Mettler Electronics Sonicator Plus 930 - Safety Precautions

Mettler Electronics Corp.— Rev.J_09/13/17
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The Sonicator Plus 930 can provide electrical stimulation only, ultrasound only and
combination therapy with the premodulated and medium frequency waveforms. Add the
optional treatment cart to create a mobile treatment center for your office.
The Sonicator Plus 930 was certified by Intertek Testing Services to meet the requirements
for ETL Listing per the following standards:
 UL 60601-1 Standard for Safety Medical Electrical Equipment, Part 1:
General Requirements for Safety Second Edition.
 CAN/CSA C22.2 NO 601.1-M90 – Medical Electrical Equipment – Part 1:
General Requirements for Safety General Instruction No 1; Supplement 1;
1994 R(1997)
 IEC60601-2-5 – Safety of Ultrasonic Therapy Equipment
 IEC60601-2-10 – Safety of Nerve and Muscle Stimulators
In addition, the Sonicator Plus 930 meets the following standards for radio frequency
emissions:
 FCC Part 18
 IEC/EN 60601-1-2
Mettler Electronics Corp. has been certified by VTT Expert Services LTD to be compliant
with EN ISO 13485:2003 and MDD 93/42/EEC Annex II requirements. In addition, Mettler
is certified by DQS Medizinprodukte GMBH to be compliant with ISO 13485:2003
(CMDCAS) Canadian Medical Device requirements.
1.2 Introduction to This Manual
Read the contents of this manual before treating patients with the Sonicator Plus 930.
This manual has been written to assist you with the safe operation of the Sonicator Plus
930. It is intended for use by the owners and operators of the Sonicator Plus 930. The goal
of this manual is to direct the correct operation and maintenance of this unit.
The specifications and instructions presented in this manual are in effect at the time of its
publication. These instructions may be updated at any time at the discretion of the
manufacturer.
1.3 Safety Precautions
The Sonicator Plus 930 operates with high voltages. Qualified biomedical technicians with
training in ultrasound and neuromuscular stimulator service should perform servicing of
the Sonicator Plus 930 or it should be returned directly to the factory. To maximize safety
during use, the unit should be plugged into a grounded wall outlet. General safety
guidelines for medical electronic equipment should be followed.
To assure compliance with FDA, 21 CFR 1050.10 standards, the ultrasound portion of the
Sonicator Plus 930 should be calibrated and safety tested on an annual basis. This service
may be obtained from the manufacturer by sending the Sonicator Plus 930 in its original
shipping container to Mettler Electronics Corp., 1333 South Claudina Street, Anaheim, CA
92805, ATTN: Service Department. (Telephone toll free: (800) 854–9305, Alternate telephone
number: 1 (714) 533–2221) This service may also be performed by qualified biomedical
engineers or technicians trained in ultrasound calibration.