Professional Documents
Culture Documents
GENESIS DT/DTs
BH-EN-SW 1071
Release: 16.08.2016
List of contents
List of contents .............................................................................................................................................. I
List of tables ............................................................................................................................................. IV
List of figures ............................................................................................................................................. VI
1 Safety guidelines and style ..................................................................................................... 1
1.1 Symbols used ......................................................................................................................... 1
1.2 Copyright ............................................................................................................................... 2
2 Safety ..................................................................................................................................... 3
2.1 General guidelines /purpose of use ........................................................................................ 3
2.1.1 Installation and service, maintenance, safety-related check ................................................... 3
2.1.2 Cleaning and disinfection....................................................................................................... 3
2.1.3 Electrical safety ...................................................................................................................... 3
2.1.3.1 Protection against electric shock ............................................................................................ 3
2.1.3.2 Earthing instructions .............................................................................................................. 4
2.1.4 Operating safety ..................................................................................................................... 4
2.1.5 Systems .................................................................................................................................. 4
2.1.6 Scope of responsibility ........................................................................................................... 4
2.1.7 Improper operation................................................................................................................. 5
2.1.8 Explosion protection .............................................................................................................. 5
2.1.9 Maintenance ........................................................................................................................... 5
2.1.10 Legally required inspections .................................................................................................. 5
2.1.11 Disengaging from operation................................................................................................... 5
2.1.12 Disposal of used equipment/ 2002/96/EC (WEEE) Directive ............................................... 5
2.2 Radiation protection ............................................................................................................... 6
2.2.1 Personnel safety ..................................................................................................................... 6
2.2.2 Safety with Automatic Exposure Control (AEC) ................................................................... 6
2.3 Electromagnetic safety ........................................................................................................... 7
2.3.1 GENESIS DT ......................................................................................................................... 7
2.3.2 GENESIS DTs ..................................................................................................................... 11
3 Technical specifications ....................................................................................................... 15
3.1 Dimensions and weights ...................................................................................................... 15
3.1.1 Dimensions .......................................................................................................................... 15
3.1.1.1 GENESIS DT ....................................................................................................................... 15
3.1.1.2 GENESIS DTs ..................................................................................................................... 15
3.1.1.3 GENESIS DT/DTs user console .......................................................................................... 16
3.1.2 Weights ................................................................................................................................ 16
3.1.3 Nameplate ............................................................................................................................ 16
3.1.3.1 GENESIS DT ....................................................................................................................... 16
3.1.3.2 GENESIS DTs ..................................................................................................................... 17
3.1.4 Where is the nameplate? ...................................................................................................... 17
3.2 Electrical data ...................................................................................................................... 18
3.2.1 GENESIS DT ....................................................................................................................... 18
3.2.2 GENESIS DTs ..................................................................................................................... 19
3.3 Environmental conditions .................................................................................................... 19
3.4 Recommended lengths of cables connecting peripheral equipment ..................................... 19
3.5 Compatibility ....................................................................................................................... 20
3.5.1 Essential performance requirements .................................................................................... 20
3.5.2 Sample system ..................................................................................................................... 21
3.6 Original language ................................................................................................................. 21
3.7 Fuses .................................................................................................................................... 21
3.8 Power supply for control panel ............................................................................................ 22
3.9 Manufacturer/Installer .......................................................................................................... 23
4 Operation of the GENESIS DT/DTs .................................................................................... 24
List of tables
Table 2-1: Electromagnetic emissions ..................................................................................................... 7
Table 2-2: Electromagnetic interference resistance ................................................................................. 8
Table 2-3: Electromagnetic interference resistance ................................................................................. 9
Table 2-4: Recommended separation distances between portable and mobile HF communications
equipment and medical devices ........................................................................................... 10
Table 2-5: Electromagnetic emissions ................................................................................................... 11
Table 2-6: Electromagnetic interference resistance ............................................................................... 12
Table 2-7: Electromagnetic interference resistance ............................................................................... 13
Table 2-8: Recommended separation distances between portable and mobile HF communications
equipment and medical devices ........................................................................................... 14
Table 3-1: Weights ................................................................................................................................ 16
Table 3-2: GENESIS DT electrical specifications ................................................................................ 18
Table 3-3: GENESIS DTs electrical specifications ............................................................................... 19
Table 3-4: Environmental conditions .................................................................................................... 19
Table 3-5: Recommended lengths of cables connecting peripheral equipment ..................................... 20
Table 3-6: Compatibility table............................................................................................................... 21
Table 3-7: Specified miniature fuses ..................................................................................................... 22
Table 3-8: Power supply for the control panel ...................................................................................... 22
Table 4-1: Control panel controls .......................................................................................................... 26
Table 4-2: Display of load limits during exposure ................................................................................ 26
Table 4-3: Display of load limits of X-ray tube assembly during fluoroscopy ..................................... 26
Table 4-4: Available exposure techniques ............................................................................................. 28
Table 4-5: Possible diagnostic devices .................................................................................................. 29
Table 4-6: Possible focal spots (focuses) .............................................................................................. 29
Table 4-7: Selection of measuring fields, exposure control turned on or off ........................................ 30
Table 4-8: Adjustment of tube voltage .................................................................................................. 30
Table 4-9: Tube voltage in exposure points .......................................................................................... 31
Table 4-10: Adjustment of the tube current ............................................................................................. 31
Table 4-11: Tube current in the R10 series ............................................................................................. 31
Table 4-12: Adjustment of the current-time product ............................................................................... 32
Table 4-13: Current-time product in exposure points .............................................................................. 32
Table 4-14: Adjustment of the current-time product ............................................................................... 32
Table 4-15: Current-time product in exposure points .............................................................................. 33
Table 4-16: Charge status of Supercap energy memory .......................................................................... 33
Table 4-17: Display of tube position detector (TPD) .............................................................................. 33
Table 4-18: Process of the exposure release ............................................................................................ 34
Table 4-19: Selection of adults or children ............................................................................................. 35
Table 4-20: Body regions of the anatomic selector (13) ......................................................................... 36
Table 4-21: List / description of the exposure parameters....................................................................... 38
Table 4-22: Setting film/foil combination ............................................................................................... 38
Table 4-23: Setting blackness .................................................................................................................. 39
Table 4-24: Patient’s stature adjustment ................................................................................................. 39
Table 4-25: Examination device for fluoroscopy .................................................................................... 40
Table 4-26: Brief description of the fluoroscopy controls ....................................................................... 41
Table 4-27: Fluoroscopy control function ............................................................................................... 41
Table 4-28: Selecting fluoroscopy mode ................................................................................................. 42
Table 4-29: Adjustment of tube voltage for fluoroscopy ........................................................................ 42
Table 4-30: Adjustment of the tube current in fluoroscopy..................................................................... 43
Table 4-31: Selection options for high-current fluoroscopy.................................................................... 43
Table 4-32: On and off switch for the automatic dose rate control ......................................................... 44
Table 4-33: Reset and stop button for fluoroscopy timer ........................................................................ 45
Table 5-1: Fine parameter grading ........................................................................................................ 49
Table 5-2: Exposure points - tube voltage ............................................................................................. 49
Table 5-3: Exposure points - current-time product................................................................................ 50
List of figures
Figure 3-1: GENESIS DT/DTs dimensional drawing ............................................................................ 16
Figure 3-2: sample GENESIS 50 DTF nameplate .................................................................................. 16
Figure 3-3: sample GENESIS 50 DTs nameplate ................................................................................... 17
Figure 3-4: Layout of the nameplate ....................................................................................................... 17
Figure 4-1: Control panel main switch ................................................................................................... 24
Figure 4-2: Control panel start screen ..................................................................................................... 25
Figure 4-3: Text field (11) - turning off the anatomic program .............................................................. 27
Figure 4-4: Fluoroscopy operating mode is turned on ............................................................................ 28
Figure 4-7: Selection of diagnostic devices ............................................................................................ 28
Figure 4-8: Selection of focal spot size................................................................................................... 29
Figure 4-9: Turning on and off automatic exposure control, selecting measuring fields ........................ 30
Figure 4-10: Adjustment and display of tube voltage ............................................................................... 30
Figure 4-11: Adjustment and display of the tube current ......................................................................... 31
Figure 4-12: Display and adjustment of the current-time product ............................................................ 31
Figure 4-13: Adjustment and display of the exposure time ...................................................................... 32
Figure 4-14: Measured exposure parameters ............................................................................................ 34
Figure 4-15: Adult or child ....................................................................................................................... 35
Figure 4-16: Intuitive anatomic program selector (13) ............................................................................. 35
Figure 4-17: Text field (11) - turning off the anatomic program .............................................................. 36
Figure 4-18: Text field with anatomic programs ...................................................................................... 36
Figure 4-19: Selected anatomic program with exposure parameters ........................................................ 37
Figure 4-20: Setting film/foil combination ............................................................................................... 38
Figure 4-21: Setting blackness .................................................................................................................. 39
Figure 4-22: Adjustment of patient’s stature ............................................................................................ 39
Figure 4-23: Organ thickness display ....................................................................................................... 40
Figure 4-24: Selecting the fluoroscopy operating mode ........................................................................... 40
Figure 4-25: Fluoroscopy user interface ................................................................................................... 40
Figure 4-26: Control curve for tube current = function (tube voltage) ..................................................... 41
Figure 4-27: Selecting the fluoroscopy mode – continuous fluoroscopy.................................................. 42
Figure 4-28: Selecting the fluoroscopy type - pulsed fluoroscopy ........................................................... 42
Figure 4-29: Voltage adjustment with fluoroscopy .................................................................................. 42
Figure 4-30: Tube current adjustment with fluoroscopy........................................................................... 43
Figure 4-31: Selecting high-current fluoroscopy ...................................................................................... 43
Figure 4-32: Activation of the automatic dose rate control ...................................................................... 44
Figure 4-33: Fluoroscopic timer ............................................................................................................... 44
Figure 4-34: Reset button for fluoroscopy timer ...................................................................................... 44
Figure 4-35: Pulsed fluoroscopy ............................................................................................................... 45
Figure 5-1: Opening the system menu .................................................................................................... 47
Figure 5-2: System menu ........................................................................................................................ 47
Figure 5-3: Selecting the language ......................................................................................................... 48
Figure 5-4: Display of the exposure data ................................................................................................ 48
Figure 5-5: Settings – selection menu ..................................................................................................... 48
Figure 5-6: Parameter grading ................................................................................................................ 49
Figure 5-7: Button confirmation ............................................................................................................. 50
Figure 5-8 Enabling/disabling help texts ............................................................................................... 50
Figure 5-9: Example of a help text ......................................................................................................... 50
Figure 5-10: Display of the status information ......................................................................................... 51
Figure 5-11: Starting Teamviewer Quick Support .................................................................................... 51
Figure 5-12: Confirmation of saving of the exposure parameters ............................................................ 52
Figure 5-13: Save button .......................................................................................................................... 52
ATTENTION
This notation is used when failure to follow instructions and/or guidelines may result in direct
damage of the equipment.
NOTE
This notation is to highlight useful and important feature information.
NOTE/INFORMATION
This symbol is used to draw the user’s attention to an important item.
WARNING/ATTENTION
This symbol is used when there is a risk of injury or death, or damage to the equip-
ment when instructions, guidelines or procedures are ignored or not followed.
This symbol indicates that the device must not be disposed of with household waste
but must be disposed of in an appropriate manner.
1.2 Copyright
Copyright © Josef Betschart AG, xray-swiss.ch, Seewenstrasse 3, CH-6440 Brunnen, Switzer-
land.
