Winnoz Haiim WH-001 User manual

“Haiim”Vacuum-assistedblood
collectionsystem
Pleasereadthisinstructionmanualcarefully
beforeoperatingthisproduct.
UserManual
A.【ProductDescription】
This product, “Haiim” Vacuum-assisted blood collection system (WH-001), is
composedoftwoparts:1)amaindevice(HD-001)and2)asingle-usedisposable
cassette (HC-001). The main device includes a pressure control system that
generatesnegativepressuretocreateavacuumeffectforcollectingblood.The
intendedpurposeoftheproductislimitedtoIVDuseonly.Whenoperatingthis
product,itisnecessarytouseabloodlancetwithaneedle(diameter≥0.8mm,
gaugenumber≤21G)orablade(width≥1.5mm)andamicro-collectiontube
(theinformationof compatiblemicro-collectiontubes isprovidedin SectionE,
Cassette(HC-001)GeneralSpecifications).
(1)MainDevice (2)Cassette (3)Micro-
collectiontube (4)Lancet
Whitelight:
Greenlight:
Bluelight:
2.Cassette（HC-001）
2.1BloodCollectionEntry:anopenendofthecassetteonwhereafingertip
shouldbeplaced.
2.2 Main Device Connector: a connector for connecting to the Cassette
Connector.
2.3TubeConnector:aconnectorwithaspecificdesignangleforconnectingto
acommercialmicro-collectiontuberecommendedinthisusermanual.
2.4O-ring.
2.5 Blood Collection Hole: the top entry of the capillary structure of the
cassetteforreceivingbloodspecimensfromafingertip.
2.3TubeConnector
2.1BloodCollectionEntry
2.2MainDevice
Connector
H.【PrecedingOperation】
Beforestarting,pleasepreparethefollowingitems:
B.【IntendedUse】
C.【Contraindications】
“Haiim”Vacuum-assistedbloodcollectionsystemisintendedtouseavacuumto
collect capillary blood from a puncture site. The product is composed of a
cassette able to connect with a single-use micro-collection tube and a main
deviceprovidingapressurecontrolfunction.Whenassembledandactivated,the
productcollectsbloodfromthepuncturesitetothemicro-collectiontube.This
productisforprofessionaluseonly.
1.Diseasesthatareassociatedwithbloodcoagulationdisordersorneedtotake
anyanti-coagulationmedication/treatmentmaycauseabnormalbloodloss.
2.Areas ofskininfection orskin conditions likecellulitis orabscessshould be
avoidedbecauseoftherisksofinoculatingthebloodwithbacteria,viruses,and
anysubstancethatcausedinfection.
D.【WarningsandPrecautions】
1.ProductSafety
1.1Beforestartingtousethisproduct,pleaseconfirmifthestandardvoltageof
thecountryorregionwhereyouaregoingtousetheproductisintherangeof
thetechnicalspecificationsofthepoweradapterprovidedinSectionEofthisuser
manual.
1.2Beforestartingtousethisproduct,pleaseverifythattheproducthascomplete
packagingshowninSectionF.Ifthereisanymissingpart,pleasekindlyreturnthe
wholeproducttowhereyoupurchaseditfromforareplacement.
1.3Donotapplyanyphysicalimpacttothemaindeviceandavoiditfromfalling.
1.4Thisproductcanbeusedinaprofessionalhealthcareenvironment.
1.5Thisproductisnotintendedforuseinresidentialenvironmentsandmaynot
provideadequateprotectiontoradioreceptioninsuchenvironments.
1.6Theproductshouldnotbeusedadjacenttoorstackedwithotherequipment.
1.7Donotinsertanythingintotheconnectorsʼholesortheoutercasegapsofthe
maindevice.
1.8Donotplacetheproductinalocationaccessibletochildrenorunauthorized
users.
3.InstructionsforSafeBloodDrawing
3.1Beforestartingtousethisproduct,pleasereadthisusermanualcarefullyand
otherdocumentsprovidedalongwiththeproduct.
3.2Thisproducthasbeendesignedforfingertipbloodcollection.Pleasedonot
giveitanyotheruses.
3.3Onlymedicalorhealthcareprovidersareeligibletooperatethisproductin
accordancewithlocalregulations.
3.4Themaindevicecanonlybeusedwiththecassettes.Pleasedonotuseany
othergoodssimilartothecassettes.
3.5Thecassetteisasingle-useconsumable.Pleasedonotreuseit.
3.6Donotuseanycassettewhoseindividualpackagingisdamagedorperforat-
edtoavoidanyrisksofcontamination.
3.7 Do not start to operate this product until the cassette has been correctly
installed.
3.8 For emergencies or accidents during blood drawing, please refer to the
systemoperationsettingstatedinSectionEofthisusermanual.
3.9Users shouldprepare other itemsthat mayberequired forblood drawing
accordingtoSectionH(e.g.,gloves,alcoholpads,etc.).
3.10Sincebloodisahigh-riskbiologicalspecimen,itisimportanttotakeproper
precautions every time when performing the blood collection process. Users
shallavoiddirectlytouchingthewoundsoranyareaswithblood.
3.11 Do not inject the collected blood specimen back into anyone's body to
avoidinfectionorfurtherrisks.
3.12Usageofthisproductperformingbyapersonunabletoproperlyoperate
theproductduetocolorblindness,blindness,orblurredvisionshallbeavoided.
3.13Pleasecomplywithlocalauthorityregulationsanduseappropriatebiologi-
calwastedisposalprotocolstodisposeofusedcassettesandotherconsumables
thathavebeenusedorthathavebeenincontactwithbloodspecimens.Regard-
ingthedisposalofthemaindevice,pleasefollowyournationalrequirements.
4.CleaningandMaintenanceConsiderations
4.1Pleaseavoiddust,dirt,orothercontaminantsenterstheCassetteConnector
of the main device (see section G, 1.4) or accumulated on the main device
surfaces.
4.2Themaindeviceshallbecleanedregularly,especiallywhenithasbeenin
contactwithbloodspecimens,topreventtheriskofcross-contamination.For
moredetails,pleaserefertotheSectionJofthisusermanual.
4.3Itisforbiddentodisassembleoraltercompletelyorpartiallyboththemain
deviceandthecassette.Ifso,thefunctionalityandsafetyofthisproductarenot
assured.
4.4Iftheproductrequiresmaintenance,please contactthecustomer service
providedbyWinnozTechnology,Inc.
E.【ItemsandSpecifications】
“Haiim”Vacuum-assistedbloodcollectionsystem
MainDevice(HD-001)GeneralSpecifications
F.【ProductImages】
Thecompletepackagingof“Haiim”Vacuum-assistedbloodcollectionsystem
isshownbelow:
1.Maindevice(HD-001),includingPowerAdapter(GEM12I12-P1J)
EMCStandards ·ConductedEmission(IEC60601-1-2:2014)
·RadiatedEmission(IEC60601-1-2:2014)
·Harmonicdistortion(IEC60601-1-2:2014)
·Voltagefluctuationsandflicker(IEC60601-1-2:2014)
·ESD(IEC60601-1-2:2014)
·RSRadiatedRFEMfields(IEC60601-1-2:2014)
·RSProximityfieldsfromRFwirelesscommunications
equipment(IEC60601-1-2:2014)
·EFT(IEC60601-1-2:2014)
·Surge(IEC60601-1-2:2014)
·CS(IEC60601-1-2:2014)
·PFMF(IEC60601-1-2:2014)
·Voltagedipsandinterruptions(IEC60601-1-2:2014)
Dimension
Weight
Recommended
Micro-collection
Tube
Specification
Compatible
Device
Packaging
Operating
Condition
ShelfLife
Width:18mm/Length:32.5mm/Height:42mm
(excludingtheheightoftheassembledmicro-
collectiontube)
4g(Netweight)
1.BDMicrotainer®TubewithBDMicrogard™Closure
0.5mL(Withoutgel)
2.EVSingle-useContainersforHumanCapillaryBlood
SpecimenCollection0.5mL(Withoutgel)
Itisnotrecommendedtouseamicro-collectiontube
withgel.
“Haiim”Vacuum-assistedbloodcollectionsystem.
MainDevice(HD-001)
Singlepackage(non-sterile)
Temperaturerange：0~40℃
Humidityrange:30~75%RH
3years
Dimension
Weight
System
Operation
Setting
PowerAdapter
Specifications
Compatible
Cassette
Operating
Conditions
Storage
Conditions
Width:62mm/Length:123mm/Height:62mm
219g(netweight)
-PresstheStart-Button(SectionG,1.3)tostart.
-Tostopthemaindevicewhenfunctioningincase
ofemergencyoraccidents,presstheStart-Button
foronesecond.
