Operator’s Manual
TM
AER DEFENSE
S M O K E E V A C U A T O R
TM
CM
ELECTROSURGERY
N ED
O
LIMITED WARRANTY
For a period of two years following the date of delivery,
CONMED Corporation warrants the CONMED
AER DEFENSE™ Smoke Evacuator against any defects in
material or workmanship and will repair or replace (at
CONMED’s option) the same without charge, provided
that routine maintenance as specified in this manual has
been performed using replacement parts approved by
CONMED. This warranty is void if the product is used in
a manner or for purposes other than intended.
TM
© 2016 CONMED Corporation
525 French Road
Utica, NY 13502-5994 USA
Patent Pending
For Technical Service or Return Authorization Phone:
303-699-7600 / 1-800-552-0138 Extension 5274
Fax 303-699-1628
For Customer Service or to order parts phone:
1-800-448-6506 / 315-797-8375 / Fax 315-735-6235
or contact your CONMED Representative.
EC REP
European Authorized Representative
MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
The revision level of this manual is specified by the
highest revision letter found on either the inside front cover
or enclosed errata pages (if any).
Manual Number: 60-8081-ENG Rev. G
Unit Serial Number_________________________________
AER DEFENSE
TM
Table of Contents
& List of Illustrations
Section Title Page
1.0 General Information ......................................................................... 1-1
1.1 Introduction .........................................................................................................1-1
1.2 Inspection .............................................................................................................1-1
1.3 Cautions and Warnings .........................................................................................1-2
1.4 Compatibility .......................................................................................................1-4
1.4.1 Accessory Diagram ...............................................................................................1-5
1.5 Explanation of Symbols ........................................................................................1-5
1.5.1 Control Panel ........................................................................................................1-5
1.5.2 Rear Panel ............................................................................................................1-6
2.0 Operation .......................................................................................... 2-1
2.1 System Controls ...................................................................................................2-1
2.1.1 Control Panel ........................................................................................................2-2
2.1.2 Rear Panel ............................................................................................................2-3
2.2 FilterOne™ Installation .........................................................................................2-4
2.3 Set-up and Operation ...........................................................................................2-5
2.3.1 AER DEFENSE™ ESU Activation Connection Set-Up .......................................2-7
2.4 Specifications ........................................................................................................2-9
3.0 Maintenance ...................................................................................... 3-1
3.1 General Maintenance Information ........................................................................3-1
3.2 Cleaning ...............................................................................................................3-1
3.3 Periodic Inspection ...............................................................................................3-1
3.4 Troubleshooting the AER DEFENSE™ ...............................................................3-1
4.0 Service .............................................................................................. 4-1
4.1 Equipment Return ................................................................................................4-1
4.2 Service/Ordering Parts ..........................................................................................4-1
4.3 Environmental Protection .....................................................................................4-1
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AER DEFENSE
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General Information
Section 1.0
CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN.
1.1 Introduction
Indications for use: The CONMED AER
DEFENSE™ Smoke Evacuator is designed to
remove smoke, aerosols and mitigate odors
produced by surgical smoke during electrosurgical
procedures.
The CONMED AER DEFENSE™ Smoke
Evacuator has been designed with a high suction,
high flow rate, thru flow vacuum motor. Its quiet
motor is used to draw the surgical smoke from
the surgical site, through the vacuum tubing and
into the CONMED AER DEFENSE™ Smoke
Evacuator’s FilterOne™ where the surgical smoke
is processed by a series of filtration stages. A
single disposable filter is used to simplify the
installation and removal during filter changes.
The FilterOne™ is completely enclosed to
protect the health care personnel from potential
contamination during filter changes. Each
FilterOne™ contains three integral filter stages to
capture the smoke plume.
The first stage of filtration is a pre-filter whose
function is to trap and remove gross particulates
and casual fluid.
The second stage of filtration uses the highest
grade of virgin grade activated carbon for the
removal and adsorption of odors and toxic gases
produced by electrosurgical tissue effects. These
harmful gases may constitute a health hazard
to health care professionals who are subjected
to prolonged exposure. The activated carbon
used in the FilterOne™ preferentially removes
toxic organic gases rather than water vapor and
provides optimal odor removal.
Each ULPA grade media filter is certified
before use.
The electronic controls on the front panel of the
CONMED AER DEFENSE™ Smoke Evacuator
have been designed to be “user friendly” and
facilitate unit set-up and operation. Please refer to
Section 2.0 for operating instructions.
