TYSON BIORESEARCH HS100B Blood Glucose Monitoring System User Manual HS100 B Manual FDA AF004 0068000N 180522
TYSON BIORESEARCH, INC. Blood Glucose Monitoring System HS100 B Manual FDA AF004 0068000N 180522
TysonBio HS100-B- UserMan
User Manual
HS100-B Blood Glucose Monitoring System
Limitations
The Tyson Bio HS100-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 suering 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 oces, 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 Immunodeciency 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 HS100-B Blood Glucose Monitoring System
About Tyson Bio HS100-B Blood Glucose Meter
About Tyson Bio HS100-B Blood Glucose Meter Display
About Tyson Bio HS100-B Blood Glucose Test Strip
About Tyson Bio HS100-B Blood Glucose Test Strip Label
Setting Up Tyson Bio HS100-B Blood Glucose Meter
Installing/Replacing Batteries
Date/Time Setup
Reminder Alarms Setup
HI/LO Alarms Setup
Important Information
Using Tyson Bio HS100-B Blood Glucose Test Strip
Obtaining a Blood Sample
Applying a Blood Sample
HI and LO Readings
01
02
03
04
05
07
08
09
09
10
11
12
13
14
15
17
19
20
21
21
23
24
26
28
29
32
33
36
39
40
42
42
43
44
45
Available Alternate Sites Testing
Control Solution
Performing a Control Solution Test
Control Solution Results
Memory Features
View Day Average Results
Bluetooth Data Transfer
Cleaning and Disinfection Procedure
Care and Storage
Display Messages
Error Messages
Trouble Shooting
Specications
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 HS100-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 HS100-B Blood Glucose Monitoring System. Please read carefully before use.
Tyson Bio HS100-B Blood Glucose meter can be used with:
˙Tyson Bio HS100-B Blood Glucose Test Strip
Intended Use Statement
The Tyson Bio HS100-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 eectiveness 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 HS100-B Blood Glucose Monitoring System is comprised of the Tyson Bio HS100-B Blood Glucose Meter
and Tyson Bio HS100-B 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 Notication: 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 HS100-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:
˙HS100-B Blood Glucose Meter
˙HS100-B Blood Glucose Test Strip
˙HS100-B 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
About Tyson Bio HS100-B Blood Glucose Meter
1. Test Port
2. Strip Ejector
3. Display
4. Button
5. Meter Label
6. Serial Numbers
7. Battery Cover
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
AL001-0239000N (01)
Tyson Bioresearch, Inc.
Zhunan, Taiwan
Blood Glucose Meter
HS100-B
2AJZ6HS100B
04
About Tyson Bio HS100-B Blood Glucose Meter Display
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
14 day average result
1
8
2
3
4
5
6
714
15
16
13
12
11
10
9
05
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.
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.
1
8
2
3
4
5
6
714
15
16
13
12
11
10
9
06
About Tyson Bio HS100-B Blood Glucose Test Strip
1
2
3
top side
Tyson Bio HS100-B Blood Glucose Test Strip is only for Tyson Bio HS100-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. Conrmation Window
To conrm sucient blood sample and control solution
3. Contact Bar
To be inserted into the test port and to activate the meter (top side up)
07
About Tyson Bio HS100-B Blood Glucose Test Strip Label
Test Strip Vial Label Test Strip Vial
Blood Glucose Test Strips
HS100-B
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.
Use Tyson Bio HS100-B meter only !
AL001-0237000N (01) Rev. date: 04/2018
Test Strips
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053,
Taiwan
Tel: +886-37-585998
Customer Service
U.S.A. +1-800-948-3894
Date opened:_____/_____/_____
Control Solution Range
2018-12-25
Blood Glucose Test Strips
HS100-B
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.
Use Tyson Bio HS100-B meter only !
Test Strips
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053,
Taiwan
Tel: +886-37-585998
Customer Service
U.S.A. +1-800-948-3894
Control Solution Range
2018-12-25
08
(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 HS100-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
AL001-0239000N (01)
Tyson Bioresearch, Inc.
Zhunan, Taiwan
Blood Glucose Meter
HS100-B
2AJZ6HS100B
Blood Glucose Test Strips
Use within 6 months after first opening.
Do not use past the expiration date.
Use Tyson Bio HS100-B meter only !
AL001-0237000N (01) Rev. date: 04/2018
Date opened:_____/_____/_____
Control Solution Range
AL001-0239000N (01)
Tyson Bioresearch, Inc.
Zhunan, Taiwan
Blood Glucose Meter
HS100-B
2AJZ6HS100B
AL001-0239000N (01)
Tyson Bioresearch, Inc.
Zhunan, Taiwan
Blood Glucose Meter
HS100-B
2AJZ6HS100B
09
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 conrm (Fig.4).
3. The numbers of “year” will appear and ash. Press or to adjust and Press to conrm (Fig.5).
4. The number of “month” will appear and ash. Press or to adjust and press to conrm (Fig.6).
5. The numbers of “day” will appear and ash. Press or to adjust and press to conrm (Fig.7).
6. The numbers of “hour” will appear and ash. Press or to adjust and press to conrm (Fig.8).
7. The numbers of “minute” will appear and ash. Press or to adjust, and press to conrm (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.
Date/Time Setup
(Fig.4) (Fig.5) (Fig.6) (Fig.7)
(Fig.8) (Fig.9) (Fig.10) (Fig.11)
10
Tyson Bio HS100-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 conrm.
5. The numbers of “minutes” will ash (Fig.15). Press or to adjust and press to conrm. The meter will go to the
next reminder alarm setting.
6. Repeat steps 3 to 5 to set the rest of reminder alarms.
Reminder Alarms Setup
(Fig.12) (Fig.13) (Fig.14) (Fig.15)
11
NOTE:
The hypoglycemic (LO) and hyperglycemic (HI) alarm glucose values should be selected in consultation with
your health care provider.
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 conrm. 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 conrm.
(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 conrm 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)
12
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 HS100-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 HS100-B Blood Glucose Test Strip and Control Solution can be used with the Tyson Bio HS100-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.
13
Preparing the Test Strip
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.15).
Using Tyson Bio HS100-B Blood Glucose Test Strip
(Fig.25)
(Fig.24)
(Fig.22) (Fig.23) (Fig.26)
You need the following items to test
˙Tyson Bio HS100-B Blood Glucose Meter
˙Tyson Bio HS100-B Blood Glucose Test Strip
˙Adjustable lancing device and sterile lancet
14
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 cap 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).
(Fig.27) (Fig.28) (Fig.29) (Fig.30) (Fig.31) (Fig.32)
15
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.28) for detail instructions of meter
maintenance.
(Fig.33)
16
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 conrmation window of the test strip
If applying an insucient blood sample, the error code (E-7) will appear on the display (Fig35).
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.
(Fig.34)
Sucient
Blood
Insucient
blood
(Fig.35) (Fig.36) (Fig.37) (Fig.38)
17
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
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, Classication and Diagnosis of Diabetes, 2017.
Diabetes Care 40(Suppl. 1):S11–S24
18
HI and LO Readings
˙Tyson Bio HS100-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
reconrm the test result.
(Fig.39) (Fig.40)
19
Available Alternate Sites Testing
Palm and Forearm
Tyson Bio HS100-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 dierences in the circulation between the nger and other test sites
may result in dierences 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
20
Control Solution
(Fig.41)
The Control Solution is to ensure that Tyson Bio HS100-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 HS100-B Blood Glucose 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
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)
21
4. Press and hold for 2 seconds to change to the Control Solution test mode. " " will appear on the display
(Fig.43). Press again for 2 seconds and the meter will switch back to the normal testing mode.
5. Discard the rst drop of the Control Solution. Squeeze a small drop on a clean nonabsorbent surface e.g. wax paper.
Do not apply the Control Solution to the test strip directly from the bottle because contamination may occur (Fig.44)
6. Introduce the tip of the test strip to the Control Solution drop. The Control Solution will be automatically drawn into
the strip. Hold until the meter beeps. The meter will now start to count down and the Control Solution test result
will appear on the LCD screen (Fig.45).
Caution:
Follow the above instructions when performing a Control Solution test in order to prevent contamination.
(Fig.45)
(Fig.43) (Fig.44)
22
The Tyson Bio HS100-B Blood Glucose Monitoring System is working properly only if the Control Solution test result
is within the specied range printed on the test strip vial. Please repeat the test when the test result is out of range.
Out of range result may be caused by:
˙Incorrect steps while performing the test
˙The Control Solution temperature is lower than 59°F (15°C) or higher than 95°F (35°C)
˙Expired or contaminated Control Solution
˙Expired or contaminated test strips
˙Meter malfunction
Note:
˙The result will not be included in any day average calculation when the Tyson Bio HS100-B Blood Glucose
meter is set in the Control Solution test mode.
˙DO NOT use Tyson Bio HS100-B Blood Glucose meter if the problem persists. Please contact customer service
immediately.
Control Solution Results
23
How to view results stored in the memory
1. When the meter is o, press button to turn on the meter. The Data and Time will be shown on (At the left-upper
corner. Firstly the year is shown for 1 second, and then Month-Day will be shown on in the same area).
2. Press to view previous results. “MEM” icon will be displayed on the top center area. Initially, the “year” will be
display on the top left corner (Fig.46). After 1 second “month-day” will then be displayed on the top left corner and
“time” will be displayed on the top right corner (Fig.47). The most recent memory results will be displayed rst.
3. You can press or to scroll forwards and backwards through the results.
4. Press button to exit the stored test results or the meter will be shut o automatically after 2 minutes without any
action.
Memory Features
(Fig.46) (Fig.47)
24
Note:
1. A result with or symbol indicates that the reading was taken out of the meter’s specified operating
temperature range and may not be accurate. This value is excluded from the 7/14/30 day average.
(Fig.48)
How to view the control solution test result in the memory
1. When the meter is o, press button to turn on the meter.
2. Press button again, and the lastest control solution test result will be displayed (Fig.48).
3. Press button to turn o the meter or the meter will be shut o automatically after 2 minutes without any action.
25
1. Press to turn the meter on, then Press button to view day
average results.
2. 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.49 ~ 57).
3. When the meter displays 7 days with no meal status assigned,
press button and the meter will then change to view stored
test results in memory.
4. Press button to turn o the meter or the meter will be shut
o automatically after 2 minutes without any action.
View Day Average Results
(Fig.55) (Fig.56) (Fig.57)
(Fig.50) (Fig.51)
(Fig.49)
(Fig.52) (Fig.53) (Fig.54)
26
1. day average
2. meal ag (no meal / pre-meal / post-meal )
3. The number used for day average
4. The average calculated based on day average (upper left), number of results (upper right), meal ag (lower left).
5. The average calculated from all 14 day test results
Note:
1. The consecutive 7/14/30 day average is calculated from the test results obtained during the last
consecutive 7/14/30 day periods.
2
3
4
5
1
27
(Fig.58) (Fig.59) (Fig.60)
Bluetooth Data Transfer
Tranfer Memory Data
1. Press to turn on the meter (Fig.58).
2. When the meter is switched ON, hold for 4 seconds to enter Bluetooth mode. will appear and ash
on the meter when meter is not connected with a mobile device (Fig.59).
3. Turn Bluetooth on your mobile device, and BLE tool APP (with Blood Glucose Test) on.
4. Select the device shown (ex.Tysonbio-BGM) in APP list and click “Connect” . stops blinking when the
meter & mobile device is connected.
5. Press the button on APP to transfer data. The meter will display while data are being transferred (Fig.60).
28
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.
The meter should be disinfected periodically, such as twice per week.
Material
Clorox Bleach Germicidal Wipes (Clorox Professional Products Company. EPA Reg. No. 67619-12).
Signs of deterioration
•Performance: The control solution measurements are out of range which is listed on the test strip label.
•Physical: Polymer crazing (thin silver streaks appear), cracking, swelling, dissolving, softing, or becoming brittle,
and the symbols are not clear in LCD display.
If these signs of deterioration are noted, users should stop using meter and contact customer service.
Customer Service
U.S.A. +1-800-948-3894 24 hours a day, 7 days a week Taiwan
Taiwan +886-37-585998 GMT+8, 8:30 ~ 17:30, Monday ~ Friday
Note:
Users should wash hands thoroughly with soap and water after handling the meter, lancing device, or test strips
should be included.
Cleaning and Disinfection Procedure
29
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.
˙The meter is cleaned follow by the illustrations
(Step1~Step15).
˙Wipe the entire surface of the meter to clean
blood and other body uids.
˙Please avoid using alcohol or organic solvents in
cleaning.
˙Do not immerse the meter in water. Do not allow
water or cleaning uids into the meter, test port,
and data port.
(Step 1) (Step 2) (Step 3) (Step 4)
(Step 5) (Step 6) (Step 7) (Step 8)
(Step 9) (Step 10) (Step 11) (Step 12)
(Step 13) (Step 14) (Step 15)
30
Disinfection:
˙ Cleaning solution and disinfecting solution:
Clorox Bleach Germicidal Wipes
˙ Use a new disinfection wipe.
˙ The meter is cleaned follow by the illustrations
(Step1~Step15).
˙ Wipe the entire surface of the meter to remove
bloodborne pathogens.
˙ Dispose of the used wipe in a trash bin.
˙ Allow exteriors to remain wet for the 1 minute
contact time.
˙ Wipe surface using a towel and allow to air dry.
Cleaning and Disinfection Procedure
(Step 1) (Step 2) (Step 3) (Step 4)
(Step 5) (Step 6) (Step 7) (Step 8)
(Step 9) (Step 10) (Step 11) (Step 12)
(Step 13) (Step 14) (Step 15)
31
Care and Storage
Please handle the meter with care. Dropping the meter may result in damage.
˙Do not expose the meter, test strips, and the Control Solution to extreme conditions such as high humidity, heat,
freezing 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 HS100-B Blood Glucose Monitoring System in the carrying case
provided.
32
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 default setting is 70 mg/dL and it can be
changed according to 《HI/LO Alarms Setup》
The result is LOWER than the “LO” alert
setting.
33
Display Description Action
Test result is HIGHER than 600 mg/dL. Repeat the test by using a new test strip. If the same
message displays again, the result is conrmed to be higher
than the meter test range. Please consult your healthcare
professional immediately for further advice.
Test result is LOWER than 20 mg/dL. Repeat the test by using a new test strip. If the
same message displays again, the result is
conrmed to be lower than the meter test range.
Please consult your healthcare professional
immediately for further advice.
Temperature is TOO HIGH during the
test procedure.
Large variation may occur between results due to high or
low temperature. Move to an environment (50°F ~ 104°F or
10°C ~ 40°C) and wait for 30 minutes before re-testing.
Temperature is TOO LOW during the
test procedure.
Large variation may occur between results due to high or
low temperature. Move to an environment (50°F ~ 104°F or
10°C ~ 40°C) and wait for 30 minutes before re-testing.
34
Display Description Action
The preset reminder alarm is ringing Press any button to turn o the alarm or wait for the alarm to
be turned o automatically in 30 seconds.
Battery power is LOW. Meter will only
provide proximately 10 more
measurements.
Replace with 2 AAA batteries.
1. An error message indicates that the
hematocrit of the blood sample is too
low for the system to perform a test.
2. Use control solution to check the meter
and test strips.
1. Follow the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
2. Follow the instructions to enter control solution mode,
and try again with a new test strip.
An error message indicates that the
hematocrit of the hematocrit of the
blood sample is too high for the system
to perform a test.
Follow the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
35
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.
Temperature is TOO LOW 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.
Battery power is depleted for any further
usage.
Replace with 2 AAA batteries immediately
This message is displayed when your meter
has NOT been coded.
Please contact customer services for assistance.
36
Display Description Action
An error message indicates a problem with
the test strip or meter.
Review the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
An error message indicates a problem with
the test strip.
Review the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
An error message indicates a problem with
the meter.
Remove batteries and wait for 1 minute. Reinstall batteries
to see if meter is working properly. Please contact customer
service if the problem persists.
An error message indicates a problem with
the test strip.
Review the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
37
Display Description Action
An error message indicates a problem with
the meter.
Remove batteries and wait for 1 minute. Reinstall
batteries to see if meter is working properly. Please
contact customer service if the problem persists.
An error message indicates a problem with
the test strip.
Review the instructions and try again with a new test strip.
Please contact customer service if the problem persists.
An error message indicates a problem with
the meter.
Remove batteries and wait for 1 minute. Reinstall
batteries to see if meter is working properly. Please
contact customer service if the problem persists.
An error message indicates insucient
volume of blood sample for the test.
Follow the instructions and try again with a new test strip,
then applying a sucient blood sample to the test strip.
Please contact customer service if the problem persists.
38
Other problems which may occur Action
Trouble Shooting
A test strip has not been inserted into the meter
properly.
Review the instructions and re-insert a test strip
correctly.
Defective test strip. Replace with a new test strip.
A test strip remains in the test port for more than 2
minutes before testing.
Review the instructions and re-insert a test strip
correctly.
LCD display on the meter is blank when trying to
perform a test.
Please contact customer services for assistance.
The meter does not function after new batteries are
installed.
Remove batteries and wait for 1 minute. Reinstall
batteries to see if meter is working properly.
39
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
Test Time 5 seconds countdown
Memory Capacity 500 most recent results
Average 7/14/30 days average
40
Power supply 2 AAA batteries
Battery Life Approximately 1000 tests
Dimension 108L x 55W x 17H mm
Weight 60 g without batteries
Note: Please refer to the Test Strip Insert for the performance of system accuracy and precision.
The Meter meets the electromagnetic compatibility requirements as per IEC 60601-1-2:2014 and EN 60601-1-2:2015.
Caution: Do not use the meter close to the electronic equipment which is a source of strong electromagnetic
radiation, which may interfere with proper operation of meter.
41
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
Batch code
Use by
Do not reuse
Serial Number
Manufacturer
In vitro diagnostic medical device
Consult instructions for use
Sucient for
Catalogue number
ControlCaution
42
Service and Warranty
IMPORTANT
˙The Tyson Bio HS100-B Blood Glucose Meter, Tyson Bio HS100-B Blood Glucose Test Strip and Tyson Bio HS100-B
Control Solution are in conformity with the CFR, Title 21 and IVDD 98/79/EC.
˙Tyson Bio HS100-B Blood Glucose Monitoring System manufacturer warranty is valid only when used properly
within the guidelines of this User Manual provided.
˙The Lancing device and Lancets are in conformity with the CFR, Title 21 and MDD 93/42/EEC.
Manufacturer Warranty
˙Tyson Bioresearch Inc. oers 3 years guarantee on this product. Our company shall repair or replace any Tyson Bio
HS100-B Blood Glucose Monitoring System found defective with a new one.
˙This warranty does not apply to the performance of a Tyson Bio HS100-B 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 HS100-B Blood Glucose
Monitoring System.
˙For manufacturer warranty services, purchaser must contact Tyson Bioresearch, Inc. for help.
43
Federal Communications Commission Interference Statement
15.105
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. These limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment o and on, the user
is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.
-Consult the dealer or an experienced radio/ TV technician for help.
15.21
Any changes or modications not expressly approved by the grantee of this device could void the user's authority to
operate the equipment.
44
The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment.
The equipment must not be co-located or operating in conjunction with any other antenna or transmitter.
15.19
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.
RF Exposure Warning
45
Manufacturer of Blood Glucose Meter, Test Strip and Control Solution
When you call our customer service, please have all components of the product available. This will allow us to
answer your questions with speed and eciency.
Manufacturer of Lancet and Lancing Device
Shandong Lianfa Medical Plastic Products Co., Ltd.
No.1 Shuangshan Sanjian Road 250200 Zhangqiu City, Jinan, Shandong PEOPLE’S REPUBLIC OF CHINA
SteriLance Medical (Suzhou) Inc.
No.68 Litanghe Road,Xiangcheng Suzhou, Jiangsu 215133 P.R.China
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
Tyson Bioresearch, Inc.
5F, No.16, 18, 20, 22, Kedong 3rd Rd., Zhunan Township, Miaoli County 35053, Taiwan
+886-37-585998 www.tysonbio.com
46
AF004-0068000N (01) Rev. date: 04/2018
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
Tyson Bioresearch, Inc.
5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
Zhunan Township, Miaoli County 35053, Taiwan
+886-37-585998 www.tysonbio.com