iClave plus Steam sterilizer Operator Manual Rev 8 March 2021

TABLE OF CONTENTS

1

GENERAL INFORMATION... 5

2

SAFETY INFORMATION... 7

3

CHARACTERISTICS... 11

4

INSTALLATION... 20

5

USING THE STERILIZER... 25

1-1 1-2 1-3 1-4 1-5 2-1 2-2 2-2-1 2-2-2 2-2-3 2-2-4 2-2-5 2-3 2-4 2-5 3-1 3-2 3-3 3-4 3-5 3-6 3-7 3-8 3-9 4-1 4-2 4-3 4-4 4-5 4-6 5-1 5-1-1 5-1-2 5-1-3 5-2 5-3 5-3-1 5-3-2 5-4 5-4-1 5-4-2 5-5 5-6 5-7 5-8 5-9 5-9-1 5-9-2 5-9-3 5-9-4 5-9-5

Purpose of the manual... 5 Criteria for use of the manual and finding information... 5 Professional user profiles... 6 Conformity to European Directives... 6 Warranty... 6 General safety information... 7 Safety and protection features on the device... 8 Soft-close door with double safety... 8 Overpressure protection - safety valve and pressure relief valve... 8 Blackout protection... 8 Overheating protection... 8 Automatic power off... 8 Safety signs on the device... 9 Residual risks... 10 Bacteriological risks... 10 Description of the sterilizer... 11 Intended use... 11 Environmental conditions... 11 Units that make up the sterilizer... 12 Components supplied with the sterilizer... 14 Size and weight of package... 15 Size and weight of sterilizer... 15 Technical specifications... 16 Sterilizer regulatory label... 17 Unpacking and transportation... 20 Positioning... 21 Initial start-up... 23 Compensating for altitude... 24 Setting date and time... 24 Setting the language... 24 Description of the operator panel... 25 Display Colouring... 25 Display symbols... 25 Function buttons... 26 Turning the sterilizer on... 27 Daily tests to check the sterilizer’s performance... 27 Vacuum test ... 27 Helix test and Bowie & Dick test... 28 Preparing the material before sterilization... 28 Preliminary operations... 28 Treatment of materials and instruments before sterilization... 28 Arranging the material on the trays before sterilization... 29 Program selection... 30 Running the program... 31 Interrupting the programme... 33 Programming menu... 33 SET TIME... 33 SET SPECIAL CYCLE... 34 MEMORIES... 34 ENERGY... 35 ADJUST... 35 3

TABLE OF CONTENTS 5-10 Topping up with demineralized water and draining contaminated water... 36 5-10-1 Topping up the demineralized water tank... 36 5-10-2 Draining the contaminated water recovery tank... 36 5-11 Diagnostics... 37 5-11-1 Manual diagnostics... 37 5-11-2 Power-on automatic diagnostics... 37 5-11-3 Checking water quality... 38 5-12 Connections... 39 5-12-1 Connection to an external printer... 39 5-12-2 Connection to a USB log... 40

6

ALARMS... 41

7

MAINTENANCE... 43

6-1 6-2 6-3 7-1 7-2 7-3 7-4 7-5 7-6

4

Overview... 41 List of warning messages... 41 List of alarms... 42 Periodic maintenance... 43 Automatic sterilization chamber cleaning cycle... 43 Cleaning or replacement of the demineralized water filter... 44 Replacing the bacteriological filter... 45 Cleaning the instruments before sterilization... 45 Scheduled maintenance... 45

