Greenlight XPS - Spinal Surgery Complications; Plastic Surgery Complications; Thoracic Surgery Complications; Urology Complications

Process Black ΔE ≤5.0 / CMYK Image
8
Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0
Spinal Surgery
See Adverse Events for general information. Some patients have reported an inflammatory response four to ten days post-operative at the site of
surgery. This has occurred in patients who have reported a successful procedure post-operatively and are otherwise asymptomatic.
The occurrence of this adverse event has reportedly been significantly reduced by the administration of an anti-inflammatory agent, into the
surgical site, at the completion of the procedure.
With surgical procedure in the spine, there is the potential risk of infection, inflammation and post-operative pain. The injection of antibiotics, anti-inflammatory
drugs, and analgesics into the surgical area at the completion of the procedure has been reported to reduce the occurrence of these adverse events.
See Contraindications for general information. General anesthesia is specifically contraindicated for this procedure.
This procedure is contraindicated, if the following conditions exist:
• Non-containeddischerniation(leakageofdyeintoepiduralspacebydiscogram)
• Radiographicevidenceofspinalstenosis>50%
• Progressiveneurologicalloss
• CaudaEquinaSyndrome
• Tumor
• Infection
• Fracture
• Spondylolisthesis
• Spinalinstability
• Freefragmentsorothersignificantpathologies
• Significant(>30%)narrowingofdiscspace,possiblefacetdamage
• Patientswithprevioussurgery/chemonucleolysisattheindicatedlevelmaybeacandidateforlaserdiscdecompression.
• Allotherfactorsshouldbeconsidered.
Plastic Surgery
The laser is not intended for use for skin incision or liposuction. See Adverse Events for general information. Initial skin incision using the laser
may result in undesirable scar formation.
See Contraindications for general information. There are no known contraindications unique to plastic surgery.
Thoracic Surgery
The use of contact delivery devices (for example, sculptured fibers) on lung tissue, in conjunction with the wavelength, is considered investigational.
When performing thoracoscopic surgery it is vital for the surgeon to appreciate that the view provided is monocular (not binocular) and that depth
perception is decreased. Practice on the part of the surgeon to get the feel of operating through a monocular scope is strongly recommended
before clinical use.
In surgery of a body cavity that is insufflated, the surgeon and the anesthesiologist must appreciate the risk of embolism, should a blood vessel be
opened. Most surgeons prefer CO2 as the pressurizing gas of choice, as it is readily absorbed and does not lead to embolism. The anesthesiologist
should monitor the patient for unusually high CO2 absorption, and adjust procedures, as necessary.
See Adverse Events for general information. There are no known specific complications and risks to thoracic surgery use at this time.
See Contraindications for general information. There are no known contraindications unique to thoracic surgery.
Urology
See Adverse Events for general information.
7 HOW SUPPLIED
Donotuseifthepackageisopenedordamaged.
Donotuseiflabelingisincompleteorillegible.
7.1 Handling and Storage
• Storageandtransporttemperaturewithallwaterdrainedfromthesystem:32°Fto104°F(0°Cto40°C)
• Storageandtransporttemperaturewithcoolingsystemchargedwithdistilledordeionizedwater:39°Fto104°F(4°Cto40°C)
• Storeinadryplace
When in storage or transport outside of the recommended temperature ranges, damage may occur to the cooling system, optical resonator, and other
critical components. The console should be drained using the field drain procedure. For complete draining procedure, contact BSC technical support.
When the console is drained and in storage, the desiccant pack should be replaced on a six-month interval.
8 SAFETY
8.1 Eye Injury
Visible light laser energy passes through the transparent components of the eye (cornea, lens, aqueous, and vitreous humor), and is focused on the
retina. This light can cause an accidental retinal burn. The degree of injury to the eye will depend upon the power of the beam, how focused the
beam is, and how long the eye is exposed to the beam.
Protective eyewear for the operating room staff and patient should be provided. Laser eyewear may not be interchangeable between lasers of
different wavelength, power, or divergence angle.