Human HumaSens User manual

Headline
HumaSens
Glucose Meter
User Manual

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Table of Contents
Chapter 1 HumaSens Glucose Meter 3
1.1 Introduction 3
1.2Contents of the Kit 3
1.3Symbols 4
1.4System Components 5
Chapter 2 Meter Setup 6
2.1Replacing the Battery 6
2.2Set Date, Time and Units 6
2.3Coding the Meter 8
2.4Control Test 9
Chapter 3 Performing a Test 11
3.1Before Testing 11
3.2Test Procedures for Blood Glucose 13
3.3Safety Instructions 14
Chapter 4 Meter Memory Function 14
Chapter 5 Storage and Handling 15
Chapter 6 Icons and Alert Tones 16
6.1 Screen Icons 16
6.2 Alert Tones 16
Chapter 7 Error Messages and Troubleshooting 17
Chapter 8 Specifications 18
Chapter 9 Limitations of Blood Glucose Tests 19

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1.1 Introduction
The HumaSens Glucose Meter by HUMAN provides you
with accurate, plasma-calibrated results based on elec-
trochemical sensor technology. This system measures
blood glucose levels precisely and displays results within
10 seconds.
Intended Use:
The HumaSens Glucose Meter is designed to measure
the blood glucose levels in whole blood and must only
be used with HumaSens Glucose test strips. The test
strips are for self-testing outside the body (in vitro
diagnostic use). The system is also suitable for use by
healthcare professionals. It should be used only for
testing glucose with fresh capillary blood samples taken
from a fingertip.
The HumaSens Glucose test strips are calibrated against
the Kodak EKTACHEM DT60 analyzer using venous
plasma. Calibration can be referenced to the NIST SRM
917b standard.
Please read the entire user manual carefully before
using the HumaSens Glucose Meter to test your blood
glucose level. This user manual guides you through the
operating procedures with illustrated directions and
helps you find the required information.
1.2 Contents of the Kit
Please check the HumaSens Glucose Meter package for
the following items:
Description Qty.
HumaSens Glucose Meter 1
HumaSens Glucose test strips (10 pcs/vial)
Code Strip (glucose) 1
Chapter 1 HumaSens Glucose Meter

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Headline
HumaSens Glucose control solution (4 ml)
HumaSens user manual 1
HumaSens quick guide 1
Lithium battery 3V (CR2032) 1
Pouch 1
Lancets (10 pcs/bag)
Lancing device 1
Lancing device user instructions 1
Glucose test strip user instructions 1
Glucose control solution user instructions 1
Patient diary 1
Optional: (not included in the standard kit package,
please contact your authorized distributor for ordering.)
[REF]
HumaSensGlucose test strips (2x25strips/box) 17542/25
Lancets (100 pcs) 17543
HumaSens Glucose control solution (2x4 ml) 17545
PC connector cable 17549
PC software 17550
Battery pack 17548
1.3 Symbols
EC
representative
Catalogue
number
In vitro
diagnostic
device
Lot number
[EC¤REP]
[REF]
[IVD]
[LOT]
Do not re-use
Keep dry
Storage temperature
Product conforms to
directive 98/79/EC
Manufacturer
Expiry date
Consult manual
Attention
Recap immediately
after use
Use within 3 months
after initial opening
½
¼
Š
Chapter 1 HumaSens Glucose Meter

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1.4 System Components
Glucose Meter (Front View) Glucose Meter (Back View)
Glucose test strip
Code strip
M button
Strip port
Set button
Screen
Battery cover
Type plate
PC connection
port
Electrodes
Sample entry zone
Electrodes
Code number

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Before first use, remove the transparent
protective foil from the battery.
2.1 Replacing the Battery
The battery is located inside the meter.
Use only 3V lithium batteries (CR2032).
Do not use with different types of
batteries, as this may damage the
electronics of the meter.
Instructions
1. Remove the back cover by pulling it to
the side.
2. Insert a new battery into the battery
socket with the “+” side facing up.
3. Replace the battery cover.
2.2 Set Date, Time and Units
The setup has to be completed before
first use or after a battery change. Press
and hold the “Set” button for at least
two seconds. The meter will beep once
and enter the setup mode.
In setup mode, the LCD screen of the
meter shows all setting options conse-
cutively, starting with a flashing year
number:
1. Set the Year
A. When the meter enters setup mode,
the year will flash on the screen.
B. Click the “M” button to advance in
one-year increments to set the correct
year.
C. After setting the desired year, click
the “Set” button again, and the meter
advances to the month setting.
2. Set the Month
A. Click the “M” button until the correct
month appears.
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2
3
Chapter 2 Meter Setup

