WaveSense KeyNote System Owner's Manual

INDEX: (THIS SIDE)

10 About the WaveSense™

KeyNote™ System

11 Time-of-Day Averages and

Individual Results

12 View 14, 30, and 90 Day

Averages and Graphs

13 Setting Meter Volume

and Backlight

14 Setting Time and Date
15 Setting Hypoglycemic and

Hyperglycemic Warning
Alarms

16 Setting Alarms
17 Batteries
18 Important Health-Related

Information

10

About the WaveSense™ KeyNote™ System

Your WaveSense™ KeyNote™ System includes:

size, 0.5 µl of blood, about the size of a pinhead.

- WaveSense™ KeyNote™ Blood Glucose Meter

- Two pre-installed CR2032, 3 volt, lithium batteries

- Lancing Device with Gray Cap

- Clear AST Lancing Device Cap

WARNING: The test strip vial contains drying
agents that may be harmful if inhaled or
swallowed and may cause skin or eye irritation.

- 10 Lancets (33 Gauge)

- Compact Carrying Case

CAUTION: Discard used test strips properly.

- Control Solution

- Owner’s Guide

IMPORTANT: Use WaveSense™ KeyNote™ Test Strips

only once.

About the WaveSense™ KeyNote™ Test Strip:
With your WaveSense™ KeyNote™ System, you can
test your blood glucose on your  ngertips, palms (at
the base of the thumb), and forearms. Testing with the
WaveSense™ KeyNote™ System requires a small sample

Important Test Strip Information:

[1] Store the WaveSense™ KeyNote™ Test Strip vial in
a cool, dry place at 46 °F to 86 °F (8 °C to 30 °C). [2]
Use WaveSense™ KeyNote™ Test Strips only within the
system operating temperature range of 50 °F to 104 °F
(10 °C to 40 °C ). [3] Keep away from direct sunlight and
heat. [4] Store your WaveSense™ KeyNote™ Test Strips
in their original vial only; never store them in another

Contact Bars: Insert
this end, facing up, into
the meter’s strip port.

Sample Area: Apply
blood or control solution
to the edge of the test
strip here.

Visual Fill Window:

The window will turn
red when enough
blood has been applied
or blue when enough
control solution has
been applied.

vial, any other container or outside the vial. [5] After
removing an WaveSense™ KeyNote™ Test Strip from the
vial, immediately close the vial cap tightly. [6] With
clean, dry hands, you may gently handle the WaveSense™
KeyNote™ Test Strip when removing it from the vial or
inserting it into the meter. [7] Do not use WaveSense™
KeyNote™ Test Strips beyond the expiration date or 90

days after  rst opening the vial. This may cause inaccurate
results. Write the discard date (90 days from the  rst
opening) on the test strip vial. [8] Do not bend, cut, or
alter WaveSense™ KeyNote™ Test Strips. [9] Apply only
fresh capillary blood or control solution to the sample area
of the WaveSense™ KeyNote™ Test Strip.

About the WaveSense™ KeyNote™ Meter

3

4

1

2

5

(1) Display: Glucose test results, symbols, messages,

and graphs appear here. (2) CENTER Button: Use the
CENTER button to con rm an option or make a selection
in a menu. (3) RIGHT Arrow Button: Use the RIGHT
arrow button to scroll forward through options. (4)
Strip Port: Insert the WaveSense™ KeyNote™ Test Strip,
with the contact bars facing up, into the strip port. (5)
LEFT Arrow Button: Use the LEFT arrow button to scroll
backward through options.

About the WaveSense™ KeyNote™ Meter Display
Segments

(1) Date and Time (2) Glucose Test Results (3) Low

Battery: appears when the batteries in your meter are

running low. (4)Temperature Symbol: appears when
the meter is outside its operating temperature range of 50
°F to 104 °F (10 °C to 40 °C ). (5) Code Symbol: appears
when displaying the code number of the test strip. (6)
Ketone Symbol: appears when your glucose test results
are higher than 240 mg/dL (13.3 mmol/L). (7) Control
Solution Symbol: appears after you have performed
a control solution test. (8) Units of Measurement:
Results will be displayed in mg/dL.

