Home

Nellcor NPB-40 Handheld Pulse Oximeter User Manual

1. Audibl ue Ble 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 1 burst Repetition Pause N A 2 sec Priority 3 Invalid Key Volume level Fixed at 45 dB A at Press one meter Pitch 30 Hz 200 Hz On pulse width 50 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in 1 burst Repetition Pause N A 2 sec Priority 4 128 Specifications Audible Indicators Continued Audible Parameter Value Indicator Confirmation Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 700 Hz On pulse width 130 msec 20 msec Off Interval 20 msec 130 msec Number of pulses in 3 burst Repetition Pause N A 2 sec Priority 5 Valid Key Press Volume level Fixed at 45 dB A at NPB 40 one meter Pitch 30 Hz 800 Hz On pulse width 10 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in 1 burst Repetition Pause N A 2 sec Priority 6 129 Specifications Audible Indicators Continued Audible Indicator Parameter Value 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
2. Ox Max Sensor Event Record Data NPB 40 The NPB 40 records a patient s OxiMax sensor SpO2 event history from the Ox MAx sensor s memory chip allowing a patient s event history to travel with the patient as the patient moves throughout the hospital This allows caregivers to assess whether the patient had a bad event during transport or in the previous area of care This feature is only available with adhesive single patient use Ox Max sensors Single patient use OxiMax sensors are intended for single patient use only recorded SpO event history data does not distinguish between events that have been collected from multiple patients 77 OXIMAX Sensors and Accessories Select an Ox MAx Sensor 78 gt E EP P WARNING Before use carefully read the OxiMax sensor Directions For Use including all warnings cautions and instructions WARNING Do not use a damaged Ox Max sensor or extension cable Do not use an OxiMax sensor with exposed optical components WARNING Use only Nellcor approved OxIMAx 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 Ox1M4x sensor port connector that is intended for computer use OXIMAX Sensors and Accessories WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO2 Ox1Max sensor Inspect the OxiMx sensor site periodically as dir
3. Figure 2 Printer Alignment NPB 40 69 NPB 40 Operation 3 Press the Menu button seven times The print display is shown SpO2 Q min 2 El 8 0 9 4 Press the Data button to start printing During printing the stored snap shot number is display for each snap shot 70 NPB 40 Operation The NPB 40 prints all available data Figure 3 illustrates all the print information that may be available 14APR 15 22 14 APR 14 59 NELLCOR NPB40 MAX 12 APR 23 15 Version 1 0 0 7 12 APR 17 25 14 APR 15 46 SENSOR EVENT DATA ID DATE TIME DUR 04 05APR 09 01 00 00 30 SPO2 95 98 OSAPR 00 54 00 01 30 SUMMARY DATE TIME DUR 14 APR 15 30 00 01 33 SPO2 96 97 97 BPM 88 96 90 SNAPSHOT DATA 05APR 00 53 00 00 30 ID DATE TIME SPO2 BPM SPO2 96 99 05 14 APR 15 30 84 98 SPO2 95 99 OSAPR 00 54 00 01 00 SPO2 88 89 OUTPUT COMPLETE Figure 3 Combined Printed Data NPB 40 71 Blank Page Printer Setup Report PD 22 SETUP REPORT Baud rate 19200bps Data bit length 8 Stop bit 1 Parity bit None S I Protocol X ON X OFF Print density 0 Paper selection Plain paper Automatic paper feed Disable NPB 40 NPB 40 Operation 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 Eye mark Disable Character code set Italic
4. Loss of pulse signal can occur for the following reasons the Ox Max sensor is applied too tightly a blood pressure cuff is inflated on the same extremity as the one with the OxzMax sensor attached there is arterial occlusion proximal to the OxIMAx sensor poor peripheral perfusion Select an appropriate OxrMAx sensor apply it as directed and observe all warnings and cautions presented in the Directions For Use accompanying the OxzMax sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the OxzMax sensor remains properly positioned on the patient NPB 40 Performance Considerations High ambient light sources such as surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight can interfere with the performance of an SpOz Ox MAx sensor To prevent interference from ambient light ensure that the Ox Max sensor is properly applied and cover the Ox1Max sensor site with opaque material WARNING Failure to cover the OxiMax sensor site with opaque material in high ambient light conditions may result in inaccurate measurements If patient movement presents a problem try one or more of the following remedies to correct the problem e verify that the Ox Max sensor is properly and securely applied e move the Ox MAax sensor to a less active site e use an adhesive Ox M
5. Off Interval 20 msec 10 msec Number of pulses in 1 burst Repetition Pause N A 2 sec Priority 7 Alarm Silence Reminder 130 Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 500 Hz On pulse width 130 msec 20 msec Off Interval 20 msec 130 msec Number of pulses in 3 burst Repetition Pause 179 27 sec 2 sec Priority 8 Specifications Audible Indicators Continued Audible Parameter Value Indicator High Priority Volume level Adjustable 42 to 52 Alarm dB A at one meter Pitch 30 Hz 1200 Hz On pulse width 250 msec 20 msec Off Interval 20 msec 80 msec Number of pulses in 1 burst Repetition Pause 0 sec 2 sec Priority 9 Medium Priority Alarm NPB 40 Volume level Adjustable 42 to 52 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 1 burst Repetition Pause 0 sec 2 sec Priority 10 131 Specifications Audible Indicators Continued Audible Indicator Parameter Value 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 1 bu
6. International charac ter code USA Print pitch 12 cpi Font typeface Roman Code page USA Auto power off 3min Printer status respo nse Disable Offline state at re loading paper Disable Figure 4 PD 22T Setup Report 73 NPB 40 Operation 74 OXIMAX Sensor Event Record Event Records A NPB 40 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 The adhesive Ox Max sensors are capable of storing sensor event data A sensor event data record allows alarm event history to travel with the patient on the sensor s memory chip for quick assessment at every point of care where OxrMAx monitors are used Patient event data is stored on the memory chip of adhesive Ox Max sensors single patient use OxiMax sensors only The sensor event data are stored recorded with the limit threshold settings that were active at the time of the event on the recording monitor These events can be viewed on the next OxiMax sensor monitor when the patient moves to a new point of care An event occurs when the SpO value exceeds either the upper or lower alarm limit for at least 15 seconds The first Ox MAx sensor event record event will be stored in the Ox Max sensor after the OxiM 4x sensor has been attached to a pat
7. NPB 40 Operation 2 Press the Up Arrow button or the Down Arrow button until the desired tone level is heard 3 Press the Menu button three times to set the tone volume and return to normal operation Adjust Alarm Volume Discussion NPB 40 When the Alarm Volume display is shown the user is able to adjust the volume of alarm tones Each activation of an Up Arrow or Down Arrow button increases or decreases the alarm volume and increments or decrements by one the number of segments shown on the Pulse Amplitude blip bar as a relative indicator of the current volume The minimum alarm volume is one one blip bar segment the maximum is ten ten segments Attempted adjustments outside the range generate an invalid key tone 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 47 NPB 40 Operation Procedure With the NPB 40 in the normal mode 1 Press the Menu button six times SpO2 Q min A increase or decrease alarm volume 2 2 Press the Up Arrow or Down Arrow button to 3 Press the Menu button two times to set the alarm level and return to normal mode 48 NPB 40 Operation Set Time and Date Discussion A NPB 40 WARNING The sensor uses the date and time provided by the NPB 40 handheld pulse oximeter wh
8. Press the Menu button to set the alarm limit value operation Note Limit changes will only be in effect as long as the NPB 40 remains turned on When the NPB 40 is turned off the default limits will be restored in the NPB 40 When the NPB 40 is turned on the default limits will be in effect 10 Press the Menu button four times to return to normal Alarm Limit Changed Indicator Alarm limits that have been changed from the default values are identified by a decimal point after the shown value SpO gt or BPM NPB 40 63 NPB 40 Operation The Alarm Limit Changed indicator is displayed anytime an alarm limit is being changed or has been changed SpO2 Q min Record Snap Shot Data Discussion The NPB 40 contains an internal memory that can store 50 patient data event records snap shots Data event records can be printed 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 Replacement of the NPB 40 batteries clears event records The Data indicator flashes at a medium priority rate gt when the NPB 40 patient memory is full 64 NPB 40 Operation Procedure With the NPB 40 in the normal mode NPB 40 data The capture data display will be shown 1 Press the Data button to capture a snap shot of the SpO2 Q min A Note
9. e Press the Up Arrow or Down Arrow button during normal operation to increase or decrese the pulse beep volume e Select pulse beep volume adjust through the menu structure When the pulse beep volume display is shown the user is able to adjust the volume of the pulse beep tone Each activation of an Up Arrow or Down Arrow button increases or decreases the pulse beep volume and increments or decrements by one the number of segments shown on the Pulse Amplitude blip bar as a relative indicator of the current volume The minimum pulse rate volume is none or OFF no blip bar segments shown the maximum pulse rate volume is ten ten segments Attempted adjustments outside the range generate an invalid key tone 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 45 NPB 40 Operation Procedure Normal Operation O Press the Up Arrow or Down Arrow button during normal operation to increase or decrese the pulse beep volume A Note The Beep Tone Volume Adjust indicator flashes when the pulse beep volume is adjusted to Zero 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 NPB 40 SpOz2 Q min 8 0 oe 46 oe
