Dmax-N AutoClave

Operator,s Manual

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 Contents

1．Introduction .....................................................................................................................................
1. Important Explanation ......................................................................................................................
2.1 Disclaimer ...............................................................................................................................
2.2 Attentions ................................................................................................................................
2.3 Structure of equipment ........................................................................................................
2.4 System interface ...................................................................................................................
2.5 Setting menu ........................................................................................................................
2.6 Main bactericidal factors and strength: ..................................................................................
2.7 Sterilization principle: ............................................................................................................
2.8 Killing microorganisms ..........................................................................................................
2.9 Symbols ...............................................................................................................................
3. Installation .........................................................................................................................................
3.1 Environmental Requirements .................................................................................................
3.2 Equipment placement .............................................................................................................
3.3 Connecting waste water tank ...............................................................................................
3.4 Fill the tank with pure water ................................................................................................
3.5 Pump drainage exhaust ........................................................................................................
3.6 Preparation before use .........................................................................................................
3.7 Transportation of equipment ...............................................................................................
3.8 Equipment storage ...............................................................................................................
3.9 Safety device description .....................................................................................................
3.10 System Settings ..................................................................................................................
3.10.1 Set the time .............................................................................................................
3.10.2 Number of cycles ....................................................................................................
3.10.3 Level .......................................................................................................................
3.10.4 Screen Setting ............................................................................................................
3.10.5 Water Quality Setting ................................................................................................
3.10.6 Sterilization record ....................................................................................................
3.10.7 Beep Volume .............................................................................................................
3.10.8 Unit no ....................................................................................................................
3.10.9 Operator Settings .......................................................................................................
3.11 Data output .........................................................................................................................
3.11.1 Sterilization data printing: card sterilizer built-in printer, can automatically print
sterilization parameters, printing as follows: .......................................................................
3.11.2 Sterilization curve output： ......................................................................................
3.11.3 Output of sterilization record sheet: ..........................................................................
3.12 Permission to illustrate ......................................................................................................
4．Handling Instructions ......................................................................................................................
4.1 Using Methods of the Cassette ...............................................................................................
4.2 Drying Board .......................................................................................................................
4.3 Preparation and Placement of the Instruments to Be Sterilized .............................................
4.4 Weight Reference of the Instruments .....................................................................................
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 4.5 Select sterilization cycle ......................................................................................................
5．Maintenance ....................................................................................................................................
5.1 Regular Cassette Cleaning ......................................................................................................
5.2 Storage Tank Cleaning ...........................................................................................................
5.3 External Cleaning ...................................................................................................................
5.4 Air Filter Replacement ...........................................................................................................
5.5 Seal Ring Replacement ........................................................................................................
5.6 Water Quality Requirements ..................................................................................................
5.7 Printing Paper Replacement ................................................................................................
5.8 Maintenance Manual ..............................................................................................................
6．Common Failures and Solving Methods ........................................................................................
7．Quality Assurance ...........................................................................................................................
8．Technical Specifications .................................................................................................................
9 Parts List ............................................................................................................................................
10. Electromagnetic Compatibility .......................................................................................................
Appendix ...............................................................................................................................................

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Manufacturer information

The product name

AuToClave
Manufacturing enterprise SHINVA Medical Instrument co. .LTD

The registered address No.7 Taimei Road, Zibo New & Hi-Tech Zone,
Shandong, P.R. China

Production address No.7 Taimei Road, Zibo New & Hi-Tech Zone,
Shandong, P.R. China

Product model Dmax-N

The technical requirements Shandong Food and Drug Administration

(Approved) 2015 No.2570386

Production license number Manufacturing Permit from Shandong Food and Drug
Administration No.20100024

Registration certificate no. Shandong Food and Drug Administration

(Approved) 2015 No.2570386

The enterprise standard Q/0303SXH219-2015《AuToClave》

Health license number luweixiaozhengzi（2003）no.0286

After-sales service unit SHINVA Medical Instrument co. .LTD

Contact way Post Code：255086

Service Phone：0533—3581573

Technical Consultation：0533—3580725

Fax：0533—3588673

Website：www.shinva.net

E-mail：shinvakqyl@126.com

Creation date 2018.12.22

Version V 1.1

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1．Introduction

Congratulations on choosing Dmax-N AuToClave, which is a portable desktop

pressure steam sterilizer with four sterilization cycles, meeting the sterilization needs
of steam resistant instruments.

This instruction manual consists of detailed information about device installation,

operation and maintenance. To protect your AuToClave for long-term and safe
operation without trouble, please read this manual carefully before operation and keep
it properly for future reference. In order to operate this product as designed, please
follow the instructions in this manual for operation, maintenance and parts
replacement. We will make changes to the contents of this manual at any time to
reflect the upgrading of the product. Without prior notice.

Application range: For the rapid sterilization of reusable instruments of dental

department

Contraindications: None

Production date: See product nameplate.

Product operator: Medical staff passing the special training.

Note: Sterilizable items include a variety of ophthalmic, dental, and other medical
devices that are designed to withstand high-pressure steam that can withstand
autoclaving, but do not include liquids, dressings, biomedical waste, and
steam-tolerant Articles made of materials that are sterilized without the inclusion of
articles may result in incomplete sterilization or damage to the pressure steam
sterilizer, and all consequences are the responsibility of the customer. If the device is
not used in accordance with the manufacturer's specifications, it may damage the
device.
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1. Important Explanation
2.1 Disclaimer
Only the pure water [conductivity] can be used in the Dmax-N AuToClave. The
water filtered simply and the tap water are not allowed. The warranty is not applicable
for the device in case that the non-pure water is used.
Only designated dealers are eligible to provide spare parts and after-sales service
for your Dmax-N AuToClave. The company will not undertake any responsibility for
any incidental or special loss, including profit loss, commercial loss, economic loss or
the loss caused by personnel injury, in case that the device is repaired by other
unauthorized person or the spare parts not manufactured by the company are used.
The parts replacement or maintenance by non-professional person is not allowed!

