Manual Book XG1.DM

®
XG.1.DM Model
PulseVacuum Sterilizer
Operation and Manual
Shandong Xinhua Medical Instrument Co., Ltd.

Introduction ................................................................................................................ 1
Chapter 1 General ..................................................................................................... 2
Chapter 2 Basic Introducton ...................................................................................... 4
Chapter 3 Installation ……………………………………………………………… 6
Chapter 4 Preparation before sterilization………………………………………..11
Chapter 5 Operation………………………………………………………………. 14
Chapter 6 Maintenance……………………………………………………………16
Chapter 7 Routine and Emergency Maintenance………………………………...17
Shandong Xinhua Medical Instrument Co.,Ltd.
Introduction
1. The use of operation and maintenance manual:
The operation and maintenance manual is an essential part of the equipment, which can offer users
the documents as followings:
a) General introduction about the equipment.
b) Installing and handling the equipment correctly and reasonably.
c) Operating and using the equipment correctly and reasonably.
d) The routine maintenance of the equipment and other attentions.
e) Remind the users pay attention to the safety issues.
2. The keep of the operation and maintenance manual:
The operation and maintenance manual must be kept well. No matter where the equipment
goes, the manual must keep together with the equipment.
Safety logo explanations
Warning: The cases possibly cause serious personal injury or equipment
damage.
Caution: The cases possibly cause light personal injury or equipment
damage.
Attention: The cases possibly cause operation failure or incomplete sterilizing.
1
Chapter 1. General
1.1 Manufacture identification materials
Address: No. 7 Taimei Road, Zibo New & Hi-tech Zone, Shandong, P.R. China.
Post Code: 255086
1.2 Equipment basic identification data and label
Manufacture enterprise license number:

20100024 for instrument Shandong food and drag administration
Manufacturer sanitation license number: 0286 Shandong sanitation and fire control
characters (2003) 0286 No.
Product registration number: 2570229 for instrument Shandong food and drag
administration (approved), 2008
Execute Standard: YZB/ Shandong 0155-2008
Passed the authorization of ISO9001 and ISO13485 international quality system.
Technical parameter:
Design pressure: -0.1/0.28MPa Leakage rate:≤0.13KPa/min
Design temperature: 150 ℃ Sterilizing water: Distilled water or pure water
Rated working temperature: 134 ℃ Degree of Temperature uniformity：≤±0.5℃
Maximum working temperature: 0.23MPa

Specification Overall dimension（mm） Power： Diameter X Depth Volume（L）
(mm):
3850 W697×L968×H1537 220V 13 KW φ380X510 60
3870 W697×L968×H1537 220V 13 KW φ380X710 80
5070 W702×L1000×H1700 220V 13 KW φ500X710 135
5090 W702×L1250×H1700 220V 13 KW φ500X950 185
1.3 After-sell service commitment
In the warranty period, if there is something wrong with the machine, our company will provide
technical support or on-site maintenance for free.
After the warranty period, our company will provide high quality service at a price just cover the
cost.
2
Commitment: Once received your application for service, we will offer you satisfactory solution
in 24 hours.
1.4 Matters need attention
1. Before open the package of the equipment, please check whether the package is integrity.
We advice you to keep the packing material well because you may reuse it later. After unfold the
package, please check whether the autoclave has somewhere damaged. If any, please judge and
record the damage degree, for example, panel scratch. At last, please check the packing list and
examine whether the accessories are complete. If you find some problems, please immediately
contact with the after-sale service department (0533-3585253) of our company.
2. Please operate the machine strictly obey the procedure introduced in the operation and
maintenance manual. If the autoclave cannot operate normally, please first refer the fault
analysis table in the manual and try to solve the faults; if you cannot solve the faults, please
immediately feed back the faults to after-sale service department of our company. If you can
provide us the detailed description about the breakdowns of the autoclave and the model and
quantity of the parts probably need to change, our company will appreciate it very much.
3
Chapter 2 Basic introduction

