Nellcor OxiMax N-65 Operator'S Manual Download

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Specifications

Max

N-65 Operator’s Manual

123

Confirmation

Volume level

Fixed at 45 dB(A), at

one meter

Pitch (±30 Hz)

700 Hz

On pulse width

(±20 msec)

130 msec

Off Interval (±20 msec)

130 msec

Number of pulses in

burst

Repetition Pause

(±2 sec.)

N/A

Priority

Valid Key Press

Volume level

Fixed at 45 dB(A), at

one meter

Pitch (±30 Hz)

800 Hz

On pulse width

(±20 msec)

10 msec

Off Interval (±20 msec)

10 msec

Number of pulses in

burst

Repetition Pause

(±2 sec.)

N/A

Priority

Audible Indicators (Continued)

Audible

Indicator

Parameter

Value

Summary of Contents for OxiMax N-65

Page 1: ......

Page 2: ...or s Technical Services Department or your local representative Purchase of this instrument confers no express or implied license under any Nellcor Puritan Bennett patent to use the instrument with any sensor that is not manufactured or licensed by Nellcor Puritan Bennett Covered by one or more of the following U S Patents and foreign equivalents 4 802 486 4 869 254 4 928 692 4 934 372 4 960 126 5...

Page 3: ...Symbols 14 Label Symbols 15 Controls 16 Displays and Indicators 19 Audible Indicators 24 Set up the OXIMAX N 65 25 List of Components 27 Connect OXIMAX Sensor to the Monitor 27 Inaccurate Monitor Measurements 28 Battery Operation 31 Battery Power 31 Low Battery Indicator 31 Critical Battery Indication 32 Battery Installation 33 OXIMAX N 65 Operation 35 Introduction 35 Turn On the OXIMAX N 65 36 Di...

Page 4: ...Alarms 54 Discussion 54 Procedure 55 Set Alarm Limits 56 Discussion 56 Procedure 57 Alarm Limit Changed Indicator 61 Record Snap Shot Data 61 Discussion 61 Procedure 62 Print Data 63 Discussion 63 Print Mode 65 After Printing Data 65 Procedure 67 OXIMAX Sensor Event Record 69 Event Records 69 OXIMAX Sensors and Accessories 71 Select an OXIMAX Sensor 71 OXIMAX Sensor Features 76 Biocompatibility Te...

Page 5: ...Codes 93 Corrective Action 95 EMI Electromagnetic Interference 99 Technical Assistance 100 Maintenance 103 Return the OXIMAX N 65 103 Service 104 Periodic Safety Checks 104 Cleaning 105 Menu Structure 107 Set Menus Quick Reference 107 Set Menu Parameters 108 Set Time Date Parameters 110 Principles of Operation 113 Oximetry Overview 113 Automatic Calibration 114 Functional versus Fractional Saturat...

Page 6: ...iv OXIMAX N 65 Operator s Manual Electrical 126 Environmental Conditions 128 Physical Characteristics 129 Compliance 129 Manufacturer s Declaration 130 Index 137 ...

Page 7: ...and time provided by the OXIMAX N 65 handheld pulse oximeter when the sensor event record is recorded by the sensor The accuracy of the date time is dependent on the date time already set in and provided by the OXIMAX N 65 WARNING Explosion hazard Do not use the OXIMAX N 65 in the presence of flammable anesthetics mixture with air oxygen or nitrous oxide WARNING Chemicals from a broken LCD display...

Page 8: ...specific safety information WARNING The use of accessories sensors and cables other than those specified may result in increased emission and or create invalid readings of the OXIMAX N 65 WARNING Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements WARNING Do not silence the audible alarm function or decrease the audibl...

Page 9: ...it and shortly thereafter To avoid shock the caregiver should not hold the OXIMAX N 65 while using a defibrillator on a patient WARNING Disconnect the OXIMAX N 65 and Nellcor OXIMAX sensor from the patient throughout magnetic resonance imaging MRI scanning Induced current could potentially cause burns WARNING To ensure accurate performance and prevent device failure do not subject the OXIMAX N 65 ...

Page 10: ...the patient Cautions Cautions are identified by the CAUTION symbol shown above Cautions alert the user to exercise care necessary for the safe and effective use of the OXIMAX N 65 handheld pulse oximeter Caution All combinations of equipment must be in compliance with IEC Standard 60601 1 1 systems requirements Caution Federal law U S A restricts this device to sale by or on the order of a physici...

Page 11: ...Safety Information OXIMax N 65 Operator s Manual 5 Notes Notes are identified by the Note symbol shown above Notes contain important information that may otherwise be overlooked or missed ...

Page 12: ...Safety Information 6 OXIMax N 65 Operator s Manual ...

Page 13: ...tinuous or spot check monitoring of functional arterial oxygen saturation SpO2 and pulse rate of adult pediatric and neonatal patients in hospital hospital type facilities transport and mobile environments as well as in the home care environment How to Use this Manual All users should read this manual thoroughly More experienced users of the monitor can refer directly to the topics for the informa...

Page 14: ...Introduction 8 OXIMax N 65 Operator s Manual ...

Page 15: ...o l s D i s p l a y s a n d I n d i c a t o r s Front Panel Description This section identifies the symbols controls displays and indicators on the OXIMAX N 65 1 SpO2 area of display 2 Measured SpO2 3 Pulse beats per minute BPM area of display 4 Measured BPM ...

