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Intended Use

The

CLEVER CHOICE Voice+

Blood Glucose Monitoring System is

intended for use in the quantitative measurement of glucose in fresh

capillary whole blood from the finger and the following alternative

sites: the palm, the forearm, the upper-arm, the calf and the thigh. It

is intended for use by people with diabetes mellitus at home as an

aid in monitoring the effectiveness of diabetes control program. It is

not intended for the diagnosis of or screening for diabetes mellitus,

and is not intended for use on neonates. The alternative site 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 be shared.

This system contains a speaking functionality which provides step by

step instructions to aid visually impaired persons.

Test Principle

Your system measures the amount of sugar (glucose) in whole

blood. The glucose testing is based on the measurement of electrical

current generated by the reaction of glucose with the reagent of the

strip. The meter measures the current, calculates the blood glucose

level, and displays the result. The strength of the current produced

by the reaction depends on the amount of glucose in the blood

sample.

Содержание Voice+

Страница 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...

Страница 2: ......

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 56: ...56 NOTE...

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