MAINTENANCE MANUAL Amsco Century Medium Steam Sterilizers 26" x 37.5" (660 x 950 mm) Prevacuum SFPP (05/10/02) P

Transcription

1 MAINTENANCE MANUAL Amsco Century Medium Steam Sterilizers 26" x 37.5" (660 x 950 mm) Prevacuum SFPP (05/10/02) P-

2 A Word From STERIS Corporation ADVISORY The operation and maintenance procedures recommended by STERIS are described in this manual. Only these recommended maintenance procedures should be followed. A listing of the safety precautions to be observed when operating and servicing this equipment can be found in Section 1 of this manual. Do not operate or service this equipment until you have become familiar with this information. Any alteration of this equipment not authorized or performed by STERIS Engineering Service which could affect its operation will void the warranty, could adversely affect sterilization efficacy, could violate federal, state, and local regulations, and could jeopardize your insurance coverage. INDICATIONS FOR USE The Amsco Century Medium Steam Sterilizer is designed for sterilization of heat- and moisturestabile materials used in healthcare facilities and is available in two medium size models: Prevacuum designed for sterilization of heat and moisture-stabile materials. The Prevacuum sterilizer is equipped with Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. Steam Flush Pressure Pulse (SFPP) designed for sterilization of heat and moisture-stabile materials. The SFPP sterilizer is equipped with SFPP, WRAP/SFPP, Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick) cycles. This sterilizer is specifically designed to only process goods using the cycles as specified in this manual. If there is any doubt about a specific material or product, contact the manufacturer of that product for the recommended sterilization technique. 2002, STERIS Corporation All rights reserved. Printed in U.S.A. i

3 Factory-Set Cycles and Cycle Values Table 1A. Prevacuum Sterilizer Cycles and Cycle Values Cycles: Sterilize Sterilize Dry Recommended Validation Temp. Time Time Load Standard 1. PREVAC 270 F (132 C) 4 MIN. 5 MIN. Single Fabric Pack ST-8 2. PREVAC 270 F (132 C) 4 MIN. 20 MIN. Double-wrapped instrument trays, max. ST-8 weight of 17 lbs (7.7 kg) each. Fabric packs. Refer to Table 3-2 for recommended quantities. 3. GRAVITY 250 F (121 C) 30 MIN. 15 MIN. Fabric packs. ST-8 Refer to Table 3-2 for recommended quantities. 4. LIQUID 250 F (121 C) 45 MIN. 0 MIN. Refer to Table 3-3 for guidelines. ST-8 Table 1B. Steam Flush Pressure-Pulse Sterilizer Cycles and Cycle Values Cycles: Sterilize Sterilize Dry Recommended Validation Temp. Time Time Load Standard 1. WRAP/ 270 F (132 C) 4 MIN. 20 MIN. Double-wrapped instrument trays, max. wt.: ST-8 SFPP 17 lbs (7.7 kg) each. Non-porous Goods, only. Refer to Table 3-2 for recommended quantities. 2. SFPP 270 F (132 C) 4 MIN. 20 MIN. Fabric Packs ST-8 Refer to Table 3-2 for recommended quantities. 3. PREVAC 270 F (132 C) 4 MIN. 20 MIN. Double-wrapped instrument trays, max. wt.: ST-8 17 lbs (7.7 kg) each. Fabric Packs. Refer to Table 3-2 for recommended quantities. 4. GRAVITY 250 F (121 C) 30 MIN. 15 MIN. Fabric packs. ST-8 Refer to Table 3-2 for recommended quantities. Test Cycles Sterilize Sterilize Dry Recommended Validation for All Units Temp. Time Time Load Standard 5. Leak Test F (132 C) N/A N/A N/A ST-8 6. DART Test F (132 C) 3-1/2 MIN. 1 MIN. DARTor Bowie-Dick ST-8 Test Pack 7. DART Warm-up F (132 C) 3 MIN. 1 MIN. N/A N/A 1 Not adjustable. ii

4 Recommended Loads by Sterilizer Size 1 Wrapped Fabric Instrument Trays Packs 26 x 37.5 x 36" (660 x 950 x 910) x 37.5 x 48" (660 x 950 x 1220) x 37.5 x 60" (660 x 950 x 1520) Refer to Tables 1A and 1B to determine cycle use guidelines. Liquid Cycle Processing Guidelines Minimum Recommended Number of Volume of Liquid Sterilize Time at 250 F (121 C) Containers in One Container in minutes ml 45 Prevacuum Sterilizer Menu Screen Steam Flush Pressure Pulse Sterilizer Menu Screen TEMP F 1 PRESS psig STATUS... DOOR OPEN PREVAC PREVAC GRAVITY LIQUID 270 F 270 F 250 F 250 F S= 4:00 S= 4:00 S= 30:00 S= 45:00 D= 5:00 D= 20:00 D= 15:00 D= 00:00 Cycle Selection Touch Pads TEMP F 1 PRESS psig STATUS... DOOR OPEN WRAP/SFPP SFPP PREVAC GRAVITY 270 F 270 F 270 F 250 F S= 4:00 S= 4:00 S= 4:00 S= 30:00 D= 20:00 D= 20:00 D= 20:00 D= 15:00 00:00:00 AM 00/00/00 PAPER MORE MENU FEED CYCLES STANDBY 00:00:00 AM 00/00/00 PAPER MORE MENU FEED CYCLES STANDBY iii

5 0123 EC Authorized Representative STERIS Ltd. STERIS House Jays Close Viables Basingstoke Hampshire RG22 4AX UNITED KINGDOM Tel: +44 (0) Fax: +44 (0) Manufactured by: STERIS Corporation 2424 West 23rd Street Erie, PA USA Tel: Fax: STERIS Offices Worldwide Canada Germany Italy Japan Korea Latin America Singapore Spain United Kingdom Manufactured Exclusively by STERIS Corporation Erie, PA ISO 9001 EN ISO Certified The base language of this document is ENGLISH. Any translations must be made from the base language document. STERIS Corporation 5960 Heisley Road Mentor, OH USA iv

