LiteTouch CareSens N Voice User manual

Alternate Care User's Manual
Blood Glucose
Monitoring System

1
Table of Contents
Information
Important Information: Read This First..................................................................................................2
Important Health-Related Information..................................................................................................3
Specifications..................................................................................................................................................3
LiteTouch CareSens N Voice Multi Blood Glucose Monitoring System .......................................4
Inserting or Replacing the Batteries ......................................................................................................4
LiteTouch CareSens N Multi Test Strip....................................................................................................4
LiteTouch CareSens N Voice Multi Blood Glucose Meter.................................................................5
CareSens N Voice Multi Blood Glucose Meter Display.....................................................................5
Preparation
Setting Up Your System...............................................................................................................................6
Adjusting Language, Date, Time, and Sound...................................................................................6
Setting the Hypoglycemia Indicator....................................................................................................7
Checking the System....................................................................................................................................7
Control Solution Testing..........................................................................................................................8
Comparing the Control Solution Test Results..................................................................................8
Blood Glucose Testing
Blood Glucose Testing..................................................................................................................................9
Preparing the Meter and Test Strip......................................................................................................9
Flagging Post-Meal Test Results ...........................................................................................................9
Applying the Blood Sample...................................................................................................................9
Alternative Site Testing..............................................................................................................................10
Hi and Lo Messages.....................................................................................................................................11
Transferring Test Results.............................................................................................................................11
Additional Functions
Meter Memory...............................................................................................................................................11
Viewing Past Test Averages...................................................................................................................12
Viewing Test Results................................................................................................................................12
Setting the Alarm Function......................................................................................................................12
Setting the Post-Meal Alarm (PP2 Alarm).........................................................................................12
Setting the Time Alarms (Alarm 1 - 3)................................................................................................13
Maintenance
Caring for Your System...............................................................................................................................13
Cleaning and Disinfection.....................................................................................................................13
Cleaning and Disinfection Procedures..............................................................................................14
Caution: Storage and Handling...........................................................................................................15
Understanding Error and Other Messages..........................................................................................15
General Troubleshooting..........................................................................................................................16
Performance Characteristics....................................................................................................................16
Warranty Information.................................................................................................................................17
LiteTouch CareSens N Voice Multi Blood
Glucose Monitoring System
Thank you for choosing the LiteTouch CareSens® N Voice Multi Blood Glucose
Monitoring System. The system provides you with safe, fast, and convenient
blood glucose in vitro (i.e., outside the body) monitoring. The bilingual talking
function of LiteTouch CareSens® N Voice Multi Meter can be used as an aid for
using the meter. The meter is not intended to be used by visually impaired
persons. The LiteTouch CareSens® N Voice Multi Meter is also designed to
minimize code related errors in monitoring by using the auto coding function.
You’ll receive an accurate result in five seconds with a small 0.5 μL blood
sample. This Alternate Care Manual contains important information about the
LiteTouch CareSens® N Voice Multi Blood Glucose Monitoring System. Please
read it carefully before testing your blood glucose.
© 2014 MediCore. All Rights Reserved. PGA1E3219 REV0 02/2014
Contact Customer Service:
1-800-429-5001
9 am - 9 pm EST, Monday - Saturday. In case of emergency, contact your
healthcare professional or emergency medical response team.
Manufactured for:
MediCore
2832 Logan Street, Suite B
Nashville, TN 37211
www.MediCore.com
APPROVAL
E C REP

Important Information:
Read This First
To receive safe and optimum system benefits,
please read the entire manual contents before
using the system. Please note the following
instructions:
• Do not use the system for diagnosis or screening
of diabetes.
• Use only fresh capillary whole blood samples for
testing.
• Alternative site and fingertip test results may
differ significantly due to rapid changes in the
blood glucose level after eating, insulin injection,
or exercise.
Important Safety Instructions:
• All parts of the LiteTouch CareSens N Voice Multi
Blood Glucose Monitoring System should be
considered potentially infectious and are capable
of transmitting blood-borne pathogens between
patients and healthcare professionals. For more
information, refer to "Guideline for Isolation
Precautions: Preventing Transmission of Infectious
Agents in Healthcare Settings 2007", http://www.
cdc.gov/hicpac/2007ip/ 2007isolationprecautions.
html.
• Only auto-disabling, single use safety lancets
should be used with this system.
• The meter should be cleaned and disinfected
after use on each patient. This BGMS may only be
used for testing multiple patients when standard
precautions and the manufacturer's disinfection
procedures are followed.
Intended Use
The LiteTouch CareSens N Voice Multi Blood Glucose
Monitoring System is intended for the quantitative
measurement of glucose in fresh capillary whole
blood samples drawn from the fingertips and
alternative sites such as the forearm, palm, thigh,
and calf. Alternative site testing should be used only
during steady-state blood glucose conditions. The
LiteTouch CareSens N Voice Multi Blood Glucose
Monitoring System is intended for use (outside the
body) in vitro and is intended for multiple-patient
use in professional healthcare settings as an aid to
monitor the effectiveness of diabetes control. The
system is only used with auto-disabling, single use
safety lancets. It is not intended for use on neonates
and is not for the diagnosis or screening of diabetes.
The voice feature is not intended for use by visually
impaired persons.
The LiteTouch CareSens N Multi Blood Glucose Test
Strips are for use with the LiteTouch CareSens N Voice
Multi Blood Glucose Meter to quantitatively measure
glucose in fresh capillary whole blood samples
drawn from the fingertips and alternative sites.
The CareSens Control Solutions are for use with the
LiteTouch CareSens N Voice Multi Blood Glucose
Meter and LiteTouch CareSens N Multi Test Strips to
check that the meter and the test strips are working
together properly and that the test is performing
correctly.
• The LiteTouch CareSens N Voice Multi Blood
Glucose Monitoring System is intended for in vitro
(outside the body) diagnostic use only and for the
quantitative measurement of glucose in capillary
whole blood.
• The LiteTouch CareSens N Voice Multi Blood Glucose
Monitoring System is intended for use by Healthcare
Professionals for monitoring blood glucose levels in
a multi-patient, multi-user setting. After each use,
healthcare personnel should change gloves.
• The LiteTouch CareSens N Voice Multi Blood Glucose
Meter is designed to minimize code related errors
while monitoring by using the no-coding function.
• The glucose in the blood sample mixes with special
chemicals on the test strip to produce a small
electrical current. The LiteTouch CareSens N Voice
Multi
Blood Glucose Meter converts this electrical
current to glucose concentration.
• The LiteTouch CareSens N Voice Multi Blood Glucose
Meter should be used only with the LiteTouch
CareSens N Multi Test Strips.
• An abnormally high or low red blood cell count
(hematocrit level over 60% or below 20%) may
produce inaccurate results.
• Inaccurate results may occur in severely hypotensive
(having low blood pressure) individuals or patients
in shock. Inaccurate low results may occur for
individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood
glucose meters.
• For questions or concerns, contact Customer
Service: 1-800-429-5001 (9 am - 9 pm EST, Monday-
Saturday). At all other times or in case of emergency,
contact your healthcare professional.
Important Health-Related Information
Operating ranges
Temperature 50 - 104˚F (10 - 40˚C)
Relative humidity 10 - 90%
Hematocrit 20 - 60%
Product specifications
Measurement Range 20 - 600 mg/dL
Sample size Minimum 0.5 μL
Test time 5 seconds
Sample type Fresh capillary whole blood
Calibration Plasma-equivalent
Assay method Electrochemical
Battery life 1,000 tests
Power Two alkaline AAA batteries
Memory 500 test results
Size 3.90 x 2.21 x 0.75 in.
Weight 2.47 oz (with batteries)
Specifications
2 3

