to check that the laser emits laser radiation in those cases where there is no power meter available and the operator needs
to ensure that the device is functioning.
WARNING: Do not look at direct or non-diffuse reflections and avoid intra-beam viewing. The operator/patient may choose to use
correct protective eyewear to minimize unintentional exposure.
“CAUTION: Use of controls or adjustments or performances of procedures other than those specified herein may result in hazardous
situations.” The intent of the warning is to inform the operator that BASIC SAFETY may be compromised by not using the device in its
normal condition and in accordance with normal practice and intended use.
“WARNING: No modifications of this equipment are allowed.” This warning statement addresses the issue that HAZARDS can result
from an unauthorized modification of the ME EQUIPMENT, e.g. BASIC SAFETY may be compromised by a modification or an
alteration of the normal condition of the device.
8.4 Protective eyewear. Personal protective equipment (optional requirement)
If the responsible organization/operator or home patient wants to use protective eye safety wear the recommendations for protective
eye wear are as follows:
- Optical density should be minimum +3 (OD+3), which means that 1/1000 of the light passes through the protective eyewear.
- The power of a 0.05 W laser is reduced to 0.05 mW by using protective eyewear with OD+3
- The eye safety wear shall protect the wavelength the laser emits
Example of protective eyewear for a 904 nm 0.03 W laser. Wavelength range = 880 - 920 nm
NOTE: Many countries have regulations and standards for personal protective wear/equipment. Contact the appropriate national
agency for those requirements.
9 General electrical and mechanical safety
9.1 Cleaning/disinfection procedures
The device is not intended to be sterilized. The equipment is intended for direct physical contact with the patient on clean and dry skin
(normal skin conditions). Cleaning/disinfection should be performed before use. The operator is advised to clean the equipment with
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