Tuttnauer 1730EK, 2340E, 1730E, 2340EKA, 2540E Operation & Maintenance Manual
...
OPERATION
&
MAINTENANCE
MANUAL
Electronic Tabletop Autoclaves
Models 1730, 2340, 2540, 3140, 3850, 3870
E, EK, EA & EKA
1
TABLE OF CONT E N T S
PARAGRAPH PAGE NO.
1.
GENERAL..............................................................................................................
4
1.1 Incoming Inspection .................................................................................. 4
1.2 Warranty..................................................................................................... 4
1.3 Warranty Statement.................................................................................... 4
2 TECHNICAL DATA.............................................................................................. 6
2.1 Introduction................................................................................................ 6
2.2 Standby Heating Mode............................................................................... 6
2.3 Environmental Emission Information...................................................... 6
2.4 Operating Conditions................................................................................. 7
2.5 Utilities........................................................................................................ 7
2.6 Construction ............................................................................................... 7
2.7 Symbol Description .................................................................................... 7
2.8 Electrical Data............................................................................................ 8
2.9 Specifications.............................................................................................. 9
2.10 Technical Specifications .......................................................................... 10
2.11 Directives and Standards.......................................................................... 11
2.12 Water Quality............................................................................................ 12
3 KEYBOARD (Keys and Display)......................................................................... 15
3.1 Indicator Light Description ..................................................................... 17
3.2 Description and Functions of the Control Panel Keyboard................... 18
3.3 Description of the Display Panel ............................................................. 20
3.4 Description of Displayed Messages and Safety Measures...................... 20
4 STERILIZATION PROGRAMS......................................................................... 23
4.1 PROGRAM 1. Unwrapped Instruments.................................................. 23
4.2 PROGRAM 2. Wrapped Instruments and Porous Loads....................... 24
4.3 PROGRAM 3. Glassware......................................................................... 25
4.4 PROGRAM 4. Accessory (Dry Only)...................................................... 25
5 PRINTER (Optional)........................................................................................... 26
5.1 Printer Operation ..................................................................................... 26
5.2 Printer Handling ...................................................................................... 28
6 INSTALLATION INSTRUCTIONS................................................................... 29
6.1 Electrical................................................................................................... 29
6.2 Automatic Water Filling .......................................................................... 31
6.3 Lifting and Carrying ................................................................................ 32
6.4 Loading and Unloading the Device......................................................... 33
6.5 Filling the Water Reservoir...................................................................... 33
7 PREPARATION BEFORE STERILIZATION.................................................. 34
8 OPERATING INSTRUCTIONS......................................................................... 37
2
TABLE OF CONT E N T S ( C o n t i n u e d )
PARAGRAPH PAGE NO.
9 MAINTENANCE INSTRUCTIONS................................................................... 40
9.1 Preventive and Scheduled Maintenance ................................................. 40
9.2 Replacing the Air Filter (Models EA, EKA) ........................................... 41
9.3 Draining the Reservoir............................................................................. 42
9.4 Cleaning the Air Jet ................................................................................. 43
9.5 Replacing the Door Gasket ...................................................................... 44
9.6 Checking the Safety Valve........................................................................ 45
9.7 Replacing the Fuse................................................................................... 46
9.8 Cleaning Water Outlet Strainer............................................................... 47
9.9 Cleaning Tabletop Autoclaves with Chamber Brite ™ .......................... 48
9.10 Water Sensor Cleaning ............................................................................ 50
10 TROUBLESHOOTING FOR THE OPERATOR .............................................. 51
3
TABLE OF CONT E N T S ( C o n t i n u e d )
DRAWINGS PAGE NO.
Front View.................................................................................................................................. 13
Rear View....................................................................................................................................14
Front Panel Keyboard – Old Type (Gray)................................................................................. 15
Front Panel Keyboard – New Type (Blue)................................................................................ 16
4
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
theycanfileaclaimwith 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.
Note: Lifting and carrying should always be done by two people.
1.2 Warranty
We certify that this instrument is guaranteed to be free from defects in
material and workmanship
for two years against faulty components and
assembly.
This warranty does not include routine cleaning and preventive
maintenance to be performed according to instructions in
section 9.1 (Preventive and Scheduled Maintenance).
Tuttnauer warrantees all new autoclaves for a period of two full years,
covering both parts and labor. This two year warranty covers defects in
materials and workmanship on every part in the autoclave except door
gaskets and HEPA filters (they are 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 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!
1.3 Warranty Statement
To activate the warranty, the registration card must be completed and
returned to Tuttnauer within fourteen (14) days of purchase or you may call
our customer service department at the number listed below.
No product will be received or accepted for repair without prior return
authorization from Tuttnauer. All transportation charges to and from
Tuttnauer must be paid by the owner of the autoclave. During the first 90
days after purchase of an autoclave, Tuttnauer will pay shipping costs on
an individually evaluated basis and ONLY with pre-approval.
5
Note:
If y
ou have any questions or there are any difficulties with this instrument
and the solution is not covered in this manual, please contact your dealer or
Tuttnauer USA Co. Do not attempt to service this instrument yourself.
6
2 TECHNICAL DATA
2.1 Introduction
This tabletop autoclave is designed for the 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 ensuring a fully automatic
sterilization cycle, control and monitoring of physical parameters and a
clear documentation of the sterilization cycle controls the autoclave.
The autoclave has three automatic programs, according to the material to
be sterilized, and one auxiliary drying program. Models EA and EKA are
equipped with an air compressor that, during the drying stage, draws air
through a HEPA filter (0.2µm). It pushes that air through the heated
chamber to remove moisture and facilitate the dry
ing operation. Drying is
performed with the door closed.
On all models (except 1730), 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
regular operation of the pump.
The control system provides adequate protection to ensure the safety of
personnel and reliable operation with a minimum of shutdown time.
On all models (except 1730), a printer is an optional addition to the
autoclave. The printer prints the preset and actual parameters of the cycle
(temperature, time and pressure).
This manual is intended for the user and gives the user a general
understanding of the instrument and the best ways to operate and take
care of it in order to obtain optimum effective results.
After reading this manual, operating the autoclave will be easy. However,
since this instrument is built with high technology sensitive components,
no attempt should be made by the user or any other unauthorized person
to repair or recalibrate it.
Only technical personnel, having proper qualifications and holding
technical documentation (including a technician manual) and
adequate information are authorized to service the apparatus.
2.2 Standby Heating Mode
The autoclave provides an option of heating the chamber in standby
mode between cycles with a very low power in order to reduce total cycle
time (1.6% of the total power only). The autoclave turns off automatically
if the interval between the sterilization cycles is more than 2 hours. This
feature is standard on all EK, EKA models and optional on all E, EA
models.
2.3 Environmental Emission Information
1. The peak sound level generated by the autoclave is less than 70 dBA
with background noise of 60 dBA.
2. The total heat per hour transmitted by the autoclave is < 100 Wh for all
models.
7
2.4 Operating Conditions
This device is to be used for indoor use.
This autoclave is intended for NORMAL environment conditions as
follows:
Altitude up to 2000m.
Room temperature range 41ºF to 104ºF (5ºC to 40ºC).
Installation Category II.
Pollution Degree 2.
Maximum relative humidity 80% for temperature up to 31ºC decreasing
linearly to 50% relative humidity at 40ºC.
Main supply voltagefluctuations up to +/-5% of the nominal voltage.
The sterilizer should be loaded only with autoclavable material.
Caution!
Waste water
should be brought into the public net in accordance
with the local rules or requirements, i.e.
ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN
PUBLIC SEWAGE!
2.5 Utilities
Utilities Unit Value
V-A 1ph, 120V – 16A,50/60 Hz
Power supply (as appropriate)
V-A 1ph, 230V – 16A,50/60 Hz
Attention:
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.
2.6 Construction
The main parts of the autoclave are made of materials as indicated below:
Chamber is electro-polish and built of stainless steel 316 L.
Door is made of stainless steel CF8.
Trays are made of stainless steel 316.
Water reservoir is made of hard plastic material.
Door handle is made of hard plastic material, which is safe to touch and
thermo-insulated.
Covers are made of aluminum sheet, coated with Epoxy paint.
2.7 Symbol Description
Caution! Consult accompanying documents.
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground).
Standby
8
2.8 Electrical Data
1730 2340 2540 3140 3850 3870
E EK
E,
EA
EK,
EKAE,EA
EK,
EKAE, EAE, EAE, EA
Ampere (A)
at 230/240V
4.6 5.9 6 9.6 6 9.6 10.4 10.4 13
Ampere (A)
at 120V
8.8 11.2 11.7
11.7
20.0
Watts (W) 1050 1350 1400 2200 1400 2200 2400 2400 3000
Frequency 50 / 60 Hz
Degree of protection by enclosure IP31
AUTOCLAVE TYPE
E EA EK EKA
DESCRIPTION
120V 230V 120V 230V 120V 230V 120V 230V
1730
Circuit breaker (A) 15 10
15 10
Air pump fuse (A)
Water pump fuse (A)
2340 / 2540
Circuit breaker (A) 15 10 15 10
15
15
Air pump fuse (A)
2.0 1.25
1.25
Water pump fuse (A) 1.25 1.25 1.25 1.25
1.25
1.25
3140 / 3850 / 3870
Circuit breaker (A)
15
15
Air pump fuse (A)
1.25
Water pump fuse (A)
1.25
1.25
For autoclaves
Models EA, EKA
(with an air pump)
For autoclaves
Models E, EK
(without an air pump)
9
2.9 Specifications
Overall Dimensions
1730 2340 2540 3140 3850 3870
Model
Dimensions
mm in mm in mm in mm in mm in mm in
A 440 17.4 510 20.0 510 20.0 590 23.2 660 26.0 660 26.0
B 305 12.0 365 14.4 365 14.4 450 17.7 525 20.7 525 20.7
Overall
Dimensions
C 455 17.9 540 21.5 545 21.5 566 21.9 695 27.5 875 34.5
D 750 29.5 910 35.8 910 35.8 990 39.0 1155 45.5 1335 53.0
Maximum
Dimensions
(door open)
E 560 22.0 630 24.8 655 25.8 755 29.7 815 32.0 815 32.0
F 234 9.2 299 11.8 299 11.8 371 14.6 451 17.8 451 17.8
F1 339 13.4 422 16.6 422 16.6 488 19.2 562 22.1 562 22.1
G 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0
Distance
Between
Supporting Legs
H 315 12.4 400 15.8 400 15.8 400 15.2 555 2.0 725 2.0
Reservoir Volume
3
lit.
0.8
gal.3 lit.
0.8
gal.3 lit.
0.8
gal.
3.0
lit.
0.8
gal.6 lit.
1.6
gal.6 lit.
1.6
gal.
Minimum Water
Vol. in Reservoir
0.8
lit.
0.21
gal.
0.8
lit.
0.21
gal.
0.8
lit.
0.21
gal.
0.8
lit.
0.21
gal.
2.0
lit.
0.53
gal.
2.0
lit.
0.53
gal.
Max. Allowable
Working Pressure
(MAWP)
2.76 bar (40 psi)
Load No. Counter Counting from 0 to 250 and nullifies.
10
Shipping
Volume
0.18 m
3
(6.35 cu.f.)
0.27m
3
(9.4 cu.f.)
0.27m
3
(9.4 cu. f.)
0.35 m
3
(12.4 cu.f)
0.63 m
3
(22.2cu.f.)
0.76m
3
(26.8cu.f)
Shipping
Weight
25 kgs.
(55 lbs.)
36 kgs.
(79 lbs.)
48 kgs.
(106 lbs.)
60 kgs
(132 lbs.)
89 kgs.
(196 lbs.)
102 kgs.
(225 lbs.)
