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.
Prescriptive Information
Refer to the operator's manual for complete instructions for use.
Indications
Urology indications:
The following applications are indicated for urology while using the Ho:YAG wavelength:
- Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate(HoLRP),hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH). The clinical procedure for HoLRP, along with clinical study results, is described in Appendix A of the operator manual.
- Open and endoscopic urological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
- Superficial and invasive bladder, urethral and ureteral tumors
- Condylomata
- Lesions of external genitalia
- Urethral and penile hemangiomas
- Urethral strictures
- Bladder neck obstructions
Contraindications
Urology contraindications
The Ho:YAG wavelength should not be used for HoLRP for treatment of BPH in patients with:
- Carcinoma of the prostate
- Desire for future fertility
The Ho:YAG wavelength should not be used in patients with the following conditions:
- Inability to receive endoscopic treatment
- Intolerance to anesthesia
Warnings
Refer to operators manual provided with product for a complete list of warnings.
General warning:
Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
Urology warnings:
Good clinical judgement should be used prior to performing the HoLRP procedure on patients who are taking anticoagulants.
Potential Adverse Effects
General laser complications
- Refer to complications specific to each surgical specialty and wavelength in the "Directions for Use"
- 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 could be serious and could result in death:
- Patients may experience bleeding at the site of laser therapy. Posttreatment 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.
Cautions
Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.
Urology precautions
The following precautions are suggested when using the Ho:YAG wavelength in urology:
- Care should be exercised so as not to over distend the bladder when using the laser endoscopically. Excessive bladder distention could result in coagulative necrosis of the superficial and inner muscular region of the bladder wall. The following precautions are recommended for HoLRP for treatment of BPH:
- Confirm that the tip of the fiber optic delivery device extends at least 1.25 centimeters beyond the end of the urethroscope or endoscope during laser treatment.
- Activating the laser when the tip of the delivery device is within the urethroscope or endoscope can result in penetration of holmium laser energy through the scope and destruction of the scope.
- Use caution during laser treatment near the verumontanum.
- The learning curve to obtain proficiency in HoLRP has been described by experienced urologists to be similar to that of learning TURP
Read “Directions for Use” for a list of additional precautions.
Trademark
Legal Manufacturer: Lumenis. Ltd. Distributed in the U.S. by: Boston Scientific Corporation.
VersaPulse, VersaPulse Select, PowerSuite and Duotome are trademarks of Lumenis Ltd. Copyright: 2007 Boston Scientific Corporation or its affiliates. All rights reserved
Prescriptive Information for VersaPulse® Powersuite 100w Holmium Laser
Indications
Urology indications:
The following applications are indicated for urology while using the Ho:YAG wavelength: - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate(HoLRP),hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH). The clinical procedure for HoLRP, along with clinical study results, is described in Appendix A of the operator manual.
- Open and endoscopic urological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including treatment of:
- Superficial and invasive bladder, urethral and ureteral tumors
- Condylomata
- Lesions of external genitalia
- Urethral and penile hemangiomas
- Urethral strictures
- Bladder neck obstructions
Contraindications
Urology contraindications
The Ho:YAG wavelength should not be used for HoLRP for treatment of BPH in patients with:
- Carcinoma of the prostate
- Desire for future fertility
The Ho:YAG wavelength should not be used in patients with the following conditions: - Inability to receive endoscopic treatment
- Intolerance to anesthesia
Warnings
Refer to operators manual provided with product for a complete list of warnings. General warning:
Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and the appropriate delivery system operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
Urology warnings:
Good clinical judgement should be used prior to performing the HoLRP procedure on patients who are taking anticoagulants.
Potential Adverse Effects
General laser complications
- Refer to complications specific to each surgical specialty and wavelength in the "Directions for Use"
- 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 could be serious and could result in death:
- Patients may experience bleeding at the site of laser therapy. Posttreatment 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.
Cautions
Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.
Urology precautions
The following precautions are suggested when using the Ho:YAG wavelength in urology:
- Care should be exercised so as not to over distend the bladder when using the laser endoscopically. Excessive bladder distention could result in coagulative necrosis of the superficial and inner muscular region of the bladder wall. The following precautions are recommended for HoLRP for treatment of BPH:
- Confirm that the tip of the fiber optic delivery device extends at least 1.25 centimeters beyond the end of the urethroscope or endoscope during laser treatment. Activating the laser when the tip of the delivery device is within the urethroscope or endoscope can result in penetration of holmium laser energy through the scope and destruction of the scope.
- Use caution during laser treatment near the verumontanum.
- The learning curve to obtain proficiency in HoLRP has been described by experienced urologists to be similar to that of learning TURP.
Read Directions for Use for a list of additional precautions.
Trademark Legal Manufacturer: Lumenis. Ltd. Distributed in the U.S. by: Boston Scientific Corporation.
VersaPulse, VersaPulse Select, PowerSuite and Duotome are trademarks of Lumenis Ltd. Copyright: 2007 Boston Scientific Corporation or its affiliates. All rights reserved.
