Greenlight XPS - Device Description; Console Overview; FiberLife Component; Vaporization Functionality

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
3
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
WARNING: Users of the GreenLight XPS™ Laser System should read this manual thoroughly before attempting surgical procedure. Pay attention
to all warnings, contraindications, precautions, and adverse events in this manual and other related material. Failure to thoroughly understand
and follow all instructions may result in harm to the patient or the user of the laser system.
1 DEVICE DESCRIPTION
The GreenLight XPS Laser System is designed for the vaporization and coagulation of soft tissue using light. One example procedure is the
endoscopic (transurethral) resection of the prostate for the treatment of Benign Prostatic Hyperplasia (BPH). The laser system consists of a
console, which generates the green laser light and a fiber optic delivery device that transmits laser light from the console to the patient. This laser
system is not intended to treat prostate cancer.
1.1 Console
The console is a diode-pumped solid-state laser utilizing Nd:YAG laser gain medium and Acousto-Optic Q Switch. The primary wavelength is 1064 nm.
Frequency-doubling crystal is used to generate a 532 nm output beam. Quasi-CW pulse repetition rate is 23.6 kHz. Pulse duration is approximately
100 ns. Pulse energy is approximately 8 mJ at maximum power (180 W). The console generates visible green 532 nm laser light. In vaporization
mode, the power settings range from 20 W to a maximum power determined by the fiber delivery device. In coagulation mode, the power settings
range from 5 W to 40 W. The console features a plug and play capability that self-adjusts to the facility’s supply voltage, eliminating the need for
electrical modifications of the operating facility. The console includes internal cooling mechanisms ensuring safe operating temperatures with no
external water connection. Laser energy emission and console status changes are activated through a surgeon-controlled, color-coded footswitch
or console touchscreen feature.
1.2 FiberLife
The console is equipped with the FiberLife feature. The FiberLife feature continuously monitors the temperature of the tip of the fiber and momentarily
stops the laser emission when the fiber gets too hot. In most cases, this will prevent damage to the fiber if tissue or vapor bubbles accumulate on the
tip or there is excessive heating of the fiber.
In most cases, the laser will turn back on immediately and the procedure continues without interruption. There will be noticeable blinking of the
working beam. If the FiberLife feature is activated continuously, vaporization efficiency will be significantly reduced. In this case, the fiber should
be cleaned or replaced. The console will automatically detect this condition, put the laser in Standby mode, and display a message.
The FiberLife feature will stop laser emission if the laser is accidentally fired while inside the cystoscope. Generally, this will prevent serious
damage to the cystoscope. Some discoloration of the metal may still occur, which can increase the possibility of corrosion.
1.3 Vaporization
The console uses photo-selective vaporization for the resection of soft tissue. The 532 nm green laser light emitted is strongly absorbed by
oxyhemoglobin in red blood cells. Absorption of the laser light energy results in the generation of heat, which bursts cells, effectively vaporizing the
targeted tissue. Additionally, the heat can coagulate blood vessels near the resected tissue, allowing for a clear surgical field. If bleeding occurs,
the console also has a pulsed coagulation feature.
1.4 Coagulation
The console has a pulsed coagulation feature. In this mode, activated when the coagulation (coag) footswitch is pressed, laser emission is pulsed
at a rate of ~12.5 Hz with a duty cycle of ~25 %. This pulse mode improves the coagulative effect.
1.5 User Information
Only persons trained in the use of the laser console and who have sufficient medical knowledge should use the GreenLight XPS Laser System. The
user should have a demonstrated understanding of the laser console’s operation and the risk associated with improper use.
1.6 Contents
• LaserConsole
• Footswitch
• FiberPole
• KeyChain
• LaserIn-UseSign
• PhysicianProtectiveEyewear
• SpectatorProtectiveEyewear
2 INTENDED USE/INDICATIONS FOR USE
The GreenLight XPS Laser System is intended for the surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.
All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous
membrane, lymph vessels and nodes, organs, and glands.
Suggested applications include:
• General Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue as well as in endoscopic (for example,
laparoscopic) or open surgeries.