Nellcor Oximax NPB-40 Operator's Manual

Nellcor Oximax NPB-40 Operator's Manual

Handheld pulse oximeter
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Summary of Contents for Nellcor Oximax NPB-40

  • Page 2 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;...
  • Page 3: Table Of Contents

    Description of the Display and Indicators ....16 Description of Audible Indicators ......... 22 Set up the NPB-40 ..............25 List of Components ............27 Connect OXIMAX Sensor to the NPB-40 ....27 Battery Operation ..............31 Battery Power .............. 31 Low Battery Indicator ........... 31 Critical Battery Indication ..........
  • Page 4 Contents Procedure — Menu Structure ......46 Adjust Alarm Volume ........... 47 Discussion ............47 Procedure ............48 Set Time and Date ............49 Discussion ............49 Procedure ............50 Set Alarm Silence Duration ......... 54 Discussion ............54 Procedure ............54 Disable Audible Alarms ..........
  • Page 5 Contents Performance Considerations ........... 91 Performance Verification ..........91 NPB-40 Performance Considerations ......91 Dysfunctional Hemoglobins ......92 Anemia ............92 Saturation ............93 Pulse Rates ............ 93 OXIMAX Sensor Performance Considerations .... 93 Troubleshooting ............... 99 Error Codes ............... 100 Corrective Action ............
  • Page 6 Printer Alignment .............. 69 Figure 3: Combined Printed Data ............ 71 Figure 4: PD-22T Setup Report ............73 Figure 5: NPB-40 Boot with Clip ............85 Figure 6: NPB-40 Carrying Case ............. 86 Figure 7: Water-Resistant Jacket ............. 87 Figure 8: Printer ................
  • Page 7 T a b l e s Table 1: Flash Rates ................ 18 Table 2: Parameter Ranges ............. 35 Table 3: Nellcor Oximetry Sensor Models and Patient Weights ..80 Table 4: OXIMAX Sensor Features ..........83 Table 5: Error Codes ..............101 Table 6: Menu Structure ..............
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  • Page 9: Safety Information

    (death, injury, or adverse events) to the patient or user. WARNING: The sensor uses the date and time provided by the 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 NPB-40."...
  • Page 10 WARNING: Do not silence the audible alarm function or decrease the audible alarm volume if patient safety could be compromised. WARNING: The NPB-40 is a prescription device to be operated only by trained personnel. WARNING: Dispose of batteries in accordance with...
  • Page 11: 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 O NPB-40 handheld pulse oximeter. Caution: All combinations of equipment must be in compliance with IEC Standard 60601-1-1 systems requirements.
  • Page 12: Notes

    Safety Information Notes Notes are identified by the NOTE symbol shown above. Notes provide additional helpful information.
  • Page 13: Introduction

    How to Use this Manual All users should read this manual thoroughly. More experienced users of the NPB-40 will be able to go 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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  • Page 15: Description Of Controls, Indicators, And Symbols

    I n d i c a t o r s , a n d S y m b o l s Identification of Front Panel Buttons and Symbols area of display 1 — % 2 — Measured % Pulse beats per minute (BPM) area of display 3 — 4 — Measured BPM NPB-40...
  • Page 16 Description of Controls, Indicators, and Symbols 5 — indicator %SpO Lower Alarm Limit 6 — indicator %SpO Upper Alarm Limit 7 — indicator (Blip bar) Pulse Amplitude 8 — time/date field separator Time Colon 9 — mode indicator Adjust Time 10 —...
  • Page 17 Alarm Volume Adjust 20 — indicator Pulse Beep Tone Volume Adjust 21 — indicator BPM Lower Alarm Limit 22 — indicator Print 23 — indicator Motion 24 — indicator Pulse Search 25 — indicator Data 26 — indicator Alarm Silenced NPB-40...
  • Page 18 Description of Controls, Indicators, and Symbols 27 — button Power 28 — button Up Arrow 29 — button Backlight 30 — button Menu 31 — (Record/Print) button Data 32 — button Down Arrow 33 — button Alarm Silence...
  • Page 19: Npb-40 Symbols

    Description of Controls, Indicators, and Symbols NPB-40 Symbols These symbols are located on the rear panel of the NPB-40. 1 — Label 2 — Battery Cover See Instructions for Use Type BF Applied Part - Not defibrillator proof Resistant to liquid ingress...
  • Page 20 Canadian/USA certification mark (electrical safety) Russian regulatory approval Serial number These two symbols are located on the front panel of the NPB-40. Area of the display that displays the measured percent of oxygen saturation. Area of the display that displays the measured pulse beats...
  • Page 21: Description Of Controls

    Description of Controls, Indicators, and Symbols These symbols are also used on the NPB-40 labels. Keep away from heat Temperature limitation Protect from moisture Fragile Keep upright Description of Controls NPB-40...
  • Page 22 Description of Controls, Indicators, and Symbols Note: When the NPB-40 is turned on, a button press, except the Power button, should result in either a valid or an invalid key tone (refer to Description of Audible Indicators on page 22). If the key pressed fails to emit a tone, contact qualified service personnel.
  • Page 23 Settable parameters include high and low SpO limits, high and low BPM limits, alarm volume, pulse beep volume, and data print. The NPB-40 will return to normal operation and incorporate the selected parameter value if there are no button presses for 27 to 33 seconds. See Menu Structure on page 113.
  • Page 24: Description Of The Display And Indicators

    Press the Up Arrow button during normal operation to increase the pulse beep volume. The Power button. Press the Power button to toggle the NPB-40 power ON or OFF. The Power button has a raised protrusion (bump) at its center and a gloss surface finish for tactile differentiation.
  • Page 25 These individual matrices or combinations of these matrices are used to drive the icon indicators on the NPB-40 front panel. The O algorithm automatically extends the amount of data required for measurements of SpO and pulse rate dependent on the measurement conditions.
  • Page 26: Table 1: Flash Rates

    Description of Controls, Indicators, and Symbols Selected display elements (icons, numerals, etc.), may flash. There are three flash rates. See Table 1. Table 1: Flash Rates Priority Hertz Duty Cycle High 1.4 Hz to 2.8 Hz 20% to 60% Medium 0.4 Hz to 0.8 Hz 20% to 60% Constant on...
  • Page 27 15 or fewer minutes of battery capacity remain. The Low Battery indicator displays constantly when the battery capacity reaches critical condition, the NPB-40 indicates an error condition and shuts down. Alarm Silenced indicator. The Alarm Silenced indicator displays when audible alarms have been silenced.
  • Page 28 SpO or Pulse Rate. Data indicator. The Data indicator displays when the NPB-40 is in the store snap-shot data or data print mode. The Data indicator flashes when snap-shot data prints. Print indicator. The Print indicator displays to indicate that the NPB-40 is in the print mode.
  • Page 29 Pulse Beep Tone Volume Adjust indicator. The Pulse Beep Tone Volume Adjust indicator displays when the NPB-40 is in the pulse beep tone volume adjust mode. Adjust Time indicator. The Adjust Time indicator displays when the NPB-40 is in the time/date set mode.
  • Page 30: Description Of Audible Indicators

    Description of Audible Indicators The NPB-40 generates auditory signals for use as alarms, status indicators, and feedback. A summary of the audible indicators is provided below. See Audible Indicators on page 127 for a more detailed definition of the audible indicators.
  • Page 31 1,200 Hz, 250 msec each at 52 dB(A) maximum • Medium priority alarm tone — continuous pulses at 752 Hz, 400 msec each at 52 dB(A) maximum • Low priority alarm tone — continuous pulses at 500 Hz, 250 msec each at 52 dB(A) maximum NPB-40...
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  • Page 33 S e t u p t h e N P B - 4 0 WARNING: To ensure patient safety, do not place the NPB-40 in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
  • Page 34: Set Up The Npb-40

    WARNING: Do not use an NPB-40, O sensor, or cables that appear damaged. WARNING: Do not lift the NPB-40 by the sensor or extension cable because the cable could disconnect from the NPB-40 and the NPB-40 may drop on the patient.
  • Page 35: List Of Components

    Set up the NPB-40 WARNING: The NPB-40 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NPB-40 should be observed to verify normal operation using the configuration in which it is to be used.
  • Page 36 Set up the NPB-40 Caution: Use only Nellcor-approved O sensors and extension cables. Note: Physiological conditions, medical procedures, or external agents that may interfere with the NPB-40’s ability to detect and display measurements include: • dysfunctional hemoglobin • arterial dyes •...
  • Page 37 Connect a Nellcor O sensor to the NPB-40 sensor port. Note: An extension cable may be used to provide more distance between the NPB-40 and the sensor. Use the DEC-4 extension cable available from Nellcor: • DEC-4, 4 feet (1.2 m)
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  • Page 39: Battery Operation

    Battery Power The NPB-40 has internal batteries used to power the NPB-40. A new set of batteries will provide at least 15 hours of operation. Low Battery Indicator The Low Battery indicator displays and flashes, and a low priority alarm begins to sound when approximately 15 minutes of operation is available.
  • Page 40: Critical Battery Indication

    Battery Operation Caution: If the NPB-40 is to be stored for a period of three months or longer, remove the batteries from the NPB-40 before storage. Critical Battery Indication When the NPB-40 batteries are critically low, the NPB-40: • displays an error message (Er 521) •...
  • Page 41: Battery Installation

    Battery Operation Battery Installation 1. Turn off power. Pull the battery compartment latch downward, toward the bottom of the NPB-40, and remove the battery access door. 2. Install four “AA” size batteries, orientated as shown in Figure 1. 3. Replace the battery access door.
  • Page 42 NPB-40 in the presence of flammable anesthetics mixed with air, oxygen, or nitrous oxide. WARNING: To ensure patient safety, do not place the NPB-40 in any position that might cause it to fall on the patient. WARNING: As with all medical equipment, carefully route patient cables to reduce the possibility of patient entanglement or strangulation.
  • Page 43: N P B - 4 0 O P E R A T I O N

    N P B - 4 0 O p e r a t i o n Introduction The parameters of the NPB-40 are preset to factory default values. See Table 2. Table 2 lists the parameters, ranges available, and the factory default values. The parameters may be set on an individual basis, by the clinician, and will remain in effect until the NPB-40 is turned off.
  • Page 44: Turn On The Npb-40

    You must verify that the NPB-40 works properly and is safe to use. Proper operation of the NPB-40 is verified each time the NPB-40 is turned on, as described in this procedure. The verification procedure Power-On Self-Test (POST) takes 7 to 13 seconds to complete.
  • Page 45 Caution: During POST (immediately after power-up), confirm that all display segments and icons are shown, and the NPB-40 speaker sounds a one-second tone. When the NPB-40 is turned on, the backlight remains on, the display cycles through the following sequence as POST takes place: •...
  • Page 46: Procedure

    NPB-40 Operation Procedure 1. Press the Power button to turn on the NPB-40. Note: The backlight will remain on throughout POST. 2. All display numbers and icons are shown for three seconds. The backlight is turned on while all numbers and icons are shown.
  • Page 47 %SpO area of the display. The software version number is shown with foremost zeros for software version numbers less than 100. Note: The software version shown above is only a sample. Check the NPB-40 for the software version installed. NPB-40...
  • Page 48 NPB-40 Operation Note: Software version numbers are often needed when calls are made to Nellcor’s Technical Services Department or your local Nellcor representative for technical assistance. Write down the software version number and have it available prior to requests for technical assistance.
  • Page 49 NPB-40 Operation 6. If the NPB-40 detects a problem, an error tone sounds and the NPB-40 displays an error code (Er) and the error number (see Troubleshooting on page 99). 7. Upon successful completion of POST, the NPB-40 sounds a one-second tone to indicate that the NPB-40 has passed the test.
  • Page 50: Oximax Sensor Attached

    NPB-40, the Data In-Sensor indicator is shown. The NPB-40 displays two dashes in the %SpO and Pulse Rate displays as the NPB-40 searches for a valid pulse. For optimal performance, allow the NPB-40 to search and lock onto a pulse for approximately 10 seconds in non-motion conditions.
  • Page 51 NPB-40 Operation When an O sensor is attached to the NPB-40 and is applied to a patient, and the loses the pulse NPB-40 signal, the will display “-- & --” (two dashes and NPB-40 two dashes) and display the Pulse Search icon for five seconds before the Sensor Disconnected icon is displayed.
  • Page 52: No Oximax Sensor Attached

    NPB-40 Operation No O Sensor Attached Upon successful completion of POST, the NPB-40 sounds a one-second tone that indicates that the NPB-40 has passed POST. displays dashes (--) and the Pulse Search NPB-40 indicator is not displayed when the fails to detect...
  • Page 53: Adjust Pulse Beep Volume

    The default pulse beep volume is 52 dB(A) shown by 10 blip bar segments. Note: When the NPB-40 times-out (30 seconds) the currently shown parameter is set and the NPB-40 display returns to the normal mode. NPB-40...
  • Page 54: Procedure - Normal Operation

    Procedure — Menu Structure With the NPB-40 in the normal mode: 1. Press the Menu button five times until the pulse beep volume level is shown and sounds on the...
  • Page 55: Adjust Alarm Volume

    The default alarm volume is at least 52 dB(A) shown by 10 blip bar segments. Note: When the NPB-40 times-out (30 seconds) the currently shown parameter is set and the NPB-40 display returns to the normal mode.
  • Page 56: Procedure

    NPB-40 Operation Procedure With the NPB-40 in the normal mode: 1. Press the Menu button six times. 2. Press the Up Arrow or Down Arrow button to increase or decrease alarm volume. 3. Press the Menu button two times to set the alarm...
  • Page 57: Set Time And Date

    When the year entry is made, the NPB-40 checks the day and month selections to see if they are correct. If the day or month selection is not valid for the year selected the menu display returns to the day selection display.
  • Page 58: Procedure

