Sterilization; Before Sterilization - KLS Martin smartPen MD 62 Gebrauchsanweisung

Instructions for Use
Monopolar electrode handle smartPen
5.6

Sterilization

5.6.1

Before Sterilization

•
Ensure that the smartPen has been cleaned.
•
Intactness of the insulation, cleanliness and integrity of the instrument must be visually ascertained.
•
The active electrode must have been removed from the smartPen!
•
Repeat the cleaning if a visual check reveals tissue residues on the smartPen, or if the active electrode
is still in the smartPen, see section 5.4 "Manual prewash", page 50.
•
Properly pack the smartPen according to ISO 11607 and EN 868 in order to maintain the sterile barrier
after removal from the sterilizer.
•
Please follow the recommendations of the manufacturer of the sterilizer as regards handling, loading
and parameter setting.
• Sterilization at high temperatures or long sterilization times reduces the lifespan of the instruments.
Risk of infection in case of non-sterile handling!
Improper sterilization and non-sterile handling of the instruments can entail severe health risks for the
patient.
•
The active electrodes must be properly protected so that the sterile barrier is not damaged.
•
In case of return shipments, send only clean and disinfected products in sterile packing.
•
Always sterilize the active electrode and smartPen separately.
•
Sterilization must be done using a validated steam sterilization method, e.g. in a sterilizer according to
EN 285:2009 and validated according to ISO 176651:2006.
•
The operator must ensure that sterility is maintained after the sterilization process.
•
Use appropriate and approved sterilization packaging (e.g. in accordance with EN 868, ISO 11607) or
sterilization containers for storage and transport.
Risk of infection and risk of damage in case of impermissible sterilization!
Impermissible sterilization can lead to severe health risks for the patient and damage to the smartPen.
•
Do not sterilize the smartPen with hot air or flash autoclaving methods.
•
Do not use any plasma sterilization methods (NTP Sterilization)!
Revision 04 53