DAKEWE HP300 Plus User manual

HP300 Plus
Automatic Tissue Processor
User’s Manual
Revision V1.4-English Version- Jan. 2023

[Product Name] Automatic Tissue Processor
[Product model] HP300 Plus
[Production Date] Seen in label
[Manufacturer Name] Dakewe (Shenzhen) Medical Equipment Co., Ltd.
[Registered Address] Floor 5, Building B, No.2 Luhui Road, Jinsha Community, Kengzi Street,
Pingshan District, Shenzhen,China.
[Production Address] Floor 5, Building B, No.2 Luhui Road, Jinsha Community, Kengzi Street,
Pingshan District, Shenzhen,China.
[After-sales Service Organization] Dakewe (Shenzhen) Medical Equipment Co., Ltd.
[After-sales Service Organization] Floor 5, Building B, No.2 Luhui Road, Jinsha Community,
Kengzi Street, Pingshan District, Shenzhen,China.
[TEL] 0755-26413421
[Fax] 0755- 27383156
[Website] http://www.dakewemedical.com/

Foreword
Dear user,
Thank you for choosing our product!
In order to make you have an overall understanding of the Company’s product to facilitate your
use. We have specially configured this User Manual to the instrument, which includes the
instrument’s structural features, technical characteristics, instructions for use, simple
troubleshooting, maintenance, etc. For your ease of use this instrument.
Before use, be sure to read the User Manual carefully and follow the instructions correctly to the
user manual. In addition, if you have any questions during use, contact technical support, we will
be glad at your service.

Important Statement
The information, data, and precautions etc. contained in this Manual only represent the
scientific knowledge and advanced technologies that we currently possess through the institutes in
this field. Dakewe (Shenzhen) Medical Equipment Co., Ltd. reserves the right to make changes to
the manufacturing process subject to regulatory requirements without prior notice. In this way we
can continuously improve the technology and manufacturing techniques used in our products.
For the error descriptions, charts, technical illustrations, etc. contained in this Manual,
organizations or personnel are encouraged to give us feedback for updating. It is also important to
note that we shall not be liable for any direct or indirect economic loss or damage caused by
non-compliance with statements or other information in this Manual.
This document is protected by copyright law and all copyright in this document belongs to
Dakewe (Shenzhen) Medical Equipment Co., Ltd. Copying the text and illustrations (or any part
thereof) of this document by printing, photocopying, microfilming, webcam or other methods,
including any electronic systems and media, requires prior written permission from Dakewe
(Shenzhen) Medical Equipment Co., Ltd.
For the instrument serial number and year of manufacture, check the nameplate on the back
of the instrument.

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Table of Contents
1. Information..................................................................................................................................... 4
1.1 Symbol and Meaning............................................................................................................4
1.2 Instrument Use ......................................................................................................................6
1.3 Working principle................................................................................................................. 6
1.4 Personnel Qualification ........................................................................................................ 6
1.5 Instrument Model ..................................................................................................................6
2. Safety.............................................................................................................................................. 8
2.1 Safety Precautions ................................................................................................................ 8
2.2 Warning .................................................................................................................................9
2.2.1 Warning - Signs on the instrument ............................................................................ 9
2.2.2 Warning – Transport................................................................................................ 10
2.2.3 Warning – Installation ..............................................................................................10
2.3 Safety Functions on the Instrument ....................................................................................12
2.3.1 Pressure Monitoring ................................................................................................ 12
2.3.2 Temperature Monitoring..........................................................................................12
2.3.3 Flow Monitoring ......................................................................................................12
2.3.4 Component Monitoring ........................................................................................... 12
3. Instrument Components and Specifications.................................................................................13
3.1 Overview .............................................................................................................................13
3.2 Main Characteristics of the Instrument.............................................................................. 14
3.3 Technical Parameters ..........................................................................................................18
3.4 Compatible Reagents..........................................................................................................20
4. First Installation ............................................................................................................................21
4.1 Installation Requirements...................................................................................................21
4.2 Unpacking and Installation .................................................................................................21
4.3 Host / Hardware..................................................................................................................24
4.3.1 Installing the Monitor..............................................................................................24
4.3.2 Color LCD touch screen ..........................................................................................25
4.3.3 Dehydration Cylinder .............................................................................................. 25
4.3.4 Active Carbon Filter ................................................................................................ 28
4.3.5 Exhaust Pipe (optional)........................................................................................... 29
4.3.6 Marble Workbench .................................................................................................. 29
4.3.7 Tissue Sample Basket ..............................................................................................29
4.3.8 Paraffin Cylinder ..................................................................................................... 30
4.3.9 Waste Paraffin Collection Tray................................................................................31
4.3.10 Reagent Compartment and Reagent Bottle ...........................................................32
4.3.11 Reagent Bottle Label............................................................................................. 33
4.3.12 Reagent waste liquid collection module ................................................................34
4.3.13 Reagent automatic liquid change.......................................................................... 34
4.3.14 Cleaning xylene pre-heating..................................................................................35
4.4 Alarm Function................................................................................................................... 35
4.5 Main Power Supply and Power Jumper Connection..........................................................36
4.6 Instrument Startup and Login.............................................................................................36

