operation maintenance manual...operation & maintenance manual laboratory vertical steam...

OPERATION &

MAINTENANCE MANUAL

Laboratory Vertical Steam Sterilizers

(with cooling option)

models 2540, 3850, 3870 ELV

and 2540, 3850, 3870 ELVC

Cat. No. MAN205-0350-001E Rev A

Manufactured by: Tuttnauer Co. Ltd., Har Tuv Industrial zone B P.O.Box 170, Beit Shemesh 99000, Israel Tel: 972 2 9904611, Fax: 972 2 9904730 Tuttnauer U.S.A. Co., 25 Power Drive Hauppauge, NY,11788,USA, Tel:(800)6245836,(631)7374850, Fax:(631)737 07 20

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TABLE OF CONTENTS Paragraph Page No. 1. GENERAL ............................................................................................................4

1.1 Incoming Inspection....................................................................................4 1.2 Warranty ......................................................................................................4 1.3 Warranty Statement .....................................................................................4 1.4 Ordering Information ..................................................................................5

2. TECHNICAL DATA.............................................................................................6 2.1 Introduction .................................................................................................6 2.2 Operating Conditions...................................................................................7 2.3 Directives and Standards .............................................................................7 2.4 Environment Emission Information ...........................................................7 2.5 Specifications...............................................................................................8 2.6 Loading Capacities ......................................................................................9 2.7 Utility ...........................................................................................................9 2.8 Symbol Description....................................................................................10 2.9 Water Quality.............................................................................................13 2.10 Safety Features ..........................................................................................14

3. STERILIZATION PROGRAMS ........................................................................15 3.1 Program 1 – Unwrapped Instruments .......................................................16 3.2 Program 2 – Unwrapped delicate instruments ..........................................17 3.3 Program 3 – Liquid....................................................................................18 3.4 Program 4 – Liquid + Cool........................................................................19

4. KEYBOARD (keys and display)..........................................................................20 4.1 Description and Functions of the Front Panel Keyboard.........................21 4.2 Displayed Error and Operational Messages..............................................23

5. CHECKING AND CHANGING PARAMETERS AND OTHER DATA...........24 5.1 Menu ..........................................................................................................24 5.2 Setting the clock.........................................................................................25 5.3 Parameters .................................................................................................26 5.4 History........................................................................................................27

6. INSTALLATION ................................................................................................28 6.1 Environment Requirements.......................................................................28 6.2 Storage Requirements................................................................................28 6.3 Lifting and carrying...................................................................................28 6.4 Installation Site..........................................................................................28 6.5 Electrical Installation requirements..........................................................28 6.6 Other Installation requirements ................................................................28

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TABLE OF CONTENTS Paragraph Page No. 7. PRINTER............................................................................................................30

7.1 Printer Operation.......................................................................................30 7.2 Printer Output............................................................................................31 DPU 30 Printer Handling...................................................................................32

8. PREPARATION BEFORE STERILIZATION..................................................33 8.1 Instruments ................................................................................................33 8.2 Tubing........................................................................................................34 8.3 Liquids .......................................................................................................34 8.4 Loading ......................................................................................................34

9. OPERATION ......................................................................................................35 10. DOOR SAFETY SYSTEM..................................................................................38

10.1 Solenoid locking device .............................................................................38 10.2 Emergency door opening on models 2540, 3850, 3870, ............................38

11. SERVICE AND MAINTENANCE.....................................................................39 11.1 Preventive Maintenance ............................................................................39 11.2 Replacing the Air Filter.............................................................................40 11.3 Replacing the Door Gasket ........................................................................41 11.4 Checking the Safety Valve .........................................................................42 11.5 Cleaning water outlet strainer ...................................................................43

12. TROUBLESHOOTING ......................................................................................44 13. SPARE PARTS LIST..........................................................................................46 14. ACCESSORIES ..................................................................................................46

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TABLE OF CONTENT

Drawings Page No.

Overall Dimensions Drawing for the 2540 ELV .........................................................11 Overall Dimensions Drawing for the 3850 / 3870 ELV ..............................................11 Overall Dimensions Drawing for the 3850 / 3870 ELV ..............................................12 Baskets and Containers ...............................................................................................45

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1 GENERAL 1.1 Incoming Inspection The autoclave should be unpacked and inspected for mechanical damage

upon receipt. Observe packing method and retain packing materials until the unit has been inspected. Mechanical inspection involves checking for signs of physical damage such as: scratched panel surfaces, broken knobs, etc.

If damage is apparent, contact your dealer or point of purchase, so that they may notify the manufacturer and file a claim with the appropriate carrier.

All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination.

1.2 Warranty We certify that this instrument is guaranteed to be free from defects in

material and workmanship for one year against faulty components and assembly with the exception of glassware, lamps and heaters.

The warranty does not include and does not replace routine treatment and preventive maintenance to be performed according to instructions in paragraph 8.1 (Preventive Maintenance).

Our obligation is limited to replacing the instrument or parts, after our

examination, if within one year after the date of shipment they prove to be defective. This warranty does not apply to any instrument that has not been subjected to misuse, neglect, accident or improper installation or application, nor shall it extend to products that have been repaired or altered outside the factory without prior authorization from us.

The Autoclave should not be used in a manner not described in this manual!

1.3 Warranty Statement The warranty registration must be completed and returned to our service

departments; within fourteen (14) days of purchase or the warranty will be void.

Our Technical Service Depts can be reached at: Tuttnauer U.S.A., 33 Commac Loop, Equipark, Ronkonkoma, N.Y.

11779, U.S.A. +1-631-737 4850, Fax: +1-631-737 0720 Rudolf Gunz & Co. PTY LTD: Service Department, 26-34 Dunning Avenue, Ros, 2018, Sydney,

Australia. Service Department, Locked bag 690, Beaconsfield, NSW 2014,

Australia. +61-2-99356600 Fax: +61-2-99356650

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Note: If there is any difficulty with this instrument, and the solution is not

covered in this manual, contact our representative or us first. Do not attempt to service this instrument yourself. Describe the difficulty as clearly as possible so we may be able to diagnose the problem and provide a prompt solution.

If the autoclave is equipped with a printer, send along a copy of the last printout for our inspection. If replacement parts are needed, stipulate the model and serial number of the machine.

No products will be accepted for repair without proper authorization from us. All transportation charges must be paid both ways by the owner. This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer.

1.4 Ordering Information Several items must be specified when ordering the unit from the dealer.

• Exact model number (depending on desired chamber size). • Please specify the supply voltage available, 230/380V; 1PH or 3PH. • Temperature scale: Specify Centigrade or Fahrenheit. • Pressure scale: Specify kPa or psi.

1.4.1 Options • Printer option • Hanging temperature control probe for use with liquids, to be placed

directly inside a sample solution. • Cooling option - specify cooling method: with or without compressed

air. Air is used to balance the chamber pressure during the cooling stage.

1.4.2 Accessories Basket accessories: A set of two baskets is available for the unit.

The baskets are made of stainless steel wire and have a handle. The basket allows the operator to load a large quantity of materials into the chamber.

The pressure scale, printer option and cooling method can be set up at any time by a technician.

Stainless steel containers: A stainless steel container, for waste

products, is available. This container has vent holes on its upper part

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2 TECHNICAL DATA 2.1 Introduction Models 2540, 3850, 3870, ELV are vertical sterilizers designed especially

for sterilization of instruments, liquids and other materials in hospital laboratories, medical laboratories, research institutes, food laboratories and pharmaceutical facilities.

A special feature of this sterilizer is the fast cooling operation, provided as an option for the liquids sterilization cycle.

The sterilizer is fully automatic with a choice of four programs, eliminating any need for operator intervention during a cycle. A computerized control unit enables precise control and monitoring of physical parameters and clear documentation of the sterilization cycles.

Safety valve, mounted on top of autoclave beside the pressure sensor and the pressure gauge, is set to 40psi; and protect the system from excessive pressure.

The autoclave is equipped with a manometer (pressure gauge) designed for reference only. In case that there is any problem with electricity supply during a sterilization cycle the pressure gauge will be used to verify that there is pressure in the chamber.

According to the standard for laboratory autoclaves this autoclave is equipped with two temperature sensors which protect the opening of the door if the temperature is too high.

This manual is intended to give the user a general understanding of how the autoclave works and indicates best ways to operate and maintain it in order to obtain optimum results and a trouble free operation.

After reading this manual, operating the autoclave should be straight forward. However, since the autoclave is built using high technology sensitive components, no attempt should be made by the user or any other unauthorized person to repair or re-calibrate it.

Only technical personnel having proper qualifications, holding technical documentation and adequate test instrumentation, are authorized to undertake repair or service.

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2.2 Operating Conditions • The autoclave is for “Indoor use” only. • Only autoclavable materials shall be used. • The ambient temperature shall be in the range of 10°C and 40°C and a

relative humidity up to 85%. • The operation altitude of this autoclave is restricted to 2000m.The

ambient pressure shall not be lover than 80kPa (11.6psi) • The autoclave shall not be used in a manner not specified in this

manual! Caution Waste water should be brought into the public net in accordance with the local rules or requirements i.e. only non-hazardous liquids shall be disposed in public sewage!

2.3 Directives and Standards

Every autoclave meets the provisions of the following Directives and is constructed in compliance with the following Standards:

2.3.1 Technical Directives

1. Pressure Equipment Directive 97/23/EC. 2. Council Directive for voltage limits 73/23/EEC.

2.3.2 Technical Standards

1. The pressure vessel is an integral part of the equipment and complies with the ASME code, Section VIII div.1 for unfired pressure vessels

2. IEC-61010–2-041 & IEC-61010–1: Safety requirements for medical device.

3. UL – 1998 Software in Programmable Components

2.3.3 Quality standards The manufacturing plant meets the following quality standards:

1. EN ISO 9001 (7.94): Quality System 2. EN 46002 (8.96): Quality System - Medical device -

Particular requirements. 3. ISO 13488: Quality systems – Medical devices –

Particular requirements for the application of ISO 9001.

2.4 Environment Emission Information A. Peak sound level generated by the sterilizer is less than 70 / dBA with

a back sound level of 60 dBA. B. Total heat transmitted by the sterilizer is less than 300 W/h

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2.5 Specifications 2.5.1 Dimensions

MODEL DIMENSIONS

2540 3850 3870

Chamber diameter in mm. 250 380 380

Chamber depth in mm. 400 480 680

Chamber volume (L) 23 65 85 Height (mm) 665 760 960

Width (mm) 500 650 650 Overall dimensions

Length (mm) 335 500 500

2.5.2 Technical Data

MODEL PROPERTY

2540 3850 3870

Chamber material St. St. 316 Ti

(1.4571)

St. St. 316 Ti

(1.4571)

St. St. 316 Ti

(1.4571)

Door material ST.ST. 304L

ST.ST. 304L

ST.ST. 304L

Air supply pressure to be regulated Bar (psi) 3-8 (43-116) 3-8(43-116) 3-8(43-116) Feed water pressure To be regulated Bar (psi) 2-3 (29-43) 2-3 (29-43) 2-3 (29-43)

Net weight kg (lb) 48 (105) 85 (187) 100 (220) Shipping volume (m3) 0.21 0.56 0.56 Shipping weight kg (lb) 57 (125) 101 (222) 116 (255)

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2.6 Loading Capacities Maximum load is as follows: Model 2540 ― 10 liters Models 3850/70 ― 20 liters

