McKesson Lumeon Series User manual

DOPPLERS
USER’S MANUAL
© 2015 McKesson Medical-Surgical Inc.

Thank you for choosing McKesson LUM ON®S RI S Doppler Systems. Your total
satisfaction is our highest priority as we strive to continually improve our products and
services. Please contact us with any suggestions. We look forward to enjoying a long-term
relationship with you!
TABLE OF CONTENTS:
Intended Use/Contraindications/Warnings...........................................................................1
Description of Product..........................................................................................................1
Operation and Installation.....................................................................................................3
Obtaining Doppler Signals ................................................................................................... 4
Maintenance and Cleaning ...................................................................................................6
Replacing Batteries...............................................................................................................7
Troubleshooting ....................................................................................................................7
Clinical References ...............................................................................................................8
Accessories...........................................................................................................................8
Specifications........................................................................................................................9
Please read the manual carefully and become familiar with the operation, features and
maintenance of your Doppler prior to using the device or accessories.
Manufactured for McKesson Medical-Surgical Inc.
By CooperSurgical, Inc.
Year of manufacture located on device.
i

INTENDED USE
Obstetric (2 and 3 MHz Probes)
This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular (4, 5 and 8 MHz Probes)
This product will be used to detect blood flow in veins and arteries for assisting in the
detection of peripheral vascular disease.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Contraindications
WA NING: The vascular probes (4, 5 and 8 MHz) are not for fetal use.
WA NING: The ultrasound probes are not to be used on or near the eyes.
WA NING: The device is for use only on intact skin.
WA NING: Do not plug any part of this device into a telephone or
modem system.
WA NING: This device is not intended for use with HF surgical equipment.
If there are questions or concerns regarding these warnings or contraindications, please do
not hesitate to contact Customer Service for further clarification.
CAUTION: Dropping the Doppler, probe or accessories may cause damage to the housing
or electronics.
In order to preserve, protect and improve the quality of the environment, protect
human health and utilize natural resources prudently and rationally – do not
dispose of waste electrical or electronic equipment (W ) as unsorted municipal
waster. Contact local W disposal sites.
Safety of Ultrasound
McKesson LUM ON®S RI S Dopplers were designed with physician and patient safety in
mind. In early design phases, all potential hazards were eliminated or reduced to As Low As
Reasonably Achievable (ALARA) by adhering to good design practices and industry wide
safety standards. Ultrasound procedures should be performed with the ALARA principle in
mind when delivering ultrasound energy into the body.
DESC IPTION OF P ODUCT
The McKesson LUM ON®S RI S Doppler is factory configurable to include many
different features and product enhancements. Along with user interchangeable ultrasound
transducers, the McKesson LUM ON®S RI S Doppler device is well suited to meet your
specific needs.
Main Unit
The main handheld unit is ergonomically designed to fit the palm of your hand with comfort
and allow easy access to each control feature. ach unit is individually tested and inspected
to ensure the highest quality standards.
SSQ – Superior Sound Quality. very McKesson LUM ON®S RI S Doppler is
designed with a state of the art sound system that produces excellent sound quality and
long-term reliability.
1

