Getinge Washer - Disinfector Ed- Flow, Poka-Yoke AER

ENDOSCOPE REPROCESSING – FAST AND ERROR-PROOF

A safer way to reprocess flexible endoscopes

Getinge ED-FLOW AER (= Automated Endoscope Reprocessing) is the perfect solution for large endoscope departments. With two separate chambers and short cycles our ED-FLOW offers excellent capacity for these environments.

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.

This was built it into the product, and into the workflow around the products, applying a system approach.

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.

Product Description

Getinge ED-FLOW AER is the perfect solution for endoscopy departments where you have 10 or more endoscopes and/or perform over 5,000 procedures per year. This machine is a unique combination of two asynchronous chambers, double doors and pass through Automated Endoscope Reprocessor enhancing high flows of washing, disinfection and rinsing of flexible endoscopes.

The Getinge ED-FLOW is fully compliant with the ISO 15833-1 & 4 regulations and is fitted with a set of innovative error proofing features for safe and reliable washing and disinfection of flexible endoscopes.

Product Features

Here are some of the main features and benifits:

The fastest and most efficient cycles. No other AER can run such an extensive program conforming to national and international regulations, in such a short time – just 22* minutes!* 26 minutes when a second wash phase is required		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		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.		Unique handling of chemicals. The APERLAN POKA YOKE A & B 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
---------------------------------------		---------------------------------------		---------------------------------------		---------------------------------------
Two separate chambers – the Getinge ED-FLOW AER 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.		The pass-through design of the Getinge 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.		The pass-through design of the Getinge 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.		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

– 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 Getinge ED-FLOW AER and Getinge POKA YOKE AER offer such a separation – but in different ways.

MODERN INFECTION CONTROL

Getinge ED-FLOW AER – a true pass-through solution

The Getinge ED-FLOW AER 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.

Getinge POKA YOKE AER – a two-way lid solution

In smaller endoscopy clinics, building the AER into a wall may not be a viable solution. The Getinge POKAYOKE 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.

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.

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 handle, 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 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.

UNIQUE EXTRA SAFETY THANKS TO THE CHANNEL IRRIGATION SYSTEM

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?

How 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. [CVL availability is dependent on the endoscope design]

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 pressure 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 just 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.

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.

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.

1. Pre-treatment unit For manual pre-treatment of endoscopes before the process. Made of 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 for the Getinge POKA-YOKE AER Helps to serve as a barrier between the dirty and clean sides. Follows the shape of the Getinge POKA-YOKE AER and is made of composite material.		5. Wall rail Made of sturdy extruded aluminium, the wall-rail serves as a multi-purpose holder. Can be used to contain/ conceal wiring, cables 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 hygieni cally 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 composite material.

Manufactured to the highest standards

Thorough experience and well-established expertise are prerequisites for reliable production of AERs. The Getinge POKA-YOKE AER and Getinge 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.

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 Getinge ED-FLOW AER conform to the following norms among others:

• European Machine and Medical Device directives 93/42/CE

• ISO 15883-1

• ISO 15883-4

• 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.

Endoscope connection We have developed* the appropriate connection kits for the main endoscopes of the major manufacturers.

(Contact us for availability).

Scientific efficacy testing

These tests were also performed by the Biotech- Germande laboratory. The tests included:

• Biocidal activity of the APERLAN Poka-Yoke

• Bactericidal, fungicidal, mycobactericidal, virucidal, sporicidal according to standards on disinfectants

• Bactericidal and sporicidal activity of the disinfectant according to ISO 15883-4

• Cleaning efficacy tests according to ISO 15883-4

• Endoscope disinfection cycle efficacy tests according to ISO 15883-4

• Self disinfection cycle efficacy tests according to ISO 15883-4 (including water treatment unit).