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Prelivia

Prelivia is a novel innovation aimed at protecting patients from pressure injuries. It uses proprietary neurostimulation technology to continuously stimulate blood circulation and minimize pressure-induced tissue damage.

Rehabtronics Inc.

Rehabtronics aims to improve the lives of people with mobility impairments using neuroscience innovations. Prelivia, their newest product, is designed to transform pressure injury care.

Toll free:(800) 481-3214 Website: www.rehabtronics.com
Benefits

• Uses an innovative mechanism of intermittent electrical stimulation that maintains tissue oxygenation and tissue perfusion to prevent the development of pressure injuries 
• Provides a proactive and continuous approach to the management of pressure injuries, compared to traditional methods such as repositioning schedules, special mattresses and various creams

Indications

Prelivia has the following indications: increasing local blood circulation, prevention or retardation of disuse atrophy, relaxation of muscle spasms, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, prevention of venous insufficiency and ischemia, amd maintaining or increasing range of motion.

Contraindications

Prelivia has the following contraindications: pacemaker, any implantable electrostimulation device, myasthenia gravis, rhabdomyolysis, gluteal skin breakdown, unstable fractures at risk of displacement by stimulation, consumption of neuromuscular blocking drugs, or skin breakdown over treatment areas that would preclude the use of surface electrodes.

Warnings and Precautions

Warnings:
- The long-term effects of chronic electrical stimulation are unknown.
- Stimulation should not be applied over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex.
- Stimulation should not be applied over the neck, head, mouth or across the chest. Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing.
- Stimulation should not be applied over the eyes or temple.
- Stimulation should not be applied over areas of suspected or confirmed bone fracture.
- Stimulation should not be applied trans thoracically. Introduction of electrical current into the heart may cause cardiac arrhythmias.
- Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
- Simultaneous connection of a patient to a high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator.
- Operation in close proximity (e.g. 1 meter) to a shortwave or microwave therapy equipment may produce instability in the stimulator output.
- Stimulation should not be applied trans cerebrally.
- Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
- Stimulation should not be applied over, or in proximity to, cancerous lesions.
- Do not apply electrodes over wounds or to areas with known skin conditions that may be aggravated by the electrodes, gel or stimulation therapy.
- Do not connect the stimulator outputs or the electrode leads to any other device or power source. Damage to the stimulator and potentially serious injury or death may result.
- Electrodes are for single patient use only.
- Routinely inspect the electrode contact areas to monitor for excessive or unusual irritation, swelling, blistering or other adverse reactions that may indicate an intolerance to the electrode or stimulation therapy. Discontinue use of the stimulation system and consult a physician immediately if any of these effects are observed.
- Monitor the level of patient discomfort, adjusting the electrodes and/or the stimulation settings if required.
- Discontinue the use of the stimulation system if excessive discomfort occurs or if the level of discomfort increases significantly.
- Use only the recommended electrodes.
- Do not use this product on patients with pacemakers.
- Do not attempt to disassemble, modify or repair any components
- Do not apply leads around neck, there is a risk of strangulations or entanglement in leads
- Do not use this product on patients with suspected or diagnosed conditions of rhabdomyolysis or myasthenia gravis.

