getinge aer range a safer way to reprocess
Contents
1. _ T a Se an fl L LeakTest GPY L 01 J GETINGE POKA YO KE AER Endoscope manufacture ji Endoscope name ezom Endoscope model ie ndoscope family cv Poka Yoke Recipe no 11 6 8 od Pentax manufacture RE 3 R Endoscope 7 WIYUY GETINGE POKA YOKE AE Endoscope eli er en Endosco ra GPY PEN Endoscope family 04 Poka Yoke Recipe no a er Bo en nr im Lo GPY SU 01 oy r GPY B 06 a PF loscope EC 250DL5 GETINGE POKA YOKE AER Endoscope manufacture Olympus Endoscope model duodenoscope TJF 240 Endoscope family GPY OLY I Poka Yoke Recipe no 18 2 Suction GPY SU 01 F 3 Biopsy GPY B 03 1 f 4 Water See air channe No image found A 5 Air GPY WA 02 Le a 6 Auxilliary Channel GPY AX 03 ie L LeakTest GPY L 03 J HandlePlug LFC S 01 The rotating nozzles deliver the washing disinfection and rinse fluids at a high pressure in the chamber and on the exterior of the endoscope a i i The endoscope is loaded into the ED FLOW on a loading tray You can prepare the endoscope on the tray on a work surface and then easily carry it over to the AER Every endoscope channel is individually connected to one of the six available snap on connections in order to clean and disinfect the internal channels of the endoscope a An LED panel gives you information about the cycle status at a glance The POKA YOKE AER features a unique2. design holder that makes it easier to load the endoscope By putting some space between the bottom of the chamber and the endoscope the holder also ensures that the disinfectant comes in contact with all external surfaces of the scope The ED FLOW AER features communication windows over each door to allow visual contact between people on both sides The interlocking doors of ED FLOW and POKA YOKE ensure that the endoscope cannot be unloaded on the clean side unless a complete process has been success fully carried out ne nn m It is very easy to connect the channels to the swinging arm connections module of ED FLOW And when unloading from the other side you just swing the module towards you for easy access to the connectors 15 16 A SAFER WAY TO HANDLE CHEMICALS NO EXPOSURE AT ALL We made our AERs extra easy to use in everyday work And we ve also simplified changing detergent and disinfectant bottles We have made it easier and much safer We made it impossible to make errors and minimised any exposure to chemicals High efficiency detergent Both ED FLOW and POKA YOKE use the detergent Getinge Poka Yoke DLC which is an alkaline type detergent with well documented efficiency for protein and biofilm removal The 3 litre bottles last for 60 cycles APERLAN for best disinfection efficacy The disinfectant used by both ED FLOW and POKA YOKE is the peracetic acid based APERLAN Poka Yoke delivered in tw
3. ER is the world s first true pass through AER with two asynchronous chambers so you can have a faster smarter more versatile and more efficient flow of flexible endoscopes through your reprocessing department Hands free operation both on loading and unloading sides means that you don t have to touch any panels or buttons with dirty hands Open the AER with the foot pedal let the RFID choose the right cycle and the AER starts automatically The pass through design of the ED FLOW AER allows a true physical barrier between soiled and clean sides Each chamber has two doors one for loading and the other for unloading of endoscopes Optimum traceability is built in Thanks to RFID tags info on operators and endoscopes is automatically stored and printed along with the cycle data And the Getinge software helps manage all data SETINGE The unique lid of the POKA YOKE AER lets you Nave a dirty to clean workflow even if your reprocessing room is small This is important in reducing cross contamination risks Unique handling of chemicals The APERLAN disinfectant bottles can only be placed in one way the right one The machine will also pierce and inject them so there s no operator exposure whatsoever To secure maximum infection control one must consider the whole workflow That s why we offer not only an endoscope reprocessor but a complete reprocessing system MODER
4. GETINGE GETINGE AER RANGE A SAFER WAY TO REPROCESS ENDOSCOPES ENDOSCOPE REPROCESSING FAST AND ERROR PROOF As the use of endoscopes increases so does the risk of infections linked to endoscope reprocessing This is indeed an area where zero tolerance towards cross contamination must be maintained And at Getinge we re convinced that there s only one way to do this Think SYSTEM not PRODUCT The Japanese word poka yoke stands for a concept aiming to make errors impossible When we designed our new range of AERs Automated Endoscope Reprocessors we applied poka yoke thinking We built it into the product and into the workflow around the products We applied a system approach in the way that we always do at Getinge the way of thinking that has made us the world leader in disinfection and sterilisation The Getinge range of AERs consists of two error proofing machines the Getinge ED FLOW AER and the Getinge POKA YOKE AER Both of them are unique And both of them represent a breakthrough for a more all embracing approach to infection control in endoscope reprocessing SAFER FASTER MORE VERSATILE AND EASIER TO USE Here are some of the main features and benefits The fastest and most efficient cycles No other AER can run such an extensive program confor ming to national and interna tional regulations in such a short time just 22 minutes Two separate chambers the ED FLOW A
