Contraindications; Classification; Life Cycle - Smeg BPW4260 User Manual

2.1.1 CONTRAINDICATIONS

Any use other than that described in this manual constitutes misuse.
The manufacturer declines all liability for uses other than those stated above
The device may not be used for processing sanitary aids and medical devices in general the
manufacturers of which have not authorised their treatment in automatic washing and
disinfection units, such as single-use devices. In such cases the Manufacturer also declines all
responsibility for any damage to the said aids and devices.
The device may only be used in the ambient, temperature, altitude and humidity conditions
stated in the "TECHNICAL CHARACTERISTICS", "AMBIENT CONDITIONS" section of this manual.
Reference should be made to the " SAFETY AND PRECAUTIONS FOR USE" section for full details
of the relevant precautions.
2.2

CLASSIFICATION

Bedpan washers for use in hospitals, class IIa medical devices.
Classification in accordance with:
- The classification criteria established by Regulation (EU) no. 2017/745 concerning
medical devices, Annex VIII, Rule 16.
2.3

LIFE CYCLE

LIFE CYCLE [also referred to as "lifetime" in directive 93/42/CEE and "intended lifetime" in MDR 2017/745] of
the device: 10 years or 50000 cycles (whichever is reached first) in normal conditions of use with regular
maintenance at the intervals and with the checks recommended in this manual, performed by technical staff
authorised by the manufacturer.
For a medical device, the life cycle is the period of time during which its characteristics and performance do
not deteriorate to an extent which jeopardises the medical condition and safety of patients and of any third
parties.
From Regulation (EU) 2017/745: "[...] confirming the safety and performance throughout the expected
lifetime of the device. [...]".
User Manual 193909105 rev.04 BPW1260 – BPW4260
.
Page 9 – 107