user manual
V200
Fluorescent Immunoassay systems
For veterInary use only
VC7402EA
Doc. No.: I7402-2E(CE)
Issued date : Sep. 05, 2017
Authorized Representative
Altenhofstrasse 80 D-66386 St. Ingbert Germany
Tel: +49-6894-581020 l Fax: +49-6894-581021
Manufactured by
Head oce
C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu,
Suwon-si, Gyeonggi-do, 16690, Republic of Korea
Manufacturing site
74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,
Cheongju-si, Chungcheongbukdo, 28161, Republic of Korea
Tel: +82-31-300-0400 l Fax: +82-31-300-0499
www.sdbiosensor.com
Distributed by
22, Samsung 1-ro 4-gil, Hwaseong-si, Gyeonggi-do 18449,
Republic of Korea
Tel: +82-31-211-0516 l Fax: +82-31-8003-0618
www.bionote.co.kr
Thank you for your purchase of the BIONOTE V200
This user manual contains all the information needed to use the analyzer and keep it ready to operate. Please read this
user manual carefully before using the analyzer. Familiarize yourself with the required preparations and the measurement procedure before performing the rst measurement. Please read the insert included in each test device package
before you try testing.
If you have any questions about the analyzer, please contact your healthcare professional or local distributor. You can also
visit www.bionote.co.kr for product demonstrations.
Thank you again for choosing the BIONOTE V200.
TABLE OF CONTENTS
CHAPTER 01. General Information
Main Menu Structure ........................................................................................................................................ 6
Symbols and Abbreviation ..............................................................................................................................10
Brief Precautions and Limitations...................................................................................................................12
CHAPTER 02. Introduction
Intended Use ...................................................................................................................................................13
Product Description ......................................................................................................................................... 13
Before You Start Testing ..................................................................................................................................13
System Components .......................................................................................................................................15
CHAPTER 03. Settings and Performance
Operating the Analyzer ...................................................................................................................................19
Performing a Measurement ...........................................................................................................................34
CHAPTER 04. Using the Analyzer Memory and Data Transfer
Displaying Stored Measured Values................................................................................................................41
Send Results .................................................................................................................................................... 42
CHAPTER 05. Quality Control
Control Test ...................................................................................................................................................... 44
How to Perform Quality Control .....................................................................................................................45
CHAPTER 06. Calibration
Calibration Set Test ..........................................................................................................................................48
How to Use the Calibration Set Test ................................................................................................................49
CHAPTER 07. Cleaning and Maintenance
Cleaning the Analyzer ..................................................................................................................................... 52
Maintenance and Transportation ...................................................................................................................52
4
CHAPTER 08. Screen Messages and Troubleshooting
Warning Messages ..........................................................................................................................................53
Error Messages ................................................................................................................................................ 55
ANNEX 01. Information for Healthcare Professionals
Protection against Infections ......................................................................................................................... 58
ANNEX 02. Reference
Warranty .........................................................................................................................................................59
Return .............................................................................................................................................................59
Disposal ........................................................................................................................................................... 59
5
CHAPTER 01. General Information
Main Menu Structure
Main
Standard Test Read Only Review
Login Login
Insert Device Insert Device
Device Check Device Check
Apply Sample Select All
Sample Check Delete
Analyze Delete All
Finish
Analyze
Finish
Patient
Results
6
Search
Select
Q.C
Result
Calibration
Results
Detailed
Results
Send
Results
Q.C Calibration Supervisor
Login Login Password
Insert Device Insert Device
Device Check Eject Device
Apply Sample
Sample Check
Analyze
Finish
Insert Device
Eject Device
Insert Device
Analyze
Finish
Manage
Operator
Setting
Load/
Save
Update
Info
7
Send Results
Manage Operator
Send Unsent Result
Send All Results
Send All Q.C Results
Send Last Results
Send All Patients Results
Send Selected Result
Load / Save
Settings Load Save
Operator ID Load Save
Save Test Records
Update Info
S/W Update View Version
Add
Edit
Delete
F/W Update View Network
8
Settings
Set Print Option
Set Timeout
Set Calibration and Q.C
General Settings
Instrument Name
Date/Time Language
Units
LIS
Parameters
Network
Volume/
Brightness
9
Symbols and Abbreviation
Symbols
These symbols and abbreviations may appear on the packaging, on the labels, and in the instructions for the BIONOTE
V200.
