Atie Medical Industries PS-140 User manual

ATIE MEDICAL INDUSTRIES
PS-140
PLASMA STERILIZER
USER MANUAL
CONTACT:
Address:
No.2 - West 12th Alley - Bokharest St. - Arjantin Sq. - Tehran - Iran
Phone :
[phone]

TABLE OF CONTENTS
Atie Medical Industries
CHAPTER ONE INTRODUCTION PAGE 4
CHAPTER TWO SAFETY INFORMATION PAGE 5
CHAPTER THREE DEVICE OVERVIEW PAGE 10
CHAPTER FOUR LOAD PREPARATION PAGE 15
CHAPTER FIVE FEATURES PAGE 20
CHAPTER SIX OPERATION PAGE 24
CHAPTER SEVEN MAINTENANCE PAGE 38
CHAPTER EIGHT PHYSICAL PROPERTIES PAGE 44

How To Use This Manual?
If You Have Question?
Atie Medical Industries
This guide, explains the instructions on how to use with the PS-140 Plasma
Sterilizer, This guide includes all the essentioal information that is needed to
work with the PS-140.
This guide should be available to the operator and should be near the device,
so when it is needed, it would be available.
It is necessary that you read the safety issues about operator and the device
before using the device,
All the necessary instruction before using the device, when loading, and in
removing the equipment from the device is explained in this guild. All these
items must be applied for proper use.
Please call us if you have any question about the device. the customer service
phone number is on the rst page.
Chapter one
Introduction
PS-140 User ManualPage - 4
chapter 1
Introduction

Chapter Two
Safety Information
Personal Safety Information
This is so important for us and it is our primary concern that you are safe
when you are using PS-140. This chapter presents information on safety us-
ing this device. You must read and follow the safety information. You must
understand them before you start to operate the sterilizer.
Please pay attention to all the warnings, all the cautions, and notes in this us-
er’s guide. These are for your safety and to ensure that you receive the most
benet from the safe operation of this device.
WARNING! HYDROGEN PEROXIDE IS CORROSIVE
Hydrogen peroxide is corrosive to skin, eyes, nose, throat, lungs, and
gastrointestinal tract and to all the body. Please always wear latex PVC
(vinyl), or nitrile gloves while you loading a cartridge. Or when you remove
the used cartridge. Please always wear the gloves when you remove the
items in a load of a canceled cycle. We considered a safe-mode cycle for
canceled cycles. But if you cancel the safe-mode cycle or the load show
any visible moisture or liquid, that might be hydrogen peroxide. So please
be careful when this happened.
WARNING! HYDROGEN PEROXIDE IS AN OXIDIZER
Hydrogen peroxide is an oxidizer. So avoid allowing hydrogen peroxide
to contact any organic material, including paper, cotton, wood, any oil,
lubricants. The hydrogen peroxide is a strong oxidizer and it can react
with organic materials, it is not ammable itself, but it can be the cause
of re or ignition.
WARNING! RISK OF EYE INJURY
If hydrogen peroxide directly contacts with eyes, it can cause irreversible
tissue damage.
If contact with eyes occurs, immediately ush with a large amount of
water and consult with a physician immediately.
WARNING! RISK OF SKIN INJURY
If hydrogen peroxide directly contacts with skin, it can cause severe
irritation. If skin contact occurs, immediately ush with large amounts of
water. If symptoms are severe or persist, consult a physician immediately
Atie Medical Industries
Page - 5
chapter 2
Safety Information
PS-140 User Manual

WARNING! RISK OF RESPIRATORY IRRITATION
Inhalation of hydrogen peroxide must or vapor can cause severe
irritation of lungs, throat, and nose. If inhalation occurs, move to fresh
air. Never breathe the air upon the opened cartridge. Consult a physician
immediately.
chapter 2
Safety Information
WARNING! CONCENTRATED HYDROGEN PEROXIDE IS TOXIC
Ingestion or drinking hydrogen peroxide may be life-threatening. If
swallowed, drink plenty of water immediately to dilute. Do not induce
vomiting. Consult a physician immediately.
WARNING! HOT STERILIZATION SURFACES
At the end of the cycle, the interior of the sterilizer, the chamber, may be
hot. Do not touch inside the chamber with bare or gloved hands. Allow
the sterilizer to cool before touching interior surfaces.
CAUTION! AVOID EXPOSURE TO ULTRAVIOLET LIGHT
There is a sight glass on the door of the device in some models. Do not
stare at the chamber through sight glass during the plasma stage.
Personal Protective Equipment
CAUTION: RISK OF HYDROGEN PEROXIDE CONTACT
Always wear latex, PVC (vinyl), or nitrile gloves whenever handling a
cartridge. Or when a cycle has been canceled and also the safe-mode cycle
has been canceled wear gloves to remove the items from the chamber.
Device Safety
WARNING! RISK OF INJURY OR DAMAGE TO STERILIZER
The PS140- Plasma Sterilizer should not be used stacked with other
equipment.
CAUTION: RISK OF DAMAGE TO LOAD
Metal objects must not come into contact with the chamber walls, the
door, or the electrode. Contact with the walls, door or electrode could
damage the sterilizer or the metal object and load. It may cause to a re
inside the chamber. So please be careful during the loading.
Atie Medical Industries
PS-140 User ManualPage - 6

WARNING! YOU MUST KNOW WHAT THIS DEVICE DO AND
WHAT YOU CAN PROCESS
Before using this machine, it is important that you know how to process
items with this machine. You should know the effects of this device on
your items. Please read the instruction before use. Please follow the device
manufacturers’ instructions for their products. There is a list in this guide
that tells you what is safe to be sterilized in this device and what shouldn’t
be processed with this device. Do not replace this instruction with other
medical device manufacturers’ instructions. If you have a question, or if
you are in doubt about the materials in your devices, contact the medical
device manufacturer. Then if it can be sterile in this device, then process
the device in this sterilizer.
chapter 2
Safety Information
CAUTION! RISK OF VIOLATING OF WARRANTY
Improper processing may limit our liability for damage to processed
instruments.
Improper processing may also violate your instrument warranty.
CAUTION! RISK OF DAMAGE TO LOAD – METAL OBJECT
Please be careful when you load metal objects in the chamber. Metal
objects must not come into contact with the chamber walls, the doors, or
the electrode. Contact with the walls, doors or electrode could damage
the sterilizer itself or the metal objects. It also could start to a re inside
the chamber. So please be careful during loading.
CAUTION! RISK OF DAMAGE TO LOAD – VENTING CAPS
You should take care about venting caps, these caps should be placed
according to the manufacturer’s instructions. You should conrm that.
Venting caps are intended to prevent damage to exible scopes that are
being exposed to a vacuum, regardless of the sterile agent that used.
CAUTION! RISK OF DAMAGE TO LOAD – IMMERSION CAPS
You must remove the water-resistant immersion cap (if present) prior to
processing in the sterilizer. If the immersion cap is not removed prior to
processing in the PS140- sterilizer, it will damage the exible scope due to
the inability to properly vent.
CAUTION: RISK OF INAPPROPRIATE LOAD
If you want to process exible endoscope in this sterilizer, you must read,
understand and follow the medical device manufacturer’s instruction for
use the particular scope into the process. For more information please
contact the medical device’s manufacturer.
Atie Medical Industries
Page - 7PS-140 User Manual

Warnings and Cautions are accompanied by symbols surrounded by a
triangle or a square and are printed in the text in bold. Warnings indicate
events or conditions that can result in serious injury or death. Cautions
indicate events or condition that can result in severe damage to the
equipment.
chapter 2
Safety Information
Warnings, Cautions, and Notes
Notes have a checkmark in front of the word “Note.” Notes highlight
specic information about proper use and maintenance of the PS140-
Plasma Sterilizer.
Symbols Used on the device
and in This Guide
Hot surface present
Do not touch without protection
Hazardous / corrosive chemical present.
Use personal protective equipment.
Oxidizing chemical present
Avoid exposure, contact, or ingestion.
Avoid organic material, oils, and ammable material.
Use personal protective equipment
Toxic chemical present.
Avoid exposure, contact or ingestion.
Atie Medical Industries
PS-140 User ManualPage - 8

chapter 2
Safety Information
Ultraviolet (UV) light hazard.
Do not look at sight glass of the device.
High voltage hazard.
Electrical Shock Hazard
On / Off
power switch
door up (open) switch
door down (close) switch
Emergency Stop switch
Earth Connection
Alternating Current
Hand Pinching Warning
Atie Medical Industries
Page - 9PS-140 User Manual