Page 16: ...ndicator 7 Pulse Amplitude indicator Blip bar 8 Time Colon time date field separator 9 Adjust Time mode indicator 10 Adjust Volume mode indicator 11 Set Limit mode indicator 12 BPM Upper Alarm Limit indicator 13 BPM Limit Changed indicator 14 Sensor Off Patient indicator 15 Sensor Disconnected indicator 16 SpO2 Limit Changed indicator ...

Page 17: ... Low Battery indicator 18 Data In Sensor indicator 19 Alarm Volume Adjust indicator 20 Pulse Beep Tone Volume Adjust indicator 21 BPM Lower Alarm Limit indicator 22 Print indicator 23 Interference indicator 24 Pulse Search indicator 25 Data indicator 26 Alarm Silenced indicator ...

Page 18: ... Controls Displays and Indicators 12 OXIMax N 65 Operator s Manual 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 ...

Page 19: ...Indicators OXIMax N 65 Operator s Manual 13 Front Panel Symbols The following two symbols are located on the front panel of the monitor Displays the measured percent of oxygen saturation Displays the measured pulse beats per minute ...

Page 20: ...l Rear Panel Symbols The following symbols are located on the rear panel of the monitor See Instructions for Use Type BF Applied Part Not defibrillator proof Resistant to liquid ingress Rx Prescription only Date of Manufacture European union approval 1 Label 2 Battery Cover ...

Page 21: ...anual 15 Canadian USA certification mark electrical safety Russian regulatory approval Serial number Label Symbols These symbols display on the monitor s labels Keep away from heat Temperature limitation Protect from moisture Fragile Keep upright Humidity limitation ...

Page 22: ...either a valid or invalid key tone See Audible Indicators on page 24 If a tone fails to emit when you press a button contact qualified service personnel The following monitor display shows the buttons described in this section The Alarm Silence button Silences the audible alarms If you press the button when no audible alarm is active alarms during the selected alarm silence duration are silenced I...

Page 23: ... button during normal operation to decrease the pulse beep volume The Data Record Print button Stores the currently shown SpO2 and BPM values snap shot data You can print the stored snap shot data such as a single event report snap shot and or sensor event data by pressing the Data button in print mode The Menu button Press repeatedly during normal operation to display the parameters Parameters yo...

Page 24: ... displays Repeatedly pressing the Menu button displays the following time date parameters you can set Hour Minute Day Month Year After the time date parameters are set you can return to the POST display The Backlight button Press to toggle the backlight ON or OFF The backlight remains on for approximately 10 minutes The Up Arrow button While in menu mode press repeatedly to increase a parameter by...

Page 25: ...turation percentage and pulse rate readings BM are being reported no error conditions exist The Power button Press to toggle the monitor power ON or OFF The Power button has a raised protrusion bump at its center and a gloss surface finish for tactile differentiation from other buttons Displays and Indicators The monitor display as shown below includes a Pulse Amplitude blip bar functional icons c...

Page 26: ... of SpO2 and pulse rate dependent on the measurement conditions Throughout normal measurement conditions the averaging time is six to seven seconds The signal processing algorithm extends the amount of data required beyond seven seconds for measurement conditions in which incoming signal quality is degraded such as low perfusion active patients ambient light electromagnetic interference EMI If the...

Page 27: ...when the SpO2 is outside the alarm limits shows a decimal point after the SpO2 value 98 0 if alarm limits have changed from their power on defaults Pulse Amplitude indicator blip bar Indicates the dynamic pulse amplitude and rate As the detected pulse becomes stronger more bars light with each pulse The reverse is true for weak pulses When setting alarm volume the Pulse Amplitude blip bar reflects...

Page 28: ...ondition at which time the monitor indicates an error condition and shuts down Alarm Silenced indicator Displays when audible alarms have been silenced It flashes when the audible alarms are disabled Interference indicator Lights when the N 65 algorithm detects the incoming signal quality is degraded Degradations can be caused by ambient light electrical noise electrosurgical interference patient ...

Page 29: ...played value is the lower alarm limit for SpO2 or Pulse Rate Data indicator Displays when the monitor is in the store snap shot data or data print mode The indicator flashes when snap shot data prints Print indicator Displays when the monitor is in print mode The indicator flashes when the monitor prints single event snap shot or patient alarm events data which is stored in the sensor Sensor Disco...

Page 30: ...sted Sensor Off Patient indicator Displays when the monitor detects the sensor has come off the patient SNAP SHOT DATA ID indicator An alphanumeric display that shows the number of the current captured patient SpO2 and pulse rate PR values It assigns an ID to the data captured The ID number is shown in the SpO2 area of the display Audible Indicators The monitor generates auditory signals for use a...

Page 31: ...ure 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 OXIMAX N 65 and Nellcor OXIMAX sensor from the patient throughout magnetic resonance imaging MRI scanning Induced current could potentially cause burns WARNING To ensure accurate performance and prevent device failure do not sub...

Page 32: ...on cable because the cable could disconnect from the monitor and the monitor may drop on the patient WARNING Use only the Nellcor extension cable DEC 4 with the OXIMAX N 65 Do not attach any cable that is intended for computer use to the OXIMAX sensor port Do not connect any device other than a Nellcor approved OXIMAX sensor to the OXIMAX sensor connector Do not use the DEC 8 with the monitor ...

Page 33: ...of the manual for specific safety information Safety Information on page 1 OXIMAX Sensor Performance Considerations on page 89 OXIMAX Sensors and Accessories on page 71 Caution Use only Nellcor approved OXIMAX sensors and if needed the DEC 4 extension cable Quantity Item 1 OXIMAX N 65 handheld pulse oximeter 4 Alkaline AA size 1 5 volt batteries 1 Nellcor OXIMAX sensor or sensor assortment pack 1 ...

