CERA-PET Blood glucose monitoring system Bedienungsanleitung

Blood Glucose Monitoring System
User Manual
P13110
1
Before Use
Thank you for choosing the CERA-PET™ Blood Glucose Monitoring System. This User
Guide outlines the handling precautions and correct usage procedure. Please read this
user guide in full before using the CERA-PET™ Blood Glucose Moni- toring System.
Blood glucose monitoring should be carried out with the guidance of a veterinarian/vet-
erinary surgeon/vet.
1-1. Intended Use
① The CERA-PET™ Blood Glucose Monitoring System is intended for use outside the
body only (in vitro diagnostic use).
② The CERA-PET™ Blood Glucose Monitoring System is intended for use in
monitoring
blood samples taken from dogs and cats.
③ Use only the CERA-PET™ Blood Glucose Test Strip with this test meter.
④ The CERA-PET™ Blood Glucose Test Strips are not intended for human blood
glucose
testing and may give inaccurate results when used on human blood.
⑤ For accurate testing with fresh whole blood samples (Venous, capillary blood).
⑥ Do not let the device come into contact with hot surfaces.
⑦ Do not try to disassemble, repair or remodel this device.
⑧ Severe dehydration and excessive water loss may cause false, low results.
⑨ Do not use the device if it is not working properly, or if it has suffered any damage.
⑩ Please consult with a veterinarian before use. Any change in medication, based on the
CERA-PET™ blood glucose test results, without the consent and advice of a veterinar-
ian/veterinary surgeon, is not recommended.
⑪ Do not use to diagnose diabetes without consulting your veterinarian.
⑫ If your pet's blood glucose results are higher or lower than usual but your pet does not
exhibit any unusual symptoms, repeat the test for accuracy. If your pet has symptoms
or you continue to get results higher or lower than usual, follow the treatment advice of
your pet healthcare professional.
⑬ Conduct control solution test as directed in the user guide.
1-2. Important Test Strip Information
① Keep the test strips away from direct sunlight and heat.
② Store the test strips at a temperature between 1℃~32℃ (34℉~90℉).
③ Store the test strips in their original vial only. Do not transfer them to a new vial or another
container.
④ Clean and dry your hands before removing a strip from the vial.
⑤ Close the vial cap tightly immediately after removing a test strip.
⑥ Do not bend, cut or alter test strips.
⑦ Test strips are single use only. Do not reuse.
⑧ Drying agents in test strip vial may be harmful if inhaled or swallowed.
⑨ Keep away from children. If this product is mishandled, it may cause serious harm or
injury.
※Please refer to the insert paper in your test strip package for additional impor- tant
information.
2
Table of Contents
1. Before Use 7. Before Testing
1-1. Important Safety Information 7-1. Coding the Test Meter
1-2. Important Test Strip Information 8. Testing Blood Glucose
2. Table of Contents 8-1. Getting a Drop of Blood
3. Introduction 8-2. Performing a Blood Glucose Test
3-1. Intended Use
8-3. Glucose Control Solution Test
3-2. Principle of Measurement 9. Memory
4. Contents of the System 9-1. Reviewing Results from the memory
5. Understanding the CERA-PET™ Blood 9-2. Clearing the Memory
Glucose Monitoring System 9-3. Blood Glucose Monitoring Chart
5-1. Appearance and Key Functions of 10. Transferring stored Data
11. Caring for the Test Meter and Test Strip
the Test Meter
5-2. Explanation of the Test Meter Display 11-1. Maintenance
5-3. Test Strip Description 11-2. Storage and Handling
5-4. Code Key Description 11-3. Error Message and Troubleshooting
6. Preparation Before Use 12. Specifications
6-1. Changing the Battery 13. Warranty
6-2. Test Meter Set-Up 14. Definition of Symbols
3
Introduction
The CERA-PET™ Blood Glucose Monitoring System achieves the highest standards in
accuracy, reproducibility and portability. Stored test results are easily retrievable so that
you may compare them to laboratory results with your veterinarian. This allows for better
management of your pet diabetes and periodic blood glucose testing.
