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User Manual

This document provides an operation manual for the Shinva XG1. U Pulse Vacuum Sterilizer. It details the structure and components of the sterilizer, its performance specifications, principles of sterilization using steam, and safety considerations. The manual instructs users to carefully read and follow the guidelines to safely and effectively operate the sterilization equipment.

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0% found this document useful (0 votes)
108 views

User Manual

This document provides an operation manual for the Shinva XG1. U Pulse Vacuum Sterilizer. It details the structure and components of the sterilizer, its performance specifications, principles of sterilization using steam, and safety considerations. The manual instructs users to carefully read and follow the guidelines to safely and effectively operate the sterilization equipment.

Uploaded by

nr26b82cd8
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 131

TD-XT-D004-001 V2.

19

Pulse Vacuum Sterilizer

Operation Manual
TD-XT-D004-001 V2.19

Document No.: TD-XT-D004-001 V2.19


Revised Date: 2020-8-20

This Manual is applicable to the installation, operation and maintenance of


Shinva XG1. U Pulse Vacuum Sterilizer.
Product Information:
1) Structure and composition:
This product consists of cabinet body, cabinet door, disinfection vehicle,
handling vehicle, pipeline system and control system. Using saturated steam as
medium, the effect of disinfection and sterilization can be achieved under high
temperature conditions, and the pulsation times can be set as required.
2) Product performance: For sterilizers with sterilization temperatures of 121 ℃
and 134 ℃ respectively, the maintenance time shall not be less than 15min
and 3min respectively.
3) Scope of suitable (enabling) use of products: for medical units,
pharmaceutical and other units to do sterilization of medical liquids, surgical
instruments, dressings and fabrics.
4) Contraindications: None
5) Main bactericidal factors and intensity:
This equipment uses humid and hot steam as sterilization factor.
See Appendix D for the intensity data of sterilization factors.
6) Principle of sterilization:
The equipment uses a specific process to discharge the cold air in the
sterilizer room, and uses saturated humid and hot steam as a sterilization factor to
realize sterilization of articles that can be penetrated by steam under the
combined action of high temperature, high pressure and high humidity
environment and a certain temperature and time.
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TD-XT-D004-001 V2.19
7) Killing Microorganisms Category: Killing or removing all microorganisms on
medical devices, appliances and articles.
8) Special storage and transportation conditions and methods: None
9) Packing and transportation: in accordance with GB/T 191.
10) Production Date: See Equipment Nameplate.

Instructions

Keep the Manual completely within the service life of the equipment;

Ensure that all updates received can be saved in the Manual;

When the equipment using site or unit changes, the Manual must be
transferred or handed over as a part of the whole equipment.

Please learn more about the symbols posted on the machine in the following list:
SN Symbols Content Explanation
High temperature near symbol surface, be
1
careful of scalding
Note that please follow the detailed
2
instructions

3 Grounding identification

There is a dangerous voltage here. Please


4 cut off the power before operation or
maintenance.

In the Manual, the following symbols are used to indicate the operation
contents that should be paid attention to or highly valued:
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TD-XT-D004-001 V2.19

Great attention should be paid to it.

It should be observed or it will damage the equipment.

Strictly abide by it, otherwise his personal safety will be endangered.

Before carrying out any operation and maintenance on the equipment,


please carefully read and fully understand the contents in each chapter of this
Manual, especially those with the above marks should be paid attention to.

If the equipment is not used according to the methods specified by the


Company, the protection provided by the equipment may be damaged.

Instructions must be carefully kept to prevent loss or damage, even minor


damage should be avoided.

Operators are obliged to carry out technical repairs and complete some
contents, catalogues and relevant chapters lost, damaged or no longer applicable
in the Manual.

No one can tear or take out anything from the Manual under any
circumstances.
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TD-XT-D004-001 V2.19
In the process of learning and using the equipment, if the user
encounters any situation that does not conform to the instructions in
the Manual or is not covered in the Manual, please contact our
company in time, and we will answer for you in time. If necessary, the
Manual will be upgraded or updated free of charge.

The storage place of this Manual shall be kept ventilated and dry to
avoid humidity and high temperature.

This equipment is not suitable for sterilization of tightly sealed bottled


liquid. If you sterilize the above liquid, please contact our company and we will
select a special sterilizer for you.

When sterilizing tightly sealed bottled liquid with this equipment, bottle
explosion accidents are easy to occur due to negligence of operators or violation
of operating procedures, seriously endangering the safety of people and
equipment.

Chloride ion is an important factor causing corrosion damage to stainless

steel. If the sterilizer is used to sterilize articles containing chloride ions, the wall of

the sterilization room must be washed with clear water every day to avoid the

corrosion of the deposited chloride ions to the internal stainless steel and fully

prolong the service life of the equipment.

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TD-XT-D004-001 V2.19

If this sterilizer is used to sterilize articles containing chloride ions, but

the equipment is not cleaned every day as required, the service life of the

equipment will be seriously affected, and the additional damage and accelerated

aging caused to the equipment will not be covered by our company!

When symbols are seen anywhere on the equipment, it is


necessary to consult this manual and other relevant documents in order to
understand the nature of the potential hazards and any countermeasures that
must be taken.

When a symbol is seen anywhere on the equipment, it indicates

that the surrounding temperature is relatively high. Please pay attention to avoid

scalding.

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TD-XT-D004-001 V2.19

1. The user unit of this product shall carry out regular daily maintenance and
regular self-inspection during use.
2. The user unit of the product shall conduct self-inspection of the products
in use at least once a month and make records. If the user unit finds any abnormal
situation during self-inspection and daily maintenance of the in-use products, it
shall deal with it in a timely manner.
3. The user unit of the product shall regularly check and overhaul the safety
accessories (safety valves, pressure gauges, etc.), safety protection devices,
measurement and control devices and relevant ancillary instruments and meters
of the products in use, and make records.
4. The operators of this product and their relevant management personnel
shall, in accordance with the relevant provisions of the State, pass the examination
by the special equipment safety supervision and management department and
obtain the special operation personnel certificate in a unified national format
before engaging in the corresponding operation or management work.
The user unit shall educate and train the operators on the safety and energy
conservation of special equipment to ensure that the operators of special
equipment have the necessary knowledge on the safety and energy conservation
of special equipment. The operators of this product shall strictly implement the
operation procedures of special equipment and relevant safety rules and
regulations during the operation.

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TD-XT-D004-001 V2.19
1. This equipment meets the emission and immunity requirements specified in

GB/T 18268.

2. This equipment is designed and tested according to Class A equipment in GB


4824. In the home environment, this equipment may cause radio interference, and
protective measures need to be taken.
3. It is recommended to evaluate the electromagnetic environment before the
equipment is used.
4. It is forbidden to use this equipment beside strong radiation sources (such as
unshielded radio frequency sources), otherwise it may interfere with the normal
operation of the equipment.

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TD-XT-D004-001 V2.19
Contents
Chapter I Brief Introduction ---------------------------------------------------------------------------------------- 11 -
Chapter II Technical Parameters --------------------------------------------------------------------------------- 15 -
Chapter III Installation and Commissioning -------------------------------------------------------------------- 16 -
3.1 Unloading of Equipment ------------------------------------------------------------------------------------- - 16 -
3.2 Unpacking and Inspection ----------------------------------------------------------------------------------- - 16 -
3.3 Equipment Installation --------------------------------------------------------------------------------------- - 17 -
3.4 Equipment Commissioning ----------------------------------------------------------------------------------- 21 -
Chapter IV Structural Features and Working Principle --------------------------------------------------- - 24 -
4.1 Cabinet ----------------------------------------------------------------------------------------------------------- - 24 -
4.2 Cabinet Doors ---------------------------------------------------------------------------------------------------- 24 -
4.3 Pipeline System -------------------------------------------------------------------------------------------------- 30 -
4.4 Structure and Principle of Control System -------------------------------------------------------------- - 35 -
4.5 Working Principle of Control System --------------------------------------------------------------------- - 39 -
4.6 Exterior Decorative Panel ------------------------------------------------------------------------------------- 43 -
Chapter V Usage and Operation ------------------------------------------------------------------------------- - 43 -
5.1 Operation Instructions --------------------------------------------------------------------------------------- - 44 -
5.2 Parameter Setting: ---------------------------------------------------------------------------------------------- 49 -
5.3 Manual Operation --------------------------------------------------------------------------------------------- - 53 -
5.4 Program Operation -------------------------------------------------------------------------------------------- - 54 -
5.5 Precautions for Sterilization Operation ------------------------------------------------------------------ - 55 -
Chapter VI Troubleshooting ---------------------------------------------------------------------------------------- 57 -
6.1 Analysis and troubleshooting of common faults: ----------------------------------------------------- - 57 -
6.2 Analysis and Troubleshooting of Wet Package: -------------------------------------------------------- - 65 -
6.3 Analysis and elimination of unqualified sterilization: ------------------------------------------------ - 66 -
6.4 Problems that cannot be resolved: ----------------------------------------------------------------------- - 67 -
Chapter VII Troubleshooting ------------------------------------------------------------------------------------ - 68 -
7.1 How to check and replace the safety valve ------------------------------------------------------------- - 68 -
7.2 Procedures for Replacing Electric Heating Pipe --------------------------------------------------------- 68 -
7.3 Cleaning of solenoid valve ------------------------------------------------------------------------------------ 68 -
7.4 Cleaning of water inlet filter and drainage filter -------------------------------------------------------- 70 -
7.5 Replace the water level detection device --------------------------------------------------------------- - 70 -
7.6 Use and Maintenance of Origami Printer --------------------------------------------------------------- - 71 -
7.7 Components that are only allowed to be maintained and replaced by professionals -------- 73 -
Chapter VIII Maintenance --------------------------------------------------------------------------------------------- 76 -
8.1 Safety Instructions ---------------------------------------------------------------------------------------------- 76 -
8.2 Maintenance plan --------------------------------------------------------------------------------------------- - 79 -
8.3 Maintenance Guide ------------------------------------------------------------------------------------------- - 85 -
8.3.1Inspection of pressure vessels ------------------------------------------------------------------------ - 85 -
8.3.2 Calibrate safety valve and pressure gauge -------------------------------------------------------- - 85 -
8.3.3 Check the corresponding relationship between the chamber temperature and chamber
pressure ------------------------------------------------------------------------------------------------------------- 86 -
8.3.4 Check all pipes for leaks --------------------------------------------------------------------------------- 86 -
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TD-XT-D004-001 V2.19
8.3.5 Clean the chamber, guide rails and filters ---------------------------------------------------------- 86 -
8.3.6 Clean the grill --------------------------------------------------------------------------------------------- - 87 -
8.3.7 Clean equipment surface ------------------------------------------------------------------------------ - 87 -
8.3.8 Check equipment printing records or monitoring data ----------------------------------------- 87 -
8.3.9 Generator drain (built-in generator unit) ----------------------------------------------------------- 87 -
8.3.10 Check whether the energy supply meets the Manual requirements -------------------- - 88 -
8.3.11 Check and clean door gasket and door sealing groove -------------------------------------- - 88 -
8.3.12 Clean all filters on pipelines ------------------------------------------------------------------------- - 88 -
8.3.13 Check the grille running conditions, whether the docking is smooth, and the bolts are
loose (if any) ------------------------------------------------------------------------------------------------------ - 90 -
8.3.14 Check and clean maintenance space ------------------------------------------------------------- - 90 -
8.3.15 Check printer -------------------------------------------------------------------------------------------- - 90 -
8.3.16 Check whether the live wire, ground wire and neutral wire at the main power supply of
the equipment are fastened ----------------------------------------------------------------------------------- 90 -
8.3.17 Check the wiring and terminal protection of the strong electric parts such as the
heating tube ------------------------------------------------------------------------------------------------------ - 91 -
8.3.18 Cleaning and descaling of generator water level probe (or float) and level gauge
cylinder (for built-in generator equipment) --------------------------------------------------------------- 91 -
8.3.19 Clean generator drum and heating pipe (For built-in generator equipment) ----------- 92 -
8.3.20 Check whether the liquid level display glass tube of the generator is displayed
correctly, and check whether the sealing gasket of the liquid level gauge is leaking (For built-in
generator equipment) ----------------------------------------------------------------------------------------- - 92 -
8.3.21 Dust removal of electrical components and equipment valve sensors inside the
electrical box ----------------------------------------------------------------------------------------------------- - 93 -
8.3.22 Check the anti-dry protection device (For built-in generator equipment, if any) ------ 93 -
8.3.23 Check the safety valve for water leakage or steam leakage -------------------------------- - 94 -
8.3.24 Check the heating pipe for water leakage (For built-in generator equipment) --------- 94 -
8.3.25 Check whether all the wires of the equipment are damaged ------------------------------- 94 -
8.3.26 Check door safety, including all door position switches, barrier protection, and moving
parts ---------------------------------------------------------------------------------------------------------------- - 95 -
8.3.27 Check whether the generator upper pressure limit is within the specified range (For
built-in generator equipment) ------------------------------------------------------------------------------- - 95 -
8.3.28 Clean all traps (if any) on equipment and steam lines --------------------------------------- - 95 -
8.3.29 Check and tighten the check valve ---------------------------------------------------------------- - 96 -
8.3.30 Lubricate and check door moving parts ----------------------------------------------------------- 96 -
8.3.31 Check and descale pressure transmitter connections ----------------------------------------- 96 -
8.3.32 Check recent alarm records to find the cause and assess whether it is caused by
component failure ---------------------------------------------------------------------------------------------- - 96 -
8.3.33 Check the PT100 for water leakage, damage, bumps and wiring problems ------------- 97 -
8.3.34 Check the pressure transmitter for water leakage, damage, bumps and wiring problems- 97 -
8.3.35 Check the chamber temperature and record the temperature difference value ----- - 97 -
8.3.36 Regularly clean all water tanks --------------------------------------------------------------------- - 97 -
8.3.37 Check whether the equipment drainage pipeline is smooth -------------------------------- 97 -
8.3.38 Check whether the warning signs of the equipment are complete and the diagrams are
clear and easy to see ------------------------------------------------------------------------------------------- - 98 -
8.3.39 Check the Operating Procedures ------------------------------------------------------------------ - 98 -
8.3.40 Check the pressure safety interlock device ----------------------------------------------------- - 98 -
8.3.41 Check the front and rear door emergency stop switches (if any) ------------------------- - 98 -
8.3.42 Confirm that all signal lines are not crushed when opening and closing the door --- - 99 -
8.3.43 Confirm that all spare parts in the maintenance room are not affected by water vapor- 99 -
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TD-XT-D004-001 V2.19
8.3.44 Confirm that the wire slots and terminal guards are intact and there is no potential risk
of electric shock ------------------------------------------------------------------------------------------------- - 99 -
8.3.45 Check grounding impedance ------------------------------------------------------------------------- 99 -
8.3.46 Check whether the generator low level switch is effective --------------------------------- - 99 -
8.3.47 Check the integrity of equipment and external pipe insulation ------------------------- - 100 -
8.3.48 Check the level of front and rear door guides and fasten them ------------------------- - 100 -
8.3.49 Check and clean the steam baffle ----------------------------------------------------------------- 100 -
8.3.50 Check and clean all flow-limiting joints (if any) ---------------------------------------------- - 100 -
8.3.51 Check all valves for leaks --------------------------------------------------------------------------- - 100 -
8.3.52 Check if the key switch is in good contact ----------------------------------------------------- - 100 -
8.3.53 Calibrate the date and time ----------------------------------------------------------------------- - 101 -
8.3.54 Replace the door gasket ---------------------------------------------------------------------------- - 101 -
8.3.55 Detect temperature, pressure and time parameters --------------------------------------- - 102 -
8.3.56 Replace the generator water level gauge gasket (For built-in generator equipment)- 102 -
8.3.57 Replace all clamp gaskets on the pipeline ----------------------------------------------------- - 102 -
8.3.58 Replace the air filter element --------------------------------------------------------------------- - 102 -
8.3.59 Disassemble and clean bolt ------------------------------------------------------------------------- 103 -
8.3.60 Clean the printer thermal printer head -------------------------------------------------------- - 103 -
8.3.61 Check the integrity of the equipment nameplate ------------------------------------------- - 103 -
8.3.62 Calibrate the touch screen ------------------------------------------------------------------------- - 103 -
8.3.63 Replace PLC battery ----------------------------------------------------------------------------------- 106 -
8.3.64 Replace the heating tube contactor of generator (For built-in generator equipment)- 106 -
8.3.65 Leak test ------------------------------------------------------------------------------------------------ - 107 -
Run the leakage program, the program ends successfully and the leakage rate is not greater
than 0.13KPa/min. -------------------------------------------------------------------------------------------- - 107 -
8.3.66 Check and clean the working fluid inlet and cavitation protection port of vacuum pump,
check the suction of the pump, no leakage during operation ------------------------------------- - 107 -
8.3.67 Vacuum pump cleaning and descaling (if any) ------------------------------------------------- 107 -
8.3.68 Check the integrity and stability of the vacuum pump vibration damping pad ------- 108 -
8.3.69 Replace generator water level gauge gasket (For built-in generator equipment) ---- 108 -
Chapter IX Others ------------------------------------------------------------------------------------------------ - 109 -
8.1 Self-protection ------------------------------------------------------------------------------------------------ - 109 -
8.2 Guarantee of Sterilization Quality ----------------------------------------------------------------------- - 110 -
8.3 Detection of Sterilization Effect -------------------------------------------------------------------------- - 113 -
8.4 Energy Saving and Environmental Protection -------------------------------------------------------- - 120 -
Appendix ----------------------------------------------------------------------------------------------------------------- 121 -
Appendix A Operating Procedures --------------------------------------------------------------------------- - 121 -
Appendix B Electrical Drawing ---------------------------------------------------------------------------------- 121 -
Appendix C Installation Drawing ------------------------------------------------------------------------------ - 121 -
Appendix D Intensity of Sterilization Factors -------------------------------------------------------------- - 121 -
Applicable to XG1.UCD ---------------------------------------------------------------------------------------------- - 122 -

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TD-XT-D004-001 V2.19

Chapter I Brief Introduction


Pulse Vacuum Sterilizer uses humid and hot steam as sterilization factor. The
design life of the product is 8 years (or 16,000 sterilization cycles) (Note: This
design life is the failure period estimated according to the standard use
environment agreed by the equipment, and has nothing to do with the failure rate
occurring during the actual use of the equipment. Improper use will also
accelerate the damage of the equipment). In the design of the equipment, after
the cold air in the inner chamber is removed according to the specified
sterilization process, saturated humid and hot steam is used as the sterilization
factor to realize sterilization of articles that can be penetrated by steam under the
action of a certain time and pressure in a high temperature, high pressure and
high humidity environment. All default process parameters of this equipment are
determined under the load conditions described in this procedure, with
thermophilic fatty liver bacteria spores under specific resistance or
microorganisms with equivalent performance (see GB18281 and other relevant
national standards for details) as representatives of sterilizable microorganisms,
which can kill bacterial spores.
Note 1: When the resistance of microorganisms that may be infected by the
load to be sterilized is greater than the resistance agreed in the standard (e.g.
Microorganisms carried by mad cow disease pathogens), relevant process
parameters such as sterilization pressure and sterilization time need to be
adjusted according to the characteristics of specific microorganisms, and can only
be used after confirmation by corresponding processes.
Note 2: The killing ability of the sterilization factor to the agreed
microorganisms can effectively ensure the killing effect only when the equipment
and related facilities are in normal working conditions. For example, the failure of
the equipment, the failure of the external connection system, the loading and
- 11 -
TD-XT-D004-001 V2.19
placement of the sterilized load, etc. may interfere with the killing effect of the
sterilization factor.
Note 3: Due to the continuous updating and upgrading of the sterilized load,
the operator shall verify that the sterilized load is suitable for sterilization in this
equipment before carrying out relevant operations, otherwise unpredictable
damage may be caused to the equipment or load!

