Verathon AORTASCAN AMI 9700, Руководство по эксплуатации и техническому обслуживанию

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Operations & Maintenance Manual: Important Information
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 system is not user adjustable and is limited to the minimum
level necessary for effective performance. Data on acoustic output levels can be found in the
Product
Specifications section of this manual.
CONTRAINDICATIONS
The AortaScan AMI 9700 is not intended for fetal use or for use on pregnant patients.
The AortaScan AMI 9700 is not intended for acute events such as aortic dissection, ulcer, or rupture.
PRECAUTIONS & 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
The AortaScan AMI 9700 and related devices may contain mineral oils, batteries, and other
environmentally hazardous materials. When the instrument and/or accessories have reached the
end of their useful service life, see the section
Device Disposal on page 63.
CAUTION
When using the AortaScan AMI 9700 with optional ScanPoint
®
software, your computer must
be minimally certified to EN / IEC / CSA / UL 60950 or 60101‑1 standards. This configuration
ensures that compliance to the EN/IEC 60601‑1‑1 system standard is maintained. Anyone
connecting additional equipment to the AortaScan AMI 9700 signal input port or signal
output port configures a medical system, and is therefore responsible for ensuring that the
system complies with EN/IEC 60601‑1‑1. If you need assistance, contact your biomedical staff,
Verathon
®
representative, or Verathon Customer Care.
CAUTION