McKesson LUMEON 3069 User manual

PSS World Medical, Inc.
4345 Southpoint Blvd.
Jacksonville, FL 32216
Select Medical Products
Artwork Template
Doc. # T-GS-003
Rev. 1
Eective Date: 10-08-2007
Author: Meghan Little
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PMS 110Yellow Meghan Little 3069_Masterpage
Tympanic Thermometers
1:1 Proportion,As Provided
Final
Final Draft
09-03-09
PMS 110Yellow, K
INFRARED TYMPANIC
ELECTRONIC THERMOMETER
OPERATION MANUAL
FOR USE WITH REORDER # 3069
Comments or Questions about Lumeon Products? 800-777-4908
Manufactured for PSS World Medical, Inc.
4345 Southpoint Blvd., Jacksonville, FL 32216
Made in the USA • www.myselectonline.com
# WN27183473
ºF
C
º

Table of Contents
Page
Section I — Introduction .......................................................................................................................1
Initial Set Up............................................................................................................................................. 1
Section II — General Information..........................................................................................................1
Features .................................................................................................................................................. 1
Section III — Important Precautions .....................................................................................................1
Section IV — Icon Identification............................................................................................................2
Section V — Instructions for Use ..........................................................................................................3
Peak Select System™.............................................................................................................................. 3
Equivalence Modes................................................................................................................................... 3
Probe Covers ........................................................................................................................................... 4
Temperature Measurement ....................................................................................................................... 4
Temperature Recall .................................................................................................................................. 5
Temperature Display - Toggle .................................................................................................................... 5
Sleep Mode.............................................................................................................................................. 5
Pulse Timer Mode..................................................................................................................................... 6
Thermometer Display Icons and Alarms ..................................................................................................... 6
Biotech Mode........................................................................................................................................... 7
Section VI — Preventative Maintenance ...............................................................................................9
Section VII — Cleaning..........................................................................................................................9
Section VIII — Battery Replacement .....................................................................................................9
Section IX — Mounting Instructions....................................................................................................10
Section X — Troubleshooting..............................................................................................................10
Section XI — Specifications................................................................................................................10
Section XII — Customer Service .........................................................................................................12
Section XIII — Warranty ......................................................................................................................12
PSS World Medical, Inc.
4345 Southpoint Blvd.
Jacksonville, FL 32216
Select Medical Products
Artwork Template
Doc. # T-GS-003
Rev.1 Author: Meghan Little

1
Infrared Tympanic Electronic Thermometer
Section I — Introduction
This operator’s manual was prepared for the operator of the Infrared Tympanic Electronic Thermometer. This
manual contains instructions for use, precautions, and available maintenance and service information. To achieve
satisfactory results, the operator must read this manual thoroughly before attempting to use the thermometer.
Initial Set Up
•UnpacktheInfraredTympanicElectronicThermometerandexamineitforstructuralintegrity.
•If using the wall or cart mount options (sold separately) for the base unit, consult the installation sheet provided with the
respective system.
•Whenfirstused,theInfraredTympanicElectronicThermometerwillshowthefactorypresetsettings:earmode
(EAR) and the Celsius scale (°C).
Section II — General Information
The Infrared Tympanic Electronic Thermometer is a fast, accurate, and convenient clinical instrument for
measuring patient temperatures. The Infrared Tympanic Electronic Thermometer is an ear canal thermometer
withmeasurementsiteequivalencemodesincludingoral,axillary,core,andrectalequivalenttemperatures.The
equivalencemodesareexplainedfurtherinSectionV,InstructionsforUse.
Features
•VeryfasttemperatureacquisitionthatmeetsCENandASTMstandards-seeSectionXI.
•PeakSelectSystem™
•Temperaturemeasurementrangeof33.0°Cto42.0°C(91.4°Fto107.6°F).
•Oncetemperaturehasbeenacquired,the°C/°Fbuttonalternatesthedisplayedtemperaturebetween°Cand°F.
•Audibleandvisualindicationofcompletedtemperatureacquisition.
•Disposablesingleuseprobecoversaidinthepreventionofacrosscontaminationofinfectiousdiseases.
•Lowanddeadbatteryindicators.
•“Sleep”modestoresthelasttemperatureandconservesbatterylife.
•15,30,45,and60secondpulsetimerfunctions.
•Thethermometerhousingcanbecleanedwithcommoncleaningagents.SeeSectionVII,Cleaningforinstructions.
•Baseunitprotectsthethermometertipandstoresprobecoversforeasyaccess.
•EasytoreadLCDdisplaywithicons.
•Unitisdesignedforambidextroususe.
•Improvedprobedesigntoalloweaseofuseonthepediatricpopulation.
Section III — Important Precautions
•Thethermometerisaprecisionopticalinstrument.Forreliableoperation,handlecarefullyanddonotdrop.
•Readtheoperator’smanualthoroughlybeforeusingtheInfraredTympanicElectronicThermometer.
•Priortouse,ensurethattheprobetipiscleanandclearofanymaterial.Ifthethermometertipbecomessoiled,
gentlycleanwithalenswipeorlintfreeswab.Thetipshouldappearshinyandfreeoffingerprintsand/ordebris.

