This document describes the ProActive™ Alevia 2-in-1 Physiotherapy Device, a stimulator designed for pain relief and muscle stimulation. It offers two independent, controllable output channels, allowing for the adjustment of current parameters and intensity levels according to individual needs.
Function Description
The device provides both Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle Stimulation (EMS) therapies.
TENS (Transcutaneous Electrical Nerve Stimulation) works by transmitting small electrical pulses through the skin to underlying peripheral nerves.
- Conventional (high frequency) TENS aims to block pain signals from reaching the brain, thereby reducing the perception of pain.
- Low frequency TENS stimulates the release of endorphins, the body's natural pain-control substances. TENS is proven useful in pain management for many patients.
EMS (Electrical Muscle Stimulation) uses an external source (the stimulator, via wires and electrodes) to create involuntary muscle contractions. This mimics the electrical signals transmitted by the central and peripheral nervous systems during normal muscular activity. EMS can help improve and maintain muscle tone without actual physical activity, thus preventing atrophy.
The device is recommended for:
- Symptomatic relief of chronic intractable pain, acute post-traumatic pain, or acute post-surgical pain.
- Improving local blood circulation.
- Relief from muscle spasms.
Important Technical Specifications
- Channel: Two isolated channels.
- Power Supply: 1 x 9V battery, type 6F22.
- Waveform: Single square pulse.
- Pulse Duration: Adjustable from 30 to 350µs.
- Pulse Frequency: Adjustable from 1 to 150Hz.
- Treatment Time: 5 to 60 minutes.
- Amplitude: 0-40V(Vpp) (Large output 40V±10% at 500ohm load).
- Operating Conditions: 0°C to 40°C with a relative humidity of 30% - 75%, atmospheric pressure from 700 hPa to 1060 hPa.
- Storage Conditions: -10°C to 55°C with a relative humidity of 10%~90%, atmospheric pressure from 700 hPa to 1060 hPa.
- Dimensions: 110 x 65 x 30.2 mm.
- Weight: 139 g (with battery).
Usage Features
The device features a clear LCD display screen and intuitive controls for ease of use.
Device Components:
- Front: Display screen (LCD), Parameter increase/decrease buttons, Mode select button (M), Therapy site quick select button (S).
- Top: Channel 1 and Channel 2 lead wire sockets, Channel 1 and Channel 2 intensity controls.
- Back: Belt clip, Battery cover.
Instructions for Use:
- Insert the battery: Slide off the belt clip and battery compartment cover. Insert a 9V battery, matching polarities, then close the compartment.
- Connect electrodes to lead wires: Insert lead wire connectors into electrode connectors, ensuring no bare metal is exposed.
- Connect lead wires to the device: After ensuring the device is off, insert wire plugs into the sockets at the top. The device has two output channels for simultaneous or individual use with electrode pairs. Always use supplied lead wires.
- Place electrodes on skin: Ensure skin is clean and dry. Apply electrodes firmly and evenly to the prescribed site.
- Turn the device on: Rotate either channel's intensity control clockwise until the device beeps.
- Select therapy program (mode) and site: Press 'M' to select the desired mode (EMS or TENS) and body part. The selected mode will flash on screen.
- Set pulse width and rate: Press 'S' to enter parameter setting mode. Use arrow buttons to adjust pulse width, then press 'S' again to adjust pulse rate, according to physician/therapist instructions.
- Set treatment time: Press 'S', then use arrow buttons to adjust the treatment time.
- Adjust intensity and begin treatment: Slowly turn intensity control dials clockwise to the prescribed setting. Adjust as needed for comfort. Rotate dials counter-clockwise to decrease intensity or turn off.
- After treatment: Once time elapses, turn intensity controls to "OFF". Unplug lead wires. Remove electrodes by lifting an edge and gently peeling (do not pull on lead wires). Place electrodes on their liner and remove lead wire by twisting and pulling.
- Consult memory: With the unit off, press and hold 'M' and turn one intensity control knob to enter memory mode. 'M' will display. Use arrow keys to navigate records and 'S' to switch data. Press quick select to clear memory. The device stores up to 30 records, deleting the oldest when full.
- Turn off: Rotate both intensity controls to "0".
- Low battery indicator: A flashing indicator means the battery should be replaced soon, though the stimulator will operate for several hours. Replace if stimulation seems weaker.
Therapy Programs:
The manual provides detailed tables for TENS and EMS programs, including:
- TENS Programs: Burst, Normal, Modulated (Mod.), SD1, SD2, Shoulder, Lower Back, Elbow, Knee. Each program specifies Time, Rate, Width, and Wave description (e.g., 9 pulses/burst, continuous, modulated intensity/pulse, 12-second cycles, etc.).
- EMS Programs: A, S, D. Each specifies Time, Rate, Width, and Wave description (e.g., 6-second cycles, 8-second cycles, 11-second cycles with rest periods).
Maintenance Features
Cleaning and Maintenance:
- Stimulator: Remove battery before cleaning. Wipe with a soft, slightly moistened cloth, possibly with mild soapy water. Do not submerge or expose to large amounts of water. Avoid chemical cleaners or abrasives. Store in its foam-padded carrying case. Remove battery for prolonged storage and store in a cool, dry place.
- Electrodes: Use only ProActive™ brand 4cm x 4cm (or larger) self-adhesive square electrodes. Inspect before each use and replace as needed, as reuse can cause skin irritation, low adhesion, or ineffective stimulation. Store between uses in the resealed bag in a cool, dry place. Moistening adhesive surface with a few drops of water (not over-saturating) and air-drying can help them last longer.
- Electrode Cords: Clean by wiping with a damp cloth. Lightly coating with talcum powder can reduce tangles and prolong life.
- General Maintenance: Do not attempt repairs. Contact AMG Medical Inc. for repair information. Check device for wear/damage before each use.
Skin Care Recommendations:
- Clean, rinse, and dry the treatment area thoroughly before and after applying electrodes.
- Clip excess hair with scissors; do not shave.
- A skin prep solution may be recommended by a doctor/therapist.
- Avoid stretching electrodes over the skin; apply from the center outward.
- Remove electrodes in the direction of hair growth.
- Apply skin lotion over the treatment area when not using electrodes.
- Never apply electrodes over irritated or broken skin.
Disposal:
- Used, fully discharged batteries must be disposed of in specially labeled collection containers, at toxic waste collection points, or through an electrical retailer.
- Dispose of the device in accordance with the directive 2002/96/EC WEEE (Waste Electrical and Electronic Equipment). Contact your local distributor for disposal information.
Storage:
- Remove the battery if not in use for long periods.
- Store in a dry place, protected from heat, sunshine, and moisture.
- Never place heavy objects on the device.
Safety Information (Warnings and Precautions):
- Contraindications: Do not use with undiagnosed pain syndromes, cancerous lesions in the treatment area, swollen/infected/inflamed areas or skin eruptions, implanted pacemakers/defibrillators, epilepsy, serious arterial circulatory problems in lower limbs, abdominal/inguinal hernia. Safety not established for pregnancy. Not effective on pain of central origin.
- Warnings: For external use only. Use under supervision of a licensed medical practitioner. Do not apply over thyroid or carotid sinus regions. Do not use with high-frequency surgical equipment or near shortwave/microwave therapy. Avoid high humidity environments. Never place electrodes on the front of the thorax or transthoracically (risk of ventricular fibrillation, cardiac arrhythmia, cardiac arrest). Do not allow current to flow through the head. Never use near eyes, genitals, heart, or areas lacking normal sensation. Keep out of reach of children.
- Precautions: Do not adjust controls while operating machinery or vehicles. Turn off before applying/removing electrodes. Use only ProActive™ lead wires and electrodes. Long-term stimulation at the same site may cause skin irritation. Avoid use in rooms with aerosols or pure oxygen, or near flammable substances/gases/explosives. Apply electrodes to clean, dry, unbroken skin only. Keep electrodes separate during treatment to prevent improper stimulation or burns.
- Adverse Reactions: Skin irritation, electrode burns, or allergic reactions to electrode gel may occur.
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