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SuperCheck2 6277 User manual

USER GUIDE
6277AP-M01A2
Blood Glucose Monitoring System
Model:6277
No Coding
Required
SuperCheck2
SuperCheck2
Rev.date:06/2011
Explanation of symbols:
Important Notice to Reader of this Manual
This manual is written for the Btm SuperCheck2 meter:
model 6277 Voice Meter . The Btm SuperCheck2
Model 6277 contains a speaking function that provides
audible messages to help the user for using the meter
and hearing the test results. In the manual you will
read many audible sentences, which is only for the
model 6277. If you don't want to hear any sentences
from meter, please refer the section 8: Settings, and
you can adjust the meter to “Voice Off”.
Caution (refer to accompanying documents).
Please refer to safety-related notes in the
manual accompanying this instrument.
Consult instructions for use.
Keep away from sunlight.
O
86 F
O
30 C
O
46 F
O
8 C
Authorised representive in the
european community.
Manufacturer
Do not reuse
Use by / Expiry date
Lot number
In vitro diagnostic medical device.
Temperature limitation
1. Contents
Section Topic Page
1. Table of Contents
2. Introduction
3. Appearance and Key Functions of the meter
4. Alternate Site Testing
5. Safety Information
6. Quick Testing Instructions
Date/Time/Alarm/
Memory Deletion /Voice volume)
9
Preparing for Testing
7. Installing the Battery
8. Settings (
.Running a Control Solution Test
Blood Testing
10.Running a Blood Glucose Test
11.Recalling the Memory and Viewing the Average
12.Expected Values
13.Transmitting Results
Maintenance
14.Maintenance of Your System
15.Troubleshooting
16.Customer Service
17.Limitations
Important Additional Information
18. Specifications
19. Ordering Supplies
20. Warranty Information
1
1
2-3
4
5-8
9
10
11
12-16
17-18
19-21
22-23
24
24
25
26-27
28
29
30
30
31
NOTE: For information about the name of the manufacturer of
the lancing device and the lancets, please refer to the package
inserts that came with your starter kits.
2
2. Introduction to the System
Intended Use / Indications for Use
The Btm SuperCheck2 Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary
whole blood from the finger and the forearm. It is intended for use as
an aid by either a healthcare professional or a patient diagnosed with
diabetes mellitus for monitoring their blood glucose levels when self
testing. The Btm SuperCheck2 Blood Glucose Monitoring
System is not intended for the diagnosis of or screening for
diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used
during steady-state blood glucose conditions.
Contents of the System
This User Guide has been prepared to describe the proper use
of the Btm SuperCheck2 Blood Glucose Monitoring System.
Please read this User Guide carefully including the package
inserts before testing. The system is available as either a meter
or as a complete starter kit. If you have a meter only you can
purchase any additional spares from your system provider.
The Btm SuperCheck 2 Blood Glucose Monitoring System contains
the following items:
1.SuperCheck2 Glucose Meter with 2 AAA batteries
2.User Guide
3.Log Book
4.Carrying Case
5.SuperCheck2 Glucose Test Strips
6.SuperCheck2 Control Solution (Medium)
7.Sterile Lancets
8.Lancing Device
9.Package Inserts for Test Strips, Control Solution,
and Lancets/Lancing Device
"A single level control solution (Medium) is provided in the
"Starter Kit,". You may purchase any control solutions that you
need from your system provider."
The Btm SuperCheck2 Glucose Meter uses Btm SuperCheck2
Glucose Test Strips. Neither the meter nor the test strips will work when
used with any other brand of glucose products.
3
4
3. Appearance and Key functions
of the meter
The principle of the method
When glucose reacts with the reagents on the test strips, an electrical current
is produced, which is proportional to the glucose concentration in the blood sample.
The glucose concentration is calculated by the meter and based on the current measured.
1.Test strip slot - When the strip is inserted into the
slot, the meter will automatically turn on.
2. LCD Display - Guide you through the test using
symbols and simple messages.
3. M Key - Power ON/OFF, also for memory recalling
mode, please refer to manual for detailed function
description.
4. C Key - Setting mode, please refer to manual for
detailed function description.
5. Speaker - Where voice comes out.
6. RS232 port - Cable connection and data transmitting.
7. Battery Compartment - Where batteries are
located.
8. Ejector - Remove used strip.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
*If your meter has the back light feature, this will come on automatically
during every operation to help user readability and to assist with the
smooth operation of your meter .
5
4. Alternate Site Testing (AST)
What is AST?
AST is the sampling from anatomical sites (parts of the body)
other than the fingertip (i.e. forearm) to check the blood
glucose levels. This system allows you to test on the forearm
with the equivalent results to fingertip testing.
There are important limitations to AST. Please consult your
healthcare professional before you use AST.
