GTIN

: 008

9491

2002

050

PRECAUTIONSPROBE

Non-invasive probes are for transcutaneous use only

Probe transducer tips are thin and delicate. Be careful not to drop or hit the probe tip. After use, protect the transducer with the probe cap.

ULTRASOUND GELUse ultrasound gel. Use of other materials such as baby oil and cream may not produce correct Doppler sound, and may damage the probe.

Not recommended with patients having a sensitivity or allergic reaction to ultrasound gel.

BATTERYWhen battery is low, the power indicator will flash. Replace the battery.

Use only 9-volt alkaline batteries. A non-alkaline battery may cause a shortage of power.

When not using the unit for a long period of time, remove the battery.

MAIN UNITDo not place near water or other liquid, where atmospheric pressure, ventilation, sunlight, dust, salt, sulfur, etc. may cause damage, or where chemicals are stored or gas may be generated.

Use in environments where temperature is between 10° - 40° C and humidity is less than 75%.

Protect the unit from vibration and shock during transport.

Keep more than 1.5 meters away from computers or other information equipment.

Make sure that there is no damage to the unit or probe before use.

Do not use simultaneously with an electro cautery defibrillator or other ultrasound device.

Please do not use the Doppler continuously for more than 1 hour to avoid the possibility of skin irritation or rash.

The Doppler box should not have direct patient contact or be placed in the sterile field as it cannot be sterilized and reprocessed. If contact occurs, please see cleaning instructions for cleaning the Doppler box.

The Doppler box and non-invasive probes should be cleaned following any patient contact

CAUTION: The ES-100VX has not been evaluated for safety and compatibility in the MR environment. The ES-100VX has not been tested for heating or migration in the MR environment.

CAUTION: Perform ultrasound testing/procedures prudently using the principle of ALARA (As Low As Reasonably Acheivable)

TABLE OF CONTENTSES-100VX MiniDoppler®

INTRODUCTION 1

CLINICAL APPLICATIONS ................................................................................2

CONTROLS ................................................................................................…3-4

REPLACING THE BATTERY .........................................................................…5

TURNING THE UNIT ON & OFF .......................................................................5

OPERATION ................................................................................................... 6-7

PROBE SELECTION ..........................................................................................8

PRINCIPLES .......................................................................................................9

BLOCK DIAGRAM ............................................................................................10

SPECIFICATIONS .............................................................................................11

CLEANING ........................................................................................................12

WARRANTY ......................................................................................................12

SAFETY STANDARDS ............................................................................... 13-15

1

Thank you for choosing the ES-100VX MINIDOPPLER® …The ES-100VX MiniDoppler® has four non-invasive interchangeable probe frequencies of 2.25, 5, 8, and 10 MHz for detection of arterial and venous blood flow in the lower extremities. The 2.25 MHz focused probe is for fetal heart rate measurement.

FEATURES

• Pocketable, hand-held size• Great sensitivity• Wideprobeselectionforuserflexibility• Convenient probe activation button• Automatic power “off”

MiniDoppler is a registered trademark ® of Koven Technology, Inc., St. Louis, MO

ES-100VX MiniDoppler®

2

CLINICAL APPLICATIONS

The ES-100VX can be used for the following clinical applications:

• Fetal heart sounds• Peripheral vascular procedures• Pedal pulse checks• Blood pressure segmental studies• Venous compression studies

ES-100VX MiniDoppler®

3

CONTROLSFront Panel

1) PROBE CONNECTOR To connect the probe to the Doppler

2) HEADSET CONNECTOR To connect a headset (not provided)

3) VOLUME CONTROL To adjust the sound volume

4) POWER INDICATOR Indicates power ON/OFF

5) SPEAKER Outputs Doppler sound

ES-100VX MiniDoppler®

4

6) PROBE HOLDER For probe placement when not in use

7) STRAP HOLES To connect the carry strap

8) BATTERY COVER See “Replacing the battery” on page 5

9) PROBE Choose from 2.25, 5, 8 & 10 MHz frequencies (8 MHz vascular & 2.25 MHz fetal

are most common)

10) PROBE BUTTON Activates the ES-100VX

11) PROBE CAP Protects the probe tip when not in use

CONTROLSRear Panel

ES-100VX MiniDoppler® 3. REPLACING THE BATTERIES

5

REPLACING THE BATTERY

Press down on the battery cover and slide in the direction of the arrow, as pictured on the right.

Place a 9-volt alkaline battery in the unit, making sure that the positive and negative electrodes correspond to the + and – marks on the label inside the battery box.

Replace the battery when the power indicator LED flashes.

