Important Information About the 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:
The ASSURE system is not intended for use on patients with an implantable pacemaker that produces a pacemaker pulse artifact greater than 0.5 mV on any ASSURE system ECG channel. This artifact may interfere with the system’s ability to detect dangerous heart rhythms and prevent shock delivery.
Operating a motorcycle, boat, riding lawnmower, or other noisy vehicle, or any vehicle or equipment that emits heavy vibrations while wearing the ASSURE system may prevent the patient from realizing an alert is happening.
Keep the ASSURE system, Charger, and all accessories away from open flame, flammable gases, or other potential fire sources. Shock delivery in these environments may pose an explosion or fire hazard risk.
The ASSURE system is magnetic resonance (MR) unsafe. Do not wear or use this device near MR imaging equipment.
Do not place the Monitor, Therapy Cable, Charger, or Battery in water or other liquids. Avoid spilling any liquids on these devices. Liquids entering these devices may cause them to malfunction or fail.
Do not alter, drop, or abuse any part of the ASSURE system. Attempting to alter the equipment in any way may cause the device to malfunction or fail. Do not take apart the Monitor. Dangerous high voltages may be present. If service is required, call the ASSURE Helpline at (833) 692-7787 (toll free).
During use, do not stack or place the ASSURE system near other equipment. Doing so may cause the system to malfunction or fail due to EMI 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 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.
