Finecare Fia Meter Plus1 fs113
Finecare Fia Meter Plus1 fs113
Finecare Fia Meter Plus1 fs113
Operation Manual
TABLE OF CONTENTS
Ⅰ Introduction 3
Ⅱ Contents 4
Ⅲ Specifications 7
Ⅴ Installation 9
Ⅵ Operation 13
Ⅶ Communication Settings 17
Ⅷ Quality Control 24
Ⅹ Trouble Shooting 26
Ⅺ Contact Information 27
Page 01
Ⅰ
Thank you for choosing Finecare™ FIA Meter Plus which is developed, designed, manufactured and
Read all contents of this Manual carefully prior to use.
sold by Guangzhou Wondfo Biotech Co., Ltd., Finecare™ FIA Meter Plus is a compact, portable
If the instrument is used in a manner not specified by the manufacturer, the protection provided by
fluorescent instrument used for quantitative determination of concentrations of various analytes in human
the instrument may be impaired.
blood or urine.
The following symbols are used on the Finecare™ FIA Meter Plus, related components and accessories,
Test Principle:
labels or in the text of this user manual:
Finecare™ FIA Meter Plus uses a LED as the excitation light source. The light from the LED hits a test
device that has been inserted in the meter. This causes the fluorescence dye in the test device to give off
energy. The more energy the fluorescent dye gives off, the stronger the signal.
Biohazard CE Marking After a buffer-mixed sample is added to the test device, the test device is inserted into the Finecare™
FIA Meter Plus. The meter measures the concentration of the analyte based on a pre-programmed
Caution Serial calibration process. Finecare™ FIA Meter Plus can only accept test devices that are designed
Number specifically for use with this instrument.
Consult Operator’s Manual
Intended Use:
Manufacturer
WEEE (Waste Electrical and The Test device and instrument are for in vitro diagnostic use only. Finecare™ FIA Meter Plus is
Electronic Equipment) intended for professional use.
Authorized Finecare™ FIA Meter Plus can be used in a laboratory of in a point-of-care setting.
Keep Dry
30℃ Representative Fragile,
10℃ Operate at 10℃~30℃
50℃ handle with care
-10℃ Store at -10℃~50℃
Current ON
Manufacturing Date
(Power)
Off (Power)
2 Power adapter (including the power cord) 1 Fig. 2.1 Finecare™ FIA Meter Plus- Front View
4 Ethernet cable 1
6 Operation manual 1
9 Packaging List 1
Power ON/OFF
Selector for
External Power operation mode
Interface
USB Interface Serial Port
Ethernet Interface
Page 04 Page 05
Ⅲ
Basic Specification
Page 06 Page 07
● The Finecare™ FIA Meter Plus must be used within the operating environment as specified in Section 1. Power on
Ⅲ. 1) Place Finecare™ FIA Meter Plus on a dry, clean, flat, horizontal surface, with the front surface at
● Operate the meter on a level, dry surface away from direct sunlight. least 10cm inside of the table edge.
● Use only the Power Adapter (including the power cord) provided with Finecare™ FIA Meter Plus. 2) Plug one end of the adapter into power outlet, plug the opposite end into the external power interface.
● The Quality Control card must be stored away sunlight and moisture when not in use. 3) Press the Power ON/OFF Switch.
● Do not write or place a label anywhere on the Quality control card, as it may interfere the meter
functionally.
● Do not move the meter while a test is in process.
● Ensure the sample fluids are fully absorbed before the test device is inserted in the meter in order to prevent
internal contamination of the meter.
● The test device tray shall be kept inside the main body of the meter all the time unless the user intends to
put a
test device or quality control card in it.
● The used Test device should be treated as potentially bio-hazard and should be disposed of according to the
standard procedures and relevant regulations.
● Gloves, goggles or other protective measures should be used when handling potential infectious materials.
● Do not insert anything other than a test device provided by the manufacturer into the test device Tray.
● Do not spill any liquid on Finecare™ FIA Meter Plus. Don’t immerse the meter into water or other
liquids. Power ON/OFF
● Do not drop or crash Finecare™ FIA Meter Plus.
Selector for operation mode
● Do not dismantle Finecare™ FIA Meter Plus without written authorization from Guangzhou External Power Interface
Wondfo Biotech Co., Ltd. or its representative.
