FOR-A MD User manual

Blood Glucose Monitoring System
Owner’s Manual
Operator’s Manual

Dear FORA MD Control System
Owner:
Thank you for choosing FORA MD Control Blood Glucose
Monitoring System. Please use with FORA MD Control Blood
Glucose Test Strips only.
This easy-to-use monitoring system provides fast and accurate
results, including automatic upload of test results to hospital and
laboratory information systems enabling powerful data management.
This monitoring system also reduces risks of operator errors and
allows one hand operation by hospital professionals through simple
steps. Integrated barcode scanning helps reduce the risk of manual
data entry errors as well. There is no subjective calibration procedure
required.
This manual contains important information about the system.
Please read it thoroughly and carefully, and keep it for future
reference. If you have further questions about this system, please
contact the Customer Service Center toll-free at 1-888-307-8188
(7:00 am - 6:00 pm PST, Mon. - Fri.) or visit www.foracare.com.
Version 1.0 2016/01
311-4258400-001

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 blood-borne 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.ht
ml.
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.
The following basic safety precautions should always be taken.
1. Only the healthcare providers who have trained for this system
should operate.
2. Use the device only for the intended use described in this
manual.
3. Make sure to properly setup the system and pass the training test
before performing any tests.

4. Keep the equipment and its flexible cord away from hot surfaces.
5. Do not use the device if it is not working properly or damaged.
6. Before using this product to test blood glucose, read all
instructions thoroughly and practice the test. Do all quality control
checks as directed.
7. Always wear gloves when performing tests and follow your
facility’s infection control policy and procedures.
8. Please do not use accessories which are not specified by the
manufacturer.
9. The meter should be disinfected after use on each patient.
Please refer to section Taking Care of the Meter & Strips for
cleaning and disinfection procedures.
10. Only auto-disabling, single use lancing devices may be used with
this device.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN ............................................................................ 1
Important Information.................................................................... 1
Intended Use ................................................................................ 1
CONTENTS OF SYSTEM ....................................................................... 3
Meter Overview............................................................................. 4
Test Strip....................................................................................... 5
Meter Functions ............................................................................ 6
BEFORE USE ......................................................................................... 7
Battery Setup & Recharge............................................................ 7
Setup Mode .................................................................................. 8
Barcode Scanning Procedure....................................................... 9
Calibration..................................................................................... 9
TRAINING ............................................................................................. 10
CONTROL TEST....................................................................................11
Guidelines for Control Solution Testing........................................11
Control Test Procedure ............................................................... 12
PATIENT TEST ..................................................................................... 15
Collecting Blood Samples........................................................... 16
Patient Test Procedure ............................................................... 18
Results Indicators ....................................................................... 21
MEMORY MODE................................................................................... 22
Reviewing Test Results............................................................... 22
Reviewing Test Results by “All Records”.................................... 23

Reviewing Test Results by “Patient Record”............................... 25
Reviewing Test Results by “Operator Record”............................ 26
Reviewing QC Data .................................................................... 27
Reviewing Proficiency Data ........................................................ 28
TAKING CARE OF THE METER & STRIPS ........................................ 29
Disinfecting Procedures.............................................................. 30
Storage ....................................................................................... 32
ERROR MESSAGES ............................................................................ 34
DETAILED INFORMATION................................................................... 36
Reference Values ....................................................................... 36
Comparing Meter and Laboratory Results.................................. 36
SPECIFICATIONS................................................................................. 38

1
BEFORE YOU BEGIN
Important Information
Severe dehydration and excessive water loss may cause
readings which are lower than actual values.
Use only fresh blood samples to test patient’s blood glucose.
Using other substances will lead to inaccurate results.
We do not recommend using this product on severely
hypotensive individuals or patients who are in shock. Readings
which are lower than actual values may occur for individuals in a
hyperglycemic-hyperosmolar state, with or without ketosis.
Before you start, there are a few important things to remember.
Before performing patient tests, please read this Operator’s Manual
carefully.
The FORA MD Control Blood Glucose Monitoring System must be
properly set up (configured) before performing patient or quality
control tests. Configurations can be set up on the meter or through
MD Control Management System according to each facility’s
requirements.
You should always wear gloves and follow your facility’s infection
control procedures when handling blood-contaminated items. If you
need help when using the meter or during the testing, please read
this manual carefully. If you still have a question, please contact local
customer service for assistance.
Intended Use
This system is intended for use in the quantitative determination of

2
glucose levels in fresh capillary whole blood from the finger and
venous whole blood samples. It is indicated for multiple patients use
by health care professionals in health care facilities as an aid in
monitoring the effectiveness of a diabetes control program.
This system is only used with single-use lancing devices. It is not
intended for the diagnosis of or screening for diabetes mellitus.
Test Principle
This 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. Your 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.

3
CONTENTS OF SYSTEM
Your FORA MD Control Blood Glucose Monitoring System kit
includes:
1. Meter
2. Operator's manual
3. Warranty Card
4. Rechargeable Li-Battery
5. USB Cable
Test strip and control solution may be purchased separately. Please
make sure you have those items needed for a blood glucose test
beforehand.
NOTE:
If any items are missing from your kit or opened prior to use, or to obtain test 
strips and control solutions, please contact the place of purchase or call
Customer Service for assistance.

