User's Manual

KODAK 1500 Intraoral Camera Safety and Regulatory Guide (8G8224) 1
Safety and Regulatory
Information
Indications for Use
The KODAK 1500 intraoral camera is designed for use by health
professionals in viewing and capturing intraoral or extraoral color images
for the purpose of:
• Enabling practitioners to view and magnify all regions of the oral
cavity to assess overall dental health.
• Assisting communications with the patient by providing a view of
treatment areas before and after a procedure.
• Providing images for documentation in patient records.
There are two configurations for the camera: wired and wireless. The
wired camera is composed of a camera, a docking station, and
accessories. The wireless camera is composed of an additional charge
station and accessories.
Regulatory Information
The KODAK 1500 intraoral camera complies with the following
standards:
• 93/42/EEC European directive for medical devices including
EN 60601-1-2 and collaterals
• Electrical Safety and Electromagnetic Compatibility standards
(IEC) (CEM)
• Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions