small steam sterilizer - zone medical · 2021. 6. 14. · i hӓtmed small steam sterilizer for...
TRANSCRIPT
Small Steam Sterilizer
User Manual (Internal Water Tank)
Q50B/Q70B
2460
HӓTmed (Wuxi) Co., Ltd V01 version
I
HӓTmed Small steam sterilizer for sterilizing medical and laboratory equipments, The product design conforms
to the YY/T 0646‐2015 standard and is a Class B sterilizer.Process evaluation system according to EN13060.
Do not sterilize any liquid，Violating the use of this product to
sterilize liquids will damage the product and the loads.
:
Symbols Indication Description
Warning
Identifies danger points or conditions and
the correct procedures that must be
followed to avoid injury.
Hot Surfaces Hot items, take care to avoid burns.
Caution
Identifies actions that could damage the
device/component.
Precautions Draw user's attention to important matters.
Symbols on products:
Symbols Description
take care to avoid burns
Manufacturer of medical equipment
Date of manufacture of this device
Serial number
Symbols description
Application
II
Name and address of authorized agent of this product in the European Union.
Service should be performed by qualified technicians only. Observe all local
and national directives related to service and safety standards.
The function and life span of this product are directly related to whether the user follows the operating specifications and maintenance requirements in the installation and use manual.
Manufacturer confirms that this product complies with the European Union
Medical Device Specification.
Draw user's attention to important matters.
Identifies danger points or conditions and the correct procedures that must be followed to
avoid injury.
Liquid sterilization Do not sterilize any liquid
Professionals The operator who use sterilizers and fabric must be got a trained professional.
Power cord and power plug
Do not replace the power cable or power plug.Do not use a damaged power cable or
power plug.
Do not use this product if the power cable or power plug is damaged.The power cable
or power plug must be replaced by a professional authorized by the manufacturer of
this product.
Do not use force on the power cable,be sure to operate the plug itself when plugging
and unplugging.
Make sure the power cable is not knotted。
Do not place the power cable near a heat source.
Do not touch the power cable with a sharp object.
Installation, setup and
commissioning
Installation, setup and commissioning should be performed by a professional
authorized by the manufacturer of this product.
Safety instruction
III
Do not use or operate this product at sites where there is a risk of explosion.
The electrical connection of this product and the connection of the inlet and outlet
pipes should be carried out by professionals.
This product should not be in direct contact with the patient. Place this product outside
the range of at least 1.5 meters (radius) in the treatment area.
If an external printer is configured for this product, the printer should not be placed in
a location where there is a risk of contact with liquid.
Emergency door
opening device Do not use this device to open the door under normal conditions.
Sewage pretreatment
and sterilization
Pretreatment and sterilization of instruments and fabrics should follow the regulations
of the instrument and fabric manufacturers.
Strictly follow the relevant standards for disinfection and sterilization,e.g.WS506‐
2016,WS310‐2016.
Use packaging materials or containers that have been confirmed by their manufacturer
for sterilization.
Sterilization termination
This product terminates abnormally at certain stages of the program,high temperature
steam will emerge from the chamber after opening the door.
The loaded item may not be sterilized when the sterilization is abnormally terminated.
Please note the status of the program showed on the display when it terminates.If
necessary, the loaded items should be repackaged and sterilized.
Remove the loaded item
Do not use strong door opening.
Use the tray handle to take out the tray. Do not touch the sterilized items with bare
hand,including chamber and door cover.
Check if the loaded items is packaged completely after sterilization.If the package is
damaged,please pack instrument or fabric again.
Delivery and transportation
At least 2 people need to move or deliver this product.
Use proper belts.
The shipping box provided by the manufacturer of this product must be used for
transportation.
Sterilization load The load must be sterilized with allowed steam by the manufacturer before it can be
sterilized.
maintenance
Maintenance of this product must be performed by a professional authorized by the
manufacturer.
Please maintain the product at the time intervals specified in this manual.
Must use the accessories supplied by the manufacturer of this product.
IV
malfunction
If the same fault message appears repeatedly in this product, please turn off the power.
Repair must be performed by a professional authorized by the manufacturer of this
product.
