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Operation and Maintenance
Manual
Pre-vacuum B-class Steam Sterilizer
T-Edge
REF: AMS10-230-PED-T, AMS10-230-W-PED-T,
AMS10-230-T, AMS10-230-W-T
Cat. No. MAN205-0502001EN Rev G
May 2020
Tuttnauer Ltd. Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel
Tel: +972-2-9904611
Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR Breda, P.O. Box 7191, 4800 GD Breda,
Netherlands.
Tel: +31/76-5423510, Fax: +31/76-5423540
1
To Purchase, Visit
Avobus.com
or call
1-800-674-3655
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Table of Contents
Troubleshooting
Related Manuals for Tuttnauer T-Edge AMS10-230-PED-T
Summary of Contents for Tuttnauer T-Edge AMS10-230-PED-T
- Page 1 Cat. No. MAN205-0502001EN Rev G May 2020 Tuttnauer Ltd. Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel Tel: +972-2-9904611 Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR Breda, P.O. Box 7191, 4800 GD Breda, Netherlands.
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Page 2: Table Of Contents
Table of Contents 1 GENERAL INFORMATION ........................5 ........5 ANUFACTURER AND UROPEAN UTHORIZED EPRESENTATIVE NFORMATION ................5 PPLICABLE EGULATION AND UALITY TANDARDS 1.2.1 And in consideration with: ..................... 6 ..........7 EGEND FOR YMBOLS APPEARING ON THE ABELS AND IN THIS ANUAL .................... - Page 3 ....................... 33 ETTING ATE AND ........................34 ATE AND CONTROL PANEL ........................35 ................... 36 OME SCREEN ESCRIPTION AND UNCTIONS ......................37 PENING THE EVICE ........................38 TARTING A YCLE ............... 42 VAILABLE TERILIZATION ROGRAMS AND ROGRAMS 8.4.1 List of available Sterilization and Test Programs (refer to sec.8.4.2 for maximal allowed weight of load) ..........................
- Page 4 List of Tables Table 1 - Device labeling ..........................8 Table 2 -Device Properties ........................14 Table 3 - Device Electrical Data ........................ 15 Table 4 - Utility Requirements ........................15 Table 5 - Water Quality ..........................16 Table 6 - Safety Warnings and Precautions ....................18 Table 7 - Device Package ..........................
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Page 5: General Information
1 General Information Manufacturer and European Authorized Representative Information T-Edge Autoclave is manufactured by Tuttnauer Ltd., Located Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel. Tel: +972-2- 9904611 The European Authorized Representative is Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR Breda, P.O. -
Page 6: And In Consideration With
IEC 61010-1 3.1 Edition, January 2017 Safety Requirements for electrical equipment for measurement control and laboratory use. EN 61010-2-40: 2015 Safety requirements for sterilizers and washer- disinfectors used to treat medical materials. EN ISO 15223-1: 2016 Symbols for use in the labeling of medical devices. -
Page 7: Legend For Symbols Appearing On The Labels And In This Manual
Legend for Symbols appearing on the Labels and in this Manual Manufacturer European Authorized Representative Year of Manufacturing Catalog Number Serial Number Consult the Operation and Maintenance Manual (User Manual) before use IP31 Ingress Protection European compliance Mark of compliance with the European Medical Device Directive (Number xxxx identifies the Notified Body that performed the examination) European compliance Mark of compliance with the... -
Page 8: Table 1 - Device Labeling
Disposal according to electronic scrap ordinance This side up (during transport and shipment) Fragile (during transport and shipment) A warning or precaution as detailed in the Operation and Maintenance Manual (User Manual) Caution! Hot Surface Table 1 - Device labeling... -
Page 9: General Description Of The Device
The device features built-in memory to record up to 999 sterilization cycles. These can be exported to a USB device to be transferred to a PC. The device has a built-in Network Port for use with optional Tuttnauer’s R.P.C.R software when connected to your local network. -
Page 10: Intended Use
Tuttnauer. Tuttnauer’s obligation is limited to the repair or replacement of parts for the autoclave. This warranty will be void if the unit is not purchased from an authorized Tuttnauer dealer. -
Page 11: Warranty Statement
Breda, The Netherlands Tel: 31 (0) 765423510, Fax: 31 (0) 765423540, Email: info@tuttnauer.nl Or at: Tuttnauer Ltd., Har – Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel Tel: +972-2-9904611 Customer Inspection Upon Receival of the Device Upon receiving your Tuttnauer Autoclave, carefully inspect the outside of the shipping carton for signs of damage. -
