Classification Of Medical Device - GE MAC 5 A4 Operator's Manual

Regulatory and Safety Information
NOTICE:
DATA LOSS - Formatting the device's internal flash drive erases all the data in
memory and returns the device to its factory settings.
If possible, back up or record any data that you do not want to lose before
formatting the device's internal flash drive.
WARNING:
ELECTRIC SHOCK HAZARD - The conductive parts of electrodes and associated
connectors for leadwire, including the neutral electrode, should not contact any
other conductive parts including earth.
WARNING:
ELECTRIC SHOCK HAZARD - Devices which connected to the same Ethernet/LAN
with MAC 5 should comply with IEC 60950/IEC60601 or equivalent safety standard.
CAUTION:
DISPOSAL HAZARD - At the end of its service life, the product described in this
manual, as well as its accessories, must be disposed of in compliance with local,
state, or federal guidelines regulating the disposal of such products.
If you have questions concerning disposal of the product, please contact GE or its
representatives.
CAUTION:
INTERCONNECTED DEVICES - When several items of medical equipment are
interconnected, summation of leakage current must meet the leakage current as
per IEC 60601-1.
Connect the device only to the GE approved supplies and accessories.
CAUTION:
ISOLATION FROM SUPPLY MAINS - Do not position the device so that it is difficult to
operate the disconnection of the AC power supply of the device.

Classification of Medical Device

The device is classified as follows according to IEC 60601-1.
Table 129: Medical Device Classifications
Category
Type of protection against electrical shock
Degree of protection against electrical shock
Degree of protection against harmful ingress of
solids and liquids
344 MAC ™ 5 A4/MAC ™ 5 A5/MAC
Classification
Class I, internally powered
Type CF defibrillation-proof applied part
The Ingress Protection (IP) code for this device is
IP 20.
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