AN ISO 9001:2015 & EN ISO 13485:2016 COMPANY ALLENGERS Autoclaves INSTALLATION/USER MANUAL MEDICAL SYSTEMS LTD. S.C.O. 212-214, SEC. 34-A, CHANDIGARH (INDIA) TEL.: +91-172-6618081-82 FAX: +91-172-2621912 E-mail: exports@allengers.net Website: www.allengers.com Passion for excellence INDEX Sr. No. Description Page No. 1. Introduction 1 2. Technical Specifications 2 3. System Overview 3 4. Parts Descriptions & Electrical Information 4 5. Usage advice & Operating Instructions 6. Preventive Maintenance 7. Troubleshooting 8. Safety/Warning Instructions 5-6 7 8 9 Introduction Allengers Autoclaves Model AA-HE 350 is Electric 350 Ltr Cylindrical Horizontal High pressure sterilization of surgical instruments, dental instruments, material used in laboratory and dressing material & accessories used in medical practise with pressurized steam. Autoclave (Tripple Wall) is used for The sterilizer is based on the principle that microbiological action of saturated steam at elevated temperature is rapid and through. Our all models work on principle of downward displacement of air which is most economical method of obtaining sterilization. This sterilizer is safe, reliable and can be easily handled and cleaned for quicker sterilization cycle, only trained and authorized personnel’s should be engaged for handling of this equipment. Before installation & sterilization, please ensure: a) b) c) d) All parts are indicated in packing list are available with the unit for assembly. Enough space is available for movement and safe operation of the sterilizer. Sterilizer safety provision is intact and correctly functioning. Pure, distilled water (minimum drinking quality water) in available for sterilization. e) Installation is away from anaesthetic/operation area and laboratory and chemical storage area, it should be placed is cool. Well-ventilated area, at a clearly visible and proper height, convenient to the operation. Disclaimer This manual is solely meant for the purpose of guidance and it is not a substitute for professional training and is not intended. Contract to training of our product 1|Page Allengers AA-HE 350– Installation/User Manual Technical Specification of AA-HE 350 Type Power mode Capacity Size Sterilization Temperature Working Pressure Sheet Used Inside Sheet Used Outside Pressure Gauge Valves (Type) Pressure Adjustment Air Insulation In Boiler & Outer Shell PSI range for testing sterilizer Heating Element Wattage Water Indicator Load in (KW) Gasket Used Chamber Thickness Lid Material Jacket Drain Radial Lock Self-locking door Optional Safety feature Optional Features Power Supply Requirement Horizontal Electrical 350 Ltr Size: 22" x 58" 121 to 131°C 15 to 25 psi Stainless Steel Stainless Steel 0 to 30 psi Two manual safety valves Manual pressure safety valve adjustable Mineral wool insulation 15 to 25 psi 12 to 18 KW Water level glass indicator provided 12 to 18 KW Silicon 3 mm Stainless Steel-12 mm Provided Provided Provided Auto purging and Pre and Post vacuum Automatic low water level cut off device Digital Temperature controller Spare basket Low water protection 400V 10% AC, 50 Hz 2|Page Allengers AA-HE 350– Installation/User Manual System Overview: Cylindrical Horizontal Autoclave 1. 2. 3. 4. 5. 6. 7. 8. Chamber Lid Locking Gasket Water level indicator Steam Release valves Safety Valve Double safety valve 25PSI. 9. Water outlet valve. 10. Pressure gauge : Chamber made of thick Stainless steel 304 grade sheet : Lid is made of thick SS 304 grade. : Radial locking. : Provided with silicon gasket. : water level indicator glass. : Provided on the lid to release excess pressure. : Manual pressure release valve provided : This works when double safety fails to works at : The sterilizer chamber is fitted with one water outlet : Sterilizer is fitted with pressure gauge to indicate the Pressure in the chamber. Gauge is easily readable. 3|Page Allengers AA-HE 350– Installation/User Manual Each unit is supplied complete with the following: Sr.No 1. Part Description Sterilizer chamber with lid 2. Pressure Gauge 3. Steam release valve 4. Weight valve [Double safety valve] 5. Safety valve 6. Silicon gasket 7. Immersion heater 8. Water outlet 9. Water level glass indicator 10. Radial Locking 11. Legs Electrical Information: The sterilizer is suitable for use with 400V 10% AC, 50 Hz power supply. The power load of various sizes is as per table here under: Load Chamber Dimension 12-18 KW 22”*58” 4|Page Allengers AA-HE 350– Installation/User Manual Usage advice: Do not use/operate the sterilizer without reading the instruction operation manual supplied to you. The high pressure sterilizer horizontal type is best designed for working up to 25PSI and adjusted for operation at 0 to 25PSI (14 to 25 psi) approx. and corresponding temperature of the saturated steam inside the chamber about 121⁰C. Water used for sterilizing should meet international prescription for soft drinking water, so that items to be sterilized should be free from rust, corrosion, residue to from time according to the item being sterilized. Operating Instructions: a) Open the package supplied Valves and other fittings are intact. Rubber gasket should be free from surface defects & properly placed inside the chamber. b) Place the sterilizer suitable dry place. Keep washed & dampened articles material to be sterilized on the table according to preferred combination. c) Check all the parts of the accessories (valves & gauges) on the lid are correct and in the good condition. (Refer Diagram). d) Keeps the tripod standard the sterilizers chamber resting it on all three-leg points equally at the base of vessels. e) To fill water first check the water outlet valve is closed. Open the lid fill the water 2” above the level of element. Check water level glass indicator for proper water level. To remove excess water, open outlet valve. f) Place the drums loaded with sterilizing material selected. We recommend to use double thickness muslin cloth for dressing packs and as liner for the dressing. Also cover on the bottom & top of the loaded with muslin cloth to prevent wetting. g) Check that the rubber gasket is in appropriate place and is without any damage & swelling. Recommended Exposure Period: All the temperature 121⁰C approx. recommended sterilizing cycle are as under. 1. 2. 3. Gloves, Utensils Surgical pack, Intravenous set etc. solution Drums 15minutes 25minutes 35minutes 5|Page Allengers AA-HE 350– Installation/User Manual a) Heating the water till the pressure gauge needle ascends above zero reading. Note the timing in log book to reach 15psi in pressure gauge b) As soon as steam reaches 15psi (1Kg/cm2) and heating steel continuing the sterilization process start inside the chamber. The temperature inside the chamber is 121 °C approx., which is ideal and most sought for almost all sterilization. c) The safety valve lifts up to release excess pressure being build up beyond 20PSI. d) From 1.5Kg/cm2 (22psi)the pressure EXCEEDS the safe limitation of sterilization of sterilizing. In case if the safety valve fails to release steam on 25psi. Heating must be stopped at this stage immediately. e) On completion of the sterilizing switch off the power supply and allow 2-3 minutes of cooling. Steps to perform after completion of Sterilization Cycle: a) Release the steam by opening steam release valve knob. (Do not open the sterilizer locks when under pressure. b) Exhausted up to ZERO in pressure gauge. c) When the pressure gauge indicates 0PSI open the door handle. d) Open water outlet valve and allow water to drain to prevent from scale depositing in the chamber. e) Remove the sterilized material. f) Use cloth hard gloves for loading & unloading sterilizing material. g) Please keep material after sterilization where free flow of air is available and do not place closed to one another. h) The perforated wooden table is recommended for placing drums. i) Keep open the sliding band of drums for few hours. 6|Page Allengers AA-HE 350– Installation/User Manual Preventive Maintenance: Sterilizers required periodical cleaning. Good care & maintained is required to keep it in excellent working condition. Our sterilizers are of prime quality material and fitting are used in vessel & its accessories. We advise the following care & maintenance activities to be done by an operator/technician engaged in the use of the sterilizer. 1 2 3 4 5 Cleaning of vessel, accessories and associated parts (safety valve, gasket etc.) Change silicon gasket Cleaning, overhauling of weight valves gauges joints etc. Buffing, dressing & polishing& retesting where required. Counter weight calibration and replacement/repair of valve, parts Once a day Once in six months Once in six months Once in Year Once in 2 Year It is recommended that the user may plan to conduct a periodical maintenance programme (PMP) for this product, which will provide maximum durability for the sterilizer. 7|Page Allengers AA-HE 350– Installation/User Manual Troubleshooting: During working of the sterilizer if any problem specified as below happen, please try the recommendation given below. If it is beyond the skill of the operator, a trained technician must be called for it, and the sterilizer should be shut down. Symptoms 1. Sterilizer not working (for both Electric & NonElectric) 2. Steam not building up. (For electric units only) 3. Steam Leaking through the lid Joint Possible Case a) No water in vessels or water level too low. b) Any of the valve is not closed/weight safety absent. c) No power supply in the unit. a) No water in vessel. b) Fault in steam release valve. c) Fault in pressure gauge. d) Fault in immersion heater. a) Fault in gasket/Gasket is not fixing in the chamber. b) Lid not tight. Recommendation a) Open the lid to check the water level below the tripod stand. b) Check all accessories again and put back if removed. c) Check main power supply. a) Stop heating. Check water level indicator; fill water if required up to specified level. b) Close heating system, and slowly open the steam release valve to check the flow of steam. c) A small tapped on the gauge may show the gauge movement if not replace it. d) Replace immersion rod by qualified electrician only. a) Stop sterilization, open the lid and replace gasket if defective or correctly position the gasket in place. 8|Page Allengers AA-HE 350– Installation/User Manual Safety/Warning Instructions: 1. Check the water level, never run the immersion heater dry. 2. Please keep the surrounding area clear off all unwanted articles. 3. Proper place, operation convenience and water proof surface (dry) should be selected for sterilization operation. 4. Never touch or reach the vicinity of this sterilizer to protect the body from bum injury keep children & animal away for sterilization room. 5. Separate the heating source and vessels when the cycle is complete. 6. Do not try to alter the safety valves. 7. Never keep articles on the lid top of the sterilizer and safety valve must be cleared from obstructions. 8. Never apply too much force for opening or closing the lid. Please follow the direction for opening and closing instructions. 9. Never use a hammer for any work on this sterilizer at any time. This will result in very dangerous hazards. 10. Please do not exceed the pressure and time limitation specified for the sterilization time is to be calculating according to the article to be sterilized. Capacity and quantity of water being heating up. Never try to heat the vessel without water in it and never try to pour water into heated dry vessels. 11. Please hang a placard/banner indicating the ‘’sterilizing in operation, Keep away and constantly monitor its operation. A log register for each cycle may also be maintained to verify the effectiveness of sterilizing periodically. 12. Stop sterilizing immediately if any of its parts shows extra ordinary symptoms or if any sound is heard from any parts. 13. Never use this sterilizing for warming or cooking food articles and do not preserve eatables. Disposal Advise: When the sterilizer becomes badly defectives and out of use it will be disposed off in accordance with the state laws and regulation governing the “Recycling and safe disposal of medical device “Metallic items & Bakelite items should be segregated and recycled disposed off separately and a record of the same should be maintained. Since it is a pressure vessel, It usage is strictly permitted only to a trained technician. 9|Page Allengers AA-HE 350– Installation/User Manual