CARDIAC STIMULATOR
ENGLISH Page 1 of 49
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INTRODUCTION & ESSENTIAL PRESCRIBING
INFORMATION
1.1 Device Description
1.1.1 Description of Stimulator
Micropace cardiac stimulator systems are all based on the EPS320 cardiac stimulator, a diagnostic
external programmable cardiac stimulator.
The description of each system is described in its own section below.
1.1.2 Accompanying Documentation
User Instruction Manual (Instructions for Use), this document.
Technical Description, which includes installation instructions and advanced usage information
(English-only, included in full English UIM MP3395).
Accessories Unit Contents and Instructions for Use Leaflet
Service Manual is available on request
It is strongly recommended that the Operator reads the User Instruction Manual document in
its entirety and is familiar with its contents before using the Stimulator on patients.
1.1.3 Intended Use
The Micropace Cardiac Stimulator is intended to be used for diagnostic electrical stimulation of the
heart for the purpose of initiation and termination of tachyarrhythmias, refractory measurements and
measurements of electrical conduction.
1.1.4 Indications for Use
The Stimulator system is an electrical stimulus generator for diagnostic cardiac stimulation during
electrophysiological testing of the human heart.
1.1.5 Operating Environment
The stimulator is intended for use in air conditioned hospital cardiac electrophysiology laboratories
equipped for advanced cardiac resuscitation, by technicians trained in diagnostic cardiac stimulation
under constant supervision by a cardiologist. Stimulator parts Remote Station MP3168 and connection
boxes MP3086 and MP3014 may be used in the patient environment, but must be protected from
ingress of fluids. The required installation and electromagnetic environment is described in the
Technical Manual.
Device is not intended for use with flammable gasses of liquids, no part of it is sterile or sterilizable
and device is not protected from ingress of fluids.
Warning: Do not stack EPS320 components or use them directly adjacent with other equipment. If
adjacent or stacked use is necessary, verify normal operation in the configuration per the system
verification instructions in this IFU.
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