Carestream DENTAL CS 8100 Series User Manual
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Carestream DENTAL CS 8100 Series User Manual

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Safety, Regulatory and Technical Specifications User Guide

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  • Page 1 Safety, Regulatory and Technical Specifications User Guide...
  • Page 2 The information contained in this guide may be subject to modification without notice, justification or notification to the persons concerned. No part of this guide may be reproduced without the express permission of Carestream Dental LLC. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.

  • Page 3: Table Of Contents

    Contents 1 Safety Information ..............- 4 - Indications for Use ..................... - 4 - Conventions in this Guide ..................- 4 - Note to the User ......................- 5 - Warning and Safety Instructions ................- 5 - Hygiene and Disinfection ..................- 7 - Marking and Labeling Symbols ................

  • Page 4: Safety Information

    Safety Information Indications for Use The CS 8100 Family are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of health care professionals of the dento-maxillofacial region of the human anatomy as diagnostic support for pediatric and adult patient. In addition, the CS 8100SC and CS 8100SC Access are also intended to produce cephalometric images.

  • Page 5: Note To The User

    Note to the User WARNING: X-rays can be harmful and dangerous if not used properly. The instructions and warnings contained in this guide must be followed carefully. As a manufacturer of radiology units that conform to stringent radiological protection standards in force throughout the world, we guarantee as low as reasonably achievable degree of protection against radiation hazards.
  • Page 6 Product is installed incorrectly and as a result is not operating correctly or is damaged, it is the responsibility of the Distributor. The above will lead to an expiration of the warranty and the liability of Carestream Dental; Carestream Dental accepts no responsibility for failures caused by sub-standard or incorrect installations.

  • Page 7: Hygiene And Disinfection

    Computer  Do NOT place the computer and the peripheral equipment connected to it in the immediate vicinity of the patient in the unit. Leave at least 1.83 m distance between the patient and the unit. The computer and the peripheral equipment must conform to the IEC 60950 standard.
  • Page 8 Cleaning and disinfecting the accessories Cleaning and disinfecting the accessories that have contact with the mucous membranes CAUTION: You MUST cover the standard bite block and the bite block for edentulous pa- tients with FDA-cleared or CE mark protective sheaths that are available from distributors to use them between each patient.
  • Page 9 Disinfecting with Steam Autoclave To steam autoclave the accessory, once cleaning is complete, follow these steps: CAUTION You must use a medical autoclaving equipment cleared by the FDA in the USA or that is recognized by your Local Authority. You must always follow the operating parameters recommended by the manufacturer of the autoclaving equipment.
  • Page 10 Disinfecting 1. Use an intermediate-level disinfectant with tuberculocidal activity as identified above and as recommended by the manufacturer of the disinfectant. 2. Allow to dry in open air. Cleaning and disinfecting the component and accessories that have skin contact The following accessories must first be cleaned and then disinfected between each patient use: ...
  • Page 11 Disinfecting To disinfect the component and accessory, once the cleaning is complete, follow these steps: 1. Disinfect the component and accessory by using an EPA-registered hospital disinfectant for low-level activity or low-level disinfectant that is recognized by your Local Authority (for exam- ple, quaternary ammonium compounds and some phenolics).

  • Page 12: Marking And Labeling Symbols

    Marking and Labeling Symbols Type B device symbol complying with the IEC 60601-1 standard 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 WARNING...

  • Page 13: Label Locations

    Label Locations CS 8100 Labels The following figure illustrates the label locations of the CS 8100 and CS 8100 Access. This figure illustrates only the CS 8100 model but it also applies to the CS 8100 Access model. Figure 1 CS 8100 Label Locations Important: * Only for USA: This warning appears in the Parameter pane of the Acquisition...
  • Page 14 CS 8100SC Labels The following figure illustrates the label locations of the CS 8100SC and CS 8100SC Access. This figure illustrates only the CS 8100SC model but it also applies to the CS 8100SC Access model. Figure 2 CS 8100SC Label Locations Important: * Only for USA: This warning appears in the Parameter pane of the Acquisition interface.

  • Page 15: Regulatory Information

    Regulatory Information General Regulatory Information Compliance with European and International Standards Medical Electrical Equipment, Part 1: General Requirements for EN/IEC 60601-1 basic safety and essential performance. Medical Electrical Equipment, Part 1-2: General requirements for EN/IEC 60601-1-2 basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and tests.
  • Page 16 Classification in Accordance with EN/IEC 60601-1 Type of protection against electric shock Class 1 equipment Degree of protection against electric shock Type B Protection against harmful ingress of water Ordinary equipment Operation mode Continuous operation with intermittent loading Flammable anesthetics Not suitable for use in presence of flammable anesthetics or a mixture of flammable anesthetics with air or oxygen or nitrous oxide...
  • Page 17 Use limitation: the use of accessories, cables, or transducers other than those specified in the user’s guide with the exception of cables, accessories or transducers sold by Carestream Dental LLC as replacement parts of internal components, may result in increased emissions or decreased immunity of CS 8100 Family.
  • Page 18 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) CS 8100 Family is intended for use in the electromagnetic environment specified below. The customer or the user of CS 8100 Family should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance...
  • Page 19 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity CS 8100 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8100 Family should assure that it is used in such an environment. The essential performance concerns accuracy of loading factors (mA, kV), if the ESSENTIAL PERFORMANCE is lost or degraded due to EM DISTURBANCES, the system stops the examination and the user is notified of the error.

  • Page 20: Compliance With International Regulations

    Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) CS 8100 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8100 Family should assure that it is used in such an environment. Immunity Test Compliance Level Electromagnetic Environment - Guidance 3 Vrms...

  • Page 21: Technical Specification

    Technical Specification Factory TROPHY 4, rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France Manufacturer Model CS 8100 CS 8100 Access CS 8100SC CS 8100SC Access CS 8100 Family Technical Specification Table 3 CS 8100 Family Technical Specification Components X-ray Generator Tube voltage...
  • Page 22 CS 8100 CS 8100SC Components CS 8100 Access CS 8100SC Access Panoramic Modality Sensor technology CMOS 6.4 x 131.2 mm (adult) Image field 6.4 x 131.2 mm 6.4 x 120 mm (pediatric) Gray scale 4096 - 12 bits 1.2 (±10 %) Magnification Full panoramic Segmented panoramic...
  • Page 23 CS 8100 CS 8100SC Components CS 8100 Access CS 8100SC Access Input voltage (AC) 100 - 240 V 50/60 Hz Unit dimensions 330 (L) x 834 (D) x 1596 (H) mm 1842 (L) x 936 (D) x 1596 (H) mm Minimum required 1200 (L) x 1400 (D) x 2400 (H) mm 2000 (L) x 1400 (D) x 2400 (H) mm...

  • Page 24: Minimum Computer System Requirement

    Minimum Computer System Requirement The computer and the peripheral equipment must conform to the IEC 60950 standard. Item Viewing Acquisition 2 GHz Intel Duo Core 2 GHz Intel Duo Core 4 GB for CS 8100 and CS 8100 Access 4 GB 8 GB for CS 8100SC and CS 8100SC Access ...

  • Page 25: X-Ray Dose Emission Information

    X-Ray Dose Emission Information Radiation protection CAUTION This device is NOT intended for use on patients who are less than 21 kg (46 lb) (approximately) in weight and 113 cm (44.5 in) in height. These measure- ments correspond approximately to that of an average 5 year old child.
  • Page 26 recommend that you select the appropriate FoV size according to the size of your patient’s head. Especially for children and adolescent patients, use the two smallest FoV sizes instead of the 26x24 FoV. Particularly for interceptive treatment made for children below 12 years old, we strongly recommend that you limit the FoV to 18x18.
  • Page 27 Panoramic mode for CS 8100 and CS 8100 Access Table 5 Patient Dose information for Panoramic modality Patient size Radiological exam Area of interest Large Medium Small Child DAP* in mGy.cm.cm Full Panoramic Incisors, molars and TMJ Segmented Panoramic Anterior Incisor Segmented Panoramic Anterior and Incisors, one molar block and...
  • Page 28 Panoramic mode for CS 8100SC and CS 8100SC Access Table 6 Patient Dose information for Panoramic modality Patient size Radiological exam Area of interest Large Medium Small Child DAP* in mGy.cm.cm Full Panoramic Incisors, molars and TMJ Segmented Panoramic Incisor Anterior Segmented Panoramic Incisors, one molar block and TMJ...
  • Page 29 Note: The information in the table above may be subject to modification. Without notice or justification to those concerned. Cephalometric mode Table 7 Patient Dose information for Cephalometric modality for Lateral exam Patient size Program Large Medium Small Child DAP* in mGy.cm.cm 18x18 High resolution 18x18 Fast 18x24 High resolution...
  • Page 30 *DAP: Dose Area Product. The accuracy of DAP in the table above is +/-30 % when compared with the values that could be measured. Note: The information in the table above may be subject to modification. Without notice or justification to those concerned. Table 9 Patient Dose information for Cephalometric modality for Frontal AP / PA, Oblique and Submento-vertex exam Patient size...
  • Page 31 User Dose information Stray radiation Stray radiation measures are highly dependent on environmental conditions, such as the composition of walls and their locations, therefore in certain circumstances the values may be significantly different. The points of measurement used are at 0.5 m, 1.0 m and 2.0 m respectively from the central rotation axis.

