Laser safety
WARNINGS:
- Due to possible danger from electromagnetic radiation, it is recommended that persons with pacemakers or who are pregnant should not be present within the range of the laser.
- 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. The respective protective measures are to be taken.
- Wear the prescribed laser protective goggles in the laser area during laser emission.
- No authorized modification of this equipment is allowed. Do not attempt to repair or alter any components/ parts of Auriga XL.
Safety instructions
* Use of mobile phones or similar devices, is not permitted during laser operation.
CAUTIONS:
- Like any medical device, a laser requires special expertise and care in handling and use. The laser must only be used by persons who are instructed in proper handling of the device under consideration of the operating instructions and who are familiar with its therapeutic effect and possible danger and adverse events.
- Use of the laser, operating device or setting options in any other manner than described here may lead to serious injury.
- Never use any damaged or unsterilized laser fibers.
Safety Notes:
- Only persons trained in the use of the laser, and who have sufficient knowledge, should service the Auriga™ XL Laser.
- With improper use, every laser can lead to serious injury. The Auriga XL is a Class 4 laser product according to EN 60825-1:2007.
- When installing the Auriga XL, ensure that the floor is even to prevent the system from tipping over.
- The system is intended to be used in a standard surgical room with standard lighting.
- It is recommended to use the Auriga XL only in rooms with:
a temperature of 18 °C - 28 °C (64 °F - 82 °F),
humidity of 30 % (≤ 75 % non-condensing), and
pressure range of 795 - 1060 hPa.
- Reflective materials or instruments may deflect the laser beam in an uncontrolled fashion. Take special care with glass surfaces, but high-gloss metal surfaces may also cause dangerous laser beam dispersion even at a distance of several meters.
- During operation, the laser area must be locked off and marked according to safety standard DIN EN / IEC 60825.
- Only use “single use” or “reusable” laser fibers approved by StarMedTec/Boston Scientific with the Auriga XL.
- The operator must ensure that protective measures against fire and explosion are taken in case of medical application of laser radiation in the area of organs, body cavities and tubes that may contain flammable gases or vapors.
- Hold the fiber tip to a non-reflective surface, and ensure that a circular green spot appears. If the spot is weak or not visible, do not use and return the fiber to StarMedTec/Boston Scientific for replacement.
- The safety distance (NOHD) of the working beam for the laser facility during use in the normal state (IEC 60825-1) is 0.6 m.
Eye Protection:
- Within the operational area, every person must wear laser protection goggles or suitable eye protection to prevent eye injury. Prior to use, always check that the laser protection goggles are in perfect condition (i.e. they must not have any mechanical damage). The type of goggles stipulated in the following must be used.
- The laser protection goggles for the Auriga XL must comply with at least the following conditions:
