Anprolene AN 74i and AN74ix Owners Manual

OWNER’S MANUAL

Owner’s Manual

Congratulations on your purchase of an AN74i / AN74ix Anprolene® Sterilizer. For over 30 years, Andersen Products has been a leader in tabletop Ethylene Oxide sterilization. With the installation of your sterilizer, you join thousands of healthcare facilities worldwide using an Andersen Products’ sterilization system. Please read the entire Owner’s Manual prior to installing and using your new machine. The Andersen Anprolene sterilizer uses less than 20% of the amount of Ethylene Oxide gas of our nearest competitor (less than 18 grams). However, please note that Ethylene Oxide can be hazardous if not properly handled. Ethylene Oxide is also highly flammable, so precautions should be taken to avoid improper installation or operation of the equipment near spark or open flame.

Knowing how to properly use the Anprolene system is important. With this in mind, we have included the Operator Training and Education Section found in Section 4, beginning on page 17. Illustrated instructions and information on humidification are included in the training section. In addition, you will also find information concerning the Andersen Key Operator Certification Program. The Key Operator Program covers all aspects of effective use of your Anprolene sterilizer and is offered free of charge for the lifetime of the sterilizer. After reviewing the enclosed training material, please call 800-523-1276 or 336-376-3000 to schedule your exam. Outside the United States and Canada, please contact your local distributor. A list of suggested items that can be sterilized in the Anprolene sterilizer can be found on pages 28 and 29 of this manual. CAUTION: Food and drugs may not be sterilized because Ethylene Oxide may change their chemical composition. If you are not certain about an item’s suitability for Ethylene Oxide sterilization, please contact an Andersen Customer Service Representative. Section 6 of this manual covers Troubleshooting and Error Messages and begins on page 34. Installation requirements and instructions are discussed in Appendices B through D, beginning on page 46. Please call Customer Service at 800-523-1276 or 336-376-3000 for repair services. Outside the United States and Canada, please contact your local distributor. Instructions on preparation of products prior to sterilization appear in Section 1, beginning on page 5. Accessories for use with your Anprolene sterilizer can be found in Section 5, beginning on page 30. WARNING! If the Anprolene sterilizer is not installed and operated in the manner specified by Andersen Products, the protection provided by the equipment may be seriously impaired. DANGER! Ethylene Oxide is a Cancer and Reproductive hazard. Refer to MSDS on page 68 and EPA approved labeling on all Anprolene refill kits for complete instructions and warnings. In case of emergency, please call Andersen Products Customer Service at 336-376-3000 during regular business hours (EST). After business hours, please contact 800-255-3924. 2

OWNER’S MANUAL

Overview of Features Top Cabinet

Back Lighted Liquid Crystal Display

On/Off switch Program Selection Switches Door Support

Door Sensor

Quick Disconnect Purge Tube Assembly

Velcro® strap

Latching Door Lock

Cooling Fan Guard and Removable Filter

Fuse Drawer

Replacement Fuse Specifications

3/4” (1.91 cm) I.D. Exhaust Tubing Stainless Steel Hose Clamp Rear 3/4” I.D. Bulkhead Exhaust Fitting & 90 Deg Elbow Underwriters Laboratories’ Approval Label

Electrical Connection Requirements

Detachable Grounded Power Cord

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OWNER’S MANUAL

TABLE OF CONTENTS Introduction ...2 Overview of Features...3 Section 1 - Before You Begin...5 Section 2 - Diagrammatic Instructions for Normal Operation ...8 Section 3 - Detailed Pictorial Instructions for Running the Sterilization Cycle...12 Section 4 - Operator Training and Education...17 Section 5 - Accessories for Use with Anprolene...30 Section 6 - Warnings, Troubleshooting, Error Messages and Alarms ...34 Section 7 - Maintenance ... 42 Appendices A - Technical Features...44 B - Installation Requirements ...46 C - Installation Instructions for New Anprolene Users ...49 D - Installation Instructions for Current Anprolene Users ...55 E - Flow Chart for Normal Operating Screen...59 F - Material Safety Data Sheets...68 G - AN74 i/ix Specifications ...74 H - Equipment Ratings Summary and Replacement Parts List...77 I - Andersen One Year Limited Warranty...80 J - Useful Life of Sterilizer is Ten Years...83

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SECTION 1 Before You Begin...

