Nellcor N40 Operator`s Manual
Contents
1. Single Event Report or a Multiple Event Report 25 Start Up and Use Single Event Report 26 To initiate a single event report the sensor must be on the patients finger and the NPB 40 must be displaying readings When there are no monitoring events stored in memory pressing the Shift Print key will result in the monitor generating the Print Display and sending a Single Event Report to the printer This report contains the current oxygen saturation and pulse rate information The format for the Single Event Report follows e Name of the monitor NPB 40 e Notes Line approximately 1 2 inch of space for handwritten notes e Elapsed time e SpO2 and BPM pulse rate readings including minimum maximum and average values See Figure 7 for a sample Single Event Report elapsed time 00 03 14 Sspozx 100 5p 2 minimum 99 Spo24 maximum 100 Sp02 average 99 BPH 87 BPM minimum 8i BPM maximum 29 BPM average 398 Levey a AAA aH IL Figure 7 Single Event Report Start Up and Use Multiple Event Report When the Shift Print keys are pressed and there are one or more monitoring events stored in memory the monitor generates the Printing Display and sends a Multiple Event Report to the printer starting with the first event that was stored in memory Note This mode will not print out the current SpO2 and pulse rate only the stored events The Multiple Event Report contains the following component2. damage to the monitor may occur Caution Do not use lithium batteries with the NPB 40 Lithium batteries will damage the monitor The NPB 40 pulse oximeter is powered by four alkaline AA cell batteries Typically a fresh set of disposable AA batteries will provide 19 hours of continuous monitoring with the display backlight OFF Note Not all brands of off the shelf alkaline batteries provide the same battery life Note Do not mix alkaline AA batteries with rechargeable batteries When replacing batteries replace with four fresh new batteries Do not mix used and new batteries Start Up and Use Note If the batteries are low when the monitor is turned on the Low Battery indicator will not flash until the instrument enters normal operation When 45 minutes or less of disposable alkaline battery life remains the Low Battery indicator lights and a triple beep tone occurs at 3 minute intervals Rechargeable alkaline batteries may be used with the NPB 40 It must be noted however the battery life per charge will be less than that typical for disposable batteries In addition each subsequent charge of the rechargeables will yield shorter battery life cycles For example a typical set of rechargeable alkaline batteries will usually yield 10 hours of continuous monitoring of the NPB 40 but each recharge will provide a shorter monitoring time until the average battery life cycle is about 3 5 hours per
3. sareei eeen Vir eana baranes 21 Pulse Search Mode ccccceeeeeeeeeeeee caeeeeneeeeneeeseaees 22 Determining Software Version ccseeeeeeeeeeeeeeeeteeeeeteee 23 Silencing or Adjusting Pulse Beep Volume 06 23 Turning Display Light Backlight On or Off eee 23 Storing Event Datta ereat EEEE a EE 23 Printing Event Data 00 neton tga mea ar eaer 24 iii Contents Preparing the NPB 40 for Printing seese 24 Single Event Report cccceecceseeeeetee ceeeeseneeseneeeeaees 26 Multiple Event Report 00 0 0 cceeeseeeeeesnee eeeeeeeeeeeeeaeees 27 Printer and Printer Accessories s e 28 Sensor Disconnect Indicator cc eeeeeeeeeeteee serere 28 Battery Operation c ccccceeceeeeeeeeee ceeeeeeeeeeeeeeeneeeteeeetees 28 Disposal of Device Component ceeeeeeeeeenee eeeeeeees 29 Performance Considerations cceeseeeeeeesee errereen 30 Impact of Patient Conditions on Monitor Readings 30 TROUBLESHOOTING AND MAINTENANCE sse 31 TTOUDICSHOOTING raseeris raneta anny E ENSE aE EE EES 31 EMI Interference eccceeeceeeeeseeetee ceeeeenseeesenseeeeeneeeenensees 33 Obtaining Technical Assistance ccccceeeeeteee eee 34 Returning the NPB 40 ooo cee ceeeeceeeeseeeeeene eeeeesneeeeeenaeeeees 34 Maintenance easg ee aae tiie aet are a e 35 OO OE a a Aeae AAE tte estab AEREE 35 CleaniN gesais ane ira aine aaa aaaea eaea 35 Periodic Safety Ch
4. the NPB 40 monitor Other important safety information appears throughout the manual in sections that relate specifically to the precautionary information Be sure to read all text surrounding all precautionary information Important Before use carefully read this manual accessory directions for use all precautionary information in boldface type and specifications WARNING The NPB 40 is a prescription device and is to be operated by qualified personnel only WARNING The NPB 40 is not equipped with alarms The monitor is for attended monitoring only and must be used under the direct supervision of a qualified health care provider WARNING Explosion hazard Do not use the NPB 40 pulse oximeter in the presence of flammable anesthetics WARNING The cover should be removed only by qualified service personnel There are no user serviceable parts inside WARNING To ensure accurate performance and prevent device failure do not expose the NPB 40 to extreme moisture such as rain Caution The NPB 40 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions Safety Information To ensure accurate readings consider the environmental conditions that are present and the condition of the pati
