Grafco GRAFCO 14423-2 User manual

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ULTRASOUND POCKET DOPPLER
USER MANUAL
14423-INS-LAB-RevD11
Important: Do not use the Pocket Doppler
without rst reading and understanding this
manual! Save this manual for future use.
FederalLaw(USA)restrictsthisdevicetosale
byorontheorderofaphysician.Thisproduct
shouldnotbeusedunlesstheoperatorhas
beeninstructedbyaqualiedhealthcarepro-
fessional.

14423-INS-LAB-RevD11 2
CONTENTS
1 INTRODUCTION.........................................................................3
INTENDEDUSEOFTHISDEVICE........................................3
INCLUDEDFEATURES..........................................................3
OPTIONALACCESSORIES...................................................4
2 SAFETYINFORMATION..............................................................5
SAFETYPRECAUTIONS.......................................................5
SYMBOLS.............................................................................9
3 HANDLING................................................................................10
GFHEALTHPRODUCTS,INC.FREIGHTPOLICY...............10
UNPACKING.......................................................................10
STORAGE...........................................................................11
4 ULTRASOUNDPOCKETDOPPLERANDACCESSORIES..........12
APPEARANCEANDFEATURES..........................................12
POCKETDOPPLERWATER-RESISTANTPROBES..............17
BATTERY............................................................................17
5 SETUP......................................................................................18
INSTALLINGORREPLACINGTHEBATTERY.....................18
6 OPERATION..............................................................................20
PROBEOPERATION...........................................................20
TURNINGONTHEPOCKETDOPPLER..............................21
FETALHEART(FH)MONITORING......................................22
VASCULARMONITORINGWITH4.0OR8.0MHZPROBE
(OPTIONAL)..................................................................23
TURNINGOFFTHEPOCKETDOPPLER.............................24
REPLACINGTHEBATTERY................................................24
7 MAINTENANCE.........................................................................25
MAINTENANCE...................................................................25
CLEANING..........................................................................26
DISINFECTION...................................................................28
8 SPECIFICATIONS.....................................................................29
9 LIMITEDWARRANTY...............................................................32
10 APPENDIXA,ECDECLARATIONOFCONFORMITY................35
11 APPENDIXB,EMCINFORMATION...........................................36
GUIDANCEANDMANUFACTURER’SDECLARATION.........36
12 APPENDIXC,OVERALLSENSITIVITY......................................... 40
13 INDEX.......................................................................................42
Graham-Field and Grafco are registered trademarks of
GF Health Products, Inc.
Packaging, warranties, products, and specications are subject to
change without notice. GF Health Products, Inc. is not responsible for
typographical errors.

14423-INS-LAB-RevD11 3
1 INTRODUCTION
This user manual contains important information and
safety precautions for the Grafco Ultrasound Pocket Dop-
pler. Before using the Pocket Doppler, please read and
understand this entire user manual. Take special note of all
safety precautions that begin “WARNING” and “CAUTION”.
Save this user manual for future reference.
Info: The most current version of this manual can be
found at www.grahamfield.com
INTENDEDUSEOFTHISDEVICE
The Grafco Ultrasound Pocket Doppler is intended for
clinical use as an obstetrical evaluation tool. The Grafco
Ultrasound Pocket Doppler may also be used for optional
vascular monitoring. The Pocket Doppler is not intended
to be used for treatment or diagnosis. Use the Pocket Dop-
pler only as prescribed by a physician.
WARNING:Thisdeviceisnotintendedtobeused
fortreatmentordiagnosis.IfPocketDopplerresults
areambiguous,pleaseuseothermethods,suchasa
stethoscope,toverifyimmediately.
WARNING:Toensurepatientsafety,usethisdevice
onlywithaccessoriesrecommendedbyGFHealth
Products,Inc.,yourGFauthorizeddistributor,oryour
physician.
INCLUDEDFEATURES
Mini USB Probe Socket
Probe Detector
Built-in Speaker
Adjustable Volume
Alkaline Battery (9V)
Low Battery Detector / Indicator
Obstetrical or Vascular Monitoring

