Physiostim Device Classifications; Compliance Statements - Orthofix PHYSIOSTIM 5302CM Mode D'emploi

PhysioStim Device Classifications

• Product Family Name: Orthofix PEMF Device
• Internally powered equipment.
• This device generates a non-ionizing pulsed electromagnetic field with
an intensity of approximately 2 Gauss and frequency components in
the 1Hz-50KHz range. This field is distributed within and near the
treatment coil.
• Type BF applied part. The applied part is the treatment coil with integrated
control unit.
• IEC 60529 enclosure rating: IP22. IP22 means the enclosure provides
protection from solid objects greater than 12.5mm and dripping liquids
when tilted 15° from normal use. It is recommended you keep the unit
dry.
• Shelf life for equipment:1 year
• Mode of operation: intermittent operation
• This device is non-sterile. It does not require sterilization.
• Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or nitrous oxide.
• The power supply is considered double insulated with Class II construction
throughout.
• Power supply ratings:
Orthofix # 20110412:
Input: 100-240VAC, 50-60Hz, 200mA
Output Voltage: 5VDC, 1.3A

Compliance Statements

This device complies with Industry Canada license-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) this device may not
cause interference, and (2) this device must accept any interference, including
interference that may cause undesired operation of the device.
IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc.
could void the user's authority to operate the equipment.
CAN ICES-3(B)/NMB-3(B)
This equipment complies with radiation exposure limits set forth for
uncontrolled environment.
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 2.4A
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