Page 34: ...ysiological conditions medical procedures or external agents that may interfere with the monitor s ability to detect and display accurate measurements include incorrect application of the OXIMAX sensor placement of the OXIMAX sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line excessive patient activity intravascular dyes such as indocyanine green or methylene...

Page 35: ...r is applied too tightly defibrillation a blood pressure cuff is inflated on the same extremity as the one with the OXIMAX sensor attached there is arterial occlusion proximal to the OXIMAX sensor poor peripheral perfusion loss of pulse cardiac arrest High ambient light sources that can interfere with the performance of an SpO2 OXIMAX sensor are surgical lights especially those with a xenon light ...

Page 36: ...Set up the OXIMAX N 65 30 OXIMax N 65 Operator s Manual ...

Page 37: ...r The OXIMAX N 65 uses batteries to power the monitor A new set of batteries provides between 15 to 40 hours of operation depending on the battery type Low Battery Indicator The Low Battery indicator flashes and a low priority alarm sounds when approximately 15 minutes of operation remains available Replace the batteries See Battery Installation on page 33 ...

Page 38: ...r types of batteries Caution Periodically check the battery for corrosion If the OXIMAX N 65 is to be stored for three months or longer remove the batteries from the monitor before storage Critical Battery Indication When the batteries are critically low the monitor displays an error message Er 521 sounds a high priority alarm shuts down Replace the batteries and restart the monitor See Battery In...

Page 39: ... Manual 33 Battery Installation To install batteries 1 Turn off the power 2 Pull the battery compartment latch downward toward the bottom of the monitor and remove the battery access door 3 Install four AA size batteries as shown in Figure 1 ...

Page 40: ...ss door Figure 1 Battery Installation WARNING Explosion hazard Do not use the OXIMAX N 65 in the presence of flammable anesthetics mixed with air oxygen or nitrous oxide WARNING Dispose of batteries in accordance with local ordinances and regulations 1 Battery compartment latch ...

Page 41: ...k reference information see Set Menu Parameters on page 108 and Set Time Date Parameters on page 110 Parameters remain in effect until the monitor is turned off Table 2 Parameter Ranges and Defaults Parameter Ranges Selections Factory Defaults SpO2 Upper Alarm Limit Lower Alarm Limit plus 1 to 100 100 SpO2 Lower Alarm Limit 20 to Upper Alarm Limit minus 1 85 Pulse Rate Upper Alarm Limit Lower Alar...

Page 42: ... the monitor is turned on POST automatically tests the monitor circuitry and functions Caution During the Power On Self Test POST immediately after power up confirm that all display segments and icons are shown and the monitor speaker sounds a one second tone WARNING If you do not hear the POST pass tone do not use the OXIMAX N 65 Alarm Silence Duration Alarms 30 60 90 120 seconds OFF 30 seconds A...

Page 43: ...es blank all display elements off for one second The software version number shows for 3 seconds as a three digit number in the right number field and two dashes in the left number field The current time of day is shown in 24 hour format Successful completion of POST is announced by a POST pass tone A failed POST is announced by a high priority alarm tone Procedure To turn on the monitor 1 Press t...

Page 44: ...IMAX N 65 Operation 38 OXIMax N 65 Operator s Manual All display numbers and icons show for three seconds The backlight is on while all numbers and icons are shown 2 The display goes blank for one second ...

Page 45: ...t number in the right number field and two dashes in the left number field Note The software version 001 is an example Check the monitor for the software version installed Write down the software version number and have it available prior to requests for technical assistance 4 The current time displays in a 24 hour format ...

Page 46: ...oting on page 93 6 Upon successful completion of POST the monitor sounds a one second tone to indicate it has passed the test WARNING Ensure the speaker is clear of any obstructions and the speaker holes are not covered Failure to do so could result in an inaudible alarm tone Note The POST pass tone also functions as an audible confirmation that the speaker performs properly ...

Page 47: ...ptimal performance allow the monitor to search and lock onto a pulse for approximately 10 seconds When a valid pulse is detected the monitor begins monitoring and displays patient parameters Movement of the blip bar indicates that real time data is displayed Continue to listen for the pulse beep tone as the monitor is used If it does not sound with each pulse it indicates one of the following puls...

Page 48: ...nitor and applied to a patient and loses the pulse signal the monitor displays two dashes and two dashes and displays the Pulse Search icon as shown on the monitor re No OXIMAX Sensor Attached Upon successful completion of POST the monitor sounds a one second tone indicating that it has passed POST ...

Page 49: ...valid sensor Backlight On Off The backlight turns off after approximately 10 seconds With the monitor turned on press the Backlight button to turn the monitor backlight on or off Caution When adjusting any menu parameter the SpO2 and BPM do not display but they continue to record Adjust Pulse Beep Volume Discussion There are two ways to adjust the pulse beep volume during monitoring using the menu...

Page 50: ...ments or decrements as a relative indicator of the current volume Attempted adjustments outside the range generate an invalid key tone The minimum pulse rate volume is none or OFF no blip bar segments shows The maximum pulse rate volume is ten ten segments The Beep Tone Volume Adjust indicator flashes when the pulse beep volume is adjusted to zero Note When the monitor times out in 30 seconds the ...

Page 51: ...eters on page 108 To adjust the pulse beep volume using the menu structure 1 From the main monitoring screen press the Menu button five times until the pulse beep volume level is shown and the monitor sounds 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 ...

