DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 11

TABLE A. AddiMonal MedShape Cleaning InstrucMons.
Warnings
These guidelines are not intended for MedShape implants or single-use disposable
instruments – only for reusable instruments that are supplied non-sterile but are
intended to be used in a sterile state.
Use care in handling and storage of the instruments. Prior to surgery, instruments
should be fully inspected for any evidence of damage or corrosion.
Prolonged exposure to saline may result in corrosion of stainless steel instruments.
The quality of water should be carefully considered for use in cleaning reusable
devices. Water hardness is a concern because deposits leT on medical devices may
result in ineffec@ve cleaning and steriliza@on. The health care facility is responsible
for maintaining water quality that is compliant with AAMI TIR34.
All cleaning should be performed in a manner designed to minimize exposure to
bloodborne pathogens.
INSTRUCTIONS
Follow Universal Precau@ons for handling and transpor@ng contaminated
instruments to the designated cleaning area. Contaminated instruments should be
transported to the area for cleaning in a way that avoids contamina@on of personnel
and hospital.
Manual Cleaning
1.
2.
3.
4.
5.
6.
7.
8.
Automated
Cleaning/
DisinfecMon
Use flowing water and disposable wipes to remove excess soil.
Presoak the instruments with an enzyma@c solu@on for a minimum of five (5)
minutes.
Following the presoak the instruments should be wiped or scrubbed using a
brush, cloth or sponge that does not mar the surface of the instrument.
Rinse parts under cold (<45°C) sterile water for a minimum of one (1) minute.
Repeat the process un@l no visible debris remains.
Soak the instruments in Ultra Clean System Low Foam Detergent (pH neutral)
for a minimum of one (1) minute. Remove soil from surfaces with a soT-
bristled nylon brush and from cannulated parts with a soT-bristled nylon
brush, pipe cleaner, or appropriately sized guidewire. Ensure that all blood,
saline, and traces of @ssue are removed. The use of abrasive compounds or
excessively acidic or alkaline solu@ons may cause damage to the instruments
and should be avoided.
Rinse parts under warm or hot flowing, sterile water for a minimum of one
(1) minute including direct contact with all surfaces for at least ten (10)
seconds.
Repeat rinsing step using dis@lled, reverse osmosis or deionized water.
Washer-decontaminators may also be used in addi@on to manual cleaning. When
u@lizing an automated cleaner follow equipment manufacturers’ instruc@ons for use,
incorpora@ng a low foaming, pH neutral detergent. Take care to place difficult-to-
clean parts near the center of the rack, open-side down, minimizing touching
between parts. Place small parts in baskets to prevent dislodging.