    1. Press the Power button to turn the NPB-40 off. 2. Press the Power button to turn the NPB-40 on. 3. Press the Menu button, while the NPB-40 is in the POST mode, until the set hours display is shown.
  • Page 59 NPB-40 Operation 5. Press the Menu button to set the hours and display the minutes set display. The minutes display (45) will flash. 6. Press the Up Arrow button or the Down Arrow button until the desired minutes are shown.
  • Page 60 NPB-40 Operation 7. Press the Menu button to set the minutes and display the day set display. The day (29) will flash. 8. Press the Up Arrow button or the Down Arrow button until the desired day is shown. 9. Press the Menu button to set the day and display the...
  • Page 61 NPB-40 Operation 10. Press the Up Arrow button or the Down Arrow button until the desired month is shown. 11. Press the Menu button to set the month and display the year set display. The year (2004) will flash. 12. Press the Up Arrow button or the Down Arrow button until the desired year is shown.
  • Page 62: Set Alarm Silence Duration

    A low battery low-priority alarm cannot be silenced. Note: When the NPB-40 times-out (30 seconds), the currently shown parameter is set and the NPB-40 returns to the normal mode.
  • Page 63 NPB-40 Operation 1. Press the Alarm Silence button until SEC or OFF is displayed on the pulse rate area of the display, then release the button. Alarm silence durations that are available are OFF, 30, 60, 90, and 120 seconds.
  • Page 64: Disable Audible Alarms

    Disable Audible Alarms Discussion When the alarm silence duration is set to OFF the NPB-40 will produce no audible alarms. The Alarm Silence indicator will flash while the alarm silence duration is set to off. WARNING: Do not silence the audible alarm function or decrease the audible alarm volume if patient safety could be compromised.
  • Page 65 NPB-40 Operation 1. Press the Alarm Silence button until SEC or OFF is displayed in the pulse rate area of the display, then release the button. Alarm silence durations that are available are OFF, 30, 60, 90, and 120 seconds.
  • Page 66 NPB-40 Operation 2. Press the Up Arrow button or the Down Arrow button until OFF is shown. 3. Press the Alarm Silence button to set the alarm silence duration to OFF and return to normal operation. Note: The Alarm Silenced indicator will flash and an audible reminder sounds every three minutes while the alarm silence duration is set to OFF.
  • Page 67: Set Alarm Limits

    See Alarm Limit Changed Indicator on page 63. Note: When the NPB-40 times-out (30 seconds), the currently shown parameter is set and the NPB-40 display returns to the normal mode.
  • Page 68 NPB-40 Operation Note: The %SpO low alarm limit range is 20% to 99%. The upper value of the %SpO low alarm limit is limited to the %SpO upper alarm limit. The %SpO low alarm limit cannot be set equal to or higher than the %SpO upper alarm limit.
  • Page 69 NPB-40 Operation Note: The %SpO upper alarm limit range is 21% to 100%. The lower value of the %SpO upper alarm limit is limited to the %SpO low alarm limit. The %SpO upper alarm limit cannot be set equal to or lower than the %SpO low alarm limit.
  • Page 70 NPB-40 Operation 6. Press the Up Arrow or Down Arrow buttons to increase or decrease the shown limit parameter. 7. Press the Menu button to set the limit value. The BPM upper alarm limit is shown. Note: The pulse rate upper alarm limit range is 31 to 250.
  • Page 71: Alarm Limit Changed Indicator

    10. Press the Menu button four times to return to normal operation. Note: Limit changes will only be in effect as long as the NPB-40 remains turned on. When the NPB-40 turned off, the default limits will be restored in the .
  • Page 72: Record Snap-Shot Data

    Events are retained in the NPB-40 memory while the NPB-40 remains on and cleared when the NPB-40 is turned off or powers itself off. If the events are cleared the events will not be available to print.
  • Page 73: Procedure

    NPB-40 Operation Procedure With the NPB-40 in the normal mode: 1. Press the Data button to capture a snap-shot of the NPB-40 data. The capture data display will be shown. Note: The number (1) in the SpO field is the identification (ID) number of captured snap-shots.
  • Page 74: Print Data

    NPB-40 Operation 2. The NPB-40 returns to the normal mode after about three seconds. Print Data The NPB-40 can print data when used with a Citizen printer, model PD-22T, which is available from Nellcor Customer Services 1.800.635.5267 or your local Nellcor representative.
  • Page 75: Printing Data

    The Print-mode indicator (page icon) flashes at the medium rate throughout the print mode. When the print function is complete, the display returns to the normal mode. When NPB-40 times-out before the Data button is pressed, the display returns to the normal mode.
  • Page 76: Procedure

    NPB-40 is powered on, and any sensor trend data. If snap-shot data are stored in the NPB-40 memory, the Data icon is displayed on the print data display. If sensor-event data are stored in sensor memory, the Data In-Sensor icon is displayed on the print data display.
  • Page 77: Figure 2: Printer Alignment

