For over 4 decades, over 40,000 Deko units have been delivered to over 40 countries.
This DEKO Lifespan Guideline is intended to identify and eliminate any potential risks, and recommend appropriate actions, to maximize the lifespan of the DEKO brand washer-disinfectors and the drying cabinets considering the operational and performance-related aspects of the machine over the entire life cycle.
The below is just a guide, Rhima have Deko’s still in use that are over 20 years old and performing to Australian standards.
Where;
Useful life means a period specified by the manufacturer during which the characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user are compromised during the lifetime of the device, as indicated by the manufacturer when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained by the manufacturer’s instructions (as defined in the Medical Device Regulation (MDR) EU 2017/745, Annex 1, Chapter 1, bullet 6).
Expected Service life means a period specified by the manufacturer during which the operational and performance qualification-related topics of the medical equipment are expected to remain on a level making it feasible and cost-effective to maintain the equipment.
Guaranteed service life means a period during which the deliveries of spares can be secured.
We want to emphasise that the useful life is the minimum period during which we expect the machine’s essential performance to remain on a sufficient level considering the intended use. However, the utilisation rate, conformity to preventive maintenance program (or the lack of it), and many other factors, which we as a manufacturer have no control over, might shorten the total lifespan of the equipment. Vice versa, any machine that is only randomly used might have a lifespan of ~20 years, even longer.
Our extensive experience gained over the years, the existing install base of thousands of machines, and service statistics show that the majority of our installations exceed the aforesaid useful life. However, we will not give any binding legal guarantees that the equipment will last beyond its useful life as it depends too much on external factors which we have no control over (as indicated above). We request users pay special attention to the performance of the equipment as the end of the defined useful life approaches, and especially if it has been exceeded, to avoid any risks related to potentially worn-out components.
We want to secure the deliveries of spares for legacy models for 10 years from the date of manufacture (ref: guaranteed service life). On many occasions, we can supply spares beyond the guaranteed service life but because of the fast-paced R&D and limited product life of particularly electrical components, guaranteed delivery of spares is restricted to 10 years.
As a manufacturer of the DEKO brand washer disinfectors and the drying cabinets, are obliged by the MDD/MDR to define a preventive maintenance program, which again the users are obliged to follow. In addition to the preventive maintenance program, we highly recommend the users to:
- secure the operational and performance-related issues of the machine by validation according to local requirements during the installation and commissioning of the machine using worst-case scenario loads;
- perform re-validation on regular-basis and
- implement a routine control procedure according to local requirements to prove the essential requirements along with operational and performance qualification criteria are met in daily use.