Cooper Surgical Medasonics TRIA T334 User manual

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Table of Contents
Topic Page
Tria Order Information 1
Tria Drawing 2
Tria System Contents 3
Introduction 4
Obstetrical Use 5
Vascular Use 9
General Doppler Cautions and Considerations 12
General Doppler Care and Service 13
Battery Replacement 13
Return Policy 13
Warranty 15
Specifications 16
Ultrasonic Output 17
Definition of Terms 18
Troubleshooting 19
Regulatory Compliance 19
15 Forest Parkway • Shelton, CT 06484
(800)-227-8076 • (203)-929-6321
fax [phone]
www.coopersurgical.com

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Order Information
To order additional TRIA products or other MedaSonics Doppler products,
call Customer Service at (800)-227-8076 or (203)-929-6321.
Order Number Description
T334 TRIA Doppler & Interchangeable 2 MHz Fetal Probe
T335 TRIA Doppler & Interchangeable 5 MHz Vascular
T344 TRIA Doppler & Interchangeable 2 MHz Fetal and
5 MHz Vascular Probes
T345-D TRIA Fetal Doppler w/Accu-Rate Heart Rate Display
T336-D TRIA Waterproof Fetal Doppler w/Accu-Rate Heart
Rate Display
T-334-D TRIA Doppler w/Accu-Rate Heart Rate Display and 2
MHz Fetal & 5 MHz Vascular Probes
T345 TRIA Fetal Doppler (2 MHz)
T346 TRIA Vascular Doppler (5 MHz)
T336 TRIA Doppler & Waterproof Fetal Probe (2 MHz)
P338 TRIA 2 MHz Fetal Probe
P339 TRIA 5 MHz Vascular Probe
TRIA Doppler Mounting Systems
A062 Rollstand
A063 Bracket
TRIA Dopplers T345(D), T336(D), and T346 are available with a longer cord
for use with the Rollstand or Bracket. Order a TRIA-LC (i.e., T345-LC or
T345-DLC) when you order a Doppler to go with the mounting system.
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Speaker
Heart Rate Display
Interchangeable probes
(fetal and vascular)
Sure-Lock magnetic
probe connection
On/OFF and battery
LED indicators
Volume Control
On/OFF Button
Handheld Doppler
Now Available with
Accu-Rate
Heart Rate Display

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TRIA System Contents
Thank you for purchasing a MedaSonics Tria™Doppler System. MedaSonics
handheld Dopplers have been a standard of care for 30 years. We are committed
to continuous research and development, marketing and manufacturing of
quality products.
The Tria Doppler System is available with a 2 MHz Fetal Probe, a 5 MHz
Vascular Probe or a 2 MHz Waterproof Fetal Probe. Non-waterproof Doppler
probes can be purchased separately to allow greater versatility in multiple
clinical settings.
Before using your Doppler, ensure that the carton contains the items shown
below.
1 ea - Speaker Unit or 1 ea - Ultrasound Gel
Speaker Unit w/Display 1 ea - Carrying Case
1 ea - Doppler Probe 1 ea - Warranty Card
1 ea - 9V Battery 1 ea - User’s Manual
If any item is missing or appears damaged or if for any reason you are not
satisfied with your Doppler, please contact your supplier or MedaSonics
immediately. For more information on accessories or Dopplers, call our
Customer Service Department at (800)-227-8076 or (203)-929-6321 (in
the U.S.).
Introduction
The MedaSonics Tria Doppler System consists of a hand held unit contain-
ing the system controls and speaker, optional heart rate display, and one or
more Doppler probe(s) that contain the ultrasound transducer and Doppler
electronics. Choice of a probe depends on the clinical application.
The MedaSonics Tria 2 MHz Fetal Probe is designed specifically for detection
of the fetal heart rate and circulation. Clinical experience has demonstrated
that Doppler ultrasound is a simple, noninvasive aid in the management of
routine as well as problem pregnancies.
The MedaSonics Tria 5 MHz Vascular Probe is designed specifically for
detecting blood flow in the arterial and deep venous system of the extremi-
ties. Clinical experience has demonstrated that Doppler ultrasound is a sim-
ple, noninvasive aid in the assessment of venous and arterial flow in the
extremities.
The MedaSonics Tria Doppler Systems are based on the Doppler shift prin-
ciple. The tip of the Doppler contains two piezoelectric crystals. One crystal
transmits very low power ultrasonic waves at a frequency of approximately
2.3 MHz for the fetal and 5.1 MHz for vascular. As these ultrasonic waves
reach moving tissue such as blood cells, they are reflected and their pitch is
shifted slightly. This change in pitch is the Doppler shift. The receiving crys-
tal detects and amplifies these reflected waves. Further processing converts
the Doppler-shifted ultrasonic waves into the audible sounds of blood flow.

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Obstetrical Use: Fetal System
Product Description
The MedaSonics Tria Fetal Doppler System consists of a handheld speaker
or speaker with heart rate display unit and 2 MHz Probe. The probe is con-
nected to the unit via a coiled cord.
Speaker Unit with Optional Accu-Rate Heart Rate Display
The speaker unit is comprised of the electronics, battery compartment,
on/off power control, volume control, on/off and battery life LED indicators,
and optional heart rate display. The 3.5 mm audio output jack on the top of
the unit allows private listening with an optional stethoscope (available
through MedaSonics) or the connection of a recording device.
The green LED on the face of the unit is lit when the unit is turned on. When
the battery falls below optimum performance levels, the yellow LED
becomes lit prompting the user to change the battery.
The Accu-Rate Heart Rate Display calculates and displays the heart rate
once a signal is obtained. The rate is displayed in beats per minute and is
averaged over several beats. By watching the heart-shaped icon on the LCD
display, the user can verify the accuracy of the heart rate display number. If
the inner, solid black heart icon flashes in sync with the heart tones emitting
from the speaker, then the Doppler has “locked on” to the heart rate signal
and will accurately display the rate. If the inner heart icon flashes random-
ly in comparison to the audible heart tones, the unit has not “locked on” to
the signal and is erroneously identifying noise as the heart rate. When this
happens, increase the volume level on the Doppler. This increases the audio
signal upon which the algorithm can operate and will allow it to “lock on” to
the signal and accurately display the heart rate.
Standard Fetal Probe
The 1-inch diameter ultrasound transducer, located at the tip of the probe,
generates signals which are processed and can be heard through the speak-
er or optional stethoscope. The transducer frequency is 2.3 MHz.
Waterproof Fetal Probe
The waterproof fetal probe is also a 1-inch diameter ultrasound transducer
transmitting at 2.3 MHz. It is designed specifically for the assessment of
fetal heart rate and circulation in and during water births. The probe is
waterproof to IEC Ipx7 specifications. Caution: The speaker unit is not
waterproof. Care must be taken to avoid contact with water.
Probe Retention
The Doppler probe is held fast to the speaker unit with magnets which can
be seen in the pocket on the right side of the unit. Simply place the probe
gently in the pocket and the magnets will retain the probe for storage and
transport. While the retention force of the magnets is high, it cannot prevent
the dislodging of the probe under extreme conditions, such as high impact.
Probe Connection
To remove a probe from the system, gently pull the gray connector out from
the base of the probe. To connect a probe, line up the tab on the end of the
connector with the notch on the end of the wand and push gently until they
snap together.
Note: The probes on the waterproof and dedicated fetal Tria Systems are
permanently wired to the speaker unit and cannot be removed.
Battery
The Doppler requires one 9V alkaline battery which is located in a compart-
ment in the back of the speaker unit. Battery life will vary according to fre-
quency and duration of exam.

Note: A low battery can significantly degrade Doppler performance. When
the battery falls below optimum performance levels, the yellow LED on the
front of the unit becomes lit and the speaker volume will automatically drop
to an unusable level. This prompts the user to change the battery, returning
the Doppler to peak performance.
Operation (Speaker Unit)
On/Off Button : The On/Off button is located on the left-hand side of the
speaker unit. The green LED on the face of the unit is lit when the unit is
turned on.
Volume: The volume control is located on the left-hand side of the unit
below the on/off switch. Rotate the thumb wheel to achieve the volume that
is best for the application.
Outputs: The 3.5 mm audio output jack on the top of the unit allows con-
nection of a stethoscope or recording device. The speaker will automatical-
ly mute when the stethoscope is plugged in.
Instructions for Use
1) Ordinarily the patient will lie on her back, abdomen exposed. The exam-
ination can also be easily performed with the patient on her side, sitting or
standing.
2) Spread a generous amount of ultrasound coupling agent (ultrasound gel)
on the body surface to be examined. A fluid coupling agent is essential for
proper operation. Lack of signal can be due to loss of fluid coupling.
Commercial preparations provide good coupling; however, a soap solution
or even water can be used. Do not use alcohol as a coupling agent.
Note: Ultrasonic gel is not required for proper coupling during underwater use.
3) Ensure that the speaker unit and Doppler probe are securely connected
through the cord. Holding the Doppler probe, place the tip on the site to be
examined. Press the ON button. Adjust volume controls as desired.
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4) Search for fetal heart signals by slowly moving the instrument across the
abdomen. The sensitivity pattern is like a searchlight, so angle the Doppler
for the best signal. In general, the fetal pulse can be detected as soon as the
uterus is palpable above the pubic symphysis.
Clinical Usage: Obstetrical Exams
The Tria Doppler System may be used to:
1) Detect fetal heart rate at 9 weeks. In rare instances, reliable signals may
not be obtainable until after the first trimester.
2) Make frequent checks of fetal heart rate throughout labor and delivery,
particularly during and immediately following contractions. Clinical person-
nel can carry the instrument with them as they would carry a stethoscope.
3) Confirm the presence of a live fetus throughout pregnancy, even when
maternal obesity or hydramnios prevents hearing the fetal heartbeat with a
conventional stethoscope. The Doppler can also be used to detect multiple
pregnancies.
4) Ease the fear and concern of the anxious expectant mother. Hearing the
fetal heartbeat may be particularly reassuring early in pregnancy.
5) Aid in localizing the placenta in patients with third trimester bleeding and
prior to amniocentesis or intrauterine transfusion. Placental sounds have a
“blowing” characteristic, along with a pulsatile component. Accurate local-
ization of the placenta requires some practice in search and recognition tech-
niques.

Vascular Use: Vascular System
Product Description
The MedaSonics Tria Vascular Doppler System consists of a speaker unit and
5 MHz Probe. The probe is connected to the speaker unit via a coiled cord.
Speaker Unit
The speaker unit is comprised of the electronics, battery compartment,
on/off power control, volume control, on/off and battery life LED indicators.
The 3.5 mm audio output jack on the top of the unit allows private listening
with an optional stethoscope or the connection of a recording device.
The green LED on the face of the unit is lit when the unit is turned on. When
the battery falls below optimum performance levels, the yellow LED becomes
lit prompting the user to change the battery.
Vascular Probe
The 3/8-inch diameter ultrasound transducer, located at the tip of the probe,
generates signals which are processed and can be heard through the speaker
or optional stethoscope. The transducer frequency is 5.1 MHz.
Probe Retention
The Doppler probe is held fast to the speaker unit with magnets which can
be seen in the pocket on the right side of the unit. Simply place the probe
gently in the pocket and the magnets will retain the probe for storage and
transport. While the retention force of the magnets is high, it cannot prevent
the dislodging of the probe under extreme conditions, such as high impact.
Probe Connection
To remove the probe from the system, gently pull the gray connector out from the
base of the probe. To connect a probe, line up the tab on the end of the connector
with the notch on the end of the wand and push gently until they snap together.
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Note: The probe on the dedicated vascular Tria System is permanently wired to
the speaker unit and can not be removed.
Battery
The Doppler requires one 9V alkaline battery which is located in a compartment
in the back of the speaker unit. Battery life will vary according to frequency and
duration of exam.
Note: A low battery can significantly degrade Doppler performance. When the
battery falls below optimum performance levels, the yellow LED on the front of
the unit becomes lit and the speaker volume will automatically drop to an unusable
level. This prompts the user to change the battery, returning the Doppler to peak
performance.
Operation (Speaker Unit)
On/Off Button: The On/Off button is located on the left-hand side of the speaker
unit. The green LED on the face of the unit is lit when the unit is turned on.
Volume: The volume control is located on the left-hand side of the unit below
the on/off switch. Rotate the thumb wheel to achieve the volume that is best for
the application.
Outputs: The 3.5 mm audio output jack on the top of the unit allows connection
of a stethoscope or recording device.The speaker will automatically mute when
the stethoscope is plugged in.
Instructions for Use
Spread a generous amount of ultrasound coupling agent (ultrasound gel) on
the body surface to be examined. A fluid coupling agent is essential for proper
operation. Lack of signal can be due to loss of fluid coupling. Commercial
preparations provide good coupling, however, a soap solution or even water
can be used. Do not immerse the probe or use alcohol as a coupling agent.

Ensure that the speaker unit and the Doppler probe are securely connected
through the cord. Holding the Doppler probe, place the tip on the site to be
examined. Press the ON button. Adjust volume as desired.
Move the instrument very slowly across the surface being examined. The sensitivity
pattern is like a searchlight, so angle the Doppler for best signal. The frequency
(pitch) of the Doppler shifted sounds is related both to flow velocity and to the
angle between the instrument and the axis of flow. Do not press hard or blood
flow may be affected.
Clinical Usage: Vascular Exams
The Tria vascular Doppler may be used:
1) Following the results of reconstructive vascular surgery in the recovery room,
at bedside and later during office examinations. The noninvasive clinical evaluation
with this Doppler instrument can be directly related to arteriographic findings.
2) Taking systolic blood pressure using Doppler ultrasound. Leg and ankle
blood pressures taken by Doppler can provide information as to the severity of
arteriosclerotic disease of the legs and the location of the impaired segments.
3) Perioperative evaluation of the femoral artery when this artery is used as the
cannulation site in cardiopulmonary bypass procedures.
4) Screening for venous thrombosis and chronic venous insufficiency.
5) Taking a pulse rate or Doppler systolic blood pressure on the hypotensive
and hypovolemic patient.
6) Useful in checking any arterial injection or catheterization site before and
after such procedures.
7) Useful in emergency medicine and noisy environments to take blood pres-
sure, pulse rates and to evaluate suspected arterial injuries.
8) Urological applications include evaluation of carioceles, testicular torsion
diagnosis, and impotence assessment.
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General Doppler Cautions and Considerations
DANGER: Do not use the Tria Doppler in the presence of flammable anesthetics.
WARNING: This product is not designed for sterile use.
CAUTION:
Do NOT - immerse in any liquid (except the waterproof fetal probe)
- use high-temperature sterilizing processes (such as autoclaving)
- use solvent cleaners
- use E-beam or gamma radiation sterilization
Important: The 5 MHz vascular probe is not intended for fetal use.
The 2 MHz fetal probe is not intended for vascular use.
CAUTION: Federal law restricts this device to sale by or on the order of a
licensed practitioner.
Acoustic Safety
Acoustic Safety-According to the American Institute of Ultrasound in Medicine
(AIUM), “No confirmed biological effects on patients or instrument operators
caused by exposure at intensities typical of present diagnostic ultrasound
instruments have ever been reported. Although the possibility exists that such
biological effects may be identified in the future, current data indicate that the
benefits to patients of the prudent use of diagnostic ultrasound outweigh the
risks, if any, that may be present.”
The calculated derated intensity values for the fetal and vascular probes com-
pare very favorably with previously reported acoustic safety data for Doppler
ultrasound instruments. These values are appropriate for all clinical applica-
tions recommended in this manual.

