P24
were only briefly exposed to temperatures in excess of 35°C (95°F), then the time
required for to return to operating temperature may be shortened.
If the system or transducers have been in an environment below 0°C (32°F),
allow them to return to operating temperature before initiating the system or
connecting the transducers. As condensation inside the devices could cause
damage, allow the transducers to warm to operating temperature to the
extent possible. If the transducers were only briefly exposed to temperatures
below 0°C (32°F), then the time required for the devices to return to
operating temperature may be reduced.
If the probe reaches it maximum surface temperature, the system will enter idle
mode until it returns to operating temperature.
Electrical Safety
The transducer and software, along with a representative device, have been verified
as compliant with IEC 60601
‑
1. The transducers meet Type BF isolated applied part
requirements. When the transducer and software are used in conjunction with a
device compliant with IEC 60950
‑
1, the system meets IEC 60601
‑
1 requirements for
Class II/internally powered equipment. (The safety standards met by this system are
included in the “Specifications” section.) For maximum safety, observe these
warnings and cautions:
•
Do not operate this system in the presence of flammable gases or
anesthetics. Explosion can result. The system is not compliant in AP/APG
environments as defined by IEC 60601-1.
•
To avoid risk of electrical shock hazards, always inspect the transducer
before use. Check the face, housing, and cable before use. Do not use if the
face is cracked, chipped, or torn; the housing is damaged; or the cable is
abraded.
•
Ultrasound equipment in normal operation, as with other medical
electronic diagnostic equipment, uses high-frequency electrical signals that
can interfere with pacemaker operation. Though the possibility of
interference is slight, be alert to this potential hazard and stop system
operation immediately if you note interference with a pacemaker.
•
When using additional peripheral equipment that is to be interconnected
by functional connection, the combination is considered to be a medical
electrical system. It is your responsibility to comply with IEC 60601
-
1 and
test the system to those requirements. If you have questions, contact your
ASUSrepresentative.
•
Patient-applied parts meet the standard IEC 60601
-
1. Applied voltages
exceeding the standard, although unlikely, may result in electrical shock to
the patient or operator.
•
To avoid risk of electrical shock, do not use any transducer that has been
immersed beyond the specified cleaning or disinfection level.
