Revision D MAC 1200 resting ECG analysis system Compliance-1
2012250-095
Compliance
Compliance
The country of manufacture can be found on the equipment labeling.
The product complies with the requirements of standard EN 60601-1-2
“Electromagnetic Compatibility - Medical Electrical Equipment”.
The safety and effectiveness of this device has been verified against previously
distributed devices. Although all standards applicable to presently marketed devices
may not be appropriate for prior devices (i.e. electromagnetic compatibility
standards), this device will not impair the safe and effective use of those previously
distributed devices. See user’s information.
Exceptions
The MAC 1200 resting ECG analysis system EMC: Immunity Performance
Users should be aware of known RF sources, such as radio or TV stations and
hand-held or mobile two-way radios, and consider them when installing a
medical device or system.
Be aware that adding accessories or components, or modifying the medical
device or system may degrade the EMI performance. Consult with qualified
personnel regarding changes to the system configuration.
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