BIONIME Rightest ALPHA Manuale utente
101-3GM551-060
EN
Rev. Date: 2021-06
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: EmergoVig[email protected]
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
Email: [email protected]om
http://www.bionime.com
Made in Taiwan
User’s Manual
ALPHA
Blood Glucose Monitoring System
Thank you for choosing the RIGHTEST ALPHA Blood Glucose Monitoring System. Please read this
manual thoroughly before testing. It provides all information you need to use the product.
The RIGHTEST ALPHA Blood Glucose Meter must only be used with RIGHTEST ALPHA Blood
Glucose Test Strip and RIGHTEST Control Solution. The application of other Test Strips or control
solutions can lead to incorrect results.
We hereafter call RIGHTEST ALPHA Blood Glucose Meter as RIGHTEST ALPHA Meter, and
RIGHTEST ALPHA Blood Glucose Test Strip as RIGHTEST ALPHA Test Strip for short.
It is recommended to monitor blood glucose regularly. RIGHTEST ALPHA Blood Glucose Monitoring
System is accurate and easy-to-use and is thus your reliable assitant for diabetes management.
RIGHTEST ALPHA Blood Glucose Monitoring System is manufactured and supported by Bionime
Corporation. If you have any question or concern, please contact your local Bionime Customer
Service or email to [email protected].
The RIGHTEST ALPHA Blood Glucose Monitoring System is designed for in vitro diagnostic (for
testing outside the body) use only and can be used by home user and healthcare professional.
The system can test glucose concentration in fresh capillary whole blood (drawn from fingertip, palm
and forearm). The glucose result displayed is calibrated into the plasma glucose testing equivalent.
The system is not intended for screening or diagnoses of diabetes mellitus.
Preface
32
Intended Use
- Before using RIGHTEST ALPHA Blood Glucose Monitoring System to test your blood glucose,
please read all of the info and conduct all of the tests including the quality control test.
- We recommended you to perform the quality control test regularly to ensure the test results are
accurate.
- The RIGHTEST ALPHA Meter can only be used with RIGHTEST ALPHA Test Strip. Other brands' test
strips should not be used under any circumstances. The use of other brands' strips may give
inaccurate results.
- If RIGHTEST Meter and Test Strips are exposed to temperature environments out of range for the
meter – below 10°C (50°F) or above 40°C (104°F) – please wait at least 30 minutes before testing
again.
- Follow all environmental protection regulations when disposing of batteries, strips and lancets.
- RIGHTEST Blood Glucose Monitoring System has not been validated for use on neonates. DO NOT
use it test for neonates.
- RIGHTEST Blood Glucose Monitoring System is NOT intended for arterial blood testing.
- Avoid contact with dripping or splashing liquids.
- Once patient is suspected as rare disease (e.g. galactosemia), the glucose result should basedon
laboratory test.
54
Caution Caution
- The minimum blood sample size for testing is 0.75 µL :( )
Blood sample size above 3.0 µL might contaminate the test strip port and the meter.
Blood sample size below 0.75 µL may cause an inaccurate result or may prevent a meter reading.
An Er4 reading will be displayed if the sample size is too small. In this case, repeat the test with a
new test strip.
Sample Size Example 0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
Important Safety Notes
- All parts of the kit are considered biohazardous and can potentially transmit infectious
diseases, even after following the cleaning and disinfecting procedures. Please refer to the
section "Maintain the products" on page 35.
- Users should wash their hands thoroughly with soap and water before and after handling the
meter, lancing device, or test strips.
76
About RIGHTEST ALPHA System
RIGHTEST ALPHA Blood Glucose Monitoring System
RIGHTEST ALPHA Meter
RIGHTEST ALPHA Test Strip
Table of Contents Table of Contents
16
18
22
8
10
14
Being Ready for Test
Meter activation and Battery change
Setting Up Your Meter- Setting the Time Date, Volume and Test Unit
Turning On / Off the Meter
Testing Procedure
Performing a Blood Test
Alternative Site Testing (AST)
View window appearance
23
27
29
Quality Control Test 31
Quality Control
"Lo" and "Hi" readings
Error Messages and Trouble Shooting
Specification
Limitations
Customer Service
Warranty
42
46
48
49
50
Review Your Test Memory
Performing a Quality Control Test
Maintain the products
Recalling Test Result and Average
33
39
35
30
98
7＊
32
4＊
1
5＊
6＊
RIGHTEST ALPHA Blood Glucose Monitoring System
Your RIGHTEST ALPHA Blood Glucose Monitoring System consists of several items. Please identify
each item and make sure you understand how to use them.
The following items are included in your RIGHTEST ALPHA Blood Glucose Monitoring System:
1. RIGHTEST ALPHA Blood Glucose Meter (with 1 CR2032 battery installed)
2. Instruction documents (Getting Started and User's Manual (includes Log Book, Warranty Card,
Emergency Card))
3. RIGHTEST ALPHA Blood Glucose Test strips (10/25 pcs)(with Insert)＊
4. RIGHTEST Control Solution GC570 (with Insert) ＊
5. RIGHTEST Lancing Device GD500 (with Insert) ＊
6. Clear Cap ＊
7. Disposable Sterile Lancets (10 pcs) ＊
8. Carrying Case (not shown)＊
(＊Different packages have different bundled items. Some of packages might not include＊items.)
RIGHTEST ALPHA Blood Glucose Monitoring System
1110
Left Button ( )
For operating the meter, please
check details in following sections.
Main Button ( )
For operating the meter, please
check details in following sections.
RIGHTEST ALPHA Meter
Display Window
Show your test result, messages
and relative information.
Test Strip Port
Insert test strip here until you hear a
click.
Right Button ( )
For operating the meter, please
check details in following sections.
Battery Cover
Slide cover to change
batteries.
Meter Label
RIGHTEST ALPHA Meter
Meter Battery
Do not put
battery here.
1312
Indicates a test result stored in memory
Indicates a test result, not joining into the Average
function of this meter
Indicates with the average result
Indicates a control solution test result
Unit of test result
Test result
Warns when the battery is low or must be replaced
Tell when to apply the blood sample
Test strip
Indicate error happens
Current date under time mode or Testing date
under memory mode
Indicates if the environmental temperature is
exceeded during testing
Indicates the time in 12H format
Current time under time mode or Testing time
under memory mode
Manufacturing use only
RIGHTEST ALPHA Meter RIGHTEST ALPHA Meter
1514
View Window
This window is yellow before applying
blood sample. It gradually turns red
when filled with blood.
Hand Bar
Grip here to insert
test strip into meter.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 of blood. µL
Electrode Contacts
Sensing signal output terminals.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with indication symbol
up and toward meter.
The RIGHTEST ALPHA Meter must only be used with RIGHTEST ALPHA Test Strip and RIGHTEST
Control Solution.
The application of other Test Strips or control solutions can lead to incorrect results.
PRECAUTION
- Close the test strip vial immediately after taking out a test strip.
- Do not reuse test strips. Test strip can be only used once.
- Do not use expired test strips.
- Every time when you open a new vial of test strips, please write the opening date on the
label. Use test strips within 3 months after opened or until the expiration date printed on the
label (whichever comes first).
- Store the test strips in 4 - 30°C (39 - 86°F) and with 10 - 90% relative humidity. Do not
expose to direct sunlight or heat.
- For detailed information, please refer to the RIGHTEST ALPHA Test Strip Insert.
- If the RIGHTEST ALPHA Meter or strips are exposed to a substantial change in temperature.
please wait at least 30 minutes before testing again.
RIGHTEST ALPHA Test Strip RIGHTEST ALPHA Test Strip
1716
Meter activation and Battery Change
1. Turn the meter over.
Press and push battery
cover to open.
PRECAUTION
- Please follow the local regulations and discard a used battery properly.
4. The meter performs a self test.
5. Press any button to exit the self-test and enter Setting Mode.
6. Set the time and date when the batteries are replaced. See Chapter "Setting up your meter -
setting the time, volume and date". Test results are still stored in the memory.
3. Slide the battery cover
back until it snaps into
place.
2. Install the battery. Be sure
to put battery in correct way
with the "+" symbol up.
Meter activation and Battery change
Your meter comes with 1 CR2032, 3 volt, batteries installed. A new batteries will provide power to
perform about 1,000 tests under normal use. You can press the main button or insert a strip to
activate your meter.
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