LCD Display – The LCD display (optional) allows you to view the fetal heart rate in larger easy
to read digits, monitor battery life, and observe signal strength indicators, and features multiple
diagnostic indicators that ensure your unit is functioning at peak performance levels.
Units without LCD display incorporate bright, easy to read L D indicators that also allow you
to monitor battery life.
Main Unit Features Probe Type (see next page for details)
Catalog # Sound Display 2 MHz 3 MHz 4 MHz 5 MHz 8 MHz
1154 XX
(probe not included)
1155
(no display or probe) X
1156 XX X
1157 XX X
1158 XX
1159 XX
1160 XX
Probes
McKesson LUM ON®S RI S Doppler ultrasound transducers were designed to meet your
specific applications needs. ach probe has been ergonomically designed for comfort while
providing excellent maneuverability for locating the fetus or vascular target. ach probe is
carefully measured and tested to ensure it meets exacting performance standards.
2 MHz – Late-term obstetrical examination. This probe frequency is typically used during the
last trimester for deep fetal positions associated with larger women.
3 MHz - arly and general-purpose obstetrical examination. This probe frequency is a
general-use model ideal for most stages of fetal examination. Fetal heart sounds can be heard
as early as 12 weeks and sometimes sooner depending on the position and size of the fetus.
4 MHz Broad - This unique peripheral vascular probe is ideal for quickly locating brachial, radial
and ankle arteries in the performance of Ankle/Brachial Index testing. The broad beam of the
4 MHz probe allows the user to place the probe over the general location of the artery and with
very little movement find the vessel for fast blood pressure measurements.
5 MHz Tip - This standard “pencil” style probe is an excellent vascular tool for locating deep
specific vessels in the peripheral vascular system. The narrow grip and small face of the probe
make it ideal for maneuvering for maximizing the signal. 8 MHz Tip - This standard “pencil”
style probe is an excellent vascular tool for locating shallow specific vessels in the peripheral
vascular system. The narrow grip and small face of the probe make it ideal for maneuvering for
maximizing the signal.
Probe Application
MF # Type Late OB General OB PV ABI PV General
1156 2 MHz X
1157 3 MHz X
1158 4 MHz X
1159 5 MHz X
1160 8 MHz X
2

3
OPE ATION AND INSTALLATION
(Some fea ures are op ional)
SP AK R GRILL
ON/OFF BATT RY L V L
INDICATOR L D
ON/OFF
BUTTON
RCHARG
LD
PROB
CLIP
PROB
CONN CTOR
H AD/PHON /AUDIO
CONN CTOR
“PLAY” L D
“R CORD” L D
B LT CLIP
MOD L/S RIAL NUMB R
LAB L
VOLUM SLID R
BATT RY DOOR

4
Turning Unit On/Off
Turn the unit on by pressing the On/Off button. L D or LCD indicators (depending on the model)
indicate power status.
The McKesson LUM ON®S RI S Doppler automatically shuts itself off after 3 minutes if it is
not being used. This complete power shutdown preserves the life of the batteries and
ensures the unit will be ready for operation in case it was accidentally left on.
Diagnostic Monitoring (LCD Display units only)
Once the unit is on, the McKesson LUM ON®S RI S Doppler display units perform a series
of diagnostic checks. The unit first checks and temporarily displays the frequency of the probe
that is being used. This display will not reappear unless the probe is changed or the power is
cycled, in which case the display will again temporarily confirm the frequency of probe that
is connected.
The unit then checks for proper internal operating temperature, battery voltage, reference voltage
and power supply voltage levels. If any of these characteristics are out of range, the display will
show the RROR indicator and a failure code associated with the diagnostic error. Diagnostic
functions are periodically checked while the unit is on to ensure the Doppler is operating at peak
performance. Refer to the Troubleshooting section for a listing of failure codes.
BATTE Y MONITO ING
All McKesson LUM ON®S RI S Doppler units perform continuous battery monitoring and give
a visual indication of battery level. Display units use a multiple level battery-shaped icon that in-
dicates the voltage level of the battery. The battery outline will flash when the battery level is
very low, indicating that the user should change the batteries soon after the current examination
is complete.
Non-display units use the On/Off L D as a battery indicator by flashing at a low rate
(approximately once per second) when the battery level is low. Several exams can still
be performed in this state of operation. The battery indicator will flash at a higher rate
(approximately twice per second) when the battery level is very low. The user should change
the batteries soon after the current exam is complete.
OBTAINING DOPPLE SIGNALS
Caution: Doppler examinations should be performed only by trained individuals.
For any Doppler examination, it is essential that an adequate supply of coupling gel is used to
transmit the ultrasound energy from the probe to the surface of the skin. Reapply more gel if it
starts to dry out or spread so thinly that an air gap occurs between the probe and the skin. It is
not necessary to cover the entire surface of the probe, only the probe face. Applying too much
gel makes the unit difficult to clean and does not aid in the performance of the probe.
Volume Slider
The audio level can be adjusted using the Volume Slider. Moving the slider up will increase the
volume, while moving it down will decrease it.
BPM MHz
ERROR
REC
BATT RY
L V L/R CHARG
INDICATOR
PLAY INDICATOR
R CORD INDICATOR
H ART RAT INDICATOR
PROB FR QU NCY INDICATOR
RROR INDICATOR
DIGITAL DISPLAY
AR A
SIGNAL QUALITY INDICATOR

