ProMedTek Replexa+ User manual

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.
•Reducing muscle spasm.
•Increasing range of motion of contracted joints using heat and stretch techniques.
•Increasing blood flow to tissues in the treatment area.
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.
•Shortwave diathermy should not be applied over the pregnant or potentially pregnant uterus. Therefore, shortwave diathermy
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.
•Do not apply over or in close proximity to active cancer (except in terminal / palliative / hospice care), as therapy may increase
blood flow to the tumor.
•Shortwave diathermy should not be applied to the testes to avoid increases in temperature.
•Do not treat tissues in individuals where the blood supply would be unable to follow the increase in metabolic demand; tissue
necrosis or hemorrhage might result.
•Shortwave diathermy should not be applied over the epiphyseal areas (bone growth centers) of the bones of growing children.
•Do not apply shortwave diathermy if there are tuberculous joints or acute infections within the treatment area.
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.

4110 N Scottsdale Rd #270 Scottsdale, AZ 85251 866.388.2410 v1116
Instructions for Use
The use of shortwave diathermy for heat therapy has the advantage of penetrating deeper than other conventional methods, such as
infrared lights, heating pads, and even microwave diathermy. The heat generated by shortwave diathermy induces a whole range of
physiological effects. It relaxes muscles, tendons and other connective tissues, and increases blood circulation in the treatment area.
When shortwave diathermy is applied in short, high-energy pulses, the depth of penetration is increased, having a particularly positive
effect on the blood circulation, while the temperature sensitive skin hardly feels the heat.
Replexa+ has been shown to be most beneficial when twice a day for 30 minutes per treatment.
An initial recommended setting has been pre-set by the manufacturer. For instructions to change the recommended setting, please
contact the ProMedTek service department at 866.388.2410 or your local dealer.
Turn on the Replexa+ Device
1. Connect the Power cord to a grounded wall receptacle.
2. Press the black POWER switch, located on the left side of the Device, to turn the Device on.
3. The screen on the Device will light up and provide step-by-step instructions.
Connect Treatment Applicator to Device Port
1. Place the Device close enough for the Treatment Applicator to easily reach the patient’s treatment site – must be within 8 feet.
2. Connect the Treatment Applicator cable to a Port on the front of the Device.
3. The Port indicator will light blue if the Treatment Applicator is properly connected to the Device port.
The Treatment Applicator must be connected to the Device Port to begin treatment.
Position the Treatment Applicator
1. Position the patient so they are resting comfortably and the treatment site is easily accessible.
2. Place the Treatment Applicator directly on treatment site.
a. The white side of the Treatment Applicator should face away from the treatment site. The black side of the Treatment
Applicator should touch patient.
b. The center of the Treatment Applicator should be focused directly over the principal site of treatment.
c. The weight of the body should not rest on the Treatment Applicator.
3. Secure the Treatment Applicator to stay in place for the duration of the treatment.
Start Replexa+ Treatment
1. Push the blue button to begin treatment.
2. The Screen will indicate “Treatment in Progress” and display remaining treatment time.
Connecting or disconnecting a Treatment Applicator during therapy will stop the treatment.
Stop Replexa+ Treatment
1. At the end of 30 minutes, treatment will automatically stop.
a. The Screen will indicate “Treatment Completed”.
b. You may either press the POWER switch to power off the Device or press the blue button to begin another treatment.
2. Although the Replexa+ treatment timer is set for 30 minutes, the clinician may manually discontinue treatment at any time by
pressing the blue button during therapy, which allows for treatment duration variability from 0 to 30 minutes.
a. The Screen will indicate “Treatment Stopped”.
b. You may either press the POWER switch to power off the Device, or press the blue button to begin another treatment.
c. The Device will always begin a new 30-minute treatment when started again.
3. When treatment is completed or discontinued, turn off the Device by pressing the POWER switch.
4. Remove the Treatment Applicator from the patient.
Cleaning and Storage
1. Treatment Applicator
a. Unplug the Treatment Applicator from the Device.
b. Wipe clean the Treatment Applicator and cables with a non-staining, water-based disinfectant.
c. Set aside that patient’s Treatment Applicator for next use (single patient use only).
2. Device
a. Unplug the Power cord.
b. Wipe clean the Device and Power cord with a non-staining, water-based disinfectant.
c. Set aside for next use.
Troubleshooting
1. If the screen indicates “Treatment Stopped,” but does not indicate maintenance required, check to make sure the Treatment
Applicator is connected to the Device Port. Then press the blue button to begin treatment. If treatment does not begin, call the
ProMedTek service department at 866.388.2410 for further instructions.
2. If the screen indicates “Maintenance Required,” call the ProMedTek service department at 866.388.2410 for further instructions.
3. There are no user-serviceable parts. All service needs must be addressed by ProMedTek.