Safety Electrical Safety
24 Lumify Ultrasound System
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
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” on
page 157 section.) For maximum safety, observe these warnings and cautions:
WARNING
Devices that are compliant with IEC 60950-1 have not been evaluated for compliance with
the IEC 60601-1 temperature limits for patient contact. Therefore, only the operator is
allowed to handle the device.
WARNING
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.
WARNING
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.
WARNING
All patient-contact devices, such as transducers, pencil probes, and ECG leads not specifically
indicated as defibrillation-proof, must be removed from patient contact before application
of a high-voltage defibrillation pulse. See “Defibrillators” on page 27.
To Next Page
Loading...