Tuttnauer E-Series User and maintenance manual (Rev.E)
OPERATION
&
MAINTENANCE
MANUAL
E-Type Electronic Table -Top Autoclaves
models 1730, 2340, 2540, 3140, 3850,3870
E, EK, EA & EKA
Cat. No. MAN205-0001 Rev. E
Tuttnauer Europe b.v., P.O. Box 7191, 4800GD Breda, The Netherlands. + 31/76-5423510
Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA (800) 624 5836, (631) 737 4850, Fax: (631) 737 07 20
Email: info@tuttnauer.com
TABLE OF CONTENTS
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 Stand – by heating mode..........................................................................6
2.3 Operating Conditions...............................................................................7
2.4 Utilities......................................................................................................7
2.5 Environment Emission Information .......................................................7
2.6 Electrical Data: ........................................................................................ 7
2.7 Specifications ........................................................................................... 8
2.8 Technical Specifications (for E, EK, EA, EKA models) ........................9
2.9 Construction ........................................................................................... 10
2.10 Directives and Standards ....................................................................... 10
2.11 Water quality .......................................................................................... 11
2.12 Symbol Description ................................................................................ 12
3 STERILIZATION PROGRAMS ........................................................................ 15
3.1 Program 1 (134ºC with no drying) .......................................................15
3.2 Program 2 (121ºC with no drying) .......................................................16
3.3 Program 3 (134ºC with drying) ............................................................17
3.4 Program 4 (121ºC with drying) ............................................................18
3.5 Program 5 (121ºC with slow exhaust)..................................................19
4 KEYBOARD (keys and display) .........................................................................20
4.1 Description and Functions of the Front Panel Keyboard.................... 21
4.2 Description of the Operational Messages .............................................24
4.3 Description of Displayed Error Messages and Safety Measures ......... 26
5 PRINTER ............................................................................................................ 28
5.1 Printer Operation ...................................................................................28
5.2 Printer Handling.................................................................................... 30
6 INSTALLATION PLACING AND LEVELING INSTRUCTIONS .................31
6.1 leveling.................................................................................................... 31
6.2 Water quantity for a cycle......................................................................32
6.3 Lifting and carrying............................................................................... 32
6.4 Loading and unloading the Device .......................................................32
6.5 Filling the Water Reservoir ................................................................... 33
7 PREPARATION BEFORE STERILIZATION .................................................34
8 OPERATING INSTRUCTIONS ........................................................................ 38
1
TABLE OF CONTENTS (Cont.)
PARAGRAPH PAGE NO.
9 MAINTENANCE INSTRUCTIONS..................................................................40
9.1 Preventive and Scheduled Maintenance ...............................................40
9.2 Draining the Reservoir...........................................................................41
9.3 Cleaning Air Jet ..................................................................................... 42
9.4 Replacing the Door Gasket ....................................................................43
9.5 Replacing the Air Filter (models EA, EKA) .........................................44
9.6 Cleaning water outlet strainer ...............................................................45
9.7 Replacing the Cartridge Fuse................................................................46
9.8 Checking the Safety Valve .....................................................................47
9.9 Door Safety System ................................................................................48
9.10 Cleaning Table Top Autoclaves with Chamber Brite™....................... 49
10 TROUBLESHOOTING ..................................................................................51
11 ACSSESORIES LIST ..................................................................................... 57
12 SPARE PARTS LIST......................................................................................57
2
TABLE OF CONTENT (Cont.)
DRAWINGS PAGE NO.
Front View...................................................................................................................13
Rear View ....................................................................................................................14
Front Panel Keyboard................................................................................................. 20
Pouch Rack .................................................................................................................54
Tray..............................................................................................................................55
Tray handle CMT240-0001 ........................................................................................55
Tray holder ..................................................................................................................56
Alternative tray holder ................................................................................................56
3
1 GENERAL
Read the Operating Instructions carefully, before beginning any operation
on the autoclave!
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 paragraph 9.1 (Preventive and Scheduled
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 autoclaves that have been repaired or
altered by an un-authorized person.
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., Paardeweide 36, P.C. Box 7191,
4800GDBreda, Netherlands. +31/76-5423510, Fax: +31/765423540, E-mail: Tuttnauer@tip.nl
Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA
(800) 624 5836, (631) 737 4850, Fax: (631) 737 07 20
Email: info@tuttnauer.com
Rudolf Gunz & Co. PTY LTD:
Service Department, 26-34 Dunning Avenue, Ros, 2018, Sydney,
Australia.
