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Tampering with the AURA
Battery could result in a hazard, such as fire,
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explosion or shock.
By design, the AURA™ Monitor and its antenna emit radio frequency in the
13.56 MHz and 2.4 GHz bands. This may interfere with nearby medical or office
equipment. When using the AURA™ Monitor, closely monitor equipment in the
vicinity to verify normal operation.
The presence of other equipment operating in the same frequency bands used
by the AURA™ Monitor may interfere with communication. Interference can
occur even if the other equipment complies with the International Special
Committee on Radio Interference (CISPR) emission requirements. This RF
interference can be reduced by increasing the distance between the interfering
device and the AURA™ Monitor. If communication problems persist, refer to the
Troubleshooting section of this manual.
The use of any accessories with the AURA™ Monitor other than those specified
by Branchpoint Technologies in this manual may result in increased emissions
or decreased immunity of the AURA™ Monitor and may cause decreased
functionality or unintended operational behavior of the AURA™ Monitor.
The use of the AURA
Monitor around strong sources of electromagnetism and
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electric fields should be avoided.
For disposal of the AURA
Monitor Pack, follow applicable hospital procedures
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and local regulations or return the product to Branchpoint Technologies.
Improper disposal of products may pose biohazards or environmental
hazards.
During normal or single fault conditions, the AURA
Antenna may reach a
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maximum temperature of 43°C. There is a safety cutoff to prevent
temperature from exceeding this value and mitigate the likelihood of
detrimental clinical effects.
Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally.
Portable 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 AURA
ICP Monitoring System or AURA
Battery Charger,
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including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
The Emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
6. PRECAUTIONS
Do not disassemble, alter, or modify any parts of the AURA™ Monitor or AURA™
Data Receiver.
The AURA™ Monitor Pack shall not be placed in oxygen rich environments. Use
only the designated Branchpoint Technologies AURA™ Monitor and appropriate
software application to communicate with the AURA™ Sensor and AURA™ Data
Receiver.
The AURA™ Monitor is intended for use by or under the direction of healthcare
professionals only.
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