Item Brochure

Product verification
Our product verification process ensures that the product conforms within the design
specifications.
Testing data and reports, functionality studies, wet lab or bench top testing
The Testing data and report by Intertek is in Attachment B. In addition, Sparqtron
tests each component of the system and the entire system prior to shipping.
EMC testing and certificates
The Vein-Eye Carry has been tested by certified by Intertek based on IEC6061-2
safety standards. See Attachment B.
Compatibility studies (connection to other devices)
The Vein-Eye Carry system is a standalone device and should not be connected to
other devices.
Risk management documentation (EN ISO 14971)
The Company uses ISO 14971 (ISO 14971) for risk analysis, risk evaluation, risk mitigations,
and a residual risk analysis and management. There are no documents at this time.
Hazard Analysis
As part of our human factors engineering process, the Company conducts a hazard analysis
to identify potential hazards or hazardous issues from the environment and usability of the
device. We also analyze residual risk of the device.
(14)