General view7
Possible movements7
Control desk8
Collimator8
Messages on the display9
Operation
Transport10
Positioning the unit11
Switching on the unit12
In the event of an error message12
Preparing the tube assembly13
Overview of operation14
Program overview15
Programmed exposure16
Manual exposure17
Radiography18
Terminating operation19
Parking the unit (in the parking position)19
Remote control20
Programming
Saving APR parameters21
Maintenance
Tests by the user22
Safety checks according to the
Medical Device Directive22
Repairs23
Recording results23
Main fuse23
Cleaning24
Disinfection24
Technical data25
Appendix
Exposure table29
Safety
This manual is designed to make it possible for you to
work with the X-ray equipment described safely. You
may operate the X-ray equipment only in compliance
with the safety instructions in this manual and not use it
for purposes other than for which it is intended. The
X-ray equipment may only be operated by persons who
have the necessary expertise in radiation protection or
knowledge of radiation protection and who have been
instructed in how to operate the X-ray equipment.
In the United States, Federal law restricts this
device to sale, distribution, and use by or on the
order of a physician.
It is always the user who is responsible for compliance
with the regulations applying to installation and operation of X-ray equipment.
• You must never use the X-ray equipment if it
has any electrical, mechanical or radiological
defects. This particularly applies to faulty
indicators, displays, warnings and alarms.
• If the user wishes to connect the X-ray
equipment to other equipment, components
or assemblies and if it is not apparent from
the technical data whether it can be safely
combined with such equipment, components or assemblies, the user must ensure
that the safety of the patient, operating staff
and the environment is not affected by the
planned combination by consulting the
manufacturers involved or by making enquiries from an expert.
• Philips is responsible for the safety features
of its products only if maintenance, repairs
and modifications have been performed by
Philips or by persons explicitly authorised to
do so by Philips.
• As with any technical appliance, this equipment requires not only correct operation but
also regular, competent maintenance and
care, which are described in the section
“Maintenance“.
• If you operate the X-ray equipment incorrectly or if the user fails to have maintenance
carried out properly, Philips cannot be held
liable for any malfunctions, damage or
injuries.
• Safety circuits must be neither removed nor
modified.
• You may remove or open parts of the
housing only if you are instructed to do so in
this manual.
Electrical safety
This X-ray equipment meets the safety class I and
type B according to IEC 60601-1.
Only trained maintenance staff may remove the covers
from the high-voltage cable of the X-ray tube assembly
and the high-voltage generator.
This X-ray equipment may only be operated in medical
rooms which meet IEC requirements.
• You must never operate this X-ray equipment in areas where there is a risk of
explosion.
• Detergents and disinfectants, including
those used on patients, may create explosive mixtures of gases. Please observe the
relevant regulations.
Mechanical safety
• Never hold the tube carrier arm to position
the tube assembly. There is a risk you may
trap your fingers! Use the grip on the tube
assembly.
• Only transport the X-ray unit when the tube
assembly arm has been locked in the transit
position.
4
Radiation protection
Ensure that before each X-ray exposure all the
necessary radiation protection measures have
been taken.
When using X-radiation the personnel in the examination room must comply with the valid radiation protection regulations. In this respect please observe the
following rules:
• To protect the patient against radiation always use
radiation protection accessories in addition to devices
which are fitted to the X-ray equipment (e.g. diaphragm, spacer, filter).
•Wear protective clothing. Radiation protection aprons
with a lead equivalent of 0.35 mm attenuate X-radiation at 50 kV by 99.84%, and at 100 kV by 91.2%.
• Distance is the most effective radiation protection.
Keep as large a distance as possible away from the
object exposed and the X-ray tube assembly. Use the
full length of the release switch cable.
• Avoid working in the direct beam of radiation.
• Always use the smallest X-ray field collimation.
Scattered radiation is largely dependent on the
volume of the object being exposed.
• Always select a focal spot to skin distance as long as
possible to keep the absorbed dose for the patient as
low as could reasonably be possible.
• Always be aware that any material brought into the
path of radiation between the patient and the image
receptor (e.g. film) will have a negative influence on
the image quality as well as on the patient dose.
Philips
– supports you in disposing of the X-ray equipment
described in a proper manner
– returns reusable parts to the production cycle via
certified disposal companies and
– thus helps to reduce environmental pollution.
Consequently, do contact your Philips Service Organisation in full confidence.
Conformity
0123
This Medical Device meets the provisions of the
Medical Device Directive MDD 93/42 EEC (93).
If you have further questions regarding the applicable
national or international standards, please address them
to:
Philips Medical Systems DMC GmbH
Quality Assurance Department
Roentgenstrasse 24
D-22335 Hamburg
Fax: (+49) 40/50 78-21 47
Safety circuits which may prevent X-radiation from
being switched on under certain conditions may be
neither removed nor modified.
Disposal
Philips manufactures state-of-the-art X-ray equipment in
terms of safety and environmental protection. Assuming no parts of the system housing are opened and
assuming the system is used properly there are no risks
to persons or the environment.
To comply with regulations it is necessary to use
materials which may be harmful to the environment and
therefore have to be disposed of in a proper manner.
For this reason you must not dispose of the X-ray
equipment together with industrial or domestic
waste.
When receiving data media the user acquires a nonexclusive, non-transferable right to use the software
stored on them in connection with the hardware components delivered with it by Philips.
Changes to software, the use of which on hardware
components other than those delivered by Philips in
this connection (multiple use) or the making of copies,
even for purposes of data backup, must be approved by
Philips in writing beforehand.
5
Safety
Electromagnetic compatibility (EMC)
In accordance with its intended use, this electronic
apparatus complies with the law governing EMC, which
defines the permitted emission levels from electronic
equipment and its required immunity against electromagnetic fields.
Nevertheless, it is not possible to exclude with absolute
certainty the possibility that radio signals from
high-frequency transmitters, e.g. mobile phones or
similar mobile radio equipment, which themselves
conform to the EMC regulations, may influence the
proper functioning of electromedical apparatus if such
equipment is operated in close proximity and with
relatively high transmitting power. Therefore, operation
of such radio equipment in the immediate vicinity of
electronically controlled medical apparatus should be
avoided to eliminate any risk of interference.
Explanation:
Electronic apparatus that satisfies the EMC requirements is designed so that under normal conditions
there is no risk of malfunction caused by electromagnetic interference. However, in the case of radio signals
from high-frequency transmitters with a relatively high
transmitting power, the risk of electromagnetic incompatibility when operated in close proximity to electronic
apparatus cannot be totally ruled out.
In unusual circumstances unintended functions of the
apparatus could be initiated, possibly giving rise to
undesirable risks for the patient or user.
For this reason, all kinds of transmission with mobile
radio equipment should be avoided. This also applies
when the apparatus is in „standby“ mode.
Mobile telephones must be switched off in designated
problem zones.
6
Legend
General view
1 Tube assembly
2 Angle scales for position of tube
assembly
3 Grip for positioning tube
assembly
4 Collimator with light field
indicator
5 Fixing grip for tube assembly
swivel
6 Tube carrier arm
7 Transportation securing device
8 Handswitch for radiography