Liquid-based Cytology Smear Processor Instructions for Use

Lituo Biotech

LT-YJ2000
Liquid-based Cytology Smear

Processor Instruction for Use

 Liquid-based Cytology Smear Instructions for

Preface
Thank you for using Liquid-based Smear Processor LT-YJ2000. For your correct
operation, we attached the Instructions for Use. Please be sure to review and understand the
information in this Instruction for Use before installing and using the instrument. If any queries,
please contact us.
The instrument is subject to modifications and upgrading to improve its performance,
which may incur the discrepancies between Instructions for Use and instrument itself. For this
kind of situation we will modify the information in Instructions for Use accordingly as soon as
we can.

Declaration
All rights of Instruction for Use are reserved by Lituo Biotech. No part of this Instruction
for Use could be reproduced, exposed or allowed others to obtain without written permission of
Lituo. Any individual or organization cannot photograph, duplicate or translate the whole or
portion of the Instruction for Use without written permission of Lituo.

 The final explanation rights for this Instruction for Use are reserved.
 The Instruction for Use is subject to modification without prior notification.
 The technology is subject to change without prior notification.
 The specification is subject to modifications without prior notification.

The Liability of Manufacturer

Lituo is responsible for the safety, reliability and performance of instrument only under
below circumstance:
 Installation, augment, readjustment, improvement or maintenance is executed by the
personnel who are approved by Lituo.
 The installation place is in conformity with electrical standards IEC60601-1.
 The instrument is operated in the instructions of use.

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 Liquid-based Cytology Smear Instructions for

Contents

1. Legitimacy Verification..............................................................................................................3
2. Scope of Application...................................................................................................................3
3. Ancillary Reagents......................................................................................................................3
4. Instrument Installation and Components....................................................................................3
4.1 Instrument Components........................................................................................................3
4.2 Working Principles...............................................................................................................4
4.3 Technical Parameters............................................................................................................4
4.4 Performance..........................................................................................................................4
4.5 Precautions before Installation..............................................................................................5
4.6 Installation Procedures..........................................................................................................5
5. Operation instruction...................................................................................................................5
5.1 Explanation of function keys................................................................................................5
5.2 Operation Instruction............................................................................................................6
6. Safety and Maintenance..............................................................................................................9
7. Troubleshooting..........................................................................................................................9
8. Illustration of product labels, symbols, abbreviations, etc.......................................................10

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 Liquid-based Cytology Smear Instructions for

1. Legitimacy Verification

Product Name: Liquid Based Cytology Smear Processor

Model: LT-YJ2000
Registered Manufacturer: Hunan Lituo Biotechnology Co., Ltd.
Registration and Production Address: No. 129, Weiluoke Road, Wangcheng Economic
Development Zone, Changsha, Hunan, China.
Tel: 0086 731 82712733
Fax: 0086 731 82788168

2. Scope of Application

Applicable to smear preparation of cell specimens from human body prior to pathological
analysis

3. Ancillary Reagents

Used with Liquid-based Cytology Microbial Processing & Preservative Reagents manufactured by
Hunan Lituo Biotechnology Co., Ltd.

4. Instrument Installation and Components

4.1 Instrument Components

This device is consist of a shell, a specimen container, a suction & filtration device, a smearing
unit, a waste liquid retrieve device, a power supply part, and a control panel, etc.

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4.2 Working Principles

According to the principle of liquid-based cytology (LBC), the cells are absorbed by physical
suction and high-precision filtration membrane technology, and then the absorber cells are
transferred on the an anti-fall off glass slide and prepare a 20mm, thin layer, evenly-distributed
cells smear with adequate diagnostic materials.

4.3 Technical Parameters

4.3.1 Input Voltage: a.c. 220V、50Hz;

4.3.2 Input Power: 300W
4.3.3 Application environment:
——Ambient Temperature 15℃～30℃
——Relative Humidity 40％～85%
——Atmospheric pressure 86.0kPa～106.0kPa
——Without electric dust, explosive & corrosive gas, vibration sources.
4.3.4 Dimension: L480mm× D460mm× H410mm
4.3.5 Net Weight: less than 35kgs.

