Fusion MCT Wireless Recorder
3
Overview
The Fusion MCT Wireless recorder is a battery operated, solid state
recorder designed to record symptomatic as well as asymptomatic heart
arrhythmias.
The Fusion recorder provides up to 30 days of total recording time for 2
channels. The Fusion recorder is enhanced with Arrhythmia Detection
firmware which will capture and automatically record asymptomatic,
infrequent, or elusive heart arrhythmia events such as Bradycardia,
Tachycardia, Pause, and Atrial Fibrillation.
Once an event is recorded, the event ECG is automatically transferred
via a digital cellular link. If a digital cellular link is not available, the
event ECG can be transferred by Bluetooth to a phone line via a Home
Link Bluetooth modem.
Precautions
A.
Patient leads must be removed from electrodes before defibrillation.
B.
Observe local laws for disposal of batteries.
C.
Do not leave the batteries in the recorder when it is not in use.
Damage from corrosion could result.
D.
Patient should be instructed to avoid close proximity to heavy
electrical equipment or other sources of electromagnetic
interference.
E.
Use only the provided battery pack. Observe polarity when
inserting.
F.
Recorder is not for infant use.
G.
No automatic analysis algorithm can replace data review by a
qualified physician. Review and confirmation of analysis results is
required.
H.
Patients should seek immediate medical attention if they experience
symptoms that concern them.
Fusion MCT Wireless Recorder
4
Disclaimer
Operation of the Fusion recorder may be subject to governmental and
business restrictions, including but not limited to air travel and hospital
visitations.
This device is approved for use only in the United States of America.
Additional equipment classification information as required in EN 60601-1
A.
EQUIPMENT not suitable for use in the presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR
WITH OXYGEN OR NITROUS OXIDE
B.
IPX0 Ordinary Equipment (enclosed equipment without protection
against ingress of water)
C.
Internally Powered Equipment
D.
Mode of Operation - Continuous Operation
