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MAST Sterilizer

Installation Manual
TD-ST-MAST-100-004

Document No.: TD-ST-MAST-100-004 V2.00


Issue Date: 2015-6-1
Print Date: 2015-6-1

The manual applies to MAST-A, MAST-V and MAST-H Pulse Vacuum Sterilizer.
 Application Range: it is used for the sterilization of medical device.
 Product structure and performance: The product is composed of chamber, door,
loading cart, transfer trolley, pipeline system and control system. The equipment
use saturated steam as sterilization medium to achieve sterilization quality on
high temperature condition. Pulse time can be set according to the requirement.

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Contents
Cautions and attentions______________________________________________- 1 -
1. Unloading equipment____________________________________________ - 4 -
1.1. Unpack and check_________________________________________________ - 4 -
2. Equipment installation___________________________________________ - 5 -
2.1. Preparation and requirements before installation_______________________ - 5 -
2.1.1. Installation space_____________________________________________________- 5 -
2.1.2. Foundation_________________________________________________________ - 6 -
2.1.3. Ventilation and heat dissipation_________________________________________ - 6 -
2.1.4. Drainage___________________________________________________________ - 6 -
2.1.5. Water source________________________________________________________ - 7 -
2.1.6. Steam source (if any)__________________________________________________- 8 -
2.1.7. Compressed air source_______________________________________________ - 10 -
2.1.8. Power Source_______________________________________________________- 11 -

2.2. Equipment locating_______________________________________________ - 12 -


2.2.1. Adjustment level____________________________________________________ - 12 -
2.2.2. Water, power and steam source connection______________________________ - 12 -
2.2.3. Power supply connection_____________________________________________ - 12 -

2.3. Equipment debugging_____________________________________________ - 12 -


2.3.1. Vacuum pump direction of rotation_____________________________________ - 13 -
2.3.2. Check every valve whether act_________________________________________ - 13 -
2.3.3. Empty-load test_____________________________________________________ - 13 -
2.3.4. Load test__________________________________________________________ - 13 -

2.4. Technical attached figure__________________________________________ - 15 -

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Cautions and attentions

Please strictly obey the following instructions during the operation.

During the term of use, the manual should be kept well.

Make sure all of received updates can be held in the manual.

When the use site or use unit are changed, the manual should be also
transferred well.
Please understand the symbols showed in the following table:
No. Symbol Instruction
1 It indicates high temperature and be careful of scald.

2 Note, please operate according to the manual.

3 On earth symbol

4 Here is voltage, please cut power before operation and maintenance

5 Emergency stop switch

In the operation manual, also using the following signs indicates the operation
content needs to be paid high attention.

It indicates to be paid high attention.

It indicates to be observed otherwise the equipment will be damaged.

It indicates to be observed strictly otherwise the personal safety will be


endangered.

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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.

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, catalogues 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 humidity and high temperature.

This equipment is not suitable for sterilization of hermetically sealed glass


bottles of liquid. 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 operating procedures, seriously endangering personal and
equipment safety.

The chloride ion is an important factor of stainless steel corrosion damage.


If use this sterilizer sterilizes items containing chlorine ion, indoor wall must be rinsed
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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 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 temperature 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.

It is recommended to evaluate the electromagnetic environment before


use equipment.

This equipment is designed and tested according to GB 4824 class A. In the


family environment, 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.

Equipment and accessories for handling, seating and storage should be aware of the
following signs, does not violate the provisions of signs.

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Fragile goods, transport handling should be handled with care.

Signs transport handling should be straight up.

Fear of rain, transport handling should be avoided when caught in the rain.

Lift, the location of hanging ropes for surface lifting cargo.

Sterilizer is properly installed on the properties of normal play will play an important
role, must not be ignored.

1. Unloading equipment
After equipment delivered to customer, user should pay attention to in the process
of lifting:
 Do not stand under the position of hoisting equipment.
 Should maintain enough safe distance around the hoisting equipment.
 Should use the qualified hoisting equipment.
 Adjustment focus of lifting appliances, identify the gravity, in order to make the
equipment hoisting in horizontal.
 During lifting, should pay attention to protect the external packing plate.

