AngelSounds - Baby monitor Luvion - Free user manual and instructions

USER MANUAL AngelSounds Luvion

3. Headphone socket(two)

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/o/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 t comfortably in your hand. 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/O/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 o, just turn the ‘On/O/ Volume Slider’. Battery tting or replacement How to t 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 specied 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. 2Operating 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 qualied person- nel to maintain safety, and reliability. Damage may result if the AngelSounds Fetal doppler is knocked or dropped. Classication: 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 aect 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.

• 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 specied, 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 conrmed adverse eects on patients or instrument operators at the intensities typical of present diagnostic instruments. Although the total absence of ad- verse eects to human subjects after such extensive use at diagnostic power levels is gratifying, available data are not conclusive and the possibility that biological eects may be identied in the future remains. It is therefore deemed desirable by medical and other scientic 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 eects by reason of pregnant subjects be kept to a minimum. At present, there is a clear consensus that the benets 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 conrmation 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 3will facilitate limit the maximum amount of diagnostic information with the minimum of exposure. table 1. Maximum acoustic output measured in water (Parameters of Angelsounds fetal doppler Transducer) Operating mode Continuous Doppler Frequency 3.3 MHz Intended use Fetal heart detection Intended for fetal use Yes Control settings None Acoustic intensity I *(mW/cm2) < 10mW/cm2 SPTA Peak negative pressure < 1 Mpa Output beam intensity < 20 mW/cm2 *I =spatial peak, temporal average Intensity in tissue estimate the ‘in-situ’ value in tissue at the point of examination, where: I =Spatial peak intensity ‘in-situ’ (tissue) T I =Spatial peak intensity in water W F=Ultrasound frequency(MHz) Z=Distance from the face of the transducer to the point of measurement (cm) then: I =I exp.(-0.069f.z.) T W For example; at a typical point of measurement using the AngelSounds fetal doppler the following value of maximum intensity is obtained: Parameter of AngelSounds fetal doppler transducer Typical measurement 4.8 Depth in tissue(cm) Maximum intensity I 0.8 SPTA in tissue(mW/cm2) This also conforms to the requirements of IEC1157 (de- tails on request). If you have questions, please contact: Luvion, Kleveringweg 25, 2616LZ Delft, the Nether- lands, [e-mail], www.luvion.com Transport and storage conditions Temperature: from -10C° to 60 C° Air pressure: from 500hpa to 1060hpa Humidity: from 0% to 95% Use no hooks General information This CE mark on a product denotes conformity with the European council directive 93/42/EEC(MDD) concerning medical devices European Representative: Wellkang Ltd. Suite B, 29 Harley Street, London, W1G9QR, UK PZN: 2686378 Manufacturer: Shenzen Jumper Medical Equiment Co. Ltd Made in China General Importeur: Egerium B.V. Kleveringweg 25 2616 LZ Delft the Netherlands