6 Table of Contents Section Title Page Section 1: Listing of Warnings and Cautions Section 2: General Information GENERAL DESCRIPTION TECHNICAL SPECIFICATIONS Section 3: Operating Instructions BEFORE OPERATING THE STERILIZER PREPARING LOADS FOR STERILIZATION CYCLES GUIDELINES FOR PLACEMENT OF VARIOUS LOADS UNLOADING THE STERILIZER LOADING CAR INSTRUCTIONS: LOADING LOADING CAR INSTRUCTIONS: UNLOADING LOADING/UNLOADING STERILIZER: RACK AND SHELVES STERILIZER (FACTORY) CYCLE SETTINGS PREVACUUM STERILIZER CYCLES SFPP STERILIZER CYCLES PREVAC CYCLE 270 F (132 C) GRAVITY CYCLE LIQUID CYCLE WRAP/SFPP CYCLE, 270 F (132 C) SFPP CYCLE, 270 F (132 C) TEST CYCLES DART (Bowie-Dick) Test Vacuum Leak Test ABORTING CYCLES EMERGENCY DOOR OPENING PROCEDURE CYCLE GRAPHS Section 4: Principles of Operation GENERAL MECHANICAL COMPONENT DESCRIPTION CENTURY CONTROL THEORY OF OPERATION MAIN CONTROL A. Incoming Power Terminal Block B. Power Switch C. Line Filter D. Connector Board E. Power Supply (see Figure 4-1) CPU Board A. CPU Chip B. Flash Memory C. Static RAM D. A/D Converter Section E. Battery Back-up CPU Board Setup A. Flash Chip Change B. Jumpers C. LED Display on CPU Board v continued on next page

7 Section Title Page I/O BOARD A. Overview B. I/O Configuration DISPLAY A. Touch Screen B. Display Module C. Display Interface Board D. Printer Board Assembly E. Power Supply F. Speaker G. Printer H. Paper Take Up Mechanism ANALOG DEVICES Pressure Transducer (See Figure 4-6) RTD (See Figure 4-7) CYCLES AND PHASES Prevacuum Cycle A. Jacket Temperature - Out of Cycle B. Activate Seal(s) C. Purge D. Vacuum Pulse E. Pressure Pulse F. Charge G. Sterilize H. Fast Exhaust I. Dry J. Air Break K. Retract Seals L. Complete Gravity Cycle A. Jacket Temperature - Out of Cycle B. Activate Seal(s) C. Purge D. Charge E. Sterilize F. Fast Exhaust G. Dry H. Air Break I. Retract Seals J. Complete SFPP Cycles A. Jacket Temperature - Out of Cycle B. Activate Seal(s) C. Purge D. Exhaust Pulse after Purge E. Steam Flush after Purge F. Pressure Pulse G. Exhaust Pulse H. Pressure Pulse Steam Flush I. Charge J. Sterilize K. Fast Exhaust L. Dry vi continued on next page

8 Section Title Page M. Air Break N. Retract Seals O. Complete Liquid Cycle A. Jacket Temperature - Out of Cycle B. Activate Seal(s) C. Purge D. Charge E. Sterilize F. Slow Exhaust G. Air Break H. Retract Seals I. Cracked Door Phase J. Complete Section 5: Service Mode ACCESS SERVICE MODE Scientific Sterilizers ACCESS SERVICE MODE Healthcare Sterilizers CALIBRATION Calibration Overview Calibrate Temperature A. Steam Method of Calibration A1. Calibrate Chamber Recorder Temperature A2. Calibrate Jacket Temperature A3. Calibrate Waste Temperature B. Oil Bath Method of Calibration C. Load Values Method of Temperature Calibration Pressure Calibration A. Steam Method of Pressure Calibration B. External Method of Pressure Calibration C. Load Values Method of Pressure Calibration Temperature/Pressure Units A. Pressure Units B. Temperature Units Temperature/Pressure Verification Calibration History INPUT/OUTPUT TESTS Safety Valve Tests Door Sensor Adjustments ADJUSTMENTS Door Pressure Settings Leak Test VALVE HISTORY Valve Service View Valve Actuation History View Valve Cycle Count History vii continued on next page

9 Section Title Page 5.7 ALARM MAINTENANCE Alarm List Alarm Log Show Screens Pushbutton Test Battery Saver Configure Machine Set Configurations CHANGE VALUES Section 6: Inspection and Maintenance PREVENTIVE MAINTENANCE SCHEDULE CLEAN CHAMBER DRAIN STRAINER CLEAN CHAMBER FLUSH CHAMBER DRAIN PERFORM WEEKLY CHANGE PRINTER PAPER ROLL Change Printer Ink Cartridge Section 7: Field Test Procedures GENERAL TEST INSTRUMENTATION REQUIRED INSTALLATION DATA INSTALLATION VERIFICATION CONTROL SETUP Loss of Power Test Control Input and Wiring Check Control Output and Wiring Check TEMPERATURE CALIBRATION PRESSURE CALIBRATION DOOR ADJUSTMENT VERIFICATION Hinge Door Hinge Door Adjusting Procedure Sliding Door General Upper Rail Assembly and Adjustment Door Fore/Aft Follower Assemblies Adjustment Door Adjustment and Function Check Door Drive Cable Tension Adjustment Door Open Sensor Adjustment Door Shock Absorber Adjustment Final Door Operation Check SAFETY VALVE TEST AND REGULATOR VALVE SETTING VACUUM PUMP TEST Vacuum Pump Water Flow Rate Vacuum Pump Performance Test LEAK TEST PERFORMANCE TEST viii continued on next page

10 Section Title Page Section 8: Troubleshooting GENERAL Typical Alarm Screen Too Long In Charge Typical Alarm Printout IN-CYCLE ALARMS Too Long In Exhaust Too Long In Evacuation Too Long In Air Break Under Sterilize Temperature Over Sterilize Temperature Door Unsealed Chamber Pressure/Temperature Failure No Pump Water Exhaust Rate Too Fast Exhaust Rate Too Slow Recorder Deviation Alarm Door Pressure Failure (Hinged Door Models Only) OUT-OF-CYCLE ALARMS Too Long To Close Door Too Long To Open Door Pressure In Chamber Waste Temperature Probe Failure Display Error Atmospheric Pressure Alarm Relay #1 Failure Relay #2 Failure Relay #3 Failure RTC Failure ROM Failure RAM Failure ADC Failure SENSOR ALARMS Water In Chamber Too Long In Jacket Charge Too Long To Seal Door Too Long To Unseal Door Chamber Pressure Transducer Failure Chamber Temperature Probe Failure Jacket Temperature Probe Failure Door Switch Failure Recorder Temperature Probe Failure Board Overtemp Failure ix continued on next page

11 Section Title Page Section 9: Component Replacement and Repair AIR FILTER SOLENOID VALVES CHECK VALVES STEAM TRAPS STEAM PRESSURE REGULATING VALVE Disassembly Reassembly SAFETY VALVE STRAINERS HEAT EXCHANGER VACUUM PUMP CPU BOARD FLASH MEMORY CHIPS U13, U16, U15 AND U BATTERY I/O BOARD POWER SUPPLY MAIN CONTROL BOX CONNECTOR BOARD DISPLAY ASSEMBLY PRINTER BOARD ASSEMBLY Section 10: Illustrated Parts Breakdown HOW TO USE THE ILLUSTRATED PARTS BREAKDOWN PREVENTIVE MAINTENANCE PACKS x

12 Section 1: Listing of Warnings and Cautions The following is a listing of safety precautions which must be observed when operating or servicing this equipment. WARNINGS indicate the potential for danger to personnel, and CAUTIONS indicate the potential for damage to equipment. These precautions are repeated (in whole or in part), where applicable, throughout the manual. Observance of these safety precautions will minimize the risk of personal injury and/or the possible use of improper maintenance methods which may damage the unit or render it unsafe. It is important to understand that these precautions are not exhaustive. STERIS could not possibly know, evaluate and advise maintenance departments of all conceivable ways in which maintenance might be done or the possible hazardous consequences of each way. WARNING ELECTRIC SHOCK AND BURN HAZARD: Disconnect all utilities to sterilizer before servicing. Do not service the sterilizer unless all utilities have been properly locked out. Always follow OSHA Lockout-Tagout and electrical safety-related work practice standards. (See CFR and.331 through.335.) WARNING PERSONAL INJURY HAZARD: Avoid personal injury from bursting bottles. Liquid sterilization cycle must only be used for liquids in borosilicate (Pyrex) flasks with vented closures. WARNING: It is inappropriate for a healthcare facility to sterilize liquids for direct patient contact. WARNING BURN HAZARD: When sterilizing liquids, to prevent personal injury or property damage resulting from bursting bottles and hot fluid, you must observe the following procedures: Use Liquid cycle only; no other cycle is safe for processing liquids. Use only vented closures; do not use screw caps or rubber stoppers with crimped seal. Use only Type I borosilicate glass bottles; do not use ordinary glass bottles or any container not designed for sterilization. Do not allow hot bottles to be jolted; this can cause hot-bottle explosions. Do not move bottles if any boiling or bubbling is present. Sterilizer, rack/shelves, and loading car will be hot after cycle is run. Always wear protective gloves and apron when removing a processed load. Protective gloves and apron must be worn when reloading sterilizer following the previous operation. Do not attempt to open the sterilizer door if a WATER IN CHAMBER ALARM condition exists. Call a qualified service technician before attempting to use sterilizer further. 1-1

13 WARNING BURN HAZARD: (CONTINUED) After manual exhaust, steam may remain inside the chamber. Always wear protective gloves, apron, and a face shield when following emergency procedure to unload sterilizer. Stay as far back from the chamber opening as possible when opening the door. For Prevauum, Gravity or SFPP cycles, if 0 (zero) dry time is selected, steam vapors will be released when opening door. Step back away from the door when opening door. Door should only be opened 2-3 inches (50-75 mm) until no more vapors are seen, before opening the door fully. Allow sterilizer to cool to room temperature before performing any cleaning or maintenance procedures. Failure to shut off the steam supply when cleaning or replacing strainers can result in serious injury. Jacket pressure must be 0 psig (0 bar) before beginning work on the steam trap. Proper testing of the safety valve requires the valve to be operated under pressure. Exhaust from the safety valve is hot and can cause burns. Proper safety attire (gloves, eye protection, insulated overall) as designated by OSHA, is required. Testing is to be performed by qualified service personnel only. WARNING EXPLOSION HAZARD: This sterilizer is not designed to process flammable compounds. WARNING FALL HAZARD: To prevent falls, keep floors dry by immediately wiping up any spilled liquids or condensation in sterilizer loading or unloading area. WARNING PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment. Contact your STERIS service representative to schedule preventive maintenance. When closing the chamber door, keep hands and arms out of the door opening and make sure opening is clear of obstructions. Repairs and adjustments to this equipment must be made only by fully qualified service personnel. Maintenance performed by inexperienced, unqualified persons or installation of unauthorized parts could cause personal injury or result in costly equipment damage. WARNING STERILITY ASSURANCE HAZARD: Load sterility may be compromised if the biological indicator or air leak test indicates a potential problem. If these indicators show a potential problem, refer the situation to a qualified service technician before using the sterilizer further. According to AAMI standards, a measured leak rate greater than 1 mm Hg/minute (1.3 mbar/min) indicates a problem with the sterilizer. Refer the situation to a qualified service technician before using the sterilizer further. 1-2

