TysonBio HS200-B User manual

Limitations
The Tyson Bio HS200-B Blood Glucose Monitoring System 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.

Table of Content
Limitations
Introduction
Important Safety Instructions
About Tyson Bio HS200-B Blood Glucose Monitoring System
About Tyson Bio HS200-B Blood Glucose Meter
About Tyson Bio HS200-B Blood Glucose Meter Display
About Tyson Bio 50H Blood Glucose Test Strip
About Tyson Bio 50H Blood Glucose Test Strip Label
Setting Up Tyson Bio HS200-B Blood Glucose Meter
Installing/Replacing Batteries
Setting Date/Time
Setting Up Reminder Alarms
Setting Up the HI/LO Alarms
Setting Up Buzzer and Bluetooth
Important Information
Preparing Test Strip
Preparing the Lancing Device and Obtaining a Blood Sample
Applying a Blood Sample to the Test Strip
Test Results
Ejecting the used Test Strip and Disposing of the Used Lancet
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HI and LO Readings
Available Alternate Sites Testing
Control Solution
Performing a Control Solution Test
Control Solution Results
Memory Features
View Day Average Results
Transfer Test Results to a Computer
Bluetooth Data Transfer
Cleaning and Disinfection Procedure
Care and Storage
Display Messages
Error Messages
Trouble Shooting
Specications
Meter Storage
Icon Description
Service and Warranty
Federal Communications Commission Interference Statement
RF Exposure Warning
Table of Content

Introduction
Thank you for choosing Tyson Bio HS200-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 HS200-B Blood Glucose Monitoring System. Please read carefully before use.
Tyson Bio HS200-B Blood Glucose Meter can be used with:
˙Tyson Bio 50H Blood Glucose Test Strip
Intended Use Statement
The Tyson Bio HS200-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. Alternate 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 HS200-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS200-B Blood Glucose Meter
and Tyson Bio 50H Blood Glucose Test Strip.
01

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)http://www.fda.gov/MedicalDevices/Safety/AlertsandNotic
es/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://ww
w.cdc.gov/injectionsafety/blood-glucose-monitoring.html
02

About Tyson Bio HS200-B Blood Glucose Monitoring System
Note: 25-strips & 50-strips are sold separately.
The actual composition is marked on the box. Some of items may not be included.
The complete kit contains:
˙HS200-B Blood Glucose Meter
˙Tyson Bio 50H Blood Glucose Test Strip
˙Tyson Bio 50H Control Solution Level 2
˙Adjustable Lancing Device
˙Sterile Lancets
˙User Manual
˙Quick Reference Guide
˙Test Strip Package Insert
˙Control Solution Package Insert
˙Log Book
˙Carrying case
03

1. Test Port
2. Strip Ejector
3. Display
4. Button
5. Meter Label
6. Serial Numbers
7. Battery Cover
8. Data Port
Insert test strip here
Push to eject the test strip
To display measuring results and information in
numbers and icons
For the operation of the meter. See more in the
further chapter
Manufacturer information
The meter manufacturer serials
To slide open and replace battery
To connect interface cable for data transferring
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About Tyson Bio HS200-B Blood Glucose Meter
Blood Glucose Meter
HS200-B
AL001-0357000N (01)
MxxWGxxxxxx
Tyson Bioresearch, Inc.
Zhunan, Taiwan
2AJZ6HS100B
04

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1. Memory Icon
Appears during memory mode
2. Year/Date
To display year/date
3. Control Solution Icon
Appears during a Control Solution test and indicates its result
as a Control Solution test result
4. Alarm Icon
Appears when an alarm is set
5. Test Result
To display test results
6. Buzzer Icon
Appears while sound setting
7. Meal Indicator Icon
Pre-meal and post-meal
8. 14 day Average
The average glucose result calculated from all 14 day test results
About Tyson Bio HS200-B Blood Glucose Meter Display
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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.
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9. Time
To display time.
10. Blood Drop Icon
Flashes when it’s ready to perform a test and collect a blood sample.
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 the range of operating temperature.
14. Measurement Units
To identify test result units (mg/dL)
15. Battery Icon
Appears when battery power is low.
16. Bluetooth
Bluetooth connection.
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About Tyson Bio 50H Blood Glucose Test Strip
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2
3
top side
Tyson Bio 50H Blood Glucose Test Strip is only for Tyson Bio HS200-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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Blood Glucose Test Strips
50H
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 6 months after first opening.
Do not use past the expiration date.
AL001-0119000N (04) Rev. date: 09/2019
Test Strips
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053,
Taiwan
Tel: [phone]
Customer Service
U.S.A. [phone]
30˚C
4˚C
Use Tyson Bio HS100, HS100-B, HS200, HS200-B meter only!
Blood Glucose Test Strips
50H
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 6 months after first opening.
Do not use past the expiration date.
Test Strips
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053,
Taiwan
Tel: [phone]
Customer Service
U.S.A. [phone]
30˚C
4˚C
Use Tyson Bio HT100, HT100-A, HT100-B, HT100-C, HS200, HS200-B
meter only!
About Tyson Bio 50H Blood Glucose Test Strip Label
Test Strip Vial Label Test Strip Vial
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Control Solution Range
Use within 6 months after first opening.
Do not use past the expiration date.
AL001-0119000N (03) Rev. date: 01/2019
Use Tyson Bio HT100, HT100-A, HT100-B, HT100-C, HS200, HS200-B
meter only!
(Fig.2)(Fig.1) (Fig.3)
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).
Setting Up Tyson Bio HS200-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
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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”, and press to conrm (Fig.4).
3. The numbers of “year” will appear and ash. Press or to adjust and Press to conrm (Fig.5).
4. The number of “month” will appear and ash. Press or to adjust and press to conrm (Fig.6).
5. The numbers of “day” will appear and ash. Press or to adjust and press to conrm (Fig.7).
6. The numbers of “hour” will appear and ash. Press or to adjust and press to conrm (Fig.8).
7. The numbers of “minute”will appear and ash. Press or to adjust, and press to conrm (Fig.9).
8. The set date and time will now be displayed
on screen (Fig.10, Fig.11).
Press to turn o the meter.
9. The meter date/time setting is complete.
Setting Date/Time
(Fig.4) (Fig.5) (Fig.6) (Fig.7)
(Fig.8) (Fig.9) (Fig.10) (Fig.11) 10

