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Villa Sistemi Medicali ROTOGRAPH-D User Manual

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ROTOGRAPH- - - - D D D D
ROTOGRAPH
ROTOGRAPH
ROTOGRAPH
Release 15 July 2011 (Rev. 1)
(120V version)
(120V version)
(120V version)
(120V version)
User's manual
User's manual
User's manual
User's manual

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  • Page 1 ROTOGRAPH ROTOGRAPH ROTOGRAPH ROTOGRAPH- - - - D D D D (120V version) (120V version) (120V version) (120V version) User's manual User's manual User's manual User's manual Release 15 July 2011 (Rev. 1)
  • Page 2 USER'S MANUAL Revision history Revision history Revision history Revision history Revision history Rev. Date Page/s Modification description 26.10.05 Document approval. 15.07.11 Release version Restyle 2011. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 3 USER'S MANUAL Revision history THIS PAGE IS INTENTIONALLY LEFT BLANK ROTOGRAPH-D (120V) (Rev. 1)

  • Page 4: Table Of Contents

    6.3.1.4 Performing the exposure (refer to Figure 7)......32 6.3.2 Performing the TMJ2 examination ............. 33 6.3.2.1 Preparing the equipment ............33 6.3.2.2 Preparing the patient (refer to Figure 5) ........ 34 6.3.2.3 Performing the exposure (refer to Figure 7)......36 (Rev. 1) ROTOGRAPH-D (120V)
  • Page 5 Defects due to wrong setting of radiological data and dark room..43 MAINTENANCE This publication can only be reproduced, transmitted, transcribed, or translated into any human or computer language with the written consent of Villa Sistemi Medicali S.p.A. This manual in English is the original version. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 6: Introduction

    QuickVision manufactured by Owandy. ROTOGRAPH-D is available in a single version for the execution of: • PANORAMIC examination •...

  • Page 7: Safety Information

    X-ray generators. Villa Sistemi Medicali shall not be responsible for: • any use of ROTOGRAPH-D different from that for which it has been designed, • any damage to the equipment, the operator or the patient caused either by incorrect installation and maintenance not compliant with the procedures contained in the relevant user’s and installation...

  • Page 8: Warnings

    3 meters away from ROTOGRAPH-D and be powered via an independent electric line. ROTOGRAPH-D must be switched off during the entire period of use of ESU (Electro Surgery Units) units or similar equipment.
  • Page 9 6.6 feet (2 meters) from both the radiation source and patient. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 10: Environmental Risk And Disposal

    • Column, rotating arm, extensions: iron, lead, aluminum, copper, non-biodegradable plastic materials, glass resin. NOTE: Disassembling part of the unit must be performed by Villa Sistemi Medicali personnel or by authorized technical people. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 11: Symbols Used

    Connection to neutral conductor Connection to line conductor Protection ground Functional ground OFF ; equipment not connected to power line     ON ; equipment connected to power line Warning: read the documentation provided with the unit ROTOGRAPH-D (120V) (Rev. 1)

  • Page 12: Cleaning And Disinfecting Procedures

    The chin support, the patient positioning handles and the temple-clamp must be carefully cleaned and disinfected with a 2% Glutharaldeid solution or similar (find out what is available; e.g. Milton) after each examination where they have been used. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 13: Description

    USER'S MANUAL Description 4. 4. 4. 4. DESCRIPTION DESCRIPTION DESCRIPTION DESCRIPTION Identification labels Identification labels Identification labels Identification labels ROTOGRAPH-D (120V) (Rev. 1)
  • Page 14 USER'S MANUAL Description ROTOGRAPH-D WARNING label ETL certification label label Tube head Digital Sensor identification label identification label Laser WARNING Remote control label identification label (Rev. 1) ROTOGRAPH-D (120V)

  • Page 15: Description

    (please refer to the specific chapter of this manual). ROTOGRAPH-D is controlled by a soft touch console and equipped with an alphanumeric digital display for a clear indication of the working parameters and operative messages. The operative cycle is entirely run...

  • Page 16: Technical Features

    TECHNICAL FEATURES TECHNICAL FEATURES TECHNICAL FEATURES TECHNICAL FEATURES General characteristics Equipment ROTOGRAPH-D Manufacturer VILLA SISTEMI MEDICALI Buccinasco (MI) Italy Class Class II according to 21 CFR sub-chapter J. Class I with type B applied parts according to IEC. Degree of protection IP20 120V ±...
  • Page 17 USER'S MANUAL Technical features Tubehead features Type MR05 Manufacturer VILLA SISTEMI MEDICALI Buccinasco (MI) Italy Max peak tube potential 85 kV Nominal power 0.630 kW (85kVp, 10mA) Total filtration ≥ 2.8mm Al eq. at 85 kV Insulation Oil bath Cooling...
  • Page 18 30% ÷ 75% Operating relative humidity range -4°F ÷ +158°F (-20° ÷ +70°C) Transportation and storage temperature range Maximum transportation and storage < 90% non condensing relative humidity Minimum atmospheric pressure for 630 hPa transportation and storage (Rev. 1) ROTOGRAPH-D (120V)

  • Page 19: Standards And Regulation

    USER'S MANUAL Technical features Standards and regulation Standards and regulation Standards and regulation Standards and regulation The ROTOGRAPH-D equipment is manufactured according to the following standards: 21 CFR subchapter J • General safety: IEC 60601-1 IEC 60601-1-1 IEC 60601-2-7 IEC 60601-2-28...

  • Page 20: X-Ray Tubehead Curves

    Tube "CEI - - - - O O O OPX/105" (0.5x0.5) Tube "CEI PX/105" (0.5x0.5) Tube "CEI Tube "CEI PX/105" (0.5x0.5) PX/105" (0.5x0.5) Loading chard Anode cooling chard (Rev. 1) ROTOGRAPH-D (120V)
  • Page 21 USER'S MANUAL Technical features Cooling curve of tubehead E(KJ) m in ROTOGRAPH-D (120V) (Rev. 1)

  • Page 22: Technical Factors Measuring Method

    VDC 20V, 1V=1mA). The exposure times are determined by using a timer/counter, having an accuracy of 0.1%, measuring the duration of part of the voltage applied to the primary side of the tubehead, during the exposure phase. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 23: Overall Dimension

    USER'S MANUAL Technical features Overall dimension Overall dimension Overall dimension Overall dimension 406 (16") 897 (35.3") 1256 (50") 774 (30.5") 1170 (46") Figure 1: ROTOGRAPH-D overall dimension ROTOGRAPH-D (120V) (Rev. 1)

  • Page 24: Operating Instructions

    2. The system sets for: • ADULT with push button "33" LED lighted up • MEDIUM SIZE with push button "36" LED lighted up • Display (44) shows the kV alternatively to the exposure times. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 25: Panoramic X-Ray Examination

    CONSISTENT WITH THE SELECTION DONE WITH THE BUTTONS POSITIONED IN THE AREA OF THE DIGITAL SENSOR. After completing the system SET UP, adjust the chin support as follows: Chin support Chin support PANORAMIC (1) SINUS (21) ADULT PANORAMIC CHILD ROTOGRAPH-D (120V) (Rev. 1)

  • Page 26: Programmed/Manual Exposure

    The following table shows the programmed values according to the selection made: Large Size Medium Size Small Size (35) (36) (37) Adult (33) 80kV - 17sec 70kV - 17sec 65kV - 17sec Child (34) 65kV - 14sec 60kV - 14sec 60kV - 14sec (Rev. 1) ROTOGRAPH-D (120V)

  • Page 27: Manual Exposure (Refer To Figure 7)

    If, after having reached the minimum or maximum values of the kV range additional decrease or increase is requested, the following messages will be displayed: Minimum or Maximum; the minimum or maximum set kV values will subsequently be displayed. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 28: Preparing The Patient (Refer To Figure 2 And Figure 3)

    8. Check centring again, advise the patient to close mouth and eyes, ask then to swallow and bring the tongue against the palate and remain motionless for the exposure. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 29 USER'S MANUAL Operating instructions Figure 2: Panoramic position Legend of reference lines: 45 – Sagittal median line 46 – Frankfurt plane line Figure 3 ROTOGRAPH-D (120V) (Rev. 1)

  • Page 30: Making The Exposure (Refer To Figure 7)

    "Wait, please .." indicating a waiting time of 4 minutes to allow cooling of the tubehead anode. NOTE: After each examination, clean carefully both chin support and temples- clamp and replace the bite. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 31 If, for external reasons or incorrect operation the X-ray emission times should exceed 17 seconds, a backup security timer will come into operation cutting out the emission after 20 seconds, the arm rotation will continue until the natural stop point. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 32: Tmj Examination

    (TMJ1) or open (TMJ2) mouth. With TMJ1 projection the lateral portions of the image are generated, while the centre part will be generated with the TMJ2 projection. We suggest to follow the sequence TMJ1 and TMJ2. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 33: Performing The Tmj1 Examination

    The equipment preparation has to be completed removing the chin’s support for standard panoramic (1 - Figure 7) and replacing it with the one for sinuses’ examination (21 - Figure 7). Chin support Chin support PANORAMIC (1) SINUS (21) ADULT CHILD ROTOGRAPH-D (120V) (Rev. 1)

  • Page 34: Programmed/Manual Exposure

    The times reported in the previous table are the sum of the exposure time for the right condyle with the one of the left condyle, while the arm rotation time remains the same as the one reported for the panoramic examination. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 35: Preparing The Patient (Refer To Figure 4)

    (7), by acting on the appropriate knob (9). This will help the patient to hold the correct position during the examination. ROTOGRAPH-D (120V) (Rev. 1)
  • Page 36 USER'S MANUAL Operating instructions Figure 4: TMJ1 position (Rev. 1) ROTOGRAPH-D (120V)

  • Page 37: Performing The Exposure (Refer To Figure 7)

    "Press Reset" will appear. The return button (32) is, then, to be pressed to bring the machine in the starting position. The return end is evidenced by the message "OK" which will disappear when the button (32) is released. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 38: Performing The Tmj2 Examination

