Table of contents Paragraph, page no. General 4 1.1 Incoming Inspection 4 1.2 Warranty 4 1.3 Warranty Statement 4 1.4 Accessories 5 1.5 Introduction 5 Safety Instructions 8 Technical Data 10 3.1 Operating Conditions 10 3.2 Directives and Standards 10 3.3 Environmental Emission Information 11 3.4 Electrical Data 11 3.5 Water Quality 12...
Page 4
5.3 Program 3: Liquid A 35 5.4 Program 4: Liquid B – Waste 36 5.5 Program 5: Liquid A – Cooling (C – cooling models only) 37 5.6 Program 6: Liquid B – Waste Cooling (C – cooling models only) 5.7 Program 7: Bio Hazard 1 (BH, bio-hazard models only) 39 5.8 Program 8: Bio Hazard 2 (BH, bio-hazard models only) 40 5.9 Program 9: Bio Hazard Liquids (BH, bio-hazard models only) 41...
Page 5
10.7 Closing and locking the door – MD models (mechanical door) 77 10.8 Closing and locking the door – D models (automatic door) 77 10.9 Starting a cycle 79 10.10 Unloading 79 ....................10.11 Stopping the process and cancelling the ERROR message 79 ....
(14) days of purchase or the warranty will be void. Our Technical Service Depts. can be reached at: Tuttnauer Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda, The Netherlands Tel: 31 (0) 765423510, Fax: 31 (0) 765423540 ...
All transportation charges must be paid both ways by the owner. This warranty will be void if the unit is not purchased from an authorized full service Tuttnauer dealer. 1.4 Accessories Basket accessories: A set of two baskets is available for the unit. The baskets are made of stainless steel wire and have a handle.
Page 8
protection, to ensure the safety of personnel and reliable operation with a minimum of down time. On both models, a printer is an optional addition to the autoclave. The printer prints the preset and actual parameters of the cycle (temperature, time and pressure/vacuum). The autoclave is equipped with an analog pressure gauge designed for reference only.
Page 9
In ELVWR-D (Water recycling) models, water is saved by the water saving system, because it recycles the water and re-uses it for each cycle in the following way: Water inlet by the pump from the reservoir and not direct from the plumbing.
2. Safety Instructions The autoclave has unique characteristics. Please read and understand the operation instructions before first operation of the autoclave. The following issues may require instructions guidance provided by the manufacturer: how to operate the autoclave, the door safety mechanism, the dangers involved in circumventing safety means, how to ensure that the door is closed, and how to select a correct sterilization program.
Page 11
On closing the autoclave's door, make sure it is properly locked before activating. Before withdrawing baskets, wear heat resistant gloves. Before opening the door, verify that there is no pressure in the chamber (chamber pressure gauge is located on the autoclave's front panel or door, depends on model).
13485:2012 (Quality Systems for Medical Devices) 9001:2008 (Quality Systems) 93/42/EEC (Medical Device Directive) Tuttnauer. Ltd. company also works in conjunction with and refers to: AAMI/ANSI-ST8 Hospital sterilizers ASME American Society of Mechanical Engineers Section VIII, Division 1, for unfired pressure vessels.
EN 285 Large Sterilizers UL 61010-1 97/23EEC IEC 61010-2-040 Safety IEC 61326-1 EMC 17665-1:2006 (Validation and Routine Control) 3.3 Environmental Emission Information Peak sound level generated by the sterilizer is « 70 / dBA with a back sound level of 60 dBA. Total heat transmitted by the sterilizer is <...
3.5 Water Quality 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 water supplied to condensate at steam generator/chamber inlet to sterilizer Evaporate residue...
3.5.1 Drain Cooling The feed water supplied to the drain cooling must meet the following requirements: Hardness: 0.7 - 0.2 mmol/l. Water temperature shall not exceed 15°C (59°F). 3.5.2 Reverse Osmosis A Reverse Osmosis (RO) system may be used to improve the quality of the water used to generate steam in the autoclave chamber.
Width 960mm 960mm Maximum 1690mm (1759mm dimensions Height 1460mm for WR (door open) configuration) Net weight (kg) 175kg 192kg Weight per support According to overall weight and area (max. load) floor loading requirements Shipping volume (m 1.35m3 1.35 m3 Shipping weight (kg) 210kg 227kg length...
Page 17
380-400V(3 Ph + Neutral + Earthing) 230V 1ph Frequency 50/60Hz 3.8.2 Other utilities Property Value Compressed Air (C, cooling models only 1/2" 3 Bar only) Tap water 1/2", 2-6 Bar See table in sec. Error! Mineral free water Reference source not found. 2"...
Ready” is door only) Displayed = 10 sec. Don’t Touch LAB048-0462 On the door frame Microswitches behind the door please Contact cover Tuttnauer Service Don’t Touch LAB048-0463 On the door frame Microswitches behind the door please Contact cover Tuttnauer Service...
3.10 Front View Description Description Front leg Display Rear leg Keyboard Left service door Printer cover Left service door grip Paper slot and paper cutter Service door lock screws Printer Door cover Main switch Door handle (MD models USB socket only) Pressure gauge Page 17...
3.11 Front View (WR Configuration, Inside Reservoir, Only Specific Items Are Shown) Description Glass tube indicator of the reservoir water level Inlet for manual water reservoir filling Page 18...
3.13 Rear View (WR Configuration, Inside Reservoir, Only Specific Items Are Shown) Description 1 Water reservoir drain outlet 2 Water reservoir overflow Page 20...
3.17 Safety Features include built-in safety features such Error message display. Electronic pressure and temperature measurement. Safety relief valve to avoid build-up of excessive pressure. Door switches enabling operation to be started only when the door is closed.
Page 26
Unsealed bottles (cooling without compressed air) On completion of sterilization, steam is exhausted from the chamber at a slow rate. When chamber pressure goes down to atmospheric pressure, water starts flowing through the cooling coil mounted around the outer side of the chamber. On conclusion of the cycle the water flow is stopped automatically, process is completed and it is possible to open the door and take out the sterilized goods from the chamber.
4.2 Description and Functions of the Front Panel Keyboard The front panel is composed of 3 sections: Display screen. Keypad. Printer 4.2.1 Display screen The display is a LCD panel used to display the current status of the autoclave while using Operational Messages and Error Messages. ...
Page 29
4.2.2 Keypad The keypad consists of three keys as described below: UP key This key has the following functions: In the menu directories: This key enables the operator to browse through the cycles. In the directories available: When the cursor is blinking on a number, the UP ▲ key increases its value.
4.2.3 Printer The printer is an optional device. It prints the detailed history of each cycle performed by the autoclave. The printing is on thermal paper with 24 characters per line and records the sterilization cycle information for subsequent consideration. 4.3 Displayed Error Messages / Symbols The failures are divided into two categories.
Page 31
This message is Enter the Admin menu displayed if the user as described in this presses START/STOP Cycle by clock manual to change the key while the "cycle by time or to cancel this clock" mode is active. option. This message id Open the door for 5 displayed in order to Atmospheric pressure not...
5. Sterilization Programs Sterilization Programs Temp. models models models only only only Icon Name 134°C Glass (273F) 121°C Plastic (250F) 121°C Liquid A (250F) 121°C Liquid B – Waste* (250F) Liquid A – 121°C √ Cooling* (250F) Liquid B 121°C Waste √...
Page 33
Sterilization Programs Temp. models models models only only only Icon Name Bio Hazard √ Liquids* (250F) √ Vacuum test (PV only)* 80 °C 11. Warm-Up* 176F) 80 °C 12. Isothermal* 176F) 121C 13. Air Mixture* (250F) 121C 14. Glass Test* (250F) 121C 15.
Page 34
The stages names are as follows: Start Pulse Low (PV models only) Pulse High (PV models only) Water Inlet Heating Sterilization Cooling (C models only) Exhaust Drying (PV model only) Ending During the process, the stages of the cycle will be displayed on the screen: Page 32...
5.2 Program 2: Plastic For plastic and other delicate instruments, when the manufacturer recommends autoclaving at temperatures of 121C (250F). Drying stage is available for PV (pre-vacuum) models only. Nominal parameters default settings Sterilization temperature: 121C (250F) Sterilization time: 15 minutes ...
5.3 Program 3: Liquid A For liquids when the manufacturer recommends autoclaving at temperatures of 121C (250F) for 15 minutes. Cautions! Both PT100 temperature sensors must be inside the bottles. For proper sterilization, fill the bottles with approximately the same amount of liquid. Nominal parameters default settings ...
Ending: The system checks that End temperature and End pressure have been reached, and then releases the door. 5.4 Program 4: Liquid B – Waste For liquids when the manufacturer recommends autoclaving at temperatures of 121C (250F) for 30 minutes, such as liquid waste. Cautions! Both PT100 temperature sensors must be inside the bottles.
Drying: N/A Ending: The system checks that End temperature and End pressure have been reached, and then releases the door. 5.5 Program 5: Liquid A – Cooling (C – cooling models only) For liquids when the manufacturer recommends autoclaving at temperatures of 121ºC (250F).
Fast Exhaust: the steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure. Drying: N/A Ending: The system checks that End temperature and End pressure have been reached, and then releases the door. 5.6 Program 6: Liquid B –...
Cooling: Forced cooling to the required end temperature, chamber pressure remains at approx. 300 kPa and the cooling valve is opened. Fast Exhaust: the steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure. ...
Sterilization: Sterilization temperature is maintained constant during the sterilization time. Cooling: N/A Fast Exhaust: the steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure. Note: If the cycle fails, fast exhaust is performed through the bio-hazard filter.
Operations sequence: (PV, pre-vacuum models only) Pulse low/Pulse high: at one pulse it will build vacuum down to 25 kPa. All exhaust from the chamber is performed through the bio-hazard filter. Water Inlet: Water enters the chamber Heating: The chamber is heated by actuation of electrical heaters until the sterilization temperature is reached.
Page 44
Cautions! Both PT100 temperature sensors must be inside the bottles. For proper sterilization, fill the bottles with approximately the same amount of liquid. Nominal parameters default settings Sterilization temperature: 121C (250F) Sterilization time: 45 minutes Operations sequence: (PV, pre-vacuum models only) Pulse low/Pulse high: at one pulse it will build vacuum down to 25 kPa.
5.10 Program 10: Vacuum Test (PV, pre-vacuum models only) Vacuum Test is a test program with the following parameters: Nominal parameters default settings Vacuum pressure: 17.0 kPa Vacuum time 1: 5 minutes Vacuum time 2: 10 minutes Operations sequence: ...
5.12 Program 12: Isothermal For liquids when the manufacturer recommends autoclaving at 60- 100C (140-212F) with no drying. Recommending for melting of agar, pasteurization etc. Caution! This is not a sterilization program! Put one PT100 inside the bottle, leave the second one hanging in the chamber outside the bottle (see below).
Keep Heat: Keep-Heat temperature is maintained constant for the preset Keep-Heat time. Cooling: N/A. Fast Exhaust: the steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure. Drying: N/A ...
Operations sequence: Heating: Air enters the chamber followed by steam that heats it up until the sterilization temperature is reached. Air adds pressure needed to prevent swelling or warping of soft plastic items. Chamber fan is used to mix air with steam. ...
Operations sequence: Heating: Steam enters the chamber and heats it up until the sterilization temperature is reached. During the interval of the heating stage, between 100°C and 121°C, the heating rate is kept to approximately a rise of 1 degree per minute.
Page 51
Cautions! Both PT100 temperature sensors must be inside the bottles. For proper sterilization, fill the bottles with approximately the same amount of liquid. Nominal parameters default settings Sterilization temperature: 121C (250F). Sterilization time: 15 minutes. Operations sequence: (PV, pre-vacuum models only) Pulse low/Pulse high: at one pulse it will build vacuum down to 25 kPa.
6. Checking and Changing Parameters and Other Data Bacsoft control panel allows changing parameters of the cycle and of the system, exporting various data to, and importing from, a USB device or to the printer, and some other options. Cycle parameters are changeable for Custom programs only (see Duplicate cycles), with the exception of the Temperature sensors, Displayed inputs, and Dry Time.
Note: To exit every screen and to return to the previous screen (to get one level up): move the cursor to Exit by pressing the UP or DOWN keys and then press the Start/Stop key. - or- press the UP and DOWN keys simultaneously. In the next chapter you will see how to change the required parameter as desired.
Page 54
Note: Please note the maximum and minimum values for this parameter shown on the screen. Your value must be within these boundaries. Below is the example of changing the Dry time parameter on the screen used in the previous section: Page 52...
Note: To exit every screen and to return to the previous screen: move the cursor to Exit by pressing the UP or DOWN keys and then press the Start/Stop key - or- press the UP and DOWN keys simultaneously 6.3 Quick options screen When the autoclave is on and no cycle is running, press Up and Down keys simultaneously to enter the Quick options screen.
Page 56
Below you can find instructions how to login and enter the Main menu. Section 6.1 above explains how to browse through the menus; section 6.2 explains how to change a parameter. Below is the explanation of some Quick Options. 6.3.1 Version Information This directory allows viewing information of the current, factory default, and previous software versions.
Page 57
6.3.2 Start cycle by clock This subdirectory enables the operator to start the cycle at the time set by this paramter. Enter the Start cycle by clock screen. The following screen will appear: On the Start cycle by clock screen, the time is displayed in the form “HH:MM”.
Page 58
Exit the Enabling the Start Cycle by Clock. The start cycle by clock icon appears on the display: Disabling the START CYCLE BY CLOCK On the Start Cycle by Clock screen, move the cursor to Disabled. Press Up or Down key to disable Starting cycle by clock. Exit the Enabling the Start Cycle by Clock.
Caution! After setting time and date, turn the autoclave off and then on again. 6.4 Logging in and entering the Main menu Below you can find instructions how to login and enter the Main menu. Section 6.1 above explains how to browse through the menus, section 6.2 explains how to change a parameter.
Choose User, then press the Start/Stop key to enter. The following screen will appear: 0000 is displayed on the screen with the cursor flashing on the right digit. Set the code to 0001. You will get to the Main menu. Below is the list and the explanation of some options available to user on the Main Menu.
Below is the typical parameter changing screen: 6.6 System Parameters This menu is listing the system parameters that are the same for all cycles. Browse to the following folder: Main menu\System parameters You will see the following screen: 6.6.1 Screen Saver n this menu you can define the screensaver delay time, i.
6.7 Maintenance Maintenance procedures provided by Bacsoft software allow you additional tests and USB input/output options. Browse to the following folder: Main menu\Maintenance You will see the following screen listing the maintenance options: Below is the instruction for autoclave’s maintenance menu. 6.7.1 Reset atmospheric pressure In this menu you can reset the atmospheric pressure value.
Note: Please reset the atmospheric pressure when you install the autoclave for the first time, and each time you relocate or calibrate the autoclave. 6.7.2 Printer test In this menu you can check the normal function of the printer. The printer will print the list of errors.
Page 64
Note: For all the standard sterilization cycles, and for Bowie and Dick test, the only changeable cycle parameter is dry time (you will not see other parameters on your screen). For the custom cycles created by duplication, and for the Warm Up cycle, more options are changeable. Operator is not allowed to create custom cycles;...
7. Screens 7.1 Screens following a complete successfully cycle – "Cycle Ended" 1. System Ready 2. Pulse Low (ELPV 3. Pulse High (1/1) model only) (ELPV model only) 4. Heating 5. Sterilization 6. Exhaust 7. Drying (ELPV 8. Ending 9. Cycle Ended model only) In order to open the door press START/ STOP key 7.2 Screens following aborted cycles after complete...
7.2.1 Canceled by user after complete sterilization stage The cycle ended successfully, the reason for aborted cycle is displayed. 7.2.2 Pressure Time Error Failure occurrence after complete sterilization stage The cycle ended successfully, the reason of failure is displayed. 7.3 Screens following a fail cycle: In this case, the display becomes yellow, a warning sign and the reason of failure will be displayed.
Page 67
7.3.2 Failure according to Cancellation by user before complete sterilization stage When "Cycle Failed" appears on the screen, the user shall press START/STOP key in order to delete the "Cycle Failed" message. An example for all displayed warnings according to Cycle Failed: Cycle Failed message Reason of failure...
8. Printer 8.1 Printer Output 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: Dry Time: ...
Page 69
Printer output Description ____________ Operator: To be filled in manually by operator Time: 12:14:47 Time sterilization cycle ended Status: Cycle Ended 00:24:43 101.3 099.7 Cycle finished time D 00:31:23 101.9 023.4 The time, temperature and pressure during drying The time, temperature and pressure during D 00:28:23 106.2 109.7...
program Unwrapped Cycle: Cycle name pouches Cycle Num: 000082 Cycle number Version A.B.CC.DD = 1.0.00.00 A: Door Type: Single Manual = 1 B: Vacuum Type = 0 Version: 1.0.00.00 C: Total number of Input/Output functionality that are not as default = 00 D: Total number of parameters values that are not as default = 00 Model:...
Page 71
Printer model PLUS II Front view 1-Paper mouth 2-STATUS Led (blinking – no paper, steady – status is OK) 3-OPEN key (for paper roll compartment opening) 4-FEED key 5-Paper roll compartment 6-Paper end sensor Fig. 1 Open the printer's cover door (1) by pulling it up (see Fig. 2). Fig.
Page 72
Fig. 3 Close the printer's cover door (1) by pulling it down, with the tip end of the paper emerging from the slot (2) (see Fig. 2). 8.2.3 Treating the thermal papers: Store the papers in a dry, cool and dark place. ...
9. Preparation before Sterilization The purpose of packaging and wrapping of items for sterilization is to provide an effective barrier against sources of potential contamination in order to maintain sterility and to permit aseptic removal of the contents of the pack. Packaging and wrapping materials should permit the removal of air from the pack, penetration of the sterilizing water vapor into the pack and removal of the sterilizing vapor.
Place instruments with ratchets opened and unlocked or clipped on the first ratchet position. Disassemble or sufficiently loosen multiple-part instruments prior to packaging to permit the sterilizing agent to come into contact with all parts of the instrument. Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that only minimal resistance to removal of air, the passage of steam and condensate will be met.
10. Operation 10.1 Draining and filling the water reservoir (WR only). Drain the water from the mineral free water reservoir once a week, and refill with fresh mineral-free water or distilled water 10.1.1 Draining Caution! Before starting, Make sure that the electric cord is disconnected and there is no pressure in the autoclave.
Caution! Use only water having the characteristics as per table in sec 3.11. Tap water may clog the system. A clogged system causes increase of pressure, which prevents temperature from rising. Turn on the main power switch. Caution! Under no circumstance should water be filled above the cooling coil.
The door is equipped with an electrical cylinder. This electrical cylinder perform the automatic opening and closing of the door. 10.3 Opening the door – MD models (mechanical door) Move the door handle (1) from position "locked" (2) to position "unlocked"...
Press the Key in order to open the door The following screen will be displayed: If the door has opened successfully, the following screen will be displayed: 10.5 Loading Load the autoclave properly according to instructions in sec. 9. ...
10.6 Selecting program Select the required program UP key: next program DOWN key: previous program Verify that you chose the required cycle. Attention: Selecting a program is possible only when the door is open. 10.7 Closing and locking the door – MD models (mechanical door) ...
Page 80
Warning! In order to close and lock the door push the door to the wall of the autoclave chamber (for about 10 seconds) until the "System Ready" message appears as shown below! While the door is locking the following screen will be displayed: When the door is properly locked, open door symbol will be replaced by the "System Ready"...
10.9 Starting a cycle Start the cycle by pressing the START/STOP key. 10.10 Unloading When cycle ended successfully (including pressing the START/STOP key, or any failure, after completing the sterilization stage) message "Cycle Ended" (and the relevant failure message, if applicable) is displayed on the screen.
Pressing the START/STOP key cancels the displayed message and enables opening the door. If the door is not opened, the vacuum pump will stop automatically after 30 minutes (ELPV model only). Warning The load has not completed a sterilization cycle, therefore it is not sterile.
Page 83
drainage of condensate. Additionally, correct loading will prevent damage to packs and their contents and maximize efficient use of the sterilizer. For detailed loading instructions, see sec. 9 (Preparation before sterilization) Unloading 10.14.3 On completion of the cycle, take out the load immediately from the sterilizer.
11. Service and Maintenance 11.1 Preventive Maintenance The maintenance operations described in this chapter must be fulfilled periodically in order to keep the autoclave in good working condition and to reduce the breakdown time to a minimum. The user’s maintenance personnel, according to the following instructions can easily execute these operations.
11.1.3 Periodically Every 1 month, or if the cycle fails because of "low-heat", sterilize and clean the bio-hazard filter, according to para. 10.7. Every 100 cycles replace the bio-hazard filter, according to para. 10.7. Every 6 months replace the air filter, (if installed) (to be done by an authorized technician).
11.3 Replacing the Safety Valve -- ASME approved type Warning: Before starting, disconnect the instrument from the power source and ensure that there is no pressure in the autoclave chamber. Note: The safety valve is located on the rear of the autoclave. Remove the safety vale cover (2) by pressing both sides of the cover inwards (1) and pulling it out (3) of its seats (slots in the rear wall of the autoclave -4) to reveal the safety valve (5).
Page 88
For ASME valves: Pull the ring of the safety valve using a tool, i.e. screwdriver, hook etc. and lift the safety valve ring for 2 seconds. Be careful not to burn your hands. For PED valves: Turn the pressure relief nut counterclockwise for 2 seconds. Verify that steam escapes from the valve.
12. Troubleshooting This troubleshooting chart enables the user to solve minor malfunctions, prior to contacting our service department. Only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to service the apparatus.
Page 90
Message / Symbol / Failure Description Corrective Action Problem damaged. Perform a new cycle. Message is displayed and FAIL indicator lights if in Call for service. the air removal stage a The bio-hazard vacuum level of 25kPa is not filter may be clogged. Vacuum’...
Page 91
Message / Symbol / Failure Description Corrective Action Problem This message is displayed if Chamber Pressure drops below the sterilization pressure Perform a new cycle. Pressure (134°C = 304 kPa, 121°C = 205 kPa) for 2 seconds during the sterilization stage. This message is displayed if the pressure in chamber does Check and fix the...
Page 92
Message / Symbol / Failure Description Corrective Action Problem Wait until "cycle failed – canceled by user" or This message is displayed Canceled "cycle end – canceled by after the START/STOP key is By User user" is displayed. pressed and cycle aborted. Perform a new cycle.
Page 93
Message / Symbol / Failure Description Corrective Action Problem Compresse d air supply This message is displayed in Check and fix the air error (digitat case of a compressed air supply. input supply malfunction. option) check and fix the mineral free water This message is displayed if supply.
13. Baskets and Containers Container for waste products High Basket Low Basket Stainless steel container for Type Stainless steel wire baskets waste products, with vent holes Model Dia. x Height (mm) Capacity Dia. x Height (mm) Capacity 465 x 235 474 x 350 5050 465 x 350...
14. Spare Parts List Description Cat. No. Cap for ¼” strainer FIL175-0027 Strainer element FIL175-0046 Teflon gasket 4 mm GAS082-0008 15. Accessories Description Cat. No. Printer, PLUSII-S2B-0004 THE002-0052 Thermal paper for CUSTOM PLUSII printer, roll 57mm THE002-0066 d=50mm High BSK507-0001 Stainless steel wire basket BSK507-0003...
Need help?
Do you have a question about the 5050 ELV-MD and is the answer not in the manual?
Questions and answers