GENERAL DESCRIPTION
Doppler, fetal heart rate detector, monitor, w/accessories
Handheld doppler based foetal heart rate detector with amplifier loudspeaker.
INTENDED USE
Ultrasonic fetal heart detectors are low-cost devices used in a variety of healthcare settings to provide audible and visual information about the fetes. Certain conditions, such as vaginal bleeding of lack of fetal movement, can cause anxiety in the mother, making her question the health of her unborn baby. The primary purpose of the fetal heart detector is to provide quick reassurance of fetal well-being to both the mother and the healthcare worker. The fetal heartbeat cannot be heard with an obstetric stethoscope until 24 weeks after conception. Ultrasonic fetal heart detectors can easily detect fetal heart motion throughout the pregnancy, starting as early as 8 weeks.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Doppler, foetal heart rate (FHR) detector, with accessories To be used in basic health infrastructures for routine examination of foetal life, from about 10-12 weeks gestation through to delivery.
Self-test is performed each time the device is switched Capable of detecting foetal heart rates (FHRs) in the range of 50 - 210 bpm, with 1 bpm resolution and 2 bpm accuracy. System reports, with audio-visual alert: operational status, malfunctions and low battery.
Advanced noise/disturbance suppression system assures quality diagnostic sound
Probe (transducer) with 2 MHz frequency with a probe attached via a cable.
Regular size, approx.: 18 to 20 cm.
The cable can be extended to a 25 cm length when stretched.
Probe detector head diameter at least 39 mm.
Handheld, weights less than 0.45 kg with probe and batteries.
Built-in speaker with volume adjustment.
LCD screen displays FHR, pulse indicator and battery status
Visual alerts for status, system error and low battery
Operates on 3 x AA batteries.
Battery life is sufficient for 10 hours continuous use.
SUPPLIED WITH
1 x Soft carry bag easy to clean
1 x Instructions manual (instructions for assembly, use and maintenance in English, French, and Spanish)
OPTIONAL ACCESSORIES AVAILABLE
At extra costs additional optional features can be requested:
- The probe is interchangeable and probes with other frequencies are available: 4Mhz, 5Mhz and 8Mhz."
INSTRUCTION FOR USE
To be used in basic health infrastructures for routine examination of fetal life, from about 10-12 weeks gestation through to delivery.
Doppler fetal heart rate detector should be operated by an adequately trained person only.
Clean and disinfect the device after each use.
Doppler fetal heart detector must be used and maintained according to manufacturer's instructions"
ACCESSORIES/ SPARE PARTS / CONSUMABLES
Ultrasound gel, batteries
PACKAGING & LABELLING
Unit presentation: 1 (one) Doppler, FHR detector, with accessories and Instructions for use.
Symbols used according ISO 15223
CE with notified body number
REGULATORY & CONFORMITY REQUIREMENTS
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
CLASSIFICATION
Classified under EU MDR 2017/745 as Class IIa device
Doppler, fetal heart rate detector, monitor, w/accessories
Handheld doppler based foetal heart rate detector with amplifier loudspeaker.
INTENDED USE
Ultrasonic fetal heart detectors are low-cost devices used in a variety of healthcare settings to provide audible and visual information about the fetes. Certain conditions, such as vaginal bleeding of lack of fetal movement, can cause anxiety in the mother, making her question the health of her unborn baby. The primary purpose of the fetal heart detector is to provide quick reassurance of fetal well-being to both the mother and the healthcare worker. The fetal heartbeat cannot be heard with an obstetric stethoscope until 24 weeks after conception. Ultrasonic fetal heart detectors can easily detect fetal heart motion throughout the pregnancy, starting as early as 8 weeks.
PRODUCT DESCRIPTION / TECHNICAL SPECIFICATIONS
Doppler, foetal heart rate (FHR) detector, with accessories To be used in basic health infrastructures for routine examination of foetal life, from about 10-12 weeks gestation through to delivery.
Self-test is performed each time the device is switched Capable of detecting foetal heart rates (FHRs) in the range of 50 - 210 bpm, with 1 bpm resolution and 2 bpm accuracy. System reports, with audio-visual alert: operational status, malfunctions and low battery.
Advanced noise/disturbance suppression system assures quality diagnostic sound
Probe (transducer) with 2 MHz frequency with a probe attached via a cable.
Regular size, approx.: 18 to 20 cm.
The cable can be extended to a 25 cm length when stretched.
Probe detector head diameter at least 39 mm.
Handheld, weights less than 0.45 kg with probe and batteries.
Built-in speaker with volume adjustment.
LCD screen displays FHR, pulse indicator and battery status
Visual alerts for status, system error and low battery
Operates on 3 x AA batteries.
Battery life is sufficient for 10 hours continuous use.
SUPPLIED WITH
1 x Soft carry bag easy to clean
1 x Instructions manual (instructions for assembly, use and maintenance in English, French, and Spanish)
OPTIONAL ACCESSORIES AVAILABLE
At extra costs additional optional features can be requested:
- The probe is interchangeable and probes with other frequencies are available: 4Mhz, 5Mhz and 8Mhz."
INSTRUCTION FOR USE
To be used in basic health infrastructures for routine examination of fetal life, from about 10-12 weeks gestation through to delivery.
Doppler fetal heart rate detector should be operated by an adequately trained person only.
Clean and disinfect the device after each use.
Doppler fetal heart detector must be used and maintained according to manufacturer's instructions"
ACCESSORIES/ SPARE PARTS / CONSUMABLES
Ultrasound gel, batteries
PACKAGING & LABELLING
Unit presentation: 1 (one) Doppler, FHR detector, with accessories and Instructions for use.
Symbols used according ISO 15223
CE with notified body number
REGULATORY & CONFORMITY REQUIREMENTS
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
CLASSIFICATION
Classified under EU MDR 2017/745 as Class IIa device
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $171.02 |
