BeneCheck BK3-12M-D User manual

Multi-Monitoring Meter
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Check Your Health
Hand in Hand,
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User’s Manual
Total Cholesterol Glucose Uric Acid
General Life Biotechnology Co., Ltd.
5F, No.240, Shinshu Rd., Shin Juang Dist.,
New Taipei City, 242 Taiwan
www.BeneCheck.com.tw
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
TEL : [phone]
FAX : [phone]
E-mail : [email protected]
Doc.#:FIG-312M-C2-101-2 Jan, 2017
BK3-12M-D
Model:BK3-12M-D

Chapter 1 BeneCheck Multi-Monitoring Meter BK3-12M-D
1.1
1.2
1.3
1.4
Chapter 2 Setting the Meter
2.1
2.2
2.3
Chapter 3 How to Perform a Test
3.1
3.2
3.3
Introduction..................................................................................1
Contents of the Kit.............................................................................2
Labelling and Information...................................................................3
BeneCheck Meter Kit..........................................................................4
LCD Screen Display and Alert Tones.....................................................5
Test Strip and Code Strip....................................................................6
Installing/Replacing the Batteries........................................................7
Set the Date and Time.....................................................................7-8
Code the Meter..................................................................................8
Before Testing...................................................................................9
Perform the Test.........................................................................10-12
Alternate Site Testing (AST).......................................................12-14
Care after Testing.......................................................................15-16
3.4
Chapter 4 Meter Memory Function............................................................17-18
Chapter 5 Control Solution Test................................................................19-20
Chapter 7 Care and Maintenance
Chapter 8 Error Message and Trouble Shooting........................................23-24
Chapter 9 Specification.................................................................................25
7.1
7.2
Storing Your Meter...........................................................................22
Cleaning and Caring for Your Meter.....................................................22
Chapter 6 Transmission Function..................................................................21

WARNING :
Chapter 1 BeneCheck Multi-Monitoring Meter BK3-12M-D
1.1 Introduction
Thank you for choosing BeneCheck. BeneCheck Multi-Monitoring Meter BK3-12M-D (meter)
is based on electrochemical biosensor technology, which can check your blood glucose (GLU),
total cholesterol (CHOL), and uric acid (UA) fast and convenient.
Please read this user’s manual carefully before using this product. If you need any further
assistance, please contact your local customer service.
Intended Use:
The meter is used to measure Blood Glucose in fresh capillary whole blood from fingertip,
palm, or forearm, and Total Cholesterol and Uric Acid from fresh fingertip capillary whole
blood. The meter is only for in vitro diagnostic use. The meter can be used by lay persons
at home or patients tested by healthcare professional.
The meter is plasma-calibrated by reference instruments which are traceable to the
following standard reference materials and methods.
Test
Glucose
Total Cholesterol
Uric Acid
Standard
NIST SRM 917c
NIST SRM 911b
NIST SRM 913a
Method
Glucose Oxidase
Abell ⁄Kendall
Uricase ⁄UV
Please carefully read the instructions and test procedures in this user’s manual before using.
Users should consult healthcare professional before making any important medical decision.
Description Quantity
BeneCheck Multi-Monitoring Meter (Model:BK3-12M-D) (with a CR2032 3V battery)
User’s Manual
Quick Guide
Kit Carrying Bag
1
1
1
1
1.2 Contents of the Kit
The items included in BeneCheck Meter Kit:
(please check the meter outer box for exact detail)
Optional : ( not included in the standard kit package, please contact your local distributor for ordering. )
BeneCheck Glucose Test Strip (Model:BK3-G) (with Insert)
BeneCheck Total Cholesterol Test Strip (Model:BK-C2) (with Code Strip and Insert)
BeneCheck Uric Acid Test Strip (Model:BK-U1) (with Code Strip and Insert)
BeneCheck II Glucose Control Solution
BeneCheck II Total Cholesterol Control Solution
BeneCheck Uric Acid Control Solution
Lancing Device
Lancets (pack) (Manufacturer: For detail information, please refer to inside package. )
12

1.4 BeneCheck Meter Kit
Meter ( Front Side & Back Side)
LCD Screen:
Display operating
information and test
results
Right “S” Button:
Confirm and set up
Left “M” Button:
Enter memory mode
Long press to turn off
Ejection Button:
Remove test strip
Test Port:
Insert test strip
Serial Number Sticker
Battery:
3V lithium battery (CR2032)
Please remove the plastic
tab before using
Meter Label:
Information about meter
Battery Lid:
Slide to open.
34
Phone Jack:
No function
1.3 Labelling and Information
Do not reuse
Keep dry
Read instructions
Use by
EU Representative
Manufactured by
Keep away
from sunlight
Caution, consult
accompanying documents
Operation temperature
limitation
Operation
In-vitro diagnostic
Lot number
Storage &
Transportation
4
Storage & Transportation
Condition
CE certification
Serial number
90%
10%
Storage &
Transportation Storage & Transportation
Relative Humidity
90%
10%
Operation
Operation Relative Humidity
Comply with WEEE Directive
2012/19/EU
Date of Manufacture
Ingress Protection

LCD Screen Display:
Information and test result display
Alert Tones: • Normal Alert: a short “beep”
• Warning Alert: 3 short “beeps”
• Turning On/Off: a long “beep”
①
②
③④⑤
⑥
⑦
⑧
⑨⑩⑪
Result Area
Low Battery
Temperature Icon
Average (GLU)
Unit Icon
System Check
①
②
③
④
⑤
⑥
⑦
⑧
⑨
⑩
⑪Code Number Icon
Blood Loading Icon
Strip Loading Icon
Test Mode Icon
Memory Mode Icon
Test Strip:
GLU- Glucose
CHOL- Total Cholesterol
UA- Uric Acid
Code Strip:
The code strip is used to code the meter.
Please do the coding step when you use a new vial of CHOL or UA strip.
Contact Bar :
Insert this end into the
test port of the meter. UA
CHOL
Test Mode
Code
56
7142
Electronic
Contact Bars:
Insert this end into
meter test port.
Sample Inlet:
The whole blood sample and control
solution will be drawn from here.

Installing Instructions:
Chapter 2 Setting the Meter
2.1 Installing/Replacing the Batteries
Please remove the plastic tab under the battery before using. This meter uses a CR2032
battery. Do not use or install different types of battery. It will damage the meter.
1• Slide to remove the
battery lid.
2• Insert the battery with the
positive (+) side up.
3• Slide back the
battery lid.
Note:Dispose the batteries according to your local environmental regulations.
2.2 Set the Date and Time
Press “S” button for over three seconds. You will hear one “beep” for entering the setting
mode, then follow the instruction below to set up.
Setting order: Year/Month/Date/Hour/Minute
• Click “M” button to advance one unit.
• Click “S” button to enter next setting.
• The meter will turn off automatically after setting.
Note:Adjust the correct time and date is important to help managing your health records.
2.3 Code the Meter
Each vial of CHOL or UA strip has a code strip to code your meter. Code your meter when
you first use it or open a new vial of strips. With the Auto Strip Recognition function, once
you code your meter, you do not have to switch the test mode with code card every time
you perform a test.
1• Make sure the meter
is off.
• Then insert the code
strip into the test port.
2• The code number will show on
the screen.Make sure the
numbers on screen, code strip,
and strip vial label are the
same.
• Then remove the code strip.
78
+
CR2032
CHOL
7142
TestStrip
7142
Operation
Storage&
Transportation
Storage&
Transportation
90%
10%
153-229 mg/dL
8.5-12.7 mmol/L
C1303190
2016/01
7142
CHOL 7142

