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Instructions for use arco-matic 200 M / 300 M - Version 2018-05-08 GBR ID no. 2038823A
Regulatory
Product classifi cation
In combination with the accessories listed in “Tab.
1” on page 8, the product is a Class I medical
device according to Annex IX of the Medical Device
Directive 93/42/EEC. Harmonised standards were
used to assess compliance. The product meets the
fundamental requirements according to Annex I of
Directive 93/42/EEC, as well as of amending Council
Directive 2007/47/EC regarding medical devices
(Medical Device Directive).
Intended use
Only uses that are listed in this “Intended use”
chapter are intended for the purposes of IEC 60601-
1:2005 + amendment: 2006 + amendment: 2007 +
supplement1:2012
.
Any other use will result in an
exclusion of liability.
The examination and treatment chair arco-matic is
intended for use in human medicine only.
The examination and treatment chair may be used
for the following purposes:
•
for the short-term positioning of patients for
urological examinations and treatment of
non-anaesthetised or sedated persons. A person
placed under the care of a guardian may only be
positioned on the examination chairs under super-
vision. Under these same conditions, the exami-
nation chair can also be used in gynaecology and
proctology.
The examination and treatment chair may not be
used:
•
as an operating table,
•
for transporting patients.
The safe working load of the examination and
treatment chair as per IEC 60601-1:2005 + amend-
ment:2006 + amendment:2007 + supplement 1:2012
is 250 kg less the weight of the attached accessories.
It may only be used in Group 0 and Group 1 medical
rooms according to and/or IEC 60364-7-710:2002-11.
Permissible user groups for the product are:
•
Trained medical personnel (doctor/nurse)
•
Trained cleaning staff
•
Hospital technicians