Page 52: ...crements or decrements as a relative indicator of the current alarm volume Attempted adjustments outside the range generate an invalid key tone Note When the monitor times out in 30 seconds the parameter is set and the monitor display returns to the normal mode Procedure To adjust the alarm volume WARNING Do not silence the audible alarm function or decrease the audible alarm volume if patient saf...

Page 53: ... main monitor screen press the Menu button six times until the alarm volume screen appears 2 Press the Up Arrow or Down Arrow button to increase or decrease alarm volume 3 Press the Menu button two times to set the alarm level and return to the monitor display screen ...

Page 54: ...conds the parameter is set and the monitor display returns to the normal mode When you make the month entry the monitor checks the day selection to ensure the date is valid If the day selection is not valid for the month selected the menu display returns to the day selection display When you make the year entry the monitor checks the day and month selections to ensure the selections are valid If t...

Page 55: ...the main monitor screen press the Power button to turn the monitor off 2 Press the Power button to turn the monitor on 3 While the monitor is in the POST mode press the Menu button until the set hours display shows The hours display 13 will flash 4 Press the Up Arrow button or the Down Arrow button until the desired hours appear ...

Page 56: ...Menu button to set the hours and show the minutes set display The minutes display 45 flashes 6 Press the Up Arrow button or the Down Arrow button until the desired minutes appear 7 Press the Menu button to set the minutes and show the day set display The day 29 flashes ...

Page 57: ...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 show the month set display The month 7 flashes 10 Press the Up Arrow button or the Down Arrow button until the desired month is shown ...

Page 58: ...11 Press the Menu button to set the month and display the year set display The year 2004 will flash 12 Press the Up Arrow button or the Down Arrow button until the desired year is shown 13 Press the Menu button to set the year and return to normal operation ...

Page 59: ...alarm cannot be silenced Note When the monitor times out in 30 seconds the parameter is set and the monitor returns to the normal mode Procedure To set the alarm silence duration 1 From the main monitor screen press the Alarm Silence button until SEC or OFF appears on the pulse rate area of the display Then release the button WARNING Do not silence the audible alarm function or decrease the audibl...

Page 60: ...Down Arrow button until the desired alarm silence duration is shown 3 Press the Alarm Silence button to set the shown alarm silence duration and return to normal operation Disable Audible Alarms Discussion When the alarm silence duration is set to OFF the monitor produces no audible alarms The Alarm Silence indicator flashes while the alarm silence duration is set to OFF ...

Page 61: ...ode Procedure To disable audible alarms WARNING Do not silence the audible alarm function or decrease the audible alarm volume if patient safety could be compromised 1 From the main monitor screen press the Alarm Silence button until OFF displays in the pulse rate area of the monitor Release the button Available Alarm silence durations are OFF 30 60 90 and 120 seconds ...

Page 62: ...on is set to OFF Set Alarm Limits Discussion The Alarm Limit display allows you to adjust the upper and lower saturation and pulse rate limits Press and hold the Up Arrow or Down Arrow buttons to scroll rapidly through the limit values The Alarm Limit Changed indicator displays anytime an alarm limit changes See Alarm Limit Changed Indicator on page 61 Note When the monitor times out in 30 seconds...

Page 63: ...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 SpO2 low alarm limit cannot be set equal to or higher than the SpO2 upper alarm limit 2 Press and hold the Up Arrow or Down Arrow buttons to scroll rapidly through the values 3 Press the Menu button to set the limit value The SpO2 upper alarm limit displays ...

Page 64: ...O2 low alarm limit 4 Press the Up Arrow or Down Arrow buttons to increase or decrease the upper alarm limit 5 Press the Menu button to set the limits value The BPM lower alarm limit displays The pulse rate low alarm limit range is 30 to 249 The upper value of the 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 se...

Page 65: ...ess the Menu button to set the limit value The BPM upper alarm limit displays The pulse rate upper alarm limit range is 31 to 250 The lower value of the 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 ...

Page 66: ... pulse rate limit 9 Press the Menu button to confirm the alarm limit settings 10 Press the Menu button until you return to normal operation Note Limit changes are in effect only as long as the monitor remains on When it is turned off the default limits are restored When the monitor is turned on the default limits will be in effect ...

Page 67: ...hanges Record Snap Shot Data Discussion The monitor contains an internal memory that can store 50 patient data records snap shots You can print data records Data are retained in the monitor memory while it remains on and cleared when it is turned off or powers itself off If the data are cleared they are not available to print Replacement of the monitor batteries clears patient data The Data indica...

Page 68: ...data displays The number 1 in the SpO2 field is the identification ID number of captured snap shots When you press the Data button and there is no empty event memory location available the monitor displays the last ID number assigned 50 the Data icon continues to flash at the medium priority rate an invalid key tone sounds the monitor returns to the normal mode after approximately three seconds ...

Page 69: ...h the OXIMAX N 65 Note Read the entire user s manual for the Citizen PD 22T portable printer prior to operating the printer with the monitor The monitor must be linked via infrared IR to a compatible printer to print Note The monitor remains on if there are patient alarm event data stored Print data contains one or more of the following a summary report if currently connected to a patient The summ...

Page 70: ...OXIMax N 65 Operator s Manual sensor event data patient alarm event data if a sensor with patient event data is connected to the monitor The monitor prints all available data as shown in Figure 2 Figure 2 Combined Printed Data ...