10. 123 Low Battery indicator The Low Battery indicator flashes when 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 It flashes when the audible alarms have been disabled Motion indicator The Motion indicator is displays whenever the Ox7Max algorithm detects the presence of artifacts independent of its severity or the impact on the SpO or pulse rate values When the Motion indicator and the Pulse Search indicator are simultaneously displayed it is an indication that the artifact is significant and or has been persistent Artifacts are events contained within the in sensor data Description of Controls Indicators and Symbols 20 D 3 lt gt H d Pulse Search indicator The Pulse Search indicator displays before initial acquisition of a pulse signal and throughout prolonged and challenged monitored conditions The Pulse Search indicator flashes throughout a loss of pulse signal Data In Sensor indicator The Data In Sensor indicator displays to indicate that the attached Ox MAax sensor contains sensor event data or the in sensor memory is full The Data In Sensor indicator flashes when the sensor contains sensor event data and when sensor event data is
11. 40 Operation Table 2 Parameter Ranges Continued Parameter Ranges Factory Selections Defaults Alarm Silence Alarms 30 60 30 sec Duration 90 120 seconds Alarm Volume 1 to 10 10 Pulse Beep 0 to 10 10 Volume Turn On the NPB 40 Discussion 36 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 Caution If any indicator or display element does not display when the NPB 40 is turned on do not use the NPB 40 Instead contact qualified service personnel your local Nellcor representative or Nellcor s Technical Services Department Note Physiological conditions medical procedures or external agents that may interfere with the NPB 40 s ability to detect and display measurements include e dysfunctional hemoglobin e arterial dyes NPB 40 e e NPB 40 Operation low perfusion dark pigment externally applied coloring agents such as nail polish dye or pigmented cream Note When the NPB 40 is turned on POST automatically tests the NPB 40 circuitry and functions 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 backlig
12. Level Environment Guidance Conducted RF 3 Vrms 3 Vrms 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 calculated from the Recommended Separation Distance d 7 o Die db NPB 40 80 MHz to 800 MHz 800 MHz to 2 5 GHz equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range 141 Specifications Table 12 Electromagnetic Immunity ut Interference may occur in the vicinity of equipment marked with this symbol x Note 1 At 80 MHz the higher frequency range applies a Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strength from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted t
13. 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 5 The current time is shown in a 24 hour format SpOz Q min 40 NPB 40 Operation 6 Ifthe 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 SpO2 Wel V min icJ 5 0 0 0 9 7 Upon successful completion of POST the NPB 40 sounds a one second tone to indicate that the NPB 40 has passed the test WARNING If you do not hear the POST pass tone do not use the NPB 40 WARNING Ensure that the speaker is clear of any obstructions and that the speaker holes are not covered Failure to do so could result in an inaudible alarm tone A Note The POST pass tone also functions as an audible Re confirmation that the speaker performs properly NPB 40 41 NPB 40 Operation Ox Max Sensor Attached 42 Git When a sensor contains data and is attached to the NPB 40 the Data In Sensor indicator is shown The NPB 40 displays two dashes in the SpO2 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 conditi
14. The number 1 in the SpO2 field is the identification ID number of captured snap shots A Note When the Data button is pressed and there is no W empty event memory location available the NPB 40 e displays the last ID number assigned 50 e the Data icon continues to flash at the medium priority rate e sounds an invalid key tone e returns to the normal operating mode immediately NPB 40 65 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 contains a T The T indicates that the printer has Caution Ensure that the printer model number been configured for use with the NPB 40 A Note Read the entire user s manual for the Citizen WK printer model PD 22T prior to operation of the printer with the NPB 40 A Note The NPB 40 must be IR linked to a compatible printer in order to print When the print data display is shown press the Data button to start printing The report always contains a header and footer and one or more of the following summary report if currently connected to a patient e snap shot report if any are stored e sensor data if a sensor with patient event data is connected to the NPB 40 If the Data button is pressed in the print menu when no dat
15. and Symbols NPB 40 Alarm silence reminder tone three pulses at 500 Hz for 130 msec each at 52 dB A maximum High priority alarm tone continuous pulses at 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 23 Blank Page Set up A gt gt gt gt NPB 40 the NPB 40 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 WARNING Ensure that the speaker is clear of any obstruction and that the speaker holes are not covered Failure to do so could result in an inaudible alarm tone WARNING Disconnect the NPB 40 and Nellcor Ox Max 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 NPB 40 to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure 25 Set up the NPB 40 26 gt EPP WARNING Do not use an NPB 40 Ox7M x sensor or cables that appear damaged WARNING Do not lift the NPB 40 by the
16. by a number appears on the display e 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 EMI Electro magnetic Interference NPB 40 Caution This device has been tested and found to comply with the limits for medical devices to the EN60601 1 2 second edition and the Medical Device Directive 93 42 EEC These limits are designed to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of radio frequency transmitting equipment and other sources of electrical noise in health care environments for example electrosurgical units cellular phones mobile two way radios electrical appliances and high definition television it is possible that high levels of such interference due to close proximity or strength of a source may result in disruption of performance of this device 105 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 NPB 40 may not seem to operate correctly Disruption may be evidenced by erratic readings cessation of operation or other incorrect functioning If this occurs the site of use should be surveyed to determine the so
17. is shown 60 NPB 40 Operation A Note The SpO2 upper alarm limit range is 21 to 100 The lower value of the SpO2 upper alarm limit is limited to the SpO2 low alarm limit The SpO2 upper alarm limit cannot be set equal to or lower than the SpO2 low alarm limit SpO2 CH LV min 4 Press the Up Arrow or Down Arrow buttons to increase or decrease the shown limit parameter Note The pulse rate low alarm limit range is 30 to 249 The upper value ofthe pulse rate low alarm limit is limited one number lower than the pulse rate upper alarm limit The pulse rate low alarm limit cannot be set equal to or higher than the pulse rate upper alarm limit 5 Press the Menu button to set the limit value The BPM lower alarm limit is shown NPB 40 61 NPB 40 Operation SpO2 Q min 40 6 8 0 6 Press the Up Arrow or Down Arrow buttons to increase or decrease the shown limit parameter 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 The lower value ofthe pulse rate upper alarm limit is limited to one number above the pulse rate low alarm limit The pulse rate upper alarm limit cannot be set equal to or lower than the pulse rate low alarm limit 0 00 62 NPB 40 Operation SpOz Q min 8 Press the Up Arrow or Down Arrow buttons to increase or decrease the shown limit parameter 9
18. 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 SpO2 Wel Vi min XXX SEC 5 0 0 0 Press the Up Arrow button or the Down Arrow button until the desired alarm silence duration is shown Press the Alarm Silence button to set the shown alarm silence duration and return to normal operation 55 NPB 40 Operation Disable Audible Alarms Discussion A 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 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 Procedure 56 With the NPB 40 in the normal mode NPB 40 Operation 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 PC 1 Press the Alarm Silence button until SEC or OFF is SpO2 YQ Vi min XXX SEC or NPB 40 57 NPB 40 Operation 2 Press the Up Arrow button or the Down Arrow button until OFF is shown SpO2 Wel LV min UFF ee e 3 Press the Alar
19. report is displayed if the NPB 40 is currently posting saturation and rate It then lists snap shot data stored since the 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 If both types of data are stored both icons are displayed If no data are stored neither icon is shown blank display Note The monitor and sensor does not differentiate between patients therefore use caution when reviewing the report as the list of snap shots may contain data from more than one patient Also ifa single use sensor is used more than once the sensor trend report section can contain data from more than one patient Note The snap shot list is deleted when the NPB 40 is turned on When first connecting a single use sensor look for the DATA in SENSOR icon Procedure 68 With the NPB 40 in the normal mode 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 The printer and the NPB 40 must not be closer than six inches 15 cm See Figure 2