4
Meter Overview
USB port (for mini
USB cable)
Strip Ejection Button Recharge Indicator
LCM Panel Reset Button Battery Compartment
Up Button On/Off Button Scan Button
Down Button Number Button Return Button
Barcode Scanner
1
2
3
4
5
6
7
8
1
10
11
9
12
13

5
Test Strip
ATTENTION:
The front side of test strip should face up when
inserting test strip.
Test results might be wrong if the contact bar is not
fully inserted into the test slot.
NOTE:
The FORA MD Control blood glucose monitoring system should only be 
used with FORA MD Control blood glucose Test Strips. Using other test
strips with this meter may produce inaccurate results.
1. Absorbent Hole
Apply a drop of blood here. The blood will be
automatically absorbed.
2.Confirmation Window
This is where you confirm if enough blood has been
applied to the absorbent hole of the strip.
3.Test Strip Handle
Hold this part to insert the test strip into the slot.
4.Contact Bars
Insert this end of the test strip into the meter.
Push it in firmly until it will go no further.

6
Meter Functions
When the meter is turned on by pressing On/Off button, five modes
are available on the main menu: Measure Mode, QC Mode, Memory
Mode, Urgent Mode and Setup Mode. User can select each mode
simply by pressing Up or Down button and enter the desired mode by
pressing S button.
MainMenu
QCModeMemoryMode MeasureMode SetupModeUrgentMode
TestResults Proficiency
Data QCData
AllRecord PatientRecord Operator
Record
SettingDate SettingUnit BacklightCtrl
Training Meter
Information SetBarcode

7
BEFORE USE
Battery Setup & Recharge
This meter uses one Li-ion rechargeable battery. Please follow the
instructions below to setup the meter.
1. Press and push the battery cover on the back of the meter
outward and then remove the cover.
2. Read the instructions on the battery first. Then put in the battery
and push it to the right side of the compartment and insert the
battery appropriately.
3. To take out the battery, please press the clicker on the left side of
the compartment. The battery will be automatically ejected and
can be easily removed.
When the battery is low, a battery symbol will display on the screen,
which means it is about time to recharge the battery.
To recharge the battery, please connect the USB cable to the USB
port of the meter and to the computer. The recharge indicator will
light up in red when the battery is recharging. When the battery is
fully recharged, the indicator will turn green.
If using AC/DC power adapter to recharge the meter, please connect
the USB cable to an electrical outlet and the meter. After the battery
is fully recharged, the recharge indicator will be green.
NOTE:
One fully charged battery is expected to last for approximately 500 
measurements.

8
Setup Mode
Please follow the step-by-step instructions below to setup your
FORA MD Control Blood Glucose Monitoring System.
1. Setting the year, month, and day
Press On/Off button to turn on the meter.
After pressing Up/Down button to select
“Setup Mode”, press S button, and the
screen will display “Setting Date”. Press
S button to go to the next step.
Press Up/Down button to select the
desired date format. Press S button to
go to the next step.
Press Up/Down button to select the
desired year, month and day. Press S
button to go to the next step.
2. Setting the hour
Press Up/Down button to select 12H or
24H (time format). Press S button to go
to the next step.
Press Up/Down button to select the
desired “hour” and “minute”. Press S
button to go to the next step.

9
3. Setting the unit of blood glucose
The screen returns to “Setup Mode”
menu. Press Up/Down button to select
“Setting Unit” and then press Up/Down
button to select “mmol/L” or “mg/dL”.
Press S button to go to the next step.
4. Setting the backlight
The screen returns to “Setup Mode”
menu. Press Up/Down button to select
“Backlight Ctrl”. Press Up/Down button
to adjust the backlight and then press S
button to complete this setup.
Barcode Scanning Procedure
Press and hold the S button with the bottom of the meter facing the
barcode until hearing a short beep. The operator’s ID, patient’s ID,
and the strip lot number will automatically be saved in the meter.
Calibration
When using the system for the first time, or before using a new vial of test
strips, you will need to calibrate the meter. After scanning the valid
operator ID and patient ID, make sure to scan the barcode on the
test strip vial (the Test Strip ID). Simply press S button and scan the
barcode, the meter will automatically calibrate with the test strip. It is
necessary to take this action before you proceed to the testing.
Failure to do so may lead to inaccurate test results.

10
TRAINING
Each operator has to pass a training test through Training Mode
before performing measurements for patients (Measure Mode). This
FORA MD Control monitoring system will evaluate the examinee’s
training by simple testing and only successful trainees will become
proficient operator to access Measure Mode.
Training Test Procedure
Please follow the steps below to access Training Mode.
1. Press the On/Off button to turn on the
meter, and select setup mode.
2. Press Up/Down button to select
Training Mode, and then press S
button.
3. Scan or manually enter the examinee’s
ID via the keypad.
4. Perform a Control Test.
Please refer to the Control Test Procedure section to perform
control tests.
5. Perform a Patient Test.
Please refer to the Patient Test Procedure section to perform
patient tests.

11
6. The training data can be uploaded to
the MD Control Management System by
connecting FORA MD Control to a PC
via a USB cable.
NOTE:
If the examinee passes the evaluation, he/she will become a “Proficient 
Operator” and only a “Proficient Operator” can access the Measure Mode.
CONTROL TEST
This section explains how to take a control solution test in order to
verify the performance of FORA MD Control Blood Glucose
Monitoring System.
The quality control procedure of the meter can be customized to fit
the requirements of each facility. For example:
Tests of Level 1, Level 2, and Level 3 control solutions or other
variation of quality control testing depend on the facility’s policy.
Control solution tests are performed regularly, in specific time
intervals, or with the number of patient test results.
Control test results can appear as numeric or Pass/Fail.
Guidelines for Control Solution Testing
Please follow the guidelines below to obtain optimal quality control
results when using FORA MD Control Blood Glucose Monitoring
System.
Only use the control solutions for FORA MD Control blood glucose
test strips.
When using a new bottle of control solution, write the opening date
on the bottle label. Each bottle of control solution is stable for use