Intended Use, Concept Of Operation; Short Description; Who Can Operate The Device - Innomed Medical HS112 C-1 User Manual

12-channel ecg device with 112 mm wide built-in printer, colour touch screen lcd display
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2. Intended use, concept of operation

2.1. Short description

The HS112C-1 is a battery and mains operated, microprocessor controlled, modern, 12-
channel electrocardiograph used to measure and graphically record the heart's bioelectric
potential during cardiovascular system examinations in humans. The device is equipped
with a 12-channel amplifier and an ECG signal-processing unit. All 12 channels can be
displayed simultaneously on the large colour display. The fast, built-in recorder is suitable for
6 or 12 channel recording. The 12-channel landscape printing mode makes this device
competitive with those equipped with an A4 printer.
High-speed online data transfer through a USB cable or an optional radio connection (WiFi)
makes it possible to display the 12 channels online on a PC or to print them out.
The device is easy to use. Access to the main functions, preset recording mode selection, and
record creation and storing can be achieved by pressing only a few buttons.
Based on the recording, the HS112 C-1 can perform an ECG analysis, suggest a diagnosis,
and carry out heart rhythm analysis.
Even in its default configuration, the device can be connected to a computer. This makes it
possible to display the 12 channels online, and store records on a big-screen PC.
Record identification in the HS112 C-1 is done using not only a time and date stamp, but also
through the assignment of an automatically generated identification code, or through a patient
identification code and patient name entered by the user.
The archiving task is performed by a PC-based cardiological database management system
(Innobase) running under Windows. This system can be used for ECG monitoring, as well as
ECG and diagnosis storage, search, and display. It can also receive signals and archive
records from other ECG devices manufactured by Innomed Medical.

2.2. Who can operate the device?

The HS112 C-1 ECG device can be operated by qualified hospital or clinic personnel. The
operation of the device is simple and easy to learn. The labels and symbols on the buttons are
designed to help with device operation, which is also simplified by the possibility of
touchscreen interaction.
Innomed Medical does not organize any courses concerning device operation. Device training
is performed within the scope of medical training.
Caution!
The device will suggest a suitable diagnosis. However, the fact that this is merely a
suggestion must be taken into consideration at all times. The final decision is always the
responsibility of the physician. Innomed Medical will not assume liability for any damage
incurring from potential misdiagnosis by the device!
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HS112 C-1 User Manual
R-6730-EN02-E

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Heartscreen112 clinic

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