Tyson Bio HS100-B, User Manual

Page 1: ...User Manual HS100 B Blood Glucose Monitoring System...

Page 2: ...r 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 ste...

Page 3: ...ut 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 Rem...

Page 4: ...l Solution Results Memory Features View Day Average Results Bluetooth Data Transfer Cleaning and Disinfection Procedure Care and Storage Display Messages Error Messages Trouble Shooting Specifications...

Page 5: ...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 6: ...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 7: ...rked 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 Ster...

Page 8: ...ip 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...

Page 9: ...n 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 Appear...

Page 10: ...lood 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 operatin...

Page 11: ...S100 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 suf...

Page 12: ...trips 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 Sol...

Page 13: ...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 2...

Page 14: ...ess 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...

Page 15: ...g 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 flashing F...

Page 16: ...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 va...

Page 17: ...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...

Page 18: ...ned on 5 System checking will appear Fig 25 6 A beep will sound and following by a flashing icon You can press or to select the meal indicator for marking the test as Fig 26 Pre Meal Test Post Meal Te...

Page 19: ...p 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...

Page 20: ...cet 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 thor...

Page 21: ...art to countdown as soon as the blood has completely filled the confirmation window of the test strip If applying an insufficient blood sample the error code E 7 will appear on the display Fig35 4 The...

Page 22: ...io hazardous Disposeofusedlancetsandteststripsinaclinicalwaste 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 Diabe...

Page 23: ...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...

Page 24: ...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 25: ...e Test Strip top side up contact bar end first 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 flashing icon F...

Page 26: ...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 wil...

Page 27: ...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 28: ...yed 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...

Page 29: ...uded 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 off press button to turn on the meter 2 Press button again and the lastest contr...

Page 30: ...quence 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...

Page 31: ...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 32: ...lash 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 i...

Page 33: ...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 34: ...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 35: ...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 36: ...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 37: ...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 38: ...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 39: ...ow 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 probl...

Page 40: ...es 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...

Page 41: ...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 42: ...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 43: ...t 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 perfo...

Page 44: ...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 45: ...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...

Page 46: ...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 devic...

Page 47: ...Inc offers 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 t...

Page 48: ...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 49: ...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 inte...

Page 50: ...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...

Page 51: ...er 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 350...