FS-114

Construction and Maintenance Manual

 Content
1 Overall introduction of the instrument ........................................................................................................................... 3
1.1 Introduction of the whole instrument ................................................................................................................... 3
1.1.1 Basic parameters ........................................................................................................................................ 3
1.1.2 Standard configuration table ......................................................................................................................3
1.2 Introduction to the location of the hardware ........................................................................................................ 4
1.3 Transmission system ............................................................................................................................................. 5
1.4 The printing system ...............................................................................................................................................5
1.5 Introduction to the circuit board of the instrument ...............................................................................................6
1.5.1 Core board ..................................................................................................................................................6
1.5.2 Display screen supporting board ............................................................................................................... 6
1.5.3 Control board ............................................................................................................................................. 7
2 The introduction of the instrument software ................................................................................................................... 9
2.1 Testing interface and process ................................................................................................................................9
2.2 History .................................................................................................................................................................10
2.2.1 Interface overview ................................................................................................................................... 10
2.2.2 History-Edit ............................................................................................................................................. 10
2.2.3 History-Query .......................................................................................................................................... 12
2.2.4 History-CV ...............................................................................................................................................12
2.2.5 History-Waveform ................................................................................................................................... 13
2.3 Terminal .............................................................................................................................................................. 13
2.3.1 Terminal-User Setting ..............................................................................................................................14
2.3.2 Terminal-Print Setting ..............................................................................................................................14
2.3.3 Terminal-Statistics Setting-Testing Statistics .......................................................................................... 14
2.3.4 Terminal - Statistics Setting - Workload Statistics .................................................................................. 15
2.3.5 Terminal-Communication Setting ........................................................................................................... 15
2.3.6 Terminal - QC Setting ..............................................................................................................................17
2.4 System .................................................................................................................................................................19
2.4.1 System-QC ...............................................................................................................................................19
2.4.2 System - Setting ....................................................................................................................................... 19
2.4.3 System-Function ...................................................................................................................................... 23
2.4.4 System - Consumables .............................................................................................................................24
2.4.5 System - Advanced Setting ......................................................................................................................26
3 Installation process and maintenance ............................................................................................................................ 29
3.1 Installation part ................................................................................................................................................... 29
3.1.1 Installation preparation ............................................................................................................................ 29
3.1.2 Installation and debugging .......................................................................................................................30
3.1.3 Practical training ...................................................................................................................................... 30
3.2 Quality Control Part ............................................................................................................................................30
3.2.1 Introduction to Quality Control Products ................................................................................................30
3.2.2 Quality control products reconstitution and use ......................................................................................31
3.2.3 Quality control operation .........................................................................................................................32
3.3 Maintenance ........................................................................................................................................................32
3.3.1 Instrument quality inspection .................................................................................................................. 32
3.3.2 Port Check ................................................................................................................................................32
3.3.3 Printer .......................................................................................................................................................32
3.3.4 Shrapnel inspection ..................................................................................................................................32
4 Instrument fault maintenance ........................................................................................................................................ 33
4.1 Screen unit .......................................................................................................................................................... 33
4.1.1 Fault-touch screen problem (touch screen doesn’t work, no response, time goes on) ........................... 33
4.1.2 Fault-touch screen problem (the movement of the card slot and reading of the ID card is out of control)
...................................................................................................................................................................................33
4.1.3 Fault-blank screen occurs to the instrument ............................................................................................33
4.1.4 Fault-crash (keep the boot interface; the screen is stuck, and time stops) ..............................................33
4.1.5 Fault-The instrument results cannot be transmitted to the hospital lis system ....................................... 33
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 4.1.6 Fault-the interface temperature shows 0°C ............................................................................................. 34
4.1.6 Fault-abnormal heating ............................................................................................................................34
4.1.7 Fault-The system time is automatically restored to the factory setting .................................................. 34
4.1.8 Fault-automatic restart during the test, or cannot print, restart when start printing ............................... 34
4.2 The printer unit ................................................................................................................................................... 34
4.3 Drive system unit ................................................................................................................................................ 34
4.3.1 Fault-The card slot fails to reset, and the card slot protrudes abnormally ..............................................34
4.3.2 Fault-ID chip does not match the reagent batch ......................................................................................34
4.4 Tips ......................................................................................................................................................................35
4.4.1 Judgment skills of printer components ....................................................................................................35
4.4.2 Battery Installation ...................................................................................................................................36

