EchoNous Bladder - Warnings, Cautions, and Contraindications; Product Description

Important Information
2 EchoNous Bladder & Vein User Guide
Symbols in this user guide
Warnings, cautions and contraindications
• Warnings, cautions and contraindications are included throughout this manual along with the content to
which they apply. In addition all warnings and cautions are listed in the “
Cautions, warnings, and
contraindications” on page 9.
• A contraindication is a specific situation in which the device should not be used because it may be harmful to
the patient.
Version information
This user guide applies to the EchoNous System with software version V5.0
Product description
The EchoNous System consists of a display running EchoNous System software, connected to one or two
ultrasound probes (EchoNous Bladder™ probe and/or EchoNous Vein™ probe) via cables. The System provides
portable ultrasound imaging in either handheld or AI Station scenarios. The System with its two probes has been
designed to support the following clinical applications:
• Noninvasive urological imaging
• General ultrasound imaging
• Vascular access procedures
The System generates and transmits ultrasound energy in the form of pulses in the 2 to 6 MHz range for the
EchoNous Bladder probes and in the 6 to 14 MHz range for the EchoNous Vein probe into a patient, detects the
reflected pulses, and processes the information to generate ultrasound images and measure anatomical
structures.
The EchoNous System display is an off-the-shelf Android tablet approved, pre-configured, and supplied by
EchoNous. The display comes with a power supply. When the display is connected to an ultrasound probe, the
combination is configured as a medical electrical System.
When equipped with the EchoNous Bladder probe, the System enables the user to automatically measure
bladder volume with or without a brightness mode (B-mode) image for guidance (FIGURE 1.
System user
interface and display). The System processes data in real-time, and when the user is not scanning in the correct
location to detect a bladder, the display guides the user to the correct location, reducing measurement errors.
The user can elect to scan organs beside the bladder, including the kidney and prostate, with controls to change
brightness and depth in this mode.
Warning A warning describes precautions to prevent injury or loss of
life.
Caution A caution describes precautions to prevent damage to the
device.
Note A note provides supplemental information.