1 2 3 4 5
Alternate Site Testing (AST)
cap for obtaining blood from
a non-fingertip testing site
AST Cap
Instructions for Use
Intended Use
The lancing device is intended for the hygienic
collection of capillary blood for testing purposes from
the side of a fingertip and from other sites, such as the
palm, the upper arm, and the forearm, which is
referred to as non-fingertip testing or alternate site
testing. The lancing device is for use only on a single
patient.
For use only on a single patient. Disinfect
reusable components according to
manufacturer’s instructions between each use.
Each lancet may only be used once to obtain
blood. Used lancets must be safely discarded
after a single use.
WARNING
Do not use on more than one patient. Improper
use of blood lancets can increase the risk of
inadvertent transmission of bloodborne
pathogens, particularly in settings where
multiple patients are tested. The cleaning and
disinfection instructions for this device are
intended only to reduce the risk of local use site
infection; they cannot render this device safe
for use for more than one patient.
WARNING
z
z
Read these instructions and the instructions for
use of the Accu-Chek Softclix lancing device on
the other side of this package insert before
using blood from non-fingertip testing sites for
testing blood glucose.
z
z
Before you decide to use blood from non-
fingertip testing sites, consult your healthcare
professional.
z
z
Check the instructions for use for your blood
glucose meter or contact customer support to
determine whether you are allowed to test blood
from non-fingertip testing sites with your meter
and which testing sites are suitable.
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z
Blood obtained from the forearm or the upper
arm is not always suitable for blood glucose
testing (see section “Testing at the Right Time”).
Under certain conditions, the test results for
blood obtained from the forearm or the upper
arm can differ from test results for blood
obtained from the fingertip or the palm. These
differences can cause the wrong therapy
recommendation to be made and thus produce
serious adverse health effects.
z
z
If the test result for blood obtained from the
forearm or the upper arm does not match how
you feel, you should perform a test with blood
obtained from the fingertip or the palm. If this
test result also does not match how you feel,
contact your healthcare professional.
z
z
Use the AST cap only to obtain blood from non-
fingertip testing sites. If you use the AST cap to
obtain blood from the fingertip, the lancet
penetrates too deeply and may cause discomfort.
z
z
Keep the lancing device and all its components
away from children under the age of 3 years.
There is a risk of suffocation if small parts (e.g.
caps or similar objects) are swallowed.
z
z
Use the Accu-Chek Softclix AST cap only together
with the Accu-Chek Softclix lancing device.
Testing at the Right Time
Do not test blood obtained from the forearm or the
upper arm
z
z
up to two hours following a meal, when blood
glucose values can rise quickly
z
z
after injection of bolus insulin, when blood glucose
values can decrease quickly
z
z
after exercise
z
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if you are ill
z
z
if you think that your blood glucose is very low
(hypoglycemia)
z
z
if you know that you sometimes do not notice when
you are hypoglycemic
Do not use alternate site testing to calibrate a
continuous glucose monitoring system or to make
insulin dosing calculations.
Placing the AST Cap on the Lancing
Device
X
X
Remove the colored cap from the lancing device
(see
1
).
X
X
Insert a new lancet (see
2
).
X
X
Twist the protective cap off of the lancet (see
3
).
X
X
Place the AST cap on the lancing device, lining up
the notch on the cap with the notch on the lancing
device (see
4
). The cap must audibly click into
place.
Setting the Penetration Depth
X
X
Rotate the comfort dial on the cap until the desired
penetration depth is set (see
5
).
NOTE
To obtain a sufficiently large blood drop, the puncture
at non-fingertip testing sites must be deeper than at
the fingertip. However, these sites are usually less
sensitive to pain.
Obtaining a Blood Drop
WARNING
Only use the lancing device when the AST cap is
attached. Without the cap, the lancet penetrates
too deeply and may cause discomfort.
X
X
Choose a fleshy area of the non-fingertip testing
site. Wash it with warm water and soap and dry it
well.
X
X
Disinfect the selected puncture site. The puncture
site must dry completely afterwards.
X
X
Press the priming button all the way down to prime
the device (see
6
).
X
X
Press the lancing device firmly against the selected
puncture site.
X
X
Press the release button (see
7
).
The lancet is released and it penetrates the skin.
