Genrui FA50 User manual

Intellectual Property
© 2004-2021 Genrui Biotech Inc. All rights reserved.
Genrui Biotech Inc. (hereinafter called Genrui) owns the intellectual
property rights to this product and this manual.
Without prior written consent of Genrui, any person or entity is
strictly forbidden to use, disclose or allow others to obtain any
information in this manual by any means, and any materials
contained in this manual shall not be photocopied, reproduced or
translated into other languages.
Genrui reserves the right to modify and update this manual without
prior notice.
Genrui reserves the right of final interpretation for this manual.
, are registered trademarks of Genrui.
Statement
Genrui shall be liable for product safety, reliability and performance
provided that the following requirements are met:
1）All installation operations, expansions, changes,
modifications and repairs of this product are conducted by
Genrui authorized personnel.
2）All replaceable parts involved in maintenance as well as
the related accessories and comsumables are original or

approved by Genrui.
3）Any associated electrical equipment complies with national
standards and the requirements of this manual.
4）Use and operation of this product are performed in strict
accordance with this manual.
Warranty
Genrui warrants that Genrui’products meet the labeled
specifications of the products and will be free from defects in
materials and workmanship that occur within warranty period.
The warranty is void in cases of:
◼Damage caused by accidents.
◼Damage caused by mishandling during shipping.
◼Malfunction or damage caused by force majeure such as fire and
earthquake.
◼Malfunction or damage caused by unstable or out-of-range power
input.
◼Malfunction or damage caused by improper operation or repair by
unauthorized service people.
◼Malfunction of the analyzer whose serial number is not legible
enough.
◼Others not caused by instrument itself.

If a product covered by this warranty is determined to be
defective because of defective materials, components or
workmanship, and the warranty claim is made within the warranty
period, Genrui will, at its discretion, repair or replace the defective
part(s) free of charge.
Customer Service Department
Manufacturer:
Genrui Biotech Inc.
Address:
4-10F, Building 3, Geya Technology Park,
Guangming District, 518106, Shenzhen, China
Website URL:
www.genrui-bio.com
E-mail
Address:
[e-mail]
Tel:
[phone]
Fax:
[phone]

⚫This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) this device may not
cause harmful interference, and (2) this device must accept
any interference received, including interference that may
cause undesired operation.
Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to
operate the equipment.
This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause
harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.

-- Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for
help.
⚫This analyzer can only be operated by test professionals, doctors
or laboratory technicians who have been trained by Genrui or
its distributors.
⚫It is important for the hospital or organization that employs this
equipment to carry out a reasonable service/maintenance plan.
Neglect of this may result in machine breakdown or injury of
human health.
⚫Be sure to operate the analyzer under the situation specified in
this manual; otherwise, the analyzer will not work normally and
the test results will be unreliable, which would damage the
analyzer components and cause personal injury.
This operation manual is written for the following laboratory
professionals:
1.Daily system operator.
2.Personnel for system maintenance and troubleshooting.
3.Learners for system operation.
Commented [G1]:

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual i
Introduction
We would like to sincerely thank you for choosing to purchase
Genrui product.
Please read this manual carefully in order to ensure correct use of
the product. After carefully reading this manual, please keep it
safely stored so that you can refer to it when necessary.
Product Name: Quantitative Immunoassay Analyzer
Model: FA50
Product Composition: The analyzer is mainly composed of the
host, which includes microprocessor, detection system, LCD
screen and printer.
Scope of Product Application: The analyzer is used to
quantitatively test human samples with particular dry reagents,
which are based on the immunofluorescence technique.
Manufacturer: Genrui Biotech Inc.
Registered Address: 4-10F, Building 3, Geya Technology Park,
Guangming District, 518106, Shenzhen, China

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
ii FA50 Operation Manual
Date of Manufacture: See the nameplate of the instrument
Manual Preparation Date: August 22, 2019
Manual Revision Date: January 7, 2021
Item No.: P01.91.300417-02
FCC ID：2AZC7FA5001
51000001
Commented [G2]:

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual iii
Manual Overview
This chapter introduces how to use the operation manual of your
FA50 Quantitative Immunoassay Analyzer (hereinafter called the
analyzer). This manual is supplied with the analyzer and contains
detailed descriptions of the usage, function and operation of the
analyzer. Before operating the analyzer, read this manual carefully
and understand its contents, in order to usethe analyzer properly to
play its best performance and guarantee the operator’s safety.
⚫Strictly follow instructions in this manual to operate the analyzer.
Who Should Read This Manual
This manual contains information written for clinical laboratory
professionals or trained doctors, nurses or laboratory technicians
to:
1.Learn about hardware and software of the analyzer.
2.Set system parameters.

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
iv FA50 Operation Manual
3.Perform daily operations.
4.Perform system maintenance and troubleshooting.

