Performa

GE Healthcare

Operation Instructions

37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
 FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Copyright Code: 37094-IMG rev 3 Date: 10/2006

Copyright © 2000 by General Electric Company Inc. All rights reserved.

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Documentation, trademark and the software are copyrighted with all
rights reserved. Under the copyright laws the documentation may not be
copied, photocopied, reproduced, translated, or reduced to any electronic
medium or machine readable form in whole or part, without the prior
written permission of GE Healthcare.

The original language of this manual is English.

General Electric Company reserves the right to make changes in

specification and features shown herein, or discontinue the product
described at any time without notice or obligation. Contact your GE
representative for the most current information.

Manufactured by GE Healthcare Finland Oy

Kuortaneenkatu 2
FIN-00510 Helsinki
FINLAND
Tel. +358 10 394 6500
Fax. +358 10 394 6501

FOR TRAINING PURPOSES ONLY!

Internet and Service: http://www.gehealthcare.com/worldwide.html

GE Healthcare Finland Oy, a General Electric company, going to market as

GE Healthcare.

This manual applies to Performa units with software version 7.71a and up.
 FOR TRAINING PURPOSES ONLY!
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Table of Contents

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1 Introduction .............................................................................................................. 1
1.1 General .................................................................................................................................................................1
1.2 Radiation protection.......................................................................................................................................2
1.3 Conventions in this manual ........................................................................................................................3
2 Operation controls................................................................................................... 5
3 Operation procedure............................................................................................... 9
3.1 Preparations.......................................................................................................................................................9
3.1.1 Switching on the unit .................................................................................................................................... 9
3.1.2 Replacement of the accessories ............................................................................................................. 9
3.2 Selection of the technique factors........................................................................................................14
3.3 Automatic compression release............................................................................................................17
3.4 C-Arm adjustments......................................................................................................................................18
3.4.1 Vertical adjustment......................................................................................................................................18
3.5 Selection of the image angle...................................................................................................................19
3.5.1 Compression ...................................................................................................................................................19
3.5.2 X-ray field illumination light .....................................................................................................................20
3.5.2.1 Beam filter selection............................................................................................................................. 20
3.6 Patient positioning........................................................................................................................................21

FOR TRAINING PURPOSES ONLY!

3.6.1 ECS - Easy Compression System ..........................................................................................................21
3.6.2 Cranio-Caudal Projection..........................................................................................................................23
3.6.3 Latero-Medial Projection...........................................................................................................................25
3.6.4 Oblique Projection ........................................................................................................................................26
3.7 Exposure procedure ....................................................................................................................................27
3.7.1 Cassette insertion .........................................................................................................................................27
3.7.2 Making exposure...........................................................................................................................................27
3.7.3 Cassette removal..........................................................................................................................................28
3.8 Labeling and printer connection ...........................................................................................................28
3.9 Special exposures.........................................................................................................................................29
3.9.1 Magnification exposure .............................................................................................................................29
3.9.2 Implant exposure..........................................................................................................................................31
3.9.3 Biopsy .................................................................................................................................................................32
3.9.4 Spot exposure.................................................................................................................................................34
3.10 Transportation of Performa .....................................................................................................................35
4 Integrated Quality Control test ...........................................................................37
4.1 IQC with the sensitometry test film ......................................................................................................38
4.2 IQC by using phantom exposure ...........................................................................................................38
5 Problem situations.................................................................................................41
5.1 No power indication ....................................................................................................................................41
5.2 Ready light not lit ..........................................................................................................................................41
5.3 Grid lines............................................................................................................................................................41
5.4 Compression paddle stuck in upper position ..................................................................................41
5.5 Check and error conditions......................................................................................................................41
5.6 Performa Check code guide ....................................................................................................................42
5.7 Performa Error code guide.......................................................................................................................44
5.8 AEC adjustment quick fix guide..............................................................................................................45
5.9 Performa technique guide........................................................................................................................46

37094-IMG rev 3 GE Healthcare i

6 Specifications..........................................................................................................47
6.1 System specification model MGF-110 ................................................................................................47
6.2 User’s statement of model MGF 110 ...................................................................................................52

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6.2.1 Operating Parameters................................................................................................................................52
6.3 Tube loading chart for the M113SP tube...........................................................................................54
6.4 Electromagnetic Compatibility (EMC) tables ....................................................................................55
7 M113SP X-ray tube data sheets...........................................................................59
7.1 M113SP tube data sheet ...........................................................................................................................59
7.2 M113SP Filament emission charts........................................................................................................59
7.3 Anode heating and cooling curves.......................................................................................................60
7.4 Housing heating and cooling curves...................................................................................................60
7.5 Single load ratings........................................................................................................................................61
7.5.1 3 Ø Constant Potential 50 Hz ..................................................................................................................61
7.5.2 3 Ø Constant Potential 60 Hz ..................................................................................................................62
7.6 Description .......................................................................................................................................................63
7.7 General data ...................................................................................................................................................63
7.8 B-112 Housing................................................................................................................................................63
7.9 Filaments ..........................................................................................................................................................64
7.10 Stator 50/60 hz ..............................................................................................................................................64
7.11 Inherent filtration ..........................................................................................................................................65
7.12 Rayproofing .....................................................................................................................................................65

FOR TRAINING PURPOSES ONLY!

7.13 Focal spot measurement method ........................................................................................................65
8 System maintenance.............................................................................................67
8.1 Cleaning.............................................................................................................................................................67
8.2 Care .....................................................................................................................................................................67
8.3 Operators maintenance schedule ........................................................................................................68
8.4 Preventive maintenance schedule .......................................................................................................69
8.5 Quality assurance.........................................................................................................................................70
9 Graphical symbols used........................................................................................73

ii GE Healthcare 37094-IMG rev 3

 1 Introduction

1 Introduction

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1.1 GENERAL
Performa is a high quality x-ray mammography unit intended for both
screening and diagnostic examinations. The main features are the
rotating dual-angle anode tube, Tuned High Frequency (THF) generator
and easy positioning of the patient.

The vertical adjustment is motorized, and the C-Arm rotation angle ranges
from +135° to -180° degrees. The motorized compression of the breast is
controlled by pedals, and the manual compression by manual control. If
wanted, the compression can be released automatically after exposure. In
power failure the compression is released automatically.

The THF generator is integrated with the unit. The control panel can be
mounted on either side of the unit or on the wall of the examination room.
The exposure button can be situated beside the control panel or outside
the examination room.

The functions of the unit are controlled by a microprocessor, and the

operator is informed of error situations. For example, exposures without
cassette or too large diaphragm are prevented.

FOR TRAINING PURPOSES ONLY!

The Performa is intended only for mammographic examinations, no other
uses are permitted.

NOTE!
Move the foot pedals away from the working area to prevent any
unwanted activations of compression.

WARNING!
Never use the equipment if it is suspected that any electrical, or radiation-
emitting component is defective or inoperative.

WARNING!
Only trained, licensed persons are allowed to operate the Performa unit.

WARNING!
USE LIMITATION : External components: The use of accessories,
transducers, and cables other than those specified may result in
degraded ELECTROMAGNETIC COMPATIBILITY of the EQUIPMENT and/or
SYSTEM.

37094-IMG rev 3 GE Healthcare 1

1 Introduction

WARNING!
If you suspect any electro-magnetical interference affecting or caused by

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the unit, call service. Portable and mobile RF communications equipment
can interfere with operation of the medical electrical equipment.

Both cassette sizes, 18 x 24 cm and 24 x 30 cm can be used.

GE Healthcare accepts no responsibility for safety, reliability or the

performance unless:

– Assembly, calibration and repairs are performed by an GE

authorized representative according to corresponding Performa
manuals.
– Any modification, addition or deletion to this system is authorized
specifically by GE, in writing.
– Electrical installation complies with the IEC regulations.
– The system is used in accordance with Operating Instructions.

This device emits X-ray radiation for medical purposes. X-ray tube has
molybdenum anode. X-rays are molybdenum or rhodium filtered.
Minimum HVL 0,3 mmAl without compression paddle. Performa is CE-
marked in accordance with MDD (93/42/EEC). Performa fulfills the EMC

FOR TRAINING PURPOSES ONLY!

requirements of IEC 60601-1-2 2.ed.

1.2 RADIATION PROTECTION

As radiation is harmful to human body, the radiation protection
regulations of individual countries must be complied with. The user must
have a permission to use x-ray device for mammography. Radiation
protection means should be used. Prior to examination, it is
recommended to make sure that the doctor knows if the patient is
pregnant. If someone has to be close to the patient, protective clothing
must be used.

The optional RADIATION SHIELD must be used, or the unit must be

operated from a shielded control room (significant zone of occupancy is 2
meters). During the exposure, visual and audible contact should be
maintained with the patient. The free-standing radiation shield can be
positioned as required in the X-ray room. A mammography accessory
storage unit is available as an option and may be placed behind the free-
standing radiation shield.

CAUTION!
The maximum radiation that the system is capable of producing
corresponds to 5% of the typical CT-radiographic exposure. However, the
user should wear a dose recording device and follow local regulations for
radiation protection.

2 GE Healthcare 37094-IMG rev 3

 1 Introduction

1.3 CONVENTIONS IN THIS MANUAL

The manual has following conventions:

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NOTE!
Contains useful information for the reader about the unit and its use.

CAUTION!
Contains important instructions. If these instructions are not observed,
malfunction of the unit or damage to the unit or other property may
occur.

WARNING!
Contains warnings and instructions about the safety of the unit. If these
warnings are not respected, serious risks and injury may be caused to the
patient and operator.

FOR TRAINING PURPOSES ONLY!

37094-IMG rev 3 GE Healthcare 3

4
1 Introduction

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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 2 Operation controls

2 Operation controls

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11

FOR TRAINING PURPOSES ONLY!

Fig 2.1. The stand

1 X-ray tube 13 Spring for cassette locking

2 X-ray field illumination light 14 Toggle switch for vertical drive
control
3 Diaphragm selection lever 15 Button for C-Arm brake release
4 Face shield 16 Manual controls for compression
5 Compression thickness display 17 Hand grips
6 Compression force display 18 Rotation angle disc
7 Digital display of image angle 19 Control panel
8 Beam filter selection and 20 Exposure button
indication
9 Compression paddle 21 Indication of mains plug
(Illuminated if automatic fuse on)
10 Cassette holder 22 Mains switch
11 Automatic exposure control 23 Automatic fuse
detector (VectorPoint)
12 Detector position display 24 Compression force limit
(VectorPoint) adjustment
25 Emergency stop button (on both sides of the unit)

37094-IMG rev 3 GE Healthcare 5

2 Operation controls

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A B C D E
Fig 2.2. C-Arm display (A: Breast Thickness (cm), B: Compression force (N), C: C-Arm angle
(°), D: Filter, E: Filter selection)

FOR TRAINING PURPOSES ONLY!

