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ENGLISH
DePuy Mitek VAPR
®
3.5mm 90° Suction
Electrode; LDS (Large Diameter
Suction) Electrode; LPS (Low Profile
Suction) Electrode: VAPR S
90
Electrode;
VAPR S
50
Electrode; VAPR Premiere50
Electrode; VAPR Premiere90 Electrode
INSTRUCTIONS FOR USE
Please read all information carefully, in particular the user
manual provided with the DePuy Mitek VAPR generator,
prior to use. The components of the DePuy Mitek VAPR
systems 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 Electrosurgical System is
designed for arthroscopic surgical procedures. The
system consists of a high frequency electrosurgical
generator, a reusable handpiece with connector cable,
disposable electrodes, alternative disposable electrodes
with integrated connector cable, and a foot switch. 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 systems.
DEVICE DESCRIPTION
The VAPR Suction Electrodes are soft tissue ablation
and desiccation devices intended for use with the VAPR
system. They extend the utility of the system by removing
bubbles created during activation from the operating site.
INDICATIONS
The DePuy Mitek VAPR Electrosurgical System is
intended for resection, ablation, excision, hemostasis of
blood vessels, and coagulation of soft tissue in patients
requiring arthroscopic surgery of the knee, shoulder,
ankle, elbow, and/or wrist.
CONTRAINDICATIONS
The DePuy Mitek VAPR Electrosurgical System is
contraindicated in any non-arthroscopic surgical
procedure and in any arthroscopic procedures where
saline or Ringer’s Lactate is not used as an irrigant. Use
of the system is also contraindicated in patients with
heart pacemakers or other electronic device implants,
or for patients for whom arthroscopic procedures are
contraindicated for any reason.
WARNINGS
1. The operator should be experienced in arthroscopic
surgical techniques.
2. Please refer to the user manual for step-by-step
instructions regarding the assembly and initial system
check of the DePuy Mitek VAPR system.
3. Ensure that fluid inflow is adequate and that the
electrode is activated only when surrounded by
conductive irrigant solution (e.g., saline or Ringer’s
Lactate). The use of RF energy with inadequate
irrigation may overheat the fluid enough to cause skin
burns at or near the access site and may result in
damage to the electrode tip assembly.
4. Do not touch the electrode tip when power is
being applied.
5. Do not withdraw or insert the electrode when power is
being applied.
6. Avoid unnecessary and prolonged activation of the
electrode between tissue applications. Failure to do
so may result in unintended injury.
7. Do not reuse any accessories labeled as SINGLE USE.
This product is for single use only. It has not been
designed to be re-used/re-sterilized. Reprocessing may
lead to changes in material characteristics such as
metallic corrosion and dulled edges, ceramic and plastic
deformation or splitting which may impact the strength
of the device and compromise device performance.
Reprocessing of single-use devices can also cause
cross-contamination leading to patient infection. These
risks may potentially affect patient safety.
