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User Manual | Users Manual | 1.28 MiB | January 07 2019 | |||
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1 | User Manual | Users Manual | 1.28 MiB | January 07 2019 |
Carestream Dental A Division of Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 USA 0 0 5 1 S C For more information, visit: www.carestreamdental.com To give documentation feedback, visit:
www.carestreamdental.com/documentationfeedback Safety & Regulatory Guide Carestream Health, Inc., 2012. 9H0953 Ed01 2012-01 Notice Carestream Dental LLC, 2019. The information in this document is subject to change. Neither Carestream Dental LLC 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. No part of this publication may be reproduced without the permission of Carestream Dental LLC. All trademarks and registered trademarks are the property of their respective holders. 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. Manual Name: CS 1500 Intraoral Camera Safety and Regulatory Guide Part Number: 9H0953 Revision Number: 06 Print Date: 2019-02 Contents Chapter 1 Safety Information Chapter 2 Regulatory Information Conventions in This Guide . . . . . 1 Warnings and Safety Instructions . . . . . . . . . . . . 2 Camera . . . . . . . . . . . . . 2 Computer . . . . . . . . . . . . 4 Hygiene and Disinfection. . . . . . 5 General Warnings . . . . . . . 5 Cleaning the Plastic Button Ring Cover . . . . . . . . . . . 6 Cleaning and Disinfecting the CS 1500 . . . . . . . . . . . . 6 Cleaning the Camera . . . . 6 Disinfecting the Camera . . . 6 Visually Inspecting the Camera for Damage . . . . . . . . . . . . 7 Disposing of the Battery . . . . . . 8 Marking and Labeling Symbols . . . 9 Label Locations . . . . . . . . . 10 Wireless Connection . . . . . 10 Wired USB Connection . . . . 12 Indications for Use . . . . . . . . 13 Regulatory Information . . . . . . 13 Electromagnetic Compatibility Precautions . . . . . . . . . . . 14 Guidance and Manufacturers Declarations . . . . . . . . . 14 EMC Standards for Intraoral Camera . . . . . . . . . . . . . 18 Wireless: . . . . . . . . . . . 18 Electromagnetic Interference and Electrostatic Discharge . . . . 19 Conforming with European and International Standards . . . . 19 Communications Equipment . . . 21 CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 iii Chapter 3 Technical Specifications Accessories . . . . . . . . . . . .21 Other Equipment . . . . . . . . .21 Cabling . . . . . . . . . . . . . .22 Factory . . . . . . . . . . . . . .23 Manufacturer . . . . . . . . . . .23 Model . . . . . . . . . . . . . . .23 Technical Specifications . . . . . .23 Minimum Computer System Requirements . . . . . . . . . . .26 Chapter 4 Contact Information Manufacturers Address . . . . . .27 Authorized Representatives . . . .27 iv 1 Safety Information Conventions in This Guide The following special messages emphasize information or indicate potential risks to personnel or equipment. WARNING: 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. Tip: Provides extra information and hints. CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 1 Warnings and Safety Instructions WARNINGS:
Camera You MUST read and understand this safety information before using the camera. The system should be used in the hospital environment except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high. 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. The surface temperature of the LED window may rise to 40C. Do not allow the window to come in contact with the patients mouth for more than 10 minutes. You are responsible for the operation and maintenance of this camera. You MUST have training to use the camera. DO NOT place objects within the field of operation of the unit. When the unit is not in use, ensure that the camera is turned OFF. DO NOT use this camera in conjunction with oxygen-rich environments. This unit is not intended for use with flammable anesthetics or flammable agents. DO NOT pull or twist the cable. DO NOT drop the camera. 2 Chapter 1 Safety Information DO NOT expose the camera to water spray or submerge it in water. DO NOT expose the camera to high vibrations. DO NOT expose the camera to ultraviolet radiation for a long period. Any other equipment not complying with IEC60601 shall be kept at least 1.83 meters away from the patient. DO NOT remove the cover of any camera components. For any repairs, contact a qualified Carestream Dental service technician. DO NOT replace the cables provided with the camera with other cables. Doing so may damage the camera and adversely affect the safety protection and EMC performance of the camera. DO NOT replace the power adapter provided with the camera with any other power adapter. Substitutes may not provide the required protection against electric shocks and other safety hazards. If the equipment is faulty, turn it OFF, display an Out of Service notice, and contact a service technician. Using components, accessories, cables, and spare parts other than those specified or provided by the manufacturer of this equipment may impair the safety protection of the camera and may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Do not stare at the LED emission window. No modification of this equipment is allowed. Additional multiple outlet strips or extension cords should not be connected to the system. CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 3 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. 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 a computer that has agency approval according to the latest edition of applicable safety and EMC standards. Connecting the camera to other equipment may be hazardous. See the installation guide for your computer for information about the data processing system, computer, and screen. Leave a sufficient amount of clear space around the computer to ensure that it is properly ventilated. Position the screen to avoid light reflections from internal or external lighting for maximum image quality and visual comfort. 4 Chapter 1 Safety Information 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. See Cleaning and Disinfecting the CS 1500 on page 6. General Warnings WARNINGS:
Read and follow the warnings and personal protection instructions provided in the Safety Data Sheet (SDS) of the disinfectant before use. The disinfectant should be approved by the applicable competent authority for use on a dental medical device. You must wear gloves while handling and using the camera. Always protect the camera with a hygienic barrier sheath before use. The camera should be disinfected with a U.S. Environmental Protection Agency (EPA)-
registered or CE-marked intermediate-level disinfectant solution with tuberculocidal activity between patients. DO NOT use a disinfectant containing phenolics or iodophors; doing so will damage the surface coating of the camera. Never put the camera in a sterilizing device or immerse it in water or the disinfectant solution. Excessive fluids can damage the camera. Not protected against water spray. CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 5 Cleaning the Plastic Button Ring Cover Use a 75% Ethanol cleaning solution to prevent cracks, chips, or other damage to the plastic button ring cover. Caution: Do not use disinfectants containing Diisobutylphenoxyethoxyethyldimethylbenzyl ammonium chloride, 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. To clean the camera, follow these steps:
1 2 Dampen (do not soak) a lint-free cloth with lukewarm water. Remove the blood or body fluids with the dampened lint-free cloth. Disinfecting the Camera After each patient, the camera must be thoroughly disinfected. To adequately disinfect the camera, follow the disinfectant manufacturers instructions for the appropriate contact time. Important: If the camera is visibly soiled, it must be thoroughly cleaned prior to disinfecting. See Cleaning the Camera. 6 Chapter 1 Safety Information To disinfect the camera, follow these steps:
1 2 3 4 Remove the protective sheath. Remove all visible soil (see Cleaning the Camera on page 6). Dampen (do not soak) a lint-free cloth with 0.525% sodium hypochlorite
(1:10 dilution of household bleach), or use a commercially prepared disinfectant wipe. For example: Clorox Healthcare Bleach Germicidal Wipes, if in the USA. Thoroughly wet the surface of the camera with the disinfectant solution. Allow the surfaces to remain wet for the time specified by the disinfectant manufacturer. Warning: Do not rinse. 5 Allow to dry in the open air. 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)_Ed06 7 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:
1 Press the Battery Release button (A) and gently pull the battery out. A 2 Hold the camera in one hand, and use your other hand to push the new battery into the bottom of the camera. 3 4 Make sure the battery is locked into place. To make sure that the battery and all the cables are inserted correctly, press the ON/OFF for 3 seconds to power ON the camera. When the battery has reached the end of its useful life, properly dispose of the battery following all local regulations. Your community may offer a battery collection program. Check with program sponsors for participation details. 8 Chapter 1 Safety Information 2 Regulatory Information Marking and Labeling Symbols Type BF applied part symbol classification in accordance with IEC 60601standards. In the European Union, this symbol indicates: DO NOT discard this product in a trash receptacle; use an appropriate recovery and recycling facility. Contact your local sales representative for additional information on the collection and recovery programs available for this product. Non-ionizing radiation Class II equipment Attention:
Consult accompanying documentation. Refer to instruction manual/booklet. Direct current Manufactured date Manufacturers address Serial number CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 9 Label Locations Wireless Connection Figure 1 CS 1500 Camera Wireless Shipping Label, Battery Label Figure 2 CS 1500 Camera Wireless Label 10 Chapter 2 Regulatory Information Figure 3 CS 1500 Camera Wireless Charge Station Label Figure 4 CS 1500 Camera Wireless FCC Canadian Statement, Handpiece Label 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)_Ed06 11 Wired USB Connection Figure 7 CS 1500 Camera Wired USB Shipping Label Figure 8 CS 1500 Camera Wired USB System Label 12 Chapter 2 Regulatory Information Figure 9 CS 1500 Camera Rapid USB Cable Label 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 of:
