Specifications Appendix
5 - 2 0070-10-0603-01 Duo™ Operating Instructions
5.1.2 Safety Designations
5.1.3 Hazard Analysis (Risk Management)
5.1.4 Performance/Accuracy
Type of protection against electric
shock
Class 1 with internal electric power source. Where
the integrity of the external protective earth (ground)
in the installation or its conductors is in doubt, the
equipment is operated from its internal electric
power source (batteries).
Degree of protection against
electric shock:
- NIBP - Type BF defibrillation protected
- SpO
2
- Type BF
- Monitor - Type B equipment
Supply Connection: 100 – 240 VAC (+/-10%)
50/60 Hz (+/-3 Hz)
0.7 – 0.4 Amps
7.2 VDC Internal Battery
Mode of Operation: Continuous
Protection Against Hazards of
Explosion:
Not protected (Ordinary)
Protection Against Ingress of
Liquid's:
Not protected (Ordinary) - IPX0 per IEC 60529
Degree of electrical connection
between equipment and patient:
Equipment designed for non-electrical connection to
the patient
Degree of Mobility: Transportable
EN ISO14971:2000 Medical Devices-Application of risk management
analysis to medical devices
EN 865:1997 Pulse Oximeters - Particular Requirements
EN 1060-1:1995 Specification for Non-invasive Sphygmomanometers
EN 1060-3:1997 Non-invasive Sphygmomanometers, Supplementary
Requirements for Electromechanical Blood Pressure
Measuring Systems
To Next Page
Loading...
