1.manual - ESTERILZADOR TUTTNAUER - MODELO 5596
1.manual - ESTERILZADOR TUTTNAUER - MODELO 5596
1.manual - ESTERILZADOR TUTTNAUER - MODELO 5596
&
MAINTENANCE
MANUAL
BIO HAZARD WASTE REMOVAL AUTOCLAVE
with two Vertical Sliding Doors
and a 27 kW Steam Generator
Model 5596 2VEP
S.N: 13070157, 13070158
1. GENERAL INFORMATION
2. INSTALLATION
3. FUNCTIONAL DESCRIPTION
4.8.7 History---------------------------------------------------------------------------------- 75
5. PRINTER
7.2 For Medical Waste and Infected Instruments and Materials ------------------------ 123
8.2.2 Aborting by the User before the end of the Sterilization ------------------ 134
8.2.3 Aborting by the user after the end of the Sterilization --------------------- 135
8.3 BacSoft Control System Error Messages (Touch Screen) -------------------------- 139
9.5.2 Cleaning and Replacing the Water Level Electrodes ---------------------- 160
9.5.4 Replacing the Generator Side Gauge Glass Indicator Tube ------------- 163
9.9 Working with power ON in Service Area (Autoclaves with sliding doors) -------- 170
Set of Drawings
WARRANTY
We certify that this device is guaranteed to be free from defects in material and
workmanship for one year against faulty components and assembly with the exception of
glassware, lamps and heaters.
The warranty does not include and does not replace routine treatment and preventive
maintenance to be performed according to instructions in the Preventive and Periodical
Maintenance paragraph.
Our obligation is limited to replacing the device or parts, after our examination, if within
one year after the date of shipment if they prove to be defective. This warranty does not
apply to any device that has been subjected to misuse, neglect, accident or improper
installation or application, nor shall it extend to products, which have been repaired or
altered outside the factory without prior authorization from us.
The autoclave should not be used in a manner not described in this manual!
Note:
If there is any difficulty with this instrument, and the solution is not covered in
this manual, contact our representative or us first.
Do not attempt to service this instrument yourself.
Stipulate the model and serial number and describe the difficulty as clearly as possible
so that we may be able to identify the problem and hence provide a prompt solution.
For technical information or service please contact:
Warning!
Only user the autoclave for products approved for sterilization in an autoclave.
Never use the autoclave to sterilize corrosive products or chemicals, such as:
acids, bases and phenols, volatile compounds or solutions such ethanol,
methanol or chloroform nor radioactive substances.
Safety Operating Instructions:
1. NEVER start a new autoclave or a new steam generator, before the safety,
licensing, and authorization department, has approved it for use.
2. All autoclave users must receive training in proper usage from an experienced
employee. Every new employee should undergo a training period under an
experienced employee.
3. A written procedure should be established to ensure safe autoclave operation,
including: Daily safety tests; seal inspection and door hinge inspection; smooth
action of the closing mechanism; chamber cleaning; prevention of clogging;
preservation from corrosion; and finally, what is permitted and what is prohibited
for sterilization and choosing a sterilization program.
4. If there is a steam generator – drain it daily.
5. If there is an air compressor – drain it daily.
6. Before use, check inside the autoclave chamber to ensure that no items have
been left from a previous cycle.
7. Before loading the autoclave, clean the strainer on the chamber floor.
8. Load trays in such a way as to allow steam to move freely among all items.
9. Liquids may be sterilized only with the “liquids” program. The container must be
covered but not sealed. Sealed bottles may only be sterilized using a special
program. The container must be able to withstand the pressure and temperature
of the autoclave.
This autoclave is a high capacity medical waste sterilizer, providing a safe and effective
solution to the sterilization of heavily infected materials from hospitals, clinics medical
research centers, etc., which would otherwise endanger public health and the quality of
the environment.
The effluent sterilization system for medical waste and infected materials ensures an
effective and safe sterilization of the air, aerosols and condensate.
For bio hazard cycles during vacuum operations, for example the exhaust and pre-
vacuum phase, the effluents are evacuated through a high-pressure ejector. The
evacuated effluents pass through a mixing coil. Then, the steam/effluent mixture
continues through a cooler (a heat exchanger with cold water) which cools the effluent
and condensate.
The autoclave operates with saturated steam as the sterilizing agent, and has a
temperature range of up to 137C (279F) and pressure up to 2.3 bar (34 psi).
The autoclave is equipped with a 27 kW built-in steam generator which supplies steam for
the sterilization process.
The autoclave is equipped with two vertical sliding doors. The doors are operated by two
hydro-pneumatic cylinders mounted laterally on both sides of the door. Each cylinder
contains an integrated and separated oil system. The operation of the cylinders is
performed by air pressure and the oil system acts as a speed control system. An
adjustable restrictor controls the flow of oil from one side to the other side on each
cylinder, controlling the speed movement of the door. (For servicing of the unit see the
SERVICING INSTRUCTIONS chapter.)
The autoclave is mounted through a recessed wall. The two doors are located in two
separate rooms, completely isolated.
The front door, on the side of the master control panel is in the preparation area, from
where the autoclave is operated and serves for loading the material into the sterilization
chamber. This area is known as the "dirty side." The rear door is located on the "clean
side" and serves for unloading the sterilized material from the autoclave. This side of
autoclave is equipped with secondary control panel (slave).
The sealing of the chamber is achieved through heat resistant silicone gaskets, located in
grooves around the door openings of the autoclave. The gaskets are pressed against the
doors by compressed air pressure introduced into the grooves behind the gaskets.
The interlocking system of the door is based on the following opening conditions:
A door cannot be opened while the autoclave is in operation.
A door cannot be opened if the chamber is under pressure.
A door cannot be opened if there is liquid in the chamber.
Both doors cannot be opened at the same time. Opening of one door
automatically locks the other.
MAN205-0067093EN Rev. A Jan. 2014
Page 4 of 183 pages
After opening the door on the dirty side, even after closing it and it being
locked and sealed, the door on the clean side can be opened only after
performing a complete sterilization cycle.
If cycle failed, the front door only can be opened.
After test cycle, the front door only can be opened.
The electronic circuitry and software programming of the programmable control system
are designed to operate 9 sterilization programs, In addition, there are two test programs:
Bowie & Dick Test and the Vacuum Leakage Test.
The control system of the sterilizer is based on microcomputer technology, ensuring a
highly reliable and safe operation. The computerized control unit ensures a fully automatic
operation through the entire cycle; hence, after setting the pre-selected parameters and
starting the operation, no further operator intervention is necessary.
The autoclave has an automatic shutdown system. If no buttons or switches are operated
for four hours, it will go into SLEEP MODE and a LED lights up (blinking every second),
indicating that the system is in the SLEEP MODE.
The selected program, the main phases of the cycle and the status of the machine are
controlled and displayed on digital readouts. For process documentation, the important
information concerning operation is printed.
Optionally, a personal computer can be connected to the control system, through
computer connected to the system VIA Ethernet connection. R- PC-R software is used
to view the information.
The autoclave is equipped with five temperature sensors, four pressure transducers, nine
pressure gauges, and safety devices having the following functions:
The temperature sensors:
1. In the drain – (control)
2. In the condensate line(double) – (control, monitoring, and printout)
3. Two in the chamber on flexible hoses (control, monitoring, and printout)
4. In the outlet from the bio-hazard heat exchanger – (control, monitoring, and
printout)
The pressure transducers measure:
1. Chamber pressure – (control, display, and printout)
2. Jacket pressure – (control and monitoring)
3. Door 1 gasket pressure – (control and monitoring)
4. Door 2 gasket pressure – (control and monitoring)
Service area
8. Compressed-air pressure
9. Bio hazard steam
1. The RT112 pressure switches – prevent the opening of the door if there is
pressure in the chamber.
2. The RANCO over pressure switch – controls the over pressure of the steam
generator.
3. Two SMS VM830 end switches – prevent the pressurizing of the chamber and
the door gasket if the door is not closed.
4. Two Safety Bars – prevent the door from trapping any object while closing.
The BacSoft Touch Screen located on the front panel enables the operator to select a
sterilization program, start/stop a cycle, and close or open the door.
The operation and controlling of the autoclave by the technician is through the BacSoft
Keypad and Screen Interface on the rear panel. It enables the technician to select a
sterilization program, start/stop a cycle, close or open the door, set and change a
number of additional parameters and operational modes and perform calibration.
The communication PC-control unit enables the complete control of the autoclave through
the PC, including program selection, starting and stopping a cycle, setting of parameters,
and the real time clock (date and time of the day).
The autoclave is equipped with “Emergency Stop” push-buttons and keys, mounted on
both the front and rear panels. This feature is designed to prevent hazards to humans,
accidents or equipment breakdown in compliance with the European standards EN-285
requirements.
When emergency switch is activated, the key must be used to allow the switch to return
to the operating position.
Do not operate the autoclave in the presence of dangerous gases and vapors.
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and
unauthorized use.
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The operation and controlling of the autoclave is performed through the Touch Screen
Operation Panel Interface. The printer is also located on this side.
An Emergency Stop push-button incorporated with a key lock is installed on the front
panel and is designed to prevent hazards to humans, accidents or equipment
breakdown.
The Service Access Door on the lower part of the front panel enables service under the
chamber.
3
1. Pressure Gauges
2. Touch Screen
3. Printer 4
4 Emergency STOP Switch
5. Chamber door
6. Service Access Panel 5
The operation and controlling of the autoclave is performed through the Bacsoft Keypad
and Screen Interface.
An Emergency Stop push-button incorporated with a key lock is installed on the Back
panel and is designed to prevent hazards to human, accidents or equipment breakdown.
The Back Chamber Door and Service Access Door are accessed from this side.
2
Legend:
1. Pressure Gauges 3
2. Operation Panel Keypad
3. Emergency STOP Switch
4. Chamber Door 4
5. Service Access Panel
1.5 Specifications
Symbol Description
Utility Specification
Warning!
Do not use the autoclave in presence of dangerous gases and vapors.
2.2 Mounting
Place the autoclave on a suitable level surface, leaving adequate space around it for
operation and service requirements.
Level the autoclave before connecting the utilities.
Utilities
Connect the autoclave to the utility supplies as follows:
Air
Connect the air connection of the autoclave to the compressed air supply of the building
by means of a ¼" pipe at 6–8 bar (85–115 psi).
Water
The autoclave is supplied by two water systems:
1. Tap Water
Tap water for the vacuum pump;
Hardness should not exceed 0.7–2 mmol/l See also chapter "Water Quality".
Pressure should be in the range of 2–5 bar (30–70 psi)
Connection to the network by a ½" pipe.
2. Distilled or Mineral Free Water
Distilled or mineral free water for the steam generator.
Connect the distilled or mineral free water reservoir to a distilled or mineral
free water supply source by a ½" pipe.
Pressure should be in the range of 30–70 2–5 bar (psi)
See also the Water Quality paragraph!
Attention
Connection of water systems to the autoclave must be performed through "BACK
FLOW PREVENTION SYSTEM" installation as per EN 1717 regulations and local
regulations.
MAN205-0067093EN Rev. A Jan. 2014
Page 12 of 183 pages
Drain
Connect the following outlets directly to the drain funnel. or connect them
through a drain collector pipe of 4-6” that should be covered. The drain
system should be vented.
General drain outlet by a 1" pipe.
Vacuum pump outlet by a 1" pipe.
Warning!
Only a qualified electrician may perform the electrical connections!
The electrical units should not be placed near water sources.
Connect the power cord to the electric box of the autoclave
Electrical data 3 Ph, 208V/ 60Hz, 80A
Note:
Before operating the vacuum pump, make sure that the pump shaft is free and
you can turn it with a screw driver.
Caution!
If the shaft does not rotate freely, do not connecting live power to the vacuum
pump. Refer to “Releasing the Vacuum Pump Rotor” section for instruction for
Releasing the Vacuum Pump Rotor if it is stuck.
The earth installation at the customer’s site must be built in compliance with the
laws and regulations of the NEC.
7. Move the cursor to user "Technician" and press START/STOP key to get
the SELECT CODE screen.
8. Use all 3 buttons, set code to 0321.
9. Move to SET using START/STOP key.
12. Verify that the USB device is plugged and select menu Import
application from USB.
Files should be copied now and the application should be auto reset.
13. Verify the new Version number printed after the autoclave is turned ON
is the latest Version.
OR
14. Enter OPTION SCREEN again, select VERSION INFORMATION and
verify that the version number that appears on the screen is identical to
the version number that was printed with the date.
The three-phase heating element of the steam generator is driven by DILM32 and
DILM65 contactors and protected by 32A and 63A circuit breakers.Water to the steam
generator is supplied by a one-phase pump, from a water reservoir, which is connected
to a source of distilled or de-mineralized water. The electrical system of the steam
generator is located in a separate electric box.
The water level control system consists of three electrodes connected to the GICAR
2DRLHG controller, which commands the operation of the water pump and servo
solenoid valve to switch OFF the heating current in case of lack of water or low water
level.
Use only distilled or mineral-free water for the operation of the generator!
Caution!
It is strictly forbidden to use soft water; this may results in corrosion of the
generator.
Warnings!
Only a qualified electrician may perform the electrical connections!
The electrical units should not be placed near water sources.
When servicing the generator, disconnect the all electrical power supplies to the
unit. This is done by switching OFF the main power supply switch, or by un-
plugging the electrical power main supply cords.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
The earth installation at the customer’s site must be built in compliance with the
laws and regulations in force, and should meet international electrical safety
standards, and be certified by competent authorities.
Circuit Breaker
(OFF)
Fault Light
On Generator
electric box
Trip Coil
If this happens, do not try to correct the fault yourself, but call for assistance.
Front of Generator
Reference Electrode
Dimensions in mm
The long electrode which is continuously immersed in the water, acts as a reference and
is connected to ground.
The medium electrode (LOW level electrode) controls the water heaters. When it stops
sensing water, the GICAR controller stops the current to the water heaters. When it
senses water, the GICAR controller restores current to the water heaters.
The short electrode (HIGH level electrode), controls the water pump. When it senses
water, the GICAR controller stops the current to the water pump and simultanausly
closes water supply shut off valve. When it stops s ensing water, the GICAR controller
restores the current to the water pump and simultanausly opens water supply shut off
valve.
Electrode Electrode Electrode
Low Low low high
Reference (heater) (water )
1
2 3
44 45 46
S S S S S S
R M m R M m
1 1 1 2 2 2
S E
RL1
GICAR 2DRLH
S E
RL2
L N
VAC
Heater Water
Pump
Q0 CB1 KM1
MAN205-0067093EN Rev. A
L1 T1 L1 T1 L1 T1
R/L1
L2 T2 L2 T2 L2 T2
S/L2
L3 T3 L3 T3 L3 T3
T/L3
TC1
L4 T4
N C1
Heaters 1
R S T
PE/GND
TB1
CB2 KM2
3.
2.
1.
6.
55.
4.
L1 T1 L1 T1
L2 T2 L2 T2
Legend:
L3 T3 L3 T3
TB2 TC2
Heaters 2
To
Control
Panel
HEATERS = 208V/9000W
GND
Jan. 2014
Preparation By: Description Date Rev. No ECO
See page 1
~ VAC
Q0/L4 N
TB6 + -
24VDC
Pressure Temperature Steam
Cut off Level Elec. Low Cut off Pressure Heater 1
CB4
RL1 Air Supply
L T A1 A2 Water Supply Level Elec. High
41 40
38
C1 Pressure Pressure/Float Water Relay
32 33 36 37 RL2
4A
42 43 39 R1
MAN205-0067093EN Rev. A
TC Test Heater 2 NC
34 A1 A2
C2
Water Valve
35
1
Heaters Lamp
2
Trip coil 1
D1 D2
TC1
Trip coil 2
Fault Alarm
1
2 3
44 45 46
Power
S S S S S S
R M m R M m
1 1 1 2 2 2
PS
L N
24VDC L N
VAC
36 33 35
Water
Water Pump Heater Pump
CB3 R1
TB3 TB3
GENERATOR CONTROL ELECTRICAL CASCADE DIAGRAM
L T
M
NO
4A Description: Job No. Scale: Drawing No.
Generator Control Electrical Cascade Diagram
Water Lamp ES1G08-0001-SP
for 2 sets of heater with single phase
Design: Drawing: Quant./Unit: Quant./Job: Cat. No.
Page: 3 Marchel N.
Jan. 2014
3.2 The Piping System
The piping system of the autoclave consists of air-operated valves, which control the
condensate and steam flow in and out of the chamber, operate the vacuum, and the air
inlet valve. The air pulses to the pneumatic valves are transmitted through solenoid pilot
valves, operated at 24VDC.
The valves in the drawing and the manual are numbered according to their function. The
following list includes all the valve numbers that are in use in Tuttnauer.
01. Change-over : steam / electricity
0. 02. Locking door cylinder (front door)
03. Locking door cylinder (Rear door)
11. Feed water – cool jacket
12. Feed water – cool heat exchanger
13. Feed water – cool fast exhaust
14. Feed water – to reservoir
1. FEED WATER
15. feed water – to vacuum pump/ ejector
16. Water outlet
17. Shut
18. Feed water – to air detector
21. Mineral free water - inlet
22. Detergent
MINERAL FREE
2. 23. To spray
WATER
24. Recycling inlet
25. Recycling outlet
31. Air inlet
32. Air inlet - to chamber
33. To splash cooling pipe
34-1. To door 1 seal
COMPRESSED
3. 34-2. To door 2 seal
AIR
38-1. Open door 1
38-2. Open door 2
39-1. Close door 1
39-2. Close door 2
41. Air release N.C.
42. Air release N.O.
4. AIR 43. Filtered air - inlet
44. Air Inlet
45. Air Leak Test
The valve numbers are in accordance with the valve numbering list and piping diagram.
MAN205-0067093EN Rev. A Jan. 2014
Page 26 of 183 pages
PIPING SYSTEM DRAWING
1. The RT112 pressure switch – prevents the opening of the door if there is
pressure in the chamber.
2. Two SMS VM8 End switches – prevent the pressurizing of the chamber and the
door gasket if the door is not closed.
The autoclave is fitted with four pressure transducers for controlling & monitoring:
1. Chamber pressure – (control, display, and printout)
2. Jacket pressure – (control and monitoring)
3. Door 1 gasket pressure – (control and monitoring)
4. Door 2 gasket pressure – (control and monitoring)
The terminals at the connector of the device are 1 (+24V) and 2 (OUT) to the controller
output.
ELECTRIC
CONNECTIONS
Verify th
hat the pum
mp motorr turns in tthe right direction.
d
MAN205-00670
M 093EN Rev. A Jan. 201
14
Page 31 of 183 pages
3.6 The Electrical System
Warning!
When servicing the autoclave, disconnect the all electrical supplies to the unit.
It has to be done by switching OFF the main switch or by un-plugging the main
supply cord.
The electrical system of the autoclave comprises the power circuits including the
commands, switching, and protective components required for the operation of the
electrical equipment of the unit.
The following parts are located in the electrical box, mounted on the upper side of the
autoclave:
Circuit breakers for protection of all power circuits.
One 24VDC Power Supply for powering the solenoid valves.
One 24VDC Power Supply for powering the Control, Touch Screen, Fan, and
Printer.
One 5VDC Power Supply for powering the CUSTOM printer. (If applicable)
Wiring and connection elements.
The earth installation at the customer’s site must be built in compliance with the laws
and regulations of the NEC.
Warning!
Only authorized electricians are allowed to install or attend the electrical system!
Caution!
If the shaft does not rotate freely, do not connecting live power to the vacuum
pump. Refer to “Releasing the Vacuum Pump Rotor” section for instruction for
Releasing the Vacuum Pump Rotor if it is stuck.
The earth installation at the customer’s site must be built in compliance with the
laws and regulations of the NEC.
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and unauthorized
use.
When servicing the autoclave, disconnect the all electrical power supplies to the
unit. This is done by switching OFF the main power supply switch, or by un-
plugging the electrical power main supply cords.
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
Warning!
When servicing the autoclave, disconnect the all electrical supplies to the unit.
It has to be done by switching OFF the main switch or by unplugging the main
supply cord.
3.6.1 BacSoft Controller
The Main Board
Controls and monitors the physical parameters of the process and performs the
operation sequence of the unit according to the selected program.
The main board contains the following elements:
CPU + memory – Backup power input
Memory card expansion
Digital Inputs
The digital inputs are /1 – 9
01: 'Door Closed' (J12:1)
02: ‘Supply Water Indicator’ (J12:2)
03: ‘Supply Distilled Water Indicator’ (J12:3)
04: ‘Emergency Stop’ (J12:4)
05: 'Door 2 Closed' (J12:5)
06: 'Door Unlocked' (J12:6)
07: 'Door 2 Unlocked' (J12:7)
08: Door Locked' (J12:8)
09: Door 2 Locked' (J12:9)
Digital outputs are used to activate the solenoid valves, relays for the pumps.
The command is 24 VDC.
Each output is up to 2A, however all the outputs together will not have a capacity
greater than 65 W.
The Bio Hazard mode prevents dangerous contaminants from entering the drain. The
thermal effluent sterilization system for medical waste and infected materials ensures an
effective and safe sterilization of the air, aerosols, and condensate.
During the exhaust and vacuum operations in the pre-vacuum phase, the effluents are
evacuated through a high-temperature steam operated heat exchanger. The steam is
supplied to the heat exchanger from a separate steam line.
The evacuated effluents, mixed with steam, flow through a heat exchanger heated by
steam. This ensures a sufficient sterilization temperature. This steam/effluent mixture
continues to flow through a cooler, (a second heat exchanger cooled with tap water),
which decreases the effluent and condensate temperatures to an acceptable level.
During the phase when steam enters the chamber, for example through the steam inlet
in the heating and sterilization phase, the chamber outlet is completely closed and the
effluents are sterilized in the chamber at the same temperature and time as the load
itself.
Upon completion of the sterilization phase, the sterilized residual effluents exit the
chamber and are cooled in the cooler, (a second heat exchanger cooled with tap water),
from where the cooled effluents are exhausted to the drain.
When the pressure in the chamber decreases to 115 kPa (17 psi), the vacuum pump
begins operating to ensure the complete evacuation of the residual liquid from the
chamber and piping, and creates a vacuum.
In the normal mode, fast exhaust is performed through the cooler to drain and the slow
exhaust and condensate through the steam-trap and by-pass.
The Bio Hazard cycle will only start when the temperature reaches 134ºC.
The distilled or mineral-free water supply shall be according to the table below:
Physical Characteristics and Maximum acceptable contaminants levels in
water or steam, for steam generator and sterilizers
Contaminants in
Contaminants in
condensate at
water supplied to
steam inlet to
generator
sterilizer
Evaporate residue ≤ 10 mg/l N/A
Silicate (SiO2) ≤ 1 mg/l ≤ 0.1 mg/l
Iron ≤ 0.2mg/l ≤ 0.1mg/l
Cadmium ≤ 0.005 mg/l ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l ≤ 0.05 mg/l
Rest of heavy metals
except iron, cadmium, ≤ 0.1 mg/l ≤ 0.1 mg/l
lead
Chloride (Cl) ≤ 2 mg/l ≤ 0.1 mg/l
Phosphate (P2O5) ≤ 0.5 mg/l ≤ 0.1 mg/l
Conductivity (at 25°C) ≤1 µs/cm ≤ 3 µs/cm
pH value (degree of
5 to 7.5 5 to 7
acidity)
Hardness (Σ ions of
≤ 0.02 mmol/l ≤ 0.02 mmol/l
alkaline earth)
Appearance Colorless, clean, without sediments
Compliance with the above data should be tested in accordance with acknowledged
analytical methods, by an authorized laboratory.
Attention:
The use of water for autoclaves that do not comply with the table above may have
severe impact on the working life of the sterilizer and can invalidate the
manufacturer’s guarantee.
Use Only deionized water, Having a maximum conductance of 1 microSiemen per
cm (1 μS/cm)
Tap Water supply
Maximum hardness value 0.7-2.0 mmol/l
Note:
The use of soft water is strictly forbidden!
Please consult a water specialist!
5
3
Note:
N
Name of th he program
m last used splayed on the scree n and will run
d will be dis
a
again if nott changed.
4.1 D
Descriptio
on and Fun
nctions off the Conttrol Panel
The Con
ntrol Panel is compos
sed of 2 se
ections:
1. Display screen.
s
2. Keypad.
MAN205-00670
M 093EN Rev. A Jan. 201
14
Page 41 of 183 pages
4.1.1 D
Display Sc
creen
The disp
play is a LC
CD panel used to disp
play the cu
urrent statu
us of the auutoclave while
w
using Op
perational Messages
M and Error Messages s.
2
8
3
7
6 4
No. D
Descriptio
on
4 Chambe
er pressure. Displayss the actua
al chamberr pressure..
5 Door Sta
atus. Displlays the do
oors status
s whether open
o or cloosed
The Disp
play Screen
n is compo
osed from ffour majorr sections:
1. Head Line Section.
2. Reporting
g Area.
3. Pre-set Area.
A
4. Informatio
on Area.
MAN205-00670
M 093EN Rev. A Jan. 201
14
Page 42 of 183 pages
1. H
Head Line
e Section
When the e chosen program
p is
s selected, the name and the icon of the pprogram is display
in this se
ection.
After activating the program and
a throug
gh the all cy
ycle, the motion
m iconn is animate
ed.
2. R
Reporting Area
During th
he stages, this area displays
d th e variable data in rea
al time.
Actual Con
ntrol Tempe
erature in
the chambber.
Reference
e Control Te
emperature
Actual Cha
amber pressure
3. P
Pre-set Arrea
This area
a displays the param
meter name
es and valu
ues for cho
osen prograam.
During th
he cycle prrocess the stages an d time (ste
erilization and
a drying)) will be sh
how in
this area
a.
4. Informatio
on Area
em status and door sstatus is displayed in this sectioon.
Informatiion of syste
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4.1.2 Keypad
The keypad consists of three keys as described below:
UP key
This key has the following functions:
In the menu directories:
o This key enables the operator to browse through the
directories.
In the available subdirectories:
o When the cursor is blinking on a number, the UP ▲ key
increases its value.
o When adjusting a parameter and the cursor is blinking on Set
or Exit, the UP ▲ key activates that procedure.
DOWN key
This key has the following functions:
In the menu directories:
o This key enables the operator to browse through the
directories.
In the available subdirectories:
o When the cursor is blinking on a number, the DOWN ▼ key
decreases its value.
o When adjusting a parameter and the cursor is blinking on Set
or Exit the DOWN ▼ key activates that procedure.
START/STOP key
This key has the following functions:
In the main screen:
o Starts the process after the required program is chosen.
o Stops the current process.
o Cancels the ERROR message displayed on the screen.
In the menu directories:
o When the cursor is blinking on a number, the START/STOP
key enables moving to the next position.
o When the cursor is blinking on a selected directory, the
START/STOP key activates that selection.
Message /
Message / Symbol Description Required Action
Symbol Name
Critical settings
have been
If a change of the autoclave
updated, Please Restart the autoclave in order
setting was made, a restart is
restart machine in for changes to be affected.
required.
order for changes
to be updated
The display becomes yellow, a warning sign and the reason of failure will be
displayed.
For example the next two scenarios:
An example for all displayed warnings according to Bowie and Dick Test Failed:
This section contains examples of the range of screens displayed in various operating
scenarios.
The cycle
e ended su
uccessfully on for aborted cycle is displayeed.
y, the reaso
2. P
Pressure Time
T Error Failure o
occurrenc
ce after co
omplete stterilization
n stage
The cycle
e ended su
uccessfully
y, the reaso
on of failurre is displa
ayed.
4.3.3 S
Screens during
d a co
omplete s
successfu
ul cycle – "Cycle
" En
nded"
Note:
OOn the Dissplay, the temperatuure and prressure me
easures arre according to the
cclient reque
est (psi & ºF)
º or (kPa
a &ºC).
1
1. System Ready 2
2. Starting 3. Pullse L
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4. Pulse
eH at
5. Keep Hea 6. H eat
7. Sterilizzation 8
8. Exhaust 9. Dryying
10. End
ding 11. Cycle End
ded
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4.4 D
Descriptio
on of the Control
C Sy
ystem
The follo
owing Blockk Diagram defines th
he hardwarre configuration.
BLOCK
K DIAGRA
AM HARDW
WARE & SOFTWAR
S E COMPO
ONENTS
Main bo
oard
24/12
2 -CPU +meemory- Backup power input I/O Board
24//12 VDC
VDC -MCIMX27LVVOP4A+MC137783VK5
Input
Input CPU- STM332F103R6
6T6
-R.T.C (including Batttery) M41T811SM6E
-24 Digital Ouutputs
COM1
C
-Memory card
c expans sion
(R
RS232) MT46H32M16
6LFBF- -2 Analog outtputs
MAX32 6:B+EPM570
0F256C5+S71W
WS256PD0HF3
3SR0C+ -9 Digital inpuuts
2CSE+
32 K9F1G08ROB-JIB000
Printer - 4 Anaalog Inputs 4-
4
20mAA
Graphic Disp
play 3.5" Keypad Ethernet
Am79C874V
V
D USB Mem
mory
socke
et
ISP1504ABS
4.4.1 A
Applicatio
on System
m Architec
cture
Explana
ation:
1. The digita
al inputs siignal used in all the models
m is similar
s to thhe switch with
w dry
contact.
2. Analog se
ensors use
ed in all the
e models are
a similar for each pparticular
measuremment.
Temperature senso
or PT-100.
Pressure sensor 4--20 mA / 0--400 kPa.
Water ind
dication ele
ectrode ind
dicates watter conducctivity if thee conductiv
vity is
more than 0.2 µ Sieemens, (1/ΩΩ) indicate
es water.
3. Digital An
nalog outpu
uts are dryy contacts that directlly allow opperating low
w
power eleements or indirectly p
powering elements
e via power ddrivers such as
SSR, relaays, contac
ctors etc.
4.5 S
Software Construct
C tion and P
Process De
efinition
4.5.1 G
General
The softw
ware contrrols all the configurat ion options
s and all th
he stages oof the varie
ety of the
processees the who
ole range of o Tuttnaueer autoclavee models.
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Please note! Each model has one configuration and parameters setup. The setup will be
closed after validation. Tuttnauer will validate each model setup, and verify that every
model that produced will get the validation setup.
4.5.2 Machine Set Up
The configuration differences between the models that define different functionality by
the setup are:
Application Type
This step will set up the machine application type.
For machines that have only one panel – choose the 'Local' option.
For machines that have 2 panels – choose the 'Remote' option when
installing the main panel, choose the 'Remote' option when installing the
second panel (proxy).
Model name
This name identifies the particular configuration setup for each model.
Door type
Operates Different types of door- locking device:
Single Manual
Double Manual
Single Motor
Double Motor
Single Hinge
Double Hinge
Single Sliding
Double Sliding
Heating Type
Water heat - By Inlet water into the chamber and heating of the water in the
chamber.
Internal steam generator- inlet steam to the chamber from internal generator
controlled by the control system.
External steam generator - Inlet steam into the chamber. From external
generator that is not controlled by the control system.
Exhaust type
Fast exhaust
Slow exhaust
Cooling Type
None
Water cooling
Air-cooling
J5
BT
P4
J8
T1
J3
P2
J4
P3
The Operating system is Microsoft Windows CE version 6. The code to the Operating
system is supplied by Microsoft. The connection code between the Operating system
and the hardware components (BST – Board Support Package) is supplied by
FreeScale. Minimum suitability for this "Tuttnauer" project is performed in this code.
Development Tools (MAIN card)
The software develop environment is on Microsoft Visual Studio 2005 that includes the
Microsoft Platform Builder for Windows CE 6.0. The specific Tuttnauer system
application is written in C Sharp.net on Microsoft Compact Framework .net.
J1 J4
J12
Digital Inputs
I/O card is an independent card. It checks the card by a method of a continuous scan of
all the ports, saving the data in the memory and transporting this data according to the
request in the communication channel RS-232 to the personally adapted protocol.
At the end of the check process of the digital and analog ports, the communication
channel is checked, in case of receiving a request, the request is checked and if the
request is legitimate it will be taken care of.
The I/O card is controlled by the MAIN card. Only when requests are received from the
MAIN, the requests will be checked and performed.
The I/O card will perform an electrical restart of the systems (I/O card) if it does not
receive requests within 5 seconds. In the next request received from the MAIN, the I/O
card will indicate to the requester of I/O card systems restart.
The "brain" in the I/O card runs on microcontroller type: STM32F103R6T6.
Pulse A Low Define the minimum vacuum/pressure level in 130.0 KPa 5-200
1
Pressure the first pulses group 18.85 psi 0.7-29.0
Pulse A High Define the maximum vacuum/pressure level 180.0 kPa 5-200
1
Pressure in the first pulses group 26.1 psi 0.7-29.0
Pulses B Define the number of pulses in the second
0 # 0-10 1
Count pulses group
Define the additional time that the vacuum
pump will continue to operate or slow/top
Pulse B Stay
exhaust valve will remain open after reaching 2 Sec. 1-100 1
Time
the preset pressure in the second pulses
group
Pulse B Low Define the minimum vacuum/pressure level in 160.0 kPa 5-200
1
Pressure the second pulses group 23.2 psi 0.7-29.0
Pulse B High Define the maximum vacuum/pressure level 180.0 kPa 5-200
1
Pressure in the second pulses group 26.1 psi 0.7-29.9
Dry Time Define the dry time in the program 1 Min. 0-99 1
Dry Air Off Define the pressure in which the air valve will 30 kPa 0-90
1
Pressure be closed during the drying time 4.35 psi 0-13
2. Move the
e cursor to Technician
n and pres
ss START//STOP keyy. The following
screen will
w be displaayed:
3. 0000 is displayed on
o the scre en with the
e cursor blinking on tthe right digit.
4. ase or decrrease the d
To increa digits, pres
ss the UP or
o DOWN kkeys.
5. After changing the code
c to 0 1 move the
32 e cursor to
o Set by preessing the
START/S STOP key.
6. When Se et is blinkin
ng, press th
he UP or DOWN
D keys to enter tthe MAIN MENU of
the autocclave.