Symbol Description
Manufacturer
Consult instructions for use
Reference number
Date of manufacture
To indicate the date of analyzer manufacture
Serial number
Note
Indicates that the product is fragile and to handle it with care
Batch code :
Indicate the lot number for the analyzer
Indicates to discard it separately from other household waste
This product fullls the requirements of European Low Voltage Directive 2014/35/EU (Low Voltage
Directive, LVD), Electromagnetic Compatibility Directive 2014/30/EU (EMC Directive), RoHS Directive
2011/65/EU
Indicate that you should keep the product dry
Caution!
Indicate a situation, which if not avoided could result in damage to the analyzer or incorrect results
10
Abbreviation
Abbreviation Description
cCRP
fSAA
Comm
LIS
HIS
GUI
S/W
F/W
BN
Canine C-Reactive Protein
Feline Serum Amyloid A
Communication
Laboratory Information System
Hospital Information System
Graphic User Interface
Software
Firmware
BioNote, Inc.
11
Brief Precautions and Limitations
To reduce the risk of analyzer damage
Caution
Potential
Biohazard!
· Keep the BIONOTE V200 analyzer on a at and dry surface and avoid direct sunlight
when operating
· The analyzer has internal correction for normal levels of ambient light, but highly
intense light entering the analyzer may cause serious interference with the results
and thus must be avoided
· Never move the analyzer while a test is in progress
· Do not drop the analyzer as the unit could be damaged
· Do not attempt to disassemble the analyzer
· Do not immerse the analyzer in water or cleaning solutions
To reduce the risk of incorrect results
· The analyzer should be used by trained operators
· Do not use if the analyzer is displaying an error message that cannot be corrected
· To obtain accurate results, refer to the test device package insert for test storage and
system operating conditions
· Using test devices that are expired can cause the results to be inaccurate
To reduce the biohazard risk
· Dispose of used specimens in accordance with federal, state and local requirements
· Treat specimens as potentially biohazardous material
· Seek specic training or guidance if you are not experienced with specimen collection
and handling procedures
· Use of nitrile, latex, or other gloves is recommended when handling patient
specimens
12
CHAPTER 02. Introduction
Intended Use
The BIONOTE V200 analyzer is effective for measuring quantitative or qualitative biomarkers using body fluid in
the laboratory and point-of-care settings. The analyzer is indicated for monitoring and diagnoses using body uid
parameters in clinical settings by healthcare professionals. The analyzer should be used with the specied test device
produced by BioNote, Inc. Refer to the assay-specic package insert for details on specic tests.
Product Description
The BIONOTE V200 analyzer automatically recognizes the lot of the specic test devices in use by reading their 2D
barcodes. While the test device is inserted into the BIONOTE V200 analyzer, the application well of the test device is
illuminated by UV or RGB LED (light-emitting diode) with scanning. Before performing the measurement, the type
of the light reected determines the way the test device is analysed. When the specimen is applied, an enzymatic
reaction occurs forming a dye and the amount of formed dye is proportional to the concentration of the analyte.
The intensity of visual color or uorescence can be measured by illuminating with motor and LED, and detected by
reectance photometry. The measured value takes into account the signal strength of the light, measured a blank
value and information read including 2D barcode data. Finally, the test result is displayed on the screen and stored in
the memory of the analyzer simultaneously.
Before You Start Testing
Read and follow the instructions carefully in the user’s manual and the Instructions for use of the
test device and control. It is very important to follow the instructions to prevent incorrect results
Note
or improper treatment.
Specimens
The BIONOTE V200 analyzer should only be used with specic test devices for the analyzer. Because specimens are quite
dierent for each parameter, follow the instructions from each test device insert.
Safety information
There is a potential risk of infection. Healthcare professionals using the BIONOTE V200 analyzer to perform measurements
for more than one patient should use gloves and follow all other locally applicable health and safety regulations.
