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 pro-
fessional.
14423-INS-LAB-RevD11
Download from Www.Somanuals.com. All Manuals Search And Download.
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
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
3
Download from Www.Somanuals.com. All Manuals Search And Download.
OPTIONAL ACCESSORIES
The following accessories for use with the Grafco Ultrason-
ic Pocket Doppler are available from your GF Health Prod-
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
4
Download from Www.Somanuals.com. All Manuals Search And Download.
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 specific 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 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 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
5
Download from Www.Somanuals.com. All Manuals Search And Download.
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 qualified healthcare professional.
WARNING: Do not use the Grafco Pocket Doppler in a
flammable atmosphere where concentrations of flam-
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 fire.
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 certified 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 configurations 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 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.
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
6
Download from Www.Somanuals.com. All Manuals Search And Download.
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-
fied 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 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-
fied 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
7
Download from Www.Somanuals.com. All Manuals Search And Download.
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
8
Download from Www.Somanuals.com. All Manuals Search And Download.
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
9
Download from Www.Somanuals.com. All Manuals Search And Download.
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 with-
in 15 days of delivery. The carrier will provide all paper-
work 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-RevD11
10
Download from Www.Somanuals.com. All Manuals Search And Download.
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
11
Download from Www.Somanuals.com. All Manuals Search And Download.
4 ULTRASOUND POCKET DOPPLER
AND ACCESSORIES
APPEARANCE AND FEATURES
The following figures illustrate the Pocket Doppler with the
2.0 MHz water-resistant probe, and accompanying tables
describe labeled features.
Front Panel
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
Flashing
Battery too low for
operation; replace battery
immediately
Brand
Brand of Pocket Doppler
Probe
Speaker
The Probe is used to perform ultrasound monitoring
The built-in speaker makes the fetal sounds audible
14423-INS-LAB-RevD11
12
Download from Www.Somanuals.com. All Manuals Search And Download.
Power
Button
Turns the Ultrasound Pocket Doppler ON or
OFF
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-RevD11
13
Download from Www.Somanuals.com. All Manuals Search And Download.
Rear Panel
Feature
Function
Pocket Clip
Attaches Pocket Doppler to pocket
Attachment
Battery
Opens to install/replace battery
Attaches probe to Pocket Doppler
Compartment
Probe Frame
14423-INS-LAB-RevD11
14
Download from Www.Somanuals.com. All Manuals Search And Download.
Top Panel
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 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 configurations 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 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-RevD11
15
Download from Www.Somanuals.com. All Manuals Search And Download.
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
16
Download from Www.Somanuals.com. All Manuals Search And Download.
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
4.0 MHz
8.0 MHz
Water-Resistant Water-Resistant Water-Resistant
Probe
Vascular
Probe *
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
SNxxxxx:
Water-Resistant
IPX8
The probe is 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.
(Water-Resistant)
* 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
17
Download from Www.Somanuals.com. All Manuals Search And Download.
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 socket
battery compartment
battery connector
battery cover
battery installation
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
18
Download from Www.Somanuals.com. All Manuals Search And Download.
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
19
Download from Www.Somanuals.com. All Manuals Search And Download.
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).
14423-INS-LAB-RevD11
20
Download from Www.Somanuals.com. All Manuals Search And Download.
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 Dop-
pler probe:
1. Follow steps 1-3 in previous section, Removing the
Probe from the Pocket Doppler.
2. Remove the connector: Grasp
probe connector body and gen-
tly pull out from Pocket Doppler
probe socket.
3. Connect the new probe's con-
nector: Grasp probe connec-
tor body and gently insert into
Pocket Doppler's probe socket.
Pocket Doppler is shown at
right with disconnected probe.
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 con-
ditions).
TURNING ON THE POCKET DOPPLER
Press the front panel POWER button to turn on the Pocket
Doppler.
14423-INS-LAB-RevD11
21
Download from Www.Somanuals.com. All Manuals Search And Download.
FETAL HEART (FH) MONITORING
FH Monitoring with 2.0 MHz Water-Resistant Probe
Refer to picture at right. The au-
dio 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 umbili-
cus. During monitoring, prolonged lying in the supine
position should be avoided. Sitting up or lateral posi-
tions are preferable and may be more comfortable for
the mother.
