Daavlin 1 Series - Device Indications and Specifications; Indications for Use; Device Classifications; Operating Specifications

MNL-00007 [3] Proprietary and Confidential Page 6 of 63
2.0 Indications for Use
The UV Series, 7 Series, and M Series, are medical ultraviolet devices, which are intended for
the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I – VI).
The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet
radiation for diagnosed skin disorders. The 1 Series, equipped with PL-L36w/03 blue lamps, is
indicated for the treatment of mild to moderate acne vulgaris.
The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet
radiation for diagnosed skin disorders.
WARNING: Do not use these devices for anything other than their intended purposes.
CAUTION: Federal law restricts this device to be sold by or on the order of a physician or any
other practitioner licensed by the law of the state in which he/she practices.
3.0 Classifications
FDA:
Class II Device
93/42/EEC:
Class IIa Device
IEC 60601-1:
Class I Device
Pollution Degree:
Class II
Mode of Operation:
Non-continuous
IEC/EN
62471:2006 UV
Risk Group:
Risk Group 2 (Moderate-Risk)
WARNING: This device is designed for intermittent operation only and not for continuous use.
The device should not be cycled continuously for more than 10 minutes. After such time, the unit
should either be turned off or left idling for at least 10 minutes.
4.0 Operating Specifications
Ambient
Temperature:
15°C to 30°C (59°F to 86°F)
Relative Humidity:
10% to 95%, Non-condensing
Liquid Ingress
Rating:
IPX0 (This device does not have protection
against ingress of water.)
Ocular Hazard
Distance:
3 Meters (9.84 Feet)
Ambient
Luminance:
250 – 500 lux