Sakura Seiki Cyto-Tek 2500 User manual

Document Code: AJ5-RE-001-00
Supplement to the operating manual
Cyto-Tek® 2500
Cytocentrifuge
This document is a supplement to the following applicable operating manual
in order to comply with IVDR requirements.
Document code 0007129-01 Rev.C
0007129-01 Rev.D
Manufacturer: Sakura Seiki Co., Ltd. 75-5 Imojiya, Chikuma-city, Nagano 387-0015, Japan
www.sakurajp.com
Tel: [phone]

Document Code: AJ5-RE-001-00
Revision history
Version Date of
revision
Revision details
00 Mar.14
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 Cyto-Tek®2500, please
replace the corresponding section of the operating manual according to the table below.
Section
Change details
TABLE OF
CONTENTS
Add 1.6EN Applicable Standards.
Add 5.7 Expected Life.
Add 5.8 Transport.
Add 7. Symbols.
Add 7.1 Key for Symbols.
1.2
General Description
- Add a statement of the instrument.
The instrument is an in vitro diagnostic medical device.
1.4 Specifications
- Add a model.
CF-12E
- Add the overvoltage category.
Overvoltage category II
- Add conditions for altitude to the operating environment.
Altitude: 2,000 m or lower
- Change of storage temperature.
−20 to 60°C (−4 to 140°F)
- Change “Instrument Life Expectancy” to “Product life”.
- Change of Product life.
8 Years

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1.6
EN Applicable
Standards
-Change “Law” to “Rules and Regulations“
- Add the following table.
Rules and Regulations
CE Marking
Regulation (EU) 2017/746
Directive 2011/65/EU +
(EU)/2015/863
Electrical safety
evaluation
EN 61010-1
EN 61010-2-101
EN 61010-2-020
Risk management
EN ISO 14971
Medical device
software
EN 62304
Quality management
EN ISO 13485
Electromagnetic
compatibility
EN 61326-1
EN 61326-2-6
2.1
General Information
- Designate the operator to perform installation.
Installation should be performed by qualified service staff
dedicated to the instrument.
2.5.2
Options/Consumables
- Add options.
⑬ Bowl Lid Stand

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4. CARE OF THE
INSTRUMENT
- Add remarks to the Disinfection/Sterilization table.
Component
Additional remarks
Bowl Lid
When the part is disinfected 5 times a week
under the specified disinfection conditions
with the specified chemical solution, the
expected life is 3 years. When the part is
sterilized once a week under the specified
sterilization conditions, the expected life is 3
years (number of treatments: 160 times or
less).
Rotor
When the part is disinfected 5 times a week
under the specified disinfection conditions
with the specified chemical solution, the
expected life is 3 years. When the part is
sterilized once a week under the specified
sterilization conditions, the expected life is 3
years (number of treatments: 160 times or
less).
Guard Bowl
When the part is disinfected 5 times a week
under the specified disinfection conditions
with the specified chemical solution, the
expected life is 3 years. When the part is
sterilized once a week under the specified
sterilization conditions, the expected life is 3
years (number of treatments: 160 times or
less).
The expected life may change depending on
the disinfection conditions, cleaning
conditions, and storage conditions by the
user. The life of the instrument is when a
hole is made in the bowl unit, but not when
the color fades or scratches that do not
cause problems for centrifuge are
generated.

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Bowl Lid
Gasket
The bowl lid gasket and the V-shape
gasket are consumables. When
disinfection is performed 5 days a week,
and sterilization is performed once a
week, the expected life is 1year.
V-shape Gasket
5.3
Troubleshooting
Charts
- Add support for serious incidents.
If a serious life-threatening incident occurs, please contact the
regulatory authority in your country and Sakura Finetek Group.
5.4
Service Information
- Add support contact information for EU.
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]
5.5
Replacement and
Maintenance Parts
- Delete the parts.
Delete the following parts.
- F60-895-00 Bowl Lid
- F60-896-00 Bowl Unit
- F60-97-00 Rotor Unit

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5.7
Expected Life
- Add a section related to expected life.
Product life: 8 years after manufacture and shipment
Conditions:
The precautions and the maintenance/inspection items provided in
the operating manual and the instructions for use must be
observed, and the daily inspections and maintenance inspections
must be performed on a regular basis.
According to the inspection results, the major components listed
below and the replacement parts listed in the
maintenance/inspection items must be replaced as needed.
The major components supplied as maintenance parts are shown
in the table below.
Name of the major
components
Expected life
Controller board
5 years
Power supply
5 years
Detection sensor
5 years
DC motor
8 years
Motor driver
5 years
Guard bowl
3 years
* The product life of the instrument and the expected life of the
main components listed here is not the 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.
5.8
Transport
- Add an item related to transport.
When transporting the instrument due to relocation, trouble, etc.,
disinfect and sterilize the instrument as specified in the operating
manual before packing.
In addition, packing procedure should be done in the reverse order
of the unpacking procedure.
6.1.1 Dangers
- Add an item related to use of bleaching agents and
detergents.
●Do not use acidic detergent together with chlorine bleach when
chlorine bleach is used as a disinfectant. Failure to do so
generates chlorine gas and is dangerous.

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6.1.2 Warnings
- Add an item related to electromagnetic interference.
The instrument is designed and tested in accordance with Class A
of CISPR11. The instrument may cause electromagnetic
interference in a home environment. In such cases, you may have
to take measures to mitigate the interference.
6.1.3 Cautions
- Add an item related to installation location.
Install the instrument at a distance from other electrical equipment.
The electromagnetic waves, vibration, heat, or chemicals of the
instrument may affect or be affected by other peripheral
equipment.
- Add a measure to be taken before using the instrument.
Before operating the instrument, be sure to evaluate the
electromagnetic environment.
Example: Remove electrostatics from the operator and humidify
the room.
- Add an item related to the disposal method of the instrument.
Dispose of the instrument in accordance with national and regional
regulations and guidelines.

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7.1 Key for Symbols
- Add symbols and their meanings.
Catalog number
Batch code
in vitro diagnostic medical device
Use by
Manufacturer
Consult instructions for use
European Conformity
Authorized representative in the
European Community
New waste (WEEE)
Caution, consult accompanying documents
Keep dry
Fragile, handle with care
This way up
Do not stack
Serial Number
Date of manufacture
Humidity limitation
Temperature limitation

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7.1 Key for Symbols
- Add symbols and their meanings.
The product uses a Laser beam
Flammable reagents, solvents
and cleaning agents
Biological risks
Keep away from sunlight
General mandatory action sign
Power ON
Power OFF
General prohibition sign
Alternating current
UK conformity assessed

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Certificate of Decontamination (Sample)
End of document