5. N INFECTION CONTROL THERE S ALWAYS TWO SIDES TO IT Modern infection control is based on the barrier principle a clear separation of dirty and clean areas Both ED FLOW and POKA YOKE offer such a separation but in different ways ED FLOW a true pass through solution The ED FLOW is a true barrier system intended to be built in a wall in order to separate the dirty and the clean areas with a physical barrier Interlocking doors ensure that only scopes that have run through a complete and approved cycle can be unloaded through the door on the clean side If an error during the process is discovered the AER will only open up to the dirty side The two way lid design of the POKA YOKE AER helps to separate dirty and clean areas reducing the risk of cross contamination POKA YOKE a two way lid solution In smaller endoscopy clinics building the AER into a wall may not be a viable solution The POKA YOKE AER solves the problem by featuring a lid that allows loading and unloading from opposite sides Manual pre treatment is performed on the dirty side drying and storage on the clean side In this way disinfected endoscopes never have to be handled in the same area as dirty ones LOAD START AND UNLOAD WITHOUT TOUCHING Infection control is about seeing the whole picture and as far as possible ensuring the risk of human errors is eliminated For example how can you avoid the situation where a nurse touches a handl
6. NSING PURGE WITH AIR Triple rinses The final rinse uses Disinfection phase The standard Extensive rinses Every wash phase is Wash phase Ensures that all Initial flush phase Removes any pretreat ment chemical and removes gross contamination Special program for clean endoscopes saves time A shorter 15 minutes disinfection cycle is available for processed endoscopes that have been stored too long to use without renewed reprocessing To be used according proteins are removed Optional 2nd washing and rinsing phase can be programmed followed by a rinse plus an extra one for complete removal of detergent before disinfection program features a 5 minutes contact time performed at SO 0 1 um filtered water to guarantee the disinfected status of the endoscope Programmable thermal self disinfection program The self disinfection program uses thermal disinfection to reduce risk of cross contamination By pre setting the program for automatic start you know that the AER is to local regulations ready for use for example in the morning when you arrive Endoscopes are not like other instruments Disinfecting them is more complicated due to the complexity of the different internal channels How do you assure that these channels the inside of which no one will ever see have been completely high level disinfected and are 100 safe to use on the next patient after each reprocessing cycle H
7. YOKE AER Made of sturdy extruded aluminium brushes etc this trolley is positioned Helps to serve as a barrier between the the wall rail serves as a multi purpose under the pre treatment unit for easy dirty and clean sides Follows the holder Can be used to contain access Foot pedal opening shape of the POKA YOKE AER and is conceal wiring cables etc made of composite material 6 Chart holder 7 Connector holder system Mounted on the wall rail the swivel Also mounted on the wall rail the chart holder keeps instructions for connector holder transfers clean connec use manual pre cleaning etc close tors back to the dirty side for storage at hand and re use The connectors are safely and hygienically transfered in a practical disposable plastic bag LN 10 FD8 Drying and storage cabinet 8 Printer holder 9 Clean table Allows endoscopes to be aseptically The printer holder gives easy access to The clean table serves as a worktop for stored for up to 7 days and immediately print outs once the process is finished assembly of processed flexible endo available for use without further Mounted on the wall rail scopes Made of composite material reprocessing 23 EASY INSTALLATION AND COST SAVING SERVICE SOLUTIONS The Getinge AERs are designed to be very easy to install and service Putting them in place and connecting to water drain and electricity is quick and easy When it comes to the POKA YOKE AER choice of
