Palmdoc Palmdoc I User manual

Let me be your guide.

1
Welcome to

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01. Before you begin..............................................4
02. Getting to know your system.....................9
03. Blood glucose test strips usage
– instructions for use.....................................19
04. Prepare for blood sampling......................23
05. Performing blood test ................................28
06. Understanding your test result ...............36
07. Comparing with laboratory results .......37
08. Memory recall .................................................39
09. Control solution testing..............................41
10. Caring for your meter and test strip ....46
11. About alternative site testing (AST) .....48
12. Display messages and
problem-solving guide ................................50
13. Performance characteristics .....................54
14. System specifications...................................56
PageContents

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01. Before you begin
The following basic safety precautions should
always be taken.
1. Close supervision is necessary when the
device is used by, on, or near children, or
disabled people.
2. Use the device only for the intended use
described in this User Guide.
3. Do not use test strips and control
solutions which are not supplied by
the manufacturer.
4. Do not use the device if it is not working
properly, or if it has suffered any damage.
5. Before using any product to test your blood
glucose, read all instructions thoroughly
and practise the test. Do all quality control
checks as directed and consult a diabetes
healthcare professional.
6. Keep this guide handy.
Intended use
The system is intended for use outside
the body (for self testing, in vitro diagnostic
use only). It should be used only for testing
blood glucose (blood sugar) and only with a
01. Before you begin

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fresh capillary whole blood sample. The system
is intended for use in the home and in clinical
settings. It should not be used for the diagnosis
of diabetes or for the testing of newborns.
Principle of measurement
Blood glucose is measured by an electrical
current that is produced when a blood sample
mixes with the reagent (special chemical) of the
test strip. The electrical current changes with
the amount of glucose in the blood sample.
The PalmDoc I meter measures the strength
of the electrical current, calculates your blood
glucose level and then displays your result
in mmol/L.
Caution
1. Do not make any decision of medical
relevance without rst consulting your
medical practitioner.
2. Call your doctor immediately if you
experience symptoms that are not consistent
with your blood glucose test results.
3. Altitudes above 3,402 metres (11,161ft) may
affect the test results.
4. Temperatures outside the range of 10°C
to 40°C (50°F to 104°F) may affect the
test results. Do not use the system to test
outside of this temperature range.
01. Before you begin

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5. Do not use this meter near cellular or
cordless telephones in a call, walkie-talkies,
garage door openers, radio transmitters, or
other electrical or electronic equipment that
are sources of electromagnetic, radiation,
as these may interfere with the proper
operation of the meter.
6. Servicing or maintenance is not allowed
while the meter is in use.
7. No modication of this meter is allowed.
Important health-related information
1. Apply only capillary whole blood samples
to test your blood glucose. Applying other
substances, plasma or serum will cause
incorrect results.
2. Severe dehydration and excessive water
loss may cause false low results. If you
believe you are suffering from severe
dehydration, consult your healthcare
professional immediately.
3. Test results below 3.3 mmol/L*1 indicate
low blood glucose (hypoglycemia). Test
results greater than 13.3 mmol/L*2 indicate
high blood glucose (hyperglycemia). If
your results are below 3.3 mmol/L or above
13.3 mmol/L, repeat the test. If the results
are still below 3.3 mmol/L or above 13.3
01. Before you begin

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mmol/L, consult your healthcare professional
immediately.
4. Inaccurate results may occur in severely
hypotensive individuals or patients in
shock. Inaccurate low results may occur for
individuals experiencing a hyperglycemic-
hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested
with blood glucose meters.
5. Interference: Reducing substances occurring
in the blood naturally (uric acid, bilirubin)
or from therapeutic treatments (ascorbic
acid, acetaminophen) will not signicantly
affect the PalmDoc I test results. However,
elevated concentrations of these substances
may affect test results. The compounds
listed in the table overleaf were found
to have no effect at the concentration
indicated.
01. Before you begin

801. Before you begin
Acetaminophen
Ascorbic Acid
Aspirin
Bilirubin
Cholesterol
Creatinine
Dopamine
Galactose
EDTA
Glutathione
Haemoglobin
Heparin
Gentisic Acid
0.53 mmol/L
0.28 mmol/L
3.33 mmol/L
1.54 mmol/L
12.9 mmol/L
0.44 mmol/L
0.11 mmol/L
50 mmol/L
12.3 mmol/L
1.72 mmol/L
0.08 mmol/L
8,000 U/dL
0.32 mmol/L
Hydroxyurea
L-dopa
Maltose
Methyldopa
Tolbutamide
Triglycerides
Uric Acid
Ibuprofen
Icodextrin
Pralidoxime Iodide
Salicylate
Tolazamide
Xylose
Compounds Compounds
Concentrations higher than
the following values may
cause inaccurate results
Concentrations higher than
the following values may
cause inaccurate results
0.39 mmol/L
0.51 mmol/L
26.3 mmol/L
0.13 mmol/L
14.8 mmol/L
22.6 mmol/L
0.48 mmol/L
2.42 mmol/L
0.01 mmol/L
0.94 mmol/L
4.34 mmol/L
3.21 mmol/L
6.66 mmol/L

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02. Getting to know your system
The PalmDoc I uses the latest technology
to provide you with easy and comfortable
testing. The system requires only a 0.5 μL of
blood sample to complete the testing in only
5 seconds.
The PalmDoc I system consists of:
1. PalmDoc I blood glucose meter
2. Blood glucose test strips
3. Sterile tip lancets
4. Soft feel travel bag
5. Control solution (not included)
Reference:
1: Kahn, R. and Weir, G.: Joslinis Diabetes Mellitus,13th
ed Philadelphia: Lea and Febiger (1994), 489.
2: Krall, L.P. and Beaser, R. S.: Joslin Diabetes Manual.
Philadelphia: Lea and Febiger(1989), 261-263.
02. Getting to know your system
For In vitro diagnostic use Keep dry
Keep away from sunlight
Humidity limitation
Sterilized using
irradiation
Lot number
Do not reuse
Use by/Expiry date
Manufacturer
Temperature limitation/Store at
EU representative
This blood glucose meter, test
strips, and control solution full
the requirements of Directive
98/79/EC on in vitro diagnostic
medical devices
The lancet fulls the
requirements of Directive
93/42/EEC on medical devices
Caution, consult accompanying
document
Consult instructions for use

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The visual display
1. Battery symbol: Appears when the battery
is weak and should be replaced.
2. Thermometer symbol: Appears when the
ambient temperature is above or below the
acceptable range needed for testing.
3. Memory symbol: Appears when in
memory mode.
4. Teststrip symbol: Appears when the meter
awaits the insertion of a test strip.
02. Getting to know your system
Important:
Use only PalmDoc Blood Glucose Test Strips
and Control Solutions with your PalmDoc
Blood Glucose Meter. Use of other test strips
and control solutions with this meter can
produce inaccurate results.

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5. Blood drop symbol: Flashes when the
meter and test strip are ready for the
application of the blood sample.
6. Measurement unit: Appears with the test
result.
7. Average: Appears when the meter is in
memory mode while recalling 7/15/30/45/90
day test averages.
02. Getting to know your system
Day Month Year Hour Minute
1 2 3 4 5 6 7

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Setting button
Each button has a
unique function.
Strip slot
Holds a PalmDoc blood
glucose test strip in
place when you perform
a blood glucose test.
Display
Shows test results
and messages. Meter label
Each meter has a
unique serial number
on it. Do not alter or
tear the label o.
Battery
compartment
Holds one 3V lithium
battery (battery
type CR2032).
The meter
02. Getting to know your system

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The setting button
Button
Press to enter time
and date setting mode.
Button
Press and hold for 2 seconds
to turn meter on and off.
Button
Press to decrease the value
of the current setting.
Button
Press to increase the value
of the current setting.
Button
Press to enter
memory recall mode.
Button
While in the setting mode, press
to exit and return to test display.
02. Getting to know your system

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Setting time and date
Your PalmDoc I meter comes with a new battery
(battery type CR2032). Please set the correct
time and date before you begin to test.
1. Press BUTTON for 2 seconds to turn
on the meter.
2. After you hear the buzzer, press
BUTTON to enter the time setting mode.
3. The day will ash.
4. Press or BUTTON to obtain the desired
day and press BUTTON to conrm and
move next to the MONTH setting.
5. Repeat to set the month, year, hour and
minute. After the minute setting is set, the
display returns to the day setting. Press
the “OK” BUTTON to nish and exit time
setting mode.
Note:
You can exit the time setting mode at
anytime by pressing the “OK” button while
you set the time and date.
Setting measuring unit
The PalmDoc I meters supplied to the UK and
Europe are all pre-set unit of measurement to
mmol/L. The measurement unit is unable to be
changed by the users. It can only be set in the
02. Getting to know your system

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factory.
When you turn off the meter or replace the
battery, the unit will not be changed.
Use of the wrong unit of measure may cause
misinterpretation of your blood glucose level,
and may lead to incorrect treatment. Please
always consult your healthcare professional
rst if you want to reset the unit of measure,
or contact us for help.
Replacing the battery
The meter comes with ONE lithium battery
(battery type CR2032). Battery life will vary
depending on usage. The battery should last
about 1,000 tests or 12 months when testing
3 times a day.
When the battery symbol appears on the meter
display, the battery charge is low. You will still
be able to test with a low battery, but you
should replace it as soon as possible.
When the battery symbol is ashing on the
meter display, the meter will no longer give
results and you must replace the battery
immediately. Always have a spare battery with
you to ensure that you can replace the battery
at anytime.
02. Getting to know your system

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How to replace the battery
1. Make sure the meter is turned off. Let the
front of the meter rest in the palm of your
hand. Slide the battery cover open.
2. Use the edge of the battery cover to pull
out the battery from the holder.
02. Getting to know your system

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3. Insert a new battery (battery type CR2032),
making sure to align the plus (+) side up.
4. You should hear a beep to indicate correct
installation. If not, please reinsert the battery
correctly, then close cover.
02. Getting to know your system
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Note:
1. Replacing the battery does not affect
the test results stored in memory;
however, the time and date may need
to be re-set.
2. As with all small objects, the battery
should be kept away from small children
as a safety precaution. If the battery
is swallowed, seek medical assistance
immediately.
3. Batteries might leak chemicals if not
used for a long time. Remove the
batteries if you are not going to use
the device for an extended period
(i.e. 3 months or more).
4. Please discard the used or dead
batteries properly according to the
regulations of your country.
02. Getting to know your system