5. 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 monitor bases its SpO2 measurements on the difference between maximum and minimum absorption i e 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 41 Appendix Principles of Operation Automatic Calibration Because light absorption by hemoglobin is wavelength dependent and because the mean wavelength of LEDs varies an oximeter must know the mean wavelength of the sensor s red LED to accurately measure SpO2 During manufacturing the mean wavelength of the red LED is encoded in a resistor in the sensor During monitoring the instrument s software reads this resistor and selects coefficients that are appropriate for the wavelength of that sensor s red LED these coefficients are then used to determine SpO2 This resistor is read when the monitor is turned on periodically thereafter and each time a new sensor is connected Additionally to compensate for differences in tissue thickness the intensity of the sensor s LEDs are adjusted automatically Functional versus Fractional Saturation 42 This monitor measures func
6. PB 40 is designed to send previously stored patient data to an external Hewlett Packard HP82240B printer available from Mallinckrodt GENERAL OPERATING PRINCIPLES AND CONDITIONS The NPB 40 uses pulse oximetry to measure oxygen saturation in the blood Pulse oximetry works by applying a sensor to pulsating arteriolar vascular bed such as a finger or toe The sensor contains a dual light source and a photodetector Introduction 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 in an oxygen saturation measurement SpO2 Because a measurement of SpO2 is dependent on light from the sensor excessive ambient light can interfere with this measurement WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions Specific information about ambient environmental conditions sensor application and patient conditions is contained throughout this manual CONTROLS INDICATORS AND SYMBOLS Displays Controls Indicators and Connectors Other NPB 40 Symbols Description of Controls Description of Visible Indicators and Displays Description of Audible Indicators DISPLAYS CONTROLS INDICATORS AND CONNECTORS Figures 1 through 4 show th
7. Q NELLCOR OPERATOR S MANUAL NPB 40 Handheld Pulse Oximeter Caution Federal law U S restricts this device to sale by or on the order of a physician To contact Mallinckrodt s representative In the United States call 1 800 635 5267 outside of the United States call your local Mallinckrodt representative 2001 Mallinckrodt Inc All rights reserved 060328B 0601 0123 Nellcor Puritan Bennett Inc 4280 Hacienda Drive Pleasanton CA 94588 USA Telephone Toll Free 1 800 NELLCOR Tyco Healthcare UK LTD Fareham Road Gosport PO13 OAS U K Tel 44 1329 224000 Nellcor Puritan Bennett Inc is a wholly owned subsidiary of Mallinckrodt Inc Nellcor and Nellcor Puritan Bennett are trademarks of Mallinckrodt Inc To obtain information about a warranty if any for this product contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative The following are trademarks of Mallinckrodt Inc Durasensor Oxiband Oxisensor Oxisensor II OxiCliq and Dura Y Covered by one or more of the following U S Patents and foreign equivalents 4 621 643 4 685 464 4 700 708 and 4 770 179 CONTENTS Figures Tables FIGUES arin tidak Win bived veeeen ETA E tae iii TADES era A T E bats ceaeeni enti jii SAFETY INFORMATION 0 c cceeeceeeeeeeeeeeee iniiai netya 1 General Safety Information 0 cccceeeeeeeeeeeeceeeeteeteteeees 1 INTRODUCTION eian a sia Ati pete noes e
8. charge Note Because of this decrease per charge cycle the Low Battery Indicator and battery life specification quoted for disposable alkalines will not apply to rechargeables Regardless of what battery type is used when the remaining battery life is insufficient to operate the monitor within its specifications the NPB 40 sounds two triple beeps and turns itself off Caution Remove the batteries from the NPB 40 prior to storing the monitor for an extended period of time DISPOSAL OF DEVICE COMPONENTS Caution Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components including batteries 29 Start Up and Use PERFORMANCE CONSIDERATIONS Impact of Patient Conditions on Monitor Readings Certain patient conditions can affect the measurements of the NPB 40 and cause the loss of the pulse signal WARNING Pulse oximetry readings and pulse signals can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions Inaccurate measurements can be caused by e excessive patient movement e venous pulsations e intravascular dyes such as indocyanine green or methylene blue e significant levels of dysfunctional hemoglobins e defibrillation Ambient environmental conditions and sensor application errors which can affect pulse oximetry readings are discussed in the Nellcor Sensors section of this manual and in the
9. ct anything other than an SpO2 sensor to the sensor port for example do not attempt to connect a PC to the NPB 40 Note It is recommended that a sensor be connected prior to start up If no sensor is connected at start up an error tone sounds for approximately 3 seconds 1 Plug an appropriate Nellcor sensor firmly into the sensor port and apply the sensor to the patient as described in the sensor directions for use If needed use a Nellcor sensor extension cable model EC 4 or EC 8 Caution During the self test immediately after power up confirm that all display segments and icons light 2 Turn on the NPB 40 by pressing the On Off key The monitor automatically conducts a power on self test which tests its circuitry and lights the entire numeric display 3 While performing the power on self test POST the POST Display appears for approximately 3 5 seconds During this time e All icons light e All segments of all numeric digits light e All segments of the Pulse Amplitude Display light Display backlight is turned on During POST check to ensure that all display icons and numeric segments light If any icon or numeric segment does not light do not use the monitor Instead contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative 4 Ifthe NPB 40 detects an internal problem during POST an error tone sounds and the monitor displays an Error Code and corresponding numb
