1-MAST-C Steam Sterilizer Operation and Service Manual
1-MAST-C Steam Sterilizer Operation and Service Manual
1-MAST-C Steam Sterilizer Operation and Service Manual
This manual is suitable for the installation, operation and maintenance of MAST-C series normal
pressure steam sterilizer.
MAST-C sterilizer
3 On earth symbol
Here is voltage, please cut power before operation and mainte-
4
nance
In the operation manual, also using the following signs indicates the operation content
needs to be paid high attention.
Before any operation and maintenance of the equipment, please read and understand
the contents of each chapter, especially the contents with the above-mentioned marks. If you use
the equipment not by the way offered by my company, the equipment will be damaged.
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MAST-C sterilizer
The operation manual must be kept carefully so as to prevent the loss or damage, and
even the slight damage should also be avoided.
The operator is obliged to technically repairing and complementing partial contents, cat-
alogues and relevant chapters which are lost, damaged or inapplicable.
Anyone cannot tear down any content from the operation manual or take it out of the
operation manual in any case. If it does not conform to the content in the operation manual or it is
not involved in the operation manual, please contact the manufacturer for upgrading timely.
The operation manual should be kept at the ventilating and drying place away from hu-
midity and high temperature.
This equipment is not suitable for sterilization of hermetically sealed glass bottles of liq-
uid. If sterilizing the liquid above, please contact with our company, we will choose special sterilizer
for you.
Use this equipment to sterilize hermetically sealed glass bottles of liquid, it is easy to
contribute to bottle blasting accident because of operation personnel negligence or violation of op-
erating procedures, seriously endangering personal and equipment safety.
The chloride ion is an important factor of stainless steel corrosion damage. If use this ster-
ilizer sterilizes items containing chlorine ion, indoor wall must be rinsed every day, in order to avoid
deposition on internal stainless steel because of corrosion of chlorine ion and prolong the service
life of equipment.
On any position on the instrument seeing the symbol , it means operation manual
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MAST-C sterilizer
and relevant manuals must be referred in order to clarify the potential dangers and any measures
must be taken.
On any position on the instrument seeing the symbol , it indicates surrounding tem-
perature is higher; please pay attention to avoid scald.
The equipment needs daily maintenance and regular check during usage.
The product shall be the product in use at least once a month on a self-check, and make a record.
Units used in the product for the proper and daily maintenance of abnormal situation, should be
timely treatment.
The safety accessories (Safety valve, pressure gauge and so on), safety protection device,
measurement adjustment device and relevant instrument on the equipment should be tested and
recorded by user.
This equipment is designed and tested according to GB 4824 class A. In the family envi-
ronment, the device can cause radio interference so it needs to be taken protective measures.
It is prohibit using the equipment neat strong radiation source (for example, the shielding
of the RF source) otherwise it may interfere equipment.
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Content
1. Introduction ______________________________________________________ 4
2. Technical parameters ______________________________________________ 6
3. Installation and commissioning ______________________________________ 7
3.1. Unload____________________________________________________________ 7
3.2. Unpack and inspection ______________________________________________ 7
3.3. Equipment installation _______________________________________________ 7
3.3.1. Prepare and requirements before installation ________________________________ 7
3.3.2. Equipment location _____________________________________________________ 9
3.3.3. Adjust the levels _______________________________________________________ 10
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4.4.3. Main controller _______________________________________________________ 19
4.4.4. Solenoid valve ________________________________________________________ 20
4.4.5. Pressure controller: ____________________________________________________ 20
4.4.6. Pressure transmitter ___________________________________________________ 20
4.4.7. Temperature sensor: ___________________________________________________ 20
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7.1.1. Guarantee of the sterilization quality ______________________________________ 42
7.1.2. Quality of Steam Source ________________________________________________ 43
7.1.3. Water Quality Control __________________________________________________ 43
7.1.4. Environment of the Chamber ____________________________________________ 43
7.1.5. Preparation and Discharge of Objects _____________________________________ 44
7.1.6. Requirements of Sterilized Objects _______________________________________ 44
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1. Introduction
MAST-C series high pressure steam sterilizer uses steam as a heat sterilization factor.
Product design life of 8 years (or 16,000 times the sterilization cycle) (Note: This is
the design life of the period of failure environment estimation device according to
agreed standards, and the failure rate of actual use occurred irrelevant, inappropriate
will accelerate the use of equipment damage). After the sterilization process in ac-
cordance with the specified inner chamber cold air exclusion devices designed to
heat saturated steam sterilization factor, at high temperature, high humidity environ-
ment, the role of a certain time and pressure to achieve items can be steam sterilized
penetration.
Note 1: When the load may be sterilized microbial infection resistance than the
standard conventions resistance (for example, carry the BSE pathogen microorgan-
isms), you need to adjust the process parameters pressure sterilization, sterilization
time depending on the specific characteristics of microorganisms, and the corre-
sponding confirmation process before use.
Note 2: Bactericidal factor on the ability to kill micro-organisms should be agreed in
equipment and related facilities under normal operating conditions in order to en-
sure the effective killing effect, such as equipment failure, the external connection
system failures, the load and the load to be sterilized swing discharge, etc. Are likely
to interfere with sterilization factor in killing.
Note 3: As has been continuously updated and upgraded sterilization load, the oper-
ator shall verify the load to be sterilized apply to this device can be carried out related
operations after sterilization, it may give the device or load cause unpredictable dam-
age!
This manual is applicable for the following products:
Model Capacity Chamber size(mm) Overall size Net weight Power
MAST-C-100 100L 400X850(Φ×L) 1250×730×1660 260kg 11kva
MAST-C-135 135L 500×710(Φ×L) 1110×750×1742 400kg 13kva
MAST-C-185 185L 500×950(Φ×L) 1350×750×1742 460kg 13kva
MAST-C-300 300L 632×1000(Φ×L) 1415×890×1820 750kg 20kva
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The volume of the device will be different according to different specification, the
equipment in this manual is just in different volume, and the other parameters are
the same.
The sterilizer is only suitable for the medical items that high temperature
resistance and high humidity resistance. Cannot be used for sterilization of Vaseline
or other oil and powder!
The sterilizer using radial bolt door locking mechanism. Seal with good heat re-
sistance and flexibility of silicone rubber. Door center fitted with Pressure safety in-
terlock device - electromagnetic locks, in any case, only when the chamber pressure
within ± 10kpa can spin hands wheel. On the door it is also equipped limit switch,
only when the door close properly can start running the program. Thus, the door is
safe, reliable and easy to operate.
HMI uses a new liquid crystal display, can display graphics, dynamic text, dynamic
display workflow and time, temperature, pressure and other parameters during pro-
cess. They can be configured according to specific needs.
The machine uses modern control devices - programmable controller (PC machine)
to make program control, has a strong functions, high reliability, flexible features.
The machine use mechanical compulsory pulsation vacuum air exhausting method,
after repeated many times vacuum steam injection, the complete elimination of cold
spots sterilizing chamber, the air exhausting amounted to more than 99%, completely
avoid the temperature "dead" and "small load effect" to ensure reliable sterilization
effect.
The sterilizer has single door and double door type for option. Double door steri-
lizer embodiment may have bacteria with a sterile zone effectively isolated areas, to
meet GMP requirement.
The main controls and valves all use world-renowned brand of high-quality pieces of
supporting, greatly improving the stability and reliability of the equipment.
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Properly installation for this steam plays a very important role to keep its
normal performance during operation. So properly installation should not be ignored.
2. Technical parameters
Environment temperature:5℃~40℃;
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3. Installation and commissioning
3.1. Unload
When the machine delivered to the customer, during the lifting process should be
noted:
Do not stand beneath the lifting device.
Should be maintained around the lifting equipment has sufficient safety distance.
Use qualified lifting equipment.
Adjust the lifting appliance, identify the center of gravity, so as to keep the level
of lifting equipment.
When lifting, should be protected packaging.
After unpacking the device, first check the nameplate on product model, the
name and orders are consistent.
Carefully check if any connections or fasteners loose or not during long-distance
transport, if yes, please fasten it.
Inspection and record the equipment accessories.
Non-standard installation may bring the risk to human life and property,
and prevent equipment normal, reliable operation. We will not bear all the risk of
non-standard installation that may occur.
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Foundation: The surface should be solid, flat, bearing the weight shall comply with
the appropriate equipment requirements. As above floor installation, the user should
consider the need for corresponding parts of the floor reinforcement depending on
the circumstances.
Ventilation and cooling: In order to ensure the normal operation of equipment and
comfortable working environment, it is recommended to install a working chamber
should be suitable ventilation system to control sterilizer surrounding ambient tem-
perature, humidity.
Drainage: Should the selection ratio sterilizer drain port configuration is at least the
size of a standard drain, drainage alone will lead to a trench exhausted to the outside,
and not inside the building drain line other communication (such as cleaning, floor
drain, etc.), or part of the gas discharged from the machine in the course of their
work will affect the other rooms.
Drain pipe at the outlet should be installed from high position to low
position, which should not have the back pressure; otherwise they will discharge con-
densate affect poor sterilization or drying effect.
When multiple devices share a total drain, drain flow should be greater than the total
sum of drain flow each device needs.
anti-aging material.
Equipment installation, anchor bolts should be adjusted to ensure that the main drain
at the lowest point.
Water source: Used for vacuum system and steam generator. Connection size is 1/2
inch internal thread, pressure requirements: 0.2 ~ 0.3mpa, flow requirements, see
installation diagram. Installation should be connected to the valve and a pressure
gauge 0 ~ 0.6mpa in the water line. (Note: If the water pressure is higher than 0.4mpa,
should be appropriate to increase the pressure gauge range, to ensure that work at
full scale pressure gauge 2/3.)
If the water source pressure lower than 0.2Mpa, can’t start vacuum pro-
gram.
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The machine steam is from the built-in steam generator. The water for
steam generator should be soft water.
The cover of the machine and steam generator should be strictly ground
connected.
All the pipes and wires should be in vertical and horizontal and should be fixed effec-
tively.
Precautions:
Avoid installation in heavy dust, oil mist containing conductive particles, corrosive
gases, and flammable gas environment.
Avoid easily installed in electric shock or vibration.
Avoid installing in high temperature and humidity or places susceptible to the rain.
Avoid installing in a strong magnetic field environment.
Move the machine to the selected location. During the move, be careful not to dam-
age or scratch each decorative cover. Under special circumstances, make a record and
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mark after the piping and cover removed, the device in place, as is restored.
Remove the bag, took out the attached machine files and keep it in safe.
It should be noted in the handling process not to scratch the original ground.
The device can be placed directly on the ground level, if somewhat uneven, thin iron
sheet can be adjusted as pad.
The connection for water and electric.
Depending on the installation location of the equipment and installation require-
ments, the water and electricity with the sterilizer correspond to each other to con-
nect. The pipe joints should be sealed using a filler to prevent leakage, condensation
cannot have water and other liquids over the electrical box drip.
The equipment at the factory in accordance with the relevant standards set in ad-
vance of the program. In the debugging process, the user can use to modify the pro-
gram parameters.
Before commissioning, check the electrical part of the wiring, sockets, etc. Is off,
loose, there is fastened; water, drainage, connected correctly, otherwise it should be
adjusted and tightened.
Open the inlet valve, the water pressure to ensure compliance.
Turn on the power switch, move the cursor to , enter the password '0149' to log
into the system maintenance menu. Move the cursor to the manual operation, click
on the screen to enter the manual operation, the program automatically enters the
manual mode. Move the cursor to the B1 (water filling pump), press the Enter key,
then the injection pump is started.
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3.4.2. Check if each valve action or not
In manual mode, move the cursor to the solenoid valves corresponding label (F2
steam inlet valve, F3 vacuum valve, F4 ventilation valve F5 slow exhaust valve, F6
water filling valve, F7 circulation water valve), open the solenoid valves, with a screw-
driver and gently close the solenoid valve top, you should feel a strong magnetic at-
traction.
Before the program is running, should make leak test. If the test failed, then the inner
chamber communicating pipeline may have leaks. Then need to make double-check
to eliminate leaks and re-test until the test qualified, otherwise it will affect the effect
of sterilization equipment
Parameter settings: Check or check the parameter in operations programs.
After parameter settings, can run unwrapped, warped, BD & Helix and other pro-
grams. During the program running, check the pipe and sealing the door and found
the pipe steam leakage place promptly.
After the above unload program, load test should be carried out. In the load test,
loading equipment and other non-liquid type fabric sterilized items should not ex-
ceed 80% of the volume of the chamber and should be placed on the shelf, each
dressing kits and equipment package should maintain a gap of 10mm. Load test must
be wrapped inside the sterilizing effect of the center point can be detected. Run the
machine with B-D test program to detect chemical, biological testing, to observe
whether the detection results meet the requirements.
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4. Structure and working principle
The product consists of chamber body, door, shelves, piping systems and control
systems and other components. Saturated steam as the medium under high temper-
ature conditions, to achieve the effect of sterilization, you may need to set the pul-
sation frequency. See Figure III: assembly drawing.
There are electric heating films on the external of the chamber to ensure that cham-
ber maintain a certain temperature in order to reduce the internal steam condensa-
tion in sterilization process
Internal chamber with corrosion excellent stainless steel plate welded by special au-
tomatic welding machine, surface by mechanical polishing and electrochemical pol-
ishing, slip bright clean, corrosion-resistant and durable.
Out of the chamber, there are good quality insulation materials, beautiful and dura-
ble, reduced the heat radiation to a minimum, effectively ensure the work environ-
ment.
4.2. Door
MAST-C sterilizer doors mainly consists of door plate, bolt and locking mechanism,
seals gasket, hinges, doors cover, hand wheel, safety interlock systems and pressure
control components and other components.
Operating end called the front door, the back door is called the non-operating side
(only for double-door sterilizer). General configuration for the Single door machine is
left open, double door machine is front door right open, back door left open,
Firstly, remove the logo from the central of the hand wheel, and then use a screw-
driver crosswise decorative cover under the central screw, then remove the seat be-
fore the hand wheel. Then cover the top left of the door, remove the lower right
screw, then hand hold the door on both sides of the cover, lift it up after breaking out
slightly, then the door cover can be removed.
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4.2.3. Door bolt and locking mechanism
The door is locking by rotation driven the hand wheel to make the nice door bolts
overhanging.
Each spacer bolt factory has been adjusted, if found to leak the user generally do not
make adjustment shall be experienced personnel, otherwise the more stressed the
more worse.
Before closing each bolt in the fully retracted position, the hand wheel counterclock-
wise to the door limit position. Shut the door, so that clockwise rotation of the hand
wheel, automatic bolt protruding, and inserted into the front closure plate, and then
continue to rotate the hand wheel, when the operator heard the inner door cover
switch is pushed against the "click" sound, continue to rotate semi-circle to circle to
completely nip.
Prohibited to rotate the hand wheel in clockwise under the door to
prevent bolt extended and making the door cover damage!
Door switch mounted in the door cover, against oppression and bolt action, Double
door sterilizer front and back doors have a door switch. When the both door door
closed, to start the program. If the door is not locked properly, the program can’t
start to run, so as to avoid starting the machine with door is not closed. Under special
circumstances adjustable bolt on the plate, you can adjust the door switch operation
successively.
The door has a double insurance. In the bottom left of the door is equipped with a
limit switch, this switch is pressed at the door lock, switch on the device program
control circuit, that is to say the door is not locked, the program will not start. Once
the program starts, electromagnetic locks pop (Double Door Series ejected the front
door), then the hand wheel can not be rotated, did not open. When the sterilization
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process is complete, the chamber pressure was reduced to less than ± 10kpa, elec-
tromagnetic locks back, the door can be opened.
Structure
Sealing gasket is a specially processed heterosexual silicon rubber ring, compo-
nent of the material, the shape of the design, installation and maintenance of
the correct working and its normal life is critical, I use the seal circle uses a spe-
cially formulated silicone rubber material, which effectively ensure the stability
and reliability in high temperature environments.
Principle
The ring fixed to the main body of the sealing ring seat when the door is closed
during seal under the action of external forces close to the front of the cabinet
side seal plate sealing surface due to its trapezoidal shape, in a sealed process
will produce some distortion, in order to achieve the seal of the door.
Maintenance
Although the seal in the design and material selection have been fully taken into
account the long-term use, but several factors may affect the life of the seals
should be avoided in order to ensure longer seal life.
At the end of a shift, should be promptly steam into the sterilizer control to turn
off the main valve, so that the door in the open position, otherwise due to the
ring for a long time at high temperature compressed state, is bound to make it
gradually aging.
Use the six months to a year later, the ring should be removed with alcohol to
gently scrub seal, dry seal with the pressure of the back doors installed along the
end face of the door.
Use of the process should be taken to prevent collisions with hard objects to seal,
or easily create their permanent damage that cannot be reliably achieve the sealing
ring.
During use, often on the surface of the door seals and scrub a favorable impact on
the use of seals.
Failure
The following reasons can determine when substantially seal has failed.
Sealing gaskets significantly hardened surface, feeling lost when the elastic pull,
and pull the mesh pattern appears.
Sealing gaskets have been broken or cracked.
Remove and install door gasket
When needs to remove the gasket, after stopping all running programs open the
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door, and then the tape is removed from the seat ring seal trough.
When installed, press the sealing gaskets into the sealing groove to squeeze again.
Note: Because the general perimeter than the perimeter of the sealing strip seal
groove a little more, so when installed, to the extra length of the uniformly dis-
persed in the sealing groove
Remind!
When installing the seals, if another person can help, it will be easier!
The steam is generated from the built-in steam generator by heating the soft water
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in the steam generator. The steam generator outlet pipe connected with the lower
part of the chamber. On this steam entering pipe, there is a control valve F2.
The steam generator is designed to make the best performance and the best selec-
tion of the following configurations:
Body material made of high quality stainless steel, good welding quality, high overall
strength.
Heating elements made of stainless steel tube refined, with small size, long life and
other characteristics.
Water filling pump is high temperature and high pressure resistance pump. It is small,
high outlet pressure, reliable and so on.
Water level controller consists of upper, middle and lower detector probes, and has
a glass tube shows the various water level during working stages. .
The pipeline is used to exhaust the air the air, steam and condensate water in the
chamber through the lower part of the chamber. There is a valve on the vacuum pipe,
it is F3. Vacuum pipe and the exhaust pipe use the same line, the device uses an
external water cooling and water-saving systems, the steam in the chamber can be
The condensate water in the chamber will be drained through chamber drainage pipe
automatically. This pipe consists of filter, 1/4’’ solenoid valves, 1/4 ball valve, check
valve.
Check valve: a medium to allow only one-way flow valve, with a total of four, which
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is a common fault spring failure, rupture the seal pads or nuts loose in the perfor-
mance of the seal groove inner chamber inlet or backwater, back to steam, the valve
is straight-through check valve to prevent steam or water is returned outside the
chamber, affect the device performance.
After air through sterilizing filter to filter out impurities and bacteria, through the
return air solenoid valve F4 into the chamber in order to eliminate the negative pres-
sure working process of the formation of late, the intake air is dry sterile to prevent
secondary pollution of the sterilized items .
Air filter: The air filter is cylindrical, high-precision medical filter paper, filter accuracy
0.22μm, can filter out airborne bacteria and impurities.
Water supply pipe: Soft water pass through the filter, circulating water solenoid valve
F7, water filling pump and water filling valve F6 into the steam generator. The tap
water pass through circulating water solenoid valve F7 and water filling pump into
water tank and processing cycle.
Filter: The filters water pipeline carrying solid debris, effectively prevent sedimenta-
tion in the barrel and the filter to prevent it from entering the device.
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control system parts.
Safety valve: steam generator and chamber were equipped with safety valve, when
improper operation or equipment occurs when abnormal pressure, from the final
security protection. When the pressure is higher than the upper limit set value, au-
tomatically opens to reduce the pressure; below the lower limit set value, automati-
cally shut down.
Pressure gauge: For single-door sterilizer, the front door control terminal is equipped
with two gauges, a show steam generator pressure, the other is to show the pressure
within the chamber. Double Door Sterilizer case, at the rear end of the front end is
also equipped with the same instructions chamber pressure gauge.
Control system consists of main controller, display screen, thermal printer, solenoid
valves, pressure controllers, pressure transmitters, indicators, and display gauge and
other components.
Front panel mounted on the front end of the device cover, there are display screen,
thermal printer and a key switch.
Display screen:D3ALCD screen, the following features
160 * 160 dot matrix LCD display 3.2 inches
Display of temperature, pressure, alarm information
Support multi-language switching, wireless communications;
Back panel is only to suitable for double door sterilizer, it is equipped with five LED
lamps and an chamber pressure gauge.
LED lamps: Running lamp (green), Door closed lamp (yellow), Door locked lamp (yel-
low), Alarm lamp (red), End lamp (green).
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4.4.3. Main controller
Main controller:
PLC control, modular design of dedicated sterilizer controller. Highly integrated PLC,
using the MASTER series high-speed processor chip, can achieve 0.1 ~ 0.9μS / high-
speed arithmetic processing step.
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4.4.4. Solenoid valve
Control system output signal to the solenoid valve, the coil of the solenoid valve is
energized, connected to the line at both ends of the solenoid valve. Coil power, the
valve is closed.
When the steam sterilizer pressure reaches the upper limit set value, close contact is
heated.
When the steam generator pressure drops below the limit set value, open the con-
tactor for heating.
Internal chamber pressure signal into 4 ~ 20ma current signal, and then the module
into a digital signal, reflecting the internal chamber pressure is the actual value in the
touch screen. .
Working principle: within a certain range, PT100 resistance versus temperature is lin-
early proportional. The temperature rises, the resistance becomes large; tempera-
ture decreases, the resistance becomes smaller. At room temperature (20 degrees
Celsius) when, PT100 platinum resistance ohmic resistance value 107.79. After the
PT100 thermal resistance to temperature transmitter, temperature transmitter and
then passed by the analog module is converted to a touch screen shows the actual
temperature value.
Installation and use: platinum RTD attached to the lower chamber exhaust port posi-
tion, not with walls, water exposure. Wiring should be securely fixed to the terminals.
The control system uses a highly integrated chip as the main control chip, using the
touch-screen monitor as the man-machine interface, control the temperature and
pressure signals collected using standard analog modules: temperature probe PT100
resistance value is converted into a signal to the controller can accept digital; meas-
uring the pressure with the pressure transmitter converts the pressure signal into a
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standard 4-20ma current signal, processed into unit quantities. Benefits analog con-
trol is the process of sterilization process temperature and pressure changes contin-
uously programmable controller can be timely to detect, and displayed on the display
unit.
4.5.1. Switch on
Turn the power switch box three-phase knife switch (or breaker), and then turn on
the switch (key switch) on the front panel of the switch to the "On" position, the
switch is closed, 220VAC power supply via a fuse to the control box controller and
standard power (supply + 5V / 24VDC) power supply standard power supply to the
display and the printer. When the power is turned on, the control box PLC lights, ini-
tial display screen, a printer indicator light, and are on standby.
First, turn on the power switch, for MAST-C type pulsating vacuum sterilizer, after
closing the door Turn the hand wheel door, and then rotate the bolt in place 1-1.5
laps, after door limit switch is closed, returned to the PC input signal; when the front
door displays off state, the back door (if any) indicator shows the status of the input
gate signal has the device into standby mode.
Sterilizer front door switch that sterilization program is running, the temperature
level in the chamber and the inner chamber of the presence or absence of pressure
control, in order to ensure the safety of equipment and operator for two-door steri-
lizer is able to effectively ensure that the contaminated area and isolating the sterile
field.
When the machine powered on, after the self-test, the main controller is in working
condition. Heating water if not yet reached the low water level, the water level
reached after the evaporator and then automatically maintain pressure in a certain
range.
If you have a sandwich, mezzanine and the evaporator is connected, when the pres-
sure reaches the evaporator pressure limit, the main heating was stopped waiting for
a period of time the evaporator pressure falls under the pressure of the heating main
controller limit again, so circulated.
During program execution (non-sterile stage), if the water level below the high water
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mark for three minutes and injection pump (valve) were open so water cycle, the
water level maintained in the evaporator at the water level.
There is Pt100 temperature sensor for detecting the temperature of the water tank.
The default control the tank temperature is 35 ℃, when the water temperature is
higher than 35 ℃, and the injection pump circulation valve F7 open, Fill the water
External water supply is normal, rational water temperature control, to ensure that
equipment in standby or operational phase of the program, draining the device's
temperature is below 65 ℃.
After the key switch is powered on, the signals processed by the PLC, the steam en-
tering valve switch on or off according to the process needed.
"Unwrapped", "Wrapped" and "BD & Helix" programs, during pulse stage, it will evac-
uate three times to make a near vacuum inside the chamber to enhance the pene-
tration of steam. Run the program, when you're ready to enter the first stage is re-
placed, while the steam chamber, while exhaust steam, the inner chamber is filled
with steam or a mixed gas of air and steam to the injector evacuation system properly
evacuated. After the completion of the replacement into the pulsating stage, within
the chamber air, steam and condensate, the lower part of the chamber row soda oral,
vacuum valve F3 withdrawn. Vacuum exhaust and use the same line. When the cham-
ber pressure reaches the pulsation limit, F3 evacuation valve closed to stop the evac-
uation. When the pressure reaches the inner chamber pulsation limit, the exhaust
valve F3 is turned on, when the chamber is evacuated to a pressure drop when the
pressure transition (the default 20kpa) began evacuated. This cycle, until it reaches
the set pulsation frequency. After the pulse of F3 evacuation valve closed, water
pump stopped.
Pulsating three reasons: In general, the upper limit for the ripple 80kpa, pulsating
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lower limit -80kpa, evacuated a discharge rate of 80%; when evacuated twice the
discharge amount of 96%; when evacuated three times, the theoretical value of up
excretion 99.2%, so many times better pulsating vacuum effect, the system is set up
to six times.
Due to the different nature of the goods, Unwrapped, Wrapped, BD & Helix program,
such as vacuum, you need drying stage, when the chamber pressure drops to zero
exhaust, the program transferred to the drying stage. Water pump and the exhaust
valve open, relying WJS evacuation system, evacuated and dried. When the drying
time is reached, the exhaust valve, water pump stops, the end of the drying process.
In Unwrapped, Wrapped, BD & Helix other program, after the drying time over, the
air ventilation valve F4 open, then the chamber air pipe smooth and start air recovery.
Chamber pressure reaches back empty zero, the program delay and then turn end.
All the decoration covers of the machine using conventional carbon steel (stainless
steel can be customized), beautiful appearance, easy disassembly. In the device dur-
ing use, if desired, may be brought about on both sides of the outer decorative plates
in the middle of two hand-clasping, move up can remove the decorative side of the
outer cover.
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5. Use and Operation
Return
UP
OK
DOWN
Return Button
Press this button to turn back to the previous interface.
