Frequently Asked Questions
ENT – key questions answered clearly.
Can I sterilize my ENT instruments and rigid endoscopes in the autoclave?
Yes. Autoclavable, heat-resistant instruments and rigid endoscopes can be reprocessed safely in a Klasse B autoclave. For flexible, heat-sensitive endoscopes we recommend thermal or chemical reprocessing – we are happy to advise you on this.
Which instruments in an ENT practice have to be sterilized?
Critical instruments that come into contact with blood, wounds or mucous membranes, or that penetrate tissue, must be sterilized – such as ear, nose and throat instruments. Classification into non-critical, semi-critical and critical is carried out via a risk assessment in accordance with the KRINKO recommendation.
What does Klasse B mean for an autoclave?
Klasse B refers to full-featured steam sterilizers with a fractionated vacuum process that also reliably sterilize wrapped, hollow and porous instruments. For instrument reprocessing in medical facilities, a Klasse B device is mandatory in Germany.
What is the difference between Klasse B and Klasse N?
Klasse B fully sterilizes wrapped, unwrapped, hollow and porous instruments using a vacuum process. Klasse N may only sterilize unwrapped, solid instruments and is not permitted for human medicine. For an ENT practice you need a Klasse B device.
Which autoclave size makes sense for an ENT practice?
For ENT practices we usually recommend 12–18 L. The right size depends on your instrument volume and the desired buffer capacity. In the autoclave configurator you will find the right recommendation including accessories in just a few minutes.
Do your devices help me meet the RKI requirements?
Yes. All devices are Klasse B according to EN 13060. With SteriTrace® you document every batch in an audit-proof, paperless way; we handle validation and maintenance on site.
I'm not familiar with Steri24 – why should I switch?
Steri24 sells directly – without the detour via depots or middlemen – and handles the service itself. This gives you a dense on-site service network like that of established expensive providers, but at fairer prices. Manufacturer since 1957.
What happens to my old autoclave?
We advise you on switching, take back your old device on request during installation and dispose of it properly – regardless of manufacturer.
How quickly do you deliver and install?
Devices are usually available at short notice. On request we handle delivery, installation and commissioning in accordance with the legal requirements, as well as the initial validation on site.
Which model suits my practice – Premium or Pro?
Both lines are Klasse B and RKI-compliant. Premium offers digital batch release on the touchscreen, LAN/WLAN and integration with the practice software; Pro is robust, simple and great value with documentation via USB and thermal printer. The configurator helps with the choice.
Can I connect the autoclave to my practice software?
With the Premium model you connect the autoclave to common practice software via LAN/WLAN and release batches digitally. With the Pro, documentation is done via USB and thermal printer.
How do I document batches in an RKI-compliant way?
You have the choice: paperless on the touchscreen with SteriTrace®, via your practice software (Premium) or the classic way via USB and printout. This way you meet the RKI requirements for complete, traceable batch documentation.
What is SteriTrace® and what advantage does it offer?
SteriTrace® is the paperless documentation assistant: digital release, complete traceability and integration with common practice software. This saves time in everyday work and is ideal for QM and inspections.
Is validation mandatory for my ENT practice?
As soon as you reprocess critical instruments that come into contact with blood, validation is mandatory; the basis is, among other things, the MPBetreibV. Whether it is mandatory in your case depends on the area of use – we are happy to advise you.
What does validation of an autoclave mean?
Validation is a formal test that proves your autoclave and the entire reprocessing process meet the applicable standards and sterilize reliably. It is usually carried out every 2 years on site with your instruments as the load.
How does the initial on-site validation work?
An accredited validation engineer uses measuring sensors to check whether your autoclave meets all requirements at the place of use – including a vacuum test, empty-chamber profile and several sterilization runs with your instruments. Afterwards you receive a validation report.
Must validation always be carried out on site?
Yes, validation is carried out exclusively on site with your instruments as the load, because it tests the actual conditions at the place of use. Shipping the device to the factory is not possible for this.
At what interval must revalidation be carried out?
Revalidation is usually due every 2 years or after 1,000 cycles and is carried out on site. For larger devices or a very high number of cycles, a shorter interval may be required.
Can I use the device before the initial validation has been carried out?
Yes. The autoclave is ready for use immediately after delivery and commissioning; the initial validation is a process validation and can be made up in a separate appointment.
Can I carry out the validation myself?
No. Validation must be carried out by an accredited validation engineer with special measuring technology. Steri24 handles the entire process on site.
At what interval must the autoclave be serviced?
Maintenance is legally required every 24 months, but sooner if 1,000 sterilization cycles are reached – whichever comes first. This applies to Germany, Austria and Switzerland.
Is maintenance also necessary with low usage?
Yes. Maintenance is legally required every 24 months, regardless of the actual number of cycles. Only with very high usage does it become due sooner.
What is a maintenance contract and what does it include?
A maintenance contract secures the required servicing and extends the warranty. We remind you in good time, arrange the appointment and take care of the work, spare parts and report – the contract itself is free of charge.
Do you handle maintenance and validation of devices purchased from you?
Yes, we handle maintenance and validation of the devices purchased from us – including installation and initial validation on site and, on request, as part of a maintenance contract.
Does the service also come to my practice?
Yes. We have trained technicians and service partners throughout DACH who come on site for installation, validation, maintenance and repair. Travel is free of charge.
How quickly is a technician on site in the event of a defect?
In the event of a defect, our technicians are usually on site within a few working days, depending on the location. For emergencies there is a 24-hour hotline – even on weekends.
Is there a loan device if my autoclave fails?
Yes, in the event of a defect or during factory maintenance, a replacement or loan device is usually available within a few days, so your practice can keep running.
Do you also repair after the warranty has expired?
Yes, we repair and service your device even after the warranty has expired – also without a maintenance contract. The usual service and spare-parts costs then apply.
How long do the devices last?
With regular maintenance every 2 years, our autoclaves have a long service life of many years. During maintenance, all critical parts that are scheduled to be replaced are exchanged. We keep spare parts in stock long-term.
Which water may I use?
Use distilled or demineralized/fully desalinated water with the lowest possible conductivity. Commercially available distilled water is suitable. Tap water and technical battery water are not suitable and can damage the device.
Do I need a fixed water connection?
No. All devices are stand-alone units with an integrated fresh- and waste-water tank and can be filled manually. A fixed water connection is optionally available and can also be retrofitted later.
Can I automate the water filling?
Yes. With a water treatment unit such as the AQUAdem 40, tap water is automatically converted into demineralized water and the autoclave refills itself – you no longer need to buy distilled water.
How long does a sterilization cycle take?
The duration depends on the model, program and load. Guideline values at full load with wrapped instruments: 12 L approx. 30–35 minutes, 23 L approx. 45–50 minutes. A quick program shortens the runtime.
Which programs does the autoclave offer?
The devices have several programs, including Universal/Solid, Hollow, Porous/Textile and Prion, as well as a short/quick program and a vacuum test. The exact list is in the operating manual of the respective model.
Which program do I choose for wrapped instruments?
For wrapped instruments and hollow items, use the Hollow program (Universal 134 °C or 134 °C Hollow). Solid is for unwrapped instruments without cavities, Porous is for textiles.
Can hollow instruments such as suction tips be sterilized?
Yes, Klasse B autoclaves are suitable for hollow items. Select the Hollow program so that the fractionated vacuum process allows the steam to reach the cavities as well. The only exceptions are instruments that the manufacturer expressly labels as not autoclavable.
Do instruments have to be wrapped?
Critical instruments that come into contact with blood or penetrate skin/mucous membranes must be sterilized wrapped. Non-critical and semi-critical instruments may be sterilized unwrapped; a mixed load is also possible.
When does the batch number have to be written on the packaging?
Always after sterilization. At minimum, the batch number is written on the wrapped instruments, ideally with a suitable sterilization pen. Tracing labels are also applied after sterilization.
Do I also need a sealing device?
For packaging critical instruments, a validatable sealing device is required. With our CertoSeal sealing devices you package your instruments in compliance with the standards. This lets you put together the entire reprocessing workflow from a single source.
Do I need a washer-disinfector or ultrasonic cleaner for pre-cleaning?
A washer-disinfector/WD or ultrasonic cleaner cleans and disinfects semi-critical instruments, but does not replace the sterilization of critical instruments in the autoclave. Which solution fits depends on your instruments – we are happy to advise you.
Can I get the entire reprocessing workflow from a single source?
Yes. The autoclave, washer-disinfector for automated pre-cleaning, CertoSeal sealing device and water treatment are perfectly matched, installed and maintained by one provider.
What should I do if the instruments are wet after sterilization?
Residual moisture is often caused by an overly full load or too short a drying time. Increase the drying time or activate intensive drying. If the problem persists, report it via steri24.de/help and a technician will get in touch.
May I switch off the drying step to save time?
No, switching off the drying step is not permitted, as it is part of the complete sterilization process. However, the drying intensity can be configured.
What should I do if the device shows an error?
In the case of a water message, first check the tank. For other errors, please fill out the service form at steri24.de/help and describe the error, ideally with a photo of the log. A technician will then get in touch with a solution.
What does an error during the vacuum test mean?
An error during the vacuum test usually indicates that air is flowing into the chamber and that the contact pressure of the door seal needs to be increased or the seal replaced. A quick guide can be found on the inside of the door; if that does not help, report it via steri24.de/help.
The door won't open after the program – what should I do?
A locked door can often be released by switching off and on again, frequently also together over the phone. Please report the problem with a description and photos via steri24.de/help and we will support you.
What warranty and maintenance options are there?
The devices come with a manufacturer's warranty that can be extended by signing a maintenance contract. We offer maintenance and validation on site with free travel. We are happy to tell you the specific terms.
Do I get an instruction in the device?
Yes. An instruction is included during commissioning or initial validation on site. In addition, we offer a free instruction via video chat or phone; on request we train your staff in sterilization.
Does the autoclave have to be in a separate room?
For the installation site, general requirements apply for a suitable, clean reprocessing environment as well as an appropriate power and, if necessary, water supply. We are happy to clarify which solution makes sense in your practice during the consultation.
How do I find the right device for my practice?
The easiest way is via the autoclave configurator: in about 2 minutes you receive a suitable recommendation for the model, size and accessories for your ENT practice. Alternatively, we will prepare a no-obligation quote for you.
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