Quality and Excellence

Transcription

1 Quality and Excellence

2 What is Accel-Heal? Accel-Heal is a compact (7cm x 4cm x 2cm), certified and patented, battery powered electroceutical treatment device (Class IIA) designed to improve and accelerate healing rates in patients with complex wounds. What is an electroceutical? Practically all of the body s organs and functions are regulated through neural circuits communicating via electrical impulses, it should therefore be possible to interpret the electrical language of disease from the level of gene expression upwards. By extension, it is then possible to stimulate, inhibit or change a malfunctioning pathway in order to correct the defect. The new term for this innovative area of medicine is electroceutical. Unlike the universal term previously used, e-stim, electroceutical implies a more accurately targeted application more akin to its pharmaceutical equivalent. Synapse Accel-Heal s parent company is leading the way in this area of medicine with the development of a clinically relevant electroceutical with its patented Synapse Sequence found within the compact Class IIA device Accel-Heal. How do I know that Accel-Heal is safe to use? Accel-Heal is designed and manufactured to conform with the highest standards of quality and safety. It adheres to the quality standards dictated by the International Organization for Standardization (ISO), Medical Devices Directive, Medical Device Classification and CE marking.

3 Why should I use Accel-Heal? Developed and designed with ease of clinical application and patient comfort in mind, Accel-Heal used along standard dressings without a need for a change in the treatment plan, improves treatment outcomes and quality of life for patients with complex wounds. Independent clinical trials demonstrated that Accel-Heal made a significant reduction to wound size, exudate levels and pain in 95% of patients, with 38% achieving full closure. Accel-Heal improves and accelerates healing rates, while significantly contributing to cost savings. 15% reduction ( 6.2 million) in costs to the NHS, over a five moth period, demonstrated via independent health economics analysis (cost per QALY of minus 7,696) and a 27% reduction in nurse visits. ISO explained ISO is an independent organisation that creates standards for all kinds of industries. It is mainly targeted towards the European market although some other countries also adopt ISO standards. What is ISO 9001? ISO 9001 is a general set of quality system standards for companies. If a company complies with the ISO 9001 standard, this means that the company is organised in such a way as to obtain a high level of customer satisfaction, and to continually improve this organisation. Compliance with the standard is certified by an external accreditation body. Synapse Electroceutical Ltd the home of Accel-Heal is ISO 9001 accredited, ensuring highest standards of customer satisfaction and commitment to continued improvement.

4 What is ISO 13485? ISO is based on ISO 9001, but with specific adaptations for companies that manufacture medical devices. These adaptations relate to: making sure that patient safety is kept in mind during all phases of the product design making sure that the product complies with regional or national laws concerning medical devices rather than continually improve (see ISO 9001), this standard asks to maintain the level of efficiency within the organisation. Synapse Electroceutical Ltd the home of Accel-Heal is accredited with ISO ensuring patient safety, compliance with regional and national laws and maintaining standards of efficiency within the organisation. What is MDD 93/42/EEC? The European Union has created the Medical Device Directive (MDD) to regulate the market in the medical device sector. The MDD stipulates all essential requirements that must be met by the device when it is put on the European market. The conformity of the product with the MDD requirements is assessed by an external accreditation body. Accel-Heal meets and complies with all essential requirement stipulated by the MDD.

5 What does a CE-mark mean? A CE (Conformité Européenne) mark indicates that a product complies with the European Directive that applies to it. Medical devices, in order to be granted a CE mark must meet all essential requirements of the MDD. Accel-Heal is marked with a CE mark as it meets and complies with the MDD essential requirements and carries CE 0120 reference number. Medical Device Classification and the meaning of a Class IIA classification If a product is a medical device it should be given a classification based on the risk it poses to the patient or end user. Accel-Heal is a Class IIA device as it is an active therapeutic device intended to administer or exchange energy to/from the human body in a non hazardous way. Science behind Accel-Heal Neural circuits communicating via electrical impulses regulate many physiological functions, therefore it is possible to interpret the electrical language of health and disease from the level of gene expression upwards. It is now possible to inhibit or change a malfunctioning electrical pathway in order to correct a potential defect. Accel-Heal is a non invasive, compact Class IIA medical device which uses the patented Synapse Sequence programmed to deliver a specific series of electric energy interactions through the skin to manipulate gene expression to modify specific physiological functions in dermal tissue.

6 Find out more To find out more about Accel-Heal visit To find out more about Synapse The home of Accel-Heal visit Purchase Accel-Heal Please contact us at or call us on NHS Supply Chain Accel-Heal is available via NHS Supply Chain and SBS Services, Product Code: K560-6 Arrange an educational visit To arrange a non promotional visit to find out more about Accel-Heal, us on info@accelheal.com or call us on Synapse Electroceutical Ltd 1 Churchill Court, Hortons Way, Westerham, Kent, TN16 1BT t: e:info@synapseec.com Company reg.no: