Indications For Use; User Manual Warnings And Cautions - Codonics Horizon SF Bedienungsanleitung

Manufacturer: Codonics Inc.
17991 Englewood Drive
Codonics electronic products and accessories bearing the following symbol are subject to European
Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, amended by Directive
2003/108/EC. The EN 50419 symbol indicates separate collection and return required.
EN 50419 symbol

Indications for Use

CAUTION Approved FDA Class 2 device - Federal law restricts this device to be sold for use by or on
the order of a physician.
The intended use of the Horizon Series Imagers is high-resolution hardcopy imaging of digital
image source material and through the conversion of electronic signals from a wide variety of
direct/indirect medical imaging modality outputs. The hardcopy output includes, however is not
limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR, and Radiation Therapy
planning. Images are suitable for medical image diagnosis use and referral. The system is intended
for use by medical radiologists, imaging modality specialists, and communications to referring
physicians.
The Horizon Series Imagers are dry, thermal, grayscale (G, GS,GSs,GS-Rad, G1, and G2 models) and
grayscale/color (Ci, Ci-s, CiRAD, and SF models) direct thermal printer/imagers.
The Horizon XL is a special model adding 14 x 36in. and 14 x 51in. true size "long" media that
permits digital direct orthopedic application hardcopy, including diagnosis and analysis of scoliosis,
weight bearing spine/hip/knee, and long bone/hip prosthetic and orthopedic appliances work-up
and surgical planning. Horizon XL is applicable to true-size hardcopy of whole body CT, MRI, and
Angiographic and Venous flow imaging procedures.
Horizon Imagers are 510(k) cleared to market as FDA Class 2 devices, Regulation number 892.2040,
Classification Product Code LMC: Horizon Series Medical Multimedia Dry Imagers K021054 and
Horizon XL Medical Long Film Imager Hardcopy Multimedia K060440.

User Manual Warnings and Cautions

CAUTION Approved FDA Class 2 device - Federal law restricts this device to be sold for use by or on the
order of a physician.
Middleburg Heights, OH 44130 USA
Phone: +1.440.243.1198
Fax: +1.440.243.1334
E-mail: WEEE@codonics.com
www.codonics.com