39
DDoo
nnoott
use Dopplers in the presence of
flammable gases such as anesthetic agents.
Do
not
use in the sterile field unless
additional barrier precautions are taken.
Do
not
: •
Immerse in any liquid
(Except
FD1+/FD3
probes)
• Use solvent cleaner
• Use high temperature
sterilizing processes (such
as autoclaving)
• Use E-beam or gamma
radiation sterilization
This product contains sensitive
electronics, therefore, strong radio
frequency fields could possibly interfere
with it. This will be indicated by unusual
sounds from the loudspeaker. We
recommend that the source of
interference be identified and eliminated.
Do
not
use on the eyes or scrotum.
If outputs 1 and 2 are used
simultaneously, the system should
comply with EN60601-1-1.
Any equipment connected to outputs 1 or
2 should comply with EN60601-1,
EN60950, EN60065, EN60335 or EN61010.
Do
not
dispose of batteries in fire as this
can cause them to explode.
Do
not
attempt to recharge normal dry-
cell batteries. They may leak, cause a fire
or even explode.
Dopplex Dopplers are screening tools to
aid the healthcare professional and
should not be used in place of normal
vascular or fetal monitoring. If there is
doubt as to vascularity or fetal
well-being after using the unit, further
investigations should be undertaken
immediately using alternative techniques.
WWAARRNNIINNGG//CCAAUUTTIIOONNSS
&&
SSAAFFEETTYY
WARNING!!
Federal
law
restricts
this
device
to
sale
byy
or
on
the
order
of
a
licensed
practitioner.
IMPORTANT
Before
using
yyour
Fetal
Dopplex,
please
studyy
this
manual
carefullyy
and
familiarize
yyours
elf
with
the
controls,
displayys,
features
and
operating
techniques.
FD1+
/
FD3
The main unit is not waterproof and must
not be immersed. For underwater use
where contamination or cross-infection
may occur, additional barrier precautions
must be taken.
Acoustic
Safety
Continuous wave Doppler ultrasound
instruments such as the FD1+,FD2 & FD3
have been used extensively for medical
diagnosis in the United States for over 25
years. Throughout this period, there have
been no reports of adverse effects to
patients or instrument operators at the
acoustic intensities recommended for
diagnostic use. Despite this highly
favorable safety experience, available
data are not conclusive and the possibility
remains that unwanted biological effects
might be identified in the future.
Authorities therefore recommend that
ultrasound procedures be performed in
accordance with the "ALARA" principle,
which states that the energy delivered to
the patient should always be kept As Low
As Reasonably Achievable. With the
FD1+,FD2 & FD3, the transmitted
acoustic power is fixed and cannot be
adjusted by the operator. Therefore, the
user can best observe the ALARA
principle by ensuring that each
examination is medically indicated and by
limiting the duration of the study to the
extent appropriate for the clinical
objectives.
EENNGGLLIISSHH
((UUSSAA))
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