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User’s Manual
General Life Biotechnology Co., Ltd. MDSS GmbH
5F, No.240, Shinshu Rd., Shin Juang Dist., Schiffgraben 41
New Taipei City, 242 Taiwan 30175 Hannover, Germany
www.BeneCheck.com.tw
Model:BK3-12M-D

TEL : +886-2-22053698
FAX : +886-2-22080779
E-mail : [email protected]
d,
Doc.#:FIG-312M-C2-101-2 Jan, 2017
Hand in HanHealth
Y o u r
Check
Total Cholesterol Glucose Uric Acid BK3-12M-D
Chapter 1 BeneCheck Multi-Monitoring Meter BK3-12M-D
1.1 Introduction..................................................................................1
1.2 Contents of the Kit.............................................................................2
1.3 Labelling and Information...................................................................3
1.4 BeneCheck Meter Kit..........................................................................4
LCD Screen Display and Alert Tones.....................................................5
Test Strip and Code Strip....................................................................6
Chapter 2 Setting the Meter
2.1 Installing/Replacing the Batteries........................................................7
2.2 Set the Date and Time.....................................................................7-8
2.3 Code the Meter..................................................................................8
Chapter 3 How to Perform a Test
3.1 Before Testing...................................................................................9
3.2 Perform the Test.........................................................................10-12
3.3 Alternate Site Testing (AST).......................................................12-14
3.4 Care after Testing.......................................................................15-16
Chapter 4 Meter Memory Function............................................................17-18
Chapter 5 Control Solution Test................................................................19-20
Chapter 6 Transmission Function..................................................................21
Chapter 7 Care and Maintenance
7.1 Storing Your Meter...........................................................................22
7.2 Cleaning and Caring for Your Meter.....................................................22
Chapter 8 Error Message and Trouble Shooting........................................23-24
Chapter 9 Specification.................................................................................25
Chapter 1 BeneCheck Multi-Monitoring Meter BK3-12M-D 1.2 Contents of the Kit
1.1 Introduction The items included in BeneCheck Meter Kit:
Thank you for choosing BeneCheck. BeneCheck Multi-Monitoring Meter BK3-12M-D (meter) (please check the meter outer box for exact detail)
is based on electrochemical biosensor technology, which can check your blood glucose (GLU), Description Quantity
total cholesterol (CHOL), and uric acid (UA) fast and convenient. BeneCheck Multi-Monitoring Meter (Model:BK3-12M-D) (with a CR2032 3V battery) 1
Please read this user’s manual carefully before using this product. If you need any further User’s Manual 1
assistance, please contact your local customer service. Quick Guide 1
Kit Carrying Bag 1
Intended Use:
The meter is used to measure Blood Glucose in fresh capillary whole blood from fingertip, Optional : ( not included in the standard kit package, please contact your local distributor for ordering. )
palm, or forearm, and Total Cholesterol and Uric Acid from fresh fingertip capillary whole BeneCheck Glucose Test Strip (Model:BK3-G) (with Insert)
blood. The meter is only for in vitro diagnostic use. The meter can be used by lay persons BeneCheck Total Cholesterol Test Strip (Model:BK-C2) (with Code Strip and Insert)
at home or patients tested by healthcare professional. BeneCheck Uric Acid Test Strip (Model:BK-U1) (with Code Strip and Insert)
BeneCheck II Glucose Control Solution
The meter is plasma-calibrated by reference instruments which are traceable to the BeneCheck II Total Cholesterol Control Solution
following standard reference materials and methods. BeneCheck Uric Acid Control Solution
Test Standard Method Lancing Device
Glucose NIST SRM 917c Glucose Oxidase Lancets (pack)　(Manufacturer: For detail information, please refer to inside package. )
Total Cholesterol NIST SRM 911b Abell ⁄ Kendall
Uric Acid NIST SRM 913a Uricase ⁄ UV

WARNING :
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.
1 2
1.3 Labelling and Information 1.4 BeneCheck Meter Kit
Meter ( Front Side & Back Side)
Use by In-vitro diagnostic

