ENBIO Enbio S User manual

ver. 21.01.2022
User manual

2 3
1. Introduction ........................................................................................... 33
1.1 Purpose....................................................................................................................................... 33
1.2 Purpose of the device........................................................................................................ 33
1.3 Symbols used on the device......................................................................................... 33
1.4 Precautions, requirements and recommendations......................................... 34
2. Scope of delivery and unpacking of the device .............................. 35
2.1 Unpacking of the device.................................................................................................. 35
2.2 Standard equipment.......................................................................................................... 35
3. Device installation................................................................................. 35
3.1 Water quality............................................................................................................................ 36
4. Tool preparation and loading ............................................................. 37
4.1 Tool pack preparation........................................................................................................ 37
4.1.1 Characteristics of a sterilization pack.................................................................... 37
4.1.2 Rules for arranging tools on a tray ......................................................................... 37
4.1.3 Principles of packing tools for sterilization.........................................................38
5. Starting the device................................................................................ 38
5.1 Initial Start-Up......................................................................................................................... 38
5.2 Program selection................................................................................................................ 38
5.3 Test programs.......................................................................................................................... 41
5.4 Information menu................................................................................................................ 44
5.4.1 Counters................................................................................................................................. 45
5.5 Restarting .................................................................................................................................. 45
6. Maintenance and care.......................................................................... 47
6.1 Replacement parts............................................................................................................... 48
6.2 Periodic inspections............................................................................................................ 48
7. Data archiving........................................................................................ 49
8. ENBIODATAVIEWER software .............................................................. 49
8.1 Software installation........................................................................................................... 50
8.2 Program construction and main functionalities............................................... 52
9. Warning messages and error codes................................................... 55
9.1 Warning messages............................................................................................................... 55
9.2 Information Codes.................................................................................................................55
9.3 Error codes................................................................................................................................ 56
10. Warranty claim handling ................................................................... 57
11. Warranty terms and conditions........................................................ 58
12. Technical information......................................................................... 58
EN
Table of Contents
FRONT VIEW
162
561
LOCKING KNOB
FRONT
DISPLAY
252
GENERAL VIEW
e latest version of the manual is available at
www.enbio.com

