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Philips Lumify User Manual

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User Manual
English
  
Lumify Ultrasound System

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Table of Contents

   Summary of Contents for Philips Lumify

  • Page 1 User Manual English    Lumify Ultrasound System...
  • Page 3: Table Of Contents

    Electrical Safety............................... 24 Defibrillators............................27 Fire Safety............................28 Equipment Protection............................. 28 Product Compatibility............................. 30 Symbols................................30 Biological Safety.............................. 33 FDA Medical Alert on Latex....................... 35 ALARA Education Program........................ 37 Output Display........................... 41 Control Effects........................... 44 Related Guidance Documents......................46 Lumify Ultrasound System...
  • Page 4 Device Requirements............................67 System Capabilities............................68 Measurements........................... 68 Transducer Types..........................68 Indications for Use and Supporting Transducers................69 Patient Data Protection........................70 Wireless Networking......................... 70 System Components............................71 Data Storage ............................. 72 System Settings............................... 72 System Information............................73 Lumify Ultrasound System...
  • Page 5 Using the System............................ 75 Downloading and Installing the Lumify App....................75 Registration and Entitlement.......................... 75 Registering Your Transducers......................... 76 Giving Lumify Access to Shared Device Storage..................... 76 Updating the Lumify App..........................77 Viewing the App Walkthrough........................77 Canceling Your Subscription........................... 77 Turning the System On and Off........................
  • Page 6 Ending an Exam............................. 100 Review..............................103 Starting Review During an Exam........................103 Starting Review After an Exam........................103 Navigating Thumbnails and Images......................103 Playing Loops..............................104 E-mailing Images............................105 Deleting Images and Loops........................... 106 Exporting Exams............................106 Lumify Ultrasound System...
  • Page 7 Daily and Long-Term Storage......................123 Testing Transducers............................123 Transducer Care............................ 125 Transducer Care and Operator Safety......................125 Latex Product Alert.......................... 130 Transducer Care Methods..........................131 Transducer and Cable Cleaning........................132 Cleaning a Transducer........................133 Low-level Disinfecting of Transducers......................135 Lumify Ultrasound System...
  • Page 8 System Maintenance..........................151 Device Maintenance............................. 151 Transducer Maintenance ..........................152 Sending System Logs............................. 153 Viewing Audit Logs............................153 Troubleshooting............................153 Error Messages............................. 154 For Assistance............................... 155 10 Specifications............................157 System Specifications........................... 157 Safety and Regulatory Requirements......................158 Index..............................159 Lumify Ultrasound System...
  • Page 9: Read This First

    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.
  • Page 10: Intended Audience

    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, air, and emergency vehicles.
  • Page 11: Warnings

    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.
  • Page 12: Warning Symbols

    • Acoustic Output Tables: Included on the CD, it contains information about acoustic output and patient-applied part temperatures. • Medical Ultrasound Safety: Included on the CD, it contains information on bioeffects and biophysics, prudent use, and implementing ALARA (as low as reasonably achievable). Lumify Ultrasound System...
  • Page 13: User Information Conventions

    • Shared Roles for System and Data Security: Included on the CD, it contains guidelines to help you understand security recommendations for your Philips product and information on Philips' efforts to help you prevent security breaches. Some user information is also available on the Support section of the Lumify portal: www.philips.com/lumify User Information Conventions...
  • Page 14 Double tap Touch the screen briefly twice with the same finger. Pinch Touch the screen with two fingers and move them toward each other. Touch Touch a control with your finger. Lumify Ultrasound System...
  • Page 15 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. Lumify Ultrasound System...
  • Page 16: Upgrades And Updates

    For more information, see “Updating the Lumify App” on page Supplies and Accessories To order supplies and accessories, visit the Lumify portal (www.philips.com/lumify), or contact CIVCO Medical Solutions: CIVCO Medical Solutions 102 First Street South, Kalona, IA 52247‑9589 Telephone: 800‑445‑6741 (USA and Canada), +1 319‑248‑6757 (International)
  • Page 17: 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...
  • Page 18 Final Disposal of Your Device At the end of your Lumify subscription, you must return your transducer or transducers to Philips. Do not dispose of the transducers. For more information, see the Support section of the Lumify portal: www.philips.com/lumify...
  • Page 19 Misuse or abuse could cause physical injury. WARNING If electrolyte leakage occurs, wash your skin with large amounts of water, to prevent skin irritation and inflammation. Lumify Ultrasound System...
  • Page 20 Read This First Recycling, Reuse, and Disposal Lumify Ultrasound System...
  • Page 21: Safety

    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.
  • Page 22 Use the system only for its intended purposes and do not misuse the system. 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.
  • Page 23 Safety 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.
  • Page 24: Electrical Safety

    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 Lumify Ultrasound System...
  • Page 25 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.
  • Page 26 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. Lumify Ultrasound System...
  • Page 27: Defibrillators

    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. Lumify Ultrasound System...
  • Page 28: Fire Safety

    Fire regulations for the type of medical area being used should be fully applied, observed, and enforced. Fire extinguishers should be available for both electrical and nonelectrical fires. Equipment Protection Follow these precautions to protect your system: Lumify Ultrasound System...
  • Page 29 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...
  • Page 30: Product Compatibility

    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.
  • Page 31 The backlight lamps in an LCD system monitor contain mercury. Do not throw away. Dispose of in accordance with local, state, or federal laws. Global Medical Device Nomenclature Code Lumify Ultrasound System...
  • Page 32 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. Lumify Ultrasound System...
  • Page 33: Biological Safety

    For more information, see Medical Ultrasound Safety on your User Information CD. 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. Lumify Ultrasound System...
  • Page 34 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 WARNING Transducer covers may contain natural rubber latex. Those covers may cause allergic reactions in some individuals.
  • Page 35: Fda Medical Alert On Latex

    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.
  • Page 36 (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. Lumify Ultrasound System...
  • Page 37: Alara Education Program

    NOTE The transducers described in this document do not contain natural rubber latex that contacts humans. Natural rubber latex is not used on any Philips ultrasound transducer. ALARA Education Program The guiding principle for the use of diagnostic ultrasound is defined by the "as low as reasonably achievable"...
  • Page 38 Application selection and the output-power control directly affect acoustic intensity. There are different ranges of allowable intensity or output based on your selection. Selecting the correct range of acoustic intensity for the application is one of the first things that occurs in any exam. Lumify Ultrasound System...
  • Page 39 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. Lumify Ultrasound System...
  • Page 40 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. Lumify Ultrasound System...
  • Page 41: Output Display

    • 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. Lumify Ultrasound System...
  • Page 42 You can choose to display TIS, TIC, or TIB. For details on changing the TI display, see “Setting the Thermal Index Display” on page Mechanical and Thermal Indices Display Precision and Accuracy The MI and TI precision is 0.1 unit on the system. Lumify Ultrasound System...
  • Page 43 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. Lumify Ultrasound System...
  • Page 44: Control Effects

    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. Lumify Ultrasound System...
  • Page 45 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. Lumify Ultrasound System...
  • Page 46: Related Guidance Documents

    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 Lumify Ultrasound System...
  • Page 47 In Situ, has been estimated by using the following formula: In Situ = Water [e -0.23alf Where: Variable Value In Situ In Situ intensity value Water Water value intensity 2.7183 Attenuation factor Tissue a(dB/cm-MHz) Amniotic Fluid 0.006 Brain 0.53 Heart 0.66 Lumify Ultrasound System...
  • Page 48 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 Lumify Ultrasound System...
  • Page 49 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/cm . The Lumify Ultrasound System...
  • Page 50: Acoustic Output Tables

    (MPa). Wo is the ultrasonic power in milliwatts (mW). 6.2% is the center frequency in megahertz (MHz) <1% (NEMA UD-2 definition). PII.3 is the derated spatial-peak pulse intensity PII.3: 3.2% integral in joules per square centimeter (J/cm Lumify Ultrasound System...
  • Page 51: Operator Safety

    • Maintain your joints in optimum positions with a balanced posture while scanning. • Allow frequent breaks to give soft tissue a chance to recuperate from awkward positions and repetitive movement. • Avoid gripping the transducer with excessive force. Lumify Ultrasound System...
  • Page 52: Philips Transducers

