Fetal monitor is bedside units that consist of a monitoring unit, cables, and electrodes. They are designed to measure, record, and display FHR, uterine contractions, before and during childbirth.
1. Microprocessor controlled equipment.
2. LCD display with visualization of at least fetal heart rate.
3. Integrated fetal heart processing software.
4. Ultrasound working frequency in the range 2MHz -10% to 3MHz +10%.
5. Toco to be used for monitor uterine activity
6. Remote marker event
7. Two ultrasound for twins detection
8. Sensitivity to detect fetal heart beats of at least a 10-12 weeks’ fetus.
9. At least two high sensitivity equipment compatible probes provided: 2 and 3 MHz
10. Heart rate measurement range not smaller than 50-210 bpm with resolution not higher than 2 bpm.
11. Audio output reproduction of the fetal heart rate with integrated speaker and with headphones.
12. Audio volume control system integrated.
13. At least 1 of system compatible headphones provided.
14. At least one integrated serial port for PC connection and data transmission.
15. Memory storage capacity of at least 4 hours of working data.
16. Cable for data transmission.
17. 1 pair of spare system compatible headphones.
19. Integrated battery minimum 3 hours operating time
20. Continuous tracing for fetal heart rate and uterine activity and print on thermal recorder
Five Latex free reusable abdominal belt
20 pack of fetal monitor paper
10 bottles of gel
Clinical purpose: Detect, measure, and display fetal heart activity.
Level of use: Health center, district hospital, provincial hospital, specialized hospital, General hospital
Clinical Departments/Ward: Obstetrics and Gynecology, gynecology physician office
Risk classification: Class B (GHTF Rule 10-1); Class II (USA); Class II (EU, Japan, Canada and Australia)
Regulatory approvals: FDA or CE
ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes (Australia, Canada and EU)