Mizuho Sugita T2 Clip Tray Series User manual

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MES-CK17-010-00EN
PREPARED: (2020-10-08) (Version 3)
Instruction for Use
Trade Name: Sugita T2 Clip Tray
Warning
1. For the US market
Do not reuse the device when it is used on a patient with or
suspected of having Creutzfeldt-Jakob Disease (CJD) or variant CJD
(vCJD).
2. For the market outside the US
When the device is used on a patient with or suspected of having
CJD or vCJD, make sure to adhere to the most recent and updated
restrictions available in each country and/or region for its reuse. Be
cautious of the possibility of secondary infection. Refer to
www.a-k-i.org or AAMI Standard ST79 for more information related
to cleaning and sterilization.
Contraindication / Prohibition
1. Use for intended purpose only
This product is intended to hold Sugita clips and dedicated forceps
for sterilization by a high-pressure vapor. The product must be
used as intended. [Misuse may cause damage.]
2. Prohibition of use of chemicals
Avoid exposing this product to chemicals. Doing so could damage
this product due to corrosion.
3. Handle with care.
Handle this product with care, as it can be deformed or damaged.
Rough handling could significantly reduce the service life of devices
and appliances.
4. Prohibition of use of polishing powder and wire wool
When cleaning this product, do not attempt to polish its surfaces
with rough polishing powder or wire wool. This could cause
scratches on the surface of this product and result in rust or
corrosion.
5. Prohibition of use of household detergents
Use only medical detergents to clean this product. Do not use any
household detergent. Washing this product with an improper
detergent could result in discoloration or corrosion.
6. Do not use low-temperature hydrogen peroxide gas plasma
sterilization. This product is not suitable for sterilization with
hydrogen peroxide low temperature gas plasma. It may discolor
the surface of the product or affect the feature of the product.
Symbol mark for labeling
MD : Medical Device
Specifications
Shape
Material: plastic, stainless steel
Code No Product Description
17-010-00 Sugita T2 Clip Tray Set (Tray A-G)
17-010-90 Sugita Aneurysm Clip Organizational Tray A.
(Clip Tray Basket Not Applier case)
17-010-91 Sugita T2 Clip Tray B. (For Mini and Standard Crankshaft clips)
17-010-92 Sugita T2 Clip Tray C. (For Standard Straight, Curved and L
shaped clips)
17-010-93 Sugita T2 Clip Tray D. (For Standard Curved and Long clips)
17-010-94 Sugita T2 Clip Tray E. (For Standard Fenestrated clips)
17-010-95 Sugita T2 Clip Tray F. (For Standard Fenestrated L Shaped
clips )
17-010-96 Sugita T2 Clip Tray G. (For All Temporary and Booster clips)
17-010-97 Sugita T2 Clip Tray H. (Customizable Tray for Standard and
Mini clips with 25 blank pockets)
17-010-98 Sugita T2 Clip Tray I. (Customizable Tray for Standard, Mini
and Long clips with 20 blank pockets)
17-010-99 Sugita T2 Clip Tray J. (For Temporary clips 001-51 to 58 only)
Intended purpose
This product is a tray that is used for sterilizing the SUGITA Titanium
Clips II with high-pressure steam.
Intended user
This product is to be used by health care professionals, including but not
limited to surgeons, nurses and biomedical technicians.
Instructions for use
Before using this product, inspect, wash, and sterilize in accordance with
these instructions.
Warning/Caution
1. Important fundamental cautions
Device must be sterilized by users in accordance with validated
sterilization procedures, such as an autoclave, that are regulated by
medical organizations in each country or region.
2. Defect/Adverse event
Defect
・Deterioration, corrosion or pitting caused by use of chemicals
・Damage or breakage caused by the corrosion or pitting
Storage/Life
1. Please store the device in normal ambient temperature areas. Do not
store in areas of high humidity where the temperature may
dramatically vary causing condensation. Do not store on or near
chemicals as the chemicals may cause damage to the device.
2.
Service life of this product: 5 years
(Subject to following manufacturer's specified maintenance,
inspection and proper storage requirements.)
Maintenance / Inspection
1. Check prior to each use
Operational and functional checks
Conduct daily and pre-operation checks of this product to make sure
that it functions properly.
2. Check after each use
2.1 Immediately wash with clean water
2.1.1 If exposed to bleach or antiseptic solutions, immediately
wash:
Wash and rinse with clean water immediately and immerse in
neutral enzyme detergent to remove any bleach or antiseptic
solution, which may contain chlorine or iodine and can
damage the instrument. Manually remove contaminated
matter by hand or with an ultrasonic-cleaner.
Read these instructions carefully before use.
Keep this instruction leaflet for future reference when necessary.

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2.1.2 Further remove any remaining contamination with a plastic
brush.
2.1.3 Select a proper detergent for each decontamination method
and maintain appropriate density and handling.
2.1.4 Use a soft towel, a plastic brush or a water jet for cleaning.
2.1.5 Avoid using metallic brushes or rough polishing agents,
applying excessive force, dropping or bumping the device,
etc.
2.1.6 Reverse osmosis water is recommended to wash this product.
2.1.7 Only use reverse osmosis water for the final rinse.
2.1.8 It is recommended to use a washer-disinfector for this device.
Thermal Disinfection can be used by following the
manufacturer’s defined parameters.: Thermal Disinfection
Band: 90-93 °C/194.0-199.4°F, 5-10 minutes (A0 value:
3000-12000) (reference EN ISO 15883-1)
2.2. Fully dry this product immediately after washing it. Do not leave it
wet for a longer time than necessary as residual water may
damage the instrument.
2.3. Use distilled water or reverse osmosis water at least
Use distilled water or reverse osmosis water to wash and sterilize
this product at least. Residual chlorine and organic matters in tap
water may cause stainings and/or rust and may damage the
instrument.
2.4. Use a water-based anticorrosive lubricant
Lubricating oil is completely removed by washing. After washing this
product, apply a water-based, anticorrosive lubricant prior to
sterilization.
3. Sterilization
Device must be sterilized by users in accordance with validated
sterilization procedures, such as an autoclave, that are regulated by
medical organizations in each country or region.
Maintenance and check by agents
For safety use of this device, conduct periodic checks by the
manufacturer or the agent recognized by the manufacturer.
Maintenance and check by other agents could cause the adverse events
and the decrease of the performance and the function. To schedule the
periodic check, contact your local distributor or the manufacturer.
Packing
1 piece per pack
Warranty
MIZUHO Corporation will repair defective parts of this product without
charge for one year from the date of delivery/installment except for
cases of damage caused by a third party’s repair, act of nature, improper
use or intentional damage. All other warranty terms and conditions are
subject to regulations of MIZUHO Corporation.
Disposal
This device must be disposed of in accordance with local regulations.
Please contact your local distributor for proper disposal.
Notice
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority in which the
user and / or patient is established.
Name and address of manufacturer
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
http://www.mizuho.co.jp
Authorized Representative in Europe
Emergo Europe B.V.
Prinsessegracht 20, 2514 AP, The Hague
The Netherlands