VELASⅡ-30AB

Clinic indications

The intended use of the “VELASⅡ-30AB” is to cut, excise, vaporize, and coagulate tissues. The specific applications including: surgical procedures such as general surgery, endovenous laser therapy (EVLT), and ear/nose/throat (ENT) interventions. 
The physician should be aware of the clinical applications for the laser when the exact therapy of the diode laser in each clinical case cannot be known clearly.

Prohibited to be applied in:

The patients who have heart trouble, psychosis, hypertensive diseases or any patient who has been proved are not suitable for the therapy of laser. 

Contraindications:

  • Patients who have used isotretinoin (Accutane) within the past 6–12 months.
  • Patients taking medication known to increase sensitivity to sunlight.
  • Patients who have heart trouble.
  • Patients who have psychosis.
  • Patients who have hypertensive diseases.
  • Patients who have been proved are not suitable for the therapy of laser.
General Overview

The “VELASⅡ-30AB” consists of three main components

(1) Main device;
(2) Foot switch;
(3) Accessories: include remote interlock connector, fuse, key, power cord, safety goggles, fiber and etc.
The laser system consists of the fiber-coupled diode laser module, power supply, control panel, safety shutter and the embedded computer control system.

Specifications

Laser type

GaAlAs diode laser

Model

VELASⅡ-30AB

Wavelength

810nm±10nm;

980nm±10nm

Output power

810nm: 0.5-15W (±10%), adjust step:0.1W

980nm: 0.5-15W (±10%), adjust step:0.1W

810nm+980nm: 1W-30W (±10%), adjust step:0.1W

St of Output power

≤10%

Rp of Output power

≤10%

Operation mode

CW, Pulse

Beam divergence

Working beam: ≤25°

Aiming beam: ≤25°

Pulse width

10μs-10s

Pulse repetition rate

1Hz-50 KHz

Application systems

Fiber core diameter ≥400μm

NA ≥0.22

With SMA905 connector

Before use must sterile

Transmission system

contact: fibers of 400μm, 600μm and 800μm with SMA905 connector;

Non-contact: fibers and tips

Aiming beam

Diode laser of 650nm, power≤5mW, adjustable brightness.

Operation interface

Color LCD touch screen

Power supply

~100-240V, 50-60Hz, 350VA

Laser Class

4

Safety classification

ClassⅠType B

Cooling

Air

FUSE

F5AH250V

Dimensions

400(W)*385(L)*200(H)mm

Weight

12.9kg

Waterproof level

IPX1

Footswitch Waterproof level

IPX8

Operating Environment

Temperature is 5℃~40℃, relative humidity is no more than 80%, and atmospheric pressure is 860hPa~1060hPa.

Storage Environment

Temperature is -20℃~50℃, relative humidity is less than 80%, and atmospheric pressure is 500hPa~1060hPa.

Visible and Invisible Laser Radiation

Avoid Eye or Skin Exposure to

Direct or Scattered Radiation

CLASS 4 LASER PRODUCT

DIODE LASER 810nm and/or 980 nm+/-10nm Max.30W

DIODE LASER 650nm +/-10nm Max.3mw

EN/IEC 60825-1:2014

EN 60601-2-22:2020/IEC 60601-2-22:2019

WARNING: Always wear protective eyewear when using this unit.

The optical power output from this system can cause severe eye damage or other injuries. Always wear protective eyewear when using this unit. Exercise extreme caution to prevent injury.

This equipment is intended for use by trained physicians or scientists only, and should only be operated by qualified personnel who have familiarized themselves with the operating parameters of this product prior to use.

The “VELASⅡ-30AB” is a class 4 laser according to Directives EN/IEC 60825-1:2014.

A class 4 laser is hazardous to the eye from both direct beam and diffuse reflection of the beam. It also represents significant skin and fire hazards.

   Danger!

Do not use the unit near flammable anesthetics or other flammable substances.

Avoid eye or skin exposure to direct or scattered radiation. Take all necessary precautions in areas in which the laser is being used.

Near infrared light (810nm/980nm) from the “VELASⅡ-30AB” passes through the transparent components of the eye and is focused on the retina at the back of the eye. This can cause an acciphysical therapy retinal burn.

Only protective glasses designed for protection from cw-diode laser radiation at a wavelength of 810nm/980nm +/-10nm with an optical density of OD 4 should be used. Glasses not designed to this specification are not suitable for eye protection. Suitable glasses are available from your Gigaalaser representative.

Nominal Ocular Hazard Distance (NOHD) is 6m from the distal end of the fiber.

   Attention!

Do not stare into the aiming beam or view the aiming beam directly through optical instruments. Avoid direct exposure to the aiming beam.

Avoid placing reflective material, such as metal and glass, into the beam.

   Attention!

Acciphysical therapy irradiation to other than the target tissue may result in laser burn.

   Attention!

The “VELAS-30AB is only to be used in combination with a footswitch and specified application and light delivery systems appendant to the device.

   Attention!

Please avoid touching the patient and the foot switch / door contact /service connector socket simultaneously.

   NOTE:

A minimum distance of 25 cm should be maintained between the ventilation slots and the walls.

To prevent the risk of electrical shock, do not remove the cover. All servicing should be done by Gigaalaser or by qualified personnel authorized by Gigaalaser. After the end of guarantee period servicing can also be done by sufficiently qualified persons.

The equipment should be routinely inspected and maintained in accordance with the instructions given in the maintenance section of this manual.

Separate the unit from power supply before cleaning and disinfecting.

   Caution!

Use controls or adjustments or performing procedures other than those specified in this manual may result in hazardous radiation exposure.

   NOTE!

Laser equipment not in use should be protected against unqualified use by removing the key from the key switch.

Any malfunction or deterioration in the characteristics and/or performance of a device, or inadequacy in the labeling or instructions for use, please contacts us to confirm first.

Under reasonably foreseeable environmental conditions, when the product fails due to exposure to magnetic fields, external electrical influences, electrostatic discharge, pressure or pressure changes, acceleration, heat sources, etc., please contact us to confirm first.

 

See the manual for detailed information, you can contact us.

Company: Gigaalaser Company Ltd.

Add.: B15-8F Wuhan Hi-tech Medical device park, Gaoxin Road #818, East Lake New Technology Development Zone (Pilot Free Trade Zone Wuhan Area), Wuhan Hubei, 430206, China 

Tel: +86-27-65317650

Email: info@gigaamedical.com