Fig 2.3. Automatic exposure control detector (VectorPoint)

Fig 2.4. The ECS Pedal for compression and X-ray field illumination light switch

6 GE Healthcare 37094-IMG rev 3

 2 Operation controls

1 2 3

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4 5
6 7
9
8
14
12 13
10
11

Fig 2.5. Control panel

1 Ready indicator
2 Radiation indicator

FOR TRAINING PURPOSES ONLY!

3 Display of exposure time and error codes
4 kV selection
5 kV display
6 mAs selection
7 mAs display
8 Density selection
9 Density display
10 Grid and Bucky indicator, large focus
11 Magnification indicator, small focus
12 Button and indicator for automatic compression release
13 Button for selection of Auto-kV, Semi AEC or manual mode or
acknowledging error messages
14 AEC program indicators

NOTE!
When “grid” light is displayed, the large focal spot is selected. When
“magn” light is displayed, the small focal spot is selected.

37094-IMG rev 3 GE Healthcare 7

2 Operation controls

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1
2
3

FOR TRAINING PURPOSES ONLY!

Fig 2.6. The ECS cover buttons

NOTE!
In the Great Britain (GB) model toggle switch (2) and return button (3) are
functional only when compression is fully released.

1 Balance indicator (if illuminated the C-Arm is not in balance and the
C-Arm brake can not be released, press return button (3))

2 Toggle switch (2) for vertical movements of C-Arm and paddle

MINIMUM

3 Return button (Returns the C-Arm in the balance)

8 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

3 Operation procedure

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3.1 PREPARATIONS
3.1.1 Switching on the unit
! WARNING !
32458
When the light is on parts
Notice the warning label next to the power switch. Use the circuit breaker
of the system are energized located in the back of the carriage In order to switch the power off
although power switch is off. completely.
! ATTENTION !
Lorsque ce voyant est allumé, Switch the power ON using the mains switch. The timer display now
cela indique que certaines parties shows r.ES, kV display Pr, mAs display shows the software version and
du système sont sous tension bien que
l ' alimentation électrique soit coupée. density display shows the country code. Resetting must be acknowledged
by pushing the auto exp button, which starts the internal testing routine.

The power can be kept on between the examinations, but it is

recommended to keep the unit turned OFF from mains switch when not in
use. Switching ON and OFF restores the default settings on the control
panel. It is recommended to allow a warm-up period of approximately 3
minutes after the unit is switched on.

3.1.2 Replacement of the accessories

FOR TRAINING PURPOSES ONLY!

NOTE!
All accessories that the Performa manufacturer supplies for Performa are
suitable within the patient environment, unless otherwise indicated.

The following accessories are available for the unit (for more information,
refer to ACCESSORIES LIST 31581):

– 18 x 24 Semicircular diaphragm
– 18 x 24 cassette holders
– 18 x 24 Bucky devices

– 24 x 30 semicircular diaphragm
– 24 x 30 cassette holders
– 24 x 30 Bucky devices

– 10 x 24 cm compression paddle
– 21 x 24 cm compression paddle
– 21 x 24 cm XXL compression paddle
– 24 x 30 cm compression paddle
– 24 x 30 cm XL compression paddle for extra large breasts
– 24 x 30 cm XXL compression paddle for extra large breasts
– 21 x 20 cm compression paddle
– spot magnification tunnel (1.6 X)
– magnification kit (1.6 X, 1.8 X, 2.0 X and MammoSpot 1,6 X)
– magnification diaphragm
– magnification tunnel
– magnification compression paddle
– spot magnification compression paddle
– spot diaphragm
– spot kit for contact use
– biopsy and needle localization compression paddles

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3 Operation procedure

NOTE!
If the selected diaphragm is larger than the film, the exposure is

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prevented and a C.CO error code is displayed

The 18 x 24 and 24 x 30 cm rectangular diaphragms are integral parts of

the collimator.

The 18 x 24 cm rectangular diaphragm is selected by pushing the

diaphragm selecting knob towards the unit.

To select the 24 x 30 cm diaphragm pull the knob.

To install a special diaphragm, slide the plate into the groove in the
direction of the patient, and snap the plate into place. Refer to figure
below.

FOR TRAINING PURPOSES ONLY!

Fig 3.1. Selecting diaphragm and replacement of special diaphragm

Replacement of compression paddles:

Press down the compression paddle and pull it out.

10 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

Insert the desired paddle into the groove and push the paddle upwards
until it locks.

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Fig 3.2. Replacement of compression paddle

21x24 cm compression paddle

The 21x24 cm compression paddle is the

standard paddle used with the 18x24cm
film format with the bucky or cassette

FOR TRAINING PURPOSES ONLY!

tunnel.

It must not be used with the larger

24x30cm film and the corresponding
cassette holders because it does not
apply compression to the whole breast
being imaged, especially to the upper
quadrant of the breast in oblique and
lateral views.

24x30 cm compression paddle

The 24x30 cm compression paddle is

used with the large bucky or cassette
tunnel.

It applies compression to the whole

breast being imaged.

XL or XXL compression paddle

These paddles allow very thick breasts to

be positioned because those give
additional space in between the paddle
and the cassette holder: XL (+3cm) and
XXL (+5cm).

37094-IMG rev 3 GE Healthcare 11

3 Operation procedure

NOTE!
When using AA-mode with XL or XXL compression paddles, select higher

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kv than Performa automatically proposes.

20x21 cm compression paddle

The 20x21 cm compression paddle is

narrower than the standard 21x24 cm
paddle.

Therefore, during positioning it allows a

better access to a small breast.

In oblique or lateral views it allows a

better compression to breast if the size of
the axillary muscle does not allow the use
of the standard paddle.

It is important to remember, however, that especially in the oblique view

the axillary muscle is of interest because 45% of lesions are in the upper,
outer quadrant of the breast.

FOR TRAINING PURPOSES ONLY!

Replacement of cassette holders

Align the guides of the desired cassette holder with the grooves on the C-
Arm. Push the cassette holder to its position. The Bucky devices and
magnification tunnel are replaced in the same way.

Fig 3.3. Replacement of cassette holder

12 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

Exposures with the Bucky device

Install the Bucky device as shown in Fig. 3.3, Replacement of cassette

holder. The grid indicator will light up.

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Patient positioning and exposure techniques are similar to those
described in sections 3.6, Patient positioning and 3.7, Exposure procedure
When using the Bucky device kV-values must be 2-3 kV higher compared
to exposures with cassette tunnel.

A bucky is the most often used cassette

holder in mammography.

It has a moving grid inside which is to

reduce the amount of scatter radiation
reaching the film.

Primary radiation goes directly through

the breast and the grid and produces the
image of the breast on the film.

Scatter radiation has an arbitrary angle and thus produces no image on

the film but only reduces the contrast in the final image.

There is a separate bucky for both film formats 18x24 and 24x30 and for

FOR TRAINING PURPOSES ONLY!

both cassette types, normal cassette and daylight cassette.

Exposures with the Cassette tunnel

The purpose is to maximize the image quality by having the object to film
distance as short as possible which reduces blurring and by being able to
use a low kV-setting because of low attenuation in the cassette holder
itself.

The cassette tunnel, however, has no means of reducing the scatter

radiation to the film and this reduces the contrast considerably. Therefore
in many countries the cassette tunnel is not a recommended or not even
an allowed cassette holder.

There is a cassette tunnel for both film formats, 18x24 and 24x30 cm and
for both cassette types, normal cassette and daylight cassette.

NOTE!
See more information of accessories in section Special exposures.

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3 Operation procedure

Face shield

Face shield is used to keep patient’s face out of x-ray beam during
exposure.

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Face shield is installed by sliding it in along the grooves until the magnetic
lock is set. Remove the face shield by pulling it out along the grooves until
the magnetic lock is released.

3.2 SELECTION OF THE TECHNIQUE FACTORS

FOR TRAINING PURPOSES ONLY!

There are three modes of operation:

– Full automatic AEC (Auto-kV)

– Semi automatic AEC
– Manual mode

Select the mode with the button for automatic exposure button. The light
at the corner of the button indicates that the AEC operation is selected,
mAs display indicates AA if Auto-kV is selected and A if semi automatic
AEC is selected, refer to Fig.3.4, Control panel in Auto kV or semi AEC
mode.

A Operation in Auto-kV and in Semi AEC mode

In the Auto kV mode the exposure time and the kV are automatically
selected to produce an optimum image quality.

In Semi AEC mode only the exposure time is automatically selected to

produce an optimum image quality.

There are three preprogrammable stations for each automatic mode:

Station a: Default selection

Station b: Press once the AUTO EXP button
Station c: Press again the AUTO EXP button
1 As the factory default the system starts in AA mode, you need to
select semi AEC mode. Press AUTO EXP so many times that the mAs
indicator displays A. In this mode the exposure time is automatically
selected. The kV is manually selected.

For manual mode selection, press AUTO EXP so many times that the mAs
indicator displays a mAs value and the AUTO EXP light indicator turns off.

14 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

2 Select the kV with the kV selection buttons. If Auto kV is selected, the

kV is automatically selected.

In automatic modes the tube voltage range is 23 kV - 35 kV for large

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focus, 25 kV - 35 kV for small focus and 20 - 35 kV in manual mode for
both focal spots.

FOR TRAINING PURPOSES ONLY!

Auto kV Semi AEC
Fig 3.4. Control panel in Auto kV or semi AEC mode

NOTE!
In Michigan state mode the kV is limited to 34 kV

Select the Density with the density selection buttons. Use - Density for
lighter images, and + Density for darker images. Each step (nominal and
dependent on the phototimer calibration) decreases/increases the
exposure time by 10% (default, adjustable through software between 5%
- 20%). The range of correction is from -7 to +7.

The position of the phototimer detector can be adjusted from the knob
under the cassette holder. The detector location display indicates where
the detector is located corresponding to the breast. The semicircle on the
paddle indicates the size and location of the detector.

During exposure, the highest possible mA is automatically selected and

used to minimize the exposure time. The AEC terminates the exposure
when the correct amount of radiation has reached the film. The time
range is from 0.04 sec. to 5 sec. when using large focus (bucky, cassette
tunnel), and from 0.04 sec. to 10 sec. when using small focus
(magnification). The “magn” indicator light on the control panel displays
which image receptor device is attached to the system. When the
indicator light is lit, the system will automatically select the small focus.
When the “magn” light is not lit, the system is using the large focus.

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3 Operation procedure

NOTE!
For country code 12 (Great Britain) the time range is from 0.04 sec. to 6

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sec., and maximum mAs is 600 mAs.

NOTE!
In the New York version the maximum exposure time is the time that is
needed to achieve 300 mAs.

NOTE!
If a proper optical density could not be reached, even if maximum
exposure time would be used, the Exposure monitoring will terminate the
exposure in 50 ms. Select a higher kV and make a new exposure. CHANGE
THE CASSETTE.

B Operation in the Manual Mode

Fig 3.5. Control panel in the manual mode FOR TRAINING PURPOSES ONLY!

Select the mAs setting with mAs ± keys. Pressing the mAs+ button
increases the value and pressing mAs- button decreases the value as
shown in Table 3.1.

