MiraCradle an affordable solution for developing countries

Transcription

1 MiraCradle MiraCradle is an affordable cooling device 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 C for a period of 72 hours with minimal manual supervision.

2 02 MiraCradle Benefits MiraCradle an affordable solution for developing countries MiraCradle is a CE marked neonatal cooler that enables controlled cooling of newborn infants to support therapeutic hypothermia (TH) for birth asphyxia. The product has been developed with proprietary Phase Change Material (PCM) to maintain the temperature of the infant at C ( F) for the entire treatment duration of 72 hours, consistent with current best practices in treatment. Leveraging sophistication in material engineering, the product offers temperature specificity offered by current servo-devices less than one fifth of the cost. Safe and easy to use, easy to set up MiraCradle is free of electronics and needs no maintenance. The phase changing material can be charged in a normal refrigerator. After 6 8 hours of charging it is ready to use. The set up is easy and beside the normal temperature monitoring minimal supervision is required. Precise temperature control Two clinical studies have been published in India to show that the temperature stays stable for 72 hours. The first trial was conducted on 41 babies. The mean (±SD) temperature during the cooling phase was ± 0.39 C. Throughout the cooling phase, the target temperature range was maintained in 96.2% of the time. There was no temperature reading <32 C. Reference: Thomas et al. Phase changing material: an alternative method for cooling babies with hypoxic ischaemic encephalopathy. Neonatology. 2015;107(4): Epub 2015 Feb. PMID: The second trial was conducted on 103 babies and at 10 different hospitals. The median (IQR) of time taken to reach target temperature was 90 (45, 120) minutes. The mean (SD) deviation of temperature during cooling phase was 33.5 (0.39 C). Temperature readings were outside the target range in 10.8% (5.1% of the readings were <33 C and 5.7% were >34 C). Mean (SD) of rewarming was 0.28 (0.13) C per hour. Reference: Thomas et al. Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy A Multi-centric Study. Indian Pediatrics Epub 2017 Dec. PMID: Economical solution Less than 1/5th of the cost of the available electronic devices, long lasting material. No service and maintenance required.

3 MiraCradle 03 Clinical evidence Reference: Thomas et al. Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy A Multi-centric Study. Indian Pediatrics Epub 2017 Dec. PMID: Related Products Babytherm 8004/8010 MT Babytherm is an intensive care Infant Warming System intended as a therapeutic device providing warmth for premature and full term neonates. Not only does it provide babies with a unique thermal environment, but it also allows you to enjoy outstanding ease of access so you can give them the best possible care.

4 04 MiraCradle Related Products Resuscitaire D The Resuscitaire is the ideal device to have during labour and delivery procedures. It combines an effective warming therapy platform along with the components you need for clinical emergency and resuscitation.

5 MiraCradle 05 Technical Data Components of MiraCradle Neonate Cooler 1. Insulated Cradle Insulation Polyurethane Foam Insulation Thickness To allow for at least 72 hours of temperature maintenance of PCM Moulding Rotational Raw Material LDPE Color Pantone 3262C Size It is designed to fit in the bassinet measuring at least 66x47 cm of a regular radiant warmer Weight Approximately 4 kgs Temperature Ability To maintain temperature of PCM for 72 hours 2. Phase Change Materials (PCMs) PCMs are special thermal energy storage materials that store and release heat at a particular temperature. save FS-29 save FS-29 is a Phase Change Material which maintains the required temperature of 33 34⁰C Weight/unit 1.03 kgs Dimensions of each unit 180x330 mm No. of units in each MiraCradle 6 Storage Bottom part of refrigerator Temperature Indicator Colour based temperature indicator stuck on each save FS-29 pouch which indicates temperature between 23⁰C and 31⁰C. The temperature indicator changes color as the temperature changes Replace save FS29 PCM after three years from the date of first use or when found damaged, whichever is earlier. save FS-21 save FS-21 is a Phase Change Material which is used for rapid cooling Weight/unit 0.4 kgs Dimensions of each unit 270x330 mm No. of units in each MiraCradle 2 Storage Bottom part of refrigerator Replace save FS21 PCM after three years from the date of first use or when found damaged, whichever is earlier. 3. Conduction Mattress Weight/unit 1.2 kgs Dimension of one unit 540x330 mm Storage Room Temperature ISO certified company Product CE certified Replace Conduction Mattress after three years from the date of first use or when found damaged, whichever is earlier.

6 06 MiraCradle HQ PP Subject to modifications 2018 Drägerwerk AG & Co. KGaA Notes Not all products, features, or services are for sale in all countries. Mentioned Trademarks are only registered in certain countries and not necessarily in the country in which this material is released. Go to to find the current status. CORPORATE HEADQUARTERS REGION MIDDLE EAST, AFRICA REGION ASIA PACIFIC REPUBLIC OF SOUTH AFRICA Drägerwerk AG & Co. KGaA Moislinger Allee Lübeck, Germany Drägerwerk AG & Co. KGaA Branch Office P.O. Box Dubai, United Arab Emirates Tel Fax contactuae@draeger.com Draeger Singapore Pte. Ltd. 25 International Business Park #04-20/21 German Centre Singapore Tel Fax asia.pacific@draeger.com Dräger South Africa (Pty.) Ltd. P.O. Box 4676 Rivonia 2128 Tel Fax customercare_za@draeger.com Manufacturer: Pluss Advanced Technologies Pvt. Ltd. Plot no. 13 Sector 14 G. C. Bawal (Phase II) Bawal Haryana, India Locate your Regional Sales Representative at: SALES INTERNATIONAL INDIA Draeger India Pvt. Ltd. 10th Floor, Commerz II International Business Park Oberoi Garden City Off Western Express Highway Goregoan (East), Mumbai Tel Fax safetyindia@draeger.com