WONDFO Finecare FIA Meter Plus User manual

Finecare™ FIA Meter Plus(Model No.: FS-113)
Version: 10/03/2016 Guangzhou Wondfo Biotech Co., Ltd.
FinecareTM FIA Meter Plus
Operation Manual
Model No.: FS-113

Finecare™ FIA Meter Plus(Model No.: FS-113)
Version: 10/03/2016 Guangzhou Wondfo Biotech Co., Ltd.
- 1 -
TABLE OF CONTENTS
Section
Content
Page
Ⅰ
Introduction and Principle
4
Ⅱ
Composition of System
5
Ⅲ
Specifications and Operation Conditions
8
Ⅳ
Initial Installation Procedure
9
Ⅴ
Operation Instruction
10
Ⅵ
Instruction for connection with LIS system and PC
21
Ⅶ
Quality Control
31
Ⅷ
Warning, Precautions and Limitations
33
Ⅸ
Service, Maintenance and Disposal
35
Ⅹ
Trouble Shooting
37
Ⅺ
Contact Information
38

Finecare™ FIA Meter Plus(Model No.: FS-113)
Version: 10/03/2016 Guangzhou Wondfo Biotech Co., Ltd.
- 2 -
Index of Symbols
Read all contents of this Manual carefully prior to use.
If the instrument is used in a manner not specified by the manufacturer, the protection provided by the
instrument may be impaired.
The following symbols are used on the Finecare™ FIA Meter Plus, related components and
accessories, labels or in the text of this user manual:
Biohazard
Caution
Consult Operator’s Manual
WEEE (Waste Electrical and Electronic Equipment)
Keep Dry
Operation Temperature Limitation
Storage and Transportation Temperature Limitation
Keep away from Sunlight
For in vitro Diagnostic Use only
Manufacturing Date
Serial Number

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Manufacturer
Authorized Representative
Direct current
ON (Power)
○
Off (Power)

Finecare™ FIA Meter Plus(Model No.: FS-113)
Version: 10/03/2016 Guangzhou Wondfo Biotech Co., Ltd.
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This manual contains the instructions for the operation of the Finecare™ FIA Meter Plus and for the
sample testing procedures. For specific tests’procedure please refer to the Instruction for Use of specific
products.
Finecare™ FIA Meter Plus manufactured by Guangzhou Wondfo Biotech Co., Ltd., is a portable
instrument for fluorescence detection to quantify concentration of various kind of analytes in human
blood or urine. The Test Device and instrument are for in vitro diagnostic use only. Finecare™ FIA
Meter Plus is intended for professional use.
Finecare™ FIA Meter Plus uses an LED as the Excitation Light Source. The emitted light from the
fluorescence dye is collected and converted into an electrical signal. The signals are closely related to
the amount of fluoresceing dye molecules present on the spot under examination.
After a buffer-mixed sample is applied to the Test Device, the Test Device is inserted into Finecare™
FIA Meter Plus and the concentration of the analyte is calculated by a pre-programmed calibration
process. Finecare™ FIA Meter Plus can only accept Test Devices that are designed specifically for use
with this instrument.
Finecare™ FIA Meter Plus is equipped with a built-in Test Device Holder and does not require an
external holder to place the Test Device in. The Test Device Holder will appear through the opening on
the front surface of the instrument.
The Power ON/OFF Switch, located on the left of the instrument, which powers the Finecare™ FIA
Meter Plus. The instrument has a built-in printer.
Figure 1 Working Principle
Section Ⅰ Introduction and Principle

Finecare™ FIA Meter Plus(Model No.: FS-113)
Version: 10/03/2016 Guangzhou Wondfo Biotech Co., Ltd.
- 5 -
Unpacking
After opening the package box, compare the contents with the list below.
If any item is missing, please contact your sales distributor or Guangzhou Wondfo Biotech Co., Ltd.
Detailed contact information is mentioned in Section ⅩⅠ .
Contents
1. Standard contents:
No.
Name
Quantity
1
Finecare™ FIA Meter Plus
1
2
Power adapter for instrument (including the power
cord)
1
3
Quality Control Card
1
4
Ethernet cable
1
5
Printer paper (roll)
1
6
Operation manual
1
7
Quick operation instruction for use
1
8
Warranty Card
1
9
Packing List
1
Section Ⅱ Composition of System

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Fig. 2.1 Structure Chart of Finecare™ FIA Meter Plus- Front View
Fig. 2.2 Finecare™ FIA Meter Plus Features - Left View
Power switch, Ethernet Port, USB Interface, Serial Interface, Power interface, Selector switch for
operating mode, which are used in Finecare™ FIA Meter Plus’s startup, shutdown, select the operating
mode and connection with PC and Ethernet.
Touch Screen
Printer
Test Device Holder
ID Chip Port
Power and Communication
interface
External Power Interface
USB Interface
Selector for operation
mode: select operation
shipped in instrument
or PC mode.
Ethernet Interface
Power ON/OFF
Serial Port

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Fig. 2.3 PowerAdapter
Consumables of Reagent Kit
Fig. 2.4 Test Device Features
(Remark: You shall buy the Test Devices separately)
Fig. 2.5 Test Device ID Chip
(The ID Chip contains the information of test item and lot number)
Fig. 2.6 Quality Control Card
Note: This accessory is Test regent’s consumable
Note: This accessory is Test regent’s consumable
(B)
(A)

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1. Basic Specification
Model No.
FS-113
Excitation light source
LED
Excitation spectrum
Center wavelength λ0= 470nm
Absorption spectrum
Center wavelength λ1= 525nm
Test Specimen
Whole blood, serum / plasma and urine
Software system
English and Chinese input method, customized intelligent
management module
Interface
RS232, USB, Ethernet network
Built-in Printer
Thermal
Size
270*238*146mm
Weight
About 2800g
Operating Environment
Temperature
10℃~30℃（50℉－86℉）
Relative Humidity
10%~80%
Atmospheric pressure
86kPa~106kPa
Power
Supply
Adapter
Input: 100-240Vac, 50-60Hz, 1.4-0.7A
Output: 12V 5.0A 60W MAX
Power Input:
12V ，45W
Location
Dry, clean, flat, horizontal surface away from direct sunlight,
mechanical vibration, and strong electromagnetic interferences.
Storage and Transportation Environment
Temperature
-10℃~+50℃
Relative Humidity
≤85%
Performance
Repeatability
CV ≤15%
Stability
CV ≤8%
Section Ⅲ Specifications and Operation Conditions

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1. Power Requirements
If you are uncertain of your power line, consult with your utility manager. The FinecareTM FIA Meter
Plus can only be used with the power adapter (including the power cord) provided. If the replacement
for Power Adaptor is required, please consult with your sales distributor or Guangzhou Wondfo Biotech
Co., Ltd.
2. Installation
Please be noted that Finecare™ FIAMeter Plus should only be used in 10℃～30℃(The operational
temperature of Test Devices should refer to relevant Instruction for Use) and Relative Humidity of
10%～80% conditions (Detailed information is mentioned in Section Ⅲ ).
①.Place Finecare™ FIA Meter Plus on a dry, clean, flat, horizontal surface, with the front surface at
least 10 cm inside of the table edge.
②.Connect the Power Cord with Finecare™ FIA Meter Plus to the wall power outlet.
Note: The meter shall be connected to a mains socket outlet with a protective earthing connection.
The mains outlet shall be located in a user accessible position for easy unplugging in emergency.
The mains plug of the power cord set is a disconnect device of the instrument. In order to completely
disconnect the instrument from the supply mains, the mains plug of the power cord set should be
unplugged from the mains outlet.
③.Turn on the Power ON/OFF Switch on the left of Finecare™ FIA Meter Plus to carry out power
startup and shutdown.( See Fig. 4. 1) Fig. 4.1
*Caution:
Keep the power cord for the Power Adapter in suitable place. Power cord without good maintenance
could render hazardous to connect/disconnect the Power Adapter.
Section Ⅳ Initial Installation Procedure
Power ON/OFF
External Power Interface
Selector for operation mode