Google+ Scientific Evidence

Creating a unique product

There are a lot of things that make BabyKeeper a unique product. For the first time, all the properties that a cot mattress claims to have are backed by sound scientific basis. Four key elements make the difference between this and other cot mattresses on the market:

MEDICAL PRODUCT

What does it mean to be a medical product?

A medical product is something that is intended to be used on human beings for diagnosis, prevention, control, treatment or relief of any symptom or disease without being a medication.

There is a series of community guidelines regarding them being sold on the European market. As a result, to be sold, a health product must comply with CE marking regulations, authorized by health authorities, such as the Agencia Española de Medicamentos y Productos Santiarios (The Spanish Agency for Medical and Drug Products) (AEMPS).

What guarantees does a medical product give you?

The fact that BabyKeeper is a medical product is a double guarantee:

  • A guarantee of reliability: all the properties that the product claims to have, are scientifically based.
  • Quality Assurance: all components and processes involved in the manufacturing of the product go through rigorous quality controls and traceability.

BabyKeeper is an innovative product in the beds and bedding sector because it is the first to achieve the CE compliance marking, which certifies it as a medical product.

Abuse of the CE compliance marking

It is important to know that there are a number of products bearing the CE compliance marking and claiming medical-health properties, but which do not fall within the definition of a medical product or do not have a scientific basis. These products are considered to be fraudulent products and should be reported to the health authorities.

Any product claiming medical - health properties must have the CE compliance marking. The end user may check this through the corresponding certification authorities.

Product traceability

Throughout the manufacturing process, the BabyKeeper mattress is subject to strict traceability control. This tracking allows us to know what the components are for each manufactured unit and the quality controls performed on them, along with any other relevant information for the final guarantee on the product.

A computer system specifically used for this production process and an RFID system for this manufacturing process are standard procedures for performing product traceability.

It is important for the end user to register their product in the corresponding section of the babykeeper.es, website, as this way, their data is passed directly to the traceability system and they may be immediately informed of any incident that may affect their BabyKeeper mattress or any of its components.

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RECOGNIZED BY THE MEDICAL COMMUNITY

Research

After years of research, the impact of exogenous factors involved in the Sudden Infant Death Syndrome (SIDS) have been minimized. There are a series of objective measurable parameters that allow each of the properties claimed by BabyKeeper to be proved.

This research has been undertaken by prestigious professionals like Dr. Tomás Zamora (ESCI, European Sleep Care Institute) and Dr. Gonzalo Pin (Sleep Unit Unidad del Sueño Quirón Hospital Valencia), among others.

Present at the 5th World Congress on Sleep Medicine (WASM)

The findings of our studies and trials were presented at the 5th Congress on Sleep Medicine, held in Valencia during the month of September 2013.

The publication of the study, apart from the prestige implicit in this type of research, also includes the guarantee of having been supervised and approved by a committee of independent experts in the field, not involved in the investigation team.

BabyKeeper has been developed based on the conclusions of the study called Study of thermal properties, toxicity emissions and rebreathing avoidance as exogenous stressors of sudden infant dead syndrome in baby mattresses. Design recommendations.

Study conclusions

Las conclusiones del estudio establecen unas recomendaciones de diseño para la superficie de descanso del bebé como:

  • Maintaining the correct temperature, which should always be below a certain threshold.
  • Controlling the level of CO2 in the atmosphere surrounding the baby.
  • Maintaining the baby's environment sanitized and free from volatile toxic products, and thus, the need for both the product and all its components to be certified OEKO-TEX® Class I.
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OEKO-TEX® Class I and other certificates

OEKO-TEX® CLASS I

What is the Oeko-Tex® certificate?

The Oeko-TEX® certificate guarantees that no harmful substances have been used in making the product. Being Class I certifies that it complies with the most stringent control levels, which guarantees that the product can be in contact with even the most sensitive skins, like that of babies..

BabyKepeer®, and all its components, have the OEKO-TEX Class I certificate.

Abuse of the OEKO-TEX® certificate

The OEKO-TEX® label is used incorrectly and in an indiscriminate way in the bed and bedding sector. We can often find misuse of the certificate, guaranteeing compliance of one component, falsely generalizing about the whole product.

In order to protect the final consumer, BabyKeeper® invites you to check that any textile product that has the OEKO-TEX® label is duly registered and certified in the AITEX offices.

Certified OEKO-TEX BabyKeeper

For a product to strictly comply with this certificate it must have been subjected to a thorough control of both the final product and all elements in the composition.. In the case of BabyKeeper, all fibers and the final product are certified OEKO-TEX Class I.

Other certificates

Babykeeper® is the result of years of work and a high investment in R&D+i. ESCI (European Sleep Care Institute) and other professionals and partners made the creation of a unique product possible.

This product has been created according to a series of strict controls so that it can be certified as a healthcare product.

Sanitized

The Sanitized hygienic treatment protects the mattress from bacteria, mites and fungi. This is a very effective long-lasting treatment, providing comfort and welfare.

CE

The BabyKeeper® mattress has achieved a CE marking that certifies that it complies with the European Guidelines on this type of product.

HYG CEN

Guarantees that the materials are free of toxins and can be used in hospitals and medical centers.

DEVELOPED BY ESCI

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European Sleep Care Institute (ESCI)

BabyKeeper research and development has been carried out by the European Sleep Care Institute - ESCI (European Sleep Care Institute).

The aim of this Institute is the study and development of new technologies to improve sleep and rest quality. Prestigious institutions and professionals participate, whose aim is to provide the products of the rest market with the scientific and technical guarantees to support them.

Pediatric, child care and sleep area

Among the ESCI research areas is the pediatric, child care and sleep area, coordinated by Dr. Gonzalo Pin. This line generates knowledge and development opportunities related to risk reduction, such as the sudden infant death syndrome,childhood insomnia or apnea-hypopnea.

BabyKeeper® is the result of one of the developments in this area, making it the first cot mattress on the market with scientific backing, certified as a medical product with CE compliance marking.

Thus, ESCI aims to be the coordinator and communicator of scientific studies raising awareness regarding sleep as well as a collective regulatory body for the collective control of poor practice regarding rest and sleep.

Further information

For more information about the organization, its professionals, areas of research and development, you can visit the ESCI, European Sleep Care Institute website..

Professionals and partners

Dr. Gonzalo Pin

Coordinator of the Pediatrics and Sleep units at the Quirón Hospital in Valencia and member of the Spanish Association of Pediatricians.

Dr. Ephraim Bar-Yishay

Director of the Pulmonary Function laboratory at the Schneider Children’s Medical Center in Israel which has carried out investigations on CO2 rebreathing in infants.

IBV

The Biomechanics Institute of Valencia has carried out ergonomic and thermal comfort studies to help improve the characteristics of the mattress.

AITEX

Tests on material toxicity have been carried out at the Textile Industry Research Association.

CVIDA

The Caring for Quality of Life Association brings together companies and partners working towards improved health and wellbeing for individuals.

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