Tuttnauer 3840 ELV Manual

Operation &
Maintenance
Manual
Laboratory Vertical Steam Sterilizers
Including Fast Cooling System
models 3840, 3850, 3870
ELV/WR/C/PV/BH/F-D
Cat. No. MAN205-0448002EN Rev F
Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda, P.O. Box 7191, 4800 GD
Breda, Netherlands. +31/76-5423510, Fax: [phone]

Page 1
TABLE OF CONTENTS
PARAGRAPH PAGE NO.
1. GENERAL............................................................................................................4
1.1 Introduction............................................................................................... 4
1.2 Incoming Inspection................................................................................6
1.3 Warranty.....................................................................................................6
1.4 Warranty Statement................................................................................. 6
1.5 Accessories .............................................................................................. 7
2. SAFETY INSTRUCTIONS ................................................................................. 8
3. TECHNICAL DATA .......................................................................................... 10
3.1 Storage Conditions ............................................................................... 10
3.2 Operating Conditions............................................................................ 10
3.3 Directives and Standards..................................................................... 10
3.4 Environment Emission Information................................................... 11
3.5 Electrical Data......................................................................................... 11
3.6 Specifications ......................................................................................... 12
3.7 Construction ........................................................................................... 12
3.8 Utilities ..................................................................................................... 13
3.9 Symbol Description............................................................................... 14
3.10 Description of Operation......................................................................22
3.11 Water Quality .......................................................................................... 24
3.12 Safety Features ...................................................................................... 25
4. CONTROL PANEL ........................................................................................... 26
4.1 Description and Functions of the Front Panel Keyboard............. 27
4.2 Displayed Error Messages / Symbols ............................................... 29
4.3 Displayed operational messages / Symbols ...................................30
5. STERILIZATION PROGRAMS ....................................................................... 31
6.3 Program 1: Glass ................................................................................... 32
6.4 Program 2: Plastic ................................................................................. 34
6.5 Program 3: Liquid A .............................................................................. 35
6.6 Program 4: Liquid B – Waste .............................................................. 36
6.7 Program 5: Liquid A – Cooling (C – cooling models only)........... 37
6.8 Program 6: Liquid B – Waste Cooling (C – cooling models only)38
6.9 Program 7: Bio Hazard 1 (BH, bio-hazard models only)............... 39
6.10 Program 8: Bio Hazard 2 (BH, bio-hazard models only)............... 40
6.11 Program 9: Bio Hazard Liquids (BH, bio-hazard models only) ...41
6.12 Program 10: Vacuum Test (PV, pre-vacuum models only) .......... 42
6.13 Program 11: Warm-Up .......................................................................... 43
6.14 Program 12: Isothermal ........................................................................ 44
6. CHECKING AND CHANGING PARAMETERS AND OTHER DATA .......46
6.1 Quick options screen............................................................................ 46

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6.2 Entering the main menu ....................................................................... 57
6.3 Directories and subdirectories ........................................................... 59
6.4 Cycle Parameters (Custom program = duplicate cycle) ............... 59
6.5 System Parameters ............................................................................... 67
6.6 Maintenance............................................................................................ 70
7. SCREENS.......................................................................................................... 76
7.1 Screens following a complete successfully cycle – "Cycle Ended"
.................................................................................................................... 76
7.2 Screens following aborted cycles after complete sterilization
stage ......................................................................................................... 76
7.3 Screens following a fail cycle:............................................................ 77
8. PRINTER ........................................................................................................... 78
8.1 Printer Output ......................................................................................... 78
8.2 Printer Handling ..................................................................................... 80
9. PREPARATION BEFORE STERILIZATION ................................................ 83
9.1 Instruments ............................................................................................. 83
9.2 Liquids...................................................................................................... 84
9.3 Loading ....................................................................................................84
10. OPERATION ..................................................................................................... 86
10.1 Filling the water reservoir (WR configuration only) ...................... 86
10.2 Turning on the autoclave ..................................................................... 86
10.3 Opening the door ................................................................................... 87
10.4 Loading ....................................................................................................88
10.5 Closing the door .................................................................................... 88
10.6 Starting cycle.......................................................................................... 89
10.7 Unloading ................................................................................................ 90
10.8 Stopping the process and cancelling the ERROR message .......91
10.9 Start Cycle by Clock mode .................................................................. 91
10.10................................................................................. Moving the Autoclave
.................................................................................................................... 91
10.11......................................................... Loading and Unloading the Device
.................................................................................................................... 91
11. DOOR SAFETY SYSTEM ............................................................................... 92
11.1 Electric door locking system .............................................................. 92
11.2 Pressure switch...................................................................................... 93
12. SERVICE AND MAINTENANCE .................................................................... 94
12.1 Preventive Maintenance ....................................................................... 94
12.2 Checking the Safety Valve ...................................................................95
12.3 Draining the Reservoir.......................................................................... 97
13. TROUBLESHOOTING ..................................................................................... 98
14. SPARE PARTS LIST ..................................................................................... 103
15. ACCESSORIES .............................................................................................. 103

Page 3
TABLE OF CONTENT (Cont.)
DRAWINGS PAGE NO.
FRONT VIEW (STANDARD CONFIGURATION) .......................................15
FRONT VIEW (WR CONFIGURATION) .....................................................16
FRONT VIEW (FAN CONFIGURATION)....................................................17
REAR VIEW (STANDARD CONFIGURATION) .........................................18
REAR VIEW (WR CONFIGURATION) .......................................................19
OVERALL DIMENSIONS (STANDARD CONFIGURATION, mm) ............. 20
OVERALL DIMENSIONS (WR CONFIGURATION, mm) ...........................21
CONTROL PANEL DRAWING...................................................................26
BASKETS AND CONTAINERS ............................................................... 102

Page 4
1. GENERAL
1.1 Introduction
A computerized control unit ensuring a fully automatic
sterilization cycle controls the autoclave.
The temperature and pressure are controlled through sensors
placed inside and outside the media container or bottles.
The sterilizer is fully automatic with a choice of 10 programs,
eliminating any need for operator intervention during a cycle
program 7 are for vacuum test only). A computerized control
unit enables precise control and monitoring of physical
parameters and clear documentation of the sterilization cycles.
The autoclave is equipped with a safety valve, which will
discharge at an overpressure of over 2.8 Bar (40 psi), which is
located on the chamber near the pressure switch and the steam
pressure gauge. The control system provides adequate
protection, to ensure the safety of personnel and reliable
operation with a minimum of down time.
The sterilizer has multiple built - in safety devices, which
provides adequate protection to ensure the safety of operating
personnel.
On all models, 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 autoclave is provided with a pressure gauge that is used as
guide only. Should there be a power failure during the operation
of the autoclave, the pressure gauge indicates to the operator
that there is pressure in the chamber.
A deviation of +1.6% is accepted.
NOTE:
After operating the sterilizer, brown stains might appear on the
bottom of the chamber. These stains are a result of the heating
elements that are located at the lower external part of the
chamber. The brown color is a common phenomenon, can easily
be removed, and will not have any effect on the sterilized goods.
This manual is intended to give the user a general
understanding of how the autoclave works and indicates the best
ways to operate and take care of it in order to obtain optimum
results and a trouble-free operation. After reading this manual,
operating the autoclave should be straightforward. 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 recalibrate it.

Page 5
Only technical personnel having proper qualifications,
holding technical documentation and adequate test
instrumentation are authorized to undertake repair or
service.
Available optional configurations
Models of 3870 ELV model range -D are laboratory sterilizers
designed especially for the sterilization of instruments, liquids,
and other materials in hospital laboratories, medical laboratories,
research institutes, food laboratories and pharmaceutical
facilities.
C
A special feature of the ELVC-D models is the fast cooling stage
for liquids. In this stage pressure in the chamber is increased by
means of compressed air to compensate the fast decreasing of
pressure due to the fast cooling. The fast cooling shortens the
time required for safe handling of bottles.
Note: there is no cooling option for WR configuration
PV
Special feature of ELVCPV-D models is the vacuum pump that
enables air removal prior to sterilization and during the drying
stage.
The advantages of the pre-vacuum sterilizer in comparison to
the regular gravity displacement steam sterilizer are as follows:
— Removal of air pockets from packs and porous loads and
most kinds of tubes (rubber, plastic etc.) by vacuum at the
first stage of the cycle.
— Better steam penetration into the load; resulting in effective
sterilization.
— Better temperature uniformity.
— Better drying of materials with closed doors due to the
vacuum achieved in the chamber at the end of the
sterilization cycle.
A special feature of the autoclave is the fast cooling stage for
liquids. In this stage pressure in the chamber is increased by
means of compressed air to compensate the fast decreasing of
pressure due to the fast cooling. The fast cooling shortens the
time required for safe handling of bottles
There is a configuration equipped with fan that allows to shorten
the cooling operation.

Page 6
BH
In ELVCPVBH-D (bio-hazard) models, a bio-hazard filter
installed in the chamber enables sterilizing bio-hazard load
without contaminating the surrounding.
WR
In ELVWR-D (Water recycling) models, water is saved by the
water saving system, because it recycles the water and re-uses
it for each cycle.
1.2 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.
1.3 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 sec. 12.1 (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 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!
1.4 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:

Page 7
Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-
5423510,
Fax: [phone], E-mail: [e-mail]
Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY
11788, USA
: [phone], [phone], Fax: [phone]
e-mail:[email protected].
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.
1.5 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

Page 8
2. SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand
the operation instructions before first operation of the autoclave. The
following issues may require instructions guidance provided by the
manufacturer: how to operate the autoclave, the door safety
mechanism, the dangers involved in circumventing safety means, how
to ensure that the door is closed, and how to select a correct
sterilization program.
Make sure that you know where the main power switch is, where the
water cut-off valve is and where the compressed air disconnection
valves (if applicable) are located.
Autoclave maintenance is crucial for the correct and efficient function of
the device. We enclose a log booklet that includes maintenance
recommendations, with every device.
The weekly spore test is part of the preventive maintenance plan, along
with the annual validation of the sterilization processes that ensures
appropriate temperature dispersion within the chamber.
Never use the autoclave to sterilize corrosive products, such as: acids,
bases and phenols, volatile compounds or solutions such ethanol,
methanol or chloroform nor radioactive substances.
1. Never start using a new autoclave before the safety, licensing
and authorization department has approved it for use.
2. All autoclave users must receive training in proper usage from
an experienced employee. Every new employee must undergo a
training period under an experienced employee.
3. A written procedure must be established for autoclave operation,
including: daily safety tests, seal inspection and door hinge
inspection, smooth action of the closing mechanism, chamber
cleaning, prevention of clogging and preservation from corrosion,
what is permitted and what is prohibited for sterilization and
choosing a sterilization program.
4. Liquids may be sterilized only with the “liquids” programs. The
container must be covered but not sealed. Sealed bottles may
only be sterilized using a special program. The bottle must be
either Pyrex or a Borosilicate glass bottle. Verify that the two
temperature sensors are located inside two different bottles to
assure that the liquid temperature is 20°C below boiling
temperature for sealed bottles at the end of the cycle.
5. 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.
6. Individual glass bottles may be placed within an appropriate
container that will be placed in a basket. Never place glass
bottles on the floor of the autoclave. Never fill more than 2/3 of
the bottle volume.

