Integrated Resuscitation Systems

GE

Quick neonatal resuscitation delivery.

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

The Integrated Resuscitation Systems device is a quick, all-in-one system to quickly provide neonatal resuscitation. The device provides effective airway management, gentle ventilation, and pulse oximetry. The device is consists of a bag and mask and a T-piece design.

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

European Union

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

General Electric Healthcare Systems

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

4070 USD

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

Ohmeda 3300 Infant Warmer System, Air-Shields C450 Incubator

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)

Newborn children

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

Unknown

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

Patented

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

Interested users should directly contact the manufacturer for details.

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

Over 25,000 devices have been distributed to date.

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

Consumables

List or none.

T piece

Power supply type

Continuous, Recharging only, None, Other

Continuous power from a stable outlet

Indispensable equipment for function

Maintenance or calibration required by user at time of use? (Y/N)

Display Type

Analog

Gas Flow Range (L/min)

0-15

Pressure Range (cm H2O)

-10 - 80

Patient population (specify)

Neonatal

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

The product can take a hospital pipeline or a cylinder as gas input. The product features a gas blender that allows the output oxygen concentration to vary between 21-100% O₂. The device can largely be operated with one hand. The airway management features a fully integrated suction and the positive pressure delivery can be monitored during delivery. The system can be mounted on a roll stand and a GCX.

Product dimensions are: 13.4 x 9.7 x 9.8 in. The product weighs 19.8 lbs with Blender. More detailed product specifications can be found here.

Product schematics Design and assembly illustrations

Unavailable

Technical support Technical support provided by

Provided by the manufacturer.

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

The T-piece is a single use item and needs replacement between patients, which can be purchased from the designer. Cylinders for oxygen supply require replacement when their levels are low.

Lifecycle Disposal and warranty

5+ years

Manufacturer specified performance targets Designer / Manufacturer specified targets

Manufacturer specified performance targets include: quick, integrated features, one-handed ergonomic operation, and easy to use.

Vetted performance Findings of manufacturer evaluations or independent testing centers

The system has undergone integration, performance, safety, usability, and biocompatibility testing according to U.S FDA guidelines.

Testing organizations Independent lab, academic research centers, etc.

Recognized and supported by the current International Liaison Committee on Resuscitation (ILCOR).

Safety Potential hazards / risks related to operation of this product

A PIP safety valve is used is used in the system for easy one hand activation by pressing the PIP knob release.

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

Compatible with Panda and Giraffe Warmers. GE (the designer) offers system holding kits such as a GCX arm and roll stand, as well as a T piece disposable circuit for purchase.

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

M. E. Cavicchiolo et al., 2018, Decision making and situational awareness in neonatal resuscitation in low resource settings, Resuscitation, vol. 134, pp. 41–48.

S. K. Berkelhamer, B. D. Kamath-Rayne, and S. Niermeyer, 2016, Neonatal Resuscitation in Low-Resource Settings, Clinics in Perinatology, vol. 43, no. 3, pp. 573–591.

S. N. Wall et al., 2009, Neonatal resuscitation in low-resource settings: What, who, and how to overcome challenges to scale up?, in International Journal of Gynecology and Obstetrics, vol. 107, pp. S47–S64.

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

The system was designed according to the American Academy of Pediatrics’ (AAP) latest Neonatal Resuscitation Program Guidelines. The product is in compliance with the U.S. FDA.

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

The product was evaluated in compliance with the U.S. FDA. The following quality assurance measures were evaluated: risk analysis, testing on unit level (module verification), integration testing (system verification), performance testing (verification), safety testing, usability testing, and biocompatibility testing.

Other information

The Giraffe and Panda i-Res Infant Warmers, complementary systems to the Integrated Resuscitation Systems, underwent a Class I FDA Recall in 2019 for certain products issued between 2008-2019 due to complaints related to bedside panels/latches.

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Snapshot

Product description Brand name and product description

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

European Union

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

General Electric Healthcare Systems

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

4070 USD

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

Ohmeda 3300 Infant Warmer System, Air-Shields C450 Incubator

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)

Newborn children

Manufacturing & delivery

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

Unknown

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

Patented

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

Interested users should directly contact the manufacturer for details.

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

Over 25,000 devices have been distributed to date.

Performance & use

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

Consumables

List or none.

T piece

Power supply type

Continuous, Recharging only, None, Other

Continuous power from a stable outlet

Indispensable equipment for function

Maintenance or calibration required by user at time of use? (Y/N)

Display Type

Analog

Gas Flow Range (L/min)

0-15

Pressure Range (cm H2O)

-10 - 80

Patient population (specify)

Neonatal

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

Product dimensions are: 13.4 x 9.7 x 9.8 in. The product weighs 19.8 lbs with Blender. More detailed product specifications can be found here.

Product schematics Design and assembly illustrations

Unavailable

Technical support Technical support provided by

Provided by the manufacturer.

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

The T-piece is a single use item and needs replacement between patients, which can be purchased from the designer. Cylinders for oxygen supply require replacement when their levels are low.

Lifecycle Disposal and warranty

5+ years

Manufacturer specified performance targets Designer / Manufacturer specified targets

Manufacturer specified performance targets include: quick, integrated features, one-handed ergonomic operation, and easy to use.

Vetted performance Findings of manufacturer evaluations or independent testing centers

The system has undergone integration, performance, safety, usability, and biocompatibility testing according to U.S FDA guidelines.

Testing organizations Independent lab, academic research centers, etc.

Recognized and supported by the current International Liaison Committee on Resuscitation (ILCOR).

Safety Potential hazards / risks related to operation of this product

A PIP safety valve is used is used in the system for easy one hand activation by pressing the PIP knob release.

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

Compatible with Panda and Giraffe Warmers. GE (the designer) offers system holding kits such as a GCX arm and roll stand, as well as a T piece disposable circuit for purchase.

Research & standards

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

M. E. Cavicchiolo et al., 2018, Decision making and situational awareness in neonatal resuscitation in low resource settings, Resuscitation, vol. 134, pp. 41–48.

S. K. Berkelhamer, B. D. Kamath-Rayne, and S. Niermeyer, 2016, Neonatal Resuscitation in Low-Resource Settings, Clinics in Perinatology, vol. 43, no. 3, pp. 573–591.

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

The system was designed according to the American Academy of Pediatrics’ (AAP) latest Neonatal Resuscitation Program Guidelines. The product is in compliance with the U.S. FDA.

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

Other information

Feedback

In context photographs (0)

You can use the form below to contribute a photo of this product.

In context files & documents (0)

Feedback from users, customers & distributors

Please let us know your experience in using this product through comments below.

Solutions Library

Sign In

To search & compare 1000+ essential technologies

PremieBreathe

Mirola Rescue FIDO

Augmented Infant Resuscitator (AIR)

Oxygen Reservoir System

Neovent

FREO2-SIPHON

Diamedica Helix Portable Ventilator

MTTS Dolphin CPAP

Diamedica Baby CPAP

Integrated Resuscitation Systems

GE

In context photographs (0)

In context files & documents (0)

Feedback from users, customers & distributors