Envitec 45-00-0501, Руководство пользователя

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2 Safety Instructions and Use
•
The product PhysioQuant carries the CE mark CE-0123 in accordance
with European Council Directive 93/42/EEC in relation to medical devices
and complies with the fundamental requirements stated in Appendix I of
this Directive. The device has an internal power source and comes within
Class IIa (MDD).
•
The device has an application part of the type 'BF'.
•
Standard EN 60601-1 'Medical electrical equipment, Part 1: General
Requirements for Safety' is complied with, as well as the immunity
requirements of standard EN 60601-1-2 'Electromagnetic Compatibility -
Medical Electrical Equipment'.
•
The device is interference-free in accordance with EN 55011 - Class B.
•
The CE mark only includes those components described in the delivery
overview.
•
This manual forms part of the device. It should always be kept near to the
device. Correctly observing the manual ensures that the device will be
used in an appropriate manner and for the purpose it is intended. It will
also ensure the health and safety of users and patients dependent on it.
• Please read through the whole manual carefully, since information that is
relevant to several sections is only provided once.
•
The printed text of this manual is in accordance with the version of the
device, as well as the relevant safety instructions standards, at the time
that this manual was printed. All industrial property rights are reserved in
relation to any devices, circuits, processes, software programs and names
described in this manual.
•
The quality assurance system used by EnviteC-Wismar GmbH in all the
company facilities complies with standards EN ISO 9001 and EN ISO
13485.
•
In order to ensure the highest level of safety for patients and a minimum of
interference, as well as keeping in line with the relevant testing precision
level, the device should only be used in combination with original
accessories provided by EnviteC-Wismar GmbH.
•
No warranty claims can be made in the event of any damage as a result of
using other inappropriate accessories and consumable materials.