Contraindications - Coltene BioSonic US100R Guide D'utilisation

6
V. Environmental/Storage Conditions
Environmental Conditions
• Intended for indoor use
• Maximum altitude : 2000 m (6600 ft.)
• Temperature range:
5°C (41°F)
• Relative humidity:
50% @ 40°C (104°F)
Storage Conditions
The unit must be stored and transported within the
following conditions:
• Temperature range:
-40°C (-40°F)
• Relative humidity:
(non-condensing)
• Atmospheric pressure:
VI. Information for safety

Contraindications

The Biosonic US100R Ultrasonic Scaler should not be used for/on:
®
• Restorative dental procedures involving the condensation of
amalgam
• Surgical or endodontic procedures
• Patients highly susceptible to infections
• Patients with chronic respiratory problems
• Patients with dysphagia or swallowing difficulty with water
flow
• Patients with cardiovascular disease with secondary pulmonary
disease or chronic pulmonary disease due to a risk of aspiration
of MOs in biofilm
Precautions
• Persons fitted with cardiac pacemakers or any other intra-
corporeal active medical device (e.g. insulin pump, defibrillator,
etc.) have been cautioned that some types of electronic
equipment might interfere with the operation of such devices.
Although no instances of intra-corporeal medical electronic
device interference have ever been reported during use of the
Biosonic ® US100R Ultrasonic Scaler, we recommend that the
handpiece and cables be kept at least 6 to 9 in (15 to 23 cm)
away from any pacemaker or pacemaker leads during use.
Clinicians should contact the pacemaker manufacturer or
the patient's physician for detailed information about the
pacemaker.
40°C (104°F)
80% up to 31°C (88°F)
%
70°C (158°F)
100%
%
10%
1060 hPa
500 hPa
• During boil-water advisories, this product should not be
operated as an open water system (e.g. connected to a
public water system). A Dental Healthcare Professional should
disconnect the system from the central water source. When
the advisory Is cancelled, flush all incoming waterlines from
the public water system (e.g. faucets, waterlines and dental
equipment) in accordance with the manufacturer's instructions
for a minimum of 5 minutes.
• Use of the Biosonic
®
demineralized tooth structure, hypersensitive areas, veneers,
cast crowns and implants.
Cautions
Observe the following to avoid damaging the de-
vice or impairing performance:
• Use only inserts manufactured by COLTENE.
• Do not restrict air flow. Provide adequate
ventilation.
CAUTION!
• Do not subject unit to shock or impact.
• Do not place the unit on or next to a radiator
or other heat source.
• Do not attempt to sterilize the handpiece.
Warnings
To reduce the risk of minor burns:
• Do not operate the unit without water.
• Use cold (5-25 °C) (41 -77 °F) water only.
• Do not activate the unit for more than
WARNING!
10 minutes continuously.
• Do not touch the metal working tip of an
activated insert with bare hands.
To reduce the risk of electric shock:
• Do not modify the power cord.
• Do not immerse the unit in water.
• Class 1 device. To avoid risk of electric shock
this equipment should only be connected to
WARNING!
a supply mains with electrical earth.
• Use of a Ground Fault Interrupt protective
outlet is recommended.
To reduce the risk of explosion:
• Do not use in the presence of flammable
mixtures.
WARNING!
BioSonic Ultrasonic Scaler
®
US100R Ultrasonic Scaler may irritate