    POSITIONED IN THE AREA OF THE DIGITAL SENSOR. NOTE: Operator has to evaluate the needs to increase the kV selection of one step; from some clinical results; this will increase image’s quality. Eventually, use a manual programming mode. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 39: Preparing The Patient (Refer To Figure 5)

    (7), by acting on the appropriate knob (9). This will help the patient to hold the correct position during the examination. ROTOGRAPH-D (120V) (Rev. 1)
  • Page 40 USER'S MANUAL Operating instructions Figure 5: TMJ2 position (Rev. 1) ROTOGRAPH-D (120V)

  • Page 41: Performing The Exposure (Refer To Figure 7)

    In the event that the patient will move during TMJ2 exposure and after TMJ1 mode already executed, it is mandatory to repeat also TMJ1 exposures to have the complete result of TMJ1 and TMJ2 on the same image. ROTOGRAPH-D (120V) (Rev. 1)
  • Page 42 LED of the last examination performed will light on. NOTE: If for external reasons or incorrect operation the emission times should exceed 5 seconds, a safety backup timer intervention will come into operation, interrupting emission but the arm rotation will continue until the end. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 43 To change from the programmed function to the manual one and viceversa, proceed as described at point 6.2.2 bearing in mind that the kV and Time (seconds) parameters in Sinus exposure are like the Panoramic ones. ROTOGRAPH-D (120V) (Rev. 1)
  • Page 44 3. Proceed operating as for points 6.2.3. steps 5, 6, 7 and 8. Figure 6: SINUS position 6.4.4 6.4.4 6.4.4 6.4.4 Performing the exposure Performing the exposure Performing the exposure Performing the exposure Proceed as for point 6.2.4, following the relevant notes. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 45: Messages On Display (Refer To Figure 6 And Figure 7)

    Messages on display Messages on display Figure 8) ROTOGRAPH-D is entirely controlled by a microprocessor that, besides controlling the emission parameters and the line voltage fluctuation, indicates the different equipment's operating modes by means of appropriated messages on display (44), the eventual anomalies and mistakes.
  • Page 46 (1) If line voltage is outside the specified range ( 10%), contact the local power company in order to take the necessary corrective actions. Villa Sistemi Medicali will not bear any cost for proper line set-up. (Rev. 1) ROTOGRAPH-D (120V)

  • Page 47: Identification And Correction Of Defects In Dental Radiographs Exposure

    Upper apical zone too dense Upper apical zone too dense Upper apical zone too dense The patient is not keeping his lips tightly together and is not holding the tongue against the palate. Corrective action: See point 6.2.3. step 8. ROTOGRAPH-D (120V) (Rev. 1)

  • Page 48: Defects Due To Wrong Setting Of Radiological Data And Dark Room

    Completely white image It has not been exposed to X-rays or digital sensor borken. Corrective action: Verify the X-rays emission by checking light and acoustic signal (light 43 Figure 8), If the defect persists call for Technical Assistance. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 49 USER'S MANUAL Operating instructions THIS PAGE IS INTENTIONALLY LEFT BLANK ROTOGRAPH-D (120V) (Rev. 1)
  • Page 50 Skull / Temple clamp control knob Patient positioning handle and slider Motor group unit Support unit of the motor group Slider Brake release button PAN selection button Slot for Memory Card TMJ1 selection button Focus position point TMJ2 selection button (Rev. 1) ROTOGRAPH-D (120V)
  • Page 51 TMJ2 mode Selection Push-button Multifunctional Test mode ("dead man" button) Decrease kV RESET ("dead man" button) Increase kV Adult Selection X-rays push-button ("dead man" button) Child Selection X-rays emission pilot LED Large Size Selection Alphanumeric display (Rev. 1) ROTOGRAPH-D (120V)

  • Page 52: Maintenance

    Every 6 months check that the label are not damaged and well attached. WARNING: If any of the above checks give negative results, the operator must contact the authorized service personnel. (Rev. 1) ROTOGRAPH-D (120V)
  • Page 53 USER'S MANUAL MAINTENANCE LOG-BOOK This log-book has to be filled in by the authorized Villa Sistemi Medicali engineer after installation and after performing the preventive or corrective maintenance visits. Installation: Date ... Technician ....Maintenance: Date ..... Technician ....Cause ..........
  • Page 54 Final test table Final test table This table is reserved to Qualified and Trained Service Technician Data setted on Hand Control for ROTOGRAPH-D S.N......... Voltage supply for rotation motor A1 V1 ..R39 A1 V1 ..R40 Decelerating ramp for Central OPG R41 ..
  • Page 55 USER'S MANUAL THIS PAGE IS INTENTIONALLY LEFT BLANK ROTOGRAPH-D (120V) (Rev. 1)
  • Page 56 Cod. 6908917700_Rev.1 VILLA SISTEMI MEDICALI S.p.a. Via Delle Azalee, 3 20090 Buccinasco (MI) - ITALY Tel. (+39) 02 48859.1 Fax (+39) 02 4881844...

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