Step 1
Make sure the meter is turned off.
Press firmly on the battery cover and
slide in the direction of the arrow.
Then swing the battery cover open.
Step 2
Remove the used batteries and
insert the two new batteries. Close
the battery cover firmly.
Note: Removing the meter
batteries will not affect your
stored results. However, you
may need to reset your meter
settings. See page 14.
LiteTouch CareSens N Multi Test Strip
The LiteTouch CareSens N Voice Multi Blood Glucose
Monitoring System measures blood glucose quickly and
accurately. It automatically absorbs the small blood sample
applied to the narrow edge of the strip.
Safety Instructions for Using Test Strips
• All components that come into contact with blood
samples should be considered biohazards capable
of transmitting viral diseases between patients and
healthcare professionals.
• The LiteTouch CareSens N Multi Test Strips should be
used only with fresh capillary whole blood samples.
• Do not reuse test strips.
• Do not use LiteTouch CareSens N Multi Test Strips
beyond the expiration date. This may cause inaccurate
results.
• Test strips in new, unopened vials and test strips in
vials that have been opened can be used up until the
expiration date printed on the test strip box and vial
label as long as the test strips are used and stored
according to its storage and handling methods.
Insert
Contact bars
Gently push the test strip, with its
contact bars facing up, into the test
strip port of meter
Confirmation window
Check here to see whether sufficient
blood sample has been applied
Edge to apply blood sample
Apply blood sample here for testing
LiteTouch CareSens N Voice Multi Blood Glucose
Monitoring System
LiteTouch CareSens N Voice Multi BGMS includes the
following items:
 LiteTouch CareSens N Voice Multi Blood Glucose Meter
 User's Manual
 Quick Reference Guide
 Batteries (2)
LiteTouch CareSens N Voice Multi BGMS may include the
following items:
 LiteTouch CareSens N Multi Test Strips (10)
 Lancing Device
 Logbook
 Carrying Case
• Check all the components after opening the LiteTouch
CareSens N Voice Multi Blood Glucose Monitoring System
package. The exact contents are listed on the main box.
• The CareSens Control Solutions (Control A & B) are
necessary but not included. The CareSens Control
Solutions can be ordered separately. Please contact your
distributor or call MediCore.
Caution: Only auto-disabling, single use safety lancets
should be used with this system.
Inserting or Replacing the Batteries
Meter uses two AAA alkaline batteries. Before using
the meter, check the battery compartment and insert
batteries if empty. When the symbol appears on the
display while the meter is in use, the batteries should be
replaced as soon as possible. The test results may not be
saved if the batteries run out completely.
• Store test strips in a cool and dry place at a temperature
of 34-86˚F (1-30˚C).
• Keep test strips away from direct sunlight or heat and
do not freeze.
• Store test strips only in their original vial.
• Close the vial tightly after taking out a test strip for
testing and use the strip immediately.
• Handle test strips only with clean and dry hands.
• Do not bend, cut, or alter test strips in any way.
• For detailed storage and usage information, refer to the
LiteTouch CareSens N Multi Test Strip package insert.
• Keep the meter and testing supplies away from young
children.
• The test strip vial contains drying agents that are
harmful if inhaled or swallowed and may cause skin or
eye irritation.
LiteTouch CareSens N Voice Multi Blood
Glucose Meter
Data Port
Used to transfer data from the
meter to a computer with a
cable
SButton
Turns the meter
on/off, confirms
menu selections

