Model note · Fetal Monitor
EDAN F9 / F9 Express Fetal & Maternal Monitor
The Edan F9 is a bedside cardiotocograph with a 12.1 inch screen for non-stress testing from 28 weeks and for labour monitoring. It measures fetal heart rate by pulsed Doppler or direct fetal ECG and uterine activity by toco or intrauterine catheter. The F9 Express adds maternal ECG, SpO2, NIBP and temperature, and both work with Edan's FTS-3 wireless telemetry transducers.
The model
Maker, model and type.
- Maker
- Edan Instruments, Inc.
- Model
- F9 / F9 Express Fetal & Maternal Monitor
- Device type
- Fetal Monitor
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| FHR technique | Pulsed Doppler with autocorrelation processing, 2 kHz pulse repetition frequency | Source |
| Ultrasound transducer | 12 crystals, effective radiating area 942 mm2 plus or minus 15% (F9 and F9 Express) | Source |
| DECG and MECG heart rate range | 30 to 240 bpm; MECG rate averages the 12 latest RR intervals | Source |
| TOCO and IUP | TOCO 0 to 100, resolution 1; IUP 0 to 100 mmHg, 5 uV/V/mmHg, auto zero or manual | Source |
| Maternal SpO2 and NIBP (F9 Express) | SpO2 50 to 100%, PR 30 to 240 bpm plus or minus 3 bpm; NIBP systolic 40 to 270 mmHg, diastolic 10 to 215 mmHg, mean error within plus or minus 5 mmHg, SD 8 mmHg | Source |
| Recorder | 152 mm (GE) or 150 mm (Philips) paper; 1, 2 or 3 cm/min | Source |
| Display, size and weight | 12.1 in LCD; 347 x 330 x 126 mm; about 5.5 kg (F9) or 6.3 kg (F9 Express) | Source |
| Power | 100 to 240 VAC, 50/60 Hz, 1.0 to 0.5 A; rechargeable lithium ion battery | Source |
| Ingress protection | Main unit IPX1 (recorder drawer shut, not wall mounted vertically); US and TOCO transducers IPX8 | Source |
| Applied part classification | FHR, TOCO, FM, IUP type BF; DECG type CF; SpO2 and NIBP BF defibrillator proof; ECG and TEMP CF defibrillator proof | Source |
| Environment | Operating 5 to 40 C, 15 to 93% RH non condensing, 86 to 106 kPa | Source |
| FDA clearance | K173042 (F6, F6 Express, F9, F9 Express; F2, F3), product code HGM, Class II, decision 30 August 2018 | Source |
Recalls
Known FDA recalls.
- Z-1141-20262025-10-24
Cybersecurity labelling correction: a public IP address was used as the factory default and as a manual example; customers to check IP settings and file the manual corrigenda.
FDA record
Safety
Safety warnings from the record.
- The monitor is not suitable for use in the presence of flammable gases. Source
- Only trained staff in antepartum, labour and delivery rooms should use it, and non-stress testing is cleared from 28 weeks of gestation. Source
- A monitor left on a public default IP address is a network security exposure; quarantine affected stock until the correction is applied. Source
- The main unit is only drip proof (IPX1); only the transducers are rated for immersion (IPX8). Source
Sources
Where this note comes from.
- FDA 510(k) K173042 summary, Edan F6/F9 Fetal & Maternal Monitors and F2/F3 Fetal Monitors
- openFDA recall search, Edan
- openFDA MAUDE problem counts, Edan perinatal monitors (HGM)
Not covered: Edan's own website did not return readable content and no public F9 user or service manual could be opened, so there are no error codes, alarm messages, part numbers or battery runtime; reseller battery figures conflict (2 h against 4 h) and were left out. Almost all facts come from one FDA 510(k) summary. MAUDE has only a handful of Edan perinatal reports, too few for a trend, and the battery entry is a generic wear item rather than evidence of failures.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Fetal Monitor