Future Diagnostics CareTouch Bedienungsanleitung

Blood Glucose and ß -Ketone Monitoring System

Owner’s Manual

English

Dear Care Touch System Owner:

Thank you for choosing the Care Touch Blood Glucose and ß-Ketone

Monitoring System. This manual provides important information to

help you to use the system properly. Before using this system, please

read the following contents thoroughly and carefully.

The System measures blood glucose, and ß-ketone. Regular

monitoring of your blood glucose and ß-ketone levels can help you and

your doctor gain better control of your diabetes. Due to its compact

size and easy operation, you can use the Care Touch Blood Glucose

and ß-Ketone Monitoring System to easily monitor your blood glucose

and ß-ketone levels by yourself anywhere, any time.

If you have other questions regarding this product, please contact

the local customer service or place of purchase.

Intended Use

Care Touch Blood Glucose and ß-Ketone Monitoring System is

intended for the quantitative measurement of glucose in fresh capillary

whole blood from the finger, and for the quantitative measurement of

ß- ketone (beta-hydroxybutyrate) in fresh capillary whole blood from

the finger. The Care Touch is intended for in vitro diagnostic use and is

intended for single-patient use as an aid to monitor the effectiveness of

a diabetes control program. The system should not be used for the

diagnosis of or screening for diabetes.

Version 1.0

2017-03

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/ucm

224025.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 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. Do NOT under any circumstances use the device on neonates

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, 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. Do not use this instrument in close proximity to sources of strong

electromagnetic radiation, as this may interfere with the accurate

operation.

10.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 your local

customer service or place of purchase for help.

KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS

BEFORE YOU BEGIN

Important Information

Test Principle

Contents of System

Meter Overview (awaits update)

Display Screen

Test Strip

SETTING THE METER

THE FOUR MEASURING MODES

BEFORE TESTING

Calibration

How to Code Your Meter (for ß-Ketone)(b)

Checking the Code Number

Control Solution Testing

Performing a Control Solution Test

TESTING WITH BLOOD SAMPLE

Preparing the Lancing Device for Blood Testing

Preparing the Puncture Site

Performing a Blood Glucose / ß-Ketone Test

METER MEMORY

Reviewing Test Results

Reviewing Blood Glucose Day Average Results

DOWNLADING RESULTS TO A COMPUTER

Data transmission via cable

MAINTENANCE

Battery

Caring for Your Meter

Disinfecting Procedures

Caring for Your Test Strips

Important Control Solution Information

SYSTEM TROUBLESHOOTING

Result Readings

Error Messages

Troubleshooting

Reference values

Comparing Meter and Laboratory Results

SYMBOL INFORMATION

SPECIFICATIONS

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 or ß-ketone are lower or higher than

usual, and you do not have any symptoms of illness, first repeat

the test. If you have symptoms or continue to get results which are

higher or lower than usual, follow the treatment advice of your

healthcare professional.



Use only fresh whole blood samples to test your blood glucose or

ß-ketone. Using other substances will lead to inaccurate results.



If you are experiencing symptoms that are inconsistent with your

blood glucose or ß-ketone test results and you have followed all

the instructions given in this owner’s manual, contact your

healthcare professional.



The device should not be used 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.



Limitation

The device should not be used on individuals in hyperglycemic-

hyperosmolar state, with or without ketosis; not for neonatal use;

not for use on critically ill patients.

Test Principle

Your system measures the amount of sugar (glucose) or ß-ketone in

whole blood. The glucose or ß-ketone testing is based on the

measurement of electrical current generated by the reaction of glucose

or ß-ketone with the reagent of the strip. The meter measures the

current, calculates the blood glucose or ß-ketone level, and displays

the result. The strength of the current produced by the reaction

depends on the amount of glucose or ß-ketone in the blood sample.

Contents of System

Your new blood glucose and ß-ketone monitoring system kit includes:

1. Meter

2. Owner’s Manual

3. Protective Wallet

4. Quick Start User Guide

Test strips (d), control solutions (e), sterile lancets (g) or lancing device

(f) are not included in the kit. They must be purchased separately. Please

make sure you have those items needed for a test beforehand.

NOTE:

If any items are missing from your kit or opened prior to use, please

contact local customer services or place of purchase for assistance.

Meter Overview (awaits update)

1. Test Strip Slot & Strip Indicator

Insert test strip here to turn the meter on for

testing.Connect strip port cable for data transmission.

2. Test Strip Ejector

Eject the used strip by pushing up this button.

3. Display Screen

4. M Button (M)

Enter the meter memory and silence a reminder alarm.

5. Battery Compartment

6. SET Button (S)

Enter and confirm the meter settings.

Andere Handbücher für CareTouch

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