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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
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
Overall dimensions Width (mm) 500 650 650
Length (mm) 335 500 500

2.5.2 Technical Data


MODEL
PROPERTY
2540 3850 3870
St. St. St. St. St. St.
Chamber material 316 Ti 316 Ti 316 Ti
(1.4571) (1.4571) (1.4571)
ST.ST. ST.ST. ST.ST.
Door material 304L 304L 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 2x5 3 x 12 4 x 12
500 ml 2x4 2x7 3x7
1000 ml 1 2x4 2x4
2000 ml 1 3 2x3
3000 ml 1 2 2x2
5000 ml 1 1 1

2.6.2 Medium Flasks (Schott)


SIZE 2540 3850 3870
250 ml. 2x8 3 x 18 4 x 18
500 ml 2x5 2 x 11 3 x 11
1000 ml 4 2x8 2x8
2000 ml 1 4 2x4
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
colourless, clean, without
Appearance
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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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 25.7°F
4’
10PSIG

READY 09:02:41
Nu:0001

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.

134°C

Ambient Pressure
and Temperature Time

= 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 240.1°F
20’
10PSIG

READY 08:17:26
Nu:0002

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
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.

121°C

Ambient Pressure
and Temperature Time

= Pressure
= Temperature

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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 64.7°F
20’
50PSIG

READY 13:14:47
Nu:0003

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
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.

121°C

Ambient Pressure
and Temperature
Time

= Pressure
= Temperature

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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 64.7°F
20’
50PSIG

READY 14:29:15
Nu:0004
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
temperature.
• Sterilization phase: Temperature is maintained constant at the preset
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.

121°C
Ambient Pressure
and Temperature
Time

= Pressure
= Temperature

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4 KEYBOARD (keys and display)

250°F 64.7°F
20’
50PSIG Screen

READY 14:29:15
Nu:0004

Keypad

Power Switch

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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

Chamber information:
• Temperature
• Pressure

Time:
• Clock
• Counter

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

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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


This message is displayed when the Chamber Call the technician
Pt1 out Temperature sensor Pt1 is disconnected or out
of range.
This message is displayed when the Chamber Call the technician
Pt2 out Temperature sensor Pt2 (additional safety
feature) is disconnected or out of range.
This message is displayed when the sterilization • Check that the autoclave
temperature wasn’t reached. is not overloaded.
Low • Check leakage from the
Temperature door.
If the problem persist, call
the technician
This message is displayed in one of the Call the technician
following cases:
• If Chamber Temperature is grate than Limit
High
Temperature for more than 10 seconds.
Temperature
• If temperature rises 3°C above sterilization
temperature during the sterilization stage for
10 seconds.
During all the cycles when there is no water in N/A
No Water
the chamber.
This message is displayed if Chamber Pressure Call the technician
High pressure raises 20kPa above sterilization pressure for 5
seconds during the sterilization stage.
This message displayed if Chamber Pressure Call the technician
Low Pressure drops bellow the sterilization pressure for 5
seconds during the sterilization stage.
This message is displayed if the STOP key is
Manual Stop
pressed and the cycle is aborted.
This message displayed if the system can't Check that the autoclave is
reach the required temperature in the chamber not overloaded.
Low Heat
after 20 minutes during the Heating stage. If the problem persist, call
the technician
This message displayed if pressure sensor 1 of Call the technician
Press Sensor the chamber is disconnected or out of range on
Cutout Prevacuum, Heating and Vacuum Test stages.

This message is displayed if there is no water Check the connections to the


supply. water supply.
No Res Src.

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:

dd mn year

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.

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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.

Page 29 of 46
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.

Page 30 of 46
7.2 Printer Output

PRINTER OUTPUT DESCRIPTION


Operator: To be filled in manually by operator

Time: 09:17:34 Time sterilization cycle ended


Date: 03/10/2006 Date sterilization cycle ended.
CYCLE ENDED!
089.5 088.7 110.0
Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)
D 01:09:06 Status of the autoclave during drying stage
089.8 088.9 112.1
Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)
E 01:09:06 Status of the autoclave during exhaust stage
123.3 123.6 211.6
Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)
C 00:35:08 Status of the autoclave during cooling stage
123.3 123.6 211.6
Temperature 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
*
121.4 121.5 205.8
Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)
S 00:1508 Status of the autoclave during sterilization stage
109.9 110.0 144.0
Temperature sensor 1 (°C) Temperature sensor 2 (°C) Chamber pressure (kPa)
H 00:08:57 Status of the autoclave during heating stage
026.6 026.8 098.9
Temperature 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 program
Cycle: Delicate Cycle name
Load number: 0011 Cycle counter
Param. 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 on
Time: 16:16:16 Start time
Date: 13/02/2006 Start date
POWER OFF The device is turned off
Legend
W Water inlet C Cooling stage
H Heating stage E Exhaust stage
S Sterilization stage D Dry stage

Page 31 of 46
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.

Page 32 of 46
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.

Page 33 of 46
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.

Wrong Right

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.

Page 34 of 46
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.

Page 35 of 46
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 .
ƒ UP key: next program
ƒ DOWN key: previous program
ƒ 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.

Page 36 of 46
• 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!

Page 37 of 46
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.

Page 38 of 46
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

Page 39 of 46
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

Page 40 of 46
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.

Page 41 of 46
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.

Page 42 of 46
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 Silicon Strainer Strainer


gasket element housing

Page 43 of 46
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 1.1. Check the power source and verify that it is according to
activated 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, 2.1. Verify the ribbon is O.K. replace if required (see para. 6.6
but nothing is Replacing Ribbon Cassette)
printed on the 2.2. Verify that the printing paper is inserted correctly (see
paper para. 6.7 Printing Paper)
3. The printer does 3.1. Make sure the paper is inserted in the printer (see para.
not print 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 4.1. Make sure the “feed button” on the printer is not stuck.
machine is
switched on, the
printer feeds
paper all the time
5. The machine is 5.1. Make sure the door is tightened enough.
leaking at the 5.2. Replace the door gasket (see para. 10.4 Replacing the
door Door Gasket)
6. Water does not 6.1. Clean strainer according to instructions.
exit chamber due
to clogged outlet
strainer.
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.
.

Page 44 of 46
BASKETS AND CONTAINERS

Container for waste products High Basket Low Basket

Stainless steel container for waste


Type Stainless steel wire baskets
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  

Page 45 of 46
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,
BSK254-0003 BSK387-0003
with vents holes

Page 46 of 46

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