CooperSurgical MedaSonics TRIA II TR150 Series, MedaSonics TRIA II TR250 Series, TSP-8, CTP-2, CTP-3 User Manual

Fetal and Vascular Dopplers

User Manual for TR150 Series Units (Non-Display)
and TR250 Series Units (Display)

®

Thank you for choosing TRIA® II from CooperSurgical, Inc. MedaSonics® handheld
Dopplers have been a standard of care for 30 years. 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: Page

Intended Use/Contraindications/Warnings..............1

Description of Product.............................................3

Operation and Installation........................................5

Obtaining Doppler Signals.......................................8

Maintenance and Cleaning......................................10

Replacing Batteries.................................................11

Troubleshooting.......................................................12

Clinical References.................................................13

Accessories.............................................................13

Specications..........................................................14

Warranty and Servicing Policy.................................17

Explanation of Symbols...........................................Back Cover

Please read the manual carefully and become familiar with the operation, features and
maintenance of your Doppler prior to using the device or accessories.

Warranty and Servicing Policy

This warranty is in lieu of all other warranties, expressed or implied. CooperSurgical
warrants this TRIA

Parts- CooperSurgical will repair or replace parts in exchange for defective parts for the

specied life of the device of ve (5) years after date of original purchase with no charge

for the parts. CooperSurgical reserves the right to determine whether a part should be
repaired or replaced.

Labor- CooperSurgical will repair this instrument with no labor charge for a period of one
(1) year after the date of original shipment when it is shipped to the CooperSurgical 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 purpose 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 CooperSurgical. CooperSurgical makes no warranty of the results to be obtained.
CooperSurgical’s 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. Preventive maintenance, the renishing 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. CooperSurgical will not be responsible for any
loss, damage or injury resulting from delay in rendering service under this warranty.
COOPERSURGICAL 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 specic legal rights, and you may also have other rights which vary from state to state.

To return products to CooperSurgical:

1. Call CooperSurgical for any nal instructions prior to shipping

2. Clean the product prior to shipping

3. Ensure the device is well-packaged and suitable for shipment

4. Send the product to:
Service Center
CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA

For Service and Repair, please call: [phone] or [phone] for international calls.

Year of manufacture
is located on the device.

Here’s how you can reach us...
Phone: [phone]
Fax: [phone]

International
Phone: [phone]
Fax: [phone]

visit our website at: www.coopersurgical.com

CooperSurgical, Inc.
95 Corporate Drive
Trumbull, CT 06611 USA

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 (5 and 8 MHz Probes)

This product will be used to detect blood ow in veins and arteries for assisting in the detection of

peripheral vascular disease.

Caution

• U.S. Federal law restricts this device to sale by or on the order of a licensed practitioner.

Contraindications

Warnings

• The vascular probes (5 and 8 MHz) are not for fetal use.

• The ultrasound probes are not to be used on or near the eyes.

• The device is for use only on intact skin.

• Do not plug any part of this device into a telephone jack or modem system.

• This device is not intended for use simultaneously with HF surgical equipment.

If there are questions or concerns regarding these warnings or contraindications, please do not

hesitate to contact CooperSurgical for further clarication.

Caution

• Dropping the TRIA® II probe or accessories may cause damage to the housing or electronics.

Safety of Ultrasound

The Tria® II was 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.

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 (WEEE) as unsorted municipal waste. Contact local
WEEE disposal sites.

1

The following ofcial statements from the American Institute of Ultrasound Medicine (AIUM)

are provided for your general information regarding the safe use of ultrasound.

Clinical Safety

Approved March 1997, October 1982

Diagnostic ultrasound has been in use since the late 1950s. Given its known benets and
recognized efcacy for medical diagnosis, including use during human pregnancy, the

American Institute of Ultrasound in Medicine herein addresses the clinical safety of such
use:

There are no conrmed biological effects on patients or instrument operators caused by

exposures from present diagnostic ultrasound instruments. Although the possibility exists

that such biological effects may be identied in the future, current data indicate that the
benets to patients of the prudent use of diagnostic ultrasound outweigh the risks, if any,

that may be present.

Prudent Use

Approved May 1999

The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly
discourages the non-medical use of ultrasound for psychosocial or entertainment purposes.
The use of either two-dimensional (2D) or three-dimensional (3D) ultrasound to only view
the fetus, obtain a picture of the fetus or determine the fetal gender without a medical
indication is inappropriate and contrary to responsible medical practice. Although there are

no conrmed biological effects on patients caused by exposures from present diagnostic
ultrasound instruments, the possibility exists that such biological effects may be identied in
the future. Thus ultrasound should be used in a prudent manner to provide medical benet

to the patient.