2.1 Appearance
,
P1 P2
unlock lock
2.2 Basic performance introduction
 Microcomputer as the control center, having powerful function, reliable performance
 Touch screen display, powerful communication function between man and machine, easy
to operate, audio-visual display.
 Temperature, pressure and time can be displayed dynamically on the touch screen,
operating process status and alarm information can also be shown on the touch screen.
 Independent steam generator equipped, heating rapidly, uniform and high thermal
efficiency
 Adopting pulse vacuum technology to exhaust the air in the chamber thoroughly, can ensure
the saturation level of the sterilizing medium and also ensure the autoclave up to effective
sterilization in a shot time.(The C series autoclaves without vacuum pump use positive
pressure to exhaust the cool air)
 Vacuum drying ensures the perfect drying effect for the dressing and instrument(The C
series autoclaves without vacuum pump adopt high temperature drying method )
4
 Having BD test, PCD test and leakage test program; Vacuum leakage rate ≤
130Pa/min(The C series autoclaves without vacuum pump there is no such programs)
 0.22μm air filter ensures the air turn back to the chamber is asepsis air, which can avoid
recontamination. (The C series autoclaves without vacuum pump there is no such
configuration)
Requirements on environmental conditions
It should be placed in clean, dry, shady room with ventilation and low temperature difference.
1. room temperature 5℃—40℃
2. The highest relative humidity: 85%
3. The allowed range of voltage vibration:±10%
4. Pressure Atmosphere: 70~106 kPa
Safety device
The XG.1.DM equips following safety devices:
 Over temperature auto protection device: the power will be cut off when the temperature over
rated value.
 Door safety interlock device: the sterilizer start the program and turn on the power only when
the door closed correctly; the door can not open when there’s pressure in the chamber.
 Over pressure safety valve: the safety valve open when the pressure is too high.
 Over pressure alarm: The touch screen display alarm when the main body pressure is too high
 Low water position alarm device: when the water position lower than rated, the power will be
cut off and the alarm information will be shown.
 Electric circuit safety: DC to control overload protection, AC to control short circuit

protection.
5
Chapter 3 Installation
Machine unloading:
Pay attention to the following:
 Don’t stand under the crane;
 Use qualified crane;
 Pay attention to operators’ safety.
Checking:
 After unpacking，check every parts of the machine and make a record, if any problem contact
us by phone.
 Check carefully the links and fastening parts after a long distance transportation, if there is
loosening, make the fastening for them.
Positioning and pipeline connection
Installation should be done under the instruction of specialist by special workers.
3.1 Preparations and requirements before installation
 Ground space required: Considering the operation and maintenance of the equipment,
distance between the wall and the sides of the autoclave should be no less than 300mm. The
height of room should be no less than 2.9m. At least 1.5 meters for the operation end.
 Groundsill: If installed on the ground , the ground surface must be tamped and planished. If
on the second floor, users must consider whether to strengthen the floor or not according to
idiographic condition.
6
 Airiness and dispel heat: In order to assure the equipment work normally and be in
comfortable working condition ,Users must fix a suited airiness system that controlled the
temperature in the range of 15 ~35℃ and humidity below 85% around the autoclave.
 Electrical source: 3 phases with five wires, 3 of them are active line, one is zero line (light
blue) and one is ground line (yellow and green), power source capacity and mains load should
be more than that required for the machine. Also a power box is required on the right or back
wall of the equipment, in which a 3 phase breaker and a one phase breaker are needed.
To ensure person and equipment safety, users must join a wire with the ground. Users
must reliably join the wire marked “ground “in the control cable with ground.
3.2 Cautions:
1. Installation is not allowed in a place of conductive particles, corrosive gas, inflammable
gas.
2. Installation should avoid places with possible electrical shock and vibration.
3. Places of high temperature, high humidity or accessible to rain are not suitable for
installation.
4. Places of high magnetic intensity are not allowed, either.
5. Autoclave uses absolute pressure control, please adjust the relevant parameters when it is
used in highland area.
Pay attention on electrical safety
3.3preparation before adjustment

3.3.1 Before the adjustment, check the connectors, plugs and the connectors of water inflow and
out flow if they corrected link.
7
3.3.2 Apply to XG.1.DM series
3 phase electric motor is used on the vacuum pump, dismatching phase consequence with
power source may occur for the first installation or reinstallation of the machine.
Solution: Turn off power, exchange any two active lines, make connection again and try till
the pump can work effectively.
3.3.2 Apply to XG.1.DM series
Tap water is cycling for the vacuum pump as the working medium, pressure 0.05-0.10 MPa,
temperature: ≤25℃. Start the machine and measure current value on each line of the three from the
pump with clip-on ammeter. If the measured current is much different from the rated value for the
pump, circulation water flow should be adjusted (speed and pressure) usually decreased.
3.3.3 In the first time of running the autoclaves, the injection pump must be filled( if equipped),
to avoid burning out the pump.
3.4 Operating Instructions

