optium user manual

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Users Manual

FreeStyleand otherbrandmarksaretrademarksof AbbottDiabetesCareInc.in variousjurisdictions.2010 Abbott

ART20287 Rev.A 11/10

Blood Glucose Monitoring System

Abbott Diabetes Care666 Doncaster RoadDoncaster 3108Victoria, AustraliaABN 95000 180 3891800-801-478

Abbott Laboratories (M) Sdn BhdAbbott Diabetes CareNo.22,Jalan Pemaju U1/15,HICOM-Glenmarie Ind.Park

40150 Shah Alam, SelangorMalaysia03-5569-1919

Abbott Laboratories (N. Z.) Ltd,Ground Floor Bldg. D, 4 Pacific Rise,Mount Wellington, P.O. Box 22-801 Otahuhu,Auckland, New Zealand0800 106 100

Abbott Laboratories Pakistan Ltd.Abbott Diabetes CareOpposite Radio Pakistan Transmission,Hyderabad Road, LandhiKarachi, Pakistan

021-35100321

Abbott Laboratories (Singapore) Pte LtdAbbott Diabetes Care1 Maritime Square #12-09Harbour Front CentreSingapore 0992531800-272-2881

National Phytopharma Joint-Stock Company24 Nguyen Thi Nghia, District 1Ho Chi Minh CityVietnam08-910-6640 ext 849

Abbott LaboratoriesAbbott Diabetes Care102 E.De Los Santos Ave.Madison Street1554 Mandaluyong, Metro Manila

Philippines02-702857702-7028578

ART20287_Rev-A-Cvr.indd 1-2 11/17/10 2:40 PM

DO NOT PRINT FROM THIS FILE -

FOR REFERENCE ONLY


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Deinition o Symbols

These symbols are associated with your meter.

Batch codeThe European Battery Directive requires separatecollection o spent batteries, aiming to acilitaterecycling and to protect the environment. Thebatteries in this product should be removed anddisposed in accordance with local regulations orseparate collection o spent batteries.

Catalogue number

Caution This packaging is capable o being recycled

Consult instructions or use Manuacturer

Date o manuacture Sterilised using irradiation (lancets only)

Do not drink Temperature limitation

Do not reuse Use by

In vitro diagnostic medicaldevice

Serial number

ART20287_Rev-A-Man.indd 1 11/17/10 3:01 PM

DO NOT PRINT FROM THIS FILE -

FOR REFERENCE ONLY


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Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Monitoring System Kit Contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Setting Up the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Enter Setup Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Beeper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Time Format.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Date Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Measurement Units. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Testing Your Blood Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Important Testing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Test Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8

Alternative Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Perorming a Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Understanding Blood Glucose Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Lo w a nd H igh B lo od G lu co se Re su lt s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Testing Your Blood -Ketone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Important Testing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Test Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Pe ro rmi ng a Bl ood -K et on e Te st . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Understanding Blood -Ketone Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

H igh Blood -Ketone Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Table o ContentsMediSense or Optium Glucose and Ketone Control Solutions . . . . . . . . . . . . . .23

Important Control Solution Testing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Perorming a Control Solution Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Managing Your Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Viewi ng Test R esults i n M emor y. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

V i e w i n g B l o o d G l u c o s e A v e r a g e s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Transerring Results to a Computer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

E-1 to E-9, What It Means, What To Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Maintaining the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

R e p l a c i n g t h e B a t t e r y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Cleaning the Meter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Storing the Meter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Specifcations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Reerences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

ART20287_Rev-A-Man.indd 2-3 11/17/10 3:01 PM


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Intended Use

Use outside the body only (in vitro diagnostic use) or sel testing or proessional use in themanagement o diabetes.

Use or measuring blood glucose rom samples taken rom the orearm, upper arm, base o thethumb, or ngers.

Test blood glucose in resh whole blood samples

Test blood -Ketone (-hydroxybutyrate) in resh whole blood samples rom ngers only

IMPORTANT: Use only FreeStyle Optium blood glucose test strips

and FreeStyle Optium blood -Ketone test strips. Other test stripsmay produce inaccurate results.

IMPORTANT: See test strip instructions or use or more inormation about sampletypes.

Potential inection risk: Healthcare proessionals perorming blood tests with thissystem on multiple patients must always wear gloves and should ollow the inectioncontrol policies and procedures approved by their acility.

