Device Specifications
The INDIGO Biofeedback System includes Device Box, Head and Limb Harness, INDIGO Software as well as Instructions for Use.
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.
Minimum Computer Specifications
Apple computers are not recommended as there have been issues with Parallels and Virtual PC’s.
- Windows XP Home or Professional 32bit (SP3) 2GB RAM
- Windows Vista (SP2) 3GB RAM
- Windows 7 - 3GB DDR2 RAM
- CPU Dual Core, Speed 2.2GHz, 2mb Cache (not Sempron or Celeron CPU’s)
- 60 + GB Hard Drive 5400rpm
- Desktop: 17” Flat Panel Display - 1280 x 1024 Screen Resolution
- Laptop / Notebook: 15.4” + Wide Screen - 1280 x 1024 Screen Resolution
- DVD ROM or DVD/RW Drive
- Dedicated or Discrete Graphics / Video Card 512MB
- Three USB 2.0 Ports
- Microsoft Word or Open Office Suite Software Program
- Internet Access
Make sure your computer is updated to the latest Windows Service pack. SP3 for Windows XP, SP2 for Vista or you will have problems with the software.
Be familiar with how to access your internet/online functions as activation and software updates are now being done online.
INDIGO Biofeedback System Disclaimer
The intended use of the INDIGO Biofeedback System is a therapeutic intervention for the treatment, modification, and alleviation of stress, as well as muscle re-education, relaxation training, brainwave relaxation training and pain management. Qualified professionals may legally practice biofeedback as long as they do not make claims or imply that the INDIGO Biofeedback System can do anything outside of its intended use.
It is important to monitor the effects of the INDIGO Biofeedback System, and to continue as long as it is beneficial. Research shows while many people benefit from the INDIGO Biofeedback System, some do not gain any benefit.
It is illegal in the US, Canada and most other jurisdictions in the world for unlicensed practitioners to diagnose, treat, cure or prevent any medical or psychological disease, disorder or condition. The INDIGO Biofeedback System is not a substitute for standard medical, chiropractic or psychotherapy treatment. It is important to stay in close communication with a physician, and obtain permission to undergo biofeedback training if using a pacemaker or experiencing any other medical condition that may be exacerbated by relaxation.