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B. Click the “Set” button, and the day segment starts
flashing.
3. Set the Day
A. Click “M” button until the correct day appears.
B. Click the “Set” button, and the hour segment will
start flashing.
4. Set the Hour
A. Click “M” button until the correct hour appears.
B. Click the “Set” button, and the minute segment will
start flashing.
5. Set the Minute
A. Click the “M” button until the correct minute appears.
B. Click the “Set” button, and the measurement unit
segment starts flashing.
6. Set the Measurements Units
A. A flashing “mg/dl” will display on the screen.
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6 A
6 B

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B. Pressing the “M” button will switch
the unit of measure between “mg/dl”
and “mmol/l”. Click the “Set” button and
the meter advances to patient condition
index setting.
7. Enable/Disable the Patient Condition
Index
A. A flashing “C.OFF” or “C. ON” will
appear on the screen. This indicates
whether entering the patient condition
index during measurement mode is
disabled or enabled.
B. Click the “M” button to switch between
disabled and enabled. After the meter
settings are complete, press the “Set”
button. “OFF” will be displayed on the
screen and the instrument will shut
down.
Note:
Before each test, please make sure the
preferred unit of measurement is set.
Make sure that the sequence of setup is
completed, or the settings will not be
stored.
2.3 Coding the Meter
The HumaSens Glucose Meter must be
coded before testing with HumaSens test
strips for the first time, or every time a
new lot of glucose test strips is used.
Each vial of glucose test strips has an
assigned code number. The code strip is
packaged with the test strips and used to
code the meter.
7 A
7 B
Chapter 2 Meter Setup

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Procedure:
1. Make sure that the code number on
the code strip is the same as on the
glucose test strip vial.
2. Insert a code strip into the test port
of the meter. A code number will appear
on the screen.
3. Make sure the code number on the
screen is the same as the code number
on the code strip and on the test strip
vial. Remove the code strip. “ ” should
appear on the screen, indicating that the
meter has been successfully coded to the
respective test strip lot.
Caution:
If “E-E” appears on the screen during
the coding procedure, there may be a
problem with the code strip or a wrong
category code strip is being used. Check
that the correct strip type is being used.
Perform the coding procedure again,
using a different code strip if necessary.
If “E-E” continues to appear, please
contact your authorized distributor for
service.
2.4 Control Test
The purpose of HumaSens Glucose
control solution is to check the perfor-
mance of the HumaSens Glucose Meter.
The system is performing correctly if the
control test result falls within the indica-
ted control range listed on the test strip
vial. Only use HumaSens Glucose control
solution ( [REF] 17545).
0123
0123
M S
0123
UA 0123
Chol 0123
1
0123
0123
M S
0123
UA 0123
Chol 0123
2
0123
0123
M S
0123
UA 0123
Chol 0123
3

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M S
M S
M SM S
M SM S
M S
MS
M SM S
1
M SM S
M S
M S
M SM S
M S
MS
M SM S
M SM S
M SM S
M S
M S
M S
MS
M SM S
2
3
A control should be performed:
>If the meter is being used for the first
time or a new lot of test strips is being
used (indicated by a different code
number).
>If you suspect that the meter or test
strips are not working properly.
>Any time you see repeated unexpected
blood glucose test results.
>Any time you drop or bump the meter.
>You should check system performance
with the HumaSens Glucose control so-
lution regularly or anytime you suspect
that test results are inaccurate.
1. Insert a test strip into test port. The
meter will switch on automatically.
2. The code number will appear on the
screen. Make sure the code number is
the same as the one on the test strip vial.
3. A blood drop symbol flashing on the
screen means the system is ready for
sample loading.
4. Shake the control solution vial well,
then open the cap and discard the
first three drops. After cleaning the
dispensing tip with a tissue, drop some
control solution onto a clean, non-
absorbent surface.
5. Bring the sample inlet of the test strip
in contact with the drop of control
solution until the meter beeps. The
screen will display a countdown from
10 seconds.
6. After counting down, the screen will
display the control solution test result.
Compare the test results to the control
range shown on the test strip vial.
Chapter 2 Meter Setup

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Chapter 2 Meter Setup Chapter 3 Performing a Test
Note:
>Please read this user manual and the
package insert for HumaSens control
solution before use.
>The vial should be shaken well before
use.
>Mark the freshly opened vials of
control solution and test strips with the
opening date.
>If the test results are outside the con-
trol range, repeat the test. If the result
is still out of range, please contact your
authorized distributor for service. Do
not continue to use the meter for blood
glucose measurement.
>Do not reuse the test strips and always
close the cap of the test strip vial tightly
after use.
3.1 Before Testing
Please follow these step-by-step instruc-
tions to ensure accurate test results.
Materials required to perform a blood
glucose test include:
>HumaSens Glucose Meter
>HumaSens Glucose test strip
>Lancing device
>Lancet
>Soap and water for thorough skin
cleaning.
Procedure:
Load the lancing device with a lancet
and adjust the desired penetration depth
according to the lancing device manual.
Clean your hands as described.
M SM S
M SM S
M SM S
M S
M S
M SM S
4
M SM S
M SM S
M SM S
M S
MS
M SM S
M SM S
M SM S
M SM S
M S
MS
M S
M S
5
6

