ANPRO Andersen Products EcoGas 3 Sterilizer User Manual

EOGas™ Series Plus Owner’s Manual ®

OWNER’S MANUAL Multiload Ethylene Oxide Sterilization

SERIES 3

sterilization redefined

Andersen Sterilizers, Sterilizers , Inc. Health Science Park Haw River, NC 27258 USA AN ISO 9001 - EN46001 certified company

6 0 3 0 5 0 4 0 0 4 N P

EOGas™ Series Plus Owner’s Manual

Andersen Sterilizers, Inc. reserves the right right to correct typographical typographical errors. Specifications are subject 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.

is a registered trademark of Andersen Sterilizers, Inc.: ®

is a registered AirScan Enviromental Technologies, Technologies, Inc.

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EOGas™ Sterilizers Sterilizers - Series 3 Plus Owner’s Manual Manufactured and Distributed Distribut ed by:

Andersen Sterilizers, Sterilizer s, Inc. Health Science Park 3151 Caroline Drive Haw River, NC 27258 USA

US Distributor: Distrib utor:

Andersen Products, Inc. Health Science Park 3202 Caroline Drive Haw River, NC 27258 USA

European Distributor: Distribut or:

H.W. Andersen Products, Ltd. Davy Road Clacton-On-Sea Essex CO15 4XA UK

This manual applies to models: AN 306.01 AN 306.11

110/120V 110/120V - 50/60Hz 50/60Hz 220/240V 220/240V - 50/60Hz 50/60Hz

AN 310.01 AN 310.11

110/120V 110/120V - 50/60Hz 50/60Hz 220/240V 220/240V - 50/60Hz 50/60Hz

See identity plate on each unit. Technical assistance may be obtained from the Manufacturer: Andersen Andersen Sterilizers, Inc. Health Science Park 3151 Caroline Drive Haw River, NC 27258 USA Phone: 336-376-8622 Fax: 336-376-3088

UL Std. No. 3101-1 CSA C22.2 No. 1010.1-92 IEC Std. 1010-1 National Certification Body - CSA LR 25596-17

The user should be aware that if the EOGas sterilizer is installed and operated in a manner not specified by the company the protection provided by the equipment may be impaired. The specifications contained in this manual are subject to change without notice. 3


INTRODUCTION This manual provides an overview of the installation, operation, and maintenance requirements of EOGas Series 3 Plus Sterilizers, and the information necessary for troubleshooting, testing, and repairing the sterilizer cabinets and heat sealer. EOGas Series 3 Plus is a sterilization system manufactured by Andersen Sterilizers, Inc. Its components include:

The EOGas sterilizer cabinet

Andersen AN5026 Vacuum Vacuum Sealer

EOGas Base Cabinet EOGas cartridges Dosimeters®

Humidichip® relative humidity stabilizing chips

EOGas sterilization bags 4


The EOGas system uses 100% Ethylene oxide gas in sealed cartridges. Items to be sterilized are prepared, wrapped, and placed inside a sterilization bag along with the appropriate size EOGas cartridge, a Humidichip relative humidity stabilizer chip and an EOGas Dosimeter. After the sterilization bag is sealed, the gas is released inside the sterilization bag by activating the cartridge through the bag wall. The standard sterilization cycle takes 16-hours. EOGas Series 3 Plus sterilizers have three different operating modes - STANDARD, BATCH, and INDUSTRIAL - enabling operators to choose the most efficient mode for their sterilization needs.

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CONTENTS INSTALLATION……………………………………………………………………..8 Unpacking…………………………………………………………………………...9 Initial Setup………………………………………………………………………….8 Installation Requirements………………………………………………………….10 Power Failure……………………………………………………………………….11 Label Printer Connection………………………………………………………….12 PROCESSING REVIEW……………………………………………………..……13 REVIEW……………………………………………………..……13 Disassembly………………………………………………………………………...13 Cleaning……………………………………………………………………………..13 Humidifying………………………………………………………………………….14 Drying………………………………………………………………………………..15 Wrapping…………………………………………………………………………….15 Description of an EOGas Cycle…………………………………………………..16 EOGAS STERILIZER OPERATION……………………………………………..20 OPERATION……………………………………………..20 Setting Sterilization Parameters and Operating Modes …………………...21 Setup Screens ……………………………………………………………………..21 Changing Parameters under the Supervisor Code …………………………….22 Calibrating Temperature under the Technician Code…………………………..24 Operating the Sterilizer ………………………………………………………….26 Preconditioning Cycle……………………………………………………………26 Cycle……………………………………………………………26 Standard Operating Mode (STNDRD)…………………………………………29 (STNDRD)…………………………………………29 Loading the Sterilizer in Standard Operating Mode ……………………………29 Unloading the Sterilizer in Standard Operating Mode …………………………33 Extended Aeration………………………………………………………………….36 Batch Mode (BATCH) …………………………………………………….………37 Loading the Sterilizer in Batch Mode…………………………………….……….37 Unloading the Sterilizer in Batch Mode…………………………………………..39 Extended Aeration………………………………………………………………….41 Industrial Mode (INDUSTRIAL…………………………………………………..42 (INDUSTRIAL…………………………………………………..42 Emergency Unloading …………………………………………………………..44 Standard Mode Supervisor Unload ……………………………………………...44 Batch Mode Supervisor Unload ………………………………………………….46 Power Outage………………………………………………………………………47 Operation of the Label Printer…………………………………………………….48 Replacing the Roll of Label Paper ………………………………………………..49 Operation of the Panel-Mounted Printer…………………………………………51 Standard Cycle Sample Printout ………………………………………………...51

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Batch Cycle Sample Printout………………………………………………………….52 Industrial Cycle Sample Printout ……………………………………………………..52 Changing the Paper Roll………………………………………………………………53 Ribbon Cartridge Replacement ……………………………………………………...54 MAINTENANCE AND TROUBLESHOOTING…………………………...………...55 TROUBLESHOOTING…………………………...………...55 Alarms…………………………………………………………………………………..56 Alarms…………………………………………………………………………………..56 EOGAS Sterilizing Chamber ………………………………………………………..58 ………………………………………………………..58 HEPA Filter Replacement…………………………………………………………...58 Replacement…………………………………………………………...58 Abator and Exhaust Assembly……………………………………………………..59 Assembly……………………………………………………..59 Maintenance…………………………………………………………………………….59 Exhaust Blower…………………………………………………………………………59 Vacuum Sealer ………………………………………………………………………...60 ………………………………………………………………………...60 Circuit Breakers……………………………………………………………………….61 Breakers……………………………………………………………………….61 Door Adjustment………………………………………………………………………62 Adjustment………………………………………………………………………62 Door Gasket Replacement…………………………………………………………….62 Battery Replacement…………………………………………………………………63 Replacement …………………………………………………………………63 Fuse Replacement……………………………………………………………………64 Replacement……………………………………………………………………64 Manual Door Unlock………………………………………………………………….66 Unlock………………………………………………………………….66 Component Module Replacement Replacement…………………………………………………67 …………………………………………………67 ETHYLENE OXIDE SAFETY…………………………………………………………71 SAFETY…………………………………………………………71 APPENDIX APPENDIX Diagrams and Drawings Figure 1 EOGas Sterilizer Operation Reference Chart Figure 2 Sterilizer Dimensions Figure 3 Heat Sealer Figure 4 Vacuum Sealer Figure 5 Venting Through Outside Wall Figure 6 Venting to the Outside within an Interior Wall Figure 7 Exhaust Calculations Figure 8 Component Module Layout Figure 9 EOGas Extractor Unit Figure 10 Gas Disposal System Figure 11 Equipment Ratings Summary Figure 12 Controls Layout Figure 13 Ventilation Alarm Schematic Figure 14 Electrical Schematic 120 V Figure 15 Electrical Schematic 240 V Figure 16 Replacement Parts List Figure 17 IEC Warning Symbols Figure 18 Routine Maintenance Schedule Material Safety Data Sheets............... Sheets ............................. ........................... .......................... ........................... .....................92 .......92 Andersen One-Year Limited Warranty................ Warranty.............................. ............................ .......................... ...............98 ...98 7


EOGas Sterilizer Installation

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INSTALLATION INSTRUCTIONS Unpacking Remove the sterilizer steriliz er from the shipping crate. Look for the following items: Exhaust Blower Exhaust Hose Uninterruptible Power Supply (UPS) for units without an abator Label Printer Power Cable Spare Fuses Cabinet Positioning When mounted on a base unit, EOGas Sterilizer Cabinets are freestanding on casters with brakes. After positioning the cabinet, the two front casters can be used to lock the cabinet in place. Alternatively, Alternativel y, the cabinet may be mounted on a bench, without a base unit. Position the cabinet and lock in place if desired. desired. If an Abator will be used, skip to the paragraph below on p. 9 titled "Abator Connection". Exhaust Blower Connection The Exhaust Blower is connected with an Exhaust Hose to the EOGas Sterilizer Cabinet. The Exhaust Blower should be mounted on the inside of an outside wall to minimize the length of ductwork needed. Mount the unit high o on n the wall to allow the exhaust hose to hang freely.

Mounted Exhausted Blower

Connect the blue Exhaust Blower hose to the cabinet exhaust outlet. Attach the flange with four screws to the to top cover. 9


Mount the Uninterruptible Power Supply (UPS) to the back of the cabinet.

Connect the power cord of the Exhaust Blower to the output receptacle on the UPS.

Abator Connection If the EOGas sterilizer is provided with an Abator, the hose from the cabinet to the Abator and the Abator Exhaust must be connected. The Abator exhaust blower must be operating before proceeding to "Setting Sterilization Parameters and Operating Modes" (p. Modes" (p. 20) under "EOGas Sterilizer Operation." Abators require require space space for both the Abator Abator unit and and Exhaust Exhaust Blower. The induction-typ induction-type e Exhaust Blower should be mounted at the end of the exhaust ducting, and care should be taken to eliminate all leaks in the ductwork. The Abator and Exhaust Blower may be mounted on the roof or any location that will allow access for maintenance and changing the catalyst. The Abator weighs 385 pounds (175 kilos) and the Exhaust Blower 65 pounds (30 kilos). The Abator Abator unit does not require a power connection. The Exhaust Blower requires an independent power supply, preferably one that will not be subject to power outage.

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Power Requirements The EOGas Cabinet is fitted with a 5 ft. (1.5m) grounded three prong power cord. The power requirements are 120V/60Hz 15 Amp (U.S.), 220V/50Hz 8Amp (Europe), or 220V/60Hz 10 Amp (Korea). A dedicated dedicated circuit, separately separately fused and and connected connected to a standby power supply supply is required. required. Clearance of at least 28" (71cm) is necessary in front of the cabinet door. A clearance of 2 feet (61cm) above the cabinet is recommended. Power Connection Connect the EOGas Sterilizer power cord to the power outlet. A dedicated power outlet that has standby power is required. Incoming power fuses are installed in the cabinet power receptacle. Spare fuses for 110V models are enclosed in the recap receptacle and with the Owners Manual (see p. 65 for information on "Fuse Replacement"). Power Failure The EOGas Series 3 Plus computer has a standby power supply to retain package numbers and sterilization cycle information in microprocessor memory. During a power outage the microprocessor prevents access to the cabinet. (See page 68 "Manual Door Unlock" for emergency unlocking). During a power failure the cabinet heaters and the circulating fan do not operate. The ventilation unit will continue to ventilate the cabinet from the standby power supply. When power is restored, the time of day the power outage occurred is printed. Sterilization cycle time is extended to take into account the time the power was disconnected. The display will return to normal, showing "Warming Up" and the current temperature. The low temperature alarm will not sound after power restoration while the temperature in the cabinet returns to operating temperature (50ºC).

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Label Printer Connection Attach the Label Printer Printer mounting mounting bracket to the cabinet with the two three-eared screws Three-eared screw

and attach the Label Printer Enclosure to the mounting bracket at the top and bottom locations with the three-eared screws provided.

Three-eared screw

Connect the Printer Data and Printer Power cables to the connections on the side of the cabinet (see p. 47 for "Operation of the Label Printer"). Printer" ).

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PROCESSING REVIEW Material to be sterilized by ethylene oxide (EOGas) must be meticulously cleaned and dried. Coatings of dry protein like dry pus, blood, or feces, protect microorganisms and slow the sterilization process. You must always be sure to take the following precautions before sterilizing with EOGas: Disassembly EOGas diffuses readily through many materials. However, occlusive caps, plugs or stylets must be removed from instruments so that the gas can penetrate penetrate freely. Syringes must be disassembled for sterilization. Batteries must be removed from electrical devices and sterilized separately to prevent electrical sparks.

Cleaning Disassemble and scrub all instruments in detergent and water to the most critical standard of cleanliness possible.

