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Summary of Contents for Carestream HEALTH CS 9000
- Page 1 CS 9000 Family: CS 9000, CS 9000 3D, CS 9000C, CS 9000C 3D Safety, Regulatory & Technical Specification 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 Health, Inc. U.S. Federal law restricts this device to sale by or on the order of a dentist or physician.
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Page 3: Table Of Contents
3 Technical Specification ............- 22 - Factory ........................- 22 - Model ......................... - 22 - CS 9000 Family Technical Specification ..............- 22 - Minimum Computer System Requirement ............. - 25 - X-Ray Dose Emission Information ................- 26 - Imaging Performance Information ................ -
Page 4: Safety Information
Safety Information Indications for Use The CS 9000 Family is intended to produce digital X-ray images and to be used at the direction of health care professionals of extra-oral dento-maxillofacial region of the human anatomy. The CS 9000 Family includes: CS 9000: panoramic modality •... -
Page 5: Note To The User
To use and operate your radiology unit and your digital imaging software you must follow the instructions contained in this guide. Warning and Safety Instructions When operating CS 9000 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 6 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 7: 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... - Page 8 5. Rinse thoroughly under running water for at least 1 minute to remove detergent residue. 6. Dry the accessory with compressed air or hygiene disposable cloth. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 9 4. Once sterilized, the accessory can be used immediately or stored dry and dust-free in its sterilization wrapping under temperature specified in section ‘‘CS 9000 Family Environmental Requirements’’ of the present guide. Cleaning and disinfecting the ear cones...
- Page 10 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 11 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 12: Marking And Labeling Symbols
Class 2 laser product. Maximum output power: 1 mW, 650 nm, IEC 60825-1 Ed.2 (2007) This unit emits laser radiation. The ON/OFF button Refer to instruction manual/booklet Non-ionizing radiation Manufactured Date Manufacturer’s address CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... -
Page 13: Label Locations
The following figure illustrates the label locations on CS 9000 and CS 9000 3D. Figure 1 CS 9000 and CS 9000 3D Unit Label Locations ** Only for USA. This warning also appears in the Parameter Pane of the Acquisition interface. - Page 14 Defines the unit’s model Defines the date that the unit was installed Conforms to all applicable standards under 21 CFR Defines the unit’s compliance with the US FDA chapter 1 subchapter J radiation standards CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 15: Regulatory Information
Medical Electrical Equipment - Part 1: General Requirements For Safety UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Safety Medical Electrical Equipment - Part 1: General Requirements For Safety EN/IEC 60601-1 and essential performance. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... - Page 16 Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). • The CS 9000 Family must be installed and put into service according to the EMC information provided in this document. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 17 CS 9000 Family. • The CS 9000 Family should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the CS 9000 Family should be observed to verify normal operation in the configuration in which it will be used.
- Page 18 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) The CS 9000 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9000 Family should assure that it is used in such an environment. Emissions Test...
- Page 19 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The CS 9000 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9000 Family should assure that it is used in such an environment. IEC 60601 Test...
- Page 20 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (IEC 60601-1-2) The CS 9000 Family is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 9000 Family should assure that it is used in such an environment. IEC 60601...
