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Service Manual BV Family R1.

SERVICE MANUAL - SYSTEM: BV Family RELEASE 1.2 General Information


SYSTEM: BV Family
TYPE NO:

Manual Code Number 4522 981 22614 Date: 15-march-2005

LIST OF PAGES and DRAWINGS

0.5 (03.0)
1 (03.0)
2.1 (05.0) *

SM-G 1-1 … 2 (04.0)

SM-G 2-1 … 20 (05.0) *

SM-G 3-1 … 6 (03.0)

BV Family R1.2 / Volume 1 (05.0) SM – G 2.1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
PHILIPS
PHILIPS TABLE OF CONTENT 1 ➤

GENERAL
INTRODUCTION
2 ➤

PHILIPS MEDICAL SYSTEMS


GLOSSARY 3 ➤

General IInformation
General nformation
4 ➤

5 ➤

6 ➤

7 ➤

8 ➤

9 ➤

PMSN Best

Reproduction in whole or in part is prohibited without the written consent of 10 ➤


the copyright owner. Use of the information contained herein in any form
and/or by any means whatsoever is strictly reserved for Philips and its
licencees. Use of this manual by unauthorised persons is strictly prohibited.

Printed in Best, The Netherlands.

BV Family R1.2 / Volume 1 (03.1) SM - G 1


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 1
Table of Content

Section 1 TABLE OF CONTENT

Contents

VOLUME 1

System Manual General Information [SM-G]

Section 1 - Table of Content


Section 2 - General Introduction
Section 3 - Glossary

System Manual Installation [SM-I]

Section 1 - Technical data


Section 2 - Order config & Delivery sheet
Section 3 - Unpacking instructions
Section 4 - Installation instructions
Section 5 - Setting to Work procedure
Section 6 - Performance check programme
Section 7 - Hand-over procedure
Section 8 - Customizing the BV Family System
Section 9 - Record of measured data
Section 10 - Modifications

System Manual Software [SM-SW]

Section 1 - Software installation


Section 2 - BV-Scope menu items
Section 3 - DICOM configuration

System Manual Corrective Maintenance [SM-CM]

Section 1 - Introduction
Section 2 - System overview [not applicable]
Section 3 - Fault finding procedures
Section 4 - Replacement procedures
Section 5 - Adjustment & Verification
Section 6 - Image performance checks
Section 7 - Drawings MVS & CAS
Section 8 - Spare parts

BV Family R1.2 / Volume 1 (04.0) SM-G 1 - 1


Copyright © 2004 Koninklijke Philips Electronics N.V.
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Section 1 Service Manual BV Family R1.2
Table of Content

VOLUME 2

System Manual PEI units

[Universal] Mains control unit

[iXion] Monoblock
[iXion] HF generator
[iXion] Energy storage unit

HT converter tank
X-ray beam collimator
XTV-8 camera
12” II/TV sub-system
9” II/TV sub-system
9” Basic lens assembly
Shield for 9” II-tube
HT generator for 9” II-tube
6” II/TV sub-system
6" Tube assy
6" Basic lens assembly
6" II compact generator

System Manual Options

Laser alignment tool


VCR / Paper printer
VCDR
System lock
Remote control

System Manual Accessories

Detachable cassette holder 6”


Detachable cassette holder 9”
Detachable cassette holder 12"

SM-G 1 - 2 (04.0) BV Family R1.2 / Volume 1


Copyright © 2004 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

Section 2 GENERAL INTRODUCTION

Contents

1 INTRODUCTION .....................................................................................................................................3
1.1 Intended Use of this manual ....................................................................................................................3

2 CONFIGURATION MANAGEMENT: PMS RELEASE & VERSION POLICY........................................4

3 SERVICE INFORMATION.......................................................................................................................5
3.1 The BV Family Systems ..........................................................................................................................5
3.2 Qualified personnel..................................................................................................................................5
3.3 Service Documentation............................................................................................................................5
3.3.1 Standard documentation ......................................................................................................................5
3.3.2 Changes to service documentation......................................................................................................5
3.4 Training ....................................................................................................................................................6
3.5 Intranet for Service Information ...............................................................................................................6
3.6 The HelpDesk ..........................................................................................................................................6
3.7 Standard service kit “Tools and Test equipment” ....................................................................................7
3.7.1 Null modem cables...............................................................................................................................8
3.7.2 Ethernet Cables & Ethernet Cross Cables...........................................................................................8
3.8 Special tools and phantoms kit ..............................................................................................................10
3.8.1 Special tools .......................................................................................................................................10
3.8.2 Phantoms kit.......................................................................................................................................10
3.8.3 Consumables .....................................................................................................................................10
3.9 Installation of the Service PC.................................................................................................................10

4 SAFETY.................................................................................................................................................11
4.1 Introduction ............................................................................................................................................11
4.2 Emergency procedures..........................................................................................................................11
4.3 Safety Directions....................................................................................................................................11
4.3.1 Electrical safety ..................................................................................................................................11
4.3.2 Transportation safety .........................................................................................................................13
4.3.3 Mechanical safety ..............................................................................................................................13
4.3.4 Explosion safety .................................................................................................................................13
4.3.5 Fire safety...........................................................................................................................................13
4.3.6 Electromagnetic compatibility [EMC] .................................................................................................13
4.3.7 Mobile telephones & similar products ................................................................................................13
4.3.8 Radiation safety & guidelines.............................................................................................................14
4.3.9 Laser light radiation safety .................................................................................................................15
4.3.10 Safety label positioning ......................................................................................................................15

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

5 AUTHORIZATION .................................................................................................................................16
5.1 Software License Agreement.................................................................................................................16
5.2 Protection policy.....................................................................................................................................16
5.3 Hardware-Key Consignment Agreement...............................................................................................17
5.4 BV Family authorisation table ................................................................................................................17
5.4.1 Administrator level..............................................................................................................................17
5.4.2 Service level .......................................................................................................................................18

6 LOGISTICS BV FAMILY SYSTEMS.....................................................................................................19


6.1 System documentation ..........................................................................................................................19
6.1.1 Instructions for Use ............................................................................................................................19
6.1.2 Service Manual ..................................................................................................................................19
6.1.3 IQ performance manual .....................................................................................................................19
6.1.4 Planned maintenance manual............................................................................................................19
6.2 System software ....................................................................................................................................20
6.2.1 Application software delivery..............................................................................................................20

SM-G 2 - 2 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

1 INTRODUCTION

1.1 INTENDED USE OF THIS MANUAL

The set up of this Service Manual is changed. More and more the BV Family R1.2 Systems have been
composed of at sub-system level instead of at component level.
The consequences are that the possibilities to perform service and/or maintenance of the system(s) are
changed. The set up of the Service Manual has been adapted accordingly.

Approximately 80% of the field service activities could be performed by qualified FSEs. PMS tool specialists
have selected a standard service kit “Tools & Test equipment”. The standard service kit, of which the content
is specified in this Section “General Introduction”, is required for service and sufficient for the normal daily
service. Apart from the - also specified - special tools and phantom kit, no other standard tools and test
equipment are required for field service.

For the remaining 20% of the field service activities the FSEs have to address their (field) issues directly to the
central X-ray Helpdesk.

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 3


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

2 CONFIGURATION MANAGEMENT: PMS RELEASE & VERSION


POLICY

SPECIAL NOTE

A strict release [and version] policy governs the releases of the BV Family R1.2 Systems. The various
hardware sub-systems and software tools & applications do have autonomous development(s). For this
reason it is unavoidable to maintain separate releases [and versions] for either hardware or software.
________________

SM-G 2 - 4 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

3 SERVICE INFORMATION

3.1 THE BV FAMILY SYSTEMS

The BV Libra, BV Endura and BV Pulsera are members of the PHILIPS BV Family R1.2 Systems. The BV
Family R1.2 Systems are a range of mobile diagnostic image acquisition and viewing systems. It is designed
for medical use in surgical theatres, where their unique maneuverability and imaging qualities make it ideal for
use in various application areas.

NOTE

This Service Manual contains the relevant information for field service and maintenance for the BV Libra /
BV Endura / BV Pulsera.
________________

3.2 QUALIFIED PERSONNEL

The Service Manual is intended for qualified and trained FSEs, who are involved in the servicing of
professional and sophisticated medical X-ray systems, in particular the PHILIPS BV Family R1.2 Systems.

3.3 SERVICE DOCUMENTATION

The service documentation comprises several manuals and documents, which are required for the proper
servicing during the life cycle of the system.

3.3.1 Standard documentation

Factory delivered systems and system transfers (product disposal) shall be accompanied by a full set of
standard documentation. The standard documentation comprises Instructions for Use and a Service Manual.