4 6 12 16 20
25 32 40 50 63
80 100 125 150 175
200 250 300 350* 400*
450* 500* 550** 600**
Table 3.1 Selection of mAs values

*, ** not allowed in N.Y. ** only allowed in G.B

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 3 Operation procedure

The maximum mAs-value is, however, limited by the selected kV and the
maximum permitted time. The maximum mAs/mA values are shown in
table 3.2, Maximum mAs/mA values depending on kV, focus size and
country code. Software version 7.71a..

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MGF 110 0.3 MGF 110 MGF 110
focus N.Y. 0.1 focus
0.3 focus

kV mAs/mA mAs/mA mAs/mA

20 350/75 300/75 250/25

21 400/80 300/80 250/26
22 400/85 300/85 250/28
23 450/90 300/90 300/30
24 450/95 300/95 250/29
25 500/100 300/100 250/28
26 450/95 300/95 250/27
27 450/90 300/90 250/26

FOR TRAINING PURPOSES ONLY!

28 400/85 300/85 250/25
29 400/85 300/85 200/24
30 400/80 300/80 200/23
31 400/80 300/80 200/22
32 400/80 300/80 200/21
33 350/75 300/75 200/21
34 350/75 300/75 200/20
35 300/69 300/69 200/20
Table 3.2 Maximum mAs/mA values depending on kV, focus size and country code.
Software version 7.71a.

3.3 AUTOMATIC COMPRESSION RELEASE

By pressing the automatic release button you can select or de-select the
automatic compression release immediately after an exposure. The light
at the corner of the button indicates that the automatic release has been
selected (default). De-select the feature for example when performing
manual biopsy.

NOTE!
The automatic release should be turned off during a needle biopsy
procedure.

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3 Operation procedure

3.4 C-ARM ADJUSTMENTS

3.4.1 Vertical adjustment

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The cassette holder vertical adjustment range is 40 cm - 144 cm (15” - 56”)
with the C-Arm in the upright position and 80 cm - 194 cm (31” - 76”) with
C-Arm at lateral position.

The vertical movement is motorized, and the control keys are placed on
both sides of the unit. There is a button also at the lower part of handle,
used when the C-Arm is tilted (The arrow towards the image receptor
indicates downward direction and the arrow pointing away from the
image receptor upward direction).

NOTE!
If country code 16 (Australia) is selected, vertical movement starts first
after compression fully released.

NOTE!
If country code 12 (G.B.) is selected, vertical movement is inhibited during

FOR TRAINING PURPOSES ONLY!

compression. Release the compression fully to enable vertical
movement.(in software version 3.21 and higher).

Fig 3.6. Toggle switch for vertical drive control

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 3 Operation procedure

3.5 SELECTION OF THE IMAGE ANGLE

The C-Arm rotates from +135° to -180° from the vertical position.

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Release the brake by pressing on of the release buttons and rotate the C-
Arm (figure 3.7, Selection of the image angle).

The image angle can be seen on the digital display (10) located on the C-
Arm and also at the scale ring at the C-Arm axle. The angles -135°, -120°, -
90°, -60°,-45°, 0°, +45°, +60°, +90° and +120° can be felt as détente points.
The C-Arm is locked when the button is released.

NOTE!
If country code 16 (Australia) is selected, compression is released when C-
Arm brake is released.

FOR TRAINING PURPOSES ONLY!

Fig 3.7. Selection of the image angle

3.5.1 Compression

A good image quality requires sufficient compression of the breast. The

breast is pressed against the cassette holder by the compression paddle.
The compression paddle can be moved with motor by pedals or by
manual controls.

The motorized motion of the compression paddle is controlled by pedals.

The downward arrow of the pedals indicates compression, and the
upward arrow indicates release (Fig. 2.4, The ECS Pedal for compression
and X-ray field illumination light switch).

The compression force limit for automatic compression can be adjusted

externally with the six-step selector. For safety reasons motorized
compression is limited in position 6, for example, to be 200N (44lbs)
according to the local demands.

37094-IMG rev 3 GE Healthcare 19

3 Operation procedure

Remember, care must be taken in order not to injure the breast. The
compressed breast thickness and the compression force is display in the
C-Arm display, refer to page 4.

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Manual compression controls are turned clockwise for compression and
counterclockwise for release (Fig. 3.8, Compression setting by manual
controls). As the manual controls allow considerable compression, up to
300 N (66 lbs.), care must be taken not to injure the breast.

The compression system incorporates also a mechanical force limit which

is adjusted to 300 N (66 lbs.) the factory.

FOR TRAINING PURPOSES ONLY!

Fig 3.8. Compression setting by manual controls

3.5.2 X-ray field illumination light

The x-ray field illumination light is switched on automatically when

pressing the downward compression pedal or pressing the x-ray field
illumination light switch. The figure of the light, next to the downwards
arrow indicates this. It is switched off automatically after about 40
seconds, x-ray field illumination light switch is pressed again or when the
exposure is initiated.

3.5.2.1 Beam filter selection

For large and dense breasts the Rhodium filter should be used to reduce
the exposure time and the patient dose. Manual selection of the filter
(selected from the filter button on the C-Arm) is default, but system can
be programmed to change the filter according the breast thickness. The
selected filter is indicated with a light next to the filter selection button
and on the control panel timer display when the unit is in ready position.

20 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

NOTE!
After the exposure the timer display shows the exposure time. After the

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cassette is removed from the cassette holder, the timer display indicates
which filter is in use. mo = Molybdenum filter (0.03 mm), rh = Rhodium filter
(0.025 mm).

NOTE!
When using the Rhodium filter do not increase the kV-setting.

3.6 PATIENT POSITIONING

NOTE!
Always advise the patient not to use deodorant prior to a mammogram!
Certain deodorants can mimic as microcalcifications on the film.

FOR TRAINING PURPOSES ONLY!

NOTE!
In case the patient moves in the middle of a procedure or compression
thickness is changed, in order to guarantee the accuracy of the
examination the procedure should be started from the beginning.

3.6.1 ECS - Easy Compression System

The ECS - Easy Compression System adds one more movement to the
mammography system: the direction defined by the image receptor and
the X-ray tube.

This movement is independent of the angle of the C-Arm, so it is different

from the normal up and down movement of the carriage.

The movements are controlled with

an ECS foot pedal.

After an exposure the autorelease

will drive both the compression as
well as the C-Arm.

The ECS uses the natural mobility of

the breast to increase the clinical
image quality and patient comfort.

The ECS makes it easier to elevate the breast and open the
inframammary fold. Therefore it maximizes the amount of breast tissue
visible in the image. In positioning the ECS will not replace the technologist
but helps her to do positioning more easily.

In clinical use the amount of images that have pectoral muscle visible in
cc-projections has increased from 20% (the amount prior to the use of the
ECS) to 50%.

37094-IMG rev 3 GE Healthcare 21

3 Operation procedure

The ECS is excellent in biopsies. If the lesion is close to the chest wall,
applying compression from down below ensures that the lesion stays
under the compression paddle. With standard compression the lesion
might may move away from underneath the paddle.

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1 C-Arm is driven up without compressing to open the inframammary
fold

2 The breast is compressed slightly with the paddle to hold it in place

FOR TRAINING PURPOSES ONLY!

3 Final compression is applied with the ECS from below

22 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

3.6.2 Cranio-Caudal Projection

1 Select the desired image size.
2 Load the film into the cassette and place the cassette into the

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cassette holder.
3 Turn the C-Arm to the upright position by pressing the image angle
release button so that the scale of image angle shows zero.
4 Adjust the cassette holder to a suitable height so that the nipple is in
profile and that no skin folds are present under the breast with the
vertical drive control. See figures 3.9, Correct vertical position and
3.10, Incorrect vertical position.

FOR TRAINING PURPOSES ONLY!

Fig 3.9. Correct vertical position Fig 3.10. Incorrect vertical position

5 Slightly rotate the patient medially leaning towards the stand. Refer
to Fig. 3.11, Patient positioning at cranio-caudal projection.
6 Allow the patient to grip with her arm under the cassette holder or
the hand grips, and lean towards the stand so that the cassette
holder under the breast is against the ribs.

Fig 3.11. Patient positioning at cranio-caudal projection

7 Place the breast on the cassette holder so that it is symmetrical and

totally covers the automatic exposure control detector, as illustrated
by one of the semicircles located on the compression paddle. Ensure
from the detector indicator that the breast covers the detector.

37094-IMG rev 3 GE Healthcare 23

3 Operation procedure

NOTE!
If the breast does not cover the detector or the breast has an implant,

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manual technique must be selected.

WARNING!
Keep focal spot to skin distances as large as possible in order to keep the
absorbed dose to the patient as low as reasonably achievable.

8 Set the compression with the pedal or the manual controls.

9 Take care that the nipple is not inverted. Smooth out any skin
wrinkles that may have been caused during compression.
10 Place the marker on the lateral aspect of the breast. Turn the
patient’s head away from the radiation beam.
11 Follow the compression thickness display to achieve proper
compression for both breasts. The breast should be firm when
palpated. The skin may become blushed, red or pink.
12 Make sure that the ready light is lit. Select or de-select the auto rel.

FOR TRAINING PURPOSES ONLY!

Fig 3.12. Cranio-caudal projection

13 Press exposure button to initiate an exposure, and keep it pressed

until the radiation indicator light is out and the audible sound is over.
Then release compression.
14 Change the cassette and make an exposure of the other breast or
move on to another projection.

24 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

NOTE!
kV selected should produce an exposure time from 0.5 to 2 seconds. If

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exposures are longer than 2 seconds, go up in kV. If they are shorter than
0.5sec., go down in kV.

3.6.3 Latero-Medial Projection

1 Select the desired image size.
2 Load the film into the cassette and place the cassette in the cassette
holder.
3 Turn the C-Arm to the lateral position by pressing the image angle
release button.
4 Adjust the cassette holder to a suitable height with the vertical drive
control. The woman presses her sternum against the edge of the
cassette table.
5 Ask the patient to hold the hand grip and to lean against the stand.
6 Place the breast on the cassette holder so that the breast totally
covers the detector of the automatic exposure control. In order to
achieve this, pull the breast gently away from the chestwall.
7 Check that the breast covers the detector.

FOR TRAINING PURPOSES ONLY!

8 Set the compression with the pedal or the manual controls. Make
sure that the nipple is in profile and no skin folds are present.

Fig 3.13. Latero-Medial projection

9 Check the auto rel and ready lights.

10 Press exposure button to initiate an exposure, and keep it pressed
until the radiation indicator light is out and the audible sound is over.
Then release compression.

37094-IMG rev 3 GE Healthcare 25

3 Operation procedure

3.6.4 Oblique Projection

1 Select the desired image size.
2 Load the film into the cassette, and place the cassette in the cassette

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holder. Turn the C-Arm to an angle of about 45°.
3 Adjust the cassette holder to a suitable height from the vertical drive
control. Place the upper edge of cassette so the axillary tail will be
visualized.
4 Ask the patient to hold the arm at a 90-degree angle and turn the
patient slightly to an oblique position. Rotate the patient towards the
cassette.
5 Place the breast on the cassette holder so that the breast totally
covers the detector of the automatic exposure control. Make sure
that the lateral tissue is pulled forward.
6 Check that the breast covers the detector.

FOR TRAINING PURPOSES ONLY!

Fig 3.14. Oblique projection

7 Set the compression with the pedal or with the manual controls.
Make sure that the nipple is in profile and that no skin folds are
present.
8 Check the ready and auto rel lights.
9 Press exposure button to initiate an exposure, and keep it pressed
until the radiation indicator light is out and the audible sound is over.
Then release compression.

26 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

3.7 EXPOSURE PROCEDURE

3.7.1 Cassette insertion

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1 Load the film into the cassette.
2 Push the cassette lock backwards to insert the cassette into the
cassette holder.
3 Slide the cassette in until the lock returns to the normal position.

Fig 3.15. Cassette insertion

3.7.2 Making exposure

FOR TRAINING PURPOSES ONLY!

The Ready Light indicates that the unit is ready for exposure. The
diaphragm, cassette holder and cassette must be in place.

After each exposure, there is a cooling period 10 - 50s depending on tube

loading. During this time an exposure cannot be made. If the exposure
button is pressed before this time is over, the timer display will indicate the
remaining cooling time.

If the Ready light does not turn on 50 seconds after an exposure, read
section 5.2, Ready light not lit.

NOTE!
Check that the proper filter is selected.

Press exposure button to initiate an exposure, and keep it pressed until

the radiation terminates. The radiation is indicated by the radiation light,
audible sound, and running exposure time on the control panel.

If the exposure button is released during the exposure, the exposure is

terminated and an “r.EL” error message is displayed on the timer display.

37094-IMG rev 3 GE Healthcare 27

3 Operation procedure

3.7.3 Cassette removal

Remove the cassette by pushing the cassette lock back from one side of
the cassette holder, and pushing the cassette from the other side.

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Fig 3.16. Removing the cassette

3.8 LABELING AND PRINTER CONNECTION

The Performa can output information to a printer. In this way, printed film
identification labels can be produced. One of two printer label sizes can be

FOR TRAINING PURPOSES ONLY!

selected by your service technician:

– 36.7 x 101 mm
– 26.0 x 101 mm

For each of the four rows printed, the last 15 characters of the 40 on each
row are freely programmable. The following is an example of the text
produced by Performa and printed on to a label:

1234567890123456789012345678901234567890
B Rh 0.02s 28kV 002mAs +0 HOSPITALxNAMEx
6.5cm 200N 180^/R 0.06mGy CODExxxxxxxxxx
15 / 08 / 00 R1 12345 RADIOLOGISTxxx
_________________________ DEPARTMENTxxxx

28 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

Explanation

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B Bucky / Cassette tunnel / Magnification
Rh Rhodium / Molybdenum filter
+0 Density correction
28kV kV
002mAs mAs
0.02s Exposure time
6.5cm Breast thickness
200N Compression force
180^/R C-Arm tilt angle, ^= degrees (°), to the /Right or
/Left
0.06mGy Average patient dose
15 /09 /04 Date of examination (day/month/year)
R1 Site of the detector (L1, L2, C1, C2, C3, C4, R1, R2)

FOR TRAINING PURPOSES ONLY!

12345 Exposure counter, up until 99999
The patient’s name must be handwritten after
_____________ printing the label

Printer is connected with a serial communication cable. Performa serial

port is located in the back of the unit, back cover bottom left.

Use digital film flasher to print the information permanently onto film.

3.9 SPECIAL EXPOSURES

3.9.1 Magnification exposure

By having the breast at a distance from the film causes the image to be
magnified. This increases the size of the smallest objects
(microcalcifications) above the grain size of the film-screen combination
thus improving the image quality.

Absorption in the air gap reduces scatter radiation thus further improving
the contrast. Good image quality requires a small focal spot though and
therefore a true 0.1mm focus is needed.

Although the object may be visualized well, this is offset by the fact that
only a small area of the breast can be imaged at a time. It therefore a
matter of opinion which magnification factor is used.

With the Performa system magnification factors 1.6x, 1.8x or 2.0x can be
used. The magnification is determined by the magnification stand. The
higher the factor is the larger the object is on the film but the area imaged
from the breast is smaller.

37094-IMG rev 3 GE Healthcare 29

3 Operation procedure

The magnification studies always use the smaller film format, 18x24. Both
cassette types, normal cassette and daylight cassette can be used.

The magnification studies can be done by applying compression to whole

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breast which gets imaged or by applying compression only to a specific
area, spot compression.

In the whole field imaging a larger area can be studied from one image,
for example when it is not quite sure where the area of interest is in the
breast.

Install the magnification tunnel as shown in Fig. 3.3, Replacement of

cassette holder. Remove the face shield.

The "magn" indicator

lights up and the
default technique is
selected
automatically.

Follow the general

patient positioning
procedure. The size of
the top of the
magnification tunnel

FOR TRAINING PURPOSES ONLY!

corresponds to the area which can be magnified onto the 18 x 24 film size.

If you are using magnification spot compression technique, be sure that

the area of interest is in the light field and the AEC detector is closest to
the patient and in the middle position.

The microfocus is automatically selected in magnification exposure.

Spot compression, on the other hand, applies local compression to a

particular area. This moves the different tissue structures better from
hiding each other.

It also compresses the breast to thinner from this region, thereby allowing
the use of lower kV-setting resulting in a better image quality. Positioning
using the spot compression is more difficult though.

Magnification diaphragm, Magnification spot

18x24 diaphragm, 18x24

When using the whole film area the magnification diaphragm on the left
has to be used. When using the spot compression the same diaphragm
can be used or the specific spot diaphragm, on the right, can used.

30 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

The spot diaphragm collimates the

image area to about 12cm in
diameter. This reduces scatter
radiation to the image area improving

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contrast and also the patient dose.

However, the final image may be

harder to look at on the viewing box
due to the density difference between
the image and the unexposed area.
Magnification spot diaphragm
If film marking needs to be used when for film marking
performing a spot compression, a
special diaphragm with an opening may be used.

Spot compression can be further

enhanced by using the spot
magnification tunnel.

It allows the same kind of effect in

compression but also from below the
breast, not only from the compression
paddle.

The benefits are the same, increased

FOR TRAINING PURPOSES ONLY!

local compression enhancing tissue
visualization and improved contrast
because a lower kV setting can be used.

3.9.2 Implant exposure

The implant paddle gives a very good

access to the breast during positioning.

The paddle can be best utilized with small

breasts, with breasts that have a silicon
implant or with male breasts.

It also allows good compression in oblique

or lateral views, because it extends to the
whole width of the small film format.

In regions where women usually have

small breast the implant paddle may be
used a standard paddle together with the 21x24 paddle.

The paddle can be used with a standard diaphragm which exposes the
whole film or with the special diaphragm which exposes only the
compressed part of the breast.

NOTE!
If the breast does not cover the detector or the breast has an implant,
manual technique must be selected.

37094-IMG rev 3 GE Healthcare 31

3 Operation procedure

3.9.3 Biopsy
1 Select the image size required and the corresponding diaphragm.
2 Attach the biopsy compression paddle.

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3 Clean the compression paddle and breast area carefully. If the Laser
guide is used, read the separate operation instructions.

CAUTION!
Do not use automatic release. Press AutoRel so that the indicator is “off”.

4 Turn the C-Arm to the cranio-caudal position by pressing the image

angle release button. The indicator for image angle shows zero.
5 Make the patient comfortable in the sitting position. Adjust the
cassette holder to a suitable height with the button for vertical drive
control.
6 Place the breast on the cassette holder so that the breast totally
covers the detector of the automatic exposure control. Turn the
patient’s head to the side. Set the compression with the pedal or
manual controls.
7 Take care that the nipple is in profile and no skin folds are present. Do
not compress the breast as tightly as in a routine exam since it must

FOR TRAINING PURPOSES ONLY!

remain compressed until the film is developed. Be sure to keep the
patient’s head out of the light field.
8 Press exposure button to initiate an exposure and keep it pressed
until the radiation indicator light turns off and the audible sound
stops. Do not release the compression.

NOTE!
In case the patient moves in the middle of a procedure or compression
thickness is changed, in order to guarantee the accuracy of the biopsy,
new image should be taken or the procedure should be started from the
beginning.

9 Develop the film. The holes in the compression paddle can be seen
on the image, and localization of the biopsy target can be made.
Perform the biopsy and release the compression.

Fig 3.17. Optional biopsy / needle localization paddles

Biopsy paddles are used in manual biopsy for Fine Needle Aspiration (FNA)
or lesion marking.

32 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

In the FNA a sample of the breast tissue is

taken for cytolocigal analysis of the
lesion. In lesion marking the lesion
marked for surgical biopsy either with a

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steel wire or with carbon or a dye (color).
The surgeon then follows either the wire
or color trail to remove the correct lesion.

In a procedure the breast is imaged with

a biopsy paddle from one projection.

The openings from the paddle can be seen in the image and with their
help the location of the lesion in this plane can be estimated. How deep in
the breast the lesion is can be estimated from images that have been
taken using another projection. These can be taken earlier or during the
same procedure.

NOTE!
Continued tapping of the footswitch is improper usage of the automatic
compression. Use the light switch to turn the collimator light on.

The needle is inserted into the breast after careful estimation and another

FOR TRAINING PURPOSES ONLY!

image is taken to ensure proper localization.

When localizing a steel wire, it correct localizing can be imaged after

insertion using another view. If this is done, the amount of compression
has to be little to make sure that the wire does not move.

There are three kinds of biopsy paddles available with different openings,
holes with diameter of 18mm, holes with diameter of 9mm and a square
opening of size 50x90mm. Which one to use is decided by the doctor’s
preference.

For localization use the biopsy paddle can have a fast release arm which
makes it easier to remove the paddle while the localizing wire is left in the
breast.

When inserting the needle into the breast the cross hair diaphragm can
be used to help the insertion.

37094-IMG rev 3 GE Healthcare 33

3 Operation procedure

The cross hair diaphragm has two

perpendicular steel wires that can be
moved within the diaphragm opening to
cast a cross shadow from the collimator

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light onto the breast.

When doing manual biopsy with a biopsy

paddle the location of the lesion is
observed from the film.

The location is seen with respect to

the openings of the paddle.

The collimator light is turned on

and the shadow from the steel
wires is then moved to the
corresponding location on the
paddle.

The needle tip is first placed to

place where the cross hair shadow
is on the skin. Keeping the shadow
then positioned to the other end of
the needle while inserting the needle into the breast makes sure that the
needle is following the same angle as the x-rays. This removes at least

FOR TRAINING PURPOSES ONLY!

one uncertainty when inserting the needle manually.

Marking the lesion

NOTE!
Release compression manually so that the hub of the needle does not
catch on the localizer paddle.

The spot of the lesion is marked with steel wire. It is recommended to use
the fast release needle localization paddles. The location of the wire end is
checked with a new exposure. If needed, the location of the wire is
changed and controlled with another exposure. Fix the control wire to the
breast with tape.

3.9.4 Spot exposure

The spot compression paddle is used in clinical

studies with bucky or cassette tunnel. It applies
local compression to a specific area in the
breast.

This moves the different tissue structures from

hiding each other giving a better visualization.
The breast tissue at the compressed area is also
thinner allowing the use of a lower kV setting
which gives a better contrast.

Spot compression
paddle (straight arm)

34 GE Healthcare 37094-IMG rev 3

 3 Operation procedure

Normally the whole film is exposed to make it easier to read on the light
box. However, if desired the x-ray field can be collimated to a smaller
area. This reduces the patient dose because only a part of the breast gets
radiation. Also, the contrast is improved because the amount of scatter

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radiation is reduced. However, films exposed this way are more difficult to
read because of the large unexposed area.

Certain diaphragms have an additional opening for

use with a film marker.

1 Select image size 18 x 24. Insert the cassette,

spot diaphragm and compression paddle.
2 Turn the C-Arm to the proper angle for the
projection to be performed.
3 Adjust the cassette holder to a suitable height with the button for
vertical adjustment.
4 Place the detector of the automatic exposure control closest to the
patient and be sure that the exposed area is under the paddle and
that it covers the AEC detector.
5 Adjust the compression with the pedal or manual controls. Smooth
out any skin wrinkles that may have occurred during compression.
Turn the patient’s head out of the light field.
6 Press exposure button to initiate an exposure, and keep it pressed

FOR TRAINING PURPOSES ONLY!

until the radiation display indicator light turns off and the audible
sound stops.

NOTE!
Care must be taken not to overcompress the breast and risk injury to the
patient.

3.10 TRANSPORTATION OF PERFORMA

If the mammography system is transported in a car or longer distances,
the C-Arm has to be removed. The carriage does not tolerate the
additional stress from such transportation.

37094-IMG rev 3 GE Healthcare 35

36
3 Operation procedure

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
 4 Integrated Quality Control test

4 Integrated Quality Control test

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The Performa has the Integrated Quality Control test to maintain the
optical film densities the same even if the film processor conditions have
changed.

Performa can correct the exposure times up to ±40%, (±25% in Germany)

whereafter the unit gives the CPS error code (Check the film processing
system).

The IQC can be done in two ways:

1 Reading density of the film processor sensitometry film (no exposure

with Performa)
2 Taking a phantom exposure with Performa and reading the film
density thereof.

Which method of IQC is used is determined in the setup of the Performa

by the service technician.

NOTE!

FOR TRAINING PURPOSES ONLY!

Always use the same cassette for IQC, set the detector in the same
position and read the O.D. from the same place of the exposured film.

Entering the program

The IQC-mode can be entered from the Performa by first selecting the
Auto kV mode (AA) or Semi AEC mode (A) and then pressing the +mAs-
button for three seconds in the Performa control panel.

NOTE!
The compression paddle drives automatically to the upper limit. This is to
prevent exposures to a patient.

The timer display indicates iqc for one second. Then for about two
seconds the correction factor from the previous IQC procedure is shown
and thereafter the text iqc shows up again.

The mAs display shows the optical density value that is followed either the
sensitometer method or the test exposure method.

NOTE!
If the compression paddle is not in the upper limit, the exposures are
inhibited, the iqc display starts to blink and paddle drives up again.

37094-IMG rev 3 GE Healthcare 37

4 Integrated Quality Control test

4.1 IQC WITH THE SENSITOMETRY TEST FILM

1 Expose a film with the sensitometer and process the film to get the
stepwedge on the film as below:

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2 Read the optical density from the step that has been selected during
the installation.
3 Select Auto kV mode (AA) or Semi AEC mode (A). Press the +mAs
button for three seconds. Enter the measured optical density by
using the +/- density buttons. Press Autoexp-button to enter the
value.

The time display shows the calculated correction whereafter the system
returns to normal mode and is ready for use.

4.2 IQC BY USING PHANTOM EXPOSURE

1 Select Auto kV mode (AA) or Semi AEC mode (A) and press on the
+mAs button for three seconds.

FOR TRAINING PURPOSES ONLY!

NOTE!
Performa selects the filter that has been programmed as default filter
when switching on the unit.

The mAs display in the Performa control panel shows the text “P.HA” to
indicate the use of a phantom.

The actual thickness of the acrylic phantom is not important as long as

the same phantom is always used. If the user does not have any
particular phantom to use and uses plain acrylic, thickness from 40mm to
60mm is recommended.

Placing the acrylic phantom

Place the phantom onto the cassette holder (Bucky). Having the acrylic
overlapping makes sure that no stray radiation hits the detector.

1 Acrylic/Mammographic phantom
2 Cassette holder top
3 Cassette
4 Image receptor
5 Detector

If a mammographic phantom (lower image) is used (for example RMI 156),

place it flush with the cassette holder edge. This is necessary to visualize
all objects in the phantom.

38 GE Healthcare 37094-IMG rev 3

 4 Integrated Quality Control test

However, if the IQC results vary from

procedure to procedure, check that
the phantom does not let direct
radiation to the detector: the

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
phantom may have moved inwards
from the cassette holder edge. Check
also the placement of the detector.

Test exposure

Make an exposure, develop the film

and read the optical density. Read
always the optical density from the
same place of the exposured film. At
this stage it is possible to go out from
the program by pressing the
Autoexp-button.

Programming the measured optical

density

Feed the measured optical density to the unit with the +/- DENSITY
buttons. The Performa unit selects 1.30 as default value, but the value can
be reprogrammed by the service technician.

FOR TRAINING PURPOSES ONLY!

Press Autoexp. The unit is now recalibrated to produce images with the
wanted optical density. The new correction factor will be displayed on the
timer display for 2 seconds, after that the Performa automatically returns
to the mode from where the System Control mode was entered.

The optical density will be ±10% within the wanted value.

After the IQC test, verify that the phantom image O.D. lies within the
country-specific limits, e.g. 1.60 ±0.15.

37094-IMG rev 3 GE Healthcare 39

40
4 Integrated Quality Control test

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
 5 Problem situations

5 Problem situations

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
5.1 NO POWER INDICATION
A Check that power cord and display cable are connected.
B Check that the mains switch is switched on.
C Check the fuses or the circuit breaker
D If not cleared, call service.

5.2 READY LIGHT NOT LIT

Depress the exposure button, and observe the text shown in the timer
display and refer “Check code guide” on the next page.

5.3 GRID LINES

If the grid light on the control panel is not lit, check that the Bucky is
properly attached on the cassette holder base. Exposure time too short
(shorter than 0.2 sec.). Lower the kV to extend the exposure time.

FOR TRAINING PURPOSES ONLY!

5.4 COMPRESSION PADDLE STUCK IN UPPER POSITION
Compression has driven in upper position with high speed after power
failure. Release compression by turning manual control handwheel
clockwise hard enough.

5.5 CHECK AND ERROR CONDITIONS

The Ready light indicates that every part of the unit is ready for exposure.
If the light is not on within 50 seconds after the previous exposure or the
light is blinking, an error condition has been detected.

Error conditions are indicated by a code on the timer display.

There are two groups of codes:

Check codes indicated by C.xx. Check codes indicate conditions that can
be handled by the operator.

Error codes indicated by E.xx. Most error codes require a call to the
service personnel.

All possible conditions and the action required by them are listed on
tables 5.1, Performa check code guide, 5.2, Performa error code guide and
5.3, Performa AEC adjustment quick fix guide.

37094-IMG rev 3 GE Healthcare 41

5 Problem situations

5.6 PERFORMA CHECK CODE GUIDE

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Check code in Reason for error Corrective action
timer display

C.CA The film cassette is not Insert or replace the film

inserted or has not been cassette.
replaced since the
previous exposure.
C.CH The cassette holder is Install or re-attach the
not installed or fully cassette holder.
engaged.
C.CO The diaphragm is not Push the diaphragm
properly in place or has lever properly in place
wrong size for the film or re-attach the
format. diaphragm in
collimator. Use the right
diaphragm.
C.dE The technique selected Press AutoExp to clear
resulted in too short an the error code.

FOR TRAINING PURPOSES ONLY!

exposure time. The Decrease the selected
detector was not fully kV and/or reposition the
covered by the breast. detector.
O.Fl Back-up timer. The Press AutoExp to clear
technique selected the error code. Increase
resulted in too long an the kV and/or reposition
exposure time or the the detector.
detector is covered by
other tissue than breast
tissue.
O.Fl and flashing Exposure terminated Press AutoExp to clear
kV-display early because the error code. Increase
calculated exposure the kV and/or reposition
time would have the detector.
exceeded the back-up
time with the selected
technique.
r.EL The exposure button Press AutoExp to clear
was released too early. the error code.
r.ES The system has reset. Press AutoExp to re-
initialize the unit.
U.FL Direct exposure to the Press AutoExp to clear
cassette holder or the error code. Check
radiation is totally the object and/or the
blocked to the detector. diaphragm. Increase kV.
Table 5.1 Performa check code guide

42 GE Healthcare 37094-IMG rev 3

 5 Problem situations

Check code in Reason for error Corrective action

timer display

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C.bU The bucky grid is not in Switch the unit off and
starting position. on, re-attach the bucky.
If the code re-occurs
call for service.
C.Cn The bucky grid is not Switch the unit off and
moving properly. on, re-attach the bucky.
If the code re-occurs
call for service.
C.ES The exposure switch Switch off the power.
was pressed when the Check the exposure
power was turned on. switch and turn on the
power.
C.PS IQC system limit Call for film processor
reached. service.
C.br Brake released during Check that patient has
exposure. not pressed the brake
release button.

FOR TRAINING PURPOSES ONLY!

Table 5.1 Performa check code guide

37094-IMG rev 3 GE Healthcare 43

5 Problem situations

5.7 PERFORMA ERROR CODE GUIDE

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Error code in Reason for error Corrective action
timer display

E.r1 Error in EPROM. Press autoexp/call service.

E.r2 Error in EEPROM. Turn OFF/ON, call service.
E.r3 Error in ext.RAM. Turn OFF/ON, call service.
E.r4 Eprom error in C-Arm. Call Service.
E.r5 EEprom error in C- Call Service.
Arm.
E.01 mA too low. Turn OFF/ON, call service.
E.02 No kV. Turn OFF/ON, call service.
E.03 X-ray tube too hot. Wait 20-45 min, try making
exposure. Call service.
E.04 Error in serial Turn OFF/ON, call service.
communication.

FOR TRAINING PURPOSES ONLY!

E.05 Limit counter. Call Your distributor.
E.06 PC communication Call service.
problem.
E.07 Anode not rotating. Turn OFF/ON, call service.
E.08 Breast thickness Turn OFF/ON, call service.
measuring problem.
E.09 Filter not in the right Check filter selection
position. mechanics.
E.10 Compression force Drive compression to upper
measurement error. limit and then drive it down.
Call Service.
E.11 C-Arm angle Call Service.
measurement error.
E.12 Internal Call Service.
communication error.
S.YS CPU error. Turn OFF/ON, call service.
t.oF Motor time out error. Turn OFF/ON, call service.
E.AF Communication error Turn OFF/ON, call service.
CPU - AEC.
Table 5.2 Performa error code guide

44 GE Healthcare 37094-IMG rev 3

 5 Problem situations

5.8 AEC ADJUSTMENT QUICK FIX GUIDE

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AEC adjustment quick fix guide

Problem Probable reason Ask service to do Comments

No contrast Full AEC kVs with Increase the Results in

with large large breasts too Target time with lower kV
breasts high. large breast with large
thickness. (Pr# 65 breasts.
tAr program)
No contrast Full AEC kVs with Increase the Results in
with small small breasts too Target time with lower kV
breasts. high. small breast with small
thickness. (Pr# 65 breasts.
tAr program).
mAs too high, Full AEC kVs low Decrease the Low kVs
long exposure Target time yield long
times values mAs
O.fl errors or Start kV too low Change the full

FOR TRAINING PURPOSES ONLY!

“white images” and/or AEC kV table (Pr#
maximum 64 SUP
allowable kV parameter E) or
change too Increase the kV
small. change value (Pr
mode)
EAf errors Poor connection Check the
between CPU cabling. Adjust
and AEC boards. the AEC board
Incorrectly offset voltages.
adjusted AEC
offset voltages.
EAf error at AEC board Check the AEC
start up supply voltages board supply
problems or voltages. If you
autozeroing are using the
circuit does not 32315 AEC board
work at start up. with software
7.27 or later, you
can remove the
capacitor C35
(22µF)
“white images” O.fl, U.fl or C.cn Check the bucky
error code connection
(apply
compression)
Table 5.3 Performa AEC adjustment quick fix guide

37094-IMG rev 3 GE Healthcare 45

5 Problem situations

5.9 PERFORMA TECHNIQUE GUIDE

SemiAEC, Mo/Mo or Mo/Rho

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Film:Kodak Min R 2000, Screen: Kodak Min R 2000 and Min R 2190
Film: Fuji AD-M, Screen: Fuji AD Mammo Fine
Film: Agfa HDR and HDR-C, Screen: Agfa HD and HD-S

Compressed breast Technique

thickness
kVp Filter Density

< 3 cm 23 Mo 0
4 - 5 cm 24 - 26 Mo 0
6 - 7 cm 27 - 29 Mo or Rh* 0
> 8 cm 30 - 32 Mo or Rh* 0

Manual Techniques mAs kVp

Small breasts 16 - 40 23 - 25

FOR TRAINING PURPOSES ONLY!

Implants 80 - 175 26 - 29
Specimens (non-mag and mag) 4 - 16 20 - 23
Table 5.4 Performa technique guide

NOTE!
Implant displaced views and specimens may be phototimed if sufficient
breast tissue covers the photocell closest to the chest wall.

Comments:
1 Maintain exposure times between 0.5 and 2.5 seconds. Decrease kVp
if times are less than 0.5 seconds and increase if they are more than
2.5 seconds.
2 If exposure times are within indicated times, use + or - density
settings to achieve optimal film density.
3 Your technique may vary from those indicated above depending on
film density preferences, processor or film irregularity, or different
film/screen combinations.
4 *Rhodium - use for very dense breasts, 6 cm or greater. No need to
increase kV.
5 Magnification views - increase technique by 2 - 3 kVp, if exposure
time exceeds 5 seconds.

46 GE Healthcare 37094-IMG rev 3

 6 Specifications

6 Specifications

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
6.1 SYSTEM SPECIFICATION MODEL MGF-110

System specifications model MGF-110

Manufacturer GE Healthcare Finland Oy

Kuortaneenkatu 2
FIN-00510 Helsinki, Finland
Manufacturer's quality system ISO9001
according to
Manufacturer's environmental ISO14001
management system according
to
General Medical electrical equipment
Model MGF 110
Power supply Mains plug connection, 1-phase
(line, neutral and protective

FOR TRAINING PURPOSES ONLY!

ground, or L1, L2 and protective
ground)
Apparent resistance of supply 0.75Ω
mains
Rated voltage 230 Vac ±10%, single phase, 50/
60 Hz (USA)
20 A (16 A) line

NOTE!
The Performa is a cord-connected device, delivered without a plug (in
some markets). Depending upon local electrical code requirements, it
may be either hard-wired or plugged into an outlet. Please consult your
electrician to determine the requirements, and if necessary to provide a
plug which matches your outlet.

Line Regulation: ± 2% (full load)

Branch Circuit: dedicated run 20A, 2-pole circuit
breaker L1/L2 (10 AWG)
Outlet per local electrical code
requirements or NEMA L6-20
Grounding: 0V potential (earth), continuous
wire run (not conduit)
Rated current 20 A Momentary (during exposure)
300 mA long term (otherwise)
Rated power 3.6 kVA (2.5kW)
IEC safety class I

37094-IMG rev 3 GE Healthcare 47

6 Specifications

System specifications model MGF-110

IEC applied part type B

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Enclosure IP 20
Weight 265 kg (584 lbs.)
Height 1.9 m (6.23 ft)
Operation mode Continuous operation with
intermittent loading
Radiation intensity Typical range 1000-1200mR/
100mA at 28kV

Environmental specifications

Operating conditions +10°C...+40°C

Non condensing (maximum
humidity 90%)
Storage and transportation (+0°C...+35°C)

FOR TRAINING PURPOSES ONLY!

Humidity 10%...100%
Pressure 500mbar - 1060 mbar

Generator (THF)

Manufacturer GE Healthcare Finland Oy

Type MGHV-200
Frequency 40 - 100 kHz
Power Max. 2.5 kW
kV range 20 - 35 kV, tolerance ±1.5 kV +
instrument inaccuracy
mA range Focus 0.3mm 70 - 100 mA
Focus 0.1mm 20 - 30 mA
Maximum mA output Focus 0.3mm 150mA
Focus 0.1mm 45mA
mAs range Focus 0.3mm 2 - 500 mAs
(600 max in U.K.):
Tolerance:
mAs ≤ 40: ± 4 mAs
mAs > 40: ± 10%
Focus 0.1mm 4 - 300 mAs
Tolerance:
mAs ≤ 40: ± 4 mAs
mAs > 40: ±10%

48 GE Healthcare 37094-IMG rev 3

 6 Specifications

Generator (THF)

Time range Focus 0.3mm 0.05 - 5 s

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(6s U.K.)
Focus 0.1mm 0.05 - 10 s
Tolerance: ± 0.10 + instrument
inaccuracy

Automatic Exposure Control (AEC)

Solid state 15 step density selector

Operating range for large focus 23 - 35 kV for small
focus 25 - 35 kV
Nominal shortest irradiation time 50 msec.

Performa Filtration

Molybdenum 0.03 mm

FOR TRAINING PURPOSES ONLY!

Rhodium 0.025 mm

Positioning

Tube lock Electromagnetic

Movement:
rotation +135( to -180°)
vertical 1200 mm (48”)
SID 600 mm (23 5/8”)

Compression

motorized and manual

Foot pedal protection IPX1
classification

37094-IMG rev 3 GE Healthcare 49

6 Specifications

Recording systems

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Contact for 18 x 24 and 24 x 30cm film
Bucky for 18 x 24 and 24 x 30cm film
Magnification for 18 x 24cm film 1.6, 1.8 & 2.0
exposed size 10 x 24
Biopsy for 18 x 24cm film

Correspondence between X-ray field and image reception area

Chest wall 0...+3 mm

Other walls +1...+5 mm
Correspondence between ≤ 5 mm any wall
collimator light field and X-ray
field

FOR TRAINING PURPOSES ONLY!

Radiation field

Maximum radiation field 24x30cm

Attenuation equivalent

Bucky, cassette tunnel or 0.25 mm Al (Total of all layers)

magnification tunnel

Standard anti-scatter grid

Line pairs 31 or 36 l/cm (see Bucky label)

Grid ratio 5:1

ROC Grid

Line pairs 36 l/cm

Grid ratio equal to 6:1

50 GE Healthcare 37094-IMG rev 3

 6 Specifications

X-RAY TUBE Varian M113SP in B112 housing

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Anode type Rotating dual-angle anode
Anode heat capacity 300,000 HU
Target material Molybdenum alloy, niobium
doped
Anode rotation speed 3000rpm(50Hz)/3600rpm(60Hz)
Focal spot sizes M113SP 0.1, 0.3 (IEC60336)
Port material beryllium
Reference axis 42 mm (M113SP) from chest wall
edge (tube angle 4°)

1 1 Focal spot is marked in the front part of the tube head assembly.
2 The collimator label is at the front end of the tube head assembly.

2
Measurement criteria for exposure time

FOR TRAINING PURPOSES ONLY!

The nominal x-ray voltage 35 kV is obtained at highest tube current 70
mA.
The nominal tube current 70 mA is obtained at the highest tube
voltage 35 kV.
The highest tube current 100 mA is obtained at 25 kV tube voltage.
The highest electric power is obtained at 32 kV tube voltage and 80
mA tube current.
The nominal electric power of 2.4 kW is obtained, when loading time is
0.1s, tube current at 80 mA and x-ray tube voltage at 30 kV.

Fuses

Location Rating Purpose

External: Automatic 15 A/250 V Fuse to the 220 line

fuse or F1, F2 15 ASB/ 250 V Fuses to the 220 line

Supply Board

F1 4 AT/250 V 24 VAC prior to the

regulation, for AMD,
C, Z and the break
F2 5 AT/250 V 18 VAC prior to
regulation for the CPU
and lamp

37094-IMG rev 3 GE Healthcare 51

6 Specifications

F3 0.5 AT/250 V 15 VAC prior to

regulation for the
Amplifier Board

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Filament Board

F1 6 AT/250 V 24 VAC to regulators

F2 6 AT/250 V 24 VAC to regulators

Inverter Board

F1 20AF/500V DC-input to Inverter

Board
DC-input to Power
Board

Anode Motor Driver

F1 10 ASB/250 V 220 VAC to rotor

6.2 USER’S STATEMENT OF MODEL MGF 110

Radiation Leakage Technique Factors:

FOR TRAINING PURPOSES ONLY!

The maximum-rated peak tube potential is 39 kVp and the maximum
rated continuous tube current is 4.0 mA (Duty cycle 1:12) for the maximum
rated peak tube potential at large focal spot. The maximum-rated peak
tube potential is 35 kVp and the maximum rated continuous tube current
is 4.5 mA (Duty cycle 1:3) for the maximum rated peak tube potential at
small focal spot.

Beam limiting device/Tube Housing assembly Compatibility:

The tube housing assembly is compatible with the interchangeable plate

collimator assembly which is an integral part of the tube head and can
only be used with the tube housing assembly.

Equipment Statement for Tube Housing Assembly:

Maximum operating voltage: 35 kVp effective focal spot 0.3 mm for large
spot 0.1 mm for small focal spot.

X-ray tube: Varian M113SP 0.3/0.1. For additional information refer to tube
specification sheets.

6.2.1 Operating Parameters

Maximum Deviation of Peak Tube Potential from Indicated Value:

±1.5 kV + instrumentation inaccuracies (1.5% of the reading + 600 V) as

measured by a calibrated Dynalyzer

Maximum Deviation of Tube Current-Exposure time from Indicated

Value:

±4 mAs for mAs values less than or equal to 40 mAs, ±10% for mAs values
greater than 40 mAs.

52 GE Healthcare 37094-IMG rev 3

 6 Specifications

Maximum Deviation of Timer from Indicated Value:

±0.1 second + instrumentation inaccuracies (0.5% of the reading + 0.25

msec.) as measured by a calibrated Dynalyzer.

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Power Supply Requirements:

Line voltage 230 VAC ±10%, 50/60 Hz, single phase. Operating Voltage
Range 198-242 (±10%) Automatic regulation for all voltages within
Operating Voltage Range.

Maximum Line Current:

Maximum line current during exposure is 20 A at technique factors 25 kVp

and 100 mA. The system line circuit breaker is 15 A because the maximum
line current of 20 A is only during short peaks during the exposure.

General Output Rating and Duty Cycle:

At 230 VAC nominal:

Large Focal Spot 100 mA at 25 kV

70 mA at 35 kV (55mA sw 7.8x)
Small Focal Spot 30 mA at 23 kV
20 mA at 35 kV

FOR TRAINING PURPOSES ONLY!

Exposures are automatically limited if the tube or housing heat capacity
counter is activated.

Tube protection counter:

Anode:
Heating = kV x mAs = Joule (increased only during exposures)
Cooling = 30 Joule / sec (decreased continuously)

Housing:
Heating = kV x mAs = Joule (increased only during exposures)
Cooling = refer to diag. below (decreased continuously)

Fig 6.1. Housing cooling characteristics

37094-IMG rev 3 GE Healthcare 53

6 Specifications

6.3 TUBE LOADING CHART FOR THE M113SP TUBE

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
kV M113SP mA M113SP
(SF) (sw 7.7x) mA
(LF)

20 25 75
21 26 80
22 28 85
23 30 90
24 29 95
25 28 100
26 27 95
27 26 90
28 25 85
29 24 85

FOR TRAINING PURPOSES ONLY!

30 23 80
31 22 80
32 21 80
33 21 75
34 20 75
35 20 69
Table 6.1 Maximum mAs/mA values depending on kV, focus size and country code.
Software version 7.7x.

SF = Small focus, LF = large focus

Time range with loading factors shown above:

Focus 0.3 0.05 - 5.0 sec. (6.0 sec. in UK)

Focus 0.1 0.05 - 10.0 sec.

54 GE Healthcare 37094-IMG rev 3

 6 Specifications

6.4 ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
The Performa is suitable for use in the specified electromagnetic environment. The purchaser or user
of the Performa should assure that it is used in an electromagnetic environment as described below:

Emissions Test Compliance Electromagnetic Environment

Radio-Frequency Group 1 The Performa uses RF energy only for its internal function.
Emissions Therefore, the RF emission is very low and not likely to cause
CISPR11 any interference in nearby electronic equipment.
Radio-Frequency Class B The Performa is suitable for use in all establishments,
Emissions including domestic establishments and those directly
CISPR11 connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions Not The Performa is suitable for use in all establishments,
applicable including domestic establishments and those directly
IEC 61000-3-2 connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Voltage Not The Performa is suitable for use in all establishments,
fluctuations/ applicable including domestic establishments and those directly
flicker emissions connected to the public low-voltage power supply network

FOR TRAINING PURPOSES ONLY!

that supplies buildings used for domestic purposes.
IEC 61000-3-3
Table 6.2 Electromagnetic emissions IEC 60601-1-2

37094-IMG rev 3 GE Healthcare 55

6 Specifications

The Performa is suitable for use in the specified electromagnetic environment. The purchaser or user
of the Performa should assure that it is used in an electromagnetic environment as described below:

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Immunity Test IEC 60601-1-2 Compliance Electromagnetic Environment
Test Level Level

Electrostatic ± 2, 4, 6 kV for ± 2, 4, 6 kV for Floors are wood, concrete, or ceramic

discharge (ESD) contact discharge contact discharge tile, or floors are covered with
IEC 61000-4-2 ± 2, 4, 8 kV for air ± 2, 4, 8 kV for air synthetic material and the relative
discharge discharge humidity is at least 30 percent.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality is that of a
transient/burst supply lines supply lines typical commercial and/or hospital
IEC 61000-4-4 environment
± 1 kV for ± 1 kV for
input/output input/output
lines lines
Surge ± 1 kV differential ± 1 kV differential Mains power quality is that of a
IEC 61000-4-5 mode mode typical commercial and/or hospital
± 2 kV common ± 2 kV common environment.
mode mode

FOR TRAINING PURPOSES ONLY!

Voltage dips, 0 % Un for 5 sec 0 % Un for 5 sec Mains power quality is that of a
short typical commercial and/or hospital
interruptions and environment. If the user of the
voltage Performa requires continued
variations on operation during power mains
power supply interruptions, it is recommended that
input lines the Performa be powered from an
IEC 61000-4-11 uninterruptible power supply or a
battery.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields are
(50/60 Hz) at levels characteristic of a typical
magnetic field location in a typical commercial and/
IEC 61000-4-8 or hospital environment.
NOTE: Un is the a.c. mains voltage prior to application of the test level.
Table 6.3 Electromagnetic immunity IEC 60601-1-2

56 GE Healthcare 37094-IMG rev 3

 6 Specifications

The Performa is suitable for use in the specified electromagnetic environment. The purchaser or user
of the Performa should assure that it is used in an electromagnetic environment as described below:

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Immunity IEC Compliance Electromagnetic
Test 60601-1-2 Level Environment
Test Level

Portable and mobile RF communications equipment

are used no closer to any part of the Performa,
including cables, than the recommended separation
distance calculated from the equation appropriate for
the frequency of the transmitter.

Recommended Separation Distance:

Conducted 3 V150 kHz [ V1 ] 3 V 3,5
RF IEC to80 MHz d =[ ] P
61000-4-6 V1

Radiated 3 V/m80 MHz [ E1 ] 3 V/m 3,5

RFIEC to2,5 GHz d =[ ] P
E1 80 MHz to 800 MHz
61000-4-3

FOR TRAINING PURPOSES ONLY!

7
d =[ ] P
E1 800 MHz to 2,5 GHz

Where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).Field strengths from fixed RF
transmitters, as determined by an electromagnetic site
survey,* are less than the compliance level in each
frequency range.** Interference may occur in the
vicinity of equipment marked with the following
symbol:

*Field strengths from fixed transmitters, such as base stations for cellular telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be performed. If the measured field strength exceeds the RF compliance level above,
observe the Performa to verify normal operation in each use location. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Performa.
**Over the frequency range 150 kHz to 80 MHz, field strengths are less than [V1] V/m.
The Recommended Separation Distances are listed in the next table.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
Table 6.4 RF immunity of non-life-support equipment or system IEC 60601-1-2

37094-IMG rev 3 GE Healthcare 57

6 Specifications

Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC
60601-1-2

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
Frequency of 150KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Transmitter

3,5 3,5 7
Equation d =[ ] P d =[ ] P d =[ ] P
V1 E1 E1

Rated Maximum Separation Distance Separation Distance Separation Distance

Output Power of (meters) (meters) (meters)
Transmitter (watts)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.69 3.69 7.38
100 11.67 11.67 23.34

FOR TRAINING PURPOSES ONLY!

Table 6.5 Recommended Separation Distances for Portable and Mobile RF Communications Equipment IEC 60601-1-2

58 GE Healthcare 37094-IMG rev 3

 7 M113SP X-ray tube data sheets

7 M113SP X-ray tube data sheets

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7.1 M113SP TUBE DATA SHEET
Various tube charts and markings are included in the latest revision of
5708, M113SP Rotating Anode Tube by Varian Medical Systems.

7.2 M113SP FILAMENT EMISSION CHARTS

3 Ø Full Wave

FOR TRAINING PURPOSES ONLY!

37094-IMG rev 3 GE Healthcare 59

60
7.4
7.3
7 M113SP X-ray tube data sheets

GE Healthcare
ANODE HEATING AND COOLING CURVES

HOUSING HEATING AND COOLING CURVES

37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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37094-IMG rev 3
7.5
7.5.1

GE Healthcare
SINGLE LOAD RATINGS
3 Ø Constant Potential 50 Hz

61
7 M113SP X-ray tube data sheets

FOR TRAINING PURPOSES ONLY!

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62
7.5.2
7 M113SP X-ray tube data sheets

3 Ø Constant Potential 60 Hz

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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 7 M113SP X-ray tube data sheets

7.6 DESCRIPTION
The M113SP rotating anode X-ray tube is a 39 kVp VARIAN insert tube with

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
0.1 mm and 0.3 mm focal spot combination and 77 mm diameter bi-
angular (10°/16°) Molybdenum anode disc, cathode grounded.

The M113SP metal center section X-ray tube is for use in Mammography
systems. The use of a metal center section tube eliminates arcing due to
metal deposition on glass and allows use of a Beryllium window in the
insert for minimum inherent filtration.

7.7 GENERAL DATA

Maximum Peak Voltage: 39 kV (Anode to Ground)

Nominal Focal Spot Size: Small: 0.1 mm (Refer to General
Information Section for Focal Spot
Measurement Method)

Large: 0.3 mm
Maximum Anode Load: 3-phase, 180Hz, 0.1 second
Small Focal Spot: 1320 W
Large Focal Spot: 4.9 kW

FOR TRAINING PURPOSES ONLY!

Anode Disc Construction: Molybdenum Alloy
Anode Disc Diameter: 77 mm
Anode Disc Target Angle: M113SP (LF/SF) 16/10
Anode Heat Storage: 300 kHU
Maximum Anode Cooling Rate: 60,000 HU/minute
Inherent Filtration: 0.0 mm Alum. Equiv. 0.76 mm
Beryllium
U/L Approved: Yes

7.8 B-112 HOUSING

Class: I
Type: B
Maximum Peak Voltage: 52 kV
Anode to Ground: 52 kV
Cathode to Ground: 0 kV
Housing Heat Storage Capacity: 370 KJ (500 kHU)
Housing Cooling Rate: 100 Watts (135HU/sec)
Weight: 10.2 kg (22.5 lbs)
Length: 33 cm (13”)
Diameter: 13.8 cm (5.44”)
Focal Spot - Port Spacing: Small 47.0mm +/- 1mm
Large 41.4 +/- 1mm
High Voltage Cable, Special Design 55 kV Rating
(Non-Federal Standard):
Acoustic noise: 50dB Max. (A-weighted) at 30 cm
Leakage Technique Factor M113SP: 52 kV, 2mA

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7 M113SP X-ray tube data sheets

Leakage Technique Factor B112: 55 kV, 4mA

Minimum Ambient temperature for -9°C (16°F)
storage & transportation:

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Maximum Operation Temperature: +40°C (+104°F)
Low Voltage Cable:
Pin Position Function
1 Phase Shift
2 Phase
3 Common
4 Housing Ground
5 Grid
6 Not used
7 Small Filament
8 Filament Common
9 Large Filament

7.9 FILAMENTS

Focal spot Volts Amperes

FOR TRAINING PURPOSES ONLY!

