Welch Allyn 1500 Patient Monitor v.1.4.X - User Manual - Manual (Page 134)

130 Technical data Welch Allyn 1500 Patient Monitor
Safety standards
Safety standard IEC 60601-1/A2: 1995: Delta -consideration related to IEC60601-1:2005 incl.
corrections 1:2006 and 2:2007:General requirements for basic safety and
essential performance. Protection Class I Type CF.
IEC 60601-1-4/A1: 1999: General requirements for collateral standard:
programmable electrical medical systems.
IEC 62366: 2007: Application of usability engineering to medical devices.
IEC 60601-2-27: 2005: Particular requirements for the safety of
electrocardiographic monitoring equipment..
IEC 60601-2-30: 1999:Particular requirements for the safety, including essential
performance, of automatic cycling non-invasive blood pressure monitoring
equipment..
IEC 60601-2-34: 2000:Particular requirements for the safety, including essential
performance, of invasive blood pressure monitoring equipment.
IEC 60601-2-49: 2001:Particular requirements for the safety of multifunction
patient monitoring equipment.
ISO 9919. Particular requirements for the basic safety and essential
performance of pulse oximeter equipment for medical use.
ISO 21647. Particular requirements for the basic safety and essential
performance of respiratory gas monitors.
Protection class Protection against electric shocks, Class I according to IEC/EN 60601-1 (with
internal power).
Protection This monitor is not designed for outdoor use (IPX0).
EMC IEC/EN 60601-1-2: 2007: (class A).
Additional
requirements EN 1060-1 and EN 1060-3 (noninvasive blood pressure recorders part 1).
EN12470-4 (Performance of electrical thermometers for continuous
measurement).
Conformity CE according to directive 93/42/EEC class IIb.