Indigo Device Specifications
The INDIGO Biofeedback System includes Device Box, Head and Limb Harness, INDIGO Software as well as Instructions for Use. The INDIGO Biofeedback System Device Box itself is designed of durable metal casing, and has a laser engraved test tray on top, which allows for frequency exchange
Activation and software updates are being done online.
It comes with washable straps and harness for specific electro-sensor placement on wrists, ankles and head.
The following is taken from the FDA website under Section 882.5050 , it describes the classification and registration of the INDIGO Biofeedback System as indicated for use.
Sec. 882.5050 Biofeedback Device
(a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.
INDIGO Biofeedback System Includes
The INDIGO Biofeedback System includes Device Box, Head and Limb Harness, INDIGO Software as well as Instructions for Use. The INDIGO Biofeedback System Device Box itself is designed of durable metal casing, and has a laser engraved test tray on top, which allows for frequency exchange.
It comes with washable, temperature sensing straps and harness for specific electro-sensor placement on wrists, ankles and head.
Device Box engineering specifications include
| INDIGO | Description | Specifications | Features |
|---|---|---|---|
| Transfer Rate | Bidirectional PC - INDIGO | 115,200 bps | Graphic LCD screen |
| Sensitivity | ADC | 16 bit (0.0000763 mV) | Auto Jack Sensing |
| Frequency Range | Output frequencies available | 1 - 5 MHz | Simultaneous Input / Output |
| Amplitude Range | Voltage output available | 0 - 5 Vmax | Fast on the fly switching from input to output |
| Dimensions | Weight 970 grams | 3”” x 6.5” x 9” (approx) | All 12 channels bidirectional and programmable |
The LCD screen on the interface box is also touch screen.
There are three output jacks, and one input jack allowing for multiple accessories and attachments. The device is powered via USB through your computer, for use with a medical grade surge protector.