0.1 3.8 - 7.3 3.0 - 4.8
0.3 6.0 - 10.5 3.6 - 5.2

7.10 STATOR 50/60 HZ

Starting 115 V 230 V

Amperes 4 8
Seconds to 1 0.5
start
Duty Intermittent Intermittent

Running 45 V 90 V

Amperes 1.4 - 2.0 1.4 - 2.0

Duty Continuous Continuous

PHASE SHIFT CAPACITOR: 30 Microfarad

Safety: Thermal Switch

– Connected in series with stator common wire

– Opens at 79.4°C ± 3.9°C (175°F ± 7°F)
– Closes at 68.3°C ± 3.9°C (155°F ± 7°F)

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 7 M113SP X-ray tube data sheets

7.11 INHERENT FILTRATION

Inherent filtration of the insert is 0 mm Aluminum equivalent. For

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
operation of the X-ray tube to 39 kV, a minimum of 0.5mm Aluminum
equivalent must be added to the X-ray beam.

Leakage Technique Factor M113SP: 40 pkV, 7mA

Minimum Ambient temperature for storage & -10°C (15°F) to +75°C
transportation: (+167°F)
Operation Temperature: +5°C (+41°F) to +40°C
(+104°F)

7.12 RAYPROOFING
Stray radiation complies with the requirements of FDA 21 CFR, Subchapter
J for medical diagnostic-type protective X-ray tube housings.

7.13 FOCAL SPOT MEASUREMENT METHOD

M113SP small focus:

FOR TRAINING PURPOSES ONLY!

Measured at 25kV, 20mA with one degree star pattern or a slit focal.
Maximum focal spot size = 0.15W x 0.15L (mm).

M113SP large focus:

Measured at 25kV, 80mA with one degree star pattern or a slit focal.
Maximum focal spot size = 0.45W x 0.58L (mm).

Specification of the maximum focal spot size limits must be performed at

the techniques listed above.

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66
7 M113SP X-ray tube data sheets

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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 8 System maintenance

8 System maintenance

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8.1 CLEANING

WARNING!
Before cleaning and disinfecting, remove power from the equipment.

ALL parts of the unit which come in contact with the patient must be
cleaned and disinfected prior to each examination.

The standard hospital regimen for disinfection should be followed, with

the following qualifications:

DO NOT clean surfaces on parts which contact the patient (i.e., face shield,
cassette holders, Bucky devices, compression paddles) with solvent-
based cleaners (containing benzene, alcohol, or stain removers).

DO NOT use extra-strength or abrasive cleaners, polishes, or waxes on

parts which contact the patient.

FOR TRAINING PURPOSES ONLY!

Proprietary disinfectant solutions meeting the above limitations are
suitable, provided that the manufacturer’s instructions are stringently
followed. DO NOT immerse the Bucky in disinfectant solution.

As a general rule, disinfectant sprays may not be used directly. The mist
generated by spraying may penetrate into the unit, and this may damage
electronic components. To use a disinfectant agent in spray form, first
apply the agent to a clean cloth or pad, and then use the pad to apply the
agent to the surface requiring disinfectant.

For general cleaning, use a non-lint cloth dampened with water, or a

lukewarm, diluted aqueous solution of household dishwashing liquid.

8.2 CARE
Handle the plastic accessories carefully, and inspect them frequently. If
they begin to crack, discontinue their use and replace them.

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8 System maintenance

8.3 OPERATORS MAINTENANCE SCHEDULE

The following inspections must be performed monthly by the operator of

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the equipment.

1 Visual Exposure Indicator

Confirm that the exposure indicator light stays on for the length of
the exposure.
2 Audible Exposure Indicator
Confirm that the buzzer stays on for the length of the exposure.
3 Exposure Switch
Confirm that the exposure switch requires continuous pressing to
maintain the exposure and that releasing of the switch terminates
the exposure and that the timer display indicates “Rel”.
4 Warning and Indicator Labels
Inspect and confirm that all warning labels and embossed, painted
or other wearable labels have not been defaced or worn and that
they are legible.
5 Automatic Exposure Control (AEC)
Confirm that the autoexp light illuminates when AEC is selected.
6 Vertical Movement
Check that the carriage moves smoothly and in both directions.

FOR TRAINING PURPOSES ONLY!

7 Compression force
Check that the compression force has not changed.
8 Compression release when power failure
Check that the compression paddle drives up about 5 seconds when
the mains voltage is disconnected
9 Rotation Movement and angle display
Check that the C-Arm moves smoothly in all positions. Check that the
displayed angle corresponds to the selected angle.
10 Control Panel
Check that all buttons in the control panel are intact by noticing that
all lights and display segments are lit up after connecting the main
power on and pressing the reset (AUTOEXP) button.
11 Compression thickness display check
Place 60 mm acrylic on the cassette holder. Drive down the
compression paddle against the acrylics. Check that thickness
display indicates 6.0 cm. If not, call for service.
12 Manual decompression
Compress against an object at 200N and verify that you can
decompress manually with hand wheels.
13 Emergency buttons
Verify that all electronically controled movements (vertical, c-arm
rotation, compression) are disabled when emergency button is
pressed down. All motorized movements should stop. Release the
emergency stop button, switch on the unit once again and then
repeat the test using the emergency stop button on the opposite side
of the unit. Finally, verify that normal operation of the unit is restored
once the button is back in normal position.

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 8 System maintenance

8.4 PREVENTIVE MAINTENANCE SCHEDULE

The following inspections must be scheduled by the user. Only authorized

NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
and trained service technicians are allowed to carry out the maintenance
on this equipment. Manufacturer can supply at request necessary
documents to Instrumentarium Imaging approved service technician for
repair of such parts that the manufacturer has indicated to be repairable.

Once a year Section in installation instructions

1 kV/mAs/preheat tests. Perform tests 4.10, 4.11 and 5.2.9.
2 X-ray and light fields. Perform tests 5.2.11 and 5.2.12.
3 AEC adjustment. AEC adjustment. Perform test 5.2.14.
4 Safety ground. Verify that the metal parts of the
unit are connected to protective
ground.
5 Oil leaks. Check that the high voltage unit and
the tube housing do not leak oil.
6 Anode run voltage. Perform test 4.9.
7 Compression force. Perform test 5.2.5 and 5.2.7.
8 C-Arm rotate brake. Perform test 5.2.3.
9 Interlock system. Check that exposures are not
allowed if the diaphragm, cassette

FOR TRAINING PURPOSES ONLY!

holder or the cassette is missing.
Check the error codes.
10 Clean High Voltage Connections and grease with clean grease for
example DowCorning #4.
11 Lubricate the counterweight wires with a light coat of “STP” or “CRC”.
Do not apply degreasers or cleaners. Replace if broken strands are
found.
12 Tighten ground connections. Inspect crimps, connections and cables
for wear or breakage.

37094-IMG rev 3 GE Healthcare 69

8 System maintenance

8.5 QUALITY ASSURANCE

If the performance of the unit has changed, please contact your local

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distributor.

Distributor:
Contact person: Tel:
PERFORMA serial Installation
number *): date:
Last
maintenance
performed:
Exposure counter
number:
Last
maintenance
performed:
Exposure counter
number:

FOR TRAINING PURPOSES ONLY!

*) The serial number is printed on a label attached to the rear cover of the
unit.

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 8 System maintenance

TEST FREQUENCY TOOL(S) PERFORMED BY

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Film Processor Daily Thermometer Radiographer/
Densitometer Technologist
Sensitometer
Image Quality Weekly RMI 156D Radiographer/
Phantom Technologist
Physician
Phototimer Monthly Acrylic Radiographer/
Reproducibility phantom Technologist
Physician
Film/Screen Semi-annually Contact test Physicist or
Contact tool Service
Technician
kVp Semi-annually Dynalyzer Physicist
Dose/Patient Semi-annually Ion Chamber Physicist
Exposure
Half-Value Semi-annually Aluminum HVL Physicist

FOR TRAINING PURPOSES ONLY!

Layer (HVL) set with Ion
Chamber
mAs (mA) Semi-annually Dynalyzer (mAs Physicist or
meter) Service
Technician
mAs Linearity Semi-annually Ion Chamber Physicist or
(Digital) Service
Technician
Compression Semi-annually Scale Radiographer/
Technologist
Exposure Annually Ion Chamber Physicist or
Reproducibility Service
(mR/mAs) Technician
Line pair Annually Bar Pattern Physicist
resolution

NOTE!
Refer to local regulations and instructions concerning the testing of the
unit.

If the unit does not meet the manufacturer´s specifications, despite of

proper maintenance and repair, the operating life of the unit has come to
an end. As the used X-ray tube and oil, high voltage unit, all electronic
boards and parts of lead in collimator and under the AEC detectors are
toxic waste, refer to country-specific disposal instructions.

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72
8 System maintenance

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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 9 Graphical symbols used

9 Graphical symbols used

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Radiographic control

Earth (ground)

Protective earth (ground)

Type B equipment

Dangerous voltage

ON (Power)

OFF (Power)

Attention, consult accompanying documents

FOR TRAINING PURPOSES ONLY!

Vertical movement up and down (Movement in both
directions)

Brake release (Rotation in two directions)

Compression paddle up/down (Movement in one

direction)

Beam field illumination

Compression force (Variability)

The unit is CE-marked according to the Medical Device

Directive 93/42/EEC (if the unit contains CE mark).

Unit (if the unit contains UL/CSA mark) is tested and

certified according to UL/CSA (file E218408).

This symbol (if marked) indicates that waste electrical

and electronic equipment must not be disposed of as
unsorted municipal waste and must be collected
separately. Please contact an authorized
representative of the manufacturer for information
concerning the decommissioning of your equipment

37094-IMG rev 3 GE Healthcare 73

74
9 Graphical symbols used

GE Healthcare
37094-IMG rev 3
FOR TRAINING PURPOSES ONLY!
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 FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
 NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
FOR TRAINING PURPOSES ONLY!
General Electric Company reserves the right to make changes in specification and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your GE
representative for the most current information.

Copyright © 2000 by General Electric Company Inc. All rights reserved.

GE Healthcare Finland Oy, a General Electric company, going to market as GE Healthcare.

World Headquarters
GE Healthcare
P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

European Headquarters
GE Healthcare - Europe:
Paris, France - Fax +33-1-30-70-94-35

Asia Pacific
GE Healthcare -Asia:
Tokyo, Japan - Fax +81-425-85-5490
Hong Kong - Fax: +852-2559-3588

www.gehealthcare.com

Performa

Operation Instructions, English

37094-IMG rev 3 Printed in Finland 10/2006