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X-Ray Generator
EDITOR HFe Radiography (RAD)
Editor HFe Fluoroscopy (FLUORO)
Version 06220016
Figure 5-1: Control curve for tube current in relation to tube voltage during
fluoroscopy.......................................................................................36
Figure 6-1: APR panel (standard key assignment) ........................................................ 52
Figure 6-2 Key numbers assignment ........................................................................... 62
Figure 6-3: APR control panel .....................................................................................69
Figure 6-4: Anatomy names ........................................................................................70
Figure 9-1: EDITOR HFe control panel........................................................................ 82
Figure 10-1: Control Panel for EDITOR HFe with fluoroscopy ..................................... 83
Figure 11-1: Touch panel EDITOR HFe ...................................................................... 84
Figure 12-1: Mini Cosole EDITOR HFe ....................................................................... 85
The documentation uses the following references for hazards and peculiarities:
WARNING
This reference is used if a failure to obey the instructions, notes or procedures or a failure
to follow them precisely can lead to injury or lethal accidents.
CAUTION
This reference is used if a failure to obey the instructions, notes or procedures or failure
to follow them precisely can lead to damage to the equipment or external accessories.
NOTE
This reference is used to draw attention to peculiarities.
This symbol warns against moving parts (fans, fluoroscopy option only)
Depending on the field of operation (e.g. life critical applications) the facility should take
backup systems into consideration.
Only authorized and properly trained individuals should operate this equipment. All
individuals authorized to use this equipment must be aware of the danger of excessive
exposure to radiation. The authorized personnel have to hold appropriate certificates which
comply with the local regulatory standards to proof their qualification for operating x-ray
equipment.
The product is intended to be used in medical X-Ray diagnostic / image guidance systems. It
is one part of an X-ray system. It provides power to the x-ray tubes and provides interfaces
for x-ray imaging systems.
The operation is only allowed by personnel with knowledge in X-ray imaging and after
reading and understanding the user manual (In most countries a government certification is
required).
The generator may only be used within medical x-ray rooms and within the rated ambient
parameters (see Chapter 4.6)
The device may not be operated in areas where explosion may be a risk. It must not be
operated near liquids, flammable anesthetics, disinfecting agents, aerosol spray, or in
oxygen-rich environment.
Even if the X-ray generator is switched off, power is present at the line connection and
in the control circuits. For this reason, it is only permissible for trained technicians to
open the generator cabinet or housings of connected controls. Before a trained
technician operates on the generator or the system, the system must be free from
electric tension and currentless. For this, X-ray rooms have an emergency stop button.
CAUTION
Never block or cover the generator cabinet ventilation screen!
Improper handling can lead to overheating and damage to the generator!
3.1.4 Responsibilities
Spellman GmbH Bochum may take the responsibility for the technical safety
characteristics of its products only if maintenance, service and modifications are
performed by personnel specifically authorized to perform such work.
No alteration or modification of any kind may be performed on the device.
Connections and adjustment for installation and integration of a system must be made
according to the service manuals by an authorized service technician.
The generator shall be used by operators with knowledge and training in X-ray imaging and
after reading the operators manual.
3.1.10 Maintenance
The HFe X-ray generator requires proper operation as well as regular care and annual
maintenance/calibration by qualified service personnel familiar with the safety
requirements. Please read also chapter 8 "Maintenance".
3.1.12 Disposal
Spellman GmbH Bochum builds X-ray generators according to state of the art design of safety
and environmental protection. If it is used properly, this equipment does not pose any hazard to
humans or the environment.
Due to the materials used, the X-ray generator should never be disposed together with normal
industrial or domestic waste.
Consult with your Spellman GmbH service partner for local code disposal instructions.
Class I equipment
According to the class of equipment, the Editor HFe X-ray generator
must be referenced to an earth ground by a protective earth conductor.
Failure to provide a separate earth ground can result in electrical shock
hazard causing injury or death.
FDA Warning:
Warning: This x-ray unit may be dangerous to patient and operator
unless safe exposure factors, operating instructions and
maintenance schedules are observed.
Caution!
Always leave
ventilation screen
free
30 90 43 75 [165.35 lb]
The weight values apply to the standard equipment without any options.
[17.91 in]
70 53 45 97 [213.85 lb]
The weight values apply to the
standard equipment without any
options.
Caution!
Always leave
ventilation screen
free
[21.65 in]
Caution!
Always leave
ventilation screen
free
[21.65 in]
CAUTION!!
Always leave
ventilation screen
free!!!
[21.65 in]
[21.65 in]
[25.56 in]
[ in]
Weight: 4kg [8.82lb]
[17.32 in]
[1.97 in]
[10.63 in]
[13.03 in]
[10.55 in]
[2.87 in]
The equipment conforms to protection class I. All conductive parts which can be touched
are connected to the ground connector on the line side.
4.5.1 Table 1
Directives and manufacturer's declaration – Electromagnetic Emissions
The HFe 401-801 X-ray generator is intended for operation in the electromagnetic environment specified below. Customers
and/or users of the HFe 401-801 X-ray generator should ensure that it is used in such an environment.
Emission measurements Compliance Electromagnetic environment - Directives
RF emissions Group 1 The HFe 401-801 X-ray generator uses RF energy
according to CISPR exclusively for its internal function. For this reason, its RF
11 emissions are very low and interference with the use of
electronic equipment is improbable.
RF emissions Class A The HFe 401-801 X-ray generator is intended for use in
according to CISPR other than residential facilities and such facilities
11 connected directly to public low voltage line supply which
is also used for supply of residential buildings.
Harmonics according Class A
to IEC 61000-3-2
The following types of cables for power supply and connecting lines are the minimum
requirements to maintain compliance with electromagnetic compatibility.
4.7 Labeling
Label position 96cm Cabinet (other cabinets are labeled in the same manner)
1a Cabinet only for pretransformer, without all labels inside of the cabinet
0600xxxx
Editor HFe
Z3 ac 3N~50/60Hz, Z4
Standby: Z5
S/n: xxxxx
symbolic description:
• manufacturing company
• serial number of the generator
• manufacturing date
5.1.2.1 General
Various exposure techniques can be selected:
!! WARNING !!
Ionizing radiation!
Exposure has to be accomplished only from the protected area!
Note:
An X-ray exposure can only be made after the generator has completed successfully all
internal safety checks.
The Fluoroscopy is an option that is added to RAD HFe generator. Therefore all the RAD
generator functionalities described above are available with the addition of the functionality
described below for fluoroscopy mode operation.
For fluoroscopy, the following operating modes can be set during installation:
• Fluoroscopy with selectable mA stages
• Fluoroscopy with current depending on set voltage.
The dose rate in the latter mode is highly dynamic (>1000) due to the method of linking the
tube voltage and tube current. The tube current corresponds proportionally to the tube
voltage between the maximum and minimum value. If the tube voltage is increased further,
the tube current remains constant at its maximum value. The control curve for the tube current
in relation to the tube voltage is shown in Fig. 5-1 for the normal range and the range with
higher dose using the default values set at the factory.
The upper and lower points of the control curves can be varied during installation. In the
normal dose range the values are set to (40kV, 0.5mA) and (80kV, 5mA) on a standard basis;
for the higher dose range to (40kV, 1mA) and (80kV, 10mA).
Irradiation of the patient with a higher dose can be switched on for a limited time (default
setting 20s), if necessary for the treatment. The time for irradiation at increased dose can be
adjusted by the service technician during installation, cf. Service Manual.
NOTE:
Always observe the legal regulations concerning fluoroscopy at higher dose rate
for diagnostic purposes.
The generator has the ability to limit the power in fluoroscopy mode based on local
requirements.
CAUTION
As long as the X-ray tube's anode is rotating at high speed, the generator
must not be turned off while the generator is in preparation or exposure
mode.
The high-speed device must slow the speed down before the generator can be
turned off.
The bearings in the X-ray tube can be damaged, if the generator is switched
off before the brake voltage is applied to the anode rotor.
If the generator has accidentally been turned OFF during preparation mode or exposure, it
should be turned on again immediately. The brake voltage will be applied automatically
during power on to the X-Ray tube rotor.
The maximum number of high-speed starts is limited to 4 per minute by the generator for
emergency. Upon exceeding this limit the error number E041 will be indicated.
The tube's maximum allowable number of high-speed starts per minute must not be
exceeded 2 in high speed and 4 in low speed in normal operation.
The first line shows the dose area product with APR.
or
xxxmAs Current/time product in mAs 2-point technique:
Using the VacuDAPduo chamber in fluoroscopy mode the radiography line toggles to display
the following Parameters:
The actual dose rate, the accumulated dose and the accumulated dose area product.
The assignments for keys 32, 39, 23, 24, 38 and 37 are variable, depending on the
equipment
Note:
The HFe Generor automatic tube/generator protection feature only allows setting
combinations of exposure parameter (kV, mA, Time, mAs) values which will not lead to
an overload for the generator or tube, see Chapter 7.3 for error messages. Depending on
the generator model the current and mAs are limited.(See HFe generator model
specifications) Depending on tube model used on the system the generator limits kV, mA
and time based on tube specs.(Tube limit charts are programmed into the generator)
Stage mA Stage 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*1
9 80 19 800*2
*1 EDITOR HFe 501 / *2 EDITOR HFe 601
Table 6-3: Tube current stages in 3-point-technique (19 Stages)
6.7.1 Activation
The automatic exposure control can be activated by selecting an AEC measuring field. A
combination of a number of measuring fields is possible. The selected measuring field is
indicated by an illuminated LED. The AEC control keys are active only when the AEC
option is installed on the gererator.
If the automatic exposure control is activated, additional information on the selected
darkness correction and film-screen system appears in the exposure line.
If exposures are controlled by the automatic exposure control, the exposure parameters
mAs product and exposure time must be set to values larger than expected in 2 and 3-
point technique in order to provide the automatic exposure control with enough time
necessary for switching off the exposure.
NOTE: It is necessary to change the cassette before making a new exposure! Other error
states are also indicated by key No. 28.
!! Warning!!
Ionizing radiation!
Exposure has to be accomplished only from the protected area!
1. Stage: Preparation ON
Key No. X-ray 1, 3
2. Stage: Exposure ON
The exposure control switch has got a two stage construction. When it is pressed half way, it
is Preparation ON. When it is pressed full way, it is Exposure ON. If the switch is released
during the exposure, the exposure is terminated instantaneously (dead man switch).
NOTE: The hand switch should be mounted on the wall in the radiation
protected area!
1. Stage: Preparation ON
2. Stage: Exposure ON
If the hand switch is released during the exposure, the exposure is terminated
instantaneously (dead man switch).
The exposure is terminated under the following conditions:
• When the set mAs product is reached (Manual Mode)
• When the set exposure time is reached (Manual Mode)
• When the automatic exposure control terminates the exposure
6.8.3 Exposures with the external foot switch No. 260– 261 (optional)
An exposure can also be activated by using the external foot switch. The left foot switch
initiates the preparation and fluoroscopy. The right foot switch starts preparation and
exposure for RAD.
NOTE: The foot switch should be located in a radiation protected area. Optionally additional
foot switches may be used.
or
πθ
xxxxx.xcGycm²
A x:xxxkV xxxxmA xxxxms xx xxxFFS
The data collected during the examination can be transferred to a printer (optional) or to a
PC.
Key 36
Key11: APR group 1
Key No. 9 – 11
17 – 19
APR group selection
25 – 27
and 2
The upper line displays the designation of the anatomy in this group; the generator settings
are set to the stored parameters.
If this key is pressed, the type of cast present appears on the display after the organ name.
Pressing this key a number of times scrolls through the settings similarly to the selection of
the exposure technique.
Display Meaning
No display Cast not present
T Half shelf, dry
N Half shelf, wet
°V Full cast, dry
K Plastic half shelf
Table 6-5: Explanation of display for correction if cast is present
Here, the parameter kV is increased by the number of kV points defined for the various types
of casts during installation.
Key No. 9 – 11
17 – 19
Group selection (regions)
25 – 27
and 2
The keys 41/42/43/44/46/47/X-ray 4/45 are required for fluoroscopy. These keys are
located on the fluoroscopy control panel.
kV
Reduction of tube voltage in increments of 1 kV Key No. 41
kV
Increase in tube voltage in increments of 1 kV Key No. 42
mA
Increase in tube current Key No. 44
When the dose rate control is used, the parameters for fluoroscopy are controlled in such a
manner that the image intensifier/dynamic detector is always set to the optimum dose for the
image (Automatic Brightness Control) This assumes that a television circuit is connected to
the dose rate control.
In fluoroscopy mode, i.e. during irradiation, the 'higher dose' function is deselected when the
key is pressed again. If the 'higher dose' function is deselected in the idle mode the unit
switches to 'pulsed fluoroscopy' (F3).
F1 = LCF (normal contrast for fluoroscopy) Low contrast fluoroscopy
F2 = HLF (high contrast fluoroscopy at 'higher dose') High level fluoroscopy
F3 = HCF (pulsed fluoroscopy = optional) High contrast pulse fluoroscopy
If deselecting is not accomplished manually, it switches off automatically after a set time
(default setting 20s).
NOTE:
Always observe the legal regulations concerning fluoroscopy at higher dose rate
for diagnostic purposes.
The current fluoroscopy time is displayed in the info line "Dx:" in minutes and seconds.
During fluoroscopic examination an acoustic signal sounds at intervals of one second and
the radiation display on the control panel continuously signals that radiation is present.
After a fluoroscopic examination time of 5 minutes an acoustic signal with a higher rate
sounds and a yellow LED illuminates in key 45. If there is no reaction to the signal within
the next 30 seconds, i.e. after a maximum time of 5 minutes and 30 seconds, the radiation
is switched off automatically.
To re-enable the radiation it is necessary to release the fluoroscopy key, X-ray 4, on the
control panel or the external foot switch and then confirm with key 45.
After a total fluoroscopy time of 10 minutes the radiation switches off again automatically,
however this time without a previous acoustic warning. In this case it is again
necessary to release the fluoroscopy key on the control panel or the foot
switch and then confirm with key 45 to re-enable the radiation.
The total fluoroscopic examination/treatment time can be reset with the feather key (key 7).
Please note that in this case, the patient memory and log for the examination in progress
are deleted.
Operating mode
Key 8
Key 14 Key 9
Key 13 Key 17
Key 15 Key 18
Key 16 Key 10
Key 19 Key 11
Key 20 Key 23
Key 21 Key 24
Key 22 Figure 6-2 Key numbers assignment Key 12
Key no. Function
1 Tube voltage decrease
2 Tube voltage increase
3 Decreasing the tube current / mAs-product
4 Increasing the tube current / mAs-product
5 Decreasing the exposure time
6 Increasing the exposure time
7 Operating mode selection
8 Focal selection
9 Exposure technique selection
10 Upwards scrolling APR group name
11 Downwards scrolling APR group name
12 Memory key
13 Confirmation key
14 Display information
15 APR group selection
16 APR name selection (max. 100 names)
17 Scrolling thickness - 1cm
18 Scrolling thickness + 1cm
19 Select left measuring field
20 Select centre measuring field
21 Select right measuring field
22 Scroll film-screen-system
23 Decreasing the density by 1 exposure point
24 Increasing the density by 1 exposure point
Bucky table
Small focus
Large focus
3-point-technique: The tube voltage in kV, the tube current in mA and the
exposure time in ms are displayed. The tube voltage, the tube current and
the exposure time can be changed by using the keys 1 and 2, 3 and 4, or
alternatively 5 and 6.
Comment: If in this mode the automatic exposure control is switched on, then a
longer exposure time should be preselected, compared to the one
originally expected for this exposure. This way the automatic exposure
control has enough time to stop the exposure at the right time.
Increase or decrease the tube current in steps defined in Table 6-3: Tube
current stages in 3-point-technique (19 Stages)(active in 3-point-
technique).
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*
* only with large focus using e.g. EDITOR HFe 601
Table 6-3: Tube current steps in 3-point-technology
6.11.7.1 Activation
The automatic exposure control is activated, when a measuring field is selected. The
combination of several measuring fields is possible. The selected measuring field is marked
on the button. If automatic exposure control is activated, it appears in the right-hand display
of the selected film-screen-system and the selected darkness measured in exposure points.
If exposures are controlled by the automatic exposure control, the exposure parameters mAs
and exposure time, in 2- and 3-point technique should be set to a larger value than the one
expected in order to give the automatic exposure enough time to switch off the exposure at
the right time.
Select film-screen-system
This key is only activated if the automatic exposure control is switched on and at least one
measuring field is selected.
COMMENT: The film cassette must be changed before starting a new exposure!
!! Warning!!
Ionizing radiation!
Exposures has to be accomplished only from the protected area!
In the event of a malfunction the X-ray exposure is terminated under the following conditions:
• Automatic exposure control (AEC) mode
o A fault occurs in the AEC
o The initial dose is too high or too low
o At maximum exposure time of 3.2 seconds using 1-point technique
o When the maximum mAs product of 600 mAs is reached in 1, 2 or 3 point
technique
The key 13 switches the display to the information mode. In the display appears the
dose in cGycm². In case of an error the error message is displayed instead of the dose.
The key 14 transfers the data collected during the examination to the serial interface.
The data is automatically deleted.
The data collected during the examination can be transferred to a printer (optional) or
to a PC.
Number of the APR memory ( Group name (29 Adjustment of patient size in
‘*’ if parameters are changed) characters) relation to stored parameters
(keys 17 and 18)
Key „Exit „
The APR can be operated by the keys 1 –10 or by the dot buttons (keys 170-179). After
pressing one of these keys the main menu appears again showing the first anatomy name in
the selected APR group. The generator settings are set to the stored parameters.
The APR control panel can be left by using the “Exit“ key.
Key „Exit „
The anatomy technique names can be selected by using the keys 00 – 99. By using the
arrow-keys, you may scroll through the APR group in steps of 10 or 20 anatomy technique
names. After an anatomy name is selected, the display returns to the main menu showing
the stored parameters of the selected APR setting.
The anatomy name selection menu can be left by using the “Exit“ key.
By pressing one of these keys either ">xxcm" or "<xxcm" appears on the display. This way
the parameters kV and mAs are changed by one step per cm. The parameter steps are
shown in the five tables below. During the installation each APR group has to be assigned to
one of these tables.
The cm correction is limited to a maximum of ±10 cm. If the stored exposure parameter
values are reaching the generator's operation limits, it may happen that this range cannot be
used completely.
First it is necessary to select a group and then the anatomy for which the new exposure
parameters are to be saved.
The new parameters can then be set. Pressing the „M“ key twice saves them.
M Press key again and the parameters are saved Key No. 12
AEC- Device
Organ Designation kV mAs Focus Screen
Field
00 Warm up 70 100 large 400 - non
01 OSG a.p. 48 6.3 small 400 - non
02 OSG lat. 46 4 small 400 - non
03 Calcaneus lat. 46 2.5 small 400 - non
04 Calcaneus axial 48 3.2 small 400 - non
05 Foot d.p. 46 2 small 400 - non
06 Foot oblique 46 3.2 small 400 - non
07 Forefoot d.p. 44 2.5 small 400 - non
08 Forefoot oblique 42 2 small 400 - non
09 Big toe d.p. 44 1.2 small 400 - non
10 Skull p.a. 70 25 large 400 C yes
11 Skull lat. 66 16 large 400 C yes
12 Skull sinus demiaxial 73 32 large 400 C yes
13 Skull sinus lat. 66 12 large 400 C yes
14 Nasal bone 60 1.6 small 400 C yes
15 Lower jaw 66 4 large 400 C yes
16 Dens (mouth open) 70 25 large 400 C yes
17
18
19
20 Column cervical v.d. 66 16 large 400 C yes
21 Column cervical lat. 63 16 large 400 C yes
22 Column cervical oblique 66 16 large 400 C yes
23 Column cervical (Mandible) 66 16 large 400 C yes
24 Column cervical Inkl. & Rekl. 63 16 large 400 C yes
25 Column lumbar a.p. 73 125 large 800 C yes
26 Column lumbar lat. 85 125 large 800 C yes
27 Column lumbar oblique 66 125 large 800 C yes
28 Column thoracic a.p. 32 80 large 400 C yes
29 Column thoracic lat. 80 200 large 400 C yes
30 Shoulder a.p. 66 8 small 400 - yes
31 Shoulder axial 60 3.2 small 400 - yes
32 Shoulder transthoracal 77 20 small 400 - yes
33 Shoulder I/A/E 66 6.3 small 400 - yes
• When X-ray is ON, the X-ray exposure radiation indicator on the control panel
illuminates continuously.
• In the event of an incorrect exposure, the yellow LED in key No. 28 illuminates.
Please obey the instructions/actions for each specific error. If actions are not taken by the
operator, additional damage can be caused to the generator.
CAUTION
Even if the generator is switched off, parts on the inside of the generator
cabinet and connected controls are powered! Only allow trained service
personnel to open the generator cabinet or housing of connected controls!
Improper handling may cause lethal hazards!
The X-Ray tube needs to be warmed-up daily in order to extend the life of the tube and
prevent tube arcs. (Especially when the X-Ray tube was not used for a long period) The
seasoning procedure shall be done upon turning on the generator or if the generator was not
used for 8 hours.
Follow X-Ray tube manufacturer's recommended seasoning procedure.
If X-ray tube manufacturer’s seasoning procedure is not available, then use the following
procedure:
Set HFe Generator: large focal spot, 200 mA, 40mAs.
Take 8 exposures starting at 50kV and increment the kV in steps of 10KV up to 120kV
(Exposure every 30 seconds, otherwise tube may arc)
8.2 Cleaning
Make sure the X-ray generator is OFF before cleaning the enclosures.
Never use abrasive cleaning agents, organic solvents or cleaning agents
containing solvent.
Clean the generator with a moist rag.
Ensure that liquids do not get into the generator. This can cause short circuits. Do not spray
X-ray generator with liquids.
8.3 Disinfection
The method used for disinfection must satisfy the legal regulations and guidelines
(disinfection, explosion protection).
NOTE:
Make sure the X-ray generator is OFF before cleaning the enclosures.
If you use a disinfectant, which can form explosive gas mixtures, switch the
generator back on only after these have been evaporated.
If any liquid was spill on the operating console do not turn on generator
until liquid dried out.
Never use disinfection sprays, because the spray could get into the inside of the
equipment.
NOTE:
Always perform legally prescribed tests at the specified intervals.
Qualified service personnel should accomplish a safety test at least once a year. The
following maintenance and service work should be performed.
• Clean high-voltage plug on tube and transformer and plug back in using new
insulation according to the recommendation of the high voltage cable supplier.
Hand switch
Hand switch
Foot switch
Hand switch
Power
ON/OFF
indicator LED
Radiation
indicator light
PREP Ready
Indicator LED
Preparation Exposure
(PREP)Button Button