Chapter Three
Device Overview
The PS-140 sterilization system is a low-temperature sterilizer which you can
process our sterilization cycle to inactive microorganisms on a broad range
of medical devices and surgical instruments with it. This sterilizer offers an
effective, safe, pretty fast, very economical, so easy to use and user-friendly,
reliable sterilization method.
The Plasma Sterilizer PS-140 is a low-temperature sterilizer, designed to use
in the central sterile supply department (CSSD) of the hospital to complete
the functionality of CSSD departments. This device is used for disinfection
equipment that is temperature sensitive.
It can be used by a trained qualied operator who has basic knowledge of
sterile processes inside a clinic or hospital.
This device can sterile both metal and non-metal medical devices that are
mentioned in this guide.
chapter 3
Device Overview
Intended Use
Sterilization Cycle
The PS-140 has two types of sterilization cycles.
- Standard (Short) cycle
- Lumen (Long) cycle
The type of cycle will be chosen by the operator. Both cycles will guarantee
a Sterility Assurance Level (SAL) of 106respective to the types of loads that
can be sterilized in the chosen cycle.
These are the cycle steps for both short and lumen cycles:
After the cycle started:
1.Hydrogen peroxide will be pumped from the cartridge into the vaporizer.
2.The hydrogen peroxide will be concentrated in the vaporizer.
3.The chamber will be vacuumed.
4.Hydrogen peroxide vapor will be injected into the chamber.
5.All the items inside the chamber exposed to concentrated hydrogen per-
oxide vapor.
6.The pressure inside the chamber will be increased.
7.The chamber will be vacuumed and plasma phase will be applied in the
chamber.
8.All the steps above will be repeated one more time.
Atie Medical Industries
PS-140 User ManualPage - 10

You nd these things on the device when you are processing a cycle.
1- Cartridge
2- Delivery block
3- Chamber
4- Door
5- Sight glass
6- Printer
7- Incubator
8- LCD touchscreen display
9- Main Power Switch / (On / Off Switch)
10- Emergency stop switch
11- Door up switch
12- Door down switch
chapter 3
Device Overview
The PS-140 Features
Door
Incubator
Chamber
Delivery Block
Main Panel
Sight Glass
LCD Touchscreen Display
Main Power Switch
Door Up Switch
Door Down Switch
Emergency Switch
Printer
Atie Medical Industries
Page - 11PS-140 User Manual

The cartridge is the hydrogen peroxide bottle that contains enough
sterilizer agent for a cycle.
chapter 3
Device Overview
Cartridge
This block would come out from the device before cycle, and you
open the lid of the cartridge and put the bottle and lid in it, then after
conrmation, it will go inside the device.
Delivery block
Cartridge Lid Place
Cartridge Place
Chamber is the place that you put the items that you want to be
processed in it. It is made from stainless steel 316, and it is resistant
to corrosion effects of hydrogen peroxide. Inside the chamber you
can see plates that are perforated, these are electrodes for apply-
ing electric eld inside the chamber to make plasma. The chamber
has to shelves, you can use only one of the shelves and bring one
of them out for items that are big that cannot be loaded when two
shelves are in the chamber. The hydrogen peroxide path is at the
bottom of the chamber.
The chamber walls heated up to 65 degrees during the cycle of ster-
ile so it is important to pay attention about the hot surface warning
Chamber
WARNING! HOT STERILIZATION SURFACES
The interior of the chamber, may be hot. Do not touch inside the chamber
with bare or gloved hands after cycle. Allow the sterilizer to cool before
touching interior surfaces.
Atie Medical Industries
PS-140 User ManualPage - 12

The door of the PS-140 has upside (open)/downside (close) move-
ment and also has an axial movement.
chapter 3
Device Overview
Door
There is a sight glass on the door, please don’t see inside the cham-
ber when the device is in the plasma stage.
Sight Glass
CAUTION! AVOID EXPOSURE TO ULTRAVIOLET LIGHT
There is a sight glass on the door of the device in some models. Do not
stare at the chamber through sight glass during the plasma stage.
The sterilizer is equipped with an integrated internal printer located
in the front panel, the printer prints cycle reports on a roll of thermal
paper. The printer features easy, drop-in paper loading and require
no ink cartridges.
The button on the printer advances the paper, and if you pull the
handle the door of the printer will be opened and you can replace
the roll of paper.
Printer
The sterilizer displays the information and accepts commands
through a 7 inch LCD color touchscreen display. By touching buttons
displayed on the screen, you can control the device.
Incubator
You can incubate your standard vials in the internal incubator in the
device.
For turning on the incubator you must turn the on/off switch on the
incubator unit.
Its temperature is set on 57degrees.
LCD touchscreen display
Atie Medical Industries
Page - 13PS-140 User Manual

