This document describes the Intelect TENS device, a lightweight and portable medical device designed for symptomatic relief of chronic intractable pain, post-traumatic, and post-surgical pain. It utilizes low electric current to stimulate muscle nerves.
Function Description:
The Intelect TENS device offers three stimulation modes: Normal (N), Burst (B), and Modulation (M).
- Normal Mode: Produces a continuous train of impulses. The pulse rate (2 to 150 Hz) and pulse width (60 to 250 µs) are fully adjustable, making it versatile for various rate and width settings.
- Burst Mode: Delivers "bursts" of seven pulses, with two bursts delivered per second.
- Modulation Mode: Features a decrease/increase cycle of pulse width variation. For example, if set to a maximum output of 250 µs, the pulse width will decrease to 125 µs and then increase back to 250 µs over a 4-second period.
The device has two output channels, allowing for the stimulation of two different areas simultaneously using two pairs of lead wires. Each channel has an independent On/Off and Amplitude Control.
Important Technical Specifications:
- Channels: Dual channels, isolated between channels.
- Pulse Amplitude: 0 ~ 80 mA, adjustable (at 500 ohm load), equivalent to 0 ~ 40 volts.
- Pulse Frequency: 2 ~ 150 Hz.
- Pulse Width: 60 ~ 250 µs.
- Waveform: Asymmetric biphasic square pulse.
- Timer Control: Adjustable to 30 minutes, 60 minutes, or Constant.
- Power Supply: 9V DC square shape battery.
- Size (D x W x H): 1.0" x 2.4" x 3.6" (26 mm x 62 mm x 91 mm).
- Weight (including battery): 4.4 oz (126 g).
- Safety Standard: EN 60601-1, EN 60601-1-2, IEC 60601-2-10.
- Operation Ambient Temperature Range: 50 ~ 95°F (10 ~ 35°C).
- Operation Ambient Humidity Range: 20 ~ 90% RH.
- Storage & Transportation Temperature Range: 32 ~ 158°F (0 ~ 70°C).
- Storage & Transportation Humidity Range: 20 ~ 90% RH.
- All specified values have a ±10% tolerance.
Usage Features:
- Controls: The device features Amplitude Controls (ON/OFF and Intensity), Pulse Width Control, Timer Switch, Mode Switch, and Frequency Control. A lid covers the Mode, Timer, Frequency, and Pulse Width controls, which may be set by a medical professional.
- Battery Installation: Requires a fresh 9V alkaline or rechargeable battery. Users must ensure correct polarity matching the markings in the battery compartment.
- Electrode Connection: Lead wires connect to electrodes (standard 0.08 inch female connection) and then to the unit's output receptacles. It's crucial that no bare metal of the pins is exposed.
- Electrode Placement: Electrodes should be applied to clean, dry, and unbroken skin at the site indicated by a physician, ensuring firm and even contact.
- Adjustments:
- Mode Selection: Shift the "MODE" switch to select the physician-recommended stimulation mode.
- Pulse Width Adjustment: Turn the Pulse Width Control to adjust the pulse width (60-250 µs) as recommended.
- Frequency Adjustment: Turn the Frequency Control to adjust the frequency (2-150 Hz) as recommended.
- Timer Adjustment: Shift the TIMER switch to set the stimulation time (30 minutes, 60 minutes, or Constant).
- Channel Amplitude Adjustment: Slowly turn Channel 1 or 2 control clockwise to reach the recommended intensity.
- Turning Off: Turn both Channel Amplitude controls to off. Unplug lead wires by grasping the plug, not the cord.
- Portability: The unit is portable and can be clipped to a belt, shirt pocket, bra, or other clothing.
Maintenance Features:
- Electrode Care: Silicone rubber electrodes should be cleaned frequently with soap and water to avoid skin irritation and ensure good contact. They must be dried completely before use. (This procedure is not applicable for self-adhesive electrodes). Always use electrodes that meet EN60601-1 and EN60601-2 requirements, such as those with CE mark, or legally marketed in the US under 510(K) procedure.
- Electrode Cord Care: Clean electrode cords by wiping them with a damp cloth. Lightly coating them with talcum powder can reduce tangles and extend their life.
- Battery Replacement: Open the lid cover, extract the old battery, and replace it with a 9V alkaline or similar rechargeable battery, ensuring correct insertion.
- Storage: Keep the device in its carrying case and store it at room temperature.
Warnings and Precautions:
- Federal law (USA) restricts this device to sale by or on the order of a physician.
- Long-term effects of chronic electrical stimulation are unknown.
- Stimulation should not be applied over carotid sinus nerves, the neck or mouth (risk of airway closure), transthoracically (risk of cardiac arrhythmias), swollen/infected/inflamed areas, skin eruptions, or cancerous lesions.
- For external use only; do not use on the eye area.
- Use only under the supervision of a licensed medical practitioner.
- Safety during pregnancy or delivery has not been established.
- Electronic equipment like ECG monitors may not operate properly when TENS is in use.
- Apply electrodes to clean, dry, unbroken skin only.
- Do not use while driving, operating machinery, or during activities where involuntary muscle contractions could cause injury.
- Keep out of reach of children.
- Keep electrodes separate during treatment to prevent improper stimulation or skin burns.
- Caution for patients with suspected or diagnosed heart problems or epilepsy.
- Caution when there is a tendency to hemorrhage or following recent surgical procedures where muscle contraction might disrupt healing.
- Caution over menstruating or pregnant uterus, or areas of skin lacking normal sensation.
- Skin irritation or hypersensitivity may occur; using an alternate conductive medium or electrode placement may reduce it.
- Electrode placement and settings should follow the prescribing practitioner's guidance.
- Use only manufacturer-recommended leads and electrodes.
- Isolated cases of skin irritation may occur with long-term application.
- Effectiveness depends on patient selection by a qualified professional.
- If stimulation levels are uncomfortable, reduce amplitude and contact a physician.
- Possible adverse reactions include skin irritation or electrode burn, and allergic skin reaction to tape or gel.
Accessories:
- Self-Adhesive Electrodes: 4 PCS.
- 9 V Battery: 1 PC.
- Lead Wires: 2 PCS.
- Instruction Manual: 1 PC.
Warranty:
- Unit: One year (12 months) from the date of original consumer purchase.
- Accessories (lead wire, AC adapter, electrodes, carrying case, belt clip): 90 days from the date of original consumer purchase.
- To obtain service, a written claim must be made within the warranty period to Chattanooga Group or the selling dealer. Chattanooga Group is not liable for incidental or consequential damages.
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