MODULARIS Installation and Start Up

MODULARIS Variostar

Installation and Startup System MODULARIS Variostar

Answers for life.

2

Document Version / Disclaimer / Copyright 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

MODULARIS Variostar

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Page 2 of 92 CS SD SP/CO

© Siemens, 2006 Restricted

Table of Contents

1

General information 1.1 1.2

1.3 1.4 1.5 1.6

2

3

3

5

Notes and symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2.1 Gen Genera rall safety inform rma ation (in exist stiing documents) . . . . . . . . . . 1.2.2 Ge General electrical safety information . . . . . . . . . . . . . . . . . . . . . . 1.2.3 Radiation safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Important Notes Regarding Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3.1 Applicability an and re regulations fo for re regional co companies. . . . . . . . . . Overview of MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.4.1 MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 7 7 7 8 9 9 10 10

Required technical documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Required Tools and Test Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.6.1 Required material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12 13 13

Installation

14

2.1

14 14 14 14 14 14 16 22 24 25 27 28 28 28 31

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.1 SI SIREMOBIL and monitor trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.2 ARCADIS Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.3 MO MODULARIS Uro Plus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.4 SONOLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.5 Un Unpacking MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.6 Docking unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.7 Connection, e.g. to ARCADIS Orbic / ISO C . . . . . . . . . . . . . . . . . . 2.1.8 Unit association - labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.9 C-arm unit isocenter cross . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.10 Ins Installing the isocenter cross on the C-Arm. . . . . . . . . . . . . . . . . . 2.1.11 E xt xternal isocenter cross manufacturer . . . . . . . . . . . . . . . . . . . . . 2.1.12 Ra Radiation release option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.13 MO MODULARIS Uro Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.1.14 ECG triggering option (VARIOSTAR 101 42 974) . . . . . . . . . . . . .

Startup


35

3.1

Operating elements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1.1 Location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1.2 In Individual keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.1.3 Membrane keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

35 35 36 37

3.2 3.3

C-arm unit and monitor trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.1 Ch C hecking the Line Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.2 Filling the cooling circuit and coupling circuit . . . . . . . . . . . . . . . 3.3.3 Co C onnecting modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.4 Co C onnecting the X-ray C-arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.3.5 Co Connecting MODULARIS Variostar . . . . . . . . . . . . . . . . . . . . . . . . 3.3.6 Checking/correcting the focus position . . . . . . . . . . . . . . . . . . . . . 3.3.7 Ch C hecking the isocenter with X-ray . . . . . . . . . . . . . . . . . . . . . . . . 3.3.8 Shockwave release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39 40 40 41 42 44 48 54 61 61

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Table of Contents

3.4 3.5

3.6 3.7

4

61 62 63 63 64 73 74

MUT MODULARIS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Final Work Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

83 84

Retrofitting MODULARIS Uro (old table) 4.1

5

3.3.9 Triggering shock waves with ECG (optional) . . . . . . . . . . . . . . . . MODULARIS Uro (table). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ultrasound localization (101 42 909), optional . . . . . . . . . . . . . . . . . . . . . . 3.5.1 SONOLINE G20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5.2 Ultrasound localization retrofit . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.5.3 Selecting the MODULARIS cross on the SONOLINE G20 . . . . . . . . 3.5.4 Isocenter with ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

85

Retrofitting MODULARIS Uro (old table) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.1 Scope of the retrofit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1.2 Replacing the electronics box . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Final Work Steps

85 85 85

87

5.1

Customer and country-specific settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1.1 Setting the system clock (if necessary) . . . . . . . . . . . . . . . . . . . . .

87 87

5.2 5.3

Backup and error memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Remaining work . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

88 89

6

Changes to previous version

90

7

List of Hazard IDs

91

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General information 1

1.1 Notes and symbols Emphasized text in this technical documentation has the following meanings: Tab. 1 GEFAHR / DANGER

Bei einer unmittelbar drohenden Gefahr, die bei Nichtvermeidung zum Tod oder zu einer schweren Körperverletzung führt.

Indicates when there is an immediate danger that leads to death or serious physical injury.

Tab. 2 WARNUNG / WARNING

Bei einer Gefahr, die bei Nichtvermeidung zum Tod oder zu einer schweren Körperverletzung führen kann.

Indicates a risk of danger that may lead to death or serious physi‐ cal injury.

Tab. 3 VORSICHT / CAUTION

Bei einer Gefahr, die bei Nichtvermeidung zu einer leichten oder mittleren Körperverletzung und/ oder zu einer Sachbeschädigung führt oder führen kann. Indicates a risk of danger that leads to slight or moderate physical injury and/or damage to property.

Tab. 4 ACHTUNG / NOTICE

Bei einer Gefahr, die bei Nichtvermeidung zu einem uner‐ wünschten Ergebnis oder Zustand führt oder führen kann ( nicht Tod, Körperverletzung oder Sachbeschädigung). Indicates a risk of danger that if disregarded leads or may lead to a potential situation which may result in an undesirable result or state (not death, physical injury or property damage).


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6

1 General information Tab. 5

HINWEIS / NOTE

Ist als Tipp zu verstehen. Der Anwender muss diese Anweisung nicht unbedingt beachten. Er erfährt jedoch Vorteile, wenn er dies tut. Should be understood as a tip. The user does not absolutely have to observe these instructions. However, there will be advantages if he does.

MODULARIS Variostar

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1.2 Safety information 1.2.1

General safety information (in existing documents) 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.

1.2.2

General electrical safety information 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.


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MODULARIS Variostar

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8

1 General information 1.2.3

Radiation safety information 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.

X

Please note: 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.

MODULARIS Variostar

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1.3 Important Notes Regarding Startup The device was installed, programmed, and tested at the factory (refer to the test certifi‐ cate 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.

p must be entered in the

All measurement results from measurements labeled with test certificate listed in each instance.

 1.3.1

These measurement values as well as the values determined during start-up can be cop‐ ied from the test certificate to the acceptance certificate.

Applicability and regulations for regional companies Equivalent leakage current measurement The equivalent leakage current must be measured where applicable under the require‐ ments of DIN VDE 0751 Part 1. Where DIN VDE 0751 does not apply, the regional companies should comply with the f ol‐ lowing 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 ad‐ hered to in the interest of the safety of customers, patients, employees and third parties as well as the company.

First 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 the service engineer should sign and date this copy). 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 determined from the repeat measurements must not exceed the threshold value of 1 mA as specified in VDE 0751, Part 1. In addition, they must not exceed the initial measured value by more than 50 %. If the value exceeds this threshold, the system must be re‐ paired. The measured value must be documented.


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MODULARIS Variostar

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10

1 General information

1.4 Overview of MODULARIS Variostar 1.4.1

MODULARIS Variostar Fig. 1: Variostar

MODULARIS Variostar

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General information 1 Fig. 2: Overview of complete system


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MODULARIS Variostar

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12

1 General information

1.5 Required technical documents n

Start-up, release for operation

SPL1-130.815.20..

n

*PG Variostar

SPL1-130.891.20..

n

Troubleshooting Instructions for MODULARIS Variostar SPL1-130.840.20..

n

**LITHOSTAR MODULARIS Variostar adaptation

SPR2-130.814.05..

n

MODULARIS Uro Plus operating instructions

SPL1-130.620.01..

n

MODULARIS Variostar operating instructions

SPL1-130.620.20..

n

C-arm unit operating instructions

n.a.

n

MODULARIS Uro Service Instructions

SPL1-130.061.02..

* Only in combination with a non-Siemens C-arm unit. **Only in combination with Siemens C-arm units.

MODULARIS Variostar

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1.6 Required Tools and Test Equipment n

Standard installation tools

n

Service PC, refer to intranet, service laptop for CSEs

n

PC connection cable, 5 m

99 00 440 RE999

n

Internal line resistance meter

84 28,104 RE999

n

ESD equipment

n

Protective conductor testing device

44 15 899 RV090

n

DVM, e.g.. Fluke 187

99 94 831

n

Bender safety meter

97 06 979 Y0526

n

1.6.1

Spray can or varnish applicator of the color white grained 99 00 705 RE999 MED surface no. 4146 similar to RAL grayish white 9002.

Required material n


Approx. 10 liters of sterile water

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2 Installation

2.1 Overview 2.1.1

SIREMOBIL and monitor trolley Refer to the valid installation instructions of the two units when installing the SIREMOBIL and the monitor trolley:

2.1.2

ARCADIS Systems Refer to the valid installation instructions when installing the ARCADIS system.

2.1.3

MODULARIS Uro Plus Also refer to the document SPL1-130.033.02... when installing the MODULARIS Uro (table with Litho opening).

2.1.4

SONOLINE 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.

2.1.5

Unpacking MODULARIS Variostar Fig. 3: Head with focus phantom

MODULARIS Variostar

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Installation 2

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

Remove the packaging above the unit.

Fig. 4: Transport pallet

n

n

Disconnect the yellow transport safety bracket (  1/Fig. 4 Page 15) that secures the device from both sides. 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

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. Connect the control panel.

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MODULARIS Variostar

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16

2 Installation 2.1.6





Docking unit 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.

MODULARIS Variostar

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Installation 2 Fig. 5: Docking unit

Fig. 6: Docking securing_4


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MODULARIS Variostar

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18

2 Installation Fig. 7: Docking securing_2

Fig. 8: Docking securing_3

n

n

n

n

n

Prepare the Variostar 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 Page 17)_ Z di‐ rection) Remove the top part of the docking bridge. 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. 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).

MODULARIS Variostar

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Installation 2 n

The docking bridge can be positioned horizontally via Allen screws ( 2/Fig. 7 Page 18). If the adjustment range is insufficient, the preinstalled Allen screws ( 1/2/3/Fig. 8 Page 18) can be replaced with the included longer screws.

n

Tighten the eight fastening screws (  1/Fig. 6 Page 17) and (  Fig. 7 Page 18).

n

Set the Variostar docking mandrel in the horizontal position (  1/Fig. 5 Page 17).

n

n

Move the shock wave head to the UT (undertable) therapy position. When the Variostar moves in, the mandrel must move over the lower part of the sleeve - check heights from the floor (  2/Fig. 10 Page 20). Clamping screws for ad‐ justing the height of the mandrel, see ( 1/Fig. 10 Page 20). Use a level for this ad‐ justment.

Fig. 9: Docking unit 2

n

n

Move Variostar in, to a distance of approx. 20 mm (  2/Fig. 9 Page 19). Align the lower part of the docking bridge to the mandrel in X direction ( 1/Fig. 9 Page 19).

n

Secure the bottom part with the Allen screw (  1/Fig. 11 Page 20).

n

Position the top part of the docking bridge and secure it (  1/Fig. 12 Page 21).

n

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). Finally, perform a rough visual inspection to check whether the central ray (X-ray) can pass through the focus of the shock wave head.

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MODULARIS Variostar

19

20

2 Installation Fig. 10: Variostar connection

Fig. 11: Lower part_

MODULARIS Variostar

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Installation 2 Fig. 12: Upper part

Fig. 13: Block


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MODULARIS Variostar

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22

2 Installation Fig. 14: Docking bridge

Fig. 15: Block_mounted

.

2.1.7



Connection, e.g. to ARCADIS Orbic / ISO C 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.

MODULARIS Variostar

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Installation 2 For ARCADIS Orbic / ISO C, the docking bridge has to be adapted accordingly ( Fig. 13 Page 21). n

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

n

2.1.7.1



Screw the clamping screws from the enclosed material into the fastening block ( 1 und 2/Fig. 13 Page 21).

n

n



Remove both clamping screws (  3/Fig. 8 Page 18).

Horizontally position the docking bridge with the adjustment screw ( 1/Fig. 14 Page 22) (or see (  2/Fig. 7 Page 18) for more detail). Position the top part of the docking bridge and secure it (  1/Fig. 12 Page 21). 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."

Collision warning labels 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.

Fig. 16: Warning labels 1


Fig. 17: Warning labels 2

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Unit association - labeling Label the supplied stickers with a permanent marker as shown in Figure: ( Fig. 18 Page 24). All combinable C-arm units must be listed on the Variostar. The combinable Variostar must be labeled on the C-arm unit. Affix Label 1 (Figure: ( 1/Fig. 18 Page 24)) to the Variostar (Figure: ( 1/Fig. 19 Page 25)). Affix Label 2 (Figure: ( Fig. 19 Page 25)) to the C-arm unit at one of the indicated areas (Figure: ( 2/Fig. 19 Page 25)) in such a way that no manufacturer's information is covered up. Cover both labels with adhesive transparent film (included in delivery). Fig. 18: Label__1

(1) (2) (3) (4) (5)

MODULARIS Variostar

Variostar_serial_number Manufacturer and type, C-arm unit C-arm_unit_serial_number C-arm_unit_serial_number Variostar_serial_number

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Installation 2 Fig. 19: Label 2

2.1.9

C-arm unit isocenter cross Fig. 20: Cross

Fig. 21: I.I. 1


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26

2 Installation Fig. 22: I.I. 2

Fig. 23: Image_intensifier_Universal_crosshairs

Installing the isocenter cross on the SIREMOBIL Compact n

n

Remove the front screw on the I.I. and replace it with the M4 x 16 screw included in the shipment ( 1/Fig. 23 Page 26). The crosshairs must be positioned in the center of the mounting ring. Check this with a tape measure and correct it if necessary.

n

Snap the isocenter cross onto the I.I.

n

Affix the arrows (Figure: ( Fig. 21 Page 25)). Note the centering bolts.

n

n

Place the supplied "serial number" labels on the isocenter cross (  1/Fig. 23 Page 26) and the I.I. ( 2/Fig. 23 Page 26). Replace the I.I ring if necessary; see following instructions.

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Installation 2 2.1.10

Installing the isocenter cross on the C-Arm

Fig. 24: Installation, isocenter cross_01



2.1.10.1

Installing the grid ring In order to be able to attach the centering cross, it is necessary to replace the existing grid ring. n

n

n

n


Remove grid ( 1/Fig. 24 Page 27) and grid ring (  2/Fig. 24 Page 27) after removing the attachment screws (  3/Fig. 24 Page 27). Mount the grid in the new grid ring. Note the position of the grid's plastic covers ( 1/Fig. 26 Page 27). Use the existing fasteners (  2/Fig. 26 Page 27) to secure the grid. With the Modularis, the switch located in the gr id ring need not be connected. Set the grid ring on the I.I. and secure it using the screws (  1/Fig. 25 Page 27) inclu‐ ded with delivery.

SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

27

28


External isocenter cross manufacturer Depending on the I.I. diameter, select one of the three delivered crosshairs and attach the corresponding retaining brackets.

2.1.12



n

Install the movable bracket (  3/Fig. 23 Page 26) in the crosshair extension.

n

Install the two fixed brackets accordingly (  4/Fig. 23 Page 26).

n

Set the crosshair unit in place and center it using a ruler.

n

Tighten the adjustment screws (  5/Fig. 23 Page 26).

n

Attach the C-arm unit and the Litho module.

n

Swing up the focus phantom on the shock wave head.

n

Affix the arrows ( 6/Fig. 23 Page 26) to the I.I.

Radiation release option The radiation release option of the Variostar operating panel is released only for Siremo‐ bil Compact L and ARCADIS Varic / Orbic. This option is performed according to the instructions SPR2-130.814.05... "Installation In‐ structions for LITHOSTAR Modularis Variostar". A paper version of this document is part of conversion kit number 71 40 952 .

2.1.13 2.1.13.1

MODULARIS Uro Table Installing the positioning yoke n

n

n

n

n

n

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. 27 Page 29)). The attachment blocks must be selected according to the height of the docking bridge. The positioning yoke must be adjusted so that its height corresponds to that of the docking bridge (( 1/Fig. 28 Page 29)). Adjustment can be performed by turning the two rubber stoppers (( 2/Fig. 28 Page 29)). The rubber stoppers must be secured by the screw (( 1/Fig. 29 Page 30)). No mechanical connection is created when operating the system for therapeutic pur‐ poses. The C-arm is simply docked in the yoke. In the table park position, the yoke must be collapsed to the table base.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Installation 2 Fig. 27: Positioning_yoke_1

Fig. 28: Positioning_yoke_2


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MODULARIS Variostar

29

30

2 Installation Fig. 29: Securing screw

Fig. 30: Positioning yoke

MODULARIS Variostar

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Installation 2 2.1.14 2.1.14.1

ECG triggering option (VARIOSTAR 101 42 974) Mounting the docking station n

n

n

n

n

Unscrew the rectangular plate (  1/Fig. 31 Page 31) from the docking station of the ECG monitor. It is no longer required. The screws will be used to secure the support arm. Unscrew the two covers. Remove the cover from the system trolley. Attach the power supply unit and the power supply cable of the ECG monitor in the system trolley to the support, using cable ties. Insert the non-heating apparatus plug in the power supply ( Fig. 34 Page 32). 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 pull wire if necessary).

n

Route both cables so that a length of approx. 35 cm is available outside the column.

n

Screw the plate firmly onto the column so that the cables emerge - as shown in .

Fig. 31: Docking station ECG 1


SPL1-130.814.20.03.02 02.08

Fig. 32: Cable routing


MODULARIS Variostar

31

32

2 Installation Fig. 33: ECG monitor installation 1

Fig. 34: Installing the ECG power supply

ECG Infinity Gamma set, part no.: 1158158 n

n

Install the ECG monitor (including the interface card) and the mounting plate, in ac‐ cordance with the ECG monitor instructions included with delivery. Push the monitor into the holder, as shown in the illustration: (  Fig. 33 Page 32).

Optional external ECG monitor (10142927) n

Set up the monitor in the location desired by the customer.

n

Connect the power supply.

n

n

Connect the ECG signal cable at the rear of the monitor. Connect the other end of the ECG signal cable to the ECG monitor; see: ( 1/Fig. 33 Page 32).

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Installation 2 Fig. 35: ECG monitor installation 2

n

The “Monitor setup menu” is described in the monitor instructions.

n

Select "Auto adjustment".

n



Compare the ECG monitor input signal to the signal information at the external ECG monitor.

Activate ECG triggering.


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MODULARIS Variostar

33

34

2 Installation 7. Service tab card: System setup Handheld remote control displays

Fig. 36: System setup

Display item

Description

ECG triggering Enable/disable ECG triggering for option shock wave release.

Fmax

Maximum shock frequency, for ex‐ ample: US = 120 Europe = 240

Start potenti‐ ometer cali‐ bration (but‐ ton)

Starts the calibration procedure for the "US probe holder" potentiome‐ ter.

Potentiometer Possible statuses: calibration - Not calibrated - calibrated Procedure: refer to chapter on US calibration. Potentiometer Shows the potentiometer calibra‐ calibration val‐ tion value in mV. ue 1: see ( 1/Fig. 36 Page 34)

Delete the "patient ID" in the Vario‐ star.

2: see ( 2/Fig. 36 Page 34)

SW update Insert the SP card with the new soft‐ ware. Select the "disk" symbol and follow the instructions.

3: see ( 3/Fig. 36 Page 34)

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08

Select the language. English, German, French, or Span‐ ish



Startup 3

3.1 Operating elements The hand-held remote control is divided into three areas: Fig. 37: Hand-held remote control

(1) Display for menu guidance (2) Individual keys for menu control of radiation and shock wave release (3) Membrane keys for setting the therapy parameters and controlling the patient table and X-ray C-arm

3.1.1

Location Menu guidance in the display is implemented with tab cards whose arrangement and content are based on the typical procedure o f urological treatment.


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

35

36

3 Startup Fig. 38: Display

(1) (2) (3) (4)

3.1.2

Info line: display of shock wave parameters Tab card tabs Display of the set parameters or setting of different parameters Dynamic menu function: refer to individual keys, reset, patient position

Individual keys The keys under the display are for releasing radiation and shock waves as well as for se‐ lecting menus in the display.

MODULARIS Variostar

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Startup 3 Fig. 39: Individual keys

(1) (2) (3) (4) (5)

Dynamic menu key; current key assignment is shown on the display Menu navigation keys (up/down arrow keys) and parameter input keys (left, right arrow keys) Confirmation key for executing the selected menu entry Key for releasing shock waves 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)

3.1.3

Membrane keys Pre-programmed functions for stone localization and treatment are assigned to mem‐ brane keys.


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

37

38

3 Startup Fig. 40: Membrane keys

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13)

MODULARIS Variostar

Increase coupling pressure Decrease coupling pressure Increase the shock wave energy Decrease the shock wave energy Raise the patient table Move the patient table in direction: (a) head-end, (b) left patient side, (c) foot-end, (d) right patient side Note: The patient position must be selected correctly Move the patient table to the basic ESWL position Lower the patient table Increase the shock wave frequency Decrease the shock wave frequency Storage of the currently displayed fluoroscopic image (Last Image Hold) Change the patient position. "Patient in right head position" or "Patient in left head position" Angulate the X-ray C-arm ± 20°

SPL1-130.814.20.03.02 02.08



Startup 3

3.2 C-arm unit and monitor trolley

P

Use the documentation of the system type for the start-up. If it is a "non-Siemens system", the following points must be fulfilled: n

n

Perfect functioning must have already been ensured by the responsible start-up engi‐ neer. The release from the planning guide must be available from Siemens project manage‐ ment. Implementation of the combination by the documentation with the dimension protocol from planning guide SPL1-130.891.01...

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.


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MODULARIS Variostar

39

40

3 Startup

3.3 MODULARIS Variostar 3.3.1

P

Checking the Line Voltage n

n

Measure the line voltage at the power outlet. Compare the measured line voltage to the value in the test protocol. The voltage can be changed. The jumpers are located on the transformer in the MODULARIS Variostar.

Fig. 41: Air bleeder valve

Fig. 42: Cooling unit

MODULARIS Variostar

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Startup 3 3.3.2

Filling the cooling circuit and coupling circuit n

n

n

n

Remove the front cover from the system trolley and then open the right cover panel door (magnetic holder). The cooling unit can be pulled partially out of the trolley for better access, after the 4 hex screws on the side have been removed. (wrench size 10). Check the bleeder valve at the back, and if closed, open (cap) in the cooling unit with one turn ( 1/Fig. 41 Page 40) (the valve must remain open at all times). Open the Velcro strap, remove the water reservoir tank, and fill it with approximately 10 liters of clean water.

n

Reinstall the water reservoir tank.

n

Set service switch S2 on board D3 to position 1 (normal operation, service off).

n

Set the shockwave head (50 ˚) to the undertable position, see ( Fig. 43 Page 41).

n

Switch on the system.

n

n

n

n

The coupling circuit and cooling circuit are filled automatically in sequence (cooling circuit pump M1 runs the appropriate period of time, V188 on board D3 illuminates). Filling the unit without creating bubbles takes approximately 5 minutes. During filling, check the coupling bellows for bubbles. If necessary, remove the bubbles by pressing on the coupling bellows. If necessary, start the rinsing cycle again. Once the system is filled completely, check the fill level of the water reservoir. If it is not filled to the 10 liter mark, add water until it is. Finally, check the system for any leaks and reinstall the covers.

Fig. 43: Shock_wave_head_50_degree_undertable_position


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MODULARIS Variostar

41

42

3 Startup 3.3.3 3.3.3.1



Connecting modules Setting up the patient table Adhere to the MODULARIS Uro operator manual and the safety information contained therein (Safety register).

Positioning the patient table n

Move the patient table to the desired position in the treatment room.

n

Lock all brakes.

n

Connect the patient table to the line voltage and switch it on.

-

The MODULARIS Uro patient table and its hand-held remote control are ready for operation.

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.

MODULARIS Uro hand-held remote control:

MODULARIS Variostar

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Startup 3 Fig. 44: MODULARIS Uro hand-held remote con‐ trol

(1)

Moves the patient table longitudinal‐ 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 (6)

basic position Select/deselect lithotripsy (when selected, the corresponding LED illu‐ minates)

Coupling position Fig. 45: Coupling position

n

Move the patient table sideways, away from the table cutout.

n


The C-arm can be moved in more easily in this position.

Remove the table cutout.

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MODULARIS Variostar

43

44

3 Startup n

3.3.4

Fold the adjusting device forward.

Connecting the X-ray C-arm The docking tunnel for connecting the MODULARIS Variostar must be installed on the cross-arm base of the X-ray C-arm according to the installation instructions.

 3.3.4.1

Observe the instructions in the operator manual of the X-ray C-arm and the safety infor‐ mation contained therein.

Installing the crosshair disk Depending on the X-ray C-arm system being used, different crosshair disks for the image intensifier are used.

CAUTION The crosshair disk could fall. Risk of injury! After assembly, ensure that it is secure.

Siemens C-arm (7" and 9" I.I.s) For Siemens X-ray C-arm systems, the appropriate crosshair disks for the specific C-arm type must be used.



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.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 Fig. 46: Crosshair disk

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.

n

The spring clips of the crosshair disk must snap audibly into the recess in the image intensifier when pressed.

Ensure that the crosshair disk is securely in place.

Third party C-arm For X-ray C-arm systems from third-party manufacturers, the universal crosshair disk must be used. Fig. 47: Flexible mounting

(1) Rigid fastening hooks (2) Flexible spring clip with triangular marker n

n

n

n


Align the triangular marker on the spring clip of the crosshair disk with the one on the image intensifier. Attach the crosshair disk to the image intensifier with the rigid hooks. 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. Ensure that the crosshair disk is securely in place.

SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

45

46

3 Startup 3.3.4.2

Preparing the X-ray C-arm The X-ray C-arm is moved to the patient table and started up but is not yet connected. n

Move the X-ray C-arm to the patient table.

n

Position it at approx. 90˚ with respect to the longitudinal axis of the patient table.

Lock the foot brakes of the X-ray C-arm.

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.

Positioning the C-arm Fig. 48: Positioning the C-arm

n

Move the swivel, angulation, and orbital position of the X-ray C-arm to the 0˚ posi‐ tion. Lock the brakes again.

n

When using SIREMOBIL Iso-C, SIREMOBIL Iso-C 3D, or ARCADIS Orbic/3D, the triangu‐ lar marker of the C-arm guide must match the triangular marker on the C-arm ex‐ actly.

Move fully in the horizontal travel direction and lock the brake.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 3.3.4.3

Connecting the X-ray C-arm

CAUTION Insufficient alignment of the C-arm or coupling of a C-arm with an insufficient Cshape (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.

Fig. 49: Coupling the C-arm

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.


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

47

48

3 Startup Fig. 50: Coupling tunnel

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

3.3.5

Lock the brakes on the X-ray C-arm.

Connecting MODULARIS Variostar Adhere to the detailed description of the subsequently used device functions in ESWL Therapy Unit.

3.3.5.1

Preparing MODULARIS Variostar

MODULARIS Variostar

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Startup 3 Fig. 51: Preparing Variostar

n

n

3.3.5.2

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. Check for correct locking in the end positions.

Coupling MODULARIS Variostar n

Move the tabletop away from the C-arm and then to the lowest patient entry position.

-

This prevents damage to the coupling bellows during the coupling procedure.

Fig. 52: Locking lever

n


Open the locking lever of the docking tunnel on the X-ray C-arm by turning it counter‐ clockwise.

SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

49

50

3 Startup Fig. 53: Folding out the coupling arm

n

n

Open the transparent doors on the front side of the MODULARIS Variostar and fold out the coupling arm by lifting the lock. Close the transparent doors.

Fig. 54: Locking in the coupling arm

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.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 Fig. 55: Locking

n

Close the locking lever of the docking tunnel by turning it clockwise.

n

This locks the coupling between the X-ray C-arm and MODULARIS Variostar.

Check the coupling by pulling on the MODULARIS Variostar.

-

The coupling arm must not move in the docking tunnel. The connection procedure may need to be repeated.

Fig. 56: Checks


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MODULARIS Variostar

51

52

3 Startup n

Lock the locking brake on the MODULARIS Variostar by stepping on the pedal.

3.3.5.3

Press the pedal until the end position is reached (locks in place). The feet of the device box extend.

Establishing the cable connections The cable connection between the coupled modules is necessary to allow shared control by the MODULARIS Variostar hand-held remote control.



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 Xray C-arm.

Patient table Fig. 57: Cable connection 1

n

n

Coil the cable with the plug marked in gray in the cable compartment of the MODULA‐ RIS Variostar. Run the cable through the cable gap and out of the cable compartment.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 Fig. 58: Cable connection 2

n

Plug the cable into the base of the patient table.

-

During lithotripsy operation, this connection allows table movement via the handheld remote control of the MODULARIS Variostar.

Siemens C-arm Fig. 59: Cable connection 3


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

53

54

3 Startup n

n

Run the cable with the plug marked in yellow through the cable gap and out of the cable compartment of the MODULARIS Variostar. Connect the cable to the front of the Siemens X-ray C-arm.

n

3.3.5.4

This connection facilitates the generation and storage of X-ray images via the MOD‐ ULARIS Variostar handheld remote control.

Additionally, for ARCADIS Varic and SIREMOBIL Compact L, connect the cable marked in blue for the C-arm angulation motor drive (if present).

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

Switch on the MODULARIS Variostar and the other components. - The coupled modules are now ready for operation.

3.3.6

Checking/correcting the focus position The connected modules, X-ray C-arm, and MODULARIS Variostar must be adjusted with respect to one another. For this purpose, the X-ray central beam must run in the 0˚ and oblique projection of the X-ray C-arm through the focus phantom.

Display on the monitor The metal ball located in the focus phantom is displayed as a dark circle on the live moni‐ tor. The correct focus position is assessed with respect to its position relative to the cross‐ hair.

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 Fig. 60: Focus position

(1) Correct setting: circle is centered in crosshair (2) Tolerance range: circle touches the imaginary extension of the horizontal and vertical crosshair bars (3) Correction required

3.3.6.1

Preparing the focus phantom Fig. 61: Preparing the focus phantom

n

n

n

3.3.6.2

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. Press the two sliders on the side of the focus phantom in the direction of the arrow and fold the focus phantom bracket up. Allow the focus phantom bracket to snap audibly into place and ensure that it is se‐ cure.

Performing check/adjustment


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MODULARIS Variostar

55

56

3 Startup Fig. 62: Check adjustment 1

n

Make sure that the orbital movement of the X-ray C-arm is locked in the 0˚ position.

Fig. 63: Check adjustment 2

n


Move the X-ray C-arm at an angle to the 0˚ position (vertical position) and release fluoroscopy.

-

The focus phantom (1) and the crosshair appear on the fluoroscopic image.

X axis (horizontal swivel)

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08



Startup 3 Fig. 65: Check adjustment 4

n


Adjust the X axis of the system under fluoroscopic control by swiveling the X-ray C-arm about its vertical axis of rotation.

n

In the fluoroscopic image, the focus phantom (1) must lie on the X line of the crosshair or in its ex‐ tension.

Lock the horizontal swivel movement direction in this position.

Y axis (horizontal travel) Fig. 67: Check adjustment 6


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

57

58

3 Startup

n


Adjust the Y axis of the system under fluoroscopic control by moving the X-ray C-arm along the horizon‐ tal longitudinal axis of the unit.

n

In the fluoroscopic image, the focus phantom (1) must lie in the crosshairs.

Lock the horizontal travel direction in this position.

Z axis (vertical travel) Fig. 69: Check adjustment 7

n


Angulate the X-ray C-arm by at least 15˚ from its ver‐ tical position and release fluoroscopy.

-

MODULARIS Variostar

SPL1-130.814.20.03.02 02.08

In the event of an incorrect adjustment of the Z ax‐ is, the focus phantom (1) is shifted by the oblique projection along the Y line of the crosshair.



Startup 3 Fig. 71: Check adjustment 8

n


Adjust the Z axis of the system under fluoroscopic control by raising/lowering the X-ray C-arm along the horizontal vertical axis of the unit.

n

In the fluoroscopic image, the focus phantom (1) must lie in the crosshairs.

Lock the vertical travel direction in this position.

Completing the check/adjustment

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


SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

59

60

3 Startup Fig. 73: Check adjustment 10

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 Fig. 74: Check adjustment 11

n


MODULARIS Variostar

SPL1-130.814.20.03.02 02.08

Move the X-ray C-arm at an angle in‐ to the 0˚ position (vertical position).



Startup 3 3.3.7



3.3.8

Checking the isocenter with X-ray 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).

Shockwave release n

n

n

3.3.9

Pump water into the coupling bellows. Apply some coupling gel to the coupling bellows to protect them (the coupling gel will prevent the coupling bellows from being significantly damaged when shock waves are triggered without a patient). Increase the shock wave energy in steps from the lowest energy level to the highest energy level and release additional shock waves at every energy level.

Triggering shock waves with ECG (optional) n

Attach the ECG monitor to the docking station in accordance with the operating in‐ structions.

n

Connect the power and signal cables to the back of the ECG monitor.

n

Connect the ECG electrodes to a test subject or connect the ECG simulator to the the ECG device.

n

Select ECG triggering on the MODULARIS Variostar control panel.

n

Spread some coupling gel on the coupling bellows to protect it.

n


Increase the shock wave energy in steps from the lowest energy level to the highest energy level and release additional shock waves at every energy level.

SPL1-130.814.20.03.02 02.08


MODULARIS Variostar

61

62

3 Startup

3.4 MODULARIS Uro (table)



If the Uro table was not included in the delivery volume of the Variostar, the old table must be installed - for the second table position - in accordance with the following in‐ structions; refer to the chapter "Retrofitting MODULARIS Uro (o ld table)". The following documents are required to start up the MODULARIS Uro: Start up the table according to the instructions SPL1-130.814.05.01...

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

n

Connect the cables between the MODULARIS Variostar and MODULARIS Uro. 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.

MODULARIS Variostar

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Startup 3

3.5 Ultrasound localization (101 42 909), optional Fig. 76: SONOLINE G20

3.5.1

SONOLINE G20 n

n

n


Attach the connector adapter (  1/Fig. 76 Page 63) to the serial interface (RS 232) and secure the screws. Install software version V1.0.302 or higher in the SONOLINE G20 (see the SONOLINE G20 operating instructions, chapter 4). Enable ultrasound localization (refer to the Chapter "Ultrasound localization").

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64

3 Startup 3.5.2

Ultrasound localization retrofit

Fig. 77: Deinstalling the cover

Fig. 78: US case

Fig. 79: US installation plate

3.5.2.1

Routing the US interface cables With the US localization option, the interface cable for the US unit from the ultrasound localization kit (part no. 10142909) must also be inserted into the right-hand cable feedthrough. Free cable length, measured from the cable feed-through to the end of the plug

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Startup 3 n

Interface cable for the US unit (optional) 2850mm +5mm Route the US interface cable through the device box; see (  Fig. 80 Page 65) and ( Fig. 81 Page 65). Make sure the cable feed-throughs fit securely around the cables.

Fig. 80: Cable feed-through 1

Fig. 81: Cable feed-through 2

Connect the US interface cable according to the instructions on the label.


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66

3 Startup Fig. 82: Installing the shock wave head

n

n

n

n

n



Remove the two cover panels ( 1/Fig. 77 Page 64). Remove the two installation plates (  1/Fig. 78 Page 64) with the centering sleeves ( 2/Fig. 78 Page 64) from the US case. Insert 2 centering sleeves in each of the installation plates (  1/Fig. 79 Page 64). Then, attach the installation plates to the shock wave head with the screws provided ( 3/Fig. 82 Page 66). The screws( 2/Fig. 82 Page 66) must not becovered up!

The following section outlines the work steps for the old D3, serial number < 3000.

Fig. 83: Electronics unit D3 D4

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Startup 3 Fig. 84: Controller 2

n

Remove the controller cover ( 1/Fig. 83 Page 66).

n

The retaining pins are already mounted on the board (AS 03).

n



Plug the additional MUP D3 board from the conversion kit into position ( 1/Fig. 84 Page 67) and screw it in place.

Reattach the controller cover (  1/Fig. 83 Page 66).

The following section outlines the work steps for the US connection of the new D3 board (10142950), serial number 3000 and higher. After the US localization option is installed, no further configuration is necessary. When communication is taking place between the US unit and the Variostar, the "US" field in the tableside control unit is active.


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68

3 Startup Fig. 85: D3 board, new

Fig. 86: D3 connections

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Startup 3 Fig. 87: D3 connections_2


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3 Startup Fig. 88: D3_Layout

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Startup 3 3.5.2.2

Adhesive labels for ultrasound unit Fig. 89: Adhesive label

n

3.5.2.3

Adjustment and start-up n

n

X

Switch the system on. Connect the US probe holder, with the cable provided, to the connector on the Vario‐ star support arm, and slide forward to the end stop.

n

Set the S2 switch on the D3 board to "Service".

n

Adjust the potentiometer in the ultrasound mount. To do so, open Service > System Setup menu on the handheld remote control.

n

n

n

n

3.5.2.4

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).

Select the Calibrate menu and confirm with the OK key (center navigation key). After you follow the instructions on the tableside control unit field, the calibration is complete. Check the US isocenter as described in this document in the Start-up chapter.

LithoShare with several ultrasound units Perform for each ultrasound unit.


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72

3 Startup

SONOLINE G20 Fig. 90: SONOLINE G20

n

n

n

Screw the connector adapter (  1/Fig. 90 Page 72) to the serial interface. Install software version V1.0.302 or higher in the SONOLINE G20 (see the SONOLINE G20 operating instructions, chapter 4). Enable ultrasound localization (Chapter: “ Selecting the MODULARIS cross on the SO‐ NOLINE G20" in this document).

MODULARIS Variostar

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Startup 3 3.5.3 3.5.3.1

Selecting the MODULARIS cross on the SONOLINE G20 Ultrasound localization Fig. 91: G20 cross_01

n

For ultrasound localization, a mount for an ultrasound probe is installed on the shock wave head.

Only the following probes can be used: C5-2 Convex Array 3.5 MHz n

Press the "F6" key.

n

Select MUP with the track ball.

n

Press the

n

Enter the password.

n

Use the track ball to select "Litho Mode no X-ray".

n

Select "save" via the track ball.

n

Press the

n

n


key.

key.

Deselect the screensaver on the SONOLINE G20 (see the SONOLINE G20 operating instructions). A cross is displayed when a probe is selected.

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3 Startup 3.5.4 3.5.4.1

Isocenter with ultrasound Preparations Fig. 92: View of unit

Fig. 93: Applicator_1

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Startup 3



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

n

n

n

Install the mount (  1/Fig. 92 Page 74) (see also operating instructions). 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. Plug in the cable (  2/Fig. 92 Page 74) and connect the probe to the ultrasound unit. Establish the line connection (marked orange) between the MODULARIS Variostar and the ultrasound unit.

Checking the target on the SONOLINE G20 Fig. 94: Target_Test_1


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3 Startup Fig. 95: Target_Test_2



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. 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

n

n

n

Use the trackball to position the crosshairs on the upper cross, click the "Measure‐ ment" button and select the "Set" measurement marker. Press the "Measurement" key and select the "Set" measurement marker. 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.

MODULARIS Variostar

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Startup 3 Fig. 96: Phantom 2

Fig. 97: Water bubble

Checking image tilt



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.

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78

3 Startup

n

n

n

n

n

-

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.

Spread contact gel on the isocenter phantom. Secure the water bladder (  5/Fig. 92 Page 74) to the isocenter phantom with the holder ( 6/Fig. 92 Page 74). Apply coupling gel to the ultrasound probe. Using the "image field/zoom" knob, set the value to "50" (  Fig. 98 Page 78) - lower left in the ultrasound image. Move the probe forward ( 3/Fig. 92 Page 74) until the crosshair is approx. in the cen‐ ter of the SONOLINE G20 screen.

Fig. 98: Basic settings_

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Startup 3 Fig. 99: Ultrasound arm_

n

Press the Menu button; the menu appears.

n

Make the following basic settings at the ultrasound unit:

Value:

Adjust using:

German

5 ( Fig. 98 Page 78)

Set track ball to edge FV (white background), then actuate and

English

French

Spanish

Edge

Côté

Contorno

Dyn Rng

DR

Cam Din

set the "Select" value via the controller. 35 dB ( Fig. 98 Page 78)

Set track ball to DR DR (white background), then actuate and set the "Select" value via the controller.



Each activation of the "Set" key increases the value by +1. The "Select" controller allows the value to be changed in both directions. n

Set the slide controls all the way to the left.

n

Select Zoom.


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80

3 Startup

n

n

n

Button

Image reverse may not be selected.

The corresponding ultrasound probe is selected during switch-on. If there is a sec‐ ond ultrasound probe, select the probe with the key. 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).

Checking the distance: Height Fig. 100: Distance_height

n

n

n

n

n

But‐ ton

key twice ("+1" cross is not necessary for this measurement).

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. Button

key.

Use the track ball to move the "+2" cross along the longitudinal (vertical) axis to the center of the the target cross. Press the

MODULARIS Variostar

key.

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Startup 3

n

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... . Press the

key.

Checking the distance: lateral n

n

n

n

n

n

-

Press the

key twice ("+1" cross is not necessary for this measurement).

Using the track ball move the "+2" cross onto the center of the spherical echo. Press the

key.

Using the track ball move the cross into the center of the target cross. Button

key.

If the horizontal deviation is greater than ± 0.5 mm from the center: Make a note of the value of D2 (with mathematical sign): If the display of the ball appears to the left of the target cross, the correction value must have a negative sign (to the right it must have a plus sign). Adjustments are made with corrections.

Adjustment and correction -

Press the F6 key.

-

Use the track ball to select MUP.

-

Press the “Set”

-

Enter the password.

-

Select OK via the track ball.

-

Press the "Set" key.

-

Use the track ball to select the value during image inclination and increase it with the "Set" key.

key.

German:

Bildneigung Array

French:

Basculement d'image sondes conv.

English:

Image tilt array

Spanish:

Inclinar imagen transductor curvo


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3 Startup -

Set half the value of D2.

Example : D2 = -1.2 mm ⇒ Enter: -06. Example : D2 = +1.2 mm ⇒ Enter: +06. -

Press

Save Button.

-

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

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. Following the check, store the parts in the appropriate transport cases.

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Startup 3

3.6 MUT MODULARIS The endoscopy trolley will be started up by the corresponding supplier.


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84

3 Startup

3.7 Final Work Steps See the chapter (  Final Work Steps / Page 87).

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Retrofitting MODULARIS Uro (old table) 4

4.1 Retrofitting MODULARIS Uro (old table) The retrofit must be performed if a MODULARIS Variostar is to be used with an existing Modularis Uro table (serial number < 1358). In this case, a new table control, material number 5666099, must be installed.



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.

4.1.1

Scope of the retrofit Replacing the electronics box (  1/Fig. 101 Page 86)

NOTICE

V

Electrical voltage! Disconnect the MODULARIS Uro from line voltage prior to working on the ta‐ ble.

4.1.2

Replacing the electronics box NOTICE Risk of injury! 2 people are required to turn over the table.

n

Use a wooden block or cloth to prevent the table from scratching.

n

Remove the table extensions.

n

Remove the cover.

n

If possible, move the table into Litho position and transversely, so that the accessory rail will be on the floor when the table is turned over.

n

Turn the table over.

n

Disconnect the cable connector from the electronics box.

n

Remove the electronics box (  1/Fig. 101 Page 86).

n

Install the new electronics box.

n

Connect the cable connector to the new electronics box (  2/Fig. 101 Page 86).

n

Reinstall all covers.


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4 Retrofitting MODULARIS Uro (old table) Fig. 101: Electronics box

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Final Work Steps 5

5.1 Customer and country-specific settings 5.1.1

Setting the system clock (if necessary) n

Switch MODULARIS Variostar ON.

n

Set the service switch in M13/D3/S2 to position 2 (service on).

n

Select "service" on the control panel and then "set clock".

n

Select the corresponding item and change the setting.

n

Set the service switch in M13/D3/S2 to position 1 (service off).


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88

5 Final Work Steps

5.2 Backup and error memory n

n

When the start-up is complete, perform a backup and then erase the error memory (e:show error log) (see Service Instructions). Delete the therapy data (t:show therapy data).

MODULARIS Variostar

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Final Work Steps 5

5.3 Remaining work n

Connect and secure the protective conductors to all the covers.

n

Measure the protective conductor resistance.

Measurement device:

Ground wire meter

Measured value: max. 0.2 ohms

(Ensure compliance with country-specific regulations.) (Current 10 A, voltage drop max. 2 V)

Measurement procedure:

Measure between all conductive parts of the system that can be touched and the ground wire bus rail in the generator.

Conditions:

Ground wire resistance max. 0.2 Ohm

n

n

Reduce the contact resistance (e.g. tighten the screws)

n

If necessary, increase the diameter of the protective conductor.

Cleaning the MODULARIS Variostar: For information on cleaning the system, refer to the chapter on "Cleaning/Disinfect‐ ing" in the operating instructions.

n

n

The manufacturer of this product requires information and the legislature demands proofs that a product delivered free of defects from the factory continues to possess the required and certified quality properties on installation and start-up. It is therefore absolutely necessary that the installation report with the installation and start-up data is sent without delay after completion of the work to the address stated on the instal‐ lation report. The report is available in the system binder. File the fax for the release for operation in the system binder. If the C-arm unit is not from Siemens, include the dimension protocol from the PG.

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).


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90

6 Changes to previous version

New warning label, chapter "Installation" New D3 in chapter "Startup"

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List of Hazard IDs 7 There are no Hazard IDs in this document.


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MODULARIS Installation and Start Up

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