Professional Documents
Culture Documents
Document Version
Siemens reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents cor‐
respond to the version at the time of system delivery and/or printout. Versions to hard‐
copy documentation are not automatically distributed. Please contact your local Siemens
office to order a current version or refer to our website http://www.health‐
care.siemens.com.
Disclaimer
Siemens provides this documentation “as is” without the assumption of any liability under
any theory of law.
The content described herein shall be used by qualified personnel who are employed by
Siemens or one of its affiliates or who are otherwise authorized by Siemens or its affiliates
to use such documents.
Assemblers and other persons who are not employed by or otherwise directly affiliated
with or authorized by Siemens or one of its affiliates are not entitled to use this documen‐
tation without prior written authority.
Copyright
“© Siemens, 2006” refers to the copyright of a Siemens entity such as:
Siemens Healthcare GmbH - Germany
Siemens Aktiengesellschaft - Germany
Siemens Shenzhen Magnetic Resonance Ltd. - China
Siemens Shanghai Medical Equipment Ltd. - China
Siemens Medical Solutions USA Inc. - USA
Siemens Healthcare Diagnostics Inc. - USA and/or
Siemens Healthcare Diagnostics Products GmbH - Germany
1 General information 5
2 Installation 14
2.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.1 SIREMOBIL and monitor trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.2 ARCADIS Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.3 MODULARIS Uro Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.4 SONOLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.5 Unpacking MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.6 Docking unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.1.7 Connection, e.g. to ARCADIS Orbic / ISO C . . . . . . . . . . . . . . . . . . 22
2.1.8 Unit association - labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.1.9 C-arm unit isocenter cross. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.1.10 Installing the isocenter cross on the C-Arm. . . . . . . . . . . . . . . . . . 27
2.1.11 External isocenter cross manufacturer . . . . . . . . . . . . . . . . . . . . . 28
2.1.12 Radiation release option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.1.13 MODULARIS Uro Table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
2.1.14 ECG triggering option (VARIOSTAR 101 42 974) . . . . . . . . . . . . . 31
3 Startup 35
Bei einer Gefahr, die bei Nichtvermeidung zum Tod oder zu einer
schweren Körperverletzung führen kann.
WARNING
Danger of injuries, death or material damage.
Non-compliance can lead to death, injury or material damage.
Please note:
The product-specific safety information in these instructions,
The general safety information in TD00-000.860.01... and
The safety information in accordance with ARTD Part 2.
WARNING
Electrical safety!
Non-compliance can lead to severe injury or even death, as well as material dam‐
age.
Parts under electrical voltage are accessible when the covers are open. To
avoid danger, disconnect the system from the power supply before opening
the covers. Disconnect the power plug.
If an uninterruptible power supply (UPS) is installed in the system, the voltage
output of the UPS must also be deenergized or the voltage output plug must
be disconnected.
If work steps must be performed using electrical power, the general safety in‐
formation according to TD00-000.860.01... must be observed.
WARNING
X-ray radiation!
Non-compliance can lead to illness, irreversible damage to body cells and the gen‐
otype, severe injury and even death.
During work on the system in which radiation must be released, the radiation pro‐
tection directives and the rules for radiation protection according to
ARTD-002.731.02... must be complied with.
Please note:
X Use available radiation protection devices.
Wear radiation protection clothing (lead apron).
Stay as far away as possible from the radiation source.
Release radiation only if necessary.
Set the radiation activity as low as possible. (low kV and mA values, short radi‐
ation time)
Release radiation for as short a time as possible.
Checks requiring the release of radiation are identified by the radiation warn‐
ing symbol shown on the left.
These measurement values as well as the values determined during start-up can be cop‐
ied from the test certificate to the acceptance certificate.
2.1 Overview
2.1.4 SONOLINE
NOTICE
Risk of damage
Do not pull on the focus phantom (bracket ( 1/Fig. 3 Page 14)).