1.1. Unpack and check


After equipment is unpacked, firstly check the product nameplate on the type, name
and order whether they are consistent (the product nameplate is on the side of the
equipment)
 According to equipment packing list carefully check the equipment whether its
components are intact, whether damaged or loss, if have, should be recorded
carefully and contact us promptly.

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 Carefully check each connection or a fixed part whether they are loosened or
not because of long-distance transport, if there is, fasten it.
 Check and record the accessories taken with the equipment. Please refer to the
equipment packing list.

2. Equipment installation

Before installation of the equipment, if need,user can provide the equipment


model to our company, to ask for the installation diagram. During the installation
process, should be done by professional personnel under their guidance.
In-standard installation will pose a danger to human life and property, and to prevent
equipment normal, reliable running.
SHINVA is not responsible for all the risks that may occur due to in-standard
installation.

2.1. Preparation and requirements before installation


2.1.1. Installation space
The operation and maintenance of the device are considered comprehensively, and
the height of the room is at least 2.9 m. While installing the single leaf sterilizer, the
distance between the rear end and wall should also not be less than 0.5 m.

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Fig C-1 Installation Space Diagram

2.1.2. Foundation
In case of installing above the ground, the surface should be solid and smooth. In
case of installing above the second floor, the user should consider whether needing
reinforcing the floor as the case may be.
2.1.3. Ventilation and heat dissipation
In order to guarantee the normal running of the device and the comfortable working
environment better, it is recommended to install a set of appropriate ventilating
system in the working room, so as to control the surrounding ambient temperature
and humidity of the sterilizer. The specific requirements are as follows.

Fig C-2 Ventilation System

2.1.4. Drainage
Should choose the drainage at least larger than sterilizer configuration drainage
orifice size specifications of a pipe, the drainage tube alone leads to discharged
outside the trench, not with the building drainage pipeline communicated with
others (such as cleaning, floor drain), part of gas will affect or equipment in the
working process in the discharge to the other room.

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Fig C-3 Drainage Pipe Diagram

The drainage line should be installed along the outlet of the device from high
to low, without the back pressure; otherwise it will influence the sterilization or
drying effects due to the drainage difficulty of the condensed water.

When multiple devices share a main drainage pipe, the flow of the main drainage
pipe should be more than the sum of the drainage pipe flow as required by each
device.
2.1.5. Water source
The equipment’s water inlet pipe is 3/4 inch internal thread pipe.
If the pressure of water source is less than 0.1mpa,the vacuum cycle is not started.
The gauge with 0~0.6mpa measuring range and valve should be set on the water
inlet pipeline. The specific requirements are as follows:
1) Water source pressure is 0.15~0.3mpa,fluctuation is 10%.
2) Water Temperature: 5-20℃
3) Water Hardness: 71ppm(American Standard)
4) Pipe contacting to every equipment size shall not be less than 25 mm, Main
pipe’s cross-sectional area shall not be less than the sum of each branch pipe
cross-section.
5) Water pipelines shall be equipped with the main valve, filters, check valve,
regulator system, pressure gauge and safety relief device.

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Figure4-1 Water Supply Pipe Drawing


Note: if user’s water source pressure cannot reach 0.15~0.3mpa, user should install
a booster pump between filter and main valve on the figure4-1 and then adjust the
water pressure to 0.15~0.3mpa.

Do not use too hard water otherwise it will influence the performance
of pump and condenser.

Water steam generator must be softened water, otherwise it will affect


the quality of life of heating pipe and steam (applicable to devices with steam
generator).
The water supply quality for the equipment built-in steam generator should meet the
requirement in the table below(The table is from EN-285,Chapter 13.3. And Annex
B):
Table 4-1 Contaminations in the feed water for a dedicated steam generator

2.1.6. Steam source (if any)


It applies to the equipment need to connect steam source or the equipment need to
connect steam source and meanwhile having built-in steam generator.

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If the steam is supplied by external steam source, solid particles and condensed
water should be removed during steam delivery and the pressure should be
guaranteed at0.30~0.50mpa.

The sterilizer must be offered dry and saturated steam.


