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Summary of Contents for Plasmapp STERLINK mini
- Page 1 Language: KR □ EN ■ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □ JA □ PT □ STERLINK mini Sterilization System Document Number : PLA-UM-SMU-001...
- 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) www.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
4.2. Items Applicable to the Sterilizer 4.3. Things that Cannot Be Processed by the Sterilization System 4.4. Material compatibility 4.5. Instructions for Preparing the Items to Be Sterilized 4.6. Cleaning, Rinsing, and Drying 4.7. Packaging and loading STERLINK mini User Manual... - Page 4 7.2. Data CHAPTER 8. MAINTENANCE 8.1. Manual maintenance 8.1.1. Cleaning the exterior/interior of the sterilizer 8.1.2. Replacing the label-printer paper 8.1.3. Routine sterilizer maintenance 8.2. Sterilant cassettes 8.3. Shipping, Long-Term Shutdown, and Disposal of the Sterilizer STERLINK mini User Manual...
- Page 5 Rev. 02 (May 2023) Plasmapp Co., Ltd. CHAPTER 9. TROUBLESHOOTING 9.1. User errors 9.2. Self-Diagnosis Function ATTACHMENT A. WARRANTY ATTACHMENT B. CASSETTES, CONSUMABLES, AND ACCESSORIES ATTACHMENT C. PRODUCT SPECIFICATIONS STERLINK mini User Manual...
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Page 6: Chapter 1. Introduction
1.2. Contact Us If you have any questions about the operation of the STERLINK mini Sterilization System or would like to know whether certain types of medical devices are sterilized safely, please contact our customer service center at +82-1544-0508 in Korea. -
Page 7: Contact Information
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 Phone +82-1544-0508 e-mail cs@plasmapp.com STERLINK mini User Manual... -
Page 8: 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 9: Personal Protective Equipment
CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT. Wear latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or error occurrence. Hydrogen peroxide liquid may be present on the load or in the chamber. STERLINK mini User Manual... -
Page 10: Warnings, Cautions And Notes
Cautions indicate events or conditions that can result in severe damage to the equipment. Note are accompanied by a check mark and are printed in italics. Notes highlight specific information about the proper use and maintenance of the STERLINK mini Sterilizer System. 2.4. Symbols REFER TO INSTRUCTION MANUAL... - Page 11 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 POWER ON POWER OFF PROPECTIVE EARTH (GROUND) MANUFACTURER DATE OF MANUFACTURING STERLINK mini User Manual...
- Page 12 Plasmapp Co., Ltd. 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 mini User Manual...
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Page 13: Chapter 3. Sterilizer Overview
Chapter 3. Overview of the Sterilizer 3.1. Intended Use The STERLINK mini sterilizer system is a low temperature sterilizer using sterilant of hydrogen peroxide to inactivate microorganisms for a broad range of metal and nonmetal medical devices. This sterilizer offers an effective, safe, fast, economical, easy–to-use, reliable, and flexible sterilization method. -
Page 14: Sterilization Cycle
Plasmapp or your local Plasmapp Customer Support Representative. 3.3. Sterilization cycle The STERLINK mini sterilizer is designed to be operated in chamber modes, which is a combined cycle of the Smart Ready (SR™), Sterilization and Smart Complete (SC™) process. The sterilizer is designed to operate only with the sterilant cassettes of STERLOAD™... -
Page 15: Sterilizer Systems And Accessories
The steps in the Phase 1 are repeated. 3.4. Sterilizer Systems and Accessories Optional accessories are available for use with the STERLINK mini Sterilization System. The following figure shows the sterilizer system including the sterilizer cart and label-printer accessories. Fig. 3.1 STERLINK mini sterilizer... - Page 16 Rev. 02 (May 2023) Plasmapp Co., Ltd. Fig. 3.2 Main sterilizer of STERLINK mini Fig. 3.3 Pump module of STERLINK mini STERLINK mini Fig. 3.4 dedicated power cable STERLINK mini User Manual...
- Page 17 This device supplies power to the power socket on the rear of the main sterilizer using the dedicated power connection line for STERLINK mini, and provides protection against electric shock by connecting the grounding conductor to ground. The power of the pump unit is supplied through the power connection line fixed on the rear of the main sterilizer.
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Page 18: Sterilant Cassettes
3.5. Sterilant cassettes The STERLINK mini system has one mode (CHAMBER mode) which is automatically initiated by the sterilizer according to the barcoded printed on the STERLOAD™ mini sterilant cassettes. - Page 19 CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT. Wear latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or error occurrence. Hydrogen peroxide liquid may be present on the load or in the chamber. STERLINK mini User Manual...
