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ETHYLENE OXIDE 
STERILIZATION SYSTEM 


P/N7400 041105 

5/25/2005 11:38 AM # 

AN2ooomanuaio7 , 603b g f Andersen Sterilizers, Inc. Health Science Park Haw River, NC 27258-8710 

V___ 


CERTIFIED 
ISO 9 001 



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[OWNER’S MANUAL | 


/SCfl 74i/m 7^/jc/A nprolene 

• ' Jfls sterilization 


Owner’s Manual 

Congratulations on your purchase of an AN74/ / AN74zx An¬ 
prolene® 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 sys¬ 
tem. 

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 haz¬ 
ardous if not properly handled. Ethylene Oxide is also highly 
flammable, so precautions should be taken to avoid improper in¬ 
stallation 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 steriliza¬ 
tion, 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. 



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Overview of Features 


Top Cabinet 


Program Selection 
Switches 


Door Sensor 



Back Lighted 
Liquid Crystal Display 


On/Off switch 


Door Support 


Quick Disconnect 


Purge Tube 
Assembly 



Latching Door Lock 


Velcro® strap 


Cooling Fan Guard 
and 

Removable Filter 


Fuse Drawer 


Replacement 

Fuse 

Specifications 


Detachable 
Grounded 
Power Cord 





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 Labora¬ 
tories’ Approval Label 


Electrical 

Connection 

Requirements 


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TABLE OF CONTENTS 

o 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 

o 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 ... 









[OWNER’S MANUAL | 


SECTION 1 
Before You Begin 


AM] 74i/m 74/jc/Anprolene 

• ' Jfls sterilization 


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 cor¬ 
rectly. 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 steril¬ 
ized 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. 


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[OWNER’S MANUAL | 


SECTION 1 
Before You Begin 


AM] 74i/m 74/jc/Anprolene 

• ' Jfls sterilization 


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 cor¬ 
rectly. 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 steril¬ 
ized 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. 


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SECTION 2 

V_ ) 

Diagrammatic Instructions 
for Normal Operation 


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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. 

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

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 dis¬ 
played. 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 infor¬ 
mation is used to determine when preventive mainte¬ 
nance 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 sterili¬ 
zation 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 re¬ 
turn to the standby screen, press the button to the left 
of the word EXIT. 



/ 

/ 



Continued on next page 


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Diagrammatic Instructions for Normal Operation, continued 


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 appro¬ 
priate cycle length. The operator should break the An¬ 
prolene 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. 


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 run¬ 
ning and the sterilizer will return to the standby screen. 


Continued from previous page 



1 


BREAK AMPOULE 
CLOSE & LOCK DOOR 
SELECT CYCLE LENGTH 
24 HOUR 12 HOUR 



When 12 hour cycle length / 

selected / 





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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. 



ABATOR CARTRIDGE 
EXPIRED 

EXIT BYPASS 



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 


2. Press ABATOR button 


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



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SECTION 3 

V_ ) 

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 ster¬ 
ilization 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 comer 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. 


AN74I 

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 steriliza¬ 
tion 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 am¬ 
poule at this time. 

f. Place appropriate indicators inside of the sterilization liner bag. 
(See Section 5 for more information concerning sterility indica¬ 
tors.) 


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[OWNER’S MANUAL] 



PURGE TUBE ASSEMBLY 


Quick Release 
Connector 
(Female end) 


Quick Release 
Connector 
(Male end) 


Purge tube, 
this end is 
connected to 



One-way Check valve 


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 ex¬ 
posed 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. 

With the cabinet door open, press the PURGE button. 



LOAD STERILIZER BAG 
CLOSE BAG OVER TUBE 
PURGE BAG 

EXIT PURGE 


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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. 



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. 


AN74I 

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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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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4.1 Humidity and Pre-humidification 

4.2 Abridged Illustrated Instructions 

4.3 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 Hu¬ 
midity 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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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. 




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 punctur¬ 
ing the gas-release bag. 



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. 



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



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. 



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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4.2 ABRIDGED ILLUSTRATED INSTRUCTIONS 


HOW ANPROLENE WORKS 



7. EtO gas readily passes through cloth, paper, and Seal 8. The walls of the sterilization bag are also porous to EtO 

and Peel® Packaging to reach the items to be sterilized. § as - As concentration of EtO gas in the liner bag is 

increased by gas diffusing from the gas-release bag, the EtO 
molecules also diffuse through the walls of the liner bag and 
into the sterilization cabinet. 



9. The EtO molecules diffusing from the liner bag into the 
sterilization cabinet are then evacuated to the abator, if installed. 
Any remaining effluent is then vented to the outside atmosphere 
by the sterilizer’s ventilation system. 



11. At 12 hours, all items are sterile, and the residual gas in the 
liner bag is small. The additional two-hour purge cycle is used 
to remove remaining residual EtO from the liner bag before the 
container may be opened. 


10. For about three hours there are more EtO molecules 
released into the liner bag than are released by the liner bag 
into the sterilizer. Then the rates are similar for three hours. 
Finally, the liquid Anprolene in the gas-release bag is 
exhausted. EtO molecules gradually diffuse into the sterilizer 
for the remainder of the cycle. 



12. Gas-absorbent materials, like plastic and rubber, are 
aired in their protective wrapping before use. The EtO 
gas absorbed by plastic or rubber readily escapes through 
cloth, paper, or Seal and Peel® Packaging. 


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4.3 Key Operator Study Guide: 
AN74I / IX Anprolene® Sterilizer 


Thank you for using the Anprolene® sterilization system. 

The active ingredient in Anprolene is ethylene oxide (EtO or EO), a chemical that can be hazardous 
if not handled properly. To ensure that you fully understand the safe operation of your sterilizer, we 
strongly encourage you to take advantage of our Key Operator certification program. 

To begin Key Operator training, please read through this study guide thoroughly. If you do not 
understand any of the information in the guide, please call Andersen Customer Service for 
assistance. Once you are familiar with the study guide, you can call us at (800) 523-1276 to 
schedule a test. 

The test will take approximately 20 minutes. The Key Operator test is also an excellent opportunity 
to ask your Andersen Representative any questions you may have about your Anprolene system or 
ethylene oxide. 

When you successfully complete the test, you will receive a certificate and a registered key ring. 
We look forward to hearing from you. 

Key Operator training is free of charge for the lifetime of your sterilizer. Please have all new 
operators of your Anprolene sterilizer contact us for training before they use the system. 


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A. Environmental Considerations 


1) Temperature 

. Store your Anprolene gas refill kits in a cool, secure area. We recommend storage 
below 72°F (22.2°C). 

. The sterilizer must be used in an area where the temperature is not less than 68°F 
(20°C) or more than 91°F (33°C). This temperature range must be maintained 
during the entire sterilization cycle. 

EO FACTS: At sea level, ethylene oxide is a liquid below 51 °F (10.6. ° C). 

Above 51 ° F, EO begins to boil and converts into a gas. EO does not become an 
effective sterilant until 68 °F (20 ° C) Make sure that the room where your 
Anprolene sterilizer is installed remains above 68 °F during the entire 12-hour 
sterilization cycle. This is especially important during the winter months! 

2) Humidity 

. Humidity is very important to the Anprolene process. Relative Humidity (RH) must 
be at least 35% in the room where item preparation and sterilization take place. 
Spores that might be on the instruments may become very dry and resistant to 
Anprolene if the RH is below 35%. 

. The simplest way to humidify items is to wash them. 

. It is necessary to humidify items which cannot be washed by enclosing them in a 
plastic bag with an Andersen Humidichip® or a damp sponge for four hours prior to 
sterilization at a temperature greater than 68 0 F (20 0 C) 

B. Preparing Items for Sterilization 

Four basic steps must always be followed when preparing items for sterilization: 

1) Disassemble 

2) Wash 

3) Dry 

4) Wrap 

1) Disassemble 

Items containing removable parts, such as syringes, must be taken apart before wash¬ 
ing, drying, and wrapping them to allow the Anprolene an unobstructed path. 

WARNING!: Instruments which contain batteries should be taken apart and the 
batteries removed and wrapped separately to protect against a spark occurring and 
igniting the ethylene oxide gas. 

2) Wash 


Items must be washed surgically clean prior to sterilization. For cleaning, we recom¬ 
mend using an enzymatic detergent such as Andersen’s Sterizyme (AN2281). 


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3) Dry 

Two accepted ways to dry any item prior to sterilization with Anprolene are: 

1. Towel drying 

2. Drain drying (air drying). 

WARNING!: Heat or hot air should never be used to dry an item prior to steriliz¬ 
ing it with Anprolene because it will dehydrate or dry out bacteria spores making 
them more resistant to the ethylene oxide gas. 

WARNING!: Any water left on items may react with ethylene oxide, reducing its 
efficacy. Please air dry instruments thoroughly. 

4) Wrap 

The following types of wrapping material are recommended for use with Anprolene: 

1. Andersen Seal and Peel® Packaging (which is airtight and waterproof and greatly 
extends the shelf life when heat sealed at both ends) 

2. Cloth (like CSR wrap) has an estimated sterile shelf life of 30 days 

3. Paper (self-seal pouches) has a shelf life of 30 days 

4. Tyvek-paper pouches 

©HINT: Exposure indicators such as the Andersen AN85 or AN86 will turn color in 
the presence of EO, helping to later identify items that have been sterilized. 

C. Sterilization Cycle 

1) Preparing the Sterilization Liner Bag 

1. Place prepared items in a new sterilization liner bag. 

WARNING!: Do not reuse sterilization liner bags. Even a tiny pinhole in a sterili¬ 
zation liner bag can allow gas to escape and cause cycle failure! 

WARNING!: Do not sterilize liquids, foods or drugs in the Anprolene sterilizer. If 
you have any questions about whether an item may be sterilized using Anprolene, 
please call Andersen Customer Service. 

2. Insert appropriate controls such as a Dosimeter (chemical indicator) or a Steritest® 
(biological & chemical indicator) into the least accessible part of the sterilization 
liner bag. Add a Humidichip® if appropriate. 

3. Unroll the gas release bag containing the gas ampoule and, without opening it, gently 
move the ampoule to the center of the gas release bag. Place it on top of the items in 
the sterilization liner bag where it will be easy to break. 


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4. Insert the purge tube into the sterilization liner bag with the aluminum bobbin and 
quick release fitting at the open end. Place the black Velcro® strap around the 
sterilization liner bag and the bobbin of the purge tube, and pull it snug though its 
loop to close the sterilization liner bag. The strap must secure the sterilization liner 
bag tightly around the aluminum bobbin to keep gas from escaping. 

5. Connect the quick release connector to the purge tube, if it is not already connected. 

©HINT: The sterilization liner bag may be loaded and sealed away from the steri¬ 
lizer cabinet, and connected to the purge tube once you are ready to start a cycle. 

2) Starting the Cycle 

1. Make sure the AN 74 i/ix power cord is connected. Press the right side of the power 
switch located on the right rear of the cabinet. Wait to see the ‘AN 741 
ANPROLENE STERILIZER’ and the ‘START’ message to appear on the cabinet 
display. 

2. Push the button to the right of START. 

3. Wait for the SELF TEST and number of elapsed PUMP HOURS to appear. (If above 
18,000 hours, call Andersen for service.) 

4. Press the button to the right of the PURGE message on the display and wait for the 
time to count down from 1 minute 30 seconds to ‘00:00:00’. The sterilization liner 
bag should compress as excess air is removed. 

5. When the display indicates “BREAK AMPOULE,” carefully, so as not to puncture 
the sterilization liner bag, grasp the ampoule through the sterilization liner bag and 
activate it by snapping off the top. 

3) Selecting Cycle Length 

1. Close the door. 

2. Lock the sterilizer and remove the key. 

3. SELECT CYCLE LENGTH. (Right button = 12 Hour, Left button = 24 Hour) 

WARNING: The usual Anprolene sterilization cycle is 12 hours, plus a 2-hour 
purge cycle. When sterilizing lengths of tubing 3 feet (91.4 cm) or longer, or a full 
load of gas absorbent items, it may be necessary to increase the cycle time to 24 
hours with the ‘24 HOUR CYCLE’ button and to use two ampoules. 

4. If an electronic beep sounds, it is an alert that 5 seconds have elapsed and the 
AN 74 i/ix is awaiting a 12/24 hour cycle time selection. 

5. Log sterilization data if required. 

WARNING: Never interrupt a cycle once the gas ampoule has been activated. An 
alarm will sound if the door is opened during the cycle. 


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4) Unloading the Sterilizer and Determining Sterility 

1. Remove the sterilized items only after the sterilization cycle and 2-hour purge cycle 
have been completed and the display indicates UNLOAD STERILIZER. The 
sterilizer will continue to aerate items that are not removed immediately. A count-up 
timer on the display will indicate the time that has lapsed since the final 2-hour purge 
cycle ended. 

©HINT: To unload the sterilization liner bag away from the sterilizer, simply de¬ 
tach the purge probe hose from the bag using the quick release fitting at the base of 
the purge probe. 

2. Close the sterilizer door and press EXIT to turn off the AN 74 i/ix. 

3. Unload the liner bag and check the sterility (chemical &/or biological) indicators. 

• Steritest provides an immediate indication of the success of the cycle (via the 
Dosimeter), and later proves sterility by showing that active spores have been 
killed. (Spores will require at least 48 hours of incubation to provide results.) 

• The Dosimeter shows whether time, temperature and gas concentration 
parameters have been met. It provides an immediate chemical indication that the 
cycle was successful. Dosimeters should not be used in place of biological 
indicators to prove sterility. 

• Chemical exposure indicators, such as the AN85 or AN86, do not prove 
sterilization. They only change color to show that the items have been exposed to 
ethylene oxide. 

4. Spent ampoule may be disposed of in regular trash. 

©HINT : While you may not reuse sterilization liner bags, they make great heavy- 
duty trash bags! 

D. Aeration 

• The cabinet ventilator should be running during the entire sterilization cycle to 
prevent personnel from being exposed to more than the OSHA permitted levels of 
ethylene oxide. [1.0 ppm (parts per million) over an 8 hour time weighted average 
(TWA)] Do not remove items before the full 2-hour purge cycle. Aeration should 
take place in a well-ventilated area that provides at least 10 fresh air exchanges 
per hour so that high concentrations of gas will not build up while aerating. The 
purge cycle is designed to aerate most products sufficiently to meet the short-term 
exposure level (STEL) of 5.0 ppm for the 15-minutes (while unloading the liner 
bag). 

• Metal and glass do not require additional aeration. However, items made of gas 
absorbent material must be aerated at a minimum room temperature of 68° F (20° 
C) for at least 24 hours prior to use. Any ethylene oxide retained in an item could 
cause a serious chemical contact bum to the patient. 


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© HINT : The AN74 i/ix can be used for extended aeration. A count-up timer will keep 
track of the time that has passed since the standard cycle was completed. After the 
regular cycle is finished, the sterilizer will continue to ventilate and purge the liner bag 
until: (1) the door is opened; and (2) the EXIT button is pressed. This will turn off both 
pumps and end the cycle. If the door is opened and closed and the EXIT button is not 
pressed, the two pumps will continue to ventilate and purge the liner bag and cabinet. 

• Extended aeration can also take place outside of the sterilizer. In this case, aeration 
should take place in a well-ventilated area that provides at least 10 fresh air 
exchanges per hour so that high concentrations of gas will not build up while 
aerating. 

E. Safety Precautions 
1) Ethylene Oxide Safety 

• Sterilization liner bags should never be reused because they may have a puncture or 
tear. 

• DANGER! Do not allow open flame or sparks near the sterilizer during the 
sterilization cycle because ethylene oxide gas is highly flammable in concentrations 
above 3.0% (30,000 ppm). 

• The 12 and 24-hour sterilization cycles both end with a 2-hour purge cycle, which 
flushes fresh air around the products in the sterilization load. 

• The sterilization liner bag must be purged for 2 hours before the sterilized items are 
removed to prevent the operator from being exposed to more than the OSHA 
permitted level of 5.0 ppm in a 15-minute time period (STEL) while the sterilizer is 
being unloaded. 

• Personnel exposure to ethylene oxide can be monitored by using the personal 
exposure badges, such as the Andersen AN93 AirScan® Badges. The AN93 AirScan 
Kit has both STEL and TWA badges. EO exposure levels should be checked upon 
installation of the sterilizer. We recommend that exposure testing be performed on an 
annual basis. 

• CAUTION. If you come in contact with liquid Anprolene, you should immediately 
wash the affected area with water thoroughly for at least 15 minutes and obtain 
medical attention. 

2) Malfunctions and Power Failures 

• In the event of a purge pump failure, the vent pump will continue to ventilate the 
interior of the cabinet, exhausting gas as it diffuses through the liner bag. A PURGE 
PUMP FAILURE error message will be displayed, and the sterilizer will add 24 
hours of aeration before the display indicates that you may remove your products. (If 
this happens, please call Customer Service for assistance.) 

• In the event of a vent pump failure, the cycle will be aborted, and the purge pump 
will evacuate the liner bag of any remaining gas. (If this happens, please call 
Customer Service for assistance.) 


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• If a power outage occurs during any part of the cycle, the sterilizer is equipped with a 
battery back up on the circuit board that will keep track of elapsed cycle time. When 
power is restored, the cycle will continue. Do not open the door of the sterilizer until 
power is restored and the vent/purge systems have removed any residual gas from 
the liner bag. 

© HINT: In the case of any sterilizer malfunction or power failure, you can determine 

whether sterilization was achieved by examining the Steritest biological indicator 

included in the load. 

3) Reasons for locking the Anprolene sterilizer: 

1. To protect the contents from spark or flame. 

2. To protect the liner bag from puncture. 

3. To ensure the Anprolene sterilizer exhausts the ethylene oxide through the 
ventilation system and abator, if installed, to the outside. 

Note: No other container or sterilizer can be used with Anprolene sterilizing gas. 

4) Reasons why the gas release bag containing the ampoule should never be opened: 

1. To prevent the liquid ethylene oxide from coming in contact with the user or the 
items to be sterilized. 

2. To prevent the gas from escaping too quickly to achieve sterilization. 


Things that CAN be sterilized with Anprolene: 


ELECTRICAL DEVICES 

SURGICAL DEVICES 

ENDOSCOPES 

Flashlights 

Scalpels & sharps 

Endoscopes 

Drills 

Scissors 

Cameras 

Dremmel drills 

Clamps & crimpers 

Fiber optic scopes 

Microdrills 

Dental tools 

Saws 

Rulers 

Forceps 

Biopsy punches 

Dermal punches 

Dilators 

Skin staplers 

Speculi 

Needles 

Neuter clips 

IV sets 

Marking pens 



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[OWNER’S MANUAL | 


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Things that CAN be sterilized with Anprolene but that require additional aeration: 

Any items that are made of rubber, plastic, cloth, are implanted or come in direct contact 
with the skin, require additional aeration. 


CLOTH ITEMS 

Gauze 
Gowns 
Bandages 
Cotton balls 
Masks 

Drape materials 


TUBES 

Suction tubes 
Liposuction tubes 
Catheters 

Endotracheal tubes 
Feeding tubes 
Nasal tubes 

OTHER ITEMS 

Toothbrushes 
Rubber bands 
Rubber tourniquets 
Sponges 


IMPLANTS 

Pacemakers 
Nylon implants 
Implants 


Things that CANNOT be sterilized with Anprolene: 

Liquids, food, and drugs should not be sterilized in ethylene oxide because it may change 
their chemical composition. 


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[OWNER’S MANUAL | 


/SCfl 74i/BM 7^/jc/A nprolene 

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SECTION 5 


Accessories for Use with Anprolene 


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/SCfl 74i/m 7^/jc/A nprolene 

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[OWNER’S MANUAL | 


SECTION 5 

Accessories for Use with Anprolene 



Exposure Indicator Strips 

Immediate assurance of gas exposure! The strips provide a strong color 
change when exposed to Ethylene Oxide. Convenient self-stick backing 
adheres to conventional paper or cloth wrapping. Please note that these 
strips are not intended to be an indicator of sterility. They are a quick 
visual reference when placed on the outside of a package that it has been 
through the sterilization process. 


Exposure Indicator Strips 


AN85 200 units/box 



Package Closure Indicator Strip 

Get visual assurance of gas exposure and seal your packages in one 
step! Strips provide a strong color change through rapid confirma¬ 
tion of EtO exposure. Self-adhesive strips stick to conventional 
paper, CSR wrap, cloth wrapping or Andersen Seal and Peel ®. 

For use with Anprolene and EOGas systems only. 


Package Closure Indicator Strip AN86 200 units/box 



Dosimeter® 

Time, temperature, and EtO concentration are essential to proper 
sterilization. The Dosimeter provides visual assurance that all of these 
parameters have been fulfilled during the sterilization cycle. Results can 
be viewed immediately after sterilization- no laboratory culture 
necessary. We recommend the use of one Dosimeter in the least 
accessible part of the load during each sterilization cycle. 


Dosimeter® 


AN87 25 units/box 



Steritest® Biological Control and Biological Control Incubator 

Steritest reliably verifies that sufficient concentration of EtO killed one 
million B. subtilis spores, the most resistant spore to EtO gas. Two 
control components, a Dosimeter and a bacterial spore preparation in a 
sterile culture medium, reduce the possibility of false positives. 



The Biological Control Incubator incorporates a thermostatically 
controlled 98.6°F (37°C) incubator into a tabletop unit with interior 
dimensions of only 10”x 7”x 8” (25 cm x 17.8 cm x 20.3 cm). 

Steritest® AN80 11 units/box 

Steritest Incubator (120V 60Hz) AN810 1 per box 


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[OWNER’S MANUAL | 



Mini Self-Contained Biological Indicators 

Biological indicators test the effectiveness of EtO sterilization cycle using live 
spores. High population of spores (10 6 Bacillus subtilis) achieves accuracy. 
Compact size allows economical storage. Color change discloses EtO test re¬ 
sults after 48 hours incubation at 37 °C. 

Mini Self-Contained Bis. AN2200 25/box 

AirScan® Badges 

Single-use badges measure 15 minute short term (STEL) or 8 hour 
(TWA) exposure levels to EtO. Worn in the breathing zone of the steri¬ 
lizer operator, badges can document compliance with OSHA regulations. 
Easy to use and provides immediate results. 

AirScan® EtO Monitoring Badge 

8 Hour TWA Kit AN91 1 Kit 

15 Minute STEL Kit AN92 1 Kit 

8 Hour TWA and 15 Minute STEL Kit AN93 1 Kit 



Humidichip® 

Designed specifically for use with Andersen gas sterilization systems, 
this unique device ensures adequate Relative Humidity during the 
sterilization cycle. Each single-use, pre-moistened, 2”x 2” (5 cm x 5 
cm) Humidichip releases up to 4 grams of water vapor. 

Humidichips® AN1071 25/jar 



Self-Seal Sterilization Pouches 

Uncoated paper/propylene-polyester peel pouches provide superior 
bacterial barrier. Packaging is printed with color change indicators for 
EtO and steam sterilization. 


Self-Seal Sterilization Pouches 


3.25” 

x 6.5” 

(82 mm x 165 mm) 

AN2310 

200/box 

3.25” 

x 12” 

(82 mm x 305 mm) 

AN2320 

200/box 

5.25” 

xll” 

(135 mm x 280 mm) 

AN2330 

200/box 

7.5” 

x 14” 

(178 mm x 330 mm) 

AN2340 

200/box 

10” 

x 15” 

(254 mm x 380 mm) 

AN2350 

200/box 


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[OWNER’S MANUAL | 


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Seal and Peel® Packaging / 8” Electric Impulse Heat Sealer 

Supplies tough, transparent, waterproof sealed package. Provides 
extended shelf life. Resists pinholes, abrasion and tearing. Highly 
porous to EtO gas for reliable sterilization and quick aeration. Available 
in a wide range of widths to accommodate various instrument sizes. 



Seal and Peel® Sterilization Packaging 
2”(inside) x 200 ft (5 cm x 60 m) 
3”(inside) x 200 ft (7.5 cm x 60 m) 
5”(inside) x 200 ft (12.5 cm x 60 m) 
7”(inside) x 200 ft (17.5 cm x 60 m) 

Seal and Peel Impulse Heat Sealer 
8” Seal length 110V 60 Hz or 220V 50Hz 


AN820 

2 rolls/box 

AN830 

2 rolls/box 

AN850 

1 roll /box 

AN870 

1 roll /box 

AN90 

1 per box 


If you have questions concerning Andersen Sterilization Accessories, contact an Andersen 
Customer Service Representative at 1-800-523-1276 or 336-376-3000 or visit our website at 
www.anpro.com. 


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SECTION 6 


Warnings, Troubleshooting, 
Error Messages and Alarms 


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[OWNER’S MANUAL | 


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SECTION 6 

Warnings, Troubleshooting, Error Messages and Alarms 


A PLEASE SEE 

/ | \ OWNERS MANUAL 


♦ The AN74 i/ix sterilizer utilizes a maximum of 36 grams of ethylene oxide gas as the 
sterilizing agent in one cycle. Please refer to the MSDS for ethylene oxide included 
in this manual as Appendix F, on page 67, for pre-cautions and chemical properties 
related to toxicity and flammability. 

♦ Do NOT open the sterilizer until the sterilization cycle is completed and the display 
indicates “UNLOAD STERILIZER”. 

♦ Personal protective equipment is not required for normal operation and maintenance 
of this equipment. 

♦ The exhaust port must be properly vented to the outside as specified starting in 
Appendix B, page 46, and ending with Appendix D, page 54. 


Pre-Cycle Error Messages (Before the ampoule is broken) 

6.1. Vent S ensor Failure 

6.2. Purge Sensor Failure 

6.3. Pressure Sensor Failure 

6.4. Vent Pump Failure 

6.5. Purge Pump Failure 

6.6 Cooling Fan Failure 

6.7 Abator Failure 

During Cycle Error Messages (After the ampoule is broken) 

6.8. Close Door 

6.9. Vent Pump Failure (During the initial 12/24 hours of sterilization cycle) 

6.10. Vent Pump Failure (During the 2 hour purge cycle) 

6.11. Purge Pump Failure (During the 2 hour purge cycle) 

Audible Alarms 

6.12 Ventilation Pump Alarm 

6.13 Purge Pump Alarm 

6.14 Abator Alarm 

Power Outage 

6.15 Temporary Loss of Power 


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[OWNER’S MANUAL | 


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Pre-Cycle Error Messages (Before the ampoule is broken): The self test portion 
of the cycle begins when the start button is pressed and ends after the initial purg¬ 
ing of the sterilization liner bag. Ethylene Oxide has not been released into the ster¬ 
ilization liner bag during the self test. Therefore, it is safe to remove the sterilization 
liner bag and its contents from the machine if needed. The self test screen is shown 
below. 


SELF TEST 
OK 

1,000 PUMP HOURS 
FAN 100 % RPM 


If you see this screen, the controller is indicating that the ventilation sensor, purge 
sensor, ventilation pump and cooling fan are all operating correctly. If an abator is 
attached to the sterilizer, it indicates that the abator pump is operating correctly as 
well. The bottom line on this display indicates that the cooling fan is running at 
100% of its nominal revolutions per minute (RPM). 

6.1. VENT SENSOR FAILURE: Failure of the ventilation sensor during the self test 
portion of the cycle will show the VENT SENSOR FAILURE message on the 
screen. A vent sensor failure during the self test is often caused by a defective sensor. 
In this instance, the sensor needs to be replaced. 

6.2. PURGE SENSOR FAILURE: Failure of the purge sensor during the self test por¬ 
tion of the cycle will show the PURGE SENSOR FAILURE message on the screen. 
A purge sensor failure during the self test is often caused by a defective sensor. In 
this instance, the sensor needs to be replaced. 

6.3. PRESSURE SENSOR FAILURE: Failure of the pressure sensor during the self test 
portion of the cycle will show the PRESSURE SENSOR FAILURE message on the 
screen. A pressure sensor failure during the self test is often caused by a defective 
sensor. In this instance, the sensor needs to be replaced. 

6.4. VENT PUMP FAILURE: Failure of the ventilation pump during the self test potion 
of the cycle will show the VENT PUMP FAILURE message on the screen. 

Possible causes of VENT PUMP FAILURE during self test and remedies: 

• The ventilation tubing has become disconnected inside the top cabinet. Reconnect 
ventilation tubing. 

• The ventilation vacuum pump has failed to generate the required vacuum. Replace 
ventilation vacuum pump. 

• The exhaust tubing from the ventilation pump is blocked. Remove obstruction. 


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Response: The cause of failure must be identified and corrected prior to starting the 
sterilization cycle. 

6.5. PURGE PUMP FAILURE: Failure of the purge pump during the self test portion of 
the cycle will show the PURGE PUMP FAILURE message on the screen. 

Possible causes of PURGE PUMP FAILURE during self test and remedies: 

• Tubing inside the bottom cabinet has become disconnected or the sterilization bag is 
not properly secured to the purge tube bobbin with the Velcro strap. Reconnect tub¬ 
ing, recheck the integrity of the sterilization liner bag and retighten the Velcro strap. 

• The purge pump failed to generate the required vacuum. Replace the purge pump. 

• The purge tubing became disconnected inside the top cabinet. Reconnect purge tub¬ 
ing. 

• Exhaust tubing from purge pump is blocked. Remove obstruction. 

Response: The cause of failure must be identified and corrected prior to starting the 
sterilization cycle. 

6.6. COOLING FAN FAILURE: Failure of the cooling fan located in the center rear of 
the top cabinet during the self test portion of the cycle will show the COOLING FAN 
FAILURE message on the screen. 

Possible causes of COOLING FAN FAILURE during self test and remedies: 

• If the fan is running, the cooling fan blade may be partially or completely obstructed. 
This is indicated by a RPM value of less than 70% on the self test screen on the 
previous page. Remove the obstruction, clean the filter and reinitiate the self test. 

• If the fan is running but the indicated RPM value is 0%, the white feedback wire 
from the fan may not be properly connected to the PC board. Check connection. 

• If the fan is not running, check the connection of the red and black lead wires to the 
PC board. If they are properly connected, check the voltage at the PC board 
connector for the red and white wires. If you obtain a reading of 6 VDC, replace the 
fan. If you obtain a reading of 0 VDC, the PC board may need to be replaced. 

6.7. ABATOR FAILURE: Failure of the abator pump during the self test portion of 
the cycle will show the ABATOR FAILURE message on the screen. 

Possible causes of ABATOR FAILURE during self test and remedies: 

• If the BNC Connector on the back of the AN 74 I is not attached to the sterilizer or to 
the Abator, the Abator pump will not start. Check the connection. Listen to the 
Abator to determine if the pump is starting when START is pressed. 

• Check for an obstruction in the tubing between the sterilizer and abator. If there is a 
complete obstruction it can cause an abator failure. Remove the obstruction and 
repeat the self test. 

• The abator pump may have failed. It will need to be replaced to continue. 


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Response: The cause of failure must be identified and corrected prior to starting the 
sterilization cycle. 

Error Messages During the Cycle (After the ampoule is activated) 

6.8. CLOSE DOOR: The CLOSE DOOR message is accompanied by a constant audible 
alarm and indicates that the sterilizer door is open when it should be closed. There is 
a magnetic sensor in the upper left comer of the door frame that senses when the door 
is closed. To turn off the alarm and message, close the door of the sterilizer. 

6.9. VENT PUMP FAILURE (During the initial 12 (or extended 24) hours of the 
sterilization cycle): Please note that sterilization takes place during the initial 12/24 
hours of the cycle. If the vent pump fails during this time, the sterilization process 
has been compromised. 

If the ventilation pump fails during the sterilization portion of the cycle when a sub¬ 
stantial amount of ethylene oxide remains within the sterilizer cabinet and the sterili¬ 
zation liner bag, the paramount concern is the safety of the operator. If a ventilation 
pump failure is sensed, the sterilizer will immediately start the purge pump. The 
purge pump will then remove Ethylene Oxide from both the sterilization liner bag 
and the cabinet by drawing air from the enclosed cabinet, into the sterilization liner 
bag and then exhaust it to the outside thereby minimizing the risk of operator expo¬ 
sure. If this happens, the sterilization time and concentration of ethylene oxide inside 
the sterilization liner bag has been prematurely reduced and the items in the sterilizer 
should not be considered sterile. 

Response: The sterilization cycle is halted and a purge is initiated to minimize the 
possibility of operator exposure to Ethylene Oxide. After the machine has completed 
the two hour purge and is unloaded, the cause of the failure must be identified and 
corrected prior to starting a new sterilization cycle. 

CAUTION!: In this scenario, items in the sterilizer may not be sterile. Items must 
be resterilized prior to use. 

6.10. VENT PUMP FAILURE (During the purge cycle): The sterilization process takes 
place in the first 12 hours of the sterilization cycle. If the vent pump fails during 
hours 12 to 14 (or 24 to 26 during an extended cycle), the sterilization process has 
not been compromised. 

Instead of the vent pump and purge running alternating two minute cycles, the purge 
pump will run continuously. The purge pump will remove Ethylene Oxide from both 
the sterilization liner bag and the cabinet by drawing air from the enclosed cabinet, 
into the sterilization liner bag and then exhaust it to the outside thereby minimizing 
the risk of operator exposure. 


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If examination of the sterility indicators included with the load indicate adequate 
time/concentration exposure to ethylene oxide, the items in the sterilizer may be con¬ 
sidered sterile. The vent pump failure message will be displayed after the entire cy¬ 
cle is complete, and the door has been opened to remove the load from the sterilizer. 

Response: Sterilization cycle was completed normally. After the machine is 
unloaded, the cause of the failure must be identified and corrected prior to starting a 
new sterilization cycle. 

6.11. PURGE PUMP FAILURE (During the purge cycle): The sterilization process 
takes place in the first 12/24 hours of the sterilization cycle. If the purge pump fails 
during the purge cycle, hours 12 to 14 (or hours 24 to 26 for extended cycles), the 
sterilization process has not been compromised. However, if the purge pump fails, 
there will be abnormally high concentrations of Ethylene Oxide inside the steriliza¬ 
tion liner bag at the end of the normal 14 hour cycle. In response to this failure, the 
sterilizer will: (1) immediately start the vent pump, which will now run continuously 
until the end of the cycle; (2) add 24 hours to the total cycle time; and (3) display a 
PURGE PUMP FAILURE message on the screen. 

During this additional 24 hour aeration time, most of the remaining Ethylene Oxide 
will pass through the wall of the sterilization liner bag. The sterilizer will count 
down 24 hours and then instruct the operator to release the Velcro strap from the 
neck of the sterilization liner bag and immediately close the door. The sterilizer will 
then count down an additional 2 hours of aeration time to remove any residual Ethyl¬ 
ene Oxide from the opened sterilization liner bag within the cabinet. If examination 
of the sterility indicators included with the load indicate adequate time/concentration 
exposure to ethylene oxide, the items in the sterilizer may be considered sterile. 

Response: Sterilization cycle was completed normally, however, the sterilization 
liner bag was not fully purged. The sterilizer will add 24 additional hours to the cy¬ 
cle to allow residual Ethylene Oxide to pass through the sterilization liner bag. After 
the machine is unloaded, the cause of the failure must be identified and corrected 
prior to starting a new sterilization cycle. 

ALARMS: If a critical component of the sterilizer fails during any part of the cycle, the 
controller will notify the operator by means of a visual display and an audible alarm: 

6.12 Ventilation Pump Alarm: If the cabinet ventilation pump fails to maintain an ade¬ 
quate vacuum for 20 consecutive seconds while the ventilation pump is running, an 
alarm will sound continuously and the display will read: VENT PUMP FAILURE. 
The audible alarm may be silenced by pressing the EXIT button. 


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The ventilation sensor monitors the vacuum between the cabinet ventilation pump and 
the interior of the cabinet. The pressure within the cabinet relative to the room is 
negative (vacuum) which ensures the sterilizing gas which has diffused through the 
walls of the sterilization liner bag is retained within the cabinet. 

Before the ventilation pump is turned on at the beginning of the cycle, the controller 
tests to make sure the ventilation sensor is reading zero vacuum. It then turns on the 
ventilation pump and checks to see if there is adequate vacuum. If the vacuum is less 
than 0.25 inches of water vacuum, the VENT PUMP FAILURE message will be dis¬ 
played. 

During the entire sterilization and ventilation cycle, the amount of vacuum created by 
the ventilation pump is also continuously monitored while the vent pump is running. 
If a VENT PUMP FAILURE message is displayed, the audible alarm may be silenced 
by pressing the EXIT button. 

As an automated safety precaution, if the cabinet ventilation pump fails at any time 
during the 12 (or 24) hour sterilization cycle, the purge pump will automatically start 
and run continuously for the remainder of the sterilization and ventilation cycle. The 
sterilization liner bag will be vacuumed down until the check valves in the purge tube 
open at 3.0” (7.6 cm) of water vacuum. At this point the check valves will open and 
the cabinet will then be vented through the sterilization liner bag for the remainder of 
the cycle. 

6.13 Purge Pump Alarm: Similarly, the purge pump sensor monitors the vacuum within 
the tubing that connects the purge pump to the sterilization liner bag. Before the purge 
pump is turned on at the beginning of the cycle, the controller tests to make sure the 
purge sensor is reading zero vacuum. The purge pump is then turned on and the sterili¬ 
zation liner bag is vacuumed down. The controller checks to make sure the vacuum is 
greater than 5.00 inches of water vacuum. Otherwise, the controller will display a 
PURGE PUMP FAILURE message. 

During the 2 hour ventilating bag cycle at the end of the 12 (or 24) hour sterilizing cy¬ 
cle, the amount of vacuum created by the purge pump is also continuously monitored 
while it is running. If the vacuum created by the purge pump is inadequate for 20 con¬ 
secutive seconds, a PURGE PUMP FAILURE message is displayed. 

If the purge pump fails during the 2 hour ventilation cycle, the controller will 
automatically add 24 hours to the cycle time to allow the remaining Ethylene Oxide 
contained within the sterilization liner bag to diffuse through the walls of the steriliza¬ 
tion liner bag as opposed to being flushed with fresh air for 2 hours, as would occur 
during normal operation. 


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The first purge cycle takes place immediately prior to activation of the Anprolene am¬ 
poule and commencement of the sterilization cycle. This cycle lasts for 1 minute, 30 
seconds and is displayed as the INITIAL PURGE. 

The second purge cycle is automatically initiated when the sterilization cycle has 
reached the end of the 12 (or 24) hours. The purge cycle continues for two hours with 
the display showing VENTILATING BAG - 02:00:00 REMAINING and counting 
down to zero. At the end of the two hours, the sterilizer can be unloaded. The purge 
pump runs for two minutes and then turns off for two minutes, alternating with the ven¬ 
tilation pump during the ventilation cycle. 

If the two hour VENTILATING BAG period has expired but: (1) the door to the steri¬ 
lizer has not been opened; and (2) the EXIT button has not been pressed, the sterilizer 
will continue to intermittently purge the sterilization liner bag. It will remain on this 
schedule indefinitely until the door is opened and the EXIT button is pressed. In addi¬ 
tion, the display will show a count-up timer indicating additional aeration time. 

6.14 Abator Alarm: The alarm will beep 3 times on startup if the abator is down to 25 or 
fewer remaining cycles. A constant alarm sounds when the abator is down to 0 cycles 
remaining. 

6.15 Power Outage: The program in the microchip is protected from power loss by a bat¬ 
tery which is built into the clock chip mounted on the circuit board. The design enables 
the program to continue in the event of a power loss by using the backup battery 
power. 

If a power outage occurs during the sterilization portion of the cycle, the program will 
continue without interruption as if a power outage did not occur since the items inside 
the sterilization liner bag will still be exposed to the Anprolene gas for the same 
amount of time even if the power is off. 

