
Fetal Monitor
- Description
Description
Product description:
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. Technical characteristics: 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. 18. Trolley 19. Integrated battery minimum 3 hours operating time 20. Continuous tracing for fetal heart rate and uterine activity and print on thermal recorder Accessories Five Latex free reusable abdominal belt Belt clips 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 International Standard: |
ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes (Australia, Canada and EU)