Name of sterilization Standard
134 Standard
121 Quick B
Quick S
134+ Fabric
Class of sterilization B B B S B B
Dynamic pressure monitoring √ √ √ √ √ √
Air leak √ √ √ √ √ √
No load √ √ √ √ √ √
Solid load √ √ √ √ √
Small amount,porous,permeable mixed load
√ √ √
Small amount,porous,permeable √ √ √ √
Porous,permeable full load √ √ √ √
B hollow load √ √ √ √ √
A hollow load √ √ √ √
Simple packaging √ √ √ √ √ √
Composite packaging √ √ √ √ √
Dry,solid load √ √ √ √ √
Dry,porous permeable load √ √ √ √
Sterilization Program Introduction
V
TABLE OF CONTENTS
1 Device Description ........................................................................................................................................ 1 1.1 Delivery list ........................................................................................................................................... 1
1.1.1 Standard delivery list ..................................................................................................................... 1 1.2 Product view ......................................................................................................................................... 1
1.2.1 Front view ..................................................................................................................................... 2 1.2.2 Front view ..................................................................................................................................... 2 1.2.3 Side view ....................................................................................................................................... 3 1.2.4 Rear view ....................................................................................................................................... 3 1.2.5 Inside view ..................................................................................................................................... 4 1.2.6 Top view ........................................................................................................................................ 4
1.3 Technical Parameters ............................................................................................................................ 4 1.4 Loading method .................................................................................................................................... 5 1.5 Intelligent controller and control panel .................................................................................................. 5
1.5.1 Operation buttons ......................................................................................................................... 6 1.6 Emergency door opening device ............................................................................................................ 6 1.7 Equipment workflow ............................................................................................................................. 6
1.7.1 Sterilization program ..................................................................................................................... 6 1.7.2 Vacuum test ................................................................................................................................... 7
2 Installation and handling instructions ........................................................................................................... 7 2.1 Unpacking precautions .......................................................................................................................... 7 2.2 Installation site requirements ................................................................................................................ 8 2.3 Device height adjustment ...................................................................................................................... 8 2.4 Connection requirements ...................................................................................................................... 9
2.4.1 Electrical connections ..................................................................................................................... 9 2.4.2 Distilled water connection ............................................................................................................. 9 2.4.3 Wastewater connection ............................................................................................................... 10
2.5 Installation service list ......................................................................................................................... 10 2.6 Handling instructions ........................................................................................................................... 10
3 First time operation .................................................................................................................................... 11 3.1 Startup ................................................................................................................................................ 11 3.2 After startup ....................................................................................................................................... 11 3.3 Open and close the door ...................................................................................................................... 11 3.4 Distilled water injection ....................................................................................................................... 12 3.5 Drainage ............................................................................................................................................. 12 3.6 Sterilization effect verification ............................................................................................................. 13
4 Sterilization program .................................................................................................................................. 13 4.1 Loading items to be sterilized .............................................................................................................. 13 4.2 Select sterilization program ................................................................................................................. 13 4.3 Auxiliary option ................................................................................................................................... 14
4.3.1 Warm‐up setting .......................................................................................................................... 14 4.3.2 Automatic printing ....................................................................................................................... 15 4.3.3 Extra drying ................................................................................................................................. 15
4.4 Running a sterilization program ........................................................................................................... 15 4.4.1 Start sterilization ......................................................................................................................... 15 4.4.2 Program running process ............................................................................................................. 15
4.5 Manual stop ........................................................................................................................................ 15 4.6 Sterilization process completed ........................................................................................................... 17 4.7 Sterile item storage ............................................................................................................................. 18
5 Functional testing and other procedures ..................................................................................................... 19 5.1 Vacuum test ........................................................................................................................................ 19 5.2 B&D test.............................................................................................................................................. 20
VI
5.3 Helix test ............................................................................................................................................. 20 5.4 Drainage program ................................................................................................................................ 21
6 System settings ........................................................................................................................................... 21 6.1 Time setting ......................................................................................................................................... 21 6.2 Date setting ......................................................................................................................................... 22 6.3 Language settings ................................................................................................................................ 22 6.4 Warm‐up setting .................................................................................................................................. 23 6.5 Printing settings ................................................................................................................................... 23 6.6 Extra drying settings ............................................................................................................................. 24 6.7 Water quality testing ........................................................................................................................... 24 6.8 System reset ........................................................................................................................................ 25 6.9 System information .............................................................................................................................. 25
7 Sterilization log ........................................................................................................................................... 25 7.1 Log export ............................................................................................................................................ 26 7.2 Log printing .......................................................................................................................................... 26 7.3 Log interpretation ................................................................................................................................ 26
8 Small steam sterilizr maintenance ............................................................................................................... 27 8.1 Cleaning of items before sterilization ................................................................................................... 27 8.2 Maintenance ........................................................................................................................................ 27
8.2.1 Cleaning and maintenance ............................................................................................................ 27 8.2.2 Regular maintenance .................................................................................................................... 29
9 Failure and common problem ........................................................................................... 错误!未定义书签。 9.1 No information on the display .............................................................................................................. 29 9.2 Large consumption of distilled water .................................................................................................... 30 9.3 Bad drying effect .................................................................................................................................. 30 9.4 No distilled water ................................................................................................................................. 30 9.5 Unable to open the door ...................................................................................................................... 30 9.6 Leakage at the door or dripping underneath ......................................................................................... 31
Appendix 1 Safety device description ............................................................................................................. 31
Appendix 2 Schematic diagram of piping system ............................................................................................ 31
Appendix 3 Electrical schematic diagram ........................................................................................................ 32
- 1 -
1 Device decription
1.1 Delivery list
1.1.1 Standard delivery list
The standard accessories sent with sterilizer are listed in the table below. Please check the list when unpacking.
1.2 Product View
1.2.1 Front View
1.1.1 Standard delivery list
Accessory name Accessory Picture
Q’ty Description
Air level
1
Air level is placed above the sterilizer during installation. Two foot pads at the front is higher than the back end. The angle between the bottom of sterilizer and countertop is around 5‐10°.
Tray
3 Aluminum tray with holes at the bottom for placing sterilized items.
Tray handling
1 Tool to take out the tray
Chamber rack 1 Rack to hold the tray
Fuse
2 220V/16A fuse
Air filter
1 Air filter to ensure that the air entering the sterilization chamber is highly filtered to reduce bacteria and dust entry.
Wastewater pipe
２ Transparent silicone tube for draining waste water(Φ9*6 2M).
Drain connector
（internal tank
only） 2
A joint connecting the drain pipe to the sterilizer wastewater interface
Random Document
Installation and manual
1 Manual book
Product Service Manual
1 User guidance, installation service order, maintenance record
Operation precautions
1 common problems and precautions
- 2 -
Fig 1.1 front view
1.2.2 Side view
Fig 1.2 side view
Door handle
Power switch
Display
- 3 -
1.2.3 Rear view
Fig 1.4 Rear View
1.2.4 Inside View
Fig 1.5 inside view
Wastewater drainage interface A (empty)
Power Switch
Printer interface
Test interface
USB interface
Emergency door opening device
Air filter
Power cable
Safety valve
Wastewater drainage interface B (half drainage)
Cooling fan
- 4 -
1.2.5 Top View
Fig 1.6 Top view
1.3 Technical parameters
parameter name Q50B Q51B Q70B Q71B
External size 570mm*450mm*470mm 680mm*450mm*470mm
Packaging size 688mm*576mm*688mm 806mm*576mm*688mm
Chamber size Φ253mm*355mm Φ253mm*475mm
Capacity of Sterilizer 18 L 23 L
Pressure vessel weight 4.8 kg 6.2 kg
Equipment weight 59.6 kg 71.6 kg 64.8 kg 66.8 kg
Built‐in clean water tank volume
3.8L
Built‐in waste water tank volume
4.5L
Software version V00
Pressure vessel technical indicators
Working pressure is less than 0.25Mpa
Operating temperature:115℃‐138℃
Working voltage A.C 220V±22V, 50Hz±1Hz
Maximum power 2000VA
Fuse 16A
Distilled water tank (Internal)
- 5 -
Working environment pressure
70 Kpa ~ 106 Kpa
Working temperature 5 oC ~ 40 oC
Storage and transportation environment temperature
‐20 oC ~ 55 oC
environment humidity ≤ 85%
Maximum wastewater temperature
100 oC
Maximum noise 70 dB(A)
Electromagnetic compatibility
Compliance with GB/T18268.1‐2010; Works properly in its electromagnetic environment, but does not constitute an unacceptable electromagnetic
harassment of anything in the environment。At the same time, it has the ability to resist electromagnetic interference.
According to GB 4824‐2013，Electromagnetic radiation meets Group 1 Class B requirements.
Standards compliant YY/T 0646‐2015; GB4793.1‐2007; GB4793.4‐2001;
Note 1：The maximum operating voltage range ：198V ~ 242V Note 2: Anti‐electromagnetic interference is the ability of the sterilizer to work properly in the presence of electromagnetic interference
1.4 Loading method
The tray rack is included in the delivery of sterilizer. The space inside the tray rack is a space that can be
effectively sterilized, always use the tray rack when loading items to be sterilized. The tray rack can hold 5 trays or
adapt to thickness of different loads or containers after rotating 90oC.
Fig 1.6 Loading method
1.5 Intelligent controller and control panel
Intelligent controller is the core of small steam sterilizer, In addition to completing operations such as rapid
acquisition, processing, fault detection, and control of the system's real‐time parameters, the controller also
intuitively plots the temperature and pressure versus time curve in the chamber.
The intelligent controller is easy and efficient to operate with LCD screen with 4 buttons.
- 6 -
1.5.1 Operation buttons and Identification
The use of 4 buttons in different situations is as follows:
Button position
（Face up from left
to right）
１ ２ ３ 4
When the program is selected
return Previous option
Next option Select
standby mode Open the door Startup
Program runtime Stop
When setting Confirm
There is an icon in the interface to display the door lock status.
Status Identification Description
Door lock status The status of the door lock: on or off
1.6 Emergency door opening device
Emergency opening is an unconventional way to open the door when sterilizer cannot be powered on due to
other reasons or the safety door failure.Please do not open the door in this way under normal circumstances.
Remove the screw on the emergency protection cover on the back of the product (Fig. 1.4),then using your right
hand to grasp the white plastic disc inside the protective cover,gently pull(distance is about 1CM).At the same
time,use your left hand to lift the door handle up to open the door
1.7 Equipment Workflow
1.7.1 Sterilization program
Sterilization process consists of 3 stages, pre‐vacuum, sterilization, drying. After the program is started, the
user can see the stage of the program running on the interface.
Process name Description
1.Pre‐vacuum
During the stage of pre‐vacuum, the process of evacuating and injecting
steam is proceeded repeatedly, As the mixture of air and steam is
continuously extracted, the air in the chamber is minimized.The number of
this process varies according to the selected program, standard sterilization
procedure repeated 3 times, Helix program and 134+ program repeated 4
times.
2.Heating
After the pre‐vacuum is the heating stage, steam is continuously injected
into the chamber, the temperature and pressure in the chamber rise
continuously until the specified value of the selected program is reached.
- 7 -
3.Holding
After the temperature and pressure reached the set value, holding phase
begins and maintains stable temperature and pressure for a period of time
to ensure that the sterilization effect meets the requirements of the
specification
4.Depressurizatio
n
The pressure in the chamber is released after the holding time is over. At the
same time, the steam in the steam generator is discharged.
5.Drying
After sterilization, the sterilized items are dried. Drying begins after pressure
is released. Under the effect of a high efficiency air filter, the air in the
chamber is always sterile during the drying process
6.Intake
The drying process is also the process of intake, make sure that the pressure
in the chamber returns to environmental pressure at the end of the
program.
1.7.2 Vacuum test
The purpose of the vacuum test is to test the leak rate of the sterilizer. No sterilization of the items in the
chamber during the process. Please run the vacuum test in a cold and dry chamber without loads.
Process name Description
1.Vacuum The air in the chamber is evacuated till the pressure in the chamber reaches the set value of the vacuum test
2.Balancing time After waiting for 5 minutes, the vacuum everywhere in the chamber tends to be uniform.
3. Test holding time
Test holding time is 10 minutes, The device continuously monitors the pressure in the chamber during the period
4.End of test After the test is over, the screen displays the test results: vacuum and leak rate.
2 Installation and handling instructions
2.1 Unpacking precautions
Installation, setup, and commissioning should be performed by a
professional authorized by the manufacturer of this product.
This product is taken out of the box and transported must be operated by 2 people.