-Automaticcycletime:2min
Model:GEM12I12-P1J
InputRating:100-240VAC,50-60Hz,0.4-0.2A
OutputRating:12Vdc/1A
CableLength:1.8m
Weight:118g
“Haiim”Vacuum-assistedbloodcollectionsystem
Cassette(HC-001)
Temperaturerange：0~40℃
Humidityrange:30~75%RH
Temperaturerange：0~40℃
Humidityrange:30~75%RH
Avoiddirectexposuretosunlight
ItemName Model Remarks
“Haiim”Vacuum-assisted
bloodcollectionsystem
UserManual
MainDevice
Cassette
Poweradapter
Accessory
Accessory
“Haiim”Vacuum-assistedbloodcollectionsystem
Cassette(HC-001)GeneralSpecifications
2.Cassette(HC-001)
Yellowlight:
2.ElectricalSafety
2.1OnlyuseapoweradapterhavingthemodelstatedinSectionEofthisuser
manual.Anypoweradapterhavingamodeldifferentfromtheaforementioned
modelisprohibited.
2.2 Please do not use any other cables or accessories not approved by the
manufacturerinthisusermanualtoavoidnegativeinfluenceonelectromagnetic
compatibility.
2.3Donotconnectthisproducttoelectricsocketswithwethands.
2.4IfabnormalbehaviorisobservedduetoEMdisturbances,pleaserelocatethe
maindeviceaccordingly.
2.5Theremaybeaninteractionbetweentheproductandanelectricequipment
duetoelectromagneticradiation.Itʼsrecommendedasafetydistanceofatleast
30 cm between the product and electric equipment, especially sensitive
equipment.
2.6ThisProductismedicalelectricalequipmentthatneedsspecialprecautions
regarding EMC and needs to be installed according to the EMC information
provided.
-1- -2-
1.1PowerAdapterConnector
1.2Switch
1.3Start-
Button
1.5IndicatorLights
1.4Cassette
Connector
ON OFF
ON OFF
1.1.PowerAdapterConnector:aconnectorshallbeconnectedtoapoweradapter
(GEM12I12-P1J)tohavepowerinputbeforebloodcollection.
1.2. Switch: the switch of the main device. By moving Switch, the main device
couldbeturnedonoroff.
1.2.1.ONposition.
1.2.2.OFFposition.
1.3.Start-Button:abuttonforstartingabloodcollectionprocessbygentlypress.In
caseofemergencyoraccidents,pressagaintheStart-Buttonfor1secondtostop
thebloodcollectionprocess.
1.4.CassetteConnector:aconnectorforconnectingtotheMainDeviceConnector.
1.5. Indicator Lights: the indicator lights consist of three LED lights, showing
differentcolorscorrespondingtodifferentstatusasdescribedbelow:
1.MainDevice(HD-001)
G.【DescriptionofKeyItems】
ThefunctionofeachkeyitemoftheProductaslabeledandbrieflydescribed
below:
-3-
1.2.1
1.2.2
The Indicator Lights show the white color
rightafterpoweringonthemaindevice.Then,
the Indicator Lights will turn to the green
colorandgointostandbymode.
Standbymode.
TheIndicatorLightsaregreenwhenthemain
device is in a normal condition, and is not
collectingblood.
The yellow color means negative pressure
doesnotreachthepresetvalue.
The Indicator Lights first show the yellow
color once pressing the Start-Button. If the
pressure does not reach the preset value
within 10 seconds, the Indicator Lights will
turntothegreencolor,andthemaindevice
willgobacktothestandbymode.Pleaserefer
toScenario1ofSectionLfortroubleshooting.
Blood collection mode. When the negative
pressurereachesthepresetvalue,theIndicator
Lights will turn from the yellow color to the
bluecolorandmaintainatbluefor2minutesto
completethebloodcollectionprocess.
IftheIndicatorLightsturnfromthebluecolor
totheyellowcolorduringthebloodcollection
process,pleaserefertoScenario2ofSectionL
fortroubleshooting.
2.4O-ring
2.5BloodCollectionHole
Aspecificdesign
angleofthe
TubeConnector
(6)Gloves (7)Alcoholpad,
orotherconsuma-
blesfordisinfection
(8)Cottonswab
(9)Cottonball,or
otherhemostatic
consumables
Storage
Conditions
Temperaturerange：0~40℃
Humidityrange:30~75%RH
Avoiddirectexposuretosunlight
(5)Wristpad
®

I.【SystemOperation】
1.Turningonamaindevice
2.1Connectingacassettetoacommercialmicro-collectiontuberecommended
inthisusermanual.Pleaserefertothepicturesbelow:
2.Assemblingsteps
2.2Connectingthecassettetothemaindevice.Pleaserefertothepicturebelow:
M.【MANUFACTURERʼSdeclaration‒Electro-
magneticCompatibility‒forallMEEQUIP-
MENTandMESYSTEMS】
Manufacturerʼsdeclaration-electromagneticimmunity
TheWH-001isintendedforuseintheelectromagneticenvironment(forprofe-
ssionalhealthcare)specifiedbelow.
