Getinge Lucea 100 User Manual

1
Introduction
Liability
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LUCEA 50-100
IFU 01741 EN 11
1.4 Liability
Modifications to the product
The product must not be modified in any way without the prior written consent of Getinge.
Compliant use of the device
Getinge may not be held liable for any direct or indirect damage that results from actions not set
out in this user’s manual.
Installation and maintenance
Installation, maintenance and decommissioning operations must be performed by trained person-
nel, approved by Getinge.
Training on the device
Training must be provided directly on the device by personnel approved by Getinge.
Compatibility with other medical devices
Only medical devices approved in accordance with IEC 60601-1 or UL 60601-1 should be in-
stalled on the system.
The compatibility data is detailed in the chapter entitled Technical specifications [8Page51].
The compatible accessories are detailed in the chapter concerned.
In the event of an incident
Any serious incident occurring in connection with the device must be notified to the manufacturer
and the relevant authority of the member state in which the user and/or patient is based.
1.5 Expected service lifetime
The expected service lifetime of the product is 10 years.
This service lifetime does not apply to consumables such as sterilisable handles.
This 10-year service lifetime applies subject to annual periodic checks being performed by per-
sonnel trained and approved by Getinge; see Maintenance schedule [8Page50]. After this
time, if the device is still in use, an inspection must be carried out by personnel trained and ap-
proved by Getinge to ensure the continued safety of the device.
1.6 Warranty
For details of warranty conditions, please contact your local Getinge representative.

Getinge Lucea 100 Specifications

General

Brand	Getinge
Model	Lucea 100
Category	Medical Equipment
Language	English