ATS Dental BNE300 Instrukcja obsługi i konserwacji - Strona 4
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The device is not designed to work near ionizing radiation.
Do not insert metal objects into the device (risk of electric shock, short‐circuit or emission of hazardous substances).
Maintenance:
Before and after each use, your device must be disinfected with products recommended by the manufacturer.
Before each procedure, it is essential to make sure that the accessories to be used have been cleaned, disinfected. Do not use
agents containing phenol, per acetic acid, peroxide and other agents that break up the oxygen.
DO NOT (for any reason), lubricate the micromotor. After lubricating the handpiece, ensure that the lubricant does not
penetrate into the micromotor.
Accessories:
The device can only accept accessories distributed by ATS DENTAL for the particular use for which they are intended.
Use of accessories from other manufacturers is a potential hazard for you or your patients.
Repair:
Do not repair or modify the device without prior authorization from the manufacturer.
In the case of a fault, contact the supplier of your device. Do not use unauthorized repairers, who might make your device
dangerous for you and your patients.
If you have any doubt, contact an approved dealer or our customer support department:
Information concerning the accuracy and precision of this product may be obtained upon request by contacting:
ATS Dental srl Via Vecchia Provinciale Lucchese,49/F Serravalle Pistoiese – Italy
Tel: +39 0573 518137 [email protected]
2.2 Electromagnetic Interferences
To avoid possible risks of electromagnetic interferences do not use other electro‐medical instruments of similar nature near B‐
ONE. The unit complies with the current normative electromagnetic radiation law.
This device has been tested and found to comply with the emissions requirements of IEC 60601‐1‐2. These requirements
provide reasonable protection against harmful electromagnetic interference in a typical medical installation. However, high
levels of radiofrequency (RF) emissions from electrical devices, such as cellular phones, may disrupt the performance of this
device. To mitigate disruptive electromagnetic interference, position this device away from RF transmitters and other sources
of electromagnetic energy.
The device complies with applicable electromagnetic compatibility standards. The user should nevertheless ensure that any
potential electromagnetic interference does not cause an additional risk (presence of radiofrequency emitters, electronic
devices, etc.). Interference may occur when used on patients with cardiac pacemakers. This system emits electromagnetic
fields, which means there are some potential risks. The malfunctioning of implantable devices such as cardiac pacemakers and
ICDs (implantable cardioverter defibrillator) is possible. Ask patients and users if they have an implanted device before using
this product. Explain the circumstances to them. Weight the risks and benefits and contact your patient's cardiologist or
appropriate qualified healthcare professional prior to performing the treatment Keep this product away from implanted
devices Make appropriate emergency provisions and take immediate action if patients become ill. Symptom including a raised
heartbeat, irregular pulse, and dizziness may signal problems with a cardiac pacemaker or ICD.
2.3 Responsibility of the manufacturer
The ATS Dental can only accept responsibility for the safety, reliability, and performance of the B‐ONE when there is compliance with
the following directions:
•
The B‐ONE must be used in accordance with these Instructions for Use.
•
The B‐ONE has no components which can be repaired by the user.
Assembly, modifications, or repairs must only be undertaken by an authorized service organization.
•
Unauthorized opening of the equipment invalidates all claims under warranty and any other claims.
•
Use on electrical circuit complying with the terms of regulation CEI 64‐8 section 710.
•
Use of components which are not original or different from those specified in the paragraph PACKAGE CONTENTS.
2.4 Disposal of the equipment
Please observe the regulations applicable in your country.
Within the European Economic Community, Council Directive 2002/96/EU (WEEE) requires environmentally sound recycling/disposal of
electrical and electronic devices. Your product is marked with the adjacent symbol. Disposal of your product with domestic refuse is not
compatible with the objectives of environmentally sound recycling/disposal. The black bar underneath the "garbage can" symbol means
that it was put into circulation after Aug. 13, 2005. (See EN 50419:2005) Please note that this product is subject to Council Directive
2002/96/EU(WEEE) and the applicable national law of your country and must be recycled or disposed of in an environmentally sound
manner. Please contact your dealer if final disposal of your product is required.
NOTICE:
It is necessary for the user to report to the manufacturer and the competent authority of his state any serious accident that occurs in
relation to the device.
USER MANUAL Rev 25/05/2023
ATS DENTAL srl – 51034 Serravalle Pistoiese – Italy – www.atsdental.it – [email protected]
B‐ONE
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