EN
       Sophie Classic S
     user's manual
                          20006413_2
                                                                                                                    TABLE OF CONTENTS
1    INTRODUCTION ..............................................................................................1
2    SYMBOLS ........................................................................................................2
3    CHECKLIST BEFORE OPERATION ...............................................................3
4    SOPHIE CLASSIC S - MAIN PARTS ...............................................................4
     4.1    General view of Sophie Classic S .................................................................................. 4
     4.2    Exposure button ............................................................................................................. 5
     4.3    Compression paddles .................................................................................................... 5
     4.4    Buckys ........................................................................................................................... 5
     4.5    Open cassette holder and magnification platform (magnification views only) (optional) 6
     4.6    Foot controls with five switches (optional) ..................................................................... 6
     4.7    Rhodium filter (optional) ................................................................................................. 6
     4.8    Detachable film markers (optional) ................................................................................ 7
     4.9    Chin guard ..................................................................................................................... 7
     4.10   CR interface adapter (optional) ...................................................................................... 7
5    SWITCHING THE X-RAY UNIT ON .................................................................8
6    CONTROLS ......................................................................................................9
     6.1    C-arm controls ............................................................................................................... 9
     6.2    Foot controls (standard) ................................................................................................. 9
     6.3    Foot controls with five switches (optional) ................................................................... 10
     6.4    Exposure control .......................................................................................................... 11
     6.5    Emergency stop button ................................................................................................ 11
7    MAIN CONTROL PANEL ...............................................................................12
8    PREPARING THE X-RAY UNIT .....................................................................19
     8.1    Attaching and removing the Bucky .............................................................................. 19
     8.2    Attaching and removing the compression paddle ........................................................ 20
     8.3    Attaching and removing the open cassette holder and the magnification platform
            (optional) ...................................................................................................................... 21
     8.4    Automatic paddle release ............................................................................................ 22
     8.5    Adjusting the film density ............................................................................................. 22
9    CONTACT VIEW PROCEDURE ....................................................................23
     9.1    Loading the cassette .................................................................................................... 23
     9.2    Setting the exposure values ......................................................................................... 23
     9.3    Height adjustment ........................................................................................................ 24
     9.4    Radiation level selection .............................................................................................. 24
     9.5    Normal view selection .................................................................................................. 24
     9.6    Three-second view selection ....................................................................................... 28
10   BREAST COMPRESSION AND TAKING EXPOSURES ..............................29
     10.1   Breast compression ..................................................................................................... 29
     10.2   Emergency compression release ................................................................................. 30
     10.3   Taking an exposure ..................................................................................................... 31
     10.4   After exposure .............................................................................................................. 32
11   MAGNIFICATION PROCEDURES (OPTIONAL) ...........................................33
     11.1 Magnification procedure with standard compression paddle ....................................... 33
     11.2 Magnification procedure with spot paddle .................................................................... 34
12   BIOPSY PROCEDURES (OPTIONAL) ..........................................................35
User’s Manual                                                                                               Planmed Sophie Classic S i
TABLE OF CONTENTS
     12.1 Biopsy procedure with perforated biopsy paddle ......................................................... 35
     12.2 Biopsy procedure with rectangular biopsy paddle ....................................................... 36
13   MANUAL EXPOSURE PROCEDURE ...........................................................37
14   SPECIAL FUNCTIONS ..................................................................................38
     14.1 Automatic kV selection in AEC mode .......................................................................... 38
     14.2 Selecting the AEC mode .............................................................................................. 38
     14.3 Setting the oblique view angle ..................................................................................... 39
     14.4 Posterior-anterior viewing angle .................................................................................. 40
     14.5 Setting the speed of the compression paddle movement ............................................ 40
     14.6 Adjusting the initial speed at which the C-arm moves up and down ............................ 41
     14.7 Setting the stop limit of the compression force ............................................................ 42
     14.8 Adjusting the volume of the exposure warning signal .................................................. 42
     14.9 Contrast/dose adjustment ............................................................................................ 43
     14.10Setting the correct time and date ................................................................................. 43
     14.11Density offset adjustment ............................................................................................. 44
     14.12Disabling Bucky grid movement ................................................................................... 44
     14.13mA limit (on/off) ............................................................................................................ 45
15   TRANSPORTING THE X-RAY UNIT .............................................................46
     15.1 Preparing the X-ray unit for transportation ................................................................... 46
     15.2 Setting up the X-ray unit after transportation ............................................................... 47
16   HELP MESSAGES .........................................................................................49
17   ERRORS AND ERROR MESSAGES ............................................................51
18   MAINTENANCE .............................................................................................57
     18.1 Daily check ................................................................................................................... 57
     18.2 Cleaning ....................................................................................................................... 57
     18.3 Servicing ...................................................................................................................... 57
19   DISPOSAL OF THE X-RAY UNIT ..................................................................58
20   TECHNICAL SPECIFICATIONS ....................................................................59
21   LOCATION OF EQUIPMENT LABELS AND WARNING TEXTS .................61
                       The manufacturer, assembler, and importer are responsible for the safety, reliability and
                       performance of the unit only if:
                       - installation, calibration, modification and repairs are carried out by qualified author-
                       ized personnel
                       - electrical installations are carried out according to the appropriate requirements such
                       as IEC 60364
                       - equipment is used according to the operating instructions
                       Planmed pursues a policy of continual product development. Although every effort is
                       made to produce up-to-date product documentation this publication should not be
                       regarded as an infallible guide to current specifications. We reserve the right to make
                       changes without prior notice.
                       COPYRIGHT PLANMED
                       Released: 10 December 2009
                       PUBLICATION PART NUMBER 20006413 revision 2
ii Planmed Sophie Classic S                                                                                                       User’s Manual
                                                                                                              INTRODUCTION
                                      1   INTRODUCTION
                                                                        This manual describes how to set up and use the
                                                                        Sophie Classic S mammography X-ray unit. This X-ray
                                                                        unit must only be used for mammography.
                                                                  NOTE The use of Sophie Classic S mammography X-
                                                                       ray unit is allowed only under supervision of a
                                                                       health care professional.
                                                                        The Planmed Sophie Classic S mammography X-ray
                                                                        unit fulfills the requirements of European Council
                                                                        Directive 93/42/EEC, Class IIB.
                                                                  NOTE This manual is valid for the following software
                                                                       revisions:
                                                                       - REAR12 CPU 1.16 or later
                                                                       - TUBE CPU 3.42 or later.
                                                                        All key illustrations indicate that the key should be
OBL
 LAT
                  CC
                         OBL
                          LAT
                           DEX
                                                            CTL         pressed, or where indicated, pressed and held down.
  SIN
                                                                        Pressing a key will switch a function on or off
                               kV
      kV
                                mAs
       mAs
                                                                        depending on the original setting. When a function is
           CTL
                 3 2 1
                                                                        on, or activated, the key indicator light will either come
                                                                        on or start to flash.
                                                                        The display values in this guide are only examples and
                                                            26          should not be interpreted as recommended values
                                                                        unless otherwise stated.
                                                                  NOTE This manual includes also description of
                                                                       optional items that vary from market to
                                                                       market.
                                                                  NOTE Make sure that the C-arm locking knob has
                                      Base
                                                                       been removed from the X-ray unit’s base. If
                                                 Locking               not, remove it by turning it counterclockwise.
                                                 knob
                                                                  NOTE EMC requirements have to be considered, and
                                                                       the equipment must be installed and put into
                                                                       service according to the specific EMC
                                                                       information provided in the accompanying
                                                                       documents.
                                                           CAUTION The    Planmed     Sophie  Classic   S
                                                                   mammography X-ray unit is not suitable
                                                                   for use in the presence of a flammable
                                                                   anaesthetic mixture with air or with
                                                                   oxygen or nitrous oxide.
  User’s Manual                                                                                  Planmed Sophie Classic S 1
SYMBOLS
           Potential adverse events
                                            The potential adverse effects apply to mammography
                                            with the Planmed Sophie Classic S X-ray unit:
                                            •   Excessive breast compression
                                            •   Excessive X-ray exposure
                                            •   Electric shock
                                            •   Infection
                                            •   Skin irritation, abrasions, or puncture wounds.
      2    SYMBOLS
                                            Type B equipment (Standard IEC 60601-1).
                                            Alternating current (Standard IEC-60417).
                                            Attention,   consult    accompanying         documents
                                            (Standard IEC 60601-1).
                                            Electrostatic sensitive device (Standard IEC 60417).
                                            Separate collection for electrical and electronic
                                            equipment according to Directive 2002/96/EC
                                            (WEEE).
           Notes, Cautions, and Warnings
                                      NOTE Note messages are used to indicate
                                           information which may be helpful or of special
                                           interest to the reader.
                               CAUTION Caution statements alert the user to the
                                       possibility of a problem with the X-ray unit
                                       associated with its use or misuse. Such
                                       problems include X-ray unit malfunction,
                                       X-ray unit failure, damage to the X-ray unit
                                       or damage to other property.
                                            WARNING
                                            Warning statements alert the user to
                                            the possibility of personal injury to the
                                            user or the patient, or other serious
                                            damage associated with the use or
                                            misuse of the X-ray unit.
2   Planmed Sophie Classic S                                                           User’s Manual
                                                   CHECKLIST BEFORE OPERATION
     3     CHECKLIST BEFORE OPERATION
                                 WARNING
                                 It is very important that the place
                                 where the X-ray unit is to be used and
                                 the position from which the user is to
                                 operate the X-ray unit are correctly
                                 shielded. Since radiation safety
                                 requirements vary from country to
                                 country and state to state it is the
                                 responsibility of the user to ensure
                                 that all local safety requirements are
                                 met.
                         NOTE Electromagnetic interference between the
                              equipment and other devices can occur in
                              very extreme conditions. Do not use the
                              equipment in close conjunction with sensitive
                              devices,   or    devices    creating    high
                              electromagnetic disturbances.
                             •   Make sure that you are fully acquainted with the
                                 appropriate radiation protection measures and these
                                 operating instructions before using the X-ray unit.
                             •   The X-ray unit is designed to operate using a line
                                 voltage of between 187 and 265 V~ (50/60Hz) and a
                                 line current of 15A. If the X-ray unit is being used in a
                                 new location for the first time check that the power
                                 supply you intend to use is suitable for the X-ray unit.
                             •   Make sure that the exposure switch is installed behind
                                 a radiation protection shield.
                             •   Always use fresh film. Store and handle the film
                                 according to the manufacturer’s instructions.
                             •   Make sure that the film and screen are compatible.
                             •   Use only daylight (DIN) cassettes dedicated for
                                 mammography.
                             •   Make sure that the intensifying screen is clean and
                                 free from dust. Clean the screen at the beginning of
                                 each working session.
                             •   Make sure that the film processor is correctly set up for
                                 processing mammography films.
                             •   Film viewing facilities should be available on site so
                                 that the radiographs can be examined. Make sure that
                                 the illumination level of the viewing equipment being
                                 used meets the film manufacturer’s recommendations.
User’s Manual                                             Planmed Sophie Classic S 3
SOPHIE CLASSIC S - MAIN PARTS
      4      SOPHIE CLASSIC S - MAIN PARTS
                                                                                               NOTE This section also includes description of
                                                                                                    optional items that vary from market to
                                                                                                    market. Contact your sales representative for
                                                                                                    further information.
      4.1                   General view of Sophie Classic S
                                                                                                                  Tubehead assembly
                                                                                                                  C-arm controls
                                                                                                                  Hand rail
                                                                                                                                             C-arm
                                                                                                                  Chin guard
                                                                                                                  Compression paddle
                                                                                                                  Bucky
                                                                                                                  C-arm controls
                                                                                                                  Main control panel
                                                            Sophie_classic_main_parts001.eps
                                                                                                                  Telescopic column
                                                                                                                                             Column
                                                                                                                  Fixed column
                                                                                                                          Base display
                                CR
                                   Inte
                                                          Base
                                                                                                                     Foot controls
                                       rfac
                                            e   Ada
                                                   pte
                                                      r
              Exp
                    Sw
                         itch
                                X-ray
                                        Unit
            CR interface
            adapter (optional)
4   Planmed Sophie Classic S                                                                                                             User’s Manual
                                                                SOPHIE CLASSIC S - MAIN PARTS
     4.2        Exposure button
                                                                            Exposure button
                                               OR
                            Exposure button
     4.3        Compression paddles
  18 cm x 24 cm                       24 cm x 30 cm                        3” spot paddle
  compression paddle                  compression paddle
                    Perforated biopsy paddle         Rectangular hole biopsy paddle
     4.4        Buckys
                    18 cm x 24 cm Bucky for             24 cm x 30 cm Bucky for
                    Sophie Classic S                    Sophie Classic S
User’s Manual                                                          Planmed Sophie Classic S 5
SOPHIE CLASSIC S - MAIN PARTS
      4.5    Open cassette holder and magnification platform
             (magnification views only) (optional)
                18 cm x 24 cm open cassette holder
                for Sophie Classic S
                                                                    Magnification platform
      4.6    Foot controls with five switches
             (optional)
      4.7    Rhodium filter (optional)
                                                     As an option to the automatic selection between
                                                     aluminium and molybdenum filters (standard), Sophie
                                                     Classic S may be equipped with the automatic
                                                     selection of rhodium and molybdenum filters, in which
                                                     case the rhodium filter replaces the aluminium filter.