7

16

:

3

4

mmg l/dL

13

12

AM

PM

8

11

1
2

15

3

1

9

14

5

Ket one

6

14

30

90

co de

2

co ntr ol

10

(9) Apply Sample to Test Strip: The test strip symbol

and  ashing droplet symbol will signal you to apply
sample to the test strip. (10) Sample Entering Test
Strip: The three droplet symbols will appear within the
test strip symbol when blood or control solution enters

the test strip. (11) High Volume: large bell indicates
high volume. (12) Low Volume: small bell indicates
low volume. (13) Volume OFF: small bell with a
line across it indicates mute. (14) 14, 30, and 90
Day Indicators: The appropriate number of days will
appear when viewing graphical averages. (15) 1,2,3
Countdown: The 1, 2 and 3 symbols will appear during
a test. (16) Graphing Area: Areas of the dot matrix
will appear during a test and when displaying graphs.

About the WaveSense™ KeyNote™ Lancing
System

2

1

5

3

4

8

6

7

(1) Cocking Handle: Cocks the device so it is ready to

lance. (2) Depth Adjustment Dial: Adjusts how deep
the lancet will lance the skin. (3) Depth Indicator
Window: Displays the depth setting of the lancing
device. (4) Release Button: Fires the lancet. (5)

Lancet: Lances the skin to produce a drop of blood. (6)
Lancet Cap: Covers the lancet for safety. (7) Lancing
Device Cap: Covers the lancet when in lancing device.

(8) Alternate Site Testing Cap: Used for obtaining a

blood sample on the palm (at the base of the thumb).

11 T

ime-of-Day Averages and Individual Results

This section covers the steps on how to view
your:

Press the RIGHT arrow button. The

display now shows your lunch averag e.
– Most Recent Glucose Test Result
– 300 Past Glucose Test Results, with time and date
– Breakfast, Lunch, Dinner and Bedtime Averages

Press the RIGHT arrow button. The

display now shows your dinner

average.
The WaveSense™ KeyNote™ Meter calculates averages
of all the test results during breakfast, lunch, dinner
and bedtime. Control solution, Hi and Lo test results,

Press the RIGHT arrow button. The dis-

play now shows your bedtime average.
out-of-temperature-range results, and results without
a valid date / time are not included in the averages.
Averages are composed of results only within the

Note: To return to the most recent test

result, press CENTER but ton.

last 14 days. Breakfast averages include glucose
measurements between 4:00 am and 10:00 am, lunch
averages are between 10:00 am and 4:00 pm, dinner
averages are between 4:00 pm and 10:00 pm, and
bedtime averages are between10:00 pm and 4:00 am.

[2] Viewing Individual Results

Press and release the CENTER button.

The display will show the most recent

glucose test result with the time and

date.Use the LEFT arrow button to

[1] Viewing Time-of-Day Averages

Press any but ton once when the meter is

view every test result, starting from

the most recent and ending with the oldest.
OFF. The display shows the most recent
glucose test result with the time
and date. Press the RIGHT arrow

Note: At any point, press CENTER button to return to

the most recent test result .

button. The display now shows
your breakfast average.

View 14, 30, and 90 Day Averages and Graphs

12

This section covers the steps on how to view

button to enter the Memory option.

your:

– 14 Day Numerical Average and Trend Graph
– 30 Day Numerical Average and Trend Graph
– 90 Day Numerical Average and Trend Graph

Note: Use the RIGHT or LEFT arrow
buttons to scroll through the MENU
Mode options.

– 14, 30, and 90 Day Averages Comparison Graph

The WaveSense™ KeyNote™ Meter calculates the
averages from the last 14, 30 and 90 days, starting from

mg /dL

the current time and date shown on the meter. Control
solution, Hi and Lo test results, out-of-temperature­range results, and results without a valid time / date
are not included in the averages.

[3] Viewing MEMORY Test Results

− View 14 Day Averages and Graphs: The display

shows your 14 day numerical average. Press the RIGHT or
LEFT arrow buttons to view your 14 day trend graph.

IMPORTANT: Results stored in memory should

only be used as a reference. Do not make
treatment decisions based solely on stored
results. Consult with your physician regarding
treatment options.

You can move from the 14
day trend graph to the 14
day numerical average by
pressing the RIGHT or LEFT
arrow buttons.

[1] Enter MENU Mode

Press and hold any button for 2 seconds to enter the
MENU mode.

− View 30 Day Averages and Graphs: Press the
CENTER button to view your 30 day numerical average.
Press the RIGHT or LEFT arrow buttons to view your 30

[2] Enter Memory Option

day trend graph.

When the MEM symbol appears, press the CENTER

The number o f glucose test resu lts
saved(with in the time perio d) is
displayed i n the top right corne r.

mg/dL

14

You can move from the 30
day trend graph to the 30
day numerical average by
pressing the RIGHT or LEFT

mg/dL

30

arrow buttons.

