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Summary of Contents for Carestream CS 1500
- Page 1 Safety & Regulatory Guide...
- Page 2 The CS 1500 is intended for professional use only. US Federal law restricts this device to sale by or on the order of a dentist. The CS 1500 intraoral camera is also marketed and sold as the WAVE PICT + intraoral camera.
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Page 3: Table Of Contents
Ring Cover ... 6 Cleaning and Disinfecting the CS 1500 ... . 6 Cleaning the Camera ..6 Disinfecting the Camera . - Page 4 EMC Standards for Intraoral Camera ....19 Wireless: ... .19 Electromagnetic Interference and Electrostatic Discharge ..20 Conforming with European and International Standards .
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Page 5: Conventions In This Guide
Warns you to avoid injury to yourself or others by following the safety instructions precisely. Important: Alerts you to a condition that might cause problems. Note: Emphasizes important information. Provides extra information and hints. CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... -
Page 6: Warnings And Safety Instructions
Warnings and Safety Instructions WARNINGS: Camera • You MUST read and understand this safety information before using the camera. • This 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 the mains supply, unplug the USB/AV/S-Video cables and the adapter from the power outlet. CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04...
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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 the CS 1500 and accessories regularly. To ensure maximum hygienic safety for the patient, carefully follow the instructions to prepare the CS 1500 camera for use. To minimize the risk of cross-contamination, after each patient, clean and disinfect the CS 1500. -
Page 10: Cleaning The Plastic Button Ring Cover
Isopropanol, Ethylene Glycol Monobutly Ether (2-Butoxyethanol), or similar ingredients to clean the plastic ring cover. Cleaning and Disinfecting the CS 1500 Cleaning the Camera If the camera is visibly contaminated with blood or body fluids, you must clean the camera before disinfecting it. -
Page 11: Visually Inspecting The Camera For Damage
Visually Inspecting the Camera for Damage Visually inspect the camera for signs of deterioration, especially around the buttons or the cable. If damage is noted, do not use the camera and contact your representative. CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... -
Page 12: Disposing Of The Battery
Disposing of the Battery The battery is a user-replaceable part ordered directly from the distributor or dealer. To dispose of the battery, follow these steps: Press the Battery Release button (A) and gently pull the battery out. Hold the camera in one hand, and use your other hand to push the new battery into the bottom of the camera. -
Page 13: Marking And Labeling Symbols
Non-ionizing radiation Class II equipment Attention: Consult accompanying documentation. Refer to instruction manual/booklet. Direct current Manufactured date Manufacturer’s address Serial number CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... -
Page 14: Label Locations
Label Locations Wireless Connection Figure 1 CS 1500 Camera Wireless Shipping Label, Battery Label MODEL 锐珂（ 上海） 医疗器材有限公司 中国（ 上海） 自由贸易试验区 川桥路 1510 号第七幢通用厂房 邮编： 201206 中国制造 Figure 2 CS 1500 Camera Wireless Label This device complies with Part 15 of the FCC Rules. - Page 15 CS 1500 Camera Wireless FCC Canadian Statement, Handpiece Label MODEL FCC ID:U72KODAK1500H IC:7027A-KODAK1500 Figure 5 CS 1500 Camera Battery Label Figure 6 CS 1500 Camera Wireless Charge Station Insert Indicative Label CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04...
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Page 16: Wired Usb Connection
Wired USB Connection Figure 7 CS 1500 Camera Wired USB Shipping Label MODEL 锐珂（ 上海） 医疗器材有限公司 中国（ 上海） 自由贸易试验区 川桥路1510号第七幢通用厂房 邮编： 201206 中国制造 Figure 8 CS 1500 Camera Wired USB System Label VIDEO CLASS 12 Chapter 2 Regulatory Information... - Page 17 Figure 9 CS 1500 Camera Rapid USB Cable Label CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04...
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Page 18: Indications For Use
Indications for Use The CS 1500 intraoral camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes • Allowing practitioners to view regions of the oral cavity. • Assisting communications with the patient by providing a view of treatment areas before and after a procedure. -
Page 19: Guidance And Manufacturer's Declarations
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The CS 1500 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 20 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 1500 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 21: Emc Standards Information
Electromagnetic Immunity for Equipment and Systems Fully Compliant with IEC 60601-1-2: 2007 The CS 1500 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 22: Recommended Separation Distances
Mobile RF Communications Equipment and the Intraoral Camera System The CS 1500 intraoral camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the intraoral camera can help prevent electromagnetic interference by maintaining a minimum distance... -
Page 23: Emc Standards For Intraoral Camera
(2) this device must accept any interference received, including interference that may cause undesired operation. Wireless: USA and Canada: FCC Part 15:2008 RSS-210 (Issue 7):2007 RSS-Gen (Issue 2):2007 RSS-102 (Issue 3):2007 Europe: EN 300 328 V1.7.1:2008 EN 50371:2002 CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... -
Page 24: Electromagnetic Interference And Electrostatic Discharge
Electromagnetic Interference and Electrostatic Discharge According to CISPR11:2009+A1:2010 Group 1, Class B. This Class A ISM device complies with Canadian ICES-001. This device has been designed to operate with the antenna listed below, and having a maximum gain of 1.6 dB. Antennas not included in this list or having a gain greater than 1.6 dB are strictly prohibited for use with this device. - Page 25 ANSI/AAMI ES60601-1: Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04...
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Page 26: Communications Equipment
Other Equipment The CS 1500 intraoral camera should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the CS 1500 intraoral camera should be observed to verify normal operation in the configuration in which it will be used. -
Page 27: Cabling
Unshielded DC Power Charge Station Docking Station - 1.5 m Shielded Signal Computer Docking Station - 1.5 m Shielded Signal Monitor (AV) Docking Station - 1.5 m Shielded Signal Monitor (S-Video) CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... - Page 28 24 Chapter 2 Regulatory Information...
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Page 29: Manufacturer
1 SD card socket • 1 DC power output Sensor technology 1/2.5 inch CMOS Resolution 1024 x 768 pixels Super white LEDs / Class 1 LED according to Lighting IEC 60825-1 CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... - Page 30 Components Technical Specifications 80° View angle 90° Connecting cable length 2.5 m • S-Video • Video signal TV (PAL, NTSC) • • USB 2.0 high speed Digital connection • WiFi 802.11 g White balance Automatic Output impedance 75 ohm 100-240V~, 50/60Hz, 600mA Adapter output: DC 6V/2.5A Adapter...
- Page 31 Transportation and storage temperature Operating relative humidity 10 ~ 85% RH Transportation and storage relative 10 ~ 95% RH humidity Operating atmospheric pressure 700-1060 hPa Transportation and storage 600-1060 hPa atmospheric pressure CS 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04...
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Page 32: Minimum Computer System Requirements
Minimum Computer System Requirements If necessary, you must update your computer system configuration. Minimum System Item Requirement 1.8 GHz Intel Pentium IV 2 GB 1024 x 768 minimum screen resolution - 32 Monitor bits color mode • Windows 8 or 8.1 (32 or 64 bits) Windows 7 (32 or 64 bits) •... -
Page 33: Manufacturer's Address
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 1500 Intraoral Camera Safety and Regulatory Guide (9H0953)_Ed04... - Page 34 Carestream Dental A Division of Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 For more information, visit: www.carestreamdental.com To give documentation feedback, visit: www.carestreamdental.com/documentationfeedback ©Carestream Health, Inc., 2014. 9H0953 Ed04 2017-04...
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