X
X
Press the lancing device firmly against the puncture
site for a few seconds.
You can watch the blood drop form through the AST
cap. The blood drop should be approximately this
size:
•
If the blood drop is smaller, release the pressure on the
puncture site for a few seconds without removing the
AST cap from the puncture site. Then reapply pressure
to the AST cap until the blood drop is big enough.
X
X
Test your blood glucose immediately after you obtain
blood, according to the instructions for use for your
blood glucose meter.
Ejecting the Used Lancet
X
X
Remove the cap from the lancing device (see
1
).
X
X
Slide the ejector forward (see
8
).
The used lancet is ejected.
X
X
Replace one of the two caps on the lancing device.
X
X
Dispose of used lancets according to local
regulations.
WARNING
Dispose of used lancets in such a way as to prevent
injury from the needles.
Cleaning and Disinfecting the Lancing
Device and AST Cap
Follow the instructions in the section “Cleaning and
Disinfecting the Lancing Device and Cap” on the other
side of this package insert in order to clean and
disinfect the lancing device and AST cap appropriately.
One (1) Year Warranty
Roche warrants the Accu-Chek Softclix 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
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 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 consequential damages. This
warranty gives you specific legal rights, and you may
have other rights which vary from state to state so the
above limitation and exclusion may not apply to you.
All inquiries about the Accu-Chek Softclix lancing
device under the above warranty or service policy
must be directed to the 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 use of the Accu-Chek Softclix
lancing device in the United States. The Accu-Chek
Softclix system (device and lancets) and its use are
protected by U.S. Patent Nos. 6,419,661 (expires
3-March-2020); 7,077,828 (expires 3-March-2020);
and 7,322,998 (expires 3-March-2020). A license to
use the Accu-Chek Softclix system is required until the
last-to-expire patent listed above and is only granted
when Accu-Chek Softclix lancets are used with the
Accu-Chek Softclix 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
lancing device. Use of other lancets with the Accu-Chek
Softclix lancing device may prevent or impair proper
function of the Accu-Chek Softclix lancing device.
Using the Accu-Chek Softclix lancing device indicates
your acceptance of the restricted license to use the
Accu-Chek Softclix lancing device only with Accu-Chek
Softclix lancets. Further, if you have purchased an
Accu-Chek Softclix lancing device that includes this
restricted license, then this restricted license applies
regardless of any additional offers found in Accu-Chek
Softclix 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 lancing device for a full refund. If
you have any questions, please contact the Accu-Chek
Customer Care Service Center at 1-800-858-8072.
Except where prohibited by statute, all warranties
covering the Accu-Chek Softclix lancing device are
voided by use of the Accu-Chek Softclix lancing device
with any lancets other than Accu-Chek Softclix lancets.
Patent Information
U.S. Pat.: http://www.roche-diagnostics.us/patents
References
1
FDA Public Health Notification: “Use of Fingerstick
Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial
Communication, (2010). Update 11/29/2010.”
http://www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/ucm224025.htm. Accessed June 1,
2016.
2
CDC Clinical Reminder: “Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens, (2010).” http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html.
Accessed June 1, 2016.
3
Healthcare Infection Control Practices Advisory
Committee (HICPAC), William A. Rutala, Ph.D., M.P.H.,
and David J. Weber, M.D., M.P.H. Centers for Disease
Control and Prevention, 2008. “Guideline for
Disinfection and Sterilization in Healthcare Facilities.”
Atlanta. http://www.cdc.gov/hicpac/pdf/guidelines/
Disinfection_Nov_2008.pdf. Accessed June 1, 2016.
DE 07575050001(03) – US 07575050003
ACCU-CHEK and SOFTCLIX are trademarks of Roche.
© 2017 Roche Diabetes Care
Global Trade Item Number
M
Roche Diabetes Care GmbH
Sandhofer Strasse 116
68305 Mannheim, Germany
www.accu-chek.com
Manufactured in Germany for:
Roche Diabetes Care, Inc.
Indianapolis, IN 46256, USA
Non-fingertip testing sites
Not all sites are compatible with all meters.
Consult your meter instructions for the non-
fingertip testing sites suitable for your meter.
1
Ball of the thumb
Preferred sites
2
Ball of the little finger
3
Inside of the forearm
4
Upper arm
5
Outside of the forearm
