Owandy One - 1.9 Installation precautions; 1.10 Liability and operators

EN
ONE – User manual Page 7/44
1.9 Installation precautions
Warning
The computer connected to the sensor MUST necessarily comply with standard IEC 60950-1.
.
Warning
The One sensor is an electrical medical device requiring special precautions regarding electromagnetic
compatibility. Please observe the recommendations in this manual during the commissioning and use
of the equipment.
Warning
The use of cables or accessories other than those specified in this manual can cause an increase in the
emissions or a reduction in the immunity of the One sensor.
1.10 Liability and operators
Installer: the installation of the kit requires computer skills relating to both equipment and software. Follow the
recommendations and guidelines of the installation chapter to install the equipment and software.
User: the kit must be used by a dental practitioner or radiologist with computer skill.
Warning
The sensor should never be opened by the user. Only the manufacturer is authorised to open and make
repairs to the sensor. Return the equipment to the distributor in case of malfunction and/or if the
documentation you possess does not contain the necessary information for the (authorised)
maintenance of the malfunctioning equipment.
Warning
Any modification of the ONE device is forbidden. All repairs of this same device can only be performed
by Owandy Radiology personnel.
The manufacturer will not be liable if:
 Interventions or repairs have been made by persons without the authorization of the manufacturer or
distributor and are not part of accepted interventions.
 The equipment is used with an installation that is not compliant with the applicable standards and decrees
- in particular when not compliant with the IEC 60601-1 standard relating to the security rules for electro
medical systems. Make sure the installation of the equipment is compliant with the applicable regulations.
 Used in ways other than those mentioned specifically in this manual (use of the kit in normal conditions of
use and in compliance with its intended purpose).