With the delivery of the X-ray generator, non-exclusive, non-transferable rights are given for the
use of the software included on the generator or software on media supplied with the generator,
to be used in conjunction with the supplied X-ray generator.
Prior written consent from Josef Betschart AG is required particularly if the software is modified,
installed on another X-ray generator than the one supplied by Josef Betschart AG, or copied -
even if that copy is created only for the purposes of a backup and/or archiving data.
2 Safety
WARNING
Making changes or modifications to the GENESIS DT/DTs X-ray generator is not
permitted!
NOTE
The contact data of the department responsible to the operator of the system (cus-
tomer service,…) are provided in the dossier of the system. If this information is not
available, the operator should ask the manufacturer of the generator to provide the
information needed (see the title page of this manual for the address of the manufac-
turer).
ATTENTION
In order to eliminate the risk of electric shock, this device must be connected to the
power supply only with the protective cable.
WARNING
The high voltage cables may only be disconnected from the X-ray tube or
from the high voltage transformer after ensuring that all main and auxiliary
power circuits are disconnected.
Only CE labelled peripheral equipment shall be used in the patient’s vicinity.
Concurrent contact of the user between the patient and system parts electri-
cally connected with the generator should be avoided.
Failure to comply with the above rules may result in serious personal injury
and/or equipment damage.
WARNING
Changes or modifications to the GENESIS DT/DTs X-ray generator are not permit-
ted!
2.1.5 Systems
Additional equipment that is connected to medical electrical equipment must have the appropri-
ate certificates to comply with the respective IEC or ISO standards (e.g. IEC 60950 for data
processing equipment). Additionally, all configurations must meet the standard requirements for
medical systems (see IEC 60601-1-1 or section 16 of the 3rd edition of IEC 60601-1, respec-
tively). Any person who connects additional equipment to a medical electrical equipment system
is a system configurator and therefore is responsible for ensuring that the entire system com-
plies with the standard requirements. It should be noted that local laws take precedence over
the above mentioned requirements. For further inquiries, please contact your local dealer.
2.1.9 Maintenance
The maintenance of the generator must be performed by qualified personnel who are familiar
with the safety requirements. (Chapter 6 - Scheduled maintenance).
2-point mode: if the preset mAs product is exceeded by more than 20%;
3-point mode: if the preset switching time is exceeded by more than 20%;
in all exposure modes: when "Dose Test" is selected in the setup, the monitoring system halts
the radiation immediately when the set value of the expected cut-off dose
is not reached within the first 50 ms of the exposure.
2.3.1 GENESIS DT
Tables listed in this chapter show the guidance and the correlated manufacturer’s declarations
according to EN 60601-1-2:2007.
The GENESIS DT X-ray generator is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below.
The customer or the user of the GENESIS DT X-ray generator should ensure that it is used in
such an environment.
Voltage dips, short < 5% UT < 5% UT The mains power supply quality
interruptions and volt- (> 95% intrusion of UT) (> 95% intrusion of UT) should be that of a typical com-
age variations on power for 1/2 period for 1/2 period mercial or hospital environment. If
supply input lines 40% UT 40% UT the user of the GENESIS DT re-
IEC 61000-4-11 quires continued OPERATION even
(60% intrusion of UT) (60% intrusion of UT)
in the case of power supply inter-
for 5 periods for 5 periods
ruptions it is recommended to con-
70% UT 70% UT nect the GENESIS DT to an unin-
(30% intrusion of UT) (30% intrusion of UT) terruptible power source or a bat-
for 25 periods for 25 periods tery.
< 5% UT < 5% UT
(> 95% intrusion of UT) (> 95% intrusion of UT)
for 5 s for 5 s
NOTE UT is the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflec-
tion from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and terrestrial
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with
accuracy. To assess the ELECTROMAGNETIC ENVIRONMENT due to fixed HF transmitters, an electromagnetic site sur-
vey should be considered. If the measured field strength in the location in which the GENESIS DT is used exceeds
the applicable RF COMPLIANCE LEVEL above, the GENESIS DT should be observed at every location to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relo-
cating the GENESIS DT.
b
Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V/m.
Table 2-4: Recommended separation distances between portable and mobile HF communications equipment and medical devices
(TABLE 6 acc. to EN 60601-1-2): Recommended separation distances between portable and mobile HF communica-
tions equipment and the X-ray generator GENESIS DT
The GENESIS DT X-ray generator is intended for use in an ELECTROMAGNETIC ENVIRONMENT in which radiated HF distur-
bances are controlled. The customer or the user of the GENESIS DT can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile HF communications equipment (transmitters) and the AED
as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of transmitter
[W] d = 1.2 √P d = 1.2 √P d = 2.3 √P
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
HF emissions Group 1 The GENESIS DTs uses HF energy only for its
CISPR 11:2009 + A1:2010 internal function. Therefore its HF emissions are
very low and are not likely to cause any interfer-
ence in nearby electronic equipment.
The GENESIS DTs X-ray generator is intended for use in the ELECTROMAGNETIC ENVIRONMENT specified below.
The customer or the user of the GENESIS DTs X-ray generator should ensure that it is
used in such an environment.
± 1, ± 2 kV ± 1, ± 2 kV
Neutral to ground voltage Neutral to ground voltage
Voltage dips, short < 5% UT < 5% UT The mains power supply quality
interruptions and volt- (> 95% intrusion of UT) (> 95% intrusion of UT) should be that of a typical com-
age variations on power for 1/2 period for 1/2 period mercial or hospital environment. If
supply input lines (50/60 Hz) (50/60 Hz) the user of the GENESIS DTs
IEC 61000-4-11 < 5% UT < 5% UT requires continued OPERATION
even in the case of power supply
(> 95% intrusion of UT) (> 95% intrusion of UT)
50Hz: 230 V interruptions it is recommended to
for 1 period for 1 period
60Hz: 110 V connect the GENESIS DTs to an
(50/60 Hz) (50/60 Hz)
uninterruptible power source or a
70% UT 70% UT battery.
(30% intrusion of UT) (30% intrusion of UT)
for 25 periods (50 Hz) for 25 periods (50 Hz)
for 30 periods (60 Hz) for 30 periods (60 Hz)
< 5% UT < 5% UT
(> 95% intrusion of UT) (> 95% intrusion of UT)
for 5 s (50/60 Hz) for 5 s (50/60 Hz)
NOTE UT is the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflec-
tion from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and terrestrial
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with
accuracy. To assess the ELECTROMAGNETIC ENVIRONMENT due to fixed HF transmitters, an electromagnetic site sur-
vey should be considered. If the measured field strength in the location in which the GENESIS DTs is used exceeds
the applicable HF COMPLIANCE LEVEL stated above, the GENESIS DTs should be observed at every location to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the GENESIS DTs.
b
Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V/m.
Table 2-8: Recommended separation distances between portable and mobile HF communications equipment and medical devices
Recommended separation distances between portable and mobile HF communications equipment and the
GENESIS DTs X-ray generator
The GENESIS DTs X-ray generator is intended for use in an ELECTROMAGNETIC ENVIRONMENT in which radiated HF distur-
bances are controlled. The customer or the user of the GENESIS DTs can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
GENESIS DTs as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of transmitter
[W] d = 1.2 √P d = 1.2 √P d = 2.3 √P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres can
be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
WARNING
Operation of the GENESIS DTs in the immediate vicinity of other devices or
stacked with other devices should be avoided, because this may cause faults in
operation. However, if it is not possible to avoid use as described above, the
GENESIS DTs and the other devices should be monitored to ensure that they are
operating correctly.
3 Technical specifications
3.1.1 Dimensions
3.1.1.1 GENESIS DT
750 mm
675 350
mm mm
362 mm 62 mm
Figure 3-1: GENESIS DT/DTs dimensional drawing
3.1.2 Weights
Weight
GENESIS DT generator 89 kg
GENESIS DTs generator 119 kg
Highspeed Starter + 3.9 kg
Exposure option + 1.9 kg
3.1.3 Nameplate
Certified components which may be part of the equipment must comply with the medical device
directive MDD 93/42/EEC. In general, these are the X-ray tubes, the collimator, the bucky, the
grids and the measuring chamber. The nameplates of these components vary depending on the
manufacturer and are located in different places on these parts.
3.1.3.1 GENESIS DT
Front of the
housing
Nameplate
3.2.1 GENESIS DT
For tolerances of the X-ray tube load factors (kV, mA, ms, mAs and dose) specified in EN
60601-2-54 please refer to the installation manual
Type and Model GENESIS 30 DT GENESIS 40 DT GENESIS 50 DT GENESIS 65 DT GENESIS 80 DTH
with Fluoroscopy: “F” is added (GENESIS 30 DTF) (GENESIS 40 DTF) (GENESIS 50 DTH) (GENESIS 65 DTH) (GENESIS 80 DTFH)
with HSS: “H” is added (GENESIS 50 DTF) (GENESIS 65 DTF)
(GENESIS 50 (DTFH)) (GENESIS 65 DTFH)
Power 30 kW 40 kW 50 kW 65 kW 80 kW
Inverter
120 kHz
frequency
kV – voltage range 40 ... 125 kV (150 kV as an option)
in steps of 1 kV
Model with
exposure: 40 .... 120 kV
kV – with fluoroscopy 1 kV
in steps of
Model with normal 1 - 5 mA
exposure: high current 5 - 20 mA
mA – with fluoroscopy pulsed 10 - 200 mA
Model with
exposure:
30
Imaging sequence
(max. pulses/sec.)
Peak current (full load) 65 Apeak 85 Apeak 105 Apeak 136 Apeak 168 Apeak
Resistance per phase 0.35 max. 0.27 max. 0.22 max. 0.17 max. 0.14 max.
NOTE
If an X-ray tube assembly with high-speed anode is connected to the generator, and
if the Highspeed Starter is activated, the speed of the rotating anode is automatically
defined by the generator depending on the specified exposure parameters.
Manual selection of the speed of the rotating anode by the operator is not intended
and is therefore not possible.
Power 50 kW
1 ms ... 6.3 s
ms – exposure time
Range 1 ... 100ms / 1ms Step
in steps of
Range 100 ... 500ms / 5ms Step
Range 500 ... 1000ms / 10ms Step
Range 1000 ... 6300ms / 50ms Step
Fuses 3 x 10 Aslow-blow
NOTE
The output of 50 kW remains restricted to the period of 100 ms at a current of 500
mA.
3.5 Compatibility
The GENESIS DT/DTs X-ray generator forms a functioning X-ray system together with the other
components. The generator is designed to meet the Medical Device Directive (MDD 93/42/EEC)
essential requirements for medical equipment, as well as it guarantees the additional essential
performance requirements in accordance with EN 60601-2-54 in combination with all peripheral
components with CE designation that are foreseen to be connecting to the X-ray generator of
this type, and are connected according to the requirements of the manufacturer.
Component: Description:
(1)
X-ray generator GENESIS DT – 50 kW
(2)
GENESIS DTs – 50 kW
(1)+(2)
X-ray tube assembly IAE RTM 782 (0.6 – 1.2) in the C352 housing
(1)+(2)
High voltage cable Claymount 12 metres with FS connector
(1)+(2)
Collimator Ralco R 302/A
(1)+(2)
Automatic exposure control Vacutec BAK 70 151 measuring chamber
(1)
Dose area product Vacutec VacuDAP 2004 DAP measuring chamber
(2)
Vacutec VacuDAP Duo DAP measuring chamber
(1)+(2)
Bucky PROTEC LR 0502
(1)+(2)
Anti-scatter grid SOYEE 40L/cm, FFD 90-120 cm, 12:1, focusing
(1)+(2)
2-stage hand switch Newheek ®LS04 Hand Switch
Table 3-6: Compatibility table
Other CE-compliant components can be connected to the generator (CE Declaration of Con-
formity must be present). The technician in charge or technician is responsible for ensuring that
the generator is matched to the connected components. (Compliance with the essential per-
formance, compliance with international and/or national standards/regulations).
