General Information - KONG Italy X-TRIM 4 Manual

CHAPTER

2 GENERAL INFORMATION

The information provided by the manufacturer
(hereinafter referred to as information)
must be read and clearly understood by
the user prior to using the Medical Device
(MD hereafter). The information regards the
description of the features, performance,
assembly, disassembly,
preservation, disinfection, etc. of the device.
Even though the information offers tips on
use, this information shall not be considered
as a user manual under actual conditions of
use.
WARNINGS AND
LIMITATIONS OF USE:
- this device shall be strictly used by people
who are physically fit, trained (instructed
and taught) to use the device and with
specific experience
the patient or, during training activities,
by people under direct supervision of the
trainers/ supervisors who guarantee the
safety thereof,
- do not use the device before fully reading
and understanding this user manual,
- strictly follow the manufacturer's
information, improper use of the device is
hazardous,
- modifying and/or repairing the device is
strictly forbidden,
- all checks described in chapter 7 must
be carried out prior to and after using
the device. In case of any doubt on
the efficiency of the device, the user
must replace it immediately,
- non-compliant use, deformations, falls, wear,
chemical contamination, exposing textile/
plastic components/devices to temperature
below -30°C or above +50°C and metal
components/devices
www.kong.it
2
maintenance,
regarding moving
to temperatures
Original version in Italian dated 10/01/2022
exceeding 100°C are some examples of
causes that can reduce, limit and end the
life of the device,
- Prior to any rescue operation, be keen not to
exceed the capacity indicated in paragraph
3.3,
- in order to reduce risks of exposure to /
transmission of infectious diseases, clean
and disinfect the device as indicated in
chapter 5,
- improper use of the patient immobilisation
systems can jeopardise the safety of the
patient,
- always check the compatibility of the devices
used alongside the device by consulting the
relative manufacturer's information,
- use of spare parts or optional components
different from the ones indicated in
paragraph 3.4 can be hazardous,
- do not expose the device to sources of heat
and at contact with chemical substances.
Reduce exposure to direct sunlight as
much as possible. At low temperatures and
in the presence of humidity, formation of ice
could reduce flexibility and increase cutting
and abrasion-related risks on textile and
synthetic devices.
- Report to the manufacturrer and the
competent authority of the member state
where the user and / or patient is established
any serious incident occurring in relation to
the MD.
All our devices are tested/ checked piece
by piece in compliance with the procedures
laid down by the Quality System certified
in accordance with the UNI EN ISO
9001 standard. Laboratory tests, testing,
information and standards do not always
reproduce the practical result. Thus, the
results obtained under the actual conditions
of use of the device in the natural environment
may differ, even considerably at times.
The best information lies in the continuous
practical use under the supervision of
skilled/expert/qualified people.
Warning: not suitable for
use in an ATEX environ-
ment (Directive 94/9/CE)
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855.12 X-TRIM 4