-3. Figure 3-4. Figure 3-5. Figure 3-6. Figure 3-7. Figure 4-1. Figure 4-2. Figure 4-3. 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 7-1. Figure 7-2. Figure 7-3. Figure 7-4. Figure 7-5. Figure 7-6. Figure 7-7. Figure 10-1. Figure 10-2. Figure 10-3. Figure 10-4. Figure 10-5. Figure 10-6. Figure 10-7. Figure 10-8. Figure 10-9.
Block Diagram... 3-1 Oxyhemoglobin Dissociation Curve... 3-5 Series of SpO2 Events... 3-7 First SpO2 Event: No SatSeconds Alarm... 3-8 Second SpO2 Event: No SatSeconds Alarm... 3-9 Third SpO2 Event: Triggers SatSeconds Alarm... 3-10 Clinically Significant Desaturation Patterns... 3-11 Front Panel... 4-3 Sample Monitoring Screen Elements... 4-4 Rear Panel... 4-6 Sensor Cable insertion into Interface Cable... 5-7 Sample POST Splash Screen... 6-6 Sensor Type Message... 6-8 Default Monitoring Screen Layout... 6-9 Sample user prompt message: READY... 6-11 Sample status message: MONITORING... 6-11 High priority alarm: BATTERY CRITICALLY LOW... 6-11 Medium priority alarm: SpO2 LOW... 6-11 Low priority alarm: SENSOR OFF... 6-12 Sample Alarm Limit Violations... 6-13 Prompt to Enter SERVICE MODE... 6-19 Default Monitoring Screen Layout... 6-23 DB-15 Pin Layout... 7-5 RJ-45 Receptacle... 7-7 RJ-45 Pin Layout... 7-7 USB Pin Layout... 7-8 New Network Connection Windows... 7-10 New Network Connection Windows... 7-11 Nurse Call Polarity Screen... 7-14 Prompt to Enter SERVICE MODE... 10-5 Sample: Configuring Alarms...10-18 Sample: Configuring Alarms with Silenced Alarm...10-19 Sensor Identification...10-23 SRC-MAX Functional Tester...10-24 BPM Test: BPM 60 and SpO2 75...10-26 BPM Test: BPM 200 and SpO2 75...10-27 SpO2 Test: SpO2 75, BPM 60...10-28 SpO2 Test: SpO2 90, BPM 60...10-29
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Figure 10-10. MOD Test: BPM 60, SpO2 75, and MOD Low...10-30 Figure 10-11. MOD Test: BPM 60, SpO2 75, and MOD High...10-31 Figure 10-12. MOD Test: BPM 200, SpO2 75, and MOD High...10-32 Figure 10-13. MOD Test: BPM 60, SpO2 90, and MOD High...10-33 Figure 10-14. LIGHT Test: BPM 60, SpO2 75, MOD low, Light low...10-34 Figure 10-15. LIGHT Test: BPM 60, SpO2 75, MOD low, Light High...10-35 Figure 10-16. LIGHT Test: BPM 200, SpO2 75, MOD low, Light High...10-36 Figure 10-17. LIGHT Test: BPM 60, SpO2 90, MOD low, Light High...10-37 Figure 10-18. LIGHT Test: BPM 60, SpO2 90, MOD High, Light High...10-38 Figure 10-19. Initial Calibration Screen...10-43 Figure 11-1. Ready Prompt... 11-2 Figure 11-2. Sensor Disconnected Message and Help Screen... 11-2 Figure 11-3. Stacked Alarm/Alerts... 11-3 Figure 11-4. Sample Speaker Failure Message... 11-8 Figure 11-5. System Error...11-18 Figure 12-1. Exploded View of Removable Components... 12-3 Figure 12-2. Exploded View of Internal Components... 12-4 Figure 12-3. External Fuse Removal... 12-7 Figure 12-4. Battery Removal... 12-8 Figure 12-5. Rubber Feet Replacement... 12-9 Figure 12-6. Parameter Module Screw Removal...12-11 Figure 12-7. Parameter Module Tab Release...12-12 Figure 12-8. Parameter Module Assembly Removal...12-12 Figure 12-9. Parameter Module Disassembly...12-14 Figure 12-10. Parameter Board PCB and Oximetry Module Removal...12-16 Figure 12-11. Corner Chassis Screws Removal...12-18 Figure 12-12. Initial Chassis Disassembly...12-20 Figure 12-13. Right Power Cable Assembly Replacement...12-23 Figure 12-14. Battery Cradle Removal...12-25 Figure 12-15. Power Supply PCB Removal...12-27 Figure 12-16. Battery Interconnect PCB Removal...12-29 Figure 12-17. Cooling Fan Removal...12-30 Figure 12-18. Left Power Cable Assembly Replacement...12-31 Figure 12-19. Main PCB Connectors...12-34 Figure 12-20. Antennae PCB and UFL Connectors Removal...12-36 Figure 12-21. Single Board Computer (SBC) Removal...12-37 Figure 12-22. Flash Driver PCB Removal...12-38 Figure 12-23. LCD Assembly Removal...12-40 Figure 12-24. Components to Repackage in Original Carton...12-42
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1 Introduction
1.1
Overview This manual contains information for collecting patient oxygen saturation data while operating the Nellcor™ Bedside Respiratory Patient Monitoring System.
