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Please upgrade your browser to improve your experience. STERIS Quick Connects provide flow of chemistry throughout the endoscope lumens and around adapter ports. The SYSTEM 1 endo Processor is validated for efficacy of processing devices including colonoscopes, gastroscopes, bronchoscopes, enteroscopes, duodenoscopes and more. Click OK to extend your time for an additional 0 minutes.Please enter another quantity.The use of non-OEM parts may affect equipment reliability and the regulatory status of your device. The use of non-OEM parts could also negatively impact the performance of your equipment and affect your warranty. Product images shown may be illustrations, 3D renderings or group images to represent a product or product family. Actual products may vary, including by color and texture. STERIS reserves the right to change product images and specifications at any time without notice. A Shop STERIS account allows you to purchase products, view order history, download invoices and save shopping lists. Registration is easy. Simply click here to register your account. Please upgrade your browser to improve your experience. The gentle use-dilution protects delicate surgical instruments, including multi-channel flexible surgical endoscopes. The use-dilution is neutral pH, and rinses safely down the drain. Quick Connect adapters are designed to leak to ensure sterilant use dilution reaches all surfaces and angles of the device ports. Its compact footprint and rapid 23 minute cycle time makes it convenient and ideal for a variety of locations. Compared to high-level disinfection, it provides a higher level of reprocessing assurance for heat-sensitive critical and semi-critical devices such as flexible or semi-rigid endoscopes. Sign in Forgot Password. My Bench Close Sign In Not A Member. Sign Up Join MedWrench OK name type Receive Summary Emails. In 23-minutes, you're ready for the next procedure.
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Liquid chemical sterilization provides fast reprocessing ease for cleaned, reusable, immersible, and heat-sensitive critical and semi-critical devices. Its compact footprint makes SYSTEM 1E processor convenient and ideal for a variety of locations. The SYSTEM 1E processor performs two quick rinse cycles, reducing energy and water consumption. Running a 23-minute cycle, the SYSTEM 1E processor minimizes device downtime between patients. This gentle use-dilution protects delicate surgical instruments, including multi-channel flexible surgical endoscopes. Providing a high standard of patient care, whether it’s in your OR or GI department, the SYSTEM 1E processor will help you process your devices with confidence. Reply 1 Reply -surgicenter 4 years ago 4 years ago Residual fluid in sterilant cup at end of cycle I am once again reaching out to see if any other facilities experience residual fluid in the sterilant cup at the end of a cycle. This happens to us frequently. It occurs in both of our units with all of our trays. The amount of fluid left in the container can be a slight residual to a significant amt up to 1 inch or more left in the container. The container design, of course, did change from the System 1 in which residual fluid was obvious as it was in the bottom of the container whereas the 1E containers reservoir sits in the higher portion of the cup. The release parameters do indicate the cup must be empty but again we experience residual fluid almost on a daily basis. Thank You. Reply FEATURES By continuing to browse the site you are agreeing to our use of cookies. Please review our Privacy Policy for more details. All Rights Reserved. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
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The notification letter describes the product subject to field correction and the problem that exists with the language omission present in the printout display and Operator Manual messages which warn of an incomplete or aborted processing cycle. The notification goes on to state that there is no health hazard involved in this error, as the users are still made aware that the processing cycle has not been successfully completed. It also states that a STERIS Service Representative will be contacting each facility in order to schedule installation of the new software. The notification also provides the customers with a 1-800 telephone number for STERIS Field Service Dispatch, to be used if the customers have questions or want to request additional information. It also provides a local telephone no. 1-440-392-7455, for obtaining additional information from the firm's Director, Div.The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.It is possible that some links will connect you to content onlyIn the case of any discrepancy in meaning, the English version is considered official. Thank.