● Do not place objects on Finecare™ FIA Meter Plus. This may damage the optical alignment in turn 2. Install Paper
result in compromised performance or mechanical damage. 1) Remove the printer cover by pulling up on the cover.
● The mains outlet for Finecare™ FIA Meter Plus shall be located in a user accessible position for 2) Tear or cut a clean, straight paper edge to feed paper roll into the printer.
easy unplugging in emergency. 3) Position the paper in a way that the paper will feed from under the roll, as opposed to over the top of the roll.
4) Insert the paper edge under the paper roller until it firmly seats or resistance is felt.
5) Place the paper roll into the paper compartment.
6) Replace the printer cover.
3. Main Interface
The user can operate the Finecare™ FIA Meter Plus by touching the LCD touchscreen by fingertip, or by
mouse and keyboard.
After switching on the meter, wait the meter to boot and show the main interface.
The test device tray will protrude automatically.
*Note:
If the meter cannot log in the initial interface successfully in three minutes, switch off the meter and restart.
If it still doesn’t work, please contact your sales distributor or Guangzhou Wondfo Biotech Co., Ltd.
Page 08 Page 09
The main interface is shown as below:
1) Click “Set Up”. The system information will be shown on the screen.
2) Input q1 in the "Authorization codes" field, click “Yes”.
3) Click “System Setting”.
4) The default setting of LIS connection is:
LIS IP address: 192.168.0.88
Port: 20035
To edit the LIS settings, type in new value in the corresponding box.
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To edit the existed test items:
1) Click “Edit”.
2) The test items are listed on the left of the interface. Click on the test item to be edited, its name will
appear on the ProName box. 1. Run a Test
3) Click on the Min box, delete the original value and type in the newly set value; Run a Test to analysis a test device.
4) Assign a new value to Max by following the same steps as 3); To start running a test:
5) Click “Save” to save the change, otherwise click “Quit”. 1) Insert ID chip into the ID chip port until resistance is felt.
It is recommended to insert the ID chip after successful booting.
To restore original settings: This step is necessary when a new lot of test device of specific test is applied on the meter for the first
1) Click “Reset”. time. Once the meter recognizes the Lot information of the chip, there is no need to read ID chip again
2) Click “OK” to confirm restoring original settings, otherwise choose “Cancel”. before running test, unless a new lot of test device is applied.
The ID chip can either be pulled out once the lot information is recognized or remain inserted.
2) Navigate to the main interface.
3) Click “Read ID Chip”. A message said “Warning: The ID chip ready” will prompt, click “Yes”. It
indicates that the ID chip can be recognized by the meter.
4) Choose test mode by click on “Quick Test” or “Standard Test”.
5) Choose Test mode.
It is assumed that before switching Test Mode, the selector switch for operating mode, which is on the
left side of analyzer, is on MAC.
Finecare™ FIA Meter Plus provides two test modes, the Standard Test mode and Quick Test mode.
Standard Test: Push the test device into the test device tray right after the specimen is fully absorbed.
The analyzer acts as an incubation place for reaction for a preset time duration. Wait until the analyzer
counts down to zero, the test result will be shown on the screen.
Quick Test: Push the test device into the test device tray after the reaction completes.
Device Parameters: 6) Input detailed patient information by clicking “Detailed information”..
To read the information about the following device parameters, click ; If the user does not input a serial number for a record, the analyzer will automatically assign a serial
number for it.
AD magnification times: Magnificating times of fluorescence signal. 7) Apply the test sample on the test device according to instructions of specific test.
Total length of the slot in running: The maximum distance running forward when motor starts with 8) Start the test.
photoelectric switch. Quick Test: Gently push the test device that is completely reacted into the test device Tray. Click .
Barcode recognition deadline: The timeout period of barcode recognition. Click “StartTest”.
Sampling starting point: The starting position of fluorescence data collection. Standard Test: Gently push the test device into the test device tray immediately after the specimen is fully
absorbed. Click . Click “StartTest”.
9) The meter will analyze the test device whilst the blue bar runs.
*Note:
These information are readonly to users. If you choose
“Write”, a message said “Warning: Please enter
password” will pop out, as users are not authorized to
edit these parameters.
