Unfors RaySafe 8603022 User Manual
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DoseAware Dose Manager
Package
INSTRUCTIONS FOR USE
Document version 1.2
English
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Published by Philips Medical Systems Nederland B.V.
Philips Medical Systems Nederland B.V. reserves the right to
make changes to both this document and to the product it
describes. Product specifications are subject to change without
notice. Nothing contained within this document is intended as
any offer, warranty, promise or contractual condition, and must
not be taken as such.
© Koninklijke Philips Electronics N.V. 2009
All Rights are reserved. Reproduction in whole or in part in any
form or by any means, electrical, mechanical or otherwise is
prohibited without the written consent of the copyright holder.
Issue Number 9897 100 01273
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
The Netherlands
Unauthorized copying of this publication may not only infringe
copyright but also reduce the ability of Philips Medical Systems
to provide accurate and up-to-date information to users.
Non-Philips product names may be trademarks of their
respective owners.
Published in The Netherlands.
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DoseAware Dose Manager Package Document version 1.2
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DoseAware Dose Manager Package Document version 1.2
Contents
Introduction..............................................................................................1 1-1
1.1 About the DoseAware System.................................................... 1-1
1.2 About these Instructions for Use................................................ 1-2
1.3 Intended use of the DoseAware System...................................... 1-3
1.4 Compatibility............................................................................ 1-4
1.5 Compliance............................................................................... 1-5
1.6 Training.................................................................................... 1-5
1.7 System requirements.................................................................. 1-5
1.8 Other user manuals.................................................................... 1-5
Safety.........................................................................................................2 2-1
2.1 Important safety directions........................................................ 2-1
2.2 Electrical safety.......................................................................... 2-2
2.3 Mechanical safety....................................................................... 2-3
2.4 Explosion safety......................................................................... 2-3
2.5 Fire safety.................................................................................. 2-3
2.6 Electrostatic discharge (ESD)..................................................... 2-4
2.7 Electromagnetic Compatibility (EMC)...................................... 2-5
2.7.1 Mobile phones and similar RF equipment ................ 2-6
2.8 Modality specific safety.............................................................. 2-7
2.9 Network safety, security, and privacy......................................... 2-8
2.10 Toxic or hazardous substances and elements.............................. 2-9
2.11 Equipment label overview.......................................................... 2-10
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Contents
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Contents
Get to know Dose Manager .................................................................3 3-1
3.1 Introduction to Dose Manager.................................................. 3-1
3.2 Application menu overview........................................................ 3-3
3.3 Home toolbar overview.............................................................. 3-4
3.3.1 PDMs.......................................................................... 3-4
3.3.2 Reports........................................................................ 3-10
3.3.3 Base Stations................................................................ 3-10
3.4 Dose Navigation toolbar overview ........................... 3-11
3.5 Reports Preview toolbar overview ............................ 3-13
3.6 All PDMs window overview ..................................................... 3-15
3.7 Details tab overview................................................................... 3-16
3.7.1 PDM details................................................................. 3-17
3.7.2 Group details............................................................... 3-17
3.7.3 Report details............................................................... 3-18
3.8 Dose graph tab overview............................................................ 3-19
3.8.1 Graph legend............................................................... 3-20
3.8.2 Selections in a dose graph............................................. 3-21
3.8.3 Events in a dose graph.................................................. 3-22
3.9 Dose table tab overview............................................................. 3-22
Use Dose Manager...................................................................................4 4-1
4.1 Get started with Dose Manager................................................. 4-1
4.1.1 Change PDM information and settings....................... 4-1
4.1.2 Collect data from PDM............................................... 4-4
4.1.3 Collect data from Base Station..................................... 4-5
4.1.4 Collect data from USB................................................. 4-6
4.1.5 Show and manage groups of PDMs............................. 4-7
4.1.6 Work with dose sessions............................................... 4-7
4.1.7 Reset dose history......................................................... 4-8
4.1.8 Save data...................................................................... 4-8
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Contents
4.2 Work with the main window..................................................... 4-9
4.2.1 Customize the columns................................................ 4-9
4.2.2 Sort information in the columns.................................. 4-10
4.3 Analyze dose history from one PDM......................................... 4-11
4.3.1 View dose history as a graph ............................. 4-11
4.3.2 Navigate in a graph...................................................... 4-12
4.3.3 Make a selection in a graph.......................................... 4-13
4.3.4 View dose history as a table.......................................... 4-14
4.3.5 Print data from a dose graph or dose table ........ 4-15
4.3.6 Export data from a dose table ............ 4-16
4.4 Analyze dose data from several PDMs........................................ 4-18
4.4.1 View dose history as a graph......................................... 4-18
4.4.2 View dose history as a table.......................................... 4-21
4.4.3 Print data from a dose graph or dose table
.................................................................................... 4-22
4.4.4 Export data from a dose table ...................................... 4-22
4.5 Reports...................................................................................... 4-22
4.5.1 Create reports.............................................................. 4-23
4.5.2 Export or e-mail a report.............................................. 4-24
4.6 Dose Manager options............................................................... 4-26
4.6.1 Set password................................................................ 4-26
4.6.2 Change password......................................................... 4-26
4.6.3 Change language.......................................................... 4-26
4.7 Dose manager license................................................................. 4-27
Product disposal.......................................................................................5 5-1
5.1 Introduction.............................................................................. 5-1
5.2 Passing the system on to another user........................................ 5-1
5.3 Final disposal of the system........................................................ 5-2
5.4 Fitting, removing, and disposing of batteries.............................. 5-3
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Contents
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Contents
Technical data..........................................................................................6 6-1
6.1 PDM and Base Station/Dose Manager memories...................... 6-1
6.2 Time management..................................................................... 6-1
6.3 Security and privacy requirements.............................................. 6-2
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DoseAware Dose Manager Package Document version 1.2
1
1.1
Introduction
About the DoseAware System
Figure 1.1 DoseAware System overview with Dose Manager Package components highlighted
Legend
1 Base Station 2 PDM rack
3 Ethernet 4 Radio
5 Dose Manager 6 Dose View
7 PDM 8 USB
9 Cradle
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1.2 About these Instructions for Use
1-2
1.2
Introduction
About these Instructions for Use
W A R N I N G
C A U T I O N
N O T E
The Dose Manager Package consists of:
Dose Manager licensed software (CD)
•
• User Manual (CD)
• Cradle, USB cable
These Instructions for Use are intended to assist users in the safe and
effective operation of the product described.
Before attempting to operate the product, you must read these Instructions
for Use, noting and strictly observing all WARNINGS and CAUTION
notices.
Pay special attention to all the information given and procedures described
in the Safety section.
A WARNING alerts you to a potential serious outcome, adverse event or safety
hazard. Failure to observe a warning may result in death or serious injury to the
operator or patient.
A CAUTION alerts you to where special care is necessary for the safe and effective
use of the product. Failure to observe a caution may result in minor or moderate
personal injury or damage to the product or other property, and possibly in a remote
risk of more serious injury, and/or cause environmental pollution.
NOTES highlight unusual points as an aid to the operator.
These Instructions for Use describe the most extensive configuration of the
product, with the maximum number of options and accessories. Not every
function described may be available on your product.
These Instructions for Use describes the Base Station Package. In order to
get an immediate hands-on experience of the Base Station
Package, we recommended that you interact with the Base Station,
DoseView, and Cradle in parallel to reading these Instructions for Use.
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DoseAware Dose Manager Package Document version 1.2
1.3
Intended use of the DoseAware System
N O T E S
Intended use of the DoseAware System 1.3
These Instructions for Use describe the Dose Manager software and its
functions. In order to get an immediate hands-on experience of Dose
Manager, we recommended that you interact with Dose Manager in parallel
to reading these Instructions for Use.
This Philips product is intended to be installed, used and operated only in
accordance with the safety procedures and operating instructions given in
these Instructions for Use for the purpose for which it was designed. The
purpose for which the product is intended is given below. However, nothing
stated in these Instructions for Use reduces users’ responsibilities for sound
clinical judgment and best clinical procedure.