    Medical Sonographer." Journal of Diagnostic Medical Sonographers, 266-227, November/ December 1996. Philips Transducers Use only transducers that are approved by Philips for use with your Philips ultrasound system. “Clinical Applications and Transducers” on page 116 for a list of the transducers that are compatible with your ultrasound system.
  • Page 53: Electromagnetic Compatibility

    Disposable Drape If you believe contamination of the system might occur during an exam, Philips recommends that you take universal precautions and cover the system with a disposable drape. Consult your facility's rules regarding equipment use in the presence of infectious disease.
  • Page 54 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. Lumify Ultrasound System...
  • Page 55: Electrostatic Discharge Precautions

    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. Lumify Ultrasound System...
  • Page 56: Approved Cables For Electromagnetic Compliance

    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. Approved Cables Cable Length Philips Part Number Transducer Cable Kit (C5-2 , L12-4) 1.25 m (4 ft) 453561806941 Lumify Ultrasound System...
  • Page 57: Approved Transducers For Electromagnetic Compliance

    CISPR 22, Class A- or B-compliant devices, unless otherwise noted. 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. Lumify Ultrasound System...
  • Page 58: Electromagnetic Immunity

    NOTE The guidelines specified here may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. NOTE is the AC power voltage before application of the test level. Lumify Ultrasound System...
  • Page 59 AC be that of a typical power commercial or hospital environment. Surge, IEC 61000-4-5 Not applicable. The device Mains power quality should does not function on AC be that of a typical power commercial or hospital environment. Lumify Ultrasound System...
  • Page 60 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 Lumify Ultrasound System...
  • Page 61: Electromagnetic Interference

    Electromagnetic Compatibility Safety 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.
  • Page 62: Recommended Separation Distance

    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 Lumify Ultrasound System...
  • Page 63 Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. The information provided here, in conjunction with “Electromagnetic Interference” on page provides guidance on conducted and radiated interference from portable and fixed RF transmitting equipment. Lumify Ultrasound System...
  • Page 64: 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.
  • Page 65: Use Restrictions Due To 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.
  • Page 66 Safety Electromagnetic Compatibility Lumify Ultrasound System...
  • Page 67: System Overview

    Lumify portal: www.philips.com/Lumify-Compatible-Devices Although Philips cannot guarantee that the Lumify app will work on a device that is not on the list of compatible devices, these are the minimum device specifications. Your device must meet all of the following specifications: •...
  • Page 68: System Capabilities

    • NVIDIA Tegra 3 Quad-Core CPU, 1.2 GHz (minimum) • Wireless or cellular networking capability • Access to ports 80 and 443 Philips verifies that the devices on the Compatible Tablets list on the Lumify portal (www.philips.com/Lumify-Compatible-Devices) comply with the USB On-The-Go standard. System Capabilities...
  • Page 69: Indications For Use And Supporting Transducers

    Lumify is a prescription ultrasound device intended for use by licensed healthcare professionals. 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.
  • Page 70: Patient Data Protection

    System Capabilities 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.
  • Page 71: System Components

    • 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-Compatible-Devices) •...
  • Page 72: Data Storage

    Allows you to repair or reset the patient database. To remove corruption in the system, touch Repair Database. To delete all patient data and reset the database, touch Reset Database. For more information, see “Deleting Patient Data and Lumify Settings” on page Power Control Displays a control that you can use to adjust the output power.
  • Page 73: System Information

    System Overview Name Description System Logs Allows you to send logs to Philips in case of a system problem. For more information, “Sending System Logs” on page 153. Thermal Index Display Allows you to select the thermal index that you want to display. For more information, see “Setting the Thermal Index Display”...
  • Page 74 System Overview System Information Lumify Ultrasound System...
  • Page 75: Using The System

    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.
  • Page 76: Registering Your Transducers

    If your device prompts you to allow Lumify to access photos, media, or files on your device, touch Allow. If you touch Deny, you cannot use Lumify until you give access to shared device storage in the Android App Permissions settings.
  • Page 77: Updating The Lumify App

    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.
  • Page 78: 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.
  • Page 79: Setting The System Time And Date

    Setting the System Time and Date The Lumify app uses your device's clock and calendar function to display the time and date on the imaging display, and to provide a time stamp on patient exams and acquired images. If you change the time or date on your device, the Lumify app prompts you to restart.
  • Page 80 Patient information Scan plane orientation marker MI and TI values Focal indicator Page indicator: Touch the indicator to go to the next page of controls, or swipe to move between pages. Image information Review and settings menu Lumify Ultrasound System...
  • Page 81 Imaging Display Using the System Full-screen view control Centerline control In portrait orientation, the location of the controls area changes. Imaging Display (Portrait Orientation) Lumify Ultrasound System...
  • Page 82: Quick Exams

    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. Lumify Ultrasound System...
  • Page 83 On the imaging display, touch Quick ID. b. On the Patient Info display, type the patient information, query a Modality Worklist (MWL), or scan a barcode. For more information, see “Starting New Exams” on page c. Touch Save and Return. d. Resume imaging. Lumify Ultrasound System...
  • Page 84: Using Your Device's Camera As A Barcode Scanner

    Lumify remembers this information for subsequent barcode scans of the same format. The barcode you scan must meet the following conditions or Lumify will return an error: • There is a delimiter between strings. • The values must be unique.
  • Page 85: Saving Barcode Formats

    Using Your Device's Camera as a Barcode Scanner Using the System Saving Barcode Formats You can save multiple barcode formats. When Lumify scans a barcode, it searches the formats for the best match. 1. Do either of the following: • In the barcode viewfinder, touch •...
  • Page 86: Connecting Transducers

    Lumify app should open when the transducer (USB device) is connected. If you select Use By Default For This USB Device and touch OK, the Lumify app opens whenever the transducer is connected, regardless of which app is currently open on the device.
  • Page 87: Adding A Modality Worklist Server

    5. To specify advanced connection settings, select Show Advanced Options: • DNS Suffix: The DNS name without the hostname • Read Timeout (Sec): The network reply timeout • Connection Timeout (Sec): The DICOM ARTIM timeout 6. To test the connection to the server, touch Test. Lumify Ultrasound System...
  • Page 88: Modifying Or Deleting A Modality Worklist Server

    2. Select the Modality Worklist server you want to modify or delete. 3. Do one of the following: • To modify the Modality Worklist server, type settings or select options, and then touch Save. • To delete the Modality Worklist server, touch Lumify Ultrasound System...
  • Page 89: Performing An Exam

    Notifications and alerts from third-party applications may interfere with an exam. Starting New Exams 1. On the Scan/Create Patient display, touch an exam preset or drag the selector on the preset selector wheel to the exam preset you want. Lumify Ultrasound System...
  • Page 90 The last 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 Patient Info fields. Lumify Ultrasound System...
  • Page 91: Searching In The Worklist

    5. Do any of the following: • To see additional entries, swipe down. • To filter the Query Results, touch Search All Fields and type criteria. The system displays results that meet the criteria. 6. Select the patient from Query Results. Lumify Ultrasound System...
  • Page 92: Changing Presets During Exams

    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 Review display, do any of the following: Lumify Ultrasound System...
  • Page 93: Restarting A Paused Exam

    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 swipe to move between controls pages. • To control the image gain, adjust the Gain dial. Lumify Ultrasound System...
  • Page 94: Color Mode

    ) or swipe to display Fast Flow Slow Flow 3. Touch Fast Flow or 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.) Lumify Ultrasound System...
  • Page 95: Imaging Features

    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. Lumify Ultrasound System...
  • Page 96: Full-screen View

    If you spread or pinch inside a color box, you resize the color box instead of zooming. Full-Screen View You can specify that Lumify display live or frozen images in full-screen view, including in Review. 1. To view an image in full-screen view, touch in the lower right corner of the image.
  • Page 97: Measurement Accuracy

    If full-screen view is enabled on your device, the measurement is hidden when you touch . To restore the measurement, touch . You can, however, make an annotation on a measurement in Lumify full-screen view (see “Annotation” on page “Full-Screen View” on page 96).
  • Page 98: Measurement Accuracy Tables

    , and then do any of the following: • To select a frame to acquire, drag the scroll bar or touch to move through the images in the cineloop sequence to display the image that you want to acquire. Lumify Ultrasound System...
  • Page 99: Acquiring Loops

    . To stop acquisition, touch Stop. 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. Adding Labels Lumify Ultrasound System...
  • Page 100: Ending An Exam

    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. Lumify Ultrasound System...
  • Page 101 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 End Exam at the top of the imaging display. Lumify Ultrasound System...
  • Page 102 Performing an Exam Ending an Exam Lumify Ultrasound System...
  • Page 103: Review

    In Review, small images, called thumbnails, appear on the side or bottom of the Review display, depending on the screen orientation. From these thumbnails, you can display one or more images and loops in their original format. • To view a full-size image or loop, touch a thumbnail. Lumify Ultrasound System...
  • Page 104: Playing Loops

    Fast Forward control. Touch to move to the end of the loop. Loop time line. Drag to cycle through the loop at the specified loop speed. When the loop is paused, you can drag the line to a specific frame. Lumify Ultrasound System...
  • Page 105: E-mailing Images

    For more information, see Shared Roles for System and Data Security on your User Information CD or in the Support section of the Lumify portal (www.philips.com/lumify).
  • Page 106: Deleting Images And Loops

    • To export a single exam, touch it to open it in Review and then touch Export Exam • To export one or more exams, touch and hold an exam until Selected Exams appears. Touch additional exams to select them. Touch Export Lumify Ultrasound System...
  • Page 107: Showing Or Hiding Patient Data On Exported Images

    4. Do one of the following: • To show patient information on exported images and loops, select Include Patient Data on Each Image. • To hide patient information on exported images and loops, deselect Include Patient Data on Each Image. Lumify Ultrasound System...
  • Page 108: E-mailing Exams

    For more information, see Shared Roles for System and Data Security on your User Information CD or in the Support section of the Lumify portal (www.philips.com/lumify).
  • Page 109: Deleting Exams

    3. In the Add New Destination dialog box, type a Destination Nickname and select a Destination Type. Touch Continue. 4. Configure destination settings (see “Export Destination Settings” on page 110). 5. To test the connection to the export destination, touch Test. Lumify Ultrasound System...
  • Page 110: Export Destination Settings

    • Connection Timeout (sec): The DICOM ARTIM timeout • Retry Interval (sec) : How much time the system will wait before retrying a job to the server • Max Retries: How many retries the system will perform before failing the job Lumify Ultrasound System...
  • Page 111 • DNS Suffix Advanced • Retry Interval (sec) : How much time the system will wait before retrying a job to the Connection Settings server • Max Retries: How many retries the system will perform before failing the job Lumify Ultrasound System...
  • Page 112: Editing Export Destinations

    • To edit the export destination, touch the export destination and use the keyboard to modify fields and options. Touch Save. • To delete the export destination, touch and hold the export destination until Done appears. Touch Delete . Touch Yes to confirm the deletion. Lumify Ultrasound System...
  • Page 113: Viewing The Export Queue

    You can enable DICOM logging to troubleshoot DICOM connectivity issues. DICOM logging is an advanced feature for IT professionals. 1. Do one of the following: • Touch , select Export Queue , and then touch • Touch , select Export Destinations , and then touch Lumify Ultrasound System...
  • Page 114 Enabling DICOM Logging 2. To start logging, touch Start DICOM Logging. To stop logging, touch Stop DICOM Logging. 3. To view logs, touch View DICOM Logs From [Date and Time]. 4. To delete logs, touch Delete DICOM Logs. Lumify Ultrasound System...
  • Page 115: Transducers

    The system is optimized for use based on your transducer selection. Transducer Safety WARNING Use only Philips transducers and Philips-approved biopsy guides, covers, brackets, supplies, components, and accessories. Other brands may not properly fit Philips transducers. Improper installation may result in patient injury. WARNING Always remove the transducer from the patient before defibrillation.
  • Page 116: Clinical Applications And Transducers

    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.
  • Page 117: Acoustic Artifacts