14423-INS-LAB-RevD11
22
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
23
Download from Www.Somanuals.com. All Manuals Search And Download.
1. Apply a liberal amount of gel on the site to be exam-
ined.
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-RevD11
24
Download from Www.Somanuals.com. All Manuals Search And Download.
7 MAINTENANCE
WARNING: Failure on the part of the responsible facil-
ity employing the use of this equipment to implement
a satisfactory maintenance schedule may cause un-
due 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 po-
tential 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 sus-
pected, contact GF Health Products, Inc. Technical
Service at the number on the back cover or your GF
authorized distributor before use.
WARNING: The following safety checks/tests must be
performed at least once every two years or as speci-
fied 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 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-
fied 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
25
Download from Www.Somanuals.com. All Manuals Search And Download.
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, and/or gamma
radiation sterilization on this device or its accesso-
ries.
CLEANING
WARNING: Before cleaning the Pocket Doppler or
probes, turn the Pocket Doppler power off and re-
move 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 al-
low 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 liquid or cleaning solution
to remain on the surface of the Pocket Doppler or
probe after cleaning.
14423-INS-LAB-RevD11
26
Download from Www.Somanuals.com. All Manuals Search And Download.
Cleaning the Pocket Doppler Probe
s NOTICE: Do not allow liquid to enter the ultrasound
system.
s NOTICE: Do not pour liquids on the probe 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 liquid or cleaning solution
to remain on the surface of the probe after cleaning.
14423-INS-LAB-RevD11
27
Download from Www.Somanuals.com. All Manuals Search And Download.
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 recommend-
ed in the previous section.
2. To disinfect the probe, immerse the probe in a solution
of Benzalkonium Bromide, 0.5% Chlorhexidine, 2% Glu-
taraldehyde, 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 liquid or cleaning solution
to remain on the surface of the probe after cleaning.
14423-INS-LAB-RevD11
28
Download from Www.Somanuals.com. All Manuals Search And Download.
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
Water-Resistant
Probe
IPX8 Water
Ingress
Protection
Code, which
indicates
4.0 MHz
Water-Resistant
Vascular Probe
this probe
can work
continuously
for 5 hours
when being
immersed in
water less than
1 meter deep
8.0 MHz
Water-Resistant
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-RevD11
29
Download from Www.Somanuals.com. All Manuals Search And Download.
Physical
Size (Width x
3.35 x 1.26 x 5.43 inches
Characteristics
Depth x Height) (85 x 32 x 138 mm)
Weight
.64 lb (290 ±5g)
(including a
battery and a
probe)
Environment
Working
Temperature
Humidity
41°F ~ 104°F
(5°C ~ 40°C)
≤80% RH
Atmospheric
Pressure
12.47 ~ 15.37 psi
(86 ~ 106 kPa)
Transport and Temperature
Storage
14°F ~ 131°F (-
10°C ~ +55°C)
Humidity
≤93% RH
Atmospheric
Pressure
12.47 ~ 15.37 psi
(86 ~ 106 kPa)
FHR
FHR Measuring 50 bpm ~ 210 bpm
Range
Performance
Resolution
Accuracy
0.5W
1 bpm
±3 bpm
Audio Output
Power
Battery
Battery Type
9 volt DC alkaline battery, IEC Type
Recommended No. 6LR61/6LF22 or equivalent
Battery Stand- > 10 hours
by Time
14423-INS-LAB-RevD11
30
Download from Www.Somanuals.com. All Manuals Search And Download.
Ultrasound
Nominal
Frequency
2.0 MHz
Water-Resistant
Probe
2.0 MHz
4.0 MHz
Water-Resistant
Vascular Probe
4.0 MHz
8.0 MHz
Water-Resistant
Vascular Probe
8.0 MHz
Working
Frequency
2.0 MHz
2.0 MHz ±10%
4.0 MHz ±10%
8.0 MHz ±10%
Water-Resistant
Probe
4.0 MHz
Water-Resistant
Vascular Probe
8.0 MHz
Water-Resistant
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 Water-Resistant
of Transducer Probe
4.0 MHz
Water-Resistant
Vascular Probe
8.0 MHz
Water-Resistant
Vascular Probe
14423-INS-LAB-RevD11
31
Download from Www.Somanuals.com. All Manuals Search And Download.