For a full listing of BV Family R1.2 System [service] documentation refer to chapter 6.1.

3.3.2 Changes to service documentation

To complete the service documentation, the following documents will be issued.

For changes:
• in delivery, a dedicated kit document;

For delta’s:
• both for corrections and for security aspects, a Field Change Order (FCO);

For software changes:


• bugs as well as major changes/developments, a BV Family R1.2 System Release Bulletin.

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 5


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

3.4 TRAINING

To maintain and/or to improve the quality level of field service, the FSEs should be trained adequately. These
trainings could take place at the Professor Holst Center of Philips Medical Systems Nederland B.V. in Best.
The address of the Center:
Professor Holst Center for Training and Education
Philips Medical Systems Nederland B.V.
P.O. Box 10 000
5680 DA Best, the Netherlands
Telephone: +31 40 276 2001
Fax: +31 40 276 3900

E-mail address:phc.planning@philips.com

3.5 INTRANET FOR SERVICE INFORMATION

To support the activities, PMS operates an intranet website for extensive information regarding medical
systems.

3.6 THE HELPDESK

There are separate helpdesks per region. In case of questions or problems, contact the helpdesk in your
region. If this helpdesk cannot help you, the centralized helpdesk of PMS is available for the Surgery X-ray
systems installed. Address:

Philips Medical Systems Nederland B.V.


Helpdesk X-ray
Building QG 150
P.O. Box 10 000
5680 DA Best, the Netherlands
Telephone: +31 40 276 4777
Fax: +31 40 276 2628

E-mail address:helpdesk.xray.best@philips.com

SM-G 2 - 6 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

3.7 STANDARD SERVICE KIT “TOOLS AND TEST EQUIPMENT”

For (initial) installation, setting to work, performance checks, planned maintenance and corrective
maintenance (i.e. fault finding, replacement and adjustment & verification of service parts) the following tools
and test equipment are required.
The content of the standard service kit, with the specifications and 12 NC numbers of the respective tools and
test equipment are given in ToolCodes and described in a tool catalogue at the intranet [ToolCode] website.
This tool catalogue can be downloaded.

Standard service kit [tools] ToolCode


1. Tool Kit, standard TC 129
2. ESD protection service kit TC 030
3. Earth bonding tester TC 025
4. Multimeter TC 091
5. Filter holder, flexible TC 047
6. Phantom holder, universal TC 097

Standard service kit [test equipment] ToolCode


7. Dose meter TC 142
8. Oscilloscope TC 095
9. Light meter TC 078

Standard Service PC ToolCode


10. Service PC TC 092
(Minimum) PC requirements:
- processor: Pentium III
- display: VGA
- storage: 6 Mb free hard disk space; 64 Mb RAM; CD-Rom drive;
3.5” 1.44 MB floppy disk drive
- MS-Windows Windows 2000
- I/O: 1 free serial port (V24); 1 parallel port; 1 Ethernet port; USB port
- mouse or track ball;
11. PC connector [null modem cable] 9 pins connector female; cable 9 wires (max) + earthing
12. PC Connector [cross cable] RJ45 male Ethernet cable
13. HW-key toolbox

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 7


Copyright © 2005 Koninklijke Philips Electronics N.V.
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Section 2 Service Manual BV Family R1.2
General Introduction

3.7.1 Null modem cables

Null modem cables are another type of serial cable used to connect printers, terminals, and other devices.
Null modem cable wires are attached to the pins in the connectors differently from how they are attached in a
modem cable. Connect the system end of the null modem cable to one of the system's serial ports.

As an alternative, you can make a null modem cable. Simply connect a null modem converter to a modem
cable and connect the null modem converter to one of the system's serial ports.
The serial null modem cable is designed for devices that send and receive data on the same pins. Terminals
are DTE devices, which expect to send data on pin 2 and receive it on pin 3. Because both devices are trying
to send and receive on the same wire, these wires must be crossed.

The "NULL MODEM CABLE" is specified as follows:

D-Sub 1 D-Sub 2

Receive Data 2 3 Transmit Data


Transmit Data 3 2 Receive Data
Data Terminal Ready 4 6+1 Data Set Ready + Carrier Detect
System Ground 5 5 System Ground
Data Set Ready + Carrier Detect 6+1 4 Data Terminal Ready
Request to Send 7 8 Clear to Send
Clear to Send 8 7 Request to Send

3.7.2 Ethernet Cables & Ethernet Cross Cables

Cross cables are another type of Ethernet cable. They are both used to connect printers, terminals, and other
devices. In case of a cross cable on one side of the cable, the pins in the connector are connected differently
when compared to an Ethernet cable.
An alternative to a cross cable is to connect a converter to an Ethernet cable and connect the Ethernet
converter to one of the system's Ethernet ports.

