GE Vscan Air Manual

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Vscan Air

User Manual

H45611AK

GP092020-1EN - English

Rev 18

Operating Documentation

Table of Contents

Summary of Contents for GE Vscan Air

Page 2 This product complies with regulatory requirements of the following European Directive 93/42/EEC concerning medical devices. Vscan Air CL A1, Vscan Air CL A2, Vscan Air CL C1, Vscan Air CL I1 and Vscan Air CL G1. This manual is a reference for all 1.X software versions of Vscan Air for Android and all 1.X software versions of Vscan Air for iOS.
Page 3 - Updated Table 3-2: International AC Adapter - Updated the section : Vscan Air App Version - Updated Figure 3-8. Power plugs - Updated new devices: Vscan Air - Compatible Display Devices Rev 17 15 Feb 2022 Page i-6: Added - Authorized Swiss Representative Chapter 1: - Updated Contact information: Table 1-7: Europe, Middle East &...
Page 4 (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.
Page 5 This page intentionally left blank. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 6 Regulatory Requirements Conformance Standards The GE Healthcare (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. Ignoring this advice may compromise the regulatory approvals obtained for the product.
Page 7 2015/863/EU Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (RoHS 3). * including national deviations – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 8: Authorized Swiss Representative
• 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.
Page 9: Type Bf Applied Part
Table i-2: Leakage current Normal condition Single fault condition Total Patient leakage current <500 microA <1000 microA Original documentation • The original document was written in English. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 10: Country Specific Approval
32nd Floor, Thanapoom Tower 1550 New Petchburi Road Makkasan, Ratthewi, Bangkok 10400, Thailand Tel: (+66) 2 624 8488 Indonesia Diimpor oleh PT GE Operations Indonesia, Jakarta – Indonesia KEMENKES RI, AKL 21501124385 Malaysia Registration Number: GB2527121-66060 GE Healthcare SDN BHD...
Page 11 INFORMAÇÕES DO PRODUTO E DO REGISTRO ANVISA NOME DO PRODUTO: Equipamentos de Ultrassom MODELO: Vscan Air CL CONTEÚDO DA EMBALAGEM: 01 Vscan Air CL, Instrução de uso, partes e acessórios. REGISTRO ANVISA N°: 80071260411 RESPONSÁVEL TÉCNICO: Karolina Morangoni Torres – Registro CREA/SP n° 5069785521 FABRICANTE LEGAL: GE VINGMED ULTRASOUND AS INFORMAÇÕES DO IMPORTADOR E DISTRIBUIDOR...
Page 12 INFORMAÇÕES DO PRODUTO E DO REGISTRO ANVISA NOME DO PRODUTO: Software MODELO: Vscan Air app CONTEÚDO DA EMBALAGEM: 01 Vscan Air app, Instrução de uso, partes e acessórios. REGISTRO ANVISA N°: 80071260434 RESPONSÁVEL TÉCNICO: Karolina Morangoni Torres – Registro CREA/SP n° 5069785521 FABRICANTE LEGAL: GE VINGMED ULTRASOUND AS INFORMAÇÕES DO IMPORTADOR E DISTRIBUIDOR...
Page 13 FCC ID: YOM-VSCANAIR • Canada IC: 9136A-VSCANAIR Steps to access FCC ID and IC ID • To access FCC ID and IC ID information, select Menu icon on Vscan Air app. • Press About and select Regulatory. – i-11 Vscan Air...
Page 14 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 15: Table Of Contents
Personnel and equipment safety - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-5 – i-13 Vscan Air User Manual Direction GP092020-1EN Rev 17...
Page 16 Power ON/OFF- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-31 Vscan Air App Version - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Activation and Registration - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Chapter 4 —...
Page 17 Upgrade software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20 Vscan Air CL probe software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-20...
Page 18 System Protection Vscan Air – system protection - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-8 Host OS and other host software negative compatibility - - - - - - - - - - - - 7-8...
Page 19 Chapter 1 Introduction Contents: ‘Overview’ on page 1-2 ‘Warnings’ on page 1-10 ‘Contact Information’ on page 1-12 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 20: Overview
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. Please contact your local GE representative to get the latest information. NOTE:...
Page 21 1. Vscan Air software application (app): • Vscan Air for iOS • Vscan Air for Android 2. Vscan Air CL probe The table below lists the Vscan Air CL configurations covered by this manual: Table 1-1: Vscan Air CL configurations Vscan Air CL Part Item...
Page 22: Naming Conventions
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. The terms Vscan Air ultrasound system, Vscan Air ultrasound device or Vscan Air solution are used to refer to the Vscan Air product consisting of the probe and the app.
Page 23: Wireless Description
A probe is an accurate, solid-state device, providing multiple image formats. The digital design and use of solid-state components provides highly stable and consistent imaging performance with minimal required maintenance. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 24: Safety
Intended use Vscan Air is a software application on a mobile phone or tablet to be used with a Vscan Air probe. The Vscan Air app is intended for diagnostic ultrasound examinations, image guidance and for measurements of anatomical structures and fluid.
Page 25 (includes free hand needle/catheter placement, fluid drainage, nerve block, vascular access and biopsy). Table 1-3: Supported imaging modes Black/white Color flow Combined (B+ Vscan Air imaging (B-mode) (Color doppler) color doppler) Harmonics Curved array transducer Linear array transducer •...
Page 26: Contraindications For Use
Introduction Contraindications for use The Vscan Air diagnostic ultrasound system is not intended for WARNING use with contrast agents. Clinical application not cleared for use in Japan NOTE: Vscan Air diagnostic ultrasound system does not hold regulatory clearance in Japan for Ophthalmic use.
Page 27: Prescription Device
Vscan web portal for reference materials. Prescription Device For USA only: Federal law restricts this device to sale by or on the order of a CAUTION physician or other authorized licensed healthcare practitioner. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 28: Warnings
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. •...
Page 29 • Before charging the Vscan Air probe it is important to be aware of the Environmental requirements for Vscan Air CL (refer ‘Environmental requirements’ on page 3-8) and to read and understand information given in the Vscan Air Battery section (refer ‘Vscan Air Battery’...
Page 30: Contact Information
For service in the United States, call GE CARES. TEL: (1) 800-437-1171 In other locations, contact your local Service Representative. Keep the serial number printed on your Vscan Air probe easily available when contacting service. Information To request technical product information in the United States, Requests call GEHC.
Page 31 Demais localidades CANADA TEL: (1) 800-668-0732 Customer Answer Center TEL: (1) 905-412-3213 When contacting GEHC CARES for your Vscan Air, you will need to provide the serial number printed on your Vscan Air probe. LATIN & SOUTH TEL: (1) 262-524-5300...
Page 32 TEL: 0800-5-4342 CHILE TEL: 1888-0020-4342, 800204302 TEL: (1) 800-437-1171 FAX: (1) 414-721-3865 When contacting GEHC CARES for your Vscan Air, you will need to provide the serial number printed on your Vscan Air probe. Table 1-6: Asia ASIA PACIFIC TEL: +81 42 585 5111...
Page 33 TEL: 0040311305293/ callcenterro@ge.com; ana-maria.gindea@ge.com VIP: 0040 311 305 099/ Affidea: 0040 311 305 FAX: (+40) 372074699 BULGARIA Sofia TEL: 00359 2 971 2040 - Iva.Ilieva@ge.com , Nikoleta.Lulcheva@ge.com Office 00359 080018170 - Call Center FAX- +359 2 8704002 SERBIA Belgrade 00381 112200791 marina.jankovic@ge.com...
Page 34 800917293 Centre TEL: 0039 800 827 168 South ISRAEL Haifa TEL: 00972-4-858-2929 revital.sassu@ge.com FAX: 00972-4-858-0969 KAZAKHSTAN TEL: +7 727 3560020 TEL: 88000700770 FAX: +77273568544 Alma-Aty 88000700770@ge.com LUXEMBORG See Belgium. 1-16 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 35 TEL: 0034 902 400 246 GEHealthcareServiceCenterIberia@ge.com SWEDEN TEL: (+46) 08 559 500 10 FAX: (+46) 08 559 500 15 Service Center 0046 201201436 SWITZERLAND TEL: 0800 556 958 FAX: (+41)-44 809 9231 ce.switzerland.sc@ge.com – 1-17 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 36: Manufacturer
For all other European countries not listed, please contact your local GEHC distributor or the appropriate support resource listed on www.gehealthcare.com. Manufacturer GE VINGMED ULTRASOUND AS Strandpromenaden 45 3191 Horten, Norway TEL: (+47) 3302 1100; FAX: (+47) 3302 1350 1-18 –...
Page 37 Chapter 2 Safety Contents: ‘Introduction’ on page 2-2 ‘Owner responsibility’ on page 2-3 ‘Important safety considerations’ on page 2-4 ‘Maximum probe temperature’ on page 2-24 ‘Device labels and symbols’ on page 2-25 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 38: Introduction
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...
Page 39: Owner Responsibility
It is advisable to maintain a list of authorized operators. Should the system fail to operate correctly, or if Vscan Air does not respond to the commands described in this manual, the operator should contact the nearest GEHC ultrasound service office.
Page 40 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.
Page 41: Important Safety Considerations
Equipment malfunction or incorrect settings can result in measurement errors or failure to detect details in the image. The user must become thoroughly familiar with the operation of the Vscan Air to optimize its performance and to recognize possible malfunctions. Avoid reflections from windows/lamps/direct sunlight on the CAUTION display.
Page 42: Explosion Hazard
• If flammable substances are detected after the device has been turned on, do not attempt to turn off the Vscan Air CL, or to unplug it. • If flammable substances are detected, evacuate and ventilate the area before turning off Vscan Air CL.
