Chapitre 15 : Annexe
15.4 Instructions concernant l'utilisation des « logiciels »
Contents
A.
Peritoneal dialysis device – "Free software"
B.
Note required according to German Medical Devices Act
C.
Information and remarks on the free software contained in the sleep•safe harmony
A. Peritoneal dialysis device – "Free software"
In addition to other software, the peritoneal dialysis device contains what is called "free software" which is subject to license conditions deviating from those of the
proprietary software protected for Fresenius Medical Care and their licensors.
Some of the license conditions pertaining to such free software provide that Fresenius Medical Care is authorized to distribute the peritoneal dialysis device only if
the accompanying documentation contains special information and notes, supplies license conditions and/or provides the source code of such free software.
Fresenius Medical Care meets these requirements by providing the copyright notices, remarks and license texts contained in Section C. below. Please note that, if
such information is printed in two languages, the English version has priority.
However, the privileges 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 peritoneal dialysis device and subsequently continue use of the device with these modifications. On the contrary, the German
Medical Devices Act prohibits any further operation of the peritoneal dialysis device once the software contained therein has been modified, because any medical
device may only be operated in the form certified. For this 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 extinction of warranty claims against Fresenius
Medical Care or other vendors of the peritoneal dialysis device in the event a claim has arisen or might arise in respect thereto. Any utilization of the free software
contained in the peritoneal dialysis device in a manner other than that required during proper operation of the system will be solely 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 peritoneal dialysis device
is protected by copyright for the benefit of Fresenius and their licensors and may be used only as intended for the peritoneal dialysis device.
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 German Medical Devices Act
This medical device has been certified together with the Wind River Linux 9 operating system software. 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 the German Medical Devices Act 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 is liable to
be prosecuted. According to Section 41 MPG (Medizinproduktegesetz, German Medical Devices Act), he or she may be sentenced to up to one year of 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 peritoneal dialysis device
alsa-lib:
LGPLv2.1 & GPLv2
Copyright (c) 2003 by Abramo Bagnara <abramo@alsa-project.org>
alsa-utils
GPLv2
base-files
GPLv2
base-passwd
GPLv2
bash
GPLv2
busybox
GPLv2 & bzip2
Copyright (C) 1996-2010 Julian R Seward (libbzip2)
bzip2
bzip2
Copyright (C) 1996-2010 Julian R Seward
ca-certificates
GPLv2
2003 Fumitoshi UKAI <ukai@debian.or.jp>
2009 Philipp Kern <pkern@debian.org>
2011 Michael Shuler <michael@pbandjelly.org>
cairo
LGPLv2.1
canutils
GPLv2
coreutils
GPLv2
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Fresenius Medical Care sleep•safe harmony IFU-FR 13D-2023