14 CAUTION POSSIBLE EQUIPMENT DAMAGE: Gasket must be fully retracted prior to operating sterilizer door. Never use a wire brush, abrasives, or steel wool on door and chamber assembly. Do not use cleaners containing chloride on stainless-steel surfaces. Chloride-based cleaners will deteriorate stainless steel, eventually leading to failure of the vessel. Allow thermostatic traps to cool down to room temperature before removing cover. Since there is nothing to limit expansion, the bellows may rupture or fatigue if trap is opened while hot. Actuation at less than 75% of rated pressure can allow debris to contaminate the seat and cause the safety valve to leak. A leaking safety valve must be replaced. Insufficient service clearance will make repairs more difficult and time-consuming. Piping sizing too small may cause water hammer, resulting in damage to the sterilizer. After installation, it is mandatory to brace piping at the drain funnel so that it will not move vertically. Make sure door opening is clear of any obstruction before closing the door(s). Do not attempt to open sterilizer door during manual operation unless chamber is at 0 psig. During manual operation, gasket must be fully retracted prior to operating sterilizer door. Immediately wipe up saline solution spills on loading car, to prevent damage to stainless steel. Do not use cleaners containing chlorides on loading cars. Chloride-based cleaners will deteriorate the loading car metal. Sterilization of chloride-containing solutions (e.g., saline) can cause chamber corrosion and is not recommended by the manufacturer. If, however, chloride-containing solutions must be processed, clean the chamber after each use. 1-3

15 Section 2: General Information The product literature included in this section contains factual data relating to the principal characteristics of the Amsco Century Medium Steam Sterilizers. The literature is informative rather than instructional. It provides and conveys, through text and illustrations, a general concept of the equipment, its purpose, limitations, and technical applications. 2.1 GENERAL DESCRIPTION The Amsco Century Medium Steam Sterilizers are used to sterilize heat- and moisture stable goods in Healthcare of industrial facilities. 2.2 TECHNICAL SPECIFICATIONS Overall Exterior Dimensions W x L x H 36" Sterilizer: Hinged Door 44 x 51-1/2 x 75-1/4" (1118 x 1308 x 1911 mm) Sliding Door 70 x 57 x 75-1/4" (1778 x 1448 x 1911 mm) 48" Sterilizer: Hinged Door 44 x 63-1/2 x 75-1/4" (1118 x 1600 x 1911 mm) Sliding Door 70 x 69 x 75-1/4" (1778 x 1753 x 1911 mm) 60" Sterilizer: Hinged Door 44 x 75-1/2 x 75-1/4" (1118 x 1918 x 1911 mm) Sliding Door 70 x 81 x 75-1/4" (1778 x 2057 x 1911 mm) Weight (Fully Loaded) 36" Sterilizer: 3800 lbs (1720 kg) 48" Sterilizer: 4200 lbs (1901 kg) 60" Sterilizer: 4700 lbs (2127 kg) Utility Requirements Electric: Controls: 120V, 2A, 1-phase Vacuum Pump: 208/240 V, 6A, 3-phase, or 480 V, 3A, 3- phase Water: Pressure: 20 to 50 psig (1.4 to 3.5 bar) Temperature: 70 F (21 C) maximum Consumption: 15 gpm (57 lpm), peak Steam: Pressure: 50 to 80 psig (3.5 to 5.2 bar) Consumption: 36" Sterilizer: 190 lb/hr (86 kg/hr) 48" Sterilizer: 255 lb/hr (116 kg/hr) 60" Sterilizer: 335 lb/hr (152 kg/hr) See Tech Datas in this section. 2-1

16 AMSCO CENTURY TM MEDIUM STEAM STERILIZER 26" X 37.5" NORTH AMERICA APPLICATION Two configurations are available for sterilization of heat- and moisturestable materials used in healthcare facilities: Prevacuum designed for fast, efficient sterilization of heat- and moisture-stable materials. Prevacuum configuration sterilizers are equipped with prevacuum, gravity, liquid, leak test, and daily air removal (Bowie-Dick) test cycles. Steam Flush Pressure Pulse (SFPP) designed for fast, efficient sterilization of heat- and moisturestable materials. This configuration sterilizer uses the Steam Flush Pressure Pulse cycle, which features an above-atmospheric pressure level conditioning phase. SFPP sterilizers are equipped with SFPP, WRAP/ SFPP, prevacuum, gravity, liquid, leak test, and daily air removal (Bowie-Dick) test cycles. DESCRIPTION Amsco Century Medium Steam Sterilizers are equipped with the latest features in both state-of-the-art technology and ease of use. Hinged Door Model Primary Product Features Interior Chamber Dimensions 26 x 37.5 x 36" (660 x 950 x 910 mm) 26 x 37.5 x 48" (660 x 950 x 1220 mm) 26 x 37.5 x 60" (660 x 950 x 1520 mm) 48" and 60" configurations include choice of a single or double door; 36" configuration provides single door, only. (Typical only - some details may vary.) Horizontal-sliding Door Model Hinged door with fast operating, loweffort door lock mechanism. Door handle lock lever requires a single 30 handle movement to lock or unlock. Horizontal-sliding door with quiet, motor-driven cable and pulley mechanism. Door travels horizontally right to left to open, and is controlled from the touch screen. The Selections Checked Below Apply To This Equipment TYPE Prevacuum Steam Flush Pressure Pulse (SFPP) SIZE 26 x 37.5 x 36" (660 x 950 x 910 mm) (single door only) 26 x 37.5 x 48" (660 x 950 x 1220 mm) 26 x 37.5 x 60" (660 x 950 x 1520 mm) STEAM SOURCE Building Steam VACUUM PUMP ELECTRIC SERVICE 208/240 VAC, 60 hz, 3-Phase, 6A per phase 480 VAC, 60 hz, 3-Phase, 3A per phase DOOR CONFIGURATION Single-door Hinged Horizontal-sliding Select direction of door swing or slide to open, as viewed from Sterilizer's Operating End: Left-hand Right-hand (not available for slidingdoor units) Double-door* Hinged Door NOTE: Operating End hinge position listed first; Non-operating End hinge listed second. Right-hand/Left-hand Right-hand/Right-hand Left-hand/Right-hand Left-hand/Left-hand Horizontal-sliding Door NOTE: Operating End slide direction listed first; Non-operating End slide direction listed second. Left-hand/Right-hand SINGLE-DOOR MOUNTING Cabinet Enclosed/Freestanding Recessed DOUBLE-DOOR MOUNTING Recessed through One Wall Recessed through Two Walls * 26 x 37.5 x 36" sterilizers not available in double-door configuration. ACCESSORIES 36" (910 mm) Chamber Length 48" (1220 mm) Chamber Length 60" (1520 mm) Chamber Length Loading Car Transfer Carriage Chamber Track Assembly Single Door Double Door Loading Car, Transfer Carriage, and Track Assembly Single Door Double Door (36" Units, only) Chamber Rack and Shelf Seismic Tie-down Kit Item Location(s) SD724 (02/01/02)