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Page 20: Chapter 4. Preparation Of Medical Devices
Chapter 4. Preparation of Medical Devices 4.1. Indications for Use The STERLINK mini sterilizer with STERLOAD™ mini is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. -
Page 21: Items Applicable To The Sterilizer
Plasmapp Co., Ltd. 4.2. Items Applicable to the Sterilizer The STERLINK mini Sterilization System is classified as ‘Class II’ in accordance with section 513(a) of the Federal Food, Drug, and Cosmetic Act and is intended to be used to sterilize medical instruments, including surgical instruments. -
Page 22: Material Compatibility
4.5. Instructions for Preparing the Items to Be Sterilized All items should be cleaned, rinsed, and thoroughly dried before being put into the STERLINK mini sterilizer. If a medical device with too much moisture is put into the sterilizer, the cycle may be automatically canceled. -
Page 23: Packaging And 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 “4.3 Items not to be processed” section. - Page 24 CAUTION! INSERT CI (CHEMICAL INDICATOR). Insert the CI in the packaging together with the product. After the sterilization cycle is completed, verify that the product is working properly, and the CI color has changed color accordingly. STERLINK mini User Manual...
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Page 25: Chapter 5. Operation
▪ When restarting a sterilizer that has not been used for a long time, a user should contact the manufacturer to get appropriate instructions. ▪ This equipment can only be operated by people who have been trained by the manufacturer or a manufacturer-delegated company. STERLINK mini User Manual... -
Page 26: Start-Up And Preheating
CAUTION! USE MANUFACTURER SUPPLIED POWER CORD ONLY. To avoid risk of equipment malfunction or electrical shock, use the power cord supp lied by the manufacturer with the STERLINK mini sterilizer only. WARNING! DO NOT MODIFY THIS EQUIPMENT. No modification of this equipment is allowed. -
Page 27: Preparations For Loading
While the sterilizer is preheated, you can prepare the loads. Mode Item description Total mass of the items should be less than 1.54 lbs (0.7 kg). CHAMBER (A maximum of five medical devices with lumen structure can be included.) STERLINK mini User Manual... -
Page 28: Cassette Loading
5.4. Cassette loading The STERLINK mini sterilizer has a mode which is operated by using the cassette of the STERLOAD™ mini. Place the cassette in the loading block as depicted in the following figure. “This side up”... - Page 29 Rev. 02 (May 2023) Plasmapp Co., Ltd. STERLINK mini User Manual...
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Page 30: Starting The Sterilization Cycle
▪ If a cassette is mounted incorrectly, an error occurs in barcode recognition, and the cycle will be canceled. ▪ If the chamber door is not tightly closed, the cycle will be cancelled. ▪ The cancellation of a cycle does not guarantee a Sterility Assurance Level, and a user may be STERLINK mini User Manual... - Page 31 CAUTION! HYDROGEN PEROXIDE MAY BE PRESENT. Wear latex, PVC (vinyl), or nitrile gloves whenever handling a load after a cycle cancellation or error occurrence. Hydrogen peroxide liquid may be present on the load or in the chamber. STERLINK mini User Manual...
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Page 32: Progress And Completion Of The Cycle
Displays the result of the sterilization cycle Confirm Clicks on “Confirm” button, the screen moves to ready state Clicks on “Print” button, the label printer will print out the summary Print of the sterilization cycle information STERLINK mini User Manual... -
Page 33: Cancellation Of The Sterilization Cycle
Aborting cancels the cycle. Door handling This section emphasizes that the user should not handle it during the caution stopping process. When the sterilization cycle cancellation is complete, the screen Home returns to the ready state. STERLINK mini User Manual... -
Page 34: Handling Sterilized Loads
Then repackage and reprocess the load. 5.8.2. Processing self-contained biological indicator Remove the biological indicator from the load /or PCD and process it according to its Instruction for use. Refer to the biological indicator flow chart on the following pages. STERLINK mini User Manual... - Page 35 Rev. 02 (May 2023) Plasmapp Co., Ltd. Cycle Completion Procedures STERLINK mini User Manual...
- Page 36 Rev. 02 (May 2023) Plasmapp Co., Ltd. STERLINK mini User Manual...
- Page 37 Rev. 02 (May 2023) Plasmapp Co., Ltd. Procedures to Validate the Sterilization Cycles by Using Biological Indicators STERLINK mini User Manual...
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Page 38: Chapter 6. Access Levels And Administrator Tasks
6.2. Access levels The STERLINK mini sterilizer can be configured to require that the users enter a valid password in order to control the system configuration. There are three levels of access available. Each is associated with a different subset of permitted operations. -
Page 39: Additional Utilities Menu
If the chamber is not opened due to vacuum, the emergency vent button can E-Open be used to forced vent. It shows the usage history of the equipment. Up to 80 usage histories are History stored. STERLINK mini User Manual... - Page 40 When it occurs, this “E-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 mini User Manual...
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Page 41: Chapter 7. Reports And Data
Chapter 7. Reports and Data 7.1. Reports Upon completion of the sterilization cycle, the STERLINK mini 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 42 The long-format report is useful for detailed cycle quality control and contains valuable diagnostics information for customer service. The report includes the detailed information about the sterilization cycle, and operation parameters. Examples of the long-format report are illustrated in the following figure. STERLINK mini User Manual...
