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Operating condition:
Do NOT leave the AngelSounds fetal doppler exposed to
direct sunlight.
Operating temperature: 0-40 °C
Operating humidity: 0% - 85%
Battery: IEC 6F22 9V alkaline
Safety check list:
The AngelSounds fetal doppler Fetal Heart Detector is
designed to comply with BS5724 part 1, IEC601-1,UL544
and other international medical safety standards for bat-
tery-operated (internally powered) medical equipment.
Warning
• Device is sealed and NOT user-serviceable. Device must
be serviced only by authorized and qualied person-
nel to maintain safety, and reliability. Damage may
result if the AngelSounds Fetal doppler is knocked or
dropped.
Classication:
Type of protection against electric shock: Internally
powered equipment.
Degree of protection against electric shock: Type B
Type B protection means that this equipment will comply
with:
EN 60601-1/ Medical Electrical Equipment Part 1:
IEC 60601-1 General Requirements for safety
EN 60601-1-2/ Standard for electromagnetic compat-
ibility
IEC 60601-1-2 requirements for medical electrical equip-
ment
U.S. Federal law restricts this device to use on or by the
order of a Physician. Degree of protection against harmful
ingress of water: Ordinary equipment Mode of operation:
design for continuous operation
Degree of safety of application in the presence of a am-
mable
Anaesthetic mixture with air or with oxygen or nitrous
oxide:
Do not use in the presence of ammable anaesthetics.
This detector is not explosion-proof and must not be
used in the presence of ammable anaesthetics.
Statement
The medical electrical equipment needs special precau-
tions
regarding EMC and needs to be installed and put into
service according to the EMC information provided in
the accompanying documents (this instruction). Portable
and mobile RF communications equipment can aect the
medical electrical equipment.
The equipment is without a manual sensitivity adjust-
ment, hence: The minimum amplitude or value of patient
physiological signal is 90dB.
Warning:
• Operation of the equipment or system below this am-
plitude or valuemay cause inaccurate results.
• The use of accessories, transducers and cables other
than those specied, with the exception of transducers
and cables sold by the manufacturer of the equipment
or system as replacement parts for internal compo-
nents, may result in increased emission or decreased.
Acoustic output data
The acoustic output of the AngelSounds fetal doppler
transducer has been measured in water using a calibrated
hydrophone at authorized Laboratory. Normalized values,
which estimate the maximum ‘in-situ’ dosage to tissue at
the point of highest intensity in the beam path have been
calculated. These data are presented in the following
tables.
Ultrasound safety considerations and data
General Diagnostic ultrasound has been in use for over
25 years with no conrmed adverse eects on patients or
instrument operators at the intensities typical of present
diagnostic instruments. Although the total absence of ad-
verse eects to human subjects after such extensive use
at diagnostic power levels is gratifying, available data are
not conclusive and the possibility that biological eects
may be identied in the future remains. It is therefore
deemed desirable by medical and other scientic authori-
ties in this eld that exposure to ultrasound should be
limited to the duration and intensity appropriate for the
clinical objective. Because fetal tissue could be more
sensitive to biological eects by reason of pregnant
subjects be kept to a minimum. At present, there is a clear
consensus that the benets to patients of prudent use of
diagnostic ultrasound outweigh the risks, if any, that may
be present.
AngelSounds fetal doppler is a portable battery operated
detector designed to detect fetal life and conrmation of
continued life during pregnancy. Minimizing patient ex-
posure Acoustic output of the AngelSounds fetal doppler
is internally controlled and cannot be changed by the op-
erator in the course of the examination. The duration is,
however, fully under the control of the operator. Mastery
of the techniques described in the operating instructions
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