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User Manual
English
Lumify Ultrasound System
Contents
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Contents
1 Read This First .......................................................................................................................................... 9
Intended Audience.......................................................................................................................................... 10
Intended Use................................................................................................................................................... 10
Warnings......................................................................................................................................................... 11
Warning Symbols ............................................................................................................................................ 12
User Information Components ....................................................................................................................... 12
User Information Conventions........................................................................................................................ 13
Upgrades and Updates ................................................................................................................................... 16
Supplies and Accessories ................................................................................................................................ 16
Customer Service ............................................................................................................................................ 17
Recycling, Reuse, and Disposal ....................................................................................................................... 17
2 Safety ..................................................................................................................................................... 19
Basic Safety ..................................................................................................................................................... 19
Electrical Safety............................................................................................................................................... 22
Defibrillators...................................................................................................................................... 25
Fire Safety.......................................................................................................................................... 26
Equipment Protection..................................................................................................................................... 26
Product Compatibility ..................................................................................................................................... 28
Symbols........................................................................................................................................................... 28
Biological Safety.............................................................................................................................................. 31
FDA Medical Alert on Latex ............................................................................................................... 33
ALARA Education Program ................................................................................................................ 35
Output Display................................................................................................................................... 38
Control Effects ................................................................................................................................... 42
Related Guidance Documents ........................................................................................................... 43
Contents
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Acoustic Output and Measurement .................................................................................................. 44
Acoustic Output Tables...................................................................................................................... 47
Acoustic Measurement Precision and Uncertainty ........................................................................... 48
Operator Safety .............................................................................................................................................. 49
Repetitive Strain Injury ..................................................................................................................... 49
Philips Transducers............................................................................................................................ 50
Glutaraldehyde Exposure .................................................................................................................. 50
Infection Control................................................................................................................................ 50
Electromagnetic Compatibility ....................................................................................................................... 51
Electrostatic Discharge Precautions .................................................................................................. 52
Electromagnetic Emissions ................................................................................................................ 53
Approved Cables for Electromagnetic Compliance ........................................................................... 54
Approved Transducers for Electromagnetic Compliance .................................................................. 54
Approved Accessories for Electromagnetic Compliance ................................................................... 55
Electromagnetic Immunity ................................................................................................................ 55
Electromagnetic Interference............................................................................................................ 58
Recommended Separation Distance ................................................................................................. 59
Avoiding Electromagnetic Interference............................................................................................. 61
Use Restrictions Due to Interference ................................................................................................ 62
3 System Overview.................................................................................................................................... 63
System Requirements..................................................................................................................................... 63
System Capabilities ......................................................................................................................................... 64
Measurements................................................................................................................................... 64
Transducer Types............................................................................................................................... 64
Indications for Use and Supporting Transducers............................................................................... 64
Patient Data Protection ..................................................................................................................... 65
Wireless Networking ......................................................................................................................... 66
System Components ....................................................................................................................................... 66
Data Storage ..................................................................................................................................... 67
System Settings............................................................................................................................................... 67
Contents
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4 Using the System .................................................................................................................................... 71
Downloading and Installing the Lumify App ................................................................................................... 71
Registration and Entitlement.......................................................................................................................... 71
Registering Your Transducers ......................................................................................................................... 72
Updating the Lumify App ................................................................................................................................ 72
Viewing the App Walkthrough........................................................................................................................ 72
Canceling Your Subscription ........................................................................................................................... 73
Turning the System On and Off....................................................................................................................... 73
Setting the System Time and Date.................................................................................................................. 74
Setting the Thermal Index Display .................................................................................................................. 74
Imaging Display............................................................................................................................................... 74
Quick Exams.................................................................................................................................................... 77
Starting Quick Exams ......................................................................................................................... 77
Connecting Transducers ................................................................................................................................. 78
Deleting Patient Data and Lumify Settings ..................................................................................................... 78
5 Performing an Exam ............................................................................................................................... 79
Starting New Exams ........................................................................................................................................ 79
Changing Presets During Exams...................................................................................................................... 79
Editing Patient Data ........................................................................................................................................ 80
Reviewing Saved Exams .................................................................................................................................. 80
Restarting a Paused Exam............................................................................................................................... 81
Imaging Modes ............................................................................................................................................... 81
2D Mode ............................................................................................................................................ 81
Using 2D Mode .................................................................................................................................. 81
Color Mode ....................................................................................................................................... 82
Using Color Mode .............................................................................................................................. 82
Imaging Features ............................................................................................................................................ 83
Contents
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AutoSCAN .......................................................................................................................................... 83
Zoom Magnification........................................................................................................................... 83
Performing a 2D Distance Measurement ....................................................................................................... 83
Measurement Accuracy .................................................................................................................................. 84
Measurement Accuracy Tables ...................................................................................................................... 85
Acquiring Images............................................................................................................................................. 85
Acquiring Loops .............................................................................................................................................. 86
Annotation ...................................................................................................................................................... 86
Adding Labels..................................................................................................................................... 86
Ending an Exam............................................................................................................................................... 87
6 Review.................................................................................................................................................... 89
Starting Review During an Exam..................................................................................................................... 89
Starting Review After an Exam ....................................................................................................................... 89
Navigating Thumbnails and Images ................................................................................................................ 89
Playing Loops .................................................................................................................................................. 90
E-mailing Images............................................................................................................................................. 91
Deleting Images and Loops ............................................................................................................................. 92
Exporting Exams.............................................................................................................................................. 92
E-mailing Exams .............................................................................................................................................. 93
Deleting Exams................................................................................................................................................ 94
Configuring Export Destinations ..................................................................................................................... 95
Export Destination Settings ............................................................................................................................ 95
Editing Export Destinations............................................................................................................................. 97
Viewing the Export Queue.............................................................................................................................. 98
Enabling DICOM Logging................................................................................................................................. 98
7 Transducers ............................................................................................................................................ 99
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Clinical Applications and Transducers............................................................................................................. 99
Transducer Maintenance.............................................................................................................................. 100
Acoustic Artifacts .......................................................................................................................................... 100
Transducer Covers ........................................................................................................................................ 103
Ultrasound Transmission Gels ...................................................................................................................... 104
Transducer Storage....................................................................................................................................... 105
Storage for Transport ..................................................................................................................... 106
Daily and Long-Term Storage .......................................................................................................... 106
Testing Transducers ...................................................................................................................................... 106
8 Transducer Care.................................................................................................................................... 107
Transducer Care and Operator Safety .......................................................................................................... 107
Latex Product Alert.......................................................................................................................... 112
Transducer Care Methods ............................................................................................................................ 113
Transducer and Cable Cleaning..................................................................................................................... 113
Cleaning a Transducer ..................................................................................................................... 115
Low-level Disinfecting of Transducers .......................................................................................................... 117
High-level Disinfecting of Transducers.......................................................................................................... 118
Minimizing the Effects of Residual Disinfectant .............................................................................. 120
Disinfectants Compatibility........................................................................................................................... 121
Disinfectants and Cleaning Solutions for Transducers .................................................................... 123
9 System Maintenance ............................................................................................................................ 133
Device Maintenance ..................................................................................................................................... 133
Transducer Maintenance.............................................................................................................................. 133
Sending System Logs..................................................................................................................................... 134
Viewing Audit Logs........................................................................................................................................ 135
Troubleshooting............................................................................................................................................ 135
Error Messages ............................................................................................................................................. 136
Contents
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For Assistance ............................................................................................................................................... 136
10 139Specifications........................................................................................................................................
System Specifications ................................................................................................................................... 139
Safety and Regulatory Requirements ........................................................................................................... 140
Index .................................................................................................................................................... 141
Read This First
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Read This First
CAUTION
United States federal law restricts this device to sale by or on the order of a physician.
This manual is intended to assist you with the safe and effective operation of your Philips
product. Before attempting to operate the product, read this manual and strictly observe all
warnings and cautions. Pay special attention to the information in the section.“Safety”
The user information for your Philips product describes the most extensive configuration of the
product, with the maximum number of options and accessories. Some functions described may
be unavailable on your product's configuration.
This document and the information contained in it is proprietary and confidential information
of Philips Healthcare ("Philips") and may not be reproduced, copied in whole or in part,
adapted, modified, disclosed to others, or disseminated without the prior written permission of
the Philips Legal Department. This document is intended to be used either by customers, and is
licensed to them as part of their Philips equipment purchase, or to meet regulatory
commitments as required by the FDA under 21 CFR 1020.30 (and any amendments to it) and
other local regulatory requirements. Use of this document by unauthorized persons is strictly
prohibited.
Philips provides this document without warranty of any kind, implied or expressed, including,
but not limited to, the implied warranties of merchantability and fitness for a particular
purpose.
Philips has taken care to ensure the accuracy of this document. However, Philips assumes no
liability for errors or omissions and reserves the right to make changes without further notice to
any products herein to improve reliability, function, or design. Philips may make improvements
or changes in the products or programs described in this document at any time.
1
Read This First Intended Audience
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Unauthorized copying of this document, in addition to infringing copyright, might reduce the
ability of Philips to provide accurate and current information to users.
Non-Philips product names may be trademarks of their respective owners.
Intended Audience
Before you use your user information, you need to be familiar with ultrasound techniques.
Sonography training and clinical procedures are not included here.
This document is intended for clinicians and biomedical engineers who operate and maintain
your Philips product.
Intended Use
The intended use of the product is diagnostic ultrasound imaging and fluid flow analysis of the
human body. The product shall provide the ability for gathering clinically acceptable images and
ultrasound data for the clinical applications and anatomies listed in the table provided in
“Clinical Applications and Transducers” on page 99. The clinical environments where the
product can be used include clinics, hospitals, and clinical point-of-care for diagnosis of
patients.
This product is intended to be installed, used, and operated only in accordance with the safety
procedures and operating instructions given in the product user information, and only for the
purposes for which it was designed. However, nothing stated in the user information reduces
your responsibility for sound clinical judgment and best clinical procedure.
The Lumify Ultrasound System is intended for diagnostic ultrasound imaging in B- (2D) mode
and in color Doppler (color flow). The system is indicated for diagnostic ultrasound imaging and
fluid flow analysis in the following applications: Fetal/Obstetric, Abdominal, Urology,
Gynecological, Cardiac Fetal, Small Organ, Musculoskeletal, Peripheral Vessel, and Carotid.
Lumify is intended for use in environments where healthcare is provided by healthcare
professionals, with the exception of home, ambulance, and air.
Warnings Read This First
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WARNING
Do not use the system for purposes other than those intended and expressly stated by
Philips. Do not misuse the system, and do not use or operate the system incorrectly.
Installation, use, and operation of this product are subject to the law in the jurisdictions in
which the product is used. Install, use, and operate the product in such ways that do notonly
conflict with applicable laws or regulations, which have the force of law.
Use of the product for purposes other than those intended and expressly stated by Philips, as
well as incorrect use or operation, may relieve Philips or its agents from all or some
responsibility for resultant noncompliance, damage, or injury.
WARNING
System users are responsible for image quality and diagnosis. Inspect the data that is being
used for the analysis and diagnosis, and ensure that the data is sufficient both spatially and
temporally for the measurement approach being used.
Warnings
Before using the system, read these warnings and the section.“Safety”
WARNING
Do not operate this system in the presence of flammable gases or anesthetics. Explosion can
result. The system is not compliant in AP/APG environments as defined by IEC 60601-1.
Read This First Warning Symbols
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WARNING
Medical equipment must be installed and put into service according to the special
electromagnetic compatibility (EMC) guidelines provided in the “Safety” section.
WARNING
The use of portable and mobile radio-frequency (RF) communications equipment can affect
the operation of medical equipment.
Warning Symbols
The system uses various warning symbols. For symbols used on the system, see “Symbols” on
page 28.
User Information Components
The user information provided with your product includes the following components:
• : Includes all of the user information, except the User Information CD Operating Notes.
• Operating Notes: Contains information that clarifies certain product responses that might
be misunderstood or cause user difficulty.
• : Provided with the product and included on the CD. The User Manual User Manual
introduces you to features and concepts, helps you set up your system, contains
comprehensive instructions for using the system and includes important safety information.
• : Included on the CD, it contains information about acoustic outputAcoustic Output Tables
and patient-applied part temperatures.
• : Included on the CD, it contains guidelines toShared Roles for System and Data Security
help you understand security recommendations for your Philips product and information on
Philips efforts to help you prevent security breaches.
