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Philips Healthcare

BV Family Release 2.3


Software Release 2.5.x

AIAT Manual
Level 0 documentation

This document and the information contained in it is proprietary and confidential information of Philips Healthcare
("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disse-
minated without the prior written permission of the Philips Legal Department. This document is intended to be (a.)
used by customers and is licensed to them as part of their Philips equipment purchase or (b.) used to meet regu-
latory commitments as required by a FDA under 21 CFR 1020.30 (and any amendments to it) and other local reg-
ulatory requirements. Use of this document by unauthorized persons is strictly prohibited.
ATTENTION: This page contains copyrighted materials that are confidential and/or proprietary. Any release or distribution of this material,
without permission, is a violation of law.
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DMR117108 Rev:03
BV Family Release 2.3

Proprietary Notice:

This document and the information contained in it is proprietary and confidential information of Philips Healthcare
("Philips") and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disse-
minated without the prior written permission of the Philips Legal Department. Use of this document and the infor-
mation contained in it is strictly reserved for current Philips personnel and Philips customers who have a current
and valid license from Philips for use by the customer’s designated in-house service employee on equipment lo-
cated at the customer’s designated site. Use of this document by unauthorized persons is strictly prohibited. Re-
port violation of these requirements to the Philips Legal Department. This document must be returned to Philips
when the user is no longer licensed and in any event upon Philips’ first written request.

Warranty Disclaimer Language:

Philips provides this DOCUMENT without warranty of any kind, implied or expressed, including, but not limited to,
the implied warranties of merchantability and fitness for a particular purpose.

Limitations of Liability Language:

Philips has taken care to ensure the accuracy of this document. However, Philips assumes no liability for errors or
omissions and reserves the right to make changes without further notice to any products herein to improve reliabil-
ity, function, or design. Philips may make improvements or changes in the product(s) or program(s) described in
this document at any time.

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BV Family Release 2.3

AIAT MANUAL

Contents

1 Introduction ................................................................................................................... ....... 7


1.1 Document history .......................................................................................................................... ......... 7
1.2 Intended use of this manual .......................................................................................................... ......... 7
1.3 Applicable systems ....................................................................................................................... ......... 7
1.4 Certifiable components ................................................................................................................. ......... 7
1.5 AIAT workflow ............................................................................................................................... ......... 7
1.6 Tools ............................................................................................................................................. ......... 9
1.6.1 Standard Toolkit ..................................................................................................................... 9
1.6.2 Measurement tools .............................................................................................................. 10
1.7 Service PC .................................................................................................................................... ....... 11
1.7.1 Introduction .......................................................................................................................... 11
1.7.2 Requirements of the service PC .......................................................................................... 11
1.7.3 Connecting the service PC to the BV Family system ........................................................... 11
1.7.4 Configuring a service connection with an Ethernet cable .................................................... 12
1.7.5 Preparing the service PC for BV-Scope ............................................................................... 12
1.8 Contact .......................................................................................................................................... ....... 15
1.9 Feedback on this document .......................................................................................................... ....... 15

2 Safety ............................................................................................................................ ..... 16


2.1 Important safety directions ............................................................................................................ ....... 16
2.2 Safety instructions ......................................................................................................................... ....... 16

3 Assembly ...................................................................................................................... ..... 26


3.1 Definition ....................................................................................................................................... ....... 26
3.2 Introduction ................................................................................................................................... ....... 26
3.3 Replacement guidances ............................................................................................................... ....... 26
3.3.1 Guidance HF generator replacement BV Pulsera ................................................................ 27
3.3.2 Guidance X-ray tank replacement ....................................................................................... 28
3.3.3 Guidance collimator replacement ........................................................................................ 29
3.3.4 Guidance LAT (collimator) replacement .............................................................................. 29
3.3.5 Guidance LAT (II) replacement ............................................................................................ 30

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3.3.6 Guidance LAT (3D-RX) replacement ................................................................................... 30


3.3.7 Guidance Image Detection Subsystem component replacement ........................................ 30
3.3.8 Guidance SCPU replacement .............................................................................................. 33
3.4 Replacement procedures .............................................................................................................. ....... 35
3.4.1 Replacing the HF generator (BV Pulsera) ........................................................................... 35
3.4.2 Replacing the X-ray tank ...................................................................................................... 36
3.4.3 Replacing the collimator ....................................................................................................... 38
3.4.4 Replacing the LAT (collimator) ............................................................................................. 39
3.4.5 Replacing the LAT (II) .......................................................................................................... 41
3.4.6 Replacing the LAT (3D-RX) ................................................................................................. 46
3.4.7 Replacement of Image Detection Subsystem components ................................................. 47
3.4.8 Replacing the SCPU Unit ..................................................................................................... 63

4 Adjustment .................................................................................................................... ..... 74


4.1 Definition ....................................................................................................................................... ....... 74
4.2 Adjustment and verification procedures ........................................................................................ ....... 74
4.2.1 X-ray tube ............................................................................................................................ 74
4.2.2 Collimator adjustments ........................................................................................................ 84
4.2.3 Laser adjustment and verification ........................................................................................ 87
4.2.4 IDS adjustment .................................................................................................................... 90

5 Testing .......................................................................................................................... ..... 96


5.1 Definition ....................................................................................................................................... ....... 96
5.2 Test procedures ............................................................................................................................ ....... 96
5.2.1 X-ray field verification ........................................................................................................... 96
5.2.2 Dose rate verification ........................................................................................................... 99
5.2.3 Dose indication verification ................................................................................................ 100
5.2.4 X-ray tube performance test .............................................................................................. 101
5.2.5 X-ray tube performance test failed ..................................................................................... 108
5.2.6 Maximum patient entrance dose rate verification .............................................................. 110
5.2.7 Electrical Safety ................................................................................................................. 112

6 Installation ..................................................................................................................... ... 115


6.1 Definition ....................................................................................................................................... ..... 115
6.2 Introduction ................................................................................................................................... ..... 115
6.3 The scope of the checks ............................................................................................................... ..... 115
6.4 Required tools and test equipment ............................................................................................... ..... 115

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6.5 Performance checks ..................................................................................................................... ..... 115


6.5.1 Mechanical checking .......................................................................................................... 115
6.5.2 Functional testing ............................................................................................................... 117
6.5.3 Key test .............................................................................................................................. 118
6.5.4 Laser alignment tool check ................................................................................................ 118

List of Abbreviations ...................................................................................................... ... 121

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BV Family Release 2.3

1 Introduction

1.1 Document history

Status & History of BV Famliy R2.3 AIAT manual


Document ID Reason of change
DMR117108 REV00 Initial release
DMR117108 REV01 New CSA label
DMR117108 REV02 Sections §1.2, §1.7.4.2, §2.2.13, §2.2.14, §5.2.6 and §5.2.7 updated.
Minor text changes in sections §1.5, §1.8 and §6.4.
DMR117108 REV03 Section §1.9 added, section §3.4.3, §5.2.7 updated.

1.2 Intended use of this manual


This manual guides a trained and qualified service engineer in his activities as described in FDA rules
clause 21CFR1020.30(g), regarding Assembly, Installation, Adjustment and Testing (AIAT).
Use the SRM (System Reference Manual) to record the measurement results.

1.3 Applicable systems


This manual is applicable to Philips BV Family R2.3 systems with software release 2.5.x (BV Endura
and BV Pulsera).

1.4 Certifiable components


Certifiable components in the BV Endura 2.3 system are:
• X-ray control
• Tube Housing Assembly
• Beam Limiting Device
• Image Intensifier Assembly
• Spotfilm device
• Laser alignment tool
Certifiable components in the BV Pulsera 2.3 system are:
• X-ray control
• Tube Housing Assembly
• HF Generator
• Beam Limiting Device
• Image Intensifier Assembly
• Spotfilm device
• Laser alignment tool
• Laser alignment tool 3D

1.5 AIAT workflow


Before you start the AIAT workflow, check the general status of the BV Family system.
1. Make sure that the applicable FCOs are implemented.
You can contact the Philips service organization if you do not know whether the applicable FCOs are
implemented.
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2. Ask the customer about the condition of the BV Family system.

Fig. 1: AIAT workflow

AIAT workflow
Step Explanation
Assembly To fit together the parts or pieces of a component or system.
Adjustment To bring various component parts up to a true or more effective relative po-
sition for performance purposes.
Testing A critical examination, observation, or evaluation of such conditions or oper-
ations through testing procedures provided by the manufacturer that will
prove the unit meets specifications.
Installation To set up for use by verifying that proper assembly and adjustments were
made to assure compliance with federal performance specifications.

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BV Family Release 2.3

1.6 Tools
A standard tool kit and additional measurement tools are required for AIAT.

1.6.1 Standard Toolkit


The standard toolkit consists of screwdrivers, Allen keys/spanners, pliers, special appliances and
measuring tools as specified in the following table.

Standard toolkit
Tool Remark
SCREWDRIVERS
Screwdriver (6x): 2.5 mm (0) - 3.5 mm(1) - 4 mm (2) - 5.5mm (3) - 6.5mm(4) -
8mm(5)
Stubby screwdriver (2x): 5.5mm (3) – 8mm (5)
Screw holder slot: No. 2
Crosshead screwdriver: No. 2
Crosshead stubby screwdriver (2x): No. 0 – No. 2
Screw holder crosshead: No. 1
Double end offset screwdriver in line (0° 4mm (2) – 6.5mm (4)
and 90°) (2x):
Watchmakers screwdriver set (6): 0.6–2.5mm
Parallel hexagon driver: 2.5mm
Ball head hexagon driver (4x): 3mm – 4mm – 5mm – 6mm
Torx driver + Torx–bits (10x): T–7 / T–8 / T–9 / T–10 / T–15 / T–20 / T–25 / T–27 / T–30 /
T–40
ALLEN KEYS / SPANNERS
Set hex metric keys (Allen key) (5x): 0.71 – 0.89 – 1.27 – 1.5 – 2mm
Set hex metric keys (Allen key) (8x): 1.5 – 2 – 2.5 – 3 – 4 – 5 – 6 – 8mm
Hex metric key (Allen key) 9mm – 10mm
Set hex inch keys (Allen key) (9x): 1/16 – 3/32 – 1/8 – 5/32 – 3/16 – 7/32 – 1/4 – 5/16 – 3/8”
Combination spanner set (ring/open), 6....22mm in 1mm steps
metric (17x):
Combination spanner set (ring/open), 5mm – 5.5mm
metric (2x):
Combination spanner set (ring/open), 1/4”–7/8” in 1/16” steps
inch (11x):
PLIERS
Long (chain) nose pliers 140 mm
Long-nosed pliers bent 60°
Side cutting pliers
Side cutting pliers small
Water pump pliers 250 mm
Wire stripping pliers
Spring ring pliers: outside / inside
Half-round file (medium grade) + handle
Set of key files (6pcs.)

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Tool Remark
Drill set (19x): 1mm....10mm (steps of 0.5mm)
Masonry drill set (5x): 4 – 5 – 6 – 8 – 10mm
Hammer 200gr. iron
Hammer nylon
Small hacksaw frame
Spare blades for hacksaw (10x): 6”
Cable knife
Scissors
Awl
Pin punch (3x): 1.5mm – 2mm – 4mm
Center punch No. 1
Tap wrench with ratchet No. 1: M3–M10
Hand-machine tap (DIN 352B): M3 – M4 – M5 – M6 – M8 – M10
3/8” drive socket set: 6 – 7 – 8 – 9 – 10 – 11 – 13 – 14 – 17 – 19mm
SPECIAL APPLIANCES
Hollow head potentiometer adjuster 3.2mm diameter
Tweezers
Strong insulated mirror plain (diff. type)
Magnifying glass: 10x
MEASURING TOOLS
Vernier callipers 1/125” – 0.05mm
Extending rule: 3m
Flat precision steel rule: 300mm
Spirit level: 400mm
Plumb bob

1.6.2 Measurement tools


Make sure that the tool accuracy is within specification.

Required measurement tools


Tool Measuring mode Specification
Dosemeter Dose: ± 5% (range 100 nGy-100 mGy)
Doserate: ± 5% (range 100 nGy/s-100 mGy/s)
kVp (non-invasive): ± 2% (range 40-120 kV)
Time: ± 1% (range 30- 10000 ms)
DC multi meter Voltage: ± 0.5% (range 1 - 1000 V, display: 4 digits)
Earth Bonding Tester Protective earth resistance 0....400mΩ
Resolution 1 mΩ
Accuracy 5%
Measuring current 10A (regulated)
Measuring frequency 50Hz or 60Hz (programmable)
Measuring voltage 6V
Supply voltage 110/220Vac 10%, 50/60Hz

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BV Family Release 2.3

Tool Measuring mode Specification


IEC Leakage Current Measuring Mode 0....100mA
Measuring Device Accuracy ± 5%
Resolution 0.1mA
Measuring frequency 0....1kHz
X-ray ruler with 2 mm
scale indication

1.7 Service PC

1.7.1 Introduction
This chapter describes how to configure a connection between the service PC and the BV Family sys-
tem.

NOTICE
Together with a restart of the system, always close BV-Scope via Exit in the main menu and restart it.

1.7.2 Requirements of the service PC


The requirements for the service PC are:
1. Windows XP or Windows7 with administrator rights.
2. Internet Explorer 5.5 or higher (preferred Internet Explorer 8).
3. CD-ROM player.
4. Ethernet-card.
5. Java support.
Before you start BV-Scope, make sure that IST runs on your service PC. Contact your local Philips
representative for more information about IST.

1.7.3 Connecting the service PC to the BV Family system


The service PC can be connected with an Ethernet cable to the BV Family system. See Figure 'Con-
necting the service PC to the BV Family system (ViewForum and DICOM are optional)'.

Fig. 2: Connecting the service PC to the BV Family system


For the necessary configuration of the connection and the preparation of the service PC for BV-Scope,
see the next sections.

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1.7.4 Configuring a service connection with an Ethernet cable


The settings for the network are described for a Windows XP and Windows 7 operating system. To
configure a service connection:

NOTICE
The Network card in the service PC has to communicate with the 10 MB or 100 MB Ethernet connec-
tion of the DFI. Therefore, the communication speed of the network card has to be set at 10 Mbps,
100 Mbps or Auto.

1.7.4.1 Configuring a service connection for Windows XP


1. Start > Settings > Control Panel. The Control Panel window appears.
2. Double click the Network Connections icon. The corresponding window appears.
3. Click with the right mouse button on the Local Area Connection icon. A menu appears.
4. Click |PROPERTIES|. The Local Area Connection Properties window appears.
5. Mark and select Internet Protocol (TCP/IP).
6. Click |PROPERTIES|. The Internet Protocol (TCP/IP) Properties window appears.
7. Select Use the following IP Address.
8. Click |ADVANCED|. The Advanced TCP/IP Settings window appears.
9. Click |ADD| (the upper button). The TCP/IP Address window appears.
10. Enter the IP address (use the Service IP address (see Setup tab on the MVS), change the last digit
group to another number than visible on the MVS, e.g. if the service IP address is 192.168.1.61, enter
the IP address 192.168.1.5. However, do not use the IP address 192.168.1.50).
11. Enter the Subnet mask: 255.255.255.0
12. Click |ADD|. The Advanced TCP/IP Settings window appears.
13. Click |OK|. The Internet Protocol (TCP/IP) Properties window appears.
14. Click |OK|. The Local Area Connection Properties window appears.
15. Click |OK|. The Network Connections window appears.
16. Close the window.