If a power outage occurs during the ventilation portion of the cycle, the program will 
record how long the sterilization liner bag was ventilated prior to the power outage (for 
example, 30 minutes) and it will resume the countdown for the remainder of the 2 hour 
ventilation cycle, (in this example, an additional 1 hour, 30 minutes). 


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SECTION 7 


Maintenance 


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SECTION 7 
Maintenance 

7.1. The cabinet ventilation pump and the sterilization liner bag purge pump have an ex¬ 
pected life of 18,000 hours (this translates to approximately five cycles per week for five 
years). During this time, the pumps are designed to pump at or above minimum required 
volumes of exhaust air at up to 27 inches of water backpressure. The total number of hours 
that the pumps have run is displayed on the Liquid Crystal Display at the beginning of each 
sterilization cycle. 

When the pumps have been in operation for more than 18,000 hours (approximately 1,300 
sterilization cycles), it is recommended that the complete sterilizer unit be returned to the 
factory for replacement and/or refurbishment of the pumps and associated tubing. Call 
Andersen Products Customer Service for return authorization and pricing. 

7.2. On a semi-annual basis, or every 1,800 hours of operation, the following mainte¬ 
nance should be performed: 

a. Check the quick connect fittings and the tubing that runs from inside the upper 
right hand comer of the sterilizer cabinet to the purge tube. 

b. All external tubing and tubing connections that are visible, and therefore 
accessible to the operator, should be checked to make sure they are secure and that 
there are no visible signs of degradation such as cracking or splitting. 

c. Check the exhaust tubing connections at the back of the sterilizer and perform a 
leak test as detailed in Appendix D, page 55 and following. 

d. The filter media attached to the cooling fan in the rear of the top cabinet should be 
removed, cleaned and reattached. 

7.3 All exterior surfaces and the interior surfaces of the lower cabinet should be cleaned 
using a cotton cloth and a mild soap and water solution. Do not use abrasive pads as this 
may mar the finish of the stainless steel and plastic molded fittings. 


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APPENDIX A 


Technical Features 


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APPENDIX A 
Technical Features 

A.l. Cabinet: The AN74///x cabinet is assembled from grain finish stainless steel with 
molded ABS front and rear end plates. The door is assembled from a molded polystyrene 
outer door and inner stainless steel liner. The door is provided with an exterior grain finish 
stainless steel cover panel, door support arm and latching lock with removable key. 
Protective rubber feet are attached to the lower cabinet panel. 

A.2. Pumps: The lower cabinet is ventilated by means of two linear oscillating pumps 
located in the enclosed top cabinet. The pumps remove the air from inside of the lower 
cabinet and sterilization liner bag and exhaust the air to the outside. The 3/4” (1.9 cm) in¬ 
side diameter braided PVC tubing may be up to 200 feet (60.96 meters) in length. During 
sterilization and ventilation cycles, the pumps maintain a negative pressure (vacuum) in the 
lower cabinet with respect to the room where the sterilizer is located. If an abator is in¬ 
stalled it uses a third linear pump that is enclosed in the abator cabinet. 

A.2.a. Ventilation Pump: The cabinet ventilation pump will run continuously from 
the time the operator pushes the START button at the beginning of the cycle until the 12 
or 24 hour sterilizing cycle is complete. After that, during the 2 hour purge cycle, it will 
alternate with the purge pump, running for two minutes and then shutting down for two 
minutes until the operator: 

1.Opens the door to remove the sterilized items; and 
2.Presses the EXIT button. 

The cabinet ventilation pump is designed to exhaust the lower cabinet at a minimum rate 
of 38 liters per minute. These specifications are for a cabinet equipped with a maximum 
of 200 feet (60.96 m) of 3/4” (1.9 cm) inside diameter braided PVC tubing with one 90° 
bulkhead fitting at the back of the cabinet and one 90° bulkhead fitting at the interior 
wall above the sterilizer. 

Additional Aeration: If the operator wishes to use the sterilization cabinet to further 
aerate the sterilized items after the normal 14/26 hour sterilization and ventilation cycles 
are completed, the operator may simply leave the sterilizer running when the UNLOAD 
STERILIZER screen appears. A count-up timer will appear on the screen showing the 
additional aeration time after the end of the normal 14/26 hour sterilization and aeration 
cycle. When the operator wishes to stop the additional aeration, they simply need to fol¬ 
low the steps outlined in A.2.a. above. 

A.2.b. Purge Pump: The second exhaust pump, referred to as the purge pump, is 
connected to the purge tube assembly and sterilization liner bag by a tube connected to 
the front right comer of the lower cabinet. Purging is the intermittent flushing of the 
sterilization liner bag with fresh air and takes place at the beginning and end of the cycle. 


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APPENDIX B 


Installation Requirements 


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APPENDIX B 
AN74i Anprolene Sterilizer 

Dimensions and Clearances and Installation Requirements 



Total weight is 
approximately 50.5 
pounds (22.9kg). It 
is advisable to have 
two persons assist in 
the installation or 
moving of the 
machine. Refer to 
installation 
instructions in 
Appendix C for 
detailed instructions. 


APPENDIX B 

AN74ix Anprolene Sterilizer 

Dimensions and Clearances and Installation Requirements 



Total weight is 
approximately 60.5 
pounds (27.5kg). It 
is advisable to have 
two persons assist in 
the installation or 
moving of the 
machine. Refer to 
installation 
instructions in 
Appendix C for 
detailed instructions. 


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APPENDIX B 

Dimensions and Clearances and Installation Requirements 

B. 1 The AN74 i/ix Sterilizer consists of three major components: (1) a lower cabinet which 
is used to contain the items being sterilized; (2) an upper cabinet containing the controller, user 
interface display and pneumatic equipment to ventilate the lower cabinet and sterilization bag; 
and (3) a 3/4” (1.9 cm) I.D. exhaust tube and fittings which vent the Ethylene Oxide laden air 
from the lower cabinet and sterilization liner bag to the outside. 

B.2 The total weight of the AN74 i/ix is approximately 50.5 pounds (22.9 kg) / 60.5 pounds 
(27.5 kg). It is advisable to have two persons assist in the installation or moving of the ma¬ 
chine. Refer to installation instructions in Appendix C and following for detailed instructions. 
Place the sterilizer cabinet on a sturdy counter space or workbench at a height convenient for 
loading. 

B.3 CAUTION!: The Anprolene sterilizer cabinet location must be adjacent to an Un- 
Switched , grounded power outlet, preferably one that is dedicated to its exclusive 
use. The standard Anprolene sterilizer is fitted with a 7 foot long (220 cm) power cord. 

B.4. Whenever possible, the Anprolene sterilizer should be located against an outside 
wall, and exhaust directly to the outside by means of 3/4” (1.9 cm) I.D. tubing to minimize 
the impedance of the exhaust system. 

CAUTION!: The exhaust outlet should not be located near a common area. 


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APPENDIX C 


Installation Instructions for 
New Anprolene Users 


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APPENDIX C 


Installation Instructions for New Anprolene Users 


C. 1 Unpacking - The combined upper and lower sterilization cabinet weighs 
approximately 50.5 pounds / 60.5 pounds. To avoid possible injury, it is recommended that 
two persons assist in removing the sterilizer from the shipping box and placing the sterilizer 
wherever it will be used. 

To unpack the sterilizer, gently turn the packing box upside down on the floor. Next, slit the 
tape along the center edges of the bottom flaps and fold all four flaps down against the sides 
of the box. Leave the bottom foam packing insert in place and turn the packing box back to 
its original upright position. Pull the box up and off of the sterilizer. Remove the top foam 
packing insert. 

Each side of the painted steel enclosure has a turned under bottom edge that is raised up off 
the ground approximately 3/4” (1.9 cm). One person should now take hold of the left bot¬ 
tom edge while the other takes hold of the bottom edge on the opposite side of the sterilizer 
and lift it up out of the bottom foam insert and place the sterilizer on the counter surface 
where the unit is to be installed. 


Confirm that you have the following items: 

• AN74 i/ix Anprolene sterilizer upper and lower cabinet unit 



(A) Eight toggle inserts and Phillips screws to secure the 
mounting plates. 

(B) Exterior wall mounting plate with black plastic bushing. 

(C) Eight foot length of 3/4" (1.9 cm) I.D. clear braided PVC 
tubing and two stainless hose clamps (included with sterilizer). 

(D) Interior wall mounting plate with 90° elbow fitting 
assembly and 20" (50.8 cm) length of black 3/4" (1.9 cm) I.D. 


tubing for through wall penetration 
• (E) Owner’s Manual 


C.2 The following tools will be needed for installation of the sterilizer: 

• Electric drill 

• 3/8” (0.95 cm) drill for the toggles 

• 1/4” to 3/8” diameter drill bit that is longer than the exterior wall is thick 

• 2” (5.08 cm) hole saw 

• Medium flat blade screwdriver 

• Medium Phillips screwdriver 

• Razor knife, and 

• Soapy water solution in a squirt bottle for leak testing. 

C.3 Temporarily position the sterilization cabinet in the appropriate location, as described 
in Appendix B. 


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C.4 Interior Wall Mounting: Choose a location on the wall that is 
directly above the exhaust bulkhead fitting coming out of the back 
of the sterilizer (See lower picture on page 3). This is the location 
where the exhaust hose will run through the wall to the outside. 

CAUTION! Make sure you are not drilling into any struc¬ 
tural members, wires or pipes. With the long drill bit, drill all 
the way through to the outside. 

C.5 Using a 2” hole saw bit, enlarge the pilot hole on the inte¬ 
rior surface of the wall to 2”. Repeat this process on the exterior 
surface of the wall using the pilot hole as the center point. You 
should now have a 2” hole through the entire wall. 


C.6 Take the Interior wall plate assembly (marked "D") with 
the 90 degree elbow attached and insert the black tube through the 
hole to the outside. Center the tube inside the 2” diameter hole 
and mark the location of the four plastic toggles. 


C.7 Remove the interior wall plate assembly and drill the four 
toggle mounting holes using a 3/8” (.95 cm) bit. 


C.8 Insert four of the toggles into the interior mounting holes 
and tap them flush against the inside surface of the wall. 


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C.9 Insert the black hose that is attached to the interior plate 
assembly into the two inch hole and line up the four mounting 
holes with the four toggles. 

The gray interlock button on the fitting should be facing up. 


C.10 Secure the interior mounting plate assembly to the interior 
wall by threading the Phillips screws into the four toggles. 



C.l 1 Take one end of the eight foot length of 3/4" (1.9 cm) I.D. 
clear braided PVC tubing and slip one of the stainless steel hose 
clamps over the end. Next, push the tubing as far as it will go 
onto the 90 degree hose barb connector on the back of the cabinet. 
Then secure the PVC hose by tightening the stainless hose clamp 
with a flat blade screw driver. 



C.12 Move the sterilizer into its permanent location and then 
stretch the clear braided PVC tubing up to the 90 degree wall 
mount fitting. Allow for an extra inch or two and cut to length. 
Slip a stainless steel hose clamp over the tubing and then push the 
tubing as far as it will go onto the 90 degree hose barb connector. 
Secure the PVC tubing with the second stainless steel hose clamp. 



C. 13 Exterior Wall Mounting: Slide the exterior mounting plate 
over the black PVC tubing that extends out through the 2” hole 
and then mark the four mounting holes. 


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C.14 Repeat steps C.7 and C.8 by drilling the four toggle mount¬ 
ing holes and inserting the toggles. Secure the exterior plate to the 
wall with the four Phillips screws provided. Depending on the 
thickness of your exterior wall, you may wish to trim off excess 
black tubing that protrudes from the exterior plate with a utility 
knife. Make sure you leave at least three inches protruding out 
from the metal plate and make sure you cut the tubing at a 45 de¬ 
gree angle with the long end of the cut on the top of the tube. 

C.15 Initial Operation - Once the installation of the exhaust tub¬ 
ing is complete, ensure that the purge tube is connected inside the 
cabinet. The purge tube connects the sterilizer via an acetyl quick 
connect fitting that is located on the front right comer of the lower 
cabinet’s ceiling. Check to make sure the power cord is connected 
to the back of the sterilizer and is plugged into an un-switched, 
grounded power outlet. 


C. 16 Turn the sterilizer on with the black power switch located 
on the back right comer of the upper cabinet. The sterilizer will display the following 
screen: 


AN74I 

ANPROLENE STERILIZER 
START 


C. 17 Press the button next to START and the sterilizer will perform a self test on the 
cabinet ventilation pump. 


AN74I 

ANPROLENE STERILIZER 
START 




C.18. The display will then show the current version of the microchip program, and “OK” 
indicating the cabinet ventilation pump is functioning properly. It will also display the total 
number of hours that the evacuation pumps have been running since the unit was manufac¬ 
tured. The bottom line displays a number indicating the blade speed of the rear cooling fan. 


SELF TEST 
OK (VER. 4.04) 
16 PUMP HOURS 
FAN 100 % RPM 


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C.19. At the end of the initial self test, the following screen will be automatically displayed. 
Pressing the button to the right of PURGE will cause the sterilization bag purge pump to 
operate for 1 minute, 30 seconds. This, in turn, will cause air to flow through the steriliza¬ 
tion liner bag, up the 1/4" (.64 cm) I.D. purge tube into the purge pump, and then out the 
3/4” I.D. exhaust tube creating an exhaust pressure of approximately one to three inches of 
water inside the exhaust tube at the rear of the sterilization cabinet. 