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Report this Document Save Save System 1E Maintenance Manual P764333-674 For Later 0 ratings 0% found this document useful (0 votes) 27 views 190 pages System 1E Maintenance Manual P764333-674 Uploaded by Alberto MH Description: Full description Save Save System 1E Maintenance Manual P764333-674 For Later 0% 0% found this document useful, Mark this document as useful 0% 0% found this document not useful, Mark this document as not useful Embed Share Jump to Page You are on page 1 of 190 Search inside document Browse Books Site Directory Site Language: English Change Language English Change Language Quick navigation Home Books Audiobooks Documents, active Collapse section Rate Useful 0% 0% found this document useful, Mark this document as useful Not useful 0% 0% found this document not useful, Mark this document as not useful Collapse section Share Share on Facebook, opens a new window Facebook Share on Twitter, opens a new window Twitter Share on LinkedIn, opens a new window LinkedIn Copy Link to clipboard Copy Link Share with Email, opens mail client Email. Two of 24 spore strips, containing 10 6 B. subtilis showed a small number of survivors (less than 10 per strip). No significant damage to the endoscope was observed although the number of cycles tested was small (i.e. 31). The advantage of the system is that staff are not directly exposed to the agent, but the costs per cycle are higher than glutaraldehyde, since peracetic acid is not renewed. Unlike other automated processers the Steris machine has no cleaning cycle. Recommended articles No articles found. Citing articles Article Metrics View article metrics About ScienceDirect Remote access Shopping cart Advertise Contact and support Terms and conditions Privacy policy We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies. Contact Us to Register Your Interest Already a member.
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All personnel involved in the use and maintenance of this equipment must carefully review and comply with the Safety Precautions and instructions contained in this manual. These instructions are important to protect the health and safety of personnel operating this processor and should be retained in a conveniently accessible area for quick reference. For a 50 Hz processor, also read Operator Manual - Information Supplement For 50 Hz Processors (P920501-322) for specific information and features. Complete instructions for uncrating and connecting utilities, as well as the equipment drawing, have been provided. If they are missing, contact STERIS for replacement copies, providing the serial number of the processor. STERIS provides a line of accessories and Flow Units for use with this processor. A STERIS representative will gladly review these with you. Please familiarize all users with this manual and store in an accessible location. Advisory IMPORTANT: This processor is specifically designed to only process endoscopes as outlined in this manual and in the Endoscope Quick Reference Guide. If there is any doubt about a specific endoscope material or product, contact STERIS. A listing of the Safety Precautions to be observed when operating and servicing this processor can be found in SECTION 1 of this manual. Do not operate the equipment until you have become familiar with this information. If the processor is equipped with an optional Automated Leak Test Assembly, use this Automated Leak Test Assembly only as specified and described in this manual. Any alteration of this equipment not authorized or performed by STERIS will void the warranty. Alteration of this equipment which could adversely affect high level disinfection efficacy may violate national, state and local laws or regulations and could jeopardize your insurance coverage. All rights reserved. For current MSDS sheets, contact STERIS.
The Reliance EPS automated process, detailed below, is scientifically proven to offer the highest quality and outcomes you have come to expect from STERIS. Optional Washing Phase The Reliance EPS Processor offers a programmable washing phase. The phase can be programmed on or off, utilizing one or two washing phases per processing cycle, and an adjustable wash time between five and ten minutes. The Reliance washing phase does not replace manual cleaning of the endoscopes. Please refer to endoscope manufacturer guidelines for cleaning instructions. High Level Disinfection The high level disinfection portion of the cycle is a non-optional, ten-minute, pre-programmed phase. The processor will automatically dilute the Reliance dry chemistry, flow the high level disinfection solution through the endoscope lumens and spray it over their external surfaces, without user exposure to the disinfection solution. The STERIS chemical indicator validated for use with the Reliance EPS is used as an independent monitor of the Reliance EPS Endoscope Processing Cycle.Final Air Purge The final stage of the Reliance EPS Cycle is an air purge phase using HEPA-filtered air. The air purge helps to remove excess rinse water from the processed endoscopes and accessories. This final air purge is preset to run for four minutes; additional air purge time (up to a total of 30 minutes) may be programmed by the supervisor. If the endoscopes and accessories are not removed after the programmed time, the air purge will continue to run for a maximum of 60 minutes. Documentation The Reliance EPS Processor prints a detailed cycle summary at the end of each cycle. With the optional bar code reader, these printouts can also include the identification numbers for the operator, patient, device, physician and procedure.
Indications For Use The Reliance EPS Processor is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories. The Automated Leak Test Assembly is offered as an option and is installed at the factory. The automated leak test is performed at the start of a cycle, prior to fluid circulation within the processor. The automated leak test is intended to detect leaks in flexible endoscopes prior to the start of the processing cycle. The automated leak test IS NOT a substitute for the manufacturer's manual leak test. IMPORTANT: Operator must ensure all items have been prepared for immersion, manually leak tested (as per the instructions of the endoscope manufacturer) and manually cleaned before placing them in the Reliance EPS Processor. Refer to Endoscope Quick Reference Guide for more details.Do not substitute any other chemistry or chemical indicator product. Reliance dry chemistry is a proprietary, two-part, dry, single-use germicide, designed to deliver high level disinfection solution in the Reliance EPS Processor. A STERIS chemical indicator that is validated for use with the Reliance EPS is a single use chemical indicator designed to change from the color of the “START” reference block on the label to the “ENDPOINT” reference block upon exposure to an effective dose of peracetic acid generated during the Reliance EPS Cycle. Service Information A thorough preventive maintenance program is essential to help ensure safe and proper processor operation. This manual contains maintenance schedules and procedures which should be followed for satisfactory equipment performance. Customers are encouraged to contact STERIS concerning our comprehensive annual maintenance program.
