QRG prof.book Page 1 Tuesday, September 17, 2002 1:41 PM
©2002, 2000 LifeScan, Inc. All rights reserved.
The system described herein is covered by one or more of the
following US patents: D444,235, D367,109, 5,418,142, 5,515,170,
5,526,120, 5,563,031, 5,605,837, 5,780,304, 5,789,255,
5,922,530, 5,968,836, and 6,335,203. Use of the system described
herein is protected under US patent 4,935,346. Purchase of the
system described herein does not act to grant a license under these
patents. Such a license is granted only when the device is used with
SureStepPro or OneTouch SureStep Test Strips. No test strip supplier
other than LifeScan is authorized to grant such a license, and LifeScan
does not endorse or encourage the use of any strips manufactured by
anyone other than LifeScan.
QRG prof.book Page 1 Tuesday, September 17, 2002 1:41 PM
Contents
The SureStepFlexx Meter . . . . . . . . . . . 1
Scanning a Barcode . . . . . . . . . . . . . . 2
Performing a Quality Control Test . . . . 3
Performing a Patient Test . . . . . . . . . . . 7
Blood Application . . . . . . . . . . . . . . 11
Color Chart . . . . . . . . . . . . . . . . . . . . 13
Transferring Data . . . . . . . . . . . . . . . . 14
Connection Module . . . . . . . . . . . . . 14
Serial Cable . . . . . . . . . . . . . . . . . . . 15
Cleaning . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning the Outside of the Meter . 16
Cleaning the Test Strip Holder . . . . 16
Changing the Batteries . . . . . . . . . . . . 20
Troubleshooting . . . . . . . . . . . . . . . . . 22
QRG prof.book Page 1 Tuesday, September 17, 2002 1:41 PM
The SureStepFlexx Meter
Refer to this quick reference guide only
after you have become familiar with the
instructions and precautions outlined in
the SureStepFlexx Meter Operator’s Guide.
Power button
Serial port (top)
Test strip holder
LCD screen
Optional barcode scanner/
infrared communication port lens
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Scanning a Barcode
If the meter is equipped with a barcode
scanner, you may scan IDs and lot numbers.
To scan a barcode, hold the
barcode label parallel to and
approximately 2 to 6 inches
from the meter’s scanner.
Press and release the SCAN
button on the screen. After
a successful scan, the information appears in the display
field. Press
to confirm the entry.
Enter Operator ID
9
_./-
1
GHI
ABC
2
JKL
DEF
3
MNO
4
5
6
PQRS
TUV
WXYZ
7
SCAN
8
\:,
0
9
DEL
W
X
Y
Z
■ NOTE: If the SCAN button does not appear,
a barcode scanner is not installed or
enabled, or battery power is too low to scan.
If power is low, change the meter batteries.
▲ CAUTION: Do not stare into the laser
light or point it towards anyone’s eyes
while scanning a barcode.
2
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Performing a Quality Control Test
1 Turn on the meter by pressing the
blue power button.
2 Press Cont on the status screen.
3 Select QC Test from the Main Menu.
4 Select a control test.
5 Enter your operator ID, or scan your
badge. Press
.
6 Select the control solution lot
number, or scan the vial.
7 Select the test strip lot number (and
code), or scan the bottle.
▲ CAUTION: To obtain accurate results, you
must enter the correct test strip lot number
(and code) for each new test.
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8 Gently shake the control solution
vial and touch a drop of solution to
the center of the pink test square.
9 Check the confirmation dot on the
back of the test strip to verify it is
completely blue.
10 Firmly insert the test strip all the way
into the test strip holder until it stops
(confirmation dot should be facing
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down). Insert within 2 minutes of
applying control solution.
◆ IMPORTANT:
If you fail to completely
insert the test strip, the test may start;
however, you may receive an out-of-range
result.
◆ IMPORTANT:
If you insert the test strip
after 2 minutes, you may get an
out-of-range result or an error message.
The QC test result appears in
approximately 30 seconds.
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◆ IMPORTANT: Do not remove the test strip
until the countdown is complete.
Press
and continue
with next control test.
Press Entr Note and choose
at least one comment. Press
and repeat test.
