s

KU-F20
Feces Analyzer

User
Manual

Zhuhai Keyu Biological Engineering Co. ,Ltd.

1
 Copyright and Statement
Congratulations on becoming a valued customer of Zhuhai Keyu Biological Engineering
Co. ,Ltd. Welcome to use a series of Feces Analyzers, which will bring you a new
experience and convenience.
This product manual has been prepared in accordance with the relevant laws and regulations
in China and the specific conditions of the Feces Analyzer manufactured by Zhuhai Keyu
Biological Engineering Co. ,Ltd. The user manual of this product contains the latest
information before printing of this product manual. Zhuhai Keyu Biological Engineering
Co. ,Ltd. is fully responsible for the revision and explanation of the product manual, and
reserves the right to change the relevant contents of this product manual without prior notice
after printing. Some pictures in this product manual are schematic drawings, and are for
reference only. If the pictures do not match with the actual objects, the actual ones shall
prevail.
All the materials in this product manual are protected by copyright law. Without the prior
written consent from Zhuhai Keyu Biological Engineering Co. ,Ltd, no part of the product
manual could be copied or translated into other languages.
The operator must strictly follow the instructions in this product manual. Otherwise,
Zhuhai Keyu Biological Engineering Co. ,Ltd. is not responsible for any errors or
instrument failures caused by illegal operations.

Limited quality and responsibility guarantee：

This product manual clarifies the rights and obligations between Zhuhai Keyu
Biological Engineering Co. ,Ltd. and its users regarding the quality assurance
responsibility and after-sales service of the products and the agreement of its
occurrence and termination.
If the instruments, sold by Zhuhai Keyu Biological Engineering Co. ,Ltd. and its
authorized agents, are violated due to manufacturer or material problems during the normal
use, Zhuhai Keyu Biological Engineering Co. ,Ltd. will provide one year warranty service
from the date of sale of the instrument.
The inspection by Zhuhai Keyu Biological Engineering Co. ,Ltd. is not perfect.
The obligations under Zhuhai Keyu Biological Engineering Co. ,Ltd. are only for
maintenance, and do not include economic losses or additional expenses caused by the
deactivation of the instrument. Examples include:
 Freight (including customs fees).
 The Economic and time loss caused by the inability to use the instrument
 Boarding, dining or other expenses along the way.
 The loss caused by inconvenience.
 Other expenses.

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Zhuhai Keyu Biological Engineering Co. ,Ltd. is not responsible for any direct, indirect or
eventual damage caused by the following conditions. Zhuhai Keyu Biological
Engineering Co. ,Ltd. will no longer be responsible for the safety, reliability and operation
of the instrument since the occurrence of the following conditions. At the same time, it is
considered that the product quality assurance responsibility, after-sales service rights and
obligations and its production and termination of the agreement in product manual, all
agreed free service rights will be deemed unconditionally abandoned permanently.
 Unusual, unmaintained or damaged instrument.
 Using the reagents and accessories that are not provided or approved by Zhuhai
Biological Engineering Co. ,Ltd
 Instrument damage caused by misuse or negligence due to user or other person
not operating in accordance with the analyzer's product manual
 Replacing the parts that have not been approved by Zhuhai Keyu Biological
Engineering Co. ,Ltd. or those who maintain, repair or modify the instrument,
but have not been authorized by Zhuhai Keyu Biological Engineering Co. ,Ltd..
 Components are disassembled, stretched, re-commissioned.
Note: Zhuhai Keyu Biological Engineering Co. ,Ltd. does not undertake any implied
warranty for the marketability and applicability of the instrument for a particular
purpose.
We encourage you to call us when you encounter any technical problems during use. The
after-sales service department of Zhuhai Keyu Biological Engineering Co. ,Ltd. has
opened product technology and service hotline to provide technical support and
troubleshooting for users.
If the instrument encounters misfunction, please keep the relevant samples and immediately
notify the authorized agent by Zhuhai Keyu Biological Engineering Co. ,Ltd..
[Registrant]
Registrant: Zhuhai Keyu Biological Engineering Co. ,Ltd.
Address: 2nd Floor, Building D, No. 288, Airport East Road, Sanzao Town, Jinwan
District, Zhuhai City
Telephone:0756-6821168
After-sale service: Zhuhai Keyu Biological Engineering Co. ,Ltd.

[Manufacturer]
Name: Zhuhai Keyu Biological Engineering Co. ,Ltd.
Address: 2nd Floor, Building D, No. 288, Airport East Road, Sanzao Town, Jinwan
District, Zhuhai City

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 Business phone: 0756-6821170; Fax: 0756－6821169

E-mail: export@keyubio.com Website: http://en.keyubio.com

Publication version：V1.0.0 Revision date:2019.06.03

In vitro diagnostic medical device

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Preface
1. Safety instructions
This instrument is a valuable precision electronic medical analysis instrument. In order to avoid
serious damage to the instrument and people caused by possible electric shock, please turn off the
total power before moving the instrument.
It is recommended that you use a regulated power supply with a power of 400VA or more.
When you connect a new hardware device to the instrument, make sure to unplug all the power
cables, and connect the data cable of the device, and then connect the power cable.
If you want to use the plug-and-play equipment to edit the data in the instrument computer, Zhuhai
Biological Engineering Co. ,Ltd. reminds you that this operation may interrupt the operation of the
instrument or cause a crash. The security of your plug-and-play devices and instruments is not
guaranteed by Zhuhai Keyu Biological Engineering Co. ,Ltd.
Before you install or use this instrument, please read the relevant information provided in this
product manual.
Strong light, dust, high temperature and humidity, as well as severe vibration and shaking, will
affect the accuracy and longevity of the instrument, so please be careful to avoid these.
When routinely maintaining the instrument, please note that there may be biological contamination
of the autosampler, sampling needle, instrument built-in tubing, flow counter, waste tubing, and
waste barrel due to frequent contact with stool specimens. When cleaning or replacing these parts,
please pay attention to wearing disposable gloves or other protective equipment.

2.About product manual

This user's product manual contains general information about the instrument's use. This is the best
data guide for new users . Many users read the product manual from beginning to end before using
it for the first time. If you also read this product manual, you will learn about the features and
operation of the instrument. In your daily use, you can use the contents to quickly find the
information you need.
All people who use,move and maintain the instrument should read this product
manual.
Conventions used in this product manual.
Warning:
It is the information that you should know about how to avoid injury to the operator or
others.

Caution:
It is the information that you should know about how to avoid damage to your

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 equipment and lead to untrusted analysis.

Attention:
It is an important step that you should know.

3.About the product package

After obtaining the product packaging from Zhuhai Keyu Biological Engineering Co. ,Ltd. Or from
the agent, please open the package with the engineering and technical personnel from manufacturer
or authorized by manufacturer to check whether the standard accessories are attached. As listed in
the Packing List, if there is any serious mechanical damage.

4. Where to find more information about the product

You can get more product information and upgrade information related with this instrument through
Zhuhai Keyu Biological Engineering Co. ,Ltd..
1. You can find the latest information about fecal analysis product from KU series
from the website http://en.keyubio.com/
2. The other documents:
In addition to the standard accessories listed in this product manual, you may also have
other documents in your product packaging, such as the latest product information from
Zhuhai Keyu Biological Engineering Co. ,Ltd., and the product warranty attached by the
agent etc..

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 Contents
Copyright and Statement.................................................................................................................................................................... 2

Preface................................................................................................................................................................................................ 5

Contents.............................................................................................................................................................................................. 7

Chapter 1 Introduction of The Instrument......................................................................................................................................... 1

1.1 Instrument Overview.......................................................................................................................................1

1.2 Reagent system................................................................................................................................................4

1.3 Reagent dosage................................................................................................................................................5

1.4 Storage and use environment.......................................................................................................................... 5

1.5 Software Operating Environment................................................................................................................... 6

1.6 Data Interface.................................................................................................................................................. 7

1.7 User Access Control........................................................................................................................................7

1.8 User Permission Control................................................................................................................................. 7

1.9 Service life...................................................................................................................................................... 7

1.10 Weight and size............................................................................................................................................. 7

Chapter 2The working principle of instrument.................................................................................................................................. 8

2.1 Basic working principle of the instrument......................................................................................................8

2.2 The workflow of the instrument..................................................................................................................... 8

2.3 Specifications of the instrument....................................................................................................................... 8

2.4 Application Scope of Product......................................................................................................................... 9

2.5 Limitation of Product...................................................................................................................................... 9

Chapter 3Instrument installation...................................................................................................................................................... 10

3.1 Unpacking and checking............................................................................................................................... 10

3.2 Installation requirements............................................................................................................................... 10

3.3 Power Check................................................................................................................................................. 11

3.4 Reagent System Connection......................................................................................................................... 12

3.5 Connection of monitor, mouse, and keyboard.............................................................................................. 13

3.6 Instrument host power cord connection........................................................................................................ 13

3.7 Instrument start up........................................................................................................................................ 13

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 3.8 Printer Connection (Other Configuration).................................................................................................... 14

Chapter 4Daily operation of the instrument.....................................................................................................................................15

4.1 Daily operation precautions.......................................................................................................................... 15

4.2 Starting.......................................................................................................................................................... 15

4.3 Testing........................................................................................................................................................... 17

4.4 Sample information....................................................................................................................................... 18

4.5 Review and Print........................................................................................................................................... 20

4.6 Emergency.....................................................................................................................................................24

4.7 Sample retest................................................................................................................................................. 26

4.8 Querying Historical Data.............................................................................................................................. 27

4.9 Quality Control............................................................................................................................................. 27

Click<Set>→<Quality Controls> into controls information edit interface....................................................... 28

4.10.2 Controls information query...................................................................................................................... 28

4.10.3 Controls automatic operation................................................................................................................... 30

1) Quality controls preparation......................................................................................................................... 30

2) Prepare the bottle sleeves that are compatible with the quality control packaging....................................... 30

3) New create waited control sample.................................................................................................................. 31

4) Quality controls placement............................................................................................................................. 31

5) Quality control detect..................................................................................................................................... 31

Chapter 5 Maintenance.................................................................................................................................................................... 32

5.1 Focus..................................................................................................................................................................... 32

5.2 Shooting parameters.............................................................................................................................................. 34

5.3 Reagents................................................................................................................................................................ 35

5.4 Record................................................................................................................................................................... 37

5.5 Daily maintenance of the instrument.................................................................................................................... 37

5.6 Instrument maintenance........................................................................................................................................ 39

Chapter 6 Settings.................................................................................................................................................................... 40

6.1 Colloidal Gold Card Settings........................................................................................................................ 40

Figure 6-1 Colloidal gold card settings...............................................................................................................40

6.2 Printing settings.............................................................................................................................................41

6.3 Communication Settings............................................................................................................................... 42

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 6.4 The connection of LIS system...................................................................................................................... 42

Attention 44

6.5 Project setting................................................................................................................................................ 45

Chapter 7User Management............................................................................................................................................................. 46

7.1 Operator Management.................................................................................................................................. 46

7.2 Inspection doctor management..................................................................................................................... 46

7.3 Logout........................................................................................................................................................... 47

Chapter 8Troubleshooting................................................................................................................................................................ 48

8.1 Troubleshooting Guide................................................................................................................................. 48

8.2 Seeking technical support............................................................................................................................. 48

8.3 Handling precautions for stopping the equipment due to repairing or handling..........................................49

8.4 The failure of computer operating system and hardware............................................................................. 49

8.5 The failure of instrument application part.................................................................................................... 50

Chapter 9Prevention, limitation and harm....................................................................................................................................... 51

9.1 Restrictions on use........................................................................................................................................ 51

9.2 Installation restrictions.................................................................................................................................. 51

9.3 Personal protection and infection control..................................................................................................... 52

9.4 Toxic and harmful substances in products and their contents...................................................................... 52

Appendix 1:Accessories................................................................................................................................................................... 56

Appendix 2: Symbol.........................................................................................................................................................................58

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Chapter 1 Introduction of The Instrument
1.1 Instrument Overview
The instrument is called Feces Analyzer (hereinafter referred to as the instrument). It is the latest
development and production from Zhuhai Keyu Biological Engineering Co. ,Ltd. (hereinafter referred
to as the company). It is a test instrument integrating multidisciplinary fields and modern high
technology. In order to ensure the accurate quantification of the sample, a specimen collection cup
was specially designed for sample collection, and the specimen collection cup can filtering fecal
residue.

The instrument has complete and thorough pipeline and automatic cleaning function to prevent
cross-contamination of the sample as much as possible. To ensure the accuracy and repeatability of
the test results, the instrument uses a precision syringe pump to precisely control the micro-samples.
The independent mixing system is used for stool analysis.

In order to ensure that the instrument can capture clear images quickly and stably, the instrument is
equipped with an automatic microscope that uses a precision lead screw to adjust the focal length. The
controllable precision is greatly improved. The automatic microscope axes can be automatically controlled,
and the image collector with more than 2 million pixels can greatly improve the quality of the images taken
by the instrument and ensure the reliability for the detection results of various specimens.

The instrument uses a multi-channel counting pool with forced cut-off at both ends of each channel. The
sample is fast and static, and cooperates with the auxiliary settlement function of the instrument, leading rapid
settlement of the forming points.

The instrument has 20 colloidal gold card detection channels, which can detect 5 items at the
same time. Each colloidal gold card box can hold 20 cards, take photos and save the detection
results, and assist in identification.

The instrument has high degree of automation and simple operation procedures. It is equipped with an
automatic sample feeding device and a liquid level alarm device. After the operator puts the sample into the
sample holder, it can be injected, diluted, mixed, sampled, imaged and cleaned. Automated by the instrument,
the results are reported in XX/HP or XX/LP or +. The doctor only needs to enter the patient data and review the
results to print the report. The instrument stores patient clinical data, microscopic result, traits, colloidal gold
items, and other extensions. Various data categories are stored, which facilitates quick browsing, query, editing,
printing and transmission of data. All data is fully realized in database management, providing a common
database interface, which can be easily connected to the hospital's HIS and LIS systems. It is an ideal equipment
for clinically physical and chemical testing of feces.

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 Start button

Sample tray

Sample Tray

Figure 1.1 The front view of the instrument

Warning
 Do not open the instrument cover during work to prevent electric shock.
 Please ensure that the instrument is well grounded to prevent static electricity.
 When the instrument on running, the operator should not touch the moving
parts, and be careful on the handle and pinch.
 Pay attention to the left and right tray protection cover when pulling, be
careful on the pinch.
 The sampling needle is sharp enough to cause the risk of perforation.

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1.1.1 Main components and the functions
The analyzer consists of a control system, an optical flow counter (OSA), a suction needle, a
specimen collection cup, a connecting pipe, a pump, a solenoid valve, a power supply, a fully
automated biological microscope, and a CMOS image processor (camera). The electronic control
mainly completes the automatic dilution, mixing, aspirating, cleaning, image shooting and other work
processes of the stool sample; the computer and its display components mainly complete the friendly
human-computer interaction interface, and are responsible for data analysis, display and storage of the
captured image; the liquid pipeline part mainly completes the liquid guiding and discharging during
the whole test process; and the whole system needs the function of the mechanical structure to achieve
the function.

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 1.1.1.1 Electronic Control Unit
1) Control the on/off of the solenoid valve for the on/off control of the liquid path.

2) Control the on/off of the pump to provide power for the liquid circuit.

3) Control the operation of the injection stepper motor to power the autosampler system.

4) Control the operation of the microscope stepper motor to power the automatic operation of
the microscope.

5) Control the light source to control the light source of the microscope.

6) Control the camera, automatically set the camera's related parameters and capture images.

7) Control the operation of all optical and electrical switches.

1.1.1.2 Microscope imaging unit

The microscope imaging unit is mainly composed of a microscope, a camera, a flow
counting chamber etc..

1) The flow counter chamber provides the carrier for the sample.

2) The microscope magnifies the formed element in the sample.

3) The camera collects the microscopically enlarged image.

1.1.1.3 System Control Unit

The system control unit consists of a PC motherboard and storage media (hard disk, memory
module, etc.) and display. The instrument is equipped with system control software, database, etc.

1) Communicate with the electronic control unit to control the operation of the instrument.

2) Save the captured image.

3) Receive test results from other medical instruments and communicate with Lis system.

4) Implement human-computer interaction.

1.1.1.4 Pipe unit

The pipeline unit is mainly composed of a solenoid valve, a pump, a syringe and a sampling needle,
and provides a passage and a carrier for samples, reagents and waste liquid.

1.2 Reagent system

In order to maintain the best performance of the instrument, the company developed a special reagent for
the feces analyzer. These reagents were tested and all qualified. The use of non-Corporate reagents can affect
the performance of the instrument, cause serious measurement errors, and can cause accidents. All reagents
must be stored at room temperature to maintain optimal chemical performance. All reagents should avoid
excessive cooling, overheating and direct sunlight during storage. If the temperature is lower than 0 °C, the
reagent will freeze and cause the chemical and electrical properties of the reagent to change.

In the process of using the instrument, in order to minimize the evaporation of the reagent and reduce the
pollution of the external reagent,the reagent container is tightly closed, and the pipeline is inserted into the
reagent through the container lid. However, the quality of the reagents will change over time and all reagents
must be used within the validity period.
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 1.2.1 Diluent

The diluent is a stable isotonic solution. It should meet the following test requirements:

 Dilute the sample

 Maintain cell morphology during measurement.

 Provide background image.

 Used as a routine cleaning of the instrument,flushing the inner and outer walls of the
sampling needle, the counting chamber and the liquid path to prevent cross-contamination.

1.2.2 Cleaning solution

 Used as the shutdown maintenance of the instrument, i.e. the instrument will automatically
charge all the counting channels into the cleaning solution before exiting the program every
day. When the machine is turned on again, the instrument will automatically discharge the
cleaning liquid in the pipeline and clean the pipeline with the diluent.

1.2.3 Maintenance solution

 The maintenance solution contains high-efficiency oxides and is used as a powerful

cleaning device. It is mainly used when the counting chamber or piping system is
seriously polluted. For example, if there are many stains or more sticks in the image under
the microscope, the cleaning liquid can not be washed away or cleared.

Warning
 All reagents are for in vitro diagnostic, If contacting with eyes, skin, etc., please
rinse with plenty of water.

Be careful
 Please keep or use according to the environmental requirements of the reagent
kit. It can't be frozen or warmed; Keep away from the open power supply unit;
use within the validity period.

1.3 Reagent dosage

Diluent: about 13-17mL / sample

Cleaning solution: about 10mL / times of shutdown

1.4 Storage and use environment

1.4.1 Power supply

Voltage: AC100-240V.

Frequency: 50Hz.

Power ≤200VA.

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 1.4.2 Storage and transportation environment
Environment temperature: -10℃～40℃.

Relative humility: ≤93 RH.

1.4.3 Environment conditions for use

 Optimal environment temperature: 10~30℃.

 Relative humility ≤70%.

 Atmospheric pressure: 76kPa~106kPa.

 Have a good grounding environment.

 The instrument should be placed on a fixed and stable workbench (at least
1500mm×800mm). The workbench can withstand objects above 120KG, and the rear of the
host should be no less than 40cm away from the wall.

 Keep away from strong electromagnetic interference sources.

 Avoid direct sunlight.

 Keep away from sources of vibration interference.

 The power jack should meet the electrical specifications and must have a reliable grounding
wire.

1.5 Software Operating Environment

1.5.1 Hardware Configuration
 Memory: 2 GB (DDR3L 1600MHz) or higher

 CPU: Intel Pentium 4 or AMD Athlon 64 processor or higher

 Hard disk: 500GB (7200 rpm) or higher

1.5.2 Software Environment

 System software: Windows 7 64 digits

 Anti-virus software: none

 Network conditions: If you need to communicate with Lis or His system, you need a
network connection.

 Supporting software: Lazarus,Opencv,Caffe

 Application software: none

1.5.3 Security Software Update Requirements

None.

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1.6 Data Interface
RJ45 network interface, HL7 communication protocol.

1.7 User Access Control

You must insert a dongle to start the software and log in with your account password.

1.8 User Permission Control

User accounts are available for both administrators and regular users. The difference between
the administrator and the regular user is that the administrator has the function of modifying and
setting the print, communication, and microscopic item modules, while the ordinary user only has
the view function.

1.9 Service life

The best service life of the instrument is 5 years. The production date of the instrument can
be found in the certificate associated with the instrument.

1.10 Weight and size

 Dimension of the host: 800×760×640mm

 Weight of the host: about 70kg

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 Chapter 2 The working principle of instrument

2.1 Basic working principle of the instrument

The instrument uses the principle of fecal microscopy image analysis. The stool sample is
automatically diluted, mixed, and the colloidal gold is spotted. After the sedimentation, the formed element
of the feces is photographed by the camera, the colloidal gold detection card is photographed, and the
colloidal gold item is automatically interpreted. The results are reported after a manual review.

2.2 The workflow of the instrument

The program controls the automatic sample introduction device to send the sample to the designated
sampling position, and after the sample is diluted and mixed by the syringe, the syringe is matched with the
sampling needle to sequentially suck a certain amount of the sample to be inspected into the flow counting
chamber. The colloidal gold card is spotted. After the sample in the counting chamber is settled for a certain
period of time, the components in the flow counting cell are microscopically enlarged by a microscope, and
the computer-controlled camera collects a plurality of images collected from the sample that are distributed
in the visual field. A standard stool analysis report is formed based on image processing results.

Emergency

Sample delivery Shooting Dilution Mixture Filtering Sampling

traits

Shooting Colloidal
colloidal gold Waiting
gold spotting

Shooting
Cleaning form Settlement

Figure 2-1 Instrument testing process

2.3 Specifications of the instrument

It should have functions of automatic sample feeding, automatic cleaning, automatic mixing,
automatic filtering, automatic sample suction and automatic cleaning;

The specimen collection cup is automatically withdrawn after the injection, and can be
reviewed.

It should be able to shoot the sample characters and save pictures;

It Should have the ability to simultaneously test multiple fecal colloidal gold detection items
and take pictures of the results;

There should be 20 (including 20) colloidal gold project detection channels;

The counting chamber should have 2 (including 2) or more channels;

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 It should have automatic loading and exit function of colloidal gold detection reagent;

It should have emergency function, the emergency samples should be inspected

immediately after arrival;

It should be able to carry out automatic batch inspection, and at least 50 (including 50) samples
can be tested per batch;

It should be able to take pictures of the formed elements in the feces and manually mark the
component categories;

It should be able to print graphic reports and report microscopic results in xx/HP or xx/LP or
qualitative method (-, +, ++, +++, ++++);

It should be able to query the original data;

It should have a data interface connected to Lis, His;

It should have the function of automatically interpreting the pictures taken by the colloidal
gold detection project.

It should have built-in barcode scanning function .

The maximum detection of KU-F20 should be no less than 85/hour.

2.4 Application Scope of Product

It is applicable for microscopic examination of formed element in stool specimens and qualitative detection
of colloidal gold method in fecal specimens.

2.5 Limitation of Product

The number of pictures collected is limited. When the number of parasite eggs is small, the pictures
collected may not be photographed. According to the results of the pictures, the results may be
missed. It is recommended to manually smear the microscope;

The instrument's own software does not have the function of forming a sub-identification. The
result is related to the reviewer's knowledge and experience accumulation.

Be careful
Only the colloidal gold test reagent card approved by the company can
achieve the ideal interpretation result.

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 Chapter 3 Instrument installation

In order to achieve the best performance of the instrument and achieve satisfactory clinical results, the
first installation must be installed and debugged by an engineer authorized by the company. The instrument
must be installed or used in accordance with this installation procedure.

Be careful
The installation of the instrument by any unauthorized or untrained personnel may
result in damage of the instrument, and such damage is not covered by the company's
free warranty. Anyone who has not been authorized by the company cannot install or use
the instrument.

3.1 Unpacking and checking

Carefully remove the instrument and accessories from the box and save the packaging
materials for later transportation or storage.

1) Please check the attachment according to the packing list.

2) Check if there is flooding.

3) Check for any mechanical damage.

4) Check all the exposed wires, inserts and accessories.

Please be sure to remove the instrument and accessories from the box with the manufacturer
or authorized engineer.

If you have any questions, please contact the company.

3.2 Installation requirements

1) When transporting the equipment, you must reach into the bottom of the equipment and lift
the bottom of the equipment for handling.

2) Power supply selection and connection: Select separate power supply as required; if
necessary, install an uninterruptible power supply (UPS) of 400VA or more to ensure
normal operation.

3) Power-on check: Turn on all power switches to ensure normal data transmission and see if
the various components of the instrument are operating normally. The abnormal problem is
handled by the field engineering technician.

4) When placing the device, please do not block the power plug and socket of the device to ensure that
the plug can be disconnected and the device is powered off in case of emergency.

5) Connection of communication line: display, keyboard, mouse, printer.

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 Warning
 This instrument cannot be used at home.
 This instrument is not a treatment device.

Be careful
 The instrument should be protected from direct sunlight.
 The working environment of the instrument should be protected from
excessive cold and overheating. If the humidity too high,the counting chamber
surface will have water marks.
 The working environment of the instrument should avoid centrifuges and X-
ray machines.
 Do not use equipment such as mobile phones or wireless phones that generate
excessive radiation fields near the instrument. Excessive radiation field can
interfere with the normal operation of the instrument.

3.3 Power Check

Before installing the instrument, you must check whether the power supply at the installation
site meets the requirements of the instrument. The specific power requirements are as follows:

Voltage: AC100-240V.

Warning
 The grounding post on the rear panel of the instrument must be directly
connected to the ground through the grounding wire. The user is obliged to
ensure the reliability of the grounding power supply protection of the
instrument.
 Before the instrument is connected to the power supply, check whether the
electrical plugs of the instrument are connected correctly and reliably.

11
 Be careful
 Frequent voltage fluctuations can reduced performance and reliability of the
instrument. Users should solve this problem before using the instrument, such
as installing an AC voltage regulator (required by the user).
 Frequent power interruption will lead to serious degradation of instrument
performance and reliability. Users should solve this problem before using the
instrument, such as installing an uninterruptible power supply (UPS) (required
by the user).

3.4 Reagent System Connection

3.4.1 Connection of Sample Diluent Pipe
Remove the pipe with the connector from carton. Connect with the same color liquid port on the back
panel of the host. Insert the other end of the pipe into the sample diluent bottle and tighten the cap. The
sample diluent bottle must be placed on the same level as the instrument.

3.4.2 Connection of Cleaning Liquid pipe

Remove the cleaning fluid pipe with the connector from the reagent packaging box. Connect
with the same color liquid port on the back panel of the host. Insert the other end of the pipe into the
cleaning solution bottle and tighten the cap. The cleaning fluid bottle must be placed on the same
level as the instrument.

3.4.3 Connection of the Waste Liquid Pipe

Remove the waste liquid pipe with the joint from the reagent packing box. Connect with the
liquid tube port of the same color on on the back panel of the host, and clockwise to screw the cap on
the waste liquid bottle. The position of the waste bottle should be at least 50cm below the plane of
the instrument.

3.4.4 Treatment of the Waste Liquid

The waste liquid is a mixture of stool samples and reagents. If placed for a long time, it will have strong
odor. Please dispose of it promptly. We recommend that the use unit strictly abide by the national and local
laws and regulations concerning the treatment of medical waste, and strictly follow the methods specified in
the relevant Medical Waste Disposal Regulations of the instrument user.

Warning
 In order to prevent the waste liquid from polluting the environment, it is
forbidden to pour the waste liquid directly into the sewer pipe. The waste
liquid must be discharged into the sewer pipe after biological or chemical
treatment. The hospital and the laboratory are obliged to comply with the
relevant regulations of the local government environmental protection
department.

12
 Attention
 The maintenance solution is used for strong cleaning, and is not connected to
the instrument through the pipeline.

Be careful
 After all the pipelines installed, the pipelines should be in a state of natural
relaxation, and it must not be twisted, folded or rotated.
 All pipe connectors are strictly prohibited from using any tools and can only
be installed by hand.
 If the reagent bottle is found to be damaged, leaked, or exceeding the shelf life
during installation, it cannot be connected. Please contact your local office or
supplier for replacement.

3.5 Connection of monitor, mouse, and keyboard

Connect the monitor to the instrument with a video cable;

Connect the monitor power cord;

Plug the mouse and keyboard into the instrument. If using a wireless keyboard and mouse,
plug the wireless receiver into the USB port on the instrument and install the driver.

3.6 Instrument host power cord connection

Plug the ending hole of the power cord into the mains power input, and plug the other end into a
grounded three-phase power outlet. Connect the grounding post of the rear panel of the main unit directly to
the grounding wire.

Be careful
 The power cord should be connected to a dedicated outlet.

3.7 Instrument start up

1) Turn on the UPS power switch (if available);

13
 2) Turn on the dedicated power switch connected to the host system;

3) Turn on the power of peripheral devices (printers, monitors, etc.);

4) Press the start button on the left side of the board, start the instrument, and enter the
operating system in a moment.

3.8 Printer Connection (Other Configuration)

1) Select the appropriate location to place the printer, we recommend placing it on the right
side of the instrument and keeping it at least 30cm away from the instrument.

2) Install the printer's accessories according to the operating instructions of the printer's
product manual.

3) Connect the plug of the print cable to the corresponding socket on the back panel of the
instrument and connect the other end to the printer.

4) Make sure the printer's power switch is off, plug one end of the power cord into the
“POWER” socket of the printer, and plug the other end of the power cord into the power
outlet.

5) Install the communication cable, see the printer's product manual for details.

6) Install the printing paper according to the operating instructions in the product manual.

7) Turn the power on for printer self-test.

Attention
 Verify the correctness of the printer's print function by running the self-test
program when installing the printer for the first time. You can also verify the
printer's print function by running this program during the future use of the
printer.

14
Chapter 4 Daily operation of the instrument

It is recommended that the operator read this section in detail so that the instrument can be
operated correctly.

4.1 Daily operation precautions

1) Ensure that the instrument is in compliance with the “Usage Environmental Conditions” listed in
1.4.3.

2) Check the reagents and waste container before starting the machine, and replace it in time.

3) Make sure the specimen collection cup is placed correctly.

4) When the instrument is in working condition, do not remove the specimen collection cup to
avoid injury or damage to the instrument.

5) Turn off the printer and monitor when you turn off the computer.

Be careful
 Do not shut down illegally to avoid data loss and cause instrument failure.

4.2 Starting
1) Check the waste container to determine if it needs to be replaced. Replace the waste
container if necessary

2) Check for reagents, if not, please replace reagents in time.

3) Check if the printer, monitor, mouse, and keyboard are reliably connected to the instrument.

4) Check if the printer is ready and has paper. For more information, please refer to the printer
manual.

5) Check if the power of the instrument is connected.

6) Check if the monitor's AC power cord is connected.

7) Press the start button .

15
 Figure 4-1 Login page

Attention
 The instrument will execute the cleaning command during the login process.
You can set whether to perform background detection and auto focus according
to 5.2.

Figure 4- 2 Main interface

16
4.3 Testing

4.3.1 General Operation Process

1) Turn on the instrument - turn on the instrument as described in 4.2.

2) Open the instrument operating software - double click on the computer desktop <KU-
F20> icon.

3) Login interface - enter <user name> and <password> as shown in Figure 4-1.

4) Place the sample - place the sample collection cup in the sample holder and place the
sample holder in the injection tray.

5) According to 6.1, set the colloidal gold item, the test reagent card in each colloidal gold
card position must be the same as the added item (for example, if the card No. 1 added
FOB, the No. 1 card can be placed in the FOB card).

6) Start detection - click <Start> and the instrument starts to detect.

7) Patient data records - Select the sample to be edited on the <Today> interface, enter the
data, and enter the patient data at any time.

8) Report review - after the test is completed, the sample results can be reviewed at any
time.

9) Report print - the reviewed sample information can be printed at any time.

10) Turn off the instrument - click <Exit>, the instrument will automatically shut down
the maintenance and exit the software, then shut down the computer.

Attention
 After the test is completed, take the sample holder out of the tray.
 The tested samples can be taken out detect for other items.
 If there is a sample being tested, please do not quit. If you quit, the instrument may
not work properly.

4.3.2 Detection Status Display

17
 Figure 4-3 Detection status display

During the detection process, the sample status being tested, the channel usage, the reagent status,
the colloidal gold card case, and the reaction status of each colloidal gold card can be detected. The
microscope and colloidal gold card case can be observed on the <Detect> interface at the same time.

4.4 Sample information

4.4.1 Sample new create and delete

The sample number is differentiated by date, and the sample number starts from ‘1’ by
default everyday.

 Manually create a new sample

You can create new sample information at any time before taking a sample test. Enter
the sample number below the <Sample Information> screen and check the colloidal gold item
for the test. Click <New> to quickly create a new sample, as shown in Figure 4-4. You can
also change the test item in the colloidal gold item list after creating a new sample. You can
select up to 5 items, as shown in Figure 4-5.

 Automatically create new samples

When testing, the instrument can automatically add samples, the sample number is
automatically accumulated, and the default colloidal gold test item is the item selected under
the <Sample> interface. If you enter a sample number in <New>, the sample number will be
accumulated starting from <Start Sample Number>. The default <start sample number> is
"0", and the system will automatically retrieve the sample number and number it.

 Sample barcode entry

The instrument can pre-scan the bar code to create a new sample through an external bar code, or
enter the sample bar code after creating a new sample.

 Delete the sample

The samples can be quickly deleted by clicking the <Delete> button.

18
 Figure 4-4 New

Figure 4-5 Colloidal gold Item

4.4.2 Sample information record and modification

Select the sample number on the <Sample > , you can enter the relevant information of the
sample on the left side, and then <Save>, as shown in Figure 4-6.

You can also edit sample information at any time during or after testing.

In the <Sample> , you can also see basic information such as the detection status of the
sample. Among these,

: indicates that the test has been completed or has been reviewed;

: indicates that the test has not been conducted;

: indicates that it is being tested;

19
 Figure 4-6 Edit

4.5 Review and Print

When the test is complete, you can conduct a sample review. When you select the sample you
want to review in the <Sample>, the information bar on the left will display the information and
physic results of the sample. In the results list on the right, you will see the microscopic and
colloidal gold results of the sample, as shown in Figure 4-7.

Figure 4-7 Result display

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4.5.1 Four-field combination review
Double-clicking the sample selected line will turn to the four-view combination review interface, as shown in
Figure 4-8.

Figure 4-8 Four view into one

In the four-view combination audit interface, the upper left corner is the patient information,
the lower left corner is the result of the physic index, the upper right corner is the microscopic
examination result, and the lower right corner is the colloidal gold result.

1) : Four-view combination switch button;

2) : Vision switch slider,

click the slider to locate to any group, below is the microscopic elements display;

Change categories .

4) Click the markable target, the right mouse button click "modify" can modify the target
category, or you can change the category by "modify into".

5) Right-click on the image and select “ Add ” . You can press Ctrl+left mouse button to
mark the target, or you can mark the required category by “Add as”.

6) The right mouse button can select or cancel display mark and magnifier.

21
 7) Switching between microscope A and microscope B during review;

8) Sample switching function button, audit

confirmation, review cancel function button;

9) Return to the function button, return to the sample information list.

10) Select Print Image----- Click the right mouse button on the diagram to select or take the
print image, and the selected image will display “P”. If the number of selected images
exceeds the maximum number of images printed, the default will only print the images
in front.

11) You can modify the results directly in the microscopic results, as shown in Figure 4-9.

Figure 4-9 Modify the results

12) After the review is completed, click <Review confirm> to complete the audit. In the sample
information list, the audit status will change to ‘√’. If you set the data output (refer to Section
6.3), the test result will be output.

Attention
 This interface can switch the level of the view image by scrolling the mouse
wheel.
4.5.2 Large-screen review
Double-clicking on one of the four-view combinations will take you to the large-screen review interface, and you
can review all views in the large-screen review interface, as shown in Figure 4-10.

22
 Figure 4-10 Large-screen review interface

1) : Return to the function button, click return to the four-view combination

review interface, or double-click on the image to return;

2) : Right mouse click save diagram and select target add.

Attention
 This interface can switch the level of the view image by scrolling the mouse
wheel.

4.5.3 Cancel the review

For the reviewed samples, you can click the <Review Cancel > function button to
cancel the review. It can be canceled in the <sample> interface/four-view combination audit
interface/large image review interface.

Attention
 The instrument cannot identify the abnormal part of the stool sample, and the

23
 sample collect must according to the clinical sample collection requirements.
 It is strongly recommended that the testing physician conduct a detailed
review of the sample prior to the report.

Attention
 No changes can be made to the reviewed sample.
 The 'low value' and 'high value' in the result list indicate the minimum and
maximum total number of components in all the group diagrams in the sample.

4.5.4 Quick review

Click <review Confirm> on the <Sample> interface to perform quick review and cancel
review. This operation supports multiple selection.

4.5.5 Print

You can print the results of the samples that have already been reviewed. Select the sample to
be printed on the <Sample> interface and click <Print>. You can also click <Print Preview>
to preview the report.

The instrument supports multiple report formats. You can select the format of the report in
<Setting>, see section 6.2.

4.5.6 Send
It is used to send test results to other terminal devices, such as LIS, HIS server. Select the record in
the <Sample> screen, and then click <Send>.

Please refer to Section 6.4 for setting of send.

4.6 Emergency

1) Pull out the emergency room and put it into the emergency sample;

2) Push into the emergency room;

3) Click <Emergency>;

4) Enter the emergency sample number;

5) Enter the sample barcode number if necessary;

6) The emergency sample number defaults from ‘1000’;

7) After the emergency sample is tested, take out the emergency sample;

24
 Figure 4-11 Emergency

Attention
 Emergency sample shows green ;

Figure 4-12 Green color shows emergency sample

 When the sample is not pushed into place, the alarm will be as shown in the figure. After
confirming the return to the position, click <OK>, as shown in Figure 4-12.

Figure 4-13 The alarm when the sample is not pushed into place

 If a sample is being detected in the counting channel, it will wait for its detection and clean the
channel, and then start detecting the emergency sample. If there is no sample in the channel, the
emergency sample will be detected immediately.

25
 4.7 Sample retest

1) Pull out the emergency room and put in the retest sample;

2) Push into the emergency room;

3) Select the sample to be re-inspect in <Sample > - Right-click to select with diluting and
without diluting retest;

4) After the emergency sample is tested, take the re-inspect sample;

Figure 4-14 With Diluting retest / without diluting retest

Attention
 The background of the re-inspect sample shows orange;

Figure 4-15 Orange shows re-test sample

26
 4.8 Querying Historical Data
In the <Sample> interface, you can query the information of all samples. You can query by
inspection date and the number of samples queried.

Click on the sample you want to view, the information and results for that sample will be
displayed in the sample information bar and results bar. At the same time, sample information can be
entered, modified, reviewed, and printed.

Figure 4-16 Conditional query

4.9 Diagram
On the <Diagram> interface, as shown in Figure 4-17, you can see the various constituents
commonly found in stool samples. At the same time, diagram can be made for learning and research. The
default diagram of the instrument when it leaves the factory can not be modified or deleted, the operator's
diagram can be edited or deleted.

Figure 4-17 Diagram

4.9 Quality Controls

4.10.1 Control information edit

27
 Click<Setting>→<Quality Controls> into controls information edit interface.

Figure 4-18 Quality controls information edit

Add/Delete/modify/clear controls information

4.10.2 Controls information query

Main interface→<QC Query> inter controls information query interface.

Figure 4-19 Controls information query

1）Click <Latest>quick display the latest new add control information, can also query controls information by date.

2）Select quality controls→<New>New create the control samples waiting to be test.New create number shall begin
from 10001.

28
 Figure 4-20 New add sample controls

Figuer 4-21 controls list waiting to be tested

3）Select date, controls type to click <Quality control >，Query the history control result.

4）Click sample controls in sample list, The left side of main interface will display control information.

Figure 4-22 Control information display

Attention

If delete the controls information, it’s information will be “Empty”, Don’t delete if want to tracking information.
Will show as follow image.

29
 Figure 4-23 Display after information delete

4.10.3 Controls automatic operation

1) Quality controls preparation

Figure 4-24 Quality controls bottle

The feces analyzer uses a quality control, the colloidal gold part is used in a 3mL or 5mL bottle; the formed element
(red blood cells, white blood cells) is used in a 5mL bottle. The quality controls shall prevail.
2) Prepare the bottle sleeves that are compatible with the quality control packaging

Figure 4-25 Bottle sleeves

30
 The bottle sleeves can put onto tube rack.

Figure 4-26 The quality control bottle sleeves placement

3) New create waited control sample

According to 4.10.1 adding controls information, according 4.10.2 create control sample.
4) Quality controls placement
After pre-diluting and mixing of the quality control according to the manual, the waited quality control items are
placed on the test tube rack in the order of the new quality control samples. For example, the new 10001 fecal occult
blood low value L, 10002 fecal occult blood high value H two quality control samples, then the 1st and 2nd quality
control samples placed on the test tube rack are the fecal occult blood low value L, fecal occult blood high Value H.

Figure 4-27 Controls automatic operation

5) Quality control detect

Click <Quality Control> on the interface,The instrument will complete the quality control detection.

Attention
forbidden to place the QC sample and click the <Start> button.

31
 Chapter 5 Maintenance

To ensure that the instrument is in good working condition for a long time, reduce the
frequency of instrument failure, and prolong the service life of the instrument, careful daily
maintenance and regular maintenance must be performed on the instrument. This chapter describes
how to maintain the instrument and its steps.

5.1 Focus
Click <Maintain>→<Focus> to enter the focusing interface.

Figure 5-1 Focusing interface

5.1.1 Focus

Can be done by autofocus or manual focus.

5.1.1.1 Autofocus

1) Click to start focusing, after the <success> is prompted, you can perform other operations.

2) Select the auto focus on the boot, and each time you log in the software, the auto focus will
be performed.

5.1.1.2 Manual focus

1) Prepare about 8-10 mL of red blood cell suspension using 2:1000 uL (blood: diluent) in the
sample collection cup.

2) The specimen collection cup containing the red blood cell suspension is placed in the

32
 emergency room.

3) Click <Maintain> → <Focus> → <channel 1 loading>, <channel 2 loading>,<channel 3

loading>

4) After the erythrocyte sedimentation is stable (about 70 seconds), check the video interface to
see if the red blood cells are clear, and the red blood cell image needs to be adjusted as shown
in Figure 5-2, such as a round cake.

5) Select the focus channel.

6) Click < > or < > to adjust focus length until it is clear 。 <Step distance> is the
number of steps taken to adjust the focal length each time. It is recommended to set it to 10.

7) Close the <Maintain> window and the instrument will automatically clean the channel.

Figure 5-2 Clear red blood cell image

5.1.1.2 Wipe the counting chamber

When the surface of the counting chamber is stained, it needs to be wiped. Click <Counting
chamber Wipe>, the objective lens will go to the wipe position, then use the cotton swab to wipe
the stain on the surface of the counting chamber, close the maintenance window, and the objective
lens will be automatically reset.

Attention
 It is recommended to focus at least once a week, and instantly focus
when the image is not clear.

33
 5.2 Shooting parameters
Click <Maintain>→<Shooting Parameters> to enter the shooting parameter interface.

Figure 5-3 Shooting parameter settings

5.2.1 Channel selection

Select the counting channel to be used, select to indicate use.

5.2.2 Background detection

When shooting a picture, the stain affects the result, and the background detection detects if
there is a stain in the field of view. Check <Background Detect> to automatically perform
background detection when booting.

Click <Background Detect> to perform a background shot and judge if the prompt 'Channel
is dirty' is executed according to 5.1.1.3.

5.2.3 View filed

You can select the number of pictures to be taken according to actual needs, and you can select
8/8, 16/16, 32/24,40/40,64/64 and 80, 96. The first number indicates the number of high
magnification A, and the second number indicates the number of high magnification B. You can
also choose self-definite, enter the number of groups you want to take, and each group contains 4
photos.

34
5.2.4 GIC auxiliary recognition

Select to indicate the use of the auxiliary recognition function, which is to automatically
interpret the results of the captured colloidal gold items.

5.2.5 Microscopic screening

Select to indicate that the microscopic sample is screened.

5.3 Reagents
Click <Maintain>→<Reagent> to enter the reagent parameter interface.

Figure 5-4 Reagent

35
 5.3.1 Pipeline maintenance

 Cleaning solution cleaning

Click <cleaning solution clean> and the cleaning solution will be used to clean the channel.

 Maintenance

When there are many stains in the view, it is difficult to eliminate by the cleaning, and
the channel maintenance operation can be performed.

Operation steps:

1) Pour the maintenance solution into a clean sample collection cup.

2) Put the specimen collection cup containing the maintenance solution into the
emergency room.

3) Click <Maintain>.

4) Let stand for about 5 minutes.

5) Cleaning channel----- After the channel maintenance is completed, close the system
setting window and the instrument will automatically clean the channel.

 Drainage

Before transporting or when not in use, unscrew the reagent line (excluding the waste line),
click <Drainage>, the instrument will discharge the reagents in the line unit out of the
machine.

 Perfuse

The instrument has a reagent alarm device. When there is no reagent or there are air bubbles
in the pipeline, the instrument buzzer will sound. Please perform reagent perfusion.

 Reading reagent volume

The instrument has a reagent card alarm device. When the reagent card reading is low,the
instrument will display the <Replace reagent card> prompt. At this time, please replace the
diluent reagent bottle and reagent card, and click <reagent amount read >.

 Waste liquid alarm

When the waste bottle is full, if the waste alarm function is on, the instrument will beep.

 Exhaust

In order to ensure a good working environment, an exhaust fan is arranged at the rear of
the instrument. When necessary, the exhaust fan can be turned on, and the exhaust gas is
exhausted through the fan .

Attention
 If the exhaust fan is not connected, do not open the exhaust function,
otherwise the exhaust fan may be damaged.

36
 5.3.2 Dilute and mix

 Diluent volume setting

The instrument can set the amount of dilution added during sample dilution. The amount
of dilution must be between 5.0-10mL.

 Mixture time setting

The instrument can set the sample mixing time, the mixing time must be no less than 5
seconds.

5.4 Record
Record the errors and prompts that occur when the instrument is running, which is convenient
for instrument maintenance and timely handling of faults.

Figure 5-5 Record

5.5 Daily maintenance of the instrument

According to the maintenance requirement of the instrument during use, we divide the preventive
maintenance schedule of the instrument into daily, weekly, quarterly and annual routine
maintenance and targeted maintenance according to actual needs.

37
 Be careful
 If the unit or organization using the instrument does not implement a
standardized maintenance plan, it will cause the instrument to fail.

Warning
 The operator must wear clean gloves during maintenance.

5.5.1 Daily maintenance

 Channel cleaning

The instrument will automatically fill and clean each time it is turned on, and it can be
cleaned as many times as needed.

 Maintenance

After the instrument finishes working, the channel maintenance will be performed when the
machine is turned off. If the instrument is not shut down or shut down illegally, the
instrument will not be maintained.

5.5.2 Weekly maintenance

 Microscope focusing is conducted once a week;

 Clean the surface stains of the instrument every week, especially the sampling position
and the stains that may remain around the sampling needle, to prevent mildew and
pollution;

 Dedusting the surface of the counting chamber every week.

Be careful
 Do not use corrosive acids, bases and strong volatile organic solvents
such as acetone, ether, chloroform, etc. to scrub the surface of the
instrument. Only neutral detergents can be used.

5.5.3 Quarterly maintenance

Perform a dust removal inside the instrument every quarter.

5.5.4 Annual maintenance

Good maintenance every year is necessary to maintain the optimal working condition of the

38
 instrument and extend the service life of the instrument. Due to the high requirements for annual
maintenance work, it should be carried out by engineers that authorized by the company. Please
contact the company before maintenance every year.

5.6 Instrument maintenance

5.6.1 Instrument cleaning

The surface of the instrument should be periodically scrubbed with a soft cloth.
After cleaning, the instrument must be dried.

Attention
 Do not scrub with chemicals and organic solutions. The dust in the gap can
be removed with a wet cotton swab.

5.6.2 Protect the users

The instrument is designed to be safe and provides three levels of protection to ensure safety
in the event of a breakdown. First, the software sets the normal working range. Secondly the
circuit design ensures that it does not exceed the value. Finally, the fuse will cut off the power.
The instrument is designed to operate reliably.

5.6.3 Protect the instrument

Do not switch the instrument frequently. The interval between the two switches should
exceed 30 seconds.

Do not turn off the power immediately after the test is completed, let the fan continue to work
for five minutes before shutting down. The instrument is equipped with a 2A fuse to protect
the instrument.

5.6.4 Replacing the fuse

When the fuse is damaged, the user can replace the fuse as follows: use a flat-blade
screwdriver to open the fuse box cover, replace the fuse (fuse type F2AL250V), and then fuse the
fuse box.

Be careful
 Be careful of electric shock

39
 Chapter 6 Settings

6.1 Colloidal Gold Card Settings

Figure 6-1 Colloidal gold card settings

The instrument can be compatible with a variety of colloidal gold reagent cards, and can be
added with different types of colloidal gold reagent cards. Since the size of each colloidal gold
detection card may be inconsistent, the relevant size must be filled in when adding new reagents.

 Users can add items such as fecal occult blood, rotavirus, adenovirus, Helicobacter
pylori, etc.

 Select the colloidal gold item to click on the from No. 1 to No. 5 card box to
start up the colloidal gold item. After starting up, you need to put the corresponding card
in the related box.

 Click to avoid starting up the project.

40
6.2 Report settings

Figure 6-2 Printing settings

Set the instrument's report form

 Auto print - Enable automatic printing, automatically print the report after each review.

 Print default picture - the default picture will be automatically selected for printing when
the review is confirmed.

 Report title - used to set the title of the report, for example: Feces analysis report.

 Remark - used to set the remarks column in the report.

 Report form - select report format.

 Set margins.

41
 6.3 Communication Settings

Figure 6-3 Communication Settings

 Sample delivery port: used to set the pre-processing communication port of the instrument sample.

 Microscopic port: used to set the instrument microscope communication port.

 Data output: Click <COM output> in the data output, and after setting the port number and
baud rate correctly in the serial output, the data will be output through the serial port. Click
<Network port output> to set the IP address and port of the network server. The data will
be output through the network port. If you want to transfer pictures, please click <picture>,
the selected print picture data will be output together.

 Automatic output: click the automatic output, the output will be output when each sample
review is completed.

 Built-in barcode: If you choose the built-in barcode, when the built-in barcode is selected,
the barcode of the sample will be automatically read and saved during the sample delivery
process. Standard instrument configuration does not have barcode.

 Barcode port: setting for the built-in bar code port.

6.4 The connection of LIS system

The interface between the instrument and the LIS system is based on HL7version 2.3.1, which
supports one-way or duplex communication. The LIS server can receive test data from the feces
analyzer or send sample application information to the feces analyzer. See the LIS Protocol Interface
Manual for detailed interface description.

To facilitate connection to the LIS system, the instrument can be connected to the LIS server
using the serial communication protocol or the TCP/IP communication protocol.

42
6.4.1 Serial port (RS232)
1) Use serial port crossover connection, set the parameters as follows.

The port number Com1 Defaults to Com 1 and can be set

The baud rate 19200 Defaults to 19200 and can be set

Databits 8 Default setting and cannot be changed

Parity none Default setting and cannot be changed

Stopbits 1 Default setting and cannot be changed

2) Operation steps

a) Connect the instrument and LIS server using a serial cable

b) Open the instrument software control program

c) Click <setting>

d) Select <Communication> interface

e) Check <Auto Output>

f) Select < COM Output>

g) Set the output port and baud rate of the instrument in the serial output. Be careful not to
conflict with other ports.

Note: Due to speed limit of the serial port output, the default serial port output does not send pictures.

6.4.2 TCP/IP
1) Operation steps

a) Connect the RJ45 interface and LIS server of the instrument with a network cable

b) Open the instrument software control program

c) Click <Setting>

d) Select <Communication> interface

e) Check <Auto Output>

f) Select <Internet Output>

g) Set the IP address and port of the LIS server in the network port output. Note that the server
and client ports must be the same.

6.4.3 Sending the results

After checking <Auto Send> in the setting interface, click <Review Confirmation>
under the sample list or < Confirmation> under the audit interface to automatically send the
result. You can also send the results manually via <Send>.

43
 Attention
 The sample application information sent by the LIS server only supports the
setting of the colloidal gold detection item. The microscopic inspection item
can only be set by the instrument.
 In duplex communication, the serial number of the colloidal gold item is 1, 2,
3... from top to bottom in the order of the list of colloidal gold items as shown
in Figure 6-1.
 When the feces analyzer is set to one-way, the instrument will only send the
detection results and ignore any Lis system messages received.

Figure 6-4 Microscopic inspection project setting interface

44
 6.5 Project setting
Click <Setting>→<Microscopy Item> to enter the microscopic inspection item setting interface.
v

Figure 6-5 Microscopy inspection project setting interface

 The instrument can freely set the detection items, including adding, modifying, and
deleting. When you want to starting up an item, check <On> and the item will be
detected during the microscopy. Click <Save> to save your updates.

 Gradient value setting: Each item can be set to '+', '++', '+++', '++++' 4 gradient values,
when the project's microscopic maximum value is lower than '+', the project results will be
reported in xx-xx/HP or xx-xx/LP, otherwise the maximum value will be higher than the
value of a certain file, and the result of the project will be reported as '+' or '++' or '+++' or
'++++'.

 Negative: You can set the expression in the list when the result of the item is negative.

 Positive: You can set the expression in the list when the result of the item is positive.

 Color: You can set the color of the item in the list. The reminder and mark of the item are
all in this color.

45
 Chapter 7 User Management

Used for the management of operators, inspection departments, and inspection physicians.

7.1 Operator Management

Username - the name you need to log in.

Physician's name - operator name.

User Group - The system is set up with 2 user groups including "System Administrator" and
"Ordinary User". System administrators can use all functions, ordinary users cannot make system
settings, have no permissions to add/delete users.

 System administrators can add, modify, and delete users.

 Ordinary users can modify their passwords.

Figure 7-1 User list

7.2 Inspection doctor management

You can add and delete commonly used inspection departments and inspection doctors.

46
 Figure 7-2 The inspection doctor

7.3 Logout
Click <Logout> to switch users.

47
 Chapter 8 Troubleshooting

This section gives a list of common faults and treatment methods for the instrument. When
the instrument fails, the operator can find the cause of the fault based on the alarm message sent
by the instrument.

If the user still cannot solve the problem according to this method or needs more technical
support from Zhuhai Keyu Biological Engineering Co. ,Ltd., please call us.

8.1 Troubleshooting Guide

The troubleshooting guide is designed to assist the user in finding and troubleshooting faults
that occur during operation of the instrument. To accurately and quickly find and troubleshoot,
firstly read through this manual and understand the normal operation and preventive maintenance
of the instrument.

In general, the troubleshooting should be carried out in the following three steps:

Step 1: fault confirmation

The operator should be able to confirm the cause of the fault, and the fault can be corrected only
by confirming the fault correctly.

Step 2: fault classification

The fault classification of the instrument can be roughly classified into the following three
categories:

1. Hardware related failures.

2. Software related failures.

3. Test failures related to sample analysis.

The hardware and software related faults can only be repaired by Zhuhai Keyu Biological
Engineering Co. ,Ltd. or by qualified engineers authorized by Zhuhai Keyu Biological Engineering
Co. ,Ltd., and the test failures related to sample analysis can be excluded by the operator under the
guidance of engineers from Zhuhai Keyu Biological Engineering Co. ,Ltd..

Step 3: troubleshooting

The maintenance engineer takes the appropriate method to troubleshoot. If the operator is able to
troubleshoot by himself or with the help of engineers from Zhuhai Keyu Biological Engineering
Co. ,Ltd., the time spent on the delay will be greatly reduced.

8.2 Seeking technical support

If the instrument needs to go to Zhuhai Keyu Biological Engineering Co. ,Ltd. for technical
support, please call the after-sales service department of Zhuhai Keyu Biological Engineering
Co. ,Ltd., contact us by phone or fax to see the copyright and statement. Users must provide detailed
and clear problem descriptions and related information when seeking technical support, as follows:

1. Model of the instrument.

2. The body number of the instrument.

48
 3. Detailed and clear description of the fault phenomenon and operating environment (such as the
actions under which window and state, etc.).

4. Data and reports related to the failure.

8.3 Handling precautions for stopping the equipment due to repairing or handling

When the instrument stopped due to maintenance or equipment handling, the user should
perform the following steps:

1. Remove all unused specimen collection cups and gold standard cards.

2. Specimens in the specimen collection cup that are not used shall be manually tested in
accordance with hospital regulations.

3. The un-used gold standard card should be sealed storage.

4. Dispose all used specimen collection cups, waste gold standard cards and waste liquids in
accordance with local laws and regulations on medical waste disposal regulations.

5. Store the cleaning solution and diluent, etc. according to the storage requirements in the
relevant instructions.

The above treatment steps have been able to achieve minimal control of biological hazards
and will not cause biological hazards during transportation or handling.

If the instrument needs to be returned to the manufacturer, after following the above steps,
please use the original packaging to package the instrument and return it to the manufacturer
through logistics.

8.4 The failure of computer operating system and hardware

No. Fault phenomenon Possible reason Approach

1 Instrument cannot be 1) Unplugged 1) Test instrument power cord

turned on

2 The computer cannot 1) Memory failure 1) Replace the memory module

enter the system
2) Hardware failure 2) Check for bad sectors. If there are
bad sectors, repair the bad sectors firstly;
if it cannot be repaired, please replace
the hard disk and copy the data to the
new hard disk.

3 Computer crash 1) Hardware failure 1) Refer to No. 2 for troubleshooting

2) USB interface failure 2) Pull out the Plug and Play device in
the USB and restart the computer
3) Infected with virus
3) Upgrade the anti-virus software,
check the virus, if it still can't be
solved, please re-install or restore the
operating system.

49
 4 The computer is running 1) Infected with virus 1) Upgrade the anti-virus software,
slowly check the virus, if it still can't be
2) Camera connection solved, please re-install or restore the
is interrupted operating system.

2) Check the connection

8.5 The failure of instrument application part

No. Fault phenomenon Possible reason Approach

1 Image is not clear 1）The microscope focal 1）Adjust the microscope focal length
length is not adjusted
well

2 Detection process stops 1）Reagent used up 1）Replace reagents and reagent cards

3 Reagent alarm 1）No reagent in the 1）Replace reagents and perfuse

pipeline

4 Camera initialization 1) Camera data cable is 1）Replace the data cable

fails invalid
2) Reinstall the camera driver
2) Camera drive failure

5 The motor is not reset 1）Motor reset sensor 1）Replace sensor

when the power is on failure

6 After sampling, the 1）Invalid solenoid 1）Replace the solenoid valve

sample in the counting valve at both ends of the
chamber cannot be counting chamber
stationary for a long
time.

50
Chapter 9 Prevention, limitation and harm

Any improper use of the instrument will not achieve the desired results, and may even cause
some harm to the operator or others. Therefore, before operating and using the instrument, it is
necessary to standardize the use of the rules, improve the conditions of use, prevent the occurrence of
hazards, and achieve the best use of the instrument.

9.1 Restrictions on use

1） KU series feces analyzer is limited within vitro diagnostic reference analysis.

2） Anyone who uses, moves, installs, or maintains must read this manual carefully and follow
the instructions in this manual. Failure to do so may result in an accident and loss of our company's
free warranty.

3） Repairs with any reason should be approved by the company. Any parts replacement should
use the parts specified by the company, otherwise it may cause an accident and lose the company's
free warranty.

4） Regular maintenance without following the maintenance procedures in Chapter 5,

“Instrument Maintenance” of this manual will affect the measurement and analysis results of the
instrument, reduce the service life of the instrument, and may cause an accident. At the same time, it
will also lose the company's free warranty opportunity.

9.2 Installation restrictions

1) The first installation must be completed by a qualified engineer authorized by the company.

2) The instrument must be placed on a level, stable work surface, avoid direct sunlight, avoid
overcold and overheated exhaust vents, be away from dryers, centrifuges, X-ray equipment, copiers
and ultrasonic cleaners.

3) The reagent should be placed at the same height as the instrument or kept in the same plane.

4) In order to maintain good ventilation, a certain amount of space must be reserved around the
analyzer. Keep the instrument at least 40cm away from surrounding objects for ventilation. The
mounting table should be flat and free of vibration, and the size should be at least 1500mm×800mm.
There should be enough space around the instrument for maintenance and repair.

5) Before the instrument’s first run, make sure that the fluid connection of each reagent bottle is
correct and reliable. Whether the external conduit is bent or not, to hinder the smooth flow of liquid.
Whether the waste liquid is discharged into a suitable container.

6) It is strictly forbidden to plug or unplug any electrical connectors of the instrument when the
instrument is powered on. In order to prevent power interference and secure user safety, please
confirm that the grounding wire of the instrument case is well grounded before use.

51
 Warning
 Any personnel who are not authorized or qualified to repair the instrument
shall not open the screws or door locks on the instrument casing at any time,
otherwise all problems will be borne by the user！

9.3 Personal protection and infection control

1) Users must comply with laboratory or clinical inspection requirements during sample testing
and routine maintenance. Wear medical gloves and safety glasses to avoid direct contact between the
skin and the measurement sample.

2) Since all clinical samples may contain human feces and are potentially contagious, these
items must be handled in accordance with established laboratory or clinical procedures, wear overalls,
and wear medical gloves and safety glasses. In the work area, you can't smoke, eat, and can't use your
mouth to blow and suck the working pipeline.

3) Because the waste liquid produced by the fecal sample and the instrument contains potential
pollutants, it may have biological and chemical hazards, and special care should be taken during the
treatment. It must comply with local government regulations when cleaning, handling, and
discharging.

4) Do not pour the unused reagent into a new reagent tank (bottle) to prevent contamination of
new reagents.

The reagents should be stored in accordance with the instructions for use. Users of this
instrument are obliged to establish and maintain effective custody and remedial measures to prevent
the expiration, deterioration, misuse, and ingestion of reagents, calibration materials, and quality
control materials. Reagent storage should avoid strong cold and hot environment.

9.4 Toxic and harmful substances in products and their contents

Harmful
Part Name substances

Cr^6+ PBB PBDE

Pb Hg Cd

Printed circuit ○ ○ ○ ○ ○ ○
board assembly

Polymer ○ ○ ○ ○ ○ ○

Metal ○ ○ ○ ○ ○ ○

○ : Indicates that the content of this toxic and hazardous substance in all homogeneous materials
52
of this part meets the limit requirements specified in SJ/T 11363-2006.

×: Indicates that the content of this toxic or hazardous substance in a homogeneous material of
the part exceeds the limit requirement of SJ/T 11363-2006.

9.5 Electromagnetic compatibility

Attention:

 The KU-F20 Feces analyzer meets the emission and immunity requirements specified in this
part of GB/T 18268.1 and GB/T 18268.26, see the table below.

 The user is responsible for ensuring that the equipment is in an electromagnetic compatibility
environment so that the equipment can work normally.

 It is recommended to evaluate the electromagnetic environment before the equipment is used.

Warning:
 The KU-F20 feces analyzer is designed and tested in accordance with Class A equipment in
GB 4824. In a domestic environment, this equipment may cause radio interference, and
protective measures may be required.

 Do not use the device near strong radiation sources (such as unshielded RF sources), as this
may interfere with normal operation of the device.