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OWNER’S MANUAL

SECTION 1 Before You Begin There are a number of conditions that can affect the operation of your sterilizer. By paying close attention to these details, you will greatly reduce the likelihood of problems. 1.1.

Installation: Please make sure that your Anprolene sterilizer is installed correctly. Full installation instructions can be found in Appendix B, starting on page 46. Please call our Customer Service Department if you have installation questions not covered in this section.

1.2.

Environmental Factors: Your Anprolene sterilizer is designed to operate at room temperature (68°F/20°C to 91°F/33°C ). Please pay close attention to the following factors: a. Temperature: Ethylene Oxide (EtO) is sensitive to temperature and becomes less effective at lower temperatures. Make sure that the room where the sterilizer is installed maintains a temperature between 68°F/20°C and 91°F/33°C for the full duration of the sterilization cycle. b. Humidity: Anprolene sterilization requires at least 35% relative humidity (RH). In low humidity areas, or during the winter months when the humidity level drops, an Andersen Humidichip® may be necessary to achieve and/or maintain the proper humidity level in the sterilization liner bag. Please refer to Section 4, beginning on page 17, for more information on humidity and pre-humidification.

1.3.

Preparing Items for Sterilization: Materials to be sterilized by all Ethylene Oxide sterilizers, including Anprolene, must be meticulously cleaned and dried. Coatings of dried proteins such as pus, blood or feces protect microorganisms and slow the sterilization process. Precautions must always be taken before sterilization with Anprolene. To prepare items for sterilization, please include the following steps: a. Disassemble - Anprolene is a highly diffusible gas sterilant; nevertheless, occlusive caps, plugs and stylets must be removed from instruments so that the gas can penetrate freely. Hollow bore needles and plastic or rubber tubing must be open and free from stylets and plugs. Syringes must be packaged with the plungers removed. b. Wash - Scrub the disassembled instruments in detergent and water to the most critical standard of cleanliness possible. We recommend the use of an enzymatic cleaner such as Andersen Products’ AN2281 Surgical Instrument Enzymatic Detergent, which may be used with most materials. c. Dry - Water on instruments at the time of exposure to Anprolene may react with the gas and reduce its effectiveness. Make sure that items to be sterilized are physically dry before wrapping and processing. Towel drying or drain drying is sufficient. CAUTION: Do not use hot air to dry. d. Wrap - All items to be sterilized must be wrapped in cloth, paper or plastic in the manner conventional for steam sterilization, or in Andersen Seal and Peel® Packaging. 6

OWNER’S MANUAL

SECTION 1 Before You Begin There are a number of conditions that can affect the operation of your sterilizer. By paying close attention to these details, you will greatly reduce the likelihood of problems. 1.1.

Installation: Please make sure that your Anprolene sterilizer is installed correctly. Full installation instructions can be found in Appendix B, starting on page 46. Please call our Customer Service Department if you have installation questions not covered in this section.

1.2.

Environmental Factors: Your Anprolene sterilizer is designed to operate at room temperature (68°F/20°C to 91°F/33°C ). Please pay close attention to the following factors: a. Temperature: Ethylene Oxide (EtO) is sensitive to temperature and becomes less effective at lower temperatures. Make sure that the room where the sterilizer is installed maintains a temperature between 68°F/20°C and 91°F/33°C for the full duration of the sterilization cycle. b. Humidity: Anprolene sterilization requires at least 35% relative humidity (RH). In low humidity areas, or during the winter months when the humidity level drops, an Andersen Humidichip® may be necessary to achieve and/or maintain the proper humidity level in the sterilization liner bag. Please refer to Section 4, beginning on page 17, for more information on humidity and pre-humidification.

