iClave Operator Manual

Index

1. General Information... 5 1.1 1.2 1.3 1.4 1.5

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... 7

2. Safety information... 8 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

General safety information... 8 Safety and protection features on the device... 9 Soft-close door with double safety... 9 Overpressure protection - safety valve and pressure relief valve... 9 Blackout protection... 9 Overheating Protection... 9 Automatic power off... 9 Safety signs on the device...10 Residual risks... 11 Bacteriological risks... 11

3. Characteristics... 12 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.8.1 3.8.2 3.8.3

Description of the sterilizer... 12 Intended use... 12 Environmental conditions... 12 Units that make up the sterilizer... 13 Size and weight of package... 15 Size and weight of sterilizer... 15 Technical specifications... 16 Labels and symbols...18 Labels present on the back of the sterilizer...18 Labels and symbols present on the packaging...18 Symbols legend... 19

4. Installation... 22

4.1 Unpacking and transport...22 4.2 Positioning...23 4.3 Initial start-up...25 4.4 Home menù...26 4.5 Cicle menù...26 4.6 Test menù...26 4.7 Info menù...26 4.8 Settings menù...27 4.8.1 General settings...27 4.8.1.a Date and time modification...27 4.8.1.b Pressure and temperature unit modification...28 4.8.1.c Performance modification...28 4.8.1.d Language modification...28 4.8.2 Operator menù...29 4.8.2.a Create a new operator...29 4.8.2.b Modification of an existing operator...29 4.8.2.c Delete an existing operator...29 4.8.3 Printers menù...30 4.8.3.a Activation / Deactivation internal printer...30 4.8.3.b Activation / Deactivation label printer...30 4.8.3.c Activation / Deactivation report printer...30 4.8.3.d Re-print the label...30 4.8.4 Connections menù...30 4.8.5 Archiviation report menù...30 4.8.5.a Report export...31

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Index 4.8.5.b Format the USB stick...31 4.8.6 Maintenance menù...31 4.8.7 Technical menù...31

5. Using the sterilizer... 32

5.1 Turning the sterilizer on...32 5.2 Daily tests to check the sterilizer’s performance...32 5.2.1 Vacuum test ...32 5.2.2 Helix test and Bowie & Dick test...33 5.2.3 Dual test...33 5.3 Preparing the material before sterilization...33 5.3.1 Preliminary operations...33 5.3.2 Treatment of materials and instruments before sterilization...34 5.4 Arranging the material on the trays before sterilization...35 5.5 Opening / closing the door...36 5.6 Program selection...36 5.6.1 Sterlization time modification...38 5.6.2 Drying time modification...38 5.6.3 Cycle start delay...38 5.7 Running a cycle...38 5.7.1 Pre-heating phase (1)...40 5.7.2 Pulses phase (2)...40 5.7.3 Sterilization phase (3)... 41 5.7.4 Drying phase (4)... 41 5.7.5 End of cicle... 41 5.8 Interrupting the programme...42 5.9 Topping up with demineralized water and draining contaminated water...42 5.9.1 Topping up the demineralized water tank...42 5.9.2 Draining the used water recovery tank...42 5.9.3 Checking the water quality...43 5.10 Connections...44 5.10.1 Internal printer (optional)...44 5.10.2 External printer connection...44 5.10.3 Archiving on a USB stick (optional)...44 5.11 Cybersecurity...45 5.12 Firmware update...45

6. Alarms...46 6.1 6.2 6.3 6.4

Generality...46 Informations list...46 Notification list...47 Allarms list...47

7. Maintenance... 49 7.1 Ordinary maintenance...49 7.1.1 Demineralized water filter replacement and cleaning...49 7.1.2 Cambio e pulizia filtro H2O camera...50 7.1.3 Replacing the bacteriological filter...50 7.2 Scheduled maintenance...50 7.3 Periodic validation / requalification of the sterilization process...50 7.4 Fuses replacement... 51 7.5 Useful life of the device... 51 7.6 Spare parts... 51 7.7 Hot and cold spot inside the chamber...52 7.8 General Scheme...53 7.15.1 Idraulic circuit...53 7.15.2 Electric circuit...54

8. Disposal... 55 4

General Information

1. General Information 1.1

Purpose of the manual

This operator manual was issued by NSK Dental Italy 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 steam sterilizer, hereafter referred to in this manual as the “sterilizer” or, more simply, the “device”, and must always remain with it and be immediately available. 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 be 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 Dental Italy declines any responsibility 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 Dental Italy. NSK Dental Italy 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 coloured background, as illustrated below. Safety instructions are classified as follows, in accordance with the seriousness of the risk: Classification NOTE

Risk level 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.