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1. Take a test strip from the vial. Imme-
diately recap the vial to keep the strips dry.
2. Fully insert the electrode end of the
test strip (label side facing upwards) into
the strip port of the meter. The meter
will switch on automatically and the
code number appears on the screen.
3. Make sure the code number on the
screen is the same as the one on the test
strip vial. If it is not, remove the test
strip. Recoding the meter is necessary
(described in section 2.3.)
4. If the patient condition index has been
enabled during setup, one of the
following indices will appear on the
screen: “BEF” (before meal), “AF T ” (after
meal), or “AC T” (after activity). Pressing
the “M” button will alternate between
these indices (see illustrations on the
following page).
Note:
>A measurement must be performed
within 3 minutes, otherwise the meter
switches off automatically. Remove and
reinsert the test strip for measurement.
>Do not reuse test strips. Error message
“E-U” will be displayed on the screen if a
used test strip is inserted.
>If the wrong end of the test strip is
inserted, or if the test strip is inserted
upside down, the meter will not be
activated.
>Lancets must not be reused.
>Always use a lancet supplied by
HUMAN to ensure safety.
Š The lancing device must not
be shared by multiple users.
M S
M S
M S
M S
M S
M S
M SM S
3
2
M S
M S
M SM S
1
Chapter 3 Performing a Test

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3.2 Test Procedure for Blood Glucose
1. After choosing the appropriate index,
press the “Set” button to enable loading
the blood sample. Take a blood sample
according to the instructions for the
lancing device.
2. Touch the drop of blood on your finger-
tip with the sample entry zone of the strip
until the meter beeps, indicating the sample
has been drawn into the strip successfully.
3. The meter will count down from
10 seconds. After 10 seconds the blood
glucose concentration will be displayed
on the screen.
Note:
>After lancing, make sure to wipe off the
first drop of blood to avoid contamination
with other body fluids.
>Use the strips before the expiry date
and within 3 months after the first
opening of the vial.
>Apply the blood sample to the correct
position on the test strip.
M S
M S
M S
M S
M SM S
M SM S
1
“M” button
“M” button
“M” button
M S
M S
M S
M S
M SM S
M SM S
2
M S
M S
M S
M S
M S
M S
M SM S
3

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Special Messages:
Messages Glucose result
Lo < 20 mg/dl (1.11 mmol/l)
Hi > 600 mg/dl (33.3 mmol/l)
>Low or high blood glucose readings may indicate a po-
tentially serious health condition. If your blood glucose
reading is unusually low or high, or you do not feel the
way your reading indicates, repeat the test with a new
test strip. If your reading is not consistent with your
symptoms, please contact a healthcare professional.
3.3 Safety Instructions
1. Improper handling of the meter, such as dropping, bum-
ping or other violent impact may damage the meter.
2. Please keep the meter away from interference from
magnetic fields, electromagnetic and radioactive radiation.
Warning:
>Do not disassemble the meter. This will nullify the
warranty.
>Please follow local regulations when discarding used
test strips, batteries and lancets.
>Used test strips, lancets and any other materials that
have come in contact with blood should be treated as
potential biohazards.
The HumaSens Glucose Meter automatically stores up to
360 blood glucose results or control test results. It also
provides you with 7-, 14-, 21- and 28-day averages of the
blood glucose test results. The memory counts up from
M01 through M360 for glucose tests. Stored results are
unaffected by low battery power or a battery change.
Memory Recall Procedure:
1. Make sure that no test strip is inserted in the meter.
Chapter 4 Meter Memory Function
Chapter 3 Performing a Test

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2. Press the “M” button once to switch on the meter.
After a short “beep” a full display will appear on screen,
and the meter enters standby mode.
3. Press the “M” button once again and the meter will
switch to memory mode. The 7-day average (7 DAY.A)
will be displayed on the screen.
4. Repeated pressing of the “M” button will switch to the
14, 21 and 28-day averages.
5. After the 28-day average, the stored results appear
on the screen, starting with M01. The memory number
increases by one each time the button is pressed until
M360 is reached.
6. Press the “Set” button for over 3 seconds and the meter
will switch off after a long “beep”. The meter will also auto-
matically shut down after max. 3 minutes without any input.
Note:
>If 360 test results are already stored and a new one
is added, the oldest test result is automatically over-
written. The latest result will be recorded as M01.
The performance of test strips may be affected by im-
proper storage and handling. Please store the test strips
and meter carefully according to the specifications listed
in Chapter 8.
Note:
1. Store the meter, code strip, test strips and control
solution at 10…30°C.
2. Do not store test strips in a high humidity environ-
ment or expose them to direct sunlight.
3. Do not freeze or refrigerate the meter or strips.
4. Keep the meter clean by wiping the exterior with a
tissue or a lint-free cloth.
5. Handle the strip with clean, dry hands; the skin penetra-
tion site for the blood sample should be cleaned and dried
thoroughly.
Chapter 5 Storage & Handling
Chapter 4 Meter Memory Function

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6.1 Screen Icons
Information is displayed on the screen
by means of easy-to-understand icons.
6.2 Alert Tones
>Normal Alert Sound: short “beep”
>Warning Alert Sound: 5 short “beeps”
>Switching On/Off Alert Sound: long “beep”
Test strip symbol
Blood drop symbol
Coding successful
Coding in process
Battery symbol
Test result/code no.
Temperature range
Memory retrieval
Test mode
TimeDate
Averaging mode Measurement units
Chapter 6 Icons and Alert Tones

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Message
E-0
E-b
Err. 3
E-E
E-t & Temperature
Icon
E-U
E-9
E-A
E-I
*
Cause
Possible problem with the test strip or code
strip.
Low battery power.
Reference voltage or circuit error.
1. Possible problem with meter self-check.
2. Use of wrong or damaged code strip or the
code strip was inserted improperly.
The temperature is outside the system
operating range.
Indicates a used test strip or a temporary or
permanent electronic problem.
The test strip was removed prematurely.
Meter software problem.
Non-authorized code strip.
No display.
Solution
Repeat the test with a new test strip. If the problem
persists, please contact your authorized distributor
for service.
Replace the battery at once.
Call your authorized distributor for assistance.
Switch off then retry. If the error appears again,
contact your authorized distributor for service.
Check that the code number on the meter display
matches the code number on the test strip vial.
Code the meter and retest, using a new code strip
and test strip lot, if necessary. If the error message
appears again, please contact your authorized
distributor for service.
Repeat the test after the meter and the test strip
have reached a temperature within the operating
range.
Repeat the test with a new test strip. If the error
message appears again, please contact your
authorized distributor for service.
Do not remove the test strip until the measurement
is completed.
Please contact your authorized distributor for
assistance.
Only use HUMAN code strips.
Remove the transparent protective foil from the
battery.
Chapter 7 Error Messages and Troubleshooting

18
System Accuracy: ± 20% at glucose level ≥75 mg/dl (4.17 mmol/l)
± 15 mg/dl (0.83 mmol/l) at glucose level < 75 mg/dl (4.17 mmol/l)
Principle: Electrochemical biosensor
Calibration: Plasma-equivalent
Test Sample: Fresh capillary whole blood
Measuring Time: 10 seconds
Measuring Range: 20 – 600 mg/dl
(1.1 – 33.3 mmol/l)
Sample Volume: Min. 1 µl
Hematocrit Range: 30 – 55%
Strip Storage Temperature: 10...30°C (50...86°F)
Operation Temperature: 10...40°C (50...104°F)
Relative Humidity: Less than 95%
Memory: 360 test results
Battery Type: One 3V (CR2032) lithium battery
Battery Life: Approximately 1000 tests
Dimensions: 86x57x17 mm (LxWxH)
Weight: Approx. 48 g (incl. battery)
Altitude Range: Up to 10000 feet/3250 m
Chapter 8 Specifications

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Latest information on test limitations can be found in
the package insert of the Glucose test strips.
Additional Information for Healthcare Professionals:
>In a clinical setting, when venous whole blood is used
for the test, it can be collected into heparin-containing
test tubes within 30 minutes after drawing. The results
may be as much as 7% lower than a capillary sample.
Since the glucose test strips are plasma calibrated to be
used for whole blood, testing with serum or plasma will
give falsely high results.
>Samples from patients undergoing oxygen therapy
may yield falsely low results.
>In conditions of decreased peripheral blood flow
(examples would include but are not limited to severe
dehydration, shock, or a hyperosmolar state [with or
without ketosis] and hypertension) the test results
may be falsely low.
>Lipemic samples: Cholesterol levels up to 500 mg/dl
(12.94 mmol/l) do not affect the results. Grossly lipemic
patient samples have not been tested and are not
recommended for testing with HumaSens Glucose
test strips.
Chapter 9 Limitations of Blood Glucose Tests

Product no. 17540001 / Revision date 04/2011-12
HUMAN
Gesellschaft für Biochemica
und Diagnostica mbH
Max-Planck-Ring 21
65205 Wiesbaden · Germany
Tel. +49 6122-9988-0
Fax +49 6122-9988-100
e-mail: [email protected]
www.human.de
0483
[IVD]
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