AngioDynamics UK Limited AS0670 사용자 설명서
DELTA 15/30
DELTA 15/30 Operator Manual
Page 2.5
Version B.2
SAFETY CLASSIFICATIONS, HAZARDS AND PRECAUTIONS
This product is classified as a Class IV laser product in compliance with FDA 21
CFR 1040.10 and 1040.11, UL 60601-1, EN 60601-1, EN 60601-1-2, EN 60601-
2-22 and EN 60825-1.
CFR 1040.10 and 1040.11, UL 60601-1, EN 60601-1, EN 60601-1-2, EN 60601-
2-22 and EN 60825-1.
This product conforms to the requirements of Council Directive 93/42/EEC of the
Council of European Communities (Medical Devices Directive). Affixing the ‘CE
Mark’ to the instrument indicates conformity to this directive.
Council of European Communities (Medical Devices Directive). Affixing the ‘CE
Mark’ to the instrument indicates conformity to this directive.
0086
The local Laser Safety Officer should review all procedures for safety prior to system use.
A Class IV Laser is hazardous to the eye from the direct beam and diffuse reflections. It
also presents significant skin and fire hazard.
also presents significant skin and fire hazard.
Avoid eye or skin (except specific treatment) exposure to direct or scattered radiation.
Take all necessary protective measures, as explained in the rest of this section, in areas
where the laser is being used.
Take all necessary protective measures, as explained in the rest of this section, in areas
where the laser is being used.
All personnel must wear approved protective glasses appropriate to the wavelength of the
DIOMED DELTA 15/30
to reduce the risk of eye damage.
The aiming beam is a Class IIIa Laser and an unprotected eye may view the beam
scattered from a non-reflective surface. Do not stare into the aiming beam or view it
directly with optical instruments.
scattered from a non-reflective surface. Do not stare into the aiming beam or view it
directly with optical instruments.
Avoid directing the laser beam anywhere other than the treatment area or calibration
ports.
ports.
Before using a fiber, check it carefully for any signs of damage during storage or transit.
Protective caps should be in place over SMA connectors. All screws and ports should be
secure. Do not use if there is any sign of damage.
Protective caps should be in place over SMA connectors. All screws and ports should be
secure. Do not use if there is any sign of damage.