Operators Manual
151 Pages
Preview
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Nellcor Puritan Bennett Incorporated is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, MAX-FAST, and OXIMAX are trademarks of Nellcor Puritan Bennett Incorporated or an affiliate. Cet appareil ISM est conforme à la norme NMB-001 Canada. To obtain information about a warranty, if any, contact Nellcor’s Technical Services Department, or your local representative. Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett. Covered by one or more of the following U.S. Patents and foreign equivalents: 4,802,486; 4,869,254; 4,928,692; 4,934,372; 4,960,126; 5,078,136; 5,485,847; 5,743,263; 5,865,736; 6,035,223; 6,298,252; 6,463,310; 6,591,123; 6,675,031; 6,708,049; 6,801,797; and Re.35,122.
Contents Safety Information ... 1 Warnings ... 1 Cautions ... 4 Notes ... 5
Introduction ... 7 Intended Use for the OXIMAX N-65 ... 7 How to Use this Manual ... 7
Symbols, Controls, Displays, and Indicators ... 9 Front Panel Description ... 9 Front Panel Symbols ... 13 Rear Panel Symbols ... 14 Label Symbols ... 15 Controls ... 16 Displays and Indicators ... 19 Audible Indicators ... 24
Set up the OXIMAX N-65 ... 25 List of Components ... 27 Connect OXIMAX Sensor to the Monitor ... 27 Inaccurate Monitor Measurements ... 28
Battery Operation ... 31 Battery Power ... 31 Low Battery Indicator ... 31 Critical Battery Indication ... 32 Battery Installation ... 33
OXIMAX N-65 Operation ... 35 Introduction ... 35 Turn On the OXIMAX N-65 ... 36 Discussion ... 36 Procedure ... 37 OXIMAX Sensor Attached ... 41 No OXIMAX Sensor Attached ... 42 OXIMAX N-65 Operator’s Manual
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Backlight On/Off ... 43 Adjust Pulse Beep Volume ... 43 Discussion ... 43 Procedure - During Monitoring ... 44 Procedure - Using Menu Structure ... 45 Adjust Alarm Volume ... 46 Discussion ... 46 Procedure ... 46 Set Time and Date ... 48 Discussion ... 48 Procedure ... 49 Set Alarm Silence Duration ... 53 Discussion ... 53 Procedure ... 53 Disable Audible Alarms ... 54 Discussion ... 54 Procedure ... 55 Set Alarm Limits ... 56 Discussion ... 56 Procedure ... 57 Alarm Limit Changed Indicator ... 61 Record Snap-Shot Data ... 61 Discussion ... 61 Procedure ... 62 Print Data ... 63 Discussion ... 63 Print Mode ... 65 After Printing Data ... 65 Procedure ... 67
OXIMAX Sensor Event Record ... 69 Event Records ... 69
OXIMAX Sensors and Accessories ... 71 Select an OXIMAX Sensor ... 71 OXIMAX Sensor Features ... 76 Biocompatibility Test ... 77 Optional Accessories ... 77 Rubber Boot With Clip ... 78 Functional Thermoformed Holster ... 79 Carrying Case ... 80 Water-Resistant Jacket ... 81 ii
OXIMAX N-65 Operator’s Manual
Infrared Printer ... 82 Thermal Paper ... 83 DEC-4 Extension Cable ... 84 Transport Boot ... 85
Performance Considerations ... 87 Performance Verification ... 87 OXIMAX N-65 Performance Considerations ... 87 Dysfunctional Hemoglobins ... 88 Anemia ... 88 Saturation ... 88 Pulse Rates ... 88 OXIMAX Sensor Performance Considerations ... 89
Troubleshooting ... 93 Error Codes ... 93 Corrective Action ... 95 EMI (Electromagnetic Interference) ... 99 Technical Assistance ... 100
Maintenance ... 103 Return the OXIMAX N-65 ... 103 Service ... 104 Periodic Safety Checks ... 104 Cleaning ... 105
Menu Structure ... 107 Set Menus Quick Reference ... 107 Set Menu Parameters ... 108 Set Time/Date Parameters ... 110
Principles of Operation ... 113 Oximetry Overview ... 113 Automatic Calibration ... 114 Functional versus Fractional Saturation ... 115 Measured versus Calculated Saturation ... 115 OXIMAX Technology ... 116 Functional Testers and Patient Simulators ... 117
Specifications ... 119 Performance ... 119
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Electrical ... 126 Environmental Conditions ... 128 Physical Characteristics ... 129 Compliance ... 129 Manufacturer’s Declaration ... 130
Index ... 137
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OXIMAX N-65 Operator’s Manual
Safety Information Warnings
Warnings are identified by the WARNING symbol shown above. Warnings alert the user to potential serious outcomes, such as death, injury, or adverse events to the patient or user. WARNING: The OXIMAX sensor uses the date and time provided by the OXIMAX N-65 handheld pulse oximeter when the sensor event record is recorded by the sensor. The accuracy of the date/time is dependent on the date/time already set in and provided by the OXIMAX N-65.