− View 90 Day Averages and Graphs:
Press the CENTER button to view your 90 day numerical
average. Press the RIGHT or LEFT arrow buttons to view
your 90 day trend graph.

You can move from the 90
day trend graph to the 90
day numerical average by
pressing the RIGHT or LEFT
arrow buttons.

mg/dL

90

− View14, 30, and 90 Day Average
Comparison Graph: Press CENTER button

to view your 14, 30, and 90 day average
comparison graph. The display shows an
overview with three trend bars comparing

14

30

90

the 14, 30, and 90 days averages.

One dot represents 50 mg/dL (2.8 mmol/L).

One dot represents 20 mg/dL (1.1 mmol/L).

Setting Meter Volume

13

and Backlight

[1] Enter MENU Mode: When your meter is OFF,
press and hold any button for 2 seconds to enter the
MENU mode.

[2] Enter SET Option: The MEM
symbol will appear. Press the RIGHT
arrow button until the SET symbol is
displayed. Press the CENTER button.

[3] Setting Meter Volume: There
are three beep volume options. The default set ting
is “high.” Select the preferred volume setting with
the RIGHT or LEFT arrow buttons. Your selection
will be highlighted by the blinking of the symbol.
Press the CENTER button to con rm
your selection. Continue to set the
MENU Mode Backlight option.

[4] Setting Backlight
Option: You can enable or disable the backlight.

The default setting for the backlight is enabled. The
changed status of the backlight will be activated
immediately.

Select the preferred setting with the

RIGHT or LEFT arrow buttons. Press

the CENTER button to con rm and

continue on to set the Time Format and Time.

Note: Disabling the backlight in the SET menu also

disables backlight for alarms.

Setting Time and Date

14

[1] Enter MENU Mode: When your meter is OFF,
press and hold any button for 2 seconds to enter the
MENU mode.

[2] Enter SET Option: The MEM
symbol will appear. Press the RIGHT
arrow button until the SET symbol is
displayed. Press the CENTER button.

[3] Setting Time: Press CENTER
repeatedly until you see a screen with
the message 12H or 24H, you are ready
to set the meter’s time.

Select a 12 or 24 hour clock format with the RIGHT or

LEFT arrow buttons.

The 12 hour clock display option is indicated by a 12H.
The 24 hour clock display option is indicated by a 24H.
Your selection will be highlighted by the blinking of
the symbol.

Press the CENTER button to con rm your selection and
move on to the hour setting.

Set the hour ( ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to con rm and
continue on to set the minute.

Hour:

Set the minute ( ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to con rm and
continue on to set the date.

Minute:

[4] Setting Date: Set the month ( ashing) with
the RIGHT or LEFT arrow buttons. Press the CENTER

:

PM

button to con rm and continue on to the day
setting.

Month:

Set the day ( ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to con rm and

move on the year setting.

Day:

Set the year ( ashing) with the RIGHT or LEFT arrow
buttons. Press the CENTER button to con rm and
continue on to set the Hypo Limit.

Year:

:

PM

Setting Hypoglycemic

15

and Hyperglycemic
Warning Alarms

:

PM

[1] Enter MENU Mode: When your meter is OFF,
press and hold any button for 2 seconds to enter the
MENU mode.

[2] Enter SET Option: The MEM symbol will appear.

[3] Setting Your Hypoglycemic Warning

Alarm: Press CENTER repeatedly until you see the
HYPO symbol in the top right corner of the screen. You
are ready to set the Hypoglycemic Warning Alarm.

The Hypoglycemic Warning Alarm alerts you when your
glucose test results are below the hypoglycemic limit
that you have set. The meter is pre-set to a hypoglycemic
limit of 70 mg/dL. Always consult your physician for
your recommended target ranges. When your glucose
test results are below your set hypoglycemic limit, the
date, time and result will  ash on
the display.

Set the Hypoglycemic Limit ON or

mg/dL

OFF with the RIGHT or LEFT arrow
buttons. Your selection will be highlighted by the
blinking of the symbol. Press the CENTER button to
con rm your selection.

Set the Hypoglycemic Limit ( ashing)
with the RIGHT or LEFT arrow
buttons. Press CENTER button to

mg/dL

con rm and continue on to set the
Hyper Limit.

