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Sophie Classic Sophie Classic S User Manual PDF

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100% found this document useful (1 vote)
2K views68 pages

Sophie Classic Sophie Classic S User Manual PDF

Uploaded by

Paulo Portela
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 68

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

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