QA11-0032 Sting 11B Standard - Operation Manual V1.3E Apr.2013

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Sting 11 Standard Class B

Pre and Post Vacuum- Table Top Autoclave

OPERATION MANUAL

QA11-0032 V.1.3 Apr. 2013


Table of Content
PARA. NO. FIGURE DESCRIPTION PAGE NO.
1 General 4
1.1 Introduction 4
1.2 General 6
1.3 Incoming Inspection 6
1.4 Warranty 6
1.5 Safety Instructions 8
1.6 Symbol Description 9
2 System requirements 10
2.1 Storage and Transportation Conditions 10
2.2 Operating conditions 10
2.3 Environment Emission Information 11
2.4 Electromagnetic Compatibility (EMC) 11
2.5 Specifications 12
2.5.1 Overall Dimensions 13
2.5.2 Construction 13
2.5.3 Water Quality 14
2..6 Directives and Standards 16
2.6.1 Technical Standards 16
2.6.2 Quality Standards 16
3 Interface Details 17
4 Safety devices 19
4.1 Door Safety System 21
5 Installation 22
5.1 Mounting 22
5.2 Power Connection 24
5.3 Lifting and carrying 25
5.4 Setting Atmospheric pressure 26
6 Preparation before sterilization 27
6.1 Loading and unloading the Device 27
6.1.1 Safety 27
6.1.2 Loading 27
6.1.3 Unloading 27
6.2 Preparation of Instruments 28
6.2.1 Packs 29
6.2.2 Tubing 29
6.2.3 Wrapped Instruments 30
7 Operating instructions 31
7.1 Instructions for Use 30
7.2 Filling the Water Reservoir 32
7.3 Draining Water 33
8 Cycle recording 34
8.1 Printer 34

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;

An air removal stage (pre-vacuum), before starting the


sterilizing stage.
A post-sterilization drying phase, based on the combined
operation of heat and vacuum with air inlet pulses.

In order to improve the efficiency of the vacuum pump – capability


and speed– a heat exchanger is installed on the outlet piping of
the chamber.
The steam and condensate evacuated from the chamber passes
through a cooling coil immersed in the water reservoir.

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.

A printer is an optional addition to the autoclave. The printer prints


the preset and actual parameters of the cycle (temperature, time
and pressure/ vacuum).
This manual is intended for the user and gives the user a general
understanding of the instrument and the best ways to operate and
take care of it in order to obtain effective results.
After reading this manual, operating the autoclave will be easy.
However since this instrument is built with high technology sensitive
components, no attempt should be made by the user or any other
unauthorized person to repair or recalibrate it.
Only technical personnel having proper qualifications and holding
technical documentation (including a Technician Manual) and
adequate information are authorized to service t he device.

5
1.2 General
The Autoclave should be used as described in this manual only.
The following are the Instructions before operating the autoclave:

1.3 Incoming Inspection


Immediately upon reception of your product, the packaging
material shall be removed and must be preserved after careful
examination. Any occurring shipment-damage of the packaging
material or of the content (such as: scratched panel surfaces,
broken knobs, etc.) must be immediately reported at your dealer or
at the point of purchase.
All Celitron products are tested and inspected prior to shipment.

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).

Our obligation is limited to replacing the instrument or parts, after


our examination, if within one year after the date of shipment they
prove to be defective. This warranty does not apply to any
instrument that has been subject to misuse, neglect, accident or
improper installation or application, nor shall it extend to
autoclaves that 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!

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.

Our Technical Service Department can be reached at:

Celitron Medical Technologies Kft.


2600 Vác, Avar utca 5, Hungary
Phone: +36 27 512 267
Fax: +36 27 512 268
[email protected]

No autoclave will be accepted for repair without proper


authorization from us. All transportation charges must be paid both
ways by the owner. This warranty will be void if the autoclave is not
purchased from an authorized full service dealer.

7
1.5 Safety Instructions

Do not touch the mains plug or power cord with wet hands.
There is a danger of electric shock.

If the power cord or power outlet makes a noise, disconnect


the power cord from the wall outlet and contact a service center.
There is a danger of electric shock or fire hazard.

Do not use a damaged or loose mains plug or power cord or


power outlet. There is a danger of electric shock or fire hazard.

Plug the power cord firmly into the power outlet.


Failing to do so may cause fire hazard.

Do not unplug the power cord out by pulling the cable only. If
the cord is damaged, it may cause electric shock.

Do not bend the power cord excessively or do not place a


heavy object over the power cord. It is especially important to keep
the power cord out from wet surfaces. If the cord is damaged, it may
cause electric shock or fire.

