500 ECO
Manual_500 ECO_SN0001-following_0520
www.ufsk-osys.com
User and Service Manual
Page 7 of 50
1.4. Declaration of Conformity
Medical devices made by UFSK-International OSYS GmbH bear the CE Mark of Conformity and satisfy the relevant
requirements in terms of safety and functionality. To this end medical devices by UFSK are tested in accordance
with the international standards relevant for medical devices.
The treatment chair
500 ECO
is a Class I medical device and corresponds to the DIN EN 60601-1 and DIN EN
60601-1-2 standards. The equipment features double protective insulation in accordance with Protection Class II
and meets the requirements for a Type B application part.
Please consult Appendix at the end of this instruction and service manual for the complete text of the EC
Declaration of Conformity.
1.5. Definitions of Terms and Signal Words
1.5.1 Definitions of Terms
This paragraph defines groups of persons coming into direct or indirect contact with this product.
Operator
An operator is any person operating the treatment chair, either personally or via authorized persons, in a medical
environment.
User
A user is any person authorized by virtue of his or her professional training, experience or instruction to operate
the treatment chair or to use it for conducting patient examinations and/or administering patient treatments. The
user has been instructed in the handling of the treatment chair. The user is capable of identifying and avoiding
potential hazards.
Patient
A person requiring treatment and in need of appropriate medical care. Appropriate medical care latter shall be
deemed to include the surgeon‘s optimized work sphere featuring an adjustable work chair for proper positioning
of the surgeon’s body and hands as well as any necessary equipment control elements.
Qualified technicians
Qualified technicians are persons who, by virtue of their professional training and/or instruction, are in possession
of the know-how and experience necessary for the delivery, assembly, disassembly, and transportation of the
treatment chair. These persons have been additionally instructed in the cleaning and disinfection regulations
pertinent to this medical device.
1.5.2 Explanations on the signal words used herein
Danger
The signal word ”Danger“ warns against direct danger to persons which will result in death or severe injuries.
Warning
The signal word „Warning“ warns against potential danger to persons which may result in death or severe
injuries.
Caution
The signal word “Caution“ warns against potential danger to persons which may result in moderate or
minor injuries.
Attention
The signal word “Attention“ warns against potential property damage
.
