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

Display Screen
1. Glucose Symbol
2. Ketone Symbol/
Ketone Warning
3. Test Result
4. Warning Symbol
5. Low Battery Symbol
6. Day Average
7. Memory Symbol
8. Date/Time
9. Measurement Unit
10.Measurement Modes
AC –before meal PC
–after meal Gen –
any time of day
QC –control solution test
11.Test Strip Symbol
12.Blood Drop Symbol
13.Code
Test Strip
1. Absorbent hole
2. Confirmation window
3. Test strip handle
4. Contact bars
Attention:
The front side of the test strip should face up when
inserting the test strip. Test results might be wrong if
the contact bar is not fully inserted into the test slot.
4

NOTE:
The Care Touch Blood Glucose and ß-ketone Monitoring System
should only be used with Care Touch Test Strips. Using other test
strips with this monitoring system may produce inaccurate results
SETTING THE METER
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings.
Entering the Setting Mode (a)
Start with the meter off (no test strip inserted). Press SET (S).
1. Setting the date
The sequence of the date setting is: YEAR →MONTH →DAY. With
the YEAR/MONTH/DAY flashing in sequence, press M button
(M) until the correct year/month/day appears. Press S.
2. Setting the time format
Press Mto select the desired time format (12h or 24h). Press S.
3. Setting the time
With the Hour/Minute flashing in sequence, press Muntil the
correct hour/minute appears. Press S.
4. Setting the measuring unit
With the measuring unit flashing, press Mto switch between mg/dL
or mmol/L. Press S.
5. Setting the buzzer
With the flashing, press Mto switch between “On” and “Off”.
Press S.
6. Deleting the memory
With “dEL” and a “ ” symbol on the display, press Mand select
5

“no” to keep the results in memory then press Sto skip. To delete all the
results, press Mand select “yes” to delete all memory records.
7. Setting the reminder alarm
The meter has four reminder alarms. The meter will display “OFF”
and “AL1 ”. If you don’t want to set an alarm, press Sto skip this
step; or press Mto select “On”, then press S. With the
hour/minute flashing in sequence, press M to select the correct
hour/minute. Press Sand go to the next alarm setting.
NOTICE:
When the alarm beeps, press Mto switch it off. Otherwise, it
will beep for 2 minutes then switch off.
8. Setting the backlight
The default setting for meter backlight ("BL") is set to ON.
Press M to switch between “On” and “OFF”. Press S.
Congratulations! You have completed all settings!
NOTE:
These parameters can ONLY be changed in the setting mode.
If the meter is idle for 3 minutes during the setting mode, it
will switch off automatically.
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring: General,
AC, PC and QC. You can switch between each mode by:
1. Start with the meter switched off. Insert a test strip to turn on the
meter. The screen will display a flashing blood drop and “Gen”.
2. Press Mbutton to switch between General, AC, and PC modes.
6

BEFORE TESTING
Calibration
You must calibrate the meter every time you begin to use a new vial
of ß-Ketone test strips by setting the meter with the correct code. Test
results may be inaccurate if the code number displayed on the
monitor does not match the number printed on the strip vial.
How to Code Your Meter (for ß-Ketone)(b)
1. Insert the code strip when the monitor is off. Wait until the
code number appears on the display.
NOTICE:
Make sure the code number on display, code strip, and test strip vial
are the same. The code strip should be within the expiry date;
otherwise, an error message may appear.
2. Remove the code strip, the display will show “OK”. This tells you
that the meter has finished coding and is ready for ß-ketone testing.
Checking the Code Number
You need to make sure that the code number displayed on the meter
matches the number on your test strip vial before you proceed. If it
matches, you can proceed with your test. If the codes do not match,
please stop testing and repeat the calibration procedure. If the
problem persists, contact Customer Service for help.
NOTICE:
The codes used in this manual are examples only; your meter
may display a different code.
7

WARNING:
It is important to make sure that the LCD displayed code is the
same as the code on your test strip vial before testing. Failure to do
so will get inaccurate results.

The code number for ß-Ketone strip is three-digits; please
ensure you are using the correct strips for the test.

If the LCD displayed code is not the same as the code on your
test strip vial and the code number cannot be updated, please
contact Customer Service for assistance.
Control Solution Testing
Our Control Solution contains a known amount of glucose that
reacts with test strips and is used to ensure your meter and test
strips are working together correctly.
Do a control solution test when:
You first receive the meter
At least once a week to routinely check the meter and test strips
You begin using a new vial of test strips
You suspect the meter or test strips are not working properly

Your blood glucose or ketone test results are not consistent
with how you feel, or if you think the results are not accurate
Practicing the testing process, or
You have dropped or think you may have damaged the meter
Performing a Control Solution Test
To perform a control solution test, you will need: (c), (d) and (e).
1. Insert the test strip into the meter. There will be a strip light
indicating the test strip is inserted into the test slot. Wait for the
meter to display “ ” and “ ”.
8

