Daavlin ML24000 - Indications for Use; Classifications; Operating Specifications

MNL-00024 [1] Proprietary and Confidential Page 5 of 21
2.0 Indications for Use
The Daavlin ultraviolet light emitting device contained in this manual are intended for use, by or under
the direction of a physician, for the therapeutic treatment for individuals who require ultraviolet or
visible 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 sale 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 treatments greater than 20 minutes in duration the device
should be either turned off or left idling for a minimum of 50% of the administered treatment time, e.g.
a treatment lasting 40 minutes in duration should be followed by a cool down period of 20 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)
Altitude:
≤ 2000m
WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.