Technical Publications Vscan Air User Manual GP092020-1EN - English Rev 08 For USA: CAUTION- Investigational device. Limited by United States law to investigational use. Operating Documentation Copyright © 2020 By General Electric Co.
Regulatory requirement Vscan Air ™ Vscan Air is a trademark of GE Healthcare. This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices. This manual is a reference for the following Vscan Air CL probe configurations: Vscan Air CL A1, Vscan Air CL A2, Vscan Air CL A3, Vscan Air CL C1, Vscan Air CL C2, Vscan Air CL C3, Vscan Air CL I1, Vscan Air CL I2 and Vscan Air CL G1. This manual is a reference for all 1.
Revision History Reason for Change REV DATE DD Month YYYY REASON FOR CHANGE Rev 01 24 Dec 2019 Initial MyWorkshop release Rev 02 31 Mar 2020 Activation and Registration Regulatory image, Registered devices, App version info, Appendix section.
REV i-2 DATE DD Month YYYY REASON FOR CHANGE Rev 06 10 Aug 2020 Chapter 1 updated Secion: - Attention - Intended use - Important Safety Considerations - Internet Chapter 2 updated Section: - Overview -> Note - Interference Caution -> Warning - Changing imaging modes - Vscan Air Labels -> Note Chapter 3 updated: - Anker PowerWave wireless charging pad package contents - System overview -> Note - Charging the battery - Supported Mobile Platforms - Display devices - validation - Display device image qual
REV Rev 08 DATE DD Month YYYY 06 Nov 2020 REASON FOR CHANGE Chapter 3: Update: - Pre-requisites - Supported Mobile Platforms - Display device image quality verification - Figure 3-20. Registration Complete - Figure 3-26. Registration Complete Added session- Add security pin (data access pin) - TouchID for quick data access (Biometric authentication) - Change data access pin - Unregister Vscan Air Probe - Unregister Vscan Air app Chapter 4: Update: Figure 4-1. Menu - Figure 4-2.
Please verify that you are using the latest revision of this document. Information pertaining to this document is maintained on ePDM (GE electronic Product Data Management). If you need to know the latest revision, contact your distributor, local GE Sales Representative or in the USA call the GE Ultrasound Clinical Answer Center at 1 800 682 5327 or 1 262 524 5698.
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Regulatory Requirements Conformance Standards The GEHC product families are tested to meet all applicable requirements in relevant EU Directives and European/ International standards. Any changes to accessories, peripheral units or any other part of the device must be approved by the manufacturer: GE Healthcare. Ignoring this advice may compromise the regulatory approvals obtained for the product.
Table i-1: Regulatory Requirements (Continued) Standard/Directive Scope ISO10993-1 Biological evaluation of medical devices EN 300 328 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems ISO 14971 Medical devices — Application of risk management to medical devices IEC* 62304 Medical device software — Software life-cycle processes IEC* 62366-1 Medical devices — Application of usability engineering to medical devices IEC 60601-1-11 Requirements for medi
Certifications • GE Vingmed Ultrasound AS is ISO 13485 certified. Classifications The following classifications are in accordance with the IEC/EN 60601-1: Type and degree of protection against electric shock: • The Vscan Air CL probe has an internal battery which allows the operation during AC power absence. • The AC adapter is Class II. The Vscan Air CL probe is IP67 meaning that it can be submerged in 1m of water for 30 minutes. The AC adapter is IP20 meaning it must be limited to indoor use.
Country Specific Approval Importer Information Turkey Importer information for Turkey does not have the font and font size normally used in the manual. USA • FCC ID: YOM-VSCANAIR • IC: 9136A-VSCANAIR Canada Steps to access FCC ID and IC ID 1. To access FCC ID and IC ID information, select Menu icon on Vscan Air app. 2. Press About and select Regulatory.
i-10 Vscan Air – User Manual Direction GP092020-1EN Rev 08
Table of Contents Conformance Standards - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-6 Certifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8 Classifications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8 Class II Equipment - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - i-8 Type BF Applied part - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Diagnostic information- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Explosion hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-6 Electrical hazard - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Electrical safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 External connection
Chapter 5 — Using Vscan Air CL Display Features Left panel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2 Scanning General scanning recommendations- - - - - - - - - - - - - - - - - - - - - - - - - - 5-4 Measurements Taking measurements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-43 Review and recall of stored data Review Current Exam - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-46 Export data - - - - - - -
Appendices Statements on the safety of ultrasound - - - - - - - - - - - - - - - - - - - - - - - 7-15 Measurement accuracy Measurement accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-16 Indications Reference Guide Disclaimer - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-18 Curved Array (Deep scanning) Transducer - - - - - - - - - - - - - - - - - - - - 7-18 Linear Array (Shallow scanning) Transducer - - - - - - - - - - - - - - - - - -
Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-11 ‘Contact Information’ on page 1-13 Vscan Air – User Manual Direction GP092020-1EN Rev 08 1-1
Introduction Overview Attention This manual contains necessary and sufficient information to operate the ultrasound system safely. Read and understand all instructions in the User Manual before attempting to use the ultrasound system. Periodically review the procedures for operation and safety precautions. Disregarding information on safety is considered abnormal use. Not all features or products described in this document may be available or cleared for sale in all markets.
Overview Documentation (continued) • The Service Manual (ENGLISH ONLY) supplies block diagrams, lists of spare parts, descriptions, adjustment instructions, or similar information which helps qualified technical personnel in repairing those parts of the system which have been defined as repairable. • Medical Ultrasound Safety publication from American Institute of Ultrasound in Medicine (AIUM) (ENGLISH ONLY).
Introduction Documentation (continued) The table below lists the Vscan Air CL configurations covered by this manual: Table 1-1: Item NOTE: Vscan Air CL configurations Vscan Air CL Part number REF 1 GP000150 Vscan Air CL A1 2 GP000151 Vscan Air CL A2 3 GP000152 Vscan Air CL A3 4 GP000153 Vscan Air CL C1 5 GP000154 Vscan Air CL C2 6 GP000155 Vscan Air CL C3 7 GP000156 Vscan Air CL I1 8 GP000157 Vscan Air CL I2 9 GP000158 Vscan Air CL G1 The Vscan Air CL probe comes with differe
Overview Naming conventions The following naming conventions are used throughout the user manual: • Vscan Air CL – refers to the Vscan Air probe. • Vscan Air for iOS – Vscan Air app for iOS devices. • Vscan Air for Android – Vscan Air app for Android devices. The term ‘Vscan Air app’ has been used to refer to the software application/app in a generic way.
Introduction Wireless Description Wireless communication utilizes the 2.4GHz and 5GHz (UNII-1 and UNII-3) bands supporting the IEEE 802.11a, IEEE 802.11b, IEEE 802.11g and IEEE 802.11n protocols. The wireless module supports bandwidths of 20MHz and 40MHz. The preferred frequency is 5GHz, with bandwidth 40MHz. Table 1-2: Wireless Description 1 Wireless network protocols supported IEEE 802.11a/b/g/n 2 Frequency bands of transmission / reception 2.
Overview Safety Read and understand all instructions in the User's Manual before attempting to use the ultrasound unit. User Manual is available in electronic form and is easy to reach via the App or via web. Periodically review the procedures for operation and safety precautions. Intended use Vscan Air is a software application on a mobile phone or tablet to be used with a Vscan Air probe.
Introduction Indications for use (continued) With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (adult and pediatric, 40 kg and above), vascular/peripheral vascular, musculoskeletal (conventional), pediatrics, interventional guidance (includes free hand needle/ catheter placement, fluid drainage, nerve block and biopsy).
Overview Clinical application not cleared for use in Japan NOTE: Vscan Air diagnostic ultrasound system does not hold regulatory clearance in Japan for Ophthalmic use. Intended users The list of the potential users includes but is not limited to (based on title/geographical location): physicians, sonographers, medical healthcare technicians, paramedics, nurses, nurse practitioner, midwives, midwife practitioner, physiotherapists, physician assistants, medical students.
Introduction CAUTION The operator must read and understand the user manual. Contact GEHC sales representative for product training assistance and visit the Vscan Air web portal for reference materials. Prescription Device For USA only: CAUTION 1-10 Federal law restricts this device to sale by or on the order of a physician or other authorized licensed healthcare practitioner.
Warnings Warnings Important Safety Considerations To prevent damage of the equipment or injury to yourself or others, read the following safety warnings before using Vscan Air. WARNING • Vscan Air CL is a precision instrument. Handle Vscan Air CL and its accessories with care. • Do not attempt to disassemble or alter any part of the unit including the Vscan Air CL, the battery, the AC adapter and accessories. Disassembly or modification may result in electrical shock.
Introduction Important Safety Considerations (continued) WARNING • Keep good hand contact with Vscan Air CL during scanning to avoid heating up of the unit and termination of scan due to built-in temperature limits. • Disconnect the AC adapter and the wireless charger when not in use to avoid fire hazard. • Keep the AC adapter and the wireless charger dry. Failure to observe this precaution may result in fire and electric shock.
Contact Information Contact Information Contacting GEHC Ultrasound For additional information or assistance, please contact your local distributor or the appropriate support resource listed on the following pages: INTERNET http://www.gehealthcare.com http://www3.gehealthcare.com/en/Products/Categories/ Ultrasound/Ultrasound_Probes https://handheldultrasound.gehealthcare.com/ Vscan Air web portal: https://vscanair.
Introduction Contacting GEHC Ultrasound (continued) Placing an Order To order accessories, supplies, or service parts in the United States, call the GEHC Contact Center. TEL: (1) 800-558-5102 In other locations, contact your local Applications, Sales, or Service Representative. NOTE: Electronic ordering will be up running in some regions. Global ultrasound support center phone numbers For countries not listed in the tables below, please contact the local distributor.
Contact Information Table 1-5: Americas (Continued) USA TEL: (1) 800-437-1171 FAX: (1) 414-721-3865 For USA only: when contacting GE CARES you will have to provide your system ID. If system ID is unknown, please give the Temporary System ID “Vscan Air” to be properly routed for support.
Introduction Table 1-7: AUSTRIA Europe TEL: (+43) 1 97272 0 FAX: (+43) 1 97272 2222 BELGIUM & LUXEMBURG TEL: (+32) 2 719 7204 FAX: (+32) 2 719 7205 CZECH REPUBLIC TEL: (+420) 224 446 162 FAX: (+420) 224 446 161 DENMARK TEL: (+45) 43 295 400 FAX: (+45) 43 295 399 ESTONIA & FINLAND TEL: (+358) 10 39 48 220 FAX: (+358) 10 39 48 221 FRANCE TEL: (+33) 1 34 49 52 70 FAX: (+33) 13 44 95 202 GERMANY TEL: (+49) 212-28 02-0 FAX: (+49) 212-28 02-380 GREECE TEL: (+30) 210 8930600 FAX: (+30) 210 9625931
Contact Information Table 1-7: Europe (Continued) HUNGARY TEL: (+36) 23 410 314 FAX: (+36) 23 410 390 IRELAND NORTHERN IRELAND TEL: (+44) 028 90229900 REPUBLIC OF IRELAND TEL: 1800 460 550 FAX: (+353) 1 686 5327 ITALY TEL: (+39) 02 2600 1111 FAX: (+39) 02 2600 1417 KAZAKHSTAN LUXEMBORG T +7 727 3560020 See Belgium.
Introduction Table 1-7: POLAND Europe (Continued) TEL: (+48) 22 330 83 00 FAX: (+48) 22 330 83 83 PORTUGAL TEL: (+351) 21 425 1300 FAX: (+351) 21 425 1343 RUSSIA TEL: (+7) 4957 396931 FAX: (+7) 4957 396932 SPAIN TEL: (+34) 91 663 2500 FAX: (+34) 91 663 2501 SWEDEN TEL: (+46) 08 559 500 10 FAX: (+46) 08 559 500 15 Service Center (+46) 020-120 14 36 SWITZERLAND TEL: (+41) 1 809 92 92 FAX: (+41) 1 809 92 22 TURKEY TEL: +90 212 398 07 00 FAX: +90 212 284 67 00 UNITED ARAB EMIRATES (UAE) 1-18 TEL
Contact Information Table 1-7: UNITED KINGDOM Europe (Continued) TEL: (+44) 1494 544000 FAX: (+44) 1707 289742 For all other European countries not listed, please contact your local GEHC distributor or the appropriate support resource listed on www.gehealthcare.com.
Introduction 1-20 Vscan Air – User Manual Direction GP092020-1EN Rev 08
Chapter 2 Safety Contents: ‘Introduction’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Important safety considerations’ on page 2-5 ‘Maximum probe temperature’ on page 2-23 ‘Device labels and symbols’ on page 2-24 Vscan Air – User Manual Direction GP092020-1EN Rev 08 2-1
Safety Introduction Overview This chapter describes the important safety measures which should be taken before operating the Vscan Air ultrasound system. Procedures for simple care and maintenance of the Vscan Air CL probe are also described. Various levels of safety precautions may be found on the equipment, and different levels of severity are identified by one of the following icons that precede precautionary statements in the text.
Owner responsibility Owner responsibility Overview It is the responsibility of the owner to ensure that anyone operating Vscan Air reads and understands this section of the manual. However, there is no representation that the act of reading this manual renders the reader qualified to operate, inspect, test, align, calibrate, troubleshoot, repair or modify the system. The owner should make certain that only properly trained, fully-qualified service personnel undertake maintenance of the equipment.
Safety Notice against user modification Never modify this product, including system components, cables, and so on. User modification may cause safety hazards and degradation in system performance. All modification must be done by a GEHC qualified person. Software upgrade following GEHC recommendations can be done by the user.
Important safety considerations Important safety considerations Overview This section includes considerations for the following: • Patient safety • Personnel and equipment safety The information contained in this section is intended to familiarize the user with the hazards associated with the use of Vscan Air, and to alert them to the extent to which injury and damage may occur if the precautions are not observed.
Safety Diagnostic information (continued) The user should be aware of the product specifications and of the device accuracy and stability limitations. These limitations must be considered before making any decision based on quantitative values. If in doubt, the nearest GEHC ultrasound service office should be consulted. Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details in the image.
Important safety considerations Electrical hazard WARNING NOTE: The internal circuits of the AC adapter use high voltages, capable of causing serious injury or death by electrical shock. Any rest energy within Vscan Air CL or their components will be below 60 V DC or 2 mJ. Electrical safety Device classifications Vscan Air CL probe is an internally powered device, type BF. The AC adapter is Class II.
Safety Allergic reactions to latex-containing medical devices Due to reports of severe allergic reactions to medical devices containing latex (natural rubber), the FDA advises healthcare professionals to identify latex-sensitive patients, and be prepared to treat allergic reactions promptly. Latex is a component of many medical devices, including surgical and examination gloves, catheters, intubation tubes, anesthesia masks, and dental dams.
Important safety considerations Electromagnetic Compatibility (EMC) (continued) Radiated or conducted electromagnetic signals can cause distortion, degradation, or artifacts in the ultrasound image which may impair the ultrasound unit’s essential performance (see ‘Electrical safety’ on page 2-7). There is no guarantee that interference will not occur in a particular installation.
Safety Electromagnetic Compatibility (EMC) (continued) Any electrical device can unintentionally emit electromagnetic waves. However, minimum device separation distances cannot be calculated for such unspecified electromagnetic radiation. When the ultrasound unit is used adjacent to or in close proximity to other equipment the user should be attentive to unexpected device behavior which may be caused by such electromagnetic radiation.
Important safety considerations FCC compliance statements CAUTION Any changes or modifications not expressly approved by the party Responsible for compliance could void the user's authority to operate this Equipment. Part 15B compliance statements for digital devices: NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
Safety FCC compliance statements (continued) This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. NOTE: Vscan Air CL is a handheld ultrasound wireless probe with dual transducer. Convex and Linear side of the probe is intended to be placed on human body for ultrasound scanning.
Important safety considerations Electromagnetic immunity Table 2-2: Electromagnetic immunity (Part 1) Guidance and manufacturer’s declaration – electromagnetic immunity. The Vscan Air CL probe is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Air CL should assure that it is used in such an environment.
Safety Table 2-2: Electromagnetic immunity (Part 1) (Continued) Guidance and manufacturer’s declaration – electromagnetic immunity. The Vscan Air CL probe is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Air CL should assure that it is used in such an environment.
Important safety considerations Table 2-3: Electromagnetic immunity (Part 2) Guidance and manufacturer’s declaration – electromagnetic immunity – for all medical electrical equipment and medical electrical systems that not life-supporting The Vscan Air CL probe is intended for use in the electromagnetic environment below. The customer or the user of the Vscan Air CL should assure that it is used in such an environment.
Safety Essential Performance The essential performance of the Vscan Air CL is: • The ability to display physiological images as input for diagnosis by qualified and trained healthcare professionals. • The ability to display quantified data as input for diagnosis by qualified and trained healthcare professionals. • The display of ultrasound indicies as aid for safe use of the Vscan Air CL.
Important safety considerations Ispta The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum limit of Ispta is 720 mW/cm2 as set by the FDA guidance of June 27, 2019 for diagnostic ultrasound systems and transducers. Acoustic output and display on Vscan Air MI and TI values are displayed on the scanning screen. The display resolution of MI and TI is 0.1.
Safety System controls affecting acoustic output The operator controls that directly affect the acoustic output are discussed in the Acoustic Output Data Tables. These tables show the highest possible acoustic intensity for a given mode, obtainable only when the maximum combination of control settings is selected. Most settings result in a lower output.
Important safety considerations Sensitive tissues Particular care should be taken to reduce the risk of thermal hazard when exposing the following to diagnostic ultrasound: - an embryo less than eight weeks after conception; - the head, brain or spine of any fetus or neonate; - an eye (in a subject of any age).
Safety Table 2-6: Recommended maximum scanning times (Neonatal- Transcranial and Spinal scanning) Neonatal- Transcranial and Spinal scanning TI time Neonatal - General and Cardiac imaging TI time 0.0–0.7 Unlimited 0.0–0.7 Unlimited 0.7–1.0 < 60 min 0.7–1.0 Unlimited 1.0–1.5 < 30 min 1.0-1.5 120 min 1.5–2.0 < 15 min 1.5-2.0 60 min 2.0–2.5 < 4 min 2.0-2.5 15 min 2.5–3.0 < 1 min 2.5-3.0 4 min 3.0-4.0 Scanning of the central nervous system is not recommended 3.0-4.
Important safety considerations ALARA Ultrasound procedures should be performed using output levels and exposure times As Low As Reasonably Achievable (ALARA) while acquiring clinical information. During a diagnostic ultrasound examination, high frequency sound penetrates and interacts with tissue in and around the area of anatomy to be imaged. Only a small portion of the sound energy is reflected back to the probe for use in constructing the image while the remainder is dissipated within the tissue.
Safety Training During each ultrasound examination the user is expected to weigh the medical benefit of the diagnostic information that would be obtained against the risk of potential harmful effects. Once a diagnostic image is achieved, prolonging the exposure cannot be justified. It is recommended that all users receive proper training in applications before performing them in a clinical setting.
Maximum probe temperature Maximum probe temperature Maximum probe temperature The table below indicates the maximum probe temperature. Table 2-7: Maximum Vscan Air CL temperature Max Temp (°C) (Simulated use) Probe Max Temp (°C) (Still air) Vscan Air CL – Curved array transducer (for deep scanning) 38.7 44.5 Vscan Air CL – Linear array transducer (for shallow scanning) 37.7 41.9 NOTE: Measurement uncertainty and probe variation: 2.0 °C.
Safety Device labels and symbols Vscan Air labels 1. Laser printed label for Vscan Air CL probe – US Version 2. Laser printed label for Vscan Air CL probe – EU Version Figure 2-2. Vscan Air CL probe rating label versions 1. Vscan Air for Android rating label 2. Vscan Air for iOS rating label Figure 2-3.
Device labels and symbols Vscan Air labels (continued) Figure 2-4. NOTE: Adapter label The labels shown in Figure 2-2, Figure 2-3, and Figure 2-4 are samples. The label content will vary based on country requirements and AC adapter configuration. Figure 2-5.
Safety Vscan Air labels (continued) The following table describes the purpose of safety labels and other important information provided on the equipment. Table 2-8: Label 2-26 Label Icons Purpose Location Standard Indicates that the product is in compliance with all relevant European Directives and under surveillance by Notified Body 0123.
Device labels and symbols Table 2-8: Label Label Icons Purpose Location Standard Manufacturing date (year-month) Vscan Air CL probe Vscan Air app ISO 7000-2497 Brand and model identifier. Vscan Air CL probe Vscan Air app ISO 7000-2493 Serial number Vscan Air CL probe ISO 7000-2498 Unique Device Identification (UDI). Every system has a unique marking for identification. Scan or enter the UDI information into the patient health record according to governing laws.
Safety Explanation of the Pollution control label for China The following product pollution control information is provided according to SJ/T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products Table 2-9: Component Name Hazardous substances Hazardous Substances' Name Pb Hg Cd Cr6+ PBB PBDE Probe & Cable X O O O O O Main unit O O O O O O O: Indicates that hazardous substance contained in all of the homogeneous materials for this part is
Chapter 3 Preparing Vscan Air CL for Use Contents: ‘Package contents’ on page 3-2 ‘Environmental requirements’ on page 3-7 ‘System description’ on page 3-9 ‘Accessories’ on page 3-12 ‘Vscan Air CL Battery’ on page 3-13 ‘Initial use’ on page 3-18 Vscan Air – User Manual Direction GP092020-1EN Rev 08 3-1
Preparing Vscan Air CL for Use Package contents Vscan Air CL shipment box contents Vscan Air CL product box Make sure all items listed below are included in the package. 1. 2. 3. 4. Vscan Air CL Quick Start Guide Vscan Air CL probe Product box Product Box with Protective Case Figure 3-1. NOTE: 3-2 5. Protective case 6. Product Box Inlay 7.
Package contents Anker PowerWave wireless charging pad package contents 1. 2. 3. 4. 5. 6. Package contents with front and back cover Instruction booklet Package contents with PowerWave Pad and USB cable Unboxing of the Contents USB cable (1.2m) Anker PowerWave charging pad Figure 3-2.
Preparing Vscan Air CL for Use How to charge the Vscan Air CL 1. Plug one end of the USB cable into the wireless charging Pad and the other into the AC adapter. 2. Connect the AC adapter into the wall outlet.
Package contents How to charge the Vscan Air CL (continued) 3. Place the Vscan Air CL on the charging pad with the GE logo up. Ensure the probe is centred on the charging pad. 4. The Vscan Air CL lights up and starts charging.
Preparing Vscan Air CL for Use How to charge the Vscan Air CL (continued) 5. Vscan Air CL gets wirelessly charged with the Anker PowerWave charging pad. Yellow light on both LEDs indicates the Vscan Air CL is charging. Green light on both LEDs indicates the Vscan Air CL is fully charged 90-100% (see ‘Vscan Air CL LED indication’ on page 3-16).
Environmental requirements Environmental requirements Environmental requirements for Vscan Air CL Table 3-1: Environmental requirements Description Operational Non operational Storage and transport Temperature 0°C to + 35°C - 40°C to + 70°C - 40°C to + 70°C Humidity 10–90% 10–95% 10–95% Air pressure 54 kPa to 106 kPa 50 kPa to 106 kPa 50 kPa to 106 kPa Transient operating conditions NOTE: NOTE: Permissible transient environmental operating conditions: • Temperature range of -20 to +50
Preparing Vscan Air CL for Use Acclimatization time Allow the Vscan Air CL to acclimate for approximately 10 minutes, if stored at temperatures ranging from -20°C to +50°C. Allow the Vscan Air CL to acclimate for approximately 30 minutes, if stored at temperatures outside the transient environmental operating conditions -20°C to +50°C.
System description System description System overview The Vscan Air CL is a dual headed battery-operated ultrasound device. The Vscan Air CL has a linear array on one side, and a curved array on the opposite side. It generates a beam of ultrasound that is transmitted into the subject's body. The reflection of this beam is transformed into an image that is wirelessly transmitted to a phone or a tablet and displayed via the installed Vscan Air app.
Preparing Vscan Air CL for Use Display screens Connection and probe battery status • No out-line of the probe and no battery charge indication NOT CONNECTED TO PROBE • White out-line of the probe and battery charge indication CONNECTED TO PROBE 1. White out-line of the probe 2.
System description Display screens (continued) Figure 3-4. Black/white imaging mode (B-mode) Curved array (deep scanning) transducer 1. Selected preset 2. Exam number 3. Focus marker 4. Depth 5. Store 6. Freeze 7. Color flow 8. Center line marker 9. Image orientation marker 10. Vscan Air CL battery status indicator 11. Mechanical Index (MI) 12. Thermal Index (TI) Vscan Air – User Manual Direction GP092020-1EN Rev 08 Linear array (shallow scanning) transducer 1. Selected preset 2. Exam number 3.
Preparing Vscan Air CL for Use Accessories Optional accessories Table 3-2: Accessory International AC Adapter Figure AC Adapter - Type C AC Adapter - Type G AC Adapter - Type A AC Adapter - Type I NOTE: 3-12 Details about types of AC power plugs are included in ‘Power plugs’ on page 3-14 Vscan Air – User Manual Direction GP092020-1EN Rev 08
Vscan Air CL Battery Vscan Air CL Battery Battery The Vscan Air CL probe is powered by a Li ION battery. The battery is not fully charged prior to shipment. To maximize time of use, it is recommended to recharge the battery before use for at least 1.5 hours. Establish a routine for charging the battery to maximize device availability.
Preparing Vscan Air CL for Use Power plugs The AC adapter power plug requirement for the country or region is shipped together with the Vscan Air CL according to purchase order. Figure 3-5. 1. Type A - USA, Canada, Japan, Taiwan, Mexico 2. Type C - Europe, Turkey, Korea, Indonesia, Philippines, Thailand, Vietnam, Israel, Russia, Brazil, Chile, Egypt Power plugs 3. Type I - Australia, New Zealand, China, Argentina 4.
Vscan Air CL Battery Battery level indicator The Vscan Air CL battery level indicator icon is displayed on the screen when Vscan Air CL is connected to the Vscan Air App. The following icons are displayed. Table 3-4: Icon Battery level indicator Description Battery charged 90-100% Battery charged 80-90% Battery charged 65-80% Battery charged 50-65% Battery charged 35-50% Battery charged 25-35% Battery charged 15-25%. Prepare to recharge the battery. Battery charged 8-15%.
Preparing Vscan Air CL for Use Vscan Air CL LED indication 1. 2. 3. 4. 5. 6. 7. 8. 9. Booting Searching Display found Connected Active array Figure 3-6. Charging Fully charged Occupied Error LED states - A blinking white light switching between Vscan Air CL ends indicates the Vscan Air CL is booting. - A blinking white light on both LEDs indicates the Vscan Air CL is ON and searching for Vscan Air App.
Vscan Air CL Battery Battery specifications Table 3-5: Battery specification Item Specification Charging time starting at 10%, charging to 90% capacity using a new battery at room temperature 20 to 25 deg C 75 minutes Capacity About 1 hour while continuously scanning Lifetime At least 500 charges In order to get maximum charging capacity with your Vscan Air CL battery, you should initially allow the battery to be fully charged and then fully discharged at least three times.
Preparing Vscan Air CL for Use Initial use Pre-requisites Vscan Air app requires the display device to have at least 700MB of free memory when starting. Supported Mobile Platforms • Operating system options - Android phones and tablets with OS version 9, 10 or 11, device with 0x64 ARM based CPU architecture and 64-bit Kernel, Android open GL ES 3.
Initial use Display devices - validation The Vscan Air App for iOS has been validated for the following display devices: • iPad • iPad mini • iPhone 11 The Vscan Air App for Android has been validated for the following display devices: • Samsung Galaxy S6 • Samsung Galaxy S10 • Samsung Galaxy Tablet S6 • Samsung Galaxy S20 • Google Pixel 4 Please visit the Vscan Air web page for additional information on validated display devices.
Preparing Vscan Air CL for Use Display device image quality verification (continued) There are example reference images available in the ‘Preview mode’. These images can be used to adjust the brightness level of the device, so that a full range of grey scale level is visible. Recommended example images: Abdominal preset on Curved and MSK preset on Linear transducer. Figure 3-8. Figure 3-9.
Initial use Display device image quality verification (continued) Figure 3-10. MSK preset with linear It is also recommended to turn off adaptive brightness and display filters. Power ON/OFF To power on the Vscan Air the first time the first step is to start a charging cycle. Place the Vscan Air CL probe on the wireless charging pad as shown in ‘How to charge the Vscan Air CL’ on page 3-4 To turn ON the Vscan Air CL, press and hold the power button for 1 second.
Preparing Vscan Air CL for Use Activation and Registration Each Vscan Air device needs to be registered to a user account on the Vscan Air product registration server to be activated and ready for use. The account will hold the user contact information in addition to information on devices registered to the account. First time registration Vscan Air app installation 1. Power ON the display device. 2. Download the Vscan Air app via Google Play Store or Apple App Store depending on your display device OS. 3.
Initial use First time registration (continued) 3. Select Create. Figure 3-12. Register the Vscan Air app 4. Turn on Vscan Air CL. Figure 3-13. NOTE: Search for Vscan Air CL The Vscan Air probe will not be able to connect to the Vscan Air App if the Android or iOS mobile device is in 'Flight mode'.
Preparing Vscan Air CL for Use First time registration (continued) 5. Wait for initialization of Vscan Air CL. Figure 3-14. Initialization of Vscan Air CL 6. Press the power button on Vscan Air CL to connect to the Vscan Air app. Figure 3-15.
Initial use First time registration (continued) 7. Once Vscan Air CL is found, select “Continue registration”. Figure 3-16. Vscan Air CL Detected 8. Enter the required information. 9. Confirm that given information is correct. 10. Check desired options to either participate in collaborative GEHC activities or to receive special offers and promotions. 11. Press Submit. Figure 3-17.
Preparing Vscan Air CL for Use First time registration (continued) 12. An email is sent to your email address to validate the Vscan Air user account. Figure 3-18. NOTE: Email validation Please check your spam folder if not receiving the email for validating your user account. 13. Click the link in the email to validate the Vsacn Air user account. 14. Confirm registration details. Figure 3-19.
Initial use First time registration (continued) 15. Registration is complete. Security PIN can be set for secure data access by selecting 'Add security PIN' or proceed to scanning by selecting 'Start scanning’. Figure 3-20. Registration Complete 16. To add a security PIN code after completing Vscan Air registration, See ‘Add security PIN (data access PIN)’ on page 3-36 for more information. 17. The Vscan Air CL is now connected to the app. Figure 3-21.
Preparing Vscan Air CL for Use First time registration (continued) NOTE: When the Wi-Fi connection to the paired probe is unexpectedly lost, the Vscan Air App shows warning message as 'Lost connection to Probe' (see the Figure 3-22 below ). Figure 3-22.
Initial use New Vscan Air app Registration using an Existing Account Use the below steps to register a new Vscan Air app on another display device with your existing Vscan Air account. 1. Press Register to start registration. Figure 3-23. NOTE: Welcome Screen The app can be explored by selecting ‘Preview’. In this mode, scanning is disabled. 2. Choose Connect to an existing account option and enter the email address and password for your existing Vscan Air account. 3. Press Connect. Figure 3-24.
Preparing Vscan Air CL for Use New Vscan Air app Registration using an Existing Account (continued) 4. Confirm that registration details are correct or edit if incorrect. Figure 3-25. Registration Confirmed 5. Registration is complete. Security PIN can be set for secure data access by selecting 'Add security PIN' or proceed to scanning by selecting 'Start scanning’.. Figure 3-26. Registration Complete 6.
Initial use New Vscan Air CL probe registration using existing account 1. Open Vscan Air App. 2. Select Add a new probe. Figure 3-27. Search for Vscan Air CL probe 3. If not already turned on, turn on Vscan Air CL probe now. Figure 3-28.
Preparing Vscan Air CL for Use New Vscan Air CL probe registration using existing account (continued) 4. Wait for initialization of Vscan Air CL. Figure 3-29. Initialization of Vscan Air CL 5. Press the power button on Vscan Air CL to connect to the Vscan Air app. Figure 3-30. NOTE: 3-32 Connect to Display When Vscan Air CL is connected to an iOS display device, other Wi-Fi connections will be disconnected.
Initial use New Vscan Air CL probe registration using existing account (continued) 6. Once Vscan Air CL is found, press “Continue registration' and ‘Connect’ to an existing Vscan Air user account. Figure 3-31. Vscan Air CL Detected 7. Enter the email address and password to your existing Vscan Air account. Press Connect. Figure 3-32.
Preparing Vscan Air CL for Use New Vscan Air CL probe registration using existing account (continued) 8. Confirm that registration details are correct or edit if incorrect. 3-34 Figure 3-33. Confirm Registration Figure 3-34.
Initial use New Vscan Air CL probe registration using existing account (continued) 9. Registration is complete. Press Start scanning to begin using your Vscan Air CL device. Figure 3-35. Vscan Air CL activation 10. When the scanning is over switch off the probe. The Vscan Air app on screen displays the message 'Probe is shutting down". Figure 3-36.
Preparing Vscan Air CL for Use Security Exam Information/Patient Information can be protected by enabling a data access PIN. Biometric authentication will if additionally enabled replace the need to enter the data access PIN. • To enable a data access PIN, See ‘Ask for data access pin’ on page 4-25 for more information. • To additionally enable biometric authentication, See ‘TouchID for quick data access (Biometric authentication)’ on page 3-38 for more information.
Initial use Add security PIN (data access PIN) (continued) 2. Enter a new 6 digit PIN in the field on the “Set up data access PIN” screen and Press Next button. Figure 3-38. NOTE: Enter data access PIN Please make sure to use a strong PIN and avoid using PIN codes that are easy to guess. 3. Re-enter the PIN on the “Confirm data access PIN” screen and Press Save button. After successful set up of data access PIN, application takes you to the Security screen. Figure 3-39.
