Dräger Polaris Multimedia Instructions For Use Manual page 9

Device combinations
This device can be operated in combination with
other Dräger devices or with devices from third-
party manufacturers. Follow the accompanying
documents of the individual devices.
If a device combination is not approved by Dräger,
the safety and the functional integrity of the
individual devices may be compromised. The
operating organization must ensure that the device
combination complies with the applicable editions
of the relevant standards for medical devices.
Device combinations approved by Dräger meet the
requirements of the following standards:
– IEC 60601-1 (2nd Edition)
Medical electrical equipment
Part 1: General requirements for basic safety
– IEC 60601-1-1
Medical electrical equipment
Part 1-1: General requirements for basic safety
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for basic safety
and essential performance
Collateral standard: Electromagnetic
compatibility - requirements and tests
– IEC 60601-1-4
Medical electrical equipment
Part 1-4: General requirements for basic safety
Collateral Standard: Programmable electrical
medical systems
– IEC 60601-1-8
Medical electrical equipment
Part 1-8: General requirements for basic safety
and essential performance
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
Instructions for use Polaris Multimedia
Patient safety
The design of the medical device, the
accompanying documentation, and the labeling on
the medical device are based on the assumption
that the purchase and the use of the medical device
are restricted to persons familiar with the most
important inherent characteristics of the medical
device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
The instructions for use do not contain any
information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
Safety-related information
9