FOR-A MD Reference guide

BLOOD GLUCOSE MONITORING SYSTEM
Operations & Procedures Manual
Long-Term Care

3
Thank you for purchasing the FORA MD Blood Glucose Monitoring System. This
manual provides important information to help you use the system properly. Before
using this product, please read the following contents thoroughly and carefully.
If you have other questions regarding this product, please contact the place of purchase
or call Customer Service at 1-888-307-8188.
The FORA MD is intended for multi-patient use in a long-term care setting. Please note
that the following procedures are provided only as a model to help your facility establish
its own policy and procedures. Your own policy may differ depending upon the existing
procedures. Please consult with the Director of Nursing for further guidance.
CAUTION: Please carefully read the User’s Manual and all product instructions before
using this Long-Term Care and Home Health Care Manual and administering blood
glucose tests.

4
TABLE OF CONTENTS
IMPORTANT SAFETY PRECAUTIONS 06
Interfering Substances 07
BEFORE YOU BEGIN 08
INTENDED USE 08
TEST PRINCIPLE 08
METER OVERVIEW 09
Display Screen 09
Test Strip 10
Speaking Function 10
Setting the Meter 11
BEFORE TESTING 12
Checking the Code Number 12
Control Solution Testing 13
Performing a Control Solution Test 13
BLOOD GLUCOSE TESTING 14
Preparing the Puncture Site 14
Performing a Blood Glucose Test 15
CLEANING AND DISINFECTION PROCEDURES 16
Caring for Your Meter 16
METER MEMORY 18
Reviewing Test Results 18
Reviewing Blood Glucose Day Average Results 19
MAINTENANCE 19
Battery 19
Replacing the Battery 20
Meter Storage 20
Important Test Strip Information 20
Important Control Solution Information 21

5
SYSTEM TROUBLESHOOTING 20
Result Readings 20
Error Messages 21
Troubleshooting 21
SPECIFICATIONS 22
TRAINING TOOLS 23
Attachment 1: FORA MD Blood Glucose Monitoring System Training Checklist 23
Attachment 2: FORA MD Blood Glucose Monitoring System Training Quiz 24
Attachment 3: FORA MD Blood Glucose Monitoring System Quality Control Results Record 25
Notes 26

6
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
Users need to adhere to Standard Precautions when handling or using this device. All parts of the
glucose monitoring system should be considered potentially infectious and are capable of transmitting
bloodborne pathogens between patients and healthcare professionals. For more information, refer to
“Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings 2007”, http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
● The meter should be disinfected after use on each patient. This Blood Glucose Monitoring System
may only be used for testing multiple patients when Standard Precautions and the manufacturer’s
disinfection procedures are followed.
● Only auto-disabling, single-use lancing devices should be used with this device.
1. Use this device ONLY for the intended use described in this manual.
2. DO NOT use accessories which are not specied by the manufacturer.
3. DO NOT use the device if it is not working properly or if it is damaged.
4. DO NOT under any circumstances use the device on neonates or infants.
5. This device does NOT serve as a cure for any symptoms or diseases. The data measured is for
reference only.
6. Before using this device to test blood glucose, read all instructions thoroughly and practice the test.
Carry out all the quality control checks as directed.
7. Keep the device and testing equipment away from young children. Small items such as the battery
cover, batteries, test strips, lancets and vial caps are choking hazards.

7
Interfering Substances
Interfering substances depend on concentration. The interfering substances listed below will have no
effect up to the limiting concentration level noted.
* The NaF/K-oxalate concentration is the standard concentration in a blood collection tube.
Substance Limiting Concentration
(mg/dL)
Therapeutic /
Physiological Concentration Range
(or Upper Limit) (mg/dL)
Acetaminophen 6.25 0.45 - 3
Ascorbic Acid 5 2
Bilirubin (Unconjugated) 20 0 - 2
Dopamine 1.25 0.03
Levodopa 0.7 0.02 - 0.28
Methyldopa 1.875 0.1 - 0.5
Glutathione Reduced 23 47 - 100 (Intracellular)
Pralidoxime Iodide 5 ~10 ( IV Dose 500mg)
Tolazamide 12.5 1.6
Uric Acid 10 .2 - 8
Mannitol 5000 0.0128
Mannose 125 1.15
Xylose 3.125 N/A
*Na-Fluoride/K-Oxalate < 250 250
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