2.2 Attentions
Do not open the cover or put any objects into the body without permission, it
otherwise will damage the AuToClave or endanger the operator. If the device will be
suspended for a long time, please disconnect the power. And turn on the power and
operate in compliance with the instruction manual before reuse. Do not disassemble it
without permission. All warranties will be invalid in case of disassembling the device
privately. Any change to device is not allowed since such action is possible to violate
the safety regulations. The company will not undertake any responsibility for the
unacceptable sterilization or operator danger resulting from such change. And the
failure caused by such change is not in the scope of warranty.
If you have any other questions, please contact：

Service line：0533—3587720

Technical consulting：0533—3587720

Fax：0533—3588673

Company website：www.shinva.com

Email：sales@shinva.com

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2.3 Structure of equipment
1

1.LCD screen 6

2.Radiator cap
2
3.Rocker switch
4.printer
5.USB interface
6.Sterilization box
7. Power outlet
8. Machine foot
3
9. Exhaust pipe interface
5
10.air filter
4
11.Safety valve

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10

9 8

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2.4 System interface

Sterilization procedure Setting

alarm record

start button

Program selection area

2.5 Setting menu

Click Settings to enter the menu

2.6 Main bactericidal factors and strength:

This equipment uses moist hot steam as a bactericidal factor.
1. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 121 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 15min (including the semi-period sterilization time l0min + penetration time
5min), and the biological indicator is sterilized and grown aseptically to meet the
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requirements of the "Disinfection Technical Specifications".
2. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 121 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 15min (including the semi-period sterilization time l0min + penetration time
5min), and the sterilized Bacillus stearothermophilus spores artificially contaminated
on the tooth of the hemostat is aseptically grown to reach the "Disinfection Technical
Specification" Qualification requirements.
3. After 5 repeated test results, it shows that the Xinhua Dmax-N type card
sterilizer is set according to the full cycle sterilization procedure, the working
temperature is 121 °C, the sterilization time is 20 min, and the sterilization
temperature and sterilization are performed. Time to test. The results show that the
minimum temperature is 121.3 ° C, the highest temperature is 123.7 ° C, and the
sterilization maintenance time is 15 min, which meets the requirements of the
"Disinfection Technical Specifications".
4. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 134 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 3 min (including the semi-period sterilization time 2 min + the penetration
time lmin), and the biological indicator is sterilized and grown aseptically to meet the
requirements of the "Disinfection Technical Specifications".
5. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 134 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 3min (including the semi-period sterilization time 2min + penetration time
lmin), and the sterilized Bacillus stearothermophilus spores artificially contaminated
on the hemostasis of the hemostasis are aseptically grown to achieve the "Disinfection
Technical Specifications" Qualification requirements.
6. After 5 repeated test results, it shows that the Xinhua Dmax-N type card
sterilizer is set according to the full cycle sterilization procedure, the action
temperature is 134 ° C, the sterilization time is 4 min, the sterilization temperature
and sterilization Time to test. The results show that the minimum temperature is
134.1 ° C, the highest temperature is 136.4 ° C, and the sterilization maintenance time

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is 4 min, which meets the requirements of the "Disinfection Technical
Specifications".
7. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 134 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 5min (including the semi-period sterilization time 4min + penetration time
lmin), and the biological indicator is sterilized and grown aseptically to meet the
requirements of the "Disinfection Technical Specifications".
8. After 5 repeated test results, the Xinhua Dmax-N type card sterilizer is set to a
sterilization temperature of 134 °C according to the semi-cycle sterilization procedure
under the condition that the sterilizer cabinet is loaded at full load. The sterilization
time is 5min (including the semi-period sterilization time 4min + penetration time
lmin), and the sterile infection of the Bacillus stearothermophilus spores artificially
contaminated on the hemostasis of the hemostatic clamp is aseptically grown to
achieve the "Disinfection Technical Specifications" Qualification requirements.
9. After 5 repeated test results, it shows that the Xinhua Dmax-N type card
sterilizer is set according to the full cycle sterilization procedure, the action
temperature is 134 ° C, the sterilization time is 8 min, the sterilization temperature
and sterilization Time to test. The results show that the minimum temperature is
134.1 ° C, the highest temperature is 136.3 ° C, and the sterilization maintenance time
is 8 min, which meets the requirements of the "Disinfection Technical
Specifications".
2.7 Sterilization principle:
This equipment adopts a specific process to discharge the cold air in the sterilizer
room, and takes saturated wet and hot steam as the sterilization factor. Under the
environment of high temperature, high pressure and high humidity, the sterilization of
articles that can be penetrated by steam can be realized according to the combination
of pressure and time.

2.8 Killing microorganisms

Kill or remove all microorganisms from the media.

After removing the cold air in the inner room, the sterilizer takes saturated wet
and hot steam as the sterilization factor and realizes the sterilization of articles that
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can be penetrated by steam under the combined action of certain temperature and time.
All the preset process parameters of the equipment are set under the load described in
the procedure, with the thermotropic fatty liver bacillus spores or microorganism with
the same performance under specific resistance (see the relevant national standards
for details) as the microorganism representative that can be sterilized.

Note 1 ： When the microbial resistance that may be infected by the

sterilization load is greater than the standard agreed resistance (such as prion), it
is necessary to adjust the sterilization temperature, sterilization time and other
relevant process parameters according to the characteristics of specific
microorganisms, and can only be used after the confirmation of the
corresponding process.

Note 2：The killing ability of bactericidal factors on agreed microorganisms

can be effectively guaranteed only when the equipment and related facilities are
under normal working conditions. Equipment failure, external connection
system failure, improper loading of sterilized load and other factors may affect
the killing effect of bactericidal factors.
Note 3 :when the sterilized load changes, the operator shall verify whether
the sterilized load is applicable to sterilization of the equipment before carrying
out relevant operations, otherwise it may cause unpredictable damage to the
equipment or load!