Button
Selects or
changes
information
Display
Shows results
and messages
Test Strip Port
Insert test strip here

Button
Selects or
changes
information
Note: Data management software is only available for
single use patients.
Speaker
Announces each step
Test Strip Ejector
Slide down to discard
the used strips
07 08 09 10
02 03
04
05
12
13 14
06 11
alarm: appears when the time alarm has been set
mem: appears when test results stored in the memory
are displayed
ctl: appears during the control solution testing and
when the control solution test results are displayed
Test results: are displayed here
Blood insertion symbol: indicates meter is ready for
the application of a drop of blood or control solution
Temperature symbol: appears when the temperature
is displayed
Post-meal test flag: appears during post-meal testing
and when post-meal test results are displayed
Hypoglycemia symbol: appears when the test result
is below the hypoglycemic level
Post-meal alarm symbol: appears when the
post-meal alarm has been set
Mute symbol: appears only when the sound is set
to OFF
Battery symbol: indicates meter batteries are running
low and need to be replaced
mg/dL, mmol/L: unit for measuring blood glucose
Date / temperature
Time
LiteTouch CareSens N Voice Multi
Meter Display
01
02
03
04
05
06
09
10
11
12
13
14
07
08
Note: The unit of measurement for your LiteTouch
CareSens N Voice Multi Blood Glucose Meter is preset and
fixed in mg/dL.
01
4 5

Setting Up Your System
You should check and update the meter settings such as
time and date before using your meter or after changing
the meter batteries.
Press and hold the Sbutton for 3 seconds to enter the SET
mode. While you are setting the meter, current settings will
appear on the display. The meter will also announce each
function when the talking function is on. Press and hold

or

to scroll faster. Whenever you want to complete the
settings and exit from the SET mode, press and hold the S
button for 3 seconds again.
Adjusting Language, Date, Time, and Sound
Step 1 Entering the SET Mode
Press and hold the Sbutton for 3 seconds.
After all the segments flash across the
screen, SET is displayed on the screen. If
the talking function is on, the meter will
say "Set meter." Press the Sbutton again
to select a language.
Step 2 Selecting a Language
The meter has a bilingual talking
function that can be used as a verbal
aid for using the meter and hearing test
results. When you enter the language
selection mode for the rst time, L1 will
be blinking and the meter will announce
"Language Selection" in the default
language English. To select another
language (L2, Spanish), press

or

button. Press the Sbutton to
conrm the language and set the
year.
Step 3 Setting the Year
The meter will say "Set year" if the talking
function is on. Press

or

button
until correct year appears. Press and hold

or

to scroll faster. After setting the
year, press the Sbutton to confirm your
selection and set the month.
Step 4 Setting the Month
A number indicating the month will blink
on the bottom left corner of the screen. If
the talking function is on, the meter will
say "Set month." Press

or

button
until the correct month appears. Press
the Sbutton to confirm your selection
and set the date.
Step 5 Setting the Date
The meter will say "Set date" when the
talking function is on. Press

or

button until blinking number shows the
correct date. Press the Sbutton to confirm
the date and set the time.
Step 6 Setting the Time Format
The meter can be set in the AM/PM (12-
hour) or the 24-hour clock format. If the
talking function is on, the meter will say
"Set time 12-hour / 24-hour." Press

or

button to select a format. The AM/
PM is not displayed in the 24-hour format.
After selecting the format, press the S
button to set the hour.
Step 7 Setting the Hour
If the talking function is on, the meter will
say "Set hour." Press

or

button until
the correct hour appears. After setting the
hour press the Sbutton to confirm the hour
and set the minute.
Step 8 Setting the Minute
If the talking function is on, the meter will
say "Set minute." Press

or

button until
the correct minute appears. After setting the
minute, press the Sbutton to set the sound.
Step 9 Turning the Sound On/Off
A number showing the sound volume will blink and the
meter will say "Set volume." Press

or

button to adjust
the volume from 1 (lowest) to 3 (highest) or to turn the
sound off or the beep sound on.
When you select the beep On, the meter will beep instead
of announcing messages. To turn off the sound, press the S
button when OFF blinks on the display. Then the symbol
will appear on the display and the meter will be muted.
Press the Sbutton to save the setting and move to the
hypoglycemia (low blood glucose) indicator setting mode.
Note: symbol is displayed only when the sound is set to OFF.
Setting the Hypoglycemia Indicator
You can set the meter to let you know when your
test result indicates a possible low blood glucose
(hypoglycemia). You can also select the hypoglycemia
level from 60 to 20 mg/dL.
When you enter the hypoglycemia
indicator setting mode, the symbol
and HYPo will blink. If the talking function
is on, the meter will say "Set hypoglycemia
indicator." On pressing

or

, the screen
will display On or OFF. Press Sbutton to set
your hypoglycemia level if you choose On.
The screen will return to step 2, language
selection mode, if you choose OFF.
Caution: Ask your healthcare
professional to help you decide what
your hypoglycemia level is before
setting your hypoglycemic level.
St ep 11 Setting Your Hypoglycemic Level
The hypoglycemic level can be set from 60 to 20 mg/dL.
To set your hypoglycemic level, press

