&
Shredder (ISS)
OPERATION MANUAL
Page 0 of 84
TABLE OF CONTENTS
PARAGRAPH
1.
General
PAGE NO.
. 4
1.1
Incoming Inspection
1.2
Warranty
..
.. . ..
General Information . ..
2.1
Introduction
2.2
B i o - H a z ar d S t er i l iz e r an d Shredder- explanation
. .. ... 8
.. ... .. ....
Operating Conditions
. . 9
2.
2.3
2.4
2.5
Required Utilities . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... ..
... .. ... .. .
Environment Emission Information
. . .
2.6
2.7
Symbol Description
2.8
Specifications
2.9
9
10
.. . .
10
11
11
Construction
11
2.10
Water quality
........... . .
12
2.11
14
2.12
14
................ ....
15
Cycles Descriptions
3.1
3.2
...................................................... .
16
Waste Sterilization
. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. 16
... .. ... .
Dynamic Test .............. ................ ............. ............ 17
3.3
Washing c y cle . .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. 17
... .. .... .
GUI (Graphic User Interface) description . ... 18
4.1
Foreword
4.2
GUI overview
. ................
18
4.3
18
4.4
Main Screen
. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... ..
... .. .... ..
On Process Screen
. . ......................
4.5
24
4.6
System Setup
4.7
System messages
4.
.....
Page 1 of 84
18
23
25
45
PARAGRAPH
5.
PAGE NO.
5.2
Loading
5.3
5.4
Unloading
6.
...................................... .
.
53
53
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.. ...
55
. .. ... .. ... .. .... .. ... .. ... .. .... .. .
57
Installation Instructions
6.1
Mounting
6.2
Piping
6.3
Drain Connections
6.4
Power Connection
6.5
Protective Earthing
.................................................. .
57
58
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. .. .
58
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... ..
60
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60
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... .
61
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. ..
61
6.6
7.
8.
.................................................... .
Maintenance Instructions
............................................... .
8.1
8.2
8.3
8.4
Troubleshooting
9.
Valves Numbering
10.
Appendixes
62
64
66
. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... ..
...
69
........................................................ .
74
..
75
............................................................................. .
77
Drawings:
Electrical drawings
. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ..
..
78
. .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ... .. .... .. ... .. ..
..
83
EC Declaration of Conformity
FIGURES:
PAGE NO.
19
20
21
22
23
25
26
27
28
29
30
31
32
33
34
35
36
38
39
40
41
43
44
53
56
56
56
58
Fig. 29- Recommendation for Room space for the ISS installation (top view)
59
61
63
1. General
The device should be used as de scribed in this manual
only.
The following are the Instruction before operating the device:
1.1
Incoming Inspection
Immediately upon
material and contents for shipment damage (such as: scratched panel
surfaces, broken knobs, etc). Report any such insta nce to yo ur dealer or
point of purchase.
All Celitron Medical Technologies Kft. prod ucts are tested and inspected
prior to shipment.
1.2
Warranty
Celitron Me dical Technologies Kft. warrants that the equipment has been
carefully te sted and inspected and has left the fact ory in prop er working
conditions, free of visible defects. Celitr on Medica l Technolo gies Kft.
warrants th e equipment to be
free
from
defects
in ma terial and
Note :
In case you meet some difficult ies and yo u do no t find the solution in
the manual:
Contact ou r represen tative.
Inform him with mode l and se rial number of the device
Describe the difficulty.
For ISS built with a printe r: send a copy of the last printout.
Reparation
company.
is
accepted
after
ge tting
authorization
from
the
the
machin e
which
cannot
be
handled
by
2. General Information
2.1
Introduction
Blood
partials
parts
and
and
blood
of organ s
has
Sterilizer in
accordance with
equipment
EN285,
continuously operated,
ordinary
without applied parts and without signal input-output parts. The device i s
not intended for use in the presence of flammable mixtures.
made of stainless
steel.
is
equipped with one door, provided with an automatic lock ing mechanism,
activated by compressed air, preventing the openin g of the door by a
safety lock.
