Graham Field Baby Accessories 14423 2 User Manual

14423-2 / 14423-4 / 14423-8  
UltrasoUnd Pocket doPPler  
User ManUal  
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 qualified healthcare  
professional.  
14423-INS-LAB-RevE13  
 
1 IntroduCtIon  
This user manual contains important information and  
safety precautions for the Grafco Ultrasound Pocket  
Doppler. 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  
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  
Doppler 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 Health Products, Inc.  
authorized distributor, or your physician.  
InCluded features  
Mini USB Probe Socket  
Probe Detector  
Built-in Speaker  
Adjustable Volume  
Alkaline Battery: LR6, AA, 1.5V  
Low Battery Detector / Indicator  
Obstetrical or Vascular Monitoring  
14423-INS-LAB-RevE13  
3
 
optIonal aCCessorIes  
The following accessories for use with the Grafco  
Ultrasonic Pocket Doppler are available from your  
GF Health Products, Inc. authorized distributor or  
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 Waterproof Probe  
14423-4P 4.0 MHz Waterproof Vascular Probe  
14423-8P 8.0 MHz Waterproof Vascular Probe  
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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 sections, which may be the same as or similar to the  
following, or specific to the operations. WARNING and  
CAUTION statements must be observed. To avoid the  
possibility of injury, observe the following precautions  
during the operation of the instrument.  
Please note the following special statements, used  
throughout this manual, and their significance:  
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  
practice 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-RevE13  
5
 
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  
instructed by a qualified healthcare professional.  
WARNING: Do not use the Grafco Pocket Doppler in  
a flammable atmosphere where concentrations of  
flammable anesthetics or other materials may occur.  
WARNING: Do not expose batteries to heat.  
WARNING: Do not attempt to charge alkaline  
batteries; they may leak or catch on fire.  
WARNING: DO NOT simultaneously touch signal  
input or output connector and the patient.  
WARNING: Accessory equipment connected to  
the analog and digital interfaces must be certified  
according to the respective IEC standards (e.g.  
IEC 950 for data processing equipment and IEC  
60601-1 for medical equipment). Furthermore all  
configurations shall comply with the valid version  
of the system standard IEC 60601-1-1. Anyone who  
connects additional equipment to the signal input  
connector, or signal output connector, configures  
a medical system, and is therefore responsible for  
verifying 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  
meters) from the patient.  
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WARNING: Use only 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  
operation, ensure that the environment in which the  
device is operated is not subject to any source of  
strong electromagnetic interference, such as radio  
transmitters, mobile telephones, etc.  
WARNING: The following safety checks/tests must  
be performed at least once every two years or  
as specified in your facility's test and inspection  
protocol, by a qualified person with adequate  
training, knowledge, and practical experience:  
• Inspect the equipment for mechanical and  
functional damage.  
• Ensure the safety labels are legible.  
• Verify that the device functions properly as  
described 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  
specified limit. Record the data and store with  
the Grafco Pocket Doppler. If the device is not  
functioning properly 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  
Health Products, Inc. authorized distributor.  
14423-INS-LAB-RevE13  
7
 
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  
environment clean and dust-free. Protect the  
device from vibration, corrosive medicine, and high  
temperatures.  
s NOTICE: Do not use high-temperature sterilizing  
process, low temperature steam, E-beam, or  
gamma radiation 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  
materials 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 useful 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  
local regulations.  
s NOTICE: Do not dispose of this device with  
household waste. Dispose of this device in  
accordance with your local laws and regulations.  
14423-INS-LAB-RevE13  
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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-RevE13  
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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 file 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  
within 15 days of delivery. The carrier will provide all  
paperwork necessary to file 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-RevE13  
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Inspection  
Check the Pocket Doppler for nicks, dents, scratches,  
mechanical or other damage. Check all the cables and  
accessories.  
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  
-4°F (-20°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%.  
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4 ultrasound poCket doppler  
and aCCessorIes  
appearanCe and features  
The following figures illustrate the Pocket Doppler with  
the 2.0 MHz waterproof probe, and accompanying tables  
describe labeled features.  
front panel  
Display Panel  
POWER Button  
Probe  
Speaker  
Probe Socket  
feature function  
display  
Displays system info  
panel  
System status The system status LED is at the left bottom  
corner of the display panel. Please see  
the following table for significance of LED  
indicators.  
LED  
led  
led  
significance  
Illumination Illumination  
Color  
Green  
Condition  
Constant  
Flashing  
Power on  
Probe disconnected or not  
properly connected  
Orange  
Grafco®  
Flashing  
Battery too low for  
operation; replace battery  
immediately  
brand  
probe  
The Probe is used to perform ultrasound monitoring  
14423-INS-LAB-RevE13  
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speaker  
The built-in speaker makes the fetal sounds audible  
power  
Turns the Ultrasound Pocket Doppler ON or  
OFF  
button  
probe  
The probe connects here to the Ultrasound Pocket Doppler  
socket  
Jack  
denition  
Power Supply  
Signal  
1
2
3
4
5
6
Probe Coding 1  
Probe Coding 2  
Probe Coding 3  
(Shell) GND  
14423-INS-LAB-RevE13  
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rear panel  
Probe  
Frame  
Battery  
Compartment  
Probe Socket  
feature  
function  
battery  
Opens to install/replace battery  
Compartment  
probe frame  
Stores probe when not in use  
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top panel  
Earphone Socket  
feature function  
socket  
name  
picture  
function  
Charge  
Socket  
Not used  
Earphone  
Socket  
Connect earphone  
Signal  
1
2
3
4
5
GND  
Interface  
Signal  
Signal  
Signal  
Signal  
Warning  
Refer to accompanying documents  
(this user manual)  
WARNING: Accessory equipment connected to  
the analog and digital interfaces must be certified  
according to the respective IEC standards (e.g. IEC  
950 for data processing equipment and IEC 60601-1  
for medical equipment). Furthermore all configurations  
shall comply with the valid version of the system  
standard IEC 60601-1-1. Anyone who connects  
additional equipment to the signal input connector or  
signal output connector configures 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-RevE13  
15  
 
left panel  
Volume  
Control  
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-RevE13  
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poCket doppler Waterproof probes  
The 2.0 MHz, 4.0 MHz and 8.0 MHz waterproof 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  
appearance:  
pocket doppler Waterproof probe label table  
picture of probe  
probe label  
text  
2.0 mhz  
Waterproof  
probe  
4.0 mhz  
Waterproof  
vascular  
probe *  
8.0 mhz  
Waterproof  
vascular  
probe *  
Cd  
Continuous Wave Doppler  
x.0 (Central  
Central  
frequency =  
2.0 MHz  
Central  
frequency =  
4.0 MHz  
Central  
frequency =  
8.0 MHz  
frequency)  
a
Probe Version Number  
Probe Serial Number  
The Probe is Waterproof  
snxxxxx:  
Waterproof  
Ipx8  
Water Ingress Protection Code, which indicates  
this probe can work continuously for 5 hours when  
immersed in water up to one meter deep.  
(Waterproof)  
* Vascular probes are used to monitor arteries and veins  
battery  
See Section 5, SetuP, for battery installation and  
replacement instructions.  
WARNING: Use only 1.5V alkaline battery (AA, LR6) or  
Ni-MH 1.2V rechargeable battery in this device.  
14423-INS-LAB-RevE13  
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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 1.5V alkaline battery (AA, LR6) or  
Ni-MH 1.2V rechargeable battery in this device.  
battery cover  
battery installation  
1. Open the battery compartment. Turn the Pocket  
Doppler upside down. Hold the main unit with one  
hand; press with thumb of other hand on the cover  
notch and push it upward and forward. The battery  
compartment will be open.  
2. If replacing the battery, remove the old battery.  
3. Install the battery, using 1.5V alkaline battery or Ni-MH  
1.2V battery.  
s NOTICE: Ensure battery direction matches cover  
symbols.  
4. Close the battery compartment.  
s NOTICE: If the Pocket Doppler will not be used for a  
prolonged period of time, remove the battery from the  
device.  
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s NOTICE: Keep the battery away from objects or  
materials with static electric charges.  
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-RevE13  
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6 operatIon  
probe operatIon  
removing the probe from the pocket doppler  
s NOTICE: Do not drag or drop the probe. Do not  
disconnect the probe from the Pocket Doppler.  
1. The probe is stored  
in the Pocket Doppler  
probe frame. 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.  
3. Remove the entire  
probe from the Pocket  
Doppler probe frame.  
placing the probe in the pocket doppler  
s NOTICE: Do not drag or drop the probe. Do not  
disconnect 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.  
3. Gently replace the top of  
the probe entirely into  
the Pocket Doppler's  
probe frame.  
14423-INS-LAB-RevE13  
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swapping probes  
s NOTICE: Do not drag or drop the probe or the probe  
connector.  
The Pocket Doppler is shipped with one probe connected.  
To replace the connected probe with another Pocket  
Doppler probe:  
1. Follow steps 1-3 in previous section, Removing the  
Probe from the Pocket Doppler.  
2. Grasp probe connector body and gently pull out from  
Pocket Doppler probe socket.  
3. Connect the new probe's connector: Grasp probe  
connector body and gently insert into Pocket Doppler's  
probe socket.  
s NOTICE: Place the unused probe in a secure location.  
When the Pocket Doppler is not used for a long time,  
store Doppler and probe in original packaging (see  
Maintenance/Storage section for proper storage  
conditions).  
turnIng on the poCket doppler  
Press the front panel POWER button to turn on the Pocket  
Doppler.  
14423-INS-LAB-RevE13  
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fetal heart (fh) monItorIng  
fh monitoring with 2.0 mhz Waterproof probe  
Refer to picture at right. The  
audio fetal heart beat is sent  
out via the built-in speaker or  
attached earphone.  
1. Palpate for the fetus position  
to find the best location to  
place the probe and hear the  
fetal heart rate.  
2. Apply a liberal amount of gel to the probe head.  
3. Place the probe head on the desired location. Assure  
that good coupling of the gel to the skin is achieved; the  
Fetal Heart rate will not be heard if adequate gel is not  
used and air is between the probe head and skin.  
4. Slowly move the probe until a clear heart rate is heard.  
5. Adjust the volume to the desired level.  
WARNING: It is not possible to monitor FHR unless  
an audible fetal heart signal is present. The fetal  
pulse can be distinguished from the maternal pulse  
by feeling the mother’s pulse during the examination.  
WARNING: For best quality audio, place the probe in  
the optimum position.  
WARNING: For best quality audio, avoid positions  
with strong placental sounds (swishing) or fetal cord  
pulse (indistinct pulse at fetal rate).  
WARNING: If the fetus is in the cephalic position  
and the mother is supine, the clearest heart sound  
will normally be found on the midline below the  
umbilicus. During monitoring, prolonged lying in  
the supine position should be avoided. Sitting up  
or lateral positions are preferable and may be more  
comfortable for the mother.  
14423-INS-LAB-RevE13  
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vasCular monItorIng WIth 4.0 or 8.0 mhz  
probe (optIonal)  
The 4.0 MHz and 8.0 MHz probes can be used to perform  
vascular monitoring assessment of blood flow.  
The 8.0 MHz probe is used for more superficial evaluation  
than the 4.0 MHz probe. Refer to the following probe site  
illustration to determine the best probe to utilize.  
14423-INS-LAB-RevE13  
23  
 