Read the instructions in this users manual. Failure to ollow instructions will causeincorrect results. Practise the testing procedures beore using the meter. Followyour healthcare proessionals advice when testing blood glucose levels and blood-Ketone levels.

Observe caution when using around children. Small parts may constitute a choking

hazard.

How Your FreeStyle Optium Blood Glucose Monitoring System WorksWhen you insert a test strip into your meter, the Apply Sample message shows on your meters displaywindow. When a blood sample or control solution sample is applied to the test strip, the glucose or-Ketone reacts with the chemicals on the test strip. This reaction produces a small electrical currentthat is measured. The result shows on your meters display window.

IMPORTANT: Avoid getting dust, dirt, blood, control solution, water orany other substance in the meters test strip port.

1



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Monitoring System Kit Contents

Monitoring System Kit contains:

Meter

Users Manual

Carrying Case

Logbook

Warranty Card

Your Kit may also contain:

Blood Glucose Test Strips

Lancing Device

Lancets

Items not included:

Blood -Ketone Test Strips

Control Solutions

Data Management System

Setting Up the Meter

Enter Setup Mode

Start with the meter o (no teststrip inserted).

Press and hold until and appear. This indicates the beeper is turned on.

and indicate the beeper is turned o.

Beeper

Press or to change the beeper setting.Press to save the beeper setting and moveto set time.

Commands

Press to move between setup displays

Press to move orward

Press to go back

Press to turn display light On and O

The beeper sounds when:

The test countdown starts

The test countdown ends



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Time

The hour fashes. Press or until the correct hour appears. Press to savethe hour and to move to set minutes.

The minutes fash. Press or until the correct minutes appear. Press tosave the minutes and to move to set date.

Date

YearThe year fashes. Press or until the correct year appears. Press to save theyear and to move to set month.

The month fashes. Press or until the correct month appears. Press tosave the month and to move to set day.

The day fashes. Press or until the correct day appears. Press to save theday and to move to set time ormat.Month Day

Time Format

24 Hour Format

Note: I using the 12-hour ti me ormat, AM and PM appear.

The time ormat fashes. Press or to change the time ormat. Press tosave the time ormat and to move to set date ormat.

Date Format

Month Day

The date ormat fashes. Press or to change the date ormat. Press tosave the date ormat and to move to the measurement units.

Day.Month

Measurement Units

The unit o measurement set by the actory appears. You cannot change thissetting. Contact Customer Service or more inormation.

Press to return to set beeper, or press and hold to turn o the meter.

IMPORTANT:Please check that the correct time and date is set beoreyou use the meter or the rst time. This will help you keep records owhen you monitor and will help you and your healthcare proessionalmake inormed decisions about your care. You must set the time anddate to review averages.



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Testing Your Blood Glucose

Important Testing Notes

This display always appears when the meter is turned on.You should check that your meter matches the example yousee here exactly every time your meter turns on.

Do not use the meter i the display check screen does notexactly match the example.

I the screen does not match, the meter may show an incorrect

result. Please contact Customer Service.

45001

D5

A138

2012/03

E.g. Expiry date:March 31, 2012

Use the meter within the test strip operating range

Use the test strip immediately ater removing it rom its oil packetUse each test strip only once

45001

D5

A138

2012/03


Donot use expired test strips; they may produce inaccurate results.The expiry date is the last day o the month i only the month and yearare shown.

Donot use a wet, bent, scratched or damaged test strip.

Donotuse the test strip i its oil packet has a puncture or tear in it.

Note: See test strip instructions or use or operating range and more inormationon limitations o use.

Test Site

Fingertips

Note: Avoid areas near bones, areas with lots o hair, and squeezing the puncture site.Bruising may occur at alternate sites, but will disappear quickly. I bruising occurs,consider selecting another site.

Finger tip testing is dierent to alternative site testing. (Adjust the lancing deviceaccordingly or testing site. See lancing device instructions or use or moreinormation.)

IMPORTANT:Wash your hands and the test site with warm soapywater to ensure accurate results. Thoroughly dry your hands and thetest site. To warm the site, apply a warm dry pad or rub vigorously or aew seconds.



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Alternative Sites

2

Base o thumb

2

Upper arm

2

Forearm

Obtaining a blood sample rom alternative sites orearm, upper arm, and base othe thumb is subject to limitation. Contact your healthcare proessional beorebeginning alternative site testing.