Page 43: Electrical Safety
Vscan Air CL probe is an internally powered device, type BF. The AC adapter is Class II. External connection Charging of Vscan Air CL via the AC adapter and the wireless CAUTION charger pad must be kept outside the patient environment (refer to local regulation and EN/ES/IEC 60601-1).
Page 44: Electromagnetic Compatibility (Emc)
For more details regarding allergic reaction to latex, refer to FDA Medical Alert MDA91-1, March 29 1991. The Vscan Air CL probe does not contain latex. Contact with natural rubber latex may cause a severe CAUTION anaphylactic reaction in persons sensitive to the natural latex protein.
Page 45 Medical staff in charge of the device are required to instruct technicians, patients, and other people who may be around the device to fully comply with the above recommendations. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 46 Vscan Air CL probe. The Vscan Air CL probe should not be used adjacent or very WARNING close to other equipment. The Vscan Air should be observed to verify normal device behavior in the configuration in which it will be used.
Page 47 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. – 2-11 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 48 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. Other faces of the probe (front, rear, left side and right side) are intended to be used by hand.
Page 49: Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions. 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.
Page 50: Electromagnetic Immunity
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.
Page 51 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.
Page 52 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.
Page 53: Essential Performance
Important safety considerations 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.
Page 54 MI and TI values are displayed on the scanning screen. The display resolution of MI and TI is 0.1. The maximum possible MI and Ispta on the Vscan Air CL is within the limits set in Track 3 in the FDA guidance of June 27, 2019 for diagnostic ultrasound systems and transducers, MI <1.9 and Ispta <720 mW/cm...
Page 55 The operator should aim to stay within the BMUS recommended scan times (especially for obstetric examinations). • Scans in pregnancy should not be carried out for the sole purpose of producing souvenir videos or photographs. – 2-19 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 56 Further guidance on the safe use of obstetric ultrasound can be found in the Official statements of the American Institute of Ultrasound in Medicine (AIUM) – “Prudent Use and Safety of Diagnostic Ultrasound in Pregnancy.” 2-20 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 57 Acoustic output depends on the imaging mode selected. This greatly affects the energy absorbed by the tissue, as described in ‘Black/white imaging (B-mode)’ on page 5-16 and ‘Color flow (Color Doppler)’ on page 5-24. – 2-21 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 58 ALARA training is provided in the Medical Ultrasound Safety booklet, published by AIUM (American Institute of Ultrasound in Medicine). This booklet is provided with the Vscan Air CL to customers in USA. The ALARA education program for the clinical end-user covers basic ultrasound principles, possible...
Page 59: Environmental Protection
The equipment must not be disposed as unsorted municipal waste nor be destroyed by incineration. It must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment. – 2-23 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 60: Maximum Probe Temperature
33°C. Maximum Vscan Air CL temperature (Simulated use) is <43°C. • With Vscan Air CL transmitting in air, temperature rise is measured and added to 23°C. Maximum Vscan Air CL temperature (Still air) is <50°C. Lens temperature is monitored for 30 minutes.
Page 61: Device Labels And Symbols
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 –...
Page 62 Safety Vscan Air labels (continued) 1. Vscan Air for Android rating label 2. Vscan Air for iOS rating label Figure 2-3. Vscan Air app rating label versions 2-26 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 63 Device labels and symbols Vscan Air labels (continued) Figure 2-4. Adapter label Figure 2-5. Battery label NOTE: The adapters and labels shown in Figure 2-2, Figure 2-3, Figure 2-4 and Figure 2-5 are samples. The adapter color may be different and the label content may vary based on country requirements and product configuration.
Page 64 Indicates the temperature limits to Vscan Air CL probe ISO 7000-0632 which the medical device can be safely exposed. For Vscan Air the temperature range is relating to continuous environmental operating conditions. Prescription device statement for the - Vscan Air app...
Page 65 Table 2-8: Label Icons Label Purpose Location Standard Manufacturer name and address - Vscan Air CL probe ISO 7000-3082 - Vscan Air app Manufacturing date (year-month) - Vscan Air CL probe ISO 7000-2497 - Vscan Air app Brand and model identifier.
Page 66 Australia / New Zealand NOTE: The label content for the Vscan Air probe, the Vscan Air app and the Vscan Air packaging will vary based on country requirements and configuration. Symbols or icons available for a recently manufactured device might differ if comparing to an earlier manufactured device of the same model.
Page 67: For China Only
EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste and must be collected separately and handled properly after decommissioning. – 2-31 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 68 • Applications of hazardous substances in this medical device are required to achieve its intended clinical uses, and/or to provide better protection to human beings and/or to environment, due to lack of reasonably (economically or technically) available substitutes. 2-32 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 69 Contents: ‘Package contents’ on page 3-2 ‘Environmental requirements’ on page 3-8 ‘System description’ on page 3-10 ‘Accessories’ on page 3-16 ‘Vscan Air Battery’ on page 3-17 ‘Initial use’ on page 3-24 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 70: Chapter 3 - Preparing Vscan Air Cl For Use
7. AC adapter (plug type varies based on 4. Product Box with Protective Case region and model) Figure 3-1. Vscan Air CL product box contents NOTE: The Protective case protects the Vscan Air CL from scratches when it is not being used. – Vscan Air User Manual...
Page 71 3. Package contents with PowerWave Pad and USB cable 4. Unboxing of the Contents 5. USB cable (1.2m) 6. Anker PowerWave charging pad Figure 3-2. Anker PowerWave charging pad package contents – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 72 Vscan Air probe will not start unless an initial charging cycle has been initiated. 2. To turn ON the Vscan Air CL, press and hold the power button for 1 second. 3. Plug one end of the USB cable into the wireless charging Pad and the other into the AC adapter.
Page 73 How to charge the Vscan Air CL (continued) 4. Connect the AC adapter into the wall outlet. 5. Place the Vscan Air CL on the charging pad with the GE logo up. Ensure the probe is centered on the charging pad.
Page 74 Whenever charge is less than 8% and probe needs a higher charge level to allow starting. Yellow light on both LEDs indicates the Vscan Air CL is charging with capacity in the range 8-90%. Green light on both LEDs indicates the Vscan Air CL is fully charged 90-100% (see ‘Vscan Air CL LED indication’...
Page 75 How to charge the Vscan Air CL (continued) NOTE: The Vscan Air CL will charge while being powered off. If the probe is placed onto the charging pad while being turned on it will Initiate a shutdown within 30 seconds after detecting that charging has started.
Page 76: Environmental Requirements
‘Cleaning and disinfection’ on page 6-6. Image on the display device hosting the Vscan Air app is dependent on ambient light; avoid direct sunlight or reflections from other light sources on the display when scanning and reviewing images.
Page 77 The Vscan Air ultrasound system can be used in an emergency medical services environment, including road** and air ambulances*. • The Vscan Air CL is not certified for being mounted or fixed inside a road- or air ambulance. • The Vscan Air CL can be used in emergency medical services environments.
Page 78: 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...
Page 79: Display Screens
1. Wireless connection quality indicator 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. – 3-11 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 80 Preparing Vscan Air CL for Use Wireless connection quality indicator (continued) The ‘Wireless connection quality indicator’ provides a visual indication of the connection quality between the probe and the app during scanning. An unstable connection may result in loss of image quality or slow image update during real time imaging.
Page 81 System description Probe temperature indicator and thermal management (continued) The thermal management system of Vscan Air CL automatically reduces some parameters such as frame rates or image width to keep the probe temperature within optimal functional levels to support continuous scans up to 50 minutes*.
Page 82 Preparing Vscan Air CL for Use Probe temperature indicator and thermal management (continued) 1. Level 3 2. Level 4 Figure 3-5. Thermal indicator toast message Figure 3-6. Thermal warning message 3-14 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 83 Curved array (deep scanning) transducer Linear array (shallow scanning) transducer 1. Image orientation marker 1. Image orientation marker 2. Vscan Air battery status indicator 2. Vscan Air battery status indicator 3. Probe link quality indicator 3. Probe link quality indicator 4.
Page 84: Accessories
Preparing Vscan Air CL for Use Accessories Optional accessories Table 3-2: International AC Adapter Accessory Figure AC Adapter - Type C AC Adapter - Type G AC Adapter - Type A AC Adapter - Type I NOTE: Details about types of AC power plugs are included in ‘Power plugs’...
Page 85: Vscan Air Battery
Vscan Air 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.
Page 86 CAUTION range can cause a malfunction or destroy the AC adapter. Charging the battery 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 3-18 –...
Page 87 Vscan Air Battery Battery level indicator The Vscan Air 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: Battery level indicator Icon...
Page 88 CL is ON and searching for Vscan Air App. - A steady white light on both LEDs indicates that the Vscan Air CL is ON and a display device with the Vscan Air App is found. - A steady blue light on both LEDs indicates that the Vscan Air CL is ON and connected.
Page 89 Vscan Air Battery Vscan Air CL is OFF A short press (<1 sec) on the power button while the Vscan Air CL probe is off will show the battery charge status via the LED lights. 1. Battery level 8-90% 2. Fully charged Figure 3-10.
Page 90 - A steady orange/red toned yellow on both LEDs indicates the Vscan Air CL is charging. Charge level is less than 8%, and probe will need to charge above this level to be powered on. - A steady yellow light on both LEDs indicates the Vscan Air CL is charging.
Page 91 50 minutes continuous scan (see Note) Lifetime At least 500 charges In order to get maximum charging capacity with your Vscan Air battery, you should initially allow the battery to be fully charged and then fully discharged at least three times. Perform normal operation during these cycles.
Page 92: Initial Use
- Data on device must be encrypted and authentication enabled NOTE: Using the Vscan Air app with a mobile device which does not meet the minimum requirements may result in low-quality images, unexpected results, and possible misdiagnosis. The Vscan Air app may not work on all devices.
Page 93 Initial use Vscan Air - Compatible Display Devices Please visit the Vscan Air support center to access the most recent list of validated display devices. http://vscanair-support.gehealthcare.com/ Vscan Air App iOS has been validated for the following display devices: Apple iPhones:...
Page 94 Preparing Vscan Air CL for Use Vscan Air - Compatible Display Devices (continued) Apple iPads: Device Operating system iPad Pro 5th Gen iPadOS 15 iPadOS 14 iPad Pro 4th Gen iPadOS 14.4 iPadOS 13.7 iPad Mini 6th Gen iPadOS 15.1 iPad Mini 5th Gen iPadOS 15.0...
Page 95 Initial use Vscan Air - Compatible Display Devices (continued) The Vscan Air App for Android has been validated for the following display devices: Samsung Mobile: Device Operating system Samsung Galaxy S22 Ultra Android 12 Samsung Galaxy S22+ Android 12 Samsung Galaxy S22 Android 12 Samsung Galaxy S21 Ultra (Intl.)
Page 96 NOTE: Device and OS combinations not listed have not been verified for compatibility with Vscan Air. OS point releases higher than the release listed for your device (also known as maintenance releases) are compatible but have not been explicitly verified for the device.
Page 97 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. – 3-29 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 98 Preparing Vscan Air CL for Use Display device image quality verification (continued) Recommended example images: Abdominal preset on Curved and MSK preset on Linear transducer. Figure 3-13. Screen with preview mode Figure 3-14. Abdominal preset with curved 3-30 – Vscan Air...
Page 99: Power On/Off
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 100: Vscan Air App Version
This is an example of the display format for App Version/ Revision. 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.
Page 101 Initial use Create a Vscan Air user account 1. Click on the Vscan Air app icon on the display device to start the app. 2. Press Register to start registration Figure 3-16. Start registration – 3-33 Vscan Air User Manual...
Page 102 Preparing Vscan Air CL for Use Create a Vscan Air user account (continued) NOTE: The Vscan Air app can be explored by selecting “Preview”. In this mode, scanning is disabled. 3. Select “Create new account” on “SIGN IN” screen. Figure 3-17. Register the Vscan Air app...
Page 103 Initial use Create a Vscan Air user account (continued) If a registered account is already found for the email entered, the app will return to the previous screen to sign in using the existing credentials. If an existing account is not found for the entered email, you will be taken to the next step.
Page 104 4. Turn on Vscan Air CL. Figure 3-19. Search for Vscan Air CL 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'.
Page 105 Initial use Create a Vscan Air user account (continued) 5. Wait for initialization of Vscan Air CL. Figure 3-20. Initialization of Vscan Air CL – 3-37 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 106 Preparing Vscan Air CL for Use Create a Vscan Air user account (continued) 6. Press the power button on Vscan Air CL to connect to the Vscan Air app. Figure 3-21. Connect to Display 3-38 – Vscan Air User Manual...
Page 107 Initial use Create a Vscan Air user account (continued) 7. Once Vscan Air CL is found, select “Continue registration”. Figure 3-22. Vscan Air CL Detected 8. Enter the required information. NOTE: The password must be at least 8 characters long and should have a mix of letters and numbers.
Page 108 Preparing Vscan Air CL for Use Create a Vscan Air user account (continued) 10. Acknowledge Terms and Conditions related to user accounts and check desired options to either participate in collaborative GEHC activities or to receive special offers and promotions.
Page 109 Initial use Create a Vscan Air user account (continued) 12. An email is sent to your email address to validate the Vscan Air user account. Figure 3-24. Confirm email NOTE: Please check your spam folder if you do not receive the email to validate your account.
Page 110 Preparing Vscan Air CL for Use Create a Vscan Air user account (continued) 13. The following activation email will be sent to the registered email. Figure 3-25. Email message NOTE: Email shows example URL. 3-42 – Vscan Air User Manual...
Page 111 Initial use Create a Vscan Air user account (continued) 14. Click the link in the email to validate the Vscan Air user account. 15. The account is activated. Sign into the new account. Figure 3-26. Sign in to the account...
Page 112 Create a Vscan Air user account (continued) 16. If the account is not activated by clicking the activation link, Vscan Air application will display a warning message. In such scenario, press “Click here” to initiate request for resending the activation email from the sign in screen.
Page 113 Initial use Create a Vscan Air user account (continued) 17. Once email is validated, the app screen will show registration details. Click Confirm to proceed. Figure 3-28. Confirm registration details – 3-45 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 114 Preparing Vscan Air CL for Use Create a Vscan Air user account (continued) 18. 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 3-29. Registration complete 3-46 –...
Page 115 Initial use Create a Vscan Air user account (continued) 19. To add a security PIN code after completing Vscan Air registration, see ‘Add security PIN (data access PIN)’ on page 3-76 for more information. 20. The Vscan Air CL is now connected to the app.
Page 116 Create a Vscan Air user account (continued) NOTE: When the Wi-Fi connection to the paired probe is unexpectedly lost, the Vscan Air App shows the below warning message as 'Lost connection to Probe'. Figure 3-31. Vscan Air CL Connection Lost 3-48 –...
Page 117 Initial use New Vscan Air app registration using an existing account Use the below steps to register the Vscan Air app on a different display device using your existing Vscan Air account. 1. Press Register to start registration. Figure 3-32. Welcome screen NOTE: The app can be explored by selecting ‘Preview’.
Page 118 Preparing Vscan Air CL for Use New Vscan Air app registration using an existing account (continued) 2. Enter the email address and password for your existing Vscan Air account. Figure 3-33. Sign in to the Vscan Air account 3-50 –...
Page 119 Initial use New Vscan Air app registration using an existing account (continued) 3. Confirm that registration details are correct or edit if needed. Figure 3-34. Confirm registration – 3-51 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 120 Preparing Vscan Air CL for Use New Vscan Air app registration using an existing account (continued) 4. On confirmation the registration completion screen is displayed. Figure 3-35. Registration complete 3-52 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 121 Initial use New Vscan Air app registration using an existing account (continued) 5. If your user account was created using the "Add user" feature (refer ‘Adding users’ on page 3-63), where all the fields needed for device registration are not captured, then the registration screen will be displayed to update the remaining mandatory fields.
Page 122 Preparing Vscan Air CL for Use New Vscan Air CL probe registration using existing account 1. Open Vscan Air app. 2. Select Add a new probe. Figure 3-37. Search for Vscan Air CL probe 3-54 – Vscan Air User Manual...
Page 123 Initial use New Vscan Air CL probe registration using existing account (continued) 3. If not already turned on, turn on Vscan Air CL probe now. Figure 3-38. Turn On Vscan Air CL probe – 3-55 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 124 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 3-39. Initialization of Vscan Air CL 3-56 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 125 Initial use New Vscan Air CL probe registration using existing account (continued) 5. Press the power button on Vscan Air CL to connect to the Vscan Air app. Figure 3-40. Connect to display NOTE: When Vscan Air CL is connected to an iOS display device, other Wi-Fi connections will be disconnected.
Page 126 Preparing Vscan Air CL for 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 3-41. Vscan Air CL detected 3-58 –...
Page 127 Initial use New Vscan Air CL probe registration using existing account (continued) 7. Confirm that registration details are correct or edit if needed. Figure 3-42. Confirm registration – 3-59 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 128 Preparing Vscan Air CL for Use New Vscan Air CL probe registration using existing account (continued) Figure 3-43. Registration complete 3-60 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 129 Initial use New Vscan Air CL probe registration using existing account (continued) 8. Registration is complete. Press Start scanning to begin using your Vscan Air CL device. Figure 3-44. Vscan Air CL activation – 3-61 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 130 Preparing Vscan Air CL for Use New Vscan Air CL probe registration using existing account (continued) 9. When the scanning is over switch off the probe. The Vscan Air app on screen displays the message 'Probe is shutting down". Figure 3-45. Probe shutting down 3-62 –...
Page 131 New users can be added to use a registered application. 1. To add a new user on the sign in page of a registered application, click on Add User button. Figure 3-46. Add new user – 3-63 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 132 Preparing Vscan Air CL for Use Adding users (continued) 2. Enter the users email address on the registration screen. If the email is found to be already registered, user will be taken to the previous screen to sign in using the existing account credentials.
Page 133 Initial use Adding users (continued) 3. If the entered email is not yet registered, user will be taken to user registration screen. Figure 3-48. User registration – 3-65 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 134 Please check your spam folder if you do not receive the email to validate your account. Figure 3-49. Email Validation 5. Click on the link in the email to validate the Vscan Air user account. Confirm registration details. Registration is complete and user can go to the scan screen by clicking Start Scanning button.
Page 135 Guest mode. NOTE: Scanning in Guest mode is supported only for previously registered probes and apps. 1. To scan without signing in, click the Guest button. Figure 3-50. Scan as Guest – 3-67 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 136 Preparing Vscan Air CL for Use Scan without signing in - Guest (continued) 2. Edit Patient button is disabled for guest users under the current exam review screen. Users are required to sign in to add patient details. Figure 3-51. Current exam review screen 3-68 –...
Page 137 3. To exist Guest mode, click on the exit button on the top right corner of the left panel menu. 1. Sign out / Exit icon Figure 3-52. Exit Guest mode – 3-69 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 138 Preparing Vscan Air CL for Use User sign in / sign out 1. Registered users can sign in and sign out from Vscan Air application. Sign in by entering valid credentials on the sign in page. If the entered credentials are incorrect, the application will show an error message.
Page 139 1. User initials - signed in user 2. User email - signed in user 3. Sign out/Exit Figure 3-54. Signed in user, displayed in the top of the left panel – 3-71 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 140 Preparing Vscan Air CL for Use User sign in / sign out (continued) 5. User will be taken back to the sign in screen on successful sign out. Figure 3-55. Sign in screen NOTE: An automatic sign out duration configuration setting is available.
Page 141 Initial use Delete User Accounts To delete Vscan Air app user account, follow the below steps: 1. Sign in by entering valid credentials on the sign in page. Figure 3-56. Sign in screen 2. The user initials, which is the first letter of the first and last name of the signed in user, will be displayed at the top left corner of the left panel menu screen.
Page 142 Preparing Vscan Air CL for Use Delete User Accounts (continued) 3. Tap on the top left corner of menu to display the User account menu which shows Delete User Account Option. Figure 3-57. Delete user account 4. When clicked on delete user option, it navigates to the web portal which will facilitate the delete user account workflow.
Page 143 Security Exam Information/Patient Information can be protected by enabling a data access PIN. NOTE: If uninstalling the Vscan Air app from the display device, the app data, including all exam data including the images and videos will be deleted. NOTE: If unregistering the Vscan Air app from the display all exam data including the images and videos will be deleted.
Page 144 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. From Registration Details screen, Press Add security PIN button.
Page 145 Please make sure to use a strong PIN and avoid using PIN codes that are easy to guess. NOTE: If entering an incorrect PIN 10 times in a row all exam data including the images and videos will be deleted. – 3-77 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 146 Preparing Vscan Air CL for Use Add security PIN (data access PIN) (continued) 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.
Page 147 If you wish to use Vscan Air CL A, turn off Vscan Air CL B or put it far away from the display device. Press the power button on Vscan Air CL probe to connect to the Vscan Air app.
Page 148 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...
Page 149 Initial use Unregister Vscan Air Probe To Unregister Vscan Air Probe, follow the procedure below: 1. Press Menu -> About -> Registered devices Figure 3-61. Registered devices 2. Press Unregister button on “Connected probe” tab on Registered devices screen to Unregister Vscan Air Probe.
Page 150 Figure 3-63. Unregister app warning NOTE: It is important to unregister the Vscan Air if a new person will be taking over the ownership of the probe. The new person will be required to register the probe before starting to use it and will be the new owner of the device.
Page 151 Initial use Unregister Vscan Air app To Unregister Vscan Air app, follow the procedure below: 1. Press Menu -> About -> Registered devices Figure 3-64. Registered devices 2. Press Unregister button on “App on this device” tab on Registered devices screen to Unregister Vscan Air app.
Page 152 Figure 3-67. Erase data NOTE: It is important to unregister the Vscan Air app if a new person will be taking over the ownership of the app.The new person will be required to register the app before starting to use it and will be the new owner of the device.
Page 153: Configuration
Chapter 4 Vscan Air Configuration (for iOS and Android) Contents: ‘Configuration’ on page 4-2 ‘User account’ on page 4-44 ‘Support’ on page 4-46 ‘Diagnostics’ on page 4-51 ‘About’ on page 4-53 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 154: Configuration
Vscan Air Configuration (for iOS and Android) Configuration The following functions are available under the main menu. 1. Configuration 2. User account 3. Support 4. Diagnostics 5. About Figure 4-1. Menu – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 155 TGC control, Cardiac Flip L/R, Auto freeze time, Video duration, Probe button action, Measurement unit, Preview mode, Store binary image data, Language, Display Calibration, Device configration, Server settings, Automatic sign out and Security. Figure 4-2. Configuration – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 156 2. Focus Marker (see ‘Configuration’ on page 4-3)- Tap the ON/OFF toggle switch to turn ON or OFF the Focus Marker. When turned ON, Vscan Air app displays the focus marker in black and white, color imaging, in freeze mode and during replay.
Page 157 Flip Left Right option is available for all the presets and it will have impact only when Cardiac preset is selected. The default value of this configuration is false which means it is flipped left. Figure 4-4. CLA-Cardiac (no flip) – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 158 Vscan Air Configuration (for iOS and Android) Configuration (continued) • Flip Left Right option will be available for Cardiac preset. Figure 4-5. CLA-Cardiac (flip) – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 159 Configure the display device with an adequate 'screen-save' timeout and ‘auto freeze’ timeout in the case of performing guidance procedures where there is no user interface interaction over the course of the procedure. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 160 Vscan Air Configuration (for iOS and Android) Configuration (continued) 6. Video duration (see ‘Configuration’ on page 4-3) - • 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.
Page 161 9. 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 4-10. Preview mode pop-up – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 162 Vscan Air Configuration (for iOS and Android) Configuration (continued) 10. 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...
Page 163 Configuration (continued) 11. Language (see ‘Configuration’ on page 4-3) - Choose the desired language Figure 4-12. Language Vscan Air App defaults to English if the current language CAUTION setting on the mobile device is not supported by the Vscan Air app.
Page 164 Vscan Air Configuration (for iOS and Android) Configuration (continued) 12. Display calibration (see ‘Configuration’ on page 4-3) - The images can be used to adjust the brightness level of the device, so that a full range of grey scale level is visible. It is recommended to turnoff adaptive brightness and color filters on the device.
Page 165 Follow the procedure below to configure the device. Configuration -> Device configuration. b. Enter the default values for the Device configuration (Vscan Air) on the screen to establish communication with DICOM servers. Figure 4-14. Device configuration 14. Server Settings (see ‘Configuration’ on page 4-3) - Allows to configure the Modality Worklist Server, DICOM Image Server, Network Shared Folder.
Page 166 Vscan Air Configuration (for iOS and Android) Configuration (continued) 15. Automatic sign out (see ‘Configuration’ on page 4-3) The automatic sign out setting gives user an option to control the duration of the signed in session. The default value is 24 hours. Other available options are shown below.
Page 167 Configuration Configure Modality Worklist Server Follow the procedure below to configure a new Modality Worklist Server. 1. Press Menu -> Configuration -> Server Settings. Figure 4-16. Server Settings – 4-15 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 168 Vscan Air Configuration (for iOS and Android) Configure Modality Worklist Server (continued) 2. Press Add Server in “Server Settings” screen. Figure 4-17. Add Server 4-16 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 169 If Modality Worklist Server is of Secure DICOM (TLS communication), select the check box “Secure DICOM”. See ‘Secure DICOM’ on page 5-69 for more information. Figure 4-18. Enter configuration information. – 4-17 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 170 If communication fails, check the server settings and make necessary corrections. Figure 4-19. Verify Server NOTE: Make sure that the display device hosting the Vscan Air app and the configured network folder are connected to the same network. 4-18 –...
Page 171 To select a MWL server as a favorite, tap on the respective star mark and press YES on the pop-up message screen. Figure 4-20. Worklist server as Favourite – 4-19 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 172 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 4-21. Server Settings 4-20 – Vscan Air User Manual...
Page 173 Configuration Configure DICOM Image Server (continued) 2. Press Add Server on the “Server Settings” screen. Figure 4-22. Add Server – 4-21 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 174 Vscan Air Configuration (for iOS and Android) Configure DICOM Image Server (continued) 3. On “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 the DICOM Image Server.
Page 175 If communication fails, check the server settings and make necessary corrections. Figure 4-24. DICOM Image Server NOTE: Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connected to same network. –...
Page 176 Vscan Air Configuration (for iOS and Android) 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.
Page 177 Storage server is the DICOM image server that receives and stores exam data from Vscan Air app. Commitment Server Commitment Server sends confirmation to the Vscan Air app when the Storage Server successfully receives and stores the exam data. Auto Delete While configuring a DICOM Image Server (Storage Server), if you have enabled “Auto Delete”...
Page 178 Vscan Air Configuration (for iOS and Android) Configure Network Shared Folder Follow the procedure below to configure a new Network Shared Folder. 1. Press Menu -> Configuration -> Server Settings. Figure 4-26. Server Settings 4-26 – Vscan Air User Manual...
Page 179 Configuration Configure Network Shared Folder (continued) 2. Press Add Server in “Server Settings” screen. Figure 4-27. Add Server – 4-27 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 180 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.
Page 181 If communication fails, check the server settings and make necessary corrections. Figure 4-29. Verify network shared folder NOTE: Make sure that the display device hosting the Vscan Air App and the configured network folder are connected to the same network. –...
Page 182 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.
Page 183 DICOMweb (STOW-Store over the web) protocol. Follow the procedure below to configure a new DICOM web server. 1. Press Menu -> Configuration -> Server Settings. Figure 4-31. Server settings – 4-31 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 184 Vscan Air Configuration (for iOS and Android) Configure DICOM web server (continued) 2. Press Add Server on the “Server Settings” screen. Figure 4-32. Add server 3. On “Add New Server” screen, select “DICOM web server” from the drop-down list of “Server Type” and enter the configuration information in the respective fields to add the DICOM web server.
Page 185 If communication fails, check the server settings, and make necessary corrections. Figure 4-33. DICOM web server details Once the DICOM web server is added, you will find the server name under Server Settings. – 4-33 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 186 Vscan Air Configuration (for iOS and Android) Remove Server 1. To remove a server from the configured list of servers, Press Menu -> Configuration -> Server Settings. Figure 4-34. Server Settings 4-34 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 187 Configuration Remove Server (continued) 2. Press to select the desired server that needs to be removed. Figure 4-35. List of Servers – 4-35 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 188 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 4-36. Remove Server 4-36 –...
Page 189 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.
Page 190 Vscan Air Configuration (for iOS and Android) Ask for data access PIN (continued) 2. Tap on the Ask for data access PIN button on the Security screen. Figure 4-38. Tap on the Ask for data access PIN button 3. Enter a new 6 digit PIN in the field on the “Set up data access PIN”...
Page 191 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 4-40. Confirm data access PIN – 4-39 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 192 Vscan Air Configuration (for iOS and Android) 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 4-41. Security settings 2. Tap on the TouchID for quick data access button on the Security screen to activate biometric authentication.
Page 193 Configuration 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.
Page 194 Vscan Air Configuration (for iOS and Android) Change data access PIN (continued) 2. Tap on Change data access PIN on the Security screen. Figure 4-45. Change data access PIN 3. Under the “Change data access PIN” screen, enter your existing PIN, then enter new PIN and Confirm the new PIN.
Page 195 Please make sure to use a strong PIN and avoid using PIN codes that are easy to guess. Entering an incorrect PIN Be aware that all clinical data will be erased if an incorrect PIN is entered 10 times. – 4-43 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 196: User Account
Vscan Air Configuration (for iOS and Android) User account User account The User account feature displays "Delete user" option. To delete Vscan Air app user account, tap on “User account” which directs to "Delete user." Figure 4-47. User account 4-44 –...
Page 197 User account User account deleted from Vscan Web portal A message is triggered when remote server call operation is initiated by a deleted account owner from Vscan Air application. Figure 4-48. User account does not exist – 4-45 Vscan Air...
Page 198: Support
Vscan Air Configuration (for iOS and Android) Support Support - Unregistered Vscan Air CL When unregistered to Vscan Air CL, the Support option displays - User manual, Knowledge center and Contact us. Figure 4-49. Support • User Manual - To access the e-manual in the desired language.
Page 199 Support Support - Unregistered Vscan Air CL (continued) • Knowledge center - Directs to the Vscan Air support web page that provides access to product information. • Contact us - To access list of GEHC Service Centre contact numbers Figure 4-51. Contact us –...
Page 200: Support - Registered Vscan Air Cl
App walkthrough. To registered Vscan Air CL, follow the steps below: 4. Press Main menu > Support. 5. The Vscan Air CL pairing app shows the App walkthrough option. Figure 4-52. Vscan Air CL registered 6. Click on the App walkthrough.
Page 201 Support Support - Registered Vscan Air CL (continued) 7. Select ‘Do not show again’ to close the App walkthrough details. Figure 4-53. Close App walkthrough – 4-49 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 202 Vscan Air Configuration (for iOS and Android) Support - Registered Vscan Air CL (continued) 8. The walkthrough will guide through the basic app functions. 1. Freeze the scan screen by tapping anywhere on scan area. 2. Tap on scan and move vertical to change the depth.
Page 203: Diagnostics
The Diagnostics option displays - Run diagnostics and Send log. Figure 4-55. Diagnostics • Run Diagnostics - To run all the Diagnostic tests refer the section ‘Diagnostics Test’ on page 6-37. Figure 4-56. Run Diagnostics – 4-51 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 204 Figure 4-57. 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.
Page 205: About
About About About The About option displays - Registered devices, App version info, Probe version info, Regulatory, Account information, Acknowledgements and Export audit logs. Figure 4-58. About – 4-53 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 206 2. Registered Probe Figure 4-59. 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.
Page 207 About (continued) • App version info - Displays App software version, App software revision and the unique identifier of the installed Vscan Air app. Figure 4-60. App version info (example) • Probe version info Probe version info - Displays Probe software version and Probe software revision 1.
Page 208 Vscan Air Configuration (for iOS and Android) About (continued) • Regulatory 1. Before registration 2. After registration Figure 4-62. Regulatory • Account information 1. Press the Account information tab. Figure 4-63. Account Information 4-56 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 209 About About (continued) 2. Use the existing Vscan Air user account email and password to log in. Figure 4-64. Connect to existing account 3. Update the account details if needed. Figure 4-65. Account details – 4-57 Vscan Air User Manual...
Page 210 Vscan Air Configuration (for iOS and Android) About (continued) 4. Check to confirm the given information. 5. Press Submit, to update the Account details. Figure 4-66. Account details Updated • Acknowledgements - Displays the third party software licience. Figure 4-67. Acknowledgements 4-58 –...
Page 211 About (continued) • Export audit logs - Audit log data can be stored to an internal storage destination. Refer the ‘Audit logs’ on page 5-55. Figure 4-68. Export audit logs – 4-59 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 212 Vscan Air Configuration (for iOS and Android) 4-60 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 213 ‘Review and recall of stored data’ on page 5-53 ‘Export data’ on page 5-58 ‘Using Vscan Air in home healthcare or pre-hospital emergency medical services environment’ on page 5-81 ‘Preparing for a guided procedure with Vscan Air’ on page 5-85 ‘Digital tools’ on page 5-90 – Vscan Air...
Page 214: Display Features
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’...
Page 215 • Current exam - Displays the current exam number • Exams - Displays a list of previously saved exams that can be selected to access stored images and videos. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 216: Scanning
6-6 ). Ensure that the Vscan Air CL is properly cleaned and disinfected after each use and before storing in the protective case. If any damage is found on the Vscan Air CL, do not use it. WARNING Contact GEHC service.
Page 217 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.
Page 218 Vscan Air CL operating temperature at an optimal functional level, and to ensure longer scanning time with maximum frame rate, it is recommended to hold the Vscan Air CL such that there is good contact between the device and the hand.
Page 219 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.
Page 220 Using Vscan Air CL Image crop indicator Vscan Air maximizes the image display on the screen in the portrait mode. As a result, at certain depths, image corresponding to the entire transducer width may not visible on screen in portrait mode. Image crop indicators are displayed in such cases to make the user aware of this.
Page 221 The depth can be increased until the whole width is displayed, and image crop indicators no longer appear. • Zoom and pan to visualize the edge of the image on the desired side. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 222 A new exam can be created in two ways: 1. Automatically - A new exam will be created every time the Vscan Air CL pairs successfully with the Vscan Air app and also every time the Vscan Air App is started.
Page 223 Scanning Creating a new exam (continued) NOTE: A new exam also gets created every time a Vscan Air CL connects with the app. NOTE: An exam will get saved when an image or video is stored for that exam. NOTE: The maximum number of stored exams is limited to <500.
Page 224 5-31. 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.
Page 225 4 kg) • Soft tissue Musculoskeletal superficial • Joints • Long bones • Muscles • Tendons • Ligaments Lung • Thoracic/Pleural motion • Fluid detection Neo Head Neonatal cephalic Ophthalmic Ophthalmic – 5-13 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 226 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.
Page 227 Press and hold the preset which needs to be set as default. A small white bar displays on the bottom of the preset indicating that it is set as default. 1. White Bar Figure 5-8. Preset as default – 5-15 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 228 Using Vscan Air CL 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.
Page 229 2. Move your finger to the right or left to increase or decrease gain. Figure 5-11. Gain The adjusted gain value is seen with the icon on the top of the screen. – 5-17 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 230 Using Vscan Air CL 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.
Page 231 2. Change depth per cm from 5-24 cm. Change depth per 0.5 cm from 2-5 cm. NOTE: When the screen is rotated from portrait to landscape, depth remains unchanged. – 5-19 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 232 Using Vscan Air CL Zoom and pan Pinch on the image with two fingers to zoom. To pan or move the zoomed area, slide your finger on the image in the direction where you want the zoomed area to move.
Page 233 ‘Image crop indicators’ appear on the sides where the image edge is not visualized (Refer ‘Image crop indicator’ on page 5-8). 1. Zoom indicator 2. Crop indicator Figure 5-16. Curved array transducer – 5-21 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 234 Using Vscan Air CL 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.
Page 235 ‘Resolution’ setting is selected. Depth is maintained while alternating between the two settings. 1. Resolution setting (default) 2. Penetration setting Figure 5-17. Resolution and Penetration setting – 5-23 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 236 Using Vscan Air CL 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.
Page 237 Small movements will be ignored to avoid unintentional activation of the color gain control. 2. Move your finger to the right or left outside the color ROI to increase or decrease color gain. – 5-25 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 238 Using Vscan Air CL 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.
Page 239 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.
Page 240 Using Vscan Air CL 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...
Page 241 2. Scroll to jump multiple frames. Auto freeze If Vscan Air CL is idle for a period of time, the device enters freeze mode to minimize risk of overheating and battery drainage. Press the display to unfreeze the image and continue scanning.
Page 242 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 5-22. Store still image 5-30 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 243 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 5-23. Store video – 5-31 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 244 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.
Page 245 Figure 5-25. Edit Patient NOTE: Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam. – 5-33 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 246 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 scan screen header. Figure 5-26. Scan Screen with Patient data 4. Press Patient icon to view the images/videos under current exam.
Page 247 To assign patient details manually to an existing exam in Vscan Air application, follow the procedure below. 1. Swipe from right to left. Press Patient icon on the top right corner. Figure 5-27. Patient Icon – 5-35 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 248 Using Vscan Air CL Assign Patient data manually to an existing Exam (continued) 2. Press Exams tab. Press the desired Exam for which you wish to assign Patient data. Figure 5-28. Exam Tab NOTE: Patient data can be assigned to an individual exam only.
Page 249 Figure 5-29. Edit Exam NOTE: Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam. – 5-37 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 250 Using Vscan Air CL 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 5-30. Scan Screen with Patient data 5. Press Patient icon to view the images/videos under the existing exam.
Page 251 Scanning Assign Patient data from Modality Worklist Server to the current exam Vscan Air can download and refresh a DICOM modality worklist. An exam can be linked to an existing patient pulled from the worklist, prior to exporting to the DICOM image server.
Page 252 Using Vscan Air CL Assign Patient data from Modality Worklist Server to the current exam (continued) 2. Press “Edit Patient” and then Press the symbol at top right corner of “New Patient” screen. Figure 5-32. Edit Patient 5-40 – Vscan Air...
Page 253 Make a remote search to find the details of a particular patient from selected Modality Worklist Server – by entering Patient ID in the “Patient Query” field on the screen. Figure 5-33. Search Patient – 5-41 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 254 Figure 5-34. Worklist NOTE: Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connected to same network. NOTE: When you refresh the patient details in “worklist”...
Page 255 Once the Patient data is assigned to an exam, you can not re-assign or alter the patient details in that exam. 5. Press Patient icon to view the images/videos under current exam. – 5-43 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 256 Using Vscan Air CL Assign Patient data from Modality Worklist Server to an existing exam Vscan Air can download and refresh a DICOM modality worklist. An exam can be linked to an existing patient pulled from the worklist, prior to exporting to the DICOM image server.
Page 257 Assign Patient data from Modality Worklist Server to an existing exam (continued) 2. Press Exams tab. Press the desired Exam for which you wish to assign Patient data. Figure 5-37. Exam tab – 5-45 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 258 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 5-38. Edit Patient 5-46 – Vscan Air...
Page 259 Make a remote search to find the details of a particular patient from selected Modality Worklist Server – by entering Patient ID in the “Patient Query” field on the screen. Figure 5-39. Search patient – 5-47 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 260 Figure 5-40. Worklist NOTE: Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connected to same network. NOTE: When you refresh the patient details in “worklist”...
Page 261 Once the Patient data is assigned to an exam, you cannot re-assign or alter the patient details in that exam. 6. Press Patient icon to view the images/videos under the existing exam. – 5-49 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 262: 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.
Page 263 1. On a frozen image, press the ‘Measure’ button. Select the ellipse icon to change the measurement type from 'Distance' to 'Ellipse. The measurement calipers displays. Figure 5-43. Select Ellipse measurement – 5-51 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 264 Using Vscan Air CL Taking measurements (continued) 2. Drag to position the calipers to obtain the desired measurement. 3. To store the image with a measurement, press store. NOTE: Only a single ellipse measurement can be performed on the displayed image.
Page 265: Review And Recall Of Stored Data
1. Image orientation marker 2. Recalled image preset icon 3. Recalled image exam number 4. Recalled image depth 5. Recalled image preset 6. Recalled image date and time Figure 5-44. Recalled stored image – 5-53 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 266 Using Vscan Air CL Review Saved Exams 1. Swipe from right to left. Tap on Patient icon on the top right corner. 2. Tap Exams on top tab. Saved exams will be shown in a list. Most recent exams are shown on top.
Page 267: Audit Logs
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.
Page 268 Using Vscan Air CL Audit logs (continued) Figure 5-46. Export audit log NOTE: When storing the audit log file using an Android device the user will be given the option to choose the path and edit the file name before storing the file. This can be utilized to avoid overwriting the old audit log file.
Page 269 When the folder is refreshed (closed and opened again) the latest file will be displayed. Figure 5-48. iOS audit log export – 5-57 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 270: Export Data
The maximum number of stored exams is limited to <500. The Vscan Air app will inform the user to export and/or delete exams as needed once the number of stored exams are 480 or higher.
Page 271: Share Individual Images/Videos
1. Swipe from right to left. Press Patient icon button on the top right corner. A list of stored images or videos for the current exam display. Figure 5-49. Current exam images/videos – 5-59 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 272 Using Vscan Air CL Share individual images/videos (continued) 2. Select the desired exam or video you wish to share. 1. Select one OR 2. Select all Figure 5-50. Select desired Exam 5-60 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 273 Export data Share individual images/videos (continued) 3. Press Share icon. Figure 5-51. Share with other apps – 5-61 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 274: Share All Images/Videos From An Exam
Using Vscan Air CL Share individual images/videos (continued) 4. Choose the Share function on your display device to share the images/videos. Figure 5-52. Select app Share all images/videos from an exam In the same way as illustrated in the Share individual images/ videos section it is also possible to select and share Exams.
Page 275: Export Data To The Dicom Image Server
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 a configured DICOM image server, follow the procedure below. 1. Swipe from right to left.
Page 276 Using Vscan Air CL 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 5-54. Exams Tab 5-64 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 277 Select the desired single/multiple exams you wish to export from Exams list and Press the Share icon. See ‘Share Exams’ on page 5-63 for more information. Figure 5-55. Select Images/Videos – 5-65 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 278 Using Vscan Air CL 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.
Page 279 In addition to image queue you can also view export status for each image/video/ exam, where a green dot indicates it is successfully exported and a red dot indicates the export is failed. Figure 5-57. Image Queue – 5-67 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 280 Using Vscan Air CL 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.
Page 281: Secure Dicom
You can get a certificate from your system administrator or download it from sites that require authentication. To enable Secure DICOM in the Vscan Air app, follow the procedure below: 1. While configuring DICOM Image Server or Modality Worklist Server, to enable Secure DICOM, select the check box Secure DICOM on “Add New Server”...
Page 282 Using Vscan Air CL Secure DICOM (continued) 2. Under Secure DICOM select the desired Security Profile. Figure 5-60. Select Security Profile 5-70 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 283 Export data Secure DICOM (continued) 3. Press the Add Server Certificate button, to upload the server certificate. Figure 5-61. Add Server Certificate – 5-71 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 284 Using Vscan Air CL Secure DICOM (continued) 4. Press the Add Client Certificate button, to upload the Client certificate. Figure 5-62. Upload Client Certificate 5-72 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 285 Secure DICOM (continued) 5. Press the Add Client Key button, to upload the Client Key. Figure 5-63. Upload Client Key 6. After successful uploading of the certificates, you can verify the server. – 5-73 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 286: Export Data To The Network Shared Folder
Using Vscan Air CL 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. Press Patient icon on the top right corner.
Page 287 Export data Export data to the Network Shared Folder (continued) 2. Press “Exams” tab and select the desired Exam from which you wish to share images/videos. Figure 5-65. Exams Tab – 5-75 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 288 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 5-59 for more information. Select all images or videos you wish to export and Press the Share icon.
Page 289 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. – 5-77 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 290 Using Vscan Air CL Export data to the Network Shared Folder (continued) Figure 5-68. 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.
Page 291: Comprehensive Exam Info
PC. The media files are stored in a series of folders. Folder: Shared folder created by customer in PC Sub Folder: Patient ID_First Name Sub-sub Folder: Exam creation date and time(YYYYMMDDHHMMSS) Media file: Media creation date and time(YYYYMMDDHHMMSS) – 5-79 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 292 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.
Page 293: Services Environment
NOTE: The Vscan Air probe is not certified for being charged inside a road- or air ambulance. – 5-81...
Page 294: Configure The Device For The Pre-Hospital Emergency Environment
Using Vscan Air CL Configure the device for the pre-hospital emergency environment The following considerations should be made regarding the configuration of the Vscan Air for use in pre-hospital emergency environments. • The Auto-freeze time can be adjusted to keep device...
Page 295: When Time Is Critical And Charging Options Are Limited Or Unavailable
Vscan Air probe or the display devices are unavailable or limited. General considerations: • Make sure that both the Vscan Air probe and Vscan Air app selected for use has been registered and are prepared as described in section 3. •...
Page 296: Storing Devices In Between Uses
• Re-charge the display device at the intervals required to make sure that the device will be able to keep the Vscan Air app actively running for a minimum of 2 hours. Follow the display device manufacturer recommendations regarding the display device battery, battery charging and battery health.
Page 297: Preparing For A Guided Procedure With Vscan Air
Preparing for a guided procedure with Vscan Air 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.
Page 298: Assessing Display Device Wi-Fi Performance With Vscan Air Probe
Using Vscan Air CL 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.
Page 299 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.
Page 300 • Centerline marker can be turned on from the Menu -> Configuration, if desired. Please note that Vscan Air supports only free hand biopsy and needle procedures so the centerline marking should not be confused with biopsy guidelines indicating needle path on the image.
Page 301 Avoid congested Wi-Fi network environments, if possible. c. In cases where multiple Vscan Air probes and display devices with the app are available, make sure - the app is closed on all other devices except the one to...
Page 302: Digital Tools
1. MyDeviceHub MyDeviceHub is a device management tool for enterprises who have multiple Vscan Air devices and would like to manage them centrally. It is accessed by enterprise administrators via a dedicated web-based portal and provides functionality such as registration for probes, set up of user access lists, DICOM server settings, etc.
Page 303 In this case, the user may choose to use a different Vscan Air CL probe or contact the Enterprise administrator to update the access control list.
Page 304 Using Vscan Air CL 1. MyDeviceHub (continued) b. Importing server configurations The app is able to import any DICOM server settings that have been entered by the Enterprise administrator via the MyDeviceHub portal. The first time a user connects to a Fleet enabled probe, the app provides the user an option to import these settings as shown below.
Page 305 The user can also download server configurations from the backend whenever desired from the menu. Click on the button , on the Server Settings page to the import settings. Figure 5-72. Manual import of server settings – 5-93 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 306 Using Vscan Air CL 1. MyDeviceHub (continued) DICOM Server Configuration If DICOM server configurations are received from the MyDeviceHub, they will be added to Menu -> Configuration -> Server Settings Mandatory fields for each DICOM server will be displayed as received from backend, but user will need to enter secure information like Username, Password, Certificates &...
Page 307 Digital tools DICOM Server Configuration (continued) If the received configuration is incomplete, then the following indication will be shown to user. 1. Error indication Figure 5-74. Server configuration incomplete – 5-95 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 308: Myremoteshare, Powered By Zoom
NOTE: The user of the Vscan Air app is responsible for the remote participants selected, the content shared, and for obtaining appropriate patient consents if applicable. NOTE:...
Page 309 NOTE: To enable key functionality like screen share, audio and video sharing, during MyRemoteShare sessions, the user must give the following permissions to the Vscan Air app when prompted by their mobile device: 1. Access to the microphone and camera.
Page 310 Using Vscan Air CL Usage of MyRemoteShare 1. Press the Menu -> Select “Start screen share session” from MyRemoteShare tab on the Preset menu. Figure 5-75. Activate MyRemoteShare 5-98 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 311 2. Click on Start Session -> Warning message will be displayed on the screen stating that the feature is not intended for diagnostic use. The user must confirm to proceed. Figure 5-76. Warning message – 5-99 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 312 Using Vscan Air CL Usage of MyRemoteShare (continued) 3. Send the invitation link to one or more desired participants using any third-party messaging apps from the mobile device. There is also an option to copy the link if needed. Figure 5-77. Share/copy link to invite 5-100 –...
Page 313 Usage of MyRemoteShare (continued) 4. During a session, click “Invite Participants" and send to one or more desired participants using any third-party messaging apps via mobile device. Figure 5-78. Invite participants – 5-101 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 314 Using Vscan Air CL Usage of MyRemoteShare (continued) 5. Invitation is sent to the participant(s). Figure 5-79. Participant invite 6. The participant(s) must click on the URL in the invitation link to join the session. 7. MyRemoteShare session is initiated.
Page 315 Figure 5-80. Non-diagnostic banner on the participant side (not a Vscan Air screen) NOTE: The screen is a sample shot from participant side (this may vary depending on Zoom client version).
Page 316 Using Vscan Air CL Usage of MyRemoteShare (continued) 9. The host can enable/disable audio/video during the remote session. 1. Enable/disable video 2. Enable/disable audio 3. Annotation bar Figure 5-81. MyRemoteShare session 10. The host can annotate on the scan screen during the remote session (Android only).
Page 317 11. The host can toggle between front and rear camera feed during the remote session. Click on icon to open participant camera. Click on icon to rotate camera feed. Figure 5-82. Front and rear camera feed – 5-105 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 318 Using Vscan Air CL Usage of MyRemoteShare (continued) 12. The host can add/remove participant(s) during the remote session via the menu accessed by swiping in the left panel. 1. Add participant 2. Remove client (participant) 3. Mute all (other than Host) Figure 5-83.
Page 319 13. The host can end the remote session. 1. End call 2. Toggle screensharing on/off 3. Toggle Host camera on/off 4. Mute Host 5. Session duration and number of participants Figure 5-84. End the session – 5-107 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 320 Using Vscan Air CL Usage of MyRemoteShare (continued) 14. Settings and preferences for MyRemoteShare can be configured by clicking on the Settings button on the MyRemoteShare tab. The available settings include a choice to allow participants to join automatically or approve each one, as well as choices for the camera and microphone to be on or off when starting a session.
Page 321: Myimagecloud Solution
MyImageCloud. Exams and images from Vscan Air can be exported to MyImageCloud if this solution is purchased. If available for use with your Vscan Air, the option will be visible as a pre-configured export destination on the Server Settings page accessed via Menu->...
Page 322 Using Vscan Air CL Regional Instance Support To comply with regional data privacy regulations such as HIPAA and GDPR, GEHC supports regional cloud servers (e.g. USA, EU) for the MyImageCloud solution. Prior to the first export of exams to MyImageCloud, go to the Server Settings page in the Menu and select the regional instance for MyImageCloud appropriate to your location.
Page 323 The exported exam/image data can be accessed by visiting myvscan.gehealthcare.com and signing in using the same account credentials used for the Vscan Air application. An indication will be shown in the gallery against images or exams that have been exported to MyImageCloud.
Page 324 Using Vscan Air CL 5-112 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 325 Chapter 6 Vscan Air Maintenance Contents ‘System care and maintenance’ on page 6-2 ‘Cleaning and disinfection’ on page 6-6 ‘Upgrades’ on page 6-20 ‘Connectivity troubleshooting’ on page 6-24 ‘Diagnostics’ on page 6-37 ‘Probe warning messages’ on page 6-43 – Vscan Air...
Page 326: System Care And Maintenance
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...
Page 327 System care and maintenance Inspection Inspecting the Vscan Air If any defects or damages are found on the Vscan Air CL CAUTION 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): •...
Page 328 Vscan Air Maintenance Quality assurance A good Quality Assurance Evaluation program consists of periodic systematic actions that provide the user with adequate confidence that their diagnostic ultrasound system will produce consistently high-quality images and quantitative information. Therefore, it is in the best interests of every ultrasound user to routinely monitor equipment performance.
Page 329 For the operator or patient to gain access to one or two live parts, the plastic housing of the Vscan Air probe would need to be cracked open, first in one location, then in a second location.
Page 330: Cleaning And Disinfection
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.
Page 331 Contact with intact skin Cleaning followed by Intermediate-Level Disinfection Cleaning followed by Low-Level Disinfection Vscan Air is not intended for intra-operative use, it is also not intended for intra-cavitary use. It may be used during interventional procedures such as biopsy which based on proximity of the probe to the needle injection site it could get contaminated with blood or bodily fluids during use.
Page 332 EPR or trophon2 devices is one disinfection method. A trophon Wireless Ultrasound Probe Holder is required to hold the Vscan Air probe in the trophon chamber. Refer to the manufacturer’s instructions for use when using the trophon EPR or trophon2 devices.
Page 333: Probe Reprocessing
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.
Page 334 Vscan Air CL. Do not use the brush on the Vscan Air CL lenses. 6. Turn the Vscan Air CL so that the small lens is facing away from your body. 7. Gently wipe the Vscan Air CL with the cleaning wipe along the length of the Vscan Air CL.
Page 335 Step 6 if visible cleaning solution is observed. 8. Thoroughly pat dry the probe using a clean low-lint soft, dry disposable cloth or wipe. Do not use abrasive paper products. – 6-11 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 336 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.
Page 337 DO NOT soak probes in cleaner for longer than is stated by the WARNING chemical instructions for use. Extended soaking may cause probe damage and early failure of the enclosure, resulting in possible electric shock hazard. – 6-13 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 338 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.
Page 339 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. Pull cover tightly over Vscan Air CL face to remove wrinkles and air bubbles, taking care to avoid puncturing the sheath.
Page 340 Vscan Air CL probe. Cleaning of the protective case will be required if the Vscan Air CL was not properly cleaned of disinfected before it was storage in the protective case.
Page 341 This device is not indicated for neurological use. Neurological contact on patients with this disease MUST BE avoided. If the Vscan Air CL becomes contaminated, there is no adequate means to disinfect it. In this case, the contaminated device/ probe MUST BE discarded in accordance with local biological waste hazard procedures.
Page 342 Check with your local infection control authorities or product manufacturer. GE warranties and service contracts do not cover, and GE is not responsible for, damages caused by cleaning, disinfection or gel products that are not compatible with GE probes.
Page 343 Such color change does not impact the performance, safety or lifetime of the probe. If color change occurs due to disinfection with Tristel Trio Wipes System, Vscan Air probes will not be repaired or replaced under warranty or contract agreements. Table 6-3:...
Page 344: Upgrades
Software upgrades through the Apple app store or Google play may not be available in all markets. 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.
Page 345 Upgrades Vscan Air CL probe software upgrade 1. Pair the Vscan Air CL probe to the app. If the probe software needs to be updated it prompts for an upgrade ‘probe needs update’. Click on ‘start update’. – 6-21 Vscan Air...
Page 346 Vscan Air Maintenance Vscan Air CL probe software upgrade (continued) 2. The probe update is in progress. 6-22 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 347 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 whenever probe needs to be used again.
Page 348: Connectivity Troubleshooting
Connectivity troubleshooting No connection between the Vscan Air CL and the mobile device To be able to connect the Vscan Air CL to the mobile device, the mobile device’s Wi-Fi should be turned ON. If the connection is broken, try these steps: •...
Page 349 Probe may already be connected Turn ON the probe and press to a different instance of the app. probe button. If issue persists, Contact GEHC Service (see ‘Contact Information’ on page 1-12) – 6-25 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 350 Troubleshooting in Vscan Air CL Table 6-5: Troubleshooting Problem 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.
Page 351 New from iOS 14 and later, the Close the app, open Settings, Unable to join the network Vscan Air app has not been scroll down to the Vscan Air app “VAXXXXXXXXX” dialogue given Local Network access and select it to see its access observed.
Page 352 New from iOS 14 and later, the Close the app, open Settings, (pairing initiated), the Vscan Vscan Air app has not been scroll down to the Vscan Air app Air Wants to Join Wi-Fi given Local Network access and select it to see its access Network “VAXXXXXXXXX”...
Page 353 After the device restarts and you are able to open the Vscan Air app, attempt to pair again. * The need to reboot the device to solve this issue is rare. † This currently does not behave as expected and will be improved.
Page 354 It is likely the update the network is the same as that Vscan Air app. When the probe of the image display will appear of one or more networks in the returns to searching (waiting to...
Page 355 • Step 1 : Right click on the folder and select Properties. Go to Sharing tab. • Step 2: Click on Advanced Sharing. Make sure ‘Share this folder’ is selected. – 6-31 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 356 Vscan Air Maintenance Steps to troubleshoot Network shared folder connectivity challenges (continued) • Step 3 : Click on Permissions. • Step 4 : Click on Add. 6-32 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 357 Click OK. In Permissions window, Select Full Control for all the user group added. Click Apply and Click OK. – 6-33 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 358 • (c) For password refer ‘Password d. User has selected a region/country Guidelines’ on page 6-35 which is not yet cleared for Vscan Air. • (d, e) Contact GEHC Service (‘Contact e. User is deactivated in the backend. Information’ on page 1-12} 2.
Page 359 Storage commit with Vscan Air IP address/AE title/ listening port. DICOM Encoding support Permission for the shared folder to receive the transferred data from Vscan Air in case of Network share folder. – 6-35 Vscan Air User Manual...
Page 360 Contact hospital IT staff to find Exam list from MWL Wi-Fi to transfer. the root cause and can resolve the issue by addressing root Incorrect configuration of MWL cause. server on Vscan Air. 6-36 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 361: Diagnostics
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. – 6-37 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 362 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.
Page 363 Diagnostics Diagnostics Test (continued) Figure 6-5. Diagnostics Process – 6-39 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 364 Vscan Air Maintenance Diagnostics Test (continued) 5. If the Diagnostics test passes the below screen displays: Figure 6-6. Diagnostics Passed 6-40 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 365 GEHC service access 1 year before being deleted from the server. 7. GEHC service runs checklist. 8. GEHC service places the order for the replacement Vscan Air CL and provides shipment details. – 6-41 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 366: Transducer Element Test
Vscan Air Maintenance 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 ->...
Page 367: Probe Warning Messages
Probe voltage is at critical level and will shut down. If the WARNING problem persists, contact GEHC. Connectivity error Unable to connect. Check your internet connection and try WARNING again. – 6-43 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 368 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. If the Vscan Air app is inactive and/or not connected to internet for more than 70 days you will see the following message when you try to use the app.
Page 369 Probe warning messages 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.
Page 370 Vscan Air Maintenance 6-46 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 371 Privacy and Security Contents ‘Introduction’ on page 7-2 ‘Network Connectivity’ on page 7-5 ‘Business Continuity’ on page 7-7 ‘System Protection’ on page 7-8 ‘Personal Information Collected by the Product’ on page 7-10 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 372: Introduction
Introduction Overview This chapter describes Privacy and Security considerations for the use of the Vscan Air. It describes the expected intended use, the Privacy and Security capabilities included, and how they are configured and used appropriately. This chapter assumes that the reader understands the concepts of Privacy and Security.
Page 373: Privacy And Security Environment Requirements
1. The device should be connected to a secured network, not open to unintended users. 2. The Vscan Air CL should be physically secured in a way that it is not accessible for unintended users. 3. The display of the Vscan Air should be placed in a way limiting the visibility to the user only.
Page 374: Network Requirements
2. Both DHCP and static IP allocation are supported Network Protocols Wireless network protocols The following wireless protocols are supported: 1. IEEE 802.11a 2. IEEE 802.11b 3. IEEE 802.11g 4. IEEE 802.11n Internet Protocol Version: 1. IPv4 2. IPv6 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 375: Network Connectivity
This section of the manual focuses on Privacy and Security operations and contains information to guide in the preparation of a secure environment for the Vscan Air ultrasound system. Security operations is best implemented as part of an overall “defense in depth” information assurance strategy; this is used throughout an Information Technology system that addresses personnel, physical security and technology.
Page 376: Wireless Security
The Vscan Air supports sharing images, videos or exams via the share function on the Vscan Air app. The security of data shared by the Vscan Air must be taken care of on the system where data is stored. –...
Page 377: Business Continuity
Export data The Vscan Air is regarded as an 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.
Page 378: System Protection
Host OS and other host software negative compatibility Ensure that Vscan Air CL probe software and the Vscan Air App software versions are latest and compatible with one another. Incompatible softwares could cause issues in the basic functionality of the Vscan Air application.
Page 379: Recommendation
System Protection Recommendation: Following types of apps are recommended to be used along with Vscan Air on Android and iOS: • Trusted apps downloaded and installed from the Google Play Store or App Store. • No untrusted firewalls, VPN, network sniffing apps, sharing apps etc.
Page 380: Personal Information Collected By The Product
2. Stored images will hold date and time 3. Equipment owner information 4. Device data Patient information collected by the user cannot be entered or stored by Vscan Air. Details on what data is collected, used and disclosed can be obtained by contacting GE Healthcare. 7-10 –...
Page 381: Potential Hazardous Situations Resulting From Failures Of The It Network
Warning In addition to the hazardous situations identified above, connection of the Vscan Air to a network that includes other equipment could result in other unidentified risks to patients, operators or third parties. The responsible organization should identify, analyze, evaluate and control these risks on an ongoing basis.
Page 382 Privacy and Security 7-12 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 383 Chapter 8 Appendix Contents: ‘Specifications’ on page 8-2 ‘Acoustic Output’ on page 8-3 ‘Appendices’ on page 8-15 ‘Measurement accuracy’ on page 8-16 ‘Indications Reference Guide’ on page 8-18 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 384: Specifications
Broad-bandwidth linear array: from 3 - 12 MHz with center frequency of 7.7 MHz • Number of elements: 192 • Footprint: 40 mm x 7 mm (lens) • Depth: up to 8 cm – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 385: Acoustic Output
TI category presented to the operator. It is therefore important that the operator chooses the right application. Vscan Air will for each scan setup calculate and limit TI for the chosen index category to 3.0. –...
Page 386 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 p (z) is not limited by the breakpoint depth. The MI according to IEC62359 Ed2 will not exceed 1.9. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 387: Controls Affecting Acoustic Output
Pulse repetition frequency ----> Pulse length ----> Mode combination ----> SPTA ----> Thermal/mechanical Application ----> TIS/TIB/TIC Indices to Output Display Acoustic ouput control ----> Probe sensitivity ----> FDA Limits @ 95% confidence tolerance – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 388: Probe Surface Temperature Safety Mechanisms
‘Maximum Vscan Air CL temperature’ on page 2-24 section in this user manual. The Vscan Air probe is equipped with internal temperature sensors and mechanisms to monitor and limit the probe temperature so that the lens surface temperature is kept <43°C.
Page 389: Acoustic Parameters As Measured In Water
Acoustic working frequency Pulse repetition rate Scan repetition rate Number of pulses per scan line Attenuated pulse average intensity α Attenuated speatial-peak temporal-average intensity α spta, Spatial-peak temporal-average intensity spta Peak-rare-factional acoustic pressure – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 390 Appendix Operating Conditions All table entries are with the operating conditions specified at the end of the table. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 391: Acoustic Output Reporting Tables For Track 3/En/Iec 60601-2-37
Transducer Model: Curved array transducer Operating Mode: black and white (including harmonic) Figure 8-2. Curved array transducer - black/white (including harmonic) NOTE: This transducer does not have a preset optimized for Transcranial/Neonatal cephalic use. – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 392 Operating Mode: black and white (including harmonic) and color Figure 8-3. Curved array transducer - black/white (including harmonic) and color NOTE: This transducer does not have a preset optimized for Transcranial/Neonatal cephalic use. 8-10 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 393 Transducer Model: Linear array transducer Operating Mode: black and white (including harmonic) Figure 8-4. Linear array transducer - black/white (including harmonic) NOTE: This transducer does not have a preset optimized for Obstetric/ Fetal use. – 8-11 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 394 Operating Mode: black and white (including harmonic) and color Figure 8-5. Linear array transducer - black/white (including harmonic) and color NOTE: This transducer does not have a preset optimized for Obstetric/ Fetal use. 8-12 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 395 Transducer Model: Linear array transducer Operating Mode: black and white, Ophthalmic Figure 8-6. Linear array transducer - black/white, Ophthalmic NOTE: The Linear array Ophthalmic preset is not optimized for Obstetric/Fetal or Transcranial/Neonatal cephalic use. – 8-13 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 396 Operating Mode: black and white and color, Ophthalmic Figure 8-7. Linear array transducer - black/white and color, Ophthalmic NOTE: The Linear array Ophthalmic preset is not optimized for Obstetric/Fetal or Transcranial/Neonatal cephalic use. 8-14 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 397: Appendices
Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. – 8-15 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 398: Measurement Accuracy
2mm-200mm ±1mm or ±3% whichever is greater Lateral cm or mm 4mm-100mm ±2mm or ±5% whichever is greater Circumference (ellipse) cm or mm 10mm-300mm ±5% or ±2mm whichever is greater 8-16 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 399 The average value 1540 meters / second is used for all calculations. Depending on the tissue structures, this generalization may give errors from 2% (typical) to 5% (much fatty tissue layers present). – 8-17 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 400: Indications Reference Guide
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. Vscan Air is indicated for ultrasound imaging,...
Page 401 • Tibia/fibula • Ligament and joint integrity • Radius/ulna • Tendon injuries (tendonitis, rupture/ • Muscles tear) • Ligaments • Muscle tears • Tendons • Peripheral nerve blocks • Nerves – 8-19 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 402: Linear Array (Shallow Scanning) Transducer
• FASH • FASE Linear Array (Shallow scanning) Transducer The linear array transducer on Vscan Air CL supports Black/ white (B-mode), Color (Color doppler) and Harmonic imaging modes. Vscan Air is indicated for ultrasound imaging, measurement, and analysis of the human body in clinical...
Page 403 • Cervical Lymph nodes • Neck masses (Adult / Pediatric) • Trachea • Airway assessment • Epiglottis, cricoid cartilage, • Vocal cord dysfunction cricothyroid membrane • Esophagus • Vocal folds – 8-21 Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 404 • Superficial and mid-superficial cranial • Superior sagittal sinus thrombosis structures • Cerebral edema • Extra-axial fluid collections Protocols • Lungs • eFAST • BLUE Disclaimer: Ophthalmic is not available in Japan and China. 8-22 – Vscan Air User Manual Direction GP092020-1EN Rev 18...
Page 405: Index
Diagnostics, 4-51 Display Features, 5-2 Upgrade application software, 6-20 information, requesting, 1-12 Initial use, 3-24 Voltage requirements, 3-18 Inspection, 6-3 Vscan Air Settings, 4-1 Maintenance, 6-1 Measurements, 5-50 Network Connectivity, 7-5 Package contents, 3-2 Patient examination, 5-10 – Vscan Air...
Page 406 – Index Vscan Air User Manual Direction GP092020-1EN Rev 18...

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