2
Patient safety
Read Instructions for Use prior to Use.
Application only under regularly supervision by
specially trained staff.
Operation
Make sure unit is firmly in position. This
applies in particular to use with infusion
stands or wall rails. Never place more than 3
Perfusor fm units on top of one another.
Prior to use:
Always check audible and visual alarms. This
likewise applies where appropriate to the staff
call.
Patient connection should only be made
when device is switched on.
Interrupt connection when changing syringe
to avoid danger of incorrect dosage.
Make sure syringe is correctly positioned.
Whenever inputs are made, value displayed
is to be compared to value entered. Do not use
unit unless values coincide.
Appropriate cannulas/catheters are to be
used for the administration set/med. applica-
tion.
Make sure there are no kinks in tubing;
ensure unimpeded flow.
Make exclusive use of disposables. Replace
after 24 hours.
Use only compatible combinations of
equipment, accessories, working parts and
disposables.
The use of not recommended resp.
incompatible disposables may influence the
technical specifications.
Operational reliability is only guaranteed if
use is made of accessories which have been
tested/authorised and thus recommended by
the manufacturer, B. Braun.
Installation in medically used rooms must
comply with the appropriate regulations (e.g.
VDE 0100, VDE 0107 or IEC-publications).
Observe national specifications and deviations.
The infusion lines should be placed in such a
way that the syringe cannot be pulled out of its
fixation because of uncontrolled drawing.
Possible explosion hazard if used in presence
of flammable anaesthetics.
Other components
These must conform to the same
requirements as the administration set.
Where several infusion lines are connected
on one singular vascular access the possibility
of their exerting a mutual influence vice-versa
cannot be excluded.
Operation in the occlusion pressure range
may affect accuracy.
Safety Standards
Perfusor® fm satisfies all safety standards for
medical electrical devices in compliance with
IEC/EN 60601-1 and IEC/EN 60601-2-24.
The EMC-requirements (electro-magnetic
compatibility) according to IEC/EN 60601-1-2
and IEC/EN 60601-2-24 are fulfilled. If the
equipment is operated in the vicinity of other
equipment which may cause high levels of
interence (e.g. HF surgical equipment, nuclear
spin tomography units, mobile telephones etc.)
maintain the recommended protective
distances for these devices. Under certain
conditions malfunctions may occur which lead
to a device alarm with permanent alarm tone
(see also alarm conditions, page 12).
Interferences may occur e.g. at electro-
magnetic fields > 10 V/m resp. electro-
magnetic discharges > 8 kV.
Attention: Consult accompanying documents !