1. Apply a liberal amount of gel on the site to be  
examined.  
2. Place the probe so that the head is at least at 45º to the  
vessel to be examined.  
3. Adjust the position of the probe to obtain the loudest  
audio signal. For best results, keep the probe as still as  
possible once the optimum position is located.  
4. Adjust the audio volume as necessary.  
Info: Arteries emit high-pitched rhythmical pulsation  
sounds, while veins emit non-rhythmical pulsation sounds  
similar to rushing wind.  
turnIng off the poCket doppler  
1. When the session is finished, press the front panel  
POWER button to turn off the Pocket Doppler.  
2. Use a clean, dry, non-abrasive cloth to gently wipe off  
the remaining gel from the probe. After thoroughly  
cleaning the probe, replace it in the Pocket Doppler  
probe frame.  
replaCIng the battery  
When the Pocket Doppler battery power is low, turn the  
power off and replace the battery. See Section 5, SetuP,  
for instructions on battery replacement.  
14423-INS-LAB-RevE13  
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7 maIntenanCe and CleanIng  
WARNING: Failure on the part of the responsible facility  
employing the use of this equipment to implement a  
satisfactory maintenance schedule may cause undue  
equipment failure and possible health hazard.  
maIntenanCe  
WARNING: Before use, inspect the Pocket Doppler  
and probe(s) to ensure there is no visible evidence of  
damage which may affect the functioning of the device  
or pregnant woman’s safety, or create the potential for  
the device to operate in an unsafe manner. Thereafter,  
inspect the device for evidence of damage at least  
once each week. If damage is evident or suspected,  
contact GF Health Products, Inc. Technical Service  
at the number on the back cover or your GF Health  
Products, Inc. authorized distributor before use.  
WARNING: The following safety checks/tests must  
be performed at least once every two years or  
as specified in your facility's test and inspection  
protocol, by a qualified person with adequate  
training, knowledge, and practical experience:  
• Inspect the equipment for mechanical and  
functional damage.  
• Ensure the safety labels are legible.  
• Verify that the device functions properly as  
described 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  
specified limit. Record the data and store with  
the Grafco Pocket Doppler. If the device is not  
functioning properly 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  
Health Products, Inc. authorized distributor.  
14423-INS-LAB-RevE13  
25  
 
