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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 flow 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 clarification.

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.

I

SATA

 

 the 

spatial-average temporal-average intensity (mwatts per cm

2

).

I

SPTA.3

 

   the 

derated spatial-peak temporal-average intensity (mwatts per cm

2

).

I

SPPA.3

 

 the 

derated spatial-peak pulse-average intensity (watts per cm

2

).

MI

 the 

Mechanical Index.

P

r.3

 

 the 

peak rarefactional pressure

 (megapascals) associated with the transmit pattern giving 

rise to the value reported for MI.

W

o

 

the total time-average 

ultrasonic power 

(mwatts).

f

c

 

the probe 

center frequency

 (MHz).

Z

sp

 

the 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).

EBD

 

 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 (

I

w

) at a depth of z 

calculated by:

I

.3

 = exp(-0.23*0.3*f*z)*

I

w

(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:

P

r.3

 = exp(-0.115*0.3*f*z)*

p

r

(where pressure is given in megapascals)

Additional Output Reporting Information for IEC 61157
5 MHz: 

I

ob

 < 51 mW/cm

2

8 MHz: 

I

ob

 < 47 mW/cm

2

The 2 MHz, 2 MHz WP and 3 MHz obstetrical probes are exempt from the declaration requirements of 
IEC 61157.  These probes meet the conditions: 

I

ob

 < 20 mW/cm

2

I

spta

 < 100 mW/cm

2

, and  

P

< 1 MPa.  

I

ob

 is output power divided by beam area.  

Note that parameter 

Z

sp

 in the probe reporting tables is the same parameter as 

I

p

 in IEC 61157.

Obstetrical Probe Information: 

I

SATA (max)

 (mW/cm

2

)                     19.6              17.0

P

o

 (mW)                                        48.0              24.4

Effective Radiating Area (cm

2

)     2.45             1.57 

Ultrasound Frequency (MHz)       2.1 MHz      3.2 MHz 

Pulse Duration                              CW              CW 

Repetition Freq.                            CW              CW 

Model Number 

    CTP-2             CTP-3

    CTP-W 

1

16

Summary of Contents for CTP-2

Page 1: ...EUROPE gracht 20 he Hague rlands e USA Fetal and Vascular Dopplers User Manual for TR150 Series Units Non Display and TR250 Series Units Display man e ...

Page 2: ...ccessories 13 Specifications 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 Warra This wa warran Parts specifie for the repaire Labor 1 yea Center purcha Limitat indicat shall no by Coo Cooper terms s but not shippin or neg...

Page 3: ...e questions or concerns regarding these warnings or contraindications please do not hesitate to contact CooperSurgical for further clarification 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 reduce...

Page 4: ...cture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments the possibility exists that such biological effects may be identified in the future Thus ultrasound should be used in a prudent ma...

Page 5: ... 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 indi...

Page 6: ...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 specific vessels i...

Page 7: ...al g rtment 5 Operation and Installation On Off Button Probe Clip Doppler Cable Connector Head Phone Connector Battery Compartment Door Belt Clip Volume Slider ...

Page 8: ...at 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...

Page 9: ...ge the batteries soon after the current examination is complete Non display units TR150 use the On Off LED 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 ...

Page 10: ...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...

Page 11: ...ailable 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 th...

Page 12: ...y close attention to clean the seams along the plastic lines at the probe face but do not allow water or spray to enter through the connectors or speaker grill To disinfect unit use commercially available spray or wipe disinfectants registered with the EPA Clorox Broad Spectrum Quaternary Disinfectant is the only disinfectant that is CooperSurgical approved for use with the TRIA II product Follow ...

Page 13: ...ist in lifting the batteries out 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 hav...

Page 14: ...eaker may cause poor sound Device damage from dropping the TRIA II probes or accessories Heart Rate 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 Ensure by manual counting that the rate is between 50 and 220 BPM Battery indicator flashing Consult the Battery Monitoring section replace batte...

Page 15: ... 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 Diagnosi...

Page 16: ...60601 1 4 IEC 60601 2 37 EN55011 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 Battery type and voltage 3 AA Alkaline 1 5 volt for non rechargeable units 3 AA NiMH 1 5 volt for rechargeable units as applicable Battery life Batteries provid...

Page 17: ...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 6 cm 0 4 0 4 y 6 cm 0 6 0 6 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 ISPTA 3 ISPPA 3 mW cm2 W cm2 Global Maximum Value 0 03 229 0 23 Associated Acoustic Parameter Pr 3 Mpa 0 09 Wo mW 13 9 0 014 fc MHz 8 0 8 0 8 0 Zsp cm...

Page 18: ...ut 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 r...

Page 19: ...uct 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 refinishing or replacement of any cosmetic defect or deterioration or the replacement of batteries u...

Page 20: ...ered trademark of The Clorox Company Reorder Number Consult instructions for use U S Federal law restricts this device to sale by or on the order of a physician Date of Manufacture Serial Number Not made with natural rubber latex Authorized Representative in the European Community Manufacturer In order to preserve protect and improve the quality of the environment protect human health and utilize ...

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