    NPB-40 Operation 1. Align the printer and the NPB-40. Place the printer and the NPB-40 on a flat, stable surface. 2. Orientate the printer and NPB-40 as shown in Figure 2. The alignment of the infrared ports of the printer and the NPB-40 must not exceed two feet (61 cm) separation and be within 15 degrees of centerline of each window.
  • Page 78 NPB-40 Operation 3. Press the Menu button seven times. The print display is shown. 4. Press the Data button to start printing. During printing, the stored snap-shot number is display for each snap-shot.
  • Page 79: Figure 3: Combined Printed Data

    NPB-40 Operation The NPB-40 prints all available data. Figure 3 illustrates all the print information that may be available. Figure 3: Combined Printed Data NPB-40...
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  • Page 81: Printer Setup Report

    NPB-40 Operation Printer Setup Report The printer is shipped with a PD-22 Setup Report. See Figure 4 for a copy of the printer setup report. The setup report lists the preset condition of the PD-22T printer. Figure 4: PD-22T Setup Report...
  • Page 82 NPB-40 Operation...
  • Page 83: Oximax Sensor Event Record

    S e n s o r E v e n t R e c o r d Event Records WARNING: The sensor uses the date and time provided by the 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 NPB-40.
  • Page 84 (event records) has been connected to an O monitor capable of displaying sensor event records. The NPB-40 does not support viewing sensor event records, but does support printing sensor event records. Event records are designed to view...
  • Page 85: Oximax Sensor Event Record Data

    A c c e s s o r i e s WARNING: The sensor uses the date and time provided by the 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 NPB-40.
  • Page 86: Oximax Sensors And Accessories

    Do not use an O sensor with exposed optical components. WARNING: Use only Nellcor-approved O sensors and extension cables with the NPB-40. Other sensors or extension cables may cause improper NPB-40 performance. WARNING: Do not attach any cable to the O sensor port connector that is intended for computer use.
  • Page 87 WARNING: Do not immerse or wet the O sensor. WARNING: Do not lift the NPB-40 by the sensor or extension cable because the cable could disconnect from the NPB-40, causing the NPB-40 to drop on the patient.
  • Page 88: Table 3: Nellcor Oximetry Sensor Models And Patient Weights

    For a complete and up-to-date listing of all O sensors applicable to the NPB-40, refer to the latest Sensor Accuracy Grid posted on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html When selecting an O sensor, consider the patient’s...
  • Page 89 OXIMAX Sensors and Accessories Table 3: Nellcor Oximetry Sensor Models and Patient Weights (Continued) Patient Size Sensor Model > = greater than < = less than Softcare SC-A >40 kg (88 lbs) nonadhesive sensor, single- patient-use, adult adhesive sensor, MAX-A >30 kg (66 lbs)
  • Page 90 OXIMAX Sensors and Accessories Table 3: Nellcor Oximetry Sensor Models and Patient Weights (Continued) Patient Size Sensor Model > = greater than < = less than OxiCliq OxiCliq I 3 to 20 kg nonadhesive sensor, (6.6 to 44 lbs) single...
  • Page 91: Oximax Sensor Features

    Rev. B Sensor Event Record Sensor Messages Sensor ID Message Biocompatibility Test Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing. The O sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993-1.
  • Page 92: Optional Accessories

    OXIMAX Sensors and Accessories Optional Accessories The optional accessories offered with the NPB-40 are: • protective boot with clip, page 85 • carrying case, page 86 • water-resistant jacket, page 87 • printer, page 87 • thermal paper, page 88 •...
  • Page 93: Boot With Clip

    OXIMAX Sensors and Accessories Boot With Clip This accessory protects the NPB-40. 1 — Front view 2 — Rear view Figure 5: NPB-40 Boot with Clip NPB-40...
  • Page 94: Carrying Case

    OXIMAX Sensors and Accessories Carrying Case The Nylon carrying case is equipped with compartments for the NPB-40, Operator’s manual, compact disk containing all manuals, and sensors. The case comes with a carrying strap that is adjustable from 71 cm to 135 cm (28 inches to 53 inches).
  • Page 95: Water-Resistant Jacket

    OXIMAX Sensors and Accessories Water-Resistant Jacket The water-resistant jacket is made of clear plastic to facilitate use of the NPB-40. Figure 7: Water-Resistant Jacket Infrared Printer Figure 8: Printer NPB-40...
  • Page 96: Thermal Paper

    OXIMAX Sensors and Accessories The Citizen's PD-22T portable printer is used to print selected data from the NPB-40. The NPB-40 uses the printer IrDA infrared interface. Refer to the User’s Manual supplied with the printer for details on the PD-22T printer.
  • Page 97: Dec-4 Extension Cable

    OXIMAX Sensors and Accessories DEC-4 extension cable 1 — DEC-4 extension cable 2 — Sensor connector Figure 10: DEC-4 Extension Cable The DEC-4 extension cable provides 1.2 m (4 ft.) of cable extension between the NPB-40 and the sensor. NPB-40...
  • Page 98 OXIMAX Sensors and Accessories Blank Page...
  • Page 99: Performance Considerations

    Performance Verification section of the NPB-40 service manual. Qualified service personnel should perform these procedures before using the NPB-40 for the first time in a clinical setting. NPB-40 Performance Considerations Certain patient conditions can affect the measurements of the NPB-40 and cause the loss of the pulse signal.
  • Page 100: Dysfunctional Hemoglobins

    Performance Considerations Inaccurate measurements can be caused by: • prolonged and/or excessive patient movement • venous pulsations • intravascular dyes, such as indocyanine green or methylene blue • externally applied coloring agents (nail polish, dye, pigmented cream) • defibrillation Dysfunctional Hemoglobins Dysfunctional hemoglobins, such as carboxyhemoglobin, methemoglobin, and sulphemoglobin, are unable to carry oxygen.
  • Page 101: Saturation

    The NPB-40 will display saturation levels between 1% and 100%. Pulse Rates The NPB-40 displays pulse rates between 20 and 300 beats per minute. The sensor accuracy ranges do not apply to pulse rates above 250 bpm. Detected pulse rates below 20 are shown as 0.
  • Page 102 Performance Considerations Inaccurate measurements can be caused by: • incorrect application of the O sensor • placement of the O sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line • ambient light • prolonged and/or excessive patient movement •...
  • Page 103 MAX-R O sensor or the MAX-FAST O sensor. The MAX-R O sensor obtains measurements from the nasal septal anterior ethmoid artery, an artery supplied by the internal carotid. These sensors may obtain measurements when peripheral perfusion is relatively poor. NPB-40...
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  • Page 105 Performance Considerations NPB-40...
  • Page 106 Performance Considerations...
  • Page 107: Troubleshooting

    T r o u b l e s h o o t i n g WARNING: If you are uncertain about the accuracy of any measurement, check the patient's vital signs by alternate means; then make sure the NPB-40 is functioning correctly. WARNING: The cover should only be removed by qualified service personnel.
  • Page 108: Error Codes

    Note: The error code number may contain up to three digits. When an error code (other than the ones listed in Table 5) is shown, turn the NPB-40 off, wait 10 seconds, and turn the NPB-40 on. If the error code reappears, record it and notify service personnel.
  • Page 109: Table 5: Error Codes

    “Er XXX,” and sound a low priority alarm. Turn the NPB-40 off, wait 10 seconds, then turn the NPB-40 on. If the error appears, follow the action(s) listed in Table 5. Table 5: Error Codes...
  • Page 110: Corrective Action

    2 — Notify service personnel. Set the NPB-40 time and date. Corrective Action If you experience a problem while using the NPB-40 and are unable to correct it, contact qualified service personnel or your local Nellcor representative. The NPB-40 service manual, which is for use by qualified service personnel, provides additional troubleshooting information.
  • Page 111 Test the sensor on another subject. Try another sensor or extension cable. • Perfusion may be too low for the NPB-40 to track the pulse. Check the patient. Test the NPB-40 on yourself. Change the sensor site. Try another sensor.
  • Page 112 • Check the patient. • Perfusion may be too low for the NPB-40 to track the pulse. Test the NPB-40 on another subject. Change the sensor site. Try another type of sensor. • Excessive patient motion may be preventing the NPB-40 from tracking the pulse.
  • Page 113: Emi (Electro-Magnetic Interference)

    5. Er followed by a number appears on the display. • Disconnect the sensor from the NPB-40. Restart the NPB-40. If error code appears again, record the number and provide that information to qualified service personnel or your local Nellcor representative.
  • Page 114: Obtaining Technical Assistance

    Troubleshooting The NPB-40 is designed for use in environments in which the pulse can be obscured by electromagnetic interference. During such interference, measurements may seem inappropriate or the may not seem to NPB-40 operate correctly. Disruption may be evidenced by erratic readings, cessation of operation, or other incorrect functioning.
  • Page 115 NPB-40 time the successfully completes the power-on NPB-40 self-test. Write the number down and have it available whenever requesting technical assistance. The current copy of this manual and the NPB-40 service manual are available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/ProductManuals.html NPB-40...
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  • Page 117: Maintenance

    Caution: The institution should follow local government regulations and recycling instructions regarding disposal or recycling of the batteries and NPB-40 components or end of life of the NPB-40. Caution: The NPB-40 will not operate with dead batteries. Install new batteries.
  • Page 118: Service

    Inspect the safety relevant labels for legibility. Cleaning Caution: Do not spray, pour, or spill any liquid on the NPB-40, its accessories, connectors, switches, or openings in the chassis. For surface-cleaning and disinfecting the NPB-40, follow the institution's procedures or:...
  • Page 119 70% alcohol in water, and lightly wiping the surfaces of the NPB-40 • The NPB-40 may be disinfected using a soft cloth saturated with a solution of 10% chlorine bleach in tap water. Before attempting to clean an SpO...
  • Page 120 Blank Page...
  • Page 121: Menu Structure

