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Compliance Statements
Hereby, Orthofix declares that SpinalStim Model 5212CE 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.
SpinalStim 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 > 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:
Orthofix # 20114794:
Input: 100-240VAC, 50-60Hz, 200mA Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 1.3A
Output Voltage: 5VDC, 2.4A
