W&H Med MN-111 User manual

MN-111
Instructions for Use
MN-111 Med - ENG - Rev14

Table of contents
Lexa| Instructions for Use |MN-111 Med ENG Rev14 |03/04/2023 |© W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 8
About this manual 8
Use restrictions 9
Safety information 12
Safety warnings 12
Responsibility 14
Getting started 15
Unpacking 15
Handling 18
Product description 19
Installing the sterilizer 23
Operating the sterilizer 27
User interface menu 28
Sterilizer setup 34
ioDent 35
User authentication (optional) 35
USB pen drive 36
Standby mode 37
Administrator 38
User management (optional) 38
Traceability options (optional) 39
Hide/Unhide a cycle 40
Managing printers 41
Printer selection (optional) 41
Label printer selection (optional) 41
Label printer usage (optional) 42
Label content description 44
Sterilization cycles 45
Load maintenance and preparation 45
Typical loads 47
Prepare the sterilizer 47
Sterilization cycle management 48
Unloading 53
Sterilization cycle report 53
Maintenance 58
Warnings for maintenance operations 58
User maintenance 58
Monthly or 50-cycle maintenance 60
1200-cycle or yearly maintenance 63
Extraordinary maintenance 66
Disposal 67
Diagnostics 68
Errors 68
Troubleshooting 73

iv Lexa| Instructions for Use |MN-111 Med ENG Rev14 |03/04/2023 |© W&H Sterilization Srl
Emergency door opening 78
Technical data 81
Sterilization programs 81
Sterilization program phases 86
Technical data 90
Recommendations for validation 91
Diagrams 92
Water quality 93
Accessories, spare parts, consumables 94
Authorized W&H service partners 96
Documentation forms 97
W&H installation check-list 97

Conformity
Lexa| Instructions for Use |MN-111 Med ENG Rev14 |03/04/2023 |© W&H Sterilization Srl 5
CONFORMITY TO EUROPEAN AND AMERICAN REGULATIONS,
STANDARDS AND DIRECTIVES
Sterilizer conforms with the following Regulations, Standards and
Directives:
Standards
and
Directives
Description
Medical Device Regulation (MDR) / Regulation (UE) n. 2017/745
for medical devices. Class IIb devices, in accordance with the Rule
16 – ANNEX VIII of the above Regulation
For Device in compliance with Machinery Directive (2006/42/EC),
Low Voltage Directive (2014/35/EU) and Electomagnetic
Compatibility Directive (2014/30/EU)
2014/68/EU
Pressure Equipment Directive (PED) / Directive 2014/68/EU (PED
– Pressure Equipment Directive) for every sterilization chamber
designed and manufactured in conformity to the ANNEX 1 and to
the procedure described in the moduleD1 Annex III
2012/19/EU Waste Electrical and Electronic Equipment Directive (WEEE)
CSA C22.2 No.
61010-1
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements
UL 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements
ASME Boiler and pressure vessel code
EN 13060 Small steam sterilizers
Standards
and
Directives
Description
ANSI/AAMI
ST55
Table-top steam sterilizers
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements
IEC 61010-2-
040
Safety requirements for electrical equipment for measurement,
control and laboratory use; particular requirements for sterilizers
and washer-disinfectors used to treat medical materials
IEC 61326-1 Electrical equipment for measurement, control and laboratory use
- EMC requirements; general requirements
IEC 61770 Electric appliances connected to the water mains - Avoidance of
backsiphonage and failure of hose-sets
Note: every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.