Luvion AngelSounds Guide De L'utilisateur page 2

ENGLISH - USER MANUAL
AngelSounds - fetal doppler
1. On/Off/volume slider
2. Power indicator light
3. Headphone socket(two)
4. Sensor
5. Battery compartment cover
Accessories
Introduction
The AngelSounds fetal doppler is a single-hand device
for detection of the fetal heart. The fetal heart may be
detected from early pregnancy, and more easily from
pregnancies greater than 12 weeks. Every AngelSounds
is supplied with a dry-cell battery. A dry-cell battery must
NOT be placed in a recharging device and must NOT be
disposed of by burning. The AngelSounds fetal doppler
operates at a nominal frequency of 3.3MHz, using Dop-
pler ultrasound. There is an 'on/off/volume key(1)' , it's easy
to operate. The LED working indicator light (2) shows
working condition. A headset and an audio line are avail-
able. The AngelSounds fetal doppler is lightweight and
designed to fit comfortably in your hand.
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All manuals and user guides at all-guides.com
Operation instruction
Insert the headset jack securely into the socket(3). Apply
a small amount of acoustic coupling gel to the examina-
tion site. Or put some gel on the top of the sensor (4).
Switching on On/Off/volume key (1)
This key is used to select either high or low volume level,
too. Hold the AngelSounds Fetal doppler. Plug in the
earphones.
The AngelSounds fetal doppler is now ready for use.
Operation
Place the transducer on the examination site and move
it around slowly until a good signal is obtained. This will
sound like 'galloping horses' . It may be necessary to angle
the transducer slightly to obtain the optimum signal.
Use of audio line
Insert one jack of the audio line into the main unit's
headset socket (any of the two), put another plug into the
recorder, then the fetal heart beat can be recorded by the
recorder. Move the transducer to the pregnant woman's
left chest to record her heart beat and play the mother's
heart beat to the baby. After the baby is born, this can
calm the baby down. To switch off, just turn the 'On/Off/
Volume Slider' .
Battery fitting or replacement
How to fit or replace the battery on the AngelSounds
fetal doppler:
Remove the rear battery compartment cover (5) carefully.
Remove the old battery. Fit the new battery (IEC6F22 9V
alkaline). Then close the battery cover.
• Use only the specified battery type and insert the
battery according to polarity instruction (check the
+ and – poles).
• Always dispose of empty batteries in accordance
with regulations. Do not dispose together with
household garbage.
New alkaline battery will give more than 500 one minute
examinations. Battery should be removed if the unit is
not in regular use. After use, the AngelSounds fetal dop-
pler should be dried thoroughly with a soft cloth.
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 qualified person-
nel to maintain safety, and reliability. Damage may
result if the AngelSounds Fetal doppler is knocked or
dropped.
Classification:
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 flam-
mable
Anaesthetic mixture with air or with oxygen or nitrous
oxide:
Do not use in the presence of flammable anaesthetics.
This detector is not explosion-proof and must not be
used in the presence of flammable 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 affect 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 specified, 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 confirmed adverse effects on patients or
instrument operators at the intensities typical of present
diagnostic instruments. Although the total absence of ad-
verse effects to human subjects after such extensive use
at diagnostic power levels is gratifying, available data are
not conclusive and the possibility that biological effects
may be identified in the future remains. It is therefore
deemed desirable by medical and other scientific authori-
ties in this field 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 effects by reason of pregnant
subjects be kept to a minimum. At present, there is a clear
consensus that the benefits 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 confirmation 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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