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The follo
owing scree
en will be displayed:
d
In order tto exit the ENTER CODE scree he cursor to Exit by ppressing
en move th
START/S STOP Keyy. When Ex xit is blinking press UP
U or DOW WN keys.
7. To browsse through the directo
ories, use the
t UP or DOWN keyys.
8. When thee required directory iss blinking, press the START/ST
TOP key. The
T
required screen
s willl be displayyed.
9. In order to
t exit this screen folllows one of
o the next:
1 Movee the cursoor to Exit w
with the UP N keys and selects it by
P or DOWN
presssing the ST
TART/STO OP key.
2 Presss the UP and DOWN
N keys simu
ultaneously
y.
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4.8.4 Cycle Parameters (Custom 1)
This directory applicable only for custom 1 and custom 2 programs.
Subdirectory Property
1. Purge Time
Pulse B Count
Repeat the action mention in 2: Pulse A Count
a. Sterilization Temperature
See 3: 1Sterilization Temperature
b. Sterilization Time
Repeat the action mention in 3: Sterilization Temperature
c. F0 Mode
Repeat the action mention in 3: Sterilization Temperature
d. Bio Hazard
Repeat the action mention in 3: Sterilization Temperature
Exhaust Mode
Repeat the action mention in 7: Exhaust Mode
Multiple Cycles
Repeat the action mention in 7: End Temperature
When entering the Screen Saver screen, the time will be displayed. The cursor is
blinking on the "minute" digit.
The time is displayed in the form “0000” min.
1. To increase or decrease the digits, press the UP or DOWN keys.
2. After changing the value move the cursor to Set by pressing the
START/STOP.
3. When Set is blinking, press the UP or DOWN keys in order to confirm
changes and return to the previous screen.
4. In order to exit this screen follows one of the next:
a. In order to exit this screen move the cursor to Exit with the
START/STOP key and select it by pressing the UP or DOWN keys.
b. Press the UP and DOWN keys simultaneously.
4.8.7 History
This directory includes three subdirectories:
1. View Old Cycle History
2. Export History to USB
3. Clear History Files
1. Choose the required cycle according to cycle number, date and time
with the UP or DOWN keys.
2. Press the START/STOP key. The printer will print the printout of the
required cycle.
3. In order to exit this screen follows one of the next:
a. Move the cursor to Exit with the UP or DOWN keys and selects it by
pressing the START/STOP key.
b. Press the UP and DOWN keys simultaneously.
2. Export History to USB
This subdirectory enables to Export history to USB device.
1. Insert the USB device into the USB Socket.
2. Move the cursor to Export history to USB.
3. Press the START/STOP key.
4. The following screen will be displayed:
5. Move the cursor to the required item and press START/STOP key.
When entering the SET DATE AND TIME screen, the time and date are displayed. The
cursor is blinking on the "second" digit.
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5. There is an option to stop the test before it is finished by moving the cursor to
Stop and pressing UP or DOWN keys. The test will stop at this point and the
results will displayed on the screen.
6. In order to exit this screen move the cursor to EXIT by pressing START/STOP
key and select it by pressing the UP or DOWN Keys.
5. Print Test
This subdirectory enables the operator to test the printer.
When pressing START/STOP key on the Printer Test item the printer will print out the
following print out:
The following screen will be displayed when entering ADVANCED OPTIONS directory:
When entering the START CYCLE BY CLOCK screen, the time is displayed. The cursor
is blinking on the "minute" digit.
The time is displayed in the form “HH:MM”. The hour range is 24 hours (i.e. from "0" to "24").
2. Enable Cycles
This subdirectory enables to change the temperature units from Celsius to Fahrenheit
and vice versa.
In order to change the temperature units move the cursor to the required item and press
START/STOP key.
In order to exit this subdirectory follow one of the next:
a. Move the cursor to EXIT with the UP or DOWN keys and selects it by
pressing the START/STOP key.
b. Press the UP and DOWN keys simultaneously.
This subdirectory enables to change the MAC address (Media Access Control address)
in order to connect an additional device and connect both of them (or even more)
through remote control.
8. Set Master IP Address
This subdirectory enables to change the IP address (in the front door panel = master) in
order to allowed connection to the autoclave through remote control.
In order to connect more than one machine on the same NET, the IP address of each
machine panel (front and rear) should be unique in the LAN.
9. Set Proxy IP Address
This subdirectory enables to change the machine rear panel (proxy) default IP address.
In order to connect more than one machine on the same NET, the IP address of each
machine panel (front and rear) should be unique in the LAN.
When changing this default IP address on the front panel (master), update value shall be
done on the rear panel (proxy) of the machine.
1. In order to
t enter to the sub dirrectories move
m the cursor by prressing UP
P or
DOWN ke eys to the required ittem and prress STAR RT/STOP kkey.
2. In order to
t exit this screen folllows one of
o the next:
a. Movve the cursor to EXIT
T with the UP
U or DOWWN keys aand selects
s it by
presssing the START/STO
S OP key.
b. Presss the UP and
a DOWN N keys sim
multaneous
sly.
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1. View Current Version Information
In order to view this subdirectory press START/STOP key on the View Current Version
Information item.
This subdirectory enables the operator to see the current version information as
described below:
1. GUI – Graphic user interface – Holds the entire Human Machine interface
including the main application screen and all the configuration screens, which
enable the user to handle the machine.
2. Software – Logic – Holds all the application logic for running the machine.
3. Data – Code – section that handle the entire data storage in the application.
4. Utilities –Utilities – Holds general functionality which is used by the logic
section and the GUI section e.g: converting function to display different
pressure or temperature units, languages types etc.
5. OS – Operational System – Microsoft Windows CE. Version 6.0.
1 2 3 4 5 6
RTCC Error - P
Please Sett Current D
Date And Time.
T
This message is displaayed in ord
der
Sett Current D
Date If th
he problem
m persists, call the
to
o set the da
ate and the
e time.
and
d Time technician.
Doo
or is open This message is displa ayed when n the Clo
ose the dooor to perforrm a new
(Du
uring the cyycle) do
oor is open
n: During t he cycle. cyc
cle.
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Message / Symbol
Failure Description Corrective Action
/ Problem
Periodical check
time exceeded - The periodical maintenance time
Call for service.
Please call for has passed.
service
Supply water error This message is displayed in case of Check and fix the city (tap) water
(digitat input option) a city (tap) water supply malfunction. supply.
Sy
ymbol De
escription Symbol Description
Custom
m T
Textile
Delicatte P
Pasteurization
Wrapped Delicate
e Issothermal
Instrum
ments G
Glasses
Wrapped
V
Vacuum Te
est
Instrum
ments
Pouche
es
Wrapped Pouche
es
Liquids
s
Waste
Big Packages
WarmU
Up
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5. PRINTER
5.1 Printer Output
The autoclave is equipped with a character printer, which prints a detailed history of
each cycle performed. (This can be used for the record or for subsequent consideration.)
The printing is on thermal paper with 24 characters per line and contains the following
information:
Date:
Time:
Ser. Num:
Model:
Version:
Cycle Num:
Cycle Name:
Ster Temp:
Ster Time:
Dry Time:
End Temperature
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 on the next page.
The data is printed from the bottom up, beginning with the date and ending with "Cycle
Ended". For an aborted cycle, "Cycle Failed" and the Error message are printed (refer to
"Displayed Error Messages/Symbols").
Fig. 1
1. Open the printer cover door (3) by pulling it at the left bottom corner (2)
2. Press the OPEN key to open the printer cover as shown (see Fig. 3/1). Handle
the paper cutter carefully not to cut your hand.
3. Place the paper roll making sure it unrolls in the proper direction as shown
(see Fig. .2.2).
4. The paper should roll off the top of the roll.
5. Hold the loose end of the paper with one hand and re-close the cover with the
other hand as shown (see Fig. 3/3) the printer cover is locked.
6. Tear off the exceeding paper using the jagged edge (see Fig. 3/4).
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Fig. 2
7. Close the printer cover door (3) by pressing corner (2), with the tip end of the
paper emerging from the slot (1). See Fig. 2 on previous page.
Notes on treatment of thermal papers
Warning!
Never touch the thermal head immediately after printing because it becomes very
hot. Make sure that the thermal head is cool before setting papers or cleaning the
thermal head.
Machine Configuration:
----------------------
Model Name : '515196-2V28EP'
Serial Number: '13070157'
Bio Hazard Type: 'Térmico'
Cooling Type: 'Ninguno'
Door Type: 'Doble deslizamiento'
Support Touch Screen: 'Yes'
Touch Screen #1 IP: '102.0.0.10'
Touch Screen #2 IP: '102.0.0.11'
Heating Type: 'Generador de vapor externo'
IO Extension Type: 'Ninguno'
Jacket Type: 'Doble pared integrada'
Language: 'Español'
External IP: '0.0.0.0'
Master IP: '102.0.0.1'
Dimension Type: 'Horizontal'
Pressure Units: 'kPa'
Temperature Units: '° C '
Vacuum Type: 'Bomba de anillo de agua'
Machine Variables:
-------------------
Atmosphere Pressure: '100.000'
Cycle count: '0'
Last Service Time: '01/27/2014 00:00:00'
Bio Hazard cycle counter: '0'
Service cycle counter: '0'
Users:
------
01 'Admin' (Admin - 1)
02 'Technician' (Technician - 11)
03 'Y' (Factory - 47)
04 'MOSHE AMOR' (Factory - 59)
05 'S' (Factory - 48)
06 'D' (Factory - 41)
All Inputs/Outputs
MAN205-0067093EN Rev. A Jan. 2014
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------------------
Digital Inputs:
01: 'Puerta cerrada' (J12:1)
02: 'Puerta 2 cerrada' (J12:5)
03: 'Puerta desbloqueada' (J12:6)
04: 'Puerta 2 desbloqueada' (J12:7)
Digital Outputs:
01: 'Zumbador' (J13:2)
02: 'Desbloquear puerta' (J13:4)
03: 'Vapor a Bio' (J13:6)
04: 'Vapor a cubierta' (J13:8)
05: 'Limpiar el filtro' (J13:10)
06: 'Bomba de vacío' (J13:12)
07: 'Escape a Bio' (J13:14)
08: 'Escape principal' (J13:16)
09: 'Válvula de aire atmosférico' (J14:2)
10: 'Escape lento' (J14:6)
11: 'Escape rápido' (J14:8)
12: 'Válvula de vacío' (J14:10)
13: 'Drenaje fresco' (J14:12)
14: 'Vapor a cámara' (J14:14)
15: 'Drenaje de la cubierta' (J15:2)
16: 'Cerrar puerta' (J15:4)
17: 'Abrir puerta' (J15:6)
18: 'Bloquear puerta' (J15:8)
19: 'Cerrar puerta 2' (J15:10)
20: 'Abrir puerta 2' (J15:12)
21: 'Bloquear puerta 2' (J15:14)
22: 'Desbloquear puerta 2' (J15:16)
Temperature Sensors:
01: 'Temperatura de drenaje' (J5) Gain:000.038 Offset-
004.250
02: 'Temperatura de cámara' (J2) Gain:000.038 Offset-
005.975
03: 'Temp filtro riesgo biológico' (J6) Gain:000.038
Offset-002.950
04: 'Temperatura de ref. 1' (J3) Gain:000.037 Offset-
008.469
05: 'Temperatura de ref. 2' (J1) Gain:000.037 Offset-
002.083
Pressure Sensors:
01: 'Presión de la puerta 2' (J7:4) Gain:000.125 Offset-
100.408
02: 'Temperatura de la cámara' (J7:1) Gain:000.125 Offset-
100.495
03: 'Presión de la puerta' (J7:3) Gain:000.125 Offset-
100.433
04: 'Presión de la cubierta' (J7:2) Gain:000.125 Offset-
100.460
Water level Sensors:
01: 'Nivel agua en cámara' (J11:1) Gain:001.000
Offset000.000
System Parameters:
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------------------
CheckSum 27389
01: 'Tiempo de cubierta agotado': 60.0 min
02: 'Puerto de protocolo': 2.0
03: 'Puerto de impresora': 4.0
04: 'Tiempo impresión todo': 180.0 segs
05: 'Tiempo imprimir esterilización': 60.0 segs
06: 'Protector de pantalla': 90.0 min
07: 'Habilitar conexión remota': 1.0
08: 'Contador de ciclos para servicio': 1000.0
09: 'Contador de tiempo para servicio': 360.0 Días
10: 'Filtro de temperatura': 5.0
11: 'Filtro de presión': 5.0
12: 'Filtro del nivel del agua': 5.0
13: 'Código de barras de soporte': 0.0
14: 'Soporte de CFR Parte 11': 0.0
15: 'Desfase con aire atmosférico': 1.0 kPa
16: 'Printer Type': 1.0
17: 'Water Detection Value': 3000.0
18: 'Pressure Calibration High': 300.0 kPa
19: 'Pressure Calibration Low': 25.0 kPa
20: 'Temperature Calibration High': 130.0 ° C
21: 'Temperature Calibration Low': 60.0 ° C
22: 'Contador riesgo biológ a servicio': 500.0
23: 'Temp mínima termo biológica': -10.0 ° C
24: 'Bio Max Temperature Add': 4.0 ° C
25: 'Tiempo de limpieza de filtro': 5.0 segs
26: 'Temperatura de drenaje': 60.0 ° C
27: 'Tiempo de drenaje agotado': 20.0 min
28: 'Open Cool Drain With Vacuum Pump': 1.0
29: 'Tiempo de puerta agotado': 40.0 segs
30: 'Main Panel Door': 2.0
31: 'Agua potable': 1.0
32: 'Fault Dry Time': 1.0 min
33: 'Pump Start Point Gap': 10.0 kPa
34: 'Cycle Print Gap': 14.0
35: 'Open Slow With Main': 1.0
All Cycles Parameters
---------------------
CheckSum 411122
Total Cycles: 11
Enabled Cycles: 11
Disabled Cycles: 0
Tubing
Rinse tubing after cleaning with pyrogen free water. When placing in tray, ensure that
both ends are open, without sharp bends or twists.
Packs
Place packs upright on trays, side by side.
Caution!
It is strictly forbidden to load or unload the loading cart, if the transfer carriage
wheels brakes are not applied.
When loading the materials to be sterilized into the chamber, observe the rules
described in this chapter.
Do not overload the cart or the shelves as this can have adverse effects on the results of
the sterilization and drying. Leave space between the packs or wrapped instruments to
allow complete removal of air pockets in the air removal stage, and for free penetration
of steam in the heating and sterilization stages.
Warnings!
During loading and unloading use safety gloves and glasses in accordance with
local safety regulations and good practice.
It is strictly forbidden to enter the autoclave chamber!
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must lock the system by pressing the
emergency switch and take the key with him to prevent accidents and
unauthorized use.
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
Warning!
Do not o
operate the autoclav
ve in the p
presence of
o dangerous gasess and vapors.
Emergenncy Stop Push-Butt
P ton in coooperative with
w key lo
ock is mo unted on front
panel sw
witches OFF the auttoclave op
peration.
When em mergency y switch is activated
d, the key must be used
u to alllow the sw
witch to
return to
o the operrating position.
Note:
The Touuch Screen n is manufactured ffrom sens sitive mate
erial. Presss gently with
w a
finger orr use a sp
pecial stylu
us. Do nott use a fin
ngernail orr any otheer sharp
impleme ent to opeerate the Touch
T Scre
een.
8.1 O
OPERATIN
NG TOUCH
H SCREEN
N
8.1.1 S
Starting th
he Autocla
ave
Note:
When sttarting the
e autoclav
ve for the ffirst time, adjust and set the ttime and date.
d
Check th
he Touch Screen
S for any Stand by Error or
o Cycle Errror messaages.
If any meessages ap
ppear on th
he Touch S
Screen, take the Corrrective Act
ction recom
mmended
in the “BA
ACSOFT ERROR
E MESSAGES S” section.
The Toucch screen is used to select sterrilization programs. You
Y can onnly select programs
p
from the Touch Scrreen if the autoclave door is op pen. Door open
o is shoown by the
e triangle
symbol
If the con
ntrol is in slleep mode
e, this scree
en appears
s
1. Tap on th
he screen to
t wake up
p the system.
The Auto
oclave Control screen
n appears.
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Program Selector Key
2. To select a sterilization cycle, tap the 'Program Selector Key' (top left-hand
corner of screen).
To find the desired sterilization cycle, tap to go to the next page of the list, and tap
7. Load the autoclave following the steps indicated in the 'Loading' section.
8. For liquid loads, choose the two containers that contain the most liquid, and
insert the two temperature sensors into both, (If applicable).
Warning!
CLOSE
The door will close after you tap .
Keep tools, hands or any other body parts clear of the door while the door is
closing!
CLOSE
9. Tap
The door will close automatically and the Close Door message appears.
OPEN
10. To re-open the door, tap .
12. If the system is ON and there are no alarms (Cycle Status is grey), press
on the Autoclave Control screen to run the selected cycle.
the messa
age will ch
hange to .
Tap
The "Active Alarm Screen"
S ap
ppears
For more
e informatio
on about th
he alarm m s the "BacSoft Conntrol Syste
messages see em Error
Messagees" section
n.
W
Warning!
The loadd has not completed
d a sterilizzation cyc
cle, therefo
ore it is no
ot sterile. Handle
it as con
ntaminatedd load.
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8.1.3 Cycle End
At end of a successful sterilization cycle, a buzzer sounds four times, and
appears. The Cycle Status indicator will be blank and grey.
1. Tap .
OPEN
2. Tap to open the door.
The door will open only if these conditions are fulfilled:
The chamber pressure is below 115 kPa, (2.1 psig).
There is no liquid in the chamber.
The chamber temperature is below the END TEMP parameter.
3. Open the door and remove the sterilized material following the steps indicated
in the ‘Un-loading’ paragraph.
Warnings!
Loading or unloading of material from the chamber can only be done if the door is
completely open and in the lowest position.
It is forbidden to put any part of the body inside the chamber whilst the door is
closing.
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must shut the system by actuating
the emergency switch and withdraw the key from the system, keeping the key on
him, to prevent accidents and injuries.
Do not operate the autoclave in the presence of dangerous gases and vapors.
Verify that the pressure in the chamber is atmospheric pressure. Do not attempt
to open the door if the pressure in the chamber is above atmospheric pressure.
Note:
For a two door autoclave, after a failed cycle, the front door only can be opened.
DO NOT ATTEMPT TO OPEN THE DOOR UNTIL NOTIFIED THAT THE ABORT
SEQUENCE IS COMPLETE. IF THE CONTROLLER DOES NOT INDICATE THAT THE
SEQUENCE IS COMPLETE, DO NOT ATTEMPT TO OPEN THE DOOR. CONTACT
YOUR TUTTNAUER TRAINED AND CERTIFIED AUTOCLAVE TECHNICIAN.
Warning!
The load has not completed a sterilization cycle, therefore it is not sterile. Handle
it as contaminated load.
Warning!
Do not operate the autoclave in the presence of dangerous gases and vapors.
Emergency Stop Push-Button in cooperative with key lock is mounted on front
panel switches OFF the autoclave operation.
When emergency switch is activated, the key must be used to allow the switch to
return to the operating position.
8.2.1 Starting the Autoclave
Note:
When starting the autoclave for the first time, adjust and set the time and date.
Check the BacSoft screen for any BACSOFT ERROR MESSAGES.
If any messages appear on the BacSoft screen, take the Corrective Action
recommended in the “BACSOFT ERROR MESSAGES” section
The BacSoft Keypad is used to select sterilization programs. You can only select
programs from the BacSoft Keypad if the autoclave door is open. Door open is shown by
2
8
3
7
6 4
No. D
Descriptio
on
4 Chambe
er pressure. Displayss the actua
al chamberr pressure..
5 Door Sta
atus. Displlays the do
oors status
s whether open
o or cloosed
The name
e of the program app
pears in the
e top of the
e BacSoft home scre
een.
Note
e:
You cann
not select a new prog
gram while a program
m is runningg.
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Make sure that you selected the correct cycle.
4. Load the autoclave following the steps indicated in the “Loading” paragraph.
5. For liquid loads, choose the two containers that contain the most liquid, and
insert the two temperature sensors into both, (If applicable).
Warning!
6. Click
The screens and the messages changes to show progress of the cycle.
Warning!
If the load has not completed a sterilization cycle, it is not sterile. Handle it as
contaminated load.
8.2.3 Aborting by the user after the end of the Sterilization
If the cycle is stopped after the end of the Sterilization, the load is sterile.
The user can stop/abort the program while the autoclave is operating.
The white caution screen is displayed with the reason for the failure message.
1. Click
The messa
age appearrs.
The follow
wing scree
en is displa
ayed while the door is
s opening
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Warning!
Warnings!
Loading or un-loading of material from the chamber can only be done if the door
is completely open and in the lowest position.
It is forbidden to put any part of the body inside the chamber whilst the door is
closing.
If, for any reason (for cleaning, maintenance or if something falls down), it is
necessary to enter the chamber, the person must shut the system by actuating
the emergency switch and withdraw the key from the system, keeping the key on
him, to prevent accidents and injuries.
Do not operate the autoclave in the presence of dangerous gases and vapors.
Verify that the pressure in the chamber is atmospheric pressure. Do not attempt
to open the door if the pressure in the chamber is above atmospheric pressure.
Note:
For a two door autoclave, after a failed cycle, the front door only can be opened.
Warning!
If the load has not completed a sterilization cycle, it is not sterile. Handle it as
contaminated load.
Warnings!
These service instructions are for the use of qualified personnel only! To avoid
electric shocks, do not perform any servicing other than that specified in the
operating instructions unless you are qualified to do so. Refer all servicing to
qualified service personnel.
When servicing the autoclave, and/or opening any service panel, disconnect the
all electrical power supplies to the unit. This is done by switching OFF the main
power supply switch, or by un-plugging the main electrical power supply cords.
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
Caution!
Do not use steel wool or steel brush as this can damage
the chamber!
2. Place several drops of oil on all the door spindles and pins (if
User
Weekly applicable).
3. Drain the generator (if applicable) as follows:
a. Switch OFF the power.
b. Wait until the pressure decreases to 0.5 bar (watch the
pressure gauge).
c. Open the drainage manual valve for a few seconds till the
glass tube becomes empty, and then close the valve.
d. Drain the water level tube by opening the tube’s valve
located at the bottom elbow connecting the tube to the
vessel.
4. At the end of the week, or if the autoclave will stand for a
prolonged period, clean the chamber when it is cold, and
leave the door open.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
Attention!
After every repair or dismantling the enclosure, the autoclave should pass two
electrical safety test by the qualified Service Engineer. The following shall be
performed:
After performing these tests, the Service Engineer should complete and sign the
Work Order and the Log Book.
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
The technician must follow the instructions in the SERVICE INSTRUCTIONS,
“Working with power ON in Service Area” Section.
1. Control unit not initialize. 1.1 The control circuit 1.1 Check and switch on
No display and lights on the breaker switched off. the circuit breaker.
front panel.
1.2 The power switches 1.2 Replace the defective
on the front panels of switch.
the autoclave or on the
steam generator are
defective.
2. Steam generator does not 2.1 Water pump defective 2.1 Repair or replace
operate. or blocked. pump. Replace motor.
1. Steam 1.1 No power from the building 1.1 Check the reason for no
generator does source. power supply from the
not start. building.
1.2 Generator Circuit breakers
1.2 Turn ON the circuit
(1ph & 3ph) are OFF.
breakers (1ph & 3ph)
1.3 Trip coil is activated (no power
1.3 Check the interlocks status.
feed)
1.4 Water level in the generator is 1.4 No water inlet, See Section
low. No.2 below.
2. Water is not 2.1 The water pump is defective or 2.1 Check, repair or replace
filled into the blocked. the pump.
generator. 2.2 The water inlet solenoid valve 2.2 Check power on solenoid
does not open. contacts or, repair/replace
the valve.
2.3 Check for short circuits, or
2.3 The circuit breaker in the
circuit breaker is defective.
water pump motor circuit trips
Replace the circuit breaker,
OFF.
or fix short circuit.
2.4 Check wires connectivity
2.4 The GICAR water level between the electrodes
controller or the electrodes is and the water level
defective. controller or replace the
defective electrode or
electronic board.
2.5 The circuit Relay is defective. 2.5 Replace the circuit Relay.
2.6 The circuit breaker of the 2.6 Check and switch ON the
control circuit is OFF or circuit breaker of the
defective. control circuit.
3. Steam pressure 3.1 The pressure switch is faulty 3.1 Check the pressure
does not or incorrectly set. switch, set it correctly or
increase or replace if faulty.
increases too 3.2 The circuit breakers in the 3.2 Check the cause and
slowly. heater circuits are switched switch ON the circuit
OFF. breakers.
3.3 The water level control system 3.3 Check and replace the
is defective. defective electrode or
GICAR controller.
3.4 The heater contactor is 3.4 Check and replace the
defective. heater contactor.
3.5 Heaters are burned out. 3.5 Replace the damaged
heaters; check if the
water level is sufficient.
3.6 There is a leakage in the 3.6 Tighten or replace piping
safety relief valve caused by connections, fix or
loose or defective fittings, or replace the safety valve.
by blockage.
4. Steam pressure 4.1 The pressure switch is faulty 4.1 Set the pressure switch
goes up beyond or set incorrectly. correctly or replace if
the set control faulty.
point. 4.2 The heater contactor is stuck. 4.2 Replace the heater
contactor.
5. The safety valve 5.1 The steam pressure is higher 5.1 Check cause and
blows. than the working pressure. remedy it, See section 4
above)
5.2 The safety valve is defective. 5.2 Check and replace the
safety valve.