13
Operating conditions
To ensure proper function of the BIONOTE V200 analyzer, obser ve the following guidelines.
· Operate the analyzer only within the acceptable environmental conditions. Within the above range, the
acceptable temperature range varies depending on the reagent.
· To perform a measurement, place the analyzer on a at surface.
· Strong electromagnetic elds may impair the function of the analyzer. Do not use the analyzer close to sources
of strong electromagnetic radiation.
· The analyzer's air vents must be free for ventilation (D o not cover the air vents).
· If the analyzer experiences a sudden malfunction, unplug the adaptor from the outlet.
14
System Components
Unpack the shipping container and inspect the unit and components for damage.
Analyzer
Calibration Set
DC Power Supply
Display
Display Controls
Power Consumption
Over Voltage Category
Pollution Degree
Memory
RTC
Size
Labeling
Barcode Scanner (Optional)
· The AC/DC power adaptor is not supplied by BioNote, Inc. All users must use approved
Note
Adaptor. (VDE, UL, TUV and etc.)
· Do not connect to the power supply other than AC/DC adaptor specified rating in the
specication.
· The size of Jack which connects with DC power adaptor is 5.5 mm, 2.5 mm (External, Internal
diameter).
· Must check adaptor polarity when plugging the adaptor into the device.
BIONOTE V200 Analyzer
BIONOTE Vcheck Calibration Set
Input: AC100~240V, 50/60Hz
(Voltage tolerance ±10%)
Output: DC12V/5A
7" Color TFT LCD (800x480)
Graphical User Interface
Max 50W
Ⅱ
Ⅱ
3000
RTC Backup Battery Included
214.9 x 261 x 203 mm
User Manual
Barcode Scanner
15
Overview of BIONOTE V200 analyzer
A
B
C
D
E
F
G
H
I
J
K
16
A. Color TFT LCD
Use for displaying the test screen and interacting with the graphical user interface
B. Test Slot
Slot for inserting a test device into the analyzer
C. Test Device
Use for initiating the test by inserting the specied test device
D. Printer Cover
Use for covering and protecting the printer sheet
E. Printer Cover Button
Use for opening the printer cover
F. DC Jack Port
Use for connecting the power supply adaptor 12V/5A to its compartment
G. Power switch
Use for turning on/o the analyzer
H. USB x 4
Use for connecting the keyboard, barcode scanner and USB drive
I. LAN
Use for communicating through the local area network
J. Mini USB
Use for upgrading the F/W upgrade by connecting to a PC
K. Additional Device Port
Use for connecting to specic devices manufactured by BioNote, Inc.
17
Accessories of the BIONOTE V200 analyzer
Included Calibration set
Test device
Barcode scanner
(For patient ID recognition)
Optional
12V/5A AC/DC
power adaptor
CAL-1 CAL-2 CAL-3
Print paper
18
CHAPTER 03. Setting and Performance
Operating the Analyzer
STEP 1. Connect AC/DC adaptor jack
1-1. Place the analyzer on a bench top within reach of an electrical outlet. The unit is portable and
can be moved to a suitable location for testing. Ensure the bench top is stable, at and dry. Also
ensure the bench provides adequate space for the analyzer and barcode scanner stand.
1-2. Plug the DC power cord into the power port in the back of the analyzer. Plug the country specic
AC/DC adapter power cord into an available elec trical outlet.
1-3. Once the connection is complete, the analyzer is ready for use.
STEP 2. Setup the analyzer
2-1 When setting up the analyzer for the rst time, the operator's ID should be registered. The initial
supervisor password is 0000.
2-2 It is recommended to acknowledge the table presented on the supervisor menu.
Stage Menu Sub menu
1 Manage Operator Add / Edit / Delete
2 Load/Save Settings / Operator ID / Save test records
3 Update F/W update, S/W update
Print option Printed sheet 1/Printed sheet 2/Auto-printing
Time out Automatic turn-o time /Insert test device time
Calibration & Q.C Time period
4 Settings
General
Instrument name Instrument name/Facility name
5 Info View version / View net work
Date/Time/Language/Units/Network/LIS/Volume/ /
brightness
※
LIS/HIS can be set only when LIS/HIS server and
connection is ready.
