Proprietary and Confidential. Printed copies will not be updated.
MNL-00049 [1]
Page
7
of
19
•
All treatments must be administered under the direction of a licensed physician only.
•
Device is not to be used in MR environments that may include MRI, diathermy, electrocautery,
or other high frequency equipment.
•
Do not treat if the lamps fail to ignite. Consult with doctor and/or contact Daavlin customer
service. (See page 21)
•
If lamps turn on without treatment being started/resumed, or if lamps do not turn off when
treatment is completed, unplug the device. Contact doctor and/or Daavlin customer service.
(See page 21)
•
DT
Controlled
Phototherapy Devices are considered CISPR Group 1, Class A devices, to be
used
for prescription use only
.
8.0
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
WARNING:
Equipment not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.
9.0
Labels and Symbols
If the unit is equipped with FlexRx
™ exposure limiting software, there will be a label similar to the
one shown below
below informing you that your unit has been equipped
with this feature.
Figure 1 FlexRx Label