GENERAL INFORMATION - Chapter 1

1 1-1

GENERAL INFORMATION Purpose of the manual

This operator manual was issued by NSK to provide the operator with the necessary information for: „ proper installation „ appropriate and safe use „ careful maintenance The manual is an integral part of the iClave plus steam sterilizer, hereafter referred to in this manual as the “sterilizer" or, more simply, the "device", and must always remain with it, even when sold. It should always be kept close to the device, in an easily accessible place, and protected from environmental agents that could affect its integrity and durability. It should readily at hand for immediate consultation at any time by operators and maintainers. Read the manual carefully and understand it fully before installing the device and putting it into service, particularly the instructions given in the chapter on “Safety information”, which are aimed at preventing potential risks that could cause injuries to the operator or damage to the device. The company that uses the devices is responsible for always ensuring that all operators fully understand the operating instructions. NSK declines any liability for failure to observe the safety and prevention rules described in the various sections of this manual and for damages caused by improper installation and use of the device. All rights are reserved. This publication may not be reproduced, transmitted, transcribed, stored in computer systems or translated into another language or computer language, even partially, in any form or by any means without prior written permission from NSK. NSK reserves the right to make changes to the technical characteristics of the product described in this manual at any time, with no obligation of prior notice or communication.

1-2

Criteria for use of the manual and finding information

The information and instructions are collected and organized into chapters and paragraphs, and can be easily found by searching the index. Information preceded by a warning sign must be read carefully. Basic information for the health and safety of operators/maintenance personnel is contained in a box marked with warning signs on a grey background, as illustrated below. Safety instructions are classified as follows, in accordance with the seriousness of the risk: Classification

Risk level

NOTE

Information on general product specifications highlighted to prevent malfunctions and loss of product performance.

CAUTION

Indicates cases where failure to follow the safety instructions may lead to minor or considerable injury to people or damage to the device.

WARNING

Indicates cases where failure to follow the safety instructions may lead to serious injury to people or damage to the device.

5

Chapter 1 - GENERAL INFORMATION 1-3

Professional user profiles

European regulations on safety and the sterilization process describe the following professional roles: OPERATOR a person who uses the device for the intended purpose on a daily basis MAINTENANCE TECHNICIAN a person assigned to the ordinary maintenance of the device on a daily basis Note: the operator and maintenance technician may also be the same person. RESPONSIBLE AUTHORITY: an individual (often the employer) or group of people responsible for the use and maintenance of the device, who ensures that: • the operator and maintenance technician are adequately trained to use the device in full safety; • regular training is provided for all personnel regarding the operation and maintenance of the device, including emergency procedures in the event of emission of toxic, flammable, explosive or pathogenic material into the environment; • registration documents for attendance of the training are preserved and its full understanding is verified; • a written, electronic or paper record is kept of the sterilization procedures carried out from the moment the device is installed.

1-4

Conformity to European Directives

The IClave plus sterilizer produced by NSK Dental Italy satisfies the essential requirements of the Directive 93/42/EEC for medical devices, European Standard EN 13060 and Directive 2014/68/EC for pressure equipment (PED). This NSK product has been designed and manufactured with high quality materials and parts that can be recycled and reused. Separate disposal of electrical and electronic equipment, in accordance with Directive 2012/19/UE (WEEE). The equipment belongs to Category 8 (medical equipment). In force in the nations of the European Union, Norway and Switzerland.

CE Mark and Notified Body number. The CE mark indicates that the device satisfies the essential requirements of the Medical Devices Directive 93/42/EEC. Notified Body: IMQ S.p.A., Via Quintiliano, 443, 20138 Milan (Italy), Identification N. 0051.

1-5

Warranty

NSK products are guaranteed against manufacturing errors and defective materials. NSK reserves the right to examine and determine the cause of any problem. The warranty will be void if the product has not been used properly or for its intended use, if it has been tampered with by unqualified personnel or fitted with non-original NSK parts. Replacement parts are available for ten years after production of the model has ceased. Failure to follow the guidelines given below will void the warranty and/or make the device dangerous to operate. „ In the event of faults and/or malfunction, follow the guidelines given in paragraph 6.2 “Warning messages” and paragraph 6.3 “List of alarms”. If the problem persists, do not attempt to operate the device but contact the NSK technical support. „ Do not operate the device until the necessary repairs have been made to restore its proper operation. „ Do not attempt to disassemble the device, replace faulty or damaged components and/or have it adjusted or repaired by personnel without proper training and authorization from NSK. „ Faulty or damaged components should only be replaced with original NSK parts.