Precautions:
- Safety of powered muscle stimulators for use during pregnancy has not been established.
- Caution should be used for patients with suspected or diagnosed heart problems or epilepsy.
- Daily assessment of stimulation should be carried out, including assessing the set intensity, electrode placement, evoked responses and skin tolerance to the electrodes and stimulation.
- Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (electrode gel). The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement.
- Caution should be used in the presence of the following:
- When there is a tendency to hemorrhage following acute trauma or fracture;
- Following recent surgical procedures when muscle contraction may disrupt healing;
- Over the menstruating or pregnant uterus; and
- Over areas of the skin which lack normal sensation.
- Over areas where the skin is hypersensitive.
- Electrode positions and stimulation settings must be determined by the prescribing practitioner.
- Powered muscle stimulators should be kept out of the reach of children.
- Powered muscle stimulators should be used only with the recommended leads and electrodes.
- Be sure the Prelivia electrodes are applied to patient before plugging into leads.
- Portable powered muscle stimulators should not be used while driving, operating machinery, or during activities where involuntary muscle contractions may put the user at undue injury risk.
- Caution should be exercised when moving or manipulating a patient who is using the stimulator. If therapy is enabled, stimulation will occur without warning which may result in unexpected patient movement.
- Disable stimulation if the patient is going to stand. If stimulation occurs while a patient is standing, loss of balance or muscle control may occur, leading to a fall and possible injury.
- Use caution when touching the electrodes or adjacent areas. If stimulation occurs while the electrodes are being touched, part or all of the stimulation current may be redirected.
- Do not use the stimulator in the presence of combustible or flammable atmospheres.
- Do not use the stimulator in enriched oxygen environments.
- The system shall not be used in the presence of high magnetic fields.
- Keep areas of skin where electrodes are applied clean and free of oily lotions, ointments or other contaminates that may impair the adhesion of the electrodes or the delivery of stimulation.
- Do not store or operate the Prelivia in conditions outside those listed. Doing so can damage components.

Adverse Effects/Reactions

Physical Reactions:
- Pain or Discomfort
If used as directed, the Prelivia should not cause any pain, however mild discomfort is possible. In most cases, however, such discomfort is easily remedied by simply decreasing the stimulation intensity. If discomfort persists, discontinue use.
- Skin Irritation
Some reddening and indentation of the skin under electrodes is normal following a period of use, and further mild skin irritation may be experienced depending on factors such as the environment, duration of use, and patient skin-sensitivity. If any sort of skin irritation develops, remove electrodes and discontinue use until the symptoms have cleared.
- Allergic Reactions
Prelivia electrodes are designed to be biocompatible, hypoallergenic, and free of any toxic substances. Nevertheless, if allergic reaction to materials is suspected remove electrodes and discontinue use immediately.

Storage Requirements

The stimulator may be prepared for short-term storage simply by turning it Off. For long-term storage or shipment, remove the batteries. Do not leave batteries in the unit if it will
be stored for long periods as the batteries may gradually discharge and eventually leak.
Temperature: -25°C-70°C (-13°F-158°F)
Relative Humidity: 5% to 100% (non-condensing)
Pressure: 70 kPa to 106 kPa (10.2 psi to 15.4 psi)

Product features
check_circle Contact manufacturer for more details
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Pressure Ulcers

Mode of Use/Application

Stimulation delivery time is set for 10 seconds followed by 10 minutes rest. Continuous. This rhythm prevents muscle fatigue and discomfort while still providing benefits over time. It promotes better circulation, maintain optimal oxygenation, nutrient delivery and metabolic waste removal. Surface electrodes (2 pairs) are strategically positioned at pressure points prone to the development of pressure injuries to deliver this stimulation and can stay continuously for 24/7. Prelivia electrodes showed that they are safe even after 3 months of continuous use. They need to be changed if soiled, when a patient is having hygiene cleaning or as needed.

Warranty

2 years

Clinically Tested

Non-allergenic
Non-comedogenic
Non-cytotoxic
Non-irritating

Technical Specifications

Model- IES-1
Mode of Operation- Continuous
Applied Part Type- BF Applied Part
Power Supply / Type- 2 x 1.5V AA Alkaline Batteries. Internally Powered ME Equipment
Electrodes- Hydrogel Adhesive
Simulation OutputPulse
Shape: Rectangular
Pulse Width: 300 μs Pulse
Frequency: 30 Hz
Maximum Intensity: 100 mA
Maximum Output Voltage: 155 V
Maximum Chare per Pulse: 30 μC
Maximum Average Current: 1.82mA RMS (@500 Ω, 100mA)
Impedance Range*: 300 - 3000 Ω
Operating Conditions-
Temperature: 5°C-40°C (41°F-104°F)
Relative Humidity: 15% to 93% (non-condensing)
Pressure: 70 kPa to 106 kPa (10.2 psi to 15.4 psi)
Transport and Storage Conditions-
Temperature: -25°C-70°C (-13°F-158 °F)
Relative Humidity: 5% to 100% (non-condensing)
Pressure: 70 kPa to 106 kPa (10.2 psi to 15.4 psi)

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