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System Manual BV Family R1.2 General Introduction
System Manual BV Family R1.2 General Introduction
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GENERAL
INTRODUCTION
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General IInformation
General nformation
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PMSN Best
Contents
VOLUME 1
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
VOLUME 2
[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
Contents
1 INTRODUCTION .....................................................................................................................................3
1.1 Intended Use of this manual ....................................................................................................................3
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
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
1 INTRODUCTION
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.
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.
________________
3 SERVICE INFORMATION
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.
________________
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.
The service documentation comprises several manuals and documents, which are required for the proper
servicing during the life cycle of the system.
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.
For changes:
• in delivery, a dedicated kit document;
For delta’s:
• both for corrections and for security aspects, a Field Change Order (FCO);
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
To support the activities, PMS operates an intranet website for extensive information regarding medical
systems.
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:
E-mail address:helpdesk.xray.best@philips.com
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.
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.
D-Sub 1 D-Sub 2
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.
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-)
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
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.
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.
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.
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.
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.
________________
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.
________________
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.
________________
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.
________________
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.
________________
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.
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.
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.
________________
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.
________________
The system has various warning labels, see the Instructions for use for their positions.
5 AUTHORIZATION
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.
________________
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
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.
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.
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
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.
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
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.
________________
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.
________________
Together with the ordering of the hardware configuration, the application software will be provided.
The software is delivered on CD-ROM.
Section 3 GLOSSARY
Contents
1. ABBREVIATIONS ...................................................................................................................................3
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
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
X
XTV X-ray television
XRD X-ray department
System Manuals
Host ID: 8 bits string to allow selected authorized use of BV Family R1.2 Systems
Commissioning: The on-site process of unpacking, re-assembly, setting to work, [IQ] performance testing
and customizing
Phantom kit: [Standard] phantoms enabling on site IQ [level 1] and/or lower level performance testing and
adjustment & verification
FILING INSTRUCTIONS