Operation Maintenance Manual
Operation Maintenance Manual
Operation Maintenance Manual
&
MAINTENANCE
MANUAL
Laboratory Vertical Steam Sterilizers
Including Fast Cooling System
models 3840, 3850, 3870
ELV/WR/C/PV/BH/F-D
Page 1 of 88 Pages
6.6 History........................................................................................................52
6.7 Maintenance .............................................................................................. 54
6.8 Advanced Options ...................................................................................... 58
6.9 Version information...................................................................................60
7. 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
8. PRINTER............................................................................................................65
8.1 Printer Output............................................................................................ 65
8.2 Printer Handling........................................................................................ 67
9. PREPARATION BEFORE STERILIZATION ..................................................70
9.1 Instruments ................................................................................................ 70
9.2 Liquids .......................................................................................................71
9.3 Loading ......................................................................................................71
10. 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
11. DOOR SAFETY SYSTEM..................................................................................78
11.1 Electric door locking system ......................................................................78
11.2 Pressure switch .......................................................................................... 78
12. SERVICE AND MAINTENANCE .....................................................................79
12.1 Preventive Maintenance ............................................................................79
12.2 Checking the Safety Valve .........................................................................80
12.3 Draining the Reservoir ..............................................................................81
13. TROUBLESHOOTING ...................................................................................... 83
14. SPARE PARTS LIST.......................................................................................... 88
15. ACCESSORIES ..................................................................................................88
Page 2 of 88 Pages
TABLE OF CONTENT (Cont.)
Page 3 of 88 Pages
1. GENERAL
1.1 Introduction
Page 4 of 88 Pages
Available optional configurations
PV
Special feature of ELVCPV-D models is the vacuum pump that enables
air removal prior to sterilization and during the drying stage.
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).
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.
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. Never start using a new autoclave before the safety, licensing and
authorization department has approved it for use.
2. 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.
3. 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.
4. 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 20C below boiling temperature for sealed bottles at the end of the
cycle.
5. 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.
6. 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.
7. On closing the autoclave's door, make sure it is properly locked before
activating.
8. Before withdrawing baskets, wear heat resistant gloves.
9. 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. Open the door slowly to allow steam to escape and wait 5 minutes
before you remove the load. When sterilizing liquids, wait 10 minutes.
11. Once a month, ensure that the safety valves are functioning, and once
annually a certified tester must conduct pressure chamber safety tests.
12. Once annually, or more frequently, effective tests must be performed,
i.e., calibration and validation.
13. Examine the condition of assemblies on a regular basis. Make sure
there are no leaks, breaks, blockages, whistles or strange noises.
14. It is required to conduct maintenance operations as instructed.
15. Immediately notify the person in charge of any deviation or risk for the
proper function of the device.
16. 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).
17. 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
3.6 Specifications
MODEL
PROPERTIES
3840 3850 3870
Chamber diameter 380 (15) 380 (15) 380 (15)
400 480 680
Chamber depth
(15.8) (18.9) (26.8)
52 liters. 65 liters. 85 liters.
Effective Chamber volume (11 US (17 US (22 US
gal.) gal.) gal.)
847 847 996
Height
(33.3) (33.3) (39.2)
727 727 727
Overall dimensions Width
(28.6) (28.6) (28.6)
500 500 500
Length
(19.7) (19.7) (19.7)
Maximum Width 782 (30.8) 782 (30.8) 812 (32.0)
dimensions 1336 1336 1486
(door open) Length
(52.6) (52.6) (58.5)
28 litres
Max. water
(7.4 US
Mineral-free water volume
gal.)
reservoir
Min. water
volume
Page 11 of 88 Pages
83 kg 85 kg 100 kg
Net weight (kg)
(183 lbs) (187 lbs) (220 lbs)
0.56 m3 0.56 m3 0.56 m3
Shipping volume
(17.98 ft3) (17.98 ft3) (17.98 ft3)
99 kg (218 101 kg 116 kg
Shipping weight
lbs) (222 lbs) (255 lbs)
Max. Allowable Working pressure
2.8 bar (40 psi)
(MAWP)
3.7 Construction
3.8 Utilities
3.8.1 Electrical utility
Recommended
Power Switch box
Circuit Breaker
208-220V (3 Ph + Earthing) No 20A
380-400V(3 Ph + Neutral +
No 16A
Earthing)
230V 1ph yes 32A
Frequency 50/60Hz
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
All water connections to autoclave must be performed through
"BACK FLOW PREVENTION SYSTEM" only, as per IEC
61770.
