Plasmapp Sterlink FPS-15s Plus User manual

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

Rev. 03 / Jan. 2019
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STERLINK® FPS-15s Plus User Manual
2
Revised in Jan. 2019
Language: EN ▣ FR □ DE □ IT □ ES □ HU □ GR □ AT □ CZ □ SE □ PL □ NO □ BE □
STERLINKⓇ FPS-15s Plus Sterilization System
User Manual
Plasmapp Co., Ltd.
83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea
Authorized EC Representative
MedNet GmbH
Borkstraße 10, 48163 Münster, Germany
Plasmapp Customer Center [phone]
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,

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adaptation, or translation of this publication without prior written permission is prohibited. Printed in
Republic of Korea.

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REVISION HISTORY
Revision 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
Amended by modification for adding
POUCH Plus mode and changing of
GUI’s software
2019.01.11

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Contents
1. Introduction
7
1.1. How to use this User manual
7
1.2. If you have questions
7
1.3. Contact information
8
2. Safety information
9
2.1. Personal safety and first aid
9
2.2. Personal protective 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 accessories
15
3.5. Sterilant cassettes
17
4. Load preparation
20
4.1. Indications for use
20
4.2. What can be sterilized
21
4.3. Items not to be processed
21
4.4. Guidelines for preparing items to be sterilized
22
4.5. Cleaning, rinsing, and drying
22
4.6. Packaging and loading
23

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4.6.1. Instrument tray
23
4.6.2. Tray mats
23
4.6.3. Packaging
23
4.6.4. Loading
24
5. Operation
26
5.1. Before you start
26
5.2. Start and warm-up
27
5.3. Preparing the load
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 chemical indicator
36
5.8.2. Processing self-contained biological indicator
36
6. Access levels and supervisor tasks
39
6.1. Overview
39
6.2. Access levels
39
6.3. Additional utility menu
40
7. Reports and files
42
7.1. Reports
42
7.2. Data
45

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8. Maintenance
46
8.1. Manual maintenance
46
8.1.1. Cleaning the sterilizer exterior and interior chamber
46
8.1.2. Replacing label-printer paper
48
8.1.3. 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 errors
52
9.4. Sterilant cassette errors
53
9.5. Other system errors
54
9.6. Contact information
56
Attachment A. Warranty
57
Attachment B. Sterilant Cassettes, Consumables, Tray and
Accessories
58
Attachment C. Specifications
62

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Chapter 1. Introduction
1.1. How to use this User manual
If you are a user or operator of the STERLINK® FPS-15s Plus sterilizer, you must read the
"Safety information", "Load preparation", and "Operation" chapters prior to operating the
sterilizer. This "Introduction" (Chapter 1) describes configuration of this manual. "Safety
information" (Chapter 2) provides information on safety using the sterilizer. "Sterilizer
overview" (Chapter 3) describes the brief information on the sterilizer and component. "Load
preparation" (Chapter 4) explains how to prepare and package instruments for processing.
"Operation" (Chapter 5) explains how to operate the sterilizer and obtain optimal results.
If you are a supervisor 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 describes the tasks and options that are only available
through the supervisor level access. Chapter 7 "Reports and files" explains the management of
sterilization information from the sterilizer.
The chapters on "Maintenance" and "Troubleshooting," and “Attachment” are designed as
references. Keep this user manual available so that if any question arises, you quickly locate the
information you need.
1.2. If you have questions
If you have any question about operating the STERLINK® FPS-15s Plus sterilizer or what kind of
items may be safely sterilized, please call our customer service center at [phone] in
Korea. Internationally, call your local Plasmapp customer support representative. You may also
wish to visit our website at http://www.plasmapp.co.kr.

