Operators Manual
149 Pages
Preview
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Nellcor Puritan Bennett Inc. is an affiliate of Tyco Healthcare. Nellcor, Oxiband, Durasensor, OxiCliq, Dura-Y, MAX-FAST, and OXIMAX are trademarks of Nellcor Puritan Bennett Inc. This ISM device complies with Canadian ICES-001. 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: 4,653,498; 4,802,486; 4,869,254; 4,928,692; 4,934,372; 5,078,136; 5,351,685; 5,485,847; 5,533,507; 5,577,500; 5,803,910; 5,853,364; 5,865,736; 6,083,172; 6,463,310; 6,708,049; and Re.35,122.
Contents Safety Information ... 1 Warnings ... 1 Cautions ... 4 Notes ... 4
Introduction ... 5 Intended Use for the OXIMAX NPB-40 ... 5 How to Use this Manual ... 5
Symbols, Controls, Displays, and Indicators ... 7 Front Panel Description ... 7 Front Panel Symbols ... 11 Rear Panel Symbols ... 12 Label Symbols ... 13 Controls ... 14 Displays and Indicators ... 17 Audible Indicators ... 22
Set up the OXIMAX NPB-40 ... 23 List of Components ... 25 Connect OXIMAX Sensor to the Monitor ... 25 Inaccurate Monitor Measurements ... 26
Battery Operation ... 29 Battery Power ... 29 Low Battery Indicator ... 29 Critical Battery Indication ... 30 Battery Installation ... 31
OXIMAX NPB-40 Operation ... 35 Introduction ... 35 Turn On the OXIMAX NPB-40 ... 36 Discussion ... 36 Procedure ... 37 OXIMAX Sensor Attached ... 41
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No OXIMAX Sensor Attached ... 42 Backlight On/Off ... 43 Adjust Pulse Beep Volume ... 43 Discussion ... 43 Procedure - During Monitoring ... 43 Procedure - Using Menu Structure ... 44 Adjust Alarm Volume ... 45 Discussion ... 45 Procedure ... 46 Set Time and Date ... 47 Discussion ... 47 Procedure ... 48 Set Alarm Silence Duration ... 51 Discussion ... 51 Procedure ... 52 Disable Audible Alarms ... 53 Discussion ... 53 Procedure ... 54 Set Alarm Limits ... 56 Discussion ... 56 Procedure ... 56 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 ii
OXIMAX NPB-40 Operator’s Manual
Water-Resistant Jacket ... 81 Infrared Printer ... 82 Thermal Paper ... 83 DEC-4 Extension Cable ... 84
Performance Considerations ... 85 Performance Verification ... 85 OXIMAX NPB-40 Performance Considerations ... 85 Dysfunctional Hemoglobins ... 86 Anemia ... 86 Saturation ... 86 Pulse Rates ... 86 OXIMAX Sensor Performance Considerations ... 87
Troubleshooting ... 91 Error Codes ... 91 Corrective Action ... 93 EMI (Electro-magnetic Interference) ... 97 Technical Assistance ... 98
Maintenance ... 101 Return the OXIMAX NPB-40 ... 101 Service ... 102 Periodic Safety Checks ... 102 Cleaning ... 103
Menu Structure ... 105 Set Menus Quick Reference ... 105 Set Menu Parameters ... 106 Set Time/Date Parameters ... 108
Principles of Operation ... 111 Oximetry Overview ... 111 Automatic Calibration ... 112 Functional versus Fractional Saturation ... 113 Measured versus Calculated Saturation ... 113 OXIMAX Technology ... 114
Specifications ... 117 Performance ... 117 Electrical ... 124
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Environmental Conditions ... 126 Physical Characteristics ... 126 Compliance ... 127 Manufacturer’s Declaration ... 128
Index ... 135
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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 NPB-40 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 NPB-40.
WARNING: Explosion hazard. Do not use the OXIMAX NPB-40 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 NPB-40 has a broken display panel.
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Safety Information
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 NPB-40.
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 NPB-40 is a prescription device to be operated only by trained personnel. The monitor is for attended monitoring only.
WARNING: Dispose of batteries in accordance with local ordinances and regulations.
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Safety Information
WARNING: The OXIMAX NPB-40 is not defibrillator-proof. However, it may remain attached to the patient throughout defibrillation or while an electrosurgical unit is in use, but the measurements may be inaccurate throughout the defibrillation and shortly thereafter. To avoid shock, the caregiver should not hold the OXIMAX NPB-40 while using a defibrillator on a patient.
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Safety Information
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 NPB-40 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.
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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Introduction
WARNING: Do not make any clinical judgments based solely on the OXIMAX NPB-40. 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 NPB-40 The OXIMAX™ NPB-40 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 NPB-40.
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 - Artifact 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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Symbols, Controls, Displays, and Indicators
Controls This section describes the controls on the front panel of the monitor. The controls are activated by pressing the button that corresponds to that control. For example, press the Alarm Silence button to control the audible alarm. When the monitor is turned on, if you press a button, except the Power button, it results in either a valid or invalid key tone. See Audible Indicators on page 22. If a tone fails to emit when you press a button, contact qualified service personnel. The following monitor display shows the buttons described in this section.
The Alarm Silence button. Silences the audible alarms. If you press the button when no audible alarm is active, alarms during the selected alarm silence duration are silenced. In all cases, the alarm silence times out after the selected alarm silence duration and auditory alarm capability reactivates. Alarms that occur throughout the Power-On Self-Test (POST) cannot be silenced.
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Symbols, Controls, Displays, and Indicators
Press and hold the Alarm Silence button for three seconds to display the Alarm Silence Duration menu, which allows you to adjust the alarm silence interval from 30, 60, 90, or 120 seconds, or to OFF (alarms disabled). See Set Alarm Silence Duration on page 51. The Down Arrow button. Sequentially decreases the parameter under adjustment by one decrement. If you press and hold the button for more than three seconds it may cause the decrement to repeat. Press the Down Arrow button during normal operation to decrease the pulse beep volume. The Data (Record/Print) button. Stores the currently shown SpO2 and BPM values (snap-shot data.) You can print the stored snap-shot data, such as a single-event report, snap-shot, and/or sensor-event data by pressing the Data button in print mode. The Menu button. Press repeatedly during normal operation to display the parameters. Parameters you can set include: •
high and low SpO2 limits
•
high and low BPM limits
•
alarm volume
•
pulse beep volume
•
data print
If you do not press any buttons for approximately 30 seconds, the monitor returns to normal operation and incorporates the selected parameter value. See Menu Structure on page 105 for additional information about setting parameters.
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