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1 Overall introduction of the instrument

1.1 Introduction of the whole instrument

1.1.1 Basic parameters

Instrument parameters
Product Environmental requirements
FS-114
model Operating
10℃-30℃（50℉-86℉）
Screen 8-inch full touch temperature
Host weight 278mm*239mm*148mm Working
10%-80%
Host weight About 3.3kg humidity
Printer Built-in thermal printer Storage
-10℃-50℃
4 USB ports; 2 COM ports; one temperature
Interface Power supply AC220V,50Hz, input power 90W
Ethernet port
Software Main technical indicators
Linux system
system Coefficient of variation (CV, %)
Repeatability
≤10%
Stability Relative bias (A value) ≤±15%
Linear Linear correlation coefficient (r) ≥
correlation 0.990
Accuracy Correlation deviation (Bias)≤±10%

1.1.2 Standard configuration table

Sn. Description Qty. Unit

1 Host 1 Unit

2 Power adapter 1 Set

3 Quality inspection card 1 Piece

4 Cable 1 Piece

5 Printer paper 1 Roll

6 Instruction 1 Piece

7 Warranty card 2 Piece

8 Certificate 1 Piece

9 Packing list 1 Piece

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1.2 Introduction to the location of the hardware

FS-114 contains several parts, which are composed of printer components, screen components, control
components, transmission systems and batteries.

Screen

ID chip port Reagent

card slot

Fan
Printer

Light guide

Power switch

Operation mode selection

Power port USB port Ethernet Serial port switch: It is used to select the
port instrument's own operation or
computer connection mode
Figure 1-2-1 Appearance of the instrument

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1.3 Transmission system

The transmission system starts from the insertion direction of the reagent card, including four functional
modules of reagent card slot, light source detector, temperature control board and transmission motor. Each
module performs its own corresponding task to jointly facilitate the operation of the system. Let's take a
closer look at these modules and see where they fit in the overview.
The components location diagram is as follows:

Figure 1-3-1 System overview

1 Reagent card slot: The single-channel reagent card slot can only hold one card at a time. There are two
pieces of small shrapnel at the bottom of the card slot to support and fix the reagent card.

2 Light source collector: It includes red light, blue light, red light detection results, and blue light
detection reagent barcodes.

3 Temperature control board: It is installed on the side of the base to monitor the temperature of the light
source collector and the reagent card slot.

4 Transmission motor: It works for the insertion and popping up of the reagent card slot.

1.4 The printing system

FS-114 works with a thermal printer with a specification of 57mm*50mm, which is provided with built-in
LED indicator light and reset button and it greatly facilitates us to detect whether there is a fault. Let's take a
look at the internal and external composition of the thermal printer.

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 Figure 1-4-1 Appearance of the printer Figure 1-4-2 Back of the printer

Figure 1-4-3 Front of the printer

1.5 Introduction to the circuit board of the instrument

1.5.1 Core board

Component location: It is inlaid on the screen supporting board of the upper shell panel.
Component function: As the upper computer, it executes the instructions from the operation display screen
and sends the instructions to the lower computer and stores the data.

1.5.2 Display screen supporting board

Component location: It is under the upper shell panel
Component function: As the lower computer, it realizes the screen display, connection to the main board,
printer module and data transmission.

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 Figure 1-5-1 Display screen supporting board (wiring diagram)

J1 Core board connection line J9 Printer power cord J7 Printer data cable
J10 Display FFC cable J4 Display screen data cable J14 Screen touch line
connection
J13 LED light

1.5.3 Control board

Component location: It is at the bottom of the instrument.
Component function: As the lower computer, it accepts the instructions sent by the core board to control the
operation of each module.
Wiring diagram: (with wiring instruction)

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Figure 1-5-2 Mainboard (actual location) Figure 1-5-3 Mainboard (wiring diagram)

Display screen Transmission

J1 Switch power supply J3 J5
supporting board cable motor control line
Temperature board
J6 J7 Heating cable J9 Control panel PT
connection
AD data
J10 Battery connection J11 LED wire J19
acquisition board
Card slot limit
J20 J21 FFC cable J22 ID chip card slot
position optocoupler
J23 Fan control wire

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2 The introduction of the instrument software

This chapter introduces the application of FS-114 software functions based on the software version (1.0.2.2).
There are slight changes in other versions, please refer to the actual version. The catalog frame runs through
the whole text with the first row of icons on the main interface as the main line. The functions of each
software application are described in detail.

