How-To Guide

P45
Chapter 6 References
Compliance Statement
L eltek productscom ply w ith internationaland nationalstandardsand law s.U sersare responsible
forensuring that the chosen sm artdevice and scannerare com pliant w ith the law in the
jurisdiction w here the product isused. L eltek m eetsallregulatory standardslistedinthischapter.
Leltek Ultrasound Imaging System
Authorized Representative
European Authorized R epresentative (AR ) N am e:
(R eserved)
Product Classification
Classification:
• T hedevicew ithtransducers:ClassIIa/internally pow eredM Eequipm ent.
• T ransducers:T ypeBFappliedparts,IP X 1
• O rdinary Equipm ent/ContinuousO peration
• N on-AP /AP G
Electromechanical Safety Standards Met
T hetransducersandsoftw arecom ply w iththerequirem entsofIEC 60601-1 M edicalElectrical
Equipm ent,GeneralR equirem entsforS afety,includingallapplicablecollateralandparticular
standards,asw ellasallapplicabledeviations.S ystem usersareresponsibleforensuringthatthe
chosendeviceiscom pliantw iththelaw inthejurisdictioninw hichtheproductisused.
Product Serial Number
(R eserved below )