Alternative site results may dier rom ngertip results when blood glucoselevels change rapidly (e.g. ater eating a meal or taking insulin, or during orater exercise)

Use alternative sites beore, or more than two hours ater, you eat a meal, takeinsulin, or exercise

Do not use blood samples rom alternative sites when:

You think your blood glucose is low or changing rapidly

You have been diagnosed with hypoglycaemic unawareness

Alternative site results do not match the way you eel

You are within two hours o eating a meal, taking insulin, or exercising

Perorming a Blood Glucose Test

AbbottDiabetesCareLtd.

RangeRoad

Witney,Oxon,OX290YL

MadeinUK.

BloodGlucose

SensorElectrode


RangeRoad

itney,Oxon,OX290YL

adeinUK.

4 C

Open the oil test strip packet at the notch and tear down to remove thetest strip.

Insert the Test Strip

With the contact bars (3 black lines) acing up, insert the test strip into the meteruntil it stops. This turns on the meter.

Note: The meter turns o ater 3 minutes o inactivity. Remove and reinsert the unusedtest strip to restart the meter.

This display always appears when the meter is turned on.

Do not use the meter i the display check screen does not exactly match theexample. Contact Customer Service.

See Testing Your Blood Glucose section or more inormation.

Time and date (i set) appear next.



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The Apply Sample symbols and appear next, indicating the meter is ready or

you to apply a sample to the test strip.

2

Obtain a Blood Sample

Select a test site. Use the lancing device to obtain a blood sample. (See lancingdevice instructions or use or more inormation.)

Apply Blood to the Test Strip

Bring the blood drop to the white area at the end o the test strip. The blood isdrawn into the test strip.

IMPORTANT:I the countdown does not start, you may nothave applied enough blood to the test strip. See test stripinstructions or use or re-application instructions. I thecountdown still does not start, remove the used strip anddiscard it correctly. Start a new test with a new test strip.

Hold the blood drop to the white area until the meter beeps (i sound is on) and

the status bar appears on the display. This indicates the test strip has obtainedenough blood.

The countdown appears on the display as the meter checks your glucose level.

Note:Do notremove the test strip rom the meter or disturb the test strip during thecountdown.

View the Result

The meter beeps (i sound is on) when the result appears on the display. The test iscomplete (example shown). The result is stored in memory or you can write it in alogbook.

Turn O the Meter

Use the opened oil packet to remove the used test strip. This turns o the meter.Discard the used test strip correctly.

Note: You can also press and hold or at least 2 seconds to turn o the meter. Themeter also turns o ater 60 seconds o inactivity.



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Understanding Blood Glucose Test Results

Low and High Blood Glucose Results

The meter displays results in mmol/L or mg/dL. The unit o measurement is preset. You cannot changethis setting.

IMPORTANT:The meter displays results rom 1.127.8 mmol/L(20500 mg/dL). Low or high blood glucose results can indicate apotentially serious medical condition.

General:

Result What It Means What To Do

Lower than 2.8 mmol/L(Lower than 50 mg/dL)

Low (hypoglycaemic) Repeat the test with a new test strip, eveni you do not eel that you have low bloodglucose.

Higher than 16.7 mmol/L(Higher than 300 mg/dL)

High (hyperglycaemic) Repeat the test with a new test strip, eveni you do not eel that you have high bloodglucose.

Meter:

Display What It Means What To Do

Appears when result is:Lower than 1.1 mmol/L(Lower than 20 mg/dL))

Severe low bloodglucoseor

There may be a problemwith the test strip

Repeat the test with a new test strip. Ithe result is LO, contact your healthcareproessional immediately.

Appears with resultwhich is:Higher than or equal to16.7 mmol/L(Higher than or equal to300 mg/dL)

Blood glucose level ishigh

Check blood -Ketone, i checking ketonesis part o your diabetes managementprogramme.



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Meter:


Appears when result is:Higher than27.8 mmol/L(Higher than500 mg/dL)

Severe high blood glucose

or


Repeat the test with a new test strip. If theresult is HI, contact your healthcare professionalimmediately.

Check blood -Ketone, if checking ketones is partof your diabetes management programme.

Note:

I you see the error messages E-3 or E-4, consultthe Error Messages section in this users manual.

IMPORTANT:Contact your healthcare proessional i you havesymptoms that do not match your test result, and you have ollowedthe instructions in this users manual.

Testing Your Blood -Ketone

Important Testing Notes

75001

D5

A17

2012/03


Use the meter within the test strip operating range

Use the test strip immediately ater removing it rom the oil packet

Use each test strip only once

Note: See test strip instructions or use or operating range and more inormation onlimitations o use.

Check your ketones:

When you have an illness

When your blood glucose is above 16.7 mmol/L (300 mg/dL)

When you are experiencing unusual blood glucose results

When you and your healthcare proessional eel it is necessary

Donot use expired test strips; they may produce inaccurate results.The expiry date is the last day o the month i only the month andyear are shown.

Donot put urine on the test strip.Do not use a wet, bent, scratched or damaged test strip.

Donot usethe test strip i its oil packet has a puncture or tear in it.



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Test Site

Fingertips

Note: Avoid squeezing the puncture site.

Use only fngertip blood samples or blood -Ketone testing.

Perorming a Blood -Ketone Test


RangeRoad

Witney,Oxon,OX290YL

MadeinUK.

BloodGlucose

SensorElectrode


RangeRoad

itney,Oxon,OX290YL

adeinUK.

4 C

Open the oil test strip packet at the notch and tear down to removethe test strip.


With the contact bars (3 black lines) acing up, insert the test strip into the meteruntil it stops. This turns on the meter.

Note: The meter turns o ater 3 minutes o inactivity. Remove and reinsert the unusedtest strip to restart the meter.

IMPORTANT:Wash your hands with warm soapy water to ensureaccurate results. Thoroughly dry your hands. To warm the site, apply awarm dry pad or rub vigorously or a ew seconds.


Do not use the meter i the display check screen does not exactly match theexample.Contact Customer Service.



and the Apply Sample symbols appear, indicating the meter is

ready or you to apply a sample to the test strip.

2

Obtain a Blood Sample

Select a test site. Use the lancing device to obtain a blood sample. (See lancingdevice instructions or use or more inormation.)



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Apply Blood to the Test Strip

Bring the blood drop to the white area at the end o the test strip. The blood isdrawn into the test strip.

Hold the blood drop to the white area until the meter beeps (i sound is on) and

the status bar appears on the display. This indicates the test strip obtainedenough blood.

The countdown appears on the display as the meter checks your -Ketone level.

Note:Do notremove the test strip rom the meter or disturb the test strip during thecountdown.

IMPORTANT:I the countdown does not start, you may not haveapplied enough blood to the test strip. See test strip instructions oruse or re-application instructions. I the countdown still does notstart, remove the used strip and discard it correctly. Start a new testwith a new test strip.

View the Result

The meter beeps (i sound is on) when the result and appears on thedisplay. The test is complete (example shown). The result is stored in memory oryou can write it in a logbook.

Turn O the Meter


Note: You can also press and hold or at least 2 seconds to turn o the meter. Themeter also turns o ater 60 seconds o inactivity.



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Understanding Blood -Ketone Test Results

High Blood -Ketone Results

The meter displays results in mmol/L. The unit o measurement is preset. You cannot change thissetting.

Blood -Ketone is expected to be below 0.6 mmol/L.2 High blood -Ketone may be caused byillness, asting, vigorous exercise, or uncontrolled blood glucose levels.1-3

Repeat a blood -Ketone test using a new blood -Ketone test strip when:

HI appears on the display

Your result is unusually high

You question your result

Your blood -Ketone result is 0.0 mmol/L, but your blood glucose is higher than 16.7 mmol/L(300 mg/dL)

IMPORTANT:The meter displays results rom 0.0 - 8.0 mmol/L.Consult your healthcare proessional beore changing your diabetesmedication programme.

Meter:


Result is between:0.6 1.5 mmol/L andyour blood glucoseresult is: Higher than16.7 mmol/L(Higher than 300 mg/dL)

High blood -Ketone

A problem requiringmedical assistance maybe occurring

Contact your healthcare proessional orsick-day management instructions.

Result remains:0.6 1.5 mmol/Lor becomes: Higherthan 1.5 mmol/L

You may be at risk odeveloping diabeticketoacidosis (DKA)2-6

Contact your healthcare proessionalimmediately.

Appears when result is:Higher than 8.0 mmol/L

Very high blood-Ketone

or


Repeat the test with a new test strip. Ithe result is HI, contact your healthcareproessional immediately.



