Safety Notes; Statement Of Intended Use; Safety And Quality Standards - ADInstruments PowerLab Owner's Manual

Chapter 1

Safety Notes

Statement of Intended Use

All products manufactured by ADInstruments are intended for use in teaching and
research applications and environments only. ADInstruments products are NOT
intended to be used as medical devices or in medical environments. That is, no product
supplied by ADInstruments is intended to be used to diagnose, treat or monitor a
subject. Furthermore no product is intended for the prevention, curing or alleviation of
disease, injury or handicap. ADInstruments products are intended to be installed, used
and operated under the supervision of an appropriately qualified life-science researcher.
The typical usage environment is a research or teaching lab or hospital. ADInstruments
equipment is not intended for use in domestic environments.
Where a product meets IEC 60601-1 it is under the principle that:
The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a product:

Safety and Quality Standards

When used with ADInstruments isolated front-ends, PowerLab systems are safe for
connection to subjects. The FE231 Bio Amp, FE232 Dual Bio Amp and FE234/FE238
Quad/Octal Bio Amps front-ends conform to international safety requirements.
Specifically these are IEC60601-1 and its addenda (Safety Standards, page 3) and
various harmonized standards worldwide (CSA601.1 in Canada and AS/NZS 3200.1 in
Australia and New Zealand).
In accordance with European standards they also comply with the electromagnetic
compatibility requirements under IEC60601-1-2, which ensures compliance with the
EMC directive.
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• this is a more rigorous standard than other standards that could be chosen.
• it provides a high safety level for subjects and operators.
• is a medical device,
• may be interpreted as a medical device, or
• is safe to be used as a medical device.
Owner's Guide