Do not maintain the autoclave by yourself. Only qualified


service technicians can service the instrument who are authorized by
Celitron Medical Technologies Service Department.

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

2.1 Storage and Transportation Conditions

The environment ambient tempera ture should be in the range


of 5-35ºC and a relative humidity of 85% respectively.
The storage and transportation altitude shall not be over 2400
meters (ambient pressure shall not be lower than 76 kPa (11.02
psi)).
Equipment may be moved only with empty Water Reservoirs.

2.2 Operating Conditions

This device is for indoor use only!


It is recommended to use Fluorescent lighting. The stroboscopic
effect of the lighting should be minimized in the plant room by
the use of two tube fittings suitably adapted for this purpose or
by the use of two phases for the lighting circuits. The fittings
should be sited longitudinally between the sterilizers.
The sterilizer should be loaded only with autoclavable material!
The environment shall not exceed an ambient temperature of
35ºC and a relative humidity of 85% respectively.
The operation altitude shall not be over 2000 meters (ambient
pressure shall not be lower than 80 kPa (11.6 psi)).
It is recommended to perform a B & D cycle at the beginning of
each working day.

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

The peak sound level generated by the autoclave is less than


70db A with background noise of 60db A.
The total heat per hour transmitted by the autoclave is less
than 100Wh.
The Autoclave is not a source of electromagnetic emissions
for medical purposes. The level of the EMC Emissions was
tested by a certified laboratory according to the list of
relevant standards (see clause 2.10), and found to be in
compliance with the requirements.

2.4 Electromagnetic Compatibility (EMC)

The installation and the service of the sterilizer should consider


special precautions regarding EMC according to the information
provided in this user and service manual. (According to standard
EN 60601-1-2 paragraph 6.8.2.201-Instructions for use).

 Warning- The use of cables, pumps, transducers or any


other electrical elements other than those specified by
Celitron as replacement parts may result in increased
EMMISIONS or decreased IMMUNITY of the sterilizer.
 Warning- the sterilizer should not be used adjacent to or
stacked with other equipment.
 Warning-the sterilizer should not be connected to the
same power line with other equipment.
 Warning-Portable and mobile RF communications
equipment such as cellular phones can affect the
operation of the sterilizer.

Warning!
Verify that the power is cut before starting the connection of the cable!

12
2.5 Specifications

ITEM PARAMETER VALUE


Inner Dia. 261.0 mm (10.3")
Chamber (gross)
Depth 452.0 mm (17.8")
Inner Dia. 259.0 mm (10.2")
Usable chamber dimensions (net)
Depth 398.1 mm (15.7")
Chamber volume 23 lit. (6.1 gal)
Width 53.6 cm (21.1")
External dimensions Height 48.5 cm (19.1")
Length 62.1 cm (24.4")
Weight (net) 70 kg (152.1 lb)
Shipping weight 80 kg (176.3 lb)
Width 75 cm (29.5")
Shipping dimensions Height 68 cm (26.8")
Length 71 cm (28.0")
Mineral free water reservoir volume 6 lit. (1.32 gal)
Maximum dimensions (door open) Length 92.0 cm (36.2")
K 46.1 cm (18.1")
Distance between supporting legs
R 48.1 cm (18.9")
R-rear legs F-front legs
F 48.1 cm (18.9")
Maximum load for tray 1.0 kg (2.2 lb)
Maximum solid load 6.0 kg (13.2 gal)
Maximum textile load 2.0 kg (4.4 lb)
Max. Working pressure 2.7 bar (39 psi)
Min. Working pressure -0.9 bar (-13.5 psi)
Width 18.4 cm (7.2")
Tray dimensions Height 2.0 cm (0.78")
Length 39.0 cm (11.4")
Heaters power 2200/ 2900W
The installation category over voltage II
Pollution degree 2
Voltage fluctuation ±10%
Max. Water temp. at the reservoirs 65ºC (149ºF)
Max. total Heating spread in 1 hour 4325 kJ
Max. support Load with full reservoirs
29 n/cm²
and Generator & Coil
Max. support Load with full reservoirs,
34 n/cm²
chamber and Generator & Coil
Min. water quantity allowing the
4 L
cycle
Max. water consumption during cycle 1.175 L
Maximum total cycle time 75 min
Peak sound level 65dB

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

Fig. 1- Overall Dimensions

2.5.2 Construction
The main parts of the autoclave are made of materials as indicated below:

Chamber is built of stainless steel 316 Ti.


Door is made of steel alloy G17CrMoV 5 -10.
Trays are made of stainless steel 304.
Water reservoir is made of Polyethylene Linear (LLDPE) UL -94 V2.

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:

MATERIAL ALLOWED AMOUNT


Evaporate residue ≤ 10 mg/l
Silicium oxide, SiO2 ≤ 1 mg/l
Iron ≤ 0.2 mg/l
Cadmium ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l
Rest of heavy metals, excluding
≤ 0.1 mg/l
iron, cadmium, lead
Chloride ≤ 2 mg/l
Phosphate ≤ 0.5 mg/l
Conductivity (at 20 °C) ≤ 15 µs/cm
pH 5 to 7,5
Appearance colorless, clean, without sediment
Hardness ≤ 0.02 mmol/l

Compliance with the above data should be tested in accordance


with acknowledged analytical methods, by an authorized laboratory.

Suggested maximum limits of contaminants in and


specification for water for steam sterilization (see EN 13060,
Annex C- Suggested maximum limits of contaminants in and
specification for water for steam sterilization Table C.1 -
Contaminants of condensate and feed water)

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

The use of hard water is strictly forbidden!

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.

Working pressure: 8 bar max


Burst pressure: 35 bar max
Working temperature: 0°C + 50°C min/max
Suggested Flow Rate: Max 8/10 lt/min
Life test: 200.000 cicles from 0-10 bar Fig. 2 – Polyphosphate Filter

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.

Reverse Osmosis System (optional)

A Reverse Osmosis system must be used to


improve the quality of the water used to
generate steam into the autoclave
chamber. The use of mineral-free water will
contribute to better performance and
longer life of the autoclave. The system
must be installed between the tap water
source and the “Mineral Free Water Inlet”
of the autoclave (see item 5 in fig. 5). Fig. 3 – R.O System

16
2.6 Directives and Standards:

2.6.1 Technical Standards

Pressure Equipment Directive 97/23/EC (PED);


Medical Device Directive 93/42/ EEC;
EN 61326: 1997 + A1(98) + A2(01) + A3(03), minimum immunity
requirements, Class A;
IEC 60601-1:2005+CORR. 1 (2006)+CORR. 2 (2007), IEC 60601 -
1-2:2007, IEC 60601-1-6:2010,
IEC 62366:2007, ISO EN 10993-1:2009;
EN 61010-1:2001, EN 61010-2-040:05;
EN 13060:2004+A1:2009+A2:2010– Small Steam Sterilizers;
ISO 17665-1:2006– Sterilization of Health Care Products –
moist heat– Requirements for the development, validation
and routine control of a sterilization process for medical
devices.

2.6.2 Quality standards

The company's Quality system is certified according to the following


quality standards:

ISO 9001:2008 – Quality Management


System - Requirements.

ISO 13485:2012 – Quality systems – Medical


devices – Particular requirements for the
application of ISO 9001.

17
3 Detailed Interface of the Autoclave

Front View:

9 3
1 2
7

15

10
14

11 13

12 4 5 6

Fig. 4 - Autoclave Front View

No. Description No. Description


1 Trays Holder 8 Air Filter
2 Tray 9 Fill water to reservoir (from top)
3 Door locker 10 Serial communication port
4 Exhaust Filter 11 Front leg
5 Water Reservoir Drainage 12 Door
6 Printer 13 Chamber
7 Operator Panel 14 Main Switch
15 Optional USB/SD Card slots

18
Rear View

3
2 6
7 4 5
1

Fig. 5 - Autoclave Rear View

No. DESCRIPTION No. DESCRIPTION


Optional-Reverse Osmosis System
1 Rear Cover 5
(RO) Connection*
2 Power Inlet 6 Cut-off switch
3 Rear Leg 7 Autoclave's label
4 Over Flow

*For a machine supplied with a RO system:

No. DESCRIPTION No. DESCRIPTION


4 Drain 5 R.O water inlet

19
4 Safety devices

Thermostat Ty95-HS of Campini Corel Inc.


This safety component interrupts the heating element if the
temperature goes above 170ºC. In order to precede the work, the
user needs to push the reset button.

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

Fig. 6 - Thermostat parameters

Safety Valves of Herose Type 06205.


This safety component releases the pressures above 2.7 BAR.

No. MATERIAL DIN EN ASTM


1 Body CW614N B 283 UNS C38500
2 Valve seal FPM (Viton)
3 Disc CW614N B 283 UNS C38500
4 Stem CW614N B 283 UNS C38500
5 Bonnet CW614N B 283 UNS C38500
6 Spring 1,1200 A 576 Grade 1045
7 Stem guide PTFE B 283 UNS C37700
8 Lifting device CW614N B 283 UNS C38500
9 Closing cap CW507L B 30 UNS C26800

Fig. 7 - Safety valve parameters

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

Fig. 8 - Safety pressure switch

21
4.1 Door Safety System

The door system is automatic and based on a screw -type locking


device. The device consists of a turning screw and a nut, while the
screw is making the connection by means of trapezoidal thread.
The closing device prevents an incidental opening of the door if
there is pressure inside the chamber. To do so, a pressure switch is
assembled inside the unit, which opens a mechanical contact, so
the motor's power supply gets cut if there is any pressure inside the
vessel. The trapezoidal thread is constructed in a way that it is self -
closing, so it cannot release from any types of tearing. The opening
of the door can be done electrically only, in case of power fail, the
user can’t open it without a special opening tool.
The door system includes:
Mechanical locking (a nut which can rotate slightly between at
an angle and a screw)
Self-closing trapezoidal thread
Micro switch which indicates that the door is in closed position
Micro switch which starts the motor run

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 device must be placed on a rigid and leveled surface.


The stand must be able to hold the load of the device and
loaded material (Max 100 kg).The surface size should hold the
device legs (see item 10 in Fig. 4 and item 3 in Fig. 5), namely
min. 50 x 50 cm.

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 .

Keep space around the Autoclave, at least 10 cm at the


back and 15 cm in both sides.

Maintain distance of minimum 40 cm for the top of the


Autoclave to allow the operator to fulfill the Mineral Free
Water Reservoir.

Keep distance of minimum 40 cm for the front of the


Autoclave to let the operator open the door at least 90°
radius.

23
Fig. 9- Placing the device

24
5.2 Power connection

The device must be connected to the Power (see


item 2 in Fig. 5) with a safety approved Power cord, in
accordance with local and regional regulations
and/or rules!

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).

For domestic area use, the sterilizer must be connected to a


separate power line with the Square of the cross section at least
#16AWG and not in touch with a residential zone supply.

Fig. 10- Power Inlet

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!

Disconnect the power supply cord (see item 2 in Fig. 5).

Drain the water from both reservoirs and the vessel.

(See para. 7.3 – Draining Water).

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.

Do not drop this device!

Do not lift the device by the door’s cover!

26
5.4 Setting Atmospheric pressure parameter

In case the autoclave shall be installed in a new


geographic location, with different atmospheric pressure, the
Atmospheric Pressure (ATM) parameter shall be adjusted.
(See para. 9.11 – Modifying system parameters)
Changing the ATMPressure parameter shall be made as follows:

MENU

OPTIONS

TECHNICIAN CODE
CHANGE
PARAMETERS
ATMPressue

In order to adjust the parameter, check what the Atmospheric


pressure in the new location is, and programs the value
accordingly. (Default value is set to 100 in kPa units)

Fig. 11 - Elevation and atmospheric pressure chart

27
6 Preparation before Sterilization

6.1 Loading and unloading the Device

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

The Manufacturer's recommendations concerning the


sterilization of each type of material/item shall be taken into
consideration.

Clean and rinse instruments to dispose any residue, using


appropriate cleaning machines such as an ultrasonic cleaner,
washer, etc. (Follow manufacturer's instructions on the use of
products for cleaning and lubricating instruments after using the
ultrasonic cleaner).
Use materials for inner wraps which are compatible with the
item being packed and with the selected sterilization method
(autoclaveable in 121ºC / 134ºC).
Do not mix between instruments which are not of the same
metal (such as stainless steel, carbon steel, etc.). Make sure to
separate and place on different trays.
Check manufacturer's instructions for the sterilization of each
item.
In case of unwrapped material, place a towel or a paper wrap
on the trays, under the instruments, to prevent corrosion.
Open all instruments and disassemble if possible before
sterilization. Place instruments with ratchets opened and
unlocked or clipped on the first ratchet position.
Empty canisters should be placed upside-down, in order to
prevent accumulation of condensed water.
Use single-use wraps once only and discard after use.
Keep distance between instruments on the tray (Do not
overload the trays and do not pack in layers!).
Allow some distance between trays to permit steam circulation.
Our recommendation is to use indicators in any load to make
sure sterilization is performed.

29
6.2.1 Packs

Place packs upright on trays, side by side.


Packs should not touch the chamber walls.
Pack instrument sets in a manner that prevents damage to
delicate items.
Pack hollowware sets so that all the openings face the same
direction and so that the contents cannot move inside the
pack.
Load packs of folded operating room drapes with layers
vertically, allowing air to be removed from the packs rapidly.
Do not place packs of hollowware and trays of instruments
above textile packs or soft goods in order to avoid wetting
caused by condensation from items above.
Load items packed in flexible packaging materials on the edge
with paper to laminate, or flat with paper surface downwards.

6.2.2 Tubing

When placing in a tray, Make sure that both ends are open,
without sharp bends or twists.

Fig. 12 - Placing instruments on trays (illustration)

30
6.2.3 Wrapped Instruments

Wrapped instruments should be packed in material that


promotes drying such as autoclave bag, autoclave paper,
and muslin towels.
The pouch rack (see picture above) allows the operator to
place pouches on their side, thus increasing the capacity of
the autoclave significantly and promoting better drying of
the instruments. Contact your dealer for details.
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). We recommend to use plastic-plastic or plastic-
paper pouches.

Fig. 13- Wrapped Instruments

31
7 Operating Instructions

7.1 Instruction for Use

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!

(Maximum water amount: approximately 5,5 liters / ~1.45


gallons)
Water filling should be performed only with the Power switch in
“Off” position!
Use distilled water only. Do not use tap water as it may clog
the system!
Usage of the “drained water” of the Drain Water
Tank is strictly prohibited as the exhausted water
may contaminate the sterilization process!

33
Fig. 14- Filling the Water Reservoir

7.3 Draining Water

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!

Fig. 15- Draining the Reservoirs

Connect the supplied silicon tube to the drain connections

34
Fig. 16- Connecting the drain tube

Whenever the reservoir is empty, press the metal lever to


disconnect the drain tube.

Fig. 17- Disconnecting 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).

The printing is made on impact/thermal paper with 24 characters per


line and contains the following information:

Software version (is printed only on Power Off)


Real time
Selected program
Sterilization pressure
Sterilization temperature
Sterilization time
Summary of performed cycle and identification hints.

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

MODEL DCN-191 Series; Data Module


Printing method. Impact dot system
Printing mechanism. EPSON M-160
Data input interfaces. 8 bit parallel Centronics / serial RS232C
Dot composition/line. 144
Printing speed (lines/sec). 1,7
Paper width (mm). 57,5
Printing width (mm). 46
Character dot matrix. 5x7
Characters/line. 24
Operating voltage range. 5VDC +/- 5% 3A peak max.
Dimensions W x D x H (mm). 110 x 43 x 117
Weight (gr). Approx. 300

To ensure a reliable operation of the printer perform the following:


Turn the main switch to the “OFF” position.
Turn the main switch to the “ON” position; press the feed switch
at the same time.
Verify that the printer performs an operation test by printing all
the built-in characters

The following precautions have to be taken ensuring the


proper operation of the printer:

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.

Fig. 18 - Paper loading

39
9 User Interface

9.1 GUI (Graphic User Interface) description

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.

9.2.1 Standby Screen


This screen is automatically displayed after the system is started. This
screen is used to display useful information when the system is on
Standby: Ready status of the machine, Errors, Failures and other
messages are displayed.
The Main screen enables setup of the system: selecting a program,
parameters setup and many other operations that will be described
later in this paragraph.

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.

Not Ready Status

Fig. 19 – System Status Screen

41
9.2.2 Displayed data on Standby screen

Selected Cycle - the autoclave is designed to run several different


cycles. This field represents the current selected cycle and includes
the textual cycle name.

Message – In this line the user will get informative messages, faults
results and instructions.

Clock – Current time of the control system.

Chamber Pressure – Current chamber pressure, stated in kPa units.

Chamber Temp. – Current chamber temperature, stated in °C units.

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

System Message Clock

Cycle Select

Fig. 20 - Standby Screen

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.

Start New Cycle


Pressing this key will start the selected cycle. This key is available when
the device is ready to perform a new process.

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

Pressing the key on the main screen, will show the


‘MENU’ screen:

Fig. 21 - Main Menu Screen

Select the required setup action by pressing the icons shown on

the screen. Pressing the key will go back to the main


screen.

44
9.4.1 Setting the language

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 ‘LANGUAGE’ screen:

Fig. 22 - Language Screen

c. Select the required language by using keys.

d. Press the key to change the system language.

Pressing the key will cancel the ‘LANGUAGE’ screen.

45
9.4.2 Adjusting LCD contrast

a. On the main screen press the key. This will display the
‘MENU’ screen.

b. On the ‘MENU’ screen press the icon. The ‘ENTER


CODE’ screen will be displayed. After typing the code and
submitting, the system will display the ‘OPTIONS’ screen.

c. Browse the menu list using keys and select

‘Screen Contrast’ option. Pressing the key will display


‘SCREEN CONTRAST’ screen:

Fig. 23 - Contrast Screen

d. Use keys to change the contrast.

46
Pressing the key will save the changes.
9.4.3 Setting the system's clock

The Time is represented in HH:MM:SS format.


The Date is represented in DD/MM/YYYY format.

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:

Fig. 24 - Set Clock Screen

c. Touch the required field (Date/ Time).

d. Use the keys to modify the field value.

e. Press the key to save new clock and date values.

47
Pressing the key will exit the ‘SET CLOCK’ screen without
saving.
9.5 Selecting the Cycle

Pressing the Program Icon on the left upper corner of


the main screen will show the ‘SELECT CYCLE’ screen:

Fig. 25 - Select Cycle Screen

This screen displays a list of all available cycles of the machine.

a. Select required cycle using the keys.

b. Press key to select the required cycle.

Pressing the key will cancel the ‘SELECT CYCLE’ screen.


Note: Some of the cycles are protected by code.

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.

The sterility of instruments processed in unwrapped cycles cannot


be maintained if exposed to non-sterile environment.

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.

During flushing, no other cycle can be started! The machine


will display "Flush" on the main screen. When the cycle ends, the
waste water shall be removed from the machine. For machines with
a permanent connection to the drain this will take place
automatically.

49
9.6.1 Cycle no. 1
Flash 134°C /3 min (Warm Up).

Sterilizing unwrapped, solid instruments.


Max solid load: 4 kg.
Load weight / tray < 1 kg.
Sterilization temperature: 134ºC, –0°C +3°C.
Sterilization time: 3 minutes.
Drying time: 1 minute.
Vacuum pulses: 4.
Average cycle time: 40 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

50
9.6.2. Cycle no. 2
Unwrapped 134°C /3 min (Class B)

Sterilizing unwrapped, solid instruments.


Max solid load: 4 kg.
Load weight / tray < 1 kg.
Sterilization temperature: 134ºC, –0°C +3°C.
Sterilization time: 3 minutes.
Drying time: 2 minute.
Vacuum pulses: 4.
Average cycle time: 40 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

51
9.6.3. Cycle no. 3
Wrapped 134°C /3:30 min (Class B)

Sterilizing wrapped instruments.


Max wrapped load: 4 kg.
Load weight / tray < 1 kg.
Sterilization temperature: 134ºC, –0°C +3°C.
Sterilization time: 3,5 minutes.
Drying time: 20 minute.
Vacuum pulses: 4.
Average cycle time: 50 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

52
9.6.4. Cycle no. 4
Prion 134°C /18 min (Class B)

Sterilizing wrapped instruments.


Max wrapped load: 4 kg.
Load weight / tray < 1 kg.
Sterilization temperature: 134ºC, –0°C +3°C.
Sterilization time: 18 minutes.
Drying time: 20 minute.
Vacuum pulses: 4.
Average cycle time: 65 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

53
9.6.5. Cycle no. 6
Porous 121°C /20 min (Class B)

Sterilizing wrapped instruments.


Max hollow load: 2 kg.
Load weight / tray < 0,5 kg.
Sterilization temperature: 121ºC, –0°C +3°C.
Sterilization time: 20 minutes.
Drying time: 20 minute.
Vacuum pulses: 4.
Average cycle time: 65 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

54
9.6.6. Cycle no. 8
Bowie and Dick test 134°C /3:30 min (Hollow load A)

This is a test program, with fixed sterilization parameters


134ºC and 3.5 min. drying time of 1 min. which cannot be
modified by the operator.

Sterilization temperature: 134ºC, –0°C +3°C.


Sterilization time: 3:30 minutes.
Dry Time: 1 minute.
Vacuum pulses: 4.
Average cycle time: 21 minutes.

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.

P1 = Vacuum creation 20 kPa


P2 = Steam penetration 140 kPa
P3 = Sterilization 210 kPa

55
9.6.7. Cycle no. 9
Leak test (Vacuum test).

The vacuum pump is activated until the pressure reaches


a level of at least 20 kPa, all the valves and pump shut down (P1).
The following 5 min. is for the stabilization condition of the chamber
(P2). From now on (P2) along the next 10 min. the allowable
decrease of pressure is 0.13 kPa / min. (or 1.3 kPa for 10 min.)

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.

P2 – P1 < 8.5 kPa


P3 – P2 < 1.3 kPa
t2 = 5 min
t3 =10 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.

9.8. Typing the code


In order to perform protected operations, the system will display the
code screen:

Fig. 26 - Code Screen

To enter the code:


a. Use the NUMBER keys to enter the Operator’s code (“1”).

b. Press key to submit.

In order to clear the code use key.

Pressing the key will cancel the ‘ENTER CODE’ screen.

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

Process Status Process Graph

Fig. 27 - On-process Screen

9.9.1. Displayed data on Process screen

Process Status – Textual indicator which is describes the cycle process.


Process Graph – Process progress. The graph displays Chamber
Pressure as a function of time.
Process Timer – Time since the process had started.
Chamber Temperature - Actual chamber temperature in °C units.
Chamber Pressure - Actual chamber pressure in kPa units.

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.

9.10.2. Status messages:

Fill Water
This message is displayed when the clean water reservoir is empty.
The message disappears after adding water.

Stop Filling Water


Empty the clean water reservoir. This message is displayed if the
clean water reservoir is full.

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.

59
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.

When an error occurs in the system, the ‘Caution’ icon


will be displayed on the main screen.

Error/Failure

Fig. 28 - Error Screen

If an error occurs, or a sterilization process fails, the reason will


be displayed. The system will not respond until the ‘RESET’ key will
be pressed.

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.

09-Ring Sw. Err.


This message is displayed if the Lock Door mechanism fails.

10-Door SW. Err.


This message is displayed if the Door closed switch is in wrong
position.

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.

19-Ring Open Err


This message is displayed if the Door's Ring Unlock process fails.

20-Err Water Pump


This message is displayed when the Water Pump which supplies
water to steam generator fails.

21-Test Fail
This message is displayed when Leak Test cycle or BD-Test cycle
fails.

22-No I2C Com.


This message is displayed when the communication between the
main electrical board and I/O board fails.

23-Coil Temp Cut. (For models with Coil only!)


This message is displayed when the Coil Temperature sensor
fails.

64
9.11. Modifying system parameters

The system allows changing parameters of the selected program.

a. On main screen press the key. This will display the ‘MENU’
screen.

b. On ‘MENU’ screen press the key. The ‘ENTER CODE’


screen will be displayed. After typing the code and submitting, the
system will display the ‘OPTIONS’ screen:

Fig. 29 - Menu Screen

65
c. Browse the menu list using the keys and select
'Change Parameters' option.

d. When 'Change Parameters' option is selected, pressing


key will display the ‘PARAMETERS' screen. Only submitted by user -level,
parameters will be displayed.

Fig. 30 - Parameters Screen

e. Browse the list using the keys to select the


required parameter.

66
f. Press the key to submit the selection. ‘SET PARAMETER’
screen will be displayed:

Fig. 31 - Set Parameters Screen

g. Use key to clear the parameter value field. Use numeric


buttons to type a new value.

h. Press key to submit.

Pressing the key will cancel the ‘CHANGE PARAMETER’


screen.
Note: Parameters are protected by Min/Max values and only allowed
values will be accepted.

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.

10.1. Digital Inputs/Outputs

a. Browse the menu list using the keys and

select 'Digital I/O' option. Pressing the key will display


‘DIGITAL INPUTS & OUTPUTS’ screen:

Fig. 32 - Digital Inputs/Outputs Screen

68
10.2 Analog Inputs

a. On the main screen press the key. This will display the
‘MENU’ screen.

b. On the ‘MENU’ screen press the icon. The ‘ENTER CODE’


screen will be displayed. After typing the code and submitting, the
system will display the ‘OPTIONS’ screen.

c. Browse the menu list using the keys and select

'Analog Inputs' option. Pressing the key will display ‘ANALOG


INPUTS’ screen:

Fig. 33 - Analog Inputs Screen

69
11. Maintenance Instructions

Caution!
Read Safety Instructions (see para. 1.5 - “Safety Instructions”)
first before executing any preventive or corrective actions!

11.1. Preventive and Scheduled Maintenance


The maintenance operations described in this chapter have to be
implemented periodically to keep the device in good condition and
to reduce the breakdown time to a minimum.

The owner of the autoclave is responsible to order an


authorized technician to perform the periodical tests and preventive
maintenance operations, as specified below in this manual.

11.2. Operator’s Tasks:

Corrective and preventive


Daily Weekly Monthly
actions
Clean Door Gasket x
To be performed by the

Clean Chamber x
Clean Chamber Accessories x
Clean Autoclave's Exterior x
operator

Drain Used Water Reservoir x


Clean Mineral Free Water Reservoir x
Clean Mineral Free Water Reservoir's
x
Electrodes
Clean Mineral Free Water Reservoir's
x
Strainer
Clean Chamber Strainer x

70
11.3. Technician’s Tasks:

Corrective and preventive actions 6 Months Yearly


Replace Door Gasket x
Replace Air filter x
Measure Water Quality x
Replace R.O filters (optional) x
Replace Polyphosphate filter
x
(optional)
To be performed by a qualified technician

Clean Both Reservoir's Strainers x


Clean Chamber x
Clean Chamber Strainer x
Clean Steam Generator Electrodes x
Clean Electrical Box x
Clean Valves x
Clean Door Closing Mechanism x
Lubricate Door Closing Mechanism x
Lubricate Door Hinges x
Check Safety Valve x
Check Thermostat x
Check and verify parameters x
Check and fasten Piping and
x
Connections
Check and fasten Bolts and Nuts x
Clean Autoclave's Interior x
Check and verify calibration x

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!

Chamber: Check the interior of the autoclave. If the autoclave is


contaminated it requires cleaning as follows:
Clean and de-scale the chamber with water and soft cloth or sponge
without using a cleaning detergent. You may use diluted lemon acid
(25-50 CC lemon acid in 1 liter of water) as cleaning agent. Rinse out
the chamber with water to avoid stains on the metal.
Do not use steel wool or steel brush as this can damage the
chamber!

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!

Autoclave exterior/covers: Check the exterior of the autoclave. If the


autoclave is contaminated it requires cleaning as follows:
Clean the covering elements with water and soft cloth or sponge,
using a cleaning detergent. You may use alcohol on the plastic
surfaces as cleaning agent.
Do not use steel wool or steel brush as this can damage the
surface of the covers!

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!

1. Open the Autoclave’s door


2. Screw out the chamber filter (rotate counterclockwise)

Fig. 34- Chamber Filter

3. Clean the mesh or replace it if it’s necessary

Fig. 35- Filter and mesh

4. Install the filter mesh back to the chamber (rotate clockwise).

73
11.5. Replacement of consumables:

Bacterial Air Filter


The air filter is used to bring the unit to atmospheric condition at the
end of the cycle. The filter is installed only in pre and post vacuum
autoclaves. The filtration of the air is done by a bacteriological
filter. The filter is mounted on the front side of the autoclave, to
ease access for replacing it.

Unplug the power cord cable from the electrical source


and let the autoclave cool down before start any maintenance
or/and corrective actions.

1. Open the Printer's cover.


2. Unscrew the air filter (see arrow direction).

Fig. 36- Replacing the Air Filter

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.

Unplug the power cord cable from the electrical source


and let the autoclave cool down before start any maintenance
or/and corrective actions.

1. Open the Autoclave’s door


2. Pull off the gasket from the door dome ’s socket

Fig. 37- Replacing the Door Gasket

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).

Verify if there is no blackout in your local electrical system

Display is not responding


Follow procedure in para. 12.1. Display Calibration Procedure

Follow procedure in para. 12.1. Display Calibration Procedure

Door cannot be opened


Verify if "ATM Pressure" parameter is adjusted correctly (see
para. 5.4- Setting Atmospheric pressure parameter).
Verify if the chamber temperature value at the end of a
sterilization cycle is equivalent with the default value (120.0) of
"End Temp" parameter (see para. 9.11- Modifying system
parameters).

Verify if display is responding

System does not step into a ready state


Verify if "mineral free water tank” is filled (see para. 7.2- Filling
the Water Reservoir).

Release used water from “drain tank” (see para. 7.3- Draining
Water).

Verify if R.O system is working properly (optional).

76
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

Sterilization cycle ends with FAIL message


Verify if operation conditions comply with the system
requirements (see para. 2- Operating Conditions).
Verify if “mineral free water tank” is filled completely before
commence sterilization cycle (see para. 7.2- Filling the Water
Reservoir).
Verify if the loaded material complies with the cycle
descriptions (see para. 9.6. Cycles Descriptions).

77
12.1. Display Calibration Procedure

In some cases you may face the following screen:

Fig. 38- System Reset Screen

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:

Fig. 39- Screen Calibration

Firmly press the white square appearing on the screen with a


toothpick or any other object that has a sharp edge but do not harm
the touch screen itself. This process will be carried out twice more,
while the white square will appear in a different position every time.

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

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

80
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

81
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

82
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

83
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

84
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

85
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

86
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

87
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

88
Corrective and Preventive Actions √/X Remarks

Replace Door Gasket □


Replace Air filter □
Measure Water Quality □
Clean Both Reservoirs □
Clean Both Reservoir's Electrodes

Clean Both Reservoir's Strainers □
6 Months Period

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

Check and verify parameters


Check and fasten Piping and
Connections □
Check and fasten Bolts and Nuts □
Clean Autoclave's Interior □
Check and verify calibration □
Service Technician's Name / Signature Implementation Date

89

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