MediVena ONE-CARE PRO Guide de référence

ONE-CARE® PRO Blood Glucose Monitoring System

(Model AC500 PRO)

For in vitro diagnostic use only

Operations & Procedures Manual

Introduction

Intended Use Statement

Important Safety Instructions

About the Product

About the Meter

About the Meter Display

About the Test Strip

About the Test Strip Vial

Installing/Replacing the Battery

Setting Up the Meter

Setting the Date, Time

Setting the Reminder Alarm

Setting the HI / LO Alarm

Setting the Sound

Important Information

Testing Your Blood Glucose Level

Preparing the Test Strip

Obtaining a Blood Sample

Applying Blood Sample to the Test Strip

Available Alternate Sites Testing: Palm and Forearm

Control Solution Test

Memory Features

Transfer Test Results to a Computer

Cleaning and Disinfection Procedures

Care and Storage

Display Messages

Other Problems that May Occur

Specications

Icon Description

Tolerance summary of Interference Substance

Service and Warranty

Customer Service

TABLE OF CONTENT

INTRODUCTION

Thank you for choosing the ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System.

As you already know, self monitoring of blood glucose (SMBG) is a necessary part of the treatment

plan of people with diabetes mellitus. Adapted for its ease of use and quick response time, the

ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System has the ability to process

accurate results utilizing only a small volume of blood for in vitro diagnostics.

The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System is been designed with

auto coding feature. It means the meter will code itself automatically every time you insert a test

strip.

Please read the entire User’s Manual carefully before using this product.

INTENDED USE STATEMENT

The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System is Intended to be used

for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from ngertip,

palm, or forearm. The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System is

intended for testing outside the body (in vitor diagnostic use) and is intended for multiple-patient

use in professional healthcare settings as an aid to monitor the eectiveness of diabetes control

program. This system should only be used with auto disabling, single-use lancing devices.

The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System should not be used for

the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done

only during steady-state times (when glucose is not changing rapidly).

The ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Test Strips are for use with the ONE-CARE®

PRO (Model AC500 PRO) Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh

capillary whole blood samples drawn from the ngertips, forearm or palm.

• 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 transmit-

ting bloodborne pathogens between patients and healthcare professionals. For more information,

refer to “Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health-

care 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.

Cleaning Solution and Disinfecting Solution: CaviCide Surface Disinfectant (Metrex Research Co.,

EPA Reg. No. 46781-6) For more product information, contact Metrex at 1-800-841-1428 or visit

website at www.metrex.com.

IMPORTANT SAFETY INSTRUCTIONS

ABOUT THE PRODUCT

Your ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring System is made up of several

components. This booklet is designed to guide you through the operation of the system with

detailed directions and pictures. Your ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Monitoring

System contains:

˙ONE-CARE® PRO (Model AC500 PRO) Blood Glucose Meter

˙ONE-CARE® PRO (Model AC500 PRO) User Manual

Note: 50 test strips vial can be purchased individually.

1. Test Port

2. Strip Eject Button

3. Display

4. M Button

5. ▼Button

6. ▲Button

7. Battery Cover

8. Label

9. Data Port

(Side of the meter)

ABOUT THE METER

Insert the test strip here.

Press this button to ejects the test strip.

Shows blood glucose results and messages.

Press this button to set the year/date/time; to view results and test average

in memory; to enter control solution test mode or to turn the meter o.

Press this button to decrease number/move forward in meter setting.

Press this button to set the reminder alarm and HI / LO alarm.

Press this button to increase number/move backward in meter setting.

Slide cover to install and replace batteries.

Contains meter serial number and customer service phone number.

Connect interface cable to transfer data.

Front view Back view

(Model: AC500 PRO)

MediVena

1 Glenlake Pwy, Ste 700

Atlanta, GA 30328, USA

[email protected]

TOLL FREE:

+1 888 270 6457

Manufactured for:

Manufacturado para:

ONE-CARE PRO

Blood Glucose Meter

Medidor de Glucosa

4001-00 Rev.00

0123456789

AL001-0199000N(01)

1. Memory Symbol

Indicates in memory mode.

2. Control Solution Test

Appears when doing a control solution test and marking the result as a control solution test.

3. Date

4. Test Result Area

Display test results.

5. Alarm Function Symbol

Appears when the clock alarm is set.

6. Buzzer Icon

Appears when buzzer is ON

7. Meal Indicator

Pre-meal and post-meal

8. Day Average Symbol

Shows the average value of test results.

9. Time

10. Blood Drop Symbol

Flashes when it is ready to apply sample to test strip.

11. Warning Symbol

Appears when result is out of the range of your setting reference value.

12. Test Strip Symbol

Appears to tell you when the meter is ready for test.

13. Unit of Measurement

Unit of mg/dL will appear with the test result

14. Temperature Message

Appears if your meter is out of operating temperature range.

15. Battery Symbol

Appears when the battery is low or must be replaced.

ABOUT THE METER DISPLAY

ABOUT THE TEST STRIP

Each strip can be used only once.

