Palmdoc PalmDoc II User manual

Let me be your guide.
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Owner’s Manual
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Owner’s Manual
Dear PalmDoc II Meter Owner:
Thank you for choosing the PalmDoc II meter as your
blood glucose monitoring system. Please read this
manual carefully as it contains important information
about your new PalmDoc II system. A warranty
registration card is included with your system.
PalmDoc II meters are designed to help you and your
healthcare professionals monitor your blood glucose
levels. This owner’s manual will help you learn how to
use your PalmDoc II meter effectively. All questions
concerning test results should be directed to your
healthcare professional.
PalmDoc II meters have the latest technology for
blood glucose monitoring and are made with quality
components. PalmDoc II meters are easy to use, give
you fast, accurate test results with a minimal sample of
blood, have large, easy-to-read display screens, and are
lightweight and portable for your convenience.
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Owner’s Manual
PalmDoc II meters:
• Require No Coding, allowing you to save time
and avoid human error due to improper coding.
• Allow you to perform Alternate Site Testing (AST).
• Have memory and data management capabilities.
PalmDoc’s software gives you and your healthcare
professionals powerful graphic tools to manage
your diabetes.
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Owner’s Manual
Table of Contents
Letter to Meter Owner..................................................2-3
Table of Contents ..........................................................4-5
Important Safety Instructions......................................6-8
Important Health-Related Information................... 9-10
Alternate Site Testing (AST)....................................11-13
About PalmDoc Test Strips .....................................14-16
Key Functions of the Test Strip................................. 14
Important Test Strip Information........................ 15-16
Introduction to PalmDoc II Meters ........................17-18
Intended Use.............................................................. 17
Test Principle ........................................................ 17-18
Contents of the PalmDoc II Meter ...............................18
Setting up the PalmDoc II Meter ...........................19-26
Key Functions of the Meter....................................... 19
Meter Display ...................................................... 20-21
Speaking Function..................................................... 22
Setup Steps........................................................... 23-26
Control Solution Testing..........................................27-34
Performing a Control Solution Test .................. 30-34
Performing a Blood Glucose Test ..........................35-41
Preparing the Lancing Device............................ 35-36
Getting a Blood Sample ..................................... 37-38
Applying Blood to the Test Strip........................ 39-41
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Owner’s Manual
Using the Meter Memory........................................42-44
Specications..................................................................45
Caring for your PalmDoc II Meter..........................46-50
Cleaning your System ............................................... 46
Lancing Device .......................................................... 46
Disinfecting your System .................................... 46-47
Storing your System .................................................. 47
Battery ........................................................................ 48
Low Battery ........................................................... 48-49
Battery Replacement........................................... 49-50
System Troubleshooting .........................................51-57
Special Messages ................................................ 51-52
Error Messages .................................................... 52-53
Troubleshooting Guide....................................... 54-57
Information About your PalmDoc II Meter...........58-60
Comparing Meter and Laboratory Results....... 58-60
Performance Characteristics .................................... 60
Symbols Information .....................................................63
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Owner’s Manual
Important Safety Instructions
Read this before using your PalmDoc II meter. The
following basic safety precautions should always
be taken.
• For self-testing only.
• For in vitro diagnostic use only.
• Your PalmDoc II meter, PalmDoc test strips,
lancets and lancing device are for single
patient use only. Do not share them with
anyone, including other family members. Do
not use on multiple patients.
• Close supervision is necessary when the
device is used by, on, or near children,
handicapped persons or invalids.
• Use the device only for the intended use
described in this manual.
• Do not use the device if it is not working
properly, or if it has suffered any damage.
• Before using any product to test your blood
glucose, read all instructions thoroughly
and practice the test. Do all quality control
checks as directed and consult with a
diabetes healthcare professional.
• All parts of this kit are considered
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Owner’s Manual
biohazardous and can potentially transmit
infectious diseases, even after you have
performed cleaning and disinfection.
• These devices are intended to be used for
patient self-monitoring and should not be
used to collect blood from more than one
person as this poses a risk of transmitting
blood-borne pathogens such as Hepatitis B
or HIV.
• No modication of this equipment is
allowed.
• Please discard the product or the
batteries properly according to the
regulations of your country.
• Do not use this meter near cellular or
cordless telephones, walkie talkies, garage
door openers, radio trancimitters, or other
electrical or electronical equipment that
are sources of electromagnetic, radiation,
as these may interfere with the proper
operation of the meter.
For further information, please refer to:
“FDA Public Health Notication: Use of Fingerstick
Devices on More than One Person Poses Risk
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Owner’s Manual
for Transmitting Blood-borne Pathogens: Initial
Communication” (2010) http://www.fda.gov/
MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick
Devices on More than One Person Poses Risk
for Transmitting Blood-borne Pathogens” (2011)
http://cdc.gov/injectionsafety/Fingerstick-
DevicesBGM.html
DO NOT CHANGE YOUR TREATMENT BASED ON A
SINGLE RESULT THAT DOES NOT MATCH HOW YOU
FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT
COULD BE INCORRECT.
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Owner’s Manual
Important Health-Related Information
Severe dehydration and excessive water loss
may cause false low results. If you believe you
are suffering from severe dehydration, consult a
healthcare professional immediately.
Under normal blood concentrations and
conditions, the following should not signicantly
affect results. However, elevated
concentrations of these substances may affect
test results.
Acetaminophen ≤0.53 mmol/L Hydroxyurea ≤0.39 mmol/L
Ascorbic Acid ≤ 0.28 mmol/L L-dopa ≤0.51 mmol/L
Aspirin ≤ 3.33 mmol/L Maltose ≤26.3 mmol/L
Bilirubin ≤ 1.54 mmol/L Methyldopa ≤0.13 mmol/L
Cholesterol ≤12.9 mmol/L Tolbutamide ≤14.8 mmol/L
Creatinine ≤ 0.44 mmol/L Triglycerides ≤ 22.6 mmol/L
Dopamine ≤ 0.11 mmol/L Uric Acid ≤0.48 mmol/L
Galactose ≤ 50 mmol/L Ibuprofen ≤ 2.42 mmol/L
EDTA ≤ 12.3 mmol/L Icodextrin ≤0.01 mmol/L
Glutathione ≤1.72 mmol/L Pralidoxime
Iodide
≤0.94 mmol/L
Haemoglobin ≤0.08 mmol/L Salicylate ≤4.34 mmol/L
Heparin ≤8,000 U/dL Tolazamide ≤3.21 mmol/L
Gentisic Acid ≤0.32 mmol/L Xylose ≤6.66 mmol/L
If you are experiencing symptoms that are not
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Owner’s Manual
consistent with your blood glucose test results
and you have followed all instructions described
in this owner’s manual, contact your healthcare
professional.
Test results below 3.3 mmol/L indicate low blood
glucose (hypoglycemia). Test results greater
than 13.3 mmol/L indicate high blood glucose
(hyperglycemia). If your results are below 3.3
mmol/L or above 13.3 mmol/L, repeat the test,
and if the results are still below 3.3 mmol/L or
above 13.3 mmol/L, consult your healthcare
professional immediately.
Inaccurate results may occur in severely
hypotensive individuals or patients in shock.
Inaccurate results may occur for individuals
experiencing a hyperglycemic-hyperosmolar
state. Please refer to the test strip package insert
for additional important information.
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Owner’s Manual
Alternate Site Testing (AST)
There are important limitations to Alternate Site
Testing (AST). Please consult your healthcare
professional before performing AST.
What is AST?
Alternate Site Testing (AST)
means you can use parts
of the body other than
your ngertips to check
your blood glucose levels.
PalmDoc II meters allow you
to test on your palm, forearm,
upper arm, calf or thigh.
See Figure 1.
What is the Advantage?
Fingertips feel pain more
readily because they are full of
nerve endings (receptors). At other body sites,
nerve endings are not so numerous and you will
not feel as much pain as you will experience at
the ngertip.
Figure 1
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Owner’s Manual
When to use AST?
Food, medication, illness, stress and exercise can
affect blood glucose levels. Capillary blood at
the ngertip reects these changes faster than
capillary blood at other sites. Therefore, if you
are testing your blood glucose level during or
immediately after a meal, physical exercise or
stressful event, take the blood sample from your
ngertip only.
Use AST only:
vTwo hours or more after your last meal.
vTwo hours or more after taking insulin.
vTwo hours or more after exercise.
vDuring a relaxed and calm state.
Do not use AST if:
vYou have reason to believe you have
hypoglycemia or hyperglycemia.
vYour routine glucose results are often
uctuating.
vYou are pregnant.
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Owner’s Manual
*To increase accuracy when using AST, rub
the puncture site before extracting blood. An
alternate site device is required to perform AST.
If you do not have an alternate site device but
would like to use one, please contact your local
distributor.
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Owner’s Manual
About PalmDoc Test Strips
Key Functions of the Test Strip
PalmDoc II meters measure the amount of sugar
in the blood, commonly referred to as blood
glucose. Blood is applied to the opening of the
absorbent channel on the end of the test strip
and is automatically drawn into the test strip.
The test strip consists of the following parts:
Absorbent Channel
Apply a drop of blood and it will be
drawn in automatically.
Conrmation Window
Shows whether enough blood has been drawn
into the test strip’s absorbent channel.
Test Strip Handle
Hold this part to insert the test strip into the test
strip port on the meter.
Contact Bars
Insert this end of the test strip into the meter.
Push it in rmly until it will not go any further.
Figure 2
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Owner’s Manual
Please refer to the “Performing a Blood Glucose Test”
section for complete instructions.
Important Test Strip Information
• Store test strip packages in a cool, dry
place between 39°F–104°F (4°C–40°C).
Keep away from direct sunlight and heat. Do
not freeze. Do not store in your car.
• Store your test strips in their original vial
only. Do not transfer them to a new vial or
any other container.
• With clean, dry hands you may touch the test
strip anywhere on its surface when removing
it from the vial or inserting it into the meter.
• Do not clean the testing site with alcohol.
Instead, wash the test site thoroughly with
soap and water only.
• Immediately use a test strip after removing it
from the vial, replace the vial cap and close it
tightly to prevent exposure to moisture.
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Owner’s Manual
• Only apply a blood sample or a control
solution sample to the test strip’s absorbent
channel. Applying other substances to the
test strip’s absorbent channel will cause
inaccurate results.
• Record the discard date on the vial label
when you rst open it. Discard remaining
test strips 180 days after the rst opening
date.
• Do not use test strips beyond the expiration
date printed on the package.
• After removing the test strip from the vial,
insert it directly into the meter. Do not lay
the test strip on any other surface.
Warning: Keep the test strip vial away from
children; the vial cap and the test strips can
be a potential choking hazard. Never chew or
swallow a test strip. If this occurs, please seek
medical assistance immediately.
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Owner’s Manual
Introduction to PalmDoc II Meters
Intended Use
PalmDoc II blood glucose monitoring systems are
intended for use outside the body ( in vitro
diagnostic use only) and should only be used for
blood glucose (blood sugar) testing with fresh
capillary whole blood samples.
These systems are intended for use in the home
and in clinical settings and should not be used
for the diagnosis of diabetes or for the testing
of newborns. Consult your healthcare provider if
unusual readings occur.
Test Principle
Blood glucose is measured by an electrical
current that is produced when a blood sample
mixes with the reagent (special chemicals) of the
test strip. The electrical current changes with the
amount of glucose in the blood sample. PalmDoc
II meters measure the strength of the electrical
current, calculate your blood glucose level and
then display your result.
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Owner’s Manual
PalmDoc II meters, PalmDoc test strips and
control solutions have been designed, tested and
proven to work together as a system to produce
accurate blood glucose test results.
Important: Use only PalmDoc control solutions
and test strips with your PalmDoc II meter.
Using other test strips and control solutions
with this meter can produce inaccurate results.
Contents of the PalmDoc II Meter
The PalmDoc II meter is available as a meter
only or as a meter kit. Please check the package
contents on the outside of the box. Please review
the contents of your purchase to conrm that all
the components are included as listed on the side
of your meter box.
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