Operation Manual SM ECO ABC Bioair
Operation Manual SM ECO ABC Bioair
Operation Manual SM ECO ABC Bioair
OPERATING MANUAL
PART 1: USER
PART 2: INSTALLATION AND MAINTENANCE
ORIGINAL INSTRUCTION
80.021.210 Revision 00 April 2021
BioAir S.p.A.
Head Offices and Manufacturing Plant: Via Lombardia, 12 - 27010 Siziano (PV) Italy
www.bioair.it - info@bioair.it
BioAir has a Quality System certified in compliance with EN ISO 9001
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SafeMate Eco ABC Operating Manual
ORIGINAL INSTRUCTION
CONTENTS
GENERAL INFORMATION 7
FOREWORD TO MANUAL 7
MARKING 8
WHAT IS SUPPLIED INSIDE 8
MEANING OF SYMBOLS 9
GLOSSARY 10
WARRANTY AND LIABILITY 10
DEFINITION OF IMPROPER USE 10
CABINET DEFINITION 10
INTENDED USE 11
NOT ALLOWED USE 11
DECLARATION OF CONFORMITY 12
APPROVALS AND CERTIFICATIONS 12
CONTACTS 13
PART 1: USER 15
1. ASSESSMENT OF RISKS 17
2. INSTALLATION 24
2.1 CHOICE OF LOCATION 24
2.2 FLOOR STAND 25
2.2.1 Restrictions on adjustable stand use 25
2.3 CONNECTING TO THE MAINS 26
2.3.1 Mains supply cord 27
2.3.2 Mains socket 27
2.3.3 Appliance mains inlet and main fuses 28
2.4 CONNECTION OF GAS LINES (OPTIONAL) 28
2.5 EXHAUST AIR TREATMENT 28
2.6 FINAL PROCEDURES 29
3. TECHNICAL DATA 30
3.1 POWER SUPPLY 30
3.2 REFERENCE STANDARDS 30
3.3 DECLARATIONS AND APPROVALS 30
3.4 USE ENVIRONMENTAL CONDITIONS 31
3.5 TRANSPORT AND STORAGE CONDITIONS 31
3.6 WEIGHT AND DIMENSIONS 31
3.7 PERFORMANCES 32
3.8 MATERIALS 32
3.8.1 METAL PARTS 32
3.8.2 GLASS PARTS 33
3.8.3 FILTERS 33
3.8.4 LIGHTING (2) 33
3.8.5 UV-C LAMP 34
3.9 OUTLET 34
3.9.1 SERVICE SOCKETS 34
3.9.2 CONNECTOR VFC 34
3.10 OPTIONAL ACCESSORIES FEATURES 34
3.10.1 FLOOR STAND 34
3.10.2 INERT FLUIDS UTILITY 35
3.10.3 FLAMMABLE GAS UTILITY 35
3.10.4 LED LIGHTING 35
3.11 ORDINARY OPTIONALS 36
4. OPERATING PRINCIPLE 37
5. OPERATING INSTRUCTIONS 38
5.1 CABINET DESCRIPTION 38
5.1.1 Lighting 39
5.1.2 Service sockets 39
5.1.3 Front window 40
5.1.3.1 FRONT WINDOW MOVEMENT JAMMING 40
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SafeMate Eco ABC Operating Manual
ORIGINAL INSTRUCTION
GENERAL INFORMATION
FOREWORD TO MANUAL
Original instructions.
In case of a disagreement between the translation and the original version of this manual or a notice or
disclaimer, the original English version will prevail.
This manual is intended to provide the USER with instructions for use and to provide the SERVICE with
installation and maintenance instructions, for the following cabinet family:
Model: +
SafeMate Eco ABC
Size: 0.9 0.9 0.9 0.9
Code: LDM3802 LDM4802 LDM5802 LDM6802
The use of this equipment is limited by what is described in the paragraphs CABINET DEFINITION,
INTENDED USE and DEFINITION OF IMPROPER USE.
WARNING!
The operating manual is an integral part of the machine and it refers to the above cabinet
codes only.
Special versions of this cabinet with different code could be partially covered by this
manual, but they could also need additional instruction to add or substitute parts of this
manual.
In order to make the guide as complete and comprehensible as possible, the utmost care
has been taken in the collection and verification of the documentation contained in this
manual, but it is not designed to act as your procedure manual or act as a substitute for
validation of your own procedures.
The cabinet code is printed on the data label (see MARKING).
Unless otherwise specified, the information contained in this manual is applicable to all
codes listed above.
Read the manual before starting ANY ACTIVITY involving the machine, including its
handling, installation and maintenance.
The instructions given in this Manual shall be carefully read and understood before
switching this equipment on before you operate it, in order to become familiar with its
operation and function, and to avoid an IMPROPER USE.
This manual should always be available in the operating area of the cabinet, in order to be
quickly consulted for use and service (routine checks and maintenance, and must
accompany it from the time of its manufacture until its dismantling, in the event of
relocation, sale, etc.
In case of special cabinets derived from this model, consult the dedicated manual or the
supplementary manual referring to the code of the special cabinet.
For a better consultation, the operating manual is divided into the following sections:
Part 1: containing the use instructions for the OPERATOR.
Part 2: containing installation and maintenance instructions, intended solely for suitably trained
TECHNICAL personnel authorized to work on the cabinet.
BioAir reserves the right to modify or update the content at any time without prior notice.
Nothing contained in this manual can be considered as a warranty, either expressed or implied,
including, not in a restrictive way, the suitability warranty for any special purpose.
Nothing contained in this manual can be interpreted as a modification or confirmation of the terms of
any purchase contract.
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MARKING
On the right side of the control box of every apparatus (see 5.1 - Pic. 15 – item 4) a label is placed with
the following important information as shown in the example below (Pic. 1):
Logo
Name of manufacturer
Address of manufacturer
CE Mark (for European Market only)
Model
Code
Voltage, Frequency, Power
Warnings (3)
Serial number
Year of manufacturing
Standard conformity (1)
Competent Body Mark (2)
Factory use code (4)
Pic. 1
Do not remove this label.
For any enquiry relevant to service or spares parts, please always communicate the data on this label
relating to CODE, MODEL and SERIAL NUMBER.
Flammable gas
This manual Short instruction tap install kit
80.021.210 Shelves extractor Control panel keys adhesive label 80080159
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SafeMate Eco ABC Operating Manual
ORIGINAL INSTRUCTION
MEANING OF SYMBOLS
GENERAL WARNING
CAREFULLY READ THE MANUAL BEFORE USING
DISCONENCT THE CABINET FROM THE MAINS (by means of power cord plug)
User information
1
IMPORTANT NOTE
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SafeMate Eco ABC Operating Manual
ORIGINAL INSTRUCTION
GLOSSARY
Apf: Aperture protection factor.
BSC: Biological Safety Cabinet.
DOP: Dispersed Oil Particle.
EMC: Electromagnetic Compatibility.
EMI: Electromagnetic Interference.
Exh: Exhaust air flow.
HEPA: High Efficiency Particulate Air.
LAF: Laminar Air Flow.
MPPS: Most Penetrating Particle Size.
PPD: Personal Protection Device
SDS: Safety Data Sheet
SOP: Standard Operating Procedure
TLV: Threshold Limit value
UPS: Uninterruptible Power Supply
UV-C: Ultraviolet radiation (range C - germicidal).
VFC: Voltage Free Contact.
CABINET DEFINITION
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The definition of the cabinet SafeMate Eco ABC is the following:
CLASS II BIOLOGICAL SAFETY CABINET (BSC)
FOR PERSONNEL, ENVIRONMENT AND PRODUCT PROTECTION as per AS 2252.2-2009
NOT DESIGNED FOR USE WITH FLAMMABLE, EXPLOSIVE OR HIGHLY VOLATILE LIQUIDS, CYTOTOXIC
DRUGS OR TOXIC COMPOUNDS.
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ORIGINAL INSTRUCTION
INTENDED USE
The purpose of the cabinet is to provide protection from hazardous biological agents for personnel and
the environment and also to protect material used in the cabinet from exogenous contamination.
This cabinet (hereinafter also named BSC) is designed to reach the following targets during the
handling of biological agents and hazardous or potentially hazardous microorganisms:
reducing of the risk to the operator
protection of the environment
protection of the product against environmental and cross contamination risk
NOTE: the categories of etiological agents are defined by the statutory legislation in your country.
Reference to the listed classes of microbial species in order to assess which ones can be handled in this
BSC.
THE MANUFACTURER DECLINES ALL CRIMINAL AND CIVIL LIABILITY FOR DEFECTS FOUND AND
FOR DAMAGES CAUSED TO PERSONS AND/OR THINGS DUE TO MISUSE, UNAUTHORIZED USE,
TAMPERING OR ANY GENERAL USE OF THE EQUIPMENT THAT IS NOT PERMITTED OR THAT DOES
NOT COMPLY WITH THE OPERATING INSTRUCTIONS CONTAINED IN THIS MANUAL.
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DECLARATION OF CONFORMITY
The Manufacturer:
BioAir S.p.A.
Via Lombardia, 12
27010 Siziano (PV) - Italy
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MODEL: SafeMate Eco ABC
SIZES: 0.9 - 1.2 – 1.5 - 1.8
CODES: LDM3802 - LDM4802 - LDM5802 - LDM6802
IEC 61326-1:2012 Electrical equipment for measurement, control and laboratory use
- EMC requirements - Part 1: General requirements.
NOTE: obtained approval marks refer solely to the standard cabinet, floor stand, germicidal UV-C
light and installation in "recirculation of exhaust air in the environment" mode.
Changes or different configurations invalidate the approval markings obtained.
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ORIGINAL INSTRUCTION
CONTACTS
If you require any further information or explanation regarding the contents of this manual, and for any
request relevant to
service
spare parts
technical enquiries
contact:
sat@bioair.it sat@bioair.it
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PART 1:
USER
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Part 1: User
ORIGINAL INSTRUCTION 1
1. ASSESSMENT OF RISKS
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SafeMate Eco ABC is a Class II Biological Safety Cabinet according to AS 2252.2—2009.
NOTE 1: notwithstanding conformity with the above standard, during operating of the cabinet some
residual risks remain and were assessed in order to indicate the measures to be taken to prevent the
hazards arising from normal use and foreseeable misuse.
The risks considered are the following:
General
Misuse
Electric shock
Biological
UV-C radiations
Pinch
Spread of fire from the equipment
Liberated gases and explosion
The analysis was done as per IEC 61010-1:2010/A1, 7.3.3 and Annex J.
The residual risks have been assessed as per the following Tab. 2:
Tab. 2 – Risk Category
CATEGORY ASSESSMENT DESCRIPTION
1 Broadly This Category fulfils the requirement for tolerable risk.
acceptable.
2 As low as This Category does not automatically fulfil the requirement for
reasonably tolerable risk. If possible, reduce these risk to Category 1.
practicable.
If not possible, then the instructions should contain a description of
the risk so that the Responsible Body can take appropriate steps to
protect the safety of operators.
3 Intolerable. This category contains risks that are not tolerable risks.
NOTE 4: other risks associated with transportation, installation, electrical connection, installation of
accessories, as well as maintenance and/or service in general, are also described in Part 2 in the
relative paragraphs.
THE MANUFACTURER DECLINES ALL CRIMINAL AND CIVIL LIABILITY FOR DEFECTS FOUND
AND FOR DAMAGES CAUSED TO PERSONS AND / OR THINGS DUE TO MISUSE,
UNAUTHORISED USE, TAMPERING OR ANY GENERAL USE OF THE EQUIPMENT THAT IS NOT
PERMITTED OR THAT DOES NOT COMPLY WITH THE OPERATING INSTRUCTIONS CONTAINED
IN THIS MANUAL.
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PRECAUTIONS TO BE TAKEN:
Read the instructions regarding the use of germicidal UV light (see 5.1.4).
Prevent access to the place where the cabinet is installed to unauthorised
people or general public.
Authorize the use of this BSC only to trained and informed personnel.
Keep the key of the switch in a safe place to avoid the possibility of using the
cabinet by unauthorised personnel.
Use spare UV-C lamp recommended by BioAir only.
DO NOT plug any additional UV-C fixture to the service socket.
Do not stand close to the cabinet with the UV-C light on and visible, either
direct or reflected (see 5.1.4.1).
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WARNING!
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WARNING! NOTE:
hydrogen peroxide is toxic by inhalation, in contact with skin and if
swallowed;
causes serious eye damage;
the threshold limit value (TLV) in the air varies according to the
legislation of your Country.
Taken measures to reduce the risk:
Warning marking (caution) is provided on the cabinet.
Adequate information for user.
PRECAUTIONS TO BE TAKEN:
Check the TLV or TWA allowed by the legislation of your Country.
Decontamination shall be carried out exclusively by specialized and authorised
staff, following the instructions listed in par. 9 (PART 2 of this manual).
Read the safety data sheet of the decontaminant used in advance.
Personal protective equipment (PPE) should be available on the spot to protect
the personnel against the risks indicated.
DO NOT stay in the room during decontamination activity.
Provide adequate equipment for reading the concentration of H2O2.
Consult safety officer for precautions requested by local authorities.
If another decontamination method is chosen, perform a risk analysis related to
the dangers deriving from this other method.
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2. INSTALLATION
WARNING!
This cabinet is not suitable for operating in:
residential areas.
On receiving the equipment make sure that the supply corresponds to what has been ordered.
In case of non-compliance report immediately to BioAir (see CONTACTS).
Also check it has not been damaged during transport.
WARNING!
This cabinet is supplied “NOT READY TO USE”.
See ASSESSMENT OF RISKS, warning 1.1
The operations required for installation and commissioning (unpacking, positioning,
assembly, connection to the mains power supply, installation of optional accessories and
testing) must only be carried out by specialized and authorized personnel, in accordance
with the instructions listed in PART 2 of this manual.
Ask your dealer or BioAir for commissioning.
THE SAFETY OF ANY SYSTEM INCORPORATING AND/OR INTEGRATES THIS CABINET IS THE
RESPONSIBILITY OF THE ASSMBLER OF THE SYSTEM.
THE MANUFACTURER DECLINES ALL CRIMINAL AND CIVIL LIABILITY FOR DEFECTS THAT ARE
MANIFESTED AND FOR DAMAGE CAUSED TO PERSONS AND/OR THINGS DUE TO NON-
AUTHORISED INSTALLATIONS AND/OR WHICH ARE NOT COMPLIANT TO THE OPERATING
INSTRUCTIONS CONTAINED IN THIS MANUAL.
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NOTE: the use of other ways to support the cabinet is discouraged and is under full the
responsibility of the customer.
WARNING!
This operation should be carried out by service specialized and authorised personnel.
Installation must be carried out in accordance with the instructions in the Part 2 of this
manual (see 8.3.1.1 and 8.3.1.2) and in accordance with the instructions supplied with the
accessory.
THE SAFETY OF THIS CABINET DEPENDS ON THE CORRECT INSTALLATION OF THE ACCESSORIES
ACCORDING TO WHAT IS INDICATED IN THIS MANUAL AND IT IS THE RESPONSIBILITY OF THE ASSMBLER.