The test strip consists of the following parts:

1. Target Area

This is where blood is drawn into the test strip.

2. Conrmation Window

This is where you can conrm that enough blood has been applied to the target area.

3. Contact Bar

This end of the test strip is inserted into the test port to activate the meter. (white side face up).

ABOUT THE TEST STRIP VIAL

31-61

86-146

263-353

Tiras Reactivas para Glucosa en Sangre

Blood Glucose Test Strips

Store at 39 ~ 86°F (4 ~ 30°C), Do not refrigerate

Use within 90 days after opening

Do not store test strips outside this vial

Re-cap immediately

Use only with

One-Care Pro (Model: AC500 PRO) Blood Glucose Meter!

ONE-CARE PRO

Almacenar a 39 ~ 86°F (4 ~ 30°C), No refrigerar

Una vez abierto usar en 90 días

No guardar las tiras fuera de este vial

Tapar inmediatamente

¡Usar solo con

ONE-CARE®

PRO Medidor de Glucosa en Sangre (Modele: AC500 PRO)!

Manufactured for / Manufacturado para:

MediVena, 1 Glenlake Pwy, Ste 700

Atlanta, GA 30328, USA

[email protected]

TOLL FREE: +1 888 270 6457

4008

4008-00 Rev. 00

(Model: AC500 PRO)

Test Strip Vial

Test Strip Vial Label

Tiras Reactivas para Glucosa en Sangre

Blood Glucose Test Strips

Store at 39 ~ 86°F (4 ~ 30°C), Do not refrigerate

Use within 90 days after opening

Do not store test strips outside this vial

Re-cap immediately

Use only with

One-Care Pro (Model: AC500 PRO) Blood Glucose Meter!

ONE-CARE PRO

Almacenar a 39 ~ 86°F (4 ~ 30°C), No refrigerar

Una vez abierto usar en 90 días

No guardar las tiras fuera de este vial

Tapar inmediatamente

¡Usar solo con

ONE-CARE®PRO Medidor de Glucosa en Sangre (Modelo: AC500 PRO)!

Manufactured for / Manufacturado para:

MediVena, 1 Glenlake Pwy, Ste 700

Atlanta, GA 30328, USA

[email protected]

TOLL FREE: +1 888 270 6457

Control Solution Range:

Rango Solución Control:

4008

4008-00 Rev. 00

(Model: AC500 PRO)

INSTALLING/REPLACING THE BATTERY

When the battery is low, the meter will show a warning signal. When this display appears, it is time

to replace a new battery. When the low battery warning signal is shown, the meter will provide

accurate results for approximately 50 more measurements.

How to Replace the Battery

1. From the back of the meter, gently slide and remove the battery cover.

2. Insert the batteries (two AAA) with the + and – ends matching the marks in the battery compartment.

3. Slide battery cover back into place.

SETTING UP THE METER

To turn the meter on, rst install the batteries, then proceed with the following instructions.

SETTING THE DATE, TIME

1. Press and hold M for 4 seconds with meter turn o to enter this mode.

2. Press ▲or ▼to select “24hr” or “12hr” setting. Press M to set. (Fig.1)

3. The year will now appear and ash. Press ▲or ▼to select the year. Press M to set. (Fig.2)

4. The number in the month position will now ash. Press ▲or ▼to select the month. Press M to

set. (Fig.3)

5. The day will now ash. Press ▲or ▼to select the date. Press M to set. (Fig.3)

6. The number in the hour position will now ash. Press ▲or ▼to select the hour. Press M to set.

(Fig.4)

7. The minute will now ash. Press ▲or ▼to select the minute. Press M to set. The date and time

you set will show on the display screen. Press M to turn o the meter. You have now completed

the meter date/ time setting. (Fig.4)

(Fig.1) (Fig.2) (Fig.3) (Fig.4)

SETTING THE REMINDER ALARM

The meter provides four user setting reminder alarms for worry free testing. (Default is alarm o.)

1. Press and hold ▼for 4 seconds with meter turn o to enter this mode.

2. The rst reminder alarm will appear on the display. (Fig.5). Press ▲or ▼to seclect which alarm

you want to set (number 1 to 4). Press Mto conrm.

3. Press ▲or ▼to select “YES”or“NO”. If “NO” is chosen and Mis pressed, the meter goes back to

reminder alarm setting mode. If “YES” is chosen, press Mto conrm and the time will appear. (Fig.6)

4. The number in the hour position will now ash. Press ▲or ▼to seclect hour. Press Mto set.

(Fig.7)

5. The minutes will now ash. Press ▲or ▼to select the minutes. Press Mto set and meter will goes

to reminder alarm setting. (Fig.8)

6. Press ▲or ▼to seclect reminder alarm 2 to 4. Repeat steps 3 to 5 to set the next three reminder

alarms. (if needed).

7. After nishing reminder alarm setting, HI alarm setting appear.

NOTE:

When the alarm is ringing, press any one button to turn o or the alarm will turn o automati-

cally after 30 sec.

(Fig.5) (Fig.6) (Fig.7) (Fig.8)

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