8
BEFORE YOU BEGIN
Severe dehydration and excessive water loss
may cause readings which are lower than actual
values. If the patient is suffering from severe
dehydration, consult a healthcare professional
immediately.
● If the patient’s blood glucose results are lower
or higher than usual, and does not have any
symptoms of illness, rst repeat the test. If the
patient has symptoms or continues to get
results which are higher or lower than usual,
follow the treatment advice of a healthcare
professional.
● Use only fresh whole blood samples to test
patient’s blood glucose. Using other substances
will lead to incorrect results.
● If the patient has symptoms that are
inconsistent with the blood glucose test results
and you have followed all the instructions given
in this owner’s manual, contact a healthcare
professional.
● We do not recommend using this product on
severely hypotensive individuals or patients in
shock. Readings which are lower than actual
values may occur for individuals experiencing
a hyperglycemic-hyperosmolar state, with or
without ketosis. Please consult a healthcare
professional before use.
INTENDED USE
This system is intended to be used for the
quantitative measurement of glucose (sugar)
in fresh whole blood samples (from the nger).
This system is intended for multiple-patient use
in professional healthcare settings as an aid to
monitor the effectiveness of diabetes control.
It should not be used for the diagnosis of
diabetes, or testing on neonates.
TEST PRINCIPLE
Your system measures the amount of sugar
(glucose) in whole blood. The glucose testing is
based on the measurement of electrical current
generated by the reaction of glucose with the
reagent of the strip. The meter measures the
current, calculates the blood glucose level, and
displays the result. The strength of the current
produced by the reaction depends on the amount
of glucose in the blood sample.
This system uses enzyme of FAD–dependent
glucose dehydrogenase (FAD-GDH) from E. coli.

9
METER OVERVIEW
Bluetooth Switch
Activates the Bluetooth function.
Test Strip Ejector
Eject the used strip by pushing up this
button.
Bluetooth Indicator
Downloads test results with a Bluetooth
connection.
Display Screen
M Button
Test Slot with Strip Indication Light
Insert test strip here to turn the meter on for
testing.
Battery Compartment
SET Button
Enter SET mode and conrm the meter
settings.
1
3
2
4
5
6
7
8
Low Battery Symbol
Test Strip Symbol
Blood Drop Symbol
Code
Volume Symbol
Test Result
Ketone Warning
Error Warning
Memory Symbol
Measurement Modes
Date
Time
Day Average
Reminder Alarms
Measurement Unit
1
3
2
4
5
9
6
10
7
11
8
12
13
14
15
Display Screen
2
6
1
3
4
58
7
3 2 145
6
7
8
9
10
11 12
13
14
15

10
Absorbent Hole
Touch a drop of blood here, blood will be
automatically drawn in.
Test Strip Handle
Hold this part to insert the test strip into the
slot.
Contact Bars
Insert this end of the test strip into the meter.
Push it in rmly until it will go no further.
Conrmation Window
This is where you conrm if enough blood
has been applied to the absorbent hole in the
strip.
1
3
2
4
Test Strip Speaking Function
FORA MD “speaks” aloud with voice instructions
to guide you through the process of blood glucose
testing. The following table tells you when and
what the meter “says”.
ATTENTION:
The front side of test strip should face
up when inserting the test strip.
Test results might be wrong if the contact
bar is not fully inserted into the test slot.
2
3
4
1
NOTE:
The FORA MD meter should only be used with FORA MD
Test Strips. Using other test strips with this meter can produce
inaccurate results.
WHEN
does the meter talk?
WHAT
does the meter say?
Using the meter
Insert test strip when
the meter is ready to
test. (symbol appears
on display)
1. Thank you for using this product.
Please relax during
measurement.
2. The Code Number is 10.
3. Please apply blood into the strip.
When the test is
completed. (result
appears on display)
Your blood glucose is (number)
(milligrams per deciliter/millimoles
per liter).
When the test result
is < 20 mg/dL.
The blood glucose is out of range
unable to measure.
When the test result
is > 600 mg/dL.
The blood glucose is out of range
unable to measure.
Recall the Stored
Test Results.
Your blood glucose is (number)
(milligrams per deciliter/millimoles
per liter).