4 5
registered with the General Inspectorate of
Environmental Protection; this unit handles
selective waste collection.
1.4 Precautions, requirements and recommendations
- Enbio S complies with IEC 60601-1-2:2014 (Edition 4.0)
- Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally. Max power cord length is 160 cm.
- Use of accessories and cables other than those specied or provided by Enbio co-
uld result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
- Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the Enbio S, including cables specied by Enbio. Otherwise, degra-
dation of the performance of this equipment could result.
- The EMISSIONS characteristics of this equipment make it suitable for use in in-
dustrial areas and hospitals (CISPR 11 class A). If it is used in a residential environ-
ment (for which CISPR 11 class B is normally required) this equipment might not
oer adequate protection to radio-frequency communication services. The user
might need to take mitigation measures, such as relocating or re-orienting the
equipment.
– The user is responsible for the installation, correct operation and maintenance of
the device in accordance with instructions provided in this user manual. If need-
ed, contact the service or the supplier of the device.
– The sterilizer is not intended for sterilizing liquids, biomedical waste or pharma-
ceutical products.
– The sterilizer must not be used if explosive gases or vapours are present in the air.
– After the cycle is completed, the load is hot. Remove tools or packs from the
chamber using appropriate thermal gloves or equipment that prevents burns.
– Do not remove the rating plate or any other elements of labelling from the de-
vice.
– Follow guidelines for preparing tools for sterilization.
– Pouring water or other liquids on the device may cause a short-circuit.
– Prior to inspection, maintenance or servicing, turn o the device and disconnect
it from the power source.
– Servicing may only be performed by trained service personnel and using original
replacement parts.
– The device is intended for indoor use only.
– Max working high elevation of the device is 2,000 m above sea level.
– Pollution Degree 2: Normally only nonconductive pollution occurs. Temporary
conductivity caused by condensation is to be expected.
– Overvoltage Category II.
–
If the equipment is used in a manner not specied by the manufacturer, the
protection provided by the equipment may be impaired.
– Use only detachable cord that rated equal or greater to the equipment electrical
ratings.
Read this Operating Manual carefully before using this device. Install and
operate the device strictly as specied herein. Comply with all safety re-
quirements for the device.This will ensure proper and safe operation of this
device. Any other application, inconsistent with this manual, may lead to
dangerous accidents. Restrict unauthorised personnel access to the device
and train the personnel handling the device. An operator of this device is
any person who, by training, experience and knowledge of applicable ref-
erence standards, manuals and occupational health and safety regulations
has been authorised for the essential operation with the device and who
is capable of identifying and avoiding the hazards related to operation of
this product.
Always append this Operating Manual with the device if transferred to a
new owner. The Operating Manual contains detailed information about
assembly, installation, initial start-up, use, repairs and maintenance of the
device. If the device is used as intended, this Manual will provide sucient
guidance to qualied personnel. Keep this Operating Manual close to the
device and easily accessible at all times. As required by continuous im-
provement of the product, the manufacturer has the right to amend this
1. INTRODUCTION
1.1 Purpose
The purpose of this user manual is to provide information about the ENBIO sterilizer and
ensure:
• proper installation and setup,
• optimum use,
• safe and reliable operation,
• regular and correct maintenance and servicing in accordance with requirements.
The sterilizers conrmed to UL 61010-1:2012 Ed.3+R:19Jul2019, CAN/CSA C22.2 NO.
61010-1-12 (R2017), UL 61010-2-040:2016 Ed.2, CSA C22.2#61010-2-040:2016 Ed.2
1.2 Indications for Use.
The Enbio S is an air-removal (pre-vacuum) table-top steam sterilizer intended for use by
a health care provider to sterilize medical products by means of pressurized steam. It is
suitable for the sterilization of dental and medical instruments that are validated to be
sterilized by steam. The Enbio S has not been designed to sterilize liquid loads, bio-medical
waste or materials not compatible with steam sterilization. The processing of such loads
may result in incomplete sterilization and/or damage to the autoclave.
Please refer to the table below for program name, load description, sterilization tempera-
ture, exposure time, drying time and maximum load.
PRO-
GRAM
NAME
LOAD DESCRIPTION STER-
ILIZA-
TION
TEM-
PERA-
TURE
STER-
ILIZA-
TION
TIME
DRY-
ING
TIME
MAX-
IMUM
LOAD
MAX-
IMUM
LOAD
134˚C solid objects, small porous objects, simple
objects recessed, narrow-clearance items,
dental handpieces, and textiles;
wrapped and unwrapped
134˚C
(273˚F)
4 min-
utes
3 min-
utes
0.5 Kg
/1.1 lbs
121°C solid objects, small porous objects, simple
objects recessed, narrow-clearance items,
dental handpieces, textiles, and plastics;
wrapped and unwrapped
121°C
(250˚F)
30
min-
utes
5 min-
utes
0.5 Kg
/1.1 lbs
The sterilizer is suitable for use in the vicinity of other powered medical
products.
The ENBIO device may not be used to sterilize liquids, biomedical
waste or pharmaceutical products.
The device is intended for professional use by properly trained sta only.
1.3 Symbols used on the device
This symbol is located on the front of the device, on the
upper part of the drawer front. It is recommended to
maintain caution due to high temperature within and
around the operating chamber.
This symbol is located on the device’s rating plate and
indicates the serial number.
This symbol is located on the device’s rating plate and
indicates compliance with EC guidelines.
This symbol is located on the device’s rating plate and
indicates the device’s date of production.
This symbol is located on the device’s rating plate and
indicates the device’s manufacturer.
This symbol is located in the user manual and indi-
cates reading the information provided in the user
manual.
DIRECTIVE 2012/19/EU OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 4
July 2012 on waste electrical and electronic
equipment (WEEE) , collection point
solid objects, non-porous objects,
simple instruments (such as scis-
sors, handles, pliers, chisels,
probes, etc.), and dental handpieces;
unwrapped
* - Immediate Use Steam Sterilization
cycle
134°C
FAST*
134˚C
(273˚F)
4 min-
utes
N/A 0.5 Kg
/1.1 lbs