1.2
Intended Audience This manual provides information to professionals acting as trained and qualified service technicians in a hospital or hospital-type setting for maintenance and service or repair of the monitoring system. Refer to the institution for any additional training or skill requirements beyond those identified here for maintenance and repair of the monitoring system. Before servicing, thoroughly read this manual.
1.3
Safety Information
1.3.1 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 alert users to exercise appropriate care for safe and effective use of the product. Note Notes provide additional guidelines or information.
1-1
Introduction
1.3.2 Warnings
1-2
WARNING: Explosion hazard - Do not use in the presence of flammable anesthetics. WARNING: Shock hazard - Use only when connected to a grounded outlet to avoid electric shock. WARNING: Before attempting to open or disassemble, disconnect the power cord to avoid possible injury. WARNING: Use only Covidien-approved internal batteries. WARNING: The monitoring system is not defibrillator-proof. It may remain attached to the patient during defibrillation or during use of an electrosurgical unit, however, readings may be inaccurate during use in this environment and shortly thereafter. WARNING: Supplemental oxygen will attenuate patterns of desaturation. A patient’s respiratory compromise can be proportionally more severe before patterns appear in the saturation trend. Remain vigilant when monitoring a patient on supplemental oxygen. WARNING: Do not silence or disable audible alarms or decrease the volume of the audible alarm if patient safety could be compromised. Do not dim or disable visual alarms if patient safety could be compromised. WARNING: Ensure the monitoring system is clear of any obstructions that prevent awareness of visual or audible alarms. Failure to do so may result in inadvertently missing a visual alarm or an inaudible alarm tone.
Service Manual
Safety Information
WARNING: Do not use any monitoring system, sensor, cable, or connector that appears damaged. Remove any damaged equipment from service for inspection by a qualified service technician. WARNING: Do not lift by the sensor or interface cable. The cable may disconnect, potentially dropping the monitoring system on a patient or damaging surface. WARNING: When installing the AC power cord, ensure the cord is carefully positioned to prevent tripping and entanglement. WARNING: 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. WARNING: To ensure accurate performance and prevent device failure, do not subject to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure. WARNING: The monitoring screen contains toxic chemicals. Do not touch a broken enclosure or monitoring screen. Physical contact with a broken enclosure or monitoring screen can result in transmission or ingestion of toxic substances. WARNING: No user serviceable parts inside.
1.3.3 Cautions
Service Manual
Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
1-3
Introduction
1-4
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 utilize a grounded outlet. Any equipment connected to the data interface must be certified according to the latest IEC/EN 60950 -1 standard for data-processing equipment, the latest IECEN 60601-1 standard for electromedical equipment, or the latest IEC/EN safety standards relevant to that equipment. All combinations of equipment must be in compliance with Requirements for Medical Electrical Systems IEC Standard 60601-1:2007and the electromagnetic compatibility IEC/EN Standard 60601-1:2005. Anyone who connects equipment to the data interface is configuring a medical system and, therefore, is responsible for ensuring that the system complies with the Requirements for Medical Electrical Systems IEC/EN Standard 60601-1-1:2007 and the electromagnetic compatibility IEC/ EN Standard 60601-1-2:2007. Accuracy may degrade if it is connected to secondary I/O devices when the equipment is not connected to earth reference. Caution: Observe electrostatic discharge (ESD) precautions prior to opening the chassis or handling any internal components. Caution: Observe the required torque for tightening screws. Over-tightening can strip out screw holes, rendering them useless.
Service Manual
Obtaining Technical Assistance
1.4
Obtaining Technical Assistance
1.4.1 Technical Services
For technical information and assistance, if unable to correct a problem while using the monitoring system, to order parts, or to order an Operator’s or Service Manual, 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 (toll) or contact a local Covidien representative www.covidien.com
When calling Covidien or a local Covidien representative, have the serial number, as well as the code versions available. To locate the serial number and code versions 1. Press MENU. 2.
Press ABOUT THE MONITOR.
3.
Locate the serial number under Monitor Information and code versions under Software Information.
1.4.2 On-Screen Help
The monitoring system provides users with an on-screen help system for various help topics. Reference To access on-screen help topics, p. 6-16. 1.5
Related Documents Documentation is available online at www.covidien.com. Covidien makes available all appropriate information relevant to servicing monitoring system parts designated as repairable in this manual. For further assistance, contact Covidien.