The ISS's op erating cy cles are us er-speci fied. Only on e general program is
available: Sterilization and
The control
system
microcomputer
operation.
of
the
device
technology,
is based
ensuring
on
highly
state
reliable
unit ensures
of
the
and
art
safe
a fully automatic
operation through the entire cy cle; he nce after setting the pre-selected
data and st arting the operation, no further intervention is necessa ry.
The selected program, the main phases of the cycle and the status of the
machine are contr olled and displayed on digital readouts. For pr ocess
documentation, the important information concerning operatio n can be
printed in hard copy (optional).
For optimal contr ol accuracy of the sterilization param eters, the system is
equipped with temperature sensors PT100 and two pressure
transducers
sens or for
chamber
printout).
A temperatur e sens or for the Filt er's te mperature (contr ol and
printout).
A temperatur e sensor for the Drain box's temperatur e (control and
monitoring).
A pressure transducer for chamber pr essure (control and printou t).
A pressure
transducer
fo r ge nerator pressure
(control
of
the
following
the
be
maintained by
instructions
gi ven
the
technician
documentation
(inclu ding
technician manual)
an d
2.2
The ISS processes Regulated Medical Waste into ordinary Municipal Solid
Waste. This means that the resultant steril e output can be safely disposed
as regular waste.
The violent action of the shredding blades allows st eam to penetrate the
waste more efficiently and eliminates the possibility of cold spots.
The resultan t waste is unrecognizable and reduced by 5080%.
Post processing, the tr eated waste is suitab le for regular
disposal.
A short explanation of the process (see piping diagram at annex 1): afte r
loading the chamber, the door automatically closes and
the chamber
from the
as an integral
part of the
and
the sealing area. The motor is of 5.5kW and is sufficient to rota te the shaft
with an RPM of 300- 1400 for v a rious operations. The blades are mounted
on the shaft and are designed in a way that it shreds waste such as
paper, small textile, plastic and glass. The blade is made of h igh carbon
steel with hardened cutting edges.
2.3
Operating Conditions
See
meters (ambient
2.4
Required Utilities
2.5
sound
for
2.10),
and
found
to
be
in
compliance
with
the
requirements.
Note:
The nois e level of the machine has been meas ured and found in
compliance
However,
the
noise
level
also
to
the
operators,
after
level
installation,
it
is
regulati ons. In case the noise appear s too high, use protective
measurements such as ear covers.
2.6
The installa tion and the service of the device sh ould consider
precautions regarding EMC according to the information
special
accompanying
as
replacement
parts
may
result
in increased
2.7
Symbol Description
This sign indicates the need of caution. Read accurately
all the notes beside this sign.
2.8
Specifications
MOD E L
ISS AC -5 50
ISS AC -575
500
600
500
800
110
160
Weight (Kg)
500
600
130x20 0x1 9 4 cm
Chamber Door
1 A ut omat i c Doo r
121 C - 140 C
Steam Source
Saturated St eam
Steam Pr essure
2.5 - 3.5 BA R
Test Pr essure
5.0 B A R
5.0 - 7.0 B A R
Water Source
Pressure
Power So urce
3-Ph.4 0 0 V, 50 /6 0 Hz
16Kw
2.9
25Kw
Construction
The main parts of the device are made of materials as indicated below:
Chamber is built of stainless steel AISI 316L thickness 4mm.
Door is made of stainless steel AISI 304.
2.10
Water Quality
The Mineral- free wate r supplied to the steam generator should have the
physical characteristics and maximum acceptable level of co ntaminants
indicated in the table below:
Maximum values of contaminants in Feed water and Condensate
in accordance wi th Standard EN 285
Contaminant
Feed water
Condensate
Evaporation residue
10 mg /l
1 mg/l
0.1 mg / kg
Iron
0.2 mg/l
0.1 mg / kg
Cadmium
0.005 mg/l
0.005 mg/kg
Lead
0.05 mg/l
0.05 mg / kg
0.1 mg/l
0.1 mg / kg
Chloride (Cl)
2 mg/l
0.1 mg / kg
Phosphate(P 2 O 5 )
0.5 mg/l
0.1 mg / kg
5 ms /cm
3 ms /cm
pH value
5 to 7
5 to 7
Hardness
0.02 mmol/l
0.02 mmol/l
Appearance
colorless clean
without
sediment
colorless clean
without
sediment
2.10.1
si s
R e v e rs e Os m o
A Reverse Osmosis system is highly reco mmended for use to im prove the
quality of the water used to ge nerate steam into the device's chamber.
