Visualase
MRI-Guided
Laser Ablation

Indications, Safety, and Warnings

Visualase Thermal Therapy System

For full details, please refer to your System Manual.

Indications for Use

The Visualase^® Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1060nm.

When therapy is performed under MRI guidance, and 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 complex 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 Thermal Therapy System is compatible with General Electric Medical Systems Signa Model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. 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.

Contraindications

The following contraindication is from the Visualase Cooled Laser Applicator System manual:

The Visualase Cooled Laser Applicator System should not be used if thermal therapy or interstitial laser therapy are contraindicated.

The following contraindications are from the PhoTex Laser User Manual:

We strongly recommend physicians weigh advantages and disadvantages of using a diode laser. Other modalities or wavelengths may be more appropriate due to any of the following:

• Depth of penetration
• Volume of necrosis
• Propensity of scarring

This product should not be used if thermal therapy or interstitial laser therapy are contraindicated.

Use only in specialties listed in the Indications for Use.

For those whom the physician determines the laser is not the surgical tool of choice.

Patients who are unable to be treated by surgical means or who are intolerant to anesthesia.

Do not use endoscopically in any procedure where endoscopes are contraindicated.

Warnings

Do not perform any assembly of the Visualase™ Thermal Therapy System. All assembly is to be done by Medtronic Navigation, Inc.

The Visualase™ System should not be used with an extension cord.

Do not connect items to the Visualase™ System which are not specified as part of the system.

Use the Visualase™ System only in an appropriate, dry area with proper power and grounding connections.

Read all cautions and procedures in the accompanying “PhoTex15 User Manual” before operating the laser.

Read all cautions and procedures in the accompanying “Visualase™ Cooled Laser Applicator System INSTRUCTIONS FOR USE” before using any Visualase™ laser applicator.

Read all cautions and procedures in the accompanying “Visualase™ Software User Manual” before using the Visualase™ Thermal Therapy System.

The multi-socket outlet strip provided with the Visualase™ system is only to be used for components supplied with the Visualase™ system. Do not connect other electrical devices to the multi-socket strip.

Do not connect any equipment which has not been supplied as part of the System to the multi-socket outlets supplied with the system.

Do not take any component other than the Visualase™ Cooled Laser Applicator into the high-field region of the MRI magnet.

Do not attempt to lift or tilt the Visualase™ Thermal Therapy System. Damage to the system or harm to the operator may occur.

Always inform hospital staff of any changes made to the hospital capital equipment, including the IT infrastructure.

The following Warnings are from the Visualase Cooled Laser Applicator System manual:

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

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

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

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.

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.

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.

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

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

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.

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.

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.

Severe bending or mechanical deformation of the tip will result in uneven power distribution and 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.

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

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.

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

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

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

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

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

The following Warnings are from the PhoTex Laser User Manual:

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

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

Never direct the laser beam at anything other than the area to be treated.

Never allow the eyes of any living being to 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.

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 treatment with this device.

There are no user-serviceable components inside this laser device. Therefore, do not attempt to gain access to any internal device component. Doing so may cause serious and/or irreversible injury.

Do not remove protective eyewear until the operator returns the laser device to Standby mode. To do this, the operator releases the foot switch, touches the Ready screen button on the display panel, and visually observes the laser device returning to Standby.

Do not insert foot switch while in External Modulation Mode.

Do not insert DB-9M connector into Remote Control Port while using foot switch.

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 Laser plume may contain viable tissue particulates.

Precautions

The following Cautions are from the Visualase Cooled Laser Applicator System manual:

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

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

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

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.

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.

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

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

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

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

The LDF should be used only with the provided VTTS laser.

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

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.

The following Cautions are from the PhoTex Laser User Manual:

Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual.

This laser device produces infrared laser energy that is invisible and can be an extreme hazard to the eyes of any living being. Irreparable corneal and/or retinal damage many occur if a person exposes one or both eyes to direct or indirect (reflected) laser energy.

The protective eyewear used should have an optical density rating greater than 5 for the appropriate wavelength range and meet ANSI Z136.1 and Z136.3. All personnel present during device operation must wear this eyewear.

Select a secure, properly equipped, and well-ventilated location in which to install and operate the laser.

Place “Laser in use” signs at location entrances where people will use the laser device.

Always put the laser in Standby mode or switch the device off prior to adjusting or preparing the delivery system.

Never leave the laser in Ready mode.

Remove the key from the device’s key switch when not in use to prevent unauthorized and/or unqualified use of the device as well as inadvertent laser emissions.

Turn the device off before relocating equipment in the same vicinity.

Never press the foot switch without first verifying the safe orientation and proper positioning of the delivery system and ensuring compliance to all safety precautions.

During any laser procedure, do not allow any nonessential personnel into the treatment area.

Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual.

Always clean the SMA connector of the delivery system before inserting into the SMA emission port. Debris on the connector could result in damage to both the delivery system and laser unit.

Always screw the provided protective cap onto the laser’s SMA connector when the laser is not in use.