10. e 3 Minded USE x aonne E O EA haba hee 3 General Operating Principles and Conditions 3 CONTROLS INDICATORS AND SYMBOLS oae 5 Displays Controls Indicators and Connectors 5 Other NPB 40 Symbols cccceeceeeeeeeseeeeneeeeee ceeeeeaeetaes 7 Description of Controls ceeeceeeeeeeeeeeeeeeeeeeeeeeeaaaeees 8 FUNGON KEYS a E a N AE ERLE 8 Status TC0NS aiea ae a aaa aa e ioe aaie 8 Description of Visual Indicators and Displays 9 Description of Audible Indicators eceeeeeeeeeeee rere 10 SETUP an kian a a a aE aE merece 11 Unpacking and INSpection eeeecceeeeeeeeeeceeeeeeenneeeeeees 11 TEST ested sscalieisey ase E ERA 11 List of Components ccceceeeeeeceeeeeee ceeeeeeeeeaeeeeeeeeseaeetees 11 Optional Accessories ccecceeeeeeeeeetetee ceeeteeeeteaeetees 11 Monitor Setup imom et atte canine aaetadel ta eea aietan 12 Installing the Batteries ee eeeeeeeseeeeee eerren 12 General esi cuneate a eeee aladdin aae ea 13 NELLCOR SENSORS perias atearen harakat Es Rie ie Ra es 15 Selecting a Sensor 00 eeceeeceeceeeeseeeeeee ceeeeeeneeeteeeteteeeeeeees 15 Biocompatibility Testing ceecee ereere 16 Performance Considerations ccccecceeeeeeteee eerren 16 START UP AND USE carae a kaaa aE aaa aaea REER 19 Basic Operation iisi elatohaie ede etiieueentiteiciee 19 Power On Self Test POST s e eeen 20 Monitoring Mode
11. e front side rear and top views of the NPB 40 and identify displays controls and connectors 1 Function keys 2 Status icons 3 Digital display 4 Sensor port Figure 1 NPB 40 Front Side View Controls Indicators and Symbols ONO G1 GN eo 1 Fant 2 5 oO 14 3 13 Or 4 12 5 11 6 10 9 8 7 Pulse Amplitude indicator 9 Shift Print key Pulse Rate display 10 Store Data key Pulse Search indicator 11 Shift Key Low Battery indicator 12 Store Data icon Sensor Disconnect indicator 13 Shift Key icon Power On Off key 14 Print icon Shift Beep On Off key 15 SpO02 display Display Light key Figure 2 NPB 40 Front Panel Display 1 Sound ports 2 Battery compartment latch 3 Battery compartment door Figure 3 NPB 40 Rear View Controls Indicators and Symbols 1 Printer infrared window Figure 4 NPB 40 Top View OTHER NPB 40 SYMBOLS A Attention See Instructions for Use SpO2 Percent oxygen saturation Q min Pulse rate measured in beats per minute bpm Type BF equipment Alkaline AA size 1 5 V batteries Controls Indicators and Symbols DESCRIPTION OF CONTROLS Function Keys of Status Icons g gt Power On Off key This key is used to turn the NPB 40 monitor on or off Shift key When pressed in conjunction with another Function key the Shift key changes the function of the other key to that designated by its upper icon Combo 1 key Wh
12. ecks a essssrerssrrresrerarrrrneernnacin runnseranee 35 SPEGIFICATIONS E E E ee AE ET 37 POMOrMAaNnCe ts sis case ri EE TNA he easededs 37 EISCUriCall aeren snee neds en a geet cuetey caddeetiuees 38 Environmental kossor nonen a a o a ON 38 Physical igei ie s n i A ARA E tenet tee 39 APPENDIX PRINCIPLES OF OPERATION secen 41 Oximetry OvervieW sssssessssesseeserererse ceeeeeeaeeeteeeeteeeeeneeee 41 Automatic Calibration 0 ccceecceeeseeeenee eeresenesreesreens 42 Functional Versus Fractional Saturation 00 42 Measured Versus Calculated Saturation 06 43 FIGURES Figure 1 NPB 40 Front Side View sesser ereere 5 Figure 2 NPB 40 Front Panel Display seenen 6 Figure 3 NPB 40 Rear VieW 0 ecccceeesceeeeeseeeeee rierren 6 Figure 4 NPB 40 Top ViCW ecccceseseeeeeeeneee ceseeeeeesaeeeeeeaaes 7 Figure 5 Installing Batteries cc eeeeeeeneeee ceneeeeesneeeeeeaaes 12 Figure 6 Aligning the NPB 40 and Printer seee 25 Figure 7 Single Event Report ccccccccceeeeeeene ceeeeeteneeeeeeees 26 Figure 8 Multiple Event Report 0 eccceessseeeeeeene rererere 27 Figure 9 Oxyhemoglobin Dissociation Curve cceee 43 TABLES Table 1 Nellcor Sensors ccceccceeeceeseeeetenee eeeeeeseneeeseaeeeeeeeenaes 15 iv SAFETY INFORMATION General Safety Information GENERAL SAFETY INFORMATION This section contains important safety information related to general use of
13. en pressed by itself this key functions as the Store Data key lower icon It stores the currently displayed patient data for printing at a later time Pressing the Shift key before pressing the Combo1 key changes the function to that of a Print key upper icon This action sends patient data to an active properly aligned Hewlett Packard printer to generate a printed report Combo 2 key When pressed by itself this key functions as the Display Light key lower icon It turns the display backlight on or off Pressing the Shift key before pressing the Combo 2 key changes the function that of a Beep On Off key upper icon This action silences or adjusts the pulse beep volume see Silencing or Adjusting Beep Volume in the Start Up and Use section of this manual Shift icon lights when the Shift key function is in use Store Data icon lights when the Store Data function is in use While the icon is lit either during data storage or printing the event number is shown on the display C Controls Indicators and Symbols Print icon lights when the Print function is in use Note while printing the monitor does not measure SpO2 The Pulse Search icon lights prior to initial acquisition of a pulse signal and during Pulse Search mode The Low Battery icon flashes when 45 minutes or less battery capacity remains with disposable batteries The icon flashes at least once per second Refer to Battery Operat
14. ent See the appropriate sections of the manual for specific safety information related to these conditions WARNING If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the monitor is functioning correctly INTRODUCTION Intended Use General Operating Principles and Conditions INTENDED USE The Nellcor NPB 40 handheld pulse oximeter is intended for noninvasive spot check measurement of functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate measured by SpO2 sensor The monitor is intended for use on adult pediatric and neonatal patients It can be used in mobile environments when protected from excessive moisture such as direct rainfall Caution The NPB 40 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms WARNING The NPB 40 is not equipped with alarms The monitor is for attended monitoring only and must be used under the direct supervision of a qualified health care provider WARNING Do not use the NPB 40 or Nellcor sensors during magnetic resonance imaging MRI scanning Induced current could potentially cause burns The NPB 40 may affect the MRI image the MRI unit may affect the accuracy of oximetry measurements Caution The NPB 40 may be used during defibrillation but the readings may be inaccurate for a short time The battery operated N
15. epartment or your local Mallinckrodt representative you may be asked to tell the representative the software version number of your NPB 40 The software version appears on the display screen immediately after the power on self test is completed Write the number down and have it available whenever requesting technical assistance RETURNING THE NPB 40 34 Contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative for shipping instructions including a Returned Goods Authorization number Remove the batteries for shipping and unplug the sensor It is not necessary to return the sensor 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 Troubleshooting and Maintenance MAINTENANCE Service WARNING The cover should be removed only by qualified service personnel There are no user service able parts inside The NPB 40 requires no routine service or calibration If service is necessary contact qualified service personnel or your local Mallinckrodt representative Cleaning Caution Do not allow any liquid to come in contact with the NPB 40 its accessories connectors switches or openings in the chassis To clean the NPB 40 dampen a cloth with a commercial nonabrasive cleaner and lightly
16. er see Troubleshooting section for error codes and necessary action that should be taken Start Up and Use 5 Upon successful completion of the POST the NPB 40 sounds a 2 second tone indicating that the monitor has passed the test 6 Once the power on self test is complete and the monitor has displayed its software version refer to discussion Determining Software Version in this section the NPB 40 attempts to detect a valid pulse If a valid pulse is not detected within 30 seconds of turning on the monitor the NPB 40 sounds two triple beeps and then automatically shuts off to conserve battery life If a valid pulse is detected the NPB 40 enters Monitoring Mode Monitoring Mode In Monitoring Mode the NPB 40 is either taking an SpO2 measurement storing event data or printing data that has been stored in its memory While taking an SpO2 measurement the monitor displays SpO2 and pulse rate readings with each pulse beat The constant pitch beep sounds once for each pulse and the Pulse Amplitude indicator visually displays pulse strength at the sensor site Note Verify that indicators icons display information and audible sounds are all operational indicating that the monitor is functioning Each valid keypress should generate an appropriate action If any actions do not seem appropriate do not use the monitor Instead contact Mallinckrodt Technical Services Department or your local Mallinckrodt represe
17. hich encompasses 68 of the population All accuracy specifications are based on testing the subject monitor on healthy adult volunteers in induced hypoxia studies across the specified range Adult accuracy is determined with Oxisensor II D 25 sensors Neonatal accuracy is determined with Oxisensor II N 25 sensors In addition the neonatal accuracy specification is adjusted to take into account the theoretical effect of fetal hemoglobin in neonatal blood on oximetry measurements 37 Specifications Pulse Rate 20 250 bpm 3 bpm Note Pulse Rate accuracy is expressed as 3 bpm across the display range This variation equals one standard deviation 1SD which encompasses 68 of the population ELECTRICAL Instrument Power Requirements 6V supplied by battery power only Patient Isolation No electrical connection to patient inherently insulated Battery Type Four 1 5V alkaline AA size batteries Battery Capacity Typically 19 hours with four new disposable alkaline batteries Note Not all brands of off the shelf alkaline batteries provide the same battery life ENVIRONMENTAL Operating Temperature Instrument 0 to 55 C Sensor Within physiologic range for specified accuracy Transport Storage Temperature boxed 40 to 70 C 15 95 RH 38 Specifications Humidity Operating 15 95 noncondensing Storage unboxed 15 95 noncondensing over temperature range of 20 C to 60 C Altitude Opera
18. if the batteries are removed PRINTING EVENT DATA The NPB 40 has the ability to print event data when used with a Hewlett Packard printer model HP82240B which is available from Mallinckrodt Note Read the entire user s manual for the Hewlett Packard AP82240B printer prior to using the printer with the NPB 40 Preparing the NPB 40 for Printing In order to print event data the monitor and printer must be turned on and the monitor and printer must be aligned as follows 1 Place the printer and monitor on a flat stable surface oriented as shown in Figure 6 24 Start Up and Use 2 5 5 1 cm Figure 6 Aligning the NPB 40 and Printer 2 The windows on the two instruments must be directly aligned as shown Note While the NPB 40 is printing it is not available for patient monitoring After the monitor and printer are ON and aligned properly data that has been stored in the monitor s memory may be printed To do this press the Shift key then press the Store Data Print Combo 1 key Note Do not move the printer or monitor during printing This can result in an incomplete printed report Should you move either device during the printing process enough to disrupt printing allow the print cycle to be completed You may then reposition the monitor and printer and begin the printing process again as long as the monitor has remained ON Event data reports may be printed in one of two formats a
19. ining Software Version Silencing or Adjusting Pulse Beep Volume Turning Display Light Backlight On or Off Storing Event Data Printing Event Data Sensor Disconnect Indicator Battery Operation Disposal of Device Components Performance Considerations BASIC OPERATION WARNING The NPB 40 is a prescription device and is to qualified personnel only WARNING Do not lift the monitor by the sensor cable because the cable could disconnect from the monitor causing the monitor to drop on the patient Caution The NPB 40 is intended only as an adjunct in patient assessment It must be used in conjunction with clinical signs and symptoms Important Prior to using the NPB 40 carefully read this manual accessory directions for use all precautionary information in boldface type and all specifications Before you use the NPB 40 you must verify that the monitor is working properly and is safe to use Proper working condition can be verified by successful completion of the power on self test described in the following steps and by following the instructions contained in Monitoring Mode in this section Note Before using the NPB 40 remove the plastic protective sheet that covers the display This sheet is only on the display to protect it during shipping Leaving it on during monitoring could make it difficult to read displayed measurements 19 Start Up and Use Power On Self Test POST 20 Caution Do not conne
20. inutes of entering Pulse Search Mode the NPB 40 sounds two triple beeps and turns itself off provided no event data has been stored since the monitor was turned on If patient event data is stored the monitor will remain on and after 60 minutes will triple beep at 10 second intervals as a reminder Once a valid pulse is again acquired in this mode the instrument enters Monitoring Mode Start Up and Use DETERMINING SOFTWARE VERSION Immediately following the successful completion of the power on self test the monitor displays the software version contained in the monitor Note This software version number is often needed when calling Mallinckrodt Technical Services Department or your local Mallinckrodt representative for technical assistance After displaying the software version for approximately 3 5 seconds the Pulse Search icon lights indicating that the NPB 4O0 is in operation SILENCING OR ADJUSTING PULSE BEEP VOLUME At start up the pulse beep is ON with the volume set at HIGH By pressing the Shift key and then the Display Light Sound Combo 2 function key you may cycle the NPB 40 pulse beep tone from HIGH volume through OFF LOW volume and then back to HIGH volume While using the NPB 40 do not cover the holes located in the rear of the monitor These allow the audible alert sounds error tones and pulse beep tones to exit the monitor TURNING DISPLAY LIGHT BACKLIGHT ON OR OFF The NPB 40 has a displa
21. ion in the Start Up and Use section for a discussion regarding use of disposable and rechargeable batteries The Sensor Disconnect icon lights when the NPB 40 does not detect the connection of an SpO2 sensor to the monitor DESCRIPTION OF VISUAL INDICATORS AND DISPLAYS The Sp02 display show hemoglobin oxygen saturation level It is updated with each pulse Synchronous with each pulse the monitor beeps If the SpO2 level drops by more than 2 the monitor will emit a double beep tone The Pulse Amplitude indicator is a 10 segment display that shows the relative pulse amplitude As the detected pulse becomes stronger more contiguous segments light with each pulse The digital Pulse Rate display shows the pulse rate in beats per minute It is updated with each pulse Controls Indicators and Symbols DESCRIPTION OF AUDIBLE INDICATORS Following are audible indicators for which there are no accompanying symbols keys or visual indicators WARNING The NPB 40 is not equipped with alarms The monitor is for attended monitoring only and must be used under the direct observation of a qualified health care provider Power Up Self Test pass One 2 second tone No sensor connected at start Error tone dual pitch tone up or sensor disconnected for 3 seconds SpO2 drop of more than 2 1 double beep tone No Pulse detected for 2 triple beeps then NPB 40 30 seconds after power up turns itself off Pulse acquired the
22. mpliance with ISO 10993 1 PERFORMANCE CONSIDERATIONS WARNING Pulse oximetry readings and pulse signal can be affected by certain ambient environmental conditions sensor application errors and certain patient conditions Inaccurate measurements can be caused by e incorrect application of the sensor e placement of the sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line e ambient light e patient movement Loss of pulse signal can occur for the following reasons e the sensor is too tight e a blood pressure cuff is inflated on the same extremity as the one with the sensor attached e there is arterial occlusion proximal to the sensor Use only Nellcor sensors and sensor cables Select an appropriate sensor apply it as directed and observe all warnings and cautions presented in the directions for use accompanying the sensor Clean and remove any substances such as nail polish from the application site Periodically check to see that the sensor remains properly positioned on the patient 16 Nellcor Puritan Bennett Sensors WARNING Tissue damage can be caused by incorrect application or duration of use of an SpO2 sensor Inspect the sensor site as directed in the sensor directions for use 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 inte
23. n lost No 2 triple beeps then NPB 40 pulse detected for 15 minutes turns itself off and event memory is empty Pulse acquired then lost No 1 triple beep every pulse detected for 60 minutes 10 seconds and event memory is not empty Low Battery 1 triple beep tone at 3 minute intervals Impending Dead Battery 2 triple beep tones then NPB 40 turns itself off 10 SETUP Unpacking and Inspection Testing List of Components Monitor Setup UNPACKING AND INSPECTION Notify the carrier if the shipping carton is damaged Unpack the NPB 40 and components If anything is missing or damaged contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative TESTING Before using the NPB 40 in a clinical setting verify that the monitor functions properly by following the instructions in the Start Up and Use section of this manual LIST OF COMPONENTS Nellcor NPB 40 handheld pulse oximeter Alkaline AA size 1 5 V batteries Durasensor oxygen transducer model DS 100A Operator s manual Quick Guide adhesive label See Re Optional Accessories The following items are available from Mallinckrodt for use with this monitor Protective Boot Rain Jacket Carrying Case Hewlett Packard printer model HP82240B Hewlett Packard printer paper 11 Setup MONITOR SETUP Installing the Batteries 1 Pull the battery compartment latch downward toward the bottom of the monitor and
24. ntative In Monitoring Mode if the acquired pulse is lost the monitor enters Pulse Search Mode 21 Start Up and Use Pulse Search Mode 22 During Pulse Search Mode the monitor attempts to detect a pulse from which to take a measurement Note Pulse Search is a normal function of the monitor and entering this mode is not necessarily indicative of a lost patient pulse At Initial Power Up Immediately after the monitor is turned on and the power on self test is completed and the NPB 40 displays its software version number the monitor enters Pulse Search Mode and the Pulse Search icon lights The display reads zeroes while it searches for a valid pulse If a valid pulse is detected within 30 seconds of entering this mode at initial start up the NPB 40 enters Monitoring Mode If a valid pulse is not detected within 30 seconds of entering Pulse Search Mode after start up the monitor sounds two triple beeps and then automatically shuts off After Taking Measurements If a pulse was acquired previously and then lost the NPB 40 enters Pulse Search Mode and the Pulse Search icon lights The display shows the last detected readings while it searches for a valid pulse When it considers the pulse lost it displays zeroes and continues its search If a valid pulse is again detected within 15 minutes of entering Pulse Search the NPB 40 immediately reenters Monitoring Mode If a valid pulse is not detected within 15 m
25. remove the battery access door 2 Install four AA size batteries oriented as shown in Figure 5 Replace the battery access door Note Install the negative end of each battery first compressing the battery terminal spring until the positive terminal clears the positive spring and pressing the battery downward into place To remove the batteries reverse the installation process removing the positive end of each battery first Refer to Battery Operation in the Start Up and Use section of this manual for important information including the types of batteries to be used with the NPB 40 and precautionary information Figure 5 Installing Batteries 12 Setup General WARNING Explosion hazard Do not use the NPB 40 handheld pulse oximeter in the presence of flammable anesthetics WARNING To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient WARNING As with all medical equipment carefully route patient cabling 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 This page intentionally left blank NELLCOR SENSORS Selecting a Sensor Performance Considerations SELECTING A SENSOR WARNING Before use carefully read the sensor directions for use including all warnings cautions and instr
26. rfere with the performance of an SpO2 sensor To prevent interference from ambient light ensure the sensor is properly applied and cover the sensor site with opaque material Note Failure to take this precaution 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 sensor is properly and securely applied e Move the sensor to a less active site e Use an adhesive sensor that tolerates some patient motion e Use a new sensor with fresh adhesive backing If poor perfusion affects performance consider using the Oxisensor R 15 sensor it obtains measurements from the nasal septal anterior ethmoid artery an artery supplied by the internal carotid This sensor may obtain measurements when peripheral perfusion is relatively poor For low peripheral perfusion consider using the Nellcor RS 10 sensor which is applied to the forehead or temple sites that may be spared during peripheral vasoconstriction Note The preceding section pertains to patient and environmental conditions that can be addressed by sensor selection and application For information regarding the impact of other patient and environmental conditions on oximeter performance see Performance Considerations in the Start Up and Use section 17 This page intentionally left blank START UP AND USE Basic Operation Determ
