Tuttnauer 2340EA-D User manual

Operation and
Maintenance
Manual
Electronic Table-Top Autoclaves
Models 2340, 2840 EA-D, EKA-D, 3850,
3870 EA-D
Cat. No. MAN205-0494002EN Rev I
Tuttnauer Europe B.V.,
Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda, The Netherlands
Tel: [phone], Fax: [phone]

http://www.tuttnauerusa.com/

Page 1
TABLE OF CONTENTS
1. GENERAL ............................................................................................................................... 3
1.1. INCOMING INSPECTION ................................................................................................................ 3
1.2. WARRANTY DESCRIPTION............................................................................................................. 3
1.3. WARRANTY STATEMENT .............................................................................................................. 4
2. SAFETY INSTRUCTIONS .................................................................................................... 4
2.1. SAFETY FEATURES ....................................................................................................................... 4
2.2. SAFETY INSTRUCTIONS ................................................................................................................. 5
2.3. OPERATING CONDITIONS ............................................................................................................. 5
3. GENERAL INFORMATION.................................................................................................. 6
3.1. INTRODUCTION .......................................................................................................................... 6
3.2. SPECIFICATIONS.......................................................................................................................... 6
3.3. ELECTRICAL DATA ....................................................................................................................... 8
3.4. UTILITIES .................................................................................................................................. 8
3.5. ENVIRONMENTAL EMISSION INFORMATION ..................................................................................... 8
3.6. CONSTRUCTION.......................................................................................................................... 8
3.7. STICKERS DESCRIPTION ................................................................................................................ 9
3.8. WATER QUALITY ........................................................................................................................ 9
3.9. DIRECTIVES AND STANDARDS ...................................................................................................... 10
3.10. OVERALL DIMENSIONS –2340EA-D, EKA-D ................................................................................ 10
3.11. OVERALL DIMENSIONS –2840EA-D, EKA-D ................................................................................ 11
3.12. OVERALL DIMENSIONS – 3850EA–D .......................................................................................... 11
3.13. OVERALL DIMENSIONS – 3870EA–D .......................................................................................... 12
3.14. FRONT VIEW 2340EA-D, EKA-D, 2840EA-D, EKA-D............................................................... 13
3.15. FRONT VIEW 3850EA-D, 3870EA-D ...................................................................................... 14
3.16. REAR VIEW 2340EA-D, EKA-D, 2840EA-D, EKA-D ................................................................. 15
3.17. REAR VIEW 3850EA-D, 3870EA-D......................................................................................... 15
4. CONTROL PANEL ............................................................................................................... 16
4.1. DESCRIPTION AND FUNCTIONS OF THE CONTROL PANEL.................................................................... 17
4.2. DISPLAYED ERROR MESSAGES / SYMBOLS ..................................................................................... 20
4.3. DISPLAYED OPERATIONAL MESSAGES/ SYMBOLS ............................................................................ 20
5. STERILIZATION PROGRAMS.......................................................................................... 22
5.1. PROGRAM PARAMETERS ............................................................................................................ 22
5.2. CYCLE PROCESS DESCRIPTION...................................................................................................... 22
6. INSTALLATION INSTRUCTION...................................................................................... 23
6.1. PLACING ................................................................................................................................. 23
6.2. SETUP .................................................................................................................................... 23
6.3. LIFTING AND CARRYING ............................................................................................................. 23
6.4. FILLING THE MINERAL-FREE WATER RESERVOIR............................................................................. 24
7. PREPARATION BEFORE STERILIZATION. LOADING ............................................... 25
7.1. GENERAL RULES TO BE CONSIDERED:............................................................................................. 25
7.2. PACKS .................................................................................................................................... 27
7.3. WRAPPED INSTRUMENTS ........................................................................................................... 28
8. OPERATING INSTRUCTIONS ......................................................................................... 28
8.1. TURNING ON THE AUTOCLAVE..................................................................................................... 28
8.2. OPENING THE DOOR (3850EA-D, 3870EA-D)............................................................................. 28
8.3. OPENING THE DOOR (2340EA-D/EKA-D, 2840EA-D/EKA-D,)..................................................... 28
8.4. LOADING ................................................................................................................................ 29
8.5. CLOSING THE DOOR (3850EA-D, 3870EA-D) .............................................................................. 29
8.6. CLOSING THE DOOR (2340 EA-D/EKA-D, 2840EA-D, EKA-D) ...................................................... 29
8.7. STARTING THE CYCLE ................................................................................................................. 30
8.8. UNLOADING ............................................................................................................................ 30

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8.9. STOPPING THE PROCESS MANUALLY............................................................................................. 31
8.10. STOPPING THE PROCESS DUE TO CYCLE FAILURE.............................................................................. 31
9. CHECKING AND CHANGING PARAMETERS AND OTHER DATA............................. 31
9.1. QUICK OPTIONS SCREEN ............................................................................................................ 31
9.2. ENTERING THE MAIN MENU....................................................................................................... 32
9.3. SYSTEM PARAMETERS................................................................................................................ 32
9.4. MAINTENANCE ........................................................................................................................ 33
10. MAINTENANCE INSTRUCTIONS ............................................................................... 33
10.1. PREVENTIVE AND SCHEDULED MAINTENANCE ................................................................................ 33
10.2. DRAINING THE RESERVOIR.......................................................................................................... 34
10.3. CLEANING THE WATER OUTLET STRAINER ..................................................................................... 35
10.4. WATER SENSOR CLEANING......................................................................................................... 35
11. TROUBLESHOOTING .................................................................................................... 36
12. SPARE PARTS LIST ....................................................................................................... 38
13. ACCESSORIES ................................................................................................................ 38

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1. GENERAL
Read the Operating Instructions carefully, before beginning any
operation on the autoclave!
1.1. Incoming Inspection
Upon receiving your Tuttnauer Autoclave, carefully inspect the outside of the
shipping carton for signs of damage. If any damage to the carton is found,
note the location with respect to the autoclave and check that area of the
autoclave carefully once it is fully unpacked. 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 any damage is found, contact your dealer as soon as possible so that
they can file a claim with the shipping carrier and also notify Tuttnauer.
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.
Caution!
Lifting and carrying should always be done by two people.
1.2. Warranty Description
This warranty does not include routine cleaning and preventive
maintenance, to be performed according to instructions in section 10.1.
Tuttnauer warrantees all new EA-D, EKA-D autoclaves to be free from defects
in material and workmanship for a period of one full year, covering the parts
(except door gaskets and HEPA filters – they are considered wear items).
Tuttnauer warrantees all chambers for a period of ten (10) years against
defects in materials and workmanship. This chamber warranty went into effect
in January 1997.
This warranty does not apply to any instrument that has been subjected to
misuse, neglect, accident or improper installation or application, nor shall it
extend to autoclaves that have been repaired or altered outside the factory
without prior authorization from Tuttnauer.
Tuttnauer’s obligation is limited to the repair or replacement of parts for the
autoclave. This warranty will be void if the unit is not purchased from an
authorized Tuttnauer dealer. No other warranties or obligations are expressed
or implied.
The Autoclave should only be used in a manner described in this
manual!

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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 European Representative’s Technical Service Department can be
reached at:
Tuttnauer Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD
Breda, The Netherlands
Tel: [phone], Fax: [phone]
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 the serial number of the machine.
No autoclaves 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.
2. SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand the
operation instructions before first operation of the autoclave. This manual
includes instructions of operation, the door safety mechanism, dangers
involved in circumventing safety means, how to ensure that the door is closed,
and how to select a correct sterilization program.
Never use the autoclave to sterilize corrosive products (acids, bases, or
phenols) volatile compounds or solutions (ethanol, methanol or chloroform), or
radioactive substances.
2.1. Safety features
The autoclave has the following features for hazard protection:
1. Cut-off pressure switch
2. Cut-off thermostat
3. Electrical door lock
The main power is shut off if there is leak of water or the pressure is above
the safe level.
The pressure vessel chamber door has the following features protecting
personnel from hazards:
1. Two door switches that indicate that the door is closed and locked. Without
this indication steam is not introduced to the chamber.
2. A control that blocks door opening if the pressure is higher than 20% above
the ambient pressure.
Below are the safety instructions:

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2.2. Safety Instructions
All new autoclave users must undergo a period of training in proper
usage under an experienced employee.
When sterilizing plastic materials, make sure that the item can
withstand sterilization temperature. Plastic that melts in the chamber
is liable to cause a great deal of damage.
On closing the device door, make sure it is properly locked before
activating. Verify that DOOR OPEN symbol is replaced by the
“System ready” message.
When withdrawing trays, use the enclosed tray handle or wear heat
resistant gloves.
Before opening the door, verify that the pressure in the chamber
equals the atmospheric pressure (chamber pressure is displayed on
the screen).
Open the door slowly to allow steam to escape and wait 1 minute
before you remove the load.
Once a year certified inspector must perform pressure chamber
safety test.
Once annually, or more frequently, effective tests must be
performed, i.e., calibration and validation.
Make sure there are no leaks, breaks, blockages, whistles or strange
noises.
Perform maintenance operations as instructed. The owner of the
autoclave is responsible to perform the maintenance operations.
Notify the person in charge immediately of any deviation from the
proper function of the device.
Protective equipment and clothes and other safety instructions
should be implemented in accordance with local and national
regulations and/or rules!
2.3. Operating Conditions
This device is for indoor use only!
The sterilizer should be loaded only with autoclavable material!
Minimum room ventilation shall be 10 cycles per hour.
The environment shall not exceed an ambient temperature range of
from 5ºC (41ºF) to 40ºC (104ºF) and a relative humidity of 85%
respectively.
The operational altitude shall not be over 2000 meters (ambient
pressure shall not be lower than 80 kPa).
Operate the autoclave only in the manner specified in the manual. If the
equipment is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.
Caution!
Waste water should be brought into the public net in
accordance with the local rules or requirements
ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN
PUBLIC SEWAGE!

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3. GENERAL INFORMATION
3.1. Introduction
The EA-D, EKA-D tabletop autoclave is designed for sterilization of wrapped
and unwrapped instruments, and related items found in dental, medical, and
veterinary clinics, first aid rooms, hospitals laboratories etc.
This autoclave is an electrically – heated sterilizer using steam as the
sterilizing agent. A computerized control unit ensures a fully automatic
sterilization cycle, control and monitoring of physical parameters and a clear
documentation of the sterilization cycle.
The autoclave offers a choice of four automatic programs designed to match
the material to be sterilized. The autoclave is equipped with an air pump that
during the drying stage draws air through a HEPA filter (0.2µm) and pushes
that air through the heated chamber to remove moisture and facilitate the
drying operation. Drying is performed with the door closed.
On all models, a water pump is installed between the water reservoir and the
chamber. This pump guarantees fast and accurate filling of the chamber every
time. Entry of water may be accompanied by a noise for approximately 30
seconds. This is normal noise generated by the regular operation of the pump.
The EA-D, EKA-D series features a digital display for monitoring and control
purposes. The device is capable of displaying the pressure in psia, psig, or in
kPa according to the operator’s requirements. When the pressure is displayed
in psig, the atmospheric pressure is shown (at sea level) as 0 psig. If the
pressure is defined in psia or kPa the absolute zero is displayed as “0” and the
atmospheric pressure is shown (at sea level) as 14.7 psia or 100 kPa
respectively. The EA-D, EKA-D can display temperature in ºF or ºC.
A printer is an optional addition to the autoclave. The printer prints the preset
and actual parameters of the cycle (temperature, time and pressure).
The EA-D, EKA-D features built-in memory to record up to 100 sterilization
cycles. These can be reprinted on the optional printer or exported to a USB
device to be transferred to a PC.
The difference between the EA-D and the EKA-D is that in EKA-D is that in
EKA-D the complete cycle is quicker.
Caution!
Only technical personnel having proper qualifications and
holding technical documentation (including a technician
manual) and adequate information are authorized to service
the apparatus.
3.2. Specifications
2340 EA-D, EKA-D, 2840EA-D, EKA-D
Property
Value
2340 EA-D,
EKA-D
2840EA-D
Chamber
Dia.
230 mm
280 mm
Depth
440 mm
400 mm

Page 7
Property
Value
2340 EA-D,
EKA-D
2840EA-D
Chamber volume
19.8 lit
28.5 lit
Weight
42 kg
55 kg
Weight w/max solid load and full reservoir
52 kg
67 kg
Weight per support area (max. load)
According to overall weight and
floor loading requirements
Maximum load per item
0.5 kg
0.5 kg
Maximum load per tray
1.4 kg
1.4 kg
Maximum solid load
4.1 kg
6kg
Tray
dimensions
Small
W
170 mm
H
20 mm
L
415 mm
Max. Allowable Working pressure (MAWP)
2.8 bar
Max No. of trays
3
5
3850EA -D, 3870EA -D
Property
Value
3850EA -D
3870EA -D
Chamber
Dia.
380 mm
380 mm
Depth
490 mm
690 mm
Chamber volume
65 lit.
85 lit.
Weight
81kg
88 kg
Weight w/max solid load and full reservoir
92 kg
102 kg
Maximum load per item
0.5 kg
0.5 kg
Maximum load per tray
Unwrapped 5kgs
Unwrapped 6kgs
Maximum solid load
Unwrapped 10kgs
Unwrapped 12kgs
Tray
dimensions
Small
28 x 50 x 2.5cm
28 x 67 x 2.5cm
Big
35 x 50 x 2.5cm
35 x 67 x 2.5cm
Max. Allowable Working pressure (MAWP)
2.8bar
No. of trays
2
2

