Sakura Seiki Tissue-Tek Xpress x120 User manual

Document code: AI8-IE-001-00
Supplement to the operating manual
Tissue-Tek Xpress® x120
Rapid Tissue Processor
This document is a supplement to the following applicable operating manual
in order to comply with IVDR requirements.
Document code 0004389-03 Rev.C
Manufacturer: Sakura Seiki Co., Ltd. 75-5 Imojiya, Chikuma-city, Nagano 387-0015, Japan
www.sakurajp.com
Tel: [phone]

Document code: AI8-IE-001-00
Revision history
Version Date of revision Revision details
00 Feb. 21, 2022 First version.

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In order to comply with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), changes as
shown in the table below are made.
When using Tissue-Tek Xpress🄬 x120, please replace the corresponding section of the operating manual
according to the table below.
Section Details
Cover page P2 Manufactured for:
Sakura Finetek U.S.A., Inc.
Torrance, CA 90501 U.S.A.
Change the above to the following statement.
Manufactured for:
Sakura Finetek USA, Inc., Torrance, CA 90501 U.S.A.
Sakura Finetek Japan Co., Ltd., Tokyo, 103-0023, Japan
Sakura Finetek Europe B.V., 2408 AV Alphen aan den Rijn, NL
P1.2
Safety Precaution
- Add the following items.
NOTE： The instrument is an in vitro diagnostic medical device.
NOTE： The instrument should only be used by the operator who have
expertise or received training.
WARNING: Do not disassemble or modify the instrument.
The instrument may malfunction or cause an accident.
WARNING: Do not wet the instrument.
Wetting any part of the instrument may cause fire or electric shock due to
leak current.
WARNING: Do not operate the switches with wet hands or
connect/disconnect the power plug with wet hands. Connect/disconnect the
power plug by holding the plug. Failure to do so may result in electric
shock.
WARNING: Do not damage the power cord. Doing so may cause fire or
electric shock.
WARNING: Use only the supplied power cable. Do not replace or use an
improperly rated cord.
WARNING: Use only the specified solutions.
Use of any other solutions may result in improper processing and cause
malfunction.

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WARNING: Be careful of the handling the loading/unloading station
containers.
When setting/removing the loading station container and removing the
unloading station container, handle with care so as not to spill the solution
into the instrument. Failure to do so may cause fire or electric shock due to
leak current and may also cause instrument malfunction.
CAUTION: In the event of instrument malfunction, turn off the power.
In the event of instrument malfunction, turn off the instrument power and
call Sakura Technical Support.
CAUTION: Do not remove warning/caution labels from the instrument.
Without these labels, operator cannot be reminded of necessary warnings
and cautions for daily handling of the instrument, which may result in an
unexpected accident or injury.
CAUTION: Each retort and the paraffin chamber, etc. become very hot, so
be aware of burns.
Retort #3, Retort #4, unloading station, paraffin chamber, and the overflow
bottle parts are set to high temperatures, so be sure to handle with care.
CAUTION: Do not place any unnecessary items inside the instrument.
These items may interfere with movement of the transfer arm or the
opening/closing of the lid and may cause instrument malfunction.
CAUTION: Provide good ventilation around the instrument.
Some of the solutions used with the instrument are toxic or harmful to the
human body. Accordingly, provide good ventilation around the instrument.
CAUTION: Do not block the intake/exhaust ports around the system.
If the intake/exhaust ports are blocked, the instrument capability will drop,
and breakdown may occur.
CAUTION: Replace the activated carbon filters periodically.
In order to maintain a good environment around the instrument, replace the
activated carbon filters periodically.
CAUTION: Set the activated carbon in the instrument even when the
instrument is connected to the exhaust duct on the instrument side.

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CAUTION: Do not open or close the door unnecessarily during the
operation.
Except as instructed in this operating manual or by the instrument, do not
open/close the door unnecessarily. Also, do not leave the door open.
Failure to do so may stop processing.
CAUTION: Be careful of your head when opening the retort access door.
The retort access door opens to near your head. Also, metal protrusions
necessary to open/close the door are also assembled, so be very careful of
your head when opening the door.
CAUTION: When opening/closing the door, be careful not to pinch your
hand.
CAUTION: Be sure to close the drain valve of the paraffin chamber.
CAUTION: Be sure to close the maintenance valve of the pre-heating
chamber.
CAUTION: Be sure to close the plugs for cleaning the water pipes of Retort
#1 and Retort #2.
CAUTION: Remove the finished baskets immediately when running
continuous processing so that the baskets do not stagnate.
CAUTION: Do not irradiate the basket directly with microwaves.
Doing so may result in burns from the hot basket.
CAUTION: Make sure that the access door is securely closed after setting
the basket in the loading station.
If the access door is open, the processing does not start.
CAUTION: Be sure to inspect the instrument periodically.
Perform periodic maintenance and inspection to make sure the instrument
operates correctly at all time.
CAUTION: Shut down or turn off the power before cleaning.
Perform cleaning after shutting down or turning off the power unless
otherwise instructed in this operating manual.

