Manuel d'utilisation / d'entretien du produit AN74I du fabricant Andersen Sterilizers
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OW NER’S MANU AL 5/25/ 2005 1 1: 38 AM AN 2000manua l071 603bg f ETHYLENE OXIDE STERILIZA TION S Y STEM Andersen Sterilizers, Inc. Health Science Park Haw River, NC 27258-8710 P/N7400 041105 OWNER.
2 OW NER’S MANU AL Know ing how to pr oper ly use the A npro lene sy stem is im portant. With this in mind, we ha ve inclu ded th e Operator Tra ining and E ducatio n Section f ound in Secti on 4, beg inning on pag e 17. I llustrated instru ctions a nd i nform ation on humidif icat ion are inclu ded in t he tra ining sectio n.
3 OW NER’S MANU AL Latching Door Lock Back Lighted Liquid Crystal Display On/Off switch Velcro ® strap Quick Disconnect Door Support Program Selection Switches Door Sensor Top Cabinet Overview of Features Purge Tube Assembly Fuse Drawer 3/4” (1.91 cm) I.
4 OW NER’S MANU AL TABLE OF CONTENTS Introduction ............................................................................................................................ 2 Overview of Features....................................................
5 OW NER’S MANU AL SECTION 1 Before Y ou Begin... © Andersen Products Ltd.
6 OW NER’S MANU AL SECTION 1 Before You Begin There are a number of conditions that can affect the operation of your sterilizer. By paying close attention to these details, you will greatly reduce the likelihood of problems. 1.1. Installation: Please make sure that your Anprol ene sterilizer is installed cor- rectly .
7 OW NER’S MANU AL SECTION 1 Before You Begin There are a number of conditions that can affect the operation of your sterilizer. By paying close attention to these details, you will greatly reduce the likelihood of problems. 1.1. Installation: Please make sure that your Anprol ene sterilizer is installed cor- rectly .
8 OW NER’S MANU AL SECTION 2 Diagrammatic Instructions for Normal Operation © Andersen Products Ltd.
9 OW NER’S MANU AL SECTION 2 Diagrammatic Instructions for Normal Operation Turn on the sterilizer by pressing the on- off switch on the back right side of the top cabinet. The Liquid Crystal Display will illuminate. The initial startup and standby screen is shown to the right.
10 OW NER’S MANU AL After the initial purge, the screen to the right will appear. If the operator break s the am poule and closes the door without selecting a cycle length, the sterilizer w ill beep after 5 seconds to remind the operator to select the appro- priate cy cle length .
11 OW NER’S MANU AL Diagrammatic Abator Instructions: Installing Optional New Abator Cartridge, Resetting Counter When the Abator cartridge has been used completely (250 sterilization c y cles), the screen will display ABATOR CARTRIDGE EXPIRE D and the alarm w ill sound.
12 OW NER’S MANU AL SECTION 3 Detailed Pictorial Instructions for Running a S terilization Cycle © Andersen Products Ltd.
13 OW NER’S MANU AL Once the items to be sterilized have been di sassembled, cleaned, dried and wrapped, the ster- ilization cycle can proceed. 3.1 Prior to loading the sterilizer: (1) Turn th e power ON by pressing the right side of the black power switch located on the back right corner of the machine.
14 OW NER’S MANU AL 3.3. Insert the purge tube into the sterilization liner bag with the plastic ball towards the rear of the bag and the neck towards the opening. Then, gather the open end of the sterilization liner bag around the aluminum neck of the purge tube, taking care to ensure you have left no openings.
15 OW NER’S MANU AL 3.11. The sterilization cy cle will then begin. Note: After the ampoule is activated and the door is closed, if the operator does not select a cycle length within 5 seconds, a continuous alarm will sound to remind the operator to select the appropriate cycle time.
16 OW NER’S MANU AL 3.13. At the end of the two hour ventilation cy cle, the following screen will appear, notifying the operator that the sterilizer may be unloaded.
17 OW NER’S MANU AL SECTION 4 Operator T raining and Educa tion © Andersen Products Ltd.
18 OW NER’S MANU AL SECTION 4 Operator Training and Education ♦ Ethylene Oxide sterilization procedures mu st be supervised by personnel trained and well informed in the safe use o f such sterilant m aterials. ♦ Personnel working with ethylene oxide m ust have had comprehensive instruction in the process.
19 OW NER’S MANU AL 4.1 Humidity and Pre-humidification 4.2 Abridged Illustrated Instructions 4.3 Key Operator Study Guide 4.1. Humidity and Pre-humidification.
