iSens KetoSens User manual

Table of Contents
Information
Important Information: Read This First!..............................................4
Specifications .....................................................................................8
KetoSens Blood β-Ketone Monitoring System ..................................9
Inserting or Replacing the Batteries .................................................10
KetoSens Blood β-Ketone Test Strip ...............................................11
KetoSens Blood β-Ketone Meter .....................................................13
KetoSens Blood β-Ketone Meter Display.........................................14
Preparation
Setting Up Your System...................................................................15
Adjusting the Date and Time.........................................................15
Setting the Sound On/OFF............................................................18
Turning on the Strip Expiration Date Indicator..............................19
Setting the Strip Expiration Date Indicator.......................................20
Checking the System .......................................................................21
Control Solution Testing ...............................................................22
Comparing the Control Solution Test Results ..............................24
Testing
Using the Lancing Device.................................................................25
Preparing the Lancing Device .......................................................26
Preparing the Meter and Test Strip...............................................28
Applying Blood Sample.................................................................28
Discarding Used Lancets..............................................................30
HI Message.......................................................................................32
Additional Functions
Meter Memory ..................................................................................33
Viewing Test Results Stored in the Meter’s Memory....................33
Setting the Alarm Function...............................................................35
Setting the Time Alarms (alarm 1–3) .............................................35
Caring for Your System ....................................................................37
Maintenance
Understanding Error Messages........................................................42
General Troubleshooting ..................................................................45
Performance Characteristics ............................................................46
Warranty Information........................................................................48

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Important Information: Read This First!
Information
Intended use:
The KetoSens Blood β-Ketone Monitoring System is
intended for the quantitative measurement of β-Ketone
(beta-hydroxybutyrate) level in capillary whole blood
drawn from the fingertip. The KetoSens Blood β-Ketone
Monitoring System is intended for self-testing outside the
body (in vitro) by people with diabetes at home as an aid to
monitor the effectiveness of diabetes control. The system
is not intended for use in the diagnosis of or screening for
diabetes mellitus and is not intended for use on neonates.
This system is intended to be used by a single person and
should not be shared.
The KetoSens Blood β-Ketone Test Strips work with the
KetoSens Blood β-Ketone Meter to quantitatively measure
Blood β-Ketone in capillary whole blood samples drawn
from the finger.
The KetoSens Control Solutions are intended for use with
the KetoSens Blood β-Ketone meter and KetoSens Blood
β-Ketone test strip to check that the meter and the test
strip are working together properly and that the test is
performing correctly.
• Please use this device only for the intended use
described in this User's Manual.
• Please follow the suggested cleaning and disinfection
procedures described in this User's Manual.
To receive safe and optimum system benefits, please read
the entire manual contents before using the system.
Important Safety Information:
• 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 pre-cleaning and disinfection.
• “FDA Public Health Notification: Use of Fingerstick
Devices on More than One Person Poses Risk
for Transmitting Bloodborne Pathogens: Initial
Communication” (2010) http://wayback.archive-it.
org/7993/20170111013014/http://www.fda.gov/
MedicalDevices/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
• KetoSens Blood β-Ketone Test Strips are intended
for self-testing only. They should be disposed of in an
appropriate container immediately after use.

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Limitations
• Do not use for diagnosis of or screening for diabetes
mellitus.
• The system should not be used to test neonates.
• Do not test samples other than fresh capillary whole
blood obtained from the fingertip.
• Do not use the system at altitudes above 10,000 feet
(3000 meters).
• Do not use when hematocrit is outside the acceptable
hematocrit range for testing of 20 % to 55 %.
• Severe dehydration (excessive water loss) may cause
inaccurate results. If you believe you are suffering from
severe dehydration, consult your healthcare professional
immediately.
• For in vitro diagnostic use only
• Critically ill patients should not be tested with this device.
• Inaccurate results may occur in severely hypotensive
individuals or patients in shock.
• Incorrect result may occur in individuals who are
dehydrated.
• The meter and lancing device are for single patient use.
Do not share these items with anyone, including other
family members! Do not use on multiple patients!
• Do not reuse; each test strip is for single use only.
• Do not use when humidity is higher than 90 % and lower
than 10 %, as extremes in humidity may affect results.
• For single patient use only.
• For over-the-counter use
Important Information
• The KetoSens Blood β-Ketone Monitoring System
is intended for self-testing outside the body (in vitro
diagnostic use).
• β-Ketone in blood samples reacts with the chemical in
the test strip to produce a small electrical current. The
KetoSens meter detects the electrical current which
reflects the amount of β-Ketone in the blood sample.
• The KetoSens Blood β-Ketone Meter is designed to
minimise code related errors in monitoring by using
the no-coding function.
• The KetoSens Blood β-Ketone Meter should be used
only with the KetoSens Test Strips.
If you need assistance, please contact Customer Service:
1-800-429-5001 Mon–Sat, 9 am–9 pm EST. At all other
times or in case of emergency, contact your healthcare
professional or emergency medical response.
This device is not intended for use in healthcare or
assisted-use settings such as hospitals, physician offices
or long-term care facilities because it has not been cleared
by the FDA for use in these settings, including for routine
assisted testing or as part of glycemic control procedures.
Use of this device on multiple patients may lead to the
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.

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Specifications
Product specifications
Operating ranges
Measurement range 0.1–8.0 mmol/L
Sample size Minimum 0.5 µL
Test time 8 seconds
Sample type Fresh capillary whole blood
(fingertip)
Assay method Electrochemical Amperometry
Battery life 3,000 test results
Power Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory 1,000 test results
Size 106 x 58 x 17 (mm)
Weight 71.8 g (with batteries)
Temperature 50–104 ˚F (10–40 ˚C)
Relative humidity 10–90 %
Hematocrit 20–55 %
KetoSens Blood β-Ketone Monitoring System
The KetoSens Blood β-Ketone Control Solution Level A and
B are sold separately and can be purchased by contacting
Customer Service.
• Check all the components after opening the KetoSens
blood β-Ketone monitoring system package. The exact
contents are listed on the main box.
• The cable for data management software can be ordered
separately. Please contact Customer Service: 1-800-429-
5001 Mon–Sat, 9 am–9 pm EST.
KetoSens BKM System includes the following items:
* KetoSens Blood β-Ketone Meter
* User's Manual
* Quick Reference Guide
* Batteries (2)
KetoSens BKM System may include the following items:
* KetoSens Blood β-Ketone Test Strips
* Lancets
* Lancing Device
* Logbook
* Carrying Case
Storage/Transport conditions
Temperature
Glucose Meter
(with batteries) 32–122 ˚F (0–50 ˚C)
Test strip 34–86 ˚F (1–30 ˚C)
Control solution 46–86 ˚F (8–30 ˚C)
Relative humidity Test strip 20–80 %

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The KetoSens Meter uses two 3.0 V lithium 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.
Inserting or Replacing the Batteries
Step 1
Make sure the meter is turned off. Push
the cover in the direction of the arrow to
open the battery compartment.
Step 2
Remove the old batteries one by one by
lifting with the index finger and pulling it
out with your thumb and index finger as
shown in the figure on the right. Insert
two new batteries with the + side facing
up and make sure the batteries are
inserted firmly.
Step 3
Place the cover on the battery
compartment. Push down until you hear
the tab click into place.
Note: Removing the meter batteries will not affect your
stored results. However, you may need to reset your
meter settings. See page 15.
KetoSens Blood β-Ketone Test Strip
The KetoSens blood β-Ketone monitoring system measures
blood β-Ketone quickly and accurately. It automatically
absorbs the small blood sample applied to the narrow edge
of the strip.
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
Insert

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Warning:
• The KetoSens test strip should be used only with fresh
capillary whole blood samples drawn from the fingertip.
• Do not reuse test strips.
• Do not use test strips past the expiration date.
• Test strips in new, unopened foil packet can be used up
until the expiration date printed on the foil packet if the test
strips are used and stored according to its storage and
handling methods.
• Store foil packet in a cool and dry place between 39–86 ˚F
and 20–80 % Relative Humidity.
• Keep the foil packet of test strips away from direct sunlight
or heat.
• Store unused test strips in their original foil packet to avoid
damage or contamination.
• Open the foil packet to take out a test strip for testing and
use the test strip immediately. Do not use the test strip if
the foil is damaged or torn.
• 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
KetoSens test strip package insert.
• Keep the meter and testing supplies away from young children.
The test strips and foil packet may cause choking hazards.
Note: You can get more safety information at FDA Public Health
Notification (http://wayback.archive-it.org/7993/20170111013014/
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm) or at CDC Clinical Reminder (http://www.cdc.
gov/injectionsafety/Fingerstick-DevicesBGM.html).
KetoSens Blood β-Ketone Meter
Data Port
Used to transfer data
from the meter to a
computer with
a cable
◀,▶Button
Turns the meter
on, selects
or changes
information
Display
Shows results,
messages
S Button
Turns the
meter on/off,
confirms menu
selections,
and changes
information
Test Strip Port
Insert test strip
here
Note:
• The unit of measurement is fixed and it cannot be
changed by the user.
• The cable for data management software can be ordered
separately. Please contact Customer Service: 1-800-429-
5001 (9 am–9 pm EST, Monday–Saturday).
Test Strip
Ejector
Slide down to
discard the used
strips

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Note: It is recommended to check if the display screen on
the meter matches the illustration above every time the
meter turns on. Do not use the meter if the display screen
does not exactly match the illustration as the meter may
show incorrect results.
01 Memory recall mode: appears
when test results stored in the
memory are displayed
02 Mute symbol: appears only when
the sound is set to OFF
03 Control Solution flag: appears
when the control solution test
results are saved or displayed
04 Test results
05 Blood insertion symbol :
KetoSens Blood β-Ketone Meter Display Setting Up Your System
Preparation
Press and hold the Sbutton for 3 seconds to enter the SET
mode. After all settings are finished, press and hold the S
button for 3 seconds to turn off the meter.
Press the ◀or ▶button to change values. Press and hold
the ◀or ▶button to scroll faster.
Adjusting the Date and Time
Step 1 Entering SET Mode
Press and hold the Sbutton for
3 seconds to enter SET mode.
After all the segments flash
across the screen, 'SET' will
show up.
Press the ◀or ▶button to
select 'YES' and press the S
button to go to the next step.
Step 2 Setting the Year
Press the ◀or ▶button until the
correct year appears. When the
present year appears, press the S
button to confirm your selection and to
go to the next step.
indicates meter is ready for the application of a drop of
blood or control solution
06 alarm: appears when the time alarm has been set
07 mmol/L: unit for measuring blood glucose
08 KETONE: appears when the KetoSens strip is inserted,
and when the test results are saved or displayed
09 Battery symbol: indicates meter batteries are running low
and need to be replaced
10 Month/Day/Hour/Minute
01 02 03
04
09
0708
05
07
10
06

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Step 3 Setting the Month
A number indicating the month will blink
on the bottom left corner of the screen.
Press the ◀or ▶button until the correct
month appears. Press the Sbutton to
confirm your selection and to go to the
next step.
Step 4 Setting the Date
Press the ◀or ▶button until the screen
displays the correct date. Press the S
button to confirm the date and to go to
the next step.
Step 5 Setting the Time Format
The meter can be set in the AM/PM
12-hour or the 24-hour clock format.
Press the ◀or ▶button to select a
format. The AM•PM symbol is not
displayed in the 24-hour format. After
selecting the format, press the Sbutton to
go to the next step.
Step 6 Setting the Hour
Press the ◀or ▶button until the
correct hour appears.
After the hour is set, press the Sbutton
to go to the next step.
Step 7 Setting the Minute
Press the ◀or ▶button until the
correct minute appears. After setting
the minute, press the Sbutton to go to
the next step.

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Step 8
On pressing the ◀or ▶button the
screen will display 'On' or 'OFF'. Press
the Sbutton to confirm the selection.
The meter will beep in the following
instances if the sound is set to On.
• When you press a button to turn on
the meter
• When the test strip is inserted in the
meter
• When the blood sample is absorbed
into the test strip and the test starts
• When the test result is displayed
• When it is time for a pre-set blood
β-Ketone test
If the sound is set to OFF, none of the sound functions will
work.
After setting the sound, press the Sbutton to go to the next
step.
Setting the Sound On/OFF
Note:
The symbol is displayed only when the sound is set to
OFF.
Step 9
This setting allows you to turn the strip expiration date
indicator on or off. This setting turns the function on or off
only. See page 20 to set the strip expiration date.
When 'EP' appears on the screen, press the ◀or ▶button.
The screen will display 'On' or 'OFF'. Press the Sbutton to
confirm the setting. If you do not want to set the indicator,
press the Sbutton while the screen displays 'OFF'.
Turning on the Strip Expiration Date Indicator
Note:
If the pre-set expiration date is
reached, the meter will display
'EP' when the test strip is
inserted and when the test
result is displayed right after
the test.
If the expiration date is set to
October of 2022, the meter
will display 'EP' at the
beginning of November, 2022.

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Step 2 Setting the Year
A number indicating the year will blink in the left
corner of the screen. Press the ◀or ▶button
until the correct year appears.
Press the Sbutton to confirm the year and set
the month.
Step 3 Setting the Month
A number indicating the month will blink
at the bottom of the screen. Press the ◀or ▶
button until the correct month appears.
Press and hold the S button for 3 seconds to
confirm the month and turn off the meter.
Step 1 Entering the Expiration Date Setting
Press and hold the ◀and ▶buttons at the same time for
3 seconds to enter the expiration date settings. After all
segments flash across the screen, 'EP' will show up.
Note:
The strip expiration date is printed on the test strip box.
Setting the Strip Expiration Date Indicator Checking the System
You may check your meter and test strips using the
KetoSens Control Solutions (level A and B).
The KetoSens Control Solution contains a known
amount of β-Ketone and is used to check that the
meter and the test strips are working properly.
KetoSens Control Solution ranges are printed on the
KetoSens test strip box. Compare the result displayed
on the meter to the KetoSens Control Solution range
printed on the test strip box.
Before using a new meter or a new box of test strips, you should
conduct a control solution test following the procedure on page
22–23 with two different levels of solutions (Control A and B).
Notes:
• Use only the KetoSens Control Solution (available for
purchase separately).
• Check the expiration date 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 solution 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 between 46–86 ˚F (8–30 ˚C).
You may 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 box of test strips,
• If the meter or test strips do not function properly,