Tecnomed Italia Skudo, Инструкция по установке, эксплуатации и обслуживанию

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or use of the device and its accessories and/or from improper and/or lack of cleaning and/
or maintenance.
5.2 - STANDARDS/CERTIFICATIONS
Medical device
The SKUDO™ device bears the CE mark.
The SKUDO™ device is classifi ed as a class I medical device according to rule 1 of annex
IX of Directive 93/42/EEC.
The device also complies with the following standards:
Number Title
EN ISO 14971:2012 Medical devices – Application of risk management
Dir.93/42/EEC European directive concerning medical devices
Legislative Decree46/97 Implementing directive 93/42
Dir.2007/47/EC
Updating directive 93/42
Legislative Decree37/10 Implementing directive 2007/47
EN 1041:2010
Information supplied by the manufacturer with the Medical
Devices
ISO 15223-1:2012
Medical devices -Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1:General
requirements
EN ISO 13485:2012 Medical devices. Quality management systems
EN 62366:2007 Application of Usability engineering to Medical Devices
5.3 - TECHNICAL FEATURES
Product code: DP2003S
Head diameter:300 mm
Flexible arm length:900 mm
Swivel angle:180°
Min/Max Operating air pressure:4-4.5 bar
Air consumption at 4 bar:16 l/min
Minimum suction depression:180 mbar
Additional noise at suction:12 db
Air blade size:H 210 x L 150 mm
Collar buttonhole size:90 x 10.5 mm
Weight:2 kg
Head material:White Plexiglas / anodised aluminium
Suction tube connection:Universal connector for large or small cannula
Power supply: pneumatic (with tube and quick coupling supplied)
93/42 EEC certifi cation, Class I
WARNING! If there is no 4 bar, it is essential to insert a pressure regulator upstream of
the unit.The regulator must be connected to the pneumatic system of the dental unit and
calibrated at 4 bar.
Packing dimensions:
• BOX 1
Dimensions 400x400x100 mm
(width x depth x height).Weight 2 kg (approx).