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Summary of Contents for Plasmapp STERLINK FPS-15s Plus
- Page 1 User Manual Low Temperature Plasma Sterilizer Plasmapp Co., Ltd. Language: KR □ EN ■ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □ FPS-15s Plus Sterilization System Language: EN STERLINK™...
- Page 2 Plasmapp Co., Ltd. (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea Plasmapp’s Customer Service Center +82-1544-0508 Plasmapp International Customer Support (Contact your local Plasmapp Customer Support Representative) http://plasmapp.com ⓒ 2023 Plasmapp Co., Ltd. All rights reserved. Other products mentioned in this publication are the trademarked by their respective owners.
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Page 3: Table Of Contents
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Table of Contents Chapter 1. Introduction 1.1. How to Use This Manual 1.2. Contact Us 1.3. Contact Information Chapter 2. Safety Information 2.1. Personal Safety and First Aid 2.2. Personal Protective Equipment 2.3. - Page 4 Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.4. Mounting Cassette 5.5. Starting the Sterilization Cycle 5.6. Progress and Completion of the Cycle 5.7. Cancellation of the Sterilization Cycle 5.8. Handling Sterilized Loads 5.9. How to Power Off Safely Chapter 6. Access Levels and Administrator Tasks 6.1.
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Page 5: Chapter 1. Introduction
+82-1544-0508 in Korea. Internationally, contact your local Plasmapp customer support representative. You may also visit our website at http://plasmapp.com. -
Page 6: Contact Information
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 1.3. Contact Information 1.3.1. Manufacturer Company Name Plasmapp Add. (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea Phone +82-1544-0508 Website http://plasmapp.com 1.3.2. Customer Service Center Company Name Plasmapp Add. (06611) 59, Seocho-daero 77-gil, Seocho-gu, Seoul, Republic of Korea... -
Page 7: Chapter 2. Safety Information
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. You should be well acquainted with the warnings, cautions, and notes stated in this user manual. -
Page 8: Personal Protective Equipment
Rev. 00 / May. 2023 Plasmapp Co., Ltd. WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC. Ingestion of hydrogen peroxide may be life-threatening. If swallowed, drink plenty of water immediately to dilute. Do not try to induce vomiting. Please consult a doctor immediately if the symptoms are severe or persist. -
Page 9: Warnings, Cautions And Notes
Rev. 00 / May. 2023 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 10 Rev. 00 / May. 2023 Plasmapp Co., Ltd. HAZARDOUS CHEMICAL PRESENT Be sure to wear personal protective equipment HAND CRUSH HAZARD Keep your hands away from the device during the operation ELECTRIC SHOCK HAZARD NO PUSHING NO SITTING NO STEPPING ON SURFACE...
- Page 11 Rev. 00 / May. 2023 Plasmapp Co., Ltd. AUTHORIZED EC REPRESENTATIVE EXPIRY DATE SERIAL NUMBER TEMPERATURE LIMIT HUMIDITY LIMIT CAUTION THE EQUIPMENT SHOULD NOT BE DISPOSED OF IN THE NORMAL WASTE STREAM UNIQUE DEVICE IDENTIFIER BATCH CODE KEEP AWAY FROM SUNLIGHT DO NOT RE-USE STERLINK™...
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Page 12: Msds
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 2.5. MSDS For more information, contact Plasmapp or your local Plasmapp customer support representative. STERLINK™ FPS-15s Plus User Manual... -
Page 13: Chapter 3. Overview Of The Sterilizer
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Chapter 3. Overview of the Sterilizer 3.1. Intended Use 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. -
Page 14: Sterilization Cycle
, including lumens, under worst-case conditions. For additional technical information related to validation, please contact Plasmapp or your local Plasmapp Customer Support Representative. 3.3. Sterilization Cycle The STERLINK™ FPS-15s Plus Sterilization System is designed to operate in chamber mode, which... -
Page 15: Sterilizer Systems And Accessories
Rev. 00 / May. 2023 Plasmapp Co., Ltd. ▪ Plasma Purification: In this process, the used sterilant is removed, creating a vacuum in the chamber of the sterilizer. The removed sterilant is purified through plasma treatment to ensure user safety. - Page 16 Rev. 00 / May. 2023 Plasmapp Co., Ltd. STERLINK™ FPS-15s Plus Fig. 3.2 Sterilization System STERLINK™ FPS-15s Plus Fig. 3.3 dedicated power cable The STERLINK™ FPS-15s Plus Sterilization System provides an optional label printer that allows a user to print a report that summarizes sterilization information. To help a user manage the history with ease, this label printer prints a sticker type report.
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Page 17: Sterilant Cassette
Rev. 00 / May. 2023 Plasmapp Co., Ltd. WARNING! USE OF PRINTER & CABLE. Use of accessories, cables other than those specified or provided by the manufacturer of this equipment could result in decreased electromagnetic compatibility of this equipment and result in improper operation. - Page 18 Rev. 00 / May. 2023 Plasmapp Co., Ltd. CAUTION! CHECK EXPIRY DATE. ™ Before using the sterilant cassettes (STERLOAD ), check the expiry date. If the cassette is expired, do not use. Dispose of the expired cassette and use an available unexpired sterilant cassette.
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Page 19: Chapter 4. Preparation Of Medical Devices
FPS-15s Plus sterilization process will affect the item(s). 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. WARNING! BREACH OF WARRANTY. -
Page 20: Items Applicable To The Sterilizer
Do not sterilize the items or materials that are not permitted for use in this sterilizer. To determine what items can be sterilized with the STERLINK™ FPS-15s Plus Sterilizer System, refer to the medical device manufacturer's instructions or contact your local Plasmapp customer support representative. -
Page 21: Material Compatibility
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 4.4. Material compatibility As a reference, the result of material compatibility test is described below. Type Cosmetic change Physical properties Metal Aluminium 5052 None No change materials Aluminium 6061 None No change... -
Page 22: Packing And Loading
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 23 Rev. 00 / May. 2023 Plasmapp Co., Ltd. 4.7.2. Loading STERLINK™ FPS-15s Plus e cassette should be correctly mounted on the loading block of the Sterilization System. For the Chamber Mode, it is recommended to load the cassette (STERLOAD™) first, and then put the packaged medical instrument into the chamber.
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Page 24: Chapter 5. Operation
Rev. 00 / May. 2023 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 25 Rev. 00 / May. 2023 Plasmapp Co., Ltd. WARNING! DISPOSAL OF HYDROGEN PEROXIDE. Hydrogen peroxide is designated as a dangerous and hazardous medical waste by the American Environment Protection Association and should be disposed of in accordance with applicable local regulations. (U.S. Waste Disposal Regulations: U.S. EPA 40 CFR 262) CAUTION! USE MANUFACTURER SUPPLIED POWER CORD ONLY.
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Page 26: Start-Up And Preheating
Rev. 00 / May. 2023 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 27: Preparations For Loading
Rev. 00 / May. 2023 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 28: Mounting Cassette
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.4. Mounting Cassette STERLINK™ FPS-15s Plus sterilizer has one operating mode which is operated by using the STERLOAD™ cassette. Mount the Sterilization Cassette on the loading block as shown in the figure below. -
Page 29: Starting The Sterilization Cycle
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.5. Starting the Sterilization Cycle 1. Place the medical instruments to be sterilized properly in the chamber, and confirm that the door is closed. 2. Press the ‘ ’ icon to start the sterilization cycle. - Page 30 Rev. 00 / May. 2023 Plasmapp Co., Ltd. gloves when handling used cassettes. WARNING! POSSIBLE NON-STERILE DEVICE. Improper loading of the cassette may result in either a non-sterile device or cycle cancellation. The cassette should be precisely loaded on the cassette loading block of the sterilizer and properly locked.
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Page 31: Progress And Completion Of The Cycle
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.6. Progress and Completion of the Cycle Upon the completion of the sterilization cycle, the sterilization displays the cycle information such as the sterilization date, time, and the result of the mode. Click “confirm” button to return to “main”... -
Page 32: Cancellation Of The Sterilization Cycle
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.7. Cancellation of the Sterilization Cycle Fig. 5.6 Screen for cancellation of sterilization cycle Name Description STOP This icon is for cancelling the cycle This icon is for confirming the cancellation Cancel... -
Page 33: Handling Sterilized Loads
Rev. 00 / May. 2023 Plasmapp Co., Ltd. WARNING! POSSIBLE NON-STERILE DEVICE. Cycle cancellation may result in a non-sterile device and requires a new sterilization cycle to be performed after placing the device(s) in new packaging material. CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT. - Page 34 Rev. 00 / May. 2023 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 35 Rev. 00 / May. 2023 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...
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Page 36: How To Power Off Safely
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 5.9. How to Power Off Safely In order to power the sterilizer off, turn off the main power switch on the backside after checking the chamber vented to the atmospheric pressure. If the chamber vented properly, the door could be opened. -
Page 37: Chapter 6. Access Levels And Administrator Tasks
▪ 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 STERLINK™ FPS-15s Plus User Manual... -
Page 38: Additional Utilities Menu
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 6.3. Additional Utilities Menu The additional utilities menu of ‘Configuration’ is only available to administrators, or users with service level access. The additional utility menus allow administrators to configure time settings, sterilization system settings, and diagnostic tests. - Page 39 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 seconds. If the problems persist, please contact Plasmapp or your local Plasmapp customer support representative. STERLINK™ FPS-15s Plus User Manual...