20 OW NER’S MANU AL 4.2 ABRIDGED ILLU STRATED INSTRUCTIONS HOW ANPROLENE WORKS 1. The glass amp oule contains l iquid Ethy lene Oxide (EtO) and an inert sol id stabilize r. The ampou le is scored at the n eck for easy opening. 2. A plastic/fa bric break shie ld surrou nds the ampoule.
21 OW NER’S MANU AL 4.2 ABRIDGED ILLU STRATED INSTRUCTIONS HOW ANPROLENE WORKS 7. EtO gas rea dil y passes t hroug h cloth, paper, a nd Seal and Peel ® Packag ing to reach the items to be sterilized. 8. The walls of the ster ilizati on bag are a lso p orous to EtO gas.
22 OW NER’S MANU AL Thank you for using the Anprolene ® sterilizat ion system. The active ingr edient i n Anprolene is e thylene oxid e ( EtO or EO), a ch emical that can be haz ardous if not handle d properl y.
23 OW NER’S MANU AL A. Environmental Considerations 1) Temperature • Store your Anprolene gas refill kits in a cool, secure area. We recomm end storage below 72°F (22.2°C). • The sterilizer must be used in an area where the temperature is not less than 68ºF (20°C) or more than 91ºF (33°C).
24 OW NER’S MANU AL 3) Dry Two accepted ways to dry any item prior to sterilization with Anprolene are: 1. Towel drying 2. Drain drying (air drying).
25 OW NER’S MANU AL 4. Insert the purge tube into the sterilization liner bag with the aluminum bobbin and quick release fitting at the open end. Place the black Velcro® strap around the sterilization liner bag and the bobbin of th e purge tube, and pull it snug though its loop to close the sterilization liner bag.
26 OW NER’S MANU AL 4) Unloading the Sterilizer and Determining Sterility 1. Remove the sterilized items only after the sterilization cycle and 2-hour purge cy cle have been completed and the displa y indicates UNLOAD STERILIZER. The sterilizer will continue to aerate items th at are not rem oved immediately.
27 OW NER’S MANU AL ☺ HINT: The AN74 i/ix can be used for extende d aeration. A count-up timer will keep track of the time that has passed since the standard cycle was completed.
28 OW NER’S MANU AL • If a power outage occurs during any part of th e cycle, the sterilizer is equipped with a battery back up on the circuit board that will keep track of elapsed cycle time.
29 OW NER’S MANU AL Things that CAN be sterilized with Anprol ene but that require additional aeration: Any items that are m ad e of rubber, plastic, cl oth, are implanted or co me in direct contact with the skin, require additional aeration.
30 OW NER’S MANU AL SECTION 5 Sundries for Use with Anprolene © Andersen Products Ltd.
31 OW NER’S MANU AL SECTION 5 Accessories for Use with Anprolene Package Closure Indicator Strip Get visual assurance of gas exposure and seal your packages in one step! Strips provide a strong color change through rapid confirma- tion of EtO exposure.
32 OW NER’S MANU AL Humidichip ® Designed specifically for use with Andersen gas sterilization systems, this unique device ensures adequate Relative Humidity during the sterilization cycle. Each single-us e, pre-m oistened, 2”x 2” (5 cm x 5 cm) Humidichip releases up to 4 grams of water vapor.
33 OW NER’S MANU AL If you have questions concerning Andersen St erilization Accessories, contact an Andersen Customer Service Representative at 1-800- 523-1276 or 336-376-3000 or visit our website at www.anpro.com. Seal and Peel ® Packaging / 8” Electric Impulse Heat Sealer Supplies tough, transparent, waterproof s ealed package.
34 OW NER’S MANU AL SECTION 6 W arnings, T roubleshooting, Error Messages and Alarms © Andersen Products Ltd.
35 OW NER’S MANU AL SECTION 6 Warnings, Troubleshooting, Error Messages and Alarms Pre-Cycle Error Messages (Before the am poule is broken) 6.1. Vent Sensor Failure 6.2. Purge Sensor Failure 6.3. Pressure Sensor Failure 6.4. Vent Pump Failure 6.5. Purge Pump Failure 6.
36 OW NER’S MANU AL Pre-Cycle Error Messages (Bef ore the ampoule is broken): The self test portion of the cycle begins when the START button is pressed and e nds after the initial purg- ing of the sterilization liner bag. Ethy lene Oxide has not be en released into the ster- ilization liner bag during the self test.
37 OW NER’S MANU AL Response: The cause of failure must be identified and corrected prior to starting the sterilization cycle. 6.5. PURGE PUMP FAILURE: Failure of the pu rge pump during the self te st por tion of the cycle will show the PURGE PU MP FAILURE m essage on the screen.
