Orthofix AccelStim Manual De Instrucciones página 26

The essential performance of the AccelStim device includes the following:
•
Free from the display of incorrect numerical values associated with the therapy
to be performed.
•
Free from the production of unwanted ultrasound output.
•
Free from the production of excessive ultrasound output.
•
Free from the production of unintended or excessive transducer assembly
surface temperature.
COMPLIANCE STATEMENTS
Changes or modifications not approved by Orthofix could void the user's authority
to operate the equipment. These limits are designed to provide reasonable
protection against harmful interference in a residential installation. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation.
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 AccelStim device has been tested and certified as complying with the regulations
on electromagnetic compatibility (EMC) of medical devices and has been found
suitable for the "Home Healthcare Environment. " The AccelStim device can be used
in conjunction with other electrical or electronic devices, if they also conform to
current standards, without causing interference or interference. The following general
requirements need to be observed:
•
The AccelStim device should not be used adjacent to, or stacked with, other
equipment. If adjacent or stacked use is necessary, the medical electrical
equipment or medical electrical system should be observed to verify normal
operation in the configuration in which it will be used.
•
The AccelStim device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this
accompanying documents.
•
None of the device parts are field serviceable. Any unauthorized modifications to
the device or components will void the device warranty and compliance.
•
The use of accessories, transducers and cables other than those specified and
supplied may result in increased emissions or decreased immunity of the device
and result in improper operation.
•
Portable and mobile RF communications equipment, including peripherals such
as antenna cables and external antennas, should be used no closer than 30
cm (12 inches) to any part of the AccelStim device, including cables. Otherwise,
degradation of the performance of this medical device could result.
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