EchoNous Bladder & Vein User Guide 3
Intended uses
The System enables the user to perform Vascular Access procedures when connected to an EchoNous Vein
probe.
Images are able to be annotated by using voice or text. Examination notes can be entered.
The System provides optional wireless connectivity allowing remote storage and device tracking.
Accessories for wireless printing, barcode scanning, and the EchoNous AI Station are supported and available in
some countries.
FIGURE 1. System user interface and display
Intended uses
The EchoNous System is for noninvasive imaging of the human body and is intended for the following
applications: Abdominal, Musculoskeletal, Pediatric, Small Organ, and Peripheral vessel. Users must have
ultrasound training for abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging.
The System can also be used to obtain an image of the bladder that is used to automatically determine bladder
volume.
Contraindications
• The System is designed for transcutaneous scanning only. Do not attempt intracavitary imaging; in particular,
trans-esophageal, trans-vaginal and trans-rectal scans are contraindicated.
• The System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
• Show care when scanning near a wound to avoid damaging or
further injuring the affected area.
• Review the ultrasound image when measuring bladder volume on
pregnant or postpartum patients, and adjust the bladder outline if it
has included amniotic fluid or the uterus in the measurement.
Federal (USA) law restricts this device to sale by or on the order of a
physician.
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