VocalPoint SMS-4250 Owner's manual

SMS-4250

Blood Glucose Monitoring System

Version 1.0 June, 2009

311-4250200-002

Owner’s Manual

2

Dear VocalPoint SMS-4250 System Owner:

This manual contains important information you must

know about the system. Please read it thoroughly and

carefully and use only with Test Strip.

The most unique feature of this system is its speaking

function which is an acoustic aid for users.

Another unique feature is its no code function which

means no need to calibrate your meter, and makes you

easily monitor blood glucose at home.

3

IMPORTANT SAFETY INSTRUCTIONS

READ THIS BEFORE USING

The following basic safety precautions should always

be taken.

KEEP THESE INSTRUCTIONS

Close supervision is necessary when the device is 1.

used by, on, or near children, handicapped persons or

invalids.

Use the device only for the intended use described in 2.

this manual.

Do not use accessories which are not supplied by the 3.

manufacturer.

Do not let the equipment or its exible cord come into 4.

contact with surfaces which are too hot to touch.

Do not use the equipment where aerosol sprays are 5.

being used, or where oxygen is being administered.

Do not use device if it is not working properly, or if it 6.

has suffered any damage.

Read all instructions thoroughly and practice the test 7.

before using the product to test your blood glucose.

Do all quality control checks as directed and consult

with a diabetes healthcare professional.

4

TABLE OF CONTENTS

IMPORTANT SAFETY INSTRUCTIONS 03

IMPORTANT INFORMATION 06

ABOUT ALTERNATIVE SITE TESTING (AST) 07

INTRODUCTION TO THE SYSTEM 10

Intended Use 10

Principle of Measurement 10

Contents of the System 10

Meter Appearance and Key Functions 12

Meter Display 13

Test Strip 14

BEFORE USE 15

Battery Replacement 15

Setting the Meter and Deleting the Memory 18

BEFORE TESTING BLOOD GLUCOSE 25

Performance Checks with VocalPoint Control Solutions 25

Important Control Test Information 26

Performing a Control Test 27

TESTING YOUR BLOOD 31

Test Procedure 32

Expected Test Results 40

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COMPARING METER AND LABORATORY RESULT

41

USING THE METER MEMORY 43

Viewing Results on the Meter 43

Viewing Results on a Personal Computer 48

TAKING CARE OF YOUR METER AND TEST STRIPS 50

Cleaning 50

Storage 50

PROBLEM-SOLVING GUIDE 53

Special Message 54

Error Message 55

Operational Problem 56

SPECIFICATIONS 58

SUMMARY OF OPERATION 59

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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 higher or lower than usual, follow the

treatment advice of your healthcare professional.

Use only capillary whole blood sample to test your ▪

blood glucose. Using other substances will cause

wrong results.

If you are experiencing symptoms that are inconsistent ▪

with your blood glucose test results and you have

followed all instructions described in this owner’s

manual, call your healthcare professional.

Inaccurate results may occur in severely hypotensive ▪

individuals or patients in shock. Readings which are

lower than actual values may occur for individuals

experiencing a hyperglycemic-hyperosmolar state,

with or without ketosis. Critically ill patients should not

be tested with blood glucose meters.

Please refer to your test strip package insert for ▪

additional important information.

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Important: There are limitations for doing AST.

Please consult your healthcare professional before

you do AST.

What is AST?

Alternative site testing (AST)

means that people use

parts of the body other than

the fingertips to check their

blood glucose levels. This

system provides you to test

on the palm, the forearm,

the upper arm, the calf, or

the thigh with the equivalent

results to ngertip testing.

What’s the advantage?

Fingertips feel pain more

readily because they are full

of nerve endings (receptors).

At other body sites, since

nerve endings are not so

condensed, you will not

feel as much pain as at the

ngertip.

ABOUT ALTERNATIVE SITE TESTING (AST)

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When to use AST?

Food, medication, illness, stress and exercise can

affect blood glucose levels. Capillary blood at fingertip

reects these changes faster than capillary blood at other

sites. Therefore when testing blood glucose during or

immediately after meal, physical exercise, or any other

event, take blood sample from your nger only.

We strongly recommend you do AST ONLY in the

following intervals:

In a pre-meal or fasting state (more than 2 hours since ▪

the last meal).

Two hours or more after taking insulin. ▪

Two hours or more after exercise. ▪

Do NOT use AST if:

You think your blood glucose is low. ▪

You are unaware of hypoglycemia ▪

You are testing for hyperglycemia ▪

Your AST results do not match the way you feel. ▪

You are testing for hyperglycemia. ▪

Your routine glucose results are often uctuating. ▪

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Please follow suggestions below before getting a drop

Rub the puncture site about 20 seconds before ▪

penetration.

Use a clear cap while setting the lancing device. ▪

How to increase the accuracy?

Stimulating blood perfusion by rubbing the puncture site

prior to 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 signicantly reduced.

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INTRODUCTION TO THE SYSTEM

▼ Intended Use

▼ Contents of the System

▼ Principle of Measurement

This system is intended for use outside the body (in vitro

diagnostic use). It should be used only for testing glucose

(sugar) and only with fresh capillary whole blood samples

(from the finger, the palm, the forearm, the upper arm,

the calf and the thigh). The system is intended for use at

home and in clinical settings. It should not be used for the

diagnosis of diabetes or for the testing of newborns.

AST in this system can be used only during steady-state

blood glucose conditions described in the section of “About

Alternative Site Testing (AST)”.

The system consists of three main products: the blood

glucose meter, test strips, and a control solution. These

products have been designed, tested, and proven to work

together as a system to produce accurate blood glucose

test results. Use only the same brand-name test strips and

a control solution with the blood glucose meter.

The test 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 and displays

the corresponding blood glucose level. The strength of the

current produced by the reaction depends on the amount

of glucose in the blood sample.

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1) A Meter 2) Owner’s manual

3) Carrying bag 4) First time user guide

5) Daily log book 6) Warranty card

7) 2 AAA alkaline batteries

If your system has been opened prior to use or it does 1.

not contain all parts listed above, please return your

system to the place of purchase.

Test strips, control solutions and lancets are optional. 2.

They are not included in the standard kit. Please

contact your local agent or place of purchase for

availability.

PLEASE NOTE

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▼ Meter Appearance and Key Functions

2

1

9

4

5

8

11

10

7

6

3

1. LCD SCREEN - guides you through the test using symbols and simple

messages.

2. STRIP-EJECTION BUTTON- is where the used strip will be

automatically ejected after you push up the button.

3. TEST SLOT- is where you insert the test strip. The meter will turn on

automatically after insertion.

4. UP BUTTON & 5. DOWN BUTTON- is used to adjust setting and the

speaking volume.

6. M BUTTON- located in front of the meter with “M” on it, is used to turn

on the meter and enter the memory.

7. SET BUTTON- is used to set up the meter

8. EARPHONE JACK

9. DATA PORT- located at the side, is for cable connection.

10. REPEAT BUTTON- is used to replay the previous recording which

you want to hear again while operating the meter.

11. BATTERY COMPARTMENT (Behind of meter)

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▼ Meter Display

TEST RESULT AREA

BLOOD DROP SYMBOL

Displays glucose results.

A decimal point appears

when the measurement

unit is mmol/L.

VOICE SYMBOL

Indicates speaking

function is on/off.

TEST STRIP SYMBOL

Flashes when meter is ready for

sample application.

KETONE WARNING

LOW BATTERY SYMBOL

Appears when the battery

power is low.

MEMORY SYMBOL

Appears when you review the memory.

Flashes when meter is ready

for sample application

CTL SYMBOL

DAY AVERAGE

DATE

TIME

control test and indicates

that the result won't be

stored in the memory.

Indicates that the displayed

test result is an average.

Appears when the

test result is equal to or

higher than 240mg/dL

(13.3 mmol/dL).

Appears when doing a

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▼ Test Strip

Your system measures the amount of sugar (glucose) in

whole blood. Blood is applied to the absorbent hole of the

test strip and is automatically drawn into the reaction cell

where the reaction takes place.

The test strip consists of the following parts:

Contact Bars

Insert this end of the test strip into the meter.

Push it in rmly until it will go no further.

Test Strip Handle

Hold this part to insert the test strip into the

slot.

Conrmation Window

This is where you confirm if enough blood

has been applied to the absorbent hole of

the strip.

Absorbent Hole

Apply a drop of blood here and

the blood will be sucked up automatically.

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BEFORE USE

▼ Battery Replacement

Your meter comes with two1.5V AAA size alkaline

batteries that are already installed.

The meter will alert you when the power is getting low by

displaying two different messages:

The 1. symbol appears together with other display

messages: the meter is functional and the result

remains accurate, but it is time to change the

batteries.

2. The symbol appears with the “E-b” symbol, “Error”

and “low”: the batteries can not provide enough

power to do a test. You must change the batteries

immediately.

Battery is low, please replace.

Battery is dead, please

change.

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Replacing the batteries does not affect the test results •

stored in memory.

Batteries might leak chemicals if unused for a long •

time. Remove the batteries if you are not going to use

the device for an extended period (i.e., 3 months or

more).

PLEASE NOTE

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To replace the batteries, make sure that the meter is

turned off.

STEP 1 Press the edge of the battery cover and lift it up to

remove.

STEP 2 Remove the old batteries and replace with two

1.5V AAA size alkaline batteries.

STEP 3 Close the battery cover. If the batteries are

inserted correctly, you will hear a "beep".

As with all small batteries, these batteries should be kept

away from small children. If they are swallowed, promptly

see a doctor for help.

WARNING

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▼ Setting the Meter and Deleting the Memory

Your meter comes with the language, voice volume,

year, month, day, hour, minute, unit of measurement

and memory deletion. If you need to change the time or

replace the batteries, however, you may need to enter the

setting mode and reset.

Please set voice volume, year, month, day, hour, minute,

and memory deletion according to the following steps.

Start with the meter off. Then keep pressing the S

button for 3 seconds.

The meter is now in the setting mode.

You can start setting up the meter.

You are now in setting mode.

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STEP 1 Select Speaking Volume Function

Press the Up and Down buttons until you hear the desired

speaking volume. Number 0 indicates that the speaking

function is turned off, “ ” will not display on LCD during

testing. Numbers 1 to 7 indicates speaking volume from

low to high. At this time “ ” will be displayed on LCD

during testing. Press the S button and then the year

segment ashes.

STEP 2 Set the Year

Press the “Up” or “Down” button until the desired year

appears. Press the S button and then the month segment

ashes.

Voice volume is 7.

The Year is 2009.

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STEP 3 Set the Month

Press the “Up” or “Down” button until the desired month

appears. Press the S button and then the date segment

ashes.

STEP 4 Set the Date

Press the “Up” or “Down” button until the desired date

appears. Press the S button and then the hour segment

ashes.

The month is January.

The date is 18th.

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VocalPoint SMS-4250 Owner's manual

VocalPoint SMS-4250 Owner's manual

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