ABB PM3398B-6P-1-3P-E module controller

ABB PM3398B-6P-1-3P-E module controller

Technical data of product parameters

According to information submitted by Theranica Bio-Electronics Ltd, Israel, the Nerivio™
device is a neuromodulation device for the acute treatment of episodic and chronic migraine.
The device stimulates the peripheral nerves in the upper arm to induce conditioned pain
modulation. The Nerivio™ device is a wireless wearable battery-operated stimulation unit
controlled by a smartphone software application. Treatments with Nerivio™ are selfadministered by the user at the onset of a migraine attack. The system delivers low energy
electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns
off automatically. The device hardware consists of an armband intended to be worn on a PM3398B-6P-1-3P-E
user’s upper arm. The armband contains the electronic circuitry and the battery in a plastic
storage case as well as two electrodes that are attached to the interior of the armband and
placed against the user’s skin. The device is operated and controlled via software that is
installed and run on a user’s personal mobile device such as a mobile phone or tablet. The
plastic electronics case contains an on/off switch and an LED indicator. The Nerivio™ device PM3398B-6P-1-3P-E
can be used for 12 treatments of 45 minutes each. These treatments can be exercised over an
18-month period. Durable medical equipment (DME) is defined in section 1861(n) of the Social Security Act
and in Medicare regulations at title 42 Code of Federal Regulations (CFR) 414.202, and
means equipment, furnished by a supplier or a home health agency that meets the following
conditions:Once used, the Nerivio™ can support 540 minutes of treatments, or 12 treatments of 45
minutes, but only up to an 18-month period. The Nerivio™ device can be used up to an 18-
month period; therefore, the minimum lifetime requirement of three years is not met.
According to the Nerivio™ user manual, when there are no more treatments left, the device PM3398B-6P-1-3P-E
should be disposed. DME is a benefit for rental of equipment for use in the home

Product picture display

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