Echo Sounder

ES-101EX2 MHz

Fetal Doppler

Excellence in Human Service and Technology

Hayashi Denki Co., Ltd.

®

OPERATING MANUAL

* Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

* Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

* Clinical applications . . . . . . . . . . . . . . . . . . . . . 3

* Operating controls . . . . . . . . . . . . . . . . . . . . . . 4

* Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

* Detection of fetal heart beats . . . . . . . . . . . . . 8

* Replacing batteries . . . . . . . . . . . . . . . . . . . . . . 9

* Maintenance procedures . . . . . . . . . . . . . . . . 10

* Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

* Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 11

Table of Contents

101EX2 OM E-12October 3, 2003

Please read this manual carefully before you operate the unit.

OPERATIONAL PRECAUTIONS(FOR SAFETY AND HAZARD PREVENTION)

1. General

(1) Only skilled persons should operate the unit.

(2) Main unit

This equipment is not designed for sterile and underwateruse. Autoclaving or immersing in any liquid may damagethe parts.

The transducer tip is very thin and delicate. Please take carenot to drop the unit or hit the transducer.

Any connector must not be connected with a mains con-nected device.

(3) Ultrasound gel

Always use an ultrasound gel. Using other materials such asbaby oil and cream will not produce correct Dopplersounds, but may spoil the transducer.

The ultrasound gel (Doppler Jelly) enclosed is non-sterileand do not use it for surgeries.

Incidence of allergy: Discontinue use of gel if an allergicreaction occurs.

2. Before using the unit, take care of the following:

(1) Do not place near water or other liquid.

(2) Do not place where sunlight, dust, salt, sulfur and so forthwill affect the unit adversely.

(3) Do not place where chemicals are stored or gas may be gen-erated.

(4) Make sure that the unit operates safely and correctly byfollowing the maintenance procedures mentioned in thesection "Maintenance Procedures".

(5) Use the unit under the operating environments specified onthe Specifications.

(6) Use the Echo Sounder as specified in the operating manual.

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3. When operating the unit, take care of the following:

(1) Do not use the unit simultaneously with an electric cautery,cardioverter, other ultrasonic device or mobile phone.

(2) Be careful not to exceed time and volume which is neces-sary for diagnoses treatment.

(3) Always watch so the unit and patient are not under abnor-mal conditions.

(4) When any abnormality is found on the unit or the patient,take proper action such as stopping operating the unit in amanner safe to the patient.

4. After using the unit, take care of the following:

(1) Turn the power switch off, and disconnect all cables.

Do not apply excessive force to disconnect the cables suchas pulling them too strongly.

(2) For storage of the unit, take care of (1) to (5) of 2 in previ-ous page.

5. Repair services

(1) When the unit gets out of order, contact the dealer for re-pair from whom you purchased the unit.

(2) Only authorized persons should perform the repair ser-vices.

6. Do not remodel the equipment.

7. Maintenance and inspection

(1) Do the periodical inspection by following the proceduresmentioned in the section "Maintenance Procedures".

8. Destruction

(1) In case of destruction of the unit, follow the instructions fordisposition of the destruction appointed by each country orlocal government.

(2) Do not place battery in the fire. It will explode and can hurtyou.

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Thank you very much for purchasing Echo Sounder ES-101EX.

The Echo Sounder ES-101EX is a single-handed Doppler designed for thedetection of the fetal heart with the sounds and the heart rate display.Very simple operational controls (only 2 buttons), and light and compactunit allow you a comfortable single-handed operation. Noise canceller andpulsed Doppler technique are employed for clear and noiseless sounds.

Please read this manual carefully to acquaint yourself with the EchoSounder operation.

FEATURES

* Fetal Doppler with LCD displaysReal time fetal heart rate, low battery & heartbeat indicators

* Noise canceller and pulsed controlled depth

For clear and noiseless sounds

* Easy and safe to operateSafe and effective low-intensity beamFreeze button for heart rate observation

* Headset outputs (Headset optional)

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CLINICAL APPLICATIONS

* Convenient detection of fetal heart sounds

* Determination and display of fetal heart rate

* Monitor fetal heart rate during labor

* Verify fetal heart viability following patient trauma

OPERATING CONTROLS

1. LCD : Displays heart rate and following indicators.Heart rate is displayed based on a 4 beat aver-age once Echo Sounder gets sufficient data tocalculate. When calculated heart rate is notstable, the display will flashes.

Low battery indicator

Heartbeat indicator tracks heartbeatwhile in measurement.

Sound volume (High)

Sound volume (Low)

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1

2

3

4

5

6

7

Front view Rear view

2. Volume control button: To adjust sound volume in 2 steps.Press the button to change sound volume Highto Low or vice versa.

3. Power/Freeze button : To turn On/Off unit or freeze heart rate.Press the button longer than 2 sec to turn theunit Off.Press it less than 2 sec to freeze the data.

4. Transducer : To convert electric signals to ultrasonic signalsand vice versa.

5. Headset connector : To connect the headset, optional, to listen tothe Doppler sounds. The headset cuts off thespeaker.

6. Speaker : To hear Doppler sounds.

7. Battery cover : Refer to the section "Replacing Batteries" forfitting or replacing batteries.

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OPERATION

(1) Remove the battery cover and in-sert 2 batteries. See the section"Replacing Batteries" for the details.

(2) Turn the unit ON by pressingPower/Freeze button.

Note: If low battery indicator appears, replace the

batteries .

(3) Apply ultrasonic gel to the abdo-men.

(4) Put the transducer of the unit onthe abdomen at the right angle tothe skin surface, and slowly movethe unit to locate the point whereDoppler sounds are maximum.

Power/Freeze button

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Low battery indicator

Batterycover

Skin surface

Gel

(5) Press Volume control button toselect either High or Low soundlevel.

(6) At the start of the measurement,LCD flashes because the calculatedheart rate is not stable. When thecalculated heart rate becomes rea-sonably stable, LCD goes solid. Theheart rate displayed changes atapprox. 2 sec. intervals to track thefetal heart rate. Press Power/Freezebutton to freeze it.

(7) Headset (optional) can be used tolisten to Doppler sounds. It will cutoff the speaker.

WARNINGDo not connect the EchoSounderto a mains connected device,such as a tape recorder.

(8) Press Power/Freeze button longerthan 2 seconds to turn the unit off.

Note: If the unit is left on longer than 3 minutes

with no signal input, it will be automatically shut

off.

Headset connector

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Volume control button

Power/Freeze button

DETECTION OF FETAL HEARTBEATS

In the early stages of pregnancy, the search for fetal heart sound shouldbe concentrated directly above the symphysis pubis. Before 8th week ofpregnancy, the fetal sound often may not be heard.

However, to try is important. It may be occasionally necessary to inclinethe probe above and behind the bony structions of the pelvis to detect afetal heart sound from the 8th through 12th week of pregnancy.Searching the abdomen by quadrant is usually the most effective methodin the later stages of pregnancy.

FETAL DOPPLER SOUNDS

Two very distinguishable sounds can readily be detected from the preg-nant uterus.

a) The fetal heart beat is a mechanical "plop-plop" sound which var-ies somewhat according to the gestational age and the orientationof the fetal heart in relation to the sound beam from the transmit-ter.

b) The cord signal is a "swishing" type of sound that resembles thesound from other large arteries. The cord signal pulsates at thefetal heart rate.

The sound of maternal artery can be easily differentiated from that of theumbilical cord since maternal arteries pulsate at the maternal heart ratewhile the umbilical cord pulsates at the fetal heart rate.

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REPLACING BATTERIES

(1) When low battery indicator appearsat the upper left of the LCD, replacebatteries with new ones at the firstpossible moment.

(2) Turn the unit off and remove thebattery cover.

(3) Prepare of new 2 pcs. AA alkalinebatteries. Non-alkaline batteriesmay cause a short of power.

(4) Set the new batteries ensuring thepolarity of the batteries corre-sponds to each of "+" and "-" signsdescribed inside of the batterycompartment.

WARNINGDo not dispose of batteries in fireor recharge, this can cause themto explode.

CAUTIONIf not using the unit for a longtime, remove the batteries.

Low battery indicator

Batterycover

WARRANTY

This equipment is guaranteed for the period of one year after the date ofpurchase when used under normal conditions.In the event of any trouble during the warranty period, please contact thedealer from who you purchased the unit, who will service free accordingto the service provision.In case the warranty period is over, please consult the dealer for acharged service.

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MAINTENANCE PROCEDURES

Please perform the maintenance before use and in case the unit is notused for a while.

Checking(1) Check if appearance of main unit and accessories are not damaged.(2) Shake the unit and make sure if there are no sounds inside from

internal components coming out.(3) Turn the unit on and make sure if LCD works properly.(4) Pat the transducer to check if sounds come out from speaker.

CleaningRemove the Doppler gel from the transducer after use. Clean the unitusing damp cloth and then wipe with a soft dry cloth, but take great carethat any water may not penetrate into the unit.If using disinfectant, please consult in advance with the manufacturer.

CAUTIONDo not use an autoclave or other high-temperature steril-izing methods.

SPECIFICATIONS

Transducer : 2.25 MHz, dia. 20 mm

Ultrasonic power : 2.78 mW/cm2 (Ispta*, in situ)* Ispta : Spatial Peak-Temporal Average Intensity

Power source : DC 3 V, AA alkaline batteries (1.5 V x 2 pcs.)

Battery life : 5 hours or more (sound volume at maxi-mum)

Automatic shut-off : No signal: 3 min.

Max speaker output : Approx. 250 mW

Heart rate range : 60 to 240 bpm, accuracy : ±3 %

LCD display: Heart rate (4 beat average)Sound volume, heartbeat and low batteryindicators.

External output : Headset (3.5 mm jack)

Operating environment: 10 to 40 degrees Centigrade85% humidity or less with no condensation

Storage and transport 0 to 50 degrees Centigradeenvironment: 85% humidity or less with no condensation

Dimensions : 52 (W) x 135.5 (D) x 30 (H) mm

Weight : Approx. 150 grams (including batteries)

Electrical safety : Conform to IEC-60601-1Equipment with an INTERNAL ELECTRICALPOWER SOURCEType BF device applied part

ACCESSORIESACCESSORIESACCESSORIESACCESSORIESACCESSORIES : Ultrasonic gel . . . . . . . . . . . . 1AA alkaline batteries . . . . . . . 2Carrying bag . . . . . . . . . . . . . 1

OPTIONOPTIONOPTIONOPTIONOPTION : Headset

* Specifications subject to change.

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Hayashi Denki Co., Ltd.7-11 Arima 2-chome, Miyamae-ku, Kawasaki, 216-0003 Japan

®

101EX2 OM E-12Printed in Japan

October 3, 2003080-00062