Copyright © Lojer Oy, 2021 | 05/2021
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1 Lojer 4040X General Examination Tables
Lojer 4040X (and 4040XH) examination tables are designed for wide range of examination and operation
procedures given on the lying surface (not for anesthetized patients) with continuous supervision. Examination
table are intended to be used by healthcare professionals in hospitals, healthcare centers and other medical
facilities.
This document gives instructions for operating and maintaining the device. Please familiarize yourself with
these instructions before using the device. Use the device only as described and for the specified applications.
Store these instructions in an appropriate way, making sure that the instructions are available to all possible
users throughout the life of the device.
To avoid injury, follow the instructions given in this document.
To ensure safe use and not invalidate your warranty, use the product only as described in these
instructions.
1.1 Intended purpose
4040X Examination Tables are non-invasive class 1 medical devices (EU Medical Device Regulation
2017/745, rule 13, hydraulic version under rule 1) for transient and short-term use and intended to be used to
support the patient (not anesthetized patients) with continuous supervision, during medical examination.
Tables adjustable mechanics are used to manipulate and position the table to allow patient support, closer
examination of a portion or the entire patient, and the ability to move the patient on and off the table safely.
The tables are intended to be used by Intended User in healthcare centers, hospitals and other medical
facilities in indoor conditions. Tables are not intended to be used in home environment.
1.2 User groups
The Owner or Holder
is any natural or legal person who have ownership of the product. The owner is
responsible for the safe use of the product and is responsible for ensuring that the product is always used
safely including maintenance, cleaning and disposal. It is the responsibility of the holder to ensure that all
users, including temporary staff, have received appropriate training in the use of the equipment and are familiar
with the risks involved in using the equipment and the dangers of improper use.
The Intended User
is a person who, by virtue of his education, experience or familiarization, is capable of
operating the device, must be able to anticipate and identify risks associated with the use of the device and
be able to assess the patient's clinical status, suitability to use the device and treatment
risks. It is the user’s
responsibility to ensure that the treatment meets the requirements of all applicable local laws and regulations.
A Patient
is a person who needs the device for treatment; is weak, ill, injured or needs the device otherwise
to compensate functional limitations, e.g. handicapped persons.
Obligation for incident reporting:
User and/or patient should report any serious incident that has occurred
in relation to this device to the manufacturer (Lojer Oy) and the competent authority of the Member State in
which the user and/or patient is established.
1.3 Intended clinical benefits
Indications for examination are typically symptoms of a disease or sensation of pain. Lojer 4040X Examination
Table provides a support for a patient when these symptoms are examined by health care professional. Lojer
4040X Examination tables have standard equipped paper holder to protect the lying surface and patient.
1.4 Contra-indications
The device has no contra-indications.
