Alpha-Stim®
devices are sold by or on the order of a licensed healthcare/mental
health practitioner (U.S.), including physician, dentist, podiatrist,
nurse
practitioner, chiropractor,
naturopath, psychologist, MCSW, acupuncturist and physical therapist.
Please check with your state's licensing board when in doubt.
When ordering an Alpha-Stim® unit you must specify the
model to avoid unnecessary delays in dispensing the device
to your patient, i.e. "Alpha-Stim® 100”, “Alpha-Stim®
SCS” or “Alpha-Stim® PPM” and please
state
"no substitutions" (please see model comparison below).
Please include your degree and license number on the prescription
or on the Statement
of Medical Necessity.
No Rx is required for shipments outside the U.S. but consultations
with a qualified healthcare professional are strongly recommended,
especially for patients with difficult or unresponsive conditions
and for patients taking prescription medications.
Statement
of Medical Necessity for Alpha-Stim® purchase or rental
|
If
your clinic does not dispense Alpha-Stim® devices
directly
to patients at this time, we would be happy to serve
your
clients. You may send us a medical order directly
and
we will follow up with the patient. The Rx and patient
contact information can be faxed to us using our dedicated
fax line (888-684-8414), scanned and sent to us as an
email attachment, or mailed to:
Clinical Support
Allevia Health, Inc.
2312 NW Kings Blvd.
Corvallis, OR 97330 |
Model comparison
| |
Alpha-Stim®
100
For treating multiple pain areas, and anxiety, insomnia
and depression often associated with chronic pain. |
Alpha-Stim®
SCS
For treating anxiety, iinsomnia and depression without
pain. |
Alpha-Stim®
PPM
For treating simple pain problems on one or two
areas of the body without attendant anxiety, insomnia
and depression. |
| Primary
Indications |
|
|
|
| .....Pain |
• |
|
• |
| .....Anxiety |
• |
• |
|
| .....Insomnia |
• |
• |
|
| .....Depression |
• |
• |
|
| Treatment
Methods |
|
|
|
| .....Probes
for Pain |
• |
|
|
| .....Electrodes
for Pain |
• |
|
• |
| .....Ear
clips for CES |
• |
• |
|
| Five
(5) Year Warranty |
• |
• |
• |
| Clinical
and Technical Support |
• |
• |
• |
CE conformity
statement for Europe
The Alpha-Stim®
100 and Alpha-Stim® SCS are class IIa, Type B medical devices.
They have been independently tested by outside agencies in order
to provide assurance of conformity to applicable standards for
medical equipment safety and electromagnetic compliance. The
Alpha-Stim® PPM is not yet approved for sale in Europe.
Caution
statement for United States
Federal Law (USA
only) restricts this device to sale by, or on the order of a
licensed health care practitioner. Outside of the USA it is
available world wide without a prescription but consultation
with a qualified health care professional is recommended for
difficult and unresponsive problems or when used in conjunction
with pharmaceuticals or other therapeutic intervention.
Indications
Alpha-Stim® 100,
Alpha-Stim® SCS, and Alpha-Stim® PPM microcurrent electrical therapy
(MET) and cranial electrotherapy stimulation (CES) technology
is continuously being subjected to rigorous study and evaluation
by the international medical community. Findings to date indicate
that the Alpha-Stim® 100 and Alpha-Stim® PPM (MET) are effective
treatment with broad applications for a variety of syndromes
involving pain, or for the short term relief of the symptoms
of pain, and the Alpha-Stim® 100 and Alpha-Stim® SCS (CES) are
effective treatment with broad applications for the management
of anxiety, depression, and/or insomnia, or for the short term
relief of the symptoms of anxiety, depression and/or insomnia.
In many cases it is the sole therapeutic method required. Effective
results in pain management have been seen during and/or subsequent
to stimulation over affected body parts, adjacent areas, and
areas distant from those in pain. As with any therapeutic intervention,
not all people will respond to the Alpha-Stim® 100, Alpha-Stim®
PPM or Alpha-Stim® SCS. The degree of efficacy will vary with
the nature of the problem being treated, the overall health
of the person, and with the method of treatment.
Contraindications
The Alpha-Stim®
100, Alpha-Stim® PPM or Alpha-Stim® SCS may affect the operation
of cardiac pacemakers (particularly demand type pacemakers).
Do not stimulate directly on the eyes, or over the carotid sinus
(on the neck beside the larynx).
Precautions
For external use
only. Do not allow children to use or handle these devices without
adult supervision. Do not operate potentially dangerous machinery
or vehicles during, and in some cases, for several hours after
treatment with the Alpha-Stim® 100 or Alpha-Stim® SCS (CES). Caution
is advised in cases where other forms of analgesia (pain control)
would not be used; such as to retain the beneficial aspects
of pain for diagnosis or in cases where people may overuse pain-controlled
areas. Safety of stimulation has not been established during
pregnancy. There have been isolated reports of blood pressure
being lowered by CES so care should be taken while using the
Alpha-Stim® 100 or Alpha-Stim® SCS with high blood pressure medication.
Adverse
effects (Alpha-Stim® 100 and Alpha-Stim® SCS)
Adverse effects
are usually mild and self-limiting. Adverse effects seen in
approximately 4,541 patients in controlled, open, uncontrolled
conditions, and by physician survey and reasonably associated
with the use of CES are dizziness (6 cases, 0.13%), skin irritation/electrode
burns (5 cases, 0.11%), and headaches (9 cases, 0.20%). Prolonged
CES treatment at higher than necessary currents may cause dizziness
or nausea that can last from hours to days. Treatment immediately
prior to going to sleep may cause difficulty sleeping due to
increased alertness. It is recommended that CES be used at least
3 hours before going to sleep. Paradoxical reactions such as
hyperexcited states, increased anxiety, and sleep disturbances
may occur, but are rare.