ForaCare D20 No-Coding Manual de usuario

Dear System Owner:

Thank you for purchasing the ForaCare D20 No-Coding Blood

Glucose plus Blood Pressure Monitoring System. This manual

provides important information which helps you to operate this

system smoothly. Before using this product, please read the follow-

ing contents thoroughly and carefully.

According to the clinical studies from American Diabetes Associa-

tion, 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 op-

eration of this ForaCare D20 No-Coding Blood Glucose plus Blood

Pressure Monitoring System, you can easily monitor your blood

glucose levels and blood pressure by yourself at any place, any

time. In addition, this system can help you and your healthcare

professionals to monitor and adjust your treatment plans, and

keep your diabetes and blood pressure under control.

If you have other questions regarding this product, please contact

the place of purchase.

Version 4.0 2013/01 311-3263100-006

English

IMPORTANT SAFETY PRECAUTIONS

READ BEFORE USE

●The meter and lancing device are for single patient use. Do not share

them with anyone including other family members! Do not use on

multiple patients!

●All parts of the kit are considered biohazardous and can potentially

transmit infectious diseases, even after you have performed cleaning

and disinfection.

For more information, please visit

1.“FDA Public Health Notiﬁcation: 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 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 damaged.

4. Do NOT use the equipment where aerosol sprays are being used or

where oxygen is being administered.

5. Do NOT use under any circumstances 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. Do all quality control checks as

directed.

8. Keep the device and testing supplies away from young children. Small

items such as the battery cover, batteries, test strips, lancets and vial

caps are choking hazards.

9. Keep the equipment 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 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.

12. Do NOT use this device in close proximity to sources of strong electro

magnetic radiation, as these may interfere with the correct operation.

13. Proper maintenance and periodically calibration are essential to the

longevity of your device. If you are concerned about your accuracy of

measurement, please contact local customer service for help.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

IMPORTANT SAFETY PRECAUTIONS 02

BEFORE YOU BEGIN 06

Important Information 06

Intended Use 07

Test Principle 07

Contents of System 08

Monitor Overview 09

Screen Display 10

Test Strip 11

Speaking Function 12

SETTING THE MONITOR 14

TESTING YOUR BLOOD GLUCOSE 18

Control Solution Testing 18

Performing a Control Solution Test 19

TESTING WITH BLOOD SAMPLE 22

Preparing the Lancing Device for Blood Testing 22

Preparing the Puncture Site 23

Alternative Site Testing 25

Performing a Blood Glucose Test 27

TESTING YOUR BLOOD PRESSURE 30

Before Measurement 30

Taking a Single Measurement 33

MONITOR MEMORY 34

Reviewing Test Results 34

Reviewing Day Average Results 35

DOWNLOADING RESULTS ONTO A COMPUTER 36

MAINTENANCE 37

Battery 37

Using AC Adapter 39

Caring for Your Monitor 40

Caring for Your Test Strips 43

Important Control Solution Information 44

SYSTEM TROUBLESHOOTING 45

Result Readings 45

Error Messages 46

Troubleshooting 48

DETAILED INFORMATION 51

Reference Values 51

Comparing Monitor and Laboratory Results 53

SPECIFICATIONS 55

BEFORE YOU BEGIN

Important Information

•Severe dehydration and excessive water loss may cause readings

which are lower than actual values. If you believe you are suffering

from severe dehydration, consult a healthcare professional

immediately.

•If your blood glucose results are lower or higher than usual, and

you do not have symptoms of illness, ﬁrst repeat the test. If you

have symptoms or continue to get results higher or lower than

usual, follow the treatment advice of your healthcare professional.

•Use only fresh whole blood sample to test your blood glucose.

Using other substances will lead to incorrect results.

•If you are experiencing symptoms that are inconsistent with your

blood glucose test results and you have followed all instructions

described in this owner’s manual, call your 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 the healthcare professional before use.

Intended Use

This system is a 2 in 1 system designed to measure blood glucose

outside the human body (in vitro diagnostic use) and to measure

blood pressure non-invasively. It is intended for use at home as an aid

to monitoring the effectiveness of diabetes control.

It shall not be used for the diagnosis of diabetes and hypertension, or

for the testing of neonates. It is intended to be used by a single person

and should not be shared.

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. Your

monitor measures the current, calculates the blood glucose level, and

displays the result. The strength of the current produced by the reac-

tion 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 arterial or ventricular premature beats or

arterial ﬁbrillation. It may produce reading errors.

Contents of System

Your new ForaCare D20 No-Coding system kit includes:

Test strips, control solutions, lancing device or sterile lancets may not

be included in the kit (please check the contents on your product box).

They 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 before use, please contact

local customer service or place of purchase for assistance.

1 432

6Warranty Card

Lancing Device with One Clear Cap

(Optional)

4 x 1.5V AA alkaline batteries

Protective Storage Case

Monitor

Owner’s Manual

Pressure Cuff (arm type)

Quick Start User Guide

Daily Log Book

65 8 97

Monitor Overview

Front Back Side

Test Slot

Insert test strip here to turn the

monitor on for testing.

Display Screen

C Button

Enter control solution test.

On/Off Button

To start a single NIBP measurement.

Speaker

M Button

Enter the monitor memory.

S Button

Enter and conﬁrm the monitor

settings.

AC/DC Adapter Port

Connect to a power supply.

Battery Compartment

USB Link Port

Download test results with

a cable connection.

Air Plug

Connect to air jack.

Air Tube

Pressure Cuff

Air jack

1 8

7 9

Screen Display

Test Strip Symbol

Volume Symbol

Code Number

Special Message

Systolic Pressure Value

Battery Symbol

Indicator Symbol

Heart Symbol

Pulse Rate

Day Average Result

Diastolic Pressure Value

Memory Mode Symbol

Control Mode Symbol

Diastolic Pressure Symbol

Blood Drop Symbol

Unit for Blood Pressure

Unit for Blood Glucose

Systolic Pressure Symbol

Date/Time

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