Regulatory Requirements
Telligence
75PM000224A / 10 August 2022 / Ver. H
Regulatory Requirements
You must follow the regulatory guidelines listed below in order to maintain proper operational
compliance.
Inspections
Only qualified technicians shall place Call systems in operation. Before commissioning of the
call system, a complete inspection shall be carried out, including the visual and functional
inspection of the call system and the equipment.
In case of any alterations or repairs to the call system or its extent, complete inspections shall
be performed on the altered system elements. Such inspections may be limited to only those
elements provided that such alterations or repairs do not affect the remaining call system
elements.
Inspections shall be performed whenever it is suspected that the continuous call system
function may be impaired, or whenever irregularities are perceived in some function. The
qualified technician shall be called when deemed necessary.
Maintenance
Maintenance or repair work should be performed only by a qualified technician. When the call
system is shut down completely or in part, only qualified technicians and system operators
should arrange with the appropriate facility authority for the related rooms to be provided with
other control means until the system is switched on again. After each alteration or repair, the
nominal condition of the call system shall be re-established, and an inspection shall be
performed. Maintenance work includes:
• Servicing of system elements
• Replacing of construction elements with limited service life (e.g., batteries)
• Installing of necessary system updates (when applicable)
• Readjusting and aligning of construction elements and equipment
• Observe all safety related markings on the cover of the NGGTWY2 when servicing the unit
Reporting
In accordance with REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL of 5 April 2017 on medical devices and United States Code of Federal
Regulations Title 21 CFR Part 803, users and patients should report any serious incidents that
occur in relation to any medical device product. Such incidents should be reported to both the
manufacturer and the competent authority of the Member State (EU) or country in which the
user and/or patient is established.
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