9 LIMITED WARRANTY
GF Health Products Inc. warrants this product to be free from
manufacturing defects in material and workmanship for
its period of warranty that is in accordance with industry
standards. 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.
GF Health Products, Inc. warrants the Grafco Pocket Doppler
and its components to be free from defects in workmanship
and materials for a period of one year.
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 com-
mences 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 defec-
tive, 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, RE-
PLACEMENT, 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 your GF Health Products, Inc. prod-
uct. 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
14423-INS-LAB-RevD11
32
Download from Www.Somanuals.com. All Manuals Search And Download.
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 sat-
isfactory 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 negli-
gence, abuse, misuse, improper operation, improper main-
tenance, 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 LIM-
ITED TO THE IMPLIED WARRANTIES OF MERCHANT-
ABILITY 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, RE-
PLACEMENT, CREDIT AND/OR REFUND OF THE DEFEC-
TIVE PRODUCT OR PART PURSUANT TO THE TERMS
CONTAINED HEREIN. GF HEALTH PRODUCTS, INC.
SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL
OR INCIDENTAL DAMAGES WHATSOEVER.
14423-INS-LAB-RevD11
33
Download from Www.Somanuals.com. All Manuals Search And Download.
This warranty gives you specific legal rights and you may also
have other legal rights which vary from state to state (prov-
ince 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.
The warranties contained herein contain all the representa-
tions 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-RevD11
34
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
35
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
36
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
37
Download from Www.Somanuals.com. All Manuals Search And Download.
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 struc-
tures, 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 theoreti-
cally with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be consid-
ered. If the measured field strength in the location in which the Grafco
Ultrasound Pocket Doppler is used exceeds the applicable RF compli-
ance level above, the Grafco Ultrasound Pocket Doppler should be ob-
served 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-RevD11
38
Download from Www.Somanuals.com. All Manuals Search And Download.
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 struc-
tures, objects and people.
14423-INS-LAB-RevD11
39
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
40
Download from Www.Somanuals.com. All Manuals Search And Download.
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-RevD11
41
Download from Www.Somanuals.com. All Manuals Search And Download.
13 INDEX
A
Introduction 3
Accessory equipment, certifica-
tion of 6
Appendix A, EC Declaration of
Conformity 35
Appendix C, Overall Sensitivity
40
L
Left panel features and illustra-
tion 16
M
Maintenance 25
N
NOTICE statement, significance
5
O
B
Operation 20
Battery, installing / replacing 18
P
Pocket Doppler, intended use 3
Pocket Doppler, turning off 24
Pocket Doppler, turning on 21
Pocket Doppler and accessories
12
Probe, FH monitoring with 22
Probe, placing in the Pocket Dop-
pler 20
C
CAUTION statement, significance
5
Cleaning 26
D
Display panel 12
E
Electromagnetic emissions—for
all equipment and systems
Electromagnetic immunity—for all
equipment and systems (Ap-
Electromagnetic immunity—for all
equipment and systems that
are not life-supporting (Ap-
pendix B) 37
Probe, removing from the Pocket
Doppler 20
Probe, swapping 21
Probe operation 20
Probes, vascular 17
F
Probe socket 13
Fetal Heart (FH) monitoring 22
Freight policy, GF Health Prod-
Front panel features and illustra-
tion 12
R
Rear panel features and illustra-
tion 13
Recommended separation dis-
tances (Appendix B) 38
G
S
Guidance and manufacturer’s
Safety information 5
Specifications 29
START/STOP button 16
I
Info statement, significance 5
14423-INS-LAB-RevD11
42
Download from Www.Somanuals.com. All Manuals Search And Download.
T
Telephone number, Graham-Field
Top panel features and illustra-
tion 15
U
User manual, contents of 3
V
Volume control 16
W
WARNING statement, signifi-
cance 5
14423-INS-LAB-RevD11
43
Download from Www.Somanuals.com. All Manuals Search And Download.
USA Corporate Headquarters:
GF Health Products, Inc.
2935 Northeast Parkway
Atlanta, Georgia 30360
telephone: 770-368-4700
14423-INS-LAB-RevD11
© 2011 GF Health Products, Inc.
Download from Www.Somanuals.com. All Manuals Search And Download.
|