ThecustomerortheuseroftheWH-001shouldassurethatitisusedinsuch
anenvironment.
Immunity
Test IEC60601
TestLevel
Compliance
Level
Electromagnetic
environment-
guidance
(forprofessional
healthcare
environment)
Electrostatic
discharge(ESD)
IEC61000-4-2
Floorsshouldbewood,
concreteorceramictile.
Iffloorsarecoveredwith
syntheticmaterial,the
relativehumidityshould
beatleast30%
Contact:±8kV
Air±2kV,±4kV,
±8kV,±15kV
Contact:±8kV
Air±2kV,±4kV,
±8kV,±15kV
Electricalfast
transient/burst
IEC61000-4-4
Mainspowerquality
shouldbethatofatypical
professionalhealthcare
environment.
±2kVforpower
supplylines
±1kVforinput/
outputlines
±2kVforpower
supplylines
Notapplicable
Surge
IEC61000-4-5
±0.5kV,±1kV
line(s)toline(s)
±0.5kV,±1kV,±2kV
line(s)toearth
±0.5kV,±1kV
line(s)toline(s)
Notapplicable
Mainspowerquality
shouldbethatofatypical
professionalhealthcare
environment.
VoltageDips,
shortinterrup-
tionsandvol-
tagevariations
onpowersupp-
lyinputlines
IEC61000-4-11
Voltagedips:
0% ;0.5cycle
0% ;1cycle
70% ;25/30cycles
Voltageinterruptions:
0% ;250/300cycle
Voltagedips:
0%;0.5cycle
0%;1cycle
70%;25/30cycles
Voltageinterruptions:
0% ;250/300cycle
Mainspowerquality
shouldbethatofatypical
professionalhealthcare
environment.
IftheuseroftheWH-001
requirescontinuedopera-
tionduringpowermains
interruptions,itisrecom-
mendedthattheWH-001
bepoweredfromanunin-
terruptiblepowersupply
orabattery.
Powerfrequency
(50,60Hz)
magneticfield
IEC61000-4-8
30A/m
50Hzor60Hz
30A/m
50Hz
TheWH-001powerfre-
quencymagneticfields
shouldbeatlevelscha-
racteristicofatypicallo-
cationinatypicalprofe-
ssionalhealthcareenvi-
ronment.
NOTEisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
Parallelly
Pushitinparallelly
K.【AdverseEventNotification】
Intheeventthatthereisanunexpectedaccidentordefectiveproduct,please
notifytheEuropeanauthorizedrepresentativeofWinnozTechnology,Inc.:
MedNetEC-REPGmbH:Tel:+49(0)25132266-64;Fax:+49(0)25132266-22;
Email: [email protected]; Address: Borkstrasse 10, 48163 Muenster,
Germany.
L.【Troubleshooting】
1.Causeofissue：thereisnoairtightattheinterfacesstatedbelow
2.Troubleshooting：
(a)Pleaseconfirmthatthemicro-collectiontubeiscorrectlyalignedwiththe
cassette,andtheO-ringofthecassetteshouldnotbedeformed.
(b)Pleasecheckifthecassetteissecuredaccuratelyandfirmlytothemain
device.Itisrecommendedtore-insertthecassetteintothemaindeviceand
pushthecassetteinwardtothemaindeviceslightly.
(c)PleaseadjustthepositionofyourfingertiptomakesuretheBlood
CollectionEntryiscorrectlycovered.IfyourfingertipcannotcovertheBlood
CollectionEntry,itissuggestedtotryotherfingers.
(d)Awetfingerwillaffecttheairtightofthesystem.Pleasedryyourfinger
beforethebloodcollectionprocessifyouwashedyourhandsorusean
alcoholpadtodisinfectyourfingertip.
(e)Pleasemakesurethatyourfingertipdoesnotapplypressureonthe
cassette.Itisrecommendedtorestyourarmandwristonadeskorasupport
object.
(f)Iftheissuecannotbesolvedaftertheaboveprocedures,pleasecontact
thecustomerserviceprovidedbyWinnozTechnology,Inc.