27. s for each monitoring event e Name of the monitor NPB 40 e Notes Line approximately 1 2 inch of space for handwritten notes e Event ID storage record number e SpO2 and the stored SpO2 value on a single line e BPM pulse rate and the stored Pulse Rate value on a single line See Figure 8 for a sample Multiple Event Report Pada a a AA A eama ti man mate a HPB 40 ID 5po2 37 BPH 35 NPB 40 ID z 5po02 97 BPM 74 Figure 8 Multiple Event Report 27 Start Up and Use Printer and Printer Accessories The Hewlett Packard printer model HP82240B the printer AC adapter and thermal printer paper refills are available from Mallinckrodt SENSOR DISCONNECT INDICATOR When the NPB 40 is in Monitoring or Pulse Search Modes and it detects an invalid sensor connection the Sensor Disconnect indicator flashes and the monitor generates an error tone for 3 seconds If a valid sensor connection is not made within 30 seconds the monitor sounds two triple beeps and then turns itself off If a valid sensor connection is made within 30 seconds the monitor begins a new Pulse Search Note In Monitoring Mode if the acquired pulse is lost the monitor enters Pulse Search Mode Important This transition does not generate an audible alert upon loss of pulse BATTERY OPERATION 28 Caution Check the batteries periodically for corrosion Replace batteries if corrosion is present otherwise
28. sensor directions for use The effects of electromagnetic interference on oximetry readings is discussed in the Troubleshooting and Maintenance section of this manual 30 TROUBLESHOOTING AND MAINTENANCE Troubleshooting EMI Interference Obtaining Technical Assistance Returning the NPB 40 Maintenance Periodic Safety Checks TROUBLESHOOTING WARNING If you are uncertain about the accuracy of any measurement check the patient s vital signs by alternate means then make sure the monitor is functioning correctly WARNING The cover should be removed only by qualified service personnel There are no user service able parts inside If you experience a problem while using the NPB 40 and are unable to correct it contact qualified service personnel or Mallinckrodt s representative The NPB 40 service manual which is for use by qualified service personnel provides additional troubleshooting information Following is a list of possible errors and suggestions for correcting them 1 There is no response to the Power On Off key e The batteries may be missing discharged or oriented incorrectly 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 Mallinckrodt representative 31 Troubleshooting and Maintenance 32 3 The Pulse Search indicator is lit for more than 10 seconds Check the
29. 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 someone else Try another sensor or extension cable Perfusion may be too low for the NPB 40 to track the pulse Check the patient Test the instrument on someone else Change the sensor site Try another type of sensor Excessive patient motion may be preventing the NPB 40 from tracking the pulse Keep the patient still if possible Verify that the sensor is securely applied and replace it if necessary Change the sensor site Use a type of sensor that tolerates more patient movement for example an adhesive sensor 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 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 instrument on someone else 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 sen
30. sor is securely applied and replace it if necessary Change the sensor site Use a type of sensor that tolerates more patient movement for example an adhesive sensor Troubleshooting and Maintenance e 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 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 Anumber followed by EEE appears on the display e Record the number and provide that information to qualified service personnel or your local Mallinckrodt representative EMI INTERFERENCE Caution This device has been tested and found to comply with the limits for medical devices to the IEC 601 1 2 1993 EN60601 1 2 1994 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 the health care and home environments for example cellular phones mobile two way radios electrical appliances it is possible that high levels of such interference due to close proximity or strength of a source may result in disr
31. ting 1280 ft to 12 000 ft 390 m to 3 658 m 1060 hPa to 650 hPa Storage 1500 ft to 15 000 ft 457 m to 4 573 m 1070 hPa to 572 hPa PHYSICAL Weight with batteries installed 0 3 kg 11 oz Size 15 75 cm high x 7 5 cm wide x 3 8 cm deep 6 2 in high x 2 95 in wide x 1 5 in deep Equipment Classification IEC 601 1 CSA 601 1 UL 2601 1 Type of Protection Internally Powered Degree of Protection Type BF Enclosure Degree of Protection IPX1 Mode of Operation Continuous 39 This page intentionally left blank APPENDIX PRINCIPLES OF OPERATION Oximetry Overview OXIMETRY OVERVIEW Pulse oximetry is based on two principles that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light i e spectrophotometry and that the volume of arterial blood in tissue and hence light absorption by that blood changes during the pulse i e plethysmography A pulse oximeter determines SpO2 by passing red and infrared light into an arteriolar bed and measuring changes in light absorption during the pulsatile cycle Red and infrared low voltage light emitting diodes LEDs in the oximetry sensor serve as light sources a photodiode 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
