W&S Lexa MN-111 User manual

MN-111
Instructions for Use
MN-111 W&H Med - ENG - Rev12

Table of contents
MN-111| Instructions for Use |MN-111 W&H Med ENG Rev12 |2019/08/31 |© 2019 W&H Sterilization Srl iii
Conformity 5
Symbols and messages 6
Introduction 7
About this manual 7
Use restrictions 8
Safety information 9
Safety warnings 9
Responsibility 10
Getting started 11
Unpacking 11
Handling 13
Product description 14
Installing the sterilizer 18
Operating the sterilizer 22
User interface menu 24
Sterilizer setup 30
User authentication (optional) 32
USB pen drive 33
Standby mode 34
Administrator 36
User management (optional) 36
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) 43
Label content description 46
Sterilization cycles 47
Load maintenance and preparation 47
Typical loads 49
Prepare the sterilizer 50
Sterilization cycle management 50
Unloading 56
Sterilization cycle report 56
Maintenance 64
Warnings for maintenance operations 64
User maintenance 64
Monthly or 50-cycle maintenance 66
1200-cycle or yearly maintenance 69
Extraordinary maintenance 72
Disposal 73
Diagnostics 74
Errors 74
Troubleshooting 77
Emergency door opening 83

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Technical data 86
Sterilization programs 86
Sterilization program phases 90
Technical data 93
Recommendations for validation 94
Diagrams 95
Water quality 96
Accessories, spare parts, consumables 98
Authorized W&H service partners 101
Documentation forms 102
W&H installation check-list 102

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Conformity
CONFORMITY TO EUROPEAN AND AMERICAN STANDARDS AND
DIRECTIVES
STERILIZER featuring sterilization cycles conform with the following
standards:
Standards
and
Directives
Description
93/42/EEC
Medical Device Directive (MDD).
Medical Device Directive 93/42/EEC for devices class IIb, in
accordance with the Rule 15 – ANNEX IX of the above Directive.
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 (WEEE).
CSA C22.2
No. 61010-
1-12
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
UL 61010-
1:2012
Safety requirements for electrical equipment for measurement,
control and laboratory use, general requirements.
ASME Boiler and pressure vessel code.
EN 13060 Small steam sterilizers.
ANSI/AAMI
ST55:2010
Table-top steam sterilizers.
Standards
and
Directives
Description
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.

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Symbols and messages
SAFETY SYMBOLS USED IN THIS MANUAL
WARNING: Indicates a hazardous situation that, if not avoided, could
result in death or serious injury.
Related to a sterilizer, these warnings indicate hazardous situations
that could result in non-sterile conditions (e.g. non-sterile instruments)
which could lead to fatal personal injury.
CAUTION: Indicates a hazardous situation that, if not avoided, could
result in minor or moderate injury.
SYMBOLS DISPLAYED ON THE PRODUCT
Hot surfaces!
Risk of burns.
Hot steam!
Risk of burns.
Consult the Instructions
for Use for important
cautionary information.
Consult the Instructions
for Use.
Do not dispose of with
normal waste
PROPERTY DAMAGE MESSAGES
Notice: Indicates information considered important, but not hazard-related. Typically to avoid damage to the product.

Introduction
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CONTENTS
This section deals with the following subjects:
About this manual 7
Use restrictions 8
About this manual
FOR YOUR SAFETY AND THE SAFETY OF YOUR PATIENTS
The purpose of this manual is to provide information about MN-111
sterilizers to ensure:
nproper installation and set-up;
noptimal use;
nsafe and reliable operation;
ncompliance with regular maintenance and servicing
requirements
Please carefully read the safety information (see "Safety warnings"
on page9).
OBLIGATIONS WITH REGARD TO THIS MANUAL
This manual is an integral part of the product and accompanies it for
its entire working life. It must be consulted in all situations related
to the life cycle of the product, from its delivery through to
decommissioning. For this reason, it should always be accessible
to operators both online and offline.
Contact customer service in the event the manual is unavailable. If
the device is transferred, always attach the manual for the new
owner.
MANUAL CONTENT
This manual contains the Instructions for Use and for maintenance
of the following sterilizer versions:
nMN-111 100–125 V ac
nMN-111 200–240 V ac
Versions differ only for nominal voltage and maximum current (e.g.
they have the same hydraulic circuit, software menu, sterilization
programs, etc.).
DISCLAIMER
All pictures, graphics and illustrations provided in this manual are
for the comprehension of the text. They are not meant to be an
accurate representation of product details. Thus, they should be
taken as indicative only, and may differ from the actual product.
For any suggestions or remarks please send an email to
[e-mail].
COPYRIGHT NOTICE
Copyright © 2019, W&H Sterilization Srl
All rights reserved in all countries.