1.2 Inspection
The CONMED AER DEFENSE™ Smoke
Evacuator has been thoroughly tested and
inspected before shipment from the factory. Please
check the unit before using it to ensure that no
damage has occurred in transit. If damage is
evident, please contact CONMED Customer
Service at one of the numbers listed on the inside
front cover of this manual.
The 100-120 VAC version of the CONMED
AER DEFENSE™ Smoke Evacuator includes an
AC power cord for connection to a standard (US)
outlet, 4’ ESU Activation Cord and an Operator’s
Manual. The 4’ ESU Activation Cord is shipped
with the 220-240 VAC version of the smoke
evacuator; the AC power cord and Operator’s
Manual are not.
Operator’s Manuals in languages other than
English and mains power cords for use in other
countries are available from CONMED.
Please contact CONMED Customer Service at the
numbers listed on the inside front cover of this
manual to order approved accessories available
for use with the CONMED AER DEFENSE™
Smoke Evacuator.
The third stage of filtration is a ULPA (Ultra
Low Penetration Air) grade filter whose high-tech
design captures particulates and micro-organisms
down to 0.10 µm at an efficiency of 99.9995%.
1-1
AER DEFENSE
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1.3 Cautions and Warnings
Please note that all Cautions and Warnings should
be read and understood before any use of this
equipment. This smoke evacuation system should
only be operated by personnel who have been
properly trained in its operation.
• The FilterOne™ is disposable, non-sterile and
non-serviceable. During use, this filter may
accumulate contaminated materials and fluids
that are potentially bio-hazardous. Please
handle this disposable filter according to your
local codes or regulations and hospital policy.
This filter may be disposed of or incinerated,
whichever is appropriate for your institution.
• The FilterOne™, when used with the
CONMED AER DEFENSE™ Smoke
Evacuator, should not be used when the filter
has expired which is indicated by a flashing
ORANGE LED light and an audible 5 beep
alarm. Failure to change the filter may result
in decreased efficiency and contamination of
the electric motor, vacuum pump, and sound
absorbing media within the unit as well as the
operating room environment.
• If fluid is expected to be aspirated by the
CONMED AER DEFENSE™ Smoke
Evacuator, a fluid collection device must
be installed in-line with the vacuum hose
assembly. Failure to install a fluid collection
device could cause filter blockage and
electrical damage.
• Do not operate this device in the presence of
flammable anesthetic gases, enriched oxygen
atmospheres or nitrous oxide.
• Refer servicing to qualified biomedical
technician or CONMED Technical Services.
• The AC power cord of the CONMED AER
DEFENSE™ Smoke Evacuator should
be connected to a properly polarized and
grounded receptacle of the same voltage
as listed on the nameplate on the smoke
evacuator.
WARNING: To avoid risk of electric
shock, this equipment must only be
connected to a supply mains with
protective earth.
• The mains disconnect device is the AC power
cord.
• If outside cover of the AER DEFENSE™
is removed, there is a possibility of electrical
shock if internal components are contacted.
• There is a possibility of unexpected suction
due to electrical interference or component
failure. If unexpected suction occurs, take
unit out of service immediately.
• Do not plug AER DEFENSE™ into same
power source as life support equipment.
Use a separate power source for life support
equipment.
• Place tubing and cords away from traffic
patterns.
• This equipment has been tested and found
to comply with the limits for medical
devices to the IEC60601-1-2: 2007. These
limits are designed to provide reasonable
protection against harmful interference in a
typical medical installation. This equipment
generates, uses and can radiate radio
frequency energy and, if not installed and
used in accordance with the instructions, may
cause harmful interference to other devices in
the vicinity. However, there is no guarantee
that interference will not occur in a particular
installation. If this equipment does cause
harmful interference to other devices, which
can be determined by turning the equipment
off and on, the user is encouraged to try to
correct the interference by one or more of the
following measures:
– Reorient or relocate the receiving device.
– Increase the separation between the
equipment.
– Connect the equipment into an outlet on
a circuit different from that to which the
other device(s) are connected.
– Consult CONMED Technical Services or
BioMedical Technician for help.
• Portable and mobile RF communications
equipment can affect the AER DEFENSE™.
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• The use of accessories, transducers and cables
other than those specified by CONMED,
may result in increased emissions or decreased
immunity of the equipment.
