Integrated Resuscitation Systems

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 Users (Target Impact Group)

Distributors / Implementing Organizations

General Electric Healthcare Systems

Manufacturing/Building Method

Unknown

Intellectural Property Type

Patent Protected

User Provision Model

Interested users should directly contact the manufacturer for details.

Distributions to Date Status

Over 25,000 devices have been distributed to date.

Design Specifications

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.

Technical Support

Provided by the manufacturer.

Replacement Components

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

5+ years

Manufacturer Specified Performance Parameters

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

Vetted Performance Status

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

Safety

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

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 and References

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

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.

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.