Compliance Statements - Orthofix SPINAL STIM 5212CE Manual De Instrucciones

Compliance Statements

Hereby, Orthofix declares that the SpinalStim device 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.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Information regarding Electromagnetic Compatibility and Immunity
The SpinalStim device complies with IEC 60601-1-2 for electromagnetic
compatibility (EMC). The SpinalStim device needs special precautions regarding
EMC and needs to be used in accordance with the EMC information provided
in this manual. Wireless communications equipment such as home network
devices, mobile phones, cordless telephones and their base stations, and
walkie-talkies can affect the SpinalStim device. These types of equipment should
be kept at least 0.198 m (7.8 in) away from the SpinalStim device.
The SpinalStim device has not been evaluated with regard to use with specific
implantable electronic medical devices. Please consult your physician prior to
use of the SpinalStim device with implantable electronic medical devices.
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