5
Signal Quality Indicator (Display units only)
An inadequate signal can produce erroneous rates from the heart rate calculation. The signal
level that is being obtained is shown on the Signal Quality Indicator bars. This indicator
provides a visual aid in obtaining a strong audio signal by showing the pulsatile nature of the
signal. A large difference between the highest and lowest signal bars that are lit confirms
that the quality of the signal is good and thus ensures the heart rate calculation is operating
at peak performance. The heart rate can be verified manually by counting the audible beats
for 20 seconds and multiplying by 3, or for 15 seconds and then multiplying by 4. Counting
for less than 15 seconds is not recommended due to a decrease in accuracy with the small
sample size.
Obstetrical
Fetal heart sounds are quite different from peripheral vascular blood flow sounds. Fetal sounds
are typically much lower in frequency and much higher in rate. For early term fetal detection,
start the probe at the pubic bone and slowly move along the midline – rocking the probe slowly
from side to side until a heartbeat is heard. For mid to late term fetal detection the best chance
of finding the heart sounds are to start on the fundus and move toward the navel and from one
side of the abdomen to the other, slowly rocking the probe until the heartbeat is heard. The fetal
heart reminds many people of a galloping horse and can vary in tone from a distant swishing
sound to a hard clopping.
Many times when attempting to detect the fetal heart, the maternal vascular sounds are heard
instead of (or in some cases, in addition to) the fetal sounds. These maternal sounds can come
from one of the major arteries, the placenta or the umbilical cord. The maternal vascular sounds
are typically higher in frequency at a lower rate. The heart rate calculation will display either the
maternal rate or the fetal rate, whichever portion of the signal is stronger.
If the fetal heart sounds cannot be located using the McKesson LUM ON®S RI S Doppler
procedure as described above, a second exam should be performed using another
commercially available fetal monitor as a repeated test.
5 and 8 MHz Vascular
Peripheral arterial sounds are typically higher in frequency. For the best sounds, angle the probe
approximately 45 degrees from the skin surface over the general location of the vessel. Slowly
move the probe side to side and vary the angle of the probe until the vascular sounds are heard.
Changing the angle of the probe has an effect on the frequency of the sound. The steeper the
probe angle is, the higher the frequency of the sound.
Peripheral venous sounds are not typically periodic and vary greatly depending on patient move-
ment and breathing. These sounds are more like the wind at the ocean and vary in pitch as the
patient moves or breathes.
4 MHz Vascular
The use of the 4 MHz vascular probe is the same as the 8 MHz as described above, except
tilting the probe 45 degrees is not necessary since the crystals are angled inside the probe cap.
This allows the user to simply place the probe flat on the peripheral vascular surface to scan for
the flow sounds by moving the flat probe face across the skin surface above the vessel.
Proper alignment of the 4 MHz vascular probe
with respect to the vessel