The standard equipment with the following order numbers is applicable to


this manual:
Equipment Volume Size of lumen (mm) Overall Net Power
Model Dimensions Weight
XG1. U 100L 400×850 (φ×L) 1250×730×1660 260kg 11kVA
XG1. U 135L 500×710 (φ×L) 1110×750×1742 400kg 11.5 kVA
XG1. U 185L 500×950 (φ×L) 1350×750×1742 460kg 11.5 kVA
XG1. U 300L 632×1000 (φ×L) 1415×890×1780 750kg 18kVA

 Sterilization working temperature:


 Design pressure:-0.1/0.25 Mpa
115 ~ 138 ℃
 Temperature display accuracy:
 Pressure display accuracy: 1Kpa
0.1 ℃
 Lower vacuum limit:-0.08 MPa

According to the order number, the volume of the equipment will vary. The
three types of equipment used in this manual are only different in volume and
power, and other parameters are the same.

This sterilizer is only suitable for sterilizing high temperature and


humidity resistant medical instruments and articles, and cannot be used for
sterilizing oils and powders such as Vaseline.
- 12 -
TD-XT-D004-001 V2.19

It is strictly prohibited to use this equipment to sterilize the sealed liquid


packaged in glass bottles or glassware, because the liquid bottles may burst due to
changes in operation or temperature and pressure, causing harm to people and
equipment.
 Sterilizer cabinet door adopts radial door bolt locking mechanism. The
sealing ring is made of silicone rubber with good temperature resistance
and elasticity. The door center is equipped with a pressure safety
interlock device-electromagnetic lock, which meets the requirements of
the "Regulations for Safety and Technical Supervision of Pressure Vessels"
issued by the State Bureau of Quality and Technical Supervision. Under
any circumstances, the handwheel can only be rotated when the pressure
in the inner chamber is within ± 10 KPa. The cabinet door is also equipped
with a closing travel switch. Only when the cabinet door is tightened can
the operation program be started. Therefore, the cabinet door has good
overall sealing performance, safety and reliability, and convenient
operation.
 The upper computer adopts a new type of liquid crystal display, which can
display graphics, dynamic text, dynamic display of working flow and
parameters such as time, temperature and pressure in the working
process, and can carry out special configuration according to needs.
 The lower computer adopts a modern new control device-programmable
controller (PC for short) for program control, which has the characteristics
of strong function, high reliability and flexible use.
 The air removal mode of mechanical forced pulsating vacuum is adopted,
and the cold point in the sterilization room is completely eliminated
- 13 -
TD-XT-D004-001 V2.19
through multiple vacuum and multiple steam injection, so that the air
removal amount reaches more than 99%, and the "dead angle" and
"small loading effect" of temperature are completely eliminated, thus
ensuring reliable sterilization effect.
 The sterilizer is divided into single door and double door (i.e. Single door
and double door). The double door sterilizer can effectively isolate the
bacteria-bearing area from the sterile area and meet the specification
requirements of the National Drug Production Management GMP.
 The main control parts and valve parts are all matched with world-famous
brand high-quality parts, which greatly improves the stability and
reliability of this kind of equipment.
 The service life of the equipment is 8 years (or 16,000 sterilization cycles).

The correct installation of sterilization equipment plays a very important


role in the normal performance of its equipment and must not be ignored.

- 14 -
TD-XT-D004-001 V2.19

Chapter II Technical Parameters


1. Rated working pressure: 0.205 MPa; Rated operating temperature: 132 ℃;
2. Setting range of pulsation times: 0 ~ 99 times;
3. Sterilization time setting range: 0 ~ 7200 seconds (2 hours);
4. Setting range of drying time: 0-7200 seconds (2 hours);
5. Pulsation amplitude setting: positive value 0MPa ~ 0.1 MPa, negative
value-0.1 MPa ~ 0MPa;
For other technical parameters, please refer to the equipment installation
drawing. If there is any change in parameters, the equipment installation drawing
shall prevail.
6. Pressure controller setting: upper switching value 0.24 MPa and lower
switching value 0.22 MPa
7. Water source: demineralized water with pressure of 0.15 ~ 0.3 MPa;
8. Power supply: 380V±38 V/50Hz±1 Hz (the power shall be subject to the order
number of the specific equipment);
9. Ambient temperature: 5 ℃ ~ 40 ℃;
10. Relative humidity: no more than 85%;
For other technical parameters, please refer to the equipment installation
drawing. If there is any change in parameters, the equipment installation drawing
shall prevail.

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TD-XT-D004-001 V2.19

Chapter III Installation and Commissioning

The correct installation of sterilization equipment will play an


important role in the normal performance of its equipment and must not be
ignored.

3.1 Unloading of Equipment

When the equipment arrives at the customer's place, attention should be paid
to:
 Do not stand under the hoisting equipment.
 Ensure that there is a sufficient safe distance around the hoisting
equipment.
 Qualified hoisting equipment shall be used.
 Adjust the hoisting equipment to find out the center of gravity so that the
equipment can be hoisted horizontally.
 During hoisting, attention should be paid to protecting the outer
packaging board.

3.2 Unpacking and Inspection

 After unpacking the equipment, first check whether the model and name
on the product nameplate are consistent with the order form. (The
product nameplate is on the side of the equipment)
 According to the details of the equipment packing list, carefully check
whether all parts of the equipment are in good condition, damaged or lost.
If so, make records and contact our company in time.
 Carefully check whether all connections or fixing parts are loose due to
- 16 -
TD-XT-D004-001 V2.19
long-distance transportation, and tighten if any.
 Check and record the accessories randomly carried by the equipment.

3.3 Equipment Installation

Before the equipment is installed, if necessary, we can provide our company


with the purchased equipment model so as to ask for the installation drawing.
During the installation process, professional construction personnel shall be
responsible under the guidance of professional personnel.

Non-standard installation will bring harm to human life and property


and hinder the normal and reliable operation of equipment.
Our company does not bear the consequences of non-standard
installation.
1. Preparation and requirements before installation
 Installation space: considering the operation and maintenance of the
equipment, the space height for installing the sterilizer should not be less
than 2.9 meters; The distance between the left and right sides of the
sterilizer and the wall shall not be less than 0.5 m; The depth of the
loading/unloading direction of the sterilizer shall not be less than 1.5
times of the length of the sterilizer, so as to facilitate the transportation of
sterilized articles. When installing a single-leaf sterilizer, the distance
between the non-operating end and the wall should also not be less than
0.5 meters.
 Foundation: The surface shall be firm and flat, and the load-bearing
capacity shall meet the corresponding equipment requirements. If it is
installed above the second floor, the user should consider whether the

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TD-XT-D004-001 V2.19
corresponding parts of the floor need to be reinforced according to the
specific situation.
 Ventilation and heat dissipation: In order to better ensure the normal
operation of the equipment and a comfortable working environment, it is
suggested that a suitable ventilation system should be installed in the
working room to control the ambient temperature and humidity around
the sterilizer.
 Drainage: A drainage pipe with a size at least one specification larger than
that of the drainage pipe outlet configured by the sterilizer shall be
selected, and the drainage pipe shall be led to the trench separately for
discharge outside, and shall not be communicated with other drainage
pipes in the building (such as cleaning, floor drain, etc.), otherwise some
gas discharged by the equipment during operation will affect other
rooms.

The drainage pipe shall be installed from high to low at the


drainage outlet of the equipment without back pressure,
otherwise the sterilization or drying effect will be affected
due to poor discharge of condensed water. When multiple
devices share a total drain pipe, the flow rate of the total
drain pipe shall be greater than the sum of the drain pipe
flows required by each device. Drainage pipe materials shall
be high temperature resistant (140 ℃), corrosion resistant
and aging resistant materials. When installing the equipment,
the anchor bolts should be adjusted to ensure that the drain
outlet of the main body is the lowest point.
 Water source: used for water ring vacuum pump and steam generator.
- 18 -
TD-XT-D004-001 V2.19
The interface size is 1/2 inch internal thread, the pressure requirement is
0.15 ~ 0.3 MPa, and the flow requirement is shown in the installation
drawing. During installation, a valve and a pressure gauge of 0 ~ 0.6 MPa
shall be connected in the middle of the water inlet pipe. (Note: If the
water source pressure is higher than 0.4 MPa, the measuring range of
the pressure gauge shall be correspondingly increased to ensure that the
pressure gauge works at 2/3 of the full measuring range.)

If the water source pressure is lower than 0.1 MPa, the vacuum
procedure cannot be started.

The steam generator carried by the equipment itself must use


demineralized water to generate steam.
 Power supply: Conventional equipment power supply AC380V shall be
three-phase five-wire system, three-phase live wire, one zero wire and
one ground wire. Among them, the zero line is blue, the ground wire is
yellow-green, and the three live wires are red, yellow and green. The load
capacity of the user's power supply and power cord should be greater
than the load of the equipment. It is required to install a power switch box
on the right or right rear wall of the sterilizer to ensure that the switch
box is located close to the equipment and easily accessible by operators.
The switch box shall be marked as special for the sterilizer. A three-phase
knife switch (or circuit breaker) and an overcurrent protection device
must be installed in the switch box to realize the functions of on-off and

- 19 -
TD-XT-D004-001 V2.19
overcurrent protection of the equipment power supply. Special
equipment shall be wired according to the actual contract requirements.
In order to ensure the safety of people and equipment, a ground wire
must be laid, and the ground wire in the equipment enclosure and
control cable must be reliably connected with the external ground wire.

Equipment and steam turbine enclosure must be strictly grounded!

The pipelines and lines shall be horizontally, horizontally, vertically and


effectively fixed.
Notes:
 Avoid installation in the environment of heavy dust, oil mist containing
conductive particles, corrosive gas and combustible gas.
 Avoid installation in situations prone to electric shock or vibration.
 Avoid installation in places with high temperature, high humidity or easy
to get wet by rain.
 Avoid installation in strong magnetic field environment.
2. Equipment in place
 Move the machine to the selected location. During the movement, care
should be taken not to damage or scratch the decorative covers. In case
of special circumstances, make records and marks, remove the pipeline
and outer cover, and restore the equipment as it is after it is in place.
 Take out the packaging bag, take out the random documents and keep
them properly.
 Attention should be paid not to scratch the original ground during handling.
3. Adjustment Level
The equipment can be directly placed on the horizontal ground. If it is
- 20 -
TD-XT-D004-001 V2.19
slightly uneven, it can be properly adjusted with thin iron sheets.
4. Connection of water, electricity and gas sources
According to the specific installation position and installation
requirements of the equipment, connect water, electricity and sterilizer with
each other. Sealing filler shall be used at the pipe joint to prevent leakage, and
no condensable liquid such as water source shall drip above the electrical
appliance box.

The power supply ground wire must be reliably grounded!

When installing equipment, please install leakage protection device


to prevent safety problems caused by component damage.

3.4 Equipment Commissioning

Some procedures have been preset according to relevant standards when


the equipment leaves the factory. During debugging, users can modify program
parameters according to usage requirements. Please read Chapter 5 "Usage and
Operation" for specific parameter settings.
 Before commissioning, check whether the wiring and socket of electrical
appliances fall off or loose, and tighten if there is one. Whether the
water inlet, drainage and connection are correct, otherwise adjust and
tighten.
 Open the inlet valve to ensure that the water source pressure meets the
requirements.
1) Vacuum pump rotation direction

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TD-XT-D004-001 V2.19
Turn on the power switch, log in with administrator or above authority,
enter the manual operation state, click the automatic/manual switch button,
and click B (vacuum pump) to start the vacuum pump at this time. Observe
whether the rotation direction of the vacuum pump motor fan is clockwise,
otherwise any two load lines on the three-phase load switch should be
switched.
Note: When performing this operation, if two people cooperate with each
other, the reversal time of the vacuum pump will be reduced.

2) Check each valve part

In the manual state, click the corresponding label of the solenoid valve
(F2 intake valve F3 evacuation valve F4 return valve F5 slow discharge valve
F6 water injection valve F7 pump valve), open the solenoid valve, and gently
approach the top of the solenoid valve with a screwdriver to feel strong
magnetic attraction.
3) No-load test
 Before running the program, the leak test shall be carried out according
to the instructions in Chapter 5 "Use and Operation". If the test fails,
there is leakage in the pipeline communicating with the inner chamber.
At this time, check carefully to eliminate leakage points and retest until
the test is qualified, otherwise the sterilization effect of the equipment
will be affected.
 Parameter Setting: refer to the working parameters of the program in
Chapter 5 "Usage and Operation" for setting.
 After the parameters are set, the routine operation of fabric, equipment
and BD experimental procedures can be carried out. Please read
Chapter 5 "Use and Operation" for the specific procedure process.
During the operation of the program, the tightness of the pipeline and
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TD-XT-D004-001 V2.19
the door shall be checked, and any steam leakage found in the pipeline
shall be handled in time.
4) Load Test
The above procedures are all carried out under no-load, and the load
test shall be carried out after the no-load test is completed. In the load
test, the load of non-liquid sterilized articles such as instruments and
fabrics shall not exceed 80% of the volume of the inner chamber, and
shall be placed on shelves, and each dressing bag and instrument bag
shall maintain a gap of 10mm. The load test must test the sterilization
effect of the inner center point of the package. According to the
introduction of Chapter 9, B-D test procedure, chemical test and
biological test are carried out on the sterilizer to observe whether the
test effect meets the requirements.

Allow the sterilizer to modify the program during


commissioning according to the actual situation.

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TD-XT-D004-001 V2.19
Chapter IV Structural Features and Working Principle
This product consists of cabinet body, cabinet door, shelf, pipeline system
and control system. Using saturated steam as medium, the effect of disinfection
and sterilization can be achieved under the condition of high temperature, and the
pulsation times can be set as required. See Appendix 3: General Assembly
Drawing.

4.1 Cabinet

 The exterior of XG1.UCD-100M cabinet adopts electric heating film to ensure


that the inner cabinet keeps a certain temperature to reduce condensation
of condensed water during internal sterilization.
 XG1.UCD-135M/185M/300M cabinet adopts double-layer jacket structure to
ensure that the inner cabinet keeps a certain temperature to reduce
condensation of condensed water during internal sterilization.
 The cabinet is made of imported stainless steel plates with excellent
corrosion resistance and is automatically welded by a special welder. The
surface is treated by mechanical polishing and electrochemical polishing. It is
bright, smooth and clean, corrosion resistant and durable.
 The cabinet body adopts high-quality thermal insulation materials on the
surface of the outer cabinet board, which is not only beautiful and durable,
but also can reduce the heat radiation of the equipment to a minimum and
effectively ensure the working environment of the equipment.

4.2 Cabinet Doors

The cabinet door of this series of sterilizers is mainly composed of door panel,
door bolt and locking mechanism, sealing ring, hinge plate, door cover, handwheel,
pressure safety interlocking system and control elements.
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TD-XT-D004-001 V2.19
1) Door-open Direction:
 The operating end is called the front door and the non-operating end is called
the rear door (only for double-door sterilizers). General configuration is that
the single door is left open, the double door is right open for the front door and
left open for the back door.
 If it is a device that needs to change the direction of opening the door
according to the user's requirements, some of its functions need to be
operated in reverse according to the following introduction.
2) Removal of door cover:
 First remove the logo in the middle of the handwheel, then unscrew the screw
in the center of the decorative cover with a cruciform screwdriver before
removing the handwheel seat. Then remove the screws on the upper left and
lower right of the door cover. At this time, hold the two sides of the door
cover with your hands, break it slightly outward and lift it upward. At this time,
the door cover can be removed.
3) Door bolt and locking mechanism:
The locking of the door is completed by manually driving the screw to rotate
through the revolving door handwheel so that the nine door bolts extend
outward.
When leaving the factory, each door bolt gasket has been adjusted. If air
leakage is found, users should not adjust it indiscriminately. The adjustment must
be carried out by professional personnel, otherwise the adjustment will get worse.
 Close the door
Before closing the door, each door bolt is in the fully contracted position,
i.e. The door handwheel turns counterclockwise to the limit position. Close the
door, make the handwheel rotate clockwise, the door bolt automatically extends
out and inserts into the front sealing plate, and then continue to rotate the
handwheel. When the operator hears the "click" sound of the door switch in the
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TD-XT-D004-001 V2.19
door cover being pressed, continue to rotate for half a circle to one circle to
completely press the handwheel.

It is strictly prohibited to rotate the handwheel clockwise when


opening the door to prevent the door bolt from extending
outward. Closing the door in this state will cause damage to the
equipment cover and cabinet door!

 Open the door


The door can be opened by turning the left hand wheel to the limit
position.

Note: The door will only open when the inner chamber pressure
is equal to the atmospheric pressure!

