Strictly Follow These Instructions For Use; Maintenance; Accessories; Not For Use In Areas Of Explosion Hazard - Dräger Fabius Instructions For Use Manual

For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

WARNING
Strictly follow these Instructions for Use. Any
use of the medical device requires full under-
standing and strict observation of all portions
of these instructions. The medical device is
only to be used for the purpose specified
under "Intended Use" on page 16 and in con-
junction with appropriate patient monitoring
(see page 9). Strictly observe all WARNING
and CAUTION statements throughout this
Instruction for Use and all statements on
medical device labels.

Maintenance

WARNING
The medical device must be inspected and
serviced regularly by trained service person-
nel.
Repair of the medical device may also only be
carried out by trained service personnel.
Dräger recommends that a service contract be
obtained with DrägerService and that all
repairs also be carried out by them. Dräger
recommends that only authentic Dräger repair
parts be used for maintenance. Otherwise the
correct functioning of the medical device may
be compromised.
See chapter "Maintenance".

Accessories

WARNING
Only the accessories indicated on the list of
accessories 9052102 enUS (1st edition or hig-
her) have been tested and approved to be
used with the medical device. Accordingly it is
strongly recommended that only these acces-
sories be used in conjunction with the specific
medical device. Otherwise the correct func-
tioning of the medical device may be compro-
mised.
8

Not for use in areas of explosion hazard

WARNING
This medical device is neither approved nor
certified for use in areas where combustible or
explosive gas mixtures are likely to occur.
Safe connection with other electrical equipment
WARNING
Electrical connections to equipment which is
not listed in these Instructions for Use should
only be made following consultation with the
respective manufacturers.

Safe networking of computers

When networking with electrical devices, the oper-
ator is responsible for ensuring that the resulting
system meets the requirements set forth by the fol-
lowing standards:
– EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
medical electrical systems
– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compati-
bility; Requirements and tests
– EN 60601-1-4 (IEC 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
Follow associated Assembly Instructions and
Instructions for Use.
Instructions for Use Fabius MRI SW 3.n