What is ADInstruments manufactured products Statement for Intended Use?

ADInstruments is conscious of the critical safety issues involved when connecting electrical devices to subjects. We invest significant resources to ensure that our products are approved to strict international safety standards, and have our systems tested by independent certification bodies. In addition, ADInstruments products are designed, manufactured and serviced under the internationally recognized ISO9001:2008 quality management system.
All ADInstruments manufactured products 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.

Where a product meets IEC 60601-1 it is under the principle that:

  1. it is a more rigorous standard than other standards that could be adopted and
  2. it provides the most appropriate safety level for subjects and operators.

The choice to meet IEC 60601-1 is in no way to be interpreted to mean that a product:

  1. is a medical device;
  2. may be interpreted as a medical device;
  3. is safe to be used as a medical device