2. Technical Specifications of the EXOGEN 4000+™
Ultrasound Signal
Ultrasound frequency ............1.5 ± 5% megahertz (MHz)
Modulating signal burst width....200±10% microsecond (
μ
s)
Repetition rate ............................1.0 ± 10% kilohertz (kHz)
Effective radiating area...........3.88 ± 1% square cm (cm
2
)
Temporal average power..........117 ± 30% milliwatts (mW)
Temporal maximum power.....625 ± 30% milliwatts (mW)
Peak power ............................................1.25 ± 30% watts
Spatial avg.–temporal avg. (SATA) .......30±30% mW/cm
2
Spatial avg.–temporal maximum (SATM)..161±30% mW/cm
2
Beam non-uniformity ratio (BNR).................4.0 maximum
The device uses a non-electrical, plastic locating
component, the Retaining and Alignment Fixture (RAF).
When incorporated into a strap, the RAF is used for a
Non-Cast application or for an On-Cast application. The
RAF is also available for incorporation into a cast for In-
Cast applications. The RAF Cap Assembly is snapped
on the RAF after the insertion of the transducer during
treatment periods. In both On-Cast and Non-Cast
applications, the RAF/strap is applied to the cast or skin
over the fracture site and insures proper positioning
during the 20-minute treatment period. During non-
treatment periods in both the In-Cast and On-Cast
applications, the transducer is removed and replaced
with a felt plug to maintain even pressure on the skin.
The RAF Cap is replaced on the RAF during non-
treatment periods.
Neither you nor your physician can select or change any
of the EXOGEN 4000+ ultrasound signal specifications.
3. The EXOGEN 4000+ System Components
The EXOGEN 4000+ device is composed of a Main
Operating Unit (MOU) Assembly with a permanently
attached transducer, and accessory items, which are
shown below in (
Figure 1
)
.
a.
The Main Operating Unit (MOU):
The Main
Operating Unit (MOU) is powered by a non-
replaceable and non-rechargeable lithium battery
pack with a life of a minimum of 150 treatment
periods of 20 minutes each. Since the range of the
number of total treatment sessions for some patients
may exceed this number, your device may require a
battery change (see Section J). The MOU is
connected to the transducer by a permanently
attached coiled inter-connecting cable.
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