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Rev. 03 / Jan. 2019

Plasmapp Co., Ltd.

STERLINK

FPS-15s Plus User Manual

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

Tel

+82-42-716-2115

Fax

+82-42-716-2116

Website

http://www.plasmapp.co.kr

(4) Manufacturing business license number: 5307 (MDITAC, Republic of Korea)

(5) Medical device manufacturing permit number: 17-4579 (MDITAC, Republic of Korea)

(6) Serial number and manufacturing date

- Serial number: Declared after manufacturing

- Manufacturing date: Declared after manufacturing

(7) European certification body

Company

MTIC InterCert S.r.l

Address

Via G. Leopardi, 14, 20123 Milano (MI), Italy

Website

http://www.mticert.org

Содержание Sterlink FPS-15s Plus

Страница 1: ...Language EN STERLINK FPS 15s Plus Plus User Manual FPS 15s Plus FPS 15s User Manual Low temperature plasma sterilizer by Plasmapp Co Ltd...

Страница 2: ...useong gu Daejeon 34127 Republic of Korea Authorized EC Representative MedNet GmbH Borkstra e 10 48163 M nster Germany Plasmapp Customer Center 82 42 716 2115 Plasmapp International Customer Support C...

Страница 3: ...Rev 03 Jan 2019 Plasmapp Co Ltd STERLINK FPS 15s Plus User Manual 3 adaptation or translation of this publication without prior written permission is prohibited Printed in Republic of Korea...

Страница 4: ...No Description of changes Date Approver 0 Initial release 2017 10 12 01 Amended by reflection of Risk management usability 2018 06 30 02 Amended by modification for changing software GUI 2018 07 27 03...

Страница 5: ...equipment 10 2 3 Warning cautions and notes 11 2 4 Symbols 11 3 Sterilizer overview 12 3 1 Intended use 12 3 2 Sterilization procedure 12 3 3 Sterilization cycle 13 3 4 Sterilizer system and accessor...

Страница 6: ...ad 28 5 4 Cassette Loading 29 5 5 Starting sterilization cycle 30 5 6 Cycle in progress and completed 32 5 7 Cancelling sterilization cycle 34 5 8 Processing a sterilized load 36 5 8 1 Inspecting chem...

Страница 7: ...Routine sterilizer maintenance 48 8 2 Sterilant cassettes 48 8 3 Moving long term stop and disposal of the sterilizer 49 9 Troubleshooting 50 9 1 System features 50 9 2 Software update 51 9 3 User err...

Страница 8: ...isor overseeing the STERLINK FPS 15s Plus sterilizer you should read the entire user manual and pay attention following Chapters 5 Chapter 6 Access levels and supervisor level tasks This chapter descr...

Страница 9: ...ww plasmapp co kr 1 3 2 Customer care center Company Plasmapp Co Ltd Address 83 Jukdong ro Yuseong gu Daejeon 34127 Republic of Korea Tel 82 42 716 2115 email plasmapp plasmapp co kr 1 3 3 European ce...

Страница 10: ...orrosive to skin eyes nose throat lungs and the gastrointestinal tract Always wear latex PVC vinyl or nitrile gloves while removing items from the sterilizer following any cancelled cycle or error occ...

Страница 11: ...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 con...

Страница 12: ...tions indicate events or conditions that can result in severe damage to the equipment Notes are accompanied by a check mark and are printed in italics Notes highlight specific information about the pr...

Страница 13: ...e ways in which it differs from other conventional sterilizers The STERLINK FPS 15s Plus sterilizer can sterilize medical devices by diffusing hydrogen peroxide vapor into the chamber or pouch It rapi...

Страница 14: ...esidual water left on the devices in which the pressure of the pouch and chamber is independently controlled to obtain the venting and pumping pressure curves The sterilization process consists of the...

Страница 15: ...sion Pressure in the chamber or pouch is increased in order to apply hydrogen peroxide to the surfaces of the devices and into the lumens of the load Plasma purification Vacuuming The pressure within...

Страница 16: ...s the complete sterilizer system including the accessories Figure 3 1 STERLINK FPS 15s Plus sterilization system The STERLINK FPS 15s Plus sterilization system can be utilized with the optional label...

Страница 17: ...s 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 feat...

Страница 18: ...MBER mode which are automatically initiated by using the barcoded printed on the sterilant cassettes of STERPACK STERPACK Plus and STERLOAD respectively The barcode contains information of the type an...

Страница 19: ...ng protective gloves and have to be disposed according the right regulation Please refer to the Chapter 5 featuring Operation to have more information on how to use the cassette CAUTION CHECK EXPIRY D...

Страница 20: ...hannel stainless steel lumens with an inside diameter of 2 mm or larger and a length of 1 500 mm or shorter Single channel Teflon PTFE lumens with an inside diameter of 1 mm or larger and a length of...

Страница 21: ...the sterilizer the list of compatible items continues to expand Information will be updated as new information becomes available If the user has any doubt please contact the medical device manufactur...

Страница 22: ...cancellation 4 5 Cleaning rinsing and drying The cleaning and sterilization are two separated processes As with all sterilization methods proper cleaning of instruments and devices is a critical and...

Страница 23: ...ing If you choose to package the instruments proper preparation of trays pouches and instruments can minimize the possibility of the cycle cancellations and positive biological indicator BI results du...

Страница 24: ...containers Do not stack containers Do not stack containers within containers Do not wrap instruments within the containers Place chemical indicator strips inside trays and pouches as needed 4 6 4 Loa...

Страница 25: ...mapp Co Ltd STERLINK FPS 15s Plus User Manual 25 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...

Страница 26: ...connector is used only expert of manufacture It is intended use for S W update or diagnosis of product status WARNING HYDROGEN PEROXIDE IS CORROSIVE Concentrated hydrogen peroxide is corrosive to ski...

Страница 27: ...dy stage Number Name Description 1 Preheating For components that require temperature control of chamber or vaporizer to make the product ready the product will be preheat 2 Configuration The display...

Страница 28: ...g POUCH Plus Total mass of the items should be less than 1 5 kg CHAMBER Total mass of the items should be less than 5 kg WARNING POSSIBLE NON STERILE DEVICE Improper sealing of the STERPACK STERPACK P...

Страница 29: ...llowing figure Figure 5 2 Loading cassettes of the STERPACK and STERLOAD WARNING STERILIZATION SURFACES At the end of a cycle the interior of the sterilizer may be hot Do not touch the inside of the c...

Страница 30: ...izer automatically check the door status and start the sterilization cycle Figure 5 3 GUIs for the initializing and SRTM process Number Name Description 7 Barcode This section displays the barcode sca...

Страница 31: ...xposed to residual sterilant which can be left in the cassette Ensure protective gloves are worn when handling an used cassette WARNING POSSIBLE NON STERILE DEVICE Improper loading of the cassette may...

Страница 32: ...ng during the drying process 15 Sterilization status The status image will be blinking during the sterilization process 16 Sterilization time The remaining sterilization process time is displayed When...

Страница 33: ...ays the date of the sterilization cycle 19 Cycle time This section displays time for overall cycle time 20 Mode This section displays the mode of the finished sterilization cycle 21 Result This sectio...

Страница 34: ...cellation to stop the cancellation process Figure 5 6 GUIs for one of the sterilization process and user confirm Number Name Description 24 STOP This icon is for cancelling the cycle 25 Confirm This i...

Страница 35: ...the loads Wear protective gloves when handling the load and used cassettes As depicted in the final GUI the sterility assurance level may not be obtained and it requires to restart a new sterilizatio...

Страница 36: ...indicators exhibit the correct color change and the cycle printout shows that all parameters were met the sterilized load is ready for immediate use following your facility s policy If the chemical in...

Страница 37: ...Rev 03 Jan 2019 Plasmapp Co Ltd STERLINK FPS 15s Plus User Manual 37 Cycle completion flowchart...

Страница 38: ...Rev 03 Jan 2019 Plasmapp Co Ltd STERLINK FPS 15s Plus User Manual 38 Biological indicator processing flowchart...

Страница 39: ...The STERLINK FPS 15s Plus 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...

Страница 40: ...word display This section displays the password entered The default setting for the password is 1111 4 OK key The key is for confirming the password 5 Back This icon is for going back to the user scre...

Страница 41: ...enting filter is contaminated or blocked with other objects the venting process can be failed and door cannot be opened When it occurs this Door open can be used to open the door Note that this key is...

Страница 42: ...y when the cycle is passed and failed Number Name Description 1 Date This section displays the date of the sterilization cycle 2 Cycle time This section displays time for overall cycle time 3 Mode Thi...

Страница 43: ...rmat report is useful for record keeping purposes and label print is convenient to provide traceability of sterilized loads Examples of the short format report are illustrated in the following figure...

Страница 44: ...d out in the short or long format depending on user purpose and choice The long format report is useful for detailed cycle quality control and contains valuable diagnostics information for customer se...

Страница 45: ...des identifying information about the sterilizer time date cycle duration information process data from the sensors of the sterilizer Information is extracted from the cycle history data to produce th...

Страница 46: ...tenance Notes Repairs and adjustments should only be attempted by experienced technicians who are fully trained to maintain and repair the STERLINK FPS 15s Plus sterilizer Use of unauthorized parts fo...

Страница 47: ...may result in damage to the sterilizer and may void the warranty WARNING STERILIZATION SURFACES At the end of a cycle the interior of the sterilizer may be hot Do not touch the inside of the chamber o...

Страница 48: ...gests for sterilizer maintenance please contact your local Plasmapp customer support representative 8 2 Sterilant cassettes Hydrogen peroxide Chemical Formula H2O2 in the cassettes of STERPACK STERPAC...

Страница 49: ...emperature 10 40 When the system is reactivated after long stop the user shall contact the manufacturer of the sterilization system and the authorized person of the manufacturer to take a proper instr...

Страница 50: ...ufacturer or the local 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 representa...

Страница 51: ...it will take several minutes for completing the update and the system will be rebooted when completed The update may be failed by the unstable internet connection and can be postponed depending on the...

Страница 52: ...esentative Figure 9 3 GUIs for user errors Number Name Description 3 Confirm The user should confirm the error when the source of the problem is checked and understood 4 DOOR NOT CLOSED Probable cause...

Страница 53: ...resentative Figure 9 4 GUIs for the errors related with the sterilant cassettes Number Name Description 7 Confirm The user should confirm the reason of the error and press Confirm button 8 USED CASSET...

Страница 54: ...r after contacting customer service representative 13 SYSTEM ERROR Probable cause A component failure results in preheating error Suggestion Contact the customer service or restart the system 14 SYSTE...

Страница 55: ...to tens of minutes after the status will be ready Even the purification is well done you can find the residual sterilant WARNING POSSIBLE NON STERILE DEVICE Any error may result in a non sterile medi...

Страница 56: ...2 Plasmapp customer service center Company Plasmapp Co Ltd Address 83 Jukdong ro Yuseong gu Daejeon 34127 Republic of Korea Tel 82 42 716 2115 email plasmapp plasmapp co kr Website http www plasmapp...

Страница 57: ...nty does not apply to repairs or replacements required because of accident misuse neglect failure to maintain in accordance with the manufacturer s specification or cause other than ordinary use 4 For...

Страница 58: ...nt Hydrogen peroxide concentration 58 1 cycle per pouch 50 cassettes per box Product code S01 STERPACK Plus Impermeable pouch containing sterilant for POUCH Plus mode Size 240 mm 410 mm Material PP NY...

Страница 59: ...l film 1 cycle per pouch 120 pouches per box Product code P03 01 Tyvek pouch W200 Device sterile packaging pouch for CHAMBER mode Pouch width 200 mm Total length 400 mm Material Tyvek and Easy Peel fi...

Страница 60: ...mm 105 mm Weight 0 4 kg Material Aluminium Product code P01 STERPACK Tray Special vacuum tray for STERPACK Size 80 mm 195 mm 30 mm Weight 0 15 kg Material Aluminium Dedicated for STERPACK Product cod...

Страница 61: ...paper width 56 mm Product code E02 Label Sticker Roll Label sticker roll for label printer Roll width 56 mm Roll length 49 labels 6 rolls per box Product code M06 Chemical indicator tape Chemical indi...

Страница 62: ...of Korea Tel 82 42 716 2115 Fax 82 42 716 2116 Website http www plasmapp co kr 4 Manufacturing business license number 5307 MDITAC Republic of Korea 5 Medical device manufacturing permit number 17 45...

Страница 63: ...zed EC representative Company MedNet GmbH Address Borkstra e 10 48163 M nster Germany Website http www mednet eurep com 9 Intended use To provide low temperature sterilization for medical devices 10 L...

Страница 64: ...le 14 CHAMBER mode SRTM SCTM Process 21 Sterilization Process 15 Overall Cycle 36 Sterilization Sterilant Hydrogen peroxide concentration 58 Injection penetration diffusion and purification by plasma...

Страница 65: ...turer 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 Borkstra...

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