2.9 Symbols

Danger May cause equipment failure

Start Important note

Stop Be careful burns

Be careful to get an electric shock

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3. Installation
3.1 Environmental Requirements

The environment will affect the machine’s normal running, so a suitable location
is important for installation.

● Temperature and Humidity

The suggested temperature and humidity are 15℃~25℃（59℉-77℉）and 25％

~70 ％ respectively. Glare and heat source (such as a vent or a radiator) should be
kept far away from it.

● Space

Don’t cover or block the vent or openings. The top, sides and back should keep a
minimum distance of 5cm with the wall or other partitions.

● Ventilation

The machine should work in a clean, dust-free environment.

● Worktable

A flat, damp-proof instead of tilted worktable is required.

● Electromagnetic Environment

This product has been tested to conform to electromagnetic radiation standards.

Though it has no radiation effect, it may be influenced by radiation emitted form other
equipment, so it is suggested that this machine be installed far away from potential
interference sources.

● Power Source

A ground wire is indispensable. The permitted voltage range is labeled on the

back. A multi-plug socket is not allowed. The voltage regulator should be sole and
can not be shared with other electric appliances.

3.2 Equipment placement

Follow these steps to place the device on the workbench：
● Adjust the three adjustable foot bases to keep the device high in front and low in
back, which can be judged by the gyroscope in the system. Adjust the device to
keep the dots in the screen at five o 'clock. This can ensure that the card sterilizer
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 will sterilization box of residual water drainage. Please refer to 3.10.3 for
specific steps.
● Note: click the setting button, select horizontal adjustment and open the
gyroscope display interface to observe the current horizontal status of the
device.
● All the 4 feet should touch the surface of the worktable to ensure the equipment’s
stability.
3.3 Connecting waste water tank
The waste water bottle is used to collect the waste water which is converted
from steam from the sterilization box.
Connect the waste water bottle as follows:
1. Insert one end of the exhaust pipe into the interface at the back of the card sterilizer
and push as far inside as possible to ensure a stable connection.
2. Cut off the exhaust pipe to an appropriate length according to the site conditions.
3. Insert the free end of the exhaust pipe into the hole on the waste water bottle cap,
and be careful not to distort the exhaust pipe.
4. Remove the waste water bottle cap and the copper spiral condenser together.
5. Fill the waste water bottle with tap water to the tank volume 1/5 (about 1.5l).
Reinstall the waste water bottle cap and condenser. Please empty the waste water
bottle frequently to avoid the water in the bottle becoming stale (adding low
concentration chlorine disinfectant in the waste water bottle can prevent this situation.
Please make it according to the requirements of the disinfectant manufacturer. Every
time you empty a waste water bottle, you refill the tank.
6. The waste water bottle should be as close as possible to the card sterilizer. It is
recommended that the waste water bottle be placed in the cabinet under the card
sterilizer. The exhaust pipe can be guided out by leaving a small hole (8mm in
diameter) at the top of the table.

3.4 Fill the tank with pure water

Please ensure that the use of pure water, non-pure water impurities and
additives will lead to water quality alarm, and display on the LCD screen.
If there is a water quality conductivity tester, please test before water
injection.
Follow these steps to inject water:
1. Open the clean water tank cover on the top of the card sterilizer.
2. Slowly inject pure water into the water purifier (up to 5 liters for empty water tank
and 2 liters for water shortage alarm), and the volume of the water tank is about 5
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liters. Tap water is strictly prohibited. When filling water, prevent water from
splashing out.
3. After refilling the water, please cover the water tank cover in time to prevent other
liquids or substances from entering.

3.5 Pump drainage exhaust

Follow the following steps to drain and exhaust the water pump of the equipment:
1. Move the card sterilizer to the edge of the table. The front foot seat shall be about
12mm from the edge.
2. Lift up the left front corner of the card sterilizer and remove the drain pipe from the
clamp at the bottom of the body.
3. Gently pull out the pipe so that its free end can be put into a container of water.
4. Inject pure water into the purifier.
5. Remove the plug at the free end of the drain pipe and let the water flow out. When
water continues to flow out, replug the drain opening with a plug.
6. Lift the left front foot of the card sterilizer and push the drain pipe back to the
original place at the bottom of the sterilizer.
Make sure the plug in the drain pipe is firm and watertight.
After installation, please run the packaging device cycle twice before
sterilizing the device. For further requirements, please refer to chapter 3.6,
preparation before use of card sterilizer.

3.6 Preparation before use

When the card sterilizer is installed and used for sterilization of the instrument,
the packaging instrument should be circulated twice to ensure the normal operation of
the machine. After the operation, remove the cooled sterilization box, clean the inner
surface of the sterilization box with a low fiber flocculation cloth, rinse thoroughly

13
with tap water and dry for backup use.

3.7 Transportation of equipment

Empty the clean water tank before carrying the card sterilizer. Follow these steps:
1. Place a water container under the card sterilizer.
2. Drain the water in the clean water tank with a drain pipe (see chapter 3.5, pump
drainage and exhaust).
3. Remove residual water in the water purifier with an absorbent towel.
4. Tighten the adjustable foot base at the bottom of the card sterilizer.
5. Pack the card sterilizer and all accessories with the original packaging materials.
6. Apply for transportation insurance and specify the transportation temperature.

3.8 Equipment storage

1. AuToClave during storage, should ensure that tank and pipeline system is dry, no
traces of water, then stored in no more than 80% relative humidity, atmospheric
pressure of 50-106 kpa, temperature is 10 ℃ ~ + 50 ℃ environment.
2. Do not put the card sterilizer in the place of overheating, high temperature will
shorten the life of electronic devices in the card sterilizer, and make the internal
structure of some deformation or change.
3. Do not put the card sterilizer in the place that is too cold, otherwise when the
instrument is suddenly used and the temperature rises, it is easy to cause some
unqualified sterilization phenomenon, and the low temperature will also harm the
equipment itself.