WARNING
The use of different accessories from those specified by the manufacturer as suit-
able may result in increased ELECTROMAGNETIC INTERFERENCE EMISSIONS or reduced
electromagnetic fault resistance of the device and faulty operation.
3.7 Fuses
The GENESIS DT and GENESIS DTs use a variety of fuses. These may be replaced by appro-
priately instructed and trained technical personnel as required:
Nominal Nominal
Fuse System Type
value voltage
FC 1 Charger 10 A 250 V FST 5x20 - Schurter DTs
FC 2 Charger 1A 250 V FST 5x20 - Schurter DTs
F1 prim Input circuit 5A 250 V FST 5x20 - Schurter DT/DTs
F2 sec Input circuit 5A 250 V FST 5x20 - Schurter DT/DTs
5A DT
F3 sec Input circuit 250 V FST 5x20 - Schurter
6.3 A DTs
F4 sec Input circuit 6.3 A 250 V FST 5x20 - Schurter DT
F1.1 Bigboard 1 800 mA 250 V FST 5x20 - Schurter DT/DTs
F1.2 Bigboard 1 800 mA 250 V FST 5x20 - Schurter DT/DTs
F1.3 Bigboard 1 315 mA 250 V FST 5x20 - Schurter DT/DTs
F1.4 Bigboard 1 6.3 A 250 V FST 5x20 - Schurter DT/DTs
*The F3.1 fuse is inside the quick-start unit. The fuse is easily accessible when the generator cover is removed.
WARNING
In order to replace the fuses, the generator cover must be removed. Therefore, there
is a risk of contact with live parts.
WARNING
Burned-out fuses must only be replaced with fuses of the same nominal value. Re-
placing fuses with a larger nominal value can lead to danger to patients and/or staff,
as well as damage to the generator or peripheral components.
NOTE
The power supply for the control panel must have the following specification: “Suit-
able for use in or with IT equipment”.
3.9 Manufacturer/Installer
Josef Betschart AG
xray-swiss.ch
Seewenstrasse 3
CH-6440 Brunnen
Switzerland
Tel.: +41 (0) 41 825 60 80
Fax: +41 (0) 41 825 60 85
Email: info@xray-swiss.ch
If no information on the installer is provided, the user should get in touch directly with the manu-
facturer if need be.
ATTENTION
For reasons of safety it is important not to touch the patient while manipulating the X-
ray system.
Main switch
The main switch (membrane button) is at the bottom of the equipment to the left of the power
plug. Pressing this membrane button will switch the control panel on and off. When the control
panel is completely shut down, power supply to the generator can be disconnected by the main
switch.
GENESIS DTs: Status display of the Supercap memory integrated in the GENESIS DTs.
(Optional) Display/operation of tube position detector for the fail-safe circuitry required in many
countries.
Button to switch between anatomic programs for adults and children
Button to save the changed exposure parameters
Button to select the system menu (language selection, viewing the last exposure data, genera-
tor settings, backing up data)
Table 4-1: Control panel controls
The functions and options listed in the above table are described in detail in the following sec-
tions.
≥ 100 % NOTE
if the exposure parameter display is red, no more exposures can be made the
following error message appears:
Error 150: Heat Integrator limit - it must be acknowledged with the button.
The colour of the numeric displays for the exposure parameters (kV, mA, mAs, ms) switches
< 90 %
back from red to orange additional exposures are possible.
The colour of the numeric display for the exposure parameters (kV, mA, mAs, ms) switches back
< 80 %
from orange to black additional exposures are possible;
Table 4-2: Display of load limits during exposure
CAUTION
The operator is responsible for a proper positioning of the patient in the radiation
field. He is also responsible to protect adequately those body parts that are exposed
to the radiation field but should not receive X-ray radiation (the knowledge about the
proper usage of the legally mandatory protective equipment is assumed).
CAUTION
The operator has to move away far enough from the radiation field before the
exposure is released. In particular, the protective equipment against radiation
provided for the operator should be used.
Figure 4-3: Text field (11) - turning off the anatomic program
Fluoroscopy operating mode is switched off by selecting another diagnostic device. For exam-
ple:
If the anatomic programs were turned on before turning on the fluoroscopy operating mode, it is
now necessary to turn them off as outlined in section 4.2.1.1.1. - “Anatomic program is switched
on”.
The following table illustrates which exposure technique is available with or without automatic
exposure control (AEC):
without
nique
tech-
With
AEC
AEC
Free
1-point technique
X
Tube voltage selection
2-point technique
X X
Tube voltage and mAs product selection
3-point technique
X X
Tube voltage, tube current and switching time selection
Table 4-4: Available exposure techniques
The GENESIS DT/DTs provides many possible diagnostic devices for selection within its basic
settings. During installation, the selected device should be modified to reflect the actual existing
device:
Urology table
C-arm
NOTE
The above is not intended to be an exhaustive selection list. The list may differ in
your X-ray system due to the actual diagnostic devices installed.
NOTE
Details of controlling fluoroscopy will be described in a separate chapter.
4.2.1.5 Turning on and off Automatic Exposure Control (AEC) / selecting measuring
fields (6)
NOTE
The Automatic Exposure Control (AEC) installed in the GENESIS DT/DTs only
works with measuring chambers that are attached as peripheral devices. Whether a
measuring chamber is installed or not on the device, it must be set during the instal-
lation of the diagnostic device. Up to four measuring chambers can be connected
and selected with the GENESIS DT/DTs generator.
The selection of the measuring chamber is automatic when the diagnostic device is selected
(see Section 4.2.1.3).
The automatic exposure control is switched on by selecting one or more measuring fields using
button (6):
Figure 4-9: Turning on and off automatic exposure control, selecting measuring fields
The actual tube voltage is displayed in the field between the two buttons.
Within the GENESIS DT/DTs settings, you can set how the exposure parameters should be
selected (see section 5.1.3.1). If "Gradation in exposure points" is selected, then the tube volt-
age is graded according to the following table:
In the field between the two buttons of the actual tube current is displayed.
Within the GENESIS DT/DTs settings, you can set how the exposure parameters should be
selected (see section 5.1.3.1). If "Gradation in exposure points" is selected, then the tube cur-
rent is graded according to the following table:
Step mA Step mA
0 10 10 100
1 13 11 125
2 16 12 160
3 20 13 200
4 25 14 250
5 32 15 320
6 40 16 400
7 50 17 500
8 63 18 650
9 80 19 800
Table 4-11: Tube current in the R10 series
The current-time product adjustment is active in the 2 and 3-point exposure techniques
The current-time product is increased in steps of:
For fine parameter gradation: 0.5mAs steps to 10mAs
1mAs steps to 100mAs
5mAs steps to 500mAs
10mAs steps to max. mAs
For gradation in exposure points: according to table 4-13
The current-time product is decreased in decrements of:
For fine parameter gradation: 0.5mAs steps to 10mAs
1mAs steps to 100mAs
5mAs steps to 500mAs
10mAs steps to max. mAs
For gradation in exposure points: according to table 4-13
Table 4-12: Adjustment of the current-time product
In the field between the two buttons, the actual current-time product is displayed.
Within the GENESIS DT/DTs settings, you can set how the exposure parameters should be
selected (see section 5.1.3.1). If "Gradation in exposure points" is selected, then the current-
time product is graded according to the following table:
Step mAs Step mAs Step mAs Step mAs
0 0.5 8 5.0 16 32 24 200
1 1.0 9 6.3 17 40 25 250
2 1.3 10 8.0 18 50 26 320
3 1.6 11 10.0 19 63 27 400
4 2.0 12 13.0 20 80 28 500
5 2.5 13 16.0 21 100 29 600
6 3.2 14 20.0 22 130
7 4.0 15 25.0 23 160
Table 4-13: Current-time product in exposure points
NOTE
For the 3-point exposure technique the tube current is displayed by default. To
switch to display the current-time product, click on the tube current display.
In the field between the two buttons the actual exposure time is displayed.
Within the GENESIS DT/DTs settings, you can set how the exposure parameters should be
selected (see section 5.1.3.1). If "Gradation in exposure points" is selected, then the exposure
time is graded according to the following table:
Step ms Step ms Step ms Step ms
0 1 10 13 20 130 30 1300
1 2 11 16 21 160 31 1600
2 3 12 20 22 200 32 2000
3 4 13 25 23 250 33 2500
4 5 14 32 24 320 34 3200
5 6 15 40 25 400 35 4000
6 7 16 50 26 500 36 5000
7 8 17 63 27 630 37 6300
8 10 18 80 28 800
9 11 19 100 29 1000
Table 4-15: Current-time product in exposure points
4.2.1.10.1 Charge status of the Supercap memory (only GENESIS DTs) – (14)
The charge status is displayed on the graphical user interface if the Supercap energy memory
(GENESIS DTs) is installed. An exposure release in this case is possible only if sufficient power
is available:
The charge of the Supercap energy memory is sufficiently high to allow exposures at full power
normal exposure operation is possible.
The charge of the Supercap energy memory does not allow any more exposures the release of
additional exposures is blocked until the energy memory has been sufficiently recharged.
NOTE
If this status lasts longer than 5-6 minutes, there is a fault in the system (Supercap energy
memory is no longer being charged). If switching the generator on and off once does not rem-
edy this problem contact customer service.
Table 4-16: Charge status of Supercap energy memory
An organ program with a horizontal emitter alignment (90°) is selected and the tube is point-
ing in the right direction exposure can be released;
An organ program with a horizontal emitter alignment (90°) is selected, but the tube is point-
ing in the wrong direction exposure release is blocked;
An organ program with a vertical emitter alignment (0°) is selected and the tube is pointing
in the right direction exposure can be released;
An organ program with a vertical emitter alignment (0°) is selected, but the tube is pointing
in the wrong direction exposure release is blocked;
An organ program with an emitter alignment ≠ 0° or ≠ 90° is selected and the tube basically
points in the right direction exposure can be released;
The emitter alignment is not vertical (0°) and not horizontal (90°). The exposure release is
blocked. However, emitter alignments are still necessary for specific exposure techniques.
In such cases click on this button to enable exposure release for one single exposure (the
colour of the button then changes to green);
Table 4-17: Display of tube position detector (TPD)
The exposure is released by a two-stage manual switch connected to the GENESIS DT/DTs X-
ray generator:
Display Activities
Step 1: Starting the preparation:
This symbol appears at the bottom right hand side of the screen
Starting cathode heating
Starting the rotating anode
Bucky is moved to the starting position (if enabled)
Measuring chamber of the automatic exposure control is reset to zero (if en-
abled)
Measuring chamber of the area dose measurement is reset to zero (if con-
nected)
When all the preparations are complete, the colour of the displayed icon
changes to green - this indicates that the device is ready for the actual exposure
Step 2: Exposure:
Exposure is starting
This symbol is shown at the bottom right hand side of the screen throughout the
exposure.
A continuous audio signal indicates the end of the exposure and the exposure
icon disappears at the same time.
On completion of the exposure all systems are returned to their home positions
The effectively measured exposure parameters are displayed (see Figure 4-14)
Table 4-18: Process of the exposure release
WARNING
The exposure release causes ionizing radiation to be generated and emitted. The
device operator must ensure that both patient and operator are sufficiently protected
from undesired radiation (using radiation protection and keeping a safe distance).