19
1st step: Entering setup mode
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2016. 10. 26 l 16:19:03
1. First, touch the 'Supervisor' button on the screen in the main menu to enter setup mode and begin the test.
2. Input the password and press ‘OK’ for entry. The initial password is 0000. Press ‘Cancel’ if you want to return to the
previous setting.
2016. 10. 26 l 16:19:00
3. The supervisor menu the allows the operator to access additional functionality and security options depending
on the work environment and the location of the analyzer.
20
2nd step: Supervisor>Manage operator
2016. 10. 26 l 16:19:13
BIONOTE
2016. 10. 26 l 16:19:20
1. Select the ‘Manage Operator’ button on the screen to add, edit or delete the operator's ID. Press the ‘Back’ button
if you want to return to the previous setting.
2. To add the operator's ID, press 'Add'. Use the touch panel keyboard or a USB connected keyboard to add the
operator's ID.
3. After adding the operator's ID, it will be registered in the analyzer. Press ‘OK’ to conrm.
21
4. To edit the name of an operator currently registered in the analyzer, press ‘Edit’.
BIONOTE
2016. 10. 26 l 16:19:24
BIONOTE
2016. 10. 26 l 16:19:30
BIONOTE
2016. 10. 26 l 16:19:35
5. To delete the name of an operator currently registered in the analyzer, press ‘Delete’.
22
3rd step: Supervisor > Load/Save
2016. 10. 26 l 16:19:40
2016. 10. 26 l 16:19:45
The software including GUI can be updated by USB memory, and the rmware can be updated by
mini USB with PC connection. The USB can be connected at any time with the analyzer’s power on.
Note
1. To load or save the settings for the analyzer, enter the ‘Load/Save’ menu and press ‘Settings’ to proceed.
2. To load the appropriate analyzer data according to the test type, press ‘Load’. This can be done by inserting the
USB device containing data that can be loaded into the analyzer.
23
3.
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2016. 10. 26 l 16:19:54
2016. 10. 26 l 16:19:58
When the data is loaded, the screen will promptly show a message indicating that the data has loaded successfully.
Press ‘OK’ to conrm.
4.
To save analyzer settings that are cloned or duplicate settings from another device, press ‘Save’. When the data save
procedure is completed, press ‘OK’ to confirm.
5.
The operator can also load the saved operator's ID by pressing ‘Load’.
24
6. When the operator's ID is loaded, the screen will promptly show a message indicating that the operator's ID has
2016. 10. 26 l 16:20:00
2016. 10. 26 l 16:20:03
loaded successfully. Press ‘OK’ to conrm.
7. In addition, the operator can save the operator's ID by pressing ‘Save’. When operator's ID is saved, press ‘OK’ to
conrm.
The analyzer’s test results may be exported and saved to a USB drive. Saved data is to be managed
by the supervisor and all records of the test results can be displayed and printed.
Note
25
4th step: Supervisor > Update
1. To update the analyzer's software or firmware, enter the ‘Update’ menu after connecting the USB device
2016. 10. 26 l 16:20:08
2016. 10. 26 l 16:20:15
2016. 10. 26 l 16:20:18
containing the S/W or F/W update.
2. To update the new analyzer software, press ‘OK’. The analyzer will read the new software to be installed.
3.
To update the new analyzer rmware, press ‘OK’. The analyzer will read the new software to be installed.
26
5th: Supervisor > Settings
2016. 10. 26 l 16:20:25
1. To set the print option, automatic turn-o time, calibration and Q.C date, general settings or instrument name,
enter the ‘Settings’ menu. Press ‘Back’ to return to the previous menu.
2.
To set the number of printed sheets as 1, 2 or auto-printing mode (ON/OFF) enter the ‘Set Print Option’ menu.
Auto-printing means the built-in printer will automatically print all test results at the end of each test.
27
3. To control the analyzer's automatic turn-o time for power saving, enter the ‘Set Timeout’ menu. Insert test
device stage procedure means that the user doesn't require any action after inserting test device in to the
analyzer, and when the test is nished. Standby mode means the user doesn't require any action even when
inserting a test device into the analyzer.
