Bowa ARC 400 - Safety; Intended Use

2 Safety
BOWA-IFU-11779-ARC400-V2.1.0-S0-EN Operating Manual ARC 400 11
2. Safety
2.1. Intended use
The HF device is intended exclusively for the generation of electrical power
for monopolar and bipolar cutting and coagulation on tissue structures in
surgical operations.
It is used in the following areas:
 General surgery
 Endoscopy (GastroCut mode)
 Gynecology
 Hand surgery
 ENT
 Cardiac surgery (including open-heart surgery)
 Neurosurgery
 Pediatric surgery
 Plastic surgery and dermatology
 Thoracic surgery
 Orthopedics
 Urology, including transurethral resection (TUR)
Do not use the HF device if, in the opinion of an experienced physician or
according to current professional literature, such use would endanger the
patient, due for example to the general condition of the patient, or if other
contraindications are present.
BOWA requires that the HF device is operated under the supervision of
qualified and authorized personnel. The surgeon and medical staff must be
trained in the fundamental principles, rules for use and risks of HF surgery
and must be familiar with these in order to safely and reliably prevent putting
patients, staff and equipment at risk.
Contact your BOWA distributor for trainings and training material.
Any other use is neither intended nor proper and must be effectively
prevented.
When setting up the HF device, ensure easy access to the power cable so it
can be disconnected from the device.
(IEC 60601-1:2012, Section 7.9.2.7)