 Door switch
The door switch is installed in the door cover and acts by the pressure of the
door bolt. The front and rear doors of the double-leaf cabinet each have a door
switch. The program can only be started after the current rear door is tightly
closed. If the door is not tightly closed, the program cannot be started, thus
avoiding the phenomenon of starting the machine without the cabinet door being
tightly closed. In case of special circumstances, the pressure plate on the door bolt
can be adjusted to adjust the sequence of door opening and closing actions.
4) Pressure safety interlock:
 The cabinet door is equipped with double safety. A travel switch is installed at
the lower left of the door panel. The switch is pressed down before the door is
locked to turn on the program control circuit of the equipment. That is to say,
the cabinet door is not locked and the program cannot be started. When the
program is started, the electromagnetic lock pops up (both the front and rear
doors of the double-leaf series pop up). At this time, the handwheel cannot
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TD-XT-D004-001 V2.19
rotate and the door cannot be opened. When the sterilization procedure is
completed and the inner chamber pressure drops to less than ± 10 KPa, the
electromagnetic lock is retracted and the door can be opened.
5) Post-Haff
For manual doors that are used for two years or more, some of them will
have serious consequences of long-term abrasion of the rear Haff two positioning
pins and cam spiral grooves, especially at the rear Haff two positioning pins, which
will cause them to break from the root in serious cases and the doors cannot be
used normally. Most of the above phenomena are related to the operator: if the
cabinet door is not in a good position and is forced to close the door, the part will
be severely worn if the force is too large, and serious wear will lead to the cabinet
door being completely unusable. Therefore, the opening and closing force should
be moderate to prevent damage to transmission components.
6) Sealing ring
 Structure: Sealing ring is a specially processed annular silicone rubber ring. Its
material composition, shape design, correct installation and maintenance are
crucial to its normal work and service life. The sealing ring used by our
company adopts a special formula of silicone rubber material, which
effectively ensures its stability and reliability in high temperature working
environment.
 Principle: The sealing ring is fixed on the sealing ring seat of the main body.
When the cabinet door is closed, the sealing ring is tightly attached to the
sealing plate in front of the end of the cabinet body under the action of
external force. Due to the ladder shape of its sealing surface, certain
deformation will occur in the sealing process to realize the sealing of the door.
 Maintenance: Although the long-term use of the sealing ring has been fully
considered in the design and material selection, the following factors may
affect the service life of the sealing ring. These factors should be avoided as
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TD-XT-D004-001 V2.19
much as possible to ensure the longer service life of the sealing ring.
a. At the end of one shift, the main steam control valve entering the
sterilizer shall be closed in time to keep the cabinet door in the open
position, otherwise the sealing ring will gradually age due to high
temperature and pressure for a long time.
b. After half a year to one year of use, the sealing ring should be removed,
gently scrubbed with alcohol, dried and installed back to the end surface
of the cabinet door panel together with the sealing bead.
c. During operation, attention should be paid to prevent hard objects from
colliding with the sealing ring, otherwise it is easy to cause permanent
damage to the sealing ring, thus reliable sealing cannot be realized.
d. In the process of use, regular scrubbing of the surface of the sealing ring
and door panel will prolong the service life of the sealing ring.
 Failure: It can basically be determined that the sealing ring has failed when
the following reasons occur.
a. The surface of the sealing ring is obviously hardened, and when pulled, it
feels that it has lost its elasticity and has mesh lines.
b. The sealing ring is cracked or has broken.

Note: The judgment of whether the sealing ring fails or not should
be considered comprehensively, which has a great relationship with
the long-term accumulation of operators' experience.

 Remove and install:


When taking out the sealing ring, stop all programs to open the door and take
out the rubber strip from the sealing groove of the ring seat.
During installation, the sealing bead can be squeezed into the sealing groove
again. Note: Because the perimeter of the general sealant strip is a little more than
the perimeter of the sealing groove, the excess length should be evenly distributed
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TD-XT-D004-001 V2.19
in the sealing groove during installation.
Note: When installing the sealing ring, it can be easier to install it
with the help of another person!

7) Troubleshooting: (See Table 1)


Table 1: Troubleshooting Table of Cabinet Door 1

Fault phenomenon Cause Analysis Solutions

1. After the indoor pressure


1. There is pressure in the
returns to zero, open the door
inner chamber
again.
2. The program is running
Step 2 Exit the sterilization
3. The temperature of the
procedure
1. The cabinet door inner chamber is higher
3. Wait for cooling to within the
cannot open. than the set temperature
temperature range before
for opening the door.
opening the door.
4. Electromagnetic lock
4. Check the electromagnetic
failure
lock and its connection

1. The position of the 1. Adjust the position of the


cabinet door changes and cabinet door relative to the
the door sags. front sealing plate
2. Door bolts are not fully 2. Turn the handwheel so that
2. The cabinet door retracted the door bolt is fully retracted.
cannot close 3. Damage to the drive 3. Check the drive system inside
completely. system inside the door the door
4. A certain door bolt 4. It is necessary to adjust the
cannot protrude position of the door bolt frame
against the front or the height of the gasket.
sealing plate.

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TD-XT-D004-001 V2.19
3. Steam leaks around 1. Wear or aging of door 1. Replace the door sealing ring
the door during sealing ring 2. Clean the pressing position of
operation. 2. There is dirt in the the rubber strip on the door
pressing place of the panel
rubber strip on the 3. Adjust the cabinet door
door panel. position again after the
3. The cabinet door is not chamber is deflated
closed tightly. 4. Adjust the height of the door
4. Uneven stress on door bolt frame gasket
bolt

4.3 Pipeline System

1) Jacket steam inlet pipeline


Equipment that produces steam by its own steam generator, Steam is generated
by heating demineralized water in the steam generator. The outlet of the upper
part of the steam generator is connected with the interface of the lower part of
the sterilizer cabinet body, and the generated steam enters the jacket through the
interface. The jacket steam can effectively isolate the influence of external cold air
on the inner chamber, and can also maintain the temperature of the inner
chamber to reduce condensation of the steam in the inner chamber.
 The steam generator is designed to give full play to its best performance
and has chosen the following optimal configuration:
a. The body of the device is made of high-quality seamless steel pipes
and carbon steel plates for pressure vessels, which are welded under the
protection of carbon dioxide flux-cored wire. The weld quality is good
and the overall strength is high.
b. The electric heating pipe is made of stainless steel pipe, which has
the characteristics of small volume and long service life.
c. The high-quality temperature-resistant high-pressure pump is
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TD-XT-D004-001 V2.19

selected for the water adding pump, which has the characteristics of small
volume, high outlet pressure and reliable operation.
d. The liquid level is controlled by the upper, middle and lower probes,
and the liquid level of each working stage is displayed through the glass tube
water level gauge on the outer decorative cover.
 The steam generator can realize the following automatic control
functions:
a Automatic water adding function: During the working process, the
water level in the steam generator body drops due to the continuous
output of steam. When it is lower than the high water level for three
minutes, the water adding pump will automatically start to replenish
water to the normal working water level (upper water level); When
the water level rises to the normal working water level, the water
addition pump is closed to stop water inflow so that it can
continuously supply steam to the equipment. In the sterilization stage,
when the water level reaches the low water level, water
replenishment is started.
b Automatic pressure control function: when the steam pressure in the
evaporator reaches the upper limit set by the pressure controller, the
heating power supply can be automatically cut off; When the steam
pressure in the evaporator decreases to the set lower limit, the
heating power supply can be automatically turned on to ensure that
the steam is output at a basically constant pressure.
c Automatic protection function for water shortage: When the water
level in the device body drops to the lower water level due to
unexpected reasons, the heating power supply can be automatically
cut off to ensure that the electric heating pipe will not be damaged

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TD-XT-D004-001 V2.19

due to dry burning due to water shortage.


d Overpressure automatic protection function: When the pressure in
the body exceeds the upper pressure limit set by the safety valve due
to unexpected reasons, the safety valve can be effectively and timely
released to protect the safety of equipment and operators.
2) Chamber steam inlet pipeline
The jacket steam enters the inner chamber through the inner chamber intake
valve F2 to disinfect and sterilize the articles.
3) Vacuum pumping line
The pipeline passes the air, steam and condensed water in the inner
chamber through the steam outlet at the lower part of the inner chamber, passes
through the vacuum valve F3, enters the vacuum pump, and is discharged through
the pump outlet.
 Vacuum valve F3: This valve is controlled by the execution program to open or
close.
 Vacuum pump: This pump is a water ring vacuum pump and is the main
equipment for vacuum. It uses clean water as working fluid. During the
working process of the pump, the working fluid will form a water ring around
the blades. The water ring plays a role of sealing and heat conversion, so it
should be continuously supplemented during the working process.
Note: The limit vacuum degree of the water ring vacuum pump is directly
related to the temperature of the water ring and the compression capacity of the
pump. The lower the water temperature, the higher the limit vacuum degree.
Therefore, the lower the water supply temperature of the pump, the better, with a
maximum of not more than 25 ℃.
4) Drain Pipeline
In the drain pipeline of the inner chamber, the condensed water generated by
the steam of the inner chamber passes through the steam outlet at the front and
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TD-XT-D004-001 V2.19
lower part of the inner chamber, passes through the filter, 1/4 solenoid valve, 1/4
ball valve and single valve to the drain outlet, and automatically discharges the
condensed water in the inner chamber.
One-way valve: It is a valve that only allows one-way flow of medium. One is
installed on the door evacuation pipeline and one on the inner chamber drain
pipeline respectively. The common faults are spring failure, sealing rubber pad
rupture or nut loosening and falling off, which is manifested as water inflow from
the sealing groove or steam return from the inner chamber. The valve is a
straight-through check valve to prevent external steam or water from returning to
the inner chamber and affect the working performance of the equipment.
5) Upper drain line
The upper air discharge pipeline of the inner chamber, and the steam
generated in the inner chamber passes through the steam discharge water port at
the front and lower part of the inner chamber to the water discharge port through
the filter, 1/2 solenoid valve and single valve to remove the steam from the inner
chamber. Only when the pressure of the inner chamber drops below 30KPa can
the vacuum operation be carried out.
The upper drain pipeline and the drain pipeline share the same solenoid
valve.
6) Air inlet line
After the impurities and bacteria are filtered out by the sterilization filter, the
air enters the inner chamber through the air return solenoid valve F4, so as to
eliminate the negative pressure formed at the later stage of work, the air is dry
and sterile, and the secondary pollution of the sterilized articles is prevented.
 Air filter: The air filter is cylindrical and uses high-precision medical filter
paper with a filtering accuracy of 0.22 m, which can filter out bacteria and
impurities in the air.
7) Water supply pipeline
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TD-XT-D004-001 V2.19
 Water supply pipeline: purified water enters the evaporator through the filter,
the inlet solenoid valve and the water injection pump F6, and tap water enters
the vacuum pump through the F7 pump valve for circulation. Filter: The filter
can effectively prevent and precipitate solid sundries carried by the water
delivery pipeline into the barrel-shaped filter screen to prevent them from
entering the equipment.
8) Pressure control line
This series of equipment is equipped with pressure controller, pressure
transmitter, platinum thermal resistor, interlayer and inner chamber pressure
gauge and other accessories.
 Pressure controller: The pressure controller controls the working pressure of
the evaporator within a certain range. The adjusting nut at the upper part of
the controller can adjust the size of the set pressure value, which can be
adjusted clockwise and counterclockwise. The right side adjusting nut of the
controller can adjust the difference between the upper and lower limits of the
set pressure value, which can be increased clockwise and decreased
counterclockwise.

The pressure controller has been adjusted when the product leaves
the factory. If adjustment is needed, it should be carried out by personnel with
work license.
 Pressure Transmitter: Please refer to the Structural Principle Section of the
Control System.
 Platinum thermal resistance: also known as PT100, please refer to the
structural principle section of the control system.
 Safety valve: The evaporator and the inner chamber are equipped with safety
valves respectively, which play the final role of safety protection when
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TD-XT-D004-001 V2.19
improper operation or abnormal pressure of equipment occurs. When the
pressure is higher than its upper limit set value, it will automatically open and
reduce the pressure. When it is lower than the lower limit setting value, it will
automatically close.
 Pressure gauge: For single-leaf sterilizer, two pressure gauges are installed at
the front door control end, one showing evaporator pressure and the other
showing inner chamber pressure. In the case of a double-leaf sterilizer, the
rear end is also equipped with the same pressure gauge indicating the
pressure of the inner chamber as the front end.

4.4 Structure and Principle of Control System

The control system consists of a main controller, a display, a micro thermal


printer, an electromagnetic valve, a pressure controller, a pressure transmitter, an
indicator lamp and a display instrument.
1) Front panel
The front panel is installed at the upper end of the front cover of the
equipment and contains a display, a printer and a key switch.
 Display: UCD-T57 display with the following features
a) Display graphics, dynamic text
b) Full touch operation, simple and convenient
c) Excellent communication function
 Printer: Micro power consumption, micro volume, panel installation and high
quality printing are the primary characteristics of this printer. Function: This
printer can record the working start time, operation times, operator number,
program nature, program setting parameters and pressure and temperature
values at the same time during program operation. The printing interval can
be set by the user himself.

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TD-XT-D004-001 V2.19
2) Rear panel
 The rear control is only applicable to the double-leaf sterilizer. It is equipped
with five indicator lights and one inner chamber pressure gauge. The indicator
lights run (green), the door is closed (yellow), the door lock (yellow), the alarm
(red) and the end (green).
3) Main control box
 Main controller: Powerful function, the main control part of the controller is a
highly integrated chip produced in the United States, with reliable
performance; Logic judgment, floating-point number operation, data storage,
communication networking and other performances are better than
traditional PLC control. It is a general industrial device integrating
microcomputer technology, automation technology and communication
technology. It is cost-effective and convenient to use, and has been widely
used in various neighborhoods of industrial control. It works according to
pre-input programs, receives and processes various input and output signals,
and controls the process of sterilization programs. The allowable range of
power supply voltage is 24VDC; Its working environment is 0 ℃ ~ 55 ℃.
The equivalent circuit of the controller consists of four parts:
A. Input part: receiving operation instructions or receiving various state
information of the controlled object; Control the process and conversion of
program flow.
B. Control part: This part is the control program compiled by the user, and
the control program is placed in the ROM of the controller. When the system is
running, the controller reads the program storage area in turn, interprets and
executes their contents, and sends the instructions that need to be output to the
output terminal of the controller to control the external load.
C Output part: drive the load directly or through the intermediate relay
according to the execution of the program.
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TD-XT-D004-001 V2.19
D. Analog conversion part: 5 analog inputs with 12-bit conversion accuracy;
The input standard current signal is converted into a digital signal, which is
converted into different quantities according to the definition of the program. In
this control, it is converted into temperature and pressure.

The inner wire of the control box must be reliably grounded, otherwise
there will be temperature and pressure jump! !
 Buzzer: When misoperation occurs or the sterilization program is abnormal,
the buzzer will sound an alarm sound to prompt. When sterilization is
completed, the buzzer will also prompt.
 Indicator light: (double-door equipment) There are five indicator lights, from
top to bottom are door closing light, door locking light, running light, alarm
light and end light. When the loading door and the unloading door are closed
at the same time, the door closing lamp is on, and when the electromagnetic
locks of the loading door and the unloading door are locked at the same time,
the door locking lamp is on.
 Safety seat: The safety seat is equipped with a fuse, which is the protective
umbrella of the control system to prevent excessive current from damaging
electrical components. Equipped with cylindrical cap fuse.
 Vacuum pump contactor: PLC outputs signals to the vacuum pump contactor
coil. The contactor coil is electrically closed, providing three-phase 380V AC
power supply to the pump, and the pump starts to operate.
 Pipeline pump relay: PLC outputs signals to the relay coil of the pipeline pump.
The relay coil is powered on and closed to provide 220V power supply to the
pump. The pump starts to operate and starts to enter water (if it is used for
the first time and the water source is not under pressure or the pressure is low,
water diversion shall be added in advance).
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TD-XT-D004-001 V2.19
 Heating tube contactor: PLC outputs signals to the contactor coil of the
heating tube. The contactor coil is electrically closed, providing a three-phase
380V AC power supply to the heating tube. The heating tube is electrically
powered and starts heating.
 Heating film contactor (only applicable to equipment of 100L and below): PLC
outputs signals to the heating film contactor coil, the contactor coil is
electrically closed, AV 220V AC power supply is provided to the heating pipe,
the heating film is electrically supplied, and heating starts.
4) Solenoid valve: The control system outputs a signal to the solenoid valve, so
that the coil of the solenoid valve is electrically sucked on and the pipelines at
both ends of the solenoid valve are connected. After the coil is powered off, the
valve is closed.
5) pressure control:
 When the evaporator pressure reaches the upper limit of its set value,
close the contactor for heating.
 When the evaporator pressure is lower than the lower limit of its set value,
open the contactor for heating.
6) Pressure transmitter: The inner chamber pressure signal is converted into a
current signal of 4 ~ 20mA, and then converted into a digital signal through
the module, which is reflected in the touch screen to be the actual inner
chamber pressure value.
7) Platinum thermal resistance:
 Working principle: Within a certain range, the resistance of PT100 is linearly
proportional to temperature. As the temperature rises, the resistance value
increases. The temperature decreases and the resistance value decreases. At
normal temperature (20 degrees Celsius), the resistance value of PT100
platinum resistor is 107.79 ohms. The thermoelectric resistance value of
PT100 is sent to the temperature transmitter, which is then transmitted to the
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TD-XT-D004-001 V2.19
analog module by the temperature transmitter. After conversion, the PT100 is
sent to the touch screen to display its actual temperature value.
 Installation and use: Platinum thermal resistor is installed at the lower exhaust
port of the chamber and cannot contact with pipe wall and accumulated
water. The connection shall be firmly fixed to the terminal.
8) Pressure gauge: Refer to the Piping System section.

