3.2 The Piping System ------------------------------------------------------------------------------ 22
Piping System Drawing ------------------------------------------------------------------------ 24
MAN205-0195042EN Rev. A Aug. 2011
i
Page 4
Table of Contents (Cont.)
3.3 The Pneumatic Control System ------------------------------------------------------------- 25
Pneumatic Control System Drawing ------------------------------------------------------- 26
Upon receipt, the autoclave should be unpacked and inspected for mechanical damage.
Observe packing method and retain packing material until the unit has been inspected.
Mechanical inspection involves checking for signs of physical damage such as:
scratched panel surfaces, broken knobs, etc.
If damage is apparent, file a claim with the carrier. The manufacturer is responsible for
products supplied Ex Factory. These 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.
WARRANTY
We certify that this device 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 the Preventive and Periodical
Maintenance paragraph.
Our obligation is limited to replacing the device or parts, after our examination, if within
one year after the date of shipment if they prove to be defective. This warranty does not
apply to any device that has been subjected to misuse, neglect, accident or improper
installation or application, nor shall it extend to products, which 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!
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.
Stipulate the model and serial number and describe the difficulty as clearly as possible
so that we may be able to identify the problem and hence provide a prompt solution.
For technical information or service please contact:
PARAMEDICOS de EL SALVADOR
Prolongacion Calle Arce,
Edificio # 3020,
Entre 57 Y 59,
Av. Norte.
San Salvador,
EL SALVADOR.
The autoclave has unique characteristics. Please read and understand the operation
instructions provided by the manufacturer before the first operation of the autoclave. The
following issues may require clarification: The operation of the autoclave; the door safety
mechanism; the door closing mechanism; the dangers involved in circumventing safety
means; and finally, the selection of an appropriate sterilization program.
Make sure that you know the placement of the main power switch, the position of the
water cut-off valve, where the steam and compressed air disconnection valves are
located.
Autoclave maintenance is crucial for the correct and efficient function of the device.
The daily B&D test and the weekly spore test are part of the preventive maintenance
plan, along with the annual validation of the sterilization processes that ensures
appropriate temperature dispersion within the chamber.
Warning!
Never use the autoclave for the sterilization of corrosive products and chemicals ,
such as: Acids, bases and phenols, volatile compounds or solutions such
ethanol, methanol or chloroform nor radioactive substances.
Safety Operation Instructions
1. NEVER start a new autoclave or a new steam generator, before the safety,
licensing, and authorization department has not 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;
preservation from corrosion; and finally, what is permitted and what is
prohibited for sterilization and choosing a sterilization program.
4. If there is a steam generator – drain it daily.
5. If there is an air compressor – drain it daily.
6. Before use, check inside the autoclave chamber to ensure that no items have
been left from a previous cycle.
7. Before loading the autoclave, clean the strainer on the chamber floor.
8. Load trays in such a way as to allow steam to move freely among all items.
9. Liquids may be sterilized only with the ―liquids‖ program. 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.
10. 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.
MAN205-0195042EN Rev. A Aug. 2011
Page 2 of 137 pages
Page 9
11. Individual glass bottles may be placed within an appropriate container that will
be placed on a tray. Never place glass bottles on the floor of the autoclave.
Never fill more than 2/3 of the bottle volume.
12. On closing the autoclave door, make sure that it is properly locked before
activating.
13. Verify once again that you have chosen the appropriate sterilization program.
14. Before withdrawing trays, wear heat resistant gloves.
15. Before opening the door, verify that there is no pressure in the chamber
(chamber pressure gauge is located on the autoclave's front panel).
16. Open the door slowly to allow steam to escape and wait 5 minutes before you
remove the load. When sterilizing liquids, wait 10 minutes.
17. Once a month, ensure that the safety valves are operating; and once a year,
that a certified inspector performs a chamber pressure safety test.
18. Once annually, or more frequently, effective tests must be performed, i.e.,
calibration and validation.
19. Check the condition of assemblies on a regular basis. Make sure there are no
leaks, breaks, blockages, whistles or strange noises.
20. Perform maintenance operations as instructed.
21. Notify the person in charge immediately of any deviation or risk of proper
function of the device.
22. It is strictly forbidden for any person to enter the autoclave‘s chamber. If, for
any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system with the key
and take the key with him.
Instructions for Contaminated Waste
1. Verify that the contaminated waste at the sterilization station is packed in the
correct bags/containers.
2. Verify that there are no leaks and that the package is correctly marked.
3. Large containers with a narrow spout may ―behave‖ like a sealed bottle.
4. It is preferable to sterilize solutions in small containers rather than in
differently-sized containers or in large containers.
5. It is recommended not to stand in front of the door when it opens, because
steam may be discharged when the door is opened.
6. It is recommended to support sterilization bags at the bottom – especially
when they are hot.
Attention:
IF THE UNIT IS USED IN MANNER NOT SPECIFIED BY THE MANUFACTURER,
THE PROTECTION PROVIDED BY THE EQUIPMENT MAY BE IMPAIRED.
KEEP THE DOOR CLOSED DURING THE DAY OR SHIFT. WHEN THE AUTOCLAVE
IS NOT OPERATING, AT NIGHT OR ON THE WEEKEND, LEAVE THE DOOR OPEN.
MAN205-0195042EN Rev. A Aug. 2011
Page 3 of 137 pages
Page 10
1. GENERAL INFORMATION
1.1 Introduction
This autoclave is designed to cover a large field of applications for hospitals and medical
centers as well as pharmaceutical and biotechnological industries.
The autoclave operates with saturated steam as the sterilizing agent, and has a
temperature range of up to 137C (279ºF) and pressure up to 2.3 bar (34 psi).
The autoclave is equipped with a 36 kW built-in steam generator. This steam generator
acts as a standby if building steam is not available for the sterilization process.
The autoclave is built to receive two steam supply sources, namely from the building, or
from an internal built in steam generator. There is a selector switch on the Front Panel to
choose the source. Before selecting the external generator, check the generator is
connected to the electrical supply and working properly.
The autoclave is equipped with two vertical sliding doors. Each door is operated by two
hydro-pneumatic cylinders mounted laterally on both sides of the door. Each cylinder
contains an integrated and separated oil system. The operation of the cylinders is
performed by air pressure and the oil system acts as a speed control system. An
adjustable restrictor controls the flow of oil from one side to the other side on each
cylinder, controlling the speed movement of the door. (For servicing of the unit see the
SERVICING INSTRUCTIONS chapter.)
The autoclave is mounted through a recessed wall. The two doors are located in two
separate rooms.
The front door, on the side of the master control panel is in the preparation area, from
where the autoclave is operated and serves for loading the material into the sterilization
chamber. This area is known as the "dirty side." The rear door is located on the "clean
side" and serves for unloading the sterilized material from the autoclave. This side of
autoclave is equipped with secondary control panel (slave).
The sealing of the chamber is achieved through a heat resistant silicone gasket, located
in a groove around the door opening of the autoclave. The gasket is pressed against the
door by steam pressure introduced into the groove behind the gasket.
The interlocking system of the door is based on the following opening conditions:
A door cannot be opened while the autoclave is in operation.
A door cannot be opened if the chamber is under pressure.
A door cannot be opened if there is liquid in the chamber.
Both doors cannot be opened at the same time. Opening of one door
automatically locks the other.
MAN205-0195042EN Rev. A Aug. 2011
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Page 11
After opening the door on the dirty side, even after closing it and it being
locked and sealed, the door on the clean side can be opened only after
performing a complete sterilization cycle.
If cycle failed, the front door only can be opened.
After test cycle, the front door only can be opened.
A door cannot be opened at the end of the cycle if the chamber temperature is
higher than the preset final temperature.
The electronic circuitry and software programming of the programmable control system
are designed to operate 10 sterilization programs. Three programs are intended for unwrapped instruments, four for wrapped instruments and packs, three for slow exhaust
pressure cycles. In addition, there are two test programs: Bowie & Dick Test and the
Leakage Test.
The control system of the sterilizer is based on microcomputer technology, ensuring a
highly reliable and safe operation. The computerized control unit ensures a fully
automatic operation through the entire cycle; hence, after setting the pre-selected
parameters and starting the operation, no further operator intervention is necessary.
The autoclave has an automatic shutdown system. If no buttons or switches are
operated for four hours, it will go into SLEEP MODE and a LED lights up (blinking every
second), indicating that the system is in the SLEEP MODE.
The selected program, the main phases of the cycle and the status of the machine are
controlled and displayed on digital readouts. For process documentation, the important
information concerning operation is printed.
The system is equipped with two temperature sensors,four pressure transducers, five
pressure gauges, and safety devices having the following functions:
The temperature sensors:
1. In the drain – (control)
2. In the condensate line(double) – (control, monitoring, and printout)
The pressure transducers measure:
1. Chamber pressure – (control, display, and printout)
2. Jacket pressure – (control and monitoring)
3. Door 1 gasket pressure – (control and monitoring)
4. Door 2 gasket pressure – (control and monitoring)
MAN205-0195042EN Rev. A Aug. 2011
Page 5 of 137 pages
Page 12
Front Panel
Service Area
1. Chamber pressure
2. Jacket pressure
3. Door 1 gasket pressure
4. Door 2 gasket pressure
5. Steam generator pressure
The pressure gauges:
The safety devices:
1. RT112 pressure switch – (prevents the opening of the door if there is
pressure in the chamber)
2. Two ALCO pressure switches – (prevents the operating of the door if
there is no vacuum in the door gasket)
3. RANCO over pressure switch – (control the over pressure of the steam
generator)
4. SMS VM830 end switch – (prevents the pressurizing of the chamber
and the door gasket if the door is not closed)
5. Two Safety Bars – (prevent the door from trapping any object while
closing)
6. A GICAR controller connected to a water level electrode in the chamber
prevents opening of the door if there is liquid in the chamber.
The keyboards located on both the front and rear panels enables the operator to select a
sterilization program, start/stop a cycle, and close or open a door.
A programming mode, which can be accessed by a code from the front panel only,
enables the technician to set up the system, set and change a number of additional
parameters and operational modes and performing a calibration.
Optionally, a personal computer can be connected to the control system, through the
interface board RS232, which can be operated up to 8 meters away from the autoclave.
The PC, operating under WINDOWS displays the status, data and processing in real
time in graphic and digital form at the same time recording and logging the data. For a
distance more than 8 meters, a RS485 interface and a modem are required.
The communication PC-control unit enables the complete control of the autoclave
through the PC, including program selection, starting and stopping a cycle, setting of
parameters, and the real time clock (date and time of the day).
The autoclave is equipped with ―Emergency Stop‖ push-buttons and key locks, mounted
on both the front and rear panel. This feature is designed to prevent human hazards,
accidents or equipment breakdown in compliance with the European standards EN-285
requirements.
MAN205-0195042EN Rev. A Aug. 2011
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Page 13
Warning!
Do not operate the autoclave in the presence of dangerous gases and vapors.
It is strictly forbidden to enter the autoclave chamber!
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and
unauthorized use.
When emergency switch is activated, the key must be used to allow the switch to return
to the operating position.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
MAN205-0195042EN Rev. A Aug. 2011
Page 7 of 137 pages
Page 14
Legend:
1. Pressure Gauges
2. Emergency STOP Switch
3. Operation Panel
4. Printer
5. Operating Switch
6. Steam Selector Switch
7. Chamber
8. Service Access Panel
7
5
2 3 1
4
6
8
1.2 Front Panel
MAN205-0195042EN Rev. A Aug. 2011
Page 8 of 137 pages
Page 15
Product data
Model 6671130 2VEP
Chamber capacity
610 l
Chamber dimensions
W
660 mm 26"
H
710 mm 28"
D
1300 mm 51"
External dimensions
W
1040 mm 41"
H
2020 mm 80"
L
1720 mm 68"
Degree of protection
IPX 4
Utilities
Tap Water supply
Maximum hardness value 0.7-2.0 mmol/l
Recommended temperature 15°C (60°F)
1. Connection: ½" thread
2. Pressure: 2–5 bar (30–70 psi)
Steam
1. Connection: ¾" thread
2. Pressure: 3.5–4.5 bar (60–65 psi)
Distilled or Mineral free water
1. Connection: ½" thread
2. Pressure: 2–5 bar (30–70 psi)
See chapter "Water Quality"
Compressed air requirements
1. Connection: ¼" thread
2. Pressure: 6–8 bar (85–115 psi)
3. Consumption: 100 LPM
Electrical data
3 Ph, 208V/ 60Hz, 105 A
Electrical cable requirements
5X50mm2
1.3 Standards
Tuttnauer. Ltd. company meets the provisions of the Medical Device Directive
93/42EEC and PED 97/23EEC and the following standards:
ASME American Society of Mechanical Engineers
Section VIII, Division 1, for unfired pressure vessels.
AAMI/ANSI-ST8 Hospital sterilizers
EN 285 Large Sterilizers.
EN 554 Validation and routine control.
UL UL 61010-1
IEC IEC 61010-2-040 Safety
Tuttnauer. Ltd. is also approved for:
ISO 9001:2008 (Quality Systems)
ISO 13485:2003 (Quality Systems for Medical Devices)
ISO 17665-1:2006 (Validation and Routine Control)
1.4 Specifications
MAN205-0195042EN Rev. A Aug. 2011
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Page 16
Symbol
Description
Caution! Consult accompanying documents
Caution! Hot surface
Caution! Hot steam
Protective earth (Ground)
Utility
Specification
Mineral Free Water
2–5 bar (30–70 psi)
Steam
3.5–4.5 bar (60–65 psi)
Tap Water
2–5 bar (30–70 psi)
Compressed Air
6–8 bar (85–115 psi)
Electricity
3 Ph, 208V/ 60Hz, 105 A
1.5 Symbol Description
1.6 Utility Labels
MAN205-0195042EN Rev. A Aug. 2011
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Page 17
2. INSTALLATION
2.1 Environmental Conditions
Ensure all shut-off valves or switches from the building services to the autoclave, for
example compressed air, electricity, steam, water, etc. are clearly marked, and are
located in an easy to reach, unrestricted area.
Ensure all personnel working with or around the autoclave are properly trained in the
location of all the shut off valves and switches that supply services from the building to
the autoclave.
The ambient atmosphere around the autoclave must not exceed 40 ºC (104 ºF), 80%
relative humidity, and the room should be ventilated 10 air changes/hour.
Place warning signs related to the possible dangers of operating autoclaves in
prominent positions. See the Symbol Description paragraph for explanations of the
dangers.
Warning!
Do not use the autoclave in presence of dangerous gases and vapors.
2.2 Mounting
Place the autoclave on a suitable level surface, leaving adequate space around it for
operation and service requirements.
Level the autoclave before connecting the utilities.
Utilities
Connect the autoclave to the utility supplies as follows:
Air
Connect the air connection of the autoclave to the compressed air supply of the building
by means of a ¼‖ pipe at 6–8 bar (85–115 psi).
Water
The autoclave is supplied by two water systems:
1. Tap Water
Tap water for the vacuum pump and cooling the heat exchanger;
Hardness should not exceed 0.7–2 mmol/l See also chapter "Water
Quality".
Pressure should be in the range of 2–5 bar (30–70 psi)
Connection to the network by a ½‖ pipe.
2. Distilled or Mineral Free Water
Distilled or mineral free water for the steam generator.
Connect the distilled or mineral free water reservoir to a distilled or mineral
free water supply source by a ½" pipe.
Pressure should be in the range of 2–5 bar (30–70 psi)
See also the Water Quality paragraph!
Attention
Connection of water systems to the autoclave must be performed through "BACK
FLOW PREVENTION SYSTEM" installation as per EN 1717 regulations and local
regulations.
MAN205-0195042EN Rev. A Aug. 2011
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Page 18
Drain
Connect the following outlets directly to the drain funnel. or connect them
through a drain collector pipe of 4-6‖ that should be covered. The drain
system should be vented.
General drain outlet by a ¾" pipe.
Vacuum pump by a 1" pipe
Steam
Connect the building steam supply to the autoclave inlet by a ¾" pipe.
The steam supply pressure should be between 3.5–4.5 bar (50-65 psi).
(See also Utilities Table).
The steam trap on the building steam supply should not exceed 2 meters
from the machine.
MAN205-0195042EN Rev. A Aug. 2011
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Page 19
Electrical data
3 Ph, 208V/ 60Hz, 105 A
Electrical cable requirements
5 X 50 mm2
Electrical Power Connection
Warning!
Only a qualified electrician may perform the electrical connections!
The electrical units should not be placed near water sources.
Connect the power cord to the electric box of the autoclave
Note:
Before operating the vacuum pump, make sure that the pump shaft is free and
you can turn it with a screw driver.
Warning!
It is strictly forbidden to enter the autoclave chamber!
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and
unauthorized use.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
MAN205-0195042EN Rev. A Aug. 2011
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Page 20
2.3 Preliminary Check
After installation, and prior to putting the machine into operation, the following checkout
procedure is to be fulfilled:
Check the connection to local sewage. Check that the sewage pipeline is
not clogged. (Pour water for this task).
Check the connection to compressed air, pay attention to the door, set the
pressure to 6-8bar.
Check the connection to tap water. Open the water valve. Manually test the
water valves by over-riding the appropriate solenoid valve. If there are no
leaks – rotate backwards the solenoid by-pass. Leave the manual inlet taps
open.
Check the connection to mineral-free water. Open the water valve. Test
manually the water valves by over-riding the appropriate solenoid valve. If
there are no leaks, rotate backwards the solenoid by-pass. Leave the water
manual inlet taps open.
Close the building manual steam inlet valve, and turn OFF Building inlet
using the ON-OFF-ON switch on the front panel.
Open the generator electric box, switch ON the 3 Phase circuit breaker with
it‘s Trip Coil, and ensure all the other circuit breakers are ON.
Turn ON Generator steam inlet using the ON-OFF-ON switch on the front
panel.
Check that the jacket pressure gauge, reaches 2.4bar. Press the Test
button mounted on the generator electric box to de-activate the internal
steam generator.
Check connections to building steam. Open the steam valve, and turn ON
Building inlet steam and turn OFF Generator steam inlet using the ON-OFFON switch on the front panel. Manually test the steam valves by over-riding
the appropriate solenoid valve. If there are no leaks, –leave the steam inlet
tap open.
Check that the Cover for the Microbiological Filter has been removed.
Check the connection to electricity – To be performed by an authorized
electrician only!
Check the direction of the vacuum pump motor rotation.
MAN205-0195042EN Rev. A Aug. 2011
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Page 21
Performing Safety Tests
Check the tightness of all the nuts and screws.
Test the earth continuity – use a Megaohm Tester.
Check current leakage. Check Voltage and Amperage.
Adjust the legs of the transfer carriage to equal the height of loading cart to
rails in the sterilization chamber.
Turn ON the steam generator.
Check connection to steam generator. Open the steam. Manually test the
steam valves by over-riding the appropriate solenoid valve. If there are no
leaks, –leave the steam manual inlet taps open.
Run a cycle.
Call for an authorized inspector to test and approve the autoclave; generator
and, assembled system.
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Page 22
3. FUNCTIONAL DESCRIPTION
3.1 The Steam Generator
A built-in steam generator is installed to act as a standby if building steam is not
available for the sterilization process. See ―Switching to Steam Generator‖ section for
steam generator operation. The power consumption of the generator is 36 kW.
Water to the steam generator is supplied by a one-phase pump, from a water reservoir,
which is connected to a source of distilled or de-mineralized water. The electrical system
of the steam generator is located in a separate electric box.
The water level control system consists of three electrodes connected to the GICAR
2DRLHG controller, which commands the operation of the water pump and servo
solenoid valve to switch OFF the heating current in case of lack of water or low water
level.
Use only distilled or mineral-free water for the operation of the generator!
Caution!
It is strictly forbidden to use soft water; this may results in corrosion of the
generator.
Warning!
Only a qualified electrician may perform the electrical connections!
The electrical units should not be placed near water sources.
When servicing the generator, disconnect the all electrical power supplies to the
unit. This is done by switching OFF the main power supply switch, or by unplugging the electrical power main supply cords.
It is important to achieve an electrical good grounding connection to the sheet
metal enclosure of the electric box and metal parts of the generator.
The earth installation at the customer’s site must be built in compliance with the
laws and regulations in force, and should meet international electrical safety
standards, and be certified by competent authorities.
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Page 23
DescriptionDateRev.NoECO
400mm
R/L1S/L2T/L3
PowerHeatersWater
Fault
Fault Light
On Generator
electric box
Circuit Breaker
(OFF)
Trip Coil
3.1.1 Electrical Safety System
There is an electrical safety system to protect the heating elements if a fault condition is
detected by any one of the safety devices, namely:
Water level too low
Pressure too high
Temperature too high, (if applicable)
The fault light on the generator box will light up, and the main heater circuit breakers will
be switched OFF.
If this happens, do not try to correct the fault yourself, but call for assistance.
3.1.2 The Water Pump for the Steam Generator
The water pump supplies the distilled or mineral-free water to the steam generator.
The supply line of the pump is connected to the upper water reservoir filled with distilled
or mineral-free water and mounted on side of the autoclave.
A float valve keeps a constant level of water and prevents an overflow of water out of the
reservoir.
A lower float switch stops the operation of pump, when the water level drops below the
lower level limit.
MAN205-0195042EN Rev. A Aug. 2011
Page 17 of 137 pages
Page 24
GICAR 2DRLH
S
R
1
S
M
1
S
m
1
S
R
2
S
M
2
S
m
2
RL1
RL2
S
E
SE
L N
RL1
RL2
Water
Pump
Heater
Electrode
Low Low
Reference
Electrode
low
(heater)
Electrode
high
(water )
444546
VAC
1
23
Dimensions in mm
Front of Generator
3.1.3 GICAR Water Level Controller
The water level control system consists of three electrodes. (HIGH and LOW water
level), and a reference electrode, all connected to the GICAR 2DRLHG controller.
The long electrode which is continuously immersed in the water, acts as a reference and
is connected to ground.
The medium electrode (LOW level electrode) controls the water heaters. When it stops
sensing water, the GICAR controller stops the current to the water heaters. When it
senses water, the GICAR controller restores current to the water heaters.
The short electrode (HIGH level electrode), controls the water pump. When it senses
water, the GICAR controller stops the current to the water pump and simultanausly
closes water supply shut off valve. When it stops s ensing water, the GICAR controller
restores the current to the water pump and simultanausly opens water supply shut off
valve.
MAN205-0195042EN Rev. A Aug. 2011
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Page 25
Description:
Page:
Design:
Rev No.
Drawing:
Prepared by:
Job No.
Approved by:
Scale:
Quant./Job:
Drawing No.
Cat. No.
Q. C.
Quant./Unit:
01
ISO
A3
Preparation By:
DescriptionDateRev. No ECO
Generator electrical layout for
2 sets of heater with neutral
From:
1
4
ES1G08-0001-N
Marchel N. Changes in page 3
20/1/10
01
400 mm
200 mm
400 mm
Main Switch
42
41
40
39
38
37
36
35
46
45
44
43
TB4
1
PS
24VDC
8
NO
CR1
5
1
L1
3
L3
13
NO
5
L5
2
T2
4
T4
6
T6
14
NO
A1
A2
Heater 2
KM2
3
1
L1
3
L3
13
NO
5
L5
2
T2
4
T4
6
T6
14
NO
A1
A2
Heater 1
KM1
3
PLC
CB
L1
T1
CB3
L1
T1
CB4
44
L3
T3
L2
T2
T1
L1
CB1
3
L3
T3
L2
T2
T1
L1
CB2
3
Marchel N.
22.8.10
Yuval S.
22.8.10
See page 4
TC Test
3ph Line Feed
To Water
Pump
PE N
TB1
L2
N
PE
TB3
L1
N
PE
TB2
L2 L3
3 ph
To control panel
PLC
CB
D1
6
D2
TC2
PLC
CB
D1
6
D2
TC1
9
R/L1S/L2T/L3
PowerHeatersWater
Fault
GICAR 2DRLH
S
R
1
S
M
1
S
m
1
S
R
2
S
M
2
S
m
2
RL1
RL2
SES E
L N
RL1
RL2
10
GENERATOR ELECTRICAL LAYOUT
MAN205-0195042EN Rev. A Aug. 2011
Page 19 of 137 pages
Page 26
TC1<
T/L3
S/L2
R/L1
Heaters 1
L3
L2
L1
T3
T2
T1
Q0
L3
L2
L1
T3
T2
T1
C1
KM1
L3
L2
L1
T3
T2
T1
CB1
TB1
N
To
Control
Panel
L1
L2
L3
PE/GND
PE/GND
TB2
Description:
Design:
Rev No.
Drawing:
Prepared by:
Job No.
Approved by:
Scale:
Quant./Job:
Drawing No.
Cat. No.
Q. C.
Quant./Unit:
01
ISO
A3
Preparation By:
DescriptionDateRev. No ECO
Generator power electrical diagram for
2 sets of heaters with neutral
Page:
From:
2
4
Marchel N.
Yuval S.
See page 1
ES1G08-0001-N
Heaters 2
L3
L2
L1
T3
T2
T1
C2
KM2
L3
L2
L1
T3
T2
T1
CB2
TC2<
Legend:
1. HEATERS = 208V /6000W
2. KM1 & 2 = CONTATOR: DILM65
GENERATOR POWER ELECTRICAL DIAGRAM
MAN205-0195042EN Rev. A Aug. 2011
Page 20 of 137 pages
Page 27
Description:
Design:
Rev No.
Drawing:
Prepared by:
Job No.
Approved by:
Scale:
Quant./Job:
Drawing No.
Cat. No.
Q. C.
Quant./Unit:
01
ISO
A3
Preparation By:
DescriptionDateRev. No ECO
Generator Control Electrical Cascade Diagram
for 2 sets of heater with neutral
ES1G08-0001-N
Page:
From:
3
4
Marchel N.
Yuval S.
See page 1
Heater 2
C2
A1A2
N
R1
Water Pump
Water Lamp
CB3
4A
T
Heater 1
C1
A1A2
L
Steam
Pressure
TB1
Heaters Lamp
Power
TC1
D1
37
L
CB4
4A
T
Pressure
Cut off
33
32
NO
Level Elec. Low
RL1
Q0/L1
Fault Alarm
Q0/L2
2
TB3
TB3
PS
24VDC
LN
GICAR
2DRLH
LN
38
~ VAC
Temperature
Cut off
36
M
D2
35
34
TC Test
Trip coil 1
TC2
D1D2
Trip coil 2
24VDC
+-
Level Elec. High
RL2
Water Supply
Pressure/Float
43
Air Supply
Pressure
42
NC
R1
2
1
Water Valve
41
40
39
Water Relay
GICAR 2DRLH
S
R
1
S
M
1
S
m
1
S
R
2
S
M
2
S
m
2
RL1
RL2
S
E
S E
L N
RL1
RL2
Water
Pump
Heater
Electrode
Low Low
Reference
Electrode
low
(heater)
Electrode
high
(water )
444546
VAC
1
23
36 33 35
GENERATOR CONTROL ELECTRICAL CASCADE DIAGRAM
MAN205-0195042EN Rev. A Aug. 2011
Page 21 of 137 pages
Page 28
3.2 The Piping System
The piping system of the autoclave consists of air-operated valves, which control the
condensate and steam flow in and out of the chamber, operate the vacuum, and the air
inlet valve. The air pulses to the pneumatic valves are transmitted through solenoid pilot
valves, operated at 24VDC.
The functions of the valves are as follows:
Steam to jacket (91) – introduces steam into the jacket to accelerate the heating of the
chamber and to maintain a stable and uniform temperature in the chamber during the
sterilization and drying stages.
