STEAM STERILIZER
Instruction manual
STE18L/23L-D Class B
Aison international AB
Stigs Center 2B,
42246,Hisings Backa
Sweden
Mob:+46-(0)73-5543108
Web: www.autoclave.se
Email: [email protected]
Instruction manual
FOREWORD
Thank you for purchasing this STEAM STERILIZER. It is manufactured to the highest
standards using quality materials. Please follow all recommended maintenance,
operational and safety instructions and you will receive years of troublefree service.
This manual is an unseparated part of the device, Save this manual for future reference and
keep in the vicinity of the product.
I
Instruction manual
CONTENTS
FOREWORD.......................................................................................................................Ⅰ
CONTENTS........................................................................................................................Ⅱ
1.GENERAL........................................................................................................................1
2.TECHNICAL PARAMETER.............................................................................................3
3.PACKING CONTENT.......................................................................................................4
4.INSTALLATION...............................................................................................................5
5.OPERATION....................................................................................................................6
5.1 FILLING THE DISTILLED WATER.........................................................................................6
5.2 PREPARING THE MATERIAL TO BE STERILIZATION........................................................7
5.3 SELECTING THE STERILIZATION PROGRAM....................................................................8
5.4 RUNNING THE STERILIZATION PROGRAM........................................................................9
5.5 TEST PROGRAM....................................................................................................................11
6.ADVANCED SETTING....................................................................................................13
7.MAINTENANCE..............................................................................................................17
8.TRANSPORT AND STORAGE.......................................................................................20
9.ALARM............................................................................................................................21
10.SAFETY DEVICES........................................................................................................22
APPENDIX
1. CHARACTERISTICS OF THE FEEDING WATER...............................24
2. DIAGRAMS OF THE STERILIZATION PROGRAMMES.....................25
3. ELECTRICAL DRAWING.....................................................................30
4. HYDRAULIC DRAWING......................................................................31
Instruction manual II
1.GENERAL
This sterilizer described in this manual is intended for the sterilization of re-usable
surgical instruments and material.
It operates automatically with 134℃ and 121℃ sterilization temperatures. The
sterilizer is a Medical device class Ⅱa, in accordance with article 15-Appendix Ⅸ of
the European Directive 93/42/CEE and it has been produced in accordance with the
EN13060.
1 Distilled water tank 9 Door handle
2 LCD screen 10 Door
3 Control panel 11 Safety valve
4 Printer 12 Air filter
5 Main switch 13 Condenser ventilation
6 USB port 14 Break switch
7 Drain connector of distilled water tank 15 Power supply cord
8 Drain connector of used water tank
Instruction manual -1-
Security Notice:
In order to proper use of the sterilizer, please be sure to read the warning and
attention carefully for safety.
Grounding protection
This symbol is grounding protection inside the machine.
Hot surface
This symbol is visible at the rear of the unit and on the front of the panel after opening
the door.
Important safety information
This symbol is used to draw the attention of the reader to particularly important notions
for operator safety.
Instruction manual -2-
2.Technical Parameters
Item STE18L STE23L
Chamber volume 247mm x350mm 247mm x450mm
Rated Voltage AC220V(AC110V),50-60Hz
Main Fuses T12A/250V(T20A/250V for 110V)
Nominal Power 1800VA 2000VA
Sterilization Temperature 121℃/134℃
Capacity of the distilled Approx 2.5L(water at level MAX)
water tank
Approx 0.5L(water at level MIN)
480mm(width) 480mm(width)
Outside Dimensions x465mm(height) x465mm(height)
x590mm(length) X690mm(length)
Net Weight 47Kg 51Kg
Noise <70db
Relative Humidity Max 80%, non condensing
Atmosphere pressure 76kPa-106kPa
Instruction manual -3-
3.Packing Content
NO. Item Quality
1 18L/23L Steam sterilizer 1
2 Instrument tray 3
3 Instrument tray rack 1
4 Instrument tray handle 1
5 Door adjustment tool 1
6 Draining hose 2
7 Instructions manual 1
8 Door seal 1
Main fuse
9 2
(T12A/250V for 220V/T20A/250V for 110V)
Instruction manual -4-
4. Installation
* There must leaves 10cm gap around sterilizer, and 20cm on top side. the
clearance required for the movement of the door： leave an at least 450mm
fan-shaped space in front of the door.
* The place which sterilizer located must be ventilated, make sure that the radiator
not being jammed.
* The sterilizer should be placed on a level worktable.
* Don't cover or block the door, ventilation or radiation openings on the sterilizer.
* Don't place the sterilizer near a sink or in a location where it is likely to be
splashed.
* Keep away from all sources of heat.
Instruction manual -5-
5.Operation
5.1 Filling the distilled water
5.1.1 Open the door and take out all the instrument trays and other accessories
inside, unpack and clean them.
5.1.2 Connect the power
5.1.3 Switch on
Switch on the sterilizer through the mains switch
mounted on the right side. At the switching on, the
machine turns on the LCD display and self-test starts.
It will show the door position, water level,
working program, date, time , etc. .
The machine will alert by beep sounds if there are
problems. After the test the following information will
be shown:
Distilled water tank is lacking of water.
Used water tank is full.
Printer is disconnected if it is blinking
Instruction manual -6-
Door opened.
Door locked.
Notice: Before using the sterilizer at the first start-up or any time the signal
blink, it is necessary to fill the distilled water tank with distilled water.
5.1.4 Fill the distilled water
Open the top lid, and pour into the tank with appropriate distilled water by cup
or tank. When you hear a beep signal, it means the water level is exceed the max.
level. Please stop filling immediately.
5.2 Prepare the material to be sterilized
To get the best effectiveness of the sterilization process and to preserve
the material in time, follow the indications below reported.
* Arrange the tools of different metal (stainless steel, moderate steel,
aluminum, etc.) on different trays or however well separate between them;
* In case of not stainless steel tools, interpose a sterilization paper napkin or
muslin cloth between tray and tool, avoiding direct contacts between the
two different materials;
* Verify all the tools are sterilized in open position;
* Arrange the containers (glasses, cups, test-tubes, etc.) on one side or
inverted position, avoiding possible water stagnation;
* Don't overload the trays over the stated limit (see Appendix 1).
* Don't stack the trays one above the other or put them in direct contact with
the walls of the sterilization chamber.
Instruction manual -7-
* Always use the instrument tray handle.
* Wrap the tools one by one or, if more tools have to be set in the same wrap,
verify that they are of the same metal;
* Seal the wrap with sterilization adhesive ribbon or by a thermal sealer.
* Don't use metallic clips, pins or other, as this jeopardizes the maintenance of
the sterility;
* Turn the sterilization paper in order to set the plastic part downward (tray side)
and the paper part upward.
Always wrap the tools in case of prolonged store.
5.3 Selecting the sterilization program
5.3.1 LCD display
Displays the cycle temperature, pressure, error code,
sterilization state and program.
5.3.2 MENU button
Select item and save adjustment.
5.3.3 UP button
Select up button to select program or adjust and setup the parameter. Or open
the door.
5.3.4 DOWN button
Select down button to select program or adjust and setup the parameter.
5.3.5 START button
Instruction manual -8-
Press this button to start the sterilization cycle, holding this button above 3
seconds to stop the cycle.
5.3.6 Select the program
Press button, enter the menu, then select the "Programs", you will see the
available sterilization programs:
Select the program by button and confirm it by press button. If you
don't want to select a program you may press to exit.
5.4 Running the sterilization program
After selecting program, put the
instruments into the chamber by tray handle.
5.4.1 After the instruments are loaded, you
may close and lock the door .
5.4.2 Start the sterilization program.
Press START button，the machine will starts a cycle automatically. It will take
30-75 minutes. (See Appendix 2)
Caution：
When you press the "Start" button the door handle has not been turned to the
maximum position, you will see the blinks on the screen, It means you can not
start a cycle until you close the door completely and press the "Start" button again.
Instruction manual -9-
5.4.3 Sterilization cycle end
After a cycle completes, the printer will start work and print the report of the
sterilization cycle data.
After the pressure is 0 ,you may open the door, and take out the sterilized
Instruments.
Always use the tray handle to load and unload the tray in order to avoid
scald.
5.4.4 The drain connector
Whenever blinks, it means the used water tank if full, you need to drain it
immediately in the way as following described.
1.Push the hose to the waterspout of the 2.Turn the waterspout anticlockwise.
connector.
Instruction manual - 10 -
3.Pull the waterspout out .Then the tank will be 4.After finish draining water,push waterspout and
drained. turn clockwise to the position as fig.
5.5 Test program
5.5.1 Press button,enter the menu. And then select the "Test Select",you
will see the test menu.
5.5.2 Select the "B&D TEST".
5.5.2.1 Put the Bowie-Dick pack into the chamber. Then close the door and
press .
5.5.2.2 After finish the cycle you check the indicator. And evaluate the result.
5.5.2.3 Open the door it will return to the initial interface.
5.5.3 Select the "HELIX TEST"
5.5.3.1 Put the indicator paper in the capsule.
5.5.3.2 Put the Helix tube into the chamber. Then close the door .
5.5.3.3 After finish the cycle you check the indicator. And evaluate the result.
Instruction manual - 11 -
5.5.3.4 Open the door it will return to the initial interface.
5.5.4 Select the "VACUUM TEST"
5.5.4.1 Then close the door and start program.
5.5.4.2 After finish the cycle it will show the result.
5.5.4.3 In compliance with EN 13060, the test requires the air leakage rate less
than or equal 0.13kPa/min during the 10 minutes.If the leak on the screen is not
greater 0.13,it will show OK. Or it will show failure.
5.5.4.5 "Tp" is the temperature difference between the max. temperature and the
min. temperature during the cycle. If it is greater 3℃ it will show void. That means
the result is void. You need run the test again after the chamber has cooled down.
5.5.4.6 Open the door it will return to the initial interface.
Caution: The test must be carried out with unit cold. if the Tp is greater 3℃, it will show void.
Instruction manual - 12 -
6. Advanced Setting
6.1 Basic set
Press button. And then select the "Basic set",you will see the available
adjustable items:
6.1.1 Select the item by press the button.
6.1.2 Adjust the parameter by press the button.
6.1.3 If you want to finish the adjustment and save what you changed, you may press
button until it return to the above menu.
6.1.4 The "Counter" is the count of cycle. It can not be changed.
6.5.5 The button is for cancel and exit.
6.2 Select the "Info. output" to print the cycle information
Instruction manual - 13 -
It can store 20 records in the memory. The latest record will overwrite the oldest one.
6.2.1 Press button to select "Info. Output" and press button to enter the
display.
6.2.2 Choose one record(the cycle no.) . Press button, the printer will print the
information and output the information to USB port.
6.3 Parameter adjust
Press button, then switch on. Holding down the button until the LCD displays
the menu.
6.3.1 Press button to select a program you want to
adjust.Press the button to enter the menu.
6.3.2 Select the item by press button .
6.3.3 Adjust the parameter by press the button.
6.3.4 Holding time:1-60min.Drying time:N-1-20min.
It is not the total drying time, there is base time
before the setting time.The data N means there
is no vacuum drying.Press button to cancel
and exit.
6.3.5 After you finish adjusting the parameter you
may press button to save the parameter and
Instruction manual - 14 -
return the above menu.
6.4 Altitude set
If the device can't enter the holding time or use this machine at a high altitude
place , you need to adjust altitude parameter.
6.4.1 Select "Altitude set",adjust the parameter by press button. Press
button to save. Press button to cancel and exit.
6.4.2 The value is 0~2.
Altitude 1.5>h>0.5 km, value 1.0;
Altitude 2.5>h>1.5 km, value 2.0;
Note: The standard atmospheric pressure is about 100kPa. And the pressure
decrease 5kPa for each 0.5 kilometers of altitude increased.
Notice: We don't suggest the operator to adjust the parameter if it is not
necessary.
6.5 Unit set
6.5.1 select "Unit" and press button to enter the setting screen.
6.5.2 Select the pressure or temperature by press button.
6.5.3 Change the unit by press button.
Pressure: kPa / bar /psi
Temperature: C/ F
6.5.4 Press button to save and exit.Press button to cancel and exit.
6.6 Printer
6.6.1 Inner printer
Instruction manual - 15 -
6.62 The sample of content of print and files in memory as below:
Instruction manual - 16 -
6.7 USB Flash memory (Optional)
If you want to store the information of program cycle in flash memory you
need to insert the flash in the usb socket before the program end.
The information will be stored into files. The name of file is according to the Number
of machine and the cycle number.
Instruction manual - 17 -
7. Maintenance
Frequency Operation
Daily Cleaning the door seal
Cleaning the external surface
Weekly Cleaning the reservoir
Cleaning the chamber
Every year Replace the door seal
7.1 Clean the distilled water tank
every week with medical disinfectant .
7.2 Clean the chamber weekly.
7.2.1 Remove the trays and rock from the
chamber.
7.2.2 Clean the chamber with non-plush cloth
saturated with distilled water.
7.2.3 Apply the same procedure for the trays and rock.
7.3 Replacement of the bacteriological filter
7.3.1 The bacteriological filter is at the back of the sterilizer.
7.3.2 Unscrew the filter by hand (anti-clockwise).
7.3.3 Replacing the bacteriological filter.
7.3.4 Screw the new filter by hand clockwise.
Instruction manual - 18 -
7.4 Cleaning the door seal
Clean the door seal weekly, with non-plush cloth saturated with the distilled water.
7.5 Replacement of the door seal
7.5.1 Fully open the door.
7.5.2 Remove the door seal ring carefully by hand.
7.5.3 Clean the door seal ring carefully with a non-plush cloth saturated with distilled
water.
