CY401 Operators Manual
CY401 Operators Manual
Class II Type
Biological Safety Cabinet for Instrument Handling
MODELS:
CY401/CY401-INT/CY401-J
P. O. Drawer E / 161 Gatehouse Road / Sanford, Maine 04073 / USA
800-992-2537 / 207-324-8773 / Fax: 207-324-3869 / bakerco@bakerco.com / bakerco.com
Welcome to Baker
Thank you for choosing to join the growing number of people who are achieving excellence in science and clinical
care through clean air, containment, and incubation solutions from Baker. As a fixture in laboratories and clinical
settings around the world, Baker takes special pride in helping people just like you to create optimal
environments for their work, while providing a safe and comfortable user experience.
At Baker, nothing is more important to us than the trust you place in our solutions to help you achieve your
goals. Whether you are involved with basic scientific research, drug discovery, or patient care, Baker has a
proven record of delivering high-performing equipment through an uncompromising commitment to safety,
testing, quality, and craftsmanship. Additionally, as a Maine-based family owned business in operation for more
than 60 years, you can rest assured that Baker will be there for you throughout the life cycle of your new
equipment.
Baker is a pioneer in the field of biological safety, and our reputation is built on taking no shortcuts and making
no compromises when it comes to user safety. We are the only manufacturer to routinely subject our own
equipment to extensive microbiological aerosol testing in the most challenging conditions – above and beyond
what the average user would ever encounter. However, the adequacy of any equipment for user safety in a
specific application should always be evaluated. This risk assessment should be performed by an industrial
hygienist, safety officer, or other qualified person representing the purchasing organization. Remember that
you, the owner and user, are ultimately responsible and that you use this equipment at your own risk.
I recommend that you keep a copy of this manual, along with the factory test report (if applicable), near your
new equipment for convenient reference by operators and qualified maintenance personnel. If you have any
questions about the use or care of your Baker equipment, please do not hesitate to contact our Technical Service
Department for assistance at (800) 992-2537 (+1 207 324-8773 outside the United States) or
techsupport@bakerco.com.
Sincerely,
David Eagleson
President
The Baker Company, Inc.
161 Gatehouse Road / Sanford, Maine 04073 / USA
800-992-2537 / 207-324-8773 / Fax: 207-324-3869 / bakerco@bakerco.com / bakerco.com
Table of Contents
In operation, CY401 delivers HEPA filtered, unidirectional down flow air to the work area. Most of the HEPA
filtered air passes through an air diffuser; flows down into the work area and enters the front work surface
perforation. Some of the HEPA filtered air is diverted down behind the viewscreen creating a downward high
velocity momentum air curtain along the rear surface of the viewscreen. Concurrently intake room air is pulled
inward through the front access opening at a minimum of 100 feet per minute (FPM) (0.51 meters per second
(m/s)) where it merges with the down flow air entering the front work surface perforation and is pulled into the
drain pan below. All of the air is drawn up the cabinet exterior walls under negative pressure and enters the
motor blower inlet where it is then discharged into an internal plenum. The air from within that internal plenum
has two possible flow paths. Approximately 70% of the air is recirculated back to the work area through the
supply HEPA filter and diffuser while the remaining 30% is discharged through the exhaust HEPA filter exiting
the top of the cabinet. (See Figure 1)
Cabinet Design
Figure 2 below shows the standard construction and components of the cabinet.
Duplex outlet
One of each side wall 3 inch dia cable port
One of each side wall
Removable Front Grille
With padded armrest Roll in/out
work surface
Drain Valve
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CY401 SterilGARD® e3 Operators Manual
Regulatory Compliance
Standards
This Baker product has been designed, manufactured and tested to comply with the following regulatory
standards where applicable. Unless stated otherwise, the most recent edition of these standards has been
applied.
