27
Intelect® Neo Clinical Therapy System
DESCRIPTION OF DEVICE MARKINGS
The markings on the unit are assurance of its conformity to the highest
applicable standards of medical equipment safety and electromagnetic
compatibility. One or more of the following markings may appear on the
device:
Refer to Instructional Manual Booklet . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Equipment capable of delivering output values in
excess of 10 mA r.m.s. or 10V r.m.s. averaged over any period of 5s. . . .
Testing Agency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Dangerous Voltage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Type B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Electrical Type BF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intensity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Lock/Unlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ON/OFF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Laser Stop Switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
This unit is considered to be a Class 3B laser product and thus emits visible
and invisible laser radiation (IR). Avoid direct eye exposure to the Laser beam.
The symbol to the right is located on the back of the applicator and indicates
the active radiant surface (the area on the applicator that emits infrared laser
energy and the direction of the beam of light) . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ULTRASOUND SPECIFICATIONS
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 MHz, ± 5%; 3.3 Mhz, ±5%
Duty Cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10%, 20%, 50%, Continuous
Pulse Repetition Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16, 48, or 100 Hz
Pulse Duration . . . . . . . . . . . . . . . . . .1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%
Output Power
Large Crystal . . . . . . . . . . . . . . . . . . . . . . . 0-15 W at 1 MHz, 0-10 W at 3.3 MHz
Medium Crystal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-6W @ 1 and 3.3 MHz
Small Crystal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0-3 W @ 1 and 3.3 MHz
Amplitude. . . . . . . . . . . . . . . . . . . . . . . . . . .0 to 2.5 W/cm
2
in continuous mode,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0-3 W/cm
2
in pulsed modes
Output accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ± 20%, 10% of maximum
Temporal Peak to Average Ratio: . . . . . . . . . . . . .2:1, ± 20%, at 50% Duty Cycle
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5:1, ± 20%, at 20% Duty Cycle
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9:1, ± 20%, at 10% Duty Cycle
Beam Nonuniformity Ratio. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6:1 maximum
Beam Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Collimating
IPXX Rating for Unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX0
IPXX Rating for Applicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IPX7
E
ff
ective Radiating Areas (Intelect Neo)
Description
ERA cm
2
(minimum)
Large Crystal
5.0
Medium Crystal
2.0
Small Crystal
1.0
Treatment Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 to 30 min
Head Warming Feature
The Head Warming feature of a Intelect® Neo Clinical Therapy System utilizes
Ultrasound output, resulting in warming of the Applicator to increase patient
comfort.
With Head Warming enabled, ultrasound is emitted without pressing the
Start button while an ultrasound treatment is being setup. The Applicator LED
will not illuminate during the Head Warming period. US Channel will indicate
“Head Warming”.
Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0 - 50% Cycling of maximum power
Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3 MHz
Applicator Temperature. . . . . . . . . . . . . . . . . . . 29.4 °C - 43.3 °C (85 °F - 110 °F)
SPECIFICATIONS
LASER SPECIFICATIONS
Power
Output Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Infrared Lamp (Laser)
Laser Class. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3B
Laser Technical Speci
fi
cations
Pulse Frequencies. . . . . . . . . . . . . . . . . . . . . . . . 8 Hz - 10000 Hz and continuous
Wavelengths. . . . . . . . . . . . . . . . . . . . . . 670-950 nm (dependent on applicator)
Output. . . . . . . . . . . . . . . . . . . . . . . . . 100-1440 mW (dependent on applicator)
Output accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +/- 20% of nominal