6
7
CAUTION: Do not take any decision of medical relevance without first
consulting your healthcare practitioner.
If the device is being used for the monitoring of an existing disease, only
adapt the treatment if you have received the appropriate training to do so.
The CardioChek analyzer is fast, portable, and reliable. This analyzer is a component of
a test system that includes PTS Panels self-test strips. The PTS Panels self-test strip box
includes a MEMo Chip
that contains the assay calibration curve and other important
information about the assay. The PTS Panels self-test strip box also includes PTS Collect
capillary tubes (
15 µL) and auto-disabling, single-use lancets. PTS Panels self-test
strips are sold separately and are available as single-analyte self-test strips.
This test system uses reflectance photometry technology. An enzymatic reaction on the
test strip produces a color change that is detected by the analyzer after whole blood
is applied.
Please remember to return the enclosed warranty card to PTS Diagnostics to ensure that
you receive product updates and other important information.
For questions or additional assistance with your CardioChek test system, please contact
PTS Diagnostics (Hours: 6:00 a.m. to 9:00 p.m. US EST) using the following contact
information:
PTS Diagnostics
7736 Zionsville Road, Indianapolis, IN 46268 USA
Direct:
+1-317-870-5610
·
Toll-free inside the US:
1-877-870-5610
Fax:
+1-317-870-5608
Email:
·
Website:
ptsdiagnostics.com
Important Safety Instructions
This is a medical device and needs to be treated with care. In particular there is the risk
of disease transmission when using blood glucose monitoring systems and they should
be used with caution and care.
1,2
The analyzer and lancing device are for single patient use. For safety reasons, do not
share them with anyone including other family members. Do not use on multiple
patients.
All parts of your device come into contact with your blood and are biohazardous.
Kit parts can potentially transmit infectious diseases, even after being cleaned and
disinfected.
Always wash your hands thoroughly with soap and water and dry well after handling
the analyzer, test strips, or your lancing device.
Always consult your diabetes healthcare professional and follow his or her guidance
about your blood glucose monitoring routine.
Blood samples and blood products are potential sources of hepatitis and
other infectious diseases. Handle all parts of your device with care. Do not
share your analyzer. It is for single-patient use only. Any items that are used
to conduct a test such as test strips, lancets, and alcohol swabs, must be
disposed of safely to avoid the risk of infection. Please follow your healthcare
provider’s instructions for proper disposal.
References:
1.
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
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.