What is the advantage ?
Some patients may encounter discomfort when taking a blood
sample from the fingertip as the finger tips have a high
concentration of nerve endings. Other body sites do not have
as many nerve endings, so you will not feel as much pain as at
the fingertip.
When to use AST ?
Medication, stress, illness, food and exercise can affect blood
glucose levels. Capillary whole blood at the fingertip can reflect
test changes faster than capillary blood at other sites of body. If
you test your blood glucose level during or immediately after
a meal, physical exercise or stressful events, take the other
sites of the body blood sample from your fingertip instead of
from other sites.
Use AST only:
1. 2 hours or more after taking insulin;
2. 2 hours or more after a meal;
3. 2 hours or more after exercise.
Do not use AST if you are pregnant, or if you are aware that
your glucose level is not as stable as usual, or if you think
you have hypoglycemia (low blood sugar) or hyperglycemia
(high blood sugar).
Do not use AST if you think your blood glucose is low and if
your AST results do not match the way you feel.
6
1.Please unscrew the lancing device
by turning the end cap counter
clockwise. A clear cap will come
with the package of a meter kit or
a lancing device. The clear cap on
the lancing device will make it easy
for you to get a drop of blood for
AST.
2.Insert a new lancet firmly into the
lancet holder.
3.Twist off the protective top of the
lancet.
4.Close the end cap of the lancing
device and grasp the lancing device
as shown. Slide into locking position.
If necessary, please set the lancing
device for a deeper puncture.
5.Select a soft, fleshy area on your
forearm that is clean and dry, away
from bone and free of visible veins
and hair.
1
2
3
4
5
Testing Procedure for AST
7
6.Massage the selected area gently
to increase blood flow to the
puncture site. Clean the test location
with an alcohol wipe or with soap
and water
.
7.Open the test strip vial. Take one
test strip out of the vial and quickly
cover the vial to keep air out.
8.Insert a test strip into the meter
while the meter is off. The meter
will turn on automatically, and you
will hear: “Hello, the Meter is
ready.” A blinking blood icon will be
displayed on the screen. You will
hear “Apply blood now.” If no
action is taken in 2 minutes, the
meter will turn off automatically.
You will hear: “Goodbye.”
9.Press and hold the loaded lancing
device against the forearm for a few
seconds, then press and release the
button.
6
7
8
9
8
10
11
12
10. Wait for a few seconds until the
blood drop forms. Make sure you
have sufficient blood to fill the
small window of the test strip. For
individuals who experience
difficulty in getting sufficient blood
for a test, it may be helpful to rub the
puncture site a little longer before
using the lancing device.
11. Apply your blood to the front
edge (the tip) of the test strip, and
the meter will start counting down
for 6 seconds then display the test
results on the screen. You will hear:
“Testing in process.” and “The
glucose level is number/unit.”
12. Remove the used strip by hand
or by pushing the ejector button. The
meter will turn off automatically,
and you will hear: “Goodbye”, and
the LCD screen will display “OFF”.
9
5. Safety Information
Please use this device only for the intended use described
in this user guide.
Before using this system to test your blood glucose
please read the instructions carefully and practice the test
when you first use this system. Do a quality check on
the system following the instructions and consult
with your healthcare professionals for questions or
problems.
Be aware of the safety of young children or handicapped
persons near you when you conduct a glucose test using
this system.
Please keep the test strip vial away from children. The
test strips and vial cap can present a choking hazard.
Please be cautious when removing the lancet. Take the
lancet out carefully. Always place the protective cap
back on the exposed tip or (if using a twist lancet)
place the cap on a hard surface and push the exposed tip
into the protective cap and discard of properly.
Never try to disassemble the meter in any circumstance.
If your meter is not working properly, or if you need the
Technical Support, please contact your local distributor
for help.
10
6. Quick Testing Instructions
1.With the meter turned off, insert
a new test strip into the meter, and
you will hear: “Hello, the Meter is
ready.” A blinking blood icon will
be displayed on the screen. You will
hear “Apply blood now.”
2.Lance the finger and let a blood
drop form.
3.Apply the blood drop to the front
edge of the test strip when the blood
drop icon is still blinking on the
meter. Wait for 6 seconds, and the
meter will display the test result.
You will hear: “Testing in process.”
and “The glucose level is
number/unit.”
4.Remove the used strips by hand or
by pushing the ejector and the meter
will power off with a display of
“OFF” on the screen. You will hear:
“Goodbye.”
(For detailed instructions start on page 18 for Control
Solutions and page for Blood Testing.)
20
1
2
3
4
7. Installing the battery
1.Turn off the meter by pressing the
“M” button and hold for 2 seconds
before replacing the batteries.
Slide down the battery cover on
the back of the meter by pushing
the cover in the direction of the
arrow and put the cover aside.
2.Remove the two used batteries.
3.Insert 2 new batteries with
correct +/- direction.
(Battery:AAA 1.5V 2 Alkaline 24A LR03)
4.Put the battery cover back in
place by pushing the cover in the
opposite direction of the arrow to
close the cover into position.
11
Note:
1.It is suggested that batteries need to be
replaced when the battery icon appears
empty. If you keep using the meter, the
battery icon will start flashing and an error
message E_3 will appear on the screen.
2.Note that replacing the battery will not
reset the stored testing results.
3.You need to reset the time and date after
the batteries are replaced.
4.If there is any unexpected symbol on the
display, please follow the above procedure
to replace the batteries again.
5.Please dispose of batteries according
to your local ordinances.
1
2
3
4
8.Settings ( Date / Time / Alarm /
Memory Deletion / Voice Volume)
1.Appears with the test result or in mmol/L.
2.Appears when you recall the memory.
3.Appears when you are in setting mode.
4.Appears for control solution test flag (c).
5.Indicates the meter is ready to take the blood sample when it flashes.
6.Indicates the battery status.
7.Indicates if audio function is on or off.
8.Indicates current displayed result is an average.
9.Appears when alarm is on.
10.Month
11.Day
12.Hour
13.Minute
(1)Measurement Units
(6)Battery Symbol
(3)Setting
(2)Memory
(10)Month
(11)Day (12)Hour
(13)Minute
The LCD screen will show as below:
(4)Test flag
(5)Blood drop icon
(7)Voice Symbol
(Speaker icon)
(8)Day Average
(9)Alarm
Reminder
12
The LCD screen for Power Off - When the meter is off, the date, time,
measurement unit, battery icon and “OFF” will be still on the screen. If the
voice is on or the alarm reminder is on, the speaker icon and the alarm icon
will be displayed as well.
1.
2.
3.
Set the Year - Press C key to adjust the year
until the desired year is displayed and then
press the M key to confirm the year setting.
When pressing the C key, the year will be
adjusted in the range of 2009 to 2029. After
the year setting is confirmed, you will see the
month segment flashing on the screen.
(Each time you press the C key to adjust the
year, you will hear: “The year is 20xx.” If
year 09 is selected, and you will hear: “The
year is 2009.”)
Set the Month - Press C key to adjust the month
until the desired month is displayed and then
press the M key to confirm the month setting.
You will then see the day segment is flashing
on the screen. (Each time you press the C key
to adjust the Month, you will hear: “The
month is xxx.” If December is selected, and
you will hear: “The month is December.”)
Set the Day - Press C key to adjust the day
until the desired day appears and then press
the M key to confirm the day setting. You will
then see the hour segment is flashing on the
LCD screen. (Each time you press the C key to
adjust the day, you will hear: “The day is xxx.”
th
If 18 is selected, and you will hear: “The day
is the eighteenth.”)
1
2
3
13
:
1-01~01 01
AM
SETSET
:
12-01~0101
AM
SETSET
:
12-18~0101
AM
SETSET
Set the Hour - Press C key to adjust the hour
until the desired hour appears on the screen
and then press the M key to confirm the
setting. You will then see the minute segment is
flashing on the screen. (Each time you press
the C key to adjust the Hour, you will hear:
“The hour is xxx.” If 11 pm is selected, and
you will hear: “The hour is eleven PM.”)
Set the Minute - Press C key to adjust the
minute until the desired minute appears on the
screen and then press the M key to confirm the
setting. You will then see an “AL” displayed on
the screen center. (Each time you press the C key
to adjust the Minute, and you will hear: “The
minute is xxx.” If 25 minute is selected, and
you will hear: “The minute is twenty five.”)
5.
6.Set the Alarm Reminder - Press C key to toggle
between the alarm reminder setting or
no-setting mode. (If setting alarm is selected,
and you will hear: “Ready to set Alarm
Reminder.”) If you see the LCD display a
small flashing icon of alarm clock in the
lower left corner with a time segment display,
it means that you are in the alarm setting mode.
If you see only AL without the icon of the small
alarm clock, it means that you are not in the
alarm setting mode. Press M key to confirm the
alarm setting mode. If you select the alarm setting mode, alarm
clock icon will stop flashing and the hour of the time segment will
start flashing. You will hear: “Ready to set Alarm Reminder.”
Press C key until the desired alarm hour appears and then press M key
to confirm the hour setting. ( If 8 AM is selected, and you will hear:
“The hour is eight AM.”) Then the minute segment will start flashing.
Press C key until the desired minute appears on the screen and then
press M key to confirm the minute setting. (If 25 minute is selected,
and you will hear: “The minute is twenty five.”) You will see the
measuring unit flashing on the upper left corner of the LCD display.
(Each time you press C key to adjust the hour, and you will hear:
“The hour is xxx.” Each time you press the C key to adjust the minute,
and you will hear: “The minute is xxx.” At the end of this process,
and you will hear: “Alarm Reminder Set.”)
14
5
:
12-18~1101
PM
SETSET
6
:
12-18~1125
PM
SETSET
:25
08
AM
SETSET
4
4.
Delete Memory - Press C key to toggle
between a flashing “dEL” for memory
deletion or a non-flashing “dEL”. If you
want to delete all memory, press M key while
the “dEL” is flashing. If you do not want to
delete all memory, press M key when the
“dEL” is not flashing. Once the M key is
pressed, the LCD display will move to the
setting of voice volume setting mode. You
will see the display of “VoL” in the center of
screen. (When the “dEL” is flashing on the
screen, and you will hear: “Ready to delete
memory records.”)
7.
8. Set the Voice Volume - Press C key to toggle
between the selection of speaking mode and
non-speaking mode. If you want to turn off
the speaker, press M key when the screen
does not show the small speaker icon. You
will hear: “Voice Off.” If you see a small
speaker icon appears below the battery icon
on the right side of LCD screen, you can
press M key to turn on the speaker. Then you
will see the existing voice volume level at
the lower right corner of the screen. There
are 7 levels of voice volume. You can press C key to adjust the voice
level and then press the M key to confirm the setting. (There will be
a “beep” sound to indicate the level of voice volume adjusted.)
The meter will turn off automatically after 2 seconds with a display
of “OFF”, and you will hear: “Goodbye.”
8
15
7
Note:
1.When you change the date and time backward, you will not
change the test results in the meter memory.
2.You need to move through the language, year, month, day, hour,
minutes, alarm, measurement unit, dEL, and VoL to save the
meter settings and turn off the meter.
3.The average readings in the meter memory are calculated from
the results obtained during the 7, 14, 28, 60,and 90 calendar
days preceding the current date and time settings.
Power off Screen- When the meter is off, the
time, date, measurement unit, and battery icon
will be still on the screen as Figure 11. If the
alarm reminder has been set or the voice has
been turned on, then the alarm or the speaker
icon will appear on the power off screen as
well. The LCD screen will display “OFF”.
9.
16
9
9.Running a Control Solution Test
IMPORTANT:
Always make sure you press C key for Control Solution test,
otherwise the control solution test result will be stored in the
memory, and affect your“AVG”results.
2.Press the C key, and the meter will
display a letter “C” on the upper right
corner of screen, indicating the control
test mode. You will hear: “Apply Control
Solution now.” The test result will not be
stored in the memory.
3.Squeeze a small amount of Control
Solution on a flat surface and apply to
the front edge of the test strip, and you
will hear: “Testing in process.”
4.Wait for 6 seconds, and the meter will
display the result. You will hear: “The
glucose level is number/unit.”
5.Remove the used strips by hand or by
pushing the ejector and the meter will
power off with a display of “OFF” on the
screen. You will hear: “Goodbye.”
1.Insert a strip into the meter, and you
will hear: “Hello, the Meter is ready.”
A blinking blood icon will be displayed
on the screen. You will hear: “Apply
blood now.”
1
2
3
4
5
17
IMPORTANT!!!
1.You must press the C key to distinguish the control solution
test from the blood glucose test. Do not perform the blood
test in Control Solution mode.(If you perform the blood
test in Control Solution mode, the test result will not be
stored in the memory.)
2. Use only Btm SuperCheck2 Control Solution with Btm
SuperCheck2 Glucose Meter.
3.Btm SuperCheck2 Control Solutions are used to check that
the meter and the test strips are working together as a
system and that you are performing the test correctly.
4.Btm SuperCheck2 Control Solution contains a known amount
of glucose that reacts with test strips. The Medium and
High level Control Solution are intended to check the
monitoring system in different measurement ranges.
5.Shake the vial, discard the first drop of control solution, and
wipe off the dispenser tip to ensure a good sample and an
accurate result.
6.Use only for 3 months after first opening. Record the open
date on the Control Solution vial. Discard after 3 months.
7. Compare your Control Solution test results with the expected
range printed on the test strip vial label. If your glucose
control results fall outside the expected range; repeat the
test. Results that repeatedly fall outside the expected
range may indicate:
(1)You may not be doing the test correctly; repeat the test, by shaking
the control solution vial well and carefully following instructions.
Please make sure the test is done within the temperature range.
(2)The Control Solution is expired or contaminated.
(3)The test strips are damaged or outdated.
(4)You may have applied the Control Solution before the blood drop
appears on the screen. This will cause incorrect glucose measurement.
(5)Meter malfunction.
18

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