INFRARED THERMOMETERS€¦ · Infrared thermometers are measuring instruments to take the body temperature. They are to be considered as “invasive medical devices (ear thermometer)

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