                                          NOTE The filters are installed at the factory. The
                                               selection is made automatically and cannot be
                                               influenced by user.
6   Planmed Sophie Classic S                                                                  User’s Manual
                                                                                              SOPHIE CLASSIC S - MAIN PARTS
     4.8                     Detachable film markers (optional)
     4.9                     Chin guard
                                                                                      Chin guard
     4.10 CR interface adapter (optional)
                                                                              The optional CR (Computed Radiography) interface
                                                                              adapter is used when mammography images are
                                                                              taken using CR plates instead of conventional film
                                               CR                             cassettes. The exposure parameters used in the
                                                    Inte
                                                              rfac
                                                                  eA
                                                                     dap
                                                                              exposure are transferred to the CR console through
                                                                        ter
                                                                              the CR interface adapter.
            CR adapter.eps
                             Exp
                                   Sw
                                        itch
                                               X-ra
                                                   yU
                                                        nit
                                                                              CR readers and CR consoles provided by Agfa, Fuji
                                                                              and Konica-Minolta are supported. For instructions on
                                                                              using the CR reader and CR console, see the
                                                                              documentation provided by the manufacturer.
User’s Manual                                                                                        Planmed Sophie Classic S 7
SWITCHING THE X-RAY UNIT ON
       5      SWITCHING THE X-RAY UNIT ON
                    Base0198.eps
    On/off switch                                The on/off switch is located on the base behind the
                                                 fixed column. When the power is switched on the unit
                                                 will carry out a self-test, it lasts about 10 seconds,
                                                 during which the X-ray unit automatically checks itself.
                    Base
                                                 When the self-test is satisfactorily completed a
                                                 message indicating this will appear briefly on the
                                   tESt          keypad display.
                                                 The current time will then appear on the display which
                                                 indicates that the X-ray unit is ready for use.
                                   09:00
                                           NOTE If the letters Er (error) and a number (error
                                                number) appear on the display it means that
                                                there is something wrong with the X-ray unit
                                                and it did not pass the self-test. Refer to
                                   Er04         section     17    “ERRORS      AND   ERROR
                                                MESSAGES” on page 51.
                                           NOTE If the word StOP appears on the display it
                                                indicates that the emergency stop button on
                                                the hood has been pushed down. Pull the
                                   St0P         button up to clear the display and allow the X-
                                                ray unit to operate.
8    Planmed Sophie Classic S                                                              User’s Manual
                                                                                                        CONTROLS
              6      CONTROLS
                                                               This section describes where the controls are and how
                                                               they are used.
              6.1    C-arm controls
                                      Tubehead away            The X-ray unit has four C-arm control panels, two on
  C-arm up                                                     each side of the C-arm.
                                      from the user
                                                               The switches towards the front of the tubehead
                                                               change the angle of the C-arm. Pressing the upper
  Height adjusting
                                              C-arm rotation
                                                               switch will rotate the tubehead away from the user,
                                                               and pressing the lower switch will rotate the tubehead
                                              switches
  switches
                                                               towards the user.
                                                               The switches towards the rear of the tubehead adjust
                                                               the height of the X-ray unit by moving the C-arm up or
                                                               down.
  C-arm down                          Tubehead
                         Not in use   towards the user
                                                         NOTE The C-arm can be rotated to every projection
                                                              with these switches. However, it is
                                                              recommended to use the view selection keys
                                                              and only fine-tune the desired angle with
                                                              these switches.
                                                         NOTE In some countries X-ray units are set up so
                                                              that the C-arm will not move up or down when
                                                              the patient’s breast is compressed. Please
                                                              contact your Planmed sales representative if
                                                              you wish to use this feature.
              6.2    Foot controls (standard)
                                                               The X-ray unit has two foot controls, one on each side
                                                               of the base, which are used to move the compression
                                                               paddle up and down. The foot controls can be slid out
                                                               and individually positioned.
                                                               Pressing an holding down the inner switch of either
                                                               foot control will drive the compression paddle up, and
                                                               pressing and holding down the outer switch of either
                                                               foot control will drive the paddle down.
                                        Paddle up
                                                               The C-arm movement can be stopped while it is
                      Paddle down                              moving to the view position by pressing either foot
                                                               control switch.
                                                         NOTE In some countries X-ray units are set up so
                                                              that the C-arm will not automatically move to
                                                              the view selected when the view key is
                                                              pressed. See section 9.5 “Normal view
                                                              selection” on page 24.
User’s Manual                                                                         Planmed Sophie Classic S 9
CONTROLS
                                                             The foot controls can also be used to stop the X-ray
                                                             unit when it is moving to or from the transportation
                                                             position, see Section 15 “TRANSPORTING THE X-
                                                             RAY UNIT” on page 46.
                   6.3   Foot controls with five switches (optional)
                                                             As an option Sophie Classic S mammography X-ray
                                                             unit may have two foot controls with five switches, one
                                                             on each side of the base. They are identical (not
                                                             mirror images of each other). Either of them can be
     Futarit.eps
                                                             used to operate the X-ray unit.
                                                             Looking at either foot control with the cable to the rear,
                                                             the functions are (from left to right): C-arm up, C-arm
                                                             down, the middle switch is not in use; further to the
                                                             right: compression paddle up, compression paddle
                                                             down. The movement will stop when the switch is
                                                             released.
                                                             Note that the compression paddle can be moved up at
                                                             any time but will only move down after the view has
                                                             been selected and the C-arm is in the required view
                                not in                       position.
                                 use          Paddle
                    C-arm                     down           The X-ray unit can be stopped while it is moving to the
                    up    C-arm        Paddle
                                                             view position by pressing either paddle movement
                          down         up
                                                             switch.
                                                       NOTE In some countries X-ray units are set up so
                                                            that the C-arm will not move up or down when
                                                            the patient’s breast is compressed.
                                                       NOTE In some countries units are set up so that the
                                                            C-arm will not automatically move to the view
                                                            selected when the view key is pressed. See
                                                            section 9.5 “Normal view selection” on page
                                                            24.
10   Planmed Sophie Classic S                                                                            User’s Manual
                                                                                                                                                CONTROLS
             6.4                                                     Exposure control
                                                                                                      The exposure button and holder will be installed at a
                                                                                                      safe distance from the X-ray unit. The distance will
                                                                         Exposure                     depend on the local radiation safety regulations. When
                                                                         button                       you take an exposure you must hold the exposure
                                                                                                      button down for the duration of the exposure. If the
                                                                                                      button is released before the exposure is complete the
                                                                                                      error code Er 00 will appear on the display. Refer to
                                                                            OR                        section 17 “ERRORS AND ERROR MESSAGES” on
                                                                                                      page 51 for information on how to clear the error
                                                                                                      message.
                                                                        Holder
                                                                                                      There are two indicator lights on the exposure control
                                                                                                      holder. The green (lower) one will come on when the
                                                                                                      X-ray unit is ready to compress the breast, and the
                                                                        Er00        daN               yellow (upper) one will come on when you take an
                                                                                                      exposure.
                                                              Exposure interrupted
             6.5                                                     Emergency stop button
 Emergency stop button
                                                                                                     The emergency stop button is located on the hood.
                                                                                                     Press the button to stop the X-ray unit operating in an
                                                                                                     emergency. The message StOP will appear on the
                                                                                                     display. Pull the stop button up to start the X-ray unit
                                                                                          St0P   daN again.
              THIS
             AND X-RAY UNI      WARN
                 OPE
               AND RATOR MAY BE ING
                            T
                   OPE
                       RAT UNLESS DANGER              LBL-7
                          ING
                              INSTRUSAFE EXPOUS TO
                                                           87000
                                                                6A
                                     CTIO     OSU   PAT
                                          NS ARE RE FAC IENT
                                                 OBS    TOR
                                                     ERV      S
                                                         ED
                 OBL
        CC
                    LAT
                       DEX
  IN
                           kV
   kV
                             mAs
User’s Manual                                                                                                                Planmed Sophie Classic S 11
MAIN CONTROL PANEL
      7     MAIN CONTROL PANEL
                                            There are two main control panels, one on each side
                                            of the X-ray unit. They are identical and either, or both
                                            of them can be used to operate the X-ray unit
                                                                           Cranio-caudal key
          Left oblique view key                                            Right oblique view key
                Left lateral key                                           Right lateral key
                                                                           Angle display
                     Extra key     Extra
                     (invisible)    key
                                                                           kV up/down keys
                                                                           and display
                                                                           mAs up/down keys
                                                                           and display
                                                                           Density up/down keys
                                                                           and display
           Control (secondary                                              Compression release key
                function) key
                                                                           Field/light keys
            Time/force display                                             Breast thickness display
                                                                           Automatic/manual
              Sensor key and                                               exposure key and
               indicator light                                             indicator lights
                                                        Focal spot indicator lights
                                                 Filtration/spot key and indication lights
                                           Exposure/ready indicator lights
12   Planmed Sophie Classic S                                                           User’s Manual
                                                                            MAIN CONTROL PANEL
           Cranio-caudal key
                                               Press the cranio-caudal key to select the cranio-caudal
                                   CC          viewing angle. The C-arm will rotate to this position if it
                                               is not already there. The posterior-anterior viewing
                                               angle can also be selected using this key, see section
                                               14.4 “Posterior-anterior viewing angle” on page 40.
                                         NOTE In some countries X-ray units are set up so
                                              that the C-arm will not automatically move to
                                              the view selected when the view key is
                                              pressed. To start, and stop, the C-arm moving
                                              the foot control must be pressed. See section
                                              9.5 “Normal view selection” on page 24.
           Lateral keys (right and left)
                                               Press the left or right lateral key to select the lateral
                                   LAT         viewing angle. The C-arm will rotate to the horizontal
                                               position, either to the left or right. Press the key a
                                               second time when you want to stop the C-arm moving
                                               before it reaches the horizontal position. Press the key
                                               a third time to start the C-arm moving in the same
                                               direction again. View selection is discussed in more
                                               detail in Section 9.5 “Normal view selection” on page
                                               24 and in Section 9.6 “Three-second view selection”
                                               on page 28.
                                         NOTE In some countries X-ray units are set up so
                                              that the C-arm will not automatically move to
                                              the view selected when the view key is
                                              pressed. To start, and stop, the C-arm moving
                                              the foot control must be pressed. See section
                                              9.5 “Normal view selection” on page 24.
           Oblique keys (right and left)
                                               Press the oblique key to select the oblique viewing
                                   OBL         angle. The C-arm will rotate to the angle previously
                                               used in oblique projection. The angle will appear on
                                               the angle display. Press the key a second time to stop
                                               the C-arm moving before it reaches the correct
                                               position. Press the key a third time to start the C-arm
                                               moving in the same direction again. View selection is
                                               discussed in more detail in Section 9.5 “Normal view
                                               selection” on page 24 and in Section 9.6 “Three-
                                               second view selection” on page 28.
                                         NOTE In some countries X-ray units are set up so
                                              that the C-arm will not automatically move to
                                              the view selected when the view key is
                                              pressed. To start, and stop, the C-arm moving
                                              the foot control must be pressed. See section
                                              9.5 “Normal view selection” on page 24.
           Angle display
                                               The viewing angle in degrees is shown on the angle
                                               display.
                                               After the exposure has been taken, the amount of
                                               radiation (mGy) emitted from the tube during exposure
                                               will be shown on the angle display. The value is
User’s Manual                                                          Planmed Sophie Classic S 13
MAIN CONTROL PANEL
                                              calculated based on the mAs value and it represents
                                              the incident dose 4 cm above the Bucky. The value will
                                              remain on the display until a key is pressed.
                                              If required, the X-ray unit can be set up so that the
                                              radiation display is switched off. Contact your local
                                              sales representative.
                                        NOTE The unit has an additional angle display on
                                             the base.
           kV keys and display
                                              Allows you to select the kV value. Select the kV value
                kV                kV          with the up and down keys, the kV value is adjustable
                                              from 20 to 35 kV in steps of 1 kV.
           mAs keys and display
                                              The mAs values can only be selected when the X-ray
                 mAs              mAs         unit is used in the manual mode. Taking exposures in
                                              the manual mode is described in section 13 “MANUAL
                                              EXPOSURE PROCEDURE” on page 37.
