Fazzini FM5000C - Appendix II Product Specification

II-1
FM5000C - FM5000PLUS
Maternal/Fetal Monitor
User Manual
Appendix II Product Specification
1. Monitor Type
Item
Type
Type of protection against
electric shock
Class I with internal power supply.
Degree of protection
against electic shock
BF applied parts
TOCO, FHR, FM, WAKE, NIBP, TEMP, SpO2
CF applied parts
ECG
Safety standard
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
Ingress protection
IPX1
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.
Work mode
Continuous running equipment
2. Monitor Specifications
(1) Dimension and Weight
Item
Specification
Dimension and weight
Dimension: 340mm (L) ×270mm (W) ×95 mm (H)
Weight: 5.5Kg (including battery)
Fuse
Φ5×20MM T1.6A L250V
(2) Environmental Requirements
Item
Specification
Work
environment
Ambient temperature
5℃～40℃
Relative humidity
≤93%
Atmospheric pressure
700hPa～1060hPa
Transport and
storage
environment
Ambient temperature
-20℃～+60℃
Relative humidity
≤93%
Atmospheric pressure
700hPa～1060hPa
Please protect the Monitor against violent impact, vibration and water in transport.
Power supply
Rated input voltage
100-240V～
Rated frequency
50Hz/60Hz
Rated input power
80VA