3.9 Safety device description

Dmax-N type pressure steam sterilizer is equipped with a safety pressure relief
valve at the rear. When the pressure is greater than the design pressure, it will be
automatically pushed open by the pressure and exhaust pressure will be released, so as
to avoid excessive pressure causing the box body to be unable to be drawn out or
damage to the peripheral structure and potential danger to human body. The
microswitch at the bottom of the card slot of the card sterilizer is fully pressed before
the sterilization program can be started. In order to avoid the box body is not fully
inserted, resulting in air leakage or even scalding users, in the micro switch is not
fully pressed, the program is unable to start.

3.10 System Settings

3.10.1 DATE/TIME

1. 
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2. Select Settings one by one, and click 01 time setting. On the time setting interface,
use the keyboard keys to change the time. After the change is completed, click back to
the previous button to return to the setting interface.
3.10.2 BRIGHTNESS

1. 
2. Select Settings in turn and select 02 Brightness to adjust the screen brightness of
the device. We can adjust the screen brightness as required.
3.10.3 GRADIENTER

1. 
2. Select Settings in turn, select 03 level adjustment, and open the
gyroscope level display interface. Adjust the height of the foot of
the equipment and adjust the center dot of the gyro to the correct
position (five o 'clock in the direction of the blue center dot) to
ensure the normal discharge of the equipment.
3.10.4 CYCLE HISTORY

1. 
2. Select Settings in turn. Select 06 sterilization record to enter the sterilization record
query interface.
3.Query: the sterilization record interface can query the detailed sterilization history
information.

Output: sterilization record can also be saved by double-clicking the screen output to
U disk.
3.10.5 BUTTON VOL.

1. 
2. Select Settings one by one, select 05 beep volume to enter the interface to select
whether to open the touch screen sound.
3.10.6 MAINTENANCE

1. 
2. Select Settings in turn and select 06 Maintenance to enter equipment sterilization
parameter setting.
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Attention!

The default administrator password is 888888.

3.11 Data output

3.11.1 Sterilization data printing: card sterilizer built-in printer, can automatically
print sterilization parameters, printing as follows:

3.11.2 Sterilization curve output：

Double-click the graph area on the screen, and the graph will be automatically saved
to the USB, and the.bmp file will be generated.

3.11.3 Output of sterilization record sheet:

Open the sterilization record, enter the sterilization record table to view, double-click
the table in the U disk to generate excel file.

3.12 Permission to illustrate

1. Maintenance personnel authority，The password：888888.

4．Handling Instructions
4.1 Using Methods of the Cassette

Be careful of the burning metallic part when trying to pull out the sterilizing
box (cassette) after sterilization, because some steam still exists in the box.
Cassette Opening
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1. Move backward the lifting handle ( ) of the box.
2. Put your hands on two sides of the lifting handle.
3. Slot your index fingers into the groove next to two sides of
the lifting handle and put the thumbs on the thumb pads.
4. Move thumbs downward and index fingers upward until the
cassette lid is opened.
5. Lift up the lid until it is separated from the base plate and
then put it aside.

●Cassette Closing

1. Slot the flashboard on back of the box lid into the groove on
the base plate.

2. The flashboard will occlude with the groove as the box

lid is closed.

●Cassette Insertion

1. Hold the hand shank of the cassette with one hand and
lift the lifting handle with the other hand.

2. Insert the back part of the cassette into the machine and
then put the lifting handle to the front of the cassette.

3. Push the cassette into the machine levelly and lightly

until there sounds a click.

Don‘t insert the cassette forcibly or the internal components will get damaged.

●Cassette Taking-Out

1. Hold the hand shank of the cassette with one hand and pull it out horizontally.

2. Hold the lifting handle with the other hand and lift it out lightly when the cassette is
partly taken out.

3. Put the cassette on the smooth worktable.

· Cassette Insulation

The cassette should be kept insulated when the machine is not being used.
Hold the hand shank and extract the cassette for 15 mm to 20mm.

4.2 Drying Board

17
Dmax-N 5L Small Steam Autoclave enhances the
drying process of wrapped instruments with the drying
board. And the net plate is designed as the bracket of
unwrapped instruments. An absolute wrapped
instruments bracket is not needed. The bracket can hold
10 drying boards horizontally or vertically laid. 5 drying
boards are provided for one piece of machine, if you
want more, please order from our company.

Please install and adjust the drying board with the

following steps:

1. Hold the board and make the fixing hook below it slightly forward tilted.

2. Insert the fixing hook among the meshes of the unwrapped instruments bracket.

3. Every fixing hook has a slim slot. Move the board to make the bracket meshes
firmly touch the end of the slot.

4. Let go the board.

5. Prepare and place the instruments to be sterilized.

4.3 Preparation and Placement of the Instruments to Be Sterilized

Please read carefully the suggestions from the instrument manufactures before
sterilization with this machine.

· Instruments Washing

All the instruments must be thoroughly cleaned before being put into the
sterilizing box, because dirt and impurities will affect the sterilizing effect and
damage both the instruments and the sterilizing box, and even the whole machine. If
lubricant exists on instruments, it must be wiped up.

Unwrapped Cycle

Lay the instruments on the bracket of the base plate and don`t make them touch
each other to ensure the steam get to all parts of the instruments and to speed up the
drying process.

Don`t accumulate instruments in the sterilizing box, or the process will be

impeded.
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 Wrapped Cycle

Put the instruments into autoclave bags according to the manufacturer’s

requirements. Lay the instrument brackets towards one direction in the sterilizing box
to unsure wrapped instruments can be put about 6mm above the bottom of the
sterilizing box. Put the instruments on the bracket and make sure they are not
overlapping. The entire wrap should be dry.

