AtriCure ASB3 Instructions For Use Manual

1.

Attention: Consult accompanying documents

Dangerous Voltage

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 60601-1-2:2001. 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) C001237-ASB/ASU Footswitch Interface
Cable, and (3) A000479-ASB3 PSS Interface Cable.

Caution: Federal (U.S.A.) law restricts this device to sale by
or on the order of a physician.

Manufactured for:
AtriCure, Inc.
7555 Innovation Way
Mason, Ohio 45040
Customer Service: 866-349-2342
[e-mail]
www.atricure.com

European Representative:
Köntges SPRL
Avenue Hellevelt 35
B-1180 Brussels Belgium
Tel: [phone]
FAX: [phone]
e-mail: [e-mail]

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4.

Type CF Defibrillation-Proof Applied Part
Patient Isolated Equipment

Type CF Applied Part Not Defibrillation-Proof
Patient Isolated Equipment

Alternating Current

Equipotential

Footswitch

Fuses

Power OFF

Power ON

Environmental Conditions: (1) operational temperature +10°C to
+40°C, (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.

Information in this document is subject to change without notice. Reproduction in any manner whatsover
without the written permission of AtriCure, Inc. is strictly forbidden. AtriCure and the AtriCure Logo are
trademarks of AtriCure, Inc. AtriCure disclaims proprietary interest in the marks and names of others.
January 2009 Printed in the USA.

P000402.K

HANDPIECE

CR

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EMT1

MicroPace - PSS1

Coolrail - MCR1

Isolator Transpolar Pen

MAX1

MAX5

MLP1

EML2

EMR2

OLL2

OSL2

Isolator Clamp

OLL1