User's Manual

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.