Adjustin
ng the Pre
essure Switches
gulated, however,
The presssure swittches are factory reg h n order to adjust the steam
in
pressure
e, follow thiis procedure:
Operatin
ng Control Pressure
e Switch
To set the
e pressure in which tthe heating
g elements turn OFF,, turn the bronze
b
color knob. Turn it clockwise
c tto decrease pressure
e and counnterclockwise to
increase the
t pressu ure.
To set the
e pressure in which tthe generator restarts
s (i.e. the ppressure differential
between the
t turn-offf and the tturn-on pre
essures) turn the blacck color preessure
switch knob. Turn itt clockwise
e to decrea
ase pressurre and couunterclockw wise to
increase the
t pressu ure.
The p
pressure sw
witch will be
b set to an
n output stteam press
sure of 3.5 -4 bar.
Limiting
g Control Pressure
P Switch
S
To set the
e cut-off prressure, tu rn the bron
nze-colored pressuree switch knnob. Turn itt
clockwisee to decreaase pressu re and cou unter-clock
kwise to inccrease the pressure.
The p
pressure sw
witch will be
b set to a cut-off pre
essure of 5 bar.
Resett
lever
Turning off
pressure
e
Cut-offf
Differentia
al
pressurre
pressure
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3 pages
9.5.2 Cleaning and Replacing the Water Level Electrodes
The three electrodes of the water level control system are mounted on the top of the
steam generator.
Cleaning the Water Level Electrodes
1. Turn OFF the electric power and discharge the steam pressure from the
autoclave and the steam generator.
2. Disconnect the wires from the electrode connections.
Note:
Mark the wires before removing them. It is essential to return the correct wire to
its corresponding electrode!
3. Remove the electrode.
4. Clean the electrode.
5. Ensure that the tip of the electrode is bare exposed metal for 20mm from the end.
Front of Generator
Reference Electrode
Dimensions in mm
Front of Generator
Reference Electrode
Dimensions in mm
Heaters
Warning!
Do not exceed the recommended pressure of the gauge glass.
Caution!
Do not subject gauge glass to bending or torsional stresses.
Note:
On each side of the glass tube, there are stainless steel balls that act as a safety
device by preventing the escape of steam and boiling water if the glass is
broken. Before replacing the glass water tube, switch OFF the electrical power
and release steam pressure from the vessel.
1. Drain the water.
2. Remove the protective cover from the new glass tube.
3. Loosen the two nuts on both sides of the glass tube. Slip the upper one down,
and then take off the tube.
4. Replace the tube with a new one.
5. Do not allow glass to touch any metal parts.
6. Replace the two packing nuts and hand tighten, then tighten ½ turn more by
wrench.
Glass Tube
Warning
To prevent electrical shock, disconnect power before initiating any work. In the
case of pump failure, the pump housing and/or the pumped fluid may carry high
voltage to components normally considered safe
Release pressure on the outlet side of the pump before doing any maintenance
work.
Check the pump for any sign of damage. If the pump has any indication of failure,
contact Tuttnauer for a complete motor assembly. Proceed as follows to replace the
pump.
3 6
2 7
The vacuum pump could get locked after a prolonged idle period.
Further described, is the procedure to follow in order to unlock and restore the normal
operation of the pump.
1. When the pump is operated for the first time, check if it works normally.
If not, stop the electric current immediately.
2. Do not open the pump and by no means, try to free the rotor shaft, by
forcibly rotating the impeller, this can provoke an irreversible damage to
the pump.
3. Further described is the way to proceed, for restoring the normal
operation of the pump.
4. Carefully remove the fan cover from the vacuum pump.
5. By means of a screwdriver, rotate in clockwise direction the shaft of the
pump on which the cooling fan of the motor is mounted.
The shaft will be unlocked and the pump is ready for operation.
6. If it did not help, unscrew the pipes connected to the pump and pour in
a quantity of 200ml. of edible vinegar available at any grocery shop.
Leave the pump in this situation for ½ – 1 hour.
7. By means of a screwdriver, rotate the shaft of the pump on which the
cooling fan of the motor is mounted in a clockwise direction. The shaft
will be unlocked and the pump is ready for operation.
8. Replace the fan cover when done and tighten the screws.
3. 0000 is displayed on the screen with the cursor blinking on the right digit.
Increase the cursor to 0002 move the cursor to "Set" and press UP or DOWN keys,
5. M
Move the cu
ursor to "An
nalog inpu ts calibratiion" and prress STAR
RT/STOP key.
k
6. Move the cuursor to "Chhamber Te emperature e" with the UP andd DOWN keys.
W
When it is blinking, sellect it by prressing the
e START/S STOP key..
MAN205-00670
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14
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3 pages
This is a typical callibration sc
creen.
This scre
een presen
nts the currrent read te
emperaturre on scree
en top rightt.
2. Move the cursor to "Calibrate analog input" with the UP and DOWN keys,
and then when it is blinking select it with the START/STOP key.
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3 pages
9.9 Working with power ON in Service Area (Autoclaves with sliding doors)
Warning!
Warning!
Before testing the safety valve, wear heat resistant safety gloves and keep all
body parts away from the steam flow.
Attention!
Make sure that the test is performed while the door is closed.
Lift the lever to clear the Safety valve seat.
1.1 Set the pressure of the working pressure switch and cut off pressure switch to
6 bar.
1.2 Operate the generator and verify that the pressure increases by checking the
generator pressure gauge.
1.3 Verify that the safety valve blows in the range of 75 – 80 psi. (5–5.5 bar).
1.4 If the safety valve did not blow at the pre-set pressure stop the operation of
the generator, decrease the pressure to atmospheric pressure and replace
the safety valve with a new one.
1.5 If the safety valve was replaced, repeat step 1.1—1.4 to test the new one.
1.6 Re-adjust the pressure of the working pressure switch to 3.5—4 bar, and then
Re-adjust the cut off pressure switch to 5 bar.
2.2 Turn the adjustment knob one turn in the pressure increase direction.
2.3 On the solenoid valve battery, open manually valve 91. This is done by
turning the adjustment screw until the screw's slot is vertical.
2.4 Operate the autoclave and verify that the pressure increases.
2.5 Verify that the safety valve blows in the range of 40 – 44 psi (2.8 –3.0 bar).
2.7 If the safety valve was replaced, repeat step 2.1—2.5 to test the new one.
2.9 Readjust the pressure regulator to the original position. Use the marking as
mentioned above in Step 2.1
Warning!
It is strictly forbidden for any person to enter the service area behind the service
access panels, except the trained technician.
If, for any reason it is necessary to open the service access panel, the person
must shut the system by pressing the emergency switch, withdrawing the key and
keeping the key on him, to prevent accidents and injuries.
Warning!
Before replacing the gasket, verify that the autoclave is cold; that the power is
turned OFF; and, that there is no pressure in the jacket and in the chamber.
1. Remove the damaged gasket.
2. Check the new gasket and verify that it is not damaged.
3. Verify that the gasket groove is clean.
4. Begin inserting the gasket into the groove by pressing it into the middle of the
upper part of the groove. Verify that the point of the glued end (1) (the part of
the silicon tube where the two ends meet) is placed in the middle of the upper
groove.
5. Insert the gasket into the groove in the middle of each side (2) (top, bottom, left
and right) and in each corner.
6. Continue to insert the gasket into the groove in the middle of each loose part,
i.e. between two inserted points (3) & (4).
The final adjustment of the gasket will be done automatically at the first "closing door."
2
Legend
6
MAN205-0067093EN Rev. A Jan. 2014
Page 174 of 183 pages
10. SPARE PARTS LIST
Part No. Description
PNE195-0024 Stop Valve + Check Valve ¼", Cylinder ISO 50 (oil reservoir)
Safety Valve, ASME V/PED, ¾" MPT x 1" FPT, Brass Body,
R SVL029-0077
Brass Seat, 5 bar (75 psi), Open Lever
Safety Valve, ASME, ¼" NPT x Disch. H., Brass Body, Soft
R SVL029-0090
Seat, 2.8 bar (40 psi), Plain Cap
VLV170-0035 Valve, Manual, Ball, ½", F*F, 4640 Stopper, Rex Int.
VLV170-0036 Valve, Manual, Ball, ¾", F*F, 4640 Stopper, Rex Int.
VLV170-1036 Valve, ball, pneumatic actuated, 2/2 way, St. St., NC, ½",
Note:
R– Recommended spare parts list (to be maintained by the operator)
Legend:
psia ─ absolute pressure in psi
Psig ─ gauge pressure in psi
kPa ─ absolute pressure in kilo-Pascal
InHg ─ pressure (vacuum) in inch-Mercury