Do not use the phantom as a handle.
n Disconnect the yellow transport safety bracket ( 1/Fig. 4 Page 15) that secures the
device from both sides.
n Remove all the other transport brackets ( 2/Fig. 4 Page 15) and pull out the wooden
braces from underneath the unit by applying and then releasing the brake
( 3/Fig. 4 Page 15).
n Remove the ramp and set it at the rear side, securing it from slippage.
n Carefully move the unit off the transport pallet and down the ramp.
n Appropriately dispose of the packaging according to the country-specific regulations.
n Adapt the power cord to the country-specific requirements, if required. If necessary,
materials will have to be purchased locally. Use a hospital grade plug for the USA and
for Canada.
n Connect the control panel.
This chapter first describes mechanical coupling for Variostar in combination with SIRE‐
MOBIL Compact .
The procedure is the same for all C-arm units. Mechanical installation of the bridge on
the front extension of the C-arm unit must always be adapted. Technical clarification
must be known and in conformance with PG (SPL1-130.890.20...).
For the sake of clarity regarding technical work on all components, the coordinates used
in this document are defined in this diagram: ( Fig. 5 Page 17) (Variostar with shock
wave focus, C-arm unit with isocenter, patient table). For the Variostar and C-arm unit,
the designations "left" and "right" are always from the viewpoint of the operator with the
unit moving forward.
The docking mandrel is pre-installed on the Variostar centrally in relation to the longitudi‐
nal axis ( 1/Fig. 5 Page 17) and can be adjusted by 30 mm in height (200 to 230 mm
above the floor). The height is determined depending on the installation of the docking
bridge. The docking bridge is installed centrally (± 4 mm) on the front C-arm unit exten‐
sion ( 2/Fig. 5 Page 17).
The following figures are not displayed to scale, and apply to the Variostar with Sir‐
emobil ISO C / Compact and the Compact L/ ARCADIS Family. Any other C-arm unit
requires prior clearance by the local project management. The procedure is then
the same.
n Prepare the Variostar to the left of the C-arm on a level floor (fix C-arm)
n Set the C-arm vertically to approx. 1070 mm in the center (( 3/Fig. 5 Page 17)_ Z di‐
rection)
n Remove the top part of the docking bridge.
n Unscrew the docking bridge ( 1/Fig. 6 Page 17) or detailed view ( 1/Fig. 7 Page 18)
and pull the docking bridge apart so that the complete adjustment range is available.
n Place the bottom part of the docking bridge on the C-arm extension, at least 140 mm
in the X direction ( 1/Fig. 9 Page 19) and centered (± 4 mm).
For Siremobil ISO C with serial number 1024 - 1687 the interface and the internal
cabling must be retrofitted as described in the document SPL 1-130.814.03 (Modu‐
laris Uro Plus). Serial numbers 1024 and lower cannot be retrofitted. Siremobil
Compact serial numbers < 4150 and Compact L < 1702 must also be retrofitted. Also
refer to the instructions for Modularis Vario Adaption SPR2-130.814.05.
For ARCADIS Orbic / ISO C, the docking bridge has to be adapted accordingly
( Fig. 13 Page 21).
n Remove both clamping screws ( 3/Fig. 8 Page 18).
n Screw the clamping screws from the enclosed material into the fastening block
( 1 und 2/Fig. 13 Page 21).
n Attach these blocks to the bridge with 2 screws ( 3/Fig. 13 Page 21).
n Position the docking bridge according to ( Fig. 14 Page 22).
n Horizontally position the docking bridge with the adjustment screw
( 1/Fig. 14 Page 22) (or see ( 2/Fig. 7 Page 18) for more detail).
n Position the top part of the docking bridge and secure it ( 1/Fig. 12 Page 21).
n Test the inward movement and locking of the Variostar. The latch must lock securely.
Correction is performed using the black Allen screw in the latch ( 2/Fig. 12 Page 21).
If the docking bridge is not fastened with screws, it can be removed whenever necessa‐
ry. This will prevent the C-arm from colliding with the docking bridge in the event of a
"non-lithotripsy application."
When the Variostar is used with the Orbic C-arm, the warning labels included with deliv‐
ery must be affixed to the docking bridge and the table, as shown in the illustrations.
(1) Variostar_serial_number
(2) Manufacturer and type, C-arm unit
(3) C-arm_unit_serial_number
(4) C-arm_unit_serial_number
(5) Variostar_serial_number
Fig. 24: Installation, isocenter cross_01 Fig. 26: Installation, isocenter cross_02
The radiation release option of the Variostar operating panel is released only for Siremo‐
bil Compact L and ARCADIS Varic / Orbic.
Fig. 33: ECG monitor installation 1 Fig. 34: Installing the ECG power supply
3.1.1 Location
Menu guidance in the display is implemented with tab cards whose arrangement and
content are based on the typical procedure of urological treatment.
(1) Dynamic menu key; current key assignment is shown on the display
(2) Menu navigation keys (up/down arrow keys) and parameter input keys (left, right arrow keys)
(3) Confirmation key for executing the selected menu entry
(4) Key for releasing shock waves
(5) Key for radiation release (digital radiography); only available with a Siemens C-arm (ARCADIS Varic, ARCADIS
Orbic/3D, SIREMOBIL Compact L, SIREMOBIL Iso-C3D)
(6) Key for releasing radiation (fluoroscopy)
NOTICE
Liability for the complete therapy system.
If no documents covering the above points are available, the combination
with MODULARIS Variostar may not be implemented!
With the SIREMOBIL Compact and ARCADIS Varic, radiation can be triggered from the litho
module control panel. Use instructions SPR2-130.814.05... and tool kit 7140952 (depend‐
ing on the SIREMOBIL serial number) for this purpose. With non-Siemens C-arms, radia‐
tion cannot be released from the litho module.
Adhere to the MODULARIS Uro operator manual and the safety information contained
therein (Safety register).
Preparing coupling
Before coupling the X-ray C-arm, the patient table must be moved sideways via the MOD‐
ULARIS Uro hand-held remote control.
Fig. 44: MODULARIS Uro hand-held remote con‐ (1) Moves the patient table longitudinal‐
trol
ly in headward
direction, footward direction
(2)
Moves the patient table laterally
toward the table cutout, away from
the table cutout
(3)
Raises the patient table, lowers
the patient table
(4)
Tilts the patient table
to reverse Trendelenberg position, to
Trendelenberg position
(5)
Moves patient table to upper or low‐
er
basic position
(6)
Coupling position
Fig. 45: Coupling position
n Move the patient table sideways, away from the table cutout.
- The C-arm can be moved in more easily in this position.
n Remove the table cutout.
Observe the instructions in the operator manual of the X-ray C-arm and the safety infor‐
mation contained therein.
CAUTION
The crosshair disk could fall.
Risk of injury!
After assembly, ensure that it is secure.
In the case of LithoShare, only the crosshair disk assigned to the X-ray C-arm in use may
be installed. The serial numbers on the labels on the image intensifier and on the cross‐
hair disk must match.
With the Lithoreport option (ARCADIS Varic, ARCADIS Orbic) no crosshair disk is installed
because the crosshair is displayed digitally via the imaging system.
n Align the triangular marker of the crosshair disk with the one on the image intensifier.
n Attach the crosshair disk to the image intensifier.
- The spring clips of the crosshair disk must snap audibly into the recess in the image
intensifier when pressed.
n Ensure that the crosshair disk is securely in place.
n Align the triangular marker on the spring clip of the crosshair disk with the one on the
image intensifier.
n Attach the crosshair disk to the image intensifier with the rigid hooks.
n Press the spring clip back against the resistance until the crosshair lies fully on the im‐
age intensifier and then carefully release the spring clip.
n Ensure that the crosshair disk is securely in place.
Switching on
n Connect the X-ray C-arm to the power supply plug of the monitor trolley.
n Connect the monitor trolley to the line voltage.
n Switch the X-ray C-arm system on.
n Move the swivel, angulation, and orbital position of the X-ray C-arm to the 0˚ posi‐
tion. Lock the brakes again.
- When using SIREMOBIL Iso-C, SIREMOBIL Iso-C3D, or ARCADIS Orbic/3D, the triangu‐
lar marker of the C-arm guide must match the triangular marker on the C-arm ex‐
actly.
n Move fully in the horizontal travel direction and lock the brake.
CAUTION
Insufficient alignment of the C-arm or coupling of a C-arm with an insufficient C-
shape (third-party manufacturer).
Damage to the support arm and the C-arm caused by collision!
Be particularly careful when using C-arms from other manufacturers.
Align the C-arm very carefully.
n Release the foot brakes and move the X-ray C-arm to the adjusting device of the pa‐
tient table.
Pay attention to exact positioning of the C-arm in relation to the adjusting device. Unfav‐
orable positioning of the C-arm system and table reduces the safety distances during
lithotripsy operation and can require additional radiation exposure during X-ray localiza‐
tion operations. The coupling procedure may have to be repeated.
n Move the X-ray C-arm and cross-arm to the end stop in the docking tunnel. Use the
adjusting device for fine positioning.
Pay attention to the C-arm height during insertion into the docking tunnel.
Under certain circumstances, it is necessary to raise the ends of the adjusting device so
that they meet the intended position of the docking tunnel.
n Move the support arm and the shock wave head to the basic position for UT with the
shock wave head in the 50˚ orbital position.
n Check for correct locking in the end positions.
n Open the locking lever of the docking tunnel on the X-ray C-arm by turning it counter‐
clockwise.
n Open the transparent doors on the front side of the MODULARIS Variostar and fold out
the coupling arm by lifting the lock.
n Close the transparent doors.
n Use the coupling arm (1) to move the MODULARIS Variostar to the end stop in the
docking tunnel (2) of the X-ray C-arm.
The coupling arm must lock perceptibly into place.
Ensure that the shock wave head does not collide with the tabletop and that the support
arm does not collide with the C-arm.
n Lock the locking brake on the MODULARIS Variostar by stepping on the pedal.
- Press the pedal until the end position is reached (locks in place).
- The feet of the device box extend.
When using X-ray C-arms from other manufacturers, MODULARIS Variostar cannot be
connected to the X-ray C-arm. As a result, X-ray images cannot be generated or stored
via the handheld remote control. For this purpose, use the control of the respective X-
ray C-arm.
Patient table
n Coil the cable with the plug marked in gray in the cable compartment of the MODULA‐
RIS Variostar.
n Run the cable through the cable gap and out of the cable compartment.
Siemens C-arm
n Run the cable with the plug marked in yellow through the cable gap and out of the
cable compartment of the MODULARIS Variostar.
n Connect the cable to the front of the Siemens X-ray C-arm.
- This connection facilitates the generation and storage of X-ray images via the MOD‐
ULARIS Variostar handheld remote control.
n Additionally, for ARCADIS Varic and SIREMOBIL Compact L, connect the cable marked
in blue for the C-arm angulation motor drive (if present).
3.3.5.4 Switching On MODULARIS Variostar
CAUTION
Control of the X-ray C-arm and the patient table is activated via the MODULARIS
Variostar hand-held remote control.
Unintentional radiation release, C-arm angulation, or table movement possible!
Make sure that the keys of the hand-held remote control are not pressed inad‐
vertently.
n Move the support arm and the shock wave head to the basic position for UT with the
shock wave head in the 50˚ orbital position.
n Press the two sliders on the side of the focus phantom in the direction of the arrow
and fold the focus phantom bracket up.
n Allow the focus phantom bracket to snap audibly into place and ensure that it is se‐
cure.
n Make sure that the orbital movement of the X-ray C-arm is locked in the 0˚ position.
Fig. 63: Check adjustment 2
CAUTION
Move the X-ray C-arm out of the adjustment position.
Patient subjected to unnecessary shock wave application due to an incorrect fo‐
cus position!
Check the locking of the following movement directions:
- Orbital movement (locking in 0˚ position)
- Horizontal swivel
- Horizontal travel
- Vertical lift
During lithotripsy treatment, the only allowable movement of the X-ray C-arm
is angular.
Focus phantom
n Press the two sliders on the side of the focus phantom in the direction of the arrow
and fold the focus phantom bracket back into the locking position.
X-ray C-arm
If all the work steps described up to this point for non-Siemens C-arms have been suc‐
cessfully completed, please fill out the fax for release of operation and send it (release
for operation, initial start-up, SPL1-130.815.01...). Release can then be available by the
time of handover to customer.
This individual release is always required, regardless of the C-arm manufacturer (includ‐
ing Siemens units).
NOTICE
The table may only be moved using the motor if it is in the working position.
This means that the foot lever is in the "braked" position (see the MODULARIS
Uro operating instructions).
n Connect the cables between the MODULARIS Variostar and MODULARIS Uro.
n Move the table into Litho mode and check the table movements with the MODULARIS
Variostar control panel. The following motorized movements are possible from the
MODULARIS Variostar control panel:
Table movement in the Litho mode (green LED on the table control panel goes on)
e.g. key for longitudinal movement pressed.
Table movement approx. 2-3 mm - stops for approx. 2-3 seconds - and then con‐
tinues movement without pausing.
n Attach the connector adapter ( 1/Fig. 76 Page 63) to the serial interface (RS 232) and
secure the screws.
n Install software version V1.0.302 or higher in the SONOLINE G20 (see the SONOLINE
G20 operating instructions, chapter 4).
n Enable ultrasound localization (refer to the Chapter "Ultrasound localization").
The following section outlines the work steps for the old D3, serial number < 3000.
The following section outlines the work steps for the US connection of the new D3 board
(10142950), serial number 3000 and higher.
n Attach the "MODULARIS Litho" label (included with shipment) to the monitor of the
ultrasound unit ( 1/Fig. 89 Page 71) (this label is used to identify which ultrasound
unit is functioning with the MODULARIS Variostar).
SONOLINE G20
Fig. 90: SONOLINE G20
n Screw the connector adapter ( 1/Fig. 90 Page 72) to the serial interface.
n Install software version V1.0.302 or higher in the SONOLINE G20 (see the SONOLINE
G20 operating instructions, chapter 4).
n Enable ultrasound localization (Chapter: “Selecting the MODULARIS cross on the SO‐
NOLINE G20" in this document).
n For ultrasound localization, a mount for an ultrasound probe is installed on the shock
wave head.
Only the following probes can be used:
n Deselect the screensaver on the SONOLINE G20 (see the SONOLINE G20 operating
instructions).
n A cross is displayed when a probe is selected.
3.5.4.1 Preparations
Only approved probes may be used for the corresponding SONOLINE. When installing
the probe in the holder, tighten the screws equally (see figure). The holder and probe
may not be offset.
n Install the mount ( 1/Fig. 92 Page 74) (see also operating instructions).
n Insert an ultrasound probe (array probe) ( 2/Fig. 93 Page 74) into the mount
( 3/Fig. 92 Page 74). Carefully lay the cable for the probe in the long slot
( 4/Fig. 92 Page 74) and carefully secure it.
n Plug in the cable ( 2/Fig. 92 Page 74) and connect the probe to the ultrasound unit.
n Establish the line connection (marked orange) between the MODULARIS Variostar and
the ultrasound unit.
The button designations can vary depending on the language version.
See the SONOLINE operating instructions for a comparison table.
n Set the value ( 1/Fig. 95 Page 76) to 180 with the "image field/zoom" knob.
n Slide the ultrasound probe all the way forward to the shock wave head.
n Press the "Measurement" key and select the "Set" measurement marker.
n Use the track ball to move to the center of the crosshair. A value of 13 mm ± 1 mm
( 2/Fig. 94 Page 75) must appear in the display ( 2/Fig. 94 Page 75) .
n Press the "Measurement" key ("Freeze" is deselected).
n Move the ultrasound probe all the way in the other direction (acoustic signal).
n Use the trackball to position the crosshairs on the upper cross, click the "Measure‐
ment" button and select the "Set" measurement marker.
n Press the "Measurement" key and select the "Set" measurement marker.
n Use the track ball to move to the center of the crosshair. A value of 151 mm ± 1 mm
must appear in the display ( 2/Fig. 95 Page 76).
If this is not the case, the adjustment procedure must be repeated for the potentiome‐
ter in the ultrasound arm or the ultrasound arm must be replaced.
The isocenter (spherical echo) must be checked with every probe type and every time a
probe is replaced.
n Check whether the isocenter phantom ( 1/Fig. 96 Page 77) is filled with water. If not,
remove the screw ( 2/Fig. 96 Page 77) and fill in water with a syringe
( 3/Fig. 96 Page 77). There may not be any air bubbles. Screw in the screw again.
n Lift up the isocenter phantom.
n Fill the water bladder with water (about 60 ml ) ( 1/Fig. 97 Page 77):
1. - Fill a syringe with distilled water. Remove any air that may be trapped in the sy‐
ringe.
- Insert the syringe needle through one of the valves ( 2/Fig. 97 Page 77) and in‐
ject the contents of the syringe into the water bladder. The valve has a self-closing
membrane.
- Repeat the fill operation until the water bladder is completely filled with water.
- After filling, there may not be air bubbles in the water bladder. Remove any air
bubbles with the syringe.
Each activation of the "Set" key increases the value by +1. The "Select" controller allows
the value to be changed in both directions.
n Check whether the ultrasound arm is positioned as shown in ( Fig. 92 Page 74). If
not, position it accordingly. The long slot must be visible ( 1/Fig. 99 Page 79).
n But‐ key twice ("+1" cross is not necessary for this measurement).
ton
n Using the track ball, move the measurement crosshair to the middle of the spherical
echo. If necessary, reduce the brightness with the 2 D-knobs until the spherical echo
pos. 1./( Fig. 100 Page 80) is clearly visible.
n Button key.
n Use the track ball to move the "+2" cross along the longitudinal (vertical) axis to the
center of the the target cross.
n Press key.
the
n The value displayed for "D2" must be between 1 and 5 mm. This is only valid for the
default values, see instructions SPL1-130.038.01... .
n Press key.
the
n Press key twice ("+1" cross is not necessary for this measurement).
the
n Using the track ball move the "+2" cross onto the center of the spherical echo.
n Press key.
the
n Using the track ball move the cross into the center of the target cross.
n Button key.
- Check the deviation; if white area is not in the center of the isocenter, repeat the
procedure.
Also check the central position of the spherical echo to the target cross
with the probe turned 90˚.
If the tolerance is not maintained, check the screw connections between the shock wave
head and US holder and probe and the probe sleeve. If the holder is damaged it must be
replaced. The focus phantom must also be checked and replaced if damaged.
n After the adjustment check the US arm at the second installation position of the
shock wave head. ( 7/Fig. 92 Page 74) . For each probe, check whether the adjust‐
ment in this position is also OK. Do not make any change to the image tilt adjust‐
ment.
n Following the check, store the parts in the appropriate transport cases.
The retrofit enables a second, lower table position, which is required for the application
"Variostar in overtable position".
If the MODULARIS Uro is included in the delivery volume of the Variostar, this work has
already been performed at the factory.
NOTICE
Electrical voltage!
V
Disconnect the MODULARIS Uro from line voltage prior to working on the ta‐
ble.
NOTICE
Risk of injury!
NOTICE
Fill out the protocols.
After completing all adjustments and measurements, the responsible service
engineer should confirm that all the values have been correctly measured and
recorded in the measurement protocols by signing his name and the date
(system, generator and IQ measurement protocol).
healthcare.siemens.com/services
siemens.com/healthcare