6

SAFETY INFORMATION - Chapter 2

2 2-1

SAFETY INFORMATION General safety information

To maintain a maximum level of device safety for patients and specialized professional operators, it is essential that: „ the operators and maintenance technicians have read and understood the instructions for installation and use of the device „ the periodic maintenance operations described in the chapter 7 “Maintenance” are carried out „ the following safety instructions are observed: WARNING • • • • • • • • • • • • • •

Ensure that the device is connected to a power socket with an earth connection. Keep the plug in the socket until the sterilization is finished and do not use the socket for other devices at the same time. Use only original NSK cables, as other cables can cause electric shock, fires or damage to the device. Do not turn the power on or off unless strictly necessary, as this may trip the fuse. Do not touch the power cord with wet hands as this may cause electric shock. Install the product with sufficient space to allow immediate removal of the electrical plug. Turn off the power switch and disconnect the power cord before performing any maintenance. Do not connect non-original NSK accessories or equipment to the device. Keep explosive substances and flammable materials far from the device. If the device overheats or emits a bad smell, turn off the power switch immediately, remove the plug from the electrical socket and contact technical support. Do not allow water or disinfectant liquid to enter the inside of the device as it may cause a short circuit and electrical shock. Avoid inadvertently touching the door or the area around the chamber while the device is in operation or immediately after stopping the product, as these reach high temperatures and can cause burns. Do not obstruct or cover the steam outlet on the product with other objects. In addition, avoid inadvertently placing your face or hands near the steam outlet, as this can cause burns. Only use original NSK components and spare parts. CAUTION

• • • • • • • • • • • • • • •

The device must only be installed in enclosed environments. Install the machine on a flat surface. Do not sterilize liquids or objects other than medical instruments reported in the intended use. Avoid any impact on the device. Do not drop the device. Wash and dry objects before sterilization. Chemical detergent residues in the chamber can cause corrosion or leave bad odours on sterilized objects. Insert the objects to be sterilized using the racks. Directly inserting objects into the chamber may cause sterilization problems, discolouration or even damage to the objects. Ensure that any water has been drained before moving the device. Use a container or case for sterilizing fine-pointed objects, as these may protrude from the bottom of the rack. Sterilize the instruments in accordance with the parameters recommended by the manufacturer or retailer. If any irregularities are noticed during use, stop the sterilization cycle and contact technical support. Conduct periodic diagnostic checks and routine maintenance operations. If the device has not been used for a long time, check that it is working properly before use. Portable and mobile RF communication devices can interfere with the device. The device must not be used near or above another device. If this is not possible, ensure that all devices work properly. The device may malfunction if used near electromagnetic interference. Do not install the device near other equipment that emits magnetic waves. Turn off the power if an ultrasonic oscillation or electrosurgery device is located near the site of use.

7

Chapter 2 - SAFETY INFORMATION 2-2

Safety and protection features on the device

The sterilizer has several devices, listed below, that ensure the total safety of operators. 2-2-1

Soft-close door with double safety

An electromechanical device allows the door to be opened only under the following conditions: • device plugged in and switched on • no alarms activated • internal pressure not hazardous to the operator For additional safety, the Start/Stop button must be pressed to unlock the door at the end of a cycle.

CAUTION

2-2-2

If the device is switched off with the door open, do not try to close the door by forcing the handle. To close the door, simply turn the device on again using the main switch.

Overpressure protection - safety valve and pressure relief valve

Safety valve This is a valve located on the back of the device that is triggered when the pressure inside the chamber exceeds 2.55 bar. To check that valve is working properly, switch the device off and allow it to cool down, then unscrew the black cap, pull it slightly until a "click" is heard and then check that it moves freely. The safety valve requires no adjustment or maintenance. Pressure relief valve This is triggered when the pressure inside the sterilization chamber exceeds 2.4 bar; an acoustic signal alerts the operator and the message ALARM 16 appears on the display.