6 7
can be removed directly to the sewerage or to a special container intended
for wastewater. If using container, place the tube end inside the container
and secure the inlet with the plug provided. The tube must not be sub-
merged in the wastewater.
f. The wastewater container or the sewege drain must be located below the
device.
g. If using wastewater containers, we recommend using containers of the
same volume as those used for the deionised water. Emptying them con-
currently with replacing/lling the deionised water containers will prevent
overow.
Correct positioning of tubes in the water supply and wastewater
containers.
h. Leave 5 cm (2 in) of space behind the device and 1 cm (0.4 in) on each
side from walls or other elements in order to ensure sucient ventilation.
i. The device should be positioned in a way that ensures easy access to
the main switch located on the rear panel of the
device.
j. Do not position the device near to washbasins
or other places where it could be poured with
water - possible short-circuit.
k. Install the device in a well-ventilated room, away
from heat sources and rooms where mixtures of
gases or liquids, and other hazardous agents may
form.
l. Ensure the following environment conditions: op-
erating temperature range +5°C to +40°C (+41°F
to +104°F) / relative humidity 0–90%, storage tem-
perature range from -20°C to +60°C (-4°F to 140°F) /
relative humidity 0–90%.
Enbio S device is designed for self-assembly by the end user and do
not require any special installation at the place of use. The user is re-
sponsible for the correct installation of the device on spot, according
to this manual.
3.1 Water quality
ENBIO S sterilizers use demineralized or distilled water to form steam dur-
ing the sterilization process. The total mineral content in the water used
for sterilization must be lower than 10 ppm, or for conductance measure-
ments, lower than 15 μS/cm.
Standard tap water has hardness within the 2–3 mmol/l range and must
not exceed 5 mmol/l according to current regulations, making it unsuitable
for use in ENBIO S sterilizers. Therefore tap water cannot be used as feed
water for ENBIO S sterilizers.
The table below presents the hardness and conductance parameters of
water used in steam sterilization according to EN 13060.
Acceptable parameters of water used for sterilization
Hardness < 0.02 mmol/l
Conductance(at 20oC)/(at 68°F) < 15 μS/cm
Chemical additives No chemical agents or additives must be added
to the water used in the sterilization process,
even if they are intended specically for use
in steam generators, or for use as additives in
sterilization, disinfection, cleaning or corrosion
protection.
Water conductance above 50 μS/cm may have a major impact on
the sterilization process and cause serious damage to the sterilizer, and
constitute ground for voiding the warranty. Use of water with impuri-
ties level exceeding the levels specied in the EN 13060 standard in the
steam generator can signicantly shorten the sterilizer’s lifetime.
The distilled water in the supply tank should be replaced at least
once every three months due to the increasing conductivity due to pro-
Manual or make changes to the device without prior notice. Enbio
Group AG shall not be liable for damage incurred during the wait for war-
ranty service, any damage to the Customer’s property other than this de-
vice, or errors caused by improper installation and/or improper operation
of the device.
Detailed recommendations, coutnerindications and warnings are
described in the relevant sections.
2. SCOPE OF DELIVERY AND UNPACKING OF THE
DEVICE.
2.1 Unpacking of the device
If the sterilizer was transported or stored at a temperature or hu-
midity dierent than that at the location of installation, wait for 60
min. When moved from a cold room to a warm one, the device may
contain moisture that, by negatively aecting the device’s electrical
components, may cause damage to it after startup.
Remove the device from its packaging carefully.
Attention! Check the packaging and its contents for external dama-
ge. If damage is found, contact the seller or the transport enterprise
to prepare a damage report.
It is recommended to leave the carton for possible autoclave transport.
2.2 Standard equipment
Verify the contents of the packaging in which the device has been deliv-
ered prior to installing it. The delivery packaging should contain:
1. ENBIO S sterilizer
2. Water and condensate connection cables,
rubber plugs for water/condensate containers
3. USB drive
4. Operating Manual (PDF, on USB drive)
5. HEPA lter
6. Validation report
7. FDA Approval
Accoprding to Directive 2012/19/EU of the European Parliament and of
the Council of July 4th, 2012 on waste electrical and electronic equip-
ment (WEEE) must not be disposed of or stored with household waste.
Take the waste device to the nearest WEEE collection point registered
with the General Inspectorate of Environmental Protection; this unit
handles selective waste collection.
3. DEVICE INSTALLATION
We recommend reading this user manual carefully before using the
ENBIO S device. Follow all applicable safety guidelines and ROHS
regulations when operating the device.
Mounting the HEPA lter. For reasons of transport safety, the HEPA
lter has not been installed in the device. Remove it from the bag
placed in the carton and tighten it yourself in a specially designated
place on the back of the device. The lter should be screwed in
manually until resistance is felt.
a. The device should be positioned on a at, even surface. Do not use the
device if it is inclined.
b. The device should be connected to a power supply that is grounded,
equipped with fuses and has the same voltage rating as that indicated
on the device.
c. Demineralized or distilled water can be used in the device. Under no
circumstances should tap water be used.
d . Connect the connection tube included with the device to the water supply
quick-release coupling on the device’s rear panel, marked as WATER IN. Submerge
the other end of the tube in the water supply container. The device is equipped
with a water suction pump, there is no need to position the water container above
or on the same level as the device. In order to secure the water supply tube, use
the plug included in the delivery and place the plug in the opening of the water
supply container.
e. The wastewater formed after the water is turned into steam during the steriliza-
tion process can be removed using the tube provided, which should be connected
to the port at the device’s rear panel, marked as WATER OUT. The wastewater
WATER INLET
HEPA
CONDENSATE
fragile
www.enbio.com

