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Summary of Contents for Carestream DENTAL CS 7200
- Page 1 CS 7200 Safety, Regulatory and Technical Specifications...
- Page 2 ©Carestream Dental LLC., 2023. The information in this document is subject to change. Neither Carestream Dental nor any of its subsidiaries shall be liable for errors contained herein or for incidental damages in conjunction with the furnishing, performance, or use of this material.
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Page 3: Table Of Contents
General Regulatory Information ... 15 Regulatory Warnings... . 17 Information CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389)_Ed08... - Page 4 Chapter 3 Model ....25 Technical CS 7200 Technical Specifications ..25 Specifications Power Supply ..26 RF Information .
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Page 5: Indications For Use
Safety Information Indications for Use The CS 7200 is intended for use in dental digital radiography using imaging plates (phosphor storage screens) for dental intraoral X-ray imaging of pediatric and adult patients. Clinical Benefits and Performance Characteristics The CS 7200 benefits healthcare professionals by enabling them to acquire digital intraoral X-ray images of the dento-maxillofacial area. -
Page 6: Warnings And Safety Instructions
Note: Emphasizes important information. Tip: Provides extra information and hints. Warnings and Safety Instructions There are no contraindications identified for the CS 7200. When operating the device, observe the following warnings and safety instructions. IMPORTANT: All known residual risks and undesirable side effects are listed in this guide. -
Page 7: Warnings
Keep this guide with the equipment. You are responsible for the operation and maintenance of this device. You are required to have training to use the CS 7200. When necessary, have a trained, authorized service technician carry out inspection and maintenance operations. - Page 8 DO NOT operate the device if there is the threat of an earthquake. Following an earthquake, ensure that the device is operating satisfactorily before using it again. Failure to observe this precaution may expose patients to hazards. The plug or appliance coupler/inlet of the flexible power cord shall be used as a disconnecting device to isolate the equipment from the mains.
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Page 9: Imaging Plates
Read and follow the instructions in Material Safety Data Sheets (MSDS) for the CS Screen Cleaner. The commercially prepared disinfectant must be used according to manufacturer’s instructions. CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 10: Computer
In order to guarantee the level of current leakage, when connecting the computer to the CR scanner, the system shall comply with the requirements of the IEC 60601-1-1 standard. If in doubt, contact Carestream Dental. DO NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient. -
Page 11: Laser Warnings
Access to the rear inspection cover is allowed, as an exception, according to the instructions for retrieval of the imaging plate in the Troubleshooting section of the user guide. CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 12: Precautions Before Use
Imaging Plate Care If used with care, Carestream Dental imaging plates can be used repeatedly. The imaging plates will show wear over time, due to continuous use. Inspect the imaging plates regularly, and replace them if they are scratched and/or show signs of excessive wear. -
Page 13: Cleaning The Imaging Plate
CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 14: Disposing Of The Imaging Plate
To disinfect the sheaths and imaging plates, follow these steps: Follow the disinfectant manufacturer’s instructions for disinfecting the sheaths and imaging plates. The sheaths and plates should be kept visibly wet for the full contact time specified on the disinfectant label. Note: Do not soak the sheath or imaging plate in the disinfectant solution. -
Page 15: Scanner Care
(A) and lifting out the insertion panel (B). Use disinfectant wipes for medical equipment to clean the detachable insertion panel thoroughly from all sides, including the slot. CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... - Page 16 Install the cleaned and disinfected insertion panel by inserting the location pins into the designated slots in the scanner (A) and pressing the insertion slot panel in (B) until it is completely inserted. 12 Chapter 1 Safety Information...
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Page 17: Marking And Labeling Symbols
Warning, electricity (located on the PM board). Class 3B laser product inside scanner (located on the optical head and scanner back cover). General mandatory action sign. Refer to instruction manual/booklet. Medical Device CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 18: Label Locations
Name of the European authorized representative and address of the registered place of business EC REP Name of the Responsible Person in the United Kingdom and address of the registered place of business Name of the Swiss authorized representative and address of the registered place of business Label Locations The following figures are used only to illustrate the label locations. -
Page 19: General Regulatory
Part 1: Evaluation and testing within a risk management process EN 60825-1 Safety of laser products-Part 1: Equipment classification and requirements EN/IEC 62366-1 Medical devices - Application of usability engineering to medical devices CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... - Page 20 Compliance with European and International Standards CAN/CSA-C22.2 No. Medical Electrical Equipment - Part 1: 60601-1: General requirements for basic safety and essential performance ANSI/AAMI ES60601-1 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance EN 300 330 Short Range Devices (SRD);...
