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reserved.
English
Doc. Gen. Date: 02.05
2003
2Revision / Disclaimer
1Revision / Disclaimer
Document revision level
The document corresponds to the version/revision level effective at the time of system
delivery. Revisions to hardcopy documentation are not automatically distributed.
Please contact your local Siemens office to order current revision levels.
Disclaimer
The installation and service of equipment described herein is to be performed by qualified
personnel who are employed by Siemens or one of its affiliates or who are otherwise
authorized by Siemens or one of its affiliates to provide such services.
Assemblers and other persons who are not employed by or otherwise directly affiliated
with or authorized by Siemens or one of its affiliates are directed to contact one of the
local offices of Siemens or one of its affiliates before attempting installation or service procedures.
MODULARIS Litho VarioSPL1-130.814.02.07.02Siemens AG
02.05CS PS 24
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Medical Solutions
Table of Contents3
1-0Table of Contents
1 _______ General information______________________________________________ 5
7 _______ Changes to previous version _____________________________________ 87
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Medical Solutions
General information5
1General information
2-
Important start-up information0
The device was installed, programmed, and tested at the factory (see the test certificate
filed in the “technical documentation” system binder).
During start-up, you will only need to perform a few tests or measurements to ensure that
none of the settings have changed.
All measurement results from measurements labeled with p must be entered in the
test certificate listed in each instance.
NOTE
These measurement values as well as the values determined during start-up can be copied from the test certificate to the acceptance certificate.
Applicability and regulations for regional companies0
Equivalent leakage current measurement
The equivalent leakage current must be measured where applicable under the requirements of DIN VDE 0751 Part 1.
Where DIN VDE 0751 does not apply, the regional companies should comply with the following regulations (refer to ARTD - 002.731.17, Safety-related regulations for installation
and maintenance).
The national regulations apply primarily for the regional companies.
In the event that there are no existing regulations, the following provisions should be
adhered to in the interest of the safety of customers, patients, employees and third parties
as well as the company.
Initial measured value
The equivalent leakage current measurement was performed at the factory and the value
measured was entered in test protocol 1. The measurement was made at the line voltage
and line frequency indicated in test protocol 1.
If the on-site line voltage or line frequency deviates from the information indicated upon
delivery, the values given are invalid. The values should be marked invalid (crossed out
with the comment “invalid values“ and this copy should be signed and dated).
The equivalent leakage current measurement must be repeated. According the DIN VDE
0751 Part 1, the resulting value may not exceed 1 mA.
The initial measured value must be documented.
Repeat measurements
When service or repair work is performed on the primary power supply circuit (e.g. repairs
to the power-on circuit), the equivalent leakage current test must be repeated. The values
measured in the subsequent test may not exceed the threshold value of 1 mA as specified
in VDE 0751, Part 1. In addition, they may not exceed the initial measured value by more
than 50%. If the value exceeds this threshold, the system must be repaired. The measured value must be documented.
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6General information
MODULARIS Vario overview0
MODULARIS Vario0
Fig. 1:Vario
Pos. 1Shock wave head C plus with 140 mm penetration depth with adapted isocenter phantom.
Pos. 2Therapy arm incl. head
Pos. 3Energy charger with fast high voltage switch
Pos. 4Docking system with docking mandrel
900 mm
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Medical Solutions
General information7
Required technical documents0
•Start-up, release for operationSPL1-130.815.01..
•* Dimension certificate from the PGSPL1-130.891.01..
•MODULARIS Vario service instructionsSPL1-130.840.01..
•**C-arm unit installation instructionsn.a.
•**Monitor trolley installation instructionsn.a.
•**C-arm unit start-up instructionsn.a.
•**LITHOSTAR MODULARIS Vario adaptationSPR2-130.814.05..
•MODULARIS Uro Plus operating instructionsSPL1-130.620.01..
•MODULARIS Vario operating instructionsSPL1-130.620.05..
•C-arm unit operating instructionsn.a.
•Service instructions for shock wave pressure and po-
sition control
* Only in combination with a non-Siemens C-arm unit.
**Only in combination with Siemens C-arm units.
SPL2-120.074.01
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8General information
Required tools and measurement devices0
•Standard installation tool kit
•Service PC, see intranet, service laptop for CSEs
•PC connection cable, 5m99 00 440 RE999
•Internal line resistance meter84 28.104 RE999
•ESD equipment
•Protective conductor tester44 15 899 RV090
•DVM, e.g.. Fluke 18799 94 831
•Pressure test device30 95 408 J1008
•Adapter for C-head98 17 347 J1008
•Bender safety tester97 06 979 Y0526
•Spray can or varnish applicator of the color white grained
MED surface no. 4146 similar to RAL grayish white 9002.
99 00 705 RE999
Required material0
•Approx. 5 liters of sterile water
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Medical Solutions
General information9
Protective measures0
•Adhere to the protective measures described in register 1 of the system binder.
•When performing the work steps, the product-specific safety information contained in
the document as well as the general safety information in ARTD, Part 2 must be observed.
•Observe ESD guidelines!
WARNING
Dangerous X-ray radiation and/or dangerous electrical voltage
during test and adjustment operations!
Disregarding safety precautions can result in death or serious
bodily injury.
¹ The following points must be observed:
¹ Disconnect the power cable when working on the sys-
tem.
¹ Ensure compliance with the general safety requirements
when working with the system under power.
¹ Switch off the power prior to replacing modules or
boards.
¹ After all work has been completed and all covers have
been installed, perform the protective conductor test
according to ARTD-002.731.17...
¹ The protective conductor resistance must not exceed 0.2
Ohms.
¹ When performing service work on the power-on module,
(replacing the power-on module or replacing the power
cable), the equivalent leakage current must be measured
and recorded.
¹ Checks and settings that need to be performed under
X-ray radiation are identified by the radiation warning
symbolx . When performing adjustments labeled as
shown here, appropriate radiation protection measures
must be taken (see ARTD, Part 2).
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10Installation
2Installation
3-
Overview0
SIREMOBIL and monitor trolley0
Refer to the valid installation instructions of the two units when installing the SIREMOBIL
and the monitor trolley:
MODULARIS Uro Plus0
Also refer to the document SPL1-130.033.02.. when installing the MODULARIS Uro (table
with Litho opening).
SONOLINE0
SONOLINE does not require any special installation instructions
Simply unpack the unit according to the "Unpacking procedure" attached to the outside
and attach the accessories including the monitor.
Unpacking LITHOSTAR MODULARIS Vario0
Fig. 2:Head, complete
NOTICE
Do not pull on the focus phantom (bracket (4/Fig. 2 / p. 10)), risk of
damage!
¹ Do not use the phantom as a handle.
•Remove the packaging above the unit.
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Medical Solutions
Installation11
Fig. 3:Ramp 01
Fig. 4:Ramp 2
•Remove the transport safety screw (1/Fig.3/p.11) used to secure the unit and the
ramp (2/Fig.3/p.11).
•Remove all transport safety brackets (3/Fig.3/p.11).
•Slide the ramp (5/Fig.4/p.11) out of the transport pallet from the back to the front and
position it appropriately.
•Move the unit off the transport pallet and down the ramp.
•Appropriately dispose of the packaging according to the country-specific regulations.
•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.
•Secure the operating panel bracket with the screws.
•Connect the operating panel.
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12Installation
•Place the control panel in the mount.
Docking unit0
NOTE
NOTE
The docking mandrel is pre-installed on the Vario centrally in relation to the longitudinal
axis (1/Fig.5/p.13) 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 on the front C-arm unit extension (2/Fig.5/p.13) and
(Fig. 16 / p. 18).
This chapter first describes mechanical coupling for Vario in combination with SIREMOBIL Compact. The differences with regard to
the combination with SIREMOBIL ISO-C with a separate bridge are
subsequently illustrated.
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 (SPL1-130.890.01...).
For the sake of clarity regarding technical work on all components,
the coordinates are determined in this document in Fig.
(Fig.5/p.13) (Vario with shock wave focus, C-arm unit with iso-
center, patient table). Side designations left and right are always
used for Vario and C-arm unit from the viewpoint of the operator in
a forward direction.
NOTE
The following diagrams are not shown to scale and apply for Vario
with Siremobil Compact and Compact L. Pre-clarification by the local project management is required for any other C-arm unit. The
procedure is then the same.
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Medical Solutions
Installation13
Fig. 5:Docking unit
Fig. 6:Docking securing_4
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14Installation
Fig. 7:Docking securing_2
Fig. 8:Docking securing_3
•Prepare the Vario to the left of the C-arm on a level floor (fix C-arm)
•Set the C-arm vertically to approx. 1070 mm in the center ((3/Fig.5/p.13)_ Z direction)
•Remove the top part of the docking bridge.
•Unscrew the docking bridge (1/Fig.6/p.13) or detailed view (1/Fig.7/p.14) and pull
the docking bridge apart so that the complete adjustment range is available.
•Place the bottom part of the docking bridge on the C-arm extension, min. 140 mm in the
X direction (1/Fig.9/p.15) and approximately centered.
•The docking bridge can be positioned horizontally via Allen screws (2/Fig.7/p.14). If
the adjustment range is insufficient, the preinstalled Allen screws (1/2/3/Fig. 8 / p. 14)
can be replaced with the included longer screws.
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Medical Solutions
Installation15
•Tighten the eight fastening screws (1/Fig.6/p.13) and (Fig.7/p.14).
•Set the Vario docking mandrel in the horizontal position (1/Fig.5/p.13).
•Set the Vario arm to be horizontal (gel or therapy position)
•When the Vario moves in, the mandrel must move over the lower part of the sleeve -
check heights from the floor (2/Fig. 10 / p. 15). Adjusting screws for adjusting the height
of the mandrel, see (1/Fig. 10 / p. 15). Use a level for this adjustment.
Fig. 9:Docking unit 2
•Move Vario in with a distance of at least 90 mm (2/Fig.9/p.15).
•Align the lower part of the docking bridge to the mandrel in X direction (1/Fig.9/p.15).
•Secure the bottom part with the Allen screw (1/Fig. 11 / p. 16).
•Position the top part of the docking bridge and secure it (1/Fig. 12 / p. 16).
•Test the inward movement and locking of the Vario. The latch must lock securely. Cor-
rection is performed using the black Allen screw in the latch (2/Fig. 12 / p. 16).
Fig. 10: View 1
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16Installation
Fig. 11: Lower part_
Fig. 12: Upper part
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Medical Solutions
Installation17
Fig. 13: Block
Fig. 14: Block_
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18Installation
Fig. 15: Block_mounted
Fig. 16: View 3
.
Combination with ARCADIS Orbic/SIREMOBIL0
The bridge is to be modified for ARCADIS Orbic and SIREMOBIL ISO-C according to
(Fig. 13 / p. 17).
•Remove both clamping screws (3/Fig.8/p.14).
•Screw the clamping screws from the enclosed material into the fastening block (1 und
2/Fig. 13 / p. 17).
•Attach these blocks to the bridge with 2 screws (3/Fig. 13 / p. 17).
•Position the bridge according to (Fig. 14 / p. 17).
•Horizontally position the bridge via the clamping screw (1/Fig. 14 / p. 17) (or see
(2/Fig.7/p.14) for more detail).
•Secure the bridge with the clamping screw (2/Fig. 14 / p. 17) and (1/Fig. 15 / p. 18).
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Medical Solutions
Installation19
•Position the top part of the docking bridge and secure it (1/Fig. 12 / p. 16).
•Test the inward movement and locking of the Vario. The latch must lock securely. Cor-
rection is performed using the black Allen screw in the latch (2/Fig. 12 / p. 16).
Unit association - labeling0
Label the supplied sticker with a permanent marker as shown in Figure: (Fig. 17 / p. 19).
All combinable C-arm units must be listed on the Vario. The combinable Vario must be
labeled on the C-arm unit. Attach label 1 (Figure (1/Fig. 17 / p. 19)) to the Vario (Figure:
(1/Fig. 18 / p. 20)). Attach label 2 (Figure: (Fig. 17 / p. 19)) to the C-arm unit in one of the
indicated areas (Figure: (2/Fig. 18 / p. 20)) so that no manufacturer information is covered. Cover both labels with a transparent film.
Fig. 17: Label 1
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20Installation
Fig. 18: Label 2
C-arm unit isocenter cross0
Fig. 19: Cross
Fig. 20: I.I. 1
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Medical Solutions
Installation21
Fig. 21: I.I. 2
Fig. 22: 3 cm I.I.
Attachment of the isocenter cross to the SIREMOBIL Compact and Compact L
•Remove the front screw on the I.I. and replace it with the M4 x 16 screw included in the
shipment (1/Fig. 22 / p. 21).
•The crosshairs must be position in the center of the mounting ring. Check this with a
tape measure and correct it if necessary.
•Snap the isocenter cross onto the I.I.
•Attach the arrows (Figure: (Fig. 20 / p. 20)) (indicating the centering stud).
•Place the supplied "serial number" labels on the isocenter cross (1/Fig. 22 / p. 21) and
the I.I. (2/Fig. 22 / p. 21).
External isocenter cross manufacturer0
Depending on the I.I. diameter, select one of the three delivered crosshairs and attach the
corresponding retaining brackets.
•Install the movable bracket (3/Fig. 22 / p. 21) in the crosshair extension.
•Install the two fixed brackets accordingly (4/Fig. 22 / p. 21).
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22Installation
•To allow for later adjustment, tighten the adjusting screw (5/Fig. 22 / p. 21) only loose-
ly. Use the center threaded hole first.
•Mount the grid and position it approximately in the middle.
•Attach the C-arm unit and the Litho module.
•Swing up the adjustment phantom on the shock wave head.
•Center the grid with the adjustment phantom under fluoroscopy by moving the retaining
brackets.
•Install the second screw in the retaining brackets and check again that the grid is cen-
tered.
•Adhere the arrows (6/Fig. 22 / p. 21) to the I.I.
Radiation release option0
NOTE
This option is performed according to the instructions SPR2-130.814.05... "Installation
Instructions for LITHOSTAR Modularis Vario". A paper version of this document is part of
conversion kit number 71 40 952.
The radiation release option of the Lithostar operating panel is released only for Siremobil Compact and Compact L.
MODULARIS Uro Table0
Installing the positioning yoke
•The positioning yoke is packed separately in the shipment (part no. 81 25 333).
•Attach the yoke to the table with the two screws as shown in ((1/Fig. 23 / p. 23)).
•The positioning yoke must be adjusted so that its height corresponds to that of the dock-
ing bridge ((1/Fig. 24 / p. 23)). Adjustment can be performed by turning the two rubber
stoppers ((2/Fig. 24 / p. 23)).
•The rubber stoppers must be secured by the screw ((1/Fig. 25 / p. 24)).
•No mechanical connection is created when operating the system for therapeutic pur-
poses. The C-arm is simply docked in the yoke.
•The yoke must be collapsed to the table base and rest completely on it when in the ta-
ble park position.
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Medical Solutions
Installation23
Fig. 23: Positioning_yoke_1
Fig. 24: Positioning_yoke_2
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24Installation
Fig. 25: Securing screw
Fig. 26: Positioning yoke
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Installation25
ECG triggering option0
Mounting the docking station
•Unscrew the rectangular plate (Fig. 27 / p. 26) from the docking station of the ECG
monitor. It is no longer required.
•Screw the docking station bracket from the conversion kit onto the round plate so that
the longitudinal grooves are visible from below (Fig. 28 / p. 26).
•Remove the round cap from the column of the system trolley. It is no longer required.
•Remove the cover from the system trolley.
•Disconnect the cables from the mount (7/Fig. 30 / p. 27).
•Plug the inlet connector for a non-heating apparatus (power cable) into the connector
strip (6/Fig. 30 / p. 27).
•Push the trigger cable from the D3.X70 board (beside the service switch) starting with
the jack plug, from beneath, through the column and lead it out, parallel to the wires, together with the power cable.
•Plug the inlet connector for a non-heating apparatus into the power supply unit of the
ECG monitor.
•Attach the power supply unit of the ECG monitor in the system cart to the support
(8/Fig. 30 / p. 27) via cable clamps.
•Push the 24 V cable of the power unit through the column from below and route it in the
same way as the trigger cable.
•Using a cable clamp for each from the conversion kit, secure both cables to the mount-
ing plate so that a length of approximately 35 cm is available outside the column.
•Screw the plate firmly onto the column so that the cables emerge from the corrugated
hose opposite each other, as shown in (Fig. 29 / p. 27).
•Connect the service PC.
•Select the ECG function according to the service instructions.
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26Installation
Fig. 27: Attachment 1
Fig. 28: Attachment 2
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Installation27
Fig. 29: Attachment 3
Fig. 30: Attachment 4
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