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Indications, Safety, and WarningsIndications for useThe Visualase™ MRI-guided laser ablation system is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers.Intended useThe Visualase™ MRI-guided laser ablation system is intended to ablate, necrotize, or coagulate soft tissue under MRI guidance when data from compatible MRI sequences is available. The Visualase™ system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.The Visualase™ MRI-guided laser ablation system is compatible with MRI scanners listed in the “MRI scanner compatibility” section of the system manual. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase™ analysis.ContraindicationsThe Visualase™ MRI-guided laser ablation system is contraindicated for the following patients:

Patients who have medical conditions that are contraindicated for MRI

Patients who have implanted medical devices that are contraindicated for MRI

Patients whose physician determines that laser-induced thermal therapy (LITT) is not acceptable

Patients for which invasive surgical procedures in the brain is not appropriate

Warnings

Warning: Do not perform any assembly of the Visualase™ system. All assembly shall be done by Medtronic Navigation, Inc.

Warning: Do not use the Visualase™ system with an extension cord.

Warning: Do not connect items to the Visualase™ system that are not specified as part of the system.

Warning: Use the Visualase™ system only in an appropriate, dry area.

Warning: To avoid risk of electrical shock, the Visualase™ system must only be connected to a supply mains with protective earth.

Warning: Read all cautions and procedures in the accompanying Visualase™ cooled laser applicator system package insert before using any Visualase™ laser applicator.

Warning: Read all cautions and procedures in the accompanying Visualase™ software user manual before using the Visualase™ system.

Warning: Do not take any component other than the Visualase™ cooled laser applicator or MRI compatible accessories into the high-field region of the MRI magnet.

Warning: Do not attempt to lift or tilt the Visualase™ system. Damage to the system or harm to the operator may occur.

Warning: Do not modify the Visualase™ system.

Warning: The system and its associated applications should be used only by qualified medical professionals who are thoroughly trained and experienced in performing surgery with Visualase™ systems.

Warning: Inspect all system components before use. If visibly damaged, do not use the system.

Warning: Failure of the hospital IT system may cause loss of images to the Visualase™ system. Loss of images during therapy may result in unintended laser radiation.

Warning: To prevent potential latency issues caused by connecting to the hospital IT network, connect to the local host. Failure to connect to the local host may affect accuracy during the procedure.

Warning: The system is not suitable for use in the presence of a flammable, anesthetic mixture with air, oxygen, or nitrous oxide.

Warning: A risk of fire and/or explosion exists when the laser output is used in the presence of flammable materials, solutions or gases, or in an oxygen enriched environment.

Warning: Visible and invisible laser radiation is emitted from this device. Avoid eye or skin exposure to direct or scattered radiation.

Warning: Improper use of system controls or performance of procedures other than those specified in this manual may result in hazardous radiation exposure.

Warning: Failure to comply with all safety instructions and warnings may expose all participants to harmful levels of laser radiation.

Warning: Do not direct the laser beam at anything other than the area to be treated.

Warning: Do not look directly into the distal end of the optical fiber connected to an active laser device — with or without wearing appropriate laser-emission protective eyewear.

Warning: Do not allow any reflective object to fall into or obstruct the path of the laser energy produced by this device. Scattered or reflected laser energy can cause serious damage to eyes and skin. The operator, all assistants, and the patient must remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to performing therapy with this device.

Warning: There are no user-serviceable components inside the laser device. Do not attempt to gain access to any internal device component. Doing so may cause serious and/or irreversible injury.

Warning: Do not remove protective eyewear until the operator returns the laser device to “standby” mode. To do this, the operator releases the footswitch or activates the correct button via software, touches the “ready” button on the display panel, and visually observes the laser device returning to STANDBY mode.

Warning: Do not insert footswitch while in “external modulation” mode.

Warning: Do not insert DB-9M connector into remote control port while using footswitch.

Warning: The laser plume may contain viable tissue particulates.

The following warnings are from the Visualase™ cooled laser applicator system manual:

Warning: Permanent injury to the eyes can occur if persons in the surgical area fail to wear laser safety eyewear specifically for the wavelength(s) being used.

Warning: Proper use of the VCLAS requires an adequate knowledge of laser-tissue interaction and the physiologic processes associated with it.

Warning: The user should be well acquainted with the laser being used with the VCLAS and its wavelength’s interaction with the target tissue.