Scenario1 TheIndicatorLightsdonotturnfromyellowtobluein3-10secondsafter
pressingtheStart-Button.
Inordertowelloperatethisproduct,pleasereadthefollowinginstructionsand
correspondingpicturescarefully:
1.1Connectingamaindeviceandapoweradapter(GEM12I12-P1J)through
thePowerAdapterConnector.
1.2Connectingthepoweradaptertoapoweroutlethavingasuitablerange
ofInputRatingstatedinSectionE.
1.3MovingtheSwitchtotheONposition.
Toensureairtightduringthebloodcollectionprocess,pleaseconfirmthat
theangleofthemicro-collectiontubeopenendiscorrectlyalignedwith
thespecificdesignangleoftheTubeConnectorofthecassette.Pleasenote
thattheO-ringshouldnotbedeformedwhenassembling.
(1) Please insert the cassette into the main device and do not tilt the
cassettewheninserting.
(2) To ensure the cassette is installed firmly, please push the cassette
inwardtothemaindevice.
(1)Washanddryyourhands.
(2)SelectafingertobeprickedandputontheBloodCollectionEntry(SectionG,
2.1).Pleasekeeprelaxingyourfingertoavoidunnecessarypressureenforcedon
thecassetteandrestingyourwristandarmonadeskorasupportableobject.
Please note that the user does not need to prick the finger at this step. For
choosingafingertobepricked,pleaserefertostep4ofthisSection.
(3)PresstheStart-button,andyouwouldhearmachinerysound,feelsuctionat
your fingertip, and observe that the Indicator Lights changes from green to
yellowandthentobluein3-10seconds,indicatingthesystemhassuccessfully
enteredintothebloodcollectionmode.Ifsucceed,pleasepresstheStart-button
againfor1secondtostoptheprocessandproceedstep4tostep6ofthisSection
for the blood collection. Otherwise, please refer to Scenario 1 of Section L for
troubleshooting.
3.Checkingairtightofthesystem
Beforeconductingthebloodcollectionprocess,theusershallchecktheairtight
ofthesystembyinspectionifthemicro-collectiontubealongwiththecassetteis
correctlyinstalledonthemaindeviceperthefollowinginstructions:
5.Bloodcollectionprocedure
J.【CleaningandDisinfecting】
1.Althoughtheuserneedstooperatethemaindevicewithcleandisposable
gloves,itisstillrecommendedtocleananddisinfectthemaindevice.
2.Pleaseconfirmthatthemaindeviceisnotconnectedtoanypowersource
beforecleaninganddisinfectingit.
3.Pleasecleananddisinfectthemaindevicebeforeandaftereachuserʼsuse,
andoncethereisanydirtorbloodonthemaindevice.
4.Pleaseuseoneofthefollowingcleaningmaterials:
(a)Acleangauze,cottonswab,oranyfunctionalanalogue,moistened
withacleaningagent,includingbutnotlimitedto,CaviCide,
MEDASEPT®100oranysimilarCE-markedmedicaldevice(without
hypochlorousacidanditsderivatives)applyingtodisinfection.
(b)Anavailablecommercialdisinfectionproduct,includingbutnot
limitedto,CaviWipes,SuperSani-ClothPlusoranysimilarCE-marked
medicaldevice(withouthypochlorousacidanditsderivatives).
(c)Activityspectrumoftherecommendedcleaningagents:
5.Cleaninganddisinfectingprocedure:
(a)Wearcleandisposablegloves.
(b)Cleantheexteriorsurfacewithacleaningmaterialaforementioned.
(c)CleantheCassetteConnectorusingacottonswabmoistenedwitha
cleaningagentaforementioned.
(d)Ifthecleaningmaterialisstained,repeatabovestep5(b)or5(c)with
anewcleaningmaterial.
(e)Standandair-drythecleanedarea.
6.CAUTIONSofthecleaninganddisinfectingprocedure
(a)Beforeusinganycleaningmaterialsaforementioned,pleasecarefully
readtheIFUofthecleaningmaterialtobeused.
(b)AVOIDgettinganymoistureordirtintoanyopeningsofthemain
device.
(c)DONOTsprayanycleaningagentdirectlyontothemaindevice.
(d)DONOTuseanyorganicsolventstocleanthemaindevice.
6.Aftercompletingbloodcollection
Removethe
fingertipfrom
thecassette
Retrievethe
cassetteand
disconnectthe
micro-collection
tube
Proceedwitha
specimen
testingbased
onneeds
1234
Coverthecap.
