MiraCradle – Neonate Cooler

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MiraCradle™ – Neonate Cooler is an affordable cooling device which uses the advanced savE® Phase Change Material (PCM) technology to induce therapeutic hypothermia among newborns suffering from birth asphyxia. It is easy to use, safe, light weight, portable and gives the precise temperature control of 33-34°C for a period of 72 hours with minimal manual supervision and no requirement of constant electricity supply.
• Minimum Order Quantity (MOQ): 1 piece
• Seller Name: Pluss Advanced Technologies
• Seller Location: India
• Warranty Term: 2 years
• Regulatory Approval: CE, ISO 13485

Description

MiraCradle™ - Neonate Cooler uses the first of its kind – Form Stable Phase Change Material (PCM). PCMs are special thermal energy storage materials that store and release heat at a particular temperature. The thermal energy transfer occurs when the material changes phase from solid to liquid or liquid to solid. The savE® PCMs have been incorporated in a polymer matrix to ensure that when changing phase from solid to liquid PCMs retain its shape and form avoiding any risk of the PCM leaking from its encapsulation, thus making it completely safe for the user as well as the patient.

To ensure precise temperature control, MiraCradle™- Neonate Cooler uses a cascaded system of PCMs. Cascaded system is a patented technology that employs use of two or more form stabilized PCM mattresses with melt/freeze at different temperatures. By engineering the melting points, thicknesses, conductivities and placement of the involved layers, a “quasi-automated” cooling system is created, which, while being completely passive, behaves like a servo-automated cooling device.

Thousands of babies have been treated using MiraCradle™ – Neonate Cooler and it is currently present in over 400 hospitals across Asia and Africa.

Key Features

Design
MiraCradle™ is efficient – it gives precise temperature control. It is also economical, costing less than 1/5th of the price of electronic cooling devices and is designed to be long-lasting for repeat use.

Usability
Minimal manual supervision required. PCMs can be charged in a normal refrigerator.

Safety
This is a cooling system that does not require an electrical supply near the baby to function, making this a safe cooling option.

Specifications

Components of MiraCradle

  • Insulated Cradle: It is a rotomolded plastic structure which serves as a framework for placing all the other components of MiraCradle®- Neonate Cooler and also provides insulation to the PCM helping it last for longer hours
  • savE® FS-29: This forms the bottom layer of the MiraCradle®-Neonate cooler. Three units of savE®FS-29 PCM are placed at the bottom of Cradle. savE®FS-29 in solid state passively extracts heat from the neonate’s body which is at 37°C thereby inducing and sustaining hypothermia
  • savE® FS-21: This is the middle layer of the device. savE®FS-21 is used in conjunction with savE®FS-29 to quickly bring the temperature of the neonate down to 33°C. It is subsequently removed and savE® FS-29 takes over to sustain the temperature for longer hours
  • Conduction Mattress: The conduction mattress is a gel bed which provides a smooth surface for the baby to lie on and improves heat transfer between the baby and the PCM

Standard Accessories

Not applicable

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures

Brochure

Product Guide

Product Summary

User Manual

Neonatal HIE Pathophysiology Brochure

Therapeutic Hypothermia Risk Prevention Brochure

Therapeutic Hypothermia Mechanisms of Actions Brochure

Frequently Asked Questions

Regulatory Certificates

CE Certificate

ISO 13485 Certificate

Videos

FAQ

What is birth asphyxia/ HIE?

It is a medical condition in which there is deficiency of oxygen in the baby’s body resulting in slow neurological development.

What is the recommended therapy?

Therapeutic hypothermia is the recommended therapy where the baby is cooled to temperatures 33°C-33.5°C for 72 hours; cooling reduces metabolism and therefore reduces the oxygen demand by brain cells preventing cell death.

When is the therapy given?

Asphyxiated babies should be given hypothermia within 6 hrs of birth. Since baby could have been asphyxiated even before birth, it is advisable to give hypothermia as soon as the possible.

What is the intended use of MiraCradle® and how does it work?

MiraCradle® is used for inducing therapeutic hypothermia in babies suffering from birth asphyxia. It works by absorbing heat from the baby’s body to bring an equilibrium at desired temperature of 33.5°C for 72 hours. This is achieved using specifically engineered phase change materials (PCMs). The thermal energy storage technology and cascaded PCM design allow temperature to be maintained at a precise point throughout the course of therapy.

What disinfectants can be used for cleaning the device?

For decontamination (contamination not due to soiling) of MiraCradle®, liquid chemicals are used to kill non-spore forming bacteria on the device. Some commonly used disinfectants are Sodium Hypochlorite (Bleach), ethyl alcohol, isopropyl alcohol (70%), Alconox, Liquinox, Cidex (Glutaraldehyde).
However, we recommend ethyl alcohol, isopropyl alcohol or mixture of two, with minimum concentration of 70%. Labels and stickers used on MiraCradle® are tested for compatibility with alcohols only. Any deviation from the recommendation is at the own risk of user.

I have more specific questions, where can I find the answers?

For more specific questions regarding assembly, use, cleaning, maintenance and repair, please consult the Frequently Asked Questions document available for download.

Package Contents

  • 1x Insulated Cradle
  • 6x savE® FS – 29
  • 2x savE® FS – 21
  • 1x Conduction Mattress
  • Instruction Boards
  • 1x User Manual
  • 1x Registry for Therapeutic Hypothermia

Warranty

Warranty for each component of the MiraCradle is as follows:
Insulated Cradle – 1 year warranty
savE® FS – 29 – 2 year warranty
savE® FS – 21 – 2 year warranty
Conduction Mattress – 1 year warranty

Testimonials

MiraCradle™ – Neonate Cooler will be a good investment for the Neonatologists and Pediatricians dealing with cases of perinatal asphyxia. It is easy to use and affordable in a resource limited setting. It goes without saying that the cooling procedure should be undertaken with close monitoring of the baby. MiraCradle™ – Neonate Cooler is easy to use and the maintenance cost is almost nil.
– Dr. B.Vishnu Bhat
(Professor and Head, Department of Pediatrics, Division of Neonatology, JIPMER )

In India, asphyxia results in approximately quarter of the neonatal deaths and is a huge burden on neonatal morbidity and neurodevelopmental sequelae. Hypothermia is the only proven intervention to improve the neurodevelopmental outcomes; but because of the high cost of the currently available machines it is not available to most babies in the developing world. MiraCradle™ – Neonate Cooler is a significant low cost innovation to help such babies in this part of the world.

Dr. Sanjay Wazir MD, DM (Neonatology)
(Chief – Neonatology Medicine, Cloudnine Hospital, Gurgaon)

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