Page 71: ...e normal mode The Menu button is disabled during print mode If there is no communication with the printer for 30 seconds print mode is aborted and the display returns to normal mode After Printing Data The summary report data is purged after it is printed or on time out due to printer communication failure Snap shot or sensor event data is not purged after printing or time out due to printer commu...

Page 72: ...w If no data are stored neither icon shows and the display is blank The monitor and sensor does not differentiate between patients Use caution when reviewing the report as the list of snap shots may contain data from more than one patient Also if a 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...

Page 73: ...To print data 1 Align the printer and the monitor 2 Orient the printer and monitor as shown in Figure 3 The alignment of the infrared ports of the printer and the monitor must not exceed two feet and must not be closer than six inches 15 cm Figure 3 Printer Alignment ...

Page 74: ...ax N 65 Operator s Manual 3 From the main monitor screen press the Menu button seven times The print display is shown 4 Press the Data button to start printing During printing the stored snap shot number displays for each snap shot ...

Page 75: ... the patient on the sensor s memory chip for quick assessment at every point of care where OXIMAX monitors are used The patient alarm data are stored recorded with the monitor 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 enabled monitor to which the patient is connected when the patient moves to a new poin...

Page 76: ...ds 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 Data In Sensor indicator displays when the sensor contains patient alarm events The Data In Sensor indicator flashes when the sensory memory is full Recording and viewing of OXIMAX sensor event data is only avail...

Page 77: ...ING Failure to cover the OXIMAX sensor site with opaque material in high ambient light conditions may result in inaccurate measurements WARNING Before use carefully read the applicable OXIMAX sensor Directions For Use including all warnings cautions and instructions WARNING Do not use a damaged OXIMAX sensor or extension cable Do not use an OXIMAX sensor with exposed optical components WARNING Use...

Page 78: ...MAX sensor site periodically as directed in the OXIMAX 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 OXIMAX sensor as this may damage the sensor WARNING Do not lift the monitor by the OXIMAX sensor or extension cable because the...

Page 79: ...th For additional information on monitor measurements see Inaccurate Monitor Measurements on page 28 For a complete current list of all OXIMAX sensors applicable to the OXIMAX N 65 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 OXIMAX sensor consider the following patient weight and activ...

Page 80: ...care nonadhesive sensor single patient use preterm infant SC PR 1 5 kg 3 3 lbs OXIMAX Softcare nonadhesive sensor single patient use neonate SC NEO 1 5 kg to 5 kg 3 3 to 11 lbs OXIMAX Softcare nonadhesive sensor single patient use adult SC A 40 kg 88 lbs OXIMAX adhesive sensor single patient use adult MAX A 30 kg 66 lbs OXIMAX adhesive sensor single patient use adult longer cable 36 inches 91 44 c...

Page 81: ...esive sensor single patient use pediatric reusable cable OxiCliq P 10 to 50 kg 22 to 110 lbs OXIMAX OxiCliq adhesive sensor single patient use infant reusable cable OxiCliq I 3 kg to 20 kg 6 6 to 44 lbs OXIMAX Durasensor finger clip sensor reusable adult DS 100A 40 kg 88 lbs OXIMAX Oxiband sensor reusable neonatal adult OXI A N 3 kg or 40kg 6 6 lbs or 88 lbs OXIMAX Oxiband sensor reusable pediatri...

Page 82: ... D YS 1 kg 2 2 lbs For use with the Dura Y sensor Ear clip Reusable nonsterile D YSE 30 kg 66 lbs Pedi CheckTM pediatric spot check clip Reusable nonsterile D YSPD 3 kg to 40 kg 6 6 lbs to 88 lbs Table 3 Nellcor Oximetry Sensor Models and Patient Weights Continued OXIMAX Sensor Model Patient Size greater than less than Table 4 OXIMAX Sensor Features Feature Adhesive Sensors Recycled Sensors Reusab...

Page 83: ...1 Evaluation and Testing The OXIMAX sensors have passed the recommended biocompatibility testing and are therefore in compliance with ISO 10993 1 Optional Accessories The optional accessories offered with the monitor are rubber boot with clip page 78 functional thermoformed holster page 79 carrying case page 80 water resistant jacket page 81 printer page 82 thermal paper page 83 DEC 4 extension ca...

Page 84: ...OXIMAX Sensors and Accessories 78 OXIMax N 65 Operator s Manual Rubber Boot With Clip This accessory protects the monitor Figure 4 Rubber Boot with Clip 1 Front view 2 Rear view ...

Page 85: ...OXIMAX Sensors and Accessories OXIMax N 65 Operator s Manual 79 Functional Thermoformed Holster This accessory protects the monitor Figure 5 Functional Thermoformed Holster 1 Front view 2 Rear view ...

Page 86: ...Manual Carrying Case The Nylon carrying case is equipped with compartments for the monitor Operator s manual compact disk containing all manuals sensors and a carrying strap that is adjustable from 71 cm to 135 cm 28 inches to 53 inches Figure 6 Carrying Case ...

Page 87: ...essories OXIMax N 65 Operator s Manual 81 Water Resistant Jacket The water resistant jacket is made of clear plastic to facilitate use of the monitor in inclement weather or similar conditions Figure 7 Water Resistant Jacket ...

Page 88: ...ual Infrared Printer The Citizen PD 22T portable printer is used to print selected data from the monitor The monitor uses the printer IrDA infrared interface Refer to the User s Manual supplied with the printer for details on the PD 22T printer Figure 8 Printer ...