It is advised to use plastic or paper autoclave bags instead of those made of

cloth. Lay the instruments loosely in the sterilizing box to make steam penetrate
all parts of the instruments.
The wrapped instrument bracket can hold a maximum of 10 autoclave bags and
the total weight should be less than 1.5 kilograms.
Rubber And Plastics Cycle

The following materials can be sterilized by the Dmax-N Small Steam Autoclave:
nylon, polycarbonate, polypropylene, acetal, teflon, polysulfide, silicon rubber,
polyester, and so on.
When putting rubber or plastic objects into the sterilizing box, make sure
there is enough room among the instruments, and between the instruments and
the box walls to ensure steam can get through all the parts of the instruments
and to speed up the drying process.
The following materials are not allowed to be sterilized with this machine:
polyethylene, ABS, styrene, acrylic acid, cellulose, PVC, latex, neoprene and
similar materials.
If uncertain about the material or composition of the instrument to be
sterilized, please connect with its manufacturer, lest the instrument or this
machine should get damaged.

Heavy Duty Unwrapped Cycle

Textile, liquid and biomedical wastes can not be sterilized by this machine.
Unwrapped instruments can not keep sterile once exposed to the air. If sterilization
storage is needed, please put the instruments into autoclave bags according to the
instrument manufacturer’s requirements and run the wrapped instrument circulating
procedure until the air drying process is finished.
Periodic Monitoring
Chemical indicators suitable for steam sterilizers should be put inside and
outside of every sterilized bundle or object. Besides, biological indicators are also
advised to use weekly to make sure whether the instrument is sterile or not.
19
Please read carefully the instruction manual of the indicators or directly connect with
the manufacturer to learn how to process, use and place the indicators.
Please use the indicators with the following steps:
1. Put the indicators into the sterilizing box.
2. Sterilize the objects by this machine.
3. Wait until the circulating process is finished and the LCD screen displays
“Finished”.
4. Take out the indicators and make further processing according to the instruction
requirements.
In case sterilizing failure exists the following steps are first to be done:
1. Don't use this machine to sterilize other objects until the sterilizing effect becomes
normal.
2. Make sure you have selected proper indicators.
3. Make sure the instruments in the sterilizing box are not overlapping. If they are,
relocate them according to the rules in the previous section of this chapter.
4. If there is still no improvement, cease using it and connect with our company for
help.
4.4 Weight Reference of the Instruments
Instrument Name About the weight
scissors 30g（0.96ozt）
Teeth cleaning machine 20g（0.64ozt）
tweezers 15g（0.48ozt）
dental handpiece 40～60g（1.3～1.9ozt）
The tray 230g（7.23ozt）
The dry plate 55g（1.76ozt）
Printing mold 15～45g（0.48～1.5ozt）
Note： This table is just for reference. Please read the instruments’ instructions
for accurate data.
4.5 Select sterilization cycle
Dmax-N 5L Small Steam Autoclave is designed with 4 circulating procedures.
Those procedures are for sterilizing a particular kind of instruments each. Instruments
in the sterilizing box should not be overlapping or the steam will not entirely touch
the surfaces of the instruments. And this point is important. The air drying procedure
for bacteria filtration will start automatically as the sterilizing process is finished. The
drying procedure can last for one hour and it can be stopped at any time.
Unwrapped instruments can not keep sterile once exposed to the air. If
sterilization storage is needed, put the instruments into autoclave bags according to
the instrument manufacturer’s requirements and run the wrapped instrument
circulating procedure until the air drying process is finished.
Sterilizing requirements and circulating diagrams of different kinds of

20
instruments are introduced below. Weight reference for correct circulating load of all
kinds of instruments has been listed in chapter 4.4.
1、

Select cycle


2、 
Select start



3、

 select√Start the sterilization cycle

4、In the sterilization cycle interface, you can select the lower three different keys for
different operations. The three buttons are sterilization information, alarm record and
stop button from left to right.

Viewing the
Running
Statussterilizati
on cycle of
detailed
information and
critical parts of 21
the operation
 Select the key to observe Select the key to observe When sterilization is completed or
the current sterilization the current equipment failure occurs, select the key, then
cycle of detailed fault alarm reason, alarm select the √ ,and wait for a few
information and critical date and time seconds to exit the sterilization
parts of the operation cycle.

1. UNWRAPPED
This procedure is designed to sterilize metallic instruments whose weight is less than
1 kilogram, such as pincers, drill needles, dental scalers, tweezers, etc. The
sterilization cycle consists of three sterilization procedures
Note: naked leakage procedure 1 is recommended for sterilization of
superemulsion handle.
The sterilization of dental treatment mobile phone is recommended to use naked
leak procedure 3 for sterilization
Please refer to the requirements of 4.1 and 4.3
2. WRAPPED
procedure is designed to sterilize solid or cavity-owned metallic instruments
which can weigh 1.5 kilograms and are wrapped with autoclave bags (paper/paper or
paper/plastic). A dental handpiece is also suited. The sterilization cycle consists of
two sterilization procedures.
Note：Package 2 sterilization procedure is recommended for endoscopic surgical
instruments。
Please refer to the requirements of 4.1 and 4.3
3. PLAETIC
This procedure is designed to sterilize solid or cavity-owned metallic instruments
that are unwrapped and weigh about 0.4 kilogram. The material products listed in the
chapter Preparation and Placement of the Instruments are suited. sterilization cycle
consists of two sterilization procedures.
Please refer to the requirements of 4.1 and 4.3
4.HEAVY LOAD
This procedure is designed to sterilize larger-load metallic instruments which can
weigh 1.5 kilograms and are unwrapped. A dental handpiece is also suited.

