QA11-0032 Sting 11B Standard - Operation Manual V1.3E Apr.2013
QA11-0032 Sting 11B Standard - Operation Manual V1.3E Apr.2013
QA11-0032 Sting 11B Standard - Operation Manual V1.3E Apr.2013
OPERATION MANUAL
1
PARA. NO. FIGURE DESCRIPTION PAGE NO.
8.2 Printer Output 35
8.3 Printer Specification and Handling 36
8.4 Printer Paper Loading 37
9 User Interface 38
9.1 GUI 38
9.2 Main Screen 39
9.2.1 Standby Screen 39
9.2.2 Displayed data on Standby Screen 40
9.3 Keys on Main Screen 41
9.4 System Setup 42
9.4.1 Setting the Language 43
9.4.2 Adjust LCD contrast 44
9.4.3 System Clock 45
9.5 Selecting the cycle 46
9.6 Cycles Descriptions 47
9.6.1 Cycle no. 1 - Flash 48
9.6.2 Cycle no. 2 - Unwrapped 49
9.6.3 Cycle no. 3 - Wrapped 50
9.6.4 Cycle no. 4 - Prion 51
9.6.5 Cycle no. 6 - Porous 52
9.6.6 Cycle no. 8 – Bowie & Dick test 53
9.6.7 Cycle no. 9 – Leak test 54
9.7 Starting the cycle 55
9.8 Typing the code 55
9.9 On-process screen 56
9.9.1 Displayed data on Process Screen 56
9.10 System messages 57
9.10.1 Information process and system status Messages 57
9.10.2 Status messages 57
9.10.3 Fail messages 59
9.11 Modifying system parameters 63
10 Monitoring system's I/O 66
10.1 Digital I/O 66
10.2 Analog Inputs 67
11 Maintenance Instructions 68
11.1 Preventive and Scheduled Maintenance 68
11.2 Operator's Tasks 68
11.3 Technician's Tasks 69
11.4 Cleaning Procedures 70
11.5 Replacement of consumables 72
12 Troubleshooting 74
12.1 Display Calibration 76
13 Maintenance Diary 77
2
Figure Content
FIG. NO. FIGURE DESCRIPTION PAGE NO.
Fig. 1- Overall Dimensions 13
Fig. 2- Polyphosphate Filter 15
Fig. 3- Reverse Osmosis System 15
Fig. 4- Autoclave Front View 17
Fig. 5- Autoclave Rear View 18
Fig. 6- Thermostat parameters 19
Fig. 7- Safety valve parameters 19
Fig. 8- Safety pressure switch 20
Fig. 9- Placing the device 23
Fig. 10- Power Inlet 24
Fig. 11- Elevation and atmospheric pressure chart 26
Fig. 12- Placing instruments on trays (illustration) 29
Fig. 13- Wrapped Instruments 30
Fig. 14- Filling the water reservoir 32
Fig. 15- Draining the reservoirs 33
Fig. 16- Connecting the drain tube 33
Fig. 17- Disconnecting the drain tube 33
Fig. 18- Paper loading 37
Fig. 19- System Status Screen 39
Fig. 20- Standby Screen 40
Fig. 21- Main Menu Screen 42
Fig. 22- Language Screen 43
Fig. 23- Contrast Screen 44
Fig. 24- Set Clock Screen 45
Fig. 25- Select Cycle Screen 46
Fig. 26- Code Screen 55
Fig. 27- On-process Screen 56
Fig. 28- Error Screen 59
Fig. 29- Menu Screen 63
Fig. 30- Parameters Screen 64
Fig. 31- Set Parameters Screen 65
Fig. 32- Digital Inputs/Outputs Screen 66
Fig. 33- Analog Inputs Screen 67
Fig. 34- Chamber Filter 71
Fig. 35- Filter and mesh 71
Fig. 36- Replacing the Air Filter 72
Fig. 37- Replacing the Door Gasket 73
Fig. 38- System Reset Screen 76
Fig. 39- Screen Calibration 77
3
1. General Information
1.1 Introduction
This table-top autoclave is designed for sterilization of medical and
surgical materials such as unwrapped and wrapped, solid, hollow
and porous products and goods that are defined as hollow in
ophthalmic dental and medical clinics, first aid rooms, small
laboratories, etc.
This autoclave model is an electrically heated sterilizer using steam
as a sterilizing agent.
