Byron LySonix 3000 - General Safety and Compliance; General Safety Statements; FCC Compliance Statements; Medical Device Safety Compliance

LySonix 3000
®
with PulseSelect™ Operation Manual
40-OM-0002 Page 4 of 43 Rev B
GENERAL SAFETY STATEMENTS
THE LySonix 3000
®
with PulseSelect
™
SHOULD ONLY BE USED BY QUALIFIED MEDICAL
PERSONNEL.
THE LySonix 3000
®
with PulseSelect
™
IS AN ELECTRO-MECHANICAL DEVICE THAT, UNDER
CERTAIN CIRCUMSTANCES, COULD PRESENT AN ELECTRICAL SHOCK HAZARD TO THE
OPERATOR AND/OR PATIENT. PLEASE READ MANUAL THOROUGHLY AND FOLLOW
DIRECTIONS STATED HEREIN TO ASSURE MAXIMUM SAFETY DURING OPERATION.
SINCE THE LySonix 3000
®
with PulseSelect
™
IS INTENDED TO BE USED IN VARIOUS TYPES
OF INVASIVE SURGERY PROCEDURES, THERE MAY BE INDIRECT DANGER TO THE
PATIENT SHOULD THE UNIT FAIL DURING THE PROCEDURE. THEREFORE, IT IS
RECOMMENDED THAT A COMPLETE SPARE SYSTEM BE AVAILABLE FOR USE AS A
BACKUP.
FCC STATEMENTS
The LySonix 3000
®
with PulseSelect
™
is designed and tested to comply with FCC regulations for
conducted and radiated emissions under 21CFR Subchapter J. It also has been designed and tested to
comply with EN 60601-1-2:2001 standards for Electrical Emissions and Electrical Immunity.
SAFETY STATEMENTS
The LySonix 3000
®
with PulseSelect
™
has been designed and tested to comply with UL 2601-1 and EN
60601-1 Medical Device Standards with respect to Electrical Shock, Fire and Mechanical Hazards.
Made in the USA
The LySonix 3000
®
with PulseSelect
™
is manufactured wholly in the United States of America.