38 OW NER’S MANU AL Response: The cause of failure must be identifi ed and corrected prior to starting the sterilization cycle. Error Messages During the Cycle (After the ampoule is activated) 6.
39 OW NER’S MANU AL If examination of the sterility indicators included with the load indicate adequate time/concentration exposure to ethylene oxide , the items in the sterilizer may be con- sidered sterile.
40 OW NER’S MANU AL The ventilation sensor monitors the vacuum between the cabinet ventilation pump and the interior of the cabinet. The pressure within the cabinet relative to the roo m is negative (vacuum) which ensures the steril izing gas which has diffused through the walls of the sterilization liner bag is retained within the cabinet.
41 OW NER’S MANU AL The first purge cycle takes place immediatel y prior to activation of the Anprolene am- poule and commencement of the sterilization c y cle.
42 OW NER’S MANU AL SECTION 7 Maintenance © Andersen Products Ltd.
43 OW NER’S MANU AL SECTION 7 Maintenance 7.1. The cabinet ventilation pump and the steril ization liner bag purge pump have an ex- pected life of 18,000 hours (this translates to approximately five cycles per week for five years).
44 OW NER’S MANU AL APPENDIX A T echnical Features © Andersen Products Ltd.
45 OW NER’S MANU AL APPENDIX A Technical Features A.1. Cabinet : The AN74 i/ix cabinet is assembled from grain finish stainless steel with molded ABS front and rear end plates. The door is assembled from a molded polystyrene outer door and inner stainless steel liner.
46 OW NER’S MANU AL APPENDIX B Installation Re quirements © Andersen Products Ltd.
47 OW NER’S MANU AL APPENDIX B AN74ix Anprolene Sterilizer Dimensions and Clearances and Installation Requirements APPENDIX B AN74i Anprolene Sterilizer Dimensions and Clearances and Installation Requirements Total weight is approximately 50.5 pounds (22.
48 OW NER’S MANU AL APPENDIX B Dimensions and Clearances and Installation Requirements B.1 The AN74 i/ix Sterilizer consists of three major components: (1) a lower cabinet which is used to contain t.
49 OW NER’S MANU AL APPENDIX C Inst allation Instructions for New Anprolene Users © Andersen Products Ltd.
50 OW NER’S MANU AL Confirm that you have the following item s: • Α Ν 7 4 i/ix Anprolene sterilizer uppe r and lower cabinet unit • (A) Eight toggle inserts and Phillips screws to secure the mounting plates. • (B) Exterior wall mounting plate with black plastic bushing.
51 OW NER’S MANU AL C.5 Using a 2” hole saw bit, enlarge the pilot hole on the inte- rior surface of the wall to 2”. Repeat this process on the exterior surface of the wall using the pilot hole as the center point. You should now have a 2” hole through the entire wall.
52 OW NER’S MANU AL C.10 Secure the interior mounting plate assembly to the interior wall by threading the Phillips screws into the four toggles. C.11 Take one end of the eight foot length of 3/4" (1.9 cm) I.D. clear braided PVC tubing and slip one of the stainless steel hose clamps over the end.
53 OW NER’S MANU AL C.17 Press the button next to START and the steril izer will perform a self test on the cabinet ventilation pump. C.16 Turn the sterilizer on with the black power switch located on the back right corner of the upper cabinet. The sterilizer will display the following screen: AN74 I ANPROLE N E STERILIZER START C.
54 OW NER’S MANU AL C.19. At the end of the initial self test, the following screen will be automatically displayed. Pressing the button to the right of PURGE will cause the sterilization bag purge pump to operate for 1 minute, 30 seconds. This, in tur n, will cause air to flow through the steriliza- tion liner bag, up the 1/4" (.
55 OW NER’S MANU AL APPENDIX D Inst allation Instructions for Current Anprolene Users © Andersen Products Ltd.
56 OW NER’S MANU AL D.1.2 This will expose the plastic mounting plate underneath. D.1.3 At the time of initial installation, the 2” pipe leading to the outside should have been sealed with a light coat of silicone caulking and pressed firmly into the hole in the mounting plate.
57 OW NER’S MANU AL D.2.1 Clean the Mating Surfaces. Remove the mounting plate from the wall and clean the outside surface of the 2” PVC pipe as well as the interior surface of the tube extending from the back of the plate with rubbing alcohol and allow to dry.