14423-INS-LAB-RevD11 4
OPTIONALACCESSORIES
The following accessories for use with the Grafco Ultrason-
ic Pocket Doppler are available from your GF Health Prod-
ucts, Inc. authorized distributor or www.grahameld.com.
ItemNo. ProductDescription
4001GF Coupling Gel, case of 12 0.25 liter bottles
4002GF Coupling Gel, 5 liter bottle
14423-2P 2.0 MHz Water-Resistant Probe
14423-4P 4.0 MHz Water-Resistant Vascular Probe
14423-8P 8.0 MHz Water-Resistant Vascular Probe

14423-INS-LAB-RevD11 5
2 SAFETYINFORMATION
SafetyGuidance
This unit has internally
powered equipment,
and the degree of shock
protection is type B
Type B protection means that this
product is in accordance with
permitted leakage currents and
dielectric strengths of IEC 60601-1.
SAFETYPRECAUTIONS
The safety statements presented in this chapter refer
to the basic safety information that the operator of the
Pocket Doppler shall pay attention to and abide by. There
are additional safety statements in other chapters or sec-
tions, which may be the same as or similar to the follow-
ing, or specic to the operations. WARNING and CAUTION
statements must be observed. To avoid the possibility of
injury, observe the following precautions during the opera-
tion of the instrument.
Please note the following special statements, used through-
out this manual, and their signicance:
WARNING:Indicatesapotentialhazardsituationor
unsafepracticethat,ifnotavoided,couldresultin
deathorseriouspersonalinjury.
CAUTION:Indicatesapotentialhazardorunsafe
practicethat,ifnotavoided,couldresultinmoderate
orminorpersonalinjury.
s NOTICE:Indicatesapotentialhazardorunsafeprac-
ticethat,ifnotavoided,couldresultinproductor
propertydamage.
Info: Provides application recommendations or other
useful information to ensure that you get the most from
your product.

14423-INS-LAB-RevD11 6
WARNINGS
WARNING:FederalLaw(USA)restrictsthisdeviceto
salebyorontheorderofaphysician.Thisproduct
shouldnotbeusedunlesstheoperatorhasbeenin-
structedbyaqualiedhealthcareprofessional.
WARNING:DonotusetheGrafcoPocketDopplerina
ammableatmospherewhereconcentrationsofam-
mableanestheticsorothermaterialsmayoccur.
WARNING:Donotexposebatteriestoheat.
WARNING:Donotattempttochargealkalinebatter-
ies;theymayleakorcatchonre.
WARNING:DONOTsimultaneouslytouchsignalin-
putoroutputconnectorandthepatient.
WARNING:Accessoryequipmentconnectedtothe
analoganddigitalinterfacesmustbecertiedaccord-
ingtotherespectiveIECstandards(e.g.IEC950for
dataprocessingequipmentandIEC60601-1formedi-
calequipment).Furthermoreallcongurationsshall
complywiththevalidversionofthesystemstan-
dardIEC60601-1-1.Anyonewhoconnectsadditional
equipmenttothesignalinputconnectororsignal
outputconnectorconguresamedicalsystem,andis
thereforeresponsiblethatthesystemcomplieswith
therequirementsofthevalidversionofthesystem
standardIEC60601-1-1.Ifindoubt,consultyourGF
HealthProducts,Inc.authorizeddistributor.
WARNING:TheGrafcoPocketDopplerisatooltoaid
thehealthcareprofessionalandshouldnotbeusedin
placeofnormalfetalmonitoring.
WARNING:Exposuretoultrasoundshouldbekeptas
lowasreasonablyachievable.Thisisconsideredto
begoodpracticeandshouldbeobservedatalltimes.
WARNING:Replacethebatteryatleast6feet(1.5me-
ters)fromthepatient.

