MiraCradle

Market Suggested Retail Price

$4,000.00

Target Users (Target Impact Group)

Distributors / Implementing Organizations

The product is currently being distributed worldwide through the VIAGlobalHealth, Colmed and Dräger websites.

Manufacturing/Building Method

MiraCradle's materials are manufactured and mass produced by Pluss Polymers.

Intellectural Property Type

Patent Protected

User Provision Model

MiraCradle can be purchased online through multiple platforms such as VIAGlobalHealth, Dräger and Colmed.

Distributions to Date Status

MiraCradle is present in 165 hospitals across the globe as of August 2021.

Design Specifications

The MiraCradle operates with the use of phase change materials (PCM) designed to melt/freeze at the temperatures which would ensure a temperature regulation of the infant between 33 and 34°C for up to 72 hours. The PCM absorbs heat from the baby thereby cooling the baby. The device uses two PCMs which have a melting/freezing temperature of 29°C and 21°C and an insulated cradle to place these PCMs. A gel bed is placed above the PCMs to give a comfortable surface for the baby Operational requirements as noted in the 2014 WHO Compendium of Innovative Health Technologies for Low-Resource Settings: Pre-cool the PCMs FS-29 and FS-21 in a refrigerator for a period of 6-8 hours. Place the 3 pre-cooled PCM FS-29 slabs in the insulated cradle. On top, place 2 slabs of PCM FS-21. Place the gel bed above the PCMs. Place the complete set in the bassinet of a standard infant warmer. Place the baby over the gel bed. Use a rectal probe to measure the temperature continuously. If the temperature decrease below 33°C, use a warmer to increase the temperature. Device Weight: 13 kg; Dimensions: 620 mm x 460 mm

Technical Support

MiraCradle's website section on maintenance and operation suggests that the product is easy to use and should require zero maintenance. However, they also provide a detailed user manual, training video, and two guides for assembly and temperature monitoring, along with contact information for any queries.

Replacement Components

Instructions in the user manual suggest as follows: Replace savE FS-29 PCM and savE FS-21 PCM after they have individually been used 500 times. Do not use either after their expiry dates under any circumstances. Replace Conduction Mattress one year from the date of first use. Do not use Conduction Mattress after expiry date under any circumstances. Replace the temperature indicator on savE FS-29 one year from the date of first use.

Lifecycle

3 years, as listed in the 2014 World Health Organization's Compendium of Innovative Health Technologies for Low-Resource Settings.

Manufacturer Specified Performance Parameters

Non-electric and able to maintain temp of 33.5 °C for a period of 72 hours^{Interview with representative}

Vetted Performance Status

Neonatologist Niranjan Thomas first began experimenting with and testing gel packs as a cooling treatment nearly a decade ago (relative to Spring 2016) at the Christian Medical College in Vellore, India. The MiraCradle team also beta-tested the product with hospitals in India. A randomised controlled trial was performed in India, finding that MiraCradle's therapeutic induced hypothermia reduces brain injury rates at the NICU.  

Safety

Safety instructions are listed in the user manual , such as reviewing the manual and warning/caution labels carefully before use, avoidance of use of damaged contents and contact for replacement, and storage of parts as per instructions. Additionally, ensure that sufficient training is required and that parts are sanitized before use.

Complementary Technical Systems

A domestic refrigerator is required for freezing the PCM; the temperature of NICU should be maintained above 25°C. Also requires equipment for monitoring the vital parameters of the newborn during treatment (ex. rectal probe)

Academic Research and References

Compliance with regulations

CE certification and ISO 13485

Other Information

The company obtained a partnership with Fanem Medical Devices in April, 2021, in order to expand its distribution capacity throughout India.