Carestream DENTAL Nanoray CS 2400P User Manual
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Carestream DENTAL Nanoray CS 2400P User Manual

Battery-free portable dental x-ray
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Battery-Free
Portable Dental X-ray
USER MANUAL
Doc. UM-02FC-01
(Rev.5, 2021.01.29)

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Summary of Contents for Carestream DENTAL Nanoray CS 2400P

  • Page 1 Battery-Free Portable Dental X-ray USER MANUAL Doc. UM-02FC-01 (Rev.5, 2021.01.29)

  • Page 2: Notice

    U.S. patents issued : 10,881,364 B2 DISCLAIMER: The Carestream Dental and CS 2400P logos are trademarks of Carestream Dental LLC. Nanoray and NP-350E are trademarks of Nanoray Co., Ltd. worldwide. All other brand and product names are trademarks or registered trademarks of their respective companies.

  • Page 3: Table Of Contents

    Table of Contents Notice .............................. 2 Table of Contents ..........................3 General and Regulatory Information ....................4 Manufacturer's Liability .................... 4 Owner and Operator's Obligations ................4 Conventions Used in this Manual ................5 Marks and Symbols ....................6 Standards and Regulations ..................12 Recommendation for an efficient operation .............

  • Page 4: General And Regulatory Information

    General and Regulatory Information Manufacturer's Liability The manufacturers and/or retailers of this equipment assume responsibility for the safe and normal operation of this product only when:  Genuine NANORAY approved equipment and components have been used at all times.  All maintenance and repairs have been performed by NANORAY authorized agent.

  • Page 5: Conventions Used In This Manual

    Conventions Used in this Manual The following symbols are used throughout this manual. Make sure that you fully understand each symbol and follow the instructions which accompany it. To prevent personal injury and/or damage to the equipment, please observe all warnings and safety information included in this document.

  • Page 6: Marks And Symbols

    Marks and Symbols 1.4.1 The following table describes the purpose and location of safety symbols and other important information provided on the equipment. 1) Device symbol Mark/Symbol Description Location Battery Charger Alternate current Label ISO 15223 Manufacturer Main Label ISO 15223 Date of manufacture Main Label ISO 15223 Serial number Main Label...
  • Page 7 ISO 7010 Refer to instruction manual/booklet. Main Label ISO15223 Authorized representative in the Main Label European Community CSA mark of conformity showing compliance with applicable Canadian Main Label electrical safety regulations. 2) Shipping Box symbol Mark/Symbol Description Location ISO15223 Keep dry Box Label ISO7000 This side up Box Label...
  • Page 8 1.4.2 Labels and label positions Device labels (55x80mm): NR-F350 and CS 2400P page 8 / 62...
  • Page 9 Cradle Label (45 X 30mm) External exposure switch Label (45 X 30mm) (Optional – not delivered in the generator kit) page 9 / 62...
  • Page 10 Adaptor Label (38 X 90mm) Warning Label (50 X 20mm) page 10 / 62...
  • Page 11 Caution Label (60 X 20mm) page 11 / 62...

  • Page 12: Standards And Regulations

    Standards and Regulations Standards: The CS 2400P is designed and manufactured to meet the following standards:  IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-1-3, IEC/EN 60601-2-65  IEC 60601-2-65:2012 Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment ...

  • Page 13: Safety Instructions

    Safety Instructions General Safety Guidelines 1) General Safety Guidelines - This product requires a longer break time than the exposure time after an X-ray exposure. The minimum duty cycle rating (the relationship between duration and frequency of exposures) is 1:90. Duration 0.06s 0.32s...

  • Page 14: Warnings And Safety Instructions

    Warnings and Safety Instructions This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. It is important to read this user manual carefully and strictly abide by all warnings and cautions stated within it. To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth.
  • Page 15 Especially for pregnant women, it is recommended to use personal dosimetry and a lead apron - The vertical significant zone of occupancy measures 60 cm X 200 cm, while the horizontal significant zone of occupancy is 60 cm X 60 cm. - The Backscatter Shield : In addition to the radiation shielded cone, the back scatter shield provides additional protection to the operator.
  • Page 16 This equipment should be operated in the area that is more than 6 feet away from other personnel, such as assistants or other patients. If they should stay closer than 6 feet, it is recommended that they wear a lead apron, thyroid collar, or stay behind a lead shield.