s NOTICE: Keep the Pocket Doppler and its  
environment clean and dust-free. Protect the  
device from vibration, corrosive medicine, and high  
temperatures.  
s NOTICE: Do not use high-temperature sterilizing  
process, low temperature steam, E-beam, and/or  
gamma radiation sterilization on this device or its  
accessories.  
CleanIng  
WARNING: Before cleaning the Pocket Doppler  
or probes, turn the Pocket Doppler power off and  
remove the battery.  
s NOTICE: Do not use strong solvent such as acetone  
to clean Pocket Doppler or probe.  
s NOTICE: Do not use an abrasive such as steel wool  
or metal polish to clean Pocket Doppler or probe.  
s NOTICE: Do not allow any liquid to enter the probe  
socket while cleaning the Pocket Doppler or probe.  
Cleaning the pocket doppler  
s NOTICE: Do not immerse Pocket Doppler. Do not  
allow liquid to enter the ultrasound system.  
s NOTICE: Do not pour liquids on the Pocket Doppler  
while cleaning.  
1. Keep the exterior surface of the Pocket Doppler clean  
and free of dust and dirt.  
2. Clean the exterior surface of the unit with a clean, dry,  
nonabrasive cloth.  
3. If necessary, clean the unit with a clean cloth dampened  
with soap and water, then immediately wipe dry with a  
clean, dry, non-abrasive cloth.  
s NOTICE: Do not allow any cleaning solution to remain  
on the surface of the Pocket Doppler or the probe  
after cleaning.  
14423-INS-LAB-RevE13  
26  
 
Cleaning the pocket doppler probe  
s NOTICE: Do not allow liquid to enter the ultrasound  
system.  
s NOTICE: Do not pour liquids on the ultrasound  
system or probe socket while cleaning.  
The Pocket Doppler probe’s acoustic surface is fragile and  
must be handled with care.  
1. To prolong the life of the probe, after each use, gently  
wipe off the remaining gel from the probe with a clean,  
dry, non-abrasive cloth.  
2. After thoroughly cleaning the probe, replace it in the  
Pocket Doppler probe frame.  
3. If necessary, wipe the external surface of probe with  
70% ethanol or isopropranol alcohol.  
4. Allow to air dry.  
s NOTICE: Do not allow any cleaning solution to remain  
on the surface of the Pocket Doppler or the probe  
after cleaning.  
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dIsInfeCtIon  
disinfecting the pocket doppler probe  
s NOTICE: Do not allow any liquid to enter the probe  
socket while disinfecting or immersing the probe.  
1. Clean the exterior surface of the probe as  
recommended in the previous section.  
2. To disinfect the probe, immerse the probe in a solution  
of Benzalkonium Bromide, 0.5% Chlorhexidine, 2%  
Glutaraldehyde, or 75% ethanol.  
3. Wipe the probe with a clean, dry, non-abrasive cloth to  
remove any remaining moisture.  
s NOTICE: Do not allow any cleaning solution to remain  
on the surface of the Pocket Doppler or the probe  
after disinfecting.  
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8 speCIfICatIons  
model number  
14423-2  
Ultrasonic Pocket Doppler  
with 2.0 MHz probe  
and name  
14423-4  
Ultrasonic Pocket Doppler  
with 4.0 MHz probe  
14423-8  
Ultrasonic Pocket Doppler  
with 8.0 MHz probe  
safety  
Complies with: EN 60601-1/1990  
Classification  
Anti-electric  
Shock Type  
Internally powered equipment  
Anti-electric  
Shock Degree  
Type B equipment  
Degree of  
Protection  
against  
Harmful  
Ingress of  
Water  
Main Unit  
Non-protected  
2.0 MHz  
Waterproof  
Probe  
IPX8 Water  
Ingress  
Protection  
Code, which  
indicates this  
probe can work  
continuously for  
5 hours when  
being immersed  
in water within 1  
meter  
4.0 MHz  
Waterproof  
Vascular Probe  
8.0 MHz  
Waterproof  
Vascular Probe  
Degree of  
Safety in  
Presence of  
Flammable  
Gases  
Equipment not suitable for use in  
presence of flammable gases  
Working  
System  
Continuous running equipment  
Group I Class B  
EMC  
14423-INS-LAB-RevE13  
29  
 