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MediSense or Optium Glucose and Ketone Control Solutions

Control solutions may be used with either glucose or -Ketone test strips.Use control solution:

To practise testing without using your own blood

To conrm that the meter and test strips work together correctly

When you are unsure o your blood glucose or blood -Ketone test results

Contact Customer Service or inormation on how to obtain control solutions.

IMPORTANT:When you open a control solution bottle or the rsttime, count orward 90 days and write this date on the controlsolution bottle using a pen that wont smear or wipe o. Throwaway any remaining solution ater this date.

Important Control Solution Testing Notes

Use only MediSense or Optium Glucose and Ketone control solutions with the meter

Replace the cap securely on the bottle immediately ater use

Repeat the test i control solution results are outside this range

Stop using the meter i control solution results are continually outside the range printed on thetest strip instructions or use. Contact Customer Service

Do not use control solution past the expiry date.

Donot add water or other liquid to control solution.

Donot swallow or inject the control solution.

Donot use the control solution as eye drops.

IMPORTANT:Control solution results should all within the controlsolution range printed on the test strip instructions or use. Check thatthe lot number printed on the test strip packet and instructions oruse match.

IMPORTANT:Control solution results do not refect your bloodglucose or blood -Ketone level.


P i C l S l i T


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Perorming a Control Solution Test


RangeRoad

Witney,Oxon,O

X290YL

MadeinUK.

BloodGlucose

SensorElectrode


RangeRoad

itney,Oxon,OX290YL

adeinUK.

4 C

Open the oil test strip packet at the notch and tear down to remove thetest strip.


With the contact bars (3 black lines) acing up, insert the test strip into the meter

until it stops. This turns on the meter.

Note: The meter turns o ater 3 minutes o inactivity. Remove and reinsert theunused test strip to restart the meter.





The Apply Sample symbols and also appear.

Note: and will appear i perorming a -Ketone control solutiontest.

Press to mark the test as a control solution test.

The appears. The meter is now ready or you to apply control solution to thetest strip.

Apply Control Solution to the Test Strip

Shake the control solution bottle to mix the solution. Apply a drop o controlsolution to the white area at the end o the test strip in the area shown. The controlsolution is drawn into the test strip.

Hold the control solution drop to the white area until the meter beeps (i soundis on) and the status bar appears on the display. This indicates the test strip hasobtained enough control solution.

IMPORTANT:The test result will be saved to memory as a bloodglucose or blood -Ketone result i not marked as a control solutiontest. This may aect your blood glucose averages.



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The countdown appears on the display as the meter checks the glucose or-Ketone level.

Note: Do notremove the test strip rom the meter or disturb the test strip during thecountdown.

I the countdown does not start, remove and discard the used test strip, turn othe meter and try again with a new strip.

View the Result

The meter beeps (i sound is on) when the result appears on the display. The testis complete (examples shown). The result is stored in memory as a control solutionresult or you can write it in a logbook as a control result.

Note: appears with the result i perorming a -Ketone control solutiontest.

Compare the control solution result to the range printed on the blood glucose orblood -Ketone test strip instructions or use. The result should all within the range.

Causes o out-o-range results include:

The meter and test strips may not be working correctly

Repeat the test with a new test strip. Follow the testing instructions careully.Contact Customer Service i the result is still outside the printed range.

Turn O the Meter


Note: You can also press and hold or at least 2 seconds to turn o the meter. The

meter also turns o ater 60 seconds o inactivity.


M i Y R lt


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Managing Your Results

Meter memory stores up to 450 events control solution, blood glucose, and blood -Ketone results,and other meter inormation. The most recent events appear rst.

Viewing Test Results in Memory

Start with the meter o (no test strip inserted).

Press to turn the meter on.




Your most recent result, with time and date (i set) it was obtained, appears next.The ollowing symbols indicate the type o result:

= Blood glucose result

= Blood -Ketone result

= Glucose control solution result

= Ketone control solution result

Press to review the previous result. Repeat this or each result you wishto review.

Note: To exit meter memory at any time, press and hold .

Appear on the display when there are no previous results to view.

Press to return to a previously reviewed result. Repeat this or each result youwish to review.

Note: To exit meter memory at any time, press and hold .