2. Press M to mark this test as a control solution test
With “QC” displayed, the meter will store your test result in
memory under “QC”. If you press Magain, the “QC” will disappear
and this test is no longer a control solution test.
3. Apply Control Solution (h)
Shake the control solution vial thoroughly before use. Squeeze out
a drop and wipe it off, then squeeze out another drop and place it
on the tip of the vial cap. Hold the meter to move the absorbent
hole of the test strip to touch the drop. Once the confirmation
window fills completely, the meter will begin counting down. To
avoid contaminating the control solution, do not directly apply
control solution onto a strip.
4. Read and Compare the Result
After counting down to 0, the control solution test result will appear
on the display. Compare this result with the range printed on the
test strip vial and it should fall within this range. If not, please read
the instructions again and repeat the control solution test.
With “QC” displayed, the meter will store your test result in
memory under “QC”.
Out-of-range results
If you continue to have test results fall outside the range printed on the test
strip vial, the meter and strips may not be working properly. Do NOT test
your blood. Call customer service at 1.866.890.8500 for help.
NOTE:
The control solution range printed on the test strip vial is for
control solution use only. It is not a recommended range for your
blood glucose or ketone level.

See MAINTENANCE section for important information about
your control solutions.
9

TESTING WITH BLOOD SAMPLE
WARNING:
To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet. Lancets are for single use only.

Avoid getting hand lotion, oils, dirt, or debris in or on the
lancets and the lancing device.

Wash and dry your hands thoroughly after handling the
meter, lancing device and test strips to prevent infection. For
more information, please refer to the “Cleaning and
Disinfection” section.

If the meter is being operated by a second person who is providing
testing assistance to the user, the meter and lancing device should be
decontaminated prior to use by the second person.
Sharing the lancing device and lancets may increase the risk of
contracting infectious diseases. Lancing device must not be
used for more than one person.
Preparing the Lancing Device for Blood Testing
Please refer to the manufacturer’s instructions for the lancing device
to collect a blood sample.
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood
extraction significantly reduces variations between measurements.
Please follow the suggestions below before obtaining a drop of blood:
Wash and dry your hands before starting.
Select the puncture site at fingertips
10

Rub the puncture site for about 20 seconds before penetration.

Clean the puncture site using cotton moistened with 70%
alcohol and let it air dry.
Fingertip testing (i)
Press the lancing device’s tip firmly against the lower side of your
fingertip. Press the release button to prick your finger, then a
click indicates that the puncture is complete.
NOTE:
Choose a different spot each time you test. Repeated punctures
at the same spot may cause soreness and calluses.

It is recommended that you discard the first drop of blood as it
might contain tissue fluid, which may affect the test result.
11

Performing a Blood Glucose / ß-Ketone Test
To perform a blood glucose or ß-ketone test, you will need: meter
(c), strip (d), sterile lancet (g) and lancing device (f).
1. Insert the test strip to turn on the meter
Wait for the meter to display “ ”, “ ” and “GLU”, or
“KETONE”.
2. Select the appropriate measuring mode by pressing M.
3. Obtaining a blood sample (j)
Use the pre-set lancing device to puncture the desired site(i). Wipe
off the first appeared drop of blood with a clean cotton swab. Gently
squeeze the punctured area to obtain another drop of blood. The
volume of blood sample must be at least 0.9 microliter ( ìL) for
blood glucose test, 1.0 microliter (ìL) for blood ß-Ketone test.Be
careful NOT to smear the blood sample.
4. Apply the Sample (k)
Gently apply the drop of blood to the absorbent hole of the test strip
at a tilted angle. Confirmation window should be completely filled if
enough blood sample has been applied. Do NOT remove your
finger until you hear a beep sound.
NOTE:
Do not press the punctured site against the test strip or try
to smear the blood.

If you do not apply a blood sample to the test strip within 3
minutes, the meter will automatically turn off. You must
remove and reinsert the test strip to start a new test.

The confirmation window should be filled with blood before the
meter begins to count down. NEVER try to add more blood to
the test strip after the drop of blood has moved away. Discard
the used test strip and retest with a new one.
12

If you have trouble filling the confirmation window, please
contact your health care professional or the local customer
service for assistance.

5. Read Your Result
The result of the blood glucose test / ß-ketone will appear after the
meter counts down to 0. The blood glucose / ß-ketone test result
will automatically be stored in the memory.
6. Remove the used test strip and lancet (m)
Eject the test strip by pushing the eject button on the side. Use a
sharp bin to dispose of used test strips. The meter will switch
itself off automatically.
Always follow the instructions in the lancing device package
insert when removing the lancet.
WARNING:
․The used lancet and test strip may be biohazards. Please follow
your healthcare provider’s recommendations for proper disposal.
․Wash your hands thoroughly with soap and water after handling
the meter, lancing device and test strips to avoid contamination.
For more information, please refer to the “Cleaning and
Disinfection” section.
METER MEMORY
The meter stores the 1000 most recent blood glucose or ß-ketone
test results along with respective dates and times in its memory. To
enter the meter memory, start with the meter switched off.
13