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Carestream DENTAL Nanoray CS 2400P, Руководство пользователя

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Medical electrical equipment - Part 1-3: General 
requirements for basic safety and essential 
performance - Collateral Standard: Radiation 
protection in diagnostic X-ray equipment 

EN 60601-1-3 

Medical electrical equipment - Part 2-65: Particular 
requirements for the basic safety and essential 
performance of dental intra-oral X-ray equipment 

EN 60601-2-65 

2 

EMC 

Medical electrical equipment - Part 1-2: General 
requirements for basic safety and essential 
performance - Collateral Standard: Electromagnetic 
disturbances - Requirements and tests 

EN 60601-1-2

 

3 

Performance 

Medical electrical equipment -  Part 2-65: Particular 
requirements for the basic safety and essential 
performance of dental intra-oral X-ray equipment

 

EN 60601-2-65 

4 

Clinical 

Performance and 

Clinical Safety 

CLINICAL EVALUATION: 

A GUIDE FOR MANUFACTURERS AND NOTIFIED 
BODIES UNDER DIRECTIVES 93/42/EEC and 
90/385/EEC 

MEDDEV 2.7.1 

Rev 4 

•

References

-

PHE-CRCE-59: Dose to patients from dental radiographic X-ray imaging procedures

in the UK-2017 review, September 2020 Published by Public Health England (PHE)

-

X-Rays for Children: What Parents Should Know About Radiation Protection in

Medical Imaging by image gently.

-

Pediatric Information for X-ray  Imaging Device Premarket Notifications, Nov 28,

2017, Publicated by FDA (U.S. Food & Drug Administration.

Содержание Nanoray CS 2400P

Страница 1: ...Battery Free Portable Dental X ray USER MANUAL Doc UM 02FC 01 Rev 5 2021 01 29...

Страница 2: ...ned for future reference All instructions should be followed This appliance should not be used near water This appliance should be situated away from heat sources such as radiators heat registers stov...

Страница 3: ...ulating the wheel 26 4 3 Power ON OFF 26 4 4 Lock Unlock the X ray 26 4 5 Select teeth 26 4 6 Select Adult or child 26 4 7 Select film 27 4 8 LCD Liquid Crystal Display panel 27 4 9 Checking the remai...

Страница 4: ...on the part of the owner or operator 1 2 Owner and Operator s Obligations The owner of this equipment shall perform constancy tests at regular intervals in order to ensure patient and operator safety...

Страница 5: ...which through inappropriate conditions or actions may cause Severe personal injury to the operator and or patient Substantial property damage CAUTION Indicates that a potential hazard may exist which...

Страница 6: ...nufacture Main Label ISO 15223 Serial number Main Label ISO 15223 Catalogue number Main Label IEC60417 5031 Direct current Main Label ISO 7000 Small focal spot Main Label ISO15223 Temperature limit Ma...

Страница 7: ...ectrical safety regulations Main Label 2 Shipping Box symbol Mark Symbol Description Location ISO15223 Keep dry Box Label ISO7000 This side up Box Label ISO7000 Do not use if package is damaged Box La...

Страница 8: ...page 8 62 1 4 2 Labels and label positions Device labels 55x80mm NR F350 and CS 2400P...

Страница 9: ...page 9 62 Cradle Label 45 X 30mm External exposure switch Label 45 X 30mm Optional not delivered in the generator kit...

Страница 10: ...page 10 62 Adaptor Label 38 X 90mm Warning Label 50 X 20mm...

Страница 11: ...page 11 62 Caution Label 60 X 20mm...

Страница 12: ...agnostic X ray systems and their major components under 21 CFR 1020 30 and performance standards for ionizing radiation emitting products 21 CFR 1020 31 Classifications IEC60601 1 6 1 Protection again...

Страница 13: ...duct should be taken by qualified service personnel according to procedures and preventive maintenance schedules Always turn off the product before cleaning The device uses beam limiting device rectan...

Страница 14: ...azard e g noises from the product itself As the charger must be located and used at place where users can easily connect and disconnect it to the power supply Keep the charger in place to use at the e...

Страница 15: ...romagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation WARNING Portable RF communications equipment including peripherals such as antenna cables...

Страница 16: ...nts 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 Pregnant women should not be exposed to X rays un...

Страница 17: ...ake the super capacitor wet or let it be in water Keep super capacitor clean and dry Keep the super capacitor away from children and pets Seek medical advice immediately if the super capacitor has bee...

Страница 18: ...nd in house radiation protection program in regard to patients and operators who are pregnant or expect to become pregnant 4 Operators must be fully acquainted with industry safety recommendations and...

Страница 19: ...t is perpendicular to the operator with the patient s head tilted if needed and the backscatter shield is fully extended toward the patient and parallel to the operator 10 Operation outside the protec...