Steam inlet valve (93) – introduces steam from the jacket into the chamber, for heating
and maintaining the chamber temperature during the sterilization phase.
Building steam inlet valve (90) – introduces steam directly from the building source
into the system. This valve is controlled by an ON-OFF-ON switch on the front panel.
Generator steam inlet valve (92) – introduces steam from the steam generator into the
system. This valve is controlled by an ON-OFF-ON switch on the front panel.
Air inlet valve (43) – introduces filtered ambient air into the chamber at the end of the
cycle to break the vacuum and enable the opening of the door.
Fast exhaust and vacuum valve (75) – This valve performs two functions:
1) To exhaust the steam from chamber.
2) To connect the chamber to the vacuum pump to create vacuum in the
chamber in the air removal and drying stages.
In both actions, exhaust and vacuum, the flow path of the fluids is through the condenser
(heat exchanger) and the vacuum pump to drain.
Condensate valve (74)– evacuates the condensate from the chamber during heating
and sterilization phases and isolates the chamber from the drain pipe, during vacuum
generation. It operates like a slow exhaust valve at the end of slow pressure programs.
Water to vacuum pump valve (15) – is connected to the tap water reservoir and
supplies the water required by the operation of the vacuum pump.
Water to heat exchanger valve (12)– introduces tap water to the heat exchanger to
cool the fluids at the inlet of the vacuum pump.
Pressure to gasket valves (94 1-2) – control the steam pressure to the door gaskets.
When the doors are closed, steam enters through the valves into the grooves behind the
gaskets pushing them against the doors to seal the chamber.
MAN205-0195042EN Rev. A Aug. 2011
Page 22 of 137 pages
Page 29
Vacuum to gasket valves (53 1-2) – connect the gasket grooves to the vacuum pump.
When a door moves, during opening and closing, this valve is open and vacuum is
produced to draw the gasket into the groove, ensuring a smooth sliding of the door.
When the door is open, this valve is operated but vacuum is not produced.
Mineral free water inlet valve (21) – allows distilled or mineral free water from the
pump and prevents the return flow of hot water from the steam generator to the
reservoir.
Note:
The valve numbers are in accordance with the valve numbering list and piping
diagram.
MAN205-0195042EN Rev. A Aug. 2011
Page 23 of 137 pages
Page 30
PIPING SYSTEM DRAWING
MAN205-0195042EN Rev. A Aug. 2011
Page 24 of 137 pages
Page 31
3.3 The Pneumatic Control System
The pneumatic control system is built as follows (refer to drawing on the next page):
The compressed air is supply at a pressure of 6-8 bars.
Pressure regulator reduces the pressure to 6 bars.
Air is transmitted to the inlet of the pilot solenoid valve battery, which is mounted on a
manifold branch base. Through the manifold, all the solenoids are connected to the
compressed air supply.
The 24VDC solenoids are operated by controller.
When the solenoid is operated, it transfers the compressed air to activate the
appropriate air valve.
The pneumatic valves are of two types:
1. Air operating, and air closing valves.
These valves operate in pairs only (94 1 & 53 1) and (94 2 & 53 2) The piping is
arranged so that a command sent from one solenoid valve opens one valve and closes
the other in the pair. In this manner each valve in the pair of valves operates opposite
each other.
2. Air operating, and spring closing valves.
Air-activated and spring-return are fitted with two commands:
An opening command comes from a solenoid valve at a pressure of 6 bars output by the
control system, and a permanent closing by a built-in spring valve.
Solenoid-operating valves
In addition to the solenoid valves which control the air-operated valves, the pneumatic
system also has solenoid valves which have a direct action as described below:
Close door valves (39 1-2); are servo solenoid valves which transmits compressed air
to the door closing systems.
Open door valves (38 1-2); are servo solenoid valves which transmits compressed air
to the door opening systems
Pneumatic door safety devices:
1. RT112 pressure switch – (prevents the opening of the door if there is pressure
in the chamber)
2. SMS VM8 End switch– (prevents the pressurizing of the chamber and the door
gasket if the door is not closed)
3. ALCO pressure switch – (prevents the operating of the door if there is no
vacuum in the door gasket)
MAN205-0195042EN Rev. A Aug. 2011
Page 25 of 137 pages
Page 32
PNEUMATIC CONTROL SYSTEM DRAWING
MAN205-0195042EN Rev. A Aug. 2011
Page 26 of 137 pages
Page 33
ELECTRIC
CONNECTIONS
3.4 Absolute Pressure Transducers
The transducer type MT 3296 is a membrane pressure sensor and electronic measuring
circuit, with the following specifications:
The autoclave is fitted with four pressure transducers for controlling & monitoring:
1. Chamber pressure – (control, display, and printout)
2. Jacket pressure – (control and monitoring)
3. Door 1 gasket pressure – (control and monitoring)
4. Door 2 gasket pressure – (control and monitoring)
The terminals at the connector of the device are 1 (+24V) and 2 (OUT) to the controller
output.
MAN205-0195042EN Rev. A Aug. 2011
Page 27 of 137 pages
Page 34
3.5 The Vacuum Pump and the Heat Exchanger
For the generation of vacuum in the air removal and dry stages, the autoclave is
equipped with a water ring seal vacuum pump – Speck V 55, suitable for continuous
operation, and for achieving high vacuum.
The tap water necessary for the operation of the pump is supplied by the water
reservoir, connected to the tap water source.
The water level in the reservoir is maintained by a mechanical float valve.
A float switch mounted on the lower side of the reservoir prevents the pump running in
case of low water level in the reservoir.
A condenser (heat exchanger) is mounted on the vacuum pump inlet piping, to cool
down the steam exhaust from chamber before getting inside the pump, using tap water
as a cooling fluid.
Two important goals are achieved by this action:
1. It reduces the temperature of the fluids flowing through the pump;
therefore the scaling of parts is eliminated.
2. The efficiency of the vacuum pump is greatly improved through the
transformation of steam into condensate, resulting in a dramatic
increase of the vacuum generation speed.
The quality of tap water is very important for maintaining the vacuum pump and the
autoclave in good condition and prolonging the life duration of the machine. Refer to the
Water Quality paragraph.
Note:
After servicing the vacuum pump, make sure to reconnect the earth connection.
Vacuum pump Speck V 30/55
UL= connection for ventilation valve UV=connection for drainage valve
UB= connection for operation liquid Ue=drainage (screwed plug)
Note:
Before operating the vacuum pump for the first time, make sure that the pump is
free and you can turn the main axle with a screw driver without force.
Verify that the pump motor turns in the right direction.
MAN205-0195042EN Rev. A Aug. 2011
Page 28 of 137 pages
Page 35
Electrical data
3 Ph, 208V/ 60Hz, 105 A
Electrical cable requirements
5 X 50 mm2
3.6 The Electrical System
The electrical system of the autoclave comprises of the power circuits including the
commands, switching, and protective components required for the operation of the
electrical equipment of the unit.
The following parts are located in the electrical boxes, mounted on the side of the
autoclave:
Electrical control board.
Solid state relays (SSR) for the command of the water and vacuum pumps,
and heating elements.
Circuit breakers for protection of all power circuits.
Power supplies for powering of electronic circuitry and solenoid valves.
Wiring and connection elements.
Main power switch for the autoclave and switch for steam generator.
The power circuits of the steam generator are connected to the live terminals in the
electric box at a three-phase voltage:
It is important to achieve a good grounding connection to the metal-sheet enclosure of
the electric box and metal parts of the autoclave.
The earth installation at the customer‘s site must be built in compliance with the laws
and regulations in force and International IEC 61010-1 electrical safety standards and
certified by the competent authorities.
Warning!
Only authorized electricians are allowed to install or attend the electrical system!
Description of the Electrical Equipment (see Steam Generator and Electrical
Drawings)
MAN205-0195042EN Rev. A Aug. 2011
Page 29 of 137 pages
Page 36
The command circuits are energized by a power supply with two outputs, as indicated
below:
5 VDC for the digital circuits.
24 VDC for the solenoid valves.
The coils of the solenoid valves are 24V and are operated by the controller. The
solenoid valves are activated when the control voltage output is low (less than 2V) with
respect to ground. A Circuit Breaker (CB1 4A) protects all power circuits.
Electrical control for vacuum pump
1. Overload protector (PKZM 0-6.3)
2. Solid State Relay (SSR)
3. Contactor(DILM12)
4. Cat 2007 Controller
In case of an interruption on any of the phases, the overload protects the vacuum pump
from damage by disconnecting the three-phase line from the vacuum pump.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
MAN205-0195042EN Rev. A Aug. 2011
Page 30 of 137 pages
Page 37
3.7 The Control System
The Main Board
Controls and monitors the physical parameters of the process and performs the
operation sequence of the machine, according to the selected program.
The main board contains the following elements:
16 digital inputs
24 digital outputs
6 PT 100 inputs
7 inputs of 4–20mA
Voltage inputs for the electrodes for water level
2 analog outputs of 4–20mA
Serial ports
CPUs.
2 ADCs for reading temperature and pressure sensors.
Each ADC maintains at least 3 temperature sensors (PT100), and 3 pressure sensors
(4–20mA).
All connections to the main board are via rigid connectors for quick and efficient
dismantling.
Digital Inputs
The digital inputs are 0/1:
Open/close for door positions
Safety cut-off switches
Pressure cut-off switches
Switches for water level
The input voltage is 24VDC. The input is protected from high voltages by means of an
Opto-coupler.
Digital Outputs
Digital outputs are used to activate solenoid valves, relays and SSR for the pumps and
heating elements.
Each output is up to 2A, however all the outputs together will not have a capacity higher
than 110 W.
The command voltage is 24 VDC, but it can vary in the range of 10–30VDC.
MAN205-0195042EN Rev. A Aug. 2011
Page 31 of 137 pages
Page 38
Analog inputs for Reading Temperature
Temperature is measured using PT100.
The system contains 2 ADC components, each component being able to read 3 PT100
sensors. The system contains circuits with a direct connection of PT100 (3 wires) that do
not interchange on the way.
The measurement range is 25–150ºC (80–300ºF).
The resolution is 0.1ºC (0.2 ºF).
The accuracy of the temperature is + 0.5ºC (1 ºF).
Calibration of the temperature circuits requires a special engineer access code.
Analog Inputs for Control and Reading Pressure
The system contains 6 inputs for control and reading transducer pressure from
4–20mA sensors. There are at least 3 sensors on each ADC.
The chamber, the jacket, and the gasket are monitored by the pressure transducers.
Each sensor has an output of 4–20mA. The system allows the measurement range of
the sensor to be set by external software (via RS232).
Measuring chamber pressure
The display and printing scale are in kPa and psi units.
The measurement range is 0-400 kPa (30 inHg–72 psia).
The resolution measurement and display is 1kPa (0.15 psi).
The accuracy of the measurement is a maximum 1% of the range, i.e. +5 kPa (1.0 psi).
Calibration of the pressure circuit requires a special engineer access code.
Measuring jacket pressure
The measurement range is 100-400 kPa (14.5–72 psia).
The resolution measurement and display is 1 kPa (0.15 psi).
The accuracy of the measurement is a maximum 1% of the range, i.e. +4 kPa (0.5 psi).
Calibration of the pressure circuit requires a special engineer access code.
Measuring door gasket pressure
The measurement range is 0–400 kPa (31.5 inHg–72 psia).
The resolution measurement and display is ±1kPa (0.15 psi).
The accuracy of the measurement is a maximum 1% of the range, i.e. +5 kPa (1.0 psi).
Calibration of the pressure circuit requires a special engineer access code.
MAN205-0195042EN Rev. A Aug. 2011
Page 32 of 137 pages
Page 39
Measuring steam generator pressure
The measurement range is 100-600kPa (14.5–87 psi)
The resolution measurement and display is 1kPa (1 psi).
The accuracy of the measurement is a maximum 1% of the range, i.e. 5kPa (0.7 psi)
Calibration of the pressure circuit requires a special engineer access code.
3 Serial Ports
The control system contains 3 serial ports (1optional) according to the following
specifications:
2 Serial Ports for the connection of up to 2 command panels.
1 Serial Port connected to an external PC computer (RS232/485).
1 Serial Port (optional)
Serial Port RS232 is included in the system to connect to an external PC up to a
distance of 8 meters. If it becomes necessary to convert certain functions or to
reprogram or reload software of the autoclave from a distance of over 8 meters, a
modem and Serial Port RS485 is required. This enables service technicians to attend to
the unit from a remote site. ADMC software enables full control of the autoclave.
MAN205-0195042EN Rev. A Aug. 2011
Page 33 of 137 pages
Page 40
Description:
Material:
Design:
Rev No.
Drawing:
Prepared by:
Job No.
Approved by:
Scale:
Quant./Job:
Drawing No.
Cat. No.
Q. C.
Quant./Unit:
Marchel Nir
12-7-09
02
Marchel Nir
12-7-09
Safety Interlocks schem
ES1C01-0010
To Eliwell
Electrode high
(water )
Sm
L N
SM R
1 2
GICAR DRLH
GICAR
Uri H.
12-7-09
Safety Interlock 2 (SI 2)
+24V
From GICAR
FromEliwell
+24V
10111276123
Power
Supply
Eliwell
Pt100
Sensor
IC912
Out
ISO
A3
Preparation By:
DescriptionDateRev. No ECO
To RT112
1212
Power
Supply
Marchel N.
Change contacts to Eliwell from NC to NO
9/9/2009
01
01
01
RL
PLC
Marchel N.
Add Eliwell contacts
19/10/2010
02
02
Fromoutput-13toRelay
SAFETY INTERLOCK DEVICES
MAN205-0195042EN Rev. A Aug. 2011
Page 34 of 137 pages
Page 41
TUTTNAUER
ISO
A4
Description:
Design:
REV. No.
Drawing:
Job No.
Scale:
Drawing No.
