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Ways of Optimising Medical Equipment

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MAGAZINE FOR ELECTRICAL SAFETY 2 10 Highest safety specifications New office tower for Süddeutscher Verlag in Munich Page 23 Remote diagnosis thanks to reliable technology How residual current monitoring
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MAGAZINE FOR ELECTRICAL SAFETY 2 10 Highest safety specifications New office tower for Süddeutscher Verlag in Munich Page 23 Remote diagnosis thanks to reliable technology How residual current monitoring is protecting highly sensitive remote diagnostic technology in the HELIOS St. Elisabeth Clinic Page 26 Ways of Optimising Medical Equipment Future technology is designed for safety Student design competition for all-electric racing cars with Bender technology Page 28 editorial Dear Reader, To coincide with MEDICA we have focused on the topic of hospital technology in this Monitor issue. Hospital technology has been one of Bender's supreme disciplines for decades. Why? Because that is where quality and reliability are absolutely vital. A power failure in an operating theatre or intensive care unit can have fatal consequences for the patient. It is essential to avoid excess current as well though: minimal leakage currents that you would have no hesitation to neglect in an industrial application have to be reliably measured and avoided in an operating theatre because they constitute a hazard to the patient. Bender is an innovation leader for hospital technology, e.g. in the so-called Group 2 applications such as intensive care units and operating theatres, in preventive monitoring for earthed power systems, so-called Residual Current Monitoring or also in safe switchover between the preferred cable and the redundant cable in order to ensure a reliable power supply. In addition to components for hospital solutions the Bender Group also offers all-in solutions ranging from engineering and system construction, including visualisation, to commissioning and service. Customised systems and all-in solutions are planned and implemented by bender systembau in the IEC-world and Bender Isotrol in the NFPA-world. Following intensive development activities Bender is making a number of new hospital market products available in the near future, e.g. a new hospital ISOMETER to IEC (isomed427p), a new hospital ISOMETER to NFPA (LIM2010), a new insulation fault locator (EDS151), a new range of compact, high-safety transfer switching devices (ATiCS) and a new mobile safety tester (UNIMET 400ST), which was optimised, inter alia, for regular testing of hospital beds. Enjoy the reading! Yours Dirk Pieler CEO IMPRINT Publisher: Dipl.- Ing. W. BENDER GmbH & Co. KG. Londorfer Straße Gruenberg /Germany Fon: Fax: Editorial staff: Marita Schwarz-Bierbach Anne Katrin Römer Graphic & layout: Natascha Schäfer Copy: Timothy Hörl Photos: Bender Archiv, S!Designment, esb-archiv, Helios-Kliniken Bilddatenbank, Helios St. Elisabeth Klinik Hünfeld, HT Labor + Hospitaltechnik AG, FSG Harald Almonat, FSG Ole Kröger, FSG Klaus Bergmann, FSG Ingo Reichmann, FSG Kimmo Hirvonen, GreenTeam Uni Stuttgart Print: Druckhaus Bechstein, Wetzlar, Germany 02 MONITOR 2/2010 content Ways of Optimising Medical Equipment 04 Certification: A Look Behind the Scenes 10 Approval of Bender Equipment for the North American Market INNOVATIVE PRODUCTS AC/DC sensitive residual current monitoring 12 with pre-warning function From the idea to the product 13 Development of the Bender changeover module ATiCS for the medical sector in accordance to SIL 2 shown in 9 steps Electrical safety in photovoltaic systems 18 achieved by IT system with A-ISOMETER iso-pv and insulation fault locator EDS SolarBox BISI (ENS) 20 Electrical safety for grid-connected PV generation systems UNIMET 400ST 22 the lightweight unit for mobile applications TECHNICAL APPLICATION Highest safety specifications 23 New offi ce tower for Süddeutscher Verlag in Munich Remote diagnosis thanks to reliable technology 26 How residual current monitoring is protecting highly sensitive remote diagnostic technology in the HELIOS St. Elisabeth Clinic Future technology is designed for safety 28 Student design competition for all-electric racing cars with Bender technology COSTUMER PORTRAIT HT LABOR + HOSPITALTECHNIK AG 32 Exclusive interview with Dipl.-Ing. Dieter Hackl 34 Head of division: Research, Design and Testing (T-RDT) of the Dipl.-Ing. W. Bender GmbH & Co. KG Ways of Optimising Medical Equipment Page 04 Items of medical equipment in hospitals are not only means of production but also tools. What is contemporary management like in this sector? The orientation of clinics has seen an about-turn, not least on account of the reformed accounting system... SolarBox BISI (ENS) Electrical safety for grid-connected PV generation systems Page 20 More and more consumers that generate electricity for their own needs are feeding electricity to the public lowvoltage grid by means of cogeneration plants, wind turbine systems, hydroelectric systems and photovoltaic systems and the number is rising rapidly... HT LABOR + HOSPITALTECHNIK AG Page 32 is one of the largest project planning and manufacturing companies in the world for room systems and their individual components in the laboratory and hospital construction sector. Our employees advise national and international customers and partners worldwide... 