Preparing Vscan Air CL for Use TouchID for quick data access (Biometric authentication) To enable biometric authentication for quick data access, See ‘TouchID for quick data access (Biometric authentication)’ on page 4-27 for more information. Change data access PIN To change the data access PIN, See ‘Change data access PIN’ on page 3-38 for more information. Multi Vscan Air probes detection When a Vscan Air CL probe is not detected near the display device, the search is on continuously.
Initial use Precautions CAUTION If the display device storage space is less than 700Mb, an error message is displayed. NOTE: Scanning does not start if the Vscan Air CL probe is not connected to a Vscan Air app. NOTE: The Vscan Air probe will not be able to connect to the Vscan Air App if the Android or iOS mobile device is in 'Flight mode'. NOTE: If using ‘Hotspot’, Wi-Fi will not be available for connecting to Vscan Air CL.
Preparing Vscan Air CL for Use Unregister Vscan Air Probe To Unregister Vscan Air Probe, follow the procedure below: 1. Press Menu -> About -> Registered devices Figure 3-40. Registered devices 2. Press Unregister button on “Connected probe” tab on Registered devices screen to Unregister Vscan Air Probe. Figure 3-41.
Initial use Unregister Vscan Air app To Unregister Vscan Air app, follow the procedure below: 1. Press Menu -> About -> Registered devices Figure 3-42. Registered devices 2. Press Unregister button on “App on this device” tab on Registered devices screen to Unregister Vscan Air app. Figure 3-43.
Preparing Vscan Air CL for Use Unregister Vscan Air app (continued) 3. After selecting Unregister button, the below message appears. Press Proceed button. Figure 3-44. Unregister app warning 4. Press Erase button on Confirmation screen. On selecting the Erase button, the app is unregistered from the display device and all the patient data is erased. Figure 3-45.
Chapter 4 Vscan Air Configuration (for iOS and Android) Contents: ‘Configuration’ on page 4-2 ‘Support’ on page 4-31 ‘Diagnostics’ on page 4-32 ‘About’ on page 4-34 Vscan Air – User Manual Direction GP092020-1EN Rev 08 4-1
Vscan Air Configuration (for iOS and Android) Configuration The following functions are available under the main menu. 1. Configuration 2. Support 3. Diagnostics 4. About Figure 4-1.
Configuration Configuration To adjust the scan settings, tap the Menu icon. If the preset panel is displayed, select Menu at the top to access the settings panel. Figure 4-2.
Vscan Air Configuration (for iOS and Android) Configuration (continued) • Centerline Marker (see ‘Configuration’ on page 4-3) - Tap the ON/OFF toggle switch to turn ON or OFF the Centerline Marker. When turned ON, Vscan Air app displays the Centerline Marker during black and white, color imaging, in Freeze mode and on recalled images and videos. Figure 4-3. NOTE: Configure the display device with an adequate 'screen-save' timeout.
Configuration Configuration (continued) • Time Gain Compensation (TGC) Control (see ‘Configuration’ on page 4-3) - Tap the ON/OFF toggle switch to turn ON or OFF TGC controls. When TGC is ON, you can adjust the black and white image via the TGC controls on the scan screen. NOTE: For adjustment up to 6 TGC controls are available in portrait or landscape layouts. NOTE: The active gain control is disabled as long as the TGC controls are active.
Vscan Air Configuration (for iOS and Android) Configuration (continued) • Video duration • Press Video duration - The video duration is related to the number of seconds of scan data that is available in the buffer after freezing the image. • Tap on the desired value to set the buffer size. Figure 4-5. • Probe Button Action • Press Probe Button Action. • Tap to choose either Freeze or Save or Off to configure with no action with the Probe button press. Figure 4-6.
Configuration Configuration (continued) • Preview Mode (see ‘Configuration’ on page 4-3) - Tap the ON/OFF toggle switch to turn ON or OFF the preview mode. Press OK if you wish to use the preview mode. Figure 4-8.
Vscan Air Configuration (for iOS and Android) Configuration (continued) • Store binary image data (see ‘Configuration’ on page 4-3) - Tap the ON/OFF toggle switch to turn ON or OFF the binary image data. When turned ON, a pop-up message displays - “Binary image data storage is now enabled and unprocessed data will be stored together with video clips. This uses some additional storage space. Binary image data is useful for research and development in collaboration with GEHC. Figure 4-9.
Configuration DICOM Client 1. Follow the procedure below to configure DICOM Client. Press Menu -> Configuration -> DICOM Client. Figure 4-11. DICOM Client 2. Specify or update the default values of DICOM Client (Vscan Air) information in the respective fields on DICOM Client screen to establish communication with DICOM servers. Figure 4-12.
Vscan Air Configuration (for iOS and Android) Server Settings Allows to configure the Modality Worklist Server, DICOM Image Server, Network Shared Folder. Modality Worklist Server - Retrieves patient and intended study information. DICOM Image Server - Remote store location for videos/ images. Network Shared Folder - Share Images/Videos to the desired path in a PC. Configure Modality Worklist Server Follow the procedure below to configure a new Modality Worklist Server. 1.
Configuration Configure Modality Worklist Server (continued) 2. Press Add Server in “Server Settings” screen. Figure 4-14. Add Server 3. In “Add New Server” screen, select “Modality Worklist Server” from the drop down list of “Server Type” and enter the configuration information in the respective fields to add Modality Worklist Server. If Modality Worklist Server is of Secure Dicom (TLS communication), select the check box “Secure Dicom”. See ‘Secure Dicom’ on page 5-61 for more information.
Vscan Air Configuration (for iOS and Android) Configure Modality Worklist Server (continued) 4. Press “Verify Server” to verify communication with the Modality Worklist Server. “Verify server succeed” pop-up message displays if the communication with the Worklist Server is ok. Press OK and then Press “Add” to add the Modality Worklist Server. If communication fails, check the server settings and make necessary corrections. Figure 4-16.
Configuration Configure Modality Worklist Server (continued) 5. Once the Modality Worklist Server is added, the server name will be available under Server Settings. If this is the first MWL server that is added, it will be the favorite server. If there are more than one MWL/RIS server then one of them has to be chosen as a favorite server. To select a MWL server as a favorite, tap on the respective star mark and press YES on the pop-up message screen. Figure 4-17.
Vscan Air Configuration (for iOS and Android) Configure Dicom Image Server Follow the procedure below to configure a new Dicom Image Server. 1. Press Menu -> Configuration -> Server Settings. Figure 4-18. Server Settings 2. Press Add Server in “Server Settings” screen. Figure 4-19.
Configuration Configure Dicom Image Server (continued) 3. In “Add New Server” screen, select “Dicom Image Server” from the drop down list of “Server Type” and enter the configuration information in the respective fields to add Dicom Image Server. If Dicom Image Server is of Secure Dicom (TLS communication), select the check box “Secure Dicom”. See ‘Secure Dicom’ on page 5-61 for more information. Figure 4-20.
Vscan Air Configuration (for iOS and Android) Configure Dicom Image Server (continued) 4. Press “Verify Server” to verify communication with the DICOM Image Server. “Verify server succeed” pop-up message displays if the communication with the Server is ok. Press OK and then Press “Add” to add the DICOM Image Server. If communication fails, check the server settings and make necessary corrections. Figure 4-21.
Configuration Configure Dicom Image Server (continued) 5. Once the Dicom Image Server is added, you will find the server name under Server Settings. If this is the first Dicom Image Server that you are adding, by default it will be the favourite server. If there are more than one Dicom Image Servers, you have to choose the desired Dicom Image Server as favourite server. To set Dicom Image Server as favourite, tap on the respective star mark and press YES on the pop-up message screen. Figure 4-22.
Vscan Air Configuration (for iOS and Android) Storage Commit Storage Server Storage Server is nothing but the Dicom Image Server that recieves and stores the Exam data from Vscan Air app. Commitment Server Commitment Server sends confirmation to the Vscan Air app when the Storage Server successfully recieves and stores the Exam data.
Configuration Configure Network Shared Folder Follow the procedure below to configure a new Network Shared Folder. 1. Press Menu -> Configuration -> Server Settings. Figure 4-23. Server Settings 2. Press Add Server in “Server Settings” screen. Figure 4-24.
Vscan Air Configuration (for iOS and Android) Configure Network Shared Folder (continued) 3. In “Add New Server” screen, select “Network Shared Folder” from the drop down list of “Server Type” and enter the configuration information in the respective fields to add Network Shared Folder. If you wish to share additional comprehensive exam information (Patient/Exam information), select the check box "Add comprehensive exam info". See ‘Comprehensive exam info’ on page 5-69 for more information. Figure 4-25.
Configuration Configure Network Shared Folder (continued) 4. Press “Verify Server” to verify communication with the Network Shared Folder. “Verify server succeed” pop-up message displays if the communication with the Server is ok. Press OK and then Press “Add” to add the Network Shared Floder. If communication fails, check the server settings and make necessary corrections. Figure 4-26.
Vscan Air Configuration (for iOS and Android) Configure Network Shared Folder (continued) 5. Once the Network Shared Folder is added, the server name will be available under Server Settings. If this is the first Network Shared Folder that you are adding, by default it will be the favorite server. If there are more than one Network Shared Folder, then one of them have to be chosen as the favorite Network Shared Folder.
Configuration Remove Server 1. To remove a server from the configured list of servers, Press Menu -> Configuration -> Server Settings. Figure 4-28. Server Settings 2. Press the desired server that needs to be removed. Figure 4-29.
Vscan Air Configuration (for iOS and Android) Remove Server (continued) 3. Swipe up and select “Remove Server”. The message “Do you want to delete server from list?” appears. Press YES to delete the server. Figure 4-30. Remove Server Security Exam Information/Patient Information can be protected by enabling a data access pin. Biometric authentication will if additionally enabled replace the need to enter the data access pin.
Configuration Ask for data access pin A data access pin can be configured to authorize access to exam data which may contain sensitive patient information. The data access pin can be configured after having registered the Vscan Air App. Follow the procedure below to set a data access pin. 1. Press Menu -> Configuration -> Security. Figure 4-31. Security settings 2. Tap on the Ask for data access pin button on the Security screen. Figure 4-32.
Vscan Air Configuration (for iOS and Android) Ask for data access pin (continued) 3. Enter a new 6 digit pin in the field on the “Set up data access pin” screen and Press Next button. Figure 4-33. NOTE: Enter data access pin Please make sure to use a strong pin and avoid using pin codes that are easy to guess. 4. Re-enter the pin on the “confirm data access pin” screen and Press Save button. After successful set up of data access pin, application takes you to the Security screen. Figure 4-34.
Configuration TouchID for quick data access (Biometric authentication) To enable biometric authentication for quick data access, follow the procedure below 1. Press Menu -> Configuration -> Security. Figure 4-35. Security settings 2. Tap on the TouchID for quick data access button on the Security screen to activate biometric authentication. Figure 4-36.
Vscan Air Configuration (for iOS and Android) TouchID for quick data access (Biometric authentication) (continued) NOTE: Before enabling biometric authentication in the Vscan Air Application, make sure you have activated finger print unlock or face recognition unlock in your display device. Failure to do so may pop-up the following warning message while enabling biometric authentication in the Vscan Air Application. Figure 4-37.
Configuration Change data access pin Follow the procedure below to change the data access pin. 1. Press Menu -> Configuration -> Security. Figure 4-38. Security settings 2. Tap on Change data access pin on the Security screen. Figure 4-39.
Vscan Air Configuration (for iOS and Android) Change data access pin (continued) 3. Under the “Change data access pin” screen, enter your existing pin, then enter new pin and Confirm the new pin. Press Save button. After successful set up of new data access pin, application takes you to the Security screen. Figure 4-40. NOTE: 4-30 Confirm data access pin Please make sure to use a strong pin and avoid using pin codes that are easy to guess.
Support Support Support The Support option displays - User manual, Hotline, Case library and Tutorials. Figure 4-41. • Support User Manual - to access the e-manual in the desired language. Figure 4-42. User Manual • Hotline - To access list of GEHC Service Centre contact numbers • Case Library - Vscan Air web page that provides access to reference image and case examples.
Vscan Air Configuration (for iOS and Android) Diagnostics Diagnostics The Diagnostics option displays - Run diagnostics and Send log. Figure 4-43. • Run Diagnostics - To run all the Diagnostic tests refer the section ‘Diagnostics Test’ on page 6-21. Figure 4-44.
Diagnostics Diagnostics (continued) • Send log - On selecting the send log button, the device will send diagnostics logs and system logs to the server. Figure 4-45. Send log warning - iOS NOTE: Android devices do use WiFi-direct and the display device will stay connected to the Vscan Air CL probe while sending the logs. NOTE: iOS devices might need to disconnect from the Vscan Air CL probe to send the logs depending on the availability of a mobile data connection.
Vscan Air Configuration (for iOS and Android) About About The About option displays - Registered devices, App version info, Probe version info, Regulatory, Account information and Acknowledgements. Figure 4-46.
About About (continued) App Details • Registered devices - Displays Connected Probe and App on this device. 1. Unregistered Probe 2. Registered Probe Figure 4-47. • Registered devices Unregister: To unregister Vscan Air CL probe or Vscan Air App, you select "Unregister" and confirm. If unregistered, Vscan Air CL probe will be disconnected. To re-register, you must connect and complete registration. If unregistered, Vscan Air App current registration and any connected probe will disconnect.
Vscan Air Configuration (for iOS and Android) About (continued) • App version info App version info - Displays App software version and App software revision. Figure 4-48. • App version info (example) Probe version info Probe version info - Displays Probe softwre version and Probe software revision 1. Unregistered Probe 2. Registered Probe Figure 4-49.
About About (continued) • Regulatory 1. Before registration 2. After registration Figure 4-50. • Regulatory Account information 1. Press the Account information tab. Figure 4-51.
Vscan Air Configuration (for iOS and Android) About (continued) 2. Use the existing Vscan Air user account email and password to log in. Figure 4-52. Connect to existing account 3. Update the account details if needed. Figure 4-53.
About About (continued) 4. Check to confirm the given information. 5. Press Submit, to update the Account details. Figure 4-54. • Account details Updated Acknowledgements - Displays the third party software licience. Figure 4-55.
Vscan Air Configuration (for iOS and Android) 4-40 Vscan Air – User Manual Direction GP092020-1EN Rev 08
Chapter 5 Using Vscan Air CL Contents: ‘Display Features’ on page 5-2 ‘Scanning’ on page 5-4 ‘Measurements’ on page 5-43 ‘Review and recall of stored data’ on page 5-46 ‘Preparing for a guided procedure with Vscan Air’ on page 5-50 ‘Export data’ on page 5-55 Vscan Air – User Manual Direction GP092020-1EN Rev 08 5-1
Using Vscan Air CL Display Features Left panel Swipe left to right or tap on the Vscan Air CL probe icon on left hand top corner to access presets and menu options. 1. Presets 2. Menu Figure 5-1. Left panel See ‘Probe and Presets’ on page 5-9 for more information.
Display Features Right panel Swipe right to left or tap on the Patient icon on the right hand side top corner to create a new exam, access current exam and data from previously saved exams. 1. Start new exam 2. Current exam 3. Previous Exams Figure 5-2. • Right Panel Start a new exam - Press New Exam on right corner at the bottom of the screen to start a new exam.
Using Vscan Air CL Scanning General scanning recommendations Before each use: Inspect the Vscan Air CL probe (see ‘Inspection’ on page 6-3). After Each Use • Inspect the Vscan Air CL (see ‘Inspection’ on page 6-3 ) • Clean the Vscan Air CL (see ‘Cleaning and disinfection’ on page 6-4). • If required, disinfect the Vscan Air CL (see ‘Cleaning and disinfection’ on page 6-4 ). Ensure that the Vscan Air CL is properly cleaned and disinfected after each use and before storing in the protective case.
Scanning Use of Gel (continued) The following gels have been tested to be compatible with the Vscan Air CL. Table 5-1: Compatible Gels Aquasonic Parker Laboratory Inc. Clear Image Sonotech Inc. Scan Parker Laboratory Inc. Sonogel Sonogel Vertriebs GmbH Wavelength National Therapy Products Inc. For more information regarding probe care, refer to the website:https://www.gehealthcare.
Using Vscan Air CL Other recommendations Like most high frequency computing devices, the electronic components of Vscan Air CL will generate some heat while operating normally and as intended. Vscan Air CL is equipped with safety mechanisms which will automatically reduce computing speed (frame rate), and ultimately shut down the device, before any risk of overheating occurs.
Scanning Probe orientation Vscan Air CL is provided with an orientation mark on both the transducer heads. This mark is used to identify the side of the Vscan Air CL probe corresponding to the side of the image having the orientation V mark on the scanning screen. A steady blue LED light on one end of the Vscan Air CL indicates which transducer head is active. 1. Orientation marking on Vscan Air CL 2. LED light 3. Orientation marking on screen Figure 5-3.
Using Vscan Air CL Patient examination Creating a new exam A new exam can be created in two ways: 1. Automatically - when the Vscan Air CL is turned ON and paired successfully with the Vscan Air app. 2. Manually - Create a New Exam from the right panel. • Swipe from right to left or tap the 'icon' on the right upper corner to bring out the right panel. • Press New Exam on the bottom right corner of the screen. Figure 5-4.
Scanning Storing an image/video Refer to sections ‘Storing an image’ on page 5-26 and ‘Storing a video’ on page 5-27. Probe and Presets Use of presets To ensure optimal image quality, the Vscan Air ultrasound system has predefined scanning settings optimized for different applications. Refer to the tables below to select the correct Vscan Air CL transducer and preset combination before scanning.
Using Vscan Air CL Use of presets (continued) Table 5-3: Linear array transducer 5-10 Linear array (shallow scanning) transducer presets Preset Optimized for Vascular • Veins • Arteries Nerves Peripheral nerves Small Parts • Small organs • Pediatric (recommended minimum weight: 4 kg) • Soft tissue MSK Musculoskeletal superficial • Joints • Long bones • Muscles • Tendons • Ligaments Lung • Thoracic/Pleural motion • Fluid detection Neo Head Neonatal cephalic Ophthalmic Ophthalmic Vscan Air –
Scanning To change the preset and probe 1. Slide from left to right or tap the preset icon on the leftmost top corner of the scan screen. All presets available for Vscan Air CL are displayed. Presets are grouped according to the deep scanning (Curved array) and shallow scanning (Linear array) ability of the Vscan Air CL. 1. Presets Figure 5-5. Preset menu 2. Select the desired preset. The preset selected automatically activates the transducer for that preset. 3.
Using Vscan Air CL To set a preset as default Press and hold the preset which needs to be set as default. A small blue bar displays on the bottom of the preset indicating that it is set as default. 1. Blue Bar Figure 5-6.
Scanning Resolution and Penetration setting For a few presets, there is a control available in the black and white mode for alternating between Resolution and Penetration settings. Resolution setting is the default setting optimized for high resolution imaging balancing adequate penetration for average sized patients. Penetration setting is useful for imaging at greater depths by optimizing visualization of structures in the far-field in larger than average or difficult to scan patients.
Using Vscan Air CL Resolution and Penetration setting (continued) To switch between the ‘Resolution’ (default) and ‘Penetration’ settings, tap on the . The icon indicates that the ‘Penetration’ setting is selected and icon indicates default or ‘Resolution’ setting is selected. Depth is maintained while alternating between the two settings. 1. Resolution setting (default) 2. Penetration setting Figure 5-7.
Scanning Black/white imaging (B-mode) NOTE: Scanning does not start if the Vscan Air CL is not connected to a Vscan Air App. Black and white imaging is intended to provide two-dimensional images and measurement capabilities concerning the anatomical structure of soft tissue. Black and white imaging is the default scanning mode. Figure 5-8. NOTE: Black/ white (B-mode) scan screen As a safety precaution, scanning is not possible when charging the Vscan Air CL probe.
Using Vscan Air CL Black and white imaging adjustments Gain Black and white gain increases or decreases the amount of echo information displayed in an image. It may have the effect of brightening or darkening the image if sufficient echo information is generated. 1. Swipe at least half a centimeter from the left or right on the scan screen to initiate a gain change. Figure 5-9. NOTE: Drag Small movements will be ignored to avoid unintentional activation of the gain control. 2.
Scanning Time Gain Compensation (TGC) TGC amplifies returning signals to correct for the attenuation caused by tissues at increasing depths. TGC sliders are spaced proportionately to the depth. The area each slider amplifies varies as well. Turn ON or OFF the TGC Controls from the Menu screen. The TGC controls are displayed on the scan screen as soon as you start adjusting gain by sliding your finger on any part of the image.
Using Vscan Air CL Depth Depth adjusts the field of view. It increases the field of view to look at larger or deeper structures; it decreases the field of view to look at structures near the skin line. 1. Swipe your finger up/down on the screen at least half a centimeter to initiate depth Figure 5-12. NOTE: Depth adjustment Small movements will be ignored to avoid unintentional activation of the Depth control. At the start of the swipe, the depth indicator shows the depth change. 2.
Scanning Color flow (Color doppler) The Color flow (Color doppler) mode is adding color coded qualitative information concerning the relative velocity (in m/s) and direction of fluid motion within the black and white image. 1. Press the Color icon. A color flow area displays on top of the black and white image. Figure 5-14. Color icon 2. Drag the color Region of Interest (ROI) to the desired area. The color ROI outline becomes blue when active.
Using Vscan Air CL Color imaging Scanning Adjustments NOTE: The color images can be zoomed by pinching the images with two fingers. NOTE: The active gain control is disabled as long as the TGC controls are active. Color Gain Color gain amplifies the overall strength of echoes processed in the color area. 1. Swipe at least half a centimeter from the left or right on the scan screen to initiate gain. NOTE: Small movements will be ignored to avoid unintentional activation of the color gain control. 2.
Scanning Position and resize ROI The size of the Region of Interest (ROI) has an effect on the frame rate. The width of the ROI has a significant effect on frame rate even more than the height of the ROI. Keep the box sized just to the anatomy of interest and as close to center as possible. Drag your finger inside the ROI to move and position. The box turns blue indicating that the controls for adjusting the ROI are activated. Use the controls on the corners to adjust size. a.
Using Vscan Air CL Color steer Slant the ROI (Region of Interest) of the Color Flow linear image left or right to get more information without moving the Vscan Air CL probe. Use the controls on the center top and bottom to steer the angle. NOTE: Color steer applies only when using the linear array transducer of the Vscan Air CL. Color Aliasing If the blood flow velocity exceeds the Nyquist limit indicated by the number displayed with the velocity bar aliasing may occur.
Scanning Pulse repetition frequency - Fast and slow flow (High and low velocity scale) For a few presets, there is a control available in the color flow mode for alternating between high and low velocity scales. A higher velocity scale is needed to avoid aliasing while imaging of faster (arterial) flow. A lower velocity scale optimizes the imaging of slow low (venous).
Using Vscan Air CL Pulse repetition frequency - Fast and slow flow (High and low velocity scale) (continued) To change the velocity scale, tap on the to alternate between the velocity scales. The indicates that the higher velocity scale is selected and indicating the lower scale. The velocity setting corresponding to both scales can be seen at the top of the velocity bar . 1. High velocity scale (default) 2. Low velocity scale Figure 5-16.
Scanning Freeze To freeze an image: 1. Press the Freeze button or tap anywhere on the image area on the scan screen. Figure 5-17. Tap or press When in freeze mode, you can store an image or review frames in the available video buffer. To reactivate the image: 1. Press Freeze icon again. OR Tap anywhere on the image. Video buffer Video buffer displays with an ability to scroll, play and pause the frames in the video buffer.. The indicator is placed on the last frame. To jump frames: 1.
Using Vscan Air CL Storing an image Press Store button on the scan screen when the image is frozen to store a still image. Figure 5-18.
Scanning Storing a video To store a video: 1. Press the 'Store' button on the scan screen when the image is live. OR 2. Play the video buffer by using the 'Play' button on the video scroll bar and then press Store. Press Store button on the scan screen to store a video. Figure 5-19.
Using Vscan Air CL Protected Health Information Protected Health Information is the data that helps in identifying a patient. It is possible to either manually enter patient details/ patient data in the Vscan Air application or assign patient/Study information from a scheduled exam retrieved from the Modality Worklist Server. Assign Patient data manually to the current exam To assign patient details manually to the current exam in Vscan Air application, follow the procedure below. 1.
Scanning Assign Patient data manually to the current exam (continued) 2. Press “Edit Patient” and enter the required information in the respective fields under “New Patient” screen. Press "Add" button to assign Patient data to the current exam. After successful assignment of Patient data, application takes you to the scan screen. Figure 5-21. NOTE: Edit Patient Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam.
Using Vscan Air CL Assign Patient data manually to the current exam (continued) 3. Patient’s Last Name, First Name and ID are shown on the top of the scan screen. Figure 5-22. Scan Screen with Patient data 4. Press Patient icon to view the images/videos under current exam.
Scanning Assign Patient data manually to an existing Exam To assign patient details manually to an existing exam in Vscan Air application, follow the procedure below. 1. Swipe from right to left. or Press Patient icon on the top right corner. Figure 5-23. Patient Icon 2. Press Exams tab. Press the desired Exam ID for which you wish to assign Patient data. Figure 5-24. Exam Tab NOTE: Patient data can be assigned to an individual exam only.
Using Vscan Air CL Assign Patient data manually to an existing Exam (continued) 3. Press “Edit Patient” button at top right corner and enter the required information in the respective fields under “New Patient” screen. Press "Add" button to assign Patient data to the existing exam. After successful assignment of Patient data, application takes you to the scan screen. Figure 5-25.
Scanning Assign Patient data manually to an existing Exam (continued) 4. Patient’s Last Name, First Name and ID are shown on the top of the scan screen. Figure 5-26. Scan Screen with Patient data 5. Press Patient icon to view the images/videos under the existing exam.
Using Vscan Air CL Assign Patient data from Modality Worklist Server to the current exam Protected Health Information is added under each patient name in the Modality Worklist Server. To assign Patient data from Modality worklist Server to the current exam in the Vscan Air application, follow the procedure below. 1. Swipe from right to left. or Press Patient icon on the top right corner. Figure 5-27. NOTE: 5-34 Patient Icon Patient data can be assigned to an individual exam only.
Scanning Assign Patient data from Modality Worklist Server to the current exam (continued) 2. Press “Edit Patient” and then Press the right corner of “New Patient” screen. Figure 5-28.
Using Vscan Air CL Assign Patient data from Modality Worklist Server to the current exam (continued) 3. Press the refresh button on the “Worklist” screen to import the list of patients from Modality Worklist Server. Tap on the desired Patient Name/Patient ID. OR Enter Patient Name or Patient ID in the search field to find the details of particular patient. Figure 5-29.
Scanning Assign Patient data from Modality Worklist Server to the current exam (continued) 4. Press "Add" button to assign Patient data to the current exam. After successful assignment of Patient data, application takes you to the scan screen. Patient’s Last Name, First Name and ID are shown on the top of the scan screen. Figure 5-30. NOTE: Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam. 5.
Using Vscan Air CL Assign Patient data from Modality Worklist Server to an existing exam Protected Health Information is added under each patient name in the Modality Worklist Server. To assign Patient data from Modality worklist Server to an existing exam in the Vscan Air application, follow t.he procedure below. 1. Swipe from right to left. or Press Patient icon on the top right corner. Figure 5-31. NOTE: 5-38 Patient Icon Patient data can be assigned to an individual exam only.
Scanning Assign Patient data from Modality Worklist Server to an existing exam (continued) 2. Press Exams tab. Press the desired Exam ID for which you wish to assigh Patient data. Figure 5-32.
Using Vscan Air CL Assign Patient data from Modality Worklist Server to an existing exam (continued) 3. Press “Edit Patient” button at top right corner. Press the symbol on “New Patient” screen. Figure 5-33.
Scanning Assign Patient data from Modality Worklist Server to an existing exam (continued) 4. Press the refresh button on the “Worklist” screen to import the list of patients from Modality Worklist Server. Tap on the desired Patient Name/Patient ID. OR Enter Patient Name or Patient ID in the search field to find the details of particular patient. Figure 5-34. Search Patient NOTE: Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connected to same network.
Using Vscan Air CL Assign Patient data from Modality Worklist Server to an existing exam (continued) 5. Press "Add" button to assign Patient data to the existing exam. After successful assignment of Patient data, application takes you to the scan screen. Patient’s Last Name, First Name and ID are shown on the top of the scan screen. Figure 5-35. NOTE: Add Patient Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam. 6.
Measurements Measurements Taking measurements Vscan Air app enables two types of measurements with the Vscan Air CL probe - distance and ellipse, on frozen images in both black and white and color imaging. Up to four distance measurements can be performed on an image. Measurements can be done during image review or on recalled stored images. To perform a distance measurement: 1. On a frozen image, press Measure. The measurement calipers displays.
Using Vscan Air CL Taking measurements (continued) To make additional measurements: 1. Press the distance measurement icon again to make additional measurements on the displayed image. Up to 4 distance measurements can be made on a single image. To delete a distance measurement: 1. Select the measurement you wish to delete. 2. Press ‘Bin‘ icon to delete the selected measurement. To perform an ellipse measurement: 1. On a frozen image, press the ‘Measure’ button.
Measurements Taking measurements (continued) To delete an ellipse measurement: 1. Select the measurement. 2. Press the ‘Bin’ icon to delete the selected measurement. To exit the Measure mode select the 'Measure‘ icon or press ‘Freeze’ icon or switch frame with Video buffer slider.
Using Vscan Air CL Review and recall of stored data Review Current Exam 1. Swipe from right to left. OR Tap on Patient icon on the top right corner. Images and video loops captured in current exam is shown. 2. Select to activate and review stored images. 1. 2. 3. 4. 5. 6. Image orientation marker Recalled image preset icon Recalled image exam number Recalled image depth Recalled image preset Recalled image date and time Figure 5-38.
Review and recall of stored data Review Saved Exams 1. Swipe from right to left. OR Tap on Patient icon on the top right corner. 2. Tap Exams on top tab. Saved exams will show in a list. Most recent exams are shown on top. NOTE: When accessing Exam list, select the desired image to go to the viewer. The Viewer opens with selected image and the Exam list closes. The freeze button becomes active. You can unfreeze to continue scanning using the current exam. The Exam list then closes.
Using Vscan Air CL Delete individual images/videos 1. Press Select. 2. Tap Select box on the image/video. 3. Press the ‘Bin‘ icon to delete. Clear selection 1. Press Select All. 2. Press Clear all to clear the selection if you do not wish to delete. NOTE: If deleting the Vscan Air App from the display device, the App data, including all exam data including the images and videos will be deleted.
Review and recall of stored data To exit review mode In portrait mode, tap on scan screen or swipe out panel. In landscape mode, swipe out panel. Export data The Vscan Air CL is regarded an imaging acquisition device and not an image storage device or image archive. Make sure to share images, videos (loops) or exams via the share function on the Vscan Air app. Disclaimer: When sharing data from the Vscan Air app, data can be shared to other apps including anonymized images and movies/loops.
Using Vscan Air CL Preparing for a guided procedure with Vscan Air A wireless probe has a limited inherent risk of a disrupted connection due to various factors that could lead to loss of real time imaging.
Preparing for a guided procedure with Vscan Air Assessing Display Device Wi-Fi Performance with Vscan Air probe Prior to setting up for a guided procedure, it is recommended to check if the display device being planned for use during the procedure supports a stable connection with the Vscan Air probe, by following the below steps. Step Step name Description 1 Configure app settings Set the Video duration to 1 second from Menu -> Configuration.
Using Vscan Air CL General considerations 5-52 • There may be differences in the physical characteristics of a wireless probe (shape, design, weight etc.) and the way it might be handled during a scan or a procedure when compared to a probe attached to a console. Hence, it is recommended for users to get comfortable with handling the Vscan Air device prior to performing a procedure to minimize accidental dropping or slipping of the probe during the procedure.
Preparing for a guided procedure with Vscan Air Setting up device for procedure Please read and follow the below instructions to prepare the device before performing a dynamic ultrasound guided procedure with Vscan Air. Step Step name Description 1 Configure app settings • If working with a display device for the first time, use an example image to adjust the brightness level for optimal visualization of the image based on the ambient environment where the procedure is expected to be performed.
Using Vscan Air CL Step Step name Description 3 Minimize lost connection between probe and mobile device during scan The probe without a cable can be very helpful to support sterile procedures. At the same time its use depends on bandwidth and stability of the wireless connection between probe and mobile device. Following are the recommendations for minimizing loss of real time images due to connection instability: a.
Export data Export data Use the share functionality to share important data to a selected storage destination if needing to secure data storage. Share individual images/videos 1. Swipe from right to left. OR Press Patient icon button on the top right corner. A list of stored images or videos for the current exam display. 2. Select the desired exam or video you wish to share. 3. Press Share icon. 4. Choose the Share function on your display device to share the images/videos.
Using Vscan Air CL Share Exams 1. Press Exams tab on the right panel. 2. Select the desired single/multiple exam IDs from Exams list. 3. Press Share icon. 4. Choose the Share function on your display device to share the entire single/multiple Exams. Export data to the Dicom Image Server To export images/Videos/Exams from Vscan Air application to DICOM Image Server, follow the procedure below. 1. Swipe from right to left. OR Press Patient icon on the top right corner. Figure 5-40.
Export data Export data to the Dicom Image Server (continued) 2. Press “Exams” tab and select the desired Exam from which you wish to share images/videos. Figure 5-41.
Using Vscan Air CL Export data to the Dicom Image Server (continued) 3. Select the desired image or video you wish to export and Press the Share icon. See ‘Share individual images/videos’ on page 5-55 for more information. OR Select all images or videos you wish to export and Press the Share icon. See ‘Share all images/videos from an exam’ on page 5-55 for more information. OR Select the desired single/multiple exams you wish to export from Exams list and Press the Share icon.
Export data Export data to the Dicom Image Server (continued) 4. Select the Dicom Image Server as storage destination and Press OK button to initiate the export. If there are more than one Dicom Image servers, select the desired Dicom Image Server as storage destination. Figure 5-43. Share Images/Videos NOTE: You can also select all the servers simultaneously, if you wish to share the data with all the servers that supports data exporting.
Using Vscan Air CL Export data to the Dicom Image Server (continued) 5. You will find Image Queue with remaining items in the Queue. In addition to image queue you will also find export status of image/Video/Exam, where a green dot on the image/Video/ Exam indiactes it is successfully exported and a red dot indicates the export is failed. Figure 5-44.
Export data Export data to the Dicom Image Server (continued) In one attempt you can export maximum of 200 images. When you try to export more than 200 images in a single attempt, application throws the following warning message. Figure 5-45. Export limit warning message NOTE: The application initiates an Auto Retry in case of a failed export due to various reasons including network interruption.
Using Vscan Air CL Secure Dicom (continued) Figure 5-46. Select Secure Dicom 2. Under Secure Dicom select the desired Security Profile. Figure 5-47.
Export data Secure Dicom (continued) 3. Press the Add Server Certificate button, to upload the server certificate. Figure 5-48. Add Server Certificate 4. Press the Add Client Certificate button, to upload the Client certificate. Figure 5-49.
Using Vscan Air CL Secure Dicom (continued) 5. Press the Add Client Key button, to upload the Client Key. Figure 5-50. Upload Client Key 6. After successful uploading of the certificates, you can verify the server.
Export data Export data to the Network Shared Folder To export images/Videos/Exams from Vscan Air application to Network Shared Folder, follow the procedure below. 1. Swipe from right to left. OR Press Patient icon on the top right corner. Figure 5-51. Patient Icon 2. Press “Exams” tab and select the desired Exam from which you wish to share images/videos. Figure 5-52.
Using Vscan Air CL Export data to the Network Shared Folder (continued) 3. Select the desired image or video you wish to export and Press the Share icon. See ‘Share individual images/videos’ on page 5-55 for more information. OR Select all images or videos you wish to export and Press the Share icon. See ‘Share all images/videos from an exam’ on page 5-55 for more information. OR Select the desired single/multiple exams you wish to export from Exams list and Press the Share icon.
Export data Export data to the Network Shared Folder (continued) 4. Select the Network Shared Folder as storage destination and Press OK button to initiate the export. If there are more than one Network Shared Folders, select the desired Network Shared Folder as storage destination. Figure 5-54. Share Images/Videos NOTE: You can also select all the servers simultaneously, if you wish to share the data with all the servers that supports data exporting.
Using Vscan Air CL Export data to the Network Shared Folder (continued) Figure 5-55. Image Queue In one attempt you can export maximum of 200 images. When you try to export more than 200 images in a single attempt, application throws the following warning message. Figure 5-56. NOTE: 5-68 Export limit warning message Once you initiates the export of images/Videos/Exam, the Protected Health Information related to that particular exam becomes read only in the application.
Export data Comprehensive exam info While configuring network shared folder, you can optionally configure to export the below mentioned exam data along with media files. See ‘Configure Network Shared Folder’ on page 4-19 for more information. The Exam Data that can be exported to Network Shared Folder along with the media files is Exam ID, Patient’s First Name, Patient’s Last Name, Patient ID. Network Shared Folder Structure Network Shared Folder structure is as follows in different scenarios: 1.
Using Vscan Air CL Network Shared Folder Structure (continued) 3. If only “Patient ID” and “Last Name” are assigned to an Exam If only “Patient ID” and “Last Name” is assigned to an Exam, the Network Shared Folder structure appears as below after exporting to your PC. The media files are stored in a series of folders.
Export data Export data to other apps (Social Networking Applications) To export images/Videos/Exams from Vscan Air application to Social Networking Applications, follow the procedure below. 1. Swipe from right to left. OR Press Patient icon on the top right corner. Figure 5-57. Patient Icon 2. Press “Exams” tab and select the desired Exam from which you wish to share images/videos. Figure 5-58.
Using Vscan Air CL Export data to other apps (Social Networking Applications) (continued) 3. Select the desired image or video you wish to export and Press the Share icon. See ‘Share individual images/videos’ on page 5-55 for more information. OR Select all images or videos you wish to export and Press the Share icon. See ‘Share all images/videos from an exam’ on page 5-55 for more information. OR Select the desired single/multiple exams you wish to export from Exams list and Press the Share icon.
Export data Export data to other apps (Social Networking Applications) (continued) 4. Press “Share (with other apps)” to share images/videos/ Exams to a social networking application. Figure 5-60. Share Images/Videos 5. Tap on the desired social networking application to initiate the export.
Using Vscan Air CL 5-74 Vscan Air – User Manual Direction GP092020-1EN Rev 08
Chapter 6 Vscan Air Maintenance Contents ‘System care and maintenance’ on page 6-2 ‘Cleaning and disinfection’ on page 6-4 ‘Upgrades’ on page 6-17 ‘Troubleshooting’ on page 6-20 ‘Probe warning messages’ on page 6-26 Vscan Air – User Manual Direction GP092020-1EN Rev 08 6-1
Vscan Air Maintenance System care and maintenance Overview CAUTION Only trained persons should perform the safety inspections. The Vscan Air CL requires regular care and maintenance to function safely and properly. The expected service life of the Vscan Air CL is 5 years. To ensure that the Vscan Air constantly operates at maximum efficiency, we recommend that the following procedures be observed as part of the customer’s internal routine maintenance program.
System care and maintenance Inspection Inspecting the Vscan Air CAUTION If any defects or damages are found on the Vscan Air CL probe, do not use it. Contact GEHC. Examine the following on a monthly basis (or whenever there is a reason to assume that any issue may have occurred): • WARNING Equipment for cracks, loose or missing hardware. To avoid electrical shock hazard, do not remove covers from the Vscan Air CL. Before each use 1. Inspect the lens and the probe housing. 2.
Vscan Air Maintenance Cleaning and disinfection Reprocessing recommendation (Frequency) After Each Use 1. Inspect the Vscan Air CL (See ‘Inspecting the Vscan Air’ on page 6-3). 2. Clean the Vscan Air CL. 3. If required, clean the display device. NOTE: The display device should be cleaned and/or disinfected according to the device manufacturer's recommendations. Example: https://support.apple.com/en-us/HT204172.
Cleaning and disinfection Cleaning and disinfection Adequate cleaning and disinfection between patient cases are necessary to prevent disease transmission. All probes must be thoroughly cleaned prior to disinfection. The level of disinfection required is based on patient contact. Use the following guidance to determine the appropriate level of disinfection based on system use.
Vscan Air Maintenance Special Label Designations, Warnings and Precautions Never use thinner, benzene, abrasive cleaners, or other strong solvents, as these may cause damage to the Vscan Air CL. Special accessories Special accessories are not applicable.
Cleaning and disinfection Probe Reprocessing Vscan Air CL Pre-Treatment at the Point of Use (Required for all Vscan Air CL probes) The pre-treatment step is for removal of gel and to minimize risk for cross contamination. 1. After each use, - remove the protective sheath from the Vscan Air CL if used. - gently remove all coupling gel from the Vscan Air CL by wiping with a soft, low lint cloth. CAUTION Do not use abrasive paper products when cleaning or wiping a GEHC ultrasound probe.
Vscan Air Maintenance Manual cleaning Instructions Manual cleaning is required to ensure the Vscan Air CL is cleaned to the extent necessary for further processing. When cleaning select one of the cleaning methods described below, cleaning using wipes or cleaning using a cleaning solution. Cleaning using Wipes 1. Dispense a cleaning wipe from the wipe canister. 2. Hold the Vscan Air CL with the large lens facing away from your body. 3.
Cleaning and disinfection Cleaning using a cleaning solution 1. Prepare a basin with enzymatic cleaner per the manufacturer’s instructions. 2. Immerse probe in the cleaning solution and ensure no air bubbles are trapped. 3. Use a soft nylon bristle brush to clean the probe. Do Not use the brush on the probe lenses as this can damage the soft acoustic lens. 4. Ensure the probe remains in the cleaning solution for the minimum contact time listed on the enzymatic cleaner label.
Vscan Air Maintenance Low-level/Intermediate level disinfection with wipes 1. Use a clean set of gloves. 2. Hold the Vscan Air CL with the large lens facing away from your body. 3. Wipe the Vscan Air CL from the large lens to the small lens, slightly rotating the Vscan Air CL after each wiping pass. 4. Turn the Vscan Air CL so that the small lens is facing away from your body. 5. Use a new wipe and apply to the small lens.
Cleaning and disinfection High-level disinfection – Soak High-Level Disinfection is required for devices that contact non-intact skin. In order for cleaner to be effective, all visible residue must be removed during the cleaning process. Follow the cleaning instructions as given in ‘Manual cleaning Instructions’ on page 6-8 to clean the probe before performing disinfection. Do not soak probes in cleaner for longer than stated by the chemical manufacturers instructions for use.
Vscan Air Maintenance Choosing a Disinfectant When choosing a disinfectant, determine the required level of disinfection. If the possibility of cross-contamination or exposure to unhealthy or non-intact skin exists, then high level disinfection should be performed. Good hand hygiene practice is highly recommended to help further reduce the risk of cross-contamination.
Cleaning and disinfection Covering the Vscan Air CL using a Sterile, Protective Sheath CAUTION Vscan Air CL probe sheaths should be used in any clinical situation where infection is a concern. 1. Place an appropriate amount of gel inside the protective sheath and/or on the transducer face. NOTE: Failure to use imaging gel may result in poor image quality. 2. Insert Vscan Air CL into sheath, making sure to use proper sterile technique.
Vscan Air Maintenance Cleaning the protective case The protective case is compatible with the set of cleaners and disinfectants listed for the Vscan Air CL probe. When cleaning the protective case pay special attention to its edges and grooves. Requirements for the protective case cleanliness will be defined by the way the protective case is implemented in the workflow for storing the Vscan Air CL probe.
Cleaning and disinfection GEHC ultrasound transducers web site The GEHC Ultrasound transducers web site contains a list of chemicals that have been tested for compatibility with GEHC ultrasound probes. Verify probe compatibility via the GEHC ultrasound transducers web site. The reprocessing instructions provided in this document have been validated with the chemicals specified in ‘Chemicals used for Efficacy Validation with Vscan Air CL’ on page 6-5. GEHC ultrasound transducers web site https://www.
Vscan Air Maintenance Chemicals compatible with Vscan Air CL The table below lists the chemicals that were tested for compatibility with the probes. WARNING Table 6-2: Trade Name The chemicals listed below are compatible with Vscan Air CL and will not cause degradation, but have not been proven to effectively clean or disinfect the probe. If you are interested in using an alternate chemical from the compatibility tables, please contact your GEHC representative.
Upgrades Upgrades Upgrade software Download App software upgrades when available from either Google Play store or Apple Store. Vscan Air CL probe software After downloading an App software upgrade the Vscan Air CL probe software might need to be upgraded. Follow the on-screen instructions when connecting the probe to the App to upgrade probe software. NOTE: The system reverts to the previous active installation, if a power cycle happens before the probe software upgrade is completed.
Vscan Air Maintenance Vscan Air CL probe software upgrade 1. Pair the Vscan Air CL probe to the app. If the probe software need to be updated it prompts for an upgrade ‘probe needs update’. Click on ‘start update’. 2. The probe update is in progress.
Upgrades Vscan Air CL probe software upgrade (continued) 3. The probe update process takes around 3 to 5 mins. 4. When the probe update is complete the probe turns off. The user will need to start the probe whenver probe needs to be used again.
Vscan Air Maintenance Troubleshooting Troubleshooting Table 6-3: Problem Troubleshooting Possible cause Solution Vscan Air CL has no power. When battery is discharged. Charge the Vscan Air CL probe for at least 10 minutes and then power on. Battery defect or end of life. . Contact GEHC Service (see ‘Contact Information’ on page 1-13) Vscan Air CL is not charging. Defective battery or probe hardware issue Contact GEHC Service (see ‘Contact Information’ on page 1-13) Defective AC adapter.
Diagnostics Diagnostics Diagnostics Test 1. Slide the left panel. 2. Press Diagnostics from the Menu. Figure 6-3. Diagnostics Menu 3. Press the Run Diagnostic button to start the test.
Vscan Air Maintenance Diagnostics Test (continued) 4. Press the ‘Start’ button to start the diagnostics test. The progress will be shown at the bottom of the screen. NOTE: The display device must be connected to a probe to be able to start the diagnostics. 1. Diagnostic screen 2. Diagnostic progress bar Figure 6-4.
Diagnostics Diagnostics Test (continued) Figure 6-5. Diagnostics Process 5. If the Diagnostics test passes the below screen displays: Figure 6-6.
Vscan Air Maintenance Diagnostics Test (continued) You can share device logs with GEHC for instance, if diagnostic test fails. Figure 6-7. Diagnostics Failed 6. GEHC service guides the customer through the procedure to upload the system log file. NOTE: System logs exported from the device will be stored for GEHC service access 1 year before being deleted from the server. 7. GEHC service runs checklist. 8. GEHC service places the order for the replacment Vscan Air CL and provides shipment details.
Diagnostics Transducer Element test The transducer element test transmits/receives on each element to determine if the element working as intended. If the Element test fails, the failing element(s) are reported in the system logfile. The transducer element test is part of the probe diagnostics test which is found via the app Menu -> Diagnostics -> Run Diagnostics. The element test is then executed as part of a predefined test list of diagnostic tests.
Vscan Air Maintenance Probe warning messages Probe errors Probe overheats WARNING Probe is overheating and the system will shut down. If the problem persists, contact GEHC. Battery low WARNING Battery critically low. Connect charger immediately. Probe voltage critical WARNING Probe voltage is at critical level and will shut down. If the problem persists, contact GEHC. Connectivity error WARNING 6-26 Unable to connect. Check your internet connection and try again.
Probe warning messages Handling a defective Vscan Air CL probe or battery If the Vscan Air CL is damaged and needs a replacement, make sure you clean and disinfect the Vscan Air CL, pack it in the packing box, before shipping or returning to GEHC. If the battery does not charge, or if it is damaged. Contact GEHC for battery replacement. Automatic deactivation of the Vscan Air app Deactivation soft limit The Vscan Air App will on a daily basis try to contact the Vscan Air Product Registration server.
Vscan Air Maintenance Deactivation hard limit The Vscan Air App will on a daily basis try to contact the Vscan Air Product Registration server. If the Vscan Air app is inactive and/or not connected to internet for more than 110 days the Vscan Air app is deactivated and you will see the following message when you try to use the app. Figure 6-9.
Chapter 7 Appendix Contents: ‘Specifications’ on page 7-2 ‘Acoustic Output’ on page 7-3 ‘Appendices’ on page 7-15 ‘Measurement accuracy’ on page 7-16 ‘Indications Reference Guide’ on page 7-18 Vscan Air – User Manual Direction GP092020-1EN Rev 08 7-1
Appendix Specifications Dimension and weight (maximum) • Dimension: 131 x 64 x 31 mm (length, width, height) • Weight: 205 +/- 3g Curved array transducer for deep scanning • Broad-bandwidth curved array: from 2 - 5 MHz with center frequency of 3.3 MHz • Number of elements: 128 • Footprint: 64 mm x 16 mm (lens) • Viewing angle: 60° • Depth: up to 24 cm Linear array transducer for shallow scanning 7-2 • Broad-bandwidth linear array: from 3 - 12 MHz with center frequency of 7.
Acoustic Output Acoustic Output The real-time display of acoustic output indices The Vscan Air software have real-time display features according to IEC62359 Ed.2. A thermal (TI) and a mechanical (MI) index is displayed. These two indices are intended to estimate the potential for thermal and mechanical bioeffects induced by ultrasound. Both TI and MI are displayed with increments of 0.1. The displayed (estimated) TI and MI are nominal values.
Appendix Mechanical Index MI is the estimated likelihood of tissue damage due to cavitation. MI is defined as: equivalent to Track3 MI when the depth ZMI=Zsp. The MI will not exceed a value of 1.9 according to Track 3 in the FDA 510(k) guidance of September 9, 2008. The depth for pr,a (z) is not limited by the Break-Point Depth. The MI according to IEC62359 Ed2 will not exceed 1.9.
Acoustic Output Controls Affecting Acoustic Output The initial means by which the user can affect acoustic output are by 1) selecting a probe, 2) selecting an application (exam category) and then 3) selecting the imaging mode or imaging characteristics (depth, color ROI center position). This is achieved through an acoustic output control scheme in which all parameters that directly or indirectly affect acoustic output are fed to the control algorithm.
Appendix Probe surface temperature safety mechanisms The system has an Probe Surface Temperature Control Algorithm to ensure that each probe is set up and run within temperature limits given by the harmonized safety standard IEC60601-2-37. The Control Algorithm is implemented in the software and calibrated by laboratory measurements of surface temperature on each probe type.
Acoustic Output Acoustic Parameters as Measured in Water Definitions, symbols and abbreviations The following definitions, symbols and abbreviations are used in the acoustic output reporting tables in this chapter:: IEC Meaning—IEC/EN62359 Ed.
Appendix Operating Conditions All table entries are with the operating conditions specified at the end of the table.
Acoustic Output Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37 NOTE: These acoustic output reporting tables are produced according to IEC 62359 Ed.2. NOTE: The Acoustic Output tables are in English only. Transducer Model: Curved array transducer Operating Mode: black and white (including harmonic) Figure 7-1. NOTE: Curved array transducer - black/white (including harmonic) This transducer does not have a preset optimized for Transcranial/Neonatal cephalic use.
Appendix Transducer Model: Curved array transducer Operating Mode: black and white (including harmonic) and color Figure 7-2. Curved array transducer - black/white (including harmonic) and color NOTE: 7-10 This transducer does not have a preset optimized for Transcranial/Neonatal cephalic use.
Acoustic Output Transducer Model: Linear array transducer Operating Mode: black and white (including harmonic) Figure 7-3. NOTE: Linear array transducer - black/white (including harmonic) This transducer does not have a preset optimized for Obstetric/ Fetal use.
Appendix Transducer Model: Linear array transducer Operating Mode: black and white (including harmonic) and color Figure 7-4. Linear array transducer - black/white (including harmonic) and color NOTE: 7-12 This transducer does not have a preset optimized for Obstetric/ Fetal use.
Acoustic Output Transducer Model: Linear array transducer Operating Mode: black and white, Ophthalmic Figure 7-5. NOTE: Linear array transducer - black/white, Ophthalmic The Linear array Ophthalmic preset is not optimized for Obstetric/Fetal or Transcranial/Neonatal cephalic use.
Appendix Transducer Model: Linear array transducer Operating Mode: black and white and color, Ophthalmic Figure 7-6. NOTE: 7-14 Linear array transducer - black/white and color, Ophthalmic The Linear array Ophthalmic preset is not optimized for Obstetric/Fetal or Transcranial/Neonatal cephalic use.
Appendices Appendices Statements on the safety of ultrasound October 1982, revised March 1983 and October 1983. Diagnostic ultrasound has been in use for over 35 years. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound In medicine herein addresses the clinical safety of such use.
Appendix Measurement accuracy Measurement accuracy The following information is intended to provide guidance to the user in determining the amount of variation or measurement error that should be considered when performing clinical measurements with this equipment. Error can be contributed by equipment limitations and improper user technique. Be sure to follow all measurement instructions and develop uniform measurement techniques among all users to minimize the potential operator error.
Measurement accuracy Measurement accuracy (continued) Table 7-2: Measurement accuracy - Linear array (shallow scanning) transducer Measurement Unit Useful range Accuracy Distance Axial cm or mm 1mm-60mm ±0.
Appendix Indications Reference Guide Disclaimer The information in this section is meant to be reference for examples of anatomies and examinations that can be evaluated by this product. The list may not be all inclusive. Curved Array (Deep scanning) Transducer The curved array transducer on Vscan Air CL supports Black/ white (B-mode), Color (Color doppler) and Harmonic imaging modes.
Indications Reference Guide Table 7-3: Clinical Application Curved Array Transducer Anatomy Evaluation OB-Gyn • Uterus and endometrium • Ovaries • Cervix • Pouch of Douglas (POD) • Gestational Sac (GS) • Placenta • Amniotic fluid • Fetus(es) • GS location (Intra-uterine/ extra-uterine) • Fetal viability/ heart motion • Placenta position- (including low-lying and previa) • Fetal position and presentation • Amniotic fluid assessment • Cervical length measurement/ cervical insufficiency • Fetal well-bein
Appendix Table 7-3: Clinical Application Curved Array Transducer Anatomy Evaluation Procedure guidance (Adult/ Pediatrics) • Heart • Lung • Uterus • Abdomen • Thorax • Bladder • Nerve plexus • Hip/Knee/ Shoulder joints • Fluid detection: Pericardial, Pleural, Peritoneal, Amniotic, Joints • Procedures: Thoracentesis, Paracentesis, Pericardiocentesis, Amniocentesis, Arthrocentesis • Foreign body visualization/ localization • Bladder catheterization • Nerve blocks • Biopsy • Placement and monitor positio
Indications Reference Guide Table 7-4: Clinical Application Linear Array Transducer Anatomy Evaluation Small organs (Adult/ Pediatric) • Testes • Scrotum • Thyroid • Breast • Bowel • Abdominal wall • Skin • Subcutaneous tissue • Fascia • Lymph nodes • Testicular torsion (size, echo-texture and vascularity) • Epididymo-orchitis • Fluid collection in scrotal sac • Hematomas, hernias • Breast nodules, mass, cyst • Abdominal wall masses, hernias • Thyroid nodules/cyst/mass/ diffuse enlargement • Bowel pat
Appendix Table 7-4: Clinical Application Linear Array Transducer Anatomy Evaluation Procedural guidance (Adult/ Pediatrics) • Thorax • Veins (including Jugular/ Subclavian/ Axillary/ Femoral / Brachial/ Basilic/ Cephalic) • Arteries (including femoral, radial, brachial, axillary, dorsalis pedis) • Peripheral nerves • Joints • Vertebral spaces • Skin and subcutaneous tissue • Trachea and surrounding structures • Fluid detection and removal support: thoracentesis • Peripheral venous access • Central ven
Index A R About, 4-34 accessories ordering, 1-13 requesting a catalog, 1-13 Appendix, 7-1 Regulatory Requirements, i-6 Review and recall of stored data, 5-46 B Battery, 3-13 Charge, 3-13 specifications, 3-17 Battery level indicator, 3-15 C Cleaning and disinfection, 6-4 Color Aliasing, 5-22 Configuration, 4-3 Contact Information, 1-13 contacts clinical questions, 1-13 Internet, 1-13 service questions, 1-13 S Safety Acoustic output, 2-16 Device labels and symbols, 2-24 Electromagnetic Compatibility (E
Index-2 Vscan Air – User Manual Direction GP092020-1EN Rev 08
