User's Manual

Clarius Ultrasound Scanner - HD3 Scanners Device Description
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devices to reduce the possibility of causing interference to radios, televisions, and other
electronic devices.
• Circumstances in the patient’s environment may negatively impact the scanner and the
exam. For example: (1) Chemicals and gases in the operating room. (2) Altitudes below
-382 m or above 4000 m.
• Vulnerable patients, such as children and pregnant/nursing women, may be more prone to
the exposure of acoustic energy when the scanner is used for prolonged periods.
• Biological incompatibility may exist between the scanner materials used and the biological
tissues, cells, and body fluids of the patient/user, taking account of the intended purpose
of the scanner.
• Using the scanner in the patient environment may be unsafe if the following conditions
exist: (1) Extremes in humidity (RH<15% and RH>95%). (2) Ambient temperatures that are
excessively high (>40°C / 104°F) or excessively low (<-20°C / -4°F).
• Unqualified/untrained personnel purchasing and using the Clarius Scanner HD3 may be
unable to attain quality images.
• Each Clarius Scanner HD3 contains a Li-ion battery. Treat the battery with precaution.
Users will be trained medical professionals (e.g., doctors, nurses, technicians) with previous
training in ultrasound. Images produced by the scanner are transmitted wirelessly to your
smart device (tablet or smart phone).
Device Description
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic
ultrasound system used to acquire and display high-resolution, real-time ultrasound dat a
through a commercial off-the-shelf (COTS) Apple iOS or Android™ device. The Clarius
Ultrasound Scanner series of wireless scanners are Bluetooth and Wi-Fi-based scanners tha t
communicate with a traditional tablet/smartphone via direct Wi-Fi to allow users to export
ultrasound images and display in different modes of operation. The Clarius Scanner HD3
houses a battery and internal power supplies, multichannel beamformer, prescan converter,
and Wi-Fi components. The Clarius Scanner HD3 comes with a charger.
The system is a transportable ultrasound system intended for use in rotary-wing air
ambulances, road ambulances, and emergency medical service (EMS) environments wher e
healthcare is provided by trained healthcare professionals. The EC7 HD3
1
and the Charger
1
should be used in a stationary setting.
Regulatory information is provided using the e-labelling format and is available in the Clarius
App "About" page.
1. Not intended for EMS environment.