Operator's Responsibility For Patient Safety; Limitation Of Liability - Dräger Medical Narkomed 6400 Operator's Instruction Manual

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Introduction

Operator's Responsibility for Patient Safety

Draeger Medical anesthesia products are designed to provide the greatest
degree of patient safety that is practically and technologically feasible. The
design of the equipment, the accompanying literature, and the labeling on
the equipment take into consideration that the purchase and use of the
equipment are restricted to trained professionals, and that certain
inherent characteristics of the equipment are known to the trained
operator. Instructions, warnings, and caution statements are limited,
therefore, to the specifics of the Draeger Medical design. This publication
excludes references to hazards that are obvious to a medical professional,
to the consequences of product misuse, and to potentially adverse effects in
patients with abnormal conditions. Product modification or misuse can be
dangerous. Draeger Medical disclaims all liability for the consequences of
product alterations or modifications, as well as for the consequences that
might result from the combination of Draeger Medical products with
products supplied by other manufacturers if such a combination is not
endorsed by Draeger Medical.
The operator of the anesthesia system must recognize that the means of
monitoring and discovering hazardous conditions are specific to the
composition of the system and the various components of the system. It is
the operator, and not the various manufacturers or suppliers of
components, who has control over the final composition and arrangement
of the anesthesia system used in the clinical practice. Therefore, the
responsibility for choosing the appropriate safety monitoring devices rests
with the operator and user of the equipment.
Patient safety may be achieved through a variety of different means
depending on the institutional procedures, the preference of the operator,
and the application of the system. These means range from electronic
surveillance of equipment performance and patient condition to simple,
direct contact between operator and patient (direct observation of clinical
signs). The responsibility for the selection of the best level of patient
monitoring belongs solely to the equipment operator. To this extent, the
manufacturer, Draeger Medical, disclaims responsibility for the adequacy
of the monitoring package selected for use with the anesthesia system.
However, Draeger Medical is available for consultation to discuss
monitoring options for different applications.

Limitation of Liability

Draeger Medical's liability, whether arising from or related to the
manufacture and sale of the products, their installation, demonstration,
sales representation, use, performance, or otherwise, including any
liability based upon Draeger Medical's product warranty, is subject to and
limited to the exclusive terms of Draeger Medical's limited warranty,
whether based upon breach of warranty or any other cause of action
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Air-Only Mode Operator's Manual Part Number: 4118081-001 Rev: A