8 9
longed contact with air. If the tank was contaminated, it should also be
changed to a new one. The tank should be closed with the attached cap.
Then the water does not change its properties so quickly.
The manufacturer’s warranty expires when the autoclave has been
used with water services of a quality not compliant with the recom-
mended one
4. TOOL PREPARATION AND LOADING
Only clean and dry tools may be sterilized. For this reason, before
loading tools on the tray, clean and disinfect the tools in accordance
with current regulations. Residue of agents used or solid particles may
prevent the ster-ilization process from completing successfully.
Furthermore, sterilization of tools not subjected earlier to pre-cleaning
may cause damage to both the tools and the sterilizer.
If the tools were covered in grease, remove its excess.
Optimum method of positioning tools to be sterilized on the tray:
• For non-packaged tools – place the tools on the tray in such a manner
so they do not contact each other directly. This will accelerate the drying
process.
•
For packed tools – position them on the tray in disposable sleeves as
recommended by the pack manufacturer. Position packages with either
the paper or lm sides facing each other. Otherwise the packages may
cement with each other during the sterilization.
4.1. Tool pack preparation
4.1.1 Characteristics of a sterilization pack
It is recommended to use sterilization packages that meet the require-
ments of the standards EN ISO 11607-1:2019, EN 868-2-10:2017-3.
A suitable pack is characterised by:
– good permeation of the sterilization agent to the inside of the pack –
resistance to damage during the sterilization process,
– ensuring tight, durable sealing of the contents and their safe removal
for further use,
– forming a barrier for microorganisms and undesired substances such as
adhesive, ink from the label or a chemical test.
4.1.2 Rules for arranging tools on a tray
Sterilized instruments should not protrude beyond the outline of the
sterilization tray, special attention should be paid to sterilized instruments
without packages. The tools must be positioned in such a way that no part
of them falls into the holes of the tray, and does not rest on the edge of the
sterilization tray or protrudes above the tray outline.
Failure to comply with the above recommendations may damage the ster-
ilization chamber phase, which will cause a chamber leak.
• Sterilized instruments in packages: Arrange in a tray so that the package
does not come into contact with the door seal and the phase of the steri-
lization chamber. Failure to comply may result in a lack of tightness in the
device.
• Do not exceed a maximum weight of 500 g (1.10 lb) for ENBIO S.
• Special attention should be paid so that the ends of the packs do not
protrude out of the sterilizer tray, which may cause the pack to jam during
closing and lead to leakage of the sterilizer working chamber
• It is recommended that when the working chamber is signicantly load-
ed, the first packages should be directed with the foil side to the bottom
of the tray. This guarantees faster and more efficient drying of packets.
• Do not use packages or wrapping in the 134˚C FAST pro-
gram.
• Items sterilized using 134˚C FAST program are intended for
immediate use only and cannot be stored or held for future
use.
Not following the manufacturer’s instructions will be associated with the
loss of warranty on the device.
4.1.3 Principles of packing tools for sterilization
Sterilization pack
type Principles of packing tools
Disposable paper
and lm packages
• Bags should be lled only to 3/4 volume to allow
proper sealing and minimize the risk of breakage
• a distance of 30 mm (1.2 in) should be kept between
the welding and sterilized equipment
• Protect sharp edges to avoid damage to the
packaging
• the packaging material must not be laid loosely or
stretched so that it does not aect pressure changes
during sterilization
• the equipment should be stacked so that the paper
side contacts the paper side as the sterilizing agent
penetrates and air exchange can only take place
through paper
• a label should be placed on the packaging with
information about the content of the packaging, the
code of the packer, date of sterilization and expiry date
and sterilization parameters
• it is recommended to insert a sterilization strip into
each process that discolours as a result of the correct
sterilization cycle
Sample placing of sterilization packages. Example of solid load.
5. STARTING THE DEVICE
5.1 Initial Start-Up
Before initiating the sterilization cycle, turn the device on using the main
switch located on the rear panel of the device. Make sure that water supply
and wastewater tubes are connected correctly, and that water is present in
the water supply container, while the wastewater tank is empty, in order to
prevent overow. Monitor the water level in the tank regularly, depending
on how frequently you perform your processes.
Place tools or materials in the working chamber tray and close the chamber
and turn the knob locking the front of the device clockwise.
5.2 Program selection
Depending on the type of load to be sterilized, the user is responsible for
selecting the appropriate program dedicated for the given type of
load, in accordance with the manufacturer’s recommendations for
sterilization.
After the process in 134C FAST program, tools are wet and hot.
MAIN SWITCH
During 134 C FAST program do not use packages or wrapping.

10 11
PROGRAM
ENBIO S 134oC 121oC
Type of load
Wrapped or
Unwrapped
instruments
Wrapped or
Unwrapped
instruments
Process tem-
perature 134°C 121°C
Pre-vacuum
number 3 3
Sterilization
duration 4 min 30 min
Drying
duration
3 min 5 min
Total
process
duration*
100g: 13 min 100g: 45 min
Class B B
*Ambient temperature can aect the process extension.
*The duration of the rst process may be longer due to the need for the device to heat up.
The 134oC program is recommended for the majority of sterilized
materials due to the short duration of the entire program. The
121oC should be used to sterilize all other materials that cannot be
subjected to sterilization at the temperature of 134oC. Do not ex-
ceed a maximum weight of 500 g (1.10 lb) for ENBIO S.
From here you can execute the Program, go to the Test, Information menu,
and the COUNTERS menu.
In the Program menu, you can choose the 121°C, 134°C temperature pro-
grams. When the chamber is opened, the symbol blinks.
When the chamber is locked by turning the lock knob clockwise, the display
will show the symbol, indicating the chamber has been
closed correctly.
Now you can select the program by
pressing the symbol of the tempera-
ture you want to perform the
sterilization for example in or
The selected program is initiated by
pressing the corresponding symbol
.
If the USB drive has not been inserted
in the device, the USB symbol is not
displayed in the bottom right corner
of the screen, and a message about
the missing USB drive is displayed.
The program data will not be saved.
You can continue working without saving the data on the USB drive by
pressing the eld or stop working by selecting the , eld
to insert the drive in the port and start the program from the beginning.
If you decide to continue working or the . eld has been
selected, the screen will display a chart of pressure during the entire pro-
cess, with the current stage of the program indicated, while information
on subsequent stages is displayed in the upper left corner of the screen.
When a program is being run, the screen displays the temperature of the
selected sterilization program or , the current temper-
ature of the process chamber in the
bottom left corner , the
pressure currently in the chamber in
the bottom right corner
while the process duration left is
displayed in the upper right corner
of the screen . This is
the expected time, which may be extended due to the mass and type of
charge.
During the process, the eld is displayed instead of the START
eld, enabling you to stop the process at any time.
The upper left corner of the screen displays the status of individual subse-
quent program stages, e.g. – Chamber lock
– Process chamber heating
If the process was completed suc-
cessfully, the display will alternately
show information that the process
has been completed and the load is
sterile, and that the chamber may
be opened.
By pressing the eld,
you return to the start screen.
ATTENTION! When the process is completed, the chamber, the tray
and the load are hot. Maintain particular care and use protective
gloves to remove the load, or wait until it cools.
Performing the sterilization process in the ENBIO S device does not af-
fect material biocompatibility. All components of the device that are in
direct contact with the sterilized load have no toxic, sensitising or irri-
tating eects.
134oC FAST
134°C
1
4min
-
100g: 7min
S
Unwrapped
instruments
only