2
Infrared Tympanic Electronic Thermometer
•Alwaysinstallanewprobecoverpriortotakingatemperature.Theprobecovermembraneshouldbesmooth
with no holes, tears, or wrinkles.
•ThethermometerwasdesignedtobeusedonlywithInfraredTympanicElectronicThermometerprobecovers.
UseofprobecoversmanufacturedbyanycompanyotherthanLumeon TM may result in erroneous readings.
•Ensure that the probe tip seals the ear canal prior to taking a temperature. Failing to seal the ear canal will result in a
loss of accuracy.
•Whennotinuse,theInfraredTympanicElectronicThermometershouldbeplacedinthethermometerbaseunit.
•TheInfraredTympanicElectronicThermometershouldnotbeusedonpatientswitheardrainage,blood,
cerebrospinalfluid,vernix,earwaxplugs,orforeignbodiesintheearcanal.
•Patientswithremovablehearingaidsshouldremovethedeviceatleast10minutespriortoeartemperature
assessment. Implanted devices generally do not affect ear temperature.
•Pressureequalization(PE)ortympanostomytubeswillnotadverselyaffectaccuracy.Forpatientcomfort,waitone
week after surgery before using Infrared Tympanic Electronic Thermometer.
•Whenassessingpatienttemperaturesduringcoldweatherconditions,allowthepatienttoequilibratetoroom
temperature before use.
•Excessiveeardrumscarringmaycauseloweredtemperaturereadings.
•Undernormalconditions,earwaxdoesnotaffectaccuracy.However,cerumenplugsorimpactionscontaining
debris can lower the temperature measurement by several tenths of a degree.
•Alwayswaitatleasttwominutesbeforetakinganothermeasurementinthesameear.
•Usedprobecoversmustbetreatedasinfectiousbiologicalwasteanddisposedofinaccordancewithcurrent
medical practices and local regulations.
•Lithiumoralkalinebatteriesmustbedisposedofinaccordancewithlocalenvironmentalandinstitutionalpolicies.
•Expiredoroldequipmentmustbedisposedofinaccordancewithinstitutionalpolicy.
Section IV — Icon Identification
Eject Button
DisposeofasElectricalandElectronicWaste
ºF
C
º
°C/°F Button
Medical
Equipment
Type BF Protection (Degree of protection against electrical
shock - there is no conductive connection to the patient)
Timer Button
Medical Electrical Equipment
Infrared Tympanic Electronic Thermometer
(1) Classified with respect to electical shock, fire and me-
chanicalhazardsinaccordancewithUL60601-1
(2)Classifiedwithrespecttoelectricalshock,fire,mechani-
calandotherspecifiedhazardsinaccordancewithCAN/CSA
C22.2No.601.1
Scan Button
SeeAccompanying   ChokingHazard
Documents

