DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 12

Cleaning
VerificaMon Visually inspect all instruments for any remaining debris prior to steriliza@on.
According to ANSI/AAMI standard ST79:2010, the accepted standard for the degree
of cleanliness is “visibly clean”. To detect any residual blood or protein par@culates
that may be trapped in visually obstructed areas, the instrument may be submerged
in a 2% hydrogen peroxide solu@on. The appearance of bubbles confirms the
presence of protein and the instrument should be re-cleaned. Rinse instruments
following exposure to hydrogen peroxide. If bubbles were present or instruments
were not deemed visibly clean, steps 1-8 of the manual cleaning process should be
repeated.
InspecMon and
FuncMonal TesMng Repeated reprocessing has minimal effect on the devices. Visually inspect all
instruments for damage and wear. Cudng edges should be free of nicks and present
a con@nuous edge. Discard blunt or damaged instruments. Confirm that any moving
parts func@on properly. End of life is normally determined by wear and damage due
to use. Contact MedShape customer service for any replacements.
Packaging Singly: A standard packaging material may be used. Ensure that the pack is large
enough to contain the instrument without stressing the seals.
In Sets: Load MedShape Surgical Instruments into the appropriate instrument trays.
Ensure that cudng / sharp edges are protected.
Storage Packaged and sterilized instruments should be stored in an area that provides
protec@on from dust, moisture, insects, vermin, and extremes of temperature and
humidity. Containment devices can be stacked for storage.
SterilizaMon
Recommended steriliza@on methods have been validated to sterility assurance levels
(SAL) in compliance with federal and interna@onal standards. Other steriliza@on cycles
may also be suitable, but the individuals or hospitals are advised to validate other
methods for use with MedShape products. It is the responsibility of the user to
ensure that the steriliza@on process is actually performed using qualified equipment,
materials, and personnel such that the recommended parameters are achieved. The
adequacy of any healthcare facility steriliza@on procedure must be suitably tested. It
is cri@cal that the appropriate process parameters be validated for each healthcare
facility’s steriliza@on equipment and product/load configura@on by persons who have
training and exper@se in steriliza@on processes to substan@ate the process and its
reliability and reproducibility.
Any recommenda@ons provided herein are provided as general guidelines only.
It is important that adequate cleaning be carried out prior to steriliza@on. The
healthcare facility is responsible for in-house procedures for the reassembly,
inspec@on and packaging of the instruments aTer they are thoroughly cleaned in a
manner that will ensure steam sterilant penetra@on and adequate drying. Reusable
instruments should be placed in suitable packaging for the steriliza@on process (i.e.
central supply wrap (CSR), paper/plas@c pouches, rigid containers, etc.) and sterilized
prior to surgical use.
Always follow the sterilizer manufacturer recommendaMons. When sterilizing
mul@ple sets, ensure that the manufacturer’s maximum load is not exceeded.