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4.7 Touch Screen Functions......................................................................................................39
4.7.1 Screen lock...............................................................................................................39
4.7.2 Screen Protection .....................................................................................................40
4.8 Turn off the instrument.......................................................................................................40
4.9 Instrument handling............................................................................................................41
5. Instructions before use..................................................................................................................42
5.1 Access Level ....................................................................................................................... 42
5.1.1 Device Status Indicatio............................................................................................42
5.1.2 Main Interface ..........................................................................................................42
5.1.3 Soft Keyboard..........................................................................................................43
5.2 Access Level ....................................................................................................................... 44
5.3 Account login ......................................................................................................................45
5.4 User Interface ......................................................................................................................46
6. Menu module ................................................................................................................................ 47
6.1 Basic Function .................................................................................................................... 47
6.2 Relevant Settings................................................................................................................ 59
6.3 Advanced Module...............................................................................................................67
7. Reagent Processing.......................................................................................................................73
7.1 Reagent Filling / Evacuation / Replacement ......................................................................73
7.2 Paraffin Filling / Evacuation / Replacement...................................................................... 75
7.3 One-button automatic fluid change .................................................................................... 78
8. Start Program ................................................................................................................................ 79
8.1 Manual Running of the Dehydration Program...................................................................80
8.2 Program Operation Panel ....................................................................................................85
8.3 End Program ....................................................................................................................... 86
9. Cleaning and Maintenance........................................................................................................... 87
9.1 Rinse Program .................................................................................................................... 87
9.1.1 Rinse Process Step Operation..................................................................................88
9.1.2 Rinse Process Precautions.......................................................................................88
9.2 Regular Rinse ......................................................................................................................90
9.2.1 Daily Cleaning and Maintenance............................................................................ 90
9.2.2 Weekly Cleaning and Maintenance .........................................................................90
9.2.3 Monthly Cleaning and Maintenance ....................................................................... 93
9.2.4 Reagent Rinse ..........................................................................................................93
9.3 Regular Maintenance..........................................................................................................94
10. Troubleshooting.......................................................................................................................... 95
10.1 Fault Alarm Type.............................................................................................................. 95
10.2 Troubleshooting................................................................................................................95
10.2.1 Power Failure .........................................................................................................95
10.2.2 Safety Protection Reagent ..................................................................................... 96
10.2.3 Electronic Lock......................................................................................................96
11. Warranty and Service ..................................................................................................................97
11.1 Warranty ............................................................................................................................97
11.2 Technical Service Information ..........................................................................................97
11.3 Scrapping and Disposal .................................................................................................... 97
12. Hazardous Substance Information..............................................................................................98

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13. Electromagnetic Compatibility Indicators ..................................................................................99
14. RFID-Registration for the United States of America and Canada...........................................101

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1.Information
1.1 Symbol and Meaning
Danger:
Indicating an urgent dangerous situation that, if not avoided, will result in
death or serious injury.
Warning:
If you do not avoid this danger, it may result in death or serious injury.
Caution:
Indicating a potentially hazardous situation that, if not avoided, may
result in death or serious injury.
Note:
Indicating information that is not related to risk but is very important.
Follow this User Manual.
IVD medical device
The symbol indicating separate collection for waste
electrical and electronic equipment
Power on
Power off
Biohazard warning (black line on yellow background)
Sign indicator of using flammable solvents and reagents (black line on
yellow background)
This warning symbol indicates the instrument surface that will be hot
during operation.Avoid direct contact to prevent burns.

