EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton
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Appendix 1 Product Specifications
A F15 Fetal/Maternal Monitor
A1.1 Environmental Specifications
The monitor may not meet the performance specifications given here if stored or used outside the
specified temperature and humidity ranges.
Working
Temperature
0 ºC ~ + 40 ºC ( +32 ºF ~ +104 ºF)
Relative Humidity
15% ~ 95% (non-condensing)
Atmospheric Pressure
86 kPa ~ 106 kPa
Transport and Storage
Temperature
-20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)
Relative Humidity
15% ~ 95% (non-condensing)
Atmospheric Pressure
70 kPa ~ 106 kPa
A1.2 Physical Specifications
Monitor
Dimensions and
Weight
Size (depth x width x height)
389 mm x 296 mm x 82.5 mm
Weight
≤8.0 kg
Power Supply
Operating Voltage
100V-240V~
Operating Frequency
50Hz/60Hz
Input Power
1.2A-0.5A
Battery
10.8VDC/5100mAh(±10%)
Wireless
transducer
holder bracket
Input Power
5V/3A
Standards
Compliance
IEC 60601:2005+A1:2012, EN 60601-1:2006+A1:2013,
IEC 60601-1-2:2014, EN 60601-1-2:2015, IEC 60601-1-8: 2012, EN 60601-1-8:
2007+A1: 2013
IEC/EN 60601-2-27,
IEC/EN 60601-2-37,
IEC/EN 60601-2-49,
IEC 80601-2-30,
ISO 80601-2-61,
ISO 80601-2-56.
Anti-electric
Shock Type
Class I equipment with internal power supply
Anti-electric
Shock Degree
MECG,FHR1,FHR2,FHR3,TOCO,MARK,EXT.1,
DECG, IUP, FECG
CF
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English