12 13
5.3 Test programs
By pressing the eld, you can go to the test program menu.
From here you can select the vacuum
leak test program and the Helix/B&D
test program. Select the appropriate
program by pressing the relevant
eld on the display.
When the process chamber is closed,
the information
changes to and by
pressing this eld you launch the selected test program.
If the USB drive has not been inserted in the device, the USB symbol is not
displayed in the bottom right corner of the screen, and a message about
the missing USB drive is displayed.
The test program data will not be saved. You can continue working without
saving the data on the USB drive by pressing the eld or stop work-
ing by selecting the eld to
insert the drive in the
port and start the test program from
the beginning.
Program ENBIO S Bowie & Dick
/ Helix Vacuum leak test
Process temperature 134°C –
Pre-vacuum number 3 1
Sterilization duration 3.5 min –
Drying duration 3 min –
Total process duration 15 min 16 min
Vacuum leak test
The vacuum leak test may only be performed on a cold device, before work
is commenced. The vacuum leak test enables testing the autoclave for the
presence of leaks. The following are checked during the test:
• Vacuum pump performance.
• Pneumatic system sealing.
When the vacuum leak test program is selected and launched with the
button, the vacuum leak test progress screen is displayed.
Information on pressure loss in the process chamber, and the test duration
are displayed.
When the test program is complet-
ed, the following screens are dis-
played alternately.
When the test program was complet-
ed successfully.
When the test program was not com-
pleted successfully.
After pressing the
eld, the start screen is displayed.
The process chamber must be completely dry and cold during the
vacuum leak test. Otherwise, the vacuum leak test results may not be
fully reliable, even if the sterilizer is fully functional. When the test is
completed, a message with the results will be displayed. If the result
is negative, check, clean or replace the seal, clean the front edge of
the chamber and repeat the test.
If the device fails the test again, contact your supplier or the man-
ufacturer.
Bowie&Dick test
Perform the Bowie&Dick test daily before commencing work, in order to
verify that the device performs sterilization correctly.
The Bowie&Dick test, also known as the steam penetration test, imitates a
small, highly porous load.
It contains sheets of paper packaged in a small pack containing a chemical
indicator (a physicochemical test).
This test assesses the device’s performance in sterilizing charges composed
of porous objects:
• Pre-vacuum performance and steam penetration.
• Saturated steam temperature and pressure, reached for a specic time.
How to perform the test:
• Perform the test with an empty chamber, as per the EN 13060 standard.
• Place the Bowie-Dick test pack in the chamber, in the middle of the tray.
When the Helix/B&D test program is selected and launched with the
button, the program progress screen is displayed.
Process parameter information is
displayed.
The Helix/B&D test program can be
stopped at any time by pressing the
eld.

14 15
When the test program is completed,
the following screens are displayed
alternately.
You can safely open the sterilizer’s
process chamber.
When the process chamber is
opened, the start screen is displayed.
- Remove the test pack.
WARNING! The package will be hot.
In order to interpret the test correctly, read the instruction provided by the
test pack manufacturer.
- Open the pack and remove the chemical indicator from inside.
POSITIVE RESULT
chemical indicator has changed color on a dark uniform
over the entire surface.
NEGATIVE RESULT
The middle of the test eld remains clear because of the
residual air in the middle of the device under test.
Any change of color, uneven coloring of the test, indicates the presence of
air during the test cycle, caused by faulty operation of the sterilizer.
5.4 Information menu
The information menu can be ac-
cessed by pressing the eld.
Here, information about the device
type, serial number, number of per-
formed processes, amount of free
memory available on the USB drive
for saving process data, and the
service menu with the
process counters for sealing, lter
and the next service inspection can
be displayed.
You can also change the date and
time.
In order to set the date or time,
touch the digits on the display.
When a eld is selected, it starts
to blink and arrows
used to change values are dis-
played, up and down .
This way you can correctly set the
date and time.
Pressing the number again con-
rms it, and you can change anoth-
er parameter.
We can choose the language in
the same way by clicking on the
shortcut.
5.4.1 Counters
The ENBIO S sterilizer counts the number of performed processes and uses
it to notify you about the recommended dates of replacing elements sub-
ject to wearing down, and about required service inspections.
No. Name Recommended
frequency of
replacement
(cycles)
Yellow (Ap-
proaching the
replacement
date, number
of cycles)
Red (Exceeded
replacement
date, number of
cycles)
1. HEPA lter after 1000 from 980 after 1000
By pressing the eld, you go to the counter display.
The number of performed processes is on the left hand side,
and on the right hand side – the number at which the given el-
ement should be replaced or a service inspection performed
. After replacing a lter
or seal, the values can be reset by
the user by pressing the
button. The service inspection value
can only be reset by an authorised
service.
When approaching a value when re-
placement of an element or a service
inspection is recommended, the val-
ues will be highlighted in yellow.
If the limits are exceeded, the value
will be displayed in red.
During regular operation, info screens concerning replacement of individu-
al elements or required service inspection are displayed alternately.
Counter values displayed in yellow or red do not prevent the device from
operation. However, exceeding the required inspection date may signi-
cantly aect the device’s operation and the load sterilization process.
For replacing individual elements, please contact the manufacturer or
supplier.
5.5. Restarting
Restarting the device is forced when a process is aborted by the user by
pressing the eld, or when power or water supply is lost.