Sterilizer uses pressure steam as the sterilization medium, so the quality and
pressure of the steam determines whether the sterilization effect is good or bad.
Solid particles and condensed water should be removed during steam delivery and
the pressure should be guaranteed at 0.30~0.50mpa. If the pressure of steam
supply is too low, the cycle cannot be finished. If the pressure is too high, it will
influence the quality of sterilization effect.
If the steam supply pressure is too high(>0.5mpa), pressure reducing valve should
be installed on the steam supply pipe and the fluctuation should be less than 10%.
The quality index of solid particles in steam should satisfy the requirement of
following table requires(The table is from EN-285,Chapter 13.3. And Annex B):
Table 4-2 Contaminations in condensate from steam supply to the measured at the sterilizer inlet

Industrial steam pipe is 1 inch inter thread. (If it is not consistent with installation
drawing. The equipment installation figure shall prevail). If sterilization equipment is
far away from the boiler, the diameter of pipe should be increased to reduce pipe
resistance. If several sterilizers use one steam supply pipe, the diameter of pipe
should be considered overall.
To make sure the normal operation of equipment, the steam supply pipeline should
be insulated. For the timely observation steam supply situation, the steam source
valve and a 0 ~ 1mpa range of pressure gauge should be installed on the pipe
contacting to jacket or chamber, which is convenient for observation and control.
The specific requirements are as follows:
1) The pressure of steam is 0.2~0.5mpa and the fluctuation is ±10% before the
steam enters steam supply pipeline. If the pressure is too high, the pressure relief
devices should be installed on the steam supply pipeline. If multiple devices (same
specifications) share one pipeline, the cross-sectional area of main pipe should be
greater than the sum cross-sectional area of all individual equipment’s pipes. The size
of pipe contacting to the equipment shall not be less than 25 mm.
2) All of pipes should be equipped with thermal insulation layer.

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3) The system of water and steam separation should be installed on the main steam
supply pipe to make sure that the steam entering equipment is saturated steam.
4) The main steam supply pipe should be equipped with a stop valve, to ensure the
main line and sterilizer can be fully disconnected.
5) The main steam supply pipe should be equipped with a check valve, to ensure
that the, steam will not go back in case of accident.
6) The main steam supply pipe shall be equipped with filters, to make sure that
steam entering the sterilizer doesn’t contain solid particles and impurities.
7) The main steam supply pipe should be equipped with a pressure gauge for easy
to observe the steam pressure.
8) The specific nozzle position and diameter will be subject to equipment specific
installation drawing.

Figure4-2 Steam Supply Pipe Drawing

Note: The steam quality directly affect the sterilization effect of items, the user must
ensure that the steam entering equipment is dry and saturated steam. Every day
before starting the first cycle, operator should discharge condensed water in pipeline
then open the steam supply valve. If steam source is too high a, please adjust the
pressure relief valve.
2.1.7. Compressed air source
Compressed air pipe is Φ8 hose. Compressed air should be contacted to a place via
main pipe, the place is near the sterilizer and a cut-off valve, a pressure gauge, a Φ 8
plug-in through terminal quick change pipe joint should be installed. If there is no
compressed air source near sterilizer, 36 liters per minute with oil or oil free
compressor can be used for supplying compressed air to equipment. The specific
requirements are as follows:
1) The pressure of compressed air source is 0.5~0.7mpa.
2) Compressed air should be treated with removal of water and oil.
3) Compressed air pipeline should be equipped with the main valve, filters, check
valve, pressure gauge and safety relief devices.
4) It is best to install a compressor tank before the compressed air enter the
equipment, the volume of compressor tank should be about 0.5 m3.

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Figure4-3 Compressed air supply pipe drawing

The low end compressed air machine will make noisy during its work.
Please install it out of room as much as possible.
2.1.8. Power Source
Switch and breaker is as following drawing:

Fifure4-4 Power Drawing


Check whether the external power distribution box is normal, closed the external
power supply, close the key switch equipment.
Note: After the check of water source, steam source and compressed air source is
qualified, and then open the valve of water source, steam source and compressed air

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source, rotate the front panel key switch S3 for opening device. After the equipment
is opened, the equipment will automatically control steam pressure in jacket and
water level in built-in steam generator in order to meet the application conditions.

