NSK IClave Plus Manuel utilisateur

Rev. 1

Date: June 2015

plus

Water Steam Sterilizer –Class B

OPERATION MANUAL

The iClave Plus complies fully with EN13060, and the built-in parameters have properly set by the manufac-

turer in order to warranty effective sterilization if proper loading conditions are followed.

Please, read carefully this manual before using the machine; an improper utilization of the sterilizer should

carry on defective sterilization with unattended consequences.

In case of doubt or questions, please call the agent.

Thanks for the confidence given.

No portion of this publication can be printed, transmitted, rewritten, stored in a data recovery system,

translated in any foreign or computer language, in any form or through any devices, without written

consent by NSK.

Information in this manual is subject to change without any warning or prior notice by NSK and does not represent a

commitment for the vendor.

is a trademark of NSK

info@nsk.fr

www.nsk.fr

DENTAL X S.p.A.

Via Marzotto 11

36031 Dueville (VI) Italy

Tel. +39 0444 367400

Fax +39 0444 367436

e-mail: den[email protected]

http://www.dentalx.it

TABLE OF CONTENTS

1. GENERAL......................................................................................................................................2

1.1 INTRODUCTION ..................................................................................................................................2

1.2 CONFORMITY TO EUROPEAN DIRECTIVES.....................................................................................2

1.3 PACKAGE DIMENSIONS AND WEIGHT.............................................................................................3

1.4 UNPACKAGING ...................................................................................................................................3

2. FAMILIARIZATION........................................................................................................................4

2.1 OVERALL DIMENSIONS......................................................................................................................4

2.2 USABLE SPACE IN THE CHAMBER...................................................................................................4

2.3 SAFETY FEATURES............................................................................................................................5

2.4 PRECAUTIONS....................................................................................................................................6

2.5 FRONT AND REAR VIEW....................................................................................................................7

2.6 STANDARD ACCESSORIES ...............................................................................................................8

2.7 TECHNICAL SPECIFICATIONS...........................................................................................................8

2.7.1 Environment operating conditions .......................................................................................8

3. INSTALLATION.............................................................................................................................9

3.1 BASIC REQUIREMENTS .....................................................................................................................9

3.2 GETTING STARTED ..........................................................................................................................10

3.3 NOTES ABOUT ALTITUDE COMPENSATION..................................................................................11

4. OPERATING INSTRUCTIONS....................................................................................................12

4.1 FRONT PANEL COMMAND/SIGNALING...........................................................................................12

4.2 USB MEMORY CONNECTION...........................................................................................................14

4.3 RUNNING A STERILIZAZION CYCLE...............................................................................................15

4.3.1 Available sterilization cycles ..............................................................................................15

4.3.2 Starting a sterilization cycle ...............................................................................................16

4.4 STOPPING THE CYCLE ....................................................................................................................17

4.5 TOPPING UP AND DRAINING THE WASTE WATER TANK ............................................................18

4.5.1 Topping up the main tank ..................................................................................................18

4.5.2 Draining the waste water tank............................................................................................18

5. PROGRAMMING .........................................................................................................................19

SETUP MENU.............................................................................................................................................19

6. MAINTENANCE...........................................................................................................................21

6.1 AUTOMATIC PERIODIC CLEANING CYCLE ....................................................................................21

6.2 CLEANING THE INSTRUMENTS BEFORE THE STERILIZATION ...................................................21

6.3 CLEANING/REPLACING THE WATER INLET FILTER.....................................................................22

6.4 REGULAR STERILITY TESTS...........................................................................................................22

6.4.1 Porous load test (B&D)......................................................................................................22

6.4.2 Vacuum Test......................................................................................................................22

7. TROUBLESHOOTING.................................................................................................................23

7.1 INITIAL AUTO-TEST ..........................................................................................................................23

7.1.1 Water quality check ...........................................................................................................23

8. ALARMS ......................................................................................................................................24

8.1 GENERAL...........................................................................................................................................24

8.2 WARNING MESSAGES .....................................................................................................................24

8.3 PRE-WARNING ALARMS..................................................................................................................25

8.4 ABORTED CYCLE ALARMS..............................................................................................................25

8.5 CLASS B ADDITIONAL ALARMS.......................................................................................................26

9. CONNECTIONS...........................................................................................................................27

9.1 CONNECTION TO AN EXTERNAL PRINTER....................................................................................27

9.2 CONNECTION TO A COMPUTER.....................................................................................................28

APPENDIX : SERVICE BOOK

1. GENERAL

1.1 INTRODUCTION

Object of this manual is to supply instructions for the operators in order to allow:

correct installation

proper maintenance of the sterilizer

The machine must be installed and operated according to the procedures described in this manual.

The user is responsible for what concerns the fulfilment in the legal subject concerning installation and opera-

tion of the sterilizer.

If the machine is not correctly installed and operated or the appropriate maintenance is not carried out, the

manufacturer cannot be considered responsible for any possible breaks and malfunctions.

Please, check for the packing integrity and no evident damages or missing parts (see delivery note).

IN CASE OF DAMAGES OR MISSING PARTS, PLEASE IMMEDIATELY INFORM AND IN DETAIL

THE FORWARDER, NSK AND ITS AREA AGENT.

1.2 CONFORMITY TO EUROPEAN DIRECTIVES

The sterilizer manufactured by Dental X for NSK complies with the electromagnetic compatibility standards in

conformity with the Medical Device Directive 93/42/CEE and with the norm EN 13060.

This equipment has been developed and manufactured using high quality material that can be recycled and

reused.

This symbol means that electrical and electronic equipment, at the end of their lifetime,

must be disposed separately from the household waste. Dispose this unit by carrying it to

the local collection/disposal centre. Sanctions are applied in case the regulations concern-

ing waste disposal are not met.

Help us to preserve the environment in which we live!

1.3 PACKAGE

DIMENSIONS

AND WEIGHT

Total weight: 58 Kg

Store the package for possible future shipment.

1.4 UNPACKAGING

2. FAMILIARIZATION

2.1 OVERALL DIMENSIONS

2.2 USABLE SPACE IN THE CHAMBER

Diameter: 240 mm

Depth: 384 mm

Capacity: 17,5 l

Useful dimensions per tray: 315 x 214 mm (x 2),

315 x 168 mm (x 2)

Useful tray volume: 10 l

Net weight: 47 Kg

Full load weight: 58 Kg

2.3 SAFETY FEATURES

The sterilizer features several devices that assure the full safety for the operators.

Door with dual lock control

An electromechanical device allows the door to be opened only if the following conditions are met:

- unit power supplied and turned on

- no current alarms

- internal pressure not dangerous for the operator

For further safety, to unblock the door at the end of cycle or in case of alarm it is necessary to press the

Start/Stop button.

Attention: If the equipment is turned off with the door open, do not apply force on

the handle to try closing the door. To close it, the equipment must be on.

Protection against overpressure –safety and decompression valves

Safety valve - it takes over when the pressure inside the chamber exceeds the value of 2,55 bar. To

verify the efficiency of the valve, when the unit is cold and switched off, unscrew the black cap of the

valve, when a “click” is heard pull it gently : you have to feel that the cap is free to move. The valve can

not be adjusted or serviced for safety reasons. Follow the maintenance program described in the ap-

pendix SERVICE BOOK to assure the safety of the unit.

Decompression valve –it takes over when the pressure inside the chamber exceed the value of 2,4 bar;

an acoustic signal warns the operator and the display shows the message ALARM 10.

Overheating protection

The temperature inside the chamber is programmed so as not to exceed the limit of 142 °C; in case of fault,

a further protection takes over to prevent the temperature from rising over 150 °C.

Blackout protection

In case of power blackout during the sterilization cycle, the pressure inside the chamber is completely re-

leased to the drain valve. On power supply restore, the display will show the message BLACK OUT.

Automatic switch off

Elapsed 30 minutes from the end of the cycle without opening the door or activating a front panel button, the

unit will automatically switch off.

This function is not operating if no sterilization cycle has been carried out and completed.

2.4 PRECAUTIONS

The international norms concerning safety and sterilization process defines the following figures:

OPERATOR: the person operating the unit to achieve the expected result.

RESPONSIBLE AUTHORITY: person or group responsible for the use and maintenance of the unit, he

or she also has to make sure that:

- all personnel who operate or maintain the equipment are trained in its operation and in its safe use.

- there is regular training of all personnel concerned with the operation and maintenance of the

equipment, including emergency procedures for any toxic, flammable, explosive or pathogenic ma-

terial released into the environment.

- Records of attendance at training are maintained, and evidence of understanding demonstrated.

The purpose of this manual is to provide suitable use instructions for both figures: however it does not

give instructions concerning the STERILIZATION PROCEDURE and the cautions to be followed to pre-

vent contamination of instruments and/or personnel using the unit that is a assignment of the

RESPONSIBLE AUTHORITY of the practice.

We wish to point out the following risks:

The sterilization is a process that works by means of water steam under pressure and high temper-

atures; when the load is removed from the sterilization chamber always use tools and wear person-

al protections suitable for handling hot instruments.

On opening the sterilizer, especially in case the cycle has been aborted, a small quantity of hot wa-

ter steam or condensate can be released in the environment; be careful when opening the door.

