Menu
Place clean and dry products (handpieces, attachments, sterilization guides) into designated locations in the sterilization container. Fasten sterilization case lid.
Sterilization Container Dimensions: 425 mm (Length) x 305 mm (Width) x 120 mm (Height)
WARNING: Instruments are manufactured as non-sterile. They need to be sterilized before using.
CAUTION: ACF Medical recommends you to autoclave your tools and accessories in ACF sterilization container. Every instrument should be sterilized independent of each other.
1. The most effective and safe sterilization method is steam sterilization for Sign Modular Surgical Power Tool System. The instruments are capable of withstanding the recommended exposure times and temperatures of steam sterilization. Other sterilization methods are not recommended.
2. Sterilization must be carried out through a validated steam sterilization process (according to ISO 17665-1:2006).
In case of any urgent need;
a. Instruments can be sterilized with parameters of 134° C program for a minimum holding time of 4 minutes as can be seen below. For normal operation procedures, validated steam sterilization process should be followed.
b. Sterilized instruments should be used not long after sterilization. Steam autoclave should be in the most closest location to the operating room and/or sterilized instruments should be transported to the point of use under aseptic conditions.
c. Quality controls should be recorded such as all indicator results, emergency reasons and patient information.
Parameters for Sterilizing
WARNING: Power tools and attachments need to be sterilized, before every surgical procedure, passing to a service area, returning to the supplier or manufacturer.
CAUTION: The following value must not be exceeded for sterilizing: 134° C. Higher values can damage the sterilized products.
CAUTION: Do not use the handpiece just after autoclave process till temperature of trigger mechanism to cool down and reach to room temperature. If you use it before cooling; handpiece will be damaged.
CAUTION: Do not soak device to cool them down or wrap liquid sterilant around them. Do not accelerate the cooling process as it will damage the electronic components of the power tool and could result in harm to the user and patient.
WARNING: The principles of aseptic technic should be followed before/while using the tool.
Storage
Packaged and sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests, and extremes of temperature and humidity. Use products in the order in which they are received (first-in, first-out principle), taking note of any expiration date on the label.
CAUTION: In order to prevent any missing product in the set to be sterilized; be ensure that the set content is checked before sterilization process.