17 Century control system with enhanced functionality and user-friendly interface screen. Touch-sensitive screen with 30-line x 40-character display area Ink-on-paper impact printer Help screens for programming and troubleshooting alarm conditions Automatic check of control program and cycle data maintains process integrity. Vacuum pump is supplied on all units to effectively pull chamber to specified vacuum levels, as well as reduce water consumption. STANDARDS Each sterilizer meets applicable requirements of the following listings and standards, and carries the appropriate symbols: Underwriters Laboratory (UL) Standard 3101 as certified by ETL Testing Laboratories, Inc. Canadian Standards Association (CSA) Standard C22.2, No ASME Code, Section VIII, Division 1 for unfired pressure vessels. The pressure vessel is so stamped; ASME Form U-1 is furnished. Shell and door are constructed to withstand working pressure of 45 psig (3.1 bar). FEATURES 26 x 37.5" chamber cross-section is sized to allow for efficient, high-volume processing of sterilization. Fast-operating, low-effort manual door lock mechanism (hinged-door models) allows door to be locked or unlocked using a single 30 handle motion. Horizontal-sliding Power Door is controlled from the touch screen display. The door slides horizontally on a rigid rail assembly housed within stainless-steel paneling. Door drive system consists of a cable and pulley arrangement driven by an electric motor. Resistive Thermal Detectors (RTD) are installed for sterilizer temperature control. The dual element chamber drain line RTD senses and controls temperature variations within the sterilizer chamber. A jacket RTD provides temperature control within the jacket space. These RTD signals, converted into electrical impulses, provide accurate control inputs and readouts throughout entire cycle. Electronic water saving control includes an RTD to control the amount of water used in condensing the exhausted chamber steam. Software calibration is performed in the service mode, accessible through the touch screen displays, and accomplished using external or internal temperature and pressure sources. Control system provides printed record of all calibration data for verification to current readings. Automatic utilities start-up/shutdown permits utilities conservation. Shutdown may be programmed to activate at the end of any designated cycle or time of day. When activated, control system automatically shuts off all utility valves, conserving steam and water usage. Sterilizer utilities can be restarted either by programmed time or manual operation. A different shutdown and restart time can be programmed for each day. Steam purge feature is provided to assist in air removal and to preheat the load. Two-piece insulation sleeve is fitted around exterior of the sterilizer vessel. The sleeve is sealed and held in place by hook-and-loop closures. Insulation is asbestos-free and chloride-free, silicone impregnated, oil- and waterresistant fiberglass. Lighted DIN connectors are installed on all steam, water, and exhaust valves for reliability and ease of maintenance. PROCESSING CYCLES All processing cycles factory programmed into the sterilizer control have been validated to AAMI ST8. Prevacuum configuration sterilizers are factory programmed with the following cycles: Prevacuum (with either 5-minute or 20-minute dry phases), Gravity, Liquid, and Test Cycles. SFPP configuration sterilizers are factory programmed with the following cycles: Wrap/SFPP, SFPP, Prevacuum, Gravity, Liquid, and Test Cycles. See cycle descriptions below for more details: Prevacuum Cycle: For efficient, high-volume processing of heat- and moisture-stable materials, such as fabrics and wrapped hard goods. This process incorporates a series of pressure/vacuum pulses to condition the load prior to sterilization.» Sterilize temperature: 270 F (132 C)» Sterilize time: 4 minutes» Dry time: 5 minutes or 20 minutes 250 F Gravity Cycle: For sterilizing fabrics.» Sterilize temperature: 250 F (121 C)» Sterilize time: 30 minutes» Dry time: 15 minutes NOTE: A Gravity Cycle, adjusted to 270 F for 25-minute sterilize exposure time, can be used for processing fabric packs. 270 F Gravity Cycle: For sterilizing hard goods.» Sterilize temperature: 270 F (132 C)» Sterilize time: 15 minutes» Dry time: 30 minutes NOTE: 270 F temperature must be set by user. SFPP Cycle: For efficient, highvolume processing of porous loads. Process incorporates a series of steam flushes and pressure pulses at pressures above atmospheric 2

18 levels to condition load prior to sterilization.» Sterilize temperature: 270 F (132 C)» Sterilize time: 4 minutes» Dry time: 20 minutes Wrap/SFPP Cycle: For efficient, high-volume processing of heatand moisture-stable materials, such as double-wrapped instrument trays. This process incorporates a series of steam flushes and pressure pulses at pressures above atmospheric levels to condition load prior to sterilization.» Sterilize temperature: 270 F (132 C)» Sterilize time: 4 minutes» Dry time: 20 minutes Liquid Cycle: This cycle is used for sterilizing liquids in borosilicate containers with vented closures.» Sterilize temperature: 250 F (121 C)» Factory programmed sterilize time: 45 minutes» Dry time: not applicable IMPORTANT: It is inappropriate for a healthcare facility to sterilize liquids for direct contact with patients. TESTING CYCLES Vacuum Leak Test: This cycle is used for testing the vacuum integrity of the sterilizer s piping. Sterilizer chamber must be empty while running this test cycle. Preprogrammed cycle parameters cannot be adjusted by the user. DART (Bowie-Dick) Test Cycle: This cycle is used to conduct a Bowie-Dick test on the sterilizer. Recommended load is a STERIS Dart pack, or a properly prepared Prevac Configuration Sterilizer TEMP F 1 PRESS PSIG STATUS... DOOR OPEN PREVAC PREVAC GRAVITY LIQUID 270 F 270 F 250 F 250 F S= 4:00 S= 4:00 S= 30:00 S= 45:00 D= 5:00 D= 20:00 D= 15:00 D= 00:0 00:00 AM ABORT PAPER MENU MORE FEED CYCLES STANDBY SFPP Configuration Sterilizer TEMP F 1 PRESS PSIG STATUS... DOOR OPEN WRAP/SFPP SFPP PREVAC GRAVITY 270 F 270 F 270 F 250 F S= 4:00 S= 4:00 S= 4:00 S= 30:00 D= 20:00 D= 20:00 D= 20:00 D= 15:00 00:00 AM ABORT STATUS PAPER MORE MENU PRINT STANDBY FEED CYCLES Typical Touch Screen Displays Bowie-Dick test pack. Preprogrammed cycle parameters cannot be adjusted by the user.» Sterilize temperature: 270 F (132 C)» Sterilize time: 3.5 minutes» Dry time: 1 minute CONTROL SYSTEM Design Features Century control system monitors and controls all sterilizer operations and functions. The control system is factory-programmed with standard sterilizing cycles. All operator-accessible control functions can be changed using the touch screen control. IMPORTANT: If factory-programmed cycle values are changed, it is the responsibility of the healthcare facility to validate the efficacy of the changed cycle. Cycle values and operating features may be adjusted and verified prior to cycle operation. Cycle parameters are retained in control memory for repeated use. Once cycle is started, cycles and cycle values cannot be changed until cycle is complete. If chamber temperature drops below set point during the exposure phase, the timer is set to stop and automatically reset once normal operating temperature is reached. Critical control system components are housed within a sealed compartment to protect the components from moisture and heat generated during the sterilization process. A cooling fan with filter is installed in the housing compartment to maintain positive pressure within the compartment, keeping components cool and dustfree. Operator interface control panel, consisting of a touch screen and impact printer, is located on the operating (i.e., load or non-sterile) end of the sterilizer. If sterilizer is equipped with double doors, an additional touch screen is provided on the sterilizer's non-operating (i.e., unload or sterile) end. Touch-sensitive Screen features a 30-line x 40-character graphics display. All sterilizer functions, including cycle initiation and cycle configuration, are operated by pressing the touch-sensitive areas on the display, referred to as "touch pads." Display indicates appropriate control buttons, operator prompts, and status messages necessary to assist in sterilizer operation. All displayed messages are complete phrases with no codes to be crossreferenced. Display also indicates any abnormal conditions that may exist either in or out of a cycle. Ink-on-paper Impact Printer, located above touch screen, provides an easy-to-read printed record of all pertinent cycle data on 2 1 /4" wide paper. Data is automati- 3

19 cally printed at the beginning and end of each cycle and at transition points during the cycle. Printer take-up spool stores an entire roll of paper, providing cycle records which can be saved for future reference. Three paper tape rolls and two printer ribbons are furnished with each unit. Non-Operating End (NOE) Control Panel, equipped on double-door sterilizers only, includes a touchsensitive screen similar to the operating end screen. Preprogrammed cycles can be started from the NOE control panel. Display concurrently shows the same information as the operating end screen display. Cycle Configuration is performed by accessing the change values menu through the operating end touch screen. In addition to adjustment of cycle values, the following operating parameters can also be changed through the change values menu: Time Display and Printout Units AM/PM or 24-hour notation. Access Code requires entry of a four-digit access code to operate the sterilizer and/or change the cycle values. Operating the sterilizer or accessing Change Values menu causes display to request the entry of an access code. If access code is not properly entered, display returns to the standby or main menu screen, denying user access to the sterilizer or programming. Audible Signals are adjustable. Touch Pad and end-of-cycle signals can be adjusted to one of four sound levels (off, low, medium, or high) as required for the operating environment. Alarm signal can be adjusted to low, medium, or high (it cannot be turned off). Print Format allows selection of either a full or condensed printout of the cycle information during processing. Temperature Display and Printout Units Fahrenheit ( F) or Celsius ( C). Temperature is set, displayed, controlled, and printed to the nearest 1. Recalibration is not required when changing temperature units. Pressure/Vacuum Display and Printout Units psig/in Hg or bar. Recalibration is not required when changing pressure units. Technical Data Control system consists of microcomputer control boards and peripheral function circuit boards, located within the control PC board housing. An internal battery backs up all cycle memory for up to 10 years. If a power failure occurs during a cycle, the battery backup system assures that cycle memory will be retained and proper cycle completion will occur once power is restored. When power is lost, the cycle is held in phase until power is restored, exceeding the minimum government specification of 1 minute. Once power returns, the event is recorded on the printout and the cycle automatically resumes or restarts, depending on what phase the cycle was in at the time of power loss. If necessary, the operator can manually abort the cycle. SAFETY FEATURES Control lockout switch equipped on chamber door, senses when door seal is energized and tight against the door. Control prevents cycle from starting until the limit switch signal is received. If control loses appropriate signal during cycle, alarm activates, cycle aborts, and chamber safely vents with a controlled exhaust. Chamber float switch activates alarm, aborts cycle, and safely vents chamber with a controlled exhaust if excessive condensate is detected in the vessel chamber. Pressure relief valve limits the amount of pressure buildup so that the rated pressure in the vessel is not exceeded. Power door safety feature causes door drive to slip if the sliding door encounters an obstruction during its movement. 4 CONSTRUCTION Shell Assembly Two fabricated Type 316L stainlesssteel shells, welded one within the other, form the sterilizer vessel. Type 316L stainless-steel end frame(s) is welded to door end. On single door units, back of chamber is fitted with welded, 316L stainless-steel dished head. Sterilizer vessel is ASME rated at 45 psig (3.1 bar) and insulated. Vessel includes one 1"-NPT chamber port for customer use. Steam-supply opening inside the chamber is shielded by a stainlesssteel baffle. Chamber Door(s) Door is constructed of Type 316L stainless steel. During cycle operation, door is sealed by a steam-activated door seal. Door seal is constructed of a special longlife rubber compound. When sterilize cycle is complete, the seal retracts under vacuum into a machined groove in the sterilizer's end frame. A long-life proximity switch is used by the control to determine if door is closed or locking plates are engaged. An additional seal pressure switch prevents inadvertent cycle initiation if door is not sealed. The door assembly is equipped with a mechanical locking mechanism that ensures the door cannot be opened as long as the seal is intact and energized and more than 2 psi (0.14 bar) pressure is in the chamber. The sterilizer door is fitted with a stainless-steel panel that insulates the operator from the chamber end frame, reducing the chance of accidental contact with a hot metal surface.