If the condensation cycle is not brought to an end, the load, the trays and the tray support as well as

the chamber inner space are ALWAYS to be considered as potentially contaminating elements, as

long as a subsequent sterilization cycle has not been successfully completed.

The water (waste) contained in the recovery tank is to be regarded as biologically contaminating,

therefore when this tank is emptied, suitable precautions should be taken. The disposal of recovery

water needs to be done in accordance with the national or local regulation. Check the integrity of

the draining pipe before its use.

To prevent cross contaminations during the loading and unloading steps, open the door with clean

hands or wear uncontaminated gloves to avoid contaminating the door handle, do not use gloves

worn during the instruments decontamination step for this operation; when the sterilized instruments

are removed from the chamber, always use uncontaminated gloves.

In case of contact with hot water, steam or contaminated materials rinse with fresh water and seek

for medical help.

SYMBOLS

On the panels of the unit and in this manual, potential hazards and the parts that can be dangerous at high

temperatures, are marked with this symbol:

WARNING: instruments and chamber are very hot

Contamination risk

CAUTION, risk of danger

Documentation needs to be consulted

Read carefully this user manual because wrong use may expose the user to health risks.



This symbol indicates the presence of additional important notes about the use.

The water steam sterilizer is designed to be used for the sterilization of reusable medical instruments that can

be steam sterilized in a range of temperatures between 121°C and 135°C; any attempt of sterilizing instru-

ments that are not fit for undergoing this process can result in hazard for the operator: it can also lead to po-

tentially serious faults and damage the sterilizer’s safety mechanisms.

The unit is not to be used to sterilize liquids and flammable materials.

The unit is designed for indoor use only.

Do not use in presence of anesthetic or flammable gas.

To avoid an excessive level of humidity, properly air the room where the unit is installed.

2.5 FRONT AND REAR VIEW

Water outflow filter

Chamber water inlet

Door

Door handle

Control panel

Main (fresh) water tank feeding point

Bacterial filter

Door gasket

Quick connector for fresh water tank drain

Quick connector for waste water tank drain

Water inlet filter

Temperature sensor

Air line filter

Safety valve connection

Safety valve

Automatic draining of

used water tank (option):

max flow 20 ml/minute,

water T < 70°C

Heat exchanger

Power supply switch

Power supply

Printer interface

(option)

AC Fuses

Vent hole for waste

water tank

PC interface

USB port

ID plate

2.6 STANDARD ACCESSORIES

To make the warranty active it is necessary that a copy of the supplied Unit Passport is sent, through

the agent, to the manufacturer; for want of this the warranty will decline.

2.7 TECHNICAL SPECIFICATIONS

2.7.1 Environment operating conditions

The sterilizer is designed to operate in environments with temperature between 3 °C and 40 °C, relative hu-

midity <95%, atmospheric pressure from 750 mBar to 1050 mBar and altitude between 0 and +2000m.

Chamber dimensions

Ø = 240 mm

Depth = 384 mm

Auto-switching-off

elapsed 30’ from the end of a

cycle and without any action

Chamber capacity

17,5 l

Dual water tank

4 liters each (waste and

fresh water tanks)

Maximum load

4 kg (solid)

1,5 kg (porous)

Bacterial filter

0.3 µm al 99.97 %

Warming-up time

20’ from room temperature

10’ with pre-heated chamber

Clock battery

(may be replaced only by au-

thorized service)

Varta CR2032

Sterilization time

from 3’ to 90’ depending on the

selected cycle

Transmitted heat

in environment

0,22 J/h at 23°C

Drying time

from 6’ to 14’ depending on the

selected cycle

Sound emission

52 dB/A at 1 m

External dimensions

443 x 590 x 428 mm

(L x D x H)

Working cycle

continuous

Net weight

47 Kg

Pollution grade

Power supply voltage

230 Vac

Transient overvoltage

Frequency

50 / 60 Hz

Water conductivity

monitoring

yes

Max consumption

1920 W

Maximum volume available

on the trays

10 l

Average consumption

1000 W

Maximum chamber

temperature

135°C (-0/+2°C)

Standby consumption

10 W

Safety valve

working pressure

2,55 bar

AC Fuses

2 x 12,5A T (type 6.3 x 32 CT ) -

IEC 127

NEVER USE IN PRESENCE OF FLAMMABILE OR ANAESTHETIC GAS.

Tray rack (P/N 105078)

Operating Manual

Warranty paper

Cleaning tabs

Bacterial filter

(P/N 021008)

(+ 1 pcs extra)

Water filter

(P/N 105320)

(+ 2 pcs extra)

Filter spanner

(P/N 105228)

2+2 Trays

(P/N 105076 - 105077)

Tray holder

(PN/ 105619)

Drain tube

(P/N 119001)

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