ATS Dental BNE300 Руководство по эксплуатации и техническому обслуживанию - Страница 2
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Read this instruction booklet carefully before installing and using the machine. In this way, you will obtain the best possible results
and maximum operating safety. This booklet must be kept with the apparatus in case of sale or transfer to another user.
DM Classification Reg 2017/745UEC (AnnexVIII) CLASSIIa rule 9.
Classification CEI EN 60601
Class I Equipment
Type BF Applied Part
Ordinary Equipment ‐ degree of protection against ingress of water
Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
2.1 Purpose – Proper use:
B‐ONE is intended only for use in the field of dentistry, for surgery to expose and dissect oral tissue structures (such as the periodontal
gap, gingival, bone, the jaw, extractions, and implantations). The product may not be used for a purpose for which it was not intended.
"Proper use" includes following all the instructions for use and ensuring that all inspections and service tasks are performed.
The overarching guidelines and/or national laws, national regulations, and the rules of technology applicable to medical devices for start‐
up and use of the ATS DENTAL product for the intended purpose are to be applied and complied with.
The user must ensure that that the unit works properly and is in a satisfactory condition before each use.
During use, national legal regulations must be observed, in particular:
the applicable health and safety regulations
the applicable accident prevention regulations
Users have a duty to:
Only use equipment that is operating correctly.
To protect himself, the patient and third parties from danger
To avoid contamination from the product
Device users:
Use of the B‐ONE is restricted solely to qualified, trained and competent dental health practitioners in the normal context of
their work.
If you have received this device by error, please contact the supplier so that it can be removed.
USER MANUAL Rev 25/05/2023
2017/745 UE
Follow
Instructions
Type B appliance
Manufacturer
Serial Number
Class I Equipment
Production year
2. NOTICE/WARNING
ATS DENTAL srl – 51034 Serravalle Pistoiese – Italy – www.atsdental.it – [email protected]
B‐ONE
Page 2 of 16
1. SYMBOLS
for
use
V
REF
#
MD
Risk of electric shock
Disposal Information
Supply Voltage
Reference
Model Name
Web user manual
Mode: continuous operation
with intermittent load
MEDICAL DEVICE