Carestream CS 8100 3D User Manual
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Carestream CS 8100 3D User Manual

Cs 8100 3d family
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Safety, Regulatory and Technical Specifications User Guide

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Summary of Contents for Carestream CS 8100 3D

  • Page 1 Safety, Regulatory and Technical Specifications User Guide...
  • Page 2 3D full upper and lower jaw acquisition and to the cephalometric 26x24 FoV with licence upgrade. The CS 8100 3D and CS 8100 3D Access can be upgraded to Cephalometric modality, when the Scan Ceph module is provided as an upgrade kit.

  • Page 3: Table Of Contents

    Minimum Computer System Requirement ............... - 27 - X-ray Dose Emission Information ................- 28 - Panoramic mode for CS 8100 3D and CS 8100 3D Access ....... - 28 - 3D mode for CS 8100 3D and CS 8100 3D Access ........- 32 - Panoramic mode for CS 8100SC 3D and CS 8100SC 3D Access .....

  • Page 4: Safety Information

    3D full upper and lower jaw acquisition and to the cephalometric 26x24 FoV with license upgrade. The CS 8100 3D and CS 8100 3D Access can be upgraded to Cephalometric Modality, when the Scan Ceph module is provided as an upgrade kit.

  • Page 5: Conventions In This Guide

    CAUTION: Alerts you to a condition that might cause serious damage. Important: Alerts you to a condition that might cause problems. Note: Emphasizes important information. Tip: Provides extra information and hints. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 6: Note To The User

    To use and operate the unit you must follow the instructions contained in this guide. Warning and Safety Instructions When operating CS 8100 3D Family, observe the following warning and safety instructions: DANGER OF ELECTRIC SHOCK This is an electrical unit. Do NOT expose it to water spray. Such action may cause an electric shock or a malfunction of the unit.
  • Page 7 This unit is not intended for use with flammable anesthetics or flammable agents.  Do NOT hang from the cephalostat  It is not recommended to use accessories other than those specified in this document and sold by Carestream Health. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 8: Hygiene And Disinfection

    9. Visually inspect the unit for signs of deterioration. If any damage is noted, do not use the unit and contact a service technician. CAUTION Avoid applying any cleaning liquid to the inside parts of the unit. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 9 6. Dry the accessory with compressed air or hygiene disposable cloth. 7. Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 2 to 5, or safely dispose of the accessory. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 10 4. Once disinfected, the accessory can be used immediately or stored dry and dust-free in its sterilization wrapping under temperature specified in section ‘‘CS 8100 3D Family En- vironmental Requirements’’ of the present guide.
  • Page 11 5. Dry the accessory with compressed air or hygiene disposable cloth. 6. Visually inspect the accessory for residual soil. If soil is visible, either repeat steps 1 to 4, or safely dispose of the accessory. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 12 Local Authority that has claim for activity against hepatitis B after cleaning. The disinfectant’s manufacturer instructions for use must always be followed, especially with respect to contact time. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 13: Marking And Labeling Symbols

    WARNING Attention, consult Accompanying document IONIZING RADIATION symbol warn you about radiation dangers. The ON/OFF button. Refer to instruction manual/booklet Manufactured Date. Manufacturer’s address. Earth protection (ground). CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 14: Label Locations

    Label Locations CS 8100 3D and CS 8100 3D Access Labels The following figure illustrates the label locations of the CS 8100 3D and CS 8100 3D Access. Figure 1 CS 8100 3D and CS 8100 3D Access Label Locations...
  • Page 15 * Only for USA: This warning appears in the Parameter pane of the Acquisition interface. ** X-ray tube can be CEI OPX110 *** Canada specific labels **** Product label can be CS 8100SC 3D or CS 8100SC 3D Access CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 16 Only applicable for CS 8100SC 3D and computed tomography equipment under 21 CFR CS 8100SC 3D Access 1020.33, except with respect to those characteristics authorized by Variance Number FDA-2016-V-4097 effective December 23, 2016. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 17: Regulatory Information

    Medical Electrical Equipment - Part 1: General Requirements CAN/CSA C22.2 N°60601-1 For Safety and essential performance. Medical Electrical Equipment - Part 1: General Requirements ANSI/AAMI ES60601-1 For Safety and essential performance. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 18 Conformity with EN/IEC 60601-1-2 Group I, class B CS 8100 3D Family is intended to be used in a professional healthcare facility environment. Conformity with EN/IEC 60601-1-2 Electromagnetic Compatibility Precautions •...
  • Page 19 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The CS 8100 3D Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8100 3D Family should assure that it is used in such an environment.
  • Page 20 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 8100 3D Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8100 3D Family should assure that it is used in such an environment.
  • Page 21 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 8100 3D Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 8100 3D Family should assure that it is used in such an environment.
  • Page 22 The CS 8100 3D Family is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS 8100 3D Family can help prevent electromagnetic interference by maintaining a minimum distance between portable and...

  • Page 23: Compliance With International Regulations

     FDA Center for Devices & Radiological Health: CS 8100 3D: This product is in conformity with performance standards for diagnostic X-ray systems and their major components under 21 CFR 1020.30, and for computed tomography equipment under 21 CFR 1020.33, except with...

