Plasmapp STERLINK FPS-15s Plus User Manual

Low temperature plasma sterilizer

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FPS-15s Plus (FPS-15s

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User Manual

Document No.: PLA-UM-SMU-002

Low Temperature Plasma Sterilizer

Plasmapp Co., Ltd.

Revision in April 2022

Language: KR □ EN ■ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □

Language: EN

STERLINK™ FPS-15s Plus 사용자 설명서

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Summary of Contents for Plasmapp STERLINK FPS-15s Plus

Page 1 Document No.: PLA-UM-SMU-002 Low Temperature Plasma Sterilizer Plasmapp Co., Ltd. Revision in April 2022 Language: KR □ EN ■ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □...
Page 2 MedNet GmbH Borkstraße 10, 48163 Münster, Germany Plasmapp’s Customer Service Center 1544-0508 Plasmapp International Customer Support (Contact your local Plasmapp Customer Support Representative.) http://plasmapp.com 2020 Plasmapp Co., Ltd. All rights reserved. ⓒ The products mentioned herein are the trademarks of their respective owners. It may not be reproduced, adapted, or translated by any process without prior written permission.
Page 3 • Changed product photos • Added a sticker roll photo to Fig. 3.3- Printer Label Sticker • Changed the CI photo • Changed the phone number of Plasmapp’s Customer Service 2020. 6. 23 Center • Added the address of the Daegu office •...
Page 4 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Table of Contents 1. Introduction 1.1. How to use this manual 1.2. Contact Us 1.3. Contact information 2. Safety Information 2.1. Personal Safety and First Aid 2.2. Personal Protective Equipment 2.3. Cautions, Warnings, and Notes 2.4.
Page 5 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 4.6.1. Sterilization Trays 4.6.2. Tray Mat 4.6.3. Packing 4.6.4. Loading 5. Operation 5.1. Before you start 5.2. Start-up and Preheating 5.3. Preparations for loading 5.4. Mounting Cassettes 5.5. Starting the sterilization cycle 5.6. Progress and completion of the cycle 5.7.
Page 6 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 8.1. Manual Maintenance 8.1.1. Cleaning the exterior/interior of the sterilizer 8.1.2. Replacing the Label Printer 8.1.3. Routine maintenance of the sterilizer 8.2. Sterilization Cassette 8.3. Movement, long-term shutdown, and disposal of the Sterilizer 8.3.1.
Page 7 Plasmapp’s Customer Service Center (phone: 1544-0508). If you live abroad, please visit Plasmapp's local Customer Service Center near you. You can also contact us through Plasmapp’s website (http://plasmapp.com). Language: EN...
Page 8 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 1.3. Contact information 1.3.1. Manufacturer Company Plasmapp Name Add. (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea Phone 1544-0508 Website http://plasmapp.com Company Plasmapp Name Add. (18151) 372, Dongbu-daero, Osan-si, Gyeonggi-do, Republic of Korea...
Page 9 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 1.3.3. European Certification Authority Company MTIC InterCert S.r.l. Name Add. Via G. Leopardi, 14, 20123 Milano (MI), Italy Phone +39 02 97071800 Website http://www.mticert.org 1.3.4. Distributor in Europe Company MedNet GmbH Name Add.
Page 10 2. Safety Information Chapter Plasmapp places the highest importance on user safety, and this chapter provides the information that can help you use the sterilizer system safely. Before using the sterilizer, you should read and understand the safety information and instructions specified in this chapter.
Page 11 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Warning! There is a risk of skin injury. If hydrogen peroxide comes in direct contact with the skin, it may cause severe inflammation. If it comes contact with your skin, immediately flush your skin with plenty of running water.
Page 12 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 2.3. Cautions, Warnings, and Notes WARNINGs and CAUTIONs are accompanied by a triangular symbol and are printed in bold italics. A warning identifies the events or conditions that may cause serious injuries or death, and a caution identifies the events or conditions that may cause serious damages to the device.
Page 13 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Chapter 3. Overview of the Sterilizer 3.1. Purpose The STERLINK™ FPS-15s Plus Sterilization System is a Low Temperature Plasma Sterilizer for inactivating microorganisms that remain in metal and non-metal medical appliances and surgical instruments at low temperature. It is effective, safe, fast, affordable, easy to use, and reliable by providing a variety of sterilization solutions.
Page 14 The pre-validation has shown that this sterilizer can reach a SAL of 10-6, including lumens, under worst-case conditions. For additional technical information related to validation, please contact Plasmapp or your local Plasmapp’s Customer Service Center. 3.3. Sterilization Cycle The STERLINK™ FPS-15s Plus sterilization system is designed to operate in two different...
Page 15 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Particularly, to ensure user safety, an optimized completion process is carried out by measuring the remaining sterilant with an independent pressure sensor of the sterilizer. The following table represents a brief description of the sterilization cycle for each mode.
Page 16 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 3.4. Sterilization systems and accessories The accessories for the STERLINK™ FPS-15s Plus include carts and printers. The figure below shows the entire sterilizer system, including accessories. Fig. 3.1 STERLINK™ FPS-15s Plus Sterilization System This product has a power supply cable and cord on its back, and is connected to a grounding conductor for protection against electric shock.
Page 17 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Fig. 3.2 STERLINK™ FPS-15s Plus Sterilization System The printer is designed to be connected to the USB connector on the back of the sterilizer. In addition, it can improve the mobility of sterilizer carts. For more details about the report, please refer to ‘Chapter 7 Reports and Data’.
Page 18 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 3.5. Sterilization Cassette The STERLINK™ FPS-15s Plus system has three modes to automatically recognize barcodes that are printed on each Sterilization Cassette: STERPACK™, STERPACK™ Plus, and STERLOAD™. The barcode contains the information about the type and the manufacturing date of Sterilization Cassettes.
Page 19 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Fig. 3.6 Chamber Mode of the STERLOAD™ Sterilization Cassette Each cassette has two built-in cells containing the same amount of sterilant (hydrogen peroxide), so one complete sterilization cycle can be performed while repeating the same sterilization process using each cell.
Page 20 If you have any questions about the processes or the materials of the device, please contact the medical device manufacturer or your local Plasmapp’s Customer Service Center. Warning! Breach of warranty Improper use may cause damages to the equipment, and such damages will not be covered by the manufacturer's warranty.
Page 21 As more product tests are completed, the list of compatible items will continue to increase. It will be updated if there is any new information. If you have any questions, please contact the medical device manufacturer or your local Plasmapp’s Customer Service Center. Caution! Risk of damage to medical instruments or the sterilizer Do not sterilize the items or materials that are not permitted for use in this sterilizer.
Page 22 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 4.4. Instructions for preparing the items to be sterilized All items should be cleaned, rinsed, and thoroughly dried before being put into the STERLINK™ FPS-15s Plus sterilizer. If a medical device with too much moisture is put into the sterilizer, the cycle may be automatically canceled.
Page 23 Chamber Mode. ▪ Do not use paper pouches, sterilization wraps containing cellulose, or cotton. ▪ Do not use the wraps or packaging not approved by Plasmapp or the materials specified in ‘4.3 Things that cannot be processed by the sterilization system’.
Page 24 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. diffuses evenly between the loaded items. ▪ If possible, keep the pouch upright. Arrange the pouches with the transparent side of the pouch facing the opaque side of the next pouch. Do not stack pouches on top of each other.
Page 25 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Chapter 5. Operation 5.1. Before use When using the STERLINK™ FPS-15s Plus sterilization system, follow the instructions specified in ‘Chapter 4 Preparation of Medical Devices’, and be sure to read and understand the operating instructions and precautions provided in this user manual.
Page 26 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Warning! Hydrogen peroxide is a caustic. Concentrated hydrogen peroxide can cause corrosion of the skin, eyes, nose, throat, lungs, and stomach. Make sure to wear latex, PVC (vinyl), or nitrile gloves at all times when removing items from the sterilizer in the event of cancellation of the process or occurrence of errors.
Page 27 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 5.2. Start-up and Preheating 1. Turn on the main power switch on the back of the sterilizer. 2. When the power is turned on, the sterilizer will be automatically preheated. 3. Close the door during the preheating process. Preheating may take up to 40 minutes.
Page 28 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 5.3. Preparations for loading Ensuring that sterilization conditions are met during the sterilization cycle is one of the most important issues in sterilization. Using Biological Indicators (BI) is one way of ensuring that the sterilizer is working properly.
Page 29 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Warning! Hydrogen peroxide residues may still remain. Make sure to wear latex, PVC (vinyl), or nitrile gloves at all times when handling loaded medical devices in the event of the cancellation of the process, or the occurrence of errors.
Page 30 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Warning! Beware of hot surfaces immediately after sterilization. Immediately after the sterilization cycle, the interior of the sterilizer may be hot. NEVER touch the chamber and the interior of the sterilizer with your bare hands or gloved hands.
Page 31 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Name Description The result of the barcode scanning of the loaded cassette is Barcode displayed. It indicates the sterilization mode determined by the Mode barcode. Door It indicates the status of the door.
Page 32 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 5.6. Progress and completion of the cycle The SR process begins with the preparatory process, including measurement of residual moisture, drying, and rise in temperature. Fig. 5.4 Screens showing the drying and sterilization processes...
Page 33 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Name Description status The status image flashes during the SC process. Date The date of the sterilization cycle is displayed. Cycle time The total cycle time is displayed. Mode The mode of the completed sterilization cycle is displayed.
Page 34 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 5.7. Cancellation of the Sterilization Cycle You may have to cancel the cycle for some reason before it is completed. When pressing the ‘STOP’ button, the ‘Confirm’ message will be displayed on the screen. The cycle cancellation cannot be undone once the user has confirmed it.
Page 35 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Name Description Beware of It emphasizes that a user must not touch the sterilizer’s door handling door during the cancellation process. Beware of The status image flashes during the sterilization process. sterilization When clicking the ‘User Confirm’ button, it will go to the Confirm ‘Ready’...
Page 36 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 5.8. Handling sterilized loads After the cycle is completed, the sterilized loads can be validated based on chemical and biological indicators. 5.8.1. Testing by using chemical indicators After checking whether or not the chemical indicator shows the intended color change,...
Page 37 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Cycle Completion Procedures End of the sterilization cycle Review of the output Indicating that the process is Display errors completed Validation by Re-sterilization using chemical after cycle indicators cancellation The color of the...
Page 38 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Procedures to Validate the Sterilization Cycles by Using Biological Indicators Biological indicators No change in color Changes in color or (purple or maintained turbidity (purple -> turbidity) yellow) It does not meet the...
Page 39 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Chapter 6. Tasks based on privileged access and administrative privileges 6.1. Outline The STERLINK™ FPS-15s Plus Sterilization System automatically implements the STERLINK™ sterilization process by using the embedded software. This chapter covers how to control the configuration of the STERLINK™ FPS-15s Plus Low Temperature Plasma Sterilizer.
Page 40 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. The service administrative privileges are only available to Plasmapp's service personnel. ▪ Software update ▪ Modifying process parameters 6.3. Additional utilities menu The additional utilities menu of ‘Configuration’ is only available to administrators, or users with service level access.
Page 41 When this happens, you can use the “Door Open” function to force the door open. It may take about 10 seconds to execute this function. If the problem persists, please contact Plasmapp or your nearest local Plasmapp’s Customer Service Center.
Page 42 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Chapter 7. Reports and Data 7.1. Reports Upon completion of the sterilization cycle, the STERLINK™ FPS-15s Plus sterilization system automatically creates a cycle report. The completed report summarizes the information on cycle date, time, process mode, all sterilization cycle results, etc.
Page 43 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. When a user selects the ‘Print’ button, the label printer will print a summary report that shows the details on the device status, sterilization cycle, and cassette. This summary report is useful for record keeping, and label printing allows for convenient tracking of information on sterilized loads.
Page 44 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Fig. 7.3 Long-format reports of successful or unsuccessful cycles 7.2. Data The STERLINK™ FPS-15s Plus Sterilizer System can create, store, display, and print the cycle data. When connected to the Internet, the sterilizer can upload the cycle history files to the ITS server.
Page 45 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Chapter 8. Maintenance The STERLINK™ FPS-15s Plus is a top-class sterilizer for optimal sterilization cycles. The sterilizer can be damaged with continued use, so proper maintenance is required to ensure reliable sterilization cycles, including user safety. This chapter describes the functions and types of parts required to maintain the STERLINK™...
Page 46 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. You can clean the chamber inside the sterilizer with a soft cloth or a cloth lightly dampened with water. Observe the following guidelines when cleaning the interior of the sterilizer. 1. Be sure to turn off the sterilizer before cleaning the interior.
Page 47 8.1.3. Routine maintenance of the sterilizer The level of use for each sterilizer is indicated on the user registration ITS . Contact your local Plasmapp’s Customer Service Center for instructions on maintaining the sterilizer, depending on your level of use. 8.2. Sterilization Cassette Hydrogen peroxide (formula: H ) contained in the cassettes of STERPACK™,...
Page 48 US Environmental Protection Agency and many international environmental organizations. For more details, please contact Plasmapp or your local Plasmapp’s Customer Service Center. 8.3.2. How to store the sterilizer Be sure to store the product in a location that meets the following requirements: ▪...
Page 49 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. facilities - Install traps in drains and seal areas that pass through walls, install insect screens at exhaust and ventilation openings, etc. ▪ The temperature should be between 10℃ and 40℃, and the humidity level should be kept below 85%.
Page 50 Most of the time, it can be resolved by correcting the causes of the problem, and returning the sterilizer to normal status. However, if it is still difficult to determine the likely causes and the ways to resolve the problem, please contact Plasmapp or your local Plasmapp’s Customer Service Center.
Page 51 Icon for delaying software updates Caution! The sterilizer may be damaged If the power is turned off during the software update, the sterilization system may be damaged. If any trouble arises, please contact your nearest Plasmapp customer service representative. STERLINK™ FPS-15s Plus User Manual...
Page 52 Therefore, the user should be able to identify and understand such errors. If the problem persists, please contact Plasmapp or your local Plasmapp’s Customer Service Center Fig. 9.3 Screen showing user errors...
Page 53 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. 9.4. Sterilization Cassettes-Related Errors The STERLINK™ FPS-15s Plus is designed to automatically initiate a sterilization cycle based on the barcode information provided by the Sterilization Cassette. For barcode- related errors, the cause is visually displayed.
Page 54 Most system errors are related to loading problems. However, they can also be caused by malfunctions of the STERLINK™ FPS-15s Plus sterilization system. If the problem persists, please contact Plasmapp or your local Plasmapp’s Customer Service Center. Fig. 9.5 Screens that appear when a system error occurs...
Page 55 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. If the power of the sterilizer system is abnormally shut off during the sterilization process, the following screen appears when you turn on the power again. The purification process is performed to ensure user safety. It may take several to tens of minutes before it is converted back to the ready state after completion.
Page 56 (Error Codes) on the “History” screen, and take necessary actions by referring to the Error List below. If the problem persists, please contact Plasmapp or your local Plasmapp’s Customer Service Center. [ ERROR LIST]...
Page 57 Plasmapp Co., Ltd. Attachment A. Warranty 1. The manufacturer, Plasmapp Co., Ltd., warrants the STERLINK™ FPS-15s Plus Sterilization System to be free from any defects in materials and workmanship for one year from the date of delivery. 2. The warranty is limited to manufacturing defects or defects occurring in normal use. You should identify the defect, and notify the manufacturer to avail of a warranty.
Page 58 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Attachment B. Cassettes, consumables, trays, and accessories B1. Sterilant Cassettes Name Descriptions/Specifications Fig. Impermeable pouch containing the sterilant for the POUCH mode - Size: 135 mm × 280 mm STERPACK™ - Made of: PP/NY - Sterilant: Hydrogen peroxide (Concentration: 58~59.5%)
Page 59 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. B2. Consumables Name Descriptions/Specifications Fig. STERILIZATION POUCH FOR CHAMBER MODE Tyvek™ - Pouch Width: 100 mm pouch - Total length: 400 mm (W100) - Made of: Tyvek™, Easy-Peel film - 1 pouch per cycle, 120 pouches per box STERILIZATION POUCH FOR CHAMBER MODE Tyvek™...
Page 60 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. B3. Dedicated trays Name Descriptions/Specifications Fig. Dedicated vacuum tray optimized for high vacuum sterilization for STERPACK™ STERPACK™ - Size: 195 mm (W) x 80 mm (D) × 30 mm (H) Tray - Weight: 0.15 kg - Made of: Aluminum - For STERPACK™...
Page 61 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. B4. Accessories Name Descriptions/Specifications Fig. Cart with locking wheels - Size: 483 mm (W) × 660 mm (D) × 603 mm (H) Cart - Weight: 37 kg - Made of: Stainless steel External thermal transfer printer - Size: 120 mm (W) ×...
Page 62 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Biological indicators to determine whether or not the sterilization cycle is successful - Size: Tube 50.4 mm (H) x Φ8.5 mm / Cap 16.4 mm (H) x Φ10.5 Biological Indicators (BI) - Packing unit: 50 EA/box...
Page 63 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Attachment C. Product Specifications C1. General Information (1) Product Name: Low Temperature Plasma Sterilizer (2) Model: STERLINK™ FPS-15s Plus (3) Manufacturer Company Name Plasmapp Add. (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea...
Page 64 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. (8) Distributor in Europe Company Name MedNet GmbH Add. Borkstraße 10, 48163 Münster, Germany Phone +49 (0) 251 322 66-61 +49 (0) 251 322 66-22 Website http://www.mednet-eurep.com (9) Purpose: Plasma Sterilization of Medical Instruments at Low Temperature (10) Label sticker: It should be attached at the back of the sterilizer (refer to the following Fig.)
Page 65 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. Specification 3. FPS-15s Plus (FDA, SPU) STERLINK™ FPS-15s Plus User Manual...
Page 66 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. C2. Technical specifications Description (Performance and Specifications) Unit Size 433 (W) × 614 (D) × 437 (H) Chamber liter capacity / SC cycle Pouch Mode Sterilization cycle (STERPACK™) Full cycle / SC cycle Min.
Page 67 Rev. 07 (Apr 2022) Plasmapp Co., Ltd. User Manual for STERLINK™ FPS-15s Plus Sterilization System Manufacturer: Plasmapp Co., Ltd. (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea (18151) 372, Dongbu-daero, Osan-si, Gyeonggi-do, Republic of Korea Website: http://plasmapp.com Phone: 1544-0508 Fax: +82-42-716-2116 Distributor in Europe: MedNet GmbH Borkstraße 10, 48163 Münster...

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