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HumaSens
Glucose Meter
User Manual

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Summary of Contents for Human HumaSens

  • Page 1 Headline HumaSens Glucose Meter User Manual...
  • Page 2: Table Of Contents

    Table of Contents Chapter 1 HumaSens Glucose Meter Chapter 4 Meter Memory Function 1.1 Introduction Chapter 5 Storage and Handling 1.2 Contents of the Kit 1.3 Symbols Chapter 6 Icons and Alert Tones 1.4 System Components 6.1 Screen Icons Chapter 2 Meter Setup 6.2 Alert Tones...
  • Page 3: Chapter 1 Humasens Glucose Meter

    Please read the entire user manual carefully before 10 seconds. using the HumaSens Glucose Meter to test your blood glucose level. This user manual guides you through the Intended Use: operating procedures with illustrated directions and The HumaSens Glucose Meter is designed to measure helps you find the required information.
  • Page 4: Symbols

    Attention Optional: (not included in the standard kit package, please contact your authorized distributor for ordering.) Recap immediately after use [REF] HumaSens Glucose test strips (2x25 strips/box) 17542/25 Use within 3 months after initial opening Lancets (100 pcs) 17543 HumaSens Glucose control solution (2x4 ml)
  • Page 5: System Components

    1.4 System Components Glucose test strip Glucose Meter (Front View) Glucose Meter (Back View) Electrodes Sample entry zone Screen Battery cover Code strip Type plate PC connection port Set button Electrodes M button Strip port Code number...
  • Page 6: Chapter 2 Meter Setup

    Headline Chapter 2 Meter Setup Before first use, remove the transparent two seconds. The meter will beep once protective foil from the battery. and enter the setup mode. In setup mode, the LCD screen of the 2.1 Replacing the Battery meter shows all setting options conse- The battery is located inside the meter.
  • Page 7 B. Click the “Set” button, and the day segment starts flashing. 3. Set the Day A. Click “M” button until the correct day appears. B. Click the “Set” button, and the hour segment will start flashing. 4. Set the Hour A.
  • Page 8: Coding The Meter

    2.3 Coding the Meter Index A. A flashing “C.OFF” or “C. ON” will appear on the screen. This indicates The HumaSens Glucose Meter must be whether entering the patient condition coded before testing with HumaSens test index during measurement mode is strips for the first time, or every time a...
  • Page 9: Control Test

    ” should control solution is to check the perfor- appear on the screen, indicating that the mance of the HumaSens Glucose Meter. meter has been successfully coded to the The system is performing correctly if the respective test strip lot.
  • Page 10 5. Bring the sample inlet of the test strip > You should check system performance in contact with the drop of control with the HumaSens Glucose control so- solution until the meter beeps. The lution regularly or anytime you suspect screen will display a countdown from that test results are inaccurate.
  • Page 11: Chapter 3 Performing A Test

    Performing a Test 3.1 Before Testing Note: > Please read this user manual and the package insert for HumaSens control Please follow these step-by-step instruc- solution before use. tions to ensure accurate test results. > The vial should be shaken well before Materials required to perform a blood use.
  • Page 12 > Lancets must not be reused. enabled during setup, one of the > Always use a lancet supplied by following indices will appear on the HUMAN to ensure safety. screen: “BEF” (before meal), “AFT” (after Š The lancing device must not meal), or “ACT”...
  • Page 13: Test Procedures For Blood Glucose

    Headline 3.2 Test Procedure for Blood Glucose glucose concentration will be displayed on the screen. 1. After choosing the appropriate index, press the “Set” button to enable loading Note: the blood sample. Take a blood sample > After lancing, make sure to wipe off the according to the instructions for the first drop of blood to avoid contamination “M”...
  • Page 14: Safety Instructions

    Chapter 4 Meter Memory Function test strip. If your reading is not consistent with your symptoms, please contact a healthcare professional. The HumaSens Glucose Meter automatically stores up to 3.3 Safety Instructions 360 blood glucose results or control test results. It also provides you with 7-, 14-, 21- and 28-day averages of the 1.
  • Page 15: Chapter 5 Storage And Handling

    Chapter 5 Storage & Handling Chapter 4 Meter Memory Function 2. Press the “M” button once to switch on the meter. The performance of test strips may be affected by im- After a short “beep” a full display will appear on screen, proper storage and handling.
  • Page 16: Chapter 6 Icons And Alert Tones

    Chapter 6 Icons and Alert Tones 6.1 Screen Icons 6.2 Alert Tones Information is displayed on the screen > Normal Alert Sound: short “beep” by means of easy-to-understand icons. > Warning Alert Sound: 5 short “beeps” > Switching On/Off Alert Sound: long “beep” Test mode Memory retrieval Coding in process...
  • Page 17: Chapter 7 Error Messages And Troubleshooting

    The test strip was removed prematurely. Do not remove the test strip until the measurement is completed. Meter software problem. Please contact your authorized distributor for assistance. Only use HUMAN code strips. Non-authorized code strip. No display. Remove the transparent protective foil from the battery.
  • Page 18: Chapter 8 Specifications

    Chapter 8 Specifications System Accuracy: ± 20% at glucose level ≥75 mg/dl (4.17 mmol/l) ± 15 mg/dl (0.83 mmol/l) at glucose level < 75 mg/dl (4.17 mmol/l) Principle: Electrochemical biosensor Calibration: Plasma-equivalent Test Sample: Fresh capillary whole blood Measuring Time: 10 seconds Measuring Range: 20 –...
  • Page 19: Chapter 9 Limitations Of Blood Glucose Tests

    Latest information on test limitations can be found in patient samples have not been tested and are not the package insert of the Glucose test strips. recommended for testing with HumaSens Glucose test strips. Additional Information for Healthcare Professionals: >...
  • Page 20 HUMAN Gesellschaft für Biochemica und Diagnostica mbH 0483 Max-Planck-Ring 21 [IVD] 65205 Wiesbaden · Germany Tel. +49 6122-9988-0 Fax +49 6122-9988-100 e-mail: human@human.de www.human.de...

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