55000-00011_002_01 – 1756789 – 2017-09-06
10
1
Important information regarding safe use
1.1
Details for the identification of the system
This instruction manual is solely intended for systems with rating plates that show the
following information:
System identification
– TruLight single
4038110
– TruLight mobile
4038120
– TruLight wall
4038130
– TruLight duo
4038210
– TruLight trio / quad
4038310
1.2
Details for identification of the instruction manual
Updated status of this instruction manual
To indicate the updated status of the instruction manual, all pages are marked with a
7-figure identification number and the status:
Identification of the instruction manual
– Material no.:
1756789
– Date of publication:
2017-09-06
– Document number:
55000-00011_002_01
This identification coding is binding for the validity of the instruction manual and
must not be removed irrespective of the type of publication (in printed or electronic
form, in full or excerpted).
1.3
Designation of groups of individuals
The following groups of individuals are named in this instruction manual.
1.3.1
Operator
An operator (e.g. a medical practice, hospital, etc.) is any natural or legal person who
owns a device and is authorised to use it or by whose authority the device is used.
• The operator is obliged to provide a safe device and appropriately instruct the
user regarding operation and proper use of the device.
1.3.2
User
Users are individuals who by their qualifications or an appropriate briefing by
specialist personnel are authorised to operate and work with the device.
• Users are fully responsible for the safe application of the device for the purpose
intended.
1.3.3
Specialist personnel
Specialist personnel means authorised individuals, generally employed by the
operator, who:
• have acquired their knowledge by a technical education in the field of medical
technology,
• can assess the work they carry out on the basis of professional experience and
briefing about safety regulations, and can recognize possible hazards in their
work.
• In countries where there is certification regarding performance of work in the
field of medical technology, classification as specialist personnel requires the
corresponding authorization.
1.4
Information for operators
Procedural guidelines
The device has been manufactured to the current state of technology and is
operationally safe.
• The device can nevertheless be a source of danger, especially when it is operated
by inadequately trained personnel or is used incorrectly or not for the purpose
intended.