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Humidifying If cleaning in water will damage the items to be sterilized, sterili zed, pretreat for 4 hours in a sterilization sterili zation bag having saturated humidity. To humidify the contents of the sterilization bag, wrap the items individually in paper or cloth in the usual manner. Place them in a sterilization bag along with a Humiditube™, Humidichip®, Dosimeter® and an EOGas cartridge (Remove the cartridge trigger guard but DO NOT ACTIVATE CARTRIDGE). Complete the provided Dosimeter card before before placing it in the sterilization sterili zation bag. Use Color Change Indicators, if desired, for further visual assurance at the end of a cycle of exposure to Ethylene oxide.

Heat seal the sterilization bag.

Start a Preconditioning Cycle as shown in the "Preconditioning "Preconditioning Cycle" Cyc le" section section of the manual, page 25. After the Preconditio Preconditioning ning Cycle, Cycle, remove the the bag from from the sterilizer. sterilizer. It may then then be placed placed in the sterilizer cabinet for a normal-length, 16 hour sterilization cycle.

AN1072 Humiditube The AN1072 Humiditube provides a barrier from any surrounding product, while allowing adequate and full release of AN1071 Humidichip moisture. The tube does not absorb Ethylene oxide or affect the sterilization and aeration process. AN1071 Humidichips ensure Humidichips ensure that humidification requirements for Ethylene oxide sterilization are met. The AN1071 Humidichip measures 2" x 2" (51mm x 51 mm) and contains at least 4 gms of water. One Humidichip per sterilization bag per cycle is sufficient for standard humidification needs. Increase the number of Humidichips to two if the load contains primarily dry cotton or paper. 14


AN1087 Dosimeters Dosimeters are are designed to change color from yellow to blue when exposed to Ethylene oxide. They integrate the effects of of time, temperature and the concentration of Ethylene oxide in contact with the crystals in the capillary tube. For a load to be considered sterile, the color change from yellow to blue must extend past the triangular mark on the label. No laboratory testing is required. The information is available immediately immediat ely at the end of a sterilization cycle. AN85 Color Change Indicators indicate Indicators indicate exposure to Ethylene oxide gas by turning color from yellow to blue. They show that there has been exposure to Ethylene oxide but they do not indicate the actual dose. The convenient self-stick self-sti ck backing adheres to conventional paper or cloth wrapping, or to Seal and Peel® transparent plastic packaging. Drying Be sure that items to be sterilized are physically dry before wrapping and processing. Towel drying or drain drying is sufficient. Do not use hot air drying. Water on instruments at the time of exposure to EOGas may react with the gas and reduce its effectiveness. Hollow bore needles and plastic or rubber tubing must be open and free from stylets and plugs. Syringes must be packaged disassembled with their plungers out of of the barrel.

Wrapping All items to be be sterilized sterilized must be wrapped in cloth or paper paper in the manner convention conventional al for steam sterilization or in ANPRO Seal and Peel® Packaging. Packaging. ANPRO Seal and Peel packaging provides a transparent, peel-open, extended shelf life package, compatible with the EOGas sterilization system. No other plastic film packaging material may be used with EOGas unless it has been tested and adequate ethylene oxide gas permeability has been demonstrated. Polyamide (Nylon) and polyester (Mylar) films are known to be impermeable to EOGas. Do not pack the sterilization sterili zation bag so tightly with cloth or gauze gauze that gas diffusion is slowed.

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Description of an EOGas Cycle Prepare items to be sterilized as described under "Processing Review" on p. 12. Press the LOAD key on the front of the EOGas sterilizer cabinet and follow the directions for loading. Remove a Dosimeter card from the dispenser box. Write Writ e the date and the time sterilization and aeration will be complete on the card. Take a sterilization bag from the EOGas dispenser box and place the wrapped items into the sterilization bag, along with one AN1071 Humidichip and and the Dosimeter Dosimeter indicator indicator card. card. Place the Humidichip so that it will be near the metal shelf.

Choose an EOGas cartridge from the dispenser box. Confirm that the number printed on the EOGas cartridge corresponds with the number printed on the sterilization bag you have chosen. Remove the safety tab on the EOGas cartridge (covered with tape) and place the EOGas cartridge into the sterilization bag, but do not activate it at this time.

Remove excess air with a vacuum sealer or press the excess air out of the sterilization bag and heat seal it.

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When the cabinet has been purged, "Door unlocked" will be displayed and the door will unlock. Place the sterilization steriliz ation bag on a shelf in the sterilizer. steril izer.

Without opening the sterilization bag, grasp the cartridge of EOGas through the wall of the sterilization bag and press the plunger to activate the cartridge.

Close the door securely. It will lock automatically. automaticall y. Leave the sterilization bag undisturbed in the sterilizer cabinet for 16 hours. After the sterilization cycle is complete, the sterile contents of the sterilization bag may be removed and used. After the sterile material has been removed from the sterilization steriliz ation bag, the empty gas cartridge and the sterilization bag may be disposed of in an ordinary rubbish container. The garbage container should be in a well-ventilated area.

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Activating Activating the EOGas EOGas Cartridge Cartridge

1

Remove cartridge trigger guard.

No 5

2

Be sure cartridge number matches sterilizer bag number. Place cartridge cartridge into into loaded bag (see Processing Review: Description of an EOGas Cycle.)

5 N o 5

3

4

Remove excess air from bag and heat seal.

Place bag into sterilizer cabinet. Firmly grasp cartridge through bag and depress trigger completely to release gas.

No 5

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CAUTION It is incumbent on the user to confirm that gas absorbent items sterilized in EOGas have been adequately aired before they contact living living tissue. This is particularly particularly important for plastic or rubber items that will contact tissue culture preparations, microbial cell cultures, cultures, spermatocytes, oocytes, oocytes, embryonic tissue, etc. Failure to adequately air Ethylene oxide-absorbent materials may lead to contact chemical burns. The 16 hour sterilization cycle time at 50ºC called for in these instructions includes an adequate amount of time to air most tubes, masks and the like. Large gas absorbent items like breast implants and plastic extracorporeal blood filters may require additional aeration before they can be safely implanted or used. Aeration will progress more rapidly outside of the sterilization bag. Customers may obtain assistance in determining aeration times by contacting the Manufacturer or Distributor as listed on page 2 of this manual. Steritest® Biological Indicators Each AN1080 Steritest Biological Steritest Biological and Chemical Sterilizer Control pouch is a complete sterility control. Steritest eliminates the possibility of a false positive by including both a spore strip and an ampoule of sterile culture broth sealed in a transparent, gas permeable, waterproof, plastic pouch. Place the unopened Steritest with the items to be sterilized. At the end of of the cycle, remove the Steritest and look at the Dosimeter. Dosimeter. A color change from yellow yellow to blue that extends to the triangular mark on the Dosimeter label indicates that a dose of Ethylene oxide sufficient for sterilization has been delivered. Without opening the Steritest pouch, manipulate the ampoule of culture broth inside of its break shield so that the neck of the ampoule is broken. Gently shake the broth down to cover the spore disk. Incubate the Steritest at 37.5ºC for 72 hours. A change in the color of the broth from blue to orange indicates growth of bacteria and therefore an unsterile load. An incubator incubator for Steritest Steritest is available available from Andersen Andersen Products, Products, catalog number AN810. AN810.

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EOGas Sterilizer Operation

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SETTING STERILIZATION PARAMETERS AND OPERATING MODES SETUP MODE IN BRIEF Pressing the SETUP button initiates the screens for setting machine parameters. Pressing SETUP a second time exits and saves any changes. The SUPERVISOR CODE is needed to enter Setup: Press 14789 on the Control Panel Keypad and then ENTER. Calibrating the cabinet temperatur temperature e requires the TECHNICIAN CODE: Press 5344 on the Control Panel Keypad and then ENTER. Pressing the ENTER button moves through the items in order. Items flash on and off when selected. Use the UP/DOWN arrows to cycle through the choices for items. Numbers (time and date) are entered with the keypad. SETUP MODE IN DETAIL Setup Screens

SUPERVISOR CODE

Control Panel

SETUP Key

The Setup section may be entered from "Standby" if Standard Mode or Batch Mode are selected or at any time from Industrial Mode. This restriction assures that the sterilizer will not lose track of any bags that are already in process in Standard or Batch Mode. Once SETUP is pressed the Supervisor Code (14789) or the Technician Code (5344) must be entered on the Control Panel Keypad, followed by the ENTER button. The codes assure that only authorized personnel will change operating parameters or calibrate the temperature in the cabinet.

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Changing Parameters under the Supervisor Code

SUPERVISOR CODE

The two Setup screens have a total of ten parameters that may be changed, seven on the first screen and three on the second. Parameters that may be changed flash on and off. off. To move between the parameters and between the Setup screens press the ENTER key. language

Sterilizer number

#1 16

mode

ENG STNDRD 50º 11/08/05 13:26

The parameters and instructions for changing them are as follows: Sterilizer Number An integer integer 1 to 9. This allows multiple machines machines to be be used simultaneously. simultaneously. Each sterilizer is assigned a unique number. Language Cycle through choices using the UP/DOWN arrows. Default is ENG (English). Mode Standard (STNDRD), Batch (BATCH) or Industrial (INDUST) - use UP/DOWN arrows to toggle selections. Standard Mode is Mode is the only mode that prints labels and tracks the bags within the sterilizer. Each bag is given a unique label with a number. The number has one digit for the sterilizer number, two digits for the bag number (assigned by the computer) and six digits for the date in the format day/ month/year. For example, bag number number 2 08 220698 would indicate Sterilizer number 2, bag number 8 loaded on June 22, 1998. Batch Mode is Mode is used if all bags in a particular sterilizer are loaded and unloaded at the same time. Sterilization Sterilizat ion is done in "lots" that fill the sterilizer. steriliz er. No bags may be added to the sterilizer or removed from the sterilizer during the cycle. Industrial Mode is Mode is for commercial use. The operator must keep track of bag loading and unloading as as well as cycle length. This Mode may be used if appropriate, validated cycle parameters have been determined for the

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EOGas™ Series Plus Owner’s Manual temperature

#1 16

ENG STNDRD 50º 11/08/05 13:26

cycle length

time date

Temperature In degrees Celsius. Temperature of the cabinet may be changed from a minimum of 40ºC to a maximum of 55ºC in increments of 1º Celsius. The default temperature is 50ºC. Changing the temperature in the cabinet dramatically affects the sterilization sterilizat ion cycle. The temperature must not be changed except as part of a validated sterilization protocol. Cycle Length In hours (H). The default cycle length is 16 hours (16H). Cycle length may be changed from a minimum of 16 hours to a maximum of 24 hours in increment of 1 hour using the UP/DOWN arrows. Cycle length must not be changed except as part of a validated sterilization protocol. protocol. Date In format day/month/year. day/month/year. Enter the date using the keypad. Time 24-hour clock. Enter the time using the keypad.

operator code

print interval

PRINT 15M CODE CHANGE CODE ?

YES NO

Print Interval CE, 1M, 15M, 30M, 1HR, 2HR, 4HR, 6HR. Move through the choices using the UP/DOWN arrows. CE stands for “Cycle End”. In this case, cycle information is printed by the panelmounted printer only at the end of the cycle (i.e., whenever the UNLOAD button is pressed). 1M is one minute intervals, 15M is 15 minute intervals, 30M is 30 minute intervals, 1HR is 1 hour intervals, 2HR is 2 hour intervals, 4HR is 4 hour intervals, and 6 HR is 6 hour intervals. Code Yes or No. Toggle the choice with the UP/DOWN arrows. The Operator Code is a 3 digit code that must be set by the customer (unlike the Supervisor Code and Technician Code). It is designed to avoid unauthorized entry into the sterilizer. Only one code may be assigned for each machine, but it may be changed at any time. If CODE is set YES YES then the operator is given the option of changing the code. 23


Change Code YES or NO. Toggle the choice with the UP/DOWN UP/DOWN arrows. Default is set to NO. To change the OPERATOR CODE, toggle to YES and press ENTER. The following screen will appear:

SET NEW CODE *** REPEAT REPEAT NEW CODE ***

Enter a new 3 digit code using the keypad. Press ENTER then repeat the same 3 digit code and press ENTER again. If the same 3 digit code is used both times the code will be set to the new code. Calibrating Temperature under the Technician Code Temperature Calibration should be done by a qualified service technician at regular intervals, preferably at least twice a year. A calibrated thermocouple is needed. The thermocouple must be placed inside the cabinet according to the temperature calibration protocol for that unit.

Thermocouple

To calibrate temperature, the machine must be in INDUSTRIAL mode and the cabinet must be at a steady-state temperature (wait 30 minutes with the door closed to reach steadystate temperature). To begin calibration, press SETUP, then enter the technician code (5344) and then press ENTER.