8. al Getinge International AB PO Box 69 SE 310 44 Getinge Sweden Phone 46 35 15 55 00 Fax 46 35 18 14 50 info getinge com www getinge com GETINGE GETINGE GROUP is a leading global provider of equipment and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences Equipment service and technologies are supplied under the brands ArjoHuntleigh for patient handling and hygiene disinfection DVT prevention medical beds therapeutic surfaces and diagnostics GETINGE for infection control and prevention within healthcare and life science and MAQUET for surgical work places cardiopulmonary and critical care 1922 ENG 08 11 G teborgstryckeriet We reserve the right to make technical and construction changes
9. e panel start button or barcode reader after holding a dirty endoscope leaving micro organisms waiting to be picked up when unloading the clean endoscope The answer is touch free operation The first part is basic a foot pedal After the manual pre cleaning the operator presses the pedal to open the machine No need to touch any handles or buttons After succesful decontamination the door can only be opened with the pedal on the clean side Then the best part RFID identification and automatic start When the operator has placed the endoscope into the AER its RFID tag is automatically identified by the machine s RFID antenna RFID Radio Frequency Identification The operator also has a RFID tag for automatic user identification When the foot pedal is pressed the AER will close the lid door and automatically choose the right cycle for that endoscope based on the RFID tag information and start Smooth simple and failsafe This procedure has several benefits Firstly it is easy and saves time for the operator No data to be entered just load the endoscope and press the pedal Secondly it reduces the risk of human errors Only the correct cycle for that particular endoscope can be used The AER cannot be started or unloaded without storing the correct user information Thirdly it reduces the risk of cross contamination No buttons to be touched to open or close the lid select cycle enter user information start the machi
10. for endoscope reprocessing in Toulouse France Manufactured to the highest standards Thorough experience and well established expertise are prerequisites for reliable production of AERs The Getinge POKA YOKE AER and ED FLOW AER are manufactured at our Centre of Excellence for endoscope reprocessing in Toulouse France which has been manufacturing automated endoscope reprocessors since 1993 The new assembly line for the AERs has been built according to lean manu acturing principles Proven scientifically tested technology The Getinge AERs include proven scientifically tested technology on endoscope channel irrigation systems alarms regulation and monitoring of cycle parameters chemical combination efficacy compatibility and much more Getinge POKA YOKE AER and ED FLOW AER conform to the following norms among others e European Machine and Medical Device directives e EN ISO 15883 1 e EN ISO 15883 4 e HTM2030 HTMO1 C32 UK e DGS 138 Guide CTIN 11 2003 France Endoscope compatibility testing The Biotech Germande laboratory conducted an extensive testing of endoscope compatibility where endoscope materials and parts were exposed to the maximum dosing of disinfectant possible in the Getinge AERs and showed no deterioration BIUTECH GERMANDE i The results of the tests performed in BIOTECH GERMANDE laboratory Marseilles and the data provided by the endoscope washer disinfector manufacturer see Getinge_Foka Yo
11. ivider of the room However there are several options for positioning that enable a hygienic workflow see examples to the right Shelves for endoscope connectors and adaptors and a stand for a fliochart are examples of accessories that are conveniently close to the AER There are various ways of positioning the POKA YOKE AER in the reprocessing room Drying and storage on the clean side When the reprocessing cycle is completed the endoscope is unloaded on the clean side In this area you need a storage cabinet for sterile goods a printer for process data a wall mounted work bench for final assembly of the endoscope and an endoscope storage cabinet For details on all accessories see the following pages 21 22 ACCESSORIES FOR THE BEST POSSIBLE WORKFLOW Getinge offers everything you need to ensure the best possible hygienic workflow in your reprocessing department From endoscope connector kits to furniture for a smooth workflow Here are examples of accessories available For more information please visit www getinge com 1 Pre treatment unit 2 Chemical storage trolley For manual pre treatment of endoscopes before the process For storage of 2 2 disinfectant bottles and 3 DLC detergent Made of composite material bottles The trolley is also lockable to the pre treatment unit for safe storage 3 Waste trolley 4 U shaped transfer table for the 5 Wall rail For general waste such as gloves POKA
