Bedienungsanleitung Luvion AngelSounds (Seite 3 von 12) (Holländisch, Französisch)

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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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