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Product Support
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1. Introduction
Thank you for choosing the
sam
Ultrasonic Diathermy Device! This manual contains
general instructions for operation, application, precautions, and maintenance. In order
to obtain maximum life and effi
ciency from the
sam
Device and to assist in the proper
operation of the device, please read and understand this manual thoroughly. This
device is only to be used as directed in this manual.
sam
was developed as a next generation wearable ultrasound therapy system which
combines miniaturization technology into a small and portable ultrasound therapy
system. It is designed to work with the human body and maximize the safe and eff ective
delivery of long-duration therapeutic ultrasound. Simple to administer and operate on a
broad range of body types,
sam
allows the delivery of ultrasound treatment for up to
four hours. It operates at a preset frequency and allows the use of up to two applicators
simultaneously. Applicators are applied and secured to the surface of the body using
convenient
sam
Ultrasound Coupling Bandages.
The specifi cations put forth in this manual were in eff ect at the time of publication.
1.1. GENERAL SAFETY
Thoroughly read and understand the precautionary and operating instructions before
attempting to operate the
sam
Ultrasonic Diathermy Device. Know the limitations and
hazards associated with using any ultrasound device. Observe the precautionary and
operational decals placed on the device. Periodically review the operation procedures
and safety precautions outlined in this manual.
1.2. PRESCRIPTION USE ONLY
Caution: Federal law restricts this device to sale by or on the order of a practitioner
licensed by the law of the state in which he/she practices to use or order the
use of the device.
This device complies with 21 C.F.R. § 1050.10
2. Indications for Use
The
sam
Ultrasonic Diathermy Device is intended to apply ultrasonic energy to
generate deep heat within body tissues for the treatment of selected medical
conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint
contractures and the local increase of circulation.
The
sam
Ultrasonic Diathermy Device is a prescription use device.
sam
should only
be administered and monitored by a licensed healthcare practitioner.