11
Setting the Meter
Before using your meter for the rst time or if you
change the meter battery, you should check and
update these settings. Make sure you complete
the steps below and have your desired settings
saved.
Entering the Setting Mode
Start with the meter off (no test strip inserted).
Press SET to turn on the meter.
3. Setting the time
With the hour flashing, press M until the correct
hour appears. Press SET.
With the minute flashing, press Muntil the correct
minute appears. Press SET.
4. Deleting the memory
To skip deleting the memory, press SET when you
see “dEL” and a flashing “no” on the display.
Press Mto change the “no” to “yES”, and press
SET to delete all the results.
5. Setting the speaking volume
There are seven (7) speaking volume
options to choose from. Press M until the desired
speaking volume appears. To confirm your
selection, press SET. Volume 0 indicates that the
speaking function is turned off, and “ ” will not
display during testing. Volume 1 to 7 indicates
speaking volume from low to high, and “ ” will
be displayed throughout the testing.
1. Setting the date
With the year flashing, press Muntil the correct
year appears. Press SET.
With the month flashing, press Muntil the correct
month appears. Press SET.
With the day flashing, press Muntil the correct
day appears. Press SET.
2. Setting the time format
Press and release Mto select the desired time
format --- 12h or 24h. Press SET.

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7. Setting the reminder alarm
Your meter has four reminder alarms.
The meter will display “OFF” and “ ”. If you
don't want to set an alarm, press SET to skip this
step. Or press M to select "On", then press SET.
With the hour flashing, press M to select the
correct hour. Press SET.
With the minute flashing, press M to select the
correct minute. Press SET to confirm and go to
the next alarm setting.
NOTE:
• These parameters can ONLY be changed in the setting mode.
• If the meter is idle for 3 minutes during the setting mode, it will
switch off automatically.
NOTICE:
This function is referring to the Bluetooth data
transmission. If “On” is selected, your result will
be transmitted automatically right after the test.
Congratulations!
You have completed all settings!
8. Setting the Auto-Send
Press M to select the auto-send On or OFF. Press
SET.
BEFORE TESTING
Checking the Code Number
NOTICE:
The code number on the display is only for your
reference, it may not be the actual code for this
meter.
WARNING:
• It is important to make sure that the LCD displayed code is the
same as the code on the test strip vial before testing. Failure to
do so will get inaccurate results.
• If the LCD displayed code is not the same as the code on the
test strip vial, and the code number cannot be updated, please
contact Customer Service for assistance.
6. Choosing a language
Press the M button to select L1/L2. The default
language for the meter is L1, which is English. To
confirm your selection, press SET.

13
Control Solution Testing
Our Control Solution contains a known amount
of glucose that reacts with test strips and is used
to ensure your meter and test strips are working
together correctly.
Do a control solution test when:
● You rst receive the meter (optional)
● Occasionally, once a week is sufcient,
to check the meter and test strips for in-range
readings
● Every time you open a new container of test
strips
● If you drop the meter
● Whenever you get unusual results (high or low)
● Control solution is NOT used for calibration
of the meter.
Performing a Control Solution
Test
1. Insert the test strip to turn on the meter
Insert the test strip into the meter. Wait for the
meter to display the test strip and blood drop
symbols.
WARNING:
When doing the control solution test, you have to mark it so that
the test result will not mix with the blood glucose stored in the
memory.
2. Press M to mark this test as a control
solution test
With “ ” displayed, the meter will store your
test result in memory under “ ”. If you press M
again, the “ ” will disappear and this test is no
longer a control solution test.
3. Apply control solution
Ensure control solution is at room temperature
before testing. Shake the control solution vial
thoroughly before use. Squeeze out a drop and
wipe it off, then squeeze out another drop and
place it on the tip of the vial cap.
Hold the meter to move the sample area of the
test strip to touch the drop. Once the conrmation
window lls completely, the meter will begin
counting down.
To avoid contaminating the control solution, do
not directly apply control solution onto a strip.