Under the terms of the program, preventive maintenance, adjustments and replacement of worn parts are performed on a scheduled basis to help ensure equipment performance at peak capability and to help avoid untimely or costly interruptions. STERIS maintains a global staff of well-equipped, qualified service technicians to provide this service, as well as expert repair services. Please contact STERIS for details. In North-America: 800-548-4873 Other countries: Contact local STERIS representative. Any translation must be made from the base language document. WARNING indicates the potential for personal injury and CAUTION indicates the potential for damage to equipment. For emphasis, certain Safety Precautions are repeated throughout the manual. In an emergency, stop cycle by pressing STOP touch pad twice to abort cycle. Wait for processor to complete Abort sequence. Wear appropriate Personal Protective Equipment (PPE) when reaching into chamber. Regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment. Contact STERIS to schedule preventive maintenance. Repairs and adjustments to this equipment must be made only by STERIS or STERIS-trained service personnel. Nonroutine maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury, result in improper equipment performance or result in costly damage. Contact STERIS regarding service options. When working with compressed air, flying debris and particles may present a hazard to personnel in immediate area. Personal eye protection must be worn when working with compressed air. Do not service processor unless all utilities have been properly locked out. Always follow local electrical codes and safety-related work practices. Fasteners and star washers are used to ensure protective bonding continuity. Always reinstall any star washer which may have been removed during installation or servicing.
CIP 200 Acid-Based Process and Research Cleaner is corrosive and can cause adverse effects to exposed tissues. Do not get in eyes, on skin or swallow. Read and follow all precautions and instructions on cleaner label and in Material Safety Data Sheet (MSDS) prior to handling CIP 200 Acid-Based Process and Research Cleaner Bag-in-a-Box container or servicing cleaner injection pump. Wear appropriate Personal Protective Equipment (PPE) whenever handling detergent or servicing cleaner injection pump and lines. Product may cause skin irritation. Do not get on skin or in eyes. Read and follow all precautions and instructions on cleaner label and in Material Safety Data Sheet (MSDS) prior to handling Klenzyme Bag-in-a-Box container or servicing cleaner injection pump. Wear appropriate Personal Protective Equipment (PPE) whenever handling cleaner or servicing cleaner injection pump and lines. Laser radiation. Do not stare at bar code reader beam. Allow processor to cool down. Avoid inhaling fumes from chamber and contact with any remaining solution. If undissolved powder is present in container or Reliance CDS at the end of cycle, load cannot be considered high level disinfected. See Troubleshooting section for procedure. Before operating processor, always firmly push endoscope processing support into manifold connectors at the back of chamber. If support is not positioned correctly, door will not close, damage may result and processor will be unable to effectively process load. Before starting a cycle, ensure rotary spray arms on endoscope processing support and within chamber are not obstructed and rotate freely. If expiration date is not valid, use a new Reliance dry chemistry container or a new chemical indicator strip. Failure to do so may result in ineffective processing. Correct function of the system is only ensured after any diagnosed errors have been found, corrected and a successful processing cycle has been completed.
Endoscopes and accessories are not adequately processed, rinsed and air purged when processing cycle is aborted. REPROCESS LOAD. Failure to process endoscopes and accessories within 30 minutes after manual cleaning may result in ineffective processing. Follow all applicable instructions provided by the endoscope manufacturer for preparing endoscope and accessories for immersion. If chemical indicator strip exhibits incomplete color change, load cannot be considered high level disinfected. If chemical indicator strip exhibits incomplete color change, call STERIS. If chemical indicator was not used, load cannot be considered processed. Load must be reprocessed using a new Reliance dry chemistry container and a chemical indicator strip. Inspect Reliance dry chemistry container for damage prior to use. Do not use damaged containers; if damage is observed, follow directions for disposal in Reliance dry chemistry package insert. Only use Reliance dry chemistry in Reliance EPS Processor. Do not substitute any other product for Reliance dry chemistry. STERIS makes no claim of processing efficacy when these processing instructions are not followed. Storage of Reliance dry chemistry container should be in a clean dry location. Reliance dry chemistry container should not be exposed to extreme heat or humidity. Refer to package insert for instructions. To avoid equipment damage and help ensure processing efficacy, always follow directions when loading items in endoscope processing support. Using washing phase of the cycle does not replace the requirement for manual cleaning. When placing an endoscope in control handle boot, ensure endoscope suction barb is not trapped in the flaps of universal cord port. Also ensure light guide cable is correctly placed between the flaps of universal cord port. Carefully remove endoscopes and accessories from control handle boot or accessory basket. Fragile parts may be damaged if caught on boot latches or mesh basket.
Inspect leak test hose assemblies and chamber flexible connections for presence of water prior to processing. Water in tubing during automated leak test may cause damage to endoscope. Remove all endoscopes, accessories and Flow Units from control handle boots, accessory pegs, valve irrigators, large mesh basket or accessory basket before performing a D-SHORT or D-LONG cycle. Remove any automated leak test hoses present in endoscope processing support before performing a D-SHORT or a D-LONG cycle. Performing a decontamination cycle (D-SHORT and D-LONG) with automated leak test hose assemblies present may cause water to enter hoses. Inspect leak test hose assemblies for presence of water prior to processing a cycle. Water in tubing may cause damage to endoscopes. To ensure cleanliness during operation and to avoid damage to zinc-coated steel, wipe any cleaner spills or drippage inside Bag-in-a-Box compartment. Clean any surface that might have been in contact with any cleaner inside Bag-in-a-Box compartment. Use a soft damp cloth and a mild detergent to clean control panel touch pads. Splashing water or any other liquid will damage control panel touch pads. Use silicone lubricant to lubricate squeeze tubes. Petroleum-based lubricants, such as petroleum jelly or grease, will damage squeeze tubes. Wear clean gloves when replacing air supply filter cartridge. Do not touch cartridge with bare hands to prevent oils from being deposited. Open plastic wrapping and hold filter cartridge through wrapping when inserting into filter housing. When using insertion tube sleeve, ensure that sleeve handle is pushed down. Insertion tube must be inserted over sleeve handle to avoid possible damage. 1-4 920011-649 Operator Manual Safety Precautions Page 17 The table below contains symbols which may be on your Reliance EPS Processor components: Table 1-1. Definition of Symbols Symbol Definition Protective Earth (Ground). Warning! Risk of Electric Shock. Attention.
Refer to Manual For Further Instructions. Fuse Identification. Lubricate Cleaner Squeeze Tubes With Silicone Lubricant. Refer to Reliance dry chemistry package insert for storage conditions. A seismic anchorage system (accessory; based on California requirements) is available for high-risk seismic zones. 2-1 Installation Verification Operator Manual 920011-649 Page 20 2.2 Installation Verification An equipment drawing (920-011-656), showing all of the utility and space requirements, was shipped after the order for this equipment was received. The clearance space specified on the equipment drawing is necessary for proper installation, operation and maintenance. If these documents are missing or misplaced, contact STERIS and provide the serial number of the processor. Replacement copies will be shipped promptly. Shutoff valves must be compliant with the local occupational health and safety regulations, as well as electric and plumbing codes. ? Disconnect switches (not provided by STERIS), capable of being locked in OFF position for maintenance purposes, are installed in electrical supply lines near the processor. Disconnect switches must be compliant with local occupational health and safety regulations, as well as electric codes. NOTE: If processor is installed next to other equipment, shutoff valves and disconnect switches should be located so service can be shut off to one piece of equipment at a time. ? Processor is positioned, as shown on equipment drawing, with required clearance space and in relation to building supply lines. ? Processor is level. Adjust leveling casters if necessary. ? Dual Pre-Filter and Pressure Regulator Assembly (required accessory), pressure gauge and manual ball valve (with dual pre-filter kit) are installed as specified on equipment drawing. ? Measure building hot and cold water supply pressures at shutoff valves.
Measure building hot water supply temperature downstream of Dual Pre-Filter and Pressure Regulator Assembly (required accessory). Temperature must be within range specified on equipment drawing (920-011-656). NOTE: Temperature range specified on equipment drawing gives optimal cycle time. Supply hot water heater with hot water. Run water heater output into an antiscald mixing valve. Refer to SECTION 8, RECOMMENDED SPARE PARTS AND CONSUMABLE PRODUCTS, or contact STERIS for ordering information. IMPORTANT: After a few weeks of operation, inspect processor for leaks. It effectively removes a wide range of process residues, from inorganic salts to particulate carbon. NOTE: For a 50 Hz processor, also refer to Operator Manual Information Supplement For 50 Hz Processors (P920501-322) for specific components. 3.1.1 Chamber Door See Figure 3-1. A front-loading, drop-down door is provided to facilitate loading of the processor. The door is constructed of 316 stainless steel covered with a plastic panel. The panel is strong and easy to clean. A tempered glass window allows the operator to view the chamber interior while a cycle is in progress. Panel and glass window remain relatively cool to the touch. A microswitch prevents a cycle from starting if the door is not fully closed. The top two shelves are designed to receive Bag-in-a-Box containers and are provided with specially-designed connectors. The endoscope processing support is automatically connected to these manifold connectors when positioned correctly in the processor chamber. A removable debris screen at the bottom of the chamber prevents large debris from entering the piping system and pump. The screen is provided with a handle and is easily removed for cleaning. The peristaltic cleaner injection pumps automatically inject the correct quantity of cleaner during the appropriate cycle phase. The pumps are conveniently positioned behind the front service access panel, for easy maintenance.
Transition Plan Overview (attached hereto as Exhibit A and incorporated by reference herein), which requires, among other things: that A copy of the Certificate of Medical. Necessity form and the STERIS Transition Guidance referenced in the Transition Plan Overview are attached hereto as Exhibits B and C, and incorporated by reference herein.Defendants shall provide a report as described in the Transition Plan Overview.Within ten (10) calendar days after entry of this Decree, STERIS shall submit to FDA a written statement detailing its proposed timing and method of destruction, and STERIS shall not commence such. The immediately preceding two sentences shall not apply to any unused SSI devices,Defendants understand and agree that any devices manufactured under this paragraph may have to be destroyed in the event FDA does not approve or clear such application or notification. During such inspections, FDA representatives shall be permitted ready access toThe inspections shall be permitted upon presentation of a copy of this Decree and appropriate credentials. The inspection authority granted by this Decree is separate from, and in addition to, the authority to make. The costs of such inspections shall be borne by Defendant STERIS at the standard rates in effect atDevices. In the event that Defendants become associated, at any time after the entry of this Decree, with new Associated Persons, Defendants shall within fifteen (15) calendar days of such association, (a) provide a copy of this Decree toDefendants shall ensure that the Decree remains posted in the employee common areas for no less than twelve (12) months. Within thirty (30) calendar days of the date of entry of this Decree, Defendants shall provide to FDA an affidavitDefendants shall provide a copy of this Decree to any prospective successor or assignee at least thirty (30) calendar days prior to any sale orAct, or its implementing regulations. 11.
The following process and procedures shall apply when FDA issues an order underIf FDA affirms or modifies its order, it shall explain the basis for its decision in writing. The written notice of affirmation or modification shall constituteIn such case, Defendants shall, upon receipt of such order, immediately and fully comply with the terms of that order. Should. Defendants seek to challenge any such order, the order shall be deemed to be final agency action and the Defendants shall begin compliance with the order while they petition this Court for relief. The costs of FDA supervision, inspections, investigations,Defendants understand and agree that the liquidated damages specified in this paragraph are notAll decisions conferred upon FDA in thisDefendants have met the foregoing criterion, Plaintiff will not oppose such petition. 17. The obligations under this Decree. If, and for so long as, an individual Defendant or an employee of STERIS ceases to be employed by or act on behalf ofHowever, any such petitions shall not become effective or stay the imposition of any payments under this Decree unless granted by FDA in writing. Chief Executive Officer and President Department of Justice P.O. Box 386 General Counsel Department of Health Counsel Litigation MARC L. CADEN GCF-1 Rockville, MD 20857 In order for a Customer to receive this continued support, a Customer must submit a Certificate of Medical Necessity (CN) to STERIS that describes andHealthcare facilities and distributors will have until June 18, 2010, to complete and return the CN to STERIS. After June 19, 2010, STERIS will cease support of its SYSTEM 1 at any facilityProduct Availability. SYSTEM 1 units now in use to currently-labeled operating parameters until August 2, 2011, or the Customer is able to transition to a legally-marketed and acceptable alternative to the SYSTEM 1, whichever first occurs.