Clever Choice Voice+ Owner's Manual
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Clever Choice Voice+ Owner's Manual

Blood glucose meter
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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
For in vitro diagnostic use only
1-877-DIABETK
1-877-342-2385
Read instructions before use
www.SimpleDiagnostics.com
For self-testing

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  • Page 1: Blood Glucose Meter

    BLOOD GLUCOSE METER Distributed by Simple Diagnostics P.O. Box 128, Williston Park, NY 11596 USA 24-HOUR TOLL-FREE TELEPHONE ASSISTANCE For in vitro diagnostic use only 1-877-DIABETK 1-877-342-2385 Read instructions before use www.SimpleDiagnostics.com For self-testing...
  • Page 3 BLOOD GLUCOSE METER OWNER'S MANUAL June 2011 Versión 1.0...
  • Page 4 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 CLEVER CHOICE Voice+ Blood Glucose Meter to easily monitor your blood glucose levels by yourself anywhere, any time.

  • Page 5: Important Safety Precautions

    IMPORTANT SAFETY PRECAUTIONS READ BEFORE USE The meter and lancing device are for single patient use. Do not share 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 have performed cleaning and disinfection.
  • Page 6 6. This device does NOT serve as a cure for any symptoms or dis- eases. The data measured is for reference only. 7. Before using this device to test blood glucose, read all instructions thoroughly and practice the test. Carry out all the quality control checks as directed.

  • Page 7: Table Of Contents

    TABLE OF CONTENTS BEFORE YOU BEGIN Important Information Intended Use Test Principle Contents of System Meter Overview Display Screen Test Strip Speaking Function Setting the Meter BEFORE TESTING Control Solution Testing Performing a Control Solution Test TESTING WITH BLOOD SAMPLE Overview of the Lancing Device Preparing the Puncture Site Alternative Site Testing...
  • Page 8 MAINTENANCE Battery Caring for Your Meter Caring for Your Test Strips Important Control Solution Information SYSTEM TROUBLESHOOTING Result Readings Error Messages Troubleshooting DETAILED INFORMATION Reference values Comparing Meter and Laboratory Results SPECIFICATIONS...

  • Page 9: Before You Begin

    BEFORE YOU BEGIN Important Information Severe dehydration and excessive water loss may cause readings which are lower than actual values. If you believe you are suffering from severe dehydration, consult a healthcare professional im- mediately. If your blood glucose results are lower or higher than usual, and you do not have any symptoms of illness, first repeat the test.

  • Page 10: Intended Use

    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.

  • Page 11: Contents Of System

    Contents of System Your new CLEVER CHOICE Voice+ Blood Glucose Meter kit includes: Meter Daily Log Book Warranty Card Owner’s Manual Protective Wallet 2 x 1.5V AAA alkaline batteries Quick Start User Guide Quick Start User Guide Test strips, control solution, or sterile lancets may be purchased separately.

  • Page 12: Meter Overview

    Meter Overview Front Back Display Screen Button Test Strip Ejector Enter and confirm the meter settings. Eject the used strip by pushing up this button. Earphone Port Test Slot Insert earphones to listen the voice messages. Insert test strip here to turn the Data Port meter on for testing.

  • Page 13: Display Screen

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

  • Page 14: Test Strip

    The front side of the test strip should face up when inserting the test strip. Frente Reverso NOTE The CLEVER CHOICE Voice+ Blood Glucose Meter should only be used with CLEVER CHOICE Voice+ Test Strips. Using other test strips with this meter can produce inaccurate results.

  • Page 15: Speaking Function

    Speaking Function CLEVER CHOICE Voice+ Blood Glucose Meter “speaks” aloud with step by step instructions to guide you through the process of setting up your meter and blood glucose testing. The following table tells you when and what the meter “speaks”.
  • Page 16 1. The (first/second/third/fourth) alarm is disabled/enabled. 2. The (first/second/third/fourth) Setting the alarm alarm hour is (number) AM/PM. 3. The (first/second/third/fourth) alarm minutes are (number). 1. Today’s date is (week day) (month) (day), (year). 2.The time is (hour minute) AM/ 3.Blood glucose unit is milligrams per deciliter.
  • Page 17 1. Test strip inserted. Insert test strip 2.Today’s date is (week day) (month) (day), (year). 3.The time is (hour minute) PM/ When the meter is ready to test. (symbol appears on display) 4.Please apply blood onto the test strip. After sample is applied onto Now testing.
  • Page 18 1. Thank you for using this product. 2. Today’s date is (week day) (month) (day), (year). 3. The time is (hour minute) AM/ Reading the Average of Blood Glucose Results 4. Press M key for memory recall mode. 5. The (number) day blood glucose average is (number) mil- ligrams per deciliter for (number) records.

  • Page 19: Setting The Meter

    Setting the Meter Before using your meter for the first time or if you change the meter battery, you should check and update these settings. Make sure you complete the steps below and have your desired settings saved. Entering the Setting Mode Start with the meter off (no test strip inserted).
  • Page 20 3. Setting the date With the year flashing, press until the cor- rect year appears. Press With the month flashing, press until the cor- rect month appears. Press With the day flashing, press until the correct day appears. Press 4. Setting the time With the hour flashing, press until the cor- rect hour appears.
  • Page 21 5. Deleting the memory With “dEL” and a flashing “ ” symbol on the display, press keep the results in memory. To delete all the results, press twice. “ ” and “ ” are displayed on the meter, which indicates that all data stored is deleted. 6.
  • Page 22 If you do not want to set an alarm, press and select “OFF” to skip this step. Setup the remaining three reminder alarms by following instructions above. Press to turn off the meter. The meter repeats all your settings before shutdown. Congratulations! You have completed all settings! If you want to turn off an alarm, find the alarm number by pressing Set in the setting mode, press...

  • Page 23: Before Testing

    BEFORE TESTING Control Solution Testing CLEVER CHOICE Control Solution contains a known amount of glucose that reacts with test strips and is used to ensure your meter and test strips are working together correctly. Do a control solution test when:...

  • Page 24: Performing A Control Solution Test

    Performing a Control Solution Test 1. Insert the test strip to turn on the meter Insert the test strip into the meter. Wait for the meter to display the test strip and blood drop symbols. 2. Press to mark this test as a control solution test With “CTL”...
  • Page 25 3. Apply Control Solution Shake the control solution vial thor- oughly before use. Squeeze out a drop and wipe it off, then squeeze out another drop and place it on the tip of the vial cap. Hold the meter to move the absorbent hole of the test strip to touch the drop.
  • Page 26 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. Contact the local customer service or place of purchase for help.

  • Page 27: Testing With Blood Sample

    TESTING WITH BLOOD SAMPLE Overview of the Lancing Device Please refer to the manufacturer’s instructions for the lancing device to collect a blood sample. WARNING To reduce the chance of infection: Never share a lancet or the lancing device. Always use a new, sterile lancet. Lancets are for single use only.

  • Page 28: Preparing The Puncture Site

    Preparing the Puncture Site Stimulating blood perfusion by rubbing the puncture site before blood extraction has a significant influence on the glucose value obtained. Blood from a site that has not been rubbed exhibits a measurably different glucose concentration than blood from the finger. When the puncture site was rubbed prior to blood extraction, the difference was significantly reduced.
  • Page 29 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 click indicates that the puncture is complete. Blood from sites other than the fingertip Replace the lancing device cap with the clear cap for AST.

  • Page 30: Alternative Site Testing

    Alternative Site Testing Important: There are limitations with AST (Alternative Site Testing). The alternative site testing of the system can be used in only during steady-state blood glucose conditions. Please consult your health care professional before you perform AST. Alternative site testing (AST) should not be used to calibrate continuous glucose monitoring systems (CGMs).
  • Page 31 When to use AST? Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites. Thus, when testing blood glucose during or immediately after a meal, physical exercise, or any other event, take a blood sample from your finger only.

  • Page 32: Performing A Blood Glucose Test

    Performing a Blood Glucose Test 1. Insert the test strip to turn on the meter Wait for the meter to display the test strip and blood drop symbols. 2. Obtaining a blood sample Use the pre-set lancing device to puncture the desired site.
  • Page 33 NOTE Do not press the punctured site against the test strip or try to smear the blood. If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and reinsert the test strip to start a new test.
  • Page 34 5. Eject the used test strip and remove the lancet To eject the test strip, point the strip at a disposal container for sharp items. The meter will switch itself off automatically after the test strip is ejected. Always follow the instructions in the lancing device insert when removing the lancet.

  • Page 35: Meter Memory

    METER MEMORY The meter stores the 450 most recent blood glucose test results along with respective dates and times in its memory. To enter the meter memory, start with the meter switched off. Reviewing Test Results 1. Press and release will appear on the display.

  • Page 36: Reviewing Blood Glucose Day Average Results

    3. Exit the meter memory After the last test results, keep pressing and the meter will be turned off. Reviewing Blood Glucose Day Average Results 1. Press and release When appears on the display, keep pressing for 3 seconds until the flashing appears.
  • Page 37 3. Exit the meter memory Keep pressing the and the meter will turn off after displaying the last test result. NOTE Any time you wish to exit the memory, keep pressing for 5 seconds or leave it without any action for 3 minutes. The meter will switch off automatically.

  • Page 38: Downloading Results Onto A Computer

    Downloading Results onto a Computer You can use the meter and download your test results to view on your personal computer. Please download the software from the Simple Diagnostics website at http://www.SimpleDiagnostics.com and install on your computer first. Follow instructions below to trans- mit the data.

  • Page 39: Maintenance

    MAINTENANCE Battery Your meter comes with two1.5V AAA size alkaline batteries. Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low. 1. The symbol appears along with display messages: The meter is functional and the result remains accurate, but it is time to change the bat- teries.
  • Page 40 NOTE Replacing the batteries does not affect the test results stored in the memory. As with all small batteries, these batteries should 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 for an extended period (i.e., 3 months or more).

  • Page 41: Caring For Your Meter

    We recommend for meter cleaning and disinfection you should use the disinfecting wipe/towelette from below. The following product with isopropyl alcohol as the active ingredient has been shown to be safe for use with the CLEVER CHOICE Voice+ meter. Micro-Kill+™ (Micro-Kill Plus™) by Medline (EPA Reg. No. 59894- 10-37549) To obtain disinfecting wipes and other information, please contact Medline at 1-800-MEDLINE (1-800-633-5463) or visit www.medline.
  • Page 42 Disinfecting Procedures 1. Take out one disinfecting wipe from the package and squeeze out any excess liquid in order to prevent damage to the meter. 2. Wipe all meter’s exterior surface display and buttons. Hold the meter with the test strip slot pointing down and wipe the area around the test slot but be careful not to allow excess liquid to get inside.
  • Page 43 This device has been validated to withstand up to 5,000 cleaning and disinfection cycles using the recommended disinfecting wipe/ towelette. The tested number of cycles is estimated by a minimum of 1 cleaning and disinfection per week, plus any additional cleanings over 5 years, the expected life of the device.
  • Page 44 NOTE Do NOT clean and disinfect the meter while performing tests. If the meter is being operated by a second person, the meter and lancing device should be decontaminated prior to use by the second person. Do NOT allow cleaning and disinfecting solution to get in the test slot, battery compartment, or strip-ejection button.

  • Page 45: Caring For Your Test Strips

    Caring for Your Test Strips Storage conditions: 39.2°F to 104°F (4°C to 40°C), below 85% relative humidity. Do not freeze. Store your test strips in their original vial only. Do not transfer to another container. Store test strip packages in a cool dry place. Keep away from direct sunlight and heat.

  • Page 46: Important Control Solution Information

    Important Control Solution Information Use only CLEVER CHOICE 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 control solution vial and discard the remaining solution after 3 months.

  • Page 47: System Troubleshooting

    SYSTEM TROUBLESHOOTING If you follow the recommended action but the problem persists, or error messages other than the ones below appear, please call your local customer service. Do not attempt to repair yourself and never try to disassemble the meter under any circumstances. Result Readings MESSAGE WHAT IT MEANS...

  • Page 48: Error Messages

    Error Messages WHAT DOES WHAT IT MESSAGE WHAT TO DO METER SAY? MEANS Appears when the batteries Replace the Battery is dead. cannot provide batteries im- Please replace. enough power mediately. for a test. Please replace. Appears when a used test Strip has been Repeat with a strip is in-...
  • Page 49 WHAT DOES WHAT IT MESSAGE WHAT TO DO METER SAY? MEANS Remove the Please ensure strip after ap- proper op- Re-test with a plying blood to eration then try new test strip. the absorbent again. hole. Repeat the test with a new test strip.

  • Page 50: Troubleshooting

    Troubleshooting 1. If the meter does not display a message after inserting a test strip: POSSIBLE CAUSE WHAT TO DO Batteries exhausted. Replace the batteries. Test strip inserted upside down Insert the test strip with contact or incompletely. bars end first and facing up. Please contact customer Defective meter or test strips.
  • Page 51 3. If the control solution testing result is out of range. POSSIBLE CAUSE WHAT TO DO Read instructions thoroughly Error in performing the test. and repeat the test again. Shake the control solution Control solution vial was poorly vigorously and repeat the test shaken.

  • Page 52: Detailed Information

    DETAILED INFORMATION Reference values Blood glucose monitoring plays an important role in diabetes control. A long-term study showed that maintaining blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%* . The results provided by this system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.

  • Page 53: Comparing Meter And Laboratory Results

    Comparing Meter and Laboratory Results The meter provides you with whole blood equivalent results. The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results may be af- fected by factors and conditions that do not affect laboratory results in the same way.
  • Page 54 You may still have a variation from the result because blood glucose levels can change significantly over short periods of time, especially if you have recently eaten, exercised, taken medication or expe- rienced stress* . 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 for a lab test*...

  • Page 55: Specifications

    SPECIFICATIONS Model No.: TD-4248 Dimension & Weight: 93.9 (L) x 57.2 (W) x 20 (H) mm, 80.6 g Power Source: two 1.5V AAA alkaline batteries Display: LCD Memory: 450 measurement results with respective date and time External output: RS232 PC interface Auto electrode insertion detection Auto sample loading detection Auto reaction time count-down...
  • Page 56 NOTE...

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