Technical Support - Technical Services
Winform - Technical Office -Via Garda, 6 - 30027 San Donà di Piave (Venice) - Italy
T. +39 0421 222026
F. +39 0421 225314
What is a medical device
All medical devices, in order to circulate within the European Community, must meet 2007/47/EC Directive 93/42/CE + 2007/47/CE gathering the prescriptions that the manufacturer must comply with the design, production, marketing and supervision of a medical device.
A medical device is any instrument, apparatus, appliance, material or other article, whether used alone or in combination (including the software necessary for proper operation) and intended by the manufacturer to be used on humans for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of a disease, diagnosis, monitoring, treatment, alleviation or compensation of an injury or handicap; study, replacement or modification of the anatomy or of a physiological process; intervention on conception, which product does not achieve its principal action, in or on the human body, which is intended, by pharmacological or immunological means nor through methabolic process, but whose function can be assisted by such means.
Depending on the intended use of the device, determined by the manufacturer, the Directive 93/42/EEC defines the acceptance criteria that will govern its design and marketing.
Typically, the medical device must meet the applicable technical rules in force in addition to specific rules depending on its intended use. Compliance is demonstrated through the successful completion of tests performed by authorized laboratories or by the manufacturer if in possession of credentials required by law.
The Directive 93/42/CEE highlights with particular emphasis the evaluation process of medical devoces. The medical device manufacturer must establish a documented system of risk analysis to identify any possible risks arising from the use of the device and to mitigate the effect through appropriate technical solutions. The risks identified are, for example, electrical safety, electromagnetic compatibility, ease of use, compatibility of materials used, the security of the software used.
The balance of evidence and the positive outcome of the risk analysis ensures that the medical device appears safe and accurate in handling data input and output to the patient to protect his health.
The certification procedure of a medical device ends with the editing of the technical product and, depending on the class of device, with its approval by a Notified Authorized Agency.
The indication of the Notified Agency which approved the technical file is shown in numerical format (eg 0051) under the symbol CE content of the serial label placed on each medical device. The devices that do not show under CE mark the number of Notified Agency are NOT medical devices.
The marketing of medical devices
The Directive 93/42/CE regulates the activities of market surveillance. The person responsible for marketing the medical device must establish a documented process for tracking and surveillance of medical devices . This procedure ensures that the device can be traced at any time. The importance of traceability is evident in the case where, for safety reasons, it must proceed, for example, for a return campaign. For medical devices, traceability also covers critical components, electrical or mechanical, contained within it. Any electrommedical device, in fact, prior to marketing, in addition to security and functionality tests, undergoes to accurate record of the serial numbers of major components. This procedure ensures maximum safety of those who come in contact with the equipment.
Installation, maintenance and control of the devices
In order to maintain unchanged its own performance and their safety ,medical equipment, once placed in the market, is necessary to make sure they are installed, mantained and verified by qualified personnel possessing special expertise in the area. In particular, the owner of a medical equipment park must establish a system of management of itself identifying a responsible in his center and providing a plan for periodic safety checks. Periodic inspections for the safety of electromedical equipment, provided by CEI EN 62353 rule, are within the context of preventive maintenance that is usually organized on two levels:
- 1st level maintenance
- 2nd level special maintenance
Must be performed by qualified personnel and only consists in the execution of all audits, inspections and tests for safety.
- Protective conductor resistence maintenance
- Measurement of leakage current to ground
- Measurement of leakage permanent currents and auxiliary current in the patient,
- Measurement of leakage current in the casing
- Check of insulation resistance
- Check of accompanying documentation (user manual and labels for recognition).
The technician who performs the special maintenance of 2nd level prepares a test report stating that the device complies with applicable regulations. A copy of this test report is given to the customer who could show it in case of inspection by the authorities (ASL, NAS, etc..).
The frequency of safety checks, as recommended by a guide IEC 62-122, is:
- once a year for equipment used in surgery rooms and similar
- once every two years for equipment used in all other types of premises (eg studies of physiotherapy)
After any repair has to be realized always a security check. It is faculty of a medical device manufacturer recommend a different periodicity.
Supply of Technical Service
Winform Srl technical assistance of is regulated by procedure P7.5-1 "production management and technical assistance" contained in the Company Quality Manual compiled in accordance with ISO 9001:2008. The technical work is carried out following a precise procedure that ensures maximum efficiency and transparency. Within 1 hour of receiving the indication of the supposed malfunctioning, our engineering department will contact the customer for an initial phone verification. In the event that it should be necessary a technical intervention, we provided at the opening of a practice with code CDD. After evaluation of the malfunctioning to the customer, we present an offer for the repair of the device. Once this offer is accepted we will proceed at the reparation in time in order to avoid compromission of customer operation. After reparation, the unit will be returned to the customer including periodic checks of safety so as prescribed by IEC 62353.
- Servicing and maintenance of electrical equipment in accordance with the requirements of rule CEI EN 62353
- Repair, reconditioning and extraordinary maintenance for easy repair and certification, even of a few units
- Electronic management of medical equipment through software: we are able to historicize all the operations on the equipment and fix the expiration of electrical safety checks, alerting the customer on which equipment such certification is needed, in accordance with the legislation in force
- Technical advice on purchases of new electromedical devices with technical and economic assessments
- Overall management of the devices owned, overhaul and testing, reconditioning of used devices
Technical Service Objectives
- Supply services at a quality level such to increase the level of customer satisfaction
- Simplified and personalized access to services by all customers large and small
- Reliability and punctuality of the intervention
- Reduction of inefficiency time due to "downtime" for failure or malfunction of electromedical devices
Winform Srl employs highly skilled technicians and constantly updated through special vocational courses, apart from knowledge acquired through years of experience on the field. Our technicians are able to intervene successfully on various types of medical equipment, being involved also on the design, manufacture and installation of EM equipment we produce.
Training of personnel
The complexity of the regulatory framework, as well as technological change, requires that the technicians who operate on medical devices are constantly updated. Winform technical staff undergoes to continuous training and upgrading activities at facilities qualified and recognized by the Ministry of Health. With regard to periodic safety inspections, our technicians have followed, with profit, the training course on CEI EN 62353 at the certified institute IMQ.
Menagement of Measuring Instruments
All instruments used by Winform Srl for testing activity and verification of electrical appliances are the latest generation and are subject to regular calibration tests at certified institutes of calibration (SIT). The management of the instrument calibration is regulated by P7.6-1 Rev02 "management tools" procedure contained in Winform quality manual.
All equipment produced by Winform are guaranteed for a period of 24 months from date of purchase to the exclusion of some parts/accessories as pregelled electrodes, cables, batteries, fibers, etc. The detailed specifications for each unit are indicated in the warranty certificate and on the manuals supplied with the units at moment of installation. The warranty is limited to defects on manufacture or on materials. The warranty does not cover damage caused by misapplication, neglect, accident, misuse, or modifications to the instrument realized by personnel not authorized from Winform srl.
The warranty doesn’t cover transport cost to and from our facilities.