11 Remove the test strip.
▲ CAUTION: If the control solution result
fails, repeat the test. The system may not
be functioning properly. Do not use the
system to test patient blood unless the
control result falls within the expected
range.
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Performing a Patient Test
1 Turn on the meter by pressing the
blue power button.
2 Press Cont on the status screen.
3 Select Patient Test from the Main Menu.
4 Enter your operator ID, or scan your
badge. Press
.
5 Enter the patient ID, or scan the ID
tag. Press
.
6 Select the test strip lot number (and
code), or scan the bottle.
▲ CAUTION: To obtain accurate results, you
must enter the correct test strip lot number
(and code) for each new test.
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7 Apply the patient’s blood to the
center of the pink test square.
8 Check the confirmation dot on the
back of the test strip to verify it is
completely blue.
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9 Firmly insert the test strip all the way
into the test strip holder until it stops
(confirmation dot should be facing
down). Insert within 2 minutes of
applying blood.
▲ CAUTION: If you fail to completely insert
the test strip, the test may start; however,
you may receive an inaccurate, low result.
▲ CAUTION: If you insert the test strip after
2 minutes, you may get an inaccurate result
or an error message.
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The test result appears in approximately
30 seconds.
◆ IMPORTANT: Do not remove the test strip
until the countdown is complete.
Example
10 Remove the test strip.
11 Press
and continue testing.
Or, press Entr Note and choose one
to three comments that correspond
to the patient’s current situation.
Press
.
10
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Blood Application
How to check that you have applied the
right amount of blood:
Enough Blood
Test Strip
pink test
square
Front
white
pad
confirmation
dot
Back
Pink test square is where
you apply blood.
White pad absorbs excess
blood that extends beyond
the pink test square.
Confirmation dot is where
you check for adequate blood
application.
11
Front
Back
Apply a drop of blood to the
center of the pink test square
on the front of the test strip.
Check the confirmation dot
on the back of the test strip.
If the dot is completely blue,
this indicates you have
applied an adequate amount
of blood.
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▲ CAUTION: Do not apply additional blood
to the test strip or you may get an inaccurate
result.
Too Much Blood
Front
If the white pad on the
front of the test strip is
completely saturated with
blood, you have applied
too much blood for an
accurate result. Repeat
the application using a
new test strip.
Not Enough Blood
Back
If the blue confirmation dot
on the back of the test strip
shows streaks or patches of
white, you have not applied
enough blood for an accurate
result. Repeat the application
using a new test strip.
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Test for the measurement
of glucose in whole blood.
For use with SureStep ®
Brand Meters.
For in vitro diagnostic use.
Color Chart
Unused
50 mg/dL
350 mg/dL
Important: Read package insert
before using this product.
Store in a cool, dry place at
temperatures under 30˚C.
(86˚F). Do not refrigerate.
Replace cap immediately
and tightly.
Patents pending.
©2000 LifeScan, Inc.
AW 052-713-04B Made in U.S.A.
Milpitas, California 95035
Color Chart
The Color Chart on the test
strip bottle label shows the
approximate color of a test
strip confirmation dot for
50-mg/dL and 350-mg/dL
results. It also shows the offwhite shade of a new, unused
test strip.
Before a test, compare the
color of the confirmation dot from an
unused test strip to the “Unused” color
dot. If the confirmation dot is darker than
the color dot, do not use the test strip.
After a test, you may check the meter
result by comparing the confirmation dot
to the Color Chart. Do not use the Color
Chart as a replacement for a meter
result.
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Transferring Data
Connection Module
1 Place the meter in the
connection module
cradle.
The connection module
turns on the meter. Data
transfer occurs automatically.
INC.
2 Remove the meter from
the cradle, and press Cont if the
meter is still on.
The meter turns off automatically after
data transfer is complete. To verify a
successful upload, check the status screen
for the date and time of the last upload.
■ NOTE: If data transfer does not occur,
check the battery bar on the status screen.
Replace the batteries if the power is low.
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Serial Cable
1 Connect the serial
cable to the meter’s
serial port.
The other end of the
cable will be connected to
a workstation, modem, or
serial server. The meter
automatically turns on
and data transfer occurs.