User Information Conventions Read This First
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User Information Conventions
The user information for your product uses the following typographical conventions to assist
you in finding and understanding information:
• All procedures are numbered, and all subprocedures are lettered. You must complete steps
in the sequence they are presented to ensure success.
• Bulleted lists indicate general information about a particular function or procedure. They do
not imply a sequential procedure.
• Control names and menu items or titles are spelled as they are on the system, and they
appear in bold text.
• Symbols appear as they appear on the system.
• and refer to the combination of a Philips transducer, the PhilipsSystem ultrasound system
Lumify app, and a compatible Android device.
• refers to a Lumify-compatible Android device.Device
• refers to the Android operating system.Operating system
The following touch gestures are used to control your system.
Touch Gestures
Gesture Name Description
Drag Touch the screen with a finger and
move the finger across the screen
without lifting the finger.
User Information Conventions Read This First
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Gesture Name Description
Spread Touch the screen with two fingers
and move them apart.
Swipe Touch the screen with your finger
and move the finger in a quick
motion right, left, up, or down.
Information that is essential for the safe and effective use of your product appears throughout
your user information as follows:
WARNING
Warnings highlight information vital to the safety of you, the operator, and the patient.
CAUTION
Cautions highlight ways that you could damage the product and consequently void your
warranty or service contract or ways that you could lose patient or system data.
Customer Service Read This First
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Customer Service
Customer service representatives are available worldwide to answer questions and to provide
maintenance and service. Please contact your local Philips representative for assistance. You
can also visit the Lumify portal or contact the following office for referral to a customer service
representative:
www.philips.com/lumify
Philips Ultrasound Headquarters
22100 Bothell-Everett Highway, Bothell, WA 98021-8431, USA
800-722-9377
Recycling, Reuse, and Disposal
Philips is concerned with helping protect the natural environment and helping ensure
continued safe and effective use of this system through proper support, maintenance, and
training. Philips designs and manufactures equipment in compliance with relevant guidelines
for environmental protection. As long as the equipment is properly operated and maintained, it
presents no risk to the environment. However, the equipment may contain materials that could
be harmful to the environment if disposed of incorrectly. Use of such materials is essential for
the implementation of certain functions and for meeting certain statutory and other
requirements.
Recycling, reuse, and disposal information in this document is directed mainly at the entity with
legal authority over the equipment. Operators are usually uninvolved in disposal, except in the
case of certain batteries.
Final Disposal of Your System
Read This First Recycling, Reuse, and Disposal
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Final disposal is when you dispose of the device and transducer in such a way that they can no
longer be used for their intended purposes.
For information on proper disposal of your device, see the documentation that accompanies
your device.
WARNING
Do not dispose of the device or transducer with industrial or domestic waste. The system
may contain materials such as lead, tungsten, or oil, or other hazardous substances that can
cause serious environmental pollution. The device also contains privacy-sensitive
information, which should be properly removed (scrubbed). Philips advises you to contact
your Philips service organization before disposing of this system.
Philips Healthcare gives support for the following:
• Recovery of useful parts
• Recycling of useful materials by competent disposal companies
• Safe and effective disposal of equipment
For advice and information, contact your Philips service organization, or see the following
website:
www.healthcare.philips.com/us/about/sustainability/recycling
Basic Safety Safety
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Safety
Please read this information before using your ultrasound system. It applies to the device, the
transducers, and the software. This section covers general safety information only. Safety
information that applies only to a specific task is included in the procedure for that task.
The combination of a Philips transducer, the Philips Lumify app, and a compatible Android
device is considered a medical device. This device is intended for use by, or by the order of, and
under the supervision of a licensed physician qualified to direct the use of the device.
WARNING
Warnings highlight information vital to the safety of you, the operator, and the patient.
CAUTION
Cautions highlight ways that you could damage the product and consequently void your
warranty or service contract or ways that you could lose patient or system data.
Basic Safety
WARNING
Do not use the system for any application until you have read, understood, and know all the
safety information, safety procedures, and emergency procedures contained in this "Safety"
section. Operating the system without a proper awareness of safe use could lead to fatal or
other serious personal injury.
2
Safety Basic Safety
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WARNING
If any part of the system is known or suspected to be defective or incorrectly adjusted, do
not use the system until it is repaired. Operating the system with defective or incorrectly
adjusted components could expose you and the patient to safety hazards.
WARNING
Do not use the system for any application until you are adequately and properly trained on
its safe and effective operation. If you are unsure of your ability to operate the system
safely and effectively, do not use it. Operation of the system without proper and adequate
training could lead to fatal or other serious personal injury.
WARNING
Do not operate the system with patients unless you have an adequate understanding of its
capabilities and functions. Using the system without such understanding may compromise
the system's effectiveness and the safety of the patient, you, and others.
WARNING
Never attempt to remove, modify, override, or frustrate any safety device on the system.
Interfering with safety devices could lead to fatal or other serious personal injury.
WARNING
Use the system only for its intended purposes. Do not use the system with any product that
Philips does not recognize as compatible with the system. Operation of the product for
unintended purposes, or with incompatible products, could lead to fatal or other serious
injury.
Basic Safety Safety
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WARNING
Stop use immediately if the system or the transducer appear to be malfunctioning. Contact
your Philips representative immediately.
WARNING
You are responsible for configuring your device in accordance with your institution's security
policies. Notifications and alerts from third-party applications may interfere with an exam.
WARNING
Thin needles can bend when entering tissue. Actual position must be verified by identifying
the echoes from the needle.
WARNING
Do not perform a needle procedure if the needle is not visible.
WARNING
Reverberation or other tissue artifacts may produce false needle images, which can cause
confusion in locating the actual needle image. Ensure that you are not using a false needle
image to locate the needle.
Safety Electrical Safety
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Electrical Safety
The transducer and software, along with a representative device, have been verified a
compliant with IEC 60601-1. The transducers meet Type BF isolated applied part requirements.
When the transducer and software are used in conjunction with a device compliant with IEC
60950-1, the system meets IEC 60601-1 requirements for Class II/internally powered
equipment. (The safety standards met by this system are included in the “Specifications”
section.) For maximum safety, observe these warnings and cautions:
WARNING
Devices that are compliant with IEC 60950-1 have not been evaluated for compliance with
the IEC 60601-1 temperature limits for patient contact. Therefore, only the operator is
allowed to handle the device.
WARNING
Do not operate this system in the presence of flammable gases or anesthetics. Explosion can
result. The system is not compliant in AP/APG environments as defined by IEC 60601-1.
WARNING
To avoid risk of electrical shock hazards, always inspect the transducer before use. Check the
face, housing, and cable before use. Do not use if the face is cracked, chipped, or torn; the
housing is damaged; or the cable is abraded.
WARNING
All patient-contact devices, such as transducers, pencil probes, and ECG leads not specifically
indicated as defibrillation-proof, must be removed from patient contact before application
of a high-voltage defibrillation pulse. See “Defibrillators” on page 25.
Electrical Safety Safety
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WARNING
Ultrasound equipment in normal operation, as with other medical electronic diagnostic
equipment, uses high-frequency electrical signals that can interfere with pacemaker
operation. Though the possibility of interference is slight, be alert to this potential hazard
and stop system operation immediately if you note interference with a pacemaker.
WARNING
When using additional peripheral equipment that is to be interconnected by functional
connection, the combination is considered to be a medical electrical system. It is your
responsibility to comply with IEC 60601-1 and test the system to those requirements. If you
have questions, contact your Philips representative.
WARNING
Patient-applied parts meet the standard IEC 60601-1. Applied voltages exceeding the
standard, although unlikely, may result in electrical shock to the patient or operator.
WARNING
Connection of optional devices not supplied by Philips Ultrasound could result in electrical
shock. When such optional devices are connected to your ultrasound system, ensure that
the total system earth leakage current does not exceed 500 µA.
WARNING
To avoid risk of electrical shock, do not use any transducer that has been immersed beyond
the specified cleaning or disinfection level.
Safety Electrical Safety
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WARNING
Electrosurgical units (ESUs) and other devices intentionally introduce radio frequency
electromagnetic fields or currents into patients. Because imaging ultrasound frequencies are
coincidentally in the radio frequency range, ultrasound transducer circuits are susceptible to
radio frequency interference. While an ESU is in use, severe noise interferes with the black-
and-white image and completely obliterates the color image.
WARNING
To avoid risk of a burn hazard, do not use transducers with high-frequency surgical
equipment. A burn hazard may result from a defect in the high-frequency surgical neutral
electrode connection.
WARNING
Using cables, transducers, and accessories other than those specified for use with the
system may result in increased emissions from, or decreased immunity of, the system.
CAUTION
Use of the system in the presence of an electromagnetic field can cause momentary
degradation of the ultrasound image. When interference is present or intermittent, use
caution when continuing to use the system. If interference occurs often, review the
environment in which the system is being used to identify possible sources of radiated
emissions. These emissions could be from other electrical devices used within the same
room or an adjacent room. Communication devices such as cellular phones and pagers can
cause these emissions. The existence of radio, TV, or microwave transmission equipment
located nearby can cause emissions. In cases where EMI is causing disturbance, it may be
necessary to relocate your system.
Electrical Safety Safety
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CAUTION
For information on electromagnetic emissions and immunity as it applies to the system, see
“Electromagnetic Compatibility ” on page 51. Ensure that the operating environment of
your system meets the conditions specified in the referenced information. Operating the
system in an environment that does not meet those conditions may degrade system
performance.
Defibrillators
Observe the following warnings when a defibrillation is required while using the ultrasound
system.
WARNING
Before defibrillation, always remove all patient-applied parts from the patient.
WARNING
Before defibrillation, always disconnect invasive transducers that remain in contact with the
patient from the system.
WARNING
A disposable transducer cover provides no protective electrical insulation against
defibrillation.
Safety Equipment Protection
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WARNING
A small hole in the outer layer of the transducer opens a conductive path to grounded metal
parts of the transducer. The secondary arcing that could occur during defibrillation could
cause patient burns. The risk of burns is reduced, but not eliminated, by using an
ungrounded defibrillator.
Use defibrillators that do not have grounded patient circuits. To determine whether a
defibrillator patient circuit is grounded, see the defibrillator service guide, or consult a
biomedical engineer.
Fire Safety
WARNING
On electrical or chemical fires, use only extinguishers that are specifically labeled for those
purposes. Using water or other liquids on an electrical fire can lead to fatal or other serious
personal injury. Before attempting to fight a fire, if it is safe to do so, attempt to isolate the
product from electrical and other supplies, to reduce the risk of electrical shock.
Use of electrical products in an environment for which they were not designed can lead to fire
or explosion. 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
nonelectrical fires.
Equipment Protection
Follow these precautions to protect your system:
Equipment Protection Safety
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CAUTION
Excessive bending or twisting of cables on patient-applied parts may cause failure or
intermittent operation of the system.
CAUTION
In general, only the area of the transducer acoustic window is liquid-tight. Except where
specified in specific transducer-cleaning instructions, do not immerse the remainder of a
transducer in any liquid.
CAUTION
Do not submerge the transducer connector in solution. The cables and transducer bodies are
liquid‑
‑
‑
‑‑tight, but the connectors are not.
CAUTION
Do not use abrasive cleaners, or acetone, MEK, paint thinner, or other strong solvents on
the system, peripherals, or transducers.
CAUTION
If systems, transducers, and peripherals have been in an environment below 10°C (50°F),
allow them to reach room temperature before connecting or turning them on. Philips
recommends allowing 24 hours for complete normalization. Otherwise, condensation inside
the devices could cause damage. If the device was only briefly exposed to temperatures
below 10°C (50°F), then the time required for the device to return to room temperature
could be significantly less than 24 hours.
Safety Product Compatibility
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Product Compatibility
Do not use your system in combination with other products or components, unless Philips
expressly recognizes those other products or components as compatible. For information about
such products and components, contact your Philips representative.
Changes and additions to the system should be made only by Philips or by third parties
expressly authorized by Philips to do so. Such changes and additions must comply with all
applicable laws and regulations that have the force of law within the jurisdictions concerned,
and best engineering practices.
WARNING
System changes and additions that are made without the appropriate training or by using
unapproved spare parts may void the Philips warranty. As with all complex technical
products, maintenance by unqualified persons or using unapproved spare parts carries
serious risks of system damage and personal injury.