or

button
until the level you want appears. Press the Sbutton to
confirm. Then the screen will return to step 2, language
selection mode. See page 14.
Step 12 Exiting from Set Mode
After completing the meter settings, press and hold the
S button for 3 seconds to confirm all your selections
and exit from SET mode. If the talking function is on,
the meter will announce the set date and time for your
confirmation.
Step 10 Turning on the Hypoglycemia Indicator
Checking the System
You should check your meter and test strips
using CareSens Control Solution (Control
A and B). The CareSens Control Solutions
contain known amounts of glucose and
are used to check that the meter and the
test strips are working properly. The test
strip vials have CareSens Control Solution
ranges printed on their labels. Compare the
result displayed on the meter to the control
solution range printed on the test strip vial.
Before using a new meter or a new vial of test strips,
you should conduct a control solution test following
the procedure on page 20 with two different levels of
solutions (Control A and B).
Notes:
• Use CareSens Control Solutions only.
• Check the expiration dates printed on the bottle. When
you first open a control solution bottle, record the
discard date (date opened plus three (3) months) in the
space provided on the label.
• Make sure your meter, test strips, and control solutions
are at room temperature before testing. Control
solution tests must be done at room temperature (68 -
77˚F, 20 - 25˚C).
• Before using the control solution, shake the bottle,
discard the first 1 or 2 drops, and wipe the tip clean.
• Close the control solution bottle tightly and store at a
temperature of 46 - 86˚F (8 - 30˚C).
You should do a control solution test:
• When you want to practice the test procedure using the
control solution instead of blood;
• When using the meter for the first time;
• Whenever you open a new vial of test strips;
• If the meter or test strips do not function properly;
• If your symptoms are inconsistent with the blood
glucose test results and you feel that the meter or test
strips are not working properly;
• If you drop or damage the meter;
• When using the meter for blood glucose test after any
disinfection procedure.
6 7

Step 2
While the blood symbol blinks, press
and hold the

button for 3 seconds
until the ctl appears on the display. If
the talking function is on, the meter
will say "Control solution test. Please
apply control solution onto the test
strip ."
Step 1
Insert a test strip into the meter's test
strip port, with the contact bars facing
upwards. Gently push the test strip into
the port until the meter automatically
turns on and the symbol appears. If
the talking function is on, the meter will
say "Blood glucose test. Please apply
blood onto the test strip."
Control Solution Testing
Step 3
Shake the CareSens Control Solution
bottle well before each test. Remove
the cap and squeeze the bottle to
discard the first 1 or 2 drops.
Then wipe the tip with a clean tissue
or cloth. While the symbol blinks,
apply the control solution to the
narrow edge of the test strip until
the meter beeps. Make sure the
confirmation window of test strip fills
completely.
Step 4
A test result will appear after the meter
counts down from 5 to 1. If the talking
function is on, the test result will be
announced. If you missed step 2, you
can mark the test result as a control
solution test result by pressing and
holding the

button for 3 seconds
until the ctl appears on the display.
When the ctl is displayed, the result is
stored in the meter's memory but is not
included in the averages.
Note: The meter will switch off if the control solution
sample is not applied within 2 minutes of the
symbol appearing on the screen. If the meter turns off,
remove the strip, reinsert, and start from step 2.
Caution: The ranges printed on the test strip vial are for
CareSens Control Solutions only. They do not have any
connection to your blood glucose level.
Step 5
Compare the result displayed on the
meter to the range printed on the
test strip vial. The result should fall
within that range.
Step 6
Slide the test strip ejector
button to discard the used
test strip safely in a biohazard
approved container.
The ranges depicted on the vials are examples only.
Comparing the Control Solution Test Results
The test result of each control solution should be within
the range printed on the label of test strip vial. Repeat the
control solution test if the test result falls outside of this
range. Out of range results may occur due to the
following factors:
If results continue to fall outside the range printed on
the test strip vial, the LiteTouch CareSens N Voice Multi
Meter and LiteTouch CareSens N Multi Test Strip may not
be working properly. Do not use your system and contact
Customer Service: 1-800-429-5001 (9 am - 9 pm EST,
Monday - Saturday).
Note: The CareSens N Control Solutions can be
purchased separately. Contact yourDistributor.
• When the control solution bottle was not
shaken well,
• When the meter, test strip, or the control
solution were exposed to high or low
temperatures,
• When the first drop of the control solution
was not discarded or the tip of the vial was
not wiped clean,
•
When the meter is not functioning properly.
• When the control solution is past the
expiration date printed on the bottle,
• When the control solution is past its
discard date (the date the bottle was
opened plus three (3) months),
• When the control solution is contaminated.
Situations Actions
Repeat the
control solution
test by referring
to the “Notes” on
page 19.
Discard the used
control solution
and repeat the
test using a new
bottle of control
solution.
CAUTION : To reduce the chance of infection
Before performing a blood glucose test, observe
the following safety precautions:
• All components that come into contact with blood
samples should be considered to be biohazards
capable of transmitting viral diseases between patients
and healthcare professionals.
• A new pair of clean gloves should be worn by the user
before testing each patient.
• Wash hands thoroughly with soap and water before
putting on a new pair of gloves and performing the
next patient test.
• Use only an auto-disabling, single-use safety lancet
for each patient.
• The meter should be cleaned and disinfected after
use on each patient. See the cleaning and disinfection
section on page 40.
Blood Glucose Testing
For more information, please refer to the following
guidelines: Preparing the Lancing Device
1. "Biosafety in Microbiological and Biomedical
Laboratories (BMBL)", http://www.cdc.gov/biosafety/
publications/bmbl5/
2. "Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline-Third Edition"
Clinical and Laboratory Standards Institute (CLSI)
M29-A3.
You will need a lancet in order to collect a blood sample.
Only an auto-disabling, single use safety lancet should
be used. The auto-disabling, single use safety lancets
can be purchased from your distributor. Please read the
instructions provided by the manufacturer of lancet
before using it.
Step 1
Wash hands and the sample site
with soap and warm water. Rinse
and dry thoroughly.
Wear appropriate protective gear
such as disposable gloves.
Step 2
Insert a test strip with the contact bars facing up into the
meter’s test strip port. Push the strip gently into the strip
port until the meter automatically turns on and the
symbol appears. If the talking function is on, the meter
will say "Blood glucose test. Please apply blood onto the
test strip."
Preparing the Meter and Test Strip
Step 3
If you want to attach a post-meal flag ( ) to
a test result, press and hold the

