Aircraft Use; Operator Profile - ZOLL LifeVest 4000 Patient Manual

LifeVest 4000 Patient Manual

Aircraft use

The LifeVest 4000 was tested to demonstrate compliance to the emissions and
immunity requirements of the following standard: RTCA DO-160G,
Environmental Conditions and Test Procedures for Airborne Equipment, Section
20 (RF immunity) and Section 21 (RF emissions).
Check with your airline for any special restrictions on using personal electronic
equipment when making your flight reservations.

Operator profile

As defined by IEC 60601-1-6, the operator profile is a summary of the mental,
physical, and demographic traits of the intended user population.
According to the IEC definition, the operator is defined as the person interacting
with the device. In the case of the LifeVest, there are three operators:
 The patient wears and interacts with the LifeVest on a daily basis. The patient
profile appears below.
 ZOLL authorized representatives fit patients with the equipment, and train
patients. The ZOLL authorized representative profile appears below.
 Healthcare professionals prescribe the LifeVest for the patient. The
healthcare professional profile appears below.
Patient profile
The device is appropriate for patients who are at risk for sudden cardiac arrest
and meet the requirements described in the Patient Manual. The patient wears
the LifeVest at all times (except when showering or bathing), changes and
charges the batteries every 24 hours, responds to alarms, and presses the
response buttons if there is a treatment alarm in order to prevent inappropriate
shocks from occurring.
While a patient is using the device, the patient is expected to do minimal
maintenance, including periodically cleaning and inspecting the system, as
instructed in section 3, page 3-31.
The patient is not expected to do any service on the device. Only ZOLL is to
perform service on the device. The device is to be returned to ZOLL for service.
ZOLL authorized representative profile
ZOLL authorized representatives are ZOLL-trained professionals. Their job is to
program the equipment according to the patient's prescription, measure and fit
patients with the LifeVest equipment, train patients and family members, and
provide follow-up assistance if necessary.
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