Plasmapp Sterlink FPS-15s Plus User manual

PLA-UM-SPU-004
Language: EN
STERLINK™ FPS-15s Plus User manual 1
FPS-15s Plus
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

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
2
User Manual
Plasmapp Co., Ltd.
(41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea
Plasmapp’s Customer Service Center [phone]
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.
Reproduction, adaptation, or translation of this publication without prior written permission is prohibited.
Printed in Republic of Korea.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
3
Table of Contents
Chapter 1. Introduction 5
1.1. How to Use This Manual 5
1.2. Contact Us 5
1.3. Contact Information 6
Chapter 2. Safety Information 7
2.1. Personal Safety and First Aid 7
2.2. Personal Protective Equipment 8
2.3. Warnings, Cautions and Notes 9
2.4. Symbols 9
2.5. MSDS 12
Chapter 3. Overview of the Sterilizer 13
3.1. Intended Use 13
3.2. Sterilization Processes 13
3.3. Sterilization Cycle 14
3.4. Sterilizer Systems and Accessories 15
3.5. Sterilant Cassette 17
Chapter 4. Preparation of Medical Devices 19
4.1. Indications for Use 19
4.2. Items Applicable to the Sterilizer 20
4.3. Things that Cannot Be Processed by the Sterilization System 20
4.4. Material compatibility 21
4.5. Instructions for Preparing the Items to Be Sterilized 21
4.6. Cleaning, Rinsing, and Drying 21
4.7. Packing and Loading 22
Chapter 5. Operation 24
5.1. Before Use 24
5.2. Start-up and Preheating 26
5.3. Preparations for Loading 27

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
4
5.4. Mounting Cassette 28
5.5. Starting the Sterilization Cycle 29
5.6. Progress and Completion of the Cycle 31
5.7. Cancellation of the Sterilization Cycle 322
5.8. Handling Sterilized Loads 333
5.9. How to Power Off Safely 366
Chapter 6. Access Levels and Administrator Tasks 377
6.1. Overview 37
6.2. Access Levels 37
6.3. Additional Utilities Menu 38
Chapter 7. Reports and Data 40
7.1. Reports 40
7.2. Data 42
Chapter 8. Maintenance 43
8.1. Manual Maintenance 43
8.2. Sterilization Cassette 45
8.3. Shipping, Long-Term Shutdown, and Disposal of the Sterilizer 45
Chapter 9. Troubleshooting 47
9.1. System Functions 47
9.2. User Errors 48
9.3. Sterilant Cassettes Errors 48
9.4. Self-Diagnosis Function 49
Attachment A. Warranty 51
Attachment B. Cassettes, Consumables, and Accessories 52
Attachment C. Product Specifications 55
Attachment D. Electromagnetic Compatibility Information 57

PLA-UM-SPU-004
Language: EN
STERLINK™ FPS-15s Plus User manual 5
Chapter 1. Introduction
1.1. How to Use This Manual
A user of the STERLINK™ FPS-15s Plus Sterilization System must read the ‘Safety Information’,
‘Preparation of Medical Devices,’ and ‘Operation’ sections before using it. ‘Chapter 1 Introduction’
describes the components of this user manual. ‘Chapter 2 Safety Information’ provides information
on safety and stability when using the sterilizer. ‘Chapter 3 Overview of the Sterilizer’ summarizes
the information on the sterilizer and its components. ‘Chapter 4 Preparation of Medical Devices’
describes the method of preparing and packing medical devices. ‘Chapter 5 Operation’ describes how
to use the sterilizer properly, and how to ensure optimum sterilization performance.
If you are responsible for controlling and supervising the STERLINK™ FPS-15s Plus Sterilization
System, you must read the entire user manual. It is recommended that you carefully read the sections
after Chapter 5. ‘Chapter 6 Access Privileges and Tasks Performed with Administrative Privileges’
describes the tasks and options available only to administrators with access privileges. ‘Chapter 7
Reports and Files’ describes how to manage the sterilization information provided by the sterilizer.
‘Chapter 8 Maintenance’ and ‘Chapter 9 Troubleshooting’, and ‘Attachments’ are included for your
reference. Be sure to keep this manual in a location where you can quickly and easily find the
information you need just in case a problem arises.
1.2. Contact Us
If you have any questions about the operation of the STERLINK™ FPS-15s Plus Sterilization System
or would like to know whether certain types of medical devices are sterilized safely, please contact
our customer service center at [phone] in Korea. Internationally, contact your local Plasmapp
customer support representative. You may also visit our website at http://plasmapp.com.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
6
1.3. Contact Information
1.3.1. Manufacturer
Company Name
Plasmapp
Add.
(41061) 102, Cheombok-ro, Dong-gu, Daegu, Republic of Korea
Phone
[phone]
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
[phone]
e-mail
[email protected]