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. Providing images for documentation in patient records. There are two configurations for the camera: wired USB and wireless. The wireless configuration is composed of a camera, a docking station, a charge station, and accessories. The wired USB is composed of a camera only. Regulatory Information The CS 1500 intraoral camera complies with the following regulations:
93/42/EEC European Economic Community Medical Devices Directive, as amended by Directive 2007/47/EC, class I following rule 5 Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) Radio Equipment Directive 2014/53/EU (Wireless ONLY) FDA Center for Devices & Radiological Health CDRH - Title 21 CFR 872.6640 (USA) Medical Devices Regulations (Canada) CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 13 Electromagnetic Compatibility Precautions Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Medical equipment must be installed and put into service according to the EMC information provided in this documentation. Other equipment can interfere with communications with the intraoral camera, even if the equipment complies with CISPR emissions requirements. Warning: Portable and Mobile 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 intraoral camera, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Guidance and Manufacturers Declarations Guidance and Manufacturers Declaration -
Electromagnetic Emissions The CS 1500 intraoral camera is intended for use in the electromagnetic environment specified below. The customer or user of the CS 1500 intraoral camera should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Group 1 Class B Harmonic Emissions IEC 61000-3-2 Class A Voltage Fluctuations/
Flicker Emissions IEC 61000-3-3 Complies The CS 1500 intraoral camera uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The CS 1500 intraoral camera is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 14 Chapter 2 Regulatory Information Guidance and Manufacturers 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 CS 1500 intraoral camera should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 8 kV contact 15 kV air 8 kV contact 15 kV air Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2 kV for power supply lines 2 kV for power supply lines 1 kV line to line 1 kV line to line 0% UT; 0,5 cycle At 0, 45, 90, 135, 180, 225, 270, and 315 0% UT; 1 cycle and 70% UT; 25/30a cycles Single phase: at 0 0% UT; 250/300a cycles 0% UT; 0,5 cycle At 0, 45, 90, 135, 180, 225, 270, and 315 0% UT; 1 cycle and 70% UT; 25/30a cycles Single phase: at 0 0% UT; 250/300a cycles Power frequency
(50/60Hz) magnetic field IEC 61000-4-8 30 A/m 30 A/m Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the CS 1500 intraoral camera requires continued operation during power mains interruptions, it is recommended that the CS 1500 intraoral camera be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. a) e.g., 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz NOTE: UT is the a.c. mains voltage prior to application of the test level. CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 15 Guidance and Manufacturers 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 CS 1500 intraoral camera should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment -
Guidance Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM bands between 150 kHz and 80 MHza 6 Vrms in ISM bands between 150 kHz and 80 MHza Environment of a professional healthcare facility. WARNING: 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 1500, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7GHz 3 V/m 80 MHz to 2.7GHz a The ISM (industrial, scientific and medical) bands between 150 k Hz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. NOTE: Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CS 1500 intraoral camera is used exceeds the applicable RF compliance level above, the CS 1500 intraoral camera should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CS 1500 intraoral camera. 16 Chapter 2 Regulatory Information Guidance and Manufacturers Declaration -
Electromagnetic Immunity For the immunity to proximity fields from RF wireless communications equipment, the CS 1500 intraoral camera is compliant with the test levels specified below, according to IEC60601-1-2 standard. The customer or user of the CS 1500 intraoral camera should assure that it is used in such an environment. Test Frequency
(MHz) Band
(MHz) Immunity Test Levels 380-390 Pulse modulation 18Hz, 27V/m 430-470 FM, 5 kHz deviation, 1 kHz sine, 28V/m 704-787 Pulse modulation 217Hz, 9V/m 800-960 Pulse modulation 18Hz, 28V/m 1700-1990 Pulse modulation 217Hz, 28V/m 2400-2570 Pulse modulation 217Hz, 28V/m 5100-5800 Pulse modulation 217Hz, 9V/m 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 17 EMC Standards for Intraoral Camera IEC 60601-1-2: 2014 EMC requirements and tests, Medical Electrical Equipment including CISPR11:2009 +A1: 2010. This equipment complies with radio frequency exposure limits set forth by the FCC and the Innovation, Science and Economic Development Canada for an uncontrolled environment. The docking station should be installed and operated with a minimum distance of 20 cm (7.9 inches) between the device and the user or bystanders. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Cet quipement est conforme aux limites d'exposition aux radiofrquences dfinies par la Innovation, Sciences et Dveloppement conomique Canada pour un environnement non contrl. Cet quipement doit tre install et utilis avec un minimum de 20 cm (7.9 pouces) de distance entre le dispositif et l'utilisateur ou des tiers. Ce dispositif ne doit pas tre utilis proximit dune autre antenne ou dun autre metteur. This device complies with part 15 of the FCC Rules and contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. Caution: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes : (1)Lappareil ne doit pas produire de brouillage;
