Plasmapp Sterlink FPS-15s Plus User Manual
  1. Manuals
  2. Brands
  3. Plasmapp Manuals
  4. Laboratory Equipment
  5. Sterlink FPS-15s Plus
  6. User manual

Plasmapp Sterlink FPS-15s Plus User Manual

Low-temperature plasma sterilizer
Hide thumbs Also See for Sterlink FPS-15s Plus:
Table of Contents

Advertisement

Quick Links

+
FPS-15s Plus (FPS-15s
)
User Manual
Low-temperature plasma sterilizer
by Plasmapp Co., Ltd.
Language: EN
®
STERLINK
FPS-15s Plus Plus User Manual

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the Sterlink FPS-15s Plus and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Plasmapp Sterlink FPS-15s Plus

Summary of Contents for Plasmapp Sterlink FPS-15s Plus

  • Page 1 FPS-15s Plus (FPS-15s User Manual Low-temperature plasma sterilizer by Plasmapp Co., Ltd. Language: EN ® STERLINK FPS-15s Plus Plus User Manual...
  • Page 2 Borkstraße 10, 48163 Münster, Germany Plasmapp Customer Center +82-42-716-2115 Plasmapp International Customer Support (Call your local Plasmapp Customer Support Representative) http://www.plasmapp.co.kr ⓒ2019 Plasmapp Co., Ltd. All rights reserved. Other products mentioned in this publication are trademarked by their respective owners. Reproduction, ®...
  • Page 3 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. adaptation, or translation of this publication without prior written permission is prohibited. Printed in Republic of Korea. ® STERLINK FPS-15s Plus User Manual...
  • Page 4 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. REVISION HISTORY Revision No. Description of changes Date Approver Initial release 2017.10.12 Amended by reflection of Risk 2018.06.30 management, usability Amended by modification for changing 2018.07.27 software GUI. Amended by modification for adding POUCH Plus mode and changing of 2019.01.11...

  • Page 5: Table Of Contents

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Contents 1. Introduction 1.1. How to use this User manual 1.2. If you have questions 1.3. Contact information 2. Safety information 2.1. Personal safety and first aid 2.2. Personal protective equipment 2.3. Warning, cautions, and notes 2.4.
  • Page 6 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 4.6.1. Instrument tray 4.6.2. Tray mats 4.6.3. Packaging 4.6.4. Loading 5. Operation 5.1. Before you start 5.2. Start and warm-up 5.3. Preparing the load 5.4. Cassette Loading 5.5. Starting sterilization cycle 5.6. Cycle in progress and completed 5.7.
  • Page 7 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 8. Maintenance 8.1. Manual maintenance 8.1.1. Cleaning the sterilizer exterior and interior chamber 8.1.2. Replacing label-printer paper 8.1.3. Routine sterilizer maintenance 8.2. Sterilant cassettes 8.3. Moving, long term stop and disposal of the sterilizer 9.

  • Page 8: Introduction

    FPS-15s Plus sterilizer or what kind of items may be safely sterilized, please call our customer service center at +82-42-716-2115 in Korea. Internationally, call your local Plasmapp customer support representative. You may also wish to visit our website at http://www.plasmapp.co.kr.

  • Page 9: Contact Information

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 1.3. Contact information 1.3.1. Manufacturer Company Plasmapp Co., Ltd. Address 83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea +82-42-716-2115 +82-42-716-2116 Website http://www.plasmapp.co.kr 1.3.2. Customer care center Company Plasmapp Co., Ltd. Address 83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea...

  • Page 10: Safety Information

    Plasmapp Co., Ltd. Chapter 2. Safety information Your safety is the primary concern of Plasmapp Co., Ltd. and this chapter provides information on safely using the Sterilizer system. You must read and understand the safety information and instruction given in this chapter before operating the sterilizer.

  • Page 11: Personal Protective Equipment

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. WARNING! RISK OF SKIN INJURY. Direct contact between the skin and hydrogen peroxide can cause severe irritation. If the contact occurs, immediately flush skin with large amounts of water. If symptoms are severe or persist, consult a physician immediately.

  • Page 12: Warning, Cautions, And Notes

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 2.3. Warnings, cautions, and notes Warnings and cautions are accompanied by symbols surrounded by a triangle and are printed in the text in boldface italics. Warnings indicate events or conditions that can result in serious injury or death.

  • Page 13: Sterilizer Overview

    The devices have been pre-validated to the SAL of 10 based upon worst-case conditions, including lumens within the claim lengths and mated surfaces. If additional technical information concerning validation is needed, please contact Plasmapp or your local Plasmapp customer support representative. ®...

