HARMONY VLED SURGICAL LIGHTING SYSTEM
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HARMONY VLED SURGICAL LIGHTING SYSTEM - 1

HARMONY® vLED SURGICAL LIGHTING SYSTEM APPLICATION The Harmony vLED Surgical Lighting System is designed to illuminate operating room surgical fields. The system can be adjusted for light intensity in a fixed or variable pattern size. The system is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities. The ceiling mounting plate is compatible with most existing installations. DESCRIPTION The Harmony vLED Surgical Lighting System is a configurable, modular lighting system, providing high quality illumination for surgical and diagnostic applications. The system can be configured to meet the needs of a wide variety of applications ranging from simple diagnostic procedures performed in outpatient surgery centers, to more complicated procedures performed in major acute care suites. Locations of use include operating rooms, exam and treatment rooms, hospital emergency departments and hospital intensive care units. A wall-mounted panel provides a user interface for controlling lightheads and camera. The wallmounted panel monitors LED module status and can be used to control light intensity, as well as camera features such as focus, camera rotation and zoom. In addition, the lightheads can be turned on and off, and their intensity can be controlled using conveniently located surgeon's controls on the lighthandle of each lighthead. The patented surgeon in-light controls include a one-touch command to turn all lightheads on simultaneously to their previous settings. Lightheads provide cool, shadow controlled lighting. The system can be ordered with one, two or threelightheads mounted to a suspension system capable of continuous 360° rotational positioning. The lightheads are available in both adjustable and fixed pattern models. The illumination pattern size is adjusted by rotating the handle. Most Harmony vLED Surgical Lighting Systems can be configured (at time of order) to include one or two video monitor support arms. (Typical – details may vary.) STANDARDS All components of the lighting system meet the applicable requirements of the following standards and/or regulations and carry the appropriate symbols: • International Standard: IEC 60601-1: Medical Electrical Equipment. Part 1: General requirements for safety. Second Edition, 1988. • UL Standard 60601-1, First Edition. Medical Electrical Equipment – Part 1: General Requirements for Safety, 2006. • CSA 22.2 No. 601.1-M90, standard for Electro-Medical Equipment, 1999. • International Standard: IEC 60601-2-41, First edition, 200002: Medical Electrical Equipment, Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis. • EMI/EMC Testing: EN 60601-1-2: 2001: Medical Electrical Equipment-Electromagnetic Compatibility Requirements and Tests. • IE 60878: Graphic Symbols for Electrical Equipment in Medical Devices. • EN1041: 2009.03.27 Information Supplied by the Manufacturer with Medical Devices. • CE Mark to Directive 93/42/EEC (Medical Device Directive). • AAMI 11607: 2006.01.01, Packaging for Terminally Sterilized Medical Devices (Notified Body–ITS/ETL SEMKO 0413). Item _________________ Location(s) ____________ _____________________ _____________________ SD925 (10/01/12)

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HARMONY VLED SURGICAL LIGHTING SYSTEM - 2

FEATURES CONSTRUCTION Lightheads are either adjustable pattern or fixed pattern models. The system’s lighthead uses a dual-lens configuration for adjustable-pattern and a single-lens design for fixed-pattern lightheads. Lightheads are constructed of lightweight, durable materials. Both lighthead models provide naturally appearing white light with a color rendering index of 96, and a color temperature of 4400 Kelvin. The lightheads dissipate heat away from the surgical field for patient safety and surgical team comfort. The optical system consists of multiple Light Emitting Diode (LED) light...

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HARMONY VLED SURGICAL LIGHTING SYSTEM - 3

The FPM is a flexible system of mechanical interconnections enabling users to define the system configuration, allowing the system to accommodate different styles of power inputs and signal inputs within a facility or even within a given room. All electrical and signal configurations are determined by the Customer and installed by third-party providers. camera features: zoom, focus and brightness. The video signal from the camera is available at the canopy controls in either Svideo or composite video format. The camera module provides state-of-the-art video capability using single-chip CCD...

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HARMONY VLED SURGICAL LIGHTING SYSTEM - 4

INSTALLATION SUPPORT STRUCTURE A single or tandem mounting plate is provided for installation to an above-ceiling support structure (support structure is not supplied by STERIS). See equipment drawings for specifications and details. A canopy is also furnished to conceal the ceiling plate; a flexible gasket seals the gap between the canopy and ceiling. The ceiling structure (installed by a third party prior to lighting system installation) must be level and must adequately support the surgical light system configuration to be installed. Data provided on the equipment drawing (available...

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HARMONY VLED SURGICAL LIGHTING SYSTEM - 5

UTILITY REQUIREMENTS THREE LIGHTHEAD SYSTEM CANOPY CONTROLS ENVIRONMENTAL REQUIREMENTS (System Running) CUSTOMER IS RESPONSIBLE FOR COMPLIANCE WITH APPLICABLE LOCAL AND NATIONAL CODES AND REGULATIONS. For sealed ceiling applications: Electricity – Canopy-mounted controls are compatible with the following ratings: • 100 - 240 Vac, 5 - 2 A maximum for a three-lighthead system. • For optional Battery Backup: 21 - 29 Vdc, 10A (nominal). • Earth current leakage is limited to less than 3mA. • 60°C (140°F) Maximum 100 - 240 Vac, 50/60Hz. • Canopy Ambient Ceiling plate desired mounting height is at...

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HARMONY VLED SURGICAL LIGHTING SYSTEM - 6

Drawing not to scale, dimensions shown are typical 2240 mm (88-1/4") 2286 mm (90") Ceiling Structure 850 mm (33-1/2") 1000 mm (39-3/8") 700 mm (27-1/2") Ceiling Plate (Provided by STERIS) Mounting Studs (Not Provided by STERIS) on ti lla ta s In or F Finished Ceiling Canopy Secondary Canopy Single Flat Panel Monitor Mount (Monitor Not Provided by STERIS) 1475 mm (58") Lighthead #2 See Minimum Ceiling Height Recommendations Below t o N Camera Module (CameraReady Systems Only) Lighthead #1 (With or Without Video) Dual Flat Panel Monitor Mount (Monitors and Wiring Not Provided by STERIS)...

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