AtriCure ASB3 Instructions For Use

IFU-0219.A
2022/05
AtriCure Switch Matrix ASB3
Instructions for Use
The AtriCure ASB3 Switch Matrix is a reusable accessory interface module that allows
simultaneous connection of AtriCure® Isolator™ Transpolar™ ablative handpiece and
pen devices to the ASU RF generator. Devices will be operational only when the ASB3
selector switch is set to the device specific position. Please refer to the applicable
handpiece and pen device Instructions For Use. Please refer to the ASU User's Manual
for descriptions of RF energy delivery, modes of operation, output power, operating
frequency, and approved temporary cardiac pacing and stimulating accessories.
The ASB3 has been tested and found to comply with the limits for medical devices in
IEC 60601-1-2:2015. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. The ASB3 generates 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 the
ASB3 does cause harmful interference to other devices, which can be determined by
turning the ASB3 off and on, the user is encouraged to try to correct the interference by
one or more of the following measures; (1) reorient or relocate the receiving device, (2)
increase the separation between the ASB3 and the other devices, (3) connect the ASB3
into an outlet on a circuit different from that to which the other device(s) are connected,
and (4) contact the AtriCure service representative for assistance.
Inspect the following interface cables for any signs of physical damage to the cable and
connectors. If physical damage is found or the interface cables do not perform within
specification, notify AtriCure. All returns must have approval from AtriCure. The cables
include: (1) A000442-ASB/ASU RF Interface Cable, (2) A000473-ASB/ASU Footswitch
Interface Cable.
Caution: Federal (US) law restricts this device to
sale by or on the order of a physician
Environmental Conditions: (1) operational temperature +10°C to +40°C (50°F to 104°F),
(2) storage temperature -35°C to +54°C, and (3) humidity 15% to 90% relative humidity.
Perform annual preventative maintenance procedures to ensure all ASB3 components
are functioning properly, including but not limited to: (1) electrical power cords for
fraying, damage, and proper grounding, (2) AC power switch, (3) indicator damage
(Power On, Footswitch Present, or Handpiece Select), (4) handpiece connector damage,
cracking or inability to insert and latch handpiece plug, (5) carrying handle damage,
inability to latch or rotate, (6) rubber feet damage, cracking or inability for the ASB3 to
remain stabile on a flat surface, (7) interface cable fraying or damage, and (8) footswitch
connector damage cracking or inability to insert and latch footswitch plug.
The ASB3 does not have any serviceable parts. For servicing issues, contact AtriCure, Inc.
The ASB3 Accessory Cleaning and Disinfection Instructions; (1) use a mild detergent
(prepared to its specifications) and a damp cloth to clean the exterior of the Switch
Matrix, (2) do not submerge or allow fluids to enter the chassis, (3) do not use caustic,
corrosive, or abrasive cleaning materials, and (4) the ASB3 and auxiliary device cable
cannot be sterilized.
Types and rating of fuses: (1) 100-120V, 220-240V, ~50/60 Hz, and (2) 1.25A/250V,
T-lag, 5 x 20mm, UL Recognized, IEC Approved. Replace fuses as marked.
Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components.
Disclaimer - Under no circumstances will AtriCure, Inc. be responsible for any incidental,
EN
special or consequential loss, damage, or expense, which is the result of the deliberate
misuse of this product, including any loss, damage, or expense which is related to
personal injury or damage to property.
Dangerous Voltage
Type CF Defibrillation-Proof
Applied Part
~
Alternating Current
Equipotential
Footswitch
Power ON
Caution
Federal (USA) law restricts this
device to sale by or on the order of
a physician.
90%
Humidity Transit Limit
%
15%
Importer
Catalogue Number
National Institute of
Metrology Standardization
and Industrial Quality
BR REP
Commercial Name: AtriCure Synergy Ablation System
Technical Name: RF Ablation Equipment
Contents:
01 Unit IFU
01 Unit of the AtriCure Switch Matrix
01 Cable – PSS Interface
01 Kit, Pin adapter
01 Footswitch Interface Cable
01 Power Cord
ANVISA n°: 80117580989
Importer: Emergo Brazil Import Importação e Distribuição de
Produtos Médicos Hospitalares Ltda. Avenida Francisco
Matarazzo, 1.752, Salas 502/503, Agua Branca, São Paulo-SP,
CEP – 05001-200 CNPJ: 04.967.408/0001-98
Email: brazilvigilance@ul.com
Technical Manager: Luiz Levy Cruz Martins, CRF-SP: 42415
Manufacturer
Authorized
representative in the
BR REP
Brazillian Community
Country of Manufacture
US
Refer to Instruction
Manual
Fuses
Power OFF
Non-Sterile
Waste Electrical and
Electronic Equipment
129°F
(54°C) Temperature Transit Limit
-31°F
(-35°C)
Model Number
Serial Number
Lot Number
Non-Ionizing Radiation
AtriCure Inc.
7555 Innovation Way
Mason, Ohio 45040
USA
+1 866 349 2342
+1 513 755 4100