12. ke_compil data confirm that GETINGE PORA YORE AER GETINGE software version 1 using the DLC detergent and the APERLAN POXKAVOXE disinfectant is consistent with all requirements of EN ISO 158831 2006 and ISOLFDIS 15883 4 2007 Audrey BANG Chenier AHF Fa manage Chatty Assurance Urai mungen 1 T 1 Soot Cr 1 a Pr HiT ON HM ee EA 0 A a LE Endoscope connection All different connection kits and methods for every endoscope brand and model have been listed and successfully tested Scientific efficacy testing These tests were also performed by the Biotech Germande laboratory The tests included e Biocidal activity of the APERLAN Poka Yoke e Bactericidal fungicidal mycobactericidal virucidal sporicidal according to EN standards on disinfectants e Bactericidal and sporicidal activity of the disinfectant according to EN ISO 15883 4 e Cleaning efficacy tests according to EN ISO 15883 4 e Endoscope disinfection cycle efficacy tests according to EN ISO 15883 4 e Self disinfection cycle efficacy tests according to EN ISO 15883 4 including water treatment unit Functional testing The Getinge AERs have also been through many factory validation tests Seven prototypes have been tested as well as the first serial units 25 26 TECHNICAL DATA ED FLOW AER GETINGE 1100mm GETINGE ED FLOW AER GENERAL FEATURES Number of endoscopes 2 endoscopes in 2 separate chambers Compatibility
13. ne or unload the clean endoscope It couldn t be simpler or safer Just open it with the pedal and let the radio frequency sensor register user and endoscope ID and automatically launch the right cycle Hands free operation it s smart smooth and failsafe 10 TRACKING AND TRACEABILITY PROCESS VALIDATION AND VERIFICATION As a clinic or department using endoscopes the responsibility is normally yours to ensure that important procedure data is collected and stored Therefore you ll need an AER with a fail safe traceability system Ideally an AER would collect and store data automatically and therefore eliminate risks of human error when entering ID information It would also store all information automatically in a way that makes it easy to find exactly what you re looking for should you ever need it It would keep track of absolutely everything from cycle numbers endoscopes users surgeons and patient IDs to alarm histories and number of processes per endoscope With an AER like that you could really relax and focus on providing quality care spending less time on paperwork Exactly what you get with an AER from Getinge The RFID tags ensure automatic data collection Both endoscope and operator are automatically identified so the correct ID information is always collected The control system records the cycle number date endoscope ID type of cycle user ID cycle start and stop time Tracking and traceabili
14. o separate 4 5 litres bottles Agent A and Agent B The two agents are mixed inside of the machine and last for about 80 cycles APERLAN is used as single shot i e it is not recycled reused Disinfectant bottles can only be placed in one way the right way Since the bottles of Agent A and B have different shapes they can only be positioned in the place allocated for them No room for human errors The bottles don t have to be opened The bottles of Agent A and B are pierced inside the machine This means that the operator will not be exposed to any possible health hazardous chemicals Safer for the operator and no chemical fumes in the repro cessing room Warning when bottle levels are low The level of detergent and disinfectant is constantly monitored by the control system and can be displayed on the operator screen The system warns if levels are low no risk of running out of chemicals during a cycle The AERs feature a built in storage space for the detergent and the disinfectant bottles The large double door makes it easy to access the bottles and replace them 18 GETINGE ED FLOW THE WORLD S FIRST AER WITH TWO ASYNCHRONOUS CHAMBERS Getinge ED FLOW AER is the perfect solution for larger endoscopy departments where you may have 10 endoscopes or more and perform 5 000 procedures per year or More The ED FLOW offers excellent capacity with its two separate chambers and short cycles and for larger repr
15. ocessing departments it is of course also possible to install several ED FLOW AERs in a row With the world s first true pass through AER with two separate asynchronous chambers you get a faster more versatile and more efficient flow of flexible endoscopes through your reprocessing department Into the bargain you get outstanding infection control and compliance with all the latest standards to give you peace of mind Built into the wall ED FLOW is a true pass through solution that is the AER can be built into a wall to create a true physical barrier between soiled and clean sides Loading and unloading in different rooms is definitely the preferred solution wherever possible in order to minimize the risk of cross contamination Unique asynchronous chambers With double chambers operating independently you get a better workflow and greater flexibility Just load the soiled endoscope in one of the chambers as soon as it s ready for decontamination When the next one arrives you can load it directly into the second chamber without having to wait for the first endoscope s cycle to finish and start the reprocessing Unlike some other one chamber AERs you don t have to wait until you have two scopes to reprocess before launching the cycle Examples of positioning of ED FLOW in reprocessing department layouts Endoscopes can be prepared on a tray on a work surface before it s loaded into the AER The
16. ow can you be completely sure that each channel is 100 functional and that there is no obstruction due to bio film buildup threatening the scope s perfomance There is only one way The unique CVL system Channel irrigation Verification Library which measures each channel separately and warns if there is the slightest deviation compared to predefined values This is something that other AERs don t offer you And it is priceless for you who appreciate peace of mind when it comes to patient safety It works like this 1 The first four times an endoscope is reprocessed the AER automatically checks the pressure of each channel four times five times if 2nd washing and rinsing phase has been programmed 2 The AER compares the measured flow rates to pre defined values that have been specified by the manufacturers for the specific type and model of endoscope in order to assure that the cleaning and disinfection of each channel is correctly performed 3 What s more the measures are automatically stored by the AER as reference values for that particular endoscope values that will be used throughout its lifetime Every individual channel in the endoscope has its own pattern value for reference 4 During operation the AER automatically compares the flow of each channel of each endoscope with the known reference values If there is a deviation in the flow rate during the cycle the AER notices it You can set the AER to either jus
17. same tray is then loaded inside the machine and can be used for transportation to the procedure room System approach Getinge ED FLOW AER has a very small footprint a depth of only 45 cm on each side when fitted into a wall and can be positioned in many ways in the reprocessing department In order to ensure the best possible hygienic workflow we have also developed a range of accessories to create a complete reprocessing system 19 GETINGE POKA YOKE AER ASYSTEM APPROACH OFFERING UNIQUE BENEFITS FOR SMALLER CLINICS ul Getinge POKA YOKE AER is the ideal solution for Manual pre treatment in a dedicated part of the room After the initial manual cleaning and flushing of channels has been performed in the procedure room the endoscope is smaller endoscopy clinics Here there is often not enough space to build a machine into a wall in order to separate dirty and clean areas Thanks to the smart lid opening to brought into the reprocessing room Here there is a the opposite side for unloading the POKA YOKE allows dedicated area for continued manual cleaning on one side of the POKA YOKE AER Equipment in this area includes sinks spray guns automated water tap preparation area shelf for brushes waste bin etc a soiled to clean workflow even in a small room 20 The AER as a semi divider of the room Ideally the AER is placed out from the wall by a special wall mounted work bench to function as a semi d
18. sible with scanner olutions please refer to our T DOC System 12 za A E l KW NM E ii SER N v y EW m CY 4 N A Ey 4 i J BE m PA N a Fe i AN Sa A gt 9 i Fe MM a a a l DT u 2 m Be gt ial j E B Pr N FA N AM Y awa Y N ie wll zz a YA LN WI E mE Y N L A Y f i AN AT a y WM gi Mi m AS DEW T y C AY Y l BEN ul T e EB fm amp BA Y Y La tad The standard program for the Getinge AERs features continuous leak tests five flow tests and three final rinses It s been designed to meet all regulations including the ones in countries where demands have increased following the emergence of prion diseases No other machine can complete so many phases in such a short time As a result the Getinge AERs will complete a cycle fully validated to EN ISO 15883 1 and EN ISO 15883 4 in only 22 minutes This means for example that the ED FLOW will process as many as 6 scopes in just over an hour On top of this you can save time thanks to the smart ergonomic design of the AERs Loading scopes is very easy and connecting them is really fast And all the time you have a good overview of the chamber which contributes further to a smooth and simple workflow STANDARD CYCLE DESCRIPTION PERMANENT LEAK TEST DISINFECTION FINAL RI
19. sted for all kinds of endoscopes Both Getinge POKA YOKE AER and ED FLOW AER are developed for and extensively tested with all tyoes and brands of flexible endoscopes They handle scopes for amongst others upper and lower GI endoscopy cystoscopy hysteroscopy bronchoscopy and rhinolaringoscopy Easy to connect any type of endoscope The Getinge AERs identify the endoscope and display help for the operator on the screen Also each tube for the connection of internal channels has a different colour to make correct connection easy Customised and skillfully engineered endoscope connection kits are available for each endoscope model Connector database on the web for Getinge customers As a user you get access to a dedicated customer area Here you will find information about use technical features and an easy to navigate endoscope connection database This gives you quick and constant access to updated connection information Tested according to local regulations Se Fee ol pl F E Ue ee E i De a GETINGE 20 CA IT Fe ee 4 MATA LA EA jeta a BBEITTTE a Farga Ya Partwerdt her mir eee IN dear mio gara pata ee A A AA FE MI A ee ls ces e o ee U bri ee a er NINS RT Mr oe WO fT Ae nl HE i Sa dd e pes GETINGE POKA YOKE AER Endoscope manufacture Karl Storz Endoscope name Customer B Endoscope model ENT 11101 RP Endoscope family GPY STO A Poka Yoke Recipe no 01 E
20. t make note of small deviations to review and assess when going through the reports or to trigger a clear warning when outside tolerance so that the cycle can be stopped This way you know that continuous safety is always assured The CVL functions as a quality assurance letting you feel confident that everything works as it should on a day to day basis gt CHE Normal pressure Everything works correctly and the flow is normal gt DA High pressure CVL warns The pressure is high but the flow through the channel is very low Possible cause obstruction due to bio film build up or damage Low pressure CVL warns The pressure is very low still the water and chemicals seems to flow totally unhindered Possible cause the endoscope is not connected As decontamination in an AER is a terminal final process prior to use on a patient you have to be absolutely sure that the disinfection has been 100 successful Thanks to the CVL system you can rest assured 13 14 EASY TO USE WITH ALL ENDOSCOPES CONNECTOR DATABASE ON THE WEB The Getinge Infection Control Group knows a thing or two about safe reprocessing Being the world leader in disinfection and sterilisation it is even tempting to claim that we know more about it than anyone So both you and the manufacturer of your endoscopes can rest assured whatever the type or brand a Getinge AER is tested to provide full compatibility and efficacy Te
21. ter consumption per cycle phase 3 25 litres HEPA filter for incoming air Y Weight 150 kgs CONTROL VALIDATION TRACEABILITY Industrial PLC system Programmable Logic Controller Y Printer Program for identification of endoscopes and CVL identification RFID identification of endoscope RFID identification of user Automatic dosing of detergent Automatic dosing of disinfectant Independent cycle parameters monitoring system Cycle documentation system Ethernet IP address for Remote S SN NS ONS SS INCLUDED FOC ON DELIVERY Endoscope RFID tags 3 pcs User RFID tags 2 pcs Machine disinfection tag Ao 600 Y Machine disinfection tag Ao 3000 Y Machine disinfection chemical Y User manual Y 21 TRACEABILIT Getinge provides complete solutions for effective and efficient cleaning disinfection and sterilization in the healthcare and life science sectors Our know how comprises everything from architectural planning production and handling equipment to systems for full traceability of sterile goods Our commitment covers expert advice training and long term technical support GETINGE Getinge Infection Control PO Box 69 SE 310 44 Getinge Sweden Phone 46 35 15 55 00 Fax 4635 18 14 50 info getinge com www getinge com United Kingdom Lancer UK Ltd 1 Pembroke Avenue Waterbeach UK Cambridge CB25 9QP Phone 44 0 1223 861665 Fax 44 0 1223 861990 sales lancer co uk www lancer co uk Internation
22. to all endoscopes according to EN ISO 15883 1 and EN ISO 15883 4 Y Glass doors true pass through for building into a wall Y SPRAYING 8 CVL SYSTEM 6 rotating nozzles 360 Y 6 internal channel connections colour coded Y CVL system Y MACHINE DISINFECTION Thermal disinfection cycle Y Chemical self disinfection Y ENDOSCOPE DISINFECTION CYCLES Permanent leak test Y Max number of channel irrigation tests during full cycle 5 Working temperature SE Automatic mixing of disinfectant inside machine Y Standard time of contact with disinfectant 5 min Adjustable final air blowing time Y Disinfectant Aperlan Poka Yoke Agent A 4 5 litres box of 2 bottles Disinfectant Aperlan Poka Yoke Agent B 4 5 litres box of 2 bottles Detergent Getinge Poka Yoke DLC 3 litres box of 1 bottle 1220mm 4 WO Y CONNECTION OF UTILITIES Electrical connections consumption A400V N 10 16A ph 230V 10 28A ph Water supply To national guidelines and requirements Minimum softened water lt 7 DH Incoming water filter 0 1 um Y Water consumption per cycle phase 3 25 litres HEPA filter for incoming air Y Weight 400 kg CONTROL VALIDATION TRACEABILITY Industrial PLC system Programmable Logic Controller Y Printer Program for identification of endoscopes and CVL identification RFID identification of endoscope RFID identification of user Automatic dosing of detergent Automatic dosing of disinfectant Independent c
