Idiomas disponibles
Idiomas disponibles
DISINFECTION, CLEANING AND STERILISATION
Operation
7
Packaging
8
Sterilization
END-IFU-CALAMUS-DUAL-V06-WEB-EUR-Multilingual-06-2022
Operating mode
• Place the devices
in a kit, support
or container
to avoid any
contact between
instruments or
posts and pack
the devices in
"Sterilisation
pouches".
• Steam sterilisation
at:134°C / 273°F
during 18 min.
• Pouched
Sterilization:
Place in an
appropriately sized
sterilization pouch
and seal it.
Standard
autoclaving
(Gravity
displacement
method)
a. Time: 15 min
b. Temperature:
132° C (270° F)
c. Dry time:
30 minutes
A3. Contra Angle
A2. Implantable devices
Following uses
A1. Instruments
First use
Warning
• Avoid any contact between
instruments or posts during
sterilization. Use kits, supports or
containers.
• Check the validity period of the
pouch given by the manufacturer
to determine the shelf life.
• Use packaging which are
resistant up to a temperature of
141°C (286°F) and in accordance
with EN ISO 11607.
• The instruments, posts and
the plastic supports must be
sterilized according to the
packaging labelling.
• Use only autoclaves that are
matching the requirements of
EN 13060, EN 285.
• Use a validated sterilisation
procedure according ISO 17665
• Respect the maintenance
procedure of the autoclave
device given by the
manufacturer.
• Use only this recommended
sterilization procedure.
• Control the efficiency (packaging
integrity, no humidity, colour
change of sterilisation indicators,
physico-chemical integrators,
digital records of cycles
parameters).
• Traceability of procedure records
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