FOR-A D10 Manuale utente

FORA D10

BLOOD GLUCOSE

PLUS BLOOD PRESSURE

MONITORING SYSTEM

English

311-3224100-006

Version 4.0 2012/12

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.

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

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

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

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

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.

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.

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).

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

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)".

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