Please follow the instruction carefully to ensure an accurate test result.
Chapter 3 How to Perform a Test
3.1 Before Testing
Materials you need to perform a test:
• BeneCheck Meter
• BeneCheck Test Strip
• Lancing Device/ Lancets
• Tissue or cotton ball with 75% ethanol or disinfection wipes for cleaning the sampling area
before test.
Adjustable AST Tip
(for alternate site
sampling)
3.2 Perform the Test
• Twist and remove the
adjustable tip.
• Insert a lancet into
the holder firmly.
12
• Twist and remove the
protective disk.
• Save the disk for discard use.
• Do not twist the lancet.
• Twist back the tip.
• Adjust skin
penetration depth by
turning the front end.
34
• Take out a test strip and close
the vial immediately, or other
strips will get damp.
• Insert the strip
contact bar into meter
test port.
• The meter will turn on
automatically.
56
• Make sure the code numbers
are the same on screen and
strip vial label in CHOL or UA
test.
• You can start testing after
“ ” appear.
• Pull back the sliding
barrel till it clicks, and
the lancing device is
ready to use.
78
• Hold the lancing device firmly
against sampling site.
• Press the release button.
910
Lancet Holder
Ejection System
Sliding Barrel
Release Button
Depth Indicator/
Adjustable Tip
(for fingertip sampling)
23
Note:Wash your hands with water and soap
thoroughly before and after testing, and
make sure the sampling area is dry before
testing.
Penetration Depth 12 345
Shallow Deep
Beijing Riucheng Medical Supplies Co.,Ltd
Fengxiang Avenue, Fengxiang
Development Zone, Yangsong Town,
Huairou District, Beijing 101400 China
TEL:[phone]
Operation
TestStrip
ControlRange
7142
7142
Note:If “ ” does not appear, remove the
unused strip and repeat step 5.

• Wipe off the first drop
of blood.
• Massage your finger
gently till a round drop
of blood forms.
9• Touch the blood sample with
strip inlet.
• The sample will be drawn
automatically.
• After count down, the result will display on the screen.
• Then eject the used strip into a biohazard waste container.
• The meter will turn off automatically.
11
10
Note:
Make sure you have enough sample for sufficient test.
If the blood smears, please wipe off and squeeze another drop of blood.
Note:Insufficient fill up of blood sample could lead to inaccurate or failed test result.
Note:
• Please code your meter when you first use or open a new vial of strips.
If you have any question, please read Chapter 2.3.
• Please follow the instruction while testing. Improper operation may result in inaccurate
test result or damage the system.
• Please finish the test within 5 minutes or the meter will turn off automatically.
• The meter will not turn on if you insert the wrong end or wrong side of strip.
• Do not use expired strip.
Warning :
●Lancets cannot be reused.
●Please always use certified lancets to ensure safety.
3.3 Alternate Site Testing (AST)
The meter allows you to test glucose from your fingertip, palm or forearm. Blood obtained
from palm and forearm may reduce pain during sampling process, but the glucose level
changes faster in palm and forearm. These differences may cause wrong medical decision.
Note:Please consult healthcare professional before AST sampling.
Suitable timing to acquire blood sample from alternate sites:
• Routinely before meal
• Prior to or two hours after a meal/a short-acting or rapid-acting insulin analogue/exercise.
11 12
Fill up ok Fill up FAILED
Glucose∕Uric Acid∕
Total Cholesterol
0.7 0.8
GLU UA CHOL