1.7.4.2 Configuring a service connection for Windows 7


1. Start > Control Panel.
2. In category view, select: View network status and tasks.
3. Select: Change adapter settings:
4. Right-click Local Area Connection and select Properties.
5. Select: Internet Protocol Version 4 and click properties.
6. Enter the IP address (use the Service IP address (see Setup tab on the MVS), change the last digit
group to another number than visible on the MVS, e.g. if the service IP address is 192.168.1.61, enter
the IP address 192.168.1.5. However, do not use the IP address 192.168.1.50).
7. Enter the Subnet mask: 255.255.255.0
8. Select: OK and then Close.
9. IP address is set for connecting the Mobile surgery system.

1.7.5 Preparing the service PC for BV-Scope


1.7.5.1 Configuring the Internet Explorer settings
1. Start Internet Explorer.
2. Select Tools > Internet Options. The corresponding window appears.
3. Select the General tab, click in the Browsing History |SETTINGS|.
4. Select Automatically, click |OK|.
5. Select the Security tab, click the Trusted sites icon.

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6. Click |SITES|. The Trusted sites window appears.


7. Unselect Require server verification…
8. In the Add this Web site to the zone field, enter http:// followed by the service IP address visible on
the Setup tab on the MVS.
9. Click |ADD|.
10. Click |CLOSE|. The Security tab appears.
11. Select the Connections tab.
12. Select Never dial a connection.
13. Click |LAN SETTINGS|. The Local Area Network (LAN) Settings window appears.
14. If Use a proxy server for your LAN has been selected, click |ADVANCED|. If not: go to step 17.
15. In the Exception panel, enter the IP address of the MVS.
16. Click |OK|.
17. Close all windows using the |OK| buttons. The entered values will be stored.

1.7.5.2 Configuring the Active-X control settings


1. Start Internet Explorer.
2. Select Tools > Internet Options. The corre-
sponding window appears.
3. Select the Security tab, the corresponding tab
appears.
4. Select (click symbol with text below) Internet
and click Default level .
5. Select (click symbol with text below) Local Inter-
net and click Default level .
6. Select (click symbol with text below) Restricted
sites and click Default level .

Fig. 3: Security settings window (1)

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7. Select (click symbol with text below) Trusted


sites and click Custom level, the corresponding
window appears:
8. Configure the following :
• Allow previously unused ActiveX controls to
run without prompt: Select: Disable
• Automatic prompting for ActiveX controls: Se-
lect: Disable
• Download signed ActiveX controls: Select:
Prompt
• Download unsigned ActiveX controls: Select:
Disable
• Initialize and script ActiveX controls not
marked as safe for scripting: Select: Enable
Fig. 4: Security settings window (2)
• Only allow approved domains to use ActiveX
without prompt: Select: Enable
• Run ActiveX controls and plug-ins: Select: En-
able
• Script ActiveX controls marked safe for script-
ing: Select: Enable

1.7.5.3 Creating a shortcut for BV-Scope


The function of this shortcut is to give quick access to a certain IP address with a certain port number.
At first time use of BV-Scope:
1. Connect a cable between the service PC and the MVS.
2. Power ON the system.
3. In the Setup panel of the MVS select |Enable service|:

Fig. 5: Setup panel (example)

NOTICE
If Enable service has not been selected in the Setup panel of the MVS, BV-Scope will not start and
service is not possible. This function has been added to secure the data.

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4. Start Internet Explorer.


5. In the Address bar, enter: http:// followed by the service IP address visible on the Setup tab on the
MVS followed by: :54670. (for example: http://192.168.1.61:54670)
6. The File Download window appears.
7. Click |SAVE|. The Save As window appears.
8. In the Save as field, select Desktop.
9. In the File name field change the name in: BV-Scope.hta
10. Click |SAVE|. The Download Complete window appears.
11. Click |CLOSE|.
12. Close Internet Explorer.
13. Start BV-Scope with the BV-Scope shortcut on the desktop. The Target Address Confirmation win-
dow appears.
14. Enter the service IP address visible on the Setup tab on the MVS.
15. Click |OK|. BV-Scope will appear with its top-level menu.

1.8 Contact
For more information about this manual, contact the Philips service organization.

1.9 Feedback on this document

1. Log on to the InCenter website.


2. In the Search field, type the DMR number of
this manual.
3. In the User Rating column, in the row with the
title of the manual, click Rate It.
4. If you want to, add a rating to show how much
you like this manual.
• After Add Rating, click a number of stars,
★★★★★ is the highest rating.
5. In the Comments field, type your comments
and your e-mail address to make it possible to
contact you.

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2 Safety
For more information about general safety, see Instructions for Use.

2.1 Important safety directions


Philips Healthcare products are all designed to meet stringent safety standards. However, all medical
electrical equipment requires proper operation and maintenance, particularly with regard to human
safety.
It is vital that you read, note, and where applicable strictly observe all danger notices and safety mark-
ings on the system. It is vital that you follow strictly all safety directions, all warnings and all cautions
that are mentioned in this chapter and throughout the system documentation, to help ensure the safe
servicing and operating of the system, in order to protect the personal health of the FSEs, the opera-
tors and the patients.
In particular, you must read, understand and know the emergency procedures described in this chapter
before attempting to service the system.

Adequate training
Do not service the system until you are adequately and properly trained as a FSE. If you are not suffi-
ciently qualified DO NOT SERVICE THE SYSTEM. Servicing this system without proper and ade-
quate training could lead to fatal or other serious personal injury.

Intended use & compatibility


• Do not use the system for any purpose other than those for which it is intended.
• Do not use the system with any products other than those which Philips Healthcare recognizes as
compatible.
• Servicing or operating the system for unintended purposes, or with incompatible equipment, could
lead to fatal or other serious injury.

For more information about operating the system, please see the Instruction for Use.
When a safety test fails, mark the BV Family system as unsafe.

2.2 Safety instructions

2.2.1 Emergency procedures


In case of emergency, switch the system off.

Fig. 6: Emergency button

• Press the |EMERGENCY| button on the C-arm stand.


• Remove the mains power plug of the mobile viewing station from the socket outlet.

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When the BV Family system is switched off using the |EMERGENCY| button be aware that mains
power is still applied to some circuits in the system until the mains power plug of the mobile viewing
station is removed from the socket outlet.

2.2.2 Electrical safety


The BV Family system contains high power electrical components and must be serviced only by per-
sonnel familiar with its circuitry, operation and potentially dangerous components. You can be fatally
shocked by a discharging capacitor, high voltage cable or battery current, even when the mains power
cord is disconnected.
Dangerous voltages are present in the following areas of the system:
• High voltage generator
• High voltage cable
• X-ray tube assembly
• Image intensifier assembly - 25 000 to 30 000 VAC
• Batteries - max. 405 VDC in case of overcharge
• Mains control unit - 600 VAC
• SCPU-E connector X25 - 450 VAC
For your protection, always observe the following basic safety requirements:
• Follow the instructions and labels, which are attached to several system components.
• Ensure that the voltage and frequency rating of the power socket outlet matches the electrical rating
labels of the system.
• Use properly grounded power socket outlets.

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General electrical safety warnings


• Do not remove covers or cables from the system, unless expressly instructed to do so in this man-
ual. High electrical voltages are present within the system. Removing covers or cables could lead
to serious or fatal personal injury.
• Only use the system in rooms or areas that comply with all applicable laws (or regulations having
the force of law) concerning electrical safety for this type of system.
• Get someone to watch while you work near high voltages. That person must remain clear of all cir-
cuitry and be prepared to turn OFF the system and render aid in case of an emergency.
• Do not touch live parts (e.g. high voltage cables and large electrolytic capacitors) unless the sys-
tem is powered down and the live parts have been de-energized completely. High voltage cables
and large electrolytic capacitors can retain a dangerous static charge for long periods after power
is removed from the system. Large electrolytic capacitors can acquire a charge spontaneously
without contact with other circuitry.
• Remove all metal rings, watchbands and other jewelry before servicing the electrical system. Skin
burns can result when metal jewelry short circuits electrical currents from the system.
• Do not ship system batteries with exposed terminals. Only use factory-supplied shipping containers
that completely cover the terminals with insulating material and are strong enough to contain the
weight of the batteries during rough handling.
• Always first unplug the AC power cord before servicing the power supply.
• Leave the AC power cord connected to the (properly grounded) power socket outlet when servicing
drives, dims, chips or the system board.
• To prevent damage to electronic components from ESD, always wear a wrist strap when handling
drives, PCBs and other sensitive electronic equipment. In addition, use an approved anti-static
(ESD) mat. Try to handle PCBs by their edges and avoid touching electronic components, pins and
contacts.
• Always electrically isolate the system from the mains electrical supply before cleaning, disinfecting
or sterilizing it.
• BV Pulsera only: The battery voltage remains high at all times (310 V - 367 V), even when the
mains cable has been unplugged. Therefore, always disconnect both the mains cable and the bat-
tery cable before servicing the battery. Electric shock from batteries can cause death or personal
injury, including severe burns. Use extreme caution when working on circuits energized by or locat-
ed near the batteries. Batteries are dangerous at all times and cannot be quickly discharged like
capacitors.
• BV Pulsera only: When using an oscilloscope for measurements on the energy storage unit the os-
cilloscope must not be in contact with the mains earth.

2.2.2.1 Equipotential ground connection

This equipment may only be used in areas meeting local standards for electrical safety in rooms used
for medical purposes, for example the US National Electrical Code. IEC 60601 also gives guidance
about an equipotential ground (earth) connection point.
• An equipotential ground (earth) connection point and a connection cable are provided.

2.2.3 Transportation safety


When moving mobile or transportable devices, make sure you do not collide with/or run over objects
and/or persons. The user must be familiar with the brake system and all controls for steering before
moving the equipment.

18 CSIP Level 0 DMR117108 Rev:03


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• Ensure that the system is in the transport position.


• Cross ramps, thresholds and obstacles as slowly as possible. Take extra care on steep slopes.
• Wheel brakes must always be applied when the device is stationary.

2.2.4 Mechanical safety

General mechanical safety warnings


• Switch system power OFF before you remove the covers from the BV Family system.
• Covers or cables should only be removed by qualified and authorized service personnel. In this
context, qualified means ‘those legally permitted to work on this type of medical electrical system in
the jurisdiction(s) in which the system is being used’, and authorized means ‘those authorized by
the user of the system’. Ordinary users should NEVER remove the covers themselves.
• After servicing the system, check for uncontrolled movement of the system when releasing the sys-
tem brakes.
• For BV Pulsera only: Make sure that, when the system is parked and connected to the mains for
recharging, the system lock is in the disabled position and the system lock key is removed to pre-
vent accidental radiation and movements.

2.2.5 Explosion safety


The system must not be serviced in the presence of explosive gases or vapours, such as certain an-
aesthetic gases. Servicing electrical equipment in an environment for which it was not designed can
lead to fire or explosion.

General explosion safety warning


Flammable or potentially explosive disinfecting sprays must not be used, since the resulting vapour
could ignite, causing fatal or other serious personal injury and/or damage to equipment.

2.2.6 Fire safety


Servicing electrical equipment in an environment for which it was not designed can lead to fire or ex-
plosion. Fire regulations for the type of medical area being used, should be fully applied, observed and
enforced. Fire extinguishers should be provided for both electrical and non-electrical fires.

General fire safety warning


Only use extinguishers on electrical or chemical fires which are specifically labelled for those purpos-
es. Using water or other liquids on an electrical fire can lead to fatal or other serious personal injury.

If it is safe to do so, attempt to isolate the equipment from electrical and other supplies before attempt-
ing to fight a fire. This will reduce the risk of electric shocks.

2.2.7 Mobile telephone & similar products


The Philips BV Family system complies with the requirements of applicable EMC standards. Other
electronic equipment exceeding the limits defined in such EMC standards, such as certain mobile tele-
phones, could, under unusual circumstances, affect the operation of the system.

DMR117108 Rev:03 CSIP Level 0 19


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EMC: cell phone radiation warning


Do not allow any portable radio transmitting devices (such as mobile telephones) into the proximity of
the system - whether the device is switched ON or OFF. Such devices could exceed EMC radiation
standards and, under unusual conditions, interfere with the proper functioning of the system. This
could, in extreme cases, lead to fatal or other serious personal injury or to clinical mistreatment when
the system is in use.

2.2.8 Electromagnetic compatibility


The Philips BV Family system complies with the requirements of applicable EMC standards. Emissions
of electromagnetic interference (radiated or conducted) do not exceed permitted levels, and the system
is also resistant to interference from other equipment within these levels. Refer to Instructions for Use,
chapter Technical Data.

EMC: general radiation warning


All surrounding equipment must comply with the EMC standards for emissions and sensitivity to emis-
sions. Equipment which does not comply, may interfere with the proper functioning of the system. This
could, in extreme cases, lead to fatal or other serious personal injury or to clinical mistreatment when
the system is in use.

2.2.9 Radiation safety

X-ray radiation safety warnings


• Only qualified and authorized personnel may operate this equipment. In this context, qualified
means ‘those legally permitted to operate this type of medical electrical system in the jurisdiction(s)
in which the system is being used’, and authorized means ‘those authorized by the user of the sys-
tem’.
• FSEs servicing and users operating the system must observe all laws and regulations which have
the force of law within the jurisdiction(s) concerned. If there is any doubt about these laws and reg-
ulations, it is not allowed to service the system.
• The X-ray tube produces potentially dangerous ionizing X-radiation when it is energized. Never op-
erate the system carelessly or without X-ray shielding in place. Before producing X-ray make sure
that the X-ray shielding of the system, e.g. the X-ray tank cover, is not damaged. Use lead aprons,
eye protection, thyroid protection and other similar devices to protect yourself and others.
• NEVER attempt to remove, modify, override or frustrate any safety device on the system. Interfer-
ing with safety devices could lead to fatal or other serious personal injury.
• BV Pulsera only: Make sure that, when the system is parked and connected to the mains for re-
charging, the system lock is in the disabled position and the system lock key is removed to prevent
accidental radiation and movements.

In addition, users are strongly urged to acquaint themselves with the current recommendations of the
International Commission on Radiological Protection (ICRP), and in the United States, with those of
the US National Council on Radiological Protection (NCRP).
• ICRP, for more information visit: www.icrp.org
• NCRP, for more information visit: www.ncrp.com
Full use must be made of all radiation protection features on the system, and of all radiation protection
devices, accessories, systems and procedures available to the FSE.

20 CSIP Level 0 DMR117108 Rev:03


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2.2.9.1 Radiation guidelines

Use of controls, adjustments or procedures other than those specified in this manual may result in
hazardous radiation exposure.

Try to obey to the following rules when performing radiation:


• Do not radiate when not necessary.
• Radiate for as short a time as possible.
• Use automatic dose rate control whenever possible.
• Stay as far away as possible from the radiated object/X-ray source.
• Wear lead aprons and other protective clothing as appropriate.
• Use badges to monitor the radiation levels received.
• Use LDF as much as possible instead of HDF to reduce dose.
• Collimate as much as possible using the pre-indicators (on the LIH image).
• Focal spot to skin (object) distance should be kept as large as possible to reduce the absorbed dose.
• Remove all supplementary obscuring objects from primary beam (this includes the hands of the user).
• In principle, the X-ray source should be placed under table to reduce scattered radiation resulting in
extra safety for physician and staff.
• Take into account any adverse effects that may arise due to materials located in the X-ray beam, for
example, the operating table.
• The mobile viewing station must be positioned so that the radiation indicator on the mobile viewing sta-
tion is visible to all persons at all positions in the room.

2.2.10 Laser Light radiation safety


The laser lights in the Laser Alignment Tool (LAT), the LAT (II) and 3D laser should only be used under
supervision of a medically trained person with knowledge of the hazards implied by the use of laser
light. It is the responsibility of the FSE to fulfill the local safety regulations regarding laser light radia-
tion.

Laser light radiation safety warnings


• Class II (FDA), do not stare into beam / Class 3R laser (IEC), avoid direct eye exposure.
• The laser must not be switched on without purpose, and unnecessary exposure must be avoided.
• CAUTION: Use of controls or adjustments or performance of procedures other than those specified
herein may result in hazardous radiation exposure.

2.2.11 Safety label positioning


Refer to the Instructions for Use of the BV Family for information about the safety label position.

When a certifiable item is replaced, fit the supplied identification label and the date of the manufactur-
er label of the new certifiable item on the central labelling plate, marked ’Ι ’ on the C-arm stand.

DMR117108 Rev:03 CSIP Level 0 21


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BV Family Release 2.3

2.2.12 Liquids and safety

• Prior to cleaning the system, always unplug the AC power cord from the power socket outlet.
• Only use a dry or lightly damped cloth to clean the system. Prevent any liquids from leaking into
the system where they can cause electric shock, fires and short circuits. If such a leakage does
occur, ensure that the internal circuitry of the system is completely dry before attempting to operate
the system.
• Never store or operate the system in the presence of conductive fluids, like water or saline solu-
tion, unless the system is adequately protected by an approved bagging or draping system. Con-
ductive fluids can leak into unprotected areas, causing electric shock, fires and short circuits.

2.2.13 Unauthorized modifications


When properly assembled, Philips BV Family systems comply with the Federal Performance Stand-
ards for Diagnostic X-ray Systems (21 CFR 1020.30-32), providing that no components or parts are
removed from the system and no unauthorized adjustments are performed on the system.

Never perform unauthorized modifications to the Philips BV Family system. Doing so


could result in death, personal injury or damage to the system.
Never operate the system with any part of the housing or beam limiting device removed.

2.2.14 Labels and symbols


Various safety labels and symbols are located on the Philips BV Family system.

2.2.14.1 Check labels


1. Check the labels and warnings on the C-arm stand and MVS for legibility.

Fig. 7: Location of safety labels BV Endura Fig. 8: Location of safety labels BV Pulsera

No. Description
A Warnings on C-arm console
B Warnings on X-ray tank
C Warning and label on front cover
D Central labeling station
E Warnings on rear side

Warnings on the C-arm stand console (A)


The following warnings are on the C-arm stand console. It is only applicable to the USA, Canada, Chi-
na and Japan.

22 CSIP Level 0 DMR117108 Rev:03


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Label text
This X-ray unit may be dangerous to patient and operator
unless safe exposure factors, operating instructions and
maintenance schedules are observed.

Warnings on the X-ray tank (B)


The following warnings are on the X-ray tank. If an optional LAP laser is present, the labels below are
applicable for this laser too.
Label text
Laser Radiation Laser radiation
Do not stare into beam Avoid direct eye exposure
Max. output < 0.8 mW Max. output < 5 mW
Emitted wavelength 670 nm Emitted wavelength 670 nm
FDA Class II laser product Class 3R laser product (IEC
60825-1 2001-08)
Laser aperture
Laser warning

The following warning is applicable to USA, Canada and Taiwan only.


Label text
WARNING:
This spacer must be installed.
Unless the specific procedure prohibits this.

Label on the front cover of the C-arm stand (C)


The following label is displayed on the front cover of the C-arm stand.
Label text
Labels

DMR117108 Rev:03 CSIP Level 0 23


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Central labelling station (D)


The central labelling station contains the following
information about the certifiable items (DHHS):
• X-ray control
• Image Intensifier
• Beam Limiting Device
• Laser product (optional)
• Tube Housing Assembly
• X-ray tube
• X-ray generator
• Laser Product 3D laser (optional)

The appropriate labels on this panel must be up-


dated when replacing certified components.

Fig. 9: Central labelling station (example)

Warnings and labels on the rear side of the mobile view station (E)
The following warnings and labels are on the rear side of the mobile view station.

Label BV Endura System

Philips type: 718 075


Made in Holland ON: SN:
Philips Medical Systems NL B.V. bar code CE symbol 0344 Prod-
Veenpluis 4-6 5684 PC Best uct disposal symbol
The Netherlands
Read IfU symbol
Mains rat- Frequency Momentary Long term Max Ω
ing
100/110 V~ 50/60 Hz 22*/20* A 15/14 A 0.1/0.2
120/130 V~ 50/60 Hz 47 (20*)/40 13/12 A 0.1/0.2
(18*) A
200/210/220/ 50/60 Hz 25/22 A 7/6 A 0.6
230/240 V~
Single phase *Fluoro only

24 CSIP Level 0 DMR117108 Rev:03


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BV Family Release 2.3

Label BV Pulsera System

Philips type: 718 095


Made in Holland ON: SN:
Philips Medical Systems NL B.V. bar code CE symbol 0344 Prod-
Veenpluis 4-6 5684 PC Best uct disposal symbol
The Netherlands
Read IfU symbol
Mains rat- Frequency Momentary Long term Max Ω
ing
100/110/120/ 50/60 Hz 22/18 A 8/6 A 0.1/0.2
130 V~
200/210/220/ 50/60 Hz 12/10 A 5/4 A 0.6
230/240 V~
Single phase

Label text
Medical Electrical Equipment
Certified according to
CAN/CSA-C22.2 No 60601-1-08 and
ANSI/AAMI ES60601-1:2005

The following warning is applicable to USA and Canada only.


Label text
Grounding reliability can only be achieved when the equip-
ment is connected to a sufficiently grounded power socket.

Label text
Read Instructions for Use symbol

Warning ESD hazard

2.2.14.2 Symbols
For the safety symbols and their positions, refer to the Instructions for Use.

DMR117108 Rev:03 CSIP Level 0 25


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BV Family Release 2.3

3 Assembly

3.1 Definition
To fit together the parts or pieces of a component or system.

3.2 Introduction
According the IEC 62353, clause 5, these tests are defined for recurrent testing (= after re-connecting
an earthwire):
1. Measuring of Protective earth resistance
2. Measuring of Equipment leakage current (Earth leakage current)
3. Measuring of Insulation resistance of mains parts (not mandatory)
For more information, see chapter "Testing".

3.3 Replacement guidances


A guidance is a what-to-do table. The table lists the items below or has references to sections that de-
scribe items below:
• Item to be replaced
• Hardware programming
• Replacement procedure
• Adjustments and verifications
• System verification

26 CSIP Level 0 DMR117108 Rev:03


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BV Family Release 2.3

3.3.1 Guidance HF generator replacement BV Pulsera


Item to Programming Replacement Adjustment & System
replace hardware procedure verification procedure verification
HF generator Program jumper chapter Replacing figure 10 on page 27 Update labeling
according to the the HF generator Fix central labels
local mains (BV Pul-
frequency sera) on page 35
chapter Replacing
the HF generator
(BV Pul-
sera) on page 35

Fig. 10: Flowchart Adjustments and Verifications after HF generator replacement BV Pulsera
*
chapter X-ray tube performance test failed BV Pulsera on page 109 if the X-Ray tube performance
test fails.

DMR117108 Rev:03 CSIP Level 0 27


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BV Family Release 2.3

3.3.2 Guidance X-ray tank replacement


BV Endura
Item to replace Programming hardware Replacement procedure Adjustment & verifi- System verifi-
cation procedure cation
X-ray tank None chapter Replacing the X- figure 11 Update label-
ray tank on page 36 on page 28 ing
Fix central la-
bels

Fig. 11: Flowchart Adjustments and Verifications after X-ray tank replacement BV Endura
*
chapter X-ray tube performance test failed BV Endura on page 108 if the X-Ray tube performance
test fails.

BV Pulsera
Item to replace Programming hardware Replacement procedure Adjustment & verifi- System verifi-
cation procedure cation
X-ray tank None chapter Replacing the X- figure 12 Update label-
ray tank on page 36 on page 29 ing
Fix central la-
bels

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BV Family Release 2.3

Fig. 12: Flowchart Adjustments and Verifications after X-ray tank replacement BV Pulsera
*
chapter X-ray tube performance test failed BV Pulsera on page 109 if the X-Ray tube performance
test fails.

3.3.3 Guidance collimator replacement


Item to Programming Replacement Adjustment & System
replace hardware procedure verification procedure verification
Collimator None chapter Replacing Refer to Collimator ad- Update labeling
assembly the collima- justment & verification: Fix central labels
tor on page 38 • Iris adjustment
Note: Remove the • Shutter adjustment
LAT (collimator) • Iris verification
• Shutter verification
• LAT (optional) adust-
ment

3.3.4 Guidance LAT (collimator) replacement


Item to Programming Replacement Adjustment & System
replace hardware procedure verification procedure verification
Laser Align- None chapter Replacing See chapters Adjust- Update labeling
ment Tool the LAT (collima- ment and Testing: Fix central labels
(collimator) tor) on page 39 • Laser alignment LAT
(collimator)
• Iris adjustment
• Shutter adjustment
• X-ray field verifica-
tion

DMR117108 Rev:03 CSIP Level 0 29


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BV Family Release 2.3

3.3.5 Guidance LAT (II) replacement


Item to Programming Replacement Adjustment & System
replace hardware procedure verification procedure verification
Laser Align- None chapter Replacing chapter Laser adjust- Update labeling
ment Tool (II) the LAT ment LAT (II) Fix central labels
(II) on page 41 on page 89

3.3.6 Guidance LAT (3D-RX) replacement


This section is only applicable to BV Pulsera systems with the 3D-RX option.
Item to Programming hardware Replacement procedure Adjustment & verification System verifi-
replace procedure cation
LAT (3D- None chapter Replacing the None Update label-
RX) LAT (3D- ing and fix
RX) on page 46 central labels.

3.3.7 Guidance Image Detection Subsystem component replacement


Item to Programming hardware Replacement procedure Adjustment & verification System verifi-
replace procedure cation
II Assem- None chapter Replacement of • II focus adjustment Update label-
bly Image Detection Sub- • Camera centering ing and fix
system compo- adjustment central labels.
nents on page 47 • Camera center of ro-
tation adjustment
• II diameter adjust-
ment
• Dose rate adjust-
ment
• Iris adjustment
• Shutter adjustment
• Dose rate verifica-
tion
• X-ray field verifica-
tion
II Power None chapter Replacement of • Dose rate adjust-
supply Image Detection Sub- ment
system compo- • Dose rate verifica-
nents on page 47 tion

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Item to Programming hardware Replacement procedure Adjustment & verification System verifi-
replace procedure cation
II Insert None chapter Replacement of • II focus adjustment
Image Detection Sub- • Camera centering
system compo- adjustment
nents on page 47 • Camera center of ro-
tation adjustment
• II diameter adjust-
ment
• Dose rate adjust-
ment
• Iris adjustment
• Shutter adjustment
• Dose rate verifica-
tion
• X-ray field verifica-
tion
II Hous- None chapter Replacement of • II focus adjustment
ing Image Detection Sub- • Camera centering
system compo- adjustment
nents on page 47 • Camera center of ro-
tation adjustment
• II diameter adjust-
ment
• Dose rate adjust-
ment
• Iris adjustment
• Shutter adjustment
• Dose rate verifica-
tion
• X-ray field verifica-
tion
Camera None chapter Replacement of • II focus adjustment Update label-
Lens Image Detection Sub- • Camera centering ing and fix
Assem- system compo- adjustment central labels.
bly nents on page 47 • Camera center of ro-
tation adjustment
• II diameter adjust-
ment
• Dose rate adjust-
ment
• Iris adjustment
• Shutter adjustment
• Dose rate verifica-
tion
• X-ray field verifica-
tion

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Item to Programming hardware Replacement procedure Adjustment & verification System verifi-
replace procedure cation
Control Make sure that jumber chapter Replacement of • II focus adjustment
board X5 is in NOR position. Image Detection Sub- • Camera centering
system compo- adjustment
nents on page 47 • Camera center of ro-
To install the software tation adjustment
on the control board, • II diameter adjust-
chapter Software instal- ment
lation Control • Dose rate adjust-
Board on page 62 ment
• Iris adjustment
• Shutter adjustment
• Dose rate verifica-
tion
• X-ray field verifica-
tion
Interface None chapter Replacement of None
board Image Detection Sub-
system compo-
nents on page 47

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3.3.8 Guidance SCPU replacement


Guidance SCPU replacement BV Endura
Item to replace Programming hardware Replacement procedure Adjustment & verifi- System verifi-
cation procedure cation
SCPU None chapter Replacing the figure 13 -
SCPU Unit for Endura on page 33
systems on page 63

Fig. 13: Flowchart Adjustments and Verifications after SCPU replacement BV Endura
*
chapter X-ray tube performance test failed BV Endura on page 108 if the X-Ray tube performance
test fails.

Guidance SCPU replacement BV Pulsera


Item to replace Programming hardware Replacement procedure Adjustment & verifi- System verifi-
cation procedure cation
SCPU None chapter Replacing the figure 14 -
SCPU Unit for Pulsera on page 34
systems on page 71

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Fig. 14: Flowchart Adjustments and Verifications after SCPU replacement BV Pulsera
*
chapter X-ray tube performance test failed BV Pulsera on page 109 if the X-Ray tube performance
test fails.

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3.4 Replacement procedures

3.4.1 Replacing the HF generator (BV Pulsera)


To open the HF generator door of the BV Pulsera system:
1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Remove the plastic rear and side covers of the


C-arm stand.
4. Remove the three screws that secure the HF
generator door.
5. The HF generator door can then be swung
round to reveal the HF generator cabling.

Fig. 15: Removing the three screws of the HF genera-


tor door (BV Pulsera)

6. Prevent nuts and washers falling into the sys-


tem.
7. Remove the caps that protect the HF generator
connectors.
8. Disconnect the relevant HF generator connec-
tors.
9. To remove the HF generator, disconnect the ca-
bles and remove the screws that secure the unit
to the door.
10. Replace the HF generator.

Fig. 16: HF generator connectors

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11. Check or position the jumpers on the SEA2


board (figure 3) for 50 or 60 Hz, (the jumper in
the highest position is 50 Hz, in the lowest posi-
tion is 60 Hz). See the settings in table HF gen-
erator: Stator supply board: jumper SEA 2.

Fig. 17: HF generator: Stator supply board : jumper


SEA 2

HF generator: Stator supply board: jumper SEA 2


Mains frequency Jumpers position SEA2
K1 K2
50 Hz IN OUT
60 Hz OUT IN
12. Reassemble in reverse order.
13. Perform the adjustment and verification procedures chapter Guidance HF generator replacement BV
Pulsera on page 27.

NOTICE
After reconnecting the earth cable, perform the electrical safety checks, see chapter Electrical safety
measurements according IEC-62353 on page 112.

3.4.2 Replacing the X-ray tank


3.4.2.1 Removing the X-ray tank cover
To remove the X-ray tank cover:
1. Switch system power OFF.
2. Disconnect the mains plug.
3. Depending on the system version:
• BV Endura: remove the screws that secure the
cover to the console and lift the cover away.
• BV Pulsera: remove the screws and washers
that secure the cover to the console and lift the
cover away.

Fig. 18: Removing the X-ray tank cover

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3.4.2.2 Replacing the X-ray tank

NOTICE
When the X-ray tank is replaced, fit the supplied identification label and the date of the manufacturer
label on the central labeling plate, marked "Ι " on the C-arm stand.

To replace the X-ray tank:


1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Remove the X-ray tank cover chapter Removing the X-ray tank cover on page 36.

WARNING
To prevent injury: prior to removing the tank, put the C-arm into a horizontal position and rest it on a
table.

4. Depending on the system version:


• BV Endura: disconnect the supply cable.
• BV Pulsera: disconnect the supply cables from the X-ray tank by twisting the large connectors and
pulling them off.
5. Depending on the system version:
• BV Endura: release the Allen screws.
• BV Pulsera: release the nuts that secure the tank to the bracket.
Make sure that the X-ray tank is supported.
6. Remove the X-ray tank.
7. Replace the X-ray tank and re-assemble in reverse order.

