Alltest ACHR-100 User Manual
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Alltest ACHR-100 User Manual

Cholesterol meter
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Cholesterol Meter
User Manual
ACHR-100/100ST
Hangzhou AllTest Biotech Co., Ltd.

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  • Page 1 Cholesterol Meter User Manual ACHR-100/100ST Hangzhou AllTest Biotech Co., Ltd.

  • Page 3: Table Of Contents

    Contents Chapter 1 Introduction .................... 2 Intended Use ..................2 Scope of Application ................2 Product Name and Model Type ............2 Chapter 2 Components and Specifications ............3 Standard Equipment List..............3 Technical Specification ................. 4 Transportation and Storage Conditions ..........4 Operating Conditions ................

  • Page 4: Chapter 1 Introduction

    1.2 Scope of Application The Cholesterol Meter works with specific cholesterol test strips manufactured by Hangzhou AllTest Biotech Co., Ltd. for the quantitative detection of Total Cholesterol (CHOL), High-density Lipoprotein Cholesterol (HDL) and Triglyceride (TRIG) in human whole blood, serum and plasma. It’s for near-patient and laboratory professional in vitro diagnostic use only.

  • Page 5: Chapter 2 Components And Specifications

    Chapter 2 Components and Specifications 2.1 Standard Equipment List After unpacking, check whether components are missing or damaged according to the following packing list. Packing List Description Quantity Remark Cholesterol Meter Control Strips Lancing Device AAA Batteries Carrying Case User Manual Warranty Card Lancing Device Package Insert Control Strip Package Insert...

  • Page 6: Technical Specification

    2.2 Technical Specification Specification Technical Parameters Methodology Reflectance Photometer ≤ 120 s Test Time CHOL: 2.59-12.93 mmol/L(100-500 mg/dL) Measurement Range HDL: 0.39-2.59 mmol/L(15-100 mg/dL) TRIG: 0.51-7.34 mmol/L(45-650 mg/dL) Specimen Whole blood/Serum/Plasma 35 μL(3 in 1 test strip) Specimen Volume 10 μL(Single test strip) Power Source 4 AAA Batteries Units of Measure...

  • Page 7: Operating Conditions

    2.4 Operating Conditions Power supply: 4 AAA batteries  Environment temperature: 15-35 ° C  Relative humidity: ≤80%  Atmospheric pressure: 86 kPa-106 kPa  Do not perform under sunlight or extreme lighting conditions. ...

  • Page 8: Chapter 3 Principle And Structure

    Chapter 3 Principle and Structure 3.1 Operating Principle The Cholesterol Meter is designed to quantitatively detect the concentration of Total Cholesterol (CHOL), High-density Lipoprotein Cholesterol (HDL) and Triglyceride (TRIG) in human whole blood (venous blood and capillary blood), serum and plasma, and estimate patients with risk of Coronary Heart Disease. When the whole blood specimen is added to the sample area of the cholesterol test strip, during the process of uniform and rapid infiltration, the blood cells are filtered out and the plasma spreads to the reaction layer, after the test reacts with...

  • Page 9: Packing Accessories

    2) Rear View Product information Label area Battery Cover Fig 3.2 3) Top View USB Port Code Chip Port Fig 3.3 3.3 Packing accessories 1) Lancing device Fig 3.4 2) Canister of strips (Included in the start kit) Fig 3.5...
  • Page 10 3) AAA Battery Fig 3.6 4) Carrying Case Fig 3.7...

  • Page 11: Chapter 4 Preparation Before Use

    Chapter 4 Preparation before Use 4.1 Checklist upon opening the Box Before opening the box, check the packing is in good condition and box was not damaged during transportation. Open the box carefully, and check the contents according to 2.1Standard Equipment List to ensure it is complete.
  • Page 12 Section 5.4.2 Optical Check for details. Note: Only use the Control Strips manufactured by Hangzhou AllTest Biotech Co., Ltd. for proper function and accurate results. Remove the control strip for immediate use. Put the control strip back immediately and close the canister tightly after use.

  • Page 13: Environment Preparation

    Lancing Device and Sterile Lancets  The lancing device is used with sterile lancets to prick the finger for blood specimen collection. Please refer to the package insert of Lancing Device for detailed information. Fig 4.1 Lancing Device and Sterile Lancet 4.3 Environment Preparation Prior to testing, bring the meter and cholesterol test strips to the environment according to 2.4 Operating Conditions.

