TULA HEALTH THG001, Owner'S Manual

Page 1: ...Part no 311 4206XXX XXX Product name Tula Health THG001 Spec L148 W105mm 80P 4C 48 Writer Peter Derrick Color K 100...

Page 2: ...THG001 Blood Glucose Monitoring System Owner s Manual...

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Page 4: ...e Tula Health THG001 Blood Glucose Monitoring System consists of the Tula Health THG001 meter Tula Health THG001 test strips and the Tula Health THG001 mobile application as the display component of t...

Page 5: ...s Initial Communication 2010 http wayback archive it org 7993 20170111013014 http www fda gov MedicalDevices Safety AlertsandNotices ucm224025 htm 2 CDC Clinical Reminder Use of Fingerstick Devices on...

Page 6: ...ng static discharges that may produce incorrect results 9 Do NOT use this instrument in close proximity to sources of strong electromagnetic radiation ex an alternator as these may interfere with the...

Page 7: ...12 Performing a Control Solution Check 13 TESTING WITH BLOOD SAMPLE 15 Preparing the Lancing Device for Blood Testing 15 Preparing the Puncture Site 15 Performing a Blood Test 17 METER HISTORY 20 Rev...

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Page 9: ...f your blood glucose results are lower or higher than expected and you do not have any symptoms of illness first repeat the test If you have symptoms or continue to get results which are higher or low...

Page 10: ...recharge 2 Cellular Connection and Battery Level Indicator 3 Display Window and Touchscreen The touchscreen allows users to interact with what is displayed directly by the finger 4 Volume Button 5 Pow...

Page 11: ...a Health THG001 system kit includes 1 Meter 2 Owner s Manual 3 Protective Wallet 4 Micro USB cable 5 Adapter NOTE If any items are missing from your kit or opened prior to use please contact Tula Heal...

Page 12: ...layed The meter features 3 main functions measuring check memory history and setting which are shown on the main page Other icons on the Main Page are introduced as below 1 Cellular Signal 2 Battery C...

Page 13: ...he test strip into the slot 4 Contact Bars Insert this end of the test strip into the meter Push it in firmly until it will go no further ATTENTION The front side of test strip should face up when ins...

Page 14: ...ith the system off Press the power button for 1 second to activate the meter The meter displays the Tula Health logo then a welcome page Continuing past the welcome page at the main page there are 6 f...

Page 15: ...lecommunication airplane mode On apply as necessary Units 1 Tap on to set the measuring unit mg dL or mmol L 2 Tap on the preferred one and then to save and exit NOTE The airplane mode allows users to...

Page 16: ...elect the appropriate category for the reminder 4 Select the appropriate time for the reminder 4 Select whether to repeat the reminder and then to save and exit Language 1 Tap on to set the displayed...

Page 17: ...h will vibrate Tap to exit Brightness 1 Tap on to set the brightness 2 Slide the bar to adjust the brightness 3 Tap to save and exit About 1 Tap on to view device info 2 Tap to exit Congratulations Yo...

Page 18: ...result to the server Tula will contact you if the uploaded result is atypical 2 Talk Whenever the button on the home screen is pressed Appears when a call comes in Tap on to take or to reject The fol...

Page 19: ...d prior to your receipt of the meter If not please contact Tula Health at 855 352 7884 for assistance The connection quality may vary from each service provider The calling and data transmission featu...

Page 20: ...s are not consistent with how you feel l if you think the results are not accurate l to practice the testing process or l if you have dropped or think you may have damaged the meter Test strips contro...

Page 21: ...er the measuring page Tap and wait for the meter to display the test strip symbol 3 Apply control solution Shake the control solution vial thoroughly before use Squeeze out a drop and wipe it off then...

Page 22: ...ution test Out of range Results If you continue to have test results fall outside the range printed on the test strip vial the meter and strips may not be working properly Do NOT test your blood Conta...

Page 23: ...d be decontaminated see MAINTENANCE section prior to use by the second person l If patient is being assisted with glucose meter testing the assistant should wear gloves throughout Additionally the ass...

Page 24: ...on moistened with 70 alcohol and let it air dry l Fingertip testing Press the lancing device s tip firmly against the lower side of your fingertip Press the release button to prick your finger then a...

Page 25: ...ctivate the meter At the main page tap on to start the measurement 2 Perform the blood glucose test as directed on the display 3 Obtaining a blood sample Use the pre set lancing device to puncture the...

Page 26: ...before your finger leaves the absorbent hole or meter to prevent inaccurate glucose results 5 Wait a few seconds for the measurement to process When the page of measuring mode appears choose the mode...

Page 27: ...of blood has moved away Discard the used test strip and retest with a new one l If you have trouble filling the confirmation window please contact your health care professional or the local customer s...

Page 28: ...tory feature Tap on to enter the history feature 3 Review Records Tap on range drop down and select the desired range The average along with the percent of checks in range are displayed at the top The...

Page 29: ...Battery Recharging the Battery Use an AC power adapter Plug the meter into a wall outlet to initiate the charging process Battery Charging Indicator Refer to the battery icon on the upper right for ba...

Page 30: ...infection is the process of killing germs e g bacteria and viruses When to clean and disinfect the meter Clean the meter when you see any dirt on it You should disinfect the meter at least once a week...

Page 31: ...ses vertically and three passes horizontally with a folded disinfecting towelette Hold the meter with the test strip slot pointing down and wipe the area around the test slot but be careful not to all...

Page 32: ...or abrasions on meter are higher thanacceptable Please contact the customer service for a replacement meter if any of the signs of deterioration are noticed NOTE Do NOT clean and disinfect the meter w...

Page 33: ...from the vial immediately close the vial cap tightly Touch the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Do not use test strips beyond the ex...

Page 34: ...ol Solution Information Use only Tula Health control solutions with your meter Do not use the control solution beyond the expiration date or 3 months after first opening Write the opening date on the...

Page 35: ...Insert New Strip Appears when a used test strip is applied Repeat the test with a new test strip Contact the service center if the problem persists Not Enough Blood on Test Strip Appears when the amo...

Page 36: ...perature Too Low Appears when ambient temperature is above or below system operation range System operation range is 50 F to 104 F 10 C to 40 C Repeat the test after the meter and test strip are in th...

Page 37: ...w test strip Defective meter Please contact customer services 3 If the control solution testing result is out of range POSSIBLE CAUSE WHAT TO DO Error in performing the test Read instructions thorough...

Page 38: ...L 1 American Diabetes Association Classification and Diagnosis of Diabetes Standards of Medical Care in Diabetes 2020 Jan 43 Supplement 1 S14 S31 https doi org 10 2337 dc20 S002 Comparing Meter and L...

Page 39: ...exercised taken medication or experienced stress 2 In addition if you have eaten recently the blood glucose level from a finger prick can be up to 70 mg dL 3 9 mmol L higher than blood drawn from a v...

Page 40: ...to 140 F 20 C to 60 C 10 to 93 R H Strip Storage Transportation Condition 35 6 F to 86 F 2 C to 30 C 10 to 85 R H non condensing Measurement Units mg dL or mmol L Measurement Range 20 to 600mg dL 1 1...

Page 41: ...quipment 1 This Transmitter must not be co located or operating in conjunction with any other antenna or transmitter For only one antenna 2 This equipment complies with FCC RF radiation exposure limit...

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Page 45: ...Tula Health Inc 280 North Kays Drive Suite 200 Kaysville UT 84037 Toll Free 1 855 352 7884 Hours of Operation 24 hours 7 days week For self testing Read instructions before use...