CLARIUS HD3 - Device Description

Clarius Scanner HD3 Device Description
revision 9 7
• Users are responsible for image quality and diagnosis.
• This product has demonstrated EMC compliance under conditions that included the use of
compliant peripheral devices. It is important that you use compliant peripheral 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 should be trained medical professionals (e.g., doctors, nurses, technicians) with previous
training in ultrasound. Images produced by the scanner are transmitted wirelessly to the user’s
smart device (tablet or smart phone).
Device Description
For regulatory information in e-labeling format, open the Clarius App and go to the About
page.
The Clarius Ultrasound Scanner is a portable, general-purpose, software-controlled, diagnostic
ultrasound system used to acquire and display high-resolution, real-time ultrasound data
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 that
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 is supplied 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 where
healthcare is provided by trained healthcare professionals. The EC7 HD3
1
and the Clarius
Charger HD3
1
should be used in a stationary setting.
1. Not intended for EMS environment.