Smeg BPW1260 User manual

BPW1260
BPW –BEDPAN WASHERS –Hospital sector
USER MANUAL
TRANSLATION OF THE ORIGINAL INSTRUCTIONS

User Manual
193909105 rev.02
BPW1260
Page 2 –93
Device Manufacturer and CE mark
[ Device Manufacturer and CE mark ]

User Manual
193909105 rev.02
BPW1260
Page 3 –93
Table of Contents
1 INITIAL INSTRUCTIONS .............................................................................................................................. 7
2 INTENDED PURPOSE AND CLASSIFICATION............................................................................................... 8
2.1 INTENDED PURPOSE.......................................................................................................................... 8
2.1.1 CONTRAINDICATIONS................................................................................................................ 9
2.2 CLASSIFICATION................................................................................................................................. 9
2.3 LIFE CYCLE.......................................................................................................................................... 9
2.4 STANDARD EN ISO 15883 ................................................................................................................ 10
2.5 DEFINITION: “RESPONSIBLE BODY” IN RELATION TO THE DEVICE.................................................. 11
2.6 INTENDED USER AND SUPERUSER................................................................................................... 11
3 PRESENTATION........................................................................................................................................ 12
4 PRODUCT CONFIGURATION .................................................................................................................... 13
4.1 Optional components...................................................................................................................... 15
4.1.1 BPW-2B –Optional accessory which configures the device to wash 2 bedpans .................... 16
4.1.2 BPW-DRY –Steam removal system......................................................................................... 16
4.1.3 BPW-DRAINFLOOR –Optional accessory for adapting the device for connection to a floor drain
17
4.1.4 BPW-P1H –Optional P1 detergent dispensing system ........................................................... 18
4.1.5 BPW-BINTANK –Optional tank to collect any detergent spills ............................................... 18
4.1.6 BPW-232PRINT –Optional RS232 port for remote printer connection .................................. 19
4.1.7 BPW-LANI –Optional communication port unit: LAN and RS232........................................... 19
4.1.8 BPW-PRINTE2 –Optional cycle report and machine parameters printer............................... 20
4.1.9 BPW-EC-1 –Set of components for connection of the device to single-phase power ........... 21
4.1.10 BPW-EC-3 –Set of components for connection of the device to single-phase power ........... 22
5 SAFETY AND PRECAUTIONS FOR USE ...................................................................................................... 23
5.1 KEY TO THE SYMBOLS USED IN THE MANUAL AND ON THE DEVICE............................................... 23
5.2 GENERAL WARNINGS....................................................................................................................... 25
5.2.1 WARNINGS CONCERNING CONNECTION TO AN IT NETWORK................................................ 27
5.2.2 WARNINGS ASSOCIATED TO EXTERNAL FACTORS, ELECTROMAGNETIC FIELDS..................... 27
5.3 WARNINGS FOR HANDLING THE DEVICE......................................................................................... 28
5.4 PRECAUTIONS FOR ACCESSING AND REUSING THE DEVICE AFTER AN INCOMPLETE CYCLE AND FOR
ACCESSING THE DEVICE AT END-OF-LIFE .................................................................................................... 29
6 REMOVING THE PACKAGING AND PREPARING FOR HANDLING............................................................. 30
6.1 POSITIONING AND FIXING THE DEVICE ........................................................................................... 31
6.1.1 FIXING TO THE WALL ............................................................................................................... 31
6.1.2 FIXING TO THE FLOOR ............................................................................................................. 32
7 CONNECTING TO THE ELECTRICITY AND WATER SYSTEMS..................................................................... 34
7.1 ACCESS TO CONNECTIONS............................................................................................................... 34