2/2010 MONITOR 03 FEATURE 04 MONITOR 2/2010 Items of medical equipment in hospitals are not only means of production but also tools. What is contemporary management like in this sector? The orientation of clinics has seen an about-turn, not least on account of the reformed accounting system nowadays the focus is on keeping the patient's stay short. However, nothing has changed in the maintenance of medical equipment. Ways of Optimising Medical Equipment Even Albert Einstein once said: The purest form of madness is to leave everything as it is and still hope that something will change. Are minimised costs and optimised device availability just a dream? Doesn't the change in use also call for an adaptation in maintenance? 2/2010 MONITOR 05 FEATURE If we take a look at maintenance today, in clinics we often see a long-established organisation which, in one department or another, outsources tasks to external service providers en bloc . With the latter, maintenance agreements are made which are renewed every year, and the price, service and stock of equipment are adjusted automatically without the clinic conducting any analysis. Administration is the order of the day and not control. This is where it is possible to achieve potential cost savings, at the same time retaining optimisation and quality enhancement. Requirements for a modern medical technical services department: Assurance of the device safety required Assurance of the device availability required Compliance with laws, ordinances and other provisions Documentation (Co-)attendance to IT interfaces and networks Maintenance planning Budget planning Transparent cost management Support with (re-)investment planning Procurement consultancy. Situation analysis Before optimisation can commence, important general conditions have to be clarifi ed: Distinct task description by clinic management Defi nition of the departments and contact persons involved Interfaces with other departments Project duration Budget available Responsibilities and decision-making competencies. It starts with a situation analysis, an investigation into the various in-house processes. This particularly applies to the following topics: Procurement and decommissioning Fault reporting system Maintenance: inspection, care, servicing and repair (Re-)investment planning Staffi ng and staff training Task allocation (familiarisation/training, purchasing, maintenance, documentation). When conducting the analysis it is important to establish whether there have been any changes and to what extent. Have specialised departments been closed or has their orientation changed? Have there been any staff changes in the departments responsible for facility services or medical equipment and have there been any changes in the stock of equipment or its age structure? Have any functional areas been rehabilitated or rebuilt? This is followed by a summary of the annual staff costs (medical equipment), spare parts and consumables (in-house technical services), purchases of accessories and small items of equipment (patient cables, blood pressure monitors, patient thermometers, etc.), repair costs (labour and materials shown separately), servicing costs (fi xed and fl exible), repair exchange costs (e.g. rigid endoscopes) and a comparison over a period of three to fi ve years. A graph of cost characteristics helps to recognise fl uctuations sooner. Another important question is whether costs have been booked or whether comparability is impaired by other factors. Based on generic ratios an initial evaluation can be performed with benchmarks. In this context, special importance must be attributed to actual comparability. The potential sources of error are: value added tax, different interfaces between facility services and medical equipment, with/without consumables, with/without vacuum items (X-ray tubes), with/without staff costs, and plenty more besides. In any evaluation of the stock of equipment it is absolutely essential to check not only the age and technical condition of the equipment but also its workload and how up-todate it is in technical terms. Planning When the current situation has been analysed, the actual requirement is established taking into account the future orientation of the various departments of a clinic. For example, equipment workload and the need for equipment availability can change as a result of an extension or reduction (e.g. the introduction of medical care centres or outpatient surgery). Declining workloads in the case of older equipment and forgotten treasures must be questioned critically. 