Tyson Bio HS100-B User Manual

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 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 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 10 11

13 14 15 17 19

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 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 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 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 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.

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

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

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

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

3 4 5

15 16

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.

3 4 5

15 16

About Tyson Bio HS100-B Blood Glucose Test Strip

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. 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)

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

(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

AL001-0237000N (01) Rev. date: 04/2018

Date opened:_____/_____/_____

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

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.

Date/Time Setup

(Fig.4) (Fig.5) (Fig.6) (Fig.7)

(Fig.8)

(Fig.9) (Fig.10) (Fig.11)

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 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.

Reminder Alarms Setup

(Fig.12) (Fig.13) (Fig.14) (Fig.15)

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 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)

+ 35 hidden pages

Tyson Bio HS100-B User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual