Jumper AngelSounds JPD-100S User manual

Fetal Heart Detector
AngelSounds
INSTRUCTION MANUAL
JUMPER MEDICAL CO., LIMITED
JPD-100S
Accessories
Headset Recording cable
Controls and indicators
On/off/volume key
Working indicator light
Headset socket(two)
Transducer
Battery compartment cover
55
Jumper
Rev:20050407-001 A2005
I 2005/04/07ssue:
Print in China
CE Mark
01 02 03 04 05 06
07 08 09 10 11 12
2005 2006 2007 2008 2009 2010
Date of Manufacture
0197
Symbols
Warning
This CE markon a productdenotes conformity whit
the European CouncilDirective 93/42/EEC(MDD)
concerning medical devices
55
9595
%%
00
1515
++
6060
1010
CC
OO
500500
10601060
!!Caution, See instructions for use
Temperature:
from -10 to 60
Humidity:
from 0% to 95%
CC
OOCC
OO
Air Pressure:
from 500hpa to 1060hpa
Upward Water-proof
Non-hook Layer limit 15
Introduction
The AngelSounds JPD-100S 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 greaterthan 12 weeks.The AngelSoundsJPD-100S is
suitable for usein the antenatal.
Every AngelSounds JPD-100Sis supplied with 1dry-cell battery.
Dry-cell battery must NOT be placed in a re-charging device and must
NOT be disposedof by burning.
The AngelSounds JPD-100S operates at a nominal frequency of
3.3MHz,using Doppler ultrasound.
There has an 'on/off/volume key(1)', it's easy to operate. And working
indicator light (2)showsworking condition.
A headsetand an audioline are available.
The AngelSounds JPD-100S is lightweight and designed to fit
comfortably in hand.
Transport and storage conditions
--
Manufacturer
JUMPER MEDICAL CO.,LIMITED
http://www.jumper-medical.com
Add: 2nd Floor, No.5 Bldg., Nanshui Industry Village,
5th Industry Rd.,Shenzhen518067 P.R.China
Tel:[phone] Fax:[phone]
Device is sealedand NOT user-serviceable.
Device must be servicedby authorized and qualifiedpersonnel to
maintain safety,and reliability.
Damage may result if the AngelSounds JPD-100S is knocked or
dropped.
!!
Authorised representative in the european community:
Retail-therapy.com Limited
2 Hillside Cottages,Harley Lane,Heathfield,East Sussex,
TN21 8AQ

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 carriedout quarterly orannually, dependingon usage.
Check the AngelSounds JPD-100S for damage or cracks which may allow
the ingress ofliquids or gel.
Cleaning and disinfecting
Cleaning: Wipe the instrument case with a cloth dampened in soap or a
detergent solution andwipe dry witha clean cloth.
Disinfection: If soiled, cleanas above, then wipe the instrument case with
an alcohol-impregnated(70% ethanol orisopropyl).
Preventive maintenance
Operating condition:
Do NOT leavethe AngelSounds JPD-100Sexposed to direct sunlight.
Operating temperature :0-40 . R.H. :0%-85%
Battery: IEC 6F22 9V alkaline
Safety check list:
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.
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 compatibility
IEC 60601-1-2 requirements for medical electrical equipment
U.S. Federal lawrestricts this deviceto use onor by theorder 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 and needsto be installed andput into service accordingto
the EMC informationprovided in the ACCOMPANYINGDOCUMENTS (this
instruction).
Portable and mobile RFcommunications equipment can affect MEDICAL
EELECTRICAL EQUIPMENT.
The equipment iswithout a manual sensitivity adjustment, hence:
The minimum amplitudeor value of PAITIENT physiologicalsignal is
90dB
Warning:
Operation of theEUIPMENT or SYSTEMbelow this amplitudeor value
may cause inaccurate results.
Warning:
The use ofACCESSORIES, transducers and cables other than those
specified, with theexception of transducers and cables sold by the
manufacturer of theEQUIPMENT or SYSTEMas replacement partsfor
internal components, mayresult in increased EMISSION or decreased
The instrument is guaranteed for a period of 12 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
General
Diagnostic ultrasound has been in use for over 25years 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 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 ofdiagnostic ultrasound outweighthe risks, ifany, thatmay be
present.
AngelSounds JPD-100S is a portable battery operated detector designed
for the detection of fetal life and confirmation of continued life during
Ultrasound safety
considerations and data
Operation procedure
Insert the headset jacksecurely into the socket(3).
Apply a small amount of acoustic coupling gel to the examination site. Or
put some of gel,oil or water onthe top ofthe transducer(4).
Switching on On/off/volumekey(1)
'On/off/volume key(1)' isused to selecteither high orlow volume level,too.
Hold the AngelSoundsJPD-100S.
The AngelSounds JPD-100Sis now ready foruse .
Examination
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 audioline
Insert one jack of the audio line into the main unit's headset socket
(anyone of the two),put another plug intothe recorder, thenthe fetal heart
beat can berecord by recorder.
Move the transducer to 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 calmthe baby.
To switchoff turn 'on/off/volume key(1)' .
Battery fitting orreplacement
To fitor replace the batteryon the AngelSoundsJPD-100S:
Remove the rear battery compartment cover(5) carefully . Remove the old
battery. Fit the new battery (IEC6F22 9V alkaline). Then off the battery
cover.
·Use only the specifiedbattery type and insertthe battery according
to polarity instruction
·Always dispose ofempty batteries inaccordance
with regulations. Donot dispose together
with household garbage
New alkaline battery willgive more than 500one minute examinations.
Battery should beremoved if theunit is not in regular use.
After use, the Angelsounds JPD-100S should be dried thoroughly with a
soft cloth.
If Angelsounds JPD-100S is soiled after use, follow the cleaning, and
disinfection procedure detailedin the preventive maintenance section.
Pb Cd Hg
Technical specifications
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 theface of thetransducer
to the point ofmeasurement (cm)
then:
I =I exp.(-0.069f.z.)
TW
For example; at a 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
For technical data,please contact:
JUMPER MEDICAL CO.,LIMITED
http://www.jumper-medical.com
Add: 2nd Floor, No.5 Bldg., Nanshui Industry Village,
5th Industry Rd.,Shenzhen518067 P.R.China
Tel:[phone] Fax:[phone]
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. 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.
European Representative
Retail-therapy.com Limited
2 Hillside Cottages,Harley Lane,Heathfield,EastSussex,
TN21 8AQ