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Summary of Contents for Plasmapp GC STERLINK mini
- Page 1 Edition, Revision: 01 / Apr. 27. 2023 Language: KR □ EN ■ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □ JA □ PT □ GC STERLINK mini-User Manual Language: EN...
- Page 2 GC STERLINK mini Sterilization System User Manual Plasmapp Co., Ltd. 102, Cheombok-ro, Dong-gu, Daegu, 41061, Republic of Korea Plasmapp International Customer Support (Call your local Plasmapp Customer Support Representative) Plasmapp Customer Center +82-1544-0508 https://plasmapp.com/eng/ ⓒ 2023 Plasmapp Co., Ltd. All rights reserved.
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Page 3: Table Of Contents
4. Load preparation 4.1. Indications for use 4.2. What can be sterilized 4.3. Items not to be processed 4.4. Guidelines for preparing items to be sterilized 4.5. Cleaning, rinsing, and drying 4.6. Packaging and loading GC STERLINK mini - User Manual... - Page 4 7. Reports and files 7.1. Reports 7.2. Data 8. Maintenance 8.1. Manual maintenance 8.2. Sterilant cassettes 8.3. Moving, long term stop and disposal of the sterilizer 9. Trouble shooting 9.1. User errors 9.2. Self-diagnostic function GC STERLINK mini - User Manual...
- Page 5 Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. Attachment A. Warranty Attachment B. Sterilant, consumables, trays and accessories Attachment C. Specifications GC STERLINK mini - User Manual...
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Page 6: Introduction
Chapter 1. Introduction 1.1. How to use this User manual If you are a user or operator of the GC STERLINK mini sterilizer, you must read the “Safety information”, “Load preparation”, and “Operation” chapters prior to operating the sterilizer system. -
Page 7: Contact Information
Plasmapp Co., Ltd. Address 102, Cheombok-ro, Dong-gu, Daegu, 41061, Republic of Korea +82-1544-0508 Website https://plasmapp.com/eng/ 1.3.2. Customer service center Company Plasmapp Co., Ltd. Address 59, Seocho-daero 77-gil, Seocho-gu, Seoul, Republic of Korea +82-1544-0508 Email cs@plasmapp.com GC STERLINK mini - User Manual... -
Page 8: Safety Information
2. Safety information Chapter Your safety is the primary concern of Plasmapp Co., Ltd. This chapter provides information on safely using the GC STERLINK mini sterilizer system. You must read and understand the safety information and instruction given in this chapter before operating the sterilizer. Always pay attention to the warnings, cautions and notes throughout 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. GC STERLINK mini - User Manual... -
Page 10: Warning, 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 GC STERLINK mini sterilizer system. 2.4. Symbols... - Page 11 Keep hands clear while operating ELECTRIC SHOCK HAZARD Danger of electric shock without an electrical safety device NO PUSHING NO SITTING NO STEPPING ON SURFACE POWER ON POWER OFF PROTECTIVE EARTH (GROUND) MANUFACTURER DATE OF MANUFACTUR EXPIRY DATE GC STERLINK mini - User Manual...
- Page 12 SERIAL NUMBER TEMPERATURE LIMIT HUMIDITY LIMIT CONSULT INSTRUCTION FOR USE 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 GC STERLINK mini - User Manual...
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Page 13: Sterilizer Overview
Chapter 3. Sterilizer overview 3.1. Intended use The GC STERLINK mini sterilizer system is a low temperature sterilizer using sterilant of hydrogen peroxide to inactivate microorganisms for the metal and nonmetal medical devices to cover a broad range of surgical instruments. This product is effective, safe, fast, reasonable, easy to use, reliable, and offers a variety of sterilization methods. -
Page 14: Sterilization Cycle
The GC STERLINK mini sterilizer can be used for metal and non-metal medical devices and it can sterilize instruments that have difficult-to-reach (diffusion-restricted) spaces, such as hinges on forceps. - Page 15 STERPACK through the direct connection port which is also used for injection. Sterilization process – Phase 2 The steps in the Phase 1 are repeated. GC STERLINK mini - User Manual...
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Page 16: Sterilizer System And Accessories
Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. 3.4. Sterilizer system and accessories The GC STERLINK mini sterilizer system is composed with the main sterilizer and pump module as shown in the following figure. Figure 3.1 STERLINK mini sterilization system (front) The STERLINK mini sterilization system has a power supply plug (with cord) and a power supply connector on its back and is connected to a grounding conductor for protection against electric shock. - Page 17 Plasmapp Co., Ltd. Figure 3.3 GC STERLINK mini power cable This GC STERLINK mini sterilization system can be used with a sticker type label-printer as an accessory which is for user convenience in managing the history of sterilization cycle information. The printer is designed to be connected to the USB print connector on the rear side of the sterilizer.
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Page 18: Sterilant Cassettes
Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. 3.5. Sterilant cassettes The GC STERLINK mini system has two different modes of POUCH and CHAMBER mode which are automatically initiated by the sterilizer according to the barcoded printed on the sterilant cassettes of STERPACK ™... - 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. GC STERLINK mini - User Manual...
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Page 20: Load Preparation
Chapter 4. Load preparation 4.1. Indications for use The GC STERLINK mini sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. The sterilization cycle is a multiphase sterilization process that utilizes a combination of exposure to hydrogen peroxide vapor and plasma purification to complete the sterilization cycle. -
Page 21: What Can Be Sterilized
4.2. What can be sterilized There are a wide variety of materials and devices that can be sterilized in the GC STERLINK mini sterilizer. As more manufactures complete testing of their products with the sterilizer, the list of compatible items continues to expand. -
Page 22: Guidelines For Preparing Items To Be Sterilized
GC STERLINK Sterilizer. 4.4. Guidelines for preparing items to be sterilized All items must be cleaned, rinsed, and thoroughly dried before being placed in the GC STERLINK mini sterilizer. Loads containing too much moisture may result an automatic cycle cancellation. -
Page 23: Packaging And Loading
4.6.1. Instrument trays Only GC STERLINK mini instrument trays and accessories are recommended for use in the GC STERLINK mini sterilizer. These instrument trays specially designed to allow diffusion of hydrogen peroxide. If you don’t use the vacuum-designed tray in Pouch mode, the sterilization cycle can be cancelled due to the damage of pouch film. - Page 24 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 25 CAUTION! BE CAREFUL, THE CHAMBER MAY BE 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. GC STERLINK mini - User Manual...
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Page 26: Operation
Chapter 5. Operation 5.1. Before you start Each time you use the GC STERLINK mini 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
Time The current configurable time is displayed in Configuration menu. Preheating progress This section displays the present status of preheating. Sterilize The sterilizer starts the sterilization cycle by touching this icon. GC STERLINK mini - User Manual... -
Page 28: Preparing The Load
When you use the sterilant cassettes (STERPACK , STERLOAD mini), check the expiry date. If the date is expired, dispose the cassette, and use new available sterilant cassettes. The use of expired date cassette will occur an error. GC STERLINK mini - User Manual... -
Page 29: Cassette Loading
Hydrogen peroxide liquid may be present on the load or in the chamber. 5.4. Cassette loading The GC STERLINK mini sterilizer has two different modes which are operated by using the cassette of the STERPACK™, STERLOAD™ mini. Place the cassette in the loading block as depicted in the following figure. -
Page 30: Starting Sterilization Cycle
This represents the sterilization mode determined by the barcode. Door This section displays the door status. Progress This section displays the progress of the sterilization process. Stop This icon is for stopping the cycle which is determined by the user. GC 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. GC STERLINK mini - User Manual...
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Page 32: Cycle Completion
When the user clicks on “Confirm” button, the screen moves to ready Confirm state. When the user clicks on “Print” button, the label printer will print out Print the summary of the sterilization cycle information. GC STERLINK mini - User Manual... -
Page 33: Cancelling Sterilization Cycle
This icon is for withdrawing the cancellation. This section displays for removing residual sterilant when the user Aborting cancels the cycle. When the sterilization cycle cancellation is complete, the screen The main screen returns to the ready state. GC STERLINK mini - User Manual... -
Page 34: Processing A Sterilized Load
If the chemical indicators do not exhibit the correct color change, investigate the cause and repackage and reprocess the load. GC STERLINK mini - User Manual... -
Page 35: Sterilant Disposal Cycle
5. When the disposal process begins, the inside of the chamber maintains a vacuum state. User cannot force the door open due to vacuum state of chamber during disposal process. Figure 5.5 GUIs for confirmation of disposal and disposal process screen GC STERLINK mini - User Manual... - Page 36 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. GC STERLINK mini - User Manual...
- Page 37 Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. Cycle completing flowchart GC STERLINK mini - User Manual...
- Page 38 Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. Biological indicator processing flowchart GC STERLINK mini - User Manual...
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Page 39: Access Levels And Supervisor Tasks
6.2. Access levels The GC 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 40: Additional Utility Menu
The Additional utilities menu in the “System configuration menu” 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. Figure 6.1 GUIs for system setting GC STERLINK mini - User Manual... - Page 41 Turn each heater on and off and check the temperature. (Heater) Manual Test Open and close the valve of the equipment. (Valve) Manual Test Initialize the pressure sensor of the chamber and the vaporizer. (ETC) GC STERLINK mini - User Manual...
