FOR-A D10 User manual

FORA D10
BLOOD GLUCOSE
PLUS BLOOD PRESSURE
MONITORING SYSTEM
English
311-3224100-006
Version 4.0 2012/12

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Thank you for choosing
D10
BLOOD GLUCOSE PLUS
BLOOD PRESSURE
MONITORING SYSTEM
This product can assist you in monitoring your blood glucose level as well
as your blood pressure. You can visit our website www.foracare.com/usa
to view other updated instructions or product information.
This owner’s manual contains important information that you must
know about your system. Please read it carefully and keep it for
future reference.
For other questions regarding this system, please contact your local
customer service. For all other questions, contact your health care
professional for assistance.

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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.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 may be used
with this device.
For more information on the risk of blood-borne pathogen transmission from
blood glucose meter and lancing devices, please refer to:
1. “FDA Public Health Notication: 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
2. “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

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1. Use this device ONLY for the intended use described.
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 use the equipment in places where aerosol sprays are
being used, or where oxygen is being administered.
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.
8. Use of this device in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may
cause damaging static discharges that may cause erroneous
results.
9. Do not use this device in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the
accurate operation.
10.Read all instructions thoroughly and practice the test before
using the product to test your blood glucose. Do all quality
control checks as directed and consult with a diabetes
healthcare professional.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

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TABLE OF CONTENTS
BEFORE YOU START 07
Warnings and Precautions 07
Detailed Information 08
ABOUT THIS SYSTEM 10
Intended Use 10
Principle of Measurement 11
Alternative Site Testing 12
Content of the System 14
Appearance and Key Function of the Monitor 15
LCD Screen 16
Test Strip 17
BEFORE USE 18
Battery Installation and Replacement 18
Setting the Monitor 20
BLOOD GLUCOSE MEASUREMENT 23
Important Information 23
Checking with FORA Control Solution 24
Important Control Solution Information 25
Performing a Control Solution Test 26
Testing Your Blood Glucose 29
Reading Your Result 35
Comparing Monitor and Laboratory Results 36

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BLOOD PRESSURE MEASUREMENT 38
Suggestions Before Measuring 38
Correct Application of the Pressure Cuff 39
Testing Your Blood Pressure 40
MONITOR MEMORY 42
Viewing Results on the Monitor 42
Viewing the Average Blood Glucose Results 43
Viewing Results on a Personal Computer 44
TAKING CARE OF YOUR MONITOR & STRIPS 45
Caring for Your Meter 45
Storage 50
TROUBLESHOOTING 52
Error Message 52
Problem in Operation 54
SPECIFICATIONS 59

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BEFORE YOU START
Warnings and Precautions
The FORA D10 system is designed for use on individuals age
16 and above. It shall NOT be used under any circumstances
on newborns, infants or persons who cannot communicate.
This device does NOT serve as a cure for any symptoms or
diseases. The data measured are for reference only. Always
consult your physician to have the results interpreted.
This device is NOT able to take measurements in the presence
of common arrhythmia, such as arterial or ventricular premature
beats or arterial brillation. It may produce reading error.
Do NOT use the device for purposes other than measuring
blood glucose and blood pressure for human beings.
Do NOT apply the cuff to areas other than your wrist.

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Detailed Information
Reference Values
Blood glucose monitoring plays an important role in diabetes con-
trol. A long-term study showed that keeping blood glucose levels
close to normal can reduce the risk of diabetes complications by
up to 60%*1. The results provided by this system can help you and
your healthcare professional monitor and adjust your treatment plan
to gain better control of your diabetes.
*1: ADA Clinical Practice Recommendations 2003.
Please consult your doctor to determine a target range that
works best for you.
Time of day
Fasting and before meal
2 hours after meals
Normal plasma glucose range for people
without diabetes (mg/dL)
Less than 100 mg/dL (5.6 mmol/L)
Less than 140 mg/dL (7.8 mmol/L)
Source: American Diabetes Association (2012). Clinical Practice Rec-
ommendations. Diabetes Care, 35 (Supplement 1): S1–S100.

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Blood Pressure
Clinical studies show that the diabetes in adult is often accompa-
nied by elevated blood pressure. People with diabetes can reduce
their heart risk by managing their blood pressure along with dia-
betes treatment*2. Knowing your blood pressure patterns can help
determine whether or not your body is in good condition. Human
blood pressure naturally increases after reaching middle age. This
symptom is a result of continuous aging of the blood vessel.
Other causes include obesity, lack of exercise, and cholesterol
(LDL) adhering to the blood vessels. Rising blood pressure accel-
erates hardening of the arteries, making the body becomes more
susceptible to apoplexy and coronary infarction. The WHO (World
Health Organization) published the following guidelines for blood
pressure range:
Source:1999 WHO/ISH guidelines for the management of hypertension.
*2: American Diabetes Association: The Diabetes-Heart Disease Link Sur
veying Attitudes, Knowledge and Risk (2002).
80
120
130
140
160
180
85 90 100 110
Optimal
High-Normal
Normal
Grade 1 Hypertension (“mild”)
Grade 2 Hypertension (“moderate”)
Grade 3 Hypertension (“severe”)
(mmHg)
Systolic
Diastolic

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ABOUT THIS SYSTEM
Intended Use
The FORA D10 system is a 2 in 1 system designed to measure
blood glucose outside of human body and to measure blood pres-
sure non-invasively. It is intended for use in the home and in clinical
settings. It shall not be used for the diagnosis of diabetes and hyper-
tension, or for the testing of newborns.
The talking functions on the meter is not intended for use by visually
impaired users.
AST of this system can be used only during steady-state blood glu-
cose conditions as described in the section of “Alternative Site Test-
ing (AST)".