Professional Documents
Culture Documents
APS-1X APS-2X
H2O2 Low Temperature Plasma Sterilizer
Maintenance Manual
Document No. TD‐PS‐X002‐002‐EN V2.00
Date of publication: 2015‐6‐1
Welcome use H2O2 Low Temperature Plasma Sterilizer. To maximize the performance of the
equipment, please carefully read and comply with this manual for safety and operational pur‐
pose.
‐ 2X H2O2 Low Temperature Plasma Sterilizer.
This manual is applicable to APS ‐1X/ APS
TD‐PS‐X002‐002‐EN
Contents
1. CAUTIONS AND ATTENTIONS 3
1.1. ATTENTIONS 3
1.2. SAFETY SIGNS 5
2. SYSTEM MAINTENANCE 5
2.1. MANUAL OPERATION 6
2.2. TIME SETTING 6
2.3. MAINTENANCE MODE 7
2.4. PROGRAM EDIT 7
2.5. SYSTEM INFORMATION 8
2.6. CASSETTE MAINTENANCE 8
2.7. ALARM SET 10
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1. Cautions and attentions
Please strictly obey the following instructions during the operation.
1.1. Attentions
Read carefully the following information while operating or maintaining the sterilizer. Please
pay attention to these signs wherever they appear.
It indicates that please pay high attention.
It indicates that please obey or damage may happens on sterilizer.
It indicates that please strictly obey or human safety may be endangered.
Operators should always keep the following information in mind before operation.
Wherever the sign appears, please look up the relevant information in this
manual to clarify the potential danger and take proper measures.
Anyone in any situation is not allowed to tear off any page of this manual. Please
contact us promptly if this manual cannot help you with the sterilizer problems. Please make
sure your manual is updated.
Please store this manual at ventilated and dry place preventing damps and heat.
The sterilizing agent contains H2O2 which could permeate into and temporarily
skin. Please wear gloves that are made of latex or ethylene while handle the sterilizing agent.
Handle the used cassettes properly. In any case of that your skin contacts the sterilizing
agent; please wash it by plenty of water immediately for 5 minutes. If anyone accidently
swallows the agent please drink plenty of water and turn to the doctor.
The following articles (including but not limited) mentioned are not applicable to
this H2O2 low temperature sterilizer:
a. APS‐1X :
The stainless steel tubular instruments with inner diameter<1mm and length>500mm.
The Teflon tubular instruments with inner diameter<1mm; length>2000mm
APS ‐ 2X :
The stainless steel tubular instruments with inner diameter<0.8mm and length>300mm.
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The Teflon tubular instruments with inner diameter<1mm; length>1000mm
b. Hygroscopic materials (i.e. wooden instrument, cellulose, cotton fabric, gauze, etc.);
c. Disposable instrument (i.e. disposable waterproof fabric, disposable surgical gown, etc.);
d. Liquid, cream, oil, and powder;
e. Half‐dried items;
f. The tubular instruments with one sealed end;
g. Implants;
h. The instruments that could not bear vacuum pressure;
i. The instruments that are only allowed to be sterilized by pressure steam sterilizer or EO
sterilizer;
j. The instruments that contain complicated construction e.g. sealed bearing;
k. The instruments that contain nylon surface;
l. The soft endoscopes with fossilized or damaged surface that their materials cannot be de‐
termined.
We do not make any explicit or implied guarantees or warranties for any damage caused by
biogenetic or secondary injury and improper operation.
Please inquire our engineering department if you are not sure whether your instrument can
be processed by this sterilizer.
All instruments must be thoroughly washed and dried, and properly packed by
specified packing material or container before being put into chamber for sterilization.
To guarantee the performance of the sterilizer, it is necessary to carry out regular
and preventive maintenance.
Any product adjustment or maintenance must be left to qualified staff. Improper
maintenance or unauthorized installation of spare parts may cause personal injury.
Cut off all power supply of the sterilizer before maintenance.
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1.2. Safety signs
2. System maintenance
There are three maintenance cycles installed in the system. User could push the ‘Maintenance’
button on the main menu to view.
Main menu
Push the ‘Maintenance’ button to enter into the maintenance page:
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Maintenance page
2.1. Manual operation
Push the ‘Manual’ button on the maintenance page to enter into manual operation page, manu‐
al operation is only used for debugging single component. It cannot be operated during the steri‐
lization cycle.
Manual operation
The buttons on this page represent the corresponding component. Push the button to turn on
the component, while push it again to turn it off. Push the ‘Return’ button to go back to the main
menu.
To guarantee the safety of the entire system, we have set protective action for im‐
portant components. It might cause some components cannot be controlled manually. If you
have any questions, please contact us.
2.2. Time setting
Push the ‘Time setting’ button to enter into the time setting page. The date and time can be ed‐
ited in this page end by pushing the ‘OK’ button.
System clock
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2.3. Maintenance mode
Push the ‘Mode’ button to enter into ‘Password’ page. Input password ‘1010’ and push ‘ENT’
button to enter into the ‘Maintenance options’ page. On this page, you have four operation or‐
ders. Like the following pictures:
Password input Maintenance options
2.4. Program edit
On maintenance options page, push ‘Program edit’ button to enter into the program edit page.
There are three pages in the program editing page:
Program editing page I
Program editing page II Program editing page III
Push the ‘Back’ or ‘Next page’ buttons to shift pages. The page I and II are parameter setting
page while the page III is alarm parameter setting.
Click the edit box to enter parameter end by pushing the ‘ENT’ button. After editing the parame‐
ters, push the ‘Back’ button to go back to the previous page.
If you need to restore the factory setting, please push the ‘Default’ button.
The parameters in I, II and III must be modified correspondingly. For instance, once the
diffusion time is modified in I, the parameters of diffusion overtime in III should be modified cor‐
respondingly, otherwise, the unacceptable alarm result will occur.
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There is no need to adjust normally. If necessary, please adjust them as follows:
a. Normally, the controller shows the setting value (SV) and actual value (PV) of temperature:
b. Push the ︽ or ︾ button to adjust the SV value as 50℃:
c. If change a new temperature controller, please adjust as follows: push and hold the but‐
ton for 3 seconds to enter into the following page. Push ︽ or ︾ button to set the SV value as
1(set the input type of temperature sensor):
d. Push the button to set the following page (select the temperature unit as ℃):
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e. Push the button to set the following page (set the upper limit value):
f. Push the button to set the following page (set the lower limit value):
g. Push the button to set the following page:
h. Push the button to set the following page (select standard control):
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i. Push the button to set the following page (set ST adjustment):
j. Push the button to set the following page (control period‐‐‐second):
k. Push the button to set the Alarm 1 as 1 (the alarm type is 1):
l. Push the button to set the Alarm 2 as 2. You do not have to set alarm 2 since it is use‐
less for this equipment.
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m. Push and hold the button to exit setting.
n. Push the ︽ or ︾ button to adjust the SV value as 50℃:
o. Push the button to set the following page (start the equipment):
p. Push the ︽ or ︾ button to set the upper limit value for Alarm 1 as 5. The alarm will sound
once the temperature exceeds the setting value by 5℃.
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q. Push the ︽ or ︾ button to set the lower limit value for Alarm 1 as 15. The alarm will sound
once the temperature exceeds the setting value by 15℃.
r. Push the button to exit.
s. Push the button and twice push the button to set the hysterisis heating value as 0.5:
t. Push the button to exit. All settings are done.
3.2. Setting of plasma power source
Plasma power source XH‐SP‐1
For the preliminary debugging, turn the power rate knob to the minimum. Make sure the low‐
pressure switch (green) and the high‐pressure switch (red) are turned on. Wait till the power
source starts working, gently adjust the power rate knob and make the current value in between
1.3A and 1.5A.
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Vacuum pump structure
Layout of cleaning components
4.2. Oil filter
The filter element should be replaced in every 300 running times.
The filter element could be replaced earlier if it is damaged or there is strong oil smell in
room.
4.3. H2O2 filter
The filter element should be replaced in every 500 running times.
The filter element could be replaced earlier if there is strong oil smell in room.
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5. Fault alarm and solutions
Messages Reasons Solutions
Check whether the detection of the tempera‐
The chamber tem‐ ture sensor is normal.
perature is higher Check whether the output point Q2.1 of the
than set value. PLC works well.
Check whether the solid‐state relay is normal.
If the equipment is just turned on, please
The tank tempera‐ wait for 50mins since the sterilizer is not to‐
ture T1 is wrong! tally preheated.
The chamber tem‐ Check whether the output point Q2.1 of the
perature is lower PLC and the solid‐state relay work well.
than set value. Check whether the detection of the temper‐
ature sensor is normal.
Check whether the heating element and its
wiring connection are normal.
Check whether there is output from Q2.3
The door tempera‐
(front door) and Q4.2 (back door) of the PLC.
ture is higher than
Check whether the relay J16 (front door) and
set value.
J19 (back door) are normal.
If the equipment is just turned on, please
wait for 50mins since the sterilizer is not to‐
tally preheated.
The door tempera‐ If the equipment is turned on for more than
ture T2 is wrong! 50mins, check whether there is output from
The chamber door
Q2.3 (front door) and Q4.2 (back door) and
temperature is lower
the relay J16 (front door) and J19 (back door)
than set value.
are normal.
Check whether the detection of the tempera‐
ture sensor is normal.
Check whether the heating element and its
wiring connection are normal.
The steam tem‐ The gasifier temper‐
perature T3 is The heating control relay of the gasifier can‐
ature is higher than
not be disconnected.
wrong! set value.
The steam tem‐ Check whether the detection of the tempera‐
The gasifier temper‐
perature T3 is ture sensor is normal.
ature is lower than
Check whether the heating element and its
wrong! set value.
wiring connection are normal.
Check whether the heating element and its
The purifier is too The purifier temper‐
wiring connection are normal.
ature is lower than
cool! Check whether the detection of the tempera‐
set value.
ture sensor is normal.
The heating control relay of the heating ele‐
The purifier is too The purifier temper‐
ment is broken.
ature is higher than
heat! The purification fan is faulted.
set value.
Check whether the detection of the tempera‐
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The door is open‐ Close the door.
The door is not fully
The travel switch of the door‐close position is
ing! closed.
faulted.
The pump over‐ Vacuum pump con‐ Check the operating conditions of the electri‐
heating tactor overheating cal appliances in the control part of vacuum
protection! protection pump.
6. Parts failure and solutions
6.1. Screen
Failure Solutions
The screen cannot be
Check whether the DC 24V power of the screen is well connected.
switched on.
The screen does not Check the communication wire.
work well. Check whether the PLC works normally.
6.2. Printer
Failure Solutions
The working indicator
Check whether the DC 24V power of the printer is well connected.
is not on.
Self‐checking method of SP2 printer: remove the printer power
plug push and hold the paper feeding button plug in the power
plug release the paper feeding button.
The printer does not Check (in the page of alarm view) whether the printing type match‐
work. es the sterilizer printing type. Please select PLC printing if the steri‐
lizer has no gateway, otherwise, please select gateway printing.
Check whether the red indicator of the gateway storage (if any)
keeps flashing. If not, that means there is communication error in
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gateway and PLC.
6.3. Electric actuator and door component
Working principle of electric actuator:
1) AC transformer converts 220V AC into 24V AC;
2) Rectifier bridge converts 24V AC into 24V DC;
3) 24V DC flows to relay J3 and J4 via door motor protective panel to control the door motor.
Failure Solutions
Check whether there is other load on door motor.
Check whether there is output from PLC.
Check whether the relay works normally.
The door does not
Measure the voltage that rectified by the rectifier bridge.
move.
Measure the voltage of the door motor.
Remove and check the door motor.
Check the up&down door travel switch.
6.4. Cassette system
Failure Solutions
Check whether the travel switches on both ends of the feed stepper
motor work well.
Check whether the voltage between driver +V and GND is DC24V.
Check the wiring of driver PUL:
PUL1‐‐‐‐JX1‐36‐‐‐‐R1‐1‐‐‐‐Q0.0
The feed stepper motor
Check the direction control line of driver DIR:
does not act.
DIR1‐‐‐‐JX1‐37‐‐‐‐R3‐1‐‐‐‐Q3.4
Check the wiring of driver OPTO.
Check the wiring of the stepper motor and driver:
(A+)‐‐‐red (A‐)‐‐‐red white
(B+)‐‐‐green (B‐)‐‐‐green white
Check whether the travel switches on both ends of the puncture
stepper motor work well.
Check whether the voltage between driver +V and GND is DC24V.
Check the wiring of driver PUL:
PUL1‐‐‐‐JX1‐38‐‐‐‐R2‐1‐‐‐‐Q0.1
The puncture stepper
Check the direction control line of driver DIR:
motor does not act.
DIR1‐‐‐‐JX1‐39‐‐‐‐R4‐1‐‐‐‐Q3.5
Check the wiring of driver OPTO.
Check the wiring of the stepper motor and driver:
(A+)‐‐‐red (A‐)‐‐‐red white
(B+)‐‐‐green (B‐)‐‐‐green white
Poor sealing.
The valve is blocked or not opened up.
Checking method: a blocked or closed V2 may cause a low pressure dur‐
Injection valve V2 fault
ing the diffusion cycle. In the beginning of the purification cycle, observe
whether there is no liquid flow through V2 after a capsule puncture. If so,
that means the V2 is blocked or not opened up.
Check whether the feed motor and puncture motor are working
normal.
Check whether the zero position of cassette feeding device is correct.
If not, please adjust the micro‐switch feeler lever of the zero position.
The capsule has not
Check whether the cassette fixing device is horizontal. If not, please
been punctured.
loosen the screws and adjust the fixing device to make it horizontal.
Check whether the puncture needle is bended. If so, please replace
it.
Check whether the puncture needle height is fitted. If not, please
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Failure Solutions
adjust the height of the needle panel.
Check whether the distance between the detecting switch and cas‐
sette is within 1.5mm. If not, please adjust the cassette fixing device to
The cassette cannot be
make it slightly lean forward.
detected.
Check whether the wiring of the detecting switch is normal. Check
whether it is damaged.
6.5. H2O2 purification system
Failure Solutions
The purifier temperature Check whether the purifier fan is normal.
is over high. Check whether the temperature detection is normal.
The purifier temperature Check whether the purifier PTC heating is normal.
is over low. Check whether the temperature detection is normal.
The gasifier temperature Check whether the temperature detection is normal.
does not meet the cer‐ Check whether the heating element and its wiring connection are
tain value. normal.
Diffusion valve V6 fault or not turned on.
Checking method: go to the manual operation interface turn on
the vacuum pump, valve V3 and V6 if the purifier pressure P1 does
not decrease after 2~3mins that means the valve V6 is not turned on.
H2O2 diffusion pressure is The H2O2 inlet port is blocked.
low. Poor sealing of purification valve V5 or diffusion valve V6.
Checking method: go to the manual operation interface turn on the
vacuum pump, valve V3, V5 and V6 vacuum the chamber pressure to
2000Pa turn off V5 and V6 if the purifier pressure P1 keeps de‐
creasing that means the valve V5 and V6 are not well sealed.
6.6. Vacuum and vacuum‐breaking system
Failure Solutions
Check the phase sequence relay. It should be NORMAL and the
green light is on.
Commutate any 2 phase fire wire of main power if the green light is
The vacuum pump does
not on.
not work.
Check whether there is output from PLC (Q0.5).
Check whether the control relay (J2) is closed.
Check whether the contactor is closed.
Check the pump oil and change it on time.
Check and clean the pump inlet filter.
Check the pump outlet filter. Please change if it is blocked.
Check the vacuum baffle valve.
Checking method:
a) Remove the bellows which connected with the baffle valve go to
The vacuum pump
manual control interface turn on the valve V3 observe the valve
shows a poorer perfor‐
spool if the height that the valve spool has risen is less than 5mm
mance.
that means the baffle valve is not totally opened. Now you can remove
the top lid of valve V3 and tighten the screw inside. If it still does not
work, please replace it.
b) Take apart the valve V3 and check whether the bellows is damaged. If
so, please replace it.
5) Check the accuracy of the pressure transmitter P.
Check the air filter
Low speed of vacuum‐
Checking method: Remove the air filter. If the vacuum‐breaking is
breaking
normal means the air filter is blocked.
Poor sealing of valve V3. Remove the bellows which connected with valve V3. Check wheth‐
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er the O‐shape ring is detached or distorted.
Turn off the valve V3 when the chamber pressure reaches to a cer‐
tain negative pressure. If the pressure keeps decreasing means the valve
V3 is not well sealed.
If there is a poor sealing in V3, please take V3 apart and re‐fix the
O‐shape ring. If problem still happens, please replace.
6.7. Control elements of electrical cabinet
Failure Solutions
There is no output from Disconnect the master control switch for 5mins and re‐connect it.
DC12V switch power. Re‐check whether there is output from DC12V.
Gateway storage. The red light of the gateway storage should keep flashing. If
not, that means there is communication failure between the gate‐
way and PLC.
The USB disk must be formatted in FAT32 before being inserted
into gateway.
6.8. Temperature controller
Failure Solutions
The screen cannot be
Check the 220V power of WKX‐9 and WKX‐10.
switched on.
There should be output from temperature controller.
Check the DC12V output.
The temperature cannot
Check whether the relay is closed.
reach the certain value.
Check electro‐thermal film.
Check the temperature sensor.
The temperature exceeds
Temperature controller fault.
the certain value.
7. FQA
1) Q: How can I determine whether this instrument could be processed by the sterilizer?
A: Please refer to the sterilization rage mentioned in the operation manual. You can also inquire
the instrument manufacturer about the usage range.
2) Q: Why does the sterilizing indicator show that the sterilization is not qualified?
A: The indicators that will be used for plasma sterilization are: chemical indicating label, chemical
indicating card, paper‐plastic packing bag and self‐contained biological indicator. If any unquali‐
fied sterilization arises, please check the printed operation report to ensure that every parame‐
ter is normal. If the parameters are normal and at least two of the above indicators have proved
the sterilization is qualified, please check whether the unqualified indicator has been properly
used. You can also contact us for more questions.
3) Q: Is that normal if there is strange smell in the room?
A: It is normal. That is the smell of H2O2. Since the sterilizer equipped with H2O2 filter, there will
be minute quantity of H2O2 released out. We suggest that the basic ventilation facility should be
installed in room.
4) Q: Is that normal if there is smell of oil or smoke?
A: The sterilizer equipped with oil filter that used for filtering the lampblack. Please check or re‐
place the filter if the smell is serious.
5) Q: Can we stack up the packed container to sterilize?
A: Yes, you can. But we recommend not to.
6) Q: Do EO and plasma sterilizations use the same paper‐plastic packing bag?
A: No. Please does not use EO packing bag for plasma sterilization and vice versa.
7) Q: Do we have to pack the items before plasma sterilization?
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A: In order to protect the chamber inner wall from scratching or other injury and avoid the sec‐
ond contamination on the sterilized items, the items have to be packed by paper‐plastic bag or
double‐layer nonwoven fabrics.
8) Q: What is the expiring period of the items after plasma sterilization?
A: 6 months.
9) Q: Can plasma bio‐indicator be replaced by other indicator?
A: No, it cannot be replaced by any other indicator.
10) Q: What is the incubating temperature of plasma bio‐indicator?
A: 56℃.
11) Q: What is the leakage rate of APS‐1X? How can I test?
A: In the pressure‐holding status (with no load) go to the system maintenance interface
orderly turn on PUMP, V6 and V3 to vacuum to 65Pa orderly turn off V3, PUMP and V6 to car‐
ry out pressure‐holding. The acceptable leakage quantity is no more than 100Pa within 10mins.
You can operate the pressure‐holding cycle to view the pressure‐holding information.
12) Q: What is the injection quantity of H2O2 for APS‐1X?
A: Full cycle: 2 capsules; 2.2ml H2O2 per capsule.
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8. Electric drawings
8.1. Layout diagram of electric box main board
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8.2. Wiring diagram of electric box
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8.3. Transformation, rectification and power‐on schematic
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8.4. Electrical circuit sketch
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8.5. Wiring diagram of pump startup box
Manufacturer
ARI Medical
Technology Co., Ltd.
Add: Block
A, Lotus Industrial Park, Economic Development Zone, Hefei City, Anhui, China.
Tel: 0086-551-63802963
Fax: 0086-551-63802920