Be sure
Read to read
these this instruction
instructions manual
carefully beforebefore
use. using this product.
Keep this manual available
instruction leafletfor
for reference when needed.
future reference when necessary.
MES-CK07-917-01EN-0
PREPARED: (2017-12-15) (Version 1)
Instructions for Use
Trade Name: Ring Curette
Warning
Shape / Structure
1. 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. Not doing so may give rise
to serious problems or adverse events.
2. 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).
3. 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 Code No. Product Description
1. Use for intended purpose only 07-917-01 Ring Curette, Bayonet 4mm, Malleable
Use devices for their intended purposes only. Incorrect use could 07-917-02 Ring Curette, Bayonet 4mm, Upward
cause this product to break. 07-917-03 Ring Curette, Bayonet 4mm, Forward
2. Use with specified products only 07-917-04 Ring Curette, Bayonet 3mm, Downward
Use this product with only products specified by Manufacturer. 07-917-05 Ring Curette, Bayonet 3mm, Upward, L
Other products than those specified by Manufacturer could be 07-917-06 Ring Curette, Bayonet 3mm, Upward, S
incompatible with this product due to differences in design and 07-917-07 Ring Curette, Bayonet 3mm, Forward
development policies.
3. Prohibition of use of chemicals Material: Stainless Steel
Avoid exposing this product to chemicals. Doing so could damage
Intended Purpose
this product due to corrosion.
A device which has a hollow, e.g. ring, shape distal end and a handle by
4. Prohibition of secondary processing of this product which it is held. It is used to scrape lesion, body or other tissues. This
Do not apply any secondary processing to this product. For device is reusable
example, do not apply impacts or vibration markings to the surface
Instructions for use
of this product. Doing so could break this product.
Before using this product, inspect, wash, and sterilize in accordance with
5. Handle with care
these instructions.
Handle this product with care, as it can be deformed or damaged.
Rough handling could significantly reduce the service life of devices Caution
and appliances. 1. Warning
6. Prohibition of use of polishing powder and wire wool Device must be sterilized by users under the standard sterilization
When cleaning this product, do not attempt to polish its surfaces conditions or the validated sterilization conditions which validity is
with rough polishing powder or wire wool. This could cause proven by medical organizations in each country or region.
2. Defect/Adverse event
scratches on the surface of this product and result in rust or
2.1 Defect
corrosion
- Corrosion and pitting caused by use of chemicals
7. Prohibition of use of household detergents
- Damage or breakage caused by the corrosion or pitting
Use only medical detergents to clean this product. Do not use any
2.2 Adverse event
household detergent. Washing this product with an improper - Broken pieces of metal from the damaged instrument falling into
detergent could result in discoloration or corrosion. the patient.
Storage/Life
1. Storage
Do not store the device in high temperature or in areas with high
humidity with drastic temperature or humidity variations.
2. Service life of this product: 5 years
(Subject to the specified maintenance, inspection, and proper
storage)
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Maintenance / Inspection
Matters related to warranty period
1. Operational and functional checks
MIZUHO Corporation will repair defective parts of this product without
Conduct daily and pre-operation checks of this product to make sure
charge for one year from the date of delivery/installment except for
that it works properly.
cases of damage caused by a third party’s repair, act of nature,
2. Immediate washing with clean water
2.1 Wash and rinse with clean water immediately and immerse in improper use or intentional damage. All other warranty terms and
neutral enzyme detergent in case the device is exposed to conditions are subject to regulations of MIZUHO Corporation.
bleach or antiseptic solution, which may contain chlorine or
Name and address of manufacturer
iodine. Then remove all the contaminated matter by hand or an
MIZUHO Corporation
ultrasonic-cleaner. 3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
2.2 Remove any remaining contamination with a brush. http://www.mizuho.co.jp
2.3 Select a proper detergent for each decontamination method and
maintain appropriate density and handling. Use of a neutral
detergent is recommended.
2.4 Use a soft towel, a plastic brush, or a water gun for cleaning.
2.5 Do not use a metal brush, coarse polishing agents, nor apply
excessive force when handling the device.
2.6 Use distilled water or deionized water to wash this product.
2.7 Use fully demineralized water (reverse osmosis) for final rinse.
2.8 Using an ultrasonic washing machine for this device
simultaneously is recommended.
3. Dry this product immediately after washing it. Do not leave it wet for
a longer time than necessary.
3.1 Please rinse the frame fully, for more than 5 minutes, by warm or
cold water without additives after cleaning.
3.2 Dry this product immediately after washing it. Do not leave it wet
for a longer time than necessary.
4. Use distilled or deionized water
Use distilled or deionized water to wash this product.
Residual chlorine and organic matters in tap water could cause stains
and rust.
5. Use a water-based anticorrosive lubricant
Lubricating oil is completely removed by washing. Do not use without
lubricant oil to sliding part, or galling could occur. After washing this
product, apply a water-based anticorrosive lubricant prior to
sterilization.
6. 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.
Do not use hydrogen peroxide gas plasma sterilization.
Sterilization of the device may be accomplished by steam. The
recommended sterilization parameters are as follows,
ISO/TS17665-2
Temp. Minimum exposure time
121°C / 249.8°F 15 Min
126°C / 258.8°F 10 Min
134°C / 273.2°F 3 Min
Temp. Minimum exposure time
134°C / 273.2°F 18 Min
For the US market
FDA has not approved or cleared medical devices, including sterilizers,
for the intended use of reducing the infectivity of TSE agents (i.e.,
prions).
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.
Packing
1 piece per pack
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