14423-2 / 14423-4 / 14423-8
UltrasoUnd Pocket doPPler
User ManUal
Important: do not use the Pocket doppler
without first 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
14423-INS-LAB-RevE13
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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.
14423-INS-LAB-RevE13
6
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
8
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
10
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%.
14423-INS-LAB-RevE13
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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
12
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
definition
Power Supply
Signal
1
2
3
4
5
6
Probe Coding 1
Probe Coding 2
Probe Coding 3
(Shell) GND
14423-INS-LAB-RevE13
13
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
14423-INS-LAB-RevE13
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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
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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.
14423-INS-LAB-RevE13
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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
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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.
14423-INS-LAB-RevE13
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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.
14423-INS-LAB-RevE13
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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
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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
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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
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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 emissions—for all equipment
and systems
guidance and manufacturer’s 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 Immunity—for all equipment
and systems
guidance and manufacture’s declaration—electromagnetic
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
environment—guidance
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 Immunity—for all equipment
and systems that are not life-supporting
guidance and manufacturer’s 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
environment—guidance
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
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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
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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
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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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