Notice
The Regulatory Information and Technical Specifications User Guide for CS 8100 3D Family includes information on the safety instructions, regulatory information and the technical specifications of the devices. We recommend that you thoroughly familiarize yourself with this guide to make the most effective use of your system.
The CS 8100 3D Family comprises:
- CS 8100 3D: panoramic modality and dental volumetric reconstruction modality (3D focused teeth acquisition and 3D full upper and lower jaw acquisition)
- CS 8100 3D Access: panoramic modality and dental volumetric reconstruction modality (limited to 3D focused teeth acquisition). The system has the capability to expand the field of view to the 3D full upper and lower jaw acquisition with a license upgrade.
- CS 8100 3D Select: Panoramic modality and dental volumetric reconstruction modality, limited to 3D Single (lower or upper) jaw acquisition. The system has the capability to expand the field of view to the 3D full jaw acquisition with a license upgrade.
- CS 8100SC 3D: panoramic modality, dental volumetric reconstruction modality (3D focused teeth acquisition and 3D full upper and lower jaw acquisition) and cephalometric modality
- CS 8100SC 3D Access: panoramic modality, dental volumetric reconstruction modality (limited to 3D focused teeth application) and cephalometric modality (without the 26x24 Field of View (FoV)). The system has the capability to expand the field of view to the 3D full upper and lower jaw acquisition and to the cephalometric 26x24 FoV with a licence upgrade.
- CS 8100SC 3D Select: Panoramic modality, dental volumetric reconstruction modality, limited to 3D Single (lower or upper) jaw acquisition, and cephalometric modality (without the 26x24 Field of View (FoV)). The system has the capability to expand the field of view to the 3D full jaw acquisition and to the cephalometric 26x24 FoV with a license upgrade.
The CS 8100 3D, CS 8100 3D Access and CS 8100 3D Select can be upgraded to Cephalometric modality, when the Scan Ceph module is provided as an upgrade kit.
This document refers to all models as CS 8100 3D Family unless otherwise specified.
The information contained in this guide may be subject to modification without notice, justification or notification to the persons concerned.
No part of this guide may be reproduced without the express permission of Carestream Dental LLC.
U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
This document is originally written in English.
Manual Name: CS 8100 3D Family Safety, Regulatory and Technical Specifications User Guide
Part Number: SM844
Revision Number: 15
Print date: 2022-03
The CS 8100 3D Family complies with Medical Device Directive 93/42/EEC until September 14th, 2022. After this date, the products will be certified according to Medical Device Regulation (EU) 2017/745 and UK Medical Devices Regulations 2002 (SI 618) as subsequently amended by the EU Exit Regulations of 2019 (SI 791) and 2020 (SI 1478).