  • Page 32: Imaging Performance Information

    Stray radiation measured at the maximum use rate permitted by the X-Ray generator, (this corresponds to a continuous average anodic power of 33 W), or 13 exams per hour. Distance between the rotation axis and measurement point ( Circular Stray radiation* Points of Measurement 0.5 m 60 µGy /h...

  • Page 33: Cs 8100 Family Environmental Requirements

    CS 8100 Family Environmental Requirements Ambient Operating Conditions 10 - 35 °C (50 - 95 °F) Temperatures 30 - 80 % Relative humidity 700 - 1060 hpa Atmospheric pressure Up to 3000 m Altitude Storage Conditions Temperatures -10 - 60 °C (14 - 140 °F) Relative humidity 10 - 90 % Atmospheric pressure...

  • Page 34: Cs 8100 Family Electrical Specifications

    CS 8100 Family Electrical Specifications 100 - 240 V ~ (± 10%) 50/60 Hz, Type of Electrical Power Supply Single-Phase Acceptable fluctuation ± 10% 0.12 Ω max Apparent resistance of the power supply circuit Permanent absorbed current 1.0 A Current absorbed during the X-ray emission 20 A Maximum absorbed power 2.2 kVA...
  • Page 35 Accuracy of the Load Parameters High voltage kV ± 10 % Current in the tube mA ± 20 % Exposure time seconds Seconds ± (10 % + 1ms) or ±(5% + 50 ms) Measurement Conditions Indirect on the peak kilovolt meter Direct measurement in the circuit using an oscilloscope Exposure time...

  • Page 36: X-Ray Tube Assembly Technical Specifications

    X-ray Tube Assembly Technical Specifications Table 10 Filtration of the Material in the X-ray Field Standard Compliant IEC 60601-1-3 Compliant Nominal value of the inherent filtration at 70 kV >1.7 mm (0.06'') eq. Al Nominal value of the supplementary filtration at 1.5 mm (0.05'') Al 70 kV Nominal value of the total filtration at 70 kV...
  • Page 37 Figure 5 Location of the Reference Axis for Cephalometric Imaging Table 11 Technical Specifications of the X-ray tube Assembly Standard Compliant Manufacturer Trophy Degree of protection against electric shock Class I Degree of patient protection from the parts Type B applied to the leakage current Operation mode Continuous operation with intermittent loading...
  • Page 38 Figure 6 Heating and Cooling Curves of the X-ray Tube Assembly Beam Limitations of the X-ray Tube Assembly Table 12 Manufacturer Trophy Type Rigidly mounted unit with fixed window dimensions, not removable, and integrated x- ray generator Maximum symmetrical field of radiation in 5 mm x 132 mm panoramic mode at a distance of 540 mm from At the detector reference plane...
  • Page 39 Table 13 Characteristics of the X-ray Tube Toshiba or Canon Siemens Manufacturer’s name D-054 SR 90/15 FN Type OPX105 90 kV Nominal high voltage 105 kV 100 kV 1755 W (at 1.0 s) 1395 W (at 1.0 s) Nominal anode input power 2000 W (at 0.1 s) 35 kJ 19.5 kJ...
  • Page 40 Figure 7 X-ray tube drawing: OPX105 Figure 8 X-ray tube drawing: D-054 Figure 9 X-ray tube drawing: SR 90/15 FN CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13...
  • Page 41 Figure 10 Heating and Cooling Curves of the X-ray Tube: OPX 105 Figure 11 Single Load Chart of the X-ray Tube: OPX 105 Figure 12 Filament Emissions of the X-ray Tube: OPX 105 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13...
  • Page 42 Figure 13 Heating and Cooling Curves of the X-ray Tube: D-054 Figure 14 Single Load Chart of the X-ray Tube: D-054 Figure 15 Filament Emissions of the X-ray Tube: D-054 CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13...
  • Page 43 Figure 16 Heating and Cooling Curves of the X-ray Tube: SR 90/15 FN Figure 17 Single Load Chart of the X-ray Tube: SR 90/15 FN Figure 18 Filament Emissions of the X-ray Tube: SR 90/15 FN CS 8100 Family Safety, Regulatory & Technical Specification (SM785) _Ed13...

  • Page 44: Contact Information

    Trophy 4, rue F. Pelloutier, Croissy-Beaubourg 77435 Marne La Vallée Cedex 2, France 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...
  • Page 45 For more information, visit: www.carestreamdental.com SM785 Ed13 2019-04...

This manual is also suitable for:

Cs 8100Cs 8100 accessCs 8100scCs 8100sc access

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