operation maintenance manual

operation maintenance manual
OPERATION
&
MAINTENANCE
MANUAL
Laboratory Vertical Steam Sterilizers
Including Fast Cooling System
models 3840, 3850, 3870
ELV/WR/C/PV/BH/F-D
Cat. No. MAN205-0448002EN Rev C
 Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540
 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 CONTENTS
PARAGRAPH
1.
2.
3.
4.
5.
6.
PAGE NO.
GENERAL ............................................................................................................4
1.1 Introduction .................................................................................................4
1.2 Incoming Inspection ....................................................................................5
1.3 Warranty ......................................................................................................6
1.4 Warranty Statement .....................................................................................6
1.5 Accessories...................................................................................................7
SAFETY INSTRUCTIONS ..................................................................................8
TECHNICAL DATA........................................................................................... 10
3.1 Storage Conditions.....................................................................................10
3.2 Operating Conditions.................................................................................10
3.3 Directives and Standards ...........................................................................10
3.4 Environment Emission Information ......................................................... 11
3.5 Electrical Data ........................................................................................... 11
3.6 Specifications ............................................................................................. 11
3.7 Construction .............................................................................................. 12
3.8 Utilities.......................................................................................................12
3.9 Symbol Description ....................................................................................13
3.10 Description of Operation ...........................................................................21
3.11 Water Quality............................................................................................. 23
3.12 Safety Features .......................................................................................... 24
CONTROL PANEL ............................................................................................ 25
4.1 Description and Functions of the Front Panel Keyboard ......................... 26
4.2 Displayed Error Messages / Symbols......................................................... 28
4.3 Displayed operational messages / Symbols................................................29
STERILIZATION PROGRAMS.........................................................................30
5.1 Program 1: Glass ....................................................................................... 32
5.2 Program 2: Plastic .....................................................................................33
5.3 Program 3: Liquid A..................................................................................34
5.4 Program 4: Liquid B – Waste ....................................................................35
5.5 Program 5: Liquid A – Cooling .................................................................36
5.6 Program 6: Liquid B – Waste Cooling ...................................................... 37
5.7 Program 7: Vacuum Test (PV model only) ...............................................38
5.8 Program 8: Bio Hazard Liquid Cooling ....................................................39
5.9 Program 9: Bio Hazard Liquid..................................................................40
5.10 Program 10: Bio Hazard ...........................................................................41
CHECKING AND CHANGING PARAMETERS AND OTHER DATA ...........42
6.1 Directories and subdirectories ...................................................................42
6.2 Table of parameters ...................................................................................43
6.3 Entering the main menu ............................................................................44
6.4 Cycle Parameters (Custom 1) ....................................................................45
6.5 System Parameters.....................................................................................50
Page 1 of 88 Pages
7.
8.
9.
10.
11.
12.
13.
14.
15.
6.6 History........................................................................................................52
6.7 Maintenance .............................................................................................. 54
6.8 Advanced Options ...................................................................................... 58
6.9 Version information...................................................................................60
SCREENS ...........................................................................................................63
7.1 Screens following a complete successfully cycle – "Cycle Ended" ..........63
7.2 Screens following aborted cycles after complete sterilization stage ..........63
7.3 Screens following a fail cycle: ...................................................................64
PRINTER............................................................................................................65
8.1 Printer Output............................................................................................ 65
8.2 Printer Handling........................................................................................ 67
PREPARATION BEFORE STERILIZATION ..................................................70
9.1 Instruments ................................................................................................ 70
9.2 Liquids .......................................................................................................71
9.3 Loading ......................................................................................................71
OPERATION ......................................................................................................72
10.1 Filling the water reservoir (WR configuration only) ................................ 72
10.2 Turning on the autoclave...........................................................................72
10.3 Opening the door ....................................................................................... 73
10.4 Loading ......................................................................................................73
10.5 Closing the door......................................................................................... 74
10.6 Starting cycle ............................................................................................. 75
10.7 Unloading ..................................................................................................76
10.8 Stopping the process and cancelling the ERROR message ....................... 76
10.9 Start Cycle by Clock mode .........................................................................76
10.10Moving the Autoclave ................................................................................77
10.11Loading and Unloading the Device ........................................................... 77
DOOR SAFETY SYSTEM..................................................................................78
11.1 Electric door locking system ......................................................................78
11.2 Pressure switch .......................................................................................... 78
SERVICE AND MAINTENANCE .....................................................................79
12.1 Preventive Maintenance ............................................................................79
12.2 Checking the Safety Valve .........................................................................80
12.3 Draining the Reservoir ..............................................................................81
TROUBLESHOOTING ...................................................................................... 83
SPARE PARTS LIST.......................................................................................... 88
ACCESSORIES ..................................................................................................88
Page 2 of 88 Pages
TABLE OF CONTENT (Cont.)
DRAWINGS
PAGE NO.
FRONT VIEW (STANDARD CONFIGURATION) ............................................. 14
FRONT VIEW (WR CONFIGURATION) ............................................................ 15
FRONT VIEW (FAN CONFIGURATION) .......................................................... 16
REAR VIEW (STANDARD CONFIGURATION) ................................................ 17
REAR VIEW (WR CONFIGURATION) ............................................................... 18
OVERALL DIMENSIONS (STANDARD CONFIGURATION, mm) .................. 19
OVERALL DIMENSIONS (WR CONFIGURATION, mm)................................. 20
CONTROL PANEL DRAWING ............................................................................ 25
BASKETS AND CONTAINERS ........................................................................... 87
Page 3 of 88 Pages
1.
GENERAL
1.1
Introduction
A computerized control unit ensuring a fully automatic sterilization
cycle controls the autoclave.
The temperature and pressure are controlled through sensors placed
inside and outside the media container or bottles.
The sterilizer is fully automatic with a choice of 10 programs,
eliminating any need for operator intervention during a cycle program
7 are for vacuum test only). A computerized control unit enables
precise control and monitoring of physical parameters and clear
documentation of the sterilization cycles.
The autoclave is equipped with a safety valve, which will discharge at
an overpressure of over 2.8 Bar (40 psi), which is located on the
chamber near the pressure switch and the steam pressure gauge. The
control system provides adequate protection, to ensure the safety of
personnel and reliable operation with a minimum of down time.
The sterilizer has multiple built - in safety devices, which provides
adequate protection to ensure the safety of operating personnel.
On all models, a printer is an optional addition to the autoclave. The
printer prints the preset and actual parameters of the cycle
(temperature, time and pressure).
The autoclave is provided with a pressure gauge that is used as 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.
A deviation of +1.6% is accepted.
NOTE:
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 easily be removed, and will not have
any effect on the sterilized goods.
This manual is intended to give the user a general understanding of
how the autoclave works and indicates the best ways to operate and
take care of it in order to obtain optimum results and a trouble-free
operation. After reading this manual, operating the autoclave should be
straightforward. However, since the autoclave is built using 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, holding
technical documentation and adequate test instrumentation are
authorized to undertake repair or service.
Page 4 of 88 Pages
Available optional configurations
Models of 3870 ELV model range -D are laboratory sterilizers
designed especially for the sterilization of instruments, liquids, and
other materials in hospital laboratories, medical laboratories, research
institutes, food laboratories and pharmaceutical facilities.
C
A special feature of the ELVC-D models is the fast cooling stage for
liquids. In this stage pressure in the chamber is increased by means of
compressed air to compensate the fast decreasing of pressure due to the
fast cooling. The fast cooling shortens the time required for safe
handling of bottles.
Note: there is no cooling option for WR configuration
PV
Special feature of ELVCPV-D models is the vacuum pump that enables
air removal prior to sterilization and during the drying stage.
The advantages of the pre-vacuum sterilizer in comparison to the
regular gravity displacement steam sterilizer are as follows:
— Removal of air pockets from packs and porous loads 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.
— Better drying of materials with closed doors due to the vacuum
achieved in the chamber at the end of the sterilization cycle.
A special feature of the autoclave is the fast cooling stage for liquids.
In this stage pressure in the chamber is increased by means of
compressed air to compensate the fast decreasing of pressure due to the
fast cooling. The fast cooling shortens the time required for safe
handling of bottles
There is a configuration equipped with fan that allows to shorten the
cooling operation.
BH
In ELVCPVBH-D (bio-hazard) models, a bio-hazard filter installed in
the chamber enables sterilizing bio-hazard load without contaminating
the surrounding.
WR
In ELVWR-D (Water recycling) models, water is saved by the water
saving system, because it recycles the water and re-uses it for each
cycle.
1.2
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.
Page 5 of 88 Pages
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.
1.3
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 sec. 12.1 (Preventive 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 products that have been repaired or
altered outside the factory without prior authorization from us.
The Autoclave should not be used in a manner not 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 Technical Service Depts can be reached at:
 Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540, E-mail: info@tuttnauer.nl
 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 6 of 88 Pages
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 products 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.
1.5
Accessories
Basket accessories: A set of two baskets is available for the unit. The
baskets are made of stainless steel wire and have a handle. The basket
allows the operator to load a large quantity of materials into the
chamber.
The pressure scale, printer option and cooling method can be set up at
any time by a technician.
Stainless steel containers: A stainless steel container, for waste
products, is available. This container has vent holes on its upper part
Page 7 of 88 Pages
2.
SAFETY INSTRUCTIONS
The autoclave has unique characteristics. Please read and understand the
operation instructions before first operation of the autoclave. The following
issues may require instructions guidance provided by the manufacturer: how to
operate the autoclave, the door safety mechanism, the dangers involved in
circumventing safety means, how to ensure that the door is closed, and how to
select a correct sterilization program.
Make sure that you know where the main power switch is, where the water
cut-off valve is and where the compressed air disconnection valves (if
applicable) are located.
Autoclave maintenance is crucial for the correct and efficient function of the
device. We enclose a log booklet that includes maintenance recommendations,
with every device.
The weekly spore test is part of the preventive maintenance plan, along with
the annual validation of the sterilization processes that ensures appropriate
temperature dispersion within the chamber.
Never use the autoclave to sterilize corrosive products, such as: acids, bases
and phenols, volatile compounds or solutions such ethanol, methanol or
chloroform nor radioactive substances.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Never start using a new autoclave before the safety, licensing and
authorization department has approved it for use.
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.
A written procedure must be established for autoclave operation,
including: daily safety tests, seal inspection and door hinge inspection,
smooth action of the closing mechanism, chamber cleaning, prevention
of clogging and preservation from corrosion, what is permitted and
what is prohibited for sterilization and choosing a sterilization
program.
Liquids may be sterilized only with the “liquids” programs. The
container must be covered but not sealed. Sealed bottles may only be
sterilized using a special program. The bottle must be either Pyrex or a
Borosilicate glass bottle. Verify that the two temperature sensors are
located inside two different bottles to assure that the liquid temperature
is 20°C below boiling temperature for sealed bottles at the end of the
cycle.
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.
Individual glass bottles may be placed within an appropriate container
that will be placed in a basket. Never place glass bottles on the floor of
the autoclave. Never fill more than 2/3 of the bottle volume.
On closing the autoclave's door, make sure it is properly locked before
activating.
Before withdrawing baskets, wear heat resistant gloves.
Before opening the door, verify that there is no pressure in the chamber
(chamber pressure gauge is located on the autoclave's front panel or
door, depends on model).
Page 8 of 88 Pages
10.
11.
12.
13.
14.
15.
16.
17.
Open the door slowly to allow steam to escape and wait 5 minutes
before you remove the load. When sterilizing liquids, wait 10 minutes.
Once a month, ensure that the safety valves are functioning, and once
annually a certified tester must conduct pressure chamber safety tests.
Once annually, or more frequently, effective tests must be performed,
i.e., calibration and validation.
Examine the condition of assemblies on a regular basis. Make sure
there are no leaks, breaks, blockages, whistles or strange noises.
It is required to conduct maintenance operations as instructed.
Immediately notify the person in charge of any deviation or risk for the
proper function of the device.
For WR models, drain the water from the mineral free water reservoir
once a week, and refill with fresh mineral-free water or distilled water
(see sec. 12.3).
This autoclave equipped with rear and front wheels, when moving the
autoclave all utilities must be disconnected, at least 2 persons shall
move the autoclave with caution. When the autoclave located in the
required place, the wheels have to be locked. For further information
see the front/rear view of the autoclave.
Page 9 of 88 Pages
3.
TECHNICAL DATA
3.1
Storage Conditions
The packed or unpacked autoclave shall be retained in indoor
conditions!
3.2
Operating Conditions

