Safety Notes; Statement Of Intended Use; Safety And Quality Standards - ADInstruments POWERLAB TEACHING SERIES 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

In accordance with European standards PowerLab systems also comply with the
electromagnetic compatibility requirements under EN61326-1, which encompasses the
EMC directive.
Quality Management System ISO 9001:2008
ADInstruments manufactures products under a quality system certified as complying
with ISO 9001:2008 by an accredited certification body.
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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.
PowerLab Teaching Series - Owner's Guide