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Manual Spaulding 2100iQ ECG Device

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Manual

Spaulding Electrocardiograph Model 2100iQ User Manual

System Overview

System Description

The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution.

(Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device

collects and

uploads a dedicated patient’s ECG (electrocardiograph) information to the WebECG system and receives a report back from

the WebECG system.

The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythms data to iOS®, Android™ or Windows® devices using

Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the

Spaulding Application software (Spaulding ECG) to collect a 12-lead ECG.

The Spaulding ECG application then communicates to the Spaulding webECG server to upload ECG data through an Internet

connection.

The complete Spaulding Electrocardiograph 2100iQ Kit includes:

■

Spaulding Electrocardiograph 2100iQ device

■

Spaulding 12-lead ECG Patient Cable

■

USB Cable

■

User Manual

The Web ECG system allows users to utilize Internet-based applications that manage the ECG data:

■

3rd party tools and algorithms to analyze acquired data

■

Generate diagnostic reports

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Remote access to the stored diagnostic ECGs, webECG reports and Full Disclosure data

■

Site management tools to customize the system user interface (UI)

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Automated notifications to the care team and remote diagnostics

Intended Use

The Spaulding Electrocardiograph 2100iQ is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent

upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the

orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.

The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended

for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive

environments, or as a vital signs physiological monitor.

The Spaulding Electrocardiograph provides uninterpreted 12-lead ECG data and is not to be a sole means of diagnosis.

Throughout this document, the Spaulding Electrocardiograph Model 2100iQ ECG Device will be referred to as the ECG device.

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