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Page 43: Data
Fig. 7.3 Long-format report for passed and failed cycle 7.2. Data The STERLINK mini 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 44: Chapter 8. Maintenance
Plasmapp Co., Ltd. Chapter 8. Maintenance The STERLINK mini 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 plus sterilization system. -
Page 45: Replacing The Label-Printer Paper
1. While holding the body of the printer, press and open the front cover. 2. Press both sides of the middle cover to open it, revealing the label-printer roll. 3. Remove by pulling out the roll. 4. Insert new label-printer roll and close the middle cover and front cover. STERLINK mini User Manual... -
Page 46: Routine Sterilizer Maintenance
8.3. Shipping, Long-Term Shutdown, and Disposal of the Sterilizer When the STERLINK mini sterilizer system is reinstalled from initial place to the another, the system shall be moved by the authorized technicians. If there is no continuous sterilization cycle, it is required to turn off the power switch of the sterilizer and pull out the power cord from the power outlet with following storage condition. - Page 47 Rev. 02 (May 2023) Plasmapp Co., Ltd. event that it is necessary to dispose of the system contact Plasmapp or the local Plasmapp customer support representative for additional information. CAUTION! DO NOT CARRY ALONE. Because this product is heavy, it should be carried and moved by two or more people.
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Page 48: Chapter 9. Troubleshooting
The STERLINK mini sterilization system is designed to provide alarm messages with the intuitive figures representing the predictable source for the 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. -
Page 49: Self-Diagnosis Function
9.2. Self-Diagnosis Function Problems can be caused by a malfunction of the STERLINK mini Sterilization System, including user errors, sterilization cassettes-related errors, and other system errors described above. If you click the “History”... - Page 50 The door to the chamber does not close properly. Using re-used STERLOAD™ mini. Using expired STERLOAD™ mini. The barcode validity of STERLOAD™ mini is flawed. Poor barcode recognition on STERLOAD™ mini. Inadequate initial vacuum formation. Sterilant injection is inadequate. Sterilant diffusion is inadequate. STERLINK mini User Manual...
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Page 51: Attachment A. Warranty
Plasmapp Co., Ltd. Attachment A. Warranty 1. The manufacturer of Plasmapp Co., Ltd. warrants the product of STERLINK mini sterilizer to be free from defects in materials and workmanship for a period of one year from the delivery date. 2. For any defects found in manufacturing or in normal use, the warranty can be applied. To be eligible for the warranty, the defects should be identified and notified to the manufacturer. -
Page 52: Attachment B. Cassettes, Consumables, And Accessories
B1. Sterilant cassettes Name Description / Specifications Figure Cassette containing sterilant for Chamber mode - Material: Flame retardant ABS STERLOAD™ mini - Sterilant: Hydrogen peroxide (concentration: 58 – 59.5%) - 1 cycle per cassette, 30 cassettes per box STERLINK mini User Manual... - Page 53 Device sterile packaging roll for Chamber mode - Pouch width: 400 mm Tyvek ® roll - Total length: 100 M (FR400100) - Material: Tyvek ®, and PET/LLDPE film - Customized cut per cycles, 100 M per box STERLINK mini User Manual...
- Page 54 - Tape width: 20 mm - Length: 50 M (CI tape)) Chemical ® Chemical Indicator for sterilization cycle monitor (CD42, Terragene Indicator strip - Size: 18mm × 105 mm - Packaging: 250 strips per case (CI strip) STERLINK mini User Manual...
- Page 55 - Size: 120 mm × 102 mm × 146 mm Label-Printer - Weight: 0.5 kg - Thermal paper width: 56 mm Label sticker roll for label-printer - Roll width: 56 mm Label Sticker Roll - Roll length: 49 labels - 6 rolls per box STERLINK mini User Manual...
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Page 56: Attachment C. Product Specifications
Rev. 02 (May 2023) Plasmapp Co., Ltd. Attachment C. Product Specifications C1. General information (1) Product name: Low temperature plasma sterilizer (2) Model: STERLINK mini (3) Manufacturer Company Name Plasmapp Address (41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea Phone... - Page 57 Plasma discharge treatment (Low frequency) 153.1 (W) x 85.6 (H) Size Display Resolution 800 x 480 pixel Port IEC-320 C14, RJ-45, USB type A, USB type B, cable connector Rated power 100-125 VAC, 10 A Electrical characteristic Rated frequency 50/60 STERLINK mini User Manual...
- Page 58 Rev. 02 (May 2023) Plasmapp Co., Ltd. Attachment D. Electromagnetic Compatibility Information STERLINK mini User Manual...
- Page 59 Rev. 02 (May 2023) Plasmapp Co., Ltd. User Manual for STERLINK mini 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. - STERLINK mini User Manual...
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