1

PREFACE
PREFACE

System HD.ESWL-V

Documentation Operating Manual

Revision Ver2.7

Date 07/08

Language English
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Operating manual

PREFACE
©2002 Shenzhen Houyuan Medical Instrument Co.,Ltd.
All rights reserved.

No part of this operating manual may be reproduced

or transmitted in any form without written permission
from Shenzhen Houyuan Medical Instrument Co.,Ltd.

Manufacturer Shenzhen Houyuan Medical Instrument Co.,Ltd.

5/F, Blg13, Zhongxing Industrial Zone, Nanshan
District, Shenzhen, China
Telephone: 0086-755-26099369
Telefax: 0086-755-26094935
E-mail: sapphire1048@163.com
http://www.houyuan.com
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List of revisions

PREFACE
Date Revision Content
08/2006 Original
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Declaration of conformity

PREFACE
Manufacturer Shenzhen Houyuan Medical Instrument Co.,Ltd.
Address Shenzhen Houyuan Medical Instrument Co.,Ltd.
5/F, Blg13, Zhongxing Industrial Zone, Nanshan
District, Shenzhen, China
Product Extracorporeal shock wave lithotripter
Model Code HD.ESWL-V

Classification
II b (according to MDD, Article 9)

General applicable directives

Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC of
14 June 1993 concerning medical devices (MDD 93/42/EEC).

Standard
Harmonized Standards (Published in the Official Journal of the
European Communities) applicable to this produce are ISO9001,
ISO13485, EN1441, EN60601-1, EN60601-1-2, EN980 and IEC878.

Notified Body
Institute for Medical and Hospital Engineering (ORKI)

No. of Notified Body

CE1011

Place and Date

Shenzhen, China/August 7, 2006

Signature: ____________
Name:
Position:
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EC representative information

PREFACE
European Representative PRO-BAOFENG KFT.
Address 148 Bp., Nagy Lajos kir. Ut49.
Telephone No. 0036 1 2230520
Fax 0036 1 2230520
E-mail cap4you2000@yahoo.com.cn

Reading illustration
Caution Do always follow the instructions to prevent injury to human body
or damage to the lithotripter. Violation to the Caution may lead to
slight injury to the human body.
Warning Do always follow the instructions to prevent injury to human body
or damage to the lithotripter. Violation to the Warning may lead to
serious injury to the human body.
Authorized personnel The staff trained by Shenzhen Houyuan Medical Equipment Co.,Ltd.
or by the company authorized by Houyuan.
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TABLE OF CONTENTS
TABLE OF CONTENTS
Preface .................................................................................................................................................................. 1
Operating manual .................................................................................................................................... 2
List of revisions......................................................................................................................................... 3
Declaration of conformity....................................................................................................................... 4
EC representative information ............................................................................................................... 5
Reading illustration ................................................................................................................................. 5
Table of Contents .................................................................................................................................... 6
Foreword ....................................................................................................................................................... 8
Introduction ............................................................................................................................................... 8
HD.ESWL-V .............................................................................................................................................. 9
Medical use .............................................................................................................................................. 10
Contraindications of the application of shock waves ..................................................................... 11
Technical information ........................................................................................................................... 12
Safety ............................................................................................................................................................ 13
Introduction ............................................................................................................................................. 13
Responsibility of manufacturer ........................................................................................................... 14
User responsibility ................................................................................................................................. 15
Safety for patient .................................................................................................................................... 16
Use of electromagnetic shock waves................................................................................................... 17
Precaution before shock wave releasing ............................................................................................ 18
Safety for operating staff ...................................................................................................................... 18
Safety for the HD.ESWL-V ................................................................................................................... 19
Device labels ........................................................................................................................................... 20
Description ................................................................................................................................................. 21
Introduction ............................................................................................................................................. 21
Parts and View of the HD.ESWL-V .................................................................................................... 22
Main unit ................................................................................................................................................. 23
Table assembly ....................................................................................................................................... 23
Operating table ....................................................................................................................................... 24
Electrical assembly ................................................................................................................................. 24
Coupling cushion ................................................................................................................................... 25
Therapy head arm................................................................................................................................... 25
Image intensifier .................................................................................................................................... 25
X-ray Tube ............................................................................................................................................... 25
Remote operating panel ........................................................................................................................ 26
Operating panel ...................................................................................................................................... 26
Operation .................................................................................................................................................... 30
Introduction ............................................................................................................................................. 30
Observe safety instructions and regulations..................................................................................... 31
Routine check .......................................................................................................................................... 32
Remove air from the water ................................................................................................................... 33
Prepare ESWL.......................................................................................................................................... 34
Localization ............................................................................................................................................. 35
Perform ESWL......................................................................................................................................... 37
Conclude ESWL ...................................................................................................................................... 39
Specifications ........................................................................................................................................... 40
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Introduction ............................................................................................................................................. 40

TABLE OF CONTENTS
Dimensions.............................................................................................................................................. 41
Voltage/Frequency ................................................................................................................................. 41
Power supply........................................................................................................................................... 41
Environment ............................................................................................................................................ 41
Shock wave .............................................................................................................................................. 42
Fluoroscopy ............................................................................................................................................. 42
Radiography ............................................................................................................................................ 42
Table movements ................................................................................................................................... 42
Maintenance .............................................................................................................................................. 43
Introduction ............................................................................................................................................. 43
Safety check ............................................................................................................................................. 44
Servicing the HD.ESWL-V ................................................................................................................... 45
Replacing consumable parts ................................................................................................................ 45
Maintenance ............................................................................................................................................ 46
Fuse replacement .................................................................................................................................... 48
Clean and disinfect the HD.ESWL-V ................................................................................................. 51
Disposal.................................................................................................................................................... 51
References ................................................................................................................................................. 52
Introduction ............................................................................................................................................. 52
Abbreviations............................................................................................................................................ 1
Glossary...................................................................................................................................................... 1
Transport sign ........................................................................................................................................... 1
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FOREWARD
FOREWORD

The preface informs you about

◼ HD.ESWL-V
Introduction ◼ Main functions
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HD.ESWL-V

FOREWARD
HD.ESWL-V is a shock wave device specially designed for
extracorporeal shock wave lithotripsy (ESWL).

Figure 1 HD.ESWL-V
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Medical use

FOREWARD
HD.ESWL-V is a shock wave device, which allows the following
medical applications.

◼ Extracorporeal shock wave lithotripsy (ESWL).

Ultimately it is the attending physician’s responsibility to decide

whether a patient is suitable for an extracorporeal shock wave
lithotripsy treatment.

Figure 1. HD.ESWL-V Extracorporeal Shockwave

Lithotripter
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Contraindications of the application of shock waves

FOREWARD
Before applying a shock wave treatment, the attending physician must
examine the relevant contraindications and make an appropriate
treatment decision relative to the risks presented by alternative
treatment methods.

Contraindications include:
◼ Relevant coagulopathy
◼ Pulmonary tissue in shock wave path
◼ Intestinal gas in shock wave path
◼ Tumor in shock wave area
◼ Aneurysms in shock wave path
◼ (Unclear) pathological changes

Relative contraindications are:

◼ Pregnancy
◼ Shock wave exposure in case of infection in the treatment area
◼ Epiphyseal cartilage in focal area
◼ Areas close to the spinal column

Additional contraindications for the application of shock wave are:

◼ Polyneuropathies
◼ Polyarthritis

It is the responsibility of the attending physician to adapt applications

and treatment procedures to state-of-the-art medicine. Before treating a
patient with a pacemaker, he or she must carefully examine whether
the ESWL can be performed without risk on the basis of the known and
documented criteria.

WARNING Shock wave may cause serious damage while passing organs that
contain gas.

Do not deliver shock wave to organs that contain gas.

CAUTION Shock wave may cause unwanted cardiac activity. Shock wave release
shall be stopped in case the patient presents such activity.
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Technical information

FOREWARD
HD.ESWL-V generates shock waves by means of a flat coil and a
membrane. The flat coil and membrane, as well as the technology of
shock wave generation, are called EMSE, which stands for
electromagnetic shock wave generator.

The flat coil receives high voltage in impulses. The membrane, which is
in direct contact with the flat coil, is pushed out by the high voltage
impulse. A shock wave is then produced and eventually is focused by
an acoustic lens.
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SAFETY
SAFETY

Introduction
The safety section describes the safety aspects that must be observed
when operating the HD.ESWL-V.
◼ Responsibility of the manufacturer
◼ Responsibility of the user
◼ Electrical installation of the HD.ESWL-V
◼ Safety of patient
◼ Use of electromagnetic shock wave
◼ Precautions during shock wave release
◼ Dangerous area
◼ Safety of operating staff
◼ Safety of the HD. ESWL-V
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Responsibility of manufacturer

SAFETY
Regardless of the specific requirements set by relevant liability
standards, Shenzhen Houyuan Medical Instrument Co.,Ltd assumes
responsibility under the following conditions only:

Assembly, adjustment, maintenance and modifications are performed

only by Shenzhen Houyuan Medical Instrument Co.,Ltd personnel or
persons authorized by Shenzhen Houyuan Medical Instrument Co.,Ltd

Electrical installation of treatment room complies with applicable

national standards.

Operation of HD.ESWL-V is in accordance with valid operating manual

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User responsibility

SAFETY
Operate the HD.ESWL-V only in an appropriate area where the
electrical installation complies with applicable national installation
standards.

The HD.ESWL-V needs protective earth and functional earth connecting

installation.

WARNING The installation of the HD.ESWL-V shall be conducted only by

authorized personnel.

Both the protective earth terminal and the functional earth terminal
shall be connected properly before being activated.

Earth connection shall be checked at least every six months for

defects.

The installation room shall comply with applicable local regulations

of X ray radiation prevention.

To protect the environment, the X ray shall be used only in a closed

space with adequate X ray preventing construction.

WARNING After installation or reinstallation, the HD.ESWL-V shall be tested in

terms of electrical safety.
Refer to maintenance chapter of this manual for more detailed
instructions.
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Safety for patient

SAFETY
◼ Operation of the HD.ESWL-V

Do not operate the HD.ESWL-V in an explosive and/or inflammable

atmosphere. An explosive and/or inflammable atmosphere is caused,
for example, by vapors emanating from anesthetic, cleaning agents or
disinfectants.

◼ Informed Consent of Patient

The patient must be informed about the treatment process. In

particular, the patient must be informed about the noise caused by the
release of shock waves. This prevents the patient being startled and
making involuntary movements during treatment.
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Use of electromagnetic shock waves

SAFETY
Physicians who use shock waves in therapy must be familiar with the
medical aspects of the process, including currently valid indications
and contraindications as well as corresponding adverse effects.
Especially, but not exclusively, patients with coagulopathy must be
excluded from treatment.

If shock waves are directed into air-filled organs, such as the intestinal
tract or the lungs, tissue damage can ensue. Particular caution is
recommended in order to avoid directing shock waves into lungs.

There is a direct relationship between the shock wave dose (shock wave
intensity × number of shock waves) and the appearance of hematomas.
It should not be ruled out that the height of the shock wave release
frequency could influence the occurrence of side effects. Although this
has not yet been definitely proven by scientific means, medication, age,
blood pressure or vascular deficiencies, especially in the renal area, can
increase the risk of side effects during exposure to shock waves. The
sensitive vessels in the renal parenchyma are particularly at risk, since
lesions caused by excessive shock wave intensity can result in
hematomas. For this reason, the shock wave dose must always be
maintained as low as possible. As the shock wave intensity increases,
the release frequency must be decreased.

Before releasing shock waves, ensure good contact between the

patient’s body and coupling cushion in the shock wave impact area. Air
bubbles between the patient’s body and the coupling cushion diminish
the effect of shock waves and can lead to unsatisfactory treatment
results.

CAUTION The shock wave generated by the lithotripter is attenuated during

passage through tissue, and its additional energy is absorbed by bone.
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Precaution before shock wave releasing

SAFETY
An acoustic shock is heard during shock wave releasing. It is
recommended that the operating staff and patient wear earplug during
shock wave treatment.

Safety for operating staff

◼ Training operating staff on the HD.ESWL-V

Shenzhen Houyuan Medical Instrument Co.,Ltd offers comprehensive

training on the HD.ESWL-V for physicians and operating staff alike.

