OPERATION MANUAL

Low temperature plasma sterilizer Zeus-130S

DONGBANG ACUPRIME LTD.

1 The Forrest Units, Hennock Road East,
Marsh Barton, Exeter EX2 8RU, U.K
Medonica.
94-23, Gomae-ro, Giheung-gu, Youngin-si, Gyeonggi-do, Korea
TEL +82 31-283-0234, 4 FAX +82 31-283-0231

Documentation : MN-Zeus-130S-M01

Revision History : M.01.00 Date: AUGUST 30, 2017

< CONTENTS >

Chapter 1. Introduction

1. Intended Use

2. Sterilization principle

3. Before use Checking list

Chapter 2. Safety (Cautions and Warning)

1. Safety mark

2. Safety and packaging box marked

3. Materials that can be used in plasma sterilizers

4. Materials that can not be used in plasma sterilizers

Chapter 3. Specifications

1. Product name and class

2. Shape, structure

3. Dimensions

4. Label

5. Environmental condition

Chapter 4. Installation

1. Unpacking

2. Installation and Environment

3 .Movement

4. Installation

5. Vaccum exclusion

6. Equipment TEST

7. Warm-UP

8. Storage and management method

Chapter 5. Operation

1. Preparation before use

2. Operating method

3. Running the automatic process

4. TOUCH PC screen button description (MAIN screen)

5. TOUCH PC screen button description (MONITRING)

6. TOUCH PC screen button description (SETTING & INFORMATION)

7. How to keep and manage after use

Chapter 6. Routine Maintenance

1. Routine check

Chapter 7 Trouble Shootings

1. Error message

2. Equipment Alarm

3. Other messages

Chapter 8 Purchase of consumables and A / S

1. A list of consumables and phrases route

2. A/S Desctiption

3. Warranty

Chapter 9 Electromagnetic compatibility

1. EMC

Chapter 10 Disposal

1. Instructions for disposal procedure

※ This manual is subject to change without notice.

Chapter 1. Introduction

1. Intended Use

To sterilize medical products using low temperature plasma.

2. Sterilization principle

The diffused hydrogen peroxide gas molecules (H2O2) are decomposed in the plasma state and
generate OH & OH2 (Hydroxyl & Hydroperoxyl Radical), which is an anion with excellent oxidizing
power. This hydroxyl group has a property of binding with hydrogen (H +) which is a cation of the
cell membrane of microorganisms and becoming water. At this time, the cell membrane which
lost the hydrogen is destroyed, and eventually it is killed. Hydrogen peroxide gas is completely
decomposed into water and oxygen (O2) after sterilization.

3. Before use Checking list

1) Be sure to read the instruction manual.

2) Experts should use it

3) Do not use it for other purposes

Chapter 2. Safety (Cautions and Warning)

1. Safety mark

｜ ○
ON(Supply) OFF(Supply) Protective ground
(Ground)

DC AC
Caution Electrical hazard

High temperature
caution No decomposition No contact Fire hazard

Authorized
Representative in the Stenosis risk High frequency risk
Serial number
EC

Rotation caution High voltage caution Wear protective Wear protective

gloves goggles

Manufacturee Date of manifactured Follow instruction

No recycling
For use
2. Safety and packaging box marked

Moisture caution Do not use hooks Handle with care Top indication

3. Materials that can be used in plasma sterilizers

METALS

Aluminum 6,000series

Stainless Steel 300series

Titanium

NON METALS

Acrtlonitrille-butadiene-styene(ABS) Polycarbonate

Delrin Polyetherimide

EVA(Etheyl vinyl acetate) Polyethylene terephthalate(PET)

Fluorinated ethylene propylene(PFTE) Poly methyl methacrylate(PMMA)

Glass, USP Type 1 Borosilicate Poly(Phenyl sulfone)

High density polyethylene Polypropylene

Kraton Polystyrene

Latex Polysulfone

Low denisty polyethylene Polyterafluroethylene(PTFE)

Monel Polyurethane

Neoprene rubber(Polychloroprene) Polyvinyl choride(PVC)

Nylon Silicone

Phenolic resin
4. Materials that can not be used in plasma sterilizers

1) Absorbing materials (Fiber)

wood, textile, paper(count sheet), sponge and Other disposable materials

2) Liquid (moisture)

3) Powder
Chapter 3. Specifications

1. Product name and class

1) Item

Lowtemperaturplasma -Sterilisator.

2) Name

ZEUS-130S

3) Protection against electric shock and degree of protection.

Class 1 devices, B Type Device

2. Shape, structure

1) Appearance

① Main body

Front Rear

Left side Right side

② Accessories and cunsumables

Sterilizing agent Incubator

Biological indicator (BI) Chemical indicator strip(CI)

Chemical indicator tape Pouch

 Non-woven Soft lumen(single)

Soft lumen(double) Stainless lumen

2) Appearance discription

Front Rear

Front Top
Left side Right side
No. Name Explanation

It shows the status of all sterilization processes and systems and is used to control fully
A Touch PC
automated sterilization processes.

B Feeder door A device for inserting and removing a cassette, which is sterilizing agent.

Device for outputting the time, alarm, error occurrence, and related contents of the
C Printer
sterilization process on printer paper.

D Chamber door A device for injecting and removing medical devices intended to be sterilized.

A switch that supplies or disconnects power to the monitor, printer, and scanner in the
E ON/OFF switch
sterilizer.

F USB Socket Devices used to transfer data.

G LAN Socket Communication device.

H Speaker A device that starts and ends the process and outputs an error and alarm to the sound.

I Power cord insert Power cord connection opening.

J Main power breaker Device that supplies or disconnects the main power of the equipment.

K Pump Oil window A window showing the amount of oil in the pump.

L Fan Apparatus for discharging air out of the sterilizer.

3) Exterior main parts

① Major parts

Sterilization chamber Vacuum pump

Feeder Plasma chamber

No. Name Explanation

Sterilization
1 A container for sterilizing a sterilized object to be sterilized.
chamber

An apparatus for removing air from a sterilization chamber to form and

2 Vacuum pump
maintain a vacuum.

3 Feeder An apparatus for supplying a cassette which is sterilizing agent.

It is located at the bottom of the sterilization chamber, and when converted

from the diffusion stage of the sterilization process to the vacuum stage,
4 Plasma chamber generates plasma to generate OH radicals, thereby improving sterilization
power and decomposing hydrogen peroxide into a trace amount of oxygen
and water.
② Sterilization chamber

Designation Description

A Internal temperature TC For measuring chamber internal temperature

Hydrogen peroxide Move the hydrogen peroxide in the vaporizer to the

B
injection valve chamber.

C Vent Valve Vacuum maintenance between chamber and pump

D Vacuum gauge For measuring chamber internal pressure

E Plasma Housing Confirmation of plasma generation

F Spare Compared with vacuum gauge when testing vacuum

③ Internal structure

Front Internal

Left side Backside

No. Name Explanation

1 Cassette Apparatus for storing sterilizing agents.

2 Carburetor Mechanism to vaporize sterilant.

3 Sol Valve A valve that injects sterilant into the chamber.

4 Vent Sol Valve A valve that injects air into the chamber.

5 Vacuum Sol Valve A valve that turns ON / OFF between the chamber and the pump.

6 Heater Apparatus for supplying heat to the apparatus.

7 CDS A sensor that detects the light in the plasma chamber.

8 Gauge An instrument that shows vacuum pressure in the chamber.

 4) Accessories and cunsumables

In order to confirm the sterilization performance of this product, the following indicators and

devices should be used according to the characteristics of the product.

Sterilizing agent Incubator

Biological indicator(BI) Chemical indicator strip(CI)

Chemical indicator tape Pouch

 Non-woven Soft lumen(single)

Soft lumen(doublel) Stainless lumen

No. Name Explanation

1 Sterilizing agent A sterilizing agent which is sterilized in a sterilization chamber.

2 Incubator It is used to cultivate BI (Biological Indicator) after sterilization

process.
After sterilization with the biological indicator used to confirm the
Biological indicator sterilization process, the sterilization is determined by bacterial culture.
3 It consists of Bacillus Stearothermophilus and culture solution. After the
(BI)
sterilization process, it is incubated in an incubator to check the
progress of the process by color change.
It is a chemical indicator used to check whether there is exposure
Chemical indicator of the sterilizing agent hydrogen peroxide during the sterilization
4 process. When hydrogen peroxide is activated on the surface, it
strip(CI)
becomes discolored to pink when exposed, so that it is possible
to confirm the abnormality during the sterilization process.
When the sterilization process is proceeded with the indicator, it
Chemical indicator
5 changes into pink, so that the medical instrument is sterilized or
tape the sterilization process is normally performed, and it can be
visually confirmed.

It is a wrapping paper for packaging medical instruments. It is used

6 Pouch for long-term storage after sterilization. One side is made of vinyl
and the other side is made of non-woven fabric.

7 Non-woven Used to pack medical devices directly or to pack medical devices

in baskets.
Soft lumen(single)
8
Soft lumen(double) It is used to test the sterilization performance of the sterilizer. It is
composed of Teflon soft lumen and stainless steel hard lumen.
9 Stainless lumen
3. Dimensions

1) Appearance Dimensions

① Overall dimensions (Horizontal×Height×Vertical, mm) : 720×1650×900

2) Chamber dimensions

① Outer dimensions (Horizontal×Vertical×Depth, mm) : 570×440×770, 12t

② Internal Actual Use : 134L

- Internal dimensions (Horizontal×Vertical×Depth, mm) : 420×420×760

③ Effective volume : 130L

- Shelf dimensions (Horizontal×Depth, mm) : 350×680

- Number of shelves and Allowed height : 2단, 210mm

Name Explanation

A Internal temperature TC For measuring chamber internal temperature

Hydrogen peroxide
B Move the hydrogen peroxide in the vaporizer to the chamber
injection valve

C Vent valve Vacuum maintenance between chamber and pump

D Temperature gauge For measuring chamber internal pressure

Plasma Housing
E Confirmation of plasma generation
Vacuum gause

F Redundancy Reserve
3) Door dimensions

① Dimensions (Horizontal×Height×Thickness, mm) : 500×492×20

4) Weight : 350kg
5) Accessories and cunsumables

Appearance Name Dimensions Weight Unit

2ml x 12/cassette
Sterilizing
W 24Cm 250g 1Set
agent
D 7Cm
H 2Cm

W 13Cm
Incubator D 9.5Cm 6.5Kg 1Set
H 7.1Cm

Biological 100ea/BOX
indicator H 4.9Cm 2.5g ea
(BI) - Ø1*8.7mm

Chemical
250ea / PACK
Indicator
W 101.1mm 0.44g ea
Strip
D 20.75mm
(CI)

Chemical
50ea / BOX
Indicator 150g ea
19.44mm X 55M
tape
Appearance Name Dimensions Weight Unit

1
Pouch 150mm X 200M 3Kg
Roll

Non- 75ea / BOX

40g ea
waven 60 x 60Cm

Soft lumen Soft Lumen

100g 1Set
(Single) - Ø1*2,000mm

Soft lumen Soft Lumen

200g 1Set
(Double) - Ø1*12,000mm

Stainless Stainless Lumen

50g 1Set
lumen - Ø1*500mm
4. Label

5. Environmental condition

1) Storage, movement, operating conditions

Humidity : 30 ~ 75%

Atmospheric pressure : 70 ~ 106KPa

Temperature : 10 ~ 40℃
Chapter 4. Installation

1. Unpacking

1) Remove the Corrugated Cardboard.

2) Remove the PF-FOAM.

3) Packing dimensions(W x H x D) - 1,400 x 1,950 x 1200

2 Installation and Environment

1) It must be installed and used indoors.

2) Input power fluctuation tolerance: Within ± 10% (Must be Class 1 ground)

3) Temperature: 10 ~ 40℃

4) Relative humidity: 30 ~ 75%

3. Move

In case of movement of the sterilizer, move the wheel after locking the wheel as shown below

[Unlocked]] [Locked]

4. Installation

1) Move to the installation location.

2) Remove the plastic wrap.

3) Remove the Tough Screen Protector.

4) Turn on the main switch on the left side of the equipment.

5. Vacuum exclusion

Press the MENU button.

Press the VENT button to release the vacuum in the sterilization chamber.

Press the DOOR OPEN button to see if the chamber door opens.
6. Equipment TEST

Press the MENU button.

Select STERILIZING AGENT MODE.

Press BAR CODE SCAN to check the SCANNER operation and memory status.

When the BAR CODE is normal, relevant information is automatically recorded.

 Select SYSTEM MODE.

ERROR CHECK : Checked items are automatically managed

when the sterilization process is in progress.

PRINTER : Select AUTO, COPY 1.

Select OPTION and select Torr and select ℃.

SYSTEM : Speaker volume setting, LED on door,

ON Language Select English.

DATE ＆ TIME : Select date and time notation.

Press the START button in the LEAK TEST MODE to test the unit.

Check the MAX VACUUM TEST and LEAK UP RATE TEST results,

and if it is PASS, press the printer button to output the test result.
Press the START button in TEMPERATURE TEST MODE to check the temperature.

