2 Safety
5
EN
2.1
Reporting obligation
Users and/or patients must report any serious incidents that arise in relation to the product to the manufacturer and
the competent authorities in the country in which the user and/or patient is resident.
2.2
Warning signs
Structure of warning sign
HAZARD SYMBOL
Nature or source of hazard
Description of the nature or source of hazard and its possible consequences.
Measures to avoid the hazard
Risk levels
Warning
Indicates a hazardous situation that could lead to serious or fatal injuries.
Caution
Indicates a hazardous situation that could lead to minor or moderate injuries.
Attention
Indicates a hazardous situation that could lead to property damage.
2.3
Risk of infection
Risk of infection
If the aerosol mist
in or in front of the patient’s oral cavity is not properly removed, this may lead to bacterial transmission
and cross-contamination in the treatment room. There is a risk that patients, users or third parties may be infected.
Take appropriate personal protection measures.
Observe the reprocessing requirements in these instructions for use.
Reprocessing may only be conducted by trained or qualified personnel.
The suction cannulas and cannula holder must be thermally disinfected and/or sterilized in autoclaves at a temperature
of up to 135°C each time a patient is treated.
Clean and disinfect the suction hoses and aerosol suction in accordance with the hygiene and reprocessing measures
specified by the treatment device/suction system manufacturer.
This aerosol suction does not replace the usual protective equipment of the practice staff.
2.4
Magnetic fields
Magnetic fields
Magnetic fields are created when operating the headphones with the magnetic fasteners. This may impact the functioning
of implants like pacemakers.
Before starting treatment, ask patients if they have any implants and inform them of the potential risks.
Do not place or put down the headphones or cannula adapter on the patient.
2.5
Risk of burns
Overheating
The headphone earpieces may heat up when using electrically operated scale removal devices. There is a risk of
overheating and a potential risk of burns. Also pay attention to the headphone batteries during charging. These may also
heat up.
Stop the electric scale removal device if you notice unexpected overheating.
Before each treatment, check that the headphones are in a perfect technical condition and inspect them for any signs
of damage.
Only use properly functioning electrically operated scale removal devices with the headphones.