On-Off
Page 13 of 88 Pages
FRONT VIEW (STANDARD CONFIGURATION)
5 6 7 8 9 10
11
4
12
13
2
14
1 15
No. Description
1 Front leg
2 Rear leg
3 Left service door
4 Left service door grip
5 Left service door lock
6 Door cover
7 Pressure gauge
8 Display
9 Keyboard
10 Printer cover
11 Paper slot and paper cutter
12 USB socket
13 RJ45 connector
14 Main switch
15 Printer
Page 14 of 88 Pages
FRONT VIEW (WR CONFIGURATION)
5 6 7 8 9 10
11
4
12
13
2
14
1 15
No. Description
1 Front leg (with brakes)
2 Rear leg
3 Front service door
4 Right service door grip
5 Right service door lock
6 Door cover
7 Pressure gauge
8 Display
9 Paper slot and paper cutter
10 Printer cover
11 Keyboard
12 USB socket
13 RJ45 connector
14 Printer
15 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
10
3
11
2
12
13
1
No. Description
1 Drain outlet
2 Mineral free water inlet
3 Compressed air inlet
4 Cavitation port
5 Power supply electrical cord
6 Cut-off
7 Fan grill
8 Safety Valve
9 Circuit breaker
10 Ground connector
11 City (tap) water inlet for cooling coil
12 Air pressure gauge
13 Air pressure regulator
Page 17 of 88 Pages
REAR VIEW (WR CONFIGURATION)
4 5 6 7 8
10
11
3
12
2
13
1
No. Description
1 Rear wheel
2 Water reservoir drain
3 Water reservoir overflow
4 Power supply electrical cord
5 Cut-off
6 Fan grill
7 Safety valve
8 Circuit breaker
9 Left service door lock
10 Back service door handle
11 Water reservoir door handle
12 Left service door handle
13 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 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.
3.10.2 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.
3.10.3 Sterilization
The sterilization temperature is factory set at 134C (273F)
for instruments and at 121C (250F) 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.
3.10.4 Cooling (Optional)
The ELVC autoclaves are designed to operate two liquid
cooling cycles, as follows:
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.
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
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 manufacturers
guarantee.
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.
Page 24 of 88 Pages
4. CONTROL PANEL
CONTROL PANEL DRAWING
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
Program description:
Program icon and name
Sterilization temperature
Sterilization time
Chamber temperature No. 1
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 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.
4.2 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 /
Message / Symbol
Symbol Required Action
Description
Name
This symbol is displayed
Close the door.
when the door is open.
This symbol is displayed
when there is water in Repeat the cycle
chamber.
This message is displayed
Door is open
when the door is opened: In Close the door to perform a
(during stand
standby - if START/STOP new cycle.
by)
is preset.
This message is displayed Press START/STOP in
Cycle Ended when the cycle ended order to perform a new
successfully. cycle.
This message is displayed Press START/STOP in
Test Ended
when the test ended. order to perform a new test
Enter the Admin menu as
This symbol is displayed
described in this manual to
when Cycle by Clock
change the time or to
mode is performed.
cancel this option.
This message is displayed
Enter the Admin menu as
if the user presses
Cycle by described in this manual to
START/STOP key while
clock change the time or to
the "cycle by clock" mode
cancel this option.
is active.
This message id displayed
Atmospheric in order to set the Open the door for 5
pressure not atmosphere pressure by minutes in order to set the
set opening the door for 5 Atmospheric pressure.
minutes.
Critical
settings have
been updated, If a change of the
Restart the autoclave in
Please restart autoclave setting was
order for changes to be
machine in made, a restart operation is
updated.
order for required.
changes to be
updated
This message is displayed
Perform a new cycle to
if the electrode in the
drain the chamber.
chamber senses water.