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual v
How to Find Information
If you want to...
Please refer to...
learn about the use of the
analyzer
1.Precaution, warning and
note
learn about the installation
requirements
2.Installation
learn about the intended use
and measurement parameters
of the analyzer
3.System Description
learn about the measuring
principle and process
4.Working Principle
learn about the settings of
date, time, parameters, units,
etc. and result query
5.Interface and Operation
learn about the sample
collection and preparation
methods and sample analysis
process
6.Sample Test Process

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
vi FA50 Operation Manual
If you want to...
Please refer to...
learn about the maintenance,
service and detection methods
7.Maintenance
learn about fault causes and
handling methods
8.Troubleshooting
learn about the
transportation and storage
conditions of the analyzer
9.Transportation and
Storage
learn about common
reagents and consumables
for the analyzer
10.Reagents and
Consumables
learn about the technical
specifications of the analyzer
Appendix A. Specifications
learn about the hazardous
substances that may contain
in the analyzer parts
Appendix B. Hazardous
Substances

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual vii
Symbols
You will find the following symbols in this manual:
Symbols
Meaning
Alerts the operator to follow the statement
below the symbol, otherwise it may take the
risk of potential biohazard.
Alerts the operator to follow the statement
below the symbol while in operation, otherwise
it may cause personal injury.
Alerts the operator to follow the statement
below the symbol while in operation, otherwise
it may lead to analyzer damage or unreliable
analysis results.
Alerts the operator to follow the statement
below the symbol, which emphasizes the
important information or special attention to be
paid while in operation.
You may find the following symbols on the analyzer, reagent, QC or
calibrator:

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
viii FA50 Operation Manual
Symbols
Meaning
Consult accompanying documents.
Inflammation
Do not use inflammable hazardous articles
near the instrument, such as alcohol, diethyl
ether, etc.
Electric Shock
1) When the power supply is turned on,
unauthorized service technicians are prohibited
to open the analyzer’s panel.
2) Avoid spilling any liquid onto the workbench.
If liquids penetrate into the analyzer, please
turn off the power supply immediately and
contact Genrui promptly.
Strong Light
Do not stare at the laser beam directly,
otherwise, the eyes will be injured.

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual ix
Symbols
Meaning
Biohazard
Description for this label:
background color –yellow
symbol and outline –black
1) All the test samples, calibrators, quality
controls, etc. should be regarded as infectious.
Gloves should be worn when handling them.
2) All the waste liquids should be regarded as
infectious, gloves should be worn while in
touch; All the items contacted with the test
samples, such as test cards, pipette tips, etc.
should be regarded as infectious, gloves
should be worn while in contact.
3) All the wastes are potentially infectious and
should be regarded as medical wastes and
disposed according to the current regulatory
requirements.
4) When the service life of the instrument ends, it
should be disposed according to the local
requirements of environment department; it
cannot be disposed and discarded as common
wastes.

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
x FA50 Operation Manual
Symbols
Meaning
Warning symbol for high temperature
Corrosion
Cleaning solution has potential chemical
corrodibility. Wear protective gloves while in
operation.
Symbol for protective earthing
Symbol for functional earthing
Alternating current symbol
For in vitro diagnostic use only

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual xi
Symbols
Meaning
Batch code
Expiry date
Serial number
Production date
Manufacturer
Storage temperature

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
xii FA50 Operation Manual
Symbols
Meaning
Refer to the Operation Manual
This electronic product contains some
poisonous and harmful substances. The
environmental protection use period is 20
years, after this period, it should be put into the
recycling system.

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
FA50 Operation Manual xiii
Table of Contents
Introduction..........................................................................................i
Manual Overview ............................................................................. iii
Who Should Read This Manual ....................................................... iii
How to Find Information....................................................................v
Symbols........................................................................................... vii
Table of Contents ............................................................................xiii
1Precaution, warning and note....................................................1
2Installation....................................................................................3
2.1 Introduction............................................................................3
2.2 Installation Requirements......................................................3
2.2.1 Installation environment.................................................3
2.2.2 Power requirements.......................................................5
2.3 Connection of the Analyzer ...................................................6
2.3.1 Unpacking and placing the analyzer..............................6
2.3.2 Connecting the power cable ..........................................7
2.3.3 Connecting the equipotential terminal ...........................7
2.3.4 Installing (replacing) the printing paper..........................7
3System Description...................................................................10
3.1 Front View ...........................................................................10

Error! Use the Home tab to apply 标题 1 to the text that you
want to appear here.
xiv FA50 Operation Manual
3.2 Back View............................................................................11
3.3 Function of the Parts ...........................................................12
3.3.1 LCD screen..................................................................12
3.3.2 Test slot .......................................................................12
3.3.3 Magcard induction zone...............................................12
3.3.4 Printer...........................................................................12
3.3.5 Network port.................................................................12
3.3.6 Power switch................................................................13
4Working Principle......................................................................14
4.1 Overview..............................................................................14
4.2 Measuring Principle.............................................................14
5Interface and Operation............................................................16
5.1 Overview..............................................................................16
5.2 Common Interface Operations ............................................16
5.3 Startup.................................................................................17
5.4 Main Menu...........................................................................18
5.5Test......................................................................................19
5.5.1 Item Set........................................................................20
5.5.2 ID Set...........................................................................21
5.5.3 STD Mode....................................................................21
5.5.4 Fast Mode....................................................................24
5.6 Result...................................................................................26
5.7 QC .......................................................................................31