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Safety information
2 Safety information
This chapter provides general safety information for using the product. The safety
information includes:
‒ Intended purpose
‒ Manufacturer information
‒ General safety notes
2.1 Intended purpose
2.1.1 Intended use and indications
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary
equipment, is intended for cutting and coagulation of tissue in the following medical elds:
‒ Open surgery
‒ Laparoscopic surgery
‒ Endoscopic surgery
Only for use by a qualied physician in an adequate medical environment.
2.1.2 Contraindications
Absolute contraindications
There are no absolute contraindications.
Relative contraindications
At the discretion of the physician, electrosurgical procedures can be contraindicated under
the following circumstances:
‒ If tissue coagulation and cutting can have a negative effect on the state of the patient.
‒ For patients with implanted electronic devices, e.g. cardiac pacemaker, cardioverter
debrillators.
‒ For patients with a weakened immune system.
‒ For patients with blood coagulation disorders.
2.1.3 Patient target group
Not dedicated to a specic patient population. Patient target groups are dened by the
individual applicator used with the device.
2.1.4 Intended users
Medical use
Only for use by a qualied physician or medical personnel under the supervision of a
physician.
Only for use in an adequate medical environment.
These instructions for use do not explain or discuss clinical procedures.
Reprocessing
Reprocessing of reusable products may only be performed by qualied hygiene personnel.