Страница 20: ...nual Operator Exposures Occupational Dose limit1 500 mSv Occupational Dose limit Required Dosimetry1 50 mSv Average Exposure Using The Portable Dental X ray Model CS 2400P with D Speed Film2 0 32 mSv...

Страница 21: ...tage generator and the generated X rays are irradiated to the teeth of the human body 3 3 Intended User Profile Considerations Requirement Description Education Licensed dentist or dental hygiene radi...

Страница 22: ...ponents No Item Standard Option Qty 1 CS 2400P Main Body 1 2 User Manual 1 3 Cradle power cord included 1 4 Rectangular Cover 2x3 1 5 Rectangular Cover 4x3 1 6 Back scatter shield Ring 1 7 External ex...

Страница 23: ...Output Current 3 3A Maximum Power 60W Approved by IEC 60601 1 3 Power cord set Plug Type HG TR Model NEMA 5 15 HOSPITALGRADE Rated current and voltage 15 A 125 V AC Cord Type SJT3X16AWG Dielectric st...

Страница 24: ...tton Turns the product on off 6 Cone cover Can replaced with rectangular cover 7 Back scatter shield Shield scattered X ray from patient 8 X ray collimator Cone Limits X ray exposure area 9 Exposure b...

Страница 25: ...ck button at least one second to lock on Press the lock unlock button at least four seconds to lock off Press the button to turn mode the system Press the Enter button at least six second to setting m...

Страница 26: ...4 4 Lock Unlock the X ray The X ray lock and unlock functionality can be activated to prevent unauthorized use when the device is idle This functionality may also be used for training purposes To loc...

Страница 27: ...nel No ICON Description 1 Requires the user to pay attention such as charging or waiting 2 Being charged 3 X ray is being exposed 4 Super capacitor indicator 5 Waiting time for retaking an X ray 6 Adu...

Страница 28: ...isor in sequence 4 9 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...

Страница 29: ...he current status of the system charge exposure battery level exposure object selection mode exposure time and Charge state tooth selection 3 5 inch Out size dimension 64 X 46mm Viewing Area Dimension...

Страница 30: ...initialization Initialize by Administrator mode 9 Exposure Display x ray exposure status 10 Exposure limit When performing other functions it should not be exposed even though the exposure switch is p...

Страница 31: ...randomly changed exposure time 2 Once the button is pressed it changes to the standby screen 3 Use the wheel to operate the value that you want to change in each exposure mode 4 S mode is maintained e...

Страница 32: ...ed CS 2400P will require authorized service E62 Trigger the exposure switch When the exposing button shtus down abnormally The LOC message is displayed on the lcd screen and is released using the ligh...

Страница 33: ...degrees If you want to change direction you can turn it in any direction Step 1 Step 2 Step 3 Step 4 1 Do not use the charger in humid conditions 2 Do not use the charger if it has a damaged plug 3 D...

Страница 34: ...cleaning the product turn off the power and disconnect the charging cradle and the charger from the power When cleaning the surfaces make sure that the equipment is not connected to the cradle The pro...

Страница 35: ...hat the equipment is clean and ready for use Daily After using the equipment make sure that the equipment has been turned off Daily Wipe the outer covers of the equipment with a dry cloth at the end o...

Страница 36: ...page 36 62 If any defects are found do not operate the equipment since it has to be handled by a qualified person Contact your Service Representative...

Страница 37: ...d Paper X ray tube Battery super capacitor Other parts This symbol on the product and or accompanying documents means that used electrical and electronic equipment WEEE should not be mixed with genera...

Страница 38: ...sion mm 270 9 L x 267 7 H x 143 3 W Weight kg 2 3 10 Charging Cradle Dimension mm 226 L x 159 6 H x 30 W Weight kg 0 55 10 X ray Beam Limiting Device X ray Beam Area mm Round Type FOV 60 Rectangular T...

Страница 39: ...Exposure time range sec 0 06 1 00 sec 5 Measuring efficiency kV 10 sec 5 mA 20 Display LCD Panel Display 3 0 Inch BTN LCD 1 4Duty 1 3BIAS X ray Tube Model KL11 0 4 70 Kailong Inherent Filtration Min 0...

Страница 40: ...Type Inverter Type Tube Voltage 65 75kV Tube Current 2 8 4 2 mA X ray Tube Manufacturer Hangzhou Kailong Medical Instrument Co Ltd Model KL 11 0 4 70 Focal spot size 0 4 mm IEC 60336 Anode heat conten...

Страница 41: ...m rating chart Emission characteristics Heating and cooling curves of X ray tube Tube Dimensions mm 4 Battery Item Description Type Super Capacitor Nominal Capacity 100 F Nominal Voltage 3 0 V d c 5 b...

Страница 42: ...requency 50 60 Hz Standard IEC 60601 1 UL Power Cord 250 V 16 A Power cord set Plug Item Description Model NEMA 5 15 HOSPITALGRADE Type HG TR Manufacturer Feller Rated current and voltage 15 A 125 V A...

Страница 43: ...0 s 5 or 20ms Rated Voltage 14 5 V d c 7 4 Environmental Specifications Item Description During operating Temperature 10 35 Relative humidity 30 75 Atmospheric pressure 860 1060 hPa Transport and stor...

Страница 44: ...able for reference Patient Teeth Angle of inclination SSD 200mm 8 inch kV mA sec Adult DR Incisor Maxilla 45 Mandible 25 70 3 5 0 15 Canine Maxilla 45 Mandible 20 70 3 5 0 18 Upper Molar Maxilla 30 70...

Страница 45: ...5 0 50 FL Incisor Maxilla 45 Mandible 25 70 3 5 0 33 Canine Maxilla 45 Mandible 20 70 3 5 0 39 Upper Molar Maxilla 30 70 3 5 0 50 Lower Molar Mandible 5 70 3 5 0 45 Bitewing 5 8 70 3 5 0 65 8 2 X ray...

Страница 46: ...est Equipment Instrument Manufact urer Model S N Dose Meter Ray safe X2 Base Unit 225575 Dose Table 70 kVp 3 5 mA FOV 6 cm SSD 200 mm at Al 6 mm t s Dose Gy 0 06 41 0 10 68 0 14 95 0 20 134 0 34 221 0...

Страница 47: ...easured with each cover type default rectangular 2x3 and rectangular 4x3 all the results have been ND Not Detected The raw data about the results is shown in the table below exposure time 160 ms ND No...

Страница 48: ...ime tables were established with a unit equipped with a cone that corresponds to a focus to skin distance of 200 mm 8 inch respectively Method PMMA Phantom aligned to 280 mm away from Focal Spot with...

Страница 49: ...e 49 62 Vertical Plane With Backscatter shield Direction Result R s 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 9 5 270 2 3 290 9 8 315 28 3 335 32...

Страница 50: ...Class B The CS 2400P model device user RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Har...

Страница 51: ...eration during power mains interruptions it is recommended that the CS 2400P model device be powered from an uninterruptible power supply or a battery Voltage interruptions IEC 61000 4 11 0 UT 250 300...

Страница 52: ...midity should be at least 30 Radiated RF EM fields IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Professional healthcare facility environment 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz Home health...

Страница 53: ...s between portable and mobile RF communications equipment and the CS 2400P model device The CS 2400P model device is intended for use in an electromagnetic environment in which radiated RF disturbance...

Страница 54: ...ge FOV Field of View IEC International Electro technical Commission ISO International Standards Organization LED Light Emitting Diode ME Medical Electrical PMMA PolyMethylMethAcrylate RF Radio Frequen...

Страница 55: ...ry 0 04 mSv 4 days Chest X ray single 0 01 mSv 1 day The FDA s Center for Devices and Radiological Health defines the age range of the pediatric population as birth through 21 years While the risk of...

Страница 56: ...and name of disease No Contents Description 1 Indications for producing diagnostic dental radiographs for treatment of diseases of the teeth jaw and other oral structures using intra oral image recep...

Страница 57: ...as possible Doctors balance the benefit of the test and potential small risks of x ray tests Your doctor and the radiologist x ray doctor will work together to decide which test is best for your child...

Страница 58: ...0 33 Canine Maxilla 45 Mandible 20 70 3 5 0 39 Upper Molar Maxilla 30 70 3 5 0 50 Lower Molar Mandible 5 70 3 5 0 45 Bitewing 5 8 70 3 5 0 65 Use of equipment and exposure settings designed for an ave...

Страница 59: ...Gy 0 06 41 0 10 68 0 14 95 0 20 134 0 34 221 0 5 320 0 6 377 0 8 487 1 0 595 Table below is information about used equipment for test Test Equipment Instrument Manufact urer Model S N Dose Meter Ray s...

Страница 60: ...mode If this image appears on the display it is child mode In child mode quantities of exposure dose are reduced to 60 compared to adult mode Essential Performance No Essential performance Description...

Страница 61: ...2 3 Performance Medical electrical equipment Part 2 65 Particular requirements for the basic safety and essential performance of dental intra oral X ray equipment EN 60601 2 65 4 Clinical Performance...

Страница 62: ...anufactured by NANORAY Co Ltd NANORAY Co Ltd 401 402 403 408 409 76 Dongnae ro Dong gu Daegu Republic of Korea CALMED INVEST Kft HU11678179 Attila utca 34 Budapest 1191 Hungary Tel 36 1 291 5066 Fax 3...

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