Safety in Training and Research

Approved March 1997, March 1983

Diagnostic ultrasound has been in use since the late 1950s. There are no conrmed

adverse biological effects on patients resulting from this usage. Although no hazard

has been identied that would preclude the prudent and conservative use of diagnostic

ultrasound in education and research, experience from normal diagnostic practice may
or may not be relevant to extended exposure times and altered exposure conditions. It is
therefore considered appropriate to make the following recommendation:

In those special situations in which examinations are to be carried out for purposes other

than direct medical benet to the individual being examined, the subject should be informed

of the anticipated exposure conditions, and of how these compare with conditions for
normal diagnostic practice.

Transducer Model: TSP-5 Operating Mode: Continuous-Wave (cw)
Application(s): Peripheral Vascular

ACOUSTIC OUTPUT MI I
(mW/cm

Global Maximum Value 0.04 223 0.22

Associated
Acoustic
Parameter

P

r.3

(Mpa) 0.09

Wo (mW) 12.8 0.013

fc (MHz) 5.3 5.3 5.3

Zsp (cm) 0.85 0.85 0.85

X

y

Az (cm) 0.4

Ele. (cm) 0.8

Beam Dimensions

EBD

Transducer Model: TSP-8 Operating Mode: Continuous-Wave (cw)
Application(s): Peripheral Vascular

ACOUSTIC OUTPUT MI I
(mW/cm

Global Maximum Value 0.03 229 0.23

Associated
Acoustic
Parameter

P

r.3

(Mpa) 0.09

Wo (mW) 13.9 0.014

fc (MHz) 8.0 8.0 8.0

Zsp (cm) 0.66 0.66 0.66

X

y

Az (cm) 0.3

Ele. (cm) 0.6

Beam Dimensions

EBD

2

Description of Product

The MedaSonics TRIA® II Doppler includes user interchangeable ultrasound transducers to

meet your specic needs. Other features include:

Main Unit

The main handheld unit is ergonomically designed to t the palm of your hand with

comfort and allow easy access to each control feature. Each unit is individually tested and
inspected to ensure the highest quality standards.

SSQ – Superior Sound Quality. Every TRIA® II Doppler is designed with a state of the art
sound system that produces excellent sound quality and long-term reliability.

LCD Display – The LCD display (TR250 only) allows you to view the fetal heart rate in
large, easy to read digits, monitor battery life, observe signal strength indicators, and view
multiple diagnostic indicators to ensure your unit is functioning at peak performance levels.

Non-display units (TR150 models) incorporate LED indicators for battery status.

314

Radio Frequency Interference
The TRIA® II was tested for immunity to electromagnetic interference at a level of 3V/meter.

Interference during normal operation may occur in the presence of elds stronger than 3V/

meter. If this occurs, try to increase the distance between the TRIA
interference. Contact CooperSurgical for more information.

Diagnostic Codes – Contact CooperSurgical’s Service Dept. at 1-800-444-8456

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

Reference materials for Obstetrical and Peripheral Vascular testing:

Handbook of Fetal Heart Rate Monitoring; Julian T. Parer, 1997

Doppler Ultrasound and Its Use In Clinical Measurement; Peter Atkinson and John P.
Woodcock, 1982

Noninvasive Diagnosis of Peripheral Vascular Disease; W. Robert Felix, Jr., 1988

Current Noninvasive Vascular Diagnosis; Ali F. Aburahma, Edward B. Diethrich, 1988

Accessories

To order accessories (gel, batteries, probe cleaner, cables), please contact CooperSurgical.

Probes

TRIA® II ultrasound transducers were designed to meet your specic applications needs.
Each probe has been ergonomically designed for comfort while providing excellent
maneuverability for locating the fetus or vascular target.

Each 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. Waterproof
versions of the 2 MHz probe are available.

3 MHz – Early 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.

5 MHz – This standard “pencil” style probe is an excellent vascular tool for locating deep

specic 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 – This standard “pencil” style probe is an excellent vascular tool for locating shallow

specic vessels in the peripheral vascular system. The narrow grip and small face of the

probe make it ideal for maneuvering for maximizing the signal. Sterilizable versions of the
8 MHz probe are available.