FOR-A D40 Pro User manual

Blood Glucose Plus Blood Pressure Monitoring System
Sistema de Vigilancia de Glucosa Sanguínea y
Medidor de Presión Arterial
Owner’s Manual
Manual del Propietario

Dear FORA D40 Pro System Owner:
Thank you for purchasing the FORA D40 Pro Blood Glucose Plus Blood
Pressure Monitoring System. This manual provides important
information to help you to use the system properly. Before using this
product, please read and follow the instructions in this Owner's Manual.
This system is intended to be used by healthcare professionals for
multiple patients in a professional healthcare setting (i.e. hospitals,
doctor’s office, etc.) According to the clinical studies from American
Diabetes Association, elevated blood pressure often accompanies adult
diabetes patients. These studies also suggest that diabetes patients
could reduce the risk of cardiovascular diseases by managing their
blood glucose levels and blood pressure.
Therefore, with easy operation of this FORA D40 Pro Blood Glucose
Plus Blood Pressure Monitoring System, you can easily monitor your
patients’ blood glucose levels and blood pressure at any place, any time.
In addition, this system can help you and the healthcare professionals
to monitor and adjust the patients’ treatment plans, and keep their
diabetes and blood pressure under control.
If you have questions, just call ForaCare Customer Care Service Center
toll-free at 1-888-307-8188 (8:30 am - 5:00 pm PST, Mon. - Fri.). You
can also visit www.foracare.com.
Version 1.0 2016/12
311-3261500-006
English

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
Users should 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.html
The system 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 may 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 specified by the
manufacturer.
3. Do NOT use the device if it is not working properly or if it is
damaged.
4. Do NOT use the equipment where aerosol sprays are being used or
where oxygen is being administered.
5. Do NOT under any circumstances use the device on newborns or
infants.
6. This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only.
7. 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.

8. 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.
9. Keep the device and its flexible cord away from hot surfaces.
10. Do NOT apply the cuff to areas other than the place directed.
11. Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.
12. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
13. Proper maintenance and periodically control solution test are
essential to the longevity of your device. If you are concerned about
your accuracy of measurement, please contact the local customer
service or place of purchase for help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN 1
Important Information 1
Intended Use 2
Test Principle 2
Contents of System 3
Meter Overview 4
Meter Display 6
Test Strip 7
Setting the Meter 8
THE FOUR MEASURING MODES 10
Control Solution Testing 11
Performing a Control Solution Test 12
TESTING WITH BLOOD SAMPLE 14
Preparing the Puncture Site 15
Alternative Site Testing 16
Performing a Blood Glucose Test 18
TESTING THE BLOOD PRESSURE 20
Before Measurement 20
Fitting the Cuff Correctly 20
Proper Measurement Position 21
Taking Measurements 22
METER MEMORY 25
Reviewing Test Results 25
Reviewing Day Average Results 26
DATA TRANSMISSION VIA BLUETOOTH 27
MAINTENANCE 29
Battery 29
Caring for Your Meter 32
Disinfecting Procedures 33
Caring for Your Test Strips 36

Important Control Solution Information 37
SYSTEM TROUBLESHOOTING 38
Result Readings 38
Erroor Messages 39
Troubleshooting 40
DETAILED INFORMATION 42
Reference Values 42
SPECIFICATIONS 44
FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT 46

1
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 patients’ blood glucose results are lower or higher than usual,
and do not have symptoms of illness, repeat the test. If the patient
has symptoms or continue to get results which are higher or lower
than usual, follow the treatment advice of the healthcare
professional.
Use only fresh whole blood samples to test the patient’s blood
glucose. Using other substances will lead to inaccurate 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 the healthcare professional.
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. Please
consult the healthcare professional before use.
Critically ill patients should not be tested with a blood glucose
monitoring system.
Important Information

2
The FORA D40 Pro Blood Glucose Plus Blood Pressure Monitoring
System is intended for use in the quantitative measurement of glucose
in fresh capillary whole blood from the finger and the following
alternative sites: palm, forearm or upper-arm. This system is intended
for multiple-patient use in professional healthcare settings as an aid to
monitor the effectiveness of diabetes control. This system is only used
with single-use auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for
diabetes, nor for neonatal use. Alternative site testing such as the palm,
forearm, and upper arm should be done only during steady – state
times (when glucose is not changing rapidly).
This system is also intended to be used to measure non-invasively the
systolic and diastolic blood pressure and pulse rate of an adult
individual. The blood pressure is measured by using an inflatable cuff
wrapped around the arm.
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.
The blood pressure is measured non-invasively at the arm based on the
Oscillometric method.
This device is NOT able to take measurements in the presence of
common arrhythmia, such as atrial or ventricular premature beats or
atrial fibrillation. It may produce reading errors.
Intended Use
Test Principle

3
The FORA D40 Pro system kit includes:
○
1Meter ○ 5Daily Log Book
○
2Owner’s Manual ○ 6Li-Ion Rechargeable Battery
○
3Protective Wallet ○ 7Pressure Cuff
○
4Warranty Card ○ 8AC Adapter
Test strips, control solution and safety lancets 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.
Contents of System

4
Meter Overview

5
○
1Display Screen
○
2RF Button
Assists you with wireless data
transmission.
○
3S Button
Enter and confirm the meter
settings.
○
4M Button
Enter the meter memory.
○
5AVERAGE Button
Assist you with blood pressure
average mode.
○
6ON/OFF Button
To start a single non-invasive
blood pressure measurement.
○
7Power Indicator
Indicates the power status of
the device.
○
8RF Indicator
Indicates a wireless data
transmission.
○
9Test Slot
Insert test strip here to turn the
meter on for testing.
○
10 Battery Compartment
○
11 Strip Ejector
Eject the used strip by pushing
up this button.
○
12 AC/DC Adapter Port
Connect to a power supply.
○
13 Pressure Cuff
○
14 Air Tube
○
15 Air Plug
Connect to air jack.
○
16 Air Jack

6
○
1Date ○
10 Pulse Rate
○
2Systolic Pressure Symbol ○
11 Day Average Result
○
3Measuring Mode ○
12 Battery Symbol
○
4Systolic Pressure Value ○
13 Memory Mode Symbol
○
5Diastolic Pressure Symbol ○
14 Unit for Blood Pressure
○
6Diastolic Pressure Value ○
15 Unit for Blood Glucose
○
7Volume Symbol ○
16 Time
○
8Ketone Warning ○
17 Test Strip Symbol
○
9Heart Symbol- for IHB
Detection (Irregular Heart
Beat)
○
18 Blood Drop Symbol
Meter Display

7
Absorbent Hole
Apply a drop of blood
here. The blood will be
automatically absorbed.
Confirmation Window
This is where you confirm
if enough blood has been
applied to the absorbent
hole in the strip.
Test Strip Handle
Hold this part to insert
the test strip into the
meter slot.
Contact Bars
Insert this end of the test
strip into the meter. Push
it in firmly until it stops.
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 D40 Pro Blood Glucose Plus Blood Pressure Monitoring System
should only be used with FORA D40 Pro Test Strips. Using other test strips
with this monitoring system can produce inaccurate results.
Test Strip

8
Before using your meter for the first 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 S.
1. Setting the date
With the year flashing, press Mbutton
until the correct year appears. Press S.
With the month flashing, press Mbutton
until the correct month appears. Press
S.
With the day flashing, press Mbutton
until the correct day appears. Press S.
2. Setting the time
With the hour flashing, press Mbutton
until the correct hour appears. Press S.
With the minute flashing, press M
button until the correct minute appears.
Press S.
Setting the Meter

9
3. Setting the time format
Press Mbutton to select the desired
time format --- 12h (AM/PM) or 24h.
Press S.
4. Setting the auto-send
Press Mbutton to select the auto-send
On or OFF. Press S. This function is for
the Bluetooth transmission. If On is
selected, your result will be transmitted
right after each test.
5. Deleting the memory
With “dEL” and flashing “ ” on the
display, if you do not wish to delete the
saved results, press Sto skip this step.
If you wish to delete ALL the results,
press Mbutton twice.
6. Setting the cycle mode
Press Mbutton to choose the desired
blood pressure cycle mode from the
following time interval selections: OFF, 5,
10, 15, 20, 30, 40 or 60 minutes. Press
to Sto turn off the meter.
Congratulations! You have completed all settings!
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.

10
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring: General, AC, PC
and QC.
MODES USE WHEN
General tests
(GEN)
any time of day without regard to time since last
meal
AC no food intake for at least 8 hours
PC 2 hours after a meal
QC testing with the control solution
You can switch between each mode by:
1. Start with the meter switched off.
Insert a test strip to turn on the meter.
2. Press Mbutton to switch between
General, AC, PC and QC mode.

11
FORA control solutions contain a known amount of glucose that reacts
with test strips and is used to ensure your meter and test strips are
working together correctly.
Test strips or control solutions may not be included in the kit (please
check the contents on your product box). They can be purchased
separately. Please make sure you have those items needed for a
control solution test beforehand
Do a control solution test when:
you first receive the meter,
at least once a week to routinely check the meter and test strips,
you begin using a new vial of test strips,
you suspect the meter or test strips are not working properly,
your patients’ blood glucose test results are not consistent with how
they feel, or if you think the results are not accurate,
practicing the testing process, or
you dropped or think you have damaged the meter.
Control Solution Testing

12
1. Insert the test strip to turn on the
meter
Insert a test strip into the meter. Wait
for the meter to display “ ” and “ ”.
2. Press M button to mark this test as
a control solution test
WARNING:
When doing the control solution test, you have to mark it so that the test
result will NOT mix with the blood glucose TEST RESULTS stored in the
memory. Failure to do so will mix up the blood glucose test results with the
control solution test results in memory.
3. Apply control solution
Shake the control solution vial thoroughly before use. Squeeze out a
drop and wipe it off, and then squeeze out another drop and place it on
the tip of the vial cap. Hold the meter in an angled position so that the
absorbent hole of the test strip touches the drop. Once the confirmation
window fills completely, the meter will begin counting down. To avoid
contaminating the control solution, do not directly apply control solution
onto the strip.
Performing a Control Solution Test