Page 5 / 38
Legal and regulatory perspective
The intended use of each Dräger anesthesia device is described in the relevant instructions for use.
Although the wording of the intended use may vary among the devices, the content is very similar: The
devices are specified for use during surgical or diagnostic interventions under the constant supervision
of the user(s).
Any use of the device outside of the intended use specified in the instructions for use (e.g. long-
term ventilation) constitutes off-label use.
If a device is used off-label, the user recognizes that it is not the intended use of the device and does so
at their own responsibility and at his own (liability) risk. However, in a situation in which a patient requires
long-term mechanical ventilation but cannot be ventilated due to a lack of intensive care ventilators, the
benefit of being able to ventilate such a patient with a Dräger anesthesia device has to be weighed
against the risk of the off-label usage of a Dräger anesthesia device. This risk benefit assessment and
the resulting decision have to be made by the responsible health care professional, based on the
circumstances of the particular case.
WARNING: The following information on the legal and regulatory perspective is limited to the
laws in force in the European Union (EU) as of the date of this letter and provides only general
guidance. Please contact your legal counsel for guidance on your particular case.
Summary of Contents for Perseus A500
Page 34: ...Page 34 38 6 1 Decision tree ...
Page 37: ...Page 37 38 10 1 Decision tree ...
