− Remove the Lancet:
When you have fi nished
testing, pull off the cap from the lancing device. Replace
the lancet top. Extract the lancet from the lancet holder
cup by pulling on the plastic collar of the lancet (near
the middle of the lancet). Replace the lancing device cap
until it snaps or clicks into place.
Discard the used WaveSense
KeyNote Test Strip and Lancet
properly.
WARNING:
The lancing
device should only be used
by one patient. Do not
re-use lancets.
− Remove Test Strip from Blood Sample When
You Hear The Beep:
Your meter will beep once
indicating that you should
remove the tip of the
WaveSense KeyNote Test Strip
from the blood sample.
The moving dot bar indicates
that your blood glucose test is
in progress.
Your test is completed when your
blood glucose test result with time
and date is shown on the display. If
the volume is enabled in SET Options,
you will hear a beep. Your test result is
now stored in the memory.
[5]
Final Steps
− Remove the Test Strip:
Remove the used WaveSense
KeyNote Test Strip. The WaveSense
KeyNote Meter will automatically
deactivate.
of the WaveSense KeyNote Test Strip will turn red.
IMPORTANT:
[1]
Remove the test
strip from the blood sample as soon as
you hear the beep.
[2]
Do not press
the WaveSense KeyNote Test Strip
against the test site.
[3]
Do not scrape
blood onto the WaveSense KeyNote
Test Strip.
[4]
Do not apply blood to
the top side of the WaveSense KeyNote Test Strip.
[5]
Do not apply blood to the WaveSense KeyNote Test
Strip when the test strip is out of the meter.
[6]
Do
not put blood or foreign objects into the WaveSense
KeyNote strip port.
[7]
Do not apply more blood after
beep.
[8]
Carefully read the test results on the screen
before making any treatment decisions.
On the display, blood drop symbols appear on the
test strip symbol to indicate that blood is fi lling the
WaveSense KeyNote Test Strip.
− Express Blood Drop:
Wipe
away the fi rst blood drop that
appears using a clean tissue or
paper towel. Squeeze from the
base of your fi nger up towards
the tip, until a second small blood
drop forms. Do not squeeze directly
around the lanced area.
[4]
Applying Blood Sample
CAUTION:
Be sure not to press the RIGHT or LEFT
arrow buttons while applying blood. You might
accidentally change the calibration code number.
− Bring Test Strip to Blood Sample:
The meter now
displays the blood drop and test strip symbols. This means
your WaveSense KeyNote System is now ready for you to
apply blood. Immediately bring
the WaveSense KeyNote Test Strip
to the blood sample.
The test strip
fi lls from the tip. Do not try to
smear blood on the top surface.
The WaveSense KeyNote Test Strip
acts like a sponge and draws the
blood into the test strip through the
sample area. The visual fi ll window
number as printed on the test strip vial. The meter now
displays the blood drop and
test strip symbols.
The WaveSense KeyNote
System is now ready for you to apply blood.
Note:
You can still change the code number as long as
you have not applied blood to the WaveSense KeyNote
Test Strip by pressing the LEFT and RIGHT arrow buttons.
[3]
Lancing
− Lance Test Site:
To ensure accurate results, wash
hands with warm, soapy water and dry before every
glucose test.
For details on possible test sites, refer
to section 1, “Important Information About Your
WaveSense KeyNote System.”
For instructions on how to test on your palm or
forearm, please refer to section 7, “Testing On Your
Palm or Forearm.”
Note:
Keep your hand warm or gently massage the site
you are lancing to stimulate blood fl ow.
Press the lancing device
against the site to be
lanced. Press the release
button.
CAUTION:
To ensure accurate results, wash your
hands with warm, soapy water and dry before
every test. Make sure there is no grease, oil or
lotion on the test site. Use lancets only once.
Do not use any lancet that has been used by
another person. Interfering substances (see test
strip insert sheet for interfering substances) on
unwashed hands may lead to inaccurate results.
[1]
Preparing the WaveSense Lancing Device:
Use the gray cap for testing on a fi ngertip and the clear
cap for testing on the palm (at the base of the thumb)
or forearm.
– Remove Lancing
Device Cap:
Pull the cap
off the lancing device.
– Insert New Lancet:
Insert a new WaveSense
Lancet fi rmly into the
lancet holder cup. Pushing
the lancet into the lancet
holder cup may cock the
device; this is OK.
On the WaveSense KeyNote Meter display, droplet symbols
appear on the test strip symbol to indicate that the control
solution is fi lling the WaveSense KeyNote Test Strip.
Your meter will beep once indicating that you should
remove the tip of the WaveSense KeyNote Test Strip from
the control solution sample.
[4]
Viewing Control Solution Test Result:
The
result will appear on the display screen and, if the volume
is enabled, your meter will beep once. The word “control”
will also appear on the display screen.
Compare the result of your
control solution test to
the range printed on the
WaveSense KeyNote Test
Strip vial label for the control
solution level (normal or high)
that you used. Your control solution result
should fall within this range. The control
solution test result is stored in memory.
test strip vial, press the LEFT or RIGHT buttons until the
meter displays the same code number as printed on the
test strip vial.
[3]
Applying Control Solution:
Shake the control
solution bottle. Discard the fi rst drop of control solution
and wipe the bottle tip clean using
a clean tissue or paper towel.
Dispense a second drop onto a
clean surface, such as an unused
resealable plastic bag. Bring the
tip of the test strip to the control solution sample. The
WaveSense KeyNote System will automatically detect if a
test is performed with WaveSense Control Solution.
When control solution is applied, the visual fi ll window
on the WaveSense KeyNote Test Strip turns blue.
Write the discard date on the WaveSense Control
Solution bottle.
Important WaveSense Control Solution
information:
[1]
Use only WaveSense Control
Solution with your WaveSense KeyNote System.
[2]
Always replace the cap on the control solution bottle
immediately after using.
[3]
Do not add water or any
other liquid to control solution.
[4]
Control solution
tests should be performed within the system operating
temperature range of 50 °F to 104 °F (10 °C to 40 °C).
[1]
Inserting a WaveSense KeyNote Test Strip:
Insert a new WaveSense KeyNote Test Strip into the
meter. The meter will be activated.
[2]
Adjusting Code
Number:
The meter
will display a test strip
code number. If this is
not the same as the code
number printed on the
in SET Options)
MEANING:
If the Hyperglycemic Warning
Alarm is set, your glucose test result is higher than the
pre-set limit.
KETONE MESSAGE:
Flashing message,
with double beep (if volume is enabled in SET Options)
MEANING:
The result of the glucose test is higher than
240 mg/dL.
ACTIONS:
You should check ketones. Follow
your healthcare professional’s recommendations.
TEMPERATURE MESSAGE:
Flashing message, with
double beep (if volume is enabled in SET Options)
MEANING:
The test has been performed outside the
operating temperature range.
ACTIONS:
Move to an area
with an ambient temperature of 50 °F to 104 °F (10 °C
to 40 °C). Wait for the meter and test strips to reach the
new temperature (usually 10-20 minutes) and retest.
MEANING:
Glucose test result is lower than 20 mg/dL.
This Lo result may indicate hypoglycemia (low blood
glucose). The Lo result is stored in the memory with
time and date.
ACTIONS:
If you feel symptoms such
as weakness, sweating, nervousness, headache or
confusion, follow your healthcare professional’s
recommendations.
If you get a Lo glucose test result
but have no symptoms of low blood glucose, then retest
with a new WaveSense KeyNote Test Strip. If you still get
a Lo test result, follow your healthcare professional’s
recommendations.
HI MESSAGE:
Flashing message, with double
beep (if volume is enabled in SET Options)
MEANING:
Glucose test result is above 600 mg/dL. This Hi result
may indicate hyperglycemia (high blood glucose).
The Hi result is stored in the memory with time and
CAUTION:
Low or high blood glucose test results
can indicate a potentially serious medical
condition. Follow your healthcare professional’s
recommendations.
The ADA (American Diabetes Association) recommends
the following target ranges for adults with Diabetes:
Pre-Prandial Plasma Glucose 90-130 mg/dL and Post-
Prandial Plasma Glucose < 180 mg/dL. Always consult
your healthcare professional for your recommended
target ranges.
LO MESSAGE:
Flashing message, with double
beep (if volume is enabled in SET Options)
LOW BATTERY MESSAGE:
Flashing message
MEANING:
The battery in your meter is low.
ACTIONS:
If the battery symbol appears, the batteries must be
replaced. If the battery symbol appears, the backlight
will be disabled in all modes.
Troubleshooting #1
Troubleshooting Situation #1:
Meter does not
enter the TEST Mode after inserting a WaveSense
KeyNote Test Strip.
[1]
CAUSE:
The batteries have insuffi cient power.
ACTION:
Replace the batteries, set time and date,
and test.
date.
ACTIONS:
If you feel symptoms such as fatigue,
thirst, excessive urination, or blurry vision, follow your
healthcare professional’s recommendations.
If you get a
Hi glucose test result but have no symptoms of high blood
glucose, then retest with a new WaveSense KeyNote Test
Strip. If you still get a Hi glucose test result, follow your
healthcare professional’s recommendations. Checking
ketones may be advisable.
HYPOGLYCEMIC WARNING ALARM:
Test result fl ashes, with double beep (if volume is enabled
in SET Options)
MEANING:
If the Hypoglycemic Warning
Alarm is set, your glucose test result is lower than the
pre-set limit.
HYPERGLYCEMIC WARNING ALARM:
Test result fl ashes, with double beep (if volume is enabled
[2]
CAUSE:
The batteries are installed incorrectly or
there are no batteries in the meter.
ACTION:
Check that
both batteries are installed correctly, with the positive
(+) sign facing up towards you.
[3]
CAUSE:
WaveSense KeyNote Test Strip has been
inserted upside down, wrong end in, or incompletely
inserted into the meter.
ACTION:
Insert the WaveSense
KeyNote Test Strip with the black side up and the
contact bars of the test strip in the meter. Ensure that
the test strip is fully inserted.
[4]
CAUSE:
Defective meter or defective WaveSense
KeyNote Test Strips.
ACTION:
Call customer service.
[5]
CAUSE:
Blood or foreign objects put into the
WaveSense KeyNote Meter strip port.
ACTION:
Call
customer service.
©2004 – 2008 AgaMatrix, Inc.
All rights reserved.
8100-01821 Rev F
Blood Glucose Monitoring System
OWNER’S GUIDE
Display Messages
INDEX:
(THIS SIDE)
1
Important Information
About Your WaveSense
KeyNote™ System
2
Getting Started
3
Symbols
4
Meter Basics
5
Performing a
Control Solution Test
6
How to Test Your
Blood Glucose Level
7
Testing on Your Palm
or Forearm
8
Meter Specifi cations
9
Caring for Your Meter
and Lancing Device
4
Meter Basics
METER SYSTEM CHECK
Each time your meter is activated, the meter will
perform a meter system check.
All display segments and the
backlight will briefl y fl ash ON.
IMPORTANT:
If all the display
segments DO NOT fl ash ON (each time your
meter is activated), do not use the meter. Call
customer service immediately.
HOW TO ACTIVATE THE METER AND
View Individual Results:
[1]
When your
meter is deactivated, press any button once. The
display shows the most recent test result with
time and date.
[2]
Press the LEFT arrow button
repeatedly to scroll thru every test result, starting
from the most recent and ending with the oldest.
View Time-of- Day Averages:
[1]
When your
meter is deactivated, press any button once. The
display shows the most recent test result with
time and date.
[2]
Press the RIGHT arrow button
repeatedly to scroll thru your Breakfast, Lunch,
Dinner, and Bedtime Averages.
Enter MENU Mode:
[1]
When your meter is
deactivated, press and hold any button for 2 seconds
to enter the MENU mode.
[2]
Press the RIGHT or
LEFT arrow buttons to view the options: MEM (14,
30 and 90 Day Averages and Graphs), SET (meter
settings), and AL1 to AL6 (reminder alarms 1 thru 6).
Enter MEM (Memory) Mode
to view 14, 30
and 90 Day Averages and Graphs
:
[1]
Enter
the MENU mode.
[2]
Press the RIGHT or LEFT
arrow buttons until the MEM symbol is displayed.
[3]
When the MEM symbol is displayed, press the
CENTER button.
Enter SET (Settings) Mode:
[1]
Enter the MENU
mode.
[2]
Press the RIGHT or LEFT arrow buttons
until the SET symbol is displayed.
[3]
When the SET
symbol is displayed, press the CENTER button.
HOW TO DEACTIVATE THE METER
To deactivate the meter, press and hold the CENTER
button for 2 seconds. If left inactive for 3 minutes,
the meter will be deactivated automatically.
HOW TO ACCELERATE THROUGH OPTIONS
Hold down the RIGHT or LEFT arrow buttons to
accelerate through options or results.
2
Getting Started
Unpack your WaveSense KeyNote System Kit.
Dispose of the packing material properly.
IMPORTANT:
To ensure accurate use of meter,
verify the time, date and units of measure.
For step-by-step instructions on setting the time and
date settings, please refer to section 14 “Setting Time
and Date.”
Serial Number:
Manufacturer:
In Vitro
Diagnostic Medical Device:
Batch Code:
Consult Instructions For Use:
Do Not Reuse:
Temperature Limitation:
Use By:
Catalogue Number:
SN
D
V
I
i
2
T
O
L
3
Symbols
5
Performing a Control Solution Test
The WaveSense KeyNote system has 2 levels of control
solution: normal and high. Select the level of control
solution you want to use.
The control solution is used to:
[1]
Ensure that
your WaveSense KeyNote Meter and Test Strips are
working together properly.
[2]
Practice testing without
having to use your own blood.
Control solution tests should be performed
when you:
[1]
First get your WaveSense KeyNote
Meter.
[2]
Begin using a new vial of WaveSense
KeyNote Test Strips.
[3]
Suspect that your WaveSense
KeyNote Meter or Test Strips are not working properly.
[4]
Think your test results are not accurate.
[5]
Have
dropped or damaged your meter or exposed your meter
to liquids other than blood samples.
[6]
Are advised by
your healthcare professional to do so.
Control solution should only be used for 90 days after
fi rst opening the bottle or until the expiration date
printed on the label, whichever comes fi rst.
IMPORTANT:
Count forward 90 days from the
date you open a new bottle of WaveSense
Control Solution. This is your discard date.
Normal: 80-120 mg/dL
High: 220-320 mg/dL
lancing device is now ready for use.
[2]
Calibrating Your WaveSense KeyNote Meter
− Insert a WaveSense KeyNote Test Strip:
Insert a
new WaveSense KeyNote Test Strip into the meter.
Make sure you insert the test strip, with the contact bars
facing up, into the strip port. The meter will be activated
automatically.
Note:
If you do not start the test within 3 minutes, the
meter deactivates. To reactivate your meter, take out
the unused WaveSense KeyNote Test Strip and reinsert
it into the meter.
− Adjust Code Number:
The meter
displays a pre-set test strip code
number for 2 seconds. If this is not the
same as the code number
printed on the test strip
vial, press the LEFT or RIGHT
buttons until the meter
displays the same code
− Pull the Lancet Top
Off :
Hold the lancet fi rmly in
place with one hand and use
your other hand to pull off
the lancet top. Do not discard
the lancet top. It should be
used when discarding your
used lancet.
− Replace Lancing Device Cap:
Replace
the lancing device cap until it snaps into place. Be careful
not to touch the exposed needle on the lancet.
− Set the Lancing Level:
The
WaveSense Lancing Device off ers
8 depth settings. Rotate the dial to
the desired setting as shown in the
depth indicator window. Level 1 is the
most shallow; level 8 is the deepest.
If you have never lanced before, it is
recommended that you start at level 3.
− Cock the Handle:
Pull the cocking
handle out until it clicks. You may have
already cocked the handle accidentally
while inserting the lancet; this is OK. The
6
How to Test Your Blood Glucose Level
The entire
visual fi ll
window will
turn red.
1
area that you will be testing. Ensure that your palm or
forearm is facing up and held level.
[3]
Lance Test Site:
Press the tip of the clear cap
against your skin on the palm of your hand (at the base
of the thumb) or forearm. Hold the tip to the test site for
a few seconds before pressing the release button.
[4]
Express Blood Drop:
After lancing, hold the
lancing device against your skin until a blood droplet
forms. Do not squeeze directly around the lanced area.
Make sure the blood drop is large enough to completely
fi ll the visual fi ll window of the test strip. Pull the
lancing device directly off your palm or forearm to
ensure that you do not smear the blood drop. Return to
section 6, step 4 to continue with testing instructions.
Testing glucose levels with blood obtained from the
palm (at the base of the thumb) or forearm may reduce
the pain of testing. The technique for testing on the
palm and forearm is slightly diff erent than testing
on the fi nger. Always discuss changes to your testing
habits with your healthcare professional.
IMPORTANT:
When testing on the palm (at the
base of the thumb) or forearm, you may need
to set the lancing device to a deeper setting
or use a larger lancet to obtain enough blood
to perform a test. Consult your healthcare
professional for a recommendation.
[1]
Prepare the Lancing Device:
Replace the gray
lancing device cap with the clear cap.
[2]
Rub Test Site:
To increase the blood fl ow in your
palm (at the base of the thumb) or forearm, rub the
7
Testing on Your Palm
or Forearm
When using your meter, avoid getting dirt, dust,
blood, control solution, water or any other liquid into
the strip port and battery compartment. Clean the
outside of the meter or the lancing device using a
cloth dampened with mild detergent or mild soap.
If you wish to clean the lancing device cap only,
remove the cap, wash it in warm water, rinse well,
and dry.
CAUTION:
Never immerse the meter or the
body of the lancing device in water or any
other liquid solution.
