Important Information About Your ASSURE System
Indications for Use: The ASSURE system is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.
Contraindications: The ASSURE system is contraindicated for use on patients with an active implantable defibrillator.
Intended Use: The ASSURE system is intended for patients who have been prescribed this device by their physician.
Warnings:
Do not place the Monitor, Therapy Cable, Charger, or Battery in water or other liquids. Avoid spilling any liquids on these devices. Exposure to liquids may cause devices to malfunction or fail. Follow the instructions provided with the devices to properly clean these devices.
If you will be away from home for longer than 24 hours, take the spare, fully charged Battery and Charger with you.
During use, do not stack or place the ASSURE system near other electronic equipment. Doing so may cause the system to malfunction or fail due to electromagnetic interference exposure from the other equipment. If such use is necessary, the ASSURE system and the other equipment should be observed to verify that they are operating normally.
Only use portable radio frequency (RF) communications equipment that is included with or intended for use with the ASSURE system. Do not use any other portable RF communications equipment (including antenna cables and external antennas) any closer than 12 inches (30 cm) to any part of the system. Otherwise, equipment performance may suffer.
When washing the Garment, do not use chlorine bleach, bleach alternatives, fabric softeners, or anti-static sprays. In addition, do not use detergents or detergent “pods” that include bleach or fabric softener additives.
Do not connect line voltages, power banks, or other devices that may attempt to use the USB port on the Charger as an input port. The Charger’s USB port is a dedicated charging port that is Output Only and must be used solely to charge connected devices. Always remove the Therapy Cable before washing the Garment.
If the Plug is removed from the Monitor and then reinserted while the ASSURE system is operational, the system may issue the Connect Plug to Monitor alert repeatedly. This alert will continue to play even if the Plug is removed and re-inserted into the Monitor. If this occurs, remove the Battery from the Monitor, and then re-insert it to restart the ASSURE system.
