Adverse Events; Preparations For Use - Radi PressureWire Aeris Manual

- The PressureWire® Transmitter housing is protected against the effects of a
discharge of a cardiac defibrillator. PressureWire
affected by defibrillation. Attempt recalibration
of PressureWire
Preparation for use.
- Avoid abrasion of PressureWire
possible shearing of the polymer coating, do not withdraw or manipulate
PressureWire
- If PressureWire
into the patient make sure the PressureWire
meantime. Make sure that the transmitter is kept dry.
- For optimal pressure measurement adjust the position of PressureWire
that the sensor does not touch the atrial or ventricular walls, to avoid
measurement artefacts due to movement.
- After use, the product may be a potential biohazard. Handle and dispose of
PressureWire
and federal laws and regulations.
NOTE:
The transmitter contains silver oxide button type batteries with in total < 2% mercury,
allowed to be put on the market according to the battery directive 2006/66/EG.The
signal performance requires the batteries to be permanently affixed and the
transmitter to be sealed, which, according to article 11 in the same directive, exclude
the batteries from the requirement to be possible to remove. Dispose as ordinary
potentially biohazardous material.

5. ADVERSE EVENTS

Potential complications which may be encountered during all catheterization
procedures include but are not limited to: vessel dissection or occlusion,
perforation, embolus, spasm, local and/or systemic infection, pneumothorax,
congestive heart failure, myocardial infarction, hypotension, chest pain, renal
insufficiency, serious arrhythmias or death.

6. PREPARATIONS FOR USE

Open the PressureWire® package using sterile technique and place
PressureWire®, still attached to the packaging tray, on the sterile field.
- Make sure that PressureWire
- Fill the packaging coil with 10 ml (10 cc) of saline solution through the flush
port located at the very inside of the coil on the packaging tray.
®
after defibrillation according to "Recalibration" in the section
®
®
in a metal cannula or sharp-edged object.
®
is taken out during the procedure in order to be reintroduced
®
in accordance with medical practice and applicable local, state
®
is fully inserted into the transmitter.
®
readings may however be
coating. To avoid guidewire damage and
®
distal part is kept wet in the
®
so
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