Under no circumstance should untrained or unqualified personnel

operate the HD.ESWL-V. Training is provided by authorized staff of
Shenzhen Houyuan Medical Instrument Co.,Ltd.

◼ Duty of operating staff

Both operating staff and cleaning staff should apply utmost care when
handling the HD.ESWL-V.

Before activating the HD.ESWL-V, the operator should have completely

read and understood the operating manuals.

◼ Cleaning and disinfecting of the HD.ESWL-V

Disconnect power supply before cleaning and disinfecting the

HD.ESWL-V.
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Safety for the HD.ESWL-V

SAFETY
Electromagnetic compatibility

HD.ESWL-V complies with electromagnetic compatibility requirements

according to IEC601-1-2 and IEC60601-2-36. According to the standards,
however, the EMC of the HD.ESWL-V during the triggering and
generation cycle of the shock wave release may not comply with
IEC60601-1-2.

CAUTION Shock wave release may cause interference with other devices. Keep
the HD.ESWL-V away from electronic monitors while shock wave is
being released.

Shock waves should be triggered in coupled state only.

Reflection and refraction at contact surface between coupling cushion
and air may damage coupling cushion.
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Device labels

SAFETY
Table 2 shows the labels on the HD.ESWL-V.

Table 2 Warnings and information labels

Labels Meaning

Observe operating manual.

Risk of contusion!

Type B Equipment

Nameplate
Device’s and manufacturer’s reference inclusive of:
Name of the manufacturer: Shenzhen Houyuan
Medical Instrument Co.,Ltd
Name of the system: Extracorporeal shock wave
lithotripter
Model of the system: HD.ESWL-V
SDA register No. of the system
Production date of the system
Input power of the system
Address of the manufacturer
CE mark and its notify body No.
Functional earth terminal
Need to be connected while installation.

Protective earth terminal

Need to be connected while installation.
Power button indicating marks: push the button
down to the lower position to power the system
and push a second time to release the button to a
higher position to turn off the system.
(Appears on the nameplate) Refers to alternating
～(380V) current electricity power.
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DESCRIPTION
DESCRIPTION

Introduction
The description section contains the overview and description of
functional parts and controls of the HD.ESWL-V.
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Parts and View of the HD.ESWL-V

DESCRIPTION
Figure 3 shows the HD.ESWL-V and its functional parts.

Figure 3 HD.ESWL-V
8 7

5
1

1. Main unit 6. Therapy head arm

2. Table assembly 7. C arm
3. Operating table 8. Image intensifier
4. Electrical assembly 9. X-ray tube
5. Coupling cushion
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Main unit

DESCRIPTION
The main unit is the
mechanical and electrical
assembly of the X ray and the
shock wave generator.

The main unit may be turned

away from its original
position to give more space
for the independent use of the
table.

Table assembly
The table assembly
gives mechanical
and electrical
support to the table.
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Operating table

DESCRIPTION
The operating table offers the operator a
convenient control of HD.ESWL-V

Electrical assembly
The electrical assembly contains most of the HD.ESWL-V’s electrical
circuits and components.
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DESCRIPTION
Coupling cushion
The coupling cushion, to be fulfilled with water before an ESWL
treatment, transmits the shock wave generated by the therapy head to
the human body with little attenuation.

Generally a coupling cushion lasts for dozens of treatments. However,

it shall be replaced by a new one in case of breakage or rupture.

Therapy head arm

The therapy head arm gives mechanical support to the therapy head.
The therapy head therefore can move along its orbit.

The therapy head arm may be turned away from its original position to
give more space for independent use of X ray and the table.

Image intensifier
The image intensifier (I.I) transfers X rays, which are originally
invisible, into visible images.

The I.I, which plays a very important role in the X ray system, is a
device so sophisticated that it shall always be kept away from bumping,
damping and shocking.

X-ray Tube
The tube, which emits X ray under high voltage, is a major part of the X-
ray generating system.

The tube contains fragile glass materials and shall be carefully attended
and avoid bump, damp and shock.
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Remote operating panel

DESCRIPTION
The remote operating panel prevents the attending operator from being
exposed to X ray radiation while using X ray functions of the
HD.ESWL-V.