The use of mineral-free water will contribute to better
performance and
2.10.2
Water
Cooling
for
th e
cleaning
System
and
th e
Drain
The feed water supp lied to the liquid ring ejector must meet the followin g
requirements:
Hardness:
The use of
forbidden!
soft
water
is
stri ctly
Note:
The use of heavy scaled water for th e cleaning and cooling, can cause
blocking of the valves/pipes and pu t the elements out of operation.
This invalidates the guaran tee for the device.
2.11
60204-1:2006+ A1:2009
Safety
of
machinery-
Electrical
Electromagnetic
compatibility
(EMC)- Generi c
Electromagnetic
compatibility
(EMC)- Generi c
Quality standards
The compa ny's quality managemen t system meets the following quality
standards:
2.12
be in the
range should
be of 700 1060
hPa
diapason.
Equipment may be moved only with empty Water Reservoirs.
The device shall be transporte d packed in wooden boxes,
wooden
pallets.
The
boxes'
dimensions
are
upon
approximately
2.13
Safety Devices
Approved ThermostatsThese safety components interrupt the heating element in case of the
temperature
above
150C
f o r chamber
and
170C
f o r steam
generator. In order to precede the work, the user needs to push the
reset button.
PressostatThis safety component interrupts the he ating elem ent in the steam
generator in case of the pressure above 3.3 BAR.
Certified Safety ValvesThis safety
component
releases
the
pressures
above
2.76
Door
Motor
rollers-
Safe ty
Sw
Frequency
Cont
BAR
3. Cycles Descriptions
The device offers 1 sterilization cycle, 1 test cycle and 1 cleaning cycle.
3.1
W aste Sterilization
Sterilization temperature: 138C (273F), 0C +3C, (0F +5.4F)
Sterilization time: 10 minutes.
Dry Time: 5 minutes.
Vacuum pulses: 1.
Average cycle time: 25 minutes.
Cycle Sequence
L o a d i n g : waste is loaded into the chamber. The door closes and the
chamber rotates to the process position (fully vertical).
Sh re ddi n g : The shredder starts working with the start of the cycle in different
speeds, as required. The shredder continues working in high speed for 2
minutes. After this time elapses, the shredder stops working.
St e r i li z a t i o n s t age :
remove the air from the chamber. He a t ing Stage : Steam is introduced into
the chamber until the
pressure are
controlled at
and
the
sterilization level for the sterilization time. The Bio Filter valve
30 seconds closed
is achieved in the
chamber by
controlling the Compressed air to chamber and the top Exhaust valves via
the bio-hazard filter, until the end of the cycle.
Unloadin g : the chamber rotates to the unloading position and the waste is
evacuated to the bin.
Note: it is important to implement the following test (Dynamic test)
at least once every working week, to detect leaks which may cause
infection to the operator and the environment!
3.2
Dynamic test
The purpose of this test is to detect leakages under pressure.
Operations Sequence
Water and steam are introduced into the EMPTY chamber at 138C
for a preset pressure (2.4 bar), for 5 min.
The shredder is operated to create a vortex.
During periodic Maintenance, or if a leak has been detected during
this test, a technician may use leak detection foam to detect the
source of leakages during this test.
3.3
Cleaning cycle
Operations Sequence
Water and steam are introduced into the EMPTY chamber for 5 min;
steam is introduced to the filter to clean any remaining residues.
The system holds a temperature
Foreword
4.2
GUI Overview
as temperature,
textual messages, icons etc. A Screen also contains required keys. Based on
the system process, the screens will be changed. In this case the GUI will
display required information and will allow required input from the user.
4.3
Main Screens
The Main screens enable basic User-Machine interaction. The main screens
display the data when the device is on standby mode and displays different
data when the system performs sterilization process. 3 types of main screens
are available:
4.3.1 Stand-by Screen
This screen is automatically displayed after the system is started. This screen
is used to display useful information when the system is on Stand-by: Ready
status of the machine, Errors, Failures and other messages are displayed.
parameter setup and many other operations that will be described later in
this paragraph.
