Facelake FD320 Ultrasound Fetal Doppler with Color LCD Display 

FD320 Pocket Fetal Doppler is the perfect tool for fetal heartbeat monitoring with great color display! With the built-in speaker you can hear the heartbeat, kicks and hiccups! In parallel, there is a port for headphones and other audio recording devices. It can be used from the first 10-12 weeks of pregnancy! FD320 is a compact and energy-saving device that is very easy to use. Two batteries are supplied free of charge! Suitable for doctors, obstetrician, midwives, pregnant women and of course, expectant fathers. It includes a 3.0 MHz probe which has more sensitivity giving a clearer and more accurate monitoring experience.

This fetal Doppler has been scientifically designed to increase the ease of use by expecting moms. Fetal heart rate values, bar graph and heartbeat waveform are all displayed in a colored LCD screen. The special red-alarming feature helps the moms to know when the heartbeat is going out of range so they can adjust the probe to get the strongest heartbeat.

Why do we recommend 3.0 MHz probes for fetal heart detection?


Over 90% of OBs, hospitals, and midwives choose 3.0 MHz probe because they know from the results of millions of exams that 3.0 MHz works better. It works better because the fetus is so small early in gestation that 3.0 MHz reflects the ultrasound back to the sensor better than the lower frequency 2.0 MHz. A 3 MHz has also been proven to work well throughout the pregnancy.

Features


  1. Strong 3.0 MHz probe for a clearer sound output
  2. Powerful built-in speaker for listening the heartbeat without headphones
  3. Color LCD 160×128 pixel
  4. Red-alarm feature which indicates the heartbeats are getting out of range to indicate adjustments.
  5. Uses 2 AA size batteries which are easy to find (2 new batteries are included)- 2 batteries are enough for 15 hours or continuous service
  6. Auto-off feature & low battery consumption to ensures hours & hours of usage
  7. Battery icon which indicates how much battery is left
  8. Headphone jack for listening to the heartbeat
  9. Compact design with buttons which are design to withstand repeated usage without wearing out or breaking
  10. Light and very easy to handle
  11. 3 work modes: real-time FHR display mode, averaged FHR display mode, and manual mode . The FHR can also be displayed in waveform
  12. Auto switch-off

Three Modes


  1. Mode 1: a heart icon is displayed when the heartbeat is detected and the real-time hear t rate is displayed numerically.
  2. Mode 2 : a heart icon is displayed when the heartbeat is detected and it averages the heart rate for a more stable reading.
  3. Mode 3 : this mode allows the user to calculate an average heart rate over a specific period of time by manually pushing a button to start & stop the time.

Package Includes

  1. FD320 Fetal Doppler Unit
  2. Fetal Doppler Probe (Default 3.0MHz)
  3. Two FREE AA Alkaline Batteries
  4. User Manual
  5. Free Gel Tube

Extended Specifications


  1. FDA & CE approved-FDA 510k number: K082480, Device listing number: D072247-Health Canada Registration number: 94645-number: G1140350972028
  2. Safety: Complies with: IEC 60601-1:1988＋A1:1991＋A2:1995
  3. Classification: Anti-electroshock Type: Internally powered equipment.
  4. Classification: Anti-electroshock Degree: Type B applied part
  5. Classification: Harmful Liquid Proof Degree
  6. Classification: Main unit :Ordinary equipment (sealed equipment without liquid proof).
  7. Classification: Probe: Prevent from water splashing, degree of protection: IPX4.
  8. Classification: Degree of Safety in Presence of Flammable Gases: Equipment not suitable for use in
  9. Classification: presence of flammable gases.
  10. Classification: Working System: Continuous running equipment.
  11. Classification: EMC: Group I Class B.
  12. Classification: Suitable Using Range: Suitable for use after the 12th week of pregnancy.
  13. Size: 135mm (Length) *92mm (Width) *29 (Height) mm
  14. Weight: About 245g (including batteries)
  15. Working Temperature: +5℃ - +40℃
  16. Working Humidity: <=80％
  17. Working Atmospheric Pressure: 70 kPa - l06kPa Transport and Storage
  18. Storage Temperature: -10℃ - +55℃
  19. Storage Humidity: <=93％
  20. Storage Atmospheric Pressure: 50 kPa-l06kPa Display: 45mm * 25mm LCD display
  21. FHR Measuring Range: 50-240BPM (BPM: beat per minute)
  22. Resolution: 1BPM
  23. Accuracy: (+/-)2BPM
  24. Power consumption:<0.8W
  25. Auto Shut-OFF: After 1 minute no signal, power off automatically.
  26. Battery Type Recommended: Two pieces of 1.5 V DC battery (SIZE AA LR6).
  27. Probe: Nominal Frequency: 2.0MHz or 3Mhz
  28. Probe: Working Frequency: 2.0MHz(+/-)10% or 3Mhz
  29. Probe: P-: <0.5MPa
  30. Probe: Iob: <10 mW/cm2
  31. Probe: Ispta: <50mW/cm2
  32. Probe: Ultrasonic Output Intensity: Isata<5 mW/cm2
  33. Probe: Ultrasonic Output Power: P < 10 mW
  34. Probe: Working Mode: Continuous wave Doppler
  35. Probe: Effective Radiating Area of Transducer: 157mm2 (+/-)15%

Facelake Medical Supply is a distributor of medical device , located at Buffalo Grove, IL 60089, Please call 847-234-0754 9am/5pm Monday-Friday Central Time with any question

"The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."

If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health:

https://www.fda.gov/cdrh/devadvice/

https://www.fda.gov/cdrh/industry/support/index.html

Phone number: 800.638.2041

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