Carestream DENTAL CS 1200 Safety & Regulatory Manual
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Summary of Contents for Carestream DENTAL CS 1200
- Page 1 Safety & Regulatory Guide...
- Page 2 The CS 1200 is intended for professional use only. US Federal law restricts this device to sale by or on the order of a dentist. Manual Name: CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide Part Number: 9H1808...
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Page 3: Table Of Contents
Model....19 Technical Technical Specifications ..19 Specifications Minimum Computer System Requirements ...21 CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... - Page 4 Chapter 4 Manufacturer’s Address ..23 Authorized Representatives ..23 Contact Information...
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Page 5: Conventions In This Guide
WARNING: Warns you to avoid injury to yourself or others by following the safety instructions. Important: Alerts you to a condition that might cause problems. Note: Emphasizes important information. Tip: Provides extra information and hints. CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... -
Page 6: Warnings
Warnings and Safety Instructions Warnings Camera • You MUST read and understand this safety information before using the camera. • The camera is not intended to be used with high frequency surgical equipment. • Before using the camera, check the outer surfaces of the camera and any accessories to ensure there are no rough surfaces, sharp edges, or protrusions which may cause a safety hazard. - Page 7 To power off the device, push the power button for 3 seconds. To isolate the device from mains supply, unplug the USB/AV/S-Video cables and the adapter from the power outlet. CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03...
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Page 8: Computer
Computer • DO NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient. Leave at least 1.83 m distance between the patient and the equipment. • The camera is only intended to be connected to the computer or monitor which is at least IEC 60950 or equivalent standards certified. -
Page 9: Hygiene And Disinfection
Hygiene and Disinfection Perform the following maintenance activities on your CS 1200 and accessories regularly. To ensure maximum hygienic safety for the patient, carefully follow the instructions to prepare the CS 1200 for use. To minimize the risk for cross-contamination, after each patient, clean and disinfect the CS 1200. -
Page 10: Cleaning The Camera
Cleaning the Camera If the camera is visibly contaminated with blood and/or body fluids, you must clean the camera before disinfecting it. To clean the camera, follow these steps: Dampen (do not soak) a lint-free cloth with lukewarm water. Remove the blood and/or body fluids with the dampened lint-free cloth. -
Page 11: Visually Inspecting The Camera For Damage
Visually inspect the camera for signs of deterioration, especially around the buttons and the cable. If damage is noted, do not use the camera and contact your representative. CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... - Page 12 Chapter 1 Safety Information...
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Page 13: Marking And Labeling Symbols
Contact your local sales representative for additional information on the collection and recovery programs available for this product. Manufacturer’s address Attention: Consult accompanying documentation. Refer to instruction manual/booklet. Direct current CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... -
Page 14: Label Locations
Label Locations Figure 1 CS 1200 Camera Box Label CS 1200 Intraoral Camera / 数字口腔观察仪 CS 1200 MODEL 655 9991 锐 珂 （ 上 海 ） 医 疗 器 材 有 限 公 司 Made in China by 中 国 （ 上 海 ） 自 由 贸 易 试 验 区... -
Page 15: Indications For Use
Indications for Use The CS 1200 intraoral camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes of: • Allowing practitioners to view regions of the oral cavity. •... -
Page 16: Guidance And Manufacturer's Declarations
Guidance and Manufacturer’s Declarations Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The CS 1200 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or user of the intraoral camera should assure that it is used in such an environment. - Page 17 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 1200 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or the user of the intraoral camera should assure that it is used in such an environment.
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Page 18: Emc Standards Information
Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2: 2007 The CS 1200 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or the user of the intraoral camera should assure that it is used in such an environment. -
Page 19: Recommended Separation Distances
Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the Intraoral Camera System The CS 1200 intraoral camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the... -
Page 20: Emc Standards For Intraoral Camera
EMC Standards for Intraoral Camera IEC 60601-1-2: 2007 EMC requirements and tests, Medical Electrical Equipment including CISPR11:2003 +A1: 2004 + A2:2006 Group 1, Class B. NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. -
Page 21: Compliance With European And International Standards
EN ISO 14971: Medical devices - Application of risk management to medical devices EN 980: Symbols for use in the labeling of medical devices EN 1041: Information supplied by the manufacturer of medical devices CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... -
Page 22: Accessories
Other Equipment The CS 1200 intraoral camera should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the CS 1200 intraoral camera should be observed to verify normal operation in the configuration in which it will be used. -
Page 23: Manufacturer
Video: 640 x 480 pixels Lighting White LEDs 80° Focus range 3 mm - 25 mm Connecting cable length Connection: Computer USB 2.0 high speed Connection: Monitor S-Video; AV CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... - Page 24 (Continued) Components Technical Specifications Output impedance of S-Video and AV 75 ohm cable Dimension 207 x 29x 22 mm Weight of camera without cable 60 g Adapter • Input: 100-240V ~ 50/60Hz, 400mA Adapter • Output: 5V 1.5A Environmental Requirements +5 ~ +30 °C Operating temperature Transportation and storage...
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Page 25: Minimum Computer System Requirements
Note: The quality of images is affected by the quality of the monitor and monitor settings. See your monitor user's guide for information. CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03... - Page 26 22 Chapter 3 Technical Specifications...
- Page 27 Representante no Brasil Carestream do Brasil Comércio e Serviços de Produtos MédicosLtda. Rua Pequetita, 215 cjs. 31 E 32 Edifício Atrium VII - Vila Olímpia São Paulo - Brazil CEP (Zip code): 04552-060 CS 1200 Intraoral Camera Safety, Regulatory, and Technical Specifications User Guide (9H1808)_Ed03...
- Page 28 Carestream Dental A Division of Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 For more information, visit: www.carestreamdental.com ©Carestream Health, Inc., 2016. 9H1808 Ed03 2017-04...
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