Introduction
Other documents relating to this product
1
Maquet Orchide
IFU 04661 EN 02
7 / 44
1.2.3.3 Groups of people
Users
• Users are persons who are authorised to use the device, either by virtue of their qualifications
or as a result of receiving training from a qualified person.
• Users are responsible for the safe use of the device and for ensuring that it is used as inten-
ded.
Qualified personnel:
• Qualified personnel are persons who have acquired knowledge through specialised training
in medical technology or due to their professional experience and knowledge of the safety
rules relating to the tasks performed.
• In countries where certification is required to exercise a medico-technical profession, person-
nel must hold the necessary authorisation in order to be considered as qualified.
1.3 Other documents relating to this product
• Installation Manual (P/N ARD04664)
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 [8Page39].
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.
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