Page 12: Typical Pressure And Temperature Versus Time Diagrams For The Operating Cycles
Manufacturer Sterilization Performance Validation The sterilization performance validation of all sterilization programs and test programs were performed by the manufacturer according to EN 13060. Typical Pressure and Temperature versus Time Diagrams for the Operating Cycles The diagrams are shown in Appendix A... -
Page 13: Device Specifications
Device Specifications 1.11.1 Device Overall Dimensions: Front view Side view Top View To Purchase, Visit Avobus.com or call 1-800-674-3655... -
Page 14: Device Properties
1.11.2 Device Properties Property Dimension Width 48cm Height 49 cm External size 58 cm (supporting common install base Depth carry a 60 cm counter top) Diameter 25 cm Chamber Depth 46 cm volume 23lit Usable chamber space 75% (~17 L) Max. -
Page 15: Device Electrical Data
1.11.3 Device Electrical Data Property Value Total Power 2000W Voltage 1Ph / 230 VAC Amperage Protection against Class I (IEC 60601-1) electrical shock Mains supply fluctuation +/- 10% Frequency (Hz) 50Hz Table 3 - Device Electrical Data 1.11.4 Utility Requirements Property Value Mineral free water... -
Page 16: Device Environmental Information
Device Environmental Information The peak sound level generated by the autoclave is 67dBa with background noise of 48 dBa during sterilization stage, and 65 dBa during drying stage. The total heat per hour transmitted by the autoclave is <200Wh. Device Environmental Information ... -
Page 17: Tap Water Supply
Caution: 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 conductivity of 15 µs/cm. Conductivity greater than 15 µs/cm may cause failures. -
Page 18: Safety
Safety Principle Safety Warnings and Precautions Always operate the autoclaves strictly as instructed in this user manual. Caution! Instruments should not be loaded into the autoclave to be sterilized unless Steam Sterilization is instructed in their User Caution! Manual. The instructed Steam Sterilization Program should be verified against the programs available in this autoclave. -
Page 19: Safety Notes
Safety Notes All new autoclave users must undergo a period of training in proper usage under an experienced employee. Before initial use, check the autoclave chamber to ensure that no packaging materials have been left inside. Before use, check inside the autoclave chamber to ensure that no items have been left from the previous cycle. -
Page 20: Content Of The Device Package
Safety pressure valve to prevent over-pressurizing of the chamber. Mind the Power socket. Keep it and its vicinity dry. Danger of electrocution. Warning! Content of the Device Package Table 7 - Device Package Part Number Part Description Quantity Supplied AMS10-230-W-PED-T T-Edge Autoclave DEV000... -
Page 21: Depiction Of System Parts
Depiction of System Parts Front View No. Description Description Touch screen Door switches On/off switch Air filter Chamber Door USB socket Door Gasket Door Handle Mineral-free (left) and waste water (right) Mineral-free water reservoir opening reservoir drains Chamber Chamber Table 8 - Front View... -
Page 22: Rear View
Rear View No. Description Description USB ports Waste outlet Mineral free inlet (available in AMS10- LAN socket 230-W-T/ AMS10-230-W-PED-T only) Cut-off Thermostat Safety valve Circuit breaker on off Aeration Ventilation opening switch Power socket Table 9 - Rear View Mind the Power socket. Keep it and its vicinity dry. Danger of electrocution. -
Page 23: Installation Instructions
Installation Instructions Lifting and Carrying Cautions! Before moving the autoclave, make sure that the electric cord is disconnected from the power, and there is no pressure in the chamber. Drain the water from the reservoir (see Draining the reservoir, 8.9) Do not drop the device! To avoid injuries, lifting and carrying should be done with at least two persons or by using a fork-lift or any other mechanical aid. -
Page 24: Connections To Utility Supplies
9. The operational altitude shall not be over 4000 meters. 10. Ambient pressure shall not be lower than 60.5 KPa (if the altitude and temperature are kept in the manufacturer's instructed ranges above, and no forced extreme negative pressure is applied near the autoclave, then ambient pressure of 60.5 KPa or higher is guaranteed, as it is a function of altitude and temperature). - Page 25 3. When you turn on the autoclave, it will automatically warm up. Warning! Be careful the surfaces may be hot! 4. Fill the Mineral Free Water Reservoir with water meeting the quality specs (see Water Quality and Filling the Mineral-Free Water Reservoir). 5.