(2)Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. SAR Value for Handpiece: Limbs: 0. W/kg, 10g Wireless:
USA and Canada:
28 ANSI C63.10:2013 FCC Part 15:2017 RSS-247 (Issue 2):2017 RSS-Gen (Issue 5):2018 RSS-102 (Issue 3):2007 Europe:
EN 300 328 v2.1.1:2016 EN 62479:2010 EN 301 489-1 V2.1.1:2017 EN 301 489-17 V3.1.1:2017 18 Chapter 2 Regulatory Information Electromagnetic Interference and Electrostatic Discharge According to CISPR11:2009+A1:2010 Group 1, Class B. This device has been designed to operate with the antenna listed below and has 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. The required antenna impedance is 50 ohms. Detachable antenna:
Trade Name: Exceltek Conforming with European and International Standards EN 60601-1 / IEC 60601-1: Medical Electrical Equipment, Part 1:
General Requirements for Basic Safety and Essential Performance EN 60601-1-2 / IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances Requirements and tests IEC 60601-2-18: Medical Electrical Equipment, Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment EN 62471 / IEC 62471: Photobiological safety of lamps and lamp systems: Equipment classification, requirements, and Users Guide EN 60601-1-6 / IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: General requirements for basic safety and essential performance -
Collateral Standard: Usability CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 19 EN 62366 / IEC 62366: Medical devices - Application of usability engineering to medical devices EN 62304 / IEC 62304: Medical device software - Software life cycle Processes EN ISO 10993-1: Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process EN ISO 14971: Medical devices - Application of risk management to medical devices EN ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements EN 1041: Information supplied by the manufacturer of medical devices CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment - Part 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 CAN/CSA-C22.2 No. 60601-2-18: Medical Electrical Equipment, Part 2-18:
Particular requirements for the basic safety and essential performance of endoscopic equipment EN 300 328: Electromagnetic compatibility and Radio Spectrum Matters
(ERM): Wideband Transmission systems; Data transmission equipment operating in the 2.4 GHz ISM band and using wideband modulation techniques EN 62479: Assessment of the compliance of low-power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic fields (10 MHz to 300 GHz) EN 301 489-1: Electromagnetic compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements EN 301 489-17: Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems 20 Chapter 2 Regulatory Information Condition Classification Type of protection against electric shock Class II equipment or Internally powered Degree of protection against electric shock Type BF Applied Part Degree of protection against ingress of water Flammable anesthetics IPX0 Note: When it is covered by the protective sheath, the camera head is IPX1. Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide. Mode of operation Continuous operation Communications Equipment The wireless version of the CS 1500 intraoral camera operates with a 802.11g protocol. Each channel central frequency is between 2.412GHz (channel 1) and 2.462GHz (channel 11). The adjacent channel is 5 MHz space apart. The working channel bandwidth is 20MHz. The radio output power is 20 mW
(nominal). Accessories The use of cables, or accessories other than those specified, with the exception of those sold by the manufacturer of the equipment as replacement parts for internal components, may result in increased emissions or decreased immunity of the medical equipment. Other Equipment WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify normal operation. CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 21 Cabling Interface Max. Cable Length Shielded/
Unshielded AC Docking Station - Camera Docking Station -
Camera Docking Station -
Charge Station Docking Station -
Computer Docking Station -
Monitor (AV) Docking Station -
Monitor (S-Video) 2.5 m Unshielded 2.5 m Shielded 2.5 m Unshielded 1.5 m Shielded 1.5 m Shielded 1.5 m Shielded Number of interfaces with identical electrical character-
istics Cable Classifications 1 1 1 1 1 1 AC - DC Adapter Signal, DC Power