physical  
Size  
(W x D x H)  
3.50 x 1.34 x 5.55 inches  
(89 x 34 x 141 mm)  
Characteristics  
Weight  
(including  
battery)  
.66 lb (<300 g)  
environment  
Working  
Temperature  
Humidity  
41°F ~ 104°F  
(5°C ~ 40°C)  
25% - 80%  
(non-condensing)  
Atmospheric  
Pressure  
12.47 psi ~ 15.37 psi  
(860hPa ~ 1060 hPa)  
Transport and Temperature  
Storage  
-4°F ~ 131°F  
(-20°C ~ 55°C)  
Humidity  
25% - 93%  
(non-condensing)  
Atmospheric  
Pressure  
10.15 psi ~ 15.37 psi  
(700hPa ~ 1060 hPa)  
fhr  
FHR Measuring 50 bpm ~ 210 bpm  
Range  
performance  
Resolution  
Accuracy  
0.5W  
1 bpm  
±3 bpm  
audio output  
power  
battery  
Battery Type  
1.5V alkaline battery  
Recommended (IEC 60086, LR6/AA) or  
Ni-MH 1.2V rechargeable battery  
Battery  
Stand-by Time  
> 9 hours  
14423-INS-LAB-RevE13  
30  
 
ultrasound  
Nominal  
Frequency  
2.0 MHz  
Waterproof  
Probe  
2.0 MHz  
4.0 MHz  
Waterproof  
Vascular Probe  
4.0 MHz  
8.0 MHz  
Waterproof  
Vascular Probe  
8.0 MHz  
Working  
Frequency  
2.0 MHz  
Waterproof  
Probe  
2.0 MHz ±10%  
4.0 MHz ±10%  
8.0 MHz ±10%  
4.0 MHz  
Waterproof  
Vascular Probe  
8.0 MHz  
Waterproof  
Vascular Probe  
P-  
< 1MPa  
Iob  
< 10 mW/cm2  
< 100mW/cm2  
Ispta  
Working Mode Continuous Wave Doppler  
Effective  
2.0 MHz  
245mm2 ±15%  
32mm2 ±15%  
14mm2 ±15%  
Radiating Area Waterproof  
of Transducer Probe  
4.0 MHz  
Waterproof  
Vascular Probe  
8.0 MHz  
Waterproof  
Vascular Probe  
14423-INS-LAB-RevE13  
31  
 
9 lImIted Warranty  
GF Health Products Inc. warrants the Grafco Pocket Doppler  
and its components to be free from manufacturing defects  
for a period of one year. This warranty is extended only to  
the original purchaser/consumer or dealer/non-consumer of  
this new product and to no other purchaser or transferee.  
The Warranty period for the consumer commences on the  
first date a product is delivered to consumer by seller/  
dealer. If the product is rented or leased, the warranty period  
commences on the invoice date from GF Health Products,  
Inc. A copy of the invoice showing date of purchase must  
be provided when submitting warranty claims. When proof  
of purchase date is not provided, warranty coverage shall  
commence upon GF Health Products, Inc.’s invoice date to  
the dealer/purchaser.  
If within the warranty period, the product or component  
part is proven to GF Health Products, Inc.’s satisfaction to  
be defective, GF Health Products, Inc. shall provide, at its  
option, one of the following: (1) repair or replacement of  
any defective or nonconforming part or product or (2) a  
credit and/or refund of the original selling price. GF HEALTH  
PRODUCTS, INC.’S SOLE OBLIGATION AND YOUR EXCLUSIVE  
REMEDY UNDER THIS WARRANTY SHALL BE LIMITED TO  
SUCH REPAIR, REPLACEMENT, CREDIT AND/OR REFUND.  
This warranty does not include any labor charges incurred  
in replacement part(s) installation or any associated freight  
or shipping charges to the manufacturer.  
For warranty service, please contact the authorized dealer  
from whom you acquired yourGF Health Products, Inc.product.  
Upon receiving notice of an alleged defect in a product, GF  
Health Products, Inc. will issue a return authorization. The  
defective product or part(s) must then be returned, at the  
purchaser’s cost, for warranty inspection using the serial  
number as identification (or, if the product is not serialized,  
lot number and date code) within thirty (30) days of return  
authorization issue date. In the event you do not receive  
14423-INS-LAB-RevE13  
32  
 
satisfactory warranty service, please contact GF Health  
Products, Inc. at the address below. DO NOT return products  
to our factory without prior authorization.  
LIMITATIONS AND EXCLUSIONS: The foregoing warranty  
shall not apply to serial numbered products if the serial  
number has been removed or defaced. Products subjected  
to negligence, abuse, misuse, improper operation, improper  
maintenance, improper cleaning, improper storage, or  
damages beyond GF Health Products, Inc.’s control are not  
covered by this warranty, and that evaluation shall be solely  
determined by GF Health Products, Inc. This warranty shall not  
apply to problems arising from normal wear and tear or failure  
to follow instructions. The warranty shall also not apply to  
products modified without GF Health Products, Inc.’s express  
written consent; nor shall it apply if parts not manufactured  
by GF Health Products, Inc., or if parts not complying with  
original equipment specifications are added to GF Health  
Products, Inc. products, or if the product or part is serviced  
by an entity not authorized by GF Health Products, Inc.  
The foregoing warranty is exclusive and in lieu of all other  
express warranties and implied warranties, including but  
not limited to the implied warranties of merchantability and  
fitness for a particular purpose, and shall not extend beyond  
the duration of the express warranty provided herein, and  
the remedy for violations of any implied warranty shall be  
limited to the repair, replacement, credit and/or refund of the  
defective product or part pursuant to the terms contained  
herein. GF Health Products, Inc. shall not be liable for any  
consequential or incidental damages whatsoever.  
This warranty gives you specific legal rights and you may  
also have other legal rights which vary from state to state  
(province to province). Some states (provinces) do not allow  
the exclusion or limitation of incidental or consequential  
damage, or limitation on how long an implied warranty lasts,  
so the above exclusion and limitations may not apply to you.  
14423-INS-LAB-RevE13  
33  
 
The warrantiescontainedhereincontainalltherepresentations  
and warranties with respect to the subject matter of this  
document, and supersede all prior negotiations, agreements  
and understandings with respect thereto. The recipient of  
this document hereby acknowledges and represents that it  
has not relied on any representation, assertion, guarantee,  
warranty, collateral contract or other assurance, except those  
set out in this document.  
GF Health Products, Inc. (“Graham-Field”)  
2935 Northeast Parkway  
Atlanta, GA 30360  
Tel 770-368-4700  
14423-INS-LAB-RevE13  
34  
 
10 appendIx a, eC deClaratIon of  
ConformIty  
eC declaration of Conformity  
Manufactured for  
GF Health Products, Inc., 2935 Northeast Parkway,  
Atlanta, GA 30360  
Product  
Ultrasound Pocket Doppler  
(MDD, Annex IX): IIa  
Classification  
We herewith declare that the above mentioned product(s) meet the  
transposition into national law, the provisions of Council Directive  
93/42/EEC of 14 June 1993 concerning medical devices - as amended by  
Directive 98/79/EC on in vitro diagnostic medical devices.  
All supporting documentation is retained at the premises of the  
manufacturer.  
Directives  
General Applicable Directives: Medical Device  
Directive: COUNCIL DIRECTIVE 93/42/EEC of 14  
June 1993 concerning medical devices (MDD 93/42/  
EEC).  
Standards applied EN ISO 9001, ISO13485, EN ISO14971, EN ISO10993-  
1, IEC 601-1, EN 60601-1-1, BS EN 60601-1-4, IEC  
60601-1-2, EN 61157, EN 1041, EN 60417-2-2000,  
IEC/TR 60878-2003, EN 980, EN 55011, ISO 1000, YY  
0111-93, EN 61266, EN ISO 780 , GB/T 14740, GB/T  
15464  
Notified Body  
TÜV SÜD Product Service GmbH, Ridlerstr 65,  
D-80339 München, Germany.  
Identification  
number  
14423-INS-LAB-RevE13  
35  
 
11 appendIx b, emC InformatIon  
guIdanCe and manufaCturer’s  
deClaratIon  
electromagnetic emissionsfor all equipment  
and systems  
guidance and manufacturers declaration—  
electromagnetic emission  
The Grafco Ultrasound Pocket Doppler is intended for use in the  
electromagnetic environment specified below. Do not use the system in  
environments which do not comply with the specifications listed below.  
emission  
Compliance  
electromagnetic environment–  
test  
guidance  
RF emission Group 1  
CISPR 11  
The Grafco Ultrasound Pocket Doppler  
uses RF energy only for its internal function.  
Therefore, its RF emissions are very low  
and are not likely to cause any interference  
in nearby electronic equipment.  
RF emission Class B  
CISPR 11  
The Grafco Ultrasound Pocket Doppler  
is suitable for use in all establishments,  
including domestic establishments and  
those directly connected to the public  
low-voltage power supply network that  
supplies buildings used for domestic  
purposes.  
electromagnetic Immunityfor all equipment  
and systems  
guidance and manufactures declarationelectromagnetic  
immunity  
The Grafco Ultrasound Pocket Doppler is intended for use in the  
electromagnetic environment specified below. Do not use the system in  
environments which do not comply with the specifications listed below.  
Immunity IeC 60601 Compliance electromagnetic  
test  
test level level  
environmentguidance  
Electrostatic ±6 kV  
±6 kV  
Floors should be wood,  
discharge contact ±8 contact ±8  
concrete or ceramic tile. If  
floor is covered with synthetic  
material, the relative humidity  
should be at least 30% RH.  
(ESD) IEC kV air  
61000-4-2  
kV air  
14423-INS-LAB-RevE13  
36  
 