Page 9
7. On closing the autoclave's door, make sure it is properly locked
before activating.
8. Before withdrawing baskets, wear heat resistant gloves.
9. Before opening the door, verify that there is no pressure in the
chamber (chamber pressure gauge is located on the autoclave's
front panel or door, depends on model).
10. Open the door slowly to allow steam to escape and wait 5
minutes before you remove the load. When sterilizing liquids,
wait 10 minutes.
11. Once a month, ensure that the safety valves are functioning, and
once annually a certified tester must conduct pressure chamber
safety tests.
12. Once annually, or more frequently, effective tests must be
performed, i.e., calibration and validation.
13. Examine the condition of assemblies on a regular basis. Make
sure there are no leaks, breaks, blockages, whistles or strange
noises.
14. It is required to conduct maintenance operations as instructed.
15. Immediately notify the person in charge of any deviation or risk
for the proper function of the device.
16. For WR models, drain the water from the mineral free water
reservoir once a week, and refill with fresh mineral-free water or
distilled water (see sec. 12.3).
17. This autoclave equipped with rear and front wheels, when
moving the autoclave all utilities must be disconnected, at least 2
persons shall move the autoclave with caution. When the
autoclave located in the required place, the wheels have to be
locked. For further information see the front/rear view of the
autoclave.

Page 10
3. TECHNICAL DATA
3.1 Storage Conditions
The packed or unpacked autoclave shall be retained in
indoor conditions!
3.2 Operating Conditions
The autoclave is intended to work in ‘indoor’ conditions only.
Only autoclavable materials shall be used.
The environment shall not exceed an ambient temperature
range of 5ºC (41ºF)-40ºC (104ºF) and a relative humidity
of 85% respectively.
The operation altitude shall not be over 2000 meters (6561
feet) (ambient pressure shall not be lower than 80 kPa (11.6
psi)).
The autoclave shall not be used in a manner not specified in
this manual!
Do not use the autoclave in the presence of dangerous
gases.
The packed or unpacked device shall be stored in ‘indoor’
conditions.
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 i.e. only non-hazardous
liquids shall be disposed in public sewage!
3.3 Directives and Standards
Every autoclave meets the provisions of the following Directives
and is constructed in compliance with the following Standards:
3.3.1 Technical Standards
1. AAMI/ANSI ST 8.
2. ASME Code Sec. VIII for Pressure Vessels.
3. Pressure Equipment Directive 97/23/EEC.

Page 11
4. EN 285:2006 ― Sterilization, Steam sterilizers,
Large sterilizers
5. IEC/UL 61010A-1 ― electrical equipment for
laboratory use; general requirements.
6. IEC 61010-2-040 ― particular requirements for
sterilizers and washer disinfectors used to treat
medical materials.
7. ISO 17665 ― 1:2006 Sterilization of health care
products moist heat.
3.3.2 Quality standards
The manufacturing plant meets the following quality
standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical
devices.
3.4 Environment Emission Information
A. Peak sound level generated by the sterilizer is «70 / dBA
with a back sound level of 60 dBA.
B. Total heat transmitted by the sterilizer is < 100 W/h
3.5 Electrical Data
3-phase autoclave
PROPERTIES
208V
version
230V
version
400V
version
Ampere (A)
14A
15A
9A
Voltage (V)
208V/3ph
230V/3ph
400V/3ph
Hertz (Hz)
50/60 Hz
50/60 Hz
50/60 Hz
Heaters power (W)
6000
6000
6000
Protection against electrical
shock
Class I
Class I
Class I
Degree of protection by
enclosure
IP31
IP31
IP31
1-phase autoclave
PROPERTIES
230V version
Ampere (A)
14.4A
Voltage (V)
230V/1ph
Hertz (Hz)
50/60 Hz