Symbols
The International Electrotechnical Commission (IEC) has established a set of symbols for
medical electronic equipment that classify a connection or warn of potential hazards. Of those
symbols, the following may be used on your Philips product and its accessories and packaging.
Symbol Description
USA federal law restricts this device to sale by or on the order of a physician.
Isolated patient connection (Type BF applied part).
Safety Symbols
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Symbol Description
Global Trade Item Number
Model name for the device.
Identifies the date of manufacture.
Identifies the legal manufacturer.
This side up: Points toward the side of the shipping crate that should be kept
facing up.
Indicates that the device should be kept dry.
Indicates that the device is fragile; handle with care.
Do not use if damaged.
Keep away from sunlight.
Biological Safety Safety
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Symbol Description
Non-sterile.
Catalog number.
Batch code.
Serial number.
Biological Safety
This section contains information about biological safety and a discussion of the prudent use of
the system.
A list of precautions related to biological safety follows; observe these precautions when using
the system. For more information, see on your CD.Medical Ultrasound Safety User Information
WARNING
Do not use the system if an error message on the display indicates that a hazardous
condition exists. Note the error code, turn off power to the system, and call your customer
service representative.
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WARNING
Do not use a system that exhibits erratic or inconsistent image updating. Discontinuities in
the scanning sequence indicate a hardware failure that must be corrected before use.
WARNING
Perform ultrasound procedures prudently. Use the ALARA (as low as reasonably achievable)
principle.
WARNING
Use only acoustic standoffs that have been approved by Philips Ultrasound. For information
on ordering approved accessories, see “Supplies and Accessories” on page 16.
WARNING
Transducer covers may contain natural rubber latex. Those covers may cause allergic
reactions in some individuals. See “FDA Medical Alert on Latex” on page 33.
WARNING
If a sterile transducer cover becomes compromised during an intraoperative application
involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-
Jakob disease, follow the guidelines of the U.S. Centers for Disease Control and this
document from the World Health Organization: WHO/CDS/ APH/2000/3, WHO Infection
Control Guidelines for Transmissible Spongiform Encephalopathies. The transducers for your
system cannot be decontaminated using a heat process.
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WARNING
If the system becomes contaminated internally with bodily fluids carrying pathogens, you
must immediately notify your Philips service representative. Components inside the system
cannot be disinfected. In that case, the system must be disposed of as biohazardous
material in accordance with local or federal laws.
WARNING
Select the correct application when starting an exam, and remain in that application
throughout the exam. Some applications are for parts of the body that require lower limits
for acoustic output.
FDA Medical Alert on Latex
March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices
Because of reports of severe allergic reactions to medical devices containing latex (natural
rubber), the FDA is advising health care professionals to identify their latex sensitive patients
and be prepared to treat allergic reactions promptly. Patient reactions to latex have ranged
from contact urticaria to systemic anaphylaxis. Latex is a component of many medical devices,
including surgical and examination gloves, catheters, intubation tubes, anesthesia masks, and
dental dams.
Reports to the FDA of allergic reactions to latex-containing medical devices have increased
lately. One brand of latex cuffed enema tips was recently recalled after several patients died as
a result of anaphylactoid reactions during barium enema procedures. More reports of latex
sensitivity have also been found in the medical literature. Repeated exposure to latex both in
medical devices and in other consumer products may be part of the reason that the prevalence
of latex sensitivity appears to be increasing. For example, it has been reported that 6% to 7% of
surgical personnel and 18% to 40% of spina bifida patients are latex sensitive.
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Proteins in the latex itself appear to be the primary source of the allergic reactions. Although it
is not now known how much protein is likely to cause severe reactions, the FDA is working with
manufacturers of latex-containing medical devices to make protein levels in their products as
low as possible.
FDA’s recommendations to health professionals in regard to this problem are as follows:
• When taking general histories of patients, include questions about latex sensitivity. For
surgical and radiology patients, spina bifida patients and health care workers, this
recommendation is especially important. Questions about itching, rash or wheezing after
wearing latex gloves or inflating a toy balloon may be useful. Patients with positive histories
should have their charts flagged.
• If latex sensitivity is suspected, consider using devices made with alternative materials, such
as plastic. For example, a health professional could wear a non-latex glove over the latex
glove if the patient is sensitive. If both the health professional and the patient are sensitive,
a latex middle glove could be used. (Latex gloves labeled “Hypoallergenic” may not always
prevent adverse reactions.)
• Whenever latex-containing medical devices are used, especially when the latex comes in
contact with mucous membranes, be alert to the possibility of an allergic reaction.
• If an allergic reaction does occur and latex is suspected, advise the patient of a possible
latex sensitivity and consider an immunologic evaluation.
• Advise the patient to tell health professionals and emergency personnel about any known
latex sensitivity before undergoing medical procedures. Consider advising patients with
severe latex sensitivity to wear a medical identification bracelet.
The FDA is asking health professionals to report incidents of adverse reactions to latex or other
materials used in medical devices. (See the October 1990 FDA Drug Bulletin.) To report an
incident, contact the FDA Problem Reporting Program, MedWatch, at 1-800-332-1088, or on
the Internet:
www.fda.gov/Safety/MedWatch/
For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220, Rockville,
MD 20857.
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manual selection. Ultimately, the user has the responsibility for proper clinical use. The
ultrasound system provides both automatic (default) settings and manual (user-selectable)
settings.
Output power has direct impact on acoustic intensity. Once the application has been
established, the power control can be used to increase or decrease the intensity output. The
power control allows you to select intensity levels less than the established maximum. Prudent
use dictates that you select the lowest output intensity that is consistent with good image
quality.
Indirect Controls
The indirect controls are those that have an indirect effect on acoustic intensity. These controls
affect imaging mode, focus depth, and transducer selection.
The choice of imaging mode determines the nature of the ultrasound beam. 2D is a scanning
mode; Doppler is a stationary or unscanned mode. A stationary ultrasound beam concentrates
energy in a single location. A moving or scanned ultrasound beam disperses the energy over an
area and the beam is concentrated on the same area for a fraction of the time as that of an
unscanned mode.
Focus of the ultrasound beam affects the image resolution. To maintain or increase resolution
at a different focus requires a variation in output over the focal zone. This variation of output is
a function of system optimization. Different exams require different focal depths. Setting the
focus at the proper depth improves the resolution of the structure of interest.
Transducer selection indirectly affects intensity. Tissue attenuation changes with frequency.
The higher the transducer operating frequency, the greater the attenuation of the ultrasonic
energy. A higher transducer operating frequency requires more output intensity to scan at a
deeper depth. To scan deeper at the same output intensity, a lower transducer frequency is
required. Using more gain and output beyond a point, without corresponding increases in
image quality, can mean that a lower frequency transducer is needed.
Receiver Controls
Receiver controls are used by the operator to improve image quality. These controls have no
effect on output. Receiver controls only affect how the ultrasound echo is received. These
controls include gain, time gain compensation (TGC), dynamic range, and image processing. The
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important thing to remember, relative to output, is that receiver controls should be optimized
before output is increased. For example, before increasing output, optimize gain to improve
image quality.
An Example of Applying the ALARA Principle
An ultrasound scan of a patient’s liver begins with selecting the appropriate transducer
frequency. After selecting the transducer and the application, which are based on patient
anatomy, adjustments to output power should be made to ensure that the lowest possible
setting is used to acquire an image. After the image is acquired, adjusting the focus of the
transducer, and then increasing the receiver gain to produce a uniform representation of the
tissue follows. If an adequate image can be obtained with the increase in gain, then a decrease
in output should be made. Only after making these adjustments should you increase output to
the next level.
Having acquired the 2D display of the liver, Color can be used to localize blood flow. As with the
2D image display, gain and image processing controls must be optimized before increasing
output.
In summary: Select the correct transducer frequency and application for the job; start with a
low output level; and optimize the image by using focus, receiver gain, and other imaging
controls. If the image is not diagnostically useful at this point, then increase output.
Additional Considerations
Ensure that scanning time is kept to a minimum, and ensure that only medically required
scanning is performed. Never compromise quality by rushing through an exam. A poor exam
may require a follow up, which ultimately increases exposure time. Diagnostic ultrasound is an‑
important tool in medicine, and like any tool, it should be used efficiently and effectively.
Output Display
The system output display comprises two basic indices: a mechanical index and a thermal index.
The mechanical index is continuously displayed over the range of 0.0 to 1.9, in increments of
0.1.
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The thermal index further consists of the following indices: soft tissue (TIS), bone (TIB), and
cranial bone (TIC). Only one of these is displayed at any time. Each transducer application has a
default selection that is appropriate for that combination. The TIB, TIS, or TIC is continuously
displayed over the range of 0.0 to maximum output, based on the transducer and application,
in increments of 0.1. For the location of the output display, see .“Imaging Display” on page 74
The application-specific nature of the default setting is also an important factor of index
behavior. A default setting is a system control state that is preset by the manufacturer or the
operator. The system has default index settings for the transducer application. The default
settings are invoked automatically by the ultrasound system when power is turned on, when
new patient data is entered into the system database, or when an application change occurs.
The decision as to which of the three thermal indices to display should be based on the
following criteria:
• Appropriate index for the application: TIS is used for imaging soft tissue, TIB for a focus at or
near bone, and TIC for imaging through bone near the surface, as in a cranial exam.
• Mitigating factors that might create artificially high or low thermal index readings: location
of fluid or bone, or blood flow. For example, is there a highly attenuating tissue path so that
the actual potential for local zone heating is less than the thermal index displays?
• Scanned modes versus unscanned modes of operation affect the thermal index. For
scanned modes, heating tends to be near the surface; for unscanned modes, the potential
for heating tends to be deeper in the focal zone.
• Always limit ultrasound exposure time. Do not rush the exam. Ensure that the indices are
kept to a minimum and that exposure time is limited without compromising diagnostic
sensitivity.
Mechanical Index (MI) Display
Mechanical bioeffects are threshold phenomena that occur when a certain level of output is
exceeded. The threshold level varies, however, with the type of tissue. The potential for
mechanical bioeffects varies with peak rarefactional pressure and ultrasound frequency. The MI
accounts for these two factors. The higher the MI value, the greater the likelihood of
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mechanical bioeffects occurring. There is no specific MI value that means that a mechanical
effect is actually occurring. The MI should be used as a guide for implementing the ALARA
principle.
Thermal Index (TI) Displays
The TI informs the user about the conditions that exist that might lead to an increase in
temperature at the surface of the body, within the body tissue, or at the point of focus of the
ultrasound beam on bone. That is, the TI informs the user of the potential for temperature rise
in body tissue. It is an estimate of temperature increase in body tissue with specific properties.
The actual amount of any temperature rise is influenced by factors such as tissue type,
vascularity, mode of operation, and others. The TI should be used as a guide for implementing
the ALARA principle.
The bone thermal index (TIB) informs the user about potential heating at or near the focus after
the ultrasound beam has passed through soft tissue or fluid; for example, at or near second- or
third-trimester fetal bone.
The cranial bone thermal index (TIC) informs the user about the potential heating of bone at or
near the surface; for example, cranial bone.
The soft tissue thermal index (TIS) informs the user about the potential for heating within soft
homogeneous tissue.
but
You can choose to display TIS, TIC, or TIB. For details on changing the TI display, see “Setting the
Thermal Index Display” on page 74.
Mechanical and Thermal Indices Display Precision and Accuracy
The MI and TI precision is 0.1 unit on the system.
The MI and TI display accuracy estimates for the system are given in , onAcoustic Output Tables
your CD. Those accuracy estimates are based on the variability range ofUser Information
transducers and systems, inherent acoustic output modeling errors, and measurement
variability, as discussed in this section.
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The displayed values should be interpreted as relative information to help the system operator
achieve the ALARA principle through prudent use of the system. The values should not be
interpreted as actual physical values in interrogated tissue or organs. The initial data that is
used to support the output display is derived from laboratory measurements based on the
American Institute of Ultrasound in Medicine (AIUM) measurement standard. The
measurements are then put into algorithms for calculating the displayed output values.
Many of the assumptions used in the process of measurement and calculation are conservative
in nature. Overestimation of actual intensity exposure, for the vast majority of tissuein situ
paths, is built into the measurement and calculation process. For example:
• The measured water tank values are derated using a conservative, industry standard,
attenuation coefficient of 0.3 dB/cm MHz.‑
• Conservative values for tissue characteristics were selected for use in the TI models.
