OPHTEC ARTISAN DO6-41 User manual

▪ :
▪ : 18-752
▪ : DO6-41
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Sihong Surgitrac Co., Ltd( , No.2 Xihu Road, Sihong Industrial Park,
223900, Jiangsu, P.R. China)
[ ]
, 87 33, 7
: 2022 4 (A502000005 rev2.0)
A
RTI
SAN Manipulator Standard Straight
본 제품은 의료기기 임

▪ Product name: Retractor, surgical, manually-operated
▪ Product license no.: Sushin 18-752
▪ Model name: DO6-41
[Intended Use]
Manual device used to open the affected area, such as hooks, separators
and retainers.
[Instructions for use]
A. Preparation before use
1) Check the device maintains clean and sterilization for use
2) Before use, check the device for deformed appearance, pinhole,
foreign substance adhesion etc
B. Instruction for use
1) After selecting the patient, choose the tool that suits the purpose and
function.
2) Grip the handle of the product.
3) Spread the eye tissue and place the lens before inserting the
ARTISAN/ARTIFLEX lenses.
C. Storage and Care method after use
Re-sterilization
1) Steam sterilization: 134-137°C for 3-3.5 minutes.
Storage
1) Always store sterile instruments in a clean, dry environment, away from
sunlight.
Cleaning
1) Rinse excess soil from device.
2) Fully immerse device into a detergent solution not exceeding 30°C.
3) It is recommended that the device be cleaned as soon after use as
possible, however where blood, tissue, saline or viscoelastic has been
left to dry it is recommended that the device is left to soak for 30
minutes in the detergent solution.
4) Using a brush, wash and scrub vigorously applying detergent solution
to all surfaces ensuring that hinged devices are cleaned in both open
and closed positions.
Drying
1) When drying is achieved as part of a washer disinfector cycle, do not
exceed 170°C.
2) Products may be dried using filtered compressed air.
Inspection
1) Inspect lubrication condition and check the operating condition
through visual inspection
2) Remove for repair or replacement any blunt, worn out, fractured or
damaged devices.
3) If ANY soil or fluid is still visible, return the device for repeat
decontamination.
[Cautions in use]
A. Cautions in use
1) Never use reusable instruments that have not been cleaned,
disinfected and sterilized first.
2) The use of contaminated products may cause injury or illness to the
patient.
3) Follow instructions and warnings as issued by manufacturers of any
decontaminants, disinfectants and cleaning agents used. Wherever
possible avoid use of mineral acids and harsh, abrasive agents.
4) The products are precision surgical devices, the utmost care must be
taken at all times when handling these devices to avoid damage.
5) No part of the process shall exceed 170°C.
6) When reprocessing medical devices, always handle with care,
wearing protective clothing, gloves and eyewear in accordance with
local Health & Safety procedures.
7) End of life is normally determined by wear and damage due to use.
8) Stains may occur when the device is sterilized, so follow the
instructions from the sterilizer manufacturer, and do not open the
cover until the steam is completely removed.
9) When water containing a lot of iron is used during cleaning, a film
painted with rust may be formed, so use after discussing the rating
evaluation of the water treatment problem with expert.
10) Corrosion can occur when blood is buried and harden at the
deadlock, chopper and rings, so completely open up all deadlock
before cleaning.
11) When exposed to salinity solution, blood, calcium chloride and many
other compounds, the dent may occur, so rinse with distilled water
as soon as possible after exposures.
12) Use only for the designated purpose and do not use it for other
purpose.
13) If problems occur during storage and use, contact the manufacturer
for follow-up and prevention of recurrence.
[Storage method]
Store at room temperature
[Legal & Physical Manufacturer]
Sihong Surgitrac Co., Ltd(No.2 Xihu Road, Sihong Industrial Park, 223900,
Jiangsu, P.R. China)
[Name and the address of the importer]
Ophtec Korea Ltd, 7FL, Teheranro 87Gil 33, Gangnam-gu, Seoul
Written Month/Year: April 2022 (A502000005 rev2.0)
ARTISAN Manipulator Standard Straight
This product is a Medical Device