Future Diagnostics CareTouch User manual

Blood Glucose and ß -Ketone Monitoring System
Owner’s Manual

English
Dear Care Touch System Owner:
Thank you for choosing the Care Touch Blood Glucose and ß-Ketone
Monitoring System. This manual provides important information to
help you to use the system properly. Before using this system, please
read the following contents thoroughly and carefully.
The System measures blood glucose, and ß-ketone. Regular
monitoring of your blood glucose and ß-ketone levels can help you and
your doctor gain better control of your diabetes. Due to its compact
size and easy operation, you can use the Care Touch Blood Glucose
and ß-Ketone Monitoring System to easily monitor your blood glucose
and ß-ketone levels by yourself anywhere, any time.
If you have other questions regarding this product, please contact
the local customer service or place of purchase.
Intended Use
Care Touch Blood Glucose and ß-Ketone Monitoring System is
intended for the quantitative measurement of glucose in fresh capillary
whole blood from the finger, and for the quantitative measurement of
ß- ketone (beta-hydroxybutyrate) in fresh capillary whole blood from
the finger. The Care Touch is intended for in vitro diagnostic use and is
intended for single-patient use as an aid to monitor the effectiveness of
a diabetes control program. The system should not be used for the
diagnosis of or screening for diabetes.
Version 1.0
2017-03

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
The meter and lancing device are for single patient use. Do not
share them with anyone including other family members! Do not
use on multiple patients!

All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed cleaning and disinfection.
For more information, please visit
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/ucm
224025.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
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by
the manufacturer.
3. Do NOT use the device if it is not working properly or if it
is damaged.

4. Do NOT use the equipment in places where aerosol sprays
are being used, or where oxygen is being administered.
5. Do NOT under any circumstances use the device on neonates
or infants.
6. This device does NOT serve as a cure for any symptoms
or diseases. The data measured is for reference only.
7. Before using this device, read all instructions thoroughly and practice
the test. Carry out all the quality control checks as directed.
8. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips,
lancets and vial caps are choking hazards.
9. Do not use this instrument in close proximity to sources of strong
electromagnetic radiation, as this may interfere with the accurate
operation.
10.Proper maintenance and periodically control solution test are
essential to the longevity of your device. If you are concerned
about your accuracy of measurement, please contact your local
customer service or place of purchase for help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN
1
Important Information
1
Test Principle
2
Contents of System
2
Meter Overview (awaits update)
3
Display Screen
4
Test Strip
4
SETTING THE METER
5
THE FOUR MEASURING MODES
6
BEFORE TESTING
7
Calibration
7
How to Code Your Meter (for ß-Ketone)(b)
7
Checking the Code Number
7
Control Solution Testing
8
Performing a Control Solution Test
8
TESTING WITH BLOOD SAMPLE
10
Preparing the Lancing Device for Blood Testing
10
Preparing the Puncture Site
10
Performing a Blood Glucose / ß-Ketone Test
12
METER MEMORY
13
Reviewing Test Results
14
Reviewing Blood Glucose Day Average Results
14
DOWNLADING RESULTS TO A COMPUTER
15
Data transmission via cable
15
MAINTENANCE
16
Battery
16
Caring for Your Meter
17
Disinfecting Procedures
18
Caring for Your Test Strips
20
Important Control Solution Information
20
SYSTEM TROUBLESHOOTING
21
Result Readings
21
Error Messages
22
Troubleshooting
23
Reference values
24
Comparing Meter and Laboratory Results
25

SYMBOL INFORMATION
26
SPECIFICATIONS
27

BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are
suffering from severe dehydration, consult a healthcare
professional immediately.

If your blood glucose results or ß-ketone are lower or higher than
usual, and you do not have any symptoms of illness, first repeat
the test. If you have symptoms or continue to get results which are
higher or lower than usual, follow the treatment advice of your
healthcare professional.

Use only fresh whole blood samples to test your blood glucose or
ß-ketone. Using other substances will lead to inaccurate results.

If you are experiencing symptoms that are inconsistent with your
blood glucose or ß-ketone test results and you have followed all
the instructions given in this owner’s manual, contact your
healthcare professional.

The device should not be used on severely hypotensive individuals
or patients in shock. Readings which are lower than actual values
may occur for individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis. Please consult the
healthcare professional before use.

Limitation
The device should not be used on individuals in hyperglycemic-
hyperosmolar state, with or without ketosis; not for neonatal use;
not for use on critically ill patients.
1

Test Principle
Your system measures the amount of sugar (glucose) or ß-ketone in
whole blood. The glucose or ß-ketone testing is based on the
measurement of electrical current generated by the reaction of glucose
or ß-ketone with the reagent of the strip. The meter measures the
current, calculates the blood glucose or ß-ketone level, and displays
the result. The strength of the current produced by the reaction
depends on the amount of glucose or ß-ketone in the blood sample.
Contents of System
Your new blood glucose and ß-ketone monitoring system kit includes:
1. Meter
2. Owner’s Manual
3. Protective Wallet
4. Quick Start User Guide
Test strips (d), control solutions (e), sterile lancets (g) or lancing device
(f) are not included in the kit. They must be purchased separately. Please
make sure you have those items needed for a test beforehand.
NOTE:
If any items are missing from your kit or opened prior to use, please
contact local customer services or place of purchase for assistance.
2

Meter Overview (awaits update)
1. Test Strip Slot & Strip Indicator
Insert test strip here to turn the meter on for
testing.Connect strip port cable for data transmission.
2. Test Strip Ejector
Eject the used strip by pushing up this button.
3. Display Screen
4. M Button (M)
Enter the meter memory and silence a reminder alarm.
5. Battery Compartment
6. SET Button (S)
Enter and confirm the meter settings.
3