ProMedTek Replexa+ Instruction Manual

Device Description
Replexa+ is a shortwave diathermy device that delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic
effects to body tissues. Replexa+ consists of a Generating Unit (Device) and Treatment Applicator. The Replexa+ Treatment Applicator
is Non-Sterile and designed for Single Patient Use only.
Indications for Use
When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be
used to treat selected medical conditions such as:
Relieving pain.
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Reducing muscle spasm.
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Increasing range of motion of contracted joints using heat and stretch techniques.
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Increasing blood flow to tissues in the treatment area.
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Replexa+ is a prescription device for sale and use by a licensed health practitioner.
Caution: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).
CONTRAINDICATIONS
Shortwave diathermy must not be applied over areas of the body that may contain metal (implants, surgical staples, etc.) for heat will
become concentrated in that area increasing the possibility of tissue damage and deep burns.
Any patient with an implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes
for a myoelectric prosthesis, or implanted metallic leads, must not be treated with shortwave diathermy and should be at least 15
meters away from the vicinity of Replexa+ when it is in operation.
The following areas should not be treated with Replexa+:
Do not treat over the pelvic or low back area when an IUD is present.
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Shortwave diathermy should not be applied over the pregnant or potentially pregnant uterus. Therefore, shortwave diathermy
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should not be applied over the uterus unless specific assurance can be attained from the patient that she is not pregnant. If the
device operator is pregnant, she should remain at least 15 meters away from the applicator when the unit is turned on.
Shortwave diathermy should not be applied to the eye.
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Do not apply over or in close proximity to active cancer (except in terminal / palliative / hospice care), as therapy may increase
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blood flow to the tumor.
Shortwave diathermy should not be applied to the testes to avoid increases in temperature.
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Do not treat tissues in individuals where the blood supply would be unable to follow the increase in metabolic demand; tissue
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necrosis or hemorrhage might result.
Shortwave diathermy should not be applied over the epiphyseal areas (bone growth centers) of the bones of growing children.
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Do not apply shortwave diathermy if there are tuberculous joints or acute infections within the treatment area.
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WARNINGS
Always keep cables spaced apart. Keep cables at least several inches away from metal or grounded objects.
All equipment and accessories should be kept out of the reach of children or unqualified persons.
Do not apply over areas of hemorrhage or active bleeding.
Hearing aids should be removed during shortwave diathermy treatment.
Do not allow any liquids to penetrate the unit or its accessories while cleaning and disinfecting. Dry all sockets and connectors that
have become wet before any further use.
PRECAUTIONS
Federal law restricts the sale of this device to, or on the order of a physician or any other practitioner licensed by law of the state in
which he practices, to use or order the use of this device.
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to
radio frequency energy. Treatment should be administered only under the direct supervision of a health care professional.
Any bleeding tendency is increased by heating because of the increase in blood flow and vascularity of the heated tissues. Care,
therefore, should be used in treating patients with therapeutic shortwave diathermy who have bleeding disorders.
Heating of the joint capsule in acute or subacute arthritis should be avoided.
INSTRUCTION MANUAL