14
Preparing the Puncture Site
We recommend you gently rub the puncture site
before puncturing the nger. This will stimulate
blood ow and avoid intestinal uid from affecting
the blood sample value.
Please follow the suggestions below before
obtaining a drop of blood:
● Wash and dry your hands before starting.
● Put on a new pair of gloves.
● Select the puncture site.
● Clean the puncture site using cotton moistened
with 70% alcohol and let it air dry.
● Rub the puncture site.
● Fingertip Testing
Press the lancing device’s tip rmly against the
lower side of patient’s ngertip.
NOTE:
• Choose a different spot each time you test. Repeated
punctures at the same spot may cause soreness and calluses.
• It is recommended that you discard the first drop of blood as it
might contain tissue fluid, which may affect the test result.
• When cleaning the puncture site, make sure alcohol is
thoroughly dry before puncture site is lanced. Testing with
alcohol remaining on skin can cause higher results.
BLOOD GLUCOSE
TESTING
If a single meter is used to test multiple patients,
the meter must be cleaned and disinfected using
the instructions as specied in this manual after
each use, whether or not blood contamination is
suspected.
Equipment Needed:
1. FORA MD Blood Glucose Meter
2. FORA MD Test Strips
3. Safety Lancet
4. Gloves
5. Alcohol Wipe or Swab
Only auto-disabling, single-use lancing
devices should be used with this device.
NOTE:
• The control solution range printed on the test strip vial is for
control solution use only. It is not a recommended range for
your blood glucose level.
• See the MAINTENANCE section for important information
about your control solutions.
4. Read and compare the result
After counting down to 0, the control solution
test result will appear on the display. Compare
this result with the range printed on the test strip
vial. It should fall within this range. If not, please
read the instructions again and repeat the control
solution test.
Out-of-range results
If you continue to have test results fall outside the
range printed on the test strip vial, the meter
and/or strips may not be working properly. Do
NOT test your blood. Contact the local customer
service or place of purchase for help.

15
Performing a Blood Glucose
Test
Consult manufacturer’s instructions for additional
information regarding the use of the FORA MD
Blood Glucose Meter.
1. Verify physician’s order.
2. Identify the patient.
3. Explain procedure.
4. Provide privacy.
5. Wash hands.
6. Put on non-sterile gloves.
7. Ensure that the meter and test strips are at
room temperature. If there is a temperature
change, the meter and test strips should sit at
room temperature for 10 to 12 minutes.
8. Verify that the vial of test strips has not expired
and/or that the vial has not been opened for
longer than 90 days. Discard the vial of test
strips if it has expired and/or has been opened
for more than 90 days.
9. Cleanse area that is to be punctured with an
alcohol swab. Allow area to dry.
10. Insert a test strip in the meter.
12. Make contact with the blood sample to the
sample area of the test strip. Blood will be wicked
into the test strip and after the conrmation
window is lled, the meter will begin counting
down.
11. Lightly hold lancet device against the skin and
lance the area. Obtain a blood sample (a hanging
drop of blood). Do not smear the blood sample as
it can affect the test result.
13. Read the result.
14. Eject the used test strip.
15. Clean and/or disinfect the meter following
the cleaning and disinfecting procedures in this
manual.
16. Remove gloves and wash hands.
NOTE:
• Do not press the punctured site against the test strip or try to
smear the blood.
• If you do not apply a blood sample to the test strip within 3
minutes, the meter will automatically turn off. You must remove
and reinsert the test strip to start a new test.
• The confirmation window should be filled with blood before
the meter begins to count down. NEVER try to add more blood
to the test strip after the blood sample has moved away.
Discard the used test strip and retest with a new one.
• If you have trouble filling the confirmation window, please
contact Customer Service at 888-307-8188.
(1.1μL blood
sample required)

