Performance and safety information.

Intended use and contraindications

Version 1.4.x

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Intended use

WARD-CSS is a clinical decision support system that remotely integrates, analyzes and displays continuous vital sign data (via a mobile or web application) from medical vital signs sensors within non-critical care units.

WARD-CSS uses a set of standardized rules based on scientific and clinical evidence to detect and alert on clinically relevant vital sign deviations and changes.

WARD-CSS is not intended to replace current (intermittent) monitoring practices.

Indications for use

WARD-CSS is indicated for non-paediatric hospitalized patients in non-critical condition.

Target population

WARD-CSS is intended to be used on adult patients continuously monitored by multi-parameter devices.

The intended patient population includes all general (surgical and medical) units within a hospital, except for intensive care units and is therefore intended to be used with patients in serious but not critical condition/situation.

Contraindications

  • Children and adolescent, i.e. patients younger than 18 years of age
  • Pregnant and breastfeeding women