1412-RENO - S130 Service Manual (R12) [PDF]

Zitiervorschau

0120

SERVICE MANUAL [RENO-S130]

RESM-004(Rev.12)

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RENOESM CO., LTD.

Copyright © 2010 RENOSEM CO., LTD. All rights reserved. Edit : 2014. 12

Table of contents:

Chapter 1: Introduction Introduction----------------------------------------------------------------------------------- 4 1.

Caution Prior to Use -------------------------------------------------------------------

5

2.

Safety Symbols --------------------------------------------------------------------------- 6

3.

Sterilization Load ------------------------------------------------------------------------

7

Chapter 2: Explanations of the System 4.

RENO-S130 Configuration and Names of Parts -------------------------------- 8 1) Names and Specification of Parts --------------------------------------------------- 8 2) Accessory --------------------------------------------------------------------------------- 10 3) Sterilization Cycle ----------------------------------------------------------------------- 12

5.

RENO-S130 System Procedures ---------------------------------------------------- 14 1) Explanations on Processing Cycles and Displays ----------------------------- 14 (1) Injecting Hydrogen Peroxide ---------------------------------------------------

14

(2) Self-Test Mode --------------------------------------------------------------------

15

(3) User Mode --------------------------------------------------------------------------

15

(4) Adjust the Date and time on the screen ------------------------------------- 18 (5) Maintenance Mode ---------------------------------------------------------------- 19 (6) Monitor Mode ----------------------------------------------------------------------

21

2) Deal Drawing of the Device ---------------------------------------------------------- 22 RESM-004(Rev.12)

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RENOESM CO., LTD.

3) Understanding of Each Part‟s Name and Measures--------------------------- 23 4) PM cycle ------------------------------------------------------------------------------------ 31 6.

Error Mode ---------------------------------------------------------------------------------

32

1) Error Mode ---------------------------------------------------------------------------------

32

2) Trouble shooting --------------------------------------------------------------------------

34

Chapter 3: Installation of Products 7.

RENO-S130 System Installation-----------------------------------------------------

37

1) Introduction ---------------------------------------------------------------------------------- 37 2) Unpacking ----------------------------------------------------------------------------------- 37 3) Installing Environment -------------------------------------------------------------------- 40 4) Checking after Installation --------------------------------------------------------------- 41 5) Caution for Installation -------------------------------------------------------------------- 41

Chapter 4: Diagram for System 8.

System Diagram --------------------------------------------------------------------------- 42 1) Introduction ---------------------------------------------------------------------------------- 42 2) Mechanic System -------------------------------------------------------------------------- 42 3) Electric System ----------------------------------------------------------------------------- 52

9. Statement of Conformity --------------------------------------------------------------------- 56 10. Labeling ------------------------------------------------------------------------------------------ 57

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RENOESM CO., LTD.

Chapter 1: Introduction Introduction RENO-S130 is used for the purpose of sterilizing operational and medical tools by using plasma and sterilant within low temperatures. Medical tools that are sensitive to heat and humidity are most suitable for sterilization because the operation temperature is low (below 55℃). Details are displayed on the touch panel while processing and can be easily checked. Once the sterilization process is complete, details are printed out so results can be easily verified. Reading the Operating Manual prior to using RENO-S130 will be helpful for safety and effective sterilization.

CAUTION: This manual provides information on the safe operation of RENO-S130. Read this manual carefully prior to using RENO-S130 and follow the instructions upon use.

Specifications Category Chamber

Function (Specification)

Capacity

130 liters

Material

Stainless Steel (STS 304)

Sterilizing Temperature Sterilizing Pressure

Sterilization Time (28min ~ 67min)

Total cycle

Below 55℃

Initial cycle

Below 20 Torr

Diffusion cycle

Above 20 Torr

Cycle/ Program

Advanced

ECO

Non-lumen

Initial cycle

9-12 Min

5-9 Min

5-7 Min

Sterilization cycle I

22~24 Min

15-19 Min

8-10 Min

Sterilization cycle II

20~22 Min

12~16Min

8~10Min

Complete cycle

7~9 Min

5~9 Min

5~9 Min

Sterilant (Sterilization Agent) Rated Voltage

Hydrogen Peroxide (50%) Single phase 200V, 230V ~ 50/60Hz Vacuum pump motor Changed by 50/60 Hz

Power Consumption

3 KW

Max current

30A

Dimensions

RESM-004(Rev.12)

Model (liter)

RENO-S130 (130L)

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RENOESM CO., LTD.

W x H x L (mm)

778.4 x 1,547 x1,120 / 440

Weight (kg) High-Voltage Trans

Specification

220V, 200W, 60Hz

1. Caution Prior to Use 1) Cautions on Sterilant Agent Hydrogen peroxide used as sterilant is a strong irritant to the skin, eyes, nose, throat, lungs and alimentary tract, and also has a rapid seepage force. When you use the sterilant, you must wear safety gloves (latex or vinyl gloves) or waterproof gloves to handle it. Empty containers must be thrown away at designated places. Upon contact with the human body due to negligent handling, immediately wash off with water. If ingested, immediately drink high volumes of water and follow instructions given by a medical physician. If the equipment stops due to malfunction during the sterilization process or if water remains on the sterilization target after the process has completed, such indicates that hydrogen peroxide remains on the sterilization target. Wear safety gloves (latex or vinyl gloves) or waterproof gloves and protection glasses to handle it and do not touch your face or eyes with the gloves. 2) A person authorized by Renosem Co., LTD. may move the equipment from its initially installed place to another. Contact Renosem Co., LTD. and receive appropriate instructions when restarting use of the equipment after a prolonged period of disuse. 3) Wash and dry out sterilized materials completely. Organic matters or visible dirt may hinder sterilization. Additionally, quantities of moisture within sterilized material may delay the processing time, resulting in processing errors. 4) Check whether it is being sterilized by inserting the CI (Chemical Indicator) strip each time the sterilization process is conducted. Check whether sterilization performance is satisfactory with the BI (Biological Indicator) at least once a week with sterilizing and then incubating. 5) Accessories and consumables (BI, CI Strip, CI Tape, Pouch, Non-Woven, Incubator, and Instrument Tray) must be provided or approved by Renosem Co., LTD. 6) Do not unplug the power cord or turn off the main breaker during the sterilization process. 7) Components requiring maintenance must be replaced according to the PM Cycle as described within the service guide. (There are components that require inspection or replacement after 600 cycles, 2400 cycles or at least once a year. Check the PM cycle to receive maintenance by contacting RENOSEM or your place of purchase.) 8) Do not touch the equipment with wet hands.

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9) Conduct the sterilization process again upon the occurrence of abnormal sterilizations (example: Power off, occurrence of errors, unchanged indicator colors, etc.)

Definition Symbols Found On RENO Sterilizer

2. Safety Symbols RESM-004(Rev.12)

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Do Not Dissemble

Do Not Touch With Wet

Danger! Strong

Danger! Corrosive

Danger! Hands

Hands

Oxidizing

Substances

Cutting In

KS A 3501

KS A 3501-3.4

ISO 3864 B3.6

Danger!

Danger!

Wear Protective

Wear Protective

Revolving Objects

High Voltage

Gloves

Goggles

Electric Safety type B

3. Sterilization Load 1) Compatible materials -

Metal materials (Stainless Steel, Aluminum, Titanium alloys etc.) Plastic products (Polyethylene, Polycarbonate, PVC, PP, Viton etc.) Glass materials Rubber materials (Silicon) Ceramics material

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Advanced cycle - Hard-Lumen: Tool with a tube inside diameter of >1ø mm and up to 1,000mm in length - Soft-Lumen: Tool with a tube inside diameter of >1ø mm and up to 12,000mm in length - Soft-Lumen: Tool with a tube inside diameter of > 2ø mm and up to 1,500mm in length with one end blocked ECO cycle - Hard-Lumen: Tool with a tube inside diameter of >1ø mm and up to 500mm in length - Soft-Lumen: Tool with a tube inside diameter of > 1ø mm and up to 1,500mm in length

-

Soft-Lumen: Tool with a tube inside diameter of > 2ømm and up to 1,500mm in length with one end blocked

2) Uncompatible materials -

Materials that absorb moisture (Paper, Cellulose, cotton textiles, Gauze, wood etc.) Liquid (Oil, Water, Bubble etc.) Disposable products without re-disinfection recommended. (Disposable material and gown) Powder, silk Tool with the moisture (water) Copper and Zinc Acetal (Delrin), Buna N(Nitrile), Brass, Hypalon

3) Materials requiring attention upon sterilization -

Materials to be damaged by High vacuum, such as maker pens, etc. Polyurethane, nylon and plastic of low quality Sponges (Foaming Styrofoam, sponge for protection of microscope, etc.) Some coated products, such as surface coated aluminium, may become bleached or discoloured. Some cable products Some cables may stick to the transparent vinyl of the sterilization roll, pouch. Pack it after wrapping it with sterilization wrap (Nonwoven).

< Cable product >

1

※ Materials with limitations for sterilization: Porous materials, absorptive materials and lumens prevent to produce vacuum and absorb hydrogen peroxide in sterilant and decrease sterilization effect.

Chapter 2: Explanations of the System 4. RENO-S130 Configuration and Names of Parts 1) Names and Specification of Parts

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A C B D F

E

A

Touch panel

Monitors the sterilization process and controls its start and pause

B

Door

Opens/closes to load and unload materials to be sterilized or already sterilized. Seals the chamber during vacuum and higher atmospheric pressure

C

Sterilant Lamp

Blue LED Lamp turns on when the sterilant is supplied

D

Door Lamp

Red LED Lamp turns on when door is closed

E

Printer

After the sterilization process is complete, process details are printed

F

ON/OFF Switch

H

Main breaker

Turns the sterilizing equipment‟s AC main power on and off

I

Power cord

Used to supply power

J

Ventilating Fan

Releases the heat inside the sterilizing equipment

Manual

RESM-004(Rev.12)

Turns the power on and off

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K

Vent Grill

Vents the air inside the machine

L

Chamber

Vessel that contains medical devices for sterilization

M

Sterilant Injection Hole

Injection hole to supply hydrogen peroxide within RENO-SA into the chamber

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2) Accessory (1) Tray Baskets used to conveniently place materials into the sterilization chamber.

(2) Biological Indicator (BI) Biological indicator is a component used to check sterilizing capacity. Sterilized

→ (after incubate) purple color

Not sterilized

→ (after incubate) yellow color

Storage : Room temperature. Do not desiccate and keep away from sunlight. Expiration date : 18 months from Manufacture Date.

(3) Chemical Indicator (CI) Strip & Tape Chemical Indicator (CI) strip & tape that checks whether the sterilant is exposed in the sterilized material.

Color change: Blue

→ (after operation cycle) Pink

Storage : Keep away from sunlight, high temperature and high humidity. Dry condition in re-sealed pouch Expiration date : 24 months from Manufacture Date

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(4) Typek Pouch A packaging material that prevents the contaminated substances from exposure for storing the sterilizing materials for a long period of time (There are composed of width 50, 100, 150, 300 and 400 mm.)

Storage : Keep away from high temperature, high humidity. Dry condition Expiration date : 24 months from Manufacture Date

(5) Sterilant (RENO-SA10) Hydrogen Peroxide Liquid used to sterilize materials to be sterilized. Disposal type Storage : at refrigerator of 0 ~5 ℃. Expiration date : 12 months from Manufacture Date Temperature effects the stability of Sterilant If it stores at room temperature, the shelf life could reduce

(6) Non-Woven Sheet Sheet used to wrap materials to be sterilized that prevent contaminated substances from being exposed into the air. Storage : Keep away from high temperature, high humidity. Dry condition Expiration date : 36 months from Manufacture Date

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RENOESM CO., LTD.

3) Sterilization Cycle (1) General Information There are three sterilization programs, the Non-lumen cycle, the ECO cycle and Advanced cycle. The sterilization process consists of Initializing Stage, Sterilizing I Stage, Sterilizing II Stage, and the Finishing Stage. There is also a self-test program to check and clean the product every morning.