16
CLEANING AND
DISINFECTION
PROCEDURES
Caring for Your Meter
To avoid the meter and test strips attracting dirt,
dust or other contaminants, please wash and dry
your hands thoroughly before use.
► Why the cleaning and disinfection should
be performed
Cleaning and disinfection are different. Cleaning
is the process of removing dirt (e.g. food debris,
grease, dust); disinfection is the process
of killing germs (e.g. bacteria and viruses).
►When to clean and disinfect the meter
Clean the meter when you see any dirt on it. You
should disinfect the meter at least once a week to
prevent infection.
► How to clean and disinfect the meter
The meter must be cleaned prior to the
disinfection. Use one disinfecting wipe to clean
exposed surfaces of the meter thoroughly and
remove any visible dirt or blood or any other body
uid with the wipe. Use a second wipe to disinfect
the meter. Do NOT use organic solvents to clean
the meter.
We recommend for meter cleaning and
disinfection you should use the disinfecting wipes/
towelettes from below. The following product has
been shown to be safe for use with the FORA MD
Blood Glucose Monitoring System.
►Micro-Kill+™ (Micro-Kill Plus™) Medline (EPA
Reg. No. 59894-10-37549)
To obtain disinfecting wipes and other information,
please contact Medline at 1-800-MEDLINE (1-
800-633-5463) or visit www.medline.com
► Disinfecting Procedures
1. Put on non-sterile gloves.
2. Take out one disinfecting wipe from the
package and squeeze out any excess liquid in
order to prevent damage to the meter.
3. Wipe all meter’s exterior surface display and
buttons. Hold the meter with the test strip slot
pointing down and wipe the area around the test
slot but be careful not to allow excess liquid to get
inside. Keep meter wet with disinfection solution
contained in the wipe for a minimum of 2 minutes
for Micro-Kill+™ wipes. Follow the instructions on
the package label of disinfecting wipe. Use two or
more wipes if necessary.
4. Remove the wipe. Allow the meter surface to
dry completely.
5. Discard the used wipes and never reuse them.
6. Remove and discard gloves in appropriate
receptacles and wash hands.

17
Each cleaning and disinfection cycle includes a
pre-cleaning step with one wipe and a disinfection
step with a second wipe.
This device has been validated to withstand
10,950 cleaning and disinfection cycles using the
recommended disinfecting wipe/towelette.
The tested number of cycles is estimated by 10
cleaning and 37 disinfection cycles per day over
3 years, the expect life of device. The meter
should be replaced after the validated number of
cleaning and disinfection cycles or the warranty
period, whichever comes rst.
Improper system cleaning and disinfection may
result in meter malfunction.
Stop using the meter if you see any signs of
deterioration. For example:
● meter cannot be turned on,
● LCD display cracks or becomes cloudy,
● buttons no longer function,
● meter outer casing cracks,
● data cannot be transmitted to PC,
● color or paint/printing on housing is abnormal,
or
● scratches or abrasions on meter are higher
than acceptable.
Please contact the customer service for a
replacement meter if any of the signs of
deterioration are noticed.
For more information regarding the risk of transmission of
bloodborne pathogens, please refer to:
● “FDA Public Health Notication: Use of Fingerstick
Devices on More than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial
Communication” (2010)
http://wayback.archive-it.org/7993/20170111013014/
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
NOTE:
• Do NOT clean and disinfect the meter while performing tests.
• If the meter is being operated by a second person, the meter
and lancing device should be decontaminated prior to use by
the second person.
• Do NOT allow cleaning and disinfecting solution to get in the
test slot, battery compartment, or strip-ejection button.
• If you do get moisture in the test strip slot, wipe it away with a
corner of tissue.
• Always dry the meter thoroughly before using it.
• Do not spray the meter directly with cleaning solutions
especially those containing water (i.e. soapy water), as this
could cause the solution to enter the case inside and damage
the electronic components or circuitry.