The autoclave is classified as Class IIb according to MDD 93/42/EEC.
The autoclave is designed as a Small Steam Sterilizer Type B in
accordance with EN13060 and as Class I in accordance with
EN60601-1, continuously operated, ordinary equipment without
applied parts and without signal input-output parts. The device is
not intended for use in the presence of flammable mixtures.
This model is a pre-vacuum sterilizer having the following features;
4
The advantages of the pre-vacuum sterilizer are as follows:
Removal of air pockets from packs and porous load and most
kinds of hoses (rubber, plastic etc.) by vacuum at the first stage
of the cycle.
Better steam penetration into the load; resulting in effect ive
sterilization.
Better temperature uniformity.
Better drying of materials due to the vacuum achieved in the
chamber at the end of the sterilization cycle.
5
1.2 General
The Autoclave should be used as described in this manual only.
The following are the Instructions before operating the autoclave:
1.4 Warranty
We certify that this instrument is guaranteed to be free from defects
in material and workmanship for one year against faulty
components and assembly with the exception of glassware, lamps
and heaters.
The warranty does not include and does not replace routine
treatment and preventive maintenance, to be performed according
to instructions in paragraph 11 (Maintenance Instructions).
6
Warranty Statement
The warranty registration must be completed and returned to our
service department within fourteen (14) days of purchase or the
warranty will be void!
Under the warranty period, the packaging material must be
retained or the warranty will be void!
Note:
If there is any difficulty with this instrument and the solution is not
covered in the Technician Manual, contact our representative or us
first. Do not attempt to service this instrument by yourself. Describe
the difficulty as clear as possible so we may be able to diagnose
the problem and provide a prompt solution.
In case you call for technical assistance please have the following
details available in order to help you as efficient as possible:
Autoclave Model
Autoclave Serial Number
Autoclave Software version
Printout of the faulty cycle if the machine is equipped with
printer or memory card.
7
1.5 Safety Instructions
Do not touch the mains plug or power cord with wet hands.
There is a danger of electric shock.
Do not unplug the power cord out by pulling the cable only. If
the cord is damaged, it may cause electric shock.
8
1.6 Symbol Description
Warning Sign:
This sign indicates the need of caution.
Reading accurately all these notes beside
this sign is obligatory.
Protective earth (ground):
To identify any terminal which is intended for
connection to an external conductor for protection
against electrical shock in case of a fault, or the
terminal of a protective earth (ground) electrode
Hot Surface:
This sign informs about hot surface.
The hazard warning symbol of Hot Surface
indicates a potential personal injury of burning
hazard.
High Voltage:
This sign informs about High Voltage area.
The hazard warning symbol of Danger High
Voltage indicates a potential personal injury of
electrical shock and electrical burning hazard.
9
2. System requirements
Warning!
The electrical source line impedance shall be ≤ 0.1 Ω ! Verify that the
power is cut before starting the connection of the cables!
Caution!
Waste water should be brought into the public net in accordance with
the local rules or requirements.
Only non-hazardous liquids shall be disposed in public sewage!
10
11
2.3 Environment Emission Information
Warning!
Verify that the power is cut before starting the connection of the cable!
12
2.5 Specifications
13
2.5.1 Overall Dimensions
475.0
475.0
451.0
451.0
24.0
24.0
609.0
609.0
91.0 518.0
609.0 91.0 518.0
609.0
0 518.0
91.0 518.0
534.0
534.0
2.5.2 Construction
The main parts of the autoclave are made of materials as indicated below:
14
2.5.3 Water Quality
The mineral free water supplied to the autoclave should have the
physical characteristics and maximum acceptable level of
contaminants indicated in the table below:
Attention:
The use of water for autoclaves that does not comply with the table
above may have severe impact on the working life of the sterilizer
and can invalidate the manufacturer’s guarantee.
The aforementioned requirements concerning the water supply are
also valid for steam supplied from boilers installed at the customer’s
site, which enter the sterilizer chamber and come in contact with the
products or packaging.
15
Water for Liquid-Ring Vacuum System (optional)
The feed water supplied to the liquid ring ejector must meet the
following requirements:
Hardness: 0.7 - 2 mmol/l, 4-12 °(German) of CaCO 3 ,
7.2-21°(French) of CaCO 3 , 72- 215 mg/l of CaCO 3
Polyphosphate Filter
This model is an economic anti-scale system, based on polyphosphate salts.