58 OW NER’S MANU AL D.3.4 Screw in the black nylon 90º hosebarb fitting and align the barb end such that it is pointing down. D.3.3 QUICKLY press the adaptor all the way into the hole. The glue acts as a lubricant, so it will easily slide in. NOT E: There can be no de- lay in sliding the adaptor into the hole after applying the glue.
59 OW NER’S MANU AL APPENDIX E Software/User Interface Flowcharts © Andersen Products Ltd.
60 OW NER’S MANU AL Flowchart for Normal Operating Screens The ability to EXIT the cycle at t his point is to allow t he op erator to retur n to the stan dby state if t he ampoule has not been brok en.
61 OW NER’S MANU AL At the end of the cy cle, the operator opens the door and removes the load. The operator then closes the door and presses the EXIT button.
62 OW NER’S MANU AL Test Vent pump When left button held for 3 seconds Flowchart for Technical and Diagnostic Screens AN74 I ANPROLENE STERILI ZE R START DIAGNOSTICS NO ABATOR DIAGNOSTICS ABATOR ATTACHED PURG V. 0. 0 (>5.00) VENT V. 0.00 (>0.25) BACK P.
63 OW NER’S MANU AL When START pressed AN74 I ANPROLENE STERILI ZE R START SELF TEST VER 4.04 12,000 PUMP HOU RS 94 % FAN RPM Flowchart for Pre-C ycle Error Messages COOLING FAN FAILURE indicates th.
64 OW NER’S MANU AL Press ALARM OFF to stop the alarm Flowchart for V entilation Pump Fail ure During Sterilization Cycle 12 (or 24) HOUR CYCL E STER ILIZ ING 1:24:15 REMAINING STERILIZATION HALTED .
65 OW NER’S MANU AL Count up timer Flowchart for V e ntilation Pump Fa ilure During V e ntilation Cycle 12 (or 24) HOUR CYCLE ST ER IL IZ ING 1:53:15 REMA INI NG VENTILATING BAG 0:20:12 REMAINING UN.
66 OW NER’S MANU AL 12 (or 24) HOUR CYCLE STERILIZING 1:24:15 REMAINING VENTILATING BAG PURGE PUMP FAILURE 24:00:00 REMAINING UNLOAD STERILI ZER 00:00:44 EXI T VENTILATING BAG 0:23:55 REMAINING If a.
67 OW NER’S MANU AL 12 (or 24) HOUR CYCLE STER ILIZ ING 1:24:15 REMAINING VENTILATING BAG 0:00:55 REMAINING UNLOAD STERILIZER 00:00:50 EXI T Starting at the st erilizing screen, the CLOSE DOOR messag e will be displa y ed a nd the alarm will sound if the door is opened at any time before the UNLOAD STERI- LIZER screen.
68 OW NER’S MANU AL APPENDIX F Material Safety Dat a Sheet s © Andersen Products Ltd.
69 OW NER’S MANU AL Product: ANPROLENE® Manufa ctured by: Andersen Ster iliz e rs , Inc. Health Science Park 3154 Carolin e Drive Haw River, NC 27258 USA Inform atio n Teleph on e Nu mbe r: (336) 3.
70 OW NER’S MANU AL SKIN CONTACT: Prolonged con tact with l iquid ethylen e oxide can cause a lo cal er y thema, ede ma, and f or m atio n of blis t e rs . Response is more se vere on da mp skin. There may be a la tency perio d of several hours prior to the onset o f symptoms.
71 OW NER’S MANU AL to diffus e out of th e gas rel ea s e bag and in to the ro om. At one full minute afte r acti vation there is less than 1 ppm measure d at a dis- tance of 18 inches from the gas release bag.
72 OW NER’S MANU AL Various mammali an species expo sed to lethal conc entrations o f ethylen e ox id e had sym p t oms of mucous m embra ne irrit a tion, cent ral nervous system depression, lacrimation, nasal di scharge, sali vation, nausea, vomiting, diarrhea, re spiratory i rritation, incoor din ation, and convulsi ons.
73 OW NER’S MANU AL Section III– Permiss ible Exposure Section V - Fire and Explosion Hazard Data OSHA- Occupa tional Safe ty a nd H ealth Admini stra tion p/p- parts per part PEL- P ermissible ex posure Limit PVC- Polyviny l chlo rid e ppm- Parts pe r million p.
74 OW NER’S MANU AL APPENDIX G AN74 i/ix Specifications © Andersen Products Ltd.
75 OW NER’S MANU AL 1 2 3 4 56 A B C D 6 5 4 3 2 1 D C B A Title Number Revision Size B Date: 14-O ct-2002 Sheet of File: G :ENGINEE RING AN74_ISch_PC BAI SUC.DD B Drawn By: FUSE 2A PLUG 115VAC BAG CABINET AN74 i SYSTEM SCHEM ATIC AISUC 1 L. Le e Print: Design:3-OC T-2002 MOMENTARY PUSHBUTTONS 0.