Viewing Blood Glucose Averages


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Viewing Blood Glucose Averages

IMPORTANT:

Set the date and time beore testing to be able to review averages

Averages do not include glucose and -Ketone control solution results, blood -Ketoneresults, and results that do not show time and date

Control solution results not marked as control solution tests may cause averages to beinaccurate

appear on the display when there are no c urrent averages to view

blood glucose test results appear in averages as 1.1 mmol/L (20 mg/dL)

blood glucose test results appear in averages as 27.8 mmol/L (500 mg/dL)

While in memory, press . Your 7-day average appears.

Note: n = number o results included in your 7-, 14-, or 30-day average.

Press to view the 14-day average.

Press to view the 30-day average.

Press to return to the 7-day average, or

Press to return to the memory screen.

Press and hold to turn o the meter. The meter turns o ater 30 secondso inactivity.


Transerring Results to a Computer

Message What It Means What To Do


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Transerring test results to a computer requires a compatible data management system. For moreinormation, please go to our website or contact Customer Service.

Error Messages

Message What It Means What To Do

The temperature is too hotor too cold or the meter towork correctly

1. Move the meter and test strips to a locationwhere the temperature is within the test stripoperating range. (See test strip instructions oruse or the appropriate range.)

2. Wait or the meter and test strips to adjust tothe new temperature.

3. Repeat the test using a new test strip.4. I the error reappears, contact Customer Service.

Meter error 1. Turn o the meter.2. Repeat the previous testing steps.3. I the error reappears, contact Customer Service.

g

The blood glucose level maybe too low to be read by thesystem

or

There may be a problem withthe test strip

1. Review the testing instructions.2. Repeat the test using a new test strip.3. I the error reappears, contact your healthcare

proessional immediately.

The blood glucose level maybe too high to be read by thesystem

or

There may be a problem withthe test strip

1. Repeat the test using a new test strip.2. I the error reappears, contact your healthcareproessional immediately.

Blood was applied to the teststrip too soon

1. Review the testing instructions.2. Repeat the test using a new test strip.3. I the error reappears, contact Customer Service.


Message What It Means What To Do Troubleshooting


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Meter error 1. Check that you are using the correct strip orthis meter. (See test strip instructions or use toveriy your strip is compatible with this meter.)

2. Repeat the test using a test strip or use withyour meter.

3. I the error reappears, contact Customer Service.

No coding requiredor

Test strip may be damaged,used, or the meter does notrecognise it

1. Check that you are using the correct test strip orthis meter. (See test strip instructions or use toveriy your strip is compatible with this meter.)

2. Repeat the test using a test strip or use withyour meter.

3. I the error reappears, contact Customer Service.

or

Meter error 1. Turn o the meter.2. Repeat the previous testing steps.3. I the error reappears, contact Customer Service.

g

What It Means What To Do

The meterdoes not entertest modeater insertinga test strip.

Test strip is not insertedcorrectly or ully into themeter

1. With the contact bars (3 black lines) acingup, insert the test strip into the meter until itstops. This turns on the meter.

2. I the meter still does not enter test mode,contact Customer Service.

No battery is installed

Battery is installed incorrectly

1. Install battery with (+) acing up.

Dead battery 1. Replace battery. Reset date and time, i necessary.


What It Means What To Do What It Means What To Do


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The test doesnot start aterapplying theblood sample.

Blood sample is too small 1. See test strip instructions or use orre-application instructions.

2. I the countdown still does not start, removethe used strip and discard it correctly.

3. Repeat the test using a new test strip.

4. I the test still does not start, contactCustomer Service.

Sample applied ater meterturns o

1. Remove the used strip and discard itcorrectly.

2. Review the testing instructions.



The test doesnot start aterapplying theblood sample.

Deective meter or test strip 1. Remove the used strip and discard itcorrectly.




Maintaining the Meter 2. I the meter includes a plastic tab, pull on the tab to remove the battery.


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Replacing the Battery

The meter comes with a CR 2032 lithium (coin cell) battery installed. It providespower or about 1,000 tests.

Appears on the display when the battery is low.

Causes the display light to ail to turn on.

When appears, you may still use the meter and the results will be accurate.The display light will not work. Replace the battery immediately.

When appears alone, the meter is not usable. The meter turns oautomatically. Replace the battery immediately.

1. Gently push the battery cover in and up to remove it.

I the meter does not include a plastic tab, push the battery upward toremove it.

3. Insert a new CR 2032, lithium (coin cell) battery: (+) acing up.

4. Slide the battery cover into place until it clicks.

Note: Dispose o used batteries correctly.