Program Non-lumen cycle ECO cycle Advanced cycle Self-Test

Subject Materials Surgical instruments without Lumen. Load is limited to under 5Kg Surgical instruments are limited to under 8Kg or two endoscopes. Instruments with narrow diameter and long distance, such as an endoscope. Load is limited to under 12Kg

Sterilization Time

Sterilizer inspection and cleaning

About 10 Min

About 28 Min About 45 Min About 62 Min

(2) Sterilization Process Sterilizing process is shown as follows: The door is locked automatically after the cycle start. And the door cannot open during the cycle run. (During the first 10 seconds, door is not closed)

- Initializing Stage Place the materials to be sterilized into the chamber and touch the start button to automatically start the sterilization process. This process makes the sterilizing chamber vacuous.

- Sterilizing I Stage This is the first actual sterilization process. Sterilant is sprinkled into the chamber and sterilization is conducted through the plasma and processes of diffusion and condensation.

- Sterilizing II Stage This is the second sterilization process. The first sterilization process is repeatedly performed in the inner chamber.

- Finishing Stage This process makes the pressure inside of the chamber into atmospheric pressure so that the sterilized materials can be taken out. Within this stage, sterilant remaining on the load is removed.

(3) Processing Chart RESM-004(Rev.12)

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RENOESM CO., LTD.

- Advanced Cycle

- ECO Cycle

-

Non-lumen Cycle

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5. RENO-S130 System Procedures 1) Explanations on Processing Cycles and Displays (1) How to Supply Hydrogen Peroxide ① Fully open the sterilizer door and place the items to be sterilized into the chamber. ② Insert the sterilant (RENO-SA10) as shown in the figure.

1. Eject the sterilant injection hole by pushing the button located at bottom right side of the chamber. 2. Hold of the RENO-SA10 (Red rubber) handle and put place the sterilant into the injection. 3. Check the blue lamp located at the top side. Push the sterilant injection back into position and close the door. 4. Check the red lamp located at the top side and press the start button. (Blue Lamp: RENO-SA10 in / Red Lamp: Door closed / Lamp off: no RENO-SA10, door is not closed )



Make sure to wear protective gloves when you put in and take out the sterilant.



The sterilant is a strongly irritant and could burn or irritate your skin and eyes.



If sterilant comes in contact with skin, wash it out rapidly.



Comply with hospital waste disposal policies when disposing of used RENO-SA10.



Close door at all times even when not operating. (Cause for sterilization hindrance)



Remove the sterilant when the display shows that sterilization is complete.



(2) Self–Test Mode RESM-004(Rev.12)

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RENOESM CO., LTD.

# The user can check the unit‟s condition for operating the Self-Test Mode 1cycle /day before the unit operation. (Total operation time about 10 Min.)

(3) User Mode i) Advanced Mode (or Non-lumen / ECO)

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Operation print paper ii) Explanations on Touch Screen ①Turn on the manual switch at the bottom side of the touch panel. The touch panel start screen will be displayed after 10 seconds.

-

User Mode: Enters selected operation program of Non-lumen cycle, Eco cycle, and Advanced cycle.

-

Self Test: Used for product inspections, moves to the start screen.

-

Maintenance: Moves to screen used for equipment checks by engineers.

-

Monitor: Moves to screen showing current progress state.

②When User Mode is pressed, the following screen is displayed. From Non-lumen Cycle, ECO Cycle or Advanced Cycle, select the sterilization program that you want to use.

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RENOESM CO., LTD.

To go back to the start screen, press the “HOME” button. The start screen is displayed. ③ When the “START” button is pressed on the START screen, the cycle process screen is displayed.

To return to the start screen, press the “Home” button.

④The cycle process screen displays the process progress. The current progress state cycle window changes from blue to red.

The progress time of each process and the remained operation time is displayed on the screen while providing notice of the pressure and temperature within the operating sterilizer. If the user wants to stop operation, you cannot turn off the power. Press the “CANCEL” button to stop operation instead. To return to the start screen, press the “HOME” button. At this time, the sterilizer will continue operating.

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RENOESM CO., LTD.

⑤When the process is complete, the completion screen is displayed and the buzzer sounds for 10 seconds. In addition, the printer will print related information.

⑥ Press the “HOME” button at the bottom right side to return to the start screen.

(4) Adjust the Date and time on the screen ① Turn Off the power and then the turn on the power. Press the Top side screen when you hear the beep sound. The screen shows “Main Menu” on the display.

② Press the Date and Time icon on the bottom screen, and then the Date and time setting screen will shows on the display

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RENOESM CO., LTD.

③ Press the date or time which you want to changes. And change to the real date and time with using number keypad. If you press the “ENTER” button, the changed date save and the time setting screen disappear when you complete the time adjustment. ④. Press the “X” button on the Top-Right corner on the screen. And then initial screen will show on the display. Check the changed date is correct or not on the bottom screen

(5) Explanation of Service Engineer Screen (Maintenance mode) ①Press the Maintenance button in the start screen.

The PASSWORD screen is displayed. ②When the PASSWORD screen becomes displayed, press the **** box, enter the password and press ENTER. (*note: Do not share the password with anyone except the service engineer „0501‟.)

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RENOESM CO., LTD.

③The Maintenance screen is displayed.

The total operation count, sterilizer pressure and temperature are displayed on the screen. The sterilizer parts subject to maintenance are classified in four categories of Vacuum Part, Injection Part, Pressurize Part, and ETC. When the blue device icons within each part is pressed, the icon changes to red and the corresponding part will begin to operate. When you press the red device icon again, it returns to the blue color and the part will discontinue operating. - Main Pump: a functional vacuum pump that creates a vacuum state in the chamber. - Vacuum Valve: a valve that opens/closes when making vacuum in the chamber. - Vent Valve: a valve that opens/closes when breaking vacuum in the chamber. - Plasma 2: a plasma generator that releases hydrogen peroxide released as oxygen and water vapor after sterilization. - Inj. Valve 1: value that supplies hydrogen peroxide during sterilization 1 process. - Inj. Valve 2: valve that supplies hydrogen peroxide during sterilization 2 process. - Compressor: pump that creates pressure during processing plasma. - Comp. Valve: valve that opens/closes during processing plasma - Plasma 1: a plasma generator that sterilizes the load in the chamber. - Door Solenoid: a locking device that the door during operation. - Buzzer: outputs sound when errors occur or when the operation is complete. Normal users may never operate Maintenance Mode. Only service engineers are allowed to operate Maintenance mode.

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Each component can be operated without actually operating the sterilizer to quickly inspect the condition of each component. Press the “HOME” button to return to the start screen. Press the “Monitor” button to return to the Monitor screen.

(6) Monitor Mode ①

Press the Monitor button in the start screen.

②

The process screen is displayed.

The currently operating process cycle will change to red to indicate it is operating. If the process is in wait state, the icon colors are all blue. The progress time of each process and the remainde operation time is displayed on the screen while providing notice of the pressure and temperature within the operating sterilizer. If the user wants to stop operation, you cannot turn off the power. Press the “CANCEL” button to stop operation instead. To return to the start screen, press the “HOME” button. At this time, the sterilizer will continue operating.

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2) Deal drawing of the device

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3) Understanding of Each Part’s Name and Measures (1) Vacuum Pump - Rotary Vane Pump

- Check Points ① Switch on the pump in the maintenance mode and measure air emissions by touching the exhaust section. If not loaded within one minute and there is excessive air emissions, replace the pump. (The pump has a leak.) ② Gas ballast valve always Open. Check the gas ballast (O=off,

I=Open).

③ Oil change: Each 600 cycles replace oil. Oil visual check- If it changes from transparent to darken, replace it. ④ Quantity of oil refill:

0.6~1.4 Liter

(Check if it is filled in the oil level when checking the quantity of oil) ※ Following next Oil change instruction. ⑤ Dirt Trap( #2 ) cleaning: Each 600 cycles Remove the Dirt Trap from the intake port in vacuum pump. And rinse in a suitable vessel with solvent. Then thoroughly dry it with compressed air. ⑥ EOCR Setup value: D- 5sec (Starting current) / Pump Load(A)-18A / O-3sec (Driving current) ⑦ Oil Mist Trap : It reduces the Oil(lubricant) consumption of pump to an insignificant level.  Each 600 cycles replace filter elements  If the Oil vapour or smell happened, replace filter elements ※ Following next Oil mist trap replace instruction. ⑧ Check the leakage and closing state on the oil fill plug when the regular periodic inspection or changing oil.

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⑨ If the environment temperature is below 15℃ and pump is not warming up, pump starting current is high and then happen Error 4 or circuit breaker down.

※ Oil change instruction

Oil-fill plug

Oil-level mark ”maximum” Oil-level mark ”minimum” Gas ballast Oil-drain plug Hazardous wastes may escape from the pump and oil. Take adequate safety precautions. For example, wear gloves, face protection or breathing protection. The oil must be changed or refilled when it looks dirty or if the oil level is not adequate. The oil should be replaced at least every 600 cycles. Change or refill the oil while the pump is still warm. (over 18℃, operate at least 10 minutes ahead of oil replacement.) Tool : Allen Key 8mm (Hexagonal wrench 8mm) for plug.

1. System power Off. 2. Remove the oil-drain plug and let the used oil drain into a suitable container. 3. When the flow of oil slows down, screw the oil-drain plug back in, briefly switch on the pump (max. 10 seconds) and then switch it off again. 4. Remove the oil-drain plug once more and drain out the remaining oil. 5. Screw the oil-drain plug back in (check the gasket and reinstall a new one if necessary). 6. Remove the two oil-fill plug and fill in with fresh oil (Not max, almost 4/5). 7. Screw the oil-fill plug back in. Check the tightening torque for the plugs. 8. Remove the lubricant from the Oil mist trap too.

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※ Oil mist trap replace instruction

< Oil mist filter elements> Perform this together when pump oil is replaced every 600 cycles. Tool : Allen Key 8, 6mm (Hexagonal wrench 8,6 mm), 10mm spanner or wrench. 1. Remove the oil-drain plug (1) and let the old oil drain off into a suitable container. 2. Screw oil-drain plug(1) back on (Check the gasket(22), change if necessary) 3. Loosen screw(15) and connection line(16) from the pump. 4. Disassemble clamp between pump and casing cover(7). 5. Loosen 4 screws(8) and remove filter casing(2) and pull off the cover of the filter casing(7). 6. Loosen 2 screws(3) and bridge(4) and remove the bridge(4). 7. Replace the used filter elements(5) with new one. Make sure that the vulcanised on seal of the filter elements is seated in the centering groove in the housing cover. 8. Tightly screw bridge and nuts back on, paying attention to the correct fit of the filter elements in the openings of the bridge(4) and casing cover(7) 9. Check the seal(6) and Screw filter cover(7) back on then tightening torque for screws(8) 10. Assemble clamp and the connection line(15) and screw(15)

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(2) Door Gasket - Check Points ①

Door and gasket should be kept vertically when attached.

②

There should be no hardening or grooves. (Replaceable item)

③

Gasket must be clean without any dust or foreign substances.

(3) Temperature Controller

- Setting value Common Points: Upper number display the real temperature, and down number display the setting temperature. (1) Change the Setting Temperature If you want to change the setting temperature, press the “SET” button. And you can change the setting value with the arrows in change mode. Change the setting value by arrows that change a 0.1℃ with one pressing. And then press the “SET” button and changed setting value is stored. (2) Change the High/Low Limited Temperature. If you want to adjust the Limitation High / Low Temperature, press the “SET” button for 3 seconds. You will the “ALH “display and blinking value. You can adjust the setting value with the arrows in change mode. And if press the “SET” button, the display change to the “ALL” (go

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to next stage). You can adjust the setting value with the arrows in change mode. And then press the “SET” button for 3 seconds and changed setting value is stored. Alarm Limitation High (ALH)

Alarm Limitation Low (ALL)

Chamber

60℃

40℃

Vaporize

250℃

150℃

If high temperature happened, the ALH lamp lights on. If Low temperature happened, the ALL lamp lights on (4) Plasma 1, Plasma 2 unit

- Check points ①

Check the vertical position of the electrode (Check the vertical position between

electrodes and attach within 5mm of electrode distance) ②

If not loaded, check if an arc is generated between electrodes (Press PLASMA 1 and

PLASMA 2 in Maintenance MODE.) ③

Countermeasures: Upon the occurrence of a problem, replace the entire module.

(5) Solenoid Valve - Check points ①

Measure the resistance value between solenoid valve‟s both ends by multi-meter device:

- Vacuum Valve: 60Ω ±10Ω

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- Vent Valve: 60Ω ±10Ω - Inj. Valve 1, Inj. Valve 2: 102Ω ±10Ω - Comp. Valve: 60Ω ±10Ω

②

If a „click‟ does not sound while pressing the Solenoid Valves in Maintenance Mode, such

indicates that the item must be replaced.

(a) Injection Valve (2ea)

(b) Vacuum Valve

(c) Vent & Comp Valve

(6) HEPA Filter - Check the every 1200 cycle or per year. And After 2400 cycle or per two years, replace the item.

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(7) Injection Heater - Check points ①

Use a multimeter to check the resistance value at both ends of the injection heater:

330Ω±15 Ω ②

Countermeasure: Replace if the resistance at both ends are open or if a real resistance

does not exist. (Replaceable item)

(8) Electric Panel

MAIN BOARD

TEMP CONTROLLER

5V SMPS 24V SMPS

SOLID STATE RELAY FUSE RELAY EOCR

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(a) PUMP SSR

RESM-004(Rev.12)

(b) chamber (Heater) / Injector (Heater) / plasma1 / plasma2 /com SSR

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4) PM cycle (Ref.> 5cycles/day, 25days/ Month, 1500 cycles/ years)

① Replace Parts Qan’ty [S130]

Replace cycle

Replace year

Injection Valve plunger

2

1200

1

H2O2

Injection Valve Body

2

2400

2

INJECTION

SFS nozzle

1

2400

2

High Temp. Center-Ring

1

2400

2

Plasma Unit

1

2400

2

VACUUM

Rotary Pump Oil

-

600

0.5

UNIT(1)

Activated carbon Filter –

1

600

0.5

Oil-Mist Trap- Inside filter

1

1200

1

HEPA Filter

1

1200

1

Qan’ty [S130]

Check cycle

Check year

Unit

CORONA

Description

PLASMA

Inside Filter

VACUUM UNIT(2)

② Check Parts Unit

Description

CHAMBER

Chamber Inside Cleaning

1

600

0.5

DOOR

Door Gasket

1

1200

1

Injection Valve plunger

2

600

0.5

H2O2

Injection Valve Body

2

600

0.5

INJECTION

SFS nozzle Holes

1

600

0.5

Injection Heater

1

1200

1

PLASMA

Plasma Unit

1

1200

1

UNIT(1)

Compressor

1

1200

1

(DBD)

High Voltage Transformer

1

1200

1

Com Solenoid

1

1200

1

PLASMA UNIT(2) (Corona) VACUUM UNIT(1)

Plasma Unit

1

1200

1

High Voltage Transformer

1

1200

1

Oil-Mist Trap

1

600

0.5

VACUUM

Vacuum Valve

1

1200

1

UNIT(2)

Vent Valve

1

1200

1

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6. Error Mode (1) Errors Mode Code

Message

Explanations

Actions to take

Occurs when it does not reach

1. Check the items that are limitations

00mTorr for setting minutes in the

of sterilization or have the moisture.

initializing 01

section

during

the

2. Reprocess it after removing

process. (Eco cycle within about 13

moisture from the items to be

min / Advanced cycle within about

sterilized or reducing the limitation

16 min)

items. 3. Call engineer upon occurrence of problem

Occurs when the pressure does not 1. If sterilant has hydrogen peroxide.

02

reach 20T for setting minutes within

(Re-perform the process after

in the DIFF section during the

inserting new hydrogen peroxide.)

process. (ECO cycle about 5min / 2. Call engineer upon occurrence of Advanced cycle about 8min)

problem.

Occurs when user notices problem If you press button during the and presses “CANCEL” button. 03

process, it will be carried out as finish „processing. Must be re-sterilization.

Occurs due to abnormality or over04

currents of pump in any section during

Call engineer upon occurrence of problem.

the process

05

06

RESM-004(Rev.12)

Occurs when the chamber

Call engineer upon occurrence of

/vaporizer temperature reaches

problem.

more than 60/ 250 degree.

Occurs when the chamber

Call engineer upon occurrence of

/vaporizer temperature does not

problem.

reach more than 40 /150 degree.

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RENOESM CO., LTD.

08

Occurs when secondary output of

Call engineer upon occurrence of

high-voltage

problem.

transformer

is

not

sensed. Occurs when secondary output of high-pressure transformer is not 09

problem

sensed (Plasma 2)

Occurs when it does not reach 600mTorr for 30 minutes in the sterilizing I section during the 10

1. Check the items that have sterilization limitations or have moisture. 2. Reprocess after removing moisture from the items to be sterilized or reducing the limitation items. 3. Call engineer upon occurrence of problem.

process

11

Call engineer upon occurrence of

Occurs when processing is not

Call engineer upon occurrence of

carried out smoothly during the self-

problem.

test process.

Occurs when the cycle has started ALARM

without sterilant cassette. 2. Start cycle.

1

ALARM

1. Insert RENO-SA cassette.

Occurs when Self-test is started

2. Remove RENO-SA cassette.

with sterilant cassette.

3. Start Self-test

Occurs when the cycle starts with

1. Close chamber door shut.

chamber door open.

2. Start cycle.

Occurs when the system error

1. Turn off the power and then

2

ALARM 3

turn on the power

ALARM 4

RESM-004(Rev.12)

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RENOESM CO., LTD.

(2) Measuring (Trouble Shooting) Code

Message

Countermeasure

①

Check the state of sterilizing materials(Y) → Take them out and

conduct SELF-TEST Mode (Y) → If there is an abnormality with the sterilization, correct them and re-operate. 01

②

Conduct SELF-TEST Mode (N) → Open the pump and vacuum

valve in the Maintenance Mode and check the maximum vacuity (500mTorr/3min)(N) → Check the valve Door, Piping leak, ①

Take the sterilizing materials out and conduct SELF-TEST (N) →

Check the solenoid valve of sterilant-supplying part. ②

Open the door and check if there is sterilant in the syringe (Check

if the orange rubber exists at the lower part of the syringe)(Y) → 02

Check if the sterilant needle and its hole are matching (Y)→ Check the injector heater temperature ③

Check the pressure gauge (Check the indication of 20,460mTorr

on stand-by) User option 03

①Check the pump oil level. If abnormal, replace or fill. ②Check the environment temperature is below 15℃. If below 15℃ and not warming up, the pump starting current is enough 18A for Error 4. Change the environment temp. heating more 15℃ or EOCR A Load more than 20A. ③ Turn the power off/on if it is on with“01” error when first turned on 04

and checks the error. ④ If errors continue, adjust EOCR-SS‟ O-Time in electric unit and DTime or A Load. [EOCR Countermeasure] a. A Load: The set value for total load consumed upon device operation.

RESM-004(Rev.12)

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RENOESM CO., LTD.

Set value: (Total power consumption: 20A/ Setting: 18A (Initial consideration of initial current)) b. D-Time: As a supplement measure for the starting current that occurs upon initial operation, a set value for which the EOCR does not operate (detect). (Delay Time) >>> Sett value: If an error occurs within 5 seconds, reset within 10 seconds. c. O-Time: As a supplement measure for the overload that occurs upon operating the device, a set value for which the EOCR does not operate (detect). >>>Set value: Reset within 3 seconds ① Check the Chamber heater resistance number. (147Ω/ 10%) Check the Injection heater resistance number. (330Ω/ 10%) ② Check the temperature adjuster./ Check PT 100 Ω sensor  05

Replace when required Follow the setting temperature if main office proceeds with OQ. (Chamber 45℃/ Injection 10%, 185℃/10%) ③Check the PSSR(1)/(2) ① Check the Chamber heater resistance number. (147Ω/ 10%) Check the Injection heater resistance number. (330Ω/ 10%) ② Check the temperature adjuster./ Check PT 100 Ω sensor  Replace when required

06

Follow the set temperature if main office proceeds with OQ. (Chamber 45℃/ Injection 10%, 185℃/10%) ③Check the PSSR(1)/(2) ④Check the connection wires. ①

Check the state by turning PLASMA 1 on in Maintenance

Mode. ②

Re-adjust the distance of electrodes in the inner plasma

08

chamber to 3mm vertically.

RESM-004(Rev.12)

③

Check the state of PSSR (3)

④

Check current sensor.

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RENOESM CO., LTD.

① Check the state by turning PLASMA 2 on in Maintenance Mode. ② Readjust the distance of electrodes in the inner plasma chamber to 09

3mm vertically. ③ Check the state of PSSR (4). ④

Check current sensor.

①

Check the state of sterilizing materials(Y) → Take them out and conduct

SELF-TEST(Y) → Remove moisture from them and reduce them. 10

②

Conduct SELF-TEST(N) → Open the pump and vacuum valve in the

manual condition and check the max vacuity(500mTorr/3min)(N) → Check the valve, Door, Piping leak,

11

①

Poor pressure status: Perform vacuous testing in MAINT MODE

②

Check pressure gauge(Check indication of 20460mTorr on standby)

③

All valves Check state of (Replace when required)

④

Open the pump and vacuum valve in the manual condition and check the

max vacuity (500mTorr/3min) (N) -> Replace when required. ⑤

Check the SSR state.

① Insert RENO-SA cassette. ALARM

② Start cycle.

1

① Remove RENO-SA cassette. ALARM

② Start Self-test

2

① Close chamber door shut. ALARM

② Start cycle.

3

ALARM

①

Turn off and then turn on the power

②

Start cycle.

4

RESM-004(Rev.12)

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RENOESM CO., LTD.

Chapter 3: Installation of Products 7. RENO-S130 System installation 1) Introduction This section describes the installation environment and the method of removing the RENOSeries Plasma Sterilizer box. Additionally, this section addresses the settings and the check points upon initial installation in addition to installation matters.

2) Unpacking (1) Boxing Dismantlement and Cargo-working ①Dismantle the package in a sufficiently spacious area. Despite the distance between place for dismantling and for installing, RENO-Series Plasma Gas Sterilizer has wheels at the bottom which makes it easy to move. ②Check the tilt watch and shock watch indicator color before dismantling. Location: 1 set at each left/right side respectively (Tilt & Shock Watch/1 Set)

Corrugated paper Shock watch

Front

Left

PET Band

Tilt Watch Pallet

[Picture 7-1] The Exterior Packing of the Product

If the color indicates red, stop working and inquire with the main office.

RESM-004(Rev.12)

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RENOESM CO., LTD.

(2) Dismantling the Triple Corrugated Cardboard ⓐ Use a forklift to put the equipment down safely in a place (minimum of 5m X 5m) where it can be dismantled. ⓑ Use a cutter to cut the PET band.

Corrugated paper Front Fixed Wood Left

PET Band

Corrugated

Cutting

paper

Protective vinyl

Air bag

[Picture 7-2] Dismantlement of Pet Band ⓒSeparate the triple corrugated cardboard from the equipment.

Fixed wood (2EA)

[Picture 7-3] Separation of Triple Corrugated Cardboard Box ⓓRemove the inner protective vinyl. ※Be careful not to damage the equipment.

RESM-004(Rev.12)

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RENOESM CO., LTD.

Fixed wood

[Picture 7-4] Removal of vacuous Vinyl and Protective Vinyl

ⓔSeparate the fixed snap lock of fixed neck. ⓕ Use a forklift and lift the equipment (the side) up to over 250 mm as shown in the picture below.

Forklift’s Fork

(a)

(b)

[Picture 7-5] Location of Forklift‟s Fork Be careful not to impact the foot master (=movable wheels) when inserting the fork to the bottom of equipment. Load the equipment with the fork more than 250mm away to the front (the opposite side). (Refer to Picture (b).)

ⓖPut down the equipment in a flat place where it can move. ※Have the palette in a proper place and do it away since it should not be re-used.

RESM-004(Rev.12)

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RENOESM CO., LTD.

ⓗMoving equipment: Use hand palette to move from the place for loading and to another for installing. If moved by man, it should be done by a group of two people. Be careful not to impact the touch panel and printer when moving the equipment.

Lock (ON)

Unlock (OFF)

There are 4 wheels for carrying located under the product. Before moving, you have to check the break lever whether lock or unlock. If you want fix the wheels, push the break lever to Lock (ON).

- Move with force on the backside

- Don‟t the labored force on the front

when machine moving.

when machine moving.

(Be careful of front obstacle.)

(Be careful of front obstacle.)

[Picture7-6] Caution of Its Move ⓛDo not operate the equipment within 4 hours after it is moved and installed. (Install it with the fixed pad touching the ground to prevent movement between operations.

3) Installing Environment ⓐInstall and use indoors. ⓑAcceptable error of input power change: within ±10% (It must be grounding of first sort.) ⓒTemperature: 15 ~ 40℃ (If temp. below 15℃, pump starting current is high and happen Error 4) ⓓHumidity: 5℃~30℃/ 80%, 31℃~40℃/ 50%

RESM-004(Rev.12)

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RENOESM CO., LTD.

ⓔ Install it at a safe place away from slope, vibration and impact, etc.

4) Checking after Installation 1) Fix the power plug after installation. (2) Lift up the main breaker at the bottom of the back of equipment and turn on the passive switch. # Note: Conduct “(3)” within four hours after installation (3) Choose the self-test button in the preliminary screen and press the START button.

(4) The process will be finished in about eight minutes and is completed when the buzzer rings. (5) Do not sterilize within four hours after installation is finished. (6) If it is not normally completed and error occurs, run self-test again after taking appropriate measures.

5) Caution for installation (1) Do not install the equipment if you are not a skilled or trained worker. (2) Install the equipment at least 30cm away from the wall and in a place with flat floor (within 3°) (3) Do not impact the equipment in the moving. (4) Do not use it in a place where equipment that releases much electromagnetic wave is close by. (5) Do not let the power cord be unplugged while using the equipment. And the wall socket must use for only one sterilizer. (6) Check the status of equipment after finishing using it. (7) Do not separate, repair, or reorganize the equipment if you are not a supervisor or person authorized by Renosem Co., LTD. (8 ) Cleanse the external equipment or inner chamber with clean and dry cloth with alcohol and material and do not use other cleaning fluid.

RESM-004(Rev.12)

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RENOESM CO., LTD.

(9) Do not install it in a place where heat of fire or steam is generated.

Chapter 4: Diagram for the system 8. System Diagram 1) Introduction It describes the device of RENO-S130 Plasma Sterilizer, electric block diagram and details about connection diagram of each cable 2) Mechanic System (1)

CHAMBER ASM Service Parts

⑪ ①

RESM-004(Rev.12)

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RENOESM CO., LTD.

No

Part No.

Part Name

Spec.

QT‟Y

1

R301-0011

CHAMBER_COMP

-

1

2

SROM15_690

SLIDE_RAIL

SROM15_690

1

3

R301-0110

SHOULDER_BLOCK

-

MC.N

4

R301-0210

H2O2_INJECTION_MODULE_ASM

-

1

5

AWY20-90

TENSION SPRING

AWY20-90

1

6

R301-0310

SFS_NOZZLE_COMP

-

1

7

R301-0130

SOLENOID_LOCK_COMP

-

1

8

VX2350M-03-5G1

SOLENOID_VALVE

VX2350M-03-5G1

1

9

NW25_TEE

NW25_TEE

NW25

1

10

SETRA 730

VACUUM_TRANSDUCER

SETRA 730

1

11

CLAMP_WINGNUT___NW25

CLAMP_WINGNUT

NW25

10

12

CENTERING_RING___NW25

CENTERING_RING

NW25

10

RESM-004(Rev.12)

- 45 -

Ref

RENOESM CO., LTD.

(2)

FRAME ASM Service Parts

①

No

Part No.

Part Name

Spec.

QT‟Y

1

R302-0020

FRAME_COMP

-

1

2

R302-0190

PANEL_COMP_ELEC

-

1

3

R302-0220

BRKT_CHAMER_FLANGE_GUIDE

-

1

4

R302-0230

PUMP_COMP

-

1

5

KA-50

RUBBER_DAMPER

KA-50

4

6

22-3KAF

TRANS

22-3KAF

1

7

TF-168

MINI_COMPRESSOR

TF-168

1

RESM-004(Rev.12)

- 46 -

Ref.

RENOESM CO., LTD.

(3)

DOOR ASM Service Parts

No.

Part No.

Part Name

Spec.

QT‟Y

1

R303-0220

DOOR_HANDLE

ABS

1

2

R303-0210

DOOR_COVER_DECO_PLATE

ABS

1

3

R303-0200

DOOR_PLATE_MTG_COVER

SPCC

1

4

R303-0100

DOOR_DECO_AL_EXT_PLATE

ABS

1

5

R303-0020

DOOR_PLATE_MAIN

AL6061

1

6

R303-0080

DOOR_SEALING_RUBBER_GASKET

SILLICON

1

7

R303-0060

DOOR_FLOATING_JOINT_BLOCK

STS304

1

8

R303-0070

BRKT_FLOATING_JOINT

SPCC

2

9

AN215

O-RING

AN215

2

RESM-004(Rev.12)

- 47 -

Ref.

RENOESM CO., LTD.

(4)

UPR COVER ASM Service Parts

No

Part No.

Part Name

Spec.

QT‟Y

1

R304-0020

MAIN_EXT_BAR_UPPER_COVER

-

1

2

R303-0040

SIDE_EXT_AL_BAR_RIGHT

-

1

3

R304-0080

PCB_ASM_FOR_SIDE_SLOT

-

1

4

XTOP08TV

TOUCH_PANEL

XTOP08TV

1

5

R304-0050

TR_ACRYLE_PLATE

-

1

RESM-004(Rev.12)

- 48 -

Ref.

RENOESM CO., LTD.

(5)

LOWER COVER ASM Service Parts

No.

Part No.

Part Name

Spec.

QT‟Y

1

R308-0020

LOWER_COVER_COMP

-

1

2

R308-0110

SIDE_EXT_AL_BAR___RIGHT

-

1

3

R308-0120

MTG_BRKT_LOWER_COVER_R

-

1

4

R308-0130

MTG_BRKT_LOWER_COVER_L

-

1

RESM-004(Rev.12)

- 49 -

Ref.

RENOESM CO., LTD.

(6)

SIDE DECO ASM Service Parts

No.

Part No.

Part Name

Spec.

QT‟Y

1

R309-0020

SIDE_DECO_AL_EXT

-

1

2

R309-0030

LED_GUIDE

-

1

3

5PI___LED

LED

-

1

4

R309-0040

Interactive Board

-

1

RESM-004(Rev.12)

- 50 -

Ref.

RENOESM CO., LTD.

(7)

S130 ASM Service Parts

No

Part No.

Part Name

Spec.

QT‟Y

1

R302-0010

FRAME_ASM

-

1

2

R303-0010

DOOR_ASM

-

1

3

R308-0010

LOWER_COVER_ASM

-

1

4

R304-0010

UPPER_COVER_ASM

-

1

5

R306-0010

LEFT_SIDE_COVER

-

1

6

R307-0010

RIGHT_COVER_FRAME

-

1

7

R309-0010

SIDE_DECO_AL_EXT_ASM

-

1

8

R305-0010

RR_COVER_ASM

-

1

RESM-004(Rev.12)

- 51 -

Ref.

RENOESM CO., LTD.

(8)

O3 REACTOR COMP. Service Parts

No

Part No.

Part Name

Spec.

QT‟Y

1

R380-0100

O3_REACTOR_BRKT

-

1

2

R380-0120

O3_REACTOR_ASM

-

1

3

R380-0110

O3_REACTOR_COVER

-

1

4

CUA-4

FITTING

-

4

5

SOCKET_HEX_BOLT_M5x12L

SOCKET_HEX_BOLT

M5x12L

4

RESM-004(Rev.12)

- 52 -

Ref.

RENOESM CO., LTD.

(9)

PLASMA HOUSING ASM Service Parts

No

Part No.

Part Name

Spec.

QT‟Y

1

R301-0470

FLANGE_CAB

-

2

2

O-RING___215

O-RING___215

AN215

6

3

R301-0460

MID_CAB

-

2

4

R301-0450

ELECTROD_COIL

-

1

5

R301-0430

HOUSING_PLASMA

-

1

Ref.

6

RESM-004(Rev.12)

- 53 -

RENOESM CO., LTD.

3) Electric System NO

Name of product

Q’ty

Specification

1

Electric Field Panel

653 * 548 * 1.6t

1

2

Electronic Excessive Current Relay

90-260V ∼ AC 3-20A/250V

1

3

Temperature Controller

220V /SSR contact point / -100 ∼ 400°C pt100

2

4

5V Power Supply

220V

1

5

24V Power Supply

220V 1.1A / 24V 5A

1

6

SSR

Input: 4~32VDC

1

7

PCB SSR

DC4-32V/ AC 240V/ 5A

1

8

Noise Filter

250V

1

9

FUSE/Holder

12A

10

Relay

DC 24V

11

M4 Round-headed Blot

M4 * 10mm

DC5V 8A

15A 50-60Hz 250V~

note

2

3.5A

2 1 235.4

150.24

171.56

ED6(Injection1)

32.06

ED6(injection2)

81.24

30.7

10.33

ED6(Chamber)

100

32.87

3.01

18.26

242.58

100

124.65

161.8

195.95

41.98

72.87

105.59

22.69

18.26

351.27

39.95

137.45

22.84

55.1

80.94

45.06

51.83

126.47

41.98

190.64

603.12

RESM-004(Rev.12)

- 54 -

RENOESM CO., LTD.

RESM-004(Rev.12)

- 55 -

RENOESM CO., LTD.

RESM-004(Rev.12)

- 56 -

RENOESM CO., LTD.

RESM-004(Rev.12)

- 57 -

RENOESM CO., LTD.

9. Statement of Conformity

0120 RENOSEM Co., Ltd. with its registered office and its headquarters at at Unit 103-806, 397, Seokcheon-ro, Ojeong-gu, Bucheon-si, Gyeonggi-do, Korea is the manufacturer of the Low temperature Plasma Gas Sterilizer. RENOSEM Co., Ltd. declares that this product conforms to the safety provisions as set out in Annex II (excluding Section 4), Classification class IIb, following the directive 93/42/EEC dated 8 November 2012 as certification Notified Body Number 0120.

RESM-004(Rev.12)

- 58 -

RENOESM CO., LTD.

10. Labelling - Explanation of Symbols on Pump and Consumables: SYMBOL

Explanation

Do not reuse

Batch code

Date of manufacture

Manufacturer

Authorized representative in Europe

Serial number

Use by

Caution, consult accompanying documents

0120

RESM-004(Rev.12)

CE Mark

- 59 -

RENOESM CO., LTD.

MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St.Ingbert, Germany

RENOSEM Co., Ltd Unit 103-806, 397, Seokcheon-ro, Ojeong gu, Bucheon-si, Gyeonggi-do, Korea

0120 Product Name

Low Temperature Plasma Gas Sterilizer

How to Use

User`s Manual Reference Model ( REF )

RENO-S130

Rated Input Power

3.0 KW

200V, 50/60Hz 230V~, 50Hz

Rated Input

RENOSEM Co., Ltd Unit 103-806, 397, Seokcheon-ro, Ojeonggu, Bucheon-si, Gyeonggi-do, Korea [www.renosem.com]

RESM-004(Rev.12)

MT Promedt Consulting GmbH Altenhofstrasse 80 66386 St.Ingbert, Germany

- 60 -

RENOESM CO., LTD.