4.5 Working Principle of Control System

The control system uses a high-integration chip as the main control chip and a
touch screen display as the man-machine interface. In the control, the analog
quantity standard module is used for collecting temperature and pressure signals:
the temperature measuring probe PT100 sends the resistance value signal to the
controller and converts it into an acceptable digital quantity; The pressure
transmitter for pressure measurement converts the pressure signal into a standard
4-20mA current signal, which is processed into a unit of quantities. The advantage
of analog control is that the programmable controller can timely detect the
continuous change of temperature and pressure during sterilization and display it
on the man-machine interface.
Before work, all instrument parameters must be adjusted and preset
according to the sterilization requirements of the sterilized articles, and the
corresponding sterilization procedures and working methods must be selected.
Please refer to Chapter 5 "Usage and Operation" for specific parameter settings.
1) Start up
Open the three-phase knife switch (or circuit breaker) in the power switch
box, then open the switch (key switch) on the front panel of the equipment, turn
the switch to the "On" position, and the switch is closed. The 220VAC power
supply supplies power to the controller and the standard power supply (for +

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TD-XT-D004-001 V2.19
5V/24VDC) in the control box through fuses, and the standard power supply
supplies power to the touch screen and printer. When the power supply is turned
on, the indicator light of PLC in the control box is on, the indicator light of standard
switching power supply is on, the initial picture is displayed after the touch screen
is self-checked, and the indicator light of the printer is on, all of which are in
standby state.
2) Door control
First, turn on the power switch. For XG1. UCD pulse vacuum sterilizer, turn
the door handwheel after closing the door, and rotate it for 1-1.5 turns after the
door bolt is in place. After the door travel switch is closed, the input signal
returned to the PC will enter the standby state when the front door display screen
shows the door closing state and the rear door indicator light shows that the door
state input has signals.
The front and rear door switches of the sterilizer are controlled by whether
the sterilization program is running, the temperature of the inner chamber and
whether there is pressure in the inner chamber, so as to ensure the safety of
equipment and operators. For the double-door sterilizer, the isolation between the
contaminated area and the sterile area can be effectively ensured. In standby state
or at the end of the process, when the front door (back door) is opened, the
electromagnetic lock of the back door (front door) pops open to lock the door to
achieve the effect of isolation.
Note: If it is a single door (single door) sterilizer, there is no rear door
indication.
3) Evaporator control
The system is powered on. After self-checking, the main controller is in
working state. If the low water level is not reached for water injection, the water
level is heated after reaching and then the pressure of the evaporator is
automatically maintained within a certain range.
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TD-XT-D004-001 V2.19
If there is an jacket, the equipment jacket and the evaporator are connected.
When the pressure reaches the upper limit of the evaporator pressure, the main
heating stops heating, and when the evaporator pressure drops to the lower limit
of the pressure controller for a period of time, the main heating starts heating
again, thus circulating.
During the operation of the program (non-sterilization phase), if the water
level is lower than the high water level for 3 minutes, the water injection pump
(valve) will be opened for water injection, thus keeping the water level in the
evaporator at the upper water level.
4) Steam inlet control in the chamber
After the key switch is powered on, each signal is processed by PLC, and the
intake valve is switched and controlled according to the flow requirements.
5) Evacuation of the chamber
In the programs of "fabric", "instrument" and "BD", the chamber should be
evacuated three times during pulsation to make the chamber close to vacuum so
as to enhance the penetration ability of steam. After running the program, the
pulsation stage is entered first after the preparation is completed, and the air in
the chamber is pumped out by the vacuum pump through the evacuation valve.
When the chamber pressure reaches the lower limit of pulsation, the evacuation
valve F3 is closed to stop evacuation. When the chamber pressure reaches the
upper limit of pulsation, the exhaust valve F0 opens, and when the chamber
pressure drops to the evacuation turning pressure (default 30kPa), vacuum starts
again. This cycle is repeated until the set number of pulsations is reached. After
the pulsation is over, the evacuation valve F3 is closed and the vacuum pump stops
running.
Causes of pulsation for three times: in general, the upper limit of pulsation
is 80kPa, the lower limit of pulsation is-80kPa, evacuation is once, and the
discharge is 80%; When evacuated twice, the discharge rate is 96%; When
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TD-XT-D004-001 V2.19
evacuated three times, the theoretical value of discharge can reach 99.2%, so
multiple pulsation vacuum effect is better, and the system pulsation setting can
reach 99 times at most.
6) Steam exhaust from the chamber
 Exhaust Control in Non-Liquid Programs
After the sterilization phase is completed, the program is transferred to the
exhaust phase. First, open the chamber exhaust valve F0 and start exhaust. When
the pressure in the chamber drops to the evacuation turning pressure, the pump
water valve F7 is opened, the evacuation valve F3 is opened, the vacuum pump
starts to operate, and the exhaust speed is accelerated.
 Liquid program exhaust
In the liquid program, after the sterilization process is completed, the slow
drain trap F5 is intermittently opened, and the steam in the chamber is slowly
discharged through the slow drain trap, forcing the pressure in the chamber to
slowly drop, thus preventing the liquid from overflowing through excessive boiling.
7) Dry stage
Due to the different properties of articles, when the drying stage is needed in
vacuum programs such as instruments, fabrics and BD, when the pressure in the
inner chamber drops to the exhaust zero position, the program shifts to the drying
stage. The pump water valve and evacuation valve are opened, and the vacuum
pump is operated to evacuate and dry. When the drying time arrives, the
evacuation valve, pump water valve and vacuum pump stop running and the
drying process ends.
8) Program End
In the programs of fabrics, instruments, BD, etc., when the drying time is up,
the air valve F4 is opened, the air inlet pipeline of the chamber is unblocked, air
inlet is started, and the pressure of the chamber is restored. When the pressure of
the chamber reaches the zero position of empty return, the program is delayed
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TD-XT-D004-001 V2.19
and turned to an end.

4.6 Exterior Decorative Panel

All exterior decorative plates of this equipment are routinely sprayed with
carbon steel (stainless steel can be customized), with beautiful appearance and
convenient disassembly and assembly. During the use of the equipment, if
necessary, the two buckles in the middle of the exterior decorative panel on the
left and right can be lifted, and the outer trim side cover can be removed by lifting
up.

Chapter V Usage and Operation


After the sterilizer can be used normally according to Chapter 3 "Installation
and Commissioning", turn on the total control power supply and water source of
the equipment, turn the key switch of the operation end to the "ON" side, and the
system starts self-inspection when powered on. The initial picture will appear on
the text display during the self-inspection process.
* Special Tip: When the control system is abnormal, you can judge whether the
control system is really abnormal or disturbed by power failure and restart.

Fig. 1 Fig. 2
In the initial screen, the above picture shows the two indicating states of door
closing and door lock respectively.
In the starting screen, the upper end of the display screen displays the
pressure and temperature of the inner chamber, and the temperature of the pan
wall will also be displayed if the heating film is used for heat preservation. The
units are kPa and ℃ respectively; The second line of information shows the
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TD-XT-D004-001 V2.19
current time; The lower left corner displays the display screen program model and
PLC program model, and the lower right corner is the login button.

After the sterilization of the liquid bottle is completed, when the


temperature of the inner cabinet drops below 80 ℃ (in areas below 1000
meters above sea level) and the pressure of the inner chamber drops to zero,
open the cabinet door to a gap of about 10mm and wait for about 10 minutes,
then open the large cabinet door and take out the liquid bottle. When using
liquid sterilization, the operating procedures must be observed!

5.1 Operation Instructions

 Description of key parameters of sterilization program:


Sterilization temperature and sterilization time are the key parameters that
affect the sterilization process. During the sterilization process, the control system
controls the lower limit of the sterilization temperature range in the sterilization
room to be the set sterilization temperature and the upper limit to be the set
sterilization temperature +3 ℃. The combination of default sterilization
temperature and time for this control system is shown in the following table.
When non-recommended loads, non-recommended packages, or other
combinations of sterilization temperatures and times are selected, relevant
sterilization process verification is required before use.
Note: When the load, packaging and sterilization temperature are the same, it
is considered that the sterilization effect with longer sterilization time is better
than that with shorter sterilization time, and only the shortest sterilization time
required can be verified.
SN Program 134 ℃ pulse vacuum program 121 ℃ pulse vacuum program

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TD-XT-D004-001 V2.19
1 Sterilize 134 ℃ 121 ℃
Temp.
2 Sterilize time 5 minutes 20 minutes
3 Overview of Withstand high vacuum and high Withstand high vacuum and low
the scope of temperature tolerance, such as temperature tolerance, such as
application instruments and dressings. rubber.
of articles

Note: The setting of each program parameter shall be corrected according to


the specific situation or its own sterilization process during use. After the
correction is completed, it shall be verified to be qualified, and finally the
biological test shall be fully qualified before use.
This control system has compiled 13 sets of programs as shown in the
following table. You can choose the application as needed. The following is an
introduction to the operation flow of each program and the setting of working
parameters.
Program Sterilization Sterilization
SN Drying time (S) Pulse count
Type Temp.(℃) time (S)
1# Fabric 132 600 480 3
2# Instrument 132 600 480 3
3# Rubber 121 1200 480 3
4# Fast 134 210 210 1
5# Liquid 121 1200 --- 0
6# Preheating 121 210 210 1
7# Custom 1 132 600 480 3
8# Custom 2 132 600 480 3
9# Lumen 132 600 480 3
10 # BD 134 210 480 3

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TD-XT-D004-001 V2.19
11 # PCD 134 210 480 3
12 # Leak Vacuum test procedure: hold phase 300s, test phase 900s
13 # Dry None 0 900 0
Table 1
Note: In the program (especially the fast program), if the temperature cannot rise
(less than 2 ℃ lower than the sterilize temperature), the upper limit of the
chamber pressure can be modified in Fig. 8 to increase the pressure (generally
10KPa, about 1 ℃ higher)
(1) Screen operation:
If the equipment uses jacket insulation mode, the boiler wall temperature will
no longer be displayed in the operation screen.
After entering the startup screen, click Login to enter the login selection
screen:

Fig. 3 Fig. 4
There are administrators, craftsmen and eight operators. The
administrator password and craftsman password are 149. The operator
has no initial password. The operator or administrator and craftsman can
set the operator password. The authority of technician is higher than that
of operator, and that of administrator is higher than that of technician.
The service personnel shall be logged in by the manufacturer's service
personnel.

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TD-XT-D004-001 V2.19

Fig. 5 Fig. 6
Figures 4-6 show the login images of operator, supervisor and
administrator respectively.
(2) Parameter settings after logging in with different permissions:
 Operator: The operator has no password by default and can log in directly.
The operator can change the operator's password, for example, logging in
to Operator 1, then the password changed under the logging in of Operator
1 is the new logging in password of Operator 1, and the operator can only
select and start the program.
 Supervisor: The supervisor can change the password of the supervisor.
After logging in, the supervisor enters the program selection screen Fig.10.
After selecting the program, click Edit to enter the Fig 7. The process can
modify some parameters of the sterilization process as shown in Fig 7 and
8. The sterilization temperature, pulse count, sterilize temperature,
chamber pressure limit (upper limit), cooling temperature and drying time
can be changed. The stage configuration in Fig.7 belongs to the standard
configuration of the device and does not need to be set up.

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TD-XT-D004-001 V2.19

Fig. 7 Fig. 8
 Administrator: On top of the supervisor's authority, some parameters of
the program can be set. The system parameter settings are shown in Fig. 9
below. Parameters can be set for printing: printing time interval, whether
F0 is printed, whether Chinese and English are printed, whether to print,
and whether to print reports. Print trends are not standard for devices.
Administrator permissions can change administrator, supervisor, and
operator passwords (trend chart printing is not currently supported).

Fig. 9 Fig.10
(3) Program selection and startup
Select program startup or program setting to enter the startup screen, as
shown in Figure 11. When logging in as an administrator or technician, you
can click the Edit button to set some sterilization parameters, as shown in
Parameter Setting. Click the start program to enter the start parameter screen,
as shown in Fig. 11. Click the start button to start the program.

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TD-XT-D004-001 V2.19

Fig. 11 Fig.12
(6) If the atmospheric pressure in the area where the user is located is not a
standard atmospheric pressure, please contact the service personnel to set the
relevant parameters and adjust the exhaust zero position and the return zero
position.
(4) System Maintenance: After logging in with administrator rights, click the
System Maintenance button to enter Figure 12 of the Time Setting screen. After
modifying the time, click Time Save to return. MAC and IP do not need to be set
up. When the equipment is monitored by the microcomputer, MAC and IP need to
be set up, which is not the standard configuration of the equipment.

5.2 Parameter Setting:

1) Program parameter settings:


When entering Fig. 7 and 8 above the supervisor's authority, the sterilization
parameters of the program can be modified:
The setting range is as follows:
Replacement time: set range [0 7200], default liquid program has replacement
phase 300s
Pulse times: set range [0 99], defaults to 3 times
Sterilization temperature: set range [0 150], default 132 ℃/134 ℃
Sterilization time: setting range [0 7200], which varies according to different

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TD-XT-D004-001 V2.19
loads
Cooling temperature: set range [50 130], default 105 ℃ (except liquid)
Drying time: setting range [0 7200], which varies according to different loads
Chamber pressure limit: set the range [0 300] and set the corresponding value
according to different sterilization temperatures.
Vacuum pump mode: In the pulsating phase, whether the vacuum pump will
continue to work (the evacuation valve is closed) after the vacuum is finished
and the air intake is started can be intermittent or normally open. Default
break. This item is set to protect the vacuum pump.
Replacement time: the heating stage in the liquid program, when the steam
enters into chamber from the jacket and discharges steam from the exhaust port,
the purpose is to gradually replace the cold air in the inner chamber.
Pulse count: The function of pulsation is to forcibly empty the cold air in the
sterilization room and sterilized articles by vacuum pump before sterilization. The
amount of cold air removed determines the sterilization effect, and the number of
pulsation times and the amplitude of pulsation determine whether the air is
completely removed.
Sterilization Temperature: This temperature should be set according to
different sterilization articles and production processes. Different temperatures
will have different effects on sterilized articles. High temperatures will require
shorter sterilization time, otherwise longer sterilization time will be required.
Sterilization Time: The sterilization time should be set differently according
to different sterilization articles and production processes, with a maximum of
9999 seconds (166.65 minutes). Sterilization time includes heat penetration time,
heat death time and safe death time. Penetration time refers to the time
required after the sterilization chamber reaches the set sterilization temperature
and starts recording, and when the inside of the sterilized article also reaches the
set sterilization temperature. Thermal death time refers to the killing time of
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TD-XT-D004-001 V2.19
microorganisms at the specified sterilization temperature, generally 121 ℃ (12
minutes), 126 ℃ (10 minutes) and 132 ℃ (3 minutes). The safe time is to ensure
the effectiveness of sterilization. Generally, 1/2 ~ 1/3 of the thermal death time
of microorganisms is taken.

Note: Too long sterilization time will affect sterilized articles!

Drying Time-This time should be set according to different sterilized articles


and production processes, with a maximum of 9999 seconds (166.65 minutes).
Drying depends on the high temperature of the jacket to maintain baking and the
vacuum pump to maintain the vacuum degree of the chamber. After a certain
period of time, the moisture in the sterilized articles is gradually volatilized and
kept dry and clean.
Chamber pressure limit: refers to the highest set value of internal chamber
pressure during operation. This pressure will be affected by the jacket pressure. In
the process of heating and sterilization, when the temperature is low or high, this
value can be slightly increased or decreased (generally, the increase or decrease of
10kPa corresponds to the increase or decrease of 1 ℃). This value is set according
to the relationship between the pressure and temperature of saturated water
vapor. When the steam is supersaturated (overheated) or not saturated enough
(the steam contains too much water), the relationship between temperature and
pressure does not correspond, and both overheated and unsaturated steam
cannot achieve effective sterilization effect.
2) System parameter setting:
 Vent limit and exhaust limit: If the local atmospheric pressure of the user is
non-standard atmospheric pressure, the return zero position and exhaust
zero position shall be set accordingly, which requires the service personnel
of our factory to set at the beginning of debugging.
 Upper and lower limits of pulsation: If users need to change, please consult
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TD-XT-D004-001 V2.19
after-sales service personnel.
 Time Setting: Change the time in the system maintenance options, and
click Save to modify the current time of the equipment.
3) Special program description: liquid program
The liquid program sterilization load is non-sealed liquid articles, and the
sealed liquid cannot be sterilized during sterilization. The sterilization time defaults
to 20 minutes.
Replacement time-Before the liquid temperature is programmed, the inner
chamber enters steam from the jacket and discharges steam from the exhaust
port at the same time. Its purpose is to gradually replace the cold air in the inner
chamber.
Sterilization Time: For liquid Bottle Volume Sterilization time
articles, it should be set according to (ml) (minutes)
the amount of liquid contained by
75 20
referring to the table on the right. The
250 25
sterilization time listed in this table is
500 30
the minimum time required at the
1000 35
sterilization temperature of 121 ℃.
1500 45
Appropriate correction should be
made according to the specific 2000 45

situation during use. If a lower sterilization temperature is required, the


sterilization time should be prolonged accordingly.
Discharge Pressure Difference-The liquid program adopts a slow discharge
valve during the exhaust process to prevent the pressure in the sterilization
chamber from dropping too fast and causing the liquid to boil excessively or the
vessel in which the liquid is placed to explode. In order to further reasonably
control the exhaust speed, the parameter exhaust pressure difference is
introduced into the program, i.e. The value of the pressure in the inner chamber
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TD-XT-D004-001 V2.19
when the slow exhaust valve is opened each time. If the set exhaust pressure
difference is 10kPa, the slow exhaust valve will be closed after the inner chamber
pressure drops by 10kPa after opening, and the next opening time will be
determined by the parameter exhaust interval.
Exhaust Interval: The time interval between each slow exhaust valve closing
and the next slow exhaust valve opening during liquid exhaust. Setting this
parameter can control the exhaust speed of the inner chamber by controlling the
opening frequency of the slow exhaust valve.

5.3 Manual Operation

Users can manually operate the equipment after logging in with the rights of
technicians and administrators, as shown in Fig. 13. Clicking the automatic button
will switch to the manual operation state, and clicking on each component can
switch it on and off. Among them, F0 inner chamber exhaust valve, F2 inner
chamber intake valve, F3 vacuum extraction valve, F4 empty return valve, F5 slow
discharge valve, F6 water injection valve (water injection pump), F7 circulating
water valve, F8 evaporator pressure relief valve (manual ball valve), DR1
evaporator heating pipe, DR2 heating membrane (no heating membrane for jacket
equipment). Two small triangles respectively represent the high and low water
levels of the evaporator. Then click the Manual button to exit the manual
operation. In the figure B is a vacuum pump. If XG1. C type equipment has no
vacuum pump, evacuation valve F3, circulating water valve F7 and return valve F4.

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TD-XT-D004-001 V2.19

Fig. 13 Fig. 14
Note: The heating pipe DR1, the heating film DR2 and the vacuum pump B
cannot be manually opened for a long time, and the evaporator water level must
be ensured to be higher than the low water level when opening the heating pipe.
The pump should not work for too long without water.

5.4 Program Operation

After logging in with different permissions, select the startup program, enter
the program selection screen as shown in Fig. 10, and select the corresponding
program. If you need to modify the parameters, click Edit to modify the
parameters. If you do not need to modify, click Start directly, enter the startup
parameter screen as shown in Fig. 11, and click the startup program again to enter
the main process screen as shown in Fig. 15.

Fig. 15
1) First, the meter head is printed, and the preparation stage is carried out
after the meter head is printed. The non-liquid program includes the following
stages, namely, "Preparation", "Pulsation", "Heating", "Sterilization", "Exhaust",
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TD-XT-D004-001 V2.19
"Drying" and "End" stages. Liquid procedures include: "Preparation", "Purge",
"Heating", "Sterilization", "Exhaust" and "End" stages.

2) While the program is running, Click the numerical display button to


monitor the running times and running time of each stage in real time from the
screen, display the pressure and temperature in the sterilization chamber on the
main process screen and display the current stage of the equipment, as shown in
Fig. 15 (when the program is running or has been running, there is a light on the
top of the stage, such as).

5.5 Precautions for Sterilization Operation

 During the operation of the program, the operator should not stay away
from the equipment and pay attention to the operation of the equipment.
 Manual operation procedures can only be performed by operators who are
familiar with the characteristics of sterilization equipment and articles to be
sterilized.
 If the display does not respond, you can choose the mode of power failure
and restart to check whether there is any problem with the control system.

When using the sterilizer to sterilize below 132 ℃, it is


necessary to manually adjust the upper limit of the evaporator pressure
controller to about +40 of the inner chamber pressure limit. For example,
when sterilizing at 121 ℃, it is necessary to manually adjust the
evaporator pressure controller to 130-150kPa, otherwise the inner
chamber temperature in the sterilization stage will exceed the
sterilization temperature by 121 ℃.
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TD-XT-D004-001 V2.19
Precautions for liquid sterilization:
* Please use liquid sterilization carefully to avoid accidents such as explosion
and scalding, and strictly abide by the following operations;
 Liquids can only be non-closed liquids
 Only the liquid can be sterilized by the liquid program. It is strictly
prohibited to start the pump to evacuate after exhaust, otherwise bottle
explosion and liquid boiling will occur.
 After sterilization is completed, when the temperature of the chamber
drops below 80 ℃ (settable), open the cabinet door to a gap of about
10mm and wait for about 10 minutes, then open the large cabinet door and
take out the liquid bottle.
 When loading or taking out the liquid bottle, you should handle it with care
as much as possible to avoid turbulence, vibration and collision.

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TD-XT-D004-001 V2.19
Chapter VI Troubleshooting

In the process of use, we should be alert to every abnormal thing,


such as pipeline leakage, compressed gas leakage, programs different from usual,
etc.

6.1 Analysis and troubleshooting of common faults:

A. Equipment Alarm Information Table:

SN Alarm information Analysis


The chamber temperature
Alarm
detection error, please check the Check wiring, PT100, etc.
Code 1
wiring.
Alarm Record temperature detection
Check wiring, PT100, etc.
Code 3 error, please check wiring.
The boiler wall temperature
Alarm
detection error, please check Check wiring, PT100, etc.
Code 4
wiring.
Alarm The chamber pressure test error, Check wiring, pressure
Code 7 please check wiring. transmitter, etc.
Alarm Evaporator water level detection Check wiring, water level relay,
Code 12 error. water level probe, etc.
Check the water source pressure
Alarm
The evaporator is short of water. to see if the inlet solenoid valve
Code 13
is damaged.
Vacuum pump thermal protector
overload protection, please reset
the thermal relay, and check the
Alarm thermal relay protection current,
Vacuum pump protection.
code 15 water supply, three-phase power
supply, and whether there is
foreign matter blocking the
vacuum pump, etc.
Alarm The door is not closed and the Programs cannot be initiated
Code 17 program cannot be started. until the front (rear) door is
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TD-XT-D004-001 V2.19
closed
Please wait until the pressure in
Alarm There is negative pressure in the
the chamber is higher than the
code 20 chamber and the door cannot open.
limit before opening the door.
Please wait until the pressure in
There is positive pressure in the
Alarm the chamber is lower than the
chamber and the door cannot
code 21 vent limit before opening the
open.
door.
Please ask the customer service
Alarm The program is not configured and personnel to configure the
code 23 cannot be started. program parameters before
starting the program.
Equipment without vacuum
pump cannot run vacuum
Alarm Non-pulse vacuum equipment programs, such as lumen
code 25 cannot run vacuum programs program, BD program, PCD
program, leakage program and
drying program.
The equipment configuration
Please configure the hardware
Alarm code has not been set, so
parameters of the equipment for
code 30 after-sales personnel should be
the factory-level service personnel.
found to configure it.
Sterilization parameters are
Alarm Parameter has been initialized, restored to their default values
code 32 please reset. and need to be set again as
needed.
Check the water source pressure
Alarm
Evaporator water injection timeout. to see if the inlet solenoid valve
code 35
is damaged.
The temperature and pressure of Check whether the steam quality
Alarm
the inner chamber correspond is qualified and calibrate the
code 37
abnormally. temperature and pressure.
Check the steam quality and
Alarm The chamber over-temperature
whether the chamber pressure
code 38 alarm.
limit is too high.
Check the steam quality and
Alarm Chamber over-pressure, please
whether the chamber pressure
Code 44 check.
limit is too high.

B. Analysis and troubleshooting of common faults:

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TD-XT-D004-001 V2.19
Any parts and electrical components have their own inherent service life, and
faults are difficult to avoid. In order to help the operation and maintenance
personnel find out the cause of the failure as soon as possible, the following lists
some possible failures, possible causes of the failure, and treatment and
elimination methods for reference.

Troubleshooting Table of Sterilizer


Failure Possible causes Solutions
1. The power supply of 1. Check the text
1. After turning on the the display screen is not power supply;
power, the display connected; 2. Replace the fuse
screen cannot work. 2. The fuse is blown out; 3. Check the 24V
3. No 24V power supply power supply
1. Please close the
1. The cabinet door is
2. The program does cabinet door
not closed properly.
not start 2. Check and
2. Alarm not eliminated
eliminate alarms
1. Replace the
1. The communication
communication line to
interface is burnt out
3. Display check whether the
due to live plug
Communication Failure interface is burnt out;
unplugging;
2. After shutdown,
2. Poor contact;
reconnect;
1. Check
1. Poor communication communication and
4. No display on the
line contact restart
screen
2. No 24V power supply 2. Check the 24V
power supply

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TD-XT-D004-001 V2.19
1. Check all
connecting parts of
the pipeline and carry
out pressure keeping
test;
2. Adjust that opening
1. There is leakage in of the ball valve;
the evacuation pipeline; 3. Check whether
2. Improper adjustment there is water supply;
of flow ball valve; 4. Check or replace
3. No water or the water the pressure
pressure is low; transmitter;
4. Pressure transmitter 5. Repair or replace
5. The pump evacuates failure; the check valve;
too slowly and the 5. The one-way valve of 6. Check valves and
negative pressure is the chamber drain pipelines and make
not up to the standard. pipeline is damaged; necessary cleaning;
6. Condensate exists in 7. Check the solenoid
the pipeline system; valve or pump;
7. The evacuation valve 8. Carry out chemical
or pump is not opened; descaling on
8. Too much fouling in condenser, pump and
the pipeline other pipeline systems
9. Plateau issues 9. Absolute and
relative pressures at
high altitude are not
consistent. Please
refer to Table 3:
Pressure Calibration
Table
1. The water source is
1. Check the water
not connected;
source;
2. The angle of the
2. Adjust that opening
pump inlet ball valve is
6. The vacuum pump is angle of the ball valve;
too large.
noisy 3. Descaling pump
3. Vacuum pump scaling
and pipeline
is serious
4. Adjust ball valve
4. The circulating water
angle
pressure is too high

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TD-XT-D004-001 V2.19
1. Check the vacuum
1. No power supply;
7. Vacuum pump does pump power supply;
2. The vacuum pump is
not start 2. Replace that
damaged;
vacuum pump;
1. Check the solenoid
10. Solenoid valve does 1. Coil failure; valve coil;
not run 2. Loose wiring; 2. Check the solenoid
valve wiring;
1. The jacket trap is
1. Adjust the trap
opened too large;
2. Check steam
2. There is leakage in
12. The jacket pressure leakage
the pipeline
is high but the inner 3. Set the chamber
3. The pressure limit in
chamber pressure pressure limit
the chamber is set too
cannot be increased or 4. Check the solenoid
low.
F2 cannot be opened. valve
4. Solenoid valve
5. Check solenoid
damaged
valve wiring
5. Loose wiring
1. Check the main
1. Main heating is slow
heating
2. That number of
2. Increase that
13. Heating too slowly pulsation is less or the
number of pulsations
replacement time is
or prolong the purge
short
time
1. Adjust the opening
1. The opening of the frequency of the trap
drain valve is too small, 2. Increase the
resulting in accumulated number of pulsations
14. The pressure is water in the drain (default three)
reached, but the pipeline; 3. Increase that
temperature 2. The number of pressure limit of the
cannot rise. pulsations is too small.
3. The pressure in the chamber according to
chamber is slightly the actual
lower.
temperature

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TD-XT-D004-001 V2.19
1. The platinum thermal 1. Check platinum
15. That temperature is
resistor is not connected thermal resistance
shown to be 0 or 200
properly. and reconnect
1. The pressure
16. Pressure is not
transmitter is not 1. Rewire
shown as-100
connected properly
1. Re-grounding the
1. The ground wire is ground wire;
not connected properly; 2. Check the source of
17. Temperature and
2. There is a strong
pressure jump the surrounding
magnetic field around
the equipment; magnetic field;
18. Temperature does 1. Correct 1. Correct chamber
not match
temperature temperature
pressure
1. Wiring error of water 1. The electrician
19. Evaporator water
level float (probe) rechecks the wiring
level detection
2. Water level float 2. Check and replace
error
(probe) damaged float (probe)
1. Clean and check the
solenoid valve
1. The intake valve is
2. Raise the upper
blocked or the exhaust
20. Low Temperature limit of inner chamber
valve leaks
Alarm pressure
2. The cold air is not
Or increase the
discharged cleanly.
number of pulsations
or replacement time.
1. Fill up the water
1. Insufficient water in storage tank and try
the water storage tank again
2. Blockage of the inlet 2. Please check the
filter filter element of
21. Evaporator water evaporator inlet filter
injection timeout 3. Evaporator Water 3. Replace the water
Level Sensor Failure level sensor
4. Add water diversion
4. Check the water or overhaul and
injection pump (if any) replace the water
injection pump

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TD-XT-D004-001 V2.19
1. Please ask the
1. Intracavity pressure
electrician to check
sensor failure the circuit and replace
2. The temperature of
the pressure sensor.
22.Chamber
PT100 in the cavity is
2. Contact the
over-pressure
low supplier to correct the
3. The solenoid valve
deviation
cannot be sealed
Step 3: Clean filters
and solenoid valves
1. Please check the
circuit by the
1. Intracavity PT100
electrician and
sensor disconnected
23. Chamber sensor re-press the sensor
failure connection in the
2. Intracavity PT100
cavity.
temperature fault
2. Examine that
intracavitary PT100
1. The air intake
1. Clean the solenoid
24. Over-temperature solenoid valve cannot valve
in sterilizer be sealed 2. Examine that
chamber 2. Intracavity PT100
intracavitary PT100
temperature fault
25. The indicator light 1. Loose wiring; 1. Loose wiring;
on the rear door 2. The bulb is burnt out 2. Replace bulbs or
panel is not on. or the fuse is broken; fuses;
The pressure gauge is 1. Check the pressure
26. The front and rear
not displayed correctly. gauge
doors show pressure
2. Pressure gauge Step 2 Replace the
discrepancy.
damaged pressure gauge
27. Possible faults of steam generator: (only applicable when the
equipment has its own evaporator)
1. The power cord is
1. Fix the power
not connected
No electricity cord
properly.
2. Replace control
2. Damaged control
switch
switch

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TD-XT-D004-001 V2.19
1. Water level
electrode fault
2. The inlet solenoid
1. Maintenance
valve does not work
No water inflow 2. Maintenance
when electrified.
3. Replace
3. Damage to water
4. Replace
pump
4. Water level relay is
broken
1. Upper water level
detection fault
2. The inlet solenoid 1. Maintenance
valve is not closed 2. Maintenance
Water inflow does not
tightly. 3. Replace
stop.
3. Water level relay is 4. Turn the manual
broken switch to the
4. Manual opening of automatic state
evaporator water
injection
1. Water level
electrode open
circuit
2. Pressure controller 1. Maintenance
contact damaged 2. Replace
No heating 3. Damage of electric 3. Replace
heating pipe 4. Check control
4. AC contactor coil loop
shall not be 5. Replace
electrified.
5. Water level relay is
broken
1. The pressure
control switch is not
The pressure is out of
adjusted correctly. 1. Readjustment
control and the safety
2. Damaged pressure 2. Replace
valve is open.
control switch 3. Replace
3. Pressure gauge
failure
In a word, faults are often of various kinds, but no matter what kind of faults
occur, the possible causes of the faults and the pipelines and circuits involved

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TD-XT-D004-001 V2.19
should be analyzed first according to the fault phenomena, then eliminated one by
one, and finally the real fault points should be found for maintenance. Of course, if
you don't know the working principle of the equipment and the purpose and
installation location of various parts, you can't start. Maintenance should also
know the structural principle of various parts and electrical components.

6.2 Analysis and Troubleshooting of Wet Package:

The weight of dressing bag after sterilization is 3% higher than that


before sterilization. This phenomenon is called wet package phenomenon.
 Loading problem: Is the loading capacity too large so that some packages
come into contact with the wall of the sterilization chamber and condensed
water seeps into the packages. Check whether there are any accumulated
water vessels in the bag, so that condensed water cannot be drained during
sterilization.
 Poor drainage pipes: Check whether there are too many corners in the
drainage pipes, which are discharged from low to high, and whether there
are impurities blocking the pipes.
 Damage to the one-way valve of the drain pipe in the chamber: This is
manifested as wet outside and dry inside, and the water in the drain pipe
flows back to the chamber during drying.
 The drying time is too short: increase the drying time appropriately to
observe whether the drying effect is improved.
 Negative pressure does not meet the standard: check according to "Sterilizer
Failure and Troubleshooting Table".
 Local wet package should be analyzed according to the specific wet package

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TD-XT-D004-001 V2.19
position and comprehensively investigated.

6.3 Analysis and elimination of unqualified sterilization:

The three major elements of sterilization: saturated steam, sterilization


temperature and time.
 Washing of articles: Check whether each washing process is strictly operated
according to the working flow of the supply room to ensure the cleaning
quality.
 Packaging of articles: whether the packaging is too large and tight, whether
the packaging materials are breathable and other factors will affect the
removal of cold air and the penetration of steam.
 Loading principle: whether the loading is placed according to regulations,
whether the loading is too tight and the quantity is too large to affect the
smooth circulation of steam.
 Residue of cold air: The amount of cold air removed determines the effect of
disinfection and sterilization, so it is important to check whether the
performance of sterilization equipment is normal. First, use B-D test paper
for detection. If there is any problem, carry out pressure maintenance test
or use manual operation to pass the inner chamber into steam to check
whether there is leakage in pipelines and other places.
 Sterilization temperature: check whether the actual temperature in the
package reaches the sterilization temperature and is consistent with the
displayed temperature by using a point thermometer, check whether the
inner chamber pressure and temperature correspond to each other, and
appropriately increase the inner chamber pressure to see if the observation

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TD-XT-D004-001 V2.19
results have improved.
 Sterilization time: whether the setting of sterilization time is reasonable,
whether the steam intake in the inner chamber is too fast, whether the
penetration time is not enough, and whether the observation results are
improved by appropriately prolonging the time.
 Faults of sterilization equipment: refer to the "Sterilizer Faults and
Troubleshooting Table" for systematic investigation of the equipment.
 Improper detection method, repeated detection or other batch number
reagents.

6.4 Problems that cannot be resolved:

After careful analysis and investigation, you may encounter some problems that
cannot be solved through analysis. At this time, you need to make preparations in
the following order:
 Record the model of the defective equipment and the cabinet number
below the front end of the chamber.
For example: XG1.UCD-135M 20106447
 Recall any abnormalities in the operation of the equipment before the
failure, the specific performance after the failure, and what inspections and
adjustments you have made. Try to analyze the possible causes and parts
that may be damaged, and record them.
 Contact the regional office or the company's after-sales service department
to tell us what you know. We will give you technical guidance or arrange
personnel to repair according to the situation you reflect.

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TD-XT-D004-001 V2.19
Chapter VII Troubleshooting

7.1 How to check and replace the safety valve

In order to prevent the safety valve from being blocked, the steam pressure
is released through it once a month during normal use.
1. According to the manual, carry out sterilization operation.
2. A pressure of 0.21 MPa was generated in the sterilization container.
3. Push the safety valve pull ring with a screwdriver so that it is open for
approx. 2 seconds.
4. Turn off the main switch and terminate the operation. At that same time,
the water vapor in the sterilization contain is discharged.
5. Wait until the pressure drops to 0MPa before opening the door.

Replace safety valve:


This operation is limited to professionals only.
1. Remove safety valve.
2. Replace it with a qualified safety valve. (Qualification criteria: ensure that
the safety valve is opened when the pressure is between 0.24 MPa and 0.25 MPa).
3. Test a sterilization process.
4. Check the opening pressure and closing pressure of the safety valve once
a year.
7.2 Procedures for Replacing Electric Heating Pipe

This operation is limited to professionals only.


1. Remove the rear cover of the sterilizer.
2. Remove the wiring on the steam generator heating pipe.
3. Remove the heating pipe.
4. Replace the damaged electric heating pipe with a new one.
5. Rewire.
6. Install sterilizer rear cover.
7. Test a sterilization process.
7.3 Cleaning of solenoid valve

1. Remove the sterilizer housing.


2. Use a screwdriver to remove the stainless steel tablettes on the top of the
solenoid valve to be cleaned or use a wrench to remove the nuts on the coil.
3. Lift solenoid coil.

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TD-XT-D004-001 V2.19
4. Open the valve body with a wrench.
5. Rinse the solenoid spool with clean water.
6. Re-install the solenoid valve.

Remove:
According to the left
steps, then use a
wrench to twist the
large hexagon copper
cap above the valve
body to open the
spool.

Hexagonal
brass nut

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TD-XT-D004-001 V2.19
7.4 Cleaning of water inlet filter and drainage filter

1. The inlet filter is used to prevent foreign matters from entering the
evaporator.
2. Drainage filters are used to prevent foreign matters from entering internal
pipelines and solenoid valves.
3. Remove the filter gland with a wrench and take out the filter screen.
4. Clean up the sundries on the filter net with clean water.
5. Re-install the filter.

7.5 Replace the water level detection device

Warning: Make sure the machine is powered off.


1. Remove the rear cover of the sterilizer.
2. Remove the wiring of high, medium and low water level probes.
3. Remove the high, medium and low water level probe.
4. Replace the damaged water level probe with a new one.
5. Re-install the water level detection device and connect it.
6. Install the sterilizer rear cover.
7. Re-test all working processes to prevent water leakage, wiring errors,
installation jamming and other problems

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TD-XT-D004-001 V2.19
7.6 Use and Maintenance of Origami Printer

Printer
window Baffle

Two fixed points


suspended from a
paper groove for
securing the paper
groove

Press the lower right corner of the window door lightly, and the window door

pops open. If you want to take out the origami hanging slot, you need to first press

and hold the origami baffle with your hand, then lift the hanging slot upward and

take it out.

The appearance of the printer is stored and printed. After holding down the

baffle, the origami paper slot is shown in the following figure.

This is where
Baffle the paper goes
into the slot

Fixed plate

Note: Paper should enter the slot between the baffle plate and the fixed plate.

Press the lower right corner or upper right corner of the printer window door,

and when you hear the faint closing sound of the switch, the window door can

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TD-XT-D004-001 V2.19
pop open. The printer uses origami to print, and the printed paper is automatically

folded and stored in the paper slot.