76 OW NER’S MANU AL 1 2 3 4 56 A B C D 6 5 4 3 2 1 D C B A Title Number Revision Size B Date: 14-Oc t-2002 Sheet of File: G:ENGIN EERINGAN 74_ISch_PCBAI CUE.
77 OW NER’S MANU AL APPENDIX H Equipment Ratings Summary and Replacement Parts List © Andersen Products Ltd.
78 OW NER’S MANU AL APPENDIX G Equipment Ratings Summary Equipment Rating Model Ref . Voltage Hz. Power Fuse Rating AN74.67 AN74 i 115v +/- 10% 50/60 150 Watts 2 Amp. AN74.68 AN74 i 230v +/- 10% 50/60 150 Watts 2 Amp. AN74.69 AN74 i 100v +/- 10% 50/60 150 Watts 2 Amp.
79 OW NER’S MANU AL Anprolene Sterilizers Replacement Parts List This list relates to Models: AN74 i Model: AN 74.67 AN74 ix Model: AN74.87 AN74 i Model: AN 74.68 AN74 ix Model: AN74.88 AN74 i Model: AN 74.69 AN74 ix Model: AN74.89 Part No.: Description AN100.
80 OW NER’S MANU AL APPENDIX I Andersen One Y ear Limited W arranty © Andersen Products Ltd.
81 OW NER’S MANU AL ANDERSEN One-Year Li mited Warr anty Andersen Products, Inc. (“Andersen”) warrants that this Anpr olene© Ste rilizer (“Product”) is free from defects in mate- rial and workmanship that result in Product failure during normal usage, acc ording to the following terms and condi- tions: 1.
82 OW NER’S MANU AL 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 c onditions of this limited warr.
83 OW NER’S MANU AL APPENDIX J 10 Y ear Useful Life of S terilizer © Andersen Products Ltd.
84 OW NER’S MANU AL APPENDIX J 10 Year Useful Life J.1.1 The Useful Li fe of the Andersen AN74i and AN74iX sterilizers is ten (10) years from the date of manufacture. The Lot/Serial Number on the back of the sterilizer indicates the year the sterilizer was manufactured.
85 OW NER’S MANU AL Distributed by : Andersen Products Ltd. Davy Road Gorse Lane Industrial Estate Clacton-on-Sea Essex, CO14 5XA United Kingdom Tel: +44 (0)1255 428 328 E-mail: info@anderseneurope .com Web: www.anderseneurope.com Manufactured by: Andersen Products, Inc.
Un point important après l'achat de l'appareil (ou même avant l'achat) est de lire le manuel d'utilisation. Nous devons le faire pour quelques raisons simples:
Si vous n'avez pas encore acheté Andersen Sterilizers AN74I c'est un bon moment pour vous familiariser avec les données de base sur le produit. Consulter d'abord les pages initiales du manuel d'utilisation, que vous trouverez ci-dessus. Vous devriez y trouver les données techniques les plus importants du Andersen Sterilizers AN74I - de cette manière, vous pouvez vérifier si l'équipement répond à vos besoins. Explorant les pages suivantes du manuel d'utilisation Andersen Sterilizers AN74I, vous apprendrez toutes les caractéristiques du produit et des informations sur son fonctionnement. Les informations sur le Andersen Sterilizers AN74I va certainement vous aider à prendre une décision concernant l'achat.
Dans une situation où vous avez déjà le Andersen Sterilizers AN74I, mais vous avez pas encore lu le manuel d'utilisation, vous devez le faire pour les raisons décrites ci-dessus,. Vous saurez alors si vous avez correctement utilisé les fonctions disponibles, et si vous avez commis des erreurs qui peuvent réduire la durée de vie du Andersen Sterilizers AN74I.
Cependant, l'un des rôles les plus importants pour l'utilisateur joués par les manuels d'utilisateur est d'aider à résoudre les problèmes concernant le Andersen Sterilizers AN74I. Presque toujours, vous y trouverez Troubleshooting, soit les pannes et les défaillances les plus fréquentes de l'apparei Andersen Sterilizers AN74I ainsi que les instructions sur la façon de les résoudre. Même si vous ne parvenez pas à résoudre le problème, le manuel d‘utilisation va vous montrer le chemin d'une nouvelle procédure – le contact avec le centre de service à la clientèle ou le service le plus proche.