14423-INS-LAB-RevD11 7
WARNING:DonottheusePocketDopplerifthebat-
terycoverisopen.
WARNING:UseonlythoseprobesprovidedbyGF
HealthProducts,Inc.intendedtobeusedwiththe
GrafcoPocketDoppler.
WARNING:Donotstretchtheprobecablefurther
than6.5feet(2meters).
WARNING:ElectromagneticInterference:Beforeop-
eration,ensurethattheenvironmentinwhichthede-
viceisoperatedisnotsubjecttoanysourceofstrong
electromagneticinterference,suchasradiotransmit-
ters,mobiletelephones,etc.
WARNING:Thefollowingsafetychecks/testsmustbe
performedatleastonceeverytwoyearsorasspeci-
edinyourfacility'stestandinspectionprotocol,by
aqualiedpersonwithadequatetraining,knowledge,
andpracticalexperience:
• Inspecttheequipmentformechanicalandfunc-
tionaldamage.
• Ensurethesafetylabelsarelegible.
• Verifythatthedevicefunctionsproperlyasde-
scribedinthismanual.
• Testaccordingtothepregnantwoman'sleakage
current(IEC60601-1/1988:Limit:100uA(B)).
 Theleakagecurrentshouldneverexceedthespeci-
edlimit.RecordthedataandstorewiththeGrafco
PocketDoppler.Ifthedeviceisnotfunctioningprop-
erlyorfailsanyoftheabovetests,contactGFHealth
Products,Inc.TechnicalSupportatthephonenumber
onthebackcover,oryourGFauthorizeddistributor.

14423-INS-LAB-RevD11 8
NOTICES
s NOTICE:ThemainunitoftheGrafcoPocketDoppler
isdesignedforcontinuousnormaloperation.Donot
immerseorsubmergeinanyliquid.
s NOTICE:KeepthePocketDoppleranditsenviron-
mentcleananddust-free.Protectthedevicefromvi-
bration,corrosivemedicine,andhightemperatures.
s NOTICE:Donotusehigh-temperaturesterilizingpro-
cess,lowtemperaturesteam,E-beam,orgammara-
diationsterilizationonthisdeviceoritsaccessories.
s NOTICE:IfthePocketDopplerwillnotbeusedfora
prolongedperiodoftime,removethebatteryfromthe
device.
s NOTICE:Keepthebatteryawayfromobjectsormate-
rialswithstaticelectriccharges.
s NOTICE:Ifthebatteryterminalsbecomedirty,wipe
themwithaclean,dryclothbeforeusingthebattery.
s NOTICE:Batterieshavelifecycles.Ifthebatteryuse
timeshortensnoticeably,thebattery'slifecycleis
over.Replacetheoldbatterywithanewoneofthe
samesizeandtype.Useonlybatteriesrecommended
byGFHealthProducts,Inc.
s NOTICE:Removeabatterywhoselifecycleisover
fromthemonitorimmediately.
s NOTICE:Forinformationoninstallingandremoving
thebatteryfromthemonitor,seeSection5,SETUP.
s NOTICE:Disposeofthebatteryinaccordancewithlo-
calregulations.
s NOTICE:Donotdisposeofthisdevicewithhouse-
holdwaste.Disposeofthisdeviceinaccordancewith
yourlocallawsandregulations.

14423-INS-LAB-RevD11 9
SYMBOLS
Attention: Refer to accompanying documents (this manual).
This item is compliant with Medical Device Directive 93/42/
EEC of June 14, 1993, a directive of the European Economic
Community.
This symbol consisting of two parts, see below.
Indicates that the equipment should be disposed of according
to local regulation for separate collection after its useful life.
Do not dispose of this device with household waste.
Indicates that the equipment is put on the market after 13
August 2005.

14423-INS-LAB-RevD11 10
3 HANDLING
GFHEALTHPRODUCTS,INC.FREIGHTPOLICY
Foryourprotection,readcarefully
The carrier accepted this merchandise “in good condition”
and is responsible for safe delivery. Before signing the
freight bill, inspect the shipment carefully for damage or
missing pieces.
Apparentlossordamage
Should visual inspection show loss or damage, this MUST
be noted on the freight bill and signed by the carrier's
agent. Failure to do so may result in the carrier failing to
honor the claim. Please contact the carrier to obtain the
paperwork necessary to le a claim or contact GF Health
Products, Inc. Customer Service at the number on the back
cover of this manual.
Concealedlossordamage
If damage is discovered after delivery is made, a concealed
damage claim must be entered with the freight carrier.
When this occurs, make a written request to the carrier for
inspection. This request for inspection must be made with-
in 15 days of delivery. The carrier will provide all paper-
work necessary to le a concealed damage or loss claim,
since such damage or loss is the carrier's responsibility.
UNPACKING
Info: Unless the Pocket Doppler is to be used immediately,
retain containers and packing materials for storage until
Pocket Doppler use is required.
1. Check for obvious damage to the carton or its contents.
If damage is evident, please notify the carrier and your
GF Health Products, Inc. authorized distributor.
2. Remove all loose packing from the carton.
3. Carefully remove all the components from the carton.

