The RCStim 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 less than 12.5 mm and dripping liquids
when tilted 15° from normal use. It is recommended you keep the unit dry.
• 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:
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz,
Input: 100-240VAC, 50-60Hz,
200mA
150-350mA
Output Voltage: 5VDC, 1.3A
Output Voltage: 5VDC, 2.4A
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
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
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