Page 89: ...ssories OXIMax N 65 Operator s Manual 83 Thermal Paper The thermal paper is for the Citizen PD 22T infrared printer Refer to the User s Manual supplied with the printer for details on the thermal paper Figure 9 Thermal Paper ...

Page 90: ...s 84 OXIMax N 65 Operator s Manual DEC 4 Extension Cable The DEC 4 extension cable provides 1 2 m 4 ft of cable extension between the monitor and the sensor Figure 10 DEC 4 Extension Cable 1 DEC 4 extension cable 2 Sensor connector ...

Page 91: ...s OXIMax N 65 Operator s Manual 85 Transport Boot This accessory is used in the transport environment for compliance with ISO 9919 outside of a hospital such as ambulance transport Figure 11 Transport Boot 1 Front view 2 Rear view ...

Page 92: ...OXIMAX Sensors and Accessories 86 OXIMax N 65 Operator s Manual ...

Page 93: ...on such as Safety Information on page 1 and OXIMAX Sensors and Accessories on page 71 Performance Verification The performance of the OXIMAX N 65 is verified by following the procedures outlined in the Performance Verification section of the monitor service manual Qualified service personnel should perform these procedures before using the monitor for the first time in a clinical setting OXIMAX N ...

Page 94: ...oximetry is recommended Anemia Anemia causes decreased arterial oxygen content Although SpO2 readings may appear normal an anemic patient may be hypoxic Correcting anemia can improve arterial oxygen content The monitor may fail to provide an SpO2 if hemoglobin levels fall below 5 gm dl Saturation The monitor displays saturation levels between 1 and 100 Pulse Rates The monitor displays pulse rates ...

Page 95: ...se 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 OXIMAX sensor Inaccurate measurements can be caused by incorrect application of the OXIMAX sensor placement of the OXIMAX sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line excessive patient activity intravas...

Page 96: ...t To use the OXIMAX sensor Select an appropriate OXIMAX sensor Apply the sensor as directed and observe all warnings and cautions presented in the Directions For Use accompanying the OXIMAX sensor Clean and remove any substances such as nail polish from the application site Periodically check to ensure that the OXIMAX sensor remains properly positioned on the patient High ambient light sources tha...

Page 97: ... sensor is properly and securely applied move the OXIMAX sensor to another site use an adhesive OXIMAX sensor use a new OXIMAX sensor with fresh adhesive backing keep the patient still if possible If interference due to poor perfusion presents a problem consider using the MAX R OXIMAX sensor or the MAX FAST OXIMAX sensor The MAX R OXIMAX sensor obtains measurements from the nasal septal anterior e...

Page 98: ...Performance Considerations 92 OXIMax N 65 Operator s Manual ...

Page 99: ... functioning correctly WARNING There are no user serviceable parts inside the OXIMAX N 65 The cover should only be removed by qualified service personnel Caution Do not spray pour or spill any liquid on the OXIMAX N 65 its accessories connectors switches or openings in the enclosure as this may damage the monitor Error Codes When the monitor detects an error condition it may display Er followed by...

Page 100: ...rn the monitor off Wait 10 seconds and turn the monitor on If the error appears follow the action s listed in Table 5 Table 5 Error Codes Error Code 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 monitor 2 Set the time and date 3 Notify service personn...

Page 101: ...service manual is available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html 277 Check replace sensor extension cable 280 Check replace sensor extension cable 282 Check replace sensor extension cable 521 Replace batteries 522 Replace batteries 523 1 Restart the monitor 2 Set the time and date 3 Notify service personnel 525 1 Restart the monitor 2 Notify s...

Page 102: ... 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 monitor contact qualified service personnel or your local Nellcor Representative ...

Page 103: ...ient Test the monitor on yourself Change the sensor site Try another sensor Interference due to patient activity may be preventing the monitor 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 The sensor may be too tight there may be interference due to ambient light or the sensor may be on an ex...

Page 104: ... securely applied and replace it if necessary Change the sensor site The sensor may be too tight there may be interference due to ambient light or the sensor may be on an extremity with a blood pressure cuff arterial catheter or intravascular line Reposition sensor as necessary Electromagnetic interference may be preventing the monitor from tracking the pulse Remove the source of interference 5 Er...

Page 105: ...r sources of electrical noise in health care environments 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 Examples of noise sources in healthcare environments that could cause electromagnetic interference are electrosurgical units cellular phones mobile two way radios electrical appliances hi...

Page 106: ... equipment and this equipment The monitor generates uses and can radiate radio frequency energy If it is not installed and used in accordance with these instructions the monitor may cause harmful interference with other devices in the vicinity Technical Assistance For technical information and assistance or to order parts or a service manual contact Nellcor s Technical Service Department at 1 800 ...

Page 107: ...play each time the it successfully completes the power on self test Write the number down so it is available when you request technical assistance This manual and the OXIMAX N 65 Service Manual are available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html ...

Page 108: ...Troubleshooting 102 OXIMax N 65 Operator s Manual ...

Page 109: ... or recycling of the batteries and OXIMAX N 65 components or end of life of the monitor Caution The OXIMAX N 65 will not operate with dead batteries Install new batteries Return the OXIMAX N 65 Contact Nellcor s Technical Service Department at 1 800 635 5267 for shipping instructions including a Returned Goods Authorization RGA number Unless otherwise instructed by Nellcor s Technical Service Depa...

Page 110: ...t provides proof of delivery Service WARNING There are no user serviceable parts inside the OXIMAX N 65 Only qualified service personnel should remove the cover The monitor 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 performed every 24 months inspect th...