53
 Table 1:

Electromagnetic
emission

Emission Compliance
test

GB 4824

Conducted emission

GB 4824 Group 1
Class A
Radiation emission

GB 17625.1
Not applicable
Harmonic emission

GB 17625.2
Not applicable
Voltage fluctuation / flicker emission

54
 Table 2:

Electromagnetic
immunity

Compliance with
Immunity test Basic Test performance
item standard value criteria

Contact discharge: ±2kV、±4kV

ESD GB/T B
17626.2 Air discharge: ±2kV、±4kV、±8kV

Radio frequency GB/T 3V/m, 80MHz～2.0GHz, 80%AM A

electromagnetic 17626.3
field

Pulse group GB/T Power cable: ±1kV(5/50ns,5kHz) B

17626.4

Line to ground: ±2kV

Surge GB/T B
17626.5 Line to line: ±1kV

Radio frequency GB/T Power cable: 3V/m, 150kHz～80MHz, A

conduction 17626.6 80%AM

Power frequency GB/T 3A/m, 50/60Hz A

magnetic field 17626.8

1 cycle 0%； B
Voltage dip, 5 cycle 40%； C
interruption
GB/T C
25 cycle 70%；
17626.11
C
250 cycle 5%

Performance discrimination:

A. During the test, within the specification limits means normal performance.

B. During the test, temporarily reduced or lost function or performance, but self-recovery.

C. During the test, temporarily reduced or lost function or performance, but requires operator intervention or
system reset

55
 Appendix 1:Accessories
No. Description Ge.Quantity Unit

1 KU-F20 Feces Analyzer host 1 Set

2 Monitor 1 Set

3 Mouse with cable 1 Set

KU-F20 Feces Analyzer manual 1 pcs

Feces Analyzer certification 1 pcs

Feces Analyzer warranty 1 pcs

4
Zhuhai Keyu Biological Engineering Co. ,Ltd 1 pcs
qualification information

5 Specimen collection steps 1 pcs

6 Operation procedures of Feces Analyzer 2 pcs

7 Maintenance procedures of Feces Analyzer 2 pcs

Power cable 1 pcs

8
Ground wire 1 pcs

Sample diluent pipe 1 pcs

Cleaning solution pipe 1 pcs

9 Waste liquid pipe 1 pcs

Waste alarm device 1 set

10 Exhaust pipe with joint 1 pcs

11 Test tube rack 10 pcs

Colloidal gold card box (universal type) 5 pcs

12
Transparent crisper 1 pcs

Key 1 pcs

56
 Dongle 1 pcs

Mouse pad 1 pcs

13
Cotton swab 1 pack

Business card holder 1 pcs

14 Sample diluent 5L 1 bottle

15 Cleaning solution500mL 1 bottle

16 Concentrated cleaning solution 100mL 1 bottle

17 5L Waste barrel 1 pcs

18 Specimen collection cup 100 pcs

19 Fecal occult blood test kit (20 test/box) 2 kit

20 waste card collection box 1 pcs

21 Activated carbon 1 pack

22 Barcode scanner (Free) 1 set

23 FOB Quality controls 2 Group

24 TF Quality controls 2 Group

25 Colloidal gold card box(30Test) 5 pcs

Note: The list when packing with the instrument shall prevail.

57
Appendix 2: Symbol

Attention Biological Check the

electric hazard
hazard instructions for Manufac-turer
use

Protective
Turn off (power)
grounding Serial number
Turn on (power) Fuse

Thorny
Environmental Burns Temper-ature
In vitro diagnostic protection period Attention limit
medical device Attention

Fragile substance
Up Dry
Serial port Network port

～ Stacking layer
limit
AC USB interface Keyboa-rd
No rollover
interface

58
59
Feces Sample Collection Cup Instruction
【Product Name】
Feces sample collection cup
【Specification】
Rare spoon I, rubber seal II, rubber seal III
【Package】
1000 pcs/Carton
【Intended Use】
For clinical feces sample collection.
【Applicable Instrument】
Applicable for KU-F20 Feces Analyzer from Zhuhai Keyu Biological Engineering
Co.,Ltd.
【Main Component】
Cup, lid, filter
【Cup Figure】

Rare spoon I Rubber seal II Rubber seal III

【Instruction Principle】
The two filters divide the specimen collection cup into three chambers, a mixing chamber,
sampling chamber and water filtering chamber. The filter between the mixing chamber
and sampling chamber is a coarse mesh, which effectively filters the residue of the
specimen. The filter between the sampling chamber and the water filtering chamber is a
fine filter that can filter the moisture of the fecal diluent.
【Characters Performance】
1.Appearance： The cup body is colorless and transparent, and the surface is free from
scratches and bruises. no dust spots and no leakage;
2.Size：63×40.5×23mm

【Operation】
Feces Sample Collection Cup Instruction
1. Stick barcode on the cup (based on user's needs).
2. Open the lid of the specimen collection cup and collect the feces specimen with a
spoon attached to the lid of the specimen to sample the mucus, pus and black parts.
3. Take a flat spoon for soft feces, 3 spoons for thin water feces, and one-third spoon
for black feces and bloody feces.
4. Put the specimen spoon onto cup body and tighten the lip.
5. Put the collection cup into the sample rack, detect by instrument follow the
instruction.

【Precaution】
1. The sample collection cup operate under the correct guidance of medical staff.
2. Don’t use if the specimen collection cup has obvious deformation, cracks and foreign
matter or sediment in the cup.
3. One-time use and should be placed in a dedicated collection box after use.
4. During the process of sample collection, sample analysis and sample transfer, medical
personnel should wear protective tools such as gloves to prevent pollution.
5. After specimen is collected, the specimen collection cup should be kept up.
6. Please do not use the specimen collection cup that beyond the expiration date.
【Storage and validity date】
1. The storage environment should in a clean room with a relative humidity no more
than 80%, temperature at -10 to 35 ° C, no corrosive gas and good ventilation.
2. Do not hit the extrusion during transportation to avoid rupture,do not expose to the sun to
avoid deformation .
3. The expiry date should be three years.(Details please see package)

【Company Information】
Zhuhai Keyu Biological Engineering Co.LTD
Add:2FD building No.288 airport east road Sanzao town Jinwan district Zhuhai city
Guangdong provicnce China.
Website: en.keyubio.com Email:export@keyubio.com
Tel: 0756-6821168 Fex:0756-6821169

Version No.： A/1 Edit date：19th July, 2019

Reagent pack for Feces Sample Instruction
【Product Name】 【Sample Requirement】
Reagent pack for Feces Sample Fresh Feces
【Package Specification】 【Instruction】
Model Specification According to the feces sample reagent pack for Feces

KU-R04-1 Sample diluent：5L*1，Cleaning analyzer instruction.

solution：50mL*1 【Limitation】

Sample diluent：10L*1，Cleaning It must be used in supporting with the applicable model. For
KU-R04-2
abnormal or questionable inspection results, it must be
solution：50mL*1
manually re-examined.
【Intend Use】
【Characters Performance】
The sample diluent is used for dilution and liquefaction of
the sample to be tested, so that sample can be tested with the Item Sample diluent Cleaning solution

instrument. It is not directly involved in testing. pH 7.0±0.50 13.0±0.50

Cleaning solution: used for cleaning the liquid system of the Blank count 0/μL 0/μL
feces analyzer.
Red blood
【Principle】
cell
The sample diluent is an isotonic solution to maintain cell Keep at least 1 hour
morphology
morphology; the cleaning solution contains sodium
observation
hypochlorite, which has strong oxidizing properties and can
【Precaution】
be deeply cleaned.
1. For in vitro diagnostic only, Don’t taken orally.
【Main Component】
2. If the vibration occurs due to transportation or other
Name Main Component
reasons before use, it should be allowed to stand for 20
Sample Sodium chloride; sodium sulfate; minutes to be stabilized before use, otherwise it may be
diluent phosphate; disodium edetate; preservative counted due to bubble interference.
3. Can not be in contact with eyes and skin. If it is
Clean
Sodium hypochlorite accidentally contaminated, rinse it off with water
Solution
immediately.
【Storage and invalid date】
4. Read the instructions carefully before use, use within
1. Reagents should be stored at 2 ° C ~ 40 ° C, dry and
the validity period, and do personal hygiene protection.
ventilated environment to avoid direct sunlight.
5. After the reagent is unsealed, it should not be exposed
2. Under the storage conditions, the sample diluent and
to the air for a long time to avoid affecting performance
cleaning solution valid for 12 months if not open, valid for
index. Therefore, after the reagent is opened, please
60 days after opening. It is recommended to use up within
tighten the cap on the instrument pipe.
60 days after opening.
6. Dispose of waste according to the requirements of the
【Applicable Instrument】
hospital or environmental protection department after
Item Instrument Applicable
use.
KU-R04- KU-F20 Feces Analyzer
1
KU-R04- KU-F20 Feces Analyzer
2 1
【Symbol Explanation】

In-vitro diagnostic Temperature limit

Avoid sunlight Manufacture date

LOT Number See instructions

Expiry date Biological Danger

【Literature Reference】
GB/T 191-2008 packaging storage and transportation
symbols
YY/T 0466.1-2009 Medical devices - Symbols for labeling,
marking and providing information for medical devices -
Part 1: General requirements
Guidelines for the preparation of instructions for in vitro
diagnostic reagents (State Food and Drug Administration
2014.9.11)
【Company Information】

Zhuhai Keyu Biological Engineering Co.LTD

Add: 2FD building No.288 airport east

road Sanzao town Jinwan district Zhuhai city
Guangdong provicnce China.

Website: en.keyubio.com Email:export@keyubio.com

Tel: 0756-6821168 Fex:0756-6821169

【Approval Date】
19th, April, 2017