Ifapplicable,
mixthespecimen
withthe
anticoagulant
1
Selectafingertip
tobepricked
Priority
1
2
31
2
3
＞ ＞
2
Massagethefinger
frombottomtotop
for3times
x3
Makethefingertip
congesteduntilit
ispricked
3
Disinfect
thefingertip
45
Prickthefingertip
attheSuggested
Area
Wipeoffthe
firstdropofblood
6
PresstheStart-
Buttonandavoidto
applypressureon
thecassette[Note]
9
Massagethefinger
frombottomtotop
untilablooddrop
appears
7
Gentlyplacethe
puncturesiteright
abovetheBlood
CollectionHole
8
4.Fingerselectionpriority
Therecommendedpriorityoffingersforblooddrawingarefollows:ringfinger>
middlefinger>indexfinger.Pleasenotethatthefingertipʼssizeandelasticitywill
affect the efficacy of blood collection. The fingertip's size is larger and the
fingertipismore pliable,theefficacyofblood collectionwillbeimproved.The
generalorder offingertip sizeisas shown:middle finger> index finger≈ ring
finger.Itisnotrecommendedtouseafingertiphavingcalluses.Userscanchoose
fingersdependentontheirphysicalconditions.
[Note]:Pleaserelaxyourfingerandrestyourwristandarmonadeskorasupport-
ableobject.
Cassette
Thecassetteissingle-usedisposable.Pleasediscarditasabiologicalwaste
accordingtolocalauthorityregulations.
MainDevice
-4-
1.Ifthesystemdoesnotrunproperly
Generally,onceafingertipisproperlyplacedontheBloodCollectionEntryofa
cassetteandtheStart-Buttonispressed,theIndicatorLightswillfirstturnfrom
thegreencolortotheyellowcolor,indicatingthatthemaindevicewillstartto
producenegativepressure.In3-10seconds,theIndicatorLightswillturnfromthe
yellow color to the blue color, stating that the negative pressure reaches the
preset value and the blood collection process starts. The Indicator Lights will
maintainatbluecolorfor2minutesto completethebloodcollectionprocess,
andthenthemaindevicewillgobacktothestandbymode.
IfthecolorsofIndicatorLightdonotchangeaccordingtotheabovestatements
orthemaindevicestopsduringthebloodcollectionprocess,pleaserefertothe
followingscenariosfortroubleshooting.
(a)Thecassetteandthemicro-collectiontube.
(b)TheMainDeviceConnectorofthecassetteandtheCassetteConnectorof
themaindevice.
(c)UserʼsfingertipandtheBloodCollectionEntryofthecassette.
1.Causeofissue：anotairtightstatussuddenlycausedbetweenthefingertipand
theassembledcassette.
2.Troubleshooting：
(a)PleaseadjustthepositionofyourfingertiptomakesuretheBlood
CollectionEntryiscorrectlycovered.IfyourfingertipcannotcovertheBlood
CollectionEntry,itissuggestedtotryotherfingers.
(c)Pleasemakesurethatyourfingertipdoesnotapplypressureonthe
cassette.Itisrecommendedtorestyourarmandwristonadeskorasupport
object.
(d)Iftheissuecannotbesolvedaftertheaboveprocedures,pleasecontact
thecustomerserviceprovidedbyWinnozTechnology,Inc.
(e)Ifyouneedtostoptheprocess,pleasepresstheStart-Buttonfor1second.
Scenario2 Duringthebloodcollectionprocess,theIndicatorLightsturnfromthe
bluecolortotheyellowcolor.
2.Iftheusercouldnotcollectenoughbloodvolumeorqualityblood
Duetomultipleheterogeneous factorssuchas age,microvasculardistribution,
bloodcirculation,atmosphericpressure,etc.,thebloodvolumecollectedwiththe
productcouldvaryindifferentscenarios.Notwithstanding,whensufficientblood
specimenscannotbecollected,pleasetrythefollowingmethodstoobtainmore
blood or seek specialized medical assistance or try other blood collection
methods.
(a)Beforebloodcollection,itisrecommendedthatyouwarmandmassageyour
fingersproperly.
(b)Accordingtoexperimentaldata,hyperhidrosisandhypotensionmayaffect
thebloodvolumecollectedbecauseawetfingerwillaffecttheairtightofthe
system.Pleasedryyourfingerbeforethebloodcollectionprocessifyouwashed
yourhandsoruseanalcoholpadtodisinfectyourfingertip.
(c)Ifyouhadappliedhandcreamonyourhand,pleasewashitawayanddry
yourfingersasitmaycontaminatethebloodspecimen.
(d)Theairtightofthesystemaffectsthecollectedbloodvolume.Pleaseconfirm
thesystemisairtightbeforebloodcollectionbyfollowingtheinstructionsinthe
scenario1ofSectionL.
(e) When operating this product, it is necessary to use a blood lancet with a
needle(diameter≥0.8mm,gaugenumber≤21G)orablade(width≥1.5mm).
Inaddition,usingalancetwhosediameterorwidthissmallerthanthatof21G
wouldincreasehemolysisrisk.
(f)Supposebloodcannotbesuccessfullycollectedafterfollowingthecustomer
serviceʼsguidanceandconfirmingthattheproductfunctionsnormallyandhas
beenoperatedcorrectly,theproductmaynotbeapplicabletothisuser.
-5-
IFU-1801
EN2020-09rev.5.7
-6-
TheWH-001isintendedforuseintheelectromagneticenvironment(forprofe-
ssionalhealthcare)specifiedbelow.
ThecustomerortheuseroftheWH-001shouldassurethatitisusedinsuch
anenvironment.
Immunity
Test IEC60601
TestLevel
Compliance
Level
Electromagnetic
environment-
guidance
(forprofessional
healthcare
environment)
Manufacturerʼsdeclaration-electromagneticimmunity
NOTE1At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagation
isaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.
ConductedRF
IEC61000-4-6
RadiatedRF
IEC61000-4-3
3Vrms:
0.15MHz-80MHz
6Vrms:
inISMbandsbetween
0.15MHzand80MHz
80%AMat1kHz
3V/m
80MHz‒2.7GHz
80%AMat1kHz
3Vrms:
0.15MHz-80MHz
6Vrms:
inISMbandsbetween
0.15MHzand80MHz
80%AMat1kHz
3V/m
80MHz‒2.7GHz
80%AMat1kHz
PortableandmobileRF
communicationsequipment
shouldbeusednocloserto
anypartoftheWH-001
includingcables,thanthe
recommendedseparation
distancecalculatedfromthe
equationapplicabletothe
frequencyofthetransmitter.
Recommendedseparation
distance:
 =1.2√
 =1.2√80MHzto800MHz
 =2.3√800MHzto2.7GHz
Where  isthemaximum
outputpowerratingofthe
transmitterinwatts(W)accor-
dingtothetransmittermanu-
facturerand
 istherecom-
mendedseparationdistance
inmetres(m).
Interferencemayoccurinthe
vicinityofequipmentmarked
withthefollowingsymbol:



SuggestedArea
(+:thecenterof
thefingerprint)
Recommendedreactiontime
MEDASEPT®
100
SuperSani-
ClothPlus
30 sec.
30 sec.
30 sec.
30 sec.
1 min.
1 min.
N.A.
2 min.
30 sec.
5 min.
N.A.
1 min.
N.A.
N.A.
30 sec.
30 sec.
30 sec.
30 sec.
30 sec.
30 sec.
15 sec.
15 sec.
15 sec.
15 sec.
N.A.
N.A.
3 min.
3 min.
N.A.
30 sec.
N.A.
N.A.
Activity
Spectrum CaviCide/
CaviWipes
Bactericidal
Fungicidal
Virucidal
Mycobactericidal/
Tuberculocidal
Pseudomonas aeruginosa
Staphylococcus aureus
Enterococcus spp. (incl. VRE)
MRSA
3 min.
3 min.
3 min.
3 min.
Candida albicans
Aspergillus brasiliensis
Trichophyton mentagrophytes
1 min.
1 min.
3 min.
HBV/HCV/HIV
Influenza A2/H1N1/H5N1
Vaccinia virus
Coronavirus
HSV-1/HSV-2
BVDV
2 min.
2 min.
2 min.
2 min.
2 min.
2 min.
Mycobacterium terrae
Mycobacterium avium
Mycobacterium bovis
1 min.
1 min.
3 min.
Note N.A. is for Not Available.

Manufacturerʼsdeclaration-electromagneticimmunity
TestspecificationsforENCLOSUREPORTIMMUNITYtoRFwireless
communicationsequipment
TheWH-001isintendedforuseintheelectromagneticenvironment(forprofe-
ssionalhealthcare)specifiedbelow.
ThecustomerortheuseroftheWH-001shouldassurethatitisusedinsuchan
environment.