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Page 40: Chapter 7. Reports And Data
Rev. 00 / May. 2023 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 of the cycle date, time, process mode, and the result of the sterilization cycle. - Page 41 Rev. 00 / May. 2023 Plasmapp Co., Ltd. Fig. 7.2 Short format report for passed and failed cycle Printer paper used is thermal transfer paper that is prone to fade due to exposure to sunlight or high temperatures. The shelf life of the printer paper is approximately 5 years. For long-term records storage, it is advised that a copy or scan of the report be made.
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Page 42: Data
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Fig. 7.3 Long-format report for passed and failed cycle 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 43: Chapter 8. Maintenance
Rev. 00 / May. 2023 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. - Page 44 Rev. 00 / May. 2023 Plasmapp Co., Ltd. ▪ When a user attempt to clean the chamber, door, or interior surface, the user must wear gloves and follow the guidelines. ▪ Failure to follow the guidelines may result in damage to the sterilizer and may void the warranty.
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Page 45: Sterilization Cassette
Rev. 00 / May. 2023 Plasmapp Co., Ltd. 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. Sterilization Cassette Hydrogen peroxide (formula: H ) contained in the cassettes of STERLOAD™... - Page 46 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.
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Page 47: Chapter 9. Troubleshooting
In many causes you can take remedial actions to correct the source of the problem and thereby return the sterilizer to normal operation. If you are unable to identify the cause and solve the problem, please contact Plasmapp or your local Plasmapp customer support representative. -
Page 48: User Errors
The STERLINK™ FPS-15s Plus Sterilization System is designed to show intuitive figures of likely causes for user errors and provide warning messages. Therefore, the user should be able to identify and understand such errors. If the problem persists, please contact Plasmapp or your local Plasmapp Customer Support Representative. -
Page 49: Self-Diagnosis Function
Rev. 00 / May. 2023 Plasmapp Co., Ltd. STERLINK™ FPS-15s Plus sterilization system. If the problems persist, please contact Plasmapp or your local Plasmapp customer support representative. WARNING! POSSIBLE NON-STERILE DEVICE. Any error may result in a non-sterile medical device, and it requires to restart a new sterilization cycle with rewrapping using new packaging material. - Page 50 Rev. 00 / May. 2023 Plasmapp Co., Ltd. When the barcode of STERLOAD™ is invalid When the barcode recognition of STERLOAD™ is not good Poor formation of a vacuum (standard) Poor injection of the sterilant Poor diffusion of the sterilant...
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Page 51: Attachment A. Warranty
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 52: Attachment B. Cassettes, Consumables, And Accessories
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Attachment B. Cassettes, Consumables, and Accessories B1. Sterilant Cassettes Name Descriptions/Specifications Figure Cassette containing the sterilant for the CHAMBER Mode. Store at room temperature between 15-30℃ (59-86℉). Keep away from sunlight. STERLOAD™... - Page 53 Rev. 00 / May. 2023 Plasmapp Co., Ltd. B3. Monitoring system Name Descriptions/Specifications Figure ® Biological indicator for sterilization cycle monitor (BT96, Terragene Self-Contained - Spore: Geobacillus stearothermophilus ATCC 7953 Biological - Population: ≥ 10 Indicator - Spore carrier: Polyethylene fibers...
- Page 54 Rev. 00 / May. 2023 Plasmapp Co., Ltd. B4. Accessories Name Descriptions/Specifications Figure 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) ×...
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Page 55: Attachment C. Product Specifications
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Attachment C. Product Specifications C1. General Information (1) Product Name: Low Temperature Plasma Sterilizer (2) Model: FPS-15s Plus (3) Life Cycle: 15 years (4) Manufacturer Company Name Plasmapp Address (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea... - Page 56 Rev. 00 / May. 2023 Plasmapp Co., Ltd. C2. Technical specifications Description (Performance and Specifications) Unit Size 433 (W) × 614 (D) × 437 (H) Chamber capacity liter / SC cycle Chamber Mode Sterilization cycle (STERLOAD™) Full cycle Sterilization Sterilant: Hydrogen peroxide (concentration: 58-59.5%)
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Page 57: Attachment D. Electromagnetic Compatibility Information
Rev. 00 / May. 2023 Plasmapp Co., Ltd. Attachment D. Electromagnetic Compatibility Information Phenomenon Basic EMC standard Test level or test method /requirement Mains terminal CISPR 11 Group1, Class A disturbance voltage EN 55011 Radiated disturbance CISPR 11 Group1, Class A... - Page 58 Rev. 00 / May. 2023 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 Website: http://plasmapp.com Phone: +82-1544-0508 - This user manual is not for sale. -...
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