2-2-3

Blackout protection

In the event of a power supply failure during the sterilization cycle, the pressure in the chamber is completely released and brought down to ambience level. When the power supply returns, the message BLACK OUT appears on the display. 2-2-4

Overheating protection

The temperature inside the sterilization chamber is programmed to not exceed a limit of 142 °C; in the event of failure, additional protection is provided to prevent the temperature from rising above 150 °C. 2-2-5

Automatic power off

Thirty minutes after the end of the cycle, unless the door has been opened or a button pressed on the front panel, the device automatically switches off. NOTE

8

This function is not implemented if no sterilization cycle has been run.

SAFETY INFORMATION - Chapter 2 2-3

Safety signs on the device

The following warning and hazard signs are located on the sterilizer in the positions indicated.

Caution! Hot surfaces.

Caution! Do not sterilize fluids.

Caution! Hot surfaces. Use only demineralized water. Tank capacity 4 litres.

Caution! Hot surfaces.

Caution! Service port for downloading data. Do not connect to the Internet. 9

Chapter 2 - SAFETY INFORMATION 2-4

Residual risks

The sterilization process works by means of pressurized steam at high temperature. When removing a load from the sterilization chamber, always use suitable tools and personal protective equipment for handling the hot racks and tools. When opening the sterilizer door, particularly during a cycle failure, a small quantity of steam or hot condensate may be released; open the door with caution.

WARNING

During normal daily use of the device, residual heat risks persist in the areas marked with special warning signs, as shown in the figure. Avoid direct contact of body parts with these surfaces.

Caution! Hot surfaces.

Caution! Hot surfaces.

2-5

Bacteriological risks

„ If the sterilization cycle is not completed, the load, the trays and their restraint system, as well as the inside of the chamber, should always be considered as potentially contaminated until a subsequent sterilization cycle has been successfully completed. „ The water in the recovery tank should be considered as contaminated, therefore necessary precaution should be taken when emptying the tank. Check the integrity of the drain hose before using it. „ To avoid cross-contamination, wear a new pair of sterile gloves for each task. Take particular care to replace the sterile gloves when loading or unloading instruments from the sterilization chamber and during maintenance operations.

10

CHARACTERISTICS - Chapter 3

3

CHARACTERISTICS

3-1

Description of the sterilizer

The IClave plus is a table-top steam sterilizer designed for the sterilization of dental and medical products and equipment, in accordance with the requirements of standard ISO EN 13060. It consists of an airtight copper sterilization chamber accessed through a front door; it is protected by an external shock-resistant moulded plastic body and equipped with protective devices that allow operators to use it in full safety. The sterilization cycles are started from the operator panel on the front of the device, beside the door. A detailed description of the units that make up the sterilizer and the components supplied is given in the following paragraphs.

3-2

Intended use

The steam sterilizer is intended for the sterilization of reusable medical devices suited to steam sterilization in a range of temperatures from 121 °C to 135 °C. The types of sterilization include: Class B sterilization Sterilization of all wrapped and unwrapped solid material, porous products as represented by the test loads and type A and B hollow loads. Class S sterilization Sterilization of products as specified by the manufacturer of the sterilizer, including unwrapped solid products and at least one of the following: • Porous products (fabrics) • Small porous items • Fluid loading or unloading products with type A and B hollows • Single-wrapped products • Products with multiple-layer wrapping

3-3

WARNING

Sterilizing instruments unsuitable for this process may expose the operator to risk, cause damage to the sterilizer and compromise its safety devices. Always check the manufacturer's label to ensure that products are suitable for sterilization. The device is not suitable for the sterilization of liquids and flammable materials. Do not use the device in the presence of anaesthetic or flammable gases.

NOTE

The room where the device is installed should be adequately ventilated to prevent excessive humidity.

Environmental conditions

The sterilizer is designed to operate in environments with: • temperatures between 10°C and 40°C. • relative humidity between 20% and 85%. • air pressure between 750 mBar and 1050 mBar • an altitude between 0 and 2000 above sea level. Storage conditions: temperature -10°C 50°C, humidity without condensation 10-95%, atmospheric pressure 5001060 mBar.

11

Chapter 3 - CHARACTERISTICS 3-4

Units that make up the sterilizer 2

1

3

4

7 6 14

5

13 23

8

12

9

10

11

CHARACTERISTICS - Chapter 3 15 16

17

19 20

22 12

Position

21

18

Description

1

Door

2

Clean demineralized water tank input

3

Handle

4

Operator panel

5

Steel sterilizing chamber closure disc

6

Bacteriological filter

7

Sterilization chamber

8

Clean demineralized water tank filter

9

Drain filter

10

Quick coupling for draining contaminated water tank

11

Quick coupling for draining demineralized water tank

12

Network port for technical support service data

13

Temperature sensor

14

Safety valve connection

15

Sterilization chamber maximum pressure safety valve

16

Automatic contaminated water recovery tank outlet for the Purity device (optional)

17

Condenser protection grid

18

Electrical supply input socket

19

Electrical protection fuses

20

Main switch

21

External printer port (optional)

22

Regulatory label

23

USB port 13

Chapter 3 - CHARACTERISTICS 3-5

Components supplied with the sterilizer 6

1

8

7

2 10

9

3

13

11

12

5

4

Position

Description

Code

1

Tray rack

105078

2

Small tray (2 pieces)

105076

3

Large tray (2 pieces)

105077

4

Power cord

5

Rack insertion and extraction clamp

105619

6

Rubber hose with quick coupling for draining water

119001

7

Water filter extraction key

105228

8

Water filter (2 pieces)

105320

9

Bacteriological filter

021008

10

Sterilization chamber cleaning tablets (2 pieces)

0230050

11

Operator manual

12

Warranty certificate

13

Quick guide

14

CHARACTERISTICS - Chapter 3 3-6

Size and weight of package

Packaging size: 720 x 600 x 530 (L x H x D) Total weight of package: 55 kg NOTE

3-7

Keep the original packaging intact

Size and weight of sterilizer STERILIZER Net unladen weight: Weight with full load:

45 kg 57 kg

STERILIZATION CHAMBER Diameter: 240 mm Depth: 384 mm Volume: 17.5 litres TRAYS Usable large tray space: Usable small tray space: Usable volume on trays:

315x214 mm (x 2) 315x168 mm (x 2) 10 litres

15

Chapter 3 - CHARACTERISTICS 3-8

Technical specifications

Chamber dimensions

Ø = 240 mm D = 384 mm

Chamber volume

17.5 l

Maximum load

4 kg (solid instruments) 1.5 kg (porous instruments)

Heating time

20’ from room temperature 10’ with preheated chamber

Sterilization time

From 3’ to 90’ depending on the cycle

Drying time

From 3’ to 14’ depending on the cycle

External dimensions

445 x 438 x 629 mm (L x H x D)

Net weight

45 kg

Mains voltage

230 VAC

Frequency

50/60 Hz

Maximum power consumption

1920 W

Average consumption

600 W

Standby consumption

12 W (20 W printer version)

Fuses

2 x FF 10A (type 6.3 x 32 H 500V)

Clock battery

Internal, not replaceable by the operator: CR2032

Automatic used-water drain rate (optional)

Max 0.5 l/min, T max 70 °C

Auto-off

after 30’ of inactivity at the end of the cycle

Double water tank

4 l each

“Average” water consumption for standard cycles 134°C - 121°C - 3 vacuum

584 cc - 627 cc

Vacuum pump

20 l/min - 0.96 bar

Bacteriological filter

0.3 µm at 99.97 %

IP rating (in accordance with EN 60529)

IP31

Noise level

53 db

Differentiated heating system

DHS

Heat transmitted to the environment at 23° C

2.16MJ

Operating cycle

continuous

Pollution level

2

Transient overvoltage

II

Water conductivity control

H2O GOOD / H2O HARD (in reference to a value of 15 microsiemens)

Available volume on trays

10 l

Maximum chamber temperature

135°C (-0+2°C)

Safety valve intervention pressure

2.55 bar

Pressurized container conforming to Directive 2014/68/UE (PED)

16

CHARACTERISTICS - Chapter 3 3-9

Sterilizer regulatory label

The regulatory label is fixed on the back of the sterilizer and displays the CE marking together with important data for operation, already given in the technical specifications table, and the serial number. For convenience, the device serial number is also displayed on an adhesive label on the lower section of the internal front panel, visible when the sterilization chamber door is open.

SERIAL NUMBER LABEL

17

Chapter 3 - CHARACTERISTICS Symbol

Description Symbol for manufacturer. The data given next to this symbol identifies the manufacturer. NOTE: this symbol must be accompanied by the name and address of the manufacturer.

1

2

NSK Dental Italy S.r.l.

Manufacturer's name

3

Via dell’Agricoltura 21, 36016 Thiene (VI) IT

Manufacturer’s address Manufactured for: Logo of the company for which the device is manufactured

4

CE marking in accordance with Dir. 93/42/EEC Medical Devices. The CE marking certifies that the product meets the standards applicable in the EU member states (see declaration of conformity)

5

6

0051

7

Small steam sterilizer

8

MOD.

Identification number of the notified body Notified body IMQ: IMQ S.p.A., Via Quintiliano, 443, 20138 Milan (Italy), Identification number: 0051. Explanation of use and application of the device Name of the device Reference to catalogue Symbol on the equipment: symbol located next to the model number (ref.to catalogue). NOTE The manufactorer‘s catalogue number shall be after or below the symbol adjacent to it.

9

Serial number 10 11

Voltage

Type of power supply

12

Power

Maximum power

13

Frequency

Frequency

14

Fuse

Type of fuses

14

Chamber capacity

Chamber capacity

15

Working pressure

Working pressure

16

Safety valve pressure

Safety valve discharge pressure

17

Working temperature

Working temperature Date of manufacture. The date given beside this symbol is the date of manufacture.

18

19

18

MADE IN ITALY

This is a merchandise mark indicating that a product is designed, produced and packaged entirely in Italy.

CHARACTERISTICS - Chapter 3 Caution, carefully read the instructions for use before using the device. 21

Symbol for separate waste collection of electrical and electronic devices, in conformity with Directive 2012/19/ EU (WEEE/RAEE). 22

19

Chapter 4 - INSTALLATION

4 4-1

INSTALLATION Unpacking and transportation

The packaging of the sterilizer consists of a wooden pallet on which the sterilizer is placed, with adequate protective padding and a corrugated cardboard casing fixed to the pallet with metal staples. Place the package on a level surface free from clutter to facilitate easy opening and safe extraction of the sterilizer. „ Remove the staples holding the casing to the pallet.

„ Remove the cardboard casing.

„ Remove the corner and edge protection from the sterilizer. „ Lift the sterilizer and position it in the place of installation.

CAUTION

20

Lifting, transporting and positioning the sterilizer in the place of installation should be performed by two people.

INSTALLATION - Chapter 4 4-2

Positioning

Check that the power supply voltage to the device matches that shown on the regulatory label on the rear panel, that the power outlet is designed to supply at least 16A and that it has an earth connection. If the installation makes the main power switch inaccessible, a specially dedicated accessible electrical disconnection switch should be provided.

WARNING

The manufacturer is not liable for damage to property or persons caused by electrical systems that are unsuitable or have no earth connections.

The device must be installed on a flat surface. If the support surface is perfectly horizontal, the front feet are already adjusted with a slight inclination to facilitate the flow of water during draining. If the support surface is not perfectly level, adjust the front legs, raising or lowering them to obtain a slight inclination, as shown in the figure.

WARNING

Do not place the device on a fragile surface that could be damaged or cause fire or smoke if hot objects fall.

For proper operation, leave a free space of at least 4 cm between the rear of the device and any wall. Do not install the device near heat sources or in damp or poorly ventilated spaces. The room must provide air circulation with at least 10 air changes per hour; a recirculating air ventilation system (e.g., an electric fan) cannot be used as an alternative.

CAUTION

The safety valve is on the rear of the device. When triggered by excess pressure, it releases very hot steam into the environment. Position the device to avoid risk of burns to the operator.

21