Introduction
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SEER™ 1000
2067634-077 Revision B
Intended User
The devices are intended to be used by trained operators under the direct
supervision of a licensed healthcare practitioner in a hospital or medical
professional’s facility.
Indications for Use
The SEER 1000 is a Holter recorder which is indicated for patients who
may benefit from a long-term continuous electrocardiographic (ECG) re-
cording, including, but not limited to, those with complaints of palpita-
tions, syncope, chest pain, shortness of breath, or those that need to be
monitored to judge their current cardiac functionality.
Intended Use
The SEER 1000 digital Holter recorder is intended to continuously record
ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-
tended to be used with an ECG analysis software package. The recorded
data are downloaded to a PC for analysis and subsequent evaluation by a
trained physician or healthcare professional.
Contraindications
There are no known contraindications to using these devices.
Prescription Device Statement
CAUTION
United States federal law restricts this device to sale by, or on the or-
der of, a physician.
Regulatory and Safety Information
This section provides information about the safe use and regulatory com-
pliance of this system. Familiarize yourself with this information, and read
and understand all instructions before attempting to use this system. The
system software is considered medical software. As such, it was designed
and manufactured to the appropriate medical regulations and controls.
