Device Description - Motiva Flora Instrucciones De Uso

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PRECAUTIONS
The Motiva Flora Port Locator should only be used as indicated in this document.
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• Before use, read the instructions for use carefully.
• Failure to follow the safety instructions may damage the device and/or cause an injury
to the patient.
• Check Motiva Flora Port Locator for damage before use.
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• DO NOT expose the device to extreme temperatures (below -20 °C or above 39°C),
direct sunlight, or extreme humidity (80% or above).
• Hospitals and medical clinics are suitable environments to use the Motiva Flora
Locator, except for areas near high electromagnetic (EM) disturbances, other active
radiofrequency (RF) devices, or RF shielded rooms.
• Portable RF communication equipment (including peripherals such as antenna, cables,
and external antennas) should not be used closer than 1 meter (39 inches) to any part
of the Motiva Flora Port Locator, including cables specified by the manufacturer.
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Otherwise, degradation of the performance of this equipment could result.
• The emission characteristics of this equipment make it suitable for use in industrial areas
and hospitals; if it is used in a residential environment, this equipment might not offer
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adequate protection to radio-frequency communication services. The user might need
to take mitigation measures, such as relocating or re-orienting the equipment.
• DO NOT modify the device in any way.
• DO NOT use abrasive cleaners or solvents on the device.
• DO NOT use the device while it is being charged.
CONTRAINDICATIONS
• DO NOT use on patients who have implanted devices that could be affected by a
magnetic field (e.g., pacemakers, drug infusion devices, artificial sensing devices).
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DEVICE DESCRIPTION

The Motiva Flora Port Locator is a non-invasive electronic medical device that interacts
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exclusively with the Motiva Flora
port within the tissue expander. Motiva Flora
identification (RFID) wireless system comprising two components: tags and readers. The
Motiva Flora ® Port Locator (reader) has an antenna that emits radio waves and receives
signals back from the RFID tag.
® Tissue Expander product family to locate the injection
Port Locator uses a radiofrequency
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