2.6.1 Erlenmeyer Flasks

SIZE 2540 3850 3870

250 ml 2 x 5 3 x 12 4 x 12500 ml 2 x 4 2 x 7 3 x 7 1000 ml 1 2 x 4 2 x 4 2000 ml 1 3 2 x 3 3000 ml 1 2 2 x 2 5000 ml 1 1 1

2.6.2 Medium Flasks (Schott)

SIZE 2540 3850 3870

250 ml. 2 x 8 3 x 18 4 x 18500 ml 2 x 5 2 x 11 3 x 111000 ml 4 2 x 8 2 x 8 2000 ml 1 4 2 x 4 5000 ml 1 2 2 10000 ml 1 1

2.7 Utility

Utility Value

2540 2Ph, 208V/60Hz, 10A Electrical data

3850/70 3 Ph, 208V/60Hz, 3x16A Compressed Air 1/2" 3-4 Bar, 60l/min Tap water 1/2", 2-3 Bar Mineral free water 1/2", 2-4 Bar Drain Withstanding temp. of 230°F min.

Attention: The electrical net must be protected with a current leakage safety relay. The electrical network must comply with local rules or regulations.

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2.8 Symbol Description

Caution! Consult accompanying documents

Caution! Hot surface

Caution! Hot steam

Protective earth (Ground)

Stand by

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OVERALL DIMENSIONS DRAWING FOR THE 2540 ELV

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OVERALL DIMENSIONS DRAWING FOR THE 3850 / 3870 ELV

Note: The dimensions A, B and C are different for the models 3850 and 3870, as

indicated below

TYPE A B C

3850 1220 745 500

3870 1400 925 680

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2.9 Water Quality 2.9.1 Water for Steam Generation

The distilled or mineral – free water supplied to the autoclave should have the physical characteristics and maximum acceptable level of contaminants indicated in the table below:

Physical Characteristics and Maximum acceptable

contaminants levels in water for sterilizers (In compliance with ISO 11134 and ISO 13683).

Evaporate residue ≤ 15 mg/l

Silica ≤ 2 mg/l

Iron ≤ 0.2mg/l

Cadmium ≤ 0.005 mg/l

Lead ≤ 0.05 mg/l

Rest of heavy metals ≤ 0.1 mg/l

Chloride ≤ 3 mg/l

Phosphate ≤ 0.5 mg/l

Conductivity ≤ 50 µs/cm

pH 6.5 to 8

Appearance colourless, clean, without sediment

Hardness ≤ 0.1 mmol/l Compliance with the above data should be tested in accordance

with acknowledged analytical methods, by an authorized laboratory.

Attention: We recommend testing the water quality once a month. The use of water for autoclaves that does not comply with the table above may have severe impact on the working life of the sterilizer and can invalidate the manufacturer’s guarantee.

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2.10 Safety Features

This autoclave includes built-in safety features such as: • Error message display. • Electronic pressure and temperature measurement. • Safety relief valve to avoid build-up of excessive pressure. • Door switches enabling operation to be started only when the door is

closed. • Water level safety device. • Excess temperature protection. • Interlock for door opening:

1. The sterilized liquid temperature, (as measured by the two temperature sensors) below the boiling point. 2. The chamber pressure is the same that the ambient pressure. 3. There electrical power is switched ON.

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3 STERILIZATION PROGRAMS The autoclave offers 4 sterilization programs. For changing any parameter refer to the Technician Manual.

Sterilization Programs: Fahrenheit Celsius Program 1 Unwrapped instruments 274°F 134°C Program 2 Unwrapped delicate instruments 250°F 121°C Program 3 Liquid 250°F 121°C Program 4 Liquid + Cooling 250°F 121°C

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Time Ambient Pressure and Temperature

134°C

3.1 Program 1 – Unwrapped Instruments Program 1 is recommended for sterilizing unwrapped instruments and

materials which its manufacturer declares their compliance to be sterilized in the following conditions, for immediate use and preventing cross infection.

274°F 4’

25.7°F 10PSIG

READY Nu:0001

09:02:41

Nominal Parameters • Sterilization temperature: 274°F (134°C) • Sterilization time: 4 min.

Operations Sequence • Water Inlet phase: Water enters the chamber, to the required level. • Heating phase: Water warms up until steam reach the sterilization

temperature. • Sterilization phase: Temperature is maintained constant at the preset

value for the sterilization time. • Exhaust phase: condense is rapidly exhausted from the chamber, until

pressure equalizes atmospheric pressure.

= Pressure = Temperature

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3.2 Program 2 – Unwrapped delicate instruments Program 2 is recommended for sterilizing unwrapped instruments and

materials which its manufacturer declares their compliance to be sterilized in the following conditions, for immediate use and preventing cross infection.

250°F

20’ 240.1°F 10PSIG

READY Nu:0002

08:17:26

Nominal parameters

• Sterilization temperature: 250ºF (121ºC) • Sterilization time: 20 min. Operations Sequence • Water Inlet phase: Water enters the chamber, to the required level. • Heating phase: Water warms up until steam reach the sterilization





Ambient Pressure and Temperature Time

121°C

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3.3 Program 3 – Liquid Program 3 is intended to sterilize liquids. The sterilization temperature is

121ºC with no cooling. The cycle ends with slow exhaust to prevent burst of the bottles.

Average cycle time: 2h15min for two containers of 700mL each one.

250°F

20’ 64.7°F

50PSIG

READY Nu:0003

13:14:47

Nominal Parameters • Sterilization temperature: 250ºF (121ºC) • Sterilization time: 20 min. Operations Sequence • Water Inlet phase: Water enters the chamber, to the required level. • Heating phase: Water warms up until steam reach the sterilization





Time

Ambient Pressure and Temperature

121°C

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3.4 Program 4 – Liquid + Cooling Program 4 is intended to sterilize liquids. The sterilization temperature is

121ºC with cooling. The cycle ends with introduction of compressed air during the cooling stage to prevent burst of the bottles followed with fast exhaust.