Warning: Prior to treatment, adjacent anatomical structures within the target tissue must be evaluated for susceptibility to collateral optical or thermal damage.

Warning: Excessive heating can cause char and tip destruction within the tissue. Although remote, the possibility exists for a portion of the tip to remain in the tissue under these conditions.

Warning: Using the VCLAS-400-12-T3-11 for longer than two-minute exposures at greater than 9-watt laser power may result in melting or charring of the catheter. In the event of a catheter melt, saline coolant may leak.

Warning: Using the VCLAS-400-12-T10-11 or VCLAS-600-12-T15-11 for longer than two-minute exposures at 15-watt laser power may result in melting or charring of the catheter. In the event of a catheter melt, saline coolant may leak.

Warning: Using any VCLAS for repeated laser applications without pulling the fiber back inside the catheter may increase the risk of melting the catheter.

Warning: Failure to use cooling flow may result in overheating the VCLAS which can lead to melting of the LDF and CCS.

Warning: The catheter and fiber are MR Safe up to 3.0T, however the SMA connector on the proximal end of the LDF is MR Conditional. Damage to imaging equipment or injury to patients can occur if appropriate precautions are not taken.

Warning: If a broken fiber is used with an operating laser, laser radiation can emit from the damaged portion of the fiber instead of the diffusing tip. Using a broken fiber can cause burns or damage to people or material near the break in the fiber. If you suspect a break in the fiber, immediately deactivate the laser and discontinue use of the fiber.

Warning: Debris on the face of the SMA 905 inserted into the laser coupler can preferentially absorb the laser energy resulting in significant heating at the laser connection point. This can cause damage to both the LDF and the laser.

Warning: Severe bending or mechanical deformation of the tip will result in uneven power distribution and possible tip failure during therapy.

Warning: Core diameter and numerical aperture incompatibility with the laser will result in improper coupling and could lead to damage to the laser and decreased power output from the diffusing tip.

Warning: This device is provided sterile. Do not open sterile-barrier packages or containers until surgical use.

Warning: This device is provided sterile and is for single use only. Do not re-process, re-sterilize, or re-use this device. Attempts to re-process or re-sterilize the device may be ineffective and may compromise its structural integrity. Any re-use creates a risk of contamination that could result in patient injury, illness, or death.

Warning: To avoid potential exposure to blood-borne pathogens and chemicals, use appropriate personal protective equipment when handling or disposing of single-use devices.

Warning: If transmissible spongiform encephalopathies or Creutzfeldt-Jakob disease contamination is suspected, incinerate the potentially contaminated device according to national regulations.

Warning: Prior to use, examine the product packaging for damage, deterioration, and expired shelf life. If found, do not use the product. Contact Medtronic Navigation.

Warning: Abandon use of any device damaged during the procedure. Do not use a fiber that has been dropped.

Warning: Do not alter the product. Only use the product in accordance with its labeling.

PrecautionsThe following cautions are from the Visualase™ cooled laser applicator system manual:

Caution: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

Caution: Lasers should only be operated by qualified personnel in appropriate areas.

Caution: All fibers and catheters are ethylene oxide sterilized for single use in a sterile surgical environment.

Caution: Do not bend the fiber or the cooling catheter sharply. This can cause fiber breakage, kinking of the catheter, and/or energy loss. In the event that excessive bending of the fiber results in a breakage, the aiming beam may be visible at the bend in a dark room.

Caution: Do not cut the jacketing around the fiber or the wall of the cooling catheter. This creates a weak point that will lead to failure of the fiber or the catheter.

Caution: Laser safety eyewear, specifically for the wavelength(s) being used, must be worn by all personnel when operating the laser to prevent eye injury.

Caution: The dust cover installed on the SMA 905 of the LDF should remain installed until the fiber is coupled to the laser.

Caution: Ensure the face of the SMA 905 is free of debris prior to connection to the laser.

Caution: Care should be exercised when inserting the fiber into any device, specifically intravenous introducers, cooling jackets, or other insertion device to avoid mechanical deformation.

Caution: The LDF should be used only with the provided Visualase™ system laser.

Caution: Comply with all safety precautions defined by the imaging modality that will be used.

Caution: Care should be taken when using the printed centimeter marks on the catheter to make accurate measurements. Misreading the measurement could result in improper depth placement of the applicator.

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