Innova. New E2/E3 Series. Safe Reprocessing of Flexible and Rigid Endoscopes

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1 Safe Reprocessing of Flexible and Rigid Endoscopes

2 Perfect Match of Reprocessing Parameters at Maximum Flexibility R e p r o c e s s i n g P r o c e s s a n d Te c h n o l o g y Well Equipped for the Future: the New INNOVA E2/E3 O v e r v i e w o f v e r s i o n s BHT the expert for innovative cleaning and disinfection technology for the reprocessing of endoscopes For more than 25 years BHT has been one of the acknowledged leaders in the development and production of innovative washer-disinfectors in the areas of healthcare, laboratory and pharmaceutical industry. BHT is a medium sized, internationally active enterprise with 2 production sites in the heart of Bavaria, Germany. Frost & Sullivan appreciated the innovative power, specifically in the field of endoscopy reprocessing by awarding the Product Innovation Price Healthcare 2005 for the BHT INNOVA CC for checking the individual channels of flexible endoscopes. Extensive patents and other protective rights document the high potential of BHT. Of course, BHT is certified according to ISO 9001:2000 and EN 13485:2003. The technology of endoscopy has opened new avenidas in healthcare for diagnosis and treatment. At the same time it has created new risks: Endoscopes can be a dangerous sources of infections. The cleaning and disinfection of these sensitive devices requires a comprehensive know-how of the manufacturer of washerdisinfectors (WDs). BHT has proven its competence by introducing the first fully automatic WD already in Since that time BHT is actively engaged to improve the safety conditions in reprocessing of medical devices, e.g. within the committee for preparing the new standard pren ISO /4. Water-/ disinfectant supply In all BHT WDs parameters such as time, temperature and used chemicals are precisely adjusted to the medical device to be reprocessed. BHT has realized a validatable reprocessing process where all phases are supervised. 1. Reliable sensors monitor the process data important for the result of the process. 2. The microcomputer supervises and registers all parameters. 3. Patented cleaning mechanics and process technology ensures superior efficiency and hygienic safety. 4. Patented, electronically supervised volume dosing guarantees the optimal employment of chemicals. Air-/water channel Suction channel Operation part Biopsy channel Distal end Supply plug Exit to insertion tube Channel for rinse of lens Additional channel for rinse of biopsy channel Safety in Reprocessing Compliant to pren ISO Validatable Type tested Compliant to German RKI (former BGA) regulations and European MDD guidelines Complete registration of reprocessing data Integrated leak test One system for all types The BHT load carrier can take water proof endoscopes of nearly all types of endoscopes. Three unique technical solutions 1. The pressure chamber system Proven to achieve a stable flow through the endocope channels. 2. The single channel adaptation principle Connects each channel individually with a supply tube (please see picture right). Functional Flexibility Treatment of almost all types of endoscopes of all endoscope manufacturers Chemicals of choice 1 (glutaraldehydes/per - acetic acids/chlorine dioxides/ph-neutral) Multi-functionality by using special load carriers (accessories, rigid endoscopes, MIS) 3 Compatible to INNOVA CC (individual channel check) internal or as external unit Operation completely via barcode (only at internal CC) Networking and extension capability via HMS 2 Rack coding 3 3. INNOVA CC (individual channel check) Option Checks the individual channels in the endoscope and detects channel restrictions/narrowings (E2 only external possible). Economical in Operation Use of consumptives can be optimized (water/chemicals) Reduced maintenance Optional multi-functionality 3 Modular, scaleable and combineable for operation in hospital and practitionar environment 1 pay attention to manufacturer's declaration of compliance. 2 HMS = Hygiene Management System. 3 only series 3 INNOVA E2 One of the smallest automatic endoscope reprocessors for small and medium sized departments. Suitable for: 1 endoscope per cycle flexible endoscope and accessories Suction area Supply tube Suction channel CO2-channel E3 for flexible and rigid endoscopes. Machine is equipped with batch printer for complete documentation. Optional available with operator friendly touch screen monitor and Innova CC system.

3 Features and Design High quality material such as stainless steel mm thick and proven synthetic material will withstand continuous stress Precise dosing The dosing related by volume and viscosity and controlled by the pro gram allows optimal operation in regard to efficiency and saving of cleaning agents and disinfectants. Final rinse alternatively with thermally disinfected water (patent ed) or with microbiologically filtered water. Alternatively with contact less cleaning in a pressure box, single channel adaptation or with measurement of flow. Optimal washing and drying effi Innova There is a System Behind a Perfect Reprocessing Easy service and simple maintenance With technology derived from other fields, such as the PC manufacturing, e.g. the side panels can be removed most easily to create access for ser v ice. Or, as shown on the photo com ponents can just be drawn out. ciency by turbine, if with pressure box system, and compressed air purg ing, if with individual channel adaptation. Safety Before and during the cleaning process a system with com pressed air generated by its own will check the endoscope for leaks. Additionally a protective overpressure will be maintained in the endoscope during the total washing phase. Each endoscope will be checked and the procedure will be documented. This, together with the instructions of the endo scope manufacturer on how to handle their endoscopes will guarantee the greatest security. The new E2/E3 offers also a fully validatable reprocessing. Ease of operation The docking device is easy accessible so that adaptation is fast and simple. Capable of networking and compatible to the Hygiene Manage ment System INNOVA HMS. Optimal solutions also in small details H eating elements are covered, thus preventing damage D ouble filter system in the pump circuit A n additional one-way valve prevents backflow of waste water in the system N o cross contamination because of the BHT completely-drain system (fractionated draining will keep residual below 5 ml) High pump power Water flow in a spiral tube, which avoids cavitation Vapour condenser (optional for series 3) for installation without connection to exhaust air duct

4 INNOVA CC (Channel Check) Compliant to the Highest Level of pren ISO Requirements A Perfect Result Checking & Cleaning of Individual Channels Quality Management BHT developed the INNOVA CC with Integrated Registration The controller offers the possibility of a check all channels of an endoscope for quirements for an endoscope specific gistration/documentation, thus an inte adaptation of individual channels to The new INNOVA E2/E3 fulfills the reindivid ual documentation of all process any restrictions. Biofilms, obstructions para meters of the reprocessing. or any other causes which narrow a channel will be detected and the opera tor will be warned in time. Even changes Optionally, the endoscope can be identi rapidly, thus avoiding further damage processing. in or at the channels will be identified fied by a barcode before starting the re and minimizing repair costs. transfer of data to an external PC for re gration into a sourrounding IT structure. All relevant reprocesssing data necessary for the implementation of a quality management system are provided. The INNOVA CC offers highest quality and validatable process security, thus improving the safety for operator and patient E3 CC handling for the reprocessing staff cost savings for the institution the quality and life time of the endo scope in comparison to conventional methods of reprocessing. The INNOVA CC system is available as free-standing unit in combination with existing washer-disinfector(s) or integrated into the INNOVA E2, E3, E4, E5 series of AERs (Automated Endoscope Reprocessors). Characteristics the endoscope and process data E xtremely sensitive flow control of in networking of machines and integra of each individual channel dividual endoscope channels. An error message will indicate if the cleaning of the channel was not sufficient. Program selection and scan function are designed ergonomically. registration tion into customer specific IT solutions by the INNOVA HMS Free-standing or integrated external CC unit nation with existing washer-disinfector(s) BHT was awarded by Frost CC system E5 series of AERs. The reprocessing of Innovation Price Healthcare N o additional time for the integrated Surface damage in new channels/visible scratches I ntegrated leak test O nly 6 8 min per endoscope at the Surface damage in the endoscope and detection of detritus (red) Barcode scanner for the operator, Fully automatic internal cleaning S uitable for all types of endoscopes and sizes Type, dosing and exact time of expo sure for chemicals adjustable in con formity to the endoscope c omplete documentation of reprocess ing data by the INNOVA HMS software available as free-standing unit in combi or integrated into the, E4, endoscopes with the BHT INNOVA AERs type E2, E3, E4 and E5 in combination with INNOVA CC is complying to the British HTM 2030 as well as to the future re quirements of pren ISO & Sullivan with the Product 2005 for the INNOVA CC INNOVA E2 system. Innova External barcode scanner and batch printer. New and visually attractive the optional touch pad.

5 Technique at a Glance A c c e s s o r i e s a n d Te c h n i c a l D a t a INNOVA E2 -CC Integrated Dimensions: Free-standing unit W/D/H Under-counter unit W/D/H Wash chamber W/D/H Volume 600 x 600 x 850 mm 600 x 600 x 825 mm 390 x 495 x 600 mm 116 l 800 x 680 x 850 mm 800 x 680 x 850 mm 540 x 510 x 535 mm 147 l 1200 x 680 x 880 mm 1200 x 680 x 850 mm 540 x 510 x 535 mm 147 l Material: Outer casing and wash chamber completely in stainless steel 304 Weight: 100 kg 150 kg 175 kg El. Connections: Connected Load Fuse: Connections: Wash Power: Drying: DI Water Boiler: Leak Test Device (independent): Dosing: Cold, warm, DI water Waste water Drain water hose Fresh water system, pump capacity Tank heating High pressure turbine Option: exhaust air condenser Thermal disinfection, volume Heating with heat recovery 230 V, 50 Hz 3,5 KW 16 A 40 DN 1/2 140 l/min effective 2,7 KW 80 m 3 /h Standard 10 l 3 KW 3N/AC 400 V, 50 Hz, 20 A 1 1/2 30 l/min DN l/min 7 KW 150 m 3 /h Optional 20 l 9 KW Automatic leak test system to check endoscopes, with analog pressure measurement 2 dosing systems with dosing supervision and dynamic dosing 3N/AC 400 V, 50 Hz, 20 A and 1N/AC 230 V, 50 Hz, 16 A 60 Hz on request 1 1/2 30 l/min DN l/min 7 KW 150 m 3 /h Optional 20 l 9 KW Microprocessor Control: Quality Management System Certified by DQS according to DIN EN ISO 9001: 2000 DIN EN ISO 13485: 2003 Reg. No programs for endoscopes, 1 program for accessories, 11 free program places programs for endoscopes 1 program for MIS-Instruments 2 programs for thermal disinfection (optional) RS232 interface for communication with PC, connection possible for barcode reader, printer interface, direct connection to INNOVA HMS for the external (E2) or intergrated (E3) operation of INNOVA CC. Barcode reader and batch printer optional (E2). Limited multi-functionality is possible with integrated CC. BHT Hygienetechnik GmbH Messerschmittstraße 11 D Gersthofen Tel. +49-(0)8 21/ Fax +49-(0)8 21/ hygiene@bht.de Internet: BHT Safe Reprocessing of Flexible and Rigid Endoscopes/08.07/E/2./DM Technical changes are reserved!