6
MAINTENANCE AND CLEANING
WARNING: The McKesson LUM ON®S RI S Doppler is not designed for liquid immersion.
Do not soak the Doppler main unit or probes in liquids. Use only spray or wipe cleaners and
disinfectants. Do not use products containing bleach.
WA NING: The McKesson LUM ON®S RI S Doppler is not designed for sterilization
processes such as autoclaving, gamma radiation or hydrogen gas.
WA NING: The McKesson LUM ON®S RI S Doppler is not intended to be used on open
skin. If there is evidence of open wound contamination, disinfect the probe before using
again as described below.
The McKesson LUM ON®S RI S Doppler requires very little maintenance. However, it is
important to continuing function of the unit and the health of the patients that the unit is
cleanedand examined regularly per the following guidelines:
After every examination:
xcess gel should be wiped off prior to docking the probe. Probes and main unit should
be cleaned with a damp cloth using warm water or presaturated isopropyl alcohol wipes. In
particular, pay close attention to clean the seams along the plastic lines at the probe face but
do not allow water to enter through the connectors or speaker grill.
To disinfect unit, use commercially available spray or wipe disinfectants registered with the
PA. Clorox®Broad Spectrum Quaternary Disinfectant is the only disinfectant that is Wallach
Surgical Devices approved for use on this McKesson LUM ON®S RI S product. Follow
the manufacturer’s instructions and wipe until it is dry of solutions. xaminers should wash
hands and change gloves after every exam. Refer to local and hospital policies for cleaning
and disinfection policies.
Store unit in a clean area free from dust and debris. Follow temperature and humidity guide-
lines as specified at the end of this manual.
WA NING: If the unit is to be stored for longer than 90 days without use, remove the bat-
teries prior to storage.
Periodically (at least annually): Inspect the main unit and probes for signs of cracks or
breaks in the mechanical housing. Inspect cables and connectors for signs of wear or failure.
The user should discontinue use of the unit with any sign of loss of housing integrity. Contact
a McKesson LUM ON®S RI S Doppler representative for service.
It is recommended that rechargeable batteries be replaced annually.

7
EPLACING BATTE IES
WA NING: Replace rechargeable batteries only with batteries supplied by McKesson
Medical-Surgical Inc. See accessories list for part number and re-order information.
WA NING: The battery compartment only accepts AA size batteries. See accessories list
for part number and re-order information.
Open the battery compartment by depressing the tab and pulling outward on the battery
door. Remove the existing drained batteries by pushing on the end of the battery that
compresses the battery contact spring and lift upwards. It is acceptable to carefully use a
simple tool, such as a pen, to assist in lifting the batteries out.
Batteries slide into compartment
Replace the batteries by paying close attention to the polarity indicators on the battery and
the polarity indicators on the battery holder in the compartment. Positive (+) aligns with
positive (button) and negative (-) aligns with negative (spring). Insert the battery such that
the spring contacts are loaded first and then press the battery firmly into place. After all three
have been inserted, replace the battery door.
WA NING: If the batteries have been inserted incorrectly, the unit will not function but the
McKesson LUM ON®S RI S Doppler will not be damaged.
T OUBLESHOOTING
WA NING: Use alternate equipment in case of unit failure. Call Service Department if the
probe or main unit malfunctions.
Poor sound quality
• Inadequate gel use
• Try to relocate the probe for a better signal
• Improper choice of probe frequency
• Interference from other equipment
• Probe coiled cable or battery contacts intermittent
• Debris in the speaker may cause poor sound
• Device damage from dropping the device, probes or accessories
Heart ate inaccurate
• Try to relocate the probe for a better signal – refer to Signal Strength indicator
• For OB, ensure maternal sounds are not mixing with fetal sounds
• nsure by manual counting that the rate is between 50 and 210 BPM
Battery indicator flashing
• Consult Battery Monitoring; replace batteries as described in Replacing Batteries
• Probe frequency does not match the connected probe
• Check probe that is attached to ensure it is the correct one: If correct probe, contact
Customer Service
Probe frequency 0.0
• No probe is attached: If probe is attached, contact Customer Service
• rror 5 or 7
• Batteries are low. They require replacement or recharging.