TURNING THE UNIT ON & OFF1. TURNING THE UNIT ON

Connect the probe with the arrow on the probe connector pointing up (12 o’clock position) and press the probe button to turn the unit ON.

Turn the volume control to the desired level.

2. TURNING THE UNIT OFF

Press the probe button a second time to turn the unit OFF.

3. AUTOMATIC POWER OFF

If the unit is left on while not in use, the power will be automatically shut off after approximately 3 minutes.

NOTE: Use only 9-volt alkaline batteries. Use of non-alkaline batteries may cause a shortage of power.

NOTE: The auto-off time is dependent on room temperature.

ES-100VX MiniDoppler® OPERATION

1. Connect the probe to the ES-100VX with the arrow on the

probe connector pointing up (12 o’clock position).

2. Place ultrasonic gel on the probe tip or the patients skin. Make sure there is enough gel to cover the tip of the probe.

Press the probe button to turn the unit on.

3. Make sure the power indicator on the unit is lit.

Turn the volume control to the desired level.

6

ES-100VX MiniDoppler®

7

OPERATION (cont.)4. Place the probe on the skin and

move slowly to locate the point where maximum Doppler sounds are heard (see below for your probe type).

[Pencil Style Probe] If using the pencil style probe, hold the

probe softly against the measurement area at an angle of approximately 45 to 60 degrees to the skin surface (see figure A)

[Flat Vascular Probe (Model BF8)] If using the flat vascular probe, place the

probe over the artery, adjust to locate the best sounds, and affix in place using the velcro strap provided (see figure B).

[Fetal Probe (Model BT2M20S8C)] When using the 2 MHz probe for fetal

heart beat detection, place the probe on the measurement area at a 90 degree angle (see figure C) and move slowly to locate the point where fetal heart sounds are at the maximum.

Figure A

Figure B

Figure C

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PROBE SELECTION

The frequency of diagnostic ultrasound is inversely proportional to depth of penetration. The ES-100VX has 4 interchangeable non-invasive probes with different frequencies.

Probe selection depends on the application.

BT2M20S8C (2.25 MHz) (GTIN# 00894912002326): Fetal heart beat & soundsBT5M05S8C (5 MHz) (GTIN# 00894912002326): Deep peripheral blood flowBT8M05S8C (8 MHz) (GTIN# 00894912002326): Superficial blood flow (most commonly used)BF8M15S8A (8 MHz) (GTIN# 00894912002296): Superficial blood flow (flat probe)BT10M5S8C (10 MHz) (GTIN# 00894912002326): Superficial blood flow

APPLICATIONS

1. Detection of Fetal Heart Sounds

Probes to be used: BT2M20S8C (2.25 MHz)

Evaluation of fetal heart beat & sounds throughout pregnancy except where fetal heart is not developed sufficiently during the first trimester.

2. Detection of Arterial & Venous Blood Flow

Probes to be used: BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) (most commonly used) BF8M15S8A (8 MHz) (flat probe) BT10M5S8C (10 MHz)

ES-100VX MiniDoppler®

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PRINCIPLES

The ES-100VX MiniDoppler® is designed to receive blood flow velocity information through the use of ultrasound. A specific frequency is transmitted from the probe to the patient.

The transceiver amplifies a high frequency oscillation output for transmission to the transducer. The voltage is converted by piezoelectric crystal (transducer) to ultrasound. The ultrasound beam is transmitted to blood cells flowing through arteries or to beating fetal hearts. The ultrasound beam is reflected by the red blood cells or by moving structures and received by the crystal in the transducer, which converts the ultrasound into a voltage. A Doppler shift occurs between the emission and reception of the ultrasound beam.

The voltage is amplified. The electronics amplify the signal, filters out noise and improves the S/N ratio. The Doppler shift signals are amplified further and converted to audible sound via the integrated speaker.

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ES-100VX MiniDoppler®

11

SPECIFICATIONS

Probes: Model Freq. Multiple frequencies BT2M20S8C 2.25 MHz BT5M05S8C 5 MHz BT8M05S8C 8 MHz BT10M5S8C 10 MHz BF8M15S8A 8 MHz (flat)

Battery: DC 9-volt, alkaline batteryBattery life: Approximately 3 hours (alkaline)Automatic shut-off: No signal: 3 min.Probe button: Power ON/OFFSpeaker output: 300 mW or moreExternal outputs: Headset: Cuts off sound from the speaker (3.5 mm jack)Dimensions: Main unit: 78(W) x 141(D) x 27(H) mm Probe: 20(Diam) x 105(L) mmWeight: Approx. 270 grams (including battery & probe)Operating Environment: 10 - 40 degrees Centigrade (50 – 104 degrees Fahrenheit) 85% humidity or less with no condensationStorage and transportEnvironment: 0 - 50 degrees Centigrade (32 – 122 degrees Fahrenheit) 85% humidity or less with no condensationElectrical safety: Conform to IEC-60601-1

Equipment with an INTERNAL ELECTRICAL POWER SOURCE

Type BF applied part.

Accessories: Carrying case Ultrasonic gel

9-volt battery Carry strap

Optional Accessories: Doppler rollcart (CT-1)Not made with natural rubber latex

* Specifications are subject to change

ES-100VX MiniDoppler® CLEANING

DOPPLER BOXES AND NON-INVASIVE PROBES

The Doppler box and probe can be wiped down using warm water, enzymatic cleaner, or alcohol with a damp soft cloth after use. If an enzymatic cleaner is used, wipe down again using warm water or alcohol with a damp soft cloth. Hospital approved alcohol based wipes are an acceptable alternative to a damp soft cloth.

Caution: Do not submerge Doppler box or probe in any liquid.

WARRANTYThe Doppler box is warrantied for a period of 2 years from the date of purchase when used under normal conditions. Warranty periods on probes, adaptors & accessories vary. Please refer to your purchase invoice for additional warranty terms.

In the event of an equipment malfunction during the warranty period, please contact Koven Technology, Inc. at 800-521-8342 or info@koven.com. The warranty does not cover defects resulting from accidents or misuse and is void if modifications or repairs are attempted without permission.

In case the warranty period has expired, please consult Koven Technology, Inc. for a charge service.

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ES-100VX MiniDoppler® SAFETY STANDARDSThe ES-100VX conforms to the following standards:

Guidance and manufacturer’s declaration - electromagnetic emissions and immunity

Guidance and Manufacturer’s Declarations

Electromagnetic EmissionsThe ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment.

Emissions test compliance Electromagnetic environment - guidanceRF emissions Group 1 The ES-100VX uses RF energy only for its internal function. Therefore, the RF emissions are very low andCISPR 11 are not likely to cause any interference in nearby electronic equipment.RF emissions Class A The ES-100VX is suitable for use in all establishments other than domestic, and may be used connected to theCISPR 11 public low-voltage power supply network that suppliesHarmonic Not Applicable buildings used for domestic purposes. IEC61000-3-2 Voltage Not Applicable fluctuations/ flicker emissions IEC61000-3-3

13

ES-100VX MiniDoppler® Guidance and Manufacturer’s Declarations (cont.)

Electromagnetic ImmunityThe ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment.

Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic ± 6kV contact ± 6kV contact Floors should be wood, discharge (ESD) concrete or ceramic tile. If ± 8kV air ± 8kV air floors are covered with IEC61000-4-2 synthetic material, the relative humidity should be at least 30%.Electrical fast ± 2kV for power Not Applicable transient/burst supply lines IEC61000-4-4 ± 1kV for input/output lines Surge ± 1kV differential Not Applicable mode IEC61000-4-5 ± 2kV common mode Voltage dips, short < 5% UT Not Applicable interruptions and (> 95% dip in UT) voltage variations for 0,5 cycles on power supply 40% UT input lines (60% dip in UT) for 5 cycles IEC61000-4-11 70% UT (30% dip in UT) for 25 cycles

< 5% UT (> 95% dip in UT) for 5 s Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hz) fields should be at levels magnetic field characteristic of a typical IEC61000-4-8 location in a typical commercial or hospital environmentNOTE UT is the a.c. mains voltage prior to application of the test level.

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ES-100VX MiniDoppler®

15

Guidance and Manufacturer’s Declarations (cont.)

Electromagnetic Immunity (cont.)The ES-100VX is intended for use in the electromagnetic environment specified below. The user of the ES-100VX should assure that it is used in such an environment.

Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the ES-100VX, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter

Recommended separation distance Conducted RF 3Vrms 3V d = 1,2√PIEC61000-4-6 150 kHz to 80 MHz

Radiated RF 3V/m 3V/m d = 1,2√P 80 to 800 MHzIEC61000-4-3 80 MHz to 2.5 GHz d = 2,3√P 800MHz 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 strength 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

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, 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 theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ES-100VX is used exceeds the appli-cable RF compliance level above, the ES-100VX should be observed to verify normal operation. If abnormal perfor-mance is observed, additional measures may be necessary, such as reorienting or relocating the ES-100VX

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m

OM-1155Copyright © Koven Technology, Inc., St. Louis, MO

Koven Technology, Inc.477 N. Lindbergh Blvd., Suite 220

St. Louis, MO 63141Tel: 800-521-8342 • Fax: 314-542-6020

E-mail: info@koven.comwww.koven.com

GLN: 0894912002005