Quant./Unit:Quant./Job:
Approved by:
Cat. No.
Q. C.
00
Drawing for horizontal autoclave with two sliding doors
The ON/ST.BY key is located on the top right side of the panel. Press this
key to light up the operation panel. When there are 2 panels, both light up
even though only one was operated.
3 Command Keys
F1- 3: Functions 1- 3
F1 F2 F3
These keys are found under the display. The function to be performed is displayed
above each key.
10 Digit keys
These keys are used for 2 purposes:
Under normal working conditions the program option is used. Press on the number key.
For example, no. 3 selects program 3.
Under the display mode, the keys are used as number keys to enter a code or a
number.
UP/DN Keys
Under normal working conditions, they are used to browse through the
different cycles.
Under set-up mode they change numeric value or move the display to the
next screen.
MAN205-0195042EN Rev. A Aug. 2011
Page 38 of 137 pages
Page 45
START Key
When the autoclave is in the Ready position, pressing START activates
the cycle.
STOP Key
This key is active while the autoclave is in operation. Pressing STOP at
any stage of the cycle stops the operation.
Canceling the FAIL message
At the end of an aborted process the FAIL light is turned ON and an error message is
displayed on the screen indicating the cause of the failure.
Press the STOP key to cancel the displayed message and switch off the FAIL light.
RUN/FAIL LEDs
The operation panel contains 2 small LEDs which are located on the
top left corner. The RUN LED (green) lights when the autoclave is in
process. When the system has been turned OFF by the ST.BY key,
the RUN LED will flash for 1/2 a second for every 2 seconds indicating that the system is
still ON. The FAIL LED (red) lights when there is a problem with the system.
MAN205-0195042EN Rev. A Aug. 2011
Page 39 of 137 pages
Page 46
First Row
4.1.2 Display
Note:
Temperature and pressure measuring units differ according to the country of
operation. Temperature and pressure are displayed in both ºC or ºF and kPa or
psi, respectively.
The CAT2007 display consists of 4 alphanumeric rows with 20 characters in each row
(see Figure below)
First Row
First 3 characters define the Cycle no. (ranges from 1–12)
8 characters define the cycle name.
The 5 final characters at the right end of the row are allocated for displaying the status of
the autoclave or the stage of the cycle in operation.
1. ST. BY - indicates that the autoclave is in the waiting stage.
2. READY - indicates that the machine is ready for operation.
3. END - indicates that the process has ended correctly.
4. FAIL - indicates that the program has ended due to failure.
The 12 cycles, names of programs and relevant temperatures are listed below:
Second Row:
This row displays the temperature in the chamber, pressure in the chamber, and jacket
pressure.
Third Row:
This row is used to display messages to the operator such as DOOR1 OPEN.
Fourth Row:
On the bottom row, the names of the commanding keys appear. Under the display there
are three keys without symbols or names. These keys receive their commands by the
name that appears above them in the 4th row of the display. During a cycle, the fourth
row is used to display the timers, such as STE Time 02:25, or during pre-vacuum, to
display the stage of the pulse, such as puls1 – pump to 21K.
MAN205-0195042EN Rev. A Aug. 2011
Page 41 of 137 pages
Page 48
03 - Manual Stop
This message is displayed and the FAIL indicator lights up
after the STOP key is pressed for more than 1 second during
the cycle (excluding the drying stage).
100 - Man. Stop
This message is displayed and the FAIL indicator lights up
after the STOP key is pressed for longer than one second in
the drying stage.
05 - Door Unlock
This message is displayed if either of the following occurs:
The START button is pressed and the door is not closed or
if during a cycle or the pressure drops in the gasket.
06 - Temp. Error
If the temperature sensor is disconnected for any reason
during the heating stage, temperature is either higher than
140ºC (284ºF) or lower than 5ºC (41ºF).
07 - Low Heat
This message is displayed and sterilization does not start if
the autoclave has not reached sterilization temperature after
heating for the maximum time as defined in the HEAT T.O.
parameter.
08 - Low Temp.
This message is displayed, fail indicator lights up and cycle is
aborted, if the temperature drops for more than 5 secs. below
the required sterilization temperature.
09 - High Temp.
This message is displayed, fail indicator lights up and
program is aborted: If the temperature rises by 3ºC (5ºF)
above the required sterilization temperature during the
sterilization cycle.
10 - Low Pres.
This message is displayed, fail indicator lights up and the
program is aborted if the pressure drops for more than 5 sec.
below the pressure correlated to the required sterilization
pressure.
11- High Pres.
This message is displayed, fail indicator lights up and the
program is aborted, if pressure rises above the pressure
correlated to the sterilization temperature by 3ºC (5ºF) for
more than 5 sec.
12 - Low Vacuum
This message is displayed if after 18 min. the system has not
reached at the Vac Dip1or Vac Dip2 values during the prevacuum stage. It also appears if the Leak Test program fails.
13 - Jacket not Ready
This message is displayed if the START key was activated
before the jacket reached the desired pressure.
21 - Door1 Safe Switch
If, while closing, Door #1 of an automatic sliding door, the
door safety bar feels resistance, the door will open, and this
message will appear.
22 - Door2 Safe Switch
If, while closing, Door #2 of an automatic sliding door, the
door safety bar feels resistance, the door will open, and this
message will appear.
4.2 Description of Displayed Messages and Safety Measures
MAN205-0195042EN Rev. A Aug. 2011
Page 42 of 137 pages
Page 49
23 - Door1 Gasket Low
Vacuum
This message indicates that during opening Door #1, you do
not achieve the proper vacuum in Gasket1.
24 - Door2 Gasket Low
Vacuum
If whilst opening Door #2 you do not achieve the proper
vacuum in Gasket2.
25 - Vac Res. Empty
This message is a result of a safety mechanism indicating
that if during the pre-vacuum stage, drying stage, vac. test or
leak test it is revealed that the lower float switch in the
vacuum water reservoir is open for more than 1 second (so
there is no water entering the water reservoir and the pump
has therefore been closed to protect it).i.e. Vfloat –L = ―1‖
27 - First Close Door
This message appears if there was an attempt to perform
IN/OUT Test while the door is open.
Calibration
This message appears on the panel during calibration.
Closing Door Wait
When an automatic door is closing, this message is displayed
so that the operator waits until the closing operation of the
automatic door is completed.
Open Door Wait
When an automatic door is opening, this message is
displayed so that the operator waits until the opening
operation of the automatic door is completed.
Door1 Open
This message appears when Door1 is open. It will also
appear if the door is supposedly closed but there is not
enough pressure in the gasket to seal it properly.
Door2 Open
This message appears when Door2 is open. It will also
appear if the door is supposedly closed but there is not
enough pressure in the gasket to seal it properly.
Door 1 & 2 Open
This message appears when both doors are open.
Under Test
This message appears on panel 2 during the IN/OUT Test
and during Setup.
Informative Messages
MAN205-0195042EN Rev. A Aug. 2011
Page 43 of 137 pages
Page 50
Above the left key (F1)
Show
Above the middle key (F2)
Option
Above the right key (F3)
Open
4.3 Operating the Control Panel
4.3.1 Starting Up the System
After turning ON the system, the following screen is displayed for a few seconds:
After a few seconds the Stand By screen is displayed.
This is the central screen from which all operations are performed.
It is also the ―Ready‖ screen from where all cycles can be started, when relevant conditions
are met.
If the system is ready the display appears as follows:
If the system is not ready it will not allow you to start a cycle.
If, for example, Door1 is open when the system is turned ON, the display will warn the
operator of this in the 3rd row of the display allocated to messages, and the following screen
appears:
The 3 command keys on the Stand By screen are:
MAN205-0195042EN Rev. A Aug. 2011
Page 44 of 137 pages
Page 51
4.3.2 Selecting a Cycle
A cycle can only be selected in Stand By from the Stand By / Ready screen which
displays the cycle number and name in the top row.
To select a cycle:
1. Press the UP/DN keys to change the cycle where pressing UP moves to the
next program and pressing DOWN moves to the previous program.
2. Press on a number; press key 4 to select program 4
Selecting a 2 digit cycle:
For programs with double digits (for program 10 or above), both numbers are to be
pressed within 2 seconds of each other. For example, to choose program 12, number 1
must be pressed, and within 2 seconds number 2 must be pressed.
Show Parameters
After selecting the cycle, when pressing the SHOW command key the following screen
is displayed:
The message displayed in the 3rd row describes the following:
The temperature; the sterilization temperature
The time; the sterilization time
D-Time; drying time.
This screen is displayed for 10 seconds after which it automatically returns to the ST.BY
screen.
This command key is not active for cycle 12 – Leak Test.
MAN205-0195042EN Rev. A Aug. 2011
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Page 52
Running a Cycle
Before starting a cycle, make sure to check the following:
Select the steam source.
If the building steam source is supplying enough steam to operate the
autoclave. If not, use the internal steam generator. See ―Switching to
the Steam Generator‖ section in the ―Operating Instruction section.
There is enough steam pressure in the jacket.
There is enough air pressure for the pneumatic valves.
The door is closed.
There is enough distilled or mineral free water for the steam generator.
There is enough water in the vacuum pump water reservoir.
When the SETUP has been checked and the display is in the Stand By /Ready mode,
press START to run the cycle; the RUN LED lights up and the cycle is in progress.
At the end of the cycle, the LED switches OFF, and the appliance is in the Stand By
mode.
Powering ON the Reset Test
1. Turn ON the appliance.
2. Check that all the valves and outputs, including LEDs on the panel are turned
OFF.
3. Check the last illumination of the panels is turned ON.
4. Check the message – Wait!!! Version = (version name) appears on the 2
panels with the correct version.
5. Select two-digit program numbers by pressing each digit-key within 2 seconds
of each other.
6. Check that the two LEDs on each panel are turned OFF, the message deleted
and the system moves to into the Stand By Mode.
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In/Out Test – Design:
The system contains a stage called In/Out Test Stage. This includes all the required
elements for the In/Out Test.
The test includes:
Testing all the outputs. Each output is turned ON one at a time. The
output passes to ‗ON‘ for a maximum time of 15 seconds or until the
UP key is pressed.
The command begins from output number 1 until 24.
Testing of all the digital inputs should take a maximum time of 15
seconds for each input. When the input is found in ―0‖ it will show ‗ON‘
on the screen. When the input is in ―1‖, it will show ‗OFF‘ on the screen.
All the analog inputs will be displayed on the screen without a filter. As
such, it will be able to calibrate them at the time that the display is on
the screen via the PC.
At the end of the stage, it will allow the In/Out Test to start afresh or to
exit. When exit is chosen, the system will initialize.
Inputs for the In/Out Test require a code.
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Testing the In/Out Routine
1. Turn ON the system.
2. Press the OPTION key. The right command key will be called In/Out.
By pressing on this key, the screen displays:
Code:
3. Enter In /Out Test
Code:
4. Enter the code 2ØØ7.
The screen will display the message ‗Digital Ø1 On!!!‘ Be sure that OUTØ1 is ON.
5. Press on ‗UP‘, the screen displays the message ‗Digital OUTØ2 ON!!!‘
Ensure that OUTØ2 is ON.
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4.3.3 System Setup (Changing Parameters and Values)
Note:
The system allows 15 seconds for values to be entered. If this time passes and
the panel has not been touched, the display will automatically move to the next
screen.
When codes are not entered within 15 seconds, the RUN and FAIL LEDs light
and the display returns to WAIT and then to the Stand BY screen.
If the code is incorrect the above will also occur.
When the display shows ØØØØ and a single value (between1-9) is to be
entered, the Ø must be pressed first. The single value cannot be entered on its
own; for example, to enter the number 4, the value is entered by pressing the
Ø three times and then the number 4.
When a value is to be entered, the right command key is ENTER:
If the value is entered via the digital key, after the final digit is entered, the
system automatically moves to the next screen, and ENTER need not be
pressed.
If the value is entered using the UP/DN keys, ENTER must always be pressed
to progress to the next screen.
The system setup includes the following functions:
Clock – Date and Time, Language, Number of Doors, Door Type and Atmospheric
Pressure
To check that the system has correctly been set, press the OPTION key on the ST.BY
screen.
The screen displayed is as follows:
Press the SETUP key. The system requests a code.
Enter the code and the display automatically moves to the next screen after the last digit
is entered.
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English
Ø
German
1
French
2
Spanish
3
Clock
The clock first displays the date and then the time.
Date
The date is always displayed as day/month/year.
Press the UP/DN keys to change the value.
1. Press ENTER (the right command key), after selecting the desired value to
move on to the next value, i.e. the 'day value' will be underlined.
2. Press the UP/DN keys to change the value and ENTER. The 'month value' will
be underlined and the process continues.
3. To change the 'year value' to ØØ, keep pressing the DOWN key until you get
to Ø, press ENTER.
If no changes are to be made, continue pressing ENTER to skip to the next step. After
entering the 'year value', when ENTER is pressed, the display changes to the Time
display.
Time
Time is always displayed in hour/min/sec.
When entering the screen, the 'hour value' is underlined.
Press the UP/DN keys to change this value.
Press ENTER (the right command key), to move on to the 'minute value'.
Continue the process until the time is correct.
If no changes are to be made, press ENTER to move on to the 'second value'.
Pressing ENTER after the 'second value' has been changed automatically skips to the
next screen – the Language screen.
If there are no changes to be made, continue pressing ENTER until the Language
screen is displayed.
Language (Option)
4 popular languages have been specified with Latin letters only: English, German,
French and Spanish.
This screen is relevant if using different languages.
The right command key is ENTER.
If English is being used, leave the code at Ø and press ENTER to move on to the next
screen – Doors Number.
If the language requires to be changed, press the appropriate number as specified
below and then press ENTER.
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Doors Number
After entering the language, the following message is displayed:
This autoclave has two door, press ØØØ2. Press ENTER, and the system moves to the
next screen.
Door Type
There are 3 different types for autoclaves – Manual Door, Automatic Hinged Door, or
Automatic Sliding (horizontal or vertical) Door.
In this autoclave, the doors are Vertical sliding doors; the door type is (ØØØ2). Enter
these values either through the UP/DN keys and then press ENTER, or enter the digits
whereby the screen will automatically progress to the next display after entering the
fourth digit.
Atmospheric Pressure
The standard atmospheric pressure at the sea level is 100 kPa and for every 100m
above sea level the atmospheric pressure drops by 1kPa, and for every 100m below sea
level the atmospheric pressure increases by 1kPa. For example, at an altitude of 2500m,
the Atmospheric Pressure will be 75 kPa.
(The standard atmospheric pressure at Sea Level is 14.5psi. For every 1000ft. above
sea level, the atmospheric pressure drops 0.45psi, and for every 1000ft below sea level,
the atmospheric pressure increases 0.45psi.)
When a door of the autoclave is open then set Atm. Pres. The parameter entered into
the program memory will serve as reference for correct pressure control and monitoring.
If pressure is set correctly, then press ENTER and the next screen appears. If pressure
needs to be altered, this may be done either through the digital key or the UP/DN keys.
F – 0 Mode
This mode enables F – 0 calculations, the processing being based on data fed by two
temperature sensors. One mounted in chamber and one on the condensate pipeline.
The F - 0 calculations is performed for cycles with sterilization temperatures in the range
of 101ºC–134ºC (215ºF - 273ºF), especially used in programs 8–10.
F – 0 = 0 (unable)
F – 1 = total heating time + total cycle time + cooling time.
F – 2 = compensate the difference between heating time, cooling time and exhaust.
Calculates using factor 1.5 of the total accumulated heating and cooling time and
converts that into the equivalent sterilization time.
Temp F – 0 = determines the temperature at which F – 0 calculations should begin.
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Entry code
1
Resolution
1º
Minimum value
105ºC (221 ºF)
Maximum value
137ºC (278 ºF)
Entry code
1
Resolution
1 minute
Minimum value
1 minute
Maximum value
99 minutes
Entry code
1
Resolution
1 minute
Minimum value
Ø minutes
Maximum value
99 minutes
4.3.4 Changing Cycle Parameters
The screen that allows for parametric changes appears as follows:
1. Press CLEAR or ENTER before entering the code to return to the Stand By
screen; the RUN & FAIL LEDs are lit.
2. Enter the correct code via the UP/DN keys.
3. Press ENTER to proceed to the next screen.
4. Press the UP/DN keys to change all parametric values.
Cycle Setup Parameters
CODE 1 OR 11 PARAMETERS
STE Temp – Required sterilization temperature for the process
STE Time – Required sterilization time for the process
Dry Time – Required drying time for the process
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Entry code
11
Resolution
1 minute
Minimum value
20 minutes
Maximum value
60 minutes
Entry code
11
Ex Mode
Fast Ex
1
N.A.
2
Slow Ex. (waste)
3
Slow Ex. (liquids)
4
Cooling with compressed air
5
Cooling with water circulation
6
Entry code
11
Resolution
1º
Minimum value
40ºC (104ºF)
Maximum value
137ºC (278ºF)
Entry code
11
Resolution
1
Minimum value
1
Maximum value
10
Entry code
11
Resolution
1 kPa (0.1 psi)
Minimum value
1 kPa (0.15 psia)
Maximum value
75 kPa (10.8 psia)
Heat T.O. – Maximum time for heating the chamber for starting sterilization
When the duration of the heating stage is longer than Heat T.O., the program will stop
and display the message ‗Low Heat‘.
Ex Mode – The method for exhausting the steam at the end of the process
EndTemp – Ending Temperature (Exhaust Stage)
Defines the temperature at which the process ends for opening the door.
PulsNum. – No. of pulses in the pre-vacuum stage
VacDip1 – Vacuum value in the first pulse
Defines the vacuum value in pulse No.1 of the pre-vacuum stage
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Entry code
11
Resolution
1kPa (0.1 psi)
Minimum value
1kPa (0.15 psia)
Maximum value
75kPa (10.8 psia)
Entry code
11
Resolution
1 second
Minimum value
3 seconds
Maximum value
1800 seconds (30
minutes)
Entry code
11
Resolution
1 second
Minimum value
3 seconds
Maximum value
1800 seconds (30
minutes)
Entry code
11
Minimum value
Ø second
Maximum value
90 seconds
VacDip2 – Vacuum value in the remaining pulses
This value defines the vacuum in the remaining pulses in the pre-vacuum stage (not just
pulse no. 2)
VacTime1 – Waiting time in the first pulse
In the pre-vacuum stage, in the first pulse after arriving at VacDip1, there is a waiting
time known as VacTime1 (in seconds).
This delay occurs so that air removal and vacuuming can continue.
VacTime2 – Waiting time for the remaining pulses
For the remaining pulses (following pulse no.1) in the pre-vacuum stage, after arriving at
the VacDip2 stage there is a time delay known as VacTime2 (in seconds).
WtrTime – Time for entering the water into the generator after the electrode
touches the water.
This value defines the time (in seconds) during which the water pump continues to work
and enter water to the steam generator after the upper electrode touches water.
This is done to prevent a situation where right after the electrode touches water, the
pump immediately stops operating.
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Entry code
11
Resolution
1 kPa (0.5 psi)
Minimum value
ØkPa/psia
Maximum value
30 kPa (4.35 psia)
Entry code
11
Resolution
5 kPa (1 psi)
Minimum value
100 kPa (14.5 psia)
Maximum value
300 kPa (44 psia)
Entry code
11
Resolution
5 kPa (1 psi)
Minimum value
100 kPa (14.5 psia)
Maximum value
300 kPa (44 psia)
Entry code
13
Resolution
1 kPa (0.1 psi)
Minimum value
2 kPa (0.1 psia)
Maximum value
20 kPa (4 psia)
LimitP add – Adding pressure to the maximum pressure
This value defines the addition to the maximum pressure, computed to the jacket
control.
For example, when the desired temperature is 134ºC (273ºF) the maximum
temperature maintained in the jacket will be adjusted to a temperature of 137ºC (i.e.
332kPa) - 278 ºF (48 psi)
When this pressure is not enough, it can be increased by changing the values of the
LimitP add.
If the parameter value remains Ø, the maximum pressure in the jacket will be 332kPa,
however if this value will be 10, the maximum pressure will be 342kPa.
PulsPres1 – The pressure in pulse no.1 in the pre-vacuum stage
This defines the first pulse pressure in the pre-vacuum stage. If it is defined as 100kPa,
the system will not enter steam into the chamber, however; the vacuum pump will
immediately start operating to create a vacuum.
If the value is defined over 100kPa, the system will open the steam valve to the chamber
until the desired pressure is reached.
PulsPres2 – The pressure in pulse 2 and onwards in the pre-vacuum stage
After the completion of pulse no.1, the system will enter steam by the defined value in
pulse press.
CODE 13 - PARAMETER
ReqPrs+ - The addition to the required pressure for sterilization
This parameter sets the pressure point maintained during the sterilization stage in the
following manner:
If the desired temperature is 134ºC (273°F), the required pressure (from the tables) is
305kPa (44.2 psi).
When the ReqPrs+ is Ø, the system pressure will be maintained at 305kPa (44.2
psi)during the sterilization stage. When the Reqprs+ equals 5kPa (0.5 psi), the system
will be maintained at 310kPa (44.9 psi) in the sterilization stage. It is advised to work
with a value of 7kPa (0.5 psia).
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Entry code
13
Resolution
1
Minimum value
1
Maximum value
5
Entry code
11
Resolution
1 minute
Minimum value
Ø minute
Maximum value
15 minutes
Entry code
11
Resolution
1 (Mode)
Minimum value
Ø
Maximum value
90
Entry code
33
Resolution
1 (Mode)
Minimum value
Ø
Maximum value
1
Entry code
33
Resolution
1 (Mode)
Minimum value
Ø
Maximum value
1
Select PT100
There are 2 temperature sensors that regulate cycles:
1. Sensor 1: (double) in the condensate line: PT100 – No. 1
2. Sensor 5: in the drain line PT100 – No 5
This is the final parameter under Code 13. Pressing ENTER returns the display to the
ST.BY screen.
Stay Time - Delay time between heating and sterilization
This parameter allows partial entry to the sterilization stage with a reduction of the
overshoot and the reduction difference between the different sensors that are entered
into the chamber for control or validation.
In the Heating Stage the system will stop heating before entering Sterilization according
to the STAY TIME value. When this value is set to 2 minutes, the system will stop 2ºC
before entering sterilization and will proceed at a rate of 1ºC/min during the STAY TIME.
This is the final parameter under Code 11. After pressing ENTER the display will return
to the ST.BY screen
Dry Vac. - Dry Vac. =0;
Bio Cycle
Air Detector
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4.3.5 Door Display Function
(Applicable only for automatic doors)
Displays when Opening or Closing the Doors
Opening an Automatic Door
While an automatic door is opening, the message OPENING DOOR – WAIT appears in
the 3rd row.
Closing an Automatic Door
While an automatic door is closing, the message CLOSING DOOR – WAIT appears in
the 3rd row.
If the pressure in the chamber is higher than 115 kPa (2.7 psig), the door will not open.
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4.3.6 Display During a Cycle
Display during the Pre-Vacuum Stage
When the cycle passes to the Heat stage the steam enters the system, in place of
‗PUMP TO 25K‘, it will display ‗HEAT TO 160K‘.
When the cycle passes to the Exhaust stage,‘ it will display ‗EXH TO 100K‘.
Display during the Heating Stage
Display during the Sterilization Stage
Display during the Drying Stage
Help:
If at any stage there is a problem, you can turn the system can be OFF at the power
switch. Turn ON the power again while pressing STOP till you hear a long buzz. After
loading, the screen lights with the message below.
The display returns to the ST.BY screen and you can continue.
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5. PRINTER
5.1 Printer Output
The autoclave is equipped with a character printer, which prints a detailed history of
each cycle performed by the instrument (for the record or for subsequent consideration).
The printing is made on plain paper with 24 characters per line and contains the
following information:
Software version
Real time
Selected program
Sterilization pressure
Sterilization temperature
Sterilization time
Summary of performed cycle and identification hints.
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 below.
The data is printed from the bottom up, beginning with the date and ending with ―O.K.‖
for a complete cycle or ―FAIL‖ for an aborted cycle.
For an example of a typical printout, see next page.
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PRINTER OUTPUT
DESCRIPTION
Autoclave 1102058
Autoclave serial no.
Name : __--------
Name of the operator to be filled in .
Load #: 0030
30/08/2011 13:45:16
Date and time the cycle ended
E13: 31 099.7ºC 049.5k
The time, temperature and pressure during
exhaust stage.
F11:30 134.2ºC 306.8k
If cycle fails, conditions at time of failure.
CYCLE FAILED! ! !
Message displayed if cycle fails.
Manual Stop - 03
If operator presses the manual stop button.
H11:28 099.9ºC 26k
The time, temperature and pressure during
sterilization.
H10:08 134.3ºC 315.1k
The time, temperature and pressure during the
heating stage.
H06:04 132.3ºC 304.1k
The time, temperature and pressure during the
heating stage.
H02:00 116.2ºC 217.3k
The time, temperature and pressure during the
heating stage.
H03:00 080.6ºC 023.1k
The time, temperature and pressure during the
heating stage.
V00:27 078.3ºC 048.7k
The time, temperature and pressure during air
removal (vacuum).
Exhaust mode: 1
Exhaust mode: fast exhaust and process ends..
Dry time : 001 min
Drying time of the selected program
Ster time: 001.0 min.
Preset sterilization time of the selected program.
Ster Temp: 134ºC
Sterilization temperature in chamber for selected
program.
Cycle: 01 Unwrap
Selected program: Unwrapped Instruments.
30/08/2011 13:29:31
Date/month/year time/min./sec.
Version = Horiz En3M3 Spn
Number and version of the software program.
Legend
V - Air removal stage
S - Sterilization stage
F - Fail
E - Exhaust stage
H - Heating stage
D – Drying stage
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5.2 Printer Handling
Setting Paper
1. Press the paper cover open button, and open the paper cover. Handle the
paper cutter carefully not to cut your hand.
2. Set a paper roll as shown in the figure.
3. Close the paper cover by pressing both ends of the cover with the tip end of
the paper emerging from the cutter.
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.
Test points
In the test print mode, characters printable with the printer (ANK, KanJi) and bar code
are outputs. Turning power ON with the FEED IN signal kept low triggers the test print.
Caution!
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.
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Power OFF the printer in any of the following cases:
The printer does not recover from an error.
Smoke, strange noises or smells erupt from the printer.
A piece of metal or any liquid touches the internal parts or slot of the printer.
Notes on treatment of 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.
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Cycle no.
Program
Temp ºC
1, 2, 3
Un-wrapped
134
4, 5, 7
Wrapped
134 6 Wrapped
121
8, 9, 10
Slow exhaust
121
11
B&D test
134
12
Leak test
—
6. STERILIZATION PROGRAMS
6.1 Program Descriptions
The autoclave is equipped with 12 programmable sterilization programs and two test
programs. The test programs are pre-set by the manufacturer in such a way, that their
parameters are not changeable.
Following are the names, relevant programs with related temperatures of the 12
sterilization cycles and 2 test programs.
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0 kPa
25 kPa
50 kPa
100 kPa
104°C/ ~115 kPa
134°C/ ~305 kPa
160 kPa
121°C/ ~205 kPa
134°C 3 min
Ex Mode 1
1 min
Program 1, 2, 3 for Un-wrapped goods 134ºC (process Sample)
These programs are intended for un-wrapped rigid items, for example instruments and
other goods, which their manufacturer declares their compliance to be sterilized in the
following conditions:
Sterilization temperature 134ºC
Sterilization time 3 minutes
Dry time 1 minute
Performance Description:
Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. The 4th vacuum pulse is followed by the introduction of saturated (controlled)
steam into the chamber to the required sterilization temperature.
Sterilization is controlled in a way that the sterilization temperature will not drop below
the required temperature nor increase by more than 3ºC. The steam conditions are
controlled in such a way that the fluctuation of pressure does not allow a drop below 1
kPa, nor an increase over 3 kPa, above the high limit of the Ste. Temperature.
Fast exhaust is performed by rapidly discharging the pressure from the chamber. The
vacuum pump is activated to create a vacuum in the chamber for drying.
Drying is achieved by evacuating the vapors from the chamber in an "under pressure"
phase for a period of 1 minute.
Pressure equilibrium enables the opening of the door. Air is introduced into the
chamber through a microbiological filter until equilibrium is reached with atmospheric
pressure.
Important:
In order to obtain good sterilization results, dry time is essential.
Note:
The pressure must be below 115 kPa to enable the door to be opened.
Caution!
Care should be taken to preserve the sterility of un-wrapped instruments
in a non-sterile environment.
Program 1, 2, 3 for Un-wrapped goods 134ºC (Process Sample)
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0 kPa
25 kPa
50 kPa
100 kPa
104°C/ ~115 kPa
134°C/ ~305 kPa
160 kPa
121°C/ ~205 kPa
134°C 7 min
Ex Mode 1
15 min
Program 4, 5, 7 for Wrapped goods 134ºC (Process Sample)
These programs are intended for wrapped goods, for example instruments and other
goods, which their manufacturer declares their compliance to be sterilized in the
following conditions:
Sterilization temperature 134ºC
Sterilization time 7 minutes
Drying time 15 minutes
Performance Description:
Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. The 4th vacuum pulse is followed by the introduction of saturated (controlled)
steam into the chamber to the required sterilization temperature.
Sterilization is controlled in a way that the sterilization temperature will not drop below
the required temperature nor increase by more than 3ºC. The steam conditions are
controlled in such a way that the fluctuation of pressure does not allow a drop below 1
kPa, nor an increase over 3 kPa, above the high limit of the Ste. Temperature.
Fast exhaust is performed by rapidly discharging the pressure from the chamber. The
vacuum pump is activated to create a vacuum in the chamber for drying.
Drying is achieved by evacuating the vapors from the chamber in an "under pressure"
phase for a period of 15 minutes.
Pressure equilibrium enables the opening of the door. Air is introduced into the
chamber through a microbiological filter until equilibrium is reached with atmospheric
pressure.
Important:
In order to obtain good sterilization results, dry time is essential.
Note:
The pressure must be below 115 kPa to enable the door to be opened.
Program 4, 5, 7 for Wrapped goods 134ºC (Process Sample)
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0 kPa
25 kPa
50 kPa
100 kPa
104°C/ ~115 kPa
134°C/ ~305 kPa
160 kPa
121°C/ ~205 kPa
121°C 15 min
Ex Mode 1
15 min
Program 6 for Wrapped goods 121ºC (Process Sample)
This program is intended for wrapped goods, for example instruments and other goods,
which their manufacturer declares their compliance to be sterilized in the following
conditions:
Sterilization temperature 121ºC
Sterilization time 15 minutes
Drying time 15 minutes
Performance Description:
Residual air is displaced by 4 vacuum pulses (down to 25 kPa) and 3 steam pulses up
to 160 kPa. The 4th vacuum pulse is followed by the introduction of saturated (controlled)
steam into the chamber to the required sterilization temperature.
Sterilization is controlled in a way that the sterilization temperature will not drop below
the required temperature nor increase by more than 3ºC. The steam conditions are
controlled in such a way that the fluctuation of pressure does not allow a drop below 1
kPa, nor an increase over 3 kPa, above the high limit of the Ste. Temperature.
Fast exhaust is performed by rapidly discharging the pressure from the chamber. The
vacuum pump is activated to create a vacuum in the chamber for drying.
Drying is achieved by evacuating the vapors from the chamber in an "under pressure"
phase for a period of 15 minutes.
Pressure equilibrium enables the opening of the door. Air is introduced into the
chamber through a microbiological filter until equilibrium is reached with atmospheric
pressure.
Important:
In order to obtain good sterilization results, dry time is essential.
Note:
The pressure must be below 115 kPa to enable the door to be opened.
Program 6 for Wrapped goods 121ºC (Process Sample)
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0 kPa
25 kPa
50 kPa
100 kPa
104°C/ ~115 kPa
134°C/ ~305 kPa
160 kPa
121°C/ ~205 kPa
121°C 15 min (30 min for Prog. 10)
Ex Mode 4
Program 8, 9, 10 – Slow Exhaust 121ºC (Process Sample)
These program are intended for the sterilization of liquids which require a slow pressure
exhaust which comply with their manufacturers declares their compliance to be sterilized
in the following conditions:
Sterilization temperature 121ºC
Sterilization time 15 minutes (30 minutes for program 10)
Slow discharge of the pressure.
Performance Description:
Residual air is displaced by 1 vacuum pulse (down to 25 kPa). The vacuum pulse is
followed by the introduction of saturated (controlled) steam into the chamber to the
required sterilization temperature.
Sterilization period is controlled in a way that the sterilization temperature will not drop
below the required temperature, neither will it increase by more than 3ºC. The saturated
steam conditions are controlled in such a way that the fluctuation of pressure does not
allow a drop below 1 kPa, nor an increase of 3 kPa above the high limit of the Ste.
Temperature.
Slow exhaust is performed by discharging the pressure very slowly from the chamber.
Pressure equilibration enables the opening of the door. Air is introduced into the
chamber through a microbiological filter until equilibrium is reached with atmospheric
pressure.
Note:
The temperature of the chamber must be below the end sterilization temperature
in the range of 60ºC - 100ºC, and the pressure must be below 115 kPa to enable
the door to be opened.
Important:
Because of the difficulty to standardize the liquid cycle load, this cycle is
not intended for sterilization of materials that come into contact with
patients, and should be used for non-clinical applications only.
Program 8, 9, 10 – Slow Exhaust 121ºC (Process Sample)
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0 kPa
25 kPa
50 kPa
100 kPa
104°C/ ~115 kPa
134°C/ ~305 kPa
160 kPa
121°C/ ~205 kPa
134°C 3.5 min
Ex Mode 1
2 min
Program 11 Bowie & Dick Test
This program is intended to test residual air in the chamber. The parameters are locked
in such a way that they cannot be changed. These are the parameters:
Sterilization temperature 134ºC
Sterilization time 3.5 minutes
Drying period of 2 minutes
The Bowie & Dick test pack should be placed horizontally on the bottom of the loading
rack, near the door and over the drain.
Press 1 and 1 again within 2 seconds of each other. This selects cycle "11" Bowie &
Dick test. Press START to run the test. This is a pre-programmed and cannot be
changed.
Performance Description:
Residual air is displaced due to 4 vacuum pulses (down to 25 kPa) and 3 steam pulses
up to 160 kPa. The 4th vacuum pulse is followed by bringing saturated steam into the
chamber to the required sterilization temperature.
Sterilization period is controlled so that the sterilization temperature will not drop
bellow the required temperature, nor will it increase by more than 3ºC. The saturated
steam conditions are controlled in such a way that the fluctuation of pressure will not
drop below 1 kPa, not will it increase above 3 kPa above the high limit of the Ste.
Temperature.
Fast exhaust stage is performed by discharging rapidly the pressure from the chamber.
The vacuum pump is activated to create a vacuum in the chamber for drying.
Drying is achieved by evacuating the vapors from the chamber in an "under pressure"
phase for a period of 2 minutes.
Pressure equilibration enables the door to be opened. Air is introduced into the
chamber through a microbiological filter until equilibrium is reached with atmospheric
pressure.
Important:
In order to obtain good sterilization results, dry time is essential.
Note:
The temperature of the chamber must be below 110ºC and the pressure must
be below 115 kPa to enable the door to be opened.
Pass/Fail step
Remove the hot test pack from the autoclave carefully.
When using the B& D test pack, or any other PCD, (Process Challenge Device),
observe the following: The color shall be a uniform black. If the color is not
uniform black the verification should be ejected and notify your authorized
Tuttnauer technical representative for service.
Program: 11- Bowie & Dick Test
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0 kPa
25 kPa
50 kPa
5 min
10 min
100 kPa
Program 12 "Air Leakage Test”
This program is intended to test air leakage to the chamber, through the door seal or any
other seals.
This test is performed during the vacuum phase.
Press number 1 and then number 2 within two seconds, to select cycle 12 -Air Leakage
test.
Press START to automatically run the pre-programmed AAMI air leakage cycle
parameters.
At the end of the cycle, the unit printer will print "PASS" or "FAIL" on the tape printout.
In the event of test failure, repeat the test. In case of repeated test failure, notify your
authorized Tuttnauer technical representative.
Performance Description:
A vacuum is drawn in the chamber down to 18 kPa. At this stage all valves and motors
are closed. A period of 5 minutes is counted to enable stabilization of pressure. During
the next 10 minutes the pressure is monitored.
The acceptable change of pressure during these 10 minutes is 1.3 kPa.
Program: 12- Air leakage test
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7. PREPARATION BEFORE STERILIZATION
Note:
Liquids can only be sterilized in an autoclave with two temperature sensors in the
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. Wash instruments immediately after use, to dispose of any residue.
2. Before placing an instrument into the sterilizer, make sure that the instruments
which are not of the same metal (stainless steel, carbon steel, etc.) are
separated.
Note:
Check manufacturers' instructions for sterilization of each item.
3. In case carbon steel instruments are used with stainless steel trays, the tray
should be lined with a towel or paper wrap before placing the instrument.
There should be no direct contact between the carbon steel and the stainless
steel trays.
4. All instruments must be sterilized in an open position.
5. Place a sterilization indicator strip in each tray.
6. Once a week use a biological spore test indicator in any load to ensure
sterilization.
7. Make sure that all the instruments remain apart during the sterilization cycle.
8. Empty canisters should be placed upside-down in order to prevent
accumulation of water.
9. Do not overload sterilizer trays. Overloading will cause inadequate sterilization
and drying.
10. Allow a distance of approximately 2.5 cm (1") between trays to permit
circulation of steam.
11. Wrapped instruments should be packed in material which promotes drying,
such as autoclave bag, autoclave paper and muslin towels.
Attention
Verify that the packaging method is in accordance with good practice approach
and the packaging materials are in accordance with the applicable standards (e.g.
EN868 series).
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The following is recommended:
Tubing
Rinse tubing after cleaning with pyrogen free water. When placing in tray, ensure that
both ends are open, without sharp bends or twists.
Packs
Place packs upright on trays, side by side.
Packs should not touch the chamber walls.
Sterilization in slow discharge of pressure
Use only heat-proof glass, filled 2/3 full.
Ensure that the glass container is covered but not sealed to prevent pressure build-up.
7.1 Loading
Note:
Liquids can only be sterilized in an autoclave with two temperature sensors in the
chamber.
Every machine is supplied either with two (or more) stainless steel shelves, or with rails
for loading cart from a transfer carriage.
The transfer carriage is made of stainless steel and comes with adjustable legs to
balance the height of the loading cart to the rails in the sterilizer chamber. The loading
cart is designed to slide smoothly off the carriage into the sterilization chamber.
The carriage moves on four heavy-duty castors, which are mounted on its base. The two
castors on the rear of the carriage are equipped with brakes. When the transfer carriage
is put in position for loading or un-loading the cart from the autoclave, the brakes must
be applied. Two spring loaded securing hooks are mounted on the front. The hooks hold
the carriage firmly to the autoclave during loading or un-loading of the loading cart.
Caution!
It is strictly forbidden to load or un-load the loading cart, if the transfer carriage is not
connected by the hooks to the autoclave, and the brakes are not applied.
When loading the materials to be sterilized into the chamber, observe the rules
described in this chapter.
Do not overload the loading cart or the shelves as this can have adverse effects on the
results of the sterilization and drying. Leave space between the packs or wrapped
instruments to allow complete removal of air pockets in the air removal stage, and for
free penetration of steam in the heating and sterilization stages.
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Transfer Carriage
Loading Cart
Hooks release handle
Securing hooks
7.2 Un-loading
1. When the buzzer signals the successful completion of a cycle, open the door
and let the load cool down for several minutes.
2. Hook the transfer carriage firmly to the autoclave, apply the brakes, and roll the
loading cart out of the chamber.
3. Once the loading cart is firmly on the transfer carriage and locked into place,
release the hooks and the brakes, and take the transfer carriage or the
containers aside to cool down.
4. Allow the load to cool down in an area with minimum passing traffic (to avoid
the possibility of touching the hot load), and without air movement (air
conditioning, etc.). Do not touch the hot load. Hot loads absorb moisture and
may absorb bacteria from a hand.
5. Do not transfer a hot load to metal shelves for cooling. Perform a visual
inspection to ascertain that sterilizing indicators have made the required color
change, and that the load is dry.
The load is to be rejected if:
a. The package has been compressed.
b. The package is torn.
c. The load is wet (water droplets signs).
d. The load fell on the floor.
e. Condense can be observed on the lid.
f. The PCD or other indicator present – Faulty cycle.
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Warning!
During loading and unloading use safety gloves and glasses in accordance with
local safety regulations and good practice.
It is strictly forbidden to enter the autoclave chamber!
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and
unauthorized use.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
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8. OPERATING INSTRUCTIONS
Attention!
Liquids can only be sterilized if there are two PT 100 flexible temperature sensors
in the chamber.
Warning!
Do not operate the autoclave in the presence of dangerous gases and vapors.
Observed the manufacturer recommendations sterilization data for each type of
material.
Observe the manufacturer recommendation sterilization data each type of material.
Starting the autoclave
1. Check that the feed water manual valve is open.
2. Check that the compressed air manual valve is open, and compressed air is
available.
3. Choose the appropriate steam source, and check that the steam inlet manual
valve is open.
