Introducon4
Product Compliance: Safety Standards
The XSENSOR Pressure Imaging System complies with the following
standards:
√ IEC 60601-1:2005, CSA C22.2 No. 60601-1:2008, ANSI/AAMI ES 60601-1/
A2:2010, UL 60601-1:2003
√ Mode of Operaon
√ Class I Medical Equipment
√ Type B Applied Part. Only the sensor(s) touch the paent in normal use.
The ForeSite SS is intended for use by healthcare professionals only.
ForeSite SS must be installed and used as described in this user manual.
This system is designed in compliance with medical safety standards and is
intended for the use of clinicians only. It is not recommended for private use
or client use without the assistance of a trained medical professional. There
are no known contraindicaons to its use. For any quesons or concerns in
regards to the safety of this product, do not hesitate to contact XSENSOR
(see Appendix 4).
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