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BLOOD GLUCOSE METER

Distributed by

Simple Diagnostics

P.O. Box 128, Williston Park, NY 11596 USA

24-HOUR TOLL-FREE TELEPHONE ASSISTANCE

1-877-DIABETK 1-877-342-2385

www.SimpleDiagnostics.com

For in vitro diagnostic use only

Read instructions before use

For self-testing

nual

ner’s

Summary of Contents for Voice+

Page 1: ...Diagnostics P O Box 128 Williston Park NY 11596 USA 24 HOUR TOLL FREE TELEPHONE ASSISTANCE 1 877 DIABETK 1 877 342 2385 www SimpleDiagnostics com For in vitro diagnostic use only Read instructions be...

Page 2: ......

Page 3: ...June 2011 Versi n 1 0 MANUAL OWNER S BLOOD GLUCOSE METER...

Page 4: ...oroughly and carefully Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabetes Due to its compact size and easy operation you can use the CLEV...

Page 5: ...hare them with anyone including other family members Do not use on multiple patients All parts of the kit are considered biohazardous and can potentially transmit infectious diseases even after you ha...

Page 6: ...thoroughly and practice the test Carry out all the quality control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries t...

Page 7: ...Setting the Meter 19 BEFORE TESTING 23 Control Solution Testing 23 Performing a Control Solution Test 24 TESTING WITH BLOOD SAMPLE 27 Overview of the Lancing Device 27 Preparing the Puncture Site 28 A...

Page 8: ...ing for Your Test Strips 45 Important Control Solution Information 46 SYSTEM TROUBLESHOOTING 47 Result Readings 47 Error Messages 48 Troubleshooting 50 DETAILED INFORMATION 52 Reference values 52 Comp...

Page 9: ...se only fresh whole blood samples to test your blood glucose Using other substances will lead to incorrect results If you are experiencing symptoms that are inconsistent with your blood glucose test r...

Page 10: ...te testing in this system can be used only during steady state blood glucose conditions The CLEVER CHOICE Voice Blood Glucose Monitoring System is intended to be used by a single person and should not...

Page 11: ...Protective Wallet Quick Start User Guide Quick Start User Guide If any items are missing from your kit or opened prior to use please contact local customer services or place of purchase for assistanc...

Page 12: ...Button Down Button Select or change information Button Enter the meter memory and silence a reminder alarm Button Enter and confirm the meter settings Earphone Port Insert earphones to listen the voic...

Page 13: ...3 Display Screen Low battery symbol Test strip symbol Blood drop symbol Volume symbol Test result Memory symbol Date Time Ketone warning Day average Measurement unit Control solution mode Error messag...

Page 14: ...d only be used with CLEVER CHOICE Voice Test Strips Using other test strips with this meter can produce inaccurate results NOTE Contact Bars Insert this end of the test strip into the test slot Test S...

Page 15: ...the language You are now in setting mode Thank you for using this product Setting the voice volume Voice volume is number Setting the year The Year is number Setting the month The month is month Sett...

Page 16: ...ird fourth alarm is disabled enabled 2 The first second third fourth alarm hour is number AM PM 3 The first second third fourth alarm minutes are number At the end of the meter setting 1 Today s date...

Page 17: ...iliter When the test result is 20 mg dL Your blood glucose is less than 20 milligrams per deciliter When the test result is 600 mg dL Your blood glucose is over 600 milligrams per deciliter When selec...

Page 18: ...all mode 5 The number day blood glucose average is number mil ligrams per deciliter for number records If no results stored in memory No memory record available Downloading results from your meter ont...

Page 19: ...e meter turns on 1 Choosing a Language Press or to select L1 L2 The default language for the meter is L1 which is English L2 is Spanish To confirm your selection press 2 Setting the speaking volume Th...

Page 20: ...the month flashing press or until the cor rect month appears Press With the day flashing press or until the correct day appears Press 4 Setting the time With the hour flashing press or until the cor r...

Page 21: ...stored is deleted 6 Setting the reminder alarm You may set up the reminder alarm The meter displays OFF or On with press or to turn on or turn off to set the reminder alarm Press or to select On then...

Page 22: ...turn on You can press to silence the alarm and insert a test strip to begin testing If you do not press the meter will beep for 2 minutes then switch off If you do not want to test at this time press...

Page 23: ...ou first receive the meter at least once a week to routinely check the meter and test strips you begin using a new vial of test strips you suspect the meter or test strips are not working properly you...

Page 24: ...t When doing the control solution test you have to mark it so that the test result will not be stored in the memory Failure to do so will mix up the blood glucose test results with the control solutio...

Page 25: ...nfirmation window fills completely the meter will begin counting down To avoid contaminating the control solution do not directly apply control solution onto a strip 4 Read and Compare the Result Afte...

Page 26: ...e working properly Do NOT test your blood Contact the local customer service or place of purchase for help The control solution range printed on the test strip vial is for control solution use only It...

Page 27: ...t infection For more information please refer to the Cleaning and Disinfection section If the meter is being operated by a second person who is providing testing assistance to the user the meter and l...

Page 28: ...or to blood extraction the difference was significantly reduced Please follow the suggestions below before obtaining a drop of blood Wash and dry your hands before starting Select the puncture site ei...

Page 29: ...r AST Pull the cock ing control back until it clicks When lancing the forearm upper arm hand thigh or calf avoid lancing the areas with obvious veins because of exces sive bleeding Choose a different...

Page 30: ...ts from alternative site testing should not be used in insulin dose calculations What is AST Alternative site testing AST means that people use parts of the body other than the fingertips to check the...

Page 31: ...any other event take a blood sample from your finger only We strongly recommend that you perform AST ONLY at the following times In a pre meal or fasting state more than 2 hours since the last meal Tw...

Page 32: ...card the first drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at l...

Page 33: ...strip within 3 minutes the meter will automatically turn off You must remove and reinsert the test strip to start a new test The confirmation window should be filled with blood before the meter begin...

Page 34: ...est strips to avoid contamination For more information please refer to the Cleaning and Disinfec tion section WARNING 5 Eject the used test strip and remove the lancet To eject the test strip point th...

Page 35: ...tive dates and times in its memory To enter the meter memory start with the meter switched off 1 Press and release will appear on the display Press again and the first reading you see is the last bloo...

Page 36: ...off 2 Press or to review 14 21 28 60 and 90 day average results stored in memory Reviewing Blood Glucose Day Average Results 1 Press and release When appears on the display keep pressing for 3 seconds...

Page 37: ...y keep pressing for 5 seconds or leave it without any action for 3 minutes The meter will switch off automatically Control solution results are NOT included in the day average If using the meter for t...

Page 38: ...To install the Health Care system software on your computer please follow the instructions given on the screen 2 Connecting to a personal com puter Connect the meter to a USB port on your computer wit...

Page 39: ...to do a test Please change the batteries immediately Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low Replacing the Battery To repl...

Page 40: ...be kept away from small children If swallowed promptly seek medical as sistance Batteries might leak chemicals if unused for a long time Re move the batteries if you are not going to use the device fo...

Page 41: ...to clean and disinfect the meter The meter must be cleaned prior to the disinfection Use one disinfecting wipe to clean exposed surfaces of the meter thoroughly and remove any visible dirt or blood or...

Page 42: ...the port and damage the electrical components inside the meter Keep meter wet with disin fection solution contained in the wipe for a minimum of 2 minutes for Micro Kill wipes Follow the instructions...

Page 43: ...disinfection cycles or the warranty period which ever comes first Stop using the meter if you see any signs of deterioration For example meter can not be turned on LCD display cracks or becomes cloudy...

Page 44: ...e test strip slot wipe it away with a corner of tissue Always dry the meter thoroughly before using it Do not spray the meter directly with cleaning solutions espe cially those containing water i e so...

Page 45: ...htly Touch the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Write the opening date on the vial label when you first opened it Discard remaining t...

Page 46: ...ter 3 months It is recommended that the control solution test be done at room temperature 68 F to77 F 20 C to 25 C Make sure your control solution meter and test strips are at this specified temperatu...

Page 47: ...ars when your result is below measurement limit which is less than 20 mg dL 1 1 mmol L This symbol indicates hypoglycemia low blood glucose You should seek medical assistance immediately Appears when...

Page 48: ...ears when a used test strip is in serted Please replace Repeat with a new test strip The room temperature is out of range Thus unable to measure Appears when ambient temperature is below system operat...

Page 49: ...lying blood to the absorbent hole Re test with a new test strip Meter malfunc tion Please contact local distributor Problem with the meter Repeat the test with a new test strip If the meter still does...

Page 50: ...bars end first and facing up Defective meter or test strips Please contact customer services POSSIBLE CAUSE WHAT TO DO Insufficient blood sample Repeat the test using a new test strip with larger volu...

Page 51: ...Shake the control solution vigorously and repeat the test again Expired or contaminated control solution Check the expiry date of the control solution Control solution that is too warm or too cold Con...

Page 52: ...djust your treatment plan to gain better control of your diabetes Time of day Normal plasma glucose range for peo ple without diabetes mg dL Fasting and before meal Less than 100 mg dL 5 6 mmol L 2 ho...

Page 53: ...tween meter and laboratory results follow the guidelines below Before going to the lab Perform a control solution test to make sure that the meter is work ing properly Fast for at least eight hours be...

Page 54: ...pecially if you have recently eaten exercised taken medication or expe rienced 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 mmo...

Page 55: ...h off after 3 minutes without action Temperature Warning Operating Condition 50 F to 104 F 10 C to 40 C below 85 R H non condensing Storage Transportation Conditions 4 F to 140 F 20 C to 60 C below 95...

Page 56: ...56 NOTE...

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