PHYSIO-PORT
User Manual Version 2017-11-12
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1.
General Information
1.1
To this manual
The greatest care has been taken in preparing this manual. However, if you still come across any
incorrect details in this manual when using the system, then please contact us. This will allow us to
correct any errors as soon as possible. The information and images contained in this manual are
subject to any changes that may result from optical or technological developments
All trademarks stated and used in the text are the property of the present owner and are protected by
law. All reproduction, translation and duplication in any shape or form – including extracts – require
the written approval of the manufacturer. This manual is subject to updates by PAR Medizintechnik
GmbH & Co. KG
.
1.2
Confirmity
The product PHYSIO-PORT bears the CE marking
CE-0482
(notified body MEDCERT GmbH) indicating
its compliance with the provisions of the Council Directive 93/42/EEC about medical devices (including
amendment 2007/47/EC) and fulfills the essential requirements of Annex I of this directive. It has an
internal power source and is an MDD class IIa device.
1.3
Identifier
The device has an application part of the type 'BF'.
The product fulfills the requirements of the standard EN/IEC 60601-1 "Medical Electrical Equipment,
Part 1: General Requirements for Basic Safety and Essential Performance" as well as the electromagnetic
immunity requirements of the standard EN/IEC 60601-1-2 " Medical electrical equipment – Collateral
standard: Electromagnetic compatibility – Requirements and tests" and applicable amendments.
This symbol
means:
Please consult the manual. It refers to things to which you should pay careful attention when using the
device. This manual is an integral part of the equipment. It should be available to the equipment
operator at all times. Close observance of the information given in the manual is a prerequisite for
proper equipment performance and correct operation and ensures patient and operator safety.
Please
note that information pertinent to several chapters is given only once. Therefore, carefully read the
manual once in its entirety.