4.4 Performance

Single slide preparation time is less than 3.0 minutes.

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4.5 Precautions before Installation

a) The instrument should be installed in a steady and well-ventilated place without vibration
sources, direct sunlight, and vibration sources.
b) Open the package of instrument and place at the installation location. Ensure that all items
indicated on the packing list are intact and all parts (especially sockets, fuses, power cord,
movable glass door) are not damaged in the transportation.
c) Check whether the voltage of power source can satisfy the requirement of instrument
(a.c.220V 50Hz), and the ground connection is essential.
d) There is no contraindication.

4.6 Installation Procedures

a) Place and fix the waste barrel to the left of instrument.

b) Connect the two waste tubes and the liquid surface sensor tube to the corresponding
connectors in the back of the instrument.
c) Connect the waste barrel.

d) Connect power cord.

e) Complete the instrument installation.

5. Operation instruction

5.1 Explanation of function keys

The control panel has 7 keys including “Mode/Select”, “Confirm”, “Run”, “Reset”, “Set”,
“▲”、“▼”, their detail functions are as below:
1. Mode/Select key: press this key to enter the mode selection interface, the interface displaces

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current selected mode, the device serial number and prompt notes (press “Confirm” to exit)
2. Confirm key: press the key to save the setting.
3. Operate key: press this key to run and finish the smear preparation automatically;
4. Reset key: In case of emergencies (for example, membrane filtration tube is not installed),
press this key, the system will automatically stop production and return to the initial state.
5. Setting key: press this key to enter setting interface, you can carry out “Serial No. Setting” or
“Function Code Setting”; the system indicated notes “Press ▲、▼ to selct, Press confirm to
enter”.
6. ▲、▼ keys: press those two buttons to adjust the operation mode and input serial numbers.

5.2 Operation Instruction

1. Power on
Turn on the “Power Switch”, the machine performs a reset automatically which takes less than 10
seconds; after resetting, the main interface is displayed.
2. Input ancillary reagent serial number
1) There are twenty time trails for new instrument, after that the user need to input ancillary
reagents serial number so as to run the machine; if the serial number are expired, other serial
number have to be inputted. After the serial numbers are inputted successfully, instrument
can run 120 times.
2) Serial number input method
After the system enters the main operation interface, press “Set” key, the system displays two
setting functions: “Serial Number Setting” and “Function Code Setting”. The user presses
“Set” key to select the system default “serial number setting” function (white cursor display),
and then enter serial number input interface. Get the serial number (for example 12****3)
shipped with the ancillary reagents, firstly input the first digital “1”, press “▲” or “▼” to
adjust the number to “1”, then press “Set” key, the first number displays in white cursor,
which means the first number is entered successfully, and then enter the second number, and
so on, till the last number “3”, press “confirm” key (note: do not press “Set” key). If the serial
number is correct, system pops up “Serial number saved successfully”, the system returns to
the main interface after a few seconds, the serial number input is completed.
3) Ancillary reagent
Liquid-based Cytological & Microbial Processing and Preservative Reagent.
3. Mode Selection
There are six operation modes (Mode 1 to Mode 6) and two debugging modes (Mode 7 and Mode
8). From Mode 1 to Mode 6, collected number of cells increases gradually. Users could select the
proper operation mode according to specimen’s property.
For the gynecologic specimens like cervical exfoliative cells, the mode 2 is usually used. If you do

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not select a mode, the instrument will automatically work in the last mode.
4. Consumables & Reagents Preparation
1) Cell preservative solution
Check the information stated on bottle (name, age, numbers, date, collected liquid height, etc.)
and then compares with the information filled in test request form and glass slide, ensure the
three are correspondingly right. After confirming all information are correct, load the bottle
into the mixing stage as shown in below:

2) Membrane tube
Load the tube onto specimen suction station. Please make sure to check its sealing condition.
Please pinch the tube side during loading; do not touch the membrane by hand.