3.4.1：operating
（1）Enter into starting up picture and click landing.
图3
8
The system has been set administrator, process technician and 8 operators, the password
of administrator and process operator is 149, the administrator’s Operating authority is the
highest.
P4 P5
P6
Picture 4-6 are the logging in pictures of administrator, process technician and 8 operators
（2）Parameters setting:
 Operators: Can modify the passwords of operator, for example log in operator 1#, then
modify the new password,. Operator can only choose and start the programs.
9
 Process technician: can modify the passwords of process technician, can modify the
parameters of sterilization procedure (as picture 7, 8), can modify the sterilization
temperature, pulse times, pressure limit inside the chamber, cooling temperature and drying
time. Picture 7 is the standard features no need to reset.
图7 图8
 Administrator: has the highest operating authority, can modify the parameters (as picture 9),
can modify the printing parameters: print interval, F0 print, language, report printing.
Administrator can also modify the password both of process operator and operators.
P9 P10
（3）Option program and start
Choose the correct program ( as picture 10) XG.1.DM series do not have the
10
vacuum programs, choose the program then enter into the start parameters (as picture
11), then click start.
P11 P12
（4）System maintenance:
After landing as administrator, click the button of maintenance, enter into time set (picture 12),
modify the time and save, click the button of back. MAC、IP have to set only monitor under the
computer, not the standard features.
（5）Manual operation:
Manual operation only can be used by process operator and administrator (as picture 13). Click
the button “auto” system switch to manual operation; click each part to modify the status. “B” is
vacuum pump as the picture shows, but XG.1.DM series do not have vacuum pump valve, recycling
water valve and Circular valve. Please notice heating pipe DR1 and heating film DR2 are forbidden
to stay in manual status for long time.
11
图 13
（6）If the user’s area is not the standard a standard atmospheric pressure, please contact service
engineer to adjudge the parameters.
Chapter 4 Preparation before sterilization
Preparation for the instruments
The being sterilized articles must be washed before put into the sterilizer, in order to avoid the
rested things on the articles damaging the sterilizer and themselves. For example: blood and other
impurity.
At the same time we make idiographic references:
① The rested things on the instruments that need sterilize should be washed firstly.
②We suggest use washer, purified liquid and distilled water to wash the instruments.
③ Pay attention to the following before placing instruments into the sterilizer tray:
 Instruments should be placed uniformly in the tray, away from each other, overlapping is not
allowed, in order to prevent unqualified sterilization and drying.
 Make sure that the instruments not of the same metal (stainless steel, carbon steeled.) are
separated and placed in different trays.

12
 In case carbon steel instruments are placed in stainless steel trays, the tray should be lined
with a towel or paper-wrap before placing the instrument. There should be no direct contact
between the carbon steel and the stainless steel trays.
 Wrapped instruments should be packed in material, which promotes drying, with good gas
permeability such as autoclave bag, autoclave paper, muslin towels.
④Place at least one sterilization indicator in each tray.
⑤ Vessels must be upside down with openings downwards or side-wards.
Preparation for the Tubing
Clean tubing and rinse with pyrogen free water. Ensure that both ends of the tubing are open, without any
sharp bends, twists or kinks.
Preparation for the Dressing
13
Place packs upright on trays. They should not touch the chamber walls
Water preparation
Water quality for sterilization:
 Conductivity is less than 15μS/cm
 2mg/l Bleacher content is less than 2mg/l
 PH value:5—7
 Rigidity: less than 0.02mml/l
Attention:
 Water should be in accordance with requirement to be used like: distilled, purified
water, otherwise blockade in the pipe may occur and damaging on the solenoid valve
as well as the sterilizer chamber.
 Work medium “steam” must be generated from pure water thus to prevent steam
source contamination.
 In the first time of running the autoclaves, the injection pump must be filled( if
equipped), to avoid burning out the pump.
14
Chapter 5 Operation
5.1 Operated process:

1) Turn on power switch, wait till water filling and preheating completed ny a hint on the
screen, then open the door, load materials to be treated into the trays and close the door.
2) Select a proper cycle according to the material to be sterilized:
3) Program types and default parameters
Code Type Temp. of Ster. Time of Ster. Time of drying Pulse
1# Fabric 132 600 480 3

2# Instrument 132 600 600 3
3# Rubber 121 600 480 3
4# Rapid 132 210 480 1
5# liquid 121 1200 0 0
6# Preheating 121 210 210 1
7# User-defined 132 600 480 3
8# User-defined 132 600 480 3

9# Lumen 132 600 480 3
10# BD 134 215 480 3
11# PCD 134 215 480 3
12# Leakage Vaccum test: maintain stage 300s, test stage 900s
13# Drying 134 0 900 0
The items of liquid has to be unsealed, XG.1.DM series do not have the vacuum programs and pulse
stages
4) Choose proper program, then press “start/stop”, the door is locked automatically, the
program starts to run, the non-liquid programs have stages, they are: “preparation”, “pulse”(apply to
XG.1.DM), “Heating up”, “Venting”, “drying”, “end” and the liquid programs have stages, they are
“preparation”, “replacement”, “Heating up”, “Venting”, “drying”, “end” so on.
15
5) During the running of program, click the button of numerical value then can Real-time monitor
the running times in the screen, Visual review on the relative parameters for different stages on the
screen is available.
图 14
6) The system will alarm and stop operation automatically when there is “overheating”, “over
pressure” or something abnormal. Make sure the pressure is in safe range ±10kPa,the buzzer loud,
the screen shows “press Stop” then open the door.
When the screen shows “end” stage lights and buzzer loud, can open the door to take out items. If
the screen shows “ low temperature alarm” but the program does not stop and completely finished,
which means the program has adjusted the sterilization flow automatically and finish.
7) Close the door, turn off the switch and cut off power.
Exit while running:

It is forbidden to open the door by force during operation, if there is a need of exit, please click
numerical value, then click the button of exit. Till there is a pressure balance in and out of the
autoclave and the temperature reach to opening requirement, then open the door.
Chapter 6 Maintenance
16
In order to ensure the autoclave work in the favorable condition，and reduce the trouble time to a
minimum, the operations in this chapter must be followed.
Caution: Before starting, ensure the electric cord is disconnected and there is no
pressure in the autoclave.
Daily:
 Clean the door gasket with a soft cloth or a sponge.
 Use a gauze with cleansing agent and water to clean the wall and bracket of autoclave
 Clean and get rid of furring in autoclave chamber
 Supplies pure water or distilled water timely, To prepare for the next Sterilization.
Weekly
◆ Clean the cover with soft cloth.
 Take down the door gasket, clean seal groove, then wipe it with clean paper or gauze.
Clean the door gasket and seal groove with alcohol. Put it to the sealed groove after it is dried
 Clean the filter spool
Monthly
 Check the open and close door. Removed door handle, add lubricate grease on the door
bolt.
Yearly
 Tighten the tie-in and check communication state by professional electrician once a
year.
 Check safety valve
 Check the water level detection device in switcher

Every 5 year
Check the interlock device
17
Chapter 7 Routine and Emergency Maintenance

Notice:
Do the maintenance and repair work according to the instruction or under the guidance of
professional, do not do it by oneself.
Lifting and carrying:
1. Cut off the power
2. Disconnect the pipelines to the water tank.
3. Lifting and carrying should be done by several people
Faults Analyze
After switch on, when the screen display the mark of alarm and the buzzer alarmed,
the printer will print the alarm name and code, click the button of the screen to check the
information and click the button of ensure, then check the faults, can not start the program without
confirm the alarm.
Phenomena Reasons Correct Operation

1.The power indicating
1.1 Air switch trip 1.1 Switch on
light doesn’t light when
1.2 Main switch is broken 1.2 Change the main switch
power is turned on.
2.1 Thermostat for dry heat 2.1 Restore the thermostat after
protection is not restored. cooling down.
2. “Dry heating” of
2.2 Serious leakage from the 2.2 Fasten or replace safety valve or
generator
safety valve or joints joints.
2.3 No water in the generator 2.3 Check the water level detector
3.1 The door is not closed in the
3.1 Close the door firmly and try
correct position
3. Alarm of “ door open” again.
3.2 Door travel switch is not in
3.2 Adjust the door travel switch.
position.
4.1 Air flow magnetic valve is
4.1 Clean the magnetic valve
4. Alarm of “over heat” not sealed
4.2 Check the PT100 inside the
inside the chamber 4.2 Temperature probe PT100
chamber
trouble.
18
Phenomena Reasons Correct Operation
5.1 The PT100 transducer inside
5. Alarm of “transducer 5.1 Check the circuit and reconnect
the chamber circuit is broken
is broken” inside the 5.2 Check the PT100 inside the
5.2 Temperature probe PT100
chamber chamber
inside the chamber trouble.
6.1 assist heating controller is 6.1 Check the circuit and replace the
6. Over heating of the short circuit controller
chamber wall 6.2 Temperature probe PT100 of 6.2 check the PT100 of the chamber
the chamber wall trouble wall
7.1 The PT100 transducer of the
7.1 Check the circuit and reconnect
7. The transducer of the chamber wall circuit is broken
7.2 Check the PT100 of the chamber
chamber wall is broken 7.2 Temperature probe PT100 of
wall
the chamber wall trouble
8.1 The pressure transducer inside
8.1 Check the circuit and replace the
the chamber is broken
pressure transducer
8. Over pressure inside 8.2 Temperature probe PT100
8.2 Correct the PT100
the chamber trouble.
8.3 Clean the filter and the magnetic
8.3 the magnetic valve is not
valve
sealed
10.1 Inflow filter is blocked 10.1 Check the inflow filter element
10.2 Water level transducer is 10.2 Replace the water level
9. Water injection over
broken transducer
time
10.3 Check the injection pump (if 10.3 Feeding water or replace the
equipped) injection pump( if equipped)
12.1 Steam inlet valve is plugged
10. Alarm of “low or vent valve leak 12.1 clean the magnetic valve
temp.” 12.2 low upper limit of chamber 12.2 Adjudge the upper limit
pressure
11.1 The connection of float is
11 Water level detection 11.1 Check the connection
incorrect
error 11.2 Replace the float
11.2 The float is damaged
12.1 Will alarm till reach the normal
12. Water shortages
12.1Water feeding automatically level, before start the program have
alarm
when reach the low level to ensure the alarm otherwise can
not start any programs
13 Can not start the
13.1 Close the door 13.1 Close the door
programs when the door
13.2 Interlock trip is not firmed 13.2 Check the tirp
is open
14.1.The connection between the
14. Power switch
screen and the main board is 14.1 Reconnect the screen
indication lamp is on but
broken 14.2 Replace the screen
screen lamp doesn’t light
14.2 The screen is broken
19
7.3 Remove the cover of autoclave
Steps as follows:
Raise the cover upwards， remove the side cover.
7.4 Check the safty valve
Tab
Safety valve
Safety valve
joint
Main safety valve(0.28MPa) Generator safety valve(0.30Mpa)
In order to prevent the safety valve from blockage, every month, under ordinary usage, it is
necessary to allow the steam pressure to escape through it.
1. Operate a sterilization cycle according to the manual
2. Allow a pressure of approximately 0.21Mpa to build up in the chamber.
3. Pull the ring of the safety valve using a screwdriver, and lift the safety valve for 2 seconds.
4. Switch off the power supply to interrupt the operation, and exhaust steam from the chamber.
5. Wait until the pressure goes down to zero, then open the door
7.5 Change te safety valve

This operation should be done only by professionals
1. Remove the fixing screws and take down the safety valve from the base.
2. Replace it with a new one (be sure the valve opens at a pressure between 0.25 MPa-0.26Mpa).
3. Testing all the work process.
20
7.6 Replace the heater

This should be done only by professionals
1. Take down the back cover of autoclave
2. Take down the wires on the heater of steam generator.
3. Remove the heater
4. Replace the damaged one with a new heating element.
5. Reconnect the wires.
6. Install the back cover of autoclave.
7. Testing all the work process.
7.7 Cleaning the electrical magnetic valve
1. Remove the outer cover of the autoclave
2. Pull out the stainless press slip on top of the electrical magnetic valve with a screwdriver.
3. Pull up the ring coil of electrical magnetic valve.
4. Open the valve body with the spanner.
5. Clean the sundries on the valve center with clean water.
6. Restore the electrical magnetic valve.
21
Hexago
nal nut
Remove
Follow the lift
steps ， remove the
nut then take out the
spool.
7.8 Cleaning for the water feeding filter and drainage filter
1. The water feeding filter is used for preventing dirt enter into the steam generator.
2. The drainage filter is used for preventing enter into the inside pipeline and the magnetic
valve
3. Remove the net and gland of filter with wrench
4. Clean the net of filter with pure water
22
5.Re-install the filter
7.9 Replace the water level detector
Caution: Be sure power is cut off

1. Remove the back cover of Autoclave.
2. Remove the connection wires from the detection device.
3. Take off the detector.
4. Replace the damage one with a new water level detector.
5. Re-install the detector and connect the wires.

6. Restore the back cover.
7. Test all the cycle procedures.
23
24
25
TCV3850/3870 OUTSIDE DRAWING

697 1000
1537
circulating water inlet
circulating water drain

steam generator water inlet
chamber exhaust
steam generator drain
26
T CV5 07 0/ 50 90 outl ook

+10 +8
1000(1250) 0 702 0
Screen
+10
800(1050) 0 A
Sealing door^
outl et S team In let In let

关
of o utle t of of pu re
c onne cto r ci rcu lat ing w ate r
开
circ ula tin g

w ate r
压力变送
器
wat er
1630
cover
Filter
真空泵
Fi lter
+30
1420(1670) 0
A
Ou tlet valve
900
100?
27

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®

Operation and Manual

Shandong Xinhua Medical Instrument Co., Ltd.

1. The use of operation and maintenance manual:

the documents as followings:

a) General introduction about the equipment.

b) Installing and handling the equipment correctly and reasonably.

c) Operating and using the equipment correctly and reasonably.

d) The routine maintenance of the equipment and other attentions.

e) Remind the users pay attention to the safety issues.

2. The keep of the operation and maintenance manual:

goes, the manual must keep together with the equipment.

Safety logo explanations

Warning: The cases possibly cause serious personal injury or equipment

Caution: The cases possibly cause light personal injury or equipment

Attention: The cases possibly cause operation failure or incomplete sterilizing.

1.2 Equipment basic identification data and label

Manufacture enterprise license number:

Design pressure: -0.1/0.28MPa Leakage rate:≤0.13KPa/min

Design temperature: 150 ℃ Sterilizing water: Distilled water or pure water

Rated working temperature: 134 ℃ Degree of Temperature uniformity：≤±0.5℃

Maximum working temperature: 0.23MPa

1.3 After-sell service commitment

technical support or on-site maintenance for free.

1.4 Matters need attention

contact with the after-sale service department (0533-3585253) of our company.

Chapter 2 Basic introduction

2.2 Basic performance introduction

 Microcomputer as the control center, having powerful function, reliable performance

to operate, audio-visual display.

pressure to exhaust the cool air)

130Pa/min(The C series autoclaves without vacuum pump there is no such programs)

recontamination. (The C series autoclaves without vacuum pump there is no such

Requirements on environmental conditions

1. room temperature 5℃—40℃

2. The highest relative humidity: 85%

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

4. Pressure Atmosphere: 70~106 kPa

The XG.1.DM equips following safety devices:

 Electric circuit safety: DC to control overload protection, AC to control short circuit

 Use qualified crane;

 Pay attention to operators’ safety.

loosening, make the fastening for them.

Positioning and pipeline connection

Installation should be done under the instruction of specialist by special workers.

3.1 Preparations and requirements before installation

used in highland area.

Pay attention on electrical safety

3.3preparation before adjustment

the pump can work effectively.

3.3.2 Apply to XG.1.DM series

3.4 Operating Instructions

time. Picture 7 is the standard features no need to reset.

computer, not the standard features.

to stay in manual status for long time.

Chapter 4 Preparation before sterilization

Preparation for the instruments

At the same time we make idiographic references:

allowed, in order to prevent unqualified sterilization and drying.

separated and placed in different trays.

between the carbon steel and the stainless steel trays.

permeability such as autoclave bag, autoclave paper, muslin towels.

④Place at least one sterilization indicator in each tray.