Lot number LCD Screen: Serial Number Sticker

Manufactured by Display operating
information and test
Date of Manufacture
Do not reuse results Battery:
3V lithium battery (CR2032)
Serial number
Please remove the plastic
Keep dry Right “S” Button:
Operation tab before using
Operation temperature Confirm and set up
Keep away limitation
from sunlight
Operation Left “M” Button:
90%
Enter memory mode
Read instructions Operation Relative Humidity
Long press to turn off
10%
Battery Lid:
Caution, consult Storage &
Slide to open.
Transportation
accompanying documents Storage & Transportation Ejection Button:
Condition Remove test strip
EU Representative 4

Storage &
Transportation
Comply with WEEE Directive 90% Storage & Transportation Test Port: Meter Label:
2012/19/EU Relative Humidity Insert test strip Information about meter
Phone Jack:
10%
No function
Ingress Protection CE certification
3 4
LCD Screen Display: Test Strip:
Information and test result display GLU- Glucose
CHOL- Total Cholesterol
Result Area UA- Uric Acid
①
⑪ ⑩ ⑨ ② Low Battery
Electronic
③ Temperature Icon Sample Inlet:
Contact Bars:
Average (GLU) Insert this end into The whole blood sample and control
④ solution will be drawn from here.
⑧ meter test port.
⑤ Unit Icon
①
⑥ System Check
⑦ Code Strip:
⑦ Blood Loading Icon The code strip is used to code the meter.
② ⑥
⑧ Strip Loading Icon Please do the coding step when you use a new vial of CHOL or UA strip.

⑨ Test Mode Icon

③ ④⑤ Contact Bar :
CHOL 7142
⑩ Memory Mode Icon
Insert this end into the Code
⑪ Code Number Icon test port of the meter.
UA

Test Mode
Alert Tones: • Normal Alert: a short “beep”
• Warning Alert: 3 short “beeps”
• Turning On/Off: a long “beep”
5 6
Chapter 2 Setting the Meter Setting order: Year/Month/Date/Hour/Minute
2.1 Installing/Replacing the Batteries • Click “M” button to advance one unit.
• Click “S” button to enter next setting.
Please remove the plastic tab under the battery before using. This meter uses a CR2032
• The meter will turn off automatically after setting.
battery. Do not use or install different types of battery. It will damage the meter.
Installing Instructions:
1 • Slide to remove the 2 • Insert the battery with the
　battery lid. 　positive (+) side up.
+
CR2032

Note:Adjust the correct time and date is important to help managing your health records.

2.3 Code the Meter

3 • Slide back the Each vial of CHOL or UA strip has a code strip to code your meter. Code your meter when
　battery lid. 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 2 • The code number will show on
Note:Dispose the batteries according to your local environmental regulations. 　is off. 7142 　the screen.Make sure the
• Then insert the code 　numbers on screen, code strip,
　strip into the test port. 　and strip vial label are the
2.2 Set the Date and Time
　same.
C1303190
Test Strip 2016/01

7142

Press “S” button for over three seconds. You will hear one “beep” for entering the setting

CHOL7142
CH
O 153-229 mg/dL

L 8.5-12.7 mmol/L

• Then remove the code strip.

71 Storage & Storage &
Operation Transportation Transportation
90%

42 10%

mode, then follow the instruction below to set up.

7 8
Chapter 3 How to Perform a Test 3.2 Perform the Test
Please follow the instruction carefully to ensure an accurate test result. 1 • Twist and remove the 2 • Twist and remove the
　adjustable tip. 　protective disk.
3.1 Before Testing • Insert a lancet into • Save the disk for discard use.
　the holder firmly. • Do not twist the lancet.
Materials you need to perform a test:
• BeneCheck Meter
• BeneCheck Test Strip
• Lancing Device/ Lancets 3 • Twist back the tip. 4 • Take out a test strip and close
• Tissue or cotton ball with 75% ethanol or disinfection wipes for cleaning the sampling area • Adjust skin 　the vial immediately, or other
before test. 　penetration depth by Test Strip

7142 　strips will get damp.

Lancet Holder
Control Range

　turning the front end.

Operation

Ejection System
Depth Indicator/
5 • Insert the strip 6 • Make sure the code numbers
3

Adjustable Tip
Sliding Barrel 　contact bar into meter 　are the same on screen and
2

(for fingertip sampling)

　test port. 　strip vial label in CHOL or UA
Adjustable AST Tip • The meter will turn on 　test.
Release Button
7142

(for alternate site 　automatically. • You can start testing after

sampling) 　“　 ” appear.
Note:If “ ” does not appear, remove the
Penetration Depth Shallow Deep unused strip and repeat step 5.
1 2 3 4 5
7 • Pull back the sliding 8 • Hold the lancing device firmly
　barrel till it clicks, and 　against sampling site.
Note:Wash your hands with water and soap Beijing Riucheng Medical Supplies Co.,Ltd
Fengxiang Avenue, Fengxiang 　the lancing device is • Press the release button.
thoroughly before and after testing, and
Development Zone, Yangsong Town, 　ready to use.
make sure the sampling area is dry before
Huairou District, Beijing 101400 China
testing. TEL:+86-10-61678701
9 10
 9 • Wipe off the first drop 10 • Touch the blood sample with Note:
　of blood. 　strip inlet. • Please code your meter when you first use or open a new vial of strips.
• Massage your finger • The sample will be drawn 　If you have any question, please read Chapter 2.3.
　gently till a round drop 　automatically. • Please follow the instruction while testing. Improper operation may result in inaccurate
　of blood forms. 　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.
Note:
• Do not use expired strip.
Make sure you have enough sample for sufficient test.
If the blood smears, please wipe off and squeeze another drop of blood.
Warning :
● Lancets cannot be reused.
0.7 0.8 Glucose／Uric Acid／ ● Please always use certified lancets to ensure safety.
Total Cholesterol
Fill up ok Fill up FAILED

GLU UA CHOL 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
Note:Insufficient fill up of blood sample could lead to inaccurate or failed test result.
changes faster in palm and forearm. These differences may cause wrong medical decision.

11 • After count down, the result will display on the screen.

• Then eject the used strip into a biohazard waste container. Note:Please consult healthcare professional before AST sampling.
• The meter will turn off automatically.
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
DO NOT test from alternate sites: Lancing and sampling from an alternative site:
• During or less then two hours after eating, exercising, or taking medication. 1.Repeat the steps1-7 in Chapter 3.2.
• When you are ill. (Replace the lacing device tip with adjustable AST tip.)
• If you think your glucose level is low or you are unaware of your low blood glucose 2.Then press and hold the lancing device against your palm or forearm for
　condition. a few seconds, then press the release button.
• If you are examined for hypoglycemia or hyperglycemia. 3.Keep holding the sampling device and tip against your skin.Maintain
• Within two hours after a short-acting or rapid-acting insulin analogues. pressure until sufficient blood sample formed.
• Your AST test result do not match your health condition. 4.Carefully lift the lancing device away. Do not smear the blood sample.
• You are operating machinery or driving a car. 5.Then repeat the steps 10 and 11 in Chapter 3.2.

Note:
• Repeat sampling from fingertip if your AST test result do not match your health condition. Note:
• Repeat puncturing the same spot may cause soreness and calluses. • It may need to wait a little longer to get sufficient amount of blood sample from the palm
• If it is difficult to sample from alternative site, please sample from fingertip instead. 　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
Palm sampling 　smoother area.
Choose an area below your thumb or pinky finger, with • If you still fail to get enough blood samples at the deepest setting of lancing device, please
no visible veins and away from deep palm print. 　try to get lancets in lower gauge.

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.
13 14
3.4 Care after Testing Note:
1.Please follow the instruction to discard used lancets into an appropriate biohazard • Please check your meter performance regularly.
container. • Dropping, bumping or other violent impact may damage the meter or cause malfunction.
• Do not touch the used 2 • Do not use the meter in an environment with possible magnetic, electromagnetic, and
1 • Discard the used lancet into
　lancet, and pierce it 　radioactive interferences.
　biohazard waste container.
　into the protective • Choking hazard – keep away from children.
　lancet cover.
生物醫療廢棄物
Warning :
● Do not disassemble the meter for any reason.
DICAL
BIO-ME
WASTE

3 • Recap the lancing device ● Do not modify this equipment without authorization of the manufacturer.
　and storage. ● 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.
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)
15 16
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:
1.No test strip in the meter. M GLU Average GLU Individal Record
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. GLU control 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. M

CHOL or UA Individal Record

Note:The control results are not included in the average.

