FB-618/AU – rev.E – ed.2019/08
Applied Parts
The following items are Medical Device Applied Parts:
• AIRFLOW
®
(EL-308) Handpiece
• PERIOFLOW
®
(EL-354) Handpiece
• PIEZON
®
(EN-060 and EN-061) Handpieces
Applied Parts, under certain operating conditions, may exceed 41°C of temperature and reach
a maximum temperature of 51°C.
1.7. General Precautions
USE EMS ACCESSORIES ONLY!
DO NOT use this device in the presence of flammable anesthetics or oxidizing gases (such as
nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether or alcohol),
as explosion may occur.
DO NOT store the powder near acids or heat sources.
TAKE the following precautions to prevent any adverse events to the patient and/or to the user
in case of electromagnetic disturbances:
• Always refer to the information listed in the chapter “
• Electromagnetic Compatibility”.
• In case of a wireless pedal malfunction, presumably caused by electromagnetic
disturbances, use the wired pedal instead.
• In case of a device malfunction, presumably caused by electromagnetic disturbances, first
verify the cabling, and then move any portable RF communications equipment and mobile
devices placed nearby as far away as possible to rule out interference.
• Stop using the device if the electromagnetic disturbances persist and contact EMS
technical support for assistance.
The use of any other accessories could lead to
patient injury, malfunction or damage to the device
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