The reproduction, transmission or use
of this document or its contents is not
permitted without express written
authority. Offenders will be liable for
damages. All rights, including rights
created by patent grant or registration
of a utility model or design, are
reserved.
English
Doc. Gen. Date: 02.05
2004
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.
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Medical Solutions
Table of Contents3
1-0Table of Contents
1 _______ General Information______________________________________________ 5
6 _______ Changes to previous version _____________________________________ 46
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General Information5
1General Information
2-
Additionally Required Documents0
•ARCADIS Orbic Operating Instructions
•ARCADIS Orbic System Wiring Diagram
•IQ test (quality assurance)
•Image intensifier laser light localizer (optional) assembly and setting instructions
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6General Information
Tools, aids (partially for IQ test)0
• Tool kit97 02 457 Y1971
• Dynamic test kit37 90 156 X1963
• Copper filter set44 06 120 RV090
• Densitometer97 02 416 Y1996
• Radiation filter set (incl. 25 mm Al)97 98 596 G5321
• Resolution test28 71 820 RE999
• Safety tester (leakage current and ground wire testing device)
e.g. Unimed 1100
(Leakage current measurement only required in the case of a
deviation of the local line voltage from the system delivery status).
51 38 727 Y0766
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General Information7
Note on the log book0
The log book is located in the monitor cart behind the keyboard. It is accessible if the
cover on the back of the monitor cart is removed.
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8General Information
Notes on adapting the power plug to local conditions.0
The customer can have the power plug on the supplied power cable replaced with an
appropriate local plug by an electrician, provided that:
•The power plug used can conduct the power required for the operation of the ARCADIS
Orbic (refer to current and voltage values stated on the line voltage label, back of monitor cart).
•The required line internal resistance is reached (refer to ARCADIS Orbic Planning
Guide).
•The selectivity of the fuse protection is assured - according to the relevant national
standards.
It must also be ensured by the customer that connection to an unsuitable power supply is
prevented (e.g. by identification or design measures).
As concluding measures, perform and document protective ground wire measurements
(in Germany, e.g., in the medical device book).
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General Information9
Note on the power connection0
The system delivery state is provided by the power connection values on the the line voltage label (back of the monitor cart). Necessary adjustments to local conditions are to be
performed as necessary according to the adjustment instructions of the ARCADIS Orbic
system.
WARNING
Danger high voltage!
Disregarding safety precautions can result in death or serious
bodily injury.
¹ Before the line voltage is adapted, the power plug on the
UPS in the monitor cart must be pulled out, since the
monitor cart is not free of voltage after the power plug is
pulled out.
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10General Information
Notes on equivalent leakage current measurement0
Applicability and regulations for regional companies0
The equivalent leakage current must be measured where applicable under the requirements of DIN VDE 0751 Part 1. Outside of the scope of application of DIN VDE 0751, the
following rules are to be adhered to for the regional companies: (also see ARTD part 2,
Security Rules for Assembly 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 value0
The equivalent leakage current measurement was performed at the factory and the measured value was entered in test protocol 1b. The measurement was made at the line voltage and line frequency recorded in test protocol 1b. The test protocol 1b is filed in the log
book, register 3. When the line voltage and line frequency match, the value recorded in
test protocol 1b is to be transferred as the initial measured value to the equivalent leakage
current/protocol.
If the local line voltage or line frequency deviates from the delivery state of the ARCADIS
Orbic, the values listed in test protocol 1b are invalid. The values are to be labeled invalid.
(Check the comment "values invalid" and confirm with name, date, and signature). The
equivalent leakage current measurement must be repeated. Perform the measurement
according to DIN VDE 0751, Part 1 (see ARTD, Part 2), and record the determined value
as the initial measured value. This value must not exceed the maximum value for equivalent leakage currents for devices according to IEC 601 Part 1/VDE 0750 Part 1 of 2 mA.
The initial measured value is to be entered in the equivalent leakage current protocol
(General Startup / p. 14). Comply with the measuring arrangement according to
(Fig.2/p.16). The system must be switched on during the measurement. When the
Bender safety tester is used, this must therefore be set to manual measurement. Separate the page with the protocol from these instructions and file it in the log book, system
folder.
Repeat measurement0
When service or repair work is performed on the primary power supply circuit (e.g. repairs
to the power-on circuit or replacement of the line filter), the equivalent leakage current
measurement must be repeated. Comply with the measuring arrangement according to
(Fig.2/p.16). The system must be switched on during the measurement. When the
Bender safety tester is used, this must therefore be set to manual measurement. The values measured in the repeat measurement may not exceed the threshold value of 2 mA as
specified in VDE 0751, Part 1 (see also ARTD, Part 2). In addition, they may not exceed
the initial measured value by more than 50%. The system must be repaired if the limit is
exceeded. Document the measured value in the equivalent leakage current protocol.
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General Information11
Safety instructions0
•When performing the work steps and checks, the general safety information for medi-
cal products must be observed.
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12General Information
Switching the system to be free of voltage0
•To switch the system to be free of voltage in all its parts, bring the system switch
into the OFF position.
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Medical Solutions
General Information13
Parts conducting voltage after system OFF and/or with power
plug pulled out
Main system control board D1 and power board D20
WARNING
Monitor cart, monitors and image system0
WARNING
Danger high voltage!
When the system is switched off, there is still electrical voltage on
boards D1 and D2 of the main system.
Disregarding safety precautions can result in death or serious
bodily injury.
¹ Therefore before working on one of these boards, make
sure that the LED V400 has gone out. This is the case 3
minutes after the ARCADIS Orbic system is switched off.
Danger high voltage!
When the system is switched off and even when the power plug is
pulled out, the line voltage is still applied to the power assembly of
the monitor cart, to the monitors and to the image system.
0
Disregarding safety precautions can result in death or serious
bodily injury.
¹ Before work is done on the monitor cart, the power plugs
must be pulled out of the UPS.
WARNING
X¹ These checks and adjustments are explicitly designated
Dangerous radiation during checks and adjustments!
Risk of death or serious bodily injury!
¹ For checks and adjustments that must be performed with
the radiation switched on, the prescribed radiation safety
measures must be observed; if necessary, wear radiation
protective clothing (see also ARTD-002.731.02.xx.xx and
ARTD-002.731.38.xx.xx “General Guidelines for Technical Service”).
on the following pages with the radiation warning symbol.
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14General Startup
2General Startup
3-
Power line connection0
Measuring the Power Line Voltage0
•Measure the voltage and frequency at the intended outlet for the ARCADIS Orbic sys-
tem.
•Compare the measured line voltage with the line voltage label on the back of the moni-
tor cart.
¹ The measured voltage must agree with the voltage read off from the label.
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Medical Solutions
General Startup15
The line voltage can be adapted at the transformer in the monitor
cart.
WARNING
Adapting the line voltage0
•Remove the back, bottom covers (Fig.1/p.15) from the monitor cart.
•Pull the power plug out of the UPS in the monitor cart.
•Adapt the voltage by changing the connections to transformers T1 and T2. Refer to the
ARCADIS Orbic wiring diagram.
Danger high voltage!
Disregarding safety precautions can result in death or serious
bodily injury.
¹ Before the line voltage is adapted, the power plug on the
UPS in the monitor cart must be pulled out, since the
monitor cart is not free of voltage after the power plug is
pulled out.
0
Fig. 1:Monitor cart line voltage
Pos. 1Power plug
Pos. 2T1 and T2
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16General Startup
Measuring the system leakage current0
NOTE
Perform the system leakage current measurement only if the line
voltage on the ARCADIS Orbic system must be adapted to the local line voltage.
See also (Notes on equivalent leakage current
measurement / p. 10)
Measuring arrangements for system leakage current with tester VDE 0751 October 2001 (preferred measuring method)
0
Fig. 2:Measuring circuit for measuring the system leakage current according to the differential
current method
•Perform measurement configuration according to (Fig.2/p.16). Application part
(1/Fig.2/p.16) is not available in ARCADIS Orbic.
•Perform measurement and repeat measurements.
•Document the measured values in the "Leakage current test protocol", (Leakage cur-
rent measurement / p. 40).
Measuring arrangements for system leakage current with tester VDE 0751 October 1990 (e.g. Bender tester)
0
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Medical Solutions
General Startup17
Fig. 3:Measuring circuit for the direct measurement of the system leakage current
•Measurement configuration according to (Fig.2/p.16) application part
(1/Fig.3/p.17) is not available in ARCADIS Orbic.
•For safety reasons, place the system on an insulated base.
•Perform measurement and repeat measurements.
•Document the measured values in the "Leakage current test protocol" (Leakage cur-
rent measurement / p. 40).
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18General Startup
Function check of the emergency stop switches0
•Connect the system to the voltage and boot it.
•Click "Emergency" for the patient registration.
•Activate the EMERGENCY STOP switch on the C-arm.
•The safety switch moves audibly and the following message appears on the lower left
monitor edge: "The emergency stop has been pressed"
•Disengage the EMERGENCY STOP switch.
•The safety switch moves audibly and the following message appears on the lower left
monitor edge: "The emergency stop switch has been released."
•Document the function of the EMERGENCY STOP switch in the "Test protocol, C-arm
movement and emergency stop (C-arm movement and emergency stop / p. 39).
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General Startup19
Checking the temperature indicator0
•Check the temperature indicator on the outside of the image intensifier housing.
¹ If the inner, square field of the indicator is white, the temperature has not been
exceeded. Remove the temperature indicator.
¹ If the indicator is discolored (inner field black), proceed according to IQ docu-
ment RXD0-000-038.01.xx.xx.
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20General Startup
Functional checks0
Operation of the ARCADIS Orbic, see operating instructions
•Stand and C-arm system movements
X
X
•Semi-transparent slot and iris diaphragm in fluoroscopy procedure.
•Collimation of the semi-transparent slot and iris diaphragm using fluoroscopy proce-
dure.
•Mechanical functions of the monitor cart
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General Startup21
Checking the ground wires0
•The system must be free of voltage.
•Measuring instru-
ment:
•Measuring instru-
ment:
Ground wire testing device; e.g. safety tester Unimed 1100
Max. 0.2 Ohm (observe country-specific regulations!) (current:
10 A)
•Test procedure:Measure between all touchable, conductive parts of the system
and the ground wire at the ARCADIS Orbic power plug.
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22Specific system settings
3Specific system settings
4-
System configuration0
•Please clarify in advance with the customer whether the following system configura-
•Enter the 6-character password and click OK (see system folder for password).
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24Specific system settings
Customer address configuration0
Fig. 6:Configuration_
•Select <Configuration>.
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Specific system settings25
Fig. 7:Configuration
•Click <Next>.
Fig. 8:Configuration_Local Host
•Click <Site Info>.
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26Specific system settings
Fig. 9:Configuration_Local Host_Site Info
•The marked customer-specific data may be adapted. Under no circumstances can you
change the "serial no." or "station name".
•Click <Save>.
•Click <Home>.
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Specific system settings27
Main system configuration0
•Select “Main system” in the service software (see Fig. ...).
Fig. 10: Main_system
•Click <Main system>.
Fig. 11: Main system_
•Select ARCADIS Orbic and click <Next>.
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28Specific system settings
Fig. 12: Main System_Configuration_Buzzer
•Under Configuration click <Buzzer>.
Make changes according to the following description:
•Block time settings
- Warning time limit: The buzzer sound starts when the entered radiation time has
elapsed.
- Block time limit: After the entered radiation time has elapsed - without reset of the
“warning time limit" - the radiation is blocked the next time it is selected. Every reset
of the “warning time limit” also resets the “block time limit” to “0”.
•Buzzer mode (direct, cassette)
- After exposure:Buzzer sound after the exposure.
- During exposure:Buzzer sound during the exposure.
•Buzzer mode (indirect, I.I.)
- Buzzer off:Buzzer sound off. Exceptions: Push mode and “warning time limit” has
ended.
- Buzzer on: Buzzer sound always during radiation.
The country-specific regulations must be observed for the max. fluoroscopy time and radiation blockage.
Factory setting:
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Specific system settings29
Fluoroscopy alarmFluoroscopy blocking
USA
Service mask
input in 1/10 min.
Europe
Service mask
input in 1/10 min.
4.5 min.
45
5 min.
50
5 min.
5
10 min.
50
•Make country-specific changes and click <Save>.
•Click <Home>.
•If a change is made to the fluoro time, check this function.
Country-specific adaptation of the maximum tube current0
NOTE
•Start service program and log in as described under "Service Login".
A maximum tube current limit is required - as far as known - only
in Denmark.
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30Specific system settings
Fig. 13: Main_system
•Click <Main system>.
Fig. 14: Main system_
•Select ARCADIS Orbic and click <Next>.
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Specific system settings31
Fig. 15: Main System_Configuration_Current Limitation
•Click <Current limitation>.
•Make country-specific changes (only Denmark) and click <Save>.
•Click <Home>.
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32Specific system settings
Backup0
NOTE
A backup must be created following software installation, every
software update, and every system adjustment.
•Select "Backup & Restore" in the “Service Software Home Menu”
•Place the backup CD (located in the monitor cart service compartment) in the CD ROM
drive.
Fig. 16: Backup & Restore_Command
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Specific system settings33
•Select the <Backup> command.
Fig. 17: Backup & Restore_Command_Backup
•Select the respective drive under “Drives”.
- Save to CD ROM (standard save).
Fig. 18: Backup & Restore_Command_Backup_Packages
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34Specific system settings
SW - Settings02
•Select “SW-Settings02” under Packages.
• Click <Go> and wait until the message “Ready” appears in the footer.
- Wait until the message “Ready” is displayed in the footer
ExamSet
•Select “ExamSet” under Packages.
•Click <Go>
- Wait until the message “Ready” is displayed in the footer
Security-Settings
For systems with HIPAA configuration
•Select “Security-Settings” under Packages.
•Click <Go>
- Wait until the message “Ready” is displayed in the footer
MainSystem
•Select “MainSystem” under Packages.
3D-Settings
•Under packages, select “3D settings”
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Specific system settings35
•Click <Go>
- Wait until the message “Ready” is displayed in the footer
Exiting Backup
•Close the window via <Home>.
•Remove the backup CD ROM from the CD ROM drive.
•Store the CD ROM with the other system documentation.
NOTE
It is not possible to perform a backup of the database (patient images)!
Store the patient images in an archive.
Saving to CD-ROM as long-term archive is prohibited.
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36Final work steps
4Final work steps
5-
Paper printer (optional)0
NOTE
The software (driver) for the supplied printer was preinstalled at
the factory.
Sony printer LPR-1000MD0
Perform the following steps according to the "Startup Manual" of the printer:
•Unpacking (see the chapter "Preparation").
•Installing the head cassette (see the chapter "Preparation").
Please note: Remove retaining mechanisms and safety mechanism from the head
cassette.
•Installing the ink cartridges (see the chapter "Preparation").
•Switching on the printer (see the chapter "Preparation").
Please note:Place the printer in advance on the monitor cart, connect the power and
USB cables (ready for use in the printer slot of the cart) to the printer, and set the power
switch to "1".
•Installing the head cleaning unit (see the chapter "Preparation").
•Installing the automatic paper feed tray (see the chapter "Preparation").
NOTE
Insert printer paper with the white side facing “down”.
Remove the protective film from the ink cartridge.
Codonics printer 1660L0
Perform the following steps according to the "User Manual" of the printer:
•Transport instructions (see preface).
Please note:Unpack the printer and remove the two transport pins. Place the printer in
the cart, connect the power cable and the 25-pin plug to the printer (cables are ready for
use in the printer slot of the cart), and set the power switch to "1".
•Install the print media>(General Startup / p. 14)
NOTE
Keep the transport safety materials. They are required when replacing or shipping the printer.
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Final work steps37
Sony printer UP-D72 X0
Perform the following steps according to the user manual for the printer (CD-ROM):
•Unpack the printer.
•Fill the paper tray with paper (follow instructions on paper package).
•Plug in the USB cable.
•Print a test page after the automatic test.
•Follow the instructions on the CD-ROM from the manufacturer in the event of problems.
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38Final work steps
Final work steps0
IQ test0
Perform IQ test according to instructions SPR2-310.820.02.xx.xx.
¹ Remove the supplied IQ test protocols from the monitor cart service compart-
ment.
Configuring the network (optional) and remote service0
Configure the network according to the Configuration Guide, SPR2-310.843.02.01.xx.xx
and the remote connection according to Installation, Siemens Remote Service,
SP00-000.816.02.01.xx.xx.
Completing protocols0
After completing all adjustment work steps and check measurements, the responsible
technician must sign and date the test protocols and country-specific protocols to confirm
that all values have been correctly determined and recorded.
Completing the "ARCADIS Orbic Installation" protocol0
The manufacturer of this product requires information and the legislator 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 installation report.
You will find the report in the system folder.
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Reports39
5Reports
6-
C-arm movement and emergency stop0
System: ARCADIS Orbic
Material no.:.........................................................................
Serial number:.........................................................................
Tab. 1C-arm movement and emergency stop
MovementOK
Yes/No
Releasing/locking the brakes
Downward movement, position
1
Downward movement, position
2
The warning signals sound as
described.
Function,
EMERGENCY_STOP_button
NameDate:Initials
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40Reports
Leakage current measurement0
System: ARCADIS Orbic
Material no.:.........................................................................
Serial number:.........................................................................
Measuring arrangement: see reverse:
Tab. 2Leakage current measurement
Initial measured value
Repeat measurement
1
Repeat measurement
2
Repeat measurement
3
Repeat measurement
4
Repeat measurement
5
Repeat measurement
6
Repeat measurement
7
Equivalent
Unit leakage
current
Measuring
instrument
used, serial
no.
NameDateInitials
Repeat measurement
8
Repeat measurement
9
Repeat measurement
10
Repeat measurement
11
Repeat measurement
12
Repeat measurement
13
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Reports41
Repeat measurement
14
Repeat measurement
15
Repeat measurement
16
Repeat measurement
17
Repeat measurement
18
Repeat measurement
19
Repeat measurement
20
Equivalent
Unit leakage
current
Measuring
instrument
used, serial
no.
NameDateInitials
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42Reports
Network checklist0
Network checklist (1+)For SAP order no.:_______________________
Will the system have a network connection (HIS/RIS, Camera,
PACS)?
Mandatory for image system with network connection!
To ensure that the system is preconfigured at the factory and thus optimize installation at the customer site, we
request that you complete and return this list if a network connection is available (and used).
Person responsible for network configuration at customer site
Name:
Phone/Fax:
E-mail:
System network data
Tab. 3System network data
Not networked
Identification:
Computer name*
YesNo
Configuration/ Local host/ TCP IP address
IP address:
TCP/ IP address
Subnet mask* Configuration/ Local host/ TCP IP address
Gateways* Configuration/ Local host/ TCP IP address
General: Local AE title for:
Study transfer* Configuration/ DICOM/ General
Remarks
Network data for HIS/RIS network partner (only with HIS/RIS option)
* Configuration/ Local host/ TCP IP address
HIS/RIS*
Configuration/ DICOM/ General
Print* Configuration/ DICOM/ General
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Reports43
Tab. 4Network data for HIS/RIS
not available
Product:Version:Manufacturer:
Host properties:
Host name
TCP/ IP address* Configuration/ DICOM/ HIS RIS nodes
General Node Properties
Logical name
Application entity
AE title
Port number* Configuration/ DICOM/ HIS RIS nodes
Remark:
Network checklist (2+)
Network data for reporting console / archive system (only with DICOM Basic
option) (1)
Tab. 5Network data for reporting console/archiving system
Information on each:Reporting console/
archive system
* Configuration/ DICOM/ HIS RIS nodes
* Configuration/ DICOM/ HIS RIS nodes
* Configuration/ DICOM/ HIS RIS nodes
not available
Product:Version:Manufacturer:
Host properties:
Host name
* Configuration/ DICOM/ Network nodes
TCP/ IP address* Configuration/ DICOM/ Network nodes