Kernel Flow1 - IMPORTANT NOTICES

PLEASE READ THE FOLLOWING SAFETY NOTICES

LASER SAFETY

Image: Class 2 Laser warning sticker

The Kernel Flow complies with Federal Laser Product Performance Standards (FLPPS) 21CFT1040.10 as a Class 2 laser product. A Class 2 laser means any laser product that permits human access to levels of laser radiation in excess of Class 1 accessible emission limits (AEL) during normal operation.

During Normal operation the Kernel Flow emits invisible (850nm) Class 1 laser radiation and visible (690nm) Class 2 laser radiation. The Kernel Flow utilizes 52 Class 1 diode lasers and 52 Class 2 diode lasers.

A Class 1 laser is considered to be incapable of producing damaging radiation levels during operation and is exempt from any control measures.

A Class 2 laser system emits in the visible portion of the spectrum (400nm to 700nm) and eye protection is normally afforded by the aversion response. The aversion response is defined as closure of the eyelid, eye movement, pupillary constriction, or movement of the head to avoid an exposure to noxious or bright light stimulant. The aversion response to an exposure from a bright, visible, laser source is assumed to limit the exposure of a specific retinal area to .25 s or less.

The Kernel Flow is designed to be positioned on the user prior to activation. Users should not intentionally stare into/or at the visible red beams.

CAUTION

Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.

DEVICE IS NOT USER-SERVICEABLE

Do not open or attempt to service modules. Modules must be returned to manufacturer for service or repair.

Any misuse or mishandling of the product, including failure to properly clean and store the product, will void the warranty.

Kernel Flow has not been evaluated for clinical performance or use, accuracy, reliability, or effectiveness, and has not been validated for any particular use.

FOR RESEARCH USE ONLY

Not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease.

Kernel Flow 50 is a pre-production prototype that currently has not been tested for electrical safety, electromagnetic compatibility, or biocompatibility.