XO FLEX – Instructions for use Installation
10
XO FLEX unit must be installed by an XO authorized service provider.
Authorized service providers are listed under “Distributors” at xo-care.com.
WARNING: To avoid the risk of electric shock, this equipment must be connected to a
supply mains with protective earth.
When connecting an external PC (including monitor) to the XO FLEX unit, the
external equipment must be powered by a medical grade isolating transformer (e.g.
XO part number: XO-620).
The external equipment must also comply with the applicable standards, e.g.:
• IEC 60950-1 (information technology equipment) or IEC 62368-1 (electronic
equipment within the field of audio, video, information and communication
technology), and
• IEC 60601-1 (medical electrical equipment)
When external equipment is connected to the XO FLEX unit to create a medical
electrical system, the requirements of IEC 60601-1, 3
rd
edition, must be complied
with.
It is the responsibility of the person/organization installing and/or modifying the
equipment to ensure that the system conforms to applicable legislation, e.g.
Directive 93/42/EEC, or Regulation (EU) 2017/745, and the requirements of IEC
60601-1, 3
rd
edition.
Installation instructions for XO FLEX can be downloaded from xo-care.com.
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