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Page 26: Pre-Sterilization Cleaning And Disinfection Of Instruments And Their Loading Into The Device
The item manufacturer’s instructions always supersede any other instructions. Clean instruments immediately after use to remove any residue. It is recommended that all instruments be ultrasonically cleaned using Tuttnauer’s Clean & Simple enzymatic cleaning tablets or other suitable solution. - Page 27 After cleaning, rinse instruments under tap water for 30 seconds and pat or air dry to remove residual minerals. If your tap water has a high mineral content, then rinse a second time in a bath of distilled water to remove minerals and pat dry.
- Page 28 Tubing should be rinsed after cleaning. When placed in the tray, make sure that both ends of the tubing are open and there are no sharp bends or twists. Cassettes should be placed on the tray rack in place of the trays. They should not be touching each other or the Chamber walls.
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Page 29: Operating Instructions
Operating Instructions The following are the operation instructions. Turning on the Device Plug the power cord into the socket on the rear panel of the autoclave (see the rear view) and into the wall outlet. Turn on the ON/OFF switch mounted under the cover (see below) -
Page 30: Filling Water
Filling Water Cautions! In the beginning of each day, check water level in the reservoir. Note: Improper Water level icon appears when the water reservoir needs to be filled. See the ‘filling procedure’ (7.3 below) and ‘Draining the Reservoir’( A general alarm symbol will appear. -
Page 31: Filling Water In The Reservoir
Filling water in the reservoir Use only water having the characteristics stated in Water Quality. Note: Using tap water will clog the system and invalidate the manufacturer’s guarantee. To fill water in the reservoir: Lift up the water reservoir cover (see below). Pour water into the reservoir through the water filter on top of the autoclave unit. - Page 32 Please note: Prion program requires the demineralized water level in the reservoir to be filled to the in maximum level in order to start the program, otherwise an alert will be prompted "please fill water tank to full for start".
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Page 33: See The Requirements Concerning Water Quality , In Section 1.14
See the requirements concerning Water Quality, in Section 1.14 Setting Date and Time Note: The Initial log-in including setting of drying time as well as other initial parameters will be performed only by a qualified technician upon installation On the main screen, press the menu symbol to open the settings screen. -
Page 34: Set Date And Time
Set Date and Time Press the Set Date and Time icon to open the Set Date and Time screen. This quick option enables the operator to set the machine date and time. Select day, month and year, as depicted: After adjusting the date and time, the system will automatically restart. To Purchase, Visit Avobus.com or call... -
Page 35: Control Panel
Control Panel The display is a graphic Touch screen LCD panel used to display the autoclave current status, any Operational or Error Messages and for operating the machine. Image 1: Home screen –Program Select Screen This screen will be presented when the autoclave is switched on: Additional programs are accessible by paging using the side arrows (see next page) Please note: Prion program requires the demineralized water level in the reservoir to be filled to the in maximum level in... -
Page 36: Home Screen Description And Functions
Home screen Description and Functions Icon Name Description Home icon immediate use only Menu Menu selection icon Unwrapped 134 Exposed Unwrapped load program Pressure Momentary Pressure in the chamber Temperature Momentary temperature in the chamber Load no. ID Load cycle number Date and time It enables the operator to set the machine date and time screen Water full... -
Page 37: Opening The Device Door
Opening the Device Door This machine is equipped with an electronic door lock. The door is locked when either the system is running a sterilization cycle, or there is pressure in the chamber, or the power is off. If you need to open the door after cycle completes, press the confirm button: In any case, if the door is not locked, it can be opened as illustrated below. -
Page 38: Starting A Cycle
Starting a Cycle It is recommended to perform B&D test cycle at the beginning of each working day. Before each cycle, check visually that the gasket is intact, not loose and clean. Load the autoclave properly (see chapter 6). Choose the appropriate sterilization program. Note: The program can only be selected when the door is open. - Page 39 6. Close the door by both: Pushing the door gently; Turning the handle clockwise while pushing the door until it comes to the closed position, then releasing the handle. When the door is closed, the open-door symbol is replaced with the closed-door symbol...
