Terason t3000 - Compliance and Approvals; System Warranty

Chapter 12 - System Safety and Maintenance Compliance and Approvals
Terason t3000 / Echo Ultrasound System User Guide 285
Do Not Submerge Transducers Above Line
Compliance and Approvals
The Terason Ultrasound System is in compliance with the following:
• CE Marking: Medical Device Directive, 93/42/EEC (Annex II)
• EN 60601-1 Medical Electrical Equipment – General Requirements for Safety
• IEC 60601-1 Medical Electrical Equipment – General Requirements for Safety
• IEC 60601-1-1 Collateral Standard: Safety Requirements for Medical Electrical
Systems
• UL Std. 60601-1, “Medical Electrical Equipment General Requirements for Safety”;
CAN/CSA C22.2 No. 601.1-M90 “Medical Electrical Equipment, General
Requirements for Safety.”
• Electromagnetic Compatibility: EN60601-1-2, (CISPR11) Group 1, Class B
• Electric Shock: IEC 60601-1, Class I, Type BF
System Warranty
The warranty period for the Terason Ultrasound System is twelve (12) months, but you
can purchase an extended warranty. To obtain warranty service, U.S. customers call
Terason at 1-866-TERASON (1-866-837-2766); International customers call 781-270-
4143.
The warranty on the Terason Ultrasound System is voided if unauthorized personnel
perform service or maintenance on the ultrasound system, except for those service or
maintenance actions specifically designated for local service technicians. To ensure
correct system performance and to protect your warranty, contact Terason for service.