ZOLL LifeVest 4000, Patient Manual, Page: 11 / 144

Introduction
Page 1-5
CAUTIONS
Any medical electrical equipment connected to the patient at the same
time as the LifeVest must be defibrillator proof, as shown by this symbol. If the
equipment is not defibrillator proof, the equipment may be damaged if the
LifeVest delivers a treatment shock. Disconnect any non-defibrillator proof
equipment from the patient while the patient is wearing the LifeVest.
Environment considerations related to noise and vibration
Certain environments or situations you encounter that are loud and have high
vibration could affect the LifeVest. A loud environment could make it difficult for
you to hear an alert to be able to appropriately respond. A high vibration
environment may result in an inappropriate treatment. For example, riding a
motorcycle may cause vibration and make it difficult for some patients to hear an
alert which may result in an inappropriate treatment.
If you encounter a loud, high vibration environment while wearing the LifeVest,
you should be attentive to your device to ensure you respond to any alerts. In the
unlikely event that vibration causes you to receive a siren alert, hold the
response buttons to prevent receiving a treatment and move away from the
source of vibration.
Known residual risks
A rash or skin irritation is a potential risk with LifeVest use. If you experience skin
irritation, which may include redness, itching or swelling and you believe that
medical attention is required, consult your health care provider.
A treatment shock from any defibrillator may cause skin burn. The LifeVest uses
Blue™ gel to reduce the chance of burn.
Intended use locations
The intended electromagnetic environments for the LifeVest 4000 are home,
small clinic, hospital, and transport.
Essential performance
The essential performance of the LifeVest is that it detects ventricular fibrillation
or ventricular tachycardia, then delivers a defibrillating shock. Unacceptable risks
include loss of detection and treatment functionality.