Tecnomed Italia MORPHEUS, Инструкция по установке, эксплуатации и обслуживанию

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ENGLISH
5- PRODUCT DESCRIPTION
5.1 - INTENDED USE AND METHOD OF USE
Morpheus is a multifunctional surgical chair designed for the following sectors: Dentistry,
Maxillofacial surgery, Reconstructive microsurgery, Dermatology, Otolaryngology, Gynae-
cology, Sampling, Diagnostics. This device is not intended for use in potentially explosive
atmospheres.
It is the responsibility of the user to:
1- Use only EC certified devices in perfect state.
2- Protect himself, the patients and any third parties from any hazards.
3- Avoid any contamination of the product.
When using the device, follow the applicable regulations in force in the country of use, especially:
1- The provisions in force regarding safety at work.
2- The accident prevention measures in force.
DANGER! he device must be used exclusively by specialised and suitably trained personnel.
Use the device only for the intended use that is foreseen for it. Failure to observe this prescription
may cause serious injuries to the patient, the operator, and damages to the device.
DANGER! Tecnomed Italia s.r.l. declines any liability, expressed or implied, and cannot
be held liable for personal injury and/or direct or indirect property damage deriving from
failure to comply with the instructions in this manual and/or from incorrect installation and/
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 MORPHEUS surgical chair is fitted with CE marking.
The Morpheus device is classified as class IIa medical device based on rule 1 of annex IX of
Directive 93/42/CEE.
Protection class: Class I (EN 60601-1)
Part applied: type B
The surgical chair is also compliant with the following standards:
Number Title
EN ISO 14971:2012 Medical devices – Application of risk management
EN 60601-1:2006 Third Ed. Medical electrical equipment – General requirements for safety.
EN 60601-1-6:2007
Medical electrical equipment – General requirements usability
Dir. 93/42/CEE European directive concerning medical devices
Law Decree 46/97 Implementing directive 93/42
Dir 2007/47/CE Updating directive 93/42
Law Decree 37/10 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 la-
bels, labelling and information to be supplied - Part 1: General
requirements
EN ISO 13485:2012 Medical devices. Quality management systems
ISO 6875:2011 Dentistry - Dental patient chair
EN 62366:2007 Application of Usability engineering to Medical Devices