9
8
Meter Specifi cations
Assay Method:
Dynamic Electrochemistry
Maximum Altitude:
10,000 ft
Calibration:
Plasma equivalent
Sample:
Whole blood, capillary
Sample Size:
0.5 microliters
Average Glucose Test Time:
6 seconds
Measurement Units:
mg/dL
Alarms:
6 programmable alarms
Result Range:
20 to 600 mg/dL
Hematocrit:
20% to 60%
Operating Relative Humidity:
Up to 90%
Operating Temperature:
50 °F to 104 °F (10 °C
to 40 °C)
Test Strip Storage Temperature:
46 °F to 86 °F
(8 °C to 30 °C)
Memory:
300 blood glucose and control solution
test results with date, time, and averaging (14, 30
and 90 days and time-of-day)
Power Source:
Two CR2032, 3 volt, lithium
batteries, replaceable
Automatic Shutoff :
3 minutes after last user action
Size:
Width 1.6” x Length 2.8” x Height 0.6”
(4.4 cm x 7.7 cm x 1.6 cm)
Weight:
44.1 g (including batteries)
24-Hour
Customer Service:
+1 (866) 906 4197
Manufacturer:
AgaMatrix, Inc.
10 Manor Parkway
Salem, NH 03079 USA
This is the visual
fi ll window. DO
NOT PUT CONTROL
SOLUTION HERE.
Apply control
solution here.
The entire
visual fi ll
window will
turn blue.
This is the visual fi ll
window. DO NOT
PUT BLOOD HERE.
Apply blood here.
Important Information About Your WaveSense
KeyNote System
The WaveSense KeyNote System should be
used:
[1]
For measuring blood glucose levels from fresh
capillary whole blood samples taken from the fi ngertips,
palms (at the base of the thumb), or forearms.
[2]
With
WaveSense KeyNote Test Strips and WaveSense Control
Solution only. Use with other unapproved test strips or
control solution will void the manufacturer’s warranty
and will lead to inaccurate results.
[3]
Outside of the
body (i.e.,
in vitro
diagnostic use only).
Do not use the WaveSense KeyNote System for:
[1]
The diagnosis of diabetes.
[2]
Testing the glucose
levels of neonates.
[3]
Testing glucose levels of arterial
or venous blood.
[4]
Testing glucose from sites other
than the fi ngertip, palm (at the base of
the thumb), or forearm.
Possible test sites:
The WaveSense
KeyNote System requires
only 0.5 μL of blood to
perform a glucose test.
For the best results, test
glucose from the tips of
any fi nger. The palm (at
the base of the thumb) and forearm are
alternate, but less accurate, test sites. Only select soft
and fl eshy areas to lance. Avoid lancing any bony areas,
obvious veins and moles. Physiological diff erences in
circulation between the fi ngertip, palm (at the base of the
thumb), and forearm may result in diff erences in blood
glucose measurements between these sites. Diff erences
in glucose concentrations may be observed after eating,
taking insulin medication, or exercise. Changes in blood
glucose may be detected in the fi ngertips before the palm
(at the base of the thumb) and forearm.
It is recommended that you use a fi ngertip
sample if:
[1]
You are testing for hypoglycemia or if
you suff er from hypoglycemia unawareness,
[2]
You are
testing your blood glucose within 2 hours of eating, taking
insulin, diabetes pills, exercise, or
[3]
Your blood glucose
results obtained from the palm (at the base of the thumb)
or forearm are not consistent with the way you feel.
CAUTION:
Please read all the instructions
provided in this owner’s guide and practice the
testing procedures before using the WaveSense
KeyNote Blood Glucose Monitoring System. Blood
glucose monitoring should be done under the
guidance of a healthcare professional.
The following symbols may appear on the
equipment packages or in the documents:
To deactivate the meter, remove the used WaveSense
KeyNote Test Strip. Dispose of used materials properly.
If your control solution test results are out of the range,
repeat the test. If the results from the control solution
tests continue to fall outside that range, do not use the
WaveSense KeyNote System to test your blood glucose.
Call customer service.
IMPORTANT:
Out-of-range test results may be
caused by:
[1]
Expired or defective control solution.
[2]
Expired or defective test strip.
[3]
Error in
performing test.
[4]
Watered-down control solution.
[5]
Code number on WaveSense KeyNote Test Strip
vial not matching code number set in the meter.
[6]
Meter malfunction.
[7]
Control solution test done
outside the operating temperature of 50 °F to 104 °F
(10 °C to 40 °C).
[8]
Failure to shake the control solution
bottle vigorously.
[9]
Failure to discard the fi rst drop of
control solution and to wipe the bottle tip clean.
CAUTION:
Results from control solution tests do
not refl ect your blood glucose level. The control
solution range is a target range for control
solution only. It is not a target range for your
blood glucose level.
Caring for Your Meter
and Lancing Device
In case of emergency, contact your healthcare
professional or emergency response.
Release Button
