Getinge Poka - Yoke AER Washer-Disinfector

POKA-YOKE MEANS “ERROR-PROOFING”

POKA-YOKE AER–A SAFER WAY TO REPROCESS FLEXIBLE ENDOSCOPES

The Japanese word Poka-Yoke stands for a concept aiming to make errors impossible. When we designed our new AER (= Automated Endoscope Reprocessor), we applied Poka-Yoke thinking.

Product Description

The Getinge POKA-YOKE is an AUTOMATED ENDOSCOPE REPROCESSOR (AER) which performs washing, high-level disinfection and rinse of flexible endoscopes.

The POKA-YOKE AER features 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. The design of the AER creates a barrier between dirty and clean areas, reducing the risk of cross-contamination. In this way, the POKA-YOKE AER functions as the core of a complete hygienic system, ensuring maximum hygiene safety even where space is limited.

The POKA-YOKE AER has all features to prevent endoscope reprocessing errors, thus eliminating defects in the washing and disinfection process, and ultimately adding quality and safety in the infection control in the endoscope centers.

Product Features

				Features in short
Thanks to the unique lid design, you can have a dirty-to-clean workflow even if your reprocessing room is small. This is important in reducing cross-contamination risks.		Hands-free operation, both on loading and un-loading 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.		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.
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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.		The cycles are fast and efficient for all flexible endoscopes. In fact, no other AER can run such an extensive program, conforming to national and international regulations, so quickly.		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.

Modern infection control is based on the barrier principle, a clear separation of dirty and clean areas.

However, in a smaller endoscopy clinic, this might be difficult to achieve. Double-door AERs are usually designed for larger departments, with many endoscopes and lots of space.

The two-way lid – a smart 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. The design of the AER creates a barrier between dirty and clean areas, reducing the risk of cross-contamination.

On the next page, you’ll see an example of how the POKA-YOKE AER functions as the core of a complete hygienic system, ensuring maximum hygiene safety even where space is limited.

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 successful 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 machine or unload the clean endoscope.

It couldn’t be simpler – or safer.

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 traceability

There is a modular traceability software package for Getigne ED-FLOW AER and Getinge POKA YOLE AER available; T-DOC EndoCycle.

The EndoCycle 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!

The modular 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).

AN EXTENSIVE PROGRAM COMPLETED IN ONLY 22 MINUTES

The standard program for the Getinge AERs features continuous leak tests, four 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 ISO 15883-4 and ISO 1583-1 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.

Special program for clean endoscopes – saves time

A shorter 13 minutes disinfection cycle is available for processed endoscopes that have been stored too long to use without renewed reprocessing. To be used according to local regulations.

Programmable thermal self-disinfection program

The self-disinfection program uses thermal disinfection to reduce risk of contamination. By pre-setting the program for automatic start, you know that the AER is ready for use, for example in the morning when you arrive.

EVERYTHING DOCUMENTED – WITHOUT YOU HAVING TO LIFT A FINGER

As a clinic using endoscopes, the responsibility is yours to ensure that important procedure data is collected and stored. Therefore, you’ll need an AER with a fail-safe traceability system.

UNIQUE SAFETY FEATURE: THE CVL-SYSTEM
This is something that no other AER can offer you. It’s called CVL (Channel irrigation Verification Library) and it’s a bit complicated – but very smart: 1. The first four times an endoscope is reprocessed, the POKAYOKE AER automatically checks the pressure of each channel six times – and stores the values. 2. These 24 measures mean that every individual channel in the endoscope has its own pattern value for reference. 3. What’s more, the AER also has a database with all the preset values for minimum flow that are specified by the manufacturers for different kinds of scopes. 4. During operation, the POKA-YOKE AER automatically compares the flow of each channel of each endoscope with A) the pattern value of the specific endoscope; and B) the required values set by the manufacturer. 5. If there’s a significant deviation of the pressure compared to the reference values, the AER notices it. You can set the AER to either just make note of the deviation to assess when going through the reports and to trigger a clear warning so that the cycle can be stopped. This way, you know that continuous safety is always assured. The CVL system will warn you if deviation in flow are noticed inside the channels, when an endoscope channel is blocked or disconnected. The CVL functions as a quality assurance, letting you feel confident that everything works as it should on a day-to-day basis. EASY TO USE WITH ALL KINDS OF FLEXIBLE ENDOSCOPES Naturally, manufacturers of flexible endoscopes often recommend their preferred brand of AERs. It’s understandable that they want to make sure that the function of their products is not compromised by reprocessors whose performance they have no control over. But let us put it this way: We’re not an endoscope manufacturer but Getinge Infection Control Group know a thing or two about safe reprocessing. Being the world leader in disinfection and sterilization, 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, the POKA-YOKE AER is tested to provide full compatibility and efficacy. Tested for all kinds of endoscopes Getinge POKA-YOKE AER is developed for and extensively tested with all types and brands of flexible endoscopes. It handles scopes for upper and lower GI endoscopy, cystoscopy*, hysteroscopy*, bronchoscopy and rhinolaringoscopy. Easy to connect any type of endoscope The POKA-YOKE AER identifies the endoscope and displays 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. Connector database on the web for POKA-YOKE users As a POKA-YOKE user, you get access to a dedicated POKA-YOKE customer area.		Features There are four rotating nozzles to deliver the washing, disinfection and rinse solutions a high pressure in the chamber and on the exterior of the endoscopes. Every endoscope channel is individually connected to one of the six available internal connections, in order to clean and disinfect the internal channels of the endoscope. Cycle status and time left – an LED panel gives you information at a glance. The POKA-YOKE AER features a unique 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 endoscope.

A SAFER WAY TO HANDLE CHEMICALS
		As we see it, the performance of a machine is defined not only by how well it does its job in general, but also by its interaction with the operator. We want to make every machine as easy and safe to use as possible. This is fundamental to us at Getinge. When it comes to the POKA-YOKE AER, we made it extra easy to use in everyday work. But we’ve also simplified changing detergent and disinfectant bottles. We have made it easier – and much safer. We have made it impossible to make errors – and minimised any exposure to chemicals. High-efficiency detergent The Getinge Poka-Yoke DLC is an alkaline type detergent with welldocumented efficiency for protein and biofilm removal. The 3 litre bottles last for 30 cycles, allowing about one week operation without need to change the detergent bottle. APERLAN for best disinfection efficacy The disinfectant used is the peracetic acid-based APERLAN Poka-Yoke, delivered in two separate 4,5 litre bottles – Agent A and Agent B. The two agents are mixed inside of the machine and last for about 70–80 cycles. The APERLAN is used as single shot, i.e. it is not recycled/reused. The 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. The safety for the operator is increased and there are no chemical fumes in the reprocessing 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.

ACCESSORIES FOR A FULLY EQUIPPED REPROCESSING ROOM

1. Pre-treatment unit For manual pre-treatment of endoscopes before the process. Made of gentle composite material.		2. Chemical storage trolley For storage of 2+2 disinfectant bottles and 3 DLC-detergent bottles. The trolley is also lockable to the pre-treatment unit for safe storage.
3. Waste trolley For general waste such as gloves, brushes etc, this trolley is positioned under the pre-treatment unit for easy access. Foot-pedal opening.		4. U-shaped transfer table Serves as a barrier between the dirty and clean sides. It has the same shape as the Poka-Yoke AER and is made of gentle composite material.

5. Wall rail Made of sturdy extruded aluminium, the wall-rail serves as a multi-purpose holder. Can be used to hold/conceal wiring, cords etc.		6. Chart holder Mounted on the wall-rail, the swivel chart holder keeps instructions for use/manual pre-cleaning etc close at hand.

7. Connector holder system Also mounted on the wall-rail, the connector holder transfers clean connectors back to the dirty side for storage and re-use. The connectors are safely and hygienically transfered in a practical disposable plastic bag.		8. Printer holder The printer holder gives easy access to print-outs once the process is finished. Mounted on the wall-rail.		9. Clean table The clean table serves as a worktop for assembly of processed flexible endoscopes. Made of gentle composite material.

The Getinge POKA-YOKE AER is designed to be very easy to install and service. Putting it in place and connecting to water, drain and electricity is quick and easy.

Choice of 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 minimize 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:

• Installation to agreed services

• Commissioning

• Installation & Operational Testing (IOT) validation to EN ISO 15883-1

• Performance Qualification (PQ) validation testing to EN ISO 15883-1

• Servicing and service contracts

• Quarterly testing to EN ISO 15883-1

• Annual revalidation testing to EN ISO 15883-1

• Revalidation to EN ISO 15883-1

• Repeat validation to EN ISO 15883-1.