  • Page 17: Using Super Capacitor

    Using Super Capacitor - Make sure to charge the super capacitor in the external environment from the patient. - Make sure to use the super capacitor only provided or approved by NANORAY. If non- standard or damaged super capacitors are used, there is risk of fire and explosion. - Make sure to use the cradle only provided or approved by NANORAY.

  • Page 18: Radiation Safety

    Radiation Safety • This X-ray device may be dangerous to operator, patient and bystander unless safe exposure factors, operating instructions and maintenance schedules are observed. • Do not operate if the backscatter shield or collimator cone are broken. Ensure proper registration and compliance with any such regulation. In implementing a radiation protection program, please consult any state, provincial, and local regulations governing radiation protection and the use of X-ray equipment.
  • Page 19 are positioned and ready for the exposure, reducing the likelihood of interruption and preventing inadvertent exposure of anyone to X-rays. Do not attempt an exposure if anyone else is positioned immediately behind the patient (in line with the direction of X-ray emission). If others are assisting, then they should wear protective covering.

  • Page 20: System Overview

    Average Exposure Using The Portable Dental X-ray (Model: CS 0.03 mSv 2400P) with D-Speed Film Average Exposure Using The Portable Dental X-ray (Model: CS 0.05 mSv 2400P) with F-Speed Film or Digital Sensor 1) Standards for Protection Against Radiation, 10 CFR 20 (US Federal Standards), 1994 2) NCRP Report No.

  • Page 21: Indications For Use

    only to trained and qualified dentist or dental technician. Indications for Use The Portable Dental X-Ray (Model: CS 2400P) is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

  • Page 22: Patient Population And Name Of Disease

    Patient population and name of disease Contents Description for producing diagnostic dental radiographs for treatment of Indications diseases of the teeth, jaw, and other oral structures using intra- oral image receptors. Not limited Weight Not limited No limit but patients must wear lead aprons during their X-ray Health imaging.

  • Page 23: General View Of The Equipment

    General view of the equipment 3.7.1 Components and Accessories 1) Components Figure Name Specifications 1) Model: NP-350E / CS 2400P 2) Rated Input power: DC 14.5V 3.33A 3) Rated output power: 245W 4) Display: LCD Panel Display Main Body (3.5 Inch, BTN LCD, 1/4Duty, 1/3BIAS) 5) X-ray Tube: (1) Model: KL11 -0.4-70 (Kailong) (2) Inherent Filtration:...
  • Page 24 3.7.2 Name of each parts Item Description Indicates status of the product wheel Changes the X-ray exposure time Enter button Select a setup mode Mode-changing buttons Changes the X-ray exposure mode Power on/off button Turns the product on/off Cone cover Can replaced with rectangular cover Back scatter shield Shield scattered X-ray from patient...

  • Page 25: Instructions For Use

    Instructions for Use The frequently used functions Scroll the wheel button to select the number. Press the power button at least one second to turn on. Press the button to turn Press the power button at least four seconds to turn off on/off the system.

  • Page 26: Change Exposure Time By Manipulating The Wheel

    Change exposure time by manipulating the wheel - Scroll through the wheel to manipulate exposure time from 0.06s ~ 1.00s. - Scroll: Rolling the wheel up and down. Power ON/OFF - Press the button at least one second to turn on. - Press the button at least four second to turn off..

  • Page 27: Select Film

    Select film - Press the button to select DR, CR, Film. LCD(Liquid Crystal Display) panel ICON Description Requires the user to pay attention such as charging or waiting. Being charged. X-ray is being exposed. Super capacitor indicator. Waiting time for retaking an X-ray Adult or child Exposure time and charging status : being charged,...

