Carestream DENTAL CS 8 200 3D Manual
  1. Manuals
  2. Brands
  3. Carestream DENTAL Manuals
  4. Dental equipment
  5. CS 8 200 3D
  6. Manual

Carestream DENTAL CS 8 200 3D Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Safety, Regulatory and Technical Specifications User Guide

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the CS 8 200 3D and is the answer not in the manual?

Questions and answers

Related Manuals for Carestream DENTAL CS 8 200 3D

Summary of Contents for Carestream DENTAL CS 8 200 3D

  • Page 1 Safety, Regulatory and Technical Specifications User Guide...
  • Page 2 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 - Clinicl benefits and performance characteristics ............. - 5 - Conventions in this Guide ................... - 5 - Note to the User ......................- 6 - Warning and Safety Instructions ................

  • Page 4: Safety Information

    Safety Information Indications for Use The CS 8200 3D is intended to produce complete or segmented tomographic digital panoramic images and three-dimensional digital X-ray images of the dento-maxillofacial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. In addition, the CS 8200 3D can be upgraded to produce cephalometric digital X-ray images.

  • Page 5: Clinicl Benefits And Performance Characteristics

    WARNING: Do not use cone beam imaging for routine or screening examinations. Consider using other diagnostic tools. You must justify that the imaging method that you use to examine each patient demonstrates that the benefit outweighs the risks. Clinicl benefits and performance characteristics CS 8200 3D benefits healthcare professionals by allowing them to acquire digital X-ray images (two-dimensional and three-dimensional) of the dento-maxillofacial regions as diagnostic support for pediatric and adult patients.

  • Page 6: Note To The User

    Important: All known residual risks, contra-indications or undesirable side- effects are listed in this guide. If any serious incident occurs in relation to the device, you must report it to Carestream Dental and to the competent authority in your country.
  • Page 7  The Technician who installs the unit has the responsibility to warn Carestream Dental if the post installation produces a failed error message which, if ignored, can result in the improper installation of the unit. CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02...

  • Page 8: Precaution Before Use

    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 1.83m distance between the patient and the unit. The computer and the peripheral equipment must conform to the IEC 60950-1 or IEC 62368-1 standard.
  • Page 9 6. Dampen (not soak) a lint-free cloth with a low-level disinfectant that is U.S. Environ- mental Protection Agency (EPA)-registered or low-level disinfectant that is recognized by your Local Authority (for example, quaternary ammonium compounds and some phenol- ics). An EPA-registered hospital disinfectant or any other low-level disinfectant must have clear label claims for intended use.
  • Page 10 To clean the accessories that have contact with the mucous membranes, follow these steps: 1. Remove and discard the protective sheath from the accessory. 2. Remove all visible soil by with disposable cloth or paper wipe. 3. Rinse at least 1 minute under running water to thoroughly clean the accessory from any excess soil.
  • Page 11 CAUTION Ear cones must be covered with a use FDA-cleared or CE mark pro- tective sheaths that are available from distributors to use them be- tween each patient. After use, remove and discard the protective sheath. You must clean and disinfect the ear cones between each patient use with an EPA-registered, or CE mark, intermediate-level disinfectant with label claims of tuberculocidal activity.
  • Page 12 To manually clean the accessories that have skin contact, follow these steps: 1. Remove all visible soil by with disposable cloth or paper wipe. 2. Rinse at least 1 minute under running water to thoroughly clean the accessory from any excess soil. 3.

  • Page 13: 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.

  • Page 14: Label Locations

    Label Locations CS 8200 3D Labels The following figures are used only to illustrate the label locations, the labels contents may be different. Figure 1 CS 8200 3D Label Locations Important: * Only for USA: This warning appears in the Parameter pane of the Acquisition interface. ** Canada specific labels.
  • Page 15 Figure 2 CS 8200 3D Label Locations (with Scan Ceph configuration) Important: * Only for USA: This warning appears in the Parameter pane of the Acquisition interface. ** Canada specific labels. *** X-ray tube can be Toshiba/Canon D-067 or CEI OPX110. **** Product label can be CS 8200 3D.