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Page 21: Compliance With International Regulations
Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the CS 9000 Family The CS 9000 Family is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the CS 9000 Family can help prevent... -
Page 22: Technical Specification
Factory TROPHY 4, rue F. Pelloutier, Croissy-Beaubourg 77435 Marne la Vallée Cedex 2, France Model CS 9000, CS 9000 3D, CS 9000C and CS 9000C 3D CS 9000 Family Technical Specification : CS 9000 Family Technical Specifications Table 3 Components... - Page 23 1158 (L) x 1595 (D) x 2378 (H)* mm Unit dimensions *Unit with 2225 mm (H) shorter column is also possible 1500 (L) x 2000 (D) x 2400 (H) mm Required space 160 kg (353 lb) Weight CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 24 2230 (L) x 2000 (D) x 2400 (H) mm Required space 39 kg (86 lb) Weight of only the cephalostat component 199 kg (437 lb 12 oz) Total weight with CS 9000 or CS 9000 3D CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 25: Minimum Computer System Requirement
A mouse with 2 buttons and a scroll A mouse with 2 buttons is required wheel is required Note: Always use Microsoft Windows Update to make sure that the latest security patches are correctly installed. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... -
Page 26: X-Ray Dose Emission Information
Two molar blocks Segmented Incisor Segmented Incisors + one molar block + TMJ Segmented one molar block + TMJ Segmented Two molar blocks + TMJ Maxillary sinus Lateral TMJ x2 Lateral TMJ x4 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... - Page 27 88.0 90.0 90.0 10.0 10.0 10.0 10.0 Patient Size Child Small Medium Large DAP in mGy.cm.cm* 205 x 205 205 x 274 274 x 274 274 x 300 300 x 300 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 28 274 x 300 300 x 300 3D patient dose information Table 9 68.0 70.0 70.0 74.0 10.0 10.0 Patient Size Child Small Medium Large DAP in mGy.cm.cm* One Volume Two Volume Three Volume CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 29 * This is the maximum value in the horizontal cross sectional plan with the chin rest. Other values in the vertical axis are lower than these values. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 30 * This is the maximum value in the horizontal cross sectional plan with the chin rest. Other values in the vertical axis are lower than these values. CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 31: Imaging Performance Information
The Signal-to-Noise Ratio (SNR) measured in an homogeneous 1 mm thick slice of PMMA* material is greater than 10. * Polymethyl methacrylate (PMMA) is a transparent thermoplastic material. Note: The CS 9000 family does not provide Computed Tomography (CT) numbers, therefore, conventional analyses using CT numbers cannot be made. -
Page 32: Cs 9000 Family Environmental Requirements
-10 - 60 °C Relative humidity 10 - 95% Atmospheric pressure 700 - 1060 hpa Transport Conditions Temperatures -10 - 60 °C Relative humidity 10 - 95% Atmospheric pressure 700 - 1060 hpa CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... -
Page 33: Cs 9000 Family Electrical Specifications
90 kV, 10 mA, 900 W time of 0.1 s Selection of the Load Parameters: kV (in increments of 1 kV) From 60 to 90 kV mA (in increments of 25%) From 2 to 15 mA CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... - Page 34 Seconds ±(10% + 1ms) or ±(5% + 50ms) 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 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 35: X-Ray Tube Assembly Technical Specifications
A lead collimator, which limits the size of the beam at the image receiver unit • A thermal cutout, which trips at an operating temperature between 63 to 70 °C (±5 °C) • CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04... - Page 36 Figure 4 Location of the Reference Axis for Panoramic Imaging Figure 5 Location of the Reference Axis for Cephalometric Imaging CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 37 Figure 6 Location of the Reference Axis for 3D Imaging CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 38 Anode ( 110kJ) Radiation leakage after one hour's operation < 1 mGy (maximum utilization rate of 33W) Weight 8.2 kg (18 lb 1 oz) Dimensions 235 x 245 x 120 mm CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 39 205 (±15) x 274 (±15) mm • (Cephalometric mode) 274 (±15) x 274 (±15) mm • 274 (±15) x 300 (±15) mm • 300 (±15) x 300 (±15) mm • At the detector reference plane CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 40 Nominal focal spot size (EN 60336) Tungsten Tungsten Tungsten Anode materials 5° 5° 5° Target angle 0.5 mm (0.020 ") eq. Al 0.8 mm (0.032") eq. Al 1,0 mm (0.04") eq. Al Inherent filtration CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 41 Figure 8 X-ray tube drawing: OPX 105 Figure 9 X-ray tube drawing: D-054 Figure 10 X-ray tube drawing: SR 90/15 FN CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 42 Figure 11 Heating and Cooling Curves of the X-ray Tube: OPX 105 Figure 12 Single Load Chart of the X-ray Tube: OPX 105 Figure 13 Filament Emissions of the X-ray Tube: OPX 105 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 43 Figure 14 Heating and Cooling Curves of the X-ray Tube: D-054 Figure 15 Single Load Chart of the X-ray Tube: D-054 Figure 16 Filament Emissions of the X-ray Tube: D-054 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
- Page 44 Figure 17 Heating and Cooling Curves of the X-ray Tube: SR 90/15 FN Figure 18 Single Load Chart of the X-ray Tube: SR 90/15 FN Figure 19 Filament Emissions of the X-ray Tube: SR 90/15 FN CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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Page 45: Contact Information
Representante no Brasil Carestream do Brasil Comércio e Serviços de Produtos Médicos Ltda. Rua Pequetita, 215 cjs. 31 E 32 Edifício Atrium VII - Vila Olímpia São Paulo - Brazil CEP (Zip code): 04552-060 CS 9000 Family Safety, Regulatory & Technical Specification (SM766)_Ed04...
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