Page 29 of 88 Pages
5. STERILIZATION PROGRAMS
The autoclave offers ten sterilization programs as follows:
1
2 Plastic 121C 15
3 Liquid A 121C 15
Liquid B -- Waste
6 121C 30
Cooling
2
10 Bio Hazard 134 30
Page 30 of 88 Pages
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:
Page 31 of 88 Pages
5.1 Program 1: Glass
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
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
Page 34 of 88 Pages
5.4 Program 4: Liquid B Waste
Page 35 of 88 Pages
5.5 Program 5: Liquid A Cooling
Page 36 of 88 Pages
5.6 Program 6: Liquid B Waste Cooling
Page 37 of 88 Pages
5.7 Program 7: Vacuum Test (PV model only)
Page 38 of 88 Pages
5.8 Program 8: Bio Hazard Liquid Cooling
(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. 85C),
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
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
(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
DIRECTORY SUBDIRECTORY
Cycle Parameters applicable
only for Custom 1 and Custom 2 See sec. 6.4 Cycle Parameters (Custom 1)
programs
Print Rate All
System Parameters Print Rate Sterilization
Screen Saver
View old cycle history
History
Export history to USB
Set date and time
Export gain offset to USB
Maintenance
Printer test
Print all gain and offset
Start cycle by clock
Advanced options
Export all settings to USB device
View current version information
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
Pulse A Count Define the number of pulses in the first pulses group 3 # 0-10 1
Define the additional time that the vacuum pump will continue
Pulse A Stay
to operate or slow/top exhaust valve will remain open after 10 Second 1-100 1
Time
reaching the preset pressure in the first pulses group
Pulse A Low Define the minimum vacuum/pressure level in the first pulses
130.0 kPa 5-200 1
Pressure group
Pulse A High Define the maximum vacuum/pressure level in the first pulses
180.0 kPa 5-200 1
Pressure group
Pulses B Count Define the number of pulses in the second pulses group 0 # 0-10 1
Define the additional time that the vacuum pump will continue
Pulse B Stay
to operate or slow/top exhaust valve will remain open after 2 Second 1-100 1
Time
reaching the preset pressure in the second pulses group
Pulse B Low Define the minimum vacuum/pressure level in the second pulses
160.0 kPa 5-200 1
Pressure group
Pulse B High Define the maximum vacuum/pressure level in the second pulses
180.0 kPa 5-200 1
Pressure group
Sterilization
Define the sterilization temperature 134.0 C/F 80-137 0.5
Temperature
Sterilization
Define the sterilization time 4.0 Minute 0-9999 0.5
Time
Defines whether to perform the cooling stage or not. There are 4
Cool Mode options: 0 = no cooling. 1 = forced cooling. 2 = N.A for this 0 # 0-3 1
model. 3 = N.A for this model.
Cool End
Define the temperature at the end of the cooling stage 80.0 C/F 30-120 1
Temperature
Cool Exhaust
Defines exhaust rate at the end of cooling stage 5.0 kPa/sec 1-100 1
Rate
This parameter enables to choose between FAST EXHAUST=1
exhaust Mode 1 # 1-2 1
to SLOW EXHAUST=2
Defines the time that the heaters operate during the first drying
Dry heat On 1 4 Second 0-120 1
period
Defines the time that the heaters do not operate during the first
Dry Heat Off 1 12 Second 0-120 1
drying period
If steam is produced by heating water in the chamber, it is
possible to define two heating periods during the drying stage.
Dry First Stage
This parameter defines the first heating period. The second 5 Minute 0-120 1
Time
heating period will begin at the end of the first heating period
and will last until the end of the drying stage.
Defines the time that the heaters operate during the second
Dry heat On 2 2 Second 0-120 1
drying period
Defines the time that the heaters do not operate during the
Dry Heat Off 2 20 Second 0-120 1
second drying period
End Define the temperature at the end of the cycle , the cycle will not
120 C/F 30-120 1
Temperature end before reaching the preset temperature
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
2 Minute 1-60 1
Gap Cycles parameter is defined
Defines the printing rate during the cycle except sterilization
Print Rate All 3 Minute 1-30 1
stage
Print Rate
Defines the printing rate during the sterilization stage 1 Minute 1-30 1
Sterilization
Defines the interval from the last use of the Keypad until
Screen Saver 90 Minute 0-600 1
activating the screen saver
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.
Page 44 of 88 Pages
7. To browse through the directories, use the UP or DOWN keys.
8. When the required directory is blinking, press the START/STOP
key. The required screen will be displayed.
9. 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.
Subdirectory Property
Pulse A Count
Pulse A Stay Time
Pulse A Low Pressure
Pulse A High Pressure
Create Pulse
Pulse B Count
Pulse B Stay Time
Pulse B Low Pressure
Pulse B High Pressure
Heat Sterilization Temperature
Sterilization Temperature
Sterilization
Sterilization Time
Cool mode
Cooling Cool End Temperature
Cool Exhaust Rate
Exhaust Exhaust Mode
Dry Heat On 1
Dry Heat Off 1
Dry Dry first stage time
Dry Heat On 2
Dry Heat Off 2
End Temperature
End Multiple Cycles
Multiple Cycles Gap
Page 45 of 88 Pages
6.4.1 Create Pulse
6.4.1.1 Pulse A Count
Page 46 of 88 Pages
6.4.2 Heat
6.4.2.1 Sterilization Temperature
6.4.3 Sterilization
6.4.3.1 Sterilization Temperature
See 6.4.2.1 Sterilization Temperature
Page 47 of 88 Pages
6.4.4 Cooling
6.4.4.1 Cool Mode
6.4.5 Exhaust
6.4.5.1 Exhaust Mode
Page 48 of 88 Pages
6.4.6 Dry
6.4.6.1 Dry Heat On 1
6.4.7 End
6.4.7.1 End Temperature
Page 50 of 88 Pages
1. To increase or decrease the digits, press the UP or
DOWN keys.
2. After changing the value move the cursor to Set by
pressing the START/STOP key.
3. When Set is blinking, press the UP or DOWN keys in
order to confirm changes and return to the previous
screen.
4. 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.
6.6 History
Page 53 of 88 Pages
7. Remove the USB device from the USB Socket
8. In order to exit this screen and return to HISTORY
OPTIONS screen press START/STOP key.
9. 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.
6.7 Maintenance
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:
Page 55 of 88 Pages
5. Remove the USB device from the USB Socket
6. In order to exit this screen and return to
MAINTENANCE directory press START/STOP key.
Page 56 of 88 Pages
In order to exit this screen and return to MAINTENANCE
directory press START/STOP key.
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
Page 57 of 88 Pages
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 Advanced Options
Page 58 of 88 Pages
Enabling the START CYCLE BY CLOCK
1. To increase or decrease the time 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 move the cursor to Enabled
4. Confirm the START CYCLE BY CLOCK by
pressing UP or DOWN keys.
5. Move the cursor by pressing START/STOP key to
Exit and press UP or DOWN keys to return to
ADVANCED OPTIONS screen.
Page 59 of 88 Pages
6.8.2 Export all settings to USB device
Page 61 of 88 Pages
Automatic builder Changed (updated) automatically
after each source code
compilation
DLL size Dynamic-Link Library size
Page 62 of 88 Pages
7. SCREENS
7. Cycle Ended
Page 63 of 88 Pages
7.3 Screens following a fail cycle:
In this case, the display becomes yellow, a warning sign and the reason
of failure will be displayed.
Reason of failure
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.
Page 65 of 88 Pages
PRINTER OUTPUT DESCRIPTION
Operator: ____________ To be filled in manually by operator
Time: 12:14:47 Time sterilization cycle ended
Cycle Ended
00:24:43 101.3 099.7 Cycle finished time
E 00:23:43 107.0 107.4 The time, temperature and pressure during exhaust
E 00:22:08 134.5 311.9 The time, temperature and pressure during exhaust
CLK 2: 12:12:10:00
CLK 1: 12:12:10:00
S 00:22:07 134.5 311.6 The time, temperature and pressure during sterilization
S 00:22:06 134.5 311.6 The time, temperature and pressure during sterilization
S 00:21:06 134.6 311.0 The time, temperature and pressure during sterilization
S 00:20:06 134.5 310.1 The time, temperature and pressure during sterilization
S 00:19:06 134.8 311.1 The time, temperature and pressure during sterilization
S 00:18:06 134.5 315.8 The time, temperature and pressure during sterilization
CLK 2: 12:08:08:00
CLK 1: 12:08:08:00
H 00:18:04 134.4 315.1 The time, temperature and pressure during heating
H 00:16:35 128.9 268.4 The time, temperature and pressure during heating
H 00:13:35 116.3 180.9 The time, temperature and pressure during heating
A 00:11:04 107.0 120.9 The time, temperature and pressure during Air removal
A 00:10:22 115.1 180.4 The time, temperature and pressure during Air removal
A 00:10:00 113.7 170.5 The time, temperature and pressure during Air removal
A 00:07:00 098.7 101.5 The time, temperature and pressure during Air removal
A 00:06:45 097.6 101.4 The time, temperature and pressure during Air removal
A 00:03:45 080.2 099.4 The time, temperature and pressure during Air removal
A 00:00:45 053.7 099.4 The time, temperature and pressure during Air removal
A 00:00:04 046.5 100.0 The time, temperature and pressure during Air removal
TIME C kPa
Ster Time: 4.0min Sterilization time for selected program
Ster Temp: 134.0C Sterilization temperature in chamber for selected program
Cycle: Unwrapped instru Cycle name
Cycle Num: 000001 Cycle number
Software version A.B.CC.DD = 7.0.00.00
A: Door Type: Single motor = 7
Version: 7.0.00.00 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: 3870ELVC Model name
Ser. Num: 000000000001 Model Serial number
Time: 11:50:05 Time sterilization cycle started
Date: 9/FEB/2010 Date sterilization cycle started
-----------------------
Time: 08:51:39 Time of turning on
Date: 9/FEB/2010 Date of turning on
POWER ON The device is turned on
Time: 00:00:00 Time of turning off
Date: 9/FEB/2010 Date of turning off
POWER OFF The device is turned off
Legend
A Air removal stage (Steam flash) E Exhaust stage
H Heating stage
S Sterilization stage CLK 1 Real Time Clock
C Cooling stage (for ELVC only) CLK 2 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).
Fig. 2
Fig. 3
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.
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.
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 manufacturers
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.
9.1 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 baskets top. These baskets are intended for waste cycles, to
avoid clogging of the vessels drainage pipe by overflowing
liquids.
Page 71 of 88 Pages
10. OPERATION
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
Page 72 of 88 Pages
10.3 Opening the door
In order to open the door, follow the next steps:
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:
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:
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.
Warning
The load has not completed a sterilization cycle, therefore it is not
sterile. Handle it as contaminated load.
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!
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 users 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!
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.
12.1.3 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 Periodical Tests
1. Once every month activate the safety valve (see sec. 12.2).
Pressure-Regulating Nut
Rear Wall
Page 80 of 88 Pages
12.2.2 ASME-approved type safety valve
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.
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 / Failure Description Corrective Action
Problem
1 The main switch is in OFF 1 Turn the main switch to
position. 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.
Page 83 of 88 Pages
Message /
Symbol / Failure Description Corrective Action
Problem
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 (134C = 304 Perform a new cycle.
kPa, 121C = 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 (134C = 304 kPa, 121C = 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 / Failure Description Corrective Action
Problem
This message is displayed if the
Time Error Call the technician.
real time clock is faulty.
Door is open Close the door to perform a
This message is displayed when the
(During the new cycle.
door is open: During the cycle.
cycle)
Wait until "cycle failed
This message is displayed after the canceled by user" or "cycle
Canceled By
START/STOP key is pressed and end canceled by user" is
User
cycle aborted. displayed.
Perform a new cycle.
Cycle Failed
This message and symbol are
displayed if an error occurs before Perform a new cycle.
sterilization cycle is completed.
This message is displayed at the Wait until the autoclave
end of the cycle If the autoclave reaches the atmospheric
Air Error
does not reach the atmospheric pressure and perform a new
pressure after 10 minutes. cycle.
Compressed This message is displayed in case
Check and fix the
air supply of a compressed air supply
compressed air supply.
error malfunction.
Periodical
check time
The periodical maintenance time
exceeded - Call for service.
has passed.
Please call
for service
"Supplied
Mineral free water reservoir Fill the mineral free water
Distilled
empty" reservoir.
Water Error".
Cycle counter Number of cycles, since last
exceeded - periodical maintenance, exceeded
Call for service.
Please call for the preset number as defined by
service "cycle counter" parameter.
This message is displayed if power Turn on the autoclave and
down has occurred during the wait until the autoclave is
Power Down cycle. (this message will print out ready (reaches the safe
in the printer after the autoclave condition) and perform a
will turn on). new cycle.
Supply
distilled This message is displayed in case
Check and fix the mineral
water error of a mineral free water supply
free water supply
(digitat input malfunction.
option)
Supply water This message is displayed in case
Check and fix the city (tap)
error (digitat of a city (tap) water supply
water supply.
input option) malfunction.
Compressed
This message is displayed in case
air supply
of a compressed air supply Check and fix the air supply.
error (digitat
malfunction.
input option)
This message is displayed if the 1. check and fix the mineral
No Water
electrode in the chamber did not free water supply.
Page 85 of 88 Pages
Message /
Symbol / Failure Description Corrective Action
Problem
sense water within the preset time. 2.check and clean the water
inlet filter.
3. Clean the water level
electrode.
This message is displayed when any
Analog Input Temperature sensor or Pressure
Call for service.
Error sensor is disconnected or out of
range.
This message is displayed if the
Chamber
temperature in the chamber is too
temperature Call for service.
high or too low from the normal
not in range
range.
Chamber This message is displayed if the
pressure not in pressure in the chamber is too high or Call for service.
range too low from the normal 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
Page 87 of 88 Pages
14. SPARE PARTS LIST
15. ACCESSORIES
Page 88 of 88 Pages