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3.3. Electrical Data
Model
Property
2340/2840
EA-D
2340/2840
EKA-D
3850EA-D
3870EA-D
Total Power
1400W
2200W
2400W
3000W
Voltage
230VAC / 1
ph
230VAC / 1
ph
230VAC /
1ph
230VAC /
1ph
Amperage
6A
9.6A
10.5A
13A
Protection against
electrical shock
Class I (IEC 60601-1)
Mains supply
fluctuation
+/- 10%
Degree of
protection by
enclosure
IP31
Caution!
In order to avoid any injury by electrical hazard, it is
recommended that a ground fault protection device (GFCI)
be installed in the electrical panel feeding the autoclave
(local codes may make this mandatory).
3.4. Utilities
Property
Value
Mineral free water
See table in 3.8
Power supply
* 1 phase, /230VAC ±10%, 50Hz
Recommended circuit breaker
15A
Note:
The electrical network must comply with local rules or regulations.
Verify that there is an easy access to the main power switch and to the current
leakage safety relay (GFCI). The voltage supplied to the device must comply
with the label ± 5%.
3.5. Environmental Emission Information
The peak sound level generated by the autoclave is 65dBa with
background noise of 48 dBa.
The total heat per hour transmitted by the autoclave is <200Wh.
3.6. Construction
The main parts of the autoclave are made of materials as indicated
below:
Chamber is built of stainless steel 316 L.
Door is made of stainless steel 316.

Page 9
Trays are made of stainless steel 304.
Water reservoir is made of polyethylene.
Door handle is made of hard plastic material, which is safe to touch and
thermo-insulated.
3.7. Stickers Description
Symbol
Meaning
Part Number
Location
Caution! Consult
accompanying
documents
LAB048-
0024
Near the main power
electric cable socket
Caution! Hot
surface.
LAB048-
0023
On the top cover
above the door and on
the rear cover above
the water strainer
Caution! Hot
steam.
LAB048-
0058
On the top cover near
the water reservoir
opening (hot steam
emerges out of the
safety valve located
inside the reservoir)
3.8. Water Quality
Physical Characteristics and Contaminants Levels
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 steam for sterilizers (According to EN 13060: 2010)
Element
Condensate – allowable
content
Silicon dioxide SiO2
≤0.1 mg/kg
Iron
≤0.1 mg/kg
Cadmium
≤0.005 mg/kg
Lead
≤ 0.05 mg/kg
All other metals except iron, cadmium, lead
≤0.1 mg/kg
Chloride (Cl)
≤0.1 mg/kg
Phosphate (P2O5)
≤0.1 mg/kg
Conductivity
≤3 μs/cm
pH value (degree of acidity)
5 to 7
Appearance
Colorless clean without
sediment
Hardness (Σ Ions of alkaline earth)
≤0.02 mmol/l

Page 10
Compliance with the above data should be tested in accordance with
acknowledged analytical methods, by an authorized laboratory.
3.9. Directives and Standards
Every autoclave meets the provisions of the following Directives and is in
compliance with the following Standards:
Tuttnauer. Ltd. company meets the provisions of the following standards:
ISO 13485:2003 (Quality Systems for Medical Devices)
ISO 9001:2008 (Quality Systems)
MDD 93/42/EEC (Medical Device Directive)
Tuttnauer. Ltd. company also works in conjunction with and refers to:
ANSI/AAMI ST55 American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels.
EN 13060 Small Steam Sterilizers.
UL UL 61010-1
PED 97/23EEC
IEC IEC 61010-2-040 Safety
ISO 17665-1:2006 (Validation and Routine Control)
3.10. Overall Dimensions –2340EA-D, EKA-D

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3.11. Overall Dimensions –2840EA-D, EKA-D
3.12. Overall Dimensions – 3850EA–D

Page 12
3.13. Overall Dimensions – 3870EA–D

Page 13
3.14. FRONT VIEW 2340EA-D, EKA-D, 2840EA-D, EKA-D
No.
Description
No.
Description
1
Drain
8
Safety valve
2
Door opening grip
9
Display
3
Door micro-switch
10
Keypad
4
Door cover
11
Autoclave power switch
5
Water filling funnel
12
Printer cover
6
Autoclave cover
13
Printer (option)
7
Mineral-free water reservoir
cover
5
4
3
7
8
11
9
10
13
12
6
2
1

Page 14
3.15. FRONT VIEW 3850EA-D, 3870EA-D
No.
Description
No.
Description
1
Door opening grip
7
Display
2
Door cover
8
Keypad
3
Autoclave cover
9
Printer cover
4
Mineral-free water reservoir cover
10
USB connector
5
Safety valve
11
Printer (option)
6
Chamber pressure gauge
12
Autoclave On/Off switch & circuit
breaker
3
2
1
4
5
8
6
7
9
11
12
10

Page 15
3.16. REAR VIEW 2340EA-D, EKA-D, 2840EA-D, EKA-D
No.
Description
No.
Description
1
Main power electric cable
socket
5
Mineral-free water reservoir
cover
2
Cut-off switch
6
Autoclave cover
3
Network port
7
Air filter cover
4
Ventilation grills
8
Water strainer
3.17. REAR VIEW 3850EA-D, 3870EA-D
No.
Description
No.
Description
1
Main power electric cable socket
5
Autoclave cover
2
Circuit breaker
6
Ventilation grills
3
RJ45 Network port
7
Air filter cover
4
Mineral-free water reservoir cover
8
Water outlet strainer
5
6
3
1
2
4
7
8
6
5
4
7
2
1
8
3
4

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4. CONTROL PANEL
2340EA-D, EKA-D, 2840EA-D, EKA-D
No.
Description
No.
Description
1
Display
4
USB Port
2
Main switch and circuit
breaker
5
Printer (option)
3
Keypad
3850EA-D, 3870EA-D
.
No.
Description
No.
Description
1
Autoclave pressure gauge
4
USB Port
2
Display
5
Printer (option)
3
Keypad
6
Main switch and circuit breaker
1
2
3
4
5

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4.1. Description and Functions of the Control panel
Display
The display is an LCD panel used to display the current status of the
autoclave and any Operational Messages or Error Messages.
Keypad
The keypad consists of 3 keys as described below:
UP key
This key has the following functions:
In the menu directories:
oThis key enables the operator to browse through the cycles.
In the directories available:
oWhen the cursor is blinking on a number, the UP ▲ key increases its
value.
oWhen the cursor is blinking on a menu selection, the UP ▲ key
allows browsing backward through the menu.
oWhen adjusting a parameter and the cursor is blinking on “SET” or
“EXIT” the UP ▲ key activates that procedure.
DOWN key
This key has the following functions:
In the menu directories:
oThis key enables the operator to browse through the cycles.In the
directories available:
oWhen the cursor is blinking on a number, the DOWN ▼ key
decreases its value.When the cursor is blinking on menu selection,
the DOWN ▼ key allows browsing forward through the menu.When
adjusting a parameter and the cursor is blinking on “SET” or “EXIT”
the
DOWN ▼ key activates that procedure.
Chamber
temperature
Chamber
pressure
System status
Name of stage
Error and operational messages
Program Parameters:
Sterilization temperature
Sterilization time
Drying Time
Program description:
Program icon and name

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START/STOP key
This key has the following functions:
In the main screen:
oStarts the process when the required program was chosen.
oStops the current process.
oCancels the Error message displayed on the screen and releases the
electric door lock.
In the menu directories:
oWhen the cursor is blinking on a number, the START/STOP key
enables moving to the next position.
oWhen the cursor is blinking on a menu selection, the START/STOP
key activates that selection.
Printer
The printer is an optional device. It prints the detailed history of each cycle
performed by the autoclave. The printing is on thermal paper with 24
characters per line. It records the sterilization cycle information for subsequent
consideration.
The printing is on thermal paper with 24 characters per line and contains the
following information:
Date:
Time:
Ser. Num:
Model:
Version:
Cycle Num:
Cycle:
Ster Temp:
Ster Time:
Dry Time:
End Temperature
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 from
the bottom up, beginning with the date and ending with "Cycle Ended". For an
aborted cycle, "Cycle Failed" and the Error message are printed (refer to
"Displayed Error Messages/ Symbols").
Printer Handling
Maintenance
Wipe off any soiling on the printer surface with a dry soft cloth
with a weak neutral detergent. After that, wipe the printer with a
dry cloth.