Summary Of Safety Notices; General Safety Statements; Warnings And Cautions - Tyco Healthcare AutoSonix Manual Del Operador

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Summary of Safety Notices

General Safety Statements

The AutoSonix™ System is an electro-mechanical device which, under certain circumstances, could present an electrical shock hazard to the
operator and/or patient. Please read the manual thoroughly and follow the directions stated herein to assure maximum safety during operation.
Since the AutoSonix™ System is intended to be used in various types of invasive surgical 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.
Ultrasonic Radiation Safety Statement
The AutoSonix™ System. complies with 21 CFR Subchapter J - Radiological Health.
Electrical Safety Statement
The AutoSonix™ System complies with the following international and national recognized standards:
EN 60601-1:1990 with Amd1, Amd2, Amd13 - Medical electrical equipment Part 1: General requirements for safety.
(IEC 60601-1:1998 with Amd1, Amd2 - Medical electrical equipment Part 1: General requirements for safety.)
- Equipment classification - Class 1, Type CF applied part.
IEC 60601-1-2:2001 - Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic
compatibility - Requirements and test.
UL 2601-1:1997 - Medical Electrical Equipment, Part 1: General Requirements for Safety.
CAN/CSA C22.2 No. 601-1 - Medical Electrical Equipment, Part 1: General Requirements for Safety.
ANSI/AAMI ES-1 - Safe Current Limits for Electrical Apparatus 3rd Edition.
IEC 529 - Degrees of Protection provided by enclosures (IP code). Footswitch IPX rating: IPX 68.

Warnings and Cautions

Please read this section of the manual carefully. It contains a summary of all warning and caution statements contained in the manual.
However, the user is advised to read the entire manual and operate the AutoSonix™ System only in accordance with all of the instructions
contained herein.
Servicing of the device should only be performed by qualified technicians authorized by United States Surgical. There are no service controls
accessible to the user.
Safety Recommendations for Use of the Device
CAUTION: Use only genuine replacement parts manufactured for United States Surgical. Use of parts furnished by other sources may
result in danger or failure and may void any warranty that may apply.
CAUTION: The AutoSonix™ ULTRA SHEARS™ instruments, Ball Probe and Hook Probe single use instruments are provided STERILE and
are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.
WARNING: DO NOT ENCLOSE THE GENERATOR HOUSING IN A BAG, OR DRAPE COVERING OVER IT WHILE IN OPERATION. AIRFLOW
MUST CIRCULATE THROUGH UNIT DURING USE IN ORDER FOR PROPER COOLING OF ELECTRONIC COMPONENTS.
CAUTION: Do not place generator on towel, foam or other soft surface since the material may block air vents located on the bottom of
the generator. Blocking these vents may cause generator to overheat and malfunction or create a shock hazard.
WARNING: PLUGGING GENERATOR UNIT INTO SOCKET WHICH SUPPLIES IMPROPER VOLTAGE MAY CAUSE GENERATOR TO
MALFUNCTION OR TO CREATE A SHOCK OR FIRE HAZARD. BE CERTAIN LINE INPUT VOLTAGE SELECTOR SWITCH IS
PROPERLY ADJUSTED.
WARNING: PROPER SYSTEM GROUNDING CANNOT BE ENSURED UNLESS UNIT IS CONNECTED TO PROPERLY WIRED HOSPITAL
GRADE OUTLET.
CAUTION: The generator should not be turned on until the patient cable has been connected to both the generator and transducer.
Otherwise, damage to the generator may result.
CAUTION: Ensure all connections and mating surfaces are clean and dry before assembly.
WARNING: CARE MUST BE TAKEN NOT TO DAMAGE THE PROBE. DO NOT GOUGE, NICK, SCRATCH, BEND OR KINK PROBES DURING
USE. DISCARD ANY PROBES WHICH SHOW SIGNS OF SUCH DAMAGE.
CAUTION: Do not hold the probe tightly while the power is on. Clamping the probe restricts the longitudinal motion, causing the probe
to heat at that point. Prolonged restriction may cause the probe to break. Restriction may also cause a mechanical limit
condition, causing ultrasonic energy to be inhibited. Undue bending of the probe may do the same. If both these conditions
are relieved, the mechanical limit condition will be cleared.
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