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CAUTION: Be careful of paraffin adhesion after cleaning the basket.
If paraffin attached to the basket is brought into Retort #1 and Retort #2, it
may cause instrument malfunction. Clean the basket sufficiently according
to the instructions of this operating manual.
CAUTION: Be careful of the basket hook when baskets are not used.
When the baskets are not used (including cleaning), remove the basket
hook or keep the hook locked to the basket (pulled up to the top). If the
hook is placed on an unproper position to the basket, it may cause
deformation of the lock of the basket and may also cause instrument
malfunction.
CAUTION: Be careful to handle the instrument when moving the transfer
arm and opening/closing the lid of each retort manually. Hold the handle
when moving the transfer arm or opening/closing the lid by hand, such as
when cleaning.
CAUTION: When installing the instrument, place it on a level surface so
that it does not tilt.
CAUTION: Cut out specimens at an appropriate size.
Specimens that are cut out thickly are inappropriate and may not give good
processing results, so be sure to cut out specimens in an appropriate
thickness.
CAUTION: Be careful when handling the solutions.
Some solutions are toxic or harmful to the human body.
* Be careful to handle with care when replacing the loading station and the
solution bottle.
* If you are not going to run the instrument or process consecutively, place
the lid on the loading station container.
CAUTION: In order to prevent the set specimens from drying out, fill the
loading station with pre-processing solution.
CAUTION: Depending on the type of embedding cassettes and specimens
to be used, solutions may deteriorate quickly due to taking out or bringing
in of the solution.

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Replace solutions at an appropriate time depending on the situation even if
the number of cassettes is less than the limit of use or before the expiration
date.
Replace the solutions 1, 2, 3, 4, at the same time.
- Add "Product disposal method" section.
Dispose of the instrument in accordance with the regulations and
guidelines in each country.
In addition, when disposing of the instrument, erase the data in the
instrument completely.
In order to avoid problems including information leakage, it is
recommended to physically and magnetically destroy the data in the
instrument to prevent it from being read.
For information on how to do it, please contact the Sakura Finetek
Technical Support representative.
- Add "Security precautions" section.
CAUTION: If malware is introduced into the system, system control may be
lost. In that case, there is no guarantee that the instrument will operate
according to the specifications. Immediately stop using the instrument if
intrusion of malware is suspected, and contact your system administrator.
CAUTION: Confirm that the data to be loaded into the instrument is not
infected with a virus. Be sure to keep the OS (Windows) and the anti-virus
software provided with the OS (Windows Defender) installed on the
instrument updated to the latest version. The Sakura Finetek Group shall
not be responsible for any security incidents caused by the use of an OS
whose support has been suspended.
CAUTION: Special settings and preparation of a secure network are
needed to connect the instrument to a local area network. Should you
require LAN connection, consult the IT section of the facility.
For details, contact the Sakura Finetek Technical Support representative or
local representative.
Please note that the Sakura Finetek Group shall not be responsible for any
damage of hardware, damage of data, computer virus infection, or other
negligence caused by connection to an unsecured network or other
equipment.

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CAUTION: Only networks protected by firewalls are suitable for integration
of a network for the instrument. The Sakura Finetek Group shall not be
responsible for any errors caused by integration into unprotected networks.
CAUTION: Before connecting a USB flash memory, be sure to run a virus
check on the USB memory device.
CAUTION: Do not connect to the USB data port any peripheral device
other than an optional USB flash memory.
The USB data port is used to output data to a USB flash memory.
Connecting a peripheral device other than the USB flash memory may
cause the software to stop operating properly.
CAUTION: This instrument automatically logs in to the OS at startup. In
order to prevent malicious attackers from entering the installation location
and using the instrument illegally, it is recommended to take measures
such as restriction on access to the installation location.
CAUTION: Software upgrading and support
When there is a new release or new version of the software, upgrading and
support of the software or the internal firmware are provided by the Sakura
Finetek Technical Support representative.
For confirmation related to software updating and support, please contact
the Sakura Finetek Technical Support representative.
P1.12
Specifications
- Add the following.
Throughput: 120 cassettes per hour
Add the following in Environmental Requirements.
Install and use the instrument indoors.
- Add the following items in the Operating Conditions.
Altitude: 2000 m or lower
Overvoltage category: II

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P.1.13
Replace with
Instrument Product
Life
Replace with "Major components and expected life."
Product life: 7 years after shipment from manufacturer.
When replacing consumables or options, use the parts specified in this
manual. Use of other parts may result in malfunction or failure.
Name of the major components Expected life
Transfer and drive unit motor 7 years
Controller board 5 years
LCD unit 5 years
Detection sensor 5 years
Solenoid valve 7 years
Heater 7 years
Exhaust fan for exhaust gas treatm
ent unit
2 years
Other fans 7 years
Liquid feeding pump 7 years
Agitation pump
(Diaphragm)
2 years
(Consumables)
Vacuum pump
(Diaphragm)
2 years
(Consumables)
Magnetron 2 years
UPS main unit (optional)
(Battery)
5 years
(Consumables)
* The product life of the instrument and the expected life of the major
components listed here is not a warranty period, but an average number of
years when the above conditions are met, so it will vary depending on the
operating environment and the method of use.

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P.1.13
Safety Standards
- Replace Electrical Safety with the following.
For Model 7720 –
cETL Certification Complies with:
UL 61010-1, CAN/CSA-C22.2 No. 61010-1,
CAN/CSA-C22.2 No. 61010-2-010, IEC61010-2-010,
CAN/CSA-C22.2 No. 61010-2-081, IEC61010-2-081,
CAN/CSA-C22.2 No. 61010-2-101, IEC61010-2-101,
FDA Registration (Regulation No. 864.3875)
For Model 7721 –
Japanese Pharmaceutical Law Complies with:
ISO 13485, JIS C 1010-1, IEC 61010-1, IEC 61010-2-010,
IEC 61010-2-081, IEC 61010-2-101, JIS C1806-1,
JIS T 14971
For Model 7722 –
Regulation (EU) 2017/746 Complies with:
ISO 13485, EN 61010-1, EN 61010-2-010, EN61010-2-101,
EN ISO18113-1, EN ISO18113-3, EN ISO 14971
CISPR11, EN 50082-1, EN 61000-3-3, EN 61000-4-2,
EN 61000-4-3, EN 61000-4-4, EN 61000-4-5, EN 61000-4-6,
EN61000-4-11, EN 61326-1, IEC 61326-2-6
Directive 2011/65/EU + (EU)/2015/863
P.1.13
Regulatory
Information
- Replace the Regulatory Information with the following.
FDA Certified with ETL evaluation (USA);
Complies with requirements of The Pharmaceutical Affaires Law
(Japan);
Europe CE Marking & IVDR ((EU) 2017/746)
P.2.1
Environment
Factors
- Add installation environment.
Install the instrument in a location meeting the following conditions:
- Free from fire or ignition sources nearby
- Not exposed to direct sunlight
- A horizontal level and stable surface area
- Subject to minimum vibration
- Protected from water splashes
- Away from volatile substances or flammable materials
- Away from corrosive chemicals (acids, alkalis, etc.)
- Free from equipment that consumes high voltage or large current
Example) Large refrigerator, ultrasonic cleaner, cooling centrifuge, etc.
- Caution on electromagnetic environment

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The instrument is designed to operate in normal electromagnetic
environment. In any other electromagnetic environments, use the
instrument on user's own responsibility.
P.9.1
Where to Call for
Service
- Add support contact information for Sakura Finetek Europe B.V.
Contact us
Products and Security Information
Sakura Finetek Europe B.V.
Flemingweg 10a 2408 AV Alphen aan den Rijn, NL
URL: https://www.sakura.eu/
e-mail: [e-mail]
phone: [phone]
Newly add Section
10
- Add "Section 10 Symbols" section and the following details.
Key for symbols
Serial Number
Catalog number
Batch code
in vitro diagnostic medical device
Manufacturer
Consult instructions for use
European Conformity
UK conformity assessed
Authorized representative in the
European Community
New waste (WEEE)
Caution, consult accompanying documents
Biological risks
Flammable reagents, solvents and cleaning agents
The product uses a Laser beam
General mandatory action sign
General prohibition sign

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Keep dry
Fragile, handle with care
This way up
Use by
Do not stack
Date of manufacture
Temperature limitation
Humidity limitation
Keep away from sunlight
Alternating current
Power ON
Power OFF
Appendix - Add a Certificate of Decontamination sample on the next page.

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Certificate of Decontamination (Sample)
End of document.
If you are returning any used medical device to Sakura Finetek Group, please provide the following information
to help prevent contamination of other devices, etc., or living environment at our facility and the workers who
will be working on/handling your device. Fill out this Certificate of Decontamination and return it with the device.
If the device is not accompanied by this certificate, we will not unpack or repair the instrument. If the returned
medical device is deemed hazardous by Sakura Finetek Group, we will return the device to you immediately.
The cost of shipment will be borne by you.
 Date:
 Institution name:
 Equipment information
[Instrument name] [Model] [Serial number]
 Please answer the following questions regarding the usage status. (Circle where applicable. Use the Remarks field, if
necessary.)
Question Answer Remarks
1. Has this device been used at a hospital where legally designated
communicable diseases are treated?
Yes No
2. Has this device been used in a ward where patients of legally
designated communicable diseases are staying?
Yes No
3. Has this device been used in a room where pathological work on
infectious diseases is conducted?
Yes No
4. Has this device been used in a room where testing of infectious
diseases is conducted?
Yes No
5. Has this device been used in a room where articles used in
connection with infectious diseases are disposed of?
Yes No
6. Has this device been used in a room where research on special
viruses is conducted?
Yes No
7. Has this device been used in a room where articles used in
connection with special viruses are disposed of?
Yes No
 Please answer questions regarding disinfection.
Whenever possible, please return the device after cleaning/disinfecting it using general disinfectant, primarily in areas
that likely came in contact with tissues, operators, etc.
Examples of general disinfectants: Disinfecting alcohol, 70% isopropanol, biguanide alcohol, benzalkonium chloride,
Chlorhexidine
1. Date of disinfection
2. Method of disinfection
 Remarks