Compliance - Schiller Argus VCM Gebrauchsanweisung

Specifications

Compliance

Classification
Type of
protection
General Safety
Alarms
Non-invasive
blood pressure
Oxygen
saturation
Temperature
monitoring
Electromagnetic
Compatibility
Labeling
Marking
92
ARGUS VCM
Item
Class I (on AC power) Internally powered (on battery power)
Type BF – Applied part
IEC60601-1:1998+A1:1991+A2:1995
General requirements for Safety and Essential Performance
IEC60601-1-8:2001 Draft
Alarm systems requirements, tests and guidances in medical
electrical equipments systems
AAMI SP10:1992+A1:1996
Electronic or Automated Sphygmomanometers
EN1060-1:1995 Non-invasive sphygmomanometers
EN1060-3:1997
Supplementary requirements for electrical-mechanical blood
pressure measuring systems
IEC60601-2-30:1999
Particular requirements for the Safety, including essential
performance, of automatic cycling indirect blood pressure
monitoring equipment
EN865:1997 Pulse oximeters, Particular requirements
E1112-00
Electronic thermometer for intermittent determination of patient
temperature
EN12470-3:2000
Performance of compact electrical thermometers (non-predictive
and predictive) with maximum device
IEC 60601-1, sub clause 36, IEC/
IEC60601-1-2:2001
Electromagnetic compatibility-requirements & test
EN1041:1998
Information supplied by the manufacturer with medical devices
IEC 60878, EN 980, ISO 7000, EN 60417-1, EN 60417-2
Operator's Manual
Compliant with
ARGUS VCM