5. Press and hold to turn the meter on. I the meter does not turn on, check tosee that the battery was installed correctly.

I meter turns on, the meter may prompt you to reset the time and date.(See Setting Up the Meter in this users manual.)

Note: Test results will be not be lost even i the meter loses its time and datesettings.


Cleaning the Meter

Storing the Meter

Store the meter in the carrying case provided


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Avoid getting dirt, dust, blood, control solution, or liquid in the meter test strip port.

Clean the outside o the meter using a damp cloth and mild soap.

Healthcare Proessionals:

Acceptable cleaning solutions include:

70% isopropyl alcohol, or

A mixture o 1 part ammonia, 9 parts water, or

A mixture o 1 part household bleach, 9 parts water

IMPORTANT:

Donot try to clean the test strip port.

Donot pour liquid into the test strip port or onto the buttons.

Donot immerse the meter in water or other liquid.

Store the meter in the carrying case provided.

Specifcations

Size

Length 7.47 cm

Width Top 5.33 cm

Bottom 4.32 cm

Depth 1.63 cm

Weight 40 to 46 grams

Power Source 1 CR 2032 Lithium (coin cell) battery

Battery Lie Approximately 1,000 tests

MemoryUp to 450 events, including control solution, blood glucose andblood -Ketone results, and other meter inormation.

Storage Temperature

Meter -25 to 55 C (13 to 131 F)


Test strips See test strip instructions or use. Beeper On: When countdown starts and ends.


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C ont ro l s ol uti on Se e control so lu tio n i nst ru ct ions or us e.

Assay Method Amperometric electrochemistry

Assay Range

Blood glucose See blood glucose test strip instruc tions or use.

B lo od -K et one Se e bl oo d - Ke to ne te st st rip instr ucti ons or us e.

Control Solution Range

Blood glucose See blood glucose test strip instruc tions or use.

B lo od -K et one Se e bl oo d - Ke to ne te st st rip instr ucti ons or us e.

Functions

Blood glucose testing

Blood -Ketone testing

Memory 450 events

Glucose averaging 7-, 14-, and 30-day

Control solution markingand testing

Display LightOn: Stays on during countdown; turns o 30 seconds ater results

appear. Stays on while transerring results to a computer.

Data Port Yes

Operating Range

Meter temperature 10 to 50 C (50 to 122 F)

System temperature See operating range o the test strip you are using.

See test strip instructions or use.

Meter relative humidity 10% to 90%, non-condensing

System relative humidity 10% to 90%, non-condensing

System altitudeClinical testing demonstrates that altitudes up to 2,195 metres(7,200 eet) above sea level do not aect results



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Reerences

1. Schade DS, Eaton RP. Metabolic and clinical signicance o ketosis. Special Topics inEndocrinology and Metabolism 1982; 4:127.

2. Wiggam MI, OKane MJ, Harper R, Atkinson AB, Hadden DR, Trimble ER, Bell PM. Treatment odiabetic ketoacidosis using normalization o blood 3-hydroxybutyrate concentration as theendpoint o emergency management. Diabetes Care 1997; 20:13471352.

3. Harano Y, Kosugi K, Hyosu T, Suzuki M, Hidaka H, Kashiwagi A, Uno S, Shigeta Y. Ketone bodies asmarkers or Type 1 (insulin-dependent) diabetes and their value in the monitoring o diabetescontrol. Diabetologia 1984; 26:343-348.

4. Ubukata E. Diurnal variation o blood ketone bodies in insulin-dependent diabetes mellitusand non-insulin-dependent diabetes mellitus patients: The relationship to serum C-peptideimmunoreactivity and ree insulin. Ann Nutr Metab 1990; 34:333342.

5. Luzi L, Barrett EJ, Groop LC, Ferrannini E, DeFronzo RA. Metabolic eects o low-dose insulintherapy on glucose metabolism in diabetic ketoacidosis. Diabetes 1988; 37:14701477.

6. Hale PJ, Crase J, Nattrass M. Metabolic eects o bicarbonate in the treatment o diabeticketoacidosis. Br Med J 1984; 289; 10351038.

7. Directive 1999/45/EC o the European Parliament and o the Council o 31 May 1999 concerningthe approximation o the laws, regulations and administrative provisions o the Member Statesrelating to the classication, packaging and labelling o dangerous preparations.

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