22
Please refer to the requirements of 4.1 and 4.3 .

5．Maintenance

5.1 Regular Cassette Cleaning

It is a good habit to keep the cassette clean, which is good for

normal running of the machine. It is suggested to clean the interior
of the cassette with no-chlorine neutral detergent or liquid soap.
Scrub it using a soft pad coated with PTFE. Rinse the soap or
detergent thoroughly after scrubbing. It is more necessary to clean
the interior of the cassette if this machine is frequently used in
sterilizing instruments with lubricant. When the cassette is cleaner,
less steam will form into water beads on the flat surface of the
cassette interior and the water that touches the surface can evaporate more efficiently.
Dirt reduction in the cassette guarantees a better drying effect of the instruments. The
cassette should be cleaned after ten times` circulating procedure running.

5.2 Storage Tank Cleaning

Prevent dust from entering the storage tank. Drain the contaminated water in the tank
and rinse it with distilled water (the sole permitted choice) Don`t use chemical objects
or detergent, or the machine will be damaged.

5.3 External Cleaning

Scrub the exterior of the machine with a soft damp cloth smeared with soap. Do
not use pungent chemical detergents or disinfectants.

5.4 Air Filter Replacement

The air filter should be replaced when it has been used for six months, so that enough
clean air can be guaranteed during the air drying circulating process. Replace it with
the following steps:

1. Turn off the power switch on behind of the machine.

2. Remove the air filter and throw it away.

23
3. Install a new one。

5.5 Seal Ring Replacement

In order to ensure the normal operation of the card sterilizer, the sealing ring
should be replaced after 500 cycles or six months.

When replacing the sealing gasket of the sterilization box, flush the sealing
groove inside the sterilization box with pure water. Remove the old sealing ring, flush
the sealing groove with pure water, and then replace the new sealing ring according to
the following steps:

1. Place the sterilization box cover and new sealing ring on a clean workbench. Check
the position of the old sealing ring in the sterilization box cover. The next step is to
install the new sealing ring according to this position.
2. Remove the old sealing ring. Remove the residue in the sealing groove and flush
the sealing groove with pure water.
3. Place the circular surface of the sealing ring under the circular edge of the box
cover, and align the hole on the sealing ring with the hole on the box cover.
Note: there are 2 distinct small square projections at each corner of the
gasket.
4. Press around the sealing ring and put it into the groove to ensure that the sealing
ring is in the correct position.
Note: there may be steam leakage between the sterilization box cover and
the bottom of the box after replacing the new sealing ring. If leakage persists,
remove the gasket and check that the gasket is installed correctly.
Be careful. The metal part of the sterilization box just after the cycle is very hot.
Please do not touch it directly.

5.6 Water Quality Requirements

Only distilled water （impurity＜5ppm or conductibility＜10µS/cm）can be used

for Dmax-N Small Steam Autoclave. Inject water slowly with a funnel to avoid spill.
Pour water into the tank to 1/4 of the whole height. Please empty the waste water
bottle frequently to avoid metamorphism（this situation can be improved by adding
low concentration of dissociated chlorine disinfectant and it should be dispensed

24
according to the manufacturer`s requirements）.

5.7 Printing Paper Replacement

Replace printing paper with the following steps:：

1. Open the printer box.

2. Take out the scroll and throw away the useless

part.

3. Install new thermosensitive paper.

4. Press the Paper Running Button to let the paper come out
from the slit on the front of the printer.

5.8 Maintenance Manual

The operator and the franchiser must obey the maintenance rules to ensure
trouble-free long-term run.
Caution: Please refer to the domestic or local Safety Law and give the
operator an exam on it.
Maintenance Manual

Operating Personnel
Cassette Scrub the interior with detergent or soap lye
(Sterilizing and then rinse it thoroughly.
Box)
It is suggested to run a complete sterilizing
procedure (including the air drying process)
Machine every day after use to ensure its normal
running. It is necessary especially when the
Daily machine is left unused on the weekend or for a
long time.
Storage Tank Daily drainage
Empty the waste water bottle every time
Waste Water adding water into the storage tank. Pour some
Bottle tap water into the bottle. And dissociated
chlorine disinfectant can also be added.
Weekly Air Filter Check whether it is clean or damp. Connect
with the franchiser if it`s not clean.
Air Filter Replace it after 500 times` or 6 months`
circulating procedure running.
Semiannually
Seal Ring Replace it after 500 times` or 6 months`
circulating procedure running.
Professionals

25
 Cassette Check whether the lid, base plate and seal ring
(Sterilizing have been damaged and replace them when
Box) necessary.
Air Filter Check whether it is clean, if not, replace it.
Electromagnetic Check and clean it. Replace the piston when it
Valve becomes bad.
Pump Clean the filter of the pump and have a
replacement when necessary.
Yearly
Remove the air compressor pipe from the inlet
of the retaining valve when circulating
Retaining Valve procedures are running. Check whether there
is some steam leaked out from the valve. If so,
replace the valve.
Check whether the tank has been
Storage Tank contaminated. Rinse it with distilled water
when necessary.
Calibration Calibrate this machine.

6．Common Failures and Solving Methods

Failures Solving Methods
Check whether the attaching plug has been correctly
plugged into the socket with earth wire protection and
whether the power cord has been connected to the back of
The machine can the machine.
not start. Try another electric circuit. Turn off the power switch and
turn it on after 10 seconds.
Check the power circuit breaker and the fuse.
Water leakage at Check whether any water has spilled over when being
the bottom of the injected into the tank.
machine Make sure the plug of the drain pipe has tightly blocked the
pipe. Take out the cassette and make it in again. Then retry
the sterilizing procedure.
Be careful about the cassette just taken out. Steam still
exists inside and the metal portion is burning hot.
If water drops from the bottom of the machine when a
procedure is running, check whether the seal ring of the
cassette has been correctly installed and whether it is
broken. Replace the seal ring if necessary.
Be careful about the cassette just taken out. Steam still
exists inside and the metal portion is burning hot.
Retry the circulating procedure. If leakage still exists, run
the procedure once more with a third cassette.
If leakage still can’t be solved, turn off the power switch,
take out the cassette, and unplug the power cord. Then
connect with the franchiser.

