Appendix Ii Product Specification - Fazzini FM5000C User Manual

1. Monitor Type
Item
Type of protection against
electric shock
Degree of protection
against electic shock
Safety standard
Ingress protection
Safety level if there is any
mixture of flammable
anesthetic gas and air or
oxygen/nitrous oxide (not
applicable)
Work mode
2. Monitor Specifications
(1) Dimension and Weight
Item
Dimension and weight
Fuse
(2) Environmental Requirements
Item Specification
Work Ambient temperature
environment
Relative humidity
Atmospheric pressure
Transport and Ambient temperature
storage
Relative humidity
environment
Atmospheric pressure
Please protect the Monitor against violent impact, vibration and water in transport.
Power supply Rated input voltage
Rated frequency
Rated input power

Appendix II Product Specification

Type
Class I with internal power supply.
BF applied parts TOCO, FHR, FM, WAKE, NIBP, TEMP, SpO2
CF applied parts ECG
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
IPX1
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
Specification
Dimension: 340mm (L) ×270mm (W) ×95 mm (H)
Weight: 5.5Kg (including battery)
Φ5×20MM
T1.6A L250V
100-240V～
50Hz/60Hz
80VA
II-1
FM5000C - FM5000PLUS
Maternal/Fetal Monitor
5℃～40℃
≤93%
700hPa～1060hPa
-20℃～+60℃
≤93%
700hPa～1060hPa
User Manual