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
7
Chapter 2. Safety Information
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. The information set forth
herein will help ensure your safety and achieve the best performance from the sterilizer.
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 mayreact 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 thoroughlywith a large amount ofwater. Consult
a physician immediately.
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 vapor may cause severe irritation to the lungs, throat, and
nose. If inhaled, move to a location with fresh air for breathing. If your symptoms are severe
or if they persist, contact your doctor immediately.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
8
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.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
9
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.
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™FPS-15s Plus
Sterilizer System.
2.4. Symbols
REFER TO INSTRUCTION MANUAL
WEAR SAFETY GLOVES
WARNINGS AND CAUTIONS
Warnings and cautions are indicated in the triangle symbol
WARNING SIGNS
HOT SURFACES PRESENT
Do not touch the surface without any suitable protective equipment
HAZARDOUS CHEMICAL PRESENT
Be sure to wear personal protective equipment

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
10
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
POWER ON
POWER OFF
PROPECTIVE EARTH (GROUND)
MANUFACTURER
DATE OF MANUFACTURING

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
11
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

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
12
2.5. MSDS
For more information, contact Plasmapp or your local Plasmapp customer support representative.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
13
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. It is effective, safe, fast, affordable, easy to use, and reliable by
providing a variety of sterilization solutions.
When using the sterilizer in accordance with the instructions specified in this user manual, be sure to
carefully read ‘Chapter 4 Preparation of Medical Devices’, which describes allowable medical device
materials and lumen sizes. When choosing a reusable medical device to be operated on this sterilizer
system, you should obtain the information from the manufacturer in accordance with International
Norms (ISO 17774 or AAMI TIR 12).
∎ Product Ratings and Specifications
Item
Specifications/Conditions
Voltage
100 - 120 VAC
Rated frequency
50 / 60 Hz
Max. power consumption
1.5 kVA
Operating temperature
10 ℃ - 40 ℃
Humidity
Relative humidity of 30 - 85%
Atmospheric Pressure
70 - 106 kPa
Replaceable fuse
Fuse 125V / 15A
3.2. Sterilization Processes
As a healthcare professional, you are probably already familiar with the general principles of
sterilization. However, special attention is required when handling the STERLINK™ FPS-15s Plus
Sterilizer System, which adopts its own method that is different from other existing sterilizers.
It sterilizes medical devices by diffusing hydrogen peroxide vapor into chamber. It can quickly
sterilize medical devices and materials without leaving toxic residues, and does not damage the
medical devices that are sensitive to heat and moisture.
It can be used on both metallic and non-metallic medical instruments, and it can also sterilize medical
instruments with hard-to-reach spaces (limited diffusion spaces), such as forceps. For more details,
refer to ‘Chapter 4 Preparation of Medical Devices’.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
14
The sterilizer consistently guarantees a Sterility Assurance Level (SAL) of 10-6 as defined by the US
Food and Drug Administration (FDA) and International Standards, provided that the materials and
geometrical requirements in accordance with the instructions in this user manual are met.
The pre-validation has shown that this sterilizer can reach a SAL of 10-6, 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
is the sterilization cycle that combines Smart Ready (SRTM), Sterilization, and Smart Complete (SCTM)
processes. This sterilizer system is designed to operate only with the sterilant cassette, STERLOAD™.
The cassette has a barcode printed on it. At the start of the process, the sterilizer scans the barcode to
recognize the validity of the cassette, and automatically selects the sterilization mode based on the
barcode system. This allows the system to reduce user errors and provide improved ease of use and
sterilization reliability.
In the SRTM process, the moisture remaining in the medical devices is measured with an independent
pressure sensor of the sterilizer, and the optimized heating and drying processes are conducted. The
same sterilization process is performed twice in a row, and the process parameters are managed in the
same way. It has been validated for 10-6 SAL with a half cycle of sterilization. The SCTM process
completely removes the residual sterilant and ensures the Sterility Assurance Level before using
sterilized medical devices. Particularly, to ensure user safety, an optimized completion process is
carried out by measuring the remaining sterilant with an independent pressure sensor of the sterilizer.
The following table represents a brief description of the sterilization cycle for chamber mode.
Sterilization cycle and minimum time by mode
Mode
Sterilization
Cassette
Cycles and Minimum Process Time (in minutes)
SRTM / SCTM
Sterilization
process
Total
CHAMBER
STERLOAD™
21
15
36
Sterilization process – Step 1
▪ Injection: Hydrogen peroxide (sterilant) is injected and vaporized from the cassette into the
vaporizer, and fed into chamber.
▪ Diffusion: As the sterilant vaporizes and pressure increases, it diffuses into the surface and in the
interior of the medical devices to proceed with the sterilization process.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
15
▪ 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.
Sterilization Process – Step 2
The processes in Step 1 above are repeated.
3.4. Sterilizer Systems and Accessories
Optional accessories are available for use with the STERLINK™ FPS-15s Plus Sterilization System.
The following figure shows the sterilizer system including the sterilizer cart and label-printer
accessories.
Fig. 3.1 STERLINK™ FPS-15s Plus Sterilization System
This product 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. In addition, the USB port
on the back of the main body is connected to the USB port on the back of the label printer through a
USB cable. The label printer connected to the sterilizer is supplied with power through the printer
power adapter (insulated).

