Tyson Bio HT100-C Manual
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Tyson Bio HT100-C Manual

Blood glucose test strips
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Limitations
The Tyson Bio HT100-C Blood Glucose Test Strips give accurate results when the following limitations are observed.
Use only capillary whole blood from nger, palm, and forearm.
˙
Do not use for testing neonatal blood.
˙
Altitude higher than 10745 feet may cause inaccurate results.
˙
Severe dehydration and excessive water loss may lead to inaccurate blood glucose test results.
˙
Consult your physician immediately if you believe you are su ering from severe dehydration.
For single-patient use only and should not be shared.
˙
Should not be used to test critically ill patients.
˙
Inaccurate results may occur in severely hypotensive individuals or patients in shock.
˙
Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
˙
For In vitro diagnostic only.
˙
For over the counter use.
˙
Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly).
˙
Alternative site measurements should never be used to calibrate continuous glucose monitors (CGMs).
˙
Alternative site measurements should never be used for insulin dosing calculations.
˙
Warning
•This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician
o ces, or long-term care facilities because it has not been cleared by FDA for use in these settings,
including for routine assisted testing or as part of glycemic control procedures.
•Use of this device on multiple patients may lead to transmission of Human Immunode ciency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

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  • Page 1 Limitations The Tyson Bio HT100-C Blood Glucose Test Strips give accurate results when the following limitations are observed. Use only capillary whole blood from nger, palm, and forearm. ˙ Do not use for testing neonatal blood. ˙ Altitude higher than 10745 feet may cause inaccurate results.

  • Page 2: Table Of Contents

    Table of Content Limitations Introduction Important Safety Instructions About Tyson Bio HT100-C Blood Glucose Monitoring System About Tyson Bio HT100-C Blood Glucose Meter About Tyson Bio HT100-C Blood Glucose Meter Display About Tyson Bio HT100-C Blood Glucose Test Strip Tyson Bio HT100-C Blood Glucose Test Strip...
  • Page 3 Table of Content Control Solution Performing a Control Solution Test Control Solution Results Memory Features View Day Average Results Exiting the Memory Mode Transfer Test Results to a Computer Voice Guidance Bluetooth Guidance Cleaning and Disinfection Procedure Care and Storage Display Messages Error Messages Trouble Shooting...

  • Page 4: Introduction

    It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The Tyson Bio HT100-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose Meter and Tyson Bio HT100-C Blood Glucose Test Strip.

  • Page 5: Important Safety Instructions

    Important Safety Instructions All parts of the system should be considered potentially infectious and are capable of transmitting blood-borne ˙ pathogens between patients and healthcare professionals. The meter and lancing device are for single person use. Do NOT share them with anyone including other family ˙...

  • Page 6: About Tyson Bio Ht100-C Blood Glucose Monitoring System

    About Tyson Bio HT100-C Blood Glucose Monitoring System The complete kit contains: HT100-C Blood Glucose Meter ˙ HT100-C Blood Glucose Test Strip (10 strips) ˙ HT100-C Control Solution Level 2 ˙ Adjustable Automatic Lancing Device ˙ 10 Sterile Lancets ˙...

  • Page 7: About Tyson Bio Ht100-C Blood Glucose Meter

    About Tyson Bio HT100-C Blood Glucose Meter 1. Data Port To connect interface cable for data transferring 2. Display To display results in numbers and icons Button Press and hold to enter reminder alarm and HI/LO alarm setup To adjust numbers and to toggle settings...

  • Page 8: About Tyson Bio Ht100-C Blood Glucose Meter Display

    About Tyson Bio HT100-C Blood Glucose Meter Display 7. Meal Indicator Icon Pre-meal and post-meal 8. 14 day Average 14 day average result 9. Time Time display 10. Blood Drop Icon Flashes when the meter is ready to accept your blood sample to test 11.

  • Page 9: About Tyson Bio Ht100-C Blood Glucose Test Strip

    About Tyson Bio HT100-C Blood Glucose Test Strip Tyson Bio HT100-C Blood Glucose Test Strip is only for Tyson Bio HT100-C Blood Glucose Meter. Use each strip ONCE ONLY! A test strip consists of the following parts: 1. Target Area Where a blood drop or control solution to be applied 2.

  • Page 10: Tyson Bio Ht100-C Blood Glucose Test Strip

    Tyson Bio HT100-C Blood Glucose Test Strip HT100-C HT100 Blood Glucose Test Strips Blood Glucose Test Strips Use within 1 months after first opening. Use within 1 months after first opening. Store at 39 ~ 86°F (4 ~ 30°C), 10~90% RH.

  • Page 11: Setting Up Tyson Bio Ht100-C Blood Glucose Meter

    Setting Up Tyson Bio HT100-C Blood Glucose Meter Make sure the batteries are properly installed ˙ The default is set to January 1st, 0:00 ˙ Please follow instructions to properly setup the meter ˙ Installing/Replacing Batteries 1. Slide and remove the battery cover (Fig.1).

  • Page 12: Reminder Alarms Setup

    (Fig.10) (Fig.11) Reminder Alarms Setup Tyson Bio HT100-C meter provides 4 reminder alarms. All reminder alarms are OFF as default. Please follow these steps to setup reminder alarms. 1. When the meter is OFF, press and hold for 4 seconds or longer to enter setting.

  • Page 13: Hi/Lo Alarms Setup

    HI/LO Alarms Setup 1. Press to enter the HI alarm setting after completing the reminder alarm setup. (with the voice function on, you will hear "Please set your alert value".) 2. Press to set “ON" and press to con rm. If "OFF" is chosen, the meter will skip this setting (Fig.16, 17). 3.

  • Page 14: Important Information

    Users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips. ˙ Only Tyson Bio HT100-C Test Strip and Control Solution can be used with the Tyson Bio HT100-C Blood Glucose Meter. ˙...

  • Page 15: Using Tyson Bio Ht100-C Blood Glucose Test Strip

    Using Tyson Bio HT100-C Blood Glucose Test Strip You need the following items to test Tyson Bio HT100-C Blood Glucose Meter ˙ Tyson Bio HT100-C Blood Glucose Test Strip ˙ Adjustable automatic lancing device and sterile lancet ˙ Preparing the Test Strip 1.

  • Page 16: Obtaining A Blood Sample

    Obtaining a Blood Sample 1. Unscrew the lancing device cap (Fig.27). 2. Place a lancet into the lancing device (Fig.28). 3. Twist and pull to remove the protective lancet cover to expose the sterile needle. Save the cap for later use (Fig.29). 4.

  • Page 17: Applying A Blood Sample

    Applying a Blood Sample SAMPLE MAY BE OBTAINED FROM FINGER, PLAM, OR FOREARM 1. Introduce the tip of the test strip to the drop of blood. Blood sample will be automatically drawn into the test strip (Fig.34) Discard the rst drop of blood sample to prevent contamination. 2.

  • Page 18: Hi And Lo Readings

    HI and LO Readings Tyson Bio HT100-C Blood Glucose Meter is designed to display test results between 20 ~ 600 mg/dL. ˙ If “HI” (Fig.39) appears on the display, it indicates the reading is higher than 600 mg/dL. ˙ If “LO” (Fig.40) appears on the display, it indicates the reading is lower than 20 mg/dL.

  • Page 19: Available Alternate Sites Testing

    Available Alternate Sites Testing Palm and Forearm Tyson Bio HT100-C Blood Glucose Monitoring System provides you alternate sites Palm testing (AST). This system allows you to test on the palm and the forearm with the equivalent results to ngertip testing.

  • Page 20: Control Solution

    Control solution that is not at room temperature when tested may cause out of range results. 2. Insert a Tyson Bio HT100-C test strip, top side up, contact bar end rst, into the test port. The meter will be automatically turned ON (Fig.41).

  • Page 21: Control Solution Results

    Control Solution Results The Tyson Bio HT100-C Blood Glucose Monitoring System is working properly only if the Control Solution test result is within the speci ed range printed on the test strip vial. Please repeat the test when the test result is out of range.

  • Page 22: Memory Features

    Note: The result will not be included in any day average calculation when the Tyson Bio HT100-C Blood Glucose meter is ˙ set in the Control Solution test mode. DO NOT use Tyson Bio HT100-C Blood Glucose meter if the problem persists. Please contact customer service ˙...

  • Page 23: View Day Average Results

    View Day Average Results 1. Press to turn on the meter. 2. Press button to view day average results. (with the voice function on, you will hear "Review average value. " ) 3. 7/14/30 day average results marked with a no meal/ pre-meal/ post-meal and will be displayed on screen in sequence when is pressed (Fig.50~ 57).

  • Page 24: Exiting The Memory Mode

    Transfer Test Results to a Computer You can use Tyson Bio PC Link to transfer test results to your personal computer. Obtain the required software and cable to be ordered separately. For order information please call Customer Service or visit website of www.tysonbio.com 1.

  • Page 25: Voice Guidance

    Voice Guidance Voice Guidance Setup to turn on the meter. will appear. (Fig.59) ˙Press ˙The voice guidance feature is “ON” by default. ˙Please proceed the following steps 1. When the meter is switched o , press and hold for 4 seconds to enter into setting mode. 2.

  • Page 26: Bluetooth Guidance

    Bluetooth Guidance Bluetooth Setup Press to turn on the meter. will appear when HT100-C has been detected (Fig. 64) ˙ Bluetooth is OFF by default. ˙ Please proceed the following steps. ˙ To Transfer Memory Data 1. When the meter is switched ON, hold for 4 seconds to enter Bluetooth mode.
  • Page 27 To Connect via Bluetooth before a Blood Glucose Testing 1. When the meter is switched o , press and hold button for 4 seconds to enter setting. 2. Press to con rm Buzzer setting and enter Bluetooth function setting menu. 3.
  • Page 28 To Connect via Bluetooth after a Blood Glucose Testing 1. When the meter is switched o , press and hold button for 4 seconds to enter setting. 2. Press to con rm Buzzer setting and enter Bluetooth function setting menu. 3.

  • Page 29: Cleaning And Disinfection Procedure

    Cleaning and Disinfection Procedure Cleaning: Cleaning removes visible soil, organic material, and most importantly, blood products. Always clean before disinfecting. The meter should be cleaned whenever it is visibly dirty. Disinfection: Disinfection generally refers to the use of chemical and physical agents, such as chemicals, to destroy the potential inactivity of a material.
  • Page 30 Cleaning and Disinfection Procedure Cleaning: The meter should be cleaned prior to disinfection. ˙ Switch the meter OFF. ˙ Cleaning solution and disinfecting solution: Clorox Bleach ˙ Germicidal Wipes Use a new cleaning wipe. (Step 1) (Step 2) (Step 3) (Step 4) ˙...

  • Page 31: Care And Storage

    ˙ cold, or dust. DO NOT STORE IN DIRECT SUNLIGHT OR AREAS WITH HIGH HUMIDITY AND/OR DUST. ˙ It is advised that you store all parts of Tyson Bio HT100-C Blood Glucose Monitoring System in the carrying case provided. ˙...

  • Page 32: Display Messages

    Display Messages Display Description Action The system is ready to accept a blood sample. Apply a blood sample. The result is HIGHER than the “HI” alert setting. The default setting is 180 mg/dL and it can be changed according to 《HI/LO Alarms Setup》 The result is LOWER than the “LO”...
  • Page 33 1. An error message indicates that the hematocrit of 1. Follow the instructions and try again with a new test strip. the blood sample is too low for HT100-C system to Please contact customer service if the problem persists. perform a test.

  • Page 34: Error Messages

    Error Messages Display Description Action Temperature is TOO HIGH to perform a test. Move to an environment between 50°F ~ 104°F or 10°C ~ 40°C and wait for 30 minutes before re-testing. (with the voice function on, you will hear "Operating temperature error") Temperature is TOO LOW to perform a test.
  • Page 35 Display Description Action An error message indicates a problem with Remove batteries and wait for 1 minute. Reinstall batteries the meter. (with the voice function on, you to see if meter is working properly. Please contact customer will hear " Error 2, Meter error") service if the problem persists.

  • Page 36: Trouble Shooting

    Trouble Shooting Other problems which may occur Action A test strip has not been inserted into the meter Review the instructions and re-insert a test strip properly. correctly. Defective test strip. Replace with a new test strip. A test strip remains in the test port for more than 2 Review the instructions and re-insert a test strip minutes before testing.

  • Page 37: Speci Cations

    Specifications Operation Temperature 50°F ~ 104°F (10°C ~ 40°C) Operation Humidity 10 ~ 90% RH Hematocrit 10 ~ 65% Test Sample Capillary Whole Blood ( ngertip, palm, and forearm) Sample Volume 0.7 µL Measuring Unit mg/dL Measuring Range 20 ~ 600 mg/dL Note: Please refer to the Test Strip Insert for Test Time 5 seconds countdown...

  • Page 38: Meter Storage

    Meter Storage Transport and store at temperature -4°F ~ 122 °F (-20°C ~ 50°C), less than 90% RH. ˙ Precision instrument, do not drop or crush when being transported. ˙ Icon Description Temperature limitation Manufacturer Batch code In vitro diagnostic medical device Use by Consult instructions for use Do not reuse...

  • Page 39: Service And Warranty

    ˙ HT100-C Blood Glucose Monitoring System found defective with a new one. This warranty does not apply to the performance of a Tyson Bio HT100-C Blood Glucose Monitoring System that has been ˙ accidentally damaged, altered, misused, tampered with or abused in anyway. In no event shall our company be liable to the purchaser or any other person for any incidental, consequential, or punitive damages arising from or in anyway connected with the purchase or operation of Tyson Bio HT100-C Blood Glucose Monitoring System.
  • Page 40 Notice Federal Communications Commission (FCC) Statement 15.21 You are cautioned that changes or modi cations not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. 15.105(b) 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.
  • Page 41 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 of the device.
  • Page 42 Manufacturer of Blood Glucose Meter, Test Strip and Control Solution Tyson Bioresearch, Inc. 5F., No. 16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan +886-37-585998 www.tysonbio.com Customer Service U.S.A. +1-800-948-3894 24 hours a day, 7 days a week Taiwan +886-37-585998 GMT+8, 8:30 ~ 17:30, Monday ~ Friday When you call our customer service, please have all components of the product available.

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