MOBILETT Elara Max
Startup Instructions – System
for MOBILETT Elara Max
siemens-healthineers.com
Document Version
Siemens Healthcare GmbH reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hard copy documents correspond 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 Healthineers office to order a current version or refer to our website http://
www.siemens-healthineers.com.
Disclaimer
Siemens Healthcare GmbH 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 Healthcare
GmbH or one of its affiliates or who are otherwise authorized by Siemens Healthcare GmbH 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 Healthcare GmbH or one of its affiliates are not entitled to use this documentation without prior
written authority.
Copyright
“© Siemens Healthineers, 2022” refers to the copyright of a Siemens Healthineers entity such as:
Siemens Healthcare GmbH - Germany
Siemens Shenzhen Magnetic Resonance Ltd. - China
Siemens Shanghai Medical Equipment Ltd. - China
Siemens Healthcare Private Ltd. - India
Siemens Medical Solutions USA Inc. - USA
Siemens Healthcare Diagnostics Inc. - USA
Siemens Healthcare Diagnostics Products GmbH - Germany
Corindus Inc. - USA
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
Table of contents
1
General information
5
1.1
1.2
5
5
5
5
8
9
9
11
12
13
14
14
18
19
1.3
1.4
1.5
1.6
1.7
1.8
1.9
2
3
About the document
Safety Guidelines
1.2.1
Symbols
1.2.2
Hazard keys
Performing startup - information
Abbreviations and Terms
Integration into the local hospital network (LAN/WLAN/ portable detectors)
Portable detector handling information
Required Documents
Required Tools and Aids
System overview
1.9.1
Mobile Unit Overview - Basic Device
1.9.2
Mobile Unit - Orientation
1.9.3
Mobile Unit - Generator Operator Interface
Service software access
21
2.1
2.2
2.3
21
21
23
Service software login
Access with administrator rights
Access generator service software
Unpacking
25
3.1
3.2
25
28
Unpacking the Mobile Unit
Unpacking the mobile detector
4
Connection voltage, line power adapter, and fuse
30
5
Power cable winch
31
6
Power ON/OFF/ Lock function and battery-charging mode
32
7
Drive support
33
8
Checking the X-ray tube support arm and components
35
9
Checking the Emergency Stop function
36
Mobile Unit site-specific configuration
37
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
37
37
39
40
41
42
42
43
10
11
Keyboard (language & time settings)
Configuring the Computer Name and the local IP address (LAN) of the Mobile Unit
Configuring the local IP address (WLAN) of the Mobile Unit.
Configuring DICOM network nodes
Configuring the DICOM local settings of the Mobile Unit
Site and Customer Information
License settings
Configuring Remote Service
Portable detector
11.1
11.2
11.3
11.4
46
Determining the wireless hospital environment parameters
Start up the Access Point (detector communication)
Setting Up Access Point Scalance 774
11.2.1
Setting Up Access Point Aruba 303
11.2.2
Register portable detector
Checking the connection and charging process for detectors on the Mobile Unit
46
47
47
48
50
51
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
Table of contents
12
Detector Calibration
54
13
Clinical Exposure Index and Sensitivity Factor
57
14
Checking the X-ray field/ light field
63
15
Remote control (option)
66
16
Checking the “X-ray on” warning indicators
68
17
Pending hotfixes
69
18
Country-specific tests (accuracy tests)
70
18.1
18.2
18.3
70
71
72
Test of kV accuracy
Test of mAs accuracy
Reproducibility test
19
Quality Tests
76
20
System Backup
77
20.1
20.2
20.3
77
78
78
Back up the generator configuration
Backup the FL-C configuration
Creating a recovery image of the system partition
21
Option: Wipe dispenser
81
22
Country-specific labeling
82
23
Safety checks according IEC 62353
83
24
Final Work Steps
84
25
Measuring Equipment and Measuring Instruments Used
85
26
Finalize Startup Report
86
27
Changes to Previous Version
87
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
1 General information
1 General information
1.1
About the document
This document describes technical checks that are to be carried out at first startup for the Mobile Units product.
1.2
1.2.1
Safety Guidelines
Symbols
Warning about ionizing radiation or radioactive substances. Tests and adjustments that must be performed
with the radiation switched on are indicated by this radiation warning icon.
Dangerous electrical voltage > 25 V~ or > 60 V-.
Caution! General hazard warning.
ESD: Warning about electrostatically sensitive components.
Report icon. Used to indicate entries in certificates.
1.2.2
Hazard keys
WARNING
Risk to non-involved persons: Installation, maintenance, and servicing are not performed in the intended
place of use.
During such work, and especially with covers removed, contact with dangerous high voltage is
possible even if the system is switched off.
◆ Always ensure that the work area is secured against any unauthorized persons and live animals.
◆ The work area must be marked as dangerous, e.g., with warning tape and/or a warning sign.
◆ Never leave the work area unattended. It should be a lockable room. If such a room is not available,
the unit must be completely covered, switched off, and secured against unintended use.
◆ Use only measurement equipment and devices that are suited to the task.
◆ Read and observe the warning labels on the cabinet.
◆ Risk of electric shock (working on live lines can cause electric shock)
◆ Risk of death, serious physical injury, or damage to property.
hm_serv_PV_SI_general
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1 General information
Fig. 1: Warning sign
WARNING
Repair or maintenance by untrained personnel.
Injury to persons or damage to the system.
◆ Every person who adjusts, configures, maintains, services or repairs this system must have certified
product training.
hm_serv_PV_trained_personnel
WARNING
After completing the work:
◆ Switch the system off and back on. Make sure that the "service switch active" error is not displayed.
hm_serv_ClosedHWloop
WARNING
Disabling of safety mechanisms during installation, maintenance and repair
Serious injury to technician
◆ Avoid overriding the safety mechanisms. If this is unavoidable, work with extreme caution.
hm_serv_SafetyMechanisms
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1 General information
CAUTION
Releasing radiation
Contamination of personnel exposed to radiation unnecessarily
◆ Checks and settings for which radiation must be released are marked with the radiation warning
symbol.
Radiation protection measures must be used. Wear radiation protective clothing. Use the radiation
protection equipment. Maintain the safety distance. Wear a pen dosimeter or a radiation monitoring
badge to monitor your personal radiation exposure.
hm_serv_functional_checks
WARNING
To avoid electric shock from components under voltage, also be aware that:
The capacitors of the capacitor bank (DC 400 V on the capacitor bank) can be electrically charged
even when the system is switched off and the power cable is disconnected!
Individual capacitors of the capacitor bank may have been disconnected from the discharging
circuit, erroneously or as a result of failure, and can still be electrically charged!
◆ Disconnect the battery blocks for maintenance and service work!
◆ Make sure that no parts or tools fall into the unit.
Do not touch potentially dangerous components.
If loose parts must be removed from the unit, use only insulated tools;
Protect the work area so that no other persons are able to touch the unit while the covers are removed!
hm_serv_Voltage_after_shutdown
CAUTION
Touchable DC high voltage (400 V) on the capacitor bank with housing covers open and safety covers
removed even when the system is switched OFF.
Serious injury or danger to life.
◆ Verify that areas with possible dangerous voltage are voltage-free.
hm_serv_Voltage_after_shutdown
CAUTION
Contact with blood or other bodily fluids
Risk of infection.
◆ Have the parts disinfected by operating personnel.
◆ Wear protective gloves.
hm_serv_WearGloves
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1 General information
WARNING
Incorrect handling of the battery: The portable detector battery can be damaged due to incorrect
transportation, handling or storage.
Incorrect handling of the battery pack can result in the following consequences:
Acid leakage, overheating, smoke emission, bursting, and/or ignition of the battery pack.
◆ Handle the battery with care. Avoid incorrect handling, transportation or storage.
hm_serv_detector_battery
WARNING
Detectors: This includes permanently installed and mobile detectors, as well as detectors from third party
suppliers.
Toxic Materials
Risk of toxic contamination if the detector panel is broken by mechanical shocks.
◆ Detectors must be handled with care! If a detector is defective, do not use it. The detector must be
checked as to whether parts are damaged or broken off or weather any particles have spilled. Brokenoff objects must be collected and placed in a sealed container and returned to Siemens.
hm_serv_detector_toxic_material
1.3
Performing startup - information
1 Additional instructions and reports are required to start up a Mobile Unit:
• Startup Report
• Safety checks according to IEC 62353 - Instructions and report
• Operator manuals if certain workflows are not familiar.
Operator manuals belonging to an X-ray system must be available locally.
2 Any defects or deviations determined during startup must be corrected during or after the startup visit:
• Defective parts must be replaced
• Defined setting values are readjusted if necessary
• Malfunctions must be clarified and corrected
3 Requirements for the work area for startup.
For the startup of a mobile unit in a customer environment, the following work area requirements apply:
•
The area must be fulfil the rules for radiation protection corresponding to a mobile X-ray device
• The power supply range can vary between 100 V AC and 240 V AC. The system automatically adjusts to
the local line voltage. Ensure that the power supply is electrically fused with a min. 16A automatic circuit
breaker.
•
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The area must be secured against unauthorized persons.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
1 General information
1.4
1.5
Abbreviations and Terms
Abbreviation and terms
Definitions
FL-C
Fluorospot Compact imaging system
HDD
Computer hard disk drive
wi-D
Wireless detector (flat detector)
DAP
Dose Area Product measuring system
HIPAA
Health Insurance Portability and Accountability Act
SSW
Service Software (FL-C imaging system PC)
WLAN
Wireless LAN
Integration into the local hospital network (LAN/WLAN/ portable detectors)
Fig. 2: Integration into the local hospital network (LAN/WLAN/ portable detectors)
Port 3 LAN to the hospital network environment
Port 2 Mobile Unit Client Module (Access Point) (AP 2) SCALANCE (722) for wireless connectivity to the
hospital network environment
Port 1 Mobile Unit Access Point (AP 1) ARUBA (303) (Scalance W774) for wireless connectivity to the detector
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1 General information
The internal network of the Mobile Unit includes:
The internal network of the Mobile Unit includes (FL-C computer):
• The network adapter to the hospital network environment (LAN)
• The network adapter to the Client Module (Access Point) [SCALANCE (722)]
Configure this module (Access Point) if a wireless network is available for the hospital network environment.
• The network adapter to the Access Point [Aruba 303/ Scalance W774], which connects the portable X-ray
detector to the Mobile Unit.
Access Point AP 1 - Information - (Mobile Unit to the detector)
• When a Mobile Unit is delivered from the factory, the Access Point (AP 1) is already initiated and configured.
"TuneUp" >> "Detector" >> "Access Point Configuration"
Depending on the hospital network environment, it may be necessary to adjust the AP wireless network
settings to improve network utilization.
Factory settings of the Access Point regarding the detector are:
• Wireless LAN protocol: 802.11n
• Frequency band: 5 GHz
• Frequency channel: (44)
• SSID: xxxxxx (for example: MOBILETT Elara_Serial No)
• IP address 192.168.37.101
Use the 802.11n standard (5 GHz, 2.4 GHz) channels as specified in the country list.
It is recommended within a hospital environment to reserve a specific frequency range and channel (5 GHz
channel/ channel) for wireless communication to avoid interference in operation and data transfer.
• If necessary, if the factory set wireless channel (44) is already in use, another channel can be configured
during the startup procedure.
• If it cannot be avoided, the frequency band can be changed from 5 GHz to 2.4 GHz
Restriction: At 2.4 GHz, only channels from 1 - 11 may be used (channels 12 and 13 have no function)
Access Point hardware is country specific. For example, the following hardware is used for the Aruba 303
model type:
• RoW = Rest of World (mat. # 11427009)
• US = USA (mat. # 11427010)
• JP = Japan (mat. # 11427011)
• EG = Egypt (mat. # 11427012)
• IL = Israel (mat. # 11427013)
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1 General information
Client Module (Access Point) AP 2 - Information - (Mobile Unit to the hospital network environment)
• When a Mobile Unit is delivered from the factory, the Client Module (Access Point ) (AP 2) is already initiated
and pre-configured.
Based on the hospital's network environment, the Client Module (Access Point ) (AP 2) needs to be set
to the existing wireless network.
1.6
Portable detector handling information
• If a Mobile Unit is delivered with a detector, the detector has already been adapted (configured/ registered)
in the factory.
• If the option "Shared detector" is used, the detector already owned by the hospital must be registered during
the startup procedure.
The use of wireless detectors shared with this Mobile Unit is only possible if system version VF10 is operated
on all systems used.
The following detector types are possible:
• MAX mini 2430EZ wi-D
• MAX mini 1.2 2430EZ wi-D
• MAX wi-D 3543EZh-Pb
• Any detector intended to be used by this Mobile Unit must be calibrated for this device prior to operation
with patients.
• In addition, a Clinical Exposure Index und Sensitivity Factor adjustment has to be carried out.
CAUTION
Detector particles. Toxic materials.
Toxic contamination if detector panel is broken by mechanical shock.
◆ Handle detectors with care! If the detector is broken, do not use it; inspect to determine whether any
particles have spilled. Leaked particles have to be collected and kept in a sealed container. Spilled
particles have to be returned to Siemens.
hm_serv_detector_toxic_material
WARNING
If handled improperly, the batteries can overheat, leak or explode. There is considerable risk of injury.
◆ Do not open the batteries, short-circuit them or expose them to flame.
To charge them, use only chargers that meet manufacturer's specifications.
Dispose of them according to legal regulations.
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1 General information
CAUTION
Incorrect handling of battery pack can result in possible consequences: acid leakage, overheating, smoke
emission, bursting and/or ignition of battery pack.
Explosion or fire
◆ Handle the battery with care. See battery pack manual
hm_serv_detector_battery
1.7
Required Documents
Document Title
Document ID
General safety information
TD00-000.860.01.xx.02
Product-specific safety information
XPR8-280.860.01.xx.02
Safety check according to IEC 62353
XPR8-000.833.01.xx.xx
Safety check according to IEC 62353, report
XPR8-000.333.01.xx.xx
Installation report (available as PACE form)
XPR8-280.315.01.xx.xx
Operator Manuals for Mobile Unit
XPR8-280.620.01.xx.xx
Operator Manuals for FL-C
XPR8-280.621.01.xx.xx
Mobile Detector Frequency Channels Lists, SCALANCE W774 -1 RJ45 / country list
(optional)
XPRF-000.843.06.xx.02
Remote service RFU/configuration
XP00-SRS.843.02.xx.02
WLAN DICOM Client W722 configuration/advanced (optional)
XP00-WLA.814.13.xx.02
WLAN / Wi-Fi measurement tool
TDIT-WLA.840.02.xx.02
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1 General information
1.8
Required Tools and Aids
Fig. 3: Unpacking tools
Tools, test equipment, and aids
Material No.
• Standard tool kit (“Tool kit, basic unit”)
09702457
• Warning label
09900275
• Keyboard, KB400, standard English
10590416
• FL-C mouse V6
10143628
• A USB hub is recommended
• Measuring device for leakage current, e.g.:
5138727
• Grounding measuring device, such as: SECUTEST
4415899
• 2.1 mm precision copper filter
9900598
Alternatively, copper filter set (10 x 0.3 mm CU)
4406120
• 0.6 mm copper filter
delivered with unit
• Dose measuring device, e.g.: PTW DIADOS
9717612
• Densitometer, e.g.: DensiX-LE 52003
4951286
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1 General information
• Digital multimeter, such as: Fluke 8060 A
9702101
• DXR = direct X-ray ruler, such as the Unfors DXR Direct X-Ray Ruler
9660051
• Test phantom, such as: Wellhöfer DIGI 13
7441145
• Thermometer min. scale 10° C to 32° C
*a)
• Radiation protective clothing
at customer site
• 3 blank writeable data media: one CDR and two DVDs
n.a.
• USB storage device, 32 GB
n.a.
• Unfors RaySafe™ kV meter and mAs meter
a)
1.9
1.9.1
Use the thermometer included in the detector packaging.
System overview
Mobile Unit Overview - Basic Device
• Basic Device
Fig. 4: The system from various angles
Item
System part
Item
System part
1
Generator User Interface
12
Front wheels (self-steering)
2
Motor drive handlebar with dead man switch
13
Main power plug (cable retractor)
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1 General information
Item
System part
Item
System part
3
USB and Ethernet connections
14
System arm hook for “Arm Park”
(sensor for plug registration)
4
Compartment with infrared detection for detec‐
tor attachments and service buttons
15
Collimator
5
External CD/DVD drive
16
X-ray single tank
6
Detector compartment
17
Lead apron hanger (one on each side)
7
Mechanical wheel brake
18
Exposure switch (mechanical)
8
wi-D (including charging pin mechanism)
19
Rear wheels - (motor-driven)
9
Touch screen (FL-C monitor)
20
Micro-move buttons (3 on each side)
10
Option: Remote control - X-ray release and colli‐
mator light ON/OFF
21
Wipe dispenser (optional)
11
Exposure X-ray signal LED bar
n.a.
n.a.
Tab. 1: Fig.: The system from various angles
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1 General information
Fig. 5: Rotating or swiveling components
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No.
Points of movement
1
Collimator turning
2
Fork for single tank: turns the single tank forward and back (anterior/posterior, AP)
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1 General information
No.
Points of movement
3
Fork for single tank: turns the single tank right and left (dexter/sinister, DS)
4
Upper arm hinge
5
Lower arm hinge
6
Arm hinge (180° horizontal)
Tab. 2: Arm ranges of motion
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1 General information
1.9.2
Mobile Unit - Orientation
Fig. 6: Unit orientation
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Abbreviations
Explanation
Uv
User view
L
Left side of unit (left)
R
Right side of unit (right)
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1 General information
F
Front (front)
fw
Front wheels (front wheels)
sa
Support arm (support arm)
T
Tube (single tank)
C
Multileaf collimator (collimator)
dd
DAP display (dose display)
Tab. 3: Mobile Unit orientation aspects
1.9.3
Mobile Unit - Generator Operator Interface
Fig. 7: Details on back of unit
Generator user interface
Detector compartment
(1) Power switch
[1] Compartment flap – infrared connector for detector attach‐
ment is behind this area (red square with dash lines)
(2) Keypad main power ON/OFF and lock in standby
[2] External CD/DVD drive for the FL-C PC
(3) kV - 7-segment display
[3] Optional: Space for snap-on grid
(4) mAs - 7-segment display
[4] Transport space for wi-D detector (Pixium FE3543pR) with a
charging mechanism
[5] Collimator light ON/OFF
[5] Storage space for wi-D battery (no charging function - transport
only)
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1 General information
(6) System battery status bar LED
Left LED: red light when not usable before charging.
Right LED: yellow while plugged into main power
[6] Storage space for one “Max mini detector” (no charging func‐
tion - transport only)
(7) X-ray circuit control LED - green and X-ray release [7] Infrared sensor for plugged Ethernet cable [9]
LED - orange
(8) Safety system stop
[8] Two USB sockets
[9] Ethernet socket for a LAN connection
[10] Infrared sensor for wi-D attachment and
Service buttons below
Tab. 4: Generator Operator Interface
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2 Service software access
2 Service software access
General access information about the service software and modules.
2.1
Service software login
✓ The Mobile Unit is switched on.
1 Connect the USB keyboard and mouse.
2 If the HIPAA option is already configured, proceed by clicking “Emergency” to open the User Examination
screen
3 From the UI navigate to the service software.
4 Enter the service key (if necessary, contact your support center to obtain one).
Fig. 8: Access to the service software
2.2
Access with administrator rights
A login with administrator rights is required for certain service software (SSW) pages or configurations and
settings via the SSW.
Perform the following procedure when prompted:
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2 Service software access
Fig. 9: User Account Control
1 Within the local service software (SSW), navigate back to the service main page (e.g.: using the “Alt” +
“Tab” key combination).
2 Select FLC Service and then click System Settings.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
2 Service software access
Fig. 10: User Account in service
3 Click Admin Credentials.
• For “User” = cse the password is automatically created and appears.
• Copy the generated password via the Ctrl + c keys of the keyboard.
4 Navigate back to the “User Account Control window” and select Yes.
5 Type in the user name cse and paste (Ctrl + v) the password from the previous step.
6 Confirm with OK and proceed with the service activity.
2.3
Access generator service software
To log in to the Mobile Unit Generator Service Software (PMS) pages for configurations, settings, or
adjustments perform the following procedure:
If the entire screen turns black after entering the service software use the key combination Alt + Tab on the
keyboard to get back to the service screen.
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2 Service software access
All configuration and settings are stored in one view under “Local Generator Tools/ Technical Service / Unit
Configuration”. This page includes a “Save to File” button. It provides a quick, complete overview of all the
currently configured data (except the 4-digit keypad pin).
Configure all user relevant data first and then press “Save to File”. It will be stored under:
C:\Addon\MobilGenerator\SettingsFile\Settings.txt.
✓ For changed values to take effect, the SERV button must be ON before changing values.
✓ The local service software of the Mobile Unit is opened.
◆ Open the local service software and select Tune Up and then Local Generator Tools.
The generator service software appears.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
3 Unpacking
3 Unpacking
The results of checks must be recorded in the Startup - Report.
3.1
Unpacking the Mobile Unit
A space of at least 5 m in length and 3 m in width for the crate is required to unpack a mobile unit in order
to drive the mobile unit out of the box via the ramp onto the floor. Additional space is necessary for the
pallet truck to position the crate.
Fig. 11: Unpacking space
✓ Have unpacking tools ready such as a pallet truck, screwdriver, hammer, pry bar, knife, and wrench set.
1 Position the box in such a way that the MU can be driven down via an installed ramp. The crate side "R" =
"Ramp" is the ramp that will later be created on the opposite side.
Fig. 12: Positioning the crate
2 Open or remove any attached metal tabs or brackets from the crate.
Fig. 13: Metal tabs or brackets from the crate must be opened
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3 Unpacking
3 Remove first the top, then the front (smaller side) marked with an "X" to access the separate boxes inside.
Fig. 14: Packing overview
4 Remove all items and boxes from inside:
• Mobile Unit accessories and documents
• Optional - detector(s), charging unit for detector batteries, extra detector batteries and grid.
5 Remove one of the side wall and then remove the last narrower side wall marked "R". This wall is used as
a ramp to move the mobile unit down from the pallet.
Make sure that when removing the last side parts they do not fall over uncontrollably.
6 Remove the plastic bag from the Mobile Unit.
7 Unscrew the transport safety mechanism on the single tank fork. Remove the foam material protecting
the arm and push the arm into the park position.
Fig. 15: Remove transport mechanism from the STU fork
8 Remove the transport safety mechanism on the sides (bumper) and rear of the Mobile Unit.
If necessary, the Mobile Unit must be briefly lifted with a lever arm (use transport safety rail removed)
in order to remove the bumper.
• To remove the transport safety rail on the large drive wheels, loosen the "drive support" of the Mobile
Unit and move the device a few centimeters towards the ramp until the rail fastening screws can be
reached from below.
As long the drive support is uncoupled, the Mobile Unit is not braked! Secure against rolling away!
Do not damage the covers on the bottom of the Mobile Unit.
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3 Unpacking
Fig. 16: Transport safety mechanism
Fig. 17: Unpacking
Fig. 18: Remove the transport safety rail next to the large wheels
9 Couple the drive support.
10 Place the ramp (marked “R”) flush against the front of the pallet.
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3 Unpacking
11 Move the Mobile Unit from pallet.
• Open the service flap at the rear of the Mobile Unit and activate the “TRANSPORT” button.
• Switch the system on and enter the original factory key code 1111 for motor movement.
• Carefully drive the Mobile Unit down the ramp.
Fig. 19: Service flap with "Transport" service button
Fig. 20: Mobile Unit switched on
12 Inspect the Mobile Unit for visible damage and ensure that covers are correctly seated.
• Inspect the STU (single tank unit) housing for damage.
• Inspect the collimator attachment and housing for damage.
• Inspect the covers of the Mobile Unit for damage and ensure correct seating (fixed screws).
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3.2
The Mobile Unit has been inspected for visible damage and to ensure that covers are correctly
seated (fixed screws).
Unpacking the mobile detector
• If a mobile digital flat detector has been shipped, unpack it and check items for damage.
• If the "shared detector" option is used, skip this section.
Any new detector is shipped:
• in a thermo pack,
• with detector batteries and
• an optional detector battery charger
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
3 Unpacking
Fig. 21: Detector Packaging
✓ Allow the detector to acclimate for at least 1 hour in the Mobile Unit "Startup" environment before use!
1 Open the transport crate and remove the detector.
2 Open the plastic thermo bag.
3 Remove the protective film from the detector.
4 Check the detector for visible damage.
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The detector has been checked for visible damage.
5 Unpack the detector battery or batteries and the external charger.
6 Connect the charger to line power, insert available batteries, and check the respective battery charge level
Fig. 22: Detector battery charger
7 Use the battery with the highest charge level and insert it into the detector.
8 Insert the detector into the compartment of the Mobile Unit.
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4 Connection voltage, line power adapter, and fuse
4 Connection voltage, line power adapter,
and fuse
The power supply range for the Mobile Unit can vary between 100 V AC and 240 V AC/ 16A. The system
automatically adjusts to the local line voltage.
The results of checks must be recorded in the Startup - Report as well as in the Safety checks according
to IEC 62353 - Report XPR8-000.333.01.xx.xx.
1 According to the country, install the required power plug adapter.
2 Check the power line condition for the Mobile Unit (between 100 V AC and 240 V AC/ 16A).
• Ensure that any outlet to be used with this mobile unit is in a range of 100 V AC and 240 V AC.
• Ensure that any outlet to be used with this mobile unit is 16A fused.
• If necessary, arrangements must be made with the operator.
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The power line condition for the Mobile Unit (between 100 V AC and 240 V AC/ 16A) has been
checked.
Line power connection electrically interlocked with 16A class C or D – not B
In-house staff can be instructed to use an inrush current limiter in case a class B automatic circuit breaker is
used.
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5 Power cable winch
5 Power cable winch
◆ Inspect the power cable winch for visible damage and check for proper function.
• Pull the entire power cable (approx. 4 m) out of the power cable winch. Inspect the cable for damage.
• Verify that the function of the power cable winch is correct (automatic cable retraction).
• Clean the power cable if necessary.
Q The power cable winch has been inspected for visible damage and checked for proper function.
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6 Power ON/OFF/ Lock function and battery-charging mode
6 Power ON/OFF/ Lock function and
battery-charging mode
The results of checks must be recorded in the Startup - Report as well as in the Safety checks according
to IEC 62353 - Report XPR8-000.333.01.xx.xx.
1 Connect the power cable to the line power socket.
• The Mobile Unit changes to "Mains mode", which lights up.
• The system battery charge mode starts.
• Drive support is not yet active.
2 Check that the battery charging mode is active.
• The plug-in LED lights up on the generator user interface.
• 6 yellow LED bars light up (running lights from left to right).
Q The battery charging mode has been checked.
3 Turn the Mobile Unit ON if it's not already on.
Depending on option installed, use the key switch or power button.
• The system power button lights up.
• FL-C starts if it's not already up.
• Drive support is active (slow speed).
4 Inspect the kV and mAs display for damage.
• With the Mobile Unit on, the parameters for kV and mAs are correctly displayed. Numbers are correctly
displayed.
Q The displays for kV and mAs have been checked.
5 Turn the Mobile Unit from ON to Lock.
Depending on option installed, use the key switch or power button.
• The screen saver is active and operation is not possible until the 4 - digit code is entered on the keypad.
6 Turn the Mobile Unit from LOCK to OFF.
Depending on option installed, use the key switch or keypad.
• The Mobile Unit switches off.
• The system battery charging mode remains in operation.
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The function of the OFF/ ON/ LOCK has been checked.
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7 Drive support
7 Drive support
The results of checks must be recorded in the Startup - Report.
Before checking the drive support function, check the system battery charge state:
• Open the rear flap and activate the “TRANS” button.
• Evaluate the charge state as follows:
- If the charge level is ≥ 50%, continue with the drive support test (at least 2 yellow LED bars of the power
status indicator should be lit).
- If the battery level is < 50%, it is recommended to charge the system battery first.
Fig. 23: Access the service “TRANS” button
1 Make sure that the device is stable even when the motor is uncoupled and cannot roll away (total
weight more than 400 kg).
2 Uncouple the drive support.
3 Check the ability of the Mobile Unit to move with the drive support disconnected.
• Check the quality of the movement of the Mobile Unit.
• The movement should be possible without grinding or squeaking noises.
Q The mobility of the Mobile Unit was checked with the drive support disconnected.
4 Couple the drive support again.
5 Check brake behavior when drive support is coupled.
• Test the braking behavior in the coupled state without actuating the DMG on the drive handle. The MU
must not move in any direction.
Q The brake behavior when drive support is coupled has been checked.
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7 Drive support
6 Check the drive support function of the Mobile Unit.
• Drive forward, backward, 180° turn at fast speed.
• For slow and fast speed.
Fast speed can be activated only with the X-ray tube support arm in park position and all cables
unplugged (power cord and Ethernet)
Tube out of park - indication on kV/mAs display - SLOW PARK
Line voltage plugged in - indication on kV/mAs display (SLOW - PLUG)
Ethernet cable plugged in - indication on kV/mAs display - SLOW ETHR
With drive support active, the wireless detector is disconnected from the charging pins.
Q The drive support function of the Mobile Unit has been checked.
• Safety Mechanisms
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8 Checking the X-ray tube support arm and components
8 Checking the X-ray tube support arm
and components
The results of checks must be recorded in the Startup - Report as well as in the Safety checks according
to IEC 62353 - Report XPR8-000.333.01.xx.xx.
1 Inspect the transport lock of the X-ray support arm for visible damage and ensure proper function.
• Make sure that the support arm can be securely fastened in its holder.
Q The transport lock of the X-ray support arm has been checked for visible damage and proper
function.
2 Inspect the handles of the support arm and collimator for visible damage and ensure tight seating (fixed
screws).
Q The handles of the support arm and collimator have been checked for visible damage and tight
seating (fixed screws).
3 Inspect the collimator for visible damage and proper function.
• Make sure that the collimator knobs are tight.
• Check the collimator blades setting function by opening and closing the blades.
• Ensure that the covers and cover screws of the collimator are tight.
Q The collimator has been checked for visible damage and proper function.
4 Check the x-ray tube support arm for easy positioning.
• Move the X-ray tube support arm to different positions and ensure that the arm can be positioned easily
and securely.
Q The X-ray tube support arm has been checked for easy positioning.
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9 Checking the Emergency Stop function
9 Checking the Emergency Stop function
The results of checks must be recorded in the Startup - Report as well as in the Safety checks according
to IEC 62353 - Report XPR8-000.333.01.xx.xx.
✓ The Mobile Unit is ready for examination.
◆ Checking the Emergency Stop function
• Press the Emergency STOP button (kV/mAs display -> EMER STOP).
• The touchscreen will be deactivated (screen saver).
• The drive support is deactivated (no movement possible)
• Release of radiation is blocked.
Q The Emergency Stop function has been checked.
• Safety Mechanisms
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10 Mobile Unit site-specific configuration
10 Mobile Unit site-specific configuration
The results of checks must be recorded in the Startup - Report.
10.1
Keyboard (language & time settings)
A standard hardware keyboard (US English) is delivered with the system and is intended for servicing by the
customer administrator (if applicable) only.
✓ Access the Windows operating system: Settings > Clock, Language and Region, Language is opened
◆ Check or modify Date and Time configured in the Mobile Unit according to local requirements.
Fig. 24: Language settings
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10.2
The date and time configured in the Mobile Unit according to the local requirements have been
checked.
Configuring the Computer Name and the local IP address (LAN) of the
Mobile Unit
This network adapter configuration is to be used when the Mobile Unit is connected to the hospital network
environment via an Ethernet cable. An IP address unique within the hospital network environment can be
entered as a static IP address. If a DHCP service has to be configured (factory default), the DHCP server must
always assign the same IP address to the Mobile Unit.
If a wireless connection Mobile Unit to the hospital network environment has to be configured, follow
additional section: ( Page 39 Configuring the local IP address (WLAN) of the Mobile Unit.).
✓ The local service menu is opened.
✓ Mouse and keyboard are connected to the USB port of the Mobile Unit .
✓ The factory default is accepted by the local network administration or a new computer name to be
configured is known (Factory default: ElaraMax-xxxxx (x= system serial no.).
✓ The IP address of the LAN connection (Subnet mask, Gateway) to be used for the Mobile Unit is known,
or a static IP address is assigned via a DHCP server (the factory setting of the network adapter is automatic
for the IP address and DNS).
1 Click FL-C Service >> System.
• Click Admin Credentials to create an admin password.
• Copy the displayed admin password via [Ctrl] + [C] using the keyboard.
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10 Mobile Unit site-specific configuration
2 Open the Control Panel.
3 Navigate to System >> Advanced Settings.
• In the dialog window enter "cse" and set the cursor in the password field.
• Press [Ctrl] + [C] using the keyboard to insert the admin password.
• Confirm with the Yes button.
4 To change the factory given Computer Name of the Mobile Unit:
Factory default: ElaraMax-xxxxx (x= system serial no.)
• Click tab card "Computer Name".
• Enter or modify the customer name under Computer Description.
• Click Change.
• Enter the Computer Name accordingly.
• Press the Enter key of the keyboard.
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The computer name of the Mobile Unit has been checked.
5 To change the IP address of the Mobile Unit's LAN network adapter:
Within the Control Panel:
• Click Network and Sharing Center.
• Click DICOM Net and then Properties.
• In the TCP/ IPv4 page configure the required address accordingly.
IP address, subnet mask, gateway, etc.
• Click Ok >> OK to save changes.
• Close the window with OK and select Apply.
• Confirm to restart the computer so that changes become active.
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10 Mobile Unit site-specific configuration
Fig. 25: Example of local LAN network adapter configuration
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10.3
The IP addresses of the Mobile Unit LAN network adapter have been checked.
Configuring the local IP address (WLAN) of the Mobile Unit.
This network adapter configuration is to be used when the Mobile Unit is connected to the hospital network
environment via an wireless LAN. An IP address unique within the hospital network environment can be
entered as a static IP address. If a DHCP service has to be configured (factory default), the DHCP server must
always assign the same IP address to the Mobile Unit.
Unlike the configuration of the LAN network adapter, a SCALANCE (722) Client Module (Access Point) must
be configured for wireless access. A menu from the FL-C service area is to be used for this.
✓ The local service menu is opened.
✓ The mouse and keyboard are connected to the USB port of the Mobile Unit.
✓ The IP address of the WLAN connection (Subnetmask, Gateway) to be used for the Mobile Unit is known,
or a static IP address is assigned via a DHCP server (the factory setting of the network adapter is for IP
address and DNS = automatic).
✓ Wireless access to the hospital environment must be via the WEP, WPA, WPA2, or WPA3 security standards!
1
Log in to FLC service and go to: Configuration -> Components -> DICOM WLAN settings and click
“Start”
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10 Mobile Unit site-specific configuration
2 Configure the WLAN Client via the service document "Advanced VF10 WLAN DICOM Client W722
configuration, XP00-WLA.814.13.x.02".
•
Wireless access to the hospital environment must be via the WEP, WPA, WPA2, or WPA3 security
standards!
• IP address, Subnet mask, Gateway, DNS, (or leave it as Automatic)
• frequency band
The 5 GHz frequency band is highly recommended. If this frequency band cannot or must not be
used, 2.4 GHz can be set. In this case select a frequency channel 1 or 6 or 11, or as provided by the
customer.
• frequency channel
• SSID name
3 Close all menus.
4 Restart the Mobile Unit including the imaging system.
Change becomes valid.
10.4
Configuring DICOM network nodes
✓ The USB keyboard is connected to the USB port of the Mobile Unit.
✓ The DICOM-specific address data of the network nodes that are to be reached by the MU in the hospital
network must be available: DICOM AE titles, port, host name, service used (DICOM Send, Retrieve,
Worklist, etc.).
✓ The local service >> FL-C Service >> Configuration >> DICOM Nodes Settings is opened.
◆ Configure each network node to be reached in the network.
Existing nodes that are not used must be removed first.
Create new the following data for each network node to be configured:
• Alias - name that is visible in the operator UI
• DICOM AET
• Host name (a DNS address may be entered)
• Port No.
• Select appropriate service for each node to be configured as: Storage, Q/R, StC, Print, Worklist, MPPS
• Click Save when one node is complete.
• Continue until all nodes are entered.
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10 Mobile Unit site-specific configuration
Fig. 26: Create new all DICOM nodes to be used on the "DICOM Node Settings" page
Fig. 27: Example: DICOM node settings with DNS names
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10.5
Network nodes to be reached in the network have been configured.
Configuring the DICOM local settings of the Mobile Unit
The mobile unit's factory preset AE titles may be changed depending on the network environment.
✓ The mouse and keyboard are connected to the USB port of the Mobile Unit.
✓ If the factory settings need to be changed, the new DICOM AE Titles (DICOM Send, Retrieve, Worklist, etc.)
used for the Mobile Unit must be available.
✓ The local service >> FL-C Service >> Configuration >> DICOM Local Settings is opened.
◆ Check local AE title (Own AETs) for the Mobile Unit.
• Check the AET's and DICOM services used for the Mobile Unit on the DICOM Local Settings page.
• Modify AE titles for the specific service if required ("Own AET" area).
• If necessary, select the appropriate worklist server and/or the MPPS server in the Active Server area.
• For the service Worklist, additional settings may be configured according to local network needs
(Worklist Settings area).
• After making changes, click the Save button.
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10 Mobile Unit site-specific configuration
Fig. 28: Check Own AETs of the "DICOM Local Settings" page
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10.6
The local AETs and DICOM Services used for the Mobile Unit have been checked.
Site and Customer Information
✓ The local service => Configuration => Site Info is opened.
◆ Configure the site und customer-specific data.
Fig. 29: Customer site info
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10.7
The site und customer-specific data have been configured.
License settings
Licenses are basically preinstalled at the factory.
If an MU is delivered without a customer-specific configuration, any licenses that may have been ordered must
be installed during startup.
✓ The local service >> FL-C Service >> Configuration => License is opened.
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10 Mobile Unit site-specific configuration
◆ Check or import licenses for Mobile Unit options accordingly.
• Import the customized license.dat from the USB device, if applicable.
Fig. 30: License listed
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10.8
Licenses for Mobile Unit options have been checked for completeness
Configuring Remote Service
For more information on configuring Remote Service, refer to the document "SRS Configuration for RFU VF10:
XP00-SRS.843.04.xx.02".
✓ Mouse and keyboard are connected to the USB port of the Mobile Unit .
✓ The service software >> FL-C Service >> Configuration >> SRS Configuration is opened.
✓ The Mobile Unit is already registered in the cRSC back-end (contact the SRS Help Desk if necessary (only
one IP address of the Mobile Unit (LAN or WLAN).
✓ The Mobile Unit is configured to the local hospital network environment.
✓ The Mobile Unit is connected to the network via the cSRS registered IP address.
✓ A gateway to the SRS router is configured or if an additional gateway has to be used, the required IP address
is ready.
1 Select Central SRS Configuration.
2 Under Location, select the appropriate region (Europe/ America/ Asia).
Outside NAT is not used.
The address data for the remote and system management services are set automatically.
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10 Mobile Unit site-specific configuration
Fig. 31: Select the appropriate region for the Remote services
3 Click Save and Next.
The “FTP Configuration” window appears.
The remote server will be set automatically according to the previous step.
4 Configure the FTP service of the SRS as follows:
• FTP User => “rdiagftp”
• FTP Password => “siemens ”
• Confirm password
• Cyclic transfer => mark the checkbox ☑
• Cyclic time => "seven days"
• Event/Management transfer => mark the checkbox ☑
The configuration can be verified with the Test FTP button.
Fig. 32: SRS FTP settings
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FTP service of the SRS has been configured.
5 Click Save and Next.
The System Management page appears.
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10 Mobile Unit site-specific configuration
6 Activate System Management as follows:
• On the System Management page check Installation & Registration and Activation.
• Click GO.
The registration process is started.
Wait until the process is completed.
Fig. 33: Activating System Management
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System Management has been activated.
7 Select Home.
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11 Portable detector
11 Portable detector
The results of checks must be recorded in the Startup - Report.
11.1
Determining the wireless hospital environment parameters
The wireless LAN settings of the Access Point are preset at the factory. Determining the wireless hospital
environment parameters is required.
If the local conditions of these parameters (refer to list below) are not provided by the local administration,
an SSID tool can be used to clarify on-site conditions in the hospital environment.
• SSID tool (Intranet / For Service / Product Information / Common Services / Service Tools)
• Use of the SSID tool is described in the document "WLAN / Wi-Fi measurement tool", TDIT-WLA.840.01.
◆ Determining the wireless hospital environment parameters.
To ensure trouble-free operation throughout the clinical area in which the MU is deployed, the hospital's
wireless environment must be assessed. The parameters to be determined are:
• wireless frequency band (accepted from the local network environment) - default configuration is 5 GHz
Record useable wireless LAN frequency band: __________ GHz
• wireless LAN channel (free or less used channel in the local network environment) - default configuration
is channel (44)
Record useable wireless LAN frequency channel: __________
• unique SSID separated for this Mobile Unit - default is for example "Mobilett Elara_ Serial_No."
Record useable wireless LAN SSID: __________
• Country
Record Country: __________
• Wireless LAN transmission power (field strength) - should be ≤ 17 dBm any place where the Mobile Unit
is used
Record lowest transmission power (field strength): __________ dBm
If the determined WLAN parameters of the local environment deviate from the factory default values
for the MU, the parameters of the access point must be adjusted.
If the required minimum wireless LAN transmission power (field strength) of ≤ 17 dBm cannot be
achieved at all locations where the mobile unit is used, appropriate changes in the hospital area must be
coordinated with the local administration in order to ensure trouble-free operation.
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The wireless hospital environment parameters have been determined.
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11 Portable detector
11.2
Start up the Access Point (detector communication)
The Access Point factory parameter may be modified according to the local wireless LAN environment. Proceed
then as follows.
The factory settings of the Access Point can be modified from the "PMS" >> "Detector" >> "Access Point
Configuration" menu of the service software:
• Wireless LAN protocol: 802.11n
• Frequency band: 5 GHz
• Frequency channel: (44)
• SSID: xxxxxx (for example: MOBILETT Impact_Serial No)
• IP address 192.168.37.101
11.2.1
Setting Up Access Point Scalance 774
If necessary, configure the settings of the wireless Access Point to the detector accordingly:
For more information on configuring the Access Point refer to the service document "Configuration;
SCALANCE W774-1 RJ45 / Country List; XPRF-000.843.06.xx.02".
✓ Log in to the local service software
1 From the service software select:
Tune Up >> Detector mark mark Access Point Configuration and click Go.
Fig. 34: Open the Scalance 744 Access Point Configuration menu (1,2,3)
2 Modify default settings according the local network environment:
• Frequency band
(The 5 GHz frequency band is highly recommended. If this frequency band cannot or must not be used,
2.4 GHz can be set. In this case select frequency channel 1, 6, or 11, or as provided by the customer.)
• Frequency channel
• SSID name
• If requested by the local administration, the default WLAN power of 15 dbm can be reduced.
3 Click Save once the parameter has been changed.
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11 Portable detector
4 Close all menus.
5 Restart the Mobile Unit including the imaging system.
Change becomes valid.
6 Register the detector again so that the new parameter for the access point will be applied to the detector.
7 Check that communication with the detector is valid and active.
• Check LED "WLAN" on detector
• Register a patient and perform a test image.
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11.2.2
The WLAN settings (AP type Scalance 744) for the communication of the detector with the Mobile
Unit have been adapted to the network environment of the hospital.
Setting Up Access Point Aruba 303
If necessary, configure the settings of the wireless Access Point to the detector accordingly:
✓ Log in to the local service software
1 From the service software select:
Tune Up >> Detector mark Access Point Configuration.
2 Mark Access Point Configuration and click Select.
3 Click Start Web-IF to open the configuration assistant.
A page will be displayed containing the "Admin Password".
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11 Portable detector
4 Copy the admin password from the page (every time this page is opened the password will be changed).
5 Then click the link Continue to this website (not recommended).
The Aruba login page will be displayed.
6 Log in with admin privileges.
• In “Username” type in: admin
• In “Password”, paste the password that you copied before.
• Click Login to access the web interface.
7 In the menu navigate to Configuration and click Access Point.
8 Click the network to be configured (it turns blue).
9 Click Edit (pencil icon) to configure settings of the Access Point.
10 Select the Radio section to modify parameter:
• -Frequency band
(The 5 GHz frequency band is highly recommended. If this frequency band cannot or must not be
used, 2.4 GHz can be set. In this case select frequency channel 1, 6, or 11, or as provided by the
customer.)
• Frequency channel
• SSID name
• If requested by the local administration, the default WLAN power of 17 dbm can be reduced.
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11 Portable detector
Fig. 35: Example of Access Point configuration menu: Aruba.
11 Click Save once the parameter has been changed.
12 Close all menus.
13 Restart the Mobile Unit including the imaging system.
Change becomes valid.
14 Register the detector again so that the new parameter for the access point will be applied to the detector.
15 Check that communication with the detector is valid and active.
• Check LED "WLAN" on detector
• Register a patient and perform a test image.
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11.3
The WLAN settings (AP type Aruba) for the communication of the detector with the Mobile Unit
have been adapted to the network environment of the hospital.
Register portable detector
All detectors that were not supplied with the Mobile Unit require registration on the Mobile Unit.
Maximum number of mobile detectors:
• 1 Max wi-D
• 1 Max wi-D for free exposure.
• 1 Max mini wi-D.
✓ The Mobile Unit is switched on.
✓ The detectors that will be used for this Mobile Unit must be switched on and in the case of the "detector
sharing" option, logged off the other system.
✓ If this Mobile Unit was delivered with a detector, the detector is already registered and logged on to the
access point of the Mobile Unit.
✓ The access point of the Mobile Unit has been configured (factory default).
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
11 Portable detector
1 From the UI open the Detector Overview page.
Fig. 36: "Detector Overview" page from the UI
2 Register all detectors used for this Mobile Unit.
• Hold the detector in front of the infrared interface.
• Select the correct detector type and press the “Yes” button.
Fig. 37: Detector Attachment
-
11.4
All detectors used for this Mobile Unit have been registered.
Checking the connection and charging process for detectors on the Mobile
Unit
Check the charging function of all the detectors used with this Mobile Unit.
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11 Portable detector
✓ The Mobile Unit is switched on.
✓ The detectors that will be used for this Mobile Unit must be switched on and in the case of the "detector
sharing" option, logged off the other system.
✓ If this Mobile Unit was delivered with a detector, the detector is already registered and logged on to the
access point of the Mobile Unit.
✓ The detector is inserted into the detector compartment of the Mobile Unit.
1 Check the charging function of all the detectors used with this Mobile Unit.
• Check one detector after the other
• Detector battery charging starts as soon the detector is inserted.
• Look at the status LEDs of the detector.
Fig. 38: wi-D LED
(1) On/ off switch of the detector
(2) Indicator for wireless connectivity
-
The detector charging function for all detectors used with the Mobile Unit has been checked.
2 Check if the detector is connected via the Mobile Unit's wireless LAN.
• The status of the WLAN can be seen on detector status LEDs.
• The status of the WLAN can be seen on the UI Detector Overview.
Refer to further information below.
-
The wireless LAN connection of the Mobile Unit to the detector has been checked.
Meaning of the power On/ Off indicator:
• Green: Detector is ready.
• Red: Detector is not ready.
• Off: Detector is switched off.
• Flashing: boot phase
or error if flashing does not stop
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11 Portable detector
Meaning of the WLAN status LED:
• Green: Wi-Fi status is OK.
• Red: Wi-Fi not ready.
• Off: Wi-Fi switched off.
Meaning of the Battery status LED:
• Green: Battery is OK (>20% *).
• Red: The battery is not completely charged.
• Rapid flashing red: Battery is discharged.
• Off: No battery inserted or battery defective.
A status on the service software screen “Detector Overview” for registered detectors is as follows:
Fig. 39: Detector overview FL-C
The following information will be displayed from the last detector that was connected to the Mobile Unit:
• Detector Type displayed with serial number
• Battery displays the detector battery charge status, e.g., as “fully charged”.
• WLAN connectivity indicated as “full signal”
• “Free indicates that the detector is ready for examination.
• Calibration due indicates when the next calibration must be performed.
• Firmware indicates the actual firmware version of the detector.
Using the “Disconnect” button the detector may be detached from the Mobile Unit.
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12 Detector Calibration
12 Detector Calibration
Calibration must be performed for each detector to be used with the Mobile Unit.
If the Mobile Unit is supplied with a detector, the detector is already matched to the Mobile Unit, calibrated,
and the clinical exposure index and sensitivity factor are determined and configured within the service
software.
If necessary, if the factory calibration was months ago, it is recommended to repeat the calibration. Detectors
shared with other systems must be calibrated during the startup procedure and the clinical exposure index
and sensitivity factor determined.
Calibrating a detector takes about one hour. For each detector to be calibrated, check the state of charge
of the detector battery to see whether the power is sufficient.
Calibration can only be performed if the detector warm-up time of 15 minutes has elapsed.
If the temperature difference between the detector and the ambient temperature is very high (more than
10°C), start the calibration only after the detector has acclimated to the ambient conditions.
Do not place any lead markers on the detector unit or any object between the detector unit and the X-ray
tube. Otherwise, the object will appear later on all images.
The results of checks must be recorded in the Startup - Report.
✓ Temperature in the room when performing calibration should be about the same as during ordinary
acquisitions. Otherwise, you will not obtain images of uniform quality later (temperature 18° - 28°C, relative
humidity < 75%).
✓ The base system batteries must be fully charged because the calibration procedure is performed in battery
mode.
✓ The detector battery charge level is sufficient.
✓ The USB keyboard is connected to the USB port of the Mobile Unit.
✓ The required detector(s) are on hand and registered on the Mobile Unit.
✓ The detector for calibration is connected via the WLAN - check WLAN indication on detector (three LEDs
are all lit up green).
✓
Radiation protection requirements are fulfilled to release radiation.
✓ The detector surface must be clean.
✓ Copper filter 0.6 mm ready to use.
✓ The service software >> FL-C >> Tune-Up >> FD Calibration is opened.
1 Using the support arm, position the X-ray tube parallel to a tabletop, for example, and set an SID of 150
cm (parallel and no grid attached).
2 Open the collimator enough (use the collimator light) so that the light field extends beyond the detector
surface by about 3 cm on each side.
3 Insert the 0.6 mm copper filter into the collimator rail.
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12 Detector Calibration
4 Press the SERV button in the Storage Compartment on the back of the Mobile Unit so that the SERV and
TRANS buttons are activated.
• The kV and mAs display segments in the control and display panel show "SERV DCAL".
Fig. 40: Serv and Trans button are activated
5 From the FD Calibration menu, click Load Temperature Matrix and verify that the required conditions are
met. Confirm by clicking OK.
If necessary, wait until the detector reaches the temperature required (indicated by a green check mark
in the calibration dialog box).
6 Click Next. Select the calibration modes where you see "not calibrated“ and tap Go. Confirm you have
inserted the copper filter required with OK. Comply with the safety instructions; ensure that no one else
is in the room. Start the calibration procedure with OK.
• Select the calibration modes where you see "not calibrated“ and click Go to start the FD Calibration
sequence.
7 Confirm you have inserted the copper filter required with OK.
8 Comply with the safety instructions; ensure that no one else is in the room.
Start the calibration procedure with OK.
9
Before starting the calibration, make sure that radiation protection is observed and that there are no
people in the area.
• The Mobile Unit now performs the selected calibration mode automatically, and releases radiation
repeatedly during the course of the procedure.
• The screen shows the percent progress for the individual calibration mode.
• If the calibration dialog box is hidden temporarily during the procedure, tap the Service task card to
return it to the foreground.
• Confirm with OK to save the newly calculated calibration parameters and use them permanently.
-
The detector calibration has been performed.
10 End service mode once you have successfully saved the data.
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12 Detector Calibration
11 To deactivate, press the SERV button in the Storage Compartment on the back of the Mobile Unit again so
that only the TRANS button is active.
•
The SERV button must be deactivated for normal operation; otherwise, radiation cannot be
released.
Fig. 41: Serv and Trans button when service is deactivated
12 Remove the copper filter and store it in the system documentation binder.
13 Shut down the imaging system and restart it.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
13 Clinical Exposure Index and Sensitivity Factor
13 Clinical Exposure Index and Sensitivity
Factor
For each detector used on a Mobile Unit, the clinical exposure index and sensitivity factor (EXI values) must
be determined.
When a Mobile Unit comes from production together with a detector, these parameters (EXI values) are
already configured.
For detectors that are used via "Shared detectors", the X values must be determined for the first time.
The results of checks must be recorded in the Startup - Report.
✓ The USB keyboard is connected to the USB port of the Mobile Unit computer.
✓ The required detector(s) are on hand and registered on the Mobile Unit.
✓ The detector for determining the Clinical Exposure Index and Sensitivity Factor is connected via the WLAN
- check WLAN indication on detector (three LEDs are all lit up green).
✓ The detector has recently been calibrated.
✓
Radiation protection requirements are fulfilled to release radiation.
✓ The detector surface must be clean.
✓ Copper filter 0.6 mm ready to use.
1 Make sure that the UI shows the physical EXI and clinical EXI values in an exposed image.
• From the UI click the Settings tab and then User Settings.
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13 Clinical Exposure Index and Sensitivity Factor
Fig. 42: Tab Card Settings in the UI
• Select Image Display Properties.
• Make sure that the Physical EXI and Clinical EXI are checked.
• Confirm with Apply and then exit the window with OK.
Fig. 43: Image Display Properties
2 In the SSW, navigate to < FL-C Service > < Configuration > < RAD FD Image Chain Values >.
3 Select the specific detector via the detector serial number (2) and position (1).
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
13 Clinical Exposure Index and Sensitivity Factor
Fig. 44: Image chain value - choose the active detector (1,2)
4 Set the Exposure Index (clinical and physical) on the detector in question to the value 1.000, save the
value entered with Save, and exit the SSW.
Fig. 45: Image chain value - set Quality Exposure Index to 1.000 (3,4)
5
Make an exposure to reach 2.5 µGy as follows:
An exposure must now be made with the following settings to reach 2.5 µGy:
• Select a patient (e.g., Emergency) and an organ program with 70 kV, 1.2 mAs (the mAs value may be
changed to reach the 2.5 µGy)*.
• Insert the 0.6 mm copper filter into the collimator rail.
• Open the collimator all the way.
• Using the support arm, position the X-ray tube parallel to a tabletop, for example, and set an SID of 115
cm (parallel and no grid attached).
•
Make an exposure and read the displayed EXI value.
If required, repeat steps with other mAs to reach the 2.5 µGy.
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13 Clinical Exposure Index and Sensitivity Factor
*
Using a dose probe on top of the detector to determine the exact mAs for 2.5µGy, be sure to remove the
probe before the system calculates the EXI value.
Fig. 46: Settings for sensitivity factor with free exposure
6 In the SSW, navigate to < FL-C Service > < Configuration > < RAD FD Image Chain Values >.
7 Calculate the clinical exposure index and the sensitivity factor for the detector as follows:.
• The Clinical Exposure Index is calculated:
250 / read out of the physical EXI value.
Enter the calculated value (with two decimal places) in the Clinical Exposure Index box.
• The Sensitivity Factor is calculated:
378.4 / read out physical EXI value.
Enter the calculated value (with two decimal places) in the Sensitivity Factor box.
Fig. 47: Image chain value - enter calculated Sensitivity Factor (5)
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
13 Clinical Exposure Index and Sensitivity Factor
8 The Physical Exposure index remains at 1.000.
9 Save the entries with Save.
10 Select Image Display Properties
• Deselect the Physical EXI checkbox.
• The Clinical EXI checkbox must remain selected.
• Confirm with Apply and then exit the window with OK.
Fig. 48: Image Display Properties
11 Select the Examination Properties icon under User Settings.
• Activate the Dose level option in the Display Dose box.
• Activate the Clinical option in the EXI value for DICOM box.
• Confirm with Apply and then exit the window with OK.
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13 Clinical Exposure Index and Sensitivity Factor
Fig. 49: Examination properties
12 Exit User Settings.
13 Log out of the SSW and reboot the Mobile Unit including the FL-C.
• The detector remains attached to the Mobile Unit.
14 Log in to the SSW and select Backup & Restore > Export wi-D data. Select Export wi-D data, select your
detector type from the list, and from the drop-down menu under “Select Export Medium,” select Flat
Detector.
15 Click Go, the calibration data including Sensitivity Value and Clinical Exposure Index are copied to the
mobile detector.
16 After the data has been successfully transferred, exit the menu, exit the service software, and reboot the
system, including the FL-C.
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Page 62 of 88
The Clinical Exposure Index and the Sensitivity Factor have been calculated and configured in
the FL-C service menu.
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14 Checking the X-ray field/ light field
14 Checking the X-ray field/ light field
✓ The Mobile Unit is ready for examination.
✓ DXR ruler is on hand.
1 Using the support arm, position the X-ray tube parallel to the tabletop and at an SID of 115 cm.
Use the tape measure in the collimator to measure to the top surface of the detector.
2 Place the detector (35 cm x 43 cm or if applicable the 24 X 30) on the tabletop.
3 Switch on the light filed and adjust the light field to 30 x 30 cm on the detector.
4 Place the DXR ruler on the detector starting with the front side.
The radiation marker on DXR is facing the center of the detector.
5 Set 70 kV, 0.5 mAs.
6 Switch on the light field. Align the DXR with its marker (light field) to the edge of the light field.
The red mark on the ruler usually represents 0 on a scale and should be aligned with the edge of the
light field from the collimator.
Fig. 50: Place the DXR ruler at all four positions, one at a time
7
Make an exposure.
Fig. 51: X-ray image of the Unfors DXR
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14 Checking the X-ray field/ light field
8 Read the value (VXR_Pos_1) displayed on the DXR and record the value.
• Record VXR:Pos_1 = _______
• Calculate APos_1 = VXR_Pos_1 - VLF
• Record APos_1 = _______
9 Repeat steps on edges on detector for position: For the DXR on right
• Record VXR:Pos_2 = _______
• Calculate APos_2 = VXR_Pos_2 - VLF
• Record APos_2 = _______
10 Repeat steps on edges on detector for position: For the DXR on rear
• Record VXR:Pos_3 = _______
• Calculate APos_3 = VXR_Pos_3 - VLF
• Record APos_3 = _______
11 Repeat steps on edges on detector for position: For the DXR on left
• Record VXR:Pos_4 = _______
• Calculate APos_4 = VXR_Pos_4 - VLF
• Record APos_4 = _______
12 Calculate the deviation DA "X-ray field to light field on front + rear" = (APos_1 + APos_3) * 100%/ SID.
• Record DA = _______
Fig. 52: Light-to-radiation field
Q Deviation D " X-ray field to light field on front + rear" has been checked and is below 1.7 %.
13 Calculate the deviation DA X-ray field to light field (right and left side) = (APos_2+ APos_4) * 100%/ SID
• Record DA = _______
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14 Checking the X-ray field/ light field
Fig. 53: Light-to-radiation field
Q Deviation D " X-ray field to light field on right + left side" has been checked and is below 1.7 %.
14 Check the deviation between the X-ray field and the light field in the positions when the collimator is rotated
to +90° and -90°.
• The deviation should be the same for both positions +/- 90°.
Q the deviation between the X-ray field and the light field in the positions when the collimator is
rotated to +90° and -90° has been checked.
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15 Remote control (option)
15 Remote control (option)
If the RC option is present, install the remote control hand part as follows.
The receiver board D888 is already installed in this case.
Otherwise this chapter can be skipped.
1 Insert the batteries into the remote control and install the remote control bracket either on the support
arm or under the arm handle on the right side.
The remote control and holder have to be marked with the labels provided.
Fig. 54: Remote control locations and identification label
2 If more than one Mobile Unit is active in the same area, the sending and receiving address should be
different for each device.
• The address is changed via dip switches in the remote control hand part and the D888b receiver board
in the device.
• On Mobilett Elara, the current address can be read out in the Service Software.
For changing the communication address:
• Open the lower arm cover of the X-ray support arm.
• Open the remote control hand part.
• Change dip switches 1, 2, and 3 for a unique address.
Dip switch 4 is used to switch off/on the beep.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
15 Remote control (option)
Fig. 55: Setting the DIP switches of the RC hand unit
Fig. 56: Remote control dip switches of the remote control hand part and receiver board D888b.
• Refer to the to the service software section for more information, if necessary.
Tune Up >> Local Generator Tools >> Configuration Settings.
Fig. 57: Read out the configured remote control address.
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16 Checking the “X-ray on” warning indicators
16 Checking the “X-ray on” warning
indicators
The results of checks must be recorded in the Startup - Report as well as in the Safety checks according
to IEC 62353 - Report XPR8-000.333.01.xx.xx.
◆ Check the "X-ray on" indicator during release of radiation.
• Set 81 kV and 10 mAs.
• Ensure that radiation protection is in place before releasing radiation.
•
Make an exposure.
The radiation indicator lights up during the exposure.
An acoustic signal sounds.
Q The "X-ray on" indicator during release of radiation has been tested.
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
17 Pending hotfixes
17 Pending hotfixes
If remote connectivity is active, pending hotfixes are automatically pushed to the Mobile Unit.
If a related pop-up window appears, this current hot fix must be installed.
The results of checks must be recorded in the Startup - Report.
✓ Remote connectivity to the SRS backend is active.
◆ Check if there are any pending hotfixes or updates for the Mobile Unit.
Pending hotfixes/ updates
• are displayed via a pop-up, or
• are displayed when the Mobile Unit is restarted
• If any hot fixes or updates appear, install them.
-
Pending hotfixes or updates have been installed.
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18 Country-specific tests (accuracy tests)
18 Country-specific tests (accuracy tests)
Some countries may require additional accuracy tests, for example, systems in the USA.
• kV accuracy
• mAs accuracy
• Reproducibility test (Dose)
18.1
Test of kV accuracy
AL filtration information of the Mobile Unit:
• Collimator: ≥ 1.6 mm Al (at 75 kVp)
• Tube housing assembly: ≥ 2.25 mm Al (at 75 kVp)
• Total filtration: ≥ 3.85 mm Al, as specified in IEC 60522:1999
If a DAP measurement chamber is installed, the inherent filtration is increased by 0.4 mm Al.
kV meter
Selection
DC voltage
Exposure parameters
Tolerance values [kV]
52 kV
50 mAs
49.0 - 55.0 kV
81 kV
20 mAs
77.0 - 85.0 kV
133 kV
12.5 mAs
126.4 - 139.6 kV
Tab. 5: Table for permissible measured tolerance values for certain set kV values
✓ The Mobile Unit is ready for examination.
1 Using the support arm, position the X-ray tube parallel to the tabletop and set an SID of 100 cm (or set the
SID according to the measurement device instructions).
2 Place the detector (for example, 35 cm x 43 cm) on the tabletop.
3 Place the sensor of the kV meter on the detector surface.
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18 Country-specific tests (accuracy tests)
Fig. 58: kV measuring
4 Switch on the light field and adjust it, for example, to 30 x 30 cm, on the detector.
5 Set 52 kV and 50 mAs.
6
Make an exposure.
7 Check that for 52 kV, the measured kV values are within the tolerance of 49.0 - 55.0 kV.
Q The kV for the set 52 kV has been measured.
8 Set 81 kV and 20 mAs.
9
Make an exposure.
10 Check that for 81 kV, the measured kV values are within the tolerance of 77.0 - 85.0 kV.
Q The kV for the set 81 kV has been measured.
11 Set 133 kV and 12.5 mAs.
12
Make an exposure.
13 Check that for 133 kV, the measured kV values are within the tolerance of 126.4 - 139.6 kV.
Q The kV for the set 133 kV has been measured.
18.2
Test of mAs accuracy
Exposure parameters
Tolerance values [mAs]
40 kV
5 mAs
4.7 - 5.3 mAs
81 kV
2 mAs
1.9 - 2.1 mAs
133 kV
10 mAs
9.5 - 10.5 mAs
Tab. 6: Table for permissible measured tolerance values for certain set mAs values
✓ The Mobile Unit is ready for examination.
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18 Country-specific tests (accuracy tests)
✓ A mAs meter is available
1 Remove the cover from the single tank and connect the mAs meter to D907 (jumper needs to be removed).
Fig. 59: mAs jumper
2 Using the support arm, position the X-ray tube parallel to the tabletop and at an SID of 100 cm
3 Place the detector (for example, 35 cm x 43 cm) on the tabletop.
4 Switch on the light field and adjust the light field to full on the detector.
5 Set 40 kV and 5 mAs.
6
Make an exposure.
7 Check that for 5 mAs, the measured mAs values are within the tolerance of 4.7 - 5.3 mAs.
Q The mAs for the set 5 mAs has been measured.
8 Set 81 kV and 2 mAs.
9
Make an exposure.
10 Check that for 2 mAs, the measured mAs values are within the tolerance of 1.9 - 2.1 mAs.
Q The mAs for the set 2 mAs has been measured.
11 Set 133 kV and 10 mAs.
12
Make an exposure.
13 Check that for 10 mAs, the measured mAs values are within the tolerance of 9.5 - 10.5 mAs.
Q The mAs for the set 10 mAs has been measured.
14 Remove the mAs meter, install the jumper, and install the single tank cover.
18.3
Reproducibility test
In the following test, 10 sequential exposures are taken within one hour.
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18 Country-specific tests (accuracy tests)
Abbreviation and terms:
• C = Coefficient of variation (must be ≤ 0.045)
• S = Standard deviation resulting from the measurements
• X– = Average dose over the measured dose values
• Xi 1...= each measured dose value ( 1... 10)
• n = Number of exposure
✓ The Mobile Unit is ready for examination.
✓ A dose meter is available.
1 Using the support arm, position the X-ray tube parallel to the tabletop and set an SID of 100 cm (or set the
SID according to the measurement device instructions).
2 Place the detector (for example, 35 cm x 43 cm) on the tabletop.
3 Place the sensor of the dose meter on the detector surface.
Fig. 60: kV measuring
4 Switch on the light field and adjust it, for example, to 30 x 30 cm, on the detector.
5 Set 85 kV and 10 mAs.
6
Make 10 exposures, one after the other, and record each measured dose value in a list.
• Resetting the dose meter prior to the next measurement may be required.
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18 Country-specific tests (accuracy tests)
7 Set 81 kV and 20 mAs.
8 Calculate the Coefficient of variation C (based on all measured dose values (10)) according to the
following formula:
9 Ensure that the coefficient of variation C does not exceed 0.045.
Q The coefficient of variation C has been checked.
Coefficient of variation C: ≤0.045
10 Example for determining coefficient of variation C:
• ∑ = 1.01 + 1.02 + 1.03 + 1.04 + 1.03 + 1.02 + 1.02 + 1.01 + 1.03 + 1.04 = 10.25
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18 Country-specific tests (accuracy tests)
• In this example, the Coefficient of variation C complies with the specification: C = 0.0105, which is ≤
0.0450.
Number of Exposure (n=10)
Example of measured dose values (xi1-10) [mGy]
1
1.01
2
1.02
3
1.03
4
1.04
5
1.03
6
1.02
7
1.02
8
1.01
9
1.03
10
1.04
Tab. 7: Example values of the 10 exposures and their dose values
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19 Quality Tests
19 Quality Tests
The results of checks must be recorded in the Startup - Report.
1 Perform the IQAP - test
Via the SSW >> Quality Assurance/ New > “Available Inspections”
• perform the Handover test,
• if additional components were added to the Mobile Unit during startup, such as a common detector or
a grid, also run the Particle test in the IQAP menu accordingly.
Fig. 61: IQAP Test
Q The IQAP for maintenance has been performed.
2 Additional quality tests
If required perform the country-specific acceptance tests.
• Acceptance test according to the country X-ray Ordinance
Tests according to StrlSchV § 115 (§16) of the X-ray Ordinance must be performed in Germany.
In the US, tests must be performed in accordance with the DHHS (country-specific tests (accuracy
tests)). Refer to previous section.
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Country-specific acceptance tests have been performed
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
20 System Backup
20 System Backup
When delivered from the factory, the mobile unit is already prepared with the 2nd HDD, the COBR boot partition
is created, and the service partition "Z:" is available to store service-relevant data on it.
The service partition is used, for example, to store the site-specific configuration files of the imaging system
(FL-C) and the generator module.
Once the entire mobile unit is set up and configured after the startup procedure, the following backups must
be performed:
• Backup of the generator module
• Backup of the site specific configuration
• Creating a Recovery Image of the System Partition
✓
20.1
The results of checks must be recorded in the Startup - Report.
Back up the generator configuration
✓ The service software >> FL-C >> Tune-Up” >> Local Generator Tools is open.
1 Select Unit Configuration Settings.
2 Press the SERV button in the Storage Compartment on the back of the Mobile Unit so that the SERV and
TRANS buttons are activated.
Fig. 62: Serv and Trans button are activated
3 Click Save to File to create a generator backup file of the generator with generator-specific settings.
A new unique backup file will be created in C: AddOn/MobGen/Settings.
The backup file can be read as a .txt file.
The button Board Prog from a SettFile can be used to restore the saved backup files to the Mobile Unit
from the path described above.
-
The generator backup of the generator-specific settings file has been created.
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20 System Backup
The SERV button must be deactivated for normal operation; otherwise, radiation cannot be released.
4
Fig. 63: Serv and Trans button when service is deactivated
5 Go back to Home.
20.2
Backup the FL-C configuration
✓ The service software >> Backup & Restore is open.
1 Select Local under “Select Backup Medium.
• Preferably use the service partition Z:.
2 Click Go to create a backup file of the FL-C with Mobile Unit specific settings.
A new unique backup file will be created.
-
The FL-C backup of the Mobile Unit specific settings has been created.
3 Go back to Home.
20.3
Creating a recovery image of the system partition
Boot-up takes approximately two minutes.
Be patient; do not touch the keyboard or mouse during this time.
Wait until the “COBR - Main Menu” screen appears.
In rare cases the FL-C may boot instead of the COBR application.
Remedy: restart.
✓ The keyboard is connected to the USB port of the Mobile Unit.
1 Switch the Mobile Unit on.
2 Press the <F12> key of the keyboard several times while the FL-C computer reboots.
The boot menu appears.
A pop-up appears prompting the user to enter the BIOS password.
3 Enter the required BIOS password and press the Enter key of the keyboard.
The boot manager is displayed with the available boot partitions of the computer.
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System | Startup Instructions
Print No. XPR8-280.815.01.02.02, Revision date: 04.23
20 System Backup
4 Select <P1:...> / <SATA 1: ...> or <SATA SM: ...> in the Boot menu that follows using the down arrow key.
5 Press the Return key of the keyboard to confirm.
The computer will now boot from the COBR application from the 2nd HDD.
This will take approx. two minutes.
In rare cases the FL-C may boot up instead of the COBR application. Remedy: start over.
6 Create the FL-C backup of the Mobile Unit as follows:
In the COBR Select Workflow menu,
• Select the Backup and click the OK button.
Fig. 64: COBR - Select Workflow menu
• Choose Service Partition as the target volume and click the OK button.
Recovery image creation will start.
Image creation takes about five minutes.
Fig. 65: COBR - Select target device
• When the creation of the recovery image is complete, the following message appears: Backup of the
FL-C partition is finished successfully. Click OK to confirm.
Another popup is displayed.
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20 System Backup
Fig. 66: COBR - Backup progress/success
• Click Yes to Exit the COBR.
The computer will be rebooted. The default UI application is displayed.
The created recovery image can be found on the Z: partition.
Fig. 67: COBR - Exit
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The COBR recovery image has been created.
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System | Startup Instructions
Print No. XPR8-280.815.01.02.02, Revision date: 04.23
21 Option: Wipe dispenser
21 Option: Wipe dispenser
The results of checks must be recorded in the Startup - Report.
◆ Install the wipe dispenser (option) on the top cover as follows:
• Remove the two screws from the top cover.
Fig. 68: Wipe dispenser
• Position the wipe dispenser holder on the top cover.
• Secure the wipe dispenser holder with the longer screws (Fastening material is included).
• Insert the caps in the screw holes.
• Move the arm in various directions to ensure that all movements can be carried.
-
The wipe dispenser has been installed.
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22 Country-specific labeling
22 Country-specific labeling
Some labels are supplied in multiple languages. Attach the label with the appropriate language as indicated
in the Mobile Unit user manual.
The results of checks must be recorded in the Startup - Report.
◆ Attach the following labels to the appropriate position of the Mobile Unit.
The correct position is given in the user manual of the Mobile Unit.
• Warning label This X-ray unit may be dangerous....
• Danger label Explosion hazard....
• For Germany: Control area 1.5 m, 2.5 m or 3.5 m
Label selected by the operator. Affix it to the bottom of the arm.
Fig. 69: Distance label
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The country-specific labels have been attached.
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System | Startup Instructions
Print No. XPR8-280.815.01.02.02, Revision date: 04.23
23 Safety checks according IEC 62353
23 Safety checks according IEC 62353
The results of checks must be recorded in the Maintenance - Report or Startup - Report as well as in
the Safety checks according to IEC 62353 - Report XPR8-000.833.01.xx.xx.
✓ Perform safety checks following the Safety checks according to IEC 62353 instructions,
XPR8-000.833.01.xx.xx.
1 Perform the ground conductor measurement (protective ground resistance) for the Mobile Unit as
specified in the document Safety checks according to IEC 62353 (XPR8-000.833.01.xx.xx).
• Switch off the Mobile Unit .
• Check the protective ground resistance of the Mobile Unit power cord between the protective connection
(ground) and various touchable parts of the Mobile Unit .
Covers over components or parts with 24 V or less are not affected.
S
The grounding conductor measurement for the Mobile Unit has been performed.
2 Perform the device leakage current measurement for the Mobile Unit following the Safety checks
according to IEC 62353:2014-09 (XPR8-000.833.01.xx.xx) document.
S
The device leakage current measurement for the Mobile Unit has been performed.
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24 Final Work Steps
24 Final Work Steps
The results of checks must be recorded in the Startup - Report.
1 Check Mobile Unit operational readiness after completing the startup work.
• Ensure that the SERV button is off and no other service functions are active (e.g.: BSL button or BIOS boot)
• Switch the Mobile Unit off and then on again.
• Make sure that the "service switch active" operator message is not displayed on screen.
• Make sure that release of radiation can be performed.
Q After completion of the startup work, the Mobile Unit has been checked for operational
readiness.
2 Verify that reports are filled out and archived.
• File reports locally in the service binder.
• Send reports back to the factory.
-
Reports have been filled out and archived.
3 Clean the Mobile Unit and detector(s).
• If necessary, clean the Mobile Unit and components or parts after startup work.
• For more information regarding cleaning refer to the Users Manual.
• If necessary, repair or retouch with color spray any damage to painted surfaces.
Q The Mobile Unit has been cleaned.
4 Hand over the Mobile Unit to the customer.
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The Mobile Unit has been handed over to the customer.
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System | Startup Instructions
Print No. XPR8-280.815.01.02.02, Revision date: 04.23
25 Measuring Equipment and Measuring Instruments Used
25 Measuring Equipment and Measuring
Instruments Used
1
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
-
Enter Measuring Equipment incl. Serial Number
2
3
4
5
6
7
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26 Finalize Startup Report
26 Finalize Startup Report
1 Verify startup was done according to technical documents
-
I hereby verify: Performance of startup according to the technical documents provided by the
manufacturer.
2 Verify that all required measurements are within tolerance
-
I hereby verify: Performance of all required measurements; the values are within the tolerance
range of the manufacturer's specifications.
3 Verify completion of all safety and function tests
-
I hereby verify: Successful completion of all safety and function tests and their documentation
in the certificate.
4 Signature on Startup Report
-
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Document completely filled out
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System | Startup Instructions
Print No. XPR8-280.815.01.02.02, Revision date: 04.23
27 Changes to Previous Version
27 Changes to Previous Version
Version <02> compared to version <01>
Chapter
Changes
25 "Measuring Equipment and
Measuring Instruments Used"
Chapter added.
26 "Finalize Startup Report"
Chapter added.
1.7 "Required Documents"
This section has been changed:
• Reference to IEC 62353 report corrected
4 "Connection voltage, line power
adapter, and fuse"
6 "Power ON/OFF/ Lock function
and battery-charging mode"
This section has been changed:
• Reference to IEC 62353 report corrected
This section has been changed:
• Reference to IEC 62353 report corrected
8 "Checking the X-ray tube support This section has been changed:
arm and components"
• Reference to IEC 62353 report corrected
9 "Checking the Emergency Stop
function"
This section has been changed:
16 "Checking the “X-ray on” warn‐
ing indicators"
This section has been changed:
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Print No. XPR8-280.815.01.02.02, Revision date: 04.23
• Reference to IEC 62353 report corrected
• Reference to IEC 62353 report corrected
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services on Siemens Healthcare Products. Any document in electronic
form may be printed once. Copy and distribution of electronic
documents and hard copies is prohibited. Offenders will be liable for
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Print No. XPR8-280.815.01.02.02 / Replaces: XPR8-280.815.01.01.02
Date of first issue: 2022 / Revision date: 04.23 / © Siemens Healthineers