BeneCheck Meter Kit Meter (Front Side & Back Side) “S” Button Serial Number Sticker Meter Label LCD Screen Left “ ” Button Ejection Button Test Port Right “ ” Button Battery Battery Lid
LCD Screen Display: Information and test result display ① Code Number Icon ② Result area ③ Hypo/Hyperglycemia Icon ④ Pre/Post-meal tag ⑤ Average(GLU) ⑥ Blood Loading Icon ⑦ System Check ⑧ Memory Mode Icon ⑨ Strip Loading Icon ⑩ Unit Icon ⑪ Low Battery Bluetooth on Beeper Icon Control Solution Temperature Icon Alarm Icon Test Mode Icon
Alert Tones: • Normal Alert: a short “beep” • Warning Alert: 3 short “beeps” • Turning On/ Off: a long “beep” Test Strip : GLU (GDH-FAD)- Glucose KET - Ketone Sample Inlet Electronic Contact Bars KET KET KET KET Code Strip : Contact Bar KET 1048 Test Mode Code
Labelling and Information • Use-by date • Batch code • Manufacturer • Date of Manufacture • Do not re-use • Serial number • Keep dry • CE certification • Consult instructions for use • Keep away from sunlight • In-vitro diagnostic medical device • Caution, consult accompanying documents
• Comply with WEEE Directive 2012/19/EU • Temperature limitation • Use within 3/6 months after first opening • Authorized representative in the European Community • Catalogue number • Humidity limitation
EN Chapter 1 Chapter 2 2.1 2.2 2.3 Introduction.................................................................................. 1 Setting the Meter Installing/ Replacing the Batteries....................................................... 2 Setting up the Meter......................................................................... 2 Code the Meter................................................................................ 3 Chapter 3 3.1 3.2 3.3 How to Perform the Test Perform the Test...........
Chapter 1 Introduction Introduction Please read carefully before using meter kit, and consult healthcare professional before making any important medical decision. Please contact your local customer service for further assistance with the product.
Chapter 2 Setting the Meter 2.1 Installing/ Replacing the Batteries This meter uses 1.5V AAA battery * 2. Please remove the plastic tab under the battery before using. Note: Dispose the batteries according to your local environmental regulations. 1 2 3 2.
2.3 Code the Meter (β-Ketone) • Code your meter when you first use it or open a new retail box of strips. • Make sure the meter is off before you insert the code strip. • Make sure the code on screen, code strip, and strip vial label or single foil pack are the same. BK-SK1 Code 1048 Model mmol/L mmol/L LV1 48 0.1-8 10 2020/12 1048 0.
Chapter 3 How to Perform the Test Materials you need to perform the test: BeneCheck Meter / BeneCheck Test Strip / Lancing Device / Lancets / Tissue or Cotton Ball with 75% Ethanol or Disinfection Wipes 3.1 Perform the Test • Wash and clean your hands with disinfection wipes, and make sure your hands are dry before testing. • Please refer to Lancing Device Instructions for detail procedure. 1 2 3 4 β-K e Total Cholesterol Test Stri p Storage BK-SC2 Self-Testing 7142 109-164 6.1-9.
10 0.7µL µL Glucose/ β-Ketone Fill up FAILED Fill up ok GLU Touch the blood sample with strip. 11 KET Note: Insufficient fill up of blood sample could lead to inaccurate or failed test result. Do not refill the test strip. 12 13 14 15 物醫療廢棄物 Result will show after countdown. Then eject the used strip to biohazard container. The meter will turn off automatically. Pierce used lancet into protective cap. Discard used lancet Recap lancing to biohazard device and container. storage.
3.2 Glucose Ketone Index (GKI) 1 2 4 5 BK-SK1 2020/12 LV1 0.1-8 3 Model K1303190 Control Range Code 1048 mmol/L β-Ketone Test Strip BK-SK1 1048 0.1 - 8 Insert the ketone test strip. 6 Press both and for 3 sec. Then enter GKI mode. Make sure the code number is correct. 7 Insert the glucose test strip. 6 mmol/L 8 Touch the blood sample with strip. Touch the blood sample with strip. 9 Result will show after countdown. Then eject the used strip to biohazard container.
Note: • Please finish the test within 3 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. • Marked open date on new open strip vial, do not use expired strip. • Dropping, bumping or other violent impact will damage the meter or cause malfunction. • Do not use the meter in an environment with possible magnetic, electromagnetic, and radioactive interferences. • Do not inhale or swallow.
3.3 Alternate Site Testing (AST) You can test your glucose from fingertip, palm or forearm. Taking blood from palm or forearm could reduce the pain, but the glucose level changes faster. 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 or 2 hours after meal/ short-acting or rapid-acting insulin analogue/ exercise.
Note: • Sampling from fingertip if your AST test result does not match your health condition. • Repeat puncturing the same spot may cause soreness and calluses. • Do not squeeze the site excessively. It may take longer for sufficient blood sample to form. • Do not use smeared blood sample, please acquire new blood sample. • If you continue failing in getting enough blood samples, please try to get lancets in lower gauge or sample from fingertip instead.
Chapter 4 Meter Memory Function • Glucose - 800 results, capable in counting 7-, 14-, 30-, 60- and 90-day average • Ketone - 200 results • GKI - 200 results The latest test result will replace the oldest when the records exceed maximum memory capacity. The memories start record from 1 to 800 or 1 to 200, include test results and control solution test results. Note: The control results are not included in the average.
Chapter 5 Control Solution Test Control solution is used to check the performance of the kit. 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 or single foil pack for exact range. β-Ketone Test Strip BK-SK1 Control Range LV1 0.1 - 8 1048 mmol/L Control Range LV1 K1303190 2020/12 0.1-8 mmol/L Control Range Model BK-SK1 Code LV1 0.
Chapter 6 Transmission Function for BC010D The meter provides Bluetooth transmission function. It can transmit test results to connected device wirelessly via Bluetooth. The screen show " " means Bluetooth transmission function is working. • The meter with Bluetooth 4.0 can apply to IOS, Android 2.3.3 and above. • The meter complies with IEC 61326-2-6 and the relevant EMC (electromagnetic compatibility) and RF (radio transmission) requirements regulated by US Federal Communications Commission.
Chapter 7 Care and Maintenance 7.1 Storing Your Meter and Strip Meter: • Avoid bump or violent behavior. • Do not use in extremely dry environment. It may cause static discharges. • Do not use under electromagnetic radiation, ex: electrical equipment. • Do not disassemble the meter for any reason. • Keep meter clean by wiping the exterior appearance with tissues or lint-free cloth. • No modification of this equipment is allowed.
Chapter 8 Message 14 Error Message and Trouble Shooting Cause Solution • Problem with code strip. • Problem with test strip. • Insert strip improperly. Repeat the coding procedure (Chapter 2.3) and insert the strip again. If the problem persists, please contact local distributor for service. • Low battery. Replace with new battery. • Problem with code strip or meter. • Insert code strip improperly. Repeat the coding procedure (Chapter 2.3).
• Test incomplete due to removing the strip during measuring. Follow Chapter 3.1 and repeat the test with a new strip. Do not remove the strip before the test is completed. • Improper code strip. Repeat the coding procedure (Chapter 2.3). If the problem persists, please contact local distributor for service. • Sample volume not enough. Repeat the test with a new strip, and make sure the sample volume is enough. If the problem persists, please contact local distributor for service.
Chapter 9 Specification Test Sample Measuring Time Measuring Range Sample Volume Storage & Transportation Condition Operation Temperature Storage & Transportation Relative Humidity Open Vial Relative Humidity Memory Battery Type Battery Life Dimensions Weight Altitude GLU: Fresh Capillary Whole Blood from fingertip, palm, or forearm/ venous blood/ arterial blood KET: Fresh Capillary Whole Blood from fingertip GLU:5 seconds; KET: 10 seconds GLU:20-600 mg/dL (1.1-33.3 mmol/L); KET: 0.1-8 mmol/L GLU: 0.
Chapter 10 Federal Communications Commission (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. You are cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
Contents of the Kit (please check the meter outer box for exact detail) • BeneCheck Knight Blood Glucose & β-Ketone Monitoring Meter (BC0100、BC010D) (with 1.
