DynaNail® TTC Fusion System - Instructions For Use | MedShape DynaNail® TTC Fusion System - Instructions For Us | Page 13

The DynaNail Instrument Caddy is designed to hold the DynaNail Deployment Frame
and all of the Ancillary Surgical Instruments during steriliza@on. The DynaNail
Deployment Frame and Ancillary Surgical Instruments must be placed in the
designated loca@on within the DynaNail Instrument Caddy. Do not add other
instruments to the DynaNail Instrument Caddy that are not part of the standard
configura@on supplied by MedShape. Do not stack the DynaNail Instrument Caddies
during steriliza@on.
Moist heat/Steam is the only method that has been validated for reprocessing by
MedShape. Sterrad or hydrogen peroxide based gas systems have not been validated.
Gravity displacement steriliza@on is not recommended due to extended cycle @mes.
Recommended Steam SterilizaMon Parameters
Time and temperature parameters required for steriliza@on vary according to type of
sterilizer and cycle design. Please review the instruc@ons of the sterilizer,
manufacturer, or healthcare facility procedures prior to steriliza@on.
Cycle Type
Prevacuum/Pulsa@ng
Vacuum/Flash Autoclave
Minimum Temperature
1
132° C to 135° C
(270° F to 275° F)
Minimum Exposure Time
2,3
Wrapped 4
Minimum
Drying Time
4 minutes 30 minutes
1
1. AAMI/AORN steam steriliza@on cycles with cycle @mes longer than
those listed are also acceptable. In the US, users should only use
sterilizers and accessories (such as steriliza@on wraps, steriliza@on
pouches, chemical indicators, biological indicators, and steriliza@on
containers) that have been cleared by the US FDA for the selected
steriliza@on cycle specifica@ons (132°C, 4 minutes).
2. FDA-cleared medical grade steam steriliza@on compa@ble wrap
that has been validated to allow sterilant penetra@on and to
subsequently maintain sterility.
3. Rigid steriliza@on container that complies with ANSI/AAMI ST46.
4. Drying @mes vary according to load size and should be increased
for larger loads.
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.