14423-INS-LAB-RevD11 11
Inspection
Check the Pocket Doppler for nicks, dents, scratches, me-
chanical or other damage. Check all the cables and acces-
sories.
STORAGE
Store the repackaged Pocket Doppler in a dry area.
s NOTICE:EnsurethatthetemperatureatthePocket
Doppler'slocationduringstoragedoesnotfallbelow
~14°F(-10°C)orexceed~131°F(55°C).
s NOTICE:EnsurethatrelativehumidityatthePocket
Doppler'slocationduringstoragedoesnotexceed
93%.

14423-INS-LAB-RevD11 12
4 ULTRASOUNDPOCKETDOPPLER
ANDACCESSORIES
APPEARANCEANDFEATURES
The following gures illustrate the Pocket Doppler with the
2.0 MHz water-resistant probe, and accompanying tables
describe labeled features.
FrontPanel
Feature Function
Display
Panel
Displays system info
System status
LED
The system status LED is at the left bottom
corner of the display panel. Please see
the following table for signicance of LED
indicators.
LED
Illumination
Color
LED
Illumination
Condition
Signicance
Green Constant Power on
Flashing Probe disconnected or not
properly connected
Orange Flashing
Battery too low for
operation; replace battery
immediately
Brand
Brand of Pocket Doppler
Probe
The Probe is used to perform ultrasound monitoring
Speaker
The built-in speaker makes the fetal sounds audible

14423-INS-LAB-RevD11 13
Power
Button
Turns the Ultrasound Pocket Doppler ON or
OFF
Probe
Socket
The probe connects here to the Ultrasound Pocket Doppler
Jack Denition
1 Power Supply
2 Signal
3 Probe Coding 1
4 Probe Coding 2
5 Probe Coding 3
6 (Shell) GND

14423-INS-LAB-RevD11 14
RearPanel
Feature Function
PocketClip
Attachment
Attaches Pocket Doppler to pocket
Battery
Compartment
Opens to install/replace battery
ProbeFrame
Attaches probe to Pocket Doppler

14423-INS-LAB-RevD11 15
TopPanel
Feature Function
Socket Name Picture Function
Charge
Socket Not used
Earphone
Socket Connect earphone
Signal
Interface 1 GND
2 Signal
3 Signal
4 Signal
5 Signal
Warning
Refer to accompanying documents
(this user manual)
 WARNING:Accessoryequipmentconnectedtothe
analoganddigitalinterfacesmustbecertiedaccord-
ingtotherespectiveIECstandards(e.g.IEC950for
dataprocessingequipmentandIEC60601-1formedi-
calequipment).Furthermoreallcongurationsshall
complywiththevalidversionofthesystemstan-
dardIEC60601-1-1.Anyonewhoconnectsadditional
equipmenttothesignalinputconnectororsignal
outputconnectorconguresamedicalsystem,andis
thereforeresponsiblethatthesystemcomplieswith
therequirementsofthevalidversionofthesystem
standardIEC60601-1-1.Ifindoubt,consultyourGF
HealthProducts,Inc.authorizeddistributor.

