Tuttnauer ELARA9-D User manual

Technician Manual
Pre-vacuum Steam Sterilizer with Generator
Models ELARA9-D, ELARA11-D
Cat. No. MAN205-0498000EN Rev D
Tuttnauer Europe B.V.,
Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda, The Netherlands
Tel: [phone], Fax: [phone]
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TABLE OF CONTENTS
1General 5
1.1 Incoming Inspection 5
1.2 Warranty 5
1.3 Warranty Statement 6
2Safety Instructions 7
3General Information 8
3.1 Intended Use 8
3.2 Introduction 8
3.3 Operating Conditions 9
3.4 Stickers Description 9
3.5 Periodical Tests 10
3.6 Specifications 11
3.7 Generator Steam Data 15
3.8 Autoclave Electrical Data 15
3.9 Utilities 16
3.10 Environment Emission Information 16
3.11 Water Quality 16
3.12 Directives and Standards 17
4Installation 18
4.1 Lifting and carrying 18
4.2 Unpacking the autoclave 18
4.3 Installation preparations 19
4.4 Placing the Autoclave 19
4.5 Connections to Utility Supplies 19
4.6 Operating the autoclave 20
4.7 Final adjustments 20
5TESTS 21
5.1 Installation Tests 21
5.2 Periodical Tests 21
6Description of the control system 23
6.1 Block Diagram Hardware Software Components 23
6.2 Application System Architecture 23
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6.3 Description of the programmable component: 24
6.4 Software development plan: 26
7Control Panel 30
7.1 Description and Functions of the Front Panel 30
7.2 Displayed Error Messages / Symbols 33
7.3 Displayed operational messages / Symbols 33
8Screens 35
8.1 Screens showing a successfully completed cycle 35
8.2 Screens showing aborted cycles after a completed sterilization stage 36
8.3 Screens showing a Failure occurrence after a completed sterilization
stage 37
8.4 Screens showing a failed cycle: 37
8.5 Screens showing a failure because of a Heat Time Error 37
9Checking and Changing Parameters And Other Data 39
9.1 Browsing through the menus 39
9.2 Changing a Parameter 40
9.3 Quick options screen 42
9.4 Logging in and entering the Main menu 48
9.5 Directories and subdirectories 50
9.6 System Parameters 53
9.7 Inputs/Outputs 55
9.8 Maintenance 61
9.9 Advanced Options 65
9.10 Version handling 71
9.11 Cycle parameters 74
9.12 Temperature sensors 77
9.13 Displayed inputs 77
9.14 Purge (generator models only) 78
9.15 Create Pulse 79
9.16 Keep Heat 80
9.17 Heating 82
9.18 Sterilization 82
9.19 Cooling (“C” models only) 83
9.20 Exhaust 84
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9.21 Drying 84
9.22 Ending 86
9.23 Global (for some models only) 87
9.24 Preliminary Operations for Each Technician Call 89
9.25 Draining the Reservoirs 90
9.26 Safety tests after repair 91
10 Maintenance and Replacement Procedures 92
10.1 Preliminary Operations for Each Technician Call 92
10.2 Dismantling the Outer Cover of the Autoclave 92
10.3 Emergency Door Opening 93
10.4 Replacing the jacket heating elements 95
10.5 Replacing the PT100 Temperature Sensor and cut –off thermostat of
the jacket heater 96
10.6 Replacing the Water Reservoir Water Electrodes 97
10.7 Replacing the Drain Valves 97
10.8 Replacing the water filling pipe. 99
10.9 Replacing the Door Cover 99
10.10 Replacing the door safety microswitch 100
10.11 Replacing the main switch 101
10.12 Replacing the Air Filter 102
10.13 Replacing the circuit breaker 102
10.14 Replacing the Door Safety Microwitch (“Door switch”) 104
10.15 Replacing the Solid State Relay (SSR) 105
10.16 Replacing the Transformer. 106
10.17 Replacing the fuse of the transformer 106
10.18 Replacing the Safety Valve 107
10.19 Replacing the steam generator heating elements 108
10.20 Replacing the steam generator cut-off thermostat 109
10.21 Replacing and cleaning the generator’s water level electrode 110
10.22 Replacing the Drain Valve 111
10.23 Replacing the door gasket 111
10.24 Replacing the Front Panel 113
10.25 Replacing the Printer Door 114
10.26 Replacing the Door Handle 115
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10.27 Replacing the Plastic Handle Cover 116
10.28 Replacing the Printer 117
10.29 Replacing the paper roll 118
10.30 Replacing the Door Switch 119
10.31 Replacing the water pump 121
10.32 Replacing the Plunger or Coil of the Solenoid Valve 122
10.33 Replacing the internal PT100 123
10.34 Replacing the Chamber and Generator Pressure Transducers 124
10.35 Replacing the pressostat 125
10.36 Replacing the door locking solenoid 126
11 Troubleshooting 128
12 List of Spare Parts 135
13 Pressure vs Temperature for Saturated Steam 153
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1General
Caution!
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 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 one year against faulty components and assembly.
This warranty does not include routine cleaning and preventive
maintenance to be performed according to instructions in
sec. 12.1 (Preventive and Scheduled Maintenance).
Tuttnauer warrantees all new autoclaves for a period of one full year, 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.
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
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authorized Tuttnauer dealer. No other warranties or obligations are expressed
or implied.
Warning
Only United States Food and Drug Administration cleared accessories
such as sterilization wraps, sterilization pouches, chemical indicators,
biological indicators, and sterilization cassettes should be used with this
autoclave. Sterilization programs 1,2,3,4,5,6,7 and 8 are not considered by
the Food and Drug Administration to be standard sterilization cycles.
There are currently no sterilization wraps, sterilization pouches, chemical
indicators, biological indicators, or sterilization cassettes cleared for use
by the Food and Drug Administration for the specific sterilization
parameters of sterilizer programs 1,2,3,4,5,6,7 and 8.
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
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: [phone], Fax: [phone], Email: [e-mail]
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.
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2Safety Instructions
The autoclave has unique characteristics. Please read and understand this
technician manual before first operation of the autoclave.
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. 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".
6. Verify once again that you have chosen the appropriate sterilization
program.
7. Open the door slowly to allow steam to escape and wait 1 minute before
you remove the load.
8. When removing the trays it is recommended to use the tray handle or
wear heat resistant gloves.
9. Once a month, ensure that the safety valve is operating.
10.A certified inspector must perform a periodic pressure chamber safety
test according to the local regulations.
11.Once annually, or more frequently, effectiveness tests must be
performed, i.e., calibration and validation.
12.Make sure there are no leaks, breaks, blockages, whistles or strange
noises.
13.Perform maintenance operations as instructed. The owner of the
autoclave is responsible to perform the maintenance operations.
14.Notify the person in charge immediately of any deviation from the
normal functioning of the device.
15.Protective equipment and clothes and other safety instructions should
be implemented in accordance with local and national regulations and/or
rules!
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3General Information
3.1 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.
3.2 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 operator’s
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
operator’s 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.
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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.
Warning
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.
3.3 Operating Conditions
This device is for indoor use only!
The sterilizer should be loaded only with autoclavable material!
Minimum room ventilation shall be 10 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)).
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
3.4 Stickers Description
Symbol
Meaning
Part Number
Location
Caution! Consult
accompanying
documents
LAB048-0024
Near the main power
electric cable socket,
and on the front door
upper-left corner
Caution! Hot steam.
LAB048-0058
On the top cover near
the water reservoirs
opening (hot steam
emerges out of the
safety valve located
inside the reservoirs)
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3.5 Periodical Tests
PERIOD
TEST
1 month
Test the safety valve by operating it.
6 months
Remove the autoclave’s cover, tighten the heaters’ screws and
electrical connections, valves and connectors in the control box.
Year
Check the continuity of the grounding connections.
Check the temperature and pressure calibration.
Perform validation of the autoclave.
Check the precise operation of the earth leakage relay.
Check that the autoclave is leveled.
Check the safety elements; safety valve, safety and cut-off
thermostats door locking mechanisms.
Run basic programs of the autoclave and check the operation
sequences, the sterilization parameters etc.
Check the water reservoir, piping, plastic parts and electric
wires.
Check and tighten the piping joints to avoid leakage.
Check and tighten all screw connections in the control box,
heaters and valves and instrumentation.
Calibrate the temperature and pressure once a year or in
reference to local rules or regulations (refer to the section on
Calibration).
5 years
Observe the closing device for excessive wear
Safety tests (pressure vessel, efficiency, electrical) shall be performed in
accordance with local rules or regulations, by an authorized inspector.
Only an authorized technician shall perform the 6-months and
yearly tests!
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3.6 Specifications
Overall Dimensions: ELARA 9-D
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Overall Dimensions: ELARA 11-D
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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
5
4
6
8
9
10
11
12
1
2
3
7
14
13
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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
5
4
8
1
2
3
6
7
9
10
11
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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
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.
3.7 Generator Steam Data
Property
Value
Max. working pressure
3 BarG
Safety relief valve
5 Bar
3.8 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
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3.9 Utilities
Property
Value
Mineral free water
See table in 错误!未找到引用源。
Power supply
* 1 phase, /230VAC ±10%, 50Hz
Recommended
circuit breaker
16A
* According to the local network.
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.
3.10 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.
3.11 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 steam for sterlizers
(According to EN 13060:2004).
Element
Condensate –allowable content
Silicium oxide. SIO2
≤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
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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.
Note:
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.
3.12 Directives and Standards
Every autoclave meets the provisions of the following Directives and is in
compliance with the following Standards:
Technical Directives
Medical Device Directive 93/42/EEC.
Pressure Equipment Directive 97/23/EEC.
Technical Standards
EN 13060:2010 ― Small Steam Sterilizers.
EN 61326 ― Electrical equipment for measurement, control and
laboratory use-EMC requirements
IEC/EN 61010A-1 ― electrical equipment for laboratory use; general
requirements
IEC/EN 61010A-2-040 ― particular requirements for sterilizers and
washer disinfectors used to treat medical materials.
Quality standards
The manufacturing plant meets the following quality standards:
EN ISO 9001:2008 –Quality System.
ISO 13485:2003 –Quality systems –Medical devices.
The manufacturer retains all supporting documentation.
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4Installation
Caution!
The installation and all operations described in this chapter must be
done only by an authorized technician.
The sterilizer must be placed on a rigid and leveled surface. The stand
must be able to withstand the load of the device and loaded material.
ELARA9,
ELARA11
Counter top able to
support a minimum
of
70 kg
(155 lb)
85 kg
(188 lb)
Minimum Counter
dimensions (W x D)
51cm x
63cm
(20” x 25”)
56cm x
63cm
(22” x 25”)
4.1 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 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!
4.2 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.
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4.3 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 lb (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 4” (10 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.
Note:
Insufficient space for ventilation may result in an increase of the autoclave's
temperature that may cause a malfunction or damage the instrument.
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%
9. To update the atmospheric pressure in the autoclave, keep the
chamber's door open for approx. 5 minutes. The system will be updated
automatically.
4.4 Placing the Autoclave
Keep all the sides of the autoclave approximately 3” (75.2 mm) away from the
wall to allow ventilation.
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 damage the instrument.
It is recommended that enough space be left around the autoclave to give a
technician access for servicing the machine.
4.5 Connections to Utility Supplies
1. Check and verify that the power supply is a 1 phase, 230Vac ±10%,
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.
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