Conservative values for tissue or bone absorption rates, blood perfusion rates, blood heat
capacity, and tissue thermal conductivity were selected.
• Steady State temperature rise is assumed in the industry standard TI models, and the
assumption is made that the ultrasound transducer is held steady in one position long
enough for steady state to be reached.
A number of factors are considered when estimating the accuracy of the displayed values:
hardware variations, estimation algorithm accuracy, and measurement variability. Variability
among transducers and systems is a significant factor. Transducer variability results from
piezoelectric crystal efficiencies, process-related impedance differences, and sensitive lens-
focusing parameter variations. Differences in system pulser voltage control and efficiencies is
also a contributor to variability. There are inherent uncertainties in the algorithms used to
estimate acoustic output values over the range of possible system operating conditions and
pulser voltages. Inaccuracies in laboratory measurements are related to, among others,
differences in hydrophone calibration and performance, positioning, alignment, and digitization
tolerances, and variability among test operators.
The conservative assumptions of the output estimation algorithms of linear propagation, at all
depths, through a 0.3 dB/cm MHz attenuative medium is not considered in the accuracy‑
estimate for the display. Neither linear propagation, nor uniform attenuation at the 0.3 dB/
cm MHz rate, occur in water tank measurements or in most tissue paths in the body. In the‑
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body, different tissues and organs have dissimilar attenuation characteristics. In water, there is
almost no attenuation. In the body, and in particular, in water tank measurements, nonlinear
propagation and saturation losses occur as pulser voltages increase.
Therefore, the display accuracy estimates are based on the variability range of transducers and
systems, inherent acoustic output modeling errors, and measurement variability. Display
accuracy estimates are not based on errors in, or caused by measuring according to, the AIUM
measurement standards, or the effects of nonlinear loss on the measured values.
Control Effects
Controls Affecting the Indices
As various system controls are adjusted, the TI and MI values may change. This will be most
apparent as the output power control is adjusted; but other system controls affect the
on screen output values.
Power
The output power control affects the system acoustic output. Two real time output values are
on the display: TI and MI. They change as the system responds to power-control adjustments.
In combined modes, such as simultaneous Color and 2D, the individual modes each add to the
total TI. One mode will be the dominant contributor to this total. The displayed MI will be from
the mode with the largest MI value.
2D Controls
•Focus: Changing the focal depth will change MI. Generally, higher MI values will occur when
the focal depth is near the natural focus of the transducer.
• Increasing the zoom magnification by spreading the display may increase frame rate.Zoom:
This action will increase the TI. The number of focal zones may also increase automatically
to improve resolution. This action may change the MI, because the peak MI can occur at a
different depth.
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Color Controls
•Color Sector Width: Narrower color sector width will increase color frame rate and the TI
will increase. The system may automatically decrease pulser voltage to stay below the
system maximum. A decrease in pulser voltage will decrease the MI.
• Deeper color sector depth may automatically decrease color frame rateColor Sector Depth:
or select a new color focal zone or color pulse length. The TI will change due to the
combination of these effects. Generally, the TI will decrease with increased color sector
depth. MI will correspond to the MI of the dominant pulse type which is a color pulse.
Other Control Effects
•2D Depth: An increase in 2D depth will automatically decrease the 2D frame rate. This will
decrease the TI. The system may also automatically choose a deeper 2D focal depth. A
change of focal depth may change the MI. The MI displayed is that of the zone with the
largest MI value.
• Acoustic output defaults are set when you select an application. FactoryApplication:
defaults vary with transducer, application, and mode. Defaults have been chosen below the
FDA limits for intended use.
• When a new imaging mode is selected, both the TI and MI mayImaging Mode Controls:
change to default settings. Each mode has a corresponding pulse repetition frequency and
maximum intensity point. In combined or simultaneous modes, the TI is the sum of the
contribution from the modes enabled, and the displayed MI is the largest of the MI values
associated with each mode and focal zone enabled. The system will return to the previously
selected state if a mode is turned off and then reselected.
• Each transducer type has unique specifications for contact area, beam shape,Transducer:
and center frequency. Defaults are initialized when you select a transducer. Factory defaults
vary with transducer, application, and selected mode. Defaults have been chosen below the
FDA limits for intended use.
Related Guidance Documents
For more information about ultrasonic bioeffects and related topics, see the following:
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• "Bioeffects and Safety of Diagnostic Ultrasound." AIUM Report, January 28, 1993.
• "American Institute of Ultrasound in Medicine Bioeffects Consensus Report." Journal of
Ultrasound in Medicine, Vol. 27, Issue 4, April 2008.
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM,
NEMA, 2004)
• Third Edition of the AIUM Medical Ultrasound Safety brochure, 2014. (A copy of this
document is provided with each system.)
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers. FDA, September 2008.
• Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment. (AIUM, NEMA, 2004)
• WFUMB. "Symposium on Safety of Ultrasound in Medicine: Conclusions and
Recommendations on Thermal and Non Thermal Mechanisms for Biological Effects of
Ultrasound." , 1998: Vol. 24, Supplement 1.Ultrasound in Medicine and Biology
Acoustic Output and Measurement
Since the initial use of diagnostic ultrasound, the possible human bioeffects from ultrasound
exposure have been studied by various scientific and medical institutions. In October 1987, the
American Institute of Ultrasound in Medicine (AIUM) ratified a report prepared by its Bioeffects
Committee ("Bioeffects Considerations for the Safety of Diagnostic Ultrasound." Journal of
Ultrasound in Medicine, Vol. 7, No. 9 Supplement, September 1988), sometimes referred to as
the Stowe Report, which reviewed available data on possible effects of ultrasound exposure.
Another report, “Bioeffects and Safety of Diagnostic Ultrasound,” dated January 28, 1993,
provides more-current information.
The acoustic output for this system has been measured and calculated in accordance with the
“Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (Revision 3,
AIUM, NEMA, 2004), the “Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment” (Revision 2, AIUM, NEMA, 2004), and the
September 2008 FDA document "Information for Manufacturers Seeking Marketing Clearance
of Diagnostic Ultrasound Systems and Transducers."
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In Situ, Derated, and Water Value Intensities
All intensity parameters are measured in water. Since water absorbs very little acoustic energy,
these water measurements represent a worst case value. Biological tissue does absorb acoustic
energy. The true value of the intensity at any point depends on the amount and type of tissue
and the frequency of the ultrasound that passes through the tissue. The intensity value in the
tissue, , has been estimated by using the following formula:In Situ
In Situ = Water [e-0.23alf]
Where:
Variable Value
In Situ In Situ intensity value
Water Water value intensity
e2.7183
aAttenuation factor
Tissue a(dB/cm-MHz)
Amniotic Fluid 0.006
Brain 0.53
Heart 0.66
Kidney 0.79
Liver 0.43
Muscle 0.55
lSkin line to measurement depth (cm)
fCenter frequency of the transducer/system/mode combination (MHz)
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Since the ultrasonic path during an examination is likely to pass through varying lengths and
types of tissue, it is difficult to estimate the true intensity. An attenuation factor of 0.3 isin situ
used for general reporting purposes; therefore, the value which is commonly reportedIn Situ
uses the formula:
In Situ derated = Water [e-0.069lf]
Since this value is not the true intensity, the term “derated” is used.in situ
Mathematical derating of water based measurements using the 0.3 dB/cm MHz coefficient may
yield lower acoustic exposure values than would be measured in a homogenous 0.3 dB/
cm MHz tissue. This is true because nonlinearly propagating acoustic energy waveforms
experience more distortion, saturation, and absorption in water than in tissue, where
attenuation present all along the tissue path will dampen the buildup of nonlinear effects.
The maximum derated and the maximum water values do not always occur at the same
operating conditions; therefore, the reported maximum water and derated values may not be
related by the (derated) formula. For example: A multi-zone array transducer that hasin situ
maximum water value intensities in its deepest zone may have its largest derated intensity in
one of its shallowest focal zones.
Conclusions Regarding Tissue Models and Equipment Survey
Tissue models are necessary to estimate attenuation and acoustic exposure levels fromin situ
measurements of acoustic output made in water. Presently, available models may be limited in
their accuracy because of varying tissue paths during diagnostic ultrasound exposures and
uncertainties in acoustical properties of soft tissues. No single tissue model is adequate for
predicting exposures in all situations from measurements made in water, and continued
improvement and verification of these models is necessary for making exposure assessments
for specific applications.
A homogeneous tissue model with an attenuation coefficient of 0.3 dB/cm MHz throughout the
beam path is commonly used when estimating exposure levels. The model is conservative in
that it overestimates the acoustic exposure when the path between the transducer andin situ
the site of interest is composed entirely of soft tissue, because the attenuation coefficient of
soft tissue is generally higher than 0.3 dB/cm MHz. When the path contains significant amounts
of fluid, as in many first- and second-trimester pregnancies scanned transabdominally, this
model may underestimate the acoustical exposure. The amount of underestimationin situ
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depends on each specific situation. For example, when the beam path is longer than 3 cm and
the propagation medium is predominantly fluid (conditions that may exist during
transabdominal OB scans), a more accurate value for the derating term is 0.1 dB/cm MHz.
Fixed-path tissue models, in which soft tissue thickness is held constant, sometimes are used to
estimate acoustical exposures when the beam path is longer than 3 cm and consistsin situ
largely of fluid. When this model is used to estimate maximum exposure to the fetus during
transabdominal scans, a value of 1 dB/cm MHz may be used during all trimesters.
The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad
range of values:
• A survey of 1990-equipment models yielded mechanical index (MI) values between 0.1 and
1 at their highest output settings. Maximum MI values of approximately 2 are known to
occur for currently available equipment. Maximum MI values are similar for real-time 2D,
M-mode, PW Doppler, and Color flow imaging.
• Computed estimates of upper limits to temperature elevations during transabdominal scans
were obtained in a survey of 1988 and 1990 PW Doppler equipment. The vast majority of
models yielded upper limits less than 1°C and 4°C for exposures of first-trimester fetal
tissue and second-trimester fetal bone, respectively. The largest values obtained were
approximately 1.5°C for first-trimester fetal tissue and 7°C for second-trimester fetal bone.
Estimated maximum temperature elevations given here are for a “fixed-path” tissue model
and are for devices having Ispta (derated) values greater than 500 mW/cm2. The
temperature elevations for fetal bone and tissue were computed based on calculation
procedures given in Sections 4.3.2.1 through 4.3.2.6 in "Bioeffects and Safety of Diagnostic
Ultrasound" (AIUM Report, January 28, 1993).
Acoustic Output Tables
Acoustic output tables are in , on your CD.Acoustic Output Tables User Information
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Acoustic Measurement Precision and Uncertainty
All table entries have been obtained at the same operating conditions that give rise to the
maximum index value in the first column of the tables. Measurement precision and uncertainty
for power, pressure, intensity, and center frequency are listed in the following tables.
NOTE
Per Section 6.4 of the Output Display Standard, measurement precision on the following
quantities is determined by making repeated measurements and stating the standard
deviation as a percentage.
Acoustic Measurement Precision
Quantity Precision (Percentage Standard Deviation)
Pr is the underated peak rarefactional pressure
measured in megapascals (MPa).
Pr: 5.4%
Wo is the ultrasonic power in milliwatts (mW). 6.2%
fc is the center frequency in megahertz (MHz)
(NEMA UD-2 definition).
<1%
PII.3 is the derated spatial-peak pulse intensity
integral in joules per square centimeter (J/cm2).
PII.3: 3.2%
Acoustic Measurement Uncertainty
Quantity Measurement Uncertainty (Percentage, 95%
Confidence Value)
Pr is the underated peak rarefactional pressure
measured in megapascals (MPa).
Pr: ±11.3%
Wo is the ultrasonic power in milliwatts (mW). ±10%
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CAUTION
Medical equipment has special precautions regarding EMC and must be installed and put
into service according to the EMC information provided in the system’s accompanying
documents.
This section includes information on electromagnetic emissions and immunity as it applies to
the system. Ensure that the operating environment of your system meets the conditions
specified in the referenced information. Operating the system in an environment that does not
meet these conditions may degrade system performance.
The information and warnings contained in this and other sections should be observed when
installing and using the system to ensure its EMC.
NOTE
See the other electrical-safety warnings and cautions in this section.
