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37 | | MAQUET Medical Systems USA | ENDOSCOPIC VESSEL HARVESTING |
VASOVIEW 7 | Training Manual | English | v1
Copyright MAQUET Gmbh
VASOVIEW 7 xB Endoscopic Vessel Harvesting System
caution: Federal (USA) law restricts this device for sale by, or on the order of, a physician.
important: These Instructions for Use are designed to assist in the use of the VASOVIEW 7 xB
Endoscopic Vessel Harvesting System. They are not a reference to endoscopic surgery or tech-
niques.
indicaTiOnS: The VASOVIEW 7 xB Endoscopic Vessel Harvesting System is indicated for use in
minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for pa-
tients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and con-
trolling bleeding through coagulation, and for patients requiring blunt dissection of tissue including
dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and
other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity
procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coro-
nary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary
artery bypass grafting. Thorascopic procedures include exposure and dissection of structures
external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
cOnTraindicaTiOnS:
The VASOVIEW 7 xB Endoscopic Vessel Harvesting System is contraindi-
cated in situations where minimally invasive surgery is contraindicated.
WarningS and prEcauTiOnS: 1) Read all instructions carefully. Failure to properly follow the
instructions, warnings and precautions may lead to serious surgical consequences or serious injury
to the patient. 2) Minimally invasive surgical procedures should be performed only by individuals
adequately trained and familiar with such surgical techniques. Consult medical literature regarding
techniques, complications, and hazards prior to performance of these procedures. 3) Sterility: The
VASOVIEW 7 xB system is sterile unless the package is damaged or opened. The method of steri-
lization is gamma irradiation. The VASOVIEW 7 xB system is designed for single use. Do not reuse
or resterilize. 4) Before endoscopic instruments and accessories from different manufacturers are
employed in a procedure, verify compatibility and ensure that electrical isolation and grounding of
these instruments is not compromised. 5) A thorough understanding of the principles and tech-
niques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both
the patient and operator(s) and damage to medical instrumentation. 6) The VASOVIEW 7 xB Endo-
scopic Vessel Harvesting System is for use with the bipolar outputs of electrosurgical generators
only! 7) FOR INTERMITTENT OPERATION ONLY: Do not apply continuous cautery energy. 8) Do not
exceed 30 watts in any mode. 9) Use generators listed in the specified Mode and Setting Range
only. 10) Do not use with Codman Malis generators. 11) Handle the Endoscope carefully to avoid
breakage. Regularly check the orientation of the camera before advancing. 12) To avoid damage to
delicate tissue, advance the cannula gently. 13) Always advance the C-Ring and BiSECTOR™ tool
under endoscopic visualization. Ensure adequate visualization of BiSECTOR ends and surgical site
prior to application of electrosurgical energy. 14) Always inspect the surgical site for hemostasis.
If hemostasis is not present, appropriate techniques should be applied to achieve hemostasis. 15)
In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approx-
imately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is
signaled by cardiovascular collapse (sudden, severe hypotension) and a precordial murmur. If gas
embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a
left lateral and a slight Trendelenburg position. 16) When performing radial artery harvesting, the
radial artery harvesting procedure should be performed prior to placing the patient on cardiopul-
monary bypass. 17) Do not touch the coagulating surfaces while the device is activated. This may
cause injury.
VASOVIEW Short Port Blunt Tip Trocar (BTT)
caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
important: These Instructions for Use are designed to assist in the use of the Short Port Blunt Tip
Trocar (BTT). They are not a reference to endoscopic surgery or techniques.
indicaTiOnS: The VASOVIEW Short Port BTT has applications for surgery in the saphenous vein
or radial artery for establishment of a port of entry for endoscopic instruments.
cOnTraindicaTiOnS: The VASOVIEW Short Port BTT is contraindicated in situations where mini-
mally invasive surgery is contraindicated.
WarningS and prEcauTiOnS: 1) Sterility: The product is sterile unless the package is dam-
aged or opened. The method of sterilization is gamma irradiation. The product is designed for sin-
gle use. Do not reuse or resterilize. 2) Balloon products must be treated with care. Damage to the
balloon by instruments used during insertion and in the course of a procedure may result in balloon
rupture. 3) The Short Port BTT balloon contains natural rubber latex that is encapsulated by a sili-
cone coating such that latex is not intended to come in contact with the patient or the user. If the
outer layer of the balloon on the Short Port BTT is damaged, natural rubber latex may be exposed.
Natural rubber latex may cause allergic reactions. 4) Overinflation of the Short Port BTT balloon
may result in balloon rupture. Do not inflate with more than 25 cc of air.
7 mm Extended Length Endoscope and Dissection Tip
caution: Federal (USA) law restricts this device for sale by, or on the order of, a physician.
indicaTiOnS: The VASOVIEW 7 mm Extended Length Endoscope with Dissection Tip is indicated
for visualization of a surgical cavity and dissection in endoscopic procedures and other minimally
invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for
patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients
requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and tho-
racic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous
vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use
in coronary artery bypass.
cOnTraindicaTiOnS: The 7 mm Extended Length Endoscope and Dissection Tip is contraindi-
cated in situations where minimally invasive surgery is contraindicated.
WarningS and prEcauTiOnS: 1) The Endoscope is a reusable instrument that is supplied
non-sterile. Thoroughly clean and sterilize the Endoscope prior to each use. Follow recommended
cleaning and sterilization instructions. 2) The Endoscope is a fragile instrument. Handle carefully
to avoid breakage. Bending of the Shaft or dropping the Endoscope may damage the optics or
other internal components, making the Endoscope inoperable. Store in a protective tray whenever
possible. 3) The Dissection Tip is sterile unless the package is opened or damaged. The Tip is de-
signed for single use. Do not reuse or resterilize the Dissection Tip. 4) Whenever using endoscopic
illumination equipment, ensure that the light cable connectors never rest on flammable materials
such as surgical drapes, towels, etc. 5) If Prevacuum or Gravity steam sterilization (autoclave) are
used, the Endoscope may have a shorter life due to harsher sterilization environment. Inspect the
Endoscope after each steam sterilization cycle for damage. 6) Do not cool a hot Endoscope after
sterilization by rapidly exposing it to air or liquid. Sudden temperature changes may cause glass
components to crack. 7) Do not “flash” steam sterilize (autoclave) the Endoscope. Flash (i.e.,
unwrapped) steam sterilization cycles introduce sudden temperature changes, which may cause
glass components to crack.
This document is not intended to replace the Instructions for Use. Please refer to the full Instruc-
tions for Use for more detailed information.