Freeplay FHRM

Target Regions

Africa, Australia-New Zealand Region, Central America, Central Asia, East Asia, East Asia and Pacific, Europe, South America

Target SDGs

Market Suggested Retail Price

$850.00

Target Users (Target Impact Group)

Community, Small and Medium-sized Enterprises

Distributors / Implementing Organizations

Manufactured and distributed by Ultrasound Technologies Ltd via regional distributors in Europe, Africa, South and Central America, Asia, Middle East, Australia and New Zealand.

Competitive Landscape

Direct competitors include Moyo Fetal Heart Rate Monitor and Heartstrings for fetal heart tones.

Regions

Africa, Australia-New Zealand Region, Central America, Central Asia, East Asia, East Asia and Pacific, Europe, South America

Manufacturing/Building Method

Units are batch built and held in stock for future orders. Interview with representative in 2018

Intellectural Property Type

Trade Secret

User Provision Model

Units may be purchased from distributors in respective countries. Interview with representative in 2018

Distributions to Date Status

532 units have been deployed as of July 2015 Interview with representative in 2018

Design Specifications

The FreePlay FHRM includes a probe that uses Doppler ultrasound waves to detect the fetal heart. It runs off rechargeable batteries that are inside the device. The batteries may be recharged from three different power sources: mains electricity; manual, wind-up power and solar energy.

The fetal heart can be “heard” on the loudspeaker while the fetal heart rate is shown on the display screen. The fetal monitor is most useful in assessing the condition of the fetus during labour.

The unit features an On/Off Button, LED display screen, flashing heart icon to indicate each heartbeat, loudspeaker, wind-up handle, indicator light that shows power is being generated, connecting lead from monitor to probe, ultrasound probe, and a mains adaptor, power cable, and DC input socket. Weight is <600 grams.

Product Schematics

Technical Support

Ultrasound Technologies Ltd staff and reselling partners provide support Interview with representative in 2018

Replacement Components

Replacement pieces are available from the original supplier or if user contacts PET (Powerful Education Technology) via info@pet.org.za

Lifecycle

A 3-year is included with FHRM purchase. Interview with representative in 2018

Manufacturer Specified Performance Parameters

• No disposable batteries or power supply required: hand-cranking the charger for 1 minute provides 10 minutes worth of operation.

• It takes approximately 2 hours to fully charge the built-in rechargeable batteries. The fetal monitor will operate for ~7 hours continuously before the batteries need recharging again.

Vetted Performance Status

Through a randomized controlled study in Dar es Salaam, Tanzania, it was demonstrated that FHRM provides better perinatal outcomes in comparison to a fetal stethoscope. Additionally, when evaluating the usability perceptions of midwives, they found barriers for the adoption of this technology, like insufficient training, convenience of use, comfort and limited privacy.

Safety

Must not be used on a patient when connected to the main supply.

Complementary Technical Systems

None

Academic Research and References

Compliance with regulations

The FHRM complies with the essential requirements of the European Council Directive 93/42/EEC + 2007/47/EC. Safety Classification: Class 1 Type B - IEC 60601-1

Evaluation methods

Field testing was conducted in South Africa by the design team.

Usability tests and trials to find associations between usage and the detection of abnormal fetal heart rates were conducted in Tanzania.

Other Information

Distributed through Ultrasound Technologies Ltd via regional distributors http://www.doppler.co.uk/Purchase/Distributors.html