When the temperature result is PASS, press the PRINT button to display the test result.

In PART TEST MODE, press the START button to check the status of each solenoid valve.

If the sol valve result is PASS, press the printer button to output the test result.
Press the PARTS TEST button in MAINTENANCE MODE.

Press each button to confirm that the button operates according to the button.

Press the PM SCHEDULE button to set the cycle for the item.

After setting, press SAVE button to save

Press the CALIBRATION button to set the temperature and pressure,

and press the SAVE button to save.

Check that the temperature is correct.

Press SELECTION button to record each item and press SAVE button to save.

Make sure that the information recorded in the SELECTION

in the INFORMATION in the SETTING & INFORMATION MODE is displayed.

Set the contents related to each item in FACTORY SETTING MODE and

press the ALL SAVE button to save the setting contents.

7. Warm-UP

For normal use, equipment should be used after more than 4 hours of preheating.

Use the equipment when the temperature inside the chamber inside the monitor

is 50 ° C or higher.

8. Storage and management method

1) Storage conditions

① Store in a place where there is no possibility of affecting the sterilizing

device by air containing air pressure, temperature, humidity, ventilation, sunlight,

dust, salt and ion.

② Storage environment

Humidity : 30 ~ 75%

Atmospheric pressure : 70 ~ 106KPa

Temperature : 10 ~ 40℃

③ Keep it in a safe place from slope, vibration and impact.

④ Avoid storing chemicals or generating gas.

2) How to keep and manage after use.

① To store the equipment, set the chamber pressure to 0.5 Torr,

turn off the switch button at the center of the front of the equipment and turn off the main power.

② Store in a place where there is no possibility of affecting the sterilizing

device by air containing air pressure, temperature, humidity, ventilation, sunlight, dust, salt and ion.

③ Keep it in a safe place from slope, vibration and impact.

④ Avoid storing chemicals or generating gas.

⑤ Clean it thoroughly so that it will not interfere with use next time.

⇒ Clean the exterior with a soft cloth. If contamination is severe,

wipe it with a little alcohol or acetone.

⑥ In the event of a malfunction, discontinue use immediately and contact

an expert.

⑦ Do not disassemble, repair or modify the system by anyone other than

a skilled person.
Chapter 5. Operation

1. Preparation before use

1) Do not connect MAIN power during installation for safety.

2) Equipment should be installed and tested according to the manufacturer's installation method.

3) Check operation manual and user manual, and be sure to read manual before use.

4) Install the product so that it is always level.

5) Check that the door of the sterilization chamber is closed.

6) Connect main power plug.

7) Turn on the AC power on the back of the equipment. (Be sure to preheat for 3 hours.)

8) After applying the power, check if the main mode is displayed on the Touch PC,

Verify that the valves are operating.

9) If the preparation status is displayed, execute a sequential command through the monitor.

10) Execute Self Test to check whether the equipment operates normally.

2. Operating method

1) Turn on the unit with the ON / OFF switch in the center of the unit.

2) Make sure that the following main screen appears.

3) Insert sterilizer (cassette)

① Check the bar code label before inserting the cassette.

② Check if the capsule contained in the cassette is leaking.

4) Sterilizer input method

① Open the door of the feeder and push the cassette

② Check the shape of the capsule in the cassette, insert the cassette, and close the feeder door.

(The bottom of the capsule in the cassette is facing the bottom)

5) Press the "MENU" button on the main screen.

In the SETTING & INFORMATION mode, press the STERILIZING AGENT button.

Press the BARCODE SCAN button to read the BAR CODE attached to the cassette.

When the bar code in the cassette is READING, the capsule appears on the left capsule screen.
 6) REMAINING CAPSULE : 12/12

EXPIRY DATA : 2017. 12. 30

REMAINING DAY : 2017. 05. 10

STERILANT S/N : 82YYMMDD00C

If the SCAN is normally done, it is recorded in the upper right corner of the screen as above.

3. Running the automatic process

1) Check the chamber internal temperature (over 50 ℃) and the sterilant count on the main screen.

2) Open the chamber door and place the medical device in the basket. Close the chamber door.

3) If the sterilization process button is pressed, the sterilization process proceeds and the monitor screen

appears.

4) If the monitor pressure and temperature graph are displayed in real time,

Process, remaining time, pressure, chamber temperature, total number of uses, and number of uses on

that day.
 5) When the sterilization process is completed, the voice guidance and the sterilization process record to

inform completion are output to the printer. After the sterilization is completed, the chamber door is

opened, the basket is taken out, and the medical instrument is taken out.