Total weight：Q50B 59.6 kg; Q51B 61.6 kg;
Q70B 64.8 kg; Q71B 66.8 kg
- 8 -
Please carefully check the box and take out the device. If the
package is damaged or the equipment is damaged, please contact
an authorized dealer or logistics company immediately.
Please check the packing box and the random accessories inside
the sterilizer. A list of standard accessories can be found in section
1.1 of this manual.
2.2 Installation site requirements
This product should be placed in a dust‐free and dry environment。Surrounding humidity is less than 85%,
Temperature between 5 oC and 40 oC.
Do not use or operate this product at a site where there is a risk of
explosion.
Countertop must be able to support the weight of this product :
Q50B 59.6 kg; Q51B 61.6 kg;
Q70B 64.8 kg; Q71B 66.8 kg
Each surface of the device (except the bottom) must have a gap
of 10 cm outward. Too small a gap will result in heat buildup,
shorten the life of the equipment, reduce the performance of the
equipment and extend the running time of the program.
2.3 Device height adjustment
Take out air level and put it in the horizontal position at the top of the product and adjust the two foot pads at
the front end to make sure the front is higher than the rear side. The angle between the bottom of sterilizer and
countertop is around 5‐10°. It is beneficial to realize the drying of the loads and saves distilled water.
Fig 2.1 Device height adjustment
Rear end Front end
- 9 -
2.4 Connection requirements
2.4.1 Electrical connections
220V/50Hz power supply. The maximum power supply
fluctuation range is 198V ~ 242V.
Use a separate 16A power circuit. Provides 30mA leakage
protection.
Make sure the power cable is not knotted or pressed.
Do not use force to pull the power cable,
Do not place the power cable near a heat source.
Do not touch the power cable with a sharp object.
Do not replace the power cable or power plug. Do not use a
damaged power cable or power plug
Do not use this device if the power cable or power plug is
damaged. The power cable or power plug must be replaced by a
professional authorized by the manufacturer of this device.
2.4.2 Distilled water injection
Open up cover of the internal water tank and Inject the distilled water into the internal water tank through the
water tank deflector, please be noted that the distilled water added should not exceed the height of the water
deflector, generally stored in a standard 12L distilled water tank.Full tank of distilled water can complete up to 20
sterilizations. Please pay attention to the amount of distilled water remaining in the tank to avoid affecting the
normal operation of this device.
Compliance with YY/T 0646‐2015 high quality distilled water as
specified in appendix B or demineralized water because the degree
of formation of rust stains depends on whether the water quality of
the distilled water is up to standard.
Conductivity ≤20μs/cm；
If the inlet pressure is >30 Kpa may cause excess distilled water to
enter the chamber and affect the operation of the device.
In order to prevent the distilled water from being contaminated, the
lid of the distilled water tank must be tightened or tight at all times.
For small steam sterilizer with internal water tank, please drain the
waste water tank before injecting distilled water.
Regularly clean the distilled water tank at least once a month.
- 10 -
This product has water quality monitoring device,it will not work
properly when unqualified water and will give warning that water
quality cannot reach the standard.When you see this message,
please replace high quality distilled water in time.
If you need to use the water purifier, please consult the
manufacturer of this device first.
It is best to tilt and secure all the water pipes connected to the back
of the device are not bent or knotted.
2.4.3 Wastewater connection
For small steam sterilizers without internal water tank, take out the drain pipe from the accessory bag and insert the waste water connection to the back of the device (Figure 1.4).
It is best to tilt and secure all the water pipes connected to the
back of the device are not bent or knotted.
2.5 Installation service list
After installation please carefully fill out the installation service
form in the manual which is useful information for maintenance.
2.6 Handling instructions
This device has to be stored and transported at humidity less than 85% and temperature ‐20oC ~ 55oC. Before transportation, please carry out “drainage program” first and take off all pipes(including distilled
water pipes and waste water pipes),if printer is connected,remove the printer cable.
If the tray rack and tray are placed in the chamber during transportation. Before closing the door,place a foam
pad between the door and the tray holder to prevent the tray frame from being damaged by shaking during
transportation
For long‐distance transportation, the product must be returned to the package in the order in which it was
unpacked, and the package must be sealed.
Please carry drainage program before handling this device
- 11 -
3 First time operation
3.1 Startup
Turn on the power switch, the power switch position is in the lower right corner of the device inside view (Figure 1.4).
Make sure to remove the latex plug from the air filter mounting
hole at the back of the device and install the air filter from the
accessories included.
3.2 After Startup
After startup at the first time, please set up language and carry out pressure test. After the pressure verification
is successful, the initial setting is completed. The date and time can also be set as required. See Chapter 6 system
settings in this manual.
Steps of pressure verification is as follows:
3.3 Open/close the door
Pressure verification Verification is checking …
P: 0.00 Bar
Pressure verification
Pressure verification
successful
Door open to complete pressure verification
press button and open up the door
Wait for calibration and make sure the door is open.
press to select
1–Sterilization program 2 – Test program 2‐ 3 – Sytem setting 4 – File record
- 12 -
Door open up operation：Please press button at standby mode,you will see door lock icon will change
its status on the display to indicted the door is opened. At this time, open the door handle on the right side of the
device upwards by about 90oC and then open the door outward.
Closing operation：Close the door of sterilizer，The door handle is turned down to the end。
When closing the door, please press the door handle down to the
end. The strength required after using for a period of time may
increase
Don’t slam the door at any time.
Failure to comply with the above requirements may affect the
function and reliability of the door lock device
Open the door only when loading and unloading, Keeping the door
closed at other times is beneficial to energy saving
3.4 Distilled water injection
Inject qualified distilled water into the distilled water tank and make sure the water level is between the lowest
mark (MIN) and the highest mark (MAX). Always check the water level in the water tank and replenish distilled
water in time.
Fig 3.1 Inject distilled water
For the sterilizer with internal water tank, please discharge waste
water tank every time before injecting distilled water.
- 13 -
3.5 Drainage
For sterilizer with internal water tank. After using it a few times please take out plastic drain connector and pipe from accessory bag when to discharge the waste water tank. Please insert one end of the drain connector without a black rubber seal into the drain pipe and insert the other into drainage interface (Figure 1.4 and Figure 1.5).
For sterilizer with internal water tank, please empty the waste
water tank before injecting the distilled water.
3.6 Sterilization effect verification
Small steam sterilizer installed or used for 12 months or after maintenance shall carry out B&D test without
load and carry out physical, chemical and biological monitoring with full load.After monitoring is proved successful,
the sterilizer can be used again. Verification of sterilization results shall comply with the requirements of Appendix
E of WS506‐2016
4 Sterilization program
4.1 Loads to be sterilized
Proper loading is a key factor for effective sterilization and drying.You
must also pay attention to the following when loading
The load must be sterilized by the manufacturer if steam
sterilization is permitted.
Packaging materials for packaged sterilization products shall
comply with GB/T 19974 standard.
Sterilized items packed in paper and plastic bags, The paper must
be faced up and laid flat in the tray.
For mixed load for sterilization, fabric is on the top and the metal
is on the lower layer.
There must be a gap between the sterilization bags.
Metal bags and dressing bags cannot be attached together.
The load capacity must not exceed 90% of the chamber capacity.
4.2 Select sterilization program
This product has 7 preset sterilization programs. Please select the appropriate sterilization program
according to the load type and packaging material. The parameter setting of the sterilization program and the typical
load description are as follows. The maximum load of Q50B/Q51B is 6kg instruments or 2kg fabric.The maximum
load of Q70/Q71B is 7kg instruments or 2.5kg fabric.
- 14 -
Table 4‐1 Sterilization program and parameter settings
Name of
Sterilization
T
(℃)
Holding
time
(Min)
Drying
time
(min)
Sterilization load
121 program
121 ＞15 1‐99 a small amount of fabric，Heat‐resistant instrument.
134 program
134 ＞3 1‐99 Mixed load，long and hollow instruments
134+ program
134 ＞3 1‐99 Mixed load，long and hollow instruments
Quick S 134 ＞3 1‐99 Solid instruments and hollow instruments.
Quick B 134 ＞3 1‐99 Wrapped & unwrapped solid instruments
Fabric 121 ＞15 1‐99 Fabric
Select the sterilization program as follows：
Fig 4.1 Select sterilization program
4.3 Auxiliary option
4.3.1 Warm‐up setting
The automatic warm‐up function allows the sterilizer to reach the set temperature before the program is
started to significantly reduce the time required for each sterilization. See section 6.4 for details.
1 – Sterilization program 2 – Test program 2‐ 3 ‐ System settings 4 – File record Press to select
134 program
121 program Quick B Quick S Press to enter
- 15 -
The chamber will automatically heat up to 110 °C when the automatic
preheat setting is turned on. Please be careful of burns!
4.3.2 Automatic printing
Turn on the automatic printing function and the sterilizer is properly connected to the printer to automatically print the sterilization record after the program ends. See section 6.5 for details
4.3.3 Extra drying
Additional drying settings based on user preferences, extend the drying time of the preset sterilization program based on the drying time in Table 4‐1 to achieve good drying results for loads, especially cotton fabrics. See section 6.6 for details.
4.4 Running a program
4.4.1 Start sterilization
After selecting sterilization program,pleaes press to start up program.Sterilizer will ensure that the door
is locked and the water quality of the distilled water is monitored after the start of the program.
Fig 4.2 starting program
4.4.2 Program running process
Sterilization program includes 3 phases,pre‐vacuum,sterilization and drying. The description of each stage is detailed in section 1.7.1 of this manual. The controller monitors the operation of the sterilizer and the temperature and pressure in the chamber in real time and displays relevant information on the screen.
07/25/2017 09:23:58 134 program
134℃/2.1Bar /5Min
T: 25.0℃ P: 0.00Bar Door status
Press to start program
- 16 -
4.5 Manual stop
A running program can be manually stopped at any stage. If the sterilization process is stopped before
the start of drying, the loaded items are not sterilized. If the sterilization procedure is manually stopped after the
start of drying, the loaded items have been effectively sterilized, but not fully dried. In the case of fully loaded
packages, the possibility of wet bags is very high and these items cannot be stored because Because aseptic storage
places high demands on the dryness of the packaged items.
After the program is manually stopped, there may be high temperature
steam coming out and causing burns when the door is opened！
Do not touch the product, loaded items, chamber or door cover
with bare hands.
Be sure to use the tray handle to take the loaded items.
Manually stopping the sterilization process at an earlier stage may cause an
infection！
If the sterilization process is stopped before the start of drying, the
loaded items are not sterilized，The use of these items may
endanger the health of the operator and the patient.
If necessary, the loaded items should be repackaged and sterilized.
If you need to manually stop the current program, please press (Fig 4.3). After manual stop, the screen
displays the program end interface and manually stops the fault information. The intelligent controller is processed
according to the current situation to achieve a safe pressure inside the chamber and other parts of the device also
ensure a safe state. After the device is in a safe state, the controller is allowed to operate the door open button,
the required time and the program running state when manually stopped, usually takes several minutes.