LOAD STERILIZER BAG 
CLOSE BAG OVER TUBE 
PURGE BAG 

EXIT PURGE 



C.20 Checking Connections - The final step in the installation process is to make sure the 
fitting connections outside the cabinet are airtight. One method of testing for leaks is to 
squirt a soapy water solution onto the connections when the sterilizer pumps are running as 
explained below. 


C.21. While the pumps are running, squirt or pour a small amount of 
the soapy water solution onto the visible connections. If you see any 
air bubbles that are growing larger, this is an indication that air is 
escaping from the fitting. Tighten the stainless hose clamps further 
until the bubbles stop getting larger. 




C.22. At the end of the initial purge cycle, the following screen will 
appear. If you do not want to run a cycle at this time you may sim¬ 
ply turn the power off by pressing the on/off switch on the right rear 
comer of the top cabinet. 


BREAK AMPOULE 
CLOSE DOOR 
SELECT CYCLE LENGTH 
24 HOUR 12 HOUR 


The unit may now be placed into service as instructed in Section 3, 
beginning on page 12.. 


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APPENDIX D 


Installation Instructions for 
Current Anprolene Users 


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APPENDIX D 

Installation Instructions for Current Anprolene Users 


The following instructions are for current users of ventilated AN74C, D or E Anprolene® 
systems. The adaptor kit included with your new sterilizer allows for an easy conversion 
from the 2 ” outlet hose used with earlier Anprolene systems to the 3/4 ” ID. outlet hose of 
the AN74 i/ix 

The following items are included in the adaptor kit: 



1 PVC adaptor PVC glue 

1 90° hose barb fitting 
1 Stainless steel hose clamp 


r i 

Section D.l. Directions To Remove Blower and Check Previous Installation of Pipe 

s_ / 

D. 1.1 Remove the existing ventilation unit from the wall by 
removing the 4 small metal screws at each corner. 


D. 1.2 This will expose the plastic mounting plate underneath. 


D. 1.3 At the time of initial installation, the 2” pipe leading to the 
outside should have been sealed with a light coat of 
silicone caulking and pressed firmly into the hole in the 
mounting plate. To check whether or not this occurred, 
remove the 4 remaining screws and gently test the 
connection between the pipe and the mounting plate by 
rotating the plate. 

If the pipe is not secure, continue on to Section D.2. If the pipe is secure, reattach the 
mounting plate with the original 4 screws, and advance to Section D.3. 



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[OWNER’S MANUAL | 


-\ 

Section D.2. Securing the PVC 

___/ 

D.2.1 Clean the Mating Surfaces. Remove the mounting plate from the 
wall and clean the outside surface of the 2” PVC pipe as well as the interior 
surface of the tube extending from the back of the plate with rubbing alcohol 
and allow to dry. 

D.2.2 Correct Position of the Wall Plate. After the PVC glue is applied as 
detailed in the next paragraph, you must quickly slide the mounting plate all 
the way onto the pipe until it bottoms out against the lip of the mounting 
plate. Then you must immediately align the four holes in the mounting plate 
with the four mounting toggle holes in the wall by rotating the mounting 
plate as needed. 

D.2.3 Gluing the Wall Plate to the PVC Tube. Apply a thin film of PVC 
glue to each of the mating surfaces. QUICKLY press the wall plate onto 
the PVC pipe. The glue acts as a lubricant, so it will easily slide in. NOTE: 
There can be no delay in sliding the wall plate onto the pipe after apply¬ 
ing the glue. The glue dries in seconds and any delay may prevent cor¬ 
rect alignment. Wipe off any excess PVC glue from the interior of the pipe 
with a paper towel 

D.2.4 Secure the Mounting Plate to the Wall. Screw the mounting plate to 
the wall using the original 4 small screws. 


r 1 

Section D.3. Inserting the PVC Adaptor 

s_ * 

D.3.1 Before inserting the PVC adaptor, test the fit by placing the adaptor 
into the hole. If necessary, clean the mating surfaces with rubbing alcohol. 


D.3.2 Apply a thin film of PVC glue to each of the mating surfaces, includ¬ 
ing the inside of the 2” PVC pipe. 






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[OWNER’S MANUAL | 



D.3.3 QUICKLY press the adaptor all the way into the hole. The glue 
acts as a lubricant, so it will easily slide in. NOTE: There can be no de¬ 
lay in sliding the adaptor into the hole after applying the glue. The 
glue dries in seconds and any delay will prevent correct placement. 



D.3.4 Screw in the black nylon 90° hosebarb fitting and align the barb end 
such that it is pointing down. 


D.3.5 Take one end of the eight foot length of 3/4" (1.9 cm) I.D. clear 
braided PVC tubing and slip one of the stainless steel hose clamps over 
the end. Next, push the tubing as far as it will go onto the 90 degree hose 
barb co nn ector on the back of the cabinet. Then secure the PVC hose by 
tightening the stainless hose clamp with a flat blade screw driver. 



D.3.6 Move the sterilizer into its permanent location and then stretch the 
clear braided PVC tubing up to the 90 degree wall mount fitting. Allow for 
an extra inch or two and cut to length. Slip a stainless steel hose clamp over 
the tubing and then push the tubing as far as it will go onto the 90 degree 
hose barb connector. Secure the PVC tubing with the second stainless steel 
hose clamp. 


D.3.7 Refer to Section C. 15 and the following steps on page 53 of the man¬ 
ual for initial operation and leak testing the co nn ections. 


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APPENDIX E 


Software/User Interface Flowcharts 


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Flowchart for Normal Operating Screens 



AN74I 

. ANPROLENE STERILIZER 
START 


250 ABATOR CYCLES 
REMAINING 


When 

START 

pressed 


SELF TEST 
VER 4.04 

1,000 PUMP HOURS 
FAN 100 % RPM 


T 


SELF TEST 
OK 

1,000 PUMP HOURS 
FAN 100 % RPM 


LOAD STERILIZER BAG 
CLOSE BAG OVER TUBE 
PURGE BAG 

EXIT PURGE 


INITIAL PURGE 
00:01:30 REMAINING 


EXIT 


When 

PURGE 


The ability to EXIT the 
cycle at this point is to 
allow the operator to 
return to the standby 
state if the ampoule has 
not been broken. 


Continued next page 


If Abator Attached (optional): 

On initial startup the sterilizer will indicate the num¬ 
ber of remaining abator cartridge cycles. 

Initial Abator Self Test: 

1. Abator Cartridge - checks cycles remaining 
(countdown). If more than 25, continues without 
change in display. If equal to or less than 25 cy¬ 
cles remaining, beeps 3 times to notify operator. 

If cycles remaining equals 0, the machine beeps 
continuously. The cartridge has expired and 
should be replaced. Additional cycles are not 
recommended but the screen may be bypassed by 
pressing the BYPASS button. 

2. Abator Pump - tests vacuum on exhaust line 


Initial Self Test: 

1. Cooling Fan Speed - tests fan speed as a percent¬ 
age of nominal speed 

2. Purge Sensor - checks purge sensor offset value 

3. Ventilation Sensor - checks ventilation sensor 
offset value 

4. Back Pressure Sensor - checks back pressure 
sensor offset value 

5. Purge Pump - tests vacuum on inlet to purge 
pump 

6. Ventilation Pump - tests vacuum on input to 
ventilation pump 

7. Back Pressure - tests pressure on exhaust line 


PUMP HOURS 

This message is displayed every time the 
START button is pressed. It displays the total 
number of hours that the ventilation pump 
(VENT PUMP) has operated. The pump 
should be serviced or replaced on a regular 
schedule. See the maintenance information in 
Section 7 of this manual for details. 


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[owner’s manual | /SCfl 74i/BM\ 74 ix/ 

Flowchart for Normal Operating Screens, continued 


Continued from previous page 


After the initial 
purge has been com¬ 
pleted, the operator 
breaks the ampoule 
and closes the door. 
If the operator does 
not select the cycle 
length within 5 sec¬ 
onds, an alarm will 
sound continuously 
as a reminder. 


At the end of the cycle, 
the operator opens the 
door and removes the 
load. The operator then 
closes the door and 
presses the EXIT button. 
This returns the steri¬ 
lizer to the standby 
state. 




AN74I 

ANPROLENE STERILIZER 
START 


the EXIT button is pressed. 
Therefore, items may be left in 
the machine for further aera¬ 
tion after the cycle has ended. 


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[OWNER’S MANUAL | 


/SCfl 74i/& ftO 7^/jc/ Anprolene 

' ' \as sterilization 


Flowchart for Technical and Diagnostic Screens 


These screens are used by authorized service technicians and installers only, to check the vacuum created 
by the abator pump, ventilation pump and purge pump. The screens are used for diagnostic and installation 
purposes and would not normally be used by the operator of the machine. 



No pumps 
running, 
all sensors 
should 
equal 0. 


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Flowchart for Pre-Cycle Error Messages 


Possible Error Messages: 


BACKPRESSURE HIGH 
CHECK EXHAUST 
TUBING & FITTINGS 
EXIT BYPASS 


AN74I 

ANPROLENE STERILIZER 
START 


PURGE SENSOR FAILURE 
VENT SENSOR FAILURE 
PRESS SENSOR FAILURE 
PURGE PUMP FAILURE 
VENT PUMP FAILURE 
ABATOR FAILURE 

REFER TO ERROR 
SECTION OF MANUAL 
EXIT 


COOLING FAN FAILURE 
CHECK REAR FAN 
OPERATION & FILTER 
EXIT BYPASS 


250 ABATOR CYCLES 
REMAINING 


When 

START 

pressed 


SELF TEST 
VER 4.04 

12,000 PUMP HOURS 
94 % FAN RPM 


SELF TEST 
OK 

12,000 PUMP HOURS 
FAN 94 % RPM 


Go to normal operating screens 


COOLING FAN FAILURE indicates the cooling fan in the top did 
not reach the required operating speed (70% of rated speed) 

PURGE SENSOR, VENT SENSOR or PRESSURE SENSOR 
FAILURE indicates the offset of the specified sensor was out of range 
(> =0.1 AND <= 0.4) prior to starting the ventilation pump. 

PURGE PUMP FAILURE indicates the purge sensor or the purge 
pump failed or the purge tubing became disconnected. 

VENT PUMP FAILURE indicates the ventilation tubing is blocked 
or disconnected, the ventilation sensor failed or the ventilation pump 
failed. 

ABATOR FAILURE indicates the exhaust tubing blocked, discon¬ 
nected or the abator pump failed. 

BACK PRESSURE HIGH indicates the exhaust tubing is blocked. 

EXIT returns to the startup screen 


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[OWNER’S MANUAL | 


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Flowchart for Ventilation Pump Failure During Sterilization Cycle 


If a VENT PUMP FAILURE occurs during 
the sterilization cycle, the screen will display 
the error message, and the machine will beep 
continuously until the ALARM button is 
pressed. This alerts the operator to the prob¬ 
lem. The purge pump will start and remain on 
for the remainder of the normal cycle time. 


Press ALARM OFF 
to stop the alarm 


In this case, sterilization has been stopped dur¬ 
ing the cycle and the Ethylene oxide in the 
liner bag was removed by the purge pump. 

ITEMS IN THE LINER BAG SHOULD NOT 
BE CONSIDERED STERILE 


The machine may be unloaded once the 
counter reaches 0:00:00, but the items in the 
liner bag should be resterilized prior to use 


Refer to the Error and Troubleshooting sections 
of the manual for information about repairing the 
sterilizer 

To reset the machine, shut off the machine power. 
Then, while holding both buttons, turn on the 
power. Release buttons after the display shows 
characters. 



AN74I 

ANPROLENE STERILIZER 


START 


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Flowchart for Ventilation Pump Failure During Ventilation Cycle 


i 


12 (or 24) HOUR CYCLE 
STERILIZING 
1:53:15 REMAINING 


If a VENT PUMP FAILURE occurs during 
ventilation cycle, the screen will display the 
error message, and beep continuously until 
the ALARM button is pressed. The purge 
pump will remain on for the remainder of 
the normal cycle time and will ventilate the 
cabinet. 


Press ALARM OFF 
to stop the alarm 

In this case, sterilization has been com¬ 
pleted prior to the failure of the pump. 



U 

VENTILATING BAG 
0:20:12 REMAINING 


V 


VENTILATING BAG 
VENT PUMP FAILURE 
0:20:01 REMAINING 
ALARM OFF 



ITEMS IN THE LINER BAG MAY BE 
CONSIDERED STERILE 


The machine may be unloaded once the 
counter reaches 0:00:00, and the items may be 
used normally 


Refer to the Error and Troubleshooting sections of 
the manual for information about repairing the 
sterilizer 

To reset the machine, shut off the machine power. 
Then, while holding both buttons, turn on the 
power. Release buttons after the display shows 
characters. 


U 



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[OWNER’S MANUAL | 


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Flowchart for Purge Pump Failure During Ventilation Cycle 



The PURGE PUMP FAILURE message will 
remain on the screen. At the end of the ex¬ 
tended cycle, the operator should: (1) open the 
door; (2) remove the Velcro strap and open the 
mouth of the bag; and (3) close and lock the 
door. 

Continue ventilation for an additional 2 hours. 
Open the door and press EXIT. Then remove 
the items from the cabinet as you normally 
would. 

ITEMS IN THE LINER BAG MAY BE 
CONSIDERED STERILE 


Refer to the Error and Troubleshooting sections 
of the manual for information about repairing the 
sterilizer 

To reset the machine, shut off the machine power. 
Then, while holding both buttons, turn on the 
power. Release buttons after the display shows 
characters. 



