abbott pediatric product testing program

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Lancing Device User Experience Kids with diabetes ages 12 to 17 are invited to participate in a lancing device user experience study involving a new lancing device. You'll need parental permission and will meet for 15 minutes on Tuesday, July 7th and for 30 minutes on Friday, July 10th. Monetary compensation will be provided after the final meeting. For more information, contact [email protected] starts today! @ El Paso I – from 8:00 AM to 8:00 PM

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Page 1: Abbott Pediatric Product Testing Program

Lancing Device User Experience

Kids with diabetes ages 12 to 17 are invited to participate in a lancing device user experience study involving a new lancing device. You'll need parental permission and will meet for 15 minutes on Tuesday, July 7th and for 30 minutes on Friday, July 10th. Monetary compensation will be provided after the final meeting. For more information, contact [email protected]

starts

today!

@ El Paso

I – fro

m

8:00 AM to 8:00 PM

Page 2: Abbott Pediatric Product Testing Program

PLEASE FOLLOW THESE INSTRUCTIONS CAREFULLY

Page 3: Abbott Pediatric Product Testing Program

STEP 1: ERemove cap

Pull off the attached cap and set aside. Do not twist.

STEP 2: EInsert new lancet

Hold the lancet by the sterility tab and push the lancet into the open end of the device until it snaps into place.

STEP 3: ETwist off sterility tab Twist the sterility tab one full turn and pull it off to remove.

STEP 4: ERe-attach finger cap Align the cap against the lancing device and snap into place.

Lancing Device User InstructionsEXCLUSIVELY FOR MARKET RESEARCH STUDY

STEP 5: Adjust depth setting Adjust slider to set the depth of the lancet needle. Push forward to allow for a deeper setting and return slider for a shallow setting.

STEP 6: Pull charging handle Pull the charging handle forward to arm the device.

STEP 7: Press release button

Hold the device steady on the surface of the skin with light pressure. Press the release button.

STEP 8: Eject used lancet

Remove the cap and push the eject slider forward with your index finger to detach the lancet from the device. Dispose used lancet in a safe receptacle.

F

F

F

F

Release EButton

F Finger Cap

F Eject Slider

Depth EAdjust

Charging EHandle

CAUTIONUse the test lancing Device only •with the included lancets. This is a single person use only •device. NEVER use the same lancet to obtain blood samples from different people.Device is for self-use only •and is not intended for use by healthcare and care workers.Do not use a lancet if it appears •damaged or if the sterility tab is missing.Do not reuse lancets.•Used lancets should be •disposed of safely in a puncture resistant container.If you need to dispose of the •lancing device, dispose of it carefully to prevent contamination to others.Small components are potential •choking hazards.

INFORMATIONLancets sterilized by irradiation.•

CLEANING & CARECleanliness of your lancing device is important to help prevent contamina-tion or risk of infection:

The cap may be removed and •cleaned with isopropyl alcohol or soap and water.The device may be cleaned with •a damp cloth and mild soap.Do not immerse device in liquid.•Store at -25°C to 60°C.

Do Not Reuse

Page 4: Abbott Pediatric Product Testing Program

First name Age

Lancing Device User Experience

Page 5: Abbott Pediatric Product Testing Program

Market Research Study Instructions: Test with this lancing device a minimum of 5 times per day Tuesday, Wednesday, and on Thursday, for a minimum of 15 lancing episodes.

• Atleast3successfullancingdevicetests shouldbeconducteddailyusingyourexisting glucosemetersystemonyourusualtestsites (fingersoralternativesites,asinstructedby yourphysician).Weconsiderasuccessful lancingtest,atestwhereyoutransferthe glucosetestresultfromyourmetertothis logbook.

• Pleaseensureyoudiscardthelancetafter eachlancing,asweareinterestedin

Page 6: Abbott Pediatric Product Testing Program

learningaboutyourexperiencefromausability standpoint.

• Weaskthatyouusethesuppliedlancingdevice duringtherespectivetestperiods,andthatyou putyourcurrentlancingdeviceasideuntilthe completionofthisstudy.

• Usethelancingdevicelogbooktorecordthe eventsandresultsfromyourassignedlancing device,alongwithdate,answeringallques- tionsalongwithanyadditionalcomments.

Please use a black or blue pen to complete this log book. If you have any questions or experience any difficulty using your test supplies, please contact Mobile: 781-354-0554 or 510-206-4907. If you have any issues related to the performance of your glucose monitoring device, please contact the manufacturer directly.

Page 7: Abbott Pediatric Product Testing Program

Lancet Instructions:

IMPORTANT:• Donotuseiftheprotective capismissingordamaged.• Disposeofresponsibly.

Distributedby:AbbottDiabetesCareInc.1360SouthLoopRd.Alameda,CA945021-888-522-5226www.abbottdiabetescare.com©2006-2008Abbott

ART16592Rev.A10/08

Do Not Reuse

DO NOT USE IF TOP OR BOTTOM SEAL IS MISSING OR BROKEN.

Initial here

Page 8: Abbott Pediatric Product Testing Program

Day DatePain Score

If there was enough blood and you got a glucose result, please rate the pain by checking the corresponding rating:

Pain Rating

1 – Completely Painless

2 – Virtually Painless

3 – Slight Pain

4 – Moderate Pain

5 – Severe Pain

Did you experience an accidental finger stick:

Yes / No(Please circle)

Lance Site Depth Setting

Finger

Arm

Other

(If checked “Other” please write lance site location above)

Results

No blood

Not enough blood

Glucose results

(mg/dL)

(Please enter a check mark, indicating outcome of lancing event)

X X X

105 0

SA

MP

LE

Page 9: Abbott Pediatric Product Testing Program

Day DatePain Score

If there was enough blood and you got a glucose result, please rate the pain by checking the corresponding rating:

Pain Rating

1 – Completely Painless

2 – Virtually Painless

3 – Slight Pain

4 – Moderate Pain

5 – Severe Pain

Did you experience an accidental finger stick:

Yes / No(Please circle)

Lance Site Depth Setting

Finger

Arm

Other

(If checked “Other” please write lance site location above)

Results

No blood

Not enough blood

Glucose results

(mg/dL)

(Please enter a check mark, indicating outcome of lancing event)

Page 10: Abbott Pediatric Product Testing Program

Day DatePain Score

If there was enough blood and you got a glucose result, please rate the pain by checking the corresponding rating:

Pain Rating

1 – Completely Painless

2 – Virtually Painless

3 – Slight Pain

4 – Moderate Pain

5 – Severe Pain

Did you experience an accidental finger stick:

Yes / No(Please circle)

Lance Site Depth Setting

Finger

Arm

Other

(If checked “Other” please write lance site location above)

Results

No blood

Not enough blood

Glucose results

(mg/dL)

(Please enter a check mark, indicating outcome of lancing event)

Page 11: Abbott Pediatric Product Testing Program

Day DatePain Score

If there was enough blood and you got a glucose result, please rate the pain by checking the corresponding rating:

Pain Rating

1 – Completely Painless

2 – Virtually Painless

3 – Slight Pain

4 – Moderate Pain

5 – Severe Pain

Did you experience an accidental finger stick:

Yes / No(Please circle)

Lance Site Depth Setting

Finger

Arm

Other

(If checked “Other” please write lance site location above)

Results

No blood

Not enough blood

Glucose results

(mg/dL)

(Please enter a check mark, indicating outcome of lancing event)

Page 12: Abbott Pediatric Product Testing Program

Day DatePain Score

If there was enough blood and you got a glucose result, please rate the pain by checking the corresponding rating:

Pain Rating

1 – Completely Painless

2 – Virtually Painless

3 – Slight Pain

4 – Moderate Pain

5 – Severe Pain

Did you experience an accidental finger stick:

Yes / No(Please circle)

Lance Site Depth Setting

Finger

Arm

Other

(If checked “Other” please write lance site location above)

Results

No blood

Not enough blood

Glucose results

(mg/dL)

(Please enter a check mark, indicating outcome of lancing event)

Page 13: Abbott Pediatric Product Testing Program

If this log book is lost, please call Mobile: 781-354-0554 or 510-206-4907. Thanks for your assistance.

Please remember your appointment for Friday, July 10th between 8 AM – 8 PM in the El Paso I meeting room, where we want to know about your lancing device experience.

Reserve your time beforehand, so you don’t have to wait in line!!!

Don’tForget!

Reserve your follow-up

appointment