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MAC 5000 Resting ECG Analysis System ... - Jaken Medical...

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Introduction: Safety Information<br />

Modulating Effects in Digital <strong>System</strong>s<br />

This device uses digital sampling techniques that may<br />

produce some variation in amplitudes of Q, R, and/or S<br />

waves from one heart beat to the next, which may be<br />

particularly noticeable in pediatric recordings. If this<br />

phenomenon is observed, the clinician should be aware that<br />

the origin of amplitude variations is not entirely<br />

physiologic. For measuring voltages of Q, R, and S waves, it<br />

is advisable to use the QRS complexes with the largest<br />

deflection of the particular waves.<br />

Installation and Connection<br />

If the installation of this equipment, in the USA, will use<br />

240 V rather than 120 V, the source must be a centertapped,<br />

240 V, single-phase circuit.<br />

Contact GE <strong>Medical</strong> <strong>System</strong>s Information Technologies for<br />

information before connecting any devices to this<br />

equipment that are not recommended in this manual.<br />

Parts and Accessories<br />

To ensure patient safety, use only parts and accessories<br />

manufactured or recommended by GE <strong>Medical</strong> <strong>System</strong>s<br />

Information Technologies.<br />

Parts and accessories used must meet the requirements of<br />

the applicable IEC 601 series safety standards, and/or the<br />

system configuration must meet the requirements of the<br />

IEC 60601-1-1 medical electrical systems standard.<br />

The use of ACCESSORY equipment not complying with the<br />

equivalent safety requirements of this equipment may lead<br />

to a reduced level of safety of the resulting system.<br />

Consideration relating to the choice shall include:<br />

n use of the accessory in the PATIENT VICINITY; and<br />

n evidence that the safety certification of the<br />

ACCESSORY has been performed in accordance to the<br />

appropriate IEC 60601-1 and/or IEC 60601-1-1<br />

harmonized national standard.<br />

1-10 <strong>MAC</strong> <strong>5000</strong> <strong>System</strong> — 2000657-033, Revision A

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