The DoseAware System is an electronic X-ray dose monitoring system. The
intended use is to improve the awareness of people, who work with or are in
the presence of X-Ray imaging equipment, about their occupational dose
(also known as staff dose). The awareness focuses on:
A graphical visualization of the real-time staff dose rate while working
•
with X-Ray equipment in examination rooms during medical procedures;
• Instant access to historical staff dose for reporting and analysis purposes.
The benefits of the DoseAware System are to:
• Make people aware of their received staff dose during clinical work with
X-ray imaging equipment;
• Instantly visualize the result of reducing measures of occupational
dose by, for example, changing a person’s position in the examination room.
The DoseAware System may not be used as a legal staff dose recording
solution. The DoseAware System is not intended for patient use.
• Do not expose the PDMs in direct X-ray beam. They are designed to be exposed to
scattered radiation only.
• The Dose Manager, DoseView, Cradle and PDM Rack are not intended to be used
inside examination rooms.
• The DoseAware product is not a replacement for a TLD (ThermoLuminescent
Dosimeter) or similar product.
Introduction
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1.4 Compatibility
1-4
1.4
Introduction
Compatibility
W A R N I N G
Installation, use and operation of this product is subject to the law in the
jurisdiction(s) in which the product is being used. Operators must only
install, use and operate the DoseAware System in such ways as do not
conflict with applicable laws, or regulations, which have the force of law.
Uses of the Allura CV20 for purposes other than those intended and Uses of
the DoseAware System for purposes other than those intended and expressly
stated by the manufacturer, as well as incorrect use or operation, may relieve
the manufacturer (or his agent) from all or some responsibility for resultant
non-compliance, damage or injury.
The product described in this manual should not be used in combination
with other products or components unless such other products or
components are expressly recognized as compatible by Philips Healthcare.
(A list of such products and components is available from the manufacturer.)
Changes and/or additions to the product should only be carried out by
Philips Medical Systems or by third parties expressly authorized by Philips
Medical Systems to do so. Such changes and/or additions must comply with
all applicable laws and regulations that have the force of law within the
jurisdiction(s) concerned, and with best engineering practice.
Changes and/or additions to the product that are carried out by persons without the
appropriate training and/or using unapproved spare parts may lead to the Philips
Medical Systems warranty being voided. As with all complex technical products,
maintenance by persons not appropriately qualified and/or using unapproved spare
parts carries serious risks of damage to the product and of personal injury.
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DoseAware Dose Manager Package Document version 1.2
1.5
1.6
1.7
1.8
Compliance
Training
System requirements
Other user manuals
Compliance 1.5
The Philips DoseAware System complies with relevant international and
national standards and laws. Information on compliance will be supplied on
request by your local Philips Medical Systems representative, or by the
manufacturer.
Users of this product must have received adequate training on its safe and
effective use before attempting to operate the product described in these
Instructions for Use. Training requirements for this type of device will vary
from country to country. Users must make sure they receive adequate
training in accordance with local laws or regulations.
If you require further information about training in the use of this product,
please contact your local Philips Medical Systems representative.
Alternatively, contact the manufacturer.
•
Operating systems: Windows Vista or Windows XP.
• .NET 3.5.
• At least one USB port available.
• At least 2 GB of system memory available.
• At least 40 GB hard drive with at least 15 GB of memory available.
• Recommended screen resolution at least 1280 x 1024.
• The Base Station and DoseView are described in a
separate user manual, which can be found on the CD delivered in the box
together with the Base Station package.
• The PDMs are briefly described in the PDM Quick Guide, a leaflet that
is delivered in the box together with the PDM.
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1.8 Other user manuals
1-6
Introduction
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2.1
Safety
Important safety directions
W A R N I N G
W A R N I N G
If the DoseAware system is not functioning correct or damage is visible,
inform a Philips service engineer, which will take appropriate actions in
order not to harm personnel or patients.
Handle the hardware and software with care. Make sure that the hardware
and software is used and stored in a secured environment to prevent
unauthorized access.
Maintenance & faults
Do not use the product for any application until you are sure that the user routine-
checks have been satisfactorily completed, and that the periodic maintenance of the
product is up to date. If any part of the product is known (or suspected) to be
defective or wrongly adjusted, DO NOT USE the product until a repair has been
made. Operation of the product with defective or wrongly adjusted components could
expose the user or the patient to radiation or other safety hazards. This could lead to
fatal or other serious personal injury, or to clinical misdiagnosis/clinical mistreatment.
Safety awareness
Do not use the product for any application until you have read, understood and know
all the safety information, safety procedures and emergency procedures contained in
this Safety section. Operation of the product without a proper awareness of how to
use it safely could lead to fatal or other serious personal injury. It could also lead to
clinical misdiagnosis/clinical mistreatment.
Safety
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2.2 Electrical safety
W A R N I N G S
W A R N I N G
W A R N I N G
2.2
Electrical safety
W A R N I N G
2-2
Safety
Adequate training
• Do not use the product for any application until you have received adequate and
proper training in its safe and effective operation. If you are unsure of your ability
to operate this product safely and effectively, DO NOT USE IT. Operation of this
product without proper and adequate training could lead to fatal or other serious
personal injury. It could also lead to clinical misdiagnosis/clinical mistreatment.
• Do not operate the product with patients unless you have an adequate
understanding of its capabilities and functions. Using this product without such an
understanding may compromise its effectiveness and/or reduce the safety of the
patient, you and others.
Safety devices
Never attempt to remove, modify, override or frustrate any safety device on the
product. Interfering with safety devices could lead to fatal or other serious personal
injury.
Intended use and compatibility
Do not use the product for any purpose other than those for which it is intended. Do
not use the product with products other than that which Philips Medical Systems
recognizes as compatible. Operation of the product for unintended purposes, or with
incompatible products, could lead to fatal or other serious injury. It could also lead to
clinical misdiagnosis/clinical mistreatment.
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Do not remove covers or cables from this product. Dangerous electrical voltages are
present within this product. Removing covers or cables could lead to serious or fatal
personal injury.
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2.3
2.4
W A R N I N G S
2.5
Mechanical safety
W A R N I N G
Explosion safety
Fire safety
Mechanical safety 2.3
Covers or cables should only be removed by qualified and authorized service
personnel. Use this product in rooms or areas that comply with all
applicable laws (or regulations having the force of law) concerning electrical
safety for this type of product.
Electrically isolate this product from the mains electrical supply before
cleaning, disinfecting or sterilizing it.
Do not remove covers from this product. Removing covers could lead to serious or
fatal personal injury.
Covers 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 product in the jurisdiction(s) in which the
product is being used, and authorized means those authorized by the user of
the product.
• Do not use this product in the presence of explosive gases or vapors, such as
certain anesthetic gases.
• Do not use flammable or potentially explosive disinfecting sprays.
• Use of this product in an environment for which it was not designed can lead to
fire or explosion.
Use of electrical product in an environment for which it was not
designed can lead to fire or explosion.
Safety
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2.6 Electrostatic discharge (ESD)
2-4
2.6
W A R N I N G
Electrostatic discharge (ESD)
C A U T I O N S
Safety
Fire regulations for the type of medical area being used should be fully
applied, observed and enforced. Fire extinguishers should be available for
both electrical and non-electrical fires.
Only use extinguishers on electrical or chemical fires, which are specifically labeled
for those purposes. 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 product from electrical and other
supplies before attempting to fight a fire. This will reduce the risk of electric
shocks.
• Always wait at least ten seconds after the product is switched OFF before switching
the product back to ON.
• Always use proper static procedures, protection, and product prior to opening and
during handling of this product. This product contains components that are
electrostatic sensitive. Failure to use ESD procedures may cause damage to these
components. Such damage to components is not covered by Philips warranties.
Connections to sensitive parts are identified by the ESD warning symbol as
shown.
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ESD can amount to a significant voltage, which may cause damage to PCBs
or other system components.
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2.7
Electromagnetic Compatibility (EMC)
Electromagnetic Compatibility (EMC) 2.7
ESD damage is cumulative and may not be apparent at first, as indicated by
a hard failure, but can cause degraded performance. Therefore, always use
proper ESD handling procedures. ESD can result from low humidity
conditions, use of electrical equipment on carpeting, linens, and clothing.
This Philips product complies with relevant international and national laws
and standards on EMC (electromagnetic compatibility) for this type of
product when used as intended. Such laws and standards define both the
permissible electromagnetic emission levels from equipment and its required
immunity to electromagnetic interference from external sources.
Other electronic products exceeding the limits defined in such EMC
standards could, under unusual circumstances, affect the operation of the
product.
Medical electrical products need special precautions regarding EMC, and
•
need to be installed and put into service according to EMC information
provided in the accompanying documents.
• The use of accessories and cables other than those specified may result in
increased emission or decreased immunity levels.
• The product should not be used adjacent to or stacked with other
products and that if adjacent or stacked use is necessary, it should be
observed to verify normal operation.
This equipment is intended for use in a hospital environment. Operation in
other than hospital environments may compromise electromagnetic
compatibility.
The Base Station and PDM comply with part 15 of the FCC Rules.
Operation is subject to the following conditions :(1) This device may not
cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Changes or modifications to the equipment not expressly approved by the
party responsible for compliance could void the user’s authority to operate
the equipment.
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2.7 Electromagnetic Compatibility (EMC)
This device complies with Industry Canada license-exempt RSS standard(s).
Operation is subject to the following two conditions: (1) This device may
not cause interference, and (2) this device must accept any interference,
including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux
appareils radio exempts de licence. L'exploitation est autorisée aux deux
conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2)
l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même
si le brouillage est susceptible d'en compromettre le fonctionnement.
This class A digital apparatus complies with Canadian ICES-003.
Cet appareil numérique de la classe A est conforme à la norme NMB-003 du
Canada.
The Base Station and PDM have been tested and found to comply with the
limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful
interference when the equipment is operated in a commercial environment.
This equipment generates, uses, and can radiate radio frequency energy and,
if not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in
which case the user will be required to correct the interference at his own
expense.
The DoseAware system is intended for use in the electromagnetic
environment in which radiated RF disturbances are controlled.
Portable and mobile RF communications can affect medical electrical equipment. Use
caution when using such communication devices within the specified range of medical
electrical devices.
2-6
2.7.1
Mobile phones and similar RF equipment
C A U T I O N
Safety
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2.8
W A R N I N G
N O T E
Modality specific safety
Modality specific safety 2.8
The customer or the user of the DoseAware system can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
DoseAware system as recommended below, according to the maximum
output power of the communications equipment:
A minimum distance of 20 cm between a PDM and a mobile phone or
•
regular electronic device (e.g. a computer).
• A minimum distance of 50 cm between a PDM and a medical device or
intended radiator (e.g. a wireless router).
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
During communication between the Base Station and PDMs, personal data is
transmitted in open air.
Be careful when using a PDM while being near a patient and make sure that
the PDM does not fall or comes in contact with other equipment (such as a
catheter) to endanger the procedure.
Do not move a PDM to an unknown environment (for example another
hospital). If you are visiting unknown environments, there is a risk that
personal data is registered there. For correct registration of staff dose data,
only use the PDM within designated environment.
Philips Medical Systems declares that all CE marked DoseAware products
incorporating Radio and Telecoms Terminal Equipment functionality are in
compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC.
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2.9 Network safety, security, and privacy
2-8
2.9
Safety
Network safety, security, and privacy
Customer Role in the Product Security Partnership
We recognize that the security of Philips Medical Systems products is an
important part of your facility's security-in depth strategy. However, these
benefits can only be realized if you implement a comprehensive, multilayered strategy (including policies, processes, and technologies) to protect
information and systems from external and internal threats.
Following industry-standard practice, your strategy should address physical
security, operational security, procedural security, risk management, security
policies, and contingency planning. The practical implementation of
technical security elements varies by site and may employ a number of
technologies, including firewalls, virus-scanning software, authentication
technologies, etc.
As with any computer-based system, protection must be provided such that
firewalls and/or other security devices are in place between the medical
system and any externally accessible systems.
The USA Veterans Administration has developed a widely used Medical
Device Isolation Architecture for this purpose. Such perimeter and network
defenses are essential elements in a comprehensive medical device security
strategy.
For our product security policy statement and additional information, see
the Philips Medical Systems product security website at:
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Toxic or hazardous substances and elements 2.10
http://www.healthcare.philips.com/main/support/productsecurity
2.10
Toxic or hazardous substances and elements
Toxic or hazardous substances and elements
DoseAware
component
Lead (Pb) Mercury (Hg) Cadmium (Cd) Hexavalent
The following table details the toxic or hazardous substances and elements
which are present in the DoseAware systems.
Chromium (Cr6+)
Polybrominated
Biphenyls (PBB)
Base Station O O O O O O
PDM O O O O O O
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is
below the limit requirement in SJ/T11363–2006.
Perchlorate materials
In this product, perchlorate material is present in lithium coin cells and/or
batteries. Special handling may apply for these materials, for more
information, go to:
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www.dtsc.ca.gov/hazardouswaste/perchlorate
REACH Declaration
REACH requires Philips Healthcare (PH) to provide chemical content
information for Substances of Very High Concern (SVHC) if they are
present above 0.1% of the product weight. Components within electric and
electronic equipment may contain phthalates above the threshold (e.g. bis(2ethyl(hexyl)phthalate), CAS nr.: 117-81-7). The SVHC list is updated on a
regular basis. Therefore, refer to the following Philips REACH website for
the most up-to-date list of products containing SVHC above the threshold:
http://www.philips.com/about/sustainability/reach.page
China RoHS Hazardous Substances Declaration
For information, please see the Philips Medical Systems product
sustainability website at:
DoseAware Dose Manager Package Document version 1.2
Polybrominated
Diphenyl Ethers
(PBDE)
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2.11 Equipment label overview
2-10
2.11
Safety
Equipment label overview
N O T E
http://www.healthcare.philips.com/main/about/Sustainability
This section describes the DoseAware product labels and their locations.
Some of the information (such as frequency, type, date of manufacture, and other
markings) on the labels for your DoseAware product may vary from the examples
shown below.
Base Station product label
The following Base Station product label is located on the rear side of the
Base Station.
Figure 2.1 Base Station label
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Equipment label overview 2.11
Base station product label for products sold in the EU
The following Base Station product label is located on the rear side of the
Base Station for products sold in European Union (EU) countries.
Figure 2.2 Base Station label for products sold in the EU
Cradle product label
The Cradle product label is located on the bottom of the Cradle.
Figure 2.3 Cradle label
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2.11 Equipment label overview
2-12
Safety
PDM product label
The following PDM product label is located on the rear side of the PDM.
Figure 2.4 PDM label
PDM product label for products sold in the EU
The following PDM product label is located on the rear side of the PDM
for products sold in European Union (EU) countries.
Figure 2.5 PDM label for products sold in the EU
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3.1
Get to know Dose Manager
W A R N I N G
Introduction to Dose Manager
This chapter describes the available features in Dose Manager. Instructions
and commonly used workflows are found in section “Use Dose Manager”
on page 4-1 .
Do not start up the product unless you and all other users present have read, fully
understood and know all the safety information and emergency procedures given in
the Safety section of these Instructions for Use. Operation of the product without
having read, understood and knowing all the safety information and procedures in the
Safety section could lead to fatal or other serious personal injury, clinical
misdiagnosis, or clinical mistreatment.
Dose Manager is a powerful, easy-to-use tool for analyzing, reporting and
storing dose information as well as administrating multiple PDMs.
Dose Manager makes it possible for you to:
Store and manage dose history for multiple PDMs.
•
• Collect dose history from Base Stations in your local network.
• Analyze dose data.
• View dose history as a graph or table.
• Export dose data for further analysis with other software tools, such as Excel.
• Create and print reports of dose history.
Get to know Dose Manager
3-1
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