Warning:
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 components, may result in increased EMISSION or decreased
Ultrasound safety considerations and data
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 adverse effects to human subjects after such extensive use at diagnostic power levels is gratifying,
警告：
付属品や送受波器、ケーブルに関して、当社指定の交換部品以外のものをご利用になりますと、反応が過剰になったり、弱くなる可能性があります。
超音波の安全性について
超音波による診断は25年以上に渡って利用されており、一般的に使用される範囲では患者にも使用者にも悪影響は確認されていません。診断に使われるレベルの超音波では被験者に対して全く悪影響が見られなかったのは喜ばしいことなのですが、（次へ）
available data are not conclusive and the possibility that biological effects may be identifiedin the future remains.
It is therefore deemed desirable by medical and other scientific authorities 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 toa 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.
現在のデータも決定的なものとは言えず、将来、生体への影響が確認される可能性も残っています。
そのためこの分野の医者や科学者には、超音波にさらされる時間や強度は医学的目的に合わせて適度に制限されるべきであると考えられています。妊婦を被験者とした実験は極力避けられており、胎生組織が影響を受けやすい可能性は否定し切れません。
現在の一致した意見として、超音波による診断にリスクがあったとしても、患者が受ける恩恵はそれ以上に大きいと考えられています。
AngelSounds JPD-100S is a portable battery operated detector designed for the detection of fetal life and confirmation of continued life during pregnancy.
Minimizing patient exposure
Acoustic output of the AngelSounds JPD-100S is internally controlled and cannot changed by the operator in the course of the examination. The duration of sure is, however, fully under the control of the operator. Mastery of the techniques described in the operating instructions will facilitate limit the maximum amount of diagnostic information with the minimum of exposure.
Acoustic output data
The acoustic output of the AngelSounds JPD-100S transducer has been measured in water using a calibrated hydrophone at Authorized Laboratory.
AngelSounds JPD-100Sは胎児の存在と健康を確認できる、電池式で携帯可能な超音波検査器です。
超音波の使用を最低限に抑えるために
AngelSounds JPD-100Sで発信される音波は内部でコントロールされており、検査の途中で変更することはできません。ただし検査にかける時間は使用者が決めることができます。使用説明書に記載されている技術に慣れれば、超音波にさらされる時間を最低限に抑えながら、検査器としての性能を最大限に生かすことが容易になります。
音波データ
AngelSounds JPD-100Sから発信される音波は、権威ある研究所で、水中聴音器を使って水中で測定されています。
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 presentedin the following tables.
Table 1 Maximum acoustic output measured in water
Parameter of AngelSounds JPD-100S transducer
Operating mode Continuous Doppler
Frequency 3.3 MHz
Intended use Fetal heart detection
Intended for fetal use Yes
Control settings None
Acoustic intensity:
ISPTA (mW/cm ) <10mW/cm
Peak negative pressure <1 Mpa
Output beam intensity <20 mW/cm
ISPTA=Spatial peak, Temporal Average
Table 2 Estimation of maximum normalized 'in-situ'
Intensity in tissue estimate the 'in-situ' value in tissue at the point of examination, where:
IT=Spatial peak intensity 'in-situ' (tissue)
IW=Spatial peak intensity in water
F=Ultrasound frequency(MHz)
Z=Distance from the face of the transducer
to the point ofmeasurement (cm)
then:
IT=IW exp.(-0.069f.z.)
For example; at a typical point of measurement using the AngelSounds JPD-100S the following value of maximum intensity is obtained: Parameter of AngelSounds JPD-100S transducer
Typical measurement 4.8
Depth in tissue(cm)
Maximum intensity ISPTA 0.8
in tissue(mW/cm )
This also conforms tothe requirements of IEC1157 (details on request).