- Page 40 Press the Start button to start the cycle. For cycle process description see Sterilization Cycle Description. Warning! Do not remove the top plastic cover during a running cycle. Hot water / steam may exit! After pressing start the sterilization process starts Image 3: screen display while "Unwrapped 134"...
- Page 41 Note: For the results of the cycle, see description in paragraph 8.5.
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Page 42: Available Sterilization Programs And Test Programs
Available Sterilization Programs and Test Programs List of available Sterilization and Test Programs 8.4.1 (refer to sec.8.4.2 for maximal allowed weight of load) Sterili- zation Dry time Type of Cycle Icon Name Temp Load type time (minutes) type (min.) Unwrapped 1 (default) immediate Unwrapped... -
Page 43: Maximum Load Weight Per Load Type
The sterilization program can be used for sterilizing lumen device of no longer than 230mm and no smaller than 3.4mm. This sterilization program can be used in sterilizing up to five dental handpieces. 8.4.2 Maximum Load Weight per Load type Load type Maximum Suitable for programs... -
Page 44: Description Of Bowie-Dick Test Stages
8.4.5 Description of Bowie-Dick Test Stages Air-removal stage: vacuum pulses are performed. Heating stage: steam is inserted into the chamber until the sterilization temperature and pressure are reached. Sterilization stage: temperature and pressure are maintained constant at the pre-set level for sterilization time. Fast exhaust stage: steam is exhausted out of the chamber at a fast rate until pressure decreases to ambient pressure. -
Page 45: Cycle Succeeded / Cycle Failed Notifications And Follow-On
Cycle Succeeded / Cycle Failed Notifications and Follow-on 8.5.1 Cycle Succeeded When the cycle has ended successfully, the following "Successful" message is displayed: Push the confirm button to confirm the "Successful" message. Proceed to chapter "Opening the door and Unloading". -
Page 46: Cycle Failed
8.5.2 Cycle Failed In the event of a failure at any stage, the exhaust valve will be opened to release pressure from the chamber, the message "Fail" and a relevant failure message will be displayed on the screen: Warning! The load has not completed a sterilization cycle; therefore, it is not sterile. -
Page 47: Aborting A Cycle
Aborting a cycle It is possible to stop the cycle while the autoclave is operating. Press the Stop button at any stage (except exhaust) of the process to stop the operation. If the cycle is aborted, the load is not sterile. A “fail” message will be displayed with an error message explaining the reason for the failure. -
Page 48: Opening The Door And Unloading
Opening the door and Unloading 1. Push the button to confirm the "Successful" or the "error" message to unlock the door. 2. Open the door. Caution! Open the door a little to release the steam from the chamber. Only after the steam escaped, open the door widely. -
Page 49: Checking Waste Water Level
Checking Waste Water Level When the waste water level is high, the general alarm symbol will appear. A relevant text alarm will appear in the alarms list. This situation is normal, but the operator cannot run a new cycle before draining the waste water reservoir (see ‘Draining the Reservoir’... - Page 50 To drain the reservoir: 1. See item (5) with the plastic hose (6) attached to it (supplied with the autoclave). Clean Water Waste Water 2. Put the other end of the hose into a drain bucket. 3. Insert part (5) into valve (3) and press it until you hear a click. The drain valve opens immediately.
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Page 51: Preventive And Scheduled Maintenance To Be Performed By The Operator
Note: Technician manual describes the maintenance operations required from qualified technician, every two months and once a year. Should the need arise, technical assistance or a service technician can be requested by either calling your dealer or Tuttnauer Europe. Daily Maintenance Caution! Make sure the autoclave is not hot before cleaning it. -
Page 52: Monthly Maintenance
Monthly Maintenance Caution! Make sure the autoclave is not hot before cleaning it. Turn the unit on momentarily to allow the door to be opened. Open the door, unplug the autoclave again, and proceed with cleaning. Clean and descale the chamber. ... -
Page 53: Periodic Maintenance
Periodic Maintenance Caution! Make sure the autoclave is not hot before cleaning it 1. Replace the air filter, every 6 months or after 1000 cycles (whichever comes first) according to 12.3. 2. Every 3 months check the door gasket for any signs of physical damage and ask the technician to replace it if there is tear or leakage. - Page 54 3. Connect the new filter. 4. Screw in the new filter. 5. Ensure the new filter is all the way in and seated properly. Note: make sure that the arrow on the filter body points inwards, toward the chamber. Make sure that you don’t bend the filter pipe when reattaching it. Note: It is recommended to replace the air filter every 6 months or after 1000 cycles (whichever is the shorter period).
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Page 55: Cleaning The Drain Filter
9.4.2 Cleaning the Drain Filter Caution! Make sure the autoclave is not hot before cleaning it Cautions! Before proceeding, make sure that the electric cord is disconnected and there is no pressure in the chamber. 1. Clean the drain filter, every month. The DRAIN filter (1) is located inside the autoclave chamber at the bottom far end, to reach the filter open the autoclave chamber door, remove the tray (see below). -
Page 56: Replacing The Drain Filter
9.4.3 Replacing the Drain Filter Note: If after successive cleaning of the filter the result is not satisfactory proceed to the replacement of the drain filter (paragraph 9.4.3 below). Cautions! Before proceeding, make sure that the electric cord is disconnected and there is no pressure in the chamber. Use scissors to open the filter bag and not sharp blades or pointed instrument. - Page 57 5. Screw the new Drain filter assembly, (P/N: CMT511-0048) to its place in the chamber bottom, tighten it with the M14 wrench. 6. Ensure the new filter is all the way in and seated properly. 7. Place the shelf (2) back.
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Page 58: Full List Of Informative Screen Display Symbols, Operating Messages, Error Messages And Troubleshooting
Full List of Informative Screen Display Symbols, Operating Messages, Error Messages and Troubleshooting The troubleshooting section is provided in order to enable the user to solve minor malfunctions, prior to contracting our service department. However, only technical personnel having proper qualifications and holding technical documentation (including a technician manual) and adequate information are authorized to serve the apparatus (See TABLES 13 &... -
Page 59: Error Messages & Troubleshooting
Symbol / Message Required Action (if Symbol / Message Description applicable) Press to watch the alert Alert description When cycle is selected it is ---- highlighted in red The "cycle succeeded" message and symbol are ---- displayed when the cycle ends successfully. - Page 60 Symbol / Required Action (if Symbol / Message Description Message applicable) This message is displayed if the temperature raises 4°C above Perform a new cycle. If the "High Temp" sterilization temperature during the problem persists, call for sterilization stage for 2 seconds service.
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Page 61: Table 14 - Error Messages & Troubleshooting
Symbol / Required Action (if Symbol / Message Description Message applicable) after preset time, during the air removal stage. "Door is open Close the door to perform a This message is displayed when the (During the new cycle. door is open: During the cycle. cycle)"... -
Page 62: Tsc Printer Installation (Optional)
How to set, operate, use and maintain the printer after the first installation. General printer information The printer(s) are optional and can be purchased/ordered from Tuttnauer by the customer, the printers can easily be installed and connected to the autoclave following the instructions below. - Page 63 For an example of a typical printout, see next page.
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Page 64: Important Safety Instructions
Important safety instructions 1. Read all the instructions and keep them for future use. 2. Follow all warnings and instructions on the product. 3. Disconnect the power plug from the AC outlet before cleaning or if fault happened. Do not use liquids or aerosol cleaners. Using a damp cloth is suitable for cleaning. -
Page 65: Installation For The First Time
Installation for the first time Unpacking the printer: 1. Carefully open the printer box (1) and remove the printer packing. 2. Place the printer (2) on the table, and remove the two tapes (3). 3. Remove the rest of the box content which includes USB communication cable (6), electrical power cable (7), CD (5), adapter (8), blue cable (9), and the printer instructions (4). -
Page 66: Open The Printer Top Cover
Open the printer top cover 1. Remove the two tapes bonding the printer body to its cover (1) on each opposite sides of the printer. 2. Pull the two handles left and right (2) simultaneously together forward as shown by the arrows in figure 1. -
Page 67: Loading Thermal Printer Paper Roll/ Label Roll
Loading thermal printer paper roll/ Label roll You can either load a thermal paper roll, or label roll on the printer roll compartment opening. You can also connect two printers to the autoclave, one loaded with thermal paper roll, and the second printer loaded with label roll. 1. - Page 68 5. Insert the paper under the two paper guides (item 6) in figure 3 for the paper roll, pull the paper to extend it beyond the printer. Do the same for the label roll (item 6) figure 4. Figure 3 Figure 5 Printer Figure 3 paper roll Figure 4 Label roll.
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Page 69: Connecting The Interface Cables To The Printer
Connecting the interface cables to the printer 1. Connect the adapter male (1) to the RC-232 Output Port blue cable female plug connection (2), tighten and secure the 2 screws (3) to the adapter. 2. Plug the adapter connected with the blue cable (8) to the printer adapter connection, Tighten the 2 screws (4). -
Page 70: Connecting Power And Interface Cables
Connecting power and interface cables 1. Connect the RC-232 Output Port blue cable (6) to the back of the autoclave (4). 2. Connect the power cable plug connector of cable (6) coming from the printer to the electrical power source on the wall. 3. -
Page 71: Starting The Printer
Starting the printer 1. Press on the button in the front of the printer cover, keep pressing the finger while switching on the printer power at (1) the printer back. (Step 1 and 2 shall be done simultaneously). 2. Switch on the printer power (1) at the printer back, keep pressing the finger in step 1 until the red light bulb in front start flashing. -
Page 72: Setting Printer Definitions
Setting Printer definitions The following are the login procedures for new user: Press on the quick menu 2. . Press on icon. 3. Enter administration password Select from drop down list. 4. Press Login Enter administration password Select from drop down list. 5. - Page 73 7. Press on system parameters 8. Select for paper roll printer type 6. Select for label roll label 1, (See screen example above). 9. If only the one printer is connected to the autoclave, local=0 or printer=1,.The following table gives the various printer possibilities Printer Type Local Only paper roll 6...
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Page 74: Factory Codes For End User
Factory Codes for end user Notice: Please, find below Factory Codes for end user. These codes are similar to all T-Edge machines from version 1.0. Level 1 Factory Code 010 7N613IOJT6 Admin - for User Manual Level 1 Factory Code 011 4YFBH5G597 Admin - for User Manual Level 1 Factory Code 012... - Page 75 Level 1 Factory Code 034 OTEWS95KOU Admin - for User Manual Level 1 Factory Code 035 AOUMETCLQ1 Admin - for User Manual Level 1 Factory Code 036 7Z1X0PZVHD Admin - for User Manual Level 1 Factory Code 037 RGQHB6D4R7 Admin - for User Manual Level 1 Factory Code 038 APZJ5F1IT3 Admin - for User Manual...
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Page 76: Appendix: Typical Pressure And Temperature Versus Time Diagrams For The Operating Cycles
Appendix: Typical Pressure and temperature versus Time Diagrams for the Operating Cycles Recorded "Vacuum Test" cycle with empty chamber: To Purchase, Visit Avobus.com or call 1-800-674-3655... - Page 77 Recorded "Bowie-Dick" cycle with empty chamber:...
- Page 78 Recorded "Unwrapped 134" cycle with full load of solid instruments:...
- Page 79 Recorded "Wrapped 134" cycle with full load of porous type and double wrapped: To Purchase, Visit Avobus.com or call 1-800-674-3655...
- Page 81 Recorded "Unwrapped 121" cycle with full load of solid instruments:...
- Page 82 Recorded "Wrapped 121" cycle with full load of porous type and double wrapped: To Purchase, Visit Avobus.com or call 1-800-674-3655...
- Page 83 To Purchase, Visit Avobus.com or call 1-800-674-3655...
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