Tyson Bio HS200-B Blood Glucose 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.
Setting Up Reminder Alarms
(Fig.12) (Fig.13) (Fig.14) (Fig.15)
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NOTE:
The hypoglycemic (LO) and hyperglycemic (HI) alarm glucose values should be selected in consultation with
your health care provider.
Setting Up HI/LO Alarms
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.
(Fig.16) (Fig.17) (Fig.18) (Fig.19) (Fig.20) (Fig.21)
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Setting Up Buzzer and Bluetooth
1. When the meter is turned o , press and hold for 4 seconds to enter the setting mode.
2. Buzzer feature is "ON" by default, press or to change the setting. Press to conrm and and the meter will
enter to the setting mode of Bluetooth (Fig.22).
3. Bluetooth feature is "ON" by default, press or to change the setting. Press to conrm and the meter will be
turned o (Fig.23).
(Fig.22) (Fig.23)
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Important Information
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 HS200-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 handing the meter, lancing device, or test strips.
˙Only Tyson Bio 50H Blood Glucose Test Strip and Control Solution can be used with the Tyson Bio HS200-B Blood
Glucose Meter.
˙For accurate results, testing must be done within the operating temperature range (50°F ~ 104°F/10°C ~ 40°C).
If the meter is moved to an area appropriate conditions from where is out of operating temperature range, place
the meter for 30 minutes before conducting the testing.
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Preparing the Test Strip
1. Wash hands using soap and warm water. Rinse and dry thoroughly (Fig.24).
2. Please remove protective wrap completely before opening the vial.
3. Take a test strip from the vial and re-cap the vial immediately (Fig.25).
4. Insert the test strip, top side facing up into the test port. The meter will automatically turn on (Fig.26).
5. System checking will appear (Fig.27).
6. A beep will sound, you can press or to select the meal indicator for marking the test as Pre-meal test ,
post-meal test , or no marker (default) (Fig.28) .
7. A blood sample can now be obtained (refer to P.16).
Preparing Test Strip
Before testing, you need the following items:
˙Tyson Bio HS200-B Blood Glucose Meter
˙Tyson Bio 50H Blood Glucose Test Strip
˙Lancing device and sterile lancet
(Fig.27)(Fig.26)(Fig.25)(Fig.24) (Fig.28)
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Preparing the Lancing Device and Obtaining a Blood Sample
1. Hold the depth adjustable cap in one hand and hold hub in the other hand, twist o the depth adjustable cap (Fig.29).
2. Insert a new disposable lancet rmly into the lancet holder (Fig.30).
3. Twist o and set aside the protective cover of the disposable lancet (Fig.31).
4. Replace the depth adjustable cap (Fig.31).
5. Select a depth of penetration by rotating the top portion of the depth adjustable cap until the number matched to
the window (Fig.32).
(Fig.29) (Fig.30) (Fig.31) (Fig.32)
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For further instructions please see the insert provided with the lancing device.
6. Hold the hub in one hand and pull on the plunger in the other hand. The device will be cocked. Release the
plunger; it will go back to its original position near the hub (Fig.33).
7. Place the lancing device against the soft side into ngertip, press the release button.The better puncture sites
are on the middle or ring ngers (Fig.34).
8. Squeeze a small drop of whole blood to apply (Fig.35).
(Fig.33) (Fig.34) (Fig.35)
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.33) for detail instructions of
meter maintenance.
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