TABLE OF CONTENTS PARAGRAPH PAGE NO. GENERAL ......................4 Introduction ....................4 Incoming Inspection ..................5 Warranty ......................5 Warranty Statement ..................6 Accessories....................6 SAFETY INSTRUCTIONS ..................7 TECHNICAL DATA.....................9 Storage Conditions..................9 Operating Conditions...................9 Directives and Standards ................9 Environment Emission Information ............10 Electrical Data ................... 10 Specifications .....................
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6.14 Program 14: Warm Up (Optional)............. 39 6.15 Program 15: Isothermal (Optional)............40 SCREENS ......................41 Screens following a completely successful cycle – "Cycle Ended" ..41 Screens following aborted cycles after complete sterilization stage ..42 Screens following a fail cycle: ..............42 CHECKING AND CHANGING PARAMETERS AND OTHER DATA ...44 Directories and subdirectories ..............44 Entering the main menu ................45...
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TABLE OF CONTENT (Cont.) DRAWINGS PAGE NO. OVERALL DIMENSIONS ..................11 FRONT VIEW ......................13 REAR VIEW ........................14 CONTROL PANEL DRAWING ..................19 BASKETS AND CONTAINERS .................85 Page 3 of 86 Pages...
GENERAL Introduction Model 3870 ELCPVGBH-D is a laboratory sterilizer designed especially for the sterilization of instruments, liquids, and other materials in hospital laboratories (including the medical waste), medical laboratories, research institutes, food laboratories and pharmaceutical facilities. The PV (pre-vacuum) models are equipped with a vacuum pump. The advantages of the pre-vacuum sterilizer in comparison to the regular gravity displacement steam sterilizer are as follows: —...
All Tuttnauer products are carefully inspected prior to shipment and all reasonable precautions are taken in preparing them for shipment to assure safe arrival at their destination.
(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, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510, Fax: +31/76-5423540, E-mail: info@tuttnauer.nl...
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.
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Open the door slowly to allow steam to escape and wait 5 minutes before you remove the load. When sterilizing liquids, wait 10 minutes. Once a month, ensure that the safety valves are functioning, and once annually a certified tester must conduct pressure chamber safety tests. Once annually, or more frequently, effective tests must be performed, i.e., calibration and validation.
TECHNICAL DATA Storage Conditions The packed or unpacked autoclave shall be retained in indoor conditions! Operating Conditions The autoclave is intended to work in ‘indoor’ conditions only. Only autoclavable materials shall be used. The environment shall not exceed an ambient temperature range of 5ºC (41ºF)-40ºC (104ºF) and a relative humidity of 85% respectively.
1. EN ISO 9001:2008– Quality System 2. ISO 13485:2003 – Quality systems – Medical devices. Environment Emission Information A. Peak sound level generated by the sterilizer is < 70dBA with a back sound level of 60 dBA. B. Total heat transmitted by the sterilizer is < 100 W/h Electrical Data 208V 230V...
OVERALL DIMENSIONS Construction Chamber and door material Stainless steel Outer Cabinet Stainless Steel Chamber insulation Fiberglass with reinforced material Utilities 3.8.1 Electrical utility Power Recommended Circuit Breaker 380-400V(3 Ph + Neutral + Earthing) Frequency 50/60Hz 3.8.2 Other Utilities Compressed Air 1/2"...
Attention: A switch or circuit-breaker must be included in the building installation. This switch or circuit-breaker shall be in close proximity to the equipment, within easy reach of the operator; and marked as the disconnecting device for the equipment. ...
FRONT VIEW Description Description Front leg Printer cover Generator Pressure Gauge Service Door Rear Leg Door cover Chamber Pressure gauge USB socket RJ45 connector Display Printer Keyboard Main switch Page 13 of 86 Pages...
REAR VIEW Description Description Service door Rear leg Generator safety valve Mineral-free water drain Chamber safety valve Tap water drain Compressed air inlet Overflow Air pressure gauge Mineral-free water inlet Air pressure regulator Tap water inlet Service door Power cable socket Front leg Circuit breaker Page 14 of 86 Pages...
WATER QUALITY The distilled or mineral by two water systems: to the sterilizer shall be according Tap water for the vacuum pump: Hardness should not exceed 0.7:2 mmol/l S Pressure should be in the range of 2–5. bar (30–70 psi) ...
Hardness: 0.7 - 0.2 mmol/l. Water temperature: shall not exceed 15°C. Note: The use of heavy scaled water for the vacuum pump cooling, can cause blocking of the rotor and put the pump out of operation. This invalidates the guarantee for the vacuum pump. Reverse Osmosis A Reverse Osmosis system may be used to improve the quality of the water used to generate steam in the autoclave...
4.4.2 Heat The ELCPVG-D is equipped with a steam generator that maintains a constant steam pressure. After a cycle has been initialized and air removal stage has been completed, steam is introduced into the chamber. The temperature and pressure in the chamber increase until appropriate levels are reached.
automatically, process is completed and it is possible to open the door and take out the sterilized goods from the chamber. Operations Sequence Vacuum is produced into the chamber down to 15-5 kPa. The vacuum pump stops. Note: During the test period the autoclave is not heated. 4.4.5 Exhaust When the timed sterilization cycle is complete, the unit...
Description and Functions of the Front Panel Keyboard The front panel is composed of 3 sections: 1. Display screen. 2. Keypad. 3. Printer 5.1.1 Display screen The display is a LCD panel used to display the current status of the autoclave while using Operational Messages and Error Messages.
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5.1.2 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 cycles. In the directories available: o When the cursor is blinking on a number, the UP ▲...
5.1.3 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. Displayed Error Messages / Symbols The failures are divided into two categories.
Displayed operational messages / Symbols Message / Message / Symbol Symbol Required Action Description Name This symbol is displayed Close the door. when the door is open. This symbol is displayed when there is water in Repeat the cycle chamber. This message is displayed Door is open when the door is opened: In...
STERILIZATION PROGRAMS The autoclave offers thirteen sterilization programs as follows: Sterilization Programs Drying Sterilization Time Temp Time Icon Program Description (minutes) (minutes) Glass 134°C Plastic 121°C Liquid A 121°C Liquid B -- Waste 121°C Liquid A – Cooling 121°C Liquid B -- Waste 121°C Cooling Waste...
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Warm Up (Optional): Pre-warming the chamber 95°C (warm-up shortens the sterilization stage) Isohtermal (Optional): The cycle is intended for preparation for 60 °C sterilization, pasteurization, and melting of agar. Note: The sterility of instruments processed in unwrapped cycles cannot be maintained if exposed to non-sterile environment.
Program 1: Glass For glass instruments, when the manufacturer recommends autoclaving at temperatures of 134C (273F). Nominal parameters default settings Sterilization temperature: 134C (273F). Sterilization time: 3 minutes. Drying time: 1 minute. Operations sequence: (PV, pre-vacuum model only) Air removal stage; four vacuum pulses remove air by drawing the chamber down to 20kPa.
Program 2: Plastic For plastic and other delicate instruments, when the manufacturer recommends autoclaving at temperatures of 121C (250F). Nominal parameters default settings Sterilization temperature: 121C (250F) Sterilization time: 15 minutes Operations sequence: (PV, pre-vacuum model only) Air removal stage; four vacuum pulses remove air by drawing the chamber down to 20kPa.
Program 3: Liquid A For liquids when the manufacturer recommends autoclaving at temperatures of 121C (250F) for 15 minutes. Note: 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 ...
Program 4: Liquid B – Waste For liquids when the manufacturer recommends autoclaving at temperatures of 121C (250F) for 30 minutes, such as liquid waste. Note: both PT100 temperature sensors must be inside the bottles For proper sterilization, fill the bottles with approximately the same amount of liquid.
Program 7: Waste For waste products, when the manufacturer recommends autoclaving at temperatures of 134C (273F). Nominal parameters default settings Sterilization temperature: 134C (273F) Sterilization time: 7 minutes Drying time: 15 minutes Operations sequence: (PV, pre-vacuum model only) Air removal stage; four vacuum pulses remove air by drawing the chamber down to 20kPa.
Program 8: Hollow Load For Wrapped delicate instruments, when the manufacturer recommends autoclaving at temperatures of 121C (250F). Nominal parameters default settings Sterilization temperature: 121C (250F) Sterilization time: 15 minutes Drying time: 15 minutes Operations sequence: (PV, pre-vacuum model only) Air removal stage; four vacuum pulses removes air by drawing the chamber down to 20 kPa.
Program 9: Vacuum Test (PV, pre-vacuum model only) Vacuum is produced in the chamber down to P1=15 kPa. At this stage all the valves close. The autoclave remains in this stage for 5 minutes. This period enables the condition in the chamber to reach equilibrium.
6.10 Program 10: Bowie and Dick Test (PV, pre-vacuum model only) The Bowie & Dick test program, with fixed sterilization parameters 134ºC (273º F) and 3.5 minutes, cannot be modified by the operator or the technician. Nominal parameters default settings ...
6.11 Program 11: Bio Hazard Liquid Cooling (BH, bio-hazard models only) For liquids when the manufacturer recommends autoclaving at temperatures of 121ºC. for 45 minutes. All exhaust from the chamber before completion of the Sterilization phase are performed through the bio-hazard filter. Nominal parameters default settings ...
6.12 Program 12: Bio Hazard Liquid (BH, bio-hazard models only) For liquids when the manufacturer recommends autoclaving at temperatures of 121ºC. for 45 minutes. All exhaust from the chamber before completion of the Sterilization phase is performed through the bio-hazard filter. Nominal parameters default settings ...
6.13 Program 13: Bio Hazard (BH, bio-hazard models only) For instruments, when the manufacturer recommends autoclaving at temperatures of 134C (273F) for 30 minutes. All exhaust from the chamber before completion of the Sterilization phase are performed through the bio-hazard filter. Nominal parameters default settings ...
6.14 Program 14: Warm Up (Optional) Pre-warming the chamber at 95C (194F) (can be changed by the user) with no drying. Caution: This is not a sterilization program! Nominal parameters default settings Sterilization temperature: 95C (194F).. Sterilization time: 20 minutes. Operations sequence: ...
6.15 Program 15: Isothermal (Optional) For liquids when the manufacturer recommends autoclaving at 60C (140F) with no drying. Caution: This is not a sterilization program! For this program place the first PT100 sensor inside the bottle, and the second one leave loose inside the chamber Nominal parameters default settings ...
Screens following aborted cycles after complete sterilization stage The sterilization phase ended successfully – cycle ended and the reason of failure is displayed For example the next two scenarios: 7.2.1 Canceled by user after complete sterilization stage The cycle ended successfully, the reason for aborted cycle is displayed.
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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 The screen color changed...
CHECKING AND CHANGING PARAMETERS AND OTHER DATA The control system prevents changing programs if the door is closed. This protection is intended to avoid program changes if the autoclave is loaded. If the operator for example inserts the load into the chamber, closes the door and leaves the room and another operator/user tries to change the program, the operator/user will not be able to do this unless the door is opened and the load inside the chamber can be seen.
Entering the main menu Enter the SELECT USER screen by pressing the UP and DOWN keys simultaneously. To exit the SELECT USER screen move the cursor to Exit by pressing UP or DOWN keys and then press START/STOP key. SELECT USER screen will be displayed. Move the cursor to Admin and press START/STOP key.
To browse through the directories, use the UP or DOWN keys. When the required directory is blinking, press the START/STOP key. The required screen will be displayed. In order to exit this screen follows one of the next: Move the cursor to Exit with the UP or DOWN keys and select it by pressing the START/STOP key.
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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. Press the UP and DOWN keys simultaneously. 8.3.2 Print Rate Sterilization This subdirectory enables to change the printing rate during sterilization stage.
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8.3.3 Screen Saver This subdirectory enables the operator to set the screen saver time. The default time value is 90 minutes. It is possible to increase or decrease the time value up to a maximum of 600 minutes or down to a minimum 0 minutes. When entering the Screen Saver screen, the time will be displayed.
History This directory includes two subdirectories The following screen will be displayed when entering HISTORY directory: 1. In order to enter to the sub directories move the cursor by pressing UP or DOWN keys to the required item and press START/STOP 2.
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8.4.2 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.
2. To exit this screen, press the START/STOP key. Maintenance This directory includes four subdirectories following screen will displayed when entering MAINTENANCE directory: 1. In order to enter to the sub directories move the cursor by pressing UP or DOWN keys to the required item and press START/STOP 2.
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When entering the SET DATE AND TIME screen, the time and date are displayed. The cursor is blinking on the "second" digit. The time is displayed in the upper row in the form "HH:MM:SS". The hour range is 24 hour (i.e. from "0" to "24") The date is displayed in the lower row in the form "DD:MMM:YYYY".
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Press the UP and DOWN keys simultaneously. 8.5.3 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: Cycle errors: None Canceled By User Door is open...
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8.5.4 Print All Gain and Offset This subdirectory enables the operator to print all the gain and offset values. When pressing START/STOP key on the Print all gain and offset item the printer will print out the following: Drain Temperature G:000.0400;O:-004.0000 Chamber Temperature G:000.0400;O:-004.0000...
Advanced Options This directory includes two subdirectories The following screen will be displayed when entering ADVANCED OPTIONS directory: 1. In order to enter to the sub directories move the cursor by pressing UP or DOWN keys to the required item and press START/STOP 2.
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The time is displayed in the form “HH:MM”. The hour range is 24 hours (i.e. from "0" to "24"). Enabling the START CYCLE BY CLOCK To increase or decrease the time use the UP or DOWN keys. To move the cursor from one digit to another press the START/STOP key.
5. Remove the USB device from the USB Socket 6. In order to exit this screen and return to ADVENCED OPTIONS directory press START/STOP key. In order to exit from the ADVANCED OPTIONS directory follows one of the next: Move the cursor to EXIT with the UP or DOWN keys and select it by pressing the START/STOP key.
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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. Software Logic – Holds all the application logic for running the machine. Data Code section that handle the entire data storage in the application.
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Software DLL size Major Minor Automatic Bugs update date change change builder repair Major change Concept change eg: changing the operating system, Changed by the programmer in accordance with the change sequence. Minor change Feature change function change, changed by the programmer in accordance with...
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8.7.2 View factory default version information This subdirectory enables the operator to see the factory default version information. In order to see this subdirectory press START/STOP key on the View factory default version information item. The following screen will be displayed: Software DLL size Major...
PRINTER 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: Ster Temp: ...
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H 00:18:04 134.4 315.1 The time, temperature and pressure during heating H 00:16:35 128.9 268.4 The time, temperature and pressure during heating H 00:13:35 116.3 180.9 The time, temperature and pressure during heating A 00:08:48 089.6 077.1 The time, temperature and pressure during air removal A 00:05:48 091.3 049.4...
Printer Handling 9.2.1 Maintenance Wipe off the soiling on the printer surface with a dry soft cloth with a weak neutral detergent. After that, wipe the printer with a dry cloth. 9.2.2 Setting paper PLUS II Front view 1-Paper mouth 2-STATUS Led 3-OPEN key (for paper roll compartment opening)
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Open the printer's cover door (1) by pulling it up (see Fig. 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. Place the paper roll making sure it unrolls in the proper direction as shown (see Fig.
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9.2.3 Treating the 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. Cautions Never disassemble the printer. Failure to follow this instruction may cause overheating or burning of the printer or the AC adapter.
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.
6. Place instruments with ratchets opened and unlocked or clipped on the first ratchet position. 7. 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. 8.
OPERATING INSTRUCTIONS 11.1 Turning on the autoclave To start the system, turn on the main switch (1), located under the printer cover. The door is equipped with an electrical cylinder. This electrical cylinder performs the automatic opening and closing of the door. 11.2 Opening the door In order to open the door, follow the next steps:...