Power Paper feeding


button

Printing
Paper slot
hanging hole
Paper
feeding
slot
Spare paper

Open the printer window and the appearance of the paper slot.

After opening the printer window door, as shown in the figure, the green light

in the upper left corner is the power indicator light, the red print indicator light in

the lower corner, and a paper feeding button in the upper right corner (when

pressed, the printing paper will quickly feed); When the printer is working, the red

indicator light is on. When replacing the printing paper, first remove the hanging

paper slot, then insert the printing paper horizontally into the paper feed slot,

press and hold the paper feed button in the upper right corner (power on), paper

will automatically enter, and hang the paper slot for storing the recording paper.

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TD-XT-D004-001 V2.19
7.7 Components that are only allowed to be maintained and replaced by

professionals

When replacing and maintaining the following accessories, please


contact professional personnel for operation. Users are not allowed to replace and
maintain them without permission.
The following is a list of spare parts that are only allowed to be maintained and
replaced by professionals:

Order No.: XG1.UCD-100M

SN P&ID Name Origin Size/Range Qty

Solenoid
1 F2 Japan Rc3/8 1
valve
F4, F5, Solenoid
2 Japan Rc1/4 4
F6, F7 valve
Solenoid
3 F0, F3 Japan Rc1/2 2
valve
Vacuum
4 B Germany Rc1 1
pump
5 GB Add pump Italy Rc 1/4 1
Temperature
6 T1 China 0 ~ 180 ℃ 1
probe
7 NA Air filter China R1/4 1
8 NA Sealant strip China NA 2
9 NA Travel switch Japan NA 2
Pressure
10 NA Japan NA 4
switch
Pressure
11 NA Switzerland NA 2
transmitter
Control
12 NA China NA 1
system

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TD-XT-D004-001 V2.19
Order No.: XG1.UCD-135M, XG1.UCD-185L

SN P&ID Name Origin Size/Range Qty

Solenoid
1 F2 Japan Rc3/8 1
valve
F4, F5, F6, Solenoid
2 Japan Rc1/4 4
F7 valve
Solenoid
3 F0, F3 Japan Rc1/2 2
valve
Vacuum
4 B Germany Rc1 1
pump
5 GB Add pump Italy Rc 1/4 1
Temperature
6 T1 China 0 ~ 180 ℃ 1
probe
7 NA Air filter China R1/4 1
8 NA Sealant strip China NA 2
9 NA Travel switch Japan NA 2
Pressure
10 NA Japan NA 4
switch
Pressure
11 NA Switzerland NA 2
transmitter
Control
12 NA China NA 1
system

Order No.: XG1.UCD-300M

Origin Size/Range Qty


SN P&ID Name

1 F2 Solenoid valve Japan Rc3/8 1


F5, F6, Japan Rc1/4 3
2 Solenoid valve
F7
F0, F4, Japan Rc1/2 3
3 Solenoid valve
F3
4 B Vacuum pump Germany Rc 1 1
5 GB Add pump Italy Rc 1/4 1
6 T1 Temperature China 0 ~ 180 ℃ 1
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TD-XT-D004-001 V2.19
probe

7 NA Air filter China R1/2 1


8 NA Sealant strip China NA 2

9 NA Travel switch Japan NA 2

Pressure
10 NA Japan NA 4
switch
Pressure
11 NA Switzerland NA 2
transmitter

12 NA Control system China NA 1

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TD-XT-D004-001 V2.19

Chapter VIII Maintenance

8.1 Safety Instructions

When running and maintaining this equipment, the following safety


precautions must be read carefully.

 Burn hazard: If the ambient temperature is higher than 30°C, the surface
temperature of the sterilization chamber door may be very high (>70°C).
 Burns and electric shock: Repairs or adjustments must be performed by
trained professionals. Running this equipment by untrained or authorized
personnel or installation of unauthorized parts will result in damage to
personnel and equipment.

 When label (high voltage danger) is observed, the main switch


must be turned off before turning on.
 Burn hazard: Make the sterilizer, evaporator (if any) and other
accessories to cool to room temperature before cleaning or maintaining.
 Do not use a sterilizer to handle flammable liquids, nor use glass bottles
or glass utensils for sterilization of sealed liquids.
 Burn hazard: After the cycle finished, the sterilizer and sterilization
cart/joists will be hot. Wear protective gloves and coveralls (face
coverings when handling liquids) when removing loads.
 Fall hazard: In the unloading area of the sterilizer, items should be

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TD-XT-D004-001 V2.19
prevented from falling. Sterile bags dropped on the ground or misplaced
in an unclean place should be considered contaminated.
 Explosion hazard: This sterilizer is not used for any flammable liquid.
 Danger of burns: When sterilizing liquid, in order to avoid personal injury
or property damage caused by bottle explosion and hot liquid, the
following regulations must be observed:
1) Only use the liquid cycle to handle liquids, and prohibit the use of
other cycles to handle liquids;
2) Only use ventilated cover, do not use closed screw caps or rubber
plugs;
3) Only use borosilicate glass bottles - do not use ordinary bottles or
bottles that cannot be used for sterilization;
4) Do not open the door immediately when cycle ended. After the
liquid cycle finished, wait for more than 10 minutes before opening the
door and unloading the sterilized items;
5) Be slowly when pulling the trolley out , do not bump the hot
bottle, otherwise it may cause the explosion! If there is boiling or
bubbling in the bottle, do not move the bottle;
6) After the bottle is cool enough to touch, move it from the sterilizer
rack to the storage area.
 Risk of burns: failure of the steam supply can cause the sterilization
chamber to fill with very hot water. If the auto-complete cycle fails, wait
for the program auto-processing to end before opening the door. Do not
open the chamber door if water leaks from the door gasket.
 Sterility Assurance Hazard: If chemical monitoring, biological monitoring,
B&D testing, etc. fail, the sterility of the load will not be guaranteed. If
these problems occur, please contact professional maintenance
personnel.
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TD-XT-D004-001 V2.19
 Risk of sterility assurance: The quick sterilization cycle should not be used
as a routine sterilization cycle for items. It should be used in emergencies
and is only applicable to the sterilization of bare instruments. The
procedure may not include the drying stage. Avoid contamination during
transportation. Use within 4 hours. No storage.

Before entering the sterilization room, the operator or


maintenance personnel should turn off the sterilizer and keep the key of the
sterilization room to prevent the chamber door from being closed and
endangering human life!

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TD-XT-D004-001 V2.19
8.2 Maintenance plan

Even if the equipment is running normally without any faults, it should be


overhauled after the equipment has been running for a certain period of time.
Failure is not only related to the service life and intrinsic quality of components,
but also has a great relationship with the correct use method and daily
maintenance. Many failures are caused by improper use, incorrect operation, and
lack of attention to routine maintenance and regular inspections
The correct use and routine maintenance of sterilization equipment are
necessary conditions to prolong the service life of equipment and reduce failures.
Improper equipment maintenance will shorten equipment service life.
The maintenance frequency in the following table is the minimum
requirement, and the maintenance frequency should be appropriately increased
according to the usage frequency and usage environment.

Table 8-1 List of common maintenance items 1 (according to importance)


Min
SN Importance Type Item Staff
frequency
Comply with
1. very important Safety Inspection of pressure vessels Technician relevant
regulations
Comply with
2. very important Safety Calibrate safety valves and pressure gauges Technician relevant
regulations
Check whether the live wire, ground wire and
3. very important Safety neutral wire at the main power supply of the Technician Each quarter
equipment are fastened
Check the wiring and terminal protective cover of
4. very important Safety Technician Each quarter
the strong electric parts such as the heating tube
Generator water level probe (or float) and level
5. very important Safety gauge cylinder cleaning and descaling (built-in Technician Each quarter
generator)
Check dry-burn protection (built-in generator, if
6. very important Safety Technician Half year
present)
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TD-XT-D004-001 V2.19
7. very important Safety Check the safety valve for water or steam leaks Technician Half year
Check the heating pipe for water leakage (built-in
8. very important Safety Technician Half year
generator)
9. very important Safety Check all wires of for damage Technician Half year
Check door safety, including all door position
10. very important Safety Technician Half year
switches, barrier guards and moving parts
Check whether the upper and lower limits of the
11. very important Safety generator pressure are within the specified range Technician Half year
(built-in generator equipment)
Check that the warning signs of the equipment are
12. very important Safety Technician Each year
complete and the icons are clear and easy to see
Check that the operating procedures of the
13. very important Safety Technician Each year
equipment are complete
14. very important Safety Check the pressure safety interlock Technician Each year
Check the front and rear door emergency stop
15. very important Safety Technician Each year
switches (if any)
Make sure all signal wires are not pinched when
16. very important Safety Technician Each year
opening and closing the door
Confirm that all spare parts in the maintenance
17. very important Safety Technician Each year
room are not affected by water vapor
Make sure the wiring ducts and terminal shields are
18. very important Safety Technician Each year
complete and there is no potential for electric shock
19. very important Safety Check Ground Impedance Technician Each year
20. very important Safety Check if the low level switch is valid Technician Each year
Replace the heating tube contactor of the generator
21. very important Safety Technician Four years
(built-in generator device)
Check the corresponding relationship between the
22. Important Performance Technician Each day
chamber temperature and the chamber pressure
23. Important Performance Check all pipes for leaks Operator Each day
24. Important Performance Leak test Operator Each week
Check whether the energy supply meets the
25. Important Performance Technician Each week
requirements of the Manual
26. Important Performance Clean all filters on pipes Technician Each month
Cleaning of generator steam drum and heating
27. Important Performance Technician Each quarter
tube(built-in generator)
Check whether the liquid level display glass tube of
the generator is displayed correctly, and check
28. Important Performance Technician Each quarter
whether the sealing gasket of the liquid level gauge
is leaking (built-in generator equipment)
Dust removal of electrical components and
29. Important Performance Technician Each quarter
equipment valve sensors inside the electrical box
Clean all traps on equipment and steam lines (if
30. Important Performance Technician Half year
any)
31. Important Performance Check and tighten check valve Technician Half year
32. Important Performance Door moving parts’ lubrication and inspection Technician Half year
Inspection and descaling of pressure transmitter
33. Important Performance Technician Half year
connections
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TD-XT-D004-001 V2.19
Check and clean the working fluid inlet and
cavitation protection port of vacuum pump, check
34. Important Performance Technician Half year
the suction of the pump, no leakage during
operation
Check the recent alarm log to find the cause and
35. Important Performance assess whether it is caused by one component Technician Half year
failure
Check the PT100 for water leakage, damage, bumps
36. Important Performance Technician Half year
and wiring
Check the pressure transmitter for leaks, damage,
37. Important Performance Technician Half year
bumps and wiring
Check the chamber temperature and record the
38. Important Performance Technician Half year
temperature difference value
Periodically clean all water tanks of the equipment
39. Important Performance Technician Half year
(if any)
Check whether the equipment drainage pipe is
40. Important Performance Technician Half year
smooth
41. Important Performance Vacuum pump cleaning and descaling (if any) Technician Half year
Check the integrity of equipment and external
42. Important Performance Technician Each year
piping insulation
Check that the front and rear door rails are level and
43. Important Performance Technician Each year
tightened, and clean the rails (if any)
44. Important Performance Inspect and clean the steam baffle Technician Each year
45. Important Performance Check and clean all flow-limiting fittings (if any) Technician Each year
Check the integrity and stability of the vacuum
46. Important Performance Technician Each year
pump vibration damping pad
47. Important Performance Check all valves for leaks Technician Each year
48. Important Performance Check if the key switch is in good contact Technician Each year
49. Important Performance Calibrate date and time Technician Each year
50. Important Performance Replace door gasket Technician Each year
Detect parameters such as temperature, pressure
51. Important Performance Technician Each year
and time with a temperature and pressure detector
Replace the generator water level gauge gasket
52. Important Performance Technician Each year
(Built-in generator equipment)
53. Important Performance Replace all clamp pads on pipes Technician Each year
54. Important Performance Replace air filter element Technician Each year
55. Important Performance Remove and cleaning bolt Technician Each year
56. Important Performance Replace PLC battery Technician Two years
57. Important Performance Maintain vacuum pump Technician Two years
General
58. Common Clean sterilizer chamber, rails and filters Operator Each day
Requirement
General
59. Common Clean the grill Operator Each day
Requirement
General
60. Common Clean equipment surfaces Operator Each day
Requirement
61. General Common Check device print records or monitor data Operator Each day
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TD-XT-D004-001 V2.19
Requirement
General
62. Common Evaporator drain (built-in generator equipment) Operator Each day
Requirement
General Check and clean door gasket and door sealing
63. Common Operator Each week
Requirement groove
General Check whether the grille is running normally, the
64. Common Operator Each month
Requirement docking is smooth, and the bolts are loose (if any)
General
65. Common Check printer Operator Each month
Requirement
General Check and clean equipment panels and service
66. Common Operator Each month
Requirement spaces
General
67. Common Clean the printer thermal head Operator Each year
Requirement
General
68. Common Check equipment nameplate integrity Operator Each year
Requirement
General
69. Common Calibrate the touchscreen Operator Each year
Requirement

Table 8-2 List of common maintenance items2(According to maintenance


cycle, the same as 8-1)
Min
SN Importance Type Item Staff
frequency
Comply
very with
70. Safety Inspection of pressure vessels Technician
important relevant
regulations
Comply
very with
71. Safety Calibrate safety valves and pressure gauges Technician
important relevant
regulations
Check the corresponding relationship between the
72. Important Performance Technician Each day
chamber temperature and the chamber pressure
73. Important Performance Check all pipes for leaks Operator Each day
General
74. Common Clean sterilizer chamber, rails and filters Operator Each day
Requirement
General
75. Common Clean the grill Operator Each day
Requirement
General
76. Common Clean equipment surfaces Operator Each day
Requirement
General
77. Common Check device print records or monitor data Operator Each day
Requirement
General
78. Common Evaporator drain (built-in generator equipment) Operator Each day
Requirement
79. Important Performance Leak test Operator Each week
Check whether the energy supply meets the
80. Important Performance Technician Each week
requirements of the Manual
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TD-XT-D004-001 V2.19
General Check and clean door gasket and door sealing
81. Common Operator Each week
Requirement groove
82. Important Performance Clean all filters on pipes Technician Each month
General Check whether the grille is running normally, the
83. Common Operator Each month
Requirement docking is smooth, and the bolts are loose (if any)
General
84. Common Check printer Operator Each month
Requirement
General Check and clean equipment panels and service
85. Common Operator Each month
Requirement spaces
Check whether the live wire, ground wire and
very
86. Safety neutral wire at the main power supply of the Technician Each quarter
important
equipment are fastened
very Check the wiring and terminal protective cover of
87. Safety Technician Each quarter
important the strong electric parts such as the heating tube
Generator water level probe (or float) and level
very
88. Safety gauge cylinder cleaning and descaling (built-in Technician Each quarter
important
generator)
Cleaning of generator steam drum and heating
89. Important Performance Technician Each quarter
tube(built-in generator)
Check whether the liquid level display glass tube
(or magnetic flap) of the generator is displayed
90. Important Performance correctly, and check whether the sealing gasket of Technician Each quarter
the liquid level gauge is leaking (built-in generator
equipment)
Dust removal of electrical components and
91. Important Performance Technician Each quarter
equipment valve sensors inside the electrical box
very Check dry-burn protection (built-in generator, if
92. Safety Technician Half year
important present)
very
93. Safety Check the safety valve for water or steam leaks Technician Half year
important
very Check the heating pipe for water leakage (built-in
94. Safety Technician Half year
important generator)
very
95. Safety Check all wires of for damage Technician Half year
important
very Check door safety, including all door position
96. Safety Technician Half year
important switches, barrier guards and moving parts
Check whether the upper and lower limits of the
very
97. Safety generator pressure are within the specified range Technician Half year
important
(built-in generator equipment)
Clean all traps on equipment and steam lines (if
98. Important Performance Technician Half year
any)
99. Important Performance Check and tighten check valve Technician Half year
100. Important Performance Door moving parts’ lubrication and inspection Technician Half year
Inspection and descaling of pressure transmitter
101. Important Performance Technician Half year
connections
Check the recent alarm log to find the cause and
102. Important Performance assess whether it is caused by one component Technician Half year
failure
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TD-XT-D004-001 V2.19
Check and clean the working fluid inlet and
cavitation protection port of vacuum pump, check
103. Important Performance Technician Half year
the suction of the pump, no leakage during
operation
Check the PT100 for water leakage, damage,
104. Important Performance Technician Half year
bumps and wiring
Check the pressure transmitter for leaks, damage,
105. Important Performance Technician Half year
bumps and wiring
Check the chamber temperature and record the
106. Important Performance Technician Half year
temperature difference value
Periodically clean all water tanks of the equipment
107. Important Performance Technician Half year
(if any)
Check whether the equipment drainage pipe is
108. Important Performance Technician Half year
smooth
109. Important Performance Vacuum pump cleaning and descaling (if any) Technician Half year
very Check that the warning signs of the equipment are
110. Safety Technician Each year
important complete and the icons are clear and easy to see
very Check that the operating procedures of the
111. Safety Technician Each year
important equipment are complete
very
112. Safety Check the pressure safety interlock Technician Each year
important
very Check the front and rear door emergency stop
113. Safety Technician Each year
important switches (if any)
very Make sure all signal wires are not pinched when
114. Safety Technician Each year
important opening and closing the door
very Confirm that all spare parts in the maintenance
115. Safety Technician Each year
important room are not affected by water vapor
Make sure the wiring ducts and terminal shields
very
116. Safety are complete and there is no potential for electric Technician Each year
important
shock
very
117. Safety Check Ground Impedance Technician Each year
important
very
118. Safety Check if the low level switch is valid Technician Each year
important
Check the integrity of equipment and external
119. Important Performance Technician Each year
piping insulation
Check that the front and rear door rails are level
120. Important Performance Technician Each year
and tightened, and clean the rails (if any)
121. Important Performance Inspect and clean the steam baffle Technician Each year
122. Important Performance Check and clean all flow-limiting fittings (if any) Technician Each year
123. Important Performance Check all valves for leaks Technician Each year
124. Important Performance Check if the key switch is in good contact Technician Each year
125. Important Performance Calibrate date and time Technician Each year
126. Important Performance Replace door gasket Technician Each year
Detect parameters such as temperature, pressure
127. Important Performance Technician Each year
and time with a temperature and pressure detector
128. Important Performance Replace the generator water level gauge gasket Technician Each year
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(Built-in generator equipment)
129. Important Performance Replace all clamp pads on pipes Technician Each year
130. Important Performance Replace air filter element Technician Each year
131. Important Performance Remove and cleaning bolt Technician Each year
General
132. Common Clean the printer thermal head Operator Each year
Requirement
General
133. Common Check equipment nameplate integrity Operator Each year
Requirement
General
134. Common Calibrate the touchscreen Operator Each year
Requirement
Check the integrity and stability of the vacuum
135. Important Performance Technician Each year
pump vibration damping pad
136. Important Performance Replace PLC battery Technician Two years
137. Important Performance Maintain vacuum pump Technician Two years
very Replace the heating tube contactor of the
138. Safety Technician Four years
important generator (built-in generator device)
Note 1: Operator refers to hospital sterilizing staff, Technician refers to hospital equipment section maintenance
personnel or manufacturer after-sales service personnel.
Note 2: The operation methods corresponding to the above maintenance items are detailed in the Manual section
8.3.1-8.3.69.