button
for 3 seconds after inserting the test strip.
The post-meal flag ( ) and the symbol
will appear on the screen. If the talking
function is on, the meter will say "Post-meal
test. Please apply blood onto the test strip."
The test result will also be displayed with
the post-meal flag ( ).
If you do not want to save the result as a post-meal test,
move on to Step 4 after Step 2. If you want to delete the
post-meal flag ( ) that you have attached, press and hold
the

button for 3 seconds again before applying the
blood sample or when the test result is displayed just
after testing.
Flagging Post-Meal Test Results
LiteTouch CareSens N Voice Multi Blood Glucose Meter
allows you to flag a result of a post-meal test with
symbol. The post-meal flag ( ) can be attached and
deleted just before applying the blood sample or when
the test result is displayed just after testing. Once the
test result is saved with the post-meal flag ( ), it cannot
be deleted.
Step 4
Obtain a blood sample using a safety lancet. Place the
safety lancet against the sampling site in the direction
of the arrow. The best puncture sites are areas on the
middle or ring fingers.
Remove the safety lancet from the finger. Wait a few
seconds for a blood drop to form. A minimum volume of
0.5 microliter is needed to fill the confirmation window.
Applying the Blood Sample
8 9

Step 5
After the symbol appears
on the screen, apply the blood
sample to the narrow end of
the test strip until the meter
beeps. If the blood sample
does not fill the confirmation
window completely, an Er4
message may appear because
of abnormal viscosity or
insufficient volume. If the
talking function is on, the
meter will say "Error four. The
sample was not enough or
too thick."
Then discard the test strip,
insert a new one, and apply the
blood sample again after
symbol appears on the screen.
It is recommended that the
application of blood sample
to the test strip be performed
virtually vertical to the sample
site as shown in the diagram.
Good
Sample
Insufficient
Sample
Approximate Size
Step 6
The test result will appear after the
meter counts down from 5 to 1. If
the talking function is on, the result
will be announced. The result will
be automatically stored in the meter
memory.
Note: The meter may switch off if the blood sample
is not applied within 2 minutes of the symbol
appearing on the screen. If the meter turns off, remove
the strip, reinsert, and start from step 2.
Step 7
Discard the used test strip
safely in a biohazard approved
container by pushing up the
test strip ejector. If the test strip
is removed after the test result
is displayed, the meter will
automatically turn off after 3
seconds.
Alternative Site Testing
What is AST (Alternative Site Testing)?
When someone tests their glucose, they usually take the
blood sample from the tip of the finger. However, since
there are many nerve endings in the fingertip, it can be
quite painful. When doing a glucose test, using different
parts of the body such as the forearms, palms, thighs, and
calves can reduce the pain during testing. This method of
testing with different parts of the body is called Alternative
Site Testing. While AST may reduce the pain during testing,
it may not be simple for everyone and the following
precautions should be observed during testing.
Alternative Site Blood Sampling
(forearm, palm, thigh, calf)
Select a clean, soft, and fleshy sample site area free of visible
veins and hair and away from bones. Gently massage the
sample site to help blood circulation to minimize result
differences between fingertip and alternative site sampling.
Place cocked lancing device against the site. Press the
release button. Massage the site to obtain a round drop (at
least 0.5 μL) of blood. Apply test strip tip to blood sample.
Alternative Sites for Testing
Things to Know When Using AST
Please read the following before testing at alternative sites
(forearms, palms, thighs, and calves). The capillary whole
blood of the fingertips reflects changes in glucose levels
more rapidly than in alternative sites. The test results from
the fingertip testing and AST may differ due to factors such
as lifestyle and ingested food which affect glucose levels.
Caution: AST results should never be used to calibrate
Continuous Glucose Monitoring Systems nor entered
into an insulin dosing calculator or pump for dosing
recommendations.
Acceptable Situations for AST
• Fasting period
• Before a meal
Situations Requiring Fingertip Test
• When the glucose levels are rapidly increasing,
such as during the two hours after a meal or
exercise
• When sick or when glucose levels seem quite
lower than test value
• When hypoglycemia is not well recognized
• When insulin has the biggest effect
• Two hours after an insulin injection
AST Precautions
• Do not ignore the symptoms of hyperglycemia or
hypoglycemia.
• When the results of the test do not reflect the way
patient feels, retest using the fingertip. If the fingertip
result still does not reflect the way patient feels on
retesting, please consult the patient's healthcare
provider.
• Do not rely on AST results for making treatment
decisions.
• The amount of glucose in alternative sites differs from
person to person.
• Before using AST, please consult the patient's
healthcare provider.
Note: Results from alternative site and fingertip
samples may differ from each other, as there is a time
lag for the glucose levels to reach the same value. Use
a fingertip sample if you suffer from hypoglycemia or
have experienced hypoglycemic shock or symptoms.
Note: If the sample drop of blood runs or spreads
due to contact with hair or with lines on your palm,
do not use that sample. Try puncturing again in a
smoother area.
Note: If messages for hyperglycemia or hypoglycemia
are displayed, even if patient does not have those
conditions, please contact Customer Service: 1-800-
429-5001 (9 am - 9 pm EST, Monday - Saturday).
Lo Message
Lo appears when a test result is less than
20 mg/dL and indicates severe
hypoglycemia (very low glucose levels). If
the talking function is on, the meter will
say "Your blood glucose reading is below
20 mg/dL."
If Lo is displayed again upon retesting,
please contact the patient's healthcare
provider immediately.
Transferring Test Results
Test results stored in LiteTouch CareSens N
Voice Multi Blood Glucose Meter can be
transferred from the meter to a computer
using SmartLog software and cable. The
'Pc' is displayed when the data cable
connects the meter with computer. (For
single patient use only.)
For more information, contact Customer
Service at: 1-800-429-5001.
Meter Memory
The LiteTouch CareSens N Voice Multi Blood Glucose
Meter can save up to 500 test results with time, date, and
temperature. If the memory is full, the oldest test result
will be deleted and the latest test result will be stored.
The LiteTouch CareSens N Voice Multi Blood Glucose
Meter calculates and displays the averages of total test
results, pre-meal test (Pr) results, and post-meal test ( )
results from the last 1, 7, 14, 30, and 90 days.
Hi and Lo Messages
Hi Message
The LiteTouch CareSens N Voice Multi
Blood Glucose Meter displays results
between 20 - 600 mg/dL. Hi appears
when the blood glucose level is greater
than 600 mg/dL and indicates severe
hyperglycemia (much higher than normal glucose
levels). If the talking function is on, the meter will say
"Your blood glucose reading is above 600 mg/dL."If
Hi is displayed again upon retesting, please contact
the patient's healthcare provider immediately.
10 11

