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OPERATING MANUAL

Echo Sounder

ES-101EX
2 MHz

Fetal Doppler

Excellence in Human Service and Technology

Hayashi Denki Co., Ltd.

Table of Contents
* Cautions

..............................1

* Features

..............................3

* Clinical applications
* Operating controls
* Operation

.....................3
......................4

.............................6

* Detection of fetal heart beats


* Replacing batteries

......................9

* Maintenance procedures
* Warranty
* Specifications

.............8

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101EX2 OM E-12
October 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 underwater
use. Autoclaving or immersing in any liquid may damage
the parts.
The transducer tip is very thin and delicate. Please take care
not to drop the unit or hit the transducer.
Any connector must not be connected with a mains connected device.

(3)

Ultrasound gel
Always use an ultrasound gel. Using other materials such as
baby oil and cream will not produce correct Doppler
sounds, but may spoil the transducer.
The ultrasound gel (Doppler Jelly) enclosed is non-sterile
and do not use it for surgeries.
Incidence of allergy: Discontinue use of gel if an allergic
reaction 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 forth


will affect the unit adversely.

(3)

Do not place where chemicals are stored or gas may be generated.

(4)

Make sure that the unit operates safely and correctly by


following the maintenance procedures mentioned in the
section "Maintenance Procedures".

(5)

Use the unit under the operating environments specified on


the Specifications.

(6)

Use the Echo Sounder as specified in the operating manual.

-1-

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 necessary for diagnoses treatment.

(3)

Always watch so the unit and patient are not under abnormal conditions.

(4)

When any abnormality is found on the unit or the patient,


take proper action such as stopping operating the unit in a
manner 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 such
as pulling them too strongly.

(2)

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

5. Repair services
(1)

When the unit gets out of order, contact the dealer for repair from whom you purchased the unit.

(2)

Only authorized persons should perform the repair services.

6. Do not remodel the equipment.


7. Maintenance and inspection
(1)

Do the periodical inspection by following the procedures


mentioned in the section "Maintenance Procedures".

8. Destruction
(1)

In case of destruction of the unit, follow the instructions for


disposition of the destruction appointed by each country or
local government.

(2)

Do not place battery in the fire. It will explode and can hurt
you.

-2-

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


The Echo Sounder ES-101EX is a single-handed Doppler designed for the
detection of the fetal heart with the sounds and the heart rate display.
Very simple operational controls (only 2 buttons), and light and compact
unit allow you a comfortable single-handed operation. Noise canceller and
pulsed Doppler technique are employed for clear and noiseless sounds.
Please read this manual carefully to acquaint yourself with the Echo
Sounder operation.

FEATURES
* Fetal Doppler with LCD displays
Real time fetal heart rate, low battery & heartbeat indicators
* Noise canceller and pulsed controlled depth
For clear and noiseless sounds
* Easy and safe to operate
Safe and effective low-intensity beam
Freeze button for heart rate observation
* Headset outputs (Headset optional)

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

-3-

OPERATING CONTROLS
Front view

Rear view
6

1
5
2

1. LCD :

Displays heart rate and following indicators.


Heart rate is displayed based on a 4 beat average once Echo Sounder gets sufficient data to
calculate. When calculated heart rate is not
stable, the display will flashes.

Low battery indicator

Heartbeat indicator tracks heartbeat


while in measurement.

Sound volume (High)

Sound volume (Low)

-4-

2. Volume control button: To adjust sound volume in 2 steps.


Press the button to change sound volume High
to 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 the
unit Off.
Press it less than 2 sec to freeze the data.

4. Transducer :

To convert electric signals to ultrasonic signals


and vice versa.

5. Headset connector :

To connect the headset, optional, to listen to


the Doppler sounds. The headset cuts off the
speaker.

6. Speaker :

To hear Doppler sounds.

7. Battery cover :

Refer to the section "Replacing Batteries" for


fitting or replacing batteries.

-5-

OPERATION
(1)

Remove the battery cover and insert 2 batteries. See the section

Battery
cover

"Replacing Batteries" for the details.

(2)

Turn the unit ON by pressing


Power/Freeze button.

Note: If low battery indicator appears, replace the


batteries .

Power/Freeze button

(3)

Apply ultrasonic gel to the abdomen.

Low battery indicator

(4)

Put the transducer of the unit on


the abdomen at the right angle to
the skin surface, and slowly move
the unit to locate the point where

Gel

Doppler sounds are maximum.

Skin surface

-6-

(5)

Press Volume control button to


select either High or Low sound
level.

Volume control button


(6)

At the start of the measurement,


LCD flashes because the calculated
heart rate is not stable. When the
calculated heart rate becomes reasonably stable, LCD goes solid. The
heart rate displayed changes at
approx. 2 sec. intervals to track the

Power/Freeze button

fetal heart rate. Press Power/Freeze


button to freeze it.
(7)

Headset (optional) can be used to


listen to Doppler sounds. It will cut
off the speaker.

WARNING
Do not connect the EchoSounder
to a mains connected device,
such as a tape recorder.
Headset connector
(8)

Press Power/Freeze button longer


than 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.

-7-

DETECTION OF FETAL HEARTBEATS


In the early stages of pregnancy, the search for fetal heart sound should
be concentrated directly above the symphysis pubis. Before 8th week of
pregnancy, the fetal sound often may not be heard.
However, to try is important. It may be occasionally necessary to incline
the probe above and behind the bony structions of the pelvis to detect a
fetal heart sound from the 8th through 12th week of pregnancy.
Searching the abdomen by quadrant is usually the most effective method
in the later stages of pregnancy.

FETAL DOPPLER SOUNDS


Two very distinguishable sounds can readily be detected from the pregnant uterus.
a) The fetal heart beat is a mechanical "plop-plop" sound which varies somewhat according to the gestational age and the orientation
of the fetal heart in relation to the sound beam from the transmitter.
b) The cord signal is a "swishing" type of sound that resembles the
sound from other large arteries. The cord signal pulsates at the
fetal heart rate.
The sound of maternal artery can be easily differentiated from that of the
umbilical cord since maternal arteries pulsate at the maternal heart rate
while the umbilical cord pulsates at the fetal heart rate.

-8-

REPLACING BATTERIES

Low battery indicator

(1)

When low battery indicator appears


at the upper left of the LCD, replace
batteries with new ones at the first
possible moment.

(2)

Turn the unit off and remove the


battery cover.

Battery
cover
(3)

Prepare of new 2 pcs. AA alkaline


batteries. Non-alkaline batteries
may cause a short of power.

(4)

Set the new batteries ensuring the


polarity of the batteries corresponds to each of "+" and "-" signs
described inside of the battery
compartment.

WARNING
Do not dispose of batteries in fire
or recharge, this can cause them
to explode.

CAUTION
If not using the unit for a long
time, remove the batteries.

-9-

MAINTENANCE PROCEDURES
Please perform the maintenance before use and in case the unit is not
used 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.

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

CAUTION
Do not use an autoclave or other high-temperature sterilizing methods.

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

- 10 -

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 maximum)

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 battery
indicators.

External output :

Headset (3.5 mm jack)

Operating environment:

10 to 40 degrees Centigrade
85% humidity or less with no condensation

Storage and transport


environment:

0 to 50 degrees Centigrade
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-60601-1
Equipment with an INTERNAL ELECTRICAL
POWER SOURCE
Type BF device applied part

ACCESSORIES :

Ultrasonic gel . . . . . . . . . . . .
AA alkaline batteries . . . . . . .
Carrying bag . . . . . . . . . . . . .

OPTION :

Headset

* Specifications subject to change.

- 11 -

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Hayashi Denki Co., Ltd.


7-11 Arima 2-chome, Miyamae-ku, Kawasaki, 216-0003 Japan

101EX2 OM E-12
Printed in Japan
October 3, 2003
080-00062