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ALM Prismalix (PRX) Surgical Lights are intended to provide visible illumination for the surgical field or for the examination of the patient. PRX is designed to eliminate shadows, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures. Use.is by surgeons and other medical care givers. The ALM PRX Surgical Lights will be used in indications which are the same as indications for other surgical lights currently offered for commercial distribution in the United States.

The new product known as "Prismalix™" is of similar technology to surgical lights covered under D.C. Number K882613 issued on June 29, 1988. The differences between the new Prismalix™ models and models previously sold are cosmetic along with the addition of a tilting mechanism (in selected models) which allows variations in pattern size. The surgical light consists of single or multiple lightheads attached to suspension arms supported from hospital installed mounting plates. Light heads can be positioned for optimal illumination of the surgical site by grasping sterilizable handles or non-sterile handles on the lighthead. Low voltage power is supplied to the light bulb by way of a remote mounted transformer similar to those used by other surgical lighting manufacturers. Light intensity is controlled by a dimmer system, mounted remotely at a wall location. Illumination is measured in footcandles or lux (1 footcandle equals 10.764 lux). Reference publication RP-29-95 Lighting for Hospitals and Health Care Facilities chapter 4, section 11, page 18. Illuminating Engineering Society of North America. New York, NY 1995. IES recommends a minimum illumination level at the surgical site of 2,500 footcandles when the light is positioned one meter above the site. The Prismalix™ series meets and exceeds this recommendation. The previous range of lighting covered under K882613 is referenced by the three sizes of light heads; 500 mm or 5000 series, 700mm or 7000 series, and 900mm or 9000 series. The Prismalix™ series will be referenced by three sizes of light heads; 400mm or 4000 series, 600mm or 6000 series, and 800mm or 8000 series. It is possible to provide a fixed focus video camera in selected 4000 series light heads. This Prismavision camera is similar in overall design and construction to the current ALM fixed focus camera, and other surgical/endoscopic video cameras offered for commercial distribution in the United States.

Drager Gemina System is a nonpowered piece of durable The equipment intended to provide wall mounted physical support for medical/surgical monitoring and related equipment, storage space, and wall mounted dispensing of medical gases and electrical power required in patient care clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms. The Gemina System will be used in the same indications as other systems which provide overhead or wall mounted physical support and storage of equipment for dispensing of medical gases and electrical power.

The Gemina System is a wall mounted supply system of modular design. The individual components of this modular system are wall fixture, horizontal element, column, support tube, and equipment carrier (shelf). column contains two large terminal plates that can be The outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc.

8080 System is a piece of durable equipment The Drager DVE intended to provide ceiling mounted overhead physical support anaesthesia machines, medical/surgical monitoring and for and ceiling mounted related equipment, storage space, dispensing of medical gases and electrical power required in clinical settings, emergency rooms, intensive care, procedure rooms and operating rooms. 8080 will be used in the same indications as the DVE The DVE 4000 System and the DVE 8000/1/2 System and the Drager 8032E which provide physical support, storage space, and overhead, ceiling mounted dispensing of medical gases and electrical The DVE 4000 has previously been reviewed by FDA power. (K921297). The Drager 8000/1/2 Series System and the combined DVE 8000/1/2 with DVE 4002 have been previously reviewed by FDA (K942043). The new DVE 8080 Series will be used in indications which are the same as indications for the DVE 4000, DVE 8000, for other pendant systems currently offered for DVE 8032E and commercial distribution in the United States.

The DVE 8080 Series System is a ceiling mounted overhead supply system of modular design. The individual components of any modular system are divided into four categories: ceiling fixture, support systems, pendant head or column, and equipment carrier. The pendant column contains four terminal plates that can be outfitted according to the individual need with various outlets for gas supply, electricity, vacuum, communications, etc. Add-on terminal boxes are available. The support system consists of either a fixed vertical support tube (DVE 8080 basic version of the series) or a single (DVE 8081) support arm or two (DVE 8082) support arms. The support arms are equipped with pneumatic brakes and are available in three combinable lengths. The DVE 8080 Series System rotates laterally and is powered for up and down adjustment. The motor used in the DVE 8080 is an induction motor manufactured by Gefeg GmbH & Co KG. An equipment shelf provides for better positioning of the medical devices required and can be installed at time of purchase or added-on afterwards. Shelves are available in one standard size: 620 mm (width) by 400 mm.