Step 1
Press the Sor

button to turn on the
meter. If the talking function is on, the
meter will say "Memory recall." The
current date and time will be displayed
at the bottom of the screen followed
by the 1 day average value and the
number of the test results saved within
the current day.
Viewing Past Test Averages
Step 2 Viewing Averages
Press the

to view the 7, 14, 30, and 90-day average
values and the number of tests performed for the
test period.

button

button
Average
(1, 7, 14, 30,
90 days)
The number of
tests within
the current day
Step 3 Viewing Pre-Meal Averages
Continue to press the

button to view the 1, 7, 14, 30,
and 90-day pre-meal average values and the number
of tests performed pre-meals for the test period. The
pre-meal test averages appear with the Pr symbol.

button

button
Pre-meal
average
(1, 7, 14, 30,
90 days)
Step 4 Viewing Post-Meal Averages
Continue to repeatedly press the

button; the 1, 7,
14, 30, and 90-day post-meal average values and the
number of tests performed post-meals with the
symbol for the test period will appear on the screen.
Step 5
Use the

button to scroll back through the averages seen
previously. To turn off the meter, press the Sbutton.

button

button
Pre-meal
average
(1, 7, 14, 30,
90 days)
Step 1
Press the Sor

button to turn the meter
on. The current date and time will be
displayed on the bottom of the screen
followed by the 1 day average value and
the number of the test results saved within
the current day.
Viewing Test Results
The number of
tests within
the current day
Step 2
Use the

button to scroll through the stored test
results, starting from the most recent and ending with the
oldest. Press the

button to return to the result seen
previously. The test date and the recorded temperature
will display alternately. After checking the stored test
results, press the Sbutton to turn off the meter.

button

button
Step 1 Setting the PP2 Alarm On
Without inserting a test strip, press and hold the

button for 3 seconds to set the post-meal alarm. PP2,
the symbol, and On will be displayed. If the talking
function is on, the meter will say "Post-meal alarm is on."
The screen will then automatically change to the memory
check mode. At this time, the symbol, indicating that
the PP2 alarm has been set, will be displayed on the
screen.
Setting the Alarm Function
Setting the Post-Meal Alarm (PP2 Alarm)
Four types of alarms can be set in the LiteTouch CareSens N
Voice Multi Blood Glucose Meter: one post-meal alarm (PP2
alarm) and three time set alarms (alarm 1 - 3). The PP2 alarm
goes off 2 hours after setting the alarm. The alarms ring
for 15 seconds and can be silenced by pressing

,

or S
button or by inserting a test strip.
Step 2 Setting the PP2 Alarm OFF
To turn off the PP2 alarm, press and hold the

button
for 3 seconds. PP2, the symbol, and OFF will appear
on the screen. If the talking function is on, the meter
will say "Post-meal alarm is off." Then the screen will
change automatically to the memory check mode
without symbol displayed.
icon disappears
Step 1
Without inserting a test strip, press

and the Sbutton simultaneously for 3
seconds to enter the time alarm mode.
While OFF blinks on the screen, alarm 1
will be displayed. If the talking function
is on, the meter will say "Set alarm one."
Setting the Time Alarms (Alarm 1 - 3)
Step 2
On pressing

, alarm 1 is set and On is
displayed on the screen. Press

again
to cancel alarm 1 and OFF will blink on
the screen.
Step 3
Press

to adjust the hour of alarm 1.
A number representing the hour will
blink on the screen. Press

