Carestream Dental CS 1500 A Division of Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 USA Safety & Regulatory Guide For more information, visit: www.carestreamdental.com To give documentation feedback, visit: www.carestreamdental.com/documentationfeedback ©Carestream Health, Inc., 2012.
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.
Contents Chapter 1 Safety Information Chapter 2 Regulatory Information Conventions in This Guide . . . Warnings and Safety Instructions . . . . . . . . . . Camera . . . . . . . . . . . Computer . . . . . . . . . . Hygiene and Disinfection. . . . General Warnings . . . . . Cleaning the Plastic Button Ring Cover . . . . . . . . . Cleaning and Disinfecting the CS 1500 . . . . . . . . . . Cleaning the Camera . . Disinfecting the Camera . Visually Inspecting the Camera for Damage . . . . . . . . . .
Accessories . . . . . . . . . . . .21 Other Equipment . . . . . . . . .21 Cabling . . . . . . . . . . . . . .22 Chapter 3 Technical Specifications Chapter 4 Contact Information iv Factory . . . . . . . . . . Manufacturer . . . . . . . Model . . . . . . . . . . . Technical Specifications . . Minimum Computer System Requirements . . . . . . . . . . . . . . . . . . . .23 .23 .23 .23 . . . .26 Manufacturer’s Address . . . . . .27 Authorized Representatives . . . .
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.
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.
• 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.
• 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.
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.
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.
To disinfect the camera, follow these steps: 1 Remove the protective sheath. 2 Remove all visible soil (see “Cleaning the Camera” on page 6). 3 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. 4 Thoroughly wet the surface of the camera with the disinfectant solution.
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 Make sure the battery is locked into place.
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.
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.
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.
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 CS 1500 intraoral camera should assure that it is used in such an environment. Compliance Level Electromagnetic Environment - Guidance ±8 kV contact ±15 kV air ±8 kV contact ±15 kV air Floors should be wood, concrete, or ceramic tile.
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 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 Environment of a professional healthcare facility.
Guidance and Manufacturer’s 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.
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.
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.
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: Ge
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 IPX0 Note: When it is covered by the protective sheath, the camera head is IPX1. Flammable anesthetics Not suitable for use in the presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide.
Cabling Interface Max. Cable Length Number of interfaces Shielded/ Cable with Unshielded identical Classifications electrical characteristics AC Docking Station - Camera 2.5 m Unshielded 1 AC - DC Adapter Docking Station Camera 2.5 m Shielded 1 Signal, DC Power (USB) Docking Station Charge Station 2.5 m Unshielded 1 DC Power Docking Station Computer 1.5 m Shielded 1 Signal Docking Station Monitor (AV) 1.5 m Shielded 1 Signal Docking Station Monitor (S-Video) 1.
3 Technical Specifications Factory Rayco (Shanghai) Medical Products Company Limited Building 7, No.
Components Technical Specifications Lighting Super white LEDs / Exempt group LED according to IEC/EN 62471 FOV 80° View angle 90° Connecting cable length 2.5 m Video signal • • • S-Video TV (PAL, NTSC) VGA Digital connection • • USB 2.0 high speed WiFi 802.11 g White balance Automatic Output impedance 75 ohm Adapter 100-240V~, 50/60Hz, 500mA output: DC 6.1V/2.5A Adapter AC adapter complies with IEC 60601-1 Output of adapter DC 6.1V, 2.
Components Technical Specifications Docking station 225 g Charge station 180 g Environment ° Operating temperature +5 ~ 30 C Transportation and storage temperature -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. Minimum System Requirement Item CPU 1.8 GHz Intel Pentium IV RAM 2 GB Monitor 1024 x 768 minimum screen resolution - 32 bits color mode Operating system • • • Windows 7 (32 or 64 bits) Windows 8 or 8.1 (32 or 64 bits) Windows 10 (64 bits) USB port USB 2.0 high speed port CD/DVD drive DVD-ROM drive is required to install the product.
4 Contact Information Manufacturer’s Address www.carestreamdental.com Authorized Representatives Authorized Representative in the European Community EC REP Trophy 4, Rue F. Pelloutier Croissy-Beaubourg 77435 Marne-la-Vallée, 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.
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 28 Chapter 4 Contact Information
CS 1500 For more information, visit: www.carestreamdental.com To give documentation feedback, visit: www.carestreamdental.com/documentationfeedback ©Carestream Dental, LLC, 2019.
