Catalog Clinical Engineering Division

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1 Catalog Clinical Engineering Division Trecentosessanta S.r.l. Unipersonal Society Scala Greca nº371/b Siracusa Italy Tel Fax rev.00

2 I0.00 CLINICAL ENGINEERING DIVISION I1.00 Clinical Engineering I1.01 Periodic checks of safety Periodic checks of electrical safety of equipment used in medical and clinical engineering to ensure the absolute safety of the patient in surgical and diagnostic evaluations, as well as of medical and paramedical, according to the CEI 62.5 (CEI EN Medical electrical equipment. Part 1: General requirements for safety) of D. L. n. 46, 24/02/97. The checks include the following activities: Visual inspection Data recording tab intervention: Control Number Inventory; Model; Control CE. Data recording check-list: check serial, control signals, power control type; control cable and power plug; control wrapping check the class, type of ownership and class risk control connection type (PC, other equipment); system audit, control certification. Instrumental Examination Using the tool Metron QA-90; Electrode Calibration; Setting QA-90 by type of equipment; Recording of data acquired from visual examination; Connection between QA-90 and the equipment to be examined; Detection time of QA-90 depends on the number of electrodes that the equipment has; Recording of data developed by QA-90; Check labels are applied on equipment. I1.02 Inventory of equipment and computerized management Inventory of electrical equipment and computerized management, including possible provision of software and hardware. Activities include: Data storage equipment Connection of QA-90 with a PC for data transfer to accommodate every single card; System and development of the checklists in electronic form attached sheet 's equipment. Data input software Search inventory number Check if belongs equipment examined Inserting the QA-90 Software Resetting alarm occurs. I1.03 Service overall management of maintenance Services and advice tailored to the individual buyer, according to the quality objectives set to offer a management service overall maintenance of electrical equipment, including services such as: Preventive maintenance Corrective Maintenance Special maintenance Assistance for acceptance testing Functional checks Quality Controls

3 Action on adaptation Management of contracts with third parties Spares Assessment on equipment disposals Advice on purchasing equipment Replacement equipment I1.04 Monitoring anesthetic gases Impartial monitoring can provide important elements of assessment, with possible solutions to the Security Supervisors.Among the significant characteristics of monitoring there is a correlation between quantitative data and events that occurred during the operative session. During monitoring, correlating all the information collected, are found possible because of high pollution and indicates the type of surgery to be performed to restore the conditions for healthy environments. I1.05 Monitoring microclimate Check up controls to have a complete and comprehensive state of the system: Due to the correlation of the measures of (performed with use of anemometer), differential pressure (measuring system with resolution 0.1 Pa), measuring air cleanliness (ISO 14644) and Recovery Time (UNI 12569). CIR is able to identify the possible causes of incorrect operation and to suggest interventions aimed at restoring full efficiency of the facilities. I1.06 Suitability of sterilization and washing systems Performance of Performance Qualification for equipment and process development or improvement, together with the customer, delll'organizzazione Service Sterilization preparation of operating instructions, procedures and user's guide. I1.07 Monitoring Through the implementation of a verification protocol, based on current legislation, CIR provides accurate assessment elements to those responsible for the hospital on the microbial loads present in the compartment air and surfaces. CIR is a healthcare facility for the personalization of profiles measured against specific requirements. Through a highly experienced microbiologists, perform analysis under the "at rest" to assess the quality of air in the room and monitor the effectiveness of protocols for cleaning and analysis under the "operational", the only ones that really allow to evaluate the correct operative behavior of the team. I2.00 Management assistance I2.01 Buying Consultancy CIR seeks partner to help identify the most appropriate solutions to customer needs, even if the plans for renewal and multi DRAFTING OF. I2.02 Process analysis and optimization of workflow Analysis of current processes and implementation of operational improvements that exploit the most of every resource of "Hospitals" (staff, infrastructure, technology). Process re-engineering is the answer to these needs and is also the necessary step to raise significantly the level of security, by virtue of the information acquired during the analysis phase in which they are observed more critical. I2.03 Support for ISO 9001 certification in health facilitie The international standard for quality management systems UNI EN ISO 9001 is an important reference for health care companies because, in addition to international recognition, compliance with ISO facilitates the legislative requirements laid down by national and regional legislation, from DPR 14 January 1997 in terms of licensed and accredited healthcare facility.

4 I2.04 Health approval and accreditation CIR able to lead the customer along the route for accreditation and meet the various needs of adaptation to the health legislation in recent years that has changed the logic of the relationship between health services and providers of health services and focused increasingly on quality of services rendered and benefits paid. I2.05 Risk management Analysis and risk management by automating, testing equipment, the development of adequate organization and management of specific training events. I3.00 Information and training I3.01 Information and training Design and conduct of operations information and training in clinical engineering, also customized to the client, basic and specialized, including teaching activities, tutoring and preparation of supporting materials. I3.02 Training and communication through satellite CIR provides response to this need with HCSAT,a new service for Training and communication at a distance. System HCSAT allows communication between audio and video facilities (health insurance, hospitals,university,etc..) Geographically dispersed in a secure and efficient. This is guaranteed by two-way satellite connectivity.

5

6 References Municipality of Noto (SR) 1 ALCOA Spa (VE) 1, 4, 7 Municipality of S. Agata of Militello (ME) 1 National Association of Manufacturers of Venice 4 Municipality of Portopalo (SR) 1 Venice Port Authority 8 Municipality of Syracuse (SR) 2, 3 Regional Center Services for Small and Medium Enterprises of Friuli Venezia Giulia (UD) 4, 9 Municipality of Melilli (SR) 2, 3 CFM Spa (SR) 1 Reclamation Consortium of Ragusa (RG) 1 CISMA Srl (CT) 6 Reclamation Consortium of Ispica (RG) 1 Cisma Ambiente Srl (CT) 6, 4 Reclamation Consortium of Acate (RG) 1 Cooperative Work New Tubital Scarl (VE) 1, 4 Reclamation Consortium of Vittoria (RG) 1 DEMONT Ambiente Srl (VE) 6 Reclamation Consortium of Lentini (SR) 1 DOW Poliuretani Italia Srl (VE) 6 Reclamation Consortium of Catania (CT) 1 ERG Nuove Centrali SPA (SR) 1, 6 Reclamation Consortium of Syracuse (SR) 1 Fintitan Srl (VE) 1, 4 Notary Study of Minniti Priolo and Syracuse Frada Group Srl (VE) 6 (SR) 1 Polidiater Center Noto (SR) 1, 2 E-laborando Group Srl (CT) 1 Polidiater Center - Syracuse (SR) 1, 2 Minerali Industriali Group Spa (VE) (LI) 7 Rizza Hospital Syracuse (SR) 2, 5 I & G Consulting and Engineering (SR) 7 Umberto I Hospital - Syracuse (SR) 2, 5 ILNOR Srl (VE) 2, 6 CIR Components s.p.a. Melilli (SR) 1, 4 ISAB Energy SPA (SR) 1 SI.TE.CO s.p.a. - Priolo (SR) 1, 4 ISAB Energy Services Srl (SR) 1, 9 GANCI s.r.l. Syracuse (SR) 1, 4 LA RO.VE.CO. Srl (VE) 1, 4, 7, 8 MULTISERVICES Roma 1, 4 Montefibre Spa (VE) 1 CAMPISI S.p.a. Syracuse 1, 4 PARADIVI SERVICES Srl (CT) 4 Minniti Notary Study Priolo and Syracuse Pilkington Italia Spa (VE) 2, 7, 9 (SR) 1 Coastal Services Srl (VE) 7 SEAV Srl (VE) 7 SGS Sacche Company Management Srl (VE) 4, 8 SIPI Spa (LI) 7 SIVE Formazione/Training Srl (VE) 1 Study Engineering Ing. Calafiore (SR) 8 Study Engineering Simoncello (VE) 6 Tecnocervices Srl (CT) 4 Notes 1-626, Health surveillance,technical Services,Formation, RSPP 2 - Microclimate,lighting surveys,electromagnetic,phonometric 3 Zoning and Noise Mapping 4 - Quality Management Systems, Environment and Safety 5 - Instrumental investigations 6 - VIA/VAS, AIA 7 - Plans Characterization and environmental surveys 8 Management plans and operational 9 Environmental communication

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