QR srl

Cone Beam Imaging Systems

NewTom 5G User Manual Rev 2.2 July 2016

User Manual

107 Pages

0051  NewTom 5G – User Manual  97050196 Rev... 01... 16  EN   NOTES This document is provided as a consultation manual intended for the device users... R s... l... ollows a policy based on the constant development and update of the product... or this reason, it reserves the right to change the content of this manual without prior notice... his document can not be modified, copied, reproduced, distributed, saved on magnetic or optical supports, or published on websites and other on-line services, in full or in part, without the prior written authorisation of QR s... l... he original version of this manual is in Italian... EWTOM™ 5G is a trademark of QR s... l... ll other products and trade names mentioned in this document are registered marks of the relevant manufacturers... NFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES The medical device referred to in this manual consists of a scanner and a control, display and calculation unit (Main Workstation)... uch device, as delivered and configured by the production and assistance technical personnel, is an X-ray device compliant with the safety requirements set forth by the Italian Legislative Decree of 19 September 1994, no... 26 implementing Directives 89/391/EEC, 89/654/EEC, 89/655/EEC, 89/656/EEC, 90/269/EEC, 90/270/EEC, 90/394/EEC and 90/679/EEC concerning the improvement of the health and safety of workers in the workplace, and with the essential requirements set forth by the Italian Legislative Decree 24 February 1997, no... 6 implementing Directive 93/42/EEC as amended, on the medical devices... he medical device referred to in this manual is an X-ray device compliant with Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment... ny tampering with, modification, updating or other change both of hardware 1 and software2 of the device as supplied and installed by the company (and in the conditions specified in the attached documentation) may partially or totally compromise the device expected operation... his may also alter the safety features with consequent hazard increase for patients, operators and surrounding environment... or this reason, should the user need to modify the device, he/she must request a written authorisation by QR s... l... ailure to comply with what is specified in this informative note will null and void the device warranty and the civil and/or penal responsibility for any consequent damage and/or accident and/or worsening of the patient, operator or other people health (including the surrounding environment) will be borne by the person who tampered with the device or his/her legal representative... 1 Adding of a new memory expansion, a new hardware on the connection bus, a printer, the replacement of the graphic display interface represents an important modification... 2 Including the operative system and the applications already installed upon medical device delivery... utomatic updates of the operative system, changes to network connection parameters, modification and/or addition and/or removal of interface software with hardware (device driver) and/or services (e...  file and printer sharing service) and/or applications represent an important modification...
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