SUPERVISOR CODE ****

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The first screen will show the lot number of the sterilizer and the version number of the software:

EOGAS 3+ LOT 160705 VER 1.30

The second screen will show the previous temperature calibration:

PREVIOUS CALIBRATION 46.5ºC TO 50.6ºC

Press ENTER, then input the temperature from the thermocouple. temperature in cabinet as read by sensor

SENSOR TEMP 49.8ºC SET TEMP TO 00.0ºC

input actual temperature from calibrated thermocouple

After the actual temperature temperature is entered entered using using the keypad, keypad, press ENTER. ENTER. The change change will be displayed on the screen:

PREVIOUS CALIBRATION 49.8ºC TO 51.1ºC

Press SETUP to return to INDUSTRIAL mode screen or press ENTER to set the temperature again. 25


OPERATING THE STERILIZER The steps required for operation of the sterilizer depend on the mode chosen. The 3 modes are STANDARD, BATCH and INDUSTRIAL. The LOAD and UNLOAD functions are described below for each mode. PRECONDITIONING CYCLE The Preconditioning Cycle is a 4 hour cycle cycle which humidifies a load prior prior to sterilization. The machine will warm up and maintain a temperature of 50ºC for 2 hours, then cool down to room temperature for 2 hours. Humidification is an important part of the sterilization cycle (see page 12, " Humidifying"). Humidifying"). Items that may be immersed in water and towel or drip-dried will not need preconditioning. Items that may be damaged by immersion in water or a load that contains a large amount of material that will absorb water (dry paper and cloth) may need humidification. humidificati on. The items Review") should be wrapped and prepared in the usual way (see page 12, " Processing Review") with an EOGas Cartridge, AN1071 Humidichip, AN85 Color Change Indicator and/or AN1087 Dosimeter. The bag should be be sealed sealed but the EOGas EOGas Cartridge Cartridge should should not be be activated. This cycle may be used only when the machine is in STANDBY mode (no bags in process). Press the zero key twice (00). The following screen will appear:

PRESS ENTER 25ºC FOR PRECONDITIONING

ZERO (0) key

Press ENTER and the display will read:

DOOR UNLOCKED OK TO OPEN DOOR

25ºC

ENTER key

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Then once the door is open bags to be preconditioned may be loaded:

DOOR OPEN LOAD BAG

25ºC 03:00

Close the door after loading the bags. If the door is not closed by the time the timer gets to 00:00, the following screen will be shown and the alarm will sound until the door is closed:

CLOSE DOOR LOAD BAG

25ºC 00:00

Once the door is closed and the timer has finished counting down the machine will enter the Preconditioning Cycle:

PRECONDITIONING WARMUP

25ºC 1:59:59

The temperature will warm up to 50ºC and after 2 hours the machine will cool down to room temperature. The display will read:

PRESS ENTER COOLDOWN

50ºC 1:59:59

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After the 2 hour cool cool down period, period, the display display will read: read:

PRECONDITIONING DONE

27ºC

If necessary, bags may be removed from the machine after the first 2 hours and allowed to cool outside the sterilizer for 2 hours. This has the advantage of of not tying up the sterilizer for another 2 hours. However, the person operating the sterilizer sterili zer will then have to keep track of the "cool down" time. If the bags are left in the sterilizer the machine keeps track of the time. To unload the bags, press the UNLOAD key:

DOOR UNLOCKED OK TO UNLOAD

50ºC 03:00

Once the door has been opened the display will read:

DOOR OPEN UNLOAD BAG

25ºC 2:59

Once the bags have been removed, close the door and the sterilizer will go back to STANDBY mode. At that point, a sterilization steriliz ation cycle may be started as described later in the manual.

28


STANDARD OPERATING MODE (STNDRD) In STANDARD Mode, the microprocessor keeps track of the bags in process in the sterilizer, and the operator may load new bags and unload finished bags while others are in process. When a bag is loaded, two labels are printed. One must be placed on the outside of the bag, the other should be placed in a sterilization log book. Each bag is given a unique label. The machine notifies the operator when bags are ready to be removed from the machine. If there are no bags in the sterilizer, the machine will enter STANDBY to save energy. The heaters are turned off in STANDBY but the fans continue to operate. Loading the Sterilizer in Standard Operating Mode Loading the machine starts with pressing the LOAD key on the front panel. In STANDBY the operator is prompted to press the LOAD key:

PRESS STANDBY STANDBY 50ºC PRESS LOAD TO START

LOAD key

If bags are already in process, LOAD may be pressed to add additional bags to the machine.

If an OPERATOR CODE is required (3 digit code), the machine will prompt the operator for the code, which should be entered using the keypad followed by ENTER:

OPERATOR OPERATOR CODE COD E ***

ENTER key

29


The sterilizer will then prompt the operator to enter the number of bags to load:

INPUT THE NUMBER OF BAGS TO LOAD 00

The number of bags may be set using the keypad or the UP and DOWN arrows

INPUT THE NUMBER OF BAGS TO LOAD 00

UP arrow keypad

DOWN arrow

ENTER

After the number number of of bags has has been set, set, press the the ENTER key key to confirm. confirm. The sterilizer will then enter a WARMUP cycle (if there were no bags already in process) or a PURGE cycle (if bags are in process) The WARMUP cycle is identified by the following screen: Internal temperature of cabinet

WARMUP DOOR UNLOCK AT

28.7ºC 48ºC

2ºC below set operating temperature

The door will unlock allowing bags to be loaded after the temperature reaches 2ºC below the operating temperature (in this example 48ºC which is 2º less then 50ºC).

30


The PURGE cycle is identified by the following screen: countdown timer

PURGING 06 BAGS

05:00 02 DONE

Purging is high volume ventilation to remove any residual Ethylene oxide from the cabinet. The door will unlock after the timer counts down to 00:00 At this point point the door door will unlock to allow bags bags to be loaded. loaded. A "beep" will sound every every 15 seconds to notify the operator that the cabinet is ready for loading. The screen will read:


48ºC

Bags may now be loaded. Once the door is opened opened to load the bags the screen will read: countdown timer

DOOR OPEN LOAD BAG 1 01

03:00 110205

Bag number - view the other bags using the arrow

The bag numbers for the bags to be loaded may be viewed on the screen, if desired. Cycle through the bags to be loaded using the UP and DOWN DOWN arrows. The door may be opened and closed as many times as desired while the counter is counting down to 00:00. After loading the bags, close the door to the sterilizer. It will lock automatically after the countdown timer reaches 00:00.

31


If the door is still open when the counter reaches 00:00, an alarm will sound to notify the operator and the screen will display:

CLOSE DOOR

49ºC

Once the door is closed, it locks automatically and the STANDARD Mode normal operating screen is displayed:

STERILIZING 08 BAGS

indicates total number of bags in process

49.8C 09:18

time (24 hour clock)

32


Unloading the Sterilizer in Standard Operating Mode The STANDARD Mode normal operating screen displays the total number of bags in process, and the number of bags that are done. Before the sterilization cycle is complete only the supervisor may unload bags (see "Emergency Unloading" on Unloading" on p. 43). The screen will show the following information during a cycle before any bags are done.

STERILIZING 06 BAGS

Indicates total number of bags in process

50.0ºC 15:52


Once one or more bags are done the display changes. The following example shows there are 6 bags in the machine, 2 of which are done.

STERILIZING 06 BAGS

50.0ºC 02 DONE

6 bags in process 2 bags done

To unload the bags that are done, start by pressing the UNLOAD key:

STERILIZING 06 BAGS

50.0ºC 02 DONE

UNLOAD key

33


If an OPERATOR CODE is required (3 digit code), the machine will prompt the operator for the code, which should be entered using the keypad, followed by ENTER:

OPERATOR OPERATOR CODE ***

The machine will begin purging (high volume ventilation to remove any residual Ethylene oxide from the cabinet) and the screen will display:

PURGING 06 BAGS

05:00 02 DONE

The counter will count down to 00:00 during the purge, then the machine will unlock the door to allow bag removal:


50.0ºC

A "beep" will sound every every 15 seconds to notify the operator operator that the door may be opened opened to remove bags. Once the door is opened the screen will read: countdown clock

DOOR OPEN UNLOAD BAG 1 01

03:00 110205

bag numbers of finished bags - view the other finished bags using the arrow keys 34


The bag numbers for the bags to be unloaded may be viewed on the screen, if desired. Cycle through the bags to be unloaded using the UP and and DOWN arrows. The door may be opened and closed as many times as desired while the counter is counting down to 00:00. After unloading unloading the bags, close close the door door to the sterilizer. It will lock automatically automatically after the countdown timer reaches 00:00. The sterilizer will assume that all bags that have completed the sterilization cycle have been removed and they will no longer be listed as bags in process. If the door is still open when the counter reaches 00:00, an alarm will sound to notify the operator and the screen will display:

CLOSE DOOR

50ºC

Once the door is closed, it locks automatically and the STANDARD Mode normal operating screen is displayed:

STERILIZING 04 BAGS

indicates total number of bags in process

50.1ºC 12:07


In this example there are 4 bags remaining in the sterilizer. If the bags removed were the last bags in the machine, the sterilizer will enter STANDBY and the heaters and fans will shut down. The screen will display:

STNDRD STANDBY STANDBY 43ºC PRESS LOAD TO START

35


Repeating the PURGE Cycle while Unloading When unloading multiple bags or loads which absorb a large amount of gas, some operators like to cut open the end of the sterilization bag while it is still in the machine, then shut the door and repeat the PURGE cycle. This minimizes the chance of exposure to the residual Ethylene oxide within the bag. To repeat the purge when unloading, open the door when it is unlocked and cut open the end of the sterilization bags that will be removed. The display will read:

DOOR OPEN UNLD BAG

49ºC

Close the door and press "1" on the keypad to perform 1 hour additional Aeration, press "2" to perform 2 hours of additional aeration or "0" to perform 5 min additional aeration. The display will read:

EXTENDED AERATION AERATION 01:00

“1” key

After the counter reaches reaches 00:00 00:00 the door will unlock unlock again and the bags bags may be removed. removed. The display will read:

DOOR OPEN UNLD BAG

49ºC

After the door has has been closed, closed, the machine will will return to STERILIZIN STERILIZING G or STANDBY STANDBY depending on whether or not there are bags remaining in the machine. 36


BATCH MODE (BATCH) BATCH Mode does not track the bags by specific numbers or labels. In BATCH Mode, all bags are loaded and unloaded simultaneously. No bags may be added during a cycle. If there are no bags in the sterilizer, the machine will enter STANDBY to save energy. The heaters and fans are turned off in STANDBY. Loading the Sterilizer in BATCH Mode Loading the machine starts with pressing the LOAD key on the front panel or on the separate keypad. The operator is prompted to press the LOAD key on the display:

BATCH STANDBY 28ºC PRESS LOAD TO START

LOAD key

If an OPERATOR CODE is required (3 digit code), the machine will prompt the operator for the code, which should be entered using the keypad, followed by the ENTER key.


ENTER key

The machine will enter a warmup cycle as the cabinet heats up to operating temperature.

internal cabinet temperature

WARMUP 34.1ºC DOOR UNLOCK AT 48ºC

two degrees below set operating temperature

37


The door will unlock allowing bags to be loaded after the temperature reaches 2ºC below the operating temperature. The screen will read:


48ºC

Once the door is opened to load bags the screen will read:

DOOR UNLOCKED DOOR OPEN

48ºC 03:00

door open countdown timer

The door may be opened and closed as many times as desired while the counter is counting down to 00:00. After loading the bags, close the door to the sterilizer. steriliz er. It will lock automatically after the countdown timer reaches 00:00. If the door is still open when the counter reaches 00:00, an alarm will sound to notify the operator and the screen will display:

CLOSE DOOR

49ºC

Once the door is closed, it locks automatically and the BATCH Mode normal operating screen is displayed:

Cabinet temperature

STERILIZING 15:48

24-hour clock

49.4ºC FINISH 07:48

time cycle will be complete

38


Unloading the Sterilizer in BATCH Mode When the sterilization cycle is complete the screen will display:

CYCLE DONE 50.0ºC 08:17 FINISH 07:48

24 - hour clock

UNLOAD key

time cycle complete

To unload the machine, press the UNLOAD key on the front panel. If an OPERATOR CODE is required (3 digit code), the machine will prompt the operator for the code, which should be entered using the keypad:


The machine will enter a PURGE cycle:

PURGING

05:00

countdown timer for purge

After purging, purging, the door door will unlock, unlock, allowing bags to be unloaded. unloaded. The screen will read:


50ºC

39


A "beep" will will sound every every 15 seconds seconds to notify notify the operator that that the cabinet cabinet is ready ready for bags to be unloaded. Once the door is opened opened to unload the bags the screen will read:


50ºC 03:00


The door may be opened and closed as many times as desired while the counter is counting down to 00:00. After unloading the bags, close the door to the sterilizer. It will lock automatically after the countdown timer reaches 00:00. If the door is still open when the counter reaches 00:00, an alarm will sound to notify the operator and the screen will display:

CLOSE DOOR

49ºC

Once the door is closed, it locks automatically and the BATCH Mode STANDBY screen is displayed:

BATCH STANDBY 48ºC PRESS LOAD TO START

40


Repeating the Purge Cycle while Unloading When unloading multiple bags or loads which absorb a large amount of gas, some operators like to cut open the end of the sterilization bag while it is still in the machine, then shut the door and repeat the purge cycle. This minimizes the chance of exposure to the residual ethylene oxide within the bag. To repeat the purge when unloading, open the door when it is unlocked. Cut open the end of the sterilization bag that will be removed, with the open end of the bag facing away from the operator. The display will read:

DOOR OPEN UNLD BAG

49ºC

Close the door and press "1" on the keypad to perform 1 hour additional Aeration, press "2" to perform 2 hours of additional aeration or "0" to perform 5 min additional aeration. The display will read:

EXTENDED AERATION AERATION

“1” key

After the counter reaches reaches 00:00 00:00 the door will unlock unlock again and the bags bags may be removed. removed. The display will read:

DOOR OPEN UNLD BAG

49ºC

After the door door has been closed, closed, the machine will will return to STANDBY. STANDBY.

