Tuttnauer Elara11 User and maintenance manual (Rev.Q)
(CAT Controller)
OPERATION
&
MAINTENANCE
MANUAL
Pre/Post-vacuum Class B
Table–top Autoclave
Model ELARA 11
Cat. No. MAN205-0342001EN Rev Q
Manufactured by: Tuttnauer Co. Ltd., Har Tuv Industrial zone B P.O.Box 170, Beit Shemesh 99000, IsraelTel: 972 2 9904611,
Fax: 972 2 9904730
Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA. Tel (631) 737 4850, (800) 624 5836, Fax: (631)
737 0720
TABLE OF CONTENT
1. GENERAL ................................................................................................................ 4
1.1. INCOMING INSPECTION ........................................................................... 4
1.2. WARRANTY .............................................................................................. 4
1.3. WARRANTY STATEMENT ......................................................................... 5
2. SAFETY INSTRUCTIONS .................................................................................... 6
3. INSTALLATION ..................................................................................................... 7
3.1. PLACING ................................................................................................... 7
4. GENERAL INFORMATION ............................................................................... 10
4.1. INTENDED USE ....................................................................................... 10
4.2. INTRODUCTION ...................................................................................... 10
4.3. OPERATING CONDITIONS ...................................................................... 11
4.4. SPECIFICATIONS .................................................................................... 12
4.5. UTILITIES ............................................................................................... 13
4.6. ENVIRONMENT EMISSION INFORMATION ............................................. 13
4.7. ELECTRICAL DATA ................................................................................ 13
4.8. CONSTRUCTION ..................................................................................... 14
4.9. SYMBOL DESCRIPTION .......................................................................... 14
4.10. WATER QUALITY ................................................................................... 15
4.11. DIRECTIVES AND STANDARDS ............................................................... 16
5. KEYBOARD .......................................................................................................... 19
5.1. DESCRIPTION AND FUNCTIONS OF THE FRONT PANEL KEYBOARD ..... 20
5.2. DISPLAYED ERROR AND OPERATIONAL MESSAGES ............................. 22
6. STERILIZATION PROGRAMS ......................................................................... 25
6.1. PROGRAM 1: FLASH 134 ........................................................................ 26
6.2. P
6.3. P
ROGRAM 2: WDRY 134 ....................................................................... 27
ROGRAM 3: NODRY 121 ...................................................................... 28
6.4. PROGRAM 4: WDRY 121 ....................................................................... 29
6.5. PROGRAM 5: DELICATE 121 .................................................................. 30
6.6. T
EST 1: B&D TEST ................................................................................ 31
6.7. TEST 2: VACTEST .................................................................................. 32
7. MODIFYING PARAMETERS AND OTHER DATA ....................................... 33
7.1. M
ENU ..................................................................................................... 33
7.2. PARAMETERS ......................................................................................... 34
7.3. SETTING THE CLOCK ............................................................................. 35
7.4. HISTORY ................................................................................................. 36
8. PRINTER ................................................................................................................ 37
8.1. PRINTER OPERATION ............................................................................ 37
8.2. PRINTER HANDLING .............................................................................. 39
9. PREPARATION BEFORE STERILIZATION .................................................. 41
Page 1 of 57
10. OPERATING INSTRUCTIONS .......................................................................... 44
10.1. FILLING THE MINERAL-FREE WATER RESERVOIR.............................. 44
10.2. TURNING ON THE AUTOCLAVE .............................................................. 45
10.3. OPENING THE DOOR ............................................................................... 45
10.4. LOADING ................................................................................................ 45
10.5. CLOSING THE DOOR .............................................................................. 46
10.6. SELECTING A PROGRAM ........................................................................ 46
10.7. UNLOADING ............................................................................................ 46
10.8. STOPPING THE PROCESS ........................................................................ 46
10.9. CANCELING THE ERROR MESSAGE ..................................................... 46
10.10. SLEEP MODE .......................................................................................... 46
11. MAINTENANCE INSTRUCTIONS ................................................................... 47
11.1. PREVENTIVE AND SCHEDULED MAINTENANCE .................................... 47
11.2. D
11.3. R
RAINING THE RESERVOIRS ................................................................. 49
EPLACING THE AIR FILTER ................................................................ 50
11.4. REPLACING THE DOOR GASKET ........................................................... 51
11.5. CHECKING THE SAFETY VALVE ............................................................ 52
11.6. CLEANING WATER STRAINER ................................................................ 53
11.7. EMERGENCY OPENING OF THE DOOR .................................................... 54
12. TROUBLESHOOTING ........................................................................................ 55
13. SPARE PARTS LIST ............................................................................................ 57
14. ACCESSORIES ..................................................................................................... 57
Page 2 of 57
TABLE OF ILLUSTRATIONS
FRONT VIEW ................................................................................................................ 17
REAR VIEW .................................................................................................................. 18
TRAY HANDLE ............................................................................................................. 56
POUCH RACK ............................................................................................................... 56
TRAY ............................................................................................................................ 56
TRAY HOLDER ............................................................................................................. 56
Page 3 of 57
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 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
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
This warranty does not include routine cleaning and preventive
Tuttnauer warrantees all new autoclaves for a period of one full year,
This warranty does not apply to any instrument that has been subjected
Tuttnauer’s obligation is limited to the repair or replacement of parts for
assure safe arrival at their destination.
material and workmanship for one year against faulty components and
assembly.
maintenance which needs to be performed according to instructions
in section 11 (Preventive and Scheduled Maintenance).
covering both parts and labor. This one year warranty covers defects in
materials and workmanship on every part in the autoclave except the
HEPA filter and the door gasket.
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.
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.
Warning
Sterilization programs 1-5 are not considered by the Food and Drug
Administration to be standard sterilization cycles. In the United States,
use only sterilizer accessories that have been cleared by the Food and
Drug Administration for the selected sterilization cycle parameters
(time and temperature). Users should only use sterilizer accessories
(such as sterilization wraps, sterilization pouches, chemical indicators,
biological indicators, and sterilization cassettes) that have been cleared
for use in their markets.
The Autoclave should not be used in a manner not described in this
manual!
Page 4 of 57
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.
Note:
If you 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.
Tuttnauer USA Co., Ltd., 25 Power Drive Hauppauge, NY 11788,
USA
: (800) 624 5836, (631) 737 4850, Fax: (631) 737 0720
e-mail:info@tuttnauerUSA.com.
Page 5 of 57
2. SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand the
operation instructions before first operation of the autoclave. This manual
includes instructions guidance provided by the manufacturer: how to operate
the autoclave, the door safety mechanism, and the hazards involved in
circumventing safety means and how to select an adequate sterilization
program.
Make sure that you know where the main power switch is located.
Autoclave maintenance is crucial for the safe and effective function of the
device.
The daily B&D test, at the beginning of the working day, is part of the
preventive maintenance plan, along with the annual validation of the
sterilization processes that ensures appropriate sterilization conditions.
Never use the autoclave to sterilize liquids since it is not designed for that
purpose.
Below are the operating instructions – safety instructions:
1. 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.
2. Before use, check inside the autoclave chamber to ensure that no items
have been left from the previous cycle.
3. Load trays in such a way as to allow steam to move freely among all items.
4. 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.
5. Individual glass bottles shall be placed on a tray.
6. On closing the device door, make sure it is properly locked before
activating. Verify that DOOR OPEN symbol is replaced by the load
number.
7. Verify once again that you have chosen the appropriate sterilization
program.
8. Open the door slowly to allow steam to escape and wait 1 minute before
you remove the load.
9. When removing the trays it is recommended to use the tray handle or
wear heat resistant gloves.