OK Button
Press this button to choose and confirm.
When parameter setting, press OK button to move the cursor.
Up
Press this button to left or up move the cursor.
As number plus button during parameter setting.
Page up function
Down
Press this button to right or down move the cursor.
As number minus button during parameter setting.
Page down function
The machine use PLC to control, LCD screen to display and press buttons to operate.
When powered on, the screen should be normal display, no flicker, distortion, no dis-
play abnormal and can be operated properly. Move the cursor to the selected icon or
parameter name, when this part of the color change will be reversed: for example,
When the cursor not moving on the icon, it shows as below:
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,
,
Table 2 meaning and function of the Icons in the screen
No Icon Function Remark
1 Program selection
3 Parameter setting
4 System maintenance
5 Alarm interface
The device is equipped with a total of 12 sets of programs, which divide into sterili-
zation program, test program and auxiliary program.
Among them, wrapper, rubber, user-define 01, liquid program, N-class flash, B- class
flash, prion belongs to sterilization program; BD & Helix, vacuum test belongs to
test program; preheat program, drying program is part of the auxiliary class pro-
gram
Move the cursor to and press ok, you may see those programs as below.
25
Steriliza- Steriliza- Drying Pulse
Program tion tion time time count Suitable Loadings
type
temp/℃ /min /min s
Un- Solid or hollow items in high-tempera-
134 4 6 3
wrapped ture resistance without packaged.
Solid or hollow items, fabric in high-
Wrapped 134 6 10 3
temperature resistance with packaged.
Non high-temperature resistance rubber
Rubber 121 1200 600 3
or fabric
Use-de- User can set the parameter according to
134 360 300 3
fine01 requirement.
Liquid 121 1200 ---- ---- Liquid in open lid containers
Single piece unwrapped solid instru-
N-Quick 134 210 30 ----
ment
Single piece unwrapped hollow instru-
B-Quick 134 210 30 2
ment
For loadings with bacteria of difficult
Prion 134 1080 300 3
to kill
Check the steam penetration effect and
BD&Helix 134 210 480 3
cold air eliminate effect
Leak test Vacuum:300s,testing:900s Check if any leakage on the machine
Pre heat 121 210 240 1 Pre heating the chamber
Drying ---- ------ 600 ---- Make drying for the loadings
【105 138】℃
26
5.2.2. Program Description
Prion program applicable to kill bacteria and viruses that can’t be killed by the ordi-
nary sterilization
N-class fast program applies only to the state under the hot pan, the user emergency
sterilization operations on a single bare instruments, while completion of sterilization
must be used within four hours, and the need to prevent the causing of the instru-
ment when shipped to the point of use secondary pollution of the environment and
other factors.
Tips: run flash or N- class B- class fast fast-track program, for the shortest running
time, we need to remove the shelves and extra tray.
BD & Helix program with special equipment for testing the effect of cold air exclusion
and steam penetration effect, such as standard BD package, disposable packages,
such as BD, the program parameter value according to the parameters most com-
tion 3.5 minutes), as adopted by the hospital equipment or a different paper, refer-
ence should be made using equipment or paper request to modify specific parame-
ters. But also with the cold air dedicated lumen type PCD test length of the lumen
device to exclude the effect of steam penetration effect, this program parameter val-
ues according to the parameters most commonly used PCD device manufacturer re-
27
quirements and setting (134 ℃ sterilization 3.5 minutes ), as used in different hos-
pitals and reference should be made to modify the requirements for using equipment
specific parameters.
Leak test program for testing the equipment portion of the sealing device or the
pipeline situation under negative pressure inside the chamber and connected. In the
process of debugging the device or conventional routine testing, especially after
long-distance transport, there may be loose and so the line (or B-D test failure), the
time, you can select the program to be tested. It is mainly used to test sterilization
equipment vacuum leaks, to seal state detection pipeline. This test is under sterile
chamber within the premise of the load. After running to the testing phase, the pres-
sure change within 600 seconds does not exceed 1.3kpa, vacuum leak tested. If the
test is abnormal, it must repair. Check the door seals and piping system within the
chamber turned part, etc., to identify leakage points, removed, re-test until the test
is normal. This program is only for testing and not as sterilization is qualified and
reliable verification.
Pre-heat program, the drying process as an auxiliary class procedure must be strictly
in accordance with the procedures applicable conditions of use when using this type
of program. Pre heat program, when the apparatus of the first pot of the program
may first load operation preheating program causing the device to warm up in order
to achieve better and faster drying effect and sterilizing effect.
Drying program can be dried to a separate article, set the appropriate drying time
according to different requirements, to achieve the requirements of article drying.
If you want to modify the program parameters required by the maintenance staff or
the person who familiar with the operation and management. This should be car-
ried out with entering a password.
In powered-on initial screen, select the system parameters setting icon , enter
the system parameters screen
28
System PARA:
Pressure Point
Preheat
Print mode
Time/Date
Language
USB State
F0 printer
Pressure point: adjust the atmosphere value according to local atmosphere. The
boiling point will be automatically calculated according to the atmosphere value.
Preheat: turn on the preheat mode, the steam generator and chamber in wall
will be preheated automatically in the stand-by status.
Print mode: select print or do not print.
Time/Date: set present time and date.
Language: select language.
USB state: view USB connection.
F0 printer: Select whether to print the F0 value, the default does not print.
29
30
XX/XX/XX
XX:XX::X
X Select parameter
Chamber---P1:XXXX kPa
Chamber---T1:XXXX°C
Chbr-out---T2:XXXX°C
NO
Generator-T3:XXXX °C Whether show
Door state:closed Parameter
page
YES
System PARA:
Pressure point
Preheat
Print mode Whether show at- NO
Time/Date mosphere parameter
Language value page
USB State
F0 printer
YES
:
Adjust the atmospheric pressure value according to the local atmospheric pressure
and the boiling temperature will be calculated automatically.
Standard atmospheric pressure is a unit of pressure equal to 101kpa. (i.e.
0.1Mpa=101kpa) It decreases with the increase of altitude. Under 3km, every 1km
increase of altitude the atmospheric pressure will decrease about 10kpa.
If you have no idea about the local atmospheric pressure: when the atmospheric
pressure is 101kpa, the displayed chamber pressure P1 will be 0kpa under the door
31
opening status; the door can be opened/closed under the pressure of ±5kpa; user
could get to know the local pressure according to the door status. For example: the
chamber pressure is -6kpa under the door opening status, the local atmospheric pres-
sure will be 95kpa.
XX/XX/XX
XX:XX:XX
Select parame-
Chamber---P1:XXXX kPa ter
Chamber---T1:XXXX°C
Chbr-out---T2:XXXX°C
Generator-T3:XXXX °C NO
Whether show
Door state:closed Parameter
page
YES
Select ‘preheat’
Initial page
press ok
System PARA:
Pressure point
Preheat
Print mode Whether show pre- NO
Time/Date heat mode page
Language
USB State
F0 print
YES
Parameter page
32
5.2.4. Maintenance and advance parameters
Select the system parameters setting icon , input password 0149 and enter the
system parameters screen
Equipment ID
Display equipment series number
Equipment volume
Displays the current chamber volume (L)
Cycles count
Displays program run times
LCD
Displays the current screen brightness, range [160 200]
Deviation settings
P1: Chamber pressure deviation setting range [-10 +10] kpa
33
5.3. Program running
When the machine powered on and without alarm, it will stop at the initiate interface.
Chamber pressure-P1:Pressure in the chamber
Chamber temperature-T1:Temperature in the chamber
Chamber out temperature-T2:Temperature on the chamber wall
Water tank temperature-T3:Temperature of water tank
Operation method: Press Up and Down button to choose the waited item and then
press OK to enter the corresponding interface.
After selecting the wanted program, it will enter the interface as below:
P1: XXXXkPa T1: XXX.X℃
T3: XXX.X℃ T2: XXX.X ℃
Program code: XX
Type: XX
Parameter: XXX.X℃/XXXX S
Door state:Door closed
34
5.3.4. Program running interface
Press to start the program and enter the program main flow interface:
XX # XXX
P1: XXXXkPa T1: XXX.X℃
Preparation
Door state:Door closed
XXX # XXX
P1: XXXXkPa T1: XXX.X℃
End
Running time:XX:XX
Please open the door!
It shows the various stages of the program name and equipment within the room
temperature and pressure state data on the screen. A major equipment sterilization
cycle includes the following phases:
Preparation phase: the preparation phase evaporator device and the pot wall pre-
heating, preheating temperature reaches the set, if enabled printing capabilities,
then the preparation phase must complete the print header.
Purge stage: began to steam into the chamber while the exhaust valve open, remove
the inner chamber cold air.
Pulsating stage: pulsating exclude cold air, first exhaust smoke or pulsating vacuum
to the lower limit, then begin to boost the intake pulsation limit, and then proceed
with the exhaust or vacuum so the cycle until it reaches the pulsation frequency, play
try to completely rule out the effect of cold air.
Heating stage: internal boost heating chamber, when the delay reaches sterilization
temperature into the sterilization phase.
Sterilization stage: control the temperature and pressure within the chamber is
maintained at a certain stage in the sterilization of control, until the end of steriliza-
tion.
35
Exhausting stage: Exclude the steam chamber and reduce pressure within the cham-
ber.
Drying stage: After the pressure within the chamber sterilizing chamber exclude
items to dry.
Balance stage: If within the internal chamber pressure is not the door switch pressure
range, it will automatically open the door until it reaches an equilibrium pressure
conditions.
End stage: buzzer sounds, and the monitor will prompt the end.
Correspondence between the duty cycle and time pressure, factory-set "naked pro-
cedures" ,for example, the following diagram:
During sterilization, if want the check the data information, press the button
Parameter setting:
xx # xx xx xx
Sterilization time:xxx min
Sterilization Temp.:xxx ℃
Drying time:xxmin
Pulse count:x
Pulse upper limit:xxxxkPa
Pulse lower limit:xxx kPa
Purge time:xxx s
36
5.3.6. Output information
In the main flow interface, press button to check the output signal information. All
the working state of the parts showing here:
In main flow interface, select process date button, it will show as below:
Information
Pur:0:00 Ste:0:00
Pv1:0:00 Max:0:00
Pp1:0:00 Min:0:00
Pv2:0:00
Pp2:0:00
Pv3:0:00
Pp3:0:00
37
Pp3: heating the actual running time
Ste: sterilization time operating values
Max: maximum temperature sterilization phase
Min: minimum temperature sterilization phase
In the main flow inter, select the alarm icon to enter the alarm screen. If there
is a corresponding alarm display will pop up warning dialog screen, for example, E02
chamber over-temperature alarm.
P1: XXXXkPa T1: XXX.X℃
P2: XXXXkPa T2: XXX.X℃
Program code:XX Stage:XX
Alarm code:XX E02!
XXXXXX Chamber over temperature
Error:XX-XX-XX XX:XX:XX
Clear:XX-XX-XX XX:XX:XX
During program is running, do not operate away from the equipment, observe the
operation of the equipment;
38
The operator manually program the process can only be familiar with sterilization
equipment and items to be sterilized characteristics do.
If the monitor no response, optional power restart a way to check whether the prob-
lem of the control system.
(can be set) or less, the doors open gap of about 10mm wait about 10 minutes,
then open the big doors, remove the liquid bottle.
When loading or come up liquid bottle, should be handled with care to avoid
bumps, knocks and bumps.
39
6. Error analysis and trouble shooting
40
Leakage in vacuum pipeline;
Flow ball valve improperly ad-
Check the all the pipes and joints con-
justed;
nection and make leakage test;
No water source or low water
Adjust ball valve;
pressure;
Check if has water supply or not;
Jam in water ejector or pipeline or
Vacuum too slow, Check or replace pressure transmitter;
Pressure transmitter failure;
the negative pres- Repair or replace the check valve;
5 Chamber steam trap pipe check
sure can’t reach the Check the water ejector, solenoid valve,
valve damage;
standard. pipeline and make clean;
Vacuum valve or water filling
Check solenoid valve or pump;
pump not open;
Make chemical descaling for condenser,
Water lack in water tank or circula-
piping system and pumps;
tion water valve broken;
Adjust the pressure set
Too much scales in the pipe;
Altitude is too high.
Check the coil of the solenoid valve;
Solenoid valves no Coils error;
6 Check the wire connection of solenoid
action. Wire connection loosing;
valve;
Steam generator or
Leakage in pipeline; Check and stop the leakage;Clean the
jacket pressure high
Jam in chamber slow draining chamber slow draining pipe;
but chamber pres-
7 pipe; Check the solenoid valve;
sure can’t reach the
Solenoid valve damage; Check the wire connection of the sole-
required or F2 can’t
open Wire connection loosing. noid valve.
Main heater is too slow; Check the main heater
Heating speed is too
8 Pulse times are too few or purge Increase the pulse times and longer the
slow
time too short purge time;
Pressure reached, Steam trap open too small, there
Adjust steam trap open frequency;
9 but temperature is water in the pipe;
Add pulse times;
can’t reach Pulse times are too few.
Temperature show 0 Temperature sensor not con- Check the temperature sensor and re-
10
or 200 ℃ nected well; connect the wires;
Pressure show - Pressure transmitter not con-
11 Reconnect the pressure transmitter;
100Kpa nected well.
Ground line is not connected
Temperature and Reconnect the ground line;
well;
12 pressure keep jump- Check the clear the High-intensity mag-
High-intensity magnetic field
ing netic field;
around the machine.
Temperature can’t
13 comply with pres- Calibrate the temperature; Calibrate the chamber temperature;
sure
Water level float(Sensor)wire
Steam generator Check and reconnect the power;
connection error;
14 water level detect- Check and replace the water level float
Water level float(Sensor)dam-
ing error (Sensor);
age
Steam entering valve jam or ex- Check and clean solenoid valve;
Low temperature
15 haust valve leakage ; Adjust chamber pressure limit higher or
alarm
Cold air not exhaust thoroughly; add pulse times or purge time;
Water lack from water source; Check water source supply and try
Steam generator
Water entering filter jam; again;
16 water filling over
Steam generator water level de- Check and clean steam generator water
time
tecting sensor failure; filling filter core;
41
Check water filling pump; Replace water level detecting sensor;
Repair or replace water filling pump
Chamber pressure transmitter er- Check circuit and replace pressure trans-
ror; mitter;
Chamber over pres-
17 Chamber PT100 temperature date Calibrate the temperature sensor devia-
sure
low; tion;
Solenoid valve can’t sealing well; Clean filter and solenoid valve ;
7. Sterilization Quality
For any disinfection and sterilization device, no matter which type, steam ex-
haust by gravity or automatic program control. In case of achieving the reliable ster-
ilization effect, in addition to the design, manufacturing quality and perfect mainte-
nance of the device, correctly mastering the basic knowledge of the disinfection and
sterilization, knowing the working principle of the device well, strictly executing the
operation rules of the disinfection and sterilization work, and taking every provisions
relevant to the sterilization seriously, are the human factors of gaining the successful
sterilization.
7.1. Self-protection
During the sterilization, the staff must have the self-protection consciousness and
adopt the self-protection measures, so as to prevent on the harm to the staff.
42
necessary to note that the machine cleaning cannot replace the manual cleaning. For
some pipes, precision instruments and parts difficult to clean must be cleaned man-
ually. In addition, the cleaning devices must be cleaned and maintained, so as to
avoid the failed machine cleaning.
43
d) If qualified, the partition of the device can be made. The sterilization device
adopts the high temperature steam as the sterilization medium and uses the vac-
uum pump for vacuum pumping, and the air compressor provides the compressed
air for the door sealing and pneumatic valve. Therefore, it will have some influence
on the surrounding environment. It is recommended that the operating end of the
front door and non-operating end of the back door shall be separated by the color
steel plate or other materials after the device takes place. In this way, it will prevent
the heat and working noise from influencing the surrounding environment effec-
tively, and improve the working conditions of the disinfection room greatly.
7.1.5. Preparation and Discharge of Objects
The dressing fabric should have the moderate tightness while folding the packs,
so as to facilitate the permeability of the steam.
When the packs are arranged in the shelf, it is necessary to keep the clearance
of 10 mm mutually, and the loading capacity cannot exceed 90% of the inner cham-
ber volume, so as to facilitate the smooth circulation of the steam.
The commercially available aluminum lunch box and porcelain enamel shall not
be used for carrying the sterilized objects. The sterilized objects should be carried
by the appliance with the air vent.
7.1.6. Requirements of Sterilized Objects
It is necessary to sterilize the similar objects in a batch to the greatest extent,
and avoid the instrument packs from touching the cotton fabrics packs directly.
The volume of objects pack for the sterilization shall not exceed 30cm× 30cm×
50cm.
The objects pack should not be strapped too tightly, and should be pasted and
sealed with the chemical indicating the sealing rubber gasket. The chemical indicat-
ing card shall be placed in each objects pack.
The metal drum pack should be placed below the dressing pack.
44
time, sterilization temperature and other parameters. Through observing these val-
ues and whether meeting the requirements, the good or bad sterilization effect can
be judged preliminarily.
② Stationary Point Thermometer Detection: The structure of the stationary point
thermometer is the same as that of the thermometer, but its highest temperature
can reach 180℃, and it needs being less than 50℃ while using. It shall be placed in
the central position of the sterilization pack during using. Several stationary point
thermometers are used for testing the temperature of various points. After steriliz-
ing, observe whether the displayed temperature value achieved the required tem-
perature. The defect of this method is that it only displays the temperature, without
indicating the duration of this point at this temperature.
③ Thermocouple Detection: This method is to put the electrode of the thermo-
couple into the part to be tested by the sterilizer, close the cabinet door and lead
out the wire. The verification device makes the data analysis, and the computer dis-
plays the tested temperature value of various points in due time. By using this
method, the uniformity of the temperature in various points and the stability of the
sterilization temperature in the inner chamber of the sterilizer can be detected.
7.2.2. Chemical Detection Mode
① Using a chemical indicating card: Such kind of indicating cards can be divided
into the chemical indicating card used for the pressure steam sterilization effect de-
tection under three temperatures as 115℃, 121℃ and 132℃. While using, the
chemical indicating card, which can not only indicate the temperature but also indi-
cate the duration of the temperature, shall be put into the middle part of the dress-
ing pack to be sterilized. Upon a sterilization cycle, the indicating card shall be taken
out, and compared and judged with the standard color. If the color of the indicator
is deeper than the standard color, the sterilization shall be qualified; conversely, the
sterilization shall be made again.
② Using a chemical indicating adhesive belt: This adhesive belt is coated with
tackiness agent at one side and chemical indicator at the other side. It can be used
as indicator distinguishing ‘Sterilized’ and ‘Non Sterilization’, and also can be pasted
on the surface of the dressing pack as the pack strip seal. After finishing the sterili-
zation, the uniform blackening of the indicator color can indicate whether receiving
the sterilized treatment, thus further proving the possibility of the successful sterili-
zation.
The chemical indicator for the detection must be approved by the hy-
giene department, and used within the period of validity.
45
7.2.3. Biological Detection Mode
The biological detection means the final detection method of using the live microor-
ganisms to detect the sterilized objects, so as to identify whether the microorganisms
in the sterilized objects die fully, and assess whether the sterilization device makes
the qualified sterilization.
Calibrating the indicating bacterium: It adopts the international ‘Bacillus Stea-
rothermophilus’ with the strongest heat resistance which is most difficult to be
killed as the sterilization indicator.
Culture Medium: The culture medium for the test is the bromocresol purple
peptone water medium.
Detection Method: Two sporeforms slices of Bacillus Stearothermophilus are
respectively put into the small paper bags for the sterilization, and placed in the
middle part of the standard test pack (the pack dimension of 25cm× 30cm× 30cm).
The test pack is put above the steam drain of the chamber. After finishing the steri-
lization, the standard test pack is taken out and put into the bromocresol purple
peptone water medium under the sterile conditions. Upon culturing for 7 days at
56℃, observe the color change of the culture medium. While detecting, the nega-
tive control and positive control are set.
Result: The colors of all culture media are not changed, which is judged to be
the qualified sterilization. In case that the purple turns into yellow, it shall be re-
garded as the failure of the sterilization.