- Page 42 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. If the oil of vacuum pump is not replaced regularly, not used for a long time or the use frequency ∎...
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Page 43: Reports And Files
Chapter 7. Reports and files 7.1. Reports The cycle report is automatically created and displayed by the GC STERLINK mini 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 44 Examples of the short- format report are illustrated in the following figure. Figure 7.2 Short format report for passed and failed cycle (Sample) GC STERLINK mini - User Manual...
- Page 45 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. Figure 7.3 Long format report for passed and failed cycle (Sample) GC STERLINK mini - User Manual...
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Page 46: Data
Information is extracted from the cycle history data to produce the printed report. The history file is stored in the GC STERLINK mini sterilizer. The sterilizer displays data from the previous 80 cycles. After completing 80 cycles, the oldest cycle record is replaced with the new record for the 81 cycle. -
Page 47: Maintenance
Plasmapp Co., Ltd. Chapter 8. Maintenance The GC STERLINK mini 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. This chapter describes what kind of works and parts are required for the maintenance of the GC STERLINK mini sterilization system. - Page 48 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. GC STERLINK mini - User Manual...
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Page 49: Sterilant Cassettes
TURN OFF THE POWER WHEN REPLACING THE FUSE. There is a risk of electric shock if the fuse is replaced without using the fuse specifications provided by Plasmapp Co., Ltd. or when the power is switched on. 8.2. Sterilant cassettes Hydrogen peroxide (Chemical Formula: H ) in the cassettes of STERPACK™... -
Page 50: Moving, Long Term Stop And Disposal Of The Sterilizer
8.3. Moving, long term stop and disposal of the sterilizer When the GC 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 51: Trouble Shooting
Plasmapp or your local Plasmapp customer support representative. 9.1. User errors The GC 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. - Page 52 The load should be dried and try again with a new cassette. Most system errors are related to load issues. However, problems can arise due to malfunction of the GC STERLINK mini sterilization system. If the problems persist, please contact Plasmapp or your local Plasmapp customer support representative.
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Page 53: Self-Diagnostic Function
Error Code can be checked on the "History" screen by pressing the "History" button on the initial screen, and the necessary actions can be taken by referring to the Error List below. If the problems persist, please contact Plasmapp or your local Plasmapp customer support representative. - Page 54 Plasmapp Co., Ltd. Attachment A. Warranty 1. The manufacturer of Plasmapp Co., Ltd. warrants the product of GC STERLINK mini sterilizer to be free from defects in materials and workmanship for a period of one year from the delivery date.
- Page 55 Cassette containing sterilant for CHAMBER mode Store at room temperature between 15-30℃(59-86℉) STERLOAD™ Keep away from sunlight mini - Material: PC/ABS - Sterilant: Hydrogen peroxide (concentration: 58 – 59.5%) - 1 cycle per cassette, 30 cassettes per box GC STERLINK mini - User Manual...
- Page 56 Dedicated vacuum tray optimized for high vacuum sterilization with ™ STARPACK - Size: 80 mm × 195 mm × 30 mm ™ STERPACK Tray - Weight: 0.15 kg - Material: Aluminum - Dedicated for STERPACK ™ (POUCH MODE) GC STERLINK mini - User Manual...
- Page 57 - Expiration date: Refer to the product notification date Chemical indicator for sterilization cycle monitor Chemical - Size: 18 mm × 105 mm indicator strip - Packaging: 250 strips per case (CI Strip) - Expiration date: Refer to the product notification date GC STERLINK mini - User Manual...
- Page 58 Attachment C. Specifications C1. General information (1) Product name: Low temperature plasma sterilizer (2) Model: GC STERLINK mini (3) Manufacturer Company Plasmapp Co., Ltd. Address 102, Cheombok-ro, Dong-gu, Daegu, 41061, Republic of Korea +82-1544-0508 Website http://plasmapp.com/eng/ GC STERLINK mini - User Manual...
- Page 59 Size 154.9 (W) x 89.0 (H) Display Resolution 800 x 480 Port IEC-320 C14, RJ-45, USB type A, USB type B, cable connector Rated power 100 VAC, 12 A Electrical characteristic Rated frequency 50-60 GC STERLINK mini - User Manual...
- Page 60 Rev. 01 (May.08. 2023) Plasmapp Co., Ltd. User manual for the GC STERLINK mini sterilization system Manufacturer: Plasmapp Co., Ltd. 102, Cheombok-ro, Dong-gu, Daegu, 41061 Republic of Korea Website: https://plasmapp.com/eng/ TEL: +82-1544-0508 - This user manual is not for sale. -...
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