20. selected the menu display returns to the day selection display 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 Some examples of illegal dates are 30 February 31 February 31 April 31 June 31 September 116 Menu Structure e 3 November e 29 February on a non leap year NPB 40 117 Blank Page Principles of Operation Oximetry Overview The NPB 40 uses pulse oximetry to measure functional oxygen saturation in the blood Pulse oximetry works by applying an Ox MAx sensor to a pulsating arteriolar vascular bed such as a finger or toe The Ox MAx sensor contains a dual light source and a photo detector Bone tissue pigmentation and venous vessels normally absorb a constant amount of light over time The arteriolar bed normally pulsates and absorbs variable amounts of light during the pulsations The ratio of light absorbed is translated into a measurement of functional oxygen saturation SpO2 Because a measurement of SpO2 is dependent upon light from the Ox Max sensor excessive ambient light can interfere with this measurement Specific information about ambient conditions OxIMAx sensor application and patient conditions is contained throughout this manual Pulse oximetry is based on two principles that oxyhemoglobin and deoxy
21. sensor or extension cable because the cable could disconnect from the NPB 40 and the NPB 40 may drop on the patient WARNING The 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 WARNING Use only the Nellcor extension cable DEC 4 with the NPB 40 Do not attach any cable that is intended for computer use to the OxiMx sensor port Do not connect any device other than a Nellcor approved OxiM4x sensor to the OxIMAX sensor connector Set up the NPB 40 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 WARNING The NPB 40 should not be used adjacent List of Components Quantity Item 1 NPB 40 OXIMAX handheld pulse oximeter 4 Alkaline AA size 1 5 volt batteries 1 Nellcor OXIMAX sensor or sensor assortment pack 1 Compact disk NPB 40 manuals and or operator s manual applicable to country of sale 1 Quick guide adhesive label Connect Ox Max Sensor to the NPB 40 signals can be affected by certain ambient environmental conditions OxIMAx sensor application errors and certain patient conditions See the appropriate sections of the manual for specific safety inform
22. 100 NPB 40 Troubleshooting Table 5 lists the error codes and corrective actions When an error occurs the unit will stop monitoring remove all information from the display and display message Er XXX and sound a low priority alarm Turn the NPB 40 off wait 10 seconds then turn the NPB 40 on Ifthe error appears follow the action s listed in Table 5 Table 5 Error Codes en Action 10 Check replace sensor extension cable 11 1 Replace batteries 2 Notify service personnel 17 Check replace sensor extension cable 19 Check replace sensor extension cable 273 1 Restart the NPB 40 2 Set the time and date 3 Notify service personnel 274 Return NPB 40 for reprogramming 275 Check replace sensor extension cable 276 Replace with Oximax sensor 277 Check replace sensor extension cable 280 Check replace sensor extension cable 282 Check replace sensor extension cable 521 Replace batteries 522 Replace batteries 101 Troubleshooting Table 5 Error Codes Continued Error Code Action 523 1 Restart the NPB 40 2 Set the time and date 3 Notify service personnel 525 1 Restart the NPB 40 2 Notify service personnel 538 Set time and date 539 1 Restart the NPB 40 2 Notify service personnel 543 Set the NPB 40 time and date Corrective Action If you experience a problem while using t
23. 40 use calibration data contained in the Ox Max sensor in calculating the patient s SpO2 Consult the Ox MAx sensor accuracy grid card included with the pulse oximeter for specific accuracy information for the NPB 40 with different Nellcor OxzMax sensors The NPB 40 uses the information in the Ox Max sensor to tailor troubleshooting messages for the clinician The OxiMax sensor contains coding that tells the pulse oximeter what kind of OxzMax sensor is being used When deciding what messages to display the pulse oximeter takes into account the OxzMax sensor type and recommended patient site for that model 123 Blank Page Specifications Performance Measurement Range SpO2 1 to 100 Pulse Rate 0 20 beats per minute bpm to 300 bpm Perfusion Range 0 03 to 20 Accuracy and Motion Tolerance Saturation Without Motion 70 to 100 2 digits With Motion 70 to 100 3 digits Low Perfusion 70 to 100 2 digits l 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 ProductManuals html 2 Applicability OxIMAx MAX A MAX FAST DS 100A D YSE SC NEO and OxiClig A sensors Specification applies to NPB 40 performance NPB 40 125 Specifications 126 Accuracy an
24. 54 Procedures inen e 54 Disable Audible Alarms 56 N E RE 56 PhOCCOUIG sctissstsiccisiadevnadvalgvarddsvateedvasiteseavsateant 56 Set Alarm Bt LC 59 Discussion 59 Procedure EE 59 Alarm Limit Changed Indicator een 63 Record Snap Shot Data ueenseennnennnnnnn 64 Discussion 64 Proceduren a 65 Print DALAM icsscsesceveddaciauvededesssneandauwaartenssvasdedeedsiateavsdanete 66 Printing Data aaa 67 Discussion 67 Procedure oirirc iein 68 Printer Setup Report nneseneennnnnn 72 OXIMAX Sensor Event Record sssssnsnnnsnnnnnunnnnnnnnennnnnnnnennn nnen 75 Event Records 75 OXIMAX Sensors and Accessories auaun2220000000n0nnnnnnnnnnnnnnn 77 OXIMAX Sensor Event Record Data 77 Select an OXIMAX Sensor c ccseesseceeceeeeeseeseeenees 78 OXIMAX Sensor Features uuunesseesenessnnnnnnnnnnnnnnennnnn 83 Biocompatibility Test 83 Optional Accessories uunnsssssennnnnnnnnnnnnnnnnnnennnnnenn 84 Boot With Clip neenseeennnnnnnnennnnnnnnnnnnn 85 Carrying Case nn 86 Water Resistant Jacket ccccceeeeeeeeeeeees 87 Infrared Printer ccccccscesseeseeseeeeeneeeeeeneas 87 Thermal Paper ccccceeeeseeceeeeseeeeeeeeeneeeees 88 DEC 4 extension Cable 89 Contents Performance Considerations naaa0n00000000nnnnnnnnnnn0 91 Performance Verification ccccccccceesseeeeeeeeneeseeeees 91 NPB 40 Performance Consider
25. 74 m 1 280 ft to 18 288 ft Atmospheric Pressure 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage in shipping container Temperature 20 C to 70 C 4 F to 158 F Altitude Atmospheric Pressure 390 m to 5 574 m 1 280 ft to 18 288 ft 50 kPa to 106 kPa 14 7 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Specifications Physical Characteristics Weight 0 62 Ibs 0 28 kg Dimensions 2 875 in x 6 25 in x 1 375 in 7 3 cm x 15 9 cm x 3 5 cm Compliance Item Equipment classification Compliant With Safety Standards EN 60601 1 1990 Al A2 EN 60601 1 2 2001 UL 60601 1 CAN CSA C22 2 No 601 1 Type of protection Internally powered equipment on battery power Degree of protection Type BF Applied part Mode of operation Continuous Front panel and case labeling IEC 60878 EN 980 ISO 7000 EN 60417 1 EN 60417 2 Button spacing ISO 7250 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 emissions EN 55011 Group 1 Class B NPB 40 135 Specifications Manufacturer s Declaratio
26. Adjust Volume mode indicator The Adjust Volume mode indicator displays when the NPB 40 volume levels are under adjustment Sensor Off Patient indicator The Sensor Off Patient indicator displays when the patient sensor is attached to the NPB 40 but not attached to the patient 21 Description of Controls Indicators and Symbols I I i SNAP SHOT DATA ID indicator The SNAP SHOT I d DATA ID indicator is an alphanumeric display that indicates the number of the current captured snapshots The snapshot number is shown in the SpO area of the display Description of Audible Indicators 22 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 e Alarm volume tone one pulse at 752 Hz for 500 msec at 52 dB A maximum e Beep volume tone one pulse at 1 500 Hz for 500 msec at 52 dB A maximum e POST pass tone one pulse at 600 Hz for 1 000 msec at 45 dB A maximum e Invalid key press tone one pulse at 200 Hz for 50 msec at 45 dB A maximum e Confirmation tone one pulse at 700 Hz for 130 msec at 45 dB A maximum e Walid key press tone one pulse at 800 Hz for 10 msec at 45 dB A maximum e Pulse beep tone one pulse at 1 500 Hz for each heart beat for 50 msec at 52 dB A maximum Description of Controls Indicators
27. 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 Motion indicator 24 Pulse Search indicator 25 Data indicator 26 Alarm Silenced indicator Description of Controls Indicators and Symbols SpOz Q min 33 32 31 30 29 28 27 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 10 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 gt gt Resistant to liquid ingress PX1 SE Date of Manufacture E European union approval oO pare N Gi NPB 40 11 Description of Controls Indicators and Symbols 12 GR Canadian USA certification mark electrical safety c US CG Russian regulatory approval WMOA Serial number SN These two symbols are located on the front panel ofthe NPB 40 SpO2 O min SpOz2 Area of the display that displays the measured percent of oxygen saturation Q min Area of the display that displays the measured pulse beats per minute Description of Con
28. 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 Low N A Constant on SpO2 display Shows the oxygen saturation level of functional hemoglobin Displays two dashes throughout Sensor Disconnected and Sensor Off Patient conditions The display flashes the SpO2 value when the SpO is outside the alarm limits If alarm limits have been changed from their power on defaults a decimal point is shown after the SpO2 value 98 Pulse Amplitude indicator blip bar The Pulse Amplitude indicator indicates the dynamic pulse amplitude and rate As the detected pulse becomes stronger more bars light with each pulse In the parameter set menu the Pulse Amplitude indicator displays with the number of shown elements incremenated decremented to reflect changes in the volume level for alarms and Pulse Amplitude indicator blip bar O min Idi NPB 40 Description of Controls Indicators and Symbols PULSE RATE display Shows the pulse rate in beats per minute It flashes throughout loss of pulse alarms and when the pulse rate is outside of the alarm limits The PULSE RATE display displays two dashes throughout Sensor Disconnected and Sensor Off Patient conditions Pulse rates outside of the pulse rate range 0 20 to 300 bpm are shown as the closest value within the range If alarm limits have been changed from their power on defaults a decimal point is shown after the BPM value
