FortisCare EMMU User manual

EMMU Self-Monitoring Blood Glucose System
User’s Manual
Please read this User’s Manual thoroughly
before using your blood glucose meter.

Introduction
Welcome to the FortisCare®EMMU Self-Monitoring Blood Glucose (SMBG) System. This
system is dependable & easy-to-use, utilizing a compact, lightweight and portable meter that will
aide you in monitoring your patients’ blood glucose levels.
Please read this manual thoroughly before you begin testing. It provides you and your diabetes
care team important information and step-by-step directions for use of the FortisCare®EMMU
Self-Monitoring Blood Glucose System.
Intended Use
The FortisCare®EMMU Self Monitoring Blood Glucose Test System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples drawn from the
fingertip. Testing is done outside the body (In Vitro diagnostic use). The FortisCare®EMMU
Blood Glucose System is intended for multiple-patient use in professional healthcare settings, as
an aid to monitor the effectiveness of diabetes control. The system must be used with safety
lancets, and FortisCare®EMMU Safety Lancets are a part of the system. A new safety lancet
should be used every time you perform a test. The system is not to be used on neonates, nor for
the diagnosis of, or screening for, diabetes mellitus.

Important Safety Instructions
Only single-use safety lancets (such as FortisCare®EMMU Safety Lancets) should be used, &
a new safety lancet should be used for each test.
All parts of the kit are considered biohazardous and may transmit infection, even if you have
performed cleaning and disinfection. Wash hands thoroughly with soap and water after handling
the meter. Follow Standard Precautions when using the meter and obtaining a sample. A new
pair of gloves should be worn by the user before testing each patient.
The meter should be disinfected after each use. The FortisCare®EMMU Self Monitoring Blood
Glucose Test System may be used for testing multiple patients when Standard Precautions and
the disinfection procedures included in this manual are followed.
Included with each FortisCare®EMMU Blood Glucose Meter:
Available separately:
• FortisCare
®
Control Solution (Normal)
• 2 AAA batteries
• User’s Manual
• FortisCare
®
Blood Glucose Test Strips
• FortisCare®Safety Lancet
• FortisCare
®
Control Solution (Low)
& (High)

For further information, please see:
"Biosafety in Microbiological and Biomedical Laboatories (BMBL)"
http://www.cdc.gov/biosafety/publications/bmbl5/
"Protection of Laboratory Workers From Occupationally Acquired Infections; Approved
Guideline--Third Edition " Clinical and Laboratory Standards Institute (CLSI) M29-A3.
“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings 2007”, http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
“FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses
Risk for Transmitting Bloodborne 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 Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

Important Information about your new FortisCare®EMMU Meter
The FortisCare®EMMU Blood Glucose Meter is designed and approved for testing fresh
capillary whole blood samples from the fingertip, palm and forearm. The meter is for in vitro
use ONLY (for testing outside the body). It should not be used to diagnose diabetes.
Remove batteries if the meter will not be used for one month or more.
The FortisCare®EMMU Blood Glucose Meter can only be used with FortisCare®Blood
Glucose Test Strips. Other test strips will give inaccurate results. FortisCare®Blood
Glucose Test Strips feature a unique glucose dehydrogenase chemistry system.
Testing is not valid for neonatal blood specimens.
Do not disassemble the meter as this may cause damage to the components resulting in
incorrect readings. Disassembling the meter will also void the warranty.
Always keep the meter clean and store it in a safe place. Protect the meter from direct
sunlight to ensure a longer lifespan.
You should not store the meter and test strips in a car, a bathroom or a refrigerator.
Keep the meter, test strips and safety lancets away from children and pets.
You should not test critically ill patients with home-use blood glucose meters.
Critically ill patients should not be tested with blood glucose meters. See page 9 for more
explanation.
Warning for potential biohazard: Healthcare professionals using this system on multiple
patients should be aware that all products or objects that come in contact with human blood,
even after cleaning, should be handled as if capable of transmitting viral disease.

Note:
Do not touch the strips with wet hands.
Do not use expired strips (the expiration date is shown on the vial.)
Do not bend, cut or twist the strips.
Altitude up to 10,000 feet above sea level has no effect on readings.
Why is it so important to test blood glucose regularly?
Testing blood glucose regularly can make a big difference in how you manage your patients’ day
to day diabetic care. We’ve made the FortisCare®EMMU Self-Monitoring Blood Glucose System
as simple as possible to help you use it regularly.
Do you need Help?
If you have questions or need assistance, please call the Customer Care Service toll-free at
866-922-6033 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM).

Health-Related Information
If the patient is experiencing dehydration, frequent urination, low blood pressure, shock or
hyperosmolar hyperglycemic nonketotic coma (HHNKC), you may get a test result that is
lower than the actual blood glucose level. We recommend confirming the result on such
patients via a clinical laboratory.
If you have followed the steps in the user’s manual, but still have symptoms that don’t seem
to match your test results, or if you have questions, please call the Customer Care Service
toll-free at 866-922-6033 (Eastern Standard Time, Mon-Fri 8:00AM~6:00PM).
Healthcare personnel should wash hands & change gloves between patients, even if
patient-dedicated testing devices and single-use lancing devices are used.
Note: Warning for potential biohazard:
Healthcare professionals using this system on multiple patients should handle all
products or objects in contact with human blood carefully to avoid transmitting viral
disease, even after cleaning.

Explanation of Meter Symbols
Date
(on the left side)
Medical Record No.
(patient number)
Time
(on the right side)
Apply Control
Solution
AM
(Before Noon)
Apply blood
PM
(After Noon ) Unit
Result / Message Battery
Insert a strip Temperature

Table of Contents
Chapter 1: Understanding Your Meter ….................................................................................11
The FortisCare®EMMU Blood Glucose Meter …................................................................11
The FortisCare®EMMU Accessories...................................................................................12
Inserting Batteries.................................................................................................................13
Setting the Time, Date and Medical record...........................................................................14
Using FortisCare®Blood Glucose Test Strips ……………………........................................16
Chapter 2: Control Solution Test .............................................................................................17
When to Run a Control Solution Test ...................................................................................17
About Control Solutions .......................................................................................................18
Running a Control Solution Test ..........................................................................................19
Understanding Control Solution Test Results …...................................................................21
Chapter 3: Testing Your Blood Glucose .................................................................................23
Instructions for Using the FortisCare®Lancets....................................................................23
Running a Blood Glucose Test with Blood from Your Fingertip ............................................24
Understanding Your Test Results ….....................................................................................27
Unusual Test Results ….......................................................................................................27

Chapter 4: Meter Memory, Setup …..........................................................................................28
Memory, Storing Test Result …............................................................................................28
Viewing and Deleting Test Results…....................................................................................29
Running With Your Computer…............................................................................................30
Chapter 5: Maintenance and Troubleshooting …....................................................................31
Inserting Battery …...............................................................................................................31
Cleaning and Disinfecting the FortisCare®Blood Glucose Meter........................................32
Cleaning And Disinfection Frequency...................................................................................36
Maintenance and Testing .....................................................................................................37
Screen Messages and Troubleshooting …...........................................................................38
Chapter 6: Technical Information ….........................................................................................42
Specifications …...................................................................................................................42
Limitation …..........................................................................................................................43
Device Information …...........................................................................................................46
Warranty.............................................................................................................................46

11
Chapter 1: Understanding Your Meter
FortisCare®EMMU Blood Glucose Meter
Display-
Shows results,
patient numbers,
and messages.
Left ()Button-
Press to enter memory,
adjust setting, and
scroll through results.
Test Strip Slot-
Insert a test strip here.
Battery Door-
Flip open the
battery door by
pushing the tab in
the direction of the
arrow and pulling
the door up.
Right () Button-
Press to enter
memories, adjust
setting, and scroll
through results.
Power Button-
Press to turn on/off
the meter, and to
confirm the setting.
Strip Ejector-
Push the Strip
Ejector to remove
the strip.

12
The FortisCare®EMMU Accessories
Blood Glucose Test Strip Test Strip Bottle
Control Solution Bottle
Expiration Date
Safety Lancet
Lancet
Protector
Lancet Holder
Note: The used lancet
cannot be reloaded.
Strip Insert
Direction
Reaction area
Hand Hold
Area
Blood collection
area
Electrode

13
Inserting Batteries
1. Open the battery door on the back of the meter by pushing the tab in the direction of the
arrow and pulling the door up.
2. Insert two batteries. The meter will beep to confirm the batteries are inserted correctly.
3. Put the battery door back in place and snap it closed.

14
Setting the Time, Date and Medical record — First Time Use
Setting the current time and date in your meter is important if you use the meter memory.
2. Press (Right button)
for 2 seconds to get into
the setting mode.
3. The large display shows the last
2-digit of the year that flashes at
the top of the display as well.
Press (Left button) or (Right
button) to adjust the year and
press (Power Button) to
confirm the setting.
1. Press (Power Button)
to turn the meter on.

15
4. Repeat step 2 to set the date
and time. The flashing field is
the one you are currently
setting.
5. Press (Left button) or (Right button) to turn on/off
the function of medical record number and press
(Power Button) to confirm the setting.
Note: When the function of turns on, it allows you to identify different testing
objectives by marking them from 001-999 so the testing results can be reviewed
by the medical record numbers you mark them.

16
Using FortisCare®Blood Glucose Test Strips
Use only with FortisCare®Blood Glucose Meters.
FortisCare®EMMU Self-Monitoring Blood Glucose System is a “no code” system and does
not require test strip calibration.
FortisCare®EMMU Self-Monitoring Blood Glucose System utilizes glucose dehydrogenase
chemistry to avoid incorrect readings on patients receiving Oxygen therapy.
Run a control solution test every time you open a new box of strips (See Chapter 2 “Control
Solution Testing.”)
After you take a test strip out of the vial, tightly close the vial immediately to keep the test
strips dry.
Use the test strip within three minutes after taking it out of the vial.
The strip is for single use only. Do not reuse it.
When you open a new test strip vial, check the expiration date. The test strips are good for
the six months from the initial date the vial is opened or until the expiration date, whichever
comes first. Record the date you initially open the test strip vial in the designated spot on
the vial.
Store the test strip vial and your meter in a cool dry place, between 35.6°F - 86°F (2°C-
30°C). Do not freeze.
Insert the test strip into the meter before applying blood or control solution.
Do not touch the test strip with wet hands. Do not bend, cut, or twist the test strips.

17
Chapter 2: Control Solution Testing
When to Run a Control Solution Test
Running the FortisCare®Control Solution Test will let you know that your meter and test strips
are working properly. You should run control solution tests:
If you are using a new FortisCare®EMMU Blood Glucose Meter.
When you open a new vial of FortisCare®test strips.
If you think the meter or test strips may be working incorrectly.
If the meter is dropped.
If the results are lower or higher than expected, you have repeated the test with similar
results.
When you practice the test procedure.

18
About Control Solution
Use only with FortisCare®test strips.
Write the date you initially opened the Control Solution bottle on the label. The control
solution is good for three months from the date the bottle is opened or until the expiration
date on the bottle, whichever comes first.
Do not use a control solution that is past the expiration date.
The control solution can stain clothing. If you spill it, wash your clothes with soap and water.
Close the bottle tightly after every use.
Left over control solution should not be returned to the control solution bottle.
Store the bottle of control solution at room temperature, between 35.6°F - 86°F (2°C- 30°C).
Do not freeze.
FortisCare®Control Solutions are available in Level 1 (Low), Level 2 (Normal), and Level 3
(High). To purchase, contact your medical supply distributor or Oak Tree Health.

19
Running A Control Solution Test
You need the meter, a test strip, and control solution.
1. Put a test strip into the
meter in the direction of
the arrow.
3. Place the meter on a
flat surface, like a table.
4. Remove the control
solution bottle cap and
wipe the tip of the bottle
with a tissue.
5. Squeeze the bottle until
a tiny drop forms at the
tip of the bottle and
place solution on top of
bottle cap.
2. Press (Left button) to select the
mode of Control Solution, and the
icon of flashes.

20
6. Touch the drop to the Blood
collection area at the tip of
the test strip. Do not put
control solution on the top
of test strip The meter
starts to count down from 5
seconds and will show the
results.
7. Do not remove the test strip
until you confirm that the
reading falls within the range
printed on the test strip vial.
8. Push the Strip Ejector to
eject the test strip.
9. Dispose properly.