41


INDUSTRIAL MODE (INDUSTRIAL) The Industrial Mode is designed for customers who do not want the sterilizer to track the bags or the cycle length. The customer must prepare Standard Operating Procedures (SOPs) and must validate cycle parameters to sterilize in Industrial Mode. Andersen has a sterilization cycle validation service to assist in creating the SOPs and cycle parameters if the customer desires. In INDUSTRIAL Mode there is no STANDBY STANDBY function. The heaters and ventilation are on at all times. The only functions used are LOAD and UNLOAD. The following is an example of the display for INDUSTRIAL Mode:

INDUSTRIAL 09:37

internal cabinet temperature

50.1ºC 29/06/05

24 - hour cycle Date in day/month/year format

To LOAD or UNLOAD, press the appropriate button. If an OPERATOR CODE is required (3 digit code), the machine will prompt the operator for the code, which should be entered using the keypad:

OPERATOR OPERATOR CODE ***

The machine will enter a PURGE cycle:

PURGING

05:00

countdown timer for purge

42


After purging, purging, the door door will unlock unlock allowing bags bags to be be loaded or or unloaded. unloaded. The screen will read:


50ºC

A "beep" will will sound every every 15 seconds seconds to notify notify the operator that that the cabinet cabinet is ready ready for bags to be loaded or unloaded. Once the door is opened to load or unload bags the screen will read:


50ºC 03:00


The door may be opened and closed as many times as desired while the counter is counting down to 00:00. After loading or unloading bags, close the door to the sterilizer. steriliz er. It will lock automatically after the countdown timer reaches 00:00. If the door is still open when the counter reaches 00:00, an alarm will sound to notify the operator and the screen will display:

CLOSE DOOR

49ºC

Once the door is closed, it locks automatically and the INDUSTRIAL Mode operating screen is displayed:

INDUSTRIAL 09:37

50.1ºC 29/06/05

43


EMERGENCY UNLOADING TO UNLOAD BAGS BEFORE THE END OF A STERILIZATION CYCLE Supervisor Unload may be used in STANDARD Mode Mode or in BATCH Mode. Supervisor Unload is automatically selected if there are no bags done with the sterilization cycle and UNLOAD is pressed. This feature allows items to be removed from the sterilizer steril izer before the sterilization cycle is complete. Standard Mode Supervisor Unload In a STANDARD Mode Cycle, if no bags are done and UNLOAD is pressed the following screen will appear:

NO BAGS DONE SUPERVISOR CODE

50ºC *****

Enter the 5 digit Supervisor Code (14789) then press the ENTER key. key. The sterilizer will start purging:

PURGING 05:00 SUPERVISOR UNLOAD

After the counter reaches reaches 00:00, 00:00, the door will unlock unlock to allow bags to be be unloaded: unloaded:

DOOR UNLOCKED OK TO UNLOAD

50ºC

44


when the door is opened, opened, the Supervisor must select the bags to be removed. The number of the bag will flash on the screen. If the ENTER key is pressed the bag number will stop flashing, indicating that it has been selected for removal. Cycle through the bags using the UP and DOWN DOWN arrow keys to choose the ones that will be removed. Select each of the bags by pressing ENTER. If a bag is accidentally chosen, it may be deselected by pressing ENTER a second time. The bag number will start flashing again indicating it has been deselected. Example of Supervisor Unload In the following example, bags 3 and 5 must be unloaded before the end of the cycle:

SELECT BAGS UNLD BAG 2 01

05:00 210705

The "01" in the bag number will be flashing. Press the UP arrow twice to get to bag number 3:

SELECT BAGS 05:00 UNLD BAG 2 03 210705

Hit the ENTER key and the "03" will stop flashing. Press the UP arrow two more times to get to bag 5. Press ENTER to select bag 5.

SELECT BAGS UNLD BAG 2

05

05:00 210705

At this point point the bags bags may be removed from from the sterilizer. sterilizer. The bag numbers for for the selected bags will be removed from computer memory, and the cycle will continue normally.

45


Batch Mode Supervisor Unload In BATCH Mode if no bags are done and UNLOAD is pressed the following screen will appear:

NO BAGS DONE SUPERVISOR CODE

50ºC *****

Enter the 5 digit Supervisor Code (14789) then press the ENTER key. key. The sterilizer will start purging:

PURGING 05:00 SUPERVISOR UNLOAD

After the counter reaches reaches 00:00, 00:00, the door will unlock unlock to allow bags to be be unloaded: unloaded:


50ºC

When the door is opened the screen will read:


50ºC 05:00

The bags may be removed from the sterilizer. The sterilizer will assume that all bags have been removed from the sterilizer and will return to STANDBY after the door open counter reaches 00:00. 46


Power Outage During a power outage the door can be opened mechanically. mechanicall y. Remove the top cover panel

and lift up on the door lock mechanism.

Door lock mechanism

Once the door is opened the lock will remain lowered and will have to be raised by hand to close again. (See also p. 68 - "Manual Door Unlock"). Unlock").

47


LABEL PRINTER The label printer is only used for STANDARD Mode operation of the EOGas Series 3 Plus sterilizer. sterili zer. The printer is attached to the left side of the sterilizer steriliz er (when facing the front door of the machine). There are two connections between the sterilizer and label printer, one for power (3 pin locking ring connector), and the other for data transfer (25 pin connector). Both of these must be securely connected for proper operation of the label printer.

Once the power is switched on, the light will notify the operator about the status of the printer:

Green Light - Power on, ready Red Light - Power on, out of labels

The label printer will print two copies of each bag identification label after the LOAD key is pressed and the operator keys in the number of bags that will be loaded. For example, if four bags will be loaded, four pairs of of labels will be printed. One of each pair of labels must be placed on the outside of the sterilization bag and the other should be placed in a sterilization logbook.

The following is an example of a label: BAG NUMBER: 1 03 150498 START: 12:10 15/04/98 CYCLE LENGTH: 16 HOURS

1 = sterilizer number, 03 = bag number, 150498 = date in day/month/year format 12:10 is the time the bag was loaded, 15/04/98 is the date 48


Replacing the Roll of Label Paper

Release the levers on each side of cover. Lift cover. Remove current paper roll.

49


Place a new roll into printer roller. Through the paper guard's all the way to the front of the printer. Light should be red.

Close the cover back. Light will turn green. Press the feed button to feed the label through.

50


PANEL-MOUNTED PRINTER The Panel-Mounted Printer is located on the top front right of the Sterilizer Cabinet, next to the Control Panel. Printing is automatic every time the UNLOAD key is pressed at the end of a cycle. Pushing PRINT STATUS prints the same information at any any time during the cycle. Regular printouts during the cycle may be obtained by adjusting the printing interval (PRINT) in the SETUP menu.

STANDARD Cycle Sample Printout: UNIT #2 10:43 12/02/05 CYCLE LENGTH: 16 hours DOOR OPEN: 09:24-09:28

sterilizer steriliz er number, current time, current date (day/month/year format) length of sterilization steril ization cycle will show up to 4 door openings per cycle. The initial door opening to load the sterilizer is not included

PROBLEMS: NONE possible problems that will be printed if they occur are: HIGH TEMP ##:## - ##:## start and end times for high temp (up to 2 per cycle) LOW TEMP ##:## - ##:## start and end times for low temp (up to 2 per cycle) POWER FAIL ##:## - ##:## start and end times for power failure (up to 3 per cycle) VENT FAIL ##:## - ##:## start and end times for ventilation failure (up to 2 per cycle) BAGS IN PROCESS: 08

BAG NO. 2 05110205 2 06110205 2 07110205 2 08110205

START 20:11 20:11 20:11 20:11

BAGS DONE: 04 2 01 110205 2 02 110205 2 03 110205 2 04 110205

shows 8 bags in process then lists the bag number, start time, and time remaining in the cycle for each bag.

REMAIN 01:28 01:28 01:28 01:28

tells number of bags done then lists the bag numbers

51


BATCH Cycle Sample Printout: UNIT#2 10:43 12/02/05

sterilizer sterili zer number, current time, current date (day/month/ year format) cycle start time, start date length of sterilization steriliz ation cycle

START: 14:11 11/02/05 CYCLE LENGTH: 16 hours PROBLEMS: NONE possible problems that will be printed if they occur are: HIGH TEMP ##:## - ##:## start and end times for high temp (up to 2 per cycle) LOW TEMP ##:## - ##:## start and end times for low temp (up to 2 per cycle) POWER FAIL ##:## - ##:## start and end times for power failure (up to 3 per cycle) VENT FAIL ##:## - ##:## start and end times for ventilation ventilati on failure (up to 2 per cycle)

INDUSTRIAL INDUSTRIAL Cycle C ycle Sample Printout: UNIT#2 12:31 18/07/05

sterilizer sterili zer number, current time, current date (day/month/ year format) time and date the door was most recently opened

START 14:11 18/07/05 PROBLEMS: NONE possible problems that will be printed if they occur are: HIGH TEMP ##:## - ##:## start and end times for high temp (up to 2 per cycle) LOW TEMP ##:## - ##:## start and end times for low temp (up to 2 per cycle) POWER FAIL ##:## - ##:## start and end times for power failure (up to 3 per cycle) VENT FAIL ##:## - ##:## start and end times for ventilation ventilati on failure (up to 2 per cycle)

52


Changing the Paper Roll When the paper is nearing the end of the roll, a red dye will be seen on the edge. The paper should be changed:

Remove the printer cover with a downward motion

Press the PRINT FEED key on the front panel keypad to expel remaining paper from the printer. Follow instructions on the printer for removal of the roll, left-hand side first.

Feed the paper on the replacement roll through the printer head and the ribbon cassette and then locate the roll in position. Press the PRINT FEED button on the front panel keypad until 1 inch (2 cm) of paper is exposed and pass that through the slot in the outer cover.

53


Ribbon Cartridge Replacement To replace the ribbon cartridge proceed as follows:

Remove the black printer cover.

Press the end of the cartridge marked PUSH/EJECT. The cartridge will swing out to the left; remove it from the printer.

Rotate the new cartridge dial as shown by the arrow to tighten up the ribbon. With the ribbon facing up, feed the paper between the cartridge and the ribbon. Replace the cartridge into the printer. Press the FEED button on the front panel keypad until 1 inch (2 cm) of paper is exposed and feed that through the outer cover. Replace the outer cover. To confirm that the new ribbon is working properly, press the PRINT STATUS button on the front panel keypad.

54


Maintenance and Troubleshooting

55


ALARMS Ventilation Alarms A vacuum transducer mounted in the component component module module controls controls the ventilation ventilation alarm. alarm. A tube is connected to the main sterilizing sterilizi ng cabinet to sense cabinet vacuum. Another tube is open to room air. Extraction of exhaust gas ensures a negative pressure in the main cabinet of 0.13 to 0.15 inches of H20 with respect to room pressure. The vacuum transducer is calibrated by the manufacturer and should not require readjustment. Ventilation Failure: Rapid beeping beeping The ventilation monitor is active during the entire cycle except during purge and when the door is open. If the ventilation unit fails or the outlet is blocked, the words "VENT FAIL" will be seen on the screen and the unit will beep rapidly. The time the ventilation failed and the time it came back on will be printed in the "PROBLEMS" section of the printout at the end of the cycle. The machine will keep track of the first 2 ventilation failures in each cycle. Troubleshooting Ventilation Alarms (see Figure 12 in Appendices) 1) Verify that the sterilizer power is on and the display appears normal. Verify that the blower is on and working. 2) Remove the top cover and locate the vacuum transducer board. Connect the negative lead of a DC voltmeter to the "GND" test point. 3) Check the voltage at U1, Pin 8. It must be 5.0 volts for the board to function. This 5 volts is supplied from an external power supply. 4) Check the voltage at the "2.490v Reference" test point. It should be very close to 2.490v and may be adjusted with R5. 5) Open the door to the sterilizer steriliz er and unplug the blower. Check the voltage at the ".500v Offset" test\ point. It should be close to .500v and may be adjusted with R2. (It is normal for this voltage to drift slightly). 6) Close the door and plug in the blower. Check the voltage at the ".500v Offset" test point. It should be .60 volts or higher. A voltage lower than .6 volts signifies that the air pressure within the sterilizer is not low enough with respect to the air pressure in the room. Check the plastic tubes connected to the board. The P2 tube should lead to the inside of the sterilizer sterili zer chamber. The P1 tube should lead to a fitting on the back of the sterilizer. sterili zer. Verify that the fitting is not blocked. 7) If none of the above leads to a solution: Write down the measurements taken in steps 1-6. Check the voltage at the "Trigger Level" test point and write it down. Customers should contact the Manufacturer or Distributor as listed on page 2 of this manual.