Operating panel
The operating panel offers all function buttons of the HD.ESWL-V.
Figure 10 and 11 show all the buttons and indicators of the operating panel
Figure 10

Figure11 The display panel of the operating table

Figure 12
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DESCRIPTION
Table 6 Buttons and indicators on the remote operating panel

Button/meter Purpose
Power switch
Press the button to a lower position to switch on the lithotripter, and press
again to a higher position to switch off the lithotripter.
High voltage startup
Press down to connect the high voltage of the shock wave

High voltage stop

Press down to disconnect the high voltage of the shock wave

Energy button
Turn the button to increase/decrease the intensity of the shock wave

Shock wave triggering frequency

Turn the button to increase/decrease the frequency of the triggering
Cardiogram triggering

Input the synchronic signal of the cardiogram, and press down the button
to generate shock wave synchronically.

Continuous triggering
Press down the button to generate shock wave automatically

Manual triggering button

Press down the button to generate single pulse of shock wave

Input water
Press down the button all the time to input water to the coupling cushion

Drain water
Press down the button all the time to drain water from the coupling
cushion and input it into the tank in the main unit.

Heating

Vertical movement of the supporting C arm

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Null

DESCRIPTION
C arm clockwise/counterclockwise movement

3-D movement of the table

X-mA adjustment

X-kV adjustment

Exposure

Energy indicator
To indicate the triggering voltage of shock wave

Shock wave triggering counter/reset

To indicate the times of triggering
To press the right button to reset the counter

Shock wave triggering voltage/power voltage/X-ray voltage/X-mA indicator

B-Ultrasound distance display

Water recycling
Press down the button to recycle the water between the tank and the
coupling cushion

Degas button

Probe move forward/backward buttons

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DESCRIPTION
Vertical movement of intensifier

Table top tilting movement

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OPERATION

OPERATION
Introduction
The operation section informs you about:
◼ Which safety instructions must be observed
◼ How to activate the HD.ESWL-V
◼ What to observe before and during startup of the HD.ESWL-V
◼ How to perform treatment with the HD.ESWL-V
◼ How to check localization accuracy
◼ How to deactivate the HD.ESWL-V
◼ How to clean the HD.ESWL-V

Safety instructions described in the safety section must be observed.

Figure 13 shows the operating procedure of the HD.ESWL-V.

Figure 13 Operating procedure

Operation
introduction

Routine check

Prepare ESWL

Localization

Perform ESWL

Conclude ESWL

Deactivation

Cleaning
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Observe safety instructions and regulations

OPERATION
Before operating the HD.ESWL-V, it is necessary to read and to observe
the safety instructions and regulations given in this manual.

Observe safety instructions in the Safety section

Observe relevant national regulations concerning the operation of
shock wave devices
 32

Routine check

OPERATION
Routine check before activating the HD.ESWL-V helps you avoid
danger due to any defect or damage of the device.

Visual check Check the following devices and components for defects and damages:
◼ Coupling cushion
◼ C arm and table
◼ Outer cables and connections
◼ Control panel

WARNING Do not activate the HD.ESWL-V if the protective earth terminal is

not properly connected.
Only authorized personnel could conduct the above-mentioned eye
check. Authorized personnel are exclusively persons who have been
trained by Shenzhen Houyuan Medical Instrument Co.,Ltd. or by a
company authorized by Shenzhen Houyuan Medical Instrument
Co.,Ltd.

WARNING Do not activate the HD.ESWL-V if any defect or damage is found

during the routine check.
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Remove air from the water

OPERATION
If there are air bubbles in the coupling cushion, remove them
following the instructions below:
1) Adjust the therapy head to such a position that the de-gas
pipe of the coupling cushion is on the top;
2) Untie the de-gas pipe of the coupling cushion and hold it in
the way showed in figure 14;
3) Tap on the cushion to de-gas;
4) Tie the de-gas pipe after all the air bubbles are expelled..

Figure 14 Degas the water

WARNING Do not release shock waves if there are air bubbles in the
coupling cushion.
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Prepare ESWL

OPERATION
1. Disinfect the surface of the coupling cushion and the table;
2. Power the system by pressing down either of the power switch
buttons on the operating panels;
3. Press activate button to get started;
4. Press shock wave kV increasing button several times to raise the
voltage to an appropriate value.1;
5. Press single shock wave release button several times to run the
HD.ESWL-V on trial. Make sure that everything is in order.

