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 intensityin water
W
F=Ultrasound frequency(MHz)
Z=Distance from theface of thetransducer
to the point ofmeasurement (cm)
then:
I =I exp.(-0.069f.z.)
TW
For example; ata typical point of measurement using the AngelSounds
JPD-100S the followingvalue of maximumintensity is obtained:
Parameter ofAngelSounds JPD-100S transducer
Typical measurement 4.8
Depth in tissue(cm)
Maximum intensity I 0.8
SPTA
2
in tissue(mW/cm )
This also conforms tothe requirements of IEC1157 (details on request).
Table 2 Estimation of maximum
normalized 'in-situ'
Table 1 Maximum acoustic output
measured in water
Parameter ofAngelSounds JPD-100S transducer
Operating mode ContinuousDoppler
Frequency 3.3 MHz
Intended use Fetalheart detection
Intended for fetaluse Yes
Control settings None
Acoustic intensity:
*2 2
I (mW/cm ) 10mW/cm
SPTA
Peak negative pressure 1 Mpa
2
Output beam intensity 20 mW/cm
*I =Spatial peak, Temporal Average
SPTA
prudent use of diagnostic ultrasound outweigh the risks, if any, that
may be present.
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 ofsure 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. Normalized values, which estimate the maximum 'in-situ'
dosage to tissue atthe point of highestintensity in the beam path have
been calculated.
These data are presentedin the following tables.
Operating condition:
Do NOT leavethe AngelSounds JPD-100Sexposed to direct sunlight.
Operating temperature :0-40 . R.H. :0%-85%
Battery: IEC 6F22 9V alkaline
General
The equipment is designed to require a minimum amount of
maintenance. To obtain the best performance and maintain safety, the
following checks should be carried out quarterly or annually,
depending on usage.
Check the AngelSounds JPD-100S for damage or cracks which may
allow the ingressof liquids or gel.
Cleaning and disinfecting
Cleaning: Wipe the instrument case with a cloth dampened in soap or
a detergent solutionand wipe dry with a clean cloth.
Disinfection: If soiled, clean as above, then wipe the instrument case
with an alcohol-impregnated(70% ethanolor isopropyl).
Preventive maintenance
The instrument is guaranteed for a period of12 months from the date
of purchase against defects in materials or workmanship. Any
AngelSounds JPD-100S which is proven to be defective within this
period shall, at Jumper Medical Co., Limited, be either repaired or
replaced free of charge,providing that:
1The AngelSounds JPD-100S has not been damaged by misuse,
mishandling or attemptedrepair.
2The AngelSounds JPD-100S is returned to Jumper Medical Co.,
Limited, carriage paid.
Guarantee
Technical specifications
Symbols
Transport andstorage conditions
9595
%%
00
++
6060
1010
CC
OO
500500
10601060
Temperature:
from -10 to 60
Humidity:
from 0% to 95%
C
OC
O
Air Pressure:
from 500hpa to 1060hpa
Upward Water-proof
Non-hook
1515
Layer limit 15
--
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, 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 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 byreason of pregnant subjectsbe kept to aminimum.
At present, there is a clear consensus that the benefits to patients of
Ultrasound safety
considerations and data
Safety check list:
Classification:
The AngelSounds JPD-100S Fetal Heart Detector is designed to
comply with BS5724 part 1, IEC601-1,UL544 and other international
medical safety standards for battery-operated (internally powered)
medical equipment.
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 compatibility
IEC 60601-1-2 requirements for medical electrical equipment
U.S. Federal lawrestricts this deviceto 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 FLAMMABLE
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 DELECTRICALEQUIPMENT needs special
precautions regarding EMC andneeds to be installedand put into
service according tothe EMC information provided in the
ACCOMPANYING DOCUMENTS(this instruction).
Portable and mobile RFcommunications equipment can affect
MEDICAL EELECTRICALEQUIPMENT.
The equipment iswithout a manual sensitivity adjustment, hence:
The minimum amplitudeor value of PAITIENT physiologicalsignal is
90dB
Warning:
Operation of theEUIPMENT or SYSTEMbelow this amplitude or value
may cause inaccurate results.
Warning:
The use ofACCESSORIES, transducers and cablesother than those
specified, with theexception of transducers and cables sold by the
manufacturer of theEQUIPMENT or SYSTEMas replacement parts for
internal components, mayresult in increased EMISSION or decreased
IMMUNITY of theEQUIPMENT or SYSTEM.
AngelSounds
