AgaMatrix WaveSense Keynote Owner's Manual

INDEX:
1
Important Information
Blood Glucose Monitoring System
About Your WaveSense
KeyNote™ System
OWNER'S GUIDE
2

Getting Started

3

Symbols

4

Meter Basics

Manufacturer:
AgaMatrix, Inc.
5
10 Manor Parkway
Performing a
Salem, NH 03079 USA
Control Solution Test
©2004 – 2008 AgaMatrix, Inc.
All rights reserved.
6
How to Test Your
8100-01821 Rev F
Blood Glucose Level
24-Hour 7
Testing on Your Palm
Customer Service:
or Forearm
+1 (866) 906 4197
8
Meter Specifi cations
In case of emergency, contact your healthcare
9
Caring for Your Meter
professional or emergency response.
and Lancing Device
5

Performing a Control Solution Test

The WaveSense KeyNote system has 2 levels of control Write the discard date on the WaveSense Control
solution: normal and high. Select the level of control Solution bottle.
solution you want to use.
Important WaveSense Control Solution
The control solution is used to: [1] Ensure that information: [1] Use only WaveSense Control
your WaveSense KeyNote Meter and Test Strips are Solution with your WaveSense KeyNote System. [2]
working together properly. [2] Practice testing without
Always replace the cap on the control solution bottle
immediately after using. [3] Do not add water or any
having to use your own blood.
other liquid to control solution. [4] Control solution
Control solution tests should be performed tests should be performed within the system operating
when you: [1] First get your WaveSense KeyNote temperature range of 50 °F to 104 °F (10 °C to 40 °C).
Meter. [2] Begin using a new vial of WaveSense
KeyNote Test Strips. [3] Suspect that your WaveSense [1] Inserting a WaveSense KeyNote Test Strip:
KeyNote Meter or Test Strips are not working properly. Insert a new WaveSense KeyNote Test Strip into the
[4] Think your test results are not accurate. [5] Have
meter. The meter will be activated.
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
[2] Adjusting Code
fi rst opening the bottle or until the expiration date
printed on the label, whichever comes fi rst. Number: The meter
will display a test strip
IMPORTANT: Count forward 90 days from the code number. If this is
date you open a new bottle of WaveSense not the same as the code
Control Solution. This is your discard date. number printed on the
6