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Page 13
10) After the blue bar stops running, the test result will be shown on the screen. The test device tray will 2.3 Delete History Data
protrude after the test completes. If not, click“Out”. 1) Select records by ticking the box in front of the record. The selected records are to be deleted.
2) Click “Delete”.
3) Choose “Yes” to delete the selected records, otherwise click “No” to quit.
Test Result:
2. History Data
The “History” function allows the user to view, to search, to delete or to export history data.
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3. Get a Count
The “Account ” function allows the user to get a count of the number of records in a query.
1) Click “Account” on the top of the main interface.
2) The user can choose “Test Account” or “Workload Account”. This section provides operational instructions on connecting Finecare™ FIA Meter Plus to LIS and PC.
Connecting the meter to LIS or a PC allows (1) test results to be sent to LIS or a PC immediatedly after
Testing Account: the test completes; (2) history data stored in the meter to be sent to the LIS or a PC.
Choose “Account by item”, select the type of test item from a list of all test items, OR
Choose “Account by sample”, select the type of sample type (urine, plasma, whole blood, etc) from the Transfer Protocol Instruction
list.
Finecare™ FIA Meter Plus sends data to outside by UDP, click “LIS” when the test is completed every
Workload Account: time, the current test data will be sent out.
Check in the box prior to “Submitting Doctor”, choose the name of the Doctor from the list on the The default connection setting is:
right; OR Finecare™ FIA Meter Plus IP address : 192.168.0.3
Check in the box prior to “Inspecting Doctor”, choose the name of the Inspecting Doctor from the list Finecare™ FIA Meter Plus Subnet mask: 255.255.255.0
on the right. Finecare™ FIA Meter Plus Gateway : 192.168.0.1
Receiving IP of PC: 192.168.0.88
Subnet mask of PC: 255.255.255.0
Default gateway of PC: 192.168.0.1
PC port: 20035
Communication mode: UDP
1) Insert one end of a network cable into the Ethernet port of Finecare™ FIA Meter Plus and the other
3) Apply a time filter to the records by clicking and and input dates. end into the PC 's Ethernet port.
4) Click .
Ethernet Port
Ethernet Port
Network cable
Fig. 6.1
Page 16 Page 17
2) Set IP address of the PC.
⑴ Click “Start” -> “Routine”-> “Attachment”-> “Communication”-> “Network”; double click “local Router, Switchboard
connection” and enter “Local Area Connection Status”.( See Fig. 6.2)
⑵ Click “Properties” to enter “Local Area Connection Properties” (See Fig. 6.3).
⑶ Double click “Internet Protocol Version 4 (TCP/IPv4)” to set up “Internet Protocol (TCP/IP) Ethernet Port Ethernet Port1:IP1
Properties”. Set IP address as 192.168.0.88,click “OK” (See Fig. 6.4).
Network cable
Ethernet Port1:IP2
Ethernet Port
Network cable
Fig. 6.5
Router, Switchboard
Fig. 6.4
Fig. 6.6
Page 18 Page 19
1) Start the PC. Click “Start” -> “Routine”-> “Attachment”-> “Communication”-> “Network”; right-click (5) Enter gateway address in the “TCP/IP Gateway Address” window, click “Add” (See Fig. 6.11).
“local connection”, choose “Properties” and enter to “Local Area Connection Properties”, double click (6) Return to “Advanced TCP/IP settings” and click OK (See Fig. 6.12).
“Internet Protocol Version 4 (TCP/IPv4)” . Choose “Use the following IP address” in the “Internet
Protocol Version 4 (TCP/IPv4) Properties” window.
Don’t change primary IP address of PC. Example:Primary IP address:192.168.1.6.
(1) Cick “Advanced”,enter to “Advanced TCP/IP settings” (See Fig. 6.7).
(2) To add new IP address, click “Add” as indicated in Fig. 6.8.
(3) Enter the following information in the “TCP/IP address” window. Click “Add” (See Fig. 6.9).
IP address:192.168.0.88,Subnet mask:255.255.255.0
(4) Return “Advanced TCP/IP settings”, add gateway by clicking “Add…” as indicated in Fig. 6.10.
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2) Set up the connection settings in Finecare™ FIA Meter Plus. 3) Open LIS data receiving software installed in the computer, select "network port". Click “Start”
(1) Navigate to the main interface of the meter, click “Setup”. Choose "System Settings". See Fig. 6.14. (See Fig. 6.18).