The support is available in the list of optional accessories in fixed or adjustable height version.
Height and other features of the stands are indicated in 3.10.1.
NOTE 1: the result of the stability test allows the use of the support in combination with the
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SafeMate Eco as per height limits shown in Tab. 3.
The stability tests were made in accordance with IEC 61010-1 paragraph 7.4.
NOTE 2: the choice should be defined at installation phase. Any variations must be carried out
by qualified and authorised technical personnel.
0.9
1.2
1.5
1.8
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WARNING!
See ASSESSMENT OF RISKS, warning 1.1
The user should not connect the cabinet to the mains before commissioning and final
testing.
The first connection should be carried out only by authorised personnel in accordance with
the instructions in the Part 2 of this manual (see 8.5).
The cabinet is designed to operate in the range defined by the technical data sheet (see 3.1)
and in the environmental conditions indicated in 3.4.
Check that the mains voltage matches what shown on the data plate of the cabinet.
Use a dedicated power line equipped with a ground connection that complies with local
regulations.
The magneto-thermal protection to be used on the power line is indicated in Part 2 of this
manual (see 8.5).
If using an uninterruptible power supply (UPS), read the information in Part 2 of this
manual (see 8.5).
Then proceed as follows:
1. Plug the female connector (Pic. 5 – item 1) of the supply cord (2.3.1) to the appliance inlet (Pic. 7 -
item 1).
2. Insert the clamping hook (Pic. 6) into the threaded insert (Pic. 7 - item2) by screwing it firmly to
the top of the connector in a slightly forced (hand) manner.
3. Connect the plug (Pic. 5 – item 2) of the supply cord (2.3.1) directly to the
dedicated mains socket (2.3.2).
Pic. 8
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AUSTRALIA
Pic. 9
BioAir may supply on request the following optional detachable supply cords:
WARNING!
An unsuitable or defective mains supply cord compromises the safety of the cabinet.
PRECAUTIONS TO BE TAKEN:
Do not cut the cord to replace the plug or connector.
In case of incompatibility with mains socket or damage of the
cord, plug or connector, ask the maintenance staff to replace the
complete cable with a certified type and with the characteristics
indicated in Tab. 8.
WARNING!
The means for disconnection of the BSC from the mains is the plug of the supply cord.
The mains socket to be used should be choosen by specialized and authorised technical
personnel, in compliance with the instructions also given in Part 2 of this manual (see
8.5.1).
PRECAUTIONS TO BE TAKEN:
The mains socket should be dedicated and located as close as possible to the cabinet
(max 2 m) according to the length of the supply cord (do not use extension), but out
of the reach of the user’s arms (to avoid the cabinet be switched off accidentally).
Mark the socket as exclusive use for this BSC.
Neither objects nor furniture should be hidden the connection in order to can quickly
disconnect the cabinet in case of emergency.
The technical features are available in Tab. 7.
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The appliance inlet (Pic. 10) is placed on the right top of the
control panel (see Pic. 15 – item 1) and consists to a male
connector (IEC 60320 C14) with a fuse holder for two main
fuses (Pic. 11).
The main fuses are replaceable from the outside, located in
the inlet appliance.
A label close to the appliance inlet reports the values of the Pic. 10 Pic. 11
fuses (see Pic. 12).
Fuses rating are also available in the table of specifications
(see 3.1):
Pic. 12
On the cabinet there are two lines for technical gases and vacuum.
To take advantage of these utilities, specific (optional) taps must be installed, supplied separately in the
installation KIT (see 5.1.5).
On the flammable gas line must be installed the solenoid valve provided in the dedicated installation KIT.
WARNING!
The operation should be carried out exclusively by service specialized and authorised personnel.
Installation must be carried out in accordance with the ruling standards and the instructions
given in both Part 2 of this manual (see 8) and in those su supplied with the accessory.
The installer must issue a test report for the activation of these lines.
THE SAFETY OF THIS CABINET DEPENDS ON THE CORRECT INSTALLATION OF THE ACCESSORIES
ACCORDING TO WHAT IS INDICATED IN THIS MANUAL AND IT IS THE RESPONSIBILITY OF THE ASSMBLER.
Both in the case of installation and removal of this modification, the cabinet should be
validated by qualified personnel.
CHANGES LIKE THIS OR DIFFERENT CABINET CONFIGURATIONS WILL VOID ANY APPROVAL
MARKING IF APPLICABLE.
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WARNING!
Before the first use of this BSC an efficiency test (installation testing) shall be carried out as
per AS 2252.2—2009, paragraph 5.2 (Critical performance tests for cabinet function) and Part
2 of this manual, paragraph 8.7, by a qualified and authorised staff, with the issue of an
installation report to be kept along with the documentation of the cabinet.
This makes it possible to exclude any damage caused by transport or the installation itself,
which could affect the good operating and the safety of the cabinet.
The test should be performed by qualified and authorised staff, with the issue of relevant
report to be kept along with the documentation of the cabinet.
WARNING!
Do not operate this BSC without installation report.
Once installation is over, carry out the final procedures before starting work:
turn on the cabinet in MODE 2 (see 5.2.2) and open the front access area lifting the
window by the relevant key (see 5.1.7.8);
turn off the cabinet and disconnect it from the mains (see 5.2.3.2).
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ORIGINAL INSTRUCTION
1
3. TECHNICAL DATA
DESCRIPTION SIZE 0.9 SIZE 1.2 SIZE 1.5 SIZE 1.8
Mark of conformity:
-
Approvals:
-
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3.7 PERFORMANCES
Intended life of the equipment (years): 10
Laminar Air Flow mean velocity [AS 1807.1](m/s): 0.40 ÷ 0.45
Inflow Air Barrier mean velocity [EN 12469](m/s): 0,85 ±10%
3
Exhaust Air flow rate (m /h): 450 ±10% 550 ±10% 700 ±10% 800 ±10%
Exhaust Air flow ratio (%): 35 ±10%
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4. OPERATING PRINCIPLE
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SafeMate Eco ABC is a cabinet of the type “VERTICAL LAMINAR AIRFLOW WITH PARTIAL
RECIRCULATION”, which provides protection for the operator, for the environment and for the product.
The effectiveness of this cabinet depends on several factors:
location and installation test;
training of personnel involved in the use;
proper use and correct working procedures;
correct handling of biological agents according to current regulation;
routine and periodic maintenance; and
routine performance testing (see 10.1.1).
The working area (Pic. 14 – item 1) is crossed
by a vertical unidirectional air flow
(DOWNFLOW, Pic. 14 – item 2).
This airflow is part of what supplied by a
motorblower (Pic. 14 – item 3), which blows into
a plenum (Pic. 14 – item 4) distributing the air
as follows:
about 70% (Pic. 14 – item 11) conveyed
into the working chamber through an
absolute filter HEPA H141 (Pic. 14 – item
5) to create a sterile area in laminar flow
(LAF) in which the product is protected
from external and cross contamination;
Both airflows are mixed by the suction of the fan, forming 100% of the (contaminated) airflow in the rear
intake duct (Pic. 14 - item 10) to repeat the cycle (Pic. 14 - items 11 and 12).
All potentially contaminated areas within the BSC that are at positive pressure are surrounded by zones of
negative pressure relative to the workroom atmosphere.
(1) HEPA H14 filtration assures both the air sterility of the working space and the air sterility of the
exhausted air.
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5. OPERATING INSTRUCTIONS
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5.1.1 Lighting
The working chamber is lighted up by two
fluorescent lamps through the front window.
Alternatively, LED lighting can be installed on
request.
Location: inside the control panel (Pic. 15 -
item 18), out of the working area (see Pic.
16).
The values relating to the illumination of the
work area are available in 3.8.4.
It is activated in both MODE 1 and MODE 2 by
On the front wall of the working chamber there are two service sockets (see Pic. 17).
Location: see Pic. 15 - item 16.
To activate and deactivate
them, press the relative key
on the control keypad (see
5.2.1.2).
Technical features and the
limit of use are available in
3.9.1.
The supply voltage supplied
is the same as the mains.
Maximum current allowed (3
A) can be used on a single
socket or distributed
between two sockets.
Pic. 17
They are controlled simultaneously via the key (SOCKET) on the control
keypad, in both MODE 1 and MODE 2. Pic. 18
Other types of electrical socket are available on request, as shown below:
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The front window is made of laminated safety glass (two layers) and is part of the cabinet
enclosure: in addition to being a protection for the operator against UV-C radiations, constitutes
a decisive factor for the containment efficiency of frontal barrier (INFLOW).
Location: see Pic. 15 - item 10.
The breakage of the window compromises both the UV-C radiations protection and the air
barrier containment.
The front window (Pic. 19 – item 4) is sliding and it’s electrically
NOTE: the height of the opening corresponding to the working position determines the
velocity of the intake air through which the containment barrier is guaranteed to protect the
operator, without the risk of investing the product worked inside.
For this reason the working position height can not be changed.
During MODE 1 operating (see 5.2.1), any position of the window other than the working one
will active the alarm.
If the downward movement should stop to positions other than those provided in 5.1.3
despite pressing the dedicated key, do not insist and proceed as follows:
1. push the key (UP) for at least 2 seconds, since the window rises again;
2. then push the key (DOWN) and try to lower the window;
NOTE 1: if the problem persist shut down the cabinet, remove the key from the switch
and call service.
NOTE 2: in case a message appears as shown in Pic. 48, proceed in the same way.
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NOTE 1: UV radiation is
not recommended for use in
BSCs (see EN 12469, annex
A.2).
Pic. 22
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WARNING!
In case of access to biologically contaminated area, this sterilization method is not
adequate.
PRECAUTIONS TO BE TAKEN:
In the event of a substantial spillage of contaminated liquids, in cases of technical
assistance and maintenance involving the replacement of filters or fan motors, and
before routine controls it is necessary to have an effective and complete
decontamination of the cabinet, with a validated method.
See par. 9 for information and decontamination method proposed by BioAir.
NOTE 2: the fact that UV lamp is producing light is not directly related to its actual
neutralising power on microorganisms. The actual efficiency may be tested with proper devices.
On request it is possible to perform a test of efficiency of radiation emitted by the UV-C lamp:
contact your BioAir distributor.
WARNING!
We do not recommend long stays or workstations that can be reached by direct or
reflected UVC light.
PRECAUTIONS TO BE TAKEN:
If it is essential to remain in the same room during the operation of the UVC
lamp, it is the customer's responsibility to carry out a risk analysis to take the
appropriate measures.
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The taps can be installed individually or in pairs, in the configurations shown in Pic. 23 (item 1,
vacuum/inert-gas tap and item 2, flammable gas tap) or in Pic. 24 (items 1 and 2, taps for
vacuum/inert-gas).
NOTE 1: the installation of 2 flammable gas taps (see Pic. 25) is not allowed.
NOTE 2: the provision of gas supply is not recommended. Flames from gas burners interfere
with laminar airflow within the cabinet and may compromise containment.
Where practicable, disposable loops or use of electrical loop sterilizers are preferred to gas
burners.
PRECAUTIONS TO BE TAKEN:
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Non flammable pressurised fluids line is equipped with a fine regulation head-valve with PTFE
seal tap.
The tap knob is made of grey polypropylene with black central mark (see Pic. 23 - item 1).
Fluids used must be non aggressive towards materials of which the valve is made (body in
brass, gaskets in PTFE).
The tap is also suitable for vacuum (see also 5.1.5, 3) and compressed air.
Features and limits of use are available in 3.10.2.
Flammable gas line (see also 5.1.5, 1 and 2) is controlled by a normally closed solenoid
valve and a ceramic head-valve tap (with safety lock) in line.
Activation of the solenoid valve is only possible in MODE 1 (see 5.2.1) by pressing the key
NOTE 1: termination of alarm conditions and automatic or manual restart of the cabinet
after blackout will not reactivate the valve. Restore can only be performed manually with
ceased alarm.
This safety measure is in accordance with EN 12469 standard, annex A.9 and AS 2252.2,
clause 4.9 to prevent HEPA filter damage and possible risk of fire (see 1.12).
The tap knob is made of yellow polypropylene with yellow central mark (see Pic. 23 - item 2).
Features and limits of use are available in 3.10.3.
NOTE 2: the provision of gas supply is not recommended. Flames from gas burners
interfere with laminar airflow within the cabinet and may compromise containment.
NOTE 3: where practicable, disposable loops or use of electrical loop sterilizers are
preferred to gas burners.
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Pic. 28 Pic. 29
WARNING!
Operating outside the SAFE WORK AREA compromises operator safety and
product protection.
PRECAUTIONS TO BE TAKEN:
Operate only within the SAFE WORKING AREA shown as top view in Pic. 30.
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The key switch (Pic. 34) allows to switch ON/OFF the cabinet.
Location: see Pic. 15 – item 5
The key of the switch is removable in both ON (1) and OFF (0) position.
Reference: standard EN 12469, annex H.3.4.
Pic. 34
NOTE: the alarm condition is signalled, as well as acoustically, by a red pilot light on the
membrane keypad and indicated with . The signal can be fixed or flashing. In MODE 2 it is
always activated to signal the unsafe mode.
In MODE 1 the alarm is also audible.
A second red LED indicator (Pic. 35) with redundant function is present at
the bottom right of the control panel, with increased lateral visibility as it
slightly protrudes from the casing.
It is activated simultaneously with the membrane keypad pilot light.
Location: see Pic. 15 – item 7. Pic. 35
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5.1.7.6 Display
The display is located in the centre of the keypad (see Pic. 37) and it contains all the
information about the cabinet status.
UV-C light
UV: 2 YELLOW FIXED
activation/programming.
These keys are marked by the symbol (see Pic. 37) and control an electric winder that
allows opening and closure of the frontal access.
The key marked allows raising the window and the key marked allows lowering it.
More information is available in 5.1.3.
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KEYS
MODE SPECIAL FUNCTION DESCRIPTION
SYMBOL
2 Language selection.
+
Once you have chosen the special function, press the keys if necessary with the following
meaning (see Tab. 6):
DISPLAY NONE
ICON
(EXIT) (UP) (DOWN) (ENTER) -
KEY
MODE LIGHT UV SOCKET GAS
INCREASE DECREASE
FUNCTION EXIT ENTER NONE
PARAMETER PARAMETER
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NOTE 3: to turn off the cabinet in an emergency, in the absence of the key, remove the plug of the
power cord (see 2.3.1) from the mains socket (see 2.3.2).
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Before activating this mode, carefully read all PART 1 of the manual.
Before each start, check the correct positioning of the work surface.
The lighting can be switched ON and OFF via the key . See also 5.1.1.
The sockets are controlled simultaneously via the key . See also 5.1.2.
The solenoid valve for use of flammable gas is controlled by the key . See also 5.1.5.2.
MODE+GAS keys + .
The display will show the run hours from the last zero
setting of the counters (cabinet, filters, UV) (see Pic. 42).
Releasing the keys the display will return to SAFE
OPERATING message. Pic. 42
NOTE: the zero setting can be carried out at SERVICE level only.
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Check neither your arms nor objects are across the front aperture while
activating this mode.
NOTE 2: if the front window is jammed, or gets jammed, before or during the activation of
ECO MODE, the cabinet will automatically return to MODE 1 and display the screen of Pic. 48.
Once the reduced height of the front access and the set ventilation value have been
reached, the acoustic alarm goes out, while the visual one remains.
2. To exit ECO mode (restoring of MODE 1), press (MODE key) for 2 seconds.
An acoustic and visual alarm is activated to indicate the automatic movement of the front
window upwards to the work position of the front access.
At the same time the airflow will be increased to reach the configured value.
During MODE 1 restoring the display shows the Pic. 45 with acoustic and visual alarm on
until the cabinet is in operational safety conditions.
The lighting goes on.
The solenoid valve remains deactivated.
The service sockets remain in the state as they are.
Once the operational safety conditions have been reached, the alarm goes out and the
display shows the Pic. 41.
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In MODE 1 some warnings or alarms may occur (see from Pic. 44 to Pic. 53).
Pic. 52 Pic. 53
Audible and visual Visual alarm.
alarm. If the cabinet suffers a very short voltage dip, it
Due to absence of flow restarts automatically with restoration of the
sensor signal. previous conditions.
Shut down and close Assess whether this may have compromised the
the cabinet. work in progress.
Call SERVICE. Press a key to cancel the warning.
If the problem occurs several times, call
SERVICE..
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keys + .
The display will show the language menu (Pic. 56).
2. Select the language by pressing the keys.
3. Press key to confirm or press key to exit without Pic. 56
saving.
+ .
The display will show the date/time set up menu (Pic. 57).
2. Select data to modify by pressing the keys.
3. Press key to enable the modification of the data. Pic. 57
On the left of the selected data will appear an arrow.
4. Modify the value by pressing the keys.
5. Press to save and exit or press to abort and exit.
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5.2.3 SHUTDOWN
This operation does not guarantee disconnection from the mains (see 5.2.3.2).
1. Turn the switch to position O.
2. Remove the key from the switch and keep it in a safe place.
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Proper housekeeping and physical leaning of the facility is important for maintaining safe working
conditions for personnel, product and the surrounding environment.
Cleaning and sanitizing shall be carried out by trained personnel in accordance with specific, written, and
approved procedures (SOPs).
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Avoid that contaminated material passes over the sterile one when shifting it; keep contaminated
material separate from the sterile one, place the latter far from the working area and put the wastes
in a back corner of the working surface.
Do not place large or bulky equipment in this BSC and do not place equipment on ventilation grilles
to avoid disturbing airflow patterns.
Don’t obstruct the slots of the whole working chamber
(see 5.1.6.3) with objects (see Pic. 63) and especially
careful not to obstruct the front intake grille with
sleeves of the working garment.
Use this BSC only when the ventilation is operating
(MODE 1), with functioning display and in the absence
of alarm (acoustic or visual).
Limit the activities inside the room where the cabinet is
placed, because they could disturb the air barrier
containment and the laminar flow (LAF), with
consequent decrease in the operator and product level
of protection.
Each time doors of the laboratory are open and closed,
drafts are produced.
Pic. 63
Repeat the decontamination of inside surfaces once all
objects as materials and equipment have been taken out of the cabinet.
Pay special attention when removing cultures that have been accidentally poured inside the working
area: they could favour the growth of fungi and the spreading of their spores with consequent
contamination of the cabinet. For cleansing and decontamination, see par. 7.
Keep the cabinet on for at least 10 minutes once the work is over, in order to remove any
contaminating substance from inside.
Subject this BSC to routine checks as indicated by the manufacturer (see 10.1.1) or by regulatory
authorities, if more restrictive.
7.1 CLEANSING
WARNING!
Chlorine products damage stainless steel surfaces.
NOTE: to clean the inner area of the front window which is not normally accessible,
follow the procedure described in 7.1.3.1.
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Pic. 64 Pic. 65
1. In MODE 2 (see 5.2.2) make the lower edge (Pic. 64, items 1) of the front window
coincide with the point marked by a notch on the side cover (Pic. 64, item 2).
Pic. 68
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15. Reconnect the cabinet to the mains and proceed with normal use.
16. Return the control panel release key to the laboratory manager.
The exposed face of the laminar flow filter inside the work chamber is covered with a sheet of
micro-perforated polyester fabric with a surface treatment that has the task of making the
laminar flow as uniform as possible.
In case of splash contamination on this fabric, decontamination of the surface is possible using
isopropyl alcohol.
WARNING!
Carrying out this operation without care can damage the filter and compromise
product safety.
PRECAUTIONS TO BE TAKEN:
Perform this operation only if strictly necessary, in the event of an accident that
has caused splashes of contaminated substance on the fabric, very carefully and
gently.
Procedure:
with a soft piece soaked in isopropyl alcohol, gently rub the face of the filter without pressing on
the protective grille underneath.
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WARNING!
See ASSESSMENT OF RISKS, warnings 1.7 and 1.8
See 5.1.4.1
WARNING!
The procedure by UV-C radiation does NOT guarantee a real reduction of microbial
contamination, as it is effective only for the surfaces directly exposed to the radiation.
This method does NOT replace the conventional ones of decontamination of a BSC.
In the following cases use a valid decontamination method:
before accessing to any potentially contaminated area;
every time big spillage of contaminated liquids occurs;
before maintenance (fan and filters replacement);
before routine control;
before dislocation or decommissioning;
after any emergency.
The operator must identify the effective decontamination method against the pathogen in
question.
WARNING!
The breaking of UV and fluorescent lamps pose a risk of injury to the skin and eyes, as well as
pose a risk to health due to mercury vapour, metal contained in the lamps even if in small
quantities, which may be released into the environment.
Before proceeding with this operation, it is essential to strictly respect the following
instructions, in order to protect yourself and always be in safe conditions.
NOTE: also consider that the space in which you operate is always subject to
contamination.
For these reasons the replacement of the lamps is recommended to be carried out by
technical service and maintenance personnel.
Before replacing proceed as follows:
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7.4.1 UV LAMP
Turn off the BSC and disconnect it from the mains (see 5.2.3.2).
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PART 2:
INSTALLATION
AND
MAINTENANCE
WARNING!
All the operations described in this part of the manual should be performed only by
qualified technicians, properly trained authorized.
The user is not allowed in any of these operations.
BioAir declines all the responsibility for damage resulting from non-compliance with these provisions.
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8. INSTALLATION
WARNING!
All operations described in this Part 2 of the Manual should be performed by specialized and
authorised personnel, in compliance with the ruling laws concerning safety at work and
using all the necessary individual and collective protection.
Always consult the safety data sheets of products used for the operations described in this
manual.
WARNING!
Check the environment in which this cabinet can be installed (see paragraphs 2and 3.4).
THE MANUFACTURER DECLINES ALL CRIMINAL AND CIVIL LIABILITY FOR DEFECTS THAT ARE
MANIFESTED AND FOR DAMAGE TO PERSONS AND/OR THINGS DUE TO NON-AUTHORISED
INSTALLATIONS AND/OR WHICH ARE NOT COMPLIANT TO THE OPERATING INSTRUCTIONS
CONTAINED IN THIS MANUAL.
THE SAFETY OF ANY SYSTEM INCORPORATING AND/OR INTEGRATES THIS CABINET IS THE
RESPONSIBILITY OF THE ASSMBLER OF THE SYSTEM.
Pic. A1
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8.2 POSITIONING
WARNING!
Not suitable place may compromises the performance and the biological safety of the cabinet.
Read information in PART 1 (see the entire paragraph 2.1).
The overall dimensions of the cabinet mounted on the floor stand are shown in Pic. A1.
The cabinet is to be placed on the floor stand.
WARNING!
Not suitable support stand may compromise the stability of the cabinet.
Use of different support is strongly advised against and it is under total responsibility of the
customer.
PRECAUTIONS TO BE TAKEN:
Fit the cabinet on the support stand available in the BioAir optional accessories list.
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THE SAFETY OF THE BSC DEPENDS ON THE CORRECT INSTALLATION OF THE ACCESSORIES
ACCORDING TO WHAT IS INDICATED IN THIS MANUAL AND IT IS THE RESPONSIBILITY OF THE
ASSMBLER.
Fixed height.
Adjustable height.
WARNING!
Before assembling of the adjustable stand, check the height restrictions for this
cabinet model (see Part 1, 2.2.1).
Pic. A4
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Pic. A5
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NOTE 2: use pressure gauges with reading range consistent with the used pressures.
3. Close the test tap and wait for at least 1 minute.
TEST RESULT: no leakage must be found.
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The exhaust air can be left free in the environment, but in the required cases can be further
filtered and/or ducted outside.
The BSC shall not be connected directly to any other air-handling system.
NOTE: it may be provided exhaust the air to the atmosphere through an indirect connection,
and possibly to further purify the exhaust air, e.g. through an absorbent filter.
These modifications can be obtained through the installation of accessories designed by BioAir for
these needs. Below are the available accessories:
WARNING!
The requirement and feasibility of this type of modifications should be carefully
assessed by competent personnel in order not to compromise the performance of the
cabinet together with the safety of the operator, the environment and the product:
in the case of an external ducting, an adequate air intake must be guaranteed in
the room;
in the case of an additional filter, the increase in pressure drop on the exhaust
must be compensated by an adequate and balanced additional suction.
Read also information in PART 1 of this manual (see 2.5).
For this type of requirements contact BioAir, which, directly or through local distributors, will
provide assistance for the specific needs of the laboratories, proposing the appropriate
solutions.
NOTE: the installation of these accessories must be carried out after the cabinet has been
tested, as the cabinet performance must first be checked in normal conditions. Subsequently
the validation must be made with the new configuration, carrying out again the tests related
to the values of the airflows and to the alarm interventions.
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Pic. A12
This input allows you to silence the alarm during installation tests and routine
checks.
It is located on the right side of the upper part of the control panel (see Pic. 15 item
3, par. 5.1.7.4 and Pic. 36 item 4).
The mute takes place by inserting the tool to be requested from BioAir (see Pic.
A13). Pic. A13
WARNING!
Alarm mute is not allowed during the normal use of the cabinet.
Remove the tool immediately once the tests are finished.
Collect the packaging and disposed of it separately in compliance with any law and
regulation in force in the country where the machine is installed.
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WARNING!
Read information in PART 1 of this manual (see the entire paragraph 2.3).
Check the type of power supply required by the cabinet (see 3.1) and the
environmental conditions of use (see 3.4).
Verify that the supplied power cord is consistent with the assigned mains power
socket. The features of the cable are indicated in 2.3.1.
Use a dedicated power line with an electrical socket compliant with the specified in
2.3.2 and 8.5.1.
The supply cord (detachable) must be connected as indicated in 2.3.1.
Main fuses specifications are available in 2.3.3.
The tripping curve of the circuit breaker of the power line should be of type C.
If the power supply is supplied by UPS, the generated waveform must be pure
sinusoidal type.
WARNING!
Given the large number of models on the market, the operation of the cabinet can not be
guaranteed with all sine waveform generation systems.
Contact BioAir, either directly or through local distributors, to receive information on the
solution of this type of problem.
NOTE: the EFFICIENCY OF THE PROTECTIVE CABLE (EARTH) and DIELECTRIC STRENGTH are checked
in the factory on 100% of the cabinets, according to Annex F of the IEC 61010-1:2010/A1:2016 standard.
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The FLAMMABLE GAS line must be fitted to the inlet connection of the solenoid valve indicated in
Pic. A15 - item 2.
To electrically connect the solenoid valve, proceed as follows:
1. remove the technical compartment cover (Pic. A15 - pos. 6) by unscrewing the fixing
nuts (Pic. A15 - item 7);
2. fit the cable gland (Pic. A15 - item 5) in the provided hole (Pic. A14 - item 3);
3. connect the connector of the cable supplied (Pic. A15 - item 4) for the solenoid valve;
4. insert the free end of the cable supplied into the cable gland (Pic. A15 - item 5) and
connect it to the terminals indicated in the accessory instructions;
5. close the technical compartment and tighten the fixing nuts.
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The necessary checks are the following and must be performed in MODE 1 (see PART 1, 5.2.1), except
for the alarm thresholds, to be performed in MANUAL MODE (see 8.9.8):
HEPA filters integrity test (see 8.8).
Inflow air velocity test (see 8.9.1).
Downflow air (LAF) velocity test (see 8.9.2).
Containment at the front aperture (see 8.9.3).
Smoke pattern test (see 8.9.4).
Alarm thresholds test (see 8.9.7).
Working area air cleanliness test (see 8.9.6).
(NOT REQUIRED by the product standard, optional on prior request only)
NOTE 1: the test procedures should be carried out in accordance with the conditions defined
in the factory test report. The results of the laminar and exhaust air flow rate, should be
consistent to the ones of the factory test report (Quality Pass), where the performance data and
the type of instruments are indicated.
NOTE 2: in addition to the instruments required for the checks (see specific paragraphs), it is
advisable to have the following instruments
The test is based on the comparison between the particles detected upstream and downstream the
filter.
In order for the test to be valid, it is necessary that the concentration upstream of the filters is
sufficiently high to have a statistical confirmation. For this reason, particles having a particle size
within a given diameter must be produced by aerosol (see Tab. 9).
Proceed as follows:
1. Switch on the cabinet in MODE 1 (see PART 1, 5.2.1)
or in MANUAL mode (see 8.9.8) and wait a few
minutes for the operation of the cabinet to stabilize.
2. Depending on the instrument you chose to use (see
Tab. 9), connect the probe of the photometer or
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The aerosol generated is draw in by the fan and routed to the plenum upstream of the filters
where the required particle concentration has to be reached.
Tab. 9
UPSTREAM
PARTICLES DOWNSTREAM
SCANNING
DIAMETER
DISTANCE
DILUTION
VELOCITY
PARTICLES
PARTICLES
FACTOR
FILTER
CONCENTRATIO
FROM
N LOCAL
PENTRATION
(100 %)
Fotometer 10 ÷ 80 µg/l - ≤ 0.01%
< 1 µm
≥ 1,000,000 1:100 0.05 m/s 3 cm
Particle counter (MPPS) ≤ 0.05%
particles/ft3 see 2
NOTE 2: using a particle counter, to avoid a coincidental error or a damage of the optical
sensor you have to use a dilutor with a suitable dilution factor. The ratio indicated in Tab. 9 is
by way of example.
Check on the particle counter manual which is the maximum countable number of particles /
ft³.
4. Use the photometer or particle probe to scan the whole surface downstream the filters, at the
distance and at the velocity indicated in Tab. 9.
Acceptance criteria: see Tab. 9.
NOTE: any problems of airflow instability, often due to airflow sensor malfunction, can be identified by
proceeding with the check in MANUAL mode (see 8.9.8).
The procedures are described in 8.9.1, 8.9.2, 8.9.3 and 8.9.7.
Before starting the test check the following:
No presence of external air turbulences due, for example, to open windows, to the air-conditioning
of the room or due to passages of people.
Correct inserting of the working surface (see 5.1.6).