How to Test Your Blood Glucose Level

CAUTION: To ensure accurate results, wash your − Pull the Lancet Top
Off : Hold the lancet fi rmly in
hands with warm, soapy water and dry before
every test. Make sure there is no grease, oil or place with one hand and use
your other hand to pull off
lotion on the test site. Use lancets only once.
Do not use any lancet that has been used by the lancet top. Do not discard
another person. Interfering substances (see test the lancet top. It should be
used when discarding your
strip insert sheet for interfering substances) on
unwashed hands may lead to inaccurate results. used lancet.
[1] Preparing the WaveSense Lancing Device: − Replace Lancing Device Cap: Replace
Use the gray cap for testing on a fi ngertip and the clear the lancing device cap until it snaps into place. Be careful
not to touch the exposed needle on the lancet.
cap for testing on the palm (at the base of the thumb)
or forearm.
− Set the Lancing Level: The
WaveSense Lancing Device off ers
– Remove Lancing
Device Cap: Pull the cap 8 depth settings. Rotate the dial to
the desired setting as shown in the
off the lancing device.
depth indicator window. Level 1 is the
– Insert New Lancet: most shallow; level 8 is the deepest.
If you have never lanced before, it is
Insert a new WaveSense
Lancet fi rmly into the recommended that you start at level 3.
lancet holder cup. Pushing
the lancet into the lancet − Cock the Handle: Pull the cocking
holder cup may cock the handle out until it clicks. You may have
already cocked the handle accidentally
device; this is OK.
while inserting the lancet; this is OK. The
− Remove Test Strip from Blood Sample When − Remove the Lancet: When you have fi nished
You Hear The Beep: Your meter will beep once testing, pull off the cap from the lancing device. Replace
indicating that you should the lancet top. Extract the lancet from the lancet holder
remove the tip of the cup by pulling on the plastic collar of the lancet (near
WaveSense KeyNote Test Strip the middle of the lancet). Replace the lancing device cap
from the blood sample. until it snaps or clicks into place.
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, Discard the used WaveSense
you will hear a beep. Your test result is KeyNote Test Strip and Lancet
now stored in the memory. properly.
WARNING: The lancing
[5] Final Steps
device should only be used
− Remove the Test Strip: by one patient. Do not
Remove the used WaveSense re-use lancets.
KeyNote Test Strip. The WaveSense
KeyNote Meter will automatically
deactivate.
MEANING: Glucose test result is lower than 20 mg/dL.
Display Messages
This Lo result may indicate hypoglycemia (low blood
glucose). The Lo result is stored in the memory with
CAUTION: Low or high blood glucose test results time and date. ACTIONS: If you feel symptoms such
can indicate a potentially serious medical as weakness, sweating, nervousness, headache or
condition. Follow your healthcare professional's confusion, follow your healthcare professional's
recommendations. recommendations. If you get a Lo glucose test result
but have no symptoms of low blood glucose, then retest
The ADA (American Diabetes Association) recommends with a new WaveSense KeyNote Test Strip. If you still get
the following target ranges for adults with Diabetes: a Lo test result, follow your healthcare professional's
Pre-Prandial Plasma Glucose 90-130 mg/dL and Post- recommendations.
Prandial Plasma Glucose < 180 mg/dL. Always consult
your healthcare professional for your recommended HI MESSAGE:
target ranges. beep (if volume is enabled in SET Options) MEANING:
Glucose test result is above 600 mg/dL. This Hi result
LO MESSAGE: Flashing message, with double may indicate hyperglycemia (high blood glucose).
beep (if volume is enabled in SET Options) The Hi result is stored in the memory with time and
1
Important Information About Your WaveSense
(THIS SIDE)
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
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.
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
7
Testing on Your Palm
or Forearm
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
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
Flashing message, with double 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
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.
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.
This is the visual
Compare the result of your
fi ll window. DO
NOT PUT CONTROL
control solution test to
SOLUTION HERE.
the range printed on the
WaveSense KeyNote Test
Apply control
solution here.
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.
The entire
visual fi ll
Normal: 80-120 mg/dL
window will
High: 220-320 mg/dL
turn blue.
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
Release Button
button.
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.
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.
2
4
Getting Started Meter Basics
Unpack your WaveSense KeyNote System Kit.
METER SYSTEM CHECK
Dispose of the packing material properly.
Each time your meter is activated, the meter will
perform a meter system check.
IMPORTANT: To ensure accurate use of meter,
All display segments and the
verify the time, date and units of measure.
backlight will briefl y fl ash ON.
For step-by-step instructions on setting the time and
IMPORTANT:
date settings, please refer to section 14 "Setting Time
segments DO NOT fl ash ON (each time your
and Date."
meter is activated), do not use the meter. Call
customer service immediately.
3
Symbols HOW TO ACTIVATE THE METER AND
View Individual Results: [1] When your
The following symbols may appear on the meter is deactivated, press any button once. The
equipment packages or in the documents:
display shows the most recent test result with
time and date. [2] Press the LEFT arrow button
SN
Serial Number:
repeatedly to scroll thru every test result, starting
Manufacturer:
from the most recent and ending with the oldest.
In Vitro Diagnostic Medical Device:
V I D
Batch Code:
L O T
View Time-of- Day Averages: [1] When your
Consult Instructions For Use:
i
Do Not Reuse: meter is deactivated, press any button once. The
2
Temperature Limitation:
display shows the most recent test result with
Use By:
time and date. [2] Press the RIGHT arrow button
Catalogue Number:
repeatedly to scroll thru your Breakfast, Lunch,
Dinner, and Bedtime Averages.
Enter MENU Mode: [1] When your meter is
To deactivate the meter, remove the used WaveSense
deactivated, press and hold any button for 2 seconds
KeyNote Test Strip. Dispose of used materials properly.
to enter the MENU mode. [2] Press the RIGHT or
LEFT arrow buttons to view the options: MEM (14,
If your control solution test results are out of the range,
30 and 90 Day Averages and Graphs), SET (meter
repeat the test. If the results from the control solution
settings), and AL1 to AL6 (reminder alarms 1 thru 6).
tests continue to fall outside that range, do not use the
WaveSense KeyNote System to test your blood glucose.
Call customer service. Enter MEM (Memory) Mode to view 14, 30
and 90 Day Averages and Graphs: [1] Enter
IMPORTANT: Out-of-range test results may be the MENU mode. [2] Press the RIGHT or LEFT
caused by: [1] Expired or defective control solution.
arrow buttons until the MEM symbol is displayed.
[2] Expired or defective test strip. [3] Error in
[3] When the MEM symbol is displayed, press the
performing test. [4] Watered-down control solution.
CENTER button.
[5] Code number on WaveSense KeyNote Test Strip
vial not matching code number set in the meter. [6]
Enter SET (Settings) Mode: [1] Enter the MENU
Meter malfunction. [7] Control solution test done
mode. [2] Press the RIGHT or LEFT arrow buttons
outside the operating temperature of 50 °F to 104 °F
until the SET symbol is displayed. [3] When the SET
(10 °C to 40 °C). [8] Failure to shake the control solution
symbol is displayed, press the CENTER button.
bottle vigorously. [9] Failure to discard the fi rst drop of
control solution and to wipe the bottle tip clean.
HOW TO DEACTIVATE THE METER
To deactivate the meter, press and hold the CENTER
CAUTION: Results from control solution tests do
button for 2 seconds. If left inactive for 3 minutes,
not refl ect your blood glucose level. The control
the meter will be deactivated automatically.
solution range is a target range for control
solution only. It is not a target range for your
HOW TO ACCELERATE THROUGH OPTIONS
blood glucose level.
Hold down the RIGHT or LEFT arrow buttons to
accelerate through options or results.
− Express Blood Drop: Wipe of the WaveSense KeyNote Test Strip will turn red.
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.
IMPORTANT:
[4] Applying Blood Sample
strip from the blood sample as soon as
you hear the beep. [2] Do not press
CAUTION: Be sure not to press the RIGHT or LEFT the WaveSense KeyNote Test Strip
arrow buttons while applying blood. You might against the test site. [3] Do not scrape
accidentally change the calibration code number. blood onto the WaveSense KeyNote
Test Strip. [4] Do not apply blood to
− Bring Test Strip to Blood Sample: The meter now the top side of the WaveSense KeyNote Test Strip. [5]
displays the blood drop and test strip symbols. This means Do not apply blood to the WaveSense KeyNote Test
your WaveSense KeyNote System is now ready for you to Strip when the test strip is out of the meter. [6] Do
apply blood. Immediately bring not put blood or foreign objects into the WaveSense
KeyNote strip port. [7] Do not apply more blood after
the WaveSense KeyNote Test Strip
to the blood sample. The test strip beep. [8] Carefully read the test results on the screen
fi lls from the tip. Do not try to before making any treatment decisions.
smear blood on the top surface.
On the display, blood drop symbols appear on the
The WaveSense KeyNote Test Strip test strip symbol to indicate that blood is fi lling the
acts like a sponge and draws the WaveSense KeyNote Test Strip.
blood into the test strip through the
sample area. The visual fi ll window
8 9
Caring for Your Meter
Meter Specifi cations
and Lancing Device
Assay Method: Dynamic Electrochemistry
Maximum Altitude: 10,000 ft
When using your meter, avoid getting dirt, dust,
Calibration: Plasma equivalent
blood, control solution, water or any other liquid into
Sample: Whole blood, capillary
the strip port and battery compartment. Clean the
Sample Size: 0.5 microliters
outside of the meter or the lancing device using a
Average Glucose Test Time: 6 seconds
cloth dampened with mild detergent or mild soap.
Measurement Units: mg/dL
If you wish to clean the lancing device cap only,
Alarms: 6 programmable alarms
remove the cap, wash it in warm water, rinse well,
Result Range: 20 to 600 mg/dL
and dry.
Hematocrit: 20% to 60%
Operating Relative Humidity: Up to 90%
CAUTION:
Operating Temperature: 50 °F to 104 °F (10 °C
body of the lancing device in water or any
to 40 °C)
other liquid solution.
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)
[2] CAUSE: The batteries are installed incorrectly or
LOW BATTERY MESSAGE: Flashing message there are no batteries in the meter. ACTION: Check that
MEANING: The battery in your meter is low. ACTIONS: both batteries are installed correctly, with the positive
If the battery symbol appears, the batteries must be (+) sign facing up towards you.
[3] CAUSE: WaveSense KeyNote Test Strip has been
replaced. If the battery symbol appears, the backlight
will be disabled in all modes. 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

Troubleshooting #1

contact bars of the test strip in the meter. Ensure that
the test strip is fully inserted.
Troubleshooting Situation #1: Meter does not
[4] CAUSE: Defective meter or defective WaveSense
enter the TEST Mode after inserting a WaveSense
KeyNote Test Strips. ACTION: Call customer service.
KeyNote Test Strip.
[5] CAUSE: Blood or foreign objects put into the
WaveSense KeyNote Meter strip port. ACTION: Call
[1] CAUSE: The batteries have insuffi cient power.
customer service.
ACTION: Replace the batteries, set time and date,
and test.
If all the display
This is the visual fi ll
window. DO NOT
PUT BLOOD HERE.
Apply blood here.
[1] Remove the test
The entire
visual fi ll
window will
turn red.
Never immerse the meter or the