Greenlight XPS - Contraindications; General Surgery Contraindications; Gastroenterology Contraindications; Gynecology Contraindications

4
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 ≤5.0Black (K) ∆E ≤5.0
• Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell
carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric
ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm,
angiodysplasia, polyps, ulcers, colitis, hemorrhoids).
• Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as endometriosis; cervical, vulvar, and
vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.
• Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
• Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm texturedtype.
• Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.
• Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
• Spinal Surgery: Percutaneous lumbar discectomy.
• Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoracoscopic
or open procedures.
• Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation,
vaporization, incision, excision, and coagulation of soft tissue) including treatment of bladder, urethral and ureteral tumors; condylomata;
lesions of external genitalia; urethral and penile hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate
tissue for men suffering from Benign Prostatic Hyperplasia (BPH).
The GreenLight XPS™ Laser System is intended for the hospital, office, and outpatient surgery center markets.
3 CONTRAINDICATIONS
The laser system is contraindicated for patients with the following conditions:
• Generalmedicalconditionthatcontraindicatessurgicalintervention
• Whenappropriateanesthesiaiscontraindicatedbypatienthistory
• Calcifiedtissue(especiallytumors)
• Hemostasisofvesselsoverapproximatelytwomillimetersindiameter
• Whenlasertherapyisnotconsideredthetreatmentofchoice
• Uncontrolledbleedingdisordersandcoagulopathy
• Prostatecancer
• Acuteurinarytractinfection(UTI)
• Severeurethralstricture
The GreenLight XPS Laser System is contraindicated in the presence of severe urethral strictures; however, the system can be used in the
treatment of urethral strictures with proper cautions. A severe stricture shows visible narrowing on urethrography or ultrasonography, with near
total obstruction that makes passage of instruments difficult or dangerous. Use caution to avoid injury to urethral tissue.
4 WARNINGS
• Everyoneintheroomisrequiredtowearprotectiveeyewear.
• Neveruseaclamptosecurethelaserfibertoadrape.Theuseofaclamptosecureafibermaycausethefibertobendatsharpangles,
which can damage the fiber, causing an unsafe condition. The fiber can break and release laser energy, causing a burn in the protective
jacket. If undetected, this condition will result in a burn or ignition of flammable materials.
• Donotfirethelaserunlesstheaimingbeamisvisibleanddirectedatthetargetedtissue.
• Neveractivatethelaserenergyunlessthefibertipextendsvisiblybeyondthetipoftheendoscope.
• Unauthorizeduseofinternalcontrols,adjustmentstotheequipment,orperformanceofproceduresotherthanthosespecifiedherein,may
result in hazardous radiation exposure.
• Warningsignsarenotinterchangeable.Selectasignthatisappropriateforthewavelengthsinuse.
• Whenusinganodized,blackchromefinished,orebonizedinstrumentsduringasurgicalprocedure,additionalcareshouldbetakento
prevent burns. These instruments will become extremely hot when they come in contact with a laser beam and are not able to dissipate
heat quickly. When tissue is touched under these conditions, a burn may result.
• Unauthorizedmodificationofthisequipmentisnotallowed.Donotattempttorepairoralteranycomponents/partsoftheGreenLightXPS
Laser System. All repairs and servicing are to be performed only by Boston Scientific Corporation (BSC) or personnel authorized by BSC.
5 PRECAUTIONS
• Beforeoperatingthelasersystem,surgeonsandallstaffoperatingthelasershouldcarefullyreadandbecomefamiliarwiththeUser’sManual.
• DonotattempttoturnonthelasersystemuntilithasbeeninstalledandtestedbyaBSCserviceengineer.Severedamagetothelaser
system may result.
• Alterationsinsurgicalapproachortechniquemayberequiredtoaccommodatelaseruse.
• Thelasersystemisasurgicaldeviceusedbysurgeonswhohavebeentrainedinlasersurgerythroughcourses,preceptorships,orunder
the guidance of other surgeons knowledgeable in laser use.
• Thesurgeonshouldbecomefullyacquaintedwiththeuniquesurgicaleffectsproducedwiththelasersystembeforeclinicaluse.These
effects include coagulation, depth of penetration, and cuttingintensity.