BeneCheck BK3-12M-D User Manual

Multi-Monitoring Meter

Check Your Health

Hand in Hand,

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 : +886-2-22053698 FAX : +886-2-22080779 E-mail : service@glbiotech.com.tw

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. )

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.

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

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 ⑪

Code 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.

CHOL

Test Mode

Code

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.

• 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.

• Make sure the meter 　is off.

• Then insert the code 　strip into the test port.

• 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.

203

C H O L

7 1 4 2

Test Strip

7142

Operation

Storage & Transportation

90%

10%

153-229 mg/dL

8.5-12.7 mmol/L

C1303190

2016/01

7142

C H

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.

• 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.

• 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.

• 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.

• Hold the lancing device firmly 　against sampling site.

• Press the release button.

Lancet Holder

Ejection System

Sliding Barrel

Release Button

Depth Indicator/ Adjustable Tip (for fingertip sampling)

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:+86-10-61678701

Operation

Test Strip

Control Range

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.

• 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.

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.

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.

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.

生物醫

療廢棄

物

O-M

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-,21and 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:

GLU Average

CHOL or UA Individal Record

GLU Individal Record

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.

• Shake well and discard

　the first three drops of 　control solution. And 　put one drop onto a 　clean surface.

• 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.

Note:

• 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.

• Press “M” button for 3 seconds

　to enter the control solution 　mode.

Test Strip

Operation

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

90%

10%

New Taipei City 242

MDSS GmbH Schiffgraben 41 30175 Hannover,

FIG-80-SLG10-6B

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.

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.

• 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.

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.

BeneCheck BK3-12M-D User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual