GE Vscan Air Manual Download Page 18

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i-16

Vscan Air

–

User Manual

Direction GP092020-1EN

Rev 17

Chapter 7 — Privacy and Security

Introduction

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-2
How to contact GEHC - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-2
Privacy and Security Environment Requirements- - - - - - - - - - - - - - - - -  7-3
Network Requirements  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-4
Network Protocols- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-4

Network Connectivity

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-5
Network Security  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-5
Wireless Security  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-6

Business Continuity

Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-7
Export data  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-7
Sharing images  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-7

System Protection

Vscan Air – system protection  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-8
Host OS and other host software negative compatibility - - - - - - - - - - - -  7-8
Recommendation:- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  7-9

Personal Information Collected by the Product

Information collection and use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-10
Potential Hazardous Situations Resulting From Failures of the IT Network - -

7-11

Chapter 8 — Appendix

Specifications

Dimension and weight (maximum) - - - - - - - - - - - - - - - - - - - - - - - - - - -  8-2
Curved array transducer for deep scanning - - - - - - - - - - - - - - - - - - - - -  8-2
Linear array transducer for shallow scanning- - - - - - - - - - - - - - - - - - - -  8-2

Acoustic Output

The real-time display of acoustic output indices - - - - - - - - - - - - - - - - - -  8-3
Controls Affecting Acoustic Output - - - - - - - - - - - - - - - - - - - - - - - - - - -  8-5
Probe surface temperature safety mechanisms - - - - - - - - - - - - - - - - - -  8-6
Acoustic Parameters as Measured in Water  - - - - - - - - - - - - - - - - - - - -  8-7
Acoustic Output Reporting Tables for Track 3/EN/IEC 60601-2-37  - - - -  8-9

Appendices

Statements on the safety of ultrasound - - - - - - - - - - - - - - - - - - - - - - - 8-15

Measurement accuracy

Measurement accuracy - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-16

Indications Reference Guide

Disclaimer  - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -  8-18
Curved Array (Deep scanning) Transducer - - - - - - - - - - - - - - - - - - - -  8-18
Linear Array (Shallow scanning) Transducer - - - - - - - - - - - - - - - - - - -  8-20

Index

Summary of Contents for Vscan Air

Page 2: ...1 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 Manufacturer GE VINGMED ULTRASOUND AS Strandpromenaden 45 3191 Ho...

Page 3: ...rmation Australia and New Zealand Page i 6 Updated section Country Specific Approval Morocco label Rev 16 25 Nov 2021 Page i 6 Updated section Country Specific Approval Indonesia importer and license...

Page 4: ...d section Country Specific Approval Korea KC symbol and license number Brazil importer info Chapter 1 Added section Clinical application not cleared for use in China Chapter 2 Updated Figure 2 5 Batte...

Page 5: ...Vscan Air User Manual i 3 Direction GP092020 1EN Rev 18 This page intentionally left blank...

Page 6: ...ng is shown in the Safety chapter of this manual Year of first CE mark 2020 2014 53 EU Radio Equipment Directive RED 2011 65 EU including 2015 863 EU Annex II Directive on the restriction of the use o...

Page 7: ...ion to be supplied Part 1 General requirements EN1041 Information supplied by the manufacturer with medical devices IEC 62209 2 Human exposure to radio frequency fields from hand held and body mounted...

Page 8: ...ir CL probe has an internal battery which allows the operation during AC power absence The AC adapter is Class II The Vscan Air CL probe is IP67 meaning that it can be submerged in 1m of water for 30...

Page 9: ...t providing a specified degree of protection against electric shock with regard to allowable leakage current Original documentation The original document was written in English Table i 2 Leakage curre...

Page 10: ...d GE Medical Systems Thailand Ltd 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 Jakart...

Page 11: ...11 RESPONS VEL T CNICO Karolina Morangoni Torres Registro CREA SP n 5069785521 FABRICANTE LEGAL GE VINGMED ULTRASOUND AS INFORMA ES DO IMPORTADOR E DISTRIBUIDOR NOME GE HEALTHCARE DO BRASIL COM RCIO E...

Page 12: ...Vscan Air app Instru o de uso partes e acess rios REGISTRO ANVISA N 80071260434 RESPONS VEL T CNICO Karolina Morangoni Torres Registro CREA SP n 5069785521 FABRICANTE LEGAL GE VINGMED ULTRASOUND AS IN...

Page 13: ...1EN Rev 18 Telecom Certification Information continued USA 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 Vsc...

Page 14: ...i 12 Vscan Air User Manual Direction GP092020 1EN Rev 18...

Page 15: ...g conventions 1 4 General description 1 4 Wireless Description 1 5 Principles of operation 1 5 Safety 1 6 Intended use 1 6 Indications for use 1 6 Contraindications for use 1 8 Intended users 1 8 Pres...

Page 16: ...an Air CL for Use Package contents Vscan Air CL shipment box contents 3 2 Environmental requirements Environmental requirements for Vscan Air CL 3 8 Transient operating conditions 3 8 System descripti...

Page 17: ...vice for the pre hospital emergency environment 5 82 When time is critical and charging options are limited or unavailable 5 83 Storing devices in between uses 5 84 Preparing for a guided procedure wi...

Page 18: ...lection and use 7 10 Potential Hazardous Situations Resulting From Failures of the IT Network 7 11 Chapter 8 Appendix Specifications Dimension and weight maximum 8 2 Curved array transducer for deep s...

Page 19: ...Vscan Air User Manual 1 1 Direction GP092020 1EN Rev 18 Chapter 1 Introduction Contents Overview on page 1 2 Warnings on page 1 10 Contact Information on page 1 12...

Page 20: ...blication of the user manual Documentation Vscan Air documentation consists of various manuals The User Manual TRANSLATED the quick start guide and onboard app walkthrough provides information needed...

Page 21: ...may differ with different software revisions NOTE The labels displayed in this manual are only for illustration purposes The label content may be different for different regions Please refer to the s...

Page 22: ...nd imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid Vscan Air consists of a dual headed probe which in...

Page 23: ...ctrical signals into a series of digital image signals which are stored in memory Once in memory the image can be displayed in real time on the display device A probe is an accurate solid state device...

Page 24: ...d trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country state or other local municipality in which he or she practices The users may or may no...

Page 25: ...clinical applications and exam types include vascular peripheral vascular musculoskeletal conventional and superficial small organs thoracic lung ophthalmic pediatrics neonatal cephalic interventiona...

Page 26: ...king under supervision or authority of a physician Each user is expected to have a basic level of general ultrasound training that includes limited image acquisition techniques and interpretation i e...

Page 27: ...edical providers like nurses supervised nurses nurse practitioners physician assistants sonographers midwives supervised midwives residents chiropractors and physical therapists Medical students Guide...

Page 28: ...top using the unit if it emits smoke or noxious fumes Failure to do so may result in electrical shock or fire Stop using the unit if there is any damage to covers or transducer front faces Failure to...

Page 29: ...Keep good hand contact with Vscan Air CL during scanning to avoid heating up of the unit and termination of scan due to built in temperature limits Disconnect the AC adapter and the wireless charger w...

Page 30: ...t resource listed on the following pages Clinical Questions For information in the United States Canada Mexico and parts of the Caribbean call the Customer Answer Center TEL 1 800 682 5327 or 1 262 52...

Page 31: ...lobal ultrasound support center phone numbers For countries not listed in the tables below please contact the local distributor Table 1 5 Americas ARGENTINA TEL 0800 222 4342 BRAZIL Capitais e Regi es...

Page 32: ...contacting GEHC CARES for your Vscan Air you will need to provide the serial number printed on your Vscan Air probe TEL 1 800 437 1171 FAX 1 414 721 3865 Table 1 6 Asia ASIA PACIFIC JAPAN TEL 81 42 58...

Page 33: ...Bratislava servis gehc ge com TEL 02 44460030 FAX 00421244460032 ROMANIA Bucharest callcenterro ge com ana maria gindea ge com TEL 0040311305293 VIP 0040 311 305 099 Affidea 0040 311 305 294 FAX 40 37...

Page 34: ...05480 IRELAND NORTHERN IRELAND REPUBLIC OF IRELAND TEL 0044 800 072 0248 TEL 1800 992 557 FAX 353 1 686 5327 ITALY North Centre South front office ge com service ge com TEL 39 02 2600 1111 FAX 39 02...

Page 35: ...33 02 11 16 POLAND SerwisPolska ge com TEL 48 22 330 83 30 or 00800 803 803 0048 22 330 83 99 PORTUGAL Madrid GEHealthcareServiceCenterIberia ge com TEL 351 21 425 1300 FAX 351 21 425 1343 TEL 0035 80...

Page 36: ...02 NIGERIA 0023414642220 GHANA 00233501555066 KENYA 0800721761 UNITED ARAB EMIRATES UAE TEL 971 4 429 6101 or 4 429 6161 TEL 8003646 UNITED KINGDOM Pollards Woods UK ultrasoundandbmdsdc ge com TEL 44...

Page 37: ...tion GP092020 1EN Rev 18 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 l...

Page 38: ...e precautions NOTE Indicates precautions or recommendations that should be used in the operation of the ultrasound system specifically Maintaining an optimum system environment Using this Manual Notes...

Page 39: ...the person has read and fully understands the operating instructions contained in this manual It is advisable to maintain a list of authorized operators Should the system fail to operate correctly or...

Page 40: ...could result in injury or damage NOTE It is user responsibility to safeguard data exported from the Vscan Air app and used outside the Vscan Air app NOTE As a safety precaution scanning is not possib...

Page 41: ...re making any decision based on quantitative values If in doubt the nearest GEHC ultrasound service office should be consulted Equipment malfunction or incorrect settings can result in measurement err...

Page 42: ...ds If flammable substances are detected in the environment do not plug in or turn on the device If flammable substances are detected after the device has been turned on do not attempt to turn off the...

Page 43: ...can Air CL probe is an internally powered device type BF The AC adapter is Class II External connection Figure 2 1 Patient environment CAUTION Charging of Vscan Air CL via the AC adapter and the wirel...

Page 44: ...in EN IEC 60601 1 2 It complies with emission limits in RTCA DO 160G Section 21 Category M and ETSI EN 301489 1 and ETSI EN 301489 17 NOTE The ultrasound unit is suitable for use in all establishments...

Page 45: ...esentative for further suggestions Unauthorized changes or modifications could void the user s authority to operate the equipment To comply with the regulations on electromagnetic interference all int...

Page 46: ...rasound unit should assure that the device is used in such an environment NOTE It is advised to keep a 30 cm separation distance in between the Vscan Air CL probe and the display device running the Vs...

Page 47: ...ion If this equipment does cause harmful interference to radio or television Reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interfer...

Page 48: ...n est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage...

Page 49: ...t Compliance Electromagnetic environment guidance RF emission EN55011 Group 1 The Vscan Air CL uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely...

Page 50: ...ic environment guidance Electrostatic discharge ESD EN IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic m...

Page 51: ...s interruptions it is recommended that the Vscan Air CL is powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field EN IEC 61000 4 8 30 A m 50 and 60 Hz 30 A m...

Page 52: ...from RF wireless communications equipment IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 385 MHz 18 Hz Pulse Modulation 27 V m 450 MHz FM 5 kHz deviation...

Page 53: ...index categories TIS Soft tissue thermal index The main TI category Used for applications that do not image bone TIB Bone thermal index bone located in a focal region Used for fetal application TIC Cr...

Page 54: ...e scanning refer Black white imaging mode B mode on page 3 15 Accuracy of the displayed acoustic output and acoustic measurement uncertainties The accuracy of the displayed acoustic output and the aco...

Page 55: ...ical ultrasound imaging should only be used for medical diagnosis Ultrasound equipment should only be used by people who are fully trained in its safe and proper operation This requires an appreciatio...

Page 56: ...ial statements of the American Institute of Table 2 5 Recommended maximum scanning times Obstetric scanning General Abdominal Peripheral Vascular Musculoskeletal Cardiac and other not listed applicati...

Page 57: ...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 Table 2 6 Recommended maximum scanning times Neonat...

Page 58: ...harmful in some conditions 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 A...

Page 59: ...diagnostic image is achieved prolonging the exposure cannot be justified It is recommended that all users receive proper training in applications before performing them in a clinical setting Environme...

Page 60: ...probes Maximum Vscan Air CL temperature rise is measured and added to 33 C Maximum Vscan Air CL temperature Simulated use is 43 C With Vscan Air CL transmitting in air temperature rise is measured and...

Page 61: ...al 2 25 Direction GP092020 1EN Rev 18 Device labels and symbols Vscan Air labels Figure 2 2 Vscan Air CL probe rating label versions 1 Laser printed label for Vscan Air CL probe US Version 2 Laser pri...

Page 62: ...ty 2 26 Vscan Air User Manual Direction GP092020 1EN Rev 18 Vscan Air labels continued Figure 2 3 Vscan Air app rating label versions 1 Vscan Air for Android rating label 2 Vscan Air for iOS rating la...

Page 63: ...ir 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 differe...

Page 64: ...commission your equipment Vscan Air CL probe Vscan Air probe battery EN 50419 Follow instructions for use Read and understand all instructions in the User s Manual before attempting to use the ultraso...

Page 65: ...scan Air CL probe N A by GEHC IP67 Vscan Air can be completely submerged upto 1m in water Vscan Air CL probe IEC 60529 LOT Batch or lot code Vscan Air app ISO 7000 2492 CAUTION For use with Vscan Air...

Page 66: ...om radio and wireless marking Label Purpose Location Standard FCC ID IC ID Federal Communications Commission Identification number IC ID The Canadian certification ID number relating to radio apparatu...

Page 67: ...UP which indicates the period during which the hazardous substances contained in electrical and electronic products will not result in any severe environmental pollution any bodily injury or damage to...

Page 68: ...GB T 26572 X GB T 26572 O Indicates that hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB T 26572 X Indicates that hazardous substa...

Page 69: ...0 1EN Rev 18 Chapter 3 Preparing Vscan Air CL for Use 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 Ba...

Page 70: ...items listed below are included in the package 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 1 Vscan Air Quic...

Page 71: ...wireless charging pad package contents Figure 3 2 Anker PowerWave charging pad package contents 1 Package contents with front and back cover 2 Instruction booklet 3 Package contents with PowerWave Pad...

Page 72: ...e is the FIRST STEP that needs to be performed before trying to turn the Vscan Air on The Vscan Air probe will not start unless an initial charging cycle has been initiated 2 To turn ON the Vscan Air...

Page 73: ...l 3 5 Direction GP092020 1EN Rev 18 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 p...

Page 74: ...charged with the Anker PowerWave charging pad The LEDs will light in an orange red toned yellow color Whenever charge is less than 8 and probe needs a higher charge level to allow starting Yellow lig...

Page 75: ...ging has started NOTE Both LEDs will be blinking in case of any kind of charging issue This is most likely caused by the probe and battery being too warm start charging Please let the probe cool off a...

Page 76: ...C function for a minimum of 20 minutes NOTE Avoid exposing the unit to saline moisture In case of exposure to saline moisture clean the unit as described in Cleaning and disinfection on page 6 6 Image...

Page 77: ...vices 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 servic...

Page 78: ...irelessly transmitted to a phone or a tablet and displayed via the installed Vscan Air app The Vscan Air App provides the user interface and the needed software functionality for using a generic mobil...

Page 79: ...cation NOT CONNECTED TO PROBE White outline of the probe and battery charge indication CONNECTED TO PROBE Wireless connection quality indicator A wireless probe has a limited inherent risk of a disrup...

Page 80: ...ks and displays changes in the operating temperature of the probe during scanning Factors affecting probe temperature are Transducer Curved array transducer gets warm more quickly than linear array du...

Page 81: ...vels 0 4 Level 0 is the initial state when starting with a cool probe as indicated in the figure 3 4 below The probe temperature changes during a scan based on the factors described above The temperat...

Page 82: ...for Use 3 14 Vscan Air User Manual Direction GP092020 1EN Rev 18 Probe temperature indicator and thermal management continued Figure 3 5 Thermal indicator toast message Figure 3 6 Thermal warning mess...

Page 83: ...7 Exam number 8 Focus marker 9 Depth 10 Store 11 Freeze 12 Color flow 13 Thermal Index TI 14 Mechanical Index MI 15 Resolution Penetration toggle button Linear array shallow scanning transducer 1 Imag...

Page 84: ...ion GP092020 1EN Rev 18 Accessories Optional accessories NOTE Details about types of AC power plugs are included in Power plugs on page 3 18 Table 3 2 International AC Adapter Accessory Figure AC Adap...

Page 85: ...in the section How to charge the Vscan Air CL on page 3 4 The battery specification is shown in the below table Battery specification Table 3 3 Battery specification Items Unit Value Description Basic...

Page 86: ...50 60 Hz 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 1 Type C Europe Turkey Korea Indonesia Philippines Thaila...

Page 87: ...Vscan Air CL is connected to the Vscan Air App The following icons are displayed Table 3 4 Battery level indicator Icon Description Battery charged 90 100 Battery charged 80 90 Battery charged 65 80...

Page 88: ...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...

Page 89: ...s via the LED lights Figure 3 10 LED states when Vscan Air CL is OFF No light indicates a Vscan Air CL charge level in the range 8 and probe will need to charge above 8 to be powered on A steady yello...

Page 90: ...d 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 indica...

Page 91: ...times each day if needed To minimize battery performance degradation avoid prolonged storage of the Vscan Air CL probe outside the specified temperature range NOTE To maximize battery life it is recom...

Page 92: ...atibility with Google Play store iPad and iPhone devices with iOS 13 14 or 15 Screen requirements Size from 5 to 20 inches 960 x 640 or 640 x 960 pixel or more Internal memory requirement 8GB or more...

Page 93: ...d for the following display devices Apple iPhones Device Operating system iPhone 13 Pro Max iOS 15 4 iPhone 13 Pro iOS 15 0 iPhone 13 iOS 15 0 iPhone 13 mini iOS 15 0 iPhone 12 Pro Max iOS 14 2 iOS 15...

Page 94: ...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 iPadOS 13 7 iPa...

Page 95: ...amsung Galaxy S22 Android 12 Samsung Galaxy S21 Ultra Intl Android 11 Samsung Galaxy S21 Intl Android 11 Samsung Galaxy S21 Intl Android 11 Samsung Galaxy S20 FE 5G Intl Android 11 Samsung Galaxy S20...

Page 96: ...device It is not recommended to upgrade your device OS to a major release not listed for your device http vscanair support gehealthcare com support solutions articles 47001169561 vscan air compatible...

Page 97: ...ete grey scale The lowest levels should just disappear into the black background and the highest white should be bright but not saturated Following can be done to adjust the display brightness of the...

Page 98: ...ual Direction GP092020 1EN Rev 18 Display device image quality verification continued Recommended example images Abdominal preset on Curved and MSK preset on Linear transducer Figure 3 13 Screen with...

Page 99: ...tive brightness and display filters Power ON OFF To power on the Vscan Air the first time the first step is to start a charging cycle Place the Vscan Air CL probe on the wireless charging pad as shown...

Page 100: ...can Air app installation 1 Power ON the display device 2 Download the Vscan Air app via Google Play Store or Apple App Store depending on your display device OS 3 Install the Vscan Air app on your dev...

Page 101: ...User Manual 3 33 Direction GP092020 1EN Rev 18 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...

Page 102: ...lect Create new account on SIGN IN screen Figure 3 17 Register the Vscan Air app NOTE For security reasons if the sign in screen is kept open for more than 30 minutes user is expected to close and ope...

Page 103: ...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 foun...

Page 104: ...Direction GP092020 1EN Rev 18 Create a Vscan Air user account continued 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...

Page 105: ...Initial use Vscan Air User Manual 3 37 Direction GP092020 1EN Rev 18 Create a Vscan Air user account continued 5 Wait for initialization of Vscan Air CL Figure 3 20 Initialization of Vscan Air CL...

Page 106: ...ir CL for Use 3 38 Vscan Air User Manual Direction GP092020 1EN Rev 18 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 Co...

Page 107: ...ser 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...

Page 108: ...18 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 receiv...

Page 109: ...20 1EN Rev 18 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...

Page 110: ...se 3 42 Vscan Air User Manual Direction GP092020 1EN Rev 18 Create a Vscan Air user account continued 13 The following activation email will be sent to the registered email Figure 3 25 Email message N...

Page 111: ...r account 15 The account is activated Sign into the new account Figure 3 26 Sign in to the account NOTE Some mobile devices have convenience settings for keyboards such as slide to type or swipe keybo...

Page 112: ...er 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 r...

Page 113: ...r Manual 3 45 Direction GP092020 1EN Rev 18 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 Conf...

Page 114: ...rection GP092020 1EN Rev 18 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...

Page 115: ...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...

Page 116: ...rection GP092020 1EN Rev 18 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...

Page 117: ...on 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 We...

Page 118: ...scan Air User Manual Direction GP092020 1EN Rev 18 New Vscan Air app registration using an existing account continued 2 Enter the email address and password for your existing Vscan Air account Figure...

Page 119: ...Air User Manual 3 51 Direction GP092020 1EN Rev 18 New Vscan Air app registration using an existing account continued 3 Confirm that registration details are correct or edit if needed Figure 3 34 Con...

Page 120: ...Use 3 52 Vscan Air User Manual Direction GP092020 1EN Rev 18 New Vscan Air app registration using an existing account continued 4 On confirmation the registration completion screen is displayed Figure...

Page 121: ...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 registrat...

Page 122: ...ir CL for Use 3 54 Vscan Air User Manual Direction GP092020 1EN Rev 18 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 V...

Page 123: ...Air User Manual 3 55 Direction GP092020 1EN Rev 18 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 V...

Page 124: ...L for Use 3 56 Vscan Air User Manual Direction GP092020 1EN Rev 18 New Vscan Air CL probe registration using existing account continued 4 Wait for initialization of Vscan Air CL Figure 3 39 Initializa...

Page 125: ...scan 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 connec...

Page 126: ...r Manual Direction GP092020 1EN Rev 18 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 Ai...

Page 127: ...Air User Manual 3 59 Direction GP092020 1EN Rev 18 New Vscan Air CL probe registration using existing account continued 7 Confirm that registration details are correct or edit if needed Figure 3 42 Co...

Page 128: ...Preparing Vscan Air CL for Use 3 60 Vscan Air User Manual Direction GP092020 1EN Rev 18 New Vscan Air CL probe registration using existing account continued Figure 3 43 Registration complete...

Page 129: ...al 3 61 Direction GP092020 1EN Rev 18 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 Figur...

Page 130: ...al Direction GP092020 1EN Rev 18 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...

Page 131: ...Manual 3 63 Direction GP092020 1EN Rev 18 Adding users 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 butt...

Page 132: ...P092020 1EN Rev 18 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...

Page 133: ...use Vscan Air User Manual 3 65 Direction GP092020 1EN Rev 18 Adding users continued 3 If the entered email is not yet registered user will be taken to user registration screen Figure 3 48 User regist...

Page 134: ...tered email address to validate the Vscan Air user account NOTE 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...

Page 135: ...to scanning is required NOTE If a user selects to not sign in access will be limited to scan related functionality only Guest users will be able to save images during the current exam and review them...

Page 136: ...nual Direction GP092020 1EN Rev 18 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 p...

Page 137: ...Manual 3 69 Direction GP092020 1EN Rev 18 Scan without signing in Guest continued 3 To exist Guest mode click on the exit button on the top right corner of the left panel menu Figure 3 52 Exit Guest...

Page 138: ...ntered credentials are incorrect the application will show an error message Figure 3 53 Incorrect credentials 2 The user initials which is the first letter of the first and last name of the signed in...

Page 139: ...8 User sign in sign out continued 4 To sign out click on the Sign out Exit icon on the top right corner of the left side panel Figure 3 54 Signed in user displayed in the top of the left panel 1 User...

Page 140: ...o the sign in screen on successful sign out Figure 3 55 Sign in screen NOTE An automatic sign out duration configuration setting is available The app will automatically sign out a user per this settin...

Page 141: ...scan 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 l...

Page 142: ...User will be prompted to login once again on the portal with his her credentials This is to ensure that the actual logged in user from application is initiating the delete operation NOTE In the proces...

Page 143: ...data including the images and videos will be deleted NOTE On an Android device it is possible to go into settings and clear data for an app If selecting to do so all app related data Including exam d...

Page 144: ...ss 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 pro...

Page 145: ...w 6 digit PIN in the field on the Set up data access PIN screen and Press Next button Figure 3 59 Enter data access PIN NOTE Please make sure to use a strong PIN and avoid using PIN codes that are eas...

Page 146: ...een and Press Save button After successful set up of data access PIN application takes you to the Security screen Figure 3 60 Confirm data access PIN TouchID for quick data access Biometric authentica...

Page 147: ...an Air App functions in a non medical Preview mode until activated The Vscan Air CL probe has no ability to connect to Vscan Air App while in Preview mode We can explore all the main functionality of...

Page 148: ...t to the background on the display device NOTE Scanning stops within 10 seconds if the Wi Fi link to the Vscan Air CL probe is lost NOTE Scanning never starts when there is a critical error e g batter...

Page 149: ...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 Regis...

Page 150: ...After selecting Unregister button the below message appear 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...

Page 151: ...er 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 Regi...

Page 152: ...3 66 Unregister app warning 4 Press Erase button on Confirmation screen On selecting the Erase button the app is unregistered from the display device and all the patient data is erased Figure 3 67 Era...

Page 153: ...ual 4 1 Direction GP092020 1EN Rev 18 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 A...

Page 154: ...or iOS and Android 4 2 Vscan Air User Manual Direction GP092020 1EN Rev 18 Configuration The following functions are available under the main menu 1 Configuration 2 User account 3 Support 4 Diagnostic...

Page 155: ...t Menu at the top to access the settings panel The Configuration option displays Centerline marker Focus marker TGC control Cardiac Flip L R Auto freeze time Video duration Probe button action Measure...

Page 156: ...mode and on recalled images and videos Figure 4 3 Centerline marker NOTE Configure the display device with an adequate screen save timeout Configure the app with an adequate auto freeze timeout in cas...

Page 157: ...GC controls are available in portrait and landscape layouts NOTE The active gain control is disabled as long as the TGC controls are active 4 Cardiac Flip L R see Configuration on page 4 3 Setting the...

Page 158: ...Air Configuration for iOS and Android 4 6 Vscan Air User Manual Direction GP092020 1EN Rev 18 Configuration continued Flip Left Right option will be available for Cardiac preset Figure 4 5 CLA Cardiac...

Page 159: ...n the desired value to set the auto freeze time This sets the time after which the system enters Freeze mode when not in use Figure 4 6 Auto freeze time NOTE Configure the display device with an adequ...

Page 160: ...on is related to the number of seconds of scan data that is available in the buffer after freezing the image Tap on the desired value to set the buffer size Figure 4 7 Video duration 7 Probe Button Ac...

Page 161: ...8 Measurement Unit see Configuration on page 4 3 Tap to choose either cm or mm Figure 4 9 Measurement unit 9 Preview Mode see Configuration on page 4 3 Tap the ON OFF toggle switch to turn ON or OFF...

Page 162: ...inary image data When turned ON a pop up message displays Binary image data storage is now enabled and unprocessed data will be stored together with video clips This uses some additional storage space...

Page 163: ...1EN Rev 18 Configuration continued 11 Language see Configuration on page 4 3 Choose the desired language Figure 4 12 Language CAUTION Vscan Air App defaults to English if the current language setting...

Page 164: ...iguration 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 r...

Page 165: ...h 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...

Page 166: ...er an option to control the duration of the signed in session The default value is 24 hours Other available options are shown below To change the auto sign out setting navigate to Menu Configuration A...

Page 167: ...User Manual 4 15 Direction GP092020 1EN Rev 18 Configure Modality Worklist Server Follow the procedure below to configure a new Modality Worklist Server 1 Press Menu Configuration Server Settings Figu...

Page 168: ...ir Configuration for iOS and Android 4 16 Vscan Air User Manual Direction GP092020 1EN Rev 18 Configure Modality Worklist Server continued 2 Press Add Server in Server Settings screen Figure 4 17 Add...

Page 169: ...dality Worklist Server from the drop down list of Server Type and enter the configuration information in the respective fields to add Modality Worklist Server If Modality Worklist Server is of Secure...

Page 170: ...r Verify server succeed pop up message displays if the communication with the Worklist Server is established successfully Press OK and then Press Add to add the Modality Worklist Server If communicati...

Page 171: ...er Settings If this is the first Modality Worklist MWL server that is added it will be set as the favourite server by default If there are more than one MWL Radiology Information System RIS server the...

Page 172: ...nd Android 4 20 Vscan Air User Manual Direction GP092020 1EN Rev 18 Configure DICOM Image Server Follow the procedure below to configure a new DICOM Image Server 1 Press Menu Configuration Server Sett...

Page 173: ...Configuration Vscan Air User Manual 4 21 Direction GP092020 1EN Rev 18 Configure DICOM Image Server continued 2 Press Add Server on the Server Settings screen Figure 4 22 Add Server...

Page 174: ...er 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 If DICOM Image Server is of Se...

Page 175: ...succeed pop up message displays if the communication with the Server is established successfully Press OK and then Press Add to add the DICOM Image Server If communication fails check the server setti...

Page 176: ...under Server Settings If this is the first DICOM Image Server that you are adding by default it will be the favourite server If there are more than one DICOM Image Servers you have to choose the desir...

Page 177: ...d automatically from the display device after exporting it to specified DICOM Image Server To enable Auto Delete functionality follow the steps below 1 While configuring the DICOM Image Server tap on...

Page 178: ...Android 4 26 Vscan Air User Manual Direction GP092020 1EN Rev 18 Configure Network Shared Folder Follow the procedure below to configure a new Network Shared Folder 1 Press Menu Configuration Server S...

Page 179: ...Configuration Vscan Air User Manual 4 27 Direction GP092020 1EN Rev 18 Configure Network Shared Folder continued 2 Press Add Server in Server Settings screen Figure 4 27 Add Server...

Page 180: ...work Shared Folder from the drop down list of Server Type and enter the configuration information in the respective fields to add Network Shared Folder If you wish to share additional comprehensive ex...

Page 181: ...eed pop up message displays if the communication with the server is established successfully Press OK and then Press Add to add the Network Shared Folder If communication fails check the server settin...

Page 182: ...Server Settings If this is the first Network Shared Folder that you are adding by default it will be the favorite server If there are more than one Network shared folders configured then one of them...

Page 183: ...ure DICOM web server This feature allows data to be exported to a cloud based remote server using the DICOMweb STOW Store over the web protocol Follow the procedure below to configure a new DICOM web...

Page 184: ...configuration information in the respective fields to add the DICOM web server 4 Authorization is an optional feature for servers that need basic authentication using credentials 5 For DICOM web serve...

Page 185: ...OM web server continued Press OK and then Press Add to add the DICOM web server If communication fails check the server settings and make necessary corrections Figure 4 33 DICOM web server details Onc...

Page 186: ...ion for iOS and Android 4 34 Vscan Air User Manual Direction GP092020 1EN Rev 18 Remove Server 1 To remove a server from the configured list of servers Press Menu Configuration Server Settings Figure...

Page 187: ...Configuration Vscan Air User Manual 4 35 Direction GP092020 1EN Rev 18 Remove Server continued 2 Press to select the desired server that needs to be removed Figure 4 35 List of Servers...

Page 188: ...droid 4 36 Vscan Air User Manual Direction GP092020 1EN Rev 18 Remove Server continued 3 Swipe up and select Remove Server The message Do you want to delete server from list appears Press YES to delet...

Page 189: ...ally enabled replace the need to enter the data access PIN Ask for data access PIN A data access PIN can be configured to authorize access to exam data which may contain sensitive patient information...

Page 190: ...p 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 screen and Pre...

Page 191: ...92020 1EN Rev 18 Ask for data access PIN continued 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 th...

Page 192: ...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...

Page 193: ...ke 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 th...

Page 194: ...nual Direction GP092020 1EN Rev 18 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...

Page 195: ...uccessful set up of new data access PIN application takes you back to the Security screen Figure 4 46 Confirm data access PIN NOTE Please make sure to use a strong PIN and avoid using PIN codes that a...

Page 196: ...44 Vscan Air User Manual Direction GP092020 1EN Rev 18 User account User account The User account feature displays Delete user option To delete Vscan Air app user account tap on User account which di...

Page 197: ...5 Direction GP092020 1EN Rev 18 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 F...

Page 198: ...tion GP092020 1EN Rev 18 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 Ma...

Page 199: ...020 1EN Rev 18 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 Serv...

Page 200: ...Registered Vscan Air CL When registered to Vscan Air CL the support option displays App walkthrough To registered Vscan Air CL follow the steps below 4 Press Main menu Support 5 The Vscan Air CL pair...

Page 201: ...pport Vscan Air User Manual 4 49 Direction GP092020 1EN Rev 18 Support Registered Vscan Air CL continued 7 Select Do not show again to close the App walkthrough details Figure 4 53 Close App walkthrou...

Page 202: ...app functions Figure 4 54 App walkthrough functionality 1 Freeze the scan screen by tapping anywhere on scan area 2 Tap on scan and move vertical to change the depth 3 Tap on scan and move horizontal...

Page 203: ...092020 1EN Rev 18 Diagnostics 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 Diagnos...

Page 204: ...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...

Page 205: ...anual 4 53 Direction GP092020 1EN Rev 18 About About The About option displays Registered devices App version info Probe version info Regulatory Account information Acknowledgements and Export audit l...

Page 206: ...ying the connected probe is displayed 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 w...

Page 207: ...re 4 60 App version info example Probe version info Probe version info Displays Probe software version and Probe software revision Figure 4 61 Probe version info example NOTE The UDI information and t...

Page 208: ...id 4 56 Vscan Air User Manual Direction GP092020 1EN Rev 18 About continued Regulatory Figure 4 62 Regulatory Account information 1 Press the Account information tab Figure 4 63 Account Information 1...

Page 209: ...4 57 Direction GP092020 1EN Rev 18 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...

Page 210: ...Manual Direction GP092020 1EN Rev 18 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...

Page 211: ...Air User Manual 4 59 Direction GP092020 1EN Rev 18 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 Expor...

Page 212: ...Vscan Air Configuration for iOS and Android 4 60 Vscan Air User Manual Direction GP092020 1EN Rev 18...

Page 213: ...ge 5 2 Scanning on page 5 4 Measurements on page 5 50 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 servic...

Page 214: ...092020 1EN Rev 18 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 Figure 5 1 Left panel See Probe and P...

Page 215: ...exam access current exam and data from previously saved exams Figure 5 2 Right Panel Start a new exam Press New Exam on right corner at the bottom of the screen to start a new exam Current exam Displ...

Page 216: ...quired disinfect the Vscan Air CL see Cleaning and disinfection on page 6 6 Ensure that the Vscan Air CL is properly cleaned and disinfected after each use and before storing in the protective case Us...

Page 217: ...ion regarding probe care refer to the website https gehealthcare com probecare or https www gehealthcare com products ultrasound ultrasound transducers Table 5 1 Compatible Gels Aquasonic Parker Labor...

Page 218: ...Standards on page i 4 under any operating condition described in this user manual see Environmental requirements for Vscan Air CL on page 3 8 To help keeping the Vscan Air CL operating temperature at...

Page 219: ...mark is used to identify the side of the Vscan Air CL probe corresponding to the side of the image having the orientation V mark on the scanning screen A steady blue LED light on one end of the Vscan...

Page 220: ...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 awa...

Page 221: ...t is important to visualize the entire width it is possible to do one of the below 1 Rotate the display device to visualize the image in landscape orientation 2 If portrait mode is preferred The depth...

Page 222: ...ed every time the Vscan Air CL pairs successfully with the Vscan Air app and also every time the Vscan Air App is started 2 Manually A new exam can be created manually at any time by selecting new exa...

Page 223: ...am will get saved when an image or video is stored for that exam NOTE 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 neede...

Page 224: ...ucer and preset combination before scanning Table 5 2 Curved array deep scanning transducer presets Curved array transducer Preset Optimized for Abdominal Liver Gall bladder and biliary tree Pancreas...

Page 225: ...ets Linear array transducer Preset Optimized for Vascular Veins Arteries Nerves Peripheral nerves Small Parts Small organs Pediatric recommended minimum weight 4 kg Soft tissue MSK Musculoskeletal sup...

Page 226: ...lable 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 Figure 5 7 Preset menu 2 Select the d...

Page 227: ...ion GP092020 1EN Rev 18 To set a preset as default 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 defaul...

Page 228: ...nnected to a Vscan Air app Black and white imaging is intended to provide two dimensional images and measurement capabilities concerning the anatomical structure of soft tissue Black and white imaging...

Page 229: ...ing or darkening the image if sufficient echo information is generated 1 Swipe at least half a centimeter from the left or right on the scan screen to initiate a gain change Figure 5 10 Drag NOTE Smal...

Page 230: ...varies as well Turn ON or OFF the TGC Controls from the Menu screen The TGC controls are displayed on the scan screen as soon as you start adjusting gain by sliding your finger on any part of the imag...

Page 231: ...line 1 Swipe your finger up down on the screen at least half a centimeter to initiate depth Figure 5 13 Depth adjustment NOTE Small movements will be ignored to avoid unintentional activation of the...

Page 232: ...the image in the direction where you want the zoomed area to move Figure 5 14 Pinch An indicator will be displayed on the image whenever Zoom is activated to help recognize a zoomed image easily Zoom...

Page 233: ...ooming one or both edges of the image may go out of the field of view on the screen In such cases you will see Image crop indicators appear on the sides where the image edge is not visualized Refer Im...

Page 234: ...etting optimized for high resolution imaging balancing adequate penetration for average sized patients Penetration setting is useful for imaging at greater depths by optimizing visualization of struct...

Page 235: ...solution default and Penetration settings tap on the The icon indicates that the Penetration setting is selected and icon indicates default or Resolution setting is selected Depth is maintained while...

Page 236: ...coded qualitative information concerning the relative velocity in m s and direction of fluid motion within the black and white image 1 Press the Color icon A color flow area displays on top of the bl...

Page 237: ...as long as the TGC controls are active Color Gain Color gain amplifies the overall strength of echoes processed in the color area 1 Swipe at least half a centimeter from the left or right on the scan...

Page 238: ...Keep the box sized just to the anatomy of interest and as close to center as possible Drag your finger inside the ROI to move and position The box turns blue indicating that the controls for adjustin...

Page 239: ...versa Positive velocity indicates flow towards the transducer and negative indicating flow away from the transducer The maximum velocity or Nyquist limit is displayed on top of the velocity bar Fast a...

Page 240: ...change the velocity scale tap on the to alternate between the velocity scales The indicates that the higher velocity scale is selected and indicating the lower scale The velocity setting corresponding...

Page 241: ...age 1 Press Freeze icon again OR Tap anywhere on the image Video buffer Video buffer displays with an ability to scroll play and pause the frames in the video buffer The indicator is placed on the las...

Page 242: ...g Vscan Air CL 5 30 Vscan Air User Manual Direction GP092020 1EN Rev 18 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 i...

Page 243: ...ng a video To store a video 1 Press the Store button on the scan screen when the image is live OR 2 Play the video buffer by using the Play button on the video scroll bar and then press Store Press St...

Page 244: ...sign patient Study information from a scheduled exam retrieved from the Modality Worklist Server Assign Patient data manually to the current exam To assign patient details manually to the current exam...

Page 245: ...he required information in the respective fields under New Patient screen Press Add button to assign Patient data to the current exam After successful assignment of Patient data application takes you...

Page 246: ...92020 1EN Rev 18 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 Pres...

Page 247: ...ev 18 Assign Patient data manually to an existing Exam To assign patient details manually to an existing exam in Vscan Air application follow the procedure below 1 Swipe from right to left OR Press Pa...

Page 248: ...ient 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 individ...

Page 249: ...er and enter the required information in the respective fields under New Patient screen Press Add button to assign Patient data to the existing exam After successful assignment of Patient data applica...

Page 250: ...1EN Rev 18 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...

Page 251: ...ient pulled from the worklist prior to exporting to the DICOM image server To assign Patient data from a modality worklist server to the current exam in the Vscan Air application follow the procedure...

Page 252: ...ser Manual Direction GP092020 1EN Rev 18 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 Patie...

Page 253: ...nt exam in one of the following ways a Tap on the desired Patient Name Patient ID from the imported list of patients OR b Make a local search to find the details of a particular patient from the impor...

Page 254: ...the imported list of records and clears the remote search results Figure 5 34 Worklist NOTE Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connect...

Page 255: ...to the current exam After successful assignment of Patient data application takes you to the scan screen Patient s Last Name First Name and ID are shown on the top of the scan screen Figure 5 35 Add...

Page 256: ...patient pulled from the worklist prior to exporting to the DICOM image server To assign Patient data from a modality worklist server to an existing exam in the Vscan Air application follow t he proce...

Page 257: ...anual 5 45 Direction GP092020 1EN Rev 18 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 d...

Page 258: ...User Manual Direction GP092020 1EN Rev 18 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 Patien...

Page 259: ...nt exam in one of the following ways a Tap on the desired Patient Name Patient ID from the imported list of patients OR b Make a local search to find the details of a particular patient from the impor...

Page 260: ...the imported list of records and clears the remote search results Figure 5 40 Worklist NOTE Make sure that the display device hosting Vscan Air app and the PC in which server is configured are connect...

Page 261: ...the existing exam After successful assignment of Patient data application takes you to the scan screen Patient s Last Name First Name and ID are shown on the top of the scan screen Figure 5 41 Add pa...

Page 262: ...images in both black and white and color imaging Up to four distance measurements can be performed on an image Measurements can be done during image review or on recalled stored images To perform a d...

Page 263: ...on again to make additional measurements on the displayed image Up to 4 distance measurements can be made on a single image To delete a distance measurement 1 Select the measurement you wish to delete...

Page 264: ...urement 3 To store the image with a measurement press store NOTE Only a single ellipse measurement can be performed on the displayed image To delete an ellipse measurement 1 Select the measurement 2 P...

Page 265: ...ght to left OR Tap on Patient icon on the top right corner Images and video loops captured in current exam is shown 2 Select to activate and review stored images Figure 5 44 Recalled stored image 1 Im...

Page 266: ...to go to the viewer The viewer opens with selected image and the Exam list closes The freeze button becomes active You can unfreeze to continue scanning using the current exam Delete images videos Yo...

Page 267: ...t log is essentially a record of events and changes Audit logs typically capture events by recording who performed an activity what activity was performed and how the system responded Audit logs are a...

Page 268: ...ed 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 ca...

Page 269: ...g file using an iOS device iPhone or iPad it will replace any already stored audit log file If the audit log file or the Vscan folder is kept open in the background the new file appears as another fil...

Page 270: ...the user to export and or delete exams as needed once the number of stored exams are 480 or higher The user should make sure to export images videos loops or exams to an external storage device via t...

Page 271: ...rection GP092020 1EN Rev 18 Share individual images videos 1 Swipe from right to left OR Press Patient icon button on the top right corner A list of stored images or videos for the current exam displa...

Page 272: ...CL 5 60 Vscan Air User Manual Direction GP092020 1EN Rev 18 Share individual images videos continued 2 Select the desired exam or video you wish to share Figure 5 50 Select desired Exam 1 Select one...

Page 273: ...Export data Vscan Air User Manual 5 61 Direction GP092020 1EN Rev 18 Share individual images videos continued 3 Press Share icon Figure 5 51 Share with other apps...

Page 274: ...ages 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 1 Press Exams tab on the right panel 2 Select the de...

Page 275: ...xams list 3 Press Share icon 4 Choose the Share function on your display device to share the entire single multiple Exams Export data to the DICOM Image Server To export images videos exams from Vscan...

Page 276: ...L 5 64 Vscan Air User Manual Direction GP092020 1EN Rev 18 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 Figu...

Page 277: ...Share individual images videos on page 5 59 for more information OR Select all images or videos you wish to export and Press the Share icon See Share all images videos from an exam on page 5 62 for mo...

Page 278: ...e export If there are more than one DICOM Image servers select the desired DICOM Image Server as storage destination Figure 5 56 Share Images Videos NOTE You can also select all the configured servers...

Page 279: ...ver continued 5 You can see the image queue at the bottom with items remaining to be exported In addition to image queue you can also view export status for each image video exam where a green dot ind...

Page 280: ...e than 200 images in a single attempt application throws the following warning message Figure 5 58 Export limit warning message NOTE The application initiates an Auto Retry in case of a failed export...

Page 281: ...e 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...

Page 282: ...Using Vscan Air CL 5 70 Vscan Air User Manual Direction GP092020 1EN Rev 18 Secure DICOM continued 2 Under Secure DICOM select the desired Security Profile Figure 5 60 Select Security Profile...

Page 283: ...xport data Vscan Air User Manual 5 71 Direction GP092020 1EN Rev 18 Secure DICOM continued 3 Press the Add Server Certificate button to upload the server certificate Figure 5 61 Add Server Certificate...

Page 284: ...Vscan Air CL 5 72 Vscan Air User Manual Direction GP092020 1EN Rev 18 Secure DICOM continued 4 Press the Add Client Certificate button to upload the Client certificate Figure 5 62 Upload Client Certif...

Page 285: ...anual 5 73 Direction GP092020 1EN Rev 18 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 certificate...

Page 286: ...20 1EN Rev 18 Export data to the Network Shared Folder To export images videos exams from Vscan Air application to Network Shared Folder follow the procedure below 1 Swipe from right to left OR Press...

Page 287: ...an Air User Manual 5 75 Direction GP092020 1EN Rev 18 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...

Page 288: ...See Share individual images videos on page 5 59 for more information OR Select all images or videos you wish to export and Press the Share icon See Share all images videos from an exam on page 5 62 f...

Page 289: ...stination Figure 5 67 Share Images Videos NOTE You can also select all the servers simultaneously if you wish to share the data with all the servers that supports data exporting NOTE You can export im...

Page 290: ...one attempt you can export maximum of 200 images When you try to export more than 200 images in a single attempt application throws the following warning message Figure 5 69 Export limit warning mess...

Page 291: ...am If only Patient ID is assigned to an exam the network shared folder structure appears as below after exporting to your PC The images and videos are stored in a series of folders Folder Shared folde...

Page 292: ...an exam If Patient ID First Name and Last Name are assigned to an Exam the Network Shared Folder structure appears as below after exporting to your PC The media files are stored in a seriesof folders...

Page 293: ...home healthcare environments 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 NOTE The Vscan Air probe is not...

Page 294: ...additional functionality Store or Freeze that can be helpful during an emergency exam to minimize interaction with the display device It can be configured from the Menu Configuration Probe button Not...

Page 295: ...selected Vscan Air probe and the preferred display device should be tested in an environment as close as possible to the environment where the service is to be provided If an internet connection is n...

Page 296: ...ice is configured to NOT accept automatic OS updates Perform a monthly check for Vscan Air app updates if the display device is configured to NOT accept automatic app updates NOTE If an App update is...

Page 297: ...ly negative adverse effect on the patient s health outweighing the benefits of using an ergonomic wireless probe at the point of care it is recommended to consider using a wired ultrasound device for...

Page 298: ...onfiguration This will help to visualize discontinuities in loop playback which indicate lost frames 2 Connect probe and app Connect the probe with the app 3 Select preset with color Select Small Part...

Page 299: ...cted challenges with a stable connection between the probe and app before the actual procedure Make sure to follow the disinfection protocol to prepare the probe and display device for the procedure b...

Page 300: ...and biopsy and needle procedures so the centerline marking should not be confused with biopsy guidelines indicating needle path on the image The probe button can be configured for additional functiona...

Page 301: ...obe temperature Ensure that the connection between the probe and app is stable by checking the connection quality indicator on the top left corner of the imaging screen The probe temperature indicator...

Page 302: ...ise 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 MyDeviceHub can be purchased as par...

Page 303: ...not authorized to use the connected probe the following error will be displayed In this case the user may choose to use a different Vscan Air CL probe or contact the Enterprise administrator to updat...

Page 304: ...gurations 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...

Page 305: ...ration settings from backend If user choses to accept the configuration the server settings will be updated in the application The user can also download server configurations from the backend wheneve...

Page 306: ...m 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 informat...

Page 307: ...al 5 95 Direction GP092020 1EN Rev 18 DICOM Server Configuration continued If the received configuration is incomplete then the following indication will be shown to user Figure 5 74 Server configurat...

Page 308: ...is provided for education training and support purposes It is not intended for diagnostic use since the quality of the image feed seen by the remote participant will depend on the user s and participa...

Page 309: ...on Vscan Air is available only on the Android platform The annotation option needs to be enabled on the host side to ensure that the annotations on the remote participant side are available NOTE Pleas...

Page 310: ...ir CL 5 98 Vscan Air User Manual Direction GP092020 1EN Rev 18 Usage of MyRemoteShare 1 Press the Menu Select Start screen share session from MyRemoteShare tab on the Preset menu Figure 5 75 Activate...

Page 311: ...n GP092020 1EN Rev 18 Usage of MyRemoteShare continued 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 mus...

Page 312: ...2020 1EN Rev 18 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 c...

Page 313: ...Direction GP092020 1EN Rev 18 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 mobil...

Page 314: ...tion GP092020 1EN Rev 18 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 j...

Page 315: ...ant side there is a static banner throughout the screen share session which indicates that screen share is intended for non diagnostic use Figure 5 80 Non diagnostic banner on the participant side not...

Page 316: ...age of MyRemoteShare continued 9 The host can enable disable audio video during the remote session Figure 5 81 MyRemoteShare session 10 The host can annotate on the scan screen during the remote sessi...

Page 317: ...GP092020 1EN Rev 18 Usage of MyRemoteShare continued 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 rotat...

Page 318: ...N Rev 18 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 Figure 5 83 Add Remove participants 1 Ad...

Page 319: ...on GP092020 1EN Rev 18 Usage of MyRemoteShare continued 13 The host can end the remote session Figure 5 84 End the session 1 End call 2 Toggle screensharing on off 3 Toggle Host camera on off 4 Mute H...

Page 320: ...cking 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 micr...

Page 321: ...management 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...

Page 322: ...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...

Page 323: ...thcare 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 MyImageClo...

Page 324: ...Using Vscan Air CL 5 112 Vscan Air User Manual Direction GP092020 1EN Rev 18...

Page 325: ...ev 18 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...

Page 326: ...ording to the requirements of the patient safety standard EN ES IEC 60601 1 and its national deviations or according to the requirements of the IEC62353 standard medical electrical equipment recurrent...

Page 327: ...ny issue may have occurred Equipment for cracks loose or missing hardware Before each use 1 Inspect the lens and the probe housing 2 Look for damage that might allow liquid into the probe 3 Test the f...

Page 328: ...interests of every ultrasound user to routinely monitor equipment performance Typical Tests to Perform Quality assurance measurements provide results relating to system performance Typically these are...

Page 329: ...were exposed to the patient or the user in such a way that a closed electrical circuit could be created For the operator or patient to gain access to one or two live parts the plastic housing of the...

Page 330: ...Example https support apple com en us HT204172 Please be aware that medical grade display devices often support a wider range of cleaners and disinfectants compared to display devices for the consume...

Page 331: ...emicals Used for Efficacy Validation The table below lists the products and intended use cleaning Intermediate level disinfection high level disinfection that were validated with the Vscan Air CL prob...

Page 332: ...e in the trophon chamber Refer to the manufacturer s instructions for use when using the trophon EPR or trophon2 devices GE offers this holder as an accessory to the Vscan Air GE Healthcare has not va...

Page 333: ...ducers from the lens of one transducer to the other Dispose the cloth wipe and gloves in the clinical trash 3 After each use inspect the lenses and housing of the Vscan Air CL Look for any damage that...

Page 334: ...Vscan Air CL and wipe the surface of the Vscan Air CL As the wipe becomes visibly soiled discard the wipe into clinical trash and dispense fresh wipes as needed 5 Wrap a clean wipe around a soft nylo...

Page 335: ...the minimum contact time listed on the enzymatic cleaner label Make sure to follow manufacturers recommendations 5 Visually inspect the probe and probe components for soil Repeat steps 4 6 until all v...

Page 336: ...fter each wiping pass 6 Wrap a clean wipe around a soft nylon bristle brush to access crevasses on the surface of the Vscan Air CL Do not use the brush on the Vscan Air CL lenses 7 Once the Vscan Air...

Page 337: ...or use Be sure to follow all precautions for storage use and disposal Observe specifically soak times and dilution rates 2 Immerse cleaned and dried probe in the disinfectant for the time specified by...

Page 338: ...n for Professionals in Infection Control APIC the U S Food and Drug Administration FDA and the U S Centers for Disease Control CDC For country specific disinfection regulations check with your local r...

Page 339: ...cover tightly over Vscan Air CL face to remove wrinkles and air bubbles taking care to avoid puncturing the sheath Figure 6 1 Applying the Sheath 3 Secure the sheath in place NOTE If using a rubber ba...

Page 340: ...en cleaning the protective case pay special attention to its edges and grooves Requirements for the protective case cleanliness will be defined by the way the protective case is implemented in the wor...

Page 341: ...ed with the chemicals specified in Chemicals used for Efficacy Validation with Vscan Air CL on page 6 7 GEHC ultrasound transducers web site https gehealthcare com probecare OR https www gehealthcare...

Page 342: ...mages caused by cleaning disinfection or gel products that are not compatible with GE probes Table 6 2 Chemicals compatible with the Vscan Air CL probe Trade Name Manufacturer Cidezyme Enzol Advanced...

Page 343: ...mpact the performance safety or lifetime of the probe If color change occurs due to disinfection in trophon chamber Vscan Air probes will not be repaired or replaced under warranty or contract agreeme...

Page 344: ...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 F...

Page 345: ...nual 6 21 Direction GP092020 1EN Rev 18 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 upd...

Page 346: ...Vscan Air Maintenance 6 22 Vscan Air User Manual Direction GP092020 1EN Rev 18 Vscan Air CL probe software upgrade continued 2 The probe update is in progress...

Page 347: ...092020 1EN Rev 18 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...

Page 348: ...be cross contamination water and dust particulate can enter inside the probe causing degradation in performance Contact GEHC Service see Contact Information on page 1 12 Degrading image quality Could...

Page 349: ...18 Not able to pair with probe Probe may already be connected to a different instance of the app Turn ON the probe and press probe button If issue persists Contact GEHC Service see Contact Informatio...

Page 350: ...e Contact Information on page 1 12 Defective USB cable Contact GEHC Service see Contact Information on page 1 12 Mains power is down Ensure that the charger is connected to a powered wall outlet Tempe...

Page 351: ...found pairing initiated but connection fails and the probe shuts down The probe battery level is too low Place the probe on the charger and try again when sufficiently charged 3 When connecting to an...

Page 352: ...re is an issue with networking on the Android device Close the app open Settings and navigate to the Wi Fi Direct panel Depending on the manufacturer of the Android device the Wi Fi direct panel is fo...

Page 353: ...When you are on the Wi Fi direct panel you should see a list of Peer Devices or Available devices or something similar Select the device that matches your probe VAXXXXXXXXX to disconnect 8 When attem...

Page 354: ...primary channel for iOS devices and choosing a different one may solve the throughput issue An Android device connected to an existing network prior to pairing with the probe might negotiate with the...

Page 355: ...ev 18 Steps to troubleshoot Network shared folder connectivity challenges 1 Lack of permission for network shared folder on windows PC Step 1 Right click on the folder and select Properties Go to Shar...

Page 356: ...can Air Maintenance 6 32 Vscan Air User Manual Direction GP092020 1EN Rev 18 Steps to troubleshoot Network shared folder connectivity challenges continued Step 3 Click on Permissions Step 4 Click on A...

Page 357: ...on Advanced and click Find now Observe that list of user group shows up below in Search results Step 6 Search for your user name and select Also select Administrators and Authenticated users in the l...

Page 358: ...ed in the backend a b Retry the workflow when the internet connection is available If issue persists Contact GEHC Service see Contact Information on page 1 12 c For password refer Password Guidelines...

Page 359: ...or Storage or MWL servicer Contact hospital IT staff to find the root cause and can resolve the issue by addressing root cause Configuration details such as IP address port AE title can be incorrect...

Page 360: ...get scheduled Exam list from MWL Network availability for device Wi Fi to transfer Contact hospital IT staff to find the root cause and can resolve the issue by addressing root cause Incorrect configu...

Page 361: ...Air User Manual 6 37 Direction GP092020 1EN Rev 18 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...

Page 362: ...st 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...

Page 363: ...Diagnostics Vscan Air User Manual 6 39 Direction GP092020 1EN Rev 18 Diagnostics Test continued Figure 6 5 Diagnostics Process...

Page 364: ...Vscan Air Maintenance 6 40 Vscan Air User Manual Direction GP092020 1EN Rev 18 Diagnostics Test continued 5 If the Diagnostics test passes the below screen displays Figure 6 6 Diagnostics Passed...

Page 365: ...C for instance if diagnostic test fails Figure 6 7 Diagnostics Failed 6 GEHC service guides the customer through the procedure to upload the system log file NOTE System logs exported from the device w...

Page 366: ...system logfile The transducer element test is part of the probe diagnostics test which is found via the app Menu Diagnostics Run Diagnostics The element test is then executed as part of a predefined t...

Page 367: ...ge critical Connectivity error WARNING Probe is overheating and the system will shut down If the problem persists contact GEHC WARNING Battery critically low Connect charger immediately WARNING Probe...

Page 368: ...shipping or returning to GEHC If the battery does not charge or if it is damaged Contact GEHC for battery replacement Automatic deactivation of the Vscan Air app Deactivation soft limit The Vscan Air...

Page 369: ...ion 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: ...P092020 1EN Rev 18 Chapter 7 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...

Page 372: ...system and information from risks to confidentiality integrity and availability Security protects Privacy but also protects more broadly against these risks Privacy requires security In Healthcare on...

Page 373: ...ess control features may be used to help control access to sensitive information User based access controls are provided by iOS and Android OS Vscan Air product is based on a bring your own mobile dev...

Page 374: ...irements Host Characteristic 1 TCP IP network 2 Both DHCP and static IP allocation are supported Network Protocols Wireless network protocols The following wireless protocols are supported 1 IEEE 802...

Page 375: ...hout an Information Technology system that addresses personnel physical security and technology The layered approach of defense in depth limits the risk that the failure of a single security safeguard...

Page 376: ...xample Vscan Air should not be connected to an unsecured wireless network Wireless security protocols The following security protocols are supported on the wireless interface 1 WPA WPA2 PSK 2 802 1x E...

Page 377: ...should be considered 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 funct...

Page 378: ...ommended to minimize the use of your display device as a non clinical host Host OS and other host software negative compatibility Ensure that Vscan Air CL probe software and the Vscan Air App software...

Page 379: ...ation 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 VP...

Page 380: ...cted for the purposes of patient medical diagnosis user management and or debug logging 1 Ultrasound images with optional measurements 2 Stored images will hold date and time 3 Equipment owner informa...

Page 381: ...information or patient data 3 Corruption of images or other exam information or patient data Warning In addition to the hazardous situations identified above connection of the Vscan Air to a network t...

Page 382: ...Privacy and Security 7 12 Vscan Air User Manual Direction GP092020 1EN Rev 18...

Page 383: ...al 8 1 Direction GP092020 1EN Rev 18 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...

Page 384: ...y transducer for deep scanning Broad bandwidth curved array from 2 5 MHz with center frequency of 3 3 MHz Number of elements 128 Footprint 64 mm x 16 mm lens Viewing angle 60 Depth up to 24 cm Linear...

Page 385: ...ue 1 C The displayed TI is an estimate of temperature increase of soft tissue or bone presented to make it easier for the operator to implement the ALARA As Low As Reasonably Achievable principle Ther...

Page 386: ...ing order TIS TIC TIB starting out from the factory selected TI category for the selected preset Figure 8 1 Thermal Index display NOTE Be aware that Figure 8 1 is illustrating the TI value display uti...

Page 387: ...arameters and compares them to the FDA limits Output levels remain below the limits with a 95 confidence margin The absolute maximum allowable output for all applications is ISPTA less than or equal t...

Page 388: ...s setup and prevents start of scanning The system has monitoring of voltage and power used by the ultrasound transmits circuitry and probe If transmit voltage or power exceeds expected values the tran...

Page 389: ...one Thermal Index at surface scanning or non scanning TIBbs Bone Thermal Index below surface scanning or non scanning TIC Cranial bone Thermal Index pr Attenuated peak rare factional acoustic pressure...

Page 390: ...Appendix 8 8 Vscan Air User Manual Direction GP092020 1EN Rev 18 Operating Conditions All table entries are with the operating conditions specified at the end of the table...

Page 391: ...reporting tables are produced according to IEC 62359 Ed 2 NOTE The Acoustic Output tables are in English only Transducer Model Curved array transducer Operating Mode black and white including harmoni...

Page 392: ...ansducer Model Curved array transducer 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...

Page 393: ...P092020 1EN Rev 18 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 doe...

Page 394: ...ev 18 Transducer Model Linear array transducer Operating Mode black and white including harmonic and color Figure 8 5 Linear array transducer black white including harmonic and color NOTE This transdu...

Page 395: ...N Rev 18 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 opt...

Page 396: ...ducer Model Linear array transducer 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 n...

Page 397: ...pregnancy the American Institute of Ultrasound In medicine herein addresses the clinical safety of such use No confirmed biological effects on patients or instrument operators caused by exposure at in...

Page 398: ...nt accuracy a quality assurance QA plan should be established for the equipment that includes routine accuracy checks with tissue mimicking phantoms Please be advised that all distance related measure...

Page 399: ...Sound in Tissue 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 pr...

Page 400: ...Transducer Clinical Application Anatomy Evaluation Abdominal Adult Pediatrics Gall bladder biliary tree common bile duct Liver Pancreas Spleen Bowel including Appendix small bowel loops Abdominal aort...

Page 401: ...thorax and hemothorax Pleural Effusion Lung consolidation Pneumonia pneumonitis Pulmonary fibrosis Pulmonary interstitial and inflammatory disorders Ex ILD COPD Acute respiratory distress syndrome Car...

Page 402: ...ement and monitor position of tubes and catheters Protocols Heart IVC Lungs Abdomen FAST eFAST BLUE FASH FASE Table 8 3 Curved Array Transducer Clinical Application Anatomy Evaluation Table 8 4 Linear...

Page 403: ...al and conventional Adult Pediatrics Tendons Muscles Ligaments Nerves Long bones ex Humerus Radius Ulna Femur Tibia Fibula Joints Ankle Shoulder Knee Elbow Wrist Joint space bursa Tendon injuries tend...

Page 404: ...t and support of dialysis access Nerve blocks Joint aspiration and injections Cyst aspiration Biopsy Abscess drainage Foreign body visualization localization Lumbar Puncture Endotracheal tubes placeme...

Page 405: ...24 Inspection 6 3 M Maintenance 6 1 Measurements 5 50 N Network Connectivity 7 5 P Package contents 3 2 Patient examination 5 10 Preparing for Use 3 1 Privacy and Security 7 1 prudent use 2 2 R Regula...

Page 406: ...Index 2 Vscan Air User Manual Direction GP092020 1EN Rev 18...

Page 407: ......

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