                                              Select the mAs value with the up and down keys. The
                                              mAs value is adjustable from 10 to 500 (in some areas
                                              the maximum mAs value is 600) with the large focus
                                              and 10 to 400 with the small focus, depending on the
                                              kV value selected.
           Density keys and display
                                              The density keys allow you to select the film density,
                                              see section 8.5 “Adjusting the film density” on page 22.
                                              It will only function when you are taking exposures in
                                              the AEC modes. Note that the cassette, screen, film,
                                              type of film processor, and processing chemicals will
                                              affect the film density.
                                              The effective range of the density keys can be
                                              adjusted by your local Planmed sales representative.
           Control (secondary function) key
                                              Press the control key to activate the special function
                                  CTL         mode. The indicator light will come on. The control key
                                              is also used to clear error codes from the display.
14   Planmed Sophie Classic S                                                           User’s Manual
                                                                          MAIN CONTROL PANEL
           Compression release key
                                             Press the release key after taking an exposure to
                                             release the compression paddle.
                                             To minimize patient discomfort you can set the paddle
                                             to automatically open immediately after an exposure
                                             has been taken. See section 8.4 “Automatic paddle
                                             release” on page 22. When the indicator light is on the
                                             automatic paddle release is activated. When the light
                                             is off the function is not activated.
                                       NOTE When performing biopsy, the automatic
                                            compression release function MUST be
                                            switched OFF.
           Field/light keys
                                             Press one of these keys to switch the field light on. The
                                             light that appears on the Bucky corresponds to the
                                             radiation field. The size of the light field, and therefore
                                             the radiation field, can be adjusted with these keys. To
                                             enlarge the field, press the key on the right side of the
                                             control panel, and to reduce it press the key on the left
                                             side.
                                             These keys are also used as minus and plus keys
                                             when changing parameter values.
           Time/force display
                                             In stand-by mode the current time is displayed on the
                                             time/force   display.  During     compression     the
                                      daN    compressive force is shown on this display in
                                             decanewtons (daN).
                                             When the magnification platform is attached in
                                             position, the corresponding magnification factor is
                                             shown on the display for five seconds.
                                       NOTE The X-ray unit has an additional time/force
                                            display on the base.
           Breast thickness display
                                             The distance between the compression paddles, i.e.
                                             breast thickness, in centimeters is shown on the breast
                                             thickness display.
                                             After the exposure the actual duration of the exposure
                                             in seconds is shown on the display.
                                       NOTE The X-ray unit has an additional breast
                                            thickness display on the base.
User’s Manual                                                        Planmed Sophie Classic S 15
MAIN CONTROL PANEL
           Sensor key and indicator lights
                                                In the AEC modes you must select the position of the
                                  3 2 1         radiation sensor according to the size of the patient’s
                                                breast. Select the sensor you require by pressing the
                                                sensor key, the indicator lights refer to the markings
                                                and numbers on the compression paddles.
                                          3
                                                Position 1 indicates that the sensor is close to the
                                          2
                                          1     chest wall and is normally used for taking exposures in
                                                the cranio-caudal view and with patients with small
                                                breasts.
                                          3
                                                Position 2 is normally used for taking exposures in the
                                          2     oblique view and with patients with normal size
                                          1     breasts.
                                                Position 3 is normally used for taking exposures with
                                          3
                                          2     patients with large breasts. Note that this position
                                          1     cannot be selected in the spot mode.
           Automatic/manual exposure key and indicator lights
                                   AAEC         This key is used to select either the manual exposure
                                   AEC
                                                mode or either of the AEC (automatic exposure
                                   MAN
                                                control) modes. There are two AEC modes,
                                                conventional AEC and the advanced AEC (AAEC).
                                                The indicator light shows the selected exposure mode.
                                                The focal spot size is changed by pressing and holding
                                                the automatic/manual exposure key for 4 seconds.
                                                The focal spot indicator lights show the selected focal
                                                spot.
           Focal spot indicator lights
                                                When this indicator light is on it indicates that the large
                                                focal spot has been selected.
                                                When this indicator light is on it indicates that the small
                                                focal spot has been selected.
                                                The large focal spot is normally used for contact view
                                                procedures, and the small focal spot for more detailed
                                                diagnostic procedures. The focal spot size is toggled
                                                by pressing the automatic/manual exposure key for 3
                                                seconds.
                                          NOTE When the magnification platform is attached
                                               in position the small focal spot is
                                               automatically selected, and when it is
                                               removed the large focal spot is selected.
16   Planmed Sophie Classic S                                                                User’s Manual
                                                                          MAIN CONTROL PANEL
           Filtration/spot collimator key and indicator lights
                                       NOTE The filters are installed at the factory. Their
                                            selection is made automatically and cannot be
                                            influenced by user.
                                             When this indicator light is on it indicates that the 0.5
                                      Rh
                                      Al     mm thick aluminium filter is in use.
                                      Mo
                                      Rh     When this indicator light is on it indicates that the
                                      Al
                                      Mo
                                             30 µm thick molybdenum filter is in use.
                                             When this indicator light is on it indicates that the
                                      Rh     25 µm Rh filter is in use (optional).
                                      Al
                                      Mo
                                       NOTE If the unit is equipped with the optional
                                            rhodium filter, the aluminium filter is not
                                            available.
                                             Since the filter selection in Sophie Classic S is fully
                                             automatic, the filtration / spot collimator key is used
                                             only to select the spot collimator.
                                             The spot collimator is selected by pressing and holding
                                             the filtration/spot key for 2 seconds. The filtration/spot
                                             key indicator light and the molybdenum filter indicator
                                             light come on. The spot paddle should be used with
                                             the spot collimator.
                                       NOTE The X-ray unit can be set up so that the small
                                            focal spot is automatically selected when the
                                            spot collimator is selected. Contact your sales
                                            representative.
           Ready indicator light
                                   READY     The ready indicator light will come on when the
                                   PRET      cassette is loaded. It indicates that the X-ray unit is
                                             ready to compress the breast.
                                             Note that the green indicator light on the exposure
                                             control holder will also come on.
User’s Manual                                                        Planmed Sophie Classic S 17
MAIN CONTROL PANEL
           Exposure warning indicator light
                                          The exposure warning indicator light will come on
                                  EXP
                                          when you take an exposure. You will also hear two
                                          tones during the exposure period. The first tone is the
                                          start up tone and the second, a higher tone, is the
                                          exposure tone. When the exposure is complete the
                                          tone will stop.
                                          Note that the yellow indicator light on the exposure
                                          control holder will also come on.
18   Planmed Sophie Classic S                                                       User’s Manual
                                                                           PREPARING THE X-RAY UNIT
     8                      PREPARING THE X-RAY UNIT
                                                    This section explains how to prepare the X-ray unit for
                                                    your particular requirements. In normal circumstances
                                                    this preparation work only needs to be done if you are
                                                    using the X-ray unit for the first time, changing
                                                    compression paddles or if you are going to carry out
                                                    some special procedures.
     8.1                     Attaching and removing the Bucky
                                                    There are two sizes of Bucky, 18x24cm and 24x30cm.
                                                    Select the correct Bucky size according to the cassette
                                                    you plan to use.
                                                    Slide the Bucky along the shelf surface until it is locked
                                                    into position. Make sure the Bucky is firmly locked in
                                                    place.
         bucky1.eps
                                                    To remove the Bucky, pull the release knob on the
                                                    underside of the shelf towards you to disengage the
                                                    locking mechanism, then slide the Bucky out.
               bucky2.eps
                                   Release knob
User’s Manual                                                               Planmed Sophie Classic S 19
PREPARING THE X-RAY UNIT
      8.2       Attaching and removing the compression paddle
                                                Press the compression release key to move the
                                                paddle holder up. This ensures that you will have
                                                enough space between the paddle holder and Bucky
                                                when attaching the compression paddle.
       painim
                                                There are two sizes of compression paddle, 18x24cm
                                                and 24x30cm.
                                                First place the compression paddle in the paddle
                                Paddle holder   holder in a downwards tilted position.
                                                Then turn the paddle up to lock it into position.
                                                To remove the paddle, first press the compression
                                                release key to move the paddle holder to the home
                                                position. Then tilt the paddle down and lift it off.
20   Planmed Sophie Classic S                                                               User’s Manual
                                                                                                        PREPARING THE X-RAY UNIT
     8.3                                                Attaching and removing the open cassette holder and the
                                                        magnification platform(optional)
           Open cassette holder
                                                                            NOTE You only need to use the open cassette holder
                                                                                 when you take magnification views.
                                                                                  There is one size of open cassette holder (18 x 24cm).
                                                                                  Use the holder with a cassette of the same size.
                                                                                  Slide the open cassette holder along the shelf surface
                                                                                  until it is locked into position. Make sure the cassette
                                                                                  holder is firmly locked in place.
            kasettitunneli1.eps
                                                                                  To remove the open cassette holder, pull the release
                                                                                  knob on the underside of the shelf towards you to
                                                                                  disengage the locking mechanism, then slide the
                                                                                  holder out.
                                  kasettitunneli2.eps
                                                                       Release
                                                                       knob
User’s Manual                                                                                            Planmed Sophie Classic S 21
PREPARING THE X-RAY UNIT
                           Magnification platform
                                                                           There are two positions where the magnification
                                                                           platform can be attached. The magnification factor of
                                                                           the upper position is 1.8, and the magnification factor
                                1.8                                        of the lower position is 1.6.
                                1.6                                        To place the magnification platform in position slide
                                                                           the pins at the rear of the platform into the
                                                                           corresponding holes in the C-arm. Slide also the small
                                                                           pins on the lower edge of the platform into the holes in
        mag-classic1.eps
                           mag-classic1.eps
                                                                           the open cassette holder.
                                                                   NOTE The compression paddle must be driven
                                                                        above the mounting holes before attaching
                                                                        the magnification platform.
                                                                           When the magnification platform is attached in
                                                                           position, the magnification is shown on the breast
                                                             1.8           thickness display for 5 seconds.
                                                                   NOTE If the magnification factor is not shown, the
                                                                        platform is not properly placed in position.
      8.4                                     Automatic paddle release
                                                                           To minimize patient discomfort you can set up the X-
                                                                           ray unit so that the compression paddle will
                                                                           automatically open after an exposure has been taken.
                                                                   NOTE This MUST NOT be activated if a biopsy is to
                                                                        be taken.
                                                                           Press the control key to activate the secondary
                                                                 CTL       function mode. The indicator light will come on.
                                                                           Press the paddle release key to activate the automatic
                                                                           paddle release function. The indicator light will come
                                                                           on when the function is switched on.
                                                                           To cancel the function, repeat the above procedure.
      8.5                                     Adjusting the film density
                                                                           The density of the film can be adjusted if required. It
                                                                           can only be adjusted in the AEC and AAEC modes.
                                                                           Note that the cassette, screen, film, type of film
                                                                           processor, processing chemicals and temperatures
                                                                           used will affect the film density.
                                                                           Select the density with the density up and down keys.
                                                                           The density level has 15 steps from -7 (light
                                                                           exposures) to +7 (dark exposures).
                                                                           The effective range of the density keys can be
                                                                           adjusted by your local Planmed sales representative.
22   Planmed Sophie Classic S                                                                                        User’s Manual
                                                                           CONTACT VIEW PROCEDURE
     9                   CONTACT VIEW PROCEDURE
                                                      The following section describes how to take exposures
                                                      with the X-ray unit using the AEC (automatic exposure
                                                      control) modes. For information on how to take
                                                      exposures manually see section 13 “MANUAL
                                                      EXPOSURE PROCEDURE” on page 37.
     9.1                  Loading the cassette
                                                      Make sure you insert the cassette the right way round.
                                                      Slide the cassette into the cassette opening until the
                                                      locking mechanism clicks.
                                                NOTE Check that the cassette is pushed to the
                                                     bottom and locked firmly in place.
                                                NOTE Avoid using unnecessary force when loading
           kasetti.eps
                                                     and unloading the cassette.
     9.2                  Setting the exposure values
                                            AAEC      Select automatic exposure control (AEC/AAEC) mode
                                            AEC       if it is not already selected.
                                            MAN
                                                      With conventional AEC the correct kV must be
                                                      selected before exposure, and with the AAEC mode a
                                                      kV value will be automatically selected before, and
                                                      adjusted during, the exposure.
                                                      When the AEC mode has been selected the exposure
                                                      time will appear on the breast thickness display after
                                                      the exposure.
                                                      If you are using the conventional AEC mode select the
                                    kV     kV         kV value required for the patient to be examined.
                                                NOTE You can set the X-ray unit so that it will
                                                     automatically display a recommended kV
                                                     value after the breast has been compressed.
                                                     See section 14.1 “Automatic kV selection in
                                                     AEC mode” on page 38.
User’s Manual                                                               Planmed Sophie Classic S 23
CONTACT VIEW PROCEDURE
       9.3                          Height adjustment
                                                                     Adjust the height of the X-ray unit to suit the patient.