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Environmental protection sign of RoHS Directive. The figure in the
symbol refers to the product’s number of years of “environment-friendly
use”. Use this symbol if the use of a restricted substance exceeds the
maximum allowable limit.
Indicating that users are required to consult the User Manual for
important warning information, such as warnings and precautions.
Serial number
Manufacturing date
Manufacturer
No stacking
Limited height of 2 floors (accessory cases only)
Indicating the correct vertical position of the packing container.
Goods are fragile and must be handled with care.
The package must be stored in a dry environment.
Recycle in accordance with local laws and regulations.
Item indication number in the illustration.
Anti-tilt mark: it must be kept upright during transportation, and flow
crystal sand overflow occurs after 45°tilt.
Shockproof label: put it carefully during transportation. After impact, the display
bar will turn red

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Unique Device Identifier
Importer
The CE marking is the manufacturer’s declaration that the medical
product meets the requirements of the applicable EC directives and
regulations
UKCA mark
Name and Address of UK responsible person
FCC-Approved Equipment
1.2 Instrument Use
The automatic tissue processor is used for dehydration of samples prior to pathological
analysis and is intended for use in pathology laboratories only to perform the following tasks:
• Fixation, dehydration, transparency and wax immersion treatment of tissue samples;
• Only operate the instrument as described in this Manual.
Any other ways of use are regarded as inappropriate!
1.3 Working principle
The user puts the specimen with tissue into the tissue processing tank of the instrument,
and then clicks to start the pre-set dehydration program. The dehydrator will extract the
reagents into the tissue tank one by one according to the dehydration program set by the user
for soaking treatment. Each step can be individually set for dehydration time, temperature,
pressure mode and other parameters. After the program is executed, the dehydrator will
automatically prompt the user to remove the specimen in time.
1.4 Personnel Qualification
• Only trained laboratory staff can operate.
• Only operate the instrument as described in this Manual.
1.5 Instrument Model
The serial number (SN) of the instrument is on a nameplate attached to the back of the
processor.

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Software release version: V01
As described in nameplate
Be sure to observe the safety instructions and warnings in this Chapter.
Even if you are already familiar with the operation and use of the product, be sure to
read these instructions.

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2.Safety
2.1 Safety Precautions
This User Manual contains important information related to operational safety and equipment
maintenance.
As an important part of the product, the User Manual must be read carefully before
installation and use, and always be placed near the instrument.
This instrument is manufactured and tested in accordance with the safety requirements of
electrical equipment for measurement, control, and laboratory use. The product meets the
following safety and EMC testing standards:
(1) IEC61010-1:2010+A1:2016 Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1: General requirements.
(2) IEC61010-2-101: 2018 Safety requirements for electrical equipment for measurement,
control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic
(IVD) medical equipment.
(3) IEC61326-1: 2020 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 1: General requirements.
(4) IEC61326-2-6: 2020 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD)
medical equipment.
Most of the reagents used with the processor are flammable. Do not allow any source of
ignition to enter or come close to the instrument after loading the reagents.
In order to maintain this condition and ensure safe operation, the user must comply with
all safety precautions and warnings in this User Manual.