The UV lamp must be installed.
Cabinet lighting must be activated (at maximum power if adjustable).
Wait about 10 minutes before starting the check.
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Tab. 10 – Exhaust measurement grid and calculation factor for INFLOW (KI)
KI (see 2)
NOTE 2: the KI factor is obtained by dividing the area of the section in which the
measurement is performed for the cross-sectional area of the front opening (BARRIER AREA, see
PART 1, 3.6). Tab. 10 lists the KI values according to the sizes and exhaust sections provided for
the cabinet and for accessories with 200 mm diameter ducting.
In case of ducting with a different section, recalculate the KI factor.
1. Calculate the mean of the measurements carried out at the exhaust air outlet (VEXH).
2. Calculate the mean velocity of the frontal BARRIER (VINF) by the following formula:
VINF = VEXH x KI
Acceptance criteria: see DATASHEET (3.7, frontal barrier velocity).
3. Check the match with the data released by the manufacturer on the test report.
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DOWNFLOW air velocity is the mean velocity of the laminar air flow (LAF) in the working area
which protects the product on the work surfaces (VLAF).
in 1) on a grid of a virtual
horizontal plane, 150 mm below the
downflow filter (see Pic. A18),
according to AS 1807.1 (+A1).
The position of the measurements
must be divided into columns and
rows, both equally spaced.
Follow Tab. 11 to determine the
samples to carry out.
The external points of the grid
coincide with the perimeter of the
area in which the measurements are
made and which will delimit the SAFE
WORKING AREA (see 5.1.6.2).
The anemometer must be supported
by a appropriate support so that it can
be left in place without the operator's
arm interfering with the
measurement.
Pic. A18
Comply with the position of the anemometer in the various readings by following the arrows
shown in Pic. A18.
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Acceptance criteria:
the penetration of the test aerosol shall, on average, not exceed 0.01% more than
once every 10 s during the total period of test for each test position.
Acceptance criteria:
the test aerosol generated and released outside the work aperture shall not be
detected inside the work zone.
Acceptance criteria:
Airflow within the work area of the cabinet shall be downward, with no dead spots,
reflux, or escape from the cabinet.
Airflow along the entire perimeter of the work access opening shall be inward, with no
reflux out of the cabinet or smoke penetration over or onto the work surface.
Airflow within the work area of the cabinet shall be downward (no reflux), with no
escape to the outside of the cabinet at the sides and top of the window.
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NOTE 1: during manual operation mode the fluorescent lamps are lit.
2. Place the vane anemometer at a point corresponding to the calculated average
EXHAUST value (VEXH).
3. Place the hot wire anemometer at a point corresponding to the maximum value found
on the LAF reading grid.
4. Set the percentage of power to have the parameter airflows values measured.
5. Increase the power (%) until the alarm is shown (see Pic. A21).
6. Read the LAF value indicated by the hot wire anemometer (see 2).
The increase of LAF vs the mean value should not exceed 20%.
7. Place the hot wire anemometer at a point corresponding to the minimum value found
on the LAF reading grid.
8. Decrease the power (%) until the alarm is shown (see Pic. A21).
9. Read the INFLOW value indicated by the vane anemometer and multiply it by the KI
coefficient (see Tab. 10).
The decrease of the average value of INFLOW must not exceed 20% and must not be
less than 0.65 m/s.
10. Read the LAF value indicated by the hot wire anemometer.
The decrease of LAF vs the mean value should not exceed 20%.
NOTE 2: the value shown on the display always represents an average value, therefore
when checking the maximum and minimum LAF values, this cannot coincide with what is
indicated by the anemometer.
Normally the gap is equal to the difference between the average value and the value being
checked. Tab. 12 shows how to interpret the alarm value shown on the display.
Tab. 12 – Difference between actual LAF alarm value and that indicated on display
THEORICAL ALARM MINIMUM AND MAXIMUM DISPLAYED ALARM
THRESHOLDS VALUE OF THE LAF GRID VALUE
The results should match the values indicated in the factory test report (Quality Pass).
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NOTE: manual control is useful for checking the alarm activation at the set thresholds and
for checking ventilation parameters of the cabinet.
Changes made on this screen are not saved and do not change the calibration of the cabinet.
1. Switch on the cabinet in MODE 2 (see PART 1, 5.2.2).
Pic. A21
Press the key ENTER (SOCKET) to return to MODE 2.
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9. BIOLOGICAL DECONTAMINATION
The decontamination is a chemical and physical process for destroying all the kind of microorganism.
The decontamination of a BSC is MANDATORY before any service or maintenance operation, replacement
of the filters or any other operations that require access to parts potentially contaminated of the cabinet
and that could present a biological risk against the maintenance operator and external environment,
before moving or disposal of the cabinet and after any emergency.
The choice of the cabinet decontamination method must fall in the risk assessment of the process and of
the activities carried out in the laboratory and must therefore consider the pathogens that are used.
Formaldehyde, which has always been used as an effective contamination agent and proposed in the
guidelines set out in Annex J of the European Standard EN 12469:2000, has been recognized as a
carcinogen and at the issue date of this revision of the manual, several alternatives for decontamination
are under investigation.
An alternative decontamination procedure will be described below, which uses hydrogen peroxide (H2O2)
as decontamination agent.
The procedure has been validated through the use of chemical and biological indicators and it has been
demonstrated the ability to sterilize samples with a concentration of 106 spores of Bacillus
stearothermophilus.
You can use another method of decontamination at the discretion of the laboratory manager.
For this eventuality a function of the cabinet is available (see 9.2.4), which could facilitate the procedure.
In any case it is important that the decontamination procedure is considered into the risk assessment of
the process and activities performed in the laboratory and that a validation of the procedure is performed
using the right chemical and biological indicators (BI) that have a behaviour similar to the pathogenic
agents that are used in the BSC; in particular the BI's should be chosen in order to have a 6-log reduction
and should be positioned in the places where it is more difficult the diffusion of the decontamination agent
(for example in corners of working area, in air diffusion plenum, after exhaust filter).
This procedure must be validated by a method demonstrating compliance with the following requirements:
1) Decontamination effectiveness through the use of chemical and biological indicators correct and
positioned at critical points.
2) Safety of the operator and of the surrounding environment which should therefore not be
contaminated with dangerous substances.
3) Compatibility of the used agent with the mechanical and electrical components of the cabinet.
For the procedure with H2O2, BioAir has considered all the aspects listed above in the definition of the
following decontamination cycle.
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The solution of hydrogen peroxide and silver is nebulised into particles smaller than 5 μm. In
technical jargon the micronebulization (dry mist), that is the process through which a liquid is
reduced into tiny particles.
The emitted particles are airborne and, remaining suspended, reach all free surfaces.
The cabinet is wrapped in a transparent plastic cover and sealed in order to guarantee the
effectiveness of the process and not to disperse the particles generated by the nebulisation of
H2O2 into the environment.
9.1.2.1 MICRONEBULIZER
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Hydrogen peroxide:
(TLV = 1 ppm)
Silver sulfate:
(maximum allowed limit: 0.01
mg/m3)
Brand: STERIS
Product: VAPORIZED VH202 Process Indicator
Class: 1
Conformity: ISO 11140-1:2014
Single use
Product subject to expiry Pic. A26
Position the indicators (Pic. A26) in the points
shown in Pic. A27
9.1.2.6 VARIE
Special sealing tape
Trust of “ATTENTION DECONTAMINATION IN PROGRESS” (Italian/English)
Portable instrument for H2O2 detection with probe
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WARNING!
Check that the environment in which this decontamination is carried out has a minimum
volume such that when the cabinet is opened, at the cycle end, the concentration of nebulised
H2O2 inside can be diluted in the environment at the allowed levels (see also 9.1.2.4 and the
related ).
