Tuttnauer 3840 ELVG-D User manual

Operation and
Maintenance Manual
Electronic Laboratory Autoclaves
Models 3840, 3850, 3870 ELVG-D
ELVG-D: standard autoclave
C: optional system for fast cooling
PV: optional vacuum pump
BH: optional bio hazard filtration
F: optional fan for super-fast cooling
Cat. No. MAN205-0448004EN Rev H
Tuttnauer Europe B.V.,
Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda,
The Netherlands Tel: [phone], Fax: [phone]

https://tuttnauer.com/

Page 1
Table of Contents
Paragraph page no.
1. Generals................................................................................................... 4
1.1 Introduction ...................................................................................... 4
1.2 Incoming Inspection ......................................................................... 6
1.3 Warranty .......................................................................................... 6
1.4 Warranty Statement ......................................................................... 7
1.5 Accessories...................................................................................... 7
2. Safety Instructions.................................................................................... 8
3. Technical Data ....................................................................................... 10
3.1 Storage Conditions......................................................................... 10
3.2 Operating Conditions...................................................................... 10
3.3 Water Quality ................................................................................. 11
3.4 Reverse Osmosis........................................................................... 12
3.5 Directives and Standards ............................................................... 12
3.6 Environment Emission Information ................................................. 13
3.7 Electrical Data................................................................................ 13
3.8 Specifications................................................................................. 14
3.9 Construction................................................................................... 14
3.10 Utilities ........................................................................................... 15
3.11 Stickers Description........................................................................ 16
3.12 Front View...................................................................................... 17
3.13 Front View for the Fan Configuration .............................................. 18
3.14 Rear View ...................................................................................... 19
3.15 Overall Dimensions ........................................................................ 20
3.16 Safety Features.............................................................................. 21
4. Control Panel.......................................................................................... 22
4.1 Control Panel Drawing.................................................................... 22
4.2 Description and Functions of the Front Panel Keyboard ................. 23
4.3 Display screen................................................................................ 23
4.4 Keypad........................................................................................... 23
4.5 Printer ............................................................................................ 24
4.6 Displayed Error Messages / Symbols ............................................. 25
4.7 Displayed operational messages / Symbols.................................... 25
5. Sterilization Programs ............................................................................ 27
5.1 Program 1: Glass ........................................................................... 29
5.2 Program 2: Plastic.......................................................................... 30
5.3 Program 3: Liquid A........................................................................ 31
5.4 Program 4: Liquid B – Waste.......................................................... 32

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5.5 Program 5: Liquid A – Cooling (C – cooling models only) ............... 33
5.6 Program 6: Liquid B – Waste Cooling (C – cooling models
only) ............................................................................................... 34
5.7 Program 7: Waste (PV – pre-vacuum models only) ........................ 35
5.8 Program 8: Hollow Load (PV – pre-vacuum models only)............... 36
5.9 Program 9: Bio Hazard 1 (BH, bio-hazard models only).................. 37
5.10 Program 10: Bio Hazard 2 (BH, bio-hazard models only)................ 38
5.11 Program 11: Bio Hazard Liquids (BH, bio-hazard models only) ...... 39
5.12 Program 12: Vacuum Test (PV, pre-vacuum models only).............. 40
5.13 Program 13: Bowie and Dick Test (PV – pre-vacuum models
only) ............................................................................................... 41
5.14 Program 14: Warm-Up ................................................................... 42
5.15 Program 15: Isothermal.................................................................. 43
5.16 Program 16: Air Mixture.................................................................. 44
5.17 Program 17: Glass Test.................................................................. 45
5.18 Program 18: Durham...................................................................... 46
6. Screens.................................................................................................. 48
6.1 Screens following a completely successful cycle – "Cycle
Ended" ........................................................................................... 48
6.2 Screens following aborted cycles after complete sterilization
stage .............................................................................................. 49
6.3 Canceled by user after complete sterilization stage ........................ 49
6.4 Pressure Time Error Failure occurrence after complete
sterilization stage ........................................................................... 49
6.5 Screens following a fail cycle:......................................................... 49
6.6 Failure according to Pressure Time Error ....................................... 50
6.7 Failure according to Cancellation by user before complete
sterilization stage ........................................................................... 50
7. Checking and Changing Parameters and Other Data ............................. 51
7.1 Browsing through the menus .......................................................... 51
7.2 Changing a Parameter ................................................................... 52
7.3 Quick options screen...................................................................... 54
7.4 Logging in and entering the Main menu.......................................... 58
7.5 Changing parameters..................................................................... 59
7.6 System Parameters........................................................................ 60
7.7 Maintenance................................................................................... 60
7.8 Cycle parameters ........................................................................... 62
8. Printer .................................................................................................... 64
8.1 Printer Output................................................................................. 64
8.2 Printer Handling ............................................................................. 67
8.3 Treating the thermal papers:........................................................... 69
9. Preparation before Sterilization............................................................... 70
9.1 Instruments .................................................................................... 70

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9.2 Liquids............................................................................................ 71
9.3 Tubing............................................................................................ 72
9.4 Loading .......................................................................................... 72
10. Operating Instructions ............................................................................ 73
10.1 Turning on the autoclave ................................................................ 73
10.2 Opening the door............................................................................ 73
10.3 Loading .......................................................................................... 74
10.4 Selecting the program .................................................................... 74
10.5 Closing and locking the door .......................................................... 75
10.6 Starting cycle.................................................................................. 76
10.7 Unloading....................................................................................... 78
10.8 Stopping the process and cancelling the ERROR message............ 79
10.9 Start Cycle by Clock mode ............................................................. 79
10.10 ........................................................................... Moving the Autoclave79
10.11 ...................................................... Loading and Unloading the Device80
11. Service and Maintenance Instructions .................................................... 81
11.1 Preventive and Scheduled Maintenance......................................... 81
11.2 Daily............................................................................................... 81
11.3 Weekly ........................................................................................... 81
11.4 Periodically..................................................................................... 82
11.5 Periodical Tests.............................................................................. 82
11.6 Replacing the Safety Valve – PED type.......................................... 82
11.7 Replacing the Safety Valve -- ASME approved type ....................... 84
11.8 Checking the Safety Valve ............................................................. 84
12. Troubleshooting...................................................................................... 86
13. Baskets and Containers.......................................................................... 91
14. Spare Parts List...................................................................................... 92
15. Accessories............................................................................................ 92

Page 4
1.Generals
1.1 Introduction
Model 3870 ELCPVG is a laboratory sterilizer designed especially
for the sterilization of instruments, liquids, and other materials in
hospital laboratories, medical laboratories, research institutes, food
laboratories and pharmaceutical facilities.
Special feature of ELCPV-D model 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.
In BH (bio-hazard) models, a bio-hazard filter installed in the
chamber enables sterilizing bio-hazard load without contaminating
the surrounding.
There is a configuration equipped with fan that allows shortening
the cooling operation.
The temperature and pressure are controlled through sensors
placed inside and outside the media container or bottles.
The autoclave is equipped with A 9Kw generator that produces the
steam required for the sterilization.
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.
In bio-hazard models (BH in their model name), a bio-hazard filter
installed in the chamber enables sterilizing bio-hazard load without
contaminating the surrounding.

Page 5
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
(programs 9-10 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 6
Only technical personnel having proper qualifications,
holding technical documentation and adequate test
instrumentation are authorized to undertake repair or
service.
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!

Page 7
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:
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 or a new steam generator
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

Page 9
bottles on the floor of the autoclave. Never fill more than 2/3 of
the bottle volume.
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.

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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.
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!

Page 11
3.3 Water Quality
The distilled or mineral-free water supply shall be according to the
table below:
Physical Characteristics and Maximum acceptable
contaminants levels in water or steam, for steam generator
and sterilizers
Contaminants in
water supplied to
generator/chamber
Contaminants in
condensate at steam
inlet to sterilizer
Evaporate residue
≤ 10 mg/l
N/A
Silicate (SiO2)
≤ 1 mg/l
≤ 0.1 mg/l
Iron
≤ 0.2mg/l
≤ 0.1mg/l
Cadmium
≤ 0.005 mg/l
≤ 0.005 mg/l
Lead
≤ 0.05 mg/l
≤ 0.05 mg/l
Rest of heavy metals
except iron,
cadmium, lead
≤ 0.1 mg/l
≤ 0.1 mg/l
Chloride (Cl)
≤ 2 mg/l
≤ 0.1 mg/l
Phosphate (P2O5)
≤ 0.5 mg/l
≤ 0.1 mg/l
Conductivity (at
25°C)
3 to 15 µs/cm
≤ 3 µs/cm
pH value (degree of
acidity)
5 to 7.5
5 to 7
Hardness (Σ ions of
alkaline earth)
≤ 0.02 mmol/l
≤ 0.02 mmol/l
Appearance
Colorless, clean, without sediments
Compliance with the above data should be tested in accordance
with acknowledged analytical methods, by an authorized
laboratory.
Attention:
The use of water for autoclaves that do not comply with the
table above may have severe impact on the working life of the
sterilizer and can invalidate the manufacturer’s guarantee.
Use only deionized water, having a maximum conductivity of
15 µs/cm. Conductivity greater than 15 µs/cm may cause
failures.
Tap water supply
The range of hardness value 0.7-2.0 mmol/l (70- 200 mg/l
CaCO3)
The use of soft water is strictly forbidden!
Please consult a water specialist!