Please read this user guide before using the CERA-PET™ Blood Glucose Monitoring
System.
3-1. Intended Use
The CERA-PET™ Blood Glucose Monitoring System is intended for use in veterinary and
medical professional setting to monitor blood glucose level in dogs and cats. It is also
intended for use in the home setting to monitor blood glucose levels in dogs and cats. The
CERA-PET™ Blood Glucose Monitoring System is intended for in vitro diagnostic use.
3-2. Principle of Measurement
The test is based on the measurement of an electrical current generated by the reaction of glu-
cose with the reagent of the test strip. The test meter measures the current and displays the
corresponding blood glucose level. The strength of the current produced by the reaction depends
on the amount of glucose in the blood sample.
4
Contents of System
① Test Meter ⑦ Sterile Lancet
② Lancing Device ⑧ Carrying Case
③ 3V Lithium Coin Battery ⑨ Diabetes Diary
④ User Guide ⑩ Quick Guide
⑤ Test Strips
⑪ Code Key (Dog, Cat)
⑥ Glucose Control Solution (sold
separately)
2 3 4 5 6 7
8 10
Ճ͆ झ ঈɾě ν ֨ ֟ ࢰ
5 Und erstanding the CERA-PET™ Blood Glucose
Monitoring System
5-1. Appearance and Key Functions of the Test Meter
[Front]
Indicator Light
Insert Port
The insert port is where you insert the test strips
for testing as well as the code key for calibration.
Power Button
Turn the meter ON or OFF
In Setup mode, use this button to Save the date, time,
measurement unit and alarm settings.
Display
Setting Buttons (◄►)
Recall previous test results from the meter memory.
In Setup mode, use this button to change the date, time,
measurement unit and alarm settings.
[Back]
Battery Cover
Data Port
5-2. Explanation of the Test Meter Display
Memory Symbol : Indicates a test result
stored in memory.
2
Test Result Area : Test results, code
numbers or error messages are dis-
played here.
3
Blood Drop Symbol : This symbol tells
you when to apply the sample.
Test Strip Symbol : Appears when you
need to insert a test strip.
5
Alarm Symbol : Appears when in the alarm
setting mode or when alarm is beeping.
6 Battery Symbol : Appears when the bat-
tery is low.
Code : Indicates the code number of the
test strip.
Measurement Unit : Appears with the test
result either in mg/dL or in mmol/L.
9 SET : Appears when in the setting mode.
Contact Port : Insert this end of the test strip into
the test meter. Push it in firmly until it will go no
further.
Grip : Hold this part to insert or remove the test
strip.
Confirmation Window : This is where you confirm
if enough blood has been applied to the absor-
bent hole of the test strip.
Absorbent Hole : Apply a drop of blood here.
The blood will automatically flow into the reaction
zone.
5-4. Code Key Description
When using the CERA-PET™ Blood Glucose
Monitoring System for the first time, or before
using a new box of test strips, you will need to
calibrate the test meter. There are 2 code keys in
every box of test strips; 1 for dogs ("D") and 1 for
C107
cats ("C"). Calibration can be easily done by in-
serting the relevant code key into the test meter.
6
Preparation Before Use
6-1. Changing the Battery
To replace the battery
① Make sure the meter is off before removing the battery.
② Pull the buckle on the battery cover away from the meter.
③ Remove the old battery and replace with a new 3V lithium battery (CR 2032).
Make sure that the positive( + ) side is facing up.
④ Replace the battery cover.
CAUTION
Replacing the battery will not delete test meter settings unless you
• Touch the metal wire inside the battery unit with your fingers or with another metal.
• Exceed 1 minute when replacing the battery.
• Load the battery incorrectly.
• Load a used or weak battery.
WARNING
• Keep batteries away from children's reach.
• If a battery is swallowed, please consult a doctor immediately.
NOTE
Recheck and reset the clock setting as necessary after battery replacement to ensure
time is set correctly. To set the meter clock, see Test Meter set-up on the next page.
NOTE
• To save battery power, the test meter automatically turns off after 2 minutes of
inactivity.
• When the low battery symbol appears (see section "11-3. Error Message and
Troubleshooting") with other displayed data, it means the battery is running low but
has enough power to run 20 times. It is recommended that you should replace the
battery as soon as possible. The battery symbol will only appear on its own if the
battery is too low to perform any more blood glucose tests. The meter will not
function until the battery is replaced.
• Discard old battery as per local guidelines.
6-2. Test Meter Set-Up
With your meter turned on or off, press the Power button for 3 seconds to enter the setup
mode. The meter will also enter the set-up mode when the battery is replaced. To exit
the setup mode at any stage, press the Power button for 3 seconds. The meter will save
the settings and will turn off.
IMPORTANT
Please always set the date and time before using the CERA-PET™ Blood Glucose
Monitoring System for the first time or after replacing the battery. Do not perform a
blood glucose test until you have set-up the test meter.
1) Set Year : The year will appear at the bottom of
the display. Press the Setting buttons(◄►) until the
correct year is displayed. Once you have selected
the correct year, press the Power button to save
your choice and start setting the month.
2) Set Month : Press the Setting buttons(◄►) until the correct month
is displayed. Once you have selected the correct month, press the
Power button to save your choice and start setting the date.
3) Set Date : Press the Setting buttons( ◄►) until the correct date
is displayed. Once you have selected the correct date, press the
Power button to save your choice and start setting the hour.
4) Set Hour : Press the Setting buttons(◄►) until the correct hour
is displayed. Once you have selected the correct hour, press the
Power button to save your choice and start setting the minutes.
5) Set Minute : Press the Setting buttons(◄►) until the correct minute
is displayed. Once you have selected the correct minute, press the
Power button to save your choice and move to set the alarm.
NOTE
Pressing the Setting buttons(◄►) continuously will pass the numbers quickly.
6) Set Alarm : You can set up to 5 daily alarms.Press
the Setting buttons(◄►) to choose the number
of alarms you would like to set. As you press the
Setting buttons(◄►), the display with "OFF" mes-
sage will change to the first alarm reminder '1'. If
you continue to press Setting buttons(◄►), it
adds the next alarm reminder. To save the number
of alarm reminder, press Power button.
NOTE
Default alarm times are 6:30, 9:30, 12:30, 18:30 and 21:30. You can choose from
these or set your own time.
7) Set Indicator : Press the Setting buttons(◄►) to
select to turn On or Off the Indicator light. With the
indicator On, the indicator light located on the insert
port will be blinking and vice versa. After selecting
the Indicator On or Off on the display, press the Pow-
er button to save your choice and move to set the
measurement unit.
8) Press the Setting buttons(◄►) to select the meas-
urement unit (mg/dL or mmol/L). With the correct
measurement unit on the display, press the Power
button to save your choice and finish all the settings.
IMPORTANT
Please consult with your veterinarian or veterinary surgeon about which measurement
unit is most suitable for you.
NOTE
Your test meter displays 7, 14 and 30 days average which you can access from the
test meter memory. These averages are calculated from results obtained during 7, 14
and 30 days from the current date and time settings. When you set a new date and
time, the 7, 14 and 30 day averages may change. After 2 minutes of inactivity while the
test meter is in the setting mode, it will shut down automatically.
7
Before Testing
Each batch of the CERA-PET™ Blood Glucose Test Strip comes with two code keys;
one for dogs and one for cats. The code keys are encoded with the algorithms for the
blood glucose testing for a specific pet species.
In order to ensure an accurate result, the code number on the display must also match
the code number found on the Test Strip Vial for your pet species.
7-1. Coding the Test Meter
1) With the test meter display facing you, insert the code key completely into the code
key port with the code number also facing you.
2) The code number will appear on the LCD display.
3) Make sure the code numbers and pet species on the display match the code key and
the test strip vial for dog or cat. If all of the numbers match, you may begin testing.
NOTE
1) Select the test site.
• There are many sites to obtain capillary blood samples.
cats and dogs]
• Warming the area will help increase blood flow. This can be done by:
- Gently rubbing the test site
- Applying a warm(not hot) cloth to the test site. If using a wet cloth, place the cloth
inside a plastic bag to avoid diluting the blood sample.
2) Wash your hands with warm water and soap to ensure accurate results. Thouroughly
dry your hands.
3) After selecting the test site, clean the area thoroughly removing hair and debris. To
ensure there is no dirt or debris, it may help if you shave the test site area prior to
testing.
4) Use the lancing device to obtain a blood drop.
Lancing
Device :
Lancet :
① Unscrew the cap of the lancing device and insert a lancet into the lancet holder and
push down firmly until it is fully seated.
② Twist the protective cap until it is separated from the lancet.
③ Replace the lancing device cap. Twist the adjustable tip to set the depth level. The
number lines up with the arrow: 1~2 for soft or thin skin, 3 for average skin; 4~5 for
thick or calloused skin. Generally you will need a higher setting for a dog than a cat.
④ Pull the sliding barrel until it clicks.
⑤ Press the tip of the device firmly against the desired puncture site and press the
release button. You will hear a click, indicating that the puncture is complete.
⑥ Gently squeeze the punctured area to obtain a blood sample. Once the test has
been completed, gently apply pressure to the test site with sterile gauze or cotton
wool to help stop the blood flow.
7 8
⑦
Unscrew the cap of the lancing device and push the ejection system upwards
to remove the lancet.
⑧
Place the protective cap on a hard surface and push the exposed tip into the
protective cap.
8-2. Performing a Blood Glucose Test
1) Remove a test strip from the vial and immediately close
the cap. Using your right hand, hold the glucose strip by
the "G" handle and insert the test strip fully into the insert
port of the test meter, with both the "G" handle and the
test meter display facing you.The ' ' symbol will blink on
the display.
2) The code on the LCD display must match the code num-
ber on the test strip vial.
NOTE
If you do not apply a blood sample to the test strip within 2 minutes, the test meter
will automatically shut down. You must remove and reinsert the test strip to restart the
test procedure.
3) Obtain a blood sample. Please refer to section of "8-1.Getting a drop of blood". You
should wipe away the first drop of blood with a tissue and test using the 2nd drop.
4) Apply blood to the absorbent hole of the test strip until the confirmation window is full
of blood. The test meter will begin to count down from 5 seconds and a result will be
displayed. This reading is automatically stored in the test meter.
CAUTION
The blood sample should completely fill the confirmation window in order for the countdown
to begin. If you find that the confirmation window is not completely filled when the test
meter is counting, DO NOT try to add more blood to the test strip. Discard the test strip
and retest with a new one.
8-3. Glucose Control Solution Test
CERA-PET™ Blood Glucose Control Solution contains glucose that reacts to the test
strips. By comparing the result from a control solution test with the expected range
printed on the test strip vial label, you can check that the test meter and the test strips
are working together as a system and that you are performing the test correctly. It is very
important that you do this simple check routinely to make sure you get accurate results.
Perform a Glucose Control Solution Test if
• You would like to test your system without using a blood sample.
• You suspect the test meter or test strips may not be functioning properly.
• Test results appear to be abnormally high or low or are not consistent with the symp-
toms you are experiencing.
• The test strip vial was not closed properly.
• You are using a new vial of test strips.
• You dropped the test meter
NOTE
The results obtained from Glucose Control Solution test do not indicate your pet's
glucose level.
IMPORTANT
Use the CERA-PET™ Blood Glucose Test Meter only with the CERA-PET™ Blood
Glucose Test Strips. Glucose Control Solution is sold separately. Do not use the con-
trol solution after expiration date as printed on the vial. Use the control solution within
4 months after opening. It is recommended to record the opening date on the Glucose
Control Solution vial as a reminder for when you need to dispose of the opened control
solution.
NOTE
Always close the cap on the Glucose Control Solution immediately after use.
