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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.

2

3

4

5

1

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Summary of Contents for HS200-B

Page 1: ...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...

Page 2: ...lood 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...

Page 3: ...tion 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 T...

Page 4: ...r the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips forearm or palm Alternate site testing should be performed only during steady state when gluc...

Page 5: ...sinfecting Solution Clorox Bleach Germicidal Wipes Clorox Professional Products Company EPA Reg No 67619 12 Reference FDA Public Health Notification Use of Fingerstick Devices on More than One Person...

Page 6: ...n 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 Devic...

Page 7: ...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 in...

Page 8: ...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 Indica...

Page 9: ...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...

Page 10: ...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 Confirmation Window To confirm suffici...

Page 11: ...585998 Customer Service U S A 1 800 948 3894 30 C 4 C Use Tyson Bio HS100 HS100 B HS200 HS200 B meter only Blood Glucose Test Str 50H Con Store at 39 86 F 4 30 C 10 90 RH Do not refrigerate Do not st...

Page 12: ...er 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 M...

Page 13: ...ss 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 Press or to adjust and press to confirm Fig 8 7...

Page 14: ...2 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 flashing Fig...

Page 15: ...ill 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...

Page 16: ...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...

Page 17: ...re 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...

Page 18: ...rt 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 te...

Page 19: ...ap 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...

Page 20: ...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 Fig 33 Fig 34 Fig 35 CAUTION...

Page 21: ...e E 7 will appear on the display Fig 37 4 The meter will start to countdown as soon as the blood has completely filled the confirmation window of the test strip The test result will appear on the disp...

Page 22: ...m the American Diabetes Association Classification and Diagnosis of Diabetes 2017 Diabetes Care 40 Suppl 1 S11 S24 Test Results 1 The Tyson Bio HS200 B Blood Glucose Meter displays the test result 2 T...

Page 23: ...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 lan...

Page 24: ...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 We suggested the testing procedure...

Page 25: ...poglycemia low blood glucose we recommend that you test on your fingertips There are limitations for doing AST Please consult your healthcare professional before you do AST AST measurements should not...

Page 26: ...Test Strip top side up contact bar end first into the test port The meter will be automatically turned ON Fig 47 3 A beep will sound and the system checking will appear followed by a flashing icon Fig...

Page 27: ...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 The Control Solution wil...

Page 28: ...erforming 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...

Page 29: ...yed on the top center area Initially the year will be display on the top left corner Fig 52 After 1 second month day will then be displayed on the top left corner and time will be displayed on the top...

Page 30: ...uded from the 7 14 30 day average Fig 54 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 contr...

Page 31: ...quence 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 Press button to turn...

Page 32: ...e 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 calc...

Page 33: ...d from www tysonbio com 2 Follow the instructions provided with software to install the software into your personal computer 3 Connect the data cable to a data port on your computer while the meter is...

Page 34: ...en the meter and 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 68 please enter passkey on your device If the p...

Page 35: ...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...

Page 36: ...o 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 sw...

Page 37: ...e meter is cleaned follow by the illustrations Step1 Step15 Wipe the entire surface of the meter to clean blood and other body fluids Please avoid using alcohol or organic solvents in cleaning Do not...

Page 38: ...tep15 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...

Page 39: ...eter 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 t...

Page 40: ...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...

Page 41: ...isplays again the result is confirmed 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...

Page 42: ...or 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 aga...

Page 43: ...ature 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 1 Incor...

Page 44: ...tructions 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 Reinsta...

Page 45: ...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...

Page 46: ...hich 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 t...

Page 47: ...Humidity 10 90 RH Hematocrit 10 65 Test Sample Capillary Whole Blood fingertip palm and forearm Sample Volume 0 7 L Measuring Unit mg dL Measuring Range 20 600 mg dL Test Time 5 seconds countdown Memo...

Page 48: ...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...

Page 49: ...iagnostic medical device Consult instructions for use Sufficient for Catalogue number Control Caution Manufacturing Date Meter Storage Transport and store at temperature 4 F 122 F 20 C 50 C less than...

Page 50: ...offers 3 years guarantee on this product Our company shall repair or replace any Tyson Bio HS200 B Blood Glucose Monitoring System found defective with a new one This warranty does not apply to the p...

Page 51: ...ntee 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...

Page 52: ...etermined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures The user is encouraged to try to correct the interferen...

Page 53: ...abel Compliance Statement 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 mus...

Page 54: ...product available This will allow us to answer your questions with speed and efficiency 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...

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