WARNING The application parts of HD.ESWL-V, cushion and tabletop surface

for example, shall be disinfected before use.

1Anappropriate value means a comfortable treatment to a specific individual. Since the sensitivity extent may vary
when treating different patients, the value will not be a fixed one. Generally, it may be between 8kV to 12kV.
 35

Localization

OPERATION
Accurate localization is a fundamental guarantee for a successful ESWL
operation. HD.ESWL-V generally offers two different means of
localization:
◼ X ray; and
◼ ultrasound (optional).

Ultrasound Before the patient lies on the table, the operator shall use the ultrasound
localization(optional) probe to check the calculus’ position, quantity and shape and, if
necessary, mark its best detecting position on the patient body. Then set
a proper position of the shock wave head, the probe and the cushion
according to the detecting depth of the ultrasound, and then apply
coupling gel to the surface of cushion and the probe. Then follow the
operations below.

1. Press button on the operating panel to set

an appropriate detecting angle for the ultrasound probe. Be careful not
to press the probe too hard to avoid any possible damage.

2. Watch if there is calculus image appearing on the monitor screen. If

no, rotate the sliding ring to which the probe is attached to change the
detecting angle until the calculus is located.

3. Search for fragmentation focus in ultrasonic image:

Watch the probe-focus distance indicator and note the READING,
which indicates the distance between the probe surface and the shock
wave focus.

4. Activate the measuring function of the ultrasound (refer to the

ultrasound scanner’s manual for detailed operations), move the “ + ”
cursor vertically downward from the top of the central line until the
ultrasound scanner displays a figure that equals the READING, note
down the STOP POSITION of the “ + ” cursor.

5. Press table moving buttons (on the operating panel) to move the
calculus image on the ultrasound screen to the STOP POSITION.

Note: during the above process, if it is necessary to extend the penetrate depth
of shock wave focus, withdraw the probe, remove some water out of the cushion
first.

After the above steps, the localization with ultrasound is completed.

 36

X ray localization Before the fragmentation, the operator shall confirm the calculus’

OPERATION
position, quantity and shape by means of radiography.

After the patient is laid on the table, apply a coat of coupling gel on the
cushion.

1) Prepare for the localization

① Push the related button on the operating panel to make the C-arm
in the original vertical position.
② Push the related button on the operating panel to make the therapy
head in the highest position.
③ Turn on the X ray monitor, set a proper pattern, then perform
fluoroscopy several times to confirm the quality of the X ray image .
④ Push table moving buttons to move the patient right under the
image intensifier.

2) Positioning Operation
①First, locate the calculus. Perform fluoroscopy frequently as well as
adjust the position of the C arm and the table by pushing related
buttons. Watch the monitor screen carefully, when the calculus image
appears, position the calculus image to overlap the shock wave focus
mark on the monitor screen by pushing table motion buttons.
②Push related button to set the C-arm in its left position, then perform
fluoroscopy and watch the monitor screen carefully and make sure the
calculus image overlaps the shock wave focus, and then move to the
next step. If the calculus image deviates from the shock wave focus
mark, push table motion buttons to position the calculus to overlap the
focus mark.
③Push the related button to fill the cushion and make sure there is a
direct contact between the cushion and the patient’s skin. Pay attention
not to overfill the cushion in order to prevent lifting the patient and
causing displacement of the calculus. Perform fluoroscopy to make sure
the calculus image overlaps the focus mark on the monitor screen.

The X-ray localization is completed after the above steps are done.
 37

Perform ESWL

OPERATION
After the localization is completed, start releasing shock waves to
perform ESWL by pressing the related button.

WARNING Before performing ESWL, the intended physician shall inform the
patient about the treatment process. In particular, the patient must be
informed about the noise caused by the released of shock waves. This
prevents the patient being startled and making involuntary
movement during treatment.

Noise of releasing shock waves could be harmful. It is recommended

that the operator and the patient wear earplugs to reduce the noise.

