BIONIME RIGHTEST Max Bedienungsanleitung
101-3GM770-020
EN
User’s Manual
Max
Rev. Date: 2019-05
0197
Blood Glucose Monitoring System
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: +886 4 2369 2388
Fax: +886 4 2261 7586
http: //www.bionime.com
E-mail: [email protected]om
Made in Taiwan
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
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Indication for use
Thank you for using our product, this manual provides all the information you need to operate this
product for accurate test results. Please read this entire manual before you start any testing.
For people living with diabetes, it is important to regularly monitor blood glucose level to effectively
reduce complications from diabetes. The easy-use RIGHTEST Max Blood Glucose Monitoring
System provides accurate, reliable test results to help you better manage your diabetes.
You may consult your healthcare professional for instructions on how to use the system correctly.
Our customer service information is on the cover, our staff is willing to assist you as well. Please
contact healthcare professional if emergency or our service is not available. Please forward your
warranty card to customer support to activate your warranty coverage.
RIGHTEST Max Blood Glucose Monitoring System is made and supported by Bionime Corporation.
If you have any questions or concerns, please contact your local Bionime Customer Service or
email to [email protected]
RIGHTEST Max Blood Glucose Monitoring System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh whole blood samples from capillary. The testing result is
calibrated to plasma equivalent with whole blood from capillary, vein, artery and neonates. Capillary
whole blood can be sampled from the fingertip, palm or forearm, and in the case of neonates, the
heel.
RIGHTEST Max Blood Glucose Monitoring System is intended for self-testing outside the body (in
vitro diagnostic use), they can be used as an aid of diabetes control for home user or professional.
RIGHTEST Max Blood Glucose Monitoring Systems should not be used for the diagnosis of, or
screening for diabetes. Alternative site testing should be done only during steady - state times
(when glucose is not changing rapidly).
RIGHTEST Max Control Solution is for use with RIGHTEST Max Blood Glucose Meter and
RIGHTEST Max Blood Glucose Test Strip to check that the meter and test strips are working
together properly and that the test is performing correctly.
Scan the QR code to view the guide video.
Preface
54
Caution Caution
- Before using RIGHTEST Max 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 (Refer to page 45).
- Please perform the quality control test regularly to make sure the test results are fine.
- RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test
Strip. Other brands’ test strips should not be used under any circumstances. The use of other
brands’ strips may give inaccurate results.
- RIGHTEST Max Blood Glucose Monitoring System is intended for in vitro diagnostic use only. The
testing result is calibrated to plasma equivalent with whole blood from capillary, vein, artery and
neonates. Capillary whole blood can be sampled from the fingertip, palm or forearm.
- Venous, neonatal or arterial blood testing should be performed by healthcare professionals.
- RIGHTEST Max Blood Glucose Monitoring System is NOT intended for diagnosis of diabetes
mellitus.
- If RIGHTEST Meter and Test Strips are exposed to temperature environments out of range for the
meter – below 6°C (43°F) or above 44°C (111°F) – please wait 30 minutes before testing again.
- Follow all environmental protection regulations when disposing of batteries, strips and lancets.
- Avoid contact with dripping or splashing liquids.
- The minimum blood sample size to test using RIGHTEST Max Blood Glucose Monitoring System
0.75 : ( )µL
- Please follow the recommendations for follow-up care that have been set by the professional
medical staff for critical glucose values in neonates.
- As a matter of good clinical practice, be caution of the interpretation of neonate glucose value
below 50 mg/dL (2.8 mmol/L).
- Once patient is suspected as rare disease (e.g. galactosemia), the glucose result should based
on laboratory test.
Sample Size Example
Blood sample size above 3.0 might contaminate the test strip port and the meter.µL
Sample below 0.75 will cause Er4. In this case, repeat the test with a new test strip.µL
0.75 µL 1.0 µL 1.5 µL 2.0 µL 3.0 µL
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Limitations
Caution
- RIGHTEST Max Blood Glucose Monitoring System is not intended for serum or plasma testing.
- Do not use at altitudes greater than 10,000 feet (3,048 meters).
- Hematocrit levels below 10% may cause falsely high reading. Hematocrit levels over 70% may
cause falsely low reading. If you do not know your hematocrit level, consult your doctor or nurse.
- Severe dehydration and excessive water loss may cause inaccurately low results.
- The blood glucose test result may be affected by high blood concentration of interference
ingredients, if you need more detail information about interference ingredients, please see
RIGHTEST Max blood glucose test strip insert.
- Not for screening or diagnosis of diabetes mellitus.
- These test strips should not be used with meters to test critically ill patients.
- Alternative site testing (AST) should only be performed during steady-state times (when glucose is
not changing rapidly), please refer to the (Alternative site testing (AST)) chapter before you
perform AST testing.
- Alternative site testing should not be used to calibrate continuous glucose monitoring systems
(CGMS).
- To avoid potential electromagnetic or other interference, keep meter away from electromagnetic
radiation sources such as X-ray or MRI.
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 51.
- Users should wash their hands wholly with soap and water before and after touching the
meter, lancing device, or test strips.
Table of Contents Table of Contents
About RIGHTEST Max Blood Glucose Monitoring System
RIGHTEST Max Blood Glucose Monitoring System............................................................................
