Arkray Glucocard Vital Bedienerhandbuch

User

Instruction

Manual

INTRODUCTION ....................................5

Intended Use ....................................5

Important Information.............................6

The GLUCOCARD®Vital™ System...................7

GETTING TO KNOW THE GLUCOCARD®VITAL™ SYSTEM....8

METER SET UP....................................10

Setting the Time and Date .......................10

DISPLAY SCREEN MESSAGES .......................14

METER MEMORY .................................19

Marking Results in the Memory ....................19

Recalling Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

CARING FOR YOUR GLUCOCARD®VITAL™ METER.....24

Cleaning the Meter ..............................24

Storage ........................................24

Changing the Battery ............................25

THE LANCING DEVICE ............................27

Inserting a Lancet ...............................27

Obtaining a Drop of Blood .......................29

TABLE OF CONTENTS

CAUTION:

Before using any product to test your blood sugar

(blood glucose), read all instructions and practice

the test. Do all quality control checks as directed

and consult with a diabetes healthcare professional.

These recommendations apply to all blood glucose

monitoring systems and are supported by the

American Association of Diabetes Educators, the

American Diabetes Association, the U.S. Food

and Drug Administration, and the Health Industry

Manufacturers Association.

TESTING WITH GLUCOCARD®VITAL™ TEST STRIPS . . . . . . . .31

Important Test Strip Information . . . . . . . . . . . . . . . . . . . .31

GLUCOCARD®Vital™ Test Strips . . . . . . . . . . . . . . . . . . .32

PERFORMING A BLOOD GLUCOSE TEST ...............33

ALTERNATE SITE TESTING (AST) . . . . . . . . . . . . . . . . . . . . . .37

Important Information About

Alternate Site Testing (AST) .....................37

Preparing to Test your Blood Glucose

From an Alternate Site.........................38

Performing a blood glucose test

From an Alternate Site.........................39

USING ASSURE®DOSE CONTROL SOLUTION . . . . . . . . . .43

Performing a Control Solution Test . . . . . . . . . . . . . . . . . .45

Comparing Control Solution Results .................48

Comparing Meter and Laboratory Results . . . . . . . . . . .49

UNDERSTANDING TEST RESULTS ......................50

Expected blood glucose readings . . . . . . . . . . . . . . . . 51

High blood glucose readings..................... 51

Low blood glucose readings ..................... 52

SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

WARNINGS, PRECAUTIONS, & LIMITATIONS..............55

WARRANTY ...................................... 56

Thank you for choosing the GLUCOCARD®Vital™ Blood

Glucose Monitoring System. Frequent blood glucose

testing is important. It tells you how your diabetes is

affected by factors such as medication, diet, exercise,

and stress management. Blood glucose test results can

also tell you if your diabetes is changing in ways that

affect your treatment plan. Always consult your diabetes

healthcare professional before making any changes.

All of the information needed to use the GLUCOCARD®

Vital™ System is included in this manual. Please read it

thoroughly before using the system. If you have any

questions, call ARKRAY’s Customer Service at 800.566.8558

(24 hours a day, 7 days a week, USA and Canada only).

Contact your healthcare professional with questions if you

are unable to reach Customer Service.

Intended Use

The GLUCOCARD®Vital™ Blood Glucose Monitoring

System is intended for the quantitative measurement of

glucose in fresh capillary whole blood samples drawn from

the ﬁngertips or palm. Testing is done outside the body

(

In Vitro

Diagnostic Use). It is indicated for use at home

(over the counter [OTC]) by persons with diabetes, or in

clinical settings by healthcare professionals, as an aid

to monitor the effectiveness of diabetes control. It is not

intended for the diagnosis of or screening for Diabetes

Mellitus, and is not intended for use on neonates.

INTRODUCTION

Important Information

• Test results below 70 mg/dL indicate low blood glucose

(hypoglycemia)

• Test results above 240 mg/dL indicate high blood

glucose (hyperglycemia)

• If results are below 70 mg/dL or above 240 mg/dL,

repeat the test

• If results continue to measure below 70 mg/dL or

above 240 mg/dL consult your diabetes healthcare

professional immediately

• If symptoms are not consistent with test results AND all

the instructions have been followed carefully, contact

your diabetes healthcare professional

• Before testing, always make sure both the meter and

test strips are at operating temperature

The GLUCOCARD®Vital™ System Includes:

• GLUCOCARD®Vital™ Meter

• Carrying Case

• User Instruction Manual

• Self-testing Logbook

• May include Test Strips, Control Solution, and Lancing

Device and/or Lancets

Front

Back

The GLUCOCARD®Vital™ Meter

Display Screen

Back Button

On/Off Button

Forward Button

Battery Compartment

Cover

Test Strip Port

Explanation of the Full Display Screen

Time

Date

Average Test

Reading

Control

Solution Test

Low

Battery

Unit of

Measurement

Temperature

Warning

Test Strip

Apply Blood

Insert/Remove

Test Strip

Memory Mode

Error Code

Result Warning

Main Display:

Test Strip Code

Test Countdown

Test Results

Error Codes

If any part of the display screen is missing when the meter

is turned on call Customer Service at 800.566.8558.

GETTING TO KNOW THE GLUCOCARD®VITAL™

BLOOD GLUCOSE METER

1110

Meter Set Up

Before using the GLUCOCARD®Vital™ Meter for the ﬁrst

time, you must set the time and date. You can choose

between the 12-hour format (1-12 o’clock with am or pm)

and the Military 24-hour format (0-23). The date format

can either be displayed as month/day (U.S.A. format) or

day/month (International format). Do not perform a blood

glucose test until you have set the meter correctly.

Setting the Time and Date

Step 1 – Turn on meter

Press the On/Off button to turn the meter on. The full

screen appears brieﬂy. If any part of the display screen

is missing (see page 9), call Customer Service. The meter

then displays the time, date, unit of measurement, and

the insert strip symbol.

Step 2 – Enter set-up mode

Press and hold down the On/Off button for more than

2 seconds to enter the set-up mode.

Step 3 – Set the time format

The time can be displayed in either 24-hour format or

12-hour format with AM and PM. The meter displays the

current time format. To change format, press either the

Back or Forward button. Press the On/Off button to select

the time format. The date format then appears on the

display.

Step 4 – Set the date format

The date format can either be displayed as month/day

(01/31) or day/month (31/01). The meter displays the

current format. To change format, press either the Back or

Forward button. Press the On/Off button to select the date

format. The hour setting then ﬂashes on the display.

Month/Day

Format

Day/Month

Format

1312

Step 5 – Set the hour

Press and release the Back or

Forward buttons to change the hour.

Hold the Back or Forward button down

to scroll through quickly. When the

correct hour is displayed, press the

On/Off button. The minute setting then

ﬂashes on the display.

Step 6 – Set the minute

Press and release the Back or Forward

buttons until the correct minute

appears. Hold the Back or Forward

button down to scroll through quickly.

When the correct minute is

displayed, press the On/Off button.

The month setting then ﬂashes on the

display.

Step 7 – Set the month

(If day/month format is selected then

Step 7 will set day)

Press and release the Back or Forward

buttons until the correct month

appears. Hold the Back or Forward

button down to scroll through quickly.

When the correct month is displayed,

press the On/Off button. The day

setting then ﬂashes on the display.

Step 8 – Set the day

(If day/month format is selected then

Step 8 will set month)

Press and release the Back or

Forward buttons until the correct day

appears. Hold the Back or Forward

button down to scroll through quickly.

When the correct day is displayed,

press the On/Off button. The year

setting then ﬂashes on the display.

Step 9 – Set the year

Press and release the Back or

Forward buttons until the correct

year appears. Hold the Back or

Forward button down to scroll through

quickly. When the correct year is

displayed, press the On/Off button

for two seconds to exit set up mode.

Note:

Pressing the On/Off button for more than 2 seconds at

any stage saves the time and date and exits the set-up

mode. The meter automatically shuts off after 2 minutes

if no buttons are pressed. Settings stored up to that point

are saved.

Hour ﬂashing

Minute ﬂashing

Month ﬂashing

Day ﬂashing

Year ﬂashing

1514

Display Screen Messages

A list of all display screen messages is included below.

If you have any questions after reading these messages,

or if the meter displays a message not listed here, call

Customer Service at 800.566.8558 (24 hours a day, 7 days

a week, USA and Canada only). If the display screen

shows , you should be able to clear the error message

yourself. Do not send your meter to ARKRAY or your local

dealer without authorization from a company

representative.

Your blood glucose level is less

than 20 mg/dL. Repeat the test

using a new test strip. If this

message appears again, contact

your healthcare professional

immediately.

Your blood glucose level is more

than 600 mg/dL. Repeat the test

using a new test strip. If this

message appears again, contact

your healthcare professional

immediately.

The battery has been replaced.

Check that the time and date are

set correctly.

A used strip has been inserted

or the meter is having difﬁculty

reading the strip.

Repeat the test with a new

test strip.

The battery power is getting low.

There is enough power for

approximately 100 tests before the

battery needs to be replaced.

1716

The battery power is low.

There is only enough power for

about 20 more tests. Replace with

a new CR2032 battery as soon as

possible.

The battery power is too

low for testing.

Replace with a new

CR2032 battery.

Thermometer ﬂashing.

The meter and test strips are

outside the optimum temperature

range of 50°F - 104°F (10°C - 40°C).

Make sure your meter and

strips are in an environment

with a temperature between

50°F - 104°F (10°C - 40°C).

Treat test result obtained where

the thermometer is ﬂashing with

caution. The ﬂashing thermometer

will be displayed on all screens

during glucose testing until the

meter has reached acceptable

temperature. Readings obtained

with the ﬂashing thermometer will

show a thermometer when results

are recalled in memory.

Thermometer symbol - E6.

Temperature outside of

acceptable range of 41°F - 113°F

(5°C - 45°C). You will not obtain a

reading. Allow the meter and strips

to warm up or cool down slowly to

between 50°F - 104°F (10°C - 40°C)

or at least to 41°F - 113°F

(5°C - 45°C).

1918

Corrupted memory.

Call Customer Service at

800.566.8558.

Meter Memory

Marking Results in the Memory

You can mark results in the meter memory in two ways.

Marking Control Solution Tests

You must mark results with the control bottle symbol .

Insert test strip into the meter. Hold the Back or Forward

button until appears in the upper right corner of the

screen. Do this BEFORE performing a control solution

test. If you do not mark control solution tests before

applying control solution to the test strip, the results

may not be accurate and control solution test results

will be included in your test result averages.

The meter does not use results marked when it

calculates the 14- and 30-day average. This ensures that

your 14- and 30-day average includes only results from

testing your own blood.

Not enough blood was

added to test strip.

Retest with new test strip. Apply

at least 0.5µL of blood to sample

application tip.

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