M00001 REV3
9
WARNINGS
Purpose of use:
Device used for lightening the treatment area during podiatry
interventions
.
Its light emission features allow accurate identification of small details, without raising the temperature of the lit area.
The SUN LED lamp may be installed on a specific control and supply device, such as chiropractic units, or with an electrical
system that complies with IEC 364-1 norms and the national installation regulations for electrical systems in premises
adapted for medical use (check that the supply voltage, shown on the information plate, corresponds to that of the mains
supply). Use the lamp in suitable premises only, equipped and constructed in compliance with the regulations in force
regarding safety (IEC 60364-7-710).
Do not remove the labels attached to the device. Should these deteriorate, ensure that they are replaced.
Compliance with dire
ctive 93/42/CEE "Medical devices Directive”, with the directive 2006/95/CEE “Low Tension Directive”
and to the directive 2004/108/CEE “Electromagnetic Compatibility Directive” and subsequent amendments.
Do not carry out any maintenance operations on the lamp whilst it is connected to the power supply. Disconnect the power
supply cable from the socket before opening the device.
The insufficient performance of the lamp does not in any way compromise the safety of the patient.
Do not attempt any maintenance operations or replacement of any parts different from those shown in the handbook.
Do not direct the light beam directly or indirectly into anyone’s eyes, the high intensity of the light could damage the eyesight.
Climate:
Under extreme conditions (heat, cold, humidity) it is advisable to let a few hours pass between unpacking the equipment and
using it for the first time. This precaution provides the time needed to eliminate any condensation that may have formed
inside the packaging.
S.M.D. cannot be held liable for any damages deriving from failure to observe the warnings and instructions
contained in this handbook.
WARNING: any modification is not allowed
WARNING: not modify the device without the manufacturer's permission
WARNING: in case of modification of the device, you must perform examinations and tests in order to ensure its
continued safe use
Upon request SMD Srl will provide circuit diagrams, the parts list, descriptions, calibration instructions or other information to
assist the After Sales Service in repairing parts of the device indicated by SMD Srl as serviceable by the After Sales Service.
In relation to photobiological safety, SUN LED is classified with risk absent.
WARNING: The device cannot be used in environments with explosive atmospheres or fire risk.
Warnings for photo biological risk
According with the EN 62471, the device is classified as risk level 1 for the Blue radiation. In particular, the device has the
following emission data at a distance of 200mm. The device is classified risk free to UV, IR and retina.
Danger
Emission
Classification
Actinic UV
0.000000W∙m2
Exempt
Near UV
0.0000W∙m2
Exempt
Blue Light
4921,0 W∙m-2∙sr-1
Group 1
Blue
Light
small
source
43,73 W∙m-2
Group 1
Retinal Thermal
4764 W∙m-2∙sr-1
Exempt
IR Radiation
3,694 W∙m-2∙sr-1
Exempt
Photo biological risk: warnings for a correct use
The lamp must not be directly watched.
During the maintenance, disconnect the lamp from the power supply.
If you are to perform tasks with eyes looking directly at the source, you must use the appropriate PPE such as goggles with
filter systems and radiation shielding for the Blue radiation.
It is forbidden to change the brightness levels and alter the LED source.
The lamp must be handled with switch in the off position and turned on only upon placement. Moves the lamp is only
possible if patients are provided with the appropriate eye protection to safeguard their health.