Full
2
3
4
10
15
No. of
Standard
Cassettes
(Optional)
Half
2
2
3
4
Printer
(Optional)
No
Yes
Yes
Yes
Yes
Yes
No. of Trays
3
3
4
2
2
2
Tray Dimensions
W X D X H
12 x 29.5 x 2 cm
(4.7" x 11.6" x 0.8")
17 x 41.5 x 2cm
(6.7" x 16.3" x 0.8")
17 x 41.5 x 2 cm
(6.7" x 16.3" x0.8")
25.6 x 40.8 x 2.5 cm
(10.1” x 16.1” x 1”)
19.8 x 40.8 x 2.2 cm
(7.8” x 16.1” x 1”)
28 x 50 x 2.5 cm
(11" x 20 " x 1" )
35 x 50 x 2.5cm
(14" x 20 " x 1")
28 x 67 x 2.5cm
(11" x 26" x 1")
35 x 67 x 2.5
(14" x 26" x 1")
Volume of
Mineral Free
Water
Reservoir
3.0 liters.
(0.66 US gal.)
3.0 liters.
(0.66 US gal.)
3.0 liters.
(0.66 US gal.)
3.0 liters.
(0.66 US gal.)
7.5 liters.
(2.0 US gal.)
7.5 liters.
(2.0 US gal.)
Volume of
Chamber
7.5 liters.
(2 US gal.)
19 liters.
(5 US gal.)
23 liters.
(6 US gal.)
34.4 liters
(7.8 US gal.)
65 liters.
(17 US gal)
84 liters.
(22 US gal.)
Chamber
Dimensions
DIA x D
17 x 34 cm
(7" x 13")
23 x 47 cm
(9" x 18")
25.4 x 47.5cm
(10" x 19")
31 x 39.1
(12” x 15”)
38 × 58 cm.
(15" × 23" )
38x76 cm
(15" x 30")
2.10 Technical Specifications
Model
1730
2340
2540
3140
3850
3870
11
2.11 Directives and Standards
The autoclaves are FDA cleared and comply with the following
Standards:
2.11.1 Technical Standards
1. A.S.M.E. Code, Section VIII div.1 for unfired pressure vessels.
2. AAMI/ANSI ST-55:2001 Tabletop steam sterilizers.
3. UL61010-1 Safety for Electrical Equipment for Measurement,
Control, and Laboratory Use, General Requirements.
4. UL61010-2-041 Particular Safety for Autoclaves.
2.11.2 Quality Standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2000:2008– Quality System.
2. ISO 13485:2003 – Quality systems – Medical devices –
Particular requirements for the application of ISO 9001.
12
2.12 Water Quality
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 acceptable contaminants levels in water,
for sterilizers
Element Condensate – allowable content
Silicium oxide. SiO
2
≤0.1 mg/kg
Iron ≤0.1 mg/kg
Cadmium ≤0.005 mg/kg
Lead ≤ 0.05 mg/kg
Rest of metals except iron,
cadmium, lead
≤0.1 mg/kg
Chloride (Cl) ≤0.1 mg/kg
Phosphate (P2O5) ≤0.1 mg/kg
Conductivity (at 20°C) ≤3 μs/cm
pH value (degree of acidity) 5 to 7
Appearance Colourless clean without sediment
Hardness (Σ Ions of alkaline
earth)
≤0.02 mmol/l
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 does not comply with the table
above may have severe impact on the working life of the sterilizer and
can invalidate the manufacturer’s guarantee.
13
FRONT VIEW
No.
Description
1 Reservoir water drain valve
2 Ring for drain valve
3 Door closing device
4 Door switch
5 Autoclave cover
6 Water reservoir cover
7 Water reservoir – assembly
8 Safety valve
9 Air relief valve
10 Pressure gauge
11 Validation port cover
12 Main switch
13 Printer
14 Front panel key board
15 Completion to panel
16 Panel base
17 RS232 port cover
Model 1730
Models 2340/2540
Models 3140/3850/3870
Old (gray) control panel
New (blue) control panel
14
REAR VIEW
EA,EKA
only
Cut-Out Thermostat
Reset button
15
3 KEYBOARD (Keys and Display)
FRONT PANEL KEYBOARD – OLD TYPE (GRAY)
Note: See section 3.2 for a description of the Keyboard buttons
16
FRONT PANEL KEYBOARD – NEW TYPE (BLUE)
Note: See section 3.2 for a description of the Keyboard buttons
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