  • Page 14: Sterilization Cycle

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 3.3. Sterilization cycle The STERLINK ® FPS-15s Plus sterilizer is designed to be operated at two different modes, and each mode is the combined cycle of the Smart Ready (SR ), Sterilization and Smart Complete ) process.
  • Page 15 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Sterilization process - Phase 1 ∎ Injection: The hydrogen peroxide is transferred from the cassette into the vaporizer and chamber of pouch. Specially in the Pouch mode, the injection is done directly in the pouch to maximize the efficiency of sterilization, quick sterilization process is possible within 10 minutes.

  • Page 16: Sterilizer System And Accessories

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 3.4. Sterilizer system and accessories The STERLINK ® FPS-15s Plus sterilization system has accessories of the sterilizer cart and label-printer. The following figure shows the complete sterilizer system including the accessories. Sterilizer...
  • Page 17 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Figure 3.2 STERLINK ® FPS-15s Plus sterilizer The printer is designed to be connected to the USB print connector on the rear side of the sterilizer. For the detailed information about the report, please refer to the Chapter 7 featuring "Reports and Data”.

  • Page 18: Sterilant Cassettes

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 3.5. Sterilant cassettes The STERLINK ® FPS-15s Plus system has three different modes (POUCH, POUCH Plus and CHAMBER mode) which are automatically initiated by using the barcoded printed on the ® ®...
  • Page 19 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Barcode and date of manufacture Figure 3.6 Sterilant cassette of STERLOAD ® Each cassette has two cells of sterilant which contain precisely measured amounts of hydrogen peroxide solution, and the two cells are used for repeating the same sterilization phases for one sterilization cycle.

  • Page 20: Load Preparation

    FPS-15s Plus sterilization process will affect the items. If you have questions, or if you are in doubt about the materials in your device, contact the medical device manufacturer or your local Plasmapp customer support representative for more information. CAUTION! RISK OF WARRANTY VIOLATION.

  • Page 21: What Can Be Sterilized

    Do not attempt to sterilize items or materials that do not comply with the guidelines specified in this User manual. Consult the medical device manufacturer's instructions or call your local Plasmapp customer support representative to determine whether an ® item can be sterilized by the STERLINK FPS-15s Plus sterilization system.

  • Page 22: Guidelines For Preparing Items To Be Sterilized

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. ∎ Items made of materials that contain cellulose, such as cotton, paper or cardboard, linens, buck towels, gauze sponges, or any item containing wood pulp. ∎ Paper instrument count sheets or lot stickers.

  • Page 23: Packaging And Loading

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. ∎ Dry all items thoroughly. An acceptable method for drying is to blow compressed gas through the lumen until no moisture exits the distal end of the device. Please ensure that any method used to dry the devices is in accordance with the manufacturer's instructions for use or contact the device manufacturer to obtain appropriate and safe procedures.

  • Page 24: Loading

    ∎ Do not use paper pouches or sterilization wraps containing cellulose or cotton. ∎ Do not use any wraps or packaging that are not approved by Plasmapp Co., Ltd. or materials on the "Items not to be processed" section.
  • Page 25 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. CAUTION! BE CAREFUL, MAY BE CHAMBER HOT! The temperature of the chamber may be hot. Wear protective gear and be careful when working inside the chamber and be careful of burns. ®...

  • Page 26: Operation

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Chapter 5. Operation 5.1. Before you start ® Each time you use the STERLINK FPS-15s Plus sterilizer, follow the instructions provided in the chapter 4 "Load preparation." It is the operator's responsibility to be familiar with the load preparation and safety information provided in this User manual.

  • Page 27: Start And Warm-Up

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.2. Start and warm-up 1. Turn on the main power switch which is located at the rear side of the sterilizer. 2. Close the door during preheating process for warming up. The warm-up process can take up to 40 minutes.

  • Page 28: Preparing The Load

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.3. Preparing the load Confirming that sterilizing conditions were achieved during a sterilization cycle is one of important part of the sterilization process. Biological indicators are one way to ensure that your sterilizer is operating correctly.

  • Page 29: Cassette Loading

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.4. Cassette loading ® The STERLINK FPS-15s Plus sterilizer has three different modes which are operated by using the cassette of the STERPACK ® , STERPACK ® Plus and STERLOAD ® . Place the cassette in the loading block as depicted in the following figure.