1.3.

Preparing Items for Sterilization: Materials to be sterilized by all Ethylene Oxide sterilizers, including Anprolene, must be meticulously cleaned and dried. Coatings of dried proteins such as pus, blood or feces protect microorganisms and slow the sterilization process. Precautions must always be taken before sterilization with Anprolene. To prepare items for sterilization, please include the following steps: a. Disassemble - Anprolene is a highly diffusible gas sterilant; nevertheless, occlusive caps, plugs and stylets must be removed from instruments so that the gas can penetrate freely. Hollow bore needles and plastic or rubber tubing must be open and free from stylets and plugs. Syringes must be packaged with the plungers removed. b. Wash - Scrub the disassembled instruments in detergent and water to the most critical standard of cleanliness possible. We recommend the use of an enzymatic cleaner such as Andersen Products’ AN2281 Surgical Instrument Enzymatic Detergent, which may be used with most materials. c. Dry - Water on instruments at the time of exposure to Anprolene may react with the gas and reduce its effectiveness. Make sure that items to be sterilized are physically dry before wrapping and processing. Towel drying or drain drying is sufficient. CAUTION: Do not use hot air to dry. d. Wrap - All items to be sterilized must be wrapped in cloth, paper or plastic in the manner conventional for steam sterilization, or in Andersen Seal and Peel® Packaging. 7

OWNER’S MANUAL

SECTION 2 Diagrammatic Instructions for Normal Operation

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OWNER’S MANUAL

SECTION 2 Diagrammatic Instructions for Normal Operation

Turn on the sterilizer by pressing the on-off switch on the back right side of the top cabinet.

AN74 I ANPROLENE STERILIZER

The Liquid Crystal Display will illuminate. The initial startup and standby screen is shown to the right.

START When START is pressed

To load the sterilizer and commence a sterilization cycle, press the button immediately to the right of the word START. If an abator is attached to the machine, the number of cycles remaining for the abator cartridge will be displayed. A new abator cartridge may be used for a maximum of 250 sterilization cycles. The display will indicate that the sterilizer has performed a self test on the cabinet ventilation pump and ventilation switch. The version of the computer software is shown (VER 4.04). In addition, the total number of hours that the ventilation pump has been operating is shown (35 PUMP HOURS). This information is used to determine when preventive maintenance should be performed. (See Section 7). The cooling fan blade speed is displayed as a percentage of nominal operating speed (FAN 97% RPM).

Once the self test of the cabinet ventilation pump has been successfully completed, the display will show the instructions for loading the sterilizer. After the sterilization bag has been secured to the purge tube bobbin via the Velcro strap, press the button to the right of the word PURGE to evacuate air from the sterilization bag. The display will show the initial 1 minute, 30 second initial purge is in progress. To stop the cycle and return to the standby screen, press the button to the left of the word EXIT.

250 ABATOR CYCLES REMAINING

SELF TEST VER 4.04 35 PUMP HOURS FAN 97 % RPM

SELF TEST OK 35 PUMP HOURS FAN 97 % RPM

LOAD STERILIZER BAG CLOSE BAG OVER TUBE PURGE BAG EXIT PURGE When PURGE pressed INITIAL PURGE 00:01:30 REMAINING EXIT

Continued on next page

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OWNER’S MANUAL

Diagrammatic Instructions for Normal Operation, continued Continued from previous page

After the initial purge, the screen to the right will appear. If the operator breaks the ampoule and closes the door without selecting a cycle length, the sterilizer will beep after 5 seconds to remind the operator to select the appropriate cycle length. The operator should break the Anprolene ampoule, close the sterilizer door, remove the key, and select the desired cycle length.

Once the sterilization cycle has been initiated, the display will show the cycle length chosen and the time remaining in the sterilization cycle.

