Cervicalstim Device Classifications; Compliance Statements - Orthofix CervicalStim 5505CM Manuel D'instructions

CervicalStim Device Classifications

• Product Family Name: Orthofix PEMF Device
• Internally powered equipment. The service life of the non-replaceable
lithium-ion battery is 2.5 years.
• 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 12.5 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.
• Shelf life for equipment: 1 year
• 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#: 20123808:
Input: 100-240VAC, 50-60Hz, 0.6-0.3A 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 Industry Canada licence-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.
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 2.4A
Orthofix#: WR9QA1200U23KIT(R6B):
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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