Service Manual
1-5
Introduction
1.6
•
The Nellcor™ Bedside Respiratory Patient Monitoring System Operator’s Manual - Provides basic information on operating the monitoring system and troubleshooting errors or malfunctions. Before using the monitoring system, thoroughly read this manual.
•
Nellcor™ Sensor Instructions for Use - Guides sensor selection and usage. Before attaching any of the various Covidien-approved Nellcor™ sensors to the monitoring system, refer to their Instructions for Use.
•
Saturation Accuracy Grid - Provides sensor-specific guidance related to desired SpO2 saturation accuracy measurements.
•
The Nellcor™ Bedside Respiratory Patient Monitoring System Service Manual - Provides information to qualified service technicians for use when modifying, testing, troubleshooting, repairing, and upgrading the monitoring system.
Warranty Information To obtain information, contact Covidien or a local Covidien representative. Purchase of this instrument confers no express or implied license under any Covidien patent to use that instrument with any sensor not manufactured or licensed by Covidien llc.
1-6
Service Manual
2 Product Specifications
2.1
Overview This chapter contains physical and operational specifications of the Nellcor™ Bedside Respiratory Patient Monitoring System. Ensure all product requirements are met prior to installation.
2.2
2.3
Physical Characteristics Weight
7.5 lbs. (3.4 kg)
Dimensions
10 in. x 6.5 in. x 5 in. (252 mm x 163 mm x 122 mm)
Electrical Requirements
2.3.1 Power
Power Requirements
Rated at 100 to 240 volts AC (nominal 120-230 VAC), 30 VA
Input Frequency
50/60 Hz
Fuses
Slow-blow 1.5 amp, 250 volts, IEC (5 x 20 mm) Quantity: 2 external
2.3.2 Battery
Note: The battery provides approximately seven hours of battery life when new and fully-charged with no alarms, no serial data, no analog output, no nurse call output, with backlight on while using a pulse simulator set for 200 bpm, high light and low modulation.
2-1
Product Specifications
Type
Lithium Ion
Voltage
7.2 Volts DC, 11.6 Ah, 83 Wh
Recharge
8 hours with monitoring system turned off 12 hours with monitoring system turned on
Shelf Life
Four months, if monitoring system runs on new, fully-charged battery After four months storage, units run 33% of stated battery life
Compliance
91/157/EEC
2.3.3 Rating of Nurse Call Relay
2.4
Maximum Input Voltage
30 VAC or VDC (polarity is not important)
Load Current
120 mA continuous (peak 300 mA @ 100 ms)
Minimum Resistance
26.5 ohms to 50.5 ohms (40.5 ohms typical) during alarms
Ground Reference
Isolated Ground
Electrical Isolation
1500 Volts
Environmental Conditions
2.4.1 Operating
2-2
Temperature
5 ºC to 40 ºC (41 ºF to 104 ºF)
Altitude
-390 m to 3,012 m (-1,254 ft. to 9,882 ft.)
Atmospheric Pressure
70 kPa to 106 kPa (20.6 in. Hg to 31.3 in. Hg)
Relative Humidity
15% to 95% non-condensing
Service Manual
Essential Performance
2.4.2 Transport and Storage
Not in shipping container
In shipping container
-20 ºC to 60 ºC (-4 ºF to 140 ºF)
-20 ºC to 70 ºC (-4 ºF to 158 ºF)
Temperature Altitude
-390 m to 5,574 m (-1,254 ft. to 18,288 ft.)
Atmospheric Pressure
50 kPa to 106 kPa (14.7 in. Hg to 31.3 in. Hg)
Relative Humidity
2.5
15% to 95% non-condensing
Essential Performance This monitoring system has the capability to detect physiological alarm conditions using SpO2 accuracy, pulse rate accuracy and alarm limit conditions. Table 2-1. Nellcor™Sensor Accuracy and Ranges Type
Values Measurement Ranges
SpO2 saturation range
1% to 100%
Pulse rate range
20 to 250 beats per minute (bpm)
Perfusion range
0.03% to 20% Measurement Accuracy
Pulse rate accuracy
20 to 250 beats per minute (bpm) ±3 digits
SpO2 saturation accuracy1
70% to 100% ±2 to ±3 digits
Operating Range and Dissipation Red Light Wavelength
Approximately 660 nm
Infrared Light Wavelength
Approximately 900 nm
Optical Output Power
Less than 15 mW
Power Dissipation
52.5 mW
1. Monitoring system measurements are statistically distributed; about two-thirds of monitoring system measurements can be expected to fall in this accuracy (ARMS) range. Reference the Clinical Studies section in the Operator’s Manual for test results. For a complete listing and for test results of SpO2 accuracy across the full line of available Nellcor™ sensors, contact Covidien, a local Covidien representative, or locate it online at www.covidien.com.
Service Manual
2-3