17 CHOL or UA control Record 18
Chapter 5 Control Solution Test Directions:
1 • Insert an unused strip 2 • Press “M” button for 3 seconds
Control solution is used to check the performance of the kit. The meter performs adequately
　into the meter. 　to enter the control solution
when control test falls within the range listed on test strip vial label.
　mode.
The meter kit should be check:
• When the meter and strip do not work properly.
• When the test result is unusual or inconsistent.
3 • Shake well and discard 4 • Touch the control solution with
Control solution range is shown as follow:
　the first three drops of 　strip sample inlet .
Please check your strip vial label for exact range.
　control solution. And
　put one drop onto a
　clean surface.
control range level 0/ level 1/ level 2
G1303190

• The result will display Note:

Test Strip 2017/01

98-164 mg/dL 5
98-164 mg/dL
　after countdown. • Do not reuse the test strip.
5.4-9.1 mmol/L
5.4-9.1 mmol/L
Storage & Storage &

• Compare the result with • Newly opened vial of control solution and test
Operation Transportation Transportation
90%

10%

　the range listed on test 　strips must be marked with the opening date.
　strip vial. • Close the strip vial lid completely after use.
• Do not use the meter if the control range do
New Taipei City 242
MDSS GmbH
Schiffgraben 41
　not fall in the correct range.
EA13120901 • If the control test keeps result wrongly,
30175 Hannover, G
FIG-80-SLG10-6BK

EA13120901
Control Range level 0 / level 1 / level

　please contact an authorized distributor for

2017-01

2017-01 98- 164

5.4-9.1
mg/dL
mmol/L
Storage & Storage &
Operation Transportation Transportation
90% 　help and service.
• Control solutions are not included. Please
Storage & Storage &
Operation Transportation Transportation
90% 10%
10 10%

　contact an authorized distributor for checking

　the meter kit performance.
19 20
Chapter 6 Transmission Function Chapter 7 Care and Maintenance
The meter provides Bluetooth transmission function. It can transmit test results to 7.1 Storing Your Meter
connected device wirelessly via Bluetooth. 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
The screen show "bLE" means Bluetooth transmission function is working. 　electronically equipment. It may interfere meter operation.
• The meter with Bluetooth 4.0 can apply to IOS, Android 2.3.3 and above. • Do not storage the strips in high humidity environment, or expose directly to the sunlight.
• The meter complies with IEC 60601-1-2 and the relevant EMC (electromagnetic • Do not freeze or refrigerate the meter and strips.
compatibility) and RF (radio transmission) requirements regulated by US Federal • Keep the meter clean by wiping the exterior appearance with tissues or lin-free cloth.
Communications Commission. The purpose of these requirements is to ensure that meter • Keep your hand dry and clean while handing the strips and performing the test.
does not affect or being affected by other devices during operation. • Do not disassemble the meter for any reason.
• The meter and the transmission function may be interfered while other device is operating
nearby. Ex: mobile phone, wireless internet, etc. 7.2 Cleaning and Caring for Your Meter
• If the transmission has been interfered. Please keep the meter away from the source of Gently wipe the meter surface with a soft cloth slightly damp with one of the following
interference or turn off the interfering device. cleaning solutions:
• Please make sure the meter and the receiving device are placed within a reasonable • 75% alcohol.
distance (less than five meters) during transmission via Bluetooth. • Super Sani-Cloth disposable wipes.
• Please do not share the meter with other people if you are using Bluetooth transmission • Mild dishwashing liquid with water.
function. The test results from other people will also transmit to the receiving device, and • 10% household bleach solution made in the same day. (1 part bleach with 9 part water)
it will influence your test record. Note:
• The Bluetooth transmission function may not work on certain types of mobile phone due to • Do not allow any wet cloth or liquid to clean your meter.
the compatibility of Android systems. • 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
 Chapter 8 Error Message and Trouble Shooting • Uncompleted test caused by Review the instructions and try again with a
　removing the test strip during new test strip. Please don't remove the strip
Message Cause Solution 　the measurement. before the test is completed.
• Problem with code strip. Repeat the coding procedure and ensure the code
• Insert the strip in an number is the same in label, code strip and
　improper way. screen. Insert the strip again. If the problem • Problem with strip. Review the instructions and try again with
• Problem with test strip. persists, please contact the distributor for service. the same test strip.
If the problem persists, please contact the
• The power of the battery Replace a new battery immediately. distributor for service.
　is too low to run a test.
• Use an improper code Repeat the coding procedure and ensure the
　strip. code number is the same in label, code strip
and screen. If the problem persists, please
• Problem with code strip. Repeat the coding procedure and ensure the code contact the distributor for service.
• Insert the code strip in number is the same in label, code strip and
• Do not get enough Take a new strip and make sure you have
　an improper way. screen. If the problem persists, please contact
　sample volume for the enough sample volume for your test. Repeat
the distributor for service.
　test. the test again. If the problem persists,
• The temperature was Repeat the test after the meter has reached to the please contact the distributor for service.
　below or above the temperature within the operating range. If the • Test result is higher than 1.Review the instructions and try again with
　meter operating range. problem persists, please contact the distributor 　the range listed on Chapter 9. a new test strip.
for service. 2.If the problem persists, please call local
authorized distributor for help.
• An used test strip or a Review the instructions and try again with a new
　damp strip. test strip. • Test result is lower than 1.Review the instructions and try again with
If the problem persists, please contact the 　the range listed on Chapter 9. a new test strip.
distributor for service. 2.If the problem persists, please call local
23 authorized distributor for help. 24
Chapter 9 Specification Electromagnetic Compatibility
This meter meets the electrostatic discharge immunity testing was basic standard
Test Sample Fresh Capillary Whole Blood IEC6100-4-2. In addition, the meter meets the electromagnetic emissions requirements as
Measuring Time GLU:5 seconds; CHOL: 26 seconds; UA: 15 seconds per EN61326. The purpose of these requirements is to ensure that meter does not affect or
Measuring Range GLU: 20-600 mg/dL (1.1 - 33.3 mmol/L); being affected by other devices during operation.
CHOL: 100 - 400 mg/dL ( 2.59 - 10.35 mmol/L );
UA :3 - 20 mg/dL ( 0.18 - 1.19 mmol/L ) Warning :
Sample Volume GLU: 0.7 μL; CHOL: 0.8 μL; UA: 1 μL ● Use of this equipment adjacent to or stacked with other equipment should be
Storage & Transportation avoided because it could result in improper operation. If such use is necessary,
4 - 30˚C (39-86˚F) this equipment and the other equipment should be observed to verify that they
Condition
are operating normally. The BeneCheck Multi-Monitoring Meter may provide a
Operation Temperature 10 - 40˚C (50-104˚F) description or list of equipment with which the BeneCheck Multi-Monitoring
Storage & Transportation Meter has been tested in a stacked or adjacent configuration.
10-90%
Relative Humidity ● Use of accessories, transducers and cables other than those specified or
Memory 460 Test Results (GLU: 360 ; CHOL: 50 ; UA: 50) provided by the manufacturer of this equipment could result in increased
Battery Type One 3V (CR2032) lithium battery electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Battery Life Approximately 1,000 tests
● Portable RF communications equipment (including peripherals such as antenna
Dimensions 88*52*16 mm cables and external antennas) should be used no closer than 30 cm (12 inches)
Weight About 50g (with battery) to any part of the BeneCheck Multi-Monitoring Meter, including cables specified
Altitude 10,000 feet (3048 m) by the manufacturer. Otherwise, degradation of the performance of this
Expected Service Life 5 years equipment could result.
Transmission Function Bluetooth 4.0
Note:
• Please refer to the strip insert for accuracy, precision, limitation, and other important 　　
　information.
25
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.