4. If the internal generator is to be used, check the generator is connected to the
electrical supply and working properly. See ―Operation & Maintenance manual‖
for starting and operating the steam generator.
5. Power the autoclave by turning ON the main power switch.
6. Observe the gauge and see, that the generator reaches working pressure.
7. Check that the jacket pressure gauge, reaches 2.4 bar (35 psi).
Running a sterilization program
1. Open the door by pressing the F3 key (the right button on the row below the
display); the word "OPEN" appears on the lower row of the screen indicating
that the door can be opened. The message "OPENING DOOR – WAIT" is
displayed on the third row. The door slides down to the lowest position.
2. Load the sterilizer.
3. Close the door by pressing the F3 key, when the word "CLOSE" appears in the
lower row of the screen the door is lifted until being locked and the chamber is
sealed. While the door is closing the message "CLOSING DOOR – WAIT" is
displayed in the third row and the word "READY" appears in the first row,
indicating autoclave is ready to start operation.
4. Select the required program, then press START.
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Note:
When a sterilization program is running, the LED RUN lights up on the control
panel.
5. At the end of the cycle a buzzer sounds and the word "END" is displayed.
Press STOP to cancel the buzzer. Open the door by pressing the F3 key while
"OPEN" is displayed above this key.
6. Take out the sterilized material from the chamber following the steps
mentioned in the ‗Un-loading‘ paragraph.
8.1 Failed Cycle
In case of failed cycle or manual stop by operator, the two LED's RUN and FAIL are lit.
The reason for failure is displayed on the screen. At the end of the cycle an interrupted
sound is heard. Press the STOP key to cancel the alarm.
1. Press STOP.
2. Solve the problem.
3. Log the displayed message in the autoclave log book or any other appropriate
document.
4. If you cannot solve the problem, turn OFF the autoclave and call for service.
Note:
Verify that the pressure in the chamber is atmospheric pressure. Do not attempt
to open the door if the pressure in the chamber is above atmospheric pressure.
If cycle failed, the front door only can be opened.
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8.2 Aborting a Cycle
1. Press the STOP key; the autoclave automatically goes through a shut down
sequence. The unit will either open the drain valve to remove pressure form
the chamber or open the vacuum break valve, depending upon the phase of
the cycle.
2. The autoclave will signal the operator that the cycle has been aborted and will
advise the operator when the door can be opened. (see above)
Note:
When a power failure occurs, the autoclave holds the cycle at that point where
the power was lost. The system stays in the locked down safe mode until the
power is restored. At the power restoration the controller follows the abort
sequence described above.
After aborting a cycle, the front door only can be opened.
CAUTION!
DO NOT ATTEMPT TO OPEN THE DOOR UNTIL NOTIFIED THAT THE ABORT
SEQUENCE IS COMPLETE. IF THE CONTROLLER DOES NOT INDICATE THAT
THE SEQUENCE IS COMPLETE, DO NOT ATTEMPT TO OPEN THE DOOR.
CONTACT YOUR TUTTNAUER TRAINED AND CERTIFIED AUTOCLAVE
TECHNICIAN.
DO NOT ATTEMPT TO OPEN THE DOOR IF THE PRESSURE IS ABOVE
ATMOSPHERIC PRESSURE.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
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8.3 Switching to the Internal Steam Generator
If the building steam supply fails:
1. Open the generator electric box, switch ON the 3 Phase circuit breaker with its
Trip Coil, and ensure all the other circuit breakers are ON.
2. Observe the generator pressure gauge is at working pressure, (4.5 bar).
3. Turn OFF Building steam inlet and turn ON Generator inlet steam using the
ON-OFF-ON switch on the front panel of the autoclave.
4. Check that the Jacket pressure gauge, reaches 2.4 bar
5. Continue to work as normal.
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SERVICE INSTRUCTIONS
Warning!
These service instructions are for the use of qualified personnel only! To avoid
electric shocks, do not perform any servicing other than that specified in the
operating instructions unless you are qualified to do so. Refer all servicing to
qualified service personnel.
When servicing the autoclave, and/or opening any service panel, disconnect the
all electrical power supplies to the unit. This is done by switching OFF the main
power supply switch, or by un-plugging the main electrical power supply cords.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
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User
Before each
cycle
1. Clean the strainer at the bottom of the chamber.
2. Verify that the door gasket and the surface that the
gasket is pressed on are clean.
3. Keep the door closed between sterilizing cycles.
Daily
1. Clean the door gasket every day with a soft cloth.
2. Before the first operation of the day, warm up the jacket
for at least 20 minutes with the door closed, even if the
READY LED is lit up.
3. Keep the door closed between sterilizing cycles.
4. Carry out a BOWIE & DICK test at the beginning of
each day after warm up.
5. Drain the compressor tank before starting operation (if
applicable).
6. If sterilizing liquids, clean the chamber at the end of
every day.
7. At the end of the day leave the door open.
8. Inspect the sight glass gauge of the generator for chips,
scratches, cracks, nicks, or any other visible sign of
damage.
User
Weekly
1. Clean the cabinet and door parts, the internal walls of
the autoclave, the shelves and the shelf rails with a soft
cloth and household detergent. Clean the chamber while the autoclave is cold. The detergent shall be
flushed away with water.
If you used tap water, for the final flush use distilled or
mineral-free water.
Caution!
Do not use steel wool or steel brush as this can
damage the chamber!
2. Place several drops of oil on all the door spindles and
pins (if applicable).
3. Drain the generator (if applicable) as follows:
a. Switch OFF the power.
b. Wait until the pressure decreases to 0.5 bar (watch
the pressure gauge).
c. Open the drainage manual valve for a few seconds
till the glass tube becomes empty, and then close the
valve.
d. Drain the water level tube by opening the tube‘s
valve located at the bottom elbow connecting the tube to
the vessel.
4. At the end of the week, or if the autoclave will stand for
a prolonged period, clean the chamber when it is cold,
and leave the door open.
9. MAINTENANCE OF AUTOCLAVE
9.1 Preventive and Periodical Maintenance
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Technician/User
Monthly
On Autoclaves with Automatic Doors
1. Once a month before the weekend, follow these steps:
a. Remove the door gasket, and thoroughly clean the
door gasket groove.
b. Remove any stains or corrosion from the door
gasket groove, and blow out all traces of dirt with
compressed air.
c. Thoroughly clean the door gasket.
d. Leave the door gasket out for the weekend.
e. Before start of day/shift after the weekend, re-place
the door gasket according to the instructions in the
―Replacing the Door Gasket― section.
Technician
Monthly
For Tuttnauer internal steam generators.
1. Press the Test Button on the internal steam generator
electric box.
The Main Circuit Breakers for the heaters will switch
OFF.
Switch On the Main Circuit Breakers for the heaters
Technician
Quarterly
1. Clean water strainers on pipelines while autoclave does
not operate (idle).
2. Verify sewage pipe is not clogged ensuring free
drainage of sewage liquids. It is important that sewage
liquids do not overflow at the working site.
3. Disassemble the steam –traps and clean them. The
cleaning operation requires cleaning of the strainer
inside the steam-trap. This can be done by rinsing and
removing any dirt, which causes blockage.
4. Check the piping connections and tighten where
necessary to avoid leakage.
5. De-scale the generator (if applicable).
6. Verify that the water quality complies with the
requirements as detailed in the Water Quality
paragraph.
7. Check the vacuum pump inlet/outlet for scale build up
and de-scale if necessary.
Technician
6 months
1. Replace the 0.01 air filter
On Autoclaves with Manual Doors
1. Every six months before the weekend, follow these
steps:
a. Remove the door gasket, and thoroughly clean the door
gasket and the groove.
b. Leave the door gasket out for the weekend.
c. Before start of day/shift after the weekend, re-place
the door gasket according to the instructions in the
―Replacing the Door Gasket― section.
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Yearly
1. Perform an overall check of the locking system and
replace worn parts.
2. Check and tighten where necessary the electrical
connections in the electrical board, connection box,
motors, electrical valves, locking device screws and
instrumentation.
3. Clean the electronic control unit, using a vacuum
cleaner.
4. Check the door gasket and replace if damaged.
5. Ensure periodical tests are done on time.
6. Check the steam-traps and replace if worn.
7. Calibrate the control system
8 Validate the applicable cycles
9. Check and verify tight closing of all tightening bolts of
the side guides, as well as top and bottom guides (if
applicable). Replace worn bolts if necessary (on
horizontal or vertical door).
10. Check and verify tight closing of all tightening bolts of
the bronze strips. Replace worn bolts if necessary (on
horizontal or vertical door).
11. Check and verify tight closing of all tightening bolts of
the door guide rail (including the door's wheel). Replace
worn bolts if necessary (on horizontal or vertical door).
12. Check the hydraulic piston including oil level. Check the
hydraulic system for leakage, worn or loose component
(on horizontal or vertical door).
13. Disassemble the door cover, check and tighten all
locking mechanism bolts (on manual or automatic
hinged doors).
14. Check operation of the micros-witches. Verify that they
are placed tightly as required.
15. Check the safety valve. Allow the safety valve to blow
off by letting the pressure increase until it reaches the
working pressure + 10%. This verifies that the safety
valve operates as required and the valve‘s seat is kept
free of mineral deposits.
Note:
Yearly maintenance should always be accomplished
by a trained sterilizer service technician.
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Notes:
1. The procedures done by the ―User‖ referred in the Preventive and Periodical
Maintenance, must be performed by trained personnel only.
2. Keeping the inside of the autoclave clean will lengthen its life and its proper
operation.
3. Ensure the chamber is empty and cold during all cleaning.
4. For all cleaning use ordinary household stainless cleaner, and rinse first with
tap water, and then with distilled or mineral free water.
5. Use only mineral-free water for the steam generator as detailed in the Water
Quality paragraph, (If applicable).
6. Keep the door closed between sterilizing cycles.
7. If you see or hear anything extraordinary, stop using the autoclave and call for
service.
Periodical Tests
1. Once a year calibrate and validate the autoclave.
2. Periodical safety tests (pressure vessel and electricity) shall be
performed by an Authorized Inspector at intervals as required by the
local laws, rules or regulations.
Periodical safety tests should be performed by an authorized inspector at
intervals as required by local law, rules or regulations.
Notes:
Ensure periodical tests are done on time!
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
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9.2 Safety Tests after Repair
Attention!
After every repair or dismantling the enclosure, the autoclave should pass two
electrical safety test by the qualified Service Engineer. The following shall be
performed:
1. Enclosure Leakage Current Test.
Every autoclave should pass this test as follows:
1. Connect the electrical cord to the autoclave.
2. Turn ON the main switch on the right side of the autoclave.
3. Short-circuit the L and N pins on the cord's plug.
4. Connect the Short-circuit pins to the L pole on the Megaohm Tester.
5. Connect the earth pins to the earth pole on the Megaohm Tester.
6. Impose an electrical potential of 500–1000V on the tested autoclave.
The insulation resistance should be at least 2 MΩ.
The test is successful if there was no leakage.
2. Protective Earth Impedance Test
1. Connect the grounding pin of the power cord plug to one pole of an
Ohmmeter.
2. Connect any other metallic part (preferable – the metallic part of the
locking screw) to the second pole of the Ohmmeter.
3. The resistance should not exceed 0.3 Ω.
After performing these tests, the Service Engineer should complete and sign the
Work Order and the Log Book.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
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Symptoms
Possible causes check-ups
and tests
Corrections
1. Control unit not initialize.
No display and lights on the
front panel.
1.1
The control circuit
breaker switched off.
1.1
Check and switch on
the circuit breaker.
1.2
The power switches
on the front panels of
the autoclave or on the
steam generator are
defective.
1.2
Replace the defective
switch.
2. Steam generator does not
operate.
2.1
Water pump defective
or blocked.
2.1
Repair or replace
pump. Replace motor.
2.2
Blocking or low water
pressure in the pump
circuit.
2.2
Adjust water pressure,
ensure a free
circulation of water.
2.3
Circuit breaker trips,
because of overload or
damage.
2.3
Check and remove the
overload or replace
circuit.
2.4
Upper electrode shortcircuited.
2.4
Clean or replace upper
electrode.
2.5
Electronic pressure
switch or measuring
circuits faulty or out of
calibration.
2.5
Check, calibrate
pressure switches or
replace them.
2.6
Lower electrode dirty
or rusted.
2.6
Clean or replace the
electrode.
2.7
Circuit breakers
switched off or
damaged.
2.7
Turn off or replace the
circuit breakers.
2.8
Contactor controlling
the heat up current is
damaged.
2.8
Check the cause and
replace contactor.
2.9
Control system trouble.
2.9
Replace boards.
(G-PROTEC board)
2.10
Solenoid or pneumatic
steam supply stuck or
defective.
2.10
Repair or replace
solenoid or pneumatic
valve.
9.3 General Troubleshooting
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Symptoms
Possible causes check-ups and
tests
Corrections
3. Steam pressure
increases beyond the
control point.
3.1
Pressure switch faulty or
incorrectly set.
3.1
Check, repair or
replace the
pressure switch.
3.2
Contacts at contactor
welded because of short
circuit.
3.2
Check the cause
and replace the
damaged
contactor.
4. The conditioning
phase (pre-vacuum
does not work).
No steam inlet or low
steam pressure.
4.1
Check if the trouble is due to
pump or its electrical supply
circuit.
4.1
See solutions
indicated in par. 2.
4.2
The vacuum valve passing
water through the vacuum
pump stuck or damaged.
4.2
Check, repair or
replace the water
to pump valve.
4.3
The exhaust to pump valve
stuck or damaged.
4.3
Check, repair or
replace the fast
exhaust valve.
4.4
Door improperly closed,
gasket damaged or
incorrectly seated on the
groove.
4.4
Close the door, fix
or replace the
gasket.
4.5
Leakage at the vacuum or
exhaust piping.
4.5
Check and tighten
fitting joints,
replace defective
packing.
4.6
Steam inlet valve blocked or
damaged.
4.6
Fix or replace the
steam valve.
4.7
Low pressure at the steam
supply line.
4.7
Check the
generator as
shown in par. 2.
4.8
Control system trouble.
4.8
Replace the
control boards.
4.9
Manual steam feed valve is
closed.
4.9
Open the manual
valve.
5. Pre-vacuum phase
completed but
temperature and
pressure are low and
the sterilization point is
not reached or it takes
a long time to reach it.
5.1
5.2
Low pressure at the steam
supply line.
Steam inlet valve clogged or
damaged.
5.1
5.2
Check steam
generator, fix
pressure.
Check and fix or
replace the steam
valve.
5.3
Electronic pressure
transducers or measuring
circuits faulty or set too low.
5.3
Set correctly or
replace boards.
5.4
Control system trouble.
5.4
Replace the
control boards.
MAN205-0195042EN Rev. A Aug. 2011
Page 86 of 137 pages
Page 93
Symptoms
Possible causes check-ups and
tests
Corrections
6. Temperature rises
above the preset
sterilization value.
6.1
Steam pressure too high.
6.1
Check and set
correctly the
pressure switch of
the generator and
the pressure
reducer.
6.2
Steam valve leaks.
6.2
Fix or replace the
steam valve.
6.3
Control system trouble.
6.3
Replace control
boards.
7. Fast or slow exhaust
phases do not function;
chamber pressure
remains high or exhaust
takes too long.
7.1
The fast or slow exhaust
valves stuck or damaged.
7.1
Repair or replace
damaged valve.
7.2
Steam valve leaks.
7.2
Repair or replace
steam valve.
7.3
Control system trouble.
7.3
Replace control
boards.
8. Drying stage does
not work.
8.1
Trouble with the vacuum
system.
8.1
See par. 2 and 4.
8.2
Steam valve leaks.
8.2
Repair or replace
steam valve.
8.3
Control system trouble.
8.3
Replace control
boards.
9. The air inlet does not
work.
9.1
Air inlet valve clogged or
damaged.
9.1
Repair or replace
air valve.
9.2
Air filter clogged.
9.2
Replace air filter.
10. Unsatisfactory
results of sterilization
process.
10.1
Incomplete removal of air
pockets.
10.1
See trouble related
to vacuum system
par. 2 and 4.
10.2
Sterilization conditions
improper temperature or
pressure too low, ste. time
too short.
10.2
Set the correct
temp. and time
according to the
sort and quantity of
material.
10.3
Incorrect loading of
autoclave, air trapped in the
load.
10.3
See par. on
‗Preparation before
Sterilization‘.
11. Drying incomplete
packs remain wet.
11.1
Insufficient steam pressure
to jacket.
11.1
Set or fix the
pressure switch.
11.2
Insufficient vacuum.
11.2
See problems
related to vacuum
par. 2 and 4.
11.3
Steam trap does not
eliminate the condensate.
11.3
Clean or repair the
steam trap.
11.4
Incorrect loading of the
autoclave.
11.4
Reload the
autoclave
appropriately.
MAN205-0195042EN Rev. A Aug. 2011
Page 87 of 137 pages
Page 94
Symptoms
Possible causes check-ups and
tests
Corrections
12. The door does not
close.
(Applicableto sliding
doors)
12.1
Low pressure at the air
supply line.
12.1
Set the air
pressure; 1.5 bar
12.2
CLOSE DOOR solenoid
valve transmitting air
pressure to the door
actuator is stuck or
damaged.
12.2
Fix or replace
solenoid valve.
12.3
Door drive actuator
damaged.
12.3
Fix or replace
actuator.
12.4
OPEN DOOR button is
defective.
12.4
Replace the button.
12.5
Control system trouble.
12.5
Replace the control
boards.
13. The door does not
seal.
(Applicableto sliding
doors)
13.1
13.1
Set the air
pressure; 1.5 bar
13.2
Low steam pressure at the
door gasket.
13.2
Set the steam
pressure; 1.5 - bar.
13.3
The pressure to gasket
pneumatic valve blocked or
damaged.
13.3
Fix or replace the
pneumatic valve.
13.4
The solenoid or pneumatic
valves, which control the
pressure or vacuum to
gasket stuck or damaged.
13.4
Repair or replace
the defective valve.
13.5
Control system trouble.
13.5
Replace the control
boards.
14. The door does not
open.
(Applicableto sliding
doors)
14.1
Low pressure at the air
supply line.
14.1
Set the correct air
pressure (which
has to be
atmospheric
pressure).
14.2
Insufficient vacuum to
gasket, due to trouble with
the vacuum system.
14.2
See paragraph 2.
14.3
Gasket improperly seated or
damaged.
14.3
Mount the gasket
suitably or replace
it.
14.4
OPEN DOOR solenoid
valve transmitting air
pressure to the door
actuator is stuck or
damaged.
14.4
Repair or replace
the faulty valve.
14.5
Door drive actuator
damaged
14.5
Fix or replace
actuator.
MAN205-0195042EN Rev. A Aug. 2011
Page 88 of 137 pages
Page 95
Symptoms
Possible causes check-ups and
tests
Corrections
15. Problems related to
the control system.
15.1
Check if the flat cable or
MOLEX connectors
between the control boards
and keyboard are well
plugged in.
15.1
Plug in firmly the
MOLEX
connectors.
15.2
Power supplies out of order.
15.2
Fix or replace the
power supply.
15.3
Control boards or keyboard.
15.3
Replace defective
board of
microcomputer unit.
15.4
Paper to printer missing or
quality unsuitable.
15.4
Insert a paper roll
inside the printer.
Ensure the
appropriate type of
paper is used.
15.5
Flat cable connection
between control board and
printer is not plugged in
correctly.
15.5
Plug in connection
or replace it.
15.6
Printer damaged.
15.6
Replace the printer.
15.7
Temperature sensor
disconnected or loose
connection or sensor
damaged.
15.7
Fix connection or
replace sensor.
15.8
Pressure transducer, bad.
Mechanical or electrical
connections or transducer
damaged.
15.8
Fix connection or
replace transducer.
16. Air Detector Fails.
(If applicable)
16.1
Steam quality is not proper.
16.1
Check the steam
quality and noncondensable
gases.
16.2
Induced Air Valve is open or
leaks.
16.2
Close or repair the
induced air valve.
MAN205-0195042EN Rev. A Aug. 2011
Page 89 of 137 pages
Page 96
Symptom
Possible cause
Corrections
1. Steam
generator does
not start.
1.1 No power from the building
source.
1.2 Generator Circuit breakers
(1ph & 3ph) are OFF.
1.3 Trip coil is activated (no power
feed)
1.4 Water level in the generator is
low.
1.1 Check the reason for no
power supply from the
building.
1.2 Turn ON the circuit
breakers (1ph & 3ph)
1.3 Check the interlocks status.
1.4 No water inlet, See Section
No.2 below.
2. Water is not
filled into the
tank.
2.1 The water pump is defective or
blocked.
2.2 The water inlet solenoid valve
does not open.
2.3 The circuit breaker in the
water pump motor circuit trips
OFF.
2.4 The GICAR water level
controller or the electrodes is
defective.
2.5 The circuit Relay is defective.
2.6 The circuit breaker of the
control circuit is OFF or
defective.
2.1 Check, repair or replace
the pump.
2.2 Check power on solenoid
contacts or, repair/replace
the valve.
2.3 Check for short circuits, or
circuit breaker is defective.
Replace the circuit breaker,
or fix short circuit.
2.4 Check wires connectivity
between the electrodes
and the water level
controller or replace the
defective electrode or
electronic board.
2.5 Replace the circuit Relay.
2.6 Check and switch ON the
circuit breaker of the
control circuit.
9.4 Steam Generator Troubleshooting
MAN205-0195042EN Rev. A Aug. 2011
Page 90 of 137 pages
Page 97
Symptom
Possible cause
Corrections
3. Steam pressure
does not
increase or
increases too
slowly.
3.1 The pressure switch is faulty
or incorrectly set.
3.2 The circuit breakers in the
heater circuits are switched
OFF.
3.3 The water level control system
is defective.
3.4 The heater contactor is
defective.
3.5 Heaters are burned out.
3.6 There is a leakage in the
safety relief valve caused by
loose or defective fittings, or
by blockage.
3.1 Check the pressure
switch, set it correctly or
replace if faulty.
3.2 Check the cause and
switch ON the circuit
breakers.
3.3 Check and replace the
defective electrode or
GICAR controller.
3.4 Check and replace the
heater contactor.
3.5 Replace the damaged
heaters; check if the
water level is sufficient.
3.6 Tighten or replace piping
connections, fix or
replace the safety valve.
4. Steam pressure
goes up beyond
the set control
point.
4.1 The pressure switch is faulty
or set incorrectly.
4.2 The heater contactor is stuck.
4.1 Set the pressure switch
correctly or replace if
faulty.
4.2 Replace the heater
contactor.
5. The safety valve
blows.
5.1 The steam pressure is higher
than the working pressure.
5.2 The safety valve is defective.
5.1 Check cause and
remedy it, See section 4
above)
5.2 Check and replace the
safety valve.
MAN205-0195042EN Rev. A Aug. 2011
Page 91 of 137 pages
Page 98
Symptom
Possible cause
Corrections
1. Pump does not
start.
1.1 Fuse burnt or circuit
breaker tripped.
1.2 Wrong voltage.
1.3 Damaged electrical
connection.
1.4 Faulty pressure switch.
1.5 Open or grounded circuit
due to faulty rectifier or
motor.
1.6 Locked drive assembly.
1.1 Replace fuse or turn
on the circuit
breaker.
1.2 Use right voltage.
1.3 Fix connections.
1.4 Replace pump.
1.5 Replace pump.
1.6 Replace pump.
2. Pump does not
prime (motor
runs but water
is not
discharged.
2.1 No water supply.
2.2 Inlet water strainer
clogged.
2.3 Vacuum leak in inlet line.
2.4 Inlet or outlet tube
severely kinked.
2.5 Debris in pump inlet or
outlet valves.
2.6 Pump operating on wrong
voltage.
2.7 Pump housing damaged
(cracks).
2.1 Fix water supply.
2.2 Clean inlet strainer.
2.3 Replace piping.
2.4 Straighten or
replace tube.
2.5 Clean valves.
2.6 Use right voltage.
2.7 Replace pump.
3. Leak from
pump head or
switch.
3.1 Loose screws at switch or
pump head.
3.2 Switch diaphragm
ruptured or pinched
3.1 Fasten screws
3.2 Replace damaged
pump.
4. Pump will not
shut-off
4.1 Output line closed and no
leaks.
4.2 Air trapped in outlet line
or pump head.
4.3 Pump operating on wrong
voltage.
4.4 Inlet or outlet valves
clogged.
4.5 Loose drive assembly or
pump head screw.
4.6 pressure switch
operation/adjustment
incorrect
4.1 Open outlet line.
4.2 Remove trapped air.
4.3 Use right voltage.
4.4 Clean clogged
valves.
4.5 Fasten loose
screws.
4.6 Refer to S/B #1031
for differential and
pressure adjustment
procedure.
5. Pump runs
loudly
5.1 Loose pump head or drive
screws.
5.1 Tighten loose
screws.
9.5 Troubleshooting for Water Pump SHURFLO
MAN205-0195042EN Rev. A Aug. 2011
Page 92 of 137 pages
Page 99
9.6 The SHURFLO Water Pump Rear Endbell Replacement Kit
Warning
Topreventelectricalshock,disconnectpowerbeforeinitiatinganywork. In the
case of pump failure, the motor housing and/or the pumped fluid may carry high
voltage to components normally considered safe.
Caution
Release pressure on the outlet side of the pump before doing any maintenance
work.
Inspect the motor armature/commutator for any indication of the following conditions.
Check the commutator brush contact surface for deep wear, scores, filled/shorted slots,
or a burnt condition. Minimum commutator diameter is .850 in. [21.5 mm] (115 &
23OVAC). Check armature windingsforopen,shorts,internalground,andcommutator
connections. The windings should not be overheated, black in color, or have a burnt
odor.
If the motor has any indication of the aforementioned or other failure modes, the endbell
kit will not correct the failed condition. Complete motor assemblies. Contact Tuttnauer
for a complete motor assembly.
Replacement Instructions:
1. Mark the motor housing to index the location of endbell wires to the housing.
NOTE:
If the endbell is improperly indexed to the motor housing (180°) the motor will rotate in
the opposite direction.
2. Remove the two motor assembly screws using a 5/16‖ socket wrench or nut
driver.
3. Remove the rear endbell assembly. Inspect for signs of excessive wear on the
commutator and/or armature. Ensure the proper placement of washers on the
shaft as shown.
MAN205-0195042EN Rev. A Aug. 2011
Page 93 of 137 pages
Page 100
CONDITION A
CONDITION B
Appliance
Rating
Potential
Volts
Time
Seconds
Potential
Volts
Time
Seconds
Less than 100
600
1
100 – 130 volts
1000
60
1200
1
210 – 240 volts
1480
60
1780
1
4. Slide the new endbell assembly onto the shaft as far as the brush retention clip
will permit.
5. Index the endbell wires to mark made in step #1. Align endbell to the slots in
the motor housing. Pull the brush retaining clip out while pressing the endbell
flushes to the motor housing.
6. Connect the black 115V (brown 230V) wire to the pump switch if applicable.
7. Install the motor assembly screws along with the green/yellow wire (115V
only). Torque to 12º18 m. lbs.
Perform Hi-Pot Test as follows:
1. The system conductors must be shorted
together, and all switches must be turned
―ON‖.
2. Hi-pot voltage is applied between the
shorted conductors and accessible dead
metal. The voltage frequency should be
within the range of 40-70 hertz.
3. Voltage should be applied in accordance
with either condition ―A‖ or condition ―B‖
per the table below.
MAN205-0195042EN Rev. A Aug. 2011
Page 94 of 137 pages
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