Intended Use Of The Curis; Contraindications And Side Effects; Contraindications; Side Effects - Sutter Curis Gebrauchsanweisung

2.2 Intended use of the CURIS

The CURIS radio frequency device with its output power of max. 100 watts is suitable for
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monopolar and bipolar electrosurgical procedures in neurosurgery, ear, nose, and throat medicine,
plastic/cosmetic surgery, oral and maxillofacial surgery, dermatology, and by registered surgeons.
Meaningful applications may exist in other specialist fields.
The CURIS is suitable for electrosurgical cutting and coagulating.
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Exclusions are application immersed in liquids and applications that require a higher RF output
than the maximum output specified in the technical data for the respective current type.
The CURIS may only be used by persons that have been trained in the proper and safe use of the
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device. The instructions for use must be observed for training and application.
The safe application of electrosurgery requires the user to be familiar with the technology and forms
of application.
Any change to the product or deviation from these instructions for use waives the liability
of Sutter Medizintechnik.

2.3 Contraindications and side effects

2.3.1 Contraindications

Applications that require a higher RF output than the maximum output specified in the technical
data for the respective current type are contraindicated.
In case of procedures on body parts with a small cross-section in proportion to their dimensions
(filamentary structures and skin flaps), using bipolar technology or forgoing the use of RF surgery
may be necessary to prevent unwanted coagulation in other areas.
No contraindications that apply to the product directly are known at this time. The attending doctor
has to decide whether the intended application can proceed, based on the patient's general
condition. The safety measures described in section 7 have to be observed in addition.

2.3.2 Side effects

No side effects that apply to the product directly are known at this time. Observe the safety
measures in order to avoid unwanted effects – see section 7.
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CURIS Instructions for Use
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