18
Reviewing Blood Glucose Day
Average Results
1. Press and release M
When “ ” appears on the display, keep pressing
Main button for 3 seconds until the ashing
“ ” appears. Release Main button and
then your 7-day average result measured in
general mode will appear on the display.
2. Press M to review 14-, 21-, 28-, 60- and 90-
day average results stored in each measuring
mode in the order of Gen, AC, then PC.
3. Exit the meter memory. Keep pressing Main
button and the meter will turn off after displaying
the last test result.
NOTE:
• Any time you wish to exit the memory, keep pressing Mfor 5
seconds or leave it without any action for 3 minutes. The meter
will switch off automatically.
• Control solution results are NOT included in the day average.
• If using the meter for the first time, “---” displays when you
recall the test results or review the average result. It indicates
that there is no test result in the memory.
METER MEMORY
The meter stores the 1000 most recent blood
glucose test results along with respective dates
and times in its memory. To enter the meter
memory, start with the meter switched off.
Reviewing Test Results
1. Press and release M
“ ” will appear on the display. Press M
again, and the first reading you see is the last
blood glucose result along with date, time and the
measurement mode.
(300 mg/dL)
2. Press M to recall the test results stored in the
meter each time you press. After the last test
results, press M again and the meter will be
turned off.
(200 mg/dL)
3. Exit the meter memory. After the last test
result, press Magain and the meter will be turned
off.

19
Meter Storage
● Storage conditions: -4°F to 140°F (-2°C to 6°C),
below 95% relative humidity.
● Always store or transport the meter in its
original storage case.
● Avoid dropping and heavy impact.
● Avoid direct sunlight and high humidity.
NOTE:
• Replacing the batteries does not affect the test results stored in
the memory.
• As with all small batteries, these batteries should be kept
away from small children. If swallowed, promptly seek medical
assistance.
• Batteries might leak chemicals if unused 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).
• Properly dispose of the batteries according to your local
environmental regulations.
• After replacing the batteries, the meter will enter the setting
mode.
1. Press the edge of the battery cover and lift it up
to remove.
2. Remove the old batteries and replace with two
1.5V AAA alkaline batteries.
3. Close the battery cover. If the batteries
are inserted correctly, you will hear a “beep”
afterwards.
Replacing the Battery
To replace the battery, make sure that the
meter is turned off.
1. The “ ” appears along with display
messages: The meter is functional and the result
remains accurate, but it is time to change the
batteries.
2. The “ ” appears with E-b, Error and
LOW: The power is not enough to do a test.
Please change the batteries immediately.
MAINTENANCE
Battery
Your meter comes with two 1.5V AAA size alkaline
batteries.
Low Battery Signal
The meter will display one of the messages below
to alert you when the meter power is getting low.

20
Important Control Solution
Information
● Use only FORA control solutions with your
meter.
● Do not use the control solution beyond the
expiration date or 3 months after rst opening.
Write the opening date on the control solution
vial and discard the remaining solution after 3
months.
● It is recommended that the control solution test
be done at room temperature (68°F to 77°F)
20°C to 25°C. Make sure your control solution,
meter, and test strips are at this specied
temperature range before testing.
● Store the control solution tightly closed at
temperatures between 36°F and 86°F (2°C and
30°C). DO NOT FREEZE.
Important Test Strip
Information
● Storage conditions: 35.6°F to 89.6°F (2°C to
32°C), below 85% relative humidity. Do not
freeze.
● Store your test strips in their original vial only.
● Do not transfer to another container.
● Store test strip packages in a cool dry place.
Keep away from direct sunlight and heat.
● After removing a test strip from the vial,
immediately close the vial cap tightly.
● Touch the test strip with clean and dry hands.
● Same bullet as immediately above. Delete.
● Use each test strip immediately after removing
from the vial.
● Write the opening date on the vial label when
you rst open it. Discard remaining test strips
after 3 months (90 days).
● Do not use test strips beyond the expiration
date. This may cause inaccurate results.
● Do not bend, cut, or alter a test strip in any way.
● Keep the strip vial away from children. The cap
and the test strip may be a choking hazard. If
swallowed, promptly seek medical attention.
For further information, please refer to the test
strip package insert.