XO FLEX – Installation instructions
Checking
the unit
46
The medical grade isolating transformer shall be installed out of reach of the patient. In cases
where this is impractical (e.g. if the dental operatory is small), the isolating transformer shall be
installed in a locked cabinet.
The operator of the dental unit shall avoid simultaneously touching the patient and the isolating
transformer/external monitor/PC (including any corded keyboard/mouse or other accessories
connected to the PC).
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.
6
CHECKING THE UNIT
ADJUSTMENT OF THE INSTRUMENT BALANCE SUSPENSION
All instruments should be in perfect balance when lifted forward – i.e. you should feel
no dragging from the instrument hose when holding an instrument!
Figure 63 – Medical electrical system