Page 111: ...surface clean the monitor use a soft cloth dampened with either a commercial nonabrasive cleaner or a solution of 70 alcohol in water lightly wipe the surfaces of the monitor To disinfect the monitor use a soft cloth saturated with a solution of 10 chlorine bleach in tap water To clean and disinfect an SpO2 OXIMAX reusable sensor read the directions for use enclosed with the OXIMAX sensor Each OXI...

Page 112: ...Maintenance 106 OXIMAX N 65 Operator s Manual ...

Page 113: ...ion on how to set monitor parameters and limits using the menu structure See Set Menu Parameters on page 108 to set the following parameters high and low SpO2 limits high and low BPM limits alarm volume pulse beep volume data printing See Set Time Date Parameters on page 110 to set the following parameters Hour Minute Day Month Year ...

Page 114: ...o display the parameters to set Use the Up Arrow button or Down Arrow button to adjust the parameter limit Press the Menu button to return to the default monitoring display Table 6 Menu Structure of Presses Parameter Press Function 1 SpO2 Low Limit Adjust limit 2 SpO2 High Limit Adjust limit 3 BPM Low Limit Adjust limit 4 BPM High Limit Adjust limit ...

Page 115: ... Pulse Beep Volume Adjust volume Indications on blip bar 6 Alarm Volume Adjust volume Indications on blip bar 7 Print Data Print summary and or stored snap shot and sensor event data Table 6 Menu Structure Continued of Presses Parameter Press Function ...

Page 116: ...the POST display When the month entry is made the monitor checks the day selection to see if it is valid If the 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 monitor checks the day and month selections to see if they are valid If the day or month selection is not valid for the year selected the menu display r...

Page 117: ... s Manual 111 Table 7 Time Set Menu of Presses Parameter Press Function The Menu button must be pressed during the POST 1 Hour Adjust 1 to 23 2 Minute Adjust 1 to 59 3 Day Adjust 1 to 31 4 Month Adjust 1 to 12 5 Year Adjust 2003 to 2099 ...

Page 118: ...Menu Structure 112 OXIMAX N 65 Operator s Manual ...

Page 119: ...bs 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 OXIMAX sensor excessive ambient light can interfere with this measurement For additional information about ambient conditions OXIMAX sensor application and patient conditions see OXIMAX N ...

Page 120: ...rial 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 nonp...

Page 121: ...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 t...

Page 122: ...or All OXIMAX sensors contain a memory chip carrying information about the OXIMAX sensor which the oximeter needs for correct operation including the OXIMAX sensor s calibration data model type troubleshooting codes and error detection data When an OXIMAX sensor is connected to the monitor the pulse oximeter first reads the information in the OXIMAX sensor memory chip checks it to make sure that t...

Page 123: ...erifying that the pulse oximeter sensor cabling and monitor are performing as designed they are incapable of providing the data required to properly evaluate the accuracy of SpO2 measurements Fully evaluating the accuracy of the SpO2 measurements requires at minimum accommodating the wavelength characteristics of the sensor and reproducing the complex optical interaction of the sensor and the pati...

Page 124: ...fect use of the simulator for verifying system functionality displayed SpO2 measurement values may differ from the setting of the test device For a properly functioning monitor this difference will be reproducible over time and from monitor to monitor within the performance specifications of the test device ...

Page 125: ...pO2 1 to 100 Pulse Rate 20 beats per minute bpm to 250 bpm Perfusion Range 0 03 to 20 Accuracy Tolerance Saturation Adult1 70 to 100 2 digits Neonate 70 to 100 3 digits Low Perfusion2 70 to 100 2 digits Pulse Rate Adult and Neonate1 20 to 250 bpm 3 digits Low Perfusion 2 20 to 250 bpm 3 digits ...

Page 126: ...rsion of the Sensor Accuracy Grid is available on the Internet at http www mallinckrodt com respiratory resp Serv_Supp ProductManuals html 2 Reading accuracy in the presence of low perfusion detected IR pulse modulation amplitude 1 5 was validated using signals supplied by a patient simulator SpO2 and pulse rate values were varied across the monitoring range over a range of weak signal conditions ...

Page 127: ...meter Pitch 30 Hz 752 Hz On pulse width 20 msec 500 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 1 Beep Volume setting Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 1500 Hz On pulse width 20 msec 500 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 2 ...

Page 128: ...Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 3 Invalid Key Press Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 200 Hz On pulse width 20 msec 50 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 4 Audible Indicators Continued Audible Indicator Parameter Value ...

Page 129: ...f Interval 20 msec 130 msec Number of pulses in burst 3 Repetition Pause 2 sec N A Priority 5 Valid Key Press Volume level Fixed at 45 dB A at one meter Pitch 30 Hz 800 Hz On pulse width 20 msec 10 msec Off Interval 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 6 Audible Indicators Continued Audible Indicator Parameter Value ...

Page 130: ...l 20 msec 10 msec Number of pulses in burst 1 Repetition Pause 2 sec N A Priority 7 Alarm Silence Reminder Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 500 Hz On pulse width 20 msec 130 msec Off Interval 20 msec 130 msec Number of pulses in burst 3 Repetition Pause 2 sec 179 27 sec Priority 8 Audible Indicators Continued Audible Indicator Parameter Value ...

