INSTALLATION AND OPERATING MANUAL

SD 660

HIGH TEMPERATURE STEAM STERILIZER

with

EXTERNAL STEAM SUPPLY

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TABLE OF CONTENTS PAGE

1. Introduction ......................................................................................... 3
2. Warranty .............................................................................................. 3
3. Safety measures ................................................................................ 4
4. Switching on for the first time ........................................................... 4
5. Operation ............................................................................................. 6
5.1 Pressure gauges ................................................................................... 6
5.2 The operator panel ............................................................................... 7
5.3 Programmed cycles .............................................................................. 9
5.4 Selecting a cycle ................................................................................... 9
6. Commissioning test cycles ............................................................. 10
6.1 Vacuum leak test ................................................................................ 10
6.2 Bowie & Dick test ................................................................................ 10
6.3 Testing the operating cycles ............................................................... 11
7. Operational cycles ............................................................................ 12
7.1 High temperature packs cycle ............................................................ 12
7.2 Low temperature packs cycle - rubber goods cycle ........................... 13
8. Loading the sterilizer ....................................................................... 14
9. Starting a cycle ................................................................................ 14
10. Cycle operation ................................................................................ 14
11. The printout ...................................................................................... 15
12. The display ....................................................................................... 15
13. Aborted and failed cycles ................................................................ 16
13.1 Fault messages................................................................................... 16
14. Panel printer ...................................................................................... 17
14.1 Changing the paper roll ...................................................................... 17
14.2 Replacing the printer ribbon ................................................................ 17
15. Setting the date and time ................................................................. 18

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1. Introduction
The SD 660 sterilizer is a horizontal autoclave with fully automatic door operation,
having a chamber cross - section of 660mm x 660mm. The autoclave has a double-
walled structure, the inner chamber where the sterilization process takes place and
the outer shell (jacket). An external source supplies the steam for the sterilizing
process and for heating of the autoclave jacket.

The control unit of the sterilizer is fully automatic, hence after selecting the program
and starting the cycle, no further intervention of the operator is necessary. The
selected program, the main phases of the cycle and the status of the machine are
indicated by messages displayed on the front panel. A pressure / vacuum gauge
indicates the pressure level in the chamber and a pressure gauge also indicates the
pressure within the jacket.

For process documentation, the cycle information concerning operation is printed in

hard copy by a panel printer. The pushbuttons located on the front panel, enable the
operator to select the program, and to start the selected cycle.

This manual is intended to give the user a general understanding of how the unit
works and indicates the most effective way to care for and maintain the unit to ensure
optimum results and years of trouble-free operation. Despite the simplicity of
operation for the user, sophisticated technology is incorporated into the control unit.
Any unauthorised repair may result in damage to the sensitive components.

2. Warranty Statement
Your SD 660 sterilizer is of high quality manufacture. If you have any difficulty
concerning operation, and the solution is not covered in the maintenance manual,
please contact the dealer where the unit was purchased, or our customer and
technical service department at the following e-mail address:

sales@steridium.com

Only qualified technical personnel should carry out service procedures. Describe the
problem as clearly as possible so we can diagnose the problem and provide a
prompt solution. If the autoclave is equipped with a printer, forward a copy of the last
printout for our inspection. If replacement parts are needed stipulate the model and
serial number.

We hereby certify that this autoclave is guaranteed to be free from defects in material
and workmanship for one (1) year against faulty components and assembly. Our
obligation is limited to repairing or replacing parts, after our examination, if within one
(1) year after the date of shipment they prove to be defective.

This warranty does not apply to improper installation or application; nor shall it extend
to products which have been altered outside the factory without prior authorization
from us; nor products which have been improperly maintained.

No products will be accepted for repair without proper authorization from us. All
transportation charges must be paid both ways by the owner.

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3. Safety measures

The design of the sterilizer and auxiliary components, as well as the operation
mode are based on safety rules, aimed at protecting the personnel operating or
servicing the unit.

1. Only qualified personnel should work with the autoclave after receiving
suitable training. The operator will proceed according to the operating
instructions and will not make any change in the working procedures or the
process data, without the express instructions of the person in charge.

2. The personnel operating the sterilizer will use protective garments and
materials according to working procedures of the establishment.

3. The maintenance and service works will be executed only by authorized

technicians, provided with the documentation and the instruments suitable
for the kind of work to be done.

After executing the maintenance and /or repair works, the autoclave will be
thoroughly checked and tested in operation, to make sure it is in perfect operating
condition.

4. Switching on for the first time

When the unit has been connected to all the required services - water, steam, drain,
power - it is necessary to check the rotation of the electric motors to ensure that the
motors turn in the right direction.

Main circuit breaker

Control circuit breaker

Vacuum pump contactor

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1. Ensure that any straps holding the door or counterweights have been
removed, that the door is free to move, and that the chamber is empty.
Ensure that the main steam supply valve is closed.

2. Ensure that the single phase control circuit breaker is OFF.

3. Switch ON the three-phase main circuit breaker and the main power supply.

4. Push the lever of the vacuum pump contactor for a short time (1 - 2
seconds). Check the rotation of the vacuum pump. It should be rotating
clockwise when viewed from the fan end and anti-clockwise when viewed
from the pump end. If the rotation is incorrect, switch off the power and
change over any two of the main incoming phases. DO NOT CHANGE THE
PHASES OF THE PUMP MOTOR - CHANGE THE TWO PHASES OF THE
INCOMING POWER SUPPLY.

Vacuum pump rotation to be

anti - clockwise when viewed
from the pump end.

5. If the door is open, push the lever of the door close contactor for a short time
(1 - 2 seconds). Check that the door closes (moves upwards).

6. If the door is closed, push the lever of the door open contactor for a short time
(1 - 2 seconds). Check that the door opens (moves downwards).

7. Use the OPEN and CLOSE door contactors to get the door to about the
midway position. The door motor can also be manually turned to do this by
turning the motor shaft on the rear of the motor.

8. Turn the red power ON/OFF - Emergency STOP button on the front control
panel to the ON position. The controller will power up, the display will come
on, and the system will take a few seconds to initialize.

9. Press the door OPEN button and check that the door starts to move
downwards. If it does, the door will continue opening until it reaches the
bottom limit switch and will then stop when fully open. If the door starts to
move upwards after the door OPEN button is pressed, immediately press the
red emergency STOP button.

10. Press the door CLOSE button and check that the door closes until the top
limit switch is reached and the door is fully closed.

11. The rotation of all motors is now correct.

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Ensure that the steam generator is fully up to pressure, and open the steam isolating
valve on the autoclave. The jacket will start to heat up to the operating temperature
which is dependent on the selected cycle.

Check that there are no steam or water leaks.

5. OPERATION

5.1 Pressure gauges

The pressure gauges for the boiler, jacket, and chamber are located on the front
panel above the door.

Boiler pressure gauge Jacket pressure gauge Chamber pressure gauge

MAINS (BOILER) PRESSURE GAUGE

This indicates the boiler gauge pressure in bar. The normal operating pressure is
between 3.5 bar and 4.0 bar.

JACKET PRESSURE GAUGE

This indicates the jacket gauge pressure in bar. The normal operating pressures are
between 1.0 bar and 2.65 bar depending on the sterilizing cycle.

CHAMBER PRESSURE GAUGE

This indicates the chamber gauge pressure in bar. The normal operating pressures
are between –1.0 bar (full vacuum) and 2.65 bar.

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5.2 The operator panel

The operator panel is extremely simple and consists of the following:

ON/OFF switch
Emergency STOP

Display

Control pushbuttons

Editing pushbuttons

Printer

Printer paper feed button

DISPLAY
This is a two-line display that gives messages to the operator as well as various
readouts during a cycle.

When the sterilizer is in idle mode (not in a cycle), the display will show the selected
cycle as well as any error messages. If there are no error messages the display will
indicate the status of the door – open or closed.

During a cycle the display will show the stage of the cycle as well as the chamber
temperature and pressure. If the SELECT button is pressed once the display will
show the jacket and boiler (or water tank) temperatures. If the SELECT button is
pressed again the display will show the elapsed time of the current stage, target time,
and target temperature or pressure.