Treatment: In case of the disqualified sterilization, this batch of objects can be
firstly stored temporarily, and the possible causes of the failed sterilization can be
found. Then the sterilization treatment is made again. Also multiple biological indi-
cators in the same manufacturer or the same type of the biological indicator in vari-
ous manufacturers can be used for detecting the sterilization effect of the sterilizer
again. Carefully check the production date and effective date of the biological indi-
cator, whether having the damages, and whether having the pollution during the
culture process.
It is allowed to use other detection methods approved by the Ministry of
Health, and make the biological detection on the sterilization effect by reference to
the instructions.
Before the normal use upon debugging or after the overhauling, the device
should receive the qualified biological detections continuously for three times, and
then can be put into use.
Three methods as physical detection, chemical detection and biological detection re-
spectively have their different purposes and significances, therefore, they cannot be
replaced each other, and should be mutually combined for using.
Three methods as physical detection, chemical detection and biological detection re-
spectively have their different purposes and significances, therefore, they cannot be
replaced each other, and should be mutually combined for using.
46
Physical detection--It can describe the running status of the sterilized device, and can
intuitively display the time, temperature, pressure and other relevant parameters
during the working process.
Chemical detection--It can detect whether finishing the sterilization process, under-
stand how the penetrating power of the steam on the pack is, provide the first visual
inspection instantly after finishing the sterilization, and assist to judge the steriliza-
tion effect.
Biological detection--It is mainly used for the final judgment of the sterilization effect,
with the high cost and long time, so it cannot be used for each pack or each boiler.
7.2.4. Bowie-Dick Test (BD Test)
BD test was designed by two Scottish microbiologists as J.H.Bowie and J.Dick in 1963,
specialized in testing the air discharge effect of the vacuum pressure steam sterilizer.
Vacuum Test Chart: The mixture composed by various chemicals is manufactured
into the indicator ink by the fixed carrier. The indicator ink is printed on the paper
with some air permeability and the particular size by the specific printing mode,
forming the fixed pattern, and then a vacuum test chart for B-D test shall be gener-
ated. The chemical indicator in the test chart has the sensitivity on the residual air,
and can detect whether the residual air exists in the test pack.
BD Test: This test should be made before the sterilization for the first time every
day. The test is to place the vacuum test chart into the middle position of the test
pack (the one-off B-D test pack can also be used), then the test pack is put into the
steam drain of the chamber. Close the cabinet door, and make the sterilization test
in accordance with the set sterilization parameters (134℃ 4 min). After finishing
the sterilization, open the cabinet door, unfasten the test pack, take out the test
chart, and observe the testing result.
Preparation of Test Pack: The test pack is composed of the pure cotton linen with
the size of 46~50 cm× 80~90 cm. The linen is horizontally folded for three layers,
and then vertically folded for six layers. The folded linens are stacked one by one up
to the height of 25 cm. While stacking, the linens of each layer are placed with right
and left alternately in accordance with the folding sides, so as to make the thickness
at both sides equal. After the lines are placed properly, the vacuum test chart is put
between the lines of the middle layer, and then is wrapped up by the cloth, and the
surface is fixed by the chemical indicating sealing rubber gasket, so it becomes a
test pack. For the size of the entire test pack, the length is about 27~30 cm, the
width is about 23~25 cm, the height is about 25~28 cm, and the weight is about 4~5
kg.
Result Judgment: The test chart is blackened and uniform, that is to say, the color
of the midsection is consistent with that of the edge section, which indicates that
the air is discharged thoroughly and the vacuum pumping system of the sterilizer is
favorable, so it can be used. If the test chart changes color without the uniformity,
generally the color of the midsection is shallower than that of the edge section,
47
which indicates that the air is not discharged thoroughly and the performance of
the sterilizer is not good, so it can be used after repairing.
Notes: Before using, the linen should be washed once at least, but cannot re-
ceive the hot iron, because the excessive drying will influence the testing result. For
the reused test pack, the linen must be cleaned. During the continuous testing, the
pack should be opened every time, and the linen is dried by airing for an hour. Then
repack again. The excessively humid linen can influence the testing result. The pack
should be loose, and should not too tight or too small.
Essential Conditions: Name of the sterilization pack; Sterilization date or expiry
date; Name or code of the verifier and packer for the instruments; Sterilization
mark in the sealing position.
The result only describes the vacuum status of the device and the residual
quantity of the cold air, without expressing whether the sterilized objects have the
qualified sterilization.
48
8. Appendix
Switch on the water source that connected with the sterilizer and check whether the
The device is kept in the power-up state. Preheat the device for the program run-
ning.
Open the front door, and loading the items. It is necessary to leave the gap among
the packs. Do not paste in the vessel wall and door plane all around.
During the sterilization process, the operator shall not be away from the device,
should closely observe the running conditions of the device. In case of the abnormality,
Carry out the monitoring of the sterilization effect, record and keep in the archives,
After finishing the sterilization, open the door and take out the items
Open the door and turn the power switch to the ‘O’ position.
49
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
A A
MAST-C-135/185 Installation Diagram
B 1350(1110) B
750 MAST-C-185: 1350mm MAST-C-135:1110mm Safety valve
C C
power cable
1720
D D
Technical requirements
external thread 1)Technical datasheet
R1/2''
670 a a)Net Weight:135L:360kg,185L:420kg
E c b b)Overall dimension(LxWxH):135L:1110X750X1712mm,185L:1350X750X1712mm E
2)Technical requirements
700(460) a)Power
MAST-C-185: 700mm MAST-C-135:460mm internal thread external thread
Rc1/2'' R1'' 380V\3 phase\50Hz neutral wire: bule color, earth wire: green and yellow color
not less than 13kVA,a circuit breaker must be installed in switch box ,
F The enclosure must be strictly grounded. F
① soften water inlet pipeline
b)Water souce
② Steam drainage pipeline Water souce 0.15~0.3MPa,soften water,hardness ≤ 2mmol/L,temp.≤20℃,
③ steam generator drainage pipeline water consumption 1m3/h
c)Water drainage
③ ① diameter of drainage pipe≥DN100,High temperature resistant metal material,
G
No. a b c ② the equipment has no pressure drainage, can not be mixed with other indoor drainage pipes. G
Name water inlet port steam drainage port steam generator water drainage d)environment temperature
Equipment installation area while working temperature is not higher than 35 ℃.
Nozzle Type external thread internal thread
MAST-C-185:1800 MAST-C-135: 1560
e)illumination
Nozzle size 1/2" 1" 1/2" Install explosion-proof floodlight in the installation area for easy maintenance.
1800(1560)
I I
J 标记 处数 文 件 号 签 字 日期 图 样标记 数量 重 量 比 例 J
设 计 工 艺 Installation drawing 1:8
1:10
制 图 标 准化
共 张 第 张
校 对 批 准
审 核 日 期 山东新华医疗器械股份有限公司
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20