Edan F3 CTG Monitor

Description

EDAN F3 CTG Monitor

Fetal Monitor F3
Colour TFT Screen
Easy to Carry and Operate
Advanced FHR detection technology
Built in Printer
Battery
Data management on PC
Suitable for Outpatient Service

• Foldable color screen Foldable color screen
• Backup memory for seamless monitoring Backup memory for seamless monitoring
• Built-in long life thermal printer Built-in long life thermal printer
• Compatible with 150/152 mm thermal recording paper Compatible with 150/152 mm thermal recording paper
• Large numeric and graphic display for ease of readability Large numeric and graphic display for ease of readability
• FHR signal quality indicator FHR signal quality indicator
• Signals Overlap Verification to separate twins FHR Signals Overlap Verification to separate twins FHR
• Fast printing of stored traces Fast printing of stored traces
• Long life Li-ion battery guarantees the mobility of F3 Long life Li-ion battery guarantees the mobility of F3
• PC management software and central monitoring system supportive PC management software and central monitoring system supportive
• Convenient probe rack and compact design Convenient probe rack and compact design
• USB port enables memory expansion USB port enables memory expansion
• DECG & IUP parameters optional
• DECG & IUP parameters optional

EDAN F3 CTG Monitor Product Specifications

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: +5 ºC ~ + 40 ºC ( +41 ºF ~ +104 ºF)
Relative Humidity: 15% ~93% (non-condensing)
Atmospheric Pressure: 86 kPa ~ 106 kPa

Transport and Storage

Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)
Relative Humidity: 15% ~ 93% (non-condensing)
Atmospheric Pressure: 70 kPa ~ 106 kPa

Physical Specifications

Dimensions and Weight:
Size (depth x width x height) : 350mm x 300mm x 104mm
Weight: Approx. 3.5 kg

Power Supply

Operating Voltage: 100V-240V~
Operating Frequency: 50Hz/60Hz
Input Power : 70VA
Battery: 14.8VDC/5000mAh

Standards Compliance

IEC 60601-1:2005/A1:2012, EN 60601-1:2006/A1:2013,
IEC 60601-1-2:2014, EN 60601-1-2:2015, IEC/EN 60601-2-37

Anti-electric Shock Type: Class I equipment with internal power supply

Anti-electric Shock Degree:
FHR1, FHR2, TOCO, FM, FS: BF
IUP: BF
DECG: CF

Degree of Protection against Harmful Ingress of Water for the Transducers:
IPX 8 (FHR1,FHR2,TOCO)

EMC: CISPR 11 Group 1 Class A
Working System: Continuous running equipment

Earth Leakage Current (Limit):
N.C.: 500μA
S.F.C.: 1000μA

Enclosure Leakage Current (Limit)
N.C.: 100μA
S.F.C.: 500μA

Patient Leakage Current (Limit)
N.C. d.c.: 10μA 50μA
S.F.C. a.c. 10μA 50μA

Patient Auxiliary Current (Limit)
N.C.: d.c. 10μA 50μA
S.F.C.: a.c. 10μA 50μA

Display

LCD Size: 5.6”|
Resolution: 640 (RGB) x 480

Signal Interface DB9, RJ45 network interface

Ultrasound Transducer

Weight: 190g
Cable Length: 2.5m
Dimension: 88mmÅ~35mm

TOCO Transducer

Weight: 180g
Cable Length: 2.5m
Dimension: 88mmÅ~35mm

Remote Event Marker

Length: 2.5m
Weight: 56g

Performance Specifications

Ultrasound
Technique: Ultrasound Pulse Doppler with autocorrelation
Pulse Repetition Rate: 2 KHz
Pulse Duration: 92 μs
Ultrasound Frequency: ( 1 .0 ±10%) MHz
p- <1 MPa
Iob <10 mW/cm2
Ispta <100 mW/cm2
*Isata <20 mW/cm2
*Isppa.3<190W/cm2
*Ispta.3<94mW/cm2
|Max Output Power <15mW
Effective Radiating Area: 628 mm2 ± 15%

*FHR Measurement Range: 50 bpm ~ 240 bpm
*Resolution: 1 bpm
*Accuracy: ±2 bpm

*Temperature Rise:

When applied to the patient, the ultrasound transducer may warm slightly (less than 2°C (3.6ºF) above ambient temperature. When NOT applied, at the ambient temperature of 40°C (104ºF), the ultrasound transducer may reach the highest temperature of 43°C (109.4ºF).

Dielectric Strength: > 4000Vrms
ISATA@ the transducer face: 1.865 mW/cm2
Entrance beam: 6.08 cm2
Measurement uncertainties for ISATA: +26.6%
Measurement uncertainties for ultrasonic power: +26.6%

DECG (optional)

Technique: Peak-peak detection technique
*DFHR Measurement Range: 30bpm ~ 240bpm
*Resolution: 1bpm
*Accuracy: ±1bpm
Input Impedance: > 10M (Differential, DC50/60Hz)
Input Impedance: > 20M (Common Mode)
CMRR: > 110dB
Noise: < 4μVp
Skin Voltage Tolerance: ±500mV
Fetal Input Voltage Current: 20μVp ~ 3mVp
*TOCO Range: 0 ~ 100
*Non-linear Error: ±10%

TOCO

Baseline Drift due to
Temperature Changes
≤ 1 unit/min/°C (free air)
≤ 5 units/min/°C (underwater)
*Resolution: 1
Zero Mode: Automatic/ Manual

IUP (optional)

*Pressure Range: 0mmHg ~100mmHg (0.0 kPa~13.3 kPa)
Sensitivity: 5μV/V/mmHg
*Non-linear Error: ±3mmHg (±0.4 kPa)
*Resolution: 1mmHg (0.1 kPa)
Zero Mode: Manual

AFM

Technique: Pulsed Doppler ultrasound
Marking Manual fetal movement mark

NOTE:The essential performance is marked with an asterisk *.

Recorder Specifications

Paper:
Z-fold, thermosensitive (compatible with GE and PHILIPS recorder paper)
Paper width: 152mm (GE), 150mm (PHILIPS)
Effective printing width:
110mm (American Standard)
120mm (International Standard)
FHR printout width:
|70mm (American Standard)
80mm (International Standard)

FHR scaling:
30bpm/cm (American Standard)
20bpm/cm (International Standard)
TOCO printout width: 40mm
TOCO scaling: 25%/cm
Printing speed:
Standard Speed (Real-Time Traces ): 1 cm/min, 2 cm/min, 3 cm/min
Fast Print Speed (Stored Traces): Up to 15mm/sec
Accuracy of data: ± 5% (X axis)
Accuracy of data: ± 1% (Y axis)
Resolution: 8 dots/mm

Record Information:

FHR1 trace/mark, FHR2 trace/mark, TOCO trace, AFM trace/black mark, fetal movement mark, event mark, fetal stimulation mark, AUTO-zero symbol, date, time, printing speed, ID, name, FHR2 Offset etc.

Lithium-ion Battery Specifications

Battery Specification:
01.21.064143 Nominal Capacity 5000mAh
Working Time: >7 hours (depending on configuration)
Nominal Voltage 14.8V
Charge Time <6 hours
Cycle Life ≥300 times