PRODUCT NAME
Bioptron YouThron
APPLICATION
Professional device for the treatment with polarized light
PRODUCER
BIOPTRON AG - Sihleggstrasse 23, CH-8832 Wollerau - Switzerland
FILTER/GLASS DIAMETER
ap. 2 in
COLOR
White & Gray (dark)
VOLTAGE
Power supply 100-230 V~, 50/60 Hz
POWER CONSUMPTION
0.29 - 0.12 A
PROTECTION AGAINST OVERHEATING
YES
WORKING TEMPERATURE
when used: from+50°F to + 86°F; for storage: from 32°F to + 104°F
DEGREE OF POLARIZATION
>95% (590 - 1550 nm)
CERTIFICATIONS/DECLARATION
* Declaration of Conformity with the medical Directive 93/42 / EEC issued by the producer. *Confirmation of application a medical device in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products * CE conformity for electrical equipment. * Certificate for Quality Assurance (EN ISO 9001) * Certificate for Quality Assurance (EN ISO 13485) * Certificate for the Quality Assurance System (Directive 93/42 / EEC) issued by the FDA * DEKRA Certificate for quality control EN ISO 9001:2008 - EN ISO 13485:2012 + AC:2012 * DEKRA Certificate for medical devices complying with Annex II, Section 3 of Directive 93/42 / EEC - (Notified Body ID 0124) * Declaration of conformity from DEKRA (European notified body) for all products issued in 2013 (07.21.2013)