To calculate the necessary volume, consult the table Tab. 13.
Tab. 13
TLV ADMITTED INSIDE CABINET AT CYCLE END [ppm] 5
TLV ADMITTED IN THE ENVIRONMENT [ppm]
1 0.7 0.5 0.3
(See the legislation of your Country)
MINIMUM REQUIRED ROOM VOLUME [m3] 20 30 40 70
fitting safety goggles protective gloves that provides clothing that provides
comprehensive protection comprehensive protection to
the skin
and all the necessary protections when working with corrosive or dangerous substances.
Use a portable instrument for detecting H2O2 during whole decontamination procedure to
check its concentration.
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11. Coat the cabinet with the plastic bag (Pic. A28 - item 2) supplied in the decontamination kit
(see 9.1.2.2) by trimming it in such a way as to eliminate the excess parts
(This operation is used to avoid the formation of pockets in which decontaminant residues
may remain in high concentrations).
12. Make the necessary holes to make the following cables come out:
exit hole of the cabinet power cord (Pic. A28 - item 3); and
exit holes of the control and supply cables of the nebulizer (Pic. A28 - item 4).
13. Carefully seal all the engraved parts for the arrangement of the bag and the cable passage
holes with adhesive tape.
14. Carefully seal the junction of the plastic bag with the cabinet along the entire lower perimeter
with adhesive tape (Pic. A28- item 6).
15. Check carefully that there are no damages (even small scratches) to the containment bag
and in case seal them with adhesive tape.
16. Apply the "CAUTION DECONTAMINATION IN PROGRESS" warning on the containment bag
and on the outside of the access door to the room.
17. Be sure that there is no risk that an HVAC plant will recirculate air into an adjacent room with
presence of personnel.
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NOTE 2: the product of the values in Pic. A30 - items 1 and 2 must correspond to the
quantity of decontaminant indicated in Tab. 14.
For easiness it is advisable to leave the value of item 1 set to 1 ml / m3.
MODE 1
related note ).
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WARNING!
The doses and times indicated in Tab. 14 for the decontamination cycle with this method
refer only to the volume created by the containment bag.
If for some reason it is necessary to act on larger volumes, the times and the doses
must be recalculated through a new validation of the necessary procedure.
5. Press the PROGRAM MODE key on the external keyboard of the nebulizer again (Pic. A29 -
item 4) to confirm the program.
6. Make sure that there is no personnel in the room affected by this decontamination.
WARNING!
During the whole decontamination phase, equip yourself with adequate portable
instrumentation to check the level of H2O2 in the environment remains within allowed
NOTE 3: if this filling lasts for longer than 150 seconds (therefore the pump remains
active for longer than 150 seconds) it is assumed the bottle is empty (no functional block is
provided for).
The display will show this condition with the message: ALM BOTTLE.
To reset the signal it is necessary to replace the bottle and then restart a cycle of
decontamination. The bottle release method is described in 9.2.3.1.
Once the decontaminant load has been
completed, the display shows the message in
Pic. A32 with the start of H2O2 dispensing and
the set time decrease.
Once the program minutes/seconds have
elapsed, the START/STOP LED turns off while the Pic. A32
display returns to display the message in Pic.
A30.
9. Leave the cabinet switched on and wait for 60 minutes.
10. Start the second decontamination cycle by pressing the STAR/STOP key.
11. Leave the room.
12. After the second cycle, wait 15 minutes and then switch off the cabinet.
In this condition the dispensing phase of decontamination cycle is ended.
NOTE 4: in case of interruption of mains electrical supply, when power is reinstated the
unit goes back to the state (idle-on or stand-by) that it was in at the time of power failure.
If a decontamination cycle is performed during the interruption, it is aborted.
All the data set remain stored. The decontamination is to be repeated.
13. Leave the cabinet sealed and wait 12 hours to allow the H2O2 concentration to be reduced.
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WARNING!
Even if the cabinet is sealed and the recorded level of H2O2 during validation test is lower
than allowed limit, consider always that something could go wrong and so use all the
necessary precautions before to enter into the room.
Before proceeding with this operation after decontamination cycle, use the necessary
precautions: it is recommended the use of PPE (mask, gloves, glasses, etc.) and verify
by means of suitable equipment that the H2O2 concentration in the room be lower than
NOTE 2: in case the concentration is higher, seal the hole made and repeat the check
after 4 hours.
5. Once the concentration level is stabled within the limits, remove the plastic bag, the hose and
the chemical indicators.
In this stage still wear protective devices.
6. Run the cabinet in MODE 1 for at least 15 minutes.
7. Check that the concentration level of H2O2 in the cabinet and in the room is less than the
The cabinet is now ready for the necessary operations (use and service or maintenance).
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WARNING!
The following instructions explain only how to use the function for a possible alternative
decontamination method that must be validated by the user.
9.2.4.1 PROCEDURE
1. Turn on the cabinet in MODE 2 (see
PART 1, 5.2.2).
2. Close the front window.
8. Elapsed this time press the keys e and hold them for Pic. A37
30-40 seconds.
The service socket is turned off and the fan starts. Display will
show the message FUMIGATION RECIRCULATION (Pic. A37).
9. Release the keys.
The fan stops. Display shows FUMIGATION IN PROGRESS (Pic.
A35).
10. Leave the cabinet in this status for the time established for the Pic. A38
contact phase.
11. Past this time restart the cabinet.
PURGE mode is activated: the fan starts (FUMIGATION PURGE
Pic. A38) at reduced velocity and the front window will be
partially opened (few centimetres).
12. Remove the switch key and leave the cabinet running in
FUMIGATION PURGE for the time established for the purge
Pic. A39
phase.
In case of blackout, when the power is reactivated the display
will show the message of Pic. A39.
13. After PURGE phase turn off the cabinet and remove the used
equipment.
Pic. A40
NOTE 3: the function is set with predefined values of the
times and characteristics of the cycle phases (see Pic. A40).
To modify these parameters, request instructions from BioAir.
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WARNING!
Biological hazard
The internal parts of the BSC are to be considered contaminated.
Decontaminate the BSC (see 9.1) before opening the access panels to the filters and fan
motor.
Unplug the power cord from the mains outlet before accessing the components.
Do not perform any operations before obtaining the necessary instructions from BioAir.
Tab. 15
DESCRIPTION HOW OFTEN DO
(months)
A Filters integrity 6
DOWNFLOW and INFLOW air velocity 6
Containment at the front aperture 6
Displaying ventilation parameters 6
Alarms 6
Smoke pattern test 6
B Defects, cracks or other damage of internal and external surfaces 12
Extraction duct system (if present) 12
Anti-blow back valve (if present) 12
Protective conductor efficiency [EN 61010-1, annex F] 24
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Contact BioAir to request the training and technical information necessary for such an intervention.
WARNING!
HEPA filters should be decontaminated in situ prior to disposal.
The requirement for, and the method of, decontamination must be by risk
assessment (see also par. 9).
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WARNING!
Biological hazard.
Some components are located in contaminated area.
Electric shock hazard.
Some components remain hazardous live despite the cabinet being switched off via the key
switch.
Contact BioAir for the training necessary for interventions inside the cabinet.
In the event of an emergency being necessary, carry out the following actions:
decontaminate the cabinet before accessing internal parts and components;
disconnect the cabinet from the mains by means of the plug on the power
cable.
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80.008.122 Motorblower 1 1 1 1
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The complete list of spare parts will be made available to service personnel
who have received adequate training from BioAir.
The wiring diagram will be provided to the service staff adequately trained by
BioAir.
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