4. To set the time period for calibration and Q.C, enter the ‘Set Calibration and Q.C’ menu. After the calibration and Q.C
procedure is completed, the analyzer will check the Q.C date and activate an alarm to indicate the number of days
since the last Q.C.
28
5. To set the date/time, language, test unit parameters, network, LIS parameters, sound volume, or LCD brightness, enter the
2016. 10. 26 l 16:18:57
2016. 10. 26 l 16:20:58
‘General Settings’ menu. Especially, under unit settings, test parameters corresponding to the test type can be set and the
parameters can be adjusted by updating the analyzer software.
<Setting the date/time>
<Setting the language>
29
<Setting the test parameter's unit>
Canine CRP
fSAA
㎎/L
㎍/㎖
192.168.33.100
192.168.33.1
192.168.33.200
5005
<Setting the network>
<Setting the LIS parameter>
Note
30
Consult a technician for the network settings information or the LIS parameters.
<Setting the sound volume/LCD brightness>
V200
<Setting the instrument name>
31
6th: Supervisor > Info
2016. 10. 26 l 16:22:30
2016. 10. 26 l 16:23:10
1. To display and view the analyzer's current software version, rmware or network, enter the ‘Info’ menu.
32
2. When ‘View Version’ is selected, the version information for the software and rmware will be displayed. Press ‘OK’
S/W Version : V1.00_R003.9(6)
F/W Version : 0.4
Serial NO. : FA20A02AA0027
192.168.33.100
192.168.33.1
5005
to conrm.
3. When ‘View Network’ is selected, information about the network will be displayed. Press ‘OK’ to conrm.
33
Performing a Measurement
2016. 11. 25 l 17:26:26
Check the following before performing a measurement:
· Is the analyzer connected to the AC/DC adaptor?
· Are date and time correct?
· Have you checked the analyzer settings?
Select the desired test mode
The Standard Test mode may be the most convenient for reading a single patient sample, as the user can perform a
Standard Test during the analysis period. The Read Only mode may be the most convenient for large volume testing
as the analyzer can quickly read multiple patient samples sequentially.
Standard Test mode
1. First, select the 'Standard Test' mode. Refer to the assay-specic package insert when collecting specimens for
the test and preparing the test procedure.
2. Input the operator's ID, patient ID, and order #. The operator's ID can also be input with the barcode scanner. If
the ID is not input into the analyzer, the analyzer will regard the operator as a guest user.
34
3. Once ‘Insert Device’ is displayed on the screen, insert the specied test device into the analyzer’s test slot. The
Canine CRP
analyzer automatically reads the information for the test device.
4. When inserting the test device into the analyzer, the analyzer will automatically check whether the device has
been used or not. The analyzer also reads the barcode data and conrms the test device is valid before starting
the test.
35
5. When the test device has been checked, apply the specimen to the sample well and press the ‘START’ button
Canine CRP
Canine CRP
04:58
Canine CRP
immediately. If the ‘START’ button is not pressed within 20 seconds after applying the specimen, the analyzer will
display an error message indicating that the test cannot be performed.
6. The analyzer automatically recognizes the test device. The time required for analysis depends on type of test
device.
7. The analyzer will automatically scan the test device and analyze the test results. The scanning time can var y with
the type of test device.
36
8. Once the analysis is nished, the test results will be displayed. The analyzer will print the test results if auto-
[ Canine CRP ]
Patient ID:
Date:
Operator ID:
Order #:
Canine CRP:
15.8 ㎎/L
2016/11/25 17:36:47
guest
Procedural Control: Valid
printing is enabled.
9. When the ‘OK’ button is pressed, 'Eject Device' will be displayed. The test device can then be removed from the
analyzer.
10. When the test device is ejected, the analyzer will move to another test log-in menu for the next test. Press ‘Cancel’
at any time to stop the test progress.
37
Read Only mode
2016. 11. 25 l 17:31:12
1. First, select Read Only’ mode. Refer to the assay specic package insert when collecting the specimen for the test
and preparing the test procedure.
2. Input operator's ID, patient ID, and order #. The operator's ID can also be input with the barcode scanner. If the ID
is not input into the analyzer, the analyzer will regard the operator as a guest user.
3. Prepare test device and label the test device accordingly.
· Add prepared specimen #1 to test device #1, then immediately set your timer to the designated processing
time as indicated in the assay-specic package insert.
· One minute later, add specimen #2 to test device #2.
· Continue adding the appropriate prepared specimen to the appropriate test device at an interval of one
minute.
· When the timer goes o for test device #1, insert test device #1 into the analyzer, the analyzer will display
the result in approximately ten seconds.
38
4. When inserting the test device into the analyzer, the analyzer will automatically check whether the test device
has been used previously or not. The analyzer also reads the barcode data and conrms the test device is valid
before starting the test.
39
5. The analyzer will automatically scan the test device and analyze the test results on the screen within 10 seconds.
[ Canine CRP ]
Canine CRP:
Patient ID:
Date:
Operator ID:
Order #:
Canine CRP:
15.8 ㎎/L
2016/11/25 17:36:47
guest
Procedural Control: Valid
6. When the `OK' button is pressed, 'Eject Device' will be displayed. The test device can then be removed from the
analyzer.
7. When the test device is ejected, the analyzer will move to another test log-in menu for the next test. Press
`Cancel' at any time to stop the test progress.
40
CHAPTER 04. Using the Analyzer Memory and Data Transfer
cCRP 2016-11-14 12:20:37
guest
Patient ID
guest
Order# Result
[ Canine CRP ]
Canine CRP: 15.8 mg/L
Patient ID:
Date:
Operator ID:
Order #:
Canine CRP:
15.8 ㎎/L
2016/11/25 17:36:47
guest
Procedural Control: Valid
Displaying Stored Measured Values
1. The BIONOTE V200 analyzer can store 3000 records together with date, time and ags, allowing the records to
be reviewed in order from the most recent to the oldest. When the memory is full and a new result is added, the
analyzer will delete the oldest record.
2. The Q.C details, calibration information, and patient results can be reviewed separately in the review menu. If
you select an entry, you can view the detailed results and send them to a PC or LIS/HIS server through a LAN
connection. You can also delete the records as well.
3. In any test results list, you may select a specic record. After selecting the desired record, you can view or print it
in detail.
41
Send Results
1. With several options available for sending the test results, you can choose the most appropriate method to
communicate with data server.
<Sending the unsent results>
<Sending the last result>
42
<Sending all results>
<Sending selected results>
43
CHAPTER 05. Quality Control
Control Test
It is important to perform control tests with more than one level of control to assure your system is working properly
and your testing technique is adequate.
When to use the control
· Before using the BIONOTE V200 analyzer for the rst time.
· To check the test device when you unpack a new device.
· If you drop the analyzer.
· Whenever your results are not in accordance with your expectations.
· If you have repeated a test, and the result is still lower or higher than expected.
· When you want to check the performance of the analyzer and test device.
Before using the control
· Check the expiration date on the control solution container. Do not use after the expiration or discard date
(date opened plus three months), whichever comes rst.
· Shake the container, discard the rst drop of the control solution, and wipe o the tip to ensure a proper
sample and an accurate result.
44
How to Perform Quality Control
Operator ID Control ID Control Order
1. To perform quality control according to the specific test type, refer to the assay-specific package insert when
preparing the test with the appropriate Q.C control solution for each type of test device. Enter the operator ID and CS
Info before starting.
The operator ID and CS Info can be entered into the analyzer with the touch panel or a USB
keyboard. This information can also be entered with the BN barcode reader, which is sold
separately.
Note
2.
Once ‘Insert Device' is displayed on the screen, insert the test device into the test slot.
45
3.
When the test device is inserted into the analyzer, the analyzer will automatically check whether the device is
unused or not. Also, the analyzer will read the barcode data and conrm the test device is valid before starting
the test.
4. When the procedure for checking the test device is completed, apply the control solution to the sample well of
the test device and press the 'START' button immediately.
5. The test device is processed in the analyzer.
46
6. The analyzer will automatically scan and analyze the test results.
7. Once the analysis is nished, the test results will be displayed. The analyzer will print the test results if autoprinting is enabled.
8. After the procedure of analyzing the test device is completed, 'Eject Device' will be displayed. The test device can
then be removed from the analyzer.
47
CHAPTER 06. Calibration
Calibration Set Test
The calibration set test is a required function that ensures optimal performance by checking the designated method.
When to use calibration set
· Whenever the analyzer is powered on
· When you drop the analyzer
· Whenever you do not agree with the results
· When you want to check the performance of an analyzer and test device
Precautions and warnings
· The calibration set test cannot be replaced with the control test
48
How to Use the Calibration Set Test
1
. To run the calibration set test, select the ‘Calibration’ menu. Enter the operator's ID before starting the calibration
set test.
The operator's ID can be entered into the analyzer with the touch panel or a USB keyboard. The ID
can also be entered with the BN barcode reader, which is sold separately.
Note
2. O nce 'Insert Device' is displayed on the screen, insert CAL-1 into the test slot. The analyzer will automatically read the
test device information.
49
3.
Calibration
Calibration
When the device is inserted into the analyzer, the analyzer will automatically check whether CAL-1 is unused
or not. Additionally, the analyzer will read the barcode data and conrm the device is valid before starting the
calibration set test.
4. The analyzer will automatically scan and analyze CAL-1. This will take approximately 15 seconds.
5. Next, insert CAL-2 for UV testing.
50
6.
Insert CAL-3 for RGB-LED testing. Ensure that CAL-2 and CAL-3 are inserted in order. Never change the order.
7.
If the measured value is within the normal range, ‘OK’ will be displayed on the screen.
8. If the measured value is not within the normal range, ‘EEE’ will be displayed on the screen.
51
CHAPTER 07. Cleaning and Maintenance
Cleaning the Analyzer
To prevent analyzer malfunction, keep the test slot free from blood, moisture or dust. Use lint-free cloth. For cleaning,
suitable solutions are mild suds, 70 % ethanol or isopropyl alcohol. For professional use (e.g.surgery), a mixture of
1-propanol, 2-propanol and glutaraldehyde is recommended.
Do not use an abrasive cloth or antiseptic solution, as these may damage the display screen.
Caution
Maintenance and Transportation
Each time the analyzer is turned on, it will automatically perform a self-test and will let you know if something is
wrong.
Note
Always switch o the analyzer before cleaning!
· Keep the test slot and internal part of the analyzer free from dust.
· The carrying case was designed to store a variety of supplies and to protect your
analyzer.
· For transportation, the analyzer should be stored at -20 to 50°C (-4 to122°F) and 10%
to 93% RH.
52
CHAPTER 08. Screen Messages and Troubleshooting
Warning Messages
Indication Warning description
Warning: Operator ID.
Pressed `OK' without entering the Operator ID.
Solution
Enter the operator's ID rst, then press ‘OK’.
Warning: USB not connected
USB device is not connected.
Solution
Conrm USB device is connected correctly.
Warning: Password
Entered incorrect supervisor password.
Solution
Enter valid password.
Warning: Update File Not Found.
The update le does not exist on the USB device.
Solution
Conrm that the update le is on the USB device.
After ensuring the update le is on the USB drive, connect the drive
and press `OK'.
Warning: Select Filename.
The settings le is not selected in the `Load Settings' menu.
Solution
Check the le name and select the correct le.
53
Indication Warning description
Warning: Review
No selection in the review data list.
Solution
Press ‘Send selected result’ after selecting the result.
Warning: Unregistered Operator ID
Entered operator ID is not registered.
Solution
Add operator ID in set mode.
Warning: Out of Paper
There is no printer paper in the analyzer.
Solution
Rell printer paper.
Warning: Incorrect IP address
Check IP address.
Solution
Conrm an IP address was entered.
Warning: Full memory
The maximum of 3000 records has been stored.
Solution
If the next test result is saved after this warning, the oldest result is
erased.
54
Error Messages
Indication Error description
E01: Test Device Error
The test device is damaged or inserted improperly.
Solution
Discard the test device and retest with a new test device and a new
specimen.
E02: Blood Specimen Error
An insucient amount of blood has been applied.
Solution
Retest with a new test device with enough blood, ensuring that the
sample is placed in the narrow channel at the top of the test device.
E03: Expired Test Device
The test devices are expired.
Solution
Retest with a new test device with a non-expired date.
55
Indication Error description
E04: Temperature Error Unknown Barcode
The environmental temperature is above or below the operating
range of the analyzer.
Solution
Move to an area in the acceptable temperature range for the
analyzer and perform the test. Do not heat or cool the analyzer
articially.
E05: Communication Error
Communication between the analyzer and barcode reader or
printer has failed.
Solution
Reconnect the analyzer and the external device. If the error
continues after turning the analyzer ON/OFF, please contact BioNote,
Inc.
E06: Total hemoglobin out of range
The measured total hemoglobin is outside the range of 7 to 23g/dL.
Solution
This error occurs with specimens known to have total hemoglobin in
the abnormal range. If the error continues after turning the analyzer
ON/OFF, please contact BioNote, Inc.
Result: Invalid
The test is invalid.
Solution
Retest with a new test device and a new specimen. If the error
continues after turning the analyzer ON/OFF, please contact BioNote,
Inc.
56
Indication Error description
E12: Calibration Overdue
The calibration is overdue.
Solution
If the error continues after turning the analyzer ON/OFF, please
contact BioNote, Inc.
E13: Unsupported Test Device
Loaded test device is not appropriate for the analyzer.
Solution
Check the type of test device and confirm it is manufactured by
BioNote
, Inc.
EEE: Internal Error Message for the Analyzer
An internal error has occurred.
Solution
If the error continues after turning the analyzer ON/OFF, please
contact BioNote, Inc.
57
ANNEX 01. Information for Healthcare Professionals
Protection against Infections
There is a potential risk of infection. Medical sta using the BIONOTE V200 analyzer to perform measurements for
more than one patient must be aware that any object coming into contact with the patient sample is a potential
source of infection.
• Use gloves.
• Apply sample outside the analyzer.
• Follow all other locally applicable guidelines and regulations on health and safety.
ANNEX 02. Reference
1. American Diabetes Association, Clinical Practice Recommendation Guidelines 2003, Diabetes care, Vol. 26.
Supplement 1. p.22
2. Stedman, TL. Stedman’s Medical Dictionary, 27th Edition, 1999, p. 2082.
3. Ellen T. Chen, James H. Nichols, Show-Hong Duh, Glen Hortin, MD: Diabetes Technology & Therapeutics,
Performance Evaluation of Blood Glucose Monitoring Devices, Oct 2003, Vol. 5, No. 5: 749 -768.
58
Warranty
You are a valued customer of BioNote, Inc. It is important to us that you are completely satised with the BIONOTE
V200 analyzer. BioNote, Inc. guarantees the analyzer will be free from defects in materials and workmanship for
a period of two years from the date of original purchase. If the analyzer does not work properly during this period
because of a defect in materials or workmanship, BioNote, Inc. agrees to replace or repair, free of charge, any and
all parts proven to be defective and subject to warranty. This warranty is in lieu of all other warranties, expressed or
implied, including any implied warranty of merchantability of tness for any purpose, other than stated herein. This
warranty does not apply to the performance of an analyzer that has been damaged by accident or has been altered,
misused, tampered with, or abused in any way. This warranty only applies to the original purchaser of the analyzer
and/or its agents.
Return
You must contact BioNote, Inc. before returning your analyzer and you will be instructed on how to do so. Analyzers
returned without authorization will not be accepted.
Disposal
The BIONOTE V200 analyzer must be disposed according to the local regulations concerning the disposal of electrical
and electronic equipment. The Waste Electrical and Electronic Equipment (WEEE) regulation implements the
provisions of the European Parliament and Council Directive 2002/96/EC aimed at reducing the amount of EEE waste
for nal disposal. Please contact our representatives in your area for the respective instructions before disposal.
59
V200
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