26
 The circulating Write down the “Warning” code. Restart the sterilizing
procedure breaks procedure. If the problem still exists, take out the sterilizing
off and the screen box (cassette).
displays Be careful about the cassette just taken out. Steam still
“Warning”. exists inside and the metal portion is burning hot.
Check whether the two holes on behind of the seal ring has
been directed well at the holes of the cassette lid and
whether the elastic edge of the seal ring is totally free.
Check whether the drain pipe has been twisted or blocked.
If it has been twisted, try to straighten it. But if you fail in
your attempt to straighten it, remove the drain pipe from the
push style pipe interface on the back of the machine and cut
down the damaged part with scissors. Make sure the
remaining pipe is long enough to connect to the machine. If
it becomes too short, please connect with the franchiser to
have a replacement.
Check whether the machine is affected by occasional
electrical interference.
Retry the circulating procedure. If the problem still exists,
write down the failure code and connect with the
franchiser.
Remove the sterilizing box and make it in again. Retry the
circulating procedure.
If the problem still exists, check whether the seal ring has
Plenty of steam been correctly installed and whether it has got damaged.
leaks out from the Replace the seal ring when necessary. Be careful about the
front of the cassette just taken out. Steam still exists inside and the
machine. metal portion is burning hot.
If leakage still exists, turn off the machine, take out the
cassette and connect with the franchiser. 。

The machine can That means the water you use is not distilled water or the
not start and the distilled water you use is not qualified.
screen displays Drain the tank. Inject distilled water (impurity＜5ppm or
“Unqualified conductivity＜10µS/cm) into it. Test the water quality in
Water”. advance if you have a water conductivity testing meter.
The machine can
not start and the That means the water level of the tank is too low. Add
screen displays some water, please.
“Tank Water
Shortage”
Make sure the cable of the printer has firmly connected
The printer don't with the printer and the joint on the back of the machine.
work. Make sure the power switch is on. Turn off the power
switch and turn it on after 10 seconds.

Make sure the paper has been correctly installed and it has
The printer works not been used up. Check whether the thermal side of the
but can't print. paper can touch the thermal printing head.

27
 The system time is
not correct or That`s because the time and date haven`t been set.
accurate.

7．Quality Assurance

Warranty

We promise a one-year warranty on the new Dmax-N 5L Small Steam Autoclave

from our company. When failures come, we provide free technical support and
on-site maintenance on the machine under warranty. After the warranty, we will
provide quality paid services at cost price. If the failure is caused by the user`s own
fault or accident, our company will not bear the responsibility.

8．Technical Specifications
Body Measurements: 60X48X21cm（L*W*H）
Cavity Measurements of the Cassette: 28X18X3.8cm（L*W*H）
Sterilizing Cavity Volume: 5L
Storage Tank Volume: 5L
Weight (Distilled Water Not Included): 45 Kg
Maximum Steam Temperature: 138℃
Maximum Operating Pressure: 250 kPa
Power Supply Range（±10%） 220-240V ,50HZ, 1300W
Level of Protection: 1
Using Environment: Indoor
28
Temperature & Humidity of the Using Environment: 15℃-25℃， 25%-70%
Using Height (Elevation): 2000m at most

Printer Type: Thermal Printer

Print Span: 40 characters /line
Speed: 1line/second
Scroll Capacity: 50 times` circulating procedures per scroll

9 Parts List

Serial No. Component Name Quantity Remarks Inspection

1 Main Body 1
Sterilizing Box
2 (Cassette) 1Set
Components
3 Rubber Gasket 1
4 Disinfection Grid 1
Not
5 Drying Board 5 included in
2L unit
6 Waste Water Tank 1
/Bottle
7 Exhaust Pipe 1.5m

8 Operation & 2
Maintenance Manual
9 Packing List 1

10 Conformity 1
Certificate
F8AL250V(
Main
11 Fuse 2 board)
F10AL250
V

29
 （Machine
）

12 Receipt of installation 1
and acceptance
13 Simple operation 1
manual

30
10. Electromagnetic Compatibility
1. Basic performance of product: Normal operation of sterilizer;
2. All cables:
No. Name Cable length (m) shield or not Remark
1 POWER LINE 1.8M NO
3. Product size (L × W × H): See page 21 in this manual
Note:
1. The purchaser or user of the AuToClave should use this device in the
electromagnetic environment specified in Table 201, 202, 203, 204, the
abnormal operation otherwise might be caused.
2. The portable and movable RF communication equipment would affect the
normal operation of the AuToClave, please use it under recommended
electromagnetic environment.
Caution:
1. Except to the accessories and cables provided by the manufacturer of the
AuToClave, using other accessories and cables may result in emission increase or
interference immunity reduction of this device.
2. AuToClave should not be close to or stacked with other equipment in
operation. You should observe and verify the device can be operated normally in
its current configuration if it has to do like that.
Table 201
Guideline and declaration-Electromagnetic Emission
It is expected that the AuToClave should be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in such
environment:
Emission test Compliance Electromagnetic Environment - Guideline
The AuToClave uses radio frequency energy for its
Radio frequency
internal functions only. Therefore, its RF emission is
emission Group 1
very low, and it is rarely possible to interfere with
GB 4824
surrounding electronic equipment.
Radio frequency
The AuToClave is applicable for all non-domestic and
emission GB Class A
domestic facilities that are not directly connected to the
4824
common low-voltage supply grid.
harmonic
Not
emission
Applicable
GB 17625.1
Voltage
fluctuation /
Not
flashing
Applicable
emission
GB 17625.2

