FM5000C - FM5000PLUS
Maternal/Fetal Monitor
Appendix II Product Specification
1. Monitor Type
Type of protection against
electric shock
Class I with internal power supply.
Degree of protection
against electic shock
TOCO, FHR, FM, WAKE, NIBP, TEMP, SpO2
MDD 93/42/EEC as amended by MDD 2007/47/EC,
EN ISO13485:2012+AC2012, EN ISO14971: 2012,
EN60601-1:2006/A1:2013, EN 60601-1-2:2007/AC:2010, EN 1041: 2008,
EN980:2008, EN ISO 80601-2-56:2009, EN60601-2-27:2006, IEC
60601-2-49:2011, IEC 80601-2-30:2009, EN 1060-1:1995+ A2:2009,
EN60601-1-8:2007/AC:2010, EN ISO10993-1:2009,
EN 1060-3:1997+A2:2009, EN ISO 80601-2-61:2011, EN1060-4:2004,
EN62304:2006, EN62366:2008, EN60601-1-6:2010, EN60601-2-37:2008,
EN ISO 10993-5:2009, EN ISO 10993-10:2010, EN ISO 80601-2-55:2011
Safety level if there is any
mixture of flammable
anesthetic gas and air or
oxygen/nitrous oxide (not
applicable)
The monitor is not allowed to be used if there is any mixture of flammable
anesthetic gas and air, or mixture of flammable anesthetic gas and oxygen
or nitrous oxide.
Continuous running equipment
2. Monitor Specifications
(1) Dimension and Weight
Dimension: 340mm (L) ×270mm (W) ×95 mm (H)
Weight: 5.5Kg (including battery)
(2) Environmental Requirements
Transport and
storage
environment
Please protect the Monitor against violent impact, vibration and water in transport.