V 



- - Count up timer 





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[OWNER’S MANUAL | 


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Flowchart for Close Door Error Message 


Starting at the sterilizing screen, 
the CLOSE DOOR message will 
be displayed and the alarm will 
sound if the door is opened at any 
time before the UNLOAD STERI¬ 
LIZER screen. It has priority over 
all other screens. 

If the door is closed, the screen 
will return to the normal time re¬ 
maining screen. 



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[OWNER’S MANUAL | 


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APPENDIX F 


Material Safety Data Sheets 


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APPENDIX F 

Material Safety Data Sheets—Ethylene Oxide 


Section 1 

Chemical Product & Company Identification 


Product: ANPROLENE® 

Manufactured by: 

Andersen Sterilizers, Inc. 

Health Science Park 
3154 Caroline Drive 
Haw River, NC 27258 USA 

Information Telephone Number: (336) 376-8622 
r 

Emergency Telephone Number 
(24 HRS, 7 DAYS PER WEEK) 
CHEM-TEL (800)-255-3924 


Section 2 

Composition/ Information on Ingredients 


Chemical Name: 
Weight By %: 
Chemical Family: 
Formula: 

Molecular Weight: 
CAS Number: 

CAS Name: 
Synonyms: 


Product Uses: 


Ethylene Oxide 
84 to 97% 

Epoxide 

(CH 2 ) 2 0 

44.06 gms/mole 

75-21-8 

Oxirane 

EO, EtO, Dihydroxirene, 

1-2 Epoxyethane, Dimethylene Oxide, 

Oxane, Oxirane, Alkene Oxide, Alpha/ 
Beta-Oxidoethane, Oxacyclopropane. 
Chemical intermediate for production of anti¬ 
freeze, polyester resins, non-ionic surfactants 
and specialty solvents; sterilizing agent for 
controlling microorganisms in health care 
applications; fumigant for controlling insect 
infestation in whole and ground spices and 
cosmetics. 


Section 3 

Hazard Identification 


EMERGENCY OVERVIEW 


Colorless liquid or heavier-than-air gas with a sweet, ether-like odor. 
Extremely flammable liquefied gas which burns in the absence of 
oxygen and can explode when exposed to elevated temperatures. 
Toxic when inhaled. Causes severe skin and eye irritation or burns 
and respiratory tract irritation; effects may be delayed. Harmful if 
swallowed or absorbed through the skin. Contact with liquid may 
cause frostbite. 


Statement of Hazards: 


DANGER! 

Extremely flammable liquid and gas under pressure. May form 
explosive mixtures with air. Highly reactive. May be harmful if in¬ 
haled and may cause delayed lung injury, respiratory system and 
nervous system damage. Inhalation may cause dizziness or drowsi¬ 
ness. Liquid contact may cause frostbite. May cause allergic skin 
reaction. Harmful if swallowed. May cause adverse blood effects, 
liver and kidney damage based on animal data. Cancer and repro¬ 
ductive hazard. 


HAZARD RATINGS: (0 = minimum; 4 = maximum) 


Health = 3 
Flammability = 4 
Reactivity = 3 

Personal Protection Code = x (Consult your 
supervisor or standard operating procedures 
for special handling directions.) 


HMIS RATING: 


NFPA RATING: 


Exposure Limits: 

OSHA 

ACGIH 


Health = 3 
Flammability = 4 
Reactivity = 3 


TWA (8 hr) 

1 ppm 
1 ppm 


STEL (15-min) 

5 ppm 
n/a 


PRIMARY ROUTES OF EXPOSURE : Inhalation; eye contact, skin 
contact/absorption 


SIGNS AND SYMPTOMS OF OVEREXPOSURE : Effects include 
skin, eye and respiratory tract irritation or burns. Central nervous 
system effects initially cause headache, dizziness and nausea and in 
extreme cases, unconsciousness and death. Peripheral nerve dam¬ 
age may result in muscular weakness, giddiness, irrational behavior 
and loss of sensation in the extremities. Dulling of the sense of smell 
may occur. 


ACUTE HEALTH EFFECTS: 

INHALATION : Inhaling concentrated vapor may cause serious 
health effects. Inhalation may progressively cause mucous mem¬ 
brane and respiratory irritation, headache, vomiting, cyanosis, drowsi¬ 
ness, weakness, in coordination, CNS depression, lachrymation, 
nasal discharge and salivation, gasping, and labored breathing. 
Delayed effects may include nausea, diarrhea, edema of the lungs, 
paralysis and convulsions. NOTE: Ethylene oxide has a high odor 
threshold (>250 ppm) and the sense of smell does not provide ade¬ 
quate protection against its toxic effects. 

EYE CONTACT: Liquid ethylene oxide is severely irritating and 
corrosive to the eyes and contact can cause swelling of the conjunc¬ 
tiva and irreversible corneal injury. Contact with liquid ethylene oxide 
can cause frostbite. Vapors may cause eye irritation, tearing, red¬ 
ness and swelling of the conjunctiva. 


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[OWNER’S MANUAL] 


SKIN CONTACT: Prolonged contact with liquid ethylene oxide can 
cause a local erythema, edema, and formation of blisters. Response 
is more severe on damp skin. There may be a latency period of 
several hours prior to the onset of symptoms. Ethylene oxide may 
be absorbed by the skin, and sustained contact may produce ad¬ 
verse effects such as headache, dizziness, nausea, and vomiting. 
Ethylene Oxide is a skin sensitizer and some individuals may suffer 
an allergic skin reaction. Skin contact may also cause allergic con¬ 
tact dermatitis in some exposed individuals. Liquid Ethylene oxide 
evaporates rapidly and may chill the skin causing frostbite. 

INGESTION: This relatively unlikely route of exposure is expected to 
cause severe irritation and burns of the mouth and throat, abdominal 
pain, nausea, vomiting, collapse and coma. Aspiration may occur 
during swallowing or vomiting, resulting in lung damage. 

CHRONIC HEALTH EFFECTS: 

SKIN CONTACT : Long term effects are unknown but are expected 
to be similar to acute effects of skin exposure. 

EYE CONTACT: Some cases of cataract formation have been re¬ 
ported. 

INHALATION: Respiratory irritation which can result in permanent, 
lung injury, chromosomal aberrations and peripheral neurotoxic 
effects with a numbing of the sense of smell. Cognitive and CNS 
impairment may result from long term exposures. 

INGESTION : May cause anemia, gastrointestinal irritation, effects 
on liver, kidneys, and adrenal glands. 

CARCINOGENICITY : 

OSHA classifies ethylene oxide as a cancer/ reproductive hazard 
and considers that, at excessive levels, ethylene oxide may present 
reproductive, mutagenic, genotoxic, neurologic and skin sensitization 
hazards. 

ACGIH classifies ethylene oxide as “A2”- suspected human carcino¬ 
gen. 

NTP classifies ethylene oxide as a known human carcinogen. 

IARC classifies ethylene oxide in Group 1 (carcinogenic to humans). 
NIOSH classifies ethylene oxide as a potential human carcinogen. 

Section 4 

First Aid Measures 


EYE CONTACT: Immediately flush eyes, including the entire sur¬ 
face of the eyes and under the eyelids, gently but thoroughly with 
plenty of running water for at least 15 minutes. Obtain medical atten¬ 
tion immediately. NOTE: Never wear contact lenses when work¬ 
ing with ethylene oxide. 

SKIN CONTACT: Immediately flush skin thoroughly with water for at 
least 15 minutes while removing contaminated clothing and shoes. 
Obtain medical attention immediately. Wash clothing before reuse 
and discard contaminated leather articles such as shoes and belts. 

INHALATION: Remove exposed person to fresh air. If breathing 
has stopped, give artificial respiration then have qualified personnel 
administer oxygen, if needed. Get immediate medical attention. 


INGESTION: If patient is conscious give plenty of water (minimum 
of two glasses) but DO NOT INDUCE VOMITING. This material is 
corrosive. Keep head lower than hips to avoid aspiration, should 
vomiting occur. Get medical attention immediately. 

MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE : 

Preexisting skin, eye and respiratory disorders; lung, blood, nervous 
system and peripheral nerve disorders. 

NOTE TO PHYSICIANS: Respiratory symptoms include nausea, 
vomiting and irritation of the nose and throat. Pulmonary edema 
may occur. Respiratory effects may be delayed. Consider oxygen 
administration. If a chemical burn is present decontaminate skin 
and treat as any thermal burn. No specific antidote is known, how¬ 
ever consider gastric lavage and administration of a charcoal slurry. 


Section 5 

Fire Fighting Measures 

FLASH POINT (TEST METHOD): 

Tag Closed Cup: -4F (-20C) 

FLAMMABLE LIMITS IN AIR (% BY VOLUME): 

Upper flammable limit: 100% 

Lower flammable limit: 3.0% (30,000 ppm) 

NEFA HAZARD RATING: 

Health: 3 Flammability: 4 Reactivity: 3 

AUTOIGNITION TEMPERATURE : 

804 F (429C); burns in the absence of air 

EXTINGUISHING MEDIA: Carbon dioxide, dry chemical or water 
spray for small fires. Water spray, polymer or alcohol resistant 
foams for large fires. Dilution of liquid ethylene oxide with 23 vol¬ 
umes of water should render it non-flammable. Dilution with 100 
parts water to one part of ethylene oxide vapor may be required to 
control build up of flammable vapors in closed systems. Water spray 
can be used to reduce intensity of flames to cool fire-exposed con¬ 
tainers and to dilute spills to render non-flammable. 

HAZARDOUS DECOMPOSITION PRODUCTS: Carbon monoxide 
and carbon dioxide. 

UNUSUAL FIRE AND EXPLOSION HAZARDS: Ethylene oxide is 
dangerously explosive under fire condition; it is flammable over an 
extremely large range of concentrations in air and burns in the ab¬ 
sence of oxygen. Liquid ethylene oxide is lighter than water (floats) 
and vapors are heavier than air and may travel along ground long 
distances to sources of ignition and then flash back. Containers 
should not be subject to temperatures hotter than 127F (52 C). 
Vapors are extremely flammable and are readily ignited by static 
charge, sparks and flames at concentrations above 3%. 


Section 6 

Accidental Release Measures 


PRECAUTIONS: Treat any ethylene oxide leak as an emergency. 
Evacuate all personnel from the area except those directly engaged 
in stopping the leak or in cleaning up. If an Anprolene ampoule is 
inadvertently dropped and activated before it is sealed inside of the 
sterilization liner bag, it will still take time for the ethylene oxide 


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[OWNER’S MANUAL] 


to diffuse out of the gas release bag and into the room. At one full 
minute after activation there is less than 1 ppm measured at a dis¬ 
tance of 18 inches from the gas release bag. In the case of a pre¬ 
mature activation the operator should immediately: 

. Place the Anprolene ampoule inside the sterilizer 
• Close the sterilizer door 
. Turn the power on; and 
. Press the button to the right of PURGE. 

This will cause the purge and ventilation pumps to turn on and 
evacuate the ethylene oxide from the sterilizer and exhaust it from 
the workspace. Allow a full 14 hour cycle before you open the door 
and remove the used Anprolene ampoule and dispose of it. 


Section 7 

Handling and Storage 

HANDLING AND STORAGE PRECAUTIONS: Have established 
handling and emergency response procedures in place prior to use. 
Make sure that the sterilizer is properly grounded. Protect contain¬ 
ers from physical damage and regularly inspect them for cracks or 
leaks. 

ENGINEERING CONTROLS: Ethylene oxide, a major fire hazard, 
can burn in the absence of oxygen. All electrical devices used in 
areas processing or handling ethylene oxide must be engineered 
and designed to the applicable local electrical/fire codes. Safe¬ 
guards can include designing electrical devices as explosion proof 
and/or intrinsically safe. ATTENTION: Ethylene oxide vapors are 
colorless and odorless above OSHA’S permissible exposure level. 
An air monitoring system and/or AirScan® badges are recom¬ 
mended to determine airborne exposure levels. 

STORAGE SEGREGATION: Store ethylene oxide in a cool, dry, 
well-ventilated area away from incompatible chemicals and sources 
of ignition. Store Anprolene® refill kits upright; do not drop and 
move in a carefully supervised manner. DO NOT STORE IN 
DIRECT SUNLIGHT. 

SHIPPING AND STORAGE CONTAINERS: (See 49 CFR 173.4) 

All Anprolene® refill kits containing ethylene oxide are packaged and 
shipped in accordance with the small quantities exemption under 49 
CFR 173.4(c) and DOT approval CA 9803005 issued April 9,1998. 


Section 8 

Exposure Controls/Personal Protection 


EX- 


POSURE LIMITS: 


OSHA ACTION LEVEL (8 HR. TWA) 
OSHA PEL (8 HR TWA) 

OSHA 15 MINUTE EXCURSION LIMIT 

ACGIHTLV/TWA 

IDLH: 


0.5 ppm 
1 ppm 

5 ppm; 9 mg/m3 
1 ppm; 1.8 mg/m3 
800 ppm 


EYE PROTECTION : NEVER WEAR CONTACT LENSES when 
working with ethylene oxide. 


VENTILATION: Install and operate general and local exhaust venti¬ 
lation systems powerful enough to maintain airborne levels of ethyl¬ 
ene oxide below the OSHA PEL in the worker’s breathing area. 

