Microline Surgical M/L-10 Manual Del Usuario

M/L-10 Clip Applier Sterilization Tray (Catalog # 3706) - Instructions For Use
INDICATIONS FOR USE
Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002)
and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared
1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used.
The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog
#1002) which measures at 17.13" length, 4.94" height, and 0.90" width in dimensional measurements, as the intended load during the transport,
sterilization and storage between its intended uses.
The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped
in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization
Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of
132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.
CONTRAINDICATIONS
The M/L-10 Clip Applier Sterilization Tray (3706) is not intended for use except as indicated.
COMPONENTS OF A M/L-10 CLIP APPLIER STERILIZATION TRAY
The M/L-10 Clip Applier Sterilization Tray (3706) consists of:
1. One perforated stainless steel Lid.
2. One perforated stainless steel Base.
3. Silicone brackets.
4. Alluminum brackets.
PRE-CHECK INSTRUCTIONS
1. Carefully inspect the packaging to ensure that there are no signs of damage. If damage is visible, do not use the sterilization tray (3706).
2. Ensure that the sterilization tray (3706) received is utilized for the M/L-10 Clip Applier device only as specified by the supplied IFU.
DEVICE DESCRIPTION
The Microline Surgical M/L-10 Clip Applier sterilization tray (Catalog #3706) is used to secure the M/L-10 Clip Applier device as intended load
during the transport, sterilization and storage between intended use. The sterilization tray (3706) consists of a stainless steel case, a stainless
steel cover and silicone and aluminum brackets. The cover is secured to the case by means of assembled hardware and a locking tab, designed
as a part of the lid cover. The brackets are designed to secure the M/L-10 Clip Applier for sterilization. The tray cover and case are designed
using stainless steel, which can be reused with steam sterilization methods. The brackets are constructed from aluminum, stainless steel, and
biomedical grade silicone. The case and cover have an evenly distributed hole pattern in relation to its size. The M/L-10 Clip Applier sterilization
tray (3706) has been validated weighing 1663.10 grams for cleaning and sterilization cycles. The validated prevacuum cycle parameters are
as follows: Time: 4 minutes, and temperature:132 °C.The gravity cycle parameters are as follows: Time: 15 minutes, and temperature: 132 °C.
These cleaning and sterilization cycles are validated with the sterilization tray (3706) wrapped in 2 layers of FDA-cleared 1-ply polypropylene
wrap. The M/L-10 Clip Applier sterilization tray (Catalog #3706) is intended for over-the-counter use only.
PREPROCESSING INSTRUCTIONS
Prior to use, follow the guidelines below for applicable cleaning and sterilization methods.
MANUAL CLEANING (minimum required steps)
1. Rinse with running tap water to remove gross soil.
2. Prepare enzymatic detergent solution in accordance to the manufacturer's recommendations.
3. Immerse in enzymatic solution; allow to soak for a minimum of five (5) minutes.
4. Clean the device of any visible signs of contamination using a soft bristled brush.
5. Rinse with lukewarm running tap water.
6. Rinse with deionized water. Repeat 3 times.
7. Dry completely with a clean, soft, lint-free cloth.
8. Visually inspect to ensure all soil is removed.
AUTOMATED CLEANING
1. Rinse with running tap water to remove gross soil.
2. Load device(s) into automated washer. Load devices(s) in the open position.
3. Automated wash cycle parameters as follows:
Instrument Cycle: High
Phase Time (Minutes)
Pre-Wash 2:00
Wash 1 2:00
Rinse 1 00:15
PURW Rinse 1:00
Dry 6:00
4. Visually inspect to ensure all soil is removed.
5. Package appropriately for sterilization.
STERILIZATION
Sterilization Method Temperature
Pre-vacuum 132 °C
Gravity 132 °C
INSTRUCTIONS FOR USE
1. Clean and disinfect the used M/L-10 Clip Applier device (1002) as per the M/L-10 Clip Applier IFU (IFU0030), then secure M/L-10 Clip Applier
device in the silicone and aluminum brackets of the sterilization tray (3706).
2. Cover the base with the lid and secure the locking tab.
3. Wrap the sterilization tray with 2 layers of FDA-cleared 1-ply polypropylene wrap.
4. Sterilize the loaded wrapped tray in accordance with the M/L-10 Clip Applier device manufacturer's guidelines for steam sterilization methods.
5. After steam sterilization, move the wrapped sterilization tray to a sterile storage area for storage or transport to the point of use location.
6. Return the sterilization tray (3706) to the sterile processing department after use.
7. The sterilization tray (3706) is reusable and should be cleaned and decontaminated prior to reuse.
STORAGE CONDITIONS
After sterilization, product should be stored in a clean, dry place.
ENVIRONMENTAL PROTECTION
To reduce contamination risks, the M/L-10 Clip Applier Sterilization Tray (3706) shall be disposed of in compliance with all applicable local, state
and federal laws and regulations.
WARRANTY
Microline Surgical warrants that its instruments are free from any defects in both material and workmanship. Microline Surgical shall not be held
liable for any incidental or consequential damage of any kind. Work performed on an instrument will void this warranty. Gross abuse or neglect
of a Microline Surgical instrument will void this warranty.
M/L-10 Clip Applier Sterilization Tray
Instructions For Use
Microline Surgical, Inc.
50 Dunham Road, Suite 1500
Beverly, MA 01915 U.S.A.
Tel: +1(978) 922-9810 | Fax: +1(978) 922-9209
Web: www.microlinesurgical.com
Email: [email protected]
09-39-00238-00-ART Rev A 2/2016
Temperature Detergent
Cold Tap Water N/A
65.5 °C Alkaline Detergent
Hot Tap Water N/A
90 °C N/A
98.8 °C N/A
Sterilization Parameters
Time Sterilization Wrap
Wrapped in two layers of 1-ply
4 minutes
polypropylene wrap of appropri-
ate basis weight to accomodate
the weight of the sterilization tray.
15 minutes
ENGLISH