2.1 Testing interface and process

Description:
1 "Quick Test" and "Standard Test" can be selected in the "Test Mode" option.
2 Screen is capacitive LCD screen, please touch it with your finger.
3 You can operate the instrument with menu structure, touch the required function button with your finger,
and the instrument enters the function directory. You can directly touch the desired button to switch the
screen to another function.
The instrument display screen is divided into 4 areas as shown in the figure

Figure 2-2-1 Interface overview

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1 The function button area It displays the icon buttons of each function interface of the system
2 The information editing area You can view and edit sample information and check the display result in
this area.
3 The test operation area It displays the corresponding button operation name
4 The system time area It displays the current date and time information of the system
Note:
1. Please note the selection status of the sample type and test mode and make sure to select the correct
settings before samples testing to reduce the loss of reagent cards and time wasted.
2. We also set the temperature monitoring function of the incubation area (transmission system) in the
upper left corner of the instrument to provide real-time temperature detection result. The exact
temperature is the guarantee of accurate measurement.

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2.2 History

2.2.1 Interface overview

The instrument will automatically store all measured data after each measurement. Users can edit, query,
select all, delete, export, print, LIS, CV and waveform through the contents introduced in this chapter. Tap
[History] to enter the history result interface, as shown in Figure 2-2-2.

Figure 2-2-2 History result interface

Note: Each page in the history interface can display the test data of 9 lines of samples. Each column can
display the items, results and other information of each sample, touch to select related items for printing or
lis transmission.
2.2.2 History-Edit
Note: In the factory mode, click [Edit] to display the selection box as shown in Figure 2-2-3. If you need to
edit the patient information, check [Patient Information Edit]; if you need to edit the patient result, check
[Patient Result Edit]. Since the result can only be changed at factory mode, the selection box only appears
in factory mode.
In the administrator mode, if you click [Edit], the [Patient Information Edit] interface will pop up directly,
and you can edit it directly, as shown in Figure 2-2-4.

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 Figure 2-2-3 History-Edit

Figure 2-2-4 History-Patient Information Editing

Note:
1. The real information of the patient shall be filled. The sample number here cannot be added by
scanning the code, but can only be changed manually.
2. The submitting department, submitting physician, inspector and reviewer can only be edited
manually.
3. The submission time and sampling time are all empty by default, which can be set according to the
needs of the end user. The time here is not the testing time or reporting time. The instrument only
displays the reporting time by default, and the examination time is (reporting time - the time
required for project examination).
Attachment:
Sampling time: sample collection time, non-inspection time;
Submitting time: sample delivery time, non-inspection time;
Inspection time: the time when the sample begins to be inspected;
Reporting time: the time when the sample inspection is completed and the result is obtained;
Printing time: the report printing time

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 Figure 2-2-5 History-Patient Result Edit

Note: Please use this feature with caution.

2.2.3 History-Query
Note: You can query the sample result according to the report time, sample type, sample number, patient
name, gender, age, serial number and other information.

Figure 2-2-6 History-Query

2.2.4 History-CV
Note: You can select multiple results to automatically calculate the CV value for the batch sample results.

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 Figure 2-2-7 History-CV

2.2.5 History-Waveform
After selecting the item and clicking the waveform, you can view the sample waveform. Take D-Dimer as
an example, as shown in Figure 2-2-8.

Figure 2-2-8 History-Waveform

2.3 Terminal

There are five settings, including user setting, printing setting, statistics setting, communication setting and
QC setting are available for users in the terminal function area.
User setting: It is used to set user accounts and passwords in the terminal functional area.
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Printing setting: It is used to make settings for printing.
Statistics setting: It is divided into testing statistics and workload statistics for easy laboratory statistics.
Communication setting: It includes WIFI settings, Bluetooth settings, network settings and local settings.
QC setting: It includes including QC data, QC setting, QC reports and L-J plots.
2.3.1 Terminal-User Setting
You can add, edit and delete accounts in this interface.

Figure 2-3-1 Terminal-User Setting

2.3.2 Terminal-Print Setting

The type of printer, such as thermal printer, HP1108, HP1010 or HP1020can be selected in the printing
setting.
If you select an HP printer, the printing paper size of A4, A5, B4 and B5 are optional.
To set the template for printing the report, click "Custom Template", you can enter the setting and check the
target printing option.
Set the number of copies to print

Figure 2-3-2 Terminal-Print Setting

2.3.3 Terminal-Statistics Setting-Testing Statistics

In the test statistics, it can be divided into [Project Statistics] and [Sample Statistics]. The related interface is
shown in Figure 2-3-3.
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In the test statistics, the project and sample statistics are provided, the relevant data can be regularly
recorded and summarized, which then provide data reference for related work.

Figure 2-3-3 Terminal-Testing Statistics

2.3.4 Terminal - Statistics Setting - Workload Statistics

In the workload statistics, the submitting physician, the submitting department, and the inspector can search
for the sample workload statistics they have done within a certain period of time.
Please refer to the [Test Statistics] step for specific operations. The measured departments, doctors, and
sample sizes will be displayed in sequence on the right side of the interface.

Figure 2-3-4 Workload Statistics

2.3.5 Terminal-Communication Setting

The communication setting includes WIFI settings, Bluetooth settings, NB, network settings and local
settings.
WIFI setting and Bluetooth setting is available, you can connect the corresponding WIFI and Bluetooth.
Since the NB function has not been launched yet, we will not introduce it in this document.

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 Figure 2-3-5 Terminal - Communication Setting

1. Terminal - Communication Settings - Network Setting

In Terminal - Communication Settings - Network Settings, you can set the LIS's IP address, subnet mask,
default gateway, port number, connection protocol, etc., as shown in Figure 2-3-6.

Figure 2-3-6 Communication Settings-Network Settings

2. Terminal - Communication Settings - Local Setting

In the local settings, the IP address settings, subnet mask settings, default gateway settings, MAC address
settings, and serial port connection settings of the instrument can be set, as shown in Figure 2-3-8.

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 Figure 2-3-8 Communication Settings -Local Settings

2.3.6 Terminal - QC Setting

In the QC setting, you can view the quality control data, quality control reports and L-J diagrams and make
quality control settings.

Figure 2-3-9 Local Setting

1. QC data
In this interface, you can analyze, edit, query, output, upload LIS, delete, backup, and print the previous
quality control data. As shown in Figure 2-3-9.
2. QC settings
In this interface, you can add, edit, delete QC products, and set quality control rules.

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 Figure 2-3-10 QC Settings - QC Setting
3. QC report
In this interface, you can query the quality control of a certain period of time, and print the QC report.

Figure 2-3-11 QC Settings-QC Report

4. L-J diagram
In this interface, you can draw, edit and delete the quality control L-J diagram.

Figure 2-3-12 QC Setting-L-J Diagram

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2.4 System

In the "System" interface, there are several functional sections as following:

QC: Test (internal self-test of the instrument)
Settings: You can make more instrument function settings;
Function: You can set the instrument configuration function, view the log, and upgrade the instrument;
Consumables setting: You can view ID chip information, project parameter information and cutoff value;
Advanced setting: It is used for engineers to debug instruments and set more parameters.

Figure 2-4-1 System-QC

2.4.1 System-QC
Under this interface, you can perform the internal self-check operation of the instrument, including the light
source system, transmission system, and circuit system. After inserting the QC card, click "QC" in the lower
right corner to test, and the test result will be displayed behind the light source system, transmission system,
and circuit system respectively.
In the bottom row of buttons, you can control the reset and popping up of the card slot, add/edit and delete
quality control products, print the quality control results, and set the report template. As shown in Figure
2-4-1.

2.4.2 System - Setting

In factory mode, this interface includes SN code setting, language setting, time/date setting, mode setting,
power setting, screen setting and sample ID setting.
1. SN code setting
The SN code is the serial number of the instrument, which does not need to be changed after leaving the
factory, as shown in Figure 2-4-2.

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 Figure 2-4-2 System-Settings-SN Code

2. Language setting
This interface supports changing language among multiple languages. As shown in Figure 2-4-3.

Figure 2-4-3 System-Settings-Language

3. Time/Date Setting
This interface supports time setting and date setting, as well as display mode. As shown in Figure 2-4-4.

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 Figure 2-4-4 System-Settings-Time/Date
4. Mode setting
The instrument mode, including user mode, administrator mode, and factory mode can be switched in this
interface. The passwords for both the administrator and factory mode are: 123456. As shown in Figure
2-4-5.

Figure 2-4-5 System-Settings-Mode

5. Power Setting
This interface is used to set the sleep function of the instrument, as well as the automatic shutdown settings.
As shown in Figure 2-4-6.

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 Figure 2-4-6 System-Settings-Power Setting

6. Screen Setting
It is used to set screen brightness. As shown in Figure 2-4-7.

Figure 2-4-7 System-Settings-Screen Setting

7. Sample ID setting
This interface is used to set the length limit of the sample number.
Automatically fill "0" mechanism:

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 Figure 2-4-8 System-Settings-Sample ID Setting

2.4.3 System-Function
In this function module, you can set more configuration functions of the instrument, view the instrument
alarm log, and upgrade the instrument software.

Figure 2-4-9 System-Function-Configuration

1. Configuration:
Uploads LIS and not display the arrows: Select whether to display the arrows when uploading LIS.
CRP 30 uses ID 0: During uploading LIS, change the product code of No. 30 to No. 0 to upload. (Enabled
by default)
Display the lot NO.: Whether to display the lot number in the historical results.
Show qualitative value: Whether to display quantitative results.
Start TCP service: Do not open to end users.
Show linear range: Whether to judge the linear range.
Dynamic password: Whether to enable dynamic password.
Use IFCC and eAG: Whether to use IFCC and eAG for saccharification results.
Display CRP: The display form of the whole CRP.

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Data Import: Data import.
Data Export: Data export.
Export Log: Export log files.
Need active: Whether it needs to be activated at starting up.
2. Log:
The alarm information of the instrument can be viewed, exported or deleted. Figure 2-4-10.

Figure 2-4-10 System-Function-Log

3. Upgrade:
You can check the complete software version number, and upgrade the software of the instrument. For
specific upgrade steps, please contact the engineer. As shown in Figure 2-4-11.

Figure 2-4-11 System-Function-Upgrade

2.4.4 System - Consumables

In factory mode, you can view ID chip information, commodities fleeing prevention settings, view and
modify project parameters, and view cutoff parameters.
1. ID chip:
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In this interface, you can view the ID card information details, read and modify the ID card information
(please operate under the guidance of the engineer), and set the commodities fleeing prevention function ().

Figure 2-4-12 Consumables-ID Chip

2. Project parameters:
In this interface, you can view, add, edit, delete, calibrate parameters of each project and convert them.
Please operate under the guidance of engineers during operating parameter calibration and unit conversion.
As shown in following Figure 2-14-13.

Figure 2-4-13 Consumables-Item Param.

3. Cutoff parameters:
In this interface, you can view and edit the cutoff value of a batch of reagents. As shown in Figure 2-4-14.

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 Figure 2-4-14 Consumables-Cutoff Param.

2.4.5 System - Advanced Setting

In the advanced setting, the authorization password is: wondfo. After entering the setting interface, you can
perform the instrument single instruction test, barcode calibration, barcode parameter writing, dark current
test, and view the temperature curve. As shown in Figure 2-4-15.

Figure 2-4-15 System - Advanced Setting

1. Single instruction test

In the single-instruction test, the functions and instructions are described as follows:
Finecare Motor: It can perform reset, popping up of the slot motor and barcode reading test.
Finecare Devi. Param: Click the option box, you will find the reading and writing of AD magnification, the
reading and writing of the number of working steps of the card slot, what be read by barcode, the reading
and writing of sampling starting point, and the lower computer Version.
Slot Temp. SET: Slot temperature setting.
Write Temp. Value: Write temperature threshold.
Read the set value: Read the (temperature) set value.
Upgrade WIFI: Not open to customers.
Slot Temp.: Slot temperature (display value).
Env. Temp.: Ambient temperature (display value).
Battery Capacity: Battery capacity.
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Query Value: Query the "Battery Capacity" value.
NB-IOT Power: Not open to customers.
Heating: Start the heating function.
Red light: Turn on the red light.
Blue light: Turn on blue light.
Turn off the screen: Turn off the screen.
Reset Power: Power reset.
Laser Barcode & Ink barcode: Select the barcode reading method, Laser & Ink barcode.
Electric Fan: Whether to start the electric fan.
Fan Automatic control: Fan automatic control.
IIR Filter: Not open to customers.
Read Filter: Not open to customers.
Version: View the full version number.
As shown in Figure 2-4-16.

Figure 2-4-16 Single instruction test

2. Barcode Calibration
Insert the 5 red light bar code calibration cards provided by Wandfo Wondfo (as shown in Figure 2-4-17)
into the instrument in turn to calibrate the instrument with red light bar codes, as shown in Figure 2-4-18.
Operating procedures:
1. Insert the No. 1 card, click [18-bit black stripe calibration], and read the value.
2. Insert the No. 2 card, click [18-bit white stripe calibration], and read the value.
3. Insert the No. 3 card, click [22-bit black stripe calibration], and read the value.
4. Insert the No. 4 card, click [22-bit white stripe calibration], and read the value.
5. Insert the No. 5 card, click [Black Stripe Compensation], and read out the value.

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 Figure 2-4-17 Barcode Calibration Card Figure 2-4-18 Barcode Calibration

3. Barcode Parameters
You can read and write the barcode verification value in the barcode parameter interface. The 18-bit and
22-bit black/white barcode calibration values obtained from the above barcode calibration can be written
into the barcode parameters for calibration, as shown in Figure 2-4-19.

Figure 2-4-19 Barcode Parameters

4. Dark current test
Insert a reagent card and click "Dark Current Test", you will obtain a test curve. As shown in Figure 2-4-20.

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 Figure 2-4-20 Advanced-Func Test

5. Temperature curve
In this interface, you can view the temperature change curve of a certain day, as shown in Figure 2-4-21.

Figure 2-4-21 Advanced-Temp. Curve

3 Installation process and maintenance

3.1 Installation part

3.1.1 Installation preparation

[Communication information]
Hospital information: name, address, department, contact person, etc.
Dealer information: person in charge, installation time, whether to go together
Instrument information: instrument model, instrument arrival time, installation department
Reagent information: project, reagent arrival time
Report information: whether to connect to LIS (lis engineer is in place) to issue a report
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Logistics Information: Instrument/Reagent arrival time
Other information: whether the computer/printer, etc. are available
[On-site preparation]
1. Confirm to the director of the department whether the equipment department needs to carry out
unpacking inspection, and check the accessories after unpacking and check whether the reagents are
complete and in good condition;
2. Confirm to the director of the department for the installation location of the instrument, and remind the
teacher for the positioning precautions (leave space around and avoid direct sunlight, shock or
centrifuges, etc.)
3. Confirm to the director of the department that whether the power supply is three-phase power supply,
whether a grounding protection device is provided, turn on the power supply and turn it on to confirm
whether the reset is successful.
3.1.2 Installation and debugging
1. Consumables preparation: Unpack the installed reagents, check whether it is in good condition, and
read the ID card
2. Quality control preparation: If the quality control products are provided with the delivery, reconstitute
and wait for the test. If the quality control products are not available, conduct the testing with a
standard fluorescent color card to check if the test results are close to the target value.
3.1.3 Practical training
1. Confirm to the director about the start time of the training, and ask the host to gather the teachers in
front of the instrument to introduce themselves and do not block the instrument.
2. Train all operation teachers in a simple manner, use trial equipment to demonstrate operations and let
all operation teachers conduct field practice, observe whether their operations are correct, and answer
questions raised by them. And the common problems shall be further emphasized.
3. Communicate to the chief teacher in charge of the instrument to clarify the operation precautions and
common problems, and add WeChat account to each other to facilitate communication.
4. Fill in the installation and commissioning acceptance form and ask the director to sign it (required
information: user name, installation department, instrument name, model and code, installation time,
training reagent items, supplier, installation engineer, director's signature and phone number)
5. Insert the contact information of the engineer into the instrument running indicator and paste it on the
right side of the instrument for easy search. Enter the CRM system to enter the installation information.

3.2 Quality Control Part

3.2.1 Introduction to Quality Control Products

[Product Specification] Freeze-dried powder type, level 1: 0.5ml×1; level 2: 0.5ml×1; level 3: 0.5ml×1;
[Intended use] It is suitable for monitoring and evaluating the precision of the test results of the test kits
produced by Guangzhou Wondfo Biotech Co., Ltd.
[Test principle] The recombinant antigen contained in the quality control product can react with the specific
antibody in the detection reagent to form a complex, and the quantitative test result of the quality control
product can be judged by detecting the content of the complex.
[Components] The quality control product package consists of quality control products (including level 1,
level 2 and level 3) and instruction. The quality control product is lyophilized powder, and its main
components are recombinant antigen, calf serum, glycine, Sodium Azide.
[Storage condition] 2℃-8℃ sealed and protected from light [Validity period] Valid for 24 months.
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[Applicable instruments] Immunofluorescence detector produced by Guangzhou Wondfo Biotech Co., Ltd.
Due to the limitation of the test method, this product is not a calibrator and cannot be used for instrument
calibration

Figure 3-2-1 Quality control products

3.2.2 Quality control products reconstitution and use

[Reconstitution] Take the quality control product out of the refrigerator, equilibrate at room temperature for
30 minutes, add 0.5ml of distilled water dropwise, and shake well until there is no powder to complete the
reconstitution.
Note: Distilled water standard: distilled water for injection or purified water prepared by a water maker. The
water maker can be shared with the biochemical instrument. If the water maker is not available, you can buy
normal-temperature Watsons distilled water and C’estbon purified water and purified water of other brands
are not recommended.
[Use] It is shall be treated as the patient's [serum] specimen during the test. For the operation steps, please
refer to the instruction of the detection reagents and immunofluorescence detector produced by Guangzhou
Wondfo Biotech Co., Ltd.

Figure 3-2-2 Reconstitution and use of quality control products

[Precautions]
1. The quality control product shall be used within 8 hours at room temperature after opening and
reconstitution.
2. Accuracy: Test the quality control product on the calibrated test system, and the test value shall be
within the established target value range.
3. The water for reconstitution of the lyophilized quality control product shall be equilibrated to room
temperature beforehand, and the amount of water added during reconstitution shall be accurate.
4. Strictly operate in accordance with the instruction, control the detection room temperature, the amount
of sample added, the mixing time and the testing time, etc.
5. If the expected value cannot be obtained, please first rule out whether the test card is expired or the
result deviation caused by improper operation. If the above factors are ruled out, please replace the
quality control product with a new one and test again.
6. If there are lumps or floccules after reconstitution, which may be caused by overheating or freezing.
Discard the spoiled product and replace it with a new set of quality control products.
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7. This product does not contain animal-derived substances other than human or calf serum (inactivated),
and is free of potentially infectious.
8. The expired quality control products shall not be used and or used as calibrators.
3.2.3 Quality control operation
1. Quality control test
1 Switch the instrument test mode to standard test
2 Read the ID chip
3 Add the prepared quality control product to the test card according to the sample volume of the QC
project and insert it into the instrument
2. Fill in the quality control report
After completing the quality control, do fill in the quality control form in duplicate, one for the hospital to
keep for the superior inspection, and the other for the office to keep the file. If the copy for hospital needs to
be stamped with the official seal, please fill in the electronic version of the quality control form, and send it
to the call center, and the staff there will print it out, stamp and send it back to the area.
3. Analysis of abnormal test results
1 Check the validity period of the quality control product and whether there is any abnormality during the
preparation, and whether the quality control product is sufficiently rewarmed
2 Check whether the reagent card is inserted properly
3 Check whether there is any deviation in the light source scanning
If the instrument is normal after checking, please replace the reagent batch for quality control

3.3 Maintenance

3.3.1 Instrument quality inspection

Click [Quality Inspection] - Insert Quality Inspection Card - Click [Start Quality Inspection], and repeat the
inspection of 'Optical System', 'Power Transmission System', and 'Circuit System' twice.

3.3.2 Port Check

Check the status of the network port by turning the light on and off. If the network cable is inserted
normally, the green light is always on; and the green light flashes during the transmitting of data.

3.3.3 Printer
During use, the rollers inside the printer are easily stained with dust, which shall be cleaned regularly.

3.3.4 Shrapnel inspection

The single-channel FS-114 is provided with a card slot and two pieces of shrapnel. If the shrapnel is loose,
it will affect the test results. Therefore, it is necessary to check the firmness of the shrapnel and tighten the
screws on it if necessary.

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4 Instrument fault maintenance

4.1 Screen unit

4.1.1 Fault-touch screen problem (touch screen doesn’t work, no response, time goes
on)
Cause of failure: Solution:
1. Switch the switch to the "PC" side 1. Switch the switch back to the "MAC side"
2. The screen control line is in poor contact 2. Check the screen control line and re-plug
3. The FFC cable is in poor contact 3. Check the FFC cable and re-plug
4. The screen supporting board is broken 4. Replace the screen supporting board
4.1.2 Fault-touch screen problem (the movement of the card slot and reading of the ID
card is out of control)
Cause of failure: Solution:
1. Switch the switch to the "PC" side 1. Switch the switch back to the "MAC side"
2. The FFC cable is in poor contact 2. Check the FFC cable and re-plug

4.1.3 Fault-blank screen occurs to the instrument

Cause of failure: Solution:
1. The display power cable J4 is in poor 1. Check the screen power cable, re-plug and
contact clean
2. The screen supporting board is broken 2. Replace the screen supporting board
3. The screen is damaged 3. Replace screen
4. No power access 4. Check the power
4.1.4 Fault-crash (keep the boot interface; the screen is stuck, and time stops)
Cause of failure: Solution:
1. The parameters of the lower computer are lost 1. Re-install the system
4.1.5 Fault-The instrument results cannot be transmitted to the hospital lis system
Cause of failure:
1. The server ping cannot ping to the instrument
2. The instrument IP and lis server IP are incorrectly filled in
3. The network interface of the core board is in poor contact or damaged
4. The network cable is damaged: The hospital computer network port is badly connected or damaged or
the hospital Lis software is fault and cannot accept the data
Solution:
1. Ping the ip of the instrument to check if it is successful, and it fails, check whether the (network
cable/machine network port/computer network port) is normal;
2. Check whether the instrument ip and lis server ip are filled in correctly;
3. Replace the mainboard;
4. Replace the network cable, inform the information department of the hospital for repair, and contact the
hospital Lis engineer for maintenance.

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4.1.6 Fault-the interface temperature shows 0°C
Cause of failure: Solution:
Transmission base temperature sensor is damaged Replace the temperature sensor
4.1.6 Fault-abnormal heating
Cause of failure: Solution:
1. The temperature sensor is damaged 1. Replace the temperature sensor
2. The heating cable is damaged 2. Replace the heating cable
3. The heating plate is damaged 3. Replace the heating plate
4.1.7 Fault-The system time is automatically restored to the factory setting
Cause of failure: Solution:
1. The power on the screen supporting board is 1. Replace the battery on the screen supporting
exhausted board
2. The time crystal is damaged (low probability) 2. Replace the screen supporting board

4.1.8 Fault-automatic restart during the test, or cannot print, restart when start
printing
Cause of failure:
It is mixed use with the flight test PLUS power adapter, resulting in unstable voltage
Solution:
Use the original FS-114 power adapter and check the internal line socket of the instrument

4.2 The printer unit

Fault: It is unable to print, and incomplete printing, overlapping printing content, etc. occur.
Generally, the above undesirable fault may be caused by damage to the components of the printer or
software, or it may be caused by damage to the components of the display screen supporting board.
Solution:
Clean the dust or debris on the roller
Make sure the printing paper direction is correct (smooth side up)
Replace the printer components

4.3 Drive system unit

4.3.1 Fault-The card slot fails to reset, and the card slot protrudes abnormally
Cause of failure Solution:
The reset optocoupler is abnormal Replace it

4.3.2 Fault-ID chip does not match the reagent batch

Cause of failure:
1. The batch number of the chip card and that of the test card do not match
2. The barcode of the reagent card is scratched

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3. The test card is not inserted in place
4. The parameters of the laser light source are wrong
Solution:
1. Use the test card for FS-114
2. Replace the test card
3. Re-insert in place
4. Refer to "Red Light Calibration" to adjust the laser light source, see 4.4 in this manual for details.

4.4 Tips

4.4.1 Judgment skills of printer components

1. Check the cable socket, port

Figure 4-4-1 Printer Figure 1

2. Observe the indicator light inside the module, as shown in Figure 4-4-2: the green light is flashing, and
the red light is always on, which is the normal state.

Figure 4-4-2 Printer Figure 2

3. Open the printer assembly, you will find two buttons, as shown in Figure 4-4-3: long press the right
button, the printer can continuously output paper and is in a normal state.

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 Figure 4-4-3 Printer Figure 3

4.4.2 Battery Installation

1. Material:

2. Installation steps:
(1) Install gasket:

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(2) Install the battery and the connecting line:

(3) Install the shell and screws:

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