56


High or Low Low Temperature: Single beep every 10 seconds If the temperature is more than 2ºC above or below the set temperature the words "HIGH TEMP" or "LOW TEMP" will be seen on the screen and the printer will start printing the cabinet temperature every minute. The time the temperature became too low or too high and the time it returned to normal will be printed in the "PROBLEMS" section of the printout at the end of of the cycle. The machine will keep track of the first 2 high or low temperatures in each cycle. The temperature monitor is deactivated by opening the door for loading or unloading. It becomes active 10 minutes after after the door is closed. This allows the temperature in the cabinet to reach steadystate prior to temperature monitor activation. High and Low temperatures during the cycle indicate a significant problem with the machine. Therefore, if there is a high temperature or low temperature recorded, even if only for a short interval, the machine should be serviced. Also, it may be necessary to resterilize resteri lize items that were inside the sterilizer, particularly in the case of a low temperature of significant duration. Door Unlocked Unlocked or Waiting for Input: Input: Single beep every every 15 seconds A single beep beep will be emitted every every 15 seconds wheneve wheneverr the door is unlocked. This alarm is designed to remind the operator that the machine is waiting for something to be done. If the machine is expecting input and it does not occur, it will revert to the previous state after 10 minutes. For example, if the machine is STERILIZING and UNLOAD is pressed, the machine purges and unlocks, then beeps every 15 seconds while waiting for the door to be opened. If the door does not open within 10 minutes the machine will go back to the previous state (STERILIZING). End of Cycle in STNDRD or BATCH Mode: 5 beeps at the e nd of the cycle In STANDARD and BATCH Modes, 5 beeps will be emitted at the end of the cycle to alert the operator that one or more bags are ready to be unloaded. Door Open Too Long or Temperature Temperature > 80ºCelsius: 80ºCelsius: Constant alarm In the unlikely event of a catastrophic failure with temperature control which allows the temperature to get above above 80ºC, the alarm will will sound constantly. This is an emergent problem and the machine should be unplugged and not used until repaired. The alarm also sounds continuously if the door is left open too long for loading or unloading (3 minutes is allowed). The display will read "CLOSE DOOR". If the door is inadvertently opened during a cycle, the alarm will sound continuously. Power Failure The machine will keep track of the first 3 power failures during each cycle and will print the time the power went off and the time it came back on. on. This information is also printed as soon as the power comes back on, so if there are more than 3 power failures they may be identified on the printout even if they are not listed under "PROBLEMS".

57


EOGAS STERILIZING CHAMBER A variation within 2ºC from the normal normal operating operating temperature temperature of of 50ºC is considered considered acceptable as long as the cabinet has been operating at 50ºC for one hour. To calibrate the temperature on the display, see "Calibrating Temperature under the Technician Code" (p. 23) in the "Setting Sterilization Parameters and Operating Modes" section (p. 20). Twice per year confirm the sensitivity of the ventilation alarm and the integrity of the circuit. Test by disconnecting the power supply to the exhaust extractor from the cabinet receptacle. (Units with an abator, switch off the exhaust blower). The alarm should operate within 15 seconds. Reconnect the power supply and the alarm should cease. All painted and stainless stainless steel steel finishes may may be washed washed with any any available available detergent. detergent. The polycarbonate finish of the membrane switch and front panel assembly may be cleaned with any cleaning agent and is resistant to abrasion and chlorine based cleaners. HEPA FILTER REPLACEMENT At six month intervals, or or sooner in lint laden environments, environments, replace the air inlet inlet filter on the top panel. The filter cartridge is of the HEPA type (Part No 4294) and can be replaced by lifting off the cover,

removing the existing filter, inserting a fresh cartridge

and replacing the cover. If there is substantial debris in the filter holder, it may be necessary to clean it with a vacuum cleaner.

58


ABATOR AND EXHAUST ASSEMBLY Maintenance Maintenance of the Abator is restricted to inspecting the inlet and exhaust ducting, and the replacement of the catalytic absorber. To replace the absorber material, remove the top cover panel of the Abator catalyst, remove and replace the absorber material and refit the cover plate. The time interval between replacements of the catalyst depends on the amount of Ethylene oxide used. A period period of two years is usually considered appropriate. Sampling the exhaust air as it leaves the Exhaust Blower should show zero emissions. emissions. Any level detected above zero indicates a need for catalyst replacement. Exhaust Blower The Exhaust Blower bearings require oiling with a light machine oil at 6-month intervals, accompanied by an inspection to confirm the mountings, bearings, etc., are in good working order.

59


ANDERSEN AN5026 VACUUM SEALER The Andersen AN5026 Vacuum Sealer is self-contained, easy to maintain, and allows multiple configurations for a wide range of applications. The sealer is available with a 26" seal length and is available in both 110V and 220V models. 9 preset jaw pressure, heating and cooling settings are easily changed by the user and safety switches protect the operator's fingers during sealing.

FEATURES No pneumatic cylinders Self-contained No shop air or vacuum source needed Easy to maintain Automatic detection detection of broken switches Easy to use Digital display and digital control May be connected to gas flush or external vacuum source if desired

AN5026 Power Usage: 110 V@60Hz or 220V@50Hz 220V@50Hz Shipping Wt: 392lbs/178kg 392lbs/178kg Dimensions: 32"x29"x45" 32"x29"x45" / 81.28x73.66x114.3cm 81.28x73.66x114.3cm

Please See AN5026 Owner's Manual For More Details 60


CIRCUIT BREAKERS

The circuit breakers are DIN rail mount type units and are located as shown on Figure 7 of the Appendix. The circuit breakers are reset with the traditional toggle switch. Access to reset the circuit breakers is by removing the top panel cover (see Maintenance and Troubleshooting: Troubleshooting: Component Module Replacement Replacement on on p. 69).

61


DOOR ADJUSTMENT Door Gasket Replacement

The gasket is mounted to the door with the stainless steel inner door liner. With the door in place on the sterilizer, unscrew the inner door liner, starting with the top edge. Progressively unscrew the vertical screws approximately half way down on each side.

Remove the existing gasket. Mount the new gasket on the top horizontal edge and down the sides. Attach the door liner back into position across the top edge and part way down the door sides. Remove the remaining gasket and continue attaching the new gasket along with the inner door liner.

62


BATTERY REPLACEMENT There is a 3.0 Volt battery that acts as backup power for the computer. When the battery is low (less than 2.0 Volts), a message will appear on the screen reading:

LOW BATTERY REPLACE BATTERY BATTERY

This will be seen for 5 seconds every time "LOAD" is pressed. The machine will still function normally, and there will be a period of time, probably several months, before the battery will actually fail. When the message is seen, the operator may continue using the machine, but as soon as it is convenient the battery should be replaced.

To replace the battery, gently lift the retaining clip on the battery as shown and slide the battery out of the holder on the circuit board. Reverse the process to insert the new battery.

63


FUSE REPLACEMENT The fuse compartment contains two fuses. On 110/120V models there is one line fuse and one spare fuse. For 220/240V units both fuses are used as as line fuses. To change the fuse, switch off power. Remove the incoming power cord and pry out the fuseholder cover (see photos on next page). A list of Fuses Fuses and Circuit Circuit Breakers Breakers is attached attached to the back back of the the sterilizer

Device

Label Printer Exhaust Extractor Circulating Circulati ng Fan Label Printer

Incoming Power Incoming Power

Fuse types and ratings are: F1/F2 (240V) F3

Schematic Reference CIRCUIT BREAKERS K9 K10 K11 K12

220.240v Units

2A 0.75A 0.50A 0.30A

FUSES F1 F1/F2

8.0A

8.0A 4.0A

GDA - IEC 127-2 Sheet 1 Type 3AG Slow Blo Series 313

64


The fuse compartment contains two fuses - both used as line fuses. To replace, turn off the unit and remove the incoming power cord.

Use screwdriver to pry open fuseholder here

Fuse unit after removal. Replace fuses and ensure fuseholder is returned to the fuse compartment with the arrow marks aligned.

Fuse compartment

65


MANUAL DOOR UNLOCK

Remove the top cover

Control Panel Keyboard

Lift the door lock solenoid located in the front left corner of the component module

66


COMPONENT MODULE REPLACEMENT

Confirm the voltage, of the replacement component module. Disconnect the incoming power cable.

Disconnect the label printer power and data cables from the side of the cabinet.

Unscrew the blue exhaust hose flange

67


Remove both top covers.

Remove the vacuum sensing plastic hose line from the lower cabinet. Remove both top covers.

1 2

Unscrew the four screw in each corner. (Note: two of the screws hold the electronic assembly).

4

3

68


Carefully lift the front edge of the component module sufficient to enable the door hinge pin to be clear and remove the door. Remove the component module assembly.

Reinstall in reverse order, test the new component module and pack the replaced module for shipping.

69


Ethylene Oxide Safety

70


ETHYLENE OXIDE SAFETY OSHA Regulations Ethylene oxide has been used as a sterilizing steriliz ing gas for more than sixty years. Throughout that time there has been a continuous effort by all involved in its use to limit and reduce the exposure of workers to Ethylene oxide. Almost every country has health and safety regulations limiting limit ing exposure to Ethylene oxide. For many years, years, the U. S. was the most prominent user of Ethylene oxide and as a result has clearly defined regulations placed into legislation by the U. S. Occupational Safety and Health Administration (OSHA). The major concern for exposure occurs after Ethylene oxide has converted from a liquid to a gaseous state. As a gas, it is considered a respiratory hazard and is also classified as poisonous. As with all potentially noxious substances, e.g., chlorine, ammonia, and alcohol exposure should be kept to the absolute minimum. However, these chemicals are useful, so methods of measuring exposure and acceptable exposure levels contribute to safe use. Internationally Internationall y there are two defined defined circumstances that are measured: The Short Term Exposure Limit (STEL) for a fifteen minute period, and the Permissible Exposure Limit (PEL) over a longer eight hour exposure period. For either period, the amount of exposure is accumulated and averaged for the time of exposure. This is defined as the Time-Weighted Average (TWA) and measured in units of 1 part Ethylene oxide per 1,000,000 parts of air (ppm). In the U.S., OSHA has established that for the short time STEL the exposure level should not exceed 5.0 ppm, and for an 8 hour exposure PEL the level should be below 0.5 ppm. If the exposure levels exceed these, the users have more stringent protection requirements to meet. Workplace Testing Using specifically designed personnel monitor units is universally accepted as a reliable method of measuring worker exposure to Ethylene oxide. These are designed to be worn by an individual worker attached like a "badge" close to the person's breathing zone. These economical devices make it easy to assess any worker's level of exposure to ethylene oxide. Andersen Products offers a simple to use "badge" under the "AirScan" label for measuring both the short period STEL and longer monitoring period PEL. Information regarding their use is included in the Diagrams and Drawings section. The information given above is a summary. Refer to the relevant health and safety authority in the country of use. Precautions The EOGas cartridge contains liquid and gas under pressure. Do not use near fire, heated surface or flame. Do not not smoke near the sterilizer steriliz er while loading and unloading it. Sterilize batteries wrapped individually and separately from their electrical instruments.

