(BM-055L) Service Manual (ENG - V1.0)

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Service Manual

BM-055L
Table of Contents

Table of Contents
Ⅰ. Installation of product
1. Installation Environment ------------------ 5 3) Explanation about Error
2. Installation of product ---------------------- 6 (1) Door Error ------------------------------ 23
- Enter into expert mode ----------------------- 9 (2) Cancel Error --------------------------- 23
3. Check of installation (3) Injection Heater Error ---------------- 24
1) Check output signals of heater ---------- 10 (4) Chamber Heater Error -------------- 24
2) Confirm operational status of each part (5) Charge H2O2 -------------------------- 25
--------------------------------------------------- 10 (6) H2O2 Supply Error ------------------ 25
3) Check of oil level ---------------------------- 11 (7) Wet Over Error ------------------------ 26
4) Charge of sterilant -------------------------- 14 4) Verification of sterilizing power
5) Self Test --------------------------------------- 15 (1) Chemical method -------------------- 27
4. Education for installation (2) Biological method ------------------- 28
1) Preparation for use ------------------------- 17 5) Cautions ------------------------------------- 29
2) How to use ------------------------------------ 18

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Table of Contents
2. Corrective measure for ERROR
Ⅱ. SERVICE 1) Door Error -------------------------------- 59
1. Replacing Consumables
2) Cancel Error ----------------------------- 62
1) Supplies replacement cycle ------------- 36
3) Injection Heater Error ----------------- 64
2) History management of consumables
4) Chamber Heater Error ----------------- 75
replacement ---------------------------------- 37
5) Charge H2O2 ---------------------------- 83
3) How to replace consumables
6) H2O2 Supply Error --------------------- 86
① Chamber door silicone ring ------------ 38
7) Wet Over Error -------------------------- 89
② Injection valve ----------------------------- 40
3. Drawing
③ Injection heater --------------------------- 43
1) Embedded -------------------------------100
④ Vacuum Gauges ------------------------- 44
2) DC Line ---------------------------------- 101
⑤ Vacuum valve ----------------------------- 46
3) AC Line ---------------------------------- 102
⑥ Vacuum pump oil ------------------------- 48
4. DATA Management
⑦ Oil Mist Filter ------------------------------ 52
1) Program Upgrade --------------------- 104
⑧ Plasma chamber -------------------------- 54
2) Log Data Back-Up -------------------- 106
⑨ Vent filter ------------------------------------ 56
5. How lumen --------------------------------- 108

Ⅲ. Manufacturer Contact
- Address and Contact ------------------- 110

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Installation of product
Installation of product

Installation Environment
1. Install in indoor location.
2. Install on flat floor.
3. There should be no fixed objects within 1 meter from the product.
4. Power
1) Use ground connected power.
2) Use power within ±10% of rated power.
5. Temperature & humidity environment
1) 5℃~30℃: 80% ↓
2) 31℃~40℃: 50% ↓

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Installation of product

Installation of product
1. Remove side & back cover

Turn to the revolving direction


by using flat-head screwdriver Remove back cover Remove left cover Remove right cover
or coin and pull the handle

2. Check whether screw is loose or not through tightening the clamp of each part by hand.

Injection chamber Vent valve

Vacuum valve
Vacuum gauge

Temperature sensor

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Installation of product
3. Insert the power cord into socket on wall.
-Confirm whether ground connected or not

4. Turn on main power switch (confirm if it is the power of temperature controller)

Main power switch Put up switch


Temperature controller

5. Turn on DC power (confirm the start-up screen indication after booting)

DC power switch

Start-up screen

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Installation of product
6. Enter into expert mode
- Refer to p.09

7. Release the vacuum state of the inside of chamber.


1) Turn on vent valve
-confirm it door open Turn on & off vent valve
2) Turn off vent valve

8. Confirm the communication state of screen


1) Confirm temperature indication of chamber
2) Confirm temperature indication of injection Confirm the communication

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Installation of product

Enter into expert mode


1. Method
1) Touch the part of sterilizer (a) by hand
2) Enter the number on password input window
-Password is 9981 (It can be changed by head office’s policy)

2. Caution
1) Only the people who can install the product & do technical service are allowed to enter into export mode and
users are not allowed to enter into expert mode except special cases.
turning on injection valve is prohibited in the vacuum state of the inside of chamber (H202 flows
into inside of chamber excessively).

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Installation of product

Check of installation
1. Check output signals of heater
1) Confirm if a, b, c, d of heater output signals on the picture occurs.
① a, d (Injection heater)
② b, c (Chamber heater)
d

a
c
2. Confirm operational status of each part
b
1) Enter into expert mode
2) Confirm ON operational status of each part and then, OFF
① Vacuum pump ON->Confirm operating sound of vacuum pump->vacuum pump OFF
② Vacuum valve ON->Confirm operating sound of vacuum valve->vacuum valve OFF
③ Vent valve ON->Confirm operating sound of vent valve->vent valve OFF
④ Door open->Injection valve ON->Confirm operating sound of injection valve->
Injection valve OFF->Door close ① ②
⑤ Plasma ON->Visual confirmation of plasma occurrence->Plasma OFF ④ ③
⑥ FAN ON->Confirm FAN ventilation->FAN OFF ⑤ ⑥

Operating injection valve is prohibited in the vacuum state of the inside of chamber.

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Installation of product
3. Check of oil level
- Over than 2/3 of level window (It drop short, make good a deficiency)

Upper limit of oil

Lower limit of oil

4. Warm up the product


- More than 2 hours after main power on

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1. Oil and filter change required
▷Cause: Replacement cycle of pump oil and filter
▷Remedy: Contact your provider to replace the oil and filter.
※ First time installation can not see alarm

2. Way off
- Touch to the sterilizer text(a) of main screen
- Touch to the Supp Manager text(b) of Expert Mode
b - Touch to the Pump Oil, Vacc Fiter, CabonFiter Text
- Touch to the Exchange
a - Twice touch to the Back

※ If the first time installing to


c the hospital
NO. 2(Way off) to proceed.

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Check of installation

Vacuum pump activation (First-time installation in the hospital)


1. Touch to the sterilizer text(a) of main screen
2. Touch to the password of Expert Mode
(Password : 9981)
3. Touch to the Vacc pume Text (Vacuum pump operation)
- Activates one hour.
4. Touch to the Vacc pume Text (Vacuum pump stop)
5. Twice touch to the Back

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Check of installation
5. Charge of sterilant
1) Take the sterilant out from packing box
2) Insert sterilant upside down into feeding entrance of sterilizer
3) Make 2~3 revolutions to clockwise and then stop at the position where silver foil tape shown in front.
4) Confirm if sterilant fixed by shaking slightly
5) Take silver foil tape of upper part (a) out to the one end or remove completely.

If it leaks or stains on body, wash it immediately with a plenty of water.

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Check of installation

6. Self Test
1) Touch self-diagnosis
2) Confirm message of self-diagnosis completion
3) Confirm output of printing paper.

Printouts

Self Test touch Self Test proceeding Self Test completion

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Education for installation
Education for installation- Preparation for use

Preparation for use

1. Preparation for use


1) The product should be always in the status of warm up and so, main power should be ON accordingly.
2) If main power is OFF or no electric supply to the socket, use the product after warming up for 2~3 hours.
3) DC power OFF is no problem, however, always maintain ON for extension of product life & protection.
-. Operate vacuum pump for 1 minute in every 30 minutes.
-. Buzz sound occurrence for protection of door open
4) If the product is not in use for long time, use it after self test.
5) Should always close the doors of the product state.