Page 12
3.4 Reverse Osmosis
A Reverse Osmosis system may be used to improve the quality of
the water used to generate steam in the autoclave chamber. The
use of mineral free will contribute to better performance and longer
life of the autoclave.
A Reverse Osmosis (RO) system may be used to improve the
quality of the water used to generate steam in the autoclave
chamber.
In RO, the water is forced through a semi-penetrable membrane,
which filters out contaminants to a high degree of efficiency. In
deionisation (DI) ions and charged particles are removed either by
electric fields or by ion exchange in resin beds.
Although the RO cannot normally attain the degree of purity
possible with the DI methods, it is more than adequate for the feed
water intended for clean-steam generators.
Moreover the RO has several advantages:
1. RO is cheaper to install and to run than DI.
2. RO removes particulate matter, organic molecules and pyrogens
that DI cannot remove
3. RO water is less corrosive to steel and copper than DI water.
4. RO maintenance requirements are less demanding than those of
the DI units.
Therefore the use of mineral free water will contribute to better
performance and longer life of the autoclave.
3.5 Directives and Standards
Every autoclave meets the provisions of the following Directives
and is constructed in compliance with the following Standards:
Tuttnauer. Ltd. company meets the provisions of the following
standards:
EN ISO 13485:2012 (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:
AAMI/ANSI-ST8 Hospital sterilizers
ASME American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels

Page 13
EN 13060 Small Steam Sterilizers
UL UL 61010-1
PED 97/23EEC
IEC IEC 61010-2-040 Safety
IEC IEC 61326-1 EMC
ISO 17665-1:2006 (Validation and Routine Control)
3.6 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 < 450 W/h
3.7 Electrical Data
230V configuration
Property
Value: 3840
Value: 3850
Value: 3870
Total Power
9000
9000
9000
Voltage
3Ph,
230VAC
3Ph,
230VAC
3Ph,
230VAC
Amperage
22A w/o PV,
25A with PV
22A w/o PV,
25A with PV
22A w/o PV,
25A with PV
Protection against electrical shock
Class I (IEC 60601-1)
Mains supply fluctuation
+/- 10%
Degree of protection by enclosure
IP31
400V configuration
Property
Value: 3840
Value: 3850
Value: 3870
Total Power
9000
9000
9000
Voltage
3Ph, 400VAC
3Ph, 400VAC
3Ph, 400VAC
Amperage
13A w/o PV,
16A with PV
13A w/o PV,
16A with PV
13A w/o PV,
16A with PV
Protection against electrical
shock
Class I (IEC 60601-1)
Mains supply fluctuation
+/- 10%
Degree of protection by
enclosure
IP31

Page 14
3.8 Specifications
Model
Property
3840
3850
3870
Overall
dimensions
Height
1000mm
1000mm
1000mm
Width
730mm
730mm
730mm
Length
700mm
700mm
700mm
Maximum
dimensions
(door open)
Width
800mm
800mm
800mm
Height
1050mm
1050mm
1050mm
Net weight
162kg
162kg
162kg
Shipping volume
1.36
1.36
1.36 m3
Shipping weight
197kg
197kg
197kg
Shipping
dimensions
length
1050mm
1050mm
1050mm
width
920mm
920mm
920mm
height
1410mm
1410mm
1410mm
Max. Allowable
Working pressure
(MAWP)
2.8 bar
2.8 bar
2.8 bar
Chamber
diamet
er
380mm
380mm
380mm
Depth
400mm
490mm
690mm
Chamber Volume
52L
65L
85L
Load No. counter
Counting from 0 to 3000 and
nullifies.
3.9 Construction
Chamber and door
material
Stainless steel
Outer Cabinet
Stainless Steel
Chamber insulation
Fiberglass with reinforced
material

Page 15
3.10 Utilities
Electrical utility
Power
Switch
box
Recommended
Circuit Breaker
208-220V (3 Ph + Earthing)
No
20A
380-400V(3 Ph + Neutral +
Earthing)
No
16A
230V 1ph
yes
32A
Frequency
50/60Hz
Other Utilities
Compressed Air
(ELVCPVG-D only)
1/2" 3 Bar (44-58 psi)
Tap water
1/2", 2-6 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 16
3.11 Stickers Description
Symbol
Meaning
Part Number
Location
Caution! Hot
steam.
LAB048-0058
Near the safety
valve
Protective earth
(Ground)
LAB048-0020
Near the earthing
screw
Caution! Hot
surface.
LAB048-0023
On the rear cover
above the water
strainer
Press & Hold
Until “System
Ready” is
Displayed = 10
sec.
LAB048-0461
(Automatic
door only)
On the door right
edge
Don’t Touch
Microswitches
please Contact
Tuttnauer
Service
LAB048-0462
On the door frame
behind the door
cover
Don’t Touch
Microswitches
please Contact
Tuttnauer
Service
LAB048-0463
On the door frame
behind the door
cover
ON
OFF
On-Off
LAB048-0018
Near the Power
switch

Page 17
3.12 Front View
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 18
3.13 Front View for the 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