Hipaa Privacy; Safety Information; Ultrasound Energy Safety; Contraindications - Verathon BladderScan i10 Operation & Maintenance Manual

HIPAA PRIVACY

The Health Insurance Portability and Accountability Act of 1996 ("HIPAA") regulations require our customers
to monitor and limit the ways in which patients' confidential information is accessed, used, stored,
transmitted, and disposed of. Our customers are ultimately responsible for ensuring all electronic health
information contained within the system is protected. In the course of providing services to customers,
Verathon will remove any electronic protected health information from the system, if such information is still
present.

SAFETY INFORMATION

ULTRASOUND ENERGY SAFETY

To date, exposure to pulsed diagnostic ultrasound has not been shown to produce adverse effects. However,
ultrasound should be used prudently, and total patient exposure should be kept as low as reasonably
achievable (ALARA). Following the ALARA principle, ultrasound should only be used by medical professionals
when clinically indicated, using the lowest possible exposure times necessary to obtain clinically useful
information. For more information on ALARA, refer to the American Institute of Ultrasound in Medicine
publication, Medical Ultrasound Safety.
The ultrasound output power of the BladderScan i10 system is not user adjustable and is limited to the
minimum level necessary for effective performance. For more information about acoustic output levels, see
the chapter "Product Specifications"

CONTRAINDICATIONS

The BladderScan i10 system is not intended for fetal use or for use on fetal patients, pregnant patients,
patients with open skin or wounds in the suprapubic region, or patients with ascites.
WARNINGS & CAUTIONS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of the
system. Cautions indicate that use or misuse of the system may cause a problem, such as a malfunction,
failure, or damage to the product. Throughout the manual, pay attention to sections labeled Important, as
these contain reminders or summaries of the following cautions as they apply to a specific component or
use situation. When using the system, heed the following warnings and cautions.
WARNINGS
WARNING
Do not use the system on:
• Fetal patients.
• Pregnant patients.
• Patients with open skin or wounds in the suprapubic region.
• Patients with ascites.
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