to set the
hour. Press

to set the minute.
Step 4
On pressing

, the number indicating the
minute will start blinking. Press

to set
the minute.
Step 5
Press the Sbutton to finish and to enter
the alarm 2 mode.
Repeat steps 2 to 5 to set the remaining
time alarms (alarm 2 and 3).
Step 6
Press and hold the Sbutton for 3 seconds to finish and
turn the meter off.
Caring for Your System
• To minimize the risk of transmission of blood-borne
pathogens, the cleaning and disinfection procedure
should be performed as recommended in the
instructions below.
• After disinfection, users should remove gloves and wash
hands before testing the next patient.
The cleaning procedure is needed to clean dirt as well
as blood and other body fluids off the exterior of the
meter before performing the disinfection procedure.
The disinfection procedure is needed to prevent
transmission of blood-borne pathogens.
• For the meter, this cleaning and disinfection procedure
should be performed after use on each patient.
Cleaning and Disinfection:
Note: The life span of a LiteTouch CareSens N Voice
Multi Blood Glucose Meter is 3 years. We recommend
cleaning and disinfecting the meter after the use
on each patient. We have validated a total of 10,950
cleaning and disinfecting cycles (10,950 cleaning and
10,950 disinfection cycles) to represent after each
use cleaning and disinfecting over the use life of the
LiteTouch CareSens N Voice Multi Blood Glucose Meter.
1 cleaning and 1 disinfection cycles per each use *
10 uses per day * 365 days per year * 3 years = 10,950
cleaning and 10,950 disinfection cycles
12 13

• For a list of Environmental Protection Agency (EPA)
registered disinfectants effective against HIV, Hepatitis
C, and Hepatitis B virus can be found at the following
website: http://www.epa.gov/oppad001/list_d_
hepatitisbhiv.pdf )
➂
Cleaning and Disinfection Procedures:
Open the cap of the
(Approved EPA)
Germicidal Wipes
container and
pull out 1 towelette
and close the cap.
Wear appropriate protective gear such as
disposable gloves.
* Cleaning
* Disinfecting
Pull out 1 new towelette and wipe the entire surface
of the meter 3 times horizontally and 3 times vertically
using the new towelette to remove blood-borne
pathogens.
Wipe the entire surface of the meter 3 times horizontally
and 3 times vertically using one towelette to clean
blood and other body fluids.
Dispose of the used towelette in a trash
bin. The meter should be cleaned prior
to each disinfection step.
➀
➃
➄
➁
Front Back Both sides
➆Allow exteriors to remain wet for 1 minute, then wipe the
meter using a dry cloth.
➅ Dispose of the used towelette in a trash bin.
➇After disinfection, the user's gloves should be removed to
be thrown away and hands washed before proceeding to
the next patient.
* After the cleaning and disinfection procedure, the control
solution should be tested to confirm that the meter
works properly before using the meter. Control solution
tests should be performed with two different levels of
solutions (Control A & B). Verify that the test results are
within the range printed on the test strip vial. See page
19 for how to do a control solution test.
dry cloth
Note:
If any of the following deterioration signs appear after
pre-cleaning or disinfecting, please stop using the system
and contact Customer Service: 1-800-429-5001 (9 am - 9
pm EST, Monday - Saturday).
• When the inscriptions on the exterior of the meter have
been removed,
• When the color of the meter has changed or faded,
• When cracks or roughness develop on the meter,
• When a part of the segment on the meter display does
not flash,
• When control solution test results do not fall within the
stated range on the test strip vial.
For more information, please refer to the following
references: "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/Medical Devices/Safety/
AlertsandNotices/ucm224025.htm "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
• Do not expose the meter to direct sunlight or heat for
extended periods of time.
• Do not let dirt, dust, blood, or water enter into the
meter’s test strip port.
• Do not drop the meter or subject it to strong shocks.
• Do not try to fix or alter the meter in any way.
• Keep the meter in a cool and airy place.
• Store all meter components in the carrying case to
prevent loss.
Caution: Storage and Handling
Note: You can get additional information or technical
assistance by calling our Customer Service Center:
1-800-429-5001 (9 am - 9 pm EST, Monday - Saturday).
Caution:
• Do not get fluids inside the meter through the
test strip port, data transmission port, or battery
compartment. Never immerse the meter or hold
it under running water because this will damage
the meter.
Message What is said
"Error 1. Used
test strip."
"Error 2. The
sample has
been applied
before the
blood symbol
appeared."
A used test strip
was inserted.
The blood or
control solution
sample was
applied before
the
symbol
appeared.
Remove the strip
and insert a new
test strip.
Repeat the test
with a new test
strip and wait until
the
symbol
appears before
applying the
blood or control
solution sample.
What it means What to do
Understanding Error and Other Messages
N/A
"Error 4. The
sample was
not enough or
too thick."
The thermometer
of meter is not
stabilized yet.
The blood
sample has
abnormally high
viscosity or
insufficient
volume.
Retry the test
after about 30
minutes for the
thermometer to
be stabilized.
Repeat the test
using a new test
strip.
"Error 5. Strip
insertion
error. Please
insert a
CareSens N
strip properly."
This error
message may
appear when
the wrong blood
glucose test strip
is used instead
of the CareSens
N Multi test strip.
Repeat the test
with a CareSens N
Multi test strip.
Insert the strip
with the contact
bars facing up,
and push in
gently until the
meter turns on.
Note: If the error messages persist, contact Customer Service:
1-800-429-5001 (9 am - 9 pm EST, Monday - Saturday).
Message
What is said What it means What to do
"Error 6 / Error 7
/ Error 8 / Error 9.
Meter failure."
There is a
problem with the
meter.
Do not use the
meter. Contact
Customer Service:
1-800-429-5001.
Message What is said
"The room
temperature is
too low."
"The room
temperature is
too high."
The temperature
during the test is
below the
operating range.
The temperature
during the test is
above the
operating range.
What it means What to do
Move to an area
where the
temperature is
within the
operating range
(50-104˚F) and
repeat the test
after the meter
and test strips
have reached a
temperature
within the
operating range.
14 15

Problem Troubleshooting
• Check whether the test strip is inserted
with the contact bars facing up. Check
if the strip has been inserted
completely into the test strip port.
• Check if the appropriate test strip was
used.
• Check if the batteries are inserted
correctly.
• Replace the batteries.
• Check if the confirmation window is
filled adequately.
• Repeat the test after inserting a new
test strip.
• Repeat the test after inserting a new
test strip.
• Check the validity period of the test
strip.
• Perform the control solution test.
The display is
blank even after
inserting a test
strip.
The test does not
start even after
applying the blood
sample on the test
strip.
The test result does
not match the way
you feel.
General Troubleshooting
Note: If the problem is not resolved, please contact Customer
Service: 1-800-429-5001 (9 am - 9 pm EST, Monday - Saturday).
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
54/93 (58%) 82/93 (88%) 93/93 (100%) 93/93 (100%)
Within ± 5 mg/dL
14/17 (82%) 17/17 (100 %) 17/17 (100 %)
Within ± 10 mg/dL Within ± 15 mg/dL
Performance Characteristics
The performance of LiteTouch CareSens N Voice Multi Blood
Glucose Monitoring System has been evaluated in laboratory
and clinical tests.
Accuracy: The LiteTouch CareSens N Voice Multi BGM System
is calibrated to yield results equivalent to plasma glucose
concentrations. The accuracy of the LiteTouch CareSens N
Voice Multi Blood Glucose Monitor System (Model GM505UAA)
was tested by comparing blood glucose results obtained by
patients with those obtained using a YSI Model 2300 Glucose
Analyzer, a lab instrument. The results below were obtained by
diabetic patients at clinic centers.
Slope 1.023 1.032
Y-intercept -1.86 mg/dL -3.63 mg/dL
Correlation coefficient(r) 0.995 0.985
Number of sample 110 105
Range tested 30 - 485 mg/dL 67 - 413 mg/dL
Obtained by healthcare
professionals
Obtained by
lab users
Accuracy results for glucose concentration < 75 mg/dL
Accuracy results for glucose concentration ≥ 75 mg/dL
Precision: Precision studies were performed in a laboratory
using the LiteTouch CareSens N Voice Multi BGMS.
This study shows that there could be variation of up to 4.1%.
Within Run Precision
Total Precision
SD = 1.2 mg/dL
CV = 2.4%
CV = 2.3%
SD = 1.9 mg/dL
SD = 3.2 mg/dL
CV = 4.1%
CV = 2.6%
CV = 2.8%
35 mg/dL
116 mg/dL
324 mg/dL
38 mg/dL
86 mg/dL
125 mg/dL
189 mg/dL
334 mg/dL
Blood avg.
Blood avg.
Blood avg.
Blood avg.
Blood avg.
Control avg.
Control avg.
Control avg.
Alternative Sites Testing Evaluation

Comparison of results using various AST sites with the
results of YSI measurements.
Alternative site test results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
Fingertip
Forearm
Palm
Thigh
Calf
1/2 (50.0%)
1/2 (50.0%)
2/2 (100%)
1/2 (50.0%)
1/2 (50.0%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
27/48 (56 .3%)
19/48 (39.6%)
28/48 (58.3%)
17/4 8 (35.4%)
27/48 (56 .3%)
48/48 (100%)
48/48 (100%)
48/48 (100%)
48/48 (100%)
48/48 (100%)
46/48 (95.8%)
42/48 (87.5%)
38/48 (79.2%)
36/48 (75.0%)
46/48 (95.8%)
48/48 (100%)
47/48 (97.9%)
46/48 (95.8%)
46/48 (95.8%)
48/48 (100%)
Alternative site test results for glucose concentration ≥ 75 mg/dL
Fingertip
Forearm
Palm
Thigh
Calf
Within ±5% Within ±10% Within ±15% Within ±20%
Warranty Information
Manufacturer's Warranty
MediCore warrants that the LiteTouch CareSens N Voice
Multi Blood Glucose Meter shall be free of defects in
material and workmanship in normal use for a period
of three (3) years. The meter must have been subjected
to normal use. The warranty does not cover improper
handling, tampering, use, or service of the meter. Any
claim must be made within the warranty period.
MediCore will, at its discretion, repair or replace a defective
meter or meter part that is covered by this warranty. As a
matter of warranty policy, MediCore will not reimburse the
consumer’s purchase price.
Obtaining Warranty Service
To obtain warranty service, you must return the defective
meter or meter part along with proof of purchase to your
nearest MediCore Authorized Warranty Station.
16 17

Write "Yes”if the meter was cleaned and “No”if it was not.
Range is printed on the test strip vial label.
The control solution must be discarded by either the expira-
tion date (printed next to the use by symbol on the bottle)
or the discard date, whichever comes rst. Count forward 90
days from the date that you open the bottle of CareSens N
Control Solution. This is the discard date. Write the discard
date on the CareSens N Control Solution bottle.
Range is printed on the test strip vial label.
The control solution must be discarded by either the expira-
tion date (printed next to the use by symbol on the bottle)
or the discard date, whichever comes rst. Count forward 90
days from the date that you open the bottle of CareSens N
Control Solution. This is the discard date. Write the discard
date on the CareSens N Control Solution bottle.
The test strip should be discarded by either the expiration
date (printed next to the use by symbol on the vial) or
the discard date, whichever comes rst. Count forward 90
days from the date that you open a new vial of LiteTouch
CareSens N Multi Test Strips. This is the discard date. Write
the discard date on the LiteTouch CareSens N Multi Test
Strips vial.
LiteTouch CareSens N Control Record Chart (Example)
LiteTouch CareSens N Control Record Chart (Example for making additional copies)
*Should see comments section below
*Should see comments section below
18 19

Notes
20