Recommended to install the filter between the tap water supply and the tap
water income of the autoclave (see item 4 in fig. 5) to improve the quality of
the incoming tap water.
Note:
The use of heavy scaled water for the vacuum pump cooling, can
cause blocking of the rotor and put the pump out of operation.
This invalidates the guarantee for the vacuum pump.
16
2.6 Directives and Standards:
17
3 Detailed Interface of the Autoclave
Front View:
9 3
1 2
7
15
10
14
11 13
12 4 5 6
18
Rear View
3
2 6
7 4 5
1
19
4 Safety devices
SPECIFICATION VALUE
Max. ambient temperature T150
Rated voltage and current 16(3)A-250V
Work range 50°C - 320°C
Tolerance on max temperature 3K - 12K
Resetting differential 30% intervention temp.
Temperature change speed 1K/ min.
Features of automatic action 28 KN
Minimum current 200 mA
Minimum bending radius of the capillary 5 mm
Approved VDE (DIN EN 60730) 1
Situation of pollution normal situation
Built in accordance with the rule EN 60730
Weight 65 gr. approx
20
Safety Pressure Switch Type LF25
This safety component prevents the operator from door opening if
the chamber is pressurized.
SPECIFICATION
Model LF25
Medium Non-hazardous gas, liquid or steam
Operating Pressure 0.2-0.6 bar
Proof Pressure 3bar
Differential 0.2 +/- 0.1bar
Operating Temperature
Range +85°C / +125°C Maximum
Contact Arrangement SPDT
Electric Rating SPDT / Normal Close: 16(4) A-250VAC
Terminal 6.35mm
Connection NPT 1/4 male
21
4.1 Door Safety System
Do not force to open the door – force will only damage the
autoclave and can cause loss of guarantee!
Explanation:
First the door triggers the pin near the upper hinge, which starts the
motor to operate just before the nut reaches the screw. In the next
step, the operator must press the close door icon on the screen. The
motor starts to pull the door in, until the door closed micro switch is
actuated by the pin that is on the front panel by the screws upper
side. When steam is introduced inside the vessel, the pressure switch
gets actuated and thus releases a normally closed connected serial
to the motors power supply, so the electricity is cut from the motor.
Since the threads are designed to be self-closing, there cannot be
torn from any force nor from the pressure.
The motor is only operable if the vessel has atmospheric pressure
(see para. 5.4- Setting Atmospheric pressure parameter).
22
5 Installation
5.1 Mounting
After unpacking the autoclave, check that the Serial Number (S/N) on
its nameplate corresponds with the package number.
The rear legs of the autoclave are set lower to give the
chamber an inclination of 2 ° towards the back, to ensure that
water is completely drained out from chamber through the
opening on the bottom on the back of the chamber .
23
Fig. 9- Placing the device
24
5.2 Power connection
The Wall outlet for the Power Supply (230V 50/60 Hz,
16A) should be equipped with a matching earthing –
at least #12AWG (2.5 mm²).
25
5.3 Lifting and carrying
Caution!
Before moving the autoclave, make sure there is no pressure in the
chamber!
Caution!
Let the device cool down before moving it to another location!
Caution!
Before moving the autoclave, make sure that the chamber’s door is
closed and locked!
Do not try to pull/lift the device from the box with bare hands
(70kg). To avoid injuries, lifting and carrying should be done by
at least two (2) people.
26
5.4 Setting Atmospheric pressure parameter
MENU
OPTIONS
TECHNICIAN CODE
CHANGE
PARAMETERS
ATMPressue
27
6 Preparation before Sterilization
6.1.1 Safety
Protective equipment and clothes and other safety instructions
should be implemented in accordance with local and national
regulations and/or rules!
For proper sterilization - Do not overload the chamber. Only
autoclavable products shall be used; please re fer to the
manufacturer instructions for sterilization of unknown materials or
instruments.
6.1.2 Loading
Correct loading of the autoclave is essential for successful
sterilization for several reasons. Efficient air removal from the
chamber and the load will permit total steam penetration and
saturation, and allow proper drainage of condensate. Additionally,
correct loading will reduce damage to packs and their contents
and maximize efficient use of the sterilizer. Fo r detailed loading
instructions (see para. 6.2 Preparation of Instruments).
6.1.3 Unloading
On completion of the cycle, the load shall be removed from the
sterilizer and a visual inspection shall be made to assure that the
load is dry, and that sterilizing indicators have made the required
color change.
28
6.2 Preparation of Instruments
29
6.2.1 Packs
6.2.2 Tubing
When placing in a tray, Make sure that both ends are open,
without sharp bends or twists.
30
6.2.3 Wrapped Instruments
31
7 Operating Instructions
Open the water reservoir cap. Pour distilled water into the
reservoir through the opening on top of the device, until “Stop
Filling Water” message appears on the screen along with the
interrupted noise of the buzzer (see para. 7.2- Filling the Water
Reservoir). The amount of the filled water is approximately 4
liters (1,1 gallons).
Insert the power plug into the socket (see item 2 in Fig. 5).
Turn on the power switch mounted on the front panel, to
power the unit (see item 13 in Fig. 4).
The Autoclave will be ready for use within 12 minutes.
Set the clock for the proper date and time (see para. 9.4.3-
System Clock).
Select required cycle (see para. 9.5- Selecting the cycle).
Load the sterilizable material into the chamber (see para.
6.1.2- Loading).
Close the door by pushing; the Autoclave will display a "Ready"
message or "Wait" if the steam is not ready (see para. 9.10-
System messages).
Press the "Start" key to start the sterilization cycle (see para.
9.7- Starting the cycle).
At the end of the cycle, a "Cycle End" message will be
displayed and the buzzer will buzz continuously for 10 seconds.
In case of a failed cycle, the diagnosis of the failure followed
by a "Fail!" message will be displayed and printed, and the
buzzer will make an interrupted noise.
Open the door by pressing the "Door" button and unload the
sterilized materials from the chamber (see para. 6.1.3- Unload).
In case of fail, press the "Reset" ke y to cancel the locking of
the door. Type Operator’s code (“1”) to erase error message
(see para. 9.8- Typing the code).
32
7.2 Filling the Water Reservoir
Take out the small cover of the Mineral Free Water Reservoir from
the top of the Autoclave. Pour distilled water into the reservoir
through the opening on top of the device, until “Stop Filling Water”
message will be displayed on the screen.
(Minimum water amount: approximately 4 liters / ~1.1 gallons)
Caution!
Under no circumstance should water be filled above the safety
valve holder!
33
Fig. 14- Filling the Water Reservoir
Caution!
At least once a week, empty the "Used Water" Reservoir.
Before starting, make sure that the electric cord is disconnected
and there is no pressure in the autoclave .
Caution!
The water contained in the
Used-Water Reservoir, after
sterilization process, is un-
sterilized water, and should be
treated as such!
34
Fig. 16- Connecting the drain tube
8 Cycle Recording
8.1 Printer
The autoclave is equipped with a character printer, which prints a
detailed history of each cycle performed by the device (for the
record or for subsequent consideration).
35
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 “CYCLE ENDED.” for a complete cycle or “FAIL” for an
aborted cycle.
For an example of a typical printout, see next page.
Legend
V - Vacuum stage
S - Sterilization stage
E - Exhaust stage
H - Heating stage
F – Fail
D - Drying
36
8.2 Printer Output
Printout Layout Printout Legend
Operator: __________ Operator: ________ Operator's Signature
Time: 17:29:22 Time: 17:29:22 Time Index
Date: 06.01.2011 Date: 06.01.2011 Date Index
Min Temp: 134.2°C Min Temp: 134.2°C Minimum temperature reached during cycle
Max Temp: 135.2°C Max Temp: 135.2°C Maximum temperature reached during cycle
CYCLE ENDED! CYCLE ENDED! Cycle final status index
Current cycle phase: Current Current
Current Pressure
D= Drying Stage Elapsed Temperature
D 00:24:47 077.8 041.0 D Time
00:24:47 077.8 041.0
D 00:23:40 101.4 099.7 D 00:23:40 101.4 099.7
Current cycle phase:
E= Exhaust Stage
E 00:23:31 103.1 102.0 E 00:23:31 103.1 102.0
E 00:22:31 135.2 313.5 E 00:22:31 135.2 313.5
Current cycle phase:
S= Sterilization Stage
S 00:22:31 135.2 313.5 S 00:22:31 135.2 313.5
S 00:21:31 135.1 315.3 S 00:21:31 135.1 315.3
S 00:20:31 135.1 315.0 S 00:20:31 135.1 315.0
S 00:19.31 134.2 319.1 S 00:19.31 134.2 319.1
Current cycle phase:
H= Heating Stage
H 00:16:50 073.9 059.9 H 00:16:50 073.9 059.9
Current cycle phase:
V= Vacuum Stage
V 00:16:50 073.7 056.2 V 00:16:50 073.7 056.2
V 00:16:47 074.2 020.5 V 00:16:47 074.2 020.5
V 00:15:03 103.4 102.9 V 00:15:03 103.4 102.9
V 00:14:19 116.1 182.8 V 00:14:19 116.1 182.8
V 00:13:35 075.9 022.2 V 00:13:35 075.9 022.2
V 00:12:05 102.5 102.5 V 00:12:05 102.5 102.5
V 00:11:22 116.0 179.8 V 00:11:22 116.0 179.8
V 00:10:29 064.3 022.0 V 00:10:29 064.3 022.0
V 00:08:49 093.3 102.9 V 00:08:49 093.3 102.9
V 00:08:10 104.4 183.2 V 00:08:10 104.4 183.2
V 00:02:16 040.7 025.4 V 00:02:16 040.7 025.4
Time °C kPa Time °C kPa
Dry Time: 001.0min Dry Time: 001.0min Drying time of the selected cycle
Ster Time: 003.0min Ster Time: 003.0min Sterilization time of the selected cycle
Ster Temp: 134.0°C Ster Temp: 134.0°C Sterilization temperature of the selected cycle
Cycle: 1-Flash Cycle: 1-Flash Name of the selected cycle
Load Number: 00002 Load Number: 00002 Number of the executed cycles
Ver: Screw-D 1.48 Ver: Screw-D 1.48 Name and software version of the touch screen
Ser.Num: 01101223 Ser.Num: 01101223 The serial number of the Autoclave
Time: 17:04:35 Time: 17:04:35 Time Index
Date: 06.01.2011 Date: 06.01.2011 Date Index
37
8.3 Printer Specification and Handling
Do not pull out the paper roll from the paper insertion opening.
Use only the 57,5mm wide paper rolls, supplied by your dealer.
38
8.4 Loading paper
1. Pull out the front cover and place the paper roll in its
receptacle
2. Insert the end of the paper roll in the slit of the printer
3. Press the FEED button until a few centimeters come out of the
printer.
4. Make sure that the paper roll remains in its receptacle in the
right position
5. Put the frontal cover back to its place.
39
9 User Interface
Foreword
The intent of this section is to provide information about the ROSE
control system's Graphic User Interface. This paragraph will:
Provide a general overview of the GUI.
Explain how to operate the control system and how to perform all
available actions using GUI.
List all existing textual and graphic messages and indicators
which the system provides.
GUI Overview
Keypad
The GUI has an integrated keyboard used for user input.
GUI structure
The GUI is based on screens. A Screen is what is displayed on the LCD
in a given time. A Screen presents useful information such as
temperature, textual messages, icons etc. A Screen also contains
required keys. Based on the system process, the screens will be
changed. In this case the GUI will display required information and will
allow required input from the user.
40
9.2 Main Screen
The Main screen enables basic User-Machine interaction. The main
screen displays the data when the device is on standby mode and
displays different data when the system performs sterilization process.
Status indication
If the machine is not ready to perform a sterilization process, the
reason will be displayed on Stand-by screen. In this case, the ‘START’
key is unavailable. If the device is ready to perform a sterilization
cycle, “Ready” message is displayed and ‘START’ key is visible.
41
9.2.2 Displayed data on Standby screen
Message – In this line the user will get informative messages, faults
results and instructions.
Load Number – the total cycle counter, in every running this value will
be increased by one. The counter is used to determine the
maintenance status of the autoclave.
Chamber
Pressure
Load
Number
Cycle Select
42
9.3 Keys on the main screen
Select Cycle
Pressing this key will display ‘Select Cycle’ screen, which enables
changing current cycle. This key is enabled only when the device is on
standby mode.
Open Door
This key is available on standby, when inside conditions (pressure and
temperature) are not dangerous. Pressing this key will open the
autoclave's door.
Reset Error
This key is displayed when the device is on standby and an
Error/Failure occurs. Pressing this key will reset the error and will return
the device to normal mode. (In some cases, pressing this button will
display ‘ENTER CODE’ screen, if the error reset is allowed to an
authorized personnel only).
Menu Key
Pressing this key will show the ‘MENU’ screen. It enables setup of the
system.
43
9.4 System Setup
44
9.4.1 Setting the language
a. On the main screen press the key. This will display the
‘MENU’ screen.
45
9.4.2 Adjusting LCD contrast
a. On the main screen press the key. This will display the
‘MENU’ screen.
46
Pressing the key will save the changes.
9.4.3 Setting the system's clock
a. On the main screen press the key. This will display the
‘MENU’ screen.
b. On the Menu screen press the key. This action will display
the ‘SET CLOCK’ screen:
47
Pressing the key will exit the ‘SET CLOCK’ screen without
saving.
9.5 Selecting the Cycle
48
9.6 Cycles Descriptions
The autoclave offers 9 different cycles: 6 sterilization cycles, 2 test
Cycles and 1 dry only cycle.
Note: Cycles No. 5 and 7 is not applicable for medical clinics and
will not be described.
ATTENTION!
The unit is equipped with an automatic flushing system. After every
50 cycles (factory preset value), the machine will go into a special
cycle, called "FLUSH". During this cycle, the water is removed from
the steam generator with the help of the steam pressure (a specific
sound is heard). This will remove the remaining particles or
contaminants from the steam generator, allowing the unit to wo rk
under equal conditions, in the sense of the quality of the steam
and, consequently, of the sterilization.
49
9.6.1 Cycle no. 1
Flash 134°C /3 min (Warm Up).
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are controlled at the
required sterilization level for the sterilization time.
Fast exhaust; steam is rapidly exhausted from the chamber;
followed by a vacuum pulse, and air inlet until pressure equalizes
atmospheric pressure.
The allowed material for the cycle is solid unwrapped instruments.
50
9.6.2. Cycle no. 2
Unwrapped 134°C /3 min (Class B)
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are con trolled at the
required sterilization level for the sterilization time.
Fast exhaust stage; steam is rapidly exhausted from the chamber;
followed by a vacuum pulse, and air inlet until pressure equalizes
atmospheric pressure.
The allowed materials for the cycle are unwrapped instruments.
51
9.6.3. Cycle no. 3
Wrapped 134°C /3:30 min (Class B)
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are controlled at the
required sterilization level for the sterilization time.
Fast exhaust stage; steam is rapidly exhausted from the c hamber,
Drying stage; vacuum is created in the chamber for 20 min.
Air inlet phase; Filtered air enters the chamber breaking the
vacuum to enable the door to open.
The allowed materials for the cycle are wrapped instruments.
52
9.6.4. Cycle no. 4
Prion 134°C /18 min (Class B)
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are controlled at the
required sterilization level for the sterilization time.
Fast exhaust stage; steam is rapidly exhausted from t he chamber,
Drying stage; vacuum is created in the chamber for 20 min.
Air inlet phase; Filtered air enters the chamber breaking the
vacuum to enable the door to open.
The allowed materials for the cycle are wrapped instruments.
53
9.6.5. Cycle no. 6
Porous 121°C /20 min (Class B)
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are controlled at the
required sterilization level for the sterilization time.
Fast exhaust stage; steam is rapidly exhausted from t he chamber,
Drying stage; vacuum is created in the chamber for 20 min.
Air inlet phase; Filtered air enters the chamber breaking the
vacuum to enable the door to open.
The allowed materials for the cycle are textile materials.
54
9.6.6. Cycle no. 8
Bowie and Dick test 134°C /3:30 min (Hollow load A)
Cycle Sequence
Conditioning: four vacuum pulses to remove the air from the
chamber, steam is introduced into the chamber until the
sterilization temperature is reached.
Sterilization stage: temperature and pressure are controlled at the
required sterilization level for the sterilization time.
Fast exhaust stage; steam is rapidly exhausted from the chamber;
followed by a vacuum pulse, and air inlet until pressure equalizes
atmospheric pressure.
55
9.6.7. Cycle no. 9
Leak test (Vacuum test).
Operations Sequence
Vacuum is produced in the chamber for a preset pressure. When
the pressure in the chamber reaches P1, the vacuum pump
stops (P1 is the lowest level that can be reached in this test).
A test is done 5 minutes later, at this time P2 -P1 should be less
than 8.5 kPa.
A second test is done after 10 min.: P3 -P2 must be less than 1.3
kPa (13mBar) to ensure a leakage rate of less than 1.3mBar/min.
Before starting a vacuum test, that the door gasket and chamber
are completely dry. There MUSTN’T be any water drops between
the lip of the gasket and the dome. The lip MUSTN’T be glued to
the dome’s flange!
The chamber MUSTN’T contain any tray or tray holder or material
within!
Should the above precautions not be implemented, the vacuum
test is likely to fail!
56
9.7. Starting the Cycle
The cycle start is performed from the 'MAIN' screen. Press the
key to start the selected cycle.
57
9.9. On-Process Screen
This screen is displayed when the device is performing the sterilization
process. All relevant data during the process is displayed on this
screen.
Chamber
Temperature
Chamber
Pressure
Process
Timer
58
9.10. System messages
9.10.1. Information process and system status messages
'Not ready' messages indicate the device's status on standby. If one
of the ‘Stand-by’ messages is displayed, the ‘START’ button is
unavailable and it is not possible to start a new cycle.
'Status messages' are displayed in order to monitor the device's status
and cycle progress.
Fill Water
This message is displayed when the clean water reservoir is empty.
The message disappears after adding water.
Remove Water
Remove water from used water reservoir. This message is displayed
if the used water reservoir is full. The message disappears after
removing the water.
Coil is cold
The coil temperature is too cold and not ready for the cycle. The
message disappears when coil temperature is above required
temperature.
No Steam
This message is displayed if the generator pressure is too low. The
message disappears when the pressure is above required pressure.
Ready
This message is displayed on standby stage when the de vice is ready
to start a new cycle.
FAIL
This message is displayed on standby stage when sterilization cycle
fails.
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Door Open
This message is displayed on standby stage when the door is open.
Opening Door
This message is displayed on standby stage when the door is on
unlocking process.
Creating Vacuum
This message is displayed on Pre vacuum stage when the system
creates vacuum in the chamber.
Vacuum Stay
This message is displayed on Pre vacuum stage when the system holds
required vacuum in the chamber.
Steam On
This message is displayed on Pre vacuum stage when the system
creates pressure in the chamber.
Exhaust On
This message is displayed on Pre vacuum stage when system removes
pressure from the chamber.
Heating to Ster.
This message is displayed on Heating stage when the system creates
sterilization conditions.
Sterilizing
This message is displayed on Sterilization stage.
Exhaust
This message is displayed on Exhaust stage.
Dry
This message is displayed on Drying stage.
CYCLE END
This message is displayed when a sterilization cycle successfully ends.
TEST ENDED
The message is displayed when Leak Test is finished.
60
9.10.3. Fail Messages
System errors are displayed on the main screen. When the
device is on process, the error will disrupts the sterilization cycle.
Reset error operation is required in order to bring the system to
the normal mode.
Error/Failure
61
Error Messages
01-Temp1 Cut.
This message is displayed when the Chamber Temperature
sensor fails.
02-Low Temp.
The temperature drops for more than 5 seconds below the
sterilization temperature during ‘Sterilize’ stage.
03-High Temp.
This error occurs in one of the following cases:
Heating and Pre-vacuum Stages:
If chamber temperature is higher than ‘Limit Temperature’ for
more than 10 seconds.
Sterilization Stage:
If temperature rises to 3°C (6°F) above sterilization temperature
during the sterilization stage for 10 seconds.
04-Exh Valv.Err.
This error may occur on Standby or Exhaust stages when
removing pressure from the chamber takes a long time.
06-Press2 Cut.
This message is displayed when the Generator Pressure sensor
fails.
07-High Pressure
This message is displayed if the Chamber Pressure raises 40 kPa
above sterilization pressure during the sterilization stage.
62
08-Low Pressure
This message is displayed if the Chamber Pressure drops 10 kPa
below sterilization pressure during the sterilization stage.
11-Door Open
This message is displayed if during the sterilization process the
system detects that the door is not closed.
12-Manual Stop
This message is displayed if the sterilization cycle is aborted after
the 'STOP' key is pressed.
13-Air Error
This message is displayed on Standby when the system fails to
break the vacuum in the chamber.
14-Low Vacuum
This message is displayed if the system can't create required
vacuum conditions in the chamber after 20 minutes.
15-Low Heat
This message is displayed if the system can't create required
pressure conditions in the chamber after 20 minutes during the
Pre vacuum and Heating stages.
63
16-Press1 Cut
This message is displayed when the Chamber Pressure sensor
fails.
17-No Gen.Source
This message is displayed when the Water supply to the Steam
Generator fails.
18-Doors Sw Err
This message is displayed when the door switches are in an
abnormal position.
21-Test Fail
This message is displayed when Leak Test cycle or BD-Test cycle
fails.
64
9.11. Modifying system parameters
a. On main screen press the key. This will display the ‘MENU’
screen.
65
c. Browse the menu list using the keys and select
'Change Parameters' option.
66
f. Press the key to submit the selection. ‘SET PARAMETER’
screen will be displayed:
67
10. Monitoring System’s I/O
The GUI enables to view system’s I/O. The system has analog
inputs, digital inputs and digital outputs.
68
10.2 Analog Inputs
a. On the main screen press the key. This will display the
‘MENU’ screen.
69
11. Maintenance Instructions
Caution!
Read Safety Instructions (see para. 1.5 - “Safety Instructions”)
first before executing any preventive or corrective actions!
Clean Chamber x
Clean Chamber Accessories x
Clean Autoclave's Exterior x
operator
70
11.3. Technician’s Tasks:
71
11.4. Cleaning Procedures
Door Gasket: Spray alcohol to the lip of the gasket and clean it with a
soft cloth. The gasket should be clean and smooth.
Do not use steel wool or steel brush as this can damage the
gasket!
Trays and tray holder: Take out the tray holder and trays from the
chamber. Clean the tray holder and trays with a cleaning detergent
& water and with a cloth or sponge. You may use diluted lemon acid
(25-50 CC lemon acid in 1 liter of water) as cleaning detergent. If
detergent is used, rinse the tray holder and trays immediately with
water to avoid stains on the metal.
Do not use steel wool or steel brush as this can damage the
trays or the tray holder!
72
Chamber exhaust filter: Take out the chamber exhaust filter from the
chamber. Clean the chamber exhaust filter with a cleaning detergent
& water and with a cloth or sponge. You may use diluted lemon acid
(25-50 CC lemon acid in 1 liter of water) as cleaning detergent. If
detergent is used, rinse the chamber exhaust filter immediately with
water to avoid stains on the metal.
Do not use steel wool or steel brush as this can damage the
trays or the tray holder!
73
11.5. Replacement of consumables:
74
Silicon Door Gasket
The Door Gasket is used as a sealing between the chamber and the
door dome. It is necessary to replace the sealing in every half year
period in order to keep the autoclave in good condition and ensure
its maximum performance.
3. Place the new gasket into the socket of the door dome
4. Verify that the lip of the gasket is installed around in the same
level
75
12. Troubleshooting
Display is blind
Verify if the main switch is turned into "ON" position (see para.
7- Operating Instructions).
Verify if the power cord cable is plugged into the electrical
socket (see para. 7- Operating Instructions).
Release used water from “drain tank” (see para. 7.3- Draining
Water).
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Leak test ends with FAIL message
Verify if the chamber is completely empty before commence
leak test
Verify if the chamber is completely dry before commence
leak test
Verify if the chamber's flange is clean and dry before
commence leak test
Verify if the door gasket is clean and dry before commence
leak test
Verify if the door gasket is in good condition and sealed
properly before commence leak test
77
12.1. Display Calibration Procedure
This situation occurs when the user touches the screen before
switching the unit on and holds it pressed while switching the unit on.
In this situation, the unit will automatically go to “screen calibration”
mode. Follow the on-screen instructions:
78
Once the above procedure has been carried out, the screen will
display “STORE” and the process will be successfully finished.
79
13. Maintenance Diary
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
80
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
81
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
82
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
83
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
84
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
85
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
86
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
87
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
88
Corrective and Preventive Actions √/X Remarks
Clean Chamber □
Clean Chamber Strainer □
Clean Steam Generator Electrodes
□
Clean Electrical Box □
Clean Valves □
Clean Door Closing Mechanism □
Lubricate Door Closing Mechanism □
Lubricate Door Hinges □
Check Safety Valve □
Check Thermostat □
Check Safety Pressure Switch □
□
1 Year Period
89