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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. The operators who use the sterilizer daily are represented by qualified medical personnel: • • • • •

Doctor; Dental surgeon; Implantologist; Hygienist. Dental assistant

MAINTAINER: 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. TECHNICIAN: a person assigned to the extraordinary maintenance of the device. It is the person authorized to perform all electrical and mechanical interventions, adjustments and repairs. 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; the operator is adequately trained on hygiene and sterilization practices used in the dental field; • 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. Note: Any serious accident occurring with the device must be reported to the Manufacturer and to the competent authority of the Member State where the accident occurred. Please report incidents, near misses and product malfunctions to the NSK Dental Italy customer care office at: [email protected].

1.4 Conformity to European Directives As reported in the declaration of conformity Mod.444-003, drawn up in compliance with Article 19 Annex IV of the regulation 2017/745/EU, the iClave sterilizer manufactured by NSK Dental Italy meets the essential requirements defined by 2017/745/EU Regulation for medical devices, according to which it is classified in class IIa. It also complies with the Directives 2014/68/EC for pressure vessels (PED), 2014/30/EU (Directive Electromagnetic Compatibility) and 2014/35/EU (Directive Low Voltage). The iClave sterilizer also complies with the reference technical standards EN 13060, IEC 61010-1, IEC 61010-2-40 and IEC 61326-1. The declaration of conformity is a printed accompanying document in paper format. 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/RAEE). The equipment belongs to Category 8 (medical equipment).

CE Mark and Notified Body number. The CE mark indicates that the device satisfies the essential requirements of the Medical Devices Regulatory (UE) 2017/745. Notified Body: TÜV SÜD Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München – Germany., Identification N. 0123.

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General Information 1.5 Warranty NSK products are guaranteed against manufacturing errors and defective materials. NSK Dental Italy 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 Dental Italy 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 6.3 “Notice list” and paragraph 6.4 “Alarms list”. If the problem persists, do not attempt to operate the device but contact the NSK Dental Italy technical support: NSK Dental Italy, Via dell’Agricoltura 21, 36016 Thiene (VI), email address: [email protected] „ 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 Dental Italy. „ Faulty or damaged components should only be replaced with original NSK Dental Italy parts. The warranty is valid for 24 months from the date of sale of the device for any manufacturing errors or material defects. The effective date of the guarantee is determined by the date of the invoice for the purchase of the appliance. NSK Dental Italy reserves the right to analyze and establish the cause of any problem. The warranty does not cover: „ Damages related to normal wear, improper use, neglect, non-compliance with instructions for use „ Breakdowns due to natural disasters or fires; „ Damage due to improper interventions or repairs not authorized by NSK Dental Italy; „ Damage due to tampering by unqualified personnel; „ Anomalies deriving from parts or materials that are not original, therefore causes not attributable to the manufacturer. The warranty is also void if: „ The equipment shows damages caused by falling, by exposure to flames or in any case by causes not linked to manufacturing defects; „ There was an incorrect installation; „ There has been an incorrect connection to the electrical network (wrong nominal power supply voltage); „ The serial number has been removed, erased or altered.

Please note that opening the equipment by personnel NOT AUTHORIZED by the manufacturer entails the expiry of the warranty rights and the RESPONSIBILITY of the CE certification.

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Safety information

2. Safety information 2.1 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:

• Ensure that the device is connected to a power socket with a protective 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 Dental Italy power 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 Dental Italy 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 NSK Dental Italy original components and spare parts. • Use tape indicators to verify whether an item was successfully sterilised.

• • • • • • • • • • • • • • • •

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. It is the responsability of the user to fill the autoclave with clean demineralised water in compliance with the EN 13060 standard, free from contaminants and other pathogens.

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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 (Ambient pressure ±15mbar) For additional safety, the Unlock button on display must be pressed to unlock the door at the end of a cycle. 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.

2.2.2 Overpressure protection - safety valve and pressure sensor Safety valve This is a valve located on the back of the device that is triggered when the pressure inside the chamber exceeds 2.6 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 sensor This is triggered when the pressure inside the sterilization chamber exceeds 2.4 bar; an acoustic signal alerts the operator and the message A75 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 A70 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. This function is not implemented if no sterilization cycle has been run.

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Safety information

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! Drain water. Caution! Water loading area. Use only demineralized water. Tank capacity: 5 litres.

Caution! Hot surfaces.

Attention! Use the USB/Ethernet ports only for their intended purposes.

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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. 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. „ The use of contaminated water may involve residual risks. It is the responsibility of the user to fill the autoclave with clean demineralised water, free from contaminants and other pathogens. For the water quality see chapter 5.9.3 .

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Characteristics

3. Characteristics 3.1 Description of the sterilizer The iClave is a table-top steam sterilizer designed for the sterilization of dental and medical products and equipment, in accordance with the requirements of standard EN 13060. It consists of an airtight stainless steel 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 touchscreen controlpanel 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 Small steam sterilizer used to sterilize medical devices or for materials that are likely to come into contact with blood or body fluids, according to requirements of EN 13060:2014+A1:2018 it is suitable for following sterilization cycle types and loads: Class B sterilization Sterilization of solid products, porous products and lumen devices, wrapped or non-wrapped as represented by the test loads. Class S sterilization Sterilization of non-wrapped solid products. 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. The room where the device is installed should be adequately ventilated to prevent excessive humidity. Any possible condensation is collected in the small drip tray.

3.3 Environmental conditions The sterilizer is designed to operate in medical locations (e.g. Dental practices, dental and medical clinics, hospitals) with following environmental conditions: • temperatures between 5°C and 40°C; • maximum relative humidity of 80% with environmental temperature until 32°C and linearly decrease until 50% in case of environmental temperature until 40°C; • air pressure between 750 mBar and 1050 mBar; • altitude between 0 and +2000 meters above sea level. Transport and storage conditions: temperature -10°C÷50°C, humidity without condensation 10÷95%, air pressure 50÷106 kPa.

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Characteristics

3.4 Units that make up the sterilizer 2

1 3 4 5

7 6 9

11

10

12

8

13

14

18

15 17

16

13

Characteristics

19

20 21 22

26

28 Position

27

Description

1

Door

2

Clean demineralized water tank input

3

Operator panel

4

Front USB port

5

Main switch

6

Printer (optional)

7

Handle

8

Steel sterilizing chamber closure disc

9

Sterilization chamber

10

Safety valve connection

11

Pressure sensor

12

Temperature sensor

13

Tray Holder

14

Locking Electromagnet

15

Drain Filter

16

Clean water tank drainage connection

17

Used water tank drainage connection

18

Bacteriological filter

19

Condenser

20

Clean water load external connection

21

Used water drain external connection

22

Overflow drain connections

23

Sterilization chamber maximum pressure safety valve

24

Ethernet port (LAN)

25

Rear USB port (not usable for firmware update).

26

Power outlet

27

AUX port

28

Electrical protection fuses

14

25

24

23

Characteristics

3.5 Components supplied with the sterilizer 2

1

6

5

3

4

7

9

8

10

11

12

Position

Description

1

Rubber hose

2

Water filter extraction key

3

Small tray (2 pieces)

4

Large tray (3 pieces)

5

USB-key with operator manuals and general catalog (it can also be used for cycle downloads)

6

Tank water filter

7

Chamber water filter

8

Rear spacer (2 pieces)

9

Rack insertion and extraction clamp

10

Power Chord

11

Warranty certificate

12

Quick guide

15

Characteristics

3.6 Size and weight of package Packaging size: 570 x 672 x 780 (L x A x P) Total weight of iClave 18 package: 62 kg Total weight of iClave 24 package: 64 kg

570 780

Keep the original packaging intact.

672

3.7 Size and weight of sterilizer

451

iClave 18

iClave 24

Net unladen weight

52 kg

55 kg

Weight with full load

64 kg

67 kg

STERILIZER

492

STERILIZATION CHAMBER Diameter

265 mm

265 mm

Depth

382 mm

475 mm

Volume

18 litres

24 litres

622 669

975

511

16

Characteristics

3.8 Technical specifications iClave 18

iClave 24

Diameter

265mm

265mm

Depth

382mm

475mm

18 lt

24 lt

Solid load

5,0 kg

7,0 kg

Porous load

1,5 kg

2,0 kg

Chamber dimensions

Chamber volume Maximum load (including trays)

6’30” from room temperature 1’30” from preheated chamber

Heating time B Universal

4’

4’

B Prion

18’30”

18’30”

B Fast

3’30”

3’30”

B121

20’30”

20’30”

S Fast

3’30”

3’30”

B Universal

10’

10’

B Prion

14’

14’

B Fast

5’

5’

B121

16’

16’

S Fast

7’

7’

Sterilization time

Drying time

External dimensions

451 (W) x 492 (H) x 669 (L)

Net weight

59 kg

61 kg

Power voltage

230 V~ ±10 %

Frequency

50/60 Hz

Maximum power consumption

2350 W (10,7 A)

Average consumption

295 W (1,35 A)

Standby consumption

50 W (0,2 A)

Fuses

2 x T 16A, 400V (6,3x32mm)

Clock battery

Internal, not replaceable by the operator: CR2032

Double water tank

5 l (clean water tank) 5 l (used water tank)

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

600 cc ÷ 700 cc

800 cc ÷ 1050 cc

Vacuum pump

13 l/min - 0.96 bar

Bacteriological filter

0.3 µm al 99.97 %

IP rating (in accordance with EN 60529)

IP20 [1]

Separate heating system

Band heater with separate power distribution.

