Philips DoseAware Base Station Instructions For Use Manual

DoseAware Base Station
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 9896 002 16623

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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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.................................................................. 1-6

1.8 Other user manuals.................................................................... 1-6

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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Using the Base Station............................................................................3 3-1

3.1 Introduction.............................................................................. 3-1

3.2 Getting started........................................................................... 3-2

3.2.1 Starting the wall mounted Base Station........................ 3-2

3.2.2 Starting the MCS mounted Base Station...................... 3-3

3.3 Base Station features.................................................................. 3-3

3.3.1 Online view – view current dose rates

.................................................................................... 3-4

3.3.2 Walk-Up view – view detailed dose data .......... 3-7

3.3.3 Base Station Settings view............................................ 3-11

3.4 Shutting down the Base Station................................................. 3-16

3.4.1 Shutting down a wall mounted Base Station................ 3-16

3.4.2 Shutting down an MCS mounted Base Station............ 3-16

Using DoseView.......................................................................................4 4-1

4.1 Introduction to DoseView......................................................... 4-1

4.2 Getting started with DoseView.................................................. 4-2

4.3 Home Toolbar overview............................................................ 4-3

4.4 PDM panel................................................................................ 4-5

4.4.1 PDM information........................................................ 4-5

4.4.2 Dose information......................................................... 4-6

4.4.3 Selection summary....................................................... 4-6

4.4.4 Change PDM options.................................................. 4-7

4.5 View dose graph........................................................................ 4-12

4.6 View dose table.......................................................................... 4-14

4.7 Specify password and language................................................... 4-15

Using the PDM.........................................................................................5 5-1

5.1 Introduction.............................................................................. 5-1

5.2 Getting started........................................................................... 5-1

Contents

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Using the Cradle......................................................................................6 6-1

6.1 Introduction.............................................................................. 6-1

6.2 Getting started........................................................................... 6-2

Maintenance..............................................................................................7 7-1

7.1 Calibrating the Base Station screen............................................ 7-1

7.2 Cleaning and disinfection.......................................................... 7-1

7.2.1 Cleaning...................................................................... 7-1

7.2.2 Disinfection................................................................. 7-2

Troubleshooting.......................................................................................8 8-1

8.1 Base Station............................................................................... 8-1

8.2 DoseView and Cradle................................................................ 8-1

Product disposal.......................................................................................9 9-1

9.1 Introduction.............................................................................. 9-1

9.2 Passing the system on to another user........................................ 9-1

9.3 Final disposal of the system........................................................ 9-2

9.4 Fitting, removing, and disposing of batteries.............................. 9-3

Technical data..........................................................................................10 10-1

10.1 PDM radiology ........................................................................ 10-1

10.2 PDM memory........................................................................... 10-2

10.3 Base Station memory................................................................. 10-2

10.4 Dose data transfer from PDM to Base Station........................... 10-2

10.5 PDM and Base Station/DoseView memories............................. 10-3

10.6 Time management.................................................................... 10-4

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10.7 Technical Specifications............................................................. 10-4

10.7.1 Radio communication.................................................. 10-4

10.7.2 Base Station................................................................ 10-4

10.7.3 PDM........................................................................... 10-5

10.7.4 Cradle.......................................................................... 10-5

10.8 Security and privacy requirements.............................................. 10-6

Contents

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Introduction

About the DoseAware System

Figure 1.1 DoseAware System overview with Base Station 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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The DoseAware System can contain the following components:

•

Personal Dose Meter (PDM)

• Base Stations (display unit)

• DoseView (computer software)

• Dose Manager (computer software)

• Cradle (dock station used to connect PDMs and computer)

• PDM Rack (PDM storage)
The Base Station Package consists of:

• Base Station, power adaptor, MCS bracket and wall mount kit

• DoseView (CD)

• User manual (CD)

• Cradle, USB cable

About these Instructions for Use

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 an operator.

1.2

W A R N I N G

C A U T I O N

N O T E

1.2 About these Instructions for Use

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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 describe 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.

Intended use of the DoseAware System

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.

1.3

Intended use of the DoseAware System 1.3

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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.

Installation, use and operation of this DoseAware System is subject to the
law in the jurisdiction(s) in which the DoseAware System 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.

Compatibility

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.)

N O T E S

1.4

1.4 Compatibility

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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.

Compliance

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.

Training

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.

W A R N I N G

1.5

1.6

Compliance 1.5

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System requirements

DoseView has the following system requirements:

•

Operating systems: Windows Vista or Windows XP

• .NET 3.0

• At least one USB port available

• At least 1 GB of system memory available

• At least 40 GB hard drive with at least 15 GB of memory available

• Recommended screen resolution at least 1024 x 768

Other user manuals

• Dose Manager is described in a separate user manual, which can be found
on the CD delivered in the box together with the Dose Manager package.

• The PDMs are described in the PDM Quick Guide, a leaflet that is
delivered in the box together with the PDM.

1.7

1.8

1.7 System requirements

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Safety

Important safety directions

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.

2

2.1

W A R N I N G

W A R N I N G

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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.

Electrical safety

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.

W A R N I N G S

W A R N I N G

W A R N I N G

2.2

W A R N I N G

2.2 Electrical safety

2-2

Safety

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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.

Mechanical safety

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.

Explosion safety

• 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.

Fire safety

Use of electrical product in an environment for which it was not
designed can lead to fire or explosion.

2.3

W A R N I N G

2.4

W A R N I N G S

2.5

Mechanical safety 2.3

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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.

Electrostatic discharge (ESD)

• 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.

ESD can amount to a significant voltage, which may cause damage to PCBs
or other system components.

W A R N I N G

2.6

C A U T I O N S

2.6 Electrostatic discharge (ESD)

2-4

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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.

Electromagnetic Compatibility (EMC)

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.

2.7

Electromagnetic Compatibility (EMC) 2.7

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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.

Mobile phones and similar RF equipment

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.

2.7.1

C A U T I O N

2.7 Electromagnetic Compatibility (EMC)

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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.

Modality specific safety

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.

N O T E

2.8

W A R N I N G

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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:

2.9

2.9 Network safety, security and privacy

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http://www.healthcare.philips.com/main/support/productsecurity

Toxic or hazardous substances and elements

The following table details the toxic or hazardous substances and elements
which are present in the DoseAware systems.

Toxic or hazardous substances and elements

DoseAware
component

Lead (Pb) Mercury (Hg) Cadmium (Cd) Hexavalent

Chromium (Cr6+)

Polybrominated
Biphenyls (PBB)

Polybrominated
Diphenyl Ethers
(PBDE)

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:

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:

2.10

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http://www.healthcare.philips.com/main/about/Sustainability

Equipment label overview

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

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.

2.11

N O T E

2.11 Equipment label overview

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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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