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Always observe the safety and precautions described in this Chapter.
Even if you are already familiar with the operation and use of other Dakewe
products, be sure to read these instructions.
Do not remove or modify the protective devices of the instrument and accessories.
Only Dakewe-certified qualified maintenance personnel can repair the instrument
and dispose of the instrument’s internal components.
The instrument is designed and manufactured with advanced technology and
complies with relevant safety technical standards and specifications. Improper
instrument operation or handling can result in injury to the user or other personnel,
damage to the instrument and other property damage. The instrument must be
used for its intended use and only when all safety functions are in proper working
condition. Faults that are detrimental to safety must be corrected immediately.
Only use original spare parts and permitted original accessories.
Do not remove or modify protective devices of the instrument and accessories. Only
authorized maintenance personnel are allowed to repair the instrument and dispose of the
instrument’s internal components.
2.2 Warning
The safety device installed by the manufacturer on this instrument only constitutes the
basis of accident prevention. The primary responsible party for the safe operation is the
organization, followed by the personnel assigned by the organization to operate, maintain or
repair the instrument. In order to ensure the smooth operation of the instrument, be sure to
observe the following instructions and warnings.
2.2.1 Warning - Signs on the instrument
The warning triangle is displayed on the instrument to ensure that correct operating
instructions defined in this Manual must be observed during operation and replacement.
Failure to follow these instructions may result in accidents, personal injuries, and
damages to the instrument or accessories.
The surface of the instrument that will become hot during operation is marked with this
warning label. Touching the surface marked on this warning label may cause burns.

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2.2.2 Warning – Transport
The instrument must be transported by the casters at the bottom, and one person is
required to push the instrument.
Pushing the instrument down from the packing box requires the use of the slope attached
to the packing box, which requires two people to cooperate.
The instrument must be parked on a level bottom surface, and the brakes of the casters
must be locked after parking.
After opening the package, the instrument must be moved upright.
Strictly follow the instructions for opening the package to avoid damage to the
instrument! The instrument may be shaken, tilted or lifted during transportation, so
before each transportation, the instrument must be emptied, including pipes, wax baths
and reagent bottles-otherwise the instrument will be damaged.
2.2.3 Warning – Installation
Observe the instructions for unpacking carefully to avoid damaging the instrument!
During transportation, the instrument may be shaken, tilted or lifted. Before each
transportation, the instrument must be drained, including piping, paraffin cylinder and
reagent bottle. Otherwise, the instrument may be seriously damaged.
Only insert the instrument into a securely grounded power socket. Make sure to use CB
(circuit breaker).
If the instrument is connected to a main power supply with a different voltage from the
indicated voltage on the nameplate, it may result in serious damage to the machine.
The installation site must be well ventilated. There is no type of flammable ignition
source.
High temperature fluctuations and high humidity between storage facilities and
installation sites may result in condensation. If this happens, you must wait at least two
hours before turning on the instrument. Violation of this requirement will damage the
instrument.
2.2.4 Warning - Reagent processing
Be very careful when handling reagents!
Rubber gloves and goggles must be worn when handling chemicals used in this
instrument.
Dispose of reagents carefully in accordance with regulatory requirements and the waste
management policy of your organization.

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2.2.5 Warning - Operation
The processor can only be operated by trained laboratory personnel according to the
intended use in this User Manual.
In case of emergency, turn off the main power supply and unplug the power cord.
Appropriate protective device to include lab coat, gloves and goggles must be worn when
operating the instrument.
Make sure that the instrument being operated is equipped with a strainer or exhaust pipe.
Even if the instrument is operated according to the specified purpose, dangerous solvent
flames can also be produced, which may harm the operator’s health and cause fire!
If need to interrupt the dehydration procedure for a long time, do not leave any tissue in
the processing cylinder to prevent the tissue from drying out.
2.2.6 Warning - Cleaning and maintenance
Before each maintenance or cleaning, the instrument shall be TURNED OFF and the
main power supply shall be disconnected. DO NOT use any solvents that contain acetone
or xylene to clean the instrument. Avoid liquid spillage on the internal components of the
instrument, including during operation and cleaning.
When using detergents, all safety requirements and laboratory management policies of
the product manufacturer shall be observed.
In any case, DO NOT flush the sites at high temperature. Otherwise, the sites may be
deformed!
Spilled solvents (reagents) must be wiped off immediately. Failing to do so could result in
corrosion of the processor!
In order to clean the lid, control panel and housing, use a mild household cleaner (such as
neutral soapy water).

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2.3 Safety Functions on the Instrument
The Dakewe HP300 Plus Automatic Tissue Processor is equipped with numerous safety
functions, and powerful software controls. It possesses a unique quality control function of
components, which can predict the operating status of the system, detect problems in
advance and process accordingly, so as to ensure that the samples will not be damaged in the
event of failure in the program. This feature enables the successful completion of the
program.
2.3.1 Pressure Monitoring
The instrument is equipped with pressure monitoring function, which is able to
automatically stop the pump action when the pressure is abnormal.
The system records the pressure setup time of each pressure setup process in the
quality control interface. The system automatically analyzes the change in pressure
setup time and system operation condition, and predicts the failure in advance.
2.3.2 Temperature Monitoring
Temperature control adopts multi-point acquisition and temperature protection
switch for temperature control and protection. Multi-point temperature control
improves the temperature control accuracy and safety factor. The temperature
protection switch, effectively prevents high temperature anomalies.
2.3.3 Flow Monitoring
The dehydration process utilizes flow monitoring. The system records the time
spent in each extraction and drainage, and automatically compares and analyzes the
system operation condition according to the standard time in order to predict the
occurrence of failure in advance.
2.3.4 Component Monitoring
The use time of key components of the HP300 Plus Automatic Tissue Processor is
monitored and recorded, including rotary valves, electromagnetic valves, air pumps,
seal rings and electronic chips. It is able to perform real-time recording and
analysis of the operational condition of system components, and predict the
occurrence of failure in advance.

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3.Instrument Components and Specifications
3.1 Overview
The automatic tissue processor consists of a dehydration module, which consists of a
control system, a sample transfer system, a retort, and a paraffin tank.
The processor is principally composed of a hardware control system, a fluid system, a
sample transmission system, a dehydration cylinder, a paraffin cylinder, an airway module,
and a man-machine interactive system, etc.
1 Dehydration cylinder
2 Tissue sample basket
3 Electronic lock and manual opening
knob for dehydration cylinder lid
4 USB port
5 Automatic fluid change connector
6 Active carbon filter
7 Paraffin cylinders (4)
8 Paraffin case door
9 Waste paraffin collection tray
10 Waste Collection Tray
11 Caster (4)
12 Reagent compartment’s glass door
13 Reagent bottles (14)
14 Host
15 Workbench area
16 Power switch
17 12.1inch color touch LCD screen
Figure 2 Front of HP300 Plus Automatic Tissue Processor

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1 Display regulating support frame
2 Power jumper output
3 Power jumper input
4 Power input
6 Network port
7 USB port
8 Exhaust gas interface
9 Handle to move
5 Leakage current protection switch
3.2 Main Characteristics of the Instrument
HP300 Plus is equipped with a 12.1-inch LCD touch screen. The screen can be adjusted
in three stages to adapt to different user habits.
The user interface displays the dehydration process in animation and clearly shows the
details and progress of all the steps. The menu level of the software is at most two
layers. The operation is user friendly.
HP300 Plus is pre-installed with three validated dehydration processes for small tissues,
standard tissues and standard tissues overnight, and are not editable. Three rinse
processes are included, namely fast rinse, standard rinse and warm rinse processes,
which are used to clean the residues in different situations, respectively.
Up to 100 user-definable dehydration processes available. Each program has up to 13
steps for user defined configuration (temperature, time, reagents, pressure / vacuum
and stirring options).
Automatically run the self-check function before the program runs, check the main
functional parts of the equipment in advance, and give early warning of the abnormal
state of the equipment in time to ensure the normal operation of the dehydration
program.
There are lights on the front of the dehydrator to indicate the current status of the
Figure 3 Back of HP300 Plus Automatic Tissue Processor

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equipment. Green means the equipment is in normal state, yellow means the
equipment is in the self-checking state, and red means the equipment is in the
pre-warning state, which is convenient for users to understand the state of the
dehydrator simply and intuitively.
With reagent management system (RMS), users can monitor the use of reagents based
on the number of cassettes, dehydration cycles or dehydration days.
There are three ultrasonic liquid level sensors in the tissue processing cylinder. Two of
them are used for liquid level detection. The top one is used to monitor and prevent
liquid overflow. The principle of ultrasonic detection is highly reliable, and it is not
easy to cause false alarms due to the accumulation of impurities on the probe surface.
The retort is equipped with a high reliability concentration detection sensor for reagent
concentration monitoring, which can detect the concentration of ethanol and other
reagents.
The cylinder lid of the tissue processing cylinder is automatically locked and opened by
the electronic lock, and is equipped with a double triggering device, so as to ensure the
safety and reliability of the cylinder lid locking.
The cylinder lid of the tissue processing cylinder has a heating effect, which can prevent
liquid from condensing on the inner wall of the cylinder lid during the dehydration
process, thus reducing cross-contamination and loss of reagents. The inner wall of the
cylinder lid is also coated with a Teflon plating layer, which serves to reduce the
residual adhesion of paraffin and reagent on the surface of the cylinder lid, facilitating
the cleaning of the inner wall of the cylinder lid.
The operator can choose two dehydration process modes of delay start or immediate
start, allowing for flexibility of the workflow.
The reagent bottle has position detection and blue light indicator, which serve to monitor
whether the reagent bottle is in the right place or not, and allows for easy observation
of reagent level. To ensure the normal operation of the dehydration program, the blue
light transmission function can make the liquid level in the reagent bottle clearly
visible, which is convenient for users to observe.
The HP300 Plus Processor has a total of 4 paraffin cylinders, among which the volume
of 3 paraffin cylinders is 4.2L. The 4th paraffin cylinder is a paraffin filling cylinder
with a volume of 5.6L. The wax bath has two scale lines for easy observation of the
liquid level. The paraffin cylinder can be supplemented or replaced if the paraffin in
other paraffin cylinders is insufficient or replaced, without affecting the normal
dehydration process.
The equipment has independent liquid and gas passages. The pumping pressure is about
-40kpa and the discharge pressure is about 30kpa.
The equipment is equipped with an innovative paraffin purification feature for removing
solvent residue in wax, extending its service life.

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Reagent Bottle Intelligent Identification System (RBIIS): identification module built in
every reagent bottle enables auto reagent information extraction and position detection
to streamline reagent management
The equipment is equipped with cleaning xylene pre-heating function, the heating
module under cleaning xylene bottles can heat reagent to 40 - 55℃, further improving
cleaning performance and efficiency.
The equipment is equipped with remote fill & drain function, the reagent ports
exclusively for easy and automatic remote fill& drain. Following auto pipe cleaning
eliminates cross-contamination.
Harmful reagent vapor, after being condensed, is filtered through an active carbon filter
before being discharged into the air. In addition, the gas can be discharged outside
through a separate interface on the back of the instrument.
It has four auxiliary dehydration functions such as normal pressure, pressurization,
vacuum, pressurization and vacuum alternately. It also has a stirring function, which
can promote the exchange of reagent liquid and ensure uniform concentration
distribution of soaking reagent.
The rotary valve made of ceramic material is used for reagent distribution, which has
good reagent compatibility and long service life; at the same time, the rotary valve has
a thermal insulation design to avoid the risk of clogging of the valve hole.
Each dehydration cylinder can hold up to 300 standard cassettes using 2 sample baskets.
Each basket can hold up to 150 standard cassettes. A single basket can hold 150
cassettes and a maximum of 2 baskets; a single basket can hold 70 cassettes and a
maximum of 4 baskets.
The equipment has a remote monitoring function, which can monitor the operating
status of the machine remotely. At the same time, it can automatically analyze the
operating status of the equipment and transmit the data to the cloud server. Users can
pay attention to the operating status of the equipment in real time and receive
abnormal warnings in time.
Users can transfer all the dehydration programs and logs via USB.
A multi-level password protection system can prevent unauthorized access to the
instrument.
Users can adopt the “reagent / paraffin liquid level check” function to ensure the
connection status of the reagent bottle.
If a power failure occurs, the alarm system will be triggered, promoting the HP300 Plus
to provide recovery measures after a power interruption.
If an error occurs, an alarm sounds immediately. The system will try to recover first, and
if it is not successful, the instrument will use a safety reagent to fill the dehydration
cylinder if the monitor is not operating within 20min, to ensure sample safety.
There are two alarm modes in total: local alarm and remote alarm to alert the user when