Chamber
Pressure
Chamber
Temperature
Clock
Load
Number
Message
Selected
Cycle
4.3.1.1
4.3.1.2
Ready Stat us
If the machine is not ready to perform a sterilization process, the reason will
be
displayed
on
Stand-by
the
START
key
is
4.3.1.3
Error/Failure
4.3.1.4
Door Operation
DOOR screen:
b. Touch the required field in order to rotate the chamber to the correct
position.
LOAD- will open the door while the chamber is in Load position.
UNOAD- will rotate the chamber to Unloading position.
CLOSE- will rotate the chamber to Working position and close the door in
order to start a cycle.
STOP- will stop the process.
4.4
On-Process Screen
Process
Status
Chamber
Temperature
Chamber
Pressure
Process
Graph
Selected
Cycle
4.5
Select Cycle
Pressing this key will display Select Cycle screen, which enables changing
current cycle. This key is enabled only when the device is on standby.
Open Door
This key is available on standby, when inside
conditions
(pressure and
temperature) are not dangerous. Pressing this key will open the chamber
door.
Reset Error
This key is displayed when the device is on standby and an Error/Failure
occurs. Pressing this key will reset the error and will return the device to
normal mode. (In some cases, pressing this button will display ENTER CODE
screen, if the error reset is allowed to authorized people only).
Menu Key
Pressing this key will show the MENU screen. It enables setup of the system.
4.6
System Setup
Pressing the
Select the required setup action by pressing the icons shown on the screen.
Pressing the EXIT key will go back to the main screen.
MENU screen.
to submit.
screen.
screen will be displayed. After typing the code and submitting, the system
will display the OPTIONS screen:
the
PARAMETERS'
screen.
Only
submitted
by
user-level,
to select
to submit.
4.6.7 C a li b r ati on of a n al og i n pu ts
MENU screen.
and
will display
d. Browse the analog inputs list using the UP and DOWN keys
to submit.
Change Gain & Offset Direct typing of Gain and Offset values.
Calculate Gain & Offset Calculating Gain and Offset by two points.
Restore Values Restore Gain and Offset values with factory defaults.
4.6.7.2
a. To change the Gain and the Offset, use 'UP' and 'DOWN' keys
next/previous field.
to submit.
to cancel.
saves
new values
to the
systems RAM, meaning that if power off happens at this time, new values
will be
reset
to previous.
The system
saves
Gain and
Offset values
Calculating
Gain
and
Offset
by
two
to
to cancel.
saves
new values
to the
systems RAM, meaning that if power off happens at this time, new values
will be
reset
to previous.
The system
saves
Gain and
Offset values
The Calculation of the calibration values for the analog inputs (temperature,
pressure) is performed in a digital way and not by adjustment of trimmer
pots.
The temperature
and
pressure
measuring
circuits
are
designed
with
pressure range 0 to 400 kPa. The measuring at the A/D is void for values
higher than 2400mV or lower than 100mV.
It is clear that even though the precision of the components of the circuit is
1%, the accumulated error can reach 5%, therefore the calibration is
necessary. The system is provided with non-erasable memory in which the
offset and gain data of the sensors are stored. This data may be fed to the
system through programming or through the machine.
The calibration method enables to introduce these data into the system in
order to perform the automatic correction of the OFFSET and GAIN.
It is recommended to find the two points, which have to be fed to the
system, before performing the calibration.
1. Browse the calibration list using the UP and DOWN keys and select the
required:
a. Read.H: - Read high value of the analog input.
b. Act. H: - Actual high value of the analog input.
c. Read.L: - Read low value of the analog input.
d. Act. L: - Actual low value of the analog input.
Analog Inputs
MENU screen.
and
will display
4.6.8.2
Digital Inputs/Outputs
and
MENU screen.
and
will display
Proces s History
The system saves last cycles printouts and enables printing of the saved
cycles (optional- for device with a printer).
In order to print a cycle from the history:
MENU screen.
and
will display
and
4.6.11
n
Ex ternal ke y o p erat io
cycle.
Red Button: Stops any movement of the chamber and door.
When the
sterilizer is in a sterilization cycle, pressing the red button will abort the cycle
and "Manual Stop" indication will be displayed.
Up Button: Pressing this button while the device is not during a sterilization
process will bring the chamber to a LOADING position.
Down button: Pressing this button while the device is not during a sterilization
process will bring the chamber to an UNLOADING position. While the
chamber is in UNLOADING position, pressing the DOWN button will operate
the shredder's motor for 4 seconds and will open the Clean filter valve for 2
seconds. This action is performed in order to help waste to fall out to the bin.
4.6.12
Fig. 23-
System messages
4.6.13
Error Messages
System errors are disp layed in RED color on the main screen. When the
device is on process, the error will fai l t h e steriliza t i o n cycl e
. The RED
light in the towe r lamp will be On. Reset error operation is required in order
to bring the sy stem to the normal mode.
will be
vacuum
15-Low Heat
This message is displayed if the system can't
conditions in the chamber after 20 minutes during the Pre heating and
Heating stages.
16-Press1 Cut
This message is displayed when the Chamber Pressure sensor fails.
17-Chamb Move Err
This message is displayed if the chamber's position is incorrect.
18-Doors Sw Err
This message is displayed when the door switches are in an abnormal
position.
19-Ring Open Err
This message is displayed if the Door's Ring Unlock process fails.
20-Err Water Pump
This message is displayed when the Water Pump which supplies water to
steam generator fails.
21-Test Fail
This message is displayed when the Dynamic Test cycle fails.
22-No I2C Com.
This message is displayed when the communication between the main
electrical board and I/O board fails.
24-Chamb Angle Err
This message is displayed if the chamber's position is incorrect.
25-No Gen.Source
This message is displayed if there is no mineral free water in the reservoir.
4.6.14
on standby. If one
No Gen Water
This message is displa yed if there is no water in the
generator.
Door Open
The message is displa yed when the Door is no t
closed.
No Steam
This message is displayed if the generator pressure is too low. The message
disappears when the pressure is above required pressure.
No Compressed ai r
This message is displayed if compressed air supply has been interrupted.
No Seal Press
This message is displayed if pressure in the sealing is too low.
4.6.14.1 The following messages are displayed in YELLOW when the
chamber is in moving process:
6-OperPos D.Open
The machine is waiting for the door to reach its safety position before
chamber movement.
7-OperPos Go Back
The chamber
back
is
moving
8-L o ad DoorClosed
The machine is wait ing for the door to be completely open when in lo
ad position.
9-Load DoorMiddle
The machine is wait ing for the door to be completely open when in lo
ad position.
10-Load Go Back
The chamber is moving back to Load position.
11-Load Go Forward
The chamber is moving forwar d to Load po sition.
12-Serv.DoorOpen
The machine is waiting for the door to reach its safety position before the
chamber is moving to service position.
13-Serv.Go Back
The chamber is moving back to service po sition.
14-Serv.Go Forward
The chamber is moving forwar d to service position.
15-Unload D.Close
The machine is waiting for the door to reach its safety position before the
chamber is moving to unload position.
16-Unload D.Open
The machine is waiting for the door to reach its safety position before the
chamber is moving to unload position.
17-Unload Go Back
The chamber is moving back to unload po sition.
18-Unload GoFrwrd
The chamber is moving forwar d to service position.
19-Limit AT M.Prs
The machine is waiting for the pressure in the chamber to reac h its safety
value before the cham ber is moving.
Safety Sw Off
Main door is open.
Check Safety Sw
Safety Switch is faulty.
Basket miss ing
The trash ba sket (bin) is missing.
4.6.14.2 Exhaust stage messages ( White color):
Exh Water Cooling
Cooling of the chamber through the water sprinkler.
Exh Pres surizing
Pressurizing the cham ber with compr esse d air befo re water removal.
Exh Water Remove
Removing water from the chamber.
Exh Finalizing
The machine is waiting for the safety pressure and temperatur e in the
chamber.
FAIL
This message is displayed on standby stage when sterilization cycle fails.
Door Open
This message is displayed on standby stage when the door is open.
Opening Door
This message is displayed on standby stage when the door is on unlocking
process.
Water Inlet
This message is displayed on process when the water inlets to the chamber
the chamber.
Steam O n
This message is displayed on Heating stage when the system creates
pressure by steam in the chamber.
Heating to Ster.
This message is displayed on Heating stage when the system creates
sterilization conditions.
Sterilizin g
This message is displayed on Sterilization stage.
Exhaust
This message is displayed on Exhaust stage.
Dry
This message is displayed on Dry stage.
CYCLE END
This message is displayed on standby stage when the sterilization cycle
successfully ends.
TEST ENDE D
The message is displa yed when the Dynamic Test is finished.
The treatm ent in the ISS requires that different kinds of waste shall be
worked up on
separately.
of
all involve d
below
recommendations
for
waste
Note:
Any
segregation
method
to
be
implemente d
shall
be
in
can
be
supplied
upon
S=sharps;
I=isolation
waste;
L=lab
is the
wastes
allowed
excludi n g
amounts
of
blood
and
b o dy fluids; A=animal
waste;
Place an empty bag into the Waste Bin before starting the cycle. At
the end of the cycle, close th e bag and dispose it a designated
waste
collection
area .
(Note
th at
the
waste
is
considered
to make
sure sterilization is
5.2
Loading
When loading the waste to be steriliz ed into the chamber, observe the
rules de scribed in this chapter.
Before each cycl e, verify that the door gasket and the surface that
the gasket is pr essed on are clean an d intact.
Do not overload the chamber as th is can have adverse effects on
the results of the sterilization an d drying programs !
CAUTION- during loading
wet floor!
Maxi mu m Load :
~25kg o r 1 25 li te
r
5.3
5.4
Unloading
On completio n of the cycle, the load shall be imme diately removed from
the devie and a visual inspection shall be made to assure that the load is
dry, or that sterilizing indicators have made the required color change.
wet floor!
6. Installation Instructions
Only qualified
and
to install,
Comp. Air
Inlet
n Outlet
Drai
Electricity
connection
Mineral
Free
Water
connecti
on
Water Inlet
Extern
al
Stea
m
Connectio
n
Fig. 28- Utilities Connection on the rear side of the ISS (illustration)
6.1
Mounting
After unpacking the device, ch eck that the Serial Number (S/N) on its
nameplate corresponds wi th the package number.
Place the device on a level surface, leaving ade quate space of
minimum 4m x 3m, height 2.4m around it for operat ion and service
requirements. (Also see fig. 29 below).
The ambient temperature around the device must not exceed
40C and 80% humi d ity.
Do not use the device in presence of dangerous gases and vapors.
The floor in the
device area
must
be
Waterproof
and
non
The floor construction should contain drain hole in the lowest place
of floor. All device ar ea floor co nstruction have to provide incline
toward the drain ho le, in orde r that the rest of the water will be
able to flow out through the drain without obstacles.
The ceiling
above the
device should
be Waterproof
and
non
and
top
level of the
device is designated to
to
and
pe rs onnel,
shou ld be
having
only for
prop er
Fig. 29- Recommendation for Room space for the ISS installation (top view)
in
6.2
Piping
Connect th e feed wa ter inlet to the wate r reservoir, using a 1/2
pipe, 3-4 atmospheric bars, with a carbon-active filter.
Connect th e air connector from the device to the building's air
source
using
atmospheric bars.
10/8
mm
If there
plastic
pneumatic
is no external
tube,
6-8
6.3
Drain connections
Connect dr ain outlet box to the drain 2"-4"
Note:
The drain
Usage of an air filter (At the air chimney of the drain box).
rules and
apply
the
6.4
Power connection
The device
must
be connect ed to
the Power
with a safety
and
n a tional
6.5
Protective Earthing
The Wall fuse box for the device's power supply (400V/50Hz, 32A or
40A) should be equipped wi th a match in g earthing clamp (o r
Earthing screw) at least 8AWG (10mm 2 ).
Avoid direct contact with live parts or areas th at ar e marked with a
"High voltage" sign!
Prel im in a ry ch eck
-up
After installation and
prior to putting
the
present in the
Code->
Change
Parameters
EXTERNAL DIMENSIONS
7. Operating Instructions
Open the feed water manual valve.
Set the incoming compressed air pressure to 8 bar, and set the
regulator's pressure in the machine to 6 bar.
Turn on the main power switch, to power the electric system of the
machine.
Wait until the tower la mp is green and no t flashing, which indicates
the machine is ready, and the display has a "Ready" message.
Watch the pressure parameter on the screen, indicating the rising of
steam
pressure.
When
the
pressure
reaches
bars
the
the
sterilizer, keeping
in
mind
the
recommendations
Close the door, the word OK appears in the first row, indicating that
the device is ready to start operation.
Press the START key to operate the cycle. The enti re ster iliz ation
process au tomaticall y proceeds. The 'START' icon on the co
ntrol panel is light.
Wait until the chamber reaches its position and the waste is being
evacuated to the bin. (If necessary, press the "Down" butt on to
rotate the blades). Remove the bag filled with waste.
Warning!
Loading
or unloadi ng of material
from the
chamber can be
cycle will stop the machine . In case, fo r any reas on, a pers on is
stuck in the loading area while the door is closed, an Emerge ncy
button is mounted in side the machine, behind the display and
the contro l buttons. In case a cycl e fails, th ere is a risk of
contaminant an d biohazard. In this case opening the door is not
allowed.
8. Maintenance Instructions
Warning!
Maintenance
tasks
are
to
be
performed
only
providing
the
8.1
B e fo r e ea
ch cycle
pr es se d o n ar e c l ean a n d i n ta ct .
Use a soft b r ush to cle a n if ne cessary.
Caution! D o not u s e st eel woo l o r steel b r ush as this ca n damag
e the chamber!
1. Cl ean the g ask et wi th a so ft cl oth.
da ily
month l y
3 m o nth s
A f ter 50 0 cy cl
es or 6 m o nth s
6 m o nth s
1. Repl ac e T a p wa te r fil t e r .
2. Repl ac e RO syste m me mbrane an d fil t er.
3. Put a fe w drops of lub r i can t on th e doo rs' h i ng es.
Cl ean wate r stra ine r s on stea m and fe ed wa te r i n le t pipe s whil e t
he de vice do e s no t op era t e (idl e).
1. Ch eck
an d tig h ten
c o nne c t ion
ec tri cal
an d i n st rum e n t at i o n w h er e n e c e s s a r y
val v es
box ,
mo tors,
.
2. Ch eck
Mai n
ye a r l y
Te mpera t u r e
and
P r e s sure
2 ye ars
5 ye ars
ce wo rn pa r t s.
A fter 10 00
wo rk ing hours
A fter 15 00
wo rk ing hours
A f ter 30 00
Repl ac e Bearings
wo rk ing hours
A fter 40 00
wo rk ing hours
( t oge t he r with
the
seals,
the
bea ring
oil,
Note:
Keeping the inside of the chamber clean will lengthen its life
and its pr op er operation.
Periodical Tests
Check all safety devices from time to time and re-regulate if necessary.
Once a year, calibrate and validate the device. Periodical safety tests
derived from
local
rules,
regulations
or
law
shall
be
applied
in
8.2
operating manual .
Test the condition of the supply lines of the device at regular
intervals for crac ks or possible mechanical damage. After the end
of a sterilization cycle, close all the valves and taps of the supply
cables, such as those for cooling water and compressed air .
The Sterilizer is equipped with two safety valves, located at the
chamber and
the
regularly inspected
least
once a
year)
as
the
device is
by
an
authorized
customer se rvice agent, the prev entive relieving of the valves is not
necessar y. To chec k the operation of the safety valves, turn the
pressure relief nut counter cloc kwise for 2 seconds. Verify steam
escapes from the valve. Atte ntio n: Use protective gloves in order
not to burn your hands with the hot steam. Press the STOP key to
interrupt the oper ation, and exha ust steam from the chamber.
8.3
8.4
Troubleshooting
Sym p t o
ms
1. Con t rol u nit is no t en ergi zed .
No displ ays a n d ligh t s o n the fro
nt
2pane
. Lo wl . pr ess u re or n o st eam
t h e co nt ro l p o i nt .
re red u ce r.
calib ra ti on.
3.2 Lea kag e throug h the stea m to coi l val v e .
m pre s sure.
4 . 2 L o w pr es s u r e at t h e st e a m su pp l y li n e .
5 . T e mp er at ur e r i s e s ab ov e t h e
5 . 3 C o n t ro l s y stem pr ob l e m .
Page 69 of 84
Sym p t o
ms
6. Fast or sl ow exh a ust pha s es
do n o t fu n c t i on ; ch amb e r p r e
o r da mag ed.
ss u r e
6 . 3 C o n t ro l s y stem pr ob l e m .
tooDlong.
7.
r yi ng stage doe s n ot work.
7 . 2 C o n t ro l s y stem pr ob l e m .
9.1 Se t th e te m p . and ti me co r re c t
of s t e r il i z at io n p r oc es s
t e mp er at ure or pr es su re to o l o w , st er . t i me
t o o sho r t.
ty of material.
1 0 . 1 S et or f i x t h e pr es su r e sw it c h.
e re mains w e t.
8. Th e a ir in let do es no t wo rk .
the cond en s a t e.
10.3 In co rrec t lo adi ng of the cha m be r.
Page 70 of 84
Sym p t o
ms
11. P r o ble ms rela ted to the con trol
sys t e m .
an d keyboa rd a r e we ll pl ug ged i n.
of ord er.
is unsu itabl e.
P r es s i n g one k e y give s t h e ef fe ct
of pre ssi ng a diffe r en t ke y. Cycle do
es no t s t a r t wh en p r e ssi ng th e
ST A RT
1 1 . 7 Tem per at ur e s en s o r is d i sc o nn e ct
key.
Prin ter do es no t wo rk or pri n
ting is
ed.
W h i l e s w itch i n g t h e dev i c e
on ,
mage d.
Page 71 of 84
Sym p t o
ms
1 2 . C ham be r d o es not rotate t o
12.2 D r i v e malfu nc t io n
he cha m be r ( s ee p ara. 5. 2)
14.3 Mo to r malfu n c t io n
14.4 Con t ro l syste m fa il ure
15. T h e l oa d is moi s t a t th e e n
d of steri liza t i on cycl e
16. Do or do es n o t cl ose
1 6 . 1 C le a n t he do or and t h e f l an ge
1 6 . 2 V e r i fy th at t h e c h amb e r i s n o t
overl oad ed or tha t th ere is no obj e
ct bloc king th e do or an d/ or th e
flan g e.
Page 72 of 84
Sym p t o
ms
1 7 . Leakage from t h e ma c h i n e
In c a se of de tec t i o n of a leakag e o n
ly op en
the f l o o r or s u rr oun d in g ar ea , i m me
di at el y:
E v acua te all p e rsonnel a n d sea l the
room,
con t act a t echni ci an t o pr ovi d e i n stru cti
o n s a n d co ntact a third pa rty to hand le
the
haz a r d ous su bstances removal.
Page 73 of 84
9. Valves Numbering
The valves in the draw ing and this manual are numbe red according to it s
function.
1.
Separator Valve
Water to Separator
2.
Water Chamb.
Water to Chamber
3a.
Steam Chamb.
Steam to Chamber
3b.
Steam
4.
Clean Filter
5.
6.
7.
Fast Exhaus t
8.
Cooling Drain
Cooling to Drain
9.
Vac. Valve
10.
11.
12.
Page 74 of 84
Part
41100033
41100034
41100035
41100046
41100047
41100048
41100049
41200001
41300001
Valve 1/2 GC 2W
41300003
41300004
41300005
41400001
41400002
41400003
41400004
41400005
41400006
41400007
41400009
41400010
41400011
41400012
41400013
41400016
41700001
41700004
41900001
43200001
43300001
43300004
45000001
45000002
45200025
45200028
45200029
46100001
Page 75 of 84
Catalogue No.
49000060
Part
Double acting piston without damping & magnetic
piston D=20mm,L=70mm,ISS
Gasket seal for ISS
49000062
49000063
49000069
49000072
49000073
49000085
49000090
49000091
49000095
49000096
49000058
Page 76 of 84
Appendixes:
Page 77 of 84
Page 78 of 84
Page 79 of 84
Page 80 of 84
Page 81 of 84
Page 82 of 84
Page 83 of 84
Page 84 of 84