INDICATIONS AND USE OF THE BSD-400/500 HYPERTHERMIA SYSTEM
CONTRADICTIONS
ADVERSE REACTIONS
DEVICE DESCRIPTION
Because the patient's ability to detect pain is an essential
SIDE EFFECTS Although hyperthermia has the potential
The BSD-400/500 Hyperthermia System delivers
safety mechanism, hyperthermia is contraindicated in
for producing a variety of adverse effects, those actually
therapeutic heat (hyperthermia) to certain surface or
patients whose pain response has been significantly
observed have been limited to direct effects of heating
subsurface malignant tumors (i.e., melanoma, squamous-
decreased by any means (previous surgery or ionizing
upon tissue and indirect effects related to tumor necrosis.
or basal-cell carcinoma, adencarcinoma, or sarcoma)
radiation therapy, regional or general anesthetic, or other
Statistical analysis of clinical data obtained in BSD
by the external or interstitial application of electro-
condition).
Medical's studies has provided the following approximate
magnetic energy, and monitors the temperature of
figures for hyperthermia in general:
target and surrounding tissues by means of invasive
Since excessive heating of normal tissue is prevented by
temperature probes. In response to an operator-
normal blood perfusion, it is imperative that adequate
Burns. Patients have experienced in 9.7% of tumor sites
designated control probe, the BSD-400/500 Hyper-
circulation be present and maintained in all tissues within
studied, surface burns and blistering in the area of the
thermia System automatically adjusts power to maintain
the heating field. Treatment with the BSD-400/500
delivery of therapeutic heat by local microwave
the operator-set therapeutic temperature, which
Hyperthermia System is contraindicated in patients
applicators of the BSD-400/500 Hyperthermia System.
typically is 42-44°C. The BSD-400/500 Hyperthermia
having known decrease in circulation in the heated area
Adherence to recommended applicator placement
System also automatically limits power to prevent any
produced by any means (i.e., vasoconstrictive drugs,
techniques and blousing practices greatly reduces the
detected temperature from exceeding the operator-set
DIC, ischemia or other cause).
number of incidents.
maximum, which cannot be greater than 59.9°C.
Because electromagnetic radiation from the applicators
Pain. Patients have experienced, in 8.4% of tumor sites
Tissue absorption of electromagnetic energy causes
of the BSD-400/500 Hyperthermia System may interfere
studied, localized and temporary pain in the area of, and
heating by molecular excitation. Living tissue dissipates
with the operation of an electronic device, hyperthermia
during delivery of, therapeutic heat by local microwave
accumulated thermal energy principally through transport
treatments are contraindicated in patients with cardiac
applicators of the BSD-400/500 Hyperthermia System. The
by blood perfusing the tissue. Solid malignant tumors of
pacemakers.
use of surface cooling techniques can diminish this pain.
significant size have less blood perfusion than
surrounding normal tissue. For a given absorbed thermal
RESTRICTIONS
Ulceration. Patients have experienced, in 3.6% of tumor
dose, the reduced ability to dissipate heat causes tumor
sites studied, ulceration from rapid tumor necrosis
tissue to reach higher temperatures than normal tissue.
The sale, distribution, and use of the BSD-400/500
following successful hyperthermia treatment with the
Therefore, absorbed electromagnetic radiation will
Hyperthermia System are restricted to prescription use.
BSD-400/500 Hyperthermia System. Such ulceration may
preferentially heat tumors present in normal tissue and
produce both fever through toxemia and patient discomfort
cause them to reach higher temperatures than the normal
The BSD-400/500 Hyperthermia System is to be used
through drainage and bleeding.
surrounding tissue. Tumors heated repeatedly to higher
only by qualified operators upon the prescription and
temperatures (hyperthermia) for times approaching an
under the supervision of a physician who is experienced
Infection. Patients have experienced, in 1.8% of tumor
hour sometimes exhibit regression and necrosis [Song,
in clinical hyperthermia.
sites studied, local and systematic infections resulting from
C.W., "Physiological Factors in Hyperthermia of Tumors"
the placement of the temperature probes of the BSD-
in Physical Aspects of Hyperthermia, G.H. Nussbaum, ed.
400/500 Hyperthermia System and from the ulceration
American Institute of Physics (American Association of
WARNINGS
related to rapid tumor necrosis. These infections have
Physicists in Medicine, Medical Physics Monograph No.
generally been local.
8). New York, NY: 1982, p.43].
Hyperthermia treatment can be safely and effectively
administered only after careful placement of temperature
POTENTIAL ADVERSE HEALTH EFFECTS
The BSD-400/500 Hyperthermia System consists of the
probes as described in the Reference Manual and with
following components:
alert monitoring of tissue temperatures during treatment.
OF THE DEVICE
(1) A set of microwave applicators for local therapy, as
Hyperthermia treatment presents a potential safety
Hyperthermia has the potential for producing the
listed in the following table, where "MHz" signifies
hazard in patients whose pain response has been
conditions listed below, as a result of the delivery of
Megahertz and "W" signifies Watts:
decreased because of disease, previous surgery, ionizing
therapeutic heat or of exposure to electromagnetic
radiation therapy, chemotherapy, or general or regional
radiation. However, none of these adverse reactions was
Applicator Model Recommended Typical
anesthesia.
observed during the clinical investigation of local
Type Number Freq (MHz) Power(W)
hyperthermia.