If door is opening for long time, it is twisted by overheating.

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Education for installation – How to use

How to use
1. Remove the moisture of object for sterilizing after washing completely. 1*
2. Pack the object for sterilizing. 2*
3. Open the door and put the packed object for sterilizing evenly in the inside of chamber 3*
4. Close the door and touch standard sterilization or surface sterilization on LCD Indication window by hand

Touch for choice

Sterilizing process
Start-up screen Completion screen Start-up screen
proceeding

1*. Product life of pump in equipment is to be shorten if moisture is not removed completely.
2*. Use exclusive pouch & sterilized cotton for plasma sterilizer, set the temperature of pouch sealing
appliance at 125℃
3*. Pay attention that the amount of object for sterilizing does not exceed about 70% space of the inside of
chamber.

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Education for installation – How to use
5. After completion of sterilization, the words of ‘sterilization completed’ appeared on screen along with buzz
sound and it printed out. (On printed material, cumulative number, time of sterilization completion & finish-time,
lead time per the process and success or failure of sterilization are indicated).
6. If you push the confirmation button in below part after confirming sterilization completed, it returns to the start-
up screen.

※ What is difference between standard sterilization & Advanced & surface sterilization sterilization?

▷ Standard sterilization : It’s a process for sterilizing up to the inside of object for sterilizing
(Need about 36 minutes)

▷ Warm Up sterilization : It’s a process for sterilizing Much of cold metal of object for sterilizing
(Need about 54 minutes)

▷ Advanced sterilization : Advanced than the standard sterilization process Sterile improved
process (Need about 50 minutes)
(Complex surgical instruments for sterilization)

▷ Surface sterilization: It’s a process for sterilizing the surface of object for sterilizing
(Need about 24 minutes)
(It is used for simple appliances and urgent sterilization owing to its short time of sterilization).

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Sterilization process and device

Class 1 Class 2 Class 3

Warm-up Sterilization Advanced Sterilization Standard Sterilization

Hammer part Scope part Scissors part Guide part

Osteotome / Chisel part Endoscope part Forceps part Elevator part

Gouge part Scope Line part Dressing Forceps part Lever part

Impactor part Shaver Line part Holder part File part

Plier part Light Cable part Suction Tube part Currette part

Spanner part Bovie / Bipolar part Tip part Speculum part

DRILL part Burr part(Line, Tip) Clamp part Hook / Loops part

Saw part Retractor part Punche part

Tubing part Cutter part Rongeur part

Probe part RF gun part

Curettes part Spinal needle part

Handle part

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Education for installation – How to use
7. Cancel the sterilization
1) How to cancel: Stop the process by push ‘Cancel’ button of below
- Message of ‘Cancel error’ indicated
- Proceed drying process to remove residual sterilant in the inside and then, complete.
- Print out the material about Cancel Error.

Touch for cancel

Process proceeds Cancelling process Completion screen


proceeding

If you do not push cancel button and power off, you may have burn skin due to residual sterilant.
After cancellation, you should complete through the finishing process of sterilization without fail.

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Education for installation – How to use
2) Cases of cancelling sterilization process
- When no-acceptable object for sterilizing inserted.
- When the packing of object for sterilizing is wrong.
- When the moisture of object for sterilizing is not removed and inserted.
- When the sterilization without the object for sterilizing is proceeding by user’s carelessness.
- When any doubt if the object for sterilizing inserted in more than 70% of the inside space of chamber.
- When you suspect a product of more than

Pay attention that do not touch during sterilization process except above reasons.

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Education for installation – Error

Explanation about Error

1. Door Error
▷ Cause: If implement the sterilization in the state of door open

▷ Action: Close the door and implement the sterilization again.

2. Cancel Error
▷ Cause: If push ‘Cancel’ button by user’s mistake.

▷ Action: After settlement of user’s cancel purpose, implement


the sterilization again.

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Education for installation – Error

3. Injection Heater Error


▷ Cause: If any disorder of injection heater occurred.

▷ Action: If it’s within 2 hours from main power supply of product, wait until warming
up and contact the supplier if it is occurred during the use in the state of main power
supplied.

4. Chamber Heater Error


▷ Cause: If any disorder of chamber heater occurred.

▷ Action: If it’s within 2 hours from main power supply of product, wait until warming
up and contact the supplier if it is occurred during the use in the state of main
power supplied.

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Education for installation – Error

5. Change H2O2
▷ Cause: If any shortage of sterilant in the inside of product

▷ Action: Supplement sterilant and implement sterilization.


(Contact the supplier if you don’t have sterilant)

6. H2O2 Supply Error


▷ Cause: If any problem of sterilant supply during the implementation of
sterilizing process.

▷ Action: If it repeated after implementing sterilization again, contact the


supplier.

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Education for installation – Error

7. Wet Over Error


▷ Cause:
- If a lot of moisture existed in the inserted object for
sterilizing.
- If the materials which can absorb moisture inserted
(paper, fabric, wood, sponge, powder etc.)
- If any disorder of product occurred.

▷ Action:
- Empty the inside of chamber and implement self-
diagnosis. If it is completed within normal time (5
minutes), confirm the moisture of inserted object
for sterilizing, dry, remove the materials which can
absorb moisture and then, sterilize again.
- If wet over Error in self-diagnosis occurred,
contact the supplier.

Self Test

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Verification of sterilizing power (Chemical method)

⑴ Chemical method
Chemical Indicator (CI) :
- It’s equipment for confirming the success or failure of sterilization after sterilization and it’s confirmed by
chemical method.
Judge whether the success or failure of sterilization by confirming if the color of CI changed or not.
The color is changed as hydrogen peroxide applied on CI with certain amount and judge the changed CI
means the success of sterilization

Before sterilization

After sterilization
(Success of sterilization)

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Verification of sterilizing power (Biological method)
⑵ Biological method
Biological indicator (BI)
- It’s equipment for confirming the success or failure of sterilization after sterilization and it’s confirmed
by biological method.
Judge whether the success or failure of sterilization by confirming if the culture solution color in the inside
of BI changed or not.
If hydrogen peroxide penetrates into the inside of BI and kills all of Geobacillus Stearothermophillus virus
which is cultured in culture medium, it maintains the initial color of purple, on the other hand, if virus is not
killed and cultured, the color of culture solution changed to yellow color.

※ Cultivation should be done at 60℃, for more than 48 hours.

Specifications of Biological indicator (BI)


1. Manufacturer: SGM
2. Product name: EX Test
After sterilization After sterilization
3. Name of virus: Geobacillus Stearothermophillus
(Success of sterilization) (Failure of sterilization)
4. Number of virus: 2.9x10^6 spores/unit
5. Size of carrier: 7.16mm diameter

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Education for installation- Cautions

Cautions

① Never include the things which can absorb sterilant such as sponge, paper, wood, fabric etc. in the objects
for sterilizing.
- It absorbs sterilant and the sterilant may insert into the inside of chamber excessively
- The absorbed sterilant remained even after completion of sterilizing process and may cause smell &
reaction on hand.
② The object for sterilizing should be washed & dried completely without fail before sterilization and then,
implement the sterilization.
- If moisture remained, wet over error may occur.
- If moisture injected into vacuum pump excessively, the lives of pump oil & filter is to be shorten.
③ Fill the object for sterilizing in the inside of chamber with the amount of below 70% space and then,
implement the sterilization.
- If Fill the object for sterilizing too much for sterilization, sterilizing power may decline or sterilant may insert
excessively.
- It’s better to have good space for inserting hand in the chamber after the object for sterilizing inserted into
chamber.

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Education for installation- Cautions

Cautions

④ Use sterilized pouch & non-woven fabric only for low-temperature plasma sterilizer.
- Pouch
▷ Different sealing temperature of sealing appliance (EO-GAS: 170℃, low-temperature plasma: 125℃)
▷ If use EO-GAS & steam sterilizer pouch, particle size is different and effect the penetration of sterilant.
As a result, the sterilizing power may decline or is not working
- Sterilized fabric
▷ For low-temperature plasma, it is commonly accepted material of polypropylene.
▷ Never use the sterilized fabric which coated on one side.

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Education for installation- Cautions

⑤ Use BI & CI indicator only for low-temperature plasma sterilizer without fail.
- If it’s not only for low-temperature plasma, accurate sterilizing power cannot be guaranteed.
⑥ BI should be cultured for 48 hours without fail after sterilization
- Confirm the result of cultivation
▷ Success of sterilization: Maintain the existing purple color
▷ Failure of sterilization: Confirm the virus cultured to yellow color

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Education for installation- Cautions
⑦ Use-by date of the object for sterilizing packed by using sterilized pouch is 6 months.
- User decides the packing in accordance with the usage of sterilized goods & duty cycle and if packing is
insufficient, the shelf life is to be shortened.
- If the sealed part of pouch is open or have a hole, sterilize again and store.
⑧ Use-by date of the object for sterilizing packed by using sterilized fabric is 1 month
- User decides the packing in accordance with the usage of sterilized goods & duty cycle and if packing is
insufficient, the shelf life is to be shortened
- As its particle is wider than pouch and is not sealed completely, it is easy to exposed to external environment
& virus.
- If packing is insufficient in storage or packing is open, keep it after re-packing & re-sterilization.
⑨ Chamber door should be closed without fail, regardless whether use or not.
- If door opened for long time, the heater for maintaining the inside temperature of chamber operates in
continuous and may cause breakdown of heater.

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Education for installation- Cautions

⑩ If sterilant contacts with skin, wash it with running water by using soap immediately.
-If sterilant contacts with hand, it reacts with white color after few seconds and may form blister on it by the
extent of it.
-If wash it with running water & soap before reacting with white color, you can prevent the reaction.
-Even reacted with white color, it can be itself again as time pass by (Excessive blister occurrence may leave
scar on skin).
-First aid

A. If enter into eye If it enters into eye, wash it with a plenty of water for 15 minutes immediately.
Get doctor’s examination & treatment at once.

B. If contact with skin Take off contaminated clothes & shoes and remove it.
Wash it with a plenty of soapy water and remove chemical substance.
Clean contaminated cloths & shoes before re-use of it.
Get doctor’s examination & treatment at once

C. If inhale Escape far away from exposure source.


Get doctor’s examination & treatment at once.
Pay attention that if difficulty in breathing, you may need oxygen supply. If no breathing,
implement artificial respiration

D. If eat Let drink a plenty of water and don’t induce vomit.


Don’t do gastric lavage or induce vomit
Consider oxygen supply if inhale chemical substance.
E. Other directions of doctor Get doctor’s examination & treatment at once.

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Education for installation- Cautions

⑪ When sterilize a lot of the object for sterilizing which has cold metal component, wet over error may occur.
- If you intend to sterilize the object for sterilizing which has a lot of metal component or big volume object for
sterilizing which has metal component, it is recommended that you put it in chamber for about 5~10 minutes
and after warning up, implement the sterilization.
-If sterilize the object of cold metal component in big Q’ty, the sterilant may be condensed in metal component
and inserted excessively. After completion of sterilizing process, the sterilant may remain.
-When sterilize cold object for sterilizing in big Q’ty, not alone metal component, sterilize after warming up for
about 5~10 minutes and it helps to strengthen sterilizing power, can decrease the cause for Error occurrence.
⑫ Keep the sterilant refrigerated endways
-Special cap for gas emission inserted in the upper part of sterilant bottle and if keep it upside down, no gas
emission and the sterilant may flow out.

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SERVICE
Replacing Consumables

Supplies replacement cycle


Check Replace Calibration
Unit Description
Cycle Check Cycle Replace Cycle Calibration

Front Door Door Silicon Ring 3000 √ 5400 √ -

Chamber Heat Cable 1 year √ 5 year √ -

Solenoid Valve 3000 √ 6000 √ -


HPS
Heater 1 year √ 5 year √ -

Baratron Gauge 1000 √ - - 2000 √

Vacuum Valve 3000 √ 6000 √ -

Vacuum Pump Oil 500 √ 1000 √ -


Vacuum
Oil Mist Filter 500 √ 1000 √ -

Carbon Filter 500 √ 1000 √ -

Vacuum Pump 1000 √ 9000 √ -

Fillter 1000 √ 6000 √ -


Vent
Solenoid Valve 1000 √ 6000 √ -

Plasma Plasma Housing 1000 √ 6000 √ -

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Replacement of consumables

History management of consumables replacement


① Purpose
-For replacement history management of consumables & replaced parts during use of product.
②Input time
-When replace general consumables & parts due to breakdown, input after finishing examination & work for
replacement
③How to input
-Touch sterilizer (a) part on the star-up screen of LCD window by hand.
-Touch consumables management part (b) by hand.
-Choose relevant part and touch ‘Replace confirm’.
b

a
Choose Relevant part

c
Touch Sterilizer once Touch Consumables Touch Replace confirm once.
management once.

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Replacement of consumables - Chamber door silicone ring

How to replace consumables

1. Chamber door silicone ring


1) Necessary item: silicone ring, water tissue
2) How to replace
-Open the door and remove silicone ring-> Remove foreign substance in inserting part-> Insert silicone ring
from the middle of lower part-> Insert the end part with interlocking the inserted part at first-> Remove foreign
substance of silicone ring (When insert silicone ring, insert it naturally so that it is not stretched)

Remove silicone ring Remove silicone ring Remove foreign substance

Insert silicone ring Insert silicone ring complete inserting of silicone ring Remove foreign substance

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Replacement of consumables- Chamber door silicone ring

3) Check after replacement


- Close the door-> Enter into expert mode-> Vacuum pump ON-> Vacuum valve ON-> Confirm the sound of
air streams into at the part of door (within 5 seconds)-> Vacuum up to 0.5Torr -> Vacuum valve OFF-> Confirm
the sound of air streams into at the part of door-> Vent valve ON-> Confirm door open-> Vent valve OFF.

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Replacement of consumables- Injection valve
2. Injection valve
1) Necessary item: Injection valve, Universal spanner 2EA, Flat screwdriver, Nipper, Compressor, Sleeve
2) How to replace
-Turn off main power, separate the cover of right side and then, wait until the temperature of injection
chamber cooling down (About 1 hour)
-Cut out the power supply line of injection valve with keeping away from the valve by about 20㎝ distance.

Cut off power supply line

Be careful about the burn skin by the heat of injection chamber

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Replacement of consumables- Injection valve

-After confirming the temperature of injection chamber declined, separate the valve by using spanner.

Separate nut Separate nut Separate mail connector Separate mail connector

Be careful about the burn skin by the residual of hydrogen peroxide in the tube
(Work with wearing protection gloves).

