13
Symbol for “ATTENTION,
CONSULT
ACCOMPANYING
DOCUMENTS
”
.
14
Class II Equipment.
15
Indoor use only.
16
RoHS Compliant Product.
17
Polarity of d.c. power connector.
10. SAFETY, EMC & BIOCOMPATIBILITY
10.1 Safety
The stimulator is Class II equipment to type BF applied part and complies with Medical Electrical
Safety Standards (IEC 60601-1, IEC 60601-2-10).
10.2 Electro Magnetic Compatibility (EMC)
Electrical Foot Massager and Nerve Stimulator
manufactured by Shenzhen OSTO Technology
Company limited conforms to this IEC 60601-1-2, 2001+A1: 2006 standard for both immunity
and emissions.
The parameters of basic characteristics (Power Source, Method of Line Current Isolation,
Patient leakage current, Average DC current through electrodes when device is on but no
pulses are being applied, Number of channels, Number of modes, Output Intensity Level,
Output Intensity, Indicator Display, Treatment Time) and output specification (Waveform and
Shape, Maximum Output Voltage, Maximum Output Current, Net Charge, Maximum Phase
Charge, Maximum Average Current, Maximum Current Density, Maximum Power Density,
Pulse Duration, Pulse Cycle, Frequency, Contraction and Relaxation time),
as well as all the functions of device, are essential performance.
Page 32 of 37