(2) Click , Choose “Ethernet configuration” from the menu (See Fig. 6.15). Note: Choose UDP as communication networks. Don’t choose “SerialPort”.
4) After the meter finishes testing, the test results will be sent automatically to the PC data receiving
software. If the user didn’t input detailed information, such as name and sample types, on the Finecare
™ FIA Meter plus, they will be left blank on the computer terminal (See Fig. 6.19). OR:
(3) Tick in the box as indicated in Fig. 15 to turn on Ethernet”. Input IP address of the meter in a pop-
out window. (See Fig. 6.16) Fig. 6.18 Fig. 6.19
(4) Set up the network port IP address of instrument for LIS transmission and ensure consistency
with IP address of the computer terminal (See Fig. 6.17).
5) Upload selected history data to PC by clicking ‘LIS’. (See Fig. 6.20 and Fig. 6.21)
Page 22 Page 23
The Finecare™ FIA Meter Plus has a built-in quality control which aims to monitor the internal system Maintenance
performance of the meter. . Besides regular cleaning or replacing print paper roll when needed, Finecare™ FIA Meter Plus needs
The quality control should be run on and initial use and each day of patient testing. minimal maintenance. The instrument shall be plugged out prior to cleaning.
To run the Quality Control:
1) Navigate to the main interface, click “QC”. The test device tray will protrude. If the tray does not Cleaning
protrude automatically, click “out”. Use a damp cloth with 0.5% bleach, 70% isopropyl alcohol or 70% ethanol to clean the external surface
2) Gently insert the quality control Card into the test device tray, push the tray inside the meter until of the instrument. Strong bleach (bleach concentration over 0.5%), oxidizing substances or solvents can
resistance is felt. cause permanent damage to the screen and other external surface material thus are prohibited to be
3) Click “Start”. applied to the meter.
If the meter has been used in clinical setting and needs to be repackaged, replaced or transported, it must
be cleaned. Use disinfectant (e.g. bleach concentration lower than 0.1%) and a cloth to wipe external
surface of the instrument thoroughly. Spray-washing or clean any internal parts and inner surface with
disinfectant are prohibited as liquid may seep inside the meter.
Return
Should a malfunction occur, please contact Guangzhou Wondfo Biotech Co., Ltd. or the local distributor.
If it were determined that the meter should be returned, a return authorization number will be assigned
and a replacement meter will be sent to you by Guangzhou Wondfo Biotech Co., Ltd.. The return
authorization number is printed on the packaging of the replacement meter. The user is expected to utilize
4) Wait until the blue progress bar runs to the end. The result of Quality Control will be displayed as below. the packaging of the replacement meter to return the malfunctioning meter. Please send the meter back to
If the result of quality control is not shown as below, contact the distributor or Guangzhou Wondfo and Guangzhou Wondfo Biotech Co., Ltd. as soon as possible following the receipt of the replacement meter.
report the problem
Transportation and storage
The original shipping container should be used to transport Finecare™ FIA Meter Plus or to store it
when it has not been in use over an extended period. Keep the Finecare™ FIA Meter Plus, dry in
upright position and in avoidance from sun, mechanical shocks, during transportation and storage.
Disposal
Any used test device should be disposed according to local ordinances regarding the disposal of bio-
hazardous materials.
The Finecare™ FIA Meter Plus, accessories and the packaging have to be disposed of waste correctly at
the end of usage. Please follow Local Ordinances or Regulations for disposal.
5) Click “Reset the slot”,to draw back the test device tray.
6) Click “Print” to make a printed copy of the quality control result if needed.
Page 24 Page 25
Ⅺ
Guangzhou Wondfo Biotech Co., Ltd. ’s expressed and implied warranties are conditioned upon full
Problem Probable Cause Remedy observance of manufacturer’s published direction with respect to the use of Guangzhou Wondfo Biotech
Co., Ltd. ’s products. Under no circumstance whatsoever shall Guangzhou Wondfo Biotech Co., Ltd.
Power Failure Check the Power Plug.
be held liable for any indirect or consequential damages.
Poor Connection between the Pull out the Cord and
Finecare™ FIA Meter Plus For technical assistance, call or send e-mail to us:
Power Adapter and the Cord. Re-connect firmly.
will not operate
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