Ec Declaration Of Conformity; Safety Instructions - Naggura Swop Physio Instruction Manual

5. EC Declaration of conformity

Naggura products are produced and marked in conformity with the directives hereby stated :
Low voltage : 2014/35/CE
Electromagnetic compatibility : 2014/30/CE
These products are manufactured according to the essential requirements established in the European Medical Devices Directive
(Annex II+III of Regulation (EU) 2017/745):
EN ISO 14971:2019; EN ISO 204117:2021; EN ISO 15223-1:2016; ISO 10993-1: 2018; EN ISO 10993-5:2009; EN ISO 109933-10:2013; EN
60601-2-52:2010+AC:2011+A1:2015; EN 60601-1-2:2015+A1:2020; EN 60601-1:2006+A1:2013+AC:2014+A12:2014+A2:2020.
The Swop line has a guarantee
nance or repairs performed by unauthorised persons.

6. Safety instructions

Responsibility of the owner
Naggura treatment tables are only meant to be used by professional personnel in physiotherapy, rehabilitation, examination, mas-
sage and aesthetics fields.
It is the responsibility of the owner to ensure that training is given to all operators and third parties (like for example cleaning per-
sonnel) on safe use of the treatment table, and that they have read and understood all the operating and safety instructions.
Only trained operators may use the treatment bed. Please keep the manual in a place where it is easily accessible to all users, and
make it an important part of your employee training program.
Safety on installation and electricity
- Place the table in a space with free access from the 4 sides. Do not place the table against the wall or against any obstacles.
- Do not use the table in a high-humidity environment or in so-called "wet rooms" (hydrotherapy spaces). Any prolonged exposure to
high moisture conditions may affect the electrical components and may result in failure.
- Check the technical data and electrical parameters to ensure that the supply voltage meets the technical specifications of the
table. If not, contact your supplier before connecting the device.
- Make sure that the unit is correctly plugged into an earth intake, following the local and national requirements and standards.
- Make sure that the power cable is correctly and safely placed in such a way that it cannot get trapped between any mechanism.
- Pay special attention that the supply cable does not get pinched under the feet of the table, (e.g. after having moved the table on
its wheels).
- If the table accidentially gets wet, unplug it immediatelly.
- Do not leave chlidren unattended near the table.
- Unless being monitored or instructed by personnel who can be responsible for their personal safety, the people who have physical
obstacles, tactile disorders, mental disorders, lack of experience, common sense or children, are not allowed to use the equipment.
- Do not use the device near electromagnetic transmitters. Read and follow all the information about electromagnetic compatibility
(EMC) in page 19.
- If the power cord or plug is damaged, please contact the distributor, service center or experienced technicians for reparing.
- Please pay attention that the continuous working times should be "Max.2Min. ON; 18Min. OFF", when operating the motor.
of two (2) years in all parts. The manufacturer will not be held responsible for the results of mainte-
For further information on guarantee terms, please contact your distributor.
Instruction
Manual
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