INFRARED THERMOMETERS

Speed, hygiene and measurement comfort

General presentation ClassificationInfrared thermometers are measuring instruments to take the body temperature. Theyaretobeconsideredas“invasivemedicaldevices(earthermometer)ornon-invasive(foreheadornon-contactthermometers)fortemporaryusethathavetheirownenergysource”inotherwords“active”.TheybelongtotheclassIIa.

DescriptionTheinfraredthermometerconsistsofaninfraredprobeanddisplay,and is powered by an internal energy source. Its operation is to determinate the body temperature of a subject by thermal radiation fromtheearcanaland/orthetympanicmembrane,orbythesurfaceoftheskin.Withinseconds,thedevicecapturestheinfraredemission and displays the recorded temperature.

EasyTemp®

Non-contact model

PackagingIncardboardboxwithinstructionsmanual, Storagepouch,Cartons of 12 pieces

Non-contactInfraredThermometer,forprofessionalorprivateusage,displaysthetemperatureinonesecond,noprobe-coverrequired,measurementrange32,2°Cto43,3°C,metrologyaccuracy±0,2°C,largeLCDscreen,alarmbeep,recallingmemories,batterylifeofapproximately1000measures.

Product code089000

Frontalix®

Forehead model

PackagingIncardboardboxwithinstructionsmanual, Storagepouch,Exhibitorof6pieces

Product code088000

Infrared forehead thermometer for professionalorprivateuse,temperaturedisplayinafewseconds,usewithouttip,measurementrange32,2°Cto43,3°C,measuringaccuracy±0,2°C,automaticself-test,wideLCDdisplay,alarmbeep,recallingmemories,batterylifeofaround5000measurements.(Manufacturing on request)

Ear model

Inframinix®

PackagingInrigidboxwithinstructionsmanual, Cardboardbox, Exhibitorof6pieces

Infrared ear thermometer for professional orprivateuse,temperaturedisplayinafewseconds,usewithouttip,measurementrange32,2°Cto43,3°C,measuringaccuracy±0,2°C,automaticself-test,pivotingprobeforambidextroususe,wideLCDdisplay,alarmbeep,recallingmemories,batterylifeofaround5000measurements.(Manufacturing on request)

Product code087001

Exhibitors of 6 infrared thermometers ear or forehead type (personalization on request)

EasyTemp® thermometerABS,ABS+TPR(forthethermometerbody),Silicone(fortheswitchbutton),Acrylic(forthedigitalscreen).

N.B.-Donotcontainlatex,andnoanimalderivatives.

N.B.-TheEN12470-5regulatorystandardspecifiesthemetrologicalandtechnicalrequirementsformedicalearthermometerswith maximumdeviceforintermittentevaluationofthehumanbodytemperature.Itisapplicabletodevicesthat,whenmeasuringtemperatures, arepoweredbyapowersourceeitherinternalormains,andwhichprovideanindicationofthehumanbodytemperaturebymeasuring the thermal radiation of all or part of the ear canal.Thedevicesexclusivelydesignedtomeasurethetemperatureofthetympanicmembranearealsocoveredbythisstandard.We chose to apply the requirements of this regulatory standard to all of our infrared thermometers.

Criteria Standards Results EasyTemp®, Inframinix®, Frontalix®

MEASUREMENTRANGE EN12470-5 32,2°Cà43,3°Cforourinfraredthermometers (35,5°Cto42°Cminimumstandardrequirement)

INCREMENTNUMBER EN12470-5 0,1°C

MAXIMUMTOLERATEDERRORINTHE EN12470-5 0,2°C(4measuringpointscontrolled) ENVIRONMENTALOPERATINGRANGE ANDTOLERATEDCLINICALREPEATABILITY EN12470-5 Complies

ENVIRONMENTALOPERATINGCONDITIONSAND EN12470-5 Complies EFFECTSOFSTORAGEANDLONGTERMSTABILITY

ELECTROMAGNETICCOMPATIBILITY EN60601-1-2 Complies

GENERALSAFETYREQUIREMENTS EN60601-1 Complies

MECHANICALSHOCK,DISPLAY,WARNINGSIGNALS, EN12470-5 Complies CHANGESINSUPPLYVOLTAGE,MODES,MATERIALS, (or non-applicable depending on cases) MECHANICAL,CLEANING,DISINFECTION,PROBECOVER, SAFETYTESTRUN,TESTMETHODS,USAGEINSTRUCTIONS

WARRANTYPERIOD 2years(InframinixandFrontalix),1year(EasyTemp)

MANUFACTURINGPLACE China

Frontalix® thermometer

Inframinix® thermometer

ABS,ABS+TPR(forthethermometerbodyandtheswitchbutton),Acrylic(forthedigitalscreen).

ABS(forthethermometerbodyandtheswitchbuttons),Acrylic(forthedigitalscreen),Silicone(forthepivotingprobe).

Composition (materials)

Technical specifications

N.B. - Inspections and controls at each step according to quality system procedures.

Finish products & cleaning Packing Shipping

COB (chip on board) testing

Assemble: PCB assembly + LCD liquid crystal display + housing (rear)

Manufacturing process (summary)

Outgoing quality control (OQC) sampling inspection before warehousing

Assemble: sensor + battery contact to housing (front)

Modifying resistance value

Printed circuit board (PCB) assembly (SMT=surface mount technology)

Integrated circuit chip bonding (COB=chip on board)

Assemble: housing (front) assembly + housing (rear) assembly

Sorted Garbage bin

BF type equipment

Warning and Disclaimer

Recyclable packaging

Consult instructions before use

V03

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THERMOFINAZ.A.C. CHAMLYS - B.P. 13077194 DAMMARIE-LES-LYS FRANCET : 33 (0) 1 64 37 81 96 F : 33 (0) 1 64 37 08 77www.thermofina.fr

PACKAGING AND MARKING

•Cartonof12thermometers for the non-contact model

•Exhibitorof6thermometers for the ear and forehead models

•Modelidentificationbyreferences, descriptions,colours

•Traceabilitybybatchnumber and manufacturing date

•Averageweigh2,55kgforthecarton ofnon-contactmodel, 0,9kgfortheexhibitorofearmodel, and0,6kgfortheexhibitorofforeheadmodel

•Recyclablematerial

Carton and exhibitor

•Unitarycardboardbox

•Detailedusermanualwithinstructions for use and storage

•Protectiveplasticcase(earmodel) or storage pouch (non-contact and forehead models)

•Modelidentificationbycompleteidentification

•Traceabilitybybatchnumberandmanufacturingdate

•Symbolsaccordingtoregulatorystandards

Box and user manual