7.5.4 Moisten the new seal ring with medical disinfectant .
7.5.5 Insert the new seal ring and press in sequence as the following.
Instruction manual - 19 -
Caution: Please ensure the chamber and the door has been cool down before you
replace the seal ring.
7.6 Door adjustment
On normal circumstance the chamber door lock don't need to adjust.Once
steam leaking occurs (the seal fails), you may use the spanner to adjust door seal.
7.6.1 Open the door firstly.
7.6.2 Insert the spanner into the gap beneath the plastic cover; use the spanner to
Instruction manual - 20 -
lock on the adjusting nut (Fig 1). Turn the nut counter clockwise as the figure below
(Fig 2). This will tighten the sealing plate.
7.6.3 Turn the nut until the sealing plate is tight. If the door knob is too tight, you
may also turn the nut clockwise to loosen it.
Caution:
Never try to readjust the chamber door while the door is locked.
8 Transportation and Storage
8.1 Switch off the sterilizer before transportation or storage. Pull out the plug to let
the machine cool down.
8.2 Drain the distilled water tank and the used water tank.
8.3 Conditions for transportation and storage:
Temperature: -20 ℃ ~ +55℃
Relative humidity: ≤85%
Atmospheric pressure: 50kPa~106kPa
Instruction manual - 21 -
9 Alarm
Instruction manual - 22 -
10 Safety devices
(1) Main fuses
Protection of the whole equipment against possible failures of the heating resistor .
Action: Interruption of the electric power supply.
(2) Thermal cutouts on the mains transformer windings
Protection against possible short circuit and mains transformer primary winding
overheating .
Action: Temporary interruption (up to the cooling) of the winding.
(3) Safety valve
Protection against possible sterilization chamber over-pressure .
Action: release of the steam and restoration of the safely pressure.
(4) Safety micro-switch for the door status
Comparison for the correct closing position of the door .
Action: signal of wrong position of the door.
(5) Manually reset thermostat on chamber heating resistors
Protection for possible overheating of the chamber heating resistors .
Action: Interruption of the power supply of the chamber resistors.
(6) Manually rest thermostat on steam generator
Protection for possible overheating of the steam generator .
Action: Interruption of the power supply of the steam generator.
(7) Door safety lock
Instruction manual - 23 -
Protection against accidental opening of the door.
Action: Impediment of the accidental opening of the door during the program.
(8) Self-leveling hydraulic system
Hydraulic system for the natural pressure leveling in case of manual cycle
interruption, Alarm or black-out .
Action: automatic restoration of the atmospheric pressure inside chamber.
Instruction manual - 24 -
APPENDIX 1
Characteristics of the feeding water
Instruction manual - 25 -
APPENDIX 2
DIAGRAMS OF THE STERILIZATION PROGRAMMES
Max.load per
Temperature
time(min.)
Total time
Max.load
total(Kg)
tray(Kg)
Pressure
（bar）
Holding
（℃）
(min.)
Program Type
134 2.10 4 15~20 4.5 1.25
SOLID Unwrapped solid material
121 1.10 20 30~45 4.5 1.25
134 2.1 4 30~40 Unwrapped hollow material 3.0 1
WRAPPEN
121 1.0 20 35~50 Single-wrapped solid material 3.0 1
Unwrapped porous material 1.2 0.4
Single-wrapped porous material 0.9 0.3
Dual-wrapped porous material 0.75 0.25
PRION 134 2.1 18 45~60
Single-wrapped hollow material 4.5 1.25
Dual-wrapped solid and hollow 1.5 0.6
material
DRYING 115 -0.75 4-20 - - -
B&D Test 134 2.1 3.5 22~35 - -
HELIX Test 134 2.1 3.5 22~35 - -
Vacuum Test - - - 15~20 - -
134 2.1 8 45~65 Wrapped liquid 1.5 -
LIQUID
121 1.1 30 50~75 Wrapped liquid 1 -
PLASTIC 105 0.2 30 20~65 Unwrapped plastic 1 3
The time required for sterilizer to be ready for routine use after the power is switched
Instruction manual - 26 -
on less than 5 minutes.
The max. temperature of the 134℃ sterilization cycle is 136℃
The max. temperature of the 121℃ sterilization cycle is 123℃
Instruction manual - 27 -
Instruction manual - 28 -
Instruction manual - 29 -
Instruction manual - 30 -
APPENDIX 3
ELECTRICAL DRAWING
Instruction manual - 31 -
APPENDIX 4
Instruction manual - 32 -
HYDRAULIC DRAWING
Instruction manual - 33 -
