BLADDERSCAN BVI 6100 - SAFETY INFORMATION; Ultrasound Energy Safety; Contraindications; Cautions & Warnings

2
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, please refer to the American Institute of Ultrasound in Medicine publication,
Medical Ultrasound Safety.
The ultrasound output power of the BladderScan BVI6100 instrument is not user adjustable and is limited to
the minimum level necessary for effective performance. For more information about acoustic output levels,
see the Product Specifications chapter on page32.
CONTRAINDICATIONS
The BladderScan BVI 6100 is not intended for fetal use or for use on pregnant patients, patients with open
skin or wounds in the suprapubic region, or patients with ascites.
CAUTIONS & WARNINGS
Warnings indicate that injury, death, or other serious adverse reactions may result from use or misuse of
the device. Cautions indicate that use or misuse of the device 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. Please heed the following warnings and cautions.
PRECAUTIONS
When using the system with optional ScanPoint
®
software, your computer must be minimally
certified to EN/IEC/CSA/UL 60950‑1 or 60101‑1 standards. This configuration ensures that
compliance to the EN/IEC60601‑1 system standard is maintained. Anyone connecting additional
equipment to the signal input port or signal output port configures a medical system, and is
therefore responsible for ensuring that the system complies with EN/IEC60601‑1. If you need
assistance, contact your biomedical staff, local representative, or Verathon
®
Customer Care.
CAUTION
Use of the following cleaning methods or solutions may cause device damage not covered by
the BladderScan BVI 6100 warranty:
• Do not immerse the instrument in disinfectant solution.
• Do not use Cidex Plus
®
to disinfect the instrument. Cidex Plus will damage the plastic enclosure.
• Do not subject the instrument to any method of sterilization.
CAUTION