• Average cycle time: 1h30min for two containers of 700mL each one. • Average cooling stage time: 30min

250°F

20’ 64.7°F

50PSIG

READY Nu:0004

14:29:15

Nominal Parameters • Sterilization temperature: 250ºF (121ºC). • Sterilization time: 20 min. Operations Sequence • Water Inlet phase: Water enters the chamber, to the required level. • Heating phase: Water warms up until steam reach the sterilization


value for the sterilization time. • Cooling phase: Compressed air is supplied into the chamber to

minimize the pressure difference between the bottle with the liquid and chamber in order to prevent burst of bottles during the cooling. Tap water is introduced into the cooling coil to perform forced cooling. The temperature decreases to 90°C and the pressure decreases until it is close to atmospheric pressure. The forced cooling shortens the cooling stage significantly.

• Fast exhaust phase: after reaching the end temperature (90°C), steam is exhausted from the chamber until the pressure equals the atmospheric pressure.


Time

Ambient Pressure and Temperature

121°C

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Screen

Keypad

Power Switch

4 KEYBOARD (keys and display)

250°F 20’

64.7°F 50PSIG

READY Nu:0004

14:29:15

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4.1 Description and Functions of the Front Panel Keyboard

The front panel is composed of 3 sections: 1. Display screen. 2. Keypad. 3. Printer.

4.1.1 Description of the main screen

The graphic is used to display the current status of the autoclave while using Operational Messages and Error Messages.

Cycle information: • Cycle symbol • Sterilization temperature • Sterilization time • Dry time

Process information: • Operational messages • Error messages • Current stage

Time: • Clock • Counter

Chamber information: • Temperature • Pressure

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4.1.2 Description of the keypad

The keypad enables operation of the autoclave. Consist of 3 keys as described below.

UP key

This key enables increasing the value displayed above the cursor, at the clock programming and for setting of certain parameters by the technician.

DOWN key

This key enables decreasing the value displayed above the cursor, at the clock programming and for setting of certain parameters by the technician.

START/STOP key

This key commands the following 3 functions: • Starting the process. • Stopping the process. • Canceling the ERROR message from the

command panel and opening the electric door locking. 4.1.3 Description of the printer

The printer is an optional device. It prints the detailed history of each cycle performed by the autoclave. The printing is made on thermal paper with 24 characters per line and contains the record information for subsequent consideration.

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4.2 Displayed Error and Operational Messages

Message Message Description Corrective Action

Pt1 out This message is displayed when the Chamber Temperature sensor Pt1 is disconnected or out of range.

Call the technician

Pt2 out This message is displayed when the Chamber Temperature sensor Pt2 (additional safety feature) is disconnected or out of range.

Call the technician

Low Temperature

This message is displayed when the sterilization temperature wasn’t reached.

• Check that the autoclave is not overloaded.

• Check leakage from the door.

If the problem persist, call the technician

High Temperature

This message is displayed in one of the following cases: • If Chamber Temperature is grate than Limit

Temperature for more than 10 seconds. • If temperature rises 3°C above sterilization

temperature during the sterilization stage for 10 seconds.

Call the technician

No Water During all the cycles when there is no water in the chamber.

N/A

High pressure This message is displayed if Chamber Pressure raises 20kPa above sterilization pressure for 5 seconds during the sterilization stage.

Call the technician

Low Pressure This message displayed if Chamber Pressure drops bellow the sterilization pressure for 5 seconds during the sterilization stage.

Call the technician

Manual Stop This message is displayed if the STOP key is pressed and the cycle is aborted.

Low Heat

This message displayed if the system can't reach the required temperature in the chamber after 20 minutes during the Heating stage.

Check that the autoclave is not overloaded. If the problem persist, call the technician

Press Sensor Cutout

This message displayed if pressure sensor 1 of the chamber is disconnected or out of range on Prevacuum, Heating and Vacuum Test stages.

Call the technician

No Res Src.

This message is displayed if there is no water supply.

Check the connections to the water supply.

Door is Open Close the door to operate the autoclave. You can run a new cycle only when the door is close and the icon disappears.

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5 CHECKING AND CHANGING PARAMETERS AND OTHER DATA In order to set the autoclave's clock and date, and/or change the sterilization time, and to print the 10 previous cycles, you can enter three sub-directories and obtain the required data.

5.1 Menu

To enter in the menu screen press together the UP and DOWN keys. The code is 0001.

To increase the first digit press the UP key and go to the option SET by pressing the START/STOP key that enable to move ahead. Once you reach SET press the UP key to go into the MENU of the autoclave.

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5.2 Setting the clock

This directory enables you to set the time and date. First enter in the MENU.

Then go to the option “set clock” with the UP and DOWN keys and select it by pressing the START/STOP key.

This SET CLOCK screen is displayed:

When entering the set clock display, the time and date are displayed. The curser is blinking on the digits for the hour.

The time is displayed in the upper row in the form “hh:mm:ss”. The hour range is 24 hour (i.e. from “0” to “24”)

The date is displayed in the lower row in the form “DD:MM:YYYY”. 1. To increase or decrease the time or the date use the UP and DOWN

keys. 2. To move the curser from one digit to another press the START/STOP

key. 3. After completing setting the time and the date go to “save” to confirm

the new time and date by pressing UP key and then, go to “exit” by pressing UP key.

dd mn year

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5.3 Parameters

This directory enables you to see the cycle’s parameters. Enter in the menu by pressing the UP and DOWN keys together. Go to the option “PARAMETERS” with the UP and DOWN keys and select it by pressing the START/STOP key.

This CYCLE PARAMETERS screen is displayed:

1.5 1.6 1.7 1.8 1.9

You can see the parameters of the current cycle 1. Ster Time: sterilization time 2. Dry Time: the time of drying stage (N/A for this model) You can increase the different parameters to reach the required value.

NOTE: You can only change the values in the range of the default value to 99.

1. Use the UP and DOWN keys to increase or decrease the current digit in the

adequate range of value. 2. To move the curser ahead from one digit to another press the START/STOP

key. 3. After completing setting the parameter confirm the new value by pressing

SET 4. Go to EXIT and press the START/STOP key to leave the screen.

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5.4 History

This directory enables you to print the 10 previous cycles. 1. Enter in the menu screen by pressing together UP and DOWN keys. 2. Go to the option “HISTORY” with the UP and DOWN keys and

select it by pressing the START/STOP key.

This HISTORY screen is displayed:

3. Choose the cycle that you want according to its number with the UP and DOWN key

4. Select it by pressing the START/STOP key. 5. The cycle is printed. 6. In order to leave this screen go to the option EXIT with the UP and

DOWN key and select it by pressing the START/STOP key.

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6 INSTALLATION Attention Installation of the autoclave should be performed by an authorized technician.

6.1 Environment Requirements The ambient temperature shall be in the range of 10°C-40ºC and a relative

humidity of 85% respectively. The autoclave is intended to work in ‘indoor’ conditions.

6.2 Storage Requirements The packed or unpacked device shall be stored in ‘indoor’ conditions.

6.3 Lifting and carrying Qualified persons shall do lifting and carrying! Do not drop this device!

6.4 Installation Site 1. Install the autoclave according to the following guidelines: 2. Place the autoclave on the floor. Verify that the surface is leveled. 3. All utility supplies must be prepared in accordance with requirements,

before autoclave installation e.g. mineral-free and tap water, compressed air, one or three-phase power network, connection to the drain of the building.

4. Do not use the autoclave in the presence of dangerous gases. 5. Leave the space free around the autoclave for maintenance and service

requirements.

6.5 Electrical Installation requirements The model 2540 ELV is provided with a 2 phase line cord. The model 3850/70 ELV is provided with a 3 phase line cord. Connect the autoclave to the electrical power as follows: Connect the 2540 ELV with the cord supplied, to a two phases, 208V,

10A, 50/60Hz outlet supply. Connect the 3850/ 3870 ELV with the cord supplied, to a three phase

power network, 3 x 208V, 16A, 50/60Hz. The power network must be protected by a current leakage relay.

6.6 Other Installation requirements For all the ELVC models, the following utilities have to be connected

(Refer to the ‘Rear View’ drawings). For the sterilization process:

• Mineral-free water is having conductibility lower than 15µs (microsiemens), through a 1/2” flexible hose (supplied).

To obtain water quality meeting requirements a deionization column or reverse osmosis apparatus can be installed. The water must be delivered at a pressure of 2-3bars.

• Feed water from the water network, pressure 2-3bars, connected through a 1/2” pipe (supplied).

Attention Water backflow regulation shall be followed in accordance with

the local requirements

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• Compressed air, from a mobile compressor or compressed air network at pressure 3-4 bars, will be set at 1.6-2bars at the autoclave inlet is to be connected by a flexible conduit of 3/16” (supplied).

The air must be of instrumental quality filtered at 5µ and free of humidity and oil drops.

• Drain connected by 1/2” pipe, located at the rear of the unit. The chamber exhaust and coolant water is evacuated to an open waste funnel. The drainage piping must be heat resistant, to 230ºF, non-continuous flow.

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7 PRINTER 7.1 Printer Operation

The autoclave is equipped with a character printer, which prints a detailed history of each cycle performed by the instrument (for the record or for subsequent consideration).

The printing is made on thermal paper with 24 characters per line and

contains the following information: • Date • Real Time • Software version • Parameter version • Load number • Selected program • Sterilization pressure • Sterilization temperature • Sterilization time • Summary of performed cycle

When the sterilization cycle begins the printer starts printing the above data.

After the preliminary printing, the autoclave starts performing the

sequence of operations of the cycle. The measured values of temperature and pressure are printed at fixed time intervals, according to the phase of the process, as shown in the table below.

The data is printed from the bottom up, beginning with the date and ending with “CYCLE ENDED!” for a complete cycle or “CYCLE FAIL!” for an aborted cycle.

For an example of a typical printout, see next page.

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7.2 Printer Output

PRINTER OUTPUT DESCRIPTION Operator: To be filled in manually by operator Time: 09:17:34 Time sterilization cycle endedDate: 03/10/2006 Date sterilization cycle ended.CYCLE ENDED! 089.5 088.7 110.0Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)D 01:09:06 Status of the autoclave during drying stage 089.8 088.9 112.1Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)E 01:09:06 Status of the autoclave during exhaust stage 123.3 123.6 211.6Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)C 00:35:08 Status of the autoclave during cooling stage 123.3 123.6 211.6Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)S 00:35:08 Status of the autoclave during sterilization stage * * *

Prints sterilization data every 30 seconds

121.4 121.5 205.8Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)S 00:1508 Status of the autoclave during sterilization stage 109.9 110.0 144.0Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)H 00:08:57 Status of the autoclave during heating stage 026.6 026.8 098.9Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)W 00:00:00 Status of the autoclave during water inlet stage Dry Time: 000.0min Drying time for selected program.Ster Time: 020.0min Sterilization time for selected program. Ster Temp: 121.0°C Sterilization temperature in chamber for selected programCycle: Delicate Cycle nameLoad number: 0011 Cycle counterParam. Ver: 0037 Version of parameters setting.Ver: Lab 1.39 Software version.Ser.Num: 94967295 Autoclave's serial number.Time: 08:08:28 Time sterilization cycle started.Date: 03/10/2006 Date sterilization cycle started.POWER ON The device is turned onTime: 16:16:16 Start timeDate: 13/02/2006 Start datePOWER OFF The device is turned off Legend W Water inlet C Cooling stageH Heating stage E Exhaust stageS Sterilization stage D Dry stage

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7.3 DPU 30 Printer Handling 7.3.1 Setting Paper

1. Press the paper cover open button, and open the paper cover. Handle the paper cutter carefully not to cut your hand.

2. Set a paper roll as shown in the figure. 3. Close the paper cover by pressing both ends of the cover with the

tip end of the paper emerging from the cutter.

7.3.2 Maintenance 1. Wipe off the soiling on the printer surface with a dry soft cloth with

a weak neutral detergent. After that, wipe the printer with a dry cloth.

2. Test points: in the test print mode, characters printable with the printer (ANK, KanJi) and bar code are output turning power ON with the FEED IN signal kept low triggers the test print.

3. Caution: Never disassemble the printer. Failure to follow this instruction may cause overheating or burning of the printer or the AC adapter. Or an electric shock, which may lead to fires or accidents.

4. Never use the printer in a place of extreme humidity or any place where it can possibly be splashed by any liquids. If any liquids get into the printer, it could lead to fire, electric shock, or other serious accidents.

5. Never touch the thermal head immediately after printing because it becomes very hot. Make sure that the thermal head is cool before setting papers or cleaning the thermal head.

6. Power OFF the printer in any of the following cases:

• The printer does not recover from an error. • Smoke, strange noise or smells erupt from the printer. • A piece of metal or any liquid touches the internal parts or slot of

the printer. 7. Notes on treatment of thermal papers:

• Store the papers in a dry, cool and dark place. • Do not rub the papers with hard substance. • Keep the papers away from organic solvent.

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8 PREPARATION BEFORE STERILIZATION The purpose of packaging and wrapping of items for sterilization is to provide an

effective barrier against sources of potential contamination in order to maintain sterility and to permit aseptic removal of the contents of the pack. Packaging and wrapping materials should permit the removal of air from the pack, penetration of the sterilizing water vapor into the pack and removal of the sterilizing vapor.

The basic principle determining the size, mass and contents of instrument and hollowware packs is that the contents are sterile and dry immediately on completion of the drying cycle and removal of the pack from the sterilizer chamber.

Instruments to be sterilized must be clean, free from any residual matter, such as debris, blood, pads or any other material. Such substances may cause damage to the contents being sterilized and to the sterilizer. 1. Immediately after use, clean instruments thoroughly to dispose of any residue. 2. Follow the instrument manufacturer instructions. 3. It is recommended to wash instruments with an ultrasonic cleaner, using

detergent and mineral-free water. 4. Launder textile wraps prior to reuse. 5. After cleaning, rinse instruments for 30 seconds. (Follow manufacturer’s

instructions on the use of products for cleaning and lubricating instruments after using the ultrasonic cleaner).

6. Materials, including materials used for inner wraps, shall be compatible with the item being packed and the sterilizing method selected.

7. Use single-use wraps once only and discard after use. 8. If the unit is equipped with a printer, verify if a new roll of paper is necessary.

8.1 Instruments 1. Before placing an instrument onto the sterilizer baskets, ensure that

instruments that are not constructed of the same metal (stainless steel, carbon steel, etc.) are separated and placed in a different place.

2. Place empty containers upside down to prevent accumulation of water. 3. In case carbon steel instruments are placed in stainless steel baskets, the

baskets should be lined with a towel or paper wrap before placing the instruments on the baskets. There should be no direct contact between the carbon steel and the stainless steel baskets.

4. All instruments must be sterilized in an open position. 5. Place a sterilization indicator strip in each basket. 6. Place instruments with ratchets opened and unlocked or clipped on the

first ratchet position. 7. Disassemble or sufficiently loosen multiple-part instruments prior to

packaging to permit the sterilizing agent to come into contact with all parts of the instrument.

8. Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that only minimal resistance to removal of air, the passage of steam and condensate will be met.

9. Once a week, use a biological spore test indicator in any load to make sure sterilization is performed.

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10. Make sure that all instruments remain apart during the sterilization cycle.

11. Load the basket loosely to capacity. Note:

A table “Suitability of steam sterilization processes for various goods and method of packing” is added to the accompanying documents.

8.2 Tubing Clean tubing and rinse with pyrogen - free water. Ensure both ends of the

tube are open, and free of any sharp bends, twists or kinks.

8.3 Liquids 1. Use only heat- proof glass containers, filled to 90% capacity. 2. Introduce the two temperature sensors located in the door into the

containers to control the program and to ensure a correct and safely operating cycle. Each sensor shall be placed in a separate container.

8.4 Loading The loading of goods and instruments is done by means of two stacked

baskets. The baskets are provided with handles for the convenience of the operator.

There are 2 types of baskets: 1. Baskets that are fully perforated. 2. Baskets that are not perforated except one row of holes adjacent to the

basket’s top. These baskets are intended for waste cycles, to avoid clogging of the vessel’s drainage pipe by overflowing liquids.

Right Wrong

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9 OPERATION

9.1 Turning on the autoclave To start the system, turn on the main power switch located at the bottom of the front right corner of the panel, to power the electric system of the autoclave.

The software name and the autoclave model are displayed and then this main screen is displayed:

9.2 Verification before operating the autoclave

• Verify that the mineral free water supply is connected to the mineral free water inlet. NOTE: the electrical conductivity of the water must not exceed 15 micro-siemens.

• Verify that the date and the time are correct (see: SETTING THE CLOCK)

9.3 Loading Correct loading of the autoclave is essential to successful sterilizing for

several reasons. Efficient air removal from the chamber and the load will permit effective steam penetration and saturation, and allow proper drainage of condensate. Additionally, correct loading will prevent damage to packs and their contents and maximize efficient use of the sterilizer.

For detailed loading instructions, see para. 6 (Preparation before sterilization)

9.4 Operations

• To close the door, lift the handle of the tightening bolt in vertical position, and then rotate it clockwise until the bolt is hand tight. The operational message “Door is open” disappears indicating the door closed. Once the sterilization cycle is in progress, a safety device locks the door and makes it impossible to open it until completion of the cycle or a manual stop.

NOTE: Due to the inherent elasticity of the door gasket, the operational message “Door is open” may disappear before a complete seal is made between the door and the chamber. In order to ensure the door is fully sealed, when the operational message “Door is open” symbol disappeared continue to tighten the door bolt. Do not over-tighten the bolt as this may result in damage to the gasket.

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Should the autoclave fail to reach sterilizing temperature/pressure, always check first that the door is fully sealed. If not, tighten the door bolt further, as described above, until a complete seal is made.

• Select the required program by means of the keys UP , DOWN

and START/STOP . UP key: next program DOWN key: previous program START/STOP key: start the required program

9.5 End of the cycle

• At the end of the cycle the message “CYCLE END!” is displayed on the screen and the buzzer sounds one beep continuously during 3 seconds.

• In case the cycle has failed, the message “CYCLE FAIL!” is displayed on the screen, the buzzer sounds intermittently 3 beeps and the diagnostic of the failure is displayed on the screen. (For corrective action see displayed error and operational messages.) Press the START/STOP key to erase the fail message.

9.6 Unloading

• On completion of the cycle, open the door to remove the sterilized material from the autoclave. Rotate the handle of the tightening bolt counter-clockwise to the end then lower the bolt at right angle, parallel to the front cover. Lift the door in vertical position.

Before opening the door, verify that there is no pressure in the chamber (chamber pressure gauge is located on the autoclave's side cover). Open the door slowly to allow steam to escape. Don’t put your head or another member above the chamber for fear on an injury from hot steam.

• Take out the load immediately from the sterilizer. Do not remove the

load from the basket until its temperature reduces to the room temperature. Let the load cool down in an area without air movement (air conditioning, etc.) and with minimum people passing by to avoid possibility of touching the hot load. Do not touch the hot load since hot load absorbs moister and, therefore, may absorb bacteria from your hand. Do not transfer hot load to metal shelves for cooling. Perform a visual inspection to ascertain that sterilizing indicators have made the required color change, and that the load is dry.

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• The load shall be rejected if: a. The package has been compressed. b. The package is torn. c. The load is suspected to be wet. d. The load fell on the floor. e. Condensed drops can be detected on the load.

To avoid injuries use heat resistant gloves while unloading the autoclave.

9.7 Stopping the process • It is possible to stop the program while the autoclave is in process.

Pressing the START/STOP key at any stage of process, stops the operation.

9.8 Safety • Protective equipment and clothes and other safety instructions should

be implemented in accordance with local and national regulations and/or rules!

• For proper sterilization - Do not overload the chamber. Only autoclavable products shall be used; please refer to the manufacturer instructions for sterilization of unknown materials or instruments.

9.9 Moving the Autoclave

1. Disconnect the power supply cord. 2. Disconnect the water and drain hoses. 3. Disconnect the compressed air hoses. 4. Drain the water from the chamber.

To avoid injuries, lifting and carrying of model 2540 should be done by two people. Moving models 3850, 3870, should be done by using a forklift.

Caution: Before moving the autoclave, verify that the electrical, air and water connections have been disconnected, and there is no pressure in the chamber. Do not drop this device!

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10 DOOR SAFETY SYSTEM The door opening is ensured by two means:

1. The closing device prevents an incidental opening of the door. 2. A pull-type solenoid that in inactivated position locks the door and must be

electrically powered to release the locking and enable the opening of the door.

10.1 Solenoid locking device The solenoid locks the door in the following situations:

1. When the control unit is not powered. 2. If power failed or has been turned off while the autoclave is in

operation, even if power has been restored. 3. If operation was stopped before completion of the cycle as a result of

a failure or a manual stop. 4. When the temperature inside the autoclave chamber is higher than the

“end of cycle” temperature, preset by the operator; the opening of the door is possible only when the temperature has dropped below preset value.

For cases described at points 2 and 3, press START/STOP key to cancel the door locking at the end of the operation.

10.2 Emergency door opening on models 2540, 3850, 3870,

In order to facilitate initial installation, the door locking position is taped in this retracted position at the factory. On completion of all installation activities this tape must be removed.

If for any reason the door locking mechanism is permanently locked, it is possible to open the door and provide access for eventual repairs to the locking mechanism. Do not use force to open the door. The swing bolt has a drilled opening located in the lock catch. By pushing the piston back with a 2mm pin, the swing bolt may be turned another 1/4 position until the position catches again. Repeat these steps until the bolt is swung, and the door opened. Do not use force to open the door.

If, despite operating according to the instructions above, the door does not open, call an authorized technician.

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11 SERVICE AND MAINTENANCE 11.1 Preventive Maintenance

The maintenance operations described in this chapter must be fulfilled periodically in order to keep the autoclave in good working condition and to reduce the breakdown time to a minimum.

The user’s maintenance personnel, according to the following instructions can easily execute these operations.

The owner of the autoclave is responsible to order an authorized technician to perform the periodical tests and preventive maintenance operations, as specified in the technician manual.

Use only mineral-free water as detailed in para. 2.10 (water quality). Warning Before carrying out any preventive maintenance operation, ensure that the electrical cord is disconnected and there is no pressure in the autoclave.

11.1.1 Daily Clean the door gasket with a soft cloth. The gasket should be clean

and smooth.

11.1.2 Weekly 1. Remove the baskets (if applicable). Clean the chamber and

baskets with a cleaning agent & water and with a cloth sponge. You may use diluted lemon acid (25-50 CC lemon acid in 1 liter of water) as cleaning agent. If detergent is used, rinse baskets immediately with water to avoid stains on the metal. Caution Do not use steel wool or steel brush as this can damage the chamber!

2. Put a few drops of oil on the two door pins and door tightening bolts.

3. Clean outer parts of the autoclave with a soft cloth. 4. Drain out the vessel and clean the electrode with a soft cloth.

