Embrace Infant Warmer

Embrace

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
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Product description Brand name and product description

The Embrace Warmer is an easy-to-use, portable warmer for hypothermic infants in low-resource settings. It is designed to be used anywhere and does not need continuous power. Embrace has been adopted by doctors, nurses and new mothers for use in NICU, maternity ward and transport.

Target region(s) Target region for distribution/implementation (listed by country if specified)

East and West Africa and India. Pilots are underway for Afghanistan, China, Guatemala, Mexico, Somalia, South Sudan, Uganda and Zambia.

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

Embrace Global and Embrace Innovations (Ei)

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

The Embrace infant warmer costs approximately $200. The components of the warmer—the AccuTemp heater, WarmPak warming pad, and BabyWrap insulated wrap – are included in this cost.

Less than 1% of the cost of a standard incubator

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

Commercially available incubators, radiant warmers, hot water bottles, thermocool boxes, light bulbs

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

Goal 3: to improve and promote good health.

Preventable and treatable complications related to premature and low birth weight, including hypothermia.

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

Embrace is designed for use by clinically trained caregivers as an infant warmer in the clinic, or during transport.

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

Mass produced in India via Embrace Innovations (Ei) which handles the design, manufacturing, and clinical testing of the infant warmer device.

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

Trade secret.

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

Embrace operates within a hybrid non-profit/ for-profit model to achieve large-scale impact on neonatal hypothermia and other complex maternal/child health issues. The 501(c)(3) non-profit organization – Embrace – donates infant warmers for free through partnerships with local NGOs to the neediest clinics. The for-profit social enterprise – Embrace Innovations (Ei) – sells the warmers to government bodies and private entities (such as clinics) that can afford to pay for them. Since Embrace works within a program model, they are unable to sell the warmers individually.

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

More than 50,000 units have been distributed until April, 2014

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

Accuracy of temperature control (deg C)

WarmPak: 36-37⁰C for at least 4 hours. AccuTemp Heater: heats to specific WarmPak target temperature.

Accuracy of temperature display (deg C)

Unknown

Alarm level

Unknown

Alarm type

Unknown

Use Duration (hours)

4-6

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

The Embrace Warmer rapidly stabilizse the temperature of an infant suffering from hypothermia and keeps that temperature for 4 hours. The Embrace achieves this via use of a phase-change material (PCM) in the WarmPak. Once the Warmpak is heated, it slots into the Babywrap and regulates warmth at a temperature of 37°C for a period of 4 hours.The Embrace Warmer components included in the Starter Pack are:

WarmPak: Maintains temperature of ~37⁰C for at least 4 hours. Must be reheated in the AccuTemp heater for 30 minutes, every 4 to 6 hours. (380mm x 220mm, 1.3kg)
BabyWrap: Reusable and easy to sanitize using disinfectants or soap wash (520mm x 250mm, 0.3kg)
AccuTemp Heater: Precision heating mechanism prevents overheating of WarmPak. Requires intermittent access to electricity. (440mm x 290mm x 70mm, 2.5kg) The AccuTemp heater peak power consumption is 500 Watts at 230 V, and approximately 15 Watts in ready mode.

The Embrace Warmer is intended to provide warmth to clinically stable newborns weighing between 1.5 -2.5 kilograms.

Product schematics Design and assembly illustrations

Not available.

Technical support Technical support provided by

Technical support can be provided by phone (Customer Service: +1 800 1033 123)

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

The Embrace Warmer can be reused up to 50 times, the BabyWrap can be sanitized with a disinfecting cotton swab. Additional WarmPak and BabyWrap can be purchased separately as necessary.

Lifecycle Disposal and warranty

1 year from the date of sale to the original purchaser, if used in accordance with operation manual of the product.

Manufacturer specified performance targets Designer / Manufacturer specified targets

The Embrace Warmer maintains a temperature of ~37⁰C for at least 4 hours. It is transportable, intuitive and sanitizable. The AccuTemp Heater delivers precision heating and prevents overheating of WarmPak. Can be used in settings with intermittent electricity.

Vetted performance Findings of manufacturer evaluations or independent testing centers

Manufacturer testing via clinical trials was conducted. A detailed description of the Clinical Performance of the Embrace Isothermal Mattress (KBW) was last verified in May 2012 by Stanford University. A non-inferiority trial was lead by the Department of Neonatology, St. John’s Medical College, (Bangalore, India) in 2015 and demonstrated that the warmer was non-inferior to the standard of care.

Testing organizations Independent lab, academic research centers, etc.

Clinical studies have been conducted at multiple hospitals in India, the most recent being Department of Neonatology, St. John’s Medical College (Bangalore, India) as well as at the Lucile Packard Children’s Hospital.

Safety Potential hazards / risks related to operation of this product

The warmer needs to be sanitized with a disinfecting cotton swab after every use. The Embrace infant warmer is not intended to be used in a home setting.

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

Unknown.

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

Nimbalkar, Somashekhar et al., Usage of EMBRACETM in Gujarat, India: Survey of Paediatricians, Adv Prev Med. 2014; 2014: 415301. Published online 2014 Oct 30. doi: 10.1155/2014/415301Treating neonatal hypothermia through a portable infant warmer: Dr. Sudhir Borgonha, MD, World Health Orgnanisation. ^not ^peer ^reviewed

The Embrace Infant Warmer for the Treatment of Hypothermia in Resource Limited Settings: Jeffrey McCarthy, PharmD, BCPP Biomedical Engineering, University of Rhode Island ^not ^peer ^reviewed

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

The organization has received its ISO certification, and will soon be applying for international regulatory approvals.

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

Routine safety testing, clinical trials and user surveying.

Other information

Embrace was awarded The Tech Awards’ Laureate Impact Award for 2015. The award honors past Tech Awards laureates who have demonstrated significant progress toward solving a global problem since winning the prize.

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