Electromagnetic Compatibility:
Electrical Equipment For Measurement, Control and Laboratory Use, EMC Requirements
INTERNATIONAL: Electro Magnetic Compatibility Directive 2004/108/EC; EN61326-1
Biological Safety:
US : Biosafety Cabinetry Certification; NSF/ANSI 49
INTERNATIONAL: Biotechnology – Performance criteria for microbiological safety cabinets; EN 12469
Cautionary Notes
Hazards may still exist, especially if the cabinet is not installed, operated and maintained according to the
instructions in this manual and the service manual.
This cabinet may be affected by high levels of electromagnetic radiation from other electronic devices that are
being used in close proximity or connected to the same facility power system.
This cabinet may cause radio interference or affect the operation of other equipment in close proximity.
Mitigation measures such as relocation, re-orientation, or shielding may be required.
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Standard Features
Alarms
The cabinet has audible and visual alarms to alert the operator of some unsafe conditions as defined in this
manual. The standard annunciated alarms, in order of priority, are power/processor fault alarm, viewscreen
alarm, and double viewscreen position sensor fault alarm. See the Alarm Conditions section in this manual for
detailed descriptions of the alarms.
Armrest
The armrest pad is made from EPDM sponge material which is resistant to most chemicals as well as UV
exposure. The pad is held in place with an adhesive and can be easily removed for cleaning. It can also be
autoclaved.
Cable Ports
The cabinet has a 3 inch diameter cable port located in the right and left side wall. They provide a safe means
of introducing power cables, vacuum aspiration tubing or other similar items into the work area. It is designed
with flexible rubber allowing multiple cables and/or tubing up to 1.50 inch [38.1 mm] in diameter. The cable
port passageway is under negative pressure and has been microbiologically tested and validated to prevent the
escape of aerosols from the cabinet work area and the introduction of contaminants into the cabinet work area.
See the Cable Port Usage section of this manual for more information.
Cabinet Controls
The operator controls and indicators are arranged in a single, easily cleanable membrane switch assembly on
the front of the cabinet. It has pushbuttons for cabinet blower, work area lighting, outlets, and alarm mute. See
the Controls section in this manual for more detail.
Drain Pan
The drain pan is constructed of stainless steel with smooth corners to facilitate cleaning and disinfection.
Drainage is provided by a stainless-steel ball valve.
Filters
CAUTION
Filter media is very delicate and should never be touched.
Only qualified technicians should replace HEPA filters.
The High Efficiency Particulate Air (HEPA) filters consist of a continuous sheet of glass fibers pleated and
mounted in a rigid frame. The supply and exhaust filters inside the cabinet are scan-tested HEPA filters. They
are 99.995% (H14) effective on removal of the most penetrating particle size (mpps) (0.3 micron). Each filter is
leak checked after installation in the cabinet and prior to shipment. HEPA filters are not intended to filter gasses
or vapors. Since this cabinet is partially recirculating, there could be gaseous buildup to the point of equilibrium
if gasses or vapors are used. Misuse of chemicals, Bunsen burners, or a heavy dust load will shorten the filter’s
life.
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Lighting
The work area is illuminated to provide a typical average light intensity of 100 foot-candles [1,076 lux] at the
work surface. This cabinet features LED lighting without the use of ballasts.
Motor/Blower
The motor and blower are built as a single assembly and balanced to minimize vibration. The motor control
automatically compensates for an increase in pressure drop across the filters without reducing the total airflow
rate by more than 10%. The airflow capacity of the cabinet is measured by the ability to provide a nearly constant
volume of air as the filter resistance to airflow increases.
Outlets
This cabinet has one duplex outlet in the right sidewall and one in the left sidewall for powering instruments
inside the work area. The total rating of all outlets combined is 5 Amps for 115VAC cabinets and 3 Amps for
230VAC cabinets. Only in the 115V cabinets is the outlet protected by a Ground Fault Circuit Interrupter (GFCI).
Pressure Monitor
The cabinet has an analog differential pressure gauge which displays the cabinet negative operating pressure.
ReadySAFE™ Mode
The ReadySAFE™ Mode is a feature that reduces the total airflow and energy consumption when the cabinet is
not being used. Operation of the cabinet in ReadySAFE™ Mode maintains personnel, product and environmental
protection. The ReadySAFE™ Mode is activated by aligning the view screen with the green arrows on either side
of the guides.
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Stand
The telescoping stand has adjustable legs and leg levelers for work surface elevations with minimum of 27 7/8”
[708 mm] and maximum of 39 ½” [1,003 mm].
Timers
The cabinet has programmable off delay timers to control the operation of the work area lights and accessory
outlets. The timers can be programmed in 15-minute or 1-hour increments. See the Operation section in this
manual for more detail.
Towel Guards
The towel guards are located under the work surface at the bottom rear and sides of the return-air plenums.
Acting as a protective screen, integral to the interior walls, they help prevent wipes and other materials from
being drawn into the blower system.
View screen
The cabinet viewscreen is constructed of UV resistant safety glass. It is designed to move vertically to allow
access to the work area and it is counterbalanced for ease of movement. The proper work access opening is
clearly marked with arrows on each side of the viewscreen and the position of the viewscreen is monitored by
an optical sensor activating the viewscreen alarm when not properly positioned.
Work Surface
The work surface consists of a roll in/out design and is constructed of stainless steel work surface supported by
PVC board. The roll in/out function supports the installation of heavy instruments without having to lift these
manually inside the cabinet. This surface is finished to reduce light reflection. The work surface and work surface
supports are removable allowing access to the drain pan.
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Optional Features
FlexAIR™ Canopy Exhaust Connection (CEC)
The FlexAIR™ canopy exhaust connection with integrated alarm provides the cabinet with a safe exhaust
connection to building exhaust systems as required by NSF/ANSI Standard 49.
Air-Tight Damper
An Air-Tight Damper is available for the FlexAIR™ canopy exhaust connection if isolation of the cabinet is
required during decontamination or maintenance.
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CY401 SterilGARD® e3 Operators Manual
CAUTIONS
If cabinet is used for work with volatile chemicals and radionuclides adjunct to
microbiological studies it must be exhausted outdoors through a properly functioning
canopy exhaust system.
If the operator does not operate the cabinet correctly, it may not provide an adequate
protective barrier. To ensure personnel, product and environmental protection the cabinet
must be operated per the manufacturer’s instructions.
Baker biosafety cabinets are designed for continuous operation. It is recommended that the blower be left on
at all times to provide containment and keep the interior work area clean and free of particulates.
Reference sources are National Sanitation Foundation Standard 49 Annex E, The Biosafety in Microbiological
and Biomedical Laboratories (BMBL), 5th edition published by the U.S. Department of Health & Human Services
as HHS Publication No. (CDC) 21-1112 and United States Pharmacopeia chapters <795>, <797>, and <800> as an
advisory document for safe work practices.
The facility industrial hygienist, pharmacist or biosafety officer shall ensure that:
The biosafety cabinet is appropriate for all operations and procedures to be performed.
All operators are thoroughly trained and competent regarding cabinet operation and all procedures they are
required to perform.
The cabinet operation, procedures, and operators are monitored at regular intervals to ensure that safety is
maintained.
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Cabinet Controls
The operator controls and indicators are arranged in a single, easily cleaned membrane switch assembly on the
front of the cabinet. There are pushbuttons for the fluorescent light, outlet, blower and alarm mute. [Reference
Figure 4]
Work Area Light On/Off – This pushbutton controls operation of the work area light. A blue indicator
light located below the pushbutton will illuminate when it is on.
Outlet Power On/Off – This pushbutton controls the power to the outlet in the work area. A blue
indicator light located below the pushbutton will illuminate when it is on.
Blower On/Off – This pushbutton controls the operation of the cabinet blower. A green indicator light
located below the pushbutton will illuminate when it is on.
Alarm Mute (Alarm Reset) – This push button mutes any audible alarm. A red indicator light located
below the push button will flash when an alarm condition exists.
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Cabinet Operation
Work Area Lighting
The LED lighting is designed to provide an average intensity of greater than 100 foot candles [1,076 lux] at the
cabinet work surface. The cabinet blower must be on for the lighting to operate. The lighting will not operate
when the viewscreen is closed.
Outlet
The circuit powering the outlet is protected by a self-resetting circuit breaker which allows a total of 5 Amps on
the outlet. This helps protect the primary cabinet controls from inadvertent overloads of the cabinet outlet. The
cabinet is equipped with an outlet in the right and left side wall of the work area.
For 115V AC/60Hz cabinets the outlet is protected by a Ground Fault Circuit Interrupter (GFCI) in the right side
wall. If the GFCI is tripped by the presence of an unsafe condition a red indicator on the GFCI will be on and the
reset button on the front of the GFCI will be extended. Once the fault condition is corrected press the [RESET]
button to reconnect power to the outlets. There is also a [TEST] button on the front of the device. The
manufacturer recommends that the GFCI device be tested monthly to assure safe operation.
Blower
The motor and blower are built as a single assembly and balanced to minimize vibration.
The blower motor control is designed to automatically compensate for an increase in pressure drop across the
filters without reducing total airflow rate by more than 10%. The airflow capacity of the cabinet is measured by
the ability to provide a nearly constant volume of air as the filter resistance to airflow increases. The motor
control also compensates for normal variations in power to the cabinet.
The blower must be turned on for the work area lighting to operate.
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CY401 SterilGARD® e3 Operators Manual
NOTE - The device to be programmed should be in the off condition before programming.
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CY401 SterilGARD® e3 Operators Manual
Alarm Conditions
The cabinet has audible and visual alarms to alert the operator of some unsafe conditions as defined in this
manual. The standard annunciated alarms, in order of priority, are power/processor fault alarm, front
viewscreen and side access window alarm, and double viewscreen position sensor fault alarm.
reset pushbutton will mute the audible alarm for 5 minutes. The visual alarm will continue until the unsafe
condition is corrected. If the unsafe condition is not corrected, the audible alarm will return.
Start-up Procedure
The operator should have read and understood the controls and operation section of this manual prior to
performing this procedure.
1. If the cabinet has not been left running continuously, turn on the blower. An indicator light located
below the pushbutton will illuminate when it is on. Listen for the sound of the cabinet blower running.
3. With the viewscreen placed at the safe design opening indicated by marker arrows on both the right
and left viewscreen guide, check the reading on the pressure gauge; the displayed value should remain
consistent with the recorded value in the most recent certification report. A significant change in
pressure should be cause for investigation. This device is not intended to be used for airflow set-point
verification.
4. Turn on the work area lighting. The indicator light below the push button will illuminate along with the
interior work area. The lighting will not operate unless the cabinet blower is on.
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CY401 SterilGARD® e3 Operators Manual
6. Align the viewscreen bottom edge with the green arrows indicating the ReadySafe mode .This action
engages the ReadySafe Mode, which is indicated by the work area light turning off and a reduction in
cabinet blower speed. This will also be indicated by a lower pressure reading displayed on the pressure
gauge.
7. Raise the viewscreen 2 inches (51 mm) from its fully closed position.
8. At this viewscreen location an audible and visual alarm should activate indicating that the viewscreen in
not at its safe design opening. Press the mute pushbutton to verify its operation.
9. Raise the viewscreen to the safe design opening indicated by the red marker arrows on both the right
and left viewscreen guide.
10. Wipe down all interior surfaces of the cabinet work area with an appropriate surface disinfectant.
IMPORTANT
Some disinfectants, such as bleach or iodine, may corrode or stain the steel surfaces. Good
practice is to thoroughly clean the surface afterward with a detergent, rinse with sterile
water and wipe completely dry to prevent corrosion.
11. Place all materials to be used for the procedure on the solid section of the work surface inside the
cabinet. This may require raising the viewscreen. Blocking the front and rear perforated grilles must be
avoided. Disinfect the exterior of these materials prior to placing them on the work surface. Everything
required, and only what is required, should be placed in the cabinet before beginning work so that
nothing passes in or out through the air barrier until the procedure is completed. Implements should be
arranged in the cabinet’s work area in logical order so that clean and dirty materials are segregated,
preferably on opposite sides of the work area. If wipes or absorbent towels are used on the work surface,
be sure to keep them away from the grilles.
12. After instrument(s) is in place inside the cabinet, adjust the sliding viewscreen to the safe design opening.
An alarm will signal if it is not at the proper opening. This position is important to maintain proper cabinet
airflow.
13. Before using, allow a minimum of three minutes with the cabinet operating in its normal safe
configuration to purge any contaminants or suspended particulates.
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This section contains some suggested basic work practices that should be observed when using a biosafety
cabinet. It is not intended to be a comprehensive list for all applications. A good reference source is The Biosafety
in Microbiological and Biomedical Laboratories (BMBL) 5th edition published by the U.S. Department of Health
& Human Services as HHS Publication No. (CDC) 21-1112 advisory document for safe work practices.
The operator’s hands and arms should be washed thoroughly with germicidal soap both before and after
working in the cabinet. It is recommended that long-sleeved gowns or lab coats with tight-fitting cuffs and sterile
gloves are worn, to minimize the shedding of skin, or related contaminants, into the work area and to protect
hands, arms and clothing from contamination.
Avoid using floor-type pipette discard canisters. It is important that used pipettes be discarded into a tray or
other suitable container inside the cabinet. This reduces unnecessary movement in and out of the work area.
Because of the restricted access, pipetting within the cabinet will require the use of pipetting aids.
All work should be performed using the recessed area of the solid work surface. Work should be performed
using slow movements, and the number of movements should be limited as much as possible. All materials
required should be placed in the cabinet prior to starting a procedure to reduce the need for the operator to
move arms in and out of the cabinet through the air barrier.
Room airflow can significantly affect cabinet operation. Opening and closing doors in the laboratory can cause
air disturbances which might interfere with cabinet airflow. This kind of activity should be kept to a minimum
while the cabinet is in use. Personnel should avoid walking by the front of the cabinet while it is in use. The
location of facility air diffusers and personal fans can have an adverse effect on cabinet safety.
When a procedure has been completed, all equipment that has been in contact with the research agent should
be enclosed and the entire work surface decontaminated. Trays of discarded pipettes, glassware, etc. should be
covered. The cabinet should then be allowed to run for a minimum of three minutes, with no activity, so that
the airborne contaminants will be purged from the work area. Once this has been done remove all equipment
from the cabinet.
WARNING
Never use the cabinet to store supplies or laboratory equipment not specifically designated
for this cabinet
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CY401 SterilGARD® e3 Operators Manual
After removing all materials, culture apparatus, etc. from the cabinet, decontamination of the interior surfaces
should be repeated. Check the work area carefully for spilled or splashed nutrient that might support bacterial
growth.
It is recommended that the cabinet be left running continuously to ensure containment and cleanliness. The
viewscreen alarm is not activated when the window is in the fully closed position.
Conduct a risk assessment prior to removing or introducing cables or tubing through the
cable port passageway. Cabinet decontamination may be required.
The cable port provides a safe means of introducing power, cables, vacuum aspiration tubing, etc. into the
cabinet work area. These items should be installed prior to initial cabinet use. Removing or introducing items
through the cable port after cabinet use shall require a risk assessment as the cable port passageway may be
contaminated. Caution labels are provided on the interior and exterior of the cabinet to remind the operator
of potential hazards.
Reacting to Spills
Even when good work practices are used, occasional spills may occur. All spills should be dealt with immediately
to prevent contamination and to avoid any damage to the stainless steel surfaces. It is recommended that the
operator, in coordination with the facility safety professional, have a written plan available in case of an
accidental exposure or spill. The safety plan should include all of the emergency procedures to be followed in
the event of an accident. All employees who use the cabinet should be familiar with the safety plan.
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Cleaning Spills
CAUTION
Spills on the work surface should be first cleaned and disinfected. Spills that fall through the perforated grilles
in the work surface should be cleaned up and all waste put in an appropriate disposal container inside the work
area. The remainder can be removed through the drain valve in the drain pan after proper decontamination of
the work area. To clean the drain pan under the work surface, lift the work surface, completely surface
decontaminate the work surface including the underside and work surface supports, then remove all
decontaminated items from the work area. Removing these parts provides unobstructed access to the drain pan
for easy cleaning. The drain valve must be closed when cleaning of the drain pan is completed. Before
reinstalling the work surface and supports, disinfect all surfaces.
After cleaning and disinfection, all surfaces should be rinsed with sterile water and wiped
completely dry.
Simple Cleaning
IMPORTANT
Do not use steel wool or steel pads when cleaning stainless steel.
Dirt deposits on stainless steel (dust, dirt and finger marks) can usually be removed using warm water, with or
without detergent. If this does not remove the deposits, a mild, non-abrasive household cleaner can be used
with warm water and bristle brushes, sponges or clean cloths.
Iron rust discoloration can be treated by rubbing the surface with a solution of 15% to 20% by volume of nitric
acid and water and letting it stand for one to two minutes to loosen the rust. The proper safety equipment
should always be used when handling acids.
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CY401 SterilGARD® e3 Operators Manual
Disinfection
The purpose of disinfection is to destroy any organisms that could pose a potential hazard to humans or
compromise the integrity of the experiment. To ensure an organism is killed it is important to use a disinfectant
in the proper concentration that is known to be effective for the specific organism. Standard disinfectants
include: Iodophor-Detergent, Ethanol, Phenol and Alcohol. Hypochlorite (chlorine bleach) can also be used in
dilute concentrations. Caution should be used, as Hypochlorite can cause pitting and/or cracking of stainless
steel if it is either too concentrated or not completely removed from the surface in a timely manner. Allow an
appropriate time to lapse for deactivation purposes (ref. BMBL 5th Edition) depending on the type of disinfection
agent used. Follow up with a sterile water rinse and wipe completely dry to protect the stainless steel surface.
Disinfect the work area and work surface before and after every procedure.
Place all items that may have come in contact with the agent(s), such as used pipettes, in a plastic bag or other
suitable container.
For additional information on cleaning and disinfecting stainless steel, please refer to: “Decontamination,
Sterilization, Disinfection, and Antisepsis,” Vesley, Donald and Lauer, James L., Laboratory Safety Principles and
Practices, 2nd edition, 1995, Fleming, D.O., Richardson, J.H., Tulis, J.J. and Vesley, D., editors, ASM Press,
Washington, D.C., pp. 219-237; and Biosafety Reference Manual, 2nd edition, 1995, Heinsohn, P.A., Jacobs, R.R.
and Concoby, B.A., editors, AIHA Publications, pp.101-110.
Space Decontamination
CAUTION
All decontamination procedures should be reviewed and approved by the facility biosafety
officer. Only individuals experienced and qualified in Hydrogen Peroxide vapor
decontamination should be allowed to perform this procedure.
This cabinet must be space decontaminated when access to potentially contaminated areas are required for
maintenance, service or repairs. Hydrogen Peroxide vapot is the only decontamination agent allowed for this
system. Formaldehyde, Chlorine Dioxide (CLO2) or any other gaseous decontamination agents are not
permitted.
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CY401 SterilGARD® e3 Operators Manual
We recommend that the manual be kept near the cabinet for ready reference.
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