Indications For Use - Olympus CelonLab ENT Instrucciones De Uso

Instructions for Use
Caution: The CelonLab
(electromagnetic compatibility) standard. Nevertheless, when the power
control unit is active it may disturb neighbouring electronic equipment. Please
follow the
electromagnetic ambient conditions ("EMC Guidelines").
Caution: Mobile communication equipment (e.g. mobile phones) may disturb
the functioning of the power control unit and other electrical medical
equipment.
Caution: Contact with the tip of the coagulation electrodes may cause burns
when the power control unit is active.
Caution: In the event of a defect or malfunction in the unit, an undesirably
high output power may be emitted.
Caution: When the housing is opened there is a danger of electric shock. The
unit must only be serviced by authorised technicians.
Caution: Federal Law of the USA restricts this device to use by or on the
order of a physician.
2. Description

2.1 Indications for Use

The system, comprising the CelonLab
electrodes, is indicated for ablation and coagulation of soft tissue in
otorhinolaryngology (ENT) surgery. This method of treatment is also referred to
as bipolar radiofrequency induced thermotherapy (RFITT).
2.2 Contraindications
Electrosurgical interventions are contraindicated if, in the judgment of the
physician, tissue coagulation could have a negative effect on the state of the
patient. Radiofrequency induced coagulation may be contraindicated for patients
with a weakened immune system.
2.3 Features of the Unit
The CelonLab
coagulation electrodes via its bipolar output. A neutral electrode (return
electrode) is not necessary.
The power control unit features clearly laid out controls. After switching on the
unit, the user only has to select the power level and activate the power output
using the footswitch.
The power control unit provides an acoustic output of the coagulation status.
With CelonLab
frequency with conventional radiofrequency generators, is designed so that its
frequency is proportional to the tissue resistance at any particular moment. This
permits acoustic monitoring of the coagulation status, since the latter is directly
connected with the tissue resistance. If the resistance increases beyond a
specific limit value, which means that the coagulation process has ended, this is
indicated by the tone being pulsed.
W7098046
EN
ENT
power control unit complies with the EMC
instructions in the
ENT
power control unit supplies the compatible bipolar
ENT, the "generator active" signal, which usually has a fixed
technical documentation
ENT
and compatible coagulation
ENT
CelonLab
regarding
5