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NOTES
This document is provided as a consultation manual intended for the device users.
CEFLA s.c. follows a policy based on the constant development and update of the product. For this reason, it
reserves the right to change the content of this manual without prior notice.
This 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
CEFLA s.c.
The original version of this manual is in Italian.
NEWTOM™ 5G is a trademark of CEFLA s.c.
All other products and trade names mentioned in this document are registered marks of the relevant
manufacturers.
INFORMATIVE 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). Such 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. 626 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. 46 implementing Directive 93/42/EEC as amended, on the medical
devices.
The 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.
Any tampering with, modification, updating or other change both of hardware 1 and software 2 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. This may also alter the safety features with
consequent hazard increase for patients, operators and surrounding environment.
For this reason, should the user need to modify the device, he/she must request a written authorisation by
CEFLA s.c.
Failure 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.
Automatic 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.g.
file and printer sharing service) and/or applications represent an important modification.