AAMI / ANSI ST41 Good Hospital Practice: Ethylene Oxide Steriliza¬ 
tion and Sterility Assurance Guidelines, Section 3.4 recommends a 
minimum of 10 room makeup air changes per hour. Emission con¬ 
trols must be in compliance with Federal, State and local regulations. 

OTHER PROTECTION : Sterilizer must be electrically grounded/ 
bonded. Practice good personal hygiene; always wash thoroughly 
after using this material. Do not eat drink or smoke in work area. 

Section 9 

Stability and Reactivity 


Boiling Point: 

50.9°F (10.5°C) 

Freezing Point 

-169° F (-111.7°C) 

Specific Gravity: 

0.871 at 20°C 

Vapor Pressure: 

1094 mm Hg@20°C 

Vapor Density (Air =1) 

1.5 

Solubility in Water: 

100% 

Molecular Weight: 

44.06 gms/mole 

Percent Volatile by Volume 

100% 

Evaporation rate (Butyl Acetate = 1) 

Not applicable 

PH: 

7, neutral (100 grams/ 

Appearance and Odor: 

liter in water) 

Colorless liquid or gas 

Log Octanol/Water 

Partition Coefficient (log Kow): 

with sweet ether-like 
odor. Odor threshold: 
261 ppm (detectable); 
600-700 ppm recogniz¬ 
able). 

-0.3 


STABILITY: Material is stable for extended periods in closed air¬ 
tight, pressurized containers at room temperature, under normal 
storage and handling conditions. Vapors may explode when ex¬ 
posed to common ignition sources. 

CONDITIONS TO AVOID: Storage at warm temperatures or any 
exposure of storage or shipping containers to hot temperatures. 
Prevent exposure to all sources of ignition such as heat, flame, 
lighted tobacco products, or electrical or mechanical sparks. 

HAZARDOUS DECOMPOSITION PRODUCTS: Ethylene oxide 
undergoes thermal decomposition to form carbon dioxide and carbon 
monoxide gases. 

Section 10 

Toxicological Information 


TOXICOLOGICAL-ACUTE INHALATION: LCso (1 hr. exposure) 

5748 ppm (male rat) 

4439 ppm (female rat) 

5029 ppm (rat - combined sexes) 


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[OWNER’S MANUAL] 


Various mammalian species exposed to lethal concentrations of 
ethylene oxide had symptoms of mucous membrane irritation, central 
nervous system depression, lacrimation, nasal discharge, salivation, 
nausea, vomiting, diarrhea, respiratory irritation, incoordination, and 
convulsions. 

TOXICOLOGICAL-CHRONIC INHALATION: Symptoms of chronic 
exposure are similar to those observed in acute studies, including 
lung, kidney and liver damage and testicular tubule degeneration in 
some species. Studies demonstrated neuromuscular effects as the 
most sensitive indicator of ethylene oxide over exposure. 

TOXICOLOGICAL-ACUTE DERMAL: No dermal LDso information 
is available on this product. It is expected to be corrosive to rabbit 
skin. 

TOXICOLOGICAL-CHRONIC DERMAL: No chronic dermal 
toxicity data are available on this product. 

TOXICOLOGICAL- EYE: No eye irritation animal data are available 
on this product. However, it is expected to extremely irritating to 
rabbit eyes. 

TOXICOLOGICAL-ACUTE INGESTION: The acute oral LDso for 
This product is; 72 mg/kg, rat 

TOXICOLOGICAL-CHRONIC INGESTION: The effects of chronic 
ingestion of this product are unknown 

CARCINOGENICITY: A recent assessment of available 
epidemiology studies related to ethylene oxide concluded that the 
evidence indicates that ethylene oxide does not cause heart disease, 
an excess of cancers overall, or brain, stomach or pancreatic cancers 
which were seen in some animal and isolated human studies. The 
findings with respect to leukemia and non-Hodgkins lymphoma are 
less definitive. While the majority of the evidence does not indicate 
that ethylene oxide causes these cancers, there are some suggestive 
trends. Longer follow-up of ethylene oxide workers is needed to 
better clarify these relationships. Two inhalation studies with rats 
demonstrated carcinogenic responses consisting of increased inci¬ 
dences of mono-nuclear cell leukemia, peritoneal mesotheliomas , 
and primary brain tumors. In 2-year inhalation studies with mice 
there was evidence of carcinogenic activity as indicated by dose- 
related incidences of benign or malignant neoplasms of the uterus, 
mammary gland, and hematopoietic system (lymphoma). 

MUTAGENICITY: While ethylene oxide has demonstrated, in epide¬ 
miological studies with exposed workers, an increased incidence of 
chromosomal aberrations and sister chromatid exchanges, the rele¬ 
vance of such effects to human health hazard evaluation is currently 
uncertain. In rodent studies, dose related exposure to ethylene oxide 
induces increases in numbers of adducts in DNA and hemoglobin. 
Laboratory studies with mice have shown that acute exposure to 
ethylene oxide at 300 ppm and above caused testicular injury as 
evidenced by concentration-related increased embryonic deaths 
following mating of exposed males to non-exposed females 
(Dominant-Lethal Test). 

NEUROTOXICITY: Effects are similar to those of acute (short term) 
exposure, namely headaches, nausea, diarrhea, lethargy, and 
irrational behovior. Muscle weakness, loss of sensation in the 
extremities and a reduction in the sense of smell and/or taste may 
also result. Studies on workers Indicate that CNS and cognitive im¬ 
pairment may result from chronic exposures to ethylene oxide. 


REPRODUCTIVE EFFECTS: Some limited epidemiological data 
suggests that women exposed to ethylene oxide have a greater 
incidence of miscarriages. A one-generation reproduction study in 
rats showed decreased number of pups at 100 ppm, but not at 33 
ppm. In a two-generation reproduction study involving exposure of 
rats to ethylene oxide vapor for 5 hrs/day, 5 days/week, there was 
parental toxicity at 33 ppm and 100 ppm. The no-observable effect 
concentration for adult toxicity, offspring effect and reproductive 
effect was 10 ppm. 

TERATOLOGY: Inhalation development toxicity studies with rats 
exposed to ethylene oxide vapor at concentrations of 50 ppm, 125 
ppm and 225 ppm showed that maternal toxicity occurred at 125 and 
225 ppm. Fetotoxicity, evidenced by reduced fetal body weight, 
occurred at all concentrations. At 225 ppm and to a lesser extent at 
125 ppm an increased incidence of skeletal variants was found. 
There was no evidence of embryotoxicity or malformations. 

TARGET ORGANS: Overexposure to this product may affect the 
skin, eyes, respiratory system, liver, kidneys, brain, blood, reproduc¬ 
tive system, and central nervous system. 

Section 11 

Ecological Information 


ECOTOXICOLOGICAL DATA: Ethylene oxide hydrolyzes to ethyl¬ 
ene glycol. Biodegradation of ethylene oxide occurs at a moderate 
rate after acclimation (3-5% degradation after 5 days; 52% after 20 
days). Biodegradation is expected in a wastewater treatment plant. 
Ethylene oxide has an estimated half-life in the atmosphere of 211 
days. A high adsorptivity in soil is expected. 

Section 12 

Disposal Consideration 


WASTE MANAGEMENT/DISPOSAL: Dispose used Anprolene 
ampoules, sterilization liner bags, indicators and accessories as you 
would ordinary trash. 

However, unused Anprolene ampoules containing ethylene oxide 
are a RCRA hazardous waste with waste code U115 (Commercial 
chemical product - listed for toxicity and ignitability). Unused 
Anprolene ampoules containing ethylene oxide may be incinerated in 
an approved hazardous waste incinerator or can be biologically 
treated in an approved facility. Unused Anprolene ampoules con¬ 
taining ethylene oxide are banned from land disposal. 

Dispose of waste materials in accordance with all applicable Federal, 
State and local laws and regulations. 

Section 13 

Transport Information 


TRANSPORTATION DATA : 

DOT Proper shipping Name: 
DOT Class or Division: 
Identification Number 
Packing Group: 

DOT Label: 

DOT Packaging 

DOT Approval: 


Ethylene Oxide 
2.3 (Poison Gas) 

UN 1040 
n/a 

“This package conforms to 49 CFR 
173.4” 

See section 7, “Handling and stor 
age” 

CA-9803005 


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Section 14 

Regulatory Information 
U.S. REGULATIONS : 

TSCA status: Listed 

CERCLA Section 103 (40 CFR 302.4): listed 
10 lb. Reportable Quantity 
SARA Section 304 (40 CFR 356.40): Listed 
1 lb Reportable Quantity 

SARA Section 311/312 (40 CFR 370.21) Hazard categories met: 

Acute, Chronic, Fire, Reactive, Sudden Release 
SARA Section 313 (40 CFR 372.65); Listed 
OSHA (29 CFR 1910.1200): Meets criteria as a hazardous material 
OSHA (29 CFR 1910.1047): Ethylene Oxide Standard 
EPA list of Hazardous Air Contaminants: Listed 
EPA Organic Hazardous Air Pollutant (HAP) list: Listed 
EPA list of Pesticide Chemicals (40 CFR 180.151): Listed 
EPA NESHAPS (40 CFR 63.360) 

VOC Rule: 100% VOC 

STATE RIGHT-TO-KNOW REGULATIONS : 

California Proposition 65: Listed; cancer hazard; reproductive hazard 
California Director’s List: Listed 
Florida Hazardous Substance List: Listed 
Massachusetts Extraordinarily Hazardous Substance List: Listed 
Minnesota Hazardous Substance List: Listed 
New Jersey Hazardous Substance List: Listed on 0882 
(Special Hazardous Substance: Environmental 
Hazardous Substance) 

Pennsylvania Right-to-know List: Listed 


Section 15 
Other Information 


GLOSSARY OF TERMS AND ABBREVIATIONS : 

ACGIH-American Conference of Governmental Industrial Hygienists 
CERCLA- Comprehensive Environmental Response, Compensation 
and Liability Act. 

CAS- Chemical Abstract Service 

CFR- Code of Federal Regulations 

CNS- Central Nervous System 

DOT- U.S. Department of Transportation 

EPA- U. S. Environmental Protection Agency 

HMIS- Hazardous Materials information Sheet 

IARC- International Agency for Research on Cancer 

IDL- ingredient Disclosure List 

IDLH- Immediately dangerous to life and health 

HAP- Hazardous Air Pollutant 

LCso - Median lethal dose that kills 50% of an exposed population by 
the inhalation route 

LDso- Median lethal dose that kills 50% of an exposed population by 
the oral (or dermal) route 

NESHAPS- National Emission Standards for Hazardous Air Pollut¬ 
ants 

NFPA- National Fire Protection Association 

NIOSH- National Institute of Occupational Safety and Health 

NTP- National Toxicology Program 


OSHA- Occupational Safety and Health Administration 

p/p- parts per part 

PEL- Permissible exposure Limit 

PVC- Polyvinyl chloride 

ppm- Parts per million 

p.s.i.g- Pounds per square inch (gauge pressure) 

RCRA- Resource, Conservation and Recovery Act 

SARA- Superfund Amendment and Reauthorization Act of 1990 

STEL- Short-term exposure Limit 

TDG-Transportation of Dangerous Goods 

TLV- Threshold Limit Value 

TSCA- Toxic Substance Control Act 

TWA- Time Weighted Average 

VOC- Volatile organic compound 

WHMIS-Workplace Hazardous Material Information System 


MSDS Revision Date: 10/23/02 


Disclaimer 

It is imperative that the user/reader be familiar with and adhere to 
OSHA regulations which are specific to ethylene oxide 
(29CFR1910.1047) as well as any other applicable Federal, State, or 
local government regulations. Regulations listed in Section 14 of this 
document may not be all inclusive and are subject to change. The 
data in this MSDS is furnished gratuitously independent of any sale 
of the product only for your investigation and independent verifica¬ 
tion. While the information is believed to be correct, Andersen 
makes no representation as to the accuracy of the information con¬ 
tained herein. Andersen shall in no event be responsible for any 
damages of whatsoever nature directly or indirectly resulting from 
publication or use of, or negligence upon data contained herein. No 
Warranty (either expressed or implied) of merchantability or of fitness 
for any purpose with respect to the product or to the data herein is 
made hereunder 


MSDS Revision Date: 9/08/04 


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APPENDIX G 

V__ J 


AN74 i/ix Specifications 


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APPENDIX H 


Equipment Ratings Summary and 
Replacement Parts List 


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APPENDIX G 

Equipment Ratings Summary 


Equipment Rating 


Model Ref. 


Voltage 

Hz. 

Power 

Fuse Rating 

AN74.67 

AN74/ 

115v +/- 10% 

50/60 

150 Watts 

2 Amp. 

AN74.68 

AN74/ 

230v +/- 10% 

50/60 

150 Watts 

2 Amp. 

AN74.69 

AN74/ 

lOOv +/- 10% 

50/60 

150 Watts 

2 Amp. 

AN74.87 

AN74/JC 

115 v +/- 10% 

50/60 

150 Watts 

2 Amp. 

AN74.88 

AN74/ 

230v +/- 10% 

50/60 

150 Watts 

2 Amp. 

AN74.89 

AN74/X 

lOOv +/- 10% 

50/60 

150 Watts 

2 Amp. 


Environmental Conditions 


The Anprolene Sterilizers are designed to function in an environment with these conditions: 

i. Indoor use; 

ii. Altitude up to 6,562 feet (2000 meters); 

iii. Temperature 68°F (20° C) to 91°F (33° C); 

iv. Maximum relative humidity 80% for temperatures up to 87.8° F (31 0 C) 
decreasing linearly to 50% relative humidity at 104°F (40° C); 

v. Mains supply voltage fluctuations not to exceed ±10% of the nominal voltage; 

vi. Transient overvoltages according to INSTALLATION CATEGORY 
(OVERVOLTAGE CATEGORY) II: Local level, appliances, portable 
equipment, etc. capable of withstanding 1500 volts impulse; 

vii. POLLUTION DEGREE 2 in accordance with EC 664. 