(USB) DC Power Signal Signal Signal 22 Chapter 2 Regulatory Information 3 Technical Specifications Factory Rayco (Shanghai) Medical Products Company Limited Building 7, No. 1510 Chuanqiao Road China (Shanghai) Pilot Free Trade Zone 201206 Shanghai PEOPLE'S REPUBLIC OF CHINA Manufacturer Carestream Dental LLC 3625 Cumberland Boulevard, Suite 700 Atlanta, GA USA 30339 Model CS 1500, Wired USB CS 1500, Wireless Technical Specifications Components Technical Specifications Camera Output Sensor technology Resolution 1 S-video output 1 PAL output 1 NTSC output 1 VGA video output 1 digital USB 2.0 output 1 SD card socket 1 DC power output 1/2.5 inch CMOS 1024 x 768 pixels CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 23 Components Technical Specifications Lighting FOV View angle Connecting cable length Video signal Digital connection White balance Output impedance Adapter Adapter Super white LEDs / Exempt group LED according to IEC/EN 62471 80 90 2.5 m S-Video TV (PAL, NTSC) VGA USB 2.0 high speed WiFi 802.11 g Automatic 75 ohm 100-240V~, 50/60Hz, 500mA output: DC 6.1V/2.5A AC adapter complies with IEC 60601-1 Output of adapter DC 6.1V, 2.5A Battery Rapid USB Cable Battery capacity Charging current 650mAh; ICR17/34 Li16340C manufactured by SHENZHEN BOFUNENG BATTERY CO., LTD 650mAh 75mA Recommended first charging time 10 hours Normal charging time Less than 2 hours Note: The battery embedded in the Rapid USB Cable complies with IEC/EN 62133 standard. For the battery disposal instructions, see Disposing of the Battery on page 18. Dimensions Camera Docking station Charge station Weight 191 x 31 x 25 mm 149 x 93 x 32 mm 92 x 58 x 73 mm Camera without cable/battery Camera with battery 61 g 91 g 24 Chapter 3 Technical Specifications Components Technical Specifications Docking station Charge station Environment Operating temperature Transportation and storage temperature 225 g 180 g
+5 ~ 30 C
-10 ~ 60 C Operating relative humidity 10 85% RH Transportation and storage relative humidity 10 95% RH Operating atmospheric pressure 700 1060 hPa Transportation and storage atmospheric pressure 600 1060 hPa CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 25 Minimum Computer System Requirements If necessary, you must update your computer system configuration. Item CPU RAM Monitor Operating system USB port CD/DVD drive Video memory Video card driver Minimum System Requirement 1.8 GHz Intel Pentium IV 2 GB 1024 x 768 minimum screen resolution - 32 bits color mode Windows 7 (32 or 64 bits) Windows 8 or 8.1 (32 or 64 bits) Windows 10 (64 bits) USB 2.0 high speed port DVD-ROM drive is required to install the product. 128M (integrated or dedicated) Support OpenGL version 1.4 or higher The computer should be situated in or close to the operating area, in the visual field of the practitioner when using the camera. Note: The quality of images is affected by the quality of the monitor and monitor settings. See your monitor user's guide for information. 26 Chapter 3 Technical Specifications 4 Contact Information Manufacturers Address www.carestreamdental.com Authorized Representatives Authorized Representative in the European Community EC REP Trophy 4, Rue F. Pelloutier Croissy-Beaubourg 77435 Marne-la-Valle, Cedex 2 France Importer for European Union Carestream Dental Germany GmbH Hedelfinger Str. 60 70327 Stuttgart UST ID Nr. DE815716368 Fax. No. 0711 20 70 7331 Handelsregister Nr.; HRB 760305 WEEE-Reg.Nr.: DE90742102 CS 1500 Intraoral Camera Safety and Regulatory Guide
(9H0953)_Ed06 27 Authorized Representative in Brazil Carestream Dental Brasil Eireli Rua Romualdo Davoli, 65 1 Andar, Sala 01 - So Jos dos Campos So Paulo - Brazil CEP (Zip code): 12238-577 28 Chapter 4 Contact Information 0 0 5 1 S C For more information, visit: www.carestreamdental.com To give documentation feedback, visit:
www.carestreamdental.com/documentationfeedback Carestream Dental, LLC, 2019. 9H0953 Ed06 2019-02
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-07-01 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2019-07-01
|
||||
1 | Applicant's complete, legal business name |
Carestream Dental, LLC
|
||||
1 | FCC Registration Number (FRN) |
0028170819
|
||||
1 | Physical Address |
3625 Cumberland Ave Suite 700
|
||||
1 |
Atlanta, Georgia 30339
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
f******@us.tuv.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2ASFG
|
||||
1 | Equipment Product Code |
CS1500D
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
K****** M******
|
||||
1 | Title |
Radiation Safety Officer
|
||||
1 | Telephone Number |
585-3********
|
||||
1 | Fax Number |
470-4********
|
||||
1 |
K******@CSDental.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Intraoral Camera | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 | Grant Comments | Power output listed is conducted. The antennas used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and not be co-located with any other transmitters except in accordance with FCC multitransmitter product procedures. End-users and installers must be provided with antenna installation instructions and transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
MRT Technology (Suzhou) Co., Ltd.
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1 | Name |
M****** C****
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1 | Telephone Number |
+86-5******** Extension:
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1 |
m******@mrt-cert.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0957000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC