Tuttnauer ELARA9-D, ELARA11-D Operation & Maintenance Manual
OPERATI ON
&
MAI NTENANCE
MANUAL
Pre-vacuum Steam Sterilizer with
Generator
Models ELARA9-D, ELARA11-D
Cat. No. MAN205-0497001ENRev A
Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda, P.O. Box 7191, 4800 GD Breda,
Netherlands.
+31/76-5423510, Fax: +31/76-5423540
Page 1
TABLE OF CONTENTS
PARAGRAPH PAGE NO.
1. GENERAL...................................................................................................................................3
1.1. INTRODUCTION ................................................................................................ ..........................3
1.2. INCOMING INSPECTION................................................................................................................ 3
1.3. WARRANTY DESCRIPTION.............................................................................................................4
1.4. WARRANTY STATEMENT .............................................................................................................. 4
1.5. SAFETY .....................................................................................................................................4
1.6. SPECIFICATIONS................................................................ .......................................................... 5
1.7. GENERATOR STEAM DATA............................................................................................................ 9
1.8. AUTOCLAVE ELECTRICAL DATA ...................................................................................................... 9
1.9. UTILITIES .................................................................................................................................. 9
1.10. ENVIRONMENTAL EMISSION INFORMATION ................................................................................... 10
1.11. CONSTRUCTION........................................................................................................................10
1.12. STICKERS DESCRIPTION .............................................................................................................. 10
1.13. WATER QUALITY ...................................................................................................................... 10
1.14. DIRECTIVES AND STANDARDS................................ ...................................................................... 11
2. CONTROL PANEL ..................................................................................................................... 12
2.1. KEYPAD ..................................................................................................................................13
2.2. PRINTER ................................................................................................................................. 14
2.3. PRINTER HANDLING .................................................................................................................. 14
2.4. DISPLAYED ERROR MESSAGES / SYMBOLS ..................................................................................... 16
2.5. DISPLAYED OPERATIONAL MESSAGES / SYMBOLS............................................................................16
3. STERILIZATION PROGRAMS ..................................................................................................... 17
3.1. STERILIZATION CYCLE DESCRIPTION .............................................................................................. 17
3.2. VACUUM TEST PROCESS DESCRIPTION.......................................................................................... 18
3.3. BOWIE AND DICK TEST PROCESS DESCRIPTION ............................................................................... 18
4. INSTALLATION INSTRUCTION .................................................................................................. 18
4.1. LIFTING AND CARRYING ................................................................ ............................................. 18
4.2. INSTALLATION PREPARATIONS..................................................................................................... 19
5. PREPARATION BEFORE STERILIZATION. LOADI NG .................................................................. 20
5.1. GENERAL RULES TO BE CONSIDERED:............................................................................................20
6. OPERATING INSTRUCTIONS..................................................................................................... 23
6.1. FILLING THE MINERAL-FREE WATER RESERVOIR. ............................................................................ 23
6.2. TURNING ON THE AUTOCLAVE.....................................................................................................24
6.3. WASTE WATER LEVEL ............................................................................................................... 24
6.4. HEATING................................................................................................ ................................. 24
6.5. OPENING THE DOOR ................................................................................................ .................24
6.6. STARTING A CYCLE .................................................................................................................... 25
6.7. ENDING THE CYCLE. UNLOADING................................................................ ................................. 25
6.8. STOPPING THE PROCESS MANUALLY................................................................ ..............................26
6.9. STOPPING THE PROCESS DUE TO CYCLE FAILURE.............................................................................. 26
7. CHECKING AND CHANGING PARAMETERS AND OTH ER DATA ................................................. 26
7.1. QUICK OPTIONS SCREEN ............................................................................................................ 26
7.2. ENTERING THE MAIN MENU....................................................................................................... 27
7.3. SYSTEM PARAMETERS................................................................................................................ 27
7.4. MAINTENANCE ........................................................................................................................ 27
8. MAINTENANCE INSTRUCTIONS ...............................................................................................28
8.1. PREVENTIVE AND SCHEDULED MAINTENANCE ................................................................................ 28
8.2. CLEAN THE OUTER PARTS OF THE AUTOCLAVE WITH A SOFT CLOTH. ..................................................... 28
Page 2
8.3. DRAINING THE RESERVOIR................................................................ .......................................... 29
8.4. CLEANING THE WATER OUTLET STRAINER....................................................................................... 30
8.5. REPLACING THE HEPA AIR FILTER ............................................................................................... 30
9. TROUBLESHOOTING ................................................................................................................ 31
10. SPARE PARTS LIST ................................................................................................................... 34
11. ACCESSORIES........................................................................................................................... 34
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1. GENERAL
1.1. Introduction
The ELARA autoclave is designed for sterilization of wrapped and unwrapped instruments,
and related items found in dental, medical, and veterinary clinics, first aid rooms, hospitals,
laboratories etc. The autoclave offers a choice of automatic programs designed to match the
material to be sterilized. Drying is performed with the door closed.
This autoclave model is a steam-heated sterilizer using steam as a sterilizing agent. A
computerized control unit ensures a fully automatic sterilization cycle, control and monitoring
of physical parameters and a clear documentation of the sterilization cycle.
This autoclave is equipped with a vacuum system. The advantages of the prevacuum
sterilizer in comparison to the regular gravity displacement steam sterilizer are as follows:
• Removal of air pockets from packs and porous load 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.
• A post sterilization drying phase based on the combined operation of heat and
vacuum with air inlet pulses.
A digital display is used for monitoring and control purposes. The device is capable of
displaying the pressure in psia, psig, or in kPa according to the operator’s requirements.
When the pressure is displayed in psig, the atmospheric pressure is shown (at sea level) as 0
psig. If the pressure is defined in psia or kPa the absolute zero is displayed as “0” and the
atmospheric pressure is shown (at sea level) as 14.7 psia or 100 kPa respectively. The Elara
can display temperature in ºF or ºC.
A printer is a standard addition to the autoclave. The printer prints the preset and actual
parameters of the cycle (temperature, time and pressure).
The ELARA9-D/ELARA11-D features built in memory to record up to 100 sterilization cycles.
These can be reprinted on the printer or exported to a USB device to be transferred to a PC.
The ELARA9-D/ELARA11-D has a built in Network Port for use with Tuttnauer’s R.PC.R
software when connected to your local network.
The autoclave is available in following configurations:
• Standard (U): Waste water goes to the waste water reservoir. Excess of waste water
is drained through the hole in the bottom of the autoclave.
• W: Waste water is piped directly into the drain.
• WW: Direct inlet of demineralized water from plumbing. A sensor detects lack of water
in the reservoir to open the direct inlet valve.
Read the Operating Instructions carefully, before beginning any operation on the
autoclave!
1.2. 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 they can file a
claim with 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.
Caution!
Lifting and carrying should always be done by two people.
Page 4
1.3. Warranty Description
This warranty does not include routine cleaning and preventive maintenance, to be
performed according to instructions in section 8.1
Tuttnauer warrantees all new ELARA9-D/ELARA11-D autoclaves to be free from defects in
material and workmanship for a period of one full year, covering the parts (except door
gaskets and HEPA filters – they are considered 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!
1.4. 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 European Representative’s Technical Service Department can be reached at:
Tuttnauer Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda, The
Netherlands
Tel: 31 (0) 765423510, Fax: 31 (0) 765423540, Email: info@tuttnauer.nl
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.
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.
1.5. Safety
Never use the autoclave to sterilize corrosive products (acids, bases, or phenols) volatile
compounds or solutions (ethanol, methano,l or chloroform), or radioactive substances.
Safety features
The pressure vessel chamber door has the following features protecting personnel from
hazards:
• Two door switches that indicate that the door is closed and locked. Without this
indication steam is not introduced into the chamber.
• An electrical door locking pin that blocks door opening during operation.
There are the following safety devices installed in the autoclave to optimize its safe operation:
• Two safety thermostats, to prevent over-heating of the steam generator and the
chamber.
• Two safety pressure valves to prevent over-pressurizing the steam generator or the
chamber.
Safety Instructions
• All new autoclave users must receive must undergo a period of training in proper
usage under an experienced employee.
• Before use, check inside the autoclave chamber to ensure that no items have been
left from the previous cycle.
• Load trays in such a way as to allow steam to move freely among all items.
• 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.
Page 5
• On closing the device door, make sure it is properly locked before activating. Verify
that DOOR OPEN
symbol is replaced by the message "System Ready".
• Verify once again that you have chosen the appropriate sterilization program.
• Open the door slowly to allow steam to escape and wait 1 minute before you remove
the load.
• When removing the trays it is recommended to use the tray handle or wear heat
resistant gloves.
• A certified inspector must perform a periodic pressure chamber safety test according
to the local regulations.
• Once a year, or more frequently, effectiveness tests must be performed, i.e.,
calibration and validation.
• Make sure there are no leaks, breaks, blockages, whistles or strange noises.
• Perform maintenance operations as instructed. The owner of the autoclave is
responsible to perform the maintenance operations.
• Notify the person in charge immediately of any deviation from the normal functioning
of the device.
• Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or rules!
1.6. Specifications
Overall Dimensions: ELARA 9-D
Page 6
Overall Dimensions: ELARA 11-D
Page 7
Front View
No.
Description
No.
Description
1
Door switches
8
Ventilation grill
2
Autoclave door
9
On/ off switch / circuit breaker
3
Autoclave cover
10
Keypad
4
Mineral-free water reservoir cover
11
Printer cover
5
Chamber and steam generator safety valves
12
Autoclave Leg
6
Waste water reservoir cover
13
USB connection
7
Display
14
Printer
54689
10
11
121237
14
13
Page 8
Rear View
No.
Description
No.
Description
1
Mineral-free water reservoir cover
7
Automatic water filling inlet (optional)
2
Waste water reservoir cover
8
RJ45 network connector
3
Ventilation grills
9
Chamber cut-off
4
Air filter service cover
10
Chamber cut-off
5
Opening for calibration
11
Main power electric cable socket
6
Overflow outlet to drain
54812
3
6
7
9
10
11
Page 9
Property
ELARA9-D
ELARA11-D
Chamber Diameter
230 mm
280 mm
Chamber Depth
504 mm
504 mm
Chamber volume
19 lit
28 lit. (7.4 gal)
Max. Allowable Working Pressure (MAWP)
2.8 bar
Maximum load per item
0.3kg
0.3kg
Maximum load per tray
1.5
1.5kg
Maximum solid load
5.0kg
8.0kg
Maximum textile load
1.5kg
2.0kg
Tray dimensions
17 x 41.5 x 2.1
cm
17 x 41.5 x 2.1
cm
No. of trays
3
5
Weight
62.15
71.7kg
Mineral-free water reservoir
Max. water
volume
6.6lit
Min. water
volume
2.6lit.
Used (waste) water reservoir
Max. water
volume
5.2lit.
1.7. Generator Steam Data
Property
Value
Max. working pressure
3 BarG
Safety relief valve
5 Bar
1.8. Autoclave Electrical Data
Property
Value
Total Power
2500W
Voltage
1 ph / 230 VAC
Amperage
11A
Protection against electrical shock
Class I (IEC 60601-1)
Mains supply fluctuation
+/- 10%
Frequency (Hz)
50Hz
1.9. Utilities
Property
Value
Mineral free water
See table in 1.13
Power supply
* 1 phase, /230VAC ±10%, 50Hz
Recommended circuit
breaker
16A
* According to the local network.
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