29. Nellcor OxIMax SpO sensor to the NPB 40 SpOz2 sensor port A Note An extension cable may be used to provide more La distance between the NPB 40 and the sensor Use the DEC 4 extension cable available from Nellcor e DEC 4 4 feet 1 2 m NPB 40 29 Blank Page Battery Operation WARNING Dispose of battery in accordance with local ordinances and regulations 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 The batteries should be replaced See Battery Installation on page 33 SpO2 OY min NPB 40 31 Battery Operation three months or longer remove the batteries from the Caution If the NPB 40 is to be stored for a period of NPB 40 before storage Critical Battery Indication When the NPB 40 batteries are critically low the NPB 40 e displays an error message Er 521 e sounds a high priority alarm e shuts down Replace the batteries and restart the NPB 40 See Battery Installation on page 33 SpO2 Q min Se i 0 x 32 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 fo
30. V min button until the desired minutes are shown 2 6 Press the Up Arrow button or the Down Arrow NPB 40 51 NPB 40 Operation 7 Press the Menu button to set the minutes and display the day set display The day 29 will flash SpO2 Wel WV min 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 month set display The month 7 will flash SpO2 Wel V min 52 NPB 40 Operation button until the desired month is shown O 10 Press the Up Arrow button or the Down Arrow 11 Press the Menu button to set the month and display the year set display The year 2004 will flash Oo SpOz2 Q min rg cu Du 8 0 00 A 12 Press the Up Arrow button or the Down Arrow button until the desired year is shown 13 Press the Menu button to set the year and return to normal operation NPB 40 53 NPB 40 Operation Set Alarm Silence Duration Discussion The Alarm Silence Duration display allows the user to adjust the alarm silence duration of the high medium and low priority alarms A low battery low priority alarm cannot be silenced A Note When the NPB 40 times out 30 seconds the currently shown parameter is set and the NPB 40 returns to the normal mode Procedure With the NPB 40 in the normal mode 54 NPB 40 NPB 40 Operation Press the Alarm Silence button until SEC
31. a is stored and the device is not connected to a patient an invalid key tone is sounded and the NPB 40 transitions to the normal mode 66 NPB 40 Operation 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 The Menu button is disabled during the print mode If there is no communication with the printer for 30 seconds the print mode is aborted and the display returns to the normal mode Summary report data is purged after it is printed or on time out due to printer communication failure Printing or time out due to printer communication failure does not purge snap shot or sensor event data this data is purged from the NPB 40 memory at power off Sensor event data is retained in the sensor and loads reloads to the NPB 40 memory at power on Alarm annunciation and patient monitoring is disabled during active printing when the NPB 40 is communicating with printer Printing Data Discussion The NPB 40 prints summary report if available e stored snap shot data if available e sensor event data if available NPB 40 67 NPB 40 Operation Press the Menu button while in normal mode to access the parameter set up menu hierarchy Press the Menu button seven times to access the print data display The summary
32. ad Q Q I 3 Lu Z 2 OxIMAx NPB 40 Handheld Pulse Oximeter Operator s Manual Nellcor Puritan Bennett Inc is an affiliate of Tyco Healthcare Nellcor Oxiband Durasensor OxiClig Dura Y MAX FAST and Ox Max are trademarks of Nellcor Puritan Bennett Inc This ISM device complies with Canadian ICES 001 Cet appareil ISM est conforme 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 TE CN i ele UE iv E V Safety Information 2 00000004 240m Hanna 1 VE ll EE 1 Gaullons einen 3 Ke 4 free UO TEE 5 Intended Use for the NPB 40 uuneessnneneenessnnnnnnnen nn 5 How to Use this Manual uuuuersnnenennennnnnnnnnnnnnnnnnnnnn 5 Description of Controls Indicators and Symbols 7 Identification of Front Panel Buttons and Symbols 7 NPB 40 Symbols 00 ccceeeceeeeeeeeeeeeeeseeeeeeeeeesee
33. aeeseneees 11 Description of Controls ecccccesceeeeeeeeeeeeeeeeeeeeeeeeeees 13 Description of the Display and Indicators 16 Description of Audible Indicators 22 Set up the NP BAO E 25 List 0f Gomp nents urn 27 Connect OXIMAX Sensor to the NPB 40 27 Battery Operation E 31 Battery Power uueessnnessnensnnnnnnnnnnnnnnnnnnnnnnnnnnnennnn nn 31 Low Battery INdiCator ernennen nennen 31 Critical Battery Indication c ceceeeeeeeeeeeteeeeeeneeeeees 32 Battery Installation 444uen nn nnnnnennnnnnnn ernennen 33 NPB 40 Operation eege Eege 35 Introduction EEA A 35 Turn On the NPB 40 unnneeneessnnnnnenssnnnnnennnnnnnnnennnnnnn 36 DISCUSSION nennen 36 Procedure 38 OXIMAX Sensor Attached cccceeeseeeees 42 No OXIMAX Sensor Attached 44 Backlight On Off 40ersnnennnnnnnnnnnennnnnnnnnnnnnnnnn 44 Adjust Pulse Beep Volume 45 DISCUSSION u unsnnsee used mann een 45 Procedure Normal Operation 08 46 NPB 40 Contents Procedure Menu Structure 46 Adjust Alarm Volume 47 Discussion 47 Proced ra em astra 48 Set Time and Date ccccceceseseesseeceeeeeeeeseeeeeeeeneneaea 49 DISCUSSION Asa Erna ernennen nern 49 lte e EE 50 Set Alarm Silence Duration ccccccccccecceceeeeeeeeeeaeaes 54 Discussion
34. an SpO2 if hemoglobin levels fall below 5 gm dl Performance Considerations 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 Ox Max Sensor Performance Considerations gt gt gt NPB 40 WARNING Pulse oximetry readings and pulse signal can be affected by ambient conditions OxIMAx sensor application errors and patient conditions WARNING Tissue damage can be caused by incorrect application or inappropriate duration of use of an SpO2 OxMax sensor Inspect the Ox Max sensor site as directed in the Ox MAx sensor directions for use Warning Use only Nellcor approved OxiMax sensors and extension cables Do not use cables more than 4 feet in length Use only the DEC 4 extension cable or only the sensor 93 Performance Considerations 94 Inaccurate measurements can be caused by incorrect application of the Ox Max sensor placement of the Ox MAx sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line ambient light prolonged and or excessive patient movement intravascular dyes or externally applied coloring such as nail polish or pigmented cream failure to cover the OxiM4x sensor site with opaque material in high ambient light conditions
35. are different for OxIMAx sensors at a different revision level and by Ox MAx sensor type adhesive recycled and reusable The revision level of an OxIMAx sensor is located on the OxrMAx sensor plug Table 4 Ox Max Sensor Features Adhesive Recycled Reusable Sensors Sensors Sensors Feature Rev Rev Rev B Rev B A B OXIMAX Sensor Event Record Yes No No No Sensor Messages Yes Yes No Yes Sensor ID Message Yes Yes Yes Yes Biocompatibility Test Biocompatibility testing has been conducted on Nellcor OxiMax sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing The Ox Max sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993 1 83 OXIMAX Sensors and Accessories Optional Accessories 84 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 DEC 4 extension cable page 89 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 85 OXIMAX Sensors and Accessories Carrying Case 86 The Nylon carrying case is equipped with compartments for the NPB 40 Operator s manual compact disk containing all manuals and se
36. atient use infant 6 6 to 44 lbs OXIMAX adhesive sensor MAX R gt 50 kg 110 Ibs single patient use adult nasal OXIMAX OxiClig OxiClig A gt 30 kg 66 Ibs nonadhesive sensor single patient use adult reusable cable OXIMAX OxiCliq OxiCliq N lt 3 kg or gt 40 kg nonadhesive sensor lt 6 6 lbs or gt 88 Ibs single patient use neonatal adult reusable cable OXIMAX OxiCliq OxiCliq P 10 to 50 kg 22 to nonadhesive sensor 110 Ibs single patient use pediatric reusable cable 81 OXIMAX Sensors and Accessories Table 3 Nellcor Oximetry Sensor Models and Patient Weights Continued Patient Size Ox Max Sensor Model gt greater than lt less than OXIMAX OxiCliq OxiCliq I 3 to 20 kg nonadhesive sensor 6 6 to 44 lbs single patient use infant reusable cable OXIMAX Durasensor DS 100A gt 40 kg 88 lbs finger clip sensor reusable adult OXIMAX Oxiband sensor OXI A N lt 3 kg or gt 40 kg reusable neonatal adult lt 6 6 lbs or gt 88 Ibs OXIMAX Oxiband sensor OXI P I 3 kg to 40 kg reusable pediatric infant 6 6 lbs to 88 Ibs OXIMAX Dura Y multisite D YS gt 1kg 22 2 lbs sensor reusable For use with the Dura Y D YSE gt 30 kg 66 Ibs Ear clip Reusable nonsterile Segen 3 ke to 40 kg Pedi Check pediatric spot check clip Reusable nonsterile 6 6 lbs to 88 Ibs OXIMAX Sensors and Accessories Ox Max Sensor Features OxiM ax sensor features
37. ation cccccccecscsssesssseseseseees 136 ITOK EE 147 NPB 40 iil Contents Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 Figure 10 Figure 11 Battery Installation usu0 44444n en nnnnnnnnnnnnnnnnn nennen 33 lat ee e Il E EEN 69 Combined Printed Data ur 240u0snnnnnnnnnnnnnnnennnnnnn nn 71 PD 22T Setup Report A 73 NPB 40 Boot with Clip 2220uusnnennnnnennnnnnnnnnnnnnnnannnnn 85 NPB 40 Carrying Case 0 cecceeeeeeeceeeeeeeeeeeeeeeeeseeeeeeeeees 86 Water Resistant Jacket 87 SN VIE 87 Thermal Paper u ee 88 DEC 4 Extension Cable c cccceceeeeeeeeeeeeeeseeeeeeenneeeneaes 89 Oxyhemoglobin Dissociation Curve unnenennn 122 Contents Tables Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8 Table 9 Table 10 Table 11 Table 12 NPB 40 Flash Rates ans ins ek 18 Parameter Ranges eerren 35 Nellcor Oximetry Sensor Models and Patient Weights 80 OXIMAX Sensor Features neessnennennennnnnnnnnnnnnnnnnnnnnn 83 regele E 101 Menu Structure ae 114 Time Set MENU nase nn enden anna degree 115 Recommended Separation Distances c sceeeeees 137 Cable Compliance cccccceecceeeeceeeeeeeeeeeeeseeeeeeeesaeeeeaes 138 Electronic EMISSIONS 224444444440anennennnnnnnnnnnnnn nenn 139 Electromagnetic Immunity _ uuseennnennnennnnnnn
