Be sure to read this instruction manual before using this product.

Keep this manual available for reference when needed.

MES-CK03-001-20EN-0
PREPARED: (2018-06-08) (Version 1)
Instructions for Use
Trade Name: Single Hook, Sharp

Warning Intended Purpose

Please read these instructions carefully prior to using this A hand-held, non-self-retaining surgical instrument
product. Product should be used according to these intended to be used to separate/draw aside the margins of a
instructions and pay close attention to the safety of wound/incision to allow access to tissues/organs during
patients. Not doing so may give rise to serious problems open surgery.
or adverse events.
For the US market Instructions for use
Do not reuse the device when it is used on a patient with Before using this product, inspect, wash, and sterilize in
or suspected of having Creutzfeldt-Jakob Disease (CJD) accordance with these instructions.
or variant CJD (vCJD). Cautions / Warnings
For the market outside the US 1. Warning
When the device is used on a patient with or suspected of Device must be sterilized by users in accordance with our
having CJD or vCJD, make sure to adhere to the most recommended sterilization procedures or the validated
recent and updated restrictions available in each country sterilization conditions for which validity has been proven by
and/or region for its reuse. Be cautious of the possibility of medical organizations in each country or region.
secondary infection. Refer to www.a-k-i.org or AAMI 2. Defect/Adverse event
Standard ST79 for more information related to cleaning Defect
and sterilization. - Corrosion and pitting caused by use of chemicals
- Damage or breakage caused by the corrosion or pitting
Adverse events
Contraindication / Prohibition - Broken pieces of metal from the damaged instrument
1. Use for intended purpose only falling into the patient.
Use tools for their intended purposes only. Incorrect use
Storage / Life
could cause breakage of this product.
1. Please store the device in normal ambient temperature
2. Prohibition of use of chemicals
areas. Do not store in areas of high humidity where the
Avoid exposing this product to chemicals. Doing so could
temperature may dramatically vary causing condensation.
damage this product due to corrosion. Do not store on or near chemicals as the chemicals may
3. Prohibition of secondary processing of this product cause damage to the device.
Do not apply any secondary processing to this product, 2. Service life of this product: 7 years
for example, do not apply impacts or vibration markings (Subject to following manufacturer's specified maintenance,
to the surface of this product. Doing so could break this inspection and proper storage requirements.)
product.
Maintenance / Inspection
4. Handle with care
1. Check prior to each use
Handle this product with care, as it can be deformed or Operational and functional checks
damaged. Rough handling could significantly reduce the Conduct daily and pre-operation checks of this product to
service life of tools and appliances. make sure that it functions properly.
5. Prohibition of use of polishing powder and wire wool 2. Check after each use
When cleaning this product, do not attempt to polish its (1) Immediately wash with clean water
surfaces with rough polishing powder or wire wool. This (1)-1 If exposed to bleach or antiseptic solutions, wash
could cause scratches on the surfaces of this product and and rinse with clean water immediately and immerse
result in rust or corrosion. in neutral enzyme detergent to remove any bleach
6. Prohibition of use of household detergents or antiseptic solution, which may contain chlorine or
iodine and can damage the instrument. Manually
Use only medical detergents to clean this product. Do not
remove contaminated matter by hand or with an
use any household detergent. Washing this product with
ultrasonic-cleaner.
an improper detergent could result in discoloration or
(1)-2 Further remove any remaining contamination with a
corrosion. soft nylon brush.
(1)-3 Select a proper detergent for each decontamination
Shape / Structure
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
Code No. Product Description
polishing agents, or apply excessive force when
03-001-20 Single Hook Sharp, Large ,5.9mm
handling the device.
03-001-21 Single Hook Sharp, Medium, 3.3mm
(1)-6 Only use distilled water or deionized water (reverse
03-001-22 Single Hook Sharp, Small, 1.8mm
osmosis) to wash this product.
Material: Stainless Steel
(1)-7 Only use fully deionized water (reverse osmosis) for
the final rinse.

1/2
 (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, 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) 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.
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.

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

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

2/2