freestyle optium neo h · 2016-05-10 · the freestyle opum neo h system at a glance high contrast...

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FreeStyle Optium Neo H Blood Glucose and Ketone Monitoring System

Healthcare professional portrayal.

Glucose Ketones

TheFreeStyleNeoHcanperformbothbloodglucoseandbloodKetonetests.Ensuretofamiliariseyourselfwithbothmodules.Clickonthemodulebelow.

Patient testing

Quality Control

Maintenance

Patient testing

Quality Control

Maintenance

AnIntroduc+ontoFreeStyleOp+umNeoH

TheFreeStyleOpAumNeoHSystemataGlance

High contrast display Displays meter home screen, test results

and other important information

Up button •  Use to mark a venous blood test

•  Adjust settings

Test strip port Where the test strip is inserted

Logbook

Down button •  Used to mark a control solution test

•  Adjust settings

Power button Press to:

•  Turns meter on and off

•  Returns to the home screen

•  Saves settings

USB port Insert a data cable for uploading test results to a computer

TheFreeStyleOpAumNeoHBloodGlucoseTestStrip

TheFreeStyleOpAumNeoHmeterisdesignedtobeusedonlywithFreeStyleOpAumNeoHBloodGlucoseTestStrips.• 0.6μLsamplesize• 5-secondresultcountdown• Assayrange1.1-27.8mmol/L• Haematocritrange15-65%• ToporApsampleapplicaAon• VisualconfirmaAonofsufficientsample• Filltriggerensuressufficientsample• SampleTypes–Capillary,venous,arterial&neonatal• Eachpackcontains100individuallyfoilwrappedteststrips,calibraAonbarandteststripinsert

MetercalibraAon

•  ThecalibraAonprocedureprogrammesthemeterwiththelotnumber,expirydateandteststriptechnology

•  Alwayscalibratethemeterwitheachnewpackofteststrips–failuretocalibrateproperlywillcauseincorrectresults

•  Withthelotnumberfacingtowardyou,insertthecontactbarsofthecalibratorintothemeter.ThemeterturnsonautomaAcally

•  LOTandthelotnumberappearinthedisplaywindow•  Checkthatthelotnumberonthemeterdisplaywindowmatches

withthenumberontheteststripcalibratorandthelastfivedigitsonboththeteststripfoilpacketandteststripinsert

•  RetainthecalibraAonbarfortheduraAonofthatpack•  CalibraAoniscomplete•  Onlyusethecalibratorthatispackagedinthepackofteststrips

youareusing

PerformingaPa+entTestThe FreeStyle Optium Neo H system enables easy and accurate bedside testing of blood glucose levels

} 5 second test time

} Small 0.6 μL sample size

} Calibrator provides expiry check and

calibrates the meter

} Control solution mark

Blood glucose testing

PaAentTesAng1.  Preparethesamplesite:

i.  Beforeyouobtainablooddrop,makesurethesamplesiteisclean,dryandwarm

ii.  Hangthearmdownbeforelancingthesamplesite,tohelpaidbloodflow

2.  Opentheindividuallyfoilwrappedteststripatthenotchandteardown

3.  InserttheteststripintothemeterunAlitstops.Thiswillturnthemeteron.

4.  CheckthattheLOTnumberofteststripyouareusingmatchestheLOTnumbershownonthemeterdisplay

5.  The blinks,indicaAngthemeterisreadyforyoutoapplyasampletotheteststripi.  EnsureyoufolloworganisaAonalpolicyforsamplecollecAon

PaAenttesAng

6.  IftesAngglucoseonvenousbloodpressthetomarkthetestunAlappearsindicaAngthatthemeterisnowreadyforyoutoapplyvenousbloodtotheteststrip7.  Applyasamplewiththemeterinahorizontal(flat) posiAontoavoiditenteringtheteststripport8.  Ifyouareapplyingthesamplefromasyringe,applyaway

fromthedirecAonoftheteststripport

PaAenttesAng

9.  HoldsampletotheteststripunAl3shortlinesappearonthescreen

10.  Theresultswillbedisplayedafera5-secondcountdown

PaAenttesAng

Whentheresultappearsonthemeterscreenthetestiscomplete.Theresultswillbestoredinthemeter’smemory.Pressandholdthebuhontoturnoffthemeter.

SummaryforbloodglucosetesAng

1.  Insertsteststrip,blinks

2.Applyblood3.Sampledetected,5secondscountdownbegins

4.Resultisdisplayed

Outofrangeindicators

Highbloodglucoseresults•  AresultfallingoutsidetherangesetbyyourorganisaAonmay

requiresomeintervenAonfromtheoperator,suchasrepeaAngthetest–  Themeterwilldisplayasolidyellowarrow

•  Forguidanceonoutofrangeresults,pleasefollowyourorganisaAonalpolicy

Lowbloodglucoseresults•  AresultfallingoutsidetherangesetbyyourorganisaAonwill

requiresomeintervenAonfromtheoperator,suchasrepeaAngthetest–  Themeterwilldisplayasolidredarrow

•  Forguidanceonoutofrangeresults,pleasefollowyourorganisaAonalpolicy

DisplayMessages

Result is higher than or equal to 13.3 mmol/L

Glucose result is above 27.8 mmol/L

Result is less than 1.1 mmol/L

Results&Memory

Thetestiscompletewhentheresultappearsonthemeterscreen.• Theresultisstoredinthemeter’slogbook• Themeterlogbookcanstoreupto1,000events–includingbloodglucose,bloodketone,andcontrolsoluAonresults,andothermeterinformaAon• ThelogbookcanbeaccessedbygoingtotheHomeScreenandselecAng• TorecallpaAentresults:WiththeFreeStyleOpAumNeoHturnedon:

1.  Pressthe toviewlogbookevents2.  Press or toscrollthroughlogbookevents

While on the Home screen, press to view logbook events

Logbook:ViewLogbookEvents

Press to scroll through to view logbook events

Blood Glucose Result

Glucose Control Solution Result

Blood Ketone Result Venous Blood Result

Ketone Control Solution Result

Control solution test results will alternate between ‘CtL’ and result

Logbook:ViewBloodGlucoseAverages

Average

Number of tests In this average

1. While in the logbook, press any time to view the 7-day average

2. Press or to scroll through 7-, 14- and 30-day averages. Press to return to logbook events.

ErrorMessages

Message What it means

E1 Temperature is too hot or too cold for the meter to work correctly

E2/E9 Meter error

E3 i.  Blood drop is too small

ii.  Incorrect test procedure

iii.  There may be a problem with the test strip

E4 i.  The blood glucose level may be too high to be read by the system

ii.  There may be a problem with the test strip

E5 i.  Blood was applied to the test strip too soon

E6 i.  Calibration error

ii.  Test strip error

E7 i.  Test strip may be damaged, used or the meter does not recognise it

PerformingaQualityControlTest

PerformingaQualityControlTest

•  IfQCtesAngisNOTperformed,misleadingresultsmayleadtoinappropriatetreatment

•  AlwaysfollowyourorganisaAonalpolicytoavoidpumngpaAentsatrisk•  TheFreeStyleOpAumNeoHmetermaypromptwhenthisisdue•  OnlyuseMediSenseGlucoseandKetoneControlSoluAonsandkeepthemeter

flattopreventexcesssoluAonrunningintothemeter•  QCSoluAonisstablefor90daysfollowingopeningorunAltheexpirydate

printedonthesoluAonbohles,whicheverissooner.DiscardanddoNOTusecontrolsoluAonpastitsexpirydate

•  CheckresultsagainsttheteststripinsertinsidethepackofteststripsbeingusedasQCrangeswillvarybetweenteststripLOTs

•  ItistheresponsibilityofalluserstoensurethemeterhasbeentestedbeforepaAentuse

PerformingQualityControl(QC)Tests1.  CheckthattheLOTnumberprintedontheteststripandinstrucAonsforuse

match2.  Opentheindividualfoilteststripatthenotchandteardown3.  Inserttheteststripintothemeterwhichwillturnthemeteronturnon4.  WhentheblinkspressthebuhonunAlthisiconappears5.  ThemeterisnowreadyforyoutoapplythelowlevelcontrolsoluAontothetest

stripi.  InvertthebohletomixthesoluAonii.  WipetheQCnozzlewithcleangauzebeforeandafereachtestiii.  Replacethecapsecurelyonthebohleimmediatelyaferuse

7.  ApplyadropofthecontrolsoluAonwiththemeterinahorizontalposiAontoavoiditenteringtheteststripport

PerformingQualityControl(QC)Tests8.  ApplyadropofthecontrolsoluAontotheteststripunAl3shortlinesappearon

thescreen9.  Theresultswillbedisplayedafera5-secondcountdown

i.  ComparethecontrolsoluAonresultstotherangeprintedonthebloodglucoseteststripinsert; theresultsshouldfallwithinthisrangei.  TheresultswillbestoredinmemoryasacontrolsoluAonresultii.  RecordtheresultintheQCrecordbook

10.  Ifresultsareout-of-rangei.  Repeatthetestii.  Iftherepeatedresultisout-of-rangefolloworganisaAonalpolicyforout-of-rangeresults

11.  Removetheteststrip,repeattheprocedureforhighlevelcontrolsoluAon12.  RecordHIandLOQCtestresultintheQCrecordbook

QualityControlTesAngSummary

1.  Insertteststrip,blinks.

2.PressandholdtheunAlappears.

3.ThemeterisnowreadyfortheoperatortoapplycontrolsoluAontotheteststrip.

4.ApplycontrolsoluAon.5.Sampledetected,countdown

begins.5.Resultisdisplayed.

Maintenance

Maintenanceofthemeter

1.  GentlycleantheexterioroftheFreeStyleOpAumNeoHmeterwithadampclothi.  AcceptablecleaningsoluAonsincludemilddetergentandwater,70%isopropylalcohol

oramixtureof1parthouseholdbleachand9partswaterii.  Donotimmersethemeterinwaterorotherliquids.Avoidgemngdust,blood,control

soluAonandanyothersubstancesintheteststripport,USBportandbaherycompartment

iii.  Allowthemetertodry

2.  Donottrytocleantheteststripport.3.  Donotpourliquidintotheteststripportorontothebuhons.4.  Donotimmersethemeterinwateroranyotherliquid.

Maintenanceofthemeter1.  Replacecoincellbaherieswhen‘LowBaheryPower’messageisdisplayed

1.  Themeterrequires2replaceableCR2032coincellbaheries.2.  Tochangethebaheriesturnthemeteroverandslidethebaherydoor

(locatedonthesideofthedevice)open,asshown.2.  PerformQCtestasperorganisaAonalpolicy3.  RefertotroubleshooAngguideinFreeStyleOpAumNeoHoperator’smanualfor

errormessages4.  Whennotinuse,alwaysstoretheFreeStyleOpAumNeoHmeterasper

organisaAonalpolicy

Bloodβ-KetoneTes+ngwithFreeStyleOp+umNeoH

The FreeStyle Optium Neo H system enables easy and accurate bedside testing of blood ketone levels

} 10 second test time

} 1.5 μL sample size

} Purple calibrator calibrates the meter

} Control solution mark

Blood ketone testing

AnIntroduc+ontoFreeStyleOp+umNeoH

TheFreeStyleOpAumNeoHSystemataGlance

High contrast display Displays meter home screen, test results

and other important information

Up button •  Use to mark a venous blood test

•  Adjust settings

Test strip port Where the test strip is inserted

Down button •  Used to mark a control solution test

•  Adjust settings

Power button Press to:

•  Turns meter on and off

•  Returns to the home screen

•  Saves settings

USB port Insert a data cable for uploading test results to a computer

FreeStyle Optium H Blood β-Ketone Test Strips

TheFreeStyleOpAumHBloodβ-KetoneTestStrip:• 1.5μLsamplesize• 10-secondresultcountdown• AssayRange0.0-8.0mmol/L• HaematocritRange30-60%• ToporApsampleapplicaAon• VisualconfirmaAonofsufficientsample• Filltriggerensuressufficientsample• SampleType–capillary(finger)andvenouswholebloodsamples• Eachpackcontains10individuallyfoilwrappedteststrips,calibraAonbarandteststripinsert

β-Ketone Benefits

Clinicalaccuracy• Measuresβ-hydroxybutyrate(themostsignificantketonebody)• AquanAtaAvevs.qualitaAvemeasure• ResultsunaffectedbymanycommonmedicaAons

Pa+entconvenience/compliance• Bloodvs.urinesampling• Foilwrappedteststrips• Testintegratedwithinbloodglucosemeters

MetercalibraAon

•  ThecalibraAonprocedureprogrammesthemeterwiththelotnumber,expirydateandteststriptechnology

•  Alwayscalibratethemeterwitheachnewpackofteststrips–failuretocalibrateproperlywillcauseincorrectresults

•  Withthelotnumberfacingtowardyou,insertthecontactbarsofthecalibratorintothemeter.ThemeterturnsonautomaAcally

•  LOTandthelotnumberappearinthedisplaywindow•  Checkthatthelotnumberonthemeterdisplaywindowmatches

withthenumberontheteststripcalibratorandthelastfivedigitsonboththeteststripfoilpacketandteststripinsert

•  RetainthecalibraAonbarfortheduraAonofthatpack•  CalibraAoniscomplete•  Onlyusethecalibratorthatispackagedinthepackofteststrips

youareusing

PerformingaPa+entTest

PaAentTesAng1.  Preparethesamplesite:

i.  Beforeyouobtainablooddrop,makesurethesamplesiteisclean,dryandwarm

ii.  Hangthearmdownbeforelancingthesamplesite,tohelpaidbloodflow

2.  Opentheindividuallyfoilwrappedteststripatthenotchandteardown

3.  InserttheteststripintothemeterunAlitstops.Thiswillturnthemeteron.

4.  CheckthattheLOTnumberofteststripyouareusingmatchestheLOTnumbershownonthemeterdisplay

5.  The blinks,indicaAngthemeterisreadyforyoutoapplyasampletotheteststripi.  EnsureyoufolloworganisaAonalpolicyforsamplecollecAon

PaAenttesAng

6.  IftesAngketonesonvenousbloodpressthetomarkthetestunAlappearsindicaAngthatthemeterisnowreadyforyoutoapplyvenousbloodtotheteststrip7.  Applyasamplewiththemeterinahorizontal(flat) posiAontoavoiditenteringtheteststripport8.  Ifyouareapplyingthesamplefromasyringe,applyaway

fromthedirecAonoftheteststripport

PaAenttesAng

9.  HoldsampletotheteststripunAl3shortlinesappearonthescreen

10.  Theresultswillbedisplayedafera10-secondcountdown

PaAenttesAng

Whentheresultappearsonthemeterscreenthetestiscomplete.Theresultswillbestoredinthemeter’smemory.Pressandholdthebuhontoturnoffthemeter.

DisplayMessages

Message Explanation

Result above 8.0 mmol/L

Thisappearswhenaresultishigherthan8.0mmol/LThissuggestsveryhighbloodketonelevelsorthattheremaybeanerrorwiththeteststripRepeatthetestwithanewteststripThisrequiresimmediateacAonasdefinedbyyourfacility’spoliciesandprocedures

1.  Insert ketone test strip, blinks and KET appears

2.  Apply blood

3. Sample detected, 10 seconds countdown begins

4. Result is displayed

Blood Ketone Testing summary

ErrorMessages

Message What it means

E1 Temperature is too hot or too cold for the meter to work correctly

E2/E9 Meter error

E3 i.  Blood drop is too small

ii.  Incorrect test procedure

iii.  There may be a problem with the test strip

E4 i.  The blood glucose level may be too high to be read by the system

ii.  There may be a problem with the test strip

E5 i.  Blood was applied to the test strip too soon

E6 i.  Calibration error

ii.  Test strip error

E7 i.  Test strip may be damaged, used or the meter does not recognise it

PerformingaQualityControlTest

PerformingaQualityControlTest

•  IfQCtesAngisNOTperformed,misleadingresultsmayleadtoinappropriatetreatment

•  AlwaysfollowyourorganisaAonalpolicytoavoidpumngpaAentsatrisk•  TheFreeStyleOpAumNeoHmetermaypromptwhenthisisdue•  OnlyuseMediSenseGlucoseandKetoneControlSoluAonsandkeepthemeter

flattopreventexcesssoluAonrunningintothemeter•  QCSoluAonisstablefor90daysfollowingopeningorunAltheexpirydate

printedonthesoluAonbohles,whicheverissooner.DiscardanddoNOTusecontrolsoluAonpastitsexpirydate

•  CheckresultsagainsttheteststripinsertinsidethepackofteststripsbeingusedasQCrangeswillvarybetweenteststripLOTs

•  ItistheresponsibilityofalluserstoensurethemeterhasbeentestedbeforepaAentuse

PerformingQualityControl(QC)Tests1.  CheckthattheLOTnumberprintedontheteststripandinstrucAonsforusematch2.  Opentheindividualfoilteststripatthenotchandteardown3.  Inserttheteststripintothemeterwhichwillturnthemeteronturnon4.  WhentheblinkspressthebuhonunAlthisiconappears5.  ThemeterisnowreadyforyoutoapplythelowlevelcontrolsoluAontothetest

stripi.  InvertthebohletomixthesoluAonii.  WipetheQCnozzlewithcleangauzebeforeandafereachtestiii.  Replacethecapsecurelyonthebohleimmediatelyaferuse

7.  ApplyadropofthecontrolsoluAonwiththemeterinahorizontalposiAontoavoiditenteringtheteststripport*KETwillappearonthescreenasapurpleketoneteststriphasbeeninserted

PerformingQualityControl(QC)Tests8.  ApplyadropofthecontrolsoluAontotheteststripunAl3shortlinesappearon

thescreen9.  Theresultswillbedisplayedafera10-secondcountdown

i.  ComparethecontrolsoluAonresultstotherangeprintedonthebloodglucoseteststripinsert; theresultsshouldfallwithinthisrangei.  TheresultswillbestoredinmemoryasacontrolsoluAonresultii.  RecordtheresultintheQCrecordbook

10.  Ifresultsareout-of-rangei.  Repeatthetestii.  Iftherepeatedresultisout-of-rangefolloworganisaAonalpolicyforout-of-rangeresults

11.  Removetheteststrip,repeattheprocedureforhighlevelcontrolsoluAon12.  RecordHIandLOQCtestresultintheQCrecordbook

QualityControlTesAngSummary

1.  Insertteststrip,blinks.

2.PressandholdtheunAlappears.

3.ThemeterisnowreadyfortheoperatortoapplycontrolsoluAontotheteststrip.

4.ApplycontrolsoluAon.5.Sampledetected,countdown

begins.5.Resultisdisplayed.

Maintenance

Maintenanceofthemeter

1.  GentlycleantheexterioroftheFreeStyleOpAumNeoHmeterwithadampclothi.  AcceptablecleaningsoluAonsincludemilddetergentandwater,70%isopropylalcohol

oramixtureof1parthouseholdbleachand9partswaterii.  Donotimmersethemeterinwaterorotherliquids.Avoidgemngdust,blood,control

soluAonandanyothersubstancesintheteststripport,USBportandbaherycompartment

iii.  Allowthemetertodry

2.  Donottrytocleantheteststripport.3.  Donotpourliquidintotheteststripportorontothebuhons.4.  Donotimmersethemeterinwateroranyotherliquid.

Maintenanceofthemeter1.  Replacecoincellbaherieswhen‘LowBaheryPower’messageisdisplayed

1.  Themeterrequires2replaceableCR2032coincellbaheries.2.  Tochangethebaheriesturnthemeteroverandslidethebaherydoor

(locatedonthesideofthedevice)open,asshown.2.  PerformQCtestasperorganisaAonalpolicy3.  RefertotroubleshooAngguideinFreeStyleOpAumNeoHoperator’smanualfor

errormessages4.  Whennotinuse,alwaysstoretheFreeStyleOpAumNeoHmeterasper

organisaAonalpolicy

CongratulaAonsoncompleAngthismodule

FreeStyle blood glucose meters assist in the monitoring of blood glucose (and ketone) levels for people diagnosed with diabetes mellitus. People diagnosed with diabetes with elevated blood ketone levels should seek medical advice. Information contained herein for distribution outside of the U.S. Only. FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. All other trademarks are the property of their respective owners. Abbott Diabetes Care Australia, 666 Doncaster Road, Doncaster VIC 3180. For further information call Customer Service on 1800 801 478 or visit www.myfreestyle.com.au MSE160420044321