10. Once a month, ensure that the safety valve is operating.
11. A certified inspector must perform a periodic pressure chamber safety
test according to the local regulations.
12. Once annually, or more frequently, effectiveness tests must be performed,
i.e., calibration and validation.
13. Make sure there are no leaks, breaks, blockages, whistles or strange noises.
14. Perform maintenance operations as instructed. The owner of the
autoclave is responsible to perform the maintenance operations.
15. Notify the person in charge immediately of any deviation from the
normal functioning of the device.
16. Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or
rules!
Page 6 of 57
3. INSTALLATION
3.1. Placing
CAUTION: The installation and all operations described in this
chapter must be done only by an authorized technician.
3.1.1 Lifting and carrying
CAUTION:
Before moving the autoclave, Make sure that the electric
cord is disconnected from the power, and there is no
pressure in the chamber and in the generator.
Attention! The pressure of the generator does not decrease
immediately when the equipment is turned off. Wait
approx. ½ an hour to verify that the pressure has decreased
to atmospheric pressure.
1. Disconnect the power supply cord.
2. Drain the water from both reservoirs.
To avoid injuries, lifting and carrying should be done with at
least two persons or by using a fork-lift or any other mechanical
aid.
Do not drop the device!
3.1.2 Unpacking the autoclave
Unpack the autoclave and inspect 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.
To avoid injuries, lifting and carrying of the autoclave should be
done with at least two persons or by using a fork-lift or any
other mechanical aid.
3.1.3 Installation preparations
1. Check and verify that the counter carrying the autoclave is a
rigid and leveled surface and can carry a load of 225 lbs
(102kg).
Attention:
The Elara11 is not designed for use on any standard slide
out shelf. If it is necessary to use a slide out shelf, it must
be tested and/or rated for 225 lbs or more
2. Check and verify that the counter dimensions are, at least,
22” wide x 24” deep (55cm x 63.5cm).
3. Keep the back and the sides of the autoclave approximately
2” (5 cm) away from the wall to allow ventilation and
facilitate the device disconnection.
4. If placed in a cabinet, verify that the rear of the cabinet is
open to allow ventilation.
Insufficient space for ventilation may result in an increase
of the autoclave's temperature that may cause a malfunction
or damage the instrument.
Page 7 of 57
5. It is recommended that enough space be left around the
autoclave to give a technician access for servicing the
machine.
6. Check and verify that the room ventilation is 10 cycles per
hour minimum.
7. Check and verify that the ambient temperature range is
41°F - 104°F (5ºC-40ºC), it is preferable not to exceed
86°F (30ºC).
8. Check and verify that the ambient relative humidity does
not exceed 85%
3.1.4 Connections to Utility Supplies
1. Check and verify that the power supply is a 1 phase,
230Vac ±5%, 50/60Hz (as appropriate), 15A supply.
2. Check and verify grounding of the autoclave.
3. Check and verify that the electrical net is protected with a
current leakage safety relay.
3.1.5 Final adjustments
Once the autoclave is installed, the following operations have to
be performed before operating any cycle:
1. Setting clock and date (See instruction in the user manual
sec. 7.3).
2. Adjust parameter ATMPressure according to the altitude
of the autoclave (See instruction for adjusting parameters
ATMPressure sec.7.2.6 in the Technicians Manual)
3.1.6 Operating the autoclave
1 Plug the power cord into the power socket.
2 Turn on the Main Switch / Circuit Breaker (see front view).
3 Select "Vacuum Test" cycle to keep the steam generator and
heating elements from heating up. See Selecting a program
sec 10.6.
4 Open the door of the autoclave and remove the trays and the
packaging material.
5 Fill the Mineral Free Water Reservoir with water meeting
the quality specs in section 4.10 as follows:
5.1 Fill with 4 liters of mineral free water by pouring it into
the front reservoir fill opening at the top of the
machine (see front view).”.