Page 12
Heaters power (W)
3300
Protection against electrical shock
Class I
Degree of protection by enclosure
IP31
3.6 Specifications
PROPERTIES
MODEL
3840
3850
3870
Chamber diameter
380 (15”)
380 (15”)
380 (15”)
Chamber depth
400 (15.8”)
480 (18.9”)
680 (26.8”)
Effective Chamber volume
52 liters. (11
US gal.)
65 liters. (17
US gal.)
85 liters. (22
US gal.)
Overall
dimensions
Height
847 (33.3”)
847 (33.3”)
996 (39.2”)
Width
727 (28.6”)
727 (28.6”)
727 (28.6”)
Length
500 (19.7”)
500 (19.7”)
500 (19.7”)
Maximum
dimensions
(door open)
Width
782 (30.8”)
782 (30.8”)
812 (32.0”)
Length
1336 (52.6”)
1336 (52.6”)
1486 (58.5”)
Mineral-free
water reservoir
Max.
water
volume
28 litres
(7.4 US gal.)
Min.
water
volume
Net weight (kg)
83 kg
(183 lbs)
85 kg
(187 lbs)
100 kg
(220 lbs)
Shipping volume
0.56 m3(17.98
ft3)
0.56 m3(17.98
ft3)
0.56 m3
(17.98 ft3)
Shipping weight
99 kg (218 lbs)
101 kg (222
lbs)
116 kg (255
lbs)
Max. Allowable Working
pressure (MAWP)
2.8 bar (40 psi)
3.7 Construction
Chamber and door material
Stainless steel
Outer Cabinet
Stainless Steel
Chamber insulation
Fiberglass with reinforced material
Water reservoir
Stainless Steel

Page 13
3.8 Utilities
3.8.1 Electrical utility
Power
Switch box
Recommended
Circuit Breaker
208-220V (3 Ph + Earthing)
No
20A
400V(3 Ph + Neutral +
Earthing)
No
16A
230V 1ph
No
16A
Frequency
50/60Hz
3.8.2 Other Utilities
Compressed Air (ELVC
only)
1/2" 3-4 Bar (44-58 psi)
Tap water
1/2", 2-3 Bar (29-44 psi)
Mineral free water
1/2", 2-3 Bar (29-44 psi)
Drain
2" Minimum Withstanding
temp. of 80°C (176°F)
Attention:
A switch or circuit-breaker must be included in the building
installation. This switch or circuit-breaker shall be in close
proximity to the equipment, within easy reach of the
operator; and marked as the disconnecting device for the
equipment.
The electrical net must be protected with a current leakage
safety relay.
The electrical network must comply with local rules or
regulations.
Verify that there is an easy access to the main power switch,
to the water cut-off valve and to the current leakage safety
relay.
Make sure while placing the autoclave, to leave space
around the machine, to give the technician access to service
the machine.
All water connections to autoclave must be performed
through "BACK FLOW PREVENTION SYSTEM" only, as per
IEC 61770.

Page 14
3.9 Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
On-Off

Page 15
FRONT VIEW (STANDARD CONFIGURATION)
No.
Description
1
Front leg
2
Rear leg
3
Left service door
4
Left service door grip
5
Left service door lock
6
Door cover
7
Pressure gauge
8
Display
9
Keyboard
10
Printer cover
11
Paper slot and paper cutter
12
USB socket
13
RJ45 connector
14
Main switch
15
Printer
9
10
5
6
7
8
11
14
15
4
3
2
1
12
13

Page 16
FRONT VIEW (WR CONFIGURATION)
No.
Description
1
Front leg (with brakes)
2
Rear leg
3
Front service door
4
Right service door grip
5
Right service door lock
6
Door cover
7
Pressure gauge
8
Display
9
Paper slot and paper cutter
10
Printer cover
11
Keyboard
12
USB socket
13
RJ45 connector
14
Printer
15
Main switch
9
10
5
6
7
8
11
14
15
4
3
2
1
12
13

Page 17
FRONT VIEW (FAN CONFIGURATION)
There is a configuration equipped with a fan that allows to shorten the
cooling operation. The fan is located on the door of the autoclave.
Fan

Page 18
REAR VIEW (STANDARD CONFIGURATION)
No.
Description
1
Drain outlet
2
Mineral free water inlet
3
Compressed air inlet
4
Cavitation port
5
Power supply electrical cord
6
Cut-off
7
Fan grill
8
Safety Valve
9
Circuit breaker
10
Ground connector
11
City (tap) water inlet for cooling coil
12
Air pressure gauge
13
Air pressure regulator
5
6
4
3
2
1
12
13
10
11
7
8
9