38. ation WARNING Pulse oximetry readings and pulse e Safety Information on page 1 e OXIMAX Sensors and Accessories on page 77 e OXIMAX Sensor Performance Considerations on page 93 NPB 40 27 Set up the NPB 40 Caution Use only Nellcor approved OxiM 4x sensors and extension cables A Note Physiological conditions medical procedures or external agents that may interfere with the NPB 40 s ability to detect and display measurements include e dysfunctional hemoglobin e arterial dyes e low perfusion e dark pigment e externally applied coloring agents such as nail polish dye or pigmented cream Inaccurate measurements can be caused by e incorrect application of the Ox Max sensor e placement of the OxzMax sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line e ambient light e prolonged and or excessive patient movement e intravascular dyes or externally applied coloring such as nail polish or pigmented cream e failure to cover the OxiMax sensor site with opaque material in high ambient light conditions 28 Set up the NPB 40 Loss of pulse signal can occur for the following reasons e the Ox Max sensor is applied too tightly e a blood pressure cuff is inflated on the same extremity as the one with the OxzMax sensor attached e there is arterial occlusion proximal to the OxzMax sensor e poor peripheral perfusion 1 SpO2 Ox MAx Sensor Port Connect a
39. ations 91 Dysfunctional Hemoglobins 92 Anemia anne nenn 92 SAatUrAtION eici cacdbuaxhatcwadennacdecdscsuaess 93 Pulse R tes 0 let aka 93 OXIMAX Sensor Performance Considerations 93 Troubleshooting u nn 99 Error amp Je EE 100 Corrective Action anessssesenenennneneneneensnennnnnnnnnnnnennnnnnn 102 EMI Electro magnetic Interference 105 Obtaining Technical Assistance en 106 Maintenance uuu2220n a2n000nnnnnnnunnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnunnnnnn 109 Return the NPB 40 uueesessesnnenssnnnnennnnnsennnnnnneneennenn 109 SENICE ids see eege ees egene 110 Periodic Safety Checks ennennenennnnnennnnnen 110 Gleaning EE 110 Menu Structure v4 dann ENEE EENS 113 Introduction cceeeececeeceeeeeseeececeauseeeeeeeaneeseeeeeseanseeees 113 SHUCHUrO een anna naeh 113 Principles of Operation unsuunnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 119 Oximetry Overview ccneenenneensnnennennnnnnnnnnnnnn mann 119 Automatic Calibration 120 Functional versus Fractional Saturation 121 Measured versus Calculated Saturation 121 OXIMAX Technology ccceecceeeteeeeeeeeeeeeeeeeeeneeeees 122 GE E 125 Eeer AN 125 SET le EE 132 Environmental Conditions cccccccccceeeeeeeeeeeeeeees 134 Physical Characteristics 135 Compliance anne ee 135 Manufacturer s Declar
40. ax sensor that tolerates some patient motion use anew OxIMAx sensor with fresh adhesive backing If poor perfusion affects performance consider using the MAX R Ox Max sensor or the MAX FAST OxIMAx sensor The MAX R Ox Max sensor obtains measurements from the nasal septal anterior ethmoid artery an artery supplied by the internal carotid These OxiMax sensors may obtain measurements when peripheral perfusion is relatively poor 95 Blank Page Performance Considerations NPB 40 97 Performance Considerations 98 Troubleshooting of any measurement check the patient s vital signs by alternate means then make sure the NPB 40 is functioning correctly WARNING If you are uncertain about the accuracy qualified service personnel There are no WARNING The cover should only be removed by user serviceable parts inside the NPB 40 NPB 40 its accessories connectors switches or Caution Do not spray pour or spill any liquid on the openings in the chassis NPB 40 99 Troubleshooting Error Codes When the NPB 40 detects an error condition it may display Er followed by the error code SpO2 O min 6 8 0 e A 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
41. d Motion Tolerance Continued Pulse Rate Without Motion 1 27 20 to 250 bpm 3 digits With Motion normal physiologic range u 55 125 bpm 5 digits Low Perfusion 20 to 250 bpm 3 digits 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 ProductManuals html 2 Applicability OxIMAx MAX A MAX FAST DS 100A D YSE SC NEO and OxiCliq A sensors Specification applies to NPB 40 performance Display Update Interval 100 millisecond Specifications Audible Indicators Audible Indicator Parameter Value Alarm Volume Setting Volume level Adjustable 40 to 52 dB A at one meter Pitch 30 Hz 752 Hz On pulse width 500 msec 20 msec Off Interval 20 msec 10 msec Number of pulses in 1 burst Repetition Pause N A 2 sec Priority 1 Beep Volume setting NPB 40 Volume level Adjustable 42 to 52 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 1 burst Repetition Pause N A 2 sec Priority 2 127 Specifications Audible Indicators Continued
42. d for the effects of variables that shift the relationship between PO2 and pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin See Figure Figure 11 NPB 40 121 Principles of Operation t pH 199 Temperature EE EE E PCO gt ae 2 2 3 DPG fie t Fetal Hb Gees 5 S pH 50 D t Temperature 5 VT PCO2 gt d t 2 3 DPG N 50 100 PO mmHg Figure 11 Oxyhemoglobin Dissociation Curve Ox Max Technology 122 The NPB 40 is designed to use Nellcor OxrMAx brand sensors which integrate the OxrMax technology These OxIMAx sensors can be identified by their deep lavender blue plug color All Ox Max sensors contain a memory chip carrying information about the Ox Max sensor which the oximeter needs for correct operation including the Ox Max sensor s calibration data model type troubleshooting codes and error detection data When an Ox Max sensor is connected to the NPB 40 the pulse oximeter will first reads the information in the Ox1Max sensor memory chip checks it to make sure that there are no errors and then loads the data to begin NPB 40 Principles of Operation monitoring As the pulse oximeter reads the information it displays the Ox Max sensor model number This process only takes a couple of seconds The OxIMAx sensor model number disappears after 5 seconds Pulse oximeters containing OxIMAx technology including the NPB
43. d 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 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 NPB 40 Blank Page Description of Controls Indicators and Symbols Identification of Front Panel Buttons and Symbols 1 SpO area of display 2 Measured SpO2 3 Pulse beats per minute BPM area of display 4 Measured BPM NPB 40 Description of Controls Indicators and Symbols 5 67 89 10 1112 16 15 1413 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 SpOz Limit Changed indicator NPB 40 Description of Controls Indicators and Symbols 17 18 1920 21 Q min O a wv 888 Da A 26 25 24 23 22 17 Low Battery indicator 18
44. dian ICES 001 approval 12 date of manufacture 11 decimal points 17 European union approval 11 fragile 13 keep away from heat 13 keep upright 13 protect from moisture 13 resistant to liquid ingress 11 Russian regulatory approval 12 see instructions for use 11 serial number 12 temperature limitation 13 type BF applied part 11 T 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 V verification 151 Index 152 performance 91 Ww warning water resistant jacket 87 wavelength 132 wavelength sensor 132 Y year 116 Index NPB 40 153 amp NELLCOR Tyco Healthcare Group LP 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 P013 0AS U K 2004 Nellcor Puritan Bennett Inc All rights reserved Rx ONLY tyco Healthcare 066989B 0904
45. distance for the WA N NPB 40 higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 137 Specifications 138 Table 9 Cable Compliance Cables Comply With e RF emissions EN 55011 Class B Group 1 e EN 60601 1 2 2001 Maximum Cables and OxiMax 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 76 2 cm MAX A sensor 1 5 ft 0 5 m MAX AL sensor 3 ft 0 9 m MAX I sensor 1 5 ft 0 5 m MAX N sensor 1 5 ft 0 5 m MAX P sensor 1 5 ft 0 5 m MAX R sensor 1 5 ft 0 5 m SC PR sensor 3 ft 0 9 m SC NEO sensor 3 ft 0 9 m SC A sensor 3 ft 0 9 m DS 100A sensor 3 ft 0 9 m OXI A N sensor 3 ft 0 9 m OXI P I sensor 3 ft 0 9 m D YS sensor 4 ft 1 2 m D YSE sensor 4 ft 1 2 m D YSPD sensor 4 ft 1 2 m 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 Emission Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The NPB 40 uses RF energy only for its internal function Therefore the RF emissio
46. during start up Power On 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 40 113 Menu Structure 114 Table 6 Menu Structure f rO Parameter Press Function Presses SpO2 Low Adjust limit Limit SpO2 High Adjust limit Limit BPM Low Adjust limit Limit BPM High Adjust limit Limit Pulse Beep Adjust volume Indications Volume on blip bar Alarm Adjust volume Indications Volume on blip bar Menu Structure Table 6 Menu Structure Continued of Presses 7 Print Data Print summary and or stored snap shot and sensor event data Table 7 Time Set Menu Parameter Press Function of Parameter Press Function Presses The must be pressed during the NPB 40 POST 1 Hour O Adjust 1 to 23 2 Minute O Adjust 1 to 59 3 Day O Adjust 1 to 31 NPB 40 115 Menu Structure Table 7 Time Set Menu Continued Q of Parameter Press Function Presses 4 Month O Adjust 1 to 12 5 Year O Adjust 2003 to 2099 When the month entry is made the NPB 40 checks the day selection to see if it is correct If the day selection is not valid for the month
47. e manual are available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html NPB 40 107 Blank Page Maintenance 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 institution should follow local Caution The NPB 40 will not operate with dead batteries Install new batteries Return the NPB 40 Contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Nellcor s Technical Services Department it is not necessary to return the OxzMax sensor or other accessory items with the NPB 40 Pack the NPB 40 in its original shipping carton If the original carton is not available use a suitable carton with appropriate packing material to protect it during shipping Return the NPB 40 by any shipping method that provides proof of delivery NPB 40 109 Maintenance Service remove the cover There are no user serviceable parts WARNING Only qualified service personnel should inside the NPB 40 The NPB 40 requires no calibration If service is necessary contact qualified service personnel or your local Nellcor representative Periodic Safety Checks It is recommended that the following checks be perform
48. econds may cause the decrement to repeat Press the Down Arrow button during normal operation to decrease the pulse beep volume NPB 40 Description of Controls Indicators and Symbols The Data Record Print button Press the Data button to store the currently shown SpOz and BPM values snap shot data to be stored The stored snap shot data can be printed In the print mode accessed via the Menu button the Data button starts the print function of single event report snap shot and or sensor event data The Menu Button Press the Menu button repeatedly during normal operation to sequentially display the seven parameter settable displays one for each button activation and then return to the default monitor display Settable parameters include high and low SpOz 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 Alarms and alarm icons such as Sensor Disconnected Pulse Search Motion and Low Battery as well as Alarm Silenced indicator are enabled when menu accessed parameter adjustment activities are activated and will display in the event of an alarm condition If the Menu button is pressed while Power On Self Test POST is activated the Time Date set display is displayed Repeated activations of the Menu button in this s
49. ected in the Ox MAx sensor Directions For Use WARNING Pulse oximetry readings and pulse signals can be affected by ambient environmental conditions OxIMAx sensor application errors and patient conditions WARNING Do not immerse or wet the Ox Max 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 Caution The Ox Max Sensor Disconnected icon and associated alarm indicate that either the OXIMAX sensor is disconnected or the wiring is faulty The user should check the OxrMAx sensor connection and if necessary replace the OxiMax sensor extension cable or both PP gt gt NPB 40 79 OXIMAX Sensors and Accessories 80 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 low perfusion dark pigment and externally applied coloring agents such as nail polish dye or pigmented cream For a complete and up to date listing of all Ox Max 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 Ox Max sensor consider the patient s weight and activity level the adequacy of perfusion and the available Ox MAx sens
50. ed every 24 months e Inspect the equipment for mechanical and functional damage e Inspect the safety relevant labels for legibility Cleaning NPB 40 its accessories connectors switches or Caution Do not spray pour or spill any liquid on the openings in the chassis For surface cleaning and disinfecting the NPB 40 follow the institution s procedures or 110 NPB 40 Maintenance e The NPB 40 may be surface cleaned by using a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water and lightly wiping the surfaces of the NPB 40 e 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 SpO2 OxrMax sensor read the directions for use enclosed with the OxzMax sensor Each Ox Max sensor model has cleaning instructions specific to that Ox MAx sensor Follow the OxzMax sensor cleaning and disinfecting procedures in the particular Ox7Max sensor s directions for use 111 Blank Page Menu Structure Introduction Pressing the Menu button repeatedly during normal operation sequentially displays seven parameter setting displays one for each button activation and then returns to the default monitoring display Settable parameters include high and low SpO limits high and low BPM limits alarm volume pulse beep volume and data printing Pressing the Menu button
51. en 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 Note When the NPB 40 times out 30 seconds the currently shown parameter and the NPB 40 display returns to the normal mode When the month entry is made the NPB 40 checks the day selection to see if it is correct Ifthe day selection is not valid for the month selected the menu display returns to the day selection display When the year entry is made the NPB 40 checks the day and month selections to see ifthey are correct Ifthe day or month selection is not valid for the year selected the menu display returns to the day selection display Some examples of illegal dates are e 30 February e 31 February s 31 April e 31 June 49 NPB 40 Operation e 31 September e 31 November e 29 February on a non leap year Procedure With the NPB 40 in the normal mode 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 The hours display 13 will flash SpOz2 Q min button until the desired hours are shown 4 Press the Up Arrow button or the Down Arrow 50 NPB 40 Operation 5 Press the Menu button to set the hours and display the minutes set display The minutes display 45 will flash SpO2 CO
52. ents 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 local ordinances and regulations Safety Information Cautions K 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 OxrMAax 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 NPB 40 3 Safety Information Notes Notes are identified by the NOTE symbol shown above Notes provide additional helpful information Introduction A WARNING Do not make any clinical judgments based solely on the NPB 40 The NPB 40 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Intended Use for the NPB 40 The Ox Max NPB 40 handheld pulse oximeter herein referred to as the NPB 40 is indicated for non invasive spot check measurements of functional arterial oxygen saturation SpOz and pulse rate of adult pediatric and neonatal patients It can be used in hospital emergency transport an
53. equence displays five 5 time date parameter set displays that allows the user to set Hour Minute Day Month and Year and then return to the POST display Description of Controls Indicators and Symbols The Backlight button Press the Backlight button to toggle the backlight ON or OFF The backlight will remain on for 9 5 to 10 5 minutes See Backlight On Off on page 44 The Up Arrow button Press the Up Arrow button sequentially to increase the parameter under adjustment by one increment Press and hold the Up Arrow button for more than three seconds to cause the increment to repeat 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 Description of the Display and Indicators 16 SpOz Q min NPB 40 Description of Controls Indicators and Symbols The NPB 40 display includes a Pulse Amplitude blip bar functional icons and current measured SpO2 and pulse rate A decimal point after the SpO or pulse rate indicates that the respective limits have been changed from the power on default values Table 2 on page 35 Decimal points after the SpO or pulse rate indicate that the respective limits have been changed from the power on default values There are various mat
54. he 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 The current copy of the NPB 40 service manual is available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html Following is a list of possible errors and suggestions for correcting them 102 NPB 40 Troubleshooting There is no response to the Power button Ensure that the Power button is fully depressed The batteries may be missing discharged or oriented incorrectly Install new batteries See Battery Installation on page 33 2 One or more display segments or indicators do not light during the power on self test Do not use the NPB 40 contact qualified service personnel or your local Nellcor representative 3 The Pulse Search indicator is displayed for more than 10 seconds Check the sensor directions for use to determine if an appropriate sensor is being used and if it is applied properly Check sensor and extension cable connections 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 Excessive patient motion may be preventing the NPB 40 from tracking the
55. hemoglobin differ in their absorption of red and infrared light spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the NPB 40 119 Principles of Operation pulsatile cycle Red and infrared low voltage light emitting diodes LED in the oximetry OxiMax sensor serve as light sources a photo diode serves as the photo detector Because oxyhemoglobin and deoxyhemoglobin differ in light absorption the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation To identify the oxygen saturation of arterial hemoglobin the monitor uses the pulsatile nature of arterial flow During systole a new pulse of arterial blood enters the vascular bed and blood volume and light absorption increase During diastole blood volume and light absorption reach their lowest point The pulse oximeter bases its SpO2 measurements on the difference between maximum and minimum absorption measurements at systole and diastole By doing so it focuses on light absorption by pulsatile arterial blood eliminating the effects of nonpulsatile absorbers such as tissue bone and venous blood Automatic Calibration 120 Because light absorption by hemoglobin is wavelength dependent and becau
56. heoretically with accuracy 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 If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the NPB 40 gt Over the frequency range 150 kHz to 80 MHz field strength should be less than V V m 142 Specifications NPB 40 143 Specifications 144 Index NPB 40 Symbols SpO2 high limit 114 SpO2 low limit 114 A accessories 84 accuracy and motion tolerance 125 alarm limit display 59 alarm silence duration 54 alarm silence indicator 19 alarm volume 114 anemia 92 audible indicator 127 B biocompatibility testing 83 boot 85 bpm high limit 114 bpm low limit 114 C 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 15 147 Index 148 down arrow 14 16 menu 15 power 16 up arrow 16 D 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 E electromagnetic interference 105 error codes 100 exp
57. ht remains on the display cycles through the following sequence as POST takes place e all display graphics are shown for three seconds the backlight is turned on at this time the display goes blank all display elements off for one second the version number of the software is shown as a three digit number in the right hand number field with foremost zeros if the version number is less than 100 and two dashes in the left hand number field for three seconds the current time of day 24 hour format is shown for three seconds successful completion of POST is announced by a POST pass tone A failed POST is announced by a high priority alarm tone 37 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 38 NPB 40 Operation 3 The display goes blank for one second SpOz2 4 The software version number is shown for three seconds The software version is identified by two dashes in the SpOz area of the display The software version number is shown with foremost zeros for software version numbers less than 100 SpOz2 CH LV min Se ee 0 A A A Note The software version shown above is only a sample Check the NPB 40 for the software version installed NPB 40 39 NPB 40 Operation A