71


Avoid breathing breathing EOGas EOGas vapor. vapor. Breathing EOGas vapor vapor is harmful. If you can can smell EOGas, you are breathing toxic amounts. In concentrated amounts amounts EOGas sterilizing gas is as irritating to the lungs and mucous membranes as is ammonia gas. As with other chemical vapors, there is a chance of an occasional allergic response to EOGas in a sensitive individual. Such individuals should not handle EOGas, and should neither breathe its vapors nor allow materials sterilized in it to come into contact with their skin or mucous membranes. All users must must avoid contact contact with the skin, eyes, eyes, and clothing. If contact with with liquid EOGas EOGas occurs, users must immediately immediatel y remove all contaminated clothing, including shoes. Flush skin or eyes with plenty of water for at least 15 minutes. If liquid EOGas has gotten into your eyes, immediately see a physician for further treatment. Chronic exposure to concentrations of Ethylene oxide (the active ingredient in EOGas) above 1 ppm may be dangerous to your health. All operators of Ethylene oxide gas sterilizers must be tested for Ethylene oxide exposure at frequent intervals. Failure to adequately air Ethylene oxide absorbing materials may lead to contact chemical burns. The 16 hour sterilization sterilizati on cycle time at 50¡C called for in these instructions instructi ons includes an adequate amount of time to air most tubes, masks and the like. Large gas absorbent items like silicone breast implants and plastic extracorporeal blood filters may require additional aeration before they can be safely implanted or used. Aeration will progress more rapidly outside of the sterilization bag. Andersen Products is prepared to determine determine aeration times for our customers. Call customer service at 336-376-3000 for more information. It is incumbent on the user to confirm that a gas absorbent item, sterilized in EOGas has been adequately aired before it contacts living tissue. This is a particularly particularl y important warning to those using plastic or rubber items that directly contact tissue culture preparations, microbial cell cultures, spermatocytes, oocytes, embryonic tissue, or the like. Vacuum dehydration, chemical desiccation or prolonged exposure to ambient native humidity below 30% have been demonstrated to produce spores highly resistant to sterilization by EOGas. Rehydration of spores so changed, and hence reversion to normal sensitivity, does not seem to occur until they have been actually wetted or placed in a 100% relative humidity humidit y atmosphere. Do not attempt to sterilize steriliz e materials which may be carrying dried spores without first washing the articles with water and detergents. If the nature of the material is such that the water treatments specified above are harmful, then pretreatment in a chamber having a saturated humidity at 50¡C is necessary - see "Processing Review" on p. 12. EOGas is a potent polymerizing agent. It must not be used for sterilizing foodstuffs or drugs. The user MUST NOT deviate from the Operating Instructions. EOGas cartridges are designed to be used only only in the EOGas sterilization sterilizat ion bag provided in the refill kit. An EOGas sterilizer sterili zer bag may not be reused. The use of of non-genuine EOGas cartridges and sterilizing sterilizi ng bags may compromise sterilizing performance and safety and in that event the manufacturer manufacturer will be freed from all liability. 72


APPENDIX 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 13.0 14.0 15.0 16.0

EOGas Sterilizer Operation Reference Chart Sterilizer Dimensions Heat Sealer Venting Through Outside Wall Venting to the Outside Wall Within Withi n an Interior Wall Exhaust Calculations Component Module Layout EOGas Extractor Unit Gas Disposal System Equipment Ratings Summary Controls Layout Ventilation Alarm Schematic Electrical Electric al Schematic Replacement Parts List IEC Warning Warni ng Symbols Material Safety Data Sheets

73

EOGas Sterilizer Operation Reference Chart


For complete instructions, see instruction brochure packaged with the cartridge

WARM - UP Make sure sterilizer is connected to power. Sterilizer should come up to temperature in about 15 min (50ºC).

STERILIZER WARMUP

PREPARATION OF ITEMS PREPARATION FOR STERILIZATIO STERILIZATION N 1. 2. 3. 4.

Disassemble and wash with detergent and water. Air-dry; do not oven-dry. Prehumidify items that cannot be washed. Wrap in paper, cloth, or EO permeable film.

PREPARATION

PREHUMIDIFICATION 1. Wrap items to be prehumidified individually as for sterilization. 2. Place wrapped items in medium (#5), or large (#6) sterilization bag. 3. Mark Dosimeter card with time/ date of sterilization and place in the core of the load. Include biological control if appropriate. 4. Match EOGas cartridge (#5, #6) with number on sterilization bag. Remove trigger safety and place EOGas cartridge in sterilization bag. 5. Heat-seal sterilization bag. DO NOT ACTIVATE EOGas CARTRIDGE. 6. Place sterilization bag in sterilizer cabinet. 7. Humidify sterilization bag contents for 2 hours at 50ºC. 8. Remove sterilization bag from sterilizer and humidify for an additional 2 PRE hours at room temperature HUMIDIFICATION before sterilization.

LOAD STERILIZATION BAG 1. 2.

3. 4.

5.

Place wrapped items in medium (#5), or large (#6) sterilization bag. Mark Dosimeter card with time/date of sterilization and place in the sterilization bag. Include biological biological control if appropriate. Place fresh Humidichip in sterilization bag. Match EOGas cartridge size (#5, #6) with number on sterilization sterilization bag. Remove trigger safety and place EOGas cartridge in sterilization bag. Heat-seal sterilization bag.

LOAD LINER BAG

BIOLOGICAL CONTROLS

BIOLOGICAL CONTROLS Challenge the EOGas procedure on the schedule recommended by your governing body or whenever changing packaging materials or techniques. Use a Steritest or other appropriate biological control. Position control in core of load.

START STERILIZATION CYCLE 1. 2. 3. 4.

Press Load button on sterilizer control panel. When purge cycle is complete, the door is unlocked and the cabinet can be opened. Activate EOGas cartridge within sterilization bag by depressing trigger button. Immediately place sterilization bag into sterilizer cabinet and close door.

START STERILIZATION

STERILIZATION AND AERATION 1. 2. 3.

4.

Leave sterilization bag undisturbed in the sterilizer for 16 hours. Sterilization and aeration proceed simultaneously during the 16-hour cycle. After 16 hours, remove the sterilization bag from the cabinet. cabinet. Check the Dosimeter; make sure the blue line has progressed beyond the triangular mark. Removed the sterile items from the sterilization bag. Discard the sterilization sterilization bag and used cartridge.

AERATION

STERILIZATION & AERATION

AERATION The 16-hour EOGas cycle at 50ºC includes an aeration period adequate for most EO absorbing materials. Large gas absorbent items, especially implants, or devices that will contact blood or living tissue, require additional, post sterilization aeration.

Figure 1

74


Series 3 Plus Dimensions

B

10 cu. ft. (280 liters) Inner - 24.5”W(622mm) x 23.5”D(597mm) x 29”H(737mm) Outer - 28.5”W(745mm) x 25.75”D(654mm) x 39”H(991mm)

39" (991mm)

29" (737mm)

24.5" (622mm)

10 cu. ft. Base Cabinet (280 liters) Inner - 24.5”W(622mm) x 23.5”D(597mm) x 19”H(483mm) Outer - 28.5”W(745mm) x 25.75”D(654mm) x 29”H(737mm)

35" (889mm) Base Cabinet

a: Without printer

28.5" (724mm) b: With printer 34.75" (883mm)

6 cu. Ft (168 liters) Inner - 24.5”W(622mm) x 23.5”D(597mm) x 19”H(483mm) Outer - 28.5”W(745mm) x 25.75”D(654mm) x 29”H(737mm)

B

29" (737mm)

19" (483mm) 24.5" (622mm)

23.5" (597mm)

a: Without printer

28.5" (724mm) b: With printer 34.75" (883mm)

25.75" (654mm)

Figure 2 75

Heat Sealer


Replaceable Teflon heatstrip and wire element

30”

41”

20”

Replaceable heat element and Teflon strip: Part No. AN1199 Power Usage: 110 VA @ 60Hz 7.5 Amps

Wt: 17lbs/7.7kg

Dimensions: 30"x20"x41" / 75x50x102.5cmcm 75x50x102.5cmcm

Figure 3 76

Vacuum Sealer


AN5026 Vacuum Sealer The AN5026 Andersen Vacuum Sealer is self-contained, easy to maintain, and allows multiple configurations configuration s for a wide range of applications. The sealer has a 26” seal length and is available in both 110V and 220V models. 9 preset jaw pressure, heating and cooling settings are easily changed by the user. Optical safety switches protect the operator’s fingers during sealing.

Features: No pneumatic cylinders; cylinders; Self-contained, no shop air or vacuum source needed; Easy to maintain, user serviceable sealer wire; wire; Easy to use, Digital display and Digital control; May be connected to gas flush or external vacuum vacuum source if desired.

Shipping Wt: 392 lbs / 178 kg Dimensions: Footprint—32” (81.28 cm) W, W, 28.5” (72.4 cm) D. Height—45.5” (115.6 cm). Total Front to Rear—40.5” (102.9 cm). Work Surface—27” (68.6 cm) cm ) D.

Figure 4

77


EOGas Installation Venting through an outside wall

Discharge should be vertical to assist dilution and dispersion Ventilation unit 3 inch plastic pipe to discharge point

3 inch PVC drain pipe tee

Rain trap 45 degree PVC elbows 3 inch PVC pipe Clamp and brace pipe as necessary for mechanical security and to conform with local codes 3 inch PVC pipe

Exterior wall Plywood panel mounted to wall with masonry screws

Installation shown using up to 70 feet equivalent length of

A rain trap must be installed at some point in the line or some provision made to prevent accumulation of rain water in pipe.

Figure 5 78


EOGas Installation Venting to the outside within an interior wall

Surface mounted discharge piping

Discharge should be vertical to assist dilution and dispersion Mount on sheet rock wall using 4 molly type bolts

3 inch plastic pipe to discharge point

Height to conform with local regulations -3 foot minimum above roof line

Rain trap Ventilation unit

3 inch PVC pipe

3 inch PVC 90 3 inch PVC 90 degree elbow

Clamp and brace pipe as necessary for mechanical security and to conform with local codes

Note: a rain trap must be installed at some point in the line, or some other provision made to prevent accumulation of rain water in pipe

Installation is shown inside a typical commercial building with a flat roof, using surface mounting techniques. Alternately the vent piping piping may be installed within a hollow wall (ie., sheetrock). 3 inch PVC plastic plastic drain pipe is suitable for up to 70 equivalent feet of pipe.

Surface mounting using U-shaped channel spacer

Figure 6 79


Figure 7 80


EOGas Sterilizer Parts (top) 2

1

5

3

27

4

6

7

8

9

12 V Light

10

12 V Light Gear Motor

28

BELOW!

15 BELOW! BELOW!

13

13 25

18

24 19 30 11

32 12

17

16

Control Circuit Board

26

14 29

31

23 # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

21

PART NAME Valve Plate - Inlet Vent Stack - Inlet Valve Shaft Valve Plate - Exhaust Vacuum Switch Vent Stack - Exhaust Flexible Coupling Vent Motor Limit Switch Gear Motor Cabinet Light Unit SS Relay Lights Circulation Fan Capacitor Circulating Air Heater (2) SS Relay - Fan Circulation Fan

20

22 PART NO. 2637 2635 2716 2636 3878 2622 2628 2670 2643 3890 1220 3901 3212(3224) 1210 3792

# 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

PART NAME PART NO. SS Relay - Heater 1220 Power Supply Circuit 3721 Temperature Sensor 4143 Computer Circuit Printer Unit 3833 Membrane Switch Panel 3725 Vacuum Flourescent Display 3891 Door Lock Assembly 2647 Label Label Printer Data Connection 3896 Label Printer Power Connection 3641 Label Printer 3897 Receptacle - Extractor Supply 3020 EMI Filter/Switch/Fuseholde Filter/Switch/Fuseholderr 1047 Lighting Transformer 3902 Circuit Breakers (see schematic) Alarm Unit 1030 81 Connector 2688

Figure 8

EOGas Extractor Unit (cover removed)


1

2

3

4 No. 1 2 3 4

Part Number Blower cover box Blower Motor, shaded pole Mounting Brackets 3” Dia. Hose

Order No. 2788 2787 2791 2786

Figure 9 82


Gas Disposal System

Outside Air

Abator

Blower

EOGas Sterilizer

Figure 10 83


Equipment Ratings Summary Equipment Rating: Model Ref.

Voltage

Hz

Current___

AN306.01P AN306.01P AN306.11P AN306.11P

110/120v 110/120v 220/240V 220/240V

50/60 50/60

10.75Amp. 10.75Amp. 5.40Amp. 5.40Amp.

AN310.01P AN310.01P AN310.11P AN310.11P

110/120v 110/120v 220/240v 220/240v

50/60 50/60

10.75Amp. 10.75Amp. 5.40Amp. 5.40Amp.

Environmental Environmental Conditions: The EOGas Sterilizers are designed to function in an environment with these conditions: Temperature.....................................10ºC to 40ºC Use....................... Use................................... .......................... ................Indoor ..Indoor Relative Humidity............................. 80% to 30% Main Supply Voltage........................ Not to exceed +/- 10% of nominal voltage Transient Overvoltages..................... As IEC Installation Category............... Category.........................II ..........II Pollution Degree...............................2 Altitude................ Altitude.............................. .......................... ...............Operate ...Operate up to 2,000 2,000 m above above sea level level Connections: Input:

Power cord 3 x 16AWG 16AWG 13Amp to 320 with cabinet power entry EMI Filter 10A 115/250v 50/60Hz

Output: Receptacle to extractor unit VDE 1930 - 10A 250AC Data Connector to remote Label Printer DB IDC 25 pin Connector Power Connector to remote Label Printer 14v AC DIN Connector, 3 pin Lock Ring Sound Level: Operating Condition: (2 feet from unit front panel) 55 dB Incoming Power Fuses: 120v Models: 12Amp ABC - 3AB Fast Acting 240v Models: 6.3Amp GDA - IEC 127-2 Sheet 1

Figure 11 84


Sterilizer Controls Layout

Front

Power Cable Run In Hose

Gas Extra Gas Extractor ctor Unit U nit (wall mounted)

Key Pad

Display

Panel-Mounted Printer

Label Printer Power Supply Cable Label Printer Data Cable

SETUP

Label Printer

LOAD

UNLOAD

ENTER

Rear

On/Off Switch Input Power Receptacle & Fuseholder

Gas Extractor Power Recept Receptacle acle

Figure 12 85

Vacuum Transducer Board


Figure 13 86


Schematic C

D

2 E A S 1 U 2 F 6

B

A

H C T I W S R E W O P

C A V 5 1 1

D R A O B Y L P P U S R E W O P

1 E A S 2 U 1 F

G U L P

E L C A T P E C E R

Y ) L C P A P U V S 0 4 R 2 E 0 W 0 1 ( O P

C D V 5 + 5

2 1 K 1 1 K 0 1 K 9 K

C D V 2 1 +

2 P M A L

7

1 1

2 1

1

2

5

6

1 P M A L

T H G I L 2 R E T A E H

3

R E W O L B

R E L L O H R C T T N I W O C S R O E M W R E O H P T L = A N W O S I T T R O P O R P = C P P

5

A 5 . 2

4

R E T N I R P E P A T

R O T T I R C A A T P S A C C P P , R E T A E H

R M D U S O R U N A C E O A S B V

1 ) R W E 0 T 0 6 A X E H ( 2

1 D

E R U T R A O R S E N P S E M E T

Y L 2 P P W U S S R E W O P 2 D

D F V

N R B E U L C L P O E R N T O N I S O R C E V

R O C T D O M

V 0 1 0 C / 1 F u 0 1

1 W S

N A F 3

N A F N O I T A L U C R I C

2 W S T 1 W S T

2

D A P Y E K

C D V 0 2 +

R R O O S O N E D S

R O D N A T R O I U P A S A A O R P D B E E A V

D I O K C N O E L L O S

1

R L E E T B I A N R L P

D

: e : e e z B t a l i S D i F

N O I S T U C L E P S 3 P S O A T G T O E E N I B A C

A 6 . 1

1 T

4

S P U

8

e l t i T

A 5 . 0 A 5 7 . 0

C A V 2 1 +

2

A U ) S V P 5 n o E 1 i i v s e e 1 R e L ( . 1 L : 6 f y M 1 o B E t e e n a w T h r S S D Y S S U B L D P D . A U 3 S P E \ S 6 e r 0 a A b e r 0 2 w - d b r m e a G N u F H - \ : O 2 2 C E

C

B

1

M R A L A

A

120V Figure 14

87


Schematic C

D

2 E A 3 S . U 6 F 6

B

A

H C T I W S R E W O P

C A V 0 3 2

D R A O B Y L P P U S R E W O P

1 E A 3 S . 6 U F

G U L P

E L C A T P E C E R

Y ) L C P P A U V S 0 4 R 2 E 0 W 0 1 O ( P

C D V 5 + 5

2 1 K

C D V 2 1 +

C A V 2 1 + 7

8

1 1

2 1

2

5

6

1 T 1

4

S P U

1 P M A L

T H G I L 2 R E T A E H

3

R E W O L B

R E L L H O R C T T N I W O C S R O E M W R O E H P T L = A N W O S I T T R O P O R P = C P P

5

4

R E T N I R P E P A T

R O T T I R C A A T P S A C C P P , R E T A E H

R M D U S O R U N A C E O A S B V

1 ) R W 0 E 0 T A 6 E X H ( 2

1 D

E R U T R A O R S E N P S E M E T

Y L 2 P P W U S S R E W O P 2 D

D F V

N R B E U L C L P O E R N T O N I S O R C E V

R O C T D O M

V 0 1 0 C / 1 F u 0 1

1 W S

N A F 3

N A F N O I T A L U C R I C

2 W S T 1 W S T

2

D A P Y E K

C D V 0 2 +

R R O O S O N E D S

R O D N A T R O I U P A S A A O R P E E D B V A

D I O K C N O E L L O S

1

R L E E T B N A I R L P

D

e e z B t a l i S D i F

N O I S T U C L E P S 3 P S O A T G T O E E N I B A C

1 1 K A 5 7 . 0 0 1 K A 5 . 2 9 K

2 P M A L

e l t i T

A 3 . 0 A 5 . 0

2

) V A 0 E 3 S 2 P ( n o E s e i e M i v e L . E R 1 L T : 6 f y S o B n t Y 1 w e e a r S h S D 3 3 3 N A / S B D U D . A L U S P P E \ 3 e 6 r 0 a r 0 e 2 w S b - d b r m e a A N u F H - \ : 2 C G 2 O E : e :

C

B

1

M R A L A

A

88

240V Figure 15


EOGas Series 3 Plus - Replacement Parts List This list relates to Models: AN306.01, AN306.01, AN310.01 AN310.01 (110/120V) (110/120V) AN306.11, AN306.11, AN310.11 AN310.11 (220/240V) (220/240V) Part No. 3212 3224 3721 3722 3924 2643 2670 1007 4288 1047 3020 1048 4057 2787 2696 2647 3902 3085 1220 4650 3833 3732 3114 3716 3879 4119 4294

Description Descripti on Circulating Circulat ing Air Heater 110v - Chromalox 052710-003 Circulating Circulat ing Air Heater 220v - Chromalox 052710-006 Power Supply - Integrated Power Design - SRW-115-2006 Circulating Circulati ng Fan 110v - EBM R2E175-AE47-13 CSA 43145 Circulating Circulati ng Fan 220v - EBM R2E175-AE1-14 Vent Gearmotor 12v - Pittman GM9413-5 Vent - position microswitch microswi tch - Cherry D44L RIRA Power Cord 110v - Belden IEC 320-C13/ NEMA 5-15P Power Cord 220v - Belden IEC 320-C13/ CEE7 standard VII Power Receptacle - Qualtek 864-10/011 EMI Filter, fuse, switch CSA 75100 Vent Cord Receptacle - Qualtek 710-00/63 Vent Cord Plug - Qualtek 711-00/00 Vent Power Cable - New England Elect Corp 3/14WG 7x24/40 tinned copper 0.010 hytrel to 0.072 OD 0.030 polyurethane jacket Vent Blower Motor 110v - Dayton 4C442 CSA 6319 Vent Blower Motor 220v - Dayton 2C915A CSA 6319 Door Lock Solenoid 12v DC - Ragdon 6211/8948 Lighting Transformer 110/220v - Signal A41-43-12 CSA 51265 Vacuum Fluorescent Display - Futaba M202M00113 Solid State Relay - NTE RS3-1D25-24T CSA 59793 Control Circuit Board - Andersen Products Data Printer - Zebra LP2722 Data Printer - Replacement Paper Roll (5 per pack) Data Printer - Replacement Cassette Proximity Proximi ty Switch - Banner 1FR 12.24 11L Label Printer - Zebra LP2722 Label Printer - Replacement label roll - 2" width HEPA Air Filter Replacement cartridge

Figure 16 89


IEC WARNING SYMBOLS

Number

Symbol

1

Publication

Description

IEC 417, No. 5031

Direct Current

2

~

IEC 417, No. 5032

Alternating Current

3

~

IEC 417, No. 5033

Both Direct and Alternating Current

4

3

~

IEC 617, No. 02-02-06 Three-phase Alternating Current

5

IEC 417, No. 5017

Earth (ground) TERMINAL

6

IEC 417, No. 5019

Protective Conductor TERMINAL

7

IEC 417, No. 5020

Frame or Chassis TERMINAL

8

IEC 417, No. 5021

Equipotentiality Equipotentiality

9

IEC 417, No. 5007

On (Supply)

10

IEC 417, No. 5008

Off (Supply)

11

IEC 417, No. 5172

Equipment protected throughout by DOUBLE INSULATION or REIN FORCED INSULATION (equivalent to CLASS II of IEC 536-see annex H)

ISO 3864, No. B.3.6

CAUTION, risk of electric shock

12

Background color - yellow; Symbol and outline - black

13

Symbol under consideration

Easily touched, higher temperature parts

!

14

Background color - yellow; Symbol and outline - black

ISO 3864, No. B.3.1

CAUTION (Refer to Accompanying Documents)

Figure 17 90


EOGas SERIES 3 Plus - ROUTINE MAINTENANCE SCHEDULE Recommended every six months Mechanical:

(Refer to the Torque Settings Schedule on the cabinet top panel.) Check the tightness of:

Check: Confirm Confirm Confirm

1. Cabinet door hinge mountings 2. Inner door hinge mountings 3. Inner door lock mountings 4. Exhaust Unit wall mount screws 5. Exhaust Unit blower motor bolts 6. Exhaust Unit UPS mounts 7. Exhaust hose clamps 8. Component Module Attachment screws 9. Vent gear motor mounts 10. Vent valve shaft coupler 11. Vent Valve plates 12. Top Cover fittings 13. Door proximity switch mount 14. Door solenoid lock mount

1. Wear of cabinet door bushings 2. Alignment of door top lock striker plate 3. Security of shelf fixings 4. Exhaust hose wear

Electrical: 1. Check the operation of the circulating fan for bearing wear or binding 2. Check the proximity switch stops the circulating fan with the door open 3. Check the ventilation alarm circuit by switching off the exhaust fan 4. Isolate each circuit by opening the circuit breakers then restore 5. Disconnect power to the UPS, confirm back up capacity time 6. Check calibration setting of cabinet temperature at shelf point Replace: 1. Air inlet HEPA Filter 2. Data Printer paper roll 3. Data Printer ink cassette 4. Label printer roll stock Calibrate: 1. Temperature of Cabinet (see page 23)

Figure 18 91


Appendix A Material Safety Data Sheets—Ethylene Oxide Section 1 Chemical Product & Company Identification Product: EOGAS Manufactured by: Andersen Sterilizers, Inc. Health Science Park 3154 Caroline Drive Haw River, NC 27258 USA

Statement of Hazards: DANGER! Extremely flammable liquid and gas under pressure. May form explosive mixtures with air. Highly reactive. May be harmful if inhaled and may cause delayed lung injury, respiratory system and nervous system damage. Inhalation may cause dizziness or drowsiness. 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 reproductive hazard. HAZARD RATINGS : (0 = minimum; 4 = maximum)

Information Telephone Number: (336) 376-8622 HMIS RATING : 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 (CH2)2O 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 antifreeze, polyester resins, non-ionic surfactants and specialty solvents; sterilizing agent f or controlling microorganisms in health care applications; fumigant for controlling insect infestation in whole and ground spices and cosmetics.

Section 3 Hazard Identification Identification

EMERGENCY OVERVIEW Colorless liquid or heavier-than-air gas with a sweet, ether-like odor. Extremely flammable liquefied liquefied gas which burns in the absence of oxygen and can explode when exposed to elevated temperatures. 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.

Health = 3 Flammability = 4 Reactivity = 3 Personal Protection Code = x (Consult your supervisor or standard operating procedures for special handling directions.)

NFPA RATING : Health = 3 Flammability = 4 Reactivity = 3 Exposure Limits: TWA (8 hr) OSHA 1 ppm ACGIH 1 ppm

STEL (15-min) 5 ppm n/a

PRIMARY ROUTES OF EXPOSURE: EXPOSURE : Inhalation; eye contact, skin contact/absorption SIGNS AND SYMPTOMS OF OVEREXPOSURE: Effects include skin, eye and respiratory trac t irritation or burns. Central nervous system effects initially cause headache, dizziness and nausea and in extreme c ases, unconsciousness and death. death. Peripheral nerve damage may result in muscular weakness, giddiness, irrational behavior and loss of sensation in in the extremities. Dulling of the sense of smell may occ ur. ACUTE HEALTH EFFECTS: INHALATION: Inhaling concentrated vapor may cause serious health effects. effects. Inhalation may progressively cause mucous membrane and respiratory irritation, headache, vomiting, cyanosis, drowsiness, weakness, incoordination, CNS depression, lachrymation, nasal discharge and salivation, gasping, and labored breathing. Delayed effects may include nausea, nausea, diarrhea, edema of the lungs, paralysis paralysis and convulsions. NOTE: Ethylene oxide has a high odor threshold (>250 ppm) and the sense of smell does not provide adequate protection against its toxic effects.