  • Page 14: Chapter 5 Instructions For Use

    Chapter 5 Instructions for Use 5.1 Initialization Open the battery compartment cover on the back of the meter.  Install 4 AAA batteries according to the polarity mark in the battery compartment.  Turn on the meter, all icons will be displayed for approx. 2 seconds (Ref Fig 5.1). ...
  • Page 15 Fig 5.2 Press the right or left button to select the target month, short press of the power button to save the month setting and enter the date setting (Ref Fig 5.3). Fig 5.3 Press the right or left button to select the target date, short press of the power button to save the date setting and enter the hour setting (Ref Fig 5.4).

  • Page 16: Meter Switch On/Off

    Fig 5.5 Press the right or left button to select the target minute, short press of the power button to save the minute setting and end the setting (Ref Fig 5.6). Fig 5.6 After initial setting finished, the meter will turn off automatically. 5.2 Meter Switch on/off Turn on: After the battery is properly installed, press the power button to turn on ...

  • Page 17: Insert Code Chip

    5.3 Insert Code Chip A new code chip is provided with each box of cholesterol test strips; insert the code chip into the meter code chip port when the corresponding strips are to be used. Take the code chip from the cholesterol test strips box. Compare the code ...
  • Page 18 Long Press SET No. TEST Fig 5.9 5.4.1 Test Number Set The test number can be set according to this section (Ref Fig 5.10) In test number setting screen, press power button to enter test number setting.  Press the right or left button to set the target test number, press and hold left or ...
  • Page 19 Fig 5.11 Fig 5.12 Insert the control strip into the strip holder in the same direction as the arrows  indicated on the strip (Ref Fig 5.13). Fig 5.13 Press power button to start the optical check, if the meter displays “Yes”, the ...
  • Page 20 Note: The optical check should be performed under the normal lab lighting conditions. Do not perform under sunlight or extreme lighting conditions. 5.4.3 System Settings Press the right or left button to enter the system setting mode as Fig 5.15, and press power button to enter this mode.
  • Page 21 Fig 5.17 2) Time Setting After setting the time unit, user needs to reset the time, please refer to 5.1  Initialization. Press power button to save the time setting and enter into start test number set.  3) Set the start test number Press the right or left button to select “On”...
  • Page 22 Fig 5.19 Press power button to save the unit and enter the Sound setting.  Note: Please check the test unit when view the test results. 5) Sound Press the right or left button to select “On” or “OFF” to set the sound. The sound ...
  • Page 23 Fig 5.21 Press power button to save the Assessment of CHD set and exit the system  settings (Ref Fig 5.22). Fig 5.22 5.4.4 Report Transmit Press the right or left button to select the Report Transmit mode as Fig 5.23. ...
  • Page 24 Fig 5.25 Fig 5.26 5.4.5 Delete Report Press the right or left button to select the Delete Report mode as Fig 5.27.  Fig 5.27 Press power button to enter into this mode, and press the right or left button to ...

  • Page 25: Testing

    5.5 Testing 5.5.1 Specimen Collection The Cholesterol Meter requires a very small specimen which can be whole blood, serum or plasma. Whole blood can be obtained from the venous whole blood or fingertip whole blood, collect the whole blood as follows: Fingertip Blood Collection ...
  • Page 26 Step 4: Carefully screw the lancing device cover back to the lancing device. Avoid contact with the exposed needle. Make sure the cover is fully seated on the lancing device. (Ref Fig 5.32) Fig 5.32 Step 5: Adjust the puncture depth by rotating the lancing device cover. There are a total of 6 puncture depth settings.
  • Page 27 should be heard as the lancing device actives. Gently massage from the base of the finger to the tip of the finger to obtain the required blood volume (Ref Fig 5.35). Fig 5.35 Step 9: Wipe away the first drop of blood. Apply light pressure to obtain the second drop of blood.
  • Page 28 Venous Blood Collection  For fresh venous whole blood specimens, collect the venous blood in a closed container with EDTA or heparin anticoagulants. Whole Blood must be tested within 8 hours of collection. Mix the specimens well before testing in order to ensure the cellular components are evenly distributed.
  • Page 29 Fig 5.39 Note: In the test interface, the test “No.” and “Sample type” are alternately displayed in the upper left corner (Ref Fig 5.39). Insert a cholesterol test strip into the strip holder in the same direction as the  arrows indicated on the strip.
  • Page 30 Fig 5.41 The results are displayed in order (Ref Fig 5.42):   CHOL: Cholesterol  HDL: High-density Lipoprotein  TRIG: Triglyceride Fig 5.42  CHOL/HDL: Rate of Cholesterol and high-density lipoprotein (Ref Fig 5.43) Note：If CHOL and HDL are not in the measurement range, it will show “--”, the meter cannot calculate the rate.

  • Page 31: Test Record Query

    Note: Discard all blood specimens, used cholesterol test strips and materials carefully. Treat all blood specimens as if they were infectious materials. Follow proper precautions and obey all local regulations when discarding blood specimens and materials. The used cholesterol test strip may have biological risk or environment pollution problems, and should be received in the designated container.
  • Page 32 Fig 5.46  HDL value query interface (Ref Fig 5.47) Fig 5.47  TRIG value query interface (Ref Fig 5.48) Fig 5.48 Exit record inquiry: In any query interface, long press the power button to exit the  query mode. 2) Cholesterol Query of measurement results Press power button to enter the report interface.
  • Page 33 Test No. Test time Test Sample Test result items Fig 5.49 Press power button to view the results, “CHOL” results displayed first, press the  right button in sequence to query “HDL” “TRIG” “CHO/HDL” and “LDL” results (Ref Fig 5.42 and Fig 5.43). 3) Assessment of CHD In the LDL query results interface, press right button to enter the CHD ...
  • Page 34 Fig 5.51 PRO method: age, smoking status(✖ or✔ ), history of diabetes(✖ or✔ ), myocardial  infarction(✖ or✔ ), systolic blood pressure should be confirmed, after sequential selection, the assessment of CHD results are display.(Ref Fig 5.52) Fig 5.52...

  • Page 35: Power Saving Mode

    Note: If the result of “CHOL/HDL” displayed “--”, the PRO method can not be used in the CHD risk assessment, and will show “---”. Press the right or left button to select FRA method that not affected by the CHOL/HDL value. CHD assessment results are for clinical reference only.

  • Page 36: Chapter 6 Precautions And Maintaining

    Chapter 6 Precautions and Maintaining 6.1 Precautions Observe the precautions listed below to ensure accurate results and proper operation of the meter. To protection provided by the meter may be impaired if used in a manner not  defined in this user guide. Make sure that the strips are within the expiry period, if not, inaccurate result ...

  • Page 37: Maintenance

    canister to keep them in good working condition. Do not freeze or refrigerate. Keep the control strip clean and do not bend. Do not touch the test area of the strip. Any serious incident that has occurred in relation to device shall be reported to ...

  • Page 38: Replace The Batteries

    holder back.It is recommended that the meter be stored in the carrying case after each use. Take care to avoid getting liquids, residue or other things in the Meter Sensor Area with a cotton swab. Do not scratch the transparent window covering the sensor.
  • Page 39  In order to prolong the service life of the battery, the cholesterol test strip should be removed as soon as possible after the test result is displayed and the corresponding test should be withdrawn.  Please do not use nickel-cadmium or rechargeable batteries. ...

  • Page 40: Chapter 7 Troubleshooting

    Chapter 7 Troubleshooting The meter can work normally if all operations and maintenance are performed according to this user manual. When the meter encounters some abnormal situation, it will display an error message in order to alarm the operator. It is recommended to contact with the distributor or manufacturer for help.
  • Page 41 Hangzhou AllTest Biotech Co., Ltd. Use other brands of code and strips. No code chip in the meter. Insert the code chip that accompanied the Code chip is damaged or box of cholesterol test strips.

  • Page 42: Chapter 8 Service, Repair And Disposal

    If the meter needs to be sent back to manufacturer, please contact local distributor and/ or Hangzhou ALLTEST Biotech Co., Ltd., it normally takes about a week to fix problems. If it turns out not repairable within warranty period, we will replace it with a new one.

  • Page 43: Chapter 9 Manufacturer Information

    Chapter 9 Manufacturer Information Name: Hangzhou AllTest Biotech Co., Ltd. Address: #550, Yinhai Street, Hangzhou Economic & Technological Development Area, Hangzhou, 310018 P. R. China. Tel: +86-571-56267891 Wed: www.alltests.com.cn Email: info@alltests.com.cn Index of Symbols Consult instructions for Contains In vitro...

  • Page 44: Appendix

    (except as noted below). During the stated one year period, AllTest shall replace the unit under warranty with a reconditioned unit or, at its option, repair at no charge a unit that is found to be defective. AllTest shall not be responsible for shipping charges incurred in the repair of such Meter.
  • Page 45 Limitations of liability In no event shall AllTest be liable for indirect, special or consequential damages, even if AllTest has been advised of the possibility of such damages. For warranty service, please contact your local distributor.

  • Page 46: Warranty Card

    B. Warranty Card Please complete this warranty card and mail it to your local distributor to register your purchase within one year of purchase. Purchaser Model Serial Number Date of Purchase Address Telephone Number E-Mail Address...

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