Carilex VT ONE - I Ortant Notes for Safe Use; Esi Nation of T E Rou S of in I I Uals; Otes for T E Users; Instruction

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Instructions for Use | Carilex® VT • One
Iortant notes for safe use
 esination of te rous of iniiuals
The named groups of persons in these Instructions for use are as follows
Oerators
An operator (surgical supplier, health insurance, clinic, etc.) is any legal person,
which owns the Carilex® VT • One suction pump and uses it, or on whose behalf
the device is in use. The operator is responsible for providing a safe device and to
instruct the user properly on the operation and the use of the device.
User
Users are people who are entitled, due to their training or a corresponding
instruction, to:
• Operate the Carilex® VT • One suction pump
• Supervise patients using the device for therapy purposes
Users are fully responsible for the safe and correct use of the device. A review of
the functions has to be carried out and the proper condition of the device has to
be checked and conrmed by the user before each use or transfer for use.
rofessionals
The authorized persons are skilled personnel, who are as a rule, the employees of
the operator and who:
• Have acquired their knowledge through professional training in the medical-
technical eld
• Carry out their activity on the basis of professional work experience and
instructions according to safety-related regulations and are able to detect
possible hazards during work.
In countries in which the pursuit of an activity in the medical-technical area
is certified, the classification as qualified personnel is subject to appropriate
approvals.
atients
Patients in the sense of these instructions are persons in need of care, who use
the Carilex® VT • One suction pump for therapy purposes.
 otes for te users
Note that the Carilex® VT • One suction pump should only be used by persons
who have been trained in the operation and the intended use of the device.
 Instruction
The training of users on how to use the device must be carried out by the
qualied personnel of the operator using the device. If the device is approved
for the customer, then it is obligatory to comply with the instructions of this
guidance.
ae rous of ersons
Trainin on te eice
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