[4] Setting Your Hyperglycemic
Warning Alarm: The Hyperglycemic Warning Alarm

alerts you when your glucose test results are above the
hyperglycemic limit that you have set. The meter is pre-set
to a hyperglycemic limit of 240 mg/dL. Always consult your
physician for your recommended target ranges. When your
glucose test results are above your set
hyperglycemic limit, the date, time and
result will  ash on the display.

mg/dL

Set the Hyperglycemic Limit ON or OFF
with the RIGHT or LEFT arrow buttons.
Your selection will be highlighted
by the blinking of the symbol. Press
CENTER button to con rm your
selection.

mg /dL

Set the Hyperglycemic Limit ( ashing)
with the RIGHT or LEFT arrow buttons.
Press CENTER button to con rm. This will bring you back
to MENU Mode at the SET options.

CAUTION: Consult your physician for a

recommendation on your hyperglycemic limit.

Press the RIGHT arrow button until the SET symbol is
displayed. Press the CENTER button.

CAUTION: Consult your physician for a

recommendation on your hypoglycemic limit.

Setting Alarms

16

There are 6 alarms you can set to remind you
when to test your glucose levels.

When alarms are activated: [1] If an alarm
is set and the WaveSense™ KeyNote™ Meter is
turned OFF, the alarm will turn the meter ON.
“AL1” thru “AL6” (depending which alarm is set)
is displayed. The display backlight  ashes, and
the meter will beep repeatedly for 15 seconds.
[2] You can turn the alarm OFF by pressing any
button. [3] The alarms will not appear during
Menu and Test Modes. If an alarm is set to go
o when using these modes, it will be activated
after the meter is turned OFF.

CAUTION: Follow your physician’s

recommendations on when and how often
to test your glucose.

[1] Enter MENU Mode: When your meter is

OFF, press and hold any button for 2 seconds to
enter the MENU mode.

[2] Enter Alarm Option: The MEM symbol
appears. Press the RIGHT or LEFT arrow buttons

until the alarm you want to set is

displayed (AL1 to AL6). If this is your

 rst time setting an alarm, use AL1.

Press CENTER to select an alarm

to set.

[3] Turning Alarms ON or OFF: Press the

RIGHT or LEFT arrow buttons to

enable (ON) or disable (OFF) the

:

alarm. The default setting is OFF.

Con rm your selection by pressing

CENTER button. Your selections

will be highlighted by a blinking

symbol.

[4] Setting Alarm Times: You can now set the

time. First, set the  ashing numbers (hour) with

the RIGHT or LEFT arrow buttons.

:

Accelerated change is possible by

holding down the arrow buttons.

Press CENTER to con rm and to

move on to set the minute.

:

Set (minute) with the RIGHT or

LEFT arrow buttons. Press the

CENTER button to con rm the

alarm time and to move on to set

the alarm volume.

[5] Setting Alarm Volumes: There are
three volume options. A silent alarm will only
 ash the meter’s screen. The default setting is
“high”. Select your preferred
setting with the RIGHT or LEFT
arrow buttons. Con rm by

PM

pressing the CENTER button.
This will bring you back to MENU
Mode.

Note: The volume of an alarm will be a ected by
the meter’s volume set ting, which can be changed
in the meter’s settings (SET) option. If your meter is
set to silent mode, then the alarm will not sound,
regardless of the individual alarm set ting. Also, if

PM

your meter is set to low volume mode, then an alarm
set for high volume will default to low volume mode.

[6] Setting Multiple Alarms: To set other

alarms, press the RIGHT or LEFT arrow buttons

PM

until the alarm you want to set (AL1 to AL6)
is displayed. Follow the previous steps in this
section 16, “Setting Alarms.”

17

Batteries

CAUTION: When the battery symbol appears,

you should replace the batteries immediately.
Only use CR2032 batteries.

:

PM

Your WaveSense™ KeyNote™ Meter comes with two
pre-installed, CR2032, 3 volt, lithium batteries. If your
batteries run low, the battery symbol  ashes until
you change the batteries. The backlight is disabled
in all modes when the battery symbol is on. When
changing batteries the current time and date settings
will be reset. The time and date will automatically
be set to 01-01 12:00. Correct time and date set tings
are needed to get correct averages. Removing the
batteries does not a ect the meter’s memory or
previously stored user settings, such as those set in
SET Options (e.g. calibration code, alarms, etc.).

[2]Remove and Install 1st Battery: To remove
the used battery, use a non-metallic tool at point A to
pop out the battery. Install the
new battery with the positive
(+) sign facing up towards you.

Used:

New:

A

A

results. If you believe you are su ering from severe
dehydration, consult your physician immediately.
[2] The ADA (American Diabetes Association) recom­mends the following target ranges for adults with
Diabetes: Pre-Prandial Plasma Glucose 90-130 mg/dL
(5.0-7.2 mmol/L) and Post-Prandial Plasma Glucose
< 180 mg/dL (< 10.0 mmol/L). Always consult your
physician for your recommended target ranges. [3]

[3]Remove and Install
2nd Battery: Repeat previous step

for the 2nd battery.