5.2 Fill the remaining quantity by pouring water gently,
into the front funnel until it reaches the required level
on the water level sight gauge (See Front View).
6 Insert a paper roll in the printer (see printer handling sec.
8.2).
7 Close the door and perform a Vacuum Test. If the test fails
perform another test since the fail may be a result of
moisture in the air. If the second test fails it may be necessary
to run Program 2 with the long drying cycle to remove any
excess moisture that is causing the test to fail.
Page 8 of 57
8 If the Vacuum Test is successful then select the B&D Test
cycle.
At this stage the chamber and steam generator will be
heating up. It will take approximately 15 minutes (from
selecting the B&D Test).
9 While waiting for the unit to heat up explain and instruct the
operator as follows (use the operation manual as reference):
9.1 Operation principals of the autoclave.
9.2 Preparation for sterilizing instruction including
loading instructions.
9.3 Intended use of each cycle.
9.4 Selecting a cycle.
9.5 Water filling method.
9.6 Displayed error and operational messages.
9.7 Monitoring and changing parameters.
9.8 Printer handling.
9.9 Maintenance instructions
10 Perform a B&D test with a chemical indicator.
11 The operator shall perform a cycle under supervision of the
technician.
Page 9 of 57
4. GENERAL INFORMATION
4.1. Intended Use
This table-top autoclave is designed for sterilization of medical and
surgical goods such as unwrapped and wrapped, solid, hollow, porous
products and tubes in ophthalmic, dental and medical clinics, first aid
rooms, small laboratories etc.
4.2. Introduction
This autoclave model is an electrically heated sterilizer using steam as a
sterilizing agent.
The autoclave is designed as Type B in accordance with EN13060.
This model is a prevacuum sterilizer having the following features;
An air removal stage (prevacuum), before starting the sterilizing stage.
A post-sterilization drying phase, based on the combined operation
of heat and vacuum with air inlet pulses.
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.
A digital display is used for monitoring and control purposes. This
device displays the pressure in kPa, psia or psig, according to the
operators needs. The pressure is displayed for both the pressure in
the chamber and the pressure in the steam generator.
Temperature can be displayed in either °F or °C according to the
operators needs
The advantages of the prevacuum sterilizer are as follows:
Removal of residual air from packs and porous load and most kinds
of tubes (rubber, plastic etc.) by vacuum at the first stage of the
cycle.
More efficient steam penetration into the load; assuring effective
sterilization.
Improved temperature uniformity throughout the chamber.
Better drying of materials due to the vacuum achieved in the
chamber during the drying cycle.
The printer prints the preset and actual parameters of the cycle
(temperature, time and pressure/vacuum).
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 effective results.
Before operating this autoclave read carefully the Operation Manual.
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 install and service the
apparatus.
Page 10 of 57
4.3. Operating Conditions
This device is for indoor use only!
The sterilizer should be loaded only with autoclavable material!
Minimum room ventilation shall be10 cycles per hour
The environment shall not exceed an ambient temperature range of
41ºF-104ºF (5ºC-40ºC) and a relative humidity of 85% respectively.
The operation altitude shall not be over 6500 feet (2000 meters)
(ambient pressure shall not be lower than 80 kPa (11.6 psia)).
CAUTION!
Waste water should be brought into the public net in accordance
with the local rules or requirements
ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN
PUBLIC SEWAGE!
Page 11 of 57
4.4. Specifications
Overall Dimensions
Top View Front View
Property Value
Max. Allowable Working Pressure (MAWP)
Diameter
Chamber
Depth
Chamber volume
Width (A)
Height (B)
External dimensions
Length (C)
Length with
open door (D)
Distance between supporting legs
F - Front legs
F1 - Rear legs
K
F
F1
Maximum load per item
2.8 bar (40 psi)
280 mm (11”)
504 mm (19.8”)
28.5 lit. (7.5 gal)
530 mm (20.8”)
444 mm (17.4”)
645 mm (25.4”)
997 cm (39.25”)
452 mm (17.8”)
315 mm (12.4”)
400 mm (15.7”)
0.5 kg (1.1 lb)
Maximum load per tray
Maximum solid load
Maximum textile load
Tray dimensions
W
H
2.0 kg (4.4 lb)
8.0 kg (17.6 lb)
2.0 kg (4.4 lb)
170 mm (6.7”)
21 mm (0.8”)
No. of trays
Page 12 of 57
L
415 mm (16.3”)
5
Property
Value
Weight
Weight per support area (max. load)
Shipping weight
Width
Height
148 lb (67.1 kg)
1.71 N/m2
(0.036 lb/ft2)
184 lb (83.4 kg)
63 cm (24.8”)
71 cm (28.0”)
Shipping dimensions
Mineral-free water reservoir
Used (waste) water reservoir
Length
Volume
Max. water
volume
Min. water
volume
Max. water
volume
80 cm (35.8”)
0.36 m3 (14.5 ft3)
6.6 lit. (1.74 US gal)
2.6 lit. (0.68 US gal)
5.2 lit. (1.37 US gal)
4.5. Utilities
Utility Value
Mineral free water See table in para 4.10.
Power supply
Recommended circuit breaker 15A
* According to the local network.
Attention:
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.
4.6. Environment Emission Information
1. The peak sound level generated by the autoclave is 65dBa with
background noise of 48 dBa.
2. The total heat per hour transmitted by the autoclave is <200Wh.
4.7. Electrical Data
Property Value
Total Power 2300W
Voltage
Amperage 10A
Protection against electrical shock Class I (IEC 60601-1)
* 1 phase, /230 ±5% Vac,
50/60Hz
1 ph / 230 Vac
Mains supply fluctuation +/- 5%
Note:
In order to avoid any injury by electrical hazard, it is
recommended that a ground fault protection device be installed in
the electrical panel feeding the autoclave (local codes may make
this mandatory).
Page 13 of 57
4.8. Construction
The main parts of the autoclave are made of materials as indicated
below:
Chamber is built of stainless steel 316 L.
Door is made of stainless steel 316.
Trays are made of stainless steel 304.
Water reservoir is made of polyethylene.
Door handle is made of hard plastic material, which is safe to
touch and thermo-insulated.
4.9. Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
Page 14 of 57
4.10. Water Quality
Physical characteristics and contaminants levels
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 Maximum acceptable contaminants
levels in water for sterlizers
(According to ANSI/AAMI ST79:2006).
Element Condensate – allowable content
Evaporate residue ≤15 miligrams/liter (mg/l)
Silica ≤2 mg/l
Iron ≤0.2 mg/l
Cadmium ≤0.005 mg/l
Lead ≤ 0.05 mg/l
Rest of heavy metals ≤0.1 mg/l
Chloride ≤3 mg/l
Phosphate ≤0.5 mg/l
Conductivity ≤50 μs/cm
pH value 6.5 to 8
Appearance Colorless, 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 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.
Page 15 of 57
4.11. Directives and Standards
Every autoclave meets the provisions of the following Directives and is
in compliance with the following Standards:
4.11.1. Technical Standards
1. ANSI/AAMI ST55 – Small Steam Sterilizers.
2. ASME Code, section VIII division 1 for pressure
vessels.
3. UL 61010-1 electrical equipment for laboratory use;
general requirements
4. IEC 61010-2-040 particular requirements for sterilizers
and washer disinfectors used to treat medical materials.
The following standards were taken in consideration:
5. ANSI/AAMI ST79, Comprehensive guide to steam
sterilization and sterility assurance in health care
facilities
6. ISO 17665-1:2006 specifies requirements for the
development, validation and routine control of a moist
heat sterilization process for medical devices.
4.11.2. Quality standards
The manufacturing plant meets the following quality
standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.
3. 21 CFR 820 – Quality System
Page 16 of 57
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