134 program
P: 0 Bar T: 25.0℃ Door status 00:00:00
Press to stop the program
Program stop
The program stops in progress… P: 0.85Bar
- 17 -
Fig 4.3 Manual stop
4.6 Sterilization procedure completed
When the sterilization process ends normally, the program end interface and program running success information are displayed on the screen. If the automatic printing function is set and the printer is connected, the
product will automatically print the sterilization record. Please press to open the door.
Careful burns！
Do not force the door to open. Failure to do so may result in
damage to the product and/or hot steam coming out of the
chamber.
After the sterilization is finished, wait for a while until the sterilizer
is fully cooled before opening the door.
Do not touch any metal surface.
Do not touch the sterilized loaded items, chamber and door covers
with bare hands to avoid being burned.
Be sure to use the tray handle to remove the loaded items.
Balance when removing the tray to prevent the contents of the
tray from slipping.
Damaged packaging devices or items may not be effectively sterilized,
and exposure to these items may endanger the health of the operator or
patient.
If damaged packaging if found, please repackage the item.
Waiting for 5 minutes after sterilization before removing the
loaded items, which is good for drying the sterile items.
The 11th edition (2017) of the correct handling method for
medical device cleaning and disinfection issued by the
international authority AKI, Germany. It is recommended that the
wet bag be judged as having water drops remaining on the
package or in the package after 15 minutes of sterilization.
Physical parameters should be monitored for each sterilization
cycle, record and check process variables. When the sterilization
temperature set in this cycle is 121 ° C, the holding time should be
no less than 15 minutes. When the sterilization temperature set in
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the cycle is 134 ° C, the holding time should be not less than 3
minutes.
Chemical monitoring should be performed for each sterilization
cycle,by observing the color change of the chemical indicator to
determine whether the sterilization requirement is met
compliance with the information and requirements provided by
the manufacturer of the chemical indicator.
Sterilization monitoring shall comply with the requirements of
Annex E of WS506‐2016
The national standards for sterilization,WS310‐2016 stipulate that
the sterilizer operating cycle parameters should be fully recorded
and stored for 3 years.
4.7 Sterile Storage
Sterile package storage time after sterilization varies with packaging material and storage conditions, in full
compliance with the specification. For example, the condition of WS310‐2016 can be stored for up to 6 months.
Packaging requirements and storage conditions please follow WS310‐2016.
Please follow the packaging manufacturer's recommendations or
regulations for the storage time of the sterile package.
Do not store sterile items in contaminated areas.
Sterile items must be stored in a dust‐free, (In addition to water,
other liquids such as alcohol, disinfectants, etc. should also be
avoided) dry temperature suitable environment.
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5 Functional testing and other procedures
5.1 Vacuum test
When first installed, unused for a long time, moved, or periodically tested,vacuum test is recommended to
detect leakage in the system of this sterilizer:
Fig 5.1 Vacuum Test
Vacuum test should be carried out when the system is cooled and
the chamber is dry.
In order to successfully complete the vacuum test,please check
that the door of sterilizer is closed and the cooling water valve is
open before starting the program.
1 –Sterilization program 2 – Test program 3 – System setting 4 – File record
Vacuum test program B&D test program HELIX test program
press to select
07/25/2017 09:23:58 Vacuum test program
15Min
T: 25.0℃ P: 0.00 Bar Door status
press to enter
press to start up
Vacuum test program
P: 0.00 Bar T: 25.0℃ Door status 00:00:00
- 20 -
After the vacuum test program is started, when the pressure in the chamber reaches the standard required
relative vacuum value, the vacuum system stops, and the equilibration time of 5 minutes is turned on. After the
balancing time elapses, the vacuum test is started for 10 minutes. After the test is completed, the system returns
to normal pressure.
After the vacuum test is finished, the system will prompt the result on the program end interface and save the
record in the memory. If the automatic printing function is set and the printer is connected, the test result will be
printed at the same time.
When the vacuum test is passed, the message is “vacuum test success”. Indicates that the system's leak rate
meets the design requirements. Print the information as follows:
‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐
PROGRAM PROPERLY EXECUTED！ Vacuum Test Success！
Leakage rate: <0.13Kpa/min Leak rate：<0.13Kpa/min Your system is steady!
‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ When the vacuum test fails, the message is “Vacuum Test Failed”. Print the information as follows:
‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐
PROGRAM ERROR EXECUTED Vacuum Test Failed！ Vacuum Test Fail!
‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐ ‐‐
If the vacuum test fails, please do not continue to use the product
and contact the manufacturer or authorized dealer immediately.
5.2 B&D Test
B&D test is used to check the steam penetration of this sterilizer to porous permeable loads, such as cotton
fabrics. Select the B&D test in the test program interface (Figure 5.1).
Test methods and test results are judged in accordance with the
information and requirements provided by the test package
manufacturer.
WS310‐2016 requires weekly B&D testing to monitor and save
records
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5.3 Helix Test
The Helix test is used to verify the steam penetration and saturation for A type hollow instruments, such as
dental handpieces. Select the Helix test in the test program interface (Figure 5.1).
Test methods and test results are judged in accordance with the
information and requirements provided by the test package
manufacturer.
5.4 Drainage program
This product allows users to perform drainage procedures when needed. This procedure is used to drain water
remaining in a small steam sterilizer.
When the water in the chamber is obvious after opening the door,
it is recommended to use the drainage program before loading the
item for sterilization. Especially when the program is abnormally
stopped, this situation is easy to occur. Please open the door for
inspection.
Please carry out the drainage program before handling this
product.
6 System setting
Enter the system settings interface (Figure 6.1) for time, date, language, warm‐up, automatic printing,
additional drying settings, and system reset.