BREAK AMPOULE CLOSE & LOCK DOOR SELECT CYCLE LENGTH 24 HOUR 12 HOUR When 12 hour cycle length selected 12 HOUR CYCLE STERILIZING 11:24:15 REMAINING

12 HOUR CYCLE STERILIZING 11:24:15 REMAINING

At the end of the sterilization cycle, the unit will begin a 2 hour sterilization liner bag ventilation (purge) cycle to remove the residual Ethylene Oxide. The display will show the time remaining in the purge cycle. During this time the purge pump and cabinet ventilation pumps will run alternating two minute cycles. At the end of the 2 hour liner bag ventilation (purge) cycle, the machine will beep once and instruct the user to UNLOAD STERILIZER, signifying the end of the cycle. The sterilizer may now be safely unloaded. Note - Additional Aeration Option: The ventilation pump and purge pump continue running alternating two minute cycles until the door is opened and the EXIT button is pressed. If needed, items may be left in the machine for further aeration after the cycle has ended by simply leaving the items inside the sterilizer. The count-up timer indicates the additional aeration time. Once the cycle has been concluded by opening the door and pressing the EXIT button, both pumps will stop running and the sterilizer will return to the standby screen.

VENTILATING BAG 01:59:55 REMAINING

UNLOAD STERILIZER 00:08:54 EXIT

UNLOAD STERILIZER 01:29:30 EXIT When EXIT pressed AN74 I ANPROLENE STERILIZER START 10

OWNER’S MANUAL

Diagrammatic Abator Instructions: Installing Optional New Abator Cartridge, Resetting Counter

When the Abator cartridge has been used completely (250 sterilization cycles), the screen will display ABATOR CARTRIDGE EXPIRED and the alarm will sound. Additional cycles may be completed by bypassing the screen. This is not recommended. The cartridge should be changed prior to starting a new cycle.

2. Press ABATOR button

EXIT

BYPASS

AN74 I ANPROLENE STERILIZER

Once a new cartridge is installed, the counter must be reset. To reset the counter: 1. Hold the left button continuously for more than 3 seconds

ABATOR CARTRIDGE EXPIRED

PARAMETERS When left button pressed and held for more than 3 seconds.

START

DIAGNOSTICS ABATOR ATTACHED

PRESS ABATOR TO INSTALL CARTRIDGE, OTHERWISE PRESS DIAG ABATOR DIAG

INSTALL NEW ABATOR CARTRIDGE 3. Answer YES to the question: INSTALL NEW ABATOR CARTRIDGE

NO

YES

CARTRIDGE COUNTER RESET TO 250

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OWNER’S MANUAL

SECTION 3 Detailed Pictorial Instructions for Running a Sterilization Cycle

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SECTION 3 Detailed Pictorial Instructions for Running the Sterilization Cycle Once the items to be sterilized have been disassembled, cleaned, dried and wrapped, the sterilization cycle can proceed. 3.1 Prior to loading the sterilizer: (1) Turn the power ON by pressing the right side of the black power switch located on the back right corner of the machine. This will cause the initial screen to appear. (2) Press the button to the right of START on the display screen to initiate the self test.

AN74 I ANPROLENE STERILIZER START

Upon successful completion of the self test, the following LOAD screen will be displayed: LOAD STERILIZER BAG CLOSE BAG OVER TUBE PURGE BAG EXIT PURGE

3.2. Preparation and loading of the sterilization liner bag: a. Remove a sterilization liner bag from the refill kit and place it inside the sterilizer cabinet with the open end facing you. b. Place the wrapped items for sterilization inside of the sterilization liner bag. c. Unroll the gas release bag containing the gas ampoule. d. Without opening the gas release bag, gently move the ampoule to the center of the gas release bag. e. Place the gas release bag on top of the wrapped items so that you can easily manipulate it through the wall of the bag after the sterilization liner bag has been closed. Do not break the ampoule at this time. f. Place appropriate indicators inside of the sterilization liner bag. (See Section 5 for more information concerning sterility indicators.)

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OWNER’S MANUAL

PURGE TUBE ASSEMBLY Quick Release Connector (Female end)

Purge tube, this end is connected to upper cabinet.

