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Summary of Contents for TD-4116

Page 1: ...Blood Glucose Monitoring System Owner s Manual...

Page 2: ......

Page 3: ...nt of glucose sugar in fresh capillary whole blood from the finger and alternative sites palm forearm and upper arm This blood glucose monitoring system is intended to be used by a single person and s...

Page 4: ...tick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 2010 http wayback archive it org 7993 20170111013014 http www fda gov MedicalDevices Safety...

Page 5: ...ty control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets and vial caps are choking hazards 9 D...

Page 6: ...re Site 10 Performing a Blood Glucose Test 12 Alternative Site Testing 14 METER MEMORY 16 Reviewing Test Results 16 Reviewing Blood Glucose Day Average Results 16 DOWNLADING RESULTS TO A COMPUTER 17 D...

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Page 8: ...w the treatment advice of your healthcare professional y Use only fresh whole blood samples to test your blood glucose Using other substances will lead to inaccurate results y If you are experiencing...

Page 9: ...althcare or assisted use settings such as hospitals physician offices or long term care facilities because it has not been cleared by FDA for use in these settings including for routine assisted testi...

Page 10: ...let Quick Start Guide Blood Glucose Test Strips Lancing Device Sterile Lancets 1 x 1 5 V AAA alkaline batteries Test strips c control solutions d sterile lancets e or lancing device f are not included...

Page 11: ...rt test strip here to turn the meter on for testing Display Screen M Button M Enter the meter memory and mute a reminder alarm Data Port Transfer test results with a cable connection Battery Compartme...

Page 12: ...Test strip symbol Blood drop symbol Test Strip NOTE The PHWHQH 7 Blood Glucose Meter should only be used with PHWHQH 7 Blood Glucose Test Strips Using other test strips with this meter can produce in...

Page 13: ...EAR MONTH DAY flashing in sequence press M button M until the correct year month day appears Press S Setting the time format Press M to select the desired time format 12h or 24h Press S Setting the ti...

Page 14: ...egin testing if you ignore it the meter will beep for 2 minutes then switch off Congratulations You have completed all settings NOTE y These parameters can ONLY be changed in the setting mode y If the...

Page 15: ...test results are not consistent with how you feel or if you think the results are not accurate y Practicing the testing process y You have dropped or think you may have damaged the meter Performing a...

Page 16: ...h the drop Once the confirmation window fills completely the meter will begin counting down To avoid contaminating the control solution do not directly apply control solution onto a strip Read and Com...

Page 17: ...ection y If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be decontaminated prior to use by the second person Shari...

Page 18: ...s tip firmly against the lower side of your fingertip Press the release button to prick your finger then a click indicates that the puncture is complete Blood from sites other than the fingertip i Rep...

Page 19: ...ure the desired site Wipe off the first appeared drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood The volume of blood sample must be at least 0...

Page 20: ...ard the used test strip and retest with a new one y If you have trouble filling the confirmation window please contact your health care professional or the local customer service for assistance Read Y...

Page 21: ...the Cleaning and Disinfection section Alternative Site Testing When you are doing alternative site testing only samples from the palm upper arm and forearm should be used IMPORTANT There are limitati...

Page 22: ...er event take a blood sample from your finger only We strongly recommend that you perform AST ONLY at the following times y In a pre meal or fasting state more than 2 hours since last meal y Two hours...

Page 23: ...urned off Reviewing Blood Glucose Day Average Results Press and release M When appears on the display keep pressing M for 3 seconds until the flashing DAY AVG appears Release M and then your 7 day ave...

Page 24: ...h Care Software System please visit the metenecare website at http metene com Connecting to a personal computer Connect the cable to the USB port on your computer With the meter switched off connect t...

Page 25: ...To replace the batteries make sure that the meter is turned off m Press the edge of the battery cover and lift it up to remove Remove the old batteries and replace with one 1 5 V AAA size alkaline bat...

Page 26: ...e g food debris grease dust while disinfection 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 di...

Page 27: ...r test strips This device has been validated to withstand up to 10950 cleaning and disinfection cycles using the recommended disinfecting wipe towelette The tested number of cycles is estimated by 10...

Page 28: ...ide and damage the electronic components or circuitry Caring for Your Test Strips y Storage conditions 39 2 F 104 F 4 C 40 C relative humidity between 10 85 Do not freeze y Store your test strips in t...

Page 29: ...d discard the remaining solution after 3 months y It is recommended that the control solution test be done at room temperature 68 F 77 F 20 C 25 C Make sure your control solution meter and test strips...

Page 30: ...r than 240 mg dL 13 3 mmol L This indicates the possibility of ketone accumulation for type 1 diabetes Please seek medical assistance immediately The User s blood glucose level has exceeded 240 mg dL...

Page 31: ...sociation Standards of Medical Care in Diabetes 2018 Jan 41 Supplement 1 S1 S2 Please consult your doctor to determine a target range that works best for you Comparing Meter and Laboratory Results The...

Page 32: ...ion 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 vein venous sample used f...

Page 33: ...battery immediately E U Appears when a used test strip is inserted Repeat the test with a new test strip E E Problem in operation Repeat the test with a new test strip If the meter still does not wor...

Page 34: ...mple only when flashing appears on the display Defective meter Please contact customer services If the control solution testing result is out of range POSSIBLE CAUSE WHAT TO DO Error in performing the...

Page 35: ...inutes without action Temperature Warning Operating Condition 50 F 104 F 10 C 40 C 10 to 85 R H non condensing Meter Storage Transportation Conditions 4 F 140 F 20 C 60 C below 95 R H Strip Storage Tr...

Page 36: ...7 Currier Road Suite O Walnut CA 91789 USA Toll Free 12133786121 7 00 am 6 00 pm PST Mon Fri For assistance outside of these hours please contact your healthcare professional www PHWHQH com For Self t...

Page 37: ...DXWRPDWLFDOO VDYHG LQ WKH PHWHU 7XUQ LW RII E UHPRYLQJ WKH WHVW VWULS LVSRVH RI XVHG WHVW VWULSV DFFRUGLQJ WR RXU KHDOWKFDUH SURYLGHU V LQVWUXFWLRQV PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING A...

Page 38: ...H WKH GHYLFH XQGHU ZDWHU R 127 SODFH WKH GHYLFH LQ D GLVKZDVKHU RU XVH GHWHUJHQWV Before collecting a drop of blood DVK DQG GU RXU KDQGV EHIRUH RX VWDUW 6HOHFW WKH SXQFWXUH VLWH DW WKH ILQJHUWLS 5XE W...

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