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
16
Fig. 3.2 STERLINK™ FPS-15s Plus Sterilization System
Fig. 3.3 STERLINK™ FPS-15s Plus 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.
Fig. 3.4 Label Printer & Label Sticker Roll for the STERLINK™ FPS-15s Plus Sterilization System
WARNING! ELECTRIC SHOCK HAZARD.
To avoid the risk of electric shock, this product must only be connected to a power supply
with protective ground.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
17
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.
WARNING! INSTALLATION POSITION.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
3.5. Sterilant Cassette
The STERLINK™ FPS-15s Plus Sterilization System has one mode (CHAMBER mode) which is
automatically initiated by scanning the barcode printed on the STERLOAD™ sterilant cassette. The
barcode contains the information about the type and the manufacturing date of Sterilant Cassettes.
Fig. 3.5 Sterilant Cassette of STERLOAD™
The cassette has two built-in cells containing the same amount of sterilant (hydrogen peroxide), so
one complete sterilization cycle can be performed while repeating the same sterilization process using
each cell. When the sterilization cycle is completed or aborted, you need to remove the used cassette
from the sterilizer with protective gloves on, and dispose of it according to applicable regulations. For
more details about how to use the cassette, refer to ‘Chapter 5 Operation’.
The sterilant cassette is fixed and mounted by the fixing bar and the hook of the needle part inside the
main body. The Barcode Scanner mounted inside the needle part automatically recognizes the barcode
printed on the sterilant cassette and proceeds with the sterilization process.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
18
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.
WARNING! 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.

PLA-UM-SPU-004
Language: EN
STERLINK™ FPS-15s Plus User manual 19
Chapter 4. Preparation of Medical Devices
4.1. Indications for Use
The STERLINK™ FPS-15s Plus Sterilization System is designed for the sterilization of metallic and
non-metallic medical devices at low temperatures. The sterilizer is capable of sterilizing the
instruments with limited diffusion space, such as the hinged part of forceps. You can use the
STERLINK™ FPS-15s Plus sterilization cycle to sterilize the following medical instruments made
from the acceptable materials, with specific dimensions.
The STERLINK™ FPS-15s Plus Sterilization System can sterilize:
∙Instruments with diffusion-restricted spaces such as the hinged portion of forceps and
scissors
∙Medical devices with a single stainless-steel lumen with*:
-An inner diameter of 2.4 mm or larger and a length of 280 mm or shorter
* The validation testing for all lumen sizes was conducted using a maximum of five (5) lumens per
load. Hospital loads should not exceed the maximum number of lumens validated by this testing.
The validation studies were performed using a validation load with a total weigh of 3.97lbs.
WARNING! BE SURE TO UNDERSTAND THE STERILIZATION PROCESSES.
Before processing item(s) in the sterilizer, make sure you know how the STERLINK™
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.
Improper use may cause damages to the equipment, and such damages will not be covered
by the manufacturer's warranty.
The STERLINK™ FPS-15s Plus Sterilization System is also suitable for the sterilization of both non-
surgical and surgical instruments such as dentures, endoscopes, orbital implants, prostheses for bone marrow
percutaneous amputation and surgical equipment, etc.

Rev. 00 / May. 2023
Plasmapp Co., Ltd.
STERLINK™ FPS-15s Plus User Manual
20
4.2. Items Applicable to the Sterilizer
The STERLINK™ FPS-15s Plus 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.
There are many types of materials and equipment that can be sterilized with this sterilizer. As more product
tests are completed, the list of compatible items will continue to increase. It will be updated if there is any
new information. If you have any questions, please contact the medical device manufacturer or your local
Plasmapp customer support representative.
CAUTION! RISK OF DAMAGE TO MEDICAL INSTRUMENTS OR 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.
4.3. Things that Cannot Be Processed by the Sterilization System
The following items cannot be processed with the STERLINK™ FPS-15s Plus Sterilization System:
▪ Disposable items for which re-sterilization is not recommended by the manufacturer.
▪ Liquids and powders
▪ Items or materials that absorb liquids
▪ Items made of fiber-containing materials such as cotton, paper or cardboard, linen, towels, gauze and
sponges or wood pulp, etc.
▪ Medical instruments with paper labels such as stickers
▪ Items with the surface made of Nylon®
▪ Instruments that cannot withstand vacuum, and can only be sterilized by steam sterilization
▪ Instruments with a possibility of surface deformation due to vacuum
▪ Lumens blocked at one end
▪ Other tools that are not recommended for use with the STERLINK™ FPS-15s Plus sterilizer by
manufacturers