Tuttnauer 55120 1REP User manual

OPERATOR
MANUAL
Pre-vacuum Steam Heated Autoclave
with one Manual Hinged Door
and a 27 KW Steam Generator
Model 55120 1REP
S.N.: 1306099; 14020678
Cat. No. MAN205-0097044ENO Rev. A April 2014
Tuttnauer. Ltd., Har Tuv Industrial Zone, B P.O. Box 170, Beit Shemesh, 99000, Israel,
Tel:[phone] Fax:[phone]
Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR Breda, P.O. Box 7191, 4800 GD Breda, Netherlands.
+31/76-5423510, Fax: [phone]

Web site: http//www.tuttnauer.com

Cat. No. MAN205-0097044ENO Rev. A Apr. 2014
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Table of Contents
Safety Instructions --------------------------------------------------------------------------------- 1
Symbol Description-------------------------------------------------------------------------------- 3
1. GENERAL DESCRIPTION
1.1 Introduction ------------------------------------------------------------------------------------- 4
1.2 Front Panel-------------------------------------------------------------------------------------- 6
2. PRINTER---------------------------------------------------------------------------------------- 8
2.1 Printer Output ---------------------------------------------------------------------------------- 7
2.2 Printer Handling-------------------------------------------------------------------------------- 9
3. STERILIZATION PROGRAMS------------------------------------------------------------ 12
4. PREPARATION BEFORE STERILIZATION------------------------------------------- 13
4.1 Loading ------------------------------------------------------------------------------------------ 14
4.2 Un-loading--------------------------------------------------------------------------------------- 15
5. OPERATING INSTRUCTIONS (TOUCH SCREEN) --------------------------------- 17
5.1 Before Starting the Autoclave -------------------------------------------------------------- 17
5.2 Malfunctions ------------------------------------------------------------------------------------ 20
5.3 Cycle End --------------------------------------------------------------------------------------- 21
5.4 Aborting a Cycle ------------------------------------------------------------------------------- 22
6. Maintenance of Autoclave ---------------------------------------------------------------- 23
6.1 Preventive and Periodical Maintenance ------------------------------------------------- 23
7. BacSoft Error Messages------------------------------------------------------------------- 24
7.1 BacSoft Touch Screen Stand by Error Messages (Touch Screen) --------------- 24
7.2 BacSoft Touch Screen Cycle Error Messages (Touch Screen)-------------------- 26

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Safety Instructions
The autoclave has unique characteristics. Please read and understand the operation
instructions provided by the manufacturer before the first operation of the autoclave.
The following issues may require clarification: The operation of the autoclave; the
door safety mechanism; the door closing mechanism; the dangers involved in
circumventing safety means; and finally, the selection of an appropriate sterilization
program.
Make sure that you know the placement of the main power switch, the position of the
water cut-off valve, and where the steam and compressed air disconnection valves
are located.
Autoclave maintenance is crucial for the correct and efficient function of the device.
We recommend a daily B&D test and the weekly spore test as part of the preventive
maintenance plan, along with the annual validation of the sterilization processes that
ensures appropriate temperature dispersion within the chamber.
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.
10. When sterilizing plastic materials, make sure that the item can withstand
sterilization temperature. Plastic that melts in the chamber is liable to cause a
great deal of damage.

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11. Individual glass bottles may be placed within an appropriate container that will
be placed on a tray. Never place glass bottles on the floor of the autoclave.
Never fill more than ⅔of the bottle volume.
12. On closing the autoclave door, make sure that it is properly locked before
starting a cycle.
13. Verify once again that you have chosen the appropriate sterilization program.
14. Before withdrawing trays, wear heat resistant gloves.
15. Before opening the door, verify that there is no pressure in the chamber
(chamber pressure gauge is located on the autoclave's front panel).
16. Open the door slowly to allow steam to escape and wait 5 minutes before you
remove the load. When sterilizing liquids, wait 10 minutes, or until the
temperature reaches 5°C above atmospheric temperature.
17. Once a month, ensure that the safety valves are operating.
18. Once annually, or more frequently, effective tests must be performed, i.e.,
calibration and validation.
19. Check the condition of assemblies on a regular basis. Make sure there are no
leaks, breaks, blockages, whistles or strange noises.
20. Perform maintenance operations as instructed.
21. Notify the person in charge immediately of any deviation or risk of proper
function of the device.
22. It is strictly forbidden for any person to enter the autoclave’s chamber. If, for any
reason (for cleaning, maintenance or if something falls down), it is necessary to
enter the chamber, the person must lock and take the key out of the system,
keeping the key on him, to prevent accidents and injuries.
Instructions for Contaminated Waste
1. Verify that the contaminated waste at the sterilization station is packed in the
correct bags/containers.
2. Verify that there are no leaks and that the package is correctly marked.
3. Large containers with a narrow spout may “behave” like a sealed bottle.
4. It is preferable to sterilize solutions in small containers rather than in differently-
sized containers or in large containers.
5. It is recommended not to stand in front of the door when it opens, because
steam may be discharged when the door is opened.
6. It is recommended to support sterilization bags at the bottom – especially when
they are hot.
Attention:
IF THE UNIT IS USED IN MANNER NOT SPECIFIED BY THE MANUFACTURER,
THE PROTECTION PROVIDED BY THE EQUIPMENT MAY BE IMPAIRED.
KEEP THE DOOR CLOSED DURING THE DAY OR SHIFT. WHEN THE AUTOCLAVE
IS NOT OPERATING, AT NIGHT OR ON THE WEEKEND, LEAVE THE DOOR OPEN.

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Symbol Description
Symbol Description
Caution! Consult accompanying documents
Caution! Hot surface.
Caution! Hot steam.
Protective earth (Ground)

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1. GENERAL DESCRIPTION
1.1 Introduction
This autoclave is a sterilizer designed to cover a large field of applications for hospitals
and medical centers as well as pharmaceutical and biotechnological industries.
The autoclave operates with saturated steam as the sterilizing agent, and has a
temperature range of up to 137C (279ºF) and pressure up to 2.3 bar (34 psi).
The autoclave is equipped with a 27kW built-in steam generator.
The autoclave is equipped with an “Emergency Stop” push-button and key lock,
mounted on the front panel. This feature is designed to prevent hazards to humans,
accidents due to equipment breakdown in compliance with the European standards EN-
285 requirements.
When an emergency switch is activated, the key must be used to allow the switch to
return to the operating position.
The autoclave is equipped with one manual hinged door, closed and opened manually.
The door is locked by rotating a wheel located on the front of the door. The locking
mechanism incorporates a safety lock which locks the door in the closed position,
preventing the door locking mechanism from opening. The door will only open if
conditions in the chamber allow the locking mechanism to unlock the door.
The sealing of the chamber is achieved through a heat resistant silicone gasket, located
in a groove around the door opening of the autoclave.
The interlock system of the door is based on the following opening conditions:
The door cannot be opened while the autoclave is in operation.
The door cannot be opened if the chamber is under pressure.
The door cannot be opened if there is liquid sensed on the chamber floor.
The door cannot be opened at the end of the cycle if the chamber temperature
is higher than the preset final temperature.
The electronic circuitry and software programming of the programmable control system
are designed to operate 6 sterilization programs. In addition there are two test programs:
Bowie & Dick Test and the 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 there are no operations for four
hours, the autoclave goes into 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.
The touch screen located on the front panel enables the operator to select a sterilization
program, and start/stop a cycle.

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Note:
The Touch Screen is manufactured from sensitive material. Press gently with a
finger or use a special stylus. Do not use a fingernail or any other sharp
implement to operate the Touch Screen.
Caution!
Do not operate the autoclave in the presence of dangerous gases and vapors.
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.
Warnings!
Do not operate the autoclave in the presence of dangerous gases and vapors.
It is strictly forbidden to enter the autoclave chamber!
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.

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1.2 Front Panel
The operation and controlling of the autoclave is performed through the Touch Screen
Interface.
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.
6
2
1
Legend:
1. Pressure Gauges
2. Touch Screen
3. Printer
4. Chamber Door
5. Emergency STOP Switch
6. Service Access Panel
4
5
3

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2. PRINTER
2.1 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").
For an example of a typical printout, see next page.

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2.2 Printer Handling
Maintenance
Wipe off any dirt on the printer surface with a dry soft cloth with a weak neutral
detergent. After that, wipe the printer with a dry cloth.
Setting Paper
Printer model PLUS II front view
1. Paper mouth
2. STATUS Led
3. OPEN key (for paper roll compartment opening)
4. FEED key
5. Paper roll compartment
6. Paper end sensor
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. 3/2).
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).
Fi
g
. 1

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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
Store the papers in a dry, cool and dark place.
Do not rub the papers with hard substance.
Keep the papers away from organic solvent.

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Cautions!
Never disassemble the printer. Failure to follow this instruction may cause
overheating or burning of the printer or the AC adapter. Or an electric shock,
which may lead to fires or accidents.
Never use the printer in a place of extreme humidity or any place where it can
possibly be splashed by any liquids. If any liquids get into the printer, it could
lead to fire, electric shock, or other serious accidents.
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.
Power OFF the printer in any of the following cases:
The printer does not recover from an error.
Smoke, strange noise or smells erupt from the printer.
A piece of metal or any liquid touches the internal parts or slot of the printer.

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3. STERILIZATION PROGRAMS
Cycle Id: Instruments
Sterilization temperature 134°C
Sterilization time 3 minutes
Dry time 1 minute
Cycle Id: WrappedInstruments
Sterilization temperature 134°C
Sterilization time 7 minutes
Dry time 20 minutes
Cycle Id: Pouches
Sterilization temperature 121°C
Sterilization time 15 minutes
Dry time 1 minute
Cycle Id: WrappedPouches
Sterilization temperature 121°C
Sterilization time 20 minutes
Dry time 30 minutes
Cycle Id: WrappedDelicate
Sterilization temperature 121°C
Sterilization time 15 minutes
Dry time 20 minutes
Cycle Id: BigPackages
Sterilization temperature 134°C
Sterilization time 7 minutes
Dry time 30 minutes
Cycle Id: VacuumTest
Cycle Id: BDTest
Sterilization temperature 134°C
Sterilization time 3.5 minutes
Dry time 2 minutes

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4. PREPARATION BEFORE STERILIZATION
Warning!
During loading and unloading use safety gloves and glasses in accordance with
local safety regulations and good practice.
Instruments to be sterilized must be clean, free from any residual matter, such as debris,
blood, pads or any other material. Such substances may cause damage to the contents
being sterilized and to the sterilizer, and prevent sterilization.
1. Wash instruments immediately after use, to dispose of any residue.
Follow manufacturer's instructions on the use of instruments/washing etc., for cleaning
and lubricating. Before placing an instrument into the sterilizer tray, make sure that
instruments composed of different material-types (stainless steel, carbon steel, etc.) are
separated and placed in different trays.
Note:
Check manufacturer instructions for sterilization of each item.
In General
1. If carbon steel instruments are used with stainless steel trays, the tray should be
lined with a towel or paper wrap before placing the instrument. There should be
no direct contact between the carbon steel and the stainless steel trays.
2. Before placing an instrument into the sterilization tray, make sure that carbon
steel instruments are not in contact with stainless steel instruments. These
instruments should be separated and placed in different trays.
3. All instruments must be sterilized in an open position.
4. Place a sterilization indicator strip in each tray.
5. Once a week use a biological spore test indicator in any load to ensure
sterilization.
6. Make sure that all the instruments remain apart during the sterilization cycle.
7. Empty canisters should be placed upside-down in order to prevent accumulation
of water.
8. Do not overload sterilizer trays. Overloading will cause inadequate sterilization
and drying.
9. Allow a distance of approximately 25mm (1") between trays to permit circulation
of steam.
10. Wrapped instruments should be packed in material which promotes drying, such
as: Autoclave bags, autoclave paper and muslin towels.

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Note:
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).
4.1 Loading
Note:
Liquids can only be sterilized in an autoclave with two temperature sensors in the
chamber.
Every machine is supplied either with two (or more) stainless steel shelves, or with rails
for loading a loading cart from transfer carriage.
The transfer carriage is made of stainless steel and comes with adjustable legs to
balance the height of the loading cart to rails in the sterilizer chamber. The cart is
designed to slide smoothly off the carriage into the sterilization chamber.
The carriage moves on four heavy-duty castors, which are mounted on its base. The two
castors on the rear of the carriage are equipped with brakes. When the transfer carriage
is put in position for loading or un-loading the cart from the autoclave, the brakes must
be applied.
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.
Transfer Carriage Loading Cart

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4.2 Un-loading
1. When the buzzer signals the successful completion of a cycle, open the door
and let the load cool down for several minutes.
2. Maneuver the Transfer Carriage into position to line up the rails with the rails of
the autoclave, lock the two locking wheels.
3. Remove the loading cart (or the containers) onto the Transfer Carriage and
place aside to cool down.
4. Allow the load to cool down in an area with minimum passing traffic (to avoid the
possibility of touching the hot load), and without air movement (air conditioning,
etc.). Do not touch the hot load. Hot loads absorb moisture and may absorb
bacteria from the hand.
5. Do not transfer a hot load to metal shelves for cooling. Perform a visual
inspection to ascertain that sterilizing indicators have made the required color
change, and that the load is dry.
The load is to be rejected if:
a. The package has been compressed.
b. The package is torn.
c. The load is wet (water droplets signs).
d. The load fell on the floor.
e. Condense can be observed on the lid.
f. The PCD or other indicator present – Faulty cycle.

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Warning!
During loading and unloading use safety gloves and glasses in accordance with
local safety regulations and good practice.
Do not operate the autoclave in the presence of dangerous gases and vapors.
It is strictly forbidden for any person to enter the autoclave’s chamber.
If, for any reason (for cleaning, maintenance or if something falls down), and 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.
It is strictly forbidden for any person, to enter the service area behind the services
panels except trained technician.
If for any reason it is necessary to open the service 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