Abbott Pediatric Product Testing Program

s t ! r y a a t s od t

m o r M f P – 0 I 0 : o 8 s a o t P l E AM @ 0 0 : 8

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 lancingdevicestudy@childrenwithdiabetes.com

PLEASE FOLLOW THESE INSTRUCTIONS CAREFULLY

Lancing Device User Instructions EXCLUSIVELY FOR MARKET RESEARCH STUDY

STEP 1: E Remove cap

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

STEP 2: E

Insert new lancet F Finger Cap

Release E Button

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: E

Twist off sterility tab Depth E Adjust

Charging E Handle

Twist the sterility tab one full turn and pull it off to remove.

STEP 4: E F Eject Slider

Re-attach finger cap Align the cap against the lancing device and snap into place.

F 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.

F STEP 6:

Pull charging handle Pull the charging handle forward to arm the device.

F STEP 7:

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

F 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.

CAUTION • Use 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.

INFORMATION • Lancets sterilized by irradiation.

CLEANING & CARE Cleanliness of your lancing device is important to help prevent contamination 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

Lancing Device User Experience First name

Age

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. • At least 3 successful lancing device tests should be conducted daily using your existing glucose meter system on your usual test sites (fingers or alternative sites, as instructed by your physician). We consider a successful lancing test, a test where you transfer the glucose test result from your meter to this log book. • Please ensure you discard the lancet after each lancing, as we are interested in

learning about your experience from a usability standpoint. • We ask that you use the supplied lancing device during the respective test periods, and that you put your current lancing device aside until the completion of this study. • Use the lancing device log book to record the events and results from your assigned lancing device, along with date, answering all ques- tions along with any additional comments.

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.

Lancet Instructions: IMPORTANT: • Do not use if the protective cap is missing or damaged.

• Dispose of responsibly.

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

Distributed by: Abbott Diabetes Care Inc. 1360 South Loop Rd. Alameda, CA 94502 1-888-522-5226 www.abbottdiabetescare.com © 2006-2008 Abbott ART16592 Rev. A 10/08

Do Not Reuse

Initial here

Day

Date

X

X

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

A

Results No blood

E

Other

Pain Rating 1 – Completely Painless

L

Arm

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

P

Finger

Depth Setting

M

Lance Site

2 – Virtually Painless

X

3 – Slight Pain 4 – Moderate Pain

S

Not enough blood

1 05

Glucose results

(mg/dL)

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

5 – Severe Pain

0

Did you experience an accidental finger stick: Yes / No (Please circle)

Day

Date

Lance Site

Depth Setting

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

Finger

Pain Rating

Arm

1 – Completely Painless

Other

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

Results No blood

2 – Virtually Painless 3 – Slight Pain 4 – Moderate Pain

Not enough blood Glucose results

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

5 – Severe Pain Did you experience an accidental finger stick: Yes / No (Please circle)

Day

Date

Lance Site

Depth Setting

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

Finger

Pain Rating

Arm

1 – Completely Painless

Other

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

Results No blood

2 – Virtually Painless 3 – Slight Pain 4 – Moderate Pain

Not enough blood Glucose results

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

5 – Severe Pain Did you experience an accidental finger stick: Yes / No (Please circle)

Day

Date

Lance Site

Depth Setting

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

Finger

Pain Rating

Arm

1 – Completely Painless

Other

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

Results No blood

2 – Virtually Painless 3 – Slight Pain 4 – Moderate Pain

Not enough blood Glucose results

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

5 – Severe Pain Did you experience an accidental finger stick: Yes / No (Please circle)

Day

Date

Lance Site

Depth Setting

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

Finger

Pain Rating

Arm

1 – Completely Painless

Other

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

Results No blood

2 – Virtually Painless 3 – Slight Pain 4 – Moderate Pain

Not enough blood Glucose results

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

5 – Severe Pain Did you experience an accidental finger stick: Yes / No (Please circle)

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!!!

FoDon rg ’t et !

Re se rv ap e yo po ur int fol me low nt -u p

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

Thanks for your assistance.