electromagnetic Immunityfor all equipment  
and systems that are not life-supporting  
guidance and manufacturers declaration—  
electromagnetic immunity  
The Grafco Ultrasound Pocket Doppler System is intended for use in the  
electromagnetic environment specified below. Do not use the system in  
environments which do not comply with the specifications listed below.  
Immunity IeC 60601 Compliance electromagnetic  
test  
test level level  
environmentguidance  
Radiated  
RF IEC  
3 V/m 80  
3 V/m  
Portable and mobile RF  
MHz to 2.5  
communications equipment  
should be used no closer to any  
part of the Grafco Ultrasound  
Pocket Doppler, including  
61000-4-3 GHz  
cables, than the recommended  
separation distance calculated  
from the equation applicable to  
the frequency of the transmitter.  
recommended separation  
distance  
80 MHz to  
800 MHz  
800 MHz to  
2.5 GHz  
Where P is the maximum output  
power rating of the transmitter  
in watts (W) according to the  
transmitter manufacturer and d  
is the recommended separation  
distance in meters (m).  
Field strengths from fixed RF  
transmitters, as determined  
by an electromagnetic site  
survey,a 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:  
14423-INS-LAB-RevE13  
37  
 
Info 1: At 80 MHz and 800 MHz, the higher frequency range applies.  
Info 2: These guidelines may not apply in all situations. Electromagnetic  
propagation is affected by absorption and reflection from  
structures, objects and people.  
a: Field strengths from fixed transmitters, such as base stations for radio  
(cellular/cordless) telephones and land mobile radios, amateur radio,  
AM and FM radio broadcast and TV broadcast cannot be predicted  
theoretically with accuracy. To assess the electromagnetic environment  
due to fixed RF transmitters, an electromagnetic site survey should be  
considered. If the measured field strength in the location in which the  
Grafco Ultrasound Pocket Doppler is used exceeds the applicable RF  
compliance level above, the Grafco Ultrasound Pocket Doppler should  
be observed to verify normal operation. If abnormal performance is  
observed, additional measures may be necessary, such as reorienting or  
relocating the Grafco Ultrasound Pocket Doppler.  
b: Over the frequency range 150 kHz to 80 MHz, field strengths should  
be less than 3 V/m.  
recommended separation distances  
recommended separation distances between portable  
and mobile rf communications equipment and the grafco  
ultrasound pocket doppler  
The Grafco Ultrasound Pocket Doppler is intended for use in an  
electromagnetic environment in which radiated RF disturbances are  
controlled. The customer or the user of the device can help prevent  
electromagnetic interference by maintaining a minimum distance between  
portable and mobile RF communications equipment (transmitters) and the  
Grafco Ultrasound Pocket Doppler as recommended below, according to the  
maximum output power of the communications equipment.  
rated  
maximum  
output power  
of transmitter  
(W)  
separation distance according to  
frequency of transmitter (m)  
80 mhz to 800 mhz  
800 mhz to 2.5 ghz  
0.01  
0.1  
1
0.1167  
0.3689  
1.1667  
3.6893  
11.6667  
0.2334  
0.7378  
2.3334  
7.3786  
23.3334  
10  
100  
14423-INS-LAB-RevE13  
38  
 
For transmitters rated at a maximum output power not listed previously,  
the recommended separation distances in meters (m) can be estimated  
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.  
Info 1: At 80 MHz and 800 MHz, the separation distance for the higher  
frequency range applies.  
Info 2: These guidelines may not apply in all situations. Electromagnetic  
propagation is affected by absorption and reflection from  
structures, objects and people.  
14423-INS-LAB-RevE13  
39  
 