  • Page 30: Starting Sterilization Cycle

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.5. Starting sterilization cycle 1. Check whether the door is closed when the load has been properly placed in the chamber. 2. Touch "Sterilize" icon to start sterilization cycle. 3. The sterilizer automatically scans the barcode printed on the cassette to check validity of the loaded cassette and determine the operation mode.
  • Page 31 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Notes. ∎ If the cassette is reused or expired one, it results in cycle cancellation. ∎ Improper loading of the cassette may result in scanning error, and the cycle will be canceled.

  • Page 32: Cycle In Progress And Completed

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.6. Cycle in progress and completed In the SR process, the drying, heating and measuring the residual water are included in the load condition. Figure 5.4 GUIs for the drying and sterilization process...
  • Page 33 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Figure 5.5 GUIs for the SC process and completed summary stage Number Name Description status The status image will be blinking during the SC process. Date This section displays the date of the sterilization cycle.

  • Page 34: Cancelling Sterilization Cycle

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.7. Cancelling sterilization cycle There may be occasions when the user needs to cancel a cycle before it is completed. Touch the "STOP" button, and the screen displays a confirmation message. The user have to confirm the cycle cancellation to stop the cancellation process.
  • Page 35 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Number Name Description Caution for door It highlights that door should not be handled by the user during the handling stopping process. Caution for The status image will be blinking during the sterilization process.

  • Page 36: Processing A Sterilized Load

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 5.8. Processing a sterilized load When you confirm the completed cycle, the sterilized load can be processed by inspecting the chemical indicators and by processing the biological indicator. 5.8.1. Inspecting chemical indicator...
  • Page 37 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Cycle completion flowchart ® STERLINK FPS-15s Plus User Manual...
  • Page 38 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Biological indicator processing flowchart ® STERLINK FPS-15s Plus User Manual...

  • Page 39: Access Levels And Supervisor Tasks

    ∎ Run diagnostic tests ∎ Perform Calibration for the sensors ∎ Perform emergency action function ∎ Setup system time Service-level access is only for use by the Plasmapp Customer Service Representatives. ∎ Software update ∎ Modify the process parameters ®...

  • Page 40: Additional Utility Menu

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 6.3. Additional utility menu The Additional utilities menu in the "Configuration" is available to users with Supervisor or Service-level access authorities. The Additional utilities menu allows supervisors to configure the time setting, sterilizer system setting, and diagnostic test.
  • Page 41 When it occurs, this “Door open” can be used to open the door. Note that this key is activating addition venting and it can take about 10 sec. It the problems persist, please contact Plasmapp or your local Plasmapp customer support representative.

  • Page 42: Reports And Files

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Chapter 7. Reports and files 7.1. Reports The cycle report is automatically created and displayed by the STERLINK ® FPS-15s Plus sterilizer when the sterilization cycle is completed. The displayed report summarizes the cycle information of the cycle date, time, process mode and the result of the sterilization cycle.
  • Page 43 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. The information will be printed out by the label-printer when print button is selected by a user, and the label-printer will print out the short-format report that shows the device status, information of sterilization cycle, and cassette information. This short-format report is useful for record keeping purposes and label-print is convenient to provide traceability of sterilized loads.
  • Page 44 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. The history can also be printed out by using the instrument tracking system (ITS ). The cycle information which is available at the history page of the ITS can be printed out in the short or long format depending on user purpose and choice.

  • Page 45: Data

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. 7.2. Data The STERLINK ® FPS-15s Plus sterilizer can create, store, display, and print the cycle data. When connected to internet, the sterilizer can upload the cycle history files to the ITS server.

  • Page 46: Maintenance

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Chapter 8. Maintenance ® The STERLINK FPS-15s Plus sterilizer is the highest quality sterilizer that performs reliable sterilization cycles. As the sterilizer may be deteriorated by continuous usages, the sterilizer also needs proper maintenance to guarantee user safety and reliable sterilization cycle.
  • Page 47 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. The sterilizer interior chamber can be cleaned with a soft cloth or damp soft cloth with no running water. When cleaning the sterilizer interior chamber, follow the guidelines. 1.Turn off the power of the sterilizer before cleaning the interior chamber.

  • Page 48: Replacing Label-Printer Paper

    8.1.3. Routine sterilizer maintenance The usage level of each registered sterilizer will be indicated in the user registered ITS system. When the usage level suggests for sterilizer maintenance, please contact your local Plasmapp customer support representative. 8.2. Sterilant cassettes ®...

  • Page 49: Moving, Long Term Stop And Disposal Of The Sterilizer

    Disposal of infectious waste and electronic circuit boards are regulated by the U.S. Environment Protection Agency and most international environmental agencies. Please contact Plasmapp or your local Plasmapp customer support representative for additional information.

  • Page 50: Troubleshooting

    Plasmapp customer support representative. If you are unable to identify the cause and solve the problem, please contact Plasmapp or your local Plasmapp customer support representative.

  • Page 51: Software Update

    FPS-15s Plus sterilization system will be automatically updated by the Plasmapp when the user confirms this update. If the system finds a new software version at the server, the following alarm will be popped up when the system is restarted.

  • Page 52: User Errors

    When the user confirms, the error should be checked and understood by the user. If the problems persist, please contact Plasmapp or local Plasmapp customer service representative. Figure 9.3 GUIs for user errors...

  • Page 53: Sterilant Cassette Errors

    The predictable error source is presented with the intuitive figures, and the user should identify the source and confirm. If the problems persist, contact local Plasmapp customer service representative.

  • Page 54: Other System Errors

    Many system errors are incorporated with the problems with the loads, but the STERLINK FPS- 15s Plus sterilization system also can have a problem resulting from a component failure. If the problems persist, contact Plasmapp or local Plasmapp customer service representative. Figure 9.6 GUIs for the system errors Number...
  • Page 55 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. If the power of sterilization system is abnormally shut off during the sterilization process, the following screen will appear. To ensure user safety, the purification process will be active it can take from a few minutes to tens of minutes, after the status will be ready.

  • Page 56: Contact Information

    9.6.1. Manufacturer Company Plasmapp Co., Ltd. Address 83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea +82-42-716-2115 +82-42-716-2116 http://www.plasmapp.co.kr Website 9.6.2. Plasmapp customer service center Company Plasmapp Co., Ltd. Address 83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea +82-42-716-2115 email plasmapp@plasmapp.co.kr Website http://www.plasmapp.co.kr...

  • Page 57: Attachment A. Warranty

    Plasmapp Co., Ltd. Attachment A. Warranty ® 1. The manufacturer of Plasmapp Co., Ltd. warrants the product of STERLINK FPS-15s Plus sterilizer to be free from defects in materials and workmanship for a period of one year from the delivery date.

  • Page 58: Attachment B. Sterilant Cassettes, Consumables, Tray And Accessories

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Attachment B. Sterilant cassettes, Consumables and Accessories B1. Sterilant cassettes Name Description / Specifications Figure Impermeable pouch containing sterilant for POUCH mode - Size: 135 mm × 280 mm - Material: PP/NY STERPACK ®...
  • Page 59 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. B2. Consumables Name Description / Specifications Figure Device sterile packaging pouch for CHAMBER mode - Pouch width: 100 mm Tyvek ® pouch - Total length: 400 mm ® (W100) - Material: Tyvek...
  • Page 60 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. B3. Special tray Name Description / Specifications Figure Chamber Inner Tray - Size: 250 mm× 350 mm× 105 mm Chamber - Weight: 0.4 kg Tray - Material: Aluminium - Product code: P01 ®...
  • Page 61 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. B4. Accessories Name Description / Specifications Figure Cart with locking wheel - Size: 483 mm × 660 mm × 603 mm - Weight: 37 kg Special Cart - Material: Stainless steel - Product code: E01 External thermal printer - Size: 120 mm ×...

  • Page 62: Attachment C. Specifications

    Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. Attachment C. Specifications C1. General information (1) Product name: Low temperature plasma sterilizer ® (2) Model: STERLINK FPS-15s Plus (3) Manufacturer Company Plasmapp Co., Ltd. Address 83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea...
  • Page 63 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. (8) Authorized EC representative Company MedNet GmbH Address Borkstraße 10, 48163 Münster, Germany Website http://www.mednet-eurep.com (9) Intended use: To provide low temperature sterilization for medical devices (10) Label sticker: Attached on the rear side of the sterilizer (see following figure) ®...
  • Page 64 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. C2. Technical specification Description Unit Dimensions 433 (W) × 614 (D) × 437 (H) Effective liter chamber volume / SC Process POUCH mode Sterilization Process Overall Cycle / SC Process Cycle time...
  • Page 65 Rev. 03 / Jan. 2019 Plasmapp Co., Ltd. ® User manual for the STERLINK FPS-15s Plus sterilization system Manufacturer: Plasmapp Co., Ltd. 83, Jukdong-ro, Youseong-gu, Daejeon, 34127 Republic of Korea Website: http://www.plasmapp.co.kr TEL: +82-42-716-2115 FAX: +82-42-716-2116 Authorized EC representative: MedNet GmbH Borkstraße 10, 48163 Münster...

Table of Contents