The Cross-cable is designed for devices that send and receive data on the same pins. That means that
white/orange cable connected to NIC 1 pin 1 should go to NIC 2 pin 3 and NIC 1 pin 2 to NIC 2 pin 6 etc. See
table below. Because both devices are trying to send and receive on the same wire, these wires must be
crossed.

(1000Base-T names in parentheses)

NIC1 NIC2
Name Color Name
pin no. pin no.
TX+ (BI_DA+) 1 White/Orange 3 RX+ (BI_DB+)
TX- (BI_DA-) 2 Orange 6 RX- (BI_DB-)
RX+ (BI_DB+) 3 White/Green 1 TX+ (BI_DA+)
- (BI_DC+) 4 Blue 7 - (BI_DD+)
- (BI_DC-) 5 White/Blue 8 - (BI_DD-)
RX- (BI_DB-) 6 Green 2 TX- (BI_DA-)
- (BI_DD+) 7 White/Brown 4 - (BI_DC+)
- (BI_DD-) 8 Brown 5 - (BI_DC-)

SM-G 2 - 8 (05.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 2
General Introduction

Ethernet cable Cross cable

Blue
White/Blue

White/Brown

Brown

NOTE

It is important that each pair is kept as a pair. TX+ & TX- must be a pair, and RX+ and RX- must be together in
another pair. (Just as the table above shows).
________________

NOTE

While 10Base-T and 100Base-TX only uses 2 pairs, for 100Base-T4 and
100Base-TX connect all 4 pairs.
________________

NOTE

The colors originate from the numbering and name on NIC1.


________________

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 9


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

3.8 SPECIAL TOOLS AND PHANTOMS KIT

3.8.1 Special tools

Special tools ToolCode


1 Hardware key (dongle) TC 059
2 BV-Scope software none; program is running on the BV Family R1.2 system
3 PMSSec reader Standard security tool
4 Torque wrench none; required for C-arm replacement and/or adjustment
5 Torque wrench small none; 0-20 Nm
6 Torque wrench large none; 20-80 Nm

3.8.2 Phantoms kit

To carry out IQ [image quality] performance checks, a selection of X-ray phantoms is required. Refer to the
Section “Image performance checks”.

3.8.3 Consumables

Consumables ToolCode
- Conductive foam (to store chips) none; general
- Screw container none; general

No other standard tools and/or test equipment are required or need to be ordered for the servicing of the
systems.

3.9 INSTALLATION OF THE SERVICE PC

To enable the service PC to operate together with the BV Family R1.2 Systems, certain software has to be
installed. Refer to SM-SW section 1.

SM-G 2 - 10 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
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Service Manual BV Family R1.2 Section 2
General Introduction

4 SAFETY

4.1 INTRODUCTION

Philips Medical Systems products are designed to meet stringent safety standards. However all medical
electrical equipment requires proper installation, operation and maintenance to ensure the safety of both the
users and the patients.

Therefore, it is vital that you read, note and strictly observe all Danger notices and Safety markings of the
Systems and that you pay particular attention to all safety directions via NOTES, WARNINGS and
CAUTIONS in both the Instructions for Use and the Service Manual.

Before attempting to use the equipment for any corrective maintenance activity, you must read through and
understand the emergency procedures described in this section. Refer to the relevant Section of the
Instructions for Use of the BV Family Systems.

4.2 EMERGENCY PROCEDURES

In case of a general emergency caused by the BV Family R1.2 system, it is recommended to switch OFF the
system:
• By pressing the [System off] key on the Mobile Viewing Station or the [C-Arm Stand off] key on the C-arm
Stand.
Alternatively:
• By removing the mains plug from the socket outlet.

4.3 SAFETY DIRECTIONS

4.3.1 Electrical safety

For your protection, observe the following basic safety requirements.


• Follow all NOTE, WARNING and CAUTION instructions and all labels on the equipment;
• Ensure that the voltage and frequency rating of the power outlet matches the electrical rating labels
on the system;
• Use properly grounded power outlets.

WARNING

Do not remove covers or cables from this equipment, unless expressly instructed to do so in this manual. High
electrical voltages are present within this equipment. Removing covers or cables could lead to serious or fatal
personal injury.
________________

WARNING

Covers or cables should only be removed by qualified and authorized FSEs. In this context, qualified means
those who are legally permitted to work on this type of medical electrical equipment in the jurisdiction(s) where
the equipment is being serviced, and authorized means those who are authorized by the user of the
equipment.
Only service this equipment in rooms or areas that comply with all applicable laws (or regulations having the
force of law) concerning electrical safety for this type of equipment.
________________

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 11


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

WARNING

The battery voltage remains at 367 V DC in the BV Pulsera, even when the mains cable has been
unplugged. Always disconnect the battery cabling before removing the cover of the component box.
________________

The following electrical safety precautions will apply:

Item Problem Precaution


General Electric shock Unplug AC power cord
before working on power
supply
AC power cord Electric shock Unplug AC power cord
before working on power
supply
Grounding Leave AC power cord to
enable grounding to replace
drives, Dims, chips or
system board
Wrist strap ESD Wear wrist strap when
handling drives, PCB, etc.
ESD mat ESD An approved anti-static mat
provides protection from
static damage when used
with wrist strap
PCB ESD Handle a PCB by its edges;
store PCB in anti static bag
Cover System damage & Replace cover after working
overheating on the system
Energy storage unit Measuring with oscilloscope The oscilloscope must not
be in contact with the mains
earth
BV Pulsera only Electric shock High voltage at all times (310
– 367 V); disconnect the
battery cables & mains plug
before coming into contact
with battery

SM-G 2 - 12 (05.0) BV Family R1.2 / Volume 1


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Service Manual BV Family R1.2 Section 2
General Introduction

4.3.2 Transportation safety

When moving mobile or transportable devices, take care to avoid colliding with or overrunning objects and
persons. The service engineer must be familiar with the brake system and all movement controls for driving
before moving the equipment. If relevant, set mobile devices in an indicated transport position, before moving
them.

WARNING

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.
________________

4.3.3 Mechanical safety

WARNING

Covers should only be removed by qualified and authorized service personnel. In this context, qualified means
those who are legally permitted to work on this type of medical equipment in the jurisdiction(s) in which the
equipment is being used, and authorized means those who are authorized by the user of the equipment.
Other service engineers should never remove the covers themselves.
________________

4.3.4 Explosion safety

It is not allowed to service or use this equipment in the presence of explosive gases or vapors. Use of
electrical equipment in an environment for which it was not designed can lead to fire or explosion.

WARNING

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

4.3.5 Fire safety

Service of electrical equipment in an environment for which it was not designed can lead to fire or explosion.
Fire regulations for the type of medical area being serviced must be fully applied, observed and enforced. Fire
extinguishers must be provided for both electrical and non-electrical fires.
All service engineers should be fully aware of local fire procedures.

4.3.6 Electromagnetic compatibility [EMC]

The Systems comply with the requirements of applicable EMC standards. Emissions of electromagnetic
interference (radiated or conducted) do not exceed permitted levels, and the System is resistant to
interference from other equipment within these levels.

4.3.7 Mobile telephones & similar products

The Systems comply with the requirements of applicable EMC standards.


Other electronic equipment exceeding the limits defined in such EMC standards, such as certain mobile
telephones, under unusual circumstances, could affect the operation of the systems.

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 13


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

4.3.8 Radiation safety & guidelines

Only qualified and authorized personnel may service this equipment. In this context, qualified means those
who are legally permitted to service this type of medical electrical equipment in the jurisdiction(s) in which the
equipment is being used, and authorized means those who are authorized by the user of the equipment.
Field service, servicing the equipment and the user, working within the examination room must observe all
laws and regulations, which have the force of law within the jurisdiction(s) concerned. If you are in any doubt
about these laws and regulations, do not service the equipment.

In addition, users are strongly urged to acquaint themselves with the current recommendations of the
International Commission of Radiological Protection, and in the United States, with those of the US National
Council for Radiological Protection.

ICRP, Pergamon Press, Oxford, New York, Beijing, Frankfurt, Sao Paolo, Sydney, Tokyo, Toronto
NCRP, Suite 800, 7910 Woodmont Avenue, Bethesda, Maryland 20814, USA.

Full use must be made of all radiation protection features on the equipment, and of all radiation protection
devices, protective clothing, accessories, systems and procedures available to the service engineer.

WARNING

Never attempt to remove, modify, override or frustrate any safety device on the equipment. Interfering with
safety devices could lead to fatal or other serious personal injury.
________________

Only use prescribed dose rate necessary to perform a particular examination or treatment.

Radiation guidelines
When performing radiation, the following rules should be followed:
− Do not radiate when not necessary
− Radiate for a time as short as possible
− Use automatic dose rate control whenever possible
− Stay away as far as possible from the radiated object
− Wear aprons and other protective clothing as appropriate
− Use badges to monitor the radiation levels received
− Collimate as much as possible
− 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)
− Place the X-ray source under table for extra user safety
− Take into account any adverse effects that may arise due to materials located in the X-ray beam, for
example, the operating table

WARNING

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

SM-G 2 - 14 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

4.3.9 Laser light radiation safety

The laser light in a LAT should be used only under supervision of a medically trained person with knowledge
of the hazards implied by the use of laser light.
It is the user’s responsibility to have fulfilled the local safety regulations regarding laser light radiation.

WARNING

Do not stare into the beam of Class II (FDA) / Class 3A (IEC) laser.
________________

WARNING

The laser must not be switched on without purpose; unnecessary exposure must be avoided.
________________

4.3.10 Safety label positioning

The system has various warning labels, see the Instructions for use for their positions.

Central labeling station (C)


The central labeling station contains the following information about the certifiable items (DHHS):
• X-ray control
• X-ray control (XTV)
• tube housing assembly
• image intensifier
• X-ray generator
• beam limiting device
• laser product
• X-ray tube
And the complete system configuration.

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 15


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Section 2 Service Manual BV Family R1.2
General Introduction

5 AUTHORIZATION

5.1 SOFTWARE LICENSE AGREEMENT

For the proper and flexible functioning of the BV Family R1.2 Systems a dedicated software package has
been developed for professional support. To be able to offer the relevant functionality to the various categories
of users and operators, a software protection mechanism is defined, which matches the possible software
license agreements. To allow for such a software protection, a software license key is installed on the DFI,
based on a 32-character string. Part of the 32-character string is the - system unique - 8-character Host ID
string. It enables an adequate solution for licensed software utilization. The software license key and the host
ID have already been installed in the factory to allow for on-site specific activities, such as customization,
adjustment, calibration and performance testing of the systems.

Each customer has to sign up a software license agreement before the release of the ordered system.
A standard procedure is that the installation of the character string and the host ID string, reflecting the
software license agreement, is part of the configuration of the system in the factory. Applying this procedure
means a programmed and fully tested system before its shipment.

To allow for modifications of the functionality of the system it is possible, after having signed a new software
license agreement, to change the system on site.

NOTE

The re-installation of the license agreement related strings has to be done by the PMS representative on-site.
________________

5.2 PROTECTION POLICY

BV-Scope uses a hardware key (dongle) to protect serviceable functions. As applied within Surgery, it is only
allowed to be used by authorized users.
To be able to offer the relevant functionality to the categories of BV-Scope users, a protection mechanism is
defined which matches the possible protection levels. There are 3 levels of authorization, see table below.

Authorization level required and user types

Authorization level
User types (levels) Password required PMS sec & Dongle
required
BV-Scope Administrator (A) X*
BV-Scope Service (S0, S1, S2) Dongle level 0, 1 or 2
BV-Scope Factory (S3) Dongle level 3
*) This password can be configured with the authorization levels S0 and higher, refer to SM-SW.

In this definition, level S3 means the highest access rights. In practice, this means that these procedures are
allowed to be used by the smallest category of users (e.g. high level specialists). In special occasions, it can
be useful to make use of authorization level S3: contact the helpdesk.

The BV-Scope administrator (level A), has the lowest access rights. The BV-Scope administrator does not
require a hardware key, but has restricted access.

For all user types, only the permitted procedures are visible.

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Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

5.3 HARDWARE-KEY CONSIGNMENT AGREEMENT

Each service engineer, both PMS employed or user employed has to sign up a HW-key consignment
agreement prior to any work to be done above protection level A.
A standard procedure is that the HW key software installation on the Service PC, reflecting the protection /
authorization level, can be done after having signed a consignment agreement.

5.4 BV FAMILY AUTHORISATION TABLE

5.4.1 Administrator level

BV-Scope selection path: Install > Program manual Minimum authorization level

level = A
- Access Control
- BV-Scope Password Configuration
- System Password Configuration
- Configuration
- User Configuration
- Examination Names
- Network Configuration
- DICOM Target Configuration
- Export Targets
- Printer Targets
- Worklist Query Definition
- Worklist Management
- Modality Performed Procedure
- DICOM Queue Management
- Import
- DICOM Targets
- Printer types
- Export
- DICOM Targets

For explanation of the functions above, refer to SM-SW section 2.


To perform the functions, refer to SM-SW section 3.

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 17


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

5.4.2 Service level


BV-Scope selection path Minimum authorization level
- Install
- Access Control
- BV-Scope Password Configuration A
- System Password Configuration A
- Backup-Restore S2
- Program Automatic
- Configuration S3
- Examination S0
- DICOM Target A
- Printer types A
- Program Manual
- System Configuration S2
- User Configuration A
- Network Configuration A
- Energy Storage S2
- X-ray Tank S2
- Examination Names A
- Site Specific S0
- System Settings S0
- Reset System Data S2
- Demo Mode S2
- DICOM Target Configuration
- Export Targets A
- Printer Targets A
- Worklist Query Definition S2
- Worklist Management A
- Modality Performed Procedure A
- DICOM Queue Management A
- Adjustment
- X-ray Tube S2
- II TV S2
- Image Processor S2
- Collimator S2
- Performance Test
- Image Quality S0
- Indicator-Buzzer S0
- Key Test S0
- X-ray Tube Performance S0
- Copy
- Examination S0
- DICOM Targets A
- Faultfind
- Logging
- Logfile Complete System S0
- Energy Storage History S0
- Tank History S0
- System History and Calibration S0
- Service Utilities
- Retrieve Error list
- Retrieve DFI Error List S0
- Retrieve Suco Error List S0

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Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 2
General Introduction

6 LOGISTICS BV FAMILY SYSTEMS

6.1 SYSTEM DOCUMENTATION

6.1.1 Instructions for Use

The BV Family R1.2 has, as stated before, 3 Family members, the BV Endura, the BV Pulsera and the BV
Libra. For each individual system, Instructions for Use have been prepared.

6.1.2 Service Manual

To perform appropriate service for the BV Family Systems only 1 Service Manual will be prepared. The
differences are mentioned particularly in the various Sections of the manual.

The Service Manual consists of general information and several system manuals. The defined system
manuals are:
− Installation
− Software
− Corrective Maintenance (incl. IQ level 1 checks)
− PEI Units
− Options
− Accessories

6.1.3 IQ performance manual

The Image Quality performance manual, which has been developed to optimize the image quality of the X-ray
systems within PMS, contains not only the level 1 measurements, but also the lower level and non-IQ data
measurements. For normal service practice the level 1 measurements are sufficient to service and maintain
the Systems. For this reason these level 1 modules have been incorporated in the appropriate Section.

NOTE

For the service and maintenance of the BV Family R1.2 Systems only, the [level 1] Image Quality
measurement modules are required and have been incorporated for that reason in the System Manual
Corrective Maintenance.
________________

6.1.4 Planned maintenance manual

Preventive maintenance for X-ray systems is very important and should be done to prevent interruptions
and/or discontinuity for professional users.
A service contract could be agreed upon to carry out preventive maintenance. To support preventive
maintenance a PMS Planned Maintenance Manual is available.

NOTE

To control and reduce the possible risk elements that are related to the usage of X-ray devices in health
related environments, it should be recommended to users to develop adequate service and maintenance
programs. PMS, as a professional medical systems supplier, has developed various service and maintenance
programs. The Planned Maintenance manual can be used to support the programs.
________________

BV Family R1.2 / Volume 1 (05.0) SM-G 2 - 19


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 2 Service Manual BV Family R1.2
General Introduction

6.2 SYSTEM SOFTWARE

6.2.1 Application software delivery

Together with the ordering of the hardware configuration, the application software will be provided.
The software is delivered on CD-ROM.

1. For the BV Family R1.2, release 1.x.x application software


2. The BV Family system configuration data containing:

− Configuration files BV Family R1.2 System


− Examination type
− Config. files enabling fixed anode, rotating anode and 6” , 9” and 12” II operation
− Download tool
− Printer types file.
− Per system type, the relevant System settings *

* the BV Family members do have the following features:


BV Libra 2x exam types **
BV Endura 9x exam types **
BV Pulsera 12x exam type **
** depending on commercial options.

SM-G 2 - 20 (05.0) BV Family R1.2 / Volume 1


Copyright © 2005 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 3
Glossary

Section 3 GLOSSARY

Contents

1. ABBREVIATIONS ...................................................................................................................................3

2. DEFINITIONS AND TERMS....................................................................................................................6

BV Family R1.2 / Volume 1 (03.0) SM-G 3 - 1


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 3 Service Manual BV Family R1.2
Glossary

SM-G 3 - 2 (03.0) BV Family R1.2 / Volume 1


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 3
Glossary

1. ABBREVIATIONS

A
APF Anatomically programmed fluoroscopy
AC Alternating current
AVG Average

B
BIST Built-in self test [DFI & SUCO]
BV “Beeld versterker” (see II)
BV-Scope Service control operating environment

C
CAN Control area network
CAS C-arm stand
CE Conformite Europeen
Console User interface [MVS & CAS]

D
DFI Digital fluoroscopy imaging
DICOM Digital imaging communication for medicine
DC Direct current

E
EMC Electro magnetic compatibility
ESD Electro static discharge

F
FA Fixed anode
FRU Field replaceable unit
FSE Field service engineer
FCO Field change order

H
HDF High definition fluoroscopy
HF High frequency
HT High tension

BV Family R1.2 / Volume 1 (03.0) SM-G 3 - 3


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 3 Service Manual BV Family R1.2
Glossary

I
II Image intensifier
ID Identification
IfU Instructions for use
I/O Input / output
IQ Image quality

L
LAT Laser alignment tool
LDF Low dose fluoroscopy
LAN Local Area Network
LUT Look-up table
LIH Last image hold

M
MVS Mobile viewing station
MCU [Universal] Mains Control Unit

P
PMS Philips Medical Systems Nederland BV
PC Personal computor
POST Power on self test
PEI Product End Item
PCB Printed circuit board

R
RA Rotating anode

S
SUCO Surgery coordinator
SSR Sales Service Region
SRS System Requirements Specification
SSD Sales Service District

T
TCP / IP Transmission control- / Internet protocol

V
VCR Video cassette recorder
VCDR Video compact disc recorder

SM-G 3 - 4 (03.0) BV Family R1.2 / Volume 1


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Service Manual BV Family R1.2 Section 3
Glossary

X
XTV X-ray television
XRD X-ray department

System Manuals

SM-G System Manual General Information


SM-I System Manual Installation
SM-SW System Manual Software
SM-CM System Manual Corrective Maintenance
SM-PEI System Manual PEI units

BV Family R1.2 / Volume 1 (03.0) SM-G 3 - 5


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
Section 3 Service Manual BV Family R1.2
Glossary

2. DEFINITIONS AND TERMS

Owner: Formal user [managerial]

User: Operational user [clinical]

Engineer: User qualified service engineer

LAN: Local area network; to be connected to DICOM Workflow Interface

Host ID: 8 bits string to allow selected authorized use of BV Family R1.2 Systems

Customizing: Changing factory installed [system] default settings

Commissioning: The on-site process of unpacking, re-assembly, setting to work, [IQ] performance testing
and customizing

Standard service Kit: Standard “Tools & Test equipment”

Service PC: Laptop, suitable for service on BV Family R1.2 Systems

Special tools: Special tools required in addition to service kit

Phantom kit: [Standard] phantoms enabling on site IQ [level 1] and/or lower level performance testing and
adjustment & verification

Service parts: Replaceable items

SM-G 3 - 6 (03.0) BV Family R1.2 / Volume 1


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED
SYSTEM MANUAL Snij-lijn
GENERAL INFORMATION
BV FAMILY - RELEASE 1.2

SYSTEM MANUAL GENERAL INFORMATION– BV FAMILY RELEASE 1.2


SYSTEM MANUALS (VOLUME 1 OF 2)

FILING INSTRUCTIONS

This manual should be filed in:


SYSTEM MANUALS BV Family - RELEASE 1.2
VOLUME 1 OF 2

BV Family R1.2 / Volume 1 (03.1) SM – G 0.5


Copyright © 2003 Koninklijke Philips Electronics N.V.
ALL RIGHTS RESERVED

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