Trumpf 1717020, Инструкция по эксплуатации

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Important information
4990113_030_01 — 2069106 — 2017–11–02
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1.4 Safety instructions
Safety instructions is defined as measures to protect the user and
patient from dangers that might occur through the use of the
operating table.
The medical device is subject to special precautions regarding
electromagnetic compatibility (EMC). Installation and
commissioning must be done in accordance with the EMC notes
specified in chapter 21 on page 85.
In critical situations during an operation, changing the patient's
position by means of operating table movements (level position,
Trendelenburg) may be necessary to facilitate lifesaving measures.
In the rare event that an operating table fails during surgery,
alternate measures may need to be taken to reposition the patient.
These measures include supporting the patient with additional pads
or transferring the patient from the operating table. When using the
operating table column in an imaging system, free access to the
patient must be ensured by first driving away or swiveling away the
imaging system.
1.4.1 Safety during operation
• These operating instructions must be read and understood in full
by the operating personnel, especially the chapter “Safety
instructions”, prior to start-up or, if appropriate, communicated by
means of an in-house training session taking the level of
professional training into account. The instruction manual must be
strictly observed and made available at the location of use.
• Only use the operating table with the defined products
(chapter 1.2) for the purpose set out in the “Proper use of the
equipment” (chapter 1.1).
• The values defined under “Technical data” (chapter 16) must be
observed for the operating table.
• All work with or on the operating table (set-up, operation,
maintenance, decommissioning, transport, and disposal) may
only be performed by trained staff.
• Risk of material damage to the electronics due to condensation.
When transitioning from a cold to a warm environment or vice
versa, moisture can form inside the operating table and cause a
WARNING
Patient hazard due to malfunction!
Given the present state of the art on the market, the possibility of an
operating table malfunction cannot be fully excluded. While very
unlikely, there does exist a possibility that the motorized table
functions may fail during surgery.