RIGHTEST Max Blood Glucose Meter.................................................................................................
RIGHTEST Max Blood Glucose Test Strip...........................................................................................
Before Testing
Meter Activation and Battery Change ...............................................................................................
Set Up Your Meter ..............................................................................................................................
Turning On / Off the Meter ..................................................................................................................
Handling RIGHTEST Max Blood Glucose Test Strip...........................................................................
Testing Procedure
Getting Ready for Testing ...................................................................................................................
Performing a Blood Glucose Test .......................................................................................................
Setting Markers ..................................................................................................................................
Recalling Test Results ........................................................................................................................
Recalling Average Test Results ..........................................................................................................
Alternative Site Testing........................................................................................................................
View Window Appearance..................................................................................................................
Understanding Test Results and Messages.......................................................................................
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12
16
18
20
26
27
29
30
35
36
38
40
42
43
Quality Control
About Quality Control Testing.............................................................................................................
Performing a Quality Control Test.......................................................................................................
Understanding Control Test Results...................................................................................................
Other Information
Maintain the Products.........................................................................................................................
Error Messages and Troubleshooting................................................................................................
Specification.......................................................................................................................................
Warranty..............................................................................................................................................
Customer Service................................................................................................................................
Expected Glucose Values...................................................................................................................
Component Manufacturer Information...............................................................................................
45
48
50
51
56
60
62
63
64
65
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8
RIGHTEST Max Blood Glucose Monitoring SystemRIGHTEST Max Blood Glucose Monitoring System
7＊
2 3＊1
4＊5＊6＊
Your RIGHTEST Max Blood Glucose Monitoring System consists of several items. Please identify
each item, learn its name and how it is used.
The items in RIGHTEST Max Blood Glucose Monitoring System:
1. User Documents (Getting Started Guide, User's Manual, Log Book, Warranty Card, Emergency
Card).
2. RIGHTEST Max Blood Glucose Meter (with battery installed)
3. RIGHTEST Max Blood Glucose Test strips 10 or 25 pcs (with Package Insert)
4. RIGHTEST Max Control Solution (with Package Insert)
5. RIGHTEST Lancing Device (with Package Insert)
6. Clear Cap
7. Disposable Sterile Lancets (10 pcs)
8. Carrying Case (not shown)
＊Different packages have different bundled items. Contact distributor for more details.
(＊- product sold separately)
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RIGHTEST Max Blood Glucose Meter
Up Button ( )
Down Button ( )
Main Button ( )
Display Window
Test Strip Port
RIGHTEST Max Blood Glucose Meter
Battery Cover
Do not put
battery here.
Meter Battery
Pen press to
open the
Cover.
Meter label
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RIGHTEST Max Blood Glucose Meter RIGHTEST Max Blood Glucose Meter
Indicates a control solution test result.
Unit of test result.
Indicates when to apply the blood sample.
Appears after you insert test strip into meter.
Current date under time mode or testing date
under memory mode.
Warns when the operational temperature limit is
exceeded during testing.
Indicates the time format is 12H.
Displays current time under time mode or testing
time under memory mode.
Warns when the battery is low or must be
replaced.
Indicates a meal marker with test result.
Indicates that the Bluetooth is enabled
( meter ).Bluetooth only
Indicates a test result stored in memory. Indicates a testing result is waiting for transmission.
(Bluetooth meter only)
Test result.
Indicates the alarm setting.
Indicates the average result.
Appears when a test result is above 240 mg/dL
to suggest ketone testing.
The blood glucose result is within the target
range.
The blood glucose result is below the target range.
The blood glucose result is above the target range.
Indicates wake up.
exercise marker with test result.
Before sleep marker with test result.
Indicates midnight.
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Manufacturing use only.
RIGHTEST Max Blood Glucose Meter can only be used with RIGHTEST Max Blood Glucose Test
Strip and RIGHTEST Max Control Solution. The use of other test strips or control solutions can lead
to incorrect results.
RIGHTEST Max Blood Glucose Test Strip RIGHTEST Max Blood Glucose Test Strip
PRECAUTION
- Close the vial rapidly after taking out a test strip.
- Do not reuse RIGHTEST Test Strip.
- Do not use expired RIGHTEST Test Strip.
- Record the date of opening a new RIGHTEST Test Strip vial for the first time. Discard the
vial of test strips after 12 months from opening.
- Store RIGHTEST Test Strip in 4 - 30°C (39 - 86°F) and with < 90% relative humidity. Do not
expose to direct sunlight or heat.
- If RIGHTEST Meter and Test Strips are exposed to a temperature environments out of
range for the meter – below 6°C (43°F) or above 44°C (111°F) – please wait 30 minutes
before testing again.
- For detailed strip information, please refer to RIGHTEST Max Blood Glucose Test Strip
Insert.
Sample Entry
Apply a drop of blood or control solution here.
The test request is only 0.75 µL of blood.
Hand Bar
Grip here to insert
test strip into the
strip port of auto
code key.
View Window
This window is yellow
before applying blood
sample. It turns red when
filled with blood.
Noble Metal Electrodes
Electrochemical sensor
Indication Symbol
Insert strip with the symbol facing up.
Electrode Contacts
Sensing signal output terminals.
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