20 Chamber Drain System Drain system is designed to prevent sterilizer effluent from entering into the water-supply system and sterilizer. The automatic condensing system, consisting of a stainless-steel plate-type condenser, converts chamber steam to condensate and disposes condensate to waste. Cooling water flow is regulated by the waste line RTD to minimize water usage. Water supply shut off valve is located in the recessed area of the unit. Vacuum System Vacuum pump reduces chamber pressure during prevacuum and postdrying phases. Air is drawn from chamber through the vacuum system. Following dry phase, chamber vacuum is relieved to atmospheric pressure by admitting air through a bacteriaretentive filter. Steam Source Sterilizers are piped, valved, and trapped to receive building-supplied steam delivered at 50 to 80 psig (3.5 to 5.6 bar) dynamic. Steam piping is constructed of brass and includes a shut-off valve, steam strainer, and a pressure regulator. Piping All piping connections terminate within the confines of the sterilizer and are accessible from front and left side of sterilizer. Solenoid Valves with DIN connectors simplify sterilizer piping and can be serviced individually. Manual Shut-off Valves are pressure rated at 125 psig (8.62 bar) for saturated steam. Valve handles are low-heat conducting. MOUNTING ARRANGEMENT Sterilizers are arranged for either freestanding or recessed installation, as specified. Each sterilizer is heightadjustable. Sterilizer subframe is equipped with a synthetic rubber gasket to support a tight fit between the cabinet panels on freestanding units or between the front cabinet panel and wall partition on recessed units. On freestanding units, stainless-steel side panels and a louvered top panel enclose the sterilizer body and piping. ACCESSORY Seismic Tie-down Kit conforms to Title 24 California Code of Regulations, 1993 Amendment Section 2336(B). Material Handling Accessories include stainless-steel chamber tracks and stainless-steel loading cars with painted-steel carriages. Stainless-steel chamber rack and shelf are available for 36" (914 mm) sterilizers. See separate product literature for details. PREVENTIVE MAINTENANCE A global network of skilled service specialists can provide periodic inspections, and adjustments to assure low-cost peak performance. STERIS representatives can provide information regarding Annual Maintenance Agreements. NOTES 1. The sterilizer is not supplied with a vacuum breaker or back-flow prevention device and, where required by local codes, installation of such a device in water line is by others. 2. Pipe sizes shown indicate terminal outlets only. Building service lines, provided by others, must supply the specified pressures and flow rates. 3. Disconnect switches (with OFF position lockout only; by others) should be installed in electric supply lines near the equipment. 4. Access to the recessing area from the control end of the sterilizer is recommended. 5. Clearances shown are minimal for installing and servicing the equipment. 6. Depending on the loading equipment used, additional clearance is required: 5 If shelves are used, length of sterilizer plus 24" (610 mm) at each door. If loading car and carriage will be used, twice the length of sterilizer at each door. 7. Floor drain should be provided within confines of sterilizer framework. 8. Units require minimum 38" (966 mm) door opening for transport within facility prior to installation. UTILITY REQUIREMENTS Steam (S) 1" NPT, 50 to 80 psig (3.5 to 5.6 bar) dynamic, 97 percent to 100 percent vapor quality. Drain (D) 2" ODT drain terminal. (Floor drain capacity must handle peak water consumption; refer to Engineering Data.) Electrical Controls (EC) 120 Volt, 50/60 Hz, 1-phase, 2.0 A. Electrical Vacuum Pump (VP) 208/240 Volt, 50/60 Hz, 3-phase, 6 A per phase. 480 Volt, 50/60 Hz, 3-phase, 3 A per phase. Sterilizer Feed Water (FW) 1" NPT, 20 to 50 psig (2.1 to 3.5 bar) dynamic. Water is used for vacuum pump, heat exchanger, and trap cooling. Refer to Water Quality Recommendations listed on page 7. NOTE: Back-flow prevention is by others; not supplied on unit.... CHECK LOCAL CODES...

21 ON OFF POWER ON OFF POWER Single Hinged-Door, Cabinet Enclosed Single Hinged-Door, Recessed, One Wall D D 38 1 (965) 53.5 (1359) 36 2 (914) 38 1 (965) 36 2 (914) 47 1 (1194) FW VP EC S 44 (1118) 36 2 (914) 47 1 (1194) FW VP EC S 38 3 (965) 44 (1118) 36 2 (914) B 30 2 (762) 4-8 ( ) Wall Thickness A 30 2 (762) 4-8 ( ) Wall Thickness 75.25, Typical (1911) , Typical (1911) 75.25, Typical (1911) 1 Service Clearance 2 Door Swing (left hand swing shown) 3 Wall Opening Dimensions are inches (millimeters). ENGINEERING DATA Drain: Electric: Steam: Water: 2" ODT drain terminal (Floor drain capacity must handle peak water consumption.) Control: 120 volt, single phase, 50/60 Hz, 2 A Vacuum Pump 208/240, 3 phase, 50/60 Hz, 6 A per phase, or 480 volt, 3 phase, 50/60 Hz, 3 A per phase Pressure 50 to 80 psig (3.45 to 5.52 bar), dynamic, condensate free, and 97 percent to 100 percent vapor quality Consumption 185 lbs/hr (84 kg/hour) Peak Flow 335 lbs/hr (152 kg/hour) Size 1" NPT Pressure 20 to 50 psig (1.38 to 3.45 bar), dynamic Consumption 130 gal/hr (495 L/hour) Peak Flow 15 gal/min (57 L/min) Size 1" NPT Operating 26 x 37.5 x 36" (660 x 950 x 910 mm) 3800 lb (1720 kg) Weight: 26 x 37.5 x 48" (660 x 950 x 1220 mm) 4200 lb (1900 kg) 26 x 37.5 x 60" (660 x 950 x 1520 mm) 4700 lb (2125 kg) NOTES: Operating weight includes a full load in the chamber. Water consumption data is based on running one fully loaded Prevac cycle per hour and the machine idling for the remainder of the hour. 6

