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 finger, 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 suffering from severe dehydration.
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 Importa
Table of Content 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 Specifications Meter Storage Icon Description Service and Warranty Federal Communications Commission Interference Statement RF Exposure Warning 21 22 23 23 25 26
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.
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.
About Tyson Bio HS200-B Blood Glucose Monitoring System 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 Note: 25-strips & 50-strips are sold separately. The actual composition is marked on the box. Some of items may not be included.
About Tyson Bio HS200-B Blood Glucose Meter 1. Test Port Insert test strip here 2. Strip Ejector Push to eject the test strip 3. Display To display measuring results and information in numbers and icons 8 4. Button For the operation of the meter. See more in the further chapter 5. Meter Label Manufacturer information 6. Serial Numbers The meter manufacturer serials AL001-0357000N (01) HS200-B Blood Glucose Meter 2AJZ6HS100B Tyson Bioresearch, Inc. Zhunan, Taiwan MxxWGxxxxxx 7.
About Tyson Bio HS200-B Blood Glucose Meter Display 1 2 3 4 5 6 7 8 05 9 10 11 12 13 14 15 16 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.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 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.
About Tyson Bio 50H Blood Glucose Test Strip Tyson Bio 50H Blood Glucose Test Strip is only for Tyson Bio HS200-B Blood Glucose Meter. Use each strip ONCE ONLY! 1 2 A test strip consists of the following parts: 1. Target Area Where a blood drop or control solution to be applied 2. Confirmation Window To confirm sufficient blood sample and control solution 3.
About Tyson Bio 50H Blood Glucose Test Strip Label 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 30˚C 4˚C 50H Blood Glucose Test Strips Use Tyson Bio HS100, HS100-B, HS200, HS200-B meter only! Use within 6 months after first opening. Do not use past the expiration date. Control Solution Range Test Strips Test Strip Vial Label AL001-0119000N (04) Rev.
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 Installing/Replacing Batteries 0-C, HS200, HS200-B 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). AL001-0119000N (03) Rev. date: 01/2019 . Range (Fig.
Setting Date/Time 1. When the meter is off, press and hold for 4 seconds to enter this setting mode. 2. Press or to select “24hr” or “12hr”, and press to confirm (Fig.4). 3. The numbers of “year” will appear and fiash. Press or to adjust and Press to confirm (Fig.5). 4. The number of “month” will appear and fiash. Press or to adjust and press to confirm (Fig.6). 5. The numbers of “day” will appear and fiash. Press or to adjust and press to confirm (Fig.7). 6. The numbers of “hour” will appear and fiash.
Setting Up Reminder Alarms 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 first 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.
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 confirm. 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 confirm. (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.
Setting Up Buzzer and Bluetooth 1. When the meter is turned off , 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 confirm 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 confirm and the meter will be turned off (Fig.23). (Fig.22) 13 (Fig.
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.
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 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.
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 off the depth adjustable cap (Fig.29). 2. Insert a new disposable lancet firmly into the lancet holder (Fig.30). 3. Twist off and set aside the protective cover of the disposable lancet (Fig.31). 4. Replace the depth adjustable cap (Fig.31). 5.
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 fingertip, press the release button.The better puncture sites are on the middle or ring fingers (Fig.34). 8. Squeeze a small drop of whole blood to apply (Fig.35). For further instructions please see the insert provided with the lancing device. (Fig.33) (Fig.34) (Fig.
Applying a Blood Sample to the Test Strip SAMPLE MAY BE OBTAINED FROM FINGER, PALM, 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.36). Discard the first drop of blood sample to prevent contamination. 2. Hold the tip of the test strip touching the blood drop until the meter beeps. 3. If applying insufficient blood sample, the error code (E-7) will appear on the display (Fig. 37). 4.
Test Results 1. The Tyson Bio HS200-B Blood Glucose Meter displays the test result. 2. The LCD of the meter shows the measuring result, the date and the time (Fig. 40) Date Time Test Result (Fig.40) 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, Classification and Diagnosis of Diabetes, 2017. Diabetes Care 40(Suppl.
Ejecting the used Test Strip and Disposing of the Used Lancet Ejecting the used Test Strip 1. After completing the test, push the strip ejector (Fig.41) or use a tissue paper to remove the tset strip. To unload the lancing device 1. After sampling, carefully remove the cap containing the used lancet (Fig.42). 2. Push the exposed tip of the lancet into its Protective Cap (Fig.43). 3. Hold the hub with one hand and push the plunger by thumb to eject the used disposable lancet in appropriate container (Fig.
HI and LO Readings ˙Tyson Bio HS200-B Blood Glucose Meter is designed to display test results between 20 ~ 600 mg/dL. ˙If “HI” (Fig.45) appears on the display, it indicates the reading is higher than 600 mg/dL. ˙If “LO” (Fig.46) appears on the display, it indicates the reading is lower than 20 mg/dL. (Fig.45) (Fig.46) We suggested the testing procedure should be reviewed and the test should be repeated using a new test strip to reconfirm the test result.
Available Alternate Sites Testing Palm and Forearm Tyson Bio HS200-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 fingertip testing. Physiological differences in the circulation between the finger and other test sites may result in differences in blood glucose measurements. Changes in blood glucose may be observed in finger blood samples sooner than blood samples from the alternate sites.
Control Solution The Control Solution is to ensure that Tyson Bio HS200-B Blood Glucose Monitoring System is working properly and you are performing a test correctly. When to Perform a Control Solution Test 1. You use the meter for the first 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.
4. Press and hold for 2 seconds to change to the Control Solution test mode. " " will appear on the display (Fig.49). Press again for 2 seconds and the meter will switch back to the normal testing mode. 5. Discard the first 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.50) 6. Introduce the tip of the test strip to the Control Solution drop.
Control Solution Results The Tyson Bio HS200-B Blood Glucose Monitoring System is working properly only if the Control Solution test result is within the specified range printed on the test strip vial. Please repeat the test when the test result is out of range.
Memory Features How to view results stored in the memory 1. When the meter is off, 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.52).
How to view the control solution test result in the memory 1. When the meter is off, press button to turn on the meter. 2. Press button again, and the lastest control solution test result will be displayed (Fig.54). 3. Press button to turn off the meter or the meter will be shut off automatically after 2 minutes without any action. (Fig.54) 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.
View Day Average Results 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.55 ~ 63). 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.
1 3 4 2 5 1. day average 2. meal flag (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 flag (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.
Transfer Test Results to a Computer You can use software “Tyson Bio PC Link” to transfer test results to your personal computer. Obtain the required software and data cable separately. For order information please call Customer Service or visit website of www.tysonbio.com 1. Tyson Bio PC Link can be downloaded from www.tysonbio.com 2. Follow the instructions provided with software to install the software into your personal computer. 3.
Bluetooth Data Transfer To Transfer Memory Data 1. Press to turn on the meter (Fig.66). 2. Hold for 4 seconds to enter Bluetooth mode. will flash when meter is not connected with a mobile device (Fig.67). 3. Turn on Bluetooth, and BLE tool APP (with Blood Glucose Test) on your mobile device. 4. Select the device shown (ex.Tysonbio-BGM) in APP list and click “Connect” , stops blinking when the meter and mobile device is connected. Meter will be paired with the device that is connected first time.
To Transfer Single Test Data 1. Refer to strip test process (p.15) to proceed the test (Fig.72). 2. Turn on BLE tool APP (with Blood Glucose Test) and Bluetooth on your mobile device after test is completed. 3. Select the device shown (ex. TBMTXXXXXXXX) in APP list and click connect, stops blinking when the meter & mobile device is connected. Meter will be paired with the device that is connected first time. The passkey will be shown on the meter (Fig.73), enter passkey on your device.
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. The meter should be disinfected periodically, such as twice per week.
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) 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).
Cleaning and Disinfection Procedure 35 (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) 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.
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 HS200-B Blood Glucose Monitoring System in the carrying case provided.
Display Messages Display 37 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” alert setting.
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 confirmed 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 confirmed to be lower than the meter test range.
Display Description The preset reminder alarm is ringing Action Press any button to turn off the alarm or wait for the alarm to be turned off automatically in 30 seconds. 1. Battery power is low, icon flashes for 2 Replace with 2 AAA batteries. seconds. Meter can work normally but will only provide approximately 10 more measurements. 2. Battery is depleted, icon flashes continuously. Meter will be shutdown in 5 seconds.
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. This message is displayed when your meter has NOT been coded. Please contact customer services for assistance. 1. Incorrect bluetooth paring passkey. 2.
Display 41 Description Action 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 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 meter. Remove batteries and wait for 1 minute.
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 insufficient volume of blood sample for the test.
Trouble Shooting Other problems which may occur 43 Action 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.
Specifications Operation Temperature Operation Humidity Hematocrit Test Sample 50°F ~ 104°F (10°C ~ 40°C) 10 ~ 90% RH 10 ~ 65% Capillary Whole Blood (fingertip, palm, and forearm) Sample Volume 0.
External Output Power supply Micro USB interface and Bluetooth 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.
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.
Service and Warranty IMPORTANT ˙The Tyson Bio HS200-B Blood Glucose Meter, Tyson Bio 50H Blood Glucose Test Strip and Tyson Bio 50H Control Solution are in conformity with the CFR, Title 21 and IVDD 98/79/EC. ˙Tyson Bio HS200-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.
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.
RF Exposure Warning 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.
RF Exposure Warning 1. The equipment complies with FCC RF exposure limits set forth for an uncontrolled environment. 2. The equipment must not be co-located or operation in conjunction with any other antenna or transmitter. FCC Label Compliance Statement: This device complies with Part 15 of the FCC Rules.
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 Taiwan +886-37-585998 24 hours a day, 7 days a week GMT+8, 8:30 ~ 17:30, Monday ~ Friday 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 efficiency.