PRINTER
The printer is used for providing records of operational cycles as well as printing error
messages, cycle parameters and variables, calibration data etc.

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PRINTER FEED button
This is used to feed paper through the printer when loading paper.

ON/OFF button
This is used to switch the sterilizer on and off and also acts as an emergency stop
button. Once the sterilizer has been commissioned it should be left on to await the
first load as it takes about 30 minutes to reach the lowest operating temperature after
switching on from cold. If the sterilizer is not expected to be used for a few days it
can be switched off.

CONTROL PUSHBUTTONS

SELECT button
This is used to scroll through the available cycles in order to select the
required cycle appropriate to the load. It is also used to read other parameters
during a cycle – see DISPLAY above.

START button
This is used to start a cycle.

OPEN button
This is used to open the door on models with automatic powered doors.

CLOSE button
This is used to close the door on models with automatic powered doors.

EDITING PUSHBUTTONS

These pushbuttons are not used in the normal operation of the sterilizer. They are
used by engineering staff for editing the machine setup variables, cycle parameters,
printing reports, setting the date and time, analogue calibration, and editing
passwords.

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5.3 Programmed cycles

The control system has the capacity for storing up to 20 cycles. Two test cycles are
installed on every autoclave. Various operational cycles can be installed depending
on each user’s requirements and specifications. Typical installed cycles are shown
below.

OPERATIONAL CYCLES
PACKS HIGH TEMP For porous loads such as textiles and other wrapped
items that can withstand 134 - 138 C.
PACKS LOW TEMP For porous loads such as rubber goods and other
wrapped items that can withstand 121 - 124 C.

TEST CYCLES
LEAK TEST An automatic test to ensure that there is no
unacceptable leakage into the chamber.
BOWIE DICK TEST Used for testing standard Bowie & Dick test packs at
134 C for 3.5 minutes.

5.4 Selecting a cycle

The display will show the current selected cycle on the top line of the display. Press
the SELECT button to change the cycle until the desired cycle is displayed.

Every cycle consists of various stages as shown in the diagram below. Each stage
(except for common stages of gasket inflate and gasket release) has a target value of
time, temperature or pressure. If the target value cannot be reached within a preset
time, the cycle will abort to the stage designated for each stage. For example, if the
unit cannot draw a vacuum of 30 kPa within a set time (stage 4), the cycle will abort
to stage 8 (air admission) and the cycle will continue from that stage (8).

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6. Commissioning test cycles

6.1 Vacuum Leak Test

The sterilizer must first be put through a leak test cycle to determine if there is an
excessive leak into the chamber when under vacuum conditions. A vacuum is drawn
in the chamber and the vacuum pump then switched off and the exhaust valve
closed. The chamber temperature is allowed to stabilise after which the chamber
pressure is monitored to check that the leak rate does not exceed acceptable
standards. The chamber is then returned to atmospheric pressure, the gasket seal
deflated and the door unlocked.

If the rate of pressure rise during the leak test stage exceeds a set value (normally
1.3 kPa), both the display and printer will show LEAK TEST FAILED. If the pressure
rise is within acceptable limits the message will show LEAK TEST PASSED and the
printout will show LEAK TEST COMPLETE. The sterilizer should not be operated
unless the leak test passes.

NOTE: If the leak test cycle is started immediately after the sterilizer has warmed up
from cold or from a lower temperature cycle, it can occur that the leak test might fail
due to incomplete heating of the chamber. Run a second leak test cycle immediately
after the failed cycle. If this also fails, maintenance procedures will have to be carried
out to remedy the leak.

6.2 Bowie Dick Test

Once the sterilizer has passed the LEAK TEST, run a Bowie Dick test cycle using a
standard Bowie Dick test pack, the chamber otherwise being empty. The Bowie Dick
Test is used to ensure that the sterilizing cycle for porous loads (packs) functions
correctly.

The Bowie Dick Test cycle is the same as the Packs High Temperature cycle except
that the sterilizing time is reduced to 3.5 minutes and the drying time is reduced to 2
minutes.

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The various stages of a typical Bowie & Dick Test cycle are shown below.

A typical Bowie & Dick test card which has been through a successful cycle is shown
below.

6.3 Testing the operational cycles

Once the sterilizer has passed the vacuum leak test and Bowie Dick test, each of the
other operational cycles can be run with an empty chamber to ensure that all cycles
are operating correctly. Run cycles which sterilize at 134 C first, then those that
sterilize at 121C (packs low temp / rubber goods). Keep all detailed printouts for
record purposes.

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7. OPERATIONAL CYCLES

Every sterilizer is supplied according to the client’s specifications and requirements,

and will therefore be programmed with its own operational sterilizing cycles. The
following cycles are typical “standard” cycles installed on the SD 660 series.

7.1 High Temperature Packs Cycle

The high temperature packs (porous loads) cycle is used for sterilizing wrapped
items at 134 C. It should not be used for items that cannot withstand high
temperatures (up to 138 C), high pressures (up to 265kPa gauge pressure) or deep
vacuum.

The stages of a typical high temperature PACKS cycle are shown below.

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7.2 Low Temperature Packs Cycle - Rubber Goods Cycle

The low temperature packs (porous loads) or RUBBER GOODS cycle is used for
sterilizing wrapped items at 121 C. It should not be used for items that cannot
withstand high temperatures (up to 124 C), high pressures (up to 130kPa gauge
pressure) or deep vacuum.

The stages of a typical low temperature RUBBER GOODS cycle are shown below.

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8. Loading the sterilizer

The items to be sterilized should be placed in baskets on the two levels of the
loading carriage (if supplied) or on the internal shelves (if fitted).

Do not overload the chamber by packing it too full of items.

Do not allow any items to cover the chamber drain.

9. Starting a cycle

The bottom line of the display will flash any error messages that might prevent the
cycle from being executed properly. Typical errors include the following:

Jacket temperature high or low

Boiler (water tank) temperature high or low
Low vacuum pump water level

If the START button is pressed while a fault condition exists, the printer will print out
a list of the current faults, and the cycle will not start. Wait until all fault conditions
have been rectified before trying to start another cycle.

The low water conditions should not normally occur (except when the machine is
being switched on for the first time or after the tank has been emptied for a service)
and if these messages appear check that all water and air supply valves are open,
and that the facility has normal water and air pressure.

The low or high temperature alarm conditions can exist for a long time while the
sterilizer cools down from a higher operating temperature, or is heating up from a
lower operating temperature.

If no alarm conditions exist, the sterilizing cycle can be started after the chamber has
been loaded and the door fully closed.

10. Cycle operation

As soon as the START button is pressed, the cycle will automatically progress
through its programmed stages. The display will show various messages and the
printer will record essential data such as cycle stage, time, chamber temperature
and pressure, alarms, etc.

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11. The printout

At the start of the cycle the printer will print out the following:

ID NUMBER XXXX CYCLE NUMBER XXXX

DATE XX/XX/XXXX TIME XX/XX/XX
CYCLE NAME

TIME STAGE NAME TEMP PRESS

HH:MM:SS (C) (kPa)

The time, stage name, chamber temperature and pressure will be printed throughout
the cycle.

The printout will also show any alarms or failures that occurred during the cycle, and
will print the cycle name and either COMPLETE at the end of a successful cycle, or
UNSTERILE at the end of an unsuccessful cycle.

12. The display

During a cycle the display will show the stage of the cycle on the top line and the
chamber temperature and pressure on the bottom line, for example:

STERILIZE
135.5 C 320 kPa

If the SELECT button is pressed once, the display will show the jacket and boiler (or
water tank) temperatures on the bottom line, for example:

STERILIZE
J 136.2 C B 149.1 C

If the SELECT button is pressed again the display will show the elapsed time as well
as the target values for that stage, for example:

STERILIZE
3.30 6.00 134.0

3.30 is the elapsed time in minutes and seconds for the sterilize stage
6.00 is the target time for the sterilize stage
134.0 is the target temperature for the sterilize stage.

At the end of the cycle the display will also indicate whether the cycle was successful
(COMPLETE) or failed (UNSTERILE).

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13. Aborted and failed cycles

The programmed cycles are made up of combinations of various stages. During each
stage certain fault conditions are monitored which can affect the sterility of the load or
the correct functioning of the sterilizer.

13.1 Fault messages

When a fault condition is detected the time is printed followed by a short description
of the fault. Some messages may also contain a temperature or pressure value.

The following fault conditions will print a message each time that they occur during
the cycle, but will not cause an abort or unsterile condition:

“VACUUM PUMP WATER LOW”

“VACUUM PUMP TRIP”
“CIRCULATION PUMP TRIP”
“JACKET TEMPERATURE HIGH” (Jacket temperature is printed)
“JACKET TEMPERATURE LOW” (Jacket temperature is printed)

NOTE:
1. The “jacket temp low” alarm can occur in the course of a cycle due to filling of
the supply boiler with raw water, or a temporary pressure drop caused by the cold
load. It is vitally important not to overload the sterilizer otherwise these alarms will
occur regularly and the cycle will become excessively long.

2. Earlier models controlled the temperature of an integral boiler. Latest models

control the integral boiler via a pressure switch and the boiler temperature channel is
used to control the water temperature in the water tank. In this instance the boiler
temperature alarms will refer to the water tank temperature and not the boiler
temperature.

If the sterilizer does not achieve the target conditions for any stage, the cycle will
abort. This also applies to power failures during a cycle.

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14. Panel printer

14.1 Changing the paper roll

When the paper is nearing the end of the roll, a red dye
will be seen on the edge, and the paper should be
changed. The front cover can be slid downwards and
removed to expose the printer ribbon and mechanism.

Press the PAPER FEED button on the front panel

next to the printer to expel remaining paper from the
printer. Follow instructions on the printer for removal
of the roll, left-hand side first.

Feed the paper on the replacement roll through the printer head and the ribbon
cassette and then locate the roll in position. Press the PRINT FEED button until 2 cm
of paper is exposed and pass that through the slot in the outer cover, and slide the
cover back into position.

14.2 Replacing the printer ribbon

To replace the ribbon cartridge proceed as follows:

Remove the black printer cover.

Press the end of the cartridge marked PUSH/

EJECT. The cartridge will swing out to the left;
remove it from the printer. Rotate the new
cartridge dial as shown by the arrow to tighten up
the ribbon. With the ribbon facing up, feed the
paper between the cartridge and the ribbon.
Replace the cartridge into the printer. Press the
PAPER FEED button on the front panel until 2
cm of paper is exposed and feed that through the
outer cover. Replace the outer cover.

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15. Setting the date and time.

The date and time can be set by using the Steridium software, or if the software is
not available from the front panel .

The buttons referred to in the diagrams are the buttons on the controller. The buttons
in the diagram correspond to the buttons on the front control panel and controller as
follows:

FLOWCHART FRONT PANEL CONTROLLER

SET ENTER SET
ESC EXIT MODE
UP UP
DOWN DOWN

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To change the date, press and hold down ENTER on the front panel (or SET on the
controller) for 5 seconds to enter the MAIN menu.

Use the UP / DOWN buttons to display the SET DATE menu.

Follow the flowchart below to set all the parameters for the DATE.

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To set the time, follow the same procedure to display the SET TIME menu.

Follow the flowchart below to set all the parameters for the TIME.

For any further information or assistance, please contact your local

Steridium agent or contact Steridium directly at:

www.steridium.com sales@steridium.com

PO Box 5296, Q Super Centre, Queensland, 4218, Australia

Tel: +61 7 55 931 352 Fax: +61 7 55 931 876

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APPENDIX A: Installed cycles

This unit has been pre-programmed with the following cycles. The images below
show the installed cycle details (on the left) and the factory run cycles (on the right).
These records can be used as a basis for comparing the operation of the autoclave
at any time to the original factory run cycles.

1. Operational Cycles

1.1 Packs @ 134 C

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2. Test Cycles

2.1 Vacuum Leak Test

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2.2 Bowie & Dick Test

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