PFM Medical TiLOOP Notice D'utilisation page 15

Recommended procedure for a SAL of ≥ 10
• Steam sterilisation using saturated steam with fractionated vacuum.
• Temperature: 134 °C
• Holding time: 5 min.
• Vacuum: ­ 80 kPa
• Drying time: 15 min.
Following sterilisation, check the sterile goods packaging for damage, check sterilisation indicators.
Storage
• Store sterilised TiLOOP® Instruments in sterile goods packaging in a closed cabinet, protected from
dust, moisture and temperature fluctuations.
• The permissible storage duration depends on the type of sterile goods packaging that is used. The
permissible storage duration is to be stipulated by the preparer.
Transport
• The instruments are to be transported in a closed container so as to protect the instruments and the
sterile materials packaging.
Disposal
• After cleaning and disinfection, defective or obsolete instruments are to be disposed of.
• All components supplied with the product and any instruments that are possibly not used and such
as are used are to be handled and disposed of carefully conform with the standard hospital rules and
the national and regional laws and regulations. Components that are supplied together with the
product could be packaging and instructions for use, for example. Special attention is to be paid to
the special hazardous waste requirements in the case of infectious waste.
Miscellaneous
• The patient is to be informed of the warnings, precautions, contraindications and possible complica-
tions that concern her.
• All serious events that occur in connection with the product are to be reported to the manufacturer
and the responsible national authority.
Warranty
• The products are made of high-quality materials conform with DIN EN ISO 7153-1 and they are sub-
jected to a quality control before delivery. If you should experience any defects, however, please con-
tact our Customer Service.
• pfm medical titanium gmbh shall be liable solely for direct damages to TiLOOP® Instruments and
accepts no liability if these instructions for use have been verifiably violated.
MK-E000620_09 / 2021-02-01
:
-6
2100616
English
15