Introduction; Intended User; Indications For Use; Prescription Device Statement - GE T2100-ST1 Operator's Manual

Introduction

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This document describes the T2100-ST1 and T2100-ST2 treadmills
also referred to as the "system", "device", or "product". The
document is intended to be used by clinical professionals.
This chapter provides general information required for the proper
use of the system and this manual. Familiarize yourself with this
information before using the system.

Intended User

This manual is geared for clinical professionals. Clinical
professionals are expected to have working knowledge of medical
procedures, practices, and terminology as required for completing
these examinations.

Indications for Use

The T2100-ST1 and T2100-ST2 treadmills are designed for cardiac
stress testing.

Prescription Device Statement

CAUTION:

Regulatory and Safety Information

This section provides information about the safe use and regulatory
compliance of this system. Familiarize yourself with this
information, and read and understand all instructions before
attempting to use this system. The system was designed and
manufactured to the appropriate medical regulations and controls.
2097937-001 Rev E
12 June 2017
United States federal law restricts this device to sale by, or on
the order of, a physician.
T2100-ST1 Treadmill, 110V / T2100-ST2 Treadmill, 220V
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