1) Using your right hand, hold the glucose strip by the "G" handle and insert the test strip
fully into the insert port of the test meter, with both the "G" handle and the test meter
display facing you. The blood symbol will start blinking.
2) Shake the Glucose Control Solution vial thoroughly. Remove the cap and squeeze
the vial. Discard the first drop and wipe off the dispenser tip to prevent contamination.
3) Squeeze the vial to get another drop of glucose control solution and apply directly to
the absorbent hole of the test strip. The drop will be automatically drawn into the test
strip. Make sure the confirmation window is completely filled.
4) The test meter will count down from 5 seconds and then display the Glucose Control
Solution test result. Compare this result with the control solution range printed on the
test strip vial label.
WARNING
If the test result is outside the range printed on the test strip vial, repeat the test.
If you continue to have out-of-range results, it means that the system may not be
working properly. Do not use the product and please contact your local distributor for
9
assistance.
Memory
9-1. Reviewing Results from the Memory
The CERA-PET™ Blood Glucose Test Meter can store up to 1000 test records. Each
record includes the test result, time and date. The meter will also calculate the average
values of records from the last 7, 14 and 30 days.
1) Viewing Stored Records
With the meter On, press one of the Setting but-
tons(◄►) to enter memory mode. The most
recent test result and the 'memory' symbol )
will appear on the display. Press the Left arrow
button(◄) to go through the stored records. First,
you will see the test number then it will switch to
your test results with date and time.
2) Viewing data averages
NOTE
If there are already 1,000 records in the memory, the oldest record will be erased
to make room for a new one. Your most recent result will display first.
9-2. Clearing the Memory
1) When in memory mode, press and hold both
the Setting buttons (◄►) for more than 3 sec-
onds to enter the delete mode. You will see both
displays "dEL" and "ALL" switching one after
another.
2) To clear the memory, press
and hold both the Setting but-
tons(◄►) for 3 seconds. The
display will show 'memory'
) and "---", the me-
symbol (
ter will clear its memory and
turn itself off after a moment.
3) If you entered the delete mode but want to exit without deleting the stored data, press
the Power button. This will turn the meter off without deleting any data.
WARNING
Extreme caution should be used when clearing the memory. This is not a reversible
operation.
9-3. Blood Glucose Monitoring Chart
Normal Blood Glucose Level
[Source]
Home Monitoring of Blood Glucose Concentration in the
Management of Diabetes Mellitus Home, Compendium
small Animal/Exotics Vol.23. No.6 June 2001: p544~575
(Dog, Cat)
10
Transferring Stored Data
The CERA-PET™ Blood Glucose Test Meter allows the stored meter data to be transferred
to your computer. Using the CERA-PET™ blood glucose management software and USB
data transfer cable (purchased separately) you can transfer and show analytical interpreta-
tions.
1) Make sure the glucose meter is turned off. Data cannot transfer
when the device is still on.
2) After you initiate the software for blood glucose management on
the computer, you connect the transfer cable from the computer
to the glucose meter.
3) If the connection is properly carried out, the glucose meter will
display "PC" on the display screen.
NOTE
If you disable the cable during the transfer of data, the data may not transfer prop-
erly. Please keep the transfer cable intact until the transfer is completed.
4) After the data transfer is completed, you can remove the transfer cable. If you need
more details about the blood glucose monitoring software of CERA-PET™ BGMS,
please contact your local distributor.
11
Caring for your Test Meter and Test Strip
To avoid contaminating your test meter and test strips, please wash your hands and test
site with soap and water. Make sure you dry your hands and the test site thoroughly.
11-1. Maintenance
Your test meter does not require special maintenance. There is no special cleaning
required because no blood or control solution comes in contact with the test meter.
Avoid getting dirt, dust, blood, or water inside the test meter through the Insert port. A
damp cloth and mild detergent can be used to wipe the outside of the test meter.
Your test meter is a precision instrument. Please handle it with care.
11-2. Storage and Handling
1) Test Meter storage and handling
• Store test meter at -10 °C ~ 60 °C (14 °F ~ 140 °F).
• Do not leave the test meter in very hot or cold places.
• Do not leave it near a heat source or in your vehicle during adverse weather
conditions.
• Always store or carry the test meter in its original storage case.
• Avoid dropping and strong impact.
• Avoid direct sunlight and humidity.
2) Test Strip storage and handing
• Store test strips at 1 °C ~ 32 °C (34 °F ~ 90 °F), below 85 % relative humidity.
• Store your test strips in their original vial only.
• Do not transfer to other containers.
• Store test strips in a cool and dry place.
• Keep away from direct sunlight and heat.
• After taking test strips from the vial, close the vial cap immediately.
• Make sure your hands are clean and dry before touching the test strips.
• Use each test strip immediately after removing it from the vial.
• Write the disposal date on the test strip vial as a reminder to dispose of the opened
vial after 4 months.
• Do not bend, cut, or alter a test strips in any way.
• Keep the test strips away from children since the cap and the test strips may be a
choking hazard.
• If swallowed, immediately see a doctor for help.
• Follow local governing regulations and recycling plans for disposal or recycling of
device components.
11-3. Error Message and Troubleshooting
Message Possible Cause What You Should Do
Test result level is more Repeat the test with a new
than 900 mg/dL test strip. If this message shows
(50.0 mmol/L) again, please contact your veteri-
nary surgeon immediately.
Test result level is less than Repeat the test with a new test
10 mg/dL (0.6 mmol/L)
strip. If this message shows
again, please contact your veteri-
nary surgeon immediately.
Battery power is low. Prepare to replace the battery.
The battery power is too Replace the battery immediately.
low for testing.
The operating temperature Allow the test meter and test
of the system is not within strips to warm up or cool down
the recommended range slowly (30 minutes) until the
4 °C ~ 40 °C (39 °F ~ error message goes away.
104 °F).
Test strip is used. Repeat test with a new test strip.
Failure to operate during Repeat test with a new test strip.
a test.
Test strip was removed Repeat test with a new test strip.
during a test.
Damaged code key or the Re-code the Test Meter.
code key was removed
If the problem persists
during coding of the
please contact your local
meter.
distributor.
The code is not set. Insert the code key that
accompanied the box of the test
strips.
12
Specifications
• Product Name : CERA-PET™ Blood Glucose Monitoring System
• Model : G 300 V
• Sample Type : Fresh whole blood from capillary and venous in dogs and cats
• Sample Size : 0.5 ㎕
• Hematocrit Range : 10 % ~ 70 %
• Test Time : 5 seconds
• Dimensions : 53.6 x 94 x 13.9 (mm)
• Weight : 35 g
• Power source : One CR2032 3V lithium coin battery
• Altitudes up to 4,000m (13,200ft)
• Measurement Range : 10~900 mg/dL (0.6~50 mmol/L)
• Storage/Transport Condition : -10°C~60°C (14°F~140°F)
(Blood Glucose Test Meter) below 85% relative humidity, 700 to 1,060 hPa)
13
Warranty
The manufacturer, GREEN CROSS MEDIS Corp., guarantees the CERA-PET™ Blood
Glucose Monitoring System to be free of defects in material and workmanship for a
period of 3 years.
This guarantee is valid from the date of purchase. The guarantee extends only to the
original purchaser and is not transferable.
14
Definition of Symbols
Symbol Reference
In vitro disgnostic medical device
Do not reuse
Consult instructions for use
Temperature limitation
Use by
Date of manufacture
Batch code
Manufacturer
Serial Number
Power Button
Do not dispose of the instrument with your normal waste
Caution, consult accompanying documents
Direct current
My pet's Information
1. Name :
2. Species : □ Dog □ Cat
3. Breed :
4. Gender : □ Female □ Male
5. Age :
6. Diabetic : □ Yes □ No
7. Pet Owner's Name :
8. Phone :
9. Veterinary Clinic's Name :
10. Clinic's Contact :
11. Average Blood Glucose Level :
12. Insulin shot : □ Yes □ No