  • Page 28: Checking The Remaining Charge In Super Capacitor

    (bitewing) Selected teeth (press button) Bitewing → Mandible molar → Maxillary molar → Canine → Incisor in sequence Checking the remaining charge in Super Capacitor -Make sure that at least one battery indicator light comes on. 0-25% remaining 25-50% remaining 50-75% remaining 75-100% remaining 4.10...

  • Page 29: Interfaces Between The Software System And Other Systems

    4.11 Interfaces between the software system and other systems User Interface Function Interface specification - Program start, end - Teeth selection - Select the exposure object - Select the type of exposure - Initialize exposure time - Administrator mode entry and exit 6ea button (Beside LCD Button - Change administrator mode...
  • Page 30 Contents Function Bitewing mode Mandible molar mode Teeth selection mode Maxillary molar mode Canine mode Incisor mode Exposure object Adult mode selection mode Child mode DR mode Exposure type selection CR mode mode Film mode Display exposure time (0.06 ~ 1.00 sec) Exposure time mode Selecting the Exposure time within the settable range of each mode...

  • Page 31: Exposure Times Auto-Save Mode / Reset Exposure Time

    4.13 Exposure times Auto-save mode / Reset exposure time ● When initially used, exposure times will operate at the default value when power is cycled. ● When Auto-save mode of exposure time (1) When you press the button(at one second) to blink an adult or a child, scroll the wheel down so that the mode indicator is "...

  • Page 32: Troubleshooting

    4.14 Troubleshooting Error Code Potential Problem Corrective Action CS 2400P will require authorized (Tube current If it is lower than the set tube current service. under) (Generator High Generator high voltage cable not CS 2400P will require authorized voltage cable connected service.

  • Page 33: Change The Cone Circle To Rectangular Cover

    Do not use the charger in humid conditions. Do not use the charger if it has a damaged plug. Do not use the charger after it has been dropped or damaged Do not open / disassemble the charger. Do not use the charger in direct sunlight Do not charge in the environment with patient.

  • Page 34: Maintenance

    Maintenance Storage Avoid placing the product, the charger and the charging cradle in places, unlikely to have any issues/damages due to temperature/humidity, direct sunlight, dust and salinity. Keep the charger and the charging cradle disconnected from the power supply when the product is not used for a long period of time Avoid keeping the product near chemical or gas storage facilities Cleaning When cleaning the product, turn off the power and disconnect the charging...

  • Page 35: Maintenance

    5.3 Maintenance NANORAY requires periodic constancy tests to ensure image quality and the safety for the patient and operator. Only NANORAY authorized technicians can perform inspection and service of this equipment. For the technical assistance, contact NANORAY service center or your local NANORAY representative.
  • Page 36 If any defects are found, do not operate the equipment since it has to be handled by a qualified person. Contact your Service Representative. page 36 / 62...

  • Page 37: Disposing Of The Unit

    Disposing of the Unit In order to reduce environmental contamination, this equipment is designed to be as safe as possible to use and dispose of. Many components of this equipment are environment- friendly and can be recycled. All parts and components that contain hazardous materials must be disposed of in accordance with disposal regulations.

  • Page 38: Product Specifications

    Product Specifications Mechanical Specifications Dimensions Item Description 270.9(L) x 267.7(H) x Dimension (mm) 143.3(W) Main Body Weight (kg) 2.3 (± 10 %) Dimension (mm) 226(L) x 159.6(H) x 30(W) Charging Cradle Weight (kg) 0.55 (± 10 %) Round Type FOV: < ø 60 X-ray X-ray Beam Beam...