To tuning on the device, you should turn the on/off switch to on
state. For turning off the device you can turn the on/off switch on
the main panel of the device to the off state.
chapter 3
Device Overview
Switches
Main Power Switch
(On / Off Switch)
If you push this button all of the device’s operations would be paused.
If the device was during the cycle, then you have 2 minutes to re-
sume the cycle by inactivating the emergency switch, otherwise, the
cycle will be canceled.
Emergency stop
If the device was not during a process, then if you push the door
up key on the main panel of the device, the door will start moving
upward and the door will be opened. During this movement, if you
push the door up or door down button then the door will be stopped.
If you push the door down button then the door will move down-
ward and the door will be closed. During this movement, if you push
the door up or door down buttons the door will be stopped.
If the chamber’s pressure was not appropriate for opening the door
then the door will not be opened.
Door up / down switches
Atie Medical Industries
PS-140 User ManualPage - 14

Chapter Four
Load Preparation
The PS-140 sterilizer is designed to sterilize both metal and non-metal medi-
cal devices at low temperature. Our cycle uses hydrogen peroxide vapor and
plasma for the process to get done. Because the cycle operates in a dry and
low-temperature environment, then it will be suitable for instruments that
are sensitive to temperature or to moisture.
chapter 4
Load Preparation
Intended Use
CAUTION! YOU MUST KNOW WHAT YOU CAN PROCESS AND
WHAT YOU CANNOT PROCESS.
Before processing items in the sterilizer, make sure that you know how to
use the device, and how the PS-140 sterile cycle affect your items. If you
have any question you can contact the medical device manufacturer or you
can contact us.
CAUTION: RISK OF VIOLATING THE WARRANTY
Improper processing may limit our liability for damage to the processed in-
struments.
Improper processing may also violate your instrument warranty.
CAUTION: DO NOT PROCESS ITEMS OUT OF THE ITEMS MEN-
TIONED HERE
Never process items that are not mentioned in this guide.
Never process the items that mentioned here to not to be processed in this
device, because otherwise, these items may damage your device or the re-
sult of the sterile cycle cannot be guaranteed.
Atie Medical Industries
Page - 15PS-140 User Manual

Single-use items which the manufacturer does not recommend re-steriliza-
tion.
Liquids and powders
Items or material that absorb liquids.
Items or material that contain cellulose, such as cotton, paper or cardboard,
linens, huck towels, gauze sponges, any item containing wood pulp.
Paper instrument count sheets or lot stickers.
Items with mated Nylon® surfaces.
Instruments and devices that cannot withstand a vacuum and are labeled for
gravity steam sterilization methods only.
Items whose design permits the surfaces to collapse onto each other unless
some method is used to keep the surfaces separated.
Dead-end lumens must not be processed.
Devices with internal parts, such as sealed bearings, that cannot be im-
mersed, may present difculties in cleaning and should not be processed in
PS-140 sterilizer.
Instruments that are wet or moist.
Instruments that in their design two surfaces meet each other which hydro-
gen peroxide vapor cannot penetrate, it is necessary to separate these parts
before the process.
Lumens which can be processed in the PS-140
Items not to be processed
Preparing items to be sterilized
Note: all the items must be cleaned, rinsed, and thoroughly dried before be-
ing placed in the PS-140. Loades containing moisture can extend the cycle
time, and also may damage the sterilizer vacuum pump.
chapter 4
Load Preparation Atie Medical Industries
PS-140 User ManualPage - 16

Items not to be processed
Cleaning and sterilization are two separate processes. Proper cleaning of in-
struments and devices in a critical and necessary step prior to sterilization.
All items must be thoroughly cleaned, rinsed and dried before loading into
the sterilizer.
Carefully inspect all instruments and devices for cleanliness and dryness and
for aws or damage prior to packaging. If visible soil or moisture is present,
items must be re-cleaned and dried prior to sterilization.
Devices and instruments with aws or damage should be replaced or re-
paired before using.
The process of cleaning is necessary to remove organic and inorganic soil
and debris or any remaining of them from the equipment. This process also
removes many microorganisms from the surface of the items. The process of
sterilization then inactivates all remaining spores and live microorganisms.
Remove all blood, tissue, and soil from items by following the device manu-
facturer’s instructions using an appropriate detergent.
Rinse items thoroughly to remove detergent or cleanser residue.
We emphasize that all the items must be dried. An acceptable method for
drying is to blow compressed air through the lumen until no moisture exits
the distal end of the device. Please ensure that any method used to dry the
devices is in accordance with the manufacturer’s instructions for use. If you
don’t know how to do this properly and safely, you should ask the manufac-
turer of that medical device. It is necessary to remove moisture from all parts
of the items.
Only dry items should be loaded into the sterilization chamber to prevent an
imperfect cycle.
Some complex reusable devices that can be disassembled, require disas-
sembly for proper cleaning and sterilization. It is very important that you fol-
low the device manufacturer’s recommendations concerning cleaning and
sterilization.
WARNING! POSSIBLE NON-STERILE DEVICE
Loads containing moisture may result in either a non-sterile device or ex-
tended cycle.
Note: periodic careful inspection of items after repeated exposure to dis-
infectant/ cleaner is necessary, due to potentially damaging effects of the
chemical agent on the items.
chapter 4
Load Preparation
Atie Medical Industries
Page - 17PS-140 User Manual

Packaging
If you want to package the instruments that we recommend you do this,
proper preparation of poaches, and instruments can minimize or prevent
positive biological indicators (BI). Positive biological indicator test results are
may be the result of load-related problems. All instruments must be cleaned,
rinsed and thoroughly dried before loading into the sterilizer.
Special consideration for loading and processing exible endoscopes should
be taken place.
Never use linen, cellulose, or any materials listed in the “Items not to be pro-
cessed” section.
Do not use foam pads in trays, because they can absorb the hydrogen per-
oxide.
Use only hydrogen peroxide/plasma sterilizer compatible polypropylene
sterilization wrap and Tyvek® pouches.
Do not use paper poaches or sterilization wraps containing cellulose or cot-
ton.
Always properly arrange the items or the scope in a tray to ensure adequate
diffusion of hydrogen peroxide throughout the load.
Always arrange the items so that the transparent side of a pouch faces the
opaque side of the next pouch.
Do not stack pouches on top of each other.
Do not stack instruments inside the trays.
Do not wrap instruments within another wrapped box.
Place chemical indicator strips inside any pouches as needed.
LOADING
Do not allow any item to touch the walls of the sterilization chamber, door
or electrode.
CAUTION: RISK TO DAMAGE TO LOAD OR TO STERILIZER
Do not allow metal objects to come into contact with the walls of the cham-
ber door, or electrode. Contact with the walls, door, or electrode can cause
damage to items or to the sterilizer.
The shelves are designed to prevent the undesired contact with electrodes
but inspect carefully to prevent any problem.
chapter 4
Load Preparation Atie Medical Industries
PS-140 User ManualPage - 18

Chemical indicators
We recommend you to use hydrogen peroxide chemical indicator strips to
verify the hydrogen peroxide diffusion in the chamber.
Note that chemical indicators are not a substitute for biological indicators.
If you use chemical indicator strips or chemical indicator tape, follow the in-
structions for use that accompany these items as you prepare the load.
• Place chemical indicator strips inside Tyvek® pouches.
• Do not use chemical indicators designed for other sterilization pro-
cesses.
Special considerations for exible endoscopes
Flexible endoscopes are sensitive and complex medical instruments. Read
the exible endoscope manufacturer’s instructions for each endoscope be-
fore preparation and loading into the PS-140 sterilizer.
Take special care to conrm that venting caps are placed according to the
manufacturer’s instructions. Venting caps are intended to prevent damage
to scopes that are being exposed to a vacuum, regardless of the disinfectant
used.
In addition, if you are processing a exible endoscope containing water re-
sistant “immersion” cap in the sterilizer, you must remove the immersion cap
prior to processing. If the immersion cap is not removed prior to processing
in the PS-140 sterilizer, it will damage the scope due to the inability to prop-
erly vent.
One or two exible endoscopes, with or without a silicone mat, can be pro-
cessed per cycle. Do not add any additional items to the load.
If you are loading items such as lumens, the number of all the items should
not more than 10.
CAUTION: RISK OF DAMAGE TO LOAD
Prior to processing exible endoscope in the PS-140 sterilizer, please con-
tact the medical device manufacturer about the compatibility of your de-
vice with plasma sterilizers.
chapter 4
Load Preparation
Atie Medical Industries
Page - 19PS-140 User Manual

Chapter Five
Features
In this chapter, we introduce the functions of PS-140 in general and in the
next chamber they will be explained.
Note: In this chapter, we presume that the device is installed.
How to start the device?
To start the device, you have to turn the main On/Off switch to the ON state.
Warming up
After you turn the sterilizer on, the sterilizer begins the warming up routine.
This may be take up to 30 minutes.
Before this 30 minutes, you cannot process the items.
Note! Do not turn the device off during the warming-up routine.
If you turn off the device before the warm-up time, you should wait the
whole time again.
If you turn off the device after the warm-up time, the device assumes itself
that it is warmed up, and next time you turn the device on you don’t need to
wait.
Loading
In previous chapter, it is explained that how to load the items safely and
properly.
Loading indicators:
To verify the cycle, and to verify the hydrogen peroxide diffusion in the de-
vice you can load chemical and biological indicators in the device.
You can verify the cycle with the biological indicator.
chapter 5
Features Atie Medical Industries
PS-140 User ManualPage - 20