NeoBeat Newborn Heart Rate Meter

Laerdal Medical AS

A reusable neonatal ECG heart rate meter.

Courtesy of WHO Compendium 2021

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and 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 region(s) Target region for distribution/implementation (listed by country if specified)

Africa

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Laerdal Global Health

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

150 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Traditional ECG adhesive electrodes, stethoscope, or umbilical cord palpation.

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

The target users for this product are midwives working in hospitals in low-resource settings.

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

NeoBeat is manufactured in Norway.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented: WO 2014/048807 A2

User Provision Model Where can the product be purchased/acquired by end users?

The product can be purchased directly from the manufacturer.

Distribution to date Number of units that have been deployed, downloads or users to date

Between 101-1000 distributions as of October 2020.

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

None

Indispensable equipment for function

Power Supply Type

Rechargeable battery

Maintenance or calibration required by user at time of use?

Alert mechanism

LEDs, audio alarm w/dB level, etc.

Clinical measurements monitored

temperature, oxygen saturation, HR, etc.

Heartrate

Patient population

Newborns

Maximum duration of consecutive usage

days

Unknown

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

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 Design and assembly illustrations

Not available

Technical support Technical support provided by

Provided by the manufacturer.

Replacement components Availability of replacement components (in-country, by order,...)

Replacement components are available separately through the manufacturer.

Lifecycle Disposal and warranty

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 targets Designer / Manufacturer specified targets

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

Vetted performance Findings of manufacturer evaluations or independent testing centers

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.

Testing organizations Independent lab, academic research centers, etc.

Testing was performed by the manufacturer; University Hospital, Norway; and TüV SÜD Product Service GmbH, Germany.

Safety Potential hazards / risks related to operation of this product

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

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

Electricity to recharge batteries

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

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 Product certifications and standards referenced by designer/manufacturer

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 Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

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