HUMMINGBIRD MEDICAL Oracle User manual

USER GUIDE
6268RO-M01A1

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)
Preparing for Testing
7. Installing the Battery
8. Settings (
9. 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
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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.

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2. Introduction to the System
Intended Use / Indications for Use
The Oracle Blood Glucose Monitoring System is for use in the
quantitative measurement of glucose in fresh capillary whole
blood from the finger and the forearm. It is intended for use
by healthcare professionals and people with diabetes mellitus at
home and as an aid in monitoring the effectiveness of a diabetes
control program. The Oracle 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.
Some models of this system contain a speaking function that an
audible message of test results for users with low vision.
Contents of the System
This User Guide has been prepared to describe the proper use
of the Oracle Blood Glucose Monitoring System.
Please read this User Guide and the package insert that comes
with the Oracle Glucose Test Strips before testing. The
system is available either as a meter alone or as a kit. If you
have a meter only, you can purchase the system supplies from
your system provider. Please provide your system provider
with the 3 digit system reference number marked on the
packaging box when you purchase supplies.

The starter kit for Oracle Blood Glucose Monitoring System
includes the following items:
1.Oracle Glucose Meter with 2 AAA batteries
2.User Guide
3.Log Book
4.Carrying Case
5.Oracle Glucose Test Strips
6.Oracle Control Solution (Medium)
7.Sterile Lancets
8.Lancing Device
9.Package Inserts for Test Strips, Control Solution,
and Lancets/Lancing Device
The Oracle Glucose Meter uses Oracle Glucose Test Strips. Neither
the meter nor the test strips will work when used with any other brand
of glucose products.
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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 - Guides 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 - For voice-enabled models only.
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)
3. Appearance and key functions
of the meter

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4. Alternate Site Testing (AST)
What is AST?
Sampling from anatomical sites (parts of the body) other than
the fingertip (i.e. forearm, upper arm, thigh, calf, palm) 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 ?
It is more painful to take a blood sample from fingertips
because fingertips have more nerve endings. Other body sites
do not have as many nerve endings, so blood samples in
less pain.
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 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.

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Testing Procedure for AST
1.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
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.
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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 and a blinking blood
drop icon appears on the LCD
screen.
9.Press and hold the loaded lancing
device against the forearm for a few
seconds, then press and release the
button.
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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 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.
12. Remove the used strip by hand
or by pushing the ejector button. The
meter will turn off automatically.

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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 instructions thoroughly and practice the test
when you first use this system. Do a quality check on
the system by following the instructions and consult
with 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.
Use only Oracle test strips and control solutions with
the Oracle meter.
Keep the test strip vial away from children. The test
strips and vial cap can present a choking hazard.
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 properly.
Test your blood glucose using the meter and the test
strips with the same reference number as labeled on
the outer box of meter and the test strips.

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6. Quick Testing Instructions
1.With meter off, insert a new test
strip with the contacts facing up in
the test strip slot. The meter will turn
on. You will see a full screen display
briefly, and then a blinking blood
drop icon will appear on the screen.
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.
4.Remove the used strips by hand or
by pushing the ejector and the meter
will power off, with “OFF” appearing
on the screen.
(For detailed instructions start on page 16 for Control
and page for Blood Testing.) 18
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7. Installing the battery
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1.Turn off the meter by pressing the
“M”button and hold for 2 seconds
before replacing the batteries.
Open the battery cover on the
back of the meter by hand or by
pushing the tab in the direction
of the arrow and pulling the
cover up.
2.Remove the 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 and snap closed.
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Note:
1.It is suggested that batteries be replaced
when the battery icon appears empty.
With continued use 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.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.Dispose of batteries according to your
local ordinances.

8. Settings (Date / Time / Alarm / Memory Deletion )
1.Appears with the test result either in mg/dL 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 current displayed result is an average.
8.Appears when alarm is on.
9.Month
10.Day
11.Hour
12.Minute
(1)Measurement Units
(6)Battery Symbol
(3)Setting
(2)Memory
(9)Month
(10)Day (11)Hour
(12)Minute
The LCD screen will show as below:
(4)Test flag
(5)Blood drop icon
(7)Day Average
(8)Alarm
Reminder
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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.

1.Set the Year - Press the 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 displayed in the range of
2009 to 2029.
After the year setting is confirmed, you
will see the month segment flashing on
the screen.
2.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
flashing on the screen.
3.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
flashing on the LCD screen.
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:
1-01~01 01
AM
SETSET
2
:
12-01~0101
AM
SETSET
3
:
12-18~0101
AM
SETSET

4.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
flashing on the screen.
5.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.
6.Set the Alarm Reminder - Press
the C key to toggle between the alarm
reminder setting or no-setting mode.
If you see the LCD display a small
flashing icon of an 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 the M key to confirm the alarm setting mode. If you
select the alarm setting mode, the alarm clock icon will stop
flashing and the hour of the time segment will start flashing.
Press the C key until the desired alarm hour appears and then
press the M key to confirm the hour setting. Then the minute
segment will start flashing. Press the C key until the desired
minute appears on the screen and then press the M key to
confirm the minute setting. You will see the measuring
unit flashing on the upper left corner of the LCD display.
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4
:
12-18~1101
PM
SETSET
:
12-18~1125
PM
SETSET
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6
:
0800
AM
SETSET

7.Set the measurement unit -
Press the C key to toggle between
mg/dL and mmol/L
measurement units. Press the M key
to confirm the setting. You will
see a “dEL” displayed in the center
of the screen. The unit of
measurement -mg/dL- is the standard
unit of measurement in the U.S. If
the meter is to be sold in the U.S., the
units of measure will be set to mg/dL
by default.
8.Delete Memory - Press the C key
to toggle between a flashing
“dEL” for memory deletion or a
non-flashing “dEL”. If you want to
delete all memory, press the M key
while the “dEL” is flashing. If you
do not want to delete all memory,
press the M key when the “dEL” is not
flashing. Once the M key is pressed
the LCD will display “OFF” and
turn off automatically after 2 seconds .
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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 year, month, day, hour, minutes,
alarm, unit, and dEL 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.
Note: Your meter can show results either in “mg/dL” or
“mmol/L”units. It is very important to use the correct unit
of measurement to properly manage your diabetes.
If you live in the USA you should use mg/dL; your results will never
have a decimal point. If you live in Canada and some European
countries you should use mmol/L; your results will always have a
decimal point. The mg/dL display is on by default.
9.Power off Screen- When the meter
is off, the time, date, measurement
unit, and battery icon will still be on
the screen as Figure 9 shows. If the
alarm reminder has been set, then
the alarm icon will appear on the
power off screen as well. The LCD
screen will display “OFF”. 9
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9.Running a Control Solution Test
IMPORTANT:
Always make sure you press the 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 the screen, indicating the control
test mode. 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.
4.Wait for 6 seconds, and the meter will
display the result.
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.
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1.Insert a strip into the meter. A full
LCD screen will be displayed briefly and
then a blood drop icon appears.
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IMPORTANT!
1.You must push 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.)
2. Use only Oracle Control Solution with Oracle Glucose
Meter.
3.Oracle 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.Oracle Control Solution contains a known amount
of glucose that reacts with test strips. The Medium and
High Level Control Solutions 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.
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10.Running a Blood Glucose Test
1.Unscrew the lancing device
by turning the end cap counter
clockwise.
2.Insert a new lancet firmly into
the lancet holder.
3.Twist off the protective tip of
the lancet.
4.Close the end cap of the lancing
device as shown. Slide into
locking position.
5.Wash your hands in warm,
soapy water. Be sure to rinse and
dry well.
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