W&H Lara RIS-311 User manual

RIS-311
Instructions for Use
RIS-311 - ENG - Rev02

Table of contents
Lara XL| Instructions for Use |RIS-311 ENG Rev02 |01/06/2022 |© W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 8
About this manual 8
Use restrictions 9
Safety information 10
Safety warnings 10
Responsibility 11
Getting started 12
Unpacking 12
Handling 15
Product description 16
Installing the sterilizer 20
Operating the sterilizer 24
User interface menu 25
Sterilizer setup 30
User authentication 31
EliTrace (optional) 32
USB pen drive 32
Standby mode 32
Administrator 34
User management 34
Traceability options 35
Hide/Unhide a cycle 35
Managing printers 37
Printer selection (optional) 37
Label printer selection (optional) 37
Label printer usage (optional) 38
Label content description 40
Sterilizer tests 41
Sterilizer performance tests 41
Bowie and Dick test 41
Helix test 45
Vacuum test 47
Sterilization cycles 49
Load maintenance and preparation 49
Prepare the sterilizer 51
Sterilization cycle description 52
Sterilization cycle management 53
Unloading 58
Sterilization cycle report 58
Maintenance 63
Warnings for maintenance operations 63
Ordinary maintenance 64
Monthly or 50-cycle maintenance 66
400-cycle maintenance 69

iv Lara XL| Instructions for Use |RIS-311 ENG Rev02 |01/06/2022 |© W&H Sterilization Srl
800-cycle or biannual maintenance 70
800-cycle maintenance 73
4000 cycle or five-year maintenance 75
Extraordinary maintenance 76
Disposal 77
Diagnostics 78
Errors 78
Troubleshooting 83
Emergency door opening 88
Technical data 91
Sterilization cycles 91
Sterilization cycle phases 96
Technical data 99
Recommendations for validation 100
Diagrams 101
Water quality 102
Accessories, spare parts, consumables 103
Authorized W&H service partners 105
Documentation forms 106
W&H installation check-list 106

Conformity
Lara XL| Instructions for Use |RIS-311 ENG Rev02 |01/06/2022 |© W&H Sterilization Srl 5
CONFORMITY TO EUROPEAN 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
module D1 Annex III.
2012/19/EU Waste Electrical and Electronic Equipment Directive (WEEE).
EN 13060 Small steam sterilizers.
IEC 61010-1 Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
Standards
and
Directives
Description
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: Lara XL sterilizers can be validated in accordance to EN ISO 17665-1.
Note: Every new sterilizer is delivered with a Declaration of Conformity and a
Warranty Card.