16 17
If the eld is selected, the following messages will be alter-
nately displayed, notifying you that the process has been aborted by the
user and pressure is being equalised
in the process chamber, and a mes-
sage notifying you that the process
has not been completed correctly
and the load is not sterile.
When the pressure is equalised in the
process chamber, the following mes-
sages will be displayed alternately on
the screen. You can freely open the
device now.
The following screen will be dis-
played when the chamber is opened.
By selecting the
eld, you can return to the start
screen.
However, in order to do so, you must enter the 4-digit security code 0000.
If the code is entered incorrectly, a
message will be displayed on the
screen.
Enter the code again. The arrow en-
ables cancelling incorrectly entered
digits.
When the code is entered correctly, the start screen will be displayed.
6. MAINTENANCE AND CARE
Tray cleaning
Maintaining tray cleanliness aids in maintaining correct functioning of the
device.
It is recommended to clean the internal part of the tray once a week using
a mild, chlorine-free detergent that does not react with aluminium. After
cleaning, the tray must be thoroughly washed with water.
Dry the tray before reinstalling the tray and push it over the front face pins
and push it down gently to lock it.
Cleaning the process chamber
Maintaining the chamber cleanliness aids in maintaining correct function-
ing of the device.
It is recommended to clean the process chamber interior once a week us-
ing a mild, chlorine-free detergent. After cleaning, wipe the chamber with
a soft cloth until dry.
To clean the tray well it must be removed from the front of the device. To
do this, lift the tray gently up and pull it away from the front. The mounting
studs have notches in which the drawer ts.
Cleaning external surfaces
The external parts of the device should be cleaned using a soft cloth slight-
ly wet with water and a mild detergent (chlorine-free and not reacting with
plastics, varnishing coats and aluminum). Do not use strong detergents.
Use of mild detergents for maintaining the device does not aect the pos-
sibility of hazard related to toxic agents forming in contact with elements
of the device.
Cleaning the seal
It is recommended to clean the seal after 100 performed processes. Use
warm water and a microber cloth (microber with silver particles is ac-
ceptable) to clean the device. Use of dull or sharp cleaning tools is not
acceptable. Cleaning with chemical agents is not acceptable. Perform the
cleaning when the device has cooled down, after opening the drawer.
Maintain caution and do not bend the drawer. After cleaning, leave the
device open until the seal dries. During this time, protect the device from
damage. After cleaning and drying the seal, it can be lubricated with a sil-
icone lubricant.
Replacement of elements subject to wearing down
Elements subject to wearing down should be replaced periodically to en-
sure failure-free operation of the sterilizer.
MOUNTING STUDS

18 19
A message on the screen will notify the user when individual elements
should be replaced.
During regular operation, info screens concerning replacement of individ-
ual elements or required service inspection are displayed alternately. They
are described in detail in the „Warning messages and error codes”section.
In order to ensure ecient sterilization and correct operation of the
device, it is recommended to observe the replacement dates for el-
ements subject to wearing down.
Cleaning the water container
In order to ensure correct parameters of the water supplying the device,
it is recommended to check the water tank at least once per month. If
any contamination is found, the tank should be drained, cleaned and
relled with new, fresh and clean deionized or demineralized water.
6.1 Replacement parts
The following table includes elements subject to periodic replacement, and
elements subject to natural wear and tear. Replacement parts should be or-
dered directly from the manufacturer. Use of other replacement parts voids
the warranty and does not guarantee correct functioning of the device.
Name Part no.
Front seal ST1-UL1
Bacteriological lter DZ0035
Connection/water supply tube ST1-HW1
Connection/water supply tube ST1-HW2
Rubber plug for the water
container ST1-KS1
Rubber plug for the condensate
container
ST1-KS2
6.2 Periodic inspections
In order to ensure correct functioning of the ENBIO S sterilizer, it is recom-
mended to perform periodic service inspections and replace parts subject
to wearing down in accordance with the following schedule, and periodic
inspection of individual sterilizer elements in accordance with the follow-
ing guidelines.
Name Replacement frequency
Bacteriological lter every 1000 cycles or every 12
months
Connection/water removal tube if damage is observed
Plugs for water/condensate
containers if damage is observed
Element subject to inspection Inspection frequency
Front seal weekly or in the event of incor-
rect functioning – performed
by the user
Bacteriological lter weekly – performed by the user
Connection/water removal tube weekly or in the event of incor-
rect functioning – performed
by the user
Container plugs weekly – performed by the user
7. DATA ARCHIVING
The progress of each performed sterilization is automatically saved on a
data carrier (USB drive). The data can be used only for archiving, the sterili-
zation process correctness is directly communicated by the device.
The USB port is located on the rear panel of the device. It is recommended
to periodically archive the data on another carrier, e.g. a desktop PC, laptop.
We strongly recommend using the USB drives supplied together with
the device. Nevertheless, if user want to use their own USB drive, it is
required to use drives with following specication: minimum 16 GB
capacity, FAT32 le system.
It is not possible for the user to upgrade or downgrade the sterilizer's
control software - this task can be performed only by Enbio.
8. ENBIODATAVIEWER
The EnbioDataViewer software enables viewing and archiving sterilization
programs on a computer, and printing them.
Minimum requirements for installing the software:
Operating system – Windows – at least Windows 7 or newer
Free disk space – at least 100 MB
Minimum CPU parameters – at least 1 GHz
Minimum RAM – at least 512 MB
Screen resolution – at least 1200 x 720 or more
Using up-to-date antivirus software – strongly recommended.
The software is delivered with the device and can be found on a remov-
able disk - the USB ash drive or the latest version can be downloaded
from the manufacturer’s website https://enbio.com/media/rmware/
EnbioDataViewer.zip.
USB PORT

20 21
8.1 Software installation
To install the software, double click on the software installation le.
After performing this operation, the installation window regarding the lan-
guage selection will be displayed
After conrmation, you must accept the license terms for the installed
software.
Next, the information about placing the software shortcut on the comput-
er desktop will be displayed.
After making your selection, click „Next”. By clicking the Install button you
will install the EnbioDataViewer software.
After installation, the following message is displayed.
We can now run the software or nish the installation without running the
software by clicking the Finish button.

22 23
The main program window is displayed.
EnbioDataViewer updating procedure
1. Run Enbio Data Viewer software.
2. At main screen of Enbio Data Viewer click “Help” button and then “About the
program”.
3. At new window choose „Check the current software version”.
4. The Enbio website will open automatically, from which you should download the
latest version of the EnbioDataViewer program – by clicking in “Download” button
5. Unpack downloaded .zip le
6. Double click on the le to start updating the program.
7. Select the language used during the installation and click “OK” button.
8. Read the License Agreement and if you agree, click the "Next" button.
9. Check option „Create a desktop shortcut” if you want to, and click the "Next"
button.
10. The summary of the installation will be displayed.
11. Click the "Next" button and the update will be performed automatically.
12. After the installation is complete, a summary will appear.
13. Check option “Launch EnbioDataViewer” if you want to run the program and
click “Finish” button.
14. Update is nished. Current version of software can be checked by using “Help”
and then “About the program”button.
8.2. Program construction and main functionalities
The main window consists of three main areas
The dark blue color has been marked with function keys, e.g.
„PDF Report” that will allow you to print a protocol from the process.
All processes,
which have been
synchronized
from pendrive
were sorted
by the dates of
performance
Temperature and pressure diagram
together with the main data regarding
autoclave and process (date of
completion).
Data on the subsequent
stages of the process.
The most important para-
meters of sterilization.
The ability to save a note
for each process.
Drop-down menu:
By clicking on the File window we have access to the options:
• Loading the saved process ow from the memory of the USB ash
drive or from another location
• Printing a saved program
• Implementation of the report to a PDF le
• Export data to the database to get in case of problems
send it to the manufacturer
• Exporting data to CSV format
• Closing the program
By clicking on the Tools window we have access to the options:
• Synchronization of all les with saved programs from the memory
of the USB ash drive
• Search for any saved process from the database
• Adding your own logo to PDF reports

24 25
By clicking on the Help drop-down menu, you have access to the
options:
• About program
Search
The program allows you to search for processes after:
• Range of dates
• Sterilization number
• The type of process
• Result
PDF report
The program allows you to generate a report from every process
performed by the autoclave. It contains all necessary process data and
the result of sterilization.
9. WARNING MESSAGES AND ERROR CODES
If any irregularities in the device’s operation occur, the screen will display
relevant warning messages and error codes.
9.1 Warning messages
The element subject to replacement is highlighted in red, the screens are
displayed alternately.
Screens concerning seal replacement, with the number of processes re-
maining until replacement.
Screens concerning lter replace-
ment.
9.2 Information codes
Screen for overpressure or underpres-
sure resulting from natural chamber
cooling processes.
Message resulting from interruption
of the process after the sterilization
stage - during drying.