Electrostatic Discharge Precautions
Electrostatic discharge (ESD), commonly referred to as a static shock, is a naturally occurring
phenomenon that results in the flow of an electrical charge from a higher charged object or
person to a lower charged object or person. ESD is most prevalent during conditions of low
humidity, which can be caused by heating or air-conditioning. During low humidity conditions,
electrical charges naturally build up on individuals and objects and can create static discharges.
The following cautions can help to reduce ESD effect:
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CAUTION
The following precautions can help to reduce ESD: anti-static spray on carpets; anti-static
spray on linoleum; anti-static mats; or a ground wire connection between the system and
the patient table or bed.
CAUTION
On connectors labeled with the ESD sensitivity symbol , do not touch the connector pins,
and always observe the preceding ESD precautions when handling or connecting
transducers.
Electromagnetic Emissions
The system is intended for use in the electromagnetic environment specified in the table. The
customer or the user of the system should ensure that it is used in such an environment.
Electromagnetic Emissions: Environment Guidance
Emissions Test Compliance Electromagnetic Environment
Guidance
RF emissions, CISPR 11 Group 1 The system uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF emissions, CISPR 11 Class A The system is suitable for use in all
establishments, except domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions, IEC 61000-3-2 Class A
Voltage fluctuations/flicker
emissions, IEC 61000-3-3
Complies
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NOTE
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Electromagnetic Immunity: Environment Guidance
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment Guidance
Electrostatic discharge
(ESD), IEC 61000-4-2
8 kV air discharge, 6 kV
contact discharge
8 kV air discharge, 6 kV
contact discharge
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast transient/
burst, IEC 61000-4-4
Not applicable. The device
does not function on AC
power
- - Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge, IEC 61000-4-5 Not applicable. The device
does not function on AC
power
- - Mains power quality should
be that of a typical
commercial or hospital
environment.
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Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment Guidance
Voltage dips, short
interruptions, and voltage
variations on power supply
input lines, IEC 61000-4-11
Not applicable. The device
does not function on AC
power
- - Mains power quality should
be that of a typical
commercial or hospital
environment. If you require
continued operation during
power mains interruptions,
Philips recommends that
the system be powered
from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz) magnetic field,
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Conducted RF,
IEC 61000-4-6
3 Vrms 3 Vrms For recommended
separation distances, see
“Recommended Separation
Distance” on page 59.
Radiated RF, IEC 61000-4-3 3 V/m 3 V/m For recommended
separation distances, see
“Recommended Separation
Distance” on page 59.
Although most remote devices comply with their applicable standards for immunity, those
device requirements may not be as stringent as those required for medical equipment. It is the
responsibility of the installer and the user of this remote customer-supplied equipment to
ensure that it functions properly in the electromagnetic environment where the system is
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installed. Philips suggests that the installer or the user of such a system consult with experts in
the field of electromagnetic compatibility and safety for guidance to ensure the safe and
effective use of the created system.
Electromagnetic Interference
Electromagnetic interference may appear in many ways on the system and depends on the
mode the equipment is operating in, the imaging control settings, the type of transducer being
used, the type of electromagnetic phenomena, and the intensity level of the phenomena.
CAUTION
When interference is present or intermittent, use caution when continuing to use the
system.
NOTE
Electromagnetic phenomena are not always present and may be transitory in nature. It may
be extremely difficult to identify the source of the interference.
NOTE
The following table describes a few typical interferences seen in imaging systems. It is
impossible to describe all manifestations of interference, because it depends on many
parameters of the transmitting device, such as the type of modulation used by the signal
carrier, the source type, and the transmitted level. It is also possible for the interference to
degrade the imaging system's performance and not be visible in the image. If the diagnostic
results are suspicious, other means should be used to confirm the diagnosis.
Electromagnetic Compatibility Safety
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Typical Interference on Ultrasonic Imaging Systems
Imaging Mode ESD1RF2Power Line3
2D Change of operating mode,
system settings, or system
reset. Brief flashes in the
displayed or recorded
image.
For sector imaging
transducers, white radial
bands or flashes in the
center lines of the image.
For linear imaging
transducers, white vertical
bands, sometimes more
pronounced on the sides of
the image.
White dots, dashes, or
diagonal lines near the
center of the image.
Color Change of operating mode,
system settings, or system
reset. Brief flashes in the
displayed or recorded
image.
Color flashes, radial or
vertical bands, increase in
background noise, or
changes in image color.
Color flashes, dots, dashes,
or changes in the color
noise level.
1. Electrostatic discharge (ESD) caused by discharging of electric charge buildup on insulated
surfaces or persons.
2. Radio frequency (RF) energy from RF transmitting equipment such as portable phones,
handheld radios, wireless devices, commercial radio and TV stations, and so on.
3. Conducted interference on power lines or connected cables caused by other equipment,
such as switching power supplies, electrical controls, and natural phenomena such as
lightning.
Recommended Separation Distance
The following table provides recommended separation distances, which are guidelines on the
distances that any RF transmitting equipment should be kept away from the ultrasound system
to reduce the risk of interference with the system. Portable and mobile RF communications
equipment should be used no closer to any part of the system, including cables, than the
recommended separation distance calculated from the equation applicable to the frequency of
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the transmitter. Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the compliance level in each frequency range
as noted in the table. Interference may occur in the vicinity of equipment marked with the
following symbol: .
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the system is used exceeds the applicable
RF compliance level in the table, the system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the system.
NOTE
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE
The recommended separation distance guidelines in the following table may not apply to all
situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
The information provided here, in conjunction with ,“Electromagnetic Interference” on page 58
provides guidance on conducted and radiated interference from portable and fixed RF
transmitting equipment.
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Recommended Separation Distances by Transmitter Frequency
Rated Maximum Output
Power of Transmitter
(Watts)
150 kHz to 80 MHz 80 to 800 MHz 800 MHz to 2.5 GHz
0.01 0.35 m (13.8 in) 0.12 m (4.7 in) 0.23 m (9.1 in)
0.1 1.1 m (3.6 ft ) 0.38 m (15 in ) 0.73 m (28.7 in)
1 3.5 m (11.5 ft) 1.2 m (3.9 ft) 2.3 m (7.5 ft )
10 11 m (36.1 ft ) 3.8 m (12.5 ft ) 7.3 m (24 ft )
100 35 m (114.8 ft) 12 m (39.4 ft) 23 m (75.5 ft )
Ultrasound systems can be sensitive to RF interference in the transducer passband. For
example, for a 5-MHz imaging transducer, the frequency range of interference from a 3-V/m
field may be from 2 to 10 MHz and manifest itself as described in “Electromagnetic
Interference” on page 58.
As an example, if a portable transmitter has maximum radiated power of 1 W and an operating
frequency of 156 MHz, it should only be operated at distances greater than 1.2 m (3.9 ft) from
the system. Likewise, a 0.01-W Bluetooth wireless LAN device operating at 2.4 GHz should be
placed no closer than 0.24 m (9.5 in) from any part of the system.
Avoiding Electromagnetic Interference
A medical device can either generate or receive electromagnetic interference. The EMC
standards describe tests for both emitted and received interference. Emission tests deal with
interference generated by the device being tested. Philips ultrasound systems do not generate
interference based on the tests described in the referenced standards.
An ultrasound system is designed to receive signals at radio frequencies and is therefore
susceptible to interference generated by RF energy sources. Examples of other sources of
interference are medical devices, information technology products, and radio and television
transmission towers. Tracing the source of radiated interference can be a difficult task.
Customers should consider the following in an attempt to locate the source:
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• Is the interference intermittent or constant?
• Does the interference show up only with one transducer or with several transducers?
• Do two different transducers operating at the same frequency have the same problem?
• Is the interference present if the system is moved to a different location in the facility?
• Can the EMC coupling path be attenuated? For example, placement of a transducer or
printer close to an ECG cable can increase electromagnetic interference. Moving the cable
or other medical equipment away from the location of the transducer or printer can result
in reduced electromagnetic interference.
The answers to these questions will help determine if the problem resides with the system or
the scanning environment. After you answer the questions, contact your Philips service
representative.
Use Restrictions Due to Interference
The physician must determine if an artifact caused by radiated interference will have a negative
impact on image quality and the subsequent diagnosis.
System Requirements System Overview
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System Overview
Use this section to acquaint yourself with the ultrasound system and its components.
System Requirements
WARNING
Using the Lumify application on a device that does not meet the minimum specification may
result in poor image quality, unexpected results, and possible misdiagnosis.
For a list of devices that Philips has tested and determined to be compatible with the Lumify
app, visit the Lumify portal: www.philips.com/lumify.
Although Philips does not recommend other devices, these are minimum device specifications:
• Minimum 50 MB of storage space (plus more for patient data storage)
• Color display, minimum 15 cm (6 in)
• Touch interface
• Internally mounted speakers
• IEC 60950-1-compliant
• Date/time configuration
• Full compliance with USB On-The-Go standard
• 1280 x 800 resolution (minimum)
• Android 4.3 or later operating system
• NVIDIA Tegra3 Quad-Core CPU, 1.2 GHz (minimum)
• Wireless or cellular networking capability
• Access to ports 80 and 443
3
System Overview System Capabilities
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System Capabilities
The Lumify Ultrasound System is intended for abdominal, gallbladder, general imaging, lung,
musculoskeletal, OB/GYN, small parts, superficial, and vascular applications. It can be used for
2D and Color imaging. The system provides a 2D distance measurement tool.
NOTE
Voice-to-text capability depends upon your device's support for the feature and on your
wireless or cellular connection.
Measurements
The system provides tools for measuring distance.
After you perform measurements, you can save the measurement by acquiring an image that
contains the measurement. The system displays one measurement at a time.
Transducer Types
Available transducer types are curved array and linear array transducers. Applications for
specific transducers are listed in .“Clinical Applications and Transducers” on page 99
Indications for Use and Supporting Transducers
CAUTION
United States federal law restricts this device to sale by or on the order of a physician.
System Capabilities System Overview
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Ultrasound exams should be performed only for medical purposes with a prescription from a
licensed physician.
Use only transducers that are approved by Philips for use with your Philips ultrasound system.
The following are the indications for use for this system and the transducers supporting each
indication.
System Indications for Use and Supporting Transducers
Indication for Use Transducer
Abdominal C5-2, L12-4
Carotid L12-4
Cardiac Other (Fetal) C5-2
Fetal/Obstetric C5-2
Gynecological C5-2
Musculoskeletal L12-4
Small Parts L12-4
Urology C5-2
Peripheral Vessel L12-4
Patient Data Protection
The Lumify app does not encrypt patient data. It is your responsibility to configure your device
to meet your local security policies and regulatory requirements. Consult your healthcare-IT
security department to ensure that your device is configured in accordance with your specific
requirements for information security.
Philips recommends that you protect patient data by encrypting your device and setting a
password or passcode as a screen lock for your device, in accordance with your institution's
security policies and requirements. For instructions, see the documentation that accompanies
your device.
System Overview System Components
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When you are finished using the system, you can briefly press the On/Off control on the device
to lock the screen and prevent unauthorized access to patient data, or you can simply shut
down the system, which logs you off automatically. For more information about patient data
protection, see on your CD.Shared Roles for System and Data Security User Information
The Lumify Ultrasound System is not intended for long-term storage of patient data. Export
exams frequently and delete them after they are exported. You can also delete all patient data
from the Lumify system. For more information, see and“Exporting Exams” on page 92
“Deleting Patient Data and Lumify Settings” on page 78.
Wireless Networking
For information about configuring your device for wireless networking, see the documentation
that accompanies your device.
It is your responsibility to configure the wireless network security mechanisms that are
compatible with your network. Consult your healthcare IT security department to ensure that
your device is configured in accordance with your specific requirements for information
security.
System Components
The system consists of the following:
• The Philips Lumify app, available for download from the Google Play Store
• One or more Lumify Philips transducers, available with your Lumify subscription
• A compatible Android device (for a list of compatible devices, visit the Lumify portal:
www.philips.com/lumify)
• A carrying bag
• User information (see )“User Information Components” on page 12
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System Components
1 Android device
2 Transducer
Data Storage
You can export exams and images to a DICOM PACS, to a network share, or to a local
repository. You can also e-mail images. Supported e-mail applications include Gmail, K-9 Mail,
Yahoo, Outlook, and Inbox. For more information, see , “Exporting Exams” on page 92 “E-
mailing Exams” on page 93 “E-mailing Images” on page 91 and .
System Settings
To configure the settings for your system, touch and then select .Settings
System Overview System Settings
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Downloading and Installing the Lumify App Using the System
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Using the System
The topics that follow will help you understand and use the features of the system.
Downloading and Installing the Lumify App
The Lumify app is available from the Google Play Store. The Google Play Store (https://
play.google.com) is a digital media store, operated by Google, from which you can download
apps for the Android operating system. Before you install the Lumify app, make sure that your
device meets or exceeds the minimum specifications (see )“System Requirements” on page 63
and visit the Lumify portal for a list of compatible devices:
www.philips.com/lumify
1. On your Lumify-compatible Android device, open the Google Play Store.
2. Search for Lumify. If you cannot find Lumify, your device may not meet the minimum
specifications. For more information, see .“System Requirements” on page 63
3. Follow the displayed instructions to download and install the Lumify app.
Registration and Entitlement
Before you can use the Lumify app, you must register one or more transducers. The Lumify app
prompts you to register when you first connect the transducer to your device.
At least once a month, make sure that your device is connected to a wireless or cellular
network, with the Lumify app open and your transducers connected, so that the system can
automatically reregister your transducers.
NOTE
If you upgrade the Lumify app or the Android operating system, the system prompts you to
reregister the next time you connect a transducer.
4
Using the System Registering Your Transducers
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Registering Your Transducers
1. Make sure that your device is connected to a wireless or cellular network.
2. Start the Lumify App.
3. Connect your Philips transducer to your device. The first time you connect the transducer
to your device, the device prompts you to Open Lumify When This USB Device is
Connected. Select Use By Default For This USB Device, and then touch OK. The Lumify app
performs a system check and registers your transducer.
4. On the display, touch to begin using the system.Registration Complete Accept
If registration fails, see , or visit the Lumify portal for FAQs and“Troubleshooting” on page 135
troubleshooting tips:
www.philips.com/lumify
Updating the Lumify App
You can configure your device to update apps individually or allow them to be updated
automatically.
If your Lumify-compatible device is configured to automatically update apps, the Lumify app
updates automatically when an update is available, unless the update includes a permissions
change. In that case, you are prompted to update the Lumify app.
If your device is configured to update apps individually, you can obtain the latest Lumify update
from the Google Play Store. For more information, search for "update apps" in Google Play Help
Viewing the App Walkthrough
The first time you start the Lumify app, it displays a walkthrough tutorial to familiarize you with
the features of the system. To begin an exam after the walkthrough ends, touch Start Scanning.
You can view the walkthrough at any time.
Canceling Your Subscription Using the System
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Touch , and then touch Walkthrough .
Canceling Your Subscription
To cancel your subscription, visit the Lumify portal:
www.philips.com/lumify
Turning the System On and Off
WARNING
Failing to end the current exam before starting a new exam can result in data being acquired
and stored under the wrong patient name. If you close the Lumify app without ending the
exam, the system pauses the exam.
NOTE
If battery power is unavailable, or if the battery charge level is critically low, disconnect the
transducer and charge your device.
NOTE
Philips recommends that your device be fully charged before you start imaging. To avoid
unexpected battery discharging, charge your device at regular intervals, or when the device
displays the low-battery warning.
Before you turn on your device, disconnect the transducer and all peripheral devices.
Imaging Display Using the System
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Imaging Display (Landscape Orientation)
A Controls area
B Image area
C Patient information
1 Scan plane orientation marker
2 MI and TI values
3 Focal indicator
4 Page indicator: Touch the indicator to go to the next page of controls, or swipe to move between pages.
5 Image information
6 Review and settings menu
Using the System Imaging Display
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Imaging Display (Portrait Orientation)
A Controls area
B Image area
C Patient information
Quick Exams Using the System
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1 Scan plane orientation marker
2 MI and TI values
3 Focal indicator
4 Page indicator: Touch the indicator to go to the next page of controls, or swipe to move between pages.
5 Image information
6 Review and settings menu
Quick Exams
In an emergency, you can start an exam without entering patient data. This is called a quick
exam. During a quick exam, the system provides a medical record number (MRN) and the words
Quick ID appear as the patient's last name.
You can edit patient data until you end the exam.
Starting Quick Exams
CAUTION
You cannot edit patient information after you end the exam. After you end the exam, you
can only view patient information. You cannot edit data for previous exams.
1. On the display, select an exam preset .Scan/Create Patient
2. Touch . You can now begin imaging if you do not want to add any patient information.Scan
3. To add patient information:
a. On the imaging display, touch Quick ID.
b. On the display, type the patient information.Patient Info
Starting New Exams Performing an Exam
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Performing an Exam
This section guides you through procedures commonly used in performing patient exams with
the system. These procedures include entering patient data, acquiring and reviewing images,
and making measurements.
Have a backup system present during critical exams to ensure completion of the exam in the
event that the primary system fails.
NOTE
You are responsible for configuring your device in accordance with your institution's security
policies. Notifications and alerts from third-party applications may interfere with an exam.
Starting New Exams
1. On the display, select an exam preset.Scan/Create Patient
2. Do one of the following:
– To create a temporary Quick ID and start scanning immediately, touch . TheScan
imaging display appears, and you can begin scanning. For more information, see
“Starting Quick Exams” on page 77.
– To enter patient information before you begin scanning, touch . The lastCreate Patient
name is required. If you do not enter a medical record number (MRN), the system
creates an MRN for the exam. If the system finds a matching MRN in the patient
database, the system completes the remaining fields. To begin scanning,Patient Info
touch Start Exam.
Changing Presets During Exams
You can change presets during an active exam.
5
Performing an Exam Editing Patient Data
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1. Touch .
2. Under , touch a preset.Current Exam
Editing Patient Data
CAUTION
You cannot edit patient information after you end the exam. After you end the exam, you
can only view patient information. You cannot edit data for previous exams.
1. Touch and select Edit Patient Info.
2. Touch the field you want to edit and use the keyboard to replace, insert, or delete text.
3. Touch Save and Return.
Reviewing Saved Exams
You can review saved exams.
1. Touch .
2. Select Saved Exams .
3. Select an exam from the list. The exam opens in Review.
4. In the display, do any of the following:Review
• To make a measurement on an image from a saved exam, see “Performing a 2D
Distance Measurement” on page 83.
• To delete images from a saved exam, see .“Deleting Images and Loops” on page 92
Restarting a Paused Exam Performing an Exam
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• To e-mail images from a saved exam, see .“E-mailing Images” on page 91
• To export the exam, see .“Exporting Exams” on page 92
5. To exit the display and return to the current exam, touch and select Review Current
Exam .
NOTE
You cannot add new measurements to an exam that started more than 24 hours earlier.
Restarting a Paused Exam
If you leave an exam or close the system, you can return to the open exam within 24 hours by
touching and selecting Current Exam .
Imaging Modes
Available imaging modes are 2D and Color.
2D Mode
2D mode is the most commonly used imaging mode. In 2D mode, the image is displayed in
grayscale.
Using 2D Mode
1. Start an exam. The system enters 2D mode.
2. Optimize the image, using the controls in the controls area. If necessary, touch the page
indicator ( or ) or swipe to move between controls pages.
Performing an Exam Imaging Modes
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• To control the image gain, adjust the dial.Gain
• To increase or decrease the distance from the face of the transducer to the deepest
point in the displayed image, use the Depth dial.
• To increase or decrease the power output, use the dial.Power
• To view part of the image in more detail, spread your thumb and finger to zoom in on
that area of the image. For more information, see .“Zoom Magnification” on page 83
Color Mode
In Color mode, a color box is overlaid on the 2D image; its size and position can be adjusted
within the 2D image. The velocity and direction of flow in the color box are represented with
different colors for direction and different shades for velocity. The colors being used appear in
the color bar in the upper right corner of the imaging display.
Two color modes are available: (high color scale for arterial flow) and (lowFast Flow Slow Flow
color scale for venous flow).
Using Color Mode
1. In 2D mode, optimize the image.
2. If necessary, touch the page indicator ( or ) or swipe to display orFast Flow
Slow Flow .
3. Touch or Fast Flow Slow Flow .
4. To position the color box on the anatomy of interest, drag the color box. (If you drag
outside the color box, you pan the image.)
5. To change the size of the color box, pinch or spread inside the color box. (If you pinch or
spread outside the color box, you zoom the image.)
Imaging Features Performing an Exam
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6. To control the color gain, adjust the dial.Gain
7. To exit Color imaging, touch or Fast Flow Slow Flow .
Imaging Features
The system offers imaging features that provide improved imaging and greater flexibility when
you are imaging a patient.
AutoSCAN
AutoSCAN automatically and continuously optimizes 2D image brightness at the default gain.
AutoSCAN is always on.
Zoom Magnification
Using zoom magnification, you can magnify a region of interest in an image for closer
examination.
With your thumb and finger, spread to expand or pinch to reduce the specific area of the
image. Touch the image and move your finger to pan or move the magnified image.
NOTE
If you spread or pinch inside a color box, you resize the color box instead of zooming.
Performing a 2D Distance Measurement
A 2D distance measurement uses two calipers to measure the length of a straight line between
the two points.
Performing an Exam Measurement Accuracy
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You cannot zoom an image while you are using the 2D distance measurement tool. The system
removes measurements from the image when it is unfrozen or when the exam ends. To retain
the measurement on an image, acquire it (see ).“Acquiring Images” on page 85
1. Obtain the 2D image you want to measure and touch .
2. Touch . The word and an initial value appear at the top of theMeasure Distance
image.
3. Touch the first caliper and drag to position it.
4. Touch the second caliper and drag to position it. The results update as the distance
between the calipers changes.
5. To save an image with the distance shown, touch Save Image .
6. To remove the measurement, touch Measure .
Measurement Accuracy
You can use the ultrasound system to make measurements on ultrasound images. The
measurements are then used with other clinical data to make a diagnosis.
Making a diagnosis based solely on measurements is not recommended. There are numerous
factors to consider when using quantified data from any ultrasound imaging system. A careful
analysis of those factors indicates that the accuracy of each measurement is highly dependent
on image quality. Image quality in turn is highly dependent on system design, operator scanning
technique, familiarity with system controls and, most important, patient echogenicity.
Performing an Exam Acquiring Loops
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5. To save the image to the patient exam, touch . The system beeps whenSave Image
the image acquisition is complete.
Acquiring Loops
You can acquire and save a loop from the current exam. The acquired loop is saved in the
patient exam, and a thumbnail of it is available in the display. Loops in Review have theReview
icon in the lower right corner of the thumbnail.
The system captures loops prospectively. You can specify the loop length duration in Settings.
For more information, see .“System Settings” on page 67
To acquire a loop during live imaging, touch Save Loop .
The system beeps and a confirmation statement appears on the imaging display when the loop
has been saved.
Annotation
You can place text labels on an image to identify anatomical structures and locations. The
annotation feature is available in 2D and Color live and frozen modes.
Adding Labels
1. If necessary, touch the page indicator ( or ) or swipe to display Annotate .
2. Touch Annotate .
3. Use the on-screen keyboard to type a label. Auto-words appear to the left and right of the
letters you are typing. You can touch an auto-word to add it to your label.
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4. Drag the label into position in the imaging area.
5. To edit a label:
a. Touch the label. A line and the keyboard appear beneath it.
b. Touch a starting point in the label and begin typing, or use the Backspace key to erase
letters.
c. Touch anywhere in the imaging area to exit annotation.
6. To delete a label, touch and hold the label. Touch when it appears.Delete Annotation
Ending an Exam
WARNING
Failing to end the current exam before starting a new exam can result in data being acquired
and stored under the wrong patient name. If you turn off the system without ending the
exam, the system pauses the exam before shutting down.
Each time you finish an exam, you must end the exam to save images and other exam data. You
cannot end an exam while in Review.
You will not be able to end the exam until the system has saved exam data for the current
exam. (The system saves exam data when you acquire an image.) Ending an exam stores all
exam data, clears the form, and prepares for the next exam.Patient Info
The system automatically ends an exam if it has been open for longer than 24 hours. You
cannot append images to an ended exam.
When the exam is complete, touch at the top of the imaging display.End Exam
E-mailing Images Review
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E-mailing Images
WARNING
It is your responsibility to ensure the security of your device and of patient data to meet
your local security policies and regulatory requirements. Before e-mailing images or exams,
consult your healthcare IT security department to ensure that you are in compliance with
your department's specific policies and regulations regarding the handling of patient
information. For more information, see Shared Roles for System and Data Security on your
User Information CD.
You must end the exam before you can export or e-mail images or the exam itself.
The system e-mails still images in PNG format and loops in MP4 format.
You may need to set up an e-mail client on the device before you can e-mail images. For setup
instructions, see the following website and search for "configure email client":
https://support.google.com
If several e-mail accounts are available on the device, the system prompts you to select from a
list of the available accounts. Possible e-mail accounts include:
• Inbox
• Gmail
• K-9 Mail
• Outlook
• Yahoo
1. In the display, touch and hold a thumbnail image. A check mark with appearsReview Done
in the upper left corner of the imaging display. Touch additional images to add them to the
e-mail.
2. Touch Email .
Review Deleting Images and Loops
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3. Touch to accept the content of the privacy notice. The device's default e-mailContinue
account opens and displays a new message with the images attached.
4. Add recipients and text to the e-mail and send the e-mail. The image is automatically
attached to the e-mail.
Deleting Images and Loops
1. In the display, touch and hold a thumbnail image. A check mark with appearsReview Done
in the upper left corner of the imaging display. Touch additional images to delete more
than one image.
2. Touch Delete .
3. Touch to confirm the deletion.Yes
Exporting Exams
You can export exams to a DICOM PACS, to a network share, or to a local repository. See
“Configuring Export Destinations” on page 95.
You must end the exam before you can export or e-mail images or the exam itself.
The system exports still images in PNG format and loops in MP4 format.
NOTE
The Lumify ultrasound system does not retain patient information in images exported to a
DICOM PACS.
1. Touch and select Saved Exams .
2. Do one of the following:
E-mailing Exams Review
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• To export a single exam, touch it to open it in and then touch Review Export Exam .
• To export one or more exams, touch and hold an exam until appears.Selected Exams
Touch additional exams to select them. Touch Export .
3. Select a destination from the menu. (To add a new destination, select Export Exam Add
New. For more information, see .)“Configuring Export Destinations” on page 95
A confirmation message appears when the export is complete.
E-mailing Exams
WARNING
It is your responsibility to ensure the security of your device and of patient data to meet
your local security policies and regulatory requirements. Before e-mailing images or exams,
consult your healthcare IT security department to ensure that you are in compliance with
your department's specific policies and regulations regarding the handling of patient
information. For more information, see Shared Roles for System and Data Security on your
User Information CD.
You must end the exam before you can export or e-mail images or the exam itself.
You may need to set up an e-mail client on the device before you can e-mail exams. For setup
instructions, see the following website and search for "configure email client":
https://support.google.com
If several e-mail accounts are available on the device, the system prompts you to select from a
list of the available accounts. Possible e-mail accounts include:
• Inbox
• Gmail
Review Deleting Exams
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• K-9 Mail
• Outlook
• Yahoo
1. Touch and select Saved Exams .
2. Select an exam and touch Export Exam .
3. On the menu, select Export Exam Email.
4. Touch to accept the content of the privacy notice. The device's default e-mailContinue
account opens displaying a new message with the exam attached.
5. Add recipients and text to the e-mail and send the e-mail. The exam images and
information are automatically attached to the e-mail.
Deleting Exams
After you have exported exams, you can delete them to save space on the system.
1. Touch and select Saved Exams .
2. Touch and hold an exam until appears.Selected Exams
3. Do one of the following:
• To delete the selected exam, touch Delete .
• To delete multiple exams, touch to select additional exams and then touch Delete .
• To delete all exams, touch and then touch Select All Delete .
4. In the box, touch Delete Confirmation Yes.
Review Export Destination Settings
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Setting Description
Advanced Options,
Advanced
Connection Settings
•DNS Suffix
•Read Timeout (Sec): The network reply timeout
• : The DICOM ARTIM timeoutConnection Timeout (sec)
• : How much time the system will wait before retrying a job to theRetry Interval (sec)
server
• : How many retries the system will perform before failing the jobMaximum Retries
Network Share Destination Settings
Setting Description
Hostname The IP or computer name of the server hosting the network share
User The domain and user name for the network share
Password The password for the network share
Remote Directory The path to the network share
Exported Filename
Syntax
The order in which you select file name fields reflects the order that the field appears in the
folder name for the exported content and is reflected in . For example,Example Export Path
if you select and then , the folder name will begin with the name, followed byLast MRN Last
the MRN.
Advanced Options,
Image Resolution
Choose a resolution that matches the display on which the exam will be viewed
Advanced Options,
Display
Compensation
Brightness and Contrast
Advanced Options,
Advanced
Connection Settings
•DNS Suffix
•Retry Interval (sec) : How much time the system will wait before retrying a job to the
server
• : How many retries the system will perform before failing the jobMaximum Retries
Clinical Applications and Transducers Transducers
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Transducers
The transducer is the most important factor in image quality. Optimal imaging cannot be
obtained without the correct transducer. The system is optimized for use based on your
transducer selection.
The system limits patient contact temperature to 43°C (109°F), and acoustic output values to
their respective U.S. Food and Drug Administration limits. A power-protection circuit protects
against over-current conditions. If the power monitor protection circuit senses an over-current
condition, then the drive voltage to the transducer is shut off immediately, preventing
overheating of the transducer surface and limiting acoustic output. Validation of the power
protection circuit is done under normal system operation.
WARNING
To limit potential harm when scanning neonatal, pediatric, and medicated patients,
minimize the time spent imaging at temperatures above 41°C (106°F).
Clinical Applications and Transducers
A clinical application, available for one or more transducers, optimizes the system for a specific
application. A clinical application consists of a preset for the transducer.
The clinical applications for the transducers that are compatible with your ultrasound system
are listed here.
System Transducers and Supported Clinical Applications
Transducer Clinical Applications
C5-2 Abdomen, GYN, OB, Fetal Echo, Urology
L12-4 Abdomen, Musculoskeletal, Small Parts, Vascular
7
Transducers Transducer Maintenance
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Transducer Maintenance
Transducers require proper care, cleaning, and handling. Reasonable care includes inspection,
cleaning, and disinfection or sterilization, as necessary.
Inspect the transducer, cable, and lens before each use. Check for cracks or other damage that
jeopardizes the integrity of the transducer. Report any transducer damage to your Philips
representative, and discontinue use of the transducer.
For all information on transducer cleaning and disinfection, see the section.“Transducer Care”
For all information about the use of acoustic coupling gels, see “Ultrasound Transmission Gels”
on page 104.
If you encounter poor image quality or transducer problems, see “Troubleshooting” on page
135.
CAUTION
Some ultrasound coupling gels, as well as some solutions for pre-cleaning, disinfecting, and
sterilizing can damage a transducer. Before using a gel or solution on a transducer, see
“Ultrasound Transmission Gels” on page 104 or the “Transducer Care” section. You can also
contact your local Philips representative. For contact information, see “Customer Service”
on page 17.
Acoustic Artifacts
The transducer adds its own signature to the echo information in the form of beam width
effects, axial resolution limitations, and frequency characteristics. The control choices made by
the sonographer that affect amplification, signal processing, and echo signal display can lead to
significant differences in the displayed appearance of echo data. Following is a brief discussion
of acoustic artifacts. An understanding of the physical basis for the production of signals
displayed on ultrasound images is helpful in minimizing artifacts on images and interpreting the
results of studies.
Transducers Acoustic Artifacts
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Mirroring is the appearance of artifacts on a spectral display when there is improper separation
of forward and reverse signal processing channels. Consequently, strong signals from one
channel mirror into the other.
Multi-path positioning and refraction artifacts describe the situation in which the paths to and
from a reflector are different. The longer the sound takes traveling to or from a reflector, the
greater the axial error in reflector positioning (increased range). Refraction and multi-path
positioning errors are normally relatively small and contribute to general degradation of the
image rather than to gross errors in object location.
Propagation speed errors occur when the assumed value for propagation speed by the
ultrasound system is incorrect. If the actual speed is greater than that assumed, the calculated
distance to a reflector is too small, and the reflector will be displayed too far from the
transducer. Speed error can cause a structure to be displayed with incorrect size and shape.
Range ambiguity can occur when reflections are received after the next pulse is transmitted. In
ultrasound imaging, it is assumed that for each pulse produced, all reflections are received
before the next pulse is sent out. The ultrasound system calculates the distance to a reflector
from the echo arrival time assuming that all echoes were generated by the last emitted pulse.
The maximum depth to be imaged unambiguously by the system determines its maximum
pulse repetition frequency.
Reverberation is the continuing reception of a particular signal because of reverberation rather
than reflection from a particular acoustic interface. This phenomenon is analogous to the effect
created by mirrors positioned on opposite walls when an object, a head for instance, is placed
between the mirrors. The image of the head is reflected back and forth infinitely between the
two mirrors, creating the optical illusion of multiple heads. Reverberations are easily
identifiable, because they are equally spaced on the display.
Scattering is the diffuse, low-amplitude sound waves that occur when acoustic energy reflects
off tissue interfaces smaller than a wavelength. In diagnostic ultrasound, Doppler signals come
primarily from acoustic energy back-scattered from red blood cells.
Shadowing is the reduction in echo amplitude from reflectors that lie behind a strongly
reflecting or attenuating structure. This phenomenon occurs when scanning a lesion or
structure with an attenuation rate higher than that of the surrounding tissue. The lesion causes
Transducer Covers Transducers
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a decrease in beam intensity, which results in decreased echo signals from the structures
beyond the lesion. Consequently, a dark cloud behind the lesion image forms on the display.
This cloud, or shadow, is useful as a diagnostic clue.
Side lobes (from single-element transducers) and grating lobes (from array transducers) cause
objects that are not directly in front of the transducer to be displayed incorrectly in lateral
position.
Speckle appears as tissue texture close to the transducer but does not correspond to scatterers
in tissue. It is produced by ultrasound wave interference and results in general image
degradation.
Spectral broadening is a display phenomenon that occurs when the number of energy-bearing
Fourier frequency components increases at any given point in time. As a consequence, the
spectral display is broadened. Spectral broadening can indicate the disturbed flow caused by a
lesion, and therefore it is important diagnostically. However, broadening can also result from
interaction between flow and sample volume size, in which case it is an artifact.
Speed of sound artifacts occur if the sound propagation path to a reflector is partially through
bone, and the speed of sound is greater than in the average soft tissue. Echo position
registration artifacts will be produced. Reflectors appear closer to the transducer than their
actual distance because of this greater speed of sound, resulting in a shorter echo transit time
than for paths not containing bone.
Transducer Covers
For procedures for using transducer covers, see the instructions provided with the covers.
WARNING
Latex and talc are commonly used in sheaths marketed to help with infection control during
biopsies. Examine the packaging to confirm latex and talc content. Studies have shown that
patients can experience allergic reactions with natural rubber latex. See the FDA Medical
Alert, March 29, 1991, reprinted in “FDA Medical Alert on Latex” on page 33.
Transducer Storage Transducers
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CAUTION
Do not use hand sanitizing gels.
CAUTION
Do not apply the transducer gel until you are ready to perform the procedure. Transducers
should not be left soaking in gel.
CAUTION
Gels listed here are recommended because of their chemical compatibility with product
materials.
Some recommended gels include:
• Aquasonic 100
• Aquasonic Clear
• Carbogel-ULT
• ECG Gel (Nicom)
• Nemidon Gel
• Scan
Transducer Storage
Use the appropriate guidelines for storing transducers for transport, and daily and long-term
storage.
Transducers Testing Transducers
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Storage for Transport
Always use the carrying bag is provided with your transducer to transport the transducer from
one site to another. Follow these guidelines to properly store transducers for transport:
• Make sure that the transducer is clean and disinfected before placing it in the carrying bag
to avoid contaminating the bag
• Place the transducer in the bag carefully to prevent kinking of the cable.
Daily and Long-Term Storage
Follow these guidelines to protect your transducer:
• Avoid storing transducers in areas of temperature extremes or in direct sunlight.
• Store transducers separately from other instruments to avoid inadvertent transducer
damage.
• Before storing transducers, make sure they are thoroughly dry.
Testing Transducers
You can run transducer tests to diagnose image quality and transducer issues.
1. Make sure that your device is connected to a wireless or cellular network.
2. Connect the transducer to your device.
3. Make sure that the transducer lens is clean, dry, and not touching anything.
4. Touch and select Settings .
5. In , touch Transducer Tests Run Tests.
The system runs a series of tests and then sends the logs to Philips Remote Services. If your
device is not connected to a wireless or cellular network, the logs are queued until you have
network connectivity. For more information, contact your Philips representative or visit the
Lumify portal:
www.philips.com/lumify
Transducer Care and Operator Safety Transducer Care
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Transducer Care
All Philips transducers require proper care, cleaning, and handling. This section contains
information and instructions to help you effectively clean, disinfect, and sterilize the
transducers that are compatible with your Philips ultrasound system. Additionally, these
instructions help avoid damage during cleaning, disinfection, and sterilization, which could void
your warranty.
Reasonable care includes inspection, cleaning, and disinfection or sterilization, as necessary.
Transducers must be cleaned after each use. Inspect all parts of the transducer carefully before
each use. Check for cracks or other damage that jeopardizes the integrity of the transducer.
Report any damage to your Philips representative, and discontinue use of the transducer.
The Lumify system does not support transesophageal echocardiographic (TEE) transducers, so
the care and cleaning information provided is specific to non-TEE transducers.
For information on the gels that are compatible with your system's transducers, see
“Ultrasound Transmission Gels” on page 104.
Transducer Care and Operator Safety
Observe the following warnings and cautions during all cleaning, disinfection, and sterilization
procedures and when using disinfectants. More specific warnings and cautions are included
within the care and cleaning procedures and on the labels of the cleaning or disinfection
solutions.
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
8
Transducer Care Transducer Care and Operator Safety
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WARNING
Disinfectants are recommended because of their chemical compatibility with product
materials, not their biological effectiveness. For the biological effectiveness of a disinfectant,
see the guidelines and recommendations of the disinfectant manufacturer, the U.S. Food
and Drug Administration, and the U.S. Centers for Disease Control.
WARNING
If a pre-mixed solution is used, be sure to observe the solution expiration date.
WARNING
The level of disinfection required for a device is dictated by the type of tissue it will contact
during use. Ensure the disinfectant type is appropriate for the type of transducer and the
transducer application. For information on the levels of disinfection requirements, see
“Transducer Care Methods” on page 113. Also, see the disinfectant label instructions and
the recommendations of the Association for Professionals in Infection Control, the U.S. Food
and Drug Administration, and the U.S. Centers for Disease Control.
WARNING
Transducers must be cleaned after each use. Cleaning the transducer is an essential step
before effective disinfection or sterilization. Be sure to follow the manufacturer’s
instructions when using disinfectants.
WARNING
When sterilizing a transducer, ensure that the sterilant solution's strength and duration of
contact are appropriate for sterilization. Be sure to follow the manufacturer's instructions.
Transducer Care Transducer Care and Operator Safety
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CAUTION
Do not use paper products or products that are abrasive when cleaning the transducer. They
damage the soft lens of the acoustic window of the transducer.
CAUTION
During cleaning, disinfection, and sterilization, orient the USB connector and cable that must
remain dry higher than the wet parts, until all parts are dry. This helps keep liquid from
entering unsealed areas of the transducer.
CAUTION
When cleaning and disinfecting transducers, do not allow any fluid to enter electrical
connections or metal portions of the USB connector. Damage due to fluids in these areas is
not covered by the warranty or your service contract.
CAUTION
To keep fluids from entering the transducer, do not disconnect the USB cable from the
transducer during cleaning and disinfection.
CAUTION
When using an enzymatic cleaner, be sure to use the proper concentration and rinse
thoroughly.
Transducer Care and Operator Safety Transducer Care
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CAUTION
Before storing transducers, ensure that they are thoroughly dry. If it is necessary to dry the
transducer lens or acoustic window after cleaning, use a soft cloth and a blotting motion,
instead of a wiping motion.
CAUTION
The only parts of the transducer that may be cleaned with isopropyl alcohol are the
transducer housing and lens or acoustic window. Ensure that the solution is only 70%
alcohol or less. Do not wipe any other part of a transducer with isopropyl alcohol (including
cables, USB connectors, or strain reliefs), as it can damage those parts of the transducer.
This damage is not covered by the warranty or your service contract.
Alcohol-Compatible Transducer Parts
The only part that can be wiped with 70% isopropyl alcohol or other alcohol-based disinfectant is the transducer
housing and lens outlined above. Do not allow fluid to enter any unsealed area of the transducer.
Transducer Care Transducer and Cable Cleaning
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•“High-level Disinfecting of Transducers” on page 118
WARNING
Always use protective eyewear and gloves when cleaning and disinfecting any equipment.
CAUTION
When cleaning and disinfecting transducers, do not allow any fluid to enter electrical
connections or metal portions of the USB connector. Damage due to fluids in these areas is
not covered by the warranty or your service contract.
Parts of a USB Transducer Cable
Transducer Care Disinfectants Compatibility
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WARNING
Not all disinfectants are effective against all types of contamination. Ensure the disinfectant
type is appropriate for the type of transducer and that the solution strength and duration of
contact are appropriate for the intended clinical use.
WARNING
Disinfectants listed in this section are recommended because of their chemical compatibility
with product materials, not their biological effectiveness. For the biological effectiveness of
a disinfectant, see the guidelines and recommendations of the disinfectant manufacturer,
the Association for Professionals in Infection Control, the U.S. Food and Drug
Administration, and the U.S. Centers for Disease Control.
WARNING
If a pre-mixed solution is used, be sure to observe the solution expiration date.
WARNING
Always use protective eyewear and gloves when cleaning, disinfecting, and sterilizing any
equipment.
Transducer Care Disinfectants Compatibility
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• Sodium hypochlorite based (for example 10% household bleach solution with active sodium
hypochlorite at approximately 0.6%)
• Quaternary ammonium (QUAT) based (for example, products that contain n-alkyl (x)benzyl
ammonium chloride solution where (x) can be any organic functional group such as ethyl
and methyl, and so on; concentration at use should be less than 0.8% total for all QUATs
listed)
• Accelerated hydrogen peroxide based (0.5% hydrogen peroxide maximum)
• Alcohol or alcohol plus QUAT based (product alcohol content cannot exceed 70%)
• You may also use products not specifically listed in the compatibility table but with similar
active ingredients, as indicated in this list, and marketed for medical use
Always follow the manufacturer's instructions when using disinfectants and cleaning solutions.
Because of the large number of available cleaning and disinfection products, it is impossible to
have an all-inclusive list. If you are unsure of the suitability of a particular product, please
contact your Philips representative for more information:
• www.philips.com/transducercare
• In North America, call Philips at 800-722-9377.
• Outside North America, contact your local Philips representative.
Disinfectants Compatibility Transducer Care
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Disinfectants and Cleaning Solutions Compatibility Table Legend
Origin (Country
Code)
Qualified Use Type Compatibility
AU = Australia
CA = Canada
DE = Germany
ES = Spain
FR = France
JP = Japan
UK = United Kingdom
US = United States
CL = Cleaner
HLD = High-level
disinfectant
ILD = Intermediate-
level disinfectant
LLD = Low-level
disinfectant
S = Sterilant
C = Approved for use on the USB cable and connector (never
immerse or soak a connector)
N = Not approved for use
T = Approved for use on the transducer
Non-TEE Transducers (Micro-USB Connector)
1 C (Cable and connector)
2 T (Transducer)
Transducer Care Disinfectants Compatibility
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Disinfectants and Cleaning Solutions for Transducers
Solution Origin Qualified Use Active Ingredients Type C5-2
L12-4
70% Isopropyl Alcohol All Spray/Wipe Alcohol LLD, ILD T
AbcoCide US Soak1Glutaraldehyde HLD, S T
AbcoCide 28 US Soak1Glutaraldehyde HLD, S T
Accel Wipes (all types) CA Wipe Hydrogen Peroxide LLD, ILD T,C
Acecide JP Soak1Peracetic acid HLD N
Aidal Plus AU Soak1Glutaraldehyde HLD, S T
Alkaspray FR Spray/Wipe Alcohol, Alkylamine LLD, ILD T
Ampholysine Basique FR Spray/Wipe Biguanide/Quat. Ammonia LLD, ILD T,C
Aniosept Activ FR Soak1Peracetic acid HLD, S T
ANIOXY DM FR Soak1Peracetic acid HLD, S T
Anioxyde 1000 FR Soak1Peracetic acid HLD T
Antigermix E1 FR E1 System UV-C HLD N
Antigermix S1 FR S1 System UV-C HLD T,C
Banicide Plus US Soak1Glutaraldehyde HLD, S T
Bleach (0.6% NaOCl Max) All Spray/Wipe Sodium Hypochlorite LLD, ILD T,C
CaviWipes US Wipe Alcohol, Quat. Ammonia LLD, ILD T
Cidex US Soak1Glutaraldehyde HLD, S T
Cidex 7 US Soak1Glutaraldehyde HLD, S T
Cidex OPA US Soak1Ortho-phthalaldehyde HLD T
Cidex PAE 14J FR Soak1Glutaraldehyde HLD, S T
Disinfectants Compatibility Transducer Care
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Solution Origin Qualified Use Active Ingredients Type C5-2
L12-4
Cidex Plus US Soak1Glutaraldehyde HLD, S T
Cleanisept Wipes/forte DE Spray/Wipe Quat. Ammonia LLD, ILD T,C
Clorox Healthcare Bleach
Germicidal Cleaner
US Spray/Wipe Sodium Hypochlorite LLD, ILD T,C
Clorox Healthcare
Hydrogen Peroxide Cleaner
Disinfectants
US Spray/Wipe Hydrogen Peroxide LLD, ILD T,C
Combi-Instruments-N FR Soak1Glutaraldehyde and
formacetale blend
HLD T
Descoton Extra DE Soak1Glutaraldehyde HLD, S T
Dispatch US Spray/Wipe Sodium Hypochlorite LLD, ILD T,C
Endosporine FR Soak1Glutaraldehyde HLD, S T
Enzol US Pre-cleaner Enzymes CL T
Epizyme Rapid AU Pre-cleaner Enzymes CL T
Gigasept FF (neu) DE Soak1Succinic dialdehyde HLD T
Gigasept PA DE Soak1Peracetic acid HLD T
Gigasept PAA Concentrate DE Soak1Peracetic acid HLD T
Incidin DE Spray/Wipe Alcohol LLD, ILD T
Incidur Spray DE Spray/Wipe Alcohol, Quat, Aldehyde LLD, ILD T
Instruzyme FR Pre-cleaner Enzymes, Quat. Ammonia,
Biguanide
CL T
Klenzyme US Pre-cleaner Enzymes CL T
Korsolex Basic FR Soak1Aldehyde Releasing HLD T
Transducer Care Disinfectants Compatibility
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Solution Origin Qualified Use Active Ingredients Type C5-2
L12-4
Rapicide OPA US Soak1Ortho-phthalaldehyde HLD T
Rapicide PA US Soak1Peracetic acid HLD N
Revital-Ox Resert XL HLD US Soak1Hydrogen Peroxide HLD T
Rivascop FR Spray/Wipe Quat. Ammonia LLD, ILD T,C
Salvanios pH 10 FR Spray/Wipe Quat. Ammonia LLD, ILD T,C
Sani-Cloth Active DE Wipe Quat. Ammonia LLD, ILD T,C
Sani-Cloth AF US Wipe Quat. Ammonia LLD, ILD T,C
Sani-Cloth AF3 US Wipe Quat. Ammonia LLD, ILD T,C
Sani-Cloth HB US Wipe Quat. Ammonia LLD, ILD T,C
Sani-Cloth Bleach US Wipe Sodium Hypochlorite LLD, ILD T,C
Sani-Cloth Plus US Wipe Alcohol, Quat. Ammonia LLD, ILD T
Sekucid N FR Soak1Glutaraldehyde HLD, S T
Sekusept Aktiv DE Soak1Peracetic acid HLD T
Sekusept Easy DE Soak1Peracetic acid HLD T
Sekusept Plus DE Soak1Glucoprotamine HLD T
Soluscope P FR AER Peracetic acid HLD N
Steranios 2% FR Soak1Glutaraldehyde HLD, S T
Sterrad 100S US Reprocessor (S) Hydrogen Peroxide S N
TD-5 US TD-100
Reprocessor
Glutaraldehyde HLD, S N
Tristel Duo UK Foam /Wipe Chlorine Dioxide HLD T,C
Produktspecifikationer
| Varumärke: | Philips |
| Kategori: | Inte kategoriserad |
| Modell: | Lumify |
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