Medical Device Classification - GE SEER 1000 Operating Manual

Ecg recorder and mobile application

Table of Contents

Introduction

NOTICE

ADVERSE ENVIRONMENTAL IMPACT – Electrical devices and accessories

contain metal and plastic parts that have to be disposed of properly.

Dispose of the device and its accessories in accordance with applica-

ble local and national waste regulations after the product's lifetime

has expired.

If you have questions concerning the disposal of this product, contact

GE Healthcare or a facility authorized by GE Healthcare.

NOTICE

POSSIBLE LOSS OF ECG RECORDING OR POOR SIGNAL QUALITY – The

recorder might be used with insufficient results if the patient does not

have all relevant information.

It is the responsibility of the medical doctor to provide the patient with

the information required for the ECG recording. See "Instructing the

Patient" on page 38 for more information.

NOTICE

INTERFERENCE – Electrical emissions from an electric blanket may de-

grade signal quality.

Do not use in conjunction with an electric blanket.

Medical Device Classification

This device is classified as follows, according to IEC 60601-1:

Medical Device Classification