8.3 Maintenance Guide

8.3.1Inspection of pressure vessels

The product belongs to the special equipment, should be used in accordance


with special equipment regulations require registration, maintenance and periodic
inspection.

8.3.2 Calibrate safety valve and pressure gauge

This product belongs to special equipment, and safety accessories such as


safety valves and pressure gauges should be regularly calibrated in accordance
with the requirements of special equipment regulations.

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8.3.3 Check the corresponding relationship between the chamber temperature

and chamber pressure

Check the printed record (or monitoring data) of the sterilization process, and
its physical parameters should meet the following requirements:
(1) The lower limit of the sterilization temperature range is the sterilization
temperature, and the upper limit should not exceed the sterilization
temperature +3°C.
(2) The sterilization physical parameters of the pressure steam sterilizer
should meet the requirements of the following table:
Cycle Items Temperature Minn time Pressure range

Liquid open liquid 30min


Dressings 121℃ 30min 102.8-122.9kPa
Gravity
Instrument 20min
121℃ 20min 102.8-122.9kPa
Instrument,
Pre-vacuum 132℃ 184.4-210.7kPa
dressings 4min
134℃ 201.7-229.3kPa

8.3.4 Check all pipes for leaks

Observe all pipe connections with a flashlight, tighten all leak points, and
replace gaskets if still leaks.

8.3.5 Clean the chamber, guide rails and filters

(1) Please disconnect the power supply of the sterilizer before cleaning.
(2) After the chamber temperature drops to room temperature, wet the
clean cotton cloth with pure water, wipe the chamber and guide rails,
and use copper water to enhance the decontamination effect if
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necessary. It is strictly forbidden to use acid cleaners such as rust
removers.
(3) Clean the bottom filter.

8.3.6 Clean the grill

Wet the clean cotton cloth with pure water, wipe the grille, and use copper
water to enhance the decontamination effect if necessary. It is strictly forbidden to
use acid cleaners such as rust remover.

8.3.7 Clean equipment surface

Use a clean cotton cloth to wipe the surface and the display screen. The
stainless steel decorative cover can be scrubbed with stainless steel brightener. Do
not use acid cleaners such as rust remover.

8.3.8 Check equipment printing records or monitoring data

Check all cycle phases and data integrity. (Only for devices with monitoring
computer)

8.3.9 Generator drain (built-in generator unit)

1) Turn off the power;


2) Wait for the pressure gauge to drop to about 0.1MPa;
3) Slowly open the drain valve to drain the water in the steam generator;

The vapour release is dangerous and can cause burns; the


noise can also cause hearing damage.
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1) After draining, close the valve;
2) If necessary, repeat the drainage operation to completely remove the
dirt.
Note: The draining frequency can be adjusted appropriately according to the water
quality.

8.3.10 Check whether the energy supply meets the Manual requirements

1) Water supply requirements


Pressure: 0.15 ~ 0.3MPa, the fluctuation does not exceed 10%.
Temperature: 5 ~ 20℃, high water temperature will affect the vacuum
performance of the equipment.
Water quality: cooling water: tap water or softened water, hardness less than
2mmol/L.
Evaporator water (applicable to electric heating equipment): pure water,
conductivity ≤5 μS/cm.
2) Steam supply requirements(For external steam equipment only)
Pressure: 0.3 ~ 0.5MPa, the fluctuation does not exceed 10%.
3) Power supply requirements
Power supply:AC 380V±38V,50Hz±1Hz;

8.3.11 Check and clean door gasket and door sealing groove

Remove the gasket, carefully clean the sealing groove with clean water, and
then dry it with a clean cotton cloth or gauze; gently scrub the gasket with water,
and put it back into the sealing groove after drying.

8.3.12 Clean all filters on pipelines

The equipment needs to consume a lot of water and steam during the
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long-term operation, and there are more or less impurities in the pipeline, water
source and steam source. The function of the filter is to filter these impurities and
ensure the normal use of the equipment. Therefore, the filter needs to be cleaned
regularly to ensure the normal operation of the equipment. The cleaning method
is as follows:
1) As shown in the figure below, after disassembling the filter, take out the
filter screen.

2) As shown in the figure below, rinse the filter with clean water, and visually
check that there is no particle dirt on the surface. After cleaning, putit back,
reinstall it, and check whether the filter is in good condition.

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The disassembly and cleaning of the filter should be carried


out when the equipment program stops running, and the steam in the chamber
and the interlayer should be completely discharged and cooled to room
temperature, otherwise it will cause burns to the operator!

8.3.13 Check the grille running conditions, whether the docking is smooth, and the

bolts are loose (if any)

Check whether the manual push-pull grille is stuck, and whether the bolts are
loose, adjust and tighten if necessary.

8.3.14 Check and clean maintenance space

Clean up the sewage and debris in the equipment maintenance space and
keep it clean.

8.3.15 Check printer

When press and hold the print test button for more than 3S, the printer can
print data, and then, check whether the print data is clear and complete.

8.3.16 Check whether the live wire, ground wire and neutral wire at the main

power supply of the equipment are fastened

After the equipment is powered off, check whether the connection at the
main power supply of the equipment is loose, and confirm whether it is tightened.

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8.3.17 Check the wiring and terminal protection of the strong electric parts such

as the heating tube

Check whether the wiring is disconnected or touching the high temperature


pipeline, and check whether the terminal protection is softened, carbonized,
coked and yellowed.
Tighten the wiring of the high-current parts such as the heating tube. Use the
PZ2 screwdriver to fasten the motor protector and contactor, and the tightening
torque is 1Nm; 5SY and 5SL series circuit breakers are tightened with the PZ2
screwdriver, and the tightening torque is 2.5 Nm; 3VT8 series circuit breakers are
tightened with a suitable Allen wrench, and the tightening torque is 10Nm.

The equipment must regularly tighten the wiring of the


contactor and circuit breaker. If the wiring screws are loose, the wires will be burnt
at the joints, which may cause a fire in severe cases.

8.3.18 Cleaning and descaling of generator water level probe (or float) and level

gauge cylinder (for built-in generator equipment)

After disassembly, wipe the probe and the cylinder with a rag to remove the
scale on the surface, and test the correctness of the water level after
re-installation.

The presence of sediment or scale on the water level probe


and buoy can cause the water level monitoring failure, which may cause the
equipment to alarm or the heating pipe to dry out!

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8.3.19 Clean generator drum and heating pipe (For built-in generator equipment)

The equipment with its own steam generator will produce scale during the
heating process of the heating pipe. When used for a long time, the accumulation
of scale will affect the overall performance of the equipment and the service life of
the heating pipe. Therefore, clean the generator drum and the heating pipe
regularly to prolong the service life.
When the equipment is powered off, and chamber pressure drops below
0.1MPa, open the drain valve, drain the water in the steam drum, and wait for the
body of the steam drum to cool to room temperature.
1) Remove the protection of the heating tube.
2) Remove the cable and take out the whole electric heating tube group.
3) Soak the electric heating tube group in oxalic acid solution first, then rinse
with clean water and wipe with a rag.
4) After cleaning and wiping, connect the cable, install the protection, and return
to normal use.

When dismantling the heating tube, be sure to turn off the


power of the equipment, drain the water in the steam drum, and wait for the body
of the steam drum to cool down to room temperature, otherwise it may cause
serious personal and equipment damage.

8.3.20 Check whether the liquid level display glass tube of the generator is

displayed correctly, and check whether the sealing gasket of the liquid level gauge

is leaking (For built-in generator equipment)

Check whether the water level display of the liquid level gauge is correct and
whether there is leakage. If so, tighten or replace the gasket.
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8.3.21 Dust removal of electrical components and equipment valve sensors inside

the electrical box

Wipe the surface of electrical components with a dry cloth to remove surface
dust.

8.3.22 Check the anti-dry protection device (For built-in generator equipment, if

any)

Button to increase
the temperature

Button to decrease
the temperature

Fig. 8-6 Anti-dry protection temperature controller

Steps:
1) Turn the key switch to OFF, click the temperature Up button to set the
temperature controller alarm temperature to 130℃.

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2) Turn the key switch to ON, the equipment is in normal standby, waiting for the
temperature of the heating tube to rise.

3) Observe the equipment to see if the equipment alarms "[140] Generator


over-temperature" when the temperature exceeds 130°C. If it alarms, the
anti-dry protection device works normally; if it does not alarm, the anti-dry
protection device is faulty.

4) Turn the key switch to OFF, click the temperature plus button to set the
temperature controller alarm temperature to 150℃.

The equipment must regularly check the anti-dry protection


device. The failure of anti-dry protection devices may cause the heating pipe to
dry-burn, which may cause a fire in severe cases.

8.3.23 Check the safety valve for water leakage or steam leakage

Observe whether there is any leakage of water or steam at the installation


port and discharge port of the safety valve.

8.3.24 Check the heating pipe for water leakage (For built-in generator equipment)

Check whether there are water droplets or rust near the heating tube
terminal. If so, the heating tube needs to be replaced.

8.3.25 Check whether all the wires of the equipment are damaged

Visual inspection, if damaged, replace it.

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8.3.26 Check door safety, including all door position switches, barrier protection,

and moving parts

Check whether the door position switch and barrier switch running normally
and whether the switch position is appropriate. Check whether the moving parts
running normally,whether no abnormal noise during operation, and whether the
fixing bolts are loose.

8.3.27 Check whether the generator upper pressure limit is within the specified

range (For built-in generator equipment)

When running the sterilization program, observe and record the pressure
when the heating tube stops heating during the drying phase, and the pressure
should not be greater than the opening pressure of the safety valve.

8.3.28 Clean all traps (if any) on equipment and steam lines

Remove the fixing bolt on the top of the trap, remove the temperature
sensing element, remove the fixing nut on the filter, and clean the impurities or
foreign matter on the filter.

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The dismantling and cleaning of the trap should be carried out


when the equipment program stops running, after the steam in the chamber and
the interlayer is completely discharged and cooled to room temperature,
otherwise it will cause burns to the operator!

8.3.29 Check and tighten the check valve

After disassembling the inlet end of the check valve, check whether there is
foreign matter or whether the valve clack is working properly.

8.3.30 Lubricate and check door moving parts

The transmission part of the door motor needs to be lubricated regularly to


ensure that the door motor operates smoothly, and the door transmission parts
are regularly filled with lubricating oil.

8.3.31 Check and descale pressure transmitter connections

After removing the pressure transmitter, check and clean the connections for
dirt.

8.3.32 Check recent alarm records to find the cause and assess whether it is

caused by component failure

Open the alarm record on the main menu interface to check and evaluate the
cause of the alarm and whether it is caused by a component failure.

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8.3.33 Check the PT100 for water leakage, damage, bumps and wiring problems

When running, check whether the PT100 connection is leaking, whether it is


bumped, and whether the connection is damaged.

8.3.34 Check the pressure transmitter for water leakage, damage, bumps and

wiring problems

When running, check whether the pressure transmitter is leaking, whether it


is bumped, and whether the connection is damaged.

8.3.35 Check the chamber temperature and record the temperature difference

value

Check the chamber temperature and the record the temperature difference
value during the sterilization stage, and should not exceed 1°C.

8.3.36 Regularly clean all water tanks

Wipe all water tanks of the equipment with a clean rag to remove scale, rust
and other dirt.

8.3.37 Check whether the equipment drainage pipeline is smooth

Disassemble the drain outlet of the equipment, pour water into the drain
pipe, and check whether the drainage is smooth and whether the drain outlet
overflows.

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8.3.38 Check whether the warning signs of the equipment are complete and the

diagrams are clear and easy to see

Check whether the safety warning signs such as anti-scalding equipment are
damaged or missing, whether the icons are contaminated, and whether they are
clearly visible.

8.3.39 Check the Operating Procedures

Check the equipment Operating Procedures for completeness and


contamination.

8.3.40 Check the pressure safety interlock device

1) Do not open the door and alarm when there is pressure in the chamber;
When the chamber pressure is less than -10KPa or more than 10KPa, the
equipment cannot open the door by clicking the OPEN button and has the alarm
function synchronized with the above actions.
2) Can not start the program and alarm if the door is not closed.
When the door is not locked, the program cannot be started by clicking the
RUN button and has the alarm function synchronized with the above action.

8.3.41 Check the front and rear door emergency stop switches (if any)

Run the equipment program with no load, and press the emergency stop
button during operation, all outputs of the equipment should stop until the
emergency stop button is reset and the alarm is confirmed.

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8.3.42 Confirm that all signal lines are not crushed when opening and closing the

door

Operation confirms that all door switch signal lines are not touched or
squeezed by door moving parts.

8.3.43 Confirm that all spare parts in the maintenance room are not affected by

water vapor

Maintenance room inlet and exhaust air is normal, no water or vapor leaks
from equipment, and no water condensation on the ceiling or the surface of each
component.

8.3.44 Confirm that the wire slots and terminal guards are intact and there is no

potential risk of electric shock

Check that there are no missing of wire slots and terminal protection boards,
and that there is no danger of electric shock.

8.3.45 Check grounding impedance

Use the medical grounding impedance tester to measure the impedance


between the protective grounding foot in the network power outlet and all
accessible metal parts that have been protected from grounding, which shall not
be greater than 0.1Ω.

8.3.46 Check whether the generator low level switch is effective

Manually drain the water in the generator after the equipment is powered off,
and there should be an generator water shortage alarm after the equipment is

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TD-XT-D004-001 V2.19
powered on again.

8.3.47 Check the integrity of equipment and external pipe insulation

Check the integrity of equipment and external pipe insulation, and whether
there is any damage.

8.3.48 Check the level of front and rear door guides and fasten them

Check whether there is slippage, adjust the level of guide rails if necessary,
and check whether there is loosening of fixing bolts.

8.3.49 Check and clean the steam baffle

After the equipment is disconnected, wait for the temperature of the


chamber to drop to room temperature, then remove the steam baffle. Wet a clean
cotton cloth with water and wipe the inner and outer surfaces of the steam baffle
and the chamber surface covered by the steam baffle.

8.3.50 Check and clean all flow-limiting joints (if any)

Check all flow-limiting joints in the piping for foreign objects or blockage after
removal.

8.3.51 Check all valves for leaks

Check all automatic and manual valves of the equipment for leaks when the
equipment is running.

8.3.52 Check if the key switch is in good contact

Check that the key switch wiring.


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TD-XT-D004-001 V2.19
8.3.53 Calibrate the date and time

Confirm the date and time, if there is any error, press the SYSTEM SETTING
key in the main menu screen to enter the auxiliary function screen, click the DATE
AND TIME key in the system setting screen to enter the date and time setting
screen for time calibration.

8.3.54 Replace the door gasket

During the long operation of the equipment, the dust and other impurities in
the environment will enter the sealing tank, resulting in the contamination of the
door gasket, which will affect the sealing performance and service life. Therefore,
it is very important to clean the door gasket and sealing groove regularly.
The following is the removal and installation of door gasket.
When you need to take out the gasket, open the door after stopping all
programs.
To install the gasket into the sealing groove, place the shortest gasket
right-angle edge on the outermost part of the inner diameter of the sealing groove,
mark it with a soft pen, and divide the entire gasket into two equal parts, placing
both marks in the middle of the circular part of the sealing groove. Then fix the
four corners, and then along the flat part of the sealing groove, divided into four
equal parts, and make the excess part as evenly distributed as possible, and then
the gasket is carefully and evenly pressed into the sealing groove, and finally
checked for errors, the installation is complete.

In order to extend the service life of the gasket and achieve


the expected sealing effect, it is recommended that the gasket should be cleaned
once a week. The operation method is: remove the sealing ring, use soap solution

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TD-XT-D004-001 V2.19
to carefully clean the sealing groove, and then dry it with clean cotton or gauze;
gently scrub the ring with alcohol, dry it and put it back into the sealing groove.

8.3.55 Detect temperature, pressure and time parameters

Commission the manufacturer or a qualified third party to test the


temperature, pressure and time parameters, and make a comprehensive
assessment of the equipment according to the test results.

8.3.56 Replace the generator water level gauge gasket (For built-in generator

equipment)

After the equipment is powered off, wait for the generator pressure to drop
to 0.1Mpa, open the generator drain valve and drain the water, then disassemble
the water level gauge to replace the gasket.

8.3.57 Replace all clamp gaskets on the pipeline

After disassembling the clamp, remove the old clamp pad, clean the orifice
and place the new clamp pad squarely and then install the tightened clamp.

8.3.58 Replace the air filter element

The efficiency of air filter cartridge decreases after long time use, which in
turn affects the filter's ability to filter out airborne bacteria and impurities, the
order of filter disassembly and replacement is as follows:
1) Remove the fixed nuts at both ends of the filter first.
2) Rotate the filter, remove the filter housing and take out the filter element
and filter mesh.
3) After replacing the filter element, install it back as it is.

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TD-XT-D004-001 V2.19
8.3.59 Disassemble and clean bolt

Disassemble and clean bolt and replace it if needed.

8.3.60 Clean the printer thermal printer head

1) Loosen the printer head clips.


2) Wipe the printer head with a cotton cloth and alcohol.

8.3.61 Check the integrity of the equipment nameplate

Check the nameplate for defacement and missing.

8.3.62 Calibrate the touch screen

When the touch screen is in use and touch inaccuracy affects normal key
operation, the touch screen should be calibrated.
Touch calibration should be performed in accordance with the following
operations when the device program is not running.
1) Swipe down from the top edge of the screen in any interface, and a
toolbar will appear at the top of the screen.

2) Click the Exit button on the far left side of the toolbar.

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3) Click on the Control Panel button and the Control Panel pop-up window
will appear

4) Click the Touch button, the Touch screen pop-up.

5) Click the start button on the right side of Touch, then enter the
calibration screen.
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6) Press and hold the position on the screen until "Push here" becomes
"ok", and repeat several times.

7) Repeat several times and then return to the Touch pop-up window, click
the Apply button.

8) Touch calibration is completed and the equipment reboots.

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8.3.63 Replace PLC battery

Remove the controller cover, find the battery mounting plate, clean the
battery mounting slot after removing the old battery, and replace the battery with
a new one, the battery type is CR2032.

