Anthos SMART TOUCH R7, Руководство по эксплуатации

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88 EN
R7
- OPERATING INSTRUCTION
1.5. Sterilization
Each instrument is supplied NOT STERILE and must be sterilized in a steam autoclave (max 135°C) before use, avoiding any form of chemical
sterilization.
Sterilization must be performed using suitable packaging materials checked during the sterilization process validation.
We recommend sterilizing in steam autoclave (moist heat) using a pre-vacuum (forced air removal) cycle.
Autoclaves must comply with the requirements of, be validated by and maintained in accordance with EN 13060 (or ANSI/AAMI ST55), EN ISO
17665-1 and ANSI/ AAMI ST79.
See below for recommended minimum sterilization parameters for re-usable medical devices that have been validated to provide a 10^-6 sterility
assurance level (SAL):
• Cycle Type with pre-vacuum (Pre-vac).
• Method: "overkill" moist heat sterilization in compliance with ISO 17665-1.
• Minimum temperature: 134°C (273°F) for heat-resistant materials (instruments and metallic handpieces, etc); 121°C (250°F) for heat-labile materials
(rubber products, etc.).
• Minimum exposure time
(1)
: 4 minutes (at 134°C), 20 minutes (at 120°C).
• Minimum drying time
(2)
: defined to ensure compliance with the requirements of EN 13060 (or ANSI/AAMI ST55).
(1)
Exposure time: period of time during which the load and the entire chamber are maintained above sterilization temperature.
(2)
DRYING TIME: period of time during which steam is removed from the chamber and the chamber's pressure is reduced to allow evaporation of
condensate from the load either by prolonged evacuation or by the injection and extraction of hot air or other gases.
The drying time varies according to load configuration, type of packaging and materials.