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Introduction
All drawings, images and texts contained in this manual are the
property of the manufacturer. Even partial duplication of drawings,
images or text is prohibited.
The information contained in this document is subject to change
without prior notice.
Use restrictions
INTENDED USE
The MN-111 is designed for pressurized steam sterilization of
medical and pouched dental instruments, including dental
handpieces, porous and hollow loads.
Key program features, including sterilization time, temperature and
recommended load type are listed in the following table:
Program Type of Load and
Load weight
Sterilization
Temperature
Sterilization
Time
Drying Time
(recommended)
Pouches
Medium
Load
Instruments and
dental handpieces,
up to 3 lbs (1.4 kg).
270 °F
(132 °C) 4 minutes 25 minutes
Pouches
Large Load
Instruments and
dental handpieces,
up to 6 lbs (2.7 kg).
270 °F
(132 °C)
4 minutes 30 minutes
Wrapped
Cassettes
Instruments and
dental handpieces,
up to 14 lbs (6.4
kg).
270 °F
(132 °C)
4 minutes 40 minutes
Program Type of Load and
Load weight
Sterilization
Temperature
Sterilization
Time
Drying Time
(recommended)
Unwrapped Instruments and
dental handpieces,
up to 18 lbs (8.2
kg).
270 °F
(132 °C)
4 minutes 8 minutes
Low
Temperature
Textiles, up to 4.4
lbs (2 kg), or
instruments and
dental handpieces
requiring low
temperature, up to
5 lbs (2.3 kg).
250 °F
(121 °C)
30 minutes 30 minutes
See "Sterilization programs" on page86 for the full list of key
program features, including sterilization time, temperature, drying
time and recommended load type.
USER QUALIFICATION
The users who may operate the sterilizer are the following.
User
qualification Competences
Head of the
clinic/practice
Legally responsible for:
nthe efficiency of the hygiene protocol in place
nthe sterilization process
nthe operators' training and training documentation
nthe correct operation and maintenance of the equipment
Trained
operators
nRegularly attend the training for operating and using the
sterilizer safely.
nUse the sterilizer according to the Head of the
clinic/practice's instructions.

Safety information
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CONTENTS
This section deals with the following subjects:
Safety warnings 9
Responsibility 10
Safety warnings
THERMAL HAZARDS
nThe chamber automatically begins to heat to
high temperature as soon as the sterilizer is
switched on – risk of burns!
nThe trays and the sterilization load are hot at the
end of each cycle. Use tray or cassette holders
to empty the sterilization chamber.
nAlways wear appropriate PPE during use of the
sterilizer (e.g. gloves for cleaning, maintenance,
etc...).
ELECTRICAL RISKS
nDo not pour water or any other liquids over the
sterilizer (risk of electrical short circuits).
nSwitch off the sterilizer and unplug the mains
cable before inspecting, carrying out
maintenance or servicing the sterilizer.
nEnsure that the power receptacle the sterilizer is
connected to is properly grounded.
nAll electric devices connected to the sterilizer
shall be of Insulation Class II (double insulated)
or higher.
nUse only the power cord provided by the
manufacturer.
IMPROPER USE OF THE STERILIZER
nThe sterilizer must not be used in presence of
explosive or flammable gases, vapors, liquids or
solids.
nThe sterilizer has not been designed for the
sterilization of foodstuff or waste.
nDo not exceed the maximum load weight limits
as specified in this manual (see "Run a
sterilization cycle" on page50).
nDo not drink any water that has been inside the
sterilizer.

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Safety information
TAMPERING
nDo not remove the name plate or labels from the
sterilizer.
nRepairs, maintenance or service must be carried
out by authorized service providers always using
genuine spare parts.
REQUIREMENTS
nAll accessories connected to the sterilizer shall
be FDA cleared.
nIf the sterilizer is connected to a water supply
system, this must be fitted with a backflow
preventing device complying to IEC 61770.
CYBER SECURITY
In order to improve the IT security of the system, a firewall
(iptables) is installed in the system and protects the security of the
device from external attacks.
It is recommended not to leave the machine unattended.
Responsibility
USER RESPONSIBILITY
nThe user is responsible for the proper installation, the correct
use and maintenance of the sterilizer in accordance with these
Instructions for Use.
nThe safety devices of the sterilizer are impaired when the
product itself is not installed, used and serviced in accordance
with these Instructions for Use.
nThe Instructions for Use updated to the latest version is
always available at med.wh.com.
nKeep these Instructions for Use for future reference.
MANUFACTURER RESPONSIBILITY
nThe manufacturer can only accept responsibility for the safety,
reliability and performance of the product when the product
itself is installed, used and serviced in accordance with the
Instructions for Use.
nServicing by unauthorized persons invalidates all claims under
warranty and any other claims.

Getting started
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CONTENTS
This section deals with the following subjects:
Unpacking 11
Handling 13
Product description 14
Installing the sterilizer 18
Operating the sterilizer 22
User interface menu 24
Sterilizer setup 30
User authentication (optional) 32
USB pen drive 33
Standby mode 34
Unpacking
UNPACK THE STERILIZER
CAUTION! Heavy product. The sterilizer must be removed
from the box and transported by two authorized technicians.
Weight: 105.8 lbs (48 kg)

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Getting started
WARNINGS
Notice: Check the external condition of the box and the sterilizer. In
case of any damage, immediately contact the dealer or shipping
agent that has carried out the transport. Keep the packaging for
shipping or transporting the sterilizer in the future.
Note: The packaging of the product is environmentally friendly and can be
disposed of by industrial recycling companies.
CONTENTS OF THE PACKAGING
Sterilizer Trays (four)
Chamber rack Tray holder
Power cord Drain tube

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Getting started
USB pen drive This manual, declaration of
conformity, documentation CD,
warranty card, work test report
ITEMS NOT PROVIDED WITH THE STERILIZER
The following items are not provided:
nWater container to capture waste water during manual tank
draining (volume larger than 1.84 gal (7 l))
nLAN cable for connecting the sterilizer to a network (optional)
See "Accessories, spare parts, consumables" on page98 for a full
list of optional accessories.
Handling
HOW TO RELOCATE THE STERILIZER
Before transport:
nCompletely drain both water tanks (see "Draining the used and
clean water tank" on page72).
nAllow the sterilization chamber to cool down.
nUse original packaging when shipping or transporting the
sterilizer. Replacement packaging materials are available from
Service W&H.

Getting started
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Product description
FRONT VIEW
Part Description
AChamber door
BClean water tank
CDoor locking system
DTouch screen
EService door
FSterilization chamber
GSafety thermostat reset
HHEPA filter
IDoor gasket

Getting started
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COMPONENTS BEHIND THE SERVICE DOOR
Part Description
AMains switch
BUSB port
CEmergency door opening tool
DIdentification label
EUsed water drain port (grey)
FClean water drain port (blue)
GDrain tube release buttons
HPort for emergency door opening tool

Getting started
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REAR VIEW
Part Description
ALAN port (KIT)
BUSB port
CPressure safety valve cover
DUsed water drain (optional)
EWater supply inlet (optional)
FCondenser grid
GPower cord guides
HPower cord socket

Getting started
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CHAMBER ACCESSORIES
Part Description
ATray
BChamber rack. It can host trays or cassettes inserted horizontally or
vertically.

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Getting started
Installing the sterilizer
LOCATION REQUIREMENTS
Notice:
Do not place the sterilizer so that it is difficult to operate the
controls behind the service door. Do not place the sterilizer so that
it is difficult to disconnect the power cord.
Leave the condenser grid (rear side of the sterilizer) free from
anything that might obstruct the air passage.
Surface materials should be water resistant. If sterilization cycles
will be continuous, pay attention to the surrounding materials:
steam can damage them.
The sterilizer must operate in absence of explosive atmospheres.
The sterilizer must operate in a well ventilated room far from
sources of heat and from flammable materials.
Place the sterilizer on a flat and level surface.
Clearance requirements to ensure proper air circulation:
ELECTRICAL CONNECTIONS
All the cables and tubes connected on the rear side of the sterilizer
must be placed far from the condenser grid (e.g. using the available
guides).
Notice:
Use only the cord set provided by the manufacturer.
Ensure that external and internal surfaces are free from moisture or
condensation before connecting to power.
The installation of the sterilizer shall be performed by two
authorized technicians using PPE (Personal Protective Equipment)
according to applicable standards.
The electrical power supply of the sterilizer must fulfill all applicable
standards in the country of use, and must comply with the data
label on the back of the sterilizer.

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Getting started
WATER CONNECTIONS
The sterilizer clean water tank can be filled manually by the user or
automatically with a water supply system. The water supply
system must deliver demineralized or distilled water meeting the
specifications listed in these instructions. Do not add any
chemical/additive to the water.
The manufacturer’s warranty is void if the sterilizer was used with
water containing either chemical additives, or contaminant levels
exceeding those listed in these instructions. See "Feed water
specifications (EN 13060)" on page96 and "Feed water
specifications (ANSI/AAMI and AAMI TIR34)" on page97.
Notice: The maintenance of the external water filling system must
be done in exact accordance with the Instructions for Use given
with the relevant system.
WATER TANKS
At every cycle the sterilizer uses new fresh water and, at the end of
the cycle, discharges it. Thus, the sterilizer is fitted with two water
tanks : the clean water tank and the used water tank.
For this reason is necessary to periodically fill the clean water tank
and draining the used water tank.
FILLING THE CLEAN WATER TANK
Notice:
Before carrying out the following steps, make sure that the sterilizer
has completed the cycle in progress.
Always wear appropriate PPE during use of the sterilizer (e.g. gloves
for cleaning, maintenance, etc...).
1If switched-off, switch the sterilizer
ON. If the clean water tank is
almost empty, an alert appears on
the display.
2Open the chamber door.

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Getting started
3Fill the clean water tank with a
water container (app. 1.7 gal (6.4
l)).
Notice: The water must be
demineralized or distilled meeting
the specifications listed in these
instructions (see "Feed water
specifications (EN 13060)" on
page96 and "Feed water
specifications (ANSI/AAMI and AAMI
TIR34)" on page97.). Do not add
any chemical / additive to the
water.
Notice: Take care not to pour the
clean water out of the tank.
4Once the clean water tank is
almost full, an audible tone sounds;
stop filling.
DRAINING THE USED AND CLEAN WATER TANKS
Notice:
Before carrying out the following steps, make sure that the sterilizer
has completed the cycle in progress.
Always wear appropriate PPE during use of the sterilizer (e.g. gloves
for cleaning, maintenance, etc...).
1If the used water tank is almost full,
an alert appears on the display.
-
2Open the service door at the front of
the sterilizer.
3Put a container (1.84 gal (7 l) min)
below the sterilizer and insert into
it the free end of the drain tube.
4Plug the other end of the drain tube
into the drain connector until it
clicks. Make sure that the
connector is firmly engaged.
Use left connector (blue, A) for the
clean water and the right connector
(grey, B) for the used water.
5Let the water flow from the tank
completely.