Jumper AngelSounds JPD-100S User manual

JUMPER MEDICAL EQUIPMENT CO., LTD
6th Floor, No.6Bldg., Nanshui Industry Village,
5th Industry Rd., Shenzhen 518067 P.R.China
Fetal Heart Detector
JPD-100S
INSTRUCTION MANUAL
Manual Ver.: 1.0
Issuing Date: 2009/11/27

Product Information
Product Name: Fetal Heart Detector
Model: JPD-100S
Manufacturer: JUMPER MEDICAL EQUIPMENT CO., LTD
Add: 6th Floor, No.6 Bldg., Nanshui IndustryVillage,5th Industry
Rd.,Shenzhen 518067 P.R.China
Copyright
Copyright 2009.All rights reserved.
Statement
JumperMedical Equipment Co., Ltd owns the copyright ofthisnon-public
instruction book.
Without written authorization from Jumper Medical Equipment Co., Ltd,
any individual or organization shall not copy, modifyor translate this
book.
All contents described in this book are consistent with the actual situation
of the related product.
Jumper Medical Equipment Co., Ltd hasright torevise all contentsof this
book if needed, without prior notice.
Jumper Medical Equipment Co., Ltd reserves theright of final
interpretation of this book.
"JUMPER" and "ANGELSOUNDS"are the registered trademarks of
Jumper Medical Equipment Co., Ltd.

10
11
..9
..9
.1
.1
22
output
power
of
transmitter
W
150 kHz to 80
MHz
80 MHz to 800
MHz
800 MHz to 2,5
GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at amaximum output power not listed above, the
recommended separation distance d in metres (m)can beestimated
using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance forthe higher
frequency range applies.
NOTE 2 These guidelinesmay not apply in all situations.
Electromagnetic propagation is affected byabsorption and reflection
from structures, objects and people.
TABLE OF CONTENTS
SECTION 1: INTRODUCTION.........................................................................
1.1OVERVIEW.............................................................................................
1.2PRODUCTDESCRIPTION..........................................................................1
1.3OPERATINGPRINCIPLE............................................................................1
SECTION 2: SAFETYGUIDANCE......................................................................2
2.1INDICATIONSFORUSE............................................................................2
2.2CONTRAINDICATIONSFORUSE...............................................................2
2.3NOTEFORHOMEUSE.............................................................................2
2.4SAFETYTERMSANDCONDITIONS...........................................................2
2.5SAFETYALERTDESCRIPTIONS.................................................................3
2.6SYMBOLDESCRIPTIONS..........................................................................5
SECTION 3: USING THE PRODUCT.................................................................6
3.1UNPACKINGANDINSPECTING................................................................6
3.2SETTINGUPTHEPRODUCT.....................................................................7
3.3BUILDINBATTERY...................................................................................9
3.4OPERATEKNOBANDINDICATORLIGHT................................................
3.4.1 POWER ON....................................................................................9
3.4.2 POWER OFF.................................................................................
3.4.3 VOLUME ADJUSTMENT.................................................................9
3.4.4 AUDIO OUT.................................................................................10
3.5PREPARATION......................................................................................
3.6USINGPRODUCTTODETECT................................................................ 11
SECTION 4: MAINTENANCE & AFTER-SALES SERVICE.................................. 11
4.1MAINTENANCE.....................................................................................
4.2RECOMMENDEDMAINTENANCEANDCARE........................................12
4.3VISUALINSPECTION..............................................................................12
4.4CLEANINGPRODUCTANDACCESSORIES..............................................13
4.5CLEANINGINSTRUCTIONS....................................................................14
4.6DISINFECTIONS.....................................................................................15
4.7RECYCLINGTHEBATTERIES...................................................................15

18
4.8AUTHORIZEDREPAIRSERVICE..............................................................15
4.9CONTACTINFORMATION......................................................................15
SECTION 5: SPECIFICATIONS AND SAFETY...................................................16
5.1SPECIFICATIONS....................................................................................16
5.2MODEOFOPERATION..........................................................................17
5.3PHYSICALDIMENSIONS.........................................................................17
5.4ENVIRONMENTALREQUIREMENTS......................................................17
OPERATING CONDITIONS.....................................................................17
STORAGE AND SHIPPING CONDITIONS................................................
SECTION 6: ACCESSORIES............................................................................18
6.1OVERVIEW............................................................................................18
6.2PRODUCTACCESSORIES........................................................................18
APPENDIX A: EMC INFORMATION-GUIDANCE AND MANUFACTURE S
DECLARATION............................................................................................19
21
electromagnetic site survey, should
be less than the compliance level in
each frequency range.
b. Interference may occur in the
vicinity of equipment marked with
the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2These guidelinesmay not apply in all situations. Electromagnetic
propagation is affectedby absorption and reflection fromstructures,
objects and people.
a. Field strengthsfromfixed transmitters, such asbase stations forradio
(cellular/cordless) telephones and land mobile radios, amateur radio,AM
and FM radio broadcast and TV broadcast cannot bepredicted
theoretically withaccuracy. To assess theelectromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be
considered. If themeasured field strengthin thelocation inwhich the
Fetal Heart Detector isused exceeds theapplicableRF compliance level
above, the Fetal Heart Detector should be observed toverify normal
operation. If abnormal performanceis observed, additional measuresmay
be necessary, suchas re-orienting or relocating the Fetal Heart Detector.
bOver the frequency range 150kHz to80MHz, field strengths shouldbe
less than3 V/m.
Recommended separation distances between portable andmobile RF
communications equipment andthe Fetal Heart Detector.
The Fetal HeartDetector is intended for use in an electromagnetic
environment in which radiated RF disturbancesarecontrolled. The
customeror theuser of the Fetal HeartDetector can help prevent
electromagnetic interference by maintaining aminimum distance
between portable and mobile RFcommunications equipment
(transmitters)andthe Fetal HeartDetector as recommended below,
according to themaximum output power of the communications
equipment.
Rated
maximum Separation distance according to frequency of transmitter m

20
IEC
61000-4-2 air syntheticmaterial, the relative humidity should be
at least 30 %.
The Fetal HeartDetector is intended for use intheelectromagnetic
environment specified below. The customer orthe user ofthe Fetal Heart
Detector should assure that it is used in such an environment.
Immunity
test IEC 60601
test
level
Complia
nce
level
Electromagnetic environment
guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz
to 2,5
GHz
3 V/m Portable andmobile RF
communications equipment should
be used no closer to any part ofthe
Fetal Heart Detector including
cables, thanthe recommended
separation distance calculated from
the equation applicabletothe
frequencyof thetransmitter.
Recommended separation distance
a. WherePis themaximum output
power rating of the transmitterin
watts (W) according to the
transmitter manufacturerand dis
the recommended separation
distance in metres(m). Field
strengthsfromfixed RF
transmitters, as determined byan
1
SECTION 1: INTRODUCTION
1.1 OVERVIEW
Become familiar with the controls and how to use the product properly
before operating the product.
CAUTION: It should not be usedin life supporting or life
sustaining applications.
1.2 PRODUCT DESCRIPTION
The product is alightweight, portable detector. It is designed to meet
your detecting and hearing needsby providing advanced detecting
functionsand afull range of soundof the fetal heartbeat.
The product ismainly used todetect thesoundof thefetal heartbeat
(SFH).
The growth anddevelopment ofafetuscan befound out through
examination of these indices. It is applicable for departmentof
gynecology and obstetrics and clinic daily.
In accordance with classification criteria in Annex IX on “Medical Device
Directive93/42/EEC”,the product is class IIa based on rule 10, “Devices
for Direct Diagnosis or Detection onphysiological process”.
The product is powered by an internal battery.
1.3 OPERATINGPRINCIPLE
Fetal Heart Detector consists of probe (transmitterand receiver) and
signal process unit.
Ultrasonic wave is transmitted fromone piezoelectric ceramic at the front
of theprobe to theuterusof thepregnant women. Echo is received by
the otherpiezoelectric ceramic at the frontof the probe when ultrasonic

2
wave reaches thefatal heart. Then it is convertedinto voltage. This
Doppler signal isdetectedand demodulated fromthereceived signal.
And the Doppler frequency is consistent with the rhythm of the fetal
systole and diastole. Once cardiac valves vibrate andaDoppler
frequencyexcursion is formed. It is transmitted an output signal of
cardiac valves vibrating, and it issent tothe loudspeaker for gettinga
rhythmical sound with the fetal heartbeat.
SECTION 2: SAFETY GUIDANCE
2.1 INDICATIONS FOR USE
The product is normally applied to fetusabove 9~12 weeks growth,
difference in pregnant mater.
Listen to SFH:
Operator can listen tothesoundof fetal heartbeatfromthe
headset.
Audio record:
The sound of fetal heartbeat can be recorded by arecorder
which is connected with the product.
As asafety advisement that can only be connectedwith a
recordercomplied withthesafetyrequirements of IEC
60601-1.
2.2 CONTRAINDICATIONS FOR USE
Normallynone, as a particular case, please consult your doctor.
2.3 NOTE FOR HOME USE
Please consult your doctor.
2.4 SAFETY TERMS AND CONDITIONS
The signal words shown below, left, identify the potential hazard
categories. The definition of each categoryis as follows:
19
Appendix A: EMC Information-Guidance and Manufacture s
Declaration
CAUTION:
Fetal Heart Detector needs special precautions regarding EMC
and needs tobeinstalled and put into service according tothe
EMC information provided forin theACCOMPANYING
DOCUMENTS.
Portable and mobile RF communications equipment can affect
Fetal Heart Detector.
The Fetal HeartDetector should not beusedadjacent to or
stacked with other equipment.
The Fetal HeartDetector is intended for use in the electromagnetic
environment specified below. The customer or theuser of the Fetal heart
monitor should assure that it is used in such an environment.
Emissions test Compliance
RF
emissions
CISPR 11
Group 1 The Fetal HeartDetector usesRF energy
only for its internal function. Therefore, its
RF emissions are very low, and are not
likely to cause any interference innearby
electronic equipment.
RF
emissions
CISPR 11
Class BThe Fetal HeartDetector issuitable foruse
in all establishments, includingdomestic
establishmentsand thosedirectly
connectedto the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
The Fetal HeartDetector is intended for use in the electromagnetic
environment specified below. The customeror the user of theFetal Heart
Detector should assure that it is used in such an environment.
Immunitytest IEC
60601
test level
Compliance
level Electromagnetic environment guidance
Electrostatic
discharge
(ESD)
6 kV
contact
8 kV
6 kV
contact
8 kV air
Floors should be wood,
concreteorceramic tile. If
floors are covered with

18
STORAGE AND SHIPPING CONDITIONS
Temperature: -10°C to 55°C
Humidity: 10%- 95% RH, non-condensing
Atmospheric pressure: 50kPa to 106kPa
CAUTION: Environment of use
Product is designed for indoor use.Operator mustconfirm that
the environment of usemeets the required operating
environmental specifications before using.
CAUTION: Cold Environments
If the Product is storedin an environment with atemperature
below the operating temperature,the unit should be allowedto
warm upto the needed operating temperature before using.
SECTION 6: ACCESSORIES
6.1 OVERVIEW
This section contains alist of partsand software accessories for Product.
To place an order, contact your representative or distributor.
6.2 PRODUCT ACCESSORIES
Product isavailable in more thantwenty languages, with others being
added onaregular basis. For acomplete list ofthose available, contact
your sales representativeor Jumper Medical Equipment Co., Limited
Customer Service.
ACCESSORIES
Part Number Description
JP100S-HS13B Headset Φ3.5mm
JP100S-RC1.2M Recording cable Φ3.5mm
3
DANGER: This alert identifies hazards that will causeserious
personal injury ordeath.
WARNING: This alert identifies hazardsthat may cause
serious personal injury or death.
CAUTION: This alert identifies hazards that may cause minor
personal injury, product damage, or property damage.
2.5 SAFETY ALERT DESCRIPTIONS
The following is alist of product safety alerts that appear in this section
and throughout this manual. Youmustread, understand, and payheed
to these safety alerts before attempting tooperate the product.
DANGER: Fire and Explosion Hazard
Do not operate the Product in thepresence of flammable
gases toavoid possible explosion or fire hazard.
CAUTION: Temperature/Humidity/Pressure Extremes
Exposingthe Product toextremeenvironmental conditions
outside of its operating parameters maycompromise the
ability of the Product tofunction properly.
CAUTION: Battery Disposal
Recycleordispose of the battery in accordance with all
federal, state andlocal laws. To avoid fire and explosion
hazard, do not burn orincinerate the battery.
WARNING: Use only Approved Equipment
Do not use batteries, gel, cables, or optionalequipment other
than those approved by Jumper Medical Equipment
Co.,Limited which maycausetheproduct to function
improperly during a rescue.
CAUTION: Possible Radio Frequency (RF) Susceptibility
RF susceptibilityfromcellular phones, CB radios and FM
2-way radio may cause interferencewith theproduct. Donot
operatewireless radiotelephones in thevicinity of the Product
turn power OFF totheradiotelephone andotherlike
equipment nearthe Product.

4
WARNING: Adjacent and/or Stacked Equipment
The Product should not beusedadjacent to orstacked with
other equipment. If adjacent orstacked use is necessary,
the Product should beobserved toverify normal operation in
the configuration in which it will be used.
CAUTION: Systems Statement
Equipment connected to the product mustbe certified tothe
respective IECStandards (i.e. IEC 950for dataprocessing
equipment andIEC 601-1 for medical equipment).
Furthermore, all configurations shall comply with thesystem
standardIEC 601-1-1. Anybody who connects additional
equipment to thesignal input part orsignal output part
configures amedical system, andis therefore, responsible
that thesystemcomplies with therequirements ofthe system
standardIEC 601-1-1. The product service portis only
intended for useduring maintenance by authorized service
personnel.
CAUTION: Case CleaningSolutions
When disinfecting thecase, useanon-oxidizing disinfectant,
such as ammonium saltsor glutaraldehyde basedcleaning
solution, to avoid damage to the metal connectors.
CAUTION: Environment of use
The product is designed forindoor use.Operator must
confirm that the environment of use meets therequired
operating environmental specifications before using.
CAUTION: Cold Environments
If the product is stored in an environment with atemperature
below the operating temperature,the unit should be allowed
to warmup to the needed operating temperaturebefore
using.
17
Overall sensitivity at the distances
200mm from the face of the transducer
（Doppler frequency:300±50Hz,Targe
velocity: 10cm/s~40cm/s）
≥90dB
Spatial-peak temporal-peak acoustic
pressure: <8.6kPa
Output power: <26mW
Effectivearea of the ultrasonic
transducer active element: 5.3cm2±20%
The acoustic coupling medium for
normal use: ph :5.5~8, Acoustic impedance:
1.5*106~1.7*106Pa·s/m
AUDIO OUTPUT
Audio Output Power: <0.2 W
Audio out socket: Φ3.5mm
BATTERY
Battery Voltage: 9V
Type: IEC6F22 9V alkaline
5.2 MODE OF OPERATION
Continuous operating
5.3 PHYSICAL DIMENSIONS
104mm (W) x 120mm (D) x 61mm(H), Wt: 0.14kg (including battery)
W 4.1in, D 4.7in, H 2.4in, Wt: 31lbs (including battery)
5.4 ENVIRONMENTAL REQUIREMENTS
OPERATING CONDITIONS
Temperature: 5°C to 40°C
Humidity:<80%RH, non-condensing
Atmospheric pressure: 86kPa to 106kPa

16
Authorized European Representative:
SECTION 5: SPECIFICATIONS AND SAFETY
This section presents the specifications andsafetystandards of the
Product.
5.1 SPECIFICATIONS
NOTE: The following specifications are subject tochange and
are only noted asa point of reference.
ULTRASOUND
Ultrasonic emitting frequency: 3MHz
Ultrasonic emitting power: <10mW/cm2
Jumper Medical Equipment Co., Limited
6th Floor, No.6Bldg., Nanshui IndustryVillage,
5th Industry Road., Shenzhen Guangdong 518067 P.R.
China
Tel:[phone] Fax:[phone]
Web site: http://www.jumper-medical.com
Wellkang Ltd
Suite B, 29Harley Street, LONDON,
W1G9QR,U.K.
5
2.6 SYMBOL DESCRIPTIONS
The following symbols may appear inthismanual, ontheproduct, oron
its accessories. Someof thesymbolsrepresent standards and
compliances associated with the product and its use.
Consult instructions for useof the product and/or
its accessories.
Warning Information
Authorized Representative in the European
Community
CE Mark: The Product systemconforms to
essential requirements oftheMedical Device
Directive93/42/EEC.
Date of manufacture.
Manufacturer
Storage Temperature
Humidity
Atmospheric Pressure

6
Upward
Non-hook
Specifiesserial number of the Product
Batch code
Itindicatesthat theequipment shouldbe sent to the
special agenciesaccordingtolocalregulation for
separate collection after its useful life.
SECTION 3: USING THE PRODUCT
This section provides thedescription foroperation.
3.1 UNPACKINGAND INSPECTING
Every attempt ismade to ensure your accurate and complete order.
However,to besure thatyour correct order,verifyingthe contents ofthe
box against yourpacking slip.
The product is designed for simplicity of operation and set-up and
requires minimal assembly. The following items areincluded in your
box:
1 (one)Product
1 (one)Headset
1 (one)Recording Cable
1 (one)Operator’s manual
15
* Don’t use strong solvent, for example, Acetone.
* Never use an abrasive such as steel wool or metal polish.
*Do not allow any liquidto enterthe product, anddo not immerseany
parts of the device into and liquids.
* Avoid pouring liquids on the device while cleaning.
* Don’t remain any cleaning solution on the surface of the device.
Wipe thesurface of sensorof transducer with 70% ethanol or alcohol,
self-air dry or clean with aclean, dry cloth.
4.6 DISINFECTIONS
Cleaningtheunit surfaceand the transducer astheabovementioned,
then wipe the surface of transducer with 70%ethanol or alcohol, clean
the transducer surface with a dry, soft cloth.
* Don’t use low temperature steamsterilization or other way tosterilize.
* Don’t use high temperature sterilizing process.
4.7 RECYCLING THE BATTERIES
The batteries arerecyclable. Remove theold battery fromthe Product
and follow your local recycling guidelines or Refer tolocal regulations.
WARNING: Irregular treatment ofbatteriesmay beresult in
hazards to healthand environment.
4.8 AUTHORIZED REPAIR SERVICE
The Product has no user-serviceable internal components. Try to resolve
any maintenanceissues with theProduct by usingtheTroubleshooting
Table presented in this chapter. If you are unable to resolve the problem,
contact Jumper Medical Equipment Co., Limited Service department.
NOTE: The warranty will be void upon unauthorized disassembly
or service of the product.
4.9 CONTACT INFORMATION
Product is manufactured by: