Verathon BLADDERSCAN BVI 6400, Operation & Maintenance Manual

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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 this device 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 33
CONTRAINDICATIONS
This device 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 60601‑1 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
Failure to follow these instructions may cause device damage not covered by the warranty:
• Do not immerse the device in cleaning or disinfectant solution or other liquids.
• Do not subject any part of the device to steam, ethylene oxide, radiation, or similar methods
of sterilization or autoclaving.
• Do not use metal or abrasive brushes. These may scratch the device, causing permanent damage.
• Do not use CIDEXPLUS
® to disinfect the device. CIDEXPLUS will damage the plastic enclosure.
CAUTION