Mizuho SUGITA AVM Microclip II CASE B User manual

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MES-CK07-932-11EN
PREPARED: (2023-10-03) (Version 1)
Instruction for Use
Trade Name: SUGITA AVM Microclip II CASE B
Warning
Please read these instructions carefully prior to using this product.
Product should be used according to these instructions, and pay close
attention to the safety of patients. Failure to follow manufacturer's
recommendations may cause harm or injury to the patient.
Contraindication/Prohibition
1. Use for intended purpose only
This product is intended to hold Sugita AVM Microclip II for
sterilization by a high-pressure steam. [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. 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.
4. Prohibition of secondary processing of this product
Do not apply any secondary processing to this product, for
example, do not apply impacts or vibration markings to the surface
of this product. Doing so could break this product.
Specifications
Code No. Product Description
07-932-11 SUGITA AVM Microclip II CASE B
Material: resin
Intended purpose
This product is a case that is used for washing the Sugita AVM Microclip
II and sterilizing it 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.
・After setting the Sugita AVM Microclip II and the individual case in this
product, lock the lid with the grip.
・Sterilization of the Sugita AVM Microclip II can be performed with this
product by itself or by placing this product in "07-932-10: SUGITA
AVM Microclip II CASE A".
Warning/Caution
1. Important fundamental cautions
Device must be sterilized by users in accordance with our
recommended sterilization procedures or the validated sterilization
conditions for which validity has been proven by medical
organizations in each country or region.
2. Defect/Adverse event
Defect
・Deterioration caused by use of chemicals
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
(1) Immediately wash with clean water
(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.
(1)-2 Further remove any remaining contamination with a plastic
brush.
(1)-3 Select a proper detergent for each decontamination method
and maintain appropriate density and handling.
(1)-4 Use a soft towel, a plastic brush or a water jet for cleaning.
(1)-5 Avoid using metallic brushes or rough polishing agents,
applying excessive force, dropping or bumping the device,
etc.
(1)-6 Reverse osmosis water is recommended to wash this
product.
(1)-7 Only use reverse osmosis water for the final rinse.
(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) 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.
(3) Use distilled water or reverse osmosis water
Use distilled water or reverse osmosis water to wash and sterilize
this product. Residual chlorine and organic matters in tap water
may cause stainings and/or rust and may damage the
instrument.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
Individual case
Grip
Lid

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(4) Use a water-based lubricating agent and a water-based
rust-prevention agent
Lubricating oil is completely removed by washing. After washing
this product, apply a water-based, anticorrosive lubricant prior to
sterilization.
(5) Prohibition of use of alkaline, acid, and household detergents
Use only medical neutral detergents (pH 6 to 8) to clean this
product. Do not use any alkaline, acid, or household detergent.
Washing this product with an improper detergent could result in
discoloration or corrosion.
3. Sterilization
(1) 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) 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.
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.
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
https://www.mizuho.co.jp