Fig 6.1 System setting
6.1 Time setting
The time setting operation is as follows:
1 –Sterilization program 2 – Test program 3 – System setting 4 – File record
Press to enter system setting
Time setting Date setting Language setting Warm‐up setting
Press to enter time setting
press and to set up
time.Press to switch between time,minute and second.After
setting press to exit time setting.
Time setting
10：27：39
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Fig 6.4 Time Setting
6.2 Date Setting
Date setting operation is as follows：
Fig 6.3 Date Setting
6.3 Language Settings
Click the [Language Settings] button to enter the language setting interface (Figure 6.2), select the
language.Press for completion.
Completion
Press to select date
setting.Press to enter date setting.
Time setting Date setting Language setting Warm‐up setting
Press and to set up
date.Press to switch between
year month day.Press to exit setting.
Time setting
07/25/2017
Completion
Press to select language
setting. Press to enter into language setting.
Time setting Date setting Language setting
Warm‐up setting
Press and to select
language setting.Press to exit language setting.
Language setting English Chinese French Back Confirm
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Fig 6.2 Language Setting
6.4 Warm‐up settings
Warm up setting operation is as follows:
Fig 6.5 Warm‐up Setting
The chamber will automatically heat up to 110 °C when the automatic
preheat setting is turned on. Please be careful about burns!
6.5 Automatic printing settings
Automatic printing setting operation is as follows:
Press to select
printer setting. Pressto enter printer setting system.
Date setting Language setting Warm‐up setting
Printer setting
Press and to setup
printer.Press to exit printer setting after completion.
Printer setting Automatic printing: close
Completion
Completion
Press to select warm‐up
setting.Press to enter into warm‐up setting.
Time setting Date setting
Language setting Warm‐up setting
Press and to adjust.
Press to exit warm‐up setting after completion.
Warm‐up setting
Automatic warm‐up： Close Back Confirm
Completion
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Fig 6.6 Automatic print setting
6.6 Additional drying setting
Additional drying setting operation is as follows:
Fig 6.7 Additional drying setting
6.7 Water quality testing
Water quality testing operation is as follows：
Fig6.8 Water quality test settings
6.8 System reset
System reset operation is as follows：
Press to select additional
drying setting. Press to enter to set up additional drying.
Warm‐up setting Printer setting Additional drying setting System reset
Press and to enter into additional drying setting.
Press to exit additional drying setting after completion.
Additional drying setting
Additional drying：close
Completion
Press to select system
reset.Press to enter into system reset.
Additional drying setting System reset
Administrator settings System message
Press to select water
supply setting.Press to enter into water supply setting.
Warm‐up setting Printer setting
Additional drying setting Water supply setting
Press and to set up water supply setting.
Press to exit water supply setting.
Water supply setting
Water quality testing： Close
Back Confirm
Completion
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Fig 6.9 System reset interface
6.9 System Information
System information operation is as follows:
Fig 6.9 System information interface
7 Sterilization Log
The sterilization log records and stores real‐time data for each phase of the sterilization process. The memory
of this product can store up to two years of sterilization records. Sterilization records are named after serial numbers,
such as: 0001.TXT, can be exported through the USB interface or printed by a printer.
Press and to select whether to perform a system
reset. Press to exit after the setting is completed.
System rest
Yes No
Completion
Press to select system
reset.Press to enter into system reset
Press to exit System information interface.
Completion
Water supply setting System reset Administrator setting.
System message
System message MODEL:I‐P‐PRO FW:00.02.19.00 HW:Qx3_V0.2 SN:65252120517050508 Back
- 26 -
7.1 Log export
For long‐term storage of sterilization records, sterilization records can be exported via USB interface to a
computer or portable storage device. Specific operation: Insert the USB flash drive into the USB interface and export
the record as follows. After the export is completed, the interface displays the export completion prompt. Please
remove the USB flash drive.
Fig 7.1 Record Export
7.2 Log printing
When the automatic printing function is turned on and the sterilizer is properly connected to the printer, the
sterilization record can be automatically printed after the program ends. See 6.5 for details on how to operate.
File export Export all records?
Export
1 –Sterilization program 2 –Test program 3 –System setting 4 – File record
按 或 选择
是否导出记录。
按 键进行记
录导出。
File export
Exporting file… Record copy
File export Export completed Exit
Press to exit
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7.3 Log interpretation
The format of the sterilization record for printer output and internal memory storage is as follows.
- - - - - - - - - - - - - - - - Quantus Sterilizer - - - - - - - - - - - - - - - - Program : Quick-program-S 134°C unwrapped Data : 2017.07.12 Start Time : 09:11:29 Cycle : 1 SN : 65252120517050513 Preheat Temper : 95.0°C Conductivity ：11.0us/cm - - - - - - - - - - - - - - - - Program step press temper time bar°C min Start : -0.0469.6 0:00:00 1.Vacuum one Sub press : -0.8772.00:02:26 Steam press: 0.50109.90:05:32 2.Vacuum two Sub press : -0.5289.20:06:32 Steam press: 2.14134.30:11:51 - - - - - - - - - - - - - - - - Keep : 2.14134.30:11:51 Keep End : 2.17135.0 0:16:51 Realse : 0.10 105.6 0:18:27 Dry : 0.10105.60:18:27 Dry End : -0.9190.3 0:22:27 Ventile : -0.1492.3 0:22:39 Finish : -0.1492.3 0:22:39 - - - - - - - - - - - - - - - - PROGRAM PROPERLY EXECUTED! Temperature : 134.7+0.2/-0.4°C Pressure : 2.14+0.02/-0.03bar Sterilization : 0：22:39 End Time : 09:34:08 Hardware Version: Qx3_V0.2 Software Version: 00.02.16.19 - - - - - - - - - - - - - - - -
Product Number Program Date Start Time Running times Serial number Preheating temperature Distilled water conductivity Vacuum twice, recording pressure, Temperature time information Sterilization holding stage Sterilization holding completion Depressurization Drying start Drying completion Inlet Sterilization completion Final report, recording sterilization temperature,pressure, program running time and completion time
Hardware and software version
- 28 -
8 Small Steam Sterilizer Maintenance
8.1 Cleaning of loaded items prior to sterilization
Before sterilization, the load of handpiece must be thoroughly cleared.
Dust and contaminants separated from the load will cause blockage of filters, valves and
piping, therefore, the sterilization load without cleaning is not allowed to enter the device
for sterilization.
Follow all regulations for cleaning, disinfection, and sterilization provided by the device
manufacturer.
8.2 Small steam sterilizer maintenance
8.2.1 Cleaning and maintenance
Regular cleaning and maintenance can effectively extend the life of the sterilizer and ensure a good working
condition.
Maintenance item Maintenance cycle Special tool Maintenance operation
Replace the seal Sterilize 1000 times Open the door and check whether the seal is
deformed or wrinkle, etc. If it is deformed or
wrinkled, it is recommended to replace it.
Seal maintenance 2 weeks Remove the seal.Please rinse it with water
and wipe it dry with a soft cloth.After that
replace the lid.
Note: Pay attention to the installation direction of the seal (the narrow side is close to the chamber cover and the wide side is close to the chamber).
Door lock maintenance Sterilize 1000 times lubricating oil A small amount of lubricating oil is sprayed
on the left side of the lid through the hole (A
indicated), and the outer surface is wiped by
a paper towel.
Cleaning distilled water
tank Sterilize 300 times
Wash it with clean water.
Clean the filter at both
ends of cooling water
inlet pipe.
Sterilize 100 times
Unscrew the nut at both ends of the inlet
pipe and rinse it with clean water.
A
- 29 -
Clean the filter at
the bottom of the
sterilization chamber
Sterilize 200 times
Wrench Unscrew the filter with a wrench and wash it
with clean water.
Clean trays Sterilize 100 times Rinse it with clean water, if stained, clean it
with toothpaste
Sterilization chamber Every week
Wipe the sterilization chamber with a clean
and wet medical cotton cloth,then wipe the
chamber with a clean and dry medical cotton
cloth
8.2.2 Regular maintenance
WS310‐2016 and WS506‐2016 require a comprehensive
maintenance of the small steam sterilizer every year to ensure
good equipment working condition and sterilization effect
Maintenance and take care of this device must be performed by a
professional authorized by the manufacturer.
9 Faults and common problem handling
9.1 No display on the screen
Faulty description： The display does not light up normally when the sterilizer is turned on.
Solution：
Check if there is power in the main power outlet
Check if the power plug of this product is plugged in.
The screen still does not appear, please contact professional distributor authorized by HӓTmed.
9.2 Large consumption of distilled water
Faulty description：Distilled water consumption is much larger than the specified amount
- 30 -
Solution：
Please check if the foot pad adjustment is correct. Under normal circumstances, the front side is
slightly higher than the back side.
Open the door and check if the filter at the bottom of the sterilization chamber is blocked.
None of the above can help reduce the consumption of distilled water, please contact professional
distributor authorized by HӓTmed.
9.3 The drying effect is not good
Faulty description： Drying cannot achieve satisfactory results
Solution：
Please check if the foot pad adjustment is correct. Under normal circumstances, the front side is
slightly higher than the back side.
Open the door and check if the filter at the bottom of the sterilization chamber is blocked.
Please check if the load exceeds the maximum loading capacity(especially textiles) and if the load
is placed correctly in the chamber(do not touch the wall of the pressure chamber directly) and if the
standard trays and tray rack are used for loading.
Activate automatic warm‐up.
Open the left side cover and check if the filter is clogged
None of the above can help improve the effect of drying, please contact professional distributor
authorized by HӓTmed.
9.4 No distilled water
Faulty description：No distilled water
Solution：
Please check if there is water in distilled water tank.
Please check if the distilled water pipe is bent or knotted and inserted into place.
9.5 Unable to open the door
Faulty description： The door cannot be opened even if the emergency button is activated.
Solution:
Please check if the air filter at the rear side of sterilizer is blocked
Take off side cover,unplug the silicone tube connected to the air filter solenoid valve and discharge
the negative pressure inside the chamber.
When you hear the exhaust sound gradually weaken until it disappears, you can open the door.
- 31 -
Return the silicone tube to the original position and clamp. Turn on the vacuum test to check for
leakage.
9.6 Leakage at the door or dripping underneath
Faulty description： Air leakage and water dripping are obvious.
Solution：
Please check if the seal is installed correctly(the long side with the word "H" is exposed outside).
Please check if the seal is damaged.
Appendix 1 Safety Device Description
Preheating system over temperature protection switch: The preheating system has an over‐temperature
protection switch that automatically disconnects the preheating system power supply circuit when the temperature
exceeds the limitation of protection switch threshold temperature to realize the protection function of the
preheating system.
Steam generator over temperature protection switch: The steam generator has three temperature
switches.The protection switch that automatically disconnects steam generator power supply circuit when its
temperature exceeds threshold temperature.
Pressure relief valve: When the pressure inside the chamber is 1.3 times greater than the working pressure,
the pressure relief valve will automatically open in order to keep the pressure inside the chamber within a safe
pressure range.
Appendix 2 Schematic diagram of piping system
- 32 -
Piping system schematic
Appendix 3 Electrical schematic diagram
Small steam sterilizer electrical schematic diagram