Side-loaded waveguide MA-100 915 100
The electromagnetic energy from microwave applicators
Mini dual-ridge waveguide MA-151 915 40
may interfere with the operation of the cardiac
Cataracts. Inadvertent heating of the eye may occur
Flexible interstitial coaxial MA-251 915 20
pacemakers or other implanted electronic devices.
during treatment of tumors in the head or neck. A single
Side-loaded waveguide MA-120 915 250
high dose of microwave radiation or repeated exposure
Large thermal doses (a continued elevation of
over a long period of time may result in cataract
moderately high temperature or a short extreme elevation
formation which may not be observable for several weeks.
(2) A set of non-perturbing, electro magnetically
of temperature) in normal tissues situated in the vicinity
[Clearly, S. F., "Microwave Cataractogenesis" in Proceed-
insensitive temperature probes.
of the treated tumor or between the tumor and the body
ings of the IEEE 68: 4955.]
surface may result in regions of thermal aseptic necrosis
(3) An operator console containing computer controls to
that require medical intervention and that may not be
Male Sterility. A single high dose of microwave radiation
obtain and display data from the temperature probes
apparent on inspection of the skin.
to the testes, or testicular heating for a prolonged period
and to condition the power output of the applicators,
of time, may result in temporary or permanent sterility.
and means to display and record relevant patient
Treatment of tumors located in the neck and head may
[Murca, G.J., E.S. Ferris. and F.L. Buchta. " A Study of
treatment parameters.
cause inadvertent heating of thermoregulatory centers
Microwave Radiation of the Rat Testis" in Biological
located in the brain stem and induce general
Effects of Electromagnetic Waves, C.C. Johnson and M. L.
(4) Various accessories, including blind-end catheters for
thermoregulatory response exceeding the patient's
Shore, eds. HEW publ. (FDA 77-8010). Washington, D.C.
the insertion of probes a probe calibration bath, a
compensatory capabilities.
1976, pp. 484-494.]
coupling and cooling water bolus system, a radiation
leakage monitor, and various patient equipment and
PRECAUTIONS
Exacerbation of pre-existing disease. Patients having
support such as an optional patient couch.
borderline cardiopulmonary function secondary to
Adhere to recommended procedures for temperature
coronary atherosclerosis, emphysema, or other conditions,
may not be able to tolerate the additional systematic stress
INDICATIONS FOR USE
probe placement and selection of control probe to
minimize the probability of excessive temperature in
of extensive or prolonged hyperthermia.
normal tissue or of inadequate temperature in the tumor.
The BSD-400/500 Hyperthermia System is indicated for
Enhanced drug activity. Elevated temperatures may be
use alone or in conjunction with radiation therapy in the
Observe strict adherence to aseptic techniques during
expected to affect the pharmacologic activity of some
palliative management of certain solid surface and
the invasive placement of catheters to avoid localized
drugs, with unpredictable results. Altered vascular
subsurface malignant tumors (i.e., melanoma, squamous-
infections, and instruct patients in the daily care of
perfusion may dramatically affect the local tissue effects of
or basal-cell carcinoma, adencarcinoma, or sarcoma)
indwelling catheters and probe sites to prevent sepsis.
systemic or infused drugs.
that are progressive or recurrent despite conventional
therapy.
To ensure accurate temperature monitoring during
Thermal Stress. Significantly increasing the core
treatments, verify calibration of temperature probes daily
temperature of the body or overheating the thermo-
PROCEDURE FOR ADMINISTRATION
or as used.
regulatory center in the brain my result in thermal stress
OF HYPERTHERMIA IN CONJUNCTION
exceeding the patient's compensatory mechanisms.
Reliable prediction of the consequences of thermal stress
WITH IONIZING RADIATION THERAPY
Adhere to recommended applicator placement and
blousing practices to reduce the likelihood of surface
in patients with cardiovascular impairment is not possible.
burns and blistering from the subsequent delivery of
Signs of consequences of thermal shock or of local brain
The standard therapy regimen for hyperthermia in
therapeutic heat.
overheating may appear after several (up to 24) hours.
conjunction with ionizing radiation therapy is a total of 10
Hyperthermia treatments delivered two times per week at
In patients with severely compromised pain response,
REFERENCES
72-hour intervals, with each heat treatment preceded or
monitor closely other physiological indicators of
1. Song, C. W., "Physiological Factors in Hyperthermia of
followed by a standard prescribed does of ionizing
excessive heat delivery.
Tumors" in Physical Aspects of Hyperthermia, G. H.
radiation within 30 minutes of the heat treatment. During
Nussbaum, ed. American Institute of Physics
each heat treatment, an intratumoral temperature of
(American Association of Physicists in Medicine.
Monitor closely patients with metallic implants (joint
42.5°C sustained for 60 minutes, or the equivalent
Medical Physics Monograph No. 8), New York, NY:
prostheses, dental braces, etc.) during treatment
thereof, entire course of treatment is 600, expressed in
2 Clearly, S. F., "Microwave Cataractogenesis" in
because such metal objects may be excessively (and
Thermal Equivalent Minutes (TEM) equal to 42.5
Proceedings of the IEEE 68: 4955.
°C, as
preferentially) heated.
3. Murca, G.J. E.S. Ferris, and F.L Buchta, "A Study of
calculated during treatment by the BSD-400/500
Microwave Radiation of the Rat Testis" in Biological
Hyperthermia System.
Effects of Electromagnetic Waves, C.C. Johnson and
M.L. Shore, eds. HEW publ. (FDA 77-8010). Washington.
DC, 1976, pp. 484-494.

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