WARNING
Do not make any modifications to the X-ray tank.

8. For adjustments chapter Guidance X-ray tank replacement on page 28.

3.4.2.3 Mount the X-ray tank cover


To mount the X-ray tank cover:

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

9. Depending on the system version:


• BV Endura: mount the X-ray tank cover and secure it with screws.
• BV Pulsera: mount the X-ray tank cover and secure it with screws and washers.

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CAUTION
First mount the front screws for the cover, then the side screws, to assure the highest possible heat
transmission from the X-ray tank cover.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3.4.3 Replacing the collimator

NOTICE
If the LAT (collimator) option is installed, this procedure also removes the LAT (collimator) that is at-
tached to the collimator.

To replace the collimator:


1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Position the C-arm in a convenient position and make sure that the angulation brake is on.
4. Activate the rotation brake.
5. Remove the X-ray tank cover chapter Removing the X-ray tank cover on page 36.
6. Remove the screws that secure the lead coun-
terweight (if present).
7. Remove the cables from the X1 and X2 DB25
connectors of the LA1 collimator interconnection
board.
8. Remove the shield wires from the collimator in-
terconnection board of the connectors X13 and
X14.
9. Remove the nuts and rings.
10. Gently push the collimator to the right and then
to the front so that the mounting holes are not
touching the alignment screws.
11. Lift off the collimator and place it on a flat sur-
face with the motors facing upwards or side-
ways.

Fig. 19: Replacing the collimator

CAUTION
When the collimator is removed, it may not rest on the motor mounting side, as this may damage the
motor.

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12. Proceed with step 14 if no LAT (collimator) option has been installed.
13. Remove the LAT (collimator) from the collimator.
14. Mount the LAT (collimator) on the new collimator.
15. Place the collimator in position on the mounting pins.
16. Replace the nuts and washers on the pins and tighten slightly.
17. Gently push the collimator towards the rear until the rear left mounting hole is positioned firmly
against the Allen screw.
18. Tighten the nuts.
19. Connect the cables to the X1 and X2 DB25 connectors of the LA1 collimator interconnection board.
20. Insert the shield connector of X1 in X13 and the shield connector of X2 in X14.
21. Remount the counterweight.
22. Check if the collimator functions properly:
• Set the system on.
• Use the collimator controls on the user interface and check if the collimator responds.
23. Install cover and secure it.

NOTICE
After reconnecting the earth cable, perform the electrical safety checks, see chapter Electrical safety
measurements according IEC-62353 on page 112.

3.4.4 Replacing the LAT (collimator)


3.4.4.1 Introduction
The replacement of the LAT (collimator) consists of the following steps:
1. Removal of the X-ray tank cover, chapter Removing the X-ray tank cover on page 36
2. Removal of the collimator, chapter Replacing the collimator on page 38
3. Removal of the LAT (collimator)
4. Mounting the new LAT (collimator)
5. Mounting the collimator, chapter Replacing the collimator on page 38
6. Mounting the X-ray tank cover, chapter Mount the X-ray tank cover on page 37
In this section only the removal and mounting of the LAT (collimator) are described. For other steps
refer to the applicable sections.

3.4.4.2 Procedure to remove the LAT (collimator)

CAUTION
Do not touch the glass surface of the laser.

1. Switch system power OFF.


2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Position the C-arm in a convenient position and make sure that the angulation brake is on.
4. Activitate the rotation brake.
5. Remove the X-ray tank cover, chapter Removing the X-ray tank cover on page 36

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6. Remove the collimator, chapter Replacing the collimator on page 38


7. Disconnect connector LAT X1 from the connec-
tor of the cable form of the Collimator Intercon-
nection Board (item 1 in figure Replacing the
LAT (collimator)).
8. Remove the two screws and washers (item 2 in
figure Replacing the LAT (collimator)) and gently
slide the LAT (collimator) from the collimator.

Fig. 20: Replacing the LAT (collimator)

3.4.4.3 Procedure to mount the new LAT (collimator)


9. Place the LAT (collimator) so that the two guide-
pins on the collimator line-up with the guide-
holes on the LAT.
10. Gently slide the LAT (collimator) on the collima-
tor and make sure that the three guide-pins are
in the corresponding guide-holes:
• two guide-pins on the collimator (items 3)
• one guide-pin at the front of the LAT (collima-
tor) (item 4)

Fig. 21: Placing the LAT (collimator)

11. Place the washers and screws in the mounting


holes (items 6) and tighten to secure the LAT
(collimator).
12. Connect connector LATX1 (item 5) to the con-
nector of the cable form of the Collimator Inter-
connection Board.
13. Mount the collimator, chapter Replacing the col-
limator on page 38
14. Mount the X-ray tank cover, chapter Mount the
X-ray tank cover on page 37

Fig. 22: Mounting the LAT (collimator)

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NOTICE
When the LAT (collimator) is replaced, fit the supplied identification label and the date of the manufac-
turer label on the central labeling plate, marked "Ι " on the C-arm stand.

3.4.5 Replacing the LAT (II)


3.4.5.1 Introduction
The LAT (II) consists of three replaceable units:
1. LAT (II) battery
2. LAT (II)
3. LAT (II) tightening strap

3.4.5.2 Procedure to replace the LAT (II) battery


1. Pull the LAT (II) laser until it snaps out. (The
LAT (II) lasers are locked to the mounting plates
of the tightening strap by spring force.)

Fig. 23: Removing the LAT (II) laser

2. Remove the metal cap of the LAT (II) by a quar-


ter counterclockwise turn.

Fig. 24: Opening battery compartment of LAT (II)

3. Remove the old battery.


4. Insert the new 1.5 V battery, make sure that the
plus pole points towards the cap.
5. Put the cap back on and turn it clockwise under
gentle pressure to tighten it.

Fig. 25: Inserting battery

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6. Press the red button and check that the laser


generates a laser line.

NOTICE
The laser switches off automatically, after a pre-
defined period of time.

Fig. 26: Functional test of the LAT (II)


7. Snap the LAT (II) back onto the mounting plate.
Make sure that the LAT (II) snaps noticeably.
8. If necessary repeat the procedure for the sec-
ond LAT (II).

3.4.5.3 Procedure to replace the LAT (II)


1. Pull the defect LAT (II) laser until it snaps out.
(The LAT (II) lasers are locked to the mounting
plates of the tightening strap by spring force.)

Fig. 27: Removing the LAT (II) laser

2. Remove the metal cap of the new LAT (II) by a


quarter counterclockwise turn.

Fig. 28: Opening battery compartment of LAT (II)

3. Insert the 1.5 V battery, make sure that the plus


pole points towards the cap.
4. Put the cap back on and turn it clockwise under
gentle pressure to tighten it .

Fig. 29: Inserting battery

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5. Press the red button and check that the laser


generates a laser line.

NOTICE
The laser switches off automatically, after a pre-
defined period of time.

Fig. 30: Functional test of the LAT (II)


6. Snap the LAT (II) onto the mounting plate. Make
sure that the LAT snaps noticeably.

3.4.5.4 Procedure to replace the LAT (II) tightening strap


1. Positon the C-arm in a way that you have easy
access to the II tube during the next steps.
2. Pull the first LAT (II) laser until it snaps out. (The
LAT (II) lasers are locked to the mounting plates
of the tightening strap by spring force.)
3. Pull the second LAT (II) laser until it snaps out.

Fig. 31: Removing the LAT (II) laser

4. Open the buckle.


5. Remove the buckle from the II tube.

Fig. 32: Opening the buckle

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6. Place the tightening strap around the II tube.

Fig. 33: Attaching the tightening strap

7. Turn the tightening strap until the buckle is at


the C-arm side of the II tube.

Fig. 34: Attaching the tightening strap

8. Insert the hook into its counterpart.

Fig. 35: Inserting the hook

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9. Make sure that the tightening strap is parallel to


the edge of the II tube.

Fig. 36: Aligning the tightening strap

10. Press the tightening strap [1] onto the II tube [2]
and make sure that it fits well at the whole cir-
cumference of the II tube. A slight curvature on
the tightening strap where the buckle is welded
is normal.

Fig. 37: Fitting of the tightening strap

11. Close the lever until the hook touches its coun-
terpart and force must be asserted to close the
lever further.

Fig. 38: Closing the lever

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12. Measure the distance of the lever's tip to the


hook's tip. The distance must be 70 mm.

Fig. 39: Measuring the lever distance

13. If the distance is not correct, open the buckle


and adjust the hook.
• Turn the hook in direction B to increase the
lever distance or in direction A to reduce it.
14. Insert the hook and measure the distance again.

Fig. 40: Adjusting the hook

CAUTION
Excessive force can damage the buckle
If you have to assert excessive force in the next step, abort the procedure and check the tightening
strap alignment and lever distance setting.

15. Close the buckle until the locking spring engag-


es.
16. Verify that the lever is locked.
17. Verify that the tightening strap is in correct posi-
tion and that it cannot be moved. (If not OK, re-
move the tightening strap and repeat the mount-
ing procedure.)
18. Snap both LAT (II) lasers back onto the mount-
ing plate. Make sure that the LAT (II) lasers Fig. 41: Closing the buckle
snaps noticeably.

3.4.6 Replacing the LAT (3D-RX)

NOTICE
This replacement is only applicable for systems with the 3D-RX option.

1. Switch system power OFF.


2. Disconnect the mains plug.
1. Loosen the screws (4x) of the cover of the laser unit.
2. Disconnect the connector to the switch of the laser.
3. Disconnect the connector to the laser.
4. Loosen the screws (2x) to disconnect the laser unit from the C-arm.

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5. Cut the ty wrap.

NOTICE
Do not damage the cable while cutting the ty wrap.

6. Take out the laser unit.


7. Replace in reverse order.

3.4.7 Replacement of Image Detection Subsystem components


3.4.7.1 Introduction
In the table Replacement procedures IDS components the applicable procedures are listed for the IDS
components: II assembly, II insert, II power supply, II housing, Camera Lens Assembly, Control Board
and Interface board. For other IDS FRU replacement procedures refer to Service Manual FL-IDS-23-
SUR or Service Manual FL-IDS-31-SUR on InCenter

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IDS replacement guidance table

3.4.7.2 Replacing the II-container

NOTICE
When the II-container is replaced, fit the supplied identification label and the date of the manufacturer
label on the central labeling plate, marked "Ι " on the C-arm stand.

NOTICE
Due to the heavy weight of the II-container, two persons should carry out this procedure.

Removing the II-container


To remove the II-container from the C-arm:

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1. Put the X-ray tank on a support.


2. Lock the C-arm brake.

Fig. 42: Step 1

3. Remove the camera top cover from the II con-


tainer.
4. Disconnect the cables marked BA1–X1 and
BA1–X2.

Fig. 43: Step 2

CAUTION
Removing the II container may unbalance the C-arm. To prevent this, always first position the C-arm
so that the X-ray tank rests on a table.

5. Remove the Allen screws that secure the con-


tainer to the C-arm. The number of screws to be
removed, depends on the system version (9” or
12”). Ensure that the X-ray tank is supported.
6. Pull off the II container together with all its inter-
nal electronics. The II container is heavy, there-
fore two persons should carry out this proce-
dure.
Fig. 44: Step 4

NOTICE
In case of the 3D-RX option, perform the procedure for 3D-RX calibration.

3.4.7.3 Removal of the top-cover assembly


1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

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3. Remove the 3 caps covering the screws.


4. Remove the 3 screws.
5. Lift the top-cover assembly from the subsystem.

Fig. 45: Removing the II assembly top cover

3.4.7.4 Removal of the II power supply


Removal of the II power supply (23 cm)
1. Set the insert housing in the vertical position.
2. Disconnect all cables.
3. Disconnect the earth contact.
4. Remove the M4 hexagon distance piece with an
open end spanner no. 7.

Fig. 46

5. Lift the power supply from the insert housing.

Removal of the II power supply (31 cm)


1. Disconnect all cables of the power supply.

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2. Remove the two screws (22).

Fig. 47

3. Disconnect the earth wire.


4. Remove the mounting bracket (13).

3.4.7.5 Removal of the balance weights & stub


1. Put the X-ray tank on a support.
2. Lock the C-arm brake.
3. Remove the 2 balance weights, each mounted
with 2 screws.
4. Remove the stub.

Fig. 48: Removing the balance weight and stub

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3.4.7.6 Removal of the metal top-cover of the Camera Lens Assembly


1. Partly loosen the 4 screws of the metal top-cov-
er of the Camera Lens Assembly.
2. Lift the top-cover of the Camera Lens Assembly.

Fig. 49: Removing the top cover from the Camera Lens
Assembly.

3.4.7.7 Removal of the Interface Board


1. Take the necessary precaution to work in an
ESD safe way.
2. Disconnect the cables from connectors J1, J2,
J3, J5, J6, J7 & J10 (if present).

NOTICE
Handle the flex-foil cable connected to J1 with
care. The tag must be gently rotated upwards to
unlock fixation.
Fig. 50: Unlocking the Channel Link connnector

3. Remove the screws from connectors J3 & J7


with which they are attached to the EMC shield.
4. Remove the screws that hold the PCB down
from the top.
5. Gently slide the PCB outwards (away from the
EMC shield) and put it aside.

Fig. 51: Removing the screws of connectors J3 & J7

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3.4.7.8 Removal of the Control Board


1. Take the necessary precaution to work in an
ESD safe way.
2. Disconnect the cables from connectors X2, X11
& X12.
3. If there are cables connected to X3 and/or X4
then disconnect them.
4. Remove the stubs that hold the PCB down from
the top.
5. Remove the screws from connector X1 with
which it is attached to the EMC shield (use a
pair of tweezers and be careful not to loose the Fig. 52: Removing the screws of connectors X1
washers).
6. Gently slide the PCB up- & outwards (away from
EMC shield) and put it aside.

3.4.7.9 Removal of the Camera Lens Assembly


1. Disconnect the cables leading to the Interface
Board

Fig. 53: Disconnecting the Iris control & Camera power


supply connectors.

2. Disconnect the flex-foil cable from connector


CON301.

NOTICE
Handle the flex-foil cable and tag with care. The
tag must be gently rotated upwards to unlock fix-
ation.

Fig. 54: Disconnecting the CON301 (Channel Link)


connector

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3. Loosen, but do not remove, the 4 spring-loaded


screws clamping the Camera Lens Assembly
down on the II-assembly (only 3 visible).
4. Carefully lift the Camera Lens Assembly up-
wards from the II-assembly.

NOTICE
Do not damage the cables & other components,
while removing the Camera Lens Assembly.

Fig. 55: Releasing the Camera Lens Assembly

3.4.7.10 Removal of the grid


5. Note the orientation of the grid.

NOTICE
When mounting the grid later on, you must re-
member the precise orientation of the grid.

6. Remove the 4 countersunk screws and remove


the grid.

Fig. 56: Removal of the grid

3.4.7.11 Removal of the II insert from the II housing


Removal of the II insert from the II housing (23 cm)
1. Set the insert housing in the vertical position.

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2. Remove the two M4 inside hexagon screws of


the plate that covers the cable opening.

Fig. 57

3. Remove the plate that covers the cable opening.


4. Disconnect all cables.
5. Disconnect the earth contact.
6. Remove the two M3 BZK screws that attach the
II insert to the II housing.

Fig. 58

7. Remove the eight M4 countersunk screws from the entrance ring.


8. Remove the entrance ring.

Fig. 59

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9. Loosen the M4 inside hexagon screws of the


four fixation plates a few turns.

Fig. 60

10. Push the four fixation plates with a screwdriver


towards the outside of the II insert.

Fig. 61

11. Keep the fixation plates pushed with the screwdriver and attach the screws.
12. Turn the front plate five degrees clockwise with two hands.
13. Lift the front plate from the key groove.
14. Remove the insert.