4. TOUCH PC screen button description (MAIN screen)

1) MONITORING: Switching between process screen and process graph screen

2) MENU: Switch to next screen

3) OPEN: DOOR LATCH is canceled.

4) LOGIN: User and PASSWORD registration

5) STANDARD: Start general sterilization process.

6) ADVANCED: The medical device is complicated or starts a large amount of sterilization process.
5. TOUCH PC screen button description (MONITORING)

1) Graph: Graphs the temperature and pressure inside the chamber.

2) Process: Displays the section that is operated by process by time.

3) USER: Displays the equipment user.

4) PROGRESS: Displays the selected sterilization process. (Three sterilization processes)

5) REMAINING TIME: Displays the remaining time of the sterilization process.

6) PRESSURE: Displays the pressure of the sterilization process in real time.

7) TEMPERATURE: Displays the chamber temperature in real time.

8) CYCLE TOTAL: Displays the number of total usage of the equipment.

9) DAILY: Displays the number of use on that day.

10) REMAINING: Displays the quantity of capsule used.

11) HOME: Press button to move to main screen.

12) CANCLE: Press the button to cancel the process.

6. TOUCH PC screen button description (SETTING & INFORMATION)

1) TRAY HEATER TOP: Top power of tray heater

2) TRAY HEATER BOTTOM: Power supply at bottom of tray heater

3) STERILIZING AGENT: Presence or absence of sterilizing agent

4) PRINTER AUTO & MANUAL:

AUTO: Automatic printer output after the process

MANUAL: Check whether the printer is printing after the process

5) COPY: Printer is output after the set number

6) OPTION: Check whether the printer displays temperature and graph

7) VOLUME: Speaker volume adjustment for audio output

8) LED ON / OFF: LED power ON / OFF selection

9) LANGUAGE: Select language

10) DATE FORMAT: Select date format

11) TIME FORMAT: Select time format

12) SYSTEM TIME: Touch PC time setting

13) SETTING: Set the setting to SETTING

14) PRINT: Output the setting to printer

15) MENU: Go to next page

7. How to keep and manage after use

1) When the sterilization process is completed, make vacuum in the sterilization chamber, turn off the power

switch at the center front of the sterilizer, and turn off the main power switch at the back of the sterilizer.

2) Store in a place where there is no possibility of affecting the sterilizer by air containing air pressure,

temperature, humidity, ventilation, sunlight, dust, salt and ion.

3) Store in a safe place from inclination, vibration and impact.

4) Avoid storing chemicals or generating gas.

5) Clean the inside and outside of the sterilizer with a soft cloth.

6) In the event of a malfunction, discontinue use immediately and contact the specialist.

7) Do not disassemble, repair or modify the system by anyone other than an expert.
Chapter 6. Routine Maintenance

1 Routine check

1) When the sterilization process is completed, make vacuum in the sterilization chamber, turn off the power
switch at the center front of the sterilizer, and turn off the main power switch at the back of the sterilizer.

2) Store in a place where there is no possibility of affecting the sterilizer by air containing air pressure,
temperature, humidity, ventilation, sunlight, dust, salt and ion.

3) Store in a safe place from inclination, vibration and impact.

4) Avoid storing chemicals or generating gas.

5) Clean the inside and outside of the sterilizer with a soft cloth.

6) In the event of a malfunction, discontinue use immediately and contact the specialist.
Chapter 7 Trouble Shootings

1. Error message

No Displayed Message User’s action

Wait for the process is over.

ERROR-1 Cycle Cancel. After the process finish, open the door.
Please re-sterilize the items.

Select PARTS TEST Mode in maintenance.

Check the Cassette motor
ERROR-2 Press the SHS and SFS Buttons in the SM to check the motor movement and the
Home sensor. related sensor detection status in the driver board.

Select PARTS TEST MODE in maintenance.

Check the Syringe motor
ERROR-3 Press CHS and CFS buttons in CM to check motor movement and related sensor
Home sensor. detection status in driver board.

Select PARTS TEST MODE in maintenance.

Check the Syringe motor
ERROR-4 Press CHS and CFS buttons in CM to check motor movement and related sensor
Front sensor. detection status in driver board.

Select PARTS TEST Mode in maintenance.

Check the Cassette Transfer
ERROR-5 Press the THS and TFS buttons in the TM to check motor movement and related
Motor Home sensor. sensor detection status in the driver board.