Heat transmitted to the environment at 23°C

2,16MJ

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Characteristics

Sound emission

60 dB(A)

Operating cycle

Continuous

Pollution level

2 (IEC 61010-1)

Transient overvoltage

II (IEC 61010-1)

Water conductivity control

LOW/HIGH WATER CONDUCIVITY (in reference to a value of 15 microsiemens)

Available volume on trays

10 l

Maximum chamber temperature

137°C (-0+2°C)

Safety valve intervention pressure [2]

2,6 bar

[1] Classification of the device with respect to the ingress of liquids (second digit of the IP20 degree, or 0), and protection from dangerous parts or against the access of solid foreign bodies (first digit of the IP20 degree, or 2). The first characteristic digit indicates that: 2 - Degree that the casing provides for the protection of people against access to dangerous parts (finger of test), preventing or limiting the penetration of a body part or a contested tool into the casing by a person (test gauge with a diameter of 12 mm) and at the same time the degree that the casing provides for the protection of the equipment against the penetration of solid foreign bodies (test sphere of diameter 12.5 mm); The second characteristic figure indicates the degree of protection of the casing against harmful effects on the equipment due to the penetration of liquids into the casing. 0 - no protection [2] Pressurized container conforming to Directive 2014/68/UE (PED)

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Characteristics

3.9 Labels and symbols 3.9.1

Labels present on the back of the sterilizer

There are 2 labels which are fixed in the back of the sterilizer: the serial number label and the UDI label. These labels contain, in addition to the CE marking, important data for operation, already indicated in the technical data table, and the serial number.

3.9.2

Labels and symbols present on the packaging

The sterilizer packaging contains printed symbols that represent the storage correct conditions, while during the autoclave packing a label is glued which contains all autoclave information..

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Characteristics 3.9.3

Symbols legend Symbol

Description Symbol for manufacturer.

1

2

MADE IN ITALY

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.

3

4 5

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

NSK Dental Italy S.r.l.

Manufacturer’s name.

Via dell’Agricoltura 21, 36016 Thiene (VI) IT Manufacturer’s address. Date of manufacture. The date given beside this symbol is the date of manufacture.

6

Serial number. 7 Device model. 8 Catalogue number 9 10

230 V~ 50/60 Hz 2350W

11

11A

Type of power supply, frequency and Maximum power. Maximum absorbed current. Type of fuses.

12 13

S.V.P.I. 2,6 bar

Safety valve intervention pressure.

14

Max W.P. 2,35 bar

Maximum work pressure.

15

Max W.T. 135°C

Maximum work temperature. Medical device.

16

17

The CE marking certifies that the product meets the standards applicable in the EU member states (see declaration of conformity).

20

Characteristics Identification number of the notified body. Notified body: TÜV SÜD Product Service GmbH, Zertifizierstelle, Ridlerstraße 65, 80339 München – Germany.

18

0123

19

EN13445 Ed.2019 Issue 4

20

Fluid Group 2

Fluid classification according with the PED directive.

21

Risk Category I

Sterilization chamber risk category.

22

Max. A.P. 2,6 barg

Maximum allowable pressure.

23

Volume 24L

Sterilization chamber nominal volume.

24

D.T. 140°C

Sterilization chamber project temperature.

25

D.P. 2,6 barg

Sterilization chamber project pressure.

26

Test Pressure 4,3 barg

27

Ts min +5°C / Ts max +140°C

Design code for the sterilization chamber.

Idrostatic test pressure. Chamber Maximum and minimum temperature. Caution, carefully read the instructions for use before using the device.

28

Attention residual risks.

Symbol for separate waste collection of electrical and electronic devices, in conformity with Directive 2012/19/EU (WEEE). 29

Symbol is used to indicate the need for the user to consult the instructions for use. 30

31

Symbol is used to indicate a vector that contains information about the unique identifier of the device.

32

UDI Barcode: The barcode follows the format HIBCC and is printed with AIDC technology or in the form human readable (HRI).

Temperature limit: Indicates the temperature limits to which the medical device can be safely exposed. 33

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