Spinalstim Device Classifications; Compliance Statements - Orthofix SPINALSTIM 5212CM Manual De Instrucciones

SpinalStim 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 > 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 Input: 100-240VAC, 50-60Hz, 150-350mA
Output Voltage: 5VDC, 1.3A

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:
Output Voltage: 5VDC, 2.4A
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