VocalPoint SMS-4250 Owner's manual

Category
Measuring, testing & control
Type
Owner's manual
SMS-4250
Blood Glucose Monitoring System
Version 1.0 June, 2009
311-4250200-002
Owners 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
5
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
6
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.
7
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)
8
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.
9
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.
10
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.
11
1) A Meter 2) Owners 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
12
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)
13
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
14
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.
15
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.
16
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
17
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
18
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.
19
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.
20
STEP 3 Set the Month
Press the “Upor 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

Category
Measuring, testing & control
Type
Owner's manual

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