Tuttnauer 5050 User manual

Operation and
Maintenance Manual
Electronic Laboratory Autoclaves
Models 5050, 5075 ELV-MD/ELV-D
ELV-MD: standard autoclave (manual door)
ELV-D: standard autoclave (automatic door)
C: optional system for fast cooling
PV: optional vacuum pump
BH: optional bio hazard filtration
WR: water recycling system
F: optional fan for super-fast cooling
Cat. No. MAN205-0451001EN Rev I
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. General 4
1.1 Incoming Inspection 4
1.2 Warranty 4
1.3 Warranty Statement 4
1.4 Accessories 5
1.5 Introduction 5
2. Safety Instructions 8
3. Technical Data 10
3.1 Operating Conditions 10
3.2 Directives and Standards 10
3.3 Environmental Emission Information 11
3.4 Electrical Data 11
3.5 Water Quality 12
3.6 Specifications 13
3.7 Construction 14
3.8 Utilities 14
3.9 Stickers Description 16
3.10 Front View 17
3.11 Front View (WR Configuration, Inside Reservoir, Only Specific
Items Are Shown) 18
3.12 Rear View 19
3.13 Rear View (WR Configuration, Inside Reservoir, Only Specific
Items Are Shown) 20
3.14 Overall Dimensions -- model 5050ELV (mm) 21
3.15 Overall Dimensions – model 5075ELV 22
3.16 Overall Dimensions – model 5075ELV WR configuration 22
3.17 Safety Features include built-in safety features such as: 23
3.18 Description of Operation 23
4. Control Panel 25
4.1 Control Panel Drawing 25
4.2 Description and Functions of the Front Panel Keyboard 26
4.3 Displayed Error Messages / Symbols 28
4.4 Displayed operational messages / Symbols 28
5. Sterilization Programs 30
5.1 Program 1: Glass 33
5.2 Program 2: Plastic 34

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5.3 Program 3: Liquid A 35
5.4 Program 4: Liquid B – Waste 36
5.5 Program 5: Liquid A – Cooling (C – cooling models only) 37
5.6 Program 6: Liquid B – Waste Cooling (C – cooling models only)
38
5.7 Program 7: Bio Hazard 1 (BH, bio-hazard models only) 39
5.8 Program 8: Bio Hazard 2 (BH, bio-hazard models only) 40
5.9 Program 9: Bio Hazard Liquids (BH, bio-hazard models only) 41
5.10 Program 10: Vacuum Test (PV, pre-vacuum models only) 43
5.11 Program 11: Warm-Up 44
5.12 Program 12: Isothermal 45
5.13 Program 13: Air Mixture 46
5.14 Program 14: Glass Test 47
5.15 Program 15: Durham 48
6. Checking and Changing Parameters and Other Data 50
6.1 Browsing through the menus 50
6.2 Changing a Parameter 51
6.3 Quick options screen 53
6.4 Logging in and entering the Main menu 57
6.5 Changing parameters 58
6.6 System Parameters 59
6.7 Maintenance 60
6.8 Cycle parameters 61
7. Screens 63
7.1 Screens following a complete successfully cycle – "Cycle Ended"
63
7.2 Screens following aborted cycles after complete sterilization stage
63
7.3 Screens following a fail cycle: 64
8. Printer 66
8.1 Printer Output 66
8.2 Printer Handling 68
9. Preparation before Sterilization 71
9.1 Instruments 71
9.2 Liquids 72
9.3 Loading 72
10. Operation 73
10.1 Draining and filling the water reservoir (WR only). 73
10.2 Turning on the autoclave 74
10.3 Opening the door – MD models (mechanical door) 75
10.4 Opening the door – D models (automatic door) 75
10.5 Loading 76
10.6 Selecting program 77

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10.7 Closing and locking the door – MD models (mechanical door) 77
10.8 Closing and locking the door – D models (automatic door) 77
10.9 Starting a cycle 79
10.10................................................................................................Unloading 79
10.11............Stopping the process and cancelling the ERROR message 79
10.12................................................................... Start Cycle by Clock mode 80
10.13............................................................................Moving the Autoclave 80
10.14..................................................... Loading and Unloading the Device 80
11. Service and Maintenance 82
11.1 Preventive Maintenance 82
11.2 Replacing the Safety Valve – PED type 83
11.3 Replacing the Safety Valve -- ASME approved type 85
11.4 Checking the Safety Valve 85
12. Troubleshooting 87
13. Baskets and Containers 92
14. Spare Parts List 93
15. Accessories 93

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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 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!
1.3 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 Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800
GD Breda, The Netherlands
Tel: [phone], Fax: [phone]
Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY 11788
USA

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: [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.
1.4 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.
1.5 Introduction
Models 5050/5075 ELV-D/ELV-MD 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.
MD models have a manual door with handle, and D models have an
automatic door equipped with an electrical cylinder. The automatic door
locks itself when closed and unlocks .by pressing a button.
The sterilizer is fully automatic with a choice of five programs (including
two custom programs), eliminating any need for operator intervention
during a cycle. The custom programs are programs that may be
changed by an authorized technician. 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 blows off at 280
kPa (40 psi) (max. working pressure). The safety valve is located on
the rear of the autoclave. The control system provides adequate

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protection, to ensure the safety of personnel and reliable operation with
a minimum of down time.
On both 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/vacuum).
The autoclave is equipped with an analog 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.
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.
BH
In ELVCPVBH-D (bio-hazard) models, a bio-hazard filter installed in the
chamber enables sterilizing bio-hazard load without contaminating the
surrounding.

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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 in the following way:
Water inlet by the pump from the reservoir and not direct from the
plumbing.
On slow/fast exhaust, the water gets into the reservoir.
Note: Water reservoir may be located inside or outside.
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. 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.

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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 10.1).
17. This autoclave equipped with rear and front wheels, so when moving
the autoclave all utilities must be disconnected, At least 2 persons
shall move the autoclave with caution. When the autoclave is located
in the required place, the wheels have to be locked. For further
information see the front/rear view of the autoclave.

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3. Technical Data
3.1 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!
3.2 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:
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.

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EN 285 Large 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)
3.3 Environmental 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 < 600 W/h
3.4 Electrical Data
230V configuration
Property
Value: 5050
Value: 5075
Total Power
9000W
(3*3000W
9000W
(3*3000W
Voltage
3Ph, 230VAC
3Ph, 230VAC
Amperage
23A w/o PV,
25A with PV
23A 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: 5050
Value: 5075
Total Power
9000W
(3*3000W)
9000W
(3*3000W)
Voltage
3Ph, 400VAC
3Ph, 400VAC
Amperage
13A
13A
Protection against electrical
shock
Class I (IEC 60601-1)
Mains supply fluctuation
+/- 10%
Degree of protection by
enclosure
IP31

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3.5 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!

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3.5.1 Drain Cooling
The feed water supplied to the drain cooling must meet the following
requirements:
Hardness: 0.7 - 0.2 mmol/l.
Water temperature shall not exceed 15°C (59°F).
3.5.2 Reverse Osmosis
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 autoclaves.
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.
3.6 Specifications
Model
Property
5050
5075
Overall
dimensions
Height
870mm
1100mm
Width
870mm
870mm
Length
770mm
770mm
Overall
dimensions
(WR
configuration)
Height
1156mm
Width
859mm
Length
737mm

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Maximum
dimensions
(door open)
Width
960mm
960mm
Height
1460mm
1690mm (1759mm
for WR
configuration)
Net weight (kg)
175kg
192kg
Weight per support
area (max. load)
According to overall weight and
floor loading requirements
Shipping volume (m3)
1.35m3
1.35 m3
Shipping weight (kg)
210kg
227kg
Shipping
dimensions
length
1050m
1050m
width
920m
920m
height
1400m
1400m
Max. Allowable
Working pressure
(MAWP)
2.8bar
2.8
Chamber
diameter
500mm
500mm
Depth
500mm
750mm
Chamber Volume
110L
160L
3.7 Construction
Property
Value
Chamber and door material
Stainless steel
Outer Cabinet
Stainless Steel
Chamber insulation
Fiberglass with reinforced
material
Door handle (MD models).
Made of hard plastic material,
which is safe to touch and
thermo-insulated.
3.8 Utilities
3.8.1 Electrical utility
Power
Switch
box
Recommended
Circuit Breaker
208-220V (3 Ph + Earthing)
No
32A

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380-400V(3 Ph + Neutral +
Earthing)
No
16A
230V 1ph
yes
50A
Frequency
50/60Hz
3.8.2 Other utilities
Property
Value
Compressed Air (C,
cooling models only
only)
1/2" 3 Bar
Tap water
1/2", 2-6 Bar
Mineral free water
See table in sec. Error!
Reference source not found.
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.

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3.9 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

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3.10 Front View
No.
Description
No.
Description
1
Front leg
9
Display
2
Rear leg
10
Keyboard
3
Left service door
11
Printer cover
4
Left service door grip
12
Paper slot and paper cutter
5
Service door lock screws
13
Printer
6
Door cover
14
Main switch
7
Door handle (MD models
only)
15
USB socket
8
Pressure gauge
10
11
5
6
8
9
12
15
4
3
2
1
13
14
7

Page 18
3.11 Front View (WR Configuration, Inside Reservoir, Only
Specific Items Are Shown)
No.
Description
1
Glass tube indicator of the reservoir
water level
2
Inlet for manual water reservoir filling
2
1