OPERATING and MAINTENANCE MANUAL

Horizontal Autoclave LD-LHA-I14

Labodam Equipment Ltd., UK

www.labodam.com | info@labodam.com

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 Contents

Prologue .................................................................................................................................................................. 4
Chapter 1. Basic introduction ...................................................................................................................... 5
1.1 Basic introduction ............................................................................................................................... 5
1.2 Requirements on environmental conditions ............................................................................ 5
1.3 Technical advantage ........................................................................................................................... 5
1.4 Safety device .......................................................................................................................................... 6
Chapter 2. Technology parameters .......................................................................................................... 8
Chapter 3. Installation ................................................................................................................................. 9
3.1 Requirements positioning and environment............................................................................ 9
3.2 Water quality for pure water tank ................................................................................................ 9
3.3 Installation of circuit .......................................................................................................................... 9
3.4 Unpacking check .................................................................................................................................. 9
3.5 Installation .......................................................................................................................................... 10
3.6 Connection .......................................................................................................................................... 10
3.7 Debugging ............................................................................................................................................ 10
3.8 No-load test ......................................................................................................................................... 11
Chapter 4. Preparation before using ..................................................................................................... 12
Chapter 5. Operation instruction ............................................................................................................ 14
5.1. Sealing Door........................................................................................................................................ 14
5.2. Parameter setting ............................................................................................................................. 15
5.2.1. How to set parameters........................................................................................................... 16
5.3. Running ................................................................................................................................................ 16
5.3.1. Program running ...................................................................................................................... 17
5.3.2. Vacuum test (Leak detection) ............................................................................................. 18
5.4. Maintenance ....................................................................................................................................... 19
5.4.1. Basic parameter........................................................................................................................ 20
5.4.2. Printer set ................................................................................................................................... 20
5.4.3. Deviation correction ............................................................................................................... 22
5.5. Precautions ......................................................................................................................................... 22
Chapter 6. Maintenance ............................................................................................................................... 23

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 6.1. Daily maintenance............................................................................................................................ 23
6.1.1. Things should be done before duty off ............................................................................ 23
6.1.2. Daily maintenance on main parts ...................................................................................... 23
6.1.3. Maintenance on electrical components........................................................................... 24
6.1.4. Scale removal............................................................................................................................. 24
6.2. Daily operating procedures ..................................................................................................... 25
6.2.1. Prepare before using .............................................................................................................. 25
6.2.2. Sterilization operation ........................................................................................................... 26
6.2.3. Things should be done after using .................................................................................... 26
Chapter 7. Quality assurance measures .............................................................................................. 27
7.1. Items must be cleaned before sterilizing ................................................................................ 27
7.2. Vapor source quality ....................................................................................................................... 27
7.3. Environment of sterilizing room ................................................................................................ 27
7.4. Packaged and placed ....................................................................................................................... 28
Chapter 8. Sterilization effect detection.............................................................................................. 29
8.1. Chemical detection ........................................................................................................................... 29
8.2. Biological detection ......................................................................................................................... 29
8.3. B-D test ................................................................................................................................................. 30
Chapter 9. General Maintenance and Urgency................................................................................. 31
9.1. Rise and carry .................................................................................................................................... 31
9.2. Faults Analyze .................................................................................................................................... 31
9.3. How to take down the cover: ....................................................................................................... 32
9.4. How to check safety valve: ............................................................................................................ 32
9.5. How to change safety valve .......................................................................................................... 32
9.6. How to change heater ..................................................................................................................... 33
9.7. How to clean the magnetic valve: ............................................................................................... 33
9.8. How to clean the water inlet filter ............................................................................................. 34
9.9. How to clean the drain water filter valve. ............................................................................... 34
9.10. Door safety interlock device .................................................................................................... 34
9.11. Pipeline description in the back of the sterilizer ............................................................. 35

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 Prologue

1. Usage of operation and maintenance manual

Operation and maintenance manual is a part of the sterilizer, providing the necessary
following data:

1) Overview for the instrument.

2) How to assemble the machine correctly.

3) How to operate the machine correctly.

4) Daily maintenance of the machine and other attentions.

5) Cautions about the safety matters.

2. Preservation of operation and maintenance manual

It must be preserved well and follow the sterilizer.

3. Attention things
The sterilizer must be operated according to the procedures, which introduced in the
manual. If there were aborts, please read the aborts-analysis form and try to solve it yourself.
If you cannot, please contact us as soon as possible. We appreciated if the customers provide
the detailed depiction of the aborts and the medal of the details would be changed.

4. Instruction of safety sign

!!! Warning：

Caution operators the possible injury to human and damage to machine.

!! Be care：

Caution operators the possible light injury to human and damage to machine.

! Attention：

Caution to customers it is possible to operate unsuccessfully and sterilize incompletely.

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 Chapter 1. Basic introduction

1.1 Basic introduction

This equipment is the ideal equipment for treatment to medical instruments, dressing
packages, glass utensils and etc. in ophthalmic department, stomatology department, and
operating room, laboratory and biology medical research department with its easy
operation, convenient application and nice looking.

➢ The main shell is made of stainless steel, and the inner surface is treated by
mechanical polishing and electro polishing, which is not only beautiful but also
greatly enhanced corrosion resistance.

➢ The door plank material inside is made of AISI304, the outside door plank is made of
AISI304 stiffener, and an insulation material coating is used to minimize heat
radiation.

➢ It is controlled by a PLC with powerful functions, high reliability, and flexibility.

➢ It is easy to communicate between the operator and machine; a 4.3-inch color touch
screen is adopted, which can dynamically show and print all kinds of parameters such
as temperature, pressure, and time during the sterilization cycle with a direct visual
effect.

➢ The model of pulse sterilizer heat quickly adopts a steam generator to provide steam.

➢ Exhaust the air in the chamber completely by pulse three times, be sure the sterilizing
medium is saturation steam, and realize efficient sterilization in a short time.

1.2 Requirements on environmental conditions

It should be placed in a clean, dry, shady room with ventilation and low temperature
difference.

1) Room temperature 5℃ - 40℃.

2) The highest relative humidity: 85%.

3) The allowed range of voltage vibration: ±10%.

1.3 Technical advantage

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▪ High performance special controller based on embedded microprocessor is used by the
system control, function is power and process control is accurate.

▪ Touch screen display, with beautiful and clear picture, easy to operate.

▪ Visual isolated pure water tank and circulating water tank system which avoid distilled
water disadvantage occurs during water-cycle, easy to clean and avoid heat generated.

▪ Advanced fuzzy control heating technology is used, with heating up quickly,

temperature-control accurate and energy-saving effectively.

▪ International leading automatic switch structure adopted ensures personal safety and
labor intensity reduced.

▪ Independent quick steam generator is adopted, and the whole process finishes within
30mins.

▪ The pot wall silica gel heating membrane used can arrive at preheating temperature
quickly and make sure of the good effect of drying.

▪ Equipped with built-in steam-water separator can effectively avoid wet pack, reinforce
drying effect and prolong service life of vacuum pump.

▪ Built-in vacuum pump with high quality is imported, pulse vacuum 1-6 times and vacuum
degree can arrives at -0.09 Mpa (-0.9Bar), to ensure effective removal of the air inside
dressing, sterilizing bag and dental hand-piece so as to get the optimum steam saturated
state.

▪ Perfect maintenance information indicating function.

▪ Cycle countdown function.

▪ Perfect fault check system, the fault information is shown on touch screen display.

▪ The beep will sound once the sterilization cycle completes.

1.4 Safety device

The sterilizer equips following safety devices:

➢ Over-temperature protection: mechanical and electronic double over-temperature

protective device adopted will cut off heater power supply once over-temperature
occurs.

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➢ Over-pressure protection: double over-pressure protective device can release pressure
quickly to ensure personal and equipment safety once the pressure exceeds desired
value.

➢ Circuit safety protection: direct current control loop is equipped with over-pressure and
overload protector, exchange current main loop is equipped with short circuit and
leakage protector.

➢ Safety interlock door: electric lock adopted to ensure the sterilizer can begin to work only
if the door is closed properly. The door can’t be opened when pressure is in chamber or
the power supply is not connected.

➢ Motor door overload protection: the system will automatically reminder user to close the
door manually.

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 Chapter 2. Technology parameters

Technical Parameter Value

Capacity 180L
Design pressure 0.3 Mpa
Design temperature 150 ℃ Max. working pressure: 0.23 Mpa
Sterilization temperature range 105℃～138℃
Pulsation times 1～6 times
Sterilization time range 0～9999 seconds
Drying time range 0～9999 seconds
Safety valve 0.25 Mpa
Pulse amplitude Upper limit positive 10KPa～99KPa，lower limit
negative 10KPa ～99KPa
Temperature accuracy 0.1℃
Temperature homogeneity ≤±0.5℃
Chamber material AISI304 stainless steel
Water requirement Soften or pure water is used for pure water, tap water
or soften water is used for circulating water tank.

Attention: if water quality in local is hard, please add soft water to circulating water
tank.

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 Chapter 3. Installation

3.1 Requirements positioning and environment

This sterilizer should be placed on a steady, clean and horizontal place. You can lift the front
feet with about 5cm.

Meanwhile the two sides and the back of the sterilizer should be kept at least 25 cm from
other objects for the purpose of ventilation.

!!Caution：

The covers of water tank should be closed.

3.2 Water quality for pure water tank

Only use pure or soften water.

➢ Electric character：≤15μS/cm

➢ Deodorant content：≤2mg/l

➢ PH value：5-7

➢ Rigidity：≤0.02mol/l

➢ Please check the water position in tank before every day operation.

3.3 Installation of circuit

Choose the wire and socket according to the power of the equipment. Local rules and
regulations on installation and safety should be abided.

!!!Notice: The power supply must be connected to the ground.

3.4 Unpacking check

Please check packing box whether is damaged or not before unpacking.

Please check all components whether is damaged or lost carefully. If any question, please
contact us immediately.

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Please check that junction parts or fixed parts whether are loose carefully after a long-
distance transport, if happens, thus tightens it.

Please check accessories or spare parts whether are complete refer to packing list after
unpacking. If any problem, contact us immediately.

3.5 Installation
Only trained, experienced staff can install the device under the guidance of professional.

❖ Space: Both right and left sides of the device should keep no less than 0.5 meters away
from walls.

❖ Ground: Ground should be smooth.

❖ Ventilation: Suggests that ventilation device should be installed in work space in

order to control temperature, decrease noise and heat quantity effecting on
environment.

❖ Drainage: Drainage pipe need be lead to trench alone. Wide trench need be at least
200mm, depth need 200mm.

3.6 Connection
(1) Move the equipment to the suitable place.

(2) One side of water pipe connects external purified water tank, the other side connects
the joint in the bottom of equipment.

(3) Adjust horizontal

The equipment is placed on horizontal ground directly. The front of equipment should be
higher than its back.

(4) Power supply is set according to specific setting location and requirement.

3.7 Debugging
(1) The sterilizer contains pre-set procedures so user can modify program parameters
according to requirements during debugging.

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 (2) Prior to debugging, please check such as electrical wiring, sockets whether drop out,
loose, check that water intake, drainage, steam and compressed air connection
whether are correct.

(3) Check whether the amount of purified water in the external tank is sufficient. Check
to see if the water level in the circulating water tank has reached its lowest point.

3.8 No-load test

Vacuum test should be done according to Chapter 5 <Operating instruction> before
program operation. If fails, indicate that the pipeline connected with inner chamber leaks.
Please check carefully, eliminate leakage point, retest until successful, otherwise it will have
an effect on sterilization.

Parameters set: Refer to Chapter 5 <Operating instruction> to preset basic parameters

and working parameters for each program.

Fabric, instrument, 121℃, B-D test program can be no-load normally after parameters set.

Detail operations refer to Chapter 5 <Operating instruction>.

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 Chapter 4 . Preparation before using

4.1. Preparation work

The being sterilized articles must be washed before being put into the sterilizer in order to
avoid the resting things on the articles damaging the sterilizer and themselves. For example,
blood and other impurities.

At the same time we make idiographic references:

1) The rested things on the instruments that need be sterilized should be washed firstly.

2) We suggest purified liquid and distilled water to wash the instruments.

3) Go on washing after the instruments are washed in order to keep them clean.

4) Put different instruments, like stainless steel, carbon steel, and so on, in different
trays and make proper clearance among them.

!!! NOTICE:

1) If the instrument made of carbon steel is put in a stainless steel tray, disinfected or
CEB papers should be put on the tray first, with the purpose of avoiding them directly
connecting with each other.

2) Put a direction card on each tray.

3) In order to test the sterilization effect, put the biological spore indicator into the
articles once a week.

4) Ensure that the tools remain apart throughout the sterilizing procedure.

5) If the tray is overfilled, it could affect how the drying and sterilizing processes work.

6) The instrument should be packed with materials that breathe freely, such as
sterilized bags, papers, and chiffon fabrics.

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 4.2. Preparation of rubber pipe sterilized
First use warm water to wash it, then put it on clean tray, make sure both ports of the pipe
are opened with no corner, distortion or twist.

4.3. Preparation of dressing bags sterilized

Put the dressing bags upright on the tray and avoid touching with the wall.

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 Chapter 5. Operation instruction

Warning: Don’t touch control panel at will, ensure screen surface clarity!

5.1. Sealing Door

➢ Open control power supply, operation power supply.

Figure 1 will be shown after the touch screen connects with electricity through self-checking
for a certain time. Press the picture or enter it into the main menu automatically, which
shows temperature and pressure inside the chamber, pressure in the generator, the current
clock, and so on. Enter into each sub-menu for follow-up operations through the main menu.

Figure 1

➢ In this picture, click blank place, then the system enters into the main menu as Figure
2 shown automatically.

Temperature and pressure in chamber are shown on the top left of picture.

Temp: temperature in chamber

Pres: pressure in chamber

Three operation button including “Program”, “Running”, “Maintenance” appear closely

following.

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 Figure 2

➢ Door operation

Don’t open the door by hand until pressure in chamber is close to local pressure (Pres:
0.0KPa)

5.2. Parameter setting

Press “Program” button on main menu to program parameter setting picture, five sets of
sterilization programs and two sets of detection programs are set by this control system.

a) Sterilization programs:
1. Unwrapped: unwrapped instrument program

2. Wrapped1: instrument wrapped program 0

3. Wrapped2: dressing wrapped program

4. Rubber: rubber program

5. Self-defined: user-defined program

b) Detection programs:

1. B&D test program,

2. Vacuum test program

Take unwrapped instrument as an example to introduce how to set parameters.

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 5.2.1. How to set parameters

Figure 3

To get perfect sterilization effect, various default parameters are set. Meanwhile, the above
values can be adjusted according to requirement, and parameter set should ensure
sterilization effect. Drying time can be prolonged properly if higher demand for drying effect.

Press “BACK” button to “Main menu” picture (See Figure 2) after parameters set finishes.

5.3. Running
Press “Running” button, system enters into program running selection picture.

Figure 4

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Select suitable program based on goods to be sterilized from “Select” button.

5.3.1. Program running

Take unwrapped instrument as an example, press “Unwrapped” to running workflow
picture, as Figure 5 shown: diagrammatic sketch of pipe line is clear to observe and elements
working state, display the whole sterilization cycle.

For example, at pulse phase, pulse indicator is on flicker, corresponding valve and pump
work properly.

Figure 5

Introduce the whole workflow:

(1) Pulse stage: During this stage, air in chamber is exhausted, chamber is heated and cold
air is eliminated for many times.

Workflow: Firstly, water from the pure water tank runs into the chamber when the
vacuum value arrives at the pulse-down limit value. Secondly, heating starts in the
chamber until the steam value in the chamber reaches the pulse upper limit value, then
steam is exhausted to the pure water tank. So I repeated it several times, aiming to
eliminate the cold air inside the chamber.

(2) Heat stage: After pulse stage, purified water from pure water tank enters into chamber,
heating pipe begins to work and temperature rises in chamber reaching to sterilization
value.

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(3) Ster stage: Items to be sterilized during this stage, meanwhile, temperature will be hold
at setting sterilization temperature range.

(4) Release stage: Pressure in chamber relieves at this stage. Then, drying period starts.

(5) Dry stage: The temperature in chamber is hold through temperature in jacket, at the
same time, drying goes on by vacuum-pumping.

(6) End stage: At this stage, pressure in chamber is close to local pressure, buzzer sounds,
and message “Open door” shown indicates the whole process is over.

After that, the whole workflow finishes. Fetch sterilized items by opening the door.

During sterilization operation, if you want to cancel this action, press “Stop” button to stop
halfway, this sterilization fails.

If cancel the procedure when water from pure water tank injects into chamber, please open
chamber door and stay far away from the door to avoid scalding.

Saturated water vapor pressure (Kg/cm²) and corresponding temperature (℃)

Pressure 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6
Temperature 116.9 118.5 120.1 121.6 123.1 124.5 125.9 127.2 128.5
Pressure 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.4 2.5
Temperature 129.7 130.9 132.1 133.3 134.4 135.4 136.5 137.5 138.5

5.3.2. Vacuum test (Leak detection)

In the process of debugging or routine testing of equipment, especially after a long-distance
transport, pipeline maybe loose or BD test fails. At this situation, you can choose vacuum test
which is mainly used to test vacuum leak so as to detect the sealing state of pipeline.

This test goes on in case of non-load in chamber. Press “Vacuum” button on operation
picture as Figure 6 shown.

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 Figure 6

Vacuum test workflow: Firstly, vacuum test setting value reaches after vacuum-pumping
(Usually -80KPa set), then close all output to test pressure which lasts for 15mins. After that,
program begins to compare initial pressure value with ended pressure value, and count
vacuum leak rate which less than 0.13KPa/min is successful.

After the vacuum test, the message shown indicates opening the door. Press it, and the
program enters the “Main Menu” picture. (See Figure 2)

5.4. Maintenance

Figure 7

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 5.4.1. Basic parameter
Press “Maintenance” button on main menu, enter into picture shown as Figure 7, modify
and set parameters by yourself.

Confirm the parameter setting value, touch corresponding value frame, then value keyboard
shows up and input the setting value you want.

Note: System parameters have been set before leaving factory. Please modify
it by professional if needed.

[Pulse times]–Vacuum-pumping times. (3 times generally)

[Pulse up]– Pulse up-limitation indicates the maximum setting point of pressure in the
chamber in the process of a pulse.

[Pulse down]– Pulse down-limitation indicates the minimum setting point of pressure in the
chamber in the process of a pulse.

[Empty up]– The maximum pressure value is for door safety operations. Generally, 10 kPa
sets. If it is higher than 10 kPa, the door lock is on.

[Empty down]–Minimum pressure value is for door safety operation. Generally -10KPa set.
If it is lower than -10KPa, door lock is on.

[Local pre]–Local pressure.

[Vacuum test]–Indicate the setting depth of vacuum-pumping during vacuum test.

5.4.2. Printer set

In this picture, you can set switch system print, date and time display for printer.

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 Figure 8

Press “Time set” button, enter into time set picture, then Press “OK” button after setting.

Figure 9

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 5.4.3. Deviation correction

Figure 10

Press the “Deviation” icon to adjust value when temperature and pressure on touch screen
are not in accord with actual value.

Pressure deviation in chamber: Pressure detection correction in chamber. (Modified by

experienced technicians only)

Temperature deviation in chamber: Temperature detection correction in chamber.

(Modified by experienced technicians only)

5.5. Precautions
➢ Don’t touch indicator button of printer in case that it interrupts communication and
process stops during operation.

➢ Don’t press the selective button frequently if the touch screen does not respond.

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 Chapter 6. Maintenance

Well maintenance can guarantee the sterilizer is in a good working state and has a long time
of use. So take care of the maintenance. Make sure the maintenance work is done without
using power or pressure.

6.1. Daily maintenance

6.1.1. Things should be done before duty off
Everyday

• Rub-up the airproof loop with a soft cloth or gauze.

Every week

• Clean the cover with a soft cloth.

• Clean the inner wall, shelves, trays with gauze which has cleanness liquid and water.
Do not use steel brush in order to avoid damaging the inner wall.
• Clean and get rid of furring.
• Check on time:
• Check safety valve once a month.
• Tighten the tie-in and check communication state by professional electrician once a
year.

6.1.2. Daily maintenance on main parts

Vacuum pump: Water ring seal is used to vacuum-pumping.

Water rings have an effect on sealing and energy conversion. A large amount of water is lost
with steam exhaust, so water needs to be supplied constantly in the course of its work.
However, the water quantity should not be too large; if so, it will increase the pump power
loss and have an adverse impact on the working environment.

Water quantity should be adjusted through cut-off valve of water inlet pipe according to
practical situation.

Water quantity and water temperature affect vacuum rate and service life of pump directly.

Maximum temperature is lower than 25℃ as generally requirement.

Screw plug should be opened to drain out in pump, and then blocked drainage holes, filled
with saponification liquors when long-time shutdown. Otherwise, it is easy to produce
corrosion or cracking of the pump, which effect efficiency and service life of pump.

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Safety valve: It is designed to protect equipment and operator safety. Opening pressure and
return pressure have been adjusted before leaving factory, so it’s better for user not to
modify at will so as not to accident occurs.

Handle need be pulled several times at intervals of half a year, wash with steam in order to
prevent its parts from corrosion after a long-term inaction which results in overpressure
valve doesn’t work properly.

Note: Don’t touch valve handle by hand directly.

Pull by Screwdriver or strips of cloth so as not to harm to operator by steam!

Non-return valve: Non-return valve is installed both on exhausting pipe of door and water
inlet inside chamber and is inspected regularly to ensure its sealing performance. The most
simple way carry out nozzle suction test after cleaned, no leakage is normal.

Solenoid valve: In order to ensure solenoid valve work properly, solenoid valve spool,
valve seat must be cleaned every quarter to prevent impurities affect the pipeline open and
close

6.1.3. Maintenance on electrical components

• Electrical components and line are forbid to contact water. If happens, power can’t
be connected unless being handled.
• Dust must be cleaned every quarter.
• Check socket, interconnecting devices whether are loose, plug it tight if loose.

6.1.4. Scale removal

As the water is too hard in some areas, plenty of scales will be deposited in pump and
pipelines after the long-term operation of equipment, which affects the normal operation of
equipment.
Suggest that standard boiler water or deionized water should be used, and various chemical
detergents are used to clean scales regularly (usually every six months).
Scale removal process:

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 (1) Firstly, let water in vacuum pump and circulating water tank go.

(2) Here is one three way on outlet, remove end cap of three way, Pour chemical
detergents into vacuum pump until vacuum pump, condenser and piping connected
with the chamber are full, waiting for 4 hours.(Other types of cleaning agents should
be the done followed by instructions).

(3) Take JT-100 water system security detergents as an example: blend cleaning agent
and water by ratio of 1:10 (as with other types of cleaning agents, they should be
followed by instructions), then open the vacuum pump to let water run into the
sewer. Finally, wash pump again and again until residuals all are removed.

Note: Avoid cleaning agents touching human body during the cleaning.

6.2. Daily operating procedures

6.2.1. Prepare before using

(1) Check purified water in external tank whether is enough to meet requirement.
Check water in Circulating water tank whether is over high level guard line. It’s
better for water level to keep on the bottom of water level, which can prolong
service life of Circulating water pump and ensure vacuum effect.
(2) Shut off power supply and control supply, press power switch, prepare for program
to operate.
(3) Mark operator’s name and test date on BD indicator paper, and then put it into
sterilizer to run BD test so as to detect equipment whether is leaked and normal.
(4) Strapping not too tight, chemical indicator tape is put outside, chemical indicator is
put inside when arranging package to be sterilized.
(5) Check whether sundries or damage is in seal ring and front closing plate, scrub with
a clean cotton cloth.

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6.2.2. Sterilization operation

(1) Open the sealing door, place sterilized items packaged into chamber after B-D test is
successful. There are gaps between packages and packages, don’t lean close to the
chamber wall and door panel).

(2) Close sealing door, select sterilization procedures according to items to be sterilized,
check parameters whether are correct, start program.

(3) Operator shall observe operational status closely without being away from the
equipment, if abnormal, handle the accidents timely.

(4) Detect sterilization effect, store record in order to follow-up check.

(5) Don’t fetch items from chamber until pressure in chamber backs to zero after
sterilization.

(6) Sterilized items removed from chamber should be placed on shelf in order to prevent
secondary pollution.

6.2.3. Things should be done after using

(1) Open the front door, shut off power switch, cut off control power, power supply and
air compressor power.

(2) Inside and outside of sterilizer and operation room should be kept cleaned after daily
work finishes.

Pure water tank should be cleaned every week and water in Circulating water tank should
be replaced once two weeks.

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 Chapter 7. Quality assurance measures

To get reliable sterilization effect, besides equipment designed, quality produced as well as
perfect maintenance, it’s also related to some human factors such as operator’s basic
knowledge of sterilization, working principle mastered, and operating standard carried out
strictly.

Note: Special attention to avoid being scalded under high temperature situation.

7.1. Items must be cleaned before sterilizing

Sterilized items cleaned prior to sterilizing is the key factor to make sure sterilization
successful, especially for medical supplies which is difficult to be clean.

Pay attention to that it can’t reduce cleaning requirement through prolonging sterilization
time and raising sterilization temperature. It is better to use cleaning agent containing
enzyme to remove organics effectively.

Note: Can’t reach sterilization effect perfectly without correct cleaning.

7.2. Vapor source quality

(1) Saturated steam

(2) Steam drying: Saturated steam content can’t be lower than 97%.

(3) Water quality control: PH value range is 7～7.8, water should be softened.

7.3. Environment of sterilizing room

The ground should be smooth, waste water outlet leans slightly, keep operation space clean
and dry. Wall should be smooth, isolate from flush area and prepare working place.

The discharge outlet of waste steam and waste water must go through wall or be embedded
into trench, or be exhausted to air.

Ventilation device is installed on top of wall or ceiling properly.

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7.4. Packaged and placed

➢ Dressing fabric wrapped in the folded should be appropriate in order to ensure steam
penetration.

➢ Adjacent packages should be kept 10mm away from each other, and loading should
not exceed 80% capacity of chamber in order to ensure steam smooth.

➢ Items to be sterilized are placed by instruments with air vent.

➢ It is better to sterilize the similar items at the same time. If different types of sterilized
items must be placed together, the temperature and time of sterilization are required
based on the items hardest to be sterilized.

➢ Items packaged should not be too tight, paste if by chemical indicator tape, with
chemical indicator placed inside it.

➢ Metal ware such as plates, pots, and bowls should be placed upright. The direction of
fiber material should be perpendicular to the horizontal plane. Glass bottles, glass
tube should be put downward or on its side in order to inlet steam and exclude air.

➢ Metal items should be placed underneath dressing package when they are sterilized
together, so that both of them can get the same heat, and avoid condensate water
generated by metal items wet packages.

➢ Large packages hard to be sterilized should be placed on top, small packages easy to
be sterilized should be placed below.

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 Chapter 8. Sterilization effect detection

The detection for sterilization effect is used to judge the sterilization way whether is
reasonable and sterilization effect whether is reliable.

8.1. Chemical detection

Chemical indicator: there are three types of chemical indicator: 115℃, 121℃, 132℃ to
detect sterilization effect.

Put chemical indicator into sterilization package, after a sterilization cycle, fetch it and
compare with standard color. If the indicator color is darker than standard color indicating
sterilization successful, otherwise, it fails and need to be sterilized again. To make sure
sterilization accurate, chemical indicator should avoid contacting items whose surface is
easy to produce condensate water.

Chemical indicator tape: one side is coated with adhesive, another side is coated with
chemical indicator, which not only is used to distinguish "sterile" and " unsterile", but also is
used as a seal attached to the dressing wrapped package. After sterilization, initially judge
the sterilization whether is successful through indicator color changes.

8.2. Biological detection

Biological detection is the way to identify sterilizer whether is qualified by testing
microorganisms within sterilized items killed completely.

• Calibration indicator bacteria: “Bacillus stearothermophilus” which is hardest to

be killed and strongest heat-resisting is used as a sterilization indicator.

• Medium: Bromocresol purple medium peptone water medium is used.

• Detection methods: Put 3M product 132 ℃ (121 ℃) biological indicators into the
center of standard test package. Place the test package on the top of exhaust outlet in
chamber. Take test package out of chamber and put it into 3M product culture vessel
for 48 hours to observe the color change of medium. Detect negative control and
positive control.

• Results: All the colors of medium don’t change indicating sterilization successful,
otherwise, the color change from purple to yellow indicating sterilization failed.

• Handling: The items sterilized unsuccessfully can be sealed temporarily to find out
the reason of failure, and then be sterilized again. Examine production date, valid
date, of biological indicator carefully as well as whether its damages and polluted.

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 • Debugging: It should be debugged for three times successfully prior to being put into
use before normal service or after being overhauled.

• Record: The test results should be recorded including: test date, sterilizing number,
sterilizing temperature, sterilizing time, indicator source, lot number valid date,
incubation temperature, incubation time, test results and examiner.

Film by bacteria after sterilization should be promptly removed according to the

manufacturer's instructions for dealing with bacterial culture.

8.3. B-D test

BD test is specially designed to test exhaust effect of air for vacuum pressure steam sterilizer.
• B-D test: It should be done at the first sterilization of every day.
B-D test chart should be placed in the middle of test package (disposable B-D test package
also can be used) ，and then put it on exhaust outlet in chamber. Shut off sealing door,
set parameters according to instructions, run a sterilization cycle. Open door, unpack test
package, fetch test chart and observe result after sterilization.
• Result: The color changing on test chart is the same between central part and edge
part indicate that air has been exhausted completely, with good vacuum system, good
condition for various parts, which can be used well. Conversely, equipment can’t be
used and need to be repaired if the color changing on test chart is uneven between
central part and edge part.

Note: Test package should be washed and can’t be scalded before using.

It should be open and dry for one hour once continuous test, then re-packaged without too
wet, too tight or too small.
• Prerequisite: Sterile package name, sterilization date or expiration date, and
packaging equipment check by name or code, seal a sterile marker.
As a result, only the description of the equipment and the cold vacuum residues, does not
mean that sterile items are sterilized qualified.

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 Chapter 9. General Maintenance and Urgency

Repair
NOTICE:
Do the maintenance and repair work according to the instruction or under the guidance of
professional, do not do it by oneself.
!!! Advise: Be sure the maintain and repair work is done on the condition of no power
and pressure.

9.1. Rise and carry

1. Cut off power.
2. Drain the water in the container.
3. Should be done by many people.

9.2. Faults Analyze

PHENOMENON REASON METHOD

Door switch is broken.

Door is not closed in Door switch pressing signal
place. (I03) is not detected by PLC.
Door switch is divergent. Please
adjust its position.

Door-lock switch is not pressed

after door-lock bounce off.
Door-lock switch pressing Please adjust door locks witch
Door switch open! signal (I05) is not detected by position.
PLC. Door-lock is stuck. Please adjust
door handle position or door-
lock position.

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 Water in pure-water tank
doesn’t arrive at high water Check water source and water
Water shortage!
level (I11) within 4 min injection pipeline.
during water injection.
High water level signal (I12)
Circulating water Circulating water tank is full.
in circulating water tank is
tank is full. Please let water out.
detected by PLC.
Starting current of pump is
Input signal (I17) of thermal
Vacuum pump overload. Reset thermal
overload relay is detected by
overload overload relay, maintenance
PLC.
according to instruction.
Temperature controller signal High water level float impure-
Evaporator
(I07) in steam generator is water tank is broken, please
overheating!
not detected by PLC. change float.

9.3. How to take down the cover:

Steps as follows:
1) Take down the side bolt.
2) Raise the cover upwards.

9.4. How to check safety valve:

In order to avoid the safety valve blocked, release it by steam every two months under
normal using.
1) Operate unwrapped program
2) Make the sterilizer chamber has pressure of 0.21Mpa.
3) Make the safety valve open for about 2 seconds.

9.5. How to change safety valve

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Only the professional worker can do it
When there’s fault, read the instruction to repair it, here are the particular instructions:
1) Discharge the fixed bolt of the safety valve, then take down the safety valve.
2) Change an eligible valve (standard: make sure the safety valve open when the
pressure between 0.25Mpa and 0.26Mpa).
3) Test the sterilization process.

9.6. How to change heater

!!! NOTICE: Be sure the power is cut of, the equipment has no electricity!
Only the professional worker can do it
1) Discharge the cover.
2) Take down the wire on the heater of steam generator.
3) Discharge all the pipe connected with the generator, take down the generator.
4) Open the cover of the generator then take down the electro thermal pipe.
5) Change the electro thermal pipe for a new one.
6) Fix the generator and connect the wire.
7) Install the cover.
8) Test all the working process.

9.7. How to clean the magnetic valve:

1) Discharge the cover.
2) Poke the stainless steel piece on the top of magnetic valve with screwdriver.
3) Life the loop of magnetic valve.
4) Open the valve with spanner.
5) Wash the valve with pure water.
6) Assembling the magnetic valve

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9.8. How to clean the water inlet filter
Water inlet filter locates in the side of water inlet pipe, it used to prevent impurity entering
the sterilizer chamber.
1) Disconnect the filters with screwdriver.
2) Wash the filter net with pure water.
3) Assembling the filter

9.9. How to clean the drain water filter valve.

Filter Cover

Filter

Water drain filter locates in bottom of inside chamber, it used to prevent impurity entering
water drain magnetic valve.
1) Disconnect the sterilizer cover.
2) Disconnect the filter net and filter cover with spanner.
3) Take out filter net.
4) Clean the impurity on the filter net with pure water.
5) Assembling the filter valve.

9.10. Door safety interlock device

Door safety interlock device can guarantee the safety for door opening. Door safety interlock
device function:
1) When the door closed to the suitable position, door position switch closed, program
can be started.
2) Magnetic lock can lock the door handle, so the door can’t be opened, and then
program can be started.

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 3) Only pressure between chamber and atmosphere is in balance, magnetic lock can be
opened, then the door can be opened.

Micro Switch

Magnetic lock

9.11. Pipeline description in the back of the sterilizer

1) Water tank drain valve: Drain water once a week to ensure that water tank is clean.
2) Vacuum pump drainage port: Connect this port to sewer or other place before you
start run.
3) Vaporizer drain valve: Drain water once a week to ensure that vaporizer is clean.
4) Vacuum pump inlet port: Connect this port to water pipeline before you start run.
For 1 and 3:
Water in the tank can be recycled automatic, maybe it is dirty after a period of time. So you
must change water once a week to ensure water is clean.
For 2 and 4:
Vacuum pump can work normally only when drainage port and inlet port are connected
correctly.

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