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1.3. Contact information
1.3.1. Manufacturer
Company
Plasmapp Co., Ltd.
Address
83, Jukdong-ro, Yuseong-gu, Daejeon, 34127, Republic of Korea
Tel
[phone]
Fax
[phone]
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
Tel
[phone]
email
[e-mail]
1.3.3. European certification body
Company
MTIC InterCert S.r.l
Address
Via G.Leopardi, 14, 20123 Milano (MI), Italy
email
http://www.mticert.org
1.3.4. Authorized EC representative
Company
MedNet GmbH
Address
Borkstraße 10, 48163 Münster, Germany
email
http://www.mednet-eurep.com

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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.
Always pay attention to the warnings, cautions and notes throughout this User
manual. This information is for your safety and will make sure that you receive the
best result from the safe operation of your sterilizer system.
2.1. Personal safety and first aid
WARNING! HYDROGEN PEROXIDE IS CORROSIVE.
Concentrated hydrogen peroxide is corrosive 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 occurrence.
Residual hydrogen peroxide may be present. If the contact occurs, immediately flush
skin with large amounts of water. If symptoms are severe or persist, consult a doctor
immediately.
WARNING! HYDROGEN PEROXIDE IS AN OXIDIZER.
Avoid allowing hydrogen peroxide to contact organic materials, including paper,
cotton, wood, or lubricants. Concentrated hydrogen peroxide is a strong oxidizer and
may react with organic materials, causing ignition and fire.
WARNING! RISK OF EYE INJURY.
Direct hydrogen peroxide contact with eyes can cause irreversible tissue damage. If
there is a contact with eyes, immediately rinse eyes thoroughly with a large amount of
water. Consult a physician immediately.

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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.
WARNING! RISK OF RESPIRATORY IRRITATION.
Inhalation of hydrogen peroxide mist can cause severe irritation of lungs, throat, and
nose. If you inhale it, move to fresh air. Please consult a doctor immediately if the
symptoms are severe or persist.
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.
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 or door with your bare or gloved hands. Allow the sterilizer to cool before
touching interior surfaces.
2.2. 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.

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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. Cautions 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 proper use and maintenance of the STERLINKⓇ FPS-
15s Plus Sterilizer system.
2.4. Symbols
HOT SURFACES PRESENT.
Do not touch without protection.
HAZARDOUS CHEMICAL PRESENT.
Use personal protective equipment.
TOXIC CHEMICAL PRESENT.
Avoid exposure, contact, or ingestion.
HAND CRUSH HAZARD.
Keep hands clear while operating.

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Chapter 3. Sterilizer overview
3.1. Intended use
The STERLINK® FPS-15s Plus sterilization system is a low temperature plasma sterilizer to
inactivate microorganisms for a broad range of metal and nonmetal medical devices and surgical
instruments at low temperature. This sterilizer offers an effective, safe, fast, economical, easy–to-
use, reliable, and flexible sterilization method.
When used as directed by the instruction in this User manual, please review the Chapter 4 "Load
preparation" chapter in which recommended materials and lumen sizes are described. When
selecting reusable medical devices to be processed in this sterilizer system, reprocessing
information should be obtained from the manufacturer of the medical device in accordance with
international norms (such as ISO 17664 or AAMI TIR 12).
3.2. Sterilization procedure
As a medical professional, you may already be familiar with general sterilization principles.
However, the STERLINK® FPS-15s Plus sterilizer utilize its own method, and it requires special
attention to the 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 rapidly sterilizes medical instruments and materials
without leaving toxic residues. All stages of the sterilization cycle are not damaged to compatible
instruments which are sensitive to heat and moisture.
The STERLINK® FPS-15s Plus sterilizer can be used for metal and non-metal medical devices
and can sterilize instruments that have difficult-to-reach (diffusion-restricted) spaces, such as
hinges on forceps. Please refer to "Load preparation" chapter for more information.
The sterilizer consistently provides the Sterility Assurance Level (SAL) of 10-6, as defined by U.S.
Food and Drug Administration (FDA) and international standards, for clinical use on all allowed
substrates within the limits of the claims for materials and geometries when used in accordance
with the directions in this User manual.
The devices have been pre-validated to the SAL of 10-6 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.

