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Hanaulux blue 75 / 120 are surgical luminaires used in the patient area and intended to illuminate locally the body of the patient. They are installed as a system of one, two or three luminaires and are intended to support the treatment and diagnosis. They are intended to be used in operating rooms and not for direct contact with patient.

Hanaulux blue 75 / 120 is an Examination and Surgical Light with two lighthead combinations of blue 75 and blue 120. The Hanaulux® blue 75 / 120 is principally the same as the Hanaulux(") blue 30 / 80 in design, material and function. They are intended for illumination purpose and are not intended for therapeutic use and direct contact with the patient.

All used plastics are molded of UL Recognized Component material.

All internal wiring is either Listed fixture wire or Recognized Component appliance wiring material.

The maximum of UV Irradiance is lower then 6 W / m² .

Hanaulux® blue 80 Hospital is intended to be installed in accordance with the National Electrical Code. The system is intended to be connected to a remote, listed, isolating type, 24V transformer.

This document describes the premarket notification (510(k)) for the Heraeus Hanaulux blue 75 and Hanaulux blue 120 surgical and examination luminaires. This submission focuses on the substantial equivalence of these devices to previously marketed devices and compliance with safety standards rather than clinical performance studies. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted or inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are primarily related to safety standards and functional equivalence to predicate devices, rather than specific performance metrics in a clinical context.

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Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.

This document describes a medical device, the HANAULUX blue 80 Hospital, which is an examination and surgical stand light. It does not describe an AI/ML powered device or a study involving such a device.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria and reported device performance related to a study. The document confirms compliance with safety standards (UL 2601, IEC 601-1, UL 153) and states a maximum UV irradiance (

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