LiNA PRO13-003-17 User manual

LINA ENG - Rev. 5
Posizione logo
Instructions for use
PRO13-003-17
PRO13-003-

Symbols displayed on the product and/or used in this manual:
WARNING!
Risk of injury
ATTENTION!
To prevent damage occurring
General explanations,
without risk to persons or objects
HOT SURFACES!
Risk of burns
HOT STEAM!
Risk of burns
Call service
Thermo washer
disinfectable
Consult instruction for use Do not dispose of
with normal waste
Symbols

Contents
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1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
. Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3. Safety advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4. Installation and start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5. Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6. Running a sterilization cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7. Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
8. Troubleshooting, alarms and messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
9. Recycling and disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
ANNEXES
1 Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Maintenance of dental handpieces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
3 Sterilization load preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
4 Bowie & Dick test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
5 Helix test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
6 Vacuum test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
7 Water quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
8 Example of a cycle data report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
9 Accessories and spare parts
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
64
10Helix test documentation form
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
70
11
W&H Installation
check
-
list
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7

1. Introduction
For your safety and the safety of your patients
The purpose of this manual is to provide you with information about LINA sterilizers to ensure:
•proper installation and set-up;
•optimal use;
•safe and reliable operation;
•compliance with regular maintenance and servicing requirements.
4
Intended use of the product
Small steam sterilizers are widely used for medical purposes, e.g. in general medical practices, dentistry, facilities for personal
hygiene and beauty care and also veterinary practices. They are also used for materials and equipment, which are likely to come into
contact with blood or body fluids, e.g. implements used by beauty therapists, tattooists, body piercers and hairdressers.
The devices is intended for professional use only by trained people.
About this manual
This manual contains the Instructions for Use of the W&H sterilizers LINA PRO13-003-17 and LINA PRO13-003- ,
hereinafter referred to as LINA 17 and LINA .
All drawings, images and texts contained in this manual are the property of the manufacturer.
All rights reserved. Even partial duplication of drawings, images or text is prohibited.
The information contained in this document is subject to change without prior notice.
Responsibility of the manufacturer
The 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.
Servicing by unauthorized persons invalidates all claims under warranty and any other claims.
Please carefully read the safety information in Chapter 3!

Qualifications of the users
There are two types of users who may operate the sterilizer:
The Advanced user is the head of the clinic/practice, who is legally responsible for the efficiency of the hygiene protocol in place as
well as the sterilization process. He/she is also responsible for the USERS’ training and the correct operation and maintenance of the
equipment.
The Users are the persons who use the sterilizer according to the ADVANCED USER’s instructions. They must be trained in operating
the sterilizer and in its safe use. Training must be regular and evidence of the understanding shall be recorded.
Conformity to European Standards and Directives
Medical Device Directive 93/4 /CEE for devices class IIb, in accordance with the Rule 15 – ANNEX IX of the above Directive.
Directive PED 014/68/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.
See the Declaration of Conformity and the Warranty Card in the enclosed documents.
Introduction
5

. Unpacking
If the sterilizer comes from a cold location, wait until all external and internal surfaces
are free from moisture before switching it ON.
The sterilizer must be removed from the box and transported by two people.
Weight: LINA 17: 39 kg
LINA : 40 kg
Check the external conditions of the box and the sterilizer. In case of any damage,
immediately contact your dealer or the shipping agent that has carried out the
transport.
Open the front door.
All the accessories are in the sterilization chamber.
Remove all items except the trays and the tray rack.
6
The packaging of the product is environmentally friendly and can be disposed of by
industrial recycling companies.
However, we recommend to keep the original packaging should you ever have to ship
or transport the sterilizer.

Contents of the package
Tray (3 pieces total)
Reversible rack
Tray holder
Drain tube
Mains cable
Funnel
Wall spacer
7
USB pen drive (only if the USB
option is installed)
Fast guide
Declaration of conformity
Documentation CD
Warranty card
Works tests report
Maintenance sheet

3. Safety advice
8
•The user is responsible for the proper installation, the correct use and maintenance of the sterilizer in accordance with the
instructions listed in this manual.
•The sterilizer has not been designed for the sterilization of foodstuff or waste.
•The sterilizer must not be used in presence of explosive or flammable gases, vapours, liquids or solids.
•The chamber is automatically heated up to high temperature as soon as the sterilizer is switched on – risk of burns!
•Ensure that the socket the mains cable is connected to is properly grounded.
•The trays and the sterilization load will be hot at the end of each cycle. Use tray or cassette holders to empty the
sterilization chamber.
•Do not exceed the maximum load weight limits as specified in this manual (see Chapter 6).
•Do not remove the name plate or any label from the sterilizer.
•To avoid electrical short circuits, do not pour water or any other liquids over the sterilizer.
•Use only the power cord set provided by the manufacturer.
•Switch off the sterilizer and unplug the mains cable before inspecting, carrying out maintenance or servicing the sterilizer.
•All electric devices connected to the sterilizer shall be of Insulation Class II (double insulated) or higher.
•If the sterilizer is connected to a water supply system, this must be fitted with a backflow preventing device complying to
IEC 61770.
•Repairs, maintenance or service must be carried out by service technicians authorized by the manufacturer and using
genuine spare parts only.
•In case of transport:
–Completely drain both water tanks (see section “Water Tanks” in Chapter 4).
–Allow the sterilization chamber to cool down.
–Use original or appropriate packaging.

4. Installation and start-up
9
Required minimum clearances
Back side: 50mm
Right and left sides: 10 mm
Upper side: As required for filling the water tank, 50 mm minimum
Placement
Place the sterilizer on a flat and level surface, far from sources of heat and from flammable materials.
Do not place the sterilizer so that it is difficult to open the service door and operate on the controls in it.
Do not place the sterilizer so that it is difficult to disconnect the power supply plug.
Place the sterilizer in a well ventilated room.
If installed in a cabinet, this shall be provided with an opening of at least 00x150 mm on the rear side.
The sterilizer must not be operated in presence of explosive atmospheres.
Electrical connection
The electrical power supply to the sterilizer must fulfil all applicable standards in the country of use,
and must comply with the data label on the back of the sterilizer.
Use only the cord set provided by the manufacturer.
Connect the cord set to the socket provided in the back of the sterilizer.
Connect the mains cable to a wall outlet with the following characteristics:
•Single - phase 00 - 40 V, 50/60 Hz - 10A, on a dedicated circuit;
•Overvoltage category = II;
•Protected by a suitable circuit breaker and a residual-current device. All protection devices must be
certified according to applicable standards;
•Maximum current absorbed by the sterilizer: 10A;
•A grounded connection is essential.

Water tanks
Filling the clean water tank
•Switch the sterilizer ON
•Slide the tank cover to the right to access the clean water tank inlet.
•Remove the cap from the tank inlet;
•Insert the funnel and fill the water tank with app. 4 litres of distilled or demineralized water;
•Once the clean water tank is almost full, an audible tone will sound; stop filling;
•Place the cap to close the tank;
•Slide the tank cover back into its original position.
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Draining the used and clean water tank
•Open the service door at the front of the sterilizer.
•Put a container (4 litres min) below the sterilizer and insert into it the free end of the drain tube.
•Insert the drain tube into the left connector (grey) for the used water, or into the right connector
(blue) for the clean water.
•Let the water flow from the tank completely.
•Press the push-button on top of the quick connector to dislodge the drain tube.
Use only distilled or demineralized water as described in ANNEX 7.
Do not add any chemical / additive to the water.
Clean water drain (blue)
Used water drain (grey)