Figure 15 92


EYE CONTACT: Liquid ethylene oxide is severely irritating and corrosive to the eyes and contact can cause swelling of the conjunctive and irreversible corneal in jury. Contact with liquid ethylene ethylene oxide can cause frostbite. Vapors may cause eye irritation, tearing, redness and swelling of the conjunctive. SKIN CONTACT: Prolonged contact with liquid ethylene oxide can cause a local erythema, edema, and formation of blisters. Response is more severe on damp damp skin. There may be a latency latency period of several hours prior to the onset of symptoms. Ethylene oxide may be be absorbed by the skin, and sustained c ontact may produce adverse effects such as headache, dizziness, nausea, and vomiting. Ethylene Oxide is a skin sensitizer sensitizer and some individuals may suffer an allergic skin reaction. Skin contact may also cause allergic contact dermatitis in some exposed 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: 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 reported. 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: INGESTION: May cause anemia, gastrointestinal irritation, effects on liver, kidneys, and adrenal glands. CARCINOGENICITY: CARCINOGENICITY: OSHA classifies OSHA classifies ethylene oxide as a cancer/ reproductive hazard and considers that, at excess ive levels, ethylene oxide may present reproductive, mutagenic, genotoxic, neurologic and skin sensitization hazards. ACGIH classifies ethylene oxide as “A2”- sus pected human carcinogen. NTP classifies NTP classifies ethylene oxide as a known human carcinogen. IARC classifies 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 surface of the eyes and under the eyelids, gently but thoroughly with plenty of running water for at least 15 minutes. Obtain medical attention immediately. immediately. NOTE: Never wear contact lenses when working with ethylene oxide. SKIN CONTACT: Immediately flush skin thoroughly with water for at least 15 minutes while removing contaminated clothing and shoes. shoes. Obtain medical attention attention immediately. Wash clothing before reuse 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 VOMITTING . This material is corrosive. Keep head lower than hips to avoid aspiration, should vomiting occur. Get medical attention attention immediately. immediately. MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: 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. administration. If a chemical burn is present decontaminate skin and treat as any thermal thermal burn. No specific antidote antidote is known, however 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 flammable limit: 100% Lower flammable limit: 3.0% (30,000 ppm) NEFA HAZARD RATING: Health: 3 Flammability: 4

Reactivity: 3

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AUTOIGNITION TEMPERATURE: TEMPERATURE: 804 F (429C); burns in the absence of air EXTINGUISHING EXTINGUISHING MEDIA: Carbon dioxide, dry chemical or water spray for small small fires. Water spray, polymer or alcohol resistant foams for for large fires. Dilution of liquid ethylene oxide with 23 volumes of water should render it non-flammable. Dilution with 100 parts water to one part of ethylene oxide v apor 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 containers 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 absence 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 not be subject to temperatures hotter than 127F (52 C). C). Vapors are extremely flammaflammable and are readily ignited by static charge, sparks and flames at concentrations above 3%.

ENGINEERING ENGINEERING CONTROLS: Ethylene oxide, a major fire hazard, can burn in the 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 electrical/fire codes. Safeguards can include designing electrical devices as explosion proof and/or intrinsically safe. ATTENTION: Ethylene oxide vapors are colorless and odorless above OSHA’S OSHA’S permissible exposure exposure level. An air monitoring system and/or AirScan® badges are recommended 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. ignition. Store EOGas refill 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 EOGas refill refill kits containing ethylene 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 Controls/Personal Protection Protection

Section 6 Accidental Release Measures Measures PRECAUTIONS: Treat any ethylene oxide leak as an emergency. Evacuate all personnel from the area. If an EOGas cartridge is inadvertently dropped and activated before it is sealed inside of the sterilization liner bag, it must be sealed in a liner bag immediately (within 30 seconds) or the room must be evacuated for a minimum of 12 hours. If an EOGas cartridge is inadvertently dropped and activated, it may be placed in an empty liner bag and the bag c losed by any secure method. This must be completed within 30 seconds. At that point the bag should be placed in the machine and a cycle should be started. Run a full 16 hour cycle cycle before removing the used EOGas cartridge from the liner bag.

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 sterilizer is properly grounded. Protect containers from physical damage and regularly inspect them for cracks or leaks.

EXPOSURE LIMITS: LIMITS : OSHA ACTION LEVEL (8 HR. TWA) OSHA PEL (8 HR TWA) OSHA 15 MINUTE EXCURSION LIMIT ACGIHTLV/TWA ACGIHTLV/TWA IDLH:

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

EYE PROTECTION: PROTECTION : NEVER WEAR CONTACT LENSES when LENSES when working with ethylene oxide. VENTILATION: Install and operate general and local exhaust ventilation systems powerful enough to maintain airborne levels of ethylene oxide below the OSHA PEL in the worker’s breathing breathing area. AAMI / ANSI ANSI ST41 Good Hospital Practice: Ethylene Oxide Sterilization and Sterility Assurance Guidelines, Section 3.4 recommends a minimum of 10 room makeup air changes per hour. Emission controls must must be in compliance with Federal State and local regulations. OTHER PROTECTION: 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.

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Section 9 Stability and Reactivity Reactivity Boiling Point: 50.9ºF (10.5ºC) Freezing Point -169º F (-111.7ºC) Specific Gravity: 0.871 at 20ºC Vapor Pressure: 1094 mm Hg @ 20ºC 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/ liter in water) Appearance and Odor: Colorless liquid or gas with sweet etherlike odor. Odor threshold: 261 ppm (detectable); 600700 ppm recognizable). Log Octanol/Water Partition Coefficient (log Kow): -0.3 STABILITY: Material is stable for extended periods in closed airtight, pressurized containers at room temperature, under normal storage and handling conditions. Vapors may explode when exposed to c ommon 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 TOXICOLOGICALTOXICOLOGICAL- ACUTE INHALATION: LC50 (1 hr. exposure) 5748 ppm (male rat) 4439 ppm (female rat) 5029 ppm (rat – combined sexes)

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: SympTOXICOLOGICAL-CHRONIC toms of chronic exposure are s imilar 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 ex posure. TOXICOLOGICAL-ACUTE TOXICOLOGICAL-ACUTE DERMAL: No dermal LD50 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. TOXICOLOGICALTOXICOLOGICAL- EYE: No eye irritation animal data are available on this product; however, it is expected to be extremely irritating to rabbit eyes. TOXICOLOGICAL-ACUTE TOXICOLOGICAL-ACUTE INGESTION: The acute oral LD50 for This product is; 72 mg/kg, rat. TOXICOLOGICAL-CHRONIC INGESTION: The effects TOXICOLOGICAL-CHRONIC 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 c ancers 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 the evidence does not indicate that ethylene oxide causes these cancers, there are some s uggestive 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 incidences of mono-nuclear cell leukemia, periteoneal mesotheliomas , and primary brain tumors. In 2-year inhalation studies studies with mice there was evidence of carcinogenic activity as indicated by doserelated incidences of benign or malignant neoplasms of the uterus, mammary gland, and hematopoietic system (lymphoma).

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MUTAGENICITY: While ethylene oxide has demonstrated, in epidemiological studies with exposed workers, an increased incidence of chromosomal aberrations and sister chromatid exchanges, the relevance of such effects to human health hazard evaluation is currently uncertain. In rodent studies, studies, dose related exposure to ethylene oxide induces increases in numbers of adducts in DNA and hemoglobin. Laboratory studies with with mice have shown that acute exposure to ethylene oxide at 300 ppm and above caus ed testicular injury as evidenced by concentration-related increased embryonic deaths following mating of exposed males to nonexposed 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 s mell and/or taste may also result. Studies on workers Indicate that CNS and co gnitive impairment may result from chronic exposures to ethylene oxide. REPRODUCTIVE EFFECTS: Some limited epidemiological data suggests that women exposed to ethylene oxide have a greater greater incidence of miscarriages. miscarriages. A onegeneration reproduction study in rats showed decreased number of pups at 100 ppm, but not at 33 ppm. 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 p pm 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, reproductive system, and central nervous system.

Section 11 Ecological Information Information ECOTOXICOLOGICAL ECOTOXICOLOGICAL DATA: Ethylene oxide hydrolyzes to ethylene 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 Consideration WASTE MANAGEMENT/DISPOSAL: MANAGEMENT/DISPOSAL: Dispose used EOGas cartridges, sterilization liner bags, indicators and accessories as you would ordinary trash. However, unused EOGas cartridges containing ethylene oxide are a RCRA RCRA hazardous waste with waste code U115 (Commercial chemical product - listed for toxicity and ignitability). Unused EOGas cartridges containing ethylene oxide may be incinerated in an approved hazardous waste incinerator or can be biologically treated in an approved facility. Unused EOGas cartridges containing 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 con forms to 49 CFR 173.4” See section 7, “Handling and stor age” CA-9803005

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EOGas™ Series Plus Owner’s Manual Section 14 Regulatory Information U.S. REGULATIONS: 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 catego ries met: Acute, Chronic, Fire, Reactive, 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 ACGIH - American Conference of Governmental Governmental Industrial Hygienists CERCLA - Comprehensive Environmental Response, Compensation and Liability Act. CAS - Chemical Abstract Service CFR CFR - Code of Federal Regulations CNS - Central Nervous System DOT DOT - U.S. Department of Transportation EPA - U. S. Environmental Protection Agency HMIS - Hazardous Materials information Sheet IARC IARC - International Agency for Research on Cancer IDL - ingredient Disclosure List IDLH IDLH - Immediately dangerous to life and health HAP - Hazardous Air Pollutant 50 - Median lethal dose that kills 50% of an exposed LC 50 population by the inhalation route LD50 - Median lethal dose that kills 50% of an exposed population by the oral (or dermal) route

NESHAPS - National Emission Standards for Hazardous Air Pollutants NFPA - National Fire Protection Association NIOSH NIOSH - National Institute of Occupational Safety and Health NTP NTP - National Toxicology Program OSHA - Occupational Safety and Health Administration p/p - parts per part PEL - Permissible exposure Limit PVC PVC - Polyvinyl chloride ppm - Parts per million p.s.i.g p.s.i.g - Pounds per square inch (gauge pressure) RCRA - Resource, Conservation and Recovery Act SARA - Superfund Amendment and Reauthorization Act of 1990 STELSTEL- Short-term exposure Limit TDG -Transportation of Dangerous Goods TLV 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: 04/07/2006

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 Section 14 of this document may not be all inclusive and are subject to change. The data in this MSDS MSDS is furnished gratuitously gratuitously independent of any sale of the product only for your investigation and independent independent verification. While the information is believed to be correct, Andersen makes no representation as to the accuracy of the information contained herein. Andersen shall in in no event be responsible for any damages of whatsoever nature directly or indirectly resulting from publication or use of, or negligence upon data data contained herein. 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.

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EOGas™ Series Plus Owner’s Manual ANDERSEN One-Year Limited Warranty Andersen Products, Inc. (“Andersen”) (“Andersen”) warrants that this EOGas® Sterilizer (“Product”) is free from defects in material and workmanship that result in Product failure during normal usage, a ccording to the following terms and conditions: 1. The limited warranty for the Product extends for ONE (1) year beginning on the date of the purc hase of the Product. 2. The limited warranty extends to the original purchaser of the Product (“Consumer”) and is not assignable or transferable to any subsequent purchaser/end-user. 3. The limited warranty extends only to Consumers who purchase the Product in the United States, Canada and Japan, 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 re placement items if such repair or replacement is needed because of product malfunction or failure during normal 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 replacing the defective parts. The limited warranty does not cov er defects in appearance that are cosmetic or decorative. Andersen's limit of liability under under the limited warranty shall be the actual cash value of the Product at the time the Consumer 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 c ost 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 s ubject to abnormal use, abnormal conditions, improper storage, exposure to moisture or dampness, unauthorized modifications, unauthorized connections, un-authorized repair, misuse, neglect, abuse, accident, 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 recommended 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 procedure: 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 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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EOGas™ Series Plus Owner’s Manual 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 estimate 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 Andersen after the expiration of the limited warranty period, Andersen's normal service policies s hall apply and the Consumer will be responsible for all shipping c harges. 9. The Product consists of newly assembled equipment that may contain us ed components that have been reprocessed 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. WARRANTY. OTHERWISE, THE FOREGOING LIMITED WARRANTY IS THE CONSUMER'S SOLE AND EXCLUSIVE REMEDY AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS EXPRESS OR IMPLIED. IMPLIED. ANDERSEN ANDERSEN SHALL NOT BE BE LIABLE FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO, LOSS OF ANTICIPATED 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 SUBSTITUTE 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 PRODUCT OR ARISING FROM BREACH OF THE W ARRANTY, BREACH OF CONTRACT, NEGLIGENCE, NEGLIGENCE, STRICT TORT, OR ANY OTHER LEGAL OR EQUITABLE THEORY, EVEN IF ANDERSEN KNEW 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 REPAIRED. 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 Consumer). 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 s ervice center or any other perso n or entity to assume for it any other obligation or liability beyond that which is expressly provided for in this limited warranty including 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 c ontemporaneous agreements or understandings, oral or written, and all communications relating to the Product, and no representation, 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 allocation 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 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: [email protected] 17. The limited warranty period for Andersen supplied attachments and accessories is specifically defined within their own warranty cards and pack aging.

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ANPRO Andersen Products EcoGas 3 Sterilizer User Manual

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