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Appendix I
Mains Isolation
The Trigno Personal Monitor is provided with a Medical Grade iso-
lated power supply which is compliant with IEC60601 series of har-
monized standards for Medical Devices. However, full compliance
with IEC60601-1 Basic Safety for Medical Devices requires that the
PC operating the software be isolated as well. This stems from the
basic requirement to have all patients electrically isolated from equip-
ment within their reach, and since the PC running the Trigno Soft-
ware during data download and analysis is conceivably within their
reach, it too must be isolated.
Delsys does not supply isolation transformers for Personal Com-
puters and their peripherals.
Delsys recommends model IS1000HG manufactured by Tripp
Lite (www.tripplite.com) for this task. This device is a medial grade
isolation transformer capable of delivering up to 1000 W. A smaller
similar version for 500W is also available (IS500HG).
Similar products compliant with IEC60601-1 are acceptable.