5
4
Chapter 4: GENERAL DESCRIPTION
The AGF-5X DIGITAL SD TENS is a battery operated pulse generator that
sends electrical impulses electrodes to the body and reach the nerves caus-
ing pain. The device is provided with two controllable output channels, each
independent of each other. An electrode pair can be connected to each output
channel.
The electronics of the AGF-5X DIGITAL SD TENS create electrical impulses
whose Intensity, duration, number per second and modulation may be altered
with the controls/switches. Press buttons are very easy to use and the large
liquid crystal display showing the exact mode and values of parameters are
very convenient for patients.
Chapter 5 : CONSTRUCTION
LIQUID CRYSTAL DISPLAY
Chapter 3 : WARNINGS
1. Caution should be used in applying TENS to patients suspected of having heart
disease. Further clinical data is needed to show there are no adverse results.
2. The safety of TENS devices for use during pregnancy or birth has not been
established.
Do not use TENS during pregnancy.
3. TENS is not effective for pain of central origin. (This includes headache.)
4. TENS devices should be used only under the continued supervision of a
physician.
5. TENS devices have no curative value.
6. TENS is a symptomatic treatment and as such suppresses the sensation of
pain, which would otherwise serve as a protective mechanism.
7. Electronic monitoring equipment (such as ECG monitors and ECG alarms)
may not operate properly when TENS stimulation is in use.
8. There should be a prominently placed statement warning that stimulus deliv
ered by this device may be sufficient to cause electrocution. Electrical current
of this magnitude must not flow through the thorax because it may cause a
cardiac arrhythmia.
9. Do not place electrodes on the front of the throat as spasm of the Laryngeal
and Pharyngeal muscle may occur.
10.Care should be taken so that when operating potentially dangerous machinery
the stimulator controls are not changed abruptly.
6. Electrodes should not be placed over the eyes, in the mouth, or internally.
11. Keep this device out of the reach of children.
12.Caution: Federal law restricts this device to sale by or on the order of a physi-
cian.
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