Mizuho Evans DT Series User manual

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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】

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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, 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
soft nylon brush.
(1)-3 Select a proper detergent for each decontamination
method and maintain appropriate density and
handling.
(1)-4 Use a soft towel, a soft nylon brush, or a water jet for
cleaning.
(1)-5 To avoid damage, do not use a metal brush, coarse
polishing agents, or apply excessive force when
handling the device.
(1)-6 Only use distilled water or deionized water (reverse
osmosis) to wash this product.
(1)-7 Only use fully deionized water (reverse osmosis) for
the final rinse.
(1)-8 It is recommended to use a washer-disinfector for
this device
(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) Only use distilled or deionized water
Use distilled or deionized water to wash this product.
Residual chlorine and organic matters in tap water may
cause stainings and/or rust and may damage the
instrument.
(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.
Do not use this product without applying anticorrosive
lubricant on its sliding part. [Galling could occur.]
(5) Maintenance
(5)-1 After cleaning, visually inspect under ambient
lighting and confirm all dirt and debris has been
removed.
(5)-2 If any dirt or debris is visible, repeat cleaning and
lubrication steps.
(5)-3 Confirm that moving parts operate smoothly without
binding, excessive force or moving parts appear to
be loose and are rattling.
<Mizuho recommends the following procedures>
(1) Cleaning preparation
1) When handling devices contaminated with blood or
bodily fluids, wear appropriate protective equipment
such as masks, gloves, eye protection, and
waterproof aprons.
2) Do not allow blood or bodily fluids on devices to dry
on instrument.
3) The instrument is fragile so handle carefully
throughout the cleaning and sterilization process so
that the instrument and its tips are not damaged.
(2) Cleaning
<Manual Procedure>
1) Soak the product in cold tap water for 5 minutes,
covering all surfaces, and confirm that the lumen is
filled with water.
2) Before re-attaching the cleaning port to the product,
rinse with tap water and clean with a soft nylon brush
until all visible residue is removed from the surface of
the instrument. Be especially careful to clean the
connecting part of the cleaning port and the product,
upon completion re-attach the cleaning port to the
product. Carefully wash hinges, bonded parts, the
lumen, and other hard-to-reach areas, spray with
cold tap water with a water gun (at a maximum of 2
bars of water pressure) for 20 seconds.
3) Place the product into its washing basket and
ultrasonically clean at room temperature for 10
minutes in deionized water with a neutral enzyme
detergent dissolved to establish an 0.5% detergent
solution.
4) Carefully wash hinges, bonded parts, the lumen, and
other hard-to-reach areas, spray with cold tap water
with a water gun (at a maximum of 2 bars of water
pressure) for 20 seconds.
5) After cleaning you may remove the cleaning port.
<Automated Procedure>
Use a washer rack intended for cleaning the lumen.
1) Perform pre-cleaning for 2 minutes using tap water.
2) Drain the water.
3) Clean for 5 minutes in 55°C tap water with 0.3%
alkaline detergent solution.
4) Drain the water.
5) Rinse for 3 minutes with distilled or deionized water.
6) Drain the water.
7) Rinse for 2 minutes with distilled or fully deionized
water (reverse osmosis) for the final rinse.
8) Drain the water.
9) 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)
10)Thoroughly dry prior to use or storage.
11)After cleaning, remove the cleaning port and store it
until next cleaning procedure
(3) Only use a water-based, anticorrosive lubricant
Lubricating oil is completely removed by washing. Do
not use without lubricant oil to any sliding parts, or
galling could occur. After washing this product, apply a
water-based anticorrosive lubricant prior to
sterilization.
3. Sterilization
3.1 Remove the cleaning port before sterilizing the
product.
3.2 Device must be sterilized by users in accordance with
our recommended sterilization procedures or using
packaging materials for sterile products and the
validated sterilization conditions for which validity has
been proven by medical organizations in each country
or region.

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The recommended sterilization parameters are as follows,
Sterilization
method
Pre-vacuum steam sterilization
(Autoclave sterilization)
Sterilization
conditions
Sterilization temp. Retention time
132°C / 269.6°F 4 min
134°C / 273.2°F 3 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 markets 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.
Maintenance and check by agents
For safe use of this instrument, inspect device prior to and
after each use. Alternative or no review and/or inspection
may cause injury to the patient and/or healthcare worker
and may decrease the performance and function of this
device. Additionally, it is recommended to schedule a
periodic inspection through your local distributor or the
manufacturer.
Packing
1 peace per pack
Matters related to warranty period
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.
Name and address of manufacturer
MIZUHO Corporation
3-30-13 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
http://www.mizuho.co.jp