06 MONITOR 2/2010 FEATURE The fi rst step has been taken. It is followed by an overview of medical equipment maintenance: what necessary activities can be scheduled? What type, scope and frequency? Taking a broader outlook, which of these measures can be taken in-house as regards technical issues? Which ones defi nitely have to be outsourced regardless of current capacity? How can in-house services be increased? What is required for this? This question should be asked before the cost-benefi t analysis is conducted, initially regardless of any view to the budget. Service agreements All fi xed service agreements must be checked thoroughly. That includes a review of the individual partners who have been commissioned for many years. Importan aspects: Is the stock of equipment still the subject of the agreement? Scope, service/inspection intervals, workload? What other services have been contractually agreed? Which of those services have been used in the past? (scope, frequency, costs) Are the items of equipment being used to the extent planned? (number of scans, etc.) When was the price last negotiated for this agreement? Term of agreement? Period of notice? Alternative contractors - in-house service feasible? Risk assessment what would happen if? Caution! Termination of an old agreement is not always the best option because particularly full service agreements can sometimes be extremely customer-friendly after a number of years. A price-cutter often fails to deliver the quality required. Some customers have paid the price for their cheap is cool attitude. Hence supplier assessment and risk management! Inspection and testing Compiling an annual overview of all inspections and tests is another step in planning. In an analysis of in-house services and outside services it is necessary to address the issue of opportunities offered by insourcing. By bringing deadlines forward it is possible to achieve a linearisation of work volume. For example, longer intervals may be possible for the BGV A3 accident prevention testing of electrical equipment or consistency testing. When planning resources an annual overview is compiled, taking into account holiday periods, availability of test instruments, and device workloads. It is important to take into consideration possible absences due to training or illness. Early involvement of the relevant employees ensures a high degree of planning certainty. Technicians and equipment offi cers can provide important information when the overview is being compiled. It is more economical to purchase services at low cost when one can only provide them at high cost oneself. Unscheduled activities Depending on the status of past documentation already compiled the situation analysis indicates how much time the in-house employees have taken for unscheduled activities, i.e. fi rst-line service and repairs. If no times have been recorded, the time taken can be inferred from the number of faults processed. The optimisation potential is particularly found in process optimisation. Automated fault acceptance in the EDP system creates free capacity on the technical side and always indicates the current processing status to the user side. Work can be allocated according to priority and the technical competence of the various technicians. If one considers how much time is lost on account of telephone calls, pagers and calling back, the unexploited potential is recognised. A 2/2010 MONITOR 07 FEATURE well-organised system of fault management saves resources, saves money and is easier on the nerves of technicians and users. The sum total of cost-saving potentials must be documented and discussed in the team of people involved. With a SWOT analysis it is possible to present strengths, weaknesses, opportunities and risks in a clearly arranged manner. Using an Ishikawa diagram, cause and effect can also be highlighted within the team. When the priorities have been specifi ed, the objectives and measures are defi ned and formulated in accordance with the SMART principle: Specifi c, Measurable, Ambitious, Realistic, Timed. A few ratios are established which provide information about the degree of fulfi lment and success of the measures defi ned. Implementation Planning without systematic implementation is of no value. When planning has been established, communication with the relevant people responsible in the various departments constitutes an important step on the road to success. Inform the department managers about your project and keep in touch. Regular monitoring of deadlines and the communicating of milestone targets already achieved are important motivation factors. Service agreements The risk assessment, which includes scrutinising device age and condition, failure probability and the resulting effects, period of use and pattern of use, is the fi rst step. After that, notice is served to terminate the agreements that will defi nitely no longer be continued. All the other ones are often negotiated without the need for termination and if one is pushed for time, it is advisable to suspend the period of notice once. Notice of termination, however, should always be the last step. Comparison offers from competitors are used to objectively compare services and costs and evaluate the quality of work according to predefi ned criteria. An evaluation matrix and risk assessment provide the decision-making basis for selecting the right partner. Checklists can be grouped in a systematic general overview in which the pattern of use and frequency of use are included. Scheduled activities Openly communicated maintenance planning creates transparency and clarity. If changes occur on account of unforeseeable events, it is possible to respond in good time. If scheduled activities are outsourced, the scope, period of service and costs must be clearly defi ned. In an agreement only the devices actually tested or serviced are remunerated. Minor repairs (up to a defi ned value limit per device) can also be commissioned up to a certain percentage, thus increasing the level of availability and reducing any additional expenditure. However, here too the absolute cost limit should be specifi ed. Unscheduled activities All faults must arrive at a central location in the (medical) technical services department. Information paths where work does not have to be interrupted should be given priority. Automated systems not only have the advantage of a reduction in downtime input, information and documentation are also accomplished immediately. The technical services department thus controls the fault acceptance times and processing. Users are simultaneously informed of the current status in the same way. This avoids the need for enquiries about the scheduled date of completion. Offi cial instructions on Medical Equipment provide an opportunity to describe procedures and fault-reporting channels. Before a service contractor is commissioned, any sources of error should be ruled out by in-house technicians. For example, minor defects such as 08 MONITOR 2/2010 FEATURE operating errors or faulty fuses can be quickly remedied by staff themselves without the need for expensive servicing jobs. This cuts costs and simultaneously increases device availability. Anyone who accompanies a servicing job performed by an external contractor with an in-house employee can often remedy the fault himself in future, as a result of watching and asking questions. Subsequent documentation in the device maintenance software can provide useful hints in the event of later faults and may draw attention to guarantees. In addition to cost and availability optimisation the reputation of the in-house technical services department is increased. Customer satisfaction is also boosted in the departments. Purchasing and storage Some technical services departments have ranges of spare parts and old treasures, do some stocktaking and sort out liberally. Items for which the matching device no longer exists at your facility are of no value. Sometimes it is possible to sell such parts to other clinics. Empty your storerooms and only order quantities you will actually consume. A search for suppliers who offer a large number of small items on reasonable terms is more profi table than ordering them from a super discount store that makes a surcharge for small quantities and invoices mailing charges. Agreeing annual call-off quantities or total volumes consolidates purchasing, reduces expenses and ultimately cuts costs. CONCLUSION To summarise, it must be stated that it is absolutely essential that changes in the pattern of using equipment and systems are followed by professional, commercially oriented device management. In this context a structured stock of equipment in line with the service portfolio of the clinic is just as important as organisational optimisation of maintenance and management procedures regarding technical devices. This usually means substantial changes in terms of equipment and procedures. This process can only be implemented effectively with external support. Good, practice-oriented consultants recognise defi cits in proven structures and can implement substantial changes more effi ciently owing to their experience. Objective assessment of the current situation and supervision during the fi rst stages of implementation cannot be handled by internal resources. In addition, the external helps to present and implement unpopular decisions. Anyone who endeavours to save money on project and resource planning should consider whether he wants to change anything at all. Reporting Do good and talk about it. The ratios defi ned in planning are regularly monitored in current reports within the project team without delay and appropriate measures are initiated. These are recorded on a continuous action plan, scheduled and delegated with clear responsibility. At relatively long intervals (quarterly or biannually) senior management is involved in developments. In this context it is useful to have a standardised, brief report presentation. A comparison between the situation analysis and current fi gures brings new fi ndings to light for all those involved. It is also important to present setbacks. An honest report with a presentation of coun
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