Set frequency

Press either of the frequency adjusting buttons to increase or reduce the

shock wave releasing frequency. Generally, a low frequency (≤0.5Hz)
is desired at the beginning of the treatment, and the attending physician
may increase the frequency little by little during the treatment if the
patient adapts to the shock wave well.

Set shock wave intensity

Press the related buttons to increase or reduce the shock wave intensity.
Generally, a low intensity (≤12kV) is desired at the beginning of the
treatment, and the attending physician may increase the intensity little
by little during the treatment if the patient adapts to the shock wave
well.

WARNING The attending physician must always monitor the patient throughout
the treatment. If patient feels uncomfortable or presents a risk, the
treatment must be terminated immediately.

WARNING The water temperature may rise during the process of ESWL
 38

treatment. The attending physician should always monitor the WT

OPERATION
indicating light on the operating panel. The treatment shall be
stopped and the patient shall be separated from the HD.ESWL-V if
the light is on.
In this case, the attending physician should perform the water cycling
function of the HD.ESWL-V by pushing the water cycling button on
the operating panel. The treatment can be resumed only when the
temperature of the cushion is lowered and the indicating light is off.

WARNING Do not set a high shock wave intensity exceeding 15kV each time
before treatment.

Within one treatment a patient shall not be given more than 3000
shock waves. Interval between two treatments on one patient shall be
no less than 7 days.

WARNING Through out the ESWL treatment, the attending physician shall check
the position of the calculi by X ray or ultrasound as often as necessary
to ensure the calculi are at the shock wave focus.

WARNING Even if anti-collision devices are installed, the attending operator

shall always watch for any movements that may cause danger to the
patient or operator.
 39

Conclude ESWL

OPERATION
Once the calculus image on the monitor screen becomes larger and
lighter, sometimes just disperses or disappears, it may be inferred that
the calculus is fragmented. In this case the ESWL shall be concluded
and the patient shall be asked to take radiography to confirm the
fragmentation.

Nevertheless, to avoid patient injury, the ESWL shall be ended even if

the calculus image does not show the above phenomena after 3000
times of shock wave release.

Steps to stop 1. Push stop button on the operating panel to stop shock wave release;
2. Ask the patient to get off the HD.ESWL-V;
3. Push decrease button repeatedly to drop the kV value to 0;
4. Press manual triggering button once or twice to release the
remaining voltage;
5. Press stop button to deactivate the HD.ESWL-V;
6. Press power button to turn off the HD.ESWL-V;
7. Clean the patient’s skin;
8. Clean the coupling cushion of the HD.ESWL-V;
9. Clean the surface of the table and other parts as many as necessary.

WARNING Risk of electrical shock!

Do not skip step 4 when deactivating ESWT.
 40

SPECIFICATIONS
SPECIFICATIONS

Introduction The specifications section provides technical information on

◼ Dimensions
◼ Voltage/frequency
◼ Power supply
◼ Environment
◼ Shock wave parameters

All the specifications are standard values unless the tolerance is

specified.
 41

Dimensions

SPECIFICATIONS
◼ Weight 1600kg
◼ Cubage 24m3

Voltage/Frequency
Input Voltage ~380V
Frequency 50Hz

Power supply
Input Power supply 5kVA

WARNING Do not power the HD.ESWL-V by supply main, which is not in

accordance with the above-mentioned specifications.

WARNING It’s recommended that the user provide voltage stabilizer to prevent
HD.ESWL-V from being damaged by fluctuating supply main
voltage.

Environment Room temperature

◼ During therapy 10℃～32℃
◼ In storage (without water) -10℃～40℃
◼ In storage (with water) 1℃～70℃

Water used in coupling cushion

◼ Water hardness ≤1,0 °dH

Relative humidity
◼ During therapy 30～75% (no coagulation)
◼ In storage 10～75% (no coagulation)

Atmospheric pressure
◼ During therapy 70～106 Kpa
◼ In storage 50～106 Kpa
 42

Shock wave ◼ Principle Electromagnetic

SPECIFICATIONS
◼ Penetration depth 130mm
◼ Focus pressure P+ 20～72MPa
◼ Focal range 7mm×7mm×25mm
◼ Triggering voltage 15～20kV
◼ Triggering frequency 60～180 Shock waves/min

Fluoroscopy ◼ Tube voltage 50～100kV