26 27
9.3 Error codes
The following table includes the error codes that may be displayed during
the use of the sterilizer.
Error code Description Recommendations
1 “Chamber over
temperature”
Maximum tempera-
ture in the chamber
exceeded
Contact the service
2 “Steam gen. over
temperature”
Excessive steam
generator
temperature
Contact the service
3 “Process over tem-
perature”
Excessive process
temperature
Contact the service
4 “Overpressure error” Pressure error Contact the service
5 “Sterilization pressure
too low”
Pressure too low
during sterilization
Check water level and
connection.
Contact the service
6 “Sterilization temp.
too low”
Sterilization
temperature too low
Check water level and
connection.
Contact the service
7 “Too high pressure
during drying”
Pressure too high
during drying
Check if the outlet
tube is not submerged
in water.
Contact the service
8 “Too many steam
pulses/no water”
Too many steam
impulses.
No water supply.
Check water supply
level and tubing
connections.
Contact the service
9 “Drainage error” Drainage clogged Check wastewater
level and tubing
connections.
Contact the service
10 “Chamber heating
error”
Chamber heating error Contact the service
11 “Steam generator
heating error”
Steam generator error Contact the service
12 “Prevacuum fail/check
condensate outlet”
Vacuum pump/
drainage error
Check wastewater
level and tubing
connections.
Contact the service
13 “Power failure” Temporary power loss
during operation
Conrm error.
14 “Pressure during
standby”
Pressure exceeded
during standby
Conrm error.
Contact the service
15 “Locking door error” Door lock error Contact the service
16 “Unlocking door error” Door unlocking error Contact the service
17 „Valve V3 / HEPA lter
error”
V3 valve / HEPA lter
error
Check lter cleanli-
ness/replace lter.
Contact the service
18 “Pressure sensor error” Pressure sensor error Contact the service
19 “USB disc error /
Change disc”
Write error on the USB
ash drive - media
damage
Write error on the USB
ash drive - damage to
the media. Rip content
from the current
pendrive - purchase of
a new one and use of
a new one
31 “Internal ash error” Memory error Contact the service
Info
„Aborted by user” Process aborted by the
user. Non-sterile insert
if interrupted during or
before the sterilization
process.
„Vacuum test failed” Vacuum leak test error Contact the service
„No USB memory” No USB drive Check the USB port,
insert the drive.
Contact the service
„Equalizing pressure” Pressure during
stoppage. Equal to
atmospheric pressure
The message occurs
in specic cases as
a result of natural
processes.
In the case of a
frequent appearance
of a message, contact
the service.
Sample error codes are presented below.
Process aborted by the user.
Screens displayed alternately: equalising pressure, please stand by.
The process has not been completed
correctly. The load is not sterile.
Vacuum leak program error. Error
screen: you can continue working.
Error no. 5
Pressure in the process chamber too
low.
The process has not been complet-
ed. The load is not sterile. Equalising
pressure in the process chamber.
10. WARRANTY CLAIM HANDLING
In order to report a problem with the device, call to [phone]. If
the device has been damaged during transport, le your warranty claim
with the delivery note and photographic evidence of the damage found.
ATTENTION! The warranty claim process will begin once our Tech-
nical Service receives a properly completed Warranty Claim Form.
If you send the device to the Technical Service, clean the chamber and tray,
perform decontamination and correctly secure the device for transport.
Preferably send the device in the original packaging. If you lack an appro-
priate packaging, please contact the Technical Service or your supplier.
If the device needs to be transported:
• Disconnect the demineralised water and condensate tubing.
• Wait until the process chamber cools down.
• Use the original or other appropriate packaging with protection lining.
The sender bears complete liability for damage during transport to the
Technical Service.

28 29
11. WARRANTY TERMS AND CONDITIONS
ENBIO sterilizers are covered by a standard 12-month warranty. Detailed
warranty terms and conditions are available from the supplier of this device.
12. TECHNICAL INFORMATION
Technical data ENBIO S
Power supply 110-120 V/60Hz
Installed power 1.6 kW
Maximum electric current consumption 15 A
Operating pressure 2.1 bar / 30.5 psi
Maximum pressure 2.45 bar max / 35.53 psi
Maximum process temperature 137°C (278°F)
Process chamber capacity 2.7 l / 0.7 gal
Mass 15 kg / 33 lb
Process chamber dimensions (LxWxH) 292 x 192 x 45 mm /
11.4 x 7.5 x 1.8 in
External device dimensions (LxWxH) 561 x 252 x 162 mm /
22 x 9.8 x 6.3 in
Protection rating IP20
Noise level 49dB
Process data archiving USB drive
Surrounding conditions:
Operating temperature range from +5°C to +40°C /
from +41°F to +104 °F
Relative humidity 0-90%
Storage temperature range from -20°C do +60°C /
from -4°F to +140°F
Relative humidity 0-90%
Surrounding pressure range 900 - 1100 hPa /
26.5 - 32.4 “Hg
Rating plate located on the bottom of the device.
Test connector - to be used by authorized service only.
If it is determined that the user has used it, the warranty will be voided.
Chamber volume 2,7 dm3
Max. working pressure 2,45 bar
Max. working temp. 137°C
Pressure test 12,0 bar
Sterilization process parameters
Max. pressure 2,1 bar
Min. pressure -0,9 bar
Max. temperature 134°C
Chamber characteristic
Conforms to UL Std. UL 61010-1
Cerrfied to CSA Std. C22.2 NO. 61010-1
Conforms to UL Std. UL 61010-2-040
Cerrfied to CSA Std. C22.2#61010-2-040

30 31

Manufacturer:
Enbio Group AG
Eichengasse 3,
4702 Oensingen, Switzerland
www.enbio.com