    “Transducer Care” on page 125 section. You can also contact your local Philips representative. For contact information, see “Customer Service” on page 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.
  • Page 118 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. Lumify Ultrasound System...
  • Page 119 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. Lumify Ultrasound System...
  • Page 120: Transducer Covers

    Transducer Covers To prevent contamination by blood-borne pathogens, sterile transducer covers are required for needle guidance procedures. Philips recommends the use of qualified 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.
  • Page 121: Ultrasound Transmission Gels

    Sterile transducer covers are disposable and must not be reused. Ultrasound Transmission Gels For proper transmission of the acoustic beam, use the ultrasound transmission gel supplied by or recommended by Philips, or another glycol-, glycerol-, or water-based acoustic coupling medium. CAUTION Do not use lotion-based products or gels that contain mineral oil.
  • Page 122: Transducer Storage

    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. Lumify Ultrasound System...
  • Page 123: Daily And Long-term Storage

    5. In Transducer Tests, touch 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.
  • Page 124 Transducers Testing Transducers Lumify Ultrasound System...
  • Page 125: Transducer Care

    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.
  • Page 126 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. Lumify Ultrasound System...
  • Page 127 When handling a transducer, do not bump the transducer on hard surfaces. CAUTION Do not use a surgeon’s brush when cleaning transducers. Even the use of soft brushes can damage transducers. CAUTION Do not use a brush on the transducer label. Lumify Ultrasound System...
  • Page 128 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. Lumify Ultrasound System...
  • Page 129 The only part that can be wiped with 70% isopropyl alcohol or other alcohol-based disinfectant is the transducer housing and lens outlined in the figure. Do not allow fluid to enter any unsealed area of the transducer. Lumify Ultrasound System...
  • Page 130: Latex Product Alert

    CAUTION Use only liquid solutions to sterilize transducers. Using autoclave, gas (EtO), or other methods not approved by Philips will damage your transducer and void your warranty. CAUTION Do not soak the transducer for extended periods of time. Limit the time and depth that transducers are soaked in disinfectant solution to the minimum time recommended by the disinfectant manufacturer.
  • Page 131: Transducer Care Methods

    See the FDA Guidance document “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,” updated September 9, 2008, at the following website: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM070911.pdf Lumify Ultrasound System...
  • Page 132: Transducer And Cable Cleaning

    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. Lumify Ultrasound System...
  • Page 133: Cleaning A Transducer

    These general cleaning instructions must be followed for all non-TEE transducers and cables. After cleaning, you must disinfect or sterilize non-TEE transducers by following the appropriate procedures: • “Low-level Disinfecting of Transducers” on page 135 Lumify Ultrasound System...
  • Page 134 6. Wipe with a dry cloth if necessary. To dry the lens, use a soft cloth and a blotting motion instead of a wiping motion. 7. Examine the device and cable for damage such as cracks, splitting, sharp edges, or projections. If damage is evident, discontinue use of the device and contact your Philips representative. NOTE If you use cleaning wipes, it may be unnecessary to rinse the transducer with water.
  • Page 135: Low-level Disinfecting Of Transducers

    Low-level disinfection of USB transducers uses the spray or wipe method, with a low-level or intermediate-level disinfectant. Before disinfecting a transducer, read the warnings and cautions in “Safety” and in “Transducer Care and Operator Safety” on page 125. WARNING Always use protective eyewear and gloves when cleaning and disinfecting any equipment. Lumify Ultrasound System...
  • Page 136 Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. If a pre-mixed solution is used, be sure to observe the solution expiration date. Lumify Ultrasound System...
  • Page 137: High-level Disinfecting Of Transducers

    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. Lumify Ultrasound System...
  • Page 138 6. Air dry or towel dry with a sterile cloth according to the instructions on the disinfectant label. 7. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips representative. Lumify Ultrasound System...
  • Page 139: Minimizing The Effects Of Residual Disinfectant

    If you use an OPA (ortho-phthalaldehyde) based disinfectant, residual solution may remain on your transducers if you do not carefully follow the manufacturer’s instructions. To minimize the effects from residual OPA, or any other disinfectant, Philips recommends the following: • Follow the disinfectant manufacturer’s instructions very carefully. For example, the manufacturer of Cidex OPA recommends rinsing transducers by immersing them three times in fresh water.
  • Page 140: Disinfectants Compatibility

    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. Lumify Ultrasound System...
  • Page 141 “Transducer Care Methods” on page 131. For more information, 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. Lumify Ultrasound System...
  • Page 142: Disinfectants And Cleaning Solutions For Transducers

    The following table lists the disinfectants and cleaning solutions compatible with the transducers available for your Philips ultrasound system. Based on material compatibility testing, product use profile, and active ingredients, Philips has approved for use the following types of low-level disinfectants used as a spray or wipe for...
  • Page 143 If you are unsure of the suitability of a particular product, please contact your Philips representative for more information: • In North America, call Philips at 800-722-9377. • Outside North America, contact your local Philips representative. Disinfectants and Cleaning Solutions Compatibility Table Legend Origin (Country...
  • Page 144 LLD, ILD AbcoCide Soak Glutaraldehyde HLD, S AbcoCide 28 Soak Glutaraldehyde HLD, S Accel Wipes (all types) Wipe Hydrogen Peroxide LLD, ILD Acecide Soak Peracetic acid Aidal Plus Soak Glutaraldehyde HLD, S Alkaspray Spray/Wipe Alcohol, Alkylamine LLD, ILD Lumify Ultrasound System...
  • Page 145 Soak Glutaraldehyde HLD, S Cidex OPA Soak Ortho-phthalaldehyde Cidex PAE 14J Soak Glutaraldehyde HLD, S Cidex Plus Soak Glutaraldehyde HLD, S Cleanisept Wipes Spray/Wipe Quat. Ammonia LLD, ILD Clinell Universal Sanitising Spray/Wipe Quat, Biquanide LLD, ILD Wipes Lumify Ultrasound System...
  • Page 146 Pre-cleaner Chlorhexidine gluconate Incidin Spray/Wipe Alcohol LLD, ILD Inciden Rapid Spray/Wipe Quat, Glutaraldehyde LLD, ILD Incidur Spray Spray/Wipe Alcohol, Quat, Aldehyde LLD, ILD Instruzyme Pre-cleaner Enzymes, Quat. Ammonia, Biguanide Klenzyme Pre-cleaner Enzymes Korsolex Basic Soak Aldehyde Releasing Lumify Ultrasound System...
  • Page 147 Mild Soap Solution Pre-cleaner Surfactants/Soap Milton Spray/Wipe Sodium Hypochlorite LLD, ILD NDP Med Concentrated Soak N-Duopropenide, Plus Alkylamine Neodisher endo CLEAN / Peracetic acid CL, HLD Neodisher endo SEPT PAC Neodisher endo DIS active Soak Peracetic acid Lumify Ultrasound System...
  • Page 148 Quat. Ammonia LLD, ILD PI-Spray II Spray/Wipe Quat. Ammonia LLD, ILD (Formerly T‑Spray II) ProCide-D Soak Glutaraldehyde HLD, S ProCide-D Plus Soak Glutaraldehyde HLD, S Prolystica 2X Pre-cleaner Enzymes Protex Disinfectant Spray Spray/Wipe Quat. Ammonia LLD, ILD Lumify Ultrasound System...
  • Page 149 Sani-Cloth Plus Wipe Alcohol, Quat. Ammonia LLD, ILD Sekucid N Soak Glutaraldehyde HLD, S Sekusept Aktiv Soak Peracetic acid Sekusept Easy Soak Peracetic acid Sekusept Plus Soak Glucoprotamine Soluscope P Peracetic acid Steranios 2% Soak Glutaraldehyde HLD, S Lumify Ultrasound System...
  • Page 150 1. Never immerse or soak a connector. 2. Mild soap solutions do not contain any harsh ingredients and are not irritating to the skin. They must not contain fragrance, oils, or alcohols. Hand sanitizers are not approved for use. Lumify Ultrasound System...
  • Page 151: System Maintenance

    System Maintenance Maintenance should be performed regularly and as needed. Because the system is a piece of medical equipment, Philips recommends that only trained personnel service the system. Follow all instructions provided to avoid damage during cleaning, disinfection, and sterilization, which could void your warranty.
  • Page 152: Transducer Maintenance

    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.
  • Page 153: Sending System Logs

    Sending System Logs System Maintenance Sending System Logs The Lumify app sends system logs to Philips periodically. You can explicitly send system logs to Philips in case of a system problem. For information about privacy, see the Lumify Privacy Notice (touch , touch About, and then touch Privacy Notice).
  • Page 154: Error Messages

    Run the transducer test. See “Testing Transducers” on page 123. Error Messages The system displays error messages in response to operating or error conditions detected by the system. The error messages must be noted and reported to your Philips representative. Lumify Ultrasound System...
  • Page 155: For Assistance

    For Assistance System Maintenance For Assistance If you are unable to correct a problem, call your local Philips representative or visit the Lumify portal: www.philips.com/lumify The Lumify portal includes a list of frequently asked questions (FAQs) which can help you troubleshoot problems.
  • Page 156 System Maintenance For Assistance Lumify Ultrasound System...
  • Page 157: Specifications

    User interface and documentation in English only. Pressure, Humidity, and Temperature Limits These limits apply only to the Philips Lumify transducers, not to the Android device on which you run the Lumify app. It is your responsibility to select a Lumify-compatible device that meets the needs of your clinical environment.
  • Page 158: Safety And Regulatory Requirements

    Compliance Philips products comply with relevant international and national standards and laws. Information on compliance will be supplied by your local Philips representative, or the manufacturer, on request. Lumify Ultrasound System...
  • Page 159: Index

    Centerline related guidance documents 46 displaying 96 Alcohol, restricted use on transducers 129 CIVCO Medical Solutions 16 Allergic reactions to latex 35 Cleaning Annotation 99 cables 132 App updates 77 device 151 Artifacts 117 transducers 125, 132 Lumify Ultrasound System...
  • Page 160 Disposal of device 17 Customer Distance measurements service 17 performing 96 Downloading app 75 Data storage 72 Editing patient data 92 Date and time, setting 79 Electrical safety 24 Defibrillation, electrical safety 24, 27 Electromagnetic compatibility 53 Deleting exams 109 Lumify Ultrasound System...
  • Page 161 24 deleting 109 explosion 11, 24 e-mailing 108 IEC symbols 30 ending 100 High-level disinfection 137 exporting 106 quick 82 restarting paused 93 Icons reviewing 92 imaging display 79 starting new 89 IEC symbols 30 Lumify Ultrasound System...
  • Page 162 99 on-screen 41 Latex Medical Ultrasound Safety 12 allergic reactions 35 Messages, error 33, 154 in Philips products 130 MI 41 Leakage current 25 MI and TI accuracy estimates 41 Local directory export settings 110 Modality Worklist 86 Logging, DICOM 113...
  • Page 163 Index Modality Worklist server Philips contact information 17 configuring 87 Playing loops 104 deleting 88 Portal 155 modifying 88 Power troubleshooting 153 Power saving 72 Power, output 72 Navigating thumbnails and images 103 Presets, changing 92 Network share export settings 110...
  • Page 164 30 Security warning 12 data 70 System error messages 154 Separation distance 62 System Information 73 Serial number, transducer 73 System logs 72, 153 Service, customer 17 System maintenance 151 System settings 72 System upgrades 16 Lumify Ultrasound System...
  • Page 165 Transducer maintenance 116, 152 safety 115 serial number 73 sterilizing 125 storage, daily and long-term 123 storage, for transport 122 storing 122 test 123 tests 72 using 115 Troubleshooting 153 Turning the system on and off 78 Tutorial 77 Lumify Ultrasound System...
  • Page 166 9 components 12 conventions 13 User Information CD 12 Walkthrough 77 Warning symbols 12, 30 Warnings described 21 general 11, 21 symbols 12 Website, Philips 17 Wireless networking 70 Worklist 86 searching for exams 91 Zoom 95 Lumify Ultrasound System...
  • Page 168 Philips Healthcare is part of Royal Philips www.philips.com/healthcare healthcare@philips.com Manufacturer’s address Philips Ultrasound, Inc. 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands 0086 © 2016 Koninklijke Philips N.V. All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner.

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