TysonBio HT100-B User manual

The Tyson Bio HT100-B 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.
Limitations
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.

Limitations
Introduction
Important Safety Instructions
About Tyson Bio HT100-B Blood Glucose Monitoring
System About Tyson Bio HT100-B Blood Glucose Meter
About Tyson Bio HT100-B Blood Glucose Meter Display
About Tyson Bio HT100-B Blood Glucose Test Strip Setting
Up Tyson Bio HT100-B Blood Glucose Meter
Installing/Replacing Batteries
Date/Time Setup
Reminder Alarms Setup
HI/LO Alarms Setup
Important Information
Using Tyson Bio HT100-B Code-Calibration Blood Glucose Test Strip
Obtaining a Blood Sample
Applying a Blood Sample
HI and LO Readings
Available Alternate Sites Testing
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Table of Content

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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
Bluetooth Data Transfer (HT100-B Only)
Cleaning and Disinfection Procedure
Care and Storage
Display Messages
Error Messages
Trouble Shooting
Specications
Meter Storage
Icon Description
Service and Warranty

Introduction
Thank you for choosing Tyson Bio HT100-B Blood Glucose Monitoring System to monitor your blood glucose (sugar) level.
It is accurate, easy to use, and quick in response time. This User Manual contains all information needed to operate and
maintain Tyson Bio HT100-B Blood Glucose Monitoring System. Please read carefully before use.
Tyson Bio HT100-B Blood Glucose meter can be used with:
˙Tyson Bio HT100-B Blood Glucose Test Strip
Intended Use Statement
The Tyson Bio HT100-B Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the ngertips, forearm, or palm. Alterative site testing should be performed
only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use).
It is intended for self-testing by people with diabetes at home as an aid to monitor the eectiveness of diabetes control. 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-B Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-B Blood Glucose Meter and
Tyson Bio HT100-B Blood Glucose Test Strip.
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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
members!
˙All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you
have performed cleaning and disinfection.
˙Cleaning Solution and Disinfecting Solution: Clorox Bleach Germicidal Wipes (Clorox Professional Products Company. EPA
Reg. No. 67619-12).
Reference:
˙˙“ FDA Public Health Notication: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication”(2010)https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm234889.htm
˙“ CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood-borne
Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
˙“ CDC: Infection Prevention during Blood Glucose Monitoring and Insulin Administration”(2010) https://www.cdc.gov/
injectionsafety/blood-glucose-monitoring.html
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Note: 25-strips & 50-strips are sold separately.
About Tyson Bio HT100-B Blood Glucose Monitoring System
The complete kit contains:
˙HT100-B Blood Glucose Meter
˙HT100-B Blood Glucose Test Strip (10 strips)
˙HT100-B Control Solution Level 2
˙Adjustable Automatic Lancing Device
˙10 Sterile Lancets
˙User Manual
˙Quick Reference Guide
˙Test Strip Package Insert
˙Control Solution Package Insert
˙Log Book
˙Carrying case
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1. Data Port To connect interface cable for data transferring
2. Display To display results in numbers and icons
3. Button Press and hold to enter reminder alarm and HI/LO alarm setup
To adjust numbers and to toggle settings
To browse test results and averages in memory
4. Button Press and hold to enter buzzer setup
To adjust numbers & to toggle settings
To browse test results and averages in memory
5. Button Press and hold to enter the year/date/time setting
To browse Control Solution test results
To turn the meter ON/OFF
6. Strip Ejector Push to eject the test strip
7. Test Port The test strip is inserted here
8. Battery Cover To slide open and close
9. Meter Label Manufacturer information
10. Serial Numbers The meter manufacturer serials
About Tyson Bio HT100-B Blood Glucose Meter
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Note: The mg/dL is the standard unit in the United States. Meters used in the United States must be set to read in mg/dL".
About Tyson Bio HT100-B Blood Glucose Meter Display
1. Memory Icon
Memory mode
2. Year/Date
Display year/date
3. Control Solution Icon
Control Solution test mode and Control Solution test result
4. Alarm Icon
Reminder alarm
5. Test Result
Result display
6. Buzzer Icon
When buzzer is ON
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. Warning Icon
Appears when a result is out of range
12. Test Strip Icon
Appears when the meter is ready for a test
13. Temperature Icon
Appears when the meter exceeds normal operating
temperatures
14. Measurement Units
To identify test result units (mg/dL)
15. Battery Icon
Appears when battery power is low
16. Bluetooth icon
When Bluetooth is on
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About Tyson Bio HT100-B Blood Glucose Test Strip
Tyson Bio HT100-B Blood Glucose Test Strip is only for Tyson Bio HT100-B 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. Conrmation Window
To conrm sucient blood sample and control solution
3. Contact Bar
To be inserted into the test port and to activate the meter (top side up)
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top side
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Blood Glucose Test Strips
HT100
Control Solution Range
Store at 39 ~ 86°F(4 ~ 30°C), 10~90% RH.
Do not refrigerate.
Do not store test strips outside this vial.
Re-cap immediately.
WARNING: Always close cap tightly.
For testing of glucose in capillary whole blood.
Use within 1 months after first opening.
Do not use past the expiration date.
Use Tyson Bio HT100 meter only !
Test Strips
Tyson Bioresearch, Inc.
5F, No. 16 , 18 , 20 , 22 , Kedong 3rd RD. ,
Zhunan Township , Miaoli County 35053 ,
Taiwan (R.O.C.)
Tel : [phone]
Customer Service
U.S.A. [phone]
30˚C
4˚CLevel 1: ~ mg/dL
Level 2: ~ mg/dL
Level 3: ~ mg/dL
Tyson Bio HT100-B Blood Glucose Test Strip
Test Strip Vial Label Test Strip Vial
Blood Glucose Test Strips
HT100-B
Control Solution Range
Store at 39 ~ 86°F(4 ~ 30°C), 10~90% RH.
Do not refrigerate.
Do not store test strips outside this vial.
Re-cap immediately.
WARNING: Always close cap tightly.
For testing of glucose in capillary whole blood.
HT100-B
Use within 1 months after first opening.
Do not use past the expiration date.
Use Tyson Bio HT100-B meter only !
AL001-0119000N (01) Rev. date: 12/2016
Test Strips
Tyson Bioresearch, Inc.
5F, No. 16 , 18 , 20 , 22 , Kedong 3rd RD. ,
Zhunan Township , Miaoli County 35053 ,
Taiwan (R.O.C.)
Tel : [phone]
Customer Service
U.S.A. [phone]
30˚C
4˚CLevel 1: ~ mg/dL
Level 2: ~ mg/dL
Level 3: ~ mg/dL
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Installing/Replacing Batteries
1. Slide and remove the battery cover (Fig.1).
2. Install batteries with the + and – ends matching indication marks
on the battery compartment (Fig.2).
3. Slide battery cover back into place (Fig.3).
Date/Time Setup
1. When the meter is o, press and hold for 4 seconds to enter this setting mode.
2. Press or to select “24hr” or“12hr”.
3. Press to conrm (Fig.4).
4. The numbers of “year” will appear and ash. Press or to adjust and Press to conrm (Fig.5).
5. The number of“month”will appear and ash. Press or to adjust and press to conrm (Fig.6).
6. The numbers of “date” will appear and ash. Press or to adjust and press to conrm (Fig.7).
7. The numbers of “hour” will appear and ash. Press or to adjust and press to conrm (Fig.8).
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Setting Up Tyson Bio HT100-B 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
(Fig.2)(Fig.1) (Fig.3)
(Fig.4) (Fig.5) (Fig.6) (Fig.7) (Fig.8)
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Tyson Bio HT100-B 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.
2. The rst reminder alarm will appear on the display (Fig.12).
3. Press or to select “ON”or “OFF”.
4. If “OFF” is chosen and pressed, the meter will proceed to the next reminder alarm setting. If “ON” is chosen (Fig.13) and
pressed, the number of“hour” will start ashing (Fig.14). Press or to adjust and press to conrm.
5. The numbers of “minutes” will ash (Fig.15). Press or to adjust and press to conrm. The meter will go to the next
reminder alarm setting.
6. Repeat steps 3 to 5 to set the rest of reminder alarms.
8. The numbers of “minute” will appear and ash. Press or to
adjust. Press to conrm (Fig.9).
9. The set date and time will now be displayed on screen
(Fig.10, Fig.11). Press to turn o the meter.
10. The meter date/time setting is complete.
(Fig.9) (Fig.10) (Fig.11)
Reminder Alarms Setup
(Fig.12) (Fig.13) (Fig.14) (Fig.15) 09

HI/LO Alarms Setup
1. Press to enter the HI alarm setting after completing the reminder alarm setup.
2. Press or to set “ON" and press to conrm. If "OFF" is chosen, the meter will skip this setting (Fig. 16, 17).
3. To change the alarm setting, press or until you reach your desired HI setting and then press to conrm. (Fig.18)
The HI alarm value range is 100 ~ 400mg/dL and the default value is 180mg/dL.
4. Continue to the LO alarm setting (Fig.19), repeat Step 2 and 3 (Fig.20, 21) to conrm or to change LO alarm setting.
The LO alarm value range is 40 ~ 90mg/dL and the default value is 70mg/dL.
5. Press to nish setting and the meter will be turned o.
NOTE:
The hypoglycemic (LO) and hypoglycemic (HI) alarm glucose values should be selected in consultation with your
health care provider.
(Fig.16) (Fig.17) (Fig.18) (Fig.19) (Fig.20) (Fig.21)
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Before Testing
˙Always keep test strips in the original vial. The vial contains drying agents to protect the test strips from moisture.
˙Tightly close the vial cap immediately after removing a test strip.
˙Use each strip immediately after removing it from the vial.
˙Use each test strip ONCE ONLY.
˙Do not use the test strips or Control Solution beyond the expiration date printed on the package. This may cause
inaccurate results.
˙Do not use the test strips or Control Solution if the package is damaged.
˙Store your test strips and the Control Solutions between 39°F ~ 86°F (4°C ~ 30°C)
Temperature beyond this range can damage test strips and lead to inaccurate results.
˙Any change of medications based on the Tyson Bio HT100-B Blood Glucose Monitoring System results without advices of
a doctor is NOT RECOMMENDED.
˙The lancing device is intended only for single user and should NOT be shared.
˙Users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips.
˙Only Tyson Bio HT100-B Test Strip and Control Solution can be used with the Tyson Bio HT100-B Blood Glucose Meter.
Important Information
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Preparing the Test Strip
You need the following items to test
˙Tyson Bio HT100-B Blood Glucose Meter
˙Tyson Bio HT100-B Blood Glucose Test Strip
˙Adjustable automatic lancing device and sterile lancet
1. Wash hands using soap and warm water. Rinse and dry thoroughly (Fig. 22).
2. Please remove protective wrap completely before opening the vial.
3. Take a test strip from the vial and re-cap immediately (Fig.23).
4. Insert the test strip top side up into the test port (Fig. 24). The meter will be automatically turned on.
5. System checking will appear (Fig.25).
6. A beep will sound and following by a ashing “ ”icon. You can press or to select the meal indicator for
marking the test as (Fig.26):
˙Pre-Meal Test
˙Post-Meal Test
˙No marker as default
7. A blood sample can now be obtained (refer to P.13).
(Fig.25)
(Fig.22) (Fig.23) (Fig.26)
(Fig.24)
Using Tyson Bio HT100 Blood Glucose Test Strip
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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. Screw the lancing device cap back on. Select the skin penetration depth preferred (Fig.30).
5. Pull the barrel back until you hear a 'click' (Fig.31).
6. Place the lancing device against the nger, palm, or forearm. Press the trigger to obtain a blood sample (Fig.32).
To unload the lancing device
1. After sampling, carefully remove the cap containing the used lancet.
2. Push the exposed tip of the lancet into its Protective Cap (Fig.33).
Slide the Lancet Ejector forward and dispose the used lancet in an appropriate container.
For further instructions please see the insert provided with the lancing device.
CAUTION:
To reduce chances of infection:
˙Lancets are for single usage only.
˙Wash hands thoroughly with soap and water before and after handling the meter, lancing device, and test strips.
˙Please refer to section "Cleaning and Disinfection Procedure" (refer to P.25) for detail instructions of meter
maintenance.
(Fig.27) (Fig.28) (Fig.29) (Fig.30) (Fig.31) (Fig.32) (Fig.33)
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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. Hold the tip of the test strip touching the blood drop until the meter beeps.
3. The meter will start to countdown as soon as the blood has completely lled the conrmation window of the test strip.
If applying an insucient blood sample, the error code (E-7) will appear on the display (Fig. 35).
4. The test result will appear on the display in 5 seconds (Fig.36). All results will be automatically stored into the meter
memory (Fig.37).
5. The meter will automatically turn o after 2 minutes.
6. After completing the test, push the strip ejector (Fig.38) or use a tissue paper to remove the test strip.
Normal Glucose Values
Before a meal (fasting) : <100 mg/dL
2 h after a meal: < 140mg/dL.
These ranges were cited from the American Diabetes Association, Classication and Diagnosis of Diabetes, 2017.
Diabetes Care 40(Suppl. 1):S11–S24
Warning:
˙DO NOT point the test strip at anyone when ejecting.
˙Used lancets and test strips are considered bio-hazardous. Dispose of used lancets and test strips in a clinical waste container
(Fig.34)
Sufficient
Blood
Insufficient
Blood
(Fig.35) (Fig.36) (Fig.37) (Fig.38)
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HI and LO Readings
˙Tyson Bio HT100-B 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.
We suggested the testing procedure should be reviewed and the test should be repeated using a new test strip to reconÿrm
the test result.
(Fig.39) (Fig.40)
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Available Alternate Sites Testing
Palm and Forearm
Tyson Bio HT100-B Blood Glucose Monitoring System provides you alternate sites
testing (AST). This system allows you to test on the palm and the forearm with the
equivalent results to ngertip testing.
Physiological dierences in the circulation between the nger and other test sites may
result in dierences in blood glucose measurements. Changes in blood glucose may be
observed in nger blood samples sooner than blood samples from the alternate sites. If
you are testing for hypoglycemia (low blood glucose), we recommend that you test on
your ngertips.
There are limitations for doing AST.
Please consult your healthcare
professional before you do AST.
AST measurements should not be used to
calibrate continuous glucose monitors
(CGMs).
AST measurements should not be used for
insulin dose calculations.
Forearm
Palm
AST ONLY in the following intervals:
˙In a pre-meal or fasting state
(more than 2 hours since the last meal)
˙Two hours or more after taking insulin
˙Two hours or more after exercise
DO NOT use AST if:
˙You think your blood glucose is low
˙You are unaware of hypoglycemia
˙Your AST results do not match the way you feel
˙You are testing for hyperglycemia
˙Your routine glucose results are often uctuating
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Control Solution
The Control Solution is to ensure that Tyson Bio HT100-B Blood Glucose Monitoring System is working properly and you are
performing a test correctly.
When to Perform a Control Solution Test
1. Be sure of the Control Solution is at a room temperature between 59°F ~ 95°F (15°C ~ 35°C) before
testing.
Control solution that is not at room temperature when tested may cause out of range results.
2. Insert a Tyson Bio HT100-B test strip, top side up, contact bar end rst, into the test port. The meter will
be automatically turned ON (Fig.41).
3. A beep will sound and the system checking will appear followed by a ashing “ ” icon (Fig.42).
Performing a Control Solution Test (Fig.41)
1. You use the meter for the rst time.
2. You use a new vial of test strips.
3. You suspect that the meter or test
strips are not working properly.
4. Your test results are not consistent with how you feel.
5. You think your test result is not accurate.
6. You damage your meter.
7. An advice from your healthcare professional.
Note: Please read the Control Solution package insert for more detail information.
(Fig.42)
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