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iM3 REVOLUTION 4DC Manual

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97050901
REF 97050914
Rev. 00
17.02
EN

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  • Page 1 97050901 REF 97050914 Rev. 00 17.02...
  • Page 2 ITALIANO OPERATOR'S MANUAL...

  • Page 3: Table Of Contents

    Contents 1. GENERAL WARNINGS ............................. 5 1.1. SYMBOLS ................................5 1.2. STANDARDS AND REGULATIONS ........................6 1.3. INTENDED USE ..............................6 1.4. CLASSIFICATION ..............................6 1.5. ENVIRONMENTAL CONDITIONS ........................7 1.6. WARRANTY ................................. 7 1.7. PROTECTION AGAINST RADIATION ........................ 8 2.
  • Page 4 OPERATOR'S MANUAL...

  • Page 5: General Warnings

    1. GENERAL WARNINGS These instructions explain how to correctly use the REVOLUTION 4DC x-ray unit. Please carefully read this manual before using the device. NOTE: This manual does not specify all the obligations and warnings for possessing a source of ionising radiation as each country has its own laws.

  • Page 6: Standards And Regulations

    It is necessary to refer to the user manual. Pushing prohibited. Stepping prohibited. Ukrainian national symbol of conformity. UA.TR.101 1.2. STANDARDS AND REGULATIONS The system has been designed to meet the following standards: Directive 93/42/EEC and s.c. (dir. 2007/47/EC) - Medical Device Directive; Technical Standards: IEC 60601-1:2005 IEC 60601-1-2:2007...

  • Page 7: Environmental Conditions

    1.5. ENVIRONMENTAL CONDITIONS The equipment is to be installed in rooms that satisfy the following requirements: Temperature from +10 to +40° C. Relative humidity from 25 to 75% without condensate. Atmospheric pressure from 700 to 1060 hPa. The electrical wiring in the room in which the equipment is installed must conform to I.E.C. 60364-7-710;V2 specification (i.e.

  • Page 8: Protection Against Radiation

    1.7. PROTECTION AGAINST RADIATION PROTECTION AGAINST RADIATIONS. X-rays are hazardous and adequate precautions must be taken when using them. Areas where it is possible to be exposed to x-rays shall be clearly indicated by using this symbol, which should remind personnel to observe the safety rules laid down by the laws in force in the country where the equipment is used.

  • Page 9: Description Of The X-Ray Device

    2. DESCRIPTION OF THE X-RAY DEVICE The x-ray unit is available in several versions, which differ in type of installation, x-ray head and handheld. It is possible to identify the different versions via the REF on the nameplate. 2.1. INSTALLATION TYPE WALL-MOUNTED VERSION NOTE: This section applies only to models RX DC REF: I3PV****S (Character * can be any alphanumeric value)
  • Page 10 MOBILE STAND INSTALLATION NOTE: This section applies only to models RX DC REF: I3PV****M (Character * can be any alphanumeric value) c. X-ray generator. Constant potential high frequency x-ray generator. d. Removable collimator (cone). The generator can work with different types of collimator that are automatically recognised: 8”...
  • Page 11 To move the mobile stand x-ray unit: 1) Unplug the x-ray unit power cord from the power supply. 2) Place the power cord so that it does not get in the way. 3) Always secure the support arm with the associated safety belt. 4) Move the x-ray unit carefully using the handles.

  • Page 12: Type Of X-Ray Head

    2.2. TYPE OF X-RAY HEAD X-RAY HEAD WITH BALL JOINT NOTE: This section applies only to models RX DC REF: I3PV***** (Character * can be any alphanumeric value) The mechanical fitting with which the x-ray head is connected to the pantograph arm is a ball joint. The ball is provided with a mechanical brake to allow the x-ray head to maintain the position set by the operator.

  • Page 13: Switching On And Off The X-Ray Device

    3. SWITCHING ON AND OFF THE X-RAY DEVICE TURNING ON THE WALL-MOUNTED X-RAY UNIT NOTE: This section applies only to models RX DC REF: I3PV****S (Character * can be any alphanumeric value) The control unit is turned on and off from the main switch (A).

  • Page 14: Handheld Functions

    4. HANDHELD FUNCTIONS The handheld is turned on by pressing any key, except for the one for x-ray emission. A buzzer rings to confirm that the unit has been turned on. The unit will be in the standard configuration and it will start searching for the base it works with.

  • Page 15: Handheld Display Functions

    4.1. HANDHELD DISPLAY FUNCTIONS Field present for dialoguing with “base” Pause for cooling Handheld identification number Memorising Battery status Patient size selection 8” round collimator on (12” rectangular collimator not attached) Interlock active Graduated bar for thermal load Time/dose unit of measure Exposure time and dose display Tooth selection OPERATOR'S MANUAL...

  • Page 16: Use Of Handheld

    4.2. USE OF HANDHELD As illustrated in the figure below, the handheld has four function keys and a single x-ray emission key. “Dentition area selection” key “Body size selection” key X-ray emission light “Increase” key “Decrease” key “X-ray emission” key The main functions of the keys on the handheld, depending on how they are pressed, are: BRIEFLY PRESSED (less than 3 sec.).

  • Page 17: Checking The Parameters

    NOTE: The function related to pressing the key briefly is performed by pressing the key which will activate the function assigned to it. On the other hand, to perform the function carried out when the key is held down longer, press the key until the relative function is started. The buzzer will beep shortly to signal that the function has been activated.

  • Page 18: Factory Settings

    4.4. FACTORY SETTINGS REVOLUTION 4DC x-ray unit is supplied with the following factory settings: Operative mode: AUTO. Sensitivity: level 19. Handheld stand-by: 5 minutes Exposure times as per standard R'20: 0.020 - 0.022 - 0.025 - 0.028 - 0.032 - 0.036 - 0.040 - 0.045 - 0.050 - 0.056 - 0.063 - 0.071 - 0.080 - 0.090 - 0.100 - 0.110 - 0.125 - 0.140 - 0.160 - 0.180 - 0.200 - 0.220 - 0.250 - 0.280 -...

  • Page 19: Use Of The X-Ray Device

    5. USE OF THE X-RAY DEVICE 5.1. PATIENT POSITIONING A positioner or alignment device specific for the selected image receiver should always be used to assure the x-rays are correctly aligned regardless of the position the patient’s head is in. 5.2.

  • Page 20: Position Of The X-Ray Plate Or Sensor

    5.3. POSITION OF THE X-RAY PLATE OR SENSOR The parallel technique, where applicable, provides more accurate images in terms of size compared to the bisecting technique. A rectangular collimator, with 30 cm (12"), focus-skin distance, is always preferable to obtain better quality pictures.

  • Page 21: Setting The Exposure Mode And Time

    The x ray emission axis is perpendicular to the image receiver (for example a sensor or photostimulated phosphor plate) which in turn is parallel with the tooth’s long axis. As a result, the picture of the tooth will only be deformed by the divergence of the x rays in relation to the focus spot.
  • Page 22 WARNING: After customised settings have been made, the “Original exposure values charts” are no longer valid. If icon is displayed while the exposure time is changed, it means that the set time cannot be saved for the selected tooth-patient size combination. In any case, the x-rays can be taken with the set time. WARNING: When the suggested exposure time is changed, the sensitivity factor is also modified (by default set to F=19).

  • Page 23: Procedure To Be Followed When Taking The X-Ray

    5.5. PROCEDURE TO BE FOLLOWED WHEN TAKING THE X-RAY Pick up the handheld and move to a safe distance (at least 2 meters) maintaining visual contact with the patient and x-ray unit during the exposure. Make sure “ready” is indicated. Tell the patient to stay still.

  • Page 24: Advanced Options

    6. ADVANCED OPTIONS The handheld allows the user to view, edit and set some operating parameters by simply combining the keys provided. Follow the steps outlined below to access: KEY COMBINATION DESCRIPTION OF COMMAND Press these two keys to adjust the sensitivity levels (determined based on the table given below and type of sensor/receiver used), modifying the current value from the minimum to the maximum allowable one (on a scale from 3 to 25), with keys “+”...

  • Page 25: Setting The Operating Mode

    6.1. SETTING THE OPERATING MODE X-ray unit features the following operating modes: AUTO: the system automatically selects the best setting available for each tooth-patient size combination USER: the system automatically proposes the optimum exposure time according to the selected tooth and patient size - En65: all exposures are performed at 65KV and 6mA.

  • Page 26: Setting Type Of Movable Collimator

    6.2. SETTING TYPE OF MOVABLE COLLIMATOR X-ray unit features the following movable collimators: Rectangular 35x45 mm (only with ball joint) Round ø55 mm Rectangular 31x41 mm (to apply on round collimator ø55 mm) Rectangular 22x35 mm (to apply on round collimator ø55 mm) NOTE: For an ideal use of the x-ray unit, set the collimator depending on the type used.