8
ADIO F EQUENCY INTE FE ENCE
The McKesson LUM ON®S RI S Doppler was tested for immunity to electromagnetic
interference at a level of 3 V/meter. Interference during normal operation may occur in the
presenceof fields stronger than 3 V/meter. If this occurs, try to increase the distance between
the McKesson LUM ON®Doppler and the source of interference. Contact a McKesson
LUM ON®representative for more information.
Diagnostic Codes – Contact Customer Service
1 – Temperature too low 5 – 5 Volt Supply too low
2 – Temperature too high 6 – 5 Volt Supply too high
3 – Reference Voltage too low 7 – Battery Voltage too low
4 – Reference Voltage too high 8 – Battery Voltage too high
eference materials for Obstetrical and Peripheral Vascular testing:
Handbook of Fe al Hear Ra e Moni oring; Julian T. Parer, 1997
Doppler Ul rasound and I s Use In Clinical Measuremen ; Peter Atkinson and
John P. Woodcock, 1982
Noninvasive Diagnosis of Peripheral Vascular Disease; W. Robert Felix, Jr., 1988
Curren Noninvasive Vascular Diagnosis; Ali F. Aburahma, dward B. Diethrich,1988
Accessories
Contact a McKesson LUM ON®representative at 1-800-777-4908
for ordering and additional information.
Description Part Number
Rechargeable Battery B150
Alkaline Battery B155
Recharge Adaptor R150
Audio Cable CBL0002
Audio Headphone H150
Gel (60 gm) G150
Gel (250 gm) G155
Ultrasound Probe Cleaner C150
Carry Case K260

9
SPECIFICATIONS
Degree of protection against electric shock:
Type B Applied Part
Class II quipment
Degree of protection against ingress of water:
All probes: IPX4 – extending 2.5 cm from tip
IPX1 – entire probe 2.5 cm from tip, excluding connector
Designed and tested to meet:
I C601-1, I C60601-1-2, I C60601-1-4, I C60601-2-37, N5011-A
Dimensions (h x w x l): 140 x 70 x 35 mm
Weight: 320 grams
Operating temperature: 10 to 40 °C
Operating humidity: 30 to 75 %
Transport/Storage temperature: –20 to 50 °C
Transport/Storage humidity: 5 to 90%, non-condensing
(beyond 30 days, battery to be stored
between –20 and 30 °C)
Battery voltage, type: 3 – AA Alkaline 1.5 volt
(for non-rechargeable units)
3 – AA NiMH 1.5 volt (for rechargeable units)
(as applicable)
Battery life: Batteries provided by factory
1250, 1-minute exams (Alkaline)
Audio bandwidth and power: 350 Hz – 2 KHz, 0.5 W
Heart rate accuracy: ±3 BPM from 50 to 220 BPM
Audio cable pin out: 3.5 mm stereo plug
Operating Conditions: There are no user controls that affect the
ultrasound output.

x-6 (cm) 0.4 0.4
y-6 (cm) 0.6 0.6
Az (cm) 0.4
le. (cm) 0.8
ISPTA.3 ISPPA.3
ACOUSTIC OUTPUT MI (mW/cm2) (W/cm2)
Global Maximum Value 0.04 223 .22
Pr.3 (Mpa) 0.09
wo(mW) 12.8 0.13
fc(MHz) 5.3 5.3 5.3
zsp (cm) 0.85 0.85 0.85
10
Associated
Acoustic
Parameter
Beam Dimensions x-6 (cm) 0.5 0.5
y-6 (cm) 1.0 1.0
Az (cm) 0.45
le. (cm) 1.15
EBD
Transducer Model: McKesson LUM ON®S RI S 5 MHz Operating Mode: Continuous-Wave (cw)
Application(s): Peripheral Vascular
Associated
Acoustic
Parameter
Beam Dimensions
EBD
Transducer Model: McKesson LUM ON®S RI S 8 MHz Operating Mode: Continuous-Wave (cw)
Application(s): Peripheral Vascular
Transducer Model: McKesson LUM ON®S RI S 4 MHz Operating Mode: Continuous-Wave (cw)
Application(s): Peripheral Vascular
ISPTA.3 ISPPA.3
ACOUSTIC OUTPUT MI (mW/cm2) (W/cm2)
Global Maximum Value 0.05 278 .278
Pr.3 (Mpa) 0.07
wo(mW) 47.2 0.047
fc(MHz) 4.0 4.0 4.0
zsp (cm) 1.2 1.2 1.2
ISPTA.3 ISPPA.3
ACOUSTIC OUTPUT MI (mW/cm2) (W/cm2)
Global Maximum Value 0.02 140 .14
Pr.3 (Mpa) 0.07
wo(mW) 5.5 0.006
fc(MHz) 8.0 8.0 8.0
zsp (cm) 0.66 0.66 0.66
Associated
Acoustic
Parameter
Beam Dimensions x-6 (cm) 0.2 0.2
y-6 (cm) 0.4 0.4
Az (cm) 0.3
le. (cm) 0.6
EBD

ISATA the spatial-average temporal-average intensity (mwatts per cm2).
ISPTA.3 the derated spatial-peak temporal-average intensity (mwatts per cm2).
ISPPA.3 the derated spatial-peak pulse-average intensity (watts per cm2).
MI the Mechanical Index.
Pr.3 the peak rarefactional pressure (megapascals) associated with the
transmit pattern giving rise to the value reported for MI.
Wothe total time-average ultrasonic power (mwatts).
fcthe probe center frequency (MHz).
zspthe axial distance at which the reported parameter is measured (cm).
x-6, y-6 are the –6dB beam dim. in the x-y plane where zsp is found (cm).
BD the entrance beam dimensions (cm). These dimensions are the same as
the dimensions of the transmit crystal.
Measurement Uncertainties: Power: +34, -42%
Pressure: +11, -16%
Intensity (Ispta): +23, -26%
Frequency: ± 5%
Acoustic Output Parameters are measured in water. Derated values, denoted by the subscript
“.3”, take into account a conservative level of attenuation that would be encountered in the
human body. The derated intensity values (I.3) are obtained from water values of intensity (Iw)
at a depth of z calculated by:
I.3 = exp(-0.23*0.3*f*z)*Iw
(where f is the probe frequency in MHz and z is the depth in centimeters)
The derated peak rarefactional pressure is calculated from the value of measure water (pr) by:
Pr.3 = exp(-0.115*0.3*f*z)*pr
(where pressure is given in megapascals)
Additional Output eporting Information for IEC 61157
4 MHz: Iob < 91 mW/cm2
5 MHz: Iob < 51 mW/cm2
8 MHz: Iob < 39 mW/cm2
The 2 MHz, 2 MHz WP and 3 MHz obstetrical probes are exempt from the declaration
requirements of I C61157. These probes meet the conditions: Iob < 20 mW/cm2, Ispta
< 100mW/cm2, and Pr < 1 MPa. Iob is output power divided by beam area.
Note that parameter Zsp in the probe reporting tables is the same parameter as Ipin I C 61157.
11
ISATA (max) (mW/cm2) 19.6 15.5
Po(mW) 48.0 24.4
ffective Radiating Area (cm2) 2.45 1.57
Ultrasound Frequency (MHz) 2.1 MHz 3.2 MHz
Pulse Duration CW CW
Repetition Freq. CW CW
Obstetrical Probe Information:
MODEL NUMBE
VA IABLE DESC IPTION 2 MHz 3 MHz

12
NOTES:

13
NOTES:

MAN0025-IFU • Rev. A • 10/15
Lumeon®is a registered trademark of McKesson Medical-Surgical Inc.
Distributed B
McKesson Medical-Surgical Inc.
Richmond, VA 23233
Made in USA
Questions? Call 1-800-777-4908
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