Indications; Safety; Warnings; Precautions - smith&nephew VERSAJET II Manual De Instrucciones

EN

Indications

The VERSAJET II Hydrosurgery System is intended
for wound debridement (acute, chronic wounds and
burns), soft tissue debridement and cleansing of the
surgical site in applications that, in the physician's
judgment, require sharp debridement and pulsed
lavage irrigation.

Safety

The VERSAJET II system is designed for use by
qualified and trained medical professionals. It is
recommended to study this user guide, paying
particular attention to all Warnings and Precautions,
prior to any surgical procedure. Improper system
use or set up, or failure to follow this user guide
may cause injury or damage not covered under the
warranty.

Warnings

• This device should be used with particular care
in patients with hemophilia or other blood clotting
disorders and in patients receiving anti-coagulant
medication.
• This device can cut soft tissue. Apply only to
tissues and debris intended to be excised from the
wound.
• This device is not suitable for use in the presence
of a flammable anaesthetic mixture with air or
oxygen.
• Increasing console power settings will lead to
more aggressive tissue removal. Use caution
near delicate vessels and structures, such as
neurovascular bundles.
• The VERSAJET II handpieces are designed for
connection only to the VERSAJET II system
console. DO NOT attempt to connect to any other
equipment.
• The VERSAJET II Plus handpieces provide more
aggressive debridement and excision when
compared to the VERSAJET II Exact handpieces.
VERSAJET II Plus is appropriate for wounds that
require aggressive, yet selective, removal of tissues
that are tough, heavily necrotic, contaminated or
burnt. Users should be aware that just as with
any sharp instrument, care and attention must
be maintained while using the VERSAJET II Plus
handpieces near delicate vessels and structures.
• VERSAJET II is intended primarily for use in the
operating room environment. Only the 45 degree
VERSAJET II Exact handpieces (66800041 and
66800042) are suitable for use outside the
operating room. Attention to universal infection
control procedures should be applied when using
the device outside the controlled environment of
the operating room.
• The 15 degree, 14mm VERSAJET II Exact handpiece
(66800040) and all of the VERSAJET II Plus
handpieces (66800043, 66800044 and 66800045)
should not be used outside the operating room due
to the potential of excessive misting or spraying.
• If the VERSAJET II Exact 45 degree handpieces are
used outside the operating room, ensure the floor
immediately surrounding the treatment area is
covered and any splashes cleaned after treatment
is complete.

Precautions

• Always begin debridement procedures at the
lowest power setting and increase as necessary
to the optimal setting for the type of tissue being
debrided to avoid unintended tissue removal.
• In order to avoid unwanted procedural delays,
assure the system is fully operational prior to
administration of anesthesia.
• When used on wounds where bone, tendon or
other hard tissue may be encountered during the
debridement procedure, excessive spraying and/
or misting may occur due to the interruption of the
stream of sterile saline by hard tissues.
• Spraying or misting is more frequent at lower power
settings due to less pressure. Spraying or misting
may be reduced by keeping the waste evacuation
tube straight.
• As with all surgical procedures, the VERSAJET II
operator and other clinical personnel should follow
the universal precautions for infection control
(including the use of surgical gloves, facemask that
covers the mouth and nose, protective eye goggles,
protective clothing and anti-slip shoe covers).
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