DO NOT test from alternate sites:
• During or less then two hours after eating, exercising, or taking medication.
• When you are ill.
• If you think your glucose level is low or you are unaware of your low blood glucose
condition.
• If you are examined for hypoglycemia or hyperglycemia.
• Within two hours after a short-acting or rapid-acting insulin analogues.
• Your AST test result do not match your health condition.
• You are operating machinery or driving a car.
Note:
• Repeat sampling from fingertip if your AST test result do not match your health condition.
• Repeat puncturing the same spot may cause soreness and calluses.
• If it is difficult to sample from alternative site, please sample from fingertip instead.
Palm sampling
Choose an area below your thumb or pinky finger, with
no visible veins and away from deep palm print.
Forearm sampling
Choose an area away from bone, visible veins and hair.
Please massage or warm the site to increase blood flow
in order to get sufficient amount of blood sample.
Lancing and sampling from an alternative site:
1.Repeat the steps1-7 in Chapter 3.2.
(Replace the lacing device tip with adjustable AST tip.)
2.Then press and hold the lancing device against your palm or forearm for
a few seconds, then press the release button.
3.Keep holding the sampling device and tip against your skin.Maintain
pressure until sufficient blood sample formed.
4.Carefully lift the lancing device away. Do not smear the blood sample.
5.Then repeat the steps 10 and 11 in Chapter 3.2.
Note:
• It may need to wait a little longer to get sufficient amount of blood sample from the palm
or forearm. Do not squeeze the site excessively.
• If the blood sample runs or spreads, do not use the sample. Try puncturing again in a
smoother area.
• If you still fail to get enough blood samples at the deepest setting of lancing device, please
try to get lancets in lower gauge.
13 14

3.4 Care after Testing
1.Please follow the instruction to discard used lancets into an appropriate biohazard
container.
• Do not touch the used
lancet, and pierce it
into the protective
lancet cover.
• Discard the used lancet into
biohazard waste container.
• Recap the lancing device
and storage.
2.Record your test result.
3.Store your meter, strips and other items in a cool and dry environment.
(Please check the specification in Chapter 8.)
Special Message
Test Mode Lo Hi
Glucose < 20 mg/dL (1.10 mmol/L) > 600 mg/dL (33.3 mmol/L)
Uric Acid < 3 mg/dL (0.18 mmol/L) > 20 mg/dL (1.19 mmol/L)
Total Cholesterol < 100 mg/dL (2.59 mmol/L) > 400 mg/dL (10.35 mmol/L)
Note:
• Please check your meter performance regularly.
• Dropping, bumping or other violent impact may damage the meter or cause malfunction.
• Do not use the meter in an environment with possible magnetic, electromagnetic, and
radioactive interferences.
• Choking hazard – keep away from children.
Warning :
●Do not disassemble the meter for any reason.
●Do not modify this equipment without authorization of the manufacturer.
●Please follows local regulations to discard used test strips and lancets.
●Used test strips, lancets and any other materials which have been in contact
with blood should be treated as potential biohazards.
●If a user has an infectious disease, the used test strips and other materials
could be sources of infection.
15 16
12
3
生物醫療廢棄物
BIO-MEDICAL
WASTE

Chapter 4 Meter Memory Function
The meter can record 360 results of glucose, 50 results of total cholesterol, and 50 results of
uric acid (include test results and control solution test results). It can also count 7-,14-,21-
and 28-days average for glucose.
The latest test result will replace the oldest when the records exceed maximum memory
capacity. The memories start record from M1 to M360 or M1 to M50.
Directions for Checking Memories: M
M
GLU Average
CHOL or UA Individal Record
GLU Individal Record
17 18
Note:The control results are not included in the average.
GLU control Record
CHOL or UA control Record
1.No test strip in the meter.
2.Press “M” button for 3 seconds till a short “beep” to enter the memory mode.
3.After a full display on screen, press “M” button to switch between GLUC, UA, and CHOL
mode. Press “S” button to select.
4.In GLU memory mode, it will display 7-, 14-, 21-, 28-days average first then individual
record. CHOL and UA memory mode will show individual record directly.
Press “S” button for next test record, and press “M” button for previous record.
5.Once you enter one memory mode, you cannot switch.
Press “M” button for 3 seconds or wait for the meter to turn off. Then repeat step 1-3 to
select another test mode.

Chapter 5 Control Solution Test
Control solution is used to check the performance of the kit. The meter performs adequately
when control test falls within the range listed on test strip vial label.
The meter kit should be check:
• When the meter and strip do not work properly.
• When the test result is unusual or inconsistent.
Control solution range is shown as follow:
Please check your strip vial label for exact range.
Directions: • Insert an unused strip
into the meter.
12
• Shake well and discard
the first three drops of
control solution. And
put one drop onto a
clean surface.
34
• Touch the control solution with
strip sample inlet .
• The result will display
after countdown.
• Compare the result with
the range listed on test
strip vial.
5Note:
• Do not reuse the test strip.
• Newly opened vial of control solution and test
strips must be marked with the opening date.
• Close the strip vial lid completely after use.
• Do not use the meter if the control range do
not fall in the correct range.
• If the control test keeps result wrongly,
please contact an authorized distributor for
help and service.
• Control solutions are not included. Please
contact an authorized distributor for checking
the meter kit performance.
19 20
• Press “M” button for 3 seconds
to enter the control solution
mode.
Test Strip
Operation
Storage&
Transportation
Storage&
Transportation
90%
10%
98-164 mg/dL
5.4-9.1 mmol/L
EA13120901
2017-01
98-164 mg/dL
5.4-9.1 mmol/L
G1303190
2017/01
EA13120901
2017-01
control range level 0/ level 1/ level 2
Operation
Storage&
Transportation
10
Storage&
Transportation
90%
10%
New
Taipei
City
242
MDSS GmbH
Schiffgraben 41
30175 Hannover,
G
FIG-80-SLG10-6B
K
C
ontrol Range
Operation
Storage &
Transportation
Storage &
Transportation
90%
10%
98- 164 mg/dL
5.4-9.1 mmol/L
level 0 / level 1 / level

Chapter 6 Transmission Function
• The meter with Bluetooth 4.0 can apply to IOS, Android 2.3.3 and above.
• The meter complies with IEC 60601-1-2 and the relevant EMC (electromagnetic
compatibility) and RF (radio transmission) requirements regulated by US Federal
Communications Commission. The purpose of these requirements is to ensure that meter
does not affect or being affected by other devices during operation.
• The meter and the transmission function may be interfered while other device is operating
nearby. Ex: mobile phone, wireless internet, etc.
• If the transmission has been interfered. Please keep the meter away from the source of
interference or turn off the interfering device.
• Please make sure the meter and the receiving device are placed within a reasonable
distance (less than five meters) during transmission via Bluetooth.
• Please do not share the meter with other people if you are using Bluetooth transmission
function. The test results from other people will also transmit to the receiving device, and
it will influence your test record.
• The Bluetooth transmission function may not work on certain types of mobile phone due to
the compatibility of Android systems.
Chapter 7 Care and Maintenance
7.1 Storing Your Meter
The meter will be affected by improper storage and handling. Please follow the instructions
and check Chapter 8 for specifications.
• Please avoid bump or other violent behavior, it may caused damage to the meter.
• Do not use this meter in a very dry environment, especially if synthetic materials are
present. It may cause damaging static discharges in a dry environment.
• Do not use the meter near the source of electromagnetic radiation, ex: electrical or
electronically equipment. It may interfere meter operation.
• Do not storage the strips in high humidity environment, or expose directly to the sunlight.
• Do not freeze or refrigerate the meter and strips.
• Keep the meter clean by wiping the exterior appearance with tissues or lin-free cloth.
• Keep your hand dry and clean while handing the strips and performing the test.
• Do not disassemble the meter for any reason.
7.2 Cleaning and Caring for Your Meter
Gently wipe the meter surface with a soft cloth slightly damp with one of the following
cleaning solutions:
• 75% alcohol.
• Super Sani-Cloth disposable wipes.
• Mild dishwashing liquid with water.
• 10% household bleach solution made in the same day. (1 part bleach with 9 part water)
Note:
• Do not allow any wet cloth or liquid to clean your meter.
• Do not allow any liquid run in or around the test port and battery cover.
• Make sure the meter is completely dry before use.
21 22
The meter provides Bluetooth transmission function. It can transmit test results to
connected device wirelessly via Bluetooth.
The screen show "bLE" means Bluetooth transmission function is working.

Chapter 8 Error Message and Trouble Shooting
Message Cause Solution
• The power of the battery
is too low to run a test.
Replace a new battery immediately.
• Problem with code strip.
• Insert the strip in an
improper way.
• Problem with test strip.
Repeat the coding procedure and ensure the code
number is the same in label, code strip and
screen. Insert the strip again. If the problem
persists, please contact the distributor for service.
• Problem with code strip.
• Insert the code strip in
an improper way.
Repeat the coding procedure and ensure the code
number is the same in label, code strip and
screen. If the problem persists, please contact
the distributor for service.
• The temperature was
below or above the
meter operating range.
Repeat the test after the meter has reached to the
temperature within the operating range. If the
problem persists, please contact the distributor
for service.
• An used test strip or a
damp strip.
Review the instructions and try again with a new
test strip.
If the problem persists, please contact the
distributor for service.
23 24
• Problem with strip. Review the instructions and try again with
the same test strip.
If the problem persists, please contact the
distributor for service.
• Uncompleted test caused by
removing the test strip during
the measurement.
Review the instructions and try again with a
new test strip. Please don't remove the strip
before the test is completed.
• Use an improper code
strip.
Repeat the coding procedure and ensure the
code number is the same in label, code strip
and screen. If the problem persists, please
contact the distributor for service.
• Do not get enough
sample volume for the
test.
Take a new strip and make sure you have
enough sample volume for your test. Repeat
the test again. If the problem persists,
please contact the distributor for service.
• Test result is higher than
the range listed on Chapter 9.
1.Review the instructions and try again with
a new test strip.
2.If the problem persists, please call local
authorized distributor for help.
• Test result is lower than
the range listed on Chapter 9.
1.Review the instructions and try again with
a new test strip.
2.If the problem persists, please call local
authorized distributor for help.

25
Chapter 9 Specification
Test Sample
Measuring Time
Measuring Range
Sample Volume
Storage & Transportation
Condition
Operation Temperature
Storage & Transportation
Relative Humidity
Memory
Battery Type
Battery Life
Dimensions
Weight
Altitude
Expected Service Life
Transmission Function
Fresh Capillary Whole Blood
GLU:5 seconds; CHOL: 26 seconds; UA: 15 seconds
GLU: 20-600 mg/dL (1.1 - 33.3 mmol/L);
CHOL: 100 - 400 mg/dL ( 2.59 - 10.35 mmol/L );
UA :3 - 20 mg/dL ( 0.18 - 1.19 mmol/L )
GLU: 0.7 μL; CHOL: 0.8 μL; UA: 1 μL
4 - 30˚C (39-86˚F)
10 - 40˚C (50-104˚F)
10-90%
460 Test Results (GLU: 360 ; CHOL: 50 ; UA: 50)
One 3V (CR2032) lithium battery
Approximately 1,000 tests
88*52*16 mm
About 50g (with battery)
10,000 feet (3048 m)
5 years
Bluetooth 4.0
Note:
• Please refer to the strip insert for accuracy, precision, limitation, and other important
information.
Electromagnetic Compatibility
This meter meets the electrostatic discharge immunity testing was basic standard
IEC6100-4-2. In addition, the meter meets the electromagnetic emissions requirements as
per EN61326. The purpose of these requirements is to ensure that meter does not affect or
being affected by other devices during operation.
Warning :
●Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally. The BeneCheck Multi-Monitoring Meter may provide a
description or list of equipment with which the BeneCheck Multi-Monitoring
Meter has been tested in a stacked or adjacent configuration.
●Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
●Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the BeneCheck Multi-Monitoring Meter, including cables specified
by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.

FCC Statement:
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may
cause undesired operation.
NOTE:
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
●Reorient or relocate the receiving antenna.
●Increase the separation between the equipment and receiver.
●Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
●Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.