Note Required According To Medical Device Legislation; Information And Remarks On The Free Software Contained In The Haemodialysis System; Gnu General Public License, Version - Fresenius Medical Care multiFiltrate Instructions For Use Manual

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Chapter 15: Appendix

However, the rights granted by copyright according to section C and the license texts contained therein, which relate

to such free software, do not include the right to make modifications to the hemodialysis system and subsequently

continue use of the system with these modifications. On the contrary, Medical Device Legislation prohibits any

further operation of the haemodialysis system once the software contained therein has been modified, because any

medical device may only be operated in the form certified. For that reason, section B contains an appropriate note.

In such a case, Fresenius Medical Care will stop any further technical support for the device involved. In addition,

such modifications and / or manipulations may result in the voiding of warranty claims against Fresenius Medical

Care or other vendors of the haemodialysis system if a claim has arisen or might arise in respect thereto. Any use

of the free software contained in the haemodialysis system in a manner other than that required during proper

operation of the device will solely be at your own risk.

Please also note that the powers listed in section C apply only to the "free software" mentioned therein. Any other

software contained in the haemodialysis system is protected by copyright for the benefit of Fresenius and their

licensors and may be used only as intended for the hemodialysis system.

Both the GNU General Public License (GPL) and the GNU Lesser General Public License (LGPL) are supplied with

this device. You can also download these license conditions from the Internet.

For GPL, please refer to: http://www.gnu.org/copyleft/gpl.html

For LGPL, please refer to: http://www.gnu.org/copyleft/lesser.html

B. Note required according to Medical Device Legislation

This medical device has been certified in conjunction with the Linux operating system software, version 2.4.18. Any

modification to the software contained in this medical device, including the operating system software, may result

in the medical device losing its conformity with the regulations of Medical Device Legislation and in losing its right

to bear the CE mark. Anyone operating a medical device without a valid CE mark according to the Medical Device

Directive 93/42/EEC will be liable to prosecution. According to section 41 MPG (German Medical Products

Directive), perpetrators may be sentenced to up to one year's imprisonment or may be fined. In addition, anyone

modifying the software contained in this medical device or allowing such a modification will also be subject to

product liability against third parties who might be injured.

C. Information and remarks on the free software contained in the haemodialysis system

I. GNU General Public License, version 2

1. Copyright notice

The following copyright notice applies to the Linux operating system (Linux version 2.4.18), including the driver

(DMFE.o) modified therein:

(Linux Version 2.4.18)

This program is free software; you can redistribute it and/or modify it under the terms of the GNU General Public

License as published by the Free Software Foundation, Version 2.

This program is distributed in the hope that it will be useful but WITHOUT ANY WARRANTY; without even the

implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the GNU General

Public License for more details.

Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015

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