TF.16 IFU StarDevice.003.10-EN 2021-01-12
prepared by Pulavskyi A., Kolyesnik O.
9
2 WARNINGS AND SAFETY INSTRUCTIONS
2.1 SAFETY SINGS ON THE DEVICE
The manipulator is protected by reinforced insulation and has no galvanic connection to
the ground.
IP20
– A degree of protection against penetration of solid objects.
2.2
WARNINGS AND SAFETY INSTRUCTIONS
The user must have the proper technical and medical qualifications and know the user’s
manual of this device in order to use this device. All maintenance procedures recommended
by the manufacturer must be performed by personnel with appropriate approvals.
It is allowed to use the device in medical centres, in rehabilitation and sports medicine
centres, SPA centres, massage rooms for adult patients (23 years and older).
The operator must inspect the housing of the electronic unit, the manipulator and the tips,
as well as the power cord and the manipulator cable before using the device, to ensure there
is no external damage. Operation of the device with a damaged housing of the electronic
unit or a manipulator, a damaged manipulator cable or a power cord is prohibited!
This device complies with the requirements of the electrical safety standard EN
60601-1: 2010.
It is necessary to connect the device to the mains supply in accordance with the national
electrical safety regulations.
The device must be placed beyond the reach of a patient,
especially children, as the device has small working tips,
moving parts and removable parts that can cause injury (small
elements can be swallowed).
Certified and safe materials are used for the device. Potentially, a patient's allergic reaction
to parts that come in contact with the skin surface during the treatment procedure is possible.