22 ON OFF POWER ON OFF POWER Double Hinged-Door, Recessed, One Wall Double Hinged-Door, Recessed, Two Walls D 38 1 (965) 47 1 (1194) FW VP EC S 38 3 (965) 36 2 (914) 53.5 (1359) 44 (1118) 36 2 (914) 38 1 (965) 47 1 (1194) D FW VP EC S 38 3 (965) 53.5 (1359) 36 2 (914) 36 2 (914) C 30 2 (762) 4-8 ( ) Wall Thickness C 30 2 (762) 4-8 ( ) Wall Thickness (1886) Typical (1886) Typical (1911) Typical 1 Service Clearance 2 Door Swing (left hand swing shown) 3 Wall Opening Dimensions are inches (millimeters). WATER QUALITY RECOMMENDATIONS Recommended Feed Water Quality for Sterilizers Condition Nominal Conditions Maximum Conditions Temperature F (4-16 C) 70 F (21 C) Total Hardness as CaCO 3 * mg/l 171 mg/l Total Dissolved Solids mg/l 500 mg/l Total Alkalinity as CaCO mg/l 180 mg/l ph Total Silica mg/l 2.5 mg/l NOTE: Because of STERIS's continuing program of research and development, all specifications and descriptions are subject to change without notice. Some options may affect utility consumptions. Obtain certified drawings for design and installation. A B C D E F OVERALL INSTALLED LENGTH Refer To Illustrations. Dimensions are inches (mm). Chamber Length (914) (1219) (1524) (1753) (2057) (2362) (1473) (1778) (2082) (1219) (1524) (1829) (1499) (1803) (2108) (1816) (2121) (2425) (1352) (1657) (1962) 7

23 ON OFF POWER ON OFF POWER ON OFF ON OFF POWER POWER Cabinet Enclosed Single Horizontal-sliding Door Recessed D D 38 1 (965) 38 1 (965) 52 1 (1321) FW VP EC S 70 (1778) 52 1 (1321) FW VP EC S 68 2 (1727) 70 (1778) D E 4-8 ( ) Wall Thickness (1778) (1778) Typical (1911) 1 Service Clearance 2 Wall Opening 38 1 (965) 52 1 (1321) D FW VP EC Recessed, One Wall S Double Horizontal-sliding Door 68 2 (1727) 70 (1778) 38 1 (965) 52 1 (1321) D FW Recessed, Two Walls VP EC S 68 2 (1727) 70 (1778) F F 4-8 ( ) Wall Thickness (1886) Typical (1778) (1886) Typical (1911) Dimensions are inches (millimeters). For further information, please contact: STERIS Corporation 5960 Heisley Road Mentor, OH USA SD , STERIS Corporation All rights reserved. MC (02/01/02) STERIS Offices Worldwide Canada Germany Hong Kong Italy Japan Korea Latin America Singapore Spain United Kingdom This data is intended for the exclusive use of STERIS customers, including architects or designers. Reproduction in whole or in part by others is prohibited.

24 AMSCO CENTURY TM MEDIUM STEAM STERILIZERS 26" X 37.5" SCIENTIFIC APPLICATION This sterilizer is offered in a Prevacuum configuration and is designed for fast, efficient sterilization of heat- and moisture-stable materials in scientific applications. Prevacuum configuration sterilizers are equipped with prevacuum, gravity, liquid, leak test, and daily air removal (Bowie-Dick) test cycles. The 48" and 60" configurations include choice of a single or a double door; 36" configuration provides single door, only. DESCRIPTION Amsco Century Medium Steam Sterilizers are equipped with the latest features in both state-of-the-art technology, and ease of use. Primary Product Features Interior Chamber Dimensions 26 x 37.5 x 36" (660 x 950 x 910 mm) 26 x 37.5 x 48" (660 x 950 x 1220 mm) 26 x 37.5 x 60" (660 x 950 x 1520 mm) The sterilizer can be ordered with one of two door configurations: Hinged Door Model Hinged door with fast operating, loweffort door lock mechanism. Manual door handle lock lever requires a single 30 handle movement to lock or unlock. (Typical only some details may vary.) Horizontal-sliding Door Model Sliding door with quiet, motor-driven cable and pulley mechanism. Power operated door travels horizontally right to left to open and is controlled from the touch screen. The Selections Checked Below Apply To This Equipment SIZE 26 x 37.5 x 36" (660 x 950 x 914 mm) 26 x 37.5 x 48" (660 x 950 x 1219 mm) 26 x 37.5 x 60" (660 x 950 x 1524 mm) STEAM SOURCE Building Steam VACUUM PUMP ELECTRIC SERVICE 208/240 VAC, 60 Hz, 3-Phase, 6A/Phase 480 VAC, 60 Hz, 3-Phase, 3A/Phase DOOR CONFIGURATION Single-door Hinged Horizontal-sliding Select direction of door swing or movement, as viewed from Operating End of sterilizer: Left-hand Right-hand (not available for sliding-door units) * 26 x 37.5 x 36" sterilizers not available in double-door configuration. Double-door* Hinged Door NOTE: Operating end hinge position listed first; non-operating end hinge listed second. Right-hand/Left-hand Right-hand/Right-hand Left-hand/Right-hand Left-hand/Left-hand Horizontal-sliding Door NOTE: Operating end slide direction listed first; non-operating end slide direction listed second. Right-hand/Left-hand SINGLE-DOOR MOUNTING Cabinet Enclosed/Freestanding Recessed DOUBLE-DOOR MOUNTING Recessed through One Wall Recessed through Two Walls OPTIONS Pure Steam Piping RTD Load Probe and F 0 Sterilization Bio-Seal (double door units only) Air Differential Seal (double door units only) Eighteen-cycle Capability 3" Tri-clamp Penetration Integral Electric Steam Generator ACCESSORIES 36" (914 mm) Chamber Length 48" (1219 mm) Chamber Length 60" (1524 mm) Chamber Length Loading Car Transfer Carriage Chamber Track Assembly Single Door Double Door Loading Car, Transfer Carriage, and Track Assembly Single Door Double Door (36" Units, only) Chamber Rack and Shelf Seismic Tie-down Kit Item Location(s) SD744 (05/01/02)