32. tional saturation oxygenated hemoglobin expressed as a percentage of the 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 fractional saturation functional saturation x1 100 carboxyhemoglobin methemoglobin Appendix Principles of Operation Measured versus Calculated Saturation When saturation is calculated from a blood gas partial pressure of oxygen PO2 the calculated value may differ from the SpO2 measurement of a pulse oximeter This usually occurs because the calculated saturation was not appropriately corrected for the effects of variables that shift the relationship between PO2 and saturation Figure 9 pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin t pH 199 Temperature Pet mp E E PCO2 at 2 3 DPG a Fetal Hb at yr 9 c f pH 2 50 M t Temperature T 1 t PCO2 3 t 2 3 DPG 72 0 50 100 PO mmHg Figure 9 Oxyhemoglobin Dissociation Curve 43
33. uctions WARNING Do not use a damaged sensor Do not use a sensor with exposed optical components WARNING Use only Nellcor sensors for SpO2 measurements Other sensors may cause improper NPB 40 performance When selecting a sensor consider the patient s weight and activity level the adequacy of perfusion the available sensor sites the need for sterility and the anticipated duration of monitoring For more information refer to Table 1 or contact your local Mallinckrodt representative Table 1 Nelicor Sensors Oxisensor and Oxisensor II oxygen lt 3 or gt 40 kg transducers Sterile single use only 3 20 kg 10 50 kg gt 30 kg gt 50 kg Oxiband oxygen transducers Reusable OXI A N lt 3 or gt 40 kg with disposable nonsterile adhesive OXI P I 3 40 kg Durasensor oxygen transducer DS 100A gt 40 kg Reusable nonsterile Nellcor reflectance oxygen transducer RS 10 gt 40 kg Reusable nonsterile Dura Y multisite oxygen gt 1kg transducer Reusable nonsterile OxiCliq oxygen transducers Sterile 10 to 50 kg single use only lt 3 or gt 40 kg 3 to 20 kg gt 30 kg 15 Nellcor Puritan Bennett Sensors Biocompatibility Testing Biocompatibility testing has been conducted on Nellcor sensors in compliance with ISO 10993 1 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing The sensors have passed the recommended biocompatibility testing and are therefore in co
34. uption of performance of this device 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 monitor may not seem to operate correctly 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 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 source of this disruption and actions taken to eliminate the source 33 Troubleshooting and Maintenance e Turn equipment in the vicinity off and on to isolate the offending equipment e Reorient or relocate the other receiving device e Increase the separation between the interfering equipment and this equipment If assistance is required contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative OBTAINING TECHNICAL ASSISTANCE For technical information and assistance or to order parts or a service manual contact Mallinckrodt Technical Services Department or your local Mallinckrodt representative The service manual includes block diagrams and a parts list required by qualified personnel when servicing the NPB 40 When calling Mallinckrodt Technical Services D
35. wipe the surfaces of the monitor Do not spray or pour liquid on the instrument or accessories Before attempting to clean an SpO2 sensor first refer to the directions for use enclosed with the sensor Each sensor model has cleaning instructions specific to that sensor PERIODIC SAFETY CHECKS The following safety checks should be performed every 24 months by a qualified person who has adequate training knowledge and practical experience to perform these tests e Inspect the equipment for mechanical and functional damage e Inspect the safety relevant labels for legibility e Verify that the device functions properly as described in this operator s manual The data should be recorded in an equipment log If the device is not functioning properly or fails any of the above tests do not attempt to repair the device Please return the device to the manufacturer or to your distributor for any required repairs 35 This page intentionally left blank SPECIFICATIONS Performance Electrical Environmental Physical PERFORMANCE Measurement Range SpO2 0 100 Pulse Rate 20 250 beats per minute bpm Accuracy SpO2 Adults 70 100 2 digits 0 69 unspecified Neonates 70 100 3 digits 0 69 unspecified Note Accuracies are expressed as plus or minus X digits oxygen saturation percentage points between saturations of 70 100 This variation equals plus or minus one standard deviation 1SD w
36. y backlight that may be turned on and off manually To do this press the Display Light Sound Combo 2 function key by itself do not press the Shift key When the display backlight is on it remains on for approximately 10 minutes then automatically shuts off to conserve battery use STORING EVENT DATA The NPB 40 pulse oximeter contains an internal memory that can store 50 patient data records for later printing To activate the Store Data function 1 While in Monitoring Mode press the Store Data key The monitor displays the Store Data icon along with a number that identifies the entry It then copies the current SpO2 and pulse rate into that memory location The Data Storage Display indicating the ID number of the entry remains on the screen for approximately 3 seconds from the time the Store Data key was pressed 23 Start Up and Use 2 When the patient data storage is completed the monitor returns to the mode it was in previously Note When the Store Data key is pressed and there is NO empty event memory location available the monitor displays the last ID number assigned 50 displays the flashing Store Data icon and sounds an error tone for 3 seconds Events are retained in the NPB 40 memory while the monitor remains on and are cleared when the monitor is turned off or powers itself off If they are cleared the events will not be available for later printing Note The instrument will clear all stored data
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