Service Department, Locked bag 690, Beaconsfield, NSW 2014,
Australia.
+61-2-99356600 Fax: +61-2-99356650
4
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 autoclaves will be accepted for repair without proper authorization
from us. All transportation charges must be paid both ways by the
owner. This warranty will be void if the unit is not purchased from an
authorized full service Tuttnauer dealer.
5
2 TECHNICAL DATA
2.1 Introduction
This E-Type table-top autoclave is designed for the sterilization of
medical and surgical solid instruments in dental, medical and
veterinary clinics, first aid rooms, laboratories etc.
Types E and EK are intended to sterilize non wrapped solid products.
Types EA and EKA are intended for sterilization of non-wrapped and
wrapped solid products.
The autoclave models E, EK, EA and EKA are electrically - heated
sterilizers of different dimensions, using steam as the sterilizing agent.
A computerized control unit ensuring a fully automatic sterilization
cycle and precise control and monitoring of physical parameters and a
Five automatic programs are available, according to the material to be
On all models (except 1730), a water pump is installed between the
The control system provides adequate protection, to ensure the safety
All models (except 1730) are equipped with a pressure gauge that is
On all models (except 1730), a printer is an optional addition to the
This manual is intended for the user and gives the user a general
After reading this manual, operating the autoclave will be easy.
Only technical personnel having proper qualifications and holding
2.2 Stand – by heating mode
The autoclave provides an option of heating the chamber in stand-by
clear documentation of the sterilization cycle controls the autoclave.
sterilized. All sizes (except 1730) have a model that includes a drying
stage (EA and EKA). The difference between EK and EKA is the air
compressor that, during the drying stage, pushes filtered air (0.2µm.)
through the chamber to pull out the humidity, the dry operation is
performed with the door closed.
water reservoir and the chamber. This pump intensifies the water flow
into the chamber. Entry of water may be accompanied by a noise for
approximately 30 seconds. This is normal noise generated by regular
operation of the pump.
of personnel and reliable operation with a minimum of shut down time.
used as a 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. The accuracy is ± 1.6%.
autoclave. The printer prints the preset and actual parameters of the
cycle (temperature, time and pressure/vacuum).
understanding of the instrument and the best ways to operate and take
care of it in order to obtain optimum effective results.
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.
technical documentation (including a technician manual) and
adequate information are authorized to service the apparatus.
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. The stand-by feature is activated, as default, on cycles 1,
2, 3, 4 and not activated on cycle 5.
6
The company – qualified technician can cancel this feature on EK or
EKA models, or activate it on E and EA models, according to customer
requirements.
2.3 Operating Conditions
This device is for indoor use only!
The sterilizer should be loaded only with autoclavable material!
The environment shall not exceed an ambient temperature of 40ºC and
a relative humidity of 85% respectively.
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!
2.4 Utilities
Utility Unit Value
Power supply (as appropriate)
V-A 1ph, 230/240V – 16A, 50 Hz
V-A 1ph, 120V – 16A, 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.
2.5 Environment 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.
2.6 Electrical Data:
1730 2340 2540 3140 3850 3870
E EK E, EA
Ampere (A)
at 230/240V
Ampere (A)
at 120V
Watts (W) 1050 1350 1400 2200 1400 2200 2400 2400 3000
4.6 5.9 6 9.6 6 9.6 10.4 10.4 13
8.8 11.2 11.7
EK,
EKA
E, EA
11.7
EK,
EKA
E, EA E, EA E, EA
20.0
Frequency 50 / 60 Hz
Protection against electrical shock Class I (IEC 60601-1)
7
2.7 Specifications
Overall Dimensions
Model
1730 2340 2540 3140 3850 3870
Dimensions
Overall
Dimensions
Maximum
mm in mm in mm in mm in mm in mm in
A 440 17.4 510 20.0 510 20.0 590
B 305 12.0 365 14.4 365 14.4 450
C 455 17.9 545 21.5 545 21.5 566
D 750 29.5 900 35.8 900 35.8 990
23.2
17.7
21.9
660 26.0 660 26.0
525 20.7 525 20.7
695 27.5 875 34.5
39.0
1155 45.5 1335 53.0
dimensions
(door open)
E 560 22.0 655 25.8 655 25.8 755
29.7
815 32.0 815 32.0
F 350 13.8 415 16.4 415 16.4 488 19.2 450 2.0 450 2.0
Distance between
supporting legs
F1 - front legs
F - rear legs
F1 339 13.4 422 16.6 422 16.6 371 14.6 564 22.2 564 22.2
G 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0
H 315 12.4 400 15.8 400 15.8 400 15.8 555 2.0 725 2.0
Chamber diameter 170 6.7 230 9.1 254 10.0 312 12.3 384 15.1 384 15.1
Depth 340 13.4 470 18.5 475 18.7 475 15.4 580 22.8 760 29.9
3.0
0.8
3.0
0.8
3.0
0.8
3.0
0.8
6.0
1.6
6.0
Reservoir volume
Minimum water
vol. in Reservoir
Max. Allowable
Working Pressure
(MAWP)
lit.
0.8
lit.
gal
0.21
gal
lit.
0.8
lit.
gal
0.21
gal
lit.
gal
0.8
0.21
lit.
gal
2.76 bar (40 psi)
lit.
0.8
lit.
gal
0.21
gal
lit.
2.0
lit.
gal
0.53
gal
lit.
2.0
lit.
1.6
gal
0.53
gal
Load No. counter Counting from 0 to 3000 and nullifies.
8
3
Volume
Shipping
Weight
Shipping
0.18 m
25 kgs.
Printer
Full
No. of standard
Cassettes (Optional)
Half
No.
of trays
0.27m3
(6.35 cu.f.)
36 kgs.
(55 lbs.)
N/A
—
2
3
(9.4 cu.f.)
(79 lbs.)
Yes
2
2
3
0.27m3
(9.4 cu. f.)
48 kgs.
(106 lbs.)
Yes
3
3
4
0.35 m3
(12.4cu.f.)
60 kgs.
(132 lbs.)
Yes
4
4
2
0.63 m3
(22.2cu.f.)
89 kgs.
(196 lbs.)
Yes
—
10
2
0.76m3
(26.8cu.f)
102 kgs.
(225 lbs.)
Yes
—
15
2
35 x 67 x 2.5
28 x 67 x 2.5cm
( 11" x 26" x 1" )
(14" x 26" x 1")
W X D X H
Tray dimensions
12 x 29.5 x 2 cm
(4.7" x 11.6" x 0.8")
17 x 41.5 x 2cm
17 x 41.5 x 2 cm
(6.7" x 16.3" x 0.8")
(6.7" x 16.3" x0.8")
(10.1 x 16.1 x 1)
25.6 x 40.8 x 2.5
(7.8 x 16.1 x 1)
19.8 x 40.8 x 2.2
35 x 50 x 2.5cm
28 x 50 x 2.5 cm
(11" x 20 " x 1" )
(14" x 20 " x 1")
space
usable
Volume of
7.5 liters
(2 US gal.)
19 liters
23 l.
(5 US gal.)
(6 US gal.)
34.4 liters
(7.8 US gal.)
65 liters
(17US gal)
84 liters
(22 US gal)
DIA x D
Chamber
dimensions
17 x 34 cm
23 x 47 cm
(6.7" x 13.4")
(9" x 18.5")
(10" x 18.7")
25.4 x 47.5cm
31.2 x 39.1
(2.3” x 15.4”)
38 × 58 cm.
(15" × 23" )
38x76 cm
(15" x 30")
2.8 Technical Specifications (for E, EK, EA, EKA models)
Models
1730
2340
2540
3140
3850
3870
9
2.9 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.
2.10 Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
2.10.1 Technical Directives
1. Medical device directive MDD/93/42/EEC.
2.10.2 Technical Standards
1. A.S.M.E. Code, section VIII division 1 for pressure
vessels.
2. EN 61010-1:93 – Safety of electrical equipment
…General requirement.
3. EN 61010-2-041:97 – Particular requirement for steam
autoclaves.
4. EN 50081-1:92 – (EMC) Emission compatibility…
5. EN 50082-1:97 – (EMC) Immunity compatibility….
6. prEN 13060-1:97-General requirements for all types of
small steam sterilizers.
7. prEN 13060-3 and 4:97-Particular requirements and
test method for type N and S sterilizers.
2.10.3 Quality standards
The manufacturing plant meets the following quality
standards:
1. EN ISO 9002 (7.94) – Quality System
2. EN 46002 (8.96) - Quality System - Medical device Particular requirements.
3. ISO 13488 – Quality systems – Medical devices –
Particular requirements for the application of ISO
9002.
The manufacturer retains all supporting documentation.
10
2.11 Water quality
2.11.1 Water for generation of steam
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
Evaporate residue
levels in water, for sterlizers
< 15 mg/l
Silica
Iron
Cadmium
Lead
Rest of heavy metals
Chloride
Phosphate
Conductivity
< 2 mg/l
< 0.2mg/l
< 0.005 mg/l
< 0.05 mg/l
< 0.1 mg/l
< 3 mg/l
< 0.5 mg/l
< 50 µs/cm
pH 6.5 to 8
Appearance colourless, clean, without sediment
Hardness
< 0.1 mmol/l
Compliance with the above data should be tested in
accordance with acknowledged analytical methods, by an
authorized laboratory.
Attention:
We recommend testing the water quality once a month. 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.
2.11.2 Reverse Osmosis
A Reverse Osmosis (RO) system may be used to improve the
quality of the water used to generate steam in the steam
generator.
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:
11
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.
2.12 Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
Stand by
12
L:\WORD-PLT\man035.doc
Front View
No. Description
Model 1730
Models 2340/2540
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
Flat cable for ANL-T1 – RS232
18
RS232 port cover
2.12.1.1.1.1
Models 3140/3850/38/70
13
Rear View
14
3 STERILIZATION PROGRAMS
The autoclave offers 5 sterilization programs, with or without drying stage.
3.1 PROGRAM 1 (134ºC with no drying)
For unwrapped instruments and materials when the manufacturer
recommends autoclaving at temperatures of 134ºC / 273ºF with no
drying.
Nominal Parameters
♦ Sterilization temperature: 134ºC (273ºF).
♦ Sterilization time: 3 mins.
Operation Sequence
♦ Steam is generated by electric heating elements heating the water
until the sterilization temperature is reached.
♦ Sterilization temperature is maintained constant for the preset
sterilization time.
♦ Fast exhaust; steam is exhausted out of the chamber at a fast rate
until pressure drops to atmospheric pressure.
Ambient Pressure
and Temperature
Attention:
The sterility of instruments processed in unwrapped cycles cannot
be maintained if exposed to non-sterile environment.
TEMPERATURE
PRESSURE (kPa)
t1 t2
= Pressure
= Temperature
t1 = steam generation stage
t2 = Sterilization stage
t3 = Fast exhaust Stage
15
3.2 PROGRAM 2 (121ºC with no drying)
For unwrapped instruments and materials when the manufacturer
recommends autoclaving at temperatures of 121ºC / 250ºF with no
drying.
Nominal parameters
♦ Sterilization temperature: 121ºC (250ºF).
♦ Sterilization time: 15 mins.
Operation Sequence
♦ Steam is generated by electric heating elements heating the water
until the sterilization temperature is reached.
♦ Sterilization temperature is maintained constant for the preset
sterilization time.
♦ Fast exhaust; steam is exhausted out of the chamber at a fast rate
until pressure drops to atmospheric pressure.
Attention:
Ambient Pressure
and Temperature
TEMPERATURE
PRESSURE (kPa)
The sterility of instruments processed in unwrapped cycles
cannot be maintained if exposed to non-sterile environment.
t1 t2
= Pressure
= Temperature
t1 = Steam generation stage
t2 = Sterilization stage
t3 = Fast exhaust Stage
16
t3
3.3 PROGRAM 3 (134ºC with drying)
For unwrapped instruments, paper packed instruments and other
materials when the manufacturer recommends autoclaving at
temperatures of 134ºC/ 273ºF with drying stage.
Nominal parameters
♦ Sterilization temperature: 134ºC (273ºF).
♦ Sterilization time: 12 mins.
♦ Dry time: 30mins.
Operations Sequence
♦ Steam is generated by electric heating elements heating the water
until the sterilization temperature is reached.
♦ Sterilization temperature is maintained constant for the preset
sterilization time.
♦ Fast exhaust; steam is exhausted out of the chamber at a fast rate
until pressure drops to atmospheric pressure.
♦ Drying; heating of chamber for 30 min. at a reduced power.
Venting the chamber with a pump (on EA, EKA model).
Notes:
1. On E, EK models the door shall be opened to reduce drying time.
2. On EA, EKA models the drying stage is performed with a closed
door. Filtered air is pumped into the chamber to ventilate the
chamber during the drying stage.
3. 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 be easily be
removed, and will not have any effect on the steriliszed goods.
Attention
:
The sterility of instruments processed in unwrapped cycles
cannot be maintained if exposed to non-sterile environment.
TEMPERATURE
PRESSURE (kPa)
Ambient Pressure
and Temperature
= Pressure
= Temperature
t1 t2
t1 = Steam generation stage
t2 = Sterilization stage
t3 = Fast exhaust Stage
TIME
17
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