Connections 

Nominal voltage depending upon model selected connected to a grounded, un-switched 
power supply. 


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Anprolene Sterilizers Replacement Parts List 


This list relates to Models: 


AN74/ Model: AN 74.67 
AN74/ Model: AN 74.68 
AN74/ Model: AN 74.69 


AN74/x Model: AN74.87 
AN74ix Model: AN74.88 
AN74/x Model: AN74.89 


Part No, 


Description 


AN 100.04 Purge Tube Bobbin Assembly 

7489 Populated Circuit Board Assembly (version AICUEG) 

2929 Blue hose .250" OD, .125 ID 

3875 .125" Brass Hose Barb 

3876 90° Brass Elbow 
4710 Check Valve 3" of H20 

7409 Strap, Velcro, Hook and Loop, 10" Long x 1" Wide 

7433 Tubing, 1/2" OD, 3/8" ID, Ester Based, Poly 

7434 Tubing, FP, 3/8" OD, 1/4" ID 

7441 Plastic Single Barb Fittings, 3/8" ID, 1/8" NPT 
7443 Acetal Union Tee, 1/2" OD 

7445 Acetal Bulkhead Union, 3/8" 

7446 Acetal Bulkhead Union, 1/2" 

7448 Female Elbow Adapter, 1/2" OD, 3/8" NPT (AN 74.69) 

7449 Acetal Stem Adapter, 1/2" OD to 3/8" NPT (AN 74.69) 

7450 Insert, 1/2" OD Tube 

7451 Rubber Tubing, 5/8" ID with 1/8" Wall, Amber 

7452 Pump, Thomas 6025SE, 100VAC, 50 Hz, 150070 

7453 Pump, Thomas 6025SE, 115VAC, 60 Hz, 150057 
87455 Switch, Momentary Action, Push Button 

7456 D Series Miniature Power Rocker Switch, SPDT 

7458 Fuse, Buss ABC-2, 250V, 1/4" x 1 1/4", 2 Amp, Fast Acting 

7460 Power Cord (AN 74.67 and AN 74.69) 

7461 Cable, Single-Row Receptacle, Housing to Solder Type, 16 PIN, 4"L 
7464 LED Backlight, Optrex LCD 4 x 20 

7468 Magnetic Proximity Sensor, Recessed, 3/8" Magnet Included 

7491 Fuse Holder Receptacle 

7493 Fuse Drawer (AN 74.67 and AN 74.69) 

74012 Exhaust outlet 

74013 90° Exhaust Insert 

74014 Gauge, 30 In. of H20 

74015 Nipple, Brass with Hose 
74017 .020" Aluminum Orifice 
74022 .020" Gray PVC Orifice 
74027 12v DC Cooling Fan 
802741 Vacuum Switch (VS0.19) 

802742 Vacuum Switch (VS4.0) 


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APPENDIX I 


Andersen One Year Limited Warranty 


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ANDERSEN One-Year Limited Warranty 

Andersen Products, Inc. (“Andersen”) warrants that this Anprolene© Sterilizer (“Product”) is free from defects in mate¬ 
rial and workmanship that result in Product failure during normal usage, according to the following terms and condi¬ 
tions: 

1. The limited warranty for the Product extends for ONE (1) year beginning on the date of the purchase of the Product. 

2. The limited warranty extends to the original purchaser of the Product (“Consumer”) and is not assignable or trans¬ 
ferable to any subsequent purchaser/end-user. 

3. The limited warranty extends only to Consumers who purchase the Product in the United States, Canada and Ja¬ 
pan, Mexico, Central and South America and the Caribbean. 

4. During the limited warranty period, Andersen will repair, or replace, at Andersen's option, any defective parts, or any 
parts that will not properly operate for their intended use with new or factory rebuilt replacement items if such repair or 
replacement is needed because of product malfunction or failure during normal usage. No charge will be made to the 
Consumer for any such parts. Andersen will also pay for the labor charges incurred by Andersen in repairing or re¬ 
placing the defective parts. The limited warranty does not cover defects in appearance that are cosmetic or decorative. 
Andersen's limit of liability under the limited warranty shall be the actual cash value of the Product at the time the Con¬ 
sumer returns the Product for repair, determined by the price paid by the Consumer for the Product less a reasonable 
amount for usage. Andersen shall not be liable for any other losses or damages. These remedies are the Consumer’s 
exclusive remedies for breach of warranty. 

5. Upon request from Andersen, the Consumer must prove the date of the original purchase of the Product by a dated 
bill of sale or dated itemized receipt. 

6. The Consumer shall bear the cost of shipping the Product, or any part thereof, to Andersen in Haw River, North 
Carolina. Andersen shall bear the cost of shipping the Product, or any part thereof, back to the Consumer after the 
completion of service under this limited warranty. 

7. The Consumer shall have no coverage or benefits under this limited warranty if any of the following conditions are 
applicable: 

a) The Product has been subject to abnormal use, abnormal conditions, improper storage, exposure to moisture or 
dampness, unauthorized modifications, unauthorized connections, un-authorized repair, misuse, neglect, abuse, acci¬ 
dent, alteration, improper installation, or other acts which are not the fault of Andersen, including damage caused by 
shipping. 

b) The Product has been damaged from external causes such as collision with an object, or from fire, flooding, sand, 
dirt, windstorm, lightning, earthquake or damage from exposure to weather conditions, an Act of God, or theft, blown 
fuse, or improper use of any electrical source, or damage caused by the connection to other products not recom¬ 
mended for interconnection by Andersen. 

c) Andersen was not advised by the Consumer in writing of the alleged defect or malfunction of the Product within 
fourteen (14) days after the expiration of the applicable limited warranty period. 

d) The Product serial number plate has been removed, defaced or altered. 

8. If a problem develops during the limited warranty period, the Consumer shall take the following step-by-step proce¬ 
dure: 

a) The Consumer shall contact the place of purchase to describe the alleged defect or malfunction of the Product and 
obtain a Return Authorization Number (“RMA”) 

b) The Consumer shall return the Product to the place of purchase for repair or replacement processing. 

c) If “b” is not convenient because of distance (more than 100 miles) or for other good cause, the Consumer shall ship 
the Product prepaid and insured to: 

Andersen, Products, Inc. 

Attn: Repair Department 
3202 Caroline Drive 
Health Science Park 
Haw River, NC 27258 USA 

d) The Consumer shall include a return address, daytime phone number and/or fax number, complete description of 
the problem, proof of purchase and service agreement (if applicable). Expenses related to removing the Product from 
an installation are not covered under this limited warranty. 

e) The Consumer will be billed for any parts or labor charges not covered by this limited warranty. The Consumer will 
be responsible for any expenses related to reinstallation of the Product. 

f) Andersen will repair or authorize the repair of the Product under the limited warranty within 15 days after receipt of 
the Product by Andersen or an Andersen authorized service center. If Andersen cannot perform repair covered under 
this limited warranty within 15 days, or after a reasonable number of attempts to repair the same defect, Andersen at 
its option, will provide a replacement Product or refund the purchase price of the Product less a reasonable amount for 
usage. 


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g) If the Product is returned to Andersen during the limited warranty period, but the problem with the Product is not 
covered under the terms and conditions of this limited warranty, the Consumer will be notified and given an esti¬ 
mate of the charges the Consumer must pay to have the Product repaired, with all shipping charges billed to the 
Consumer. If the estimate is refused, the Product will be returned freight collect. If the Product is returned to Ander¬ 
sen after the expiration of the limited warranty period, Andersen's normal service policies shall apply and the Con¬ 
sumer will be responsible for all shipping charges. 

9. The Product consists of newly assembled equipment that may contain used components that have been reproc¬ 
essed to allow machine compliance with Product performance and reliability specifications. 

10. ANY IMPLIED WARRANTY OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OR 
USE, SHALL BE LIMITED TO THE DURATION OF THE FOREGOING LIMITED WRITTEN WARRANTY. OTHER¬ 
WISE, THE FOREGOING LIMITED WARRANTY IS THE CONSUMER'S SOLE AND EXCLUSIVE REMEDY AND 
IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. ANDERSEN SHALL NOT BE LIABLE FOR 
SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO, LOSS OF AN¬ 
TICIPATED BENEFITS OR PROFITS, LOSS OF SAVINGS OR REVENUE, PUNITIVE DAMAGES, LOSS OF 
USE OF THE PRODUCT OR ANY ASSOCIATED EQUIPMENT, COST OF CAPITAL, COST OF ANY SUBSTI¬ 
TUTE EQUIPMENT OR FACILITIES, DOWN-TIME, THE CLAIMS OF ANY THIRD PARTIES, INCLUDING 
CUSTOMERS, AND INJURY TO PROPERTY, RESULTING FROM THE PURCHASE OR USE OF THE PROD¬ 
UCT OR ARISING FROM BREACH OF THE WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, STRICT 
TORT, OR ANY OTHER LEGAL OR EQUITABLE THEORY, EVEN IF ANDERSEN KNEW OF THE LIKELIHOOD 
OF SUCH DAMAGES. ANDERSEN SHALL NOT BE LIABLE FOR DELAY IN RENDERING SERVICE UNDER 
THE LIMITED WARRANTY, OR LOSS OF USE DURING THE PERIOD THAT THE PRODUCT IS BEING RE¬ 
PAIRED. 

11. Some countries do not allow limitation of how long an implied warranty lasts, so the above one-year warranty 
limitation may not apply to you (the Consumer). Some countries do not allow the exclusion or limitation of incidental 
and consequential damages, so certain of the above limitations or exclusions may not apply to you (the Con¬ 
sumer). This limited warranty gives the Consumer specific legal rights and the Consumer may also have other 
rights which vary from country to country. 

12. Andersen neither assumes nor authorizes any authorized service center or any other person or entity to as¬ 
sume for it any other obligation or liability beyond that which is expressly provided for in this limited warranty includ¬ 
ing the provider or seller of any extended warranty or service agreement. 

13. This is the entire warranty between Andersen and the Consumer, and supersedes all prior and contemporane¬ 
ous agreements or understandings, oral or written, and all communications relating to the Product, and no repre¬ 
sentation, promise or condition not contained herein shall modify these terms. 

14. This limited warranty allocates the risk of failure of the Product between the Consumer and Andersen. The allo¬ 
cation is recognized by the Consumer and is reflected in the purchase price of the Product. 

15. Any action or lawsuit for breach of warranty must be commenced within eighteen (18) months following delivery 
of the Product to the Consumer. 

16. Questions concerning this limited warranty may be directed to: 

Andersen Customer Care Center 

Andersen Products, Inc. 

3202 Caroline Drive 
Health Science Park 
Haw River, NC 27258 
Telephone: 1-800-523-1276 
Facsimile: (336) 376-8153 
E-mail: customerservice@anpro.com 

17. The limited warranty period for Andersen supplied attachments and accessories is specifically defined within 
their own warranty cards and packaging. 

Anprolene© is a registered trademark of Andersen Products, Inc. 


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APPENDIX J 


10 Year Useful Life of Sterilizer 


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APPENDIX J 
10 Year Useful Life 

J.1.1 The Useful Life of the Andersen AN74i and AN74iX sterilizers is ten (10) years 
from the date of manufacture. The Lot/Serial Number on the back of the sterilizer indicates 
the year the sterilizer was manufactured. For example, the first two numbers of the Lot/ 
Serial Number 233508 indicate that the sterilizer was manufactured in the year 2003. Useful 
Life refers to the time period during which Andersen Sterilizers will maintain a spare parts 
inventory and provide services to repair and support your sterilizer. Useful Life also refers 
to the time period, after which the sterilizer should be removed from service and replaced 
with a newer sterilizer. 

J. 1.2 If your sterilizer is in need of repair after the Limited One Year Warranty Period has 

expired and prior to the expiration of the Useful Life, you should contact your Andersen 
Customer representative at 800-523-1276 if you are located in the United States or Canada. 
If you are located outside of these two countries you should contact your local distributor. 


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Manufactured by: 

Andersen Sterilizers, Inc. 

Health Science Park 

3154 Caroline Drive 

Haw River, NC 27258-9789 USA 

Tel 336-376-8622 

Fax: 336-376-5428 


Distributed by: 

Andersen Products, Inc. 

Health Science Park 

3202 Caroline Drive 

Haw River, NC 27258-9789 USA 

Tel: 800-523-1276 

Fax: 336-376-8153 

E-mail: customerservice@anpro.com 


Andersen Sterilizers, Inc. reserves the right to correct typographical errors. Specifications are sub¬ 
ject to change. Nothing in this manual may be reproduced in any manner, either wholly or in 
part, for any use without prior written permission from Andersen Sterilizers, Inc. 

Anprolene®, Humidichip®, Seal and Peel®, Dosimeter®, and Steritest® are registered trademarks of 
Andersen Products, Inc. 

AirScan® is a registered trademark of AirScan Enviromental Technologies, Inc. 

Velcro® is a registered trademark of Velcro Industries B.V. 


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