Page 131: ...Interval 20 msec 80 msec Number of pulses in burst 1 Repetition Pause 2 sec 0 sec Priority 9 Medium Priority Alarm Volume level Adjustable 42 to 52 dB A at one meter Pitch 30 Hz 752 Hz On pulse width 20 msec 400 msec Off Interval 20 msec 300 msec Number of pulses in burst 1 Repetition Pause 2 sec 0 sec Priority 10 Audible Indicators Continued Audible Indicator Parameter Value ...

Page 132: ...30 Hz 500 Hz On pulse width 20 msec 400 msec Off Interval 20 msec 3200 msec Number of pulses in burst 1 Repetition Pause 2 sec 0 sec Priority 11 Audible Indicators Continued Audible Indicator Parameter Value Batteries Type Voltage 4 AA alkaline 6 Volts DC as per 4 AA batteries Battery life is typically Alkaline 15 hours Lithium 40 hours ...

Page 133: ...icians such as those performing photodynamic therapy Note Sensor LED light emissions fall within Class 1 level according to IEC 60825 1 2001 No special safety precautions are required OXIMAX 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 OXIM...

Page 134: ...Atmospheric Pressure 70 kPa to 106 kPa 20 6 in Hg to 31 3 in Hg Relative Humidity 15 to 95 non condensing Transport and Storage not in shipping container Temperature 20 ºC to 60 ºC 4 ºF to 140 ºF Altitude 390 m to 5 574 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 Temper...

Page 135: ...ith Equipment classification Safety Standards EN 60601 1 1990 A1 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 Operatio...

Page 136: ...es are controlled The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the monitor as recommended below according to the maximum output of the communications equipment Pulse oximeters EN 865 and ISO 9919 with Transport Boot Part number 10007434 Operation during vi...

Page 137: ...n Meters 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 ...

Page 138: ... 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...

Page 139: ...lectromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The OXIMAX N 65 uses RF energy only for its internal function Therefore the RF emissions are very low and not likely to cause interference in nearby electronic equipment RF emissions CISPR 11 Class B The OXIMAX N 65 is suitable for use in establishments including diagnostic establishments and those directly connected to the public l...

Page 140: ...scharge ESD IEC 61000 4 2 6 kV contact 8 kV air Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV power supply lines 1 kV for input output lines Complies Main power should be that of a typical commercial or hospital environment Power Frequency 50 60 Hz ...

Page 141: ...recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 Vrms Recommended Separation Distance 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 80 MHz to 800 MHz Field strengt...

Page 142: ...and mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically 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 OXIMAX N 65 is used exceeds the applicable RF compliance level above the monitor should be observed to verify ...

Page 143: ... limit display 56 alarm limits setting 56 alarm silence duration 53 alarm silence indicator 22 alarm volume 109 adjusting 46 anemia 88 audible alarms disable 54 audible indicator 24 121 B backlight 43 battery critical battery indication 32 installation 33 low battery indicator 31 battery operation 31 biocompatibility testing 77 bpm high limit 108 bpm low limit 108 ...

Page 144: ... silence 16 backlight 18 data record print 17 down arrow 17 18 menu 17 power 19 up arrow 18 D dashes 43 day 111 DEC 4 extension cable 84 disable audio alarms 54 display 9 19 SpO2 21 display update interval 120 dysfunctional hemoglobins 88 E electromagnetic interference 99 error codes 93 event records 69 explosion hazard 1 extension cable DEC 4 84 F fractional saturation 115 ...

Page 145: ...or alarm silenced 22 interference 22 low battery 22 pulse amplitude 21 indicators 9 19 infrared printer 82 intended use 7 introduction 7 L label symbols 15 list of components 27 low battery indicator 22 31 M manufacturer s declaration 130 measured saturation 115 measurements inaccurate 28 menu set time and date 110 menu quick reference 107 menu structure 107 minute 111 monitor ...

Page 146: ... 128 relative humidity 128 temperature 128 optional accessories 77 OXIMAX N 65 measurement range 119 returning 103 OXIMAX technology 116 oximetry overview 113 P paper 83 parameter ranges 35 performance considerations pulse oximeter 87 sensor 89 performance verification 87 power on self test POST 36 print after printing data 65 data 63 mode 65 print data 109 printer 82 pulse beep volume 109 ...

Page 147: ...rning the monitor 103 rubber boot with clip 78 S safety checks 104 safety information 1 saturation calculated 115 fractional 115 functional 115 measured 115 selecting a sensor 73 sensor features 76 performance considerations 89 sensor event record 70 sensor models and patient weights 74 service 104 set alarm limits 56 alarm silence duration 53 date 48 time 48 set up the OXIMAX N 65 25 snap shot da...

Page 148: ...re 14 decimal points 20 European union approval 14 fragile 15 front panel 13 keep away from heat 15 keep upright 15 label 15 protect from moisture 15 rear panel 14 resistant to liquid ingress 14 Russian regulatory approval 15 see instructions for use 14 serial number 15 temperature limitation 15 type BF applied part 14 T technical assistance 100 thermal paper 83 time set menu 111 transport altitud...

Page 149: ... s Manual 143 temperature 128 troubleshooting 93 help 96 turning on the OXIMAX N 65 36 V verification performance 87 volume adjusting alarm 46 pulse beep 43 W warning 1 water resistant jacket 81 wavelength sensor 127 Y year 111 ...

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Page 152: ...ivision 4280 Hacienda Drive Pleasanton CA 94588 U S A Telephone Toll Free 1 800 635 5267 Authorized Representative Tyco Healthcare UK LTD 154 Fareham Road Gosport PO13 0AS U K 2006 Nellcor Puritan Bennett Inc All rights reserved Rx ONLY 10006537B_0106 ...

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