Accu-Chek Softclix Plus - Manual (Page 2)

ACCU‑CHEK, ACCU‑CHEK COMPACT, and SOFTCLIX
are trademarks of Roche.
M
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu‑chek.com
Manufactured in Germany for:
Roche
9115 Hague Road, Indianapolis, IN 46256, USA
©2010 Roche Diagnostics. All rights reserved.
Getting Blood from a Site Other Than Your Fingertip
Capillary blood for blood sugar testing can be obtained, not only from
the fingertips, but also from other sites (the palm, the forearm, the
upper arm, the calf or the thigh), which is referred to as Alternative
Site Testing (AST). We recommend palm as the non‑fingertip test site.
Use the clear ACCU‑CHEK Softclix Plus AST cap together with the
ACCU‑CHEK Softclix Plus lancing device to collect blood from non‑
fingertip test sites.
Your ACCU‑CHEK Compact Plus system is designed to test blood
glucose also from sites other than your fingertip. Please refer to the
ACCU‑CHEK Compact test strip insert or your ACCU‑CHEK Compact
Plus system’s owner’s booklet for specific blood glucose and AST
testing instructions.
IMPORTANT ‑ There is a delay (lag time) in the delivery of blood
glucose to non‑fingertip sites when compared to fingertip. Therefore,
there is a potential for a significant difference between fingertip and
AST results. The length of delay (lag time), is strongly impacted by
lifestyle, foods eaten, or any other event having impact on blood
glucose levels. It is important that people considering non‑fingertip
testing understand the following:
Talk to your doctor if you are considering testing on sites other
than your fingertip.
AST testing is not recommended during periods of rapid
decreases or increases in blood glucose levels.
AST testing is not recommended for people with a history of
recurrent hypoglycemia, who suspect their blood glucose is
extremely low, or who are unaware of hypoglycemic events.
Never
ignore symptoms of high or low blood sugar.
Do not change your treatment based on one result.
If the AST reading does not match how you feel, perform a
fingertip test to confirm your results. If your blood glucose still
does not reflect the way you feel, contact your doctor. For more
information on AST testing please contact ACCU‑CHEK Customer
Care service center at 1‑800‑858‑8072.
Do not test blood from the forearm, the upper arm, the calf and the
thigh:
up to two hours following a meal, when blood glucose values can
change quickly
after exercise
if you have a temperature or if a medical condition is limiting your
mobility, e.g. after breaking a leg or being confined to bed
during peak action time of short‑acting insulin (up to
approximately 4 hours after the injection) or rapid‑acting insulin
analogues (up to approximately 2 hours after the injection)
Remove the colored cap from the lancing device.
1.
Insert a new lancet into the lancing device as described in the 2.
section “Performing a Fingerstick” of this package insert.
Attach the clear plastic AST cap. As with the colored cap, the
3.
locating notch in the cap must be directly aligned with the
locating line on the lancing device. The AST cap must click into
place.
Adjust the clear AST cap to the highest setting.
4.
Wash the non‑fingertip site with warm water and dry it thoroughly. 5.
Prime the lancing device by pressing down the plunger all the
6.
way down until it stops.
Press and hold the lancing device against the fleshy area on the
7.
chosen AST site. Press the release button again and continue to
apply steady pressure to the site.
Perform a blood sugar test with your ACCU‑CHEK Compact Plus
8.
meter as instructed in the section “Running a Blood Sugar Test
with Blood from Your Fingertip” of your ACCU‑CHEK Compact Plus
system’s owner’s booklet.
Don’t be afraid to apply strong pressure to the area with the lancing
device to get a good blood drop.
Caring For Your Lancing Device
Your lancing device requires very little care.
Keep it away from extreme temperatures.
Clean the outside of your lancing device regularly and always if
any blood gets on it with 70 % isopropyl (rubbing) alcohol to keep
it in good working condition. In addition, thoroughly wipe the
inside of the cap using a cotton bud lightly moistened with the 70
% isopropyl (rubbing) alcohol. After cleaning, allow the lancing
device time to dry thoroughly. Never dip the lancing device or the
caps (colored cap and clear AST cap) in cleaning liquid. Doing so
may damage the internal parts of the lancing device so affecting
its operation.
Do not dip the lancing device in liquid.
Do not use bleach to clean the lancing device or caps.
Also Available from Roche Diagnostics
ACCU‑CHEK Compact Plus System
ACCU‑CHEK Softclix Lancets
100/box
200/box
ACCU‑CHEK Compact Test Strips
51/box
102/box
ACCU‑CHEK Compact Blue Control Solution
2 x 3 mL/box
Assistance Available
If you need assistance, please contact the ACCU‑CHEK Customer Care
Service Center toll‑free, 24 hours a day, 7 days a week. We offer
assistance in Spanish and many other languages.
1‑800‑858‑8072 phone
1‑800‑858‑8074 TDD/TYY (for hearing impaired)
One (1) Year Warranty
Roche warrants the ACCU‑CHEK Softclix Plus lancing device against
defects in materials and workmanship for a period of one (1) year from
the date of purchase. The liability of Roche under this warranty is
limited to the repair or replacement, at Roche’s option, of all parts or
materials proven to be defective. This warranty does not cover repair
or replacement of ACCU‑CHEK Softclix Plus lancing devices which have
been subjected to alteration, misuse, tampering, or abuse.
THE FOREGOING WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES,
WHETHER EXPRESS, IMPLIED, OR STATUTORY. ROCHE DISCLAIMS ANY
AND ALL IMPLIED WARRANTIES, INCLUDING THE IMPLIED WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
Roche’s entire liability with respect to the ACCU‑CHEK Softclix Plus
lancing device shall be the repair or replacement of nonconforming
devices, at Roche’s option. In no case shall Roche be liable for
incidental, indirect, special, or consequeontial damages, so the above
limitation and exclusion may not apply to you. This warranty gives you
specific legal rights, and you may have other rights which vary from
state to state. All inquiries about the ACCU‑CHEK Softclix Plus lancing
device under the above warranty or service policy must be directed to
ACCU‑CHEK Customer Care Service Center by calling 1‑800‑858‑8072.
You will be informed of the procedure necessary for replacement.
Please DO NOT return any device to Roche without authorization.
IMPORTANT – Read carefully before use. Caution: A restricted license
limits the use of this ACCU‑CHEK Softclix Plus lancing device in the
United States.
The ACCU‑CHEK Softclix Plus lancing device and its use are protected
by U.S. Patent Nos. Re.35,803; 6,419,661; 7,077,828; 7,322,998.
A license to use the ACCU‑CHEK Softclix Plus lancing device is only
granted when ACCU‑CHEK Softclix lancets are used with the
ACCU‑CHEK Softclix Plus lancing device.
ACCU‑CHEK Softclix lancets are high precision components that are
produced to the close tolerances required for satisfactory operation
with the ACCU‑CHEK Softclix Plus lancing device. Use of other lancets
with the ACCU‑CHEK Softclix Plus lancing device may prevent or impair
proper function of the ACCU‑CHEK Softclix Plus lancing device.
Using the ACCU‑CHEK Softclix Plus lancing device indicates your
acceptance of the restricted license to use the ACCU‑CHEK
Softclix Plus lancing device only with ACCU‑CHEK Softclix lancets.
Further, if you have purchased an ACCU‑CHEK Softclix Plus lancing
device that includes this restricted license, then this restricted license
applies regardless of any additional offers found in ACCU‑CHEK
Softclix Plus lancing device packages. If you do not agree to the terms
and conditions of the restricted license, you may return, at the place of
purchase, the unused ACCU‑CHEK Softclix Plus lancing device for a full
refund. If you have any questions, please call the ACCU‑CHEK
Customer Care Service Center at 1‑800‑858‑8072.
Except where prohibited by statute, all warranties covering the
ACCU‑CHEK Softclix Plus lancing device are voided by use of the
ACCU‑CHEK Softclix Plus lancing device with any lancets other than
ACCU‑CHEK Softclix lancets.
Visit our website at www.accu‑chek.com.
This product is covered by the following U.S. Patents: 6,419,661;
7,077,828; 7,322,998; 6,464,649 and Re. 35,803.
C
This product fulfils the requirements of Directive
93/42/EEC on medical devices.
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