The power earth wire must be connected to the ground reliably!


Attention:
 Avoid installing in environment with heavy dust, oil mist containing conductive
particles, corrosive gas, and combustible gas.
 Avoid installing in the occasion of easily shock or vibration.
 Avoid installing in places at high temperature and high humidity or easily wet by
rain.
 Avoid installing in the environment with strong magnetic field.

2.2. Equipment locating


Move the equipment to the selected location. In the process of moving, take care
not to damage or scratch the decorative cover. If meeting special circumstances,
should record and mark well, remove the pipeline and the cover, the equipment is in
place, resumed them as they were. Remove the packing bag, take out document
taken with machine, and save it well.
2.2.1. Adjustment level
Put the equipment in the horizontal ground. In case of any uneven one, use thin iron
sheet can be to pad for an appropriate adjustment.
2.2.2. Water, power and steam source connection
Connecting water: in accordance with the attached figure 1, connect the softened
water or tap water respectively to the sterilizer steam generator water entrance and
filter of vacuum pump water inlet. Pipe can be connected by welding or screw thread,
after connection make the water test, the connection places must have no leakage.
2.2.3. Power supply connection
According to the specific location for equipment and installation requirements,
connect the water, electricity and compressed air with the corresponding position of
the sterilizer. Power control box is connected to the 220V single-phase power supply,
vacuum pump starter to 380V three-phase power supply.

2.3. Equipment debugging


Before the equipment leave from factory, in accordance with the relevant standards
part of the program has been set in advance. In the debugging process, user can
modify the program parameters according to the requirement of use. The specific
parameter settings please read ‘Operation Manual’.

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Before debugging, should firstly check whether the electrical part of wiring, socket is
off, loose, if there is fasten it; whether water in, drainage, and compressed air is
properly connected, otherwise adjust it and fasten it.
Open water inlet valve and the air compressor. Observe whether the pressure
indicating meets the requirements, if meeting the requirements do following steps
for debugging.
2.3.1. Vacuum pump direction of rotation
Turn on the power switch, the touch screen enters into the manual operation, press
F5, B button, and then touch ‘manual / automatic’ switch, switch it to ‘manual’ state,
now the vacuum pump starts. Observe whether the vacuum pump motor fan
rotation direction is consistent with the direction of the arrow marked on the pump
body, otherwise change the connection of any two load line in the three-phase load
switch.
Note: while doing this, if there are two people cooperate with each other, it will
reduce the inversion time of vacuum pump.
2.3.2. Check every valve whether act
In manual operation, one by one to open each pneumatic valve, watch whether the
red each pneumatic valve display head is out or not.
Open each electromagnetic valve, use a screwdriver near the top of electromagnetic
valve gently, should feel a strong magnetic attraction.
2.3.3. Empty-load test
Before running the program, should make pressure keeping test in accordance with
the instructions in the fifth chapter "Use and Operate”. If the test failed, it means the
pipeline connecting to chamber has leakage. At this time carefully check, eliminate
the leakage, to test again till to qualified, otherwise it will affect the sterilization
effect of equipment.
Parameters: please preset the parameters refer to work parameter in the fifth
chapter "Use and Operation ".
After the parameter is set, the normal operation of fabric, instruments, BD test
program can be run, the detailed procedure please read the fifth chapter "Use and
Operation". In the course of the program running, should check the tightness of pipe,
if pipe leakage point is found, timely eliminate it.
2.3.4. Load test
The above programs are run in the condition of empty-load, after empty-load test
must carry out the load test. In the load test, loading quantity of the non liquid
sterilization item such as instrument and fabric shall not exceed 80% of the volume
of the chamber, and should be placed on the shelf, each dressing package a should
be maintained with a gap of 10mm. Load test must make a sterilization effect t
detection on the package inner central point. According to the introduced in ninth

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chapter do the B-D test procedure, chemical test, biological test, and observe
whether the test effect compliances with the requirements.

It is allowed to modify program parameters the sterilizer in debugging


according to the actual situation, after modification, only test is passed qualified the
equipment can be put in normal use.

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2.4. Technical attached figure


Water, electricity installation diagram

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