FDA 510k
Transcutaneous Electrical Nerve Stimulator
Operation Manual
TABLE CONTENTS
GENERAL DESCRIPTION |
1 |
SYSTEM COMPONENTS |
1 |
WARRANTY |
1 |
INDICATIONS AND CONTRAINDICATIONS |
1 |
WARNINGS AND PRECAUTIONS |
2 |
DANGER |
3 |
ABOUT THE DEVICE |
3 |
THE DEVICE CONTROLS |
4 |
ATTACHING THE LEAD WIRES |
5 |
ELECTRODE SELECTION AND CARE |
5 |
TIPS FOR SKIN CARE |
5 |
CONNECTING THE DEVICE |
6 |
BATTERY INFORMATION |
7 |
CHANGING THE BATTERY |
7 |
CLEANING FOR YOUR DEVICE |
7 |
TROUBLESHOOTING |
8 |
TECHNICAL SPECIFICATIONS |
8 |
GENERAL DESCRIPTION
Electrotherapy has been proven an effective modality for pain control.
The BioTENS 2 is a dual-Channel TENS (Transcutaneous Electrical Nerve Stimulator) device indicated for chronic and acute pain applications. It has an advanced 8-bit micro processor, controlling output and function, delivering an accurate and effective set of treatment parameters to include intensity, duration, frequency, rate, mode, and length of treatment, with a turn of a knob or the change of a switch.
SYSTEM COMPONENTS
Your device may include the following components or accessories:
Unit
Carrying case
Lead wires / Electrodes
9-volt battery
Operation Manual
WARRANTY
This device carries a one-year conditional warranty from the date of purchase. The warranty applies only to the device and covers necessary parts and labor. The distributor reserves the right to replace or repair the unit at their discretion.
The warranty does not apply to electrode, battery, lead wires, carrying case, damage resulting from failure to follow the operating instructions, accidents, abuse, alterations or disassembly by unauthorized individuals.
INDICATIONS AND CONTRAINDICATIONS
Read the operation manual before using the device.
Federal law (USA) restricts this device to sale by or on the order of a physician. Observe your physician’s precise instructions and let him show you where to apply the electrodes. For a successful therapy, the correct application of the electrodes is an important factor.
Carefully write down the settings your physician recommended.
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Indications for use
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Contraindications
Any electrode placement that applies current to the carotid sinus (neck) region.
Patients with implanted electronic devices (for example, a pacemaker) or metallic implants
Any electrode placement that causes current to flow transcerebrally (through the head). The use of unit whenever pain symptoms are undiagnosed, unit etiology is determined.
The use of TENS whenever pain syndromes are undiagnosed, until etiology is established.
WARNINGS AND PRECAUTIONS
Warnings
The device must be kept out of reach of children.
The safety of device for use during pregnancy or delivery has not been established.
Do not place electrodes on front of the throat. This may result is spasms of the laryngeal and pharyngeal muscles.
Do not place the electrodes over the carotid nerve.
The device is not effective for pain of central origin (headaches).
The device may interfere with electronic monitoring equipment (such as ECG monitors and ECG alarms).
Electrodes should not be placed over the eyes, in the mouth, or internally.
TENS has no curative value.
TENS devices should be used only under the continued supervision of a physician.
TENS is a symptomatic treatment and as such suppresses the sensation of pain which would otherwise serve as a protective mechanism.
Do not recharge alkaline batteries.
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