Physiostim Device Classifications; Compliance Statements - Orthofix PhysioStim 5302 Manual De Instrucciones

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
Orthofix#: WR9QA1200U23KIT(R6B):
Input: 100-240VAC, 50-60Hz, 0.6A
Output Voltage: 5VDC, 1.2A
Orthofix # 20123807:
Input: 100-240VAC, 50-60Hz, 0.15A
Output Voltage: 5VDC, 1.2A

Compliance Statements

This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference
and (2) this device must accept any interference received, including
interference that may cause undesired operation.
IMPORTANT! Changes or modifications not expressly approved by Orthofix, Inc.
could void the user's authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits
for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 2.4A
Orthofix#: 20123808:
Input: 100-240VAC, 50-60Hz, 0.6-0.3A
Output Voltage: 5VDC, 1.2A
Orthofix # 20123810:
Input: 100-240VAC, 50-60Hz, 0.6-0.3A
Output Voltage: 5VDC, 1.2A
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