3
Infrared Tympanic Electronic Thermometer
The Infrared Tympanic Electronic Thermometer is a reliable and accurate temperature-taking device. The reason
for the accuracy of the Infrared Tympanic Electronic Thermometer is the design, controlled calibration methods
andstringentmanufacturingcontrols.Oneofthemostcriticalfunctionalpartsofathermometeristheprobe
cover. The Infrared Tympanic Electronic Thermometer probe cover, when placed on a Infrared Tympanic Electronic
Thermometer, serves as an infection control barrier between the patient and the device and the medium for
heat transmission from the patient to the thermometer. The functionality of the Infrared Tympanic Electronic
Thermometerprobecoverisextremelyimportantforpreventingdevicecontaminationandalsoforallowing
accurate patient temperature measurements.
The reason the Infrared Tympanic Electronic Thermometer and probe covers have satisfied our customers’
expectationsisduetotheintegrationofthesetwopartsduringthemanufacturingprocess.TheInfraredTympanic
ElectronicThermometerprobecovermoldingprocessparametersaretightlycontrolledtominimizevariationand
produce consistent and reliable products. The special grades of thermoplastic materials are also tightly controlled
and are specifically chosen to deliver consistent temperature measurements with Infrared Tympanic Electronic
Thermometers. The factory calibration and final determination of an acceptable Infrared Tympanic Electronic
Thermometer is dependent on the use of acceptable probe covers. The use of generic probe covers or other probe
covers not produced by PSSWorldMedical,Inc.isnotsupportedorsanctioned.TheuseofunauthorizedInfrared
TympanicElectronicThermometerprobecoverscouldjeopardizetheaccuracyoftheInfraredTympanicElectronic
Thermometer.CheckyourprobecovercartonfortheLumeon TM logo to be certain that your thermometer will
deliveranaccuratetemperatureeverytimeitisutilized.
Section V — Instructions for Use
Peak Select System™
The Infrared Tympanic Electronic Thermometer uses the patented Peak Select System. This system is different
than what is found in other similar thermometers in that it reduces technique errors by taking multiple readings
andautomaticallyselectsthemostaccuratetemperaturefordisplay.Whereasothersystemsonlyuse32readings,
thePeakSelectSystemuses100readingsfortheInfraredTympanicElectronicThermometer.
Equivalence Modes
The Infrared Tympanic Electronic Thermometer is an ear canal thermometer for neonates**, newborns,
children, and adults.
Prior to the introduction of tympanic thermometry, patient temperatures were measured in the mouth (oral), in the
rectum(rectal),underthearm(axillary),orinspecialcaseswithanindwellingSwan-Ganz™*catheter(core).Ifa
patient’s temperature was measured simultaneously with each of these methods, different absolute temperatures
would be obtained. The Infrared Tympanic Electronic Thermometer compensates for the average difference in
temperature at each of these sites by adjusting the displayed temperature.
A field calibration checker is available for this device. The device should be checked if it is dropped or if it is stored
atlessthan-25°Corabove55°C.
“ASTM laboratory accuracy requirements in the display range of 37 to 39°C (98 to 102°F) for Infrared
thermometers is ± 0.2°C (± 0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement
per ASTM Standards E 667-86 and E 1112-86 is ± 0.1°C (± 0.2°F).”
The following equivalence modes are available on the Infrared Tympanic Electronic Infrared Tympanic
Electronic Thermometer. Data is available from Kendall on request.

4
Infrared Tympanic Electronic Thermometer
Ear: In ear (EAR) mode, the display will indicate the absolute temperature without adjustment.
Oral: Inoral(ORL)mode,thetympanictemperatureisadjustedtodisplayanoraltemperatureequivalent.OralMode= 
Ear Mode + 0.60°C.
Axillary: Inaxillary(AX)mode,thetympanictemperatureisadjustedtodisplayanaxillarytemperatureequivalent.
 AxillaryMode=EarMode+0.04°C.
**Inneonatestheaxillaryequivalenceisrecommendedbecauseitisthecurrentstandardinneonates.
Core:Incore(CORE)mode,thetympanictemperatureisadjustedtodisplaythecoretemperatureequivalent. 
 CoreMode=EarMode+1.04°C.
Rectal: In rectal (REC) mode, the tympanic temperature is adjusted to display the rectal temperature equivalent.
RectalMode=EarMode+1.16°C.
Probe Covers
TheInfraredTympanicElectronicThermometerutilizesasingleusedisposableprobecoverduringtemperature
measurement. The probe cover was designed especially for use with the Infrared Tympanic Electronic
Thermometer.TheuseofprobecoversproducedbyanycompanyexceptPSSWorldMedical,Inc.willresultin
erroneous temperature measurement. In order to aid in infection prevention and control, always install a new
probe cover prior to taking a temperature. The probe covers are contained in a cassette that is located in the
thermometer base. To load a probe cover on the thermometer, firmly insert the probe tip into the probe cover.
Wheninstalledonthethermometer,theprobecovermembraneshouldbesmoothwithnoholes,tears,or
wrinkles. After the patient temperature has been taken, eject the probe cover by pressing the eject button and then
dispose of properly.
Temperature Measurement
1. Remove the Infrared Tympanic Electronic Thermometer from the base.
2. Inspect the probe lens. If any debris is present, clean the probe tip per the
directionsinSectionVII,Cleaning.Iftheprobetipisclean,proceedtostep3.
3. Install a probe cover by firmly inserting the probe tip into a probe cover. After
the probe cover is installed, the thermometer will perform a system reset.
The thermometer will then display dashes, the equivalence mode, and the
thermometer icon.
4. Inspect the probe cover to make sure it is fully seated (no space between cover
and tip base) and no holes, tears, or wrinkles are present in the plastic film.
ºF
C
º
ºF
C
º

5
Infrared Tympanic Electronic Thermometer
5. Place the probe in the ear canal and seal the opening with the probe tip. For
consistent results, ensure that the probe shaft is aligned with the ear canal.
6. Press and release the scan button.
7. Remove the probe from the ear as soon as the triple beep is heard.
8. The patient temperature and the probe eject icons will be displayed.
9. Presstheejectbuttontoejecttheprobecover.
10. Returnthethermometertobaseforstorage.
Temperature Recall
Afteratemperaturehasbeenacquired,thethermometerwillenter“off“modeafterapproximately10seconds.
Recallthetemperaturebypressingandreleasingthescanbuttonorbypressingandholdingthe°C/°Fbutton.
Temperature Display - Toggle °C or °F
Whenatemperatureisinthedisplay,theusermaypressandholdthe°C/°F button to toggle between degrees Celsius
and degrees Fahrenheit.
Sleep Mode
TheInfraredTympanicElectronicThermometerenterssleepmodeafter30-40secondsofnon-use.Towakeup
thethermometer,ejecttheattachedprobecoverand/orinstallanewprobecover.Thisenergyconservingfunction
optimizesbatterylife.
ºF
C
º
ºF
C
º

6
Infrared Tympanic Electronic Thermometer
Pulse Timer Mode
1. Press and hold the timer button to enter Timer mode. Press again to start the timer. The timer will
  runfrom0to60seconds.
 2. Thethermometerwillissueasinglebeepat15seconds,adualbeepat30seconds,atriplebeepat45
  seconds,andfourbeepsat60seconds.
 3. Pressthetimerbuttonatanypointduringthetimerfunctiontoreturnthethermometerto“off“mode.
 4. Attheendofthe60seconds,thethermometerwillwaittwosecondsandthenentersleepmode.
5. Return the thermometer to base for storage.
Thermometer Display Icons and Alarms
ThermometeroperationiscommunicatedtotheuserviatheLCDdisplayandanaudibledevicecontainedinside
the thermometer case. After the probe cover is installed or the batteries have been changed, the thermometer will
perform a system reset. The thermometer will perform an internal test to verify that the system components are
functioning properly.
Alarm Condition Display Mode
˚C
EAR
Patient temperature above specified range
Patient temperature below specified range
Ambient Temperature above specified range
Ambient Temperature below specified range
Low Battery
Dead Battery
˚C
EAR
EAR
EAR
˚C
EAR
The LCD displays the low battery icon. The low battery icon will remain on
until the battery is replaced or until the dead battery icon is displayed. After
the low battery icon is displayed, the user may take approximately 100
temperatures until the dead battery icon is displayed.
The LCD displays the dead battery condition. When any button is pressed, the
battery icon will flash several times and then the LCD will turn OFF. After the
battery icon is displayed, the batteries must be changed before the thermometer
can be used.

7
Infrared Tympanic Electronic Thermometer
If the display shows a system error 4 and the system error icon, the ambient conditions are changing too rapidly
forthedevicetobeused.Allowthedevicetoequilibratefor20minutesbeforeusing.
If the display shows any other system error, then reset the thermometer by installing a probe cover. If the system
error does not clear, then contact the factory for available service options. The applicable manufacturer addresses
arelocatedinSectionXII,CustomerService.
Biotech Mode
The biotech function is used to select the operational mode of the thermometer and to verify the installed software
version. All operational mode settings in biotech mode are stored in nonvolatile memory and retained through
system power cycles, such as changing batteries. All factory calibration parameters are also stored in nonvolatile
memory.
The factory default settings are shown below:
Temperature mode °C (unlocked)
Site mode Ear
Sitetext  On
Thebiotechmodeisaccessedbypressingandholdingthetimerand°C/°Fbuttonsforfourseconds.AllLCD
segments will light for one second, the thermometer will issue a single beep, and the display will show scrolling
dashes.Pressingthetimerbuttoncyclesthroughthebiotechmodes.Whenoptionsareavailablewithinamode,
the°C/°F button cycles through the options.
Pressingthetimerbuttonafterthesitetextdisplaywillreturntheusertotheinstalledsoftwareversion.Toexit
biotechmode,twooptionsareavailable:(1)pressandholdthe°C/°Fandtimerbuttonsforonesecond,or(2)the
devicewillautomaticallyexitbiotechmodeafterabout30secondsofinactivity.Anychangesaresaved.
The biotech mode sequence is shown below:
Software version
Displaystheinstalledsoftwareversionofdevice.Where“00”isthecurrentsoftwareversion.

8
Infrared Tympanic Electronic Thermometer
Temperature mode
Option Display
°C (unlocked)
Locked °C
Locked °F
°F (unlocked)
˚C
˚C
˚F
˚F
Site mode
Option Display
Oral
Core
Axillary
Rectal
Ear
*
ORL
*
CORE
*
AX
*
REC
EAR