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Page 21: Warnings
(EMC). The CS 7200 must be installed and put into service according to the EMC information provided in this documentation. The CS 7200 may interfere with other equipment, even if that other equipment complies with CISPR emission requirements. Warning: Portable and mobile Radio Frequency (RF) communications equipment can affect the Electromagnetic Compatibility of the CS 7200. - Page 22 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the CS 7200, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
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Page 23: Guidance And Manufacturer's Declarations
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The CS 7200 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7200 should assure that it is used in such an environment. Emissions Test Compliance... - Page 24 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 7200 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7200 should assure that it is used in such an environment. IEC 60601...
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Page 25: Emc Standards Information
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 7200 is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 7200 should assure that it is used in such an environment. Immunity... - Page 26 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity For the immunity to proximity fields from RF wireless communications equipment, the CS 7200 is compliant with the test levels specified below according to IEC60601-1-2 standard. The customer or the user of the CS 7200 should assure that it is used in such an environment.
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Page 27: Compliance With International Regulations
This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... - Page 28 24 Chapter 2 Regulatory Information...
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Page 29: Model
During scanning 50 db (A) CS 7200 Environmental Requirements +15 ~ +35 C Operating temperature Transportation and storage -1060 C temperature Operating relative humidity 30 ~ 85% RH (Non-condensing) CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 30: Power Supply
AC/DC adapter P/N TR30RAM240. Cable Type (or Cable Model Name Cable From Description and Manufacturer Length for This Cable) USB Cable CS 7200 PC USB Shield USB Port Port RF Information RF Information Scan & Go standard ISO15693 Frequency 13.56 MHz... -
Page 31: Imaging Plate Technical Specifications
High Speed (HS) Ultra High Resolution (UHR) *LP/mm: Line pairs per millimeter (measured on grid resolution target, in scan direction) Imaging Plate Dimensions 0 Height (mm) Width (mm) CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08 27... -
Page 32: Minimum Computer System Requirements
Minimum Computer System Requirements If necessary, you must update your computer system configuration. Minimum System Item Comments Requirement For best performance 2 GHz Intel® Dual Core™ it is recommended to use an Intel® Core™ AMD Athlon or higher i7 processor. RAM has a major 2 GB (4 GB recommended) impact on system... -
Page 33: Manufacturer's Address
4, Rue F. Pelloutier Croissy-Beaubourg 77435 Marne-la-Vallée, Cedex 2 France Responsible Person in the United Kingdom Carestream Dental Ltd. Jessica Igies-Mikaelson Wiltron House, Rutherford Close Stevenage Hertfordshire, SG1 2EF United Kingdom CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... -
Page 34: List Of Importers For European Union According To The Mdr 2017/745
Authorized Representative in Brazil Carestream Dental Brasil Eireli Rua Romualdo Davoli, 65 1º Andar, Sala 01 - São José dos Campos São Paulo - Brazil CEP (Zip code): 12238-577 Authorized Representative in Brazil Carestream Dental Brasil Eireli Rua Romualdo Davoli, 65 1º... -
Page 35: List Of Importers For Switzerland
Riedstrasse 12 CH-8953 Dietikon Switzerland Dema dent AG Furtbachstrasse 16 CH-8107 Buchs Switzerland Jordi Röntgentechnik AG Dammstrasse 70 CH-4142 Münchenstein Switzerland E. Schweizer AG Bernerstrasse Nord 182 CH-8064 Zürich Switzerland CS 7200 Safety, Regulatory, and Technical Specifications User Guide (6M1389) _Ed08... - Page 36 For more information, visit: www.carestreamdental.com To give documentation feedback, visit: www.carestreamdental.com/documentationfeedback ©Carestream Dental, LLC, 2023. 2023-08 6M1389 Ed08...
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