58. ient for five minutes and every five minutes thereafter The maximum number of events that can be stored in an Ox Max sensor is 100 75 OXIMAX Sensor Event Record 76 Event records can only be viewed after an Ox Max sensor containing patient data event records has been connected to an Ox Max 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 patient events from prior areas of care or transport history while monitor trend should be used to view data or events from a patient currently being monitored The monitor s Data In Sensor indicator will light when an Ox Max sensor containing sensor event data is connected to the OxrMAx monitor Recording and viewing of OxIMAx sensor event data is only available on Ox M4x comparable monitors The Ox1Max sensors may function on older technology monitors but the Ox MAx sensor event record feature is not available OXIMAX Sensors and Accessories A A 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 WARNING Failure to cover the OxiMax sensor site with opaque material in high ambient light conditions may result in inaccurate measurements
59. ings and pulse e Safety Information on page 1 e OXIMAX Sensors and Accessories on page 77 e Performance Considerations on page 91 Performance Verification The performance of the NPB 40 is verified by following the procedures outlined in the 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 NPB 40 91 Performance Considerations Inaccurate measurements can be caused by e prolonged and or excessive patient movement venous pulsations e intravascular dyes such as indocyanine green or methylene blue e externally applied coloring agents nail polish dye pigmented cream e defibrillation Dysfunctional Hemoglobins Dysfunctional hemoglobins such as carboxyhemoglobin methemoglobin and sulphemoglobin are unable to carry oxygen SpO2 readings may appear normal however a patient may be hypoxic because less hemoglobin is available to carry oxygen Further assessment beyond pulse oximetry is recommended Anemia 92 Anemia causes decreased arterial oxygen content Although SpO readings may appear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The monitor may fail to provide
60. losion hazard 1 extension cable DEC 4 89 F fractional saturation 121 front panel buttons 7 symbols 7 functional saturation 121 H hour 115 how to use this manual 5 NPB 40 Index I indicator alarm silenced 19 low battery 19 motion 19 pulse amplitude 18 infrared printer 87 intended use 5 L list of components 27 low battery indicator 19 31 M manufacturer s declaration 136 measured saturation 121 menu structure 113 minute 115 monitor performance considerations 91 monitor displays dashes 44 month 116 motion indicator 19 N NPB 40 measurement range 125 returning 109 O operating altitude 134 relative humidity 134 temperature 134 optional accessories 84 OXIMAX technology 122 149 Index 150 oximetry overview 119 P 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 R recommended separation distances 137 S safety checks 110 saturation calculated 121 fractional 121 functional 121 measured 121 selecting a sensor 80 sensor performance considerations 93 selection 80 sensor event record 76 sensors 132 specifications 125 battery 132 compliance 135 electrical 132 environmental 134 NPB 40 Index performance 125 physical 135 storage altitude 134 relative humidity 134 temperature 134 symbols 11 Cana
61. m Silence button to set the alarm silence duration to OFF and return to normal operation SpO2 Q min Note The Alarm Silenced indicator will flash and an audible reminder sounds every three minutes while the alarm silence duration is set to OFF 58 NPB 40 Operation Set Alarm Limits Discussion The Alarm Limit display allows the user to adjust the upper and lower saturation and pulse rate limits Pressing the Up Arrow or Down Arrow button for three seconds or more causes the increment or decrement to scroll The Alarm Limit Changed indicator is displayed anytime an alarm limit is being changed or has been changed 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 Procedure NPB 40 With the NPB 40 in the normal mode 1 Press the Menu button The SpO2 lower alarm limit is shown 59 NPB 40 Operation A Note The SpO2 low alarm limit range is 20 to 99 The upper value of the SpO2 low alarm limit is limited to the SpO2 upper alarm limit The SpOz low alarm limit cannot be set equal to or higher than the SpO2 upper alarm limit SpOz Q min DC D WWW ee 9 el 2 Press the Up Arrow or Down Arrow buttons to increase or decrease the shown limit parameter 3 Press the Menu button to set the limit value The SpO upper alarm limit
62. n 136 A WARNING The use of accessories sensors and cables other than those specified may result in increased emission and or create invalid readings of the 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 communications equipment transmitters and the NPB 40 as recommended below according to the maximum output of the communications equipment Specifications Table 8 Recommended Separation Distances Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the NPB 40 IEC 60601 1 2 Frequency of 150 kHz to 80 MHz to 800 MHz to Transmitter 80 MHz 800 MHz 2 5 GHz Equation 3 3 3 5 7 d LH d Ein d 7 Rated Separation Separation Separation Maximum Distance in Distance in Distance in Output Power Meters Meters Meters of Transmitter in Watts 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz to 800 MHz the separation
63. nennnnnnnn nen 140 Electromagnetic Immunity _ useersnnennnnnnnnnnnnennnnnnn nen 141 v Blank Page Safety Information Warnings A A A NPB 40 A Warnings are identified by the WARNING symbol shown above Warnings alert the user to potential serious outcomes 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 WARNING Explosion hazard Do not use the 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 NPB 40 has a broken display panel Safety Information b E EE gt gt 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 NPB 40 WARNING Failure to cover the OxiMax sensor site with opaque material in high ambient light conditions may result in inaccurate measurem
64. ns are very low and not likely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class B The NPB 40 is suitable for use in establishments including diagnostic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes NPB 40 139 Specifications Table 11 Electromagnetic Immunity The NPB 40 is intended for use in the electromagnetic environment specified below The customer or user ofthe NPB 40 should assure that itis used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Electrostatic 6kV contact Complies Floors should be Discharge ESD wood concrete or 8 kV air ceramic tile If IEC 61000 4 2 floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV power Complies Main power should transient burst supply lines be that of a typical commercial or IEC 61000 4 4 1 kV for hospital input output environment lines Power 3 A m Complies Power frequency Frequency magnetic fields 50 60 Hz should be at levels magnetic field characteristic of a typical location in a typical commercial or hospital environment 140 Specifications Table 12 Electromagnetic Immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level
65. nsors The case comes with a carrying strap that is adjustable from 71 cm to 135 cm 28 inches to 53 inches Figure 6 NPB 40 Carrying Case OXIMAX Sensors and Accessories Water Resistant Jacket The water resistant jacket is made of clear plastic to facilitate use of the NPB 40 Q O we o SCH Figure 7 Water Resistant Jacket Infrared Printer Figure 8 Printer NPB 40 87 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 Thermal Paper The thermal paper is for the Citizen PD 22 infrared printer Refer to the User s Manual supplied with the printer for details on the thermal paper Figure 9 Thermal Paper 88 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 89 OXIMAX Sensors and Accessories Blank Page 90 Performance Considerations signals can be affected by ambient environmental conditions OxIMAx sensor application errors and patient conditions See the appropriate sections of the manual for specific safety information WARNING Pulse oximetry read
66. ons When a valid pulse is detected the NPB 40 enters the normal mode and displays patient parameters SpO2 Wel V min Movement of the blip bar indicates that real time data is being displayed Listen for the pulse beep tone If the pulse beep tone does not sound with each pulse it is an indication that the pulse beep volume is set to zero the speaker has malfunctioned or the signal is corrupted NPB 40 NPB 40 Operation When an Ox7Max sensor is attached to the NPB 40 and is applied to a patient and the NPB 40 loses the pulse signal the NPB 40 will display amp two dashes and two dashes and display the Pulse Search icon for five seconds before the Sensor Disconnected icon is displayed SpO2 Gel LV min SpOz2 Q min 43 NPB 40 Operation No Ox Max Sensor Attached Upon successful completion of POST the NPB 40 sounds a one second tone that indicates that the NPB 40 has passed POST SpOz2 Q min 5 0 0 0 eo The NPB 40 displays dashes and the Pulse Search indicator is not displayed when the NPB 40 fails to detect an OxiMax sensor Backlight On Off A Note The backlight will automatically turn off after La 9 5 seconds to 10 5 seconds With the NPB 40 turned on press the Backlight button amp to turn the NPB 40 backlight on or off 44 NPB 40 Operation Adjust Pulse Beep Volume Discussion NPB 40 There are two ways to adjust the pulse beep volume
