FAST. ACCURATE. EASY TO USE.
O P E R A T I O N S & Q U A L I T Y A S S U R A N C E
P R O C E D U R E M A N U A L
For
Healthcare
Professionals
TABLE OF CONTENTS
Chapter
Page
1. Microdot® Meter Overview & System Components
2. Initial Setup of the Microdot Meter
3. Control Solution Testing
4. Testing with Patients
5. Microdot Meter Specifications
6. In-Service Training Outcomes
7. Microdot Blood Glucose Meter Log Sheets
7A. Microdot BGMS In-Service Form
7B. Microdot BGMS Qualified Trainers Form
7C. Microdot BGMS Qualified Trainer/Operator
Certification Form
7D. Microdot BGMS Quality Control Record
8. Material Safety Data Sheets
8A. Microdot Test Strips
8B. Microdot Control Solutions
9. Troubleshooting the Microdot Meter
Notes
8 - 10
11 - 12
26 - 28
Contents
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5 - 7
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BLOOD GLUCOSE METER OVERVIEW
This section provides general information on the Microdot Blood
Glucose Monitoring System
The Microdot Blood Glucose Monitoring
System is a portable whole blood testing
system which performs tests with quick
and accurate results.
It consists of three main parts:
1. Microdot Blood Glucose Meter
2. Microdot Test Strips
3. Microdot High and Low Control
Solution
These products have been designed,
tested and proven to work together
as a system to produce safe and
accurate results.
Use only Microdot Test Strips
and Control Solutions with the
Microdot Glucose Meter.
Your system includes:
Microdot Meter
Anti-microbial Meter Cover
Quality Assurance Manual
Warranty Registration Card
3V Lithium Battery (installed)
Additional components include:
Microdot Test Strips
Microdot Control Solutions
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TROUBLESHOOTING THE METER
The blood glucose level is higher than
525 mg/dL.
The blood glucose level is lower than
20 mg/dL.
Error message that indicates that there
is a problem with the meter, e.g.,
measurement error (time out, overflow,
offset) or temperature out of range.
Error message that indicates that there
may be a problem with the test strip, e.g,
the test strip may be damaged, moved,
or removed during testing, or inserted
improperly.
Error message could be caused by a used
or damaged test strip.
Error message indicates serial
communications error.
The battery sign appears on the display
with the unit of measurement. The power
of the battery is getting low. You can
complete about 50 more tests from the
time this symbol first appears.
This message indicates very high
blood sugar. You should recheck the
blood glucose level. If “Hi” again,
follow facility protocol.
This message indicates very low
blood sugar. You should recheck the
blood glucose level. If “Lo” again,
follow facility protocol.
Review the instructions and try again
with a new test strip. If the problem
persists, contact Customer Service.
Check the test strip for damage and
retest as necessary. Repeat the test.
If the error message appears again,
contact Customer Service.
Repeat the test with a new strip.
If the error message appears again,
contact Customer Service.
If error persists, contact Customer
Service.
Test results will be accurate but
replace the battery as soon as
possible. Battery type is
CR2032 3 volt.
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SYSTEM COMPONENTS
Blood Glucose Meter
LCD Screen: Shows blood glucose result and
symbols that guide you through the test.
Up/Down Toggle Buttons: Scrolls the memory, sets
time and date.
Eject Button: Releases test strip.
Test Strip Port: Insertion site for test strip.
Serial Number: Located in the upper left hand corner
of the meter. Required when calling Customer
Service for troubleshooting or meter replacement.
Battery Compartment: Holds one 3V Lithium
battery (CR2032).
SN 00023463
Customer Service:
877.374.4062
Customer Service Number: Located on the back of the meter.
Call this number if you have any questions or
problems with the Microdot Glucose Meter.
(877) 374-4062
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MATERIAL SAFETY DATA SHEET
Section IX - Physical and Chemical Properties
Section X - Toxicological Information
Route of Entry
Effects of Chronic Exposure
Effects of Acute Exposure
Special Health Effects
Target Organs
Ingestion, skin and/or eye contact
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Not known
Potential Effect on Environment
Potential to Bioaccumulate
Mobility
Ecotoxicity
Persistence and Degradeability
Aqua Toxicity
Preparation Physical Form Liquid
Blue, odorless pH AS is neutral
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Not determined
Stable
Strong bases, strong acids and water reactive materials
Thermal decomposition may emit carbon monoxide and
carbon dioxide.
Section XI - Ecological Information
Pure Substance or preparation
Appearance/Odor
Odor Threshold
Melting/Freezing
Partition
Evaporation Rate
Vapor Pressure (mmHg)
Vapor Density (air =1)
Viscosity
Volatiles
Volatile Organic Compounds
Auto-flammability
Flash Point
Oxidizing Properties
Stability
Materials to Avoid
Hazardous Decomposition
Products
Section XII - Disposal Considerations
Water Disposal
Empty Container Warnings
Please consult local, state and federal regulations for
additional guidance on disposal.
Not known
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Microdot® Control Solutions
SYSTEM COMPONENTS
Test Strip
The Microdot Blood Glucose Test Strip offers the latest advances in biosensor,
auto-code technology. Blood is applied to the top edge of the Microdot Test
Strip and is automatically drawn into the white channel where the reaction takes
place. Only 600 nanoliters (0.6 microliters) is needed.
The Microdot Test Strip consists of the following parts:
Top Edge: Apply a drop of blood here, where the
white channel meets the top of the edge strip.
White Channel: This is where you check if enough
blood has been applied to the top edge.
Contact Bars: Insert this end of the test strip into the meter.
Push firmly until the strip can go no further.
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INITIAL SETUP OF THE METER
Before using the Microdot Meter for the first time, you should set the actual Time,
Date and Year. The unit of measurement is preset and can not be changed.
Setting the Time, Date and Year
Enter the Set Mode.
To Enter the set mode, turn the meter on by
pressing the C button. After the segment test,
the time and date will start to flash.
Step 1
Set the Time and Date Format.
Pressing the C button again will now toggle
between US and International Time
and Date formats.
For US: 12h Time format, mm-dd (begins with
AM setting). To accept the desired setting,
press the M button.
Step 2
Set the Hour.
The Hour will start to flash. It can now be
changed by pressing the C button. The US
setting will begin at 12:01 AM and will move
to PM. To accept the correct setting, press
the M button.
Step 3
Set the Minutes.
The Minute will start to flash, it can now be
changed by pressing the C button. To accept
the correct setting, press the M button.
Repeat Steps 1 & 2 to set Month and Year.
1.
2.
3.
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INITIAL SETUP OF THE METER
Setting the Beeper
After setting the Time and Date, the Sound
symbol will appear and can now be changed
by pressing the C button. To accept the setting,
press the M button.
This option is used to switch on or off the
beeper. When turned ON, a sound will be
heard when blood or control solution is
applied to the strip and when the test is
finished. The sound will be heard when an
error has occurred or if an alarm is
triggered.
When the M button is pressed to accept the
beeper option, the meter will display END
and switch off.
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MATERIAL SAFETY DATA SHEET
Section I - Identification
Trade Name:
Common Name:
Supplier:
Emergency Phone Number:
Microdot Control Solutions
Control Solutions for use with Microdot Xtra
Blood Glucose Test System
Cambridge Sensors USA
10051 Bode Rd.
Palinfield, IL 60585
(877) 374-4062
Section II - Composition / Information on Ingredients
Chemical Family:
Chemical Name:
Salt solution
N/A
Section III - Hazards Identification
Eye Contact:
Skin Contact:
Ingestion:
Inhalation:
Chronic Exposure
May cause irritation if in contact with eye.
Skin contact may cause irritation.
Though not a likely route of occupational exposure,
ingestion of the product may cause choking, vomiting
or nausea.
N/A
N/A
Section IV - First Aid Measures
Although no adverse health reactions are expected from
the normal use of this product, it is recommended to flush
eyes with water and seek medical advise whenever there
is a potential injury to the eye.
If contact with this product leads to reddening, inflammation
or irritation, flush the exposed area with running water. If
irritation persists, get medical attention.
As a precaution, get medical attention if there has been
ingestion of this product.
If breathing becomes difficult, remove victim to fresh air
and get medical attention.
N/A
Eye Contact:
Skin Contact:
Ingestion:
Inhalation:
Chronic Exposure:
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Microdot® Control Solutions
Using Meter Memory
Your Microdot Meter stores the 500 most recent blood glucose and control
solution test results and insulin data with date and time in the memory. It
also provides you with 14-day averages of your blood glucose test results.
You can review the test results in memory with these easy steps.
Step 1
Enter the Memory Mode.
To Enter Memory Mode, turn on the meter by
pressing the M button.
The meter will display the last result with
Mem. symbol, time and date.
Step 2
Recall Test Results.
Previous results can be displayed by pressing
the C button. As long as the C button is held, the
meter will scroll through the memory displaying
the result and the memory location. Once the
button is released, the meter will display the
selected result with its Time and Date. When the
memory is full (500 results stored), the oldest
result is dropped as the newest is added.
NOTE: When using the meter for the first time
“Mem.---” will appear, showing that there are
no test results stored in memory.
1.
2.
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INITIAL SETUP OF THE METER
®
CONTROL SOLUTION TESTING
This chapter describes the necessary steps to test with the Microdot® Control
Solutions in order to validate the performance of the MicrodotMeter and
Microdot Strips.
When Should You Conduct a
Control Solution Test?
Any time you open a new vial of test
strips.
Whenever you think the system
is not working properly.
If the blood glucose test results
differ from the resident’s symptoms
or non-symptoms.
If you believe the results are not
accurate.
If you drop the meter.
If the vial of test strips has been
left open for an extended period
of time.
It is critical to follow the Operating
Guidelines, on the right, to obtain
accurate results while using the
Microdot Glucose System.
Operating Guidelines:
Use only Microdot Control Solutions
(High and Low).
Check the expiration date on the
control solution vial. Do not use
if expired or if the discard date
has passed.
Control solution, meter and test
strips should come to room
temperature before testing
(66-77˚F / 20-25˚C).
Use solution for three months
after first opening. Record the
discard date (opening date
plus three months) on the
control solution vial. Discard
after three months.
Close tightly and store the control
solution at temperatures between
50-86˚F (10-30˚C).
Do not refrigerate. Do not freeze.
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BLOOD GLUCOSE MONITORING SYSTEM
QUALITY CONTROL RECORD
Date
Microdot Meter Serial Number
Month/Year
Station/
Initials
Test Strip
Lot #
Low
Control
Range
(mg./dl.)
High
Control
Range
(mg./dl.)
Low
Control
Result
(mg./dl.)
High
Control
Result
(mg./dl.)
Notes:
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