Philips IntelliVue TRx, Instructions For Use Manual

Page: 238 / 274

Draft - 1 Aug 08
Regulatory Information
12-2 Safety Standards & Specifications
Regulatory Information
Intended Use
The device is intended to provide ambulatory and bedside monitoring of
ECG and SpO
2
parameters of adult and pediatric patients in professional
healthcare facilities. It is intended to be used by trained healthcare
personnel. It is not intended for home use.
Indications for
Use
Indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients. Intended for
monitoring, recording and alarming of multiple physiological parameters of
adult and pediatric patients in transport and hospital environments.
Rx
Federal Law restricts this device to sale by or on the order of a physician.
Patient
Population
This device is not for use with infant or neonatal patients.
Use of the transceiver is restricted to one patient at a time.
The components/accessories which come into contact with the patient’s skin
are in compliance with the relevant requirements of EN ISO 10993-1 for
Biocompatibility. The transceiver is not designed for direct contact with the
patient’s skin. The accompanying pouch is the appropriate means for
holding the transceiver.
Authorized EU
Representative
Philips Medizin Systeme Deutschland
Hewlett-Packard-Strasse 2
D 71034, Boeblingen
Germany