The following screen will be displayed: If the door has opened successfully, the following screen will be displayed: 11.3 Loading Load the autoclave properly according to instructions in sec. 9. PREPARATION BEFORE STERILIZATION. 11.3.1 Selecting the program 1. Select the program. ...
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11.3.2 Closing the door In order to close the door, follow the next steps: When the door is open, the screen below will be displayed: In order to close the door push the door to the wall of the autoclave chamber for at least 5 seconds as shown in the picture below: While closing the door the following screen will be displayed: Page 70 of 86 Pages...
When the door is properly closed, open door symbol replaced by the message "System Ready" and the following screen will be displayed: 11.4 Starting cycle Start the cycle by pressing the START/STOP key. If your autoclave supports CFR 21 part 11 standard, perform the following procedure: SELECT USER screen will be displayed: Enter the Enter Code screen by moving the cursor to...
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Set your password, then move the cursor to Set by pressing the START/STOP key. When Set is blinking, press the UP or DOWN keys to return to the program screen. The autoclave starts performing sequence of operations. The actual measured values of pressure and temperature are displayed continuously and printed every minute at stage, and every 5 minutes at the other stages.
11.5 Unloading 1. When the cycle ended, press START/STOP key to verify the status. Message "Cycle Ended" (and the relevant failure message, if applicable) is displayed on the screen. 2. Verify that there is no pressure in the chamber, according to the reading on the display.
11.7 Start Cycle by Clock mode This mode enables the operator to define the time of the beginning of the cycle. The maximum possible delay is 24 hours. For further information see sec. 6.8.1. “Start Cycle by Clock”. 11.8 Moving the Autoclave 1.
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11.9.1 Safety Protective equipment and clothes and other safety instructions should be implemented in accordance with local and national regulations and/or rules! For proper sterilization, do not overload the chamber. Only autoclavable products shall be used; please refer to the manufacturer instructions for sterilization of unknown materials or instruments.
DOOR SAFETY SYSTEM The door safety consists of two safety means: 12.1 Electric door locking system Door closing: the user pushes the door towards the chamber frame, a switch located on the frame indicates that the door is in locking position and switches on an electrical cylinder that closes and locks the door.
SERVICE AND MAINTENANCE 13.1 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.
Drain the generator every 6 months and refill it with mineral free water (to be done by a qualified technician). 13.1.4 Periodical Tests Once every month activate the safety valve (see sec. 12.2). 13.2 Checking the Safety Valve Both safety valves, the chamber safety valve (2) and the generator safety valve (3), are located on the top rear of the autoclave (see Rear View, 14 and 15).
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Pressure-Regulating Nut Rear Wall 13.2.2 ASME-approved type safety valve For the autoclave safety valve, operate the sterilization cycle; for the generator safety valve, operate the generator. Allow a pressure of approximately 200 kPa (29-psi) to build up in the chamber. Operate the safety valve by pulling the ring of the safety valve using a tool, i.e.
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. Message / Symbol / Failure Description...
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'Water in This icon usually appears when a Chamber' BH (bio-hazard) cycle is failed. symbol is You cannot open the door when Wait for the cycle to end, displayed in the there is water in chamber. then perform a new end of a failed cycle..
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This message is displayed if the High Pressure system cannot reach preset pressure Perform a new cycle. (Exhaust) within 10 minutes from the beginning of the exhaust stage. This message is displayed if the system cannot reach the required Pressure Time Verify that the autoclave is pressure conditions in the chamber, Error...
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Supply water This message is displayed in case Check and fix the city (tap) error (digitat of a city (tap) water supply water supply. input option) malfunction. Compressed This message is displayed in case air supply error of a compressed air supply Check and fix the air supply.
BASKETS AND CONTAINERS Container for waste products Basket Stainless steel container Stainless steel wire baskets for waste products L x D x H (mm) Capacity L x D x H (mm) Capacity 680 x 260 x 225 680 x 260 x 225 Page 85 of 86 Pages...
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