Test
Frequency
(MHz)
Banda)
(MHz)
Servicea) Modula-
tionb)
Maximum
Power
(W)
Dis-
tance
(m)
Immunity
Test
Level
(V/m)
Compliance
Level
(V/m)
(for
professional
healthcare)
385 380-390 TETRA400
Pulse
modula-
tion
b)
18Hz
1.8 0.3 27 27
450 430-470 GMRS460,
FRS460
FM
c)
±5kHz
deviation
1kHzsine
2 0.3 28 28
704-787 LTEBand
13,17
Pulse
modula-
tion
b)
217Hz
0.2 0.3 9 9
710
745
780
800-960
GSM800/
900,
TETRA800,
iDEN820,
CDMA850,
LTEBand5
Pulse
modula-
tion
b)
18Hz
2 0.3 28 28
810
870
930
1700-
1990
GSM1800,
CDMA1900,
GSM1900,
DECT,
LTEBand
1,3,4,25,
UMTS
Pulse
modula-
tion
b)
217Hz
2 0.3 28 28
1720
1845
1970
2450 2400-
2570
Bluetooth,
WLAN,
802.11
b/g/n,
RFID2450,
LTEBand7
Pulse
modula-
tion
b)
217Hz
2 0.3 28 28
5100-
5800
WLAN
802.11
a/n
Pulse
modula-
tion
b)
217Hz
0.2 0.3 9 9
5240
5500
5785
NOTEIfnecessarytoachievetheIMMUNITYTESTLEVEL,thedistancebetweenthetrans-
mittingantennaandtheMEEQUIPMENTorMESYSTEMmaybereducedto1m.The1
mtestdistanceispermittedbyIEC61000-4-3.
a)Forsomeservices,onlytheuplinkfrequenciesareincluded.
b)Thecarriershallbemodulatedusinga50%dutycyclesquarewavesignal.
c)AsanalternativetoFMmodulation,50%pulsemodulationat18Hzmaybeused
becausewhileitdoesnotrepresentactualmodulation,itwouldbeworstcase.
IFU-1801
EN2020-09rev.5.7
-7- -8- -9-
N.【SymbolsDescription】
Symbol Definition
SN
Thewarningsignsorpatternsmarkedonthelabelofthismanualorthe
outerboxareintendedtomaintainthesafetyofitsuseandtopreventthe
userorothersfrombeinginjuredorpropertydamageinadvance.
Serialnumber
Remark:Pleasecheckthewarningsandprecautions
Single-useonlyanduseditforsterilizationbagofcassette
(Donotreuseit)
Contactwithelectricshockprotection
(Donotcontactwiththeheart)
Doubleinsulation
Non-generalhouseholdwaste
Manufacturernameandaddress
Dateofmanufacture(year/month/day)
Donotuseifthepackageisdamaged
Maximumandminimumtemperature
Pleasereadtheinstructionsbeforeuse
Manufacturingbatchnumber
Cataloguenumber
REF
LOT
EuropeanAuthorizedRepresentative
REP
RecommendedseparationdistancebetweenportableandmobileRF
communicationsequipmentandtheWH-001
TheWH-001isintendedforuseinanelectromagneticenvironment(forprofe-
ssionalhealthcare)inwhichradiatedRFdisturbancesarecontrolled.Thecus-
tomerortheuseroftheWH-001canhelppreventelectromagneticinterference
bymaintainingaminimumdistancebetweenportableandmobileRFcommu-
nicationsequipment(transmitters)andtheWH-001asrecommendedbelow,
accordingtothemaximumoutputpowerofthecommunicationsequipment.
Ratedmaximum
outputpowerof
transmitter
W
Separationdistanceaccordingtofrequencyof
transmitter
m
150kHzto80MHz
=1.2√
80MHzto800MHz
=1.2√
800MHzto2.7GHz
=2.3√
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommended
separationdistance
 inmeters(m)canbeestimatedusingtheequationapplicableto
thefrequencyofthetransmitter,where
 isthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmittermanufacturer.
NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrange
applies.
NOTE2Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagation
isaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.
 
WinnozTechnology,Inc.
5F.-1No.238,LianchengRd.,ZhongheDist.,NewTaipeiCity
235,Taiwan
Telephone:+886222217879
Website:www.winnoz.com
Email:[email protected]
WinnozTechnology,Inc.hasentrustedGigatekInc.formanufacturing.
MadeinTaiwan
R.O.C.(Taiwan)Patent：I652463
U.S.Patent：10,136,848
EuropeanPatent：EP3445311
MedNetEC-REPGmbH
Borkstrasse10,
48163Muenster,Germany
EC REP IVD
®