NOTE
The measured area dose is automatically reset before the next X-ray exposure
cumulative area doses are not shown.
NOTE
A detailed set of measured exposure parameters can be accessed via the "System
menu" button (see Section 5.1.2).
Figure 4-17: Text field (11) - turning off the anatomic program
Head Shoulder
Left arm
Neck
Right arm
Left hand
Thorax
Right hand
Abdomen Pelvis
For each body region there are generally multiple anatomic pro-
grams assigned. These are displayed in the text box (11) to the left
of the anatomic selector (13).
The anatomic programs installed by default on the generator are
listed in Tables A-a and A-b in Appendix A.
NOTE
The installed anatomic programs in your system do not necessarily correspond with
the anatomic programs installed by default. They can be modified during installation
to adapt them to the user requirements.
NOTE
The selection of "adult" or "child" programs can always be changed - even if the
anatomic program has already been started. However, in this case, we recommend
clicking on the desired body region again after the change to reload the anatomic
program list.
Standard organ thickness Information for the assessment of the patient (see point )
Selected focal spot size/focus spot Can be changed as described in Section 4.2.1.4
In GENESIS DT/DTs there are three different film/foil combinations programmed by default:
200 ASA Dose to film plane: 5.00 µGy
400 ASA Dose to film plane: 2.50 µGy
800 ASA Dose to film plane: 1.25 µGy
NOTE
The film-foil combinations available in your system may not necessarily coincide with
the preset combinations. These may have been adjusted during installation to the
film/foil combinations in actual use.
Click on the (+) and (-) buttons to switch the pre-programmed film/foil combinations
/ back and forth. The required mAs product will be adjusted to obtain the required dose
to the film plane.
Table 4-22: Setting film/foil combination
This function is used to adjust the threshold of the automatic exposure control for the variable
properties of chemicals used to develop X-ray film images, which turns off the automatic expo-
sure control. The human eye can see differences in blackness only when it has changed by
more than a point of exposure.
The stature button is active when the anatomic programs are on:
For each 1 cm larger or smaller organ thickness, the exposure parameters have to be adjusted
by ± 1 exposure point.
Exception: For the thorax ± 1 exposure point corresponding to ± 1.5 cm of increase or de-
crease of the organ thickness.
NOTE
If the exposure parameters defined in the anatomic programs are close to the
maximum limit of the generator or the X-ray tube, it is possible that the theoretical
available range cannot be fully reached.
NOTE
The fluoroscopy function is optional and may not be supplied with your generator.
Therefore, the following section is only important if you can and want to use this
functionality.
NOTE
When entering the fluoroscopy operating mode for first time after rebooting the con-
trol panel, the software selects "Continuous fluoroscopy" by default. When opened
again the last used operation mode is selected.
10
0
40 50 60 70 80 90 100 110 120 130
Röhrenspannung [kV]
Figure 4-26: Control curve for tube current = function (tube voltage)
Click the "Continuous fluoroscopy" button to switch the mode to pulsed fluoroscopy:
Click the "Pulsed fluoroscopy" button again to switch it back to continuous fluoroscopy.
NOTE
If during the installation of the generator the automatic tube current adjustment was
selected, then changes to the tube voltage will adjust the tube current according to
the programmed control graph.
NOTE
If the automatic dose rate control is enabled, then the tube voltage change buttons
are disabled.
NOTE
If the automatic dose rate control is enabled, then the tube voltage change buttons
are disabled.
NOTE
If the automatic tube current adjustment was selected during installation of the gen-
erator, the tube voltage change buttons are disabled.
Normal dose
High-current fluoroscopy can be selected prior to the start of the fluoroscopy and also during the
fluoroscopy. An audio signal is emitted for the duration of high-current fluoroscopy.
Another click on the “High-current fluoroscopy" button switches it off again. If this feature is not
turned off by the operator, an automatic shutdown after a maximum of 20 seconds occurs (can
be adjusted during installation).
WARNING
The legal requirements for high-current fluoroscopy must be observed.
NOTE
An audio signal is emitted for the duration of high-current fluoroscopy (faster se-
quence).
Table 4-32: On and off switch for the automatic dose rate control
The tube voltage and tube current adjustment is dependent on the control signal based on the
control function specified during installation (see Section 4.2.3.4)
NOTE
If the automatic dose rate control is enabled, then the tube voltage change buttons
are disabled.
Timer has reached the limit of 10:00 minutes, fluoroscopy is automatically stopped:
Function:
Enables another fluoroscopy cycle of 10 minutes for the same patient;
Button is enabled only if a time limit was reached, or if the current fluoroscopy cycle was
interrupted by releasing the foot pedal.
Function:
Measured values of the last fluoroscopy examination are available at the software inter-
face (for details see installation manual);
Fluoroscopy timer and DAP display (if installed) are set to zero.
Table 4-33: Reset and stop button for fluoroscopy timer
Caution
This creates a risk of exceeding the permissible radiation dose (for both pa-
tient and the operator). It is at the user’s discretion to act either for the benefit
of the patient’s safety or for diagnostic benefit.
The tube voltage and tube current are set precisely as described in sections 4.2.3.6 and 4.2.3.7.
WARNING
Starting fluoroscopy means that ionizing radiation is generated and radiated. The
device operator must ensure that both patient and operator are sufficiently protected
from undesired radiation (using radiation protection and keeping a safe distance).
WARNING
It is possible to perform fluoroscopy of patients at higher doses for a limited time, if
required (for example, to improve image quality). The factory setting is 20 seconds
NOTE
This function only temporarily changes the language. On the next system start the
default language that was set during installation will be used again.
NOTE
If the language is to be changed permanently, please inform the service technician.
GENESIS DT/DTs including the control panel with the graphical user interface (GUI) installed
contains the following software packages:
KVC BigBoard 1 (generator control) operating system
OCC BigBoard 2 (control of peripheral devices) operating system
X-Swiss.dll Version of the dynamic link library (connection between the GUI and Win-
dows)
Control Desk Version of the graphical user interface (GUI)
Table 5-4: Installed software packages and their versions
5.1.3.5 Support
The free Teamviewer Quick Support program is installed together
with the GUI (graphical user interface). It enables remote support
of the GENESIS DT/DTs X-ray generator, if the user console or
the computer on which the GUI is installed is connected to the
internet.
NOTE
The system contains the most up-to-date user guide version at the time of delivery of
the system. If you think the user guide is outdated, please contact your service tech-
nician.
5.1.5.2 Saving exposure parameters directly with the Save button (16)
The same function can be also accessed directly on the standard user interface using the Save
button:
select “free technique” or the “anatomic programs”. If the “anatomic programs” are se-
lected, call up the program which is to be modified;
modify exposure parameters;
When this button is clicked, it briefly changes its colour to green. At this time, the time
button needs to be clicked a second time, then the modified
exposure parameters are saved.
6 Scheduled maintenance
ATTENTION
The procedures described below must be observed under all circumstances.
Otherwise, the manufacturer cannot guarantee error-free and smooth operation of
the X-ray generator.
WARNING
Before cleaning, switch off the generator and the control panel.
NOTE
Never use organic solvents, solvent-based cleaners or abrasive cleaners to clean
the generator casing and the control panel.
ATTENTION
Always clean the generator and the control panel with a moist (not wet) cloth.
ATTENTION
Ensure that no liquids can penetrate the generator or the control panel. Liquids can
cause short circuits and damage the device.
ATTENTION
Do not spray the generator under any circumstances.
6.2 Disinfection
ATTENTION
The generator and the control panel must be disinfected by wiping only. This device
is not intended for use in areas which require intense disinfection.
To disinfect the generator use product with a hypochlorite concentration of not more than 3 to
5%, and additionally diluted with water with a ratio of 50:50.
Spray or moisten a lint-free cloth with the diluted disinfectant. The cloth must be moist, not wet.
ATTENTION
Disinfection by spraying is not recommended because the disinfectant may pene-
trate the X-ray generator.
ATTENTION
Disinfection methods must comply with legal disinfection guidelines and explosion
protection requirements.
ATTENTION
If disinfectants that form an explosive gas mixture are used, ensure that these gases
have evaporated before switching on the device again.
ATTENTION
If the disinfection is carried out by fumigation, the generator and the control panel
must be carefully covered with foil before fumigation. Ensure that the generator is
switched off and has cooled down. The foil cover must be removed only when the
disinfectant mist has settled.
ATTENTION
Inspections must be carried out by a professional who has technical qualifications
and is approved by the regulators.
WARNING
The generator must not be operated under any circumstances if during the functional
tests described above any irregularities were found.
6.5 Servicing
ATTENTION
Any service work carried out on this generator must be done exclusively by a
technician with adequate qualifications. It is the only way to ensure that the
generator is working properly.
7 Error messages
Error
Description Possible causes/possible actions Reaction
number
1 Rom test Contact customer service S
2 CAN bus interrupted Contact customer service S
5 Ram test Contact customer service S
Description: the monitoring unit of the internal µ-processor
displays errors.
Cause(s): the firmware does not respond;
6 Watchdog One of the processors is faulty. K
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
7 Checksum setup data Contact customer service S
9 Supply voltage 5V Contact customer service S
10 Supply voltage +-15V Contact customer service S
Description: the internal CAN bus of the generator no longer
operates without problems.
Cause(s): CAN bus connection fault;
CAN bus receiver mes-
14 CAN bus drivers are faulty. K
sage lost
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the internal CAN bus of the generator no longer
operates without problems.
Cause(s): CAN bus connection fault;
CAN bus receiver over-
15 CAN bus drivers are faulty. K
flow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the internal CAN bus of the generator no longer
operates without problems.
Cause(s): CAN bus connection fault;
CAN bus transmitter
16 CAN bus drivers are faulty. K
overflow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the serial interface of the generator no longer
operates without problems.
Cause(s): serial connection fault;
COM connection re-
17 The serial bus drivers are faulty. K
ceiver overflow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the serial interface of the generator no longer
operates without problems.
Cause(s): serial connection fault;
COM connection trans-
18 The serial bus drivers are faulty. K
mitter overflow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the serial interface of the generator no longer
operates without problems.
Cause(s): serial connection fault;
COM buffer receiver
19 The serial bus drivers are faulty. K
overflow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
Description: the serial interface of the generator no longer
operates without problems.
Cause(s): serial connection fault;
COM buffer transmitter
20 The serial bus drivers are faulty. K
overflow
Action(s): switch generator off and on.
If the error message continues to appear con-
tact customer service.
A Appendix
False-
23 AP/PA 24 150 YES 77 63 200 400
profile view
Legend:
ED: Exposure direction
FFD: Focus-film distance
DD: Diagnostic device
BU: Bucky on/off
ET: Exposure technique (1-, 2- or 3-point technique)
U: Tube voltage
mAs: Current - time product
AEC: Selected automatic exposure control
FFS: Film/foil system
NOTE
The pre-installed anatomic programs may not necessarily correspond with the
programs in the list above. The programs on the anatomic programs list are those
that are pre-installed at the factory.
False-profile
59 AP/PA 0 150 YES 66 45 150 400
view
Legend:
ED: Exposure direction
FFD: Focus-film distance
DD: Diagnostic device
BU: Bucky on/off
ET: Exposure technique (1-, 2- or 3-point technique)
U: Tube voltage
mAs: Current - time product
AEC: Selected automatic exposure control
FFS: Film/foil system
NOTE
The pre-installed anatomic programs may not necessarily correspond with the
programs in the list above. The programs on the anatomic programs list are those
that are pre-installed at the factory.