User's Manual

Vave Personal Ultrasound • USER MANUAL
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CONFIDENTIAL & PROPRIETARY. CAUTION — Investigational device. Limited by Federal law to investigational use. Not commercially available in the US.
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.
Apply, observe, and enforce appropriate fire regulations for the type of medical area being used.
Electrical Safety
To reduce electrical shock hazards, inspect the scanner face and housing before use. Discontinue use if the housing
is damaged, or if the face is cracked, chipped, or torn.
All patient-contact scanners not specifically indicated as defibrillation-proof must be removed from the patient
before applying high-voltage defibrillation pulse.
High-frequency electrical signals from an ultrasound can interfere with pacemaker operation. Be alert to this
potential hazard and stop using the system if you notice it is interfering with a pacemaker.
• Connecting accessories that have not been approved by Vave could result in electrical shock.
Electrosurgical units (ESUs) and other scanners intentionally introduce RF electromagnetic fields (currents) into
patients. Because imaging ultrasound frequencies are within the RF range, ultrasound scanner circuits are
susceptible to RF interference.
A burn hazard may result from a surgical equipment with a defect in the high-frequency surgical neutral electrode
connection. Do not use scanners with high-frequency surgical equipment.
• Using accessories other than those specified for use with the Vave Probe may result in increased emissions.
5.2.8 Electromagnetic Safety
The Vave Personal Ultrasound uses wireless technology to communicate with your smart device. Wireless
communication can be aected by severe weather conditions and radio frequency interference. Such environments
will not cause the safety of the Vave Personal Ultrasound to deteriorate, but the captured image may show signs of
unwanted noise and/or artifacts. The technology used in the Vave Personal Ultrasound is designed to minimize these
aects but may not eliminate them entirely.
Electromagnetic Compatibility
The Vave Probe has been manufactured with existing electromagnetic compatibility requirements and complies with
electromagnetic compatibility standards to provide reasonable protection against harmful interference in a typical
medical installation.
Use of this system in the presence of an electromagnetic field can cause degraded image quality. If this occurs
frequently, review the environment surrounding the system and identify possible sources of radiated emissions.
Electrostatic Discharge Precautions
Electrostatic discharge (ESD), or static shock, results from the flow of an electrical charge from a person or object
of a higher charge to that of a lower charge. ESD is most prevalent in low-humidity environments, often caused by
heating or air-conditioning.
To reduce ESD:
Use anti-static spray on carpets, linoleum, and mats. Or use a ground wire connection between the system and the
patient table or bed.
• Do not touch the connector pins on the battery.
Electromagnetic Emissions
Ensure that the Vave Personal Ultrasound is used only in those operating environments indicated in the
following table. Operating the system in an environment that does not meet these conditions may degrade
system performance.