The autoclave is intended to work in ‘indoor’ conditions only.

Only autoclavable materials shall be used.

The environment shall not exceed an ambient temperature range of
5ºC (41ºF)-40ºC (104ºF) and a relative humidity of 85%
respectively.
 The operation altitude shall not be over 2000 meters (6561 feet)
(ambient pressure shall not be lower than 80 kPa (11.6 psi)).
 The autoclave shall not be used in a manner not specified in this
manual!
 Do not use the autoclave in the presence of dangerous gases.
 The packed or unpacked device shall be stored in ‘indoor’
conditions.
 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 i.e. only non-hazardous liquids shall
be disposed in public sewage!
3.3
Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
3.3.1
Technical Standards
1. AAMI/ANSI ST 8.
2. ASME Code Sec. VIII for Pressure Vessels.
3. Pressure Equipment Directive 97/23/EEC.
4. EN 285:2006 ― Sterilization , Steam sterilizers , Large
sterilizers
5. IEC/UL 61010A-1 ― electrical equipment for
laboratory use; general requirements.
6. IEC 61010-2-040 ― particular requirements for
sterilizers and washer disinfectors used to treat medical
materials.
7.
ISO 17665 ― 1:2006 Sterilization of health care
products moist heat.
Page 10 of 88 Pages
3.3.2
3.4
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.
Environment Emission Information
A. Peak sound level generated by the sterilizer is « 70 / dBA with a
back sound level of 60 dBA.
B. Total heat transmitted by the sterilizer is < 100 W/h
3.5
Electrical Data
Ampere (A)
208V
version
16A
230V
version
16A
380V
version
10A
Voltage (V)
208V/3ph
230V/3ph
380V/3ph
Hertz (Hz)
50/60 Hz
50/60 Hz
50/60 Hz
Heaters power (W)
6000
6000
6000
Protection against electrical shock
Class I
Class I
Class I
Degree of protection by enclosure
IP31
IP31
IP31
PROPERTIES
3.6
Specifications
MODEL
PROPERTIES
Chamber diameter
Chamber depth
Effective Chamber volume
Height
Overall dimensions Width
Length
Maximum
dimensions
(door open)
Mineral-free water
reservoir
Width
Length
Max. water
volume
3840
3850
3870
380 (15”) 380 (15”) 380 (15”)
400
480
680
(15.8”)
(18.9”)
(26.8”)
52 liters.
65 liters.
85 liters.
(11 US
(17 US
(22 US
gal.)
gal.)
gal.)
847
847
996
(33.3”)
(33.3”)
(39.2”)
727
727
727
(28.6”)
(28.6”)
(28.6”)
500
500
500
(19.7”)
(19.7”)
(19.7”)
782 (30.8”) 782 (30.8”) 812 (32.0”)
1336
1336
1486
(52.6”)
(52.6”)
(58.5”)
28 litres
(7.4 US
gal.)
Min. water
volume
Page 11 of 88 Pages
83 kg
(183 lbs)
0.56 m3
(17.98 ft3)
99 kg (218
lbs)
Net weight (kg)
Shipping volume
Shipping weight
Max. Allowable Working pressure
(MAWP)
3.7
100 kg
(220 lbs)
0.56 m3
(17.98 ft3)
116 kg
(255 lbs)
2.8 bar (40 psi)
Construction
Chamber and door material
Stainless steel
Outer Cabinet
Stainless Steel
Chamber insulation
Fiberglass with reinforced material
Water reservoir
3.8
85 kg
(187 lbs)
0.56 m3
(17.98 ft3)
101 kg
(222 lbs)
Stainless Steel
Utilities
3.8.1
Electrical utility
Power
Switch box
208-220V (3 Ph + Earthing)
380-400V(3 Ph + Neutral +
Earthing)
230V 1ph
Frequency
3.8.2
Recommended
Circuit Breaker
No
20A
No
16A
yes
32A
50/60Hz
Other Utilities
Compressed Air (ELVC only)
1/2" 3-4 Bar (44-58 psi)
Tap water
1/2", 2-3 Bar (29-44 psi)
Mineral free water
Drain
1/2", 2-3 Bar (29-44 psi)
2" Minimum Withstanding temp.
of 80°C (176°F)
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.
 Make sure while placing the autoclave, to leave space around the
machine, to give the technician access to service the machine.
Page 12 of 88 Pages

3.9
All water connections to autoclave must be performed through
"BACK FLOW PREVENTION SYSTEM" only, as per IEC
61770.
Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)
On-Off
Page 13 of 88 Pages
FRONT VIEW (STANDARD CONFIGURATION)
5
6
7
8
9
10
11
4
12
3
13
2
14
1
15
No.
Description
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Front leg
Rear leg
Left service door
Left service door grip
Left service door lock
Door cover
Pressure gauge
Display
Keyboard
Printer cover
Paper slot and paper cutter
USB socket
RJ45 connector
Main switch
Printer
Page 14 of 88 Pages
FRONT VIEW (WR CONFIGURATION)
5
6
7
8
9
10
11
4
12
3
13
2
14
1
15
No.
Description
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Front leg (with brakes)
Rear leg
Front service door
Right service door grip
Right service door lock
Door cover
Pressure gauge
Display
Paper slot and paper cutter
Printer cover
Keyboard
USB socket
RJ45 connector
Printer
Main switch
Page 15 of 88 Pages
FRONT VIEW (FAN CONFIGURATION)
There is a configuration equipped with a fan that allows to shorten the cooling
operation. The fan is located on the door of the autoclave.
Fan
Page 16 of 88 Pages
REAR VIEW (STANDARD CONFIGURATION)
5
6
7
8
9
4
10
3
11
2
12
13
1
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
Description
Drain outlet
Mineral free water inlet
Compressed air inlet
Cavitation port
Power supply electrical cord
Cut-off
Fan grill
Safety Valve
Circuit breaker
Ground connector
City (tap) water inlet for cooling coil
Air pressure gauge
Air pressure regulator
Page 17 of 88 Pages
REAR VIEW (WR CONFIGURATION)
4
5
6
7
8
9
10
11
3
12
2
13
1
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
Description
Rear wheel
Water reservoir drain
Water reservoir overflow
Power supply electrical cord
Cut-off
Fan grill
Safety valve
Circuit breaker
Left service door lock
Back service door handle
Water reservoir door handle
Left service door handle
Front wheel (with brakes)
Page 18 of 88 Pages
OVERALL DIMENSIONS (STANDARD CONFIGURATION, mm)
Page 19 of 88 Pages
OVERALL DIMENSIONS (WR CONFIGURATION, mm)
Page 20 of 88 Pages
3.10
Description of Operation
3.10.1
3.10.2
3.10.3
3.10.4
Air removal (optional)
IN PV (pre-vacuum) models, the autoclave is equipped with
a vacuum pump for performing the air removal stage. Before
the sterilization stage, one or two vacuum pulses (according
to the cycle) are built in the chamber. Removing air pockets
in the autoclaved material improves the penetration of the
steam during the sterilization stage.
Heat
The ELV vertical autoclaves are equipped with immersion
type heating elements. After water has been introduced to the
chamber (In WR models (unlike other models), water is
forced into the chamber form the water reservoir by the
water pump, and not by pressure of the utility supply.) and
the air removal stage has been completed, the heating
elements begin to heat. The temperature and pressure in the
chamber increase until appropriate levels are reached.
Sensors located inside the chamber control the temperature
and pressure levels.
Sterilization
The sterilization temperature is factory set at 134C (273F)
for instruments and at 121C (250F) for liquids and other
materials for which this temperature is appropriate. These
settings may be modified before each cycle. When
sterilization temperature is reached, the timed sterilization
cycle begins.
Cooling (Optional)
The ELVC autoclaves are designed to operate two liquid
cooling cycles, as follows:
Sealed bottles (cooling with compressed air)
On completion of the sterilization stage, feed
water starts flowing through the cooling coil
mounted around the outer side of the chamber.
Compressed air is injected inside the chamber and
keeps a constant air pressure to balance the
internal pressure of the liquids inside the bottles.
Compressed air is passed through a 0.2µ
microbiological filter. When temperature of the
liquids reaches the final set temperature, the
cooling stage is completed, flowing water and
compressed air is stopped, pressure in the chamber
goes down to atmospheric pressure.
At this stage, the door of the autoclave can be
opened and the sterilized materials can be taken
out of the chamber.
Unsealed bottles (cooling without compressed air)
On completion of sterilization, steam is exhausted
from the chamber at a slow rate. When chamber
pressure goes down to atmospheric pressure, water
Page 21 of 88 Pages
starts flowing through the cooling coil mounted
around the outer side of the chamber. On
conclusion of the cycle the water flow is stopped
automatically, process is completed and it is
possible to open the door and take out the
sterilized goods from the chamber.
3.10.5
Exhaust
When the timed sterilization cycle is complete, the unit
enters the exhaust stage, provided that a program other than
the liquid program was selected. The steam is exhausted
from the chamber, bringing the internal pressure down to
atmospheric pressure. In WR models, the steam goes back to
the water reservoir and is cooled to become water again.
Note:
In the Bio-Hazard cycles (BH, bio-hazard models), all
exhaust from the chamber before completion of the
Sterilization phase are performed through the bio-hazard
filter.
Drying (PV – pre-vacuum nodel only)
3.10.6
Drying stage; vacuum is built up and the coil heats the
chamber for time set in Dry Time parameter.
3.10.7
Vacuum Test Program (PV – pre-vacuum model only)
Vacuum is produced in the chamber down to P1=15 kPa. At this stage
all the valves close. The autoclave remains in this stage for 5 minutes.
This period enables the condition in the chamber to reach
equilibrium. After the 5 minutes have elapsed the printer records the
pressure that is referred to as P2. At this point the test begins and lasts
10 minutes. At the end of the test, the printer records the results. The
pressure at the end of the test is referred to as P3. The rate of change
of P3-P2 shall not exceed 0.13 kPa/min.). If P3-P2 exceed 0.13
kPa/min the printer will print “FAIL”. If P3-P2 is within the required
value, the cycle will end normally.
Operations Sequence
Vacuum is produced into the chamber down to 15-5 kPa.
The vacuum pump stops.
Note: During the test period the autoclave is not heated.
Page 22 of 88 Pages
3.11
Water Quality
3.11.1
Water for Steam Generation
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 sterilizers
(According to EN 13060:2004).
Condensate – allowable
Element
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,
≤0.1 mg/kg
cadmium, lead
Chloride (Cl)
Phosphate (P2O5)
Conductivity (at 20°C)
pH value (degree of acidity)
Appearance
Hardness (Σ Ions of alkaline
earth)
≤0.1 mg/kg
≤0.1 mg/kg
≤3 μs/cm
5 to 7
Colourless clean
without sediment
≤0.02 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.
3.11.2
Drain Cooling
The feed water supplied to the drain cooling must meet the
following requirements:

Hardness: 0.7 - 0.2 mmol/l.

Water temperature shall not exceed 15°C (59°F).
Page 23 of 88 Pages
3.11.3
Reverse Osmosis
A Reverse Osmosis (RO) system may be used to improve the
quality of the water used to generate steam in the autoclave
chamber.
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:
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.
3.12
Safety Features
This autoclave includes built-in safety features such as:
 Error message display.

Electronic pressure and temperature measurement.

Safety relief valve to avoid build-up of excessive pressure.

Door switches enabling operation to be started only when the door
is closed.

Water level safety device.

Excess temperature protection.
Page 24 of 88 Pages
4.
CONTROL PANEL
CONTROL PANEL DRAWING
1
2
3
No.
Description
1
Display
2
Keypad
3
Printer
Page 25 of 88 Pages
4.1
Description and Functions of the Front Panel Keyboard
The front panel is composed of 3 sections:
1. Display screen.
2. Keypad.
3. Printer
4.1.1
Display screen
The display is a LCD panel used to display the current status
of the autoclave while using Operational Messages and Error
Messages.
Program description:
Program icon and name
 Sterilization temperature
 Sterilization time
Chamber temperature No. 1
Chamber temperature No. 2
 System status
 Name of stage
 Error and operational
messages
Chamber pressure
Page 26 of 88 Pages
4.1.2
Keypad
The keypad consists of three keys as described below:
UP key
This key has the following functions:
 In the menu directories:
o This key enables the operator to browse
through the cycles.
 In the directories available:
o When the cursor is blinking on a number,
the UP ▲ key increases its value.
o When the cursor is blinking on a menu
selection, the UP ▲ key allows browsing
backward through the menu.
o When adjusting a parameter and the cursor
is blinking on “SET” or “EXIT” the UP ▲
key activates that procedure.”
DOWN key
This key has the following functions:
 In the menu directories:
o This key enables the operator to browse
through the cycles.
 In the directories available:
o When the cursor is blinking on a number,
the DOWN ▼ key decreases its value.
o When the cursor is blinking on menu
selection, the DOWN ▼ key allows
browsing forward through the menu.
o When adjusting a parameter and the cursor
is blinking on “SET” or “EXIT” the
DOWN ▼ key activates that procedure.
START/STOP key
This key has the following functions:
 In the main screen:
o Starts the process when the required
program was chosen.
o Stops the current process.
o Cancels the ERROR message displayed on
the screen and opens the electric door lock.
 In the menu directories:
o When the cursor is blinking on a number,
the START/STOP
key enables moving
to the next position.
o When the cursor is blinking on a menu
selection, the START/STOP
key
activates that selection.
Page 27 of 88 Pages
4.1.3
4.2
Printer
The printer is an optional device.
It prints the detailed history of each cycle performed by the
autoclave. The printing is on thermal paper with 24 characters
per line and records the sterilization cycle information for
subsequent consideration.
Displayed Error Messages / Symbols
The failures are divided into two categories.
a. Failure that occur before completing the sterilization stage,
which in this case will leave the load unsterilized
b. Failure that occur after completing the sterilization stage, which
in this case will leave the load sterilized
For the list of Displayed Error Messages / Symbols
see sec. 13. TROUBLESHOOTING
Page 28 of 88 Pages
4.3
Displayed operational messages / Symbols
Message /
Symbol
Name
Message / Symbol
Description
This symbol is displayed
when the door is open.
Door is open
(during stand
by)
Cycle Ended
Test Ended
This symbol is displayed
when there is water in
chamber.
This message is displayed
when the door is opened: In
standby - if START/STOP
is preset.
This message is displayed
when the cycle ended
successfully.
This message is displayed
when the test ended.
This symbol is displayed
when Cycle by Clock
mode is performed.
Cycle by
clock
Atmospheric
pressure not
set
Critical
settings have
been updated,
Please restart
machine in
order for
changes to be
updated
This message is displayed
if the user presses
START/STOP key while
the "cycle by clock" mode
is active.
This message id displayed
in order to set the
atmosphere pressure by
opening the door for 5
minutes.
Required Action
Close the door.
Repeat the cycle
Close the door to perform a
new cycle.
Press START/STOP in
order to perform a new
cycle.
Press START/STOP in
order to perform a new test
Enter the Admin menu as
described in this manual to
change the time or to
cancel this option.
Enter the Admin menu as
described in this manual to
change the time or to
cancel this option.
Open the door for 5
minutes in order to set the
Atmospheric pressure.
If a change of the
autoclave setting was
made, a restart operation is
required.
Restart the autoclave in
order for changes to be
updated.
This message is displayed
if the electrode in the
chamber senses water.
Perform a new cycle to
drain the chamber.
Page 29 of 88 Pages
5.
STERILIZATION PROGRAMS
The autoclave offers ten sterilization programs as follows:
Sterilization Programs
Icon
Program
Temp
Description
Sterilization
Time
(minutes)
Drying
Time
(minutes)
1
1
Glass
134°C
3
1
2
Plastic
121°C
15
3
Liquid A
121°C
15
4
Liquid B -- Waste
121°C
30
5
Liquid A – Cooling
121°C
15
6
Liquid B -- Waste
Cooling
121°C
30
7
Vacuum test
121°C
5 +10
8
Bio Hazard Liquid
Cooling
121
45
9
Bio Hazard Liquid
121
45
2
10
Bio Hazard
Page 30 of 88 Pages
134
30
Note:
The sterility of instruments processed in unwrapped cycles cannot be
maintained if exposed to non-sterile environment.
During the process, the stages of the cycle will be displayed on the screen:
The stages names are as follows:
Start
Pulse L (ELPV model only)
Pulse Low
Pulse High
Heating
Sterilization
Exhaust
Drying (ELPV model only)
Ending
Page 31 of 88 Pages
5.1
Program 1: Glass
For glass instruments, when the manufacturer recommends autoclaving
at temperatures of 134C (273F).
Nominal parameters default settings
 Sterilization temperature: 134C (273F).
 Sterilization time: 3 minutes.
 Drying time: 1 minute.
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 (PV model only) Drying stage; vacuum is built up and the coil heats
the chamber for 1 minute.
Note:
The sterility of instruments processed in unwrapped cycles cannot
be maintained if exposed to non-sterile environment.
Page 32 of 88 Pages
5.2
Program 2: Plastic
For plastic and other delicate instruments, when the manufacturer
recommends autoclaving at temperatures of 121C (250F).
Nominal parameters default settings
 Sterilization temperature: 121C (250F)
 Sterilization time: 15 minutes
 Drying time: 1 minute.
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 (PV model only) Drying stage; vacuum is built up and the coil heats
the chamber for 1 minute.
Note:
The sterility of instruments processed in unwrapped cycles cannot
be maintained if exposed to non-sterile environment.
Page 33 of 88 Pages
5.3
Program 3: Liquid A
For liquids when the manufacturer recommends autoclaving at
temperatures of 121C (250F) for 15 minutes.
Note: both PT100 temperature sensors must be inside the bottles
For proper sterilization, fill the bottles with approximately the
same amount of liquid.
Nominal parameters default settings
 Sterilization temperature: 121C (250F)
 Sterilization time: 15 minutes
Operations Sequence
 (PV model only) Air removal stage; four vacuum pulses removes air
by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Slow exhaust; steam is slowly exhausted from the chamber, until it
reaches the required end temperature (approx. 85ºC) and the
pressure equals the atmospheric pressure.
Page 34 of 88 Pages
5.4
Program 4: Liquid B – Waste
For liquids when the manufacturer recommends autoclaving at
temperatures of 121C (250F) for 30 minutes, such as liquid waste.
Note: both PT100 temperature sensors must be inside the bottles
For proper sterilization, fill the bottles with approximately the
same amount of liquid.
Nominal parameters default settings
 Sterilization temperature: 121C (250F)
 Sterilization time: 30 minutes
Operations Sequence
 (PV model only) Air removal stage; four vacuum pulses removes air
by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Slow exhaust; steam is slowly exhausted from the chamber, until it
reaches the required end temperature (approx. 85ºC) and the
pressure equals the atmospheric pressure.
Page 35 of 88 Pages
5.5
Program 5: Liquid A – Cooling
For liquids when the manufacturer recommends autoclaving at
temperatures of 121ºC. for 15 minutes.
Nominal parameters default settings
 Warm up temperature: 121C (250F).
 Warm up time: 15 minutes.
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Forced cooling to the required end temperature (approx. 85ºC),
while the pressure in the chamber remains the same as the
sterilization pressure, by supplying compressed air into the chamber.
The forced cooling shortens the cooling stage significantly.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
Page 36 of 88 Pages
5.6
Program 6: Liquid B – Waste Cooling
For liquids when the manufacturer recommends autoclaving at
temperatures of 121ºC.for 30 minutes, such as liquid waste.
Nominal parameters default settings
 Sterilization temperature: 121C (150F).
 Sterilization time: 30 minutes.
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Forced cooling to the required end temperature (approx. 85ºC),
while the pressure in the chamber remains the same as the
sterilization pressure, by supplying compressed air into the chamber.
The forced cooling shortens the cooling stage significantly.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
Page 37 of 88 Pages
5.7
Program 7: Vacuum Test (PV model only)
 Vacuum is produced in the chamber down to P1=15 kPa. At this
stage all the valves close. The autoclave remains in this stage for 5
minutes. This period enables the condition in the chamber to reach
equilibrium.
 After the 5 minutes have elapsed, the printer records the pressure
that is referred to as P2. At this point the test begins and lasts 10
minutes.
 At the end of the test, the printer records the results. The pressure at
the end of the test is referred to as P3. The rate of change of P3-P2
shall not exceed 0.13 kPa/min.).
 If P3-P2 exceed 0.13 kPa/min the printer will print “FAIL”. If P3-P2
is within the required value, the cycle will end normally.
Page 38 of 88 Pages
5.8
Program 8: Bio Hazard Liquid Cooling
For liquids when the manufacturer recommends autoclaving at
temperatures of 121ºC. for 45 minutes. All exhaust from the chamber
before completion of the Sterilization phase is performed through the
bio-hazard filter.
Nominal parameters default settings
 Sterilization temperature: 121C (250F)
 Sterilization time: 45 minutes
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20 kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Forced cooling to the required end temperature (approx. 85ºC),
while the pressure in the chamber remains the same as the
sterilization pressure, by supplying compressed air into the chamber.
The forced cooling shortens the cooling stage significantly.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
Page 39 of 88 Pages
5.9
Program 9: Bio Hazard Liquid
For liquids when the manufacturer recommends autoclaving at
temperatures of 121ºC. for 45 minutes. All exhaust from the chamber
before completion of the Sterilization phase are performed through
the bio-hazard filter.
Nominal parameters default settings
 Sterilization temperature: 121C (250F)
 Sterilization time: 45 minutes
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20 kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.
 Sterilization temperature is maintained constant during the
sterilization time.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
Page 40 of 88 Pages
5.10
Program 10: Bio Hazard
For instruments, when the manufacturer recommends autoclaving at
temperatures of 134C (273F) for 30 minutes. All exhaust from the
chamber before completion of the Sterilization phase are performed
through the bio-hazard filter.
Nominal parameters default settings
 Sterilization temperature: 134C (273F)
 Sterilization time: 30 minutes
 Drying time: 1 minute.
Operations sequence:
 (PV model only) Air removal stage; four vacuum pulses removes
air by drawing the chamber down to 20 kPa.
 Inserting water into the chamber.
 Heating by actuation of electrical heaters until the sterilization
temperature is reached.Sterilization temperature is maintained
constant during the sterilization time.
 Fast exhaust, steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 (PV model only) Drying stage; vacuum is built up and the coil heats
the chamber for 1 minute.
Page 41 of 88 Pages
6.
CHECKING AND CHANGING PARAMETERS AND OTHER DATA
The control system prevents changing programs if the door is closed. This
protection is intended to avoid program changes if the autoclave is loaded. If
the operator for example inserts the load into the chamber, closes the door and
leaves the room and another operator/user tries to change the program, the
operator/user will not be able to do this unless the door is opened and the load
inside the chamber can be seen.
6.1
Directories and subdirectories
The operator (Admin) may perform the following:
DIRECTORY
Cycle Parameters – applicable
only for Custom 1 and Custom 2
programs
System Parameters
History
Maintenance
Advanced options
Version information
SUBDIRECTORY
See sec. 6.4 “Cycle Parameters (Custom 1)”
Print Rate All
Print Rate Sterilization
Screen Saver
View old cycle history
Export history to USB
Set date and time
Export gain offset to USB
Printer test
Print all gain and offset
Start cycle by clock
Export all settings to USB device
View current version information
View factory default version information
View previous version information
Page 42 of 88 Pages
6.2
Table of parameters
The parameter default depends on the selected program. The following
table is an example to Custom 1 program
Parameters
Description
Default
Unit
Range
Resolution
Pulse A Count
Define the number of pulses in the first pulses group
3
#
0-10
1
Pulse A Stay
Time
Define the additional time that the vacuum pump will continue
to operate or slow/top exhaust valve will remain open after
reaching the preset pressure in the first pulses group
10
Second
1-100
1
Pulse A Low
Pressure
Define the minimum vacuum/pressure level in the first pulses
group
130.0
kPa
5-200
1
Pulse A High
Pressure
Define the maximum vacuum/pressure level in the first pulses
group
180.0
kPa
5-200
1
0
#
0-10
1
2
Second
1-100
1
Pulses B Count Define the number of pulses in the second pulses group
Pulse B Stay
Time
Define the additional time that the vacuum pump will continue
to operate or slow/top exhaust valve will remain open after
reaching the preset pressure in the second pulses group
Pulse B Low
Pressure
Define the minimum vacuum/pressure level in the second pulses
group
160.0
kPa
5-200
1
Pulse B High
Pressure
Define the maximum vacuum/pressure level in the second pulses
group
180.0
kPa
5-200
1
Sterilization
Temperature
Define the sterilization temperature
134.0
°C/°F
80-137
0.5°
Sterilization
Time
Define the sterilization time
4.0
Minute
0-9999
0.5
Cool Mode
Defines whether to perform the cooling stage or not. There are 4
options: 0 = no cooling. 1 = forced cooling. 2 = N.A for this
model. 3 = N.A for this model.
0
#
0-3
1
Cool End
Temperature
Define the temperature at the end of the cooling stage
80.0
°C/°F
30-120
1
Cool Exhaust
Rate
Defines exhaust rate at the end of cooling stage
5.0
kPa/sec
1-100
1
exhaust Mode
This parameter enables to choose between FAST EXHAUST=1
to SLOW EXHAUST=2
1
#
1-2
1
Dry heat On 1
Defines the time that the heaters operate during the first drying
period
4
Second
0-120
1
Dry Heat Off 1
Defines the time that the heaters do not operate during the first
drying period
12
Second
0-120
1
Dry First Stage
Time
If steam is produced by heating water in the chamber, it is
possible to define two heating periods during the drying stage.
This parameter defines the first heating period. The second
heating period will begin at the end of the first heating period
and will last until the end of the drying stage.
5
Minute
0-120
1
Dry heat On 2
Defines the time that the heaters operate during the second
drying period
2
Second
0-120
1
Dry Heat Off 2
Defines the time that the heaters do not operate during the
second drying period
20
Second
0-120
1
End
Temperature
Define the temperature at the end of the cycle , the cycle will not
end before reaching the preset temperature
120
°C/°F
30-120
1
Multiple Cycles Define the number of times the cycle repeated
1
#
1-50
1
Multiple Cycles Define the interval between repeated cycles in case that Multiple
Gap
Cycles parameter is defined
2
Minute
1-60
1
Print Rate All
Defines the printing rate during the cycle except sterilization
stage
3
Minute
1-30
1
Print Rate
Sterilization
Defines the printing rate during the sterilization stage
1
Minute
1-30
1
Screen Saver
Defines the interval from the last use of the Keypad until
activating the screen saver
90
Minute
0-600
1
Page 43 of 88 Pages
6.3
Entering the main menu
1. Enter the SELECT USER screen by pressing the UP and
DOWN keys simultaneously.
To exit the SELECT USER screen move the cursor to Exit by
pressing UP or DOWN keys and then press START/STOP key.
2.
3.
4.
5.
6.
SELECT USER screen will be displayed.
Move the cursor to Admin and press START/STOP key. The
following screen will be displayed:
0000 is displayed on the screen with the cursor blinking on the
right digit.
To increase or decrease the digits, press the UP or DOWN keys.
After changing the code to 0001 move the cursor to Set by
pressing the START/STOP key.
When Set is blinking, press the UP or DOWN keys to enter the
MAIN MENU of the autoclave.
The following screen will be displayed:
In order to exit the ENTER CODE screen move the cursor to
Exit by pressing START/STOP Key. when Exit is blinking
press UP or DOWN keys.
Page 44 of 88 Pages
7.
8.
9.
6.4
To browse through the directories, use the UP or DOWN keys.
When the required directory is blinking, press the START/STOP
key. The required screen will be displayed.
In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
Cycle Parameters (Custom 1)
This directory applicable only for custom 1 and custom 2 programs
Subdirectory
Create Pulse
Heat
Sterilization
Cooling
Exhaust
Dry
End
Property
Pulse A Count
Pulse A Stay Time
Pulse A Low Pressure
Pulse A High Pressure
Pulse B Count
Pulse B Stay Time
Pulse B Low Pressure
Pulse B High Pressure
Sterilization Temperature
Sterilization Temperature
Sterilization Time
Cool mode
Cool End Temperature
Cool Exhaust Rate
Exhaust Mode
Dry Heat On 1
Dry Heat Off 1
Dry first stage time
Dry Heat On 2
Dry Heat Off 2
End Temperature
Multiple Cycles
Multiple Cycles Gap
This directory includes seven subdirectories
These subdirectories enable to see and change the cycle parameters.
Therefore it is necessary to choose the required cycle before entering
the "MAIN MENU".
For seeing or changing the parameters proceed as follows:
Choose and enter cycle parameters
The following screen will display:
Page 45 of 88 Pages
6.4.1
Create Pulse
6.4.1.1 Pulse A Count
Typical display for Create Pulse subdirectory
Choose and enter Pulse A Count
SET PARAMETER screen will be displayed
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
6.4.1.2
Pulse A Stay Time
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.3
Pulse A Low Pressure
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.4
Pulse A High Pressure
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.5
Pulse B Count
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.6
Pulse B Stay Time
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.7
Pulse B Low Pressure
Repeat the action mention in 6.2.1.1 Pulse A
Count
6.4.1.8
Pulse B High Pressure
Repeat the action mention in 6.2.1.1 Pulse A
Count
Page 46 of 88 Pages
6.4.2
Heat
6.4.2.1
Sterilization Temperature
Typical display for Sterilization Temperature subdirectory
Choose and enter Sterilization Temperature
SET PARAMETER screen will be displayed
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
6.4.3
Sterilization
6.4.3.1 Sterilization Temperature
See 6.4.2.1 Sterilization Temperature
6.4.3.2
Sterilization Time
Repeat the action mention in 6.2.2.1 Sterilization
Temperature
Page 47 of 88 Pages
6.4.4
Cooling
6.4.4.1 Cool Mode
Typical display for Cool Mode subdirectory
Choose and enter Cool Mode
SET PARAMETER screen will be displayed
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
6.4.5
6.4.4.2
Cool End Temperature
Repeat the action mention in 6.2.4.1 Cool Mode
6.4.4.3
Cool Exhaust Rate
Repeat the action mention in 6.2.4.1 Cool Mode
Exhaust
6.4.5.1 Exhaust Mode
Typical display for Exhaust Mode subdirectory
Choose and enter Exhaust Mode
SET PARAMETER screen will be displayed
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
Page 48 of 88 Pages
6.4.6
Dry
6.4.6.1
Dry Heat On 1
Typical display for Dry Heat On 1 subdirectory
Choose and enter Dry Heat On 1
SET PARAMETER screen will be displayed
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
6.4.7
6.4.6.2
Dry Heat Off 1
Repeat the action mention in 6.2.6.1 Dry Heat On
1
6.4.6.3
Dry first stage time
Repeat the action mention in 6.2.6.1 Dry Heat On
1
6.4.6.4
Dry Heat On 2
Repeat the action mention in 6.2.6.1 Dry Heat On
1
6.4.6.5
Dry Heat Off 2
Repeat the action mention in 6.2.6.1 Dry Heat On
1
End
6.4.7.1
End Temperature
Typical display for End Temperature subdirectory
Choose and enter End Temperature
SET PARAMETER screen will be displayed
Page 49 of 88 Pages
Set the required value, move to Set and press UP
or DOWN keys to confirm the parameter value.
In order to exit move the cursor to Exit and press
UP or DOWN keys
6.5
6.4.7.2
Multiple Cycles
Repeat the action mention in 6.2.7.1 End
Temperature
6.4.7.3
Multiple Cycles Gap
Repeat the action mention in 6.2.7.1 End
Temperature
System Parameters
This directory includes three subdirectories
The following screen will be displayed when entering SYSTEM
PARAMETERS directory:
1.
2.
6.5.1
In order to enter to the sub directories move the cursor by
pressing UP or DOWN keys to the required item and press
START/STOP key
In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
Print Rate All
This subdirectory enables to change the printing rate during
the whole cycle except sterilization stage
Page 50 of 88 Pages
1.
2.
3.
4.
6.5.2
To increase or decrease the digits, press the UP or
DOWN keys.
After changing the value move the cursor to Set by
pressing the START/STOP key.
When Set is blinking, press the UP or DOWN keys in
order to confirm changes and return to the previous
screen.
In order to exit this screen follows one of the next:
 In order to exit this screen move the cursor to Exit
with the START/STOP key and select it by
pressing the UP or DOWN keys.
 Press the UP and DOWN keys simultaneously.
Print Rate Sterilization
This subdirectory enables to change the printing rate during
sterilization stage
1.
2.
3.
4.
To increase or decrease the digits, press the UP or
DOWN keys.
After changing the value move the cursor to Set by
pressing the START/STOP.
When Set is blinking, press the UP or DOWN keys in
order to confirm changes and return to the previous
screen.
In order to exit this screen follows one of the next:
 In order to exit this screen move the cursor to Exit
with the START/STOP key and select it by
pressing the UP or DOWN keys.
 Press the UP and DOWN keys simultaneously.
Page 51 of 88 Pages
6.5.3
Screen Saver
This subdirectory enables the operator to set the screen
saver time.
The default time value is 90 minutes. It is possible to
increase or decrease the time value up to a maximum of 600
minutes or down to a minimum 0 minutes.
When entering the Screen Saver screen, the time will be
displayed. The cursor is blinking on the "minute" digit.
The time is displayed in the form “0000” min.
1.
2.
3.
4.
6.6
To increase or decrease the digits, press the UP or
DOWN keys.
After changing the value move the cursor to Set by
pressing the START/STOP.
When Set is blinking, press the UP or DOWN keys in
order to confirm changes and return to the previous
screen.
In order to exit this screen follows one of the next:
 In order to exit this screen move the cursor to Exit
with the START/STOP key and select it by pressing
the UP or DOWN keys.
 Press the UP and DOWN keys simultaneously.
History
This directory includes two subdirectories
The following screen will be displayed when entering HISTORY
directory:
1. In order to enter to the sub directories move the cursor by pressing
UP or DOWN keys to the required item and press START/STOP
key
Page 52 of 88 Pages
2. In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
6.6.1
View old cycle history
This subdirectory enables to print the 100 previous cycles.
The following screen will be displayed when entering View
old cycle history subdirectory:
1.
6.6.2
Choose the required cycle according to cycle number,
date and time with the UP or DOWN keys
2. Press the START/STOP key. The printer will print the
printout of the required cycle
3. In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN
keys and select it by pressing the START/STOP
key.
 Press the UP and DOWN keys simultaneously.

Export history to USB
This subdirectory enables to Export history to USB device.
1.
2.
3.
4.
Insert the USB device into the USB Socket
Move the cursor to Export history to USB
Press the START/STOP key.
The following screen will be displayed:
5.
Move the cursor to the required item and press
START/STOP key
The following screen will be displayed:
6.
Page 53 of 88 Pages
7.
8.
9.
6.7
Remove the USB device from the USB Socket
In order to exit this screen and return to HISTORY
OPTIONS screen press START/STOP key.
In order to exit the HISTORY OPTIONS screen
follows one of the next:
 Move the cursor to Exit with the UP or DOWN
keys and select it by pressing the START/STOP
key.
 Press the UP and DOWN keys simultaneously.
Maintenance
This directory includes four subdirectories
The following screen will be displayed
MAINTENANCE directory:
when
entering
1. In order to enter to the sub directories move the cursor by pressing
UP or DOWN keys to the required item and press START/STOP
key
2. In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
Page 54 of 88 Pages
6.7.1
Set date and time
This subdirectory enables the operator to set the date and
time.
This SET DATE AND TIME screen will be displayed
when entering the subdirectory:
When entering the SET DATE AND TIME screen, the
time and date are displayed. The cursor is blinking on the
"second" digit.
The time is displayed in the upper row in the form
"HH:MM:SS". The hour range is 24 hour (i.e. from "0" to
"24")
The date is displayed in the lower row in the form
"DD:MMM:YYYY".
1.
To increase or decrease the time or the date use the UP
or DOWN keys.
2.
To move the cursor from one digit to another press the
START/STOP key.
3.
After changing the time and the date move the cursor
to Set.
4.
Confirm the new time and date by pressing UP or
DOWN keys.
After saving is completed, SET DATE AND TIME
screen is still displayed, move the cursor to Exit and
press UP or DOWN keys to return to
MAINTENANCE screen.
Export gain offset to USB
5.
6.7.2
This subdirectory enables to Export gain offset to USB
device.
1.
2.
3.
4.
Insert the USB device into the USB Socket
Move the cursor to Export gain offset to USB
Press the START/STOP key
The following screen will be displayed:
Page 55 of 88 Pages
6.7.3
5.
6.
Remove the USB device from the USB Socket
In order to exit this screen and return to
MAINTENANCE directory press START/STOP key.
7.
In order to exit the MAINTENANCE directory follows
one of the next:
 Move the cursor to Exit with the UP or DOWN
keys and select it by pressing the START/STOP
key.
 Press the UP and DOWN keys simultaneously.
Print Test
This subdirectory enables the operator to test the printer.
When pressing START/STOP key on the Printer Test item
the printer will print out the following print out:
Cycle errors:
None
Canceled By User
Door is open
Analog Input Error
I/O Card Failed
Power Down
Invalid Parameter Value
No Water
Heat Time Error
Vacuum Time Error
Pressure Time Error
Heat Time Error (Keep)
Heat Time Error
Low Pressure
High Pressure
Low Temp
High Temp
Time Error
Low Pressure (Cooling)
High Temp. (Cooling)
High Pressure (Exhaust)
High Pressure (Dry)
High Pressure (Ending)
Air Error
High Temp. (Ending)
Error Open Door
Error Close Door
Accessory Timeout
And the following screen will be displayed.
Page 56 of 88 Pages
In order to exit this screen and return to MAINTENANCE
directory press START/STOP key.
In order to exit the MAINTENANCE directory follows one
of the next:
 Move the cursor to Exit with the UP or DOWN keys
and select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously
6.7.4
Print All Gain and Offset
This subdirectory enables the operator to print all the gain
and offset values.
When pressing START/STOP key on the Print all gain
and offset item the printer will print out the following:
Drain Temperature
G:000.0400;O:-004.0000
Chamber Temperature
G:000.0400;O:-004.0000
Ref Temperature 1
G:000.0400;O:-004.0000
Chamber Pressure
G:000.1250;O:-100.0000
And the following screen will be displayed.
In order to exit this screen and return to MAINTENANCE
directory press START/STOP key.
In order to exit the MAINTENANCE directory follows one
of the next:
Page 57 of 88 Pages

6.8
Move the cursor to Exit with the UP or DOWN keys
and select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously
Advanced Options
This directory includes two subdirectories
The following screen will be displayed when entering ADVANCED
OPTIONS directory:
1. In order to enter to the sub directories move the cursor by pressing
UP or DOWN keys to the required item and press START/STOP
key
2. In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
6.8.1
Start Cycle by Clock
This subdirectory enables the operator to postpone the
operation by a pre-set time.
This Start cycle by clock screen will be displayed when
entering the START CYCLE BY CLOCK subdirectory:
When entering the START CYCLE BY CLOCK screen,
the time is displayed. The cursor is blinking on the "minute"
digit.
The time is displayed in the form “HH:MM”. The hour
range is 24 hours (i.e. from "0" to "24").
Page 58 of 88 Pages
Enabling the START CYCLE BY CLOCK
1.
2.
3.
4.
5.
To increase or decrease the time use the UP or DOWN
keys.
To move the cursor from one digit to another press the
START/STOP key.
After changing the time move the cursor to Enabled
Confirm the START CYCLE BY CLOCK by
pressing UP or DOWN keys.
Move the cursor by pressing START/STOP key to
Exit and press UP or DOWN keys to return to
ADVANCED OPTIONS screen.
Canceling the START CYCLE BY CLOCK
1.
2.
To cancel the START CYCLE BY CLOCK move the
cursor by pressing START/STOP key to Disable and
press UP or DOWN keys.
Move the cursor to EXIT by pressing START/STOP
key and press UP or DOWN keys, the START
CYCLE BY CLOCK will be canceled.
Page 59 of 88 Pages
6.8.2
Export all settings to USB device
This subdirectory enables the operator to export all settings
to USB device.
1.
2.
3.
4.
Insert the USB device into the USB Socket
Move the cursor to Export all settings to USB device
Press the START/STOP key.
The following screen will be displayed:
5. Remove the USB device from the USB Socket
6. In order to exit this screen and return to ADVENCED
OPTIONS directory press START/STOP key.
In order to exit from the ADVANCED OPTIONS directory
follows one of the next:
 Move the cursor to EXIT with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously
6.9
Version information
This directory includes two subdirectories
The following screen will be displayed when entering VERSION
INFORMATION directory:
1. In order to enter to the sub directories move the cursor by pressing
UP or DOWN keys to the required item and press START/STOP
key
2. In order to exit this screen follows one of the next:
 Move the cursor to Exit with the UP or DOWN keys and
select it by pressing the START/STOP key.
 Press the UP and DOWN keys simultaneously.
Page 60 of 88 Pages
6.9.1
View current version information
In order to view this subdirectory press
START/STOP key on the View current version
information item.
This subdirectory enables the operator to see the
current version information as described below:
1.
GUI
2.
Software
3.
Data
4.
Utilities –
the
to
5.
OS
Graphic user interface – Holds the entire
Human Machine interface including the
main
application screen and all the
configuration screens, which enable the
user to handle the
machine.
Logic – Holds all the application logic for
running the machine.
Code section that handle the entire data
storage in the application.
Utilities – Holds general functionality
which is used by the logic section and
GUI
section e.g: converting function
display different pressure or temperature
units , languages types etc.
Operational System – Microsoft Windows
CE. Version 6.0.
Major
change
Minor
change

Major change

Minor change
change,

sequence.
Bugs repair
Automatic
builder
Bugs
repair
DLL size
Software
update date
Concept change eg: changing the
operating system, Changed by the
programmer in accordance with
the change sequence.
Feature change or function
changed by the programmer in
accordance with the change
Software bugs repair changed by
the programmer in accordance
with the change sequence.
Page 61 of 88 Pages


6.9.2
Automatic builder Changed (updated) automatically
after
each
source
code
compilation
DLL size
Dynamic-Link Library size
View factory default version information
This subdirectory enables the operator to see the
factory default version information.
In order to see this subdirectory press START/STOP
key on the View factory default version
information item.
The following screen will be displayed:
Major
change
6.9.3
Minor
change
Bugs
repair
Automatic
builder
DLL size
View previous version information
This subdirectory enables the operator to see the
previous version information.
In order to see this subdirectory press START/STOP
key on the View previous version information item.
Page 62 of 88 Pages
Software
update date
7.
SCREENS
7.1
Screens following a complete successfully cycle – "Cycle Ended"
1. System Ready
2. Insert Water
3. Heat
4. Sterilization
5. Exhaust
6. Ending
7. Cycle Ended
7.2
Screens following aborted cycles after complete sterilization stage
The sterilization phase ended successfully – cycle ended and the
reason of failure is displayed
For example the next two scenarios:
7.2.1
Canceled by user after complete sterilization stage
The cycle ended successfully, the reason for aborted cycle is
displayed.
7.2.2
Pressure Time Error Failure occurrence after complete
sterilization stage
The cycle ended successfully, the reason of failure is
displayed.
Page 63 of 88 Pages
7.3
Screens following a fail cycle:
In this case, the display becomes yellow, a warning sign
of failure will be displayed.
and the reason
For example, the next two scenarios:
7.3.1
Failure according to Pressure Time Error
7.3.2
Failure according to Cancellation by user before complete
sterilization stage
When "Cycle Failed" appears on the screen, the user shall
press START/STOP key in order to delete the "Cycle
Failed" message
An example for all displayed warnings according to Cycle Failed:
Cycle Failed message
Reason of failure
The screen colour changed
from white to yellow
Warning symbol
Page 64 of 88 Pages
8.
PRINTER
8.1
Printer Output
The printing is on thermal paper with 24 characters per line and
contains the following information:










Date:
Time:
Ser. Num:
Model:
Version:
Cycle Num:
Cycle:
Dry Time:
Ster Temp:
Ster Time:
When the sterilization cycle begins the printer starts printing the above
data.
After the preliminary printing, the autoclave starts performing the
sequence of operations of the cycle. The measured values of
temperature and pressure are printed at fixed time intervals, according
to the phase of the process, as shown in the table on the next page.
The data is printed from the bottom up, beginning with the date and
ending with "Cycle Ended". For an aborted cycle, "Cycle Failed" and
the Error message are printed (refer to "Displayed Error
Messages/Symbols").
For an example of a typical printout, see next page.
Page 65 of 88 Pages
PRINTER OUTPUT
Operator:
____________
Time:
12:14:47
Cycle Ended
00:24:43
101.3
099.7
E 00:23:43
107.0
107.4
E 00:22:08
134.5
311.9
CLK 2:
12:12:10:00
CLK 1:
12:12:10:00
S 00:22:07
134.5
311.6
S 00:22:06
134.5
311.6
S 00:21:06
134.6
311.0
S 00:20:06
134.5
310.1
S 00:19:06
134.8
311.1
S 00:18:06
134.5
315.8
CLK 2:
12:08:08:00
CLK 1:
12:08:08:00
H 00:18:04
134.4
315.1
H 00:16:35
128.9
268.4
H 00:13:35
116.3
180.9
A 00:11:04
107.0
120.9
A 00:10:22
115.1
180.4
A 00:10:00
113.7
170.5
A 00:07:00
098.7
101.5
A 00:06:45
097.6
101.4
A 00:03:45
080.2
099.4
A 00:00:45
053.7
099.4
A 00:00:04
046.5
100.0
TIME
°C
kPa
Ster Time:
4.0min
Ster Temp:
134.0°C
Cycle:
Unwrapped instru
Cycle Num:
000001
Version:
7.0.00.00
Model:
Ser. Num:
Time:
Date:
----------------------Time:
Date:
POWER ON
Time:
Date:
POWER OFF
3870ELVC
000000000001
11:50:05
9/FEB/2010
08:51:39
9/FEB/2010
00:00:00
9/FEB/2010
DESCRIPTION
To be filled in manually by operator
Time sterilization cycle ended
Cycle finished time
The time, temperature and pressure during exhaust
The time, temperature and pressure during exhaust
The time, temperature and pressure during sterilization
The time, temperature and pressure during sterilization
The time, temperature and pressure during sterilization
The time, temperature and pressure during sterilization
The time, temperature and pressure during sterilization
The time, temperature and pressure during sterilization
The time, temperature and pressure during heating
The time, temperature and pressure during heating
The time, temperature and pressure during heating
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
The time, temperature and pressure during Air removal
Sterilization time for selected program
Sterilization temperature in chamber for selected program
Cycle name
Cycle number
Software version A.B.CC.DD = 7.0.00.00
A: Door Type: Single motor = 7
B: Vacuum Type = 0
C: Total number of Input/Output functionality that are not as default = 00
D: Total number of parameters values that are not as default = 00
Model name
Model Serial number
Time sterilization cycle started
Date sterilization cycle started
Time of turning on
Date of turning on
The device is turned on
Time of turning off
Date of turning off
The device is turned off
Legend
A
H
S
C
Air removal stage (Steam flash)
Heating stage
Sterilization stage
Cooling stage (for ELVC only)
E
Exhaust stage
CLK 1
CLK 2
Real Time Clock
Software clock
Page 66 of 88 Pages
8.2
Printer Handling
8.2.1
Maintenance
Wipe off the soiling on the printer surface with a dry soft
cloth with a weak neutral detergent. After that, wipe the
printer with a dry cloth.
8.2.2
Setting paper
PLUS II Front view
1-Paper mouth
2-STATUS Led
3-OPEN key (for paper roll compartment
opening)
4-FEED key
5-Paper roll compartment
6-Paper end sensor
Fig. 1
Fig. 1
Page 67 of 88 Pages
1.
Open the printer's cover door (1) by pulling it up (see Fig.
2).
1
2
Fig. 2
2.
Press the OPEN key to open the printer cover as shown
(see Fig. 3/1). Handle the paper cutter carefully not to
cut your hand.
3.
Place the paper roll making sure it unrolls in the proper
direction as shown (see Fig. 3/2).
4.
Take out the paper and re-close the cover as shown (see
Fig. 3/3) the printer cover is locked.
5.
Tear off the exceeding paper using the jagged edge (see
Fig. 3/4).
Fig. 3
6.
Close the printer's cover door (1) by pulling it down, with
the tip end of the paper emerging from the slot (2) (see
Fig. 2).
Page 68 of 88 Pages
8.2.3
Treating the thermal papers:
 Store the papers in a dry, cool and dark place.
 Do not rub the papers with hard substance.
 Keep the papers away from organic solvent.

Cautions
Never disassemble the printer. Failure to follow this
instruction may cause overheating or burning of the
printer or the AC adapter. Or an electric shock, which
may lead to fires or accidents.
Never use the printer in a place of extreme humidity or
any place where it can possibly be splashed by any
liquids. If any liquids get into the printer, it could lead to
fire, electric shock, or other serious accidents.
Never touch the thermal head immediately after printing
because it becomes very hot. Make sure that the thermal
head is cool before setting papers or cleaning the thermal
head.
Power OFF the printer in any of the following cases:
 The printer does not recover from an error.
 Smoke, strange noise or smells erupt from the printer.
 A piece of metal or any liquid touches the internal parts
or slot of the printer.
Page 69 of 88 Pages
9.
PREPARATION BEFORE STERILIZATION
The purpose of packaging and wrapping of items for sterilization is to provide
an effective barrier against sources of potential contamination in order to
maintain sterility and to permit aseptic removal of the contents of the pack.
Packaging and wrapping materials should permit the removal of air from the
pack, penetration of the sterilizing water vapor into the pack and removal of
the sterilizing vapor.
The basic principle determining the size, mass and contents of instrument and
hollowware packs is that the contents are sterile and dry immediately on
completion of the drying cycle and removal of the pack from the sterilizer
chamber.
Instruments to be sterilized must be clean, free from any residual matter, such
as debris, blood, pads or any other material. Such substances may cause
damage to the contents being sterilized and to the sterilizer.
9.1
1.
Immediately after use, clean instruments thoroughly to dispose of any
residue.
2.
Follow the instrument manufacturer instructions.
3.
It is recommended to wash instruments with an ultrasonic cleaner, using
detergent and mineral-free water.
4.
Launder textile wraps prior to reuse.
5.
After cleaning, rinse instruments for 30 seconds. (Follow manufacturer’s
instructions on the use of products for cleaning and lubricating
instruments after using the ultrasonic cleaner).
6.
Materials, including materials used for inner wraps, shall be compatible
with the item being packed and the sterilizing method selected.
7.
Use single-use wraps once only and discard after use.
8.
If the unit is equipped with a printer, verify if a new roll of paper is
necessary.
Instruments
1. Before placing an instrument onto the sterilizer baskets, ensure that
instruments that are not constructed of the same metal (stainless
steel, carbon steel, etc.) are separated and placed in a different place.
2.
Place empty containers upside down to prevent accumulation of
water.
3.
In case carbon steel instruments are placed in stainless steel baskets,
the baskets should be lined with a towel or paper wrap before
placing the instruments on the baskets. There should be no direct
contact between the carbon steel and the stainless steel baskets.
4.
All instruments must be sterilized in an open position.
5.
Place a sterilization indicator strip in each basket.
6.
Place instruments with ratchets opened and unlocked or clipped on
the first ratchet position.
7.
Disassemble or sufficiently loosen multiple-part instruments prior to
packaging to permit the sterilizing agent to come into contact with
all parts of the instrument.
Page 70 of 88 Pages
8.
Tilt on edge items prone to entrap air and moisture, e.g. hollowware,
so that only minimal resistance to removal of air, the passage of
steam and condensate will be met.
9.
Once a week, use a biological spore test indicator in any load to
make sure sterilization is performed.
10. Make sure that all instruments remain apart during the sterilization
cycle.
11. Load the basket loosely to capacity.
9.2
Liquids
1. Use only heat- proof glass containers, filled to 2/3 capacity.
2. For Slow exhaust cooling (without air) the glass container should
be covered but unsealed.
3. Place the two temperature sensors into two separate liquid
containers. These are used to control the program temperature and
ensure the safety of the operating cycle.
9.3
Loading
The loading of goods and instruments is done by means of two stacked
baskets. The baskets are provided with handles for the convenience of
the operator.
There are 2 types of baskets:
1. Baskets that are fully perforated.
2.
Baskets that are not perforated except one row of holes adjacent to
the basket’s top. These baskets are intended for waste cycles, to
avoid clogging of the vessel’s drainage pipe by overflowing
liquids.
Page 71 of 88 Pages
10.
OPERATION
10.1
Filling the water reservoir (WR configuration only)
Remove the water reservoir cover (See Rear view, WR Configuration).
Pour distilled water into the reservoir until it reaches the cooling coil
(see the figure below). The water quantity is approx. 28 liters (7.4 US
gal.).
1
Use only water having the characteristics as per table in sec 3.11.1 Tap
water may clog the system. A clogged system causes increase of
pressure, which prevent temperature from rising.
Caution!
Under no circumstance should water be filled above the cooling coil.
Drain the water from the mineral free water reservoir once a week,
and refill with fresh mineral-free water or distilled water
10.2
Turning on the autoclave
 To start the system, turn on the main switch (1), located under the
printer cover.
1
The door is equipped with an electrical cylinder. This electrical
cylinder perform the automatic opening and closing of the door.
Page 72 of 88 Pages
10.3
Opening the door
In order to open the door, follow the next steps:
When the door is closed the screen below will be displayed:
Press the
Key in order to open the door
The following screen will be displayed:
If the door has opened successfully, the following screen will be
displayed:
10.4
Loading
 Load the autoclave properly according to instructions in sec. 9.
PREPARATION BEFORE STERILIZATION.
 Select the program.
 UP key: next program.
 DOWN key: previous program.
 Verify that you chose the required program.
Page 73 of 88 Pages
10.5
Closing the door
In order to close the door, follow the next steps:
When the door is open, the screen below will be displayed:
In order to close the door push the door to the wall of the autoclave
chamber for at least 5 seconds as shown in the picture below:
While closing the door the following screen will be displayed:
When the door is properly closed, open door symbol
is
replaced by the message "System Ready" and the following screen
will be displayed:
Page 74 of 88 Pages
10.6
Starting cycle
Start the cycle by pressing the START/STOP key.
If your autoclave supports CFR 21 part 11 standard,
perform the following procedure:
SELECT USER screen will be displayed:
1.
Enter the Enter Code screen by moving the cursor to
your username (Use Up and Down keys) and pressing
START/STOP key. The following screen will be
displayed:
2.
0000 is displayed on the screen with the cursor
blinking on the right digit.
3.
To increase or decrease the digits, press the UP or
DOWN keys.
4.
Set your password, then move the cursor to
Set by pressing the START/STOP key.
5.
When Set is blinking, press the UP or DOWN
keys to return to the program screen.
Page 75 of 88 Pages
10.7
Unloading
When the cycle ended successfully (including pressing the
START/STOP key, or any failure, after completing the sterilization
stage) message "Cycle Ended" (and the relevant failure message, if
applicable) is displayed on the screen.
 Verify that there is no pressure in the chamber, according to the
reading on the display. Only than you may open the door.
 Open the autoclave. (see sec. 10.3 Opening the door)
Warning
To avoid sever injuries from hot steam when opening the door:
 It is strictly forbidden to lean on the autoclave.
 It is strictly forbidden to place your hand or any part of
your body over the door.
 Since the autoclave is defined as a bio-hazard autoclave, a
failed cycle may leave un-sterilized waste in the chamber.
Therefore failed cycle will be followed by a slow exhaust and
the door will remain locked. To enable opening the door
perform a new cycle. The door can be opened only after a
successful cycle.
 Wear heat-resistant gloves or use the tray handle to remove the
load from the autoclave
 On completion of the cycle, the load shall be visual inspected to
ascertain that the load is dry, and that the colour of the sterilization
indicators turned to the required colour.
10.8
Stopping the process and cancelling the ERROR message
 It is possible to stop the program while the autoclave is operating.
Pressing the START/STOP key at any stage of the process stops
the operation. If the cycle was aborted before completing the
sterilization stage, it will leave the load unsterilized.
 At the end of the aborted process (before completing the
sterilization stage), "Cycle Failed" message, error message and a
warning symbol
are displayed on the screen. Refer to
"Displayed Error Messages/Symbols".
 Pressing the START/STOP key cancels the displayed message
and enables opening the door.
If the door is not opened, the vacuum pump will stop automatically
after 30 minutes.
Warning
The load has not completed a sterilization cycle, therefore it is not
sterile. Handle it as contaminated load.
10.9
Start Cycle by Clock mode
 This mode enables the operator to define the time of the beginning
of the cycle. The maximum possible delay is 24 hours. For further
information see sec. 6.8.1. “Start Cycle by Clock”.
Page 76 of 88 Pages
10.10
Moving the Autoclave
1. Disconnect the power supply cord.
2. Disconnect the water and drain hoses.
3. Disconnect the compressed air hoses (if applicable).
4. Drain the water from the chamber.
To avoid injuries, Moving the autoclave should be done by using a
forklift.
Caution:
Before moving the autoclave, verify that the electrical, air and
water connections have been disconnected, and there is no pressure
in the chamber.
Do not drop this device!
10.11
Loading and Unloading the Device
10.11.1
Safety
Protective equipment and clothes and other safety
instructions should be implemented in accordance with local
and national regulations and/or rules!
For proper sterilization - Do not overload the chamber. Only
autoclavable products shall be used; please refer to the
manufacturer instructions for sterilization of unknown
materials or instruments.
10.11.2
Loading
Correct loading of the autoclave is essential to successful
sterilizing for several reasons. Efficient air removal from the
chamber and the load will permit effective steam penetration
and saturation, and allow proper drainage of condensate.
Additionally, correct loading will prevent damage to packs
and their contents and maximize efficient use of the
sterilizer.
For detailed loading instructions, see sec. 9 (Preparation
before sterilization)
10.11.3
Unloading
On completion of the cycle, take out the load immediately
from the sterilizer. Do not remove the load from the basket
until its temperature reduces to the room temperature. Let the
load cool down in an area without air movement (air
conditioning, etc.) and with minimum people passing by to
avoid possibility of touching the hot load. Do not touch the
hot load since hot load absorbs moister and, therefor, may
absorb bacteria from your hand. Do not transfer hot load to
metal shelves for cooling. Perform a visual inspection to
ascertain that sterilizing indicators have made the required
colour change, and that the load is dry.
The load shall be rejected if:
a. The package has been compressed.
b. The package is torn.
c. The load is suspected to be wet.
Page 77 of 88 Pages
d.
e.
The load fell on the floor.
Condensed drops can be detected on the load.
To avoid injuries use heat resistant gloves while unloading
the autoclave.
11.
DOOR SAFETY SYSTEM
The door safety consists of two safety means:
11.1
Electric door locking system
Door closing: the user pushes the door towards the chamber frame, a
switch located on the frame indicates that the door is in locking position
and switches on an electrical cylinder that closes and locks the door. Two
micro switches indicate that the door is locked, and stops the command to
the electrical cylinder.
Door opening: The user presses a key to open the door. The control
system operates the electrical cylinder that unlocks the door. When the
door is unlocked, a micro switch indicates that the door is unlocked and
stops the electrical cylinder.
11.2
Pressure switch
The autoclave is equipped with a NC 10 kPa (1.4 psi) pressure switch that
is connected to the chamber. When the pressure switch senses pressure of
10 kPag (1.4 psig) it disconnects the electrical command of the electrical
cylinder to avoid accidental opening of the door.
Page 78 of 88 Pages
12.
SERVICE AND MAINTENANCE
12.1
Preventive Maintenance
The maintenance operations described in this chapter must be fulfilled
periodically in order to keep the autoclave in good working condition and
to reduce the breakdown time to a minimum.
The user’s maintenance personnel, according to the following instructions
can easily execute these operations.
The owner of the autoclave is responsible to order an authorized
technician to perform the periodical tests and preventive maintenance
operations, as specified in the technician manual.
Use only mineral-free water as detailed in sec. 3.11 (water quality).
Warning
Before carrying out any preventive maintenance operation, ensure that
the electrical cord is disconnected and there is no pressure in the
autoclave.
12.1.1
Daily
Clean the door gasket with a soft cloth. The gasket should be
clean and smooth.
12.1.2
Weekly
1. Remove the baskets (if applicable). Clean the chamber and
baskets with a cleaning agent & water and with a cloth
sponge. You may use diluted Chamber Brite™ solution as
cleaning agent. To prepare this solution, pour one bag of
Chamber Brite™ into 3/4 – 1 liter of warm mineral-free
water. Immediately after cleaning, rinse the baskets and the
chamber's interior with water to avoid stains on the metal.
Caution
Do not use steel wool or steel brush as this can damage
the chamber!
12.1.3
2.
Drain out the vessel and clean the electrode with a soft
cloth.
3.
Drain the water from the mineral free water reservoir once
a week, and refill with fresh mineral-free water or distilled
water (see sec. 12.3).
4.
Put a few drops of oil on the two door pins and door
tightening bolts.
5.
Clean outer parts of the autoclave with a soft cloth.
Periodically by Qualified Technician
For the BH – bio-hazard models, every 1 month, or if the
cycle fails because of "low-heat", sterilize and clean the
bio-hazard filter.
2. For the BH – bio-hazard models, every 100 cycles replace
the bio-hazard filter.
1. Every 6 months replace the air filter, (if installed) (to be
done by an authorized technician).
2.
Once a year check and tighten the piping joints to avoid
leakage (to be done by an authorized technician).
Page 79 of 88 Pages
1. Checking the water reservoir, piping, plastic parts and
electric wires.
3. Once a year check and tighten all screw connections in the
control box, heaters, valves and instrumentation (to be done
by an authorized technician).
12.1.4
12.2
Periodical Tests
1. Once every month activate the safety valve (see sec. 12.2).
Checking the Safety Valve
The safety valve is located on the rear side of the autoclave
In order to prevent the safety valve from a blockage, operate it once a
month.
12.2.1
PED-approved type safety valve
Operate the sterilization cycle according to the manual.
Allow a pressure of approximately 200 kPa (29 psi) to build
up in the chamber.
Turn the safety valve pressure-regulating nut clockwise for 2
seconds. Be careful not to burn your hands.
Return the nut to its original position.
Press the STOP/STOP key to interrupt the operation, and
exhaust steam from chamber.
Wait until the pressure decreases to zero, only then can the
door be opened.
Attention:
Use protective gloves in order not to burn your hands with the
hot steam.
Pressure-Regulating Nut
Rear Wall
Page 80 of 88 Pages
12.2.2
ASME-approved type safety valve
Operate the sterilization cycle according to the manual.
Allow a pressure of approximately 200 kPa (29-psi) to build
up in the chamber.
Operate the safety valve by pulling the ring of the safety
valve using a tool, i.e. screwdriver, hook etc and lift the
safety valve ring for 2 seconds. Be careful not to burn your
hands.
Press the STOP/STOP key to interrupt the operation, and
exhaust steam from chamber.
Wait until pressure goes down to zero, only then can the
door be opened.
Attention:
Use protective gloves in order not to burn your hands with
the hot steam.
Safety valve ring
12.3
Draining the Reservoir
CAUTION!
Before starting, Make sure that the electric cord is disconnected
and there is no pressure in the autoclave.
The drain valve is located on the bottom of the water reservoir (See
REAR VIEW (WR CONFIGURATION). The function of the drain
valve is to drain the water reservoir.
To drain the reservoir into a bucket:
1.
Open the drain valve.
2.
Fully drain the reservoir.
Page 81 of 88 Pages
3.
Close the drain valve.
4.
Connect the electric cord to power source.
5.
Fill the reservoir with distilled water to just below the cooling coil
(see sec. 10.1).
6.
Turn on the main power switch.
The autoclave is now ready for use.
Page 82 of 88 Pages
13.
TROUBLESHOOTING
This troubleshooting chart enables the user to solve minor malfunctions,
prior to contacting our service department.
Only technical personnel having proper qualifications and holding
technical documentation (including a technician manual) and adequate
information are authorized to service the apparatus.
Message /
Symbol /
Problem
Failure Description
Corrective Action
1 The main switch is in ‘OFF’
position.
1 Turn the main switch to
the ‘On’ position.
(see front view drawing).
2 The power cord is disconnected 2 Make sure the power cord
The machine
from the machine or the mains.
is connected properly to
is not
the machine and the
responding
mains.
3 The circuit breaker has tripped.
(see rear view drawing)
3 Lift the circuit breaker
lever.
1 The Paper roll is not installed in 1 Install the paper roll in
The printer
the right way.
the right way. Only one
prints, but
(see sec. 8.2, Printer handling)
side of the paper is
nothing is
printable.
printed on the
(see sec. 8.2, Printer
paper.
handling)
1 No paper is inserted in the
1 Make sure the paper roll
printer.
is inserted in the printer.
(see sec. 8.2, Printer handling)
(see sec. 8.2, Printer
The printer
handling)
does not print.
2 No obvious reason.
2 Switch off the machine
and switch it back on for
restart
1 The door gasket is dirty.
1 Clean the door gasket.
The machine
(see sec. 12.1.1, daily
(see sec. 12.1.1, daily
is leaking at
maintenance)
maintenance).
the door
2 The door gasket is damaged.
2 call for service.
1 Perform a new cycle.
Message is displayed and FAIL
indicator lights if in the air
2 Call the technician.
removal stage a vacuum level of 3 The bio-hazard filter may
15kPa is not reached during
be clogged. Since the
Low Vacuum’
20minutes after the cycle is
door cannot be opened
is displayed
started
until a complete
successful cycle is
completed – call for
technical service.
Low Temp
High Temp
This message is displayed if the
temperature drops for more than 1
second below the sterilization
temperature during sterilization
cycle.
This message is displayed if the
temperature raises 7°F (4°C) above
Page 83 of 88 Pages
Perform a new cycle.
Perform a new cycle.
Message /
Symbol /
Problem
Failure Description
Corrective Action
sterilization temperature during the
sterilization stage for 2 seconds
during sterilization cycle.
This message is displayed if the
High Temp.
system cannot reach the required
Perform a new cycle.
(Ending)
temperature, in the chamber, within
10 minutes.
This message is displayed if the
High Temp.
system cannot reach the required
Check and fix the city (tap)
(Cooling)
temperature, in the cooling stage,
water supply.
within preset time.
This message is displayed if the
Heat Time
system cannot reach the required
Verify that the autoclave is
Error
temperature, in the chamber, within not overloaded.
the preset time.
This message is displayed if the
system cannot reach the required
Heat Time
Verify that the autoclave is
temperature, in the chamber, during
Error (Keep)
not overloaded.
the optional "Keep Heat" stage,
within the preset time.
This message is displayed if
Chamber Pressure drops below the
Low Pressure sterilization pressure (134°C = 304 Perform a new cycle.
kPa, 121°C = 205 kPa) for 2 seconds
during the sterilization stage.
This message is displayed if the
Low Pressure pressure in chamber does not reach Check and fix the compressed
(Cooling)
the preset pressure before initiating air supply.
the cooling stage.
This message is displayed if
Chamber Pressure raises 4.2 psi-29
High
kPa above sterilization pressure
Perform a new cycle.
Pressure
(134°C = 304 kPa, 121°C = 205 kPa)
for 2 seconds during the sterilization
stage.
This message is displayed if the
High
system cannot reach atmospheric
Pressure
Perform a new cycle.
pressure ± 10kPa during the ending
(Ending)
stage.
This message is displayed if the
High
system cannot reach preset pressure
Pressure
Perform a new cycle.
within 10 minutes from the beginning
(Exhaust)
of the exhaust stage.
This message is displayed if the
system cannot reach the required
Pressure Time
Verify that the autoclave is
pressure conditions in the chamber,
Error
not overloaded.
after preset time, during the air
removal stage.
RTC Error Set Current Date And Time.
Please Set
This message is displayed in order
If the problem persists, call
Current Date to set the date and the time.
the technician.
and Time
Page 84 of 88 Pages
Message /
Symbol /
Problem
Failure Description
Time Error
This message is displayed if the
real time clock is faulty.
Door is open
(During the
cycle)
This message is displayed when the
door is open: During the cycle.
Canceled By
User
Cycle Failed
Air Error
Compressed
air supply
error
Periodical
check time
exceeded Please call
for service
"Supplied
Distilled
Water Error".
Cycle counter
exceeded Please call for
service
Power Down
Supply
distilled
water error
(digitat input
option)
Supply water
error (digitat
input option)
Compressed
air supply
error (digitat
input option)
No Water
Corrective Action
Call the technician.
Close the door to perform a
new cycle.
This message is displayed after the
START/STOP key is pressed and
cycle aborted.
Wait until "cycle failed –
canceled by user" or "cycle
end – canceled by user" is
displayed.
Perform a new cycle.
This message and symbol are
displayed if an error occurs before
sterilization cycle is completed.
Perform a new cycle.
This message is displayed at the
end of the cycle If the autoclave
does not reach the atmospheric
pressure after 10 minutes.
This message is displayed in case
of a compressed air supply
malfunction.
Wait until the autoclave
reaches the atmospheric
pressure and perform a new
cycle.
Check and fix the
compressed air supply.
The periodical maintenance time
has passed.
Call for service.
Mineral free water reservoir
empty"
Fill the mineral free water
reservoir.
Number of cycles, since last
periodical maintenance, exceeded
the preset number as defined by
"cycle counter" parameter.
This message is displayed if power
down has occurred during the
cycle. (this message will print out
in the printer after the autoclave
will turn on).
Call for service.
Turn on the autoclave and
wait until the autoclave is
ready (reaches the safe
condition) and perform a
new cycle.
This message is displayed in case
of a mineral free water supply
malfunction.
Check and fix the mineral
free water supply
This message is displayed in case
of a city (tap) water supply
malfunction.
Check and fix the city (tap)
water supply.
This message is displayed in case
of a compressed air supply
malfunction.
Check and fix the air supply.
This message is displayed if the
electrode in the chamber did not
1. check and fix the mineral
free water supply.
Page 85 of 88 Pages
Message /
Symbol /
Problem
Failure Description
Corrective Action
sense water within the preset time.
2.check and clean the water
inlet filter.
3. Clean the water level
electrode.
Analog Input
Error
This message is displayed when any
Temperature sensor or Pressure
sensor is disconnected or out of
range.
Call for service.
Chamber
temperature
not in range
This message is displayed if the
temperature in the chamber is too
high or too low from the normal
range.
Call for service.
This message is displayed if the
Chamber
pressure not in pressure in the chamber is too high or Call for service.
too low from the normal range.
range
This message is displayed if I/O
I/O Card Failed card is faulty (both while cycle is
Call for service.
running or not).
I/O card is
This message is displayed if I/O
not
card is disconnected (both while
Call for service.
connected
cycle is running or not).
Page 86 of 88 Pages
BASKETS AND CONTAINERS
Container for waste products
Type
High Basket
Stainless steel wire baskets
Low Basket
Stainless steel container for waste
products, with vent holes
Dia. x Height (mm)
Capacity
Model
Dia. x Height (mm)
Capacity
3840
357 x 220
357 x 330
1
366 x 330
1
1
366 x 220
1
357 x 220
2
366 x 330
1
357 x 330
1
366 x 220
2
357 x 330
2
366 x 330
2
357 x 220
3
366 x 220
3
3850
3870
Page 87 of 88 Pages
14.
SPARE PARTS LIST
Description
15.
Cat. No.
Cap for ¼” strainer
FIL175-0027
Strainer element
FIL175-0046
Teflon gasket 4 mm
GAS082-0008
ACCESSORIES
Description
Cat. No.
Printer, PLUSII-S2B-0004
THE002-0052
High
BSK387-0001
Low
BSK387-0002
Stainless steel container High
for waste products, with
Low
vents holes
BSK387-0005
Stainless steel wire
basket
BSK387-0003
Page 88 of 88 Pages
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