  • Page 39: Technical Specifications

    Technical Specifications 1) Portable dental X-ray Items Specifications Model Name NP-350E / CS 2400P Device DC 18V 3.33A Rated Input power Adaptor 100-240 VAC, 50-60Hz 1.4-0.7A Rated output power 245W Internal Power 14.5 VDC (Super capacitor), 10EA kV/mA 70 kV /3.5 mA Exposure time range [sec] 0.06 - 1.00 sec ±5% ±10%...
  • Page 40 2) X-ray Generator Item Specifications Model NRF-350-G1 Rated output power Max. 0.21 kW 1:90 Duty Cycle (Exposure time: Interval time) High Voltage Thermistor ≥ 70 °C Cooling Protection Generator (Assembly) Type Inverter Type Tube Voltage 65-75kV Tube Current 2.8 - 4.2 mA Manufacturer Hangzhou Kailong Medical Instrument Co., Ltd...
  • Page 41 3) X-ray Tube Characteristics ① ② Maximum rating chart Emission characteristics ③ ④ Heating and cooling curves of X-ray Tube Dimensions [mm] tube 4) Battery Item Description Type Super Capacitor Nominal Capacity 100 F Nominal Voltage 3.0 V d.c. 5 by 2 Charging Voltage 14.5 V d.c.
  • Page 42 5) Adaptor & Power cord set Adaptor Item Description Model GSM60A18 Manufacturer MEAN WELL Input: 100 - 240 V~, 50 - 60 Hz, 1.4-0.7A Rating Output: 18 V DC., 3.33 A Frequency 50 - 60 Hz Standard IEC 60601-1 (UL) Power Cord 250 V~, 16 A Power cord set(Plug)

  • Page 43: Electrical Specifications

    30 ~ 75 % Atmospheric pressure 860 ~ 1060 hPa -10 ~ 60 ℃ Temperature Transport and storage Relative humidity 10 ~ 75 % non-condensing Atmospheric pressure 860 ~ 1060 hPa page 43 / 62 Carestream Dental - Unrestricted Internal Use...

  • Page 44: Appendix

    8. Appendix Tables of Exposure Times (Default) The following exposure time tables were established with a unit equipped with a cone that corresponds to a focus-to-skin distance of 200 mm (8 inch) respectively. We can use it with DR, CR, Film type detectors, the exposure Times according to the type are as follow table. The table below shows the exposure time recommended by the manufacturer.

  • Page 45: X-Ray Dose Data

    SSD: 200mm(8 inch) Angle of Patient Teeth inclination Maxilla : +45˚ Incisor 0.10 Mandible : -25˚ Maxilla : +45˚ Canine 0.12 Mandible : -20˚ Upper Maxilla : +30˚ 0.15 Molar Lower Mandible : -5˚ 0.14 Molar Bitewing +5˚ ~ +8˚ 0.19 Maxilla : +45˚...
  • Page 46 X-ray Dose Table Test Equipment Instrument Manufact Model urer Dose Meter Ray-safe X2 Base Unit 225575 Dose Table (70 kVp, 3.5 mA, FOV: Ø 6 cm, SSD 200 mm, at Al 6 mm) Dose (μGy) t (s) 0.06 0.10 0.14 0.20 0.34 page 46 / 62...
  • Page 47 Leakage Dose Scope IEC 60601-2-65 203.12.4 Requirements In the LOADING STATE, the AIR KERMA due to LEAKAGE RADIATION from X-RAY SOURCE ASSEMBLIES, 1 m from the FOCAL SPOT, average over any area of 100 cm of which no principal linear dimension exceeds 20 cm, when operated at the NOMINAL X-RAY TUBE VOLTAGE under condition of LOADING corresponding to the reference LOADING conditions, shall not exceed 0.25 mGy in one hour.
  • Page 48 Scattered Dose Scope IEC 60601-2-65 203.12.2 Requirements ME EQUIPMENT shall be provided with means to optionally allow actuation of the IRRADAIATION from a PROTECTED AREA after installation. Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS. Results The following exposure time tables were established with a unit equipped with a cone that corresponds to a focus-to-skin distance of 200 mm (8 inch) respectively.
  • Page 49 Vertical Plane, With Backscatter shield Result [μR/s] Direction [°] 0 ° 32.1 20 ° 15.7 45 ° 23.5 65 ° 26.5 90 ° 56.6 110 ° 24.3 135 ° 24.7 155 ° 18.1 180 ° 30.7 200 ° 33.8 225 ° 29.8 245 °...