Table 202
31
 Guide and declaration-EMI
It is expected that the AuToClave should be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in such environment:
IEC 60601
Compliance
Immunity immunity test Guideline of electromagnetic environment
level
test level
Electrostatic ±6kV contact ±6kV contact The ground should be the wood, concrete
discharge discharge discharge or tiles. The relative humidity should be
GB/T ±8kV air ±8kV air 30% at least if the ground is covered by
17626.2 discharge discharge synthetic materials.
Electrical
±2kV for
fast
power line ±2kV for The quality of network power supply
transient
± 1kV for power line should meet the requirement of typical
burst
input / output Not Applicable commercial or hospital environment.
GB/T
lines
17626.4
± 1kV line ± 1kV line to
Surge The quality of network power supply
to line line
GB/T should meet the requirement of typical
± 2kV line to ± 2kV line to
17626.5 commercial or hospital environment.
ground ground
<5% UT for
<5% UT for 0.5
0.5 cycle (>
Voltage sag, cycle (> 95%
95% sag at
short sag at UT,) ,
UT,) , 40% UT The quality of network power supply
interruption 40% UT for 5
for 5 cycles should meet the requirement of typical
and voltage cycles (60%
(60% sag at commercial or hospital environment. If the
change of sag at UT)
UT) user of AuToClave needs to run the device
input power 70% UT for 25
70% UT for 25 continuously during power interruption, it
line cycles (30%
cycles (30% is recommended that the device should be
GB/T sag at UT) ,
sag at UT) , powered by UPS or batteries.
17626.11 <5% UT for 5s
<5% UT for
(> 95% drop at
5s (> 95%
UT)
drop at UT)
Power
frequency The power frequency magnetic field
magnetic should have the typical features required
3 A/m 3 A/m
field (50 Hz by the representative commercial or
/ 60 Hz) hospital environment.
GB/T
Note: UT refers to the AC voltage before applying the test voltage.

32
 Table 203

Guideline and declaration-EMI

It is expected that the AuToClave should be used in the electromagnetic environment
specified below, and the purchaser or user should ensure that it is used in such environment:
IEC 60601
Immunity Compliance
immunity Electromagnetic environment-Guideline
test level
test level
When using, the portable and mobile RF
communication equipment should not be more
closely to any part of the sterilizer than the
recommended isolation distances, including
cables. The distance should be calculated by the
formula corresponding to the transmitter
frequency.
Recommended isolation distance:
Radio 3V 3V (effective Where:
d  1 .2 P d  1 .2 P 80MHz～800MHz
frequency (effective value)
d  2 .3 P 800MHz～2.5GHz
conduction value) P- Max rated output power provided by
the transmitter manufacturer, in watts (W);
GB/T 150kHz～
d - Recommended isolation distance, in
17626.6 80MHz meters (m).
3 V/m The field strength of the fixed RF
transmitter is determined by investigated
Radio 80MHz～ 3V/m through the electromagnetic field a. The field
frequency 2.5GHz strength should be lower than compliance level
in each frequency scope b.
radiation
The Interference may occur near the
GB/T
17626.3 device marked the following symbols.

Note 1: The formula for higher frequency section should be used at the frequency point
80MHz and 800MHz.
Note 2: These guidelines may not be suitable for all situations and the electromagnetic
transmission is affected by the absorption and reflection of buildings, objects and human
bodies.
a
Fixed transmitter, such as wireless (cellular / cordless) telephones and mobile ground
radio base stations, amateur radio, AM and FM radio and television broadcasts, its field
strength in theory cannot be accurately predicted. In order to evaluate the
electromagnetic environment of fixed RF transmitters, the investigation of
electromagnetic sites should be considered. If the field strength of the place where the
sterilizer is located is higher than applicable RF compliance level above mentioned, the
AuToClave should be observed to verify its normal operation. If abnormal performance
is found, it is necessary to adopt some additional measures, such as adjusting the
direction or position of the sterilizer.
b The field strength should be less than 3V/m from 150kHz to 80MHz.

33
 Table 204

The recommended distance between portable and movable RF communication equipment

and AuToClave
It is expected that the AuToClave should be used in electromagnetic environment in which
the radio frequency interference is under control. Depending on the maximum rated output
power of the communication equipment, the purchaser or user can prevent the
electromagnetic interference by maintaining the minimum distance recommended below
between the portable and mobile radio frequency communication equipment (transmitter)
and the sterilizer.
Isolation distance corresponding to the different frequencies of the transmitter
Max rated
(m)
output
power of 150kHz～ 150kHz～ 150kHz～80MHz
transmitter 80MHz 80MHz d  2 .3 P
(W);
d  1 .2 P d  1 .2 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For the maximum rated output power of the transmitter not listed in the table above, it is
recommended to determine the isolation distance d in meters (m) using the formula in the
corresponding column of transmitter frequency, where P is the max rated output power of
transmitter provided by the manufacturer, in watts (W).
Note 1: The formula for higher frequency section should be used at the frequency point
80MHz and 800MHz.
Note 2: These guidelines may not be suitable for all situations and the electromagnetic
transmission is affected by the absorption and reflection of buildings, objects and human
bodies.

34
 Appendix
Corresponding relation between pressure and time during sterilization cycle：

Work stage Displacement Pressurizing Sterilizing Exhausting Drying

≥205 220→
P ≤10kpa P 10→220kpa P P P ≤20kpa
kpa 10kpa
instruments
T ≤300s T ≤8min T 4min T ≤2min T 60min

≤10 ≥205 220→

P P 10→220kpa P P P ≤20kpa
Wrapped kpa kpa 10kpa
instruments
T ≤300s T ≤8min T 10min T ≤2min T 60min

≥105 120→
Non-metallic P ≤10kpa P 10→110kpa P P P ≤20kpa
kpa 10kpa
Instruments
T ≤300s T ≤16min T 20min T ≤2min T 60min

≥205 220→
Large-sized P ≤10kpa P 10→220kpa P P P ≤20kpa
kpa 10kpa
Instruments
T ≤300s T ≤8min T 8min T ≤2min T 60min

Schematic diagram of the relation between pressure and time

35