User's Manual

Vave Personal Ultrasound • USER MANUAL
6
CONFIDENTIAL & PROPRIETARY. CAUTION — Investigational device. Limited by Federal law to investigational use. Not commercially available in the US.
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.
Using the product incorrectly, or for purposes other than intended and expressly stated in this manual may
release Vave or its agents from some or all responsibility for resultant noncompliance, damage, or injury.
In compliance with part 15 of the FCC rules, operation of this device is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Install and operate medical equipment according to electromagnetic compatibility (EMC) guidelines.
This product has demonstrated EMC compliance under conditions that include the use of compliant peripheral
devices. Using portable and mobile radio-frequency (RF) communications equipment can
aect the operation of medical equipment.
Do not operate the system in the presence of flammable gases or anesthetics.
Users are responsible for image quality and diagnosis.
1.1 System Description
The Vave Personal Ultrasound is a wireless, pocket-sized diagnostic ultrasound device consisting of both
hardware and a mobile application (“Vave App”). The purpose of the system is to provide a low-cost, easy
to use and high-quality ultrasound platform for teaching and clinical applications.
The ultrasound probe (“Vave Phased”) uses a state-of-the-art piezoelectric transducer, houses a removeable
lithium ion battery and components required for ultrasound imaging and Wi-Fi connectivity.
The Vave Phased can wirelessly transmit data to a mobile application (“Vave App”), which displays the ultrasound
images and allows certain image parameter modifications through its user interface. The mobile application
runs on non-proprietary commercial display devices capable of supporting wireless connections (iOS or Android
based tablets or phones) so users can view images and control the Vave Probe on a mobile device. Ultrasound
scans can be saved in an examination file on the device and exported for storage or printing.
Vave Probe Vave App
(display device not included)