WARNING: Explosion hazard. Do not use the OXIMAX N-65 in the presence of flammable anesthetics mixture with air, oxygen, or nitrous oxide.
WARNING: Chemicals from a broken LCD display panel are toxic when ingested. Use caution when the OXIMAX N-65 has a broken display panel.
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Safety Information
WARNING: Routinely monitor the patient to make sure the OXIMAX N-65 is functioning and the sensor is correctly placed.
WARNING: Pulse oximetry measurements and pulse signals can be affected by certain environmental conditions, OXIMAX sensor application errors, and certain patient conditions. See the appropriate sections of this manual for specific safety information.
WARNING: The use of accessories, sensors, and cables other than those specified may result in increased emission and/or create invalid readings of the OXIMAX N-65.
WARNING: Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements.
WARNING: Do not silence the audible alarm function, or decrease the audible alarm volume, if patient safety could be compromised.
WARNING: The OXIMAX N-65 is a prescription device to be operated only by trained personnel. The monitor is for attended monitoring only.
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OXIMax N-65 Operator’s Manual
Safety Information
WARNING: Dispose of batteries in accordance with local ordinances and regulations.
WARNING: The OXIMAX N-65 is not defibrillator-proof. However, it may remain attached to the patient throughout defibrillation or while an electrosurgical unit is in use. The measurements may be inaccurate throughout the defibrillation, or use of an electrosurgial unit, and shortly thereafter. To avoid shock, the caregiver should not hold the OXIMAX N-65 while using a defibrillator on a patient.
WARNING: Disconnect the OXIMAX N-65 and Nellcor OXIMAX sensor from the patient throughout magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.
WARNING: To ensure accurate performance and prevent device failure, do not subject the OXIMAX N-65 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure.
WARNING: Do not use an OXIMAX N-65, OXIMAX sensor, or cables that appear damaged.
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Safety Information
WARNING: Do not lift the OXIMAX N-65 by the sensor or extension cable because the cable could disconnect from the monitor and the monitor may drop on the patient.
Cautions
Cautions are identified by the CAUTION symbol shown above. Cautions alert the user to exercise care necessary for the safe and effective use of the OXIMAX N-65 handheld pulse oximeter. Caution: All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements. Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
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Safety Information
Notes
Notes are identified by the Note symbol shown above. Notes contain important information that may otherwise be overlooked or missed.
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Safety Information
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Introduction
WARNING: Do not make any clinical judgments based solely on the OXIMAX N-65. The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
Intended Use for the OXIMAX N-65 The OXIMAX™ N-65 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities, transport and mobile environments as well as in the home care environment.
How to Use this Manual All users should read this manual thoroughly. More experienced users of the monitor can refer directly to the topics for the information they require. The current copy of this manual is available on the internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html
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Introduction
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Symbols, Controls, Displays, and Indicators Front Panel Description This section identifies the symbols, controls, displays, and indicators on the OXIMAX N-65.
1 - %SpO2 area of display 2 - Measured %SpO2 3 - Pulse beats per minute (BPM) area of display 4 - Measured BPM
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Symbols, Controls, Displays, and Indicators
5 - %SpO2 Lower Alarm Limit indicator 6 - %SpO2 Upper Alarm Limit indicator 7 - Pulse Amplitude indicator (Blip bar) 8 - Time Colon time/date field separator 9 - Adjust Time mode indicator 10 - Adjust Volume mode indicator 11 - Set Limit mode indicator 12 - BPM Upper Alarm Limit indicator 13 - BPM Limit Changed indicator 14 - Sensor Off Patient indicator 15 - Sensor Disconnected indicator 16 - %SpO2 Limit Changed indicator
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Symbols, Controls, Displays, and Indicators
17 - Low Battery indicator 18 - Data In-Sensor indicator 19 - Alarm Volume Adjust indicator 20 - Pulse Beep Tone Volume Adjust indicator 21 - BPM Lower Alarm Limit indicator 22 - Print indicator 23 - Interference indicator 24 - Pulse Search indicator 25 - Data indicator 26 - Alarm Silenced indicator
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Symbols, Controls, Displays, and Indicators
27 - Power button 28 - Up Arrow button 29 - Backlight button 30 - Menu button 31 - Data (Record/Print) button 32 - Down Arrow button 33 - Alarm Silence button
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Symbols, Controls, Displays, and Indicators
Front Panel Symbols The following two symbols are located on the front panel of the monitor.
Displays the measured percent of oxygen saturation. Displays the measured pulse beats per minute.
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Symbols, Controls, Displays, and Indicators
Rear Panel Symbols The following symbols are located on the rear panel of the monitor.
1 - Label 2 - Battery Cover
See Instructions for Use
Type BF Applied Part - Not defibrillator proof
Resistant to liquid ingress
Rx Prescription only
Date of Manufacture
European union approval
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Symbols, Controls, Displays, and Indicators
Canadian/USA certification mark (electrical safety)
Russian regulatory approval
Serial number
Label Symbols These symbols display on the monitor’s labels.
Keep away from heat
Temperature limitation
Protect from moisture
Fragile
Keep upright
Humidity limitation
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