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Product Support
203-349-2798
Applicator
Input Voltage:
3.7 V DC +10%
Ultrasound Frequency:
3 MHz +20%
Ultrasonic Output Power:
1 Transducer: 0.65 W +20%
2 Transducers Together: 1.3 W +20%
Max Input Current:
400 mA
Y-Adapter
Voltage Rating
300 V
20°C Resistance
94/km
C. NOTICE OF COMPLIANCE, CALIBRATION AND
OPERATIONAL PERIOD
The
sam
Device meets performance standards under 21 C.F.R. § 1050.10 -
PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-
EMITTING PRODUCTS. The
sam
Device meets IEC 60601-1, 3 ed. (2012); IEC 60601-
1-2, 3 ed. (2007); Medical Electrical Equipment, General Requirements for Safety;
Electromagnetic Compatibility. The
sam
Device is calibrated to provide 3 MHz +20%
ultrasound diathermy at 0.65 W +20% per ultrasound applicator.
Operational Period:
The
sam
Power Controller Module is intended to maintain calibration for up to 300
charging cycles and each ultrasound applicator is intended to withstand 1500 hours
of run time, after which the system should be recycled or returned to ZetrOZ, Inc. for
proper disposal.
