Indications For Use; Contraindications; Warnings And Precautions; Important Symbols - Boston Scientific LABSYSTEM PRO EP Erste Schritte - Kurzanleitung

Read this document in its entirety prior to use.
ONLY
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Note: This software release includes features for setting up and using the CLEARSIGN™ Amplifier with the
LABSYSTEM™ PRO EP Recording System.
Availability of the CLEARSIGN Amplifier varies by country. Please check with your local representative for availability.

INDICATIONS FOR USE

• The LABSYSTEM PRO EP Recording system is intended for use as a data acquisition tool designed
to facilitate the gathering, display, analysis by a physician, pace mapping, and storage of cardiac
electrophysiological data.
When integrated with the Biosense Webster® CARTO® 3 system, the LABSYSTEM PRO EP Recording
System is designed to: a) send patient demographics to Biosense Webster CARTO 3, and b) acquire (from
Biosense Webster CARTO 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing
data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events
and images are created by the Biosense Webster CARTO 3 device and stored on the LABSYSTEM PRO
EP Recording System for review and insertion into the final clinical report. Integration also supports
bidirectional communication of stimulation pacing channel selection and information sharing between
the two systems.
• The CLEARSIGN Amplifier is intended to amplify and condition electrocardiographic signals of biologic
origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO
EP Recording System) that can record and display the information.

CONTRAINDICATIONS

None known.

WARNINGS AND PRECAUTIONS

Refer to the Warnings and Precautions Information Booklet for a comprehensive list of warnings and
precautions specific to the installation, setup and operation of the LABSYSTEM PRO EP Recording System and
CLEARSIGN Amplifier.

IMPORTANT SYMBOLS

Refer to the Warnings and Precautions Information Booklet for a comprehensive list of symbols used on the
hardware and labeling of the the LABSYSTEM PRO EP Recording System and CLEARSIGN Amplifier.

HOW SUPPLIED

1. Open the shipping carton and remove the system.
2. Visually inspect the system for any damage which may have occurred during shipping.
3. Do not use if package is damaged. If no shipping damage is noted, discard the packaging material. Otherwise,
use the original packaging to ship the damaged system back to Boston Scientific for replacement.

Handling and Storage

Store in a cool, dry place.
Refer to the Warnings and Precautions Information Booklet for additional environmental conditions.
2
Black (K) ∆E ≤5.0
LABSYSTEM PRO EP Recording system Getting Started Guide