Item Brochure

Safety, testing and certification. EC declaration of conformity and classification to
93/42/EEC annex IX
According to the Council Directive 93/42/EEC, the Vein-Eye Carry is a Class 1 medical
device and conforms to 93/42/EEC annex 1X. The Vein-Eye Carry is non-contact, non-
invasive, low voltage, minimal risk, and does not need to operate in a sterile
environment.
The Vein-Eye Carry has been tested and certified as safe. See Attachment B
TEST REPORT: 104473702BOX-001
Test Report Form Originator: Underwriters Laboratories Inc.
TESTING LABORATORY: Intertek Testing Laboratory, 70 Codman Hill Road,
Boxborough, MA 01719 USA (www.intertek.com)
TESTING REPORTS: General requirements for basic safety and essential performance.
The VEC has been tested and certified to be safe to the general public for basic safety
and essential performance according to the IEC 60601 2
nd
edition standards. All
applicable tests according to the below specified standards have been carried out.
· CAN/CSA C22.2 No 601.1-M90 (1990), 2nd Edition 'Medical Electrical Equipment,
Part 1: General Requirements for Safety'
· CENELEC EN 60601-1 (1990), 2nd Edition 'Medical Electrical Equipment, Part 1:
General Requirements for Safety' + A1(93) + A2(95)
· IEC 60601-1 (1988), 2nd Edition, 'Medical Electrical Equipment, Part 1: General
Requirements for Safety' + A1(91) + A2(95)
· UL 60601-1 (2003), 1st Edition 'Medical Electrical Equipment, Part 1: General
Requirements for Safety'
• ISSUED ON: 11-17-2020
• VALID TO: 11-17-2030 (4)