(70 days)
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.
| Acceptance Criteria (from "Compliance with Standards") | Reported Device Performance |
|---|---|
| UL 2601 Safety of Medical Electrical Equipment | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| IEC 601-1 Safety of Medical Electrical Equipment | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| IEC 601-2-41 Safety of Surgical Luminaires and Luminaires for Diagnosis | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| UL 153 Portable Electric Lamps | Substantially equivalent to existing surgical lighting program HANAULUX "City" series, HANAULUX 2000 and HANAULUX blue 30 / 80. |
| Maximum UV Irradiance |
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.