23. ty There are two basic traceability software packages for ED FLOW and POKA YOKE available for you to choose from LEVEL 1 Saves all data for you The LEVEL 1 package includes a Getinge software package for easy storage and management of all data on a PC All cycle parameters alarms endoscope numbers and user IDs are automatically documented All information is easy to search read and print LEVEL 2 Patient ID and handling of chemicals The LEVEL 2 software package also adds patient ID documentation which is a legal requirement in many areas of the world Date cycle endoscope user alarm number surgeon physician ID and patient can be easily searched directly on the screen of the computer making things even simpler In addition this traceability package supports direct registration of LOT number and handles your stock of consumables manually or by barcode registration A compact easy to load printer is also available where the Level 1 software cannot be used Printer ticket contains traceability information Tracking and traceability software solution LEVEL 1 LEVEL 2 Cycle documentation Endoscope serial no RFID tag no User ID both loading and unloading ID Sell ne Screen search for date amp cycle Patient ID Screen search for endoscope user alarm no amp patient ID Handling of chemicals Lot No ordering etc Surgeon physician ID SIEA IES IES TES IT 1 5 5 SS Patient ID reg pos
24. unloading mode can be made at installation by selection in the software for either same side unloading or opposite side unloading This setting can also be easily changed later for example if a new reprocessing room layout will allow the dirty to clean workflow that wasn t possible at installation All the training support you may need We offer operator training to ensure that the AER can be optimally utilized to its full potential To prevent breakdowns and minimise the risk for undesired downtime there is also training available for your technician at the unit The training sessions can be held either at your facility or at the Lancer Getinge Academy Preventive maintenance and validation packages We also offer a range of preventive maintenance service contracts as well as validation and training packages which can be tailored to your own requirements e Installation to agreed services e Commissioning e Installation 4 Operational Testing IOT validation to EN ISO 15883 1 4 HTMO1 06 e Performance Qualification PQ validation testing to EN ISO 15883 1 4 HTMO1 06 e Servicing and service contracts e Quarterly testing to EN ISO 15883 1 4 HTMO1 06 e Annual revalidation testing to EN ISO 15883 1 4 HTMO1 06 e Revalidation to EN ISO 15883 1 4 HTMO1 06 e Repeat validation to EN ISO 15883 1 4 HTM01 06 CONFORMS TO ALL NORMS AND STANDARDS AND THOROUGHLY TESTED IN EVERY WAY 4 dr EIG mr i iii Our Centre of Excellence
25. ycle parameters monitoring system Cycle documentation system Ethernet IP address for Remote S SN SAS ON OS SS INCLUDED FOC ON DELIVERY Endoscope RFID tags 3 pcs User RFID tags 2 pcs Machine disinfection tag Ao 600 Machine disinfection tag Ao 3000 Machine disinfection chemical Y Y Y User manual Z TECHNICAL DATA POKA YOKE AER GETINGE POKA YOKE AER GENERAL FEATURES Number of endoscopes Compatibility to all endoscopes according to EN ISO 15883 1 and EN ISO 15883 4 Y Blue tinted glass lid can open to both sides Y SPRAYING 8 CVL SYSTEM 4 rotating nozzles 360 6 internal channel connections colour coded Y CVL system WA MACHINE DISINFECTION Thermal disinfection cycle Chemical self disinfection J ENDOSCOPE DISINFECTION CYCLES Permanent leak test Max number of channel irrigation tests during full cycle 5 Working temperature 37 C Automatic mixing of disinfectant inside machine Y Standard time of contact with disinfectant 5 min Adjustable final air blowing time Y Disinfectant Aperlan Poka Yoke Agent A 4 5 litres box of 2 bottles Disinfectant Aperlan Poka Yoke Agent B 4 5 litres box of 2 bottles Detergent Getinge Poka Yoke DLC 3 litres box of 1 bottle 1332mm CONNECTION OF UTILITIES 230V 10 26A ph 400V N 10 8A ph Electrical connections consumption Water supply To national guidelines and requirements Minimum softened water lt 7 DH Incoming water filter 0 1 um Y Wa
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