3) Anti-fall off glass slide

Hold the slide with character (coarse side) downward and white end with patient name on the
left; place the slide in the slide clamp. Don’t touch white circle area during the whole
operation.

4) Fix the collection cup

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Put the cup onto the collection cup holder; the cup can be placed for a long time, no need to
change.

5. Smear Preparation
Select working mode according to specimen property, close the door, then press “Run” key. The
instrument completes the smear preparation automatically following below procedures.
1) The instrument automatically checks the preparation of each consumable; after confirmation,
the system disperses the cells by centrifugal agitation.
Note: If there is an abnormity occurs, the instrument prompts the abnormal situation and
pause the operation.
2) After cells are dispersed, the system automatically collects the cells.
3) After collecting the cells, the suction station moves upward and rotate counterclockwise by
120°to evacuate residual liquid.
4) Then the suction station rotates counterclockwise by 60° so that the membrane tube is
perpendicular to the anti-fall off slide and then slowly rises to let membrane tube surface in
good contact with the glass. By controlling the air pressure, the cells are gently transferred on
the glass slide.

5) System separates the membrane tube from the slide. Then the specimen suction station rotates
clockwise by 180°and moves to the initial position.
6) Slide position plate rotates clockwise by 90° and drops the slide with collected cells into
collection cup.
Note: If the anti-fall off slide still remain in the slide clamp without being dropped in the cup,
please take out the slide immediately (probably due to moisture on the slide). Wipe the water
with absorbent paper at the slide clamp place after system resetting.

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7) The suction station moves upward; system discharge membrane tube and then reset
automatically, waiting for next command.
6. Consumables Removal
After operation, take out the slide from collection cup and place into the prepared fixation solution.
(Note: the collection cup in instrument can only hold one slide). Take out waste preservative
solution bottle; dispose in accordance with relative regulations.
The above mentioned fixation solution refers to 95% ethanol (recommended) or ethanol & diethyl
ether (1:1) mixture.
7. Switch Off
Switch off after operation.
8. Staining & microscopy observation
After the smears are fixed for 10 minutes or longer (Note: generally not staining overnight),
manually stain and seal the smear, observe the smear under microscopy by pathologist and
evaluate the results according to TBS reporting system.

6. Safety and Maintenance

1. All the designed technical parameters and instrument parts comply with national electrical
safety standards of medical devices. Please make sure to use triple-core power cord attached
with the instrument to ensure good grounding under normal operation.
2. Do not operate other function keys or close the door during operation.
3. Pay attention to safety when installing reagent bottles; avoid splashing the reagent contents on
body or in eyes.
4. The instrument should be placed horizontally, with good grounding and ventilation.
5. After using the instrument for 800 times, clean the pipeline with medical alcohol following
the same procedures of smear preparation (run the instrument once with alcohol).
6. On the condition that the instrument is used and maintained normally, the professional
personnel should execute maintenance once per year.
7. If failure happens, please contact manufacturer. Non-professionals are not allowed to
disassemble the instrument.

7. Troubleshooting

Problems Possible Causes Corrective Actions

Power indicator does not Bad connection of power socket
Re-plug power socket or change fuse
light. or blown fuse
Messy codes appear on Outer electromagnetic Press “Reset” key to refresh the

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screen. interference. screen.

No display on screen Blown fuse Change fuse
The inner parts cannot Press “Reset” key to reset
Interference of motor
move to proper positions. instrument.

8. Illustration of product labels, symbols, abbreviations, etc

Symbols Meaning

Keep away from rain

Fragile
Handle with care

This side up

The maximum stack limit is 2.

Keep away from the direct sunlight during

transportation and operation.

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Liquid-based Cytology Smear Instructions for

The surface of the instrument should be kept

clean and do not pour water on the bench.

Electric shock hazard.

It has possibility for biological infection, do

not directly touch he part.

These parts may cause injury. Do not

touch any moving parts while it is
running.