11.1.3 Periodically 1. Every 6 months replace the air filter, (if installed) according to

para. 10.2. 2. Every 6 months clean the electronic box with compressed air,

from inside outward. 3. Check the door gasket every 12 months and replace it if

required (see para. 10.3). 4. Once a year check and tighten the piping joints to avoid leakage. 5. Once a year check and tighten all screw connections in the

control box, heaters, valves and instrumentation. 6. Once a month clean the strainer as per para. 10.5. Cleaning

frequency may be reduced according to experience.

11.1.4 Periodical Tests

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1. Once every month activate the safety valve (see para. 10.4).

11.2 Replacing the Air Filter In order to “break” the vacuum, at the end of the dry phase, filtered

atmospheric air enters the chamber via a solenoid valve. The filtration of the air is performed by the bacteriological filter that is placed at the inlet of the chamber, through a solenoid valve.

The filter is mounted at the right side of the autoclave. . To replace the filter proceed as follows:

1. Open the right service door of the autoclave. 2. Unscrew the fittings (upper and lower fitting) connecting the filter to

the piping. 3. Replace the filter with a new one and reconnect the fittings. 4. Close the service door.

Air filter

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11.3 Replacing the Door Gasket For models 2540, 3850, 3870

Pull off the gasket from the door groove and install the new gasket referring to the drawings as above points 1, 2 and 3.

Caution! This gasket is designed with a trapezoidal cross section. The gasket should be placed with the widest side towards the door.

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11.4 Checking the Safety Valve The safety valve is located on the rear side of the autoclave In order to prevent the safety valve from a blockage, operate it once a

month.

1. Operate the sterilization cycle according to the manual. 2. Allow a pressure of approximately 200 kPa (29 psi) to build up in the

chamber. 3. Turn the safety valve pressure-regulating nut clockwise for 2 seconds.

Be careful not to burn your hands.

NOTE To avoid injuries use heat resistant gloves.

4. Return the nut to its original position. 5. Press the STOP key to interrupt the operation, and exhaust steam from

chamber. 6. Wait until the pressure decreases to zero, only then can the door be

opened.

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11.5 Cleaning water outlet strainer

Caution! Before proceeding, Make sure that the electric cord is disconnected and there is no pressure in the autoclave.

1. Open the left service door. 2. Open the strainer cover. 3. Remove the strainer element. 4. Rinse the strainer with water, using a brush if necessary. 5. Reinstall the strainer element. 6. Close the strainer cover. 7. Close the left service door.

Attention: Ensure the gasket is not misplaced, as this will prevent using the autoclave.

Strainer

Cap Strainer element

Strainer housing

Silicon gasket

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12 TROUBLESHOOTING Only technical personnel having proper qualifications and holding technical

documentation (including a technician manual) and adequate information are authorized to service the apparatus.

Problem Solution 1. Display is not

activated 1.1. Check the power source and verify that it is according to

specifications. 1.2. Verify that the main switch is in the ‘On’ position. 1.3. Make sure the power cord is properly connected to the

machine and the mains. (see rear view drawing) 1.4. Check the reset button on the cut-out thermostat.

Reset if necessary. 1.5. Make sure the circuit breaker has not tripped. Lift circuit

breaker's lever if necessary. Reset if necessary. 1.6. Verify that there is electrical power in the main source.

2. The printer prints,but nothing is printed on the paper

2.1. Verify the ribbon is O.K. replace if required (see para. 6.6 Replacing Ribbon Cassette)

2.2. Verify that the printing paper is inserted correctly (see para. 6.7 Printing Paper)

3. The printer does not print

3.1. Make sure the paper is inserted in the printer (see para. 6.7 Printing Paper)

3.2. Switch off the machine and switch it back on while pressing the feed button on the printer. If the printer prints a test printout, the printer is O.K. and there is a problem with the electronics. Contact the dealer to solve the problem. If the printer does not print the test printout, there is a problem with the printer. Contact your dealer to solve the problem.

4. When the machine is switched on, the printer feeds paper all the time

4.1. Make sure the “feed button” on the printer is not stuck.

5. The machine is leaking at the door

5.1. Make sure the door is tightened enough. 5.2. Replace the door gasket (see para. 10.4 Replacing the

Door Gasket) 6. Water does not

exit chamber due to clogged outlet strainer.

6.1. Clean strainer according to instructions.

If the problem persists, contact your dealer or point of purchase for further assistance If the above recommendations did not correct the malfunction, or if any problems not discussed in this section were encountered, please contact your dealer or point of purchase for further assistance.

.

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BASKETS AND CONTAINERS

Type Stainless steel wire baskets Stainless steel container for waste products, with vent holes

Max. Dia. x Height (mm) Capacity Max. Dia. x Height (mm) Capacity

235 x 350 1 235 x 350 1 2540

235 x 190 2

365 x 340 1 365 x 340 1 3850

365 x 225 2

365 x 340 2 365 x 340 2 3870

365 x 225 3

High Basket Container for waste products Low Basket

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13 SPARE PARTS LIST

Cat.No. Description

2540 3850, 3870

Cord + plug + socket EUR 230V WIR040-0003 —

Cap for ¼” strainer FIL175-0027 FIL175-0027

Strainer element FIL175-0046 FIL175-0046

Teflon gasket 4 mm GAS082-0008 GAS082-0008

Door gasket GAS080-0003 GAS080-0004

14 ACCESSORIES

Cat. No. Description

2540 3850, 3870

Paper, Roll, Printer, DPU-30 THE002-0025 THE002-0025

High BSK254-0001 BSK387-0001 Stainless steel wire basket

Low BSK254-0002 BSK387-0002 Stainless steel container for waste products, with vents holes BSK254-0003 BSK387-0003

operation maintenance manual...operation & maintenance manual laboratory vertical steam...

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