  • Page 27: Error Messages

    7. ERROR MESSAGES ERROR CAUSE SOLUTION Hold down the key until the image has been X-RAY KEY RELEASED TOO EARLY captured. Handheld most likely lost the signal. Try to repeat SHOOTING SEQUENCE NOT COMPLETED exposure. If the problem persists, contact the technical service department.

  • Page 28: Periodic Maintenance

    8. PERIODIC MAINTENANCE WARNING: Any technical maintenance work required must be carried out by qualified personnel or by a specialised technician authorised by the manufacturer. It is the user’s responsibility to check that an authorised technician carries out routine maintenance at least every year. The maintenance methods are specified in the Technical Service Manual possessed by the Authorised Technicians For safety reasons and for the health of the patient, operator and third-parts inspections and maintenance must be carried out at regular intervals.

  • Page 29: Cleaning And Disinfection

    9. CLEANING AND DISINFECTION Cleaning is the first necessary step for any disinfection process. Rubbing with detergents and surfactants and rinsing with water removes allows removing a considerable number of microorganisms. If a surface is not cleaned first, the disinfection process cannot be successful. The x-ray unit can be a source of cross-contamination between patients.

  • Page 30: Disposing The Equipment When No Longer Used

    10. DISPOSING THE EQUIPMENT WHEN NO LONGER USED WARNING! Never remove the device covers. The device does not contain parts that can be repaired directly by the user. In the event of malfunctioning, do not attempt to carry out any type of maintenance operation. If you find or suspect any kind of system malfunctioning, do not attempt to carry out any type of maintenance operation and do not use the system on a patient, but directly contact your local distributor.

  • Page 31: Technical Data

    11. TECHNICAL DATA NOTE: This section applies only to models RX DC REF: I3PV*7*** (Character * can be any alphanumeric value) Specification for 70kV x-ray head: Rated voltage: 230-240 115-120 Vac (according to the model). Max. mains voltage fluctuation: ±10%. Rated current: 6A for the 230-240Vac version;...
  • Page 32 NOTE: This section applies only to models RX DC REF: I3PV*6*** (Character * can be any alphanumeric value) Specification for 65kV x-ray head: Rated voltage: 230-240 115-120 Vac (according to the model). Max. mains voltage fluctuation: ±10%. Rated current: 6A for the 230-240Vac version; 10A for the 115-120Vac version.

  • Page 33: X-Ray Tubes

    11.1. X-RAY TUBES X-RAY TUBE TOSHIBA D-041, TOSHIBA D-045, Kailong KL11-0,4-70 Anode inclination: 12.5° (with TOSHIBA D-041, TOSHIBA D-045) Anode inclination: 12° (with Kailong KL11-0,4-70) Anode thermal load: 4.3 KJ X-RAY TUBE CEI OX/70-3 Anode inclination: 13° Anode thermal load: 7 KJ Maximum continuous heat dissipation: 100 W.

  • Page 34: Technical Factor Measure

    X-RAY TUBE TOSHIBA D-0711, Kailong KL21-0,7. Anode inclination: 16.0° Anode thermal load: 7.0 KJ Maximum continuous heat dissipation: 170 W. Operating cycle: 1:60 (1 second exposure - 60 seconds pause time). COLLIMATOR TECHNICAL SPECIFICATIONS With rectangular collimator: SSD=30cm (12”), x-ray beam less than or equal to 45x35mm.

  • Page 35: Dimensional Characteristics

    12. DIMENSIONAL CHARACTERISTICS WALL-MOUNTED VERSION WITH BALL JOINT NOTE: This section applies only to models RX DC REF: I3PV****S (Character * can be any alphanumeric value) All dimensions are expressed in millimetres (inches). OPERATOR'S MANUAL...
  • Page 36 MOBILE STAND VERSION NOTE: This section applies only to models RX DC REF: I3PV****M (Character * can be any alphanumeric value) All dimensions are expressed in millimetres (inches). OPERATOR'S MANUAL...
  • Page 37 OPERATOR'S MANUAL...

  • Page 38: Identification Plates

    13. IDENTIFICATION PLATES WARNING: Never remove the identification nameplates provided on the generator, control unit and collimator cone. NOTE: This section applies only to models RX DC REF: I3PV****S (Character * can be any alphanumeric value) Control unit (MAIN NAMEPLATE). The nameplate is located beside the main switch Data given on plate: Name and address of the manufacturer.
  • Page 39 Collimator. The nameplate for the rectangular collimator is found outside it. Data given on plate: Name and address of the manufacturer. Equipment code. Technical data. DHHS compliance. Serial number. Month and year of manufacture. NOTE: This section applies only to models RX DC REF: I3PV***W* (Character * can be any alphanumeric value) Wireless handheld.