Quick Release Connector (Male end)

End Goes Into Liner Bag

One-way Check valve

Neck. Wrap the sterilization bag around aluminum bobbin and secure with the Velcro strap

3.3. Insert the purge tube into the sterilization liner bag with the plastic ball towards the rear of the bag and the neck towards the opening. Then, gather the open end of the sterilization liner bag around the aluminum neck of the purge tube, taking care to ensure you have left no openings.

3.4. Slip the black Velcro® strap around the outside of the sterilization liner bag and thread the pointed end of the strap through the square black loop. Pull the Velcro strap firmly and then wind it back around the exposed surface of the strap. Make sure that the Velcro strap is secure and provides an airtight seal between the aluminum neck of the purge tube and sterilization liner bag. 3.4.a. This is how the secured sterilization liner bag and purge tube should appear. 3.5. If the purge tube has been disconnected from the sterilizer by means of the quick release, simply reattach it by pressing the male and female ends together until they click. 3.6. With the cabinet door open, press the PURGE button. LOAD STERILIZER BAG CLOSE BAG OVER TUBE PURGE BAG EXIT PURGE

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OWNER’S MANUAL

INITIAL PURGE 00:01:30 REMAINING EXIT

3.8. After the initial purge has been completed (timer to 00:00:00), the display instructs the operator to: (1) break the ampoule by manipulating the ampoule gas release bag through the wall of the sterilization liner bag, (2) close the door, and (3) lock the door and remove the key. 3.9. Select the length of the sterilization cycle. For most items, the 12 HOUR cycle will be adequate. BREAK AMPOULE CLOSE & LOCK DOOR SELECT CYCLE LENGTH 24 HOUR 12 HOUR

3.10. When sterilizing lengths of tubing greater than 3 feet (91.5 cm) or loads containing gas absorbent materials, the extended length 24 hour cycle should be used. Large volumes of gas absorbent materials (rubber and plastic) also require the use of an additional Anprolene ampoule and the extended 24 hour cycle. To operate the sterilizer using the extended 24 hour cycle, press the button to the left of 24 HOUR. The display will then show STERILIZING 24:00:00 REMAINING. 24 HOUR CYCLE STERILIZING 24:00:00 REMAINING

3.11. The sterilization cycle will then begin. Note: After the ampoule is activated and the door is closed, if the operator does not select a cycle length within 5 seconds, a continuous alarm will sound to remind the operator to select the appropriate cycle time. 12 HOUR CYCLE STERILIZING 11:24:15 REMAINING

3.12. At the end of the 12 (or 24) hour cycle, the cabinet ventilation pump will stop and the purge pump will run for two minutes, flushing Ethylene Oxide from the sterilization liner bag. Then the purge pump will stop while the cabinet ventilation pump runs for two minutes. This alternating cycling of the purge and cabinet ventilation pumps will continue for a period of two hours. This will be displayed as shown below and will count down to 00:00:00. VENTILATING BAG 01:59:59 REMAINING

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3.13. At the end of the two hour ventilation cycle, the following screen will appear, notifying the operator that the sterilizer may be unloaded. UNLOAD STERILIZER EXIT

3.14. If the operator does not unload the sterilization liner bag at the end of the two hour ventilation cycle, the purge pump and the cabinet ventilation pump continue to alternate on a two minute cycle to flush the sterilization liner bag and cabinet indefinitely until the door is opened and the EXIT button is pressed This feature may be used for Additional Aeration. Refer to page 45. UNLOAD STERILIZER EXIT

3.15. If the operator opens the door after the two hour purge cycle is complete and presses EXIT , both pumps will stop and the program will automatically return the sterilizer to the start screen. AN74 I ANPROLENE STERILIZER START

3.16. To unload the sterilizer, open the door and remove the Velcro® strap from around the neck of the purge tube. Remove the purge tube from the sterilization liner bag. Unload the wrapped items from the sterilization liner bag and place them on a shelf in a well-ventilated room that has a minimum of 10 air changes per hour of fresh makeup air. 3.17. Gas absorbent materials such as rubber or plastic must be aerated in their individual packages for at least 24 additional hours before they are used. 3.18. The used gas release bag ampoule and sterilization liner bag may be disposed of in ordinary rubbish. Never reuse sterilization liner bags.

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SECTION 4 Operator Training and Education

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OWNER’S MANUAL

SECTION 4 Operator Training and Education

♦

Ethylene Oxide sterilization procedures must be supervised by personnel trained and well informed in the safe use of such sterilant materials.

♦

Personnel working with ethylene oxide must have had comprehensive instruction in the process. This instruction must cover the relevant health hazards (See MSDS on page 68), relevant national regulations (e.g. OSHA regulation 29 CFR Part No. 1910 Standard No. 1910.1047), methods for safe use and methods to detect escape of sterilant material (e.g. AN 93 Airscan Badges)

♦

Regular in-service programs relating to the process must be conducted and an attendance record and evidence of understanding must be kept for each employee (e.g. Andersen Key Operators Test).

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OWNER’S MANUAL

4.1 4.2 4.3

Humidity and Pre-humidification Abridged Illustrated Instructions Key Operator Study Guide

4.1. Humidity and Pre-humidification. It has been demonstrated repeatedly that some microorganisms are made very resistant to Ethylene Oxide sterilization systems by desiccation, which is exposure to very low relative humidity. As a result, humidity is a very important part of the Ethylene Oxide sterilization cycle. Items that can be washed in water and towel or air dried will not need pre-humidification. Items that may be damaged by immersion in water or a sterilization load that contains a large amount of material that will absorb water (dry paper and cloth) will need pre-humidification. Process for Pre-Humidification Using an Anprolene Sterilization Liner Bag a. Items that cannot be immersed in water should be disassembled and wrapped in the usual way. b. Place the prepared items along with a Humidichip® inside a sterilization liner bag. Using a twist tie or Velcro® strap, securely close the neck of the bag. c. Leave the items in the bag for a minimum of four hours at a temperature of 68°F /20°C or higher. Pre-humidification may take place outside the sterilizer cabinet. Take caution not to rip or puncture the sterilization liner bag. During the sterilization cycle, use a Humidichip to ensure a minimum of 35% Relative Humidity inside the sterilization liner bag. Items that did not need pre-humidification can be added to the sterilization liner bag, along with the appropriate controls such as Dosimeter®, Steritest®, or other Biological Indicators. If there is any question as to the integrity of the sterilization liner bag, use a new liner bag for the sterilization cycle.

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OWNER’S MANUAL

4.2 ABRIDGED ILLUSTRATED INSTRUCTIONS

HOW ANPROLENE WORKS

1. The glass ampoule contains liquid Ethylene Oxide (EtO) and an inert solid stabilizer. The ampoule is scored at the neck for easy opening.

2. A plastic/fabric break shield surrounds the ampoule. The ampoule and shield are sealed inside a plastic gasrelease bag, which should never be opened. IMPORTANT! Push the ampoule to the center of the gas release bag before activating

3. After the gas release bag is placed inside of the sterilization liner bag and it is secured to the purge bobbin, the sterilization bag is then vacuumed down. To release pure EtO gas, manually snap off the top of the ampoule by manipulating it through the walls of the sterilization liner bag. The plastic/fabric shield prevents the broken glass of the opened ampoule from puncturing the gas-release bag.

4. The liquid EtO then boils, releasing 100% EtO gas within the gas-release bag, leaving residual deposits of the previously dissolved inert solid stabilizer.

5. Since the walls of the gas-release bag are permeable only to EtO gas and not the inert solid stabilizer, only the 100% pure EtO gas diffuses through the walls of the gas-release bag and into the liner bag.

6. EtO possesses great kinetic energy, which causes the gas molecules to spread out to every cubic centimeter of the liner bag by their own velocity.

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