User Manual
193909105 rev.02
BPW1260
Page 4 –93
7.2 CONNECTING THE DRAIN TRAP....................................................................................................... 35
8 COMMISSIONING .................................................................................................................................... 37
8.1 USINGDETERGENTS ......................................................................................................................... 38
8.1.1 LIQUID SUCTION SYSTEM –REPLACING AN EMPTY JERRY CAN.............................................. 38
9 BASIC OPERATION ................................................................................................................................... 40
9.1 CONTROL AREA................................................................................................................................ 40
9.2 BPW1260 BUTTONS......................................................................................................................... 41
9.3 DISPLAY AND ICONS ........................................................................................................................ 42
9.4 WITH CYCLE PRESELECTED –INFORMATION ABOUT PROGRAM PARAMETERS............................. 45
9.5 SELECTING A PROGRAM .................................................................................................................. 45
9.6 STARTING THE PROGRAM ............................................................................................................... 46
9.7 PROGRAM RUNNING....................................................................................................................... 46
9.7.1 INTERRUPTING THE CURRENT PROGRAM............................................................................... 47
9.8 PROGRAM COMPLETED................................................................................................................... 47
9.9 PROGRAM COMPLETED WITH ANOMALIES –WARNINGS.............................................................. 49
9.10 ALARMS –SERIOUS ANOMALIES..................................................................................................... 50
10 SETUP and PARAMETER SETTING PROCEDURES..................................................................................... 50
10.1 Accessing the menus ....................................................................................................................... 52
10.2 Access to the Setup and dependent headings ................................................................................ 53
10.3 SETTING THE TIME –Clock Menu.................................................................................................... 57
10.4 SETTING THE DATE –Date Menu..................................................................................................... 58
10.5 DRY HOUR COUNTER –DryH........................................................................................................... 58
10.6 ABSOLUTE HOUR COUNTER –Count............................................................................................... 58
10.7 PROGRAM ENABLING –PR EN......................................................................................................... 59
10.8 SETTING A0–Setup A0..................................................................................................................... 59
10.9 RESET ............................................................................................................................................... 60
10.9.1 MC –RESET –CONFIGURATION .............................................................................................. 60
10.9.2 ME –RESET –EQUIPMENT ...................................................................................................... 60
10.9.3 DF –Dryer filter –Relative decremental counter.................................................................... 61
10.9.4 RM –Residual Maintenance Cycles, number of cycles remaining before maintenance –
Counter 61
10.10 MEMORY AND PRINTOUT............................................................................................................ 62
10.11 EDITING CUSTOM PROGRAMS .................................................................................................... 64
11 RECOMMENDED DETERGENTS AND IMPORTANT NOTICES.................................................................... 65
12 PREPARING THE LOAD FOR THE WASHING AND DISINFECTION CYCLE .................................................. 67
12.1 LOAD SUPPORTS.............................................................................................................................. 67
12.1.1 STANDARD SUPPORT R-1B2P-01............................................................................................. 68
12.1.2 SUPPORT FOR 2 BEDPANS R-2B -01......................................................................................... 69

User Manual
193909105 rev.02
BPW1260
Page 5 –93
13 ALARMS, WARNING AND DEVICE RESPONSE TO BLACKOUTS ................................................................ 70
13.1 WARNINGS....................................................................................................................................... 71
13.1.1 WARNING TABLE ..................................................................................................................... 72
13.2 ALARMS ........................................................................................................................................... 73
13.2.1 ALARM TABLE .......................................................................................................................... 75
14 CLEANING AND MAINTENANCE .............................................................................................................. 78
14.1 PRELIMINARY PRECAUTIONS........................................................................................................... 78
14.2 CLEANING THE DEVICE .................................................................................................................... 78
14.3 IF THE DEVICE IS TO BE OUT OF USE ............................................................................................... 79
14.3.1 FOR A FEW HOURS .................................................................................................................. 79
14.3.2 FOR 24 HOURS OR MORE ........................................................................................................ 79
14.3.3 FOR 10 DAYS OR MORE ........................................................................................................... 79
14.4 REUSING THE DEVICE AFTER A PERIOD OUT OF USE ...................................................................... 80
14.5 MAINTENANCE AND ROUTINE CHECK TIME INTERVALS................................................................. 81
14.5.1 DAILY........................................................................................................................................ 81
14.5.2 WEEKLY.................................................................................................................................... 81
14.5.3 EVERY SIX MONTHS ................................................................................................................. 81
14.5.4 EVERY YEAR.............................................................................................................................. 81
14.6 TROUBLESHOOTING ........................................................................................................................ 82
15 INSTALLATION.......................................................................................................................................... 83
15.1 TECHNICAL CHARACTERISTICS......................................................................................................... 83
15.1.1 Water connections .................................................................................................................. 83
15.1.2 ELECTRICAL CONNECTIONS ..................................................................................................... 84
15.1.2.1 50 Hz version ....................................................................................................................... 84
15.1.2.2 60 Hz version ....................................................................................................................... 84
15.1.3 AMBIENT CONDITIONS............................................................................................................ 84
15.1.4 WEIGHT OF DEVICES AND STAINLESS STEEL MATERIALS........................................................ 85
15.1.5 APPLIED DIRECTIVES AND STANDARDS................................................................................... 85
15.2 PRODUCT DIMENSIONS AND DRAIN CONNECTION ........................................................................ 86
15.2.1 WALL DRAIN ............................................................................................................................ 86
15.2.2 FLOOR DRAIN........................................................................................................................... 87
15.2.3 CONNECTIONS AREA –ELECTRICITY AND WATER................................................................... 88
15.2.4 CONNECTIONS TO THE DEVICE................................................................................................ 89
15.3 ELECTRICAL SYSTEM REQUIREMENTS ............................................................................................. 91
15.3.1 Power cable ............................................................................................................................. 91
16 WATER CONNECTION REQUIREMENTS................................................................................................... 92
16.1.1 WATER INTAKE ........................................................................................................................ 92
16.2 WATER DRAIN REQUIREMENTS....................................................................................................... 92

User Manual
193909105 rev.02
BPW1260
Page 6 –93
17 AFTER-SALES SERVICE AND MANUFACTURER CONTACT DETAILS .......................................................... 93
193909105
02
18/01/2023
Updating of manual for publication.
193909105
01
12/10/2022
Revision with inclusion of CE0051 mark on front cover, clarification of post-
installation electrical connection, updating of preparation of system
preparation and interface instructions.
193909105
00
09/03/2022
First issue
Code
Rev.
Date
Notes

User Manual
193909105 rev.02
BPW1260
Page 7 –93
1INITIAL INSTRUCTIONS
READ THIS USER MANUAL WITH CARE
This manual is an integral part of the device. Take good care of it and keep it to hand throughout the device’s life cycle.
This manual and all the information it contains must be read carefully before using the device. Failure to read, any
misunderstanding or incorrect interpretation of the instructions provided in this manual may lead to misuse of the
device, put the operator at risk and impair the device’s performance.
Installation, maintenance and any repairs must be carried out by authorised technical staff.
Apart from leading to forfeiture of warranty cover, repairs performed by unauthorised staff may
put the user’s safety at risk.
Any components must always be replaced with genuine spare parts.
Use of the device in breach of the instructions provided by the manufacturer may jeopardise the
specified protection level (safety of the device) and the warranty cover for it (ref. IEC 61010-1).
This device’s performance and safety have been tested with reference to the chemical products
recommended by the Manufacturer.
The Manufacturer declines all liability for uses other than those stated above.
Consumables (detergents, air filters, thermal printer paper, etc.) are not covered by the
warranty, except for any manufacturing defects.
The Warranty does not cover any parts found to be faulty due to negligent or careless use,
improper use, failure to comply with the device’s operating instructions, incorrect installation or
maintenance, maintenance or repairs performed using by unauthorised staff or repairs made
with non-genuine parts, damage during transport, or any circumstances in which the device’s
defects cannot be traced back to manufacturing faults. Any work relating to installation and
connection to the intake and drain systems, and the maintenance work described in the user
manual, are also excluded from the Warranty.
Any accessories may not be installed on the device by the user; this must be done by authorised
technical staff.
To request informative documentation to accompany accessories: contact the authorised dealer
and/or the authorised after-sales service, using the contacts provided in this manual (ref.
IEC61010-2-040).
The information in this manual is provided for guidance only. The contents and the equipment described may be subject
to change without notice. Illustrations and the colours used in photographs, drawings and the forms which reproduce
the display are purely guideline, and intended to ensure that the user correctly understands the operating concepts
described in the text.

User Manual
193909105 rev.02
BPW1260
Page 8 –93
2INTENDED PURPOSE AND CLASSIFICATION
2.1 INTENDED PURPOSE
DESCRIPTION OF THE PRODUCT: Washing and thermal disinfection device for the treatment of sanitary aids
used for human waste, such as bedpans, urine bottles and similar containers.
SERIES
Key characteristics
BPW1260
Free-standing bedpan washer of 60 cm, with manually operated bottom-hinged door
INTENDED PURPOSE:
treatment of sanitary aids used to contain human waste, in use within hospitals and or care
homes, by means of thermal disinfection cycles, to prevent the spread of infectious agents
which are a threat to both hospital staff and the final patient.
The device has been validated in accordance with the ISO 15883-1, 15883-3 and ISO 15883-5
standards (see declaration of conformity for the versions of the standards applied and the
year of publication).
The device does not sterilise the load.
The washing support contains and positions the load and determines type of instrument
which can be processed in a cycle. (The device is supplied as standard without washing
supports; contact the manufacturer for advice about the supports best suited to your needs).
Only washing supports recommended and supplied by the manufacturer as compatible with
the devices concerned may be used.
Sanitary aid manufacturers’ instructions should always be followed when choosing the most
appropriate disinfection program.
The operator’s own knowledge, especially of the table of programs installed in the device
and the type of load for processing, is essential for selection of the correct treatment cycle:
the device offers various cycles depending on the different types of load and the washing
intensity required. Moreover, different A0values and different peak temperature values for
the thermal disinfection process can be set.
It is essential to check the compatibility of the load for treatment with the specific washing
cycle chosen, in terms of the maximum temperatures reached and the chemicals used.

User Manual
193909105 rev.02
BPW1260
Page 9 –93
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.02
BPW1260
Page 10 –93
2.4 STANDARD EN ISO 15883
The standard of reference for the performance of a washer disinfector is EN ISO 15883.
Point 6 of standard 15883-1 not only states that the manufacture must ensure the compliance of the device as supplied
but also requires it to perform additional checks on the device as installed in a process referred to overall as
“validation”. The validation process of the installed device must be performed by the user (responsible body).
VALIDATION
The validation process for a thermal disinfection device under EN ISO 15883-1 involves 3 different phases.
1. Installation Qualification –IQ
2. Operational Qualification –OQ
3. Performance Qualification –PQ
Installation Qualification
IQ –Process of obtaining and documenting evidence that equipment has been provided and installed in accordance
with its specification.
Operational Qualification
OQ –Process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures.
Performance Qualification
PQ –Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with
operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product
meeting its specification.
Note on performance qualification
Performance qualification must be carried out after completion of installation and operational qualification.
Performance qualification must be carried out whenever new or modified objects are placed in the device for washing
and disinfection, or new load systems are used, unless proof is provided that they are equivalent to an approved
reference load or an object or load system already validated in the past.
Performance qualification must be carried out when new process parameters (including process chemicals) are adopted.
Operational qualification should be repeated at set intervals to provide regular verification of the device’s operation.
Repetition of performance qualification for each device every year is recommended.
WARNING –USE OF PROBES FOR VALIDATION
The device has a physical port for the insertion of probes. The port can only be accessed by authorised
engineers, in accordance with the procedure established by the Manufacturer.
If probes are utilised by the user or other parties, the use of wireless probes (datalogger or similar) is
recommended.