Results below 70 mg/dL (3.9 mmol/L) may mean low
blood glucose levels (hypoglycemia). [4] Results
over 240 mg/dL (13.3 mmol/L) may mean high blood

glucose levels (hyperglycemia). Checking ketones may
[4]Close Battery Door: Angle
the battery door back onto the
meter and swing down until it
snaps gently into place. Make sure
that the battery door is completely
closed before using.

be advisable. [5] If you get results below 70 mg/dL

(3.9 mmol/L) or above 240 mg/dL (13.3 mmol/L)

and do not have symptoms of hypoglycemia or

hyperglycemia, repeat the test. If you have symptoms,

or continue to get results that fall below 70 mg/dL

(3.9 mmol/L) or rise above 240 mg/dL (13.3 mmol/L),

follow your physician’s recommendations. [6] If you

Replacing the Batteries

[1]Open Battery Door: Make
sure the meter is powered OFF. Turn
the meter so you are looking at the
battery door. Press the battery door
clip to open. Remove the battery
door. Be careful not to misplace the
battery door.

Important Health-

18

Related Information

Please Read the Following: [1] Severe dehydra-

tion and excessive water loss may yield inaccurate

are experiencing symptoms that are not consistent

with your blood glucose test and you have followed all

instructions described in the WaveSense™ KeyNote™

Owner’s Guide, follow your physician’s recommenda-

tions. [7] Patients undergoing oxygen therapy may

receive inaccurate results. [8] Always follow your

physician’s recommendations.

Error Messages

The WaveSense™ KeyNote™ Blood Glucose Monitoring
System has been designed to work accurately under
most usual conditions. On rare occasions, the meter will
display an error message instead of a glucose result. The
WaveSense™ KeyNote™ system is able to detect speci c
problems which may allow you to determine the cause of
the error without wasting valuable test strips. When you

are presented with an error message, check for common
problems that may explain the source of the error.

Two common errors are listed below:

[1] The meter may return an error code if it is being used
near electrical equipment, like a power generator or a
computer monitor. [2] If the meter rattles when shaken,

there may be a broken component which may cause error
messages. In this case call customer service.

Error 1: Problems have occurred that are
related to test strip use.

[1] If this message appears the moment the test strip is
inserted, the test strip may be wet or damaged. [2] If the
message appears during a test, the test strip may have
been removed too early. [3] If this message appears after
the last progress bar instead of a result, it may indicate
that you applied more blood after testing began.

Error 2: The meter has detected an irregularity
with the sample.

[1] The test strip may be partially  lled; you should check
the window of the test strip to con rm that it is full. [2] The
sample may not be blood or control solution. [3] You may

have entered the wrong calibration code.

Error 3: The meter has detected that the test
strip is in poor condition.

[1] The test strip may have been improperly stored (e.g.
hot, humid conditions) or may be expired. [2] The test
strip may have been mishandled by vigorous bending
or shaking. [3] Parts of the test strip may have become
covered in grease, oil, or lotion. [4] The strip port
connector may be dirty.

Error 4: Unusual test strip problems have
occurred that may be related to extreme conditions.

[1] Retest where it is closer to a room temperature of
70 °F to 75 °F (21 °C to 24 °C).

Error 5: The meter was unable to produce a
reliable result.

[1] This may be caused by a non-blood sample, or
a combination of high glucose and other medical
conditions. [2] If this error code persists on retesting,
consult your physician.

Error 6: The test strip has taken too long to
generate a signal.

[1] This may be caused by a combination of cold
operating temperature and high hematocrit levels. Retest
in a warmer location. [2] If this error code persists on
retesting, consult you physician.

Error 7 with Battery Icon:

Replace batteries immediately before testing.

Error 7:

Meter problems have occurred that are beyond your
control. Contact customer service for assistance.

Troubleshooting #2

Troubleshooting Situation #2:

The glucose test sequence does not start after
applying the blood sample.

[1] CAUSE: Defective test strip. ACTION: Repeat the
test with a new WaveSense™ KeyNote™ Test Strip. If
this does not work, call customer service.
[2] CAUSE: Sample applied after meter times out
and turns OFF. ACTION: Repeat the test using a new

WaveSense™ KeyNote™ Test Strip. Wait until you see
the blood and test strip symbols on the display screen
before you apply the blood sample.
[3] CAUSE: Defective meter. ACTION: Call customer
service.

Customer Service:

[phone]