Clever Choice Auto-Code Pro Owner's Manual

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

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Dec. 2009 Version 1.0

311-4267100-001

MANUAL

OWNER'S

Blood Glucose Monitoring System

Dear CLEVER CHOICE Auto-Code Pro’s System
Owner:

Thank you for purchasing the CLEVER CHOICE Auto-Code Pro
Blood Glucose Monitoring System. This manual provides important
information to help you to use the system properly. Before using this
product, please read the following contents thoroughly 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 CLEVER CHOICE Auto­Code Pro Blood Glucose Monitoring System to easily monitor your
blood glucose levels by yourself anywhere, any time.

If you have other questions regarding this product, please contact
the place of purchase, or call our 24-hour toll free number 1-877­DIABETK (1-877-342-2385).

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

1. Use this device ONLY for the intended use described in this
manual.

2. Do NOT use accessories which are not specied by the manufac­turer.

3. Do NOT use the device if it is not working properly or or if it is
damaged.

4. Do NOT use the equipment in places where aerosol sprays are
being used, or where oxygen is being administered.

5. Do NOT under any circumstances use the device on newborns,
infants, or people who cannot communicate.

6. This device does NOT serve as a cure for any symptoms or
diseases. The data measured is for reference only. Always consult
your doctor to have the results interpreted.

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.

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. Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.

10. Do not use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the proper
operation.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS 5

BEFORE YOU BEGIN 8

Important Information 8

Intended Use 9

Test Principle 9

Contents of System 10

Meter Overview 11

Screen Display 12

Test Strip 13

Setting the Meter 14

THE FOUR MEASURING MODES 18

CONTROL SOLUTION TESTING 19

Performing a Control Solution Test 19

TESTING WITH BLOOD SAMPLE 22

Overview of the Lancing Device 22

Setting up the lancing device 23

Preparing the puncture site 24

Alternative Site Testing 26

Performing a blood glucose test 28

METER MEMORY 31

Reviewing Test Results 31

Reviewing Blood Glucose Day Average Results 32

DOWNLOADING RESULTS ONTO A COMPUTER 34

MAINTENANCE 35

Battery 35

Caring for Your Meter 37

Caring for Your Test Strips 37

Important Control Solution Information 38

SYSTEM TROUBLESHOOTING 39

Result Readings 39

Error Messages 40

Troubleshooting 41

DETAILED INFORMATION 42

Reference values 42

Comparing Meter and Laboratory Results 43

SPECIFICATIONS 45

8

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 im­mediately.

If your blood glucose results are lower or higher than usual, and

you do not have symptoms of illness, rst repeat the test. If you

have symptoms or continue to get results which are higher or
lower than usual, follow the treatment advice of your healthcare
professional.

Use only fresh whole blood samples to test your blood glucose.

Using other substances will lead to inaccurate results.

If you are experiencing symptoms that are inconsistent with your

blood glucose test results and you have followed all the instruc­tions given in this owner’s manual, contact your healthcare profes­sional.

Inaccurate results may occur in severely hypotensive individuals or

patients who are in shock. Readings which are lower than actual
values may occur for individuals in a hyperglycemic-hyperosmolar
state, with or without ketosis. Please consult your healthcare
professional before use.

BEFORE YOU BEGIN

9

Intended Use

This system is intended for use outside the body (in vitro diagnostic
use) by people with diabetes at home and by health care profes­sionals in clinical settings as an aid to monitoring the effectiveness
of diabetes control. It is intended to be used for the quantitative
measurement of glucose (sugar) in fresh whole blood samples (from

the nger, palm, forearm, upper arm, calf and thigh).

It should not be used for the diagnosis of diabetes, or testing on
neonates.

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. Your 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.

10

Contents of System

Your new CLEVER CHOICE Auto-Code Pro system kit includes:

Test strip and control solution are not included in the kit (please
check the contents on your product box). They can be purchased
separately. Please make sure you have those items needed for a
blood glucose test beforehand.

Daily Log Book

Warranty Card

Sterile Lancets

One CR2032 Battery

Meter

Owner’s Manual

Storage case

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
assistance.

NOTE

Quick Start User Guide

11

Meter Overview

Front

Top

Rear

Left Side BackRight Side

DISPLAY SCREEN

BATTERY COMPARTMENT

M BUTTON

Enter the meter memory and silence
a reminder alarm.

TEST STRIP EJECTOR

Eject the used strip by pushing up this
button.

UP BUTTON & DOWN BUT-

TON

Select or change information.

S BUTTON

Enter and conrm the meter settings.

TEST SLOT

Insert test strip here to turn the meter
on for testing.

DATA PORT

Download test results with a cable
connection.

12

Screen Display

Measurement mode

Blood drop symbol

Test strip symbol

Error message

Test result

Date

Time

Day average

Low battery symbol

Memory symbol

Ketone warning

Control solution mode

Measurement unit

Reminder alarms

13

Test Strip

Test results might be wrong if the contact
bar is not fully inserted into the test slot.

Attention!

The front side of the test strip should face
up when inserting the test strip.

Front Back

The CLEVER CHOICE Auto-Code Pro meter should only be
used with CLEVER CHOICE Auto-Code Pro 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 Strip Handle

Hold this part to insert the test strip into the slot.

Conrmation window

Conrm if enough blood has been applied to the absor­bent hole of the test strip.

Absorbent Hole

Apply a drop of blood here and the blood will be drawn
in automatically.

14

Setting the Meter

Before using your meter for the rst 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).

Press and rmly hold

for 3 seconds until the

meter turns on.

1. Setting the date

With the year ashing, press

or until the cor-

rect year appears. Press .

With the month ashing, press

or until the cor-

rect month appears. Press .

With the day ashing, press

or until the correct

day appears. Press .

15

2. Setting the time format

Press and release

or to select the desired time format --- 12h or

24h. Press .

3. Setting the time

With the hour ashing, press

or until the cor-

rect hour appears. Press .

With the minute ashing, press

or until the cor-

rect minute appears. Press .

4. Deleting the Memory

With “dEL” and a blinking “

” symbol on the
display, press and select “no” to keep the results
in memory.