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MES-CK07-829-41EN-0
PREPARED: (2018-04-18) (Version 1)
Instructions for Use
Trade Name: Rotatable Micro Scissors DT
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. Not doing so may give rise to serious problems
or adverse events.
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).
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
Use tools for their intended purposes only. Incorrect use
could cause breakage of this product.
2. Prohibition of use of chemicals
Avoid exposing this product to chemicals. Doing so could
damage this product due to corrosion.
3. 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.
4. Handle with care
Handle this product with care, as it can be deformed or
damaged. Rough handling could significantly reduce the
service life of tools and appliances.
5. 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 surfaces of this product and
result in rust or corrosion.
6. Prohibition of use of acid and household detergents
Use only medical neutral detergents (pH 6 to 8) to clean
this product. Do not use any acid or household detergent.
Washing this product with an improper detergent could
result in discoloration or corrosion.
7. 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.
Shape / Structure
・
45 deg Up
・
Straight
・
Curved
・
125 deg Back Cutting
Code No.
Product Description
07-829-41
Evans Rotatable Micro Scissors 11cm WL, 45deg. Up,
DT
07-829-42
Evans Rotatable Micro Scissors 15cm WL, 45deg. Up,
DT
07-829-43
Evans Rotatable Micro Scissors 11cm WL, Str. DT
07-829-44
Evans Rotatable Micro Scissors 15cm WL, Str. DT
07-829-45
Evans Rotatable Micro Scissors 11cm WL, Cvd. DT
07-829-46
Evans Rotatable Micro Scissors 15cm WL, Cvd. DT
07-829-47
Evans Rotatable Micro Scissors 11cm WL, 125deg. Back
Cutting, DT
07-829-48
Evans Rotatable Micro Scissors 15cm WL, 125deg. Back
Cutting, DT
Material: Stainless Steel, Gold Plating
Intended Purpose
This product is a surgical instrument used to cut tissue, cloth,
and a suture. It is composed of two flutes that have
rotational axes, and it is operated by closing the flutes over
materials which are supposed to be cut.
Instructions for use
Before using this product, inspect, wash, and sterilize in
accordance with these instructions.
Cautions / Warnings
1.
Warning
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
- Corrosion and pitting caused by use of chemicals
- Damage or breakage caused by the corrosion or pitting
- Plating adhesion failure
Adverse events
- Broken pieces of metal from the damaged instrument
falling into the patient.
3.
Important fundamental cautions
This product has a removable cleaning port. The cleaning
port is attached to clean the lumen . When cleaning is
complete, remove it. Refer to
【
Figure 1
】
.
Be sure to read this instruction manual before using this product.
Keep this manual available for reference when needed.
The cleaning port is
attached to the lumen .
The cleaning port is
removed from the lumen.
Cleaning port
【
Figure 1
】