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.