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SAFETY INFORMATION

 

Aesthetic

 

CO2 Products

 

CO2 lasers are intended solely for use by physicians trained in the use of the Carbon Dioxide laser (10.6 μm) wavelength. Incorrect treatment settings or misuse of the technology can present risk of serious injury to patient and operating personnel. Risks that may be associated with any CO2 laser procedure may include change of pigmentation, infection, erythema, skin induration or scarring. Read and understand the CO2 systems and accessories operator manuals for a complete list of intended use, contraindications and risks. The use of Lumenis CO2 laser is contraindicated where a patient has taken Accutane (Isotretinoin) within the past 6-12 months, has a history of keloid formation and demonstrate excessive or unusually prolonged erythema.

 

M22

 

M22 is contraindicated for patients with active infection, viral, fungal or bacterial diseases. The use of M22 could cause redness, swelling, scarring, change of pigmentation. See the system user manual for a complete list of contraindications and risks.

 

LightSheer

 

Treatment should not be attempted on patients with the following conditions in the treatment area: any active infections or inflammatory skin conditions, Dysplastic nevi, tattoos, active cold sores, open lacerations or abrasions, viral, fungal, or bacterial diseases or a history of post inflammatory hyperpigmentation. The most common immediate responses of laser treatment for hair removal, vascular lesions, pigmented lesions are erythema, edema, perifollicular edema and perivascular edema, vascular bleaching, hyperpigmentation and hypopigmentation or textural changes of the treated areas. The complete list of contraindications and risks can be found in the LigthSheer system user manual.

 


 

Surgical

 

CO2 Products

 

CO2 lasers (10.6 µm wavelength) are intended solely for use by trained physicians. Incorrect treatment settings or misuse of the technology can present risk of serious injury to patient and operating personnel.

The use of Lumenis CO2 laser is contraindicated where a clinical procedure is limited by anesthesia requirements, site access, or other general operative considerations. Risks may include excessive thermal injury and infection.

Read and understand the CO2 systems and accessories operator manuals for a complete list of intended use, contraindications and risks.

 

Holmium Products

 

The use of the Lumenis Pulse™ and VersaPulse® PowerSuite™ laser systems and delivery devices in urology is contraindicated for patients who are unable to receive endoscopic treatments or are intolerant to prolonged anesthesia, as well as for resection or excision of large vascularized organs.

Holmium lasers are intended solely for use by physicians trained in the use of the Ho:YAG (2.1 μm) wavelength. Incorrect treatment settings can cause serious tissue damage. The laser should be used only on tissues that are fully observable.

See the system’s user manual for a complete list of contraindications and risks.

 

Morcellator

 

The use of the Lumenis VersaCut is contraindicated for:

  • Morcellation of bone and for use in liposuction procedures.
  • Gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
  • Removal of uterine tissue containing suspected fibroids in patients who are: Peri- or post-menopausal, or Candidates for en bloc tissue removal, for example, through the vagina or via a mini-laparotomy incision.

Lumenis VersaCut is intended solely for use by physicians trained in the use of the VersaCut morcellator. Use extreme caution when first using the instrument in a clinical setting, particularly when operating in proximity to critical anatomical structures.

Potential complications include:

  • Unintended morcellation of non-target tissues.
  • Postoperative infection.

The Lumenis VersaCut should only be used under direct or endoscopic visualization in a fluid environment.

See the system user manual for a complete list of contraindications and risks.

 


 

Ophthalmology

 

Retina Family

 

Lumenis photocoagulators and delivery devices are intended solely for use by trained physicians. It is contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

 

Retina Products

 

Smart 532/ Spectra/ Array/ Vision One is intended solely for use by trained physicians. It is contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

 

Glaucoma Family

 

SLT: Lumenis SLT devices are intended solely for use by trained physicians. It is contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. Refer to the operator manual for a complete list of intended use, contraindications and risks.

YAG: Lumenis YAG devices are intended solely for use by trained physicians. It is contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Refer to the operator manual for a complete list of intended use, contraindications and risks.

 

Glaucoma Products

 

Selecta II

Selecta II is intended solely for use by trained physicians. It is contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. Refer to the operator manual for a complete list of intended use, contraindications and risks.

Smart Selecta Duet

Selecta Duet is intended solely for use by trained physicians. SLT: contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. YAG: contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Refer to the operator manual for a complete list of intended use, contraindications and risks.

Smart Selecta Trio

Smart Selecta Trio is intended solely for use by trained physicians. SLT: contraindicated for eyes with neovascular or angle-closure glaucoma. Risks include iritis, conjunctivitis and IOP rise. YAG: contraindicated for eyes with corneal pathologies and chronically elevated IOP. Risks include IOP rise, macular edema and retinal detachment. Smart 532: contraindicated for eyes with severe media opacities. Risks include increased macular edema and bleeding in areas of neovascularization. Refer to the operator manual for a complete list of intended use, contraindications and risks.

 

M22

 

M22 is contraindicated for patients with active infections, dysplatic nevi, or tattoos in the treatment area. Risks include redness, swelling, scarring, and change of pigmentation. Refer to the operator manual for a complete list of intended use, contraindications and risks.