12 appendIx C, overall sensItIvIty  
overall sensitivity (2 mhz probe)  
Diameter Distance Reflection  
Two-way Attenuation B=∑Ba+Bw  
of  
(d)  
Loss A  
(d)  
Target  
Reflector  
(mm)  
(mm)  
∑Ba  
Bw  
(dB)  
B
(dB)  
(T:mm  
20 4.8 4.0  
Ba 40 9.6 8.0  
20 4.8 3.4  
Ba 40 9.6 6.8  
20 4.8 3.4  
Ba 40 9.6 6.8  
Ba:dB)  
1.58  
50  
45.7  
T
-
-
-
-
-
-
-
-
0
57.6  
56.4  
56.4  
49.6  
60.8  
58.4  
56.4  
51.6  
A=45.7dB  
@2 MHz  
75  
45.7  
45.7  
45.7  
43.2  
43.2  
43.2  
43.2  
T
0
0
0
0
0
0
0
100  
200  
50  
T
T
20 4.8  
-
-
Ba 40 9.6  
2.38  
A=43.2dB  
@2 MHz  
T
20 4.8 3.4 2.2  
Ba 40 9.6 6.8 4.4  
75  
T
20 4.8 3.4  
Ba 40 9.6 6.8  
20 4.8 3.4  
Ba 40 9.6 6.8  
1
2
-
100  
200  
T
-
T
20 4.8  
1
2
-
Ba 40 9.6  
-
Doppler 333  
Frequency  
(Hz)  
14423-INS-LAB-RevE13  
40  
 
overall sensitivity (2 mhz probe)  
Diameter  
of  
Target  
Reflector  
(mm)  
Vn  
(r.m.s.) (r.m.s.)  
mV mV  
Vn  
Overall  
Sensitivity  
(S=A(d)+B+C)  
dB  
dB  
1.58  
A=45.7dB  
@2 MHz  
186  
94  
5.93  
5.78  
5.82  
5.68  
109.2  
107.8  
107.9  
100.9  
175  
174  
173  
90  
89  
90  
2.38  
A=43.2dB  
@2 MHz  
178  
170  
165  
160  
89  
90  
85  
85  
6.02  
5.52  
5.76  
5.49  
110.0  
107.1  
105.3  
100.2  
Doppler Velocity of Target 12.5  
Frequency (cm/s)  
(Hz)  
14423-INS-LAB-RevE13  
41  
 
13 Index  
A
I
Accessories, optional 4  
Accessory equipment,  
certification of 6  
Address, GF Health Products, Inc.  
34  
Appendix A, EC Declaration of  
Conformity 35  
Appendix B, EMC information 36  
Appendix C, Overall Sensitivity  
40  
Info statement, significance 5  
Introduction 3  
L
Left panel features and illustration  
16  
M
Maintenance 25  
Maintenance and cleaning 25  
N
NOTICE statement, significance  
B
5
Battery, installing / replacing 18  
O
Battery terminals, cleaning 19  
Operation 20  
C
P
CAUTION statement, significance  
Pocket Doppler, handling 10  
Pocket Doppler, inspection 11  
Pocket Doppler, intended use 3  
Pocket Doppler, storage 11  
Pocket Doppler, turning off 24  
Pocket Doppler, turning on 21  
Pocket Doppler, unpacking 10  
Pocket Doppler and accessories  
12  
Probe, disinfection 28  
Probe, FH monitoring with 22  
Probe, placing in the Pocket  
Doppler 20  
5
Cleaning 26  
D
Display panel 12  
E
Electromagnetic emissions—for  
all equipment and systems  
(Appendix B) 36  
Electromagnetic immunity—for  
all equipment and systems  
(Appendix B) 36  
Electromagnetic immunity—for  
all equipment and systems  
that are not life-supporting  
(Appendix B) 37  
Probe, removing from the Pocket  
Doppler 20  
Probe, swapping 21  
F
Probe operation 20  
Fetal Heart (FH) monitoring 22  
Freight policy, GF Health  
Products, Inc. 10  
Front panel features and  
illustration 12  
Probes, vascular 17  
Probe socket 13  
R
Rear panel features and  
illustration 13  
G
Recommended separation  
distances (Appendix B) 38  
Guidance and manufacturer’s  
declaration (Appendix B) 36  
14423-INS-LAB-RevE13  
42  
 
S
Safety information 5  
Specifications 29  
START/STOP button 16  
T
Telephone number, GF Health  
Products, Inc. 34  
Top panel features and illustration  
15  
U
User manual, contents of 3  
V
Volume control 16  
W
WARNING statement,  
significance 5  
Warranty, limited 32  
14423-INS-LAB-RevE13  
43  
 
GF Health Products, Inc.  
2935 Northeast Parkway  
Atlanta, Georgia 30360  
telephone: 770-368-4700  
14423-INS-LAB-Reve13  
© 2013 GF Health Products, Inc.  
 

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