67. or sites the need for sterility and the anticipated duration of monitoring For more information refer to Table 3 on page 80 or contact your local Nellcor representative Refer to Performance Considerations on page 91 for more information on Ox Max sensor performance Table 3 Nellcor Oximetry Sensor Models and Patient Weights Patient Size Ox Max Sensor Model gt greater than lt less than OXIMAX MAX FAST MAX FAST gt 10 kg 22 lbs adhesive forehead sensor single patient use OXIMAX Softcare SC PR lt 1 5 kg 3 3 Ibs nonadhesive sensor single patient use preterm infant OXIMAX Softcare SC NEO 1 5 to 5 kg nonadhesive sensor single 3 3 to 11 lbs patient use neonate NPB 40 OXIMAX Sensors and Accessories Table 3 Nellcor Oximetry Sensor Models and Patient Weights Continued Patient Size Ox1Max Sensor Model gt greater than lt less than OXIMAX Softcare SC A gt 40 kg 88 Ibs nonadhesive sensor single patient use adult OXIMAX adhesive sensor MAX A gt 30 kg 66 lbs single patient use adult OXIMAX adhesive sensor MAX AL gt 30 kg 66 lbs single patient use adult longer cable 36 inches 91 44 cm OXIMAX adhesive sensor MAX N lt 3 kg or gt 40 kg single patient use neonatal lt 6 6 lbs or gt 88 Ibs adult OXIMAX adhesive sensor MAX P 10 to 50 kg single patient use pediatric 22 to 110 lbs OXIMAX adhesive sensor MAX I 3 to 20 kg single p
68. printed The Data In Sensor indicator displays when the sensor memory is full Upper Alarm Limit indicator The Upper Alarm Limit indicator indicates that the displayed value is the upper alarm limit for SpO or Pulse Rate Lower Alarm Limit indicator The Lower Alarm Limit indicates that the displayed value is the lower alarm limit for 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 The Print indicator flashes when the NPB 40 is prints single event snap shot or sensor event data C YO AD RW NPB 40 Description of Controls Indicators and Symbols Sensor Disconnected indicator The Sensor Disconnected indicator displays when the patient sensor is disconnected from the NPB 40 Alarm Volume Adjust indicator The Alarm Volume Adjust indicator is displays when the NPB 40 is in the alarm volume adjust mode 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 Set Limit mode indicator The Set Limit mode indicator displays when the NPB 40 alarm limit values are under adjustment
69. pulse Keep the patient still if possible Verify that the sensor is securely applied and replace it if necessary Change the sensor site 103 Troubleshooting 104 The sensor may be too tight there may be excessive ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary Excessive environmental motion or electromagnetic interference may be preventing the NPB 40 from tracking the pulse Remove the source of interference or try to stabilize the environment or do both 4 The Pulse Search indicator lights after successful measurements have been made 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 Verify that the sensor is securely applied and replace it if necessary Change the sensor site The sensor may be too tight there may be excessive ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary Troubleshooting e Excessive environmental motion or electromagnetic interference may be preventing the NPB 40 from tracking the pulse Remove the source of interference or try to stabilize the environment or do both 5 Er followed
70. rices within the Ox Max algorithm Some of these are used to assess the severity of conditions presented to the NPB 40 in SpO gt and pulse rate measurements on a patient These individual matrices or combinations of these matrices are used to drive the icon indicators on the NPB 40 front panel The Ox Max algorithm automatically extends the amount of data required for measurements of SpO2 and pulse rate dependent on the measurement conditions Throughout normal measurement conditions the averaging time is six to seven seconds Throughout challenging measurement conditions that could be caused by low perfusion motion external interference like ambient light or a combination of these the Ox Max algorithm automatically extends the amount of data required beyond seven seconds If the resulting dynamic averaging time exceeds 20 seconds the Pulse Search indicator is displayed and SpO gt and Pulse Rate display is continue to be updated every second As these conditions become even more challenging the amount of data required continues to extend If the dynamic averaging time reaches 40 seconds the Pulse Search indicator begins to flash the SpO2 and pulse rate displays flash zeros to indicate a loss of pulse condition Description of Controls Indicators and Symbols 18 SpOz2 Oo Jo Selected display elements icons numerals etc may flash There are three flash rates See Table 1 Table 1 Flash Rates Priority
71. rst Repetition Pause 0 sec 2 sec Priority 11 Electrical Batteries The batteries provide at least 15 hours of battery life with no alarms no printing and with backlight on while using a pulse simulator set for 200 bpm high light and low modulation Type 4 AA alkaline Voltage 1 5 Volts DC each Ox Max Sensors Wavelength The wavelength range of the light emitted are near 660 nm and 890 nm 132 Specifications Ox Max Sensor Power Dissipation Sensor Dissipation OXIMAX MAX N 52 5 mW OXIMAX MAX I 52 5 mW OXIMAX MAX P 52 5 mW OXIMAX MAX A 52 5 mW OXIMAX MAX AL 52 5 mW OXIMAX MAX R 52 5 mW OXIMAX Durasensor DS 100A 52 5 mW OXIMAX OxiClig P 52 5 mW OXIMAX OxiClig N 52 5 mW OXIMAX OxiClig I 52 5 mW OXIMAX OxiClig A 52 5 mW OXIMAX Dura Y D YS 52 5 mW OXIMAX MAX FAST 52 5 mW OXIMAX Softcare SC PR 52 5 mW OXIMAX Softcare SC NEO 52 5 mW OXIMAX Softcare SC A 52 5 mW OXIMAX Oxiband OXI A N 52 5 mW NPB 40 133 Specifications Environmental Conditions 134 Operation Temperature 5 C to 40 C 41 F to 104 F Altitude 390 m to 3 012 m 1 254 ft to 9 882 ft Atmospheric Pressure Relative Humidity 70 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg 15 to 95 non condensing Transport and Storage not in shipping container Temperature Altitude 20 C to 60 C 4 F to 140 F 390 m to 5 5
72. se the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the Ox Max sensor s red LED to accurately measure SpO2 During monitoring the NPB 40 s software selects coefficients that are appropriate for the wavelength of that individual Ox Max sensor s red LED these coefficients are then used to determine SpO2 Additionally to compensate for differences in tissue thickness the light intensity of the Ox Max sensor s LEDs is adjusted automatically Principles of Operation Functional versus Fractional Saturation This pulse oximeter measures functional saturation oxygenated hemoglobin expressed as a percentage ofthe hemoglobin that can transport oxygen It does not detect significant amounts of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin In contrast hemoximeters such as the IL482 report fractional saturation oxygenated hemoglobin expressed as a percentage of all measured hemoglobin including measured dysfunctional hemoglobins To compare functional saturation measurements to those from an instrument that measures fractional saturation fractional measurements must be converted as follows Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen PO2 the calculated value may differ from the SpOz measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately correcte
73. trols Indicators and Symbols These symbols are also used on the NPB 40 labels KEN Keep away from heat y Temperature limitation c A Protect from moisture T Fragile MM g Keep upright NPB 40 13 Description of Controls Indicators and Symbols 14 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 Ifthe key pressed fails to emit a tone contact qualified service personnel The Alarm Silence button Press the Alarm Silence button to silence audible alarms within 1 5 seconds after the start of the alarm If the Alarm Silence button is pressed when no audible alarm is active alarms during the alarm silence duration will be silenced In all cases the alarm silence shall time out after the selected alarm silence duration and auditory alarm capability is reactivated Note Alarms that occur throughout Power On Self Test POST cannot be silenced Press and hold the Alarm Silence button for three seconds to invoke the Alarm Silence Duration menu which allows the alarm silence interval to be adjusted from 30 60 90 or 120 seconds or to OFF alarms disabled See Set Alarm Silence Duration on page 54 The Down Arrow button Press the Down Arrow button to sequentially decrease the parameter under adjustment by one decrement Press and hold the Down Arrow button for more than three s
74. ur AA size batteries orientated as shown in Figure 1 3 Replace the battery access door 1 Battery compartment latch Figure 1 Battery Installation NPB 40 33 Battery Operation 34 gt E E E WARNING Explosion hazard Do not use the 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 WARNING To ensure accurate performance and prevent device failure do not expose the NPB 40 to extreme moisture such as rain Introduction NPB 40 Operation 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 Table 2 Parameter Ranges Parameter Ranges Factory Selections Defaults SpO2 Upper Lower Alarm 100 Alarm Limit Limit plus 1 to 100 SpO2 Lower 20 to Upper 85 Alarm Limit Alarm Limit minus 1 Pulse Rate Upper Lower Alarm 170 bpm Alarm Limit Limit plus 1 to 250 bpm Pulse Rate Lower 30 bpm to Upper 40 bpm Alarm Limit Alarm Limit minus 1 35 NPB
75. urce of this disruption and the following actions taken to eliminate the source e Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the interfering equipment Increase the separation between the interfering equipment and this equipment The NPB 40 generates uses and can radiate radio frequency energy and if not installed and used in accordance with these instructions may cause harmful interference with other devices in the vicinity If assistance is required contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative Obtaining Technical Assistance 106 For technical information and assistance or to order parts or a service manual contact Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative The service manual includes block diagrams and a parts list required by qualified personnel when servicing the NPB 40 Troubleshooting When calling Nellcor s Technical Services Department 1 800 635 5267 or your local Nellcor representative you may be asked to tell the representative the software version number of the NPB 40 The software version appears in the NPB 40 display each time the NPB 40 successfully completes the power on self test Write the number down and have it available whenever requesting technical assistance The current copy of this manual and the NPB 40 servic

Nellcor NPB-40 Handheld Pulse Oximeter User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents