Introduction
Safety Messages
WARNING:
PATIENT SAFETY/EQUIPMENT FAILURE — Using unauthorized supplies or
accessories can result in patient injury or equipment failure.
To ensure patient safety, use only supplies and accessories manufactured or
validated by GE Healthcare and recommended for use with this device.
Parts, supplies, and accessories must meet the requirements of the applicable
safety standards. The system configuration must meet the requirements of the
IEC60601/EN60601-1 Medical Electrical Systems standard. Using accessory
equipment that does not comply with the equivalent safety requirements of this
equipment may lead to a reduced level of safety of the resulting system.
When choosing accessories, consider the following:
• Use of the accessory in the patient vicinity.
Patient vicinity is defined as a space, within a location intended for the examination
and treatment of patients, extending 1.83m (6 ft.) beyond the normal location of
the bed, chair, table, treadmill, or other device(s) supporting the patient during
examination and treatment, and extending vertically to 2.5m (8 ft., 2.4 in.) above
the floor.
• Evidence that the safety certification of the accessory was performed in accordance
with the appropriate IEC60601/EN60601-1 standard(s).
Contact GE Healthcare for information before connecting the device to any
accessories that are not recommended in this manual.
2053535-004D
MAC™2000 ECG Analysis System
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