Freestyle LIBRE PRO Operator's Manual page 43

Front
2nd fold
2.2"
• The Sensor Pack is sterile and non-pyrogenic unless opened or damaged.
Using a non-sterile or pyrogenic Sensor might cause infection.
• Store the Sensor Kit between 39 °F and 77 °F. While you don't need to
keep your Sensor Kit in a refrigerator, you can as long as the refrigerator is
between 39 °F and 77 °F.
• The Sensor has been tested to withstand immersion into 3 feet
(1 meter) of water for up to 30 minutes.
• Do not freeze. Do not use if expiration date has passed.
• Interfering Substances: Taking ascorbic acid (vitamin C) while wearing
For Health Care Professionals
the Sensor may falsely raise Sensor glucose readings. Taking salicylic acid
(used in some pain relievers such as aspirin and some skin care products)
may slightly lower Sensor glucose readings. The level of inaccuracy
READ THE READER KIT OPERATOR'S
depends on the amount of the interfering substance active in the body.
MANUAL BEFORE HANDLING THE
Test results did not indicate interference for methyldopa (used in some
SENSOR KIT PARTS.
drugs to treat high blood pressure) or tolbutamide (infrequently used
in some drugs to treat diabetes in the US) at maximum circulating
:
CAUTION
Federal law restricts this device to sale by
levels. However, concentrations of potential interferents in interstitial
or on the order of a physician.
fluid are unknown compared to circulating blood. Taking medications
Indications for Use with acetaminophen (such as Tylenol and some cold medicines) while
wearing the Sensor may falsely raise Sensor glucose readings. The level of
The FreeStyle Libre Pro Flash Glucose Monitoring System is a
inaccuracy depends on the amount of acetaminophen active in the body
professional continuous glucose monitoring (CGM) device indicated
and may be different for each person.
for detecting trends and tracking patterns in persons (age 18 and
• The alcohol wipe is labeled as follows: Saturated with 70% Isopropyl
older) with diabetes. The system is intended for use by health care
alcohol; For External Use only; Single use; Do not use if package is
professionals and requires a prescription.
opened or damaged; Sterilized using irradiation; Not made with natural
Readings from the FreeStyle Libre Pro Sensor are only made available
rubber latex. Covidien llc, 15 Hampshire St., Mansfield, MA 02048
to patients through consultation with a health care professional. The
www.covidien.com
System does not require user calibration with blood glucose values.
The FreeStyle Libre Pro System aids in the detection of glucose level
excursions above or below the desired range, facilitating therapy
adjustments. Interpretation of the FreeStyle Libre Pro Flash Glucose
Monitoring System readings should be based on the trends and
patterns analyzed through time using the reports available.
:
CONTRAINDICATION The FreeStyle Libre Pro System must
be removed prior to Magnetic Resonance Imaging (MRI),
Computed Tomography (CT) scan, or high-frequency electrical
heat (diathermy) treatment. The effect of MRI, CT scans, or
diathermy on the performance of the system has not been
evaluated. The exposure may damage the Sensor and may
impact proper function of the device to detect trends and track
patterns in the user's glucose values during the wear period.
WARNING:
The FreeStyle Libre Pro Flash Glucose Monitoring System contains
small parts that may be dangerous if swallowed.
CAUTION:
• Intense exercise may cause the Sensor to loosen due to sweat or
movement of the Sensor. If the Sensor becomes loose, the Sensor
readings may be unavailable or unreliable. Your patient should
return to your facility for application of a new Sensor.
• Severe dehydration and excessive water loss may cause inaccurate
results.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed
for single use. Reuse may result in no glucose readings and infection.
Not suitable for re-sterilization. Further exposure to irradiation may
cause inaccurate results.
• The Sensor Pack and Sensor Applicator are packaged as a set and
have the same Sensor code. Check that the Sensor codes match
before using the Sensor Pack and Sensor Applicator. Sensor Packs
and Sensor Applicators with the same Sensor code should be used
together or Sensor glucose readings may be incorrect.
• Some individuals may be sensitive to the adhesive that keeps the
Sensor attached to the skin. If your patient notices significant skin
irritation around or under their Sensor, they should remove the
Sensor and stop using the FreeStyle Libre Pro System. Follow your
facility's procedures for handling skin reactions.
