2 Definitions
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201000401000 / Rev 04
2.3.4 Biocompatibility
The system components described in these instructions for use, including accessories, that come
into contact with the patient during the intended use, meet the biocompatibility requirements of
the applicable standards. If you have questions in this matter, please contact ergoline or one of
their representatives.
2.4 Responsibility of the Manufacturer
The manufacturer is responsible for the results with respect to safety, reliability and performance
only if the following conditions are met:
• Assembly operations, extensions, readjustments, modifications or repairs are carried out by per-
sons authorized by ergoline.
• The electrical installation of the relevant room complies with the requirements of the applica-
ble standards.
• The system is used in accordance with the operator's manual.
• Information is obtained from ergoline before any devices not recommended in this manual are
connected to the equipment.
NOTICE This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This device generates, uses and can radi-
ate radiofrequency energy and, if not installed and used in accordance with the instructions, may
cause harmful interference to radio communications. However, there is no guarantee that inter-
ference will not occur in a particular installation. If this device causes harmful interference to
radio or television reception, which can be determined by turning the device off and on, the user
is encouraged to try to correct the interference by one or more of the following measures
• Reorienting or relocating the receiving antenna.
• Increase the distance between the device and the receiver.
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