Updated on March 9, 2024

·

Created on August 30, 2021

NeoBeat Newborn Heart Rate Meter

Upcoming Update

A reusable neonatal ECG heart rate meter. Courtesy of WHO Compendium 2021

Tested By
  • Laerdal Global Health
  • TUV SUD Management Service GmbH
Content Partners
Unknown

Author

Product Description

NeoBeat is a reusable, consumable-free heart rate meter that provides an accurate and continuous display of newborn heart rate. The device takes seconds to put on a newborn’s abdomen, and the instantaneous heart rate can help guide neonatal resuscitation.

This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.

Target SDGs

SDG 3: Good Health and Well-Being

Market Suggested Retail Price

$149.99

Target Users (Target Impact Group)

Household, Small and Medium-sized Enterprises, NGOs

Distributors / Implementing Organizations

Laerdal Global Health

Competitive Landscape

Direct competitors include Spandan ECG.

Manufacturing/Building Method

NeoBeat is manufactured in Norway.

Intellectural Property Type

Patent

User Provision Model

The product can be purchased directly from the manufacturer.

Distributions to Date Status

Between 101-1000 distributions as of October 2020.

Alert mechanism

No

Clinical measurements monitored

Heartrate

Patient population

Newborns

Maximum duration of consecutive usage

Unknown

Design Specifications

The device uses dry stainless steel electrodes (recommended by ILCOR 2015 guidelines) embedded in a spring-elastic buckle to read ECG signals from newborns. To use the device, remove it from the charging stand, spread the electrode arms slightly, and apply over the newborn's chest. After ~5 seconds, the device will display the newborn's ECG heart rate. The product includes a rechargeable battery, signals processor, and LED-display, and weighs 0.031 kg.

Product Schematics

Technical Support

Provided by the manufacturer.

Replacement Components

Replacement components are available separately through the manufacturer.

Lifecycle

The device has a lifetime of 2-5 years, and a 1-year warranty is provided with purchase. The battery has a lifetime of 3-6 years.

Manufacturer Specified Performance Parameters

The manufacturer specifies that the device is easy to use and maintain, accurate, affordable, and durable.

Vetted Performance Status

Neonate was tested for usability in Norway, India, Tanzania, and the UK with gynecologists, pediatricians, midwives, and pediatric nurses. Testing by University Hospital in Norway found that the device conforms with IEC 62366 and CE-marking.

Safety

This device should only be used by trained professionals. Additionally, the device should be disinfected with 70% ethanol between uses.

Complementary Technical Systems

Electricity to recharge batteries

Academic Research and References

Bush J.B., Cooley V., Perlman J., Chang C., 2021,  NeoBeat offers rapid newborn heart rate assessment. Arch Dis Child Fetal Neonatal Ed. doi: 10.1136/archdischild-2020-320901. Epub ahead of print. PMID: 33478958

Lee A., et al., 2013, Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990. Pediatric Research, Vol. 74(s1).

Linde J., et al., 2016, Normal Newborn Heart Rate in the First Five Munites of Life Assessed by Dry-Electrode Electrocardiography. Neonatology, Vol. 110(3), pp. 231-237.

Compliance with regulations

This device complies with the following standards: IEC 60601-1, IEC 60601-1-6, IEC 62304, IEC 62366-1, and ISO 10993, and is CE-marked.

Evaluation methods

This product has been evaluated for usability in studies in Nepal, Tanzania, Uganda, and DR Congo and is part of the Safer Births research program.

Other Information

None  

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