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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 (SRTM), Sterilization and Smart Complete
(SCTM) process. The sterilizer system is designed to operate only with the sterilant cassettes of
STERPACK®, STERPACK® Plus and STERLOAD®. Each cassette has individual barcode which
is scanned by the sterilizer to start the sterilization cycle automatically according to the barcode
identifying the type of the cassettes. This automatic scan step reduces user error and the reliability
of sterilization.
The optimized heating and drying process is provided in the SRTM process by measuring volume
of the medical devices and residual 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 two consecutive identical phases, and the critical process
parameters are controlled to be identical. The validation of the sterilization process is performed
by using the half-cycle overkill method to demonstrate the 10-6 SAL. In the SCTM process the
sterilizing agent is removed before using the sterilized medical devices to maintain the asepsis. To
ensure user safety we use an independent pressure sensor of the sterilizer to measure the residual
sterilant and perform an optimized completion process. The following table provides a brief
description for each cycle mode.
Sterilization cycle and minimum time by mode
Mode
Sterilant cassette
Cycle and minimum cycle time (unit: min)
SRTM / SCTM
Sterilization
Total
POUCH
STERPACKⓇ
3
4
7
POUCH Plus
STERPACKⓇPlus
6
8
14
CHAMBER
STERLOADⓇ
21
15
36

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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.
∎ Diffusion: 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 the chamber or pouch is reduced to
remove air and residual sterilant and water. The plasma power is applied to the plasma source
to purify residual hydrogen peroxide vapor. Specially in the Pouch mode, it is possible to
complete the quick sterilization process by directly removing the sterilizing agent from the
pouch.
Sterilization process - Phase 2
The steps in the Phase 1 are repeated.

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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.
Figure 3.1 STERLINK® FPS-15s Plus sterilization system
The STERLINK® FPS-15s Plus sterilization system can be utilized with the optional label-printer
in order for the user to print the reports summarizing sterilization cycle information. This label-
printer prints as sticker type the report for user convenience to manage the history of cycle
information.
Printer
Cart
Sterilizer

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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”.
Figure 3.3 Label-printer for STERLINK® FPS-15s Plus sterilization system

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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
sterilant cassettes of STERPACK®, STERPACK® Plus and STERLOAD®, respectively. The
barcode contains information of the type and date of manufacture of the sterilant cassette.
Figure 3.4 Sterilant cassette of STERPACK®
Figure 3.5 Sterilant cassette of STERPACK® Plus
Barcode
Barcode and date of manufacture

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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. When the sterilization cycle is completed or stopped, the used cassettes should
be handled with wearing 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 DATE.
When you use the sterilant cassettes (STERPACK®, STERPACK® Plus, STERLOAD®),
check the expiry date. If the date is expired, dispose and use new available sterilant
cassettes.
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.
Barcode and date of manufacture

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Chapter 4. Load preparation
4.1. Indications for use
The STERLINK® FPS-15s Plus sterilizer is designed for sterilization of both metal and nonmetal
medical devices at low temperatures. The sterilization process is a multiphase sterilization process
that utilizes a combination of exposure to hydrogen peroxide vapor and plasma to complete the
sterilization cycle.
The sterilizer can sterilize instruments which have diffusion-restricted spaces, such as the hinged
portion of forceps and scissors. Medical devices with the following materials and dimensions can
be processed in the STERLINK® FPS-15s Plus sterilization cycles:
∎ Single-channel stainless steel lumens with an inside diameter of 0.7 mm or larger and a length
of 500 mm or shorter.
∎ Single-channel 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 2,000 mm or shorter.
CAUTION! KNOW WHAT YOU CAN PROCESS.
Before processing items in the sterilizer, make sure you know how the STERLINK®
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.
Improper processing may limit liability for damage to processed instruments. The
manufacturer can not warrant the damage of the instruments due to improper use.
The STERLINK® FPS-15s Plus sterilizer is compatible for sterilizing the non-invasive and
invasive medical devices, such as denture, endoscopes, ocular prosthesis, intraosseous
transcutaneous amputation prosthesis, and surgical equipment.