  • Page 40: Times/Sensitivity Charts

    14. TIMES/SENSITIVITY CHARTS When using the x-ray unit, in conjunction with Zen-X or X-Pod, it is recommended to use the default value of sensitivity. When using the x-ray unit, in conjunction with digital sensors (CMOS / CCD), phosphors or films, you need to find the appropriate exposure time in relation to the image that you want to obtain.

  • Page 41: Nominal Dose Emission Values

    15. NOMINAL DOSE EMISSION VALUES Dose in air @ 200 mm 60 kV 63 kV 65 kV 70 kV mGy/mAs (± 40%) 1.22 1.33 1.41 1.59 NOTE: This section applies only to models RX DC REF: *****6*** (Character * can be any alphanumeric value) Nominal emission values according to time and type of collimator: Collimator Round ø...
  • Page 42 NOTE: This section applies only to models RX DC REF: *****7*** (Character * can be any alphanumeric value) Nominal emission values according to time and type of collimator: Collimator Round ø 60 mm 200 mm A (cm 28.26 KV - mA 60kV 8mA 65kV 8mA 70kV 8mA...
  • Page 43 NOTE: This section applies only to models RX DC REF: *****6*** (Character * can be any alphanumeric value) Collimator Rectangular 35x45 mm 30 cm A (cm 15.75 KV - mA 60kV 7mA 63kV 6mA 65kV 6mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 44 NOTE: This section applies only to models RX DC REF: *****7*** (Character * can be any alphanumeric value) Collimator Rectangular 35x45 mm 30 cm A (cm 15.75 KV - mA 60kV 8mA 65kV 8mA 70kV 8mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 45 NOTE: This section applies only to models RX DC REF: *****6*** (Character * can be any alphanumeric value) Collimator Round ø 55 mm 30 cm A (cm 23.75 KV - mA 60kV 7mA 63kV 6mA 65kV 6mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 46 NOTE: This section applies only to models RX DC REF: *****7*** (Character * can be any alphanumeric value) Collimator Round ø 55 mm 30 cm A (cm 23.75 KV - mA 60kV 8mA 65kV 8mA 70kV 8mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 47 NOTE: This section applies only to models RX DC REF: *****6*** (Character * can be any alphanumeric value) Collimator Rectangular 22x35 mm 31 cm A (cm 7.70 KV - mA 60kV 7mA 63kV 6mA 65kV 6mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 48 NOTE: This section applies only to models RX DC REF: *****7*** (Character * can be any alphanumeric value) Collimator Rectangular 22x35 mm 31 cm A (cm 7.70 KV - mA 60kV 8mA 65kV 8mA 70kV 8mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 49 NOTE: This section applies only to models RX DC REF: *****6*** (Character * can be any alphanumeric value) Collimator Rectangular 31x41 mm 31 cm A (cm 12.71 KV - mA 60kV 7mA 63kV 6mA 65kV 6mA t (s) DOSE DOSE DOSE mGy ·...
  • Page 50 NOTE: This section applies only to models RX DC REF: *****7*** (Character * can be any alphanumeric value) Collimator Rectangular 31x41 mm 31 cm A (cm 12.71 KV - mA 60kV 8mA 65kV 8mA 70kV 8mA t (s) DOSE DOSE DOSE mGy ·...

  • Page 51: Inspection And Maintenance

    16. INSPECTION AND MAINTENANCE 16.1. USER INSPECTION These instructions describe the maintenance procedures for the x-ray unit. These instructions apply to all versions of said equipment, as well as all the accessories that may have been provided, therefore the description of some parts may not correspond to your equipment. Inspection and preventive maintenance must be performed at scheduled intervals to protect the health and safety of patients, users and other persons in accordance with national regulations regarding the use and maintenance of dental x-ray units that are in force in the country where the device is installed.

  • Page 52: Technical Maintenance

    16.2. TECHNICAL MAINTENANCE These instructions describe the maintenance procedures for the x-ray unit. These instructions apply to all versions of said equipment. In order to ensure the operational safety and functional reliability of the equipment installed, at least once a year an authorised service technician must perform a full inspection of the device. When taking measurements that require a multimeter, always use a calibrated digital multimeter.

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