System Description; Device Description - DePuy Mitek VAPR COOLPULSE 90 Manual Del Usuario

ENGLISH
DePuy Mitek VAPR
COOLPULSE
INSTRUCTIONS FOR USE
Please read all information carefully, in particular the
user manual provided with the DePuy Mitek VAPR
VUE™ Radiofrequency (RF) System, prior to use. The
components of the DePuy Mitek VAPR VUE system
are designed for use as a single system. Failure to
follow instructions may lead to improper functioning of
the device and cause electrical or thermal injury.

SYSTEM DESCRIPTION

The DePuy Mitek VAPR VUE Radiofrequency (RF)
System is designed for arthroscopic surgical
procedures. The system consists of a high frequency
electrosurgical generator and may include a reusable
handpiece with connector cable and disposable
electrodes, alternative disposable electrodes with
integrated connector cable, also available with hand
controls, a footswitch, and a wireless footswitch
alternative. The components are designed and
intended to be operated as a single unit. Use only
DePuy Mitek VAPR electrodes and accessories with
DePuy Mitek VAPR VUE RF system.

DEVICE DESCRIPTION

The VAPR Electrodes are soft tissue ablation and
hemostasis / coagulation devices intended for use
with the VAPR VUE RF System. The VAPR
COOLPULSE
which will enhance the efficiency of the electrode and
extend the utility of the system by assisting in the
removal of bubbles and debris created during
activation within the operating site.
INDICATIONS
The DePuy Mitek VAPR Electrodes for use with the
VAPR VUE Radiofrequency System are intended for
resection, ablation and excision of soft tissue,
hemostasis of blood vessels and coagulation of soft
tissue in patients requiring arthroscopic surgery of the
knee, shoulder, hip, ankle, elbow, or wrist.
CONTRAINDICATIONS
The DePuy Mitek VAPR Electrosurgical System is
contraindicated in:
• any non-arthroscopic surgical procedure.
• any arthroscopic procedures where saline or
Ringer's Lactate is not used as an irrigant.
• patients with heart pacemakers or other electronic
device implants.
• patients for whom arthroscopic procedures are
contraindicated for any reason.
WARNINGS
• The operator should be experienced in arthroscopic
surgical techniques.
• Please refer to the user manual for step-by-step
instructions regarding the assembly and initial
system check of the DePuy Mitek VAPR VUE
system.
• As with all electrosurgical devices, do not use in the
presence of flammable anesthetics, oxidizing gases
or other flammable substances, as an electro-
surgical device has the potential for providing a
source of ignition.
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90 Electrode has suction capabilities
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90 Electrodes
1
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