  • Page 24: Technical Specifications

    Tube focal spot 0.7 mm with X-ray tube OPX110 (IEC 60336) 0.6 mm with X-ray tube D-067 > 2.5 mm eq. Al Total filtration 90 kV Anode voltage 15 mA Cathode current CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 25 Volume Field Of 5 x 5 View (FOV) 8 x 5 (optional for CS 8100 3D Access and CS 8100SC 3D Access) diameter x height 8 x 8 (optional for CS 8100 3D Access and CS 8100SC 3D Access) (cm)
  • Page 26 Space Weight without the cephalostat 92 kg (202 lb) component Weight of only the cephalostat 30 kg (77 lb) components Total weight 95 kg (202 lb) 125 kg (280 lb) CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 27: Minimum Computer System Requirement

    * This must be the Ethernet board of the motherboard if the computer has several gigabit Ethernet boards. ** CS 8100 3D Family is not compatible with touch screen desktop Note: Always use Microsoft Windows Update to make sure that the latest security patches are correctly installed.

  • Page 28: X-Ray Dose Emission Information

    X-ray Dose Emission Information Panoramic mode for CS 8100 3D and CS 8100 3D Access Table 3 Dose information for Panoramic modality Patient size Radiological exam Area of interest Large Medium Small Child mGy.cm.cm DAP* in Incisors, molars and Full Panoramic...

  • Page 29: 3D Mode For Cs 8100 3D And Cs 8100 3D Access

    3D mode for CS 8100 3D and CS 8100 3D Access Table 4 Dose information for 3D modality Patient size Radiological exam Large Medium Small Child DAP* in mGy.cm.cm 1372 1097 8x 9 ** Fast One arch (Lower or Upper Jaw)
  • Page 30 ** 8 x 9 FoV: In Ontario (Canada), the use by dentists, of FOVs that are over 8 x 8, is subject to conditions. Note: The information in the table above may be subject to modi- fication. Without notice or justification to those concerned. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 31: Panoramic Mode For Cs 8100Sc 3D And Cs 8100Sc 3D Access

    *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. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 32: 3D Mode For Cs 8100Sc 3D And Cs 8100Sc 3D Access

    ** 8 x 9 FoV: In Ontario (Canada), the use by dentists, of FOVs that are over 8 x 8, is subject to conditions. Note: The information in the table aboves may be subject to modification. Without notice or justification to those concerned. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 33 ** 8 x 9 FoV: In Ontario (Canada), the use by dentists, of FOVs that are over 8 x 8, is subject to conditions. Note: The information in the table above may be subject to modification. Without notice or justification to those concerned. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 34: Cephalometric Mode For Cs 8100Sc 3D And Cs 8100Sc 3D Access

    *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 tables above may be subject to modification. Without notice or justification to those concerned. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 35 *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. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 36: User Dose Information

    Stray radiation is measured in full panoramic mode, for a large sized patient selected with a PMMA phantom cylinder (Ф 16 cm, h 15 cm) to simulate a patient head. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 37 < 1 µGy /h *This is the maximum value measured 20 cm above the horizontal cross sectional plane with a chin rest. Other values in the vertical axis are lower than these values. CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 38: Stray Radiation In 3D Mode

    Stray radiation is measured in largest 3D mode available, ie 8x9 mode, for a large sized patient selected with a PMMA phantom cylinder (Ф 16 cm, h 15 cm) to simulate a patient head. CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 39: Imaging Performance Information

    For optimum results, perform a control test of the image quality. To do this, see Controlling the Image Quality” chapter in the Panoramic and 3D Modality User Guide for CS 8100 3D Family, (SM842). CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...

  • Page 40: Cs 8100 3D Family Environmental Requirements

    10 – 90 % Atmospheric pressure 700 – 1060 hpa Transport Conditions Temperatures -10 – 60°C (14 – 140°F) Relative humidity 10 – 90 % Atmospheric pressure 700 – 1060 hpa CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 41: Cs 8100 3D Family Electrical Specifications

    - 85 kV, 5 mA - 13.9 second, every 3 example: one exposure - 80 kV, 15 mA - 13.9 minutes) second, every 3 minutes) 33 W 93 W CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 42 Measurement Conditions Indirect on the peak kilovolt meter Direct measurement in the circuit using an oscilloscope Exposure time Measurement at 75 % of the kV values with peak kilovolt meter CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 43: X-Ray Tube Assembly Technical Specifications

     Copper filter (for CS 8100 3D and CS 8100 3D Access) or Copper + Aluminum filter (for CS 8100SC 3D and CS 8100SC 3D Access), which enhances the quality of the beam and reduces the dose received by the patient ...
  • Page 44 Anode (110 kJ) Radiation leakage after one hour's operation < 1 mGy (maximum utilization rate of 33W) Weight 7 kg Dimensions 270 x 200 x 100 mm CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 45 1700 mm from At the detector reference plane the focal point Location of the reference axis See Figure 5 and Figure 6Location of the Reference Axis for Panoramic and 3D Imaging CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 46 Nominal focal spot 0.7 mm 0.6 mm size ( IEC 60336) Anode materials Tungsten Tungsten Target angle 12° 12° 0.8 mm (0.032’’) eq. Al Inherent filtration 0.5 mm (0.020 ") eq. Al CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 47 Figure 8.1 X-ray tube drawing OPX110 Figure 8.2 X-ray tube drawing D-067 CS 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 48 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 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...
  • Page 49 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 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 50 Figure 11.1 Filament Emissions of the X-ray Tube OPX110 Figure 11.2 Filament Emissions of the X-ray Tube D-067 CS 8100 3D Family Safety, Regulatory & Technical Specification (SM844)_Ed10...

  • Page 51: Contact Information

    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 8100 3D Family Safety, Regulatory & Technical Specifications (SM844)_Ed10...
  • Page 52 Carestream Dental A Division of Carestream Health, Inc. 150 Verona St. Rochester, NY 14608 For more information visit: www.carestreamdental.com ©Carestream Health, Inc., 2017. SM844 Ed10 2017-05...

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Cs 8100 3d accessCs 8100sc 3dCs 8100sc 3d access

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