Premium General-Purpose Ultrasound Scanners, Focusing on the Mindray Resona 7
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Membership Content Technology Decision Support EVALUATION Premium General-Purpose Ultrasound Scanners, Focusing on the Mindray Resona 7 A Report Excerpted from the Device Evaluation Website | May 2021 Also Includes Ratings and Purchasing Advice for: Canon Medical Systems Aplio i800 Philips Healthcare Epiq Elite Samsung RS85 Prestige Siemens Healthcare Solutions Acuson Sequoia Siemens Healthineers Acuson S3000 HELX Evolution with Touch Control Toshiba America Medical Systems Aplio 500 The Most Trusted Voice in Healthcare e clientservices@ecri.org | w www.ecri.org |
ABOUT THIS REPRINT This report reprints material from the Device Evaluation website as of December 22, 2020. It does not reflect modifications that may have been made after that date. Restrictions on the use of Device Evaluation content: As an impartial evaluator of biomedical technology, ECRI does not endorse any specific brand or model of device. Reproducing excerpts from our product Evaluations in promotional materials implies endorsement, contravenes ECRI policy, and may violate copyright law. Please report any instances of improper use of our published materials directly to: Legal Department, ECRI. ABOUT ECRI’S EVALUATIONS We evaluate a broad range of diagnostic and therapeutic technologies, examining safety, effectiveness, cost, human factors, and other essential elements. We rate products on a scale of one to five stars, with five stars being the highest. We assign ratings based on (1) the criteria we establish and (2) comparison with the performance of similar products on the market. Our criteria and ratings can change as a technology evolves—for example, as a once-groundbreaking feature becomes routinely available and no longer constitutes a purchasing advantage. All of our studies are intensively reviewed by engineering and clinical professionals, both within and outside the organization, before publication. ABOUT ECRI—THE MOST TRUSTED VOICE IN HEALTHCARE As a nonprofit, independent organization, we utilize an unbiased, evidence-based approach to develop guidance, and maintain our principles of integrity and transparent work. Tens of thousands of healthcare leaders worldwide—from providers and insurers to gov- ernment agencies and medical associations—rely on ECRI to guide their clinical, operational, and strategic decisions across all sites of care. Our areas of focus include: ― Patient Safety: empowering leaders to eliminate patient harm through the dissemination of best practices, guidance, benchmarking, and recommendations. ― Evidence-Based Medicine: providing clinical evidence to inform and support decisions on the effectiveness of medical technologies, procedures, genetic tests, and clinical practice guidelines. ― Technology Decision Support: arming hospital systems with unbiased insights, so they can optimize their supply chain. ECRI respects and is impartial toward all ethical medical device companies and practices. We do not endorse any specific brand or model of device, and we have strict conflict-of-interest rules that govern our work. In addition, neither ECRI nor any of its staff mem- bers has a direct or indirect financial interest in promoting the sale of any medical device. Our employees do not undertake private consulting work for the medical device industry or own stock in medical device companies. We accept no royalties, gifts, finder’s fees, or commissions from the medical device industry, nor do we accept advertising. ALL MATERIAL COPYRIGHT ©2021 ECRI All rights reserved. All rights are reserved under international and Pan-American copyright conventions. All material in ECRI publications is protected by copyright. Reproduction. Except where otherwise noted, ECRI prohibits reproduction of this material by anyone, by any means, for any purpose, without prior written permission. Reproduction for commercial purposes is expressly prohibited.
EVALUATION Premium General-Purpose Ultrasound Scanners, Focusing on the Mindray Resona 7 A Report Excerpted from the Device Evaluation Website | May 2021 This report focuses on our Evaluation of the Mindray Resona 7 premium general-purpose ultrasound scanner. For perspective, it also includes our findings for the other products we evaluated: the Canon Medical Systems Aplio i800, Philips Healthcare Epiq Elite, Samsung RS85 Prestige, Siemens Healthcare Solutions Acuson Sequoia, Siemens Healthineers Acuson S3000 HELX Evolution with Touch Control, and Toshiba America Medical Systems Aplio 500. A summary of our findings is presented below and on the next 5 pages. Our detailed Evaluation results for the Resona 7 begin on page 9. RATINGS: PREMIUM GENERAL-PURPOSE ULTRASOUND SCANNERS Cost of Ownership (Estimated) Where Patient Interop- Cyber- User over Seven Model Marketed Rating Performance Safety Workflow Experience erability security Maintenance Experience Years Mindray Resona 7 Worldwide Excellent Good Good Not Good Good Good Good Good; Last updated 6/2019 evaluated $137,000 Canon Aplio i800 Worldwide Excellent Good Excellent Not Good Good Good Good Good; Last updated 11/2019 evaluated $220,000 Philips Epiq Elite Worldwide Excellent Good Good Not Good Good Good Good Good; Last updated 12/2020 evaluated $190,000 Samsung RS85 Prestige Worldwide Excellent Good Fair Not Good Good Good Excellent Good; Last updated 12/2020 evaluated $210,000 Siemens Acuson S3000 Worldwide Excellent Good Excellent Not Good Not Good Good Good; HELX Evolution with evaluated evalu- $220,000 Touch Control ated Last updated 6/2017 Siemens Acuson Sequoia Worldwide Excellent Good Good Not Good Good Good Excellent Good; Last updated 12/2020 evaluated $200,000 Toshiba Aplio 500 Worldwide Excellent Good Good Not Good Not Good Good Good; Last updated 11/2016 evaluated evalu- $152,000 ated ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 3 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Summary of Findings: Premium General-Purpose Ultrasound Scanners MINDRAY RESONA 7 CANON MEDICAL SYSTEMS APLIO I800 Rating Rating Findings Where Marketed The Resona 7 is a premium general-purpose ultrasound scan- As of the time of publication, this product is sold worldwide. ner that offers B-mode, M-mode, and Doppler capabilities and supports a wide range of transducers for general imaging appli- Findings cations. A number of options are available that have the potential The Aplio i800 is a premium general-purpose ultrasound scanner to enhance the clinical performance of the scanner, as well as that offers B-mode, M-mode, and Doppler capabilities and sup- improve workflow. ports a wide range of transducers for general imaging applications. Our rating is based on the following findings: We evaluated the device for both general-purpose (GP) applica- tions and obstetric and gynecologic (OB/GYN) applications. A num- Performance—Excellent. The Resona 7 met our required B-mode ber of options are available that have the potential to enhance the and Doppler performance criteria. The scanner demonstrated clinical performance of the scanner, as well as improve workflow. advantages in its optional advanced technologies of strain and Our ratings are based on the following findings: shear-wave elastography, fusion imaging and needle navigation, and contrast-enhanced ultrasound imaging. Performance—Excellent (GP applications); Good (OB/GYN applications). The Aplio i800’s advantages include the optional Safety—Good. The Resona 7 met our safety criteria, including advanced technologies of strain and shear-wave elastography, fulfilling all recommendations in the Industry Standards for the fusion imaging, contrast-enhanced ultrasound imaging, excellent Prevention of Work-Related Musculoskeletal Disorders in Sonogra- B-mode axial resolution, and strain imaging for fetal echocardiog- phy, published by the Society of Diagnostic Medical Sonography. raphy studies. Workflow—Good. The Resona 7 met our required workflow criteria Safety—Good (GP and OB/GYN). The scanner met our required and demonstrated advantages in being able to simultaneously safety criteria, including those pertaining to the Industry Standards display in real time conventional B-mode and contrast-enhanced for the Prevention of Work-Related Musculoskeletal Disorders ultrasound data, and for having multiple ways to import data for in Sonography, published by the Society of Diagnostic Medi- fusion imaging. cal Sonography. Patient Experience—Not evaluated. The patient experience is not Workflow—Excellent (GP); Good (OB/GYN). The scanner met our a purchasing factor for these devices. required workflow criteria, and has advantages related to automat- Interoperability—Good. The Resona 7 met our required interop- ed gynecologic data acquisition, measurement, and calculation erability criteria. The scanner can communicate via Ethernet with capabilities, as well as other features that enhance its usability for a hospital information system (HIS) and picture archiving and both conventional and advanced GP applications. communication system (PACS). Wi-Fi is available as an option. Patient Experience—Not evaluated. Patient experience is not a Cybersecurity—Good. The scanner met our required cybersecu- purchasing factor for these devices. rity criteria. Interoperability—Good (GP and OB/GYN). The Aplio i800 met our Maintenance—Good. The vendor does not specify the frequency required interoperability criteria. The scanner can communicate of inspection and preventive maintenance procedures, allowing via Ethernet with a hospital information system (HIS) and picture facilities to set their own frequency. archiving and communication system (PACS). Wi-Fi is available User Experience—Good. Surveyed users confirmed the findings as an option. of our tests. Cybersecurity—Good (GP and OB/GYN). The scanner met our Cost of Ownership—Good; $137,000 (estimated) over seven years required cybersecurity criteria. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 4 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Summary of Findings: Premium General-Purpose Ultrasound Scanners Maintenance—Good (GP and OB/GYN). The vendor recommends Our rating is based on the following findings: annual inspection and preventive maintenance. Several mainte- Performance—Excellent. The Epiq Elite met ECRI’s required perfor- nance options are available. mance criteria, including supporting advanced modes such as User Experience—Good (GP and OB/GYN). Surveyed users con- elastography, contrast-enhanced imaging, 3D/4D, fusion imaging, firmed the findings of our Evaluation. and needle navigation. The scanner offers the vendor’s Micro Flow Cost of Ownership—Good (GP and OB/GYN). Estimated at Imaging HD (MFI HD) advanced blood flow detection mode. $220,000 for GP applications and $230,000 for OB/GYN applications Safety—Good. The scanner met our required safety criteria. over seven years. Note that these calculations are based on prices Workflow—Good. The Epiq Elite demonstrated workflow ad- for the United States, a major market for the product. vantages in having a battery-operated standby mode and Auto Color, which is an automated image optimization feature for color Considerations for Challenging Environments Doppler imaging (CDI). No significant challenges or concerns. The Aplio i800 is designed Patient Experience—Not evaluated. The patient experience is not to be used in a controlled hospital environment by trained a purchasing factor for these devices. operators. Hospitals have biomedical engineers to perform Interoperability—Good. The scanner met our required interopera- preventive maintenance, and service contracts that include OEM bility criteria. service are common. Cybersecurity—Good. The manufacturer has completed ECRI’s PHILIPS HEALTHCARE EPIQ ELITE cybersecurity questionnaire, which allows us to identify the cyber- security capabilities of the scanner. We judged the responses to Rating be satisfactory. Maintenance—Good. The scanner met our required mainte- nance criteria. Where Marketed User Experience—Good. Surveyed users confirmed the findings of our tests. As of the time of publication, this product is sold worldwide. Cost of Ownership—Good; $190,000 (estimated) over seven years Findings for an installation including four two-dimensional (2D) transducers The Epiq Elite is a premium general-purpose ultrasound scan- commonly used for general-purpose applications. This calcula- ner that offers B-mode, M-mode, and Doppler capabilities and tion is based on prices for the United States, a major market for supports a wide range of transducers for general imaging appli- the product. cations. A number of options are available that have the potential to enhance the clinical performance of the scanner, as well as Considerations for Challenging Environments improve workflow. These scanners are typically used in hospital radiology depart- ments and vascular laboratories by ultrasound imaging profes- The Epiq Elite is a very good choice for general-purpose ultrasound sionals. There are no significant concerns for use of this product applications and, when configured with the required options, may in challenging environments. However, users should be aware be used for advanced applications that include strain and shear- that there are limits for use of the device in extremely humid, cold, wave elastography, contrast-enhanced imaging, fusion imaging, or hot environments. Also, as with any ultrasound scanner, parts needle navigation, and 3D and 4D (i.e., real-time 3D) imaging. The and servicing in remote areas may involve delays and increased scanner supports desirable workflow enhancements such as auto- shipment costs. mated image optimization features, as well as Wi-Fi connectivity. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 5 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Summary of Findings: Premium General-Purpose Ultrasound Scanners SAMSUNG RS85 PRESTIGE security capabilities of the scanner. We judged the responses to be satisfactory. Rating Maintenance—Good. The scanner met our required mainte- nance criteria. User Experience—Excellent. Surveyed users confirmed the find- Where Marketed ings of our tests. As of the time of publication, this product is sold worldwide. Cost of Ownership—Good; $210,000 (estimated) over seven years for an installation including four 2D transducers commonly used Findings for general-purpose applications. This calculation is based on pric- The Samsung RS85 Prestige is a premium general-purpose es for the United States, a major market for the product. The RS85 ultrasound scanner that offers B-mode, M-mode, and Doppler Prestige has a five-year warranty standard. capabilities and supports a wide range of transducers for general imaging applications. A number of options are available that have Considerations for Challenging Environments the potential to enhance the clinical performance of the scanner, These scanners are typically used in hospital radiology depart- as well as improve workflow. ments and vascular laboratories by ultrasound imaging profes- sionals. There are no significant concerns for use of this product The RS85 Prestige is a good choice for general-purpose applica- in challenging environments. However, users should be aware tions and, when configured with the required options, may be that there are limits for use of the device in extremely humid, cold, used for advanced applications that include strain and shear-wave or hot environments. Also, as with any ultrasound scanner, parts elastography, contrast-enhanced imaging, fusion imaging, needle and servicing in remote areas may involve delays and increased navigation, and 3D and 4D (i.e., real-time 3D) imaging. The scanner shipment costs. supports desirable workflow enhancements such as automated Doppler optimization features and Wi-Fi connectivity. Our rating is based on the following findings: SIEMENS HEALTHCARE SOLUTIONS Performance—Excellent. The RS85 Prestige met ECRI’s required ACUSON SEQUOIA performance criteria, including supporting advanced modes such Rating as elastography, contrast-enhanced imaging, 3D/4D, fusion imag- ing, and needle navigation. The scanner offers up to 43 cm (16.9 in) of B-mode penetration and offers the vendor’s MV-Flow advanced blood flow detection mode. Where Marketed Safety—Good. The scanner met our required safety criteria. As of the time of publication, this product is sold worldwide. Workflow—Fair. The RS85 Prestige offers automated data ac- Findings quisition features for general-purpose applications, but lacks an The Sequoia is a premium general-purpose ultrasound scan- effective automated B-mode image optimization feature. ner that offers B-mode, M-mode, and Doppler capabilities and Patient Experience—Not evaluated. The patient experience is not supports a wide range of transducers for general imaging appli- a purchasing factor for these devices. cations. A number of options are available that have the potential Interoperability—Good. The scanner met our required interopera- to enhance the clinical performance of the scanner, as well as bility criteria. improve workflow. Cybersecurity—Good. The manufacturer has completed ECRI’s The Sequoia is a very good choice for general-purpose applica- cybersecurity questionnaire, which allows us to identify the cyber- tions and, when configured with the required options, may be ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 6 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Summary of Findings: Premium General-Purpose Ultrasound Scanners used for advanced applications that include strain and shear-wave SIEMENS HEALTHINEERS ACUSON S3000 elastography, contrast-enhanced imaging, fusion imaging, and needle navigation. The scanner supports desirable workflow en- HELX EVOLUTION WITH TOUCH CONTROL hancements such as automated image optimization features and Rating Wi-Fi connectivity. Our rating is based on the following findings: Performance—Excellent. The scanner met ECRI’s required perfor- Findings mance criteria, including supporting advanced modes such as elas- The Acuson S3000 HELX Evolution with Touch Control is a premium tography, contrast-enhanced imaging, fusion imaging, and needle general-purpose ultrasound scanner that offers B-mode, M-mode, navigation. 3D and 4D (i.e., real-time 3D) imaging is supported on and Doppler capabilities and supports a wide range of transducers the endocavity probe. The scanner also offers up to 40 cm (15.7 in) for general imaging applications. A number of options are available B-mode penetration when using the DAX transducer, as well as the that have the potential to enhance the clinical performance of the vendor’s S-Flow advanced blood flow detection mode. scanner as well as improve workflow. Safety—Good. The scanner met our required safety criteria. Our rating is based on the following findings: Workflow—Good. The scanner offers a hibernation mode. Performance—Excellent. The Acuson S3000 met all of our required Patient Experience—Not evaluated. The patient experience is not B-mode and Doppler performance criteria. The scanner offers a purchasing factor for these devices. advantages in its optional advanced technologies of strain and Interoperability—Good. The scanner met our required interopera- shear-wave elastography, fusion imaging and needle navigation, bility criteria. contrast-enhanced ultrasound imaging, and 3D and 4D imaging. Cybersecurity—Good. The manufacturer has completed ECRI’s Safety—Good. The scanner met all of our safety criteria, including cybersecurity questionnaire, which allows us to identify the cyber- fulfilling all recommendations in the Industry Standards for the security capabilities of the scanner. We judged the responses to Prevention of Work-Related Musculoskeletal Disorders in Sonogra- be satisfactory. phy, published by the Society of Diagnostic Medical Sonography, Maintenance—Good. The scanner met our required mainte- as well as ECRI’s established security criteria. nance criteria. Workflow—Excellent. The scanner met our workflow criteria and User Experience—Excellent. Surveyed users confirmed the find- demonstrated several advantages that enhance its use for both ings of our tests. conventional and advanced applications. Cost of Ownership—Good; $200,000 (estimated) over seven years Patient Experience—Not evaluated. The patient experience is not for an installation including four 2D transducers commonly used a purchasing factor for these devices. for general-purpose applications. This calculation is based on pric- Interoperability—Good. The scanner can communicate via Ether- es for the United States, a major market for the product. net with a hospital information system (HIS) and picture archiving and communication system (PACS). Wi-Fi is available as an option. Considerations for Challenging Environments Maintenance—Good. The scanner requires inspection and preven- These scanners are typically used in hospital radiology depart- tive maintenance once every 24 months. ments and vascular laboratories by ultrasound imaging profes- sionals. There are no significant concerns for use of this product User Experience—Good. Surveyed users confirmed our findings. in challenging environments. However, users should be aware Cost of Ownership—Good. Based on ECRI’s SELECTplus database that there are limits for use of the device in extremely humid, cold, of scanners in this category, the typical cost of the Acuson S3000 or hot environments. Also, as with any ultrasound scanner, parts HELX Evolution with Touch Control is higher than average. and servicing in remote areas may involve delays and increased shipment costs. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 7 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Summary of Findings: Premium General-Purpose Ultrasound Scanners TOSHIBA AMERICA MEDICAL SYSTEMS APLIO 500 Rating Findings The Aplio 500 is a premium general-purpose ultrasound scan- ner that offers B-mode, M-mode, and Doppler capabilities and supports a wide range of transducers for general imaging applica- tions. A number of options are available that have the potential to enhance the clinical performance of the scanner as well as improve workflow. Our rating is based on the following findings: Performance—Excellent. The Aplio 500 met all of our required B-mode and Doppler performance criteria. The scanner received advantages based on its optional advanced technologies of strain and shear-wave elastography, fusion imaging and nee- dle navigation, contrast-enhanced ultrasound imaging, and 3D and 4D imaging. Safety—Good. The Aplio 500 met all of our safety criteria, including fulfilling all recommendations in the Industry Standards for the Prevention of Work-Related Musculoskeletal Disorders in Sonogra- phy and ECRI’s established security criteria. Workflow—Good. The Aplio 500 demonstrated several workflow advantages that enhance the use of the scanner for both conven- tional and advanced applications; however, we found the complex user interface to be a major disadvantage. Patient Experience—Not evaluated. The patient experience is not a purchasing factor for these devices. Interoperability—Good. The Aplio 500 can communicate via Ether- net with a hospital information system (HIS) and picture archiving and communication system (PACS). Wi-Fi is available as an option. Maintenance—Good. The Aplio 500 requires inspection and pre- ventive maintenance once per year. User Experience—Good. Surveyed users confirmed the findings of our tests. Cost of Ownership—Good. Based on ECRI’s SELECTplus database of scanners in this category, the typical cost of the Aplio 500 is lower than average. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 8 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 RATING (2) The console dimensions (W × D × H) are 54.4 × 94.5 × [136 to 167] cm (21.4 × 37.2 × [53.5 to 65.7] in). It weighs 135 kg (297 lb) and has 12.5 cm (5 in) double casters that all The Resona 7 is a very good choice for general-purpose applica- have swivel locks and brakes that the user can engage tions and, when configured with the required options, may be and disengage, both independently and with a central used for advanced applications that include strain and shear-wave foot control located on the front of the scanner. On the elastography, fusion imaging, contrast-enhanced imaging, needle front of the console above the transducer ports there is a navigation, and 3D and 4D (i.e., real-time 3D) imaging. The scanner USB port, a microphone input, and a patient physiologic met our required criteria, including those for safety and cyberse- data input port. A DVD+RW drive is on the left side of the curity, and incorporates desirable workflow enhancements such console, and a data input/output panel is on the rear as simultaneous display of conventional B-mode and contrast-en- that includes three USB ports, one HDMI output, one hanced ultrasound (CEUS) images and the ability to fuse ultra- network port, one VGA output, one S-Video output, and sound images with imported data. The scanner offers wired and L/R audio output ports. optional Wi-Fi connectivity. b) A control panel user interface (1) The control panel is used to enter patient data, select DEVICE DETAILS transducers, select presets and imaging modes, adjust ― Name: Resona 7 image quality, obtain measurements, annotate images, ― Date evaluated: June 2019 and perform calculations. The scanner supports the ven- ― Manufacturer: Mindray Medical International Ltd. [455416] dor’s ZONE Sonography Technology (ZST) and various ― Healthcare Product Comparison System (HPCS) comparison modes and features, including: M-mode, anatomical chart: Scanning Systems, Ultrasonic, General-Purpose M-mode, pulsed-wave (PW) Doppler, continuous-wave (HPCS is available to members of Health Devices Gold (CW) Doppler, Color Doppler Imaging (CDI), power and SELECTplus.) Doppler imaging (PDI), tissue Doppler imaging (TDI) ― Software version evaluated: 2.51 and PW-tissue Doppler, V Flow, tissue harmonic imag- ing (THI), Dynamic Pixel Focusing (DPF), Sound Speed DEVICE DESCRIPTION Compensation (SSC), Total Recall Imaging (TRI), UWN+ 1. T he Mindray Resona 7 is a general-purpose (GP) ultrasound (Ultra-Wideband Non-linear Plus) contrast imaging, scanner that can be configured for specific applications. contrast imaging quantification and analysis (QA), Sound Touch Elastography (STE), iBeam Spatial Compound a) These scanners are typically used to perform ultrasound ex- Imaging, iClear Speckle Suppression Imaging, iTouch aminations of the abdomen, pelvis, and superficial structures Auto Image Optimization, iNeedle Needle Visualization such as the thyroid gland, testes, and breast. Enhancement, extended field of view, HD Scope, and b) They are also used for ultrasound guidance during interven- iWorks exam protocols. tional procedures such as needle biopsies and fluid drainages. (2) The control panel is a “floating” (i.e., position-adjust- 2. T he major device components and software features include: able) design, with electronic up/down and side-to-side a) A console position controls; the scanner must be powered on to use these controls. There is a 30.7 cm (12.1 in) high-reso- (1) The console contains a computer that controls the lution color LCD touchscreen that tilts to allow opti- ultrasound signal generator, receiver, and processor. The mal viewing, QWERTY hard keyboard, trackball, hard console also contains a 1 TB hard drive and a 120 GB sol- controls, and softkeys that change function based on the id-state drive for onboard data storage, and has data input mode of operation. There is one audio speaker on each and output ports. side of the control panel. A handle is used to position the ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 9 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 control panel during exams and for transport. Integrated (3) Gel-bottle warmer to maintain scanning gel at a us- into the control panel are transducer holders, a gel-bot- er-selectable temperature of 34°C, 37°C, or 40°C (93.2°F, tle holder, and transducer cable hooks. 98.6°F, or 104°F) for patient comfort c) A 54.6 cm (21.5 in) high-resolution, flat-panel LED video (4) ECG module to input patient physiologic data such as display used to view ultrasound images and other data. ECG into the scanner for correlation with imaging data The display has a wide viewing angle and is attached to (5) Footswitch with programmable functionality to allow the scanner on an articulated arm to allow users to posi- foot activation of commonly used controls such as freeze tion it separately from the console panel for optimal use and print during examinations. Two-switch and three- during exams. The display can be folded down and locked switch models are available. during transport. (6) One-dimensional and two-dimensional bar-code read- d) Four transducer ports, used to connect the scanner’s pinless ers, which allow patient bar-code data to be imported transducer connectors to the scanner. The ports are located into the scanner for efficient data entry. The use of a on the lower front of the console. There is also an inactive bar-code reader also reduces data-entry error compared port that can hold a probe connector. A blue light in the with manual entry. probe connector indicates the active probe. (7) Integrated wireless adapter for a Wi-Fi connection 3. Typical locations where the Resona 7 is used include: b) Software a) Hospital radiology department (1) Natural Touch Elastography (strain elastography) b) Freestanding imaging facility (2) STE Sound Touch Elastography (shear- c) Private physician office wave elastography) 4. Optional hardware and software. Because the Resona 7 is a GP (3) STQ Sound Touch Elastography (quantitative anal- scanner that can be configured for general, cardiac, vascular, ysis for STE) obstetrics and gynecology (OB/GYN), and shared service ap- (4) Contrast imaging plications, there are a large number of hardware and software options available. Listed below are the typical options used on (5) Contrast imaging quantitative analysis (QA) package a scanner for GP applications: (6) iFusion a) Hardware (7) Needle Navigation Guiding (1) Application-specific transducers—see the table Trans- (8) iNeedle enhanced needle-visualization mode ducers Supported by the Resona 7 on the next page. (9) iScape View real-time panoramic imaging (2) Integrated DVR to digitally record images and video clips (10) Application-specific quantification and analysis soft- to removable media ware packages including obstetric and gynecologic ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 10 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 TRANSDUCERS SUPPORTED BY THE RESONA 7 The following data was provided by the vendor. Frequency Biopsy Elastography Contrast-Enhanced Fusion Model ID and Type Range (MHz) Applications Attachment Type Imaging Imaging SC6-1U* 1.0-6.0 Abdomen, obstetric and gynecologic (OB/GYN), vascular Yes Shear wave Yes Yes Convex linear array (CLA) SC8-2U* 1.8-8.2 Abdomen, OB/GYN, pediatric — — Yes Yes CLA C4-1U 1.0-4.5 Abdomen, OB/GYN, vascular Yes — Yes Yes CLA C6-2GU 1.2-6.0 Abdomen, OB/GYN, pediatric Yes Shear wave Yes — CLA C11-3U 2.6-12.8 Neonatal head, pediatric Yes — — — CLA L14-5WU 4.0-14.0 Musculoskeletal (MSK), nerve, pediatric, small parts, — Strain, shear Yes Yes Flat linear array (FLA) vascular wave L14-6WU 4.0-14.0 MSK, nerve, pediatric, small parts, vascular — Strain — — FLA L20-5U 7.6-20.0 MSK, nerve, small parts, vascular — Strain — — FLA L9-3U 1.8-9.8 Abdomen, MSK, nerve, obstetric, pediatric, small parts, Yes Strain, shear Yes — FLA vascular wave L11-3U 3.0-10.0 Abdomen, obstetric, pediatric, small parts, MSK, nerve, Yes Strain, shear Yes Yes FLA vascular wave L16-4HU 3.5-16.0 Intraoperative, MSK, nerve, pediatric, small parts, vascular — Strain — — FLA P10-4U 3.0-11.4 Pediatric abdomen, pediatric cardiac, neonatal — — — — Sector P7-3U 2.3-8.0 Abdomen, cardiac, pediatric — — — — Sector V11-3HU 3.0-11.0 OB/GYN, urology Yes — Yes — Endocavity CLA D8-2U 1.8-8.2 Adult abdomen, OB/GYN Yes — Yes — Volume CLA DE10-3U 2.0-9.0 OB/GYN, urology Yes — Yes — Volume endocavity CLA * Single-crystal probe technology. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 11 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 SIGNIFICANT FINDINGS 3. Contrast-enhanced ultrasound imaging: We performed a variety of tests on this product, including physical a) The Resona 7 supports the vendor’s UWN+ (Ultra-Wideband testing, a review of product literature/specifications, and asking Non-linear Plus) CEUS software that can be used on several users about their experience with the device. For more details, 2D and volume probes; see the transducer table for more de- see the ECRI’s Testing section of our Evaluation Background on tails. When used with the ultrasound contrast agent Lumason premium GP scanners. (Bracco Diagnostics, Princeton, NJ), contrast enhancement was demonstrated qualitatively within the Doppler flow phan- Performance—Excellent tom, and the degree of signal enhancement met our quantita- The Resona 7 met ECRI’s required performance criteria and offers tive criteria. The scanner offers optional contrast quantifica- several major and minor performance advantages, as listed below. tion software to enhance diagnoses and workflow. Major Advantages b) CEUS improves the ability to assess blood flow and tissue per- 1. Elastography: fusion. It also improves the ability to characterize focal liver tumors and can be used for other applications. For additional a) The Resona 7 has Natural Touch Elastography (strain elas- information regarding ultrasound contrast agents, see our tography) and Sound Touch Elastography (STE; shear-wave article Advances in Diagnostic Ultrasound: Contrast-Enhanced elastography) capabilities on a variety of probes; see the Ultrasound Imaging. transducer table above for more details. STE correctly and reproducibly demonstrated the relative stiffness of the 10 kPa, Minor Advantages 40 kPa, and 60 kPa targets in the phantom. Strain imaging 1. Three-dimensional and four-dimensional imaging: correctly and reproducibly demonstrated the relative stiffness a) The scanner’s 3D and 4D capabilities, which we qualitatively of the 10 kPa and 60 kPa targets, but did not demonstrate the assessed using dedicated volume phantoms, were easy to use 40 kPa target. The scanner has software to quantify elas- and offered rapid data acquisition rates. tography data. b) Three- and four-dimensional imaging can enhance the ability b) Elastography provides tissue stiffness data that enhances to assess both normal and abnormal structures and can the diagnostic capabilities of the modality. Read more about enhance the diagnostic capabilities of the scanner. elastography in our article Advances in Diagnostic Ultra- sound: Elastography. 2. Needle-enhancement mode: 2. F usion imaging and needle navigation: a) iNeedle is available on flat linear-array transducers. Our tests on the L14-5WU probe confirmed the effectiveness of this a) We reviewed product labeling and other information mode to increase the conspicuity of needles in a soft-tissue regarding the scanner’s iFusion and Needle Navigation Guid- phantom. User-adjustable controls include needle angle, ing capabilities. magnification, gain, and single or dual image display. b) Fusion imaging allows users to simultaneously view previ- b) Needle enhancement is used to improve a clinician’s ability to ously acquired ultrasound, CT, MRI, or PET/CT data during identify and localize needles and other devices (e.g., radio-fre- a real-time ultrasound exam. Fusion imaging is used for a quency ablation probes) during ultrasound-guided interven- variety of clinical applications, including to guide sonographic tions. This feature has the potential to reduce the user-depen- localization of a target lesion or area for diagnosis and for dence of performing ultrasound-guided procedures, and to ultrasound-guided interventional procedures. Needle Naviga- improve accuracy of needle placement. tion Guiding is used alone or in combination with iFusion to guide interventional procedures. Read more in our article Ad- vances in Diagnostic Ultrasound: Fusion Ultrasound Imaging. ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 12 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 Safety—Good pler data and facilitate examination processes by reducing the number of parameters that must be adjusted manually. This The Resona 7 met our required safety criteria. feature also has the potential to reduce work-related muscu- Workflow—Good loskeletal disorders (WRMSDs) because fewer user keystrokes The Resona 7 met our required workflow criteria, and demonstrat- are required to optimize data. ed advantages for features that enhance the use of the scanner for 2. Auto-optimization for CDI and PDI: both conventional and advanced applications, as listed below. a) The optional Smart Track control improves suboptimal CDI Major Advantages or PDI data by adjusting the color region of interest (ROI) 1. D ual display of conventional B-mode and CEUS modes and position and angle. This feature is available on flat linear-ar- individually adjustable controls: ray transducers. a) A dual display can be used to simultaneously view conven- b) Effective CDI and PDI auto-optimization features reduce the tional B-mode and contrast-enhanced images in real time. user-dependence of obtaining diagnostically acceptable data There are individual user-adjustable controls for CEUS and and facilitate examination processes by reducing the number conventional B-mode. of parameters that must be adjusted manually. This feature also has the potential to reduce WRMSDs because it requires b) Contrast enhancement can obscure anatomical details that fewer user keystrokes to optimize images. can be visualized on the conventional B-mode image. Having simultaneous display of the conventional B-mode and CEUS Notable Finding data can reduce problems associated with this phenomenon. The Resona 7’s iTouch feature is described in the user manual as a Individual user-adjustable controls allow users to optimize control to optimize the B-mode image based on tissue character- the image quality of each mode. istics. However, it does not actually change the imaging param- 2. D ata import for fusion imaging: eters based on tissue characteristics; instead, the iTouch control simply sets the B-mode gain and TGC levels at a user-selected a) Data can be imported in Digital Imaging and Communications default value. in Medicine (DICOM) format, from a DVD or from a picture archiving and communication system (PACS) via an Ether- Patient Experience—Not Evaluated net connection. Patient experience is not a purchasing factor for these devices. b) Having multiple ways to import data provides flexibility and enhances workflow. Interoperability—Good The Resona 7 met our interoperability criteria, including the ability Minor Advantages to communicate via Ethernet with a hospital information system 1. A uto-optimization control for PW Doppler (optional): (HIS) and PACS. Wi-Fi is available as an option. a) The optional iTouch one-button auto-optimization control Cybersecurity—Good improves suboptimal PW Doppler spectral data by adjusting The Resona 7 met our required cybersecurity criteria. the pulse repetition frequency—which is a key parameter that impacts blood flow detection—and the baseline position to Maintenance—Good optimize the display of data. Additionally, the Smart Track The vendor does not specify the frequency of inspection and feature automatically adjusts the PW Doppler sample volume preventive maintenance procedures, allowing facilities to set their size and position. own frequency. b) Effective PW Doppler auto-optimization features reduce the user-dependence of obtaining diagnostically acceptable Dop- ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 13 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 User Experience—Good 4. Contrast-enhanced ultrasound imaging—The Resona 7 per- formed very well for CEUS studies. Surveyed users confirmed the findings of our Evaluation and did not report having many maintenance problems. Specific features 5. Vendor support is very good for both clinical applications and of the scanner that users commented about include: technical issues. 1. D oppler sensitivity—Users frequently indicated that CDI and PW Doppler provided high sensitivity to blood flow. Cost of Ownership—Good; $137,000 (Estimated) over Seven Years 2. U ser interface is easy to learn and use. 3. A utomated B-mode optimization—The iTouch feature does not perform as well as the auto-optimization controls on other scanners they have used. ESTIMATING THE TYPICAL COST OF OWNERSHIP FOR THE MINDRAY RESONA 7 The costs reported in this table represent typical quotation and purchase costs reported to ECRI’s SELECTplus and PriceGuide databases, respectively. Note that we updated our Cost of Ownership calculation methods in 2019, so some figures in this table may not compare directly with cost figures for products evaluated in prior years. Typical Factor Cost Assumptions Purchase Costs Capital cost $73,000 Based on average quoted price in ECRI’s SELECTplus database. This cost does not include software that may be required for advanced imaging capabilities such as elastography, CEUS, or 3D/4D imaging, or for automated data acquisition and analysis features. Typical accessories $34,000 Four 2D transducers @ $8,500 each. Warranty $0 Five-year warranty that covers accidental probe damage is standard. Clinical staff training $0 Included. Biomedical staff training $0 None required. Infrastructure modifications $0 Assumes facility has an existing exam room and network. Total purchase cost $107,000 — Annual Operational Costs Consumables $580/yr Assumes 60 patients per week (3,100 per year). Acoustic gel from third party (four 5 L containers per case, enough for 340 imaging studies); nine cases per year @ $64 per case. Expected part replacement—averaged throughout life of device $0 None. Service $13,000/yr Annual warranty that covers accidental probe damage after the initial five-year warranty. Annual license fee $0 None required. Average annual operational cost $4,300 $580/yr for years 1-5 (warranty period), $13,580/yr for years 6-7. Estimated Total Cost of Ownership $137,000 Total purchase cost + (annual operational cost × estimated life) (for an estimated life of seven years) ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 14 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
Mindray Resona 7 DISCUSSION OF KEY MANUFACTURER CLAIMS Mindray Claim Category ECRI Perspective Acquisition and software processing of large ZONES of acoustic data cre- Performance ECRI does not agree. ates individual ultrasound image frames 10 times faster than conventional The frame rates of the probes tested were not significantly faster than those of other line-by-line beam forming methods. devices we evaluated. Total Recall Imaging (TRI) allows the user to retrospectively modify numer- Workflow ECRI agrees, but the benefit is not likely significant. ous imaging parameters and optimize clinical information. It eliminates Other devices we evaluated also allow retrospective modification of imaging the need for repeat scanning and improves patient throughput. parameters. RECALLS AND HAZARDS OEM Maintenance A review of Health Devices Alerts records from May 2016 through 1. Standard OEM service options: N/A May 2019 did not identify any alerts related to the Resona 7. 2. Remote monitoring: No 3. Software upgrade and update policy: SERVICE AND MAINTENANCE The following information is provided largely verbatim from a) 5 years of software upgrades/updates included with the the manufacturer. purchase of the system. Adding new functionality may not be free. Software update is free. Warranty b) An update would be correcting a known bug or improving im- Standard warranty terms: 5 years parts and labor age quality on existing transducers or technology. Upgrades are included as long as they are software related. Any hard- Inspection and Preventive Maintenance (IPM) ware that has to be changed or added would be chargeable to 1. I PM frequency: The Resona 7 does not require regular preventa- the customer. tive maintenance. 2. D owntime for IPM: N/A OTHER PURCHASE OPTIONS None specified. In-House/Third-Party Service 1. M anufacturer supports user repair: Yes 2. T raining is optional; typical cost is $3,000/person 3. A vailability of service manual: Yes 4. D edicated test equipment and/or software required: No 5. A vailability of manufacturer assistance: Yes, technical sup- port toll free ©2021 ECRI e clientservices@ecri.org | w www.ecri.org | | 15 ECRI prohibits the reproduction of this report, in whole or in part, except by member institutions, without prior written permission.
About ECRI ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on patient safety, evidence-based medicine, and health technology decision solutions, ECRI is the trusted expert for healthcare leaders and agencies worldwide. The Institute for Safe Medication Practices (ISMP) is an ECRI affiliate. Visit ecri.org and follow @ECRI_Org. e clientservices@ecri.org | w www.ecri.org | ©2021 ECRI. All Rights Reserved. MS3913
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