User Safety, Storage, and Handling
Final Facing Fold
ART26946-001_rev-B.indd 1
3rd fold
2.25" 2.25"
Assembly | Application instructions:
STEP 1:
Select site.
STEP 2:
Clean site with alcohol wipe and allow site to
dry.
STEP 3: Peel lid completely off Sensor Pack. Unscrew
cap from Sensor Applicator.
CAUTION: Sensor codes must match on
Sensor Pack and Sensor Applicator. Do
NOT use if damaged or already opened.
STEP 4:
Line up dark marks on Sensor Applicator and
Sensor Pack. Press down firmly on Sensor
Applicator until it comes to a stop.
STEP 5: Lift Sensor Applicator out of Sensor Pack.
STEP 6: Sensor Applicator is ready to apply Sensor.
CAUTION: Sensor Applicator now
contains a needle. Do not touch inside
Sensor Applicator or put it back into
Sensor Pack.
STEP 7:
Place Sensor Applicator over site. Push down
firmly to apply Sensor.
CAUTION: Do NOT push down on Sensor
Applicator until placed over prepared site
to prevent unintended results or injury.
STEP 8: Gently pull Sensor Applicator away.
STEP 9: Make sure Sensor is secure. Discard used
Sensor Applicator and Sensor Pack according
to your facility's procedures.
Refer to your Operator's Manual for full system instructions
and information.
Distributed by:
Abbott Diabetes Care Inc.
1360 South Loop Road
Alameda, CA 94502 USA
Customer Service: 1-855-632-5297
Monday through Friday,
8AM to 8PM Eastern Standard Time
1st fold (to half)
2.25"
1
2
3
4
IMPORTANT:
• You should not wear a Sensor for more than 14 days.
• Contact your health care professional if:
– Your Sensor becomes loose or is removed.
– You have irritation or discomfort at the Sensor site.
– You have any questions about your Sensor.
5
Your Sensor is water-resistant and can be worn while bathing, showering,
or swimming.
Note: Do NOT take your Sensor deeper than 3 feet (1 meter) or immerse it
longer than 30 minutes in water.
Removing Your Sensor
Follow these instructions if you need to remove your Sensor.
6
7
8
WARNING: The FreeStyle Libre Pro Sensor contains small parts that may
be dangerous if swallowed.
CAUTION: Some individuals may be sensitive to the adhesive that keeps
the Sensor attached to the skin. If you notice significant skin irritation
9
around or under your Sensor, remove the Sensor and stop using the
FreeStyle Libre Pro Sensor. Contact your health care professional for
handling skin reactions.
2.25" 2.2"
INTERFERING SUBSTANCES: Taking ascorbic acid (vitamin C)
while wearing the Sensor may falsely raise your Sensor glucose
readings. Taking salicylic acid (used in some pain relievers such as
aspirin and some skin care products) may slightly lower your Sensor
glucose readings. The level of inaccuracy depends on the amount
of the interfering substance active in the body. Test results did not
indicate interference for methyldopa (used in some drugs to treat
high blood pressure) or tolbutamide (infrequently used in some
drugs to treat diabetes in the US) at maximum circulating levels.
However, concentrations of potential interferents in interstitial fluid
Living With Your FreeStyle
are unknown compared to circulating blood. Taking medications with
Libre Pro Sensor
acetaminophen (such as Tylenol and some cold medicines) while
wearing the Sensor may falsely raise your Sensor glucose readings.
The level of inaccuracy depends on the amount of acetaminophen
The FreeStyle Libre Pro Sensor measures and
active in your body and may be different for each person.
stores your glucose data while worn on your body
for up to 14 days. Your health care professional
can download your data at anytime from a Sensor
that's on or off your body.
Pull up the edge of the adhesive that keeps your
Sensor attached to your skin. Slowly peel away
from your skin in one motion.
Note: Any remaining adhesive residue on the
skin can be removed with warm soapy water or
isopropyl alcohol.
CONTRAINDICATION: The FreeStyle Libre Pro Sensor
must be removed prior to Magnetic Resonance Imaging
(MRI), Computed Tomography (CT) scan, or high-frequency
electrical heat (diathermy) treatment. The effect of MRI, CT
scans, or diathermy on the performance of the system has
not been evaluated. The exposure may damage the Sensor
and may impact proper function of the device to detect
trends and track patterns in the user's glucose values during
the wear period.
9/23/16 9:16 AM