  • Page 16: Regulatory Information

    Regulatory Information General Regulatory Information Compliance with European and International Standards Medical Electrical Equipment - Part 1: General Requirements EN/IEC 60601-1 For Basic Safety and essential performance. Medical Electrical Equipment, Part 1-2: General requirements for basic Safety and essential performance - Collateral EN/IEC 60601-1-2 Standard: Electromagnetic Disturbances - Requirements and tests.
  • Page 17 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 18 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 the CS 8200 3D.
  • Page 19 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 8200 3D is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8200 3D 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) The CS 8200 3D is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8200 3D should assure that it is used in such an environment. Electromagnetic Environment - Immunity Test IEC 60601 Test Level...

  • Page 21: Technical Specifications

    Technical Specifications Model CS 8200 3D CS 8200 3D Technical Specifications Table 2 CS 8200 3D Technical Specifications Components CS 8200 3D X-ray Generator Tube voltage 60-90 kV Tube current 2-15 mA Frequency 140 kHz Tube focal spot 0.7 mm with X-ray tube OPX110 (IEC 60336) 0.6 mm with X-ray tube D-067 Total filtration...
  • Page 22 Components CS 8200 3D 4 patient sizes (child, small adult, medium adult, large adult) Exposure mode 3 dental arch morphology (normal, square, sharp) Exposure time 2 to 14 s 3D Modality Dental Volumetric Reconstruction (DVR) Technology Sensor technology CMOS 4 x 4 Volume Field 5 x 5...
  • Page 23 Components CS 8200 3D Input voltage (AC) 100-240 V - 50/60 Hz 330 (L) x 894 (D) x 1596 (H) mm Unit dimensions 1842 (L) x 936 (D) x 1596 (H) mm (with Scan Ceph configuration) Minimum required 1200 (L) x 1400 (D) x 2400 (H) mm Space 2000 (L) x 1400 (D) x 2400 (H) mm (with Scan Ceph configuration) Weight without the...

  • Page 24: Minimum Computer System Requirement

    Minimum Computer System Requirement The computer and the peripheral equipment must conform to the IEC 60950-1 or IEC 62368-1 standard. Item Viewing Acquisition 2 GHz Intel Duo Core 2,4 Ghz Intel Duo Core 4 GB (16 GB for CS MAR) 16 GB ...

  • 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 measurements correspond approximately to that of an average 5 year old US child. The use of equipment and exposure settings designed for adults of average size can result in excessive radiation exposure for a smaller patient.
  • Page 26 Table 3 Dose reduction options Selecting the appropriate patient size for children/adolescent The two smallest patient size icons represent the exposure values for children and adolescent patients. Both patient sizes are associated to reduced kV / mA values which may reduces the dose related to these exposure parameters.

  • Page 27: Panoramic Mode For Cs 8200 3D

     Children and adolescents can be more still and stable in the seated position. The CS 8200 3D can be brought down for an exposure in the seated position.  To allow proper positioning of a pediatric patient, and where relevant, depending on the patient size, you can use the 3D child bite block accessory instead of the standard 3D bite block.
  • Page 28 Patient size Radiological exam Area of interest Large Medium Small Child mGy.cm.cm DAP* in 98.9 91.8 62.5 Incisors, molars and Full Panoramic 74.9 48.6 35.7 19.3 Segmented Panoramic Incisor Anterior 101.4 73.8 63.7 40.9 Segmented Panoramic Incisors, one molar Anterior and Posterior block and TMJ 96.6 69.7...

  • Page 29: 3D Mode For Cs 8200 3D

    Patient size Radiological exam Area of interest Large Medium Small Child mGy.cm.cm DAP* in 64.7 48.8 45.3 30.8 Incisors, molars and Full Panoramic 58.1 43.4 39.9 26.8 Segmented Panoramic Incisors and molars Anterior and Posterior *DAP: Dose Area Product. The accuracy of DAP in the table above is +/-30 % when compared with the values that could be measured.
  • Page 30 ADULT LARGE ADULT MEDIUM ADULT SMALL CHILD DAP* in DAP* in DAP* in DAP* in T(s) kV mA mGy.cm.cm mGy.cm.cm kV mGy.cm.cm kV mGy.cm.cm FAST 7.0 90 3.2 2 348 3.1 90 3.2 2 113 20 90 1229 2 492 10 x 5 FAST 14.0 90 3.2 2 269...

  • Page 31: Cephalometric Mode For Cs 8200 3D With Scan Ceph Configuration

    Cephalometric mode for CS 8200 3D with Scan Ceph configuration 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 18x24 Fast 26x24 High resolution 26x24 Fast *DAP: Dose Area Product.
  • Page 32 Oblique and Submento-vertex exam Patient size Program Large Medium Small Child DAP* in mGy.cm.cm 18x18 High resolution 18x18 Fast 18x24 High resolution 18x24 Fast 26x24 High resolution 26x24 Fast *DAP: Dose Area Product. The accuracy of DAP in the table above is +/-30 % when compared with the values that could be measured.

  • Page 33: User Dose Information

    User Dose information Stray radiation in Panoramic Mode 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 34: Stray Radiation In 3D Mode

    Stray radiation in 3D Mode 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 35: Stray Radiation In Cephalometric Mode

    Stray radiation in cephalometric mode 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 point of the ears rest.

  • Page 36: Imaging Performance Information

    Imaging performance information Panoramic and Cephalometric Line Pair Resolution*: 2.5 lp/mm minimum. Low Contrast Resolution*: a minimum of 2 low contrast steps for panoramic and a minimum of 1 low contrast step for cephalometric. * Using a dental phantom for digital image acquisition that complies with the IEC 61223-3-4:2000 standard.

  • Page 37: Cs 8200 3D Environmental Requirements

    CS 8200 3D 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 –...

  • Page 38: Cs 8200 3D Electrical Specifications

    CS 8200 3D 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 39 Accuracy of the Load Parameters High voltage kV ± 10 % Current in the tube mA ± 20 % Exposure time seconds Seconds ± (10 % + 1ms) or ± (5% + 50ms) Measurement Conditions Indirect on the peak kilovolt meter Direct measurement in the circuit using an oscilloscope Exposure time...

  • Page 40: 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 (0.07'') eq. Al Nominal value of the supplementary filtration at 70 2.5 mm (0.10’’) eq.
  • Page 41 Figure 3 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 42 Figure 4 Heating and Cooling Curves of the X-ray Tube Assembly Table 12 Beam Limitations of the X-ray Tube Assembly 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 140 mm panoramic mode at a distance of 563 mm from the At the detector reference plane...
  • Page 43 Table 13 Characteristics of the X-ray Tube Manufacturer’s name Toshiba or Canon Type OPX110 D-067 Nominal high voltage 110 kV 100 kV Nominal anode input 1755 W 1260 W power at 0.1 s (AC) Anode heat storage 30kJ 35 kJ capacity Nominal focal...
  • Page 44 Figure 8.2 X-ray tube drawing D-067 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02...
  • Page 45 Figure 9.1 Heating and Cooling Curves of the X-ray Tube OPX110 Figure 9.2 Heating and Cooling Curves of the X-ray Tube D-067 CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02...
  • Page 46 Figure 10.1 Single Load Chart of the X-ray Tube OPX110 Figure 10.2 Single Load Chart of the X-ray Tube D-067 CS 8200 3D Safety, Regulatory & Technical Specification (SMA67) Ed02...
  • Page 47 Figure 11.1 Filament Emissions of the X-ray Tube OPX110 Figure 11.2 Filament Emissions of the X-ray Tube D-067 CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02...

  • Page 48: Contact Information

    Samantha Bush Wiltron House, Rutherford Cl., Stevenage SG1 2EF, United Kingdom 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 49: List Of Importers For Switzerland

    List of Importers for Switzerland CURADEN AG Riedstrasse 12 CH-8953 Dietikon Switzerland Dema dent AG Furtbachstrasse 16 CH-8107 Buchs Switzerland Jordi Röntgentechnik AG Dammstrasse 70 CH-4142 Münchenstein Switzerland E. Schweizer AG Bernerstrasse Nord 182 CH-8064 Zürich Switzerland CS 8200 3D Safety, Regulatory & Technical Specifications (SMA67) Ed02...
  • Page 50 For more information visit: www.carestreamdental.com 2022-01 SMA67 Ed02...

Table of Contents

Save PDF