Sam 271 - Compliance, Calibration, and Operational Period

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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 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 the manufacturer for proper
disposal.