Cervicalstim Device Classifications; Compliance Statements - Orthofix CERVICALSTIM 5505CE 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

Hereby, Orthofix declares that the CervicalStim device Model 5505CE is in compliance
with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet
address: www.Orthofix.com
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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