  • Page 50: Electromagnetic Compatibility (Emc) Information

    Electromagnetic Compatibility (EMC) Information Guidance and manufacturer’s declaration - electromagnetic emissions - The unit meets the collateral standards of electromagnetic compatibility – Requirements and tests EN 60601-1:2017, IEC 60601-1-2:2014 the limits and methods of measurements of electromagnetic disturbance characteristics of industrial, scientific and medical radio frequency equipment CISPR 11 Group 1, Class B medical electrical equipment is subject in regard to the electromagnetic compatibility (EMC) and its special precautionary measure.
  • Page 51 100 kHz repetition frequency Mains power quality should be ± 0.5 kV, ± 1.0 kV Line-to-line Surge that of a typical commercial or ± 1.0 kV, ± 2.0 kV Line-to-ground IEC 61000-4-5 hospital environment. 0 % UT, 0,5 cycle, At 0°, 45°, 90°, Mains power quality should be 135°, 180°, 225°, 270°...
  • Page 52 Guidance and manufacturer’s declaration - electromagnetic immunity The CS 2400P model device is intended for use in the electromagnetic environment specified below. The customer or the user of the CS 2400P model device should assure that it is used in such an environment IMMUNITY test IEC 60601-1-2 test level...
  • Page 53 Note 1 : At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TB broadcast cannot be predicted theoretically with accuracy.

  • Page 54: 8.4 Abbreviations

    8.4 Abbreviations Name Acronym Aluminum Electromagnetic Compatibility Electrostatic Discharge Field of View International Electro technical Commission International Standards Organization Light-Emitting Diode Medical Electrical PMMA PolyMethylMethAcrylate Radio Frequency Source to Image receptor Distance Signal Input Part Signal Output Part Source to Skin Distance page 54 / 62...

  • Page 55: X-Ray For Pediatric Patients

    X-ray for Pediatric patients • Risk of the Pediatric patients We all are exposed to small amounts of radiation daily from the sun, soil, rocks, buildings, air and water. People living in the mountains or flying in planes are exposed to higher amounts of radiation than those living near sea level.
  • Page 56 The operator must have understood: treatment and diagnosis of dental disease  Knowledge terms and guidance of diagnostic medical radiation devices  device connection, installation and operating conditions.  The operator must have understood: Language the English or Korean manuals (or other languages ...
  • Page 57 Before use the Portable Dental X-ray to the pediatric patients, Please press the child button on the device. (In child mode, exposure dose of Portable Dental X-ray (CS 2400P) reduced 60% compared to the adults based on the literature) Label Position The amount of radiation from an x-ray is very small.
  • Page 58 - Shield patients when possible - Repeat images only when necessary • Tables of Exposure Times for children SSD: 200mm(8 inch) Angle of Patient Teeth inclination Maxilla : +45˚ Incisor 0.10 Mandible : -25˚ Maxilla : +45˚ Canine 0.12 Mandible : -20˚ Upper Maxilla : +30˚...
  • Page 59 (CS 2400P) reduced 60% compared to the adults based on the literature. National DRLs have been typically set at a rounded 75th percentile of the dose distribution. The values presented in Table are proposed as new NDRLs for the UK. X-ray type Patient size Proposed NDRL...
  • Page 60 respectively. The main purpose of our product (CS 2400P) is intra-oral radiograph we choose the ratio 0.6 (60%) of adult for child. In addition, the dose of DR/CR/Film in the mandibular molar region of children was measured as 0.19/0.48/0.59mGy, respectively, and was lower than 0.42/0.48/0.6mGy, which is 60% of the adult value in the 50th percentile in Table 4 of the NDRL report.
  • Page 61 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation EN 60601-1-3 protection in diagnostic X-ray equipment Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential EN 60601-2-65 performance of dental intra-oral X-ray equipment Medical electrical equipment - Part 1-2: General requirements for basic safety and essential...
  • Page 62 Manufactured by NANORAY Co., Ltd. NANORAY Co., Ltd. #401,#402,#403,#408,#409, Dongnae-ro, Dong-gu, Daegu, Republic of Korea CALMED INVEST Kft. (HU11678179) Attila utca 34., Budapest, 1191, Hungary Tel)+36-1+291-5066 Fax)+36-1-291-0366 page 62 / 62...

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