2 Remove the serial
cable from the meter
and press Cont if the meter is still on.
The meter turns off automatically after
data transfer is complete. To verify a
successful upload, check the status
screen for the date and time of the last
upload.
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Cleaning
Cleaning the Outside of the Meter
Clean the outside of the meter with a cloth
dampened with a 10% bleach solution.
Follow with a cloth moistened with water
to remove residual bleach. Dry thoroughly.
▲ CAUTION:
Do not get water inside the
meter. Never immerse the meter or hold it
under running water because it will
damage the meter.
Cleaning the Test Strip Holder
▲ CAUTION: Do not use alcohol, glass
cleaners, or any cleansers containing
abrasives, phenol, or ammonia to clean the
test strip holder or lens area because it will
damage the meter parts.
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1 Remove the test strip holder by
pressing down on the left side and
sliding it to the right.
2 Wipe the test strip holder cover and
base with a cotton swab dampened
with a 10% bleach solution. Follow
with a swab dampened with water
to remove residual bleach.
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▲ CAUTION: Bleach residue left on the test
strip holder may lead to an error message or
an inaccurate, high result.
3 Thoroughly dry the test strip holder
with a soft cloth or lint-free tissue.
4 Wipe the lens area and contact
points with a cotton swab dampened
with a 10% bleach solution. Follow
with a swab dampened with water
to remove residual bleach.
Contact points
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5 Dry the lens area with a clean, soft
cloth or lint-free tissue. Be careful
not to scratch this area.
6 Replace the closed test strip holder
by sliding it into the meter. Push the
test strip holder until it clicks into
place.
7 Turn on the meter. If an error
appears, check to make sure you
installed the test strip holder
correctly.
8 Perform a quality control test.
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Changing the Batteries
1 Turn off the meter.
2 Press down on the battery door
latch. Lift open the door.
3 Remove all three batteries and
dispose of them according to your
institution’s guidelines.
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4 Insert three new size AA alkaline
batteries. Be sure to match the + end
of each battery with the + signs
inside the compartment.
▲ CAUTION: Do not use rechargeable batteries.
5 Replace the battery compartment
door.
6 Turn on the meter to verify power.
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Troubleshooting
The SureStepFlexx Meter displays prompts
and error messages to indicate the system
has detected a problem. These messages
help in resolving some common problems.
However, the meter cannot detect all
problems. When the meter does detect a
problem, it may not produce an error
message every time the problem occurs. In
some situations, improper use may cause
an inaccurate result without producing an
error message. Refer to the SureStepFlexx
Meter Operator’s Guide for a complete list of
error messages and precautions.
For help resolving any problem, contact
LifeScan’s Healthcare Professional Line at:
1 800 524-7226 (USA)
1 888 353-0800 (Canada)
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Error 1 Sample Application:
Cause: Meter detected problem with color of
test strip.
Solution:
1.Repeat test with new test strip and
• Apply blood to pink test square only.
• Make sure confirmation dot turns completely
blue.
• Insert test strip within 2 min of applying blood.
2.Check that sample hematocrit is within range:
adult 25–60%, neonatal 25–65%.
3.If you continue to get any error message,
obtain a laboratory result, and
• Compare color of test strip confirmation dot
to Color Chart on test strip bottle to see if
glucose level is very high or very low.
• Take appropriate steps to monitor patient
and provide medical care while awaiting
laboratory result.
4.Clean meter and repeat test with new test strip.
5.Contact LifeScan for help at 1 800 524-7226.
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Error 2 Test Strip:
Cause: Meter detected problem with test strip.
Solution:
1.Repeat test with new test strip and
• Check test strip expiration date. Do not use if
expired or beyond discard date.
• Apply sample to pink test square only.
• Make sure confirmation dot turns completely
blue.
• Wait approximately 1 min but not more than 2 min
after applying sample before inserting test strip.
• Do not alter test strips.
2.If you continue to get any error message,
obtain a laboratory result, and
• Compare color of test strip confirmation dot
to Color Chart on test strip bottle to see if
glucose level is very high or very low.
• Take appropriate steps to monitor patient
and provide medical care while awaiting
laboratory result.
3.Clean meter and repeat test with new test strip.
4.Contact LifeScan for help at 1 800 524-7226.
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Error 3 Test Strip:
Cause: Meter detected problem with position of
test strip.
Solution:
1.Clean meter, especially contact points, but
NOTE: Before cleaning, compare color of test
strip confirmation dot to Color Chart on test
strip bottle. If glucose level is very high or very
low, take appropriate steps to monitor patient
and provide medical care.
• Repeat test with new test strip.
• Do not move test strip after you insert it.
Remove test strip only when test is complete.
2.If you continue to get any error message,
obtain a laboratory result. Take appropriate
steps to monitor patient and provide medical
care while awaiting result.
3.Contact LifeScan for help at 1 800 524-7226.
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Error 4 Temperature Range:
Cause: Meter detected temperature problem.
Solution:
1.Repeat test with new test strip. Make sure
meter and test strip are at room temperature.
• Do not apply heat or cold to meter. Operating
temperature is 18°–30°C.
2.If you continue to get any error message, obtain a
laboratory result, and
• Compare color of test strip confirmation dot
to Color Chart on test strip bottle to see if
glucose level is very high or very low.
• Take appropriate steps to monitor patient
and provide medical care while awaiting
laboratory result.
3.Contact LifeScan for help at 1 800 524-7226.
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Error 5 Meter Optics:
Cause: Meter detected problem with optical
system.
Solution:
1.Clean meter, especially gray area inside test
strip holder, but
NOTE: Before cleaning, compare color of test
strip confirmation dot to Color Chart on test
strip bottle. If glucose level is very high or very
low, take appropriate steps to monitor patient
and provide medical care.
• Repeat test with new test strip.
• Make sure test strip holder is fully inserted
into meter.
• Wait for “Insert Strip” to appear on display
before inserting test strip.
2.If you continue to get any error message,
obtain a laboratory result. Take appropriate
steps to monitor patient and provide medical
care while awaiting laboratory result.
3.Contact LifeScan for help at 1 800 524-7226.
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Error 6 System Error:
Cause: Meter detected problem with electronics.
Solution:
1.Wipe contact points with cloth moistened
with water to remove residual bleach. Dry
thoroughly, but
NOTE: Before cleaning, compare color of test
strip confirmation dot to Color Chart on test
strip bottle. If glucose level is very high or very
low, take appropriate steps to monitor patient
and provide medical care.
• Repeat test with new test strip.
• Make sure test strip lot number (and code)
entered at meter matches number on test
strip bottle.
2.If you continue to get any error message,
obtain a laboratory result. Take appropriate
steps to monitor patient and provide medical
care while awaiting laboratory result.
3.Contact LifeScan for help at 1 800 524-7226.
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Insert Strip appears after you insert test
strip
Cause: Test strip not fully inserted into test strip
holder.
Solution:
Remove test strip. When “Insert Strip” appears,
firmly insert test strip into test strip holder until
it stops.
Remove Strip appears after you insert
test strip
Cause: Not enough sample on test strip, or test
strip inserted too quickly.
Solution:
Remove test strip. Check confirmation dot. If
white patches or streaks appear, not enough
sample was applied. Repeat test with new test
strip.
When “Insert Strip” appears, firmly and more
slowly insert test strip until it stops.
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Scan button does not appear on screen
Cause: Barcode scanner not installed or not
enabled, or battery power too low.
Solution:
1.Contact system administrator to enable meter’s
barcode scanner.
2.Check meter’s battery bar for adequate power.
Change meter batteries, if necessary.
3.If meter is not equipped with barcode scanner,
manually enter information using keypad.
Self-test failed: xxxx
Cause: Intermittent system check reading
fluctuation.
Solution:
1.Turn meter off and on several times.
2.Contact LifeScan at 1 800 524-7226.
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Self-test failed: 0080
Cause: Test strip holder removed, not completely
inserted, or dirty; test strip partially
inserted, or lens area dirty.
Solution:
1.Check test strip holder is properly installed.
2.Remove test strip from meter.
3.Clean test strip holder and lens area.
Upload overdue
Cause: Data transfer not performed within
specified time.
Solution:
Perform data transfer session.
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