Dear
Easy•Touch®
HealthPro™
Glucose Monitoring System Owner
Important Information
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Thank you for choosing the EasyTouch® HealthPro™ Glucose Monitoring
System. This manual contains everything you need to know about your new
glucose meter and how it works. Please take a moment to read the
instructions carefully.
The EasyTouch® HealthPro™ Glucose Monitoring System offers a fast, accurate,
and convenient way to read your glucose levels. The meter has been designed
to automatically turn on when the test strip is inserted into the meter,
automatically code the meter to the strip, and automatically turn off after
the reading. Please take a moment to read this manual to learn of more
convenient features to help you manage your diabetes. After doing so, we
hope you will agree, the EasyTouch® HealthPro™ Glucose Monitoring System
is designed to offer a better user experience.
Always consult with your healthcare professional before making any changes
to your diabetes management. The EasyTouch® HealthPro™ Glucose
Monitoring System is for in-vitro diagnostic use only. MHC Customer Service
is available toll free at (877) 358-4342, Monday thru Friday, 9am to 5pm EST.
Intended Use
The EasyTouch® HealthPro™ Glucose Monitoring System is intended to be
used for the quantitative measurement of glucose (sugar) in fresh capillary
blood samples drawn from the fingertips, ventral palm, dorsal hand,
upper arm, forearm, calf and/or thigh. The EasyTouch® HealthPro™ Glucose
Monitoring System is intended to be used by a single patient and should
not be shared.
The EasyTouch® HealthPro™ Glucose Monitoring System is intended for
self-testing by people with diabetes at home and on the go, and also for
healthcare professionals in a clinical setting. The EasyTouch® HealthPro™
Glucose Monitoring System should not be used for the diagnosis of or
screening of diabetes or for neonatal use. Alternative site testing should be
done only during steady–state times (when glucose is not changing rapidly).
The EasyTouch® HealthPro™ Glucose Test Strips are for use with the
EasyTouch® HealthPro™ Meter to quantitatively measure glucose (sugar) in
fresh capillary blood samples drawn from the fingertips, ventral palm, dorsal
hand, upper arm, forearm, calf and/or thigh.
The EasyTouch® HealthPro™ Glucose Control Solutions are for use with the
EasyTouch® HealthPro™ Meter and Test Strips to check that the meter and test
strips are working together properly. The test also serves as a quality control
to ensure the accuracy of the glucose test results.
The EasyTouch® HealthPro™ Glucose Monitoring System provides a quick and
easy way for patients with diabetes to measure their blood sugar levels.
It should only be used with fresh capillary blood samples. It is designed for
in-vitro diagnostics use only and should not be used for any purpose other
than monitoring blood sugar levels. It should not be used for the diagnosis of
diabetes or for the testing of newborns (neonates).
WARNING:
Do not change your medication based on the EasyTouch® HealthPro™
meter test results without contacting your physician or healthcare
professional.
Important Safety Instructions
The Centers for Disease Control and Prevention (CDC) and the US Food and
Drug Administration (FDA) have become increasingly concerned about
the risks for transmitting Hepatitis B virus (HBV) and other blood born
pathogens to persons undergoing finger stick procedures for blood sampling
(Ex. Persons with diabetes who require assistance monitoring their blood
glucose levels). Reports of HBV infection outbreaks linked to diabetes care
have been increasing. This notice serves as a reminder that finger stick
devices should never be used for more than one person.
WARNING:
1. The EasyTouch® HealthPro™ Meter and Lancing Device are for single
patient use only. Do not share them with anyone, including other family
members. Do not use on multiple patients.
2. All parts of the kit are considered bio-hazardous and can potentially
transmit infectious diseases, even after you have cleaned
and disinfected.
3. Always use a new sterile lancet. Lancets are for single use only.
4. Avoiding getting hand lotions, oil, dirt or debris in and/or on the lancets
and lancing device.
5. Please refer to page 33 for cleaning and disinfecting the EasyTouch®
HealthPro™ Glucose Monitoring System.
“FDA Public Health Notification: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting
Blood born Pathogens: Initial Communication Update 11/29/2010”
http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm224025.htm
“CDC Clinical Reminder: Use of Finger stick Devices on More than One Person Poses Risk for Transmitting Blood
born Pathogens”(2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
