MediVena ONE-CARE PRO Guía de referencia

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
Specications
Icon Description
Tolerance summary of Interference Substance
Service and Warranty
Customer Service
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TABLE OF CONTENT
01

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 eectiveness 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.
02

• 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.
03

7
8
9
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
M
4
5
1
3
6
2
(Model: AC500 PRO)
MediVena
1 Glenlake Pwy, Ste 700
Atlanta, GA 30328, USA
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)
04

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
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1
05

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. Conrmation Window
This is where you can conrm 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
TOLL FREE: +1 888 270 6457
4008
4008-00 Rev. 00
(Model: AC500 PRO)
Test Strip Vial
1
2
3
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
TOLL FREE: +1 888 270 6457
Control Solution Range:
Rango Solución Control:
10
4008
4008-00 Rev. 00
(Model: AC500 PRO)
06

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.
07

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)
08

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 conrm.
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 conrm 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)
09
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