Removal of the II insert from the II housing (31 cm)


1. Disconnect all cables of the power supply.
2. Remove the optical lens.

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3. Remove the parts of the entrance plate.

Fig. 62

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4. Loosen the three screws (3).

Fig. 63

5. Remove the insert (2).

3.4.7.12 Mounting of the II insert in the II housing


Mounting of the II insert in the II housing (23 cm)
Execute the steps to remove the II insert from the II housing in reverse order (chapter Removal of the II
insert from the II housing (23 cm) on page 54).

Mounting of the II insert in the II housing (31 cm)


Execute the steps to remove the II insert from the II housing in reverse order (chapter Removal of the II
insert from the II housing (31 cm) on page 56). You must torque the screws in this procedure to 7.5
Nm.

3.4.7.13 Mounting of the grid


1. Mount the grid with the correct orientation using the screws.

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3.4.7.14 Camera focusing


Camera focusing (23 cm)
1. Put on latex gloves.
2. Hold your fingers at the bottom side of the adap-
tor.

Fig. 64

3. Turn the ring until the alignment mark is in line


with the 0 mark on the scale.

Fig. 65

Camera focusing (31 cm)


1. Put on latex gloves.
2. Record the marking on the II assembly that indicates the correction of the focus.
3. Hold your fingers at the bottom side of the adaptor.
4. Turn the inner ring until the mark on the scale is in line with the recorded marking on the II assembly
that indicates the correction of the focus.

3.4.7.15 Mounting of the Camera Lens Assembly

NOTICE
Before mounting the Camera Lens Assembly refer to the Camera focusing adjustment procedure.

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NOTICE
Make sure that the optics of the Camera Lens Assembly is clean. Dust particles can be removed with
clean, dry air. Other contaminations can be removed by means of non-fluffing Q-tips and alcohol.
Use each Q-tip only once and make straight movements across the lens.

NOTICE
Do not damage the cables & other components, while positioning the Camera Lens Assembly.

5. Position the new Camera Lens Assembly.


6. Insert the 4 spring-loaded screws into the new
Camera Lens Assembly (only 3 visible).
7. Check the II output window for dust or contami-
nation. If necessary, clean.
8. Lower the CLA onto the II-assembly and tighten
the 4 spring-loaded screws.
9. Reconnect the cables to the Iris, Channel Link
and Camera power supply.

NOTICE
Handle the flex-foil cable connected to J1 with
care. The tag must be gently rotated downwards
to lock the fixation. Make sure that the flex-foil is
guided correctly and is not buckled.

Fig. 66: Mounting the Camera Lens Assembly

3.4.7.16 Mounting of the Control Board


1. Gently slide the PCB inwards (to the EMC shield) and position it on the mounting stubs.
2. Partly insert the screws to attach connector X1 to the EMC shield.
3. Mount the stubs that hold the PCB down from the top.
4. Fully tighten the screws for connector X1.
5. Connect the cables to connectors X2, X11 & X12.
6. If desired connect the cables to connectors X3 and/or X4.

3.4.7.17 Mounting of the Interface Board 1


1. Gently slide the PCB inwards (to the EMC shield) and position it on the mounting stubs.
2. Partly insert the screws to attach connectors J3 & J7 to the EMC shield.
3. Mount the stubs that hold the PCB down from the top.
4. Fully tighten the screws for connectors J3 & J7.

NOTICE
Handle the flex-foil cable connected to J1 with care. The tag must be gently rotated downwards to lock
the fixation. Make sure that the flex-foil is guided correctly and is not buckled.

5. Connect the cables to connectors J1, J2, J3, J5, J6, J7 & J10 (if present).

3.4.7.18 Mounting of the metal top-cover of the Camera Lens Assembly


1. Position the top-cover of the Camera Lens Assembly.
2. Tighten the 4 screws of the metal top-cover of the Camera Lens Assembly.

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3.4.7.19 Mounting of the balance weights &amp; stub


1. Mount the stub.
2. Mount the 2 balance weights.

3.4.7.20 Mounting of the II power supply


Mounting of the II power supply (23 cm)
3. Insert the power supply in the insert housing.
Make sure that the pins of the power supply are
in the holes of the insert housing.

Fig. 67

4. Install the M4 hexagon distance piece with an open end spanner no. 7.
5. Connect the earth contact.
6. Connect all cables.

Mounting of the II power supply (31 cm)


7. Install the mounting bracket (13).

Fig. 68

8. Connect the earth wire.


9. Attach the two screws (22).
10. Connect all cables of the power supply.

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3.4.7.21 Mounting of the top-cover assembly


1. Check that the copper EMC gasket is mounted correctly in the inside of the top-cover.
2. Lower the top-cover assembly onto the subsystem.
3. Mount the 3 screws.
4. Mount the 3 caps to cover the screws making sure that the orientation, of the caps, is in line with the
shape of the top-cover.

3.4.7.22 Installing the II-container


1. Install the II container together with all its internal electronics. The II container is heavy, therefore two
persons must carry out this procedure.
2. Attach the Allen screws that secure the container to the C-arm. The number of screws depends on
the system version (9” or 12”). Make sure that the X-ray tank is supported.
3. Connect the cables marked BA1–X1 and BA1–X2.
4. Unlock the C-arm brake.

3.4.7.23 Software installation Control Board


1. Connect the service PC to connector X3 of the control board. Use connector 0 and the RJ45 cable
from the cable kit.
2. Start up the BV Family system in normal mode.
3. Insert the CD with Surgery software in the service PC.
The software will start automatically.

Fig. 69: Start up screen Software Download

4. Select the subsystem Install II type 23cm (9")


or Install II type 31cm (12").
5. Switch system power OFF, when the pop-up ap-
pears.
6. Place jumper X5 on controller board in down-
load (DL) mode.
7. Switch system power ON and wait 1 minute be-
fore clicking |OK| .
Fig. 70: Pop-up Start Boot mode

After clicking on the OK button downloading of embedded and configuration software will start. Prog-
ress can be followed on the screen.

Fig. 71: Progress window Software Installation


At the end of downloading, the following pop-up will appear.

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Fig. 72: Installation Result Control Board Software

8. Click |OK| and close all Windows


9. Switch system power OFF.
10. Place jumper X5 on controller board in normal (NOR) position.
11. Remove the CD from the service PC.
12. Switch system power ON.

3.4.8 Replacing the SCPU Unit


3.4.8.1 Replacing the SCPU Unit for Endura systems
Procedure to replace the SCPU (Stand Control and Power Unit):
1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Disconnect the C-arm stand from the MVS.


4. Remove the rear and the left covers of the C-arm stand.
5. Disconnect connectors from the left side of the
SCPU (connectors SCN-X1 to SCN-X22). Make
sure that the cables are labeled. If a cable is not
labeled, add a label to the cable.

Fig. 73: Removing all connectors

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CAUTION
Make sure that the cables from the backside of the SCPU are behind the SCPU. If not, they are dam-
aged when the SCPU is rotated out the stand.

6. Remove the EMC cover (on right side of the C-


arm stand).

Fig. 74: Removing the EMC cover

7. Unscrew and remove the hexagon plugs (figure 75 on page 65 items 1 and 2).
8. Disconnect connectors SCN-X23, SCN-X25 and SCN-X26.
9. Unscrew and remove the EMC brackets (figure 75 on page 65 items 3, 4 and 5).
10. Loosen the cables from the grip in the order specified in the image.

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Fig. 75: Removing connectors and EMC brackets

11. Remove the Allen screw that holds the SCPU


on the left side.

Fig. 76: Release SCPU (1)

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12. While supporting the SCPU, remove the Allen


screws (4x) on the right side that hold the
SCPU.

Fig. 77: Release the SCPU

13. Remove the SCPU carefully.

Fig. 78: Lifting the SCPU

WARNING
Make sure that your fingers do not get stuck under the SCPU.

14. Unscrew the bracket from the old SCPU and


mount it on the new SCPU.

Fig. 79: Mounting the bracket to the new SCPU

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15. Put the new SCPU into the C-arm stand and
tighten the Allen screw on the left side.
16. Make sure that no cables are squeezed be-
tween the cable strip and the frame.
17. Tighten the Allen screws on the right side of the
SCPU.

Fig. 80: Mounting new SCPU

18. In the order as listed below, mount the EMC brackets and reconnect connectors SCN-X23, SCN-
X25 and SCN-X26, see figure Mounting EMC brackets, connecting X26, X25 and X23:
• Position the thick cable of connector SCN-X26 to the left side and the thin cable of connector SCN-
X26 to the right side. Make sure the screw holes are accessible.
• Mount the EMC bracket.
• Connect connector SCN-X26.
• Mount the hexagon plug near SCN-X26.
• Position the cable of connector SCN-X25 and use the smallest EMC bracket to attach the cable.
• Connect connector SCN-X25.
• Position the cable of connector SCN-X23 and use the largest EMC bracket to attach the cable.
• Connect connector SCN-X23.
• Mount the hexagon plug near SCN-X23.
• Make sure that the EMC cable brackets make contact with the shielding of the cables.

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Fig. 81: Mounting EMC brackets, connecting X26, X25 and X23

CAUTION
Only use the hexagon plugs that are supplied. If the supplied hexagon plugs are broken, do not use
other plugs.
The EMC shielding is a separate FRU, which contains these hexagon plugs.

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19. Make sure the cable routing is correct.


20. Mount the EMC cover (2 Allen screws).
21. Reconnect all connectors on the left side of the
SCPU, start with SCN-X22 (below) and end with
SCN-X1 (top).
22. Mount covers.

Fig. 82: Cable routing

23. Connect the cable between the C-arm stand


and the MVS.
24. Connect a cross cable between the service PC
and the Service ethernet port of the DFI.
25. Switch on the system via the MVS.
26. Select the Setup window on the MVS.
27. Select the "Service enable" button.
28. Start BV-Scope. The target adress confirmation
window appears.

Fig. 83: Step 11.

29. Enter the service IP address: see Setup tab on


MVS monitor.
30. In BV-Scope select Install > Connect. The win-
dow below appears.

Fig. 84: Target Adress Confirmation window

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31. Click on OK to proceed.

Fig. 85: Warning when performing a re-connect action

Fig. 86: Install > Connect


32. Select Re-connect in the action field.
33. Click on OK. The window below appears

Fig. 87: Selection screen Re_connect SCPU


34. Select "Yes" in the settings menu " Re-connect SCPU"
35. Click the OK button. The window below appears

Fig. 88: Confirmation window


36. Click the OK button
37. Restart the system on the MVS.
38. If a message appears on the C-arm stand display, restart the system again (on the MVS stand).

Checks
1. In BV-Scope select Install > Program Manual > System Configuration.
2. Check the Host Identification field.
3. Check the SW License Key field.
4. Check the System Serial Number field.

NOTICE
Send a replaced SCPU to the factory in Best in the box of the new SCPU. Do fill in the Engineer’s
Form to Return Parts (EFRP). The information of the fault description is important for analyzing the
SCPU by the factory.

When a new SCPU is placed, perform adjustments and verifications (chapter Guidance SCPU replace-
ment on page 33).

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NOTICE
After reconnecting the earth cable, perform the electrical safety checks, see chapter Electrical safety
measurements according IEC-62353 on page 112.

3.4.8.2 Replacing the SCPU Unit for Pulsera systems


Procedure to replace the SCPU:
1. Switch system power OFF.
2. Disconnect the mains plug.

WARNING
With the mains plug disconnected, electrical components of the BV Family system can
still be charged.
Refer to section 'Electrical safety' and follow the safety instructions to prevent a fatal electrical shock.

3. Disconnect the C-arm stand from the MVS.


4. Remove the rear and the left covers of the C-arm stand.
5. In case of 3D-RX option, disconnect all connec-
tors from the 3D-RX interface unit.

Fig. 89: Removing all connectors

6. Disconnect all connections from the power sup-


ply of the 3D-RX interface unit with a screwdriv-
er.

Fig. 90: Disconnecting the connections.

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7. Remove the three screws that secure the gener-


ator door.
8. Open the generator door.

Fig. 91: Opening the generator door.

9. Remove the bolts that hold the ESU (4x).

Fig. 92: Releasing the ESU.

10. Remove the ESU from the C-arm stand.

Fig. 93: Removing the ESU.

NOTICE
It is not necessary to disconnect the ESU connectors.

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11. Disconnect all connectors from the SCPU.

12. Remove the allen screws (5x) that hold the


SCPU.

Fig. 94: Releasing the SCPU.

13. Slide the SCPU out of the C-arm stand.


14. Replace the SCPU.
15. Re-assemble in reverse order.

Fig. 95: Replacing the SCPU.

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4 Adjustment

4.1 Definition
To bring various component parts up to a true or more effective relative position for performance pur-
poses.

4.2 Adjustment and verification procedures

4.2.1 X-ray tube


4.2.1.1 Calibration reset
1. In BV-Scope select: Install > Adjustment > X-ray tube > Filament
2. Start LDF with the left hand switch or the left foot switch.
3. Make sure that the system initiates radiation.
4. Click |CANCEL| to cancel the procedure.
Canceling the Filament procedure while it is in progress will reset the calibration data.

4.2.1.2 Conditioning
The conditioning of the X-ray tube must be used when the X-ray tube is not used for more than 3
months.

CAUTION
Before you start this procedure, place a lead plate on top of the diaphragm cover (X-ray protection).

Procedure:
1. Select BV-Scope path: Install > Adjustment > X-ray tube > Conditioning.
2. Follow the procedure as described in BV-scope. Change the kV value on the stand UI, not in BV-
Scope.

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Fig. 96: Install > adjustment > X-ray Tube > Conditioning panel

4.2.1.3 X-ray tube voltage adjustment (BV Endura)


This section is applicable to BV Endura only.

Probe positioning
1. Install the 20cm spacer (IEC) if not already in-
stalled.

NOTICE
The 20cm spacer is delivered with the system. If
necessary, it can be ordered as a sparepart.

Fig. 97: 20cm spacer (IEC)

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2. Place the dose/kV probe at the 20cm spacer.

Fig. 98: Correct position of dose/kV probe

3. At the stand User Interface:


• Select kV manual
• Set kV to 72 kV
• Select Auto Contrast/Brightness on
4. Start HDF (right hand or footswitch) and verify
the image on the left monitor with the picture.
5. Move the probe in such a way that all measuring
fields of the probe are visible in the image.

Fig. 99: Example of correct image with all measuring


fields of the dose probe visible (e.g. Unfors Xi Platinum
dose probe in this case)

Voltage adjustment in BV-Scope


1. Select BV-Scope path: Install > Adjustment > X-ray tube > Voltage.
2. Perform the BV-Scope window instructions.

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Fig. 100: Install > adjustment > X-ray Tube > Voltage

4.2.1.4 Filament gain adjustment (BV Pulsera)


1. Remove the stand rear cover.
2. Place lead on the X-ray tube.
3. Remove the connectors from the optional 3D-RX interface unit and lift the unit upwards.
4. Make a backup of the examination settings. In BV-scope select: Install > Export > Examination
5. Install the default examination settings.
• In BV-scope select: Install > Program automatic > Examination
• Check Intern and click |OK|.
• Select: "IQ traditional".
6. Restart the system.
7. On the Stand UI Select the following settings:
• Examtype: Abdominal
• X-mode: Continuous Fluoro
• kV manual: 72 kV
8. Remove the generator cover plate.
9. Connect a multimeter on SEA1 between TP0 and TP6.
10. Start HDF and measure the voltage during fluoroscopy. (1V = 10 mA).

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11. Adjust the mA actual with potentiometer R27 on


SEA3 of the X-Ray generator until the displayed
value equals 19.8 mA ± 0.03 mA.

Fig. 101: R27 on SEA3 of the X-ray Generator

12. Restore the backup from step 4.


• In BV-scope select: Install > Program automatic > Examination
• Select Extern (Service PC) and click |Browse...|
• Select the file created in step 4.
13. Restart the system.
14. Proceed with the Filament adjustment procedure, in case Radiography has been enabled.

4.2.1.5 X-ray tube filament adjustment


Procedure for BV Endura
This procedure is only applicable to BV Endura systems with Radiography enabled. Within the proce-
dure, the X-ray tube current will be adjusted for radiography.

CAUTION
Before you start the filament adjustment make sure that fuses F1 and F2 on the WA1 board are 30A in
case the mains voltage is 130V or lower.

1. Select BV-Scope path:: Install > Adjustment > X-ray tube > Filament .
2. Perform the BV-Scope window instructions.

Fig. 102: Filament adjustment panel (BV Endura)

Procedure for BV Pulsera


Within this procedure, the X-ray tube current will be adjusted for radiography.

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1. Select BV-Scope path: Install > Adjustment > X-ray tube > Filament.
2. Perform the BV-Scope window instructions.

Fig. 103: Install > Adjustment > X-ray Tube > Filament panel (BV Pulsera) (step 1 of 1)

3. If the adjustment is successful then proceed with the next adjustment or verification according the
guidance. If the adjustment is not successful, proceed with the filament feedback and repeat the fila-
ment adjustment procedure.

4.2.1.6 Dose output adjustment


Calibrating the dose output measurement is essential for correct dose indications.

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Fig. 104: Install > Adjustment > X-ray Tube > Dose Output panel (step 1 of 7)
1. Select Install > Adjustment > X-ray tube > Dose output
2. Perform the BV-Scope window instructions (step 1 - 7).

NOTICE
The indicated dose rate and dose on the operator’s panel of the C-arm stand are the one at 30 cm
distance from the image detector. The dose rate and dose are measured at the image detector and
then the values at 30 cm distance are calculated.

4.2.1.7 Dose limiting adjustment


Default values

Dose at legal position


Dose at legal position Measured dose output (μGy / s)
BV Endura 400
BV Pulsera 750

Default legal dose limits


Mode Limit name default, μGy/s for HHS (legal limit - 5%)
LDF Manual kV Dose A 1382
HDF Manual kV Dose B 2765
LDF Automatic kV Dose C 1382
HDF Automatic kV Dose D 2765
The procedure described in this section is only necessary if C-arm stand additional (local) laws & regu-
lations require a lower max dose output than the one required by HHS. When the system has to com-
ply with HHS, just make sure that all figures, as mentioned in the table 'Dose at legal position' and ta-
ble'Default legal dose limits', are entered or set by default. The dose-limiting feature depends on a cor-
rectly calibrated system, including a calibrated dose output indication. Refer to chapter 'Dose output
adjustment'. To carry out the dose limiting procedures, it is essential to have a calibrated dosimeter
available. After completing the procedure, it is necessary to check the results with the dosimeter again.

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Dose limiting procedure


1. Select Install > Adjustment > X-ray tube > Dose limiting
2. Perform the BV-Scope window instructions (step 1 of 1).
Example Dose limiting panel for BV Endura:

Fig. 105: Install > Adjustment > X-ray Tube > Dose Limiting panel (BV Endura) (step 1 of 1)
Example Dose limiting panel for BV Pulsera:

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Fig. 106: Install > Adjustment > X-ray Tube > Dose Limiting panel (BV Pulsera) (step 1 of 1)
Step 1 - Place the dose probe at the legal required position (for example 30 cm from the image detec-
tor for HHS). Measure the dose output and enter the measured value in the corresponding field.

Dose at legal position


Maximum dose output (μGy / s)
Dose to be measured at 30 cm before .............................................
the entrance screen of the image detec-
tor

Legal dose limits


Mode Limit name Required legal limit (uGy / s)
LDF Manual kV Dose A
HDF Manual kV Dose B
LDF Automatic kV Dose C
HDF Automatic kV Dose D

NOTICE
LDF mode: left button, normal fluoro.
HDF mode: right button (audible signal), boost fluoro or pulsed exposure.

Step 2 - Enter the legal limits A, B, C D in the corresponding fields (refer to the written values in table
'Legal dose limits').
Step 3 - Enter the legal limits A, B, C D in the corresponding fields.
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Step 4 - Restart the system. The system now automatically calculates which is the max-allowed kV
value for a certain X-ray mode, being the minimum level of the LDF and HDF kV limit (left and right
button have the same kV limit).
Step 5 – Check whether the system complies with the local regulations;
For manual mode - Put 5 mm lead on II surface. Set kV manual to max possible value. Confirm by
measuring that the dose output at legal position is below the limit for both LDF and HDF. Repeat this
procedure for all Xray modes (LDF, HDF, and Pulsed exposure) and all exam types.
For automatic modes - Put 5 mm lead on II surface. Perform fluoroscopy until system stabilizes.
Confirm by measuring that the dose output at legal position is below the limit for both LDF and HDF.
Repeat this for all X-ray modes (LDF, HDF, and Pulsed exposure) and all exam types.

NOTICE
For pulsed exposure modes (BV Pulsera only): in cases where the max kV setting is well below 110
kV, fieldservice is advised to limit the max pulsed frame to 15 frames / s instead of the default 30
frames / s in the BV-Scope menu. This should then give a full kV range up to 110 kV.
The hospital application specialist has to be consulted before the action.

NOTICE
The left and right buttons (LDF and HDF) have the same kV limit. This means that in cases where the
max kVis limited only by the HDF dose limit, the LDF mode will be limited too. When this is unwanted,
it is also possible to completely disable HDF mode in the BV-Scope menu. This should then give a full
kV range up to 110 kV.
In case of doubt contact the hospital application specialist.

NOTICE
Perform the procedures in the section ’Maximum patient entrance dose’.

4.2.1.8 Exposure time verification


In order to meet approbation/approval requirements the deviation of the exposure time of the radiogra-
phy mode shall not exceed the system specification quoted in the Instructions for Use and service doc-
umentation.
Procedure:

NOTICE
Depending on the available examination type a certain exposure time may not be available.

1. Place the dosemeter with time function in the beam at a suitable position.
2. Select radiographic mode.
3. Select 70kV.
4. Select the applicable radiographic mode:
• For BV Endura systems: 5.0 mAs.
• For BV Pulsera systems: 3.2 mAs.
5. Measure the exposure time and verify the value against the rejection limits listed in the applicable ta-
ble Exposure time limits.
6. Record the value in the System Reference Manual.
7. Repeat the exposure time measurement for the next test setting listed in the table.

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Exposure time limits BV Endura


Mode Setting Rejection limits (ms)
Min Max
Radiography 70 kV - 5.0 mAs 240.3 259.7
70 kV - 80 mAs 3991 4009
High power radiography 105 kV - 3.2mAs 100.4 113.0
(if enabled)

Exposure time limits BV Pulsera


Mode Setting Rejection limits (ms)
Min Max
Radiography 70 kV - 3.2 mAs 50.9 55.7
70 kV - 6.3 mAs 102.4 107.6
70 kV - 125 mAs 2073 2094

4.2.2 Collimator adjustments


Adjustment of the iris is essential for the selectable X-ray radiation field. After a correct adjustment of
the iris, the selection at the C-arm stand or MVS is equal to the “real” shutters and position of the iris in
the collimator.

4.2.2.1 Iris adjustment


This procedure is used to calculate the iris size for LIH and for all II formats.

Fig. 107: Iris panel (step 1 of 6)


1. Select Install > Adjustment > Collimator > Iris.
2. Make sure that the C-arm is in the upright position (angulation and rotation of 0 degrees).
3. Perform the BV-Scope window instructions (steps 1 - 6).

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To align the collimator, turn the three screws at positions A and B (figure 108 on page 85). You must
position the iris edges, which are visible on the monitor (figure 109 on page 86), between the two
yellow circles.

Fig. 108: Positions A and B on the collimator

NOTICE
For the iris verification procedure, refer to section 'Iris verification'.

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Fig. 109: Iris adjustment with 2 circles (Example)

4.2.2.2 Shutter adjustments


Shutter A

Fig. 110: Install > Adjustment > Collimator > Shutter A panel (step 1 of 6)
1. Select Install > Adjustment > Collimator > Shutter A

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Fig. 111: Install > Adjustment > Collimator > Shutter A panel (step 2 of 6)
2. Perform the BV-Scope window instruction (step 1 to 6).

NOTICE
For the shutter A verification procedure, refer to section 'Shutter verification'.

Shutter B
Refer to the identical adjustment procedure of shutter A, refer to section 'Shutter A'. To verify the ad-
justment of shutter B follow the verification procedure as described in section 'Shutter verification'.

4.2.3 Laser adjustment and verification


4.2.3.1 Laser alignment LAT (collimator)
The mirror of the LAT (collimator) must be mechanically aligned to make sure that the cross-beam of
the laser is projected such that it is at the same position as the centre of the X-ray beam. For this pur-
pose, the LAT (collimator) has a facility to adjust the mounting position of the mirror.

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Fig. 112: Install > Adjustment > Collimator > Laser Alignment panel (step 1 of 1)
1. Select Install > Adjustment > Collimator > Laser alignment.
2. Perform the BV-Scope window instruction (step 1 of 1). Adjustment details:
• Loosen the screws of the bracket and rotate the laser to adjust the laser beam perpendicular to the
line on the grid.
• Loosen the both screws (item 1 in figure LAT (collimator) alignment) to set the horizontal position.
• Loosen the both screws (item 2 in figure LAT (collimator) alignment) to set the vertical position.
• Fasten the screws after adjustment.

Fig. 113: LAT (collimator) alignment

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4.2.3.2 Laser adjustment LAT (II)

NOTICE
Tiny mechanical movement already causes a major change of the position of the laser
lines.
Adjust the LAT (II) with care and sensitivity.

1. Loosen two screws and remove the protective


cap.

Fig. 114: Removing the protective cap

2. Turn the adjustment screw for rotation until the


laser lines are perpendicular to each other.
3. Use a right triangle or a sheet of paper to check
the adjustment.

NOTICE
If you change the direction of rotation of the
adjustment screw, you will notice some
play in the adjustment.
This is normal and does not indicate a fault.

Fig. 115: Rotating the laser line

4. Turn the adjustment screw for transverse shift


until the laser lines intersect at the centre point
of the X-ray beam.

Fig. 116: Transversing the laser line

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5. Turn the adjustment screw for longitudinal shift


until the maximum brightness of the laser lines
is in the centre point.

Fig. 117: Longitudinal shift of the laser line

6. Make sure that the following criteria are met:


• the laser lines are perpendicular to each other
[1]
• the laser lines intersect at the centre point of
the X-ray beam [2]
• the maximum brightness of the laser lines is in
the centre point [3]
7. Mount the protective cap.

Fig. 118: Three criteria for LAT (II) adjustment

4.2.4 IDS adjustment


4.2.4.1 II focus
Within this procedure, the II focus will be adjusted.

Fig. 119: Install > Adjustment > Image Detection Subsystem > II Focus panel (step 1 of 2)
1. Select: Install > Adjustment > Image Detection Subsystem > II Focus
2. Perform the BV-Scope window instructions (step 1 of 2).

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Fig. 120: Install > Adjustment > Image Detection Subsystem > II Focus panel (step 2 of 2)
3. Perform the BV-Scope window instructions (step 2 of 2).

4.2.4.2 Camera centring


This procedure is used to adjust the mechanical centring of the camera, so that the image of the II out-
put screen is in the centre of the camera.

Fig. 121: Install > Adjustment > Image Detection Subsystem > Camera Centring (step 1 of 1)
1. Select BV-Scope path: Install > Adjustment > Image Detection Subsystem > Camera Centring
2. Perform the BV-Scope window instructions (step 1 of 1).
Note: the text "For adjustment details see IDS manual" in the BV-scope window refers to the proce-
dure Adjustment details below.

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Adjustment details
1. Loosen the four clamping screws.

Fig. 122: Clamping screws

2. Turn the alignment eccentrics to the default po-


sition.

NOTICE
The arrows indicate in which direction the CLA
moves when you turn the alignment eccentric.

Fig. 123: Default position of alignment eccentrics

3. Install a phantom that has a centering cross in


front of the II assembly.
4. Generate a reference crosshair with the system.
5. Generate X-ray.
6. Mark the center of the cross on the viewing
monitor.
7. Determine where the X-ray cross is in relation to
the reference cross.
8. Proceed with the procedure 'Camera centre of
rotation'.

Fig. 124

4.2.4.3 Camera centre of rotation


This procedure is used to adjust the rotation of the camera and should be performed after replacement
of the IDS.

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Fig. 125: Install > Adjustment > Image Detection Subsystem > Camera Centre of Rotation panel (step 1 of 1)
1. Select BV-Scope path:Install > Adjustment > Image Detection Subsystem > Camera Centre of Rota-
tion
2. Perform the BV-Scope window instructions (step 1 of 1).

Adjustment details
3. Turn the eccentrics until the centers of the two
crosses are at the same position.

Fig. 126

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4. Turn the CLA around its axis to align the


crosses.
5. Tighten the four clamping screws.

NOTICE
Make sure that you do not change the alignment
when you tighten the four clamping screws.

Fig. 127

4.2.4.4 II diameter
This procedure is used to adjust the II entrance diameter to match it to the matrix size of the camera
CCD.

Fig. 128: Install > Adjustment > Image Detection Subsystem > II Diameter panel (step 1 of 1)
1. Select: Install > Adjustment > Image Detection Subsystem > II Diameter
2. Perform the BV-Scope window instructions (step 1 of 1).

NOTICE
The steps 2, 3 and 4 in figure 18 have to be performed simultaneously.

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4.2.4.5 Dose rate adjustment

Fig. 129: Install > Adjustment > Image Detection Subsystem > Dose Rate panel (step 1 of 2)
1. Select: Install > Adjustment > Image Detection Subsystem > Dose rate

Fig. 130: Install > Adjustment > Image Detection Subsystem > Dose Rate panel (step 2 of 2)
2. Perform the BV-Scope window instructions (step 1- 2).

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5 Testing

5.1 Definition
A critical examination, observation, or evaluation of such conditions or operations through testing pro-
cedures provided by the manufacturer that will prove the unit meets specifications.

5.2 Test procedures

5.2.1 X-ray field verification


5.2.1.1 Iris verification

NOTICE
Press <RESET SHUTTER MOVEMENT> or <RESET IRIS> for less than 0.5 seconds. The shutter/iris
indication is visualized at the monitor (SW programmed circle/line) without changing the actual setting.
Press <RESET SHUTTER MOVEMENT> or <RESET IRIS> for more than 0.5 seconds to reset the
setting to maximum.

In order to meet approval/approbation requirements the following requirements must be applied:


A) For image intensified fluoroscopy:
• At least 80 percent of the area of the X-ray field overlaps the visible area of the image receptor.
• Means shall be provided for step-less adjustment of the field size. The minimum field size, shall be
containable in a square of 5 cm by 5 cm measured on the II surface.

NOTICE
The visible area is representated by the electronic indication circle.

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Fig. 131: Deviation of the iris blades with respect to the indication circle
B) For spot film devices (radiography):
• Neither the length nor the width of the X-ray field in the plane of the image receptor shall differ from the
corresponding dimensions of the selected portion of the image receptor by more than 3% of the SID
when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard
to sign, of the length and width differences shall not exceed 4% of the SID.
• The center of the X-ray field in the plane of the image receptor shall be aligned with the center of the
selected portion of the image receptor within 2% of the SID.
• For spot-film devices used on fluoroscopy systems that have a step-less adjustment of the field size,
the minimum field size shall be equal or less than 5 cm (SID ≤ 100cm).
Notes:
• Visible area is represented by the electronic indication circle.
• The SID for the BV Family systems is fixed at 99.5cm. (2% ≥ 19.9 mm, 3% ≥ 29.88 mm and 4% ≥ 39.8
mm).
System specifications:
The following system specification covers the requirements for fluoroscopy and radiography.
1. The rejection limit for the maximum deviation of the iris blades with respect to the electronic indication
circle (see figure 'Deviation of the iris blades with respect to the indication circle') depends on the sys-
tem type and the II format, as shown in table 'Rejection limits maximum deviation between X-ray field
and indication circle').
2. Additional specification for radiography: maximum decentering is 14 mm (refer to the 'Procedure to
verify the requirements for spot film devices').

Rejection limits maximum deviation between X-ray field and indication circle
Detector format Rejection limit [mm]
BV Family 9" system BV Family 12" system
Large ≤7 ≤ 12

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Detector format Rejection limit [mm]


BV Family 9" system BV Family 12" system
Medium ≤7 ≤7
Small ≤7 ≤7

NOTICE
Before using, check the X-ray lead ruler on damages. If the ruler is damaged do not use it.

1. Use an X-ray lead ruler to measure deviations and attach it with tape on the image detector.
2. Set the C-arm to 0° angulation and 0° rotation position.
3. Switch OFF and ON the system (for a correct homing procedure and loading of the adjustment data).
4. Select largest detector format.
5. Perform auto fluoroscopy until stabilization.
6. Switch over to manual kV and increase the X-ray voltage with 5 kV.
7. Close the collimator iris until the complete iris is visible (figure 131 on page 97).
8. Just shortly press the |Reset Iris| button on the C-arm stand UI to make the indication circle visible.
9. Make sure that the largest deviation (figure 131 on page 97) between the X-ray field and the indica-
tion circle does not exceed the rejection limit listed in in the SRM. Record the largest deviation in
[mm].

NOTICE
Make sure that the lead ruler is in the correct position to measure the largest deviation, (figure 131
on page 97). If the lead ruler is not in the correct position, move the ruler to the position shown in the
figure and continue with step 5 of this verification.

10. Repeat step 4 to 9 for the other detector formats.


11. Keep the smallest detector format and close the collimator as far as possible.
12. Start fluoroscopy.
13. Use the X-ray lead ruler to measure the iris minimal field size. Verify that the field does not exceed 48
millimeter in every direction. Record the largest diameter in [mm].
Procedure to verify the requirements for spot film devices:
1. Position the C-arm so that the rotation is 90 degrees and the angulation is such that angulation is
minimal (tube housing against C-arm bearing).
2. Place a film or PCR in the cassette holder; take care the center of the film or PCR is in the middle of
the image detector.
3. Make an exposure (with appropriate settings) in "radiography / cassette mode" and measure with a
ruler the diameter and the deviation with respect to the expected center (middle of the film or PCR).
4. Verify both the diameter (should be 24 cm) deviation and decentering do not exceed 14 mm.

5.2.1.2 Shutter verification

NOTICE
Press <RESET SHUTTER MOVEMENT> or <RESET IRIS> for less than 0.5 seconds. The shutter/iris
indication is visualized at the monitor (SW programmed circle/line) without changing the actual setting.
Press <RESET SHUTTER MOVEMENT> or <RESET IRIS> for more than 0.5 seconds to reset the
setting to maximum.

To execute the shutter verification procedure:


1. Switch OFF and ON the system (for a correct homing procedure and loading of the adjustment data).
2. Select II format Large (F0).
3. Select <SHUTTER A> and move the shutter indication (yellow monitor line) ca. 3 cm inwards.

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4. Make a fluoroscopy image (start fluoroscopy LDF automatic).


5. Press <SELECT SHUTTER A> again.
6. Check if the shutter edge and its indication (yellow monitor line) have the same position.
7. Repeat the steps 3 to 6 for the most inward position of the shutter.
8. Repeat the steps 3 to 6 at a shutter rotation of +90 degrees.
9. Repeat the steps 3 to 8 for shutter B.
10. Repeat the steps 3 to 9 for all selectable detector formats (Medium detector format (F1) and Small
detector format (F2)).

5.2.2 Dose rate verification


To verify the dose rate, perform the following steps:
1. Make sure the grid has been mounted.
2. Remove all objects from the X-ray beam.
3. Put 1.5 mm Cu + 20 mm Al filter on the tank.
4. On the stand UI:
• Select examination type: Vascular
• Set X-mode to: Continuous fluoroscopy
In case no Vascular license is available, select Orthopaedics.
In case of a US system, select Orthopaedics and multiply the measured dose rates with factor 0.6.
5. On the stand UI:
• Set II format to: Large
6. Start LDF using left hand or footswitch until kV is stabilized. Press the switch twice to stabilize the
dose control algorithm.
7. Switch to kV manual mode.
8. Position the dose probe in the center of the II.
9. Press the left hand or footswitch for LDF fluoroscopy and measure the dose rate in nGy/s.
10. Record the dose rate value after at least 12 seconds radiation for future reference.
11. Remove the dose probe.
12. Repeat step 6-11 for the II formats medium and small.
13. Repeat step 5-12 for the HDF mode using the right hand or footswitch.
14. Only applicable for BV Pulsera systems, on the stand UI:
• Select examination type: Pacemaker
• Set X-mode to: Pulsed Exposure (9.5ms, 30pps)
• Set II format to: Large
• Do steps 5-12 and use HDF instead of LDF mode, using the right hand or foot switch (in step 9
measure dose rate in μGy/frame).

Dose rate fluoroscopy normal mode - 12" IDS systems


Mode II format Nominal dose rate Minimum dose rate Maximum dose rate
(nGy/s) (nGy/s) (nGy/s)
LDF F0 250 175 325
F1 300 200 400
F2 400 275 525
HDF F0 600 450 750
F1 720 540 900
F2 960 720 1200

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Dose rate fluoroscopy normal mode - 9" IDS systems


Mode II format Nominal dose rate Minimum dose rate Maximum dose rate
(nGy/s) (nGy/s) (nGy/s)
LDF F0 200 125 275
F1 300 200 400
F2 400 275 525
HDF F0 480 360 600
F1 720 540 900
F2 960 720 1200

Dose rate Pulsed Exposure 9”/12” IDS systems (BV Pulsera only)
Mode II format Nominal dose rate Minimum dose rate Maximum dose rate
(μGy/frame) (μGy/frame) (μGy/frame)
12” IDS sys- F0 0.051 0.038 0.064
tem F1 0.060 0.043 0.076
HDF
F2 0.074 0.052 0.096
9” IDS F0 0.042 0.028 0.055
system F1 0.059 0.042 0.076
HDF
F2 0.081 0.051 0.110

5.2.3 Dose indication verification


1. Remove all objects out of the X-ray beam.
2. Make sure that the grid is installed.
3. Place the dose probe on the grid.
4. Switch on the dose meter.
5. On the stand UI:
• Select examination type: Orthopedics
• Set II format to: Large
• Set X-mode to: Continuous
• Set kV/mA Auto/Manual to: Manual kV / Auto mA
• Set kV set to: 69
6. Start HDF (right hand- or foot switch), wait 12 seconds for the dose rate to stabilize:
• Read the dose rate value from the UI.
• Measure the dose rate with the dose meter.
7. Multiply the measured dose rate by 2.097.
8. Record both values, in mGy/min in the SRM.
9. Calculate the deviation, in %, between the corrected measured dose rate and the dose rate from the
UI of the C-arm stand. The result must be ≤ 10%.
Calculation method 1: use if the dose output from UI > dose output from dose meter.

Calculation method 2: use if dose output from dose meter > dose output from dose UI.

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10. On the stand UI:


• Set kV to maximal value.
11. Repeat step 6 until and including 9.
12. Remove the dose probe.
13. Switch off the dose meter.

5.2.4 X-ray tube performance test


5.2.4.1 Procedure for BV Endura
This verification procedure contains these stages:
1. Probe positioning
2. X-ray tube voltage verification for fluoroscopy (BV-Scope - step 1)
3. Only for systems with Radiography enabled: X-ray tube voltage verification for RAD (BV-Scope - step
2),
4. X-ray tube current verification for fluoroscopy and RAD (BV-Scope - step 3)

CAUTION
Before you start the X-ray tube performance test on a BV Enduran system with Radiography enabled,
make sure that fuses F1 and F2 on the WA1 board are 30A in case the mains voltage is 130V or low-
er.

Probe positioning
1. Install the 20cm spacer (IEC) if not already in-
stalled.

NOTICE
The 20cm spacer is delivered with the system. If
necessary, it can be ordered as a sparepart.

Fig. 132: 20cm spacer (IEC)

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2. Place the dose/kV probe at the 20cm spacer.

Fig. 133: Correct position of dose/kV probe

3. At the stand User Interface:


• Select kV manual
• Set kV to 72 kV
• Select Auto Contrast/Brightness on
4. Start HDF (right hand or footswitch) and verify
the image on the left monitor with the picture.
5. Move the probe in such a way that all measuring
fields of the probe are visible in the image.

Fig. 134: Example of correct image with all measuring


fields of the dose probe visible (e.g. Unfors Xi Platinum
dose probe in this case)

WARNING
X-ray hazard: This procedure requires maximum radiation. Considerable radiation leakage
from the X-ray tank will occur.
Take appropriate precautions to protect yourself and all other persons present against X-ray. Refer to
section chapter Radiation safety on page 20'.

X-ray tube voltage verification for fluoroscopy:


1. Select BV-Scope path:Install > Performance Test > X-ray tube performance.

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Fig. 135: X-ray tube voltage performance panel step 1 (BV Endura)
2. Follow the procedure as described in BV-scope.

X-ray tube voltage verification for RAD

Fig. 136: X-ray tube voltage performance panel step 2 (BV Endura) (Example image without the High Power Rad
option)

NOTICE
The X-ray tube voltage performance panel step 2 (BV Endura) looks different if High Power RAD is
active. In this case, an additional step is present between step 1 and step 2.

1. Follow the procedure as described in BV-scope.

X-ray tube current verification for fluoroscopy and RAD


1. Remove the dose/kV probe.
2. If applicable reinstall the original spacer

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3. Place a lead plate on top of the diaphragm cov-


er (X-ray protection).

Fig. 137: Lead plate on diaphragm cover

Fig. 138: X-ray tube voltage performance panel step 3 (BV Endura)
4. Follow the procedure as described in BV-scope.

Verification limits of X-ray tube Voltage for fluoroscopy


Fluo setting Voltage setting (kV) Rejection limits
LDF 40 ± 2.5 kV
LDF 75 ± 5.3 kV
LDF 110 ± 7.4 kV
HDF 110 ± 7.4 kV

Verification limits of X-ray tube Voltage for RAD


RAD setting Voltage setting (kV) Rejection limits
Exposure 80 mAs - 40 kV 40 ± 3.2 kV
Exposure 80 mAs - 75 kV 75 ± 5.3 kV
Exposure 80 mAs - 105 kV 105 ± 7.1 kV
Exposure 3.2 mAs - 105 kV 105 ± 7.1 kV
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Verification limits of X-ray tube filament current for fluoroscopy


Tube voltage (kV) Filament current setting (mA) Rejection limits
40 0.10 ± 4.5%
75 2.77 ± 4.5%
110 3.00 ± 4.5%
110 7.20 ± 4.5%

Verification limits of X-ray tube filament current for RAD


RAD Setting Filament current setting (mA) Rejection limits
40 kV - 80mAs 20 ± 8.5%
75 kV - 80mAs 20 ± 8.5%
105 kV - 80mAs 20 ± 8.5%
105 kV - 3.2 mAs 30 ± 8.5%
If the X-Ray tube performance test fails, chapter X-ray tube performance test failed BV En-
dura on page 108.

5.2.4.2 Procedure for BV Pulsera


This procedure verifies the filament adjustment procedure of the BV Pulsera system.

WARNING
X-ray hazard: This procedure requires maximum radiation. Considerable radiation leakage
from the X-ray tank will occur.
Take appropriate precautions to protect yourself and all other persons present against X-ray. Refer to
section chapter Radiation safety on page 20'.

5. Place a lead plate on top of the diaphragm cov-


er (X-ray protection).

Fig. 139: Lead plate on X-ray tank

6. Select BV-Scope procedure Install > Performance Test > X-ray tube performance.
7. Perform the BV-Scope window instructions.

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Fig. 140: Install > Performance Test > X-ray Tube Performance panel (Example image without the High Power
Rad option).
8. If the X-ray tube performance test is not successful repeat the test once.
9. Remove the lead plate.
If the X-Ray tube performance test fails, chapter X-ray tube performance test failed BV Pul-
sera on page 109.

X-ray tube potential and current rejections limits in fluoroscopy and radiography mode for BV Pulsera
Mode Tube potential [kV] Tube current [mA]
Default Min Max Default Min Max
Normal LDF SF 40.0 37.6 42.4 0.10 0.087 0.113
Normal LDF SF 75.0 71.2 78.8 1 2.77 2.625 2.915
Normal LDF SF 120.0 114.4 25.6 3.00 2.845 3.155
ISO HDF SF 40.0 37.6 42.4 0.80 0.752 0.848
ISO HDF SF 72.0 68.32 75.68 19.99 18.984 20.996
ISO HDF SF 100.0 95.2 104.8 14.40 3.674 15.126
ISO HDF SF 120.0 114.4 125.6 12.00 11.395 12.605
Normal LDF LF 40.0 37.6 42.4 0.10 0.087 0.113
Normal LDF LF 75.0 71.2 78.8 2.77 2.625 2.915
Normal LDF LF 120.0 114.4 125.6 3.00 2.845 3.155
HC HDF 1/2 dose 48.0 45.28 50.72 1.28 1.128 1.432
HC HDF 1/2 dose 61.0 57.76 64.24 5.29 4.658 5.922
HC HDF 1/2 dose 90.0 85.6 94.4 11.48 10.106 12.854
N LDF 1/4 dose 48.0 45.28 50.72 1.28 1.128 1.432
N LDF 1/4 dose 61.0 57.76 64.24 5.29 4.658 5.922
N LDF 1/4 dose 90.0 85.6 94.4 11.48 10.106 12.854

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Mode Tube potential [kV] Tube current [mA]


Default Min Max Default Min Max
ISO HDF LF 40.0 37.6 42.4 0.80 0.752 0.848
ISO HDF LF 72.0 68.32 75.68 19.99 18.983 20.997
ISO HDF LF 100.0 95.2 104.8 14.40 13.674 15.126
ISO HDF LF 120.0 114.4 125.6 12.00 11.395 12.605
N / HC DIGRAD 48.0 45.28 50.72 4.80 4.226 5.374
N / HC DIGRAD 61.0 57.76 64.24 19.83 17.453 22.207
N / HC DIGRAD 90.0 85.6 94.4 43.05 37.888 48.212
ISO DIGRAD 52.0 49.12 54.88 17.40 15.314 19.486
ISO DIGRAD 67.0 63.52 70.48 68.70 60.459 76.941
ISO DIGRAD 90.0 85.6 94.4 60.03 52.830 67.230
PULSED 3 Frames/s 48.0 45.28 50.72 6.40 5.634 7.166
PULSED 3 Frames/s 61.0 57.76 64.24 26.44 23.270 29.610
PULSED 3 Frames/s 90.0 85.6 94.4 57.40 50.516 64.284
PULSED 30 Frames/s 48.0 45.28 50.72 6.40 5.634 7.166
PULSED 30 Frames/s 61.0 57.76 64.24 26.44 23.270 29.610
PULSED 30 Frames/s 90.0 85.6 94.4 57.40 50.516 64.284
PULSED Generic 48.0 45.28 50.72 6.40 5.634 7.166
PULSED Generic 61.0 57.76 64.24 26.44 23.270 29.610
PULSED Generic 90.0 85.6 94.4 57.40 50.516 64.284
Film Rad 48.0 45.28 50.72 60.00 55.800 64.200
Film Rad 61.0 57.76 64.24 60.00 55.800 64.200
Film Rad 90.0 85.6 94.4 60.00 55.800 64.200
High Power Rad (option) 100.0 95.2 104.8 125.00 116.25 133.75
High Power Rad (option) 120.0 114.4 125.6 125.00 116.25 133.75

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5.2.5 X-ray tube performance test failed


5.2.5.1 X-ray tube performance test failed BV Endura

Fig. 141: Flowchart X-ray tube performance test failed BV Endura


If for BV Endura systems the X-ray tube performance test fails do the following X-ray tube adjustments
in BV Scope again:
1. Voltage adjustment
2. Filament adjustment (only for systems with Radiography enabled)
When the X-ray tube performance test fails three times, check the system for other defects.

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5.2.5.2 X-ray tube performance test failed BV Pulsera

Fig. 142: Flowchart X-ray tube performance test failed BV Pulsera


1. Select Fault finding > Logging > Logfile Complete System. A logfile appears.
2. Click |CLICK HERE TO PROCEED TO THE END OF LOGGING|.
3. From the end of the logging, scroll up to search for the verification table, see table 'Verification table -
Example' for an example.

NOTICE
If in the fields LF HC 1/2 dose, LF N LDF 1/4 dose or LF N/HC 12 mA and L.F.Normal / HC DIGRAD,
Pulsed, L.F.Normal Rad and High Power Rad (system option), the message PASSED appears, the
procedure below is not applicable: click the OK button.

4. Look in the Verification table in the rows with the modes LF HC 1/2 dose, LF N LDF 1/4 dose or LF
N/HC 12 mA and L.F.Normal / HC DIGRAD, Pulsed, L.F.Normal Rad and High Power Rad (system
option). If in the columns mAdrift or mAstable an asterisk (*) is added to a measured value. See table
'Verification table - Example' for an example.
5. If an asterisk is added, the status is FAILED (see column status). Keep in mind whether the corre-
sponding measured value is negative or positive. Click |OK|.
6. If the value marked with an (*) is negative, add +0.05mA to the measured mA actual value of step 11
from chapter 'Filament gain BV Pulsera'.
7. If the value marked with an (*) is positive, subtract -0.05mA to the measured mA actual value of step
11 from chapter 'Filament gain BV Pulsera'.
8. If the procedure is not succesful:
• repeat Calibration reset

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• repeat the Filament gain adjustment and use the calculated mA value in step 11.
• Repeat the Filament adjustment
• Repeat the X-ray tube performance test

Verification table - Example


setpoint measured
kV mA kVact mAdrift mAstable mAact status mode
40.0 0.100 40.3 0.10 PASSED S.F. Normal LDF
75.0 2.77 74.7 2.78 PASSED S.F. Normal LDF
120.0 3.00 119.9 3.00 PASSED S.F. Normal LDF
40.0 0.8 39.6 0.81 PASSED S.F. ISO HDF
72.0 19.99 70.3 20.02 PASSED S.F. ISO HDF
100.0 14.40 99.2 14.43 PASSED S.F. ISO HDF
120.0 12.00 119.0 12.04 PASSED S.F. ISO HDF
40.0 0.80 39.7 0.78 PASSED L.F. ISO HDF
72.0 19.99 71.1 20.02 PASSED L.F. ISO HDF
100.0 14.40 98.9 14.40 PASSED L.F. ISO HDF
120.0 12.00 118.9 11.99 PASSED L.F. ISO HDF
48.0 4.48 48.1 -0.524* 4.85 FAILED L.F. Normal / HC DI-
GRAD
61.0 19.83 60.6 -0.871 20.19 PASSED L.F. Normal / HC DIGRAD
90.0 43.05 89.5 -0.147 43.30 PASSED L.F. Normal / HC DIGRAD
48.0 60.00 47.8 -1.685 59.121 59.93 PASSED L.F. Normal RAD
61.0 60.00 60.2 -0.513 59.560 60.07 PASSED L.F. Normal RAD
90.0 60.00 89.3 -0.623 59.048 59.74 PASSED L.F. Normal RAD
100.0 125.00 100.8 2.848 123.075 121.71 PASSED L.F. High Power RAD
120.0 125.00 121.4 3.519 128.592 126.83 PASSED L.F. High Power RAD

NOTICE
In case of a 3D-RX option, move away the 3D-RX interface unit to access the potmeter on SEA3.

5.2.6 Maximum patient entrance dose rate verification


The maximum patient entrance dose is in many countries limited by law. The maximum output of the
BV Family system meets the American HHS regulations. To ensure a BV Family system operates ac-
cording to local regulations of other countries, it is possible to limit the maximum possible dose output
of the system.
In order to meet the approval/approbation requirements for HHS, the maximum exposure rate at any
combination of tube voltage and current must be less than 10 R/min. Two exceptions are allowed:
• During recording of images using a video camera, when the X-ray source is used in pulsed mode with
a duration less than one half second.
• When High Definition Fluoroscopy is activated, indicated by a continuous audible signal, the maximum
exposure rate at any combination of tube potential and current should be less than 20 R/min.
The BV Family system is allowed to produce up to 90% (=Rejection limit) of the maximum permitted
patient entrance dose. The measuring instrumentation should therefore have a combined accuracy <=
10%.

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Maximum patient entrance dose rate BV Family systems


X-ray Mode HHS requirements Rejection limits (HHS - 10%)
LDF 10 R/min = 1456 μGy/s 9.0 R/min = 1309 μGy/s
HDF 20 R/min = 2912 μGy/s 18.0 R/min = 2619 μGy/s
Digital exposure (BV Pulsera 326 mR = 2848 uGy1)
only)
Pulsed exposure (BV Pulsera) 20 R/min = 2912 μGy/s 18.0 R/min = 2619 μGy/s
1)
45.0 R/min (= 6548 μGy/sec) and with 435 ms pulse width

Procedure for BV Endura


1. Place a lead phantom on the II.
2. Place the probe of the dosimeter in the center of the X-ray beam at a distance of 30 cm from the II.
Diaphragm and shutters must be fully open.
3. Set the system in auto mode.
4. Start LDF. The system will enter HIP mode.
Verify that the dose rate reading of the dosimeter is less than the corresponding rejection limit in table
'Maximum patient entrance dose BV Family systems'.
5. Start HDF and verify that the dose rate reading of the dosimeter is less than the corresponding rejec-
tion limit in table 'Maximum patient entrance dose BV Family systems'.
Check that the audible signal is present.

Procedure for BV Pulsera


1. Place a lead phantom on the II.
2. Place the probe of the dosimeter in the center of the X-ray beam at a distance of 30 cm from the II.
Diaphragm and shutters must be fully open.
3. Set the system in auto mode.
4. Select the first examination type on the stand UI.
5. If LDF is available in this examination, start LDF in continuous mode and verify that the dose rate
reading of the dosimeter is less than the corresponding rejection limit in table 'Maximum patient en-
trance dose BV Family systems'.
6. If HDF is available in this examination, start HDF in continuous mode and verify that the dose rate
reading of the dosimeter is less than the corresponding rejection limit in table 'Maximum patient en-
trance dose BV Family systems'.
Check that the audible signal is present.
7. If Pulsed Exposure is available in this examination, do the following:
• Start Pulsed Exposure with maximum pulse rate and verify that the dose rate reading of the dosime-
ter is less than the corresponding rejection limit in table 'Maximum patient entrance dose BV Family
systems'.
Check that the audible signal is present.
• Start LDF (left button) with maximum pulse rate and verify that the dose rate reading of the dosime-
ter is less than the corresponding rejection limit in table 'Maximum patient entrance dose BV Family
systems'
8. If Digital Exposure is available in this examination, do the following:
• Press the left hand or footswitch for LDF fluoroscopy during 5 seconds to adjust the system and ver-
ify that the dose rate reading of the dosimeter is less than the corresponding rejection limit in table
'Maximum patient entrance dose BV Family systems'.
• Start Digital Exposure and verify that the dose reading of the dosimeter is less than the correspond-
ing rejection limit in table 'Maximum patient entrance dose BV Family systems'.
Check that the audible signal is present.
9. Repeat step 4 until and including 8 for each examination.

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5.2.7 Electrical Safety

5.2.7.1 Electrical safety measurements according IEC-62353


This section describes the necessary measurements for IEC62353. These procedures are applicable
for mobile X-ray devices during:
• Installation
• Corrective maintenance
• Planned maintenance
1. Do a visual inspection:
• Make sure that the value of the fuses matches with the inscription.
- Only examine the values for the fuses that are accessible after removing the MVS covers.
• Examine the integrity of mechanical parts.
- Make sure that there is no damage or contamination.
• Make sure that the safety-related labels are present and readable.
• Check the relevant accessories on deviations.
• Check whether the required documents (IFU) are present and reflect the current revision of the sys-
tem.
• After testing, repair, or adjustment, make sure that the equipment is restored to the conditions that
are necessary for clinical use.
2. Use a tool that is qualified to perform measurements according to IEC-62353.
3. Measure the protective earth resistance, according to IEC-62353.
4. Measure the equipment leakage current according to IEC-62353. For mobile X-ray devices this con-
sists of the following 2 measurements:
• the earth leakage current measurement, according to IEC-62353.
• touch current measurement, according to IEC-62353.
5. When a safety test fails, mark the BV Family system as unsafe

5.2.7.2 Safety test Mains Control Unit


This test must be done after the Mains Control Unit has been replaced:
1. Power ON the MVS.
2. Disconnect the cable between MVS and C-arm
stand.
3. Make sure that there is no voltage between the
pins SAX1:1 and SAX1:2 of the C-arm stand-
MVS cable connector.
4. Make sure that there is no voltage between the
pins SAX1:3 and SAX1:4 of the C-arm stand-
MVS cable connector.

Fig. 143: Measurement points SA-X1

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When a safety test fails, mark the BV Family system as unsafe.

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BV Family Release 2.3

6 Installation

6.1 Definition
To set up for use by verifying that proper assembly and adjustments were made to assure compliance
with federal performance specifications.

6.2 Introduction
A number of performance checks must be done to make sure that the BV Family system is functioning
properly and within the specification(s).

6.3 The scope of the checks

NOTICE
The function of all operator controls and indicators are described in the Instructions for Use.

The performance check program is defined as follows:


1. Mechanical movement checks (refer to section 'Mechanical checking')
2. Functional tests (refer to section 'Functional testing')
Performance testing has been done already in the factory. A full status report is supplied together with
each individual BV Family system (see System Reference Manual, chapter "Record or measured da-
ta").

6.4 Required tools and test equipment


To carry out the performance checks, a standard tool kit (chapter Standard Toolkit on page 9) and a
service PC (chapter Service PC on page 11) are required.

6.5 Performance checks

6.5.1 Mechanical checking


The following mechanical movements have to be checked. After checking, mark the applicable check-
box of the list in the System Reference Manual

Mechanical movement checks - Overview


Check Description
Rotation Check the functioning: beyond +/- 180°, safety stop at 135° and
-135°
Angulation Check the functioning: +90°/-25° (+90°/-45° for extended rotation)
Motorized height movement Check the functioning: +43 cm/-6 cm +41 cm/-8 cm (for extended
rotation)
Longitudinal movement Check the functioning: 20 cm
Panning movement Check the functioning: +/- 10°
Parallel movement Check the functioning
Locks Check the functioning

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Check Description
All mechanical stops Check the functioning
Wheels, wheel alignment and Check the functioning
cable deflectors
LCD height adjustment MVS (op- Check the functioning
tional)
Folding of LCD monitors incl. end Check the functioning
click
C-arm angulation lock (for systems Check the functioning
with 3D-RX option)
C-arm movements are shown in the figures below.

Fig. 144: C-arm rotation (left) and angulation (right)

Fig. 145: C-arm vertical (left) and longitudinal (right) movement

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Fig. 146: C-arm panning (left) and parallel (right) movement

6.5.2 Functional testing


The following functional checks have to be done. After checking, mark the applicable checkbox of the
list in the System Reference Manual.

Functional checks - Overview


Check Description
Accessories Availability and integrity
Cable deflectors Check for presence and damage
Brakes, wheels, steering Ensure correct functioning
Cabling Inspect all cables for kinks and/or cracks
Controls and indicators check Check for correct functioning
Connectors Check correct connection and damage of hand switch connector
Check correct connection and damage of foot switch connector
Check correct connection and damage of stand-trolley cable con-
nector
Power-on Check display and monitor for error messages
X-ray Ensure correct functioning (refer to section 'X-ray control function
test')
Check collimator iris settings and verify shutter positions
Check the correct functioning of the system lock
Check radiography
Energy storage unit (Pulsera only) Check for battery charge warning message

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Check Description
Hand switch Check for damage and correct functioning
Foot switch Check for damage and correct functioning
Height movement (C-arm stand) Check for correct functioning
Mobile viewing station Ensure correct functioning of the monitors
USB storage device Check for damage and correct functioning
Remote control (optional) Check for damage and correct functioning
Laser alignment tool (collimator) Check for correct alignment
Laser alignment tool (II) (optional) Check for correct alignment
Printer (optional) Check for correct functioning and paper/ transparency presence
Medical DVD-Recorder (optional) Check for correct functioning/DVD+RW presence
Fan Check for damage and correct functioning
ViewForum (optional) Check for damage and correct functioning
3D-RX workstation (for systems Check for damage and correct functioning
with 3D-RX option)
3D-RX handswitch (for systems Check for damage and correct functioning
with 3D-RX option)
3D-RX laser (for systems with 3D- Check for damage and correct functioning
RX option)
A number of functional tests indicated in the table above can be found in detail in the following sec-
tions.

6.5.3 Key test


To execute a key test:
1. Select Install > Performance Test > Key Test
2. Perform the BV-Scope window instructions (semi-automatic).
3. Press a key and make sure that the "Key Pressed" field displays the ‘key name’ at the moment that
the key is pressed. It displays “NONE” when all keys are released.
4. Release a key and make sure that the "Key Released" field displays the released “key name”. It dis-
plays “NONE” at the moment that any key is pressed.

Fig. 147: Install > Performance Test > Key Test panel

6.5.4 Laser alignment tool check


The laser alignment tool (LAT) check must be done daily.
5. Make sure that the alignment of the Laser Alignment Tool is correct:
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• Turn the laser on by pressing the |LAT on/off| key.


• Make sure that the laser cross coincides with the key hole symbol on the grid of the II.

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List of Abbreviations

AC Alternating current
AIAT Assembly, Installation, Adjustment and Testing
BV-Scope Service control operating environment.
CCD Charge Coupled Device
CFR Code of Federal Regulations
DC Direct current
EFRP Engineer's Form to Return Parts
EMC Electro Magnetic Compatibility
ESD Electro Static Discharge
ESD Electrostatic Discharge
FDA Food and Drug Administration
FSE Field Service Engineer
HDF High Definition Fluoroscopy
HF High frequency
HHS Health & Human Services (United States office for HHS)
HIP High Penetration
ICRP International Commission on Radiological Protection
IEC International Electrotechnical Commision
II Image Intensifier (detector)
IP Internet Protocol
LAN Local Area Network
LAT Laser Alignment Tool
LCD Liquid Crystal Display
LDF Low Dose Fluoroscopy
LIH Last Image Hold
MVS Mobile Viewing Station
NCRP National Council on Radiological Protection
PC Personal Computer
PCB Printed Circuit Board
SCPU Stand control & power unit
SRM System Reference Manual
UI User Interface

my_pagecount_text
US United States of America

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