Prescriptive Information for DuoTome SideLite™ Fiber
Indications The DuoTome SideLite™ Fiber delivery device is compatible with the following lasers:
- VersaPulse® 2.1 Holmium
- VersaPulse Select™ Holmium
- VersaPulse Select Dual Wavelength
- VersaPulse PowerSuite™ Holmium
- VersaPulse PowerSuite Dual Wavelength
The device is intended for use with the compatible lasers in surgical procedures involving open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue, cartilage, and calculi. For the safe use of the devices, read and comprehend these instructions and the appropriate laser operator manual before use.
Contraindications
The device is contraindicated for treatment of patients for whom endoscopic procedures are contraindicated. Refer to the laser operator manual for contraindications that may be specific to each surgical specialty.
Precautions
To avoid damage to the fiber:
- Ensure that the scope port is open prior to inserting the
fiber into the scope.
- Avoid bending the fiber, particularly when holding the
handpiece or manipulating the scope.
- Avoid clamping or clipping any devices such as a hemostat on to the fiber.
- The DuoTome SideLite fiber is designed for use in an
aqueous environment only. Do not use the device in air,
and do not insert the tip into tissue. Both conditions do
not provide an adequate aqueous environment for proper
cooling of the tip and will permanently damage the device.
To avoid damage to accessory devices:
- Avoid direct laser beam contact with accessories. Baskets, guide wires, and other ureteroscopic accessories may be damaged.
Potential Complications
General complications associated with holmium and Nd:YAG wavelengths
- The potential complications encountered in endoscopic laser surgery are the same as those normally encountered in conventional endoscopic surgery.
- Acute pain may occur immediately following laser therapy and may persist for as long as 48 hours.
- Immediately following laser therapy, the patient may experience fever and leukocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment.
- Laser-ablated tissue may become necrotic or infected after treatment. If a question of infection exists, appropriate treatment should be carried out.
The following complications are serious and could result in death:
- Patients may experience bleeding at the site of laser therapy. Post-treatment hematocrits are recommended to identify this potential complication.
- Sepsis can result from performing any surgical procedure. If a question of sepsis exists, appropriate evaluations should be made.
- Perforation may occur as a result of laser treatment. To diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.
Fiber Degradation Indicators
- Aiming beam fades or disperses
- Ablation rate diminishes
- Metal cap distorts, discolors or indents
These changes do not require discontinuing of use, but do
indicate that the fiber is becoming less efficient.
In the final phase of degradation, white flashes of light may
appear at the tip, the aiming beam may exit at a point other
than the energy exit window or a sudden increase in bubbles at the metal cap may occur. Discontinue use and replace with a new fiber to complete the procedure, if necessary. The use of more than one fiber in some cases may be necessary, particularly when treating larger glands.
U.S. federal law restricts this device to sale by or on the order of a physician.
Trademark
VersaPulse, VersaPulse Select, PowerSuite and Duotome are trademarks of Lumenis Ltd.
Legal Manufacturer: Lumenis. Ltd. Distributed in the U.S. by: Boston Scientific Corporation.
Copyright: 2007 Boston Scientific Corporation or its affiliates. All rights reserved.
