Vave Personal Ultrasound USER MANUAL
Vave Personal Ultrasound • U S E R M A N UA L User Manual – Vave Personal Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Target Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Document Conventions. .
Vave Personal Ultrasound • U S E R M A N UA L 3.5 Account Creation, Signing In & Out. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 3.5.1 Creating Account. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.5.2 Signing In — Two-Factor-Authentication. . . . . . . . . . . . . . . . . . . . . . . . 22 3.5.3 Signing Out. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vave Personal Ultrasound • U S E R M A N UA L 6 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 6.1 Compliance Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 6.2 The Vave Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 6.2.
Vave Personal Ultrasound • U S E R M A N UA L About This Manual This document is licensed as part of the purchase of the Vave Personal Ultrasound System and is intended to meet FDA regulatory requirements. Install, operate, and maintain the Vave Personal Ultrasound according to the safety and operating procedures in this manual, and only for its intended purpose. Always use the information in this document with sound clinical judgment and best clinical procedures.
Vave Personal Ultrasound • U S E R M A N UA L 1 About the Vave Personal Ultrasound The Vave Personal Ultrasound is subject to the laws in the jurisdiction in which it is used. Install, use, and operate the product only in ways that adhere to applicable laws or regulations. • Keep product packaging with medical device. Do not dispose.
Vave Personal Ultrasound • U S E R M A N UA L The Vave Phased contains a removable lithium ion battery. The battery is charged through the provided charger. Battery Specifications: Battery manufacturer Vave Battery type/chemistry Lithium ion Battery model number VBT Battery management Fuel gauge with protection circuitry and temperature monitoring Battery life 500 cycles Charger Input: 100-240 VAC, 50/60 Hz, 1.0-0.6 A Output: 12 VDC, 2.5 A Battery 3.
Vave Personal Ultrasound • U S E R M A N UA L Clinical Application General (Track 1 Only) Ophthalmic Specific (Tracks 1 & 3) Mode of Operation B M PWD CWD Color Doppler Combined (Specify) Other* (Specify) Ophthalmic Fetal N Abdominal N Intra-operative (Specify) Intra-operative (Neuro) Laparoscopic Pediatric N Small Organ (Specify) Neonatal Cephalic Fetal Imaging & Other Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.
Vave Personal Ultrasound • U S E R M A N UA L For Use in Surgical Environments Before you use the Vave Probe for intra-operative procedures, follow the instructions for high-level disinfection (for instructions see page 32), then cover the Vave Probe with a sterile sheath: • Use only CIVCO REF 610-1212. • Download the usage instructions from http://civco.com and read all the information before use.
Vave Personal Ultrasound • U S E R M A N UA L 1.4 Hardware 1.4.1 Warranty Your Vave Probe includes a one-year warranty. To purchase an extended warranty, go to www.vavehealth.com. 1.4.2 Disposal Vave Probe equipment and accessories are designed and manufactured in alignment with environmental protection standards. Disposal should follow the same standards. Vave Probe materials required for quality treatment and functionality can be environmentally hazardous if improperly disposed.
Vave Personal Ultrasound • U S E R M A N UA L Security Updates The Vave Platform restricts device firmware updates to authorized software distributed through the Vave Health Mobile App. It is your responsibility to upgrade the Vave Probe and Firmware as described in the “Updating the Vave Probe” section of this manual. In addition, it is your responsibility to upgrade and apply operating system and security updates to your mobile device. iOS Operating System Updates 1.
Vave Personal Ultrasound • U S E R M A N UA L Encryption The Vave App automatically encrypts information and images contained within the Vave App. For additional protection, we recommend enabling device encryption to help ensure all data stored on the system is protected and increase the strength of your access-control, rendering data unrecoverable by unauthorized users.
Vave Personal Ultrasound • U S E R M A N UA L 1.5.5 Availability Images and cines are maintained in the Vave Health App until they are deleted by the user. After a large number of images are stored, the device storage may become full, requiring image deletions before storing additional images. The Vave App requires an internet connection to register a new user and/or Vave Phased Array Probe.
Vave Personal Ultrasound • U S E R M A N UA L 2 Quick Tour 2.1 Interface and Screens Overview 2.1.1 Icons Icons are used throughout the app to visually guide users.
Vave Personal Ultrasound • U S E R M A N UA L 2.1.2 Alerts and Notifications Use the table below to identify and understand alerts displayed in the Vave interface. Vave Interface Alerts Password is Required If user does not enter the password, a password required validation will appear under the password input. Wrong Email Format If input entry does not support email format, a wrong email format validation will appear under the password input.
Vave Personal Ultrasound • U S E R M A N UA L Required Update If there is a required update for the probe available, you will see a required update alert. Optional Update If there is an optional update for the probe available, you will see an optional update alert. Update Failed Update Failed alert shows up if the update process of the probe has not ended successfully.
Vave Personal Ultrasound • U S E R M A N UA L Forgot Password: Enter your email to receive a verification code to be entered on your phone so you can reset your password. 2.1.
Vave Personal Ultrasound • U S E R M A N UA L 2.1.
Vave Personal Ultrasound • U S E R M A N UA L 2.1.7 Presets This screen allows you to choose from the following preset options: • Cardiac • Abdominal • Lung • OB/GYN 2.1.8 Imaging Page This screen displays the image and allows the user to manipulate the visualization of the anatomy (depth, gain) — and freeze or save images/movie clips. 2.1.9 Review Page/Gallery When you have finished imaging, you can evaluate and edit images and cines that were acquired during the exam. CONFIDENTIAL & PROPRIETARY.
Vave Personal Ultrasound • U S E R G MUAINDUA E L 3 Using The Vave Probe This chapter explains how to install and use your Vave Probe safely and effectively. Refer to to the safety section of this manual before handling the Vave Probe. ! Ensure your mobile device requires a passcode, PIN, pattern or biometric identification for access. We recommend configuring the device to lock after a maximum of 15 minutes of inactivity. ! Ensure your mobile device follows your institution’s security policy. 3.
Vave Personal Ultrasound • U S E R M A N UA L 3.3 Inserting & Removing Battery For more information regarding battery maintenance please refer to hardware maintenance section of this manual. 3.3.1 Inserting the Battery To insert the battery into the Vave Probe: 1. Make sure that the battery contacts are facing downward and that the battery label is facing the Vave Probe. 2. Slide the battery into the Vave Probe until it locks into place. STONE – Alternate orientation BOX CLEVER INC.
Vave Personal Ultrasound • U S E R M A N UA L 3.5 Account Creation, Signing In & Out 3.5.1 Creating Account Upon opening the Vave App you’ll see the Registration screen. 1. Enter an Email address and password. These will be used for each sign in. 2. Read and agree to the Terms of Service and Privacy Policy. 3. Enter a phone number (with country code). This will be used to send verification codes for two-factor authentication. 4.
Vave Personal Ultrasound • U S E R M A N UA L 3.5.4 Forgot Password To reset your password, open the “Forgotten password?” option on the sign-in screen. Enter the email address you used to sign up. A verification code will be sent to your phone via text message. You will then be able to enter a new password. 3.6 Organizations In order to perform exams you have to be a member or admin of an organization. At first, the Organization Screen will appear empty.
Vave Personal Ultrasound • U S E R M A N UA L 3.6.1 Organization Settings To manage organization settings/view organization information you must tap on three dots that appear next to the organization name. The following screen will appear with the following options: • Change organization name (only if you are the admin) • View details of Admins and Members by tapping on their name • Invite new members to organization After tapping on a selected member’s name a Member Details Page will appear.
Vave Personal Ultrasound • U S E R M A N UA L Cardiac Orientation: By default the probe marker on the ultrasound image for the cardiac preset is on the right side. Here you can change the probe marker to the left side. In the About Section, you can view your App version, and — if connected to your Vave Probe — also the Firmware version and registration date of your probe. These settings are reset to default when the app is closed, i.e., they are retained only as long as the app is running. 3.6.
Vave Personal Ultrasound • U S E R M A N UA L 3.8.1 Connecting Android Device to Vave Probe 1. Open the App 2. In the “Scan” page, choose “Shortcuts to Wi-Fi settings” under Connect Probe 3. This will direct you to a list of available Wi-Fi networks. Select the Wi-Fi network beginning with “VAVE-VP3” and return to the App 3.8.2 Connecting iOS Device to Vave Probe 1. Open the App 2. In the “Scan” page, choose “Go to Wi-Fi Settings” 3. This will direct you to the list of your available Wi-Fi networks.
Vave Personal Ultrasound • U S E R M A N UA L Do not use: X Lotion-based products or gels containing mineral oil X Hand-sanitizing gels X Scanners left soaking in gel 3.9.1 Starting New Exams Once the probe is connected • Go to the Scan tab • Choose “Start New Exam” • Select “Pick a Scan Preset” – After the “Connecting to Probe” screen establishes a connection, use the imaging screen to start an exam. 3.9.2 Ending an Exam To end an exam, choose “End Exam” on the Gallery screen or close the App.
Vave Personal Ultrasound • U S E R M A N UA L 3.10 Managing Patient Information 3.10.1 Entering Patient Information Make sure the probe is connected to your mobile device. On the scan tab, choose “Start New Exam” and enter detailed patient information manually. Information is saved once you move to the next page. • On the saved exam page, go to the “Patient info” section to enter or change patient information. ! Please make sure that you entered the correct patient information.
Vave Personal Ultrasound • U S E R M A N UA L 3.11 Imaging Typical use of the Vave Probe is five continuous scanning minutes followed by 10 minutes in standby mode (or turned off). 3.11.1 Imaging Mode: B-Mode When you start an exam, the Vave Probe defaults to B-Mode (brightness mode). Sometimes referred to as 2D Mode, this two-dimensional imaging mode displays in grayscale. 3.11.
Vave Personal Ultrasound • U S E R M A N UA L 3.11.4 Capture Bar The capture bar contains additional settings, snap, freeze, and record cine and the gallery icon. Depth • To adjust depth, swipe up or down over the ruler on the left side of the screen. Gain • To manually adjust the gain, swipe left-to-right (increase) or right-to-left (decrease) on the ultrasound image. Focal Depth • To adjust the focal depth press and hold on the ultrasound image.
Vave Personal Ultrasound • U S E R M A N UA L 3.12 Review Findings When you have finished imaging, you can evaluate and edit the exam images and cines. Saved exams • To view your saved exams, tap the saved exams icon. You will see two sections: “Performed Exams” and “Folders”. Each section can have several folders. Tap a folder name to open it. • The Folders section contains a folder named “My Portfolio”. In this folder you can collect ultrasound images.
Vave Personal Ultrasound • U S E R M A N UA L 3.12.2 Manage Images & Cines To select several images/cines: tap the select option and tap the images/cines you want to select. To delete images/cines: select the image(s)/cine(s) and tap the trash icon. To add images/cines to a saved scan folder: 1. Select the image(s)/cine(s) 2. Tap the briefcase icon for a popup list of existing folders 3. Select the folder where you would like to store the documents 4.
Vave Personal Ultrasound • U S E R M A N UA L 3.14.2 System Maintenance You can access the audit logs in profile settings. Tap on the user avatar on the upper-right corner to open profile settings. You can change or view the audit log by tapping the “View Your Activity” button. 3.15 Help 3.15.1 Need Help? If you require additional assistance please contact Vave Health at www.vavehealth.
Vave Personal Ultrasound • U S E R M A N UA L 4.2 Disinfecting Make sure you have cleaned the Vave Probe before beginning disinfection (see previous section, “Cleaning”). Before you begin, determine the level of disinfection by referring to Spaulding Classification section of this manual. » » Different levels of disinfection require different steps, not just different solutions. The Vave Probe is not designed for sterilization and cannot be sterilized before or between uses.
Vave Personal Ultrasound • U S E R M A N UA L 5 Safety This chapter provides instructions on safe usage of the Vave Probe and includes additional safety guidelines. There are two types of safety information in this section: • Warnings: indicate information critical to safe operation • Cautions: highlight potential damage that may void your warranty or service contract, or destroy patient data. 5.
Vave Personal Ultrasound • U S E R M A N UA L “Diagnostic ultrasound is recognized as a safe, effective, and highly flexible imaging modality capable of providing clinically relevant information about most parts of the body in a rapid and cost-effective fashion.” (World Health Organization) 5.2.1 Product Safety Vave Health is responsible for the safety of the Vave Probe. The safety of connected mobile devices is the user’s responsibility. Always read and follow the safety guidelines for your smart device.
Vave Personal Ultrasound • U S E R M A N UA L Cleaners & Disinfectants • Use only cleaners and disinfectants recommended by Vave Health and carefully follow all manufacturer instructions. • Disinfectants are recommended based on their chemical compatibility (not their biological effectiveness) with product materials. For the biological effectiveness of a disinfectant, see the guidelines and recommendations of the disinfectant manufacturer, the U.S. Food and Drug Administration, and the U.S.
Vave Personal Ultrasound • U S E R M A N UA L Bioeffects Thermal Thermal bioeffects refers to the heat created by ultrasound energy. Tissue absorbs ultrasound energy to varying degrees depending on the tissue’s absorption characteristics. The absortion coefficient dictates how body tissue will absorb the ultrasound energy: • Fluids: The absorption coefficient of fluids is very low. Fluids such as amniotic fluid, blood, and urine absorb little ultrasonic energy.
Vave Personal Ultrasound • U S E R M A N UA L Applying ALARA: The appropriate system setting is determined by the specific diagnostic information needed. According to ALARA, ultrasound usage should be limited to the lowest acoustic output for the shortest duration of time. The ultrasound user should consider the type of patient, exam type, patient history, difficulty in retrieving the required information, and the potential of localized heating due to transducer surface temperatures.
Vave Personal Ultrasound • U S E R M A N UA L • Display Standards (TI Display/MI Display) The system output display consists of the following exposure indices to indicate the potential thermal and mechanical effects: • TI: This is continuously displayed over the range of 0.0 to maximum output, based on the application, in increments of 0.1, and consists of the following indices: – thermal index for soft tissue (TIS) – thermal index for bone (TIB) Keep output display indices to a minimum.
Vave Personal Ultrasound • U S E R M A N UA L • Controls Affecting Display Indices Use system controls to change the TI and MI values. B-Mode Controls • Focus: When the focal depth is near the natural focus of the scanner, the MI may be higher. • Zoom: Increasing the zoom magnification by spreading the display may increase frame rate, thereby increasing the TI. The number of focal zones may also increase automatically to improve resolution.
Vave Personal Ultrasound • U S E R M A N UA L • In situ, derated, & water value intensities All intensity parameters are measured in water. Because water absorbs very little acoustic energy, these water measurements represent a worst-case value. Biological tissue does absorb acoustic energy. The true value of the intensity at any point depends on the amount and type of tissue and the frequency of the ultrasound that passes through the tissue.
Vave Personal Ultrasound • U S E R M A N UA L • Conclusions regarding tissue models & equipment survey Tissue models are necessary to estimate attenuation and acoustic exposure levels in situ from measurements of acoustic output made in water. Model accuracy may be limited due to varied tissue paths during diagnostic ultrasound exposures and soft tissue irregularities. No single tissue model can predict exposures in all situations. A homogeneous tissue model with an attenuation coefficient of 0.
Vave Personal Ultrasound • U S E R M A N UA L 5.2.7 Fire & Electrical Safety Fire Safety Always have fire extinguishers available for both electrical and non-electrical fires. In the event of an electrical or chemical fire, use only extinguishers that are specifically labeled for such purposes. Using water or other liquids may cause fatal or other serious personal injury. To help prevent electrical fires, only use electrical products in an environment for which they were designed.
Vave Personal Ultrasound • U S E R M A N UA L Electromagnetic Interference The way an electromagnetic interference (EMI) from other equipment affects the Vave Personal Ultrasound depends on the system’s operation mode, image control settings, and the type and level of electromagnetic phenomena. Electromagnetic phenomena may be intermittent, making it difficult to identify the source. If you experience EMI, use caution if you continue using the system, or consider relocating your system.
Vave Personal Ultrasound • U S E R M A N UA L Recommended Separation Distances by Transmitter Frequency Rated Maximum Output Power of Transmitter (Watts) 150kHz to 80 MHz 80 to 800 MHz 800 MHz to 2.5 GHz 0.01 0.35 m (13.8 in) 0.12 m (4.7 in) 0.23 m (9.1 in) 0.1 1.1 m (3.6 ft) 0.38 m (15 in) 0.73 m (28.7 in) 1 3.5 m (11.5 ft) 1.2 m (3.9 ft) 2.3 m (7.5 ft) 10 11 m (36.1 ft) 3.8 m (12.5 ft) 7.3 m (24 ft) 100 35 m (114.8 ft) 12 m (39.4 ft) 23 m (75.
Vave Personal Ultrasound • U S E R M A N UA L 6 References 6.1 Compliance Statement The Vave Personal Ultrasound system complies with national standards and laws. Users are responsible for ensuring that the chosen mobile device and probe are compliant with the law in the jurisdiction where the product is used. Vave Health meets all regulatory standards listed in this chapter. 6.2 The Vave Probe Personal Ultrasound System 6.2.
Vave Personal Ultrasound • U S E R M A N UA L 6.2.
Vave Personal Ultrasound • U S E R M A N UA L If the probe has been in an environment below 0°C (32°F), allow to reach operating temperature before turning on or operating — approximately 20 minutes depending on length of temperature exposure. Condensation inside the devices could cause damage. 6.3 Standards 6.3.1 Biocompatibility ANSI/ISO 10993-1:2009 — Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. 6.3.
Vave Personal Ultrasound • U S E R M A N UA L Risk, Product Specification, Design Review, & Verification/Validation 21 CFR 11 2014 Electronic Records and Electronic Signatures 21 CFR 801 2014 Labeling 21 CFR 820 2014 Quality System Regulation 21 CFR 821 Medical Device Tracking Requirements 21 CFR 822 Post Market Surveillance 21 CFR 830 Unique Device Identifier IEC 62304 Medical Device software — software lifecycle processes IEC 62366 Medical Devices-Application of usability engineering to medical devices I
Vave Personal Ultrasound • U S E R M A N UA L 6.4 Wireless Compliance with FCC and ISEDC This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Vave Personal Ultrasound • U S E R M A N UA L 6.5 Acoustic Output Tables TIS Index label MI Maximum Index value 1.39 Associated Pr3 (MPa) acoustic parameter W0 (mW) 2.30 Scan TIB Non-scan Non-Scan Apart<1cm2 Apart>1cm2 0.978 - - 185 - min of [W .3 (Z1)1 ITA, (Z1)] (mW) 3 - Z1 (CM) - Zsp - Zsp 4.53 2.76 x (cm) Y (cm) PD 0.830 PRF 2000 pr @ PII max 3.55 (a) - - - (a) 1.8 - - - (a) 1.2 - - - (a)* FLx (cm) 10.0 - - FIy (cm) 7.
Vave Personal Ultrasound • U S E R M A N UA L 6.6 Control Effects Guidance Documents For more information about ultrasonic bioeffects and related topics, see the following: • “Bioeffects and Safety of Diagnostic Ultrasound.” AIUM Report, January 28, 1993. • “American Institute of Ultrasound in Medicine Bioeffects Consensus Report.” Journal of Ultrasound in Medicine, Volume 27, Issue 4, April 2008. • Third Edition of the AIUM Medical Ultrasound Safety brochure, 2014.
Vave Personal Ultrasound • U S E R M A N UA L 6.8 Glossary Of Terms 6.8.1 Acoustic Outputs For ultrasound terms not included in this glossary, refer to Recommended Ultrasound Terminology, Third Edition, published by AIUM. • Aaprt Area of the active aperture measured in cm2. • deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to [(4/π)(Wo/ITA(z))]0.5, where ITA(z) is the temporal-average intensity as a function of z in centimeters.
Vave Personal Ultrasound • U S E R M A N UA L 6.8.2 Acoustic Artifacts Image artifacts are common in clinical sonography (ultrasound) and may be a source of confusion. Some artifacts may be avoidable, caused by improper scanning techniques. Other artifacts are generated by physical limitations. Ultrasound artifacts can be understood by considering the physical properties of the ultrasound beam, the propagation of sound in matter, and assumptions of image processing.
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