                                                                     Press the upper height adjustment switch to move the
                                                                     C-arm up, or press the lower height adjustment switch
     Height                                                          to move the C-arm down.
     adjustment
       9.4                          Radiation level selection
                                                                     Select the radiation level sensor according to the
                                                      3 2 1          exposure view selected and the build of the patient.
                                                                     The display numbers correspond to the numbers and
                                                                     markings on the compression paddles.
       9.5                          Normal view selection
                                                                     Select the exposure view you are going to use from
                                                                     the film marker selection (optional). Lift the marker bar
                                                                     slightly upwards and push the marker into the bar.
                                                                     Allow the bar to drop down onto the Bucky surface.
                                                                     You can slide the marker along the bar within the limits
                                                                     of the locking grooves.
             marking_sophie_s.eps
                                                                     Select the exposure view you require by pressing one
                                          or                         of the view keys. The different views are explained
                                    OBL        LAT   or   CC
                                                                     below. The C-arm will move to the view selected if it is
                                                                     not already in that position. The C-arm movement can
                                                                     be stopped by pressing the key again.
                                                               NOTE Detailed instructions for each view are given
                                                                    starting from Section 9.5.1 “Cranio-caudal
                                                                    view” on page 25.
24   Planmed Sophie Classic S                                                                                   User’s Manual
                                                                        CONTACT VIEW PROCEDURE
                                            NOTE In some countries X-ray units are set up so
                                                 that the C-arm will not automatically move to
                                                 the view selected when the view key is
                                                 pressed. To move the C-arm to the view
                                                 selected press and hold down the “paddle up”
                                                 or “paddle down” switch on the foot control.
                                                 To stop the C-arm moving remove your foot
                                                 from the foot control.
                                 Paddle up
                Paddle down
                                      READY       The READY indicator light on the control panel and the
                                      PRET        exposure control holder will come on when the
                                                  cassette is loaded, the viewing angle selected, and the
                                                  C-arm in the correct position. It indicates that the X-ray
                                                  unit is ready to compress the breast.
                                            NOTE The READY indicator light may be lit even if
                                                 the cassette was not properly secured in
                                                 position. Make sure the cassette is pushed to
                                                 the bottom and locked firmly in place.
     9.5.1 Cranio-caudal view
                                       CC
                                                  Press the cranio-caudal key to select the cranio-caudal
                                                  view. The C-arm will remain in the vertical position or
                                                  move to the vertical position from one of the other
                                                  views.
                              Tubehead away       The cranio-caudal viewing angle can be adjusted
     10                       from the user       within the maximum range +/- 15⁰  from the C-arm
                                                  rotation switches. The C-arm can be rotated in both
                                                  the clockwise and the counterclockwise direction. The
                                                  new angle will appear on the angle display.
        C-arm rotation        Tubehead
        switches              towards the user
User’s Manual                                                             Planmed Sophie Classic S 25
CONTACT VIEW PROCEDURE
       9.5.2 Medio-lateral oblique view
                                                          Press the right oblique key to select the medio-lateral
                                                          oblique view of the left breast, or press the left oblique
                                                          key to select the medio-lateral oblique view of the right
                                                          breast. The C-arm will rotate to the angle previously
                                                          selected, either to the left or the right, depending on
                                                          which key you have pressed. The angle will appear on
                                            right OBL key
                                                          the angle display.
                                                         Setting the preset angle is described in section 14.3
                                                         “Setting the oblique view angle” on page 39.
     Left breast
                                Tubehead away            The C-arm angle can be adjusted with the C-arm
       36                       from the user            rotation switches within the maximum range +/- 15⁰. If
                                                         the new angle is between 30°-75° it will be
                                                         automatically stored in the memory and will be recalled
                                                         by pressing the oblique key.
            C-arm rotation      Tubehead
            switches            towards the user
       9.5.3 Latero-medial oblique view
                                                         Press the left oblique key to select the latero-medial
                                                         oblique view of the left breast, or press the right
                                                         oblique key to select the latero-medial oblique view of
                                                         the right breast. The C-arm will rotate to the angle
                             Left OBL key
                                                         previously selected, either to the left or the right,
                                                         depending on which key you have pressed. The angle
                                                         will appear on the angle display.
                                                         Setting the preset angle is described in section 14.3
            Left breast
                                                         “Setting the oblique view angle” on page 39.
                                                         The C-arm angle can be adjusted with the C-arm
                                Tubehead away            rotation switches within the maximum range +/- 15⁰. If
       36                       from the user            the new angle is between 30°-75° it will be
                                                         automatically stored in the memory and will be recalled
                                                         by pressing the oblique key.
            C-arm rotation      Tubehead
            switches            towards the user
26    Planmed Sophie Classic S                                                                        User’s Manual
                                                                                         CONTACT VIEW PROCEDURE
      9.5.4 Latero-medial view
                                                                   Press the left lateral key to select the latero-medial
                                                                   view of the left breast, or press the right lateral key to
                                                                   select the latero-medial view of the right breast. The C-
                                                                   arm will rotate to the horizontal position, either to the
                                    Left LAT key                   left or right depending on which breast you selected.
                                                                   The angle will appear on the angle display.
             Left breast
                                        Tubehead away              The latero-medial viewing angle can be adjusted with
      82                                from the user              the C-arm rotation switches within the maximum range
                                                                   +/- 15⁰. The C-arm can be rotated in both the
                                                                   clockwise and the counterclockwise direction. The new
                                                                   angle will appear on the angle display.
                                        Tubehead
                   C-arm rotation       towards the user
                   switches
      9.5.5 Medio-lateral view
                                                                   Press the right lateral key to select the medio-lateral
                                                                   view of the left breast, or press the left lateral key to
                                                                   select the medio-lateral view of the right breast. The C-
                                                                   arm will rotate to the horizontal position, either to the
                                                   Right LAT key   left or right depending on which breast you selected.
                                                                   The angle will appear on the angle display.
   Left breast
                                       Tubehead away               The medio-lateral viewing angle can be adjusted with
       95                              from the user               the C-arm rotation switches within the maximum range
                                                                   +/- 15⁰. The C-arm can be rotated in both the
                                                                   clockwise and the counterclockwise direction. The new
                                                                   angle will appear on the angle display.
                                            Tubehead
                                            towards the user
                           C-arm rotation
                           switches
User’s Manual                                                                              Planmed Sophie Classic S 27
CONTACT VIEW PROCEDURE
        9.6        Three-second view selection
               Posterior-anterior view
                                                       Press and hold the CC key for three seconds and the
                                                       C-arm will rotate to the PA position.
                                              CC key
                                                       Note that the physical limits of the X-ray unit will not
                                                       allow you to adjust the angle of the PA position in the
                                                       clockwise direction.
               Latero-medial oblique view
                                                       Press and hold the left OBL key for three seconds to
                                                       select the latero-medial oblique view of the left breast,
                                                       or press the right OBL key for three seconds to select
                                    Left OBL key       the latero-medial view of the right breast.
                                                       The C-arm will rotate to the previously selected angle,
                                                       either to the left or the right, depending on which key
                                                       you have pressed. The angle will appear on the angle
     Left breast                                       display. Setting the preset angle is described in
                     i     bl2
                                                       section 14.3 “Setting the oblique view angle” on page
                                                       39.
               Latero-medial view
                                                       Press and hold the left LAT key for three seconds to
                                                       select the latero-medial view of the left breast, or press
                                                       the right LAT key for three seconds to select the
                                    Left LAT key       latero-medial view of the right breast.
                                                       The C-arm will rotate to the horizontal position, either
                                                       to the left or right depending on which key you have
     Left breast                                       pressed. The angle will appear on the angle display.
                    view lat1 eps
28    Planmed Sophie Classic S                                                                     User’s Manual
                                                  BREAST COMPRESSION AND TAKING EXPOSURES
     10 BREAST COMPRESSION AND TAKING EXPOSURES
     10.1 Breast compression
                                                    Position the breast to be examined on the Bucky or
                                                    magnification platform. The chest below the breast
                                                    should be pressed against the front edge of the Bucky.
                                                    Manipulate and spread the breast forwards and
                                                    outwards as much as possible on the Bucky.
                                                    Place the foot control to a suitable position and then
                                                    start compression by pressing the outer edge of either
                     paddle down
                                                    foot control. The field light will automatically come on.
                                                    The compression paddle will start to descend while
                                                    remaining parallel to the Bucky.
                                                    During this phase of the breast compression the
                16   daN        6.5                 maximum limit (in decanewtons) at which the
                                                    compressive force is set will appear on the time/force
    Compression force      Breast thickness         display and start to flash.
                                                    When the compressive force reaches the preset limit
                                                    you will hear a tone and compression will stop. To
                                                    continue compression stop and then start pressing the
                                                    compression control again. The paddle will start to
                                                    descend again, but this time at a slower speed. To
                                                    adjust the speed of compression refer to section 14.5
                                                    “Setting the speed of the compression paddle
                                                    movement” on page 40.
                                      CAUTION Be careful not to leave your hands
                                              between the compression paddles during
                                              compression.
                                                    Compression can be stopped by releasing the foot
                                                    control. To continue compression press the foot
                                                    control again.
           Implant- included views
                                              NOTE The degree of compression is limited by the
                                                   compressibility of the implant. Deliver just
                                                   enough compression to immobilize the
                                                   breast.
User’s Manual                                                              Planmed Sophie Classic S 29
BREAST COMPRESSION AND TAKING EXPOSURES
                                                               Adjust the size of the radiation field if necessary.
                                                               To do this press the field/light key to switch the
                                                               radiation field light on. Adjust the size of the field by
                                                               pressing either of the field/light keys.
         sophie_fieldlight.eps
                                                Field light
                                                               The paddle can be moved upwards by pressing the
                                                               inner switch of either foot control.
                                             Paddle
                                             up
      10.2 Emergency compression release
                                                               To release the compression in an emergency press
                                                               this key or the foot control. Do not press the
                                                               emergency stop button in this situation as
                                                               this will stop the X-ray unit working.
                                 Standard compression paddle
                                                               If there is a power failure while you are examining a
                                                               patient the quickest and easiest way to release the
                                                               compression paddle is to turn the release handle
                                 Release                       down.
                                 handle
30   Planmed Sophie Classic S                                                                              User’s Manual
                                       BREAST COMPRESSION AND TAKING EXPOSURES
     10.3 Taking an exposure
                                         Before taking an exposure make sure that the patient’s
                                         head or shoulder does not get in the way of the
                                         radiation beam.
                                         Protect yourself from radiation.
                                   NOTE The minimum required protective shielding is
                                        60 cm wide, minimum 185 cm high, and less
                                        than 15 cm above the floor. The material used
                                        must have a minimum attenuation equivalent
                                        of 0.08 mm of lead and it must provide
                   .2 m
                                        visibility to the patient and equipment. Note
                4 7 1 .2
                      "
                   in
                                        that local regulations must be obeyed in case
                m
                                        they differ from the above.
                                         Take an exposure by pressing the remote control
                       OR                button. Note that the button must be held down for the
                                         duration of the exposure. If you remove your finger
                                         from the exposure button before the exposure is
                                         complete an error code will appear on the display. For
                                         more information refer to section 17 “ERRORS AND
                                         ERROR MESSAGES” on page 51.
                                         The exposure warning lights on the control panels and
                                         the exposure control holder will come on and you will
                                         hear two tones during the exposure period. The first
                                         tone is the start up tone and the second, a higher tone,
            CAUTION:X-RAYS       EXP     is the exposure tone. When the exposure is complete
            ATTENTION:RAYONS-X           the tone will stop.
User’s Manual                                                   Planmed Sophie Classic S 31
BREAST COMPRESSION AND TAKING EXPOSURES
      10.4 After exposure
                                         If the automatic compression release function is
                                         switched on, the compression paddle will automatically
                                         open after the exposure is completed.
                                         If the automatic compression release function is not
                                         activated, press the compression release key to
                                         release the compression paddle. The paddle will
                                         automatically move to the ready position. You can also
                                         release the compression paddle by pressing and
                                         holding down the inner switch of either foot control.
                                         Note, however, that the paddle will only move as long
                                         as you hold the control down, and the paddle will not
                                         automatically rise to the ready position.
                                         Guide the patient away from the X-ray unit.
                                Paddle
                                up
                                         Another exposure can be taken as soon as the time
                                         reappears on the display. The delay time shown on-
                                         line on the time/force display will depend on the
                                         exposure parameters used.
32   Planmed Sophie Classic S                                                     User’s Manual
                                                                MAGNIFICATION PROCEDURES (OPTIONAL)
                       11 MAGNIFICATION PROCEDURES (OPTIONAL)
                                                             The following section describes how to use the X-ray
                                                             unit for assessment work.
                       11.1 Magnification procedure with standard compression paddle
                                                             Drive the C-arm to the cranio-caudal position.
                                                             Place the compression paddle in the paddle holder.
                                                             Drive the paddle above the magnification platform
                                                             mounting holes.
                                                             To place the open cassette holder in position, slide it
                                                             along the shelf surface until it is locked into position.
                                                             Load the cassette (refer to section 9.1 “Loading the
                                                             cassette” on page 23).
                                                             To place the magnification platform in position, slide
                                                             the pins at the rear of the platform into the
                                            1.8        daN
                                                             corresponding holes in the C-arm. Slide also the small
                                                             pins on the lower edge of the platform into the holes in
                                                             the open cassette holder. When the platform is
                                                             attached into the upper mounting holes the
                                       Compression           magnification is 1.80, and when the platform is
                                       paddle                installed into the lower mounting holes the
                                                             magnification is 1.60. The magnification factor is
                                                             shown on the time/force display for 5 seconds.
    mag-classic2.eps
                                       Magnification
                                       platform
                                                             Note that the small focal spot and the correct mAs
                                                             range will be automatically selected when the
                                                             magnification platform is placed in position. When you
                                                             want to use the large focal spot, press and hold the
                                                             automatic/manual exposure key until the large focal
   Open cassette holder
                                                             spot indicator lights comes on.
                                                             You can now select the exposure view, set the
                                                             exposure parameters, compress the breast, and take
                                                             an exposure. Refer to sections 9 “CONTACT VIEW
                                                             PROCEDURE” on page 23 and 10 “BREAST
                                                             COMPRESSION AND TAKING EXPOSURES” on
                                                             page 29.
User’s Manual                                                                       Planmed Sophie Classic S 33
MAGNIFICATION PROCEDURES (OPTIONAL)
      11.2 Magnification procedure with spot paddle
                                                 Drive the C-arm to the cranio-caudal position.
                                                 Place the spot paddle in the paddle holder. Drive the
                                                 paddle above the magnification platform mounting
                                                 holes.
                                                 To place the open cassette holder in position, slide it
                                                 along the shelf surface until it is locked into position.
                                  1.8      daN   Load the cassette (refer to section 9.1 “Loading the
                                                 cassette” on page 23).
                                                 To place the magnification platform in position, slide
                                                 the pins at the rear of the platform into the
                                                 corresponding holes in the C-arm. Slide also the small
                                                 pins on the lower edge of the platform into the holes in
                                                 the open cassette holder. When the platform is
                                                 attached into the upper mounting holes the
                                Spot paddle      magnification is 1.80, and when the platform is
                                                 installed into the lower mounting holes the
                                                 magnification is 1.60. The magnification factor is
                                Magnification
          mag-spot.eps
                                                 shown on the time/force display for 5 seconds.
                                platform
                                                 Note that the small focal spot is automatically selected
                                                 when the magnification platform is placed in position.
       Open cassette holder
                                                 Select the spot collimator by pressing and holding the
                                                 filtration/spot key for 2 seconds. The filtration/spot key
                                                 indicator light will come on.
                                         NOTE When using the spot collimator the breast
                                              thickness read-out is adjusted for the spot
                                              paddle.
                                         NOTE The X-ray unit can be set up so that the spot
                                              collimator is automatically selected when the
                                              magnification platform is placed in position.
                                              Contact your sales representative.
                                         NOTE The X-ray unit can be set up so that the
                                              standard rectangular collimator is selected in
                                              the spot mode instead of the spot collimator,
                                              but the breast thickness read-out is adjusted
                                              for the spot paddle. Contact your sales
                                              representative.
                                                 You can now select the exposure view, set the
                                                 exposure parameters, compress the breast, and take
                                                 an exposure. Refer to sections 9 “CONTACT VIEW
                                                 PROCEDURE” on page 23 and 10 “BREAST
                                                 COMPRESSION AND TAKING EXPOSURES” on
                                                 page 29.
34   Planmed Sophie Classic S                                                                User’s Manual
                                                  BIOPSY PROCEDURES (OPTIONAL)
     12 BIOPSY PROCEDURES (OPTIONAL)
     12.1 Biopsy procedure with perforated biopsy paddle
                                   Place the perforated biopsy paddle in the paddle
                                   holder.
                             NOTE Make sure that the automatic compression
                                  release is NOT switched on, the indicator light
                                  must be off.
                                   Place the Bucky in position and load the cassette.
                                   Refer to sections 8.1 “Attaching and removing the
                                   Bucky” on page 19 and 9.1 “Loading the cassette” on
                                   page 23.
                                   You can now select the exposure view, set the
                                   exposure parameters, compress the breast, and take
                                   an exposure. Refer to sections 9 “CONTACT VIEW
                                   PROCEDURE” on page 23 and 10 “BREAST
                                   COMPRESSION AND TAKING EXPOSURES” on
                                   page 29.
                                   After the exposure do not release the compression.
                                   Remove the cassette by pressing the locking
                                   mechanism backwards and simultaneously pushing
                                   the cassette out from the opposite side. Process the
                                   film. The pattern of holes in the perforated paddle will
                                   be seen on the film. Localize the position of the lesion
                                   and insert the biopsy needle through an appropriate
                                   hole in the biopsy paddle.
                                   Take a second exposure.
                                   Process the film. If the biopsy needle is in the right
                                   place, take the biopsy. If the needle is not in the right
                                   place, take another exposure. Repeat the procedure
                                   until the biopsy can be taken.
                                   Instead of a biopsy needle you can also use
                                   localization wire or take a cytological sample with an
                                   appropriate needle or syringe.
User’s Manual                                             Planmed Sophie Classic S 35
BIOPSY PROCEDURES (OPTIONAL)
      12.2 Biopsy procedure with rectangular biopsy paddle
                                      Place the rectangular biopsy paddle in the paddle
                                      holder.
                                NOTE Make sure that the automatic compression
                                     release is NOT switched on, the indicator light
                                     must be off.
                                      Place the Bucky in position and load the cassette.
                                      Refer to sections 8.1 “Attaching and removing the
                                      Bucky” on page 19 and 9.1 “Loading the cassette” on
                                      page 23.
                                      You can now select the exposure view, set the
                                      exposure parameters, compress the breast, and take
                                      an exposure. Refer to sections 9 “CONTACT VIEW
                                      PROCEDURE” on page 23 and 10 “BREAST
                                      COMPRESSION AND TAKING EXPOSURES” on
                                      page 29.
                                      After the exposure do not release the compression.
                                      Remove the cassette by pressing the locking
                                      mechanism backwards and simltaneously pushing the
                                      cassette out from the opposite side. Process the film.
                                      The scale of the rectangular paddle will be seen on the
                                      film. Install the hair cursor attachment to the collimator
                                      slot, and switch the field light on. Now localize the
                                      position of the lesion by moving the hair cursor wire to
                                      the lesion position. When the field light illuminates the
                                      hair cursor, the shadow will be cast on the breast
                                      tissue thus helping you to insert the needle into the
                                      lesion.
                                      Take a second exposure.
                                      Process the film. If the biopsy needle is in the right
                                      place, take the biopsy. If the needle is not in the right
                                      place, take another exposure. Repeat the procedure
                                      until the biopsy can be taken.
                                      Instead of a biopsy needle you can also use
                                      localization wire or take a cytological sample with an
                                      appropriate needle or syringe.
                                      The X-ray unit can be stopped while it is moving to the
                                      view position by pressing either paddle movement
                                      switch.
36   Planmed Sophie Classic S                                                     User’s Manual
                                                   MANUAL EXPOSURE PROCEDURE
     13 MANUAL EXPOSURE PROCEDURE
                                   Select the manual exposure mode by pressing the
                      AAEC         manual/automatic exposure key so that the
                      AEC
                      MAN
                                   appropriate indicator light will come on. The density
                                   display will clear.
                                   Load the cassette. Refer to section 9.1 “Loading the
                                   cassette” on page 23.
                                   Select the required kV value according to the build of
                kV
                        25   kV
                                   the patient.
                                   Now select an mAs value with the mAs up and down
                mAs
                       65    mAs   keys.
                                   You can now compress the breast and take an
                                   exposure. Refer to sections 9 “CONTACT VIEW
                                   PROCEDURE” on page 23 and 10 “BREAST
                                   COMPRESSION AND TAKING EXPOSURES” on
                                   page 29.
User’s Manual                                            Planmed Sophie Classic S 37
SPECIAL FUNCTIONS
      14 SPECIAL FUNCTIONS
                                                The following section describes the X-ray unit’s special
                                                functions.
      14.1 Automatic kV selection in AEC mode
                                          NOTE To perform the automatic kV selection the
                                               AEC mode must be first selected.
                                                This function automatically selects a recommended kV
                                                value after the breast has been compressed. The kV
                                                value is based on the thickness of the compressed
                                                breast.
                                                To activate this function press the control key to select
                                    CTL         the secondary function mode. The indicator light will
                                                come on.
                                                Press the kV up key and one of two messages will
                                    kV          appear on the time/force display and start to flash. The
                                                message will depend on whether the automatic kV
                                                selection mode was previously switched on or off.
                                                This message indicates that the automatic kV
                                0 F FA    daN
                                                selection mode is switched off.
                                          NOTE If the advanced AEC mode is selected, the
                                               automatic kV selection is on regardless of this
                                               setting.
                                                Switch the automatic kV selection mode on by
                                                pressing the right field/light key.
                                                This message indicates that the automatic kV
                                0n A      daN   selection mode is switched on.
                                                Switch the automatic kV selection mode off by
                                                pressing the left field/light key.
                                                Press the control key to accept the new or existing
                                    CTL         mode.
      14.2 Selecting the AEC mode
                                                There are two AEC modes, conventional AEC and
                                                advanced AEC (AAEC). With conventional AEC you
                                                must select the kV required before taking an exposure.
38   Planmed Sophie Classic S                                                              User’s Manual
                                                                           SPECIAL FUNCTIONS
                                            With advanced AEC kV value is selected after the
                                            patient’s breast has been compressed and then this
            AAEC             AAEC           value is automatically corrected during the exposure.
            AEC              AEC            The kV value is based on the tissue density of the
            MAN              MAN
                                            patient’s breast.
        Advanced        Conventional
        AEC             AEC
                                      NOTE The minimum kV value that can be used in the
                                           AAEC mode is set at the factory to a value 20
                                           kV. If it needs to be adjusted contact your
                                           sales representative.
                                            To change the AEC modes press the automatic/
                                            manual exposure key so that the appropriate indicator
                                            light will come on. The exposure mode will change
                                            from the original setting to the new setting.
     14.3 Setting the oblique view angle
                                            The angle to which the C-arm will rotate when an
                                            oblique view is chosen can be changed to any angle
                                            between 15 ° and 75°.
                                            Press the control key to activate the secondary
                                CTL
                                            function mode. The indicator light will come on.
                                            Press the right oblique key to select the oblique view.
                                            The angle to which the C-arm will rotate will appear on
                   45        OBL
                                            the angle display and start to flash.
                                            Press the field/light keys to change the oblique angle.
                   55                       The new angle will appear on the display.
                                CTL         Press the control key to store the new oblique angle in
                                            the memory.
                                      NOTE A new oblique angle can be stored in the
                                           memory also by choosing an oblique view and
                                           rotating the C-arm with a C-arm control
                                           switch. However, angles between 15 and 29
                                           degrees are not stored.
User’s Manual                                                     Planmed Sophie Classic S 39
SPECIAL FUNCTIONS
      14.4 Posterior-anterior viewing angle
                                                       CC         Press and hold the cranio-caudal key for two seconds
                                                                  and the C-arm will rotate to the PA position.
        PA_position.eps
                                                                  The C-arm angle can be adjusted with the C-arm
                                          Tubehead away           controls. The C-arm can be rotated in the
                                          from the user           counterclockwise direction. The new angle will appear
                                                                  on the display.
                                                                  Note that the physical limits of the X-ray unit will not
                                                                  allow you to adjust the position of the PA position in
                                                                  the clockwise direction.
                                               Tubehead
                                               towards the user
                              C-arm rotation
                              switches
      14.5 Setting the speed of the compression paddle movement
                                                                  During compression the compression paddle moves
                                                                  downwards at two different speeds:
                                                                  - the maximum compression speed, no compression
                                                                  - the rate at which the speed decreases during the
                                                                  compression stage.
                                                                  These speeds can be adjusted.
                          The maximum compression speed
                                                                  Press the control key to enter the secondary function
                                                      CTL         mode.
40   Planmed Sophie Classic S                                                                               User’s Manual
                                                                          SPECIAL FUNCTIONS
                                           Press and hold the mAs down key to select the
                                           maximum compression speed range. The current
            1H=   daN         mAs
                                           speed number will appear on the time/force display
                                           and start to flash.
                                           Select the speed you require for the initial descent.
                                           The number 1 is the slowest speed and the number 6
                                           is the fastest speed.
                                     NOTE The setting 0 (zero) should and can be used
                                          only if the compression force measurement is
                                          inoperative. When the speed 0 is selected the
                                          force measurement is totally ignored.
                                          Compression starts at a moderate speed and
                                          continues only at crawling speed, after the
                                          compression movement is shortly interrupted
                                          by releasing the control switch.
                                           Press the control key again to accept the new initial
                               CTL         descent speed. The indicator light will go out.
           Compression speed decrease rate
                                           Press the control key to enter the secondary function
                               CTL         mode.
                                           Press and hold the mAs up key to select the rate at
                                           which the speed will decrease during the actual
                  2L=   daN   mAs
                                           compression stage. The current speed decrease
                                           number will appear on the display and start to flash.
                                           Select the speed decrease number you require. The
                                           number 1 is the slowest speed decrease and the
                                           number 6 is the fastest speed decrease.
                                           Press the control key again to accept the new speed
                               CTL         decrease number and exit the secondary function
                                           mode. The indicator light will go out.
     14.6 Adjusting the initial speed at which the C-arm moves up and
          down
                                           When adjusting the height of the C-arm it will move
                                           slowly at first and then accelerate. The speed at which
                                           the C-arm initially moves can be adjusted. If the
                                           maximum speed of the C-arm must be changed
                                           contact your local sales representative.
                               CTL         Press the control key to select the secondary function
                                           mode. The indicator light will come on.
User’s Manual                                                    Planmed Sophie Classic S 41
SPECIAL FUNCTIONS
                                         Press the extra key below the left lateral key and the
                                 extra
                  3 LL     daN
                                  key    initial speed at which the C-arm moves up and down
                                         will appear on the main display.
                                         Press field/light keys to adjust the speed of movement.
                                         The left key will decrease the speed (minimum 1) and
                                         the right key will increase the speed (maximum 6).
                                         Press the control key to accept the new speed and exit
                                  CTL    the secondary function mode. The indicator light will
                                         go out.
      14.7 Setting the stop limit of the compression force
                                         Press the control key to enter the secondary function
                                  CTL    mode. The indicator light will come on.
                                         Press and hold the left lateral key to select the
          10F=       daN          LAT    compression force setting mode. The current force, in
                                         decanewtons, will appear on the time/force display and
                                         start to flash. Note! The value is given in daN even if
                                         indicated as dN on some displays.
                                         Press field/light keys to select the stop limit of
                                         compression force. The minimum limit is 1 daN (2.2 lb)
                                         and the maximum limit is 20 daN (44 lb). When you
                                         reach the preset limit during compression you will hear
                                         a signal tone and compression will stop. Compression
                                         can be continued after this but only at fine-tuned
                                         speed.
                                         Press the control key again to accept the new stop
                                  CTL    limit for the compressive force and exit the secondary
                                         function mode. The indicator light will go out.
      14.8 Adjusting the volume of the exposure warning signal
                                  CTL    Press the control key to select the secondary
                                         functions. The indicator light will come on.
                                         Press and hold down the density down key until you
                                         hear the exposure warning signal.
                                         Press the field/light keys to change the volume of the
                                         warning signal.
42   Planmed Sophie Classic S                                                      User’s Manual
                                                                                SPECIAL FUNCTIONS
                                                Press the control key to accept the new or existing
                                   CTL          volume.
     14.9 Contrast/dose adjustment
                                          NOTE This parameter functions in the AAEC mode
                                               and in the AEC mode when the Automatic kV
                                               Selection function is ON.
                                                The kV value is automatically adjusted to give the
                                                optimum exposure time. If the kV is increased the mAs
                                                will decrease resulting in a lower radiation dosage and
                                                lower film contrast. If the kV is decreased the mAs will
                                                increase resulting in a higher radiation dosage and
                                                higher film contrast.
                                                If, when you are using this mode, you find that you
                                                want to increase the film contrast or lower the radiation
                                                dosage it can be done as follows.
                                                Press the control key to enter the secondary function
                                   CTL
                                                mode. The indicator light will come on.
                                                Press and hold the automatic/manual exposure key
                0cd   daN                       until the current contrast/dose setting appears on the
                                                time/force display and starts to flash.
                                                Press the field/light keys to change the setting of the
                                                contrast/dose. The enlargement will increase the film
                                                contrast, and the radiation dose (the mAs will increase
                                                and the kV will decrease) and the reduction key will
                                                decrease the film contrast and the radiation dose (the
                                                mAs will decrease and the kV will increase). The
                                                highest setting is +4 and the lowest setting is - 4.
                                                Press the control key to store the new contrast/dose
                                  CTL           setting into the memory. The indicator light will go out.
     14.10 Setting the correct time and date
                                   CTL
                                                Press the control key to select the secondary
                                                functions. The indicator light will come on.
                                                Press and hold the sensor key until the current time
                                  3 2 1
                13:22       daN
                                                appears on the time/force display. The minutes will
                                                start to flash.
                                                Press the sensor key repeatedly to step to the
                                                parameter(s) to be adjusted, the sequence is: minutes
                                                - hours - day - month - years - century.
                                                Press the field/light keys to change the setting of the
                                                selected parameter.
User’s Manual                                                          Planmed Sophie Classic S 43
SPECIAL FUNCTIONS
                                                   Press the control key to accept the new time. The
                                   CTL             seconds counter is zeroed. The indicator light will go
                                                   out.
      14.11 Density offset adjustment
                                             NOTE To perform this adjustment the AEC mode
                                                  must first be selected.
                                   CTL
                                                   Press the control key to select the secondary
                                                   functions. The indicator light will come on.
                                                   Press and hold down the density up key for 2 seconds.
                                                   Press the density up/down keys to set the display to
                  1                                the same value you had to use in the normal user
                                                   density compensation to achieve your own zero
                                                   density.
                                                   Press the control key to accept the new density offset.
                                   CTL             The indicator light will go out.
      14.12 Disabling Bucky grid movement
                                             NOTE Note that the grid movement is always forced
                                                  ON every time the X-ray unit is turned on.
                                                   Press the control key to select the secondary
                                       CTL         functions. The indicator light will come on.
                                                   Press and hold down the right field/light key for 2
                                                   seconds.
                                                   Press the field/light keys to change the setting. The
                                                   time/force display shows the current setting.
                                                   This message indicates that the grid movement is
                            0FFG         daN       disabled.
                                                   This message indicates that the grid movement is
                                0n G     daN       turned on.
                                   CTL
                                                   Press the control key to accept the new setting. The
                                                   indicator light will go out.
44   Planmed Sophie Classic S                                                                User’s Manual
                                                                            SPECIAL FUNCTIONS
     14.13 mA limit (on/off)
                                CTL         Press the control key to select the secondary
                                            functions. The indicator light will come on.
                               kV           Press and hold down the kV down key for 2 seconds.
                                            Use the field/light keys to change the setting. The time/
                                            force display shows the current setting.
                                            This message indicates that the mA limit is off. The mA
                       0FFc                 value is chosen to be the maximum allowed mA for the
                                      daN
                                            selected kV value.
                        0n c                This message indicates that the mA limit is on. The
                                      daN   maximum mA value that can be used is 80 mA.
                                            Press the control key to accept the new setting. The
                                CTL
                                            indicator light will go out.
User’s Manual                                                      Planmed Sophie Classic S 45
TRANSPORTING THE X-RAY UNIT
      15 TRANSPORTING THE X-RAY UNIT
                                               CAUTION The X-ray unit must only be transported
                                                       by qualified service personnel.
                                               CAUTION Never move the X-ray unit without first
                                                       driving it to the transport position.
      15.1 Preparing the X-ray unit for transportation
                                                            Remove the film cassette, compression paddle, Bucky
                                                            (or cassette holder) and disconnect the remote
                                                            exposure switch.
                                 Cover plate
                          Base
                                                      NOTE Detach the cover plate from the X-ray unit’s
                                                           base and insert the C-arm locking knob in
                                                           place before you drive the X-ray unit to the
                                                           transport position.
                                               CAUTION Note that the C-arm locking knob must be
                                                       rotated as far down as it goes so that the
                                                       locking stud just touches the knob when
                                                       you drive the C-arm down.
                                                CTL
                                                            Press the control key to enter the secondary function
                                                            mode. The indicator light will come on.
                                                CC
                                                            Press and hold the cranio-caudal key (about four
                                                            seconds) until the C-arm starts to rotate. The C-arm
                                                            will automatically rotate in a clockwise direction from
                                                            the operating position to the transportation position. At
        PA_position.eps
                                                            the same time the telescopic column will automatically
                                                            lower and then rise slightly. When the C-arm reaches
                                                            the transportation position it will stop moving.
                                                      NOTE Make sure that the foot controls are on the
                                                           floor and not on the base when you drive the
                                                           X-ray unit to the transportation position.
                                                            Press the C-arm down switch to drive the C-arm to the
                                                            lowest position.
46   Planmed Sophie Classic S                                                                          User’s Manual
                                                       TRANSPORTING THE X-RAY UNIT
                                     To start the C-arm moving again repeat the keying
                                     sequence described above.
                                     Switch the X-ray unit off with the on/off switch which is
                                     located on the base behind the fixed column and
                                     disconnect the X-ray unit from the power supply.
                                     Disconnect the foot controls.
                                     Remove the two cover plugs from the hood, insert the
                                     transportation handle into the two holes and tighten
                                     the holding screws.
                                     The Sophie Classic S X-ray unit is now ready for
                                     transportation. Support the cast base (not the metal
                                     cover) with your foot and pull the X-ray unit back, using
                                     the transportation handle, until it is on the
                                     transportation wheels. NEVER TRY TO MOVE THE X-
                                     RAY UNIT USING THE HANDRAILS OR CONSOLE
                                     ARMS.
                                     The X-ray unit can now be moved. Transport it with
                                     care. Do not bump the X-ray unit down steps or allow
                                     the tubehead assembly to hit anything. Never try to
                                     move the X-ray unit with the C-arm in any other
                                     position than the transportation position.
      Trans01.eps
     15.2 Setting up the X-ray unit after transportation
                                     When you reach the place where the X-ray unit is to be
                                     used support the base of the X-ray unit with your foot
                                     and lower the front of the X-ray unit gently on to the
                                     floor. Do not allow the X-ray unit to drop heavily on to
                                     the floor or you may damage the tubehead assembly.
                                     Adjust the support feet, which are under the base plate
                                     and rear part of the base, until the X-ray unit is stable.
                               NOTE It is recommended to bolt the X-ray unit to the
                                    floor.
                                     Make sure that the C-arm has enough room to rotate
                                     without hindrance.
                                     Observe any local or national radiation shielding
                                     requirements.
User’s Manual                                                Planmed Sophie Classic S 47
TRANSPORTING THE X-RAY UNIT
                                           Remove the transportation handle by unscrewing the
                                           two holding screws. Replace the two cover plugs.
                                           Connect the X-ray unit to the power supply and switch
                                           the X-ray unit on with the on/off switch which is located
                                           on the base behind the fixed column.
                                           The X-ray unit will carry out a self-test. When the X-ray
                                           unit is ready for use the time will appear on the time/
                            09:00    daN   force display.
                                           Press the control key to enter the secondary function
                                           mode. The indicator light will come on.
                                CTL
                                           Press and hold the cranio-caudal view key (about four
                                           seconds) until the C-arm starts to move. The C-arm
                                CC
                                           will rotate in a counterclockwise direction from the
                                           transportation to the operating position. At the same
                                           time the column will rise to a preset height, about three
                                           quarters of the maximum height. When the C-arm gets
                                           to the correct position it will stop moving.
                                           To start the C-arm moving again repeat the keying
                                           sequence described above.
                                           Remove the C-arm locking knob by turning it
                                           counterclockwise. You can then replace the cover
                                           plate in position.
                                           Connect the remote exposure switch to the X-ray unit.
                                           Make sure that the position from which exposures are
                                           to be taken is correctly shielded.
                                           Connect the foot controls.
                                           The X-ray unit is now ready for use.
48   Planmed Sophie Classic S                                                         User’s Manual
                                                                                          HELP MESSAGES
     16 HELP MESSAGES
           Help messages appear on the time/force display if a key that has no function is pressed, or if the
           function is not allowed for some reason. The help message disappears automatically when the
           key is released.
  CODE                      DESCRIPTION                                   CORRECTIVE ACTION
HE4        The cassette is not properly positioned into the   Make sure that the cassette is properly
           holder.                                            centered.
HE5        The cassette has not been removed since the        Remove the cassette and reload a new one.
           previous exposure (double exposure
           prevention).
HE11       The up/down movement of the X-ray unit is not      Release the paddle before driving the X-ray
           allowed during the compression of the breast.      unit.
HE13       The aluminum/rhodium filter is not allowed with Increase the kV setting if you want to use the
           kV settings lower than 30 kV/27 kV.             aluminum/rhodium filter.
HE14       The kV setting cannot be changed before you Reduce the mAs setting.
           reduce the mAs setting.
HE18       A higher mAs value is not allowed with the Decrease the kV setting first
           current kV setting.
HE19       AEC subgroup 3 cannot be selected in the spot Select AEC subgroup 1 or 2.
           mode.
HE20       This key functions only in the AEC mode.           Select the AEC mode with the automatic/
                                                              manual exposure key.
HE21       This key functions only in the manual exposure Select manual mode with the automatic/
           mode.                                          manual exposure key.
HE23       This key has no function together with the CTL Press the CTL key again.
           key.
HE24       The C-arm cannot be rotated with the C-arm Select a view or decrease the compression
           rotation switches when the compression force force.
           is more than 5 kg.
HE25       The error must be cleared first from the display. Press the CTL key.
HE26       This key has no function in the stereotactic       Remove the stereotactic system first.
           mode.
HE27       The exposure switch is still activated.            Release the exposure switch.
HE28       The C-arm is not allowed to continue to rotate Press and hold down one of the foot control
           without pressing the paddle up, the paddle switches to continue the movement of the C-
           down or the sheets in switch on the foot arm.
           control.
HE30       The Up/Down movement of the C-arm is not Remove the needle before repositioning the
           allowed in the stereotactic mode when the X-ray unit.
           needle is inserted.
HE31       In the stereotactic mode, the ST key is used Before the synchronized ST rotation, enter the
           only for the synchronized ST rotation stereotactic mode by selecting the correct
           (movement from ST1 to ST2 position).         view and driving the X-ray unit to the ST1
                                                        position.
User’s Manual                                                                Planmed Sophie Classic S 49
HELP MESSAGES
     CODE                   DESCRIPTION                                  CORRECTIVE ACTION
HE32        In the stereotactic mode, you cannot select the Before selection the view, drive the X-ray unit
            view before the X-ray unit has been driven to the upright position: press the CTL key,
            away from the ST position.                      press and hold down the ST key and press
                                                            the C-arm up switch on the foot control.
HE34        In the stereotactic mode, the C-arm is not Press and hold down the ST drive switch on
            allowed to continue to rotate without pressing the foot control. The patient may remain in
            the middle switch (ST drive) on the foot control position.
            during the synchronized ST rotation (movement
            from ST1 to ST2 position).
HE35        You cannot select the Automatic Paddle This feature can be set on with the special
            Release (& Cassette Ejection) function. system parameter 20 (in service mode).
HE36        You have to release the upper compression Press the compression release key and wait
            paddle before selecting the view.         until the compression paddle has reached its
                                                      highest position.
HE38        The upper paddle is below the magnification Remove the magnification table and drive the
            table.                                      compression paddle above the magnification
                                                        table mounting holes.
HE39        The AAEC mode is not allowed with current kV     Increase the kV setting first if you want to use
            setting.                                         the AAEC mode, or use the AEC mode.
            OR: A lower kV setting is not allowed in the
            AAEC mode.
HE40        The AAEC mode can not be used with the Select the molybdenum or rhodium filter.
            aluminium filter.
HE41        The AAEC mode is not allowed with the current Decrease the kV value first if you want to use
            kV setting.                                   the AAEC mode, or use the AEC mode.
50    Planmed Sophie Classic S                                                                  User’s Manual
                                                                            ERRORS AND ERROR MESSAGES
       17 ERRORS AND ERROR MESSAGES
                                                          If the X-ray unit malfunctions or you make a mistake
                                                          when using the equipment an error message will
                                                          appear on the time/force display.
                                                          Before taking any corrective actions, press the control
                                              CTL
                                                          key to clear the error code from the display.
ERROR           DESCRIPTION                                    CORRECTION
CODE
Er00            The exposure switch was released too           Clear the error code. Remove the partially
                early during the exposure.                     exposed film and process it in order to see
                                                               if it is properly exposed. If not, insert a new
                                                               film into the cassette.. Take another
                                                               exposure. Remember to hold the exposure
                                                               button down for the whole duration of the
                                                               exposure.
Er03            The Flex AEC sensor that has been              Clear the error code. Make sure that
                selected does not detect any, or enough,       nothing foreign is obstructing the radiation
                radiation.                                     beam. If not, either increase the kV value,
                                                               select a different AEC sensor or use the X-
                                                               ray unit in the manual mode.
Er04            The Bucky is not connected, the cassette is    Clear the error code. Reload the cassette.
                not properly positioned inside the Bucky, or   If the error remains, check the Bucky.
                there is a problem with the cassette
                sensors or cabling.
Er05            The cassette was not removed from the X-       Clear the error code. Remove the cassette.
                ray unit after the last exposure (double       If the error still remains, check the Bucky.
                exposure prevention).
Er09            No view selected.                              Clear the error code and select the correct
                                                               view.
Er10            The X-ray tube anode voltage (kV)              Clear the error code. Try to operate the X-
                overshoot.                                     ray unit again. If it does not work or if the
                                                               error appears frequently, contact your sales
                                                               representative.
Er11            X-ray tube anode voltage (kV) dropped          Clear the error code. Try to operate the X-
                suddenly.                                      ray unit again. If it does not work or if the
                                                               error appears frequently, contact your sales
                                                               representative.
Er12            X-ray tube cathode filament pre-heating        Clear the error code. Contact your sales
                voltages are not calibrated.                   representative.
Er13            X-ray tube anode current (mA) sudden           Clear the error code. Try to operate the X-
                peak.                                          ray unit again. If it does not work or if the
                                                               error appears frequently, contact your sales
                                                               representative.
Er14            AEC sensor(s) are not calibrated.              Clear the error code. Contact your sales
                                                               representative.
User’s Manual                                                                     Planmed Sophie Classic S 51
ERRORS AND ERROR MESSAGES
ERROR        DESCRIPTION                                    CORRECTION
CODE
Er15         Overexposure of the Flex AEC sensor, or        Clear the error code. Contact your sales
             failure in the currently selected AEC sensor   representative.
             during calibration.
Er16         AEC feedback signal open circuit, or AEC       Clear the error code.
             detector operation failure.                    This error occurs also if no compression is
                                                            applied before taking an exposure. In this
                                                            case apply compression.
                                                            Contact your sales representative.
Er17         Bias values were not set during calibration    Clear the error code. Contact your sales
             of the tubehead filament voltage (tube type    representative.
             E or F).                                       This error occurs only while calibrating
                                                            filament voltages.
Er18         The kV fine-adjustment parameter values        Clear the error code. Contact your sales
             in the TUBE CPU differ from the values in      representative.
             the REAR CPU.
Er20         Mirror motor time-out. The mirror              Clear the error code. Try to operate the X-
             mechanism does not reach the limit sensor      ray unit again. If it does not work or if the
             within the specified time.                     error occurs frequently, contact your sales
                                                            representative.
Er21         Filter motor time-out. The filter mechanism    Clear the error code. Contact your sales
             does not reach the limit sensor within the     representative.
             specified time.
Er22         Collimator motor time-out. The collimator      Clear the error code. Contact your sales
             mechanism does not reach the limit sensor      representative.
             within the specified time.
             OR:
             Cutter motor time-out. The cutter
             mechanism does not reach the sensor
             within the specified time.
Er24         Bucky motor time-out. The grid does not        Clear the error code. Make sure that the
             move or there is no signal from sensor         Bucky is properly locked in place.
             within the specified time.                     Contact your sales representative.
Er26         X-ray tube anode does not rotate properly,     Clear the error code. Should this error
             or a problem in the anode motor rotation       occur only occasionally, it is recommended
             sensing.                                       to perform the tube filament calibration.
                                                            Contact your sales representative.
Er27         Compression motor time-out. The                Clear the error code. Contact your sales
             mechanism does not reach the limit sensor      representative.
             within the specified time.
Er28         Compression force calibration failure, force   Error occurs only during calibration.
             signal out of range.
Er29         One of the keys on the control panel was       Remove the obstruction holding down the
             being held down as the X-ray unit was          key. Clear the error code. Should this error
             carrying out its self-test during start-up.    occur repeatedly, contact your sales
             OR: If all other displays are blank,           representative.
             communication to the control panel is
             faulty.
Er30         The X-ray tube anode voltage (kV) is           Clear the error code. Contact your sales
             missing, dropping during exposure, or it is    representative.
             lower than the setting.
52   Planmed Sophie Classic S                                                                       User’s Manual
                                                                               ERRORS AND ERROR MESSAGES
ERROR           DESCRIPTION                                        CORRECTION
CODE
Er31            The X-ray tube anode current (mA) is               Clear the error code. Contact your sales
                missing, dropping during exposure, or it is        representative.
                lower than the setting.
Er32            The X-ray tube anode current (mA) is               Clear the error code. Contact your sales
                higher than the setting.                           representative.
Er33            The X-ray tube filament voltage (V) is out of      Clear the error code. Contact your sales
                range.                                             representative.
Er34            The X-ray tube bias voltage (V) is out of          Clear the error code. Should this error be
                range.                                             repeated constantly, contact your sales
                                                                   representative.
Er35            The Mains-sync signal from the Rotation            Clear the error code. Contact your sales
                drive PCB (or Sync PCB) does not reach             representative.
                the TUBE CPU.
Er36            The REAR CPU detected an exposure that             Clear the error code. Should this error be
                was too long (>10sec) and terminated it.           repeated constantly, contact your sales
                                                                   representative.
Er37            Open circuit in the kV feedback signal.            Clear the error code. Contact your sales
                                                                   representative.
Er38            Open circuit in the mA feedback signal.            Clear the error code. Contact your sales
                                                                   representative.
Er39            One of the keys on the C-arm side control          Remove the obstruction that was holding
                panel was held down as the X-ray unit was          down the key. Clear the error code. Should
                carrying out its self-test during start up.        the error be repeated constantly, contact
                                                                   your sales representative.
Er41            The C-arm angle-, lift mechanism height,           Clear the error code. Run the respective
                or compression paddle position information         mechanism from end to end to restore the
                was wrong.                                         position information.
Er42            Faulty pulses from the C-arm motor                 Clear the error code. Contact your sales
                rotation sensor, or the motor rotates even if      representative.
                not commanded.
Er43            No pulses from the C-arm rotation motor            Clear the error code. Contact your sales
                rotation sensor, or the C-arm rotation motor       representative.
                does not rotate even if commanded.
Er45            The lift motor rotates even if not                 Clear the error code. Contact your sales
                commanded, or faulty pulses from lift motor        representative.
                rotation sensor.
Er46            No pulses from lift motor rotation detector,       Clear the error code. Contact your sales
                or the motor does not rotate even if               representative.
                commanded.
Er47            The mains frequency is out of range                Clear the error code. Contact your sales
                (45...75 Hz), or there is a failure in the         representative.
                frequency measurement circuitry.
Er48            Failure in the stepper motor of the                Clear the error code. Contact your sales
                stereotactic device, its control circuitry or in   representative.
                the rotation sensors.
Er49            The stereotactic device is not at the end          Clear the error code. Contact your sales
                position sensor, or there is a failure in the      representative.
                sensor.
User’s Manual                                                                        Planmed Sophie Classic S 53
ERRORS AND ERROR MESSAGES
ERROR        DESCRIPTION                                        CORRECTION
CODE
Er50         Tubehead assembly temperature sensor               Clear the error code. Contact your sales
             short circuit.                                     representative.
Er51         Tubehead assembly temperature sensor               Clear the error code. Contact your sales
             open circuit.                                      representative.
Er52         Filament voltage feedback open circuit.            Clear the error code. Contact your sales
                                                                representative.
Er53         Power supply heatsink temperature sensor           Clear the error code. Contact your sales
             short circuit.                                     representative.
Er54         Power supply heatsink temperature sensor           Clear the error code. Contact your sales
             open circuit.                                      representative.
Er55         C-arm rotation reference sensor failure.           Clear the error code. Contact your sales
                                                                representative.
Er57         The remote exposure switch was being             Remove the obstruction and clear the error
             held down as the X-ray unit was carrying         code. Should the error code reappear,
             out its self-test during start-up, or there is a contact your sales representative.
             failure (short circuit) in the exposure switch.
Er58         One of the foot control switches was being         Remove the obstruction and clear the error
             held down as the X-ray unit was carrying           code. Should the error code reappear,
             out its self-test during start-up, or there is a   contact your sales representative.
             failure (short circuit) in the foot control
             switch.
Er59         Failure in the internal emergency STOP             Clear the error code. Switch off the X-ray
             system.                                            unit. The unit must not be used. Contact
                                                                your sales representative.
Er60         The TUBE CPU internal ± 15VDC voltage              Clear the error code. Turn off the X-ray unit
             is out of limits.                                  for at least 30 seconds and turn it back on.
                                                                If the problem still occurs, contact your
                                                                sales representative.
Er61         Failure in the serial communication       Clear the error code. Contact your sales
             between the TUBE CPU and the REAR         representative.
             CPU, or non-compatible software versions.
Er62         Failure in serial communication between            Clear the error code. Contact your sales
             REAR CPU and an external test device.              representative.
Er63         Error in the STOP communication line               Clear the error code. Contact your sales
             between the TUBE and REAR CPUs.                    representative.
Er64         Error in the exposure communication line           Clear the error code. Contact your sales
             between TUBE and REAR CPUs.                        representative.
54   Planmed Sophie Classic S                                                                         User’s Manual
                                                                           ERRORS AND ERROR MESSAGES
ERROR           DESCRIPTION                                   CORRECTION
CODE
Er68            It is not allowed to press the paddle down    Check that there is nothing pressing the
                and paddle up switches on the foot control    switches down. If not, the most probable
                simultaneously.                               cause is a faulty foot control cable or
                                                              switch. Contact your sales representative.
Er71            Software chip (Flash-EEPROM) failure on       Clear the error code. Contact your sales
                the TUBE CPU.                                 representative.
Er72            Software chip (Flash-EEPROM) failure on       Clear the error code. Contact your sales
                the REAR CPU.                                 representative.
Er73            The REAR CPU attempted to execute an          Clear the error code. If the error occurs
                illegal program instruction.                  constantly, contact your sales
                                                              representative.
Er74            REAR CPU watchdog reset occurred.             Clear the error code. Contact your sales
                                                              representative.
Er75            REAR CPU illegal interrupt detected.          Clear the error code. Contact your sales
                                                              representative.
Er76            REAR CPU timer interrupt error.               Clear the error code. Contact your sales
                                                              representative.
Er77            REAR CPU stack overflow.                      Clear the error code. Contact your sales
                                                              representative.
Er78            The time-of-day clock oscillator (32768 Hz)   Clear the error code. Contact your sales
                is not oscillating or is out of tolerance.    representative.
Er79            TUBE CPU stack overflow.                      Clear the error code. Contact your sales
                                                              representative.
Er80            REAR CPU parameter memory (Flash-             Clear the error code. Contact your sales
                EEPROM) failure.                              representative.
Er81            TUBE CPU parameter memory (Flash-             Clear the error code. Contact your sales
                EEPROM) failure.                              representative.
Er82            The REAR CPU CONFIG register contains         Clear the error code. Contact your sales
                incorrect data.                               representative.
Er84            The REAR CPU parameter memory                 Clear the error code. Contact your sales
                (Flash-EEPROM) is empty or erased.            representative.
Er85            Flat battery on REAR CPU (RAM stand-by        Clear the error code. Contact your sales
                battery is drained or has failed).            representative.
Er86            The X-ray unit detected a brief drop in the   Clear the error code. The X-ray unit can be
                mains voltage, or error in detection          used.
                circuitry.
Er87            Illegal regional set-ups.                     Clear the error code. Contact your sales
                                                              representative.
Er 88           Battery back-up memory (RAM) is erased,       Clear the error code. Contact your sales
                or the content is not valid.                  representative.
Er 89           Incorrect type of C-arm rotation motor        Clear the error code. Contact your sales
                sensor in the Flash-EEPROM memory.            representative.
User’s Manual                                                                   Planmed Sophie Classic S 55
ERRORS AND ERROR MESSAGES
ERROR        DESCRIPTION                                 CORRECTION
CODE
Er91         Error in the stereotactic system sensor     Clear the error code. Contact your sales
             signals.                                    representative.
Er93         Error in the compression system end limit   Clear the error code. Contact your sales
             sensors (simultaneous signals from both     representative.
             end limit sensors).
Er94         Error in the C-arm rotation sensor system   Clear the error code. Contact your sales
             (simultaneous signals from the reference    representative.
             and/or limit sensors).
Er95         Error in the lift mechanism sensor system   Clear the error code. Contact your sales
             (simultaneous signals from both end limit   representative.
             sensors).
Er96         Error in the Bucky mechanism, in the        Clear the error code. Contact your sales
             sensor, or in the movement of the           representative.
             mechanism.
56   Planmed Sophie Classic S                                                                User’s Manual
                                                                                         MAINTENANCE
     18 MAINTENANCE
           The following maintenance work should be carried out.
     18.1 Daily check
           A test exposure, using a tissue equivalent test phantom or the Planmed calibration phantom,
           should be taken at least once a day to ensure that the AEC exposure and mAs and density
           values remain consistent.
           Check the condition of the film processing unit. Make sure that the chemicals used are fresh and
           that the processing times and temperatures are constant. Check the replenishment rate.
           Carry out a sensitometry test and keep a track on the measurements.
           Check the condition of the compression paddles, cassette holder, Buckys and magnification
           platform. These parts can become brittle (light parts and cracks) after prolonged cleaning with
           wrong type cleaning solutions.
     18.2 Cleaning
           Compression paddles, cassette holder, Buckys and magnification
           platform
           The compression paddles, cassette holder, Buckys and magnification platform must be cleaned
           as follows:
           • Clean the surfaces first using a mild soap solution and water.
           • Disinfect the surfaces with non-alcoholic disinfection solution. Planmed recommends
             Pharmaceutical Innovations Inc. M SPRAY 2000 disinfectant.
           Do not use any abrasive cleaning agents, mechanical cleaning methods or cleaning equipment.
           Do not immerse the parts in cleaning agent.
           Cassette eject switch
           The base of the cassette eject switch may gather grease. It should be wiped clean periodically.
           Other X-ray unit surfaces
           The X-ray unit surfaces should be periodically wiped with a soft cloth damped in cleaning
           solution.
     18.3 Servicing
           The following things must be checked once a year:
           Leakage radiation
           HVL measurement
           Linearity and reproducibility (also AEC)
           kV
           mAs
           Exposure time
           Automatic exposure control limits
           Illuminance of positioning light field
           Alignment of visually defined X-ray field and contrast of the light field
           X-ray field size
           Compression force
           Gap between cassette and Bucky or between cassette and cassette holder (max. 2 mm)
User’s Manual                                                                 Planmed Sophie Classic S 57
DISPOSAL OF THE X-RAY UNIT
      19 DISPOSAL OF THE X-RAY UNIT
           In order to reduce the environmental load over the product’s entire lifecycle, Planmed’s products
           are designed to be as safe as possible to manufacture, use and dispose of.
           Parts which can be recycled should always be taken to the appropriate processing centres, after
           hazardous waste has been removed. Disposal of obsolete units is the responsibility of the waste
           possessor.
           All parts and components containing hazardous materials must be disposed of in accordance
           with waste legislation and instructions issued by the environmental authorities. The risks involved
           and the necessary precautions must be taken into account when handling waste products.
           Rear Processor PCB 109-10-04 of the Sophie Classic S X-ray unit is equipped with a battery.
           Batteries must be disposed of following the requirements of Directive 2006/66/EEC and in
           accordance with waste legislation and instructions issued by the environmental authorities.
                          Disposal of Sophie Classic S Mammography X-ray unit
                         X = action, (X) = action in cases where processing is available
                                                                                      Hazardous
                                                                        Waste
                                  Main materials     Recyclable                         waste
                  Part                                                 disposal
                                   for disposal       material                        (separate
                                                                          site
                                                                                      collection)
           Frame and
           covers
           - metal                Aluminium,              X
                                  galvanized
                                  steel                   X
                                  lead                                                     X
           - plastic
                                  PVC,                                                     X
                                  PUR, UP                                  X
                                  other plastics          X
           - rubber                                                        X
           - glass                                        X
           Motors                                         (X)
           Component                                      (X)
           boards
           Cables,                Copper,                 X
           transformers           steel,                  X
                                  transformer oil                          X
           X-ray tube                                                                      X
           Packing                Wood,                   X
                                  cardboard,              X
                                  paper                   X
           Other parts                                                     X
58   Planmed Sophie Classic S                                                                       User’s Manual
                                                                      TECHNICAL SPECIFICATIONS
     20 TECHNICAL SPECIFICATIONS
           MANUFACTURED BY:
                      Planmed Oy
                      Asentajankatu 6
                      00880 Helsinki
                      Finland
           MODEL
                      Sophie Classic S
                      IEC safety class: I
                      IEC degree of protection: B
                      IEC enclosure class: IP20
           X-RAY TUBE ASSEMBLY
                      X-ray tube                     Toshiba E7290 or Varian M113SP
                                                     (Refer to the tubehead label)
                      Anode type                     rotating anode
                      Anode thermal capacity         300 000 HU
                      Target material                molybdenum
                      Tube port material             beryllium
                      Focal spot size                0.1/0.3 mm
                      Filtration                     0.5 mm Al/30 µm Mo
                                                     or
                                                     30 µm Mo/25 µm Rh (optional)
           GENERATOR ASSEMBLY
                      Generator                       constant potential, microprocessor
                                                      controlled, high frequency.
                      Anode voltage                   20 - 35 kV ±2 kV
                      Anode current - 0.3mm           E7290: 80 - 110 mA ±5 mA
                                                      M113SP: 91 - 120 mA ±5 mA
                      Anode current - 0.1mm           E7290: 21 - 35 mA ±1 mA
                                                      M113SP: 31 - 42 mA ±3 mA
                      mAs range                       E7290: 5-660 mAs
                                                      M113SP: 5-720 mAs
                      Exposure time - 0.3mm           0.1 - 5 seconds (optional 6 seconds) ±5%
                      Exposure time - 0.1mm           0.1 - 9.9 seconds ±5%
                      Cooling                         automatically controlled
                      Line voltage (standard version) 208 - 240 V~, 50 or 60 Hz - single phase
                      Line voltage compensation      automatic ±10%
                      Line voltage regulation        10%
                      Fuses                        2 x 15 AT / 250 V
                      Power consumption (standard) 100 VA, 4000 VA max. 5 seconds
                      Mode of operation           intermittent
                      Maximum apparent resistance
                      of supply mains             0.5 ohm
                      Maximum continuous
                      heat dissipation            250 W
           Complies with IEC 60601-1 and IEC 60601-1-2 EMC safety, and IEC 60601-2-28,
           IEC 60601-2-45 and IEC 60601-1-3 general and radiation regulations.
User’s Manual                                                           Planmed Sophie Classic S 59
TECHNICAL SPECIFICATIONS
           C-ARM
                      Rotation                      motorized, range -135°... +180°
                      Vertical movement             motorized range 750 mm... 1350 mm
                                                    (29.5 in... 53.1 in)
                      SID                           650 mm
                      Compression                   motorized
                      Cassette sizes                18 x 24 cm and 24 x 30 cm
                      Magnification                 1.6 and 1.8
           AUTOMATIC EXPOSURE CONTROL
                      Sensors                       three solid-state sensors
                      Density adjustment            15 density steps (13% change per step)
           MECHANICAL DATA
                      Dimensions (standard version) H x D x W: 985 x 900 x 755 mm minimum
                                                    (38.8 x 35.5 x 29.7 in)
                      Weight (standard version)     160 kg (352 lbs)
                      Colour                        RAL 9016
                      The Lift and C-arm rotation
                      motors’ operation             Intermittent operation. The ED is 8%,
                                                    25 sec “ON”, 300 sec “OFF”
           NOTE The technical specifications are subject to change without notice.
           NOTE Refer to Planmed Sophie Classic Technical Manual (788404) for the User’s
                Statement.
60   Planmed Sophie Classic S                                                               User’s Manual
                                                               LOCATION OF EQUIPMENT LABELS AND WARNING TEXTS
     21 LOCATION OF EQUIPMENT LABELS AND WARNING
        TEXTS
     Tube housing assembly
   Beam limiting device
                Note
                Transportation
                position
     OPTIONAL
     SFDA approval
      Caution
      service by
      qualified
                                    Sophie_label_pos_001.eps
      personnel only
    OPTIONAL
    CCC-approval
         OPTIONAL
         RoHs
                                                                                           OPTIONAL
                                                                                           Dangerous high voltage
                  Unit main plate                              Unit main plate
                                                               optional language version
User’s Manual                                                                                  Planmed Sophie Classic S 61
LOCATION OF EQUIPMENT LABELS AND WARNING TEXTS
                                                             Caution,
                                                             electric shock                          Total filtration
 OPTIONAL
 Warning electro magnetic radiation
     Warning, safety
     (both sides of the unit)
                                                                                                       Safety release
                                  sophie_label_pos_002.eps
                                                                         Image receptor support table
                                                                         (Label is placed below the lower shelf)
62     Planmed Sophie Classic S                                                                               User’s Manual
              Planmed Oy | Asentajankatu 6 | 00880 Helsinki | Finland
tel. +358 20 7795 300 | fax +358 20 7795 664 | 
[email protected] | www.planmed.com