General Doppler Care and Service
1) The transducer crystal area should be wiped clean with a tissue after each
use. Alcohol may be used if desired. Although MedaSonics does not recom-
mend or endorse any specific disinfecting agent to be used with MedaSonics
devices, many disinfecting products are commercially available. These prod-
ucts may be purchased at any local drug store. Do not autoclave the unit or
sterilize with Sterrad®or Steris®systems. Do not immerse the unit in liquid.
Avoid dropping it.
2) If the Doppler will be stored for a long time, the battery should be removed.
3) MedaSonics, Inc. maintains a service facility which has the capability to
promptly repair all products returned to the factory.
Due to the advanced technology that has made this product possible, there are no
user-serviceable parts inside the control unit or Doppler. Special equipment is
required for servicing this product, and can only be performed by your service
agent. For service, contact MedaSonics Service Department at (800)-227-8076 or
(203)-929-6321. Prepaid, insured shipment for factory service should be sent to:
Service Manager
CooperSurgical Inc.
15 Forest Parkway
Shelton, CT 06484
Battery Replacement
1) Press and lift the cover of the battery compartment, lift out used battery.
2) Insert new battery, ensuring polarity of battery corresponds with battery clip.
3) Slide the battery cover back into position.
Return Policy
A Return Material Authorization (RMA) number must be obtained before return-
ing any product. The product must be in new condition in the original packag-
ing, and shipped to MedaSonics prepaid with tracer capability. Restocking fees
are based on the following schedule:
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Time in the field Restock Fee
0 to 2 weeks 0%
2 to 4 weeks 25%
4 to 8 weeks 50%
>8 weeks 100%
Items returned without proper authorization are subject to a 50% Restock Fee.
Time in the field is based on the Ship Date of the equipment and the date the
unit is received back at MedaSonics—not the date the RMA is issued.

Limited Warranty
This warranty is in lieu of all other warranties, expressed or implied. In the
U.S.A., MedaSonics, Inc. (MedaSonics) warrants this Tria™System against
defects in material or workmanship as follows:
Parts – MedaSonics will repair or replace parts in exchange for defective parts
for a period of five (5) years after date of original purchase with no charge for
the parts. MedaSonics reserves the right to determine whether a part should be
repaired or replaced.
Labor – MedaSonics will repair this instrument with no labor charge for a peri-
od of one (1) year after the date of original shipment when it is shipped to the
MedaSonics Service Center. Transportation and insurance to the Service Center
are to be prepaid by the purchaser.
Limitations – This product is to be used only for the intended and labeled
indications presented in the literature accompanying the product. This
warranty shall not apply to any products repaired or altered by anyone not
authorized in writing by MedaSonics. MedaSonics makes no warranty of the
results to be obtained. MedaSonics’ sole responsibility shall be to replace or
repair this product under the terms stated above and does not cover loss or
damage from external causes such as, but not limited to, weather, theft or
abuse. This warranty does not apply to batteries, shipping case or other
accessories, or to damage from shipping, tampering, misuse or negligence.
Preventative maintenance, the refinishing or replacement of any cosmetic
defect or deterioration, or the replacement of batteries unless damaged by a
component failure, is not covered by this warranty. MedaSonics will not be
responsible for any loss, damage or injury resulting from delay in rendering
service under this warranty. MEDASONICS SHALL NOT BE RESPONSIBLE FOR
ANY SECONDARY CHARGES OR CONSEQUENTIAL DAMAGES FROM ANY
BREACH OF ANY WARRANTY, EXPRESSED OR IMPLIED. Since some states do
not allow the exclusion or limitation of consequential damages, some of this
limitation may not apply to you. This warranty gives you specific legal rights,
and you may also have other rights which vary from state to state.
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Tria Specifications
Size Speaker Unit Length 5.25” (133 mm)
Width 2.6” (66 mm)
Height1.75” (45 mm)
Probe Height4.7” (119 mm)
Width 1.1” (28 mm)
Weight Speaker Unit 9.7 oz. (275 gm) with battery
Probe 1.2 oz. (34 gm)
Doppler Technology Continuous Wave
Display Reflective liquid crystal display
Case Material ABS/Polycarbonate
Battery Type One 9V alkaline or rechargeable
alkaline battery
Battery Life Typically 250 x 1 minute exams
Ultrasound Frequency 2.36 MHz fetal
Transmitter 5.1 MHz vascular
Display Rate Performance Range: 60 - 200 bpm
Resolution: 1 bpm
Accuracy: 3 bpm

Ultrasonic Output: TRIA™ Fetal Doppler
Max MI WofcZsp x-6 (cm) EBD (cm)
Value (mW) (MHz) (cm) y-6 (cm)
ISPTA0.3 20.1 0.0162 3.79 2.40 11.7 0.62 2.54 x 1.27
(mW/cm2)2.0 semicircle
ISPTA0.3 0.0201 0.0162 3.79 2.40 11.7 0.62 2.54 x 1.27
(W/cm2)2.0 semicircle
Ultrasonic Output: TRIA™Vascular Doppler
Max MI WofcZsp x-6 (cm) EBD (cm)
Value (mW) (MHz) (cm) y-6 (cm)
ISPTA0.3 3.3 0.0448 7.1 5.20 1.1 0.3 0.94 x 0.47
(mW/cm2)0.75 semicircle
ISPTA0.3 0.0033 0.0448 7.1 5.20 1.1 0.3 0.94 x 0.47
(W/cm2)0.75 semicircle
Data for ultrasonic output tables reported as maximum value. Data for IEC
1157 table reported as maximum value plus 95% confidence interval.
The derated value of the acoustic intensities are calculated according to the fol-
lowing formula:
I0.3 = Iwexp(-0.069fczsp)
where I0.3 is the derated intensity in mW/cm2, Iwis the intensity measured in
water per NEMA UD-2, fcis the center frequency of the transducer in MHz, and
zsp is the location of the axial spatial peak in cm.
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Definition of Terms (Ultrasonic Output Tables)
**Note: The uncertainty in these measurements was calculated per
NEMA UD-2 Appendix A to be 24%.
ISPTA0.3 The derated spatial-peak, temporal-average intensity
(milliWatts per square centimeter)
ISPTA0.3 The derated spatial-peak, pulse-average intensity
(watts per square centimeter)
MI The Mechanical Index
WoThe ultrasonic power (milliWatts)
fc The center frequency (megaHertz)
Zsp The axial distance used to calculate the derated
intensity (millimeters)
EBD Entrance beam dimensions for the azimuthal and elevational
planes (centimeters)
x-6,y-6 Beam dimensions at spatial peak (cm)
PD Pulse Duration (microseconds)
PRF Pulse Repetition Rate (Hz)
Data for ultrasonic output tables reported as maximum value.
The derated value of the acoustic intensities are calculated according to the
following formula:
I0.3 = Iwexp(-0.069fczsp)
Where I0.3 is the derated intensity in mW/cm2, Iwis the intensity measured in
water per NEMA UD-2, fcis the center frequency of the transducer in MHz, and
zsp is the location of the axial spatial peak in cm.

Troubleshooting
Your MedaSonics Doppler System has been designed to a high level of quality
and reliability. If you should encounter a problem, however, this table lists some
possible solutions.
Symptom Possible Cause Remedy
No sound from loud • Battery low • Replace battery
speaker
• Improper connection • Reconnect
between probe and
speaker unit
• Volume control set • Turn up volume
too low
On LED does not light • Battery dead • Replace battery
when switched on
If the problem persists after trying the above suggestions, please contact
MedaSonics or your supplier.
Regulatory Compliance
Manufactured by Nexcore Technology Inc. and Distributed by MedaSonics, a
division of CooperSurgical. Nexcore is committed to producing the highest
quality Doppler systems. Nexcore has maintained certification to ISO
9001:1994, ANSI/ISO/ASQ Q9001-1994, and EN46001:1996.
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MEDASONICS®
User’s Manual
15 Forest Parkway • Shelton, CT 06484
(800)-227-8076 • (203)-929-6321
fax [phone]
www.coopersurgical.com
Part # 054-0223-010 Rev.C 10/01
Handheld Doppler