Interferences With Other Medical Devices; Using Accessories Not Supplied By; Prohibited Uses; Irrigation Systems Of The Medical Devices - Ultradent Products ultrawave XS Manuel D'utilisation

4.1 Interferences with other medical devices

Interferences may occur when the system is used on patients fitted with a pacemaker.
The medical device presents potential risks due to the emission of electromagnetic fields.
It may in particular cause malfunction of implanted devices such as a pacemaker or implantable defibrillator and,
generally, of any type of active implant:
• before using this product, check whether patients and practitioners are fitted with a device of this type;
• explain the situation;
• weigh up the benefits versus the risks and contact your patient's cardiologist or another qualified health
professional prior to starting treatment;
• keep this system away from implantable devices;
• apply suitable emergency measures and act fast if the patient shows signs of being unwell.
Symptoms such as an increased heart beat, irregular pulse or dizziness may indicate a malfunction
of a pacemaker or an implantable defibrillator.
The medical device is not designed to withstand electrical defibrillation shocks.

4.2 Using accessories not supplied by

The medical device was designed and developed with its accessories to guarantee maximum safety and
performance. The use of accessories from another source could put you and your patients at risk and could damage
your medical device. Do not try to connect accessories not provided by to your medical device connector(s) or to the
handpiece. Even if the manufacturer or dealer of your accessory claims full compatibility with equipment, it is advisable
to exercise caution with regards to the origin and safety of the product offered. Look out in particular for lack of
information, information in a foreign language, very attractive prices, suspect appearance, mediocre quality or
premature wear. If necessary, contact an approved dealer or the customer services department.

4.3 Prohibited uses

• Never cover the medical device and/or obstruct the air inlets.
• Do not immerse or use outside.
• Do not place the medical device next to a source of heat or in direct sunlight.
• Do not expose the medical device to water spray or mist.
The medical device is not designed to operate near a source of ionizing radiation.
A hot/cold temperature contrast can cause condensation to form in the medical device, which may be dangerous. If
the medical device needs to be moved from a cold place to a warm place, do not use the device immediately but wait
until it reaches room temperature.
The medical device may not be stored or used outside the atmospheric pressure and temperature ranges
recommended in the User Manual supplied with your medical device.
Do not touch accessible electrical connections.

4.4 Irrigation systems of the medical devices

This concerns medical devices that use tanks, bottles or bags.
• Never fill an irrigation solution tank or bottle when they are installed on the medical device.
• Always remove the irrigation tanks or bottles from the medical device before filling them.
• Never fill an irrigation solution tank or bottle over the maximum level mark.
• Irrigation tank covers must always be closed when the medical device is in use.
• Use the medical device with bottles or bags that do not exceed the maximum levels recommended for the medical
device (depending on option).
• To prevent any interaction such as crystallization or precipitate between the different irrigation
solutions used, rinse through the irrigation circuit and clean the tank in accordance with the
instructions provided in the medical device User Manual.

4.5 Assembly and disassembly

Unless otherwise indicated in the instructions specific to your medical device:
• Control devices are not designed to be removed or disassembled.
• Access doors and/or flaps are not designed to be removed or disassembled.
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J00039 • V3 • (13) • 12/2013 • RB77US030D