14423-INS-LAB-RevD11 16
LeftPanel
Feature Function
VolumeControl
Adjust
volume Increase volume: Rotate volume knob
clockwise
Decrease volume:
Rotate volume knob
counter-clockwise
MODEButton
Not used
START/STOPButton
REC/PLAYButton

14423-INS-LAB-RevD11 17
POCKETDOPPLERWATER-RESISTANTPROBES
The 2.0 MHz, 4.0 MHz, and 8.0 MHz water-resistant probes
connect to the main unit of the Grafco Pocket Doppler via
the probe socket. The following table lists and describes
the main information on each probe's label in order of ap-
pearance:
PocketDopplerWater-ResistantProbeLabelTable
PictureofProbe
ProbeLabel
Text
2.0MHz
Water-Resistant 
Probe
4.0MHz
Water-Resistant 
Vascular
Probe*
8.0MHz
Water-Resistant 
Vascular
Probe*
CD
Continuous Wave Doppler
X.0(Central
Frequency)
Central
frequency =
2.0 MHz
Central
frequency =
4.0 MHz
Central
frequency =
8.0 MHz
A
Probe version number
SNxxxxx:
Probe Serial Number
Water-Resistant
The probe is water-resistant
IPX8
( Water-Resistant )
Water Ingress Protection Code, which indicates
this probe can work continuously for 5 hours when
immersed in water up to one meter deep.
* Vascular probes are used to monitor arteries and veins
BATTERY
See Section 5, SETUP, for battery installation and replace-
ment instructions.
WARNING:Useonly9Valkalinebatteries(IECType
No.6LR61/6LF22orequivalent)inthisdevice.

14423-INS-LAB-RevD11 18
5 SETUP
INSTALLINGORREPLACINGTHEBATTERY
WARNING:EnsurethatPocketDopplerpowerisoff
beforereplacingthebattery.
WARNING:Install/replacethebatteryatleast6feet
(1.5meters)fromthepatient.
WARNING:Useonly9Valkalinebatteries(IECType
No.6LR61/6LF22orequivalent)inthisdevice.
batteryinstallation
batterysocket
batteryconnector
batterycompartment
batterycover
1. Open the battery compartment: Slide the battery cover
in the direction of the arrow on the battery cover (see
above picture).
2. If replacing the battery, remove the old battery.
3. A battery connector is located in the battery compart-
ment. Attach a new 9V battery to the connector.
4. Install the connected battery in the battery compart-
ment.
5. Slide the battery cover back to close the compartment.
s NOTICE:IfthePocketDopplerwillnotbeusedfora
prolongedperiodoftime,removethebatteryfromthe
device.
s NOTICE:Keepthebatteryawayfromobjectsormate-
rialswithstaticelectriccharges.

14423-INS-LAB-RevD11 19
s NOTICE:Ifthebatteryterminalsbecomedirty,wipe
themwithaclean,dryclothbeforeusingthePocket
Doppler.
s NOTICE:Batterieshavelifecycles.Ifthebatteryuse
timeshortensnoticeably,thebattery'slifecycleis
over.Replacetheoldbatterywithanewoneofthe
samesizeandtype.Useonlybatteriesrecommended
byGFHealthProducts,Inc.
s NOTICE:Removeabatterywhoselifecycleisover
fromthePocketDopplerimmediately.
s NOTICE:Disposeoftheoldbatteryinaccordance
withlocalregulations.

14423-INS-LAB-RevD11 20
6 OPERATION
PROBEOPERATION
RemovingtheProbefromthePocketDoppler
s NOTICE:Donotdragordroptheprobe.Donotdis-
connecttheprobefromthePocketDoppler.
1. The probe is installed in Pocket Doppler probe frame
(left picture above). Hold the Pocket Doppler main unit
with one hand and hold the top of the probe with the
other hand.
2. Gently remove the top of the probe from the Pocket
Doppler probe frame (center picture above).
3. Remove the entire probe from Pocket Doppler probe
frame (right picture above).
PlacingtheProbeinthePocketDoppler
s NOTICE:Donotdragordroptheprobe.Donotdis-
connecttheprobefromthePocketDoppler.
1. Hold the Pocket Doppler main unit with one hand and
hold the probe with the other hand.
2. Gently guide the middle of the probe into the Pocket
Doppler's probe frame (center picture above).
3. Gently replace the top of probe entirely into the Pocket
Doppler's probe frame (left picture above).