Compliance Statements - Orthofix SpinalStim 5212CM Manuel D'instructions

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.
CAN ICES-3(B)/NMB-3(B)
This equipment complies with radiation exposure limits set forth for uncontrolled
environment.
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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