    Self-Test (POST) test to access the Time/Date setting menu. Repeated activations of the Menu button in this menu sequence displays five (5) time/date parameter- setting displays that allows the user to set Hour, Minute, Day, Month, and Year, and then return to the POST display. Structure NPB-40...
  • Page 122: Table 6: Menu Structure

    Menu Structure Table 6: Menu Structure # of Parameter Press Function Presses %SpO Adjust limit Limit %SpO Adjust limit High Limit BPM Low Adjust limit Limit BPM High Adjust limit Limit Pulse Beep Adjust volume. Indications Volume on blip bar. Alarm Adjust volume.
  • Page 123: Table 7: Time Set Menu

    Print summary and/or stored snap-shot and sensor-event data. Table 7: Time Set Menu # of Parameter Press Function Presses must be pressed during the NPB-40 POST. Hour Adjust 1 to 23 Minute Adjust 1 to 59 Adjust 1 to 31 NPB-40...
  • Page 124 When the year entry is made, the NPB-40 checks the day and month selections to see if they are correct. If the day or month selection is not valid for the year selected the menu display returns to the day selection display.
  • Page 125 Menu Structure • 31 November • 29 February on a non-leap year NPB-40...
  • Page 126 Blank Page...
  • Page 127: Principles Of Operation

    P r i n c i p l e s o f O p e r a t i o n Oximetry Overview The NPB-40 uses pulse oximetry to measure functional oxygen saturation in the blood. Pulse oximetry works by...
  • Page 128: Automatic Calibration

    LEDs varies, an oximeter must know the mean wavelength of the O sensor's red LED to accurately measure During monitoring, the NPB-40's software selects coefficients that are appropriate for the wavelength of that individual O sensor's red LED; these...
  • Page 129: Functional Versus Fractional Saturation

    PO and pH, temperature, the partial pressure of carbon dioxide (PCO ), 2,3-DPG, and fetal hemoglobin. See Figure Figure 11:. NPB-40...
  • Page 130: Oximax Technology

    Principles of Operation Figure 11: Oxyhemoglobin Dissociation Curve Technology The NPB-40 is designed to use Nellcor O brand sensors, which integrate the O technology. These sensors can be identified by their deep lavender/ blue plug color. All O sensors contain a memory...
  • Page 131 The O sensor model number disappears after 5 seconds. Pulse oximeters containing O technology, including the NPB-40, use calibration data contained in the O sensor in calculating the patient’s SpO Consult the O...
  • Page 132 Blank Page...
  • Page 133: Specifications

    70 to 100% ±2 digits Low Perfusion Saturation accuracy will vary by sensor type. Refer to the Sensor Accuracy Grid. The Sensor Accuracy Grid is shipped with the NPB-40. The latest version of the Sensor Accuracy Grid is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/...
  • Page 134 20 to 250 bpm ±3 digits Low Perfusion Saturation accuracy will vary by sensor type. Refer to the Sensor Accuracy Grid. The Sensor Accuracy Grid is shipped with the NPB-40. The latest version of the Sensor Accuracy Grid is available on the Internet at: http://www.mallinckrodt.com/respiratory/resp/Serv_Supp/...
  • Page 135 Volume level Adjustable, 42 to 52 setting dB(A), at one meter Pitch (±30 Hz) 1500 Hz On pulse width 500 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.) Priority NPB-40...
  • Page 136 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator POST Pass Volume level Fixed at 45 dB(A), at one meter Pitch (±30 Hz) 600 Hz On pulse width 1000 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 137 Valid Key Press Volume level Fixed at 45 dB(A), at one meter Pitch (±30 Hz) 800 Hz On pulse width 10 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.) Priority NPB-40...
  • Page 138 Specifications Audible Indicators (Continued) Audible Parameter Value Indicator Pulse Beep Volume level Adjustable, 42 to 52 dB(A), at one meter Pitch (±30 Hz) 1500 Hz On pulse width 50 msec (±20 msec) Off Interval (±20 msec) 10 msec Number of pulses in burst Repetition Pause (±2 sec.)
  • Page 139 Adjustable, 42 to 52 Alarm dB(A), at one meter Pitch (±30 Hz) 752 Hz On pulse width 400 msec (±20 msec) Off Interval (±20 msec) 300 msec Number of pulses in burst Repetition Pause 0 sec. (±2 sec.) Priority NPB-40...
  • Page 140: Electrical

    Specifications Audible Indicators (Continued) Audible Parameter Value Indicator Low priority Volume level Adjustable, 42 to 52 Alarm dB(A), at one meter Pitch (±30 Hz) 500 Hz On pulse width 400 msec (±20 msec) Off Interval (±20 msec) 3200 msec Number of pulses in burst Repetition Pause 0 sec.
  • Page 141 52.5 mW ® OxiCliq OxiCliq N 52.5 mW OxiCliq I 52.5 mW OxiCliq A 52.5 mW 52.5 mW ® Dura-Y D-YS MAX-FAST 52.5 mW Softcare SC-PR 52.5 mW Softcare SC-NEO 52.5 mW Softcare SC-A 52.5 mW Oxiband OXI-A/N 52.5 mW NPB-40...
  • Page 142: Environmental Conditions

    Specifications Environmental Conditions Operation 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...
  • Page 143: Physical Characteristics

    Year of manufacture symbol EN 980 Operation during physical IEC 60068-2-27 at 100 g shock Alarm requirements EN 60601-1-8 Pulse oximeters EN 865 Operation during vibration IEC 60068-2-6 and IEC 60068-2-34 Radiated and conducted EN 55011, Group 1, Class B emissions NPB-40...
  • Page 144: Manufacturer's Declaration

    NPB-40. The NPB-40 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the NPB-40 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF...
  • Page 145: Table 8: Recommended Separation Distances

    Specifications Table 8: Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the NPB-40 (IEC 60601 Frequency of 150 kHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2.5 GHz Equation...
  • Page 146: Table 9: Cable Compliance

    Specifications Table 9: Cable Compliance Cables Comply With: • RF emissions, EN 55011, Class B/Group 1 • EN 60601-1-2: 2001 Maximum Cables and O Sensors Length OxiCliq-OC-3 cable 3 ft. (0.9 m) DEC-4 sensor extension cable 4 ft. (1.2 m) MAX-FAST sensor 30 in.
  • Page 147: Table 10: Electronic Emissions

    Specifications Table 10: Electronic Emissions The NPB-40 is intended for use in the electromagnetic environment specified below. The customer or user of the NPB-40 should assure that it is used in such an environment. Electromagnetic Emission Test Compliance Environment -...
  • Page 148: Table 11: Electromagnetic Immunity

    Specifications Table 11: Electromagnetic Immunity The NPB-40 is intended for use in the electromagnetic environment specified below. The customer or user of the NPB-40 should assure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic...
  • Page 149: Table 12: Electromagnetic Immunity

    Portable and mobile RF communications IEC 61000-4-6 150 kHz to equipment should be 80 MHz used no closer to any part of the NPB-40, Radiated RF 3 V/m 3 Vrms including the cables, than the recommended IEC 61000-4-3 80 MHz to separation distance 2.5 GHz...
  • Page 150 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in which the NPB-40 is used exceeds the applicable RF compliance level above, the NPB-40 should be observed to verify normal operation.
  • Page 151 Specifications NPB-40...
  • Page 152 Specifications...
  • Page 153 83 boot 85 bpm high limit 114 bpm low limit 114 calculated saturation 121 calibration 110 carrying case 86 cautions 3 cleaning 110 connecting an OXIMAX Sensor 27 controls alarm silence 14 backlight 16 data (record/print) 15 NPB-40...
  • Page 154 Index down arrow 14, 16 menu 15 power 16 up arrow 16 dashes 44 date and time 49 day 115 DEC-4 89 DEC-4 extension cable 89 disabling audio alarms 56 disinfecting 110 display %SpO2 18 display update interval 126 dysfunctional hemoglobins 92 electromagnetic interference 105 error codes 100 explosion hazard 1...
  • Page 155: Index

    121 menu structure 113 minute 115 monitor performance considerations 91 monitor displays dashes 44 month 116 motion indicator 19 NPB-40 measurement range 125 returning 109 operating altitude 134 relative humidity 134 temperature 134 optional accessories 84 OXIMAX technology 122...
  • Page 156 Index oximetry overview 119 paper 88 parameter ranges 35 performance considerations pulse oximeter 91 sensor 93 performance verification 91 power-on self-test (POST) 36 print data 115 printer 88 pulse beep volume 114 pulse search indicator 20 recommended separation distances 137 safety checks 110 saturation calculated 121...
  • Page 157 12 temperature limitation 13 type BF applied part 11 technical assistance 106 thermal paper 88 time set menu 115 transport altitude 134 relative humidity 134 temperature 134 troubleshooting 99 help 102 turning on the NPB-40 36 verification NPB-40...
  • Page 158 Index performance 91 warning 1 water resistant jacket 87 wavelength 132 wavelength, sensor 132 year 116...
  • Page 159 Index NPB-40...
  • Page 161 Nellcor Puritan Bennett Division 4280 Hacienda Drive Pleasanton, CA 94588 U.S.A. Telephone Toll Free 1.800.635.5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS, U.K. © 2004 Nellcor Puritan Bennett Inc. All rights reserved Rx ONLY 066989B-0904...

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