• The AER DEFENSE™ should not be used
adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary,
the AER DEFENSE™ should be observed to
verify normal operation in the configuration
in which it will be used.
• The AER DEFENSE™ Smoke Evacuator
and Electrosurgical Generator (ESU) share
a common power cord. Operating the AER
DEFENSE™ at full power and the ESU at
power levels greater than 150 W may have
a total line current greater than 12 A @120
V or 6 A @ 230 V, but will not exceed the
current rating of a 15 A / 7.5 A circuit.
• Do not block either the tubing or the filter.
If either becomes occluded or is significantly
restricted, the motor/blower may overheat
and cause the unit to fail.
• To prevent overheating, the smoke evacuator
must be positioned with a minimum
three inch clearance on all sides from any
obstructions for ventilation.
• To prevent overheating, do not use GoldVac
or ClearVac accessories continuously in the
Normal Suction Mode. Run at a maximum
continuous duty cycle in Normal Suction
Mode of 10 seconds ON and 30 seconds
OFF, at a suction level of 60%.
• Only use a Lap Tube accessory in the
Laparoscopic Suction Mode.
• When AER Defense is integrated in a system,
such as an Operating Room Control Center
through the Serial Interface Connector,
the organization responsible for system
integration must ensure safety by evaluating
the system using IEC 60601-1 2005 as a
basis.
• There are no user serviceable parts in this
equipment. Improper servicing of the
equipment could result in improper operation
and present a risk of electric shock.
• Using any other filter or accessory not
supplied by CONMED may cause damage to
the system and will void the warranty.
• If filter is inserted into the AER DEFENSE™
and the filter is not recognize and no green
LED lights illuminate, check to make sure
filter is inserted properly and completely.
If filter LED lights still do not illuminate,
contact your service representative.
• Care must be exercised in the installation of
hoses, adapters and fluid collection devices.
Failure to follow the procedures outlined in
this manual may result in overheating of the
motor and may void the unit warranty.
• If using a fluid collection device, do not
increase the vacuum setting to more than
50%. Failure to observe this maximum may
result in overheating of the motor and system
failure.
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1.4 Compatibility
This unit is compatible with other IEC 60601-1
certified units.
Electrosurgical equipment (ESU) connected to the
auxiliary Mains outlet must be certified according
to IEC60601-1, including Medical Electrical
System aspects. Everybody who connects
additional equipment to the auxiliary mains outlet
configures a medical system, and is therefore
responsible that the system complies with the
requirements of IEC 60601-1-1. If in doubt,
consult the technical services department of your
local representative.
Connecting electrical equipment to the auxiliary
will increase chassis leakage. Electrical equipment
connected to this outlet should be IEC 60601-1-1
compliant.
Underwriter’s Laboratories has not evaluated
system combinations, as it is the responsibility of
the user of this device to ensure compatibility with
other electrical devices.
List of compatible CONMED accessories:
• 60-8083-001, AER DEFENSE™ Pneumatic
Footswitch
• 60-8084-001, AER DEFENSE™ FilterOne™
• 60-7510-005, GoldVac Pencil, Push Button
• 60-7520-005, GoldVac Pencil, Rocker Switch
• 60-7530-005, GoldVac Pencil, Footswitch
• 60-7507-001, Adapter, non-sterile
• 60-7508-001, Adapter, non-sterile
• 138661, ClearVac
• 138663, ClearVac
• 62-5626-004, 4’ ESU Activation Cord
• 62-5626-005, 10” ESU Activation Cord
• 60-6806-001, Laser tubing, non-sterile
User-provided power cords for 230 V units
should be 1.02 mm diameter (18 AWG)
grounded, medical grade type.
• 60-8054-001, Adapter, non-sterile
• 60-6828-005, ClearVac
• 60-6829-005, ClearVac
• 60-6828-001, ClearVac
• 60-6829-001, ClearVac
• 60-6839-001, ClearVac
• 60-8056-001, Vacuum Control Assembly
(This Accessory must be mounted to the
system 5000 cart P/N 60-8040-001)
• 62-5862-001, AER DEFENSE™ AC Power
Cord, 15’
• 60-6805-001, Tubing
• 60-6810-001, Lap tubing
• 60-6815-001, Leep tubing, non-sterile
• 60-8086-001, Excalibur Plus PC Fixed Power
Cord Configuration Kit
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