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Replacement of consumables- Injection valve
-Separate 2 bolts (a) at the bottom side of valve by flat screwdriver

Separate bolt Separate Valve


a

Be careful about the direction

-Assemble the valve by using spanner with a care about the direction of valve for replacement.
-Fix 2 bolts (a) at the bottom side of valve by flat screwdriver.
-Peel off the sheath of power supply line with about 5mm length, insert sleeve, compress by compressor and
connect the line with the valve
(confirm if compression is done without problem through pulling out the line by hand)

Tighten nut Fix bolt Tighten nut Connect power supply line
a

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Replacement of consumables- Injection heater
3. Injection heater
1) Necessary item: Injection heater, Flat screwdriver, Phillips screwdriver, Cable tie, Nipper
2) How to replace
-Turn off main power, separate the cover of right side and then, wait until the temperature of injection
chamber cooling down (About 1 hour)
-Separate the power supply line of injection valve from terminal block (No.228, No.235)
-Cut out the cable tie which is fixed at power supply line
-After confirming the temperature of injection chamber declined, loosen out 1 bolt for fixing heater at
injection chamber.
-Insert the heater for replacement and insert 1 bolt for fixing.
-Fix the power supply line by using cable tie.

Separate power supply line Separate bolt Separate heater Fix bolt after inserting heater Connect power supply line

3) Check after replacement


-After main power ON, confirm the temperature increased on injection temperature controller.
-Confirm if the temperature is 170℃±5℃ after having warming up time for about 30 minutes.

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Replacement of consumables- Vacuum gauge
1) Necessary item: Vacuum gauge, Flat screwdriver
2) How to replace
-DC Power OFF -> Separate 2 bolts (a) at connector of gauge-> Separate connector-> Separate clamp (b) at
connector -> Separate vacuum gauge -> Insert center ring into the vacuum gauge for replacement and press
toward the chamber.

Work after confirming if the inside of chamber is atmospheric pressure.


(If separate vacuum gauge in the vacuum state of the inside of chamber, faulty vacuum gauge may
occur)

a c
b
Must! Work after DC power OFF (If separate or insert the connector in the state of power ON, faulty
vacuum gauge may occur).

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Replacement of consumables- Vacuum gauge
3) Check after replacement
-DC power ON->Confirm number indication on panel meter->Close the door in the state of no foreign
substance in the inside of chamber
->Prepare stop watch->Enter into expert mode->Vacuum pump ON->Measure the time by stop watch at the
same time of vacuum valve ON-> Measure the reaching time of pressing meter to 0.5 Torr->Vacuum pump
OFF ->Vacuum valve OFF->Confirm door open->Vent valve OFF

-Reaching time to 0.5 Torr should be within 1.4 minutes ±10.

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Replacement of consumables- Vacuum valve
5. Vacuum valve
1) Necessary item: Vacuum valve, Nipper, Sleeve, Compressor.
2) How to replace
-DC Power OFF-> Separate the covers of left & back side-> Cut out about 30cm of vacuum valve power
supply line from the valve ->Loosen 2 clamps [Chamber & connecting part (a), plasma & connecting part (b)]
of vacuum valve and separate the valve
->Locate the valve for replacement in between chamber & plasma and fix by clamp after inserting center ring
->Peel off the sheath of power supply line with about 5mm length and connect the valve line by using
sleeve (c.)
(Black color is + and confirm if compression is done without problem through pulling out the line by hand).

c
a

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Replacement of consumables- Vacuum valve
3) Check after replacement
-Turn on DC power, operate vacuum valve in expert mode and confirm by sound whether it is working or not
-Operate vacuum pump & vacuum valve in expert mode, confirm if it is working normally or not, close the
door and confirm if the pressure increased.
-Operate vent valve untill the door open and then, stop the operation of vent valve.

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Replacement of consumables- Vacuum pump oil
6. Vacuum pump oil
1) Necessary item: Vacuum pump oil, Spanner 13mm, Flat screwdriver, Oil cask, Funnel
2) How to replace
-Cut main power supply and separate left, right, back side covers of product->Separate the clamp (a) at the
upper part of plasma chamber (Connected with vacuum valve)->Separate the connecting clamp (b) of
vacuum valve & bellows ->Separate 4 vibration dampener fixing nuts (c, d, e, f) of vacuum pump
->Separate the power line of vacuum pump from terminal block (g).

c d g

a
b

e f

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Replacement of consumables- Vacuum pump oil
- Take out vacuum pump from the product  Place it on the table with having the back side of pump lower 
Prepare the cask with wide entrance & about 1.5L capacity for receiving oil  Discharge oil by loosening
drain bolt (a) at lower of pump back side  -> Discharge oil & residual substance to the end by slanting the
pump toward back side  Insert drain bolt (a) of vacuum pump  Lay down the pump in horizontal 
Remove oil cap (b) at upper right side of vacuum pump back side
 Charge oil  confirm & adjust oil gauge at back side (upper limit) and charge  Insert oil cap (b)
Be careful about any injury & damage of product due to the fall of pump during the
movement of vacuum pump & the drain of oil.
a
Be careful about
the burn skin as
oil temperature
can be high.
Rear lower dropping Remove the drain bolt Discharge oil Insert drain bolt
a

Remove oil cap Charge oil Upper limit check Insert oil cap
b b

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Replacement of consumables- Vacuum pump oil
-Place safely the vacuum pump in the product, adjusting it with vibration dampener volts->Tighten 4 vibration
dampener fixing bolts (a, b, c, d) and fix the pump-> Assemble the power line at terminal bloc (e) -> Insert
center ring into lower side of vacuum valve and fix plasma chamber by clamp (f) ->Insert the bellows with
center ring into the inhale part and fix by clamp (g).

e
a b
f
g

c d

Slide50 Medical device innovation!


Replacement of consumables- Vacuum pump oil
3) Check after replacement
-Main power supply ON-> DC power ON-> Enter into expert mode ->Vacuum pump ON-> Confirm the
operation of pump (If normal, operate for about 10 minutes)
->Vacuum pump OFF-> Close the door in the state of no foreign substance in the inside of chamber ->
Prepare stop watch ->Enter into expert mode->Vacuum pump ON->Measure the time by stop watch at the
same time of vacuum valve ON-> Measure the reaching time of pressing meter to 0.5 Torr->Vacuum pump
OFF ->Vacuum valve OFF->Confirm door open->Vent valve OFF

-Reaching time to 0.5 Torr should be within 1.4 minutes ±10

Slide51 Medical device innovation!


Replacement of consumables- Oil mist filter
7. Oil mist filter
1) Necessary item: Oil mist filter, Hex wrench (2mm, 4mm)
2) How to replace
-Separate the back cover->Remove the clamp (d) which is connected with vacuum pump-> Separate the filter
from pump-> Separate the clamp (b) which is connected with carbon filter-> Remove the cap of filter case by
hex wrench (2mm)
->Separate the mist filter by hex wrench (4mm)->After inserting the mist filter for replacement, fix the filter by
hex wrench (4mm)->Fix the cap of filter case by hex wrench (2mm)->After inserting center ring (c) into the
clamp (b) which is connected with carbon filter, connect it with carbon filter
->After inserting center ring into vacuum pump exhaust outlet in the product, connect it by clamp (a).

a b

Slide52 Medical device innovation!


Replacement of consumables- Oil mist filter
3) Check after replacement
-Enter into expert mode ->Vacuum pump ON->Vacuum valve ON->Confirm if oil vaporized things vent itself
from mist filter-> Vacuum valve OFF ->Vacuum pump OFF -> Vent Valve ON-> Confirm the door open ->
Vent valve OFF-> Return to the start up screen

Slide53 Medical device innovation!


Replacement of consumables- Plasma chamber
1) Necessary item: Plasma Chamber, Flat screwdriver
2) How to replace
-Main power supply OFF-> Separate the covers of right & back side -> Remove the bolts of power line
(up, down) which is connected with plasma chamber -> Separate the clamp at upper & lower end of plasma
chamber -> Insert center ring into lower end of plasma chamber vacuum valve for replacement and fix by
clamp->Insert bolt of power line into plasma chamber ->Fix the bellows at lower end of plasma chamber by
using clamp.

Remove bolt (Down) Remove bolt (up) Remove clamp (Down) Remove clamp (up)

Insert center ring Fix clamp (Down) Insert center ring Fix clamp (up)

Slide54 Medical device innovation!


Replacement of consumables – Plasma chamber
3) Check after replacement
-Main power ON->DC power ON->Enter into expert mode->Plasma ON->Confirm plasma occurrence (a)
->Plasma OFF

Be careful about high voltage when plasma occurs

Slide55 Medical device innovation!


Replacement of consumables – Vent filter
11. Vent filter
1) Necessary item: Vent filter, Universal spanner
2) How to replace
-Separate the back cover->Loosen the clamp (a) of vent valve and separate it from chamber-> Separate the
filter (b) of vent valve by using spanner -> Insert the filter for replacement by hand and tighten by using
spanner-> Fix vent valve with upturned by tightening clamp (a) like the below pictures.

Remove the clamp b Remove the filter Insert the replacement filter

a
Fixed filter fixed Vent valve

Slide56 Medical device innovation!


Replacement of consumables- Vent filter
3) Check after replacement
-Enter into expert mode->Vacuum pump ON->Vacuum valve ON->Confirm if press meter reaches 0.5 Torr
->Vacuum pump OFF->Vacuum valve OFF-> Vent valve ON (Confirm vent sound) ->Confirm the door open
-> Vent valve OFF

Slide57 Medical device innovation!


Corrective measure for Error
1. Screen of occurrence

Door Error

2. Main causes for error occurrence


1) If implement the sterilization in the state of door opening
2) Poor quality of door switch
3) Disconnection of door switch cable

Slide59
Corrective measure for error – Door error
1. Door Error
Necessary item: Door switch, Cable, Multi meter, Flat screwdriver, Hot-melt gun.
1) If implement the sterilization in the state of door opening
-Action: Close the door and sterilize again
2) Poor quality of door switch
-Confirm: Set up the multi tester to make buzz sound -> Let the measuring bar of multi tester contact with
switch terminal block (a, b) -> Repeat door switch (c) ON & OFF -> Judge door switch quality by multi tester
-Action: Separate the left cover->Remove hot melt (d) at the inside of door switch product ->Separate door
switch to the front side of product -> Separate the connected terminal block (a, b) ->Insert again the
terminal block (a, b) into door switch for replacement ->Insert the switch at the front side of product ->
Fix by hot melt

d e
c a
f
b

Slide60 Medical device innovation!


Corrective measure for error – Door error

3) Disconnection of door switch cable


-Confirm: If door switch is normal after checking for the cause No.2 but still the faulty phenomenon continued,
confirm the disconnection between door switch terminal block (a) & No.218 of terminal block (f) -> Judge the
defect of cable disconnection through confirming the disconnection between switch terminal block (b) &
No.212 of terminal block (e).

Slide61 Medical device innovation!


1. Screen of occurrence

Cancel

2. Main cause for error occurrence


1) If user push ‘Cancel’
2) If the part of ‘Cancel’ touched by careless handling

Slide62
Corrective measure for error- Cancel Error
2. Cancel Error
1) If user push ‘Cancel’
-Action: After settlement of user’s cancel purpose, implement the sterilization again.
2) If the part of ‘Cancel’ touched by careless handling
-Action: Be careful about touching on the part of ‘Cancel’ and implement the sterilization again.

☆ The cases need for ‘Cancel’ during sterilizing process


-If the object for sterilizing which can’t be sterilized inserted
-If packing of the object for sterilizing is wrong
-If the moisture of object is not removed and inserted
-If implement the sterilization without having the object for sterilizing by user’s carelessness
-If any doubt that the object for sterilizing inserted in chamber with more than 70% of its space.
-If any doubt about the disorder of product on the way of sterilizing process

Be careful that no touch ‘cancels’ on the way of sterilizing process except above reasons.

Slide63 Medical device innovation!


1. Screen of occurenence

Injection
Heater Error

2. Main causes for error occurrence


1) Ill-posed problem of temperature controller #1
(Fiducial valve of temperature)
2) Ill-posed problem of temperature controller #2
(Range of Error)
3) Defect of injection heater
4) Defect of SSR
5) Defect of temperature controller
6) Defect of temperature sensor
Slide64
Corrective measure for error – Injection Heater Error
3. Injection Heater Error
1) Ill-posed problem of temperature controller #1 (Fiducial set-up value)
-Confirm: If temperature does not increase even after more than 2 hour’s pass from the time of main power
supply to the product, confirm if the set-up value of temperature controller (a) is 170.
-Action: If temperature set-up is not 170, push the cursor (b) on the below end of temperature controller front
side, set-up as 170 and confirm temperature increase within 30 minutes.

a b

2) Ill-posed problem of temperature controller #2 (Range of Error)


-Confirm: If the set-up value is 170 and temperature indication is within 170±5℃, push SET button at left side
of temperature controller front side end for 3 seconds->confirm ‘Disp’ on indication window->Push SET
button once-> Confirm G.CTL indication->Push ‘Up’ cursor at right end 4 times->Confirm G.ARM indication
-> Push SET button 5 times->Confirm AL-1 value is 100-> Push SET button once->confirm AL-2 Value is
200-> Push SET button for long ->confirm the start-up screen
-Action: Set AL-1 Set-up value at 100, AL-2 at 200

Push for 3 seconds Push once Push 4 times Push 5 times Push 1 times Confirm the set-up value

Slide65 Medical device innovation!


Corrective measure for error- Injection heater
3) Defect of injection heater
Necessary item: Injection heater, multi meter, Flat screwdriver, Phillips screwdriver, Nipper, Cable tie.
-Confirm: If normal after confirmation of cause (1) & (2) and output signal (b) occurred on temperature
controller & SSR, confirm the voltage of 220v at both end of NO.228 & No. 235 of terminal block by multi
tester and if injection heater is not heated even in normal voltage occurrence, judge as the defect of heater

b
a

Slide66 Medical device innovation!


Corrective measure for error- Injection heater
-Action: DC power OFF-> Main power OFF-> Separate heat cable of No.228 & No.235 of terminal block
->Remove cable tie in which power supply line fixed -> Separate bolt for heater fixing (c) -> Separate heater ->
Insert heater for replacement -> Insert bolt for fixing (c) -> Connect heater power supply line of 2211 H with
No.228 of terminal block & 2221 H with No. 235 of terminal block-> Fix power supply line by using cable tie->
Main power ON->Confirm temperature increase on injection temperature controller->Confirm the temperature
170℃±5℃ after about 30 minutes.

221IH

222IH

Slide67 Medical device innovation!


Corrective measure for error- Injection heater
4) Defect of SSR
Necessary item: SSR board, Phillips screwdriver, Flat screwdriver.
-Confirm: If the input signal of temperature controlled (a) is confirmed but SSR signal (b) is not confirmed and
if SSR signal is confirmed but 220V at both end of No.228 & No.235 of terminal block by multi tester is not
confirmed, judge as the defect of SSR board.

a b

Slide68 Medical device innovation!


Corrective measure for error- Injection heater

-Action: Main power OFF-> Separate all the lines (a) connected at SSR board -> separate 4 bolts (b, c, d, e)
for SSR board fixing -> Separate SSR board -> Locate SSR board for replacement at the separated place ->
Insert 4 bolts (b, c, d, e) for replacement -> Connect all separated lines (a) at SSR terminal block as per the
drawing.

Before main power ON, reconfirm all the lines connected at terminal block
(Refer to P.101 of the drawing)

a d

c e

Slide69 Medical device innovation!


Corrective measure for error- Injection heater
5) Defect of temperature controller
Necessary item: Temperature controller, Phillips screwdriver
-Confirm: Even though temperature set-up value (a) on temperature controller is not normal and actual
temperature (b) is lower than the set-up value, the output signal (c) is not confirmed.

b
c

Slide70 Medical device innovation!


Corrective measure for error- Injection heater

-Action: Main power OFF-> Separate the covers of left & right side-> separate all the lines (d) connected at
terminal block of temperature controller in the middle by Phillips screwdriver ->Separate 2 bolts (e, f) for
temperature controller fixing -> Separate the controller toward front side of temperature controller
(Left side of product) -> Insert temperature controller for replacement -> Fix 2 bolts (e, f) for fixing ->
Connect all separated lines (d) as per the drawing.
-Set-up the temperature controller after completing the replacement of temperature controller
(refer to next page)

e f

Before main power ON, reconfirm all the lines connected at terminal block
(Refer to P.101 of the drawing)

Slide71 Medical device innovation!


Corrective measure for error – Set-up temperature controller for injection heater
5-1) Set-up temperature controller – For injection heater

Push 3 seconds

Push once Change the pages by pushing △, ▽ in each mode

Push 5 times Push 2 times Push once Push 3times Push once Push once
SET
SET
SET

All set after the completion


of the last set by pressing △ SET

*Explanation about button


1) SET : Mode Enter & Release
- Start-up mode enters & detailed item enter in SET

relevant mode.
- Release to the start-up state by pushing for long
after mode enter
- Store the set-up value
SET
2) ◁ : Change input position
3) ▽ : Page forward (down) & Input down
4) △ Page backward (up) & Input up

Slide72 Medical device innovation!


Corrective measure for error - Injection Heater Error
6) Cause: Defect of temperature sensor
Necessary item: Temperature sensor, Phillips screwdriver, Universal spanner, Nipper, Cable tie.
▷ Confirm: If actual temperature is not indicated on temperature controller and indicated as ‘bout,’ it is the
case of temperature sensor defect or disconnection of temperature sensor cable and should replace the
sensor.

Actual temperature

Slide73 Medical device innovation!


Corrective measure for error - Injection Heater Error
▷Action: Main Power OFF-> Separate the covers of left & right side -> Separate the connected lines at No. 18,
19, 20 of temperature controller terminal block in the middle from right side by Phillips screwdriver ->
Remove the cable tie which fix temperature sensor -> Wait until injection chamber temperature
cooling down-> Separate temperature sensor (a) by using spanner -> Insert temperature sensor for
replacement -> Fix temperature sensor by using spanner -> Wiring temperature sensor line to
temperature controller with fixing by cable tie -> Connect the red line of sensor at No.18 on the back
side of temperature controller -> Connect the blue line at No.19 & 20 respectively
(The blue lines can be reversed each other) -> Main power ON -> Confirm actual temperature value
on temperature controller

Temperature sensor

Slide74 Medical device innovation!


1. Screen of occurrence

Chamber
Heater Error

2. . Main causes for error occurrence


1) Ill-posed problem of temperature controller #1
(Fiducial valve of temperature)
2) ) Ill-posed problem of temperature controller #2 (Range of Error)
3) Defect of injection heater
4) Defect of injection heater
5) Defect of temperature controller
6) Defect of temperature sensor

Slide75
Corrective measure for error – Chamber Heater Error
4. Chamber Heater Error
1) Ill-posed problem of temperature controller #1 (Fiducial set-up value)
- Confirm: If temperature does not increase even after more than 2 hour’s pass from the time of main power
supply to the product, confirm it the set-up value of temperature controller (a) is 55
- Action: If temperature set-up is not 55, push the cursor (b) on the below end of temperature controller front
side, set-up as 55 and confirm temperature increase for about 2 hours.

a b

Slide76 Medical device innovation!


Corrective measure for error – Chamber Heater Error

2) Ill-posed problem of temperature controller #2 (Range of Error)


- Confirm: If the set-up value is 55 and temperature indication is within 55±5℃,
push SET button at left side of temperature controller front side end for 3 seconds  Confirm ‘Disp’ on
indication window  Push SET button once  Confirm G.CTL indication  Push ‘up’ cursor at right end 4
times  Confirm G.ARM indication  Push SET button 5 times  Confirm AL-1 value is 30  Push SET
button once  Confirm AL-2 value is 100 Push SET button for long  Confirm the star-up screen
-Action: Set AL-1 set up value at 30, AL-2 at 100.

Push for 3 Push once Push 4 Push 5 Push once Confirm the set-up value.
seconds times times

Slide77 Medical device innovation!


Corrective measure for error - Chamber Heater Error

3) Cause: Defect of chamber heater


Necessary item: Chamber heater cable, Silver-foil tape, Multi meter, Flat screwdriver, Nipper, Spanner (30mm)
2EA, Hex wrench (4mm), Sleeve & Compressor
- Confirm: If normal after confirming the cause No.1 & No.2 but SSR output signal of temperature controller
occurs, confirm 220v at both end of No.228 & No.225 of terminal block by multi tester. If the injection heater
is not heated in spite of normal voltage occurrence, judge as the defect of heater.

a b

- Action: Cut off main power supply and let the covers of side & back opening
 Separate the power line of heater cable from terminal block by using flat screwdriver
(No.227, No.234)  Pull out the line from duct and cut the cable tie of which power line fixed.

Slide78 Medical device innovation!


Measure for error - Chamber Heater Error
3) Defect of SSR
Necessary item: SSR board, multi meter, Phillips screwdriver
-Confirm: If the input signal of temperature controlled (a) is confirmed but SSR signal (b) is not confirmed and if
SSR signal is confirmed but 220V at both end of No.228 & No.235 of terminal block by multi tester is
not confirmed, judge as the defect of SSR board.

a b

-Action: Main power OFF-> Separate all the lines (a) connected at SSR board -> Separate 4 bolts (b, c, d, e)
for SSR board fixing -> Separate SSR board -> Locate SSR board for replacement at the separated
place -> Insert 4 bolts (b, c, d, e) for replacement -> Connect all separated lines (a) at SSR terminal
block as per the drawing.
Before main power ON, reconfirm all the lines
a d
connected at terminal block
b (Refer to P.101of the drawing)

c e

Slide79 Medical device innovation!


Measure for error - Chamber Heater Error
5) Defect of temperature controller
Necessary item : Temperature controller, Phillips screwdriver, Nipper, Cable tie.
-Confirm : Even though temperature set-up value (a) on temperature controller is normal and actual
temperature (b) is lower than the set-up value, the output signal (c) is not confirmed.
b
c

-Action: Main power OFF-> Separate the covers of left & right side-> Separate all the lines (d) connected at
terminal block of temperature controller in the middle by Phillips screwdriver -> Separate 2 bolts (e, f)
for temperature controller fixing -> Separate the controller toward front side of
temperature controller (Left side of product) -> Insert temperature controller for
replacement -> Fix 2 bolts (e, f) for fixing -> Connect all separated lines (d) as per the
drawing.
Before main power ON, reconfirm all the lines connected at terminal block
f
(Refer to P.101 of the drawing)
e
-Set-up the temperature controller after completing the replacement of temperature
d controller (refer to next page)

Slide80 Medical device innovation!


Measure for error-Set-up temperature controller (Chamber heater)
)
5-1) Set-up temperature controller –For chamber heater

Push 3 seconds

Push once Change the pages by pushing △, ▽ in each mode

Push 5 times Push 2 times Push once Push 3 times Push once Push once
SET
SET

All set after the completion


*Explanation about button of the last set by pressing △ SET
SET

1) : Mode Enter & Release


SET

- Start-up mode enters & detailed item enter in relevant mode.


- Release to the start-up state by pushing for long after SET

mode enter
- Store the set-up value
2) ◁ : Change input position
SET
3) ▽ : Page forward (down) & Input down
4) △ Page backward (up) & Input up

Slide81 Medical device innovation!


Measure for error- Chamber Heater Error
6) Cause: Temperature Sensor for error
Necessary item: Temperature sensor, Phillips screwdriver
▷ Confirm: If actual temperature is not indicated on temperature controller and indicated as ‘bout,’ it is the case
of temperature sensor defect or disconnection of temperature sensor cable and should replace the sensor.

Actual temperature

▷Action: Main Power OFF-> Separate the covers of left & right side -> Separate the connected lines at No.
18, 19, 20 of temperature controller terminal block in the middle from right side by Phillips
screwdriver -> Remove the cable tie which fix temperature sensor -> Wait until injection
chamber temperature cooling down-> Separate temperature sensor (a) by using spanner ->
Insert temperature sensor for replacement -> Fix temperature sensor by using spanner ->
Wiring temperature sensor line to temperature controller with fixing by cable tie -> Connect the
red line of sensor at No.18 on the back side of temperature controller -> Connect the blue line
at No.19 & 20 respectively (The blue lines can be reversed each other) -> Main power ON ->
Confirm actual temperature value on temperature controller
Temperature Sensor line

Slide82 Medical device innovation!


1. Screen of occurrence

Change H2O2

2. Main causes for occurrence


1) If any shortage of sterilant in the inside of product
2) Disconnection of level sensor line
3) Defect of level sensor bloc

Slide83
Measure for error - Charge H2O2

5. Change H2O2
Necessary item: Sterilant, multi meter, Sensor cable, Universal spanner, Flat screwdriver
1) If any shortage of sterilant in the inside of product
-Action: Supplement sterilant and implement sterilization.
2) Disconnection of level sensor line
- Confirm: Separate the cover of left side-> Confirm if LED (a) lighting of main board level sensor bloc is on or
not (If sterilant charged and sensor line connected, LED is lighting on) -> If LED is lighting off, confirm whether
it is disconnected or not by applying multi tester at level senor line at the upper part of
sterilant storage tank and No.1 (b) & No.2 (c) of main board level sensor bloc
b

a
d
c

- Action: Remove hot melt & nut for fixing sensor terminal bloc at the upper part (d) of
sterilant shortage tank -> Separate the sensor line which is connected at No.1 & No.2 of main board level
sensor bloc -> Regardless of polarity, connect the sensor line for replacement at No.1 & No.2 the sensor line
for replacement at No.1 & No.2 of main board level sensor bloc -> Tighter terminal block of level sensor at
the upper part of sterilant storage tank -> Fix by hot melt.

Slide84 Medical device innovation!


Measure for error - Charge H2O2

3) Defect of lever sensor bloc


Necessary item: Level sensor bloc, Phillips screwdriver, Flat screwdriver
-Action: DC power OFF -> Separate 1 bolt (a) for fixing level sensor bloc of main board -> Separate the
connected lines (b, c) at bloc -> Remove the bloc from main board-> Re-connect the lines at block for
replacement ->Insert the block into main board and then, fix by bolt (a)

Slide85 Medical device innovation!


1. Screen of occurrence

H2O2 Supply
Error

2. Main causes for occurrence


1) If any shortage of sterilant during the implementation of
sterilizing process
2) Defect of injection valve

Slide86
Measure for error- H2O2 Supply Error
6. H2O2 Supply Error
Necessary item: Injection valve, Universal spanner, Nipper, Phillips screwdriver, Cable tie, Sleeve & Compressor
1) If any shortage of sterilant during the implementation of sterilizing process
-Action: Sterilize again after supplement of sterilant
2) Defect of injection valve
-Confirm: Enter into expert mode ->ON/OFF of injection valve for 2~3 times (Confirm operating sound)->If no
operating sound heard or the same error occurs at the time of re-sterilization after the supplement of sterilant
& operating sound heard, judge as defect of injection valve
-Action: Main power OFF -> Separate the cover of left side -> Wait until the
temperature of injection valve cooling down (about 1 hour) -> Cut
out the power line of injection valve with about 20cm distance
from valve -> Separate valve by using spanner.
Cut the power line

Separate nut Separate nut Separate mail connector Separate mail connector

Slide87 Medical device innovation!


Replacement of consumables – Injection valve
-Separate 2 bolts at the bottom of valve by Phillips screwdriver

Separate bolt Separate valve


a Care about direction

-Assemble the valve by using spanner with caring about direction of valve for replacement
-Fix 2 bolts at the bottom of valve by phillips screwdriver
-Peel off about 5mm of power supply line, insert the sleeve, compress by compressor and connect the valve
line (Confirm if compression is done without problem through pulling out the line by hand)

Tighten nut Fix bolt Tighten nut Connect power supply line
a

Slide88 Medical device innovation!


1. Screen of occurrence

Wet Over Error

2. Main causes for occurrence


1) If the inserted object for sterilizing contains a plenty of moisture
2) If the material which can absorb moisture inserted
3) Measures for reference after checking the degree of vacuum
-Foreign substance of door gasket, Residual moisture of inside,
Loosen clamp of parts, Defect of plasma chamber, Defect of
vacuum gauge, Defect of vacuum pump

Slide89
Measure for error- Wet Over Error
7. Wet Over Error
1) If the inserted object for sterilizing contains a plenty of moisture
-Action: Remove the moisture of object for sterilizing and sterilize again

2) If the material which can absorb moisture inserted (Paper, Fabric, Wood, Sponge, Powder etc.)
-Action: Remove the materials which can absorb moisture and sterilize again

※ Confirm 1, 2 in common: Empty the inside of chamber, implement self-diagnosis and if it is completed
within normal time (5 minutes), judge it is inserting problem

On the way of self-diagnosis

Slide90 Medical device innovation!


Measure for error- Wet Over Error

◈ Check procedure if Wet over Error occurs after the implementation of self-diagnosis
Necessary item: Stopwatch
-Close the door after confirming empty state of chamber inside without foreign substance -> Prepare
stopwatch -> Enter into expert mode -> Vacuum pump ON -> Measure the time by stopwatch at the same
time of vacuum valve ON at the upper part of left side electronic display and measure the time to reach
0.5 Torr-> Vacuum valve OFF -> Vacuum pump OFF-> Vent valve ON-> Confirm the door open ->
Vent valve OFF

※ Reaching time to 0.5 Torr should be within 1.4 minute ±10.

Slide91 Medical device innovation!


Measure for error- Wet Over Error
Necessary item: Stopwatch
1) If over standard time (Over than 1.50 minute)
-Enter into expert mode -> Vacuum pump ON-> Vacuum valve ON-> Confirm 0.5 Torr at pressing meter (a)
-> Vacuum valve OFF-> Confirm pressure rising numerical value (If rising within 0.2 Torr for 10 seconds, it is
normal)

1-1) If rising over than 0.2 Torr for 10 seconds, check the below
① Open the door and if door gasket floated or foreign substance contained, remove it.
② Open the door and confirm if moisture or residual of sterilant exist in the inside of chamber
-If moisture or residual of sterilant exist, let the vacuum to 0.5 Torr for 4~5 times and remove.

Slide92 Medical device innovation!


Measure for error- Wet Over Error
③ Confirm clamp tightening state of each part
As the clamp of injection chamber is very hot, be careful.

Injection chamber Vent valve

Vacuum vale
Vacuum gauge

Temperature sensor

If not solve in spite of above measure, contact head office.

1-2) If rising below 0.2 Torr for 10 seconds, check the below
① Enter into expert mode-> Vacuum pump ON -> Vacuum valve ON-> Confirm 0.5 Torr at pressing meter ->
Vacuum pump OFF-> Confirm pressure rising numerical value (Vacuum valve should be opening)

Slide93 Medical device innovation!


Measure for error- Wet Over Error

② If rising over than 0.2 Torr for 10 seconds, check the assembling state of plasma chamber
-Tighten NW25 flange (a) at both ends of plasma chamber as much as possible
③ Confirm clamp tightening state of each part
Plasma chamber clamp

Vacuum
pump clamp

Slide94 Medical device innovation!


Measure for error- Wet Over Error
④ If not solve in spite of above measure, it can be regarded as shortfall of performance or fiducial value fells
through and need to contact head office for replacement of relevant parts.
Necessary item: Vacuum gauge, Flat screwdriver
-Replacement vacuum gauge: DC power OFF-> Separate 2 bolts (a) of connector at gauge -> Separate
connector -> Separate clamp of vacuum gauge (b) -> Separate vacuum gauge -> Inert center ring into
gauge for replacement (c) and adhere it to the chamber -> Fix by clamp (b) -> Insert connector ->
Insert 2 bolts (a) for fixing connector

Check the inside of the chamber is at atmospheric pressure after work


(Failure to separate the internal chamber of the vacuum when the vacuum gauge, vacuum gauge can fly)

b a c
Sure ! DC power OFF and will work
(Power connector from the state when you remove or insert a vacuum gauge defects)

Slide95 Medical device innovation!


Measure for error- Wet Over Error
Necessary item: Vacuum pump, Spanner 13mm, Phillips screwdriver
Replacement of vacuum pump
-Shut off main power and separate left & right side covers of product -> Separate the clamp (a) at the upper
part of plasma chamber (connected with vacuum valve) -> Separate the connecting clamp (b) between
vacuum pump & bellows-> Separate 4 vibration dampener fixing nuts (c, d, e, f) of vacuum pump-> Separate
the power line of vacuum pump from 3p terminal bloc (g)

c d g

a
b

e f

Slide96 Medical device innovation!


Measure for error- Wet Over Error

-Securely place the vacuum pump in product in line with vibration dampener bolts-> Fix pump by tightening
4 vibration dampener fixing bolts (a, b, c, d) -> Assembler power supply line at terminal block (e) ->
Fix plasma chamber by clamp (f) with inserting center ring into the bottom of vacuum valve ->
Fix the bellows at inhale part with inserting center ring.

e
a b
f
g

c d

Slide97 Medical device innovation!


Measure for error- Wet Over Error
Necessary item: Vacuum gauge, Flat screwdriver
2) If fail to meet the standard time (below 1.30 minute)
-It is the case of fiducial value fell through and replace vacuum gauge
-Replacement of vacuum gauge: DC power OFF -> Separate 2 bolts (a) at connector of gauge-> Separate
connector-> Separate clamp of vacuum gauge (b) -> Separate vacuum gauge-> Insert center ring into gauge
for replacement (c) and adhere it to the chamber-> Fix by clamp (b)-> Insert connector-> Insert 2 bolts (a) for
fixing connector

Check the inside of the chamber is at atmospheric pressure after work


(Failure to separate the internal chamber of the vacuum when the vacuum gauge, vacuum gauge can fly)

b a c
Sure ! DC power OFF and will work
(Power connector from the state when you remove or insert a vacuum gauge defects)

Slide98 Medical device innovation!


Drawing
Drawing – PART
1) Electrical Schematic Diagram – Embedded

Slide100 Medical device innovation!


Drawing - Embedded
2) Electrical Schematic Diagram - DC Line

Slide101 Medical device innovation!


Drawing - Embedded
3) Electrical Schematic Diagram - AC Line

Slide102 Medical device innovation!


DATA Management
DATA Management -Program upgrade
1) Program upgrade
- Necessary item: USB memory (FAT32 format)-Program supplied from head office stored
- Purpose: To use the product with upgraded program
- Method
① Store newest program supplied from manufacturer in USB memory and prepare
(Format with FAT32 of USB memory)
② Enter into expert mode->Touch ‘Expert mode’ twice
③ If the words of ‘Insert USB memory’ shown, insert USB into the back side of LCD window
(opening door when supply sterilant)
④ Confirm the words of ‘upgrade is completed’ and then, DC power OFF and remove USB memory
⑤ DC power ON and use the product

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DATA Management -Program upgrade

Insert USB memory Remove USB memory


Touch screen once Input password Touch screen twice Confirm message
after DC power OFF

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DATA Management -LOG DATA Back-Up
2) LOG DATA Back-Up
- Necessary item: USB memory (FAT32 format)
- Purpose: Implement on the separate request of head office (manufacturer) for
apprehending the state of equipment disorder & management
- Method
① Prepare USB memory for back-up of Log Data
(Prepare USB memory in the blank state with format of FA 32)
② Insert the prepared USB memory into the back side of LCD window
(opening door when supply sterilant) in the start-up screen of product

Booting Window Insert USB memory LOG DATA Back-Up

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DATA Management -LOG DATA Back-Up

- Method
③ If USB memory inserted, Log Data back-up automatically.
The matter that require attention at this moment is you do not back up without separate request of
Head office (manufacturer) since the data does not remain in the product and store in USB memory only in
the state of back-up.
④ Remove USB memory
- Start-up screen->Insert USB memory->LOG DATA back-up

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How lumen
1) How lumen
Necessary item : Lumen, Chemical Indicator, Pouch, Scissors, Sealer
- Lumen test to same way to picture

(Other lumen is tested in the same way )

LUMEN Preparation CI Insertion Close

Sterilize
PACKING OPEN CHECK

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Manufacturer Contact
Address and Contact

BEYONDMEDI Co., Ltd.


1. Address
#401-2 Hanshin IT Tower 2 Cha, Gasan-dong, Geumcheon-gu, Seoul,
Korea 153-712

2. Contact
Email : beyondmedi@beyondmedi.com

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