Select PARTS TEST MODE in MAINTENANCE.

After confirming the VT temperature, if it is lower than the set temperature, press the
Check the Vaporizer
ERROR-6 VT button to check temperature rise and fall
Temperature. Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

When an error occurs during pump operation

Checking EOCR sensor detection in MAINTENANCE PART TEST mode.
ERROR-7 Check the Pump Current. Check pump operation status.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

The initial vacuum level has not been reached.

Perform a LEAK TEST in Test Mode.
ERROR-8 Check the Vacuum.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

The second vacuum level has not been reached.

Perform LEAK TEST in LEAK TEST Mode.
ERROR-9 Check the V1 Vacuum.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Check the inject syringe hole.

Check that the syringe motor is operating normally.
ERROR-10 Check the I1D1 Vacuum. Check the sterilant in ample of cassette.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr
 Perform LEAK TEST in LEAK TEST Mode.
ERROR-11 Check the V2P1 Vacuum. Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Check the inject syringe hole

Check that the syringe motor is operating normally.
ERROR-12 Check the I2D2 Vacuum Check the sterilant in ample of cassette.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Perform LEAK TEST in LEAK TEST Mode.

ERROR-13 Check the V3P2 Vacuum. Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Check the inject syringe hole.

Check that the syringe motor is operating normally.
ERROR-14 Check the I3D3 Vacuum. Check the sterilant in ample of cassette.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Perform LEAK TEST in LEAK TEST Mode.

ERROR-15 Check the V4P3 Vacuum. Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Check the inject syringe hole.

Check that the syringe motor is operating normally.
ERROR-16 Check the I4D4 Vacuum. Check the sterilant in ample of cassette.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

Perform LEAK TEST in LEAK TEST Mode.

ERROR-17 Check the V5P4 Vacuum. Contact the Medonica Co., Ltd customer service center.
service@medonica.kr

After vacuum forming in MAINTENANCE PART TEST Mode, Press the HVT button to
check if plasma is generated in the plasma housing Confirmation of CS detection in
ERROR-18 Check the Plasma. PART TEST Mode after Plasma occurrence.
Contact the Medonica Co., Ltd customer service center.
service@medonica.kr
2. Equipment Alarm

No Displayed Message User’s action

The power inside the equipment has been cut off.

ALARM-1 Power Outage.
Occurs when power is supplied.

Check chamber door closed status.

Check the Chamber Check DCM Detection in PART TEST Mode of maintenance.
ALARM-2
Door Sensor. Contact the Medonica Co., Ltd
customer service center. service@medonica.kr

MAINTENANCE PART TEST

Check PR1 gauge vacuum pressure in PART TEST mode in MAINTENANCE.
Check the Chamber Press the VENT button to set the vacuum level in the chamber to atmospheric
ALARM-3
Pressure. pressure to check the vacuum level.
Contact the Medonica Co., Ltd
customer service center. service@medonica.kr

Check the safety bar in Door.

Check the Door Pressure
ALARM-4 Check DDPS Detection in PART TEST Mode of maintenance
Safety Sensor. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check the door safety swich

Check the Door Safety
ALARM-5 Check DPS Detection in PART TEST Mode of maintenance
Switch. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check the foot sensor.

ALARM-6 Check the Foot Sensor. Check DFS Detection in PART TEST Mode of maintenance.
Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check the cassette door closed status in the injection parts.

Check the Cassette Door
ALARM-7 Check CDM Detection in PART TEST Mode of maintenance.
Switch. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

After insert cassette to injection.

Check the Cassette Front part, check the detect of switch.
ALARM-8
Switch. Check CDMF Detection in PART TEST Mode of maintenance.
Contact the Medonica Co., Ltd customer service center. service@medonica.kr

After insert cassette to injection part, check the detect of switch.

Check the Cassette Back
ALARM-9 Check CDMB Detection in PART TEST Mode of maintenance.
Switch. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check the cassette for barcodes.

Check bar code operation status.
Cannot sense the Bar
ALARM-10 Press SCAN button to check bar code LED operation status in PART TEST Mode
code. of maintenance.
Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Verify the serial number of the Bar Code.

ALARM-11 Duplicated Bar code. Replace the hydrogen peroxide cassette with a valid cassette.
Repeat the Bar Code scanning process again.

ALARM-12 30 Day Expired Sterilant. Replace the 30 day-passed hydrogen peroxide cassette with a new cassette.
 Replace 1 year passed hydrogen peroxide cassette with
ALARM-13 1 Year Expired Sterilant.
a new cassette.

Sterilant Cassette is When the capsule count in the cassette is 0 or 3 at the start of the process.
ALARM-14
Empty. Replace empty hydrogen peroxide cassette with a new cassette.

Check temperature rise or fall to press DT button in PART

Check the Door
ALARM-15 TEST Mode of maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check temperature rise or fall to press CT button in PART TEST

Check the Chamber
ALARM-16 Mode of maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check temperature rise or fall to press CBT button in PART TEST Mode of
Check the Chamber Back
ALARM-17 maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check temperature rise or fall to press VT button in PART TEST

Check the Vaporizer
ALARM-18 Mode of maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check temperature rise or fall to press TTB button in PART TEST Mode of
Check the Tray Bottom
ALARM-19 maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check temperature rise or fall to press TTB button in PART TEST Mode of
Check the Tray Top
ALARM –20 maintenance.
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

Check the Chamber Inner Check CIT temperature in PART TEST Mode of maintenance.
ALARM –21
Temperature. Contact the Medonica Co., Ltd customer service center. service@medonica.kr

PM1 Change the Carbon Over the Carbon Filter usage cycle.
ALARM –22
Filter. Change to Carbon HEPA Filter.

PM1 Change the HEPA Over the HEPA Filter usage cycle .
ALARM –23
Filter. Change to HEPA Filte.

PM1 Change the Oil Mist Over the Oil Mist Filter usage cycle.
ALARM –24
Filter. Change to Oil Mist Filter.

Over the Pump Oil usage cycle.

ALARM –25 PM1 Change the Pump Oil.
Change to Pump Oil.
 PM2 Change the Plasma Over Plasma Assembly usage cycle.
ALARM –26
Assembly. Change to Plasma Assembly.

Cassette overflow in cassette box.

ALARM –27 Change the Cassette Box.
Drop Cassette Present in cassette box.

3. Other messages

No Displayed Message User’s action

Please contact the

1 Insert mobile no.
number for HELP.

You have selected the

2 Do you want to continue?
SHORT process.

You have selected the

3 Do you want to continue?
STANDARD process.

You have selected the

4 Do you want to continue?
ADVANCED process.

The sterilization process is complated

5 CYCLE PASS.
normally.

6 REPLACE CASSETTE. Will you replace the cassette?

Do not have the right to

7 Please select the process after LOGIN.
execute the process.
Chapter 8 Purchase of consumables and A / S

1. A list of consumables and purchase route

No. Name Purchase route

1 Sterilizing agent

2 Incubator

3 Biological indicator (BI)

4 Chemical indicator (CI)

5 Chemical indicator tape Contact the manufacturer.

6 Pouch

7 Non-woven

Soft lumen(single)
8
Soft lumen(double)

9 Stainless lumen
 2. A / S Description

※ For other inquiries, please contact our office or your dealer.

e-mail : info@medonica.com

telephone : (82)31-283-0231

fax : (82)31-283-0243

3. Warranty

1) Warranty – 2 years.

2) Product Life - 10 year as a basis.

3) Replacement cycle time for each part

Check Point
Unit Cycle Description
Check Replace Calibration

Pump oil 600 Vacuum Pumo oil √ √ -

Oil Mist Filter 600 Mist Filter √ √ -

Carbon Filter 600 Smell removal Filter √ √ -

Hepa Filter 1,200 Bacteria Filter √ √ -

High Voltage Plasma

Plsma Electrode 1,200 √ √ -
Electron
 Chapter 9 Electromagnetic Compatibility

1. EMC

This equipment has been tested and found to comply with the limits for medical devices in EN60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical
installation.

This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation.

If this equipment does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:

- Reorient or relocate the receiving device.

- Increase the separation between the equipment.

- Connect the equipment into an outlet on a circuit different from that to which the other device(s) are
connected.

- Consult the manufacturer or field service technician for help.

 9.1.1 Electromagnetic Emission

The product is suitable for use in an specific electromagnetic environment. The customer and/or the user
of the product should assure that it is used in an electromagnetic environment as described below.

Electromagnetic Environment
Emission Test Compliance
Guidance

RF-emission Group 1 The product use RF energy only for its

CISPR 11 internal function. Therefore, its RF

emissions are very low and not likely to
cause any interference in nearby
electronic equipment.

RF-emission Class A The product is suitable for use in all

CISPR 11 establishments, including domestic

Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
establishments and those directly
Class A
connected to the public low-voltage
power supply network that supplies
complies buildings used for domestic purpose.

9.1.2 Electromagnetic Immunity

The product is suitable for use in a specific electromagnetic environment. The customer and/or

the user of the product should assure that it is used in an electromagnetic environment as

described below.

Immunity Test IEC 60601- Compliance Electromagnetic Environment

Level Level Guidance

Electrostatic ± 6kV contact ± 6kV contact Floor should be wood, concrete or

discharge(ESD) ± 8kV air ± 8kV air ceramic tile. If floors are covered with
IEC61000-4-2 synthetic material, the relative humidity
should be at least 30 %

Electrical fast ± 2kV for ± 2kV for Mains power quality should be that of
transient/bursts power power a typical commercial and/or hospital
IEC61000-4-4 supply lines supply lines environment
± 1kV for ± 1kV for
input/output input/output
lines lines
Surge ± 1kV ± 1kV Mains power quality should be that of
IEC61000-4-5 differential differential a typical commercial and/or hospital
mode mode environment
± 2kV common ± 2kV common
mode mode

Immunity Test IEC 60601- Compliance Electromagnetic Environment

Level Level Guidance

Voltage dips, <5% UT <5% UT Mains power quality should be that of

short (>95% dip in (>95% dip in a typical commercial and/or hospital
interruptions UT) for 0.5 UT) for 0.5 cycle environment. If the user of the product
and voltage cycle 40% UT requires continued operation during
variations on 40% UT (60% dip in UT) power mains interruptions, it is
power supply (60% dip in UT) for 5 cycles recommended that the product be
input lines for 5 cycles 70% UT powered from an uninterruptible power
IEC61000-4-11 70% UT (30% DIP IN UT) supply or a battery.
(30% DIP IN UT) for 25 cycles
for 25 cycles <5% UT
<5% UT (>95% dip in
(>95% dip in UT) for 5 sec
UT) for 5 sec

Power 3A/m 3A/m Power frequency magnetic fields

frequency should be at levels characteristic of a
(50/60 Hz) typical location in a typical
magnetic field commercial or hospital environment.
IEC 61000-4-8
 Portable and mobile RF
communications equipment should be
used no closer to any part of the
product, including cables, than the
recommended separation distance
Conducted RF 3 Vrms 3 Vrms calculated from the equation
IEC 61000-4-6 150 kHz applicable to the frequency of the
to 80 MHz transmitter.

Recommended separation distance:

d = 1.2√P
Radiated RF 3V/m 3 V/m
IEC 61000-4-3 80 MHz d = 1.2√P
to 2.5 GHz for 80 MHz to 800 MHz

d = 2.3√P
for 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in Watt (W)
according to the transmitter
manufacturer and d is the re-
commended separation distance in
meters (m) Field strengths from fixed
RF transmitters, as determined by an
electromagnetic site survey a, should
be less than the compliance level b in
each frequency range Interference
may occur in the vicinity
of equipment marked
with the symbol
described lateral.
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, people and animals.
 a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered, if the measured
field strength in the location in which the product is used exceeds the applicable RF compliance
level above, the product should be observed, additional measures may be necessary, such as
reorienting or relocating the product.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

9.1.3 Recommended Separation Distances between portable and mobile HF- communications equipment
and the product

The product is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the product can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the product – according on output power and frequency of the communications equipment – as
recommended in the following table.

Rated maximum Separation distance according to the frequency of transmitter

output power of in meter (m)

transmitter in watts 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
(W) d = 1.2√P d = 1.2√P d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

Note 1: At 80 MHz and 800MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects, people and animals.

Chapter 10 Disposal
1. Instructions for disposal procedure

1) If this equipment has completed its useful service life, it can be returned to manufacturer or can be
disposed by the user in compliance with the local environmental regulations.

2) In case of the return to the manufacturer, the whole parts of the equipment or some parts of the
equipment can be returned.

3) In case that the equipment is decided to be disposed by the user, it will be ideal to dispose the
equipment after disassembly of the equipment to the proper level.

4) Disposal of old Electrical & Electronic Equipment

(Application in the European Union and other European countries with separate collection system.)

This symbol indicates that this product shall not be treated as household waste. Instead, it shall be handed
over to the applicable collection point for the recycling of electrical and electronic equipment. By ensuring
this product is disposed of correctly, you will help prevent potential negative consequences for the
environment and human health, which could otherwise be caused by inappropriate waste handling of this
product. For more detailed information about recycling this product, please refer to local governing
ordinances and recycling plans.