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Servicing in the New Era

Essenz Focus

The new Essenz Focus offerings and capabilities have been designed to deliver on the hardware & software servicing needs of the New Era of Perfusion.

Building on the foundation of trust you have placed in LivaNova’s technical service teams for the past 50 years.

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Keeping sight of what matters

Custom Packages

Four tiers to meet your individual needs and facilitate budget control

Relationships

A dedicated technical service team you know by name

Responsiveness

State-of-the-art, dynamic structure through a combination of on-site and remote channels

Reliability

Dedicated Essenz Experts providing advanced software, data and installation support

Four tiers to choose from

Essenz Focus Service Packages

Full Protection

Our full protection offer. Essenz Focus Maintain plus spare parts and corrective maintenance work.

Full Protection Plus

Our full package completed with aesthetic interventions and HL7 integration.

Data

Unlocks the Essenz Perfusion System capabilities by enabling regular upgrades and feature releases, preventing compatibility or obsolescence issues

Maintain

Preventive maintenance contract including Essenz Focus Data + regular annual review of the hardware

Safety Information

Summary of Safety & Performance Information for Essenz Perfusion System

Please note the Essenz information is available in selected geographies only.

1. INDICATIONS FOR USE / INTENDED PURPOSE

Heart-Lung Machine

Devices are intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.

US: Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Essenz Patient Monitor

The Essenz Patient Monitor software is a modularly structured software program package that is exclusively used with LivaNova heart-lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass procedures as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually. The LivaNova Perfusion System Monitor is a panel PC intended to be exclusively used with LivaNova heart lung machines as a base and user interface for the Essenz Patient Monitor software.

CONTRAINDICATIONS: No contraindications are known if the devices are used for the purpose described and in accordance with the stated operating conditions. Do not use the devices for any purpose other than indicated.

WARNINGS: The devices must be used in accordance with the instructions for use provided. For a complete listing of warnings please refer to the Instructions for Use. Medical intervention and therapeutic procedure must not be based solely on the Essenz Patient Monitor perfusion records (reports).

PRECAUTIONS: Federal law (U.S.A.) restricts these devices to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use. The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer.

Not approved in all geographies. Please contact us through the LivaNova website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.

Legal Manufacturer:

LivaNova Deutschland

Lindberghstrasse 25D-80939

Munich, Germany

Essenz Patient Monitor distributed in the US by:

LivaNova USA

14401 W 65th Way

Arvada, CO 80004, USA

Distributed in Canada by:

LivaNova Canada Inc.

280 Hillmount Road, Unit 8

Markham, ON L6C 3A1, Canada

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