8.3.64 Replace the heating tube contactor of generator (For built-in generator

equipment)

1) Cut off the power switch in the user's wall power switch box.
2) Remove the old contactor and wiring, and take pictures of the wiring
position and sequence before removal.
3) Replace the new contactor of the same model and specification (or
replaceable model approved by the sterilizer manufacturer), and restore
the contactor wiring and check the wiring diagram according to the photo,
and follow the Manual requirements for wiring fastening parameters.

The equipment must replace the generator heater tube


contactor regularly. The overdue use of the contactor may cause the contactor
to stick, which may cause the heater tube to burn out or cause a fire in serious
cases.

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8.3.65 Leak test

Run the leakage program, the program ends successfully and the leakage rate

is not greater than 0.13KPa/min.

8.3.66 Check and clean the working fluid inlet and cavitation protection port of

vacuum pump, check the suction of the pump, no leakage during operation

After the equipment is disconnected, disassemble the working fluid inlet and
cavitation protection port of the vacuum pump and check if there is any foreign
matter blocking.
When the equipment is running, check whether there is any leakage of the
vacuum pump.

8.3.67 Vacuum pump cleaning and descaling (if any)

1) Wear personal protective items (gloves and protective glasses).


2) Turn off the power.
3) Open the pump cover at the bottom to empty the wire plug, and then
reinstall the wire plug.
4) Disassemble the piping connected to the equipment.
5) Fill the pump body with decalcifier through a connection opening. Use a
10% acetic acid concentrate or other equivalent available decalcifier.
6) Leave the decalcifying fluid in the equipment for at least 30 minutes.
7) Remove the motor fan cover and manually rotate the motor fan so that
the shaft turns in the normal operating direction.
8) Open the lowermost drain plug in the pump cover and drain the
decalcifying fluid.
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9) Flush the vacuum pump with water.
10) Manually start the sterilizer evacuation system and keep evacuating for
1min and keep flushing the vacuum pump.
11) Contaminants will be discharged from the pump with the flushing liquid.

When descaling, be sure to prevent the decalcifying agent from


touching the human body to avoid burning the skin!

8.3.68 Check the integrity and stability of the vacuum pump vibration damping

pad

Check whether there is any obvious vibration or strange sound when the
vacuum pump is working and whether the damping pad is broken when running.

8.3.69 Replace generator water level gauge gasket (For built-in generator

equipment)

After the equipment is disconnected, wait for the evaporator pressure to


drop to 0.1Mpa, open the generator drain valve, drain the water, then disassemble
the water level meter to replace the gasket.

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Chapter IX Others
Any kind of disinfection and sterilization equipment, Whether in the form of

lower exhaust or programmed automatic control, To achieve a reliable sterilization

effect, In addition to the design, manufacturing quality and perfect maintenance

of the equipment itself, the human factors for the success of sterilization are to

correctly grasp the basic knowledge of sterilization and sterilization, to be familiar

with the working principle of the equipment, to strictly follow the operation

specifications of sterilization and sterilization, and to seriously treat each

regulation related to sterilization.

8.1 Self-protection

During disinfection, the staff must have the awareness of self-protection and

take self-protection measures to prevent injuries to personnel caused by

disinfection accidents and improper operation methods.

Sterilization equipment works at high temperature, special attention should be

paid to burns.

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8.2 Guarantee of Sterilization Quality

1) Ensure the cleanliness of sterilized articles

Cleaning is the key to successful sterilization, especially for some

medical supplies that are difficult to clean. Studies abroad have found that

thorough cleaning can reduce the number of bacteria by 3-4 logarithms and

greatly reduce the content of organic matter. If pollutants such as organic

matter cannot be effectively removed, it will greatly reduce the activity of the

sterilization agent, and bacteria hidden in the organic matter are not easy to

be killed by the sterilization agent; Therefore, if the cleaning is not complete,

the whole sterilization process will fail. It must be noted that the cleaning

requirements cannot be reduced by prolonging the sterilization time and

increasing the temperature of the sterilization agent. In order to facilitate and

effectively remove organic matter, it is best to use enzyme-containing

detergent to enhance the cleaning effect. Cleaning includes manual cleaning

and machine cleaning. Manual cleaning is time-consuming and laborious, and

cannot guarantee the consistency of each cleaning. In addition, medical

personnel must wear waterproof masks, blindfolds, gloves, sleeves, hats,

waterproof shoes and aprons during manual cleaning. Machine cleaning

costs a lot, but it can ensure the consistency of cleaning. However, it must be

noted that machine cleaning cannot completely replace manual cleaning. For

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some pipelines, fine instruments and parts that are difficult to clean, manual

cleaning must be carried out. In addition, cleaning equipment must be

cleaned and maintained frequently to avoid machine cleaning failure.

Without proper washing, a high level of disinfection or sterilization cannot

be guaranteed.

2) Water quality control

The hardness of water is divided into two types: first, temporary

hardness is mainly formed by bicarbonate of calcium and magnesium; Second,

the hardness mainly formed by sulfate, nitrate and chloride of calcium and

magnesium cannot be removed by boiling, so it is also called permanent

hardness.

Because disinfection and sterilization equipment works under humid

and hot conditions for a long time, impurities in water, such as dissolved oxygen,

carbon dioxide, hydrogen sulfide, chloride, etc., whether gaseous or particulate,

all produce intergranular corrosion to stainless steel and metal. Therefore, the

PH value of water supply and steam supply for disinfection and sterilization

equipment is required to be between 7 and 7.8, and boiler water and

disinfection equipment water must be treated.

3) Environment of sterilization chamber

 The ground of the disinfection and sterilization room must be flat and
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smooth, with cement ground as the appropriate, with a slight inclination to

the waste water discharge port to keep the operation area clean and dry.

The roof should be equipped with a ceiling to prevent dust from

accumulating. The walls should be flat and clean, and isolated from the

washing, preparation and other studios.

 The discharge ports of waste steam and waste water must go through walls

or be buried in trenches, or be discharged into the atmosphere; Do not

allow residual water and steam to return and invade the room.

 Install ventilation devices at appropriate positions on the top end face of

the wall or ceiling.

4) Preparation and placement of articles

 Dressing fabric should be moderately tight when folding and wrapping to

facilitate steam penetration.

 When the package is discharged on the shelf, a gap of 10mm shall be kept

between them, and the loading capacity shall not exceed 90% of the

volume of the chamber, so as to facilitate the smooth circulation of steam.

 Commercial aluminum lunch boxes and enamel boxes shall not be used to

contain articles to be sterilized, and shall be packed with utensils with vent

holes.

6) Requirements for sterilized articles

 A batch of similar articles should be sterilized as far as possible, and direct


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contact between the equipment bag and the cotton bag should be avoided.

 The volume of articles used for sterilization shall not exceed 30cm×30cm×

50cm.

 The bundle of articles should not be too tight, and the chemical indication

card should be placed in each bag for sterilization protection.

7) Clean sterilization chamber.

When the temperature of the sterilization chamber and shelf drops to close

to room temperature, scrub with neutral detergent, then rinse with tap water, and

finally dry with a cloth that does not fluff.

Clean up the fiber chips and deposits attached to the filter screen at the front

of the chamber to ensure that the vacuum rate, the smooth flow of condensed

water and the temperature indication are consistent with the pressure.

8.3 Detection of Sterilization Effect

Detection of sterilization effect is a necessary means to evaluate whether the

sterilization method is reasonable and whether the sterilization effect is reliable.

Detection methods are divided into three categories: physical, chemical and

biological:

1) Physical mode:

1 Instrument detection: The equipment is equipped with a pressure gauge

to show the pressure of the jacket (if any) and the chamber. And the temperature

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and pressure values of the chamber are displayed on the touch screen, The

equipment is also equipped with a micro printer, which can record the pressure,

temperature and corresponding time values of each sterilization state in the

sterilization process, as well as the properties of the use program, pulsation times,

sterilization time, drying time, sterilization temperature and other parameters. The

sterilization effect can be preliminarily judged by observing whether these values

are consistent with the requirements.

2 Point thermometer detection: The structure of the point thermometer is

the same as that of the thermometer, but its maximum temperature can reach

180 ℃, which needs to be thrown below 50 ℃ when in use. When in use, it is

placed in the center of the sterilization bag, and the temperature of each point is

tested by using a plurality of retention point thermometers. After sterilization, it is

observed whether the displayed temperature value reaches the required

temperature. The disadvantage of this method is that only the temperature can be

displayed, and the duration of the point at this temperature cannot be expressed.

3 Thermocouple detection: The method is to put the electrode of the

thermocouple into the part of the sterilizer to be tested, close the cabinet door

and lead out the wire, analyze the data by the verifier, and display the

temperature values of the tested points in time by the computer. The method can

detect the uniformity of temperature and the stability of sterilization temperature

at each point in the inner chamber of the sterilizer.


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2) Chemical detection method:

1 Chemical indication cards: This type of indication cards can be divided

into chemical indication cards that can be used for pressure steam sterilization

effect detection at 115 ℃, 121 ℃ and 132 ℃. When in use, a chemical indicator

card that can indicate both temperature and temperature duration is put into the

middle of the dressing bag to be sterilized. After one sterilization cycle, the

indicator card is taken out and compared with the standard color for judgment. If

the indicator color is darker than the standard color, the sterilization is qualified,

otherwise, the sterilization is required again.

2 Chemical indicator tape: The tape is coated with adhesive on one side

and chemical indicator on the other. It can be used as an indication to distinguish

"sterilized" from "unsterilized" and can also be pasted on the surface of the

dressing bag as a package seal. After the sterilization is completed, the uniform

blackening of the indicator color can indicate whether the sterilization treatment

has been carried out, thus further proving the possibility of successful sterilization.

The chemical indicator used for testing must be approved by the Health

Department and used within its validity period!

3) biological detection method:

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Biological detection refers to the final detection method that uses living

microorganisms to detect sterilized articles to identify whether all microorganisms

in sterilized articles are dead and to evaluate whether sterilization equipment is

qualified.

 Calibration indicator bacteria: The spores of "thermophilic adipose bacillus",

which are the most difficult to be killed and have the strongest heat

resistance in the world, are used as sterilization indicators.

 Medium: The medium used in the experiment is bromocresol violet

peptone water medium.

 Detection method: Two thermophilic adipose bacillus spore tablets were

put into sterilized small paper bags respectively and placed in the middle of

the standard test package (package size 25cm× 30cm×30cm). The test

package was placed above the exhaust port in the sterilization room. After

sterilization, the standard test package was taken out and put into

bromocresol purple peptone water medium under aseptic conditions. The

medium was cultured at 56 ℃ for 7 days to observe the color change of

the medium. Negative control and positive control were set up during

detection.

 Results: The color of all media did not change, which was determined to be

qualified for sterilization. If it changes from purple to yellow, it is

considered that sterilization has failed.


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 Treatment: If the sterilization is not qualified, the batch of articles can be

temporarily sealed to find out the possible causes of sterilization failure,

and then the sterilization treatment can be resumed. The sterilization

effect of the sterilizer can also be re-detected with the same biological

indicator from multiple or multiple manufacturers of the same

manufacturer. Carefully check the production date, effective date, damage

and contamination of the biological indicator during cultivation.

 Other testing methods approved by the Ministry of Health are allowed to

be used for biological testing of sterilization effect according to their

instructions.

 The equipment shall be commissioned before normal use or after overhaul,

and shall not be put into use until it has passed the biological tests for

three consecutive times.

Physical detection, chemical detection and biological detection have

different purposes and meanings, so they cannot be replaced by each other and

should be used in combination with each other.

Physical detection-can explain the operation status of sterilization equipment

itself, and can intuitively display relevant parameters such as time, temperature,

pressure, etc. in the working process.

Chemical detection-can detect whether the sterilization process has been

completed, can understand the penetration of steam to the package, and can
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provide the first visual inspection at the moment after the sterilization is

completed to assist in judging the sterilization effect.

Biological testing-mainly used for the final judgment of sterilization effect,

but its cost is high and time is long, so it cannot be used per package or per pot.

4) Bauer-Dick test (abbreviated as B-D test)

The B-D test was designed by two Scottish microbiologists J.H. Bowie and

J.Dick in 1963 to test the air exhaust effect of vacuum pressure steam sterilizer.

 Vacuum test chart: Indicator ink is made from a mixture of various

chemicals through a certain carrier. Indicator ink is printed on paper of

special size with certain air permeability through a specific printing method

to form a certain pattern, thus becoming a B-D test vacuum test chart. The

chemical indicator on the test chart is sensitive to residual air and can

detect whether residual air exists in the test package.

 B-D test: This test should be carried out before the first sterilization every

day. In the experiment, the vacuum test chart is placed in the middle of the

test package (disposable B-D test package can also be used), then the test

package is placed at the exhaust port of the sterilization room, the cabinet

door is closed, and the sterilization test is carried out according to the set

sterilization parameters (134 ℃ 4min). After sterilization, the cabinet door

is opened, the test package is untied, the test chart is taken out, and the

test results are observed.


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 Preparation of the test package: The test package consists of 46 ~ 50 cm× 80

~ 90cm pure cotton cloth towels. The cloth towels are folded horizontally

into three layers and then vertically into six layers. Stack the folded cloth

towels one by one to a height of 25cm. When stacking, each layer of cloth

towel is alternately arranged left and right according to the folding side so

that the thickness on both sides is equal. After the cloth towels are

arranged, the vacuum test chart is sandwiched between the cloth towels in

the central layer, then wrapped with the cloth towel, and the outside is

fixed with chemical indicator adhesive tape to form a test bag. The size of

the whole test package is about 27-30cm in length, 23-25cm in width,

25-28cm in height and 4-5kg in weight.

 Results Judgment: The test chart turned black and uniform, i.e. The colors of

the central part and the edge part were the same, indicating that the air

was completely discharged and the sterilizer vacuum system was good,

indicating that it could be used. If the color change of the test chart is

uneven, the color of the central part is usually lighter than that of the edge

part, indicating that the air is not completely discharged and the sterilizer

has poor performance. Only after repair can it be used.

 Note: The cloth towel should be washed at least once before use, but

should not be scalded, because excessive drying will affect the test results;

For reused test bags, the cloth towel must be washed. During continuous
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tests, the bag should be opened every time, the cloth towel should be

dried for 1 hour, and then repacked. Too wet the cloth towel can also affect

the test results. The package should be loose, not too tight or too small.

 Necessary Conditions: Name of Sterilization Package; Sterilization date or

expiration date; The name or code of the equipment checker and packer;

There is a sterilization mark on the seal.

 The results only show the vacuum state of the equipment and the residual

amount of cold air, and do not show whether the sterilized articles are

qualified for sterilization.

8.4 Energy Saving and Environmental Protection

Although the protection of the environment and energy saving in the

operation of the equipment have been fully considered in the design process,

However, you may use this equipment for disinfection and sterilization of special

articles, so you should contact our company in time so that we can make

appropriate adjustments to the procedures you use to reduce consumption to a

greater extent and save energy.

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Appendix
Appendix A Operating Procedures
Appendix B Electrical Drawing
Appendix C Installation Drawing
Appendix D Intensity of Sterilization Factors

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Appendix A Operating Procedures

Applicable to XG1.UCD
 Open the water source supply.
 Turn the power switch of sterilizer to “ON” side, make proper preparation for
operation of the program.
 Open the door, loading the packages into the chamber, and make sure that there is
clearance between every two packages and no packages contacts with inner wall or
door plate.
 Log on and close the front door, select the appropriate sterilization program, start
the program.
 In the course of sterilization, the operator may not get far away from this equipment,
but shall closely observe the operation of equipment. If any abnormal situation is
found, please handle it in time, so as to prevent the occurrence of any accident.
 Monitor the sterilization effect and properly make and retain the record, so as to
ensure the traceability.
 After the sterilization is completed and the pressure in sterilizing chamber returns to
zero, open the door and unloading the packages.
 After taking out the sterilized packages from the sterilizer, put it in an appropriate
place, so as to prevent the secondary contamination.
Works after Operation:
 Open the door, turn the power switch to “OFF” side, and cut off the power supply.
 Discharge the residual water in boiler (or fully discharge the water accumulated in
boiler in accordance with the required interval).
 After the works are completed every day, please keep the inside and outside of
sterilizer clean, clear away all dirt from the chamber, carry out simply maintenance
once a week, and carried out thorough maintenance once a month.
Notices:
 No packages which has been sterilized may be placed together with unsterilized
packages.
 The packages which have been successfully sterilized shall be marked with
sterilization date and qualified sign.

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Appendix B Schematic 1

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Appendix B Schematic 2

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Appendix C Installation Drawing

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Appendix C Installation Drawing

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Appendix C Installation Drawing

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Appendix D Intensity of Sterilization Factors

The temperature of XG1. U pulsating vacuum sterilizer of Xinhua brand was


tested in the sterilization stage,
At 121 ℃, the minimum temperature of small load temperature test in
exhaust program is 121.14 ℃, and the maximum temperature is 122.72 ℃. The
difference between each point at the same time is not more than 2 ℃, and the
maintenance time is 20min.
At 121 ℃, the lowest temperature of full load temperature test of exhaust
program is 121.27 ℃, and the highest temperature is 122.62 ℃. The difference
between each point at the same time is not more than 2 ℃, and the maintenance
time is 20min.
The minimum temperature of 121 ℃ pulsating program small load
temperature test is 121.02 ℃, the highest temperature is 122.95 ℃, the
difference between each point at the same time is not more than 2 ℃, and the
maintenance time is 20min;
The minimum temperature of 121 ℃ pulsating program full load temperature
test is 121.04 ℃, the highest temperature is 122.64 ℃, the difference between
each point at the same time is not more than 2 ℃, and the maintenance time is
20min;
The lowest temperature is 134.03 ℃ and the highest temperature is
135.78 ℃ in the small load temperature test with 134 ℃ pulsating program. The
difference between each point at the same time is not more than 2 ℃, and the
maintenance time is 20min.
The lowest temperature is 134.01 ℃ and the highest temperature is
135.97 ℃ in the full load temperature test of 134 ℃ pulsating program. The
difference between each point at the same time is not more than 2 ℃, and the

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maintenance time is 20min.
The lowest temperature is 132.04 ℃ and the highest temperature is
134.54 ℃ in the small load temperature test with 132 ℃ pulsating program. The
difference between each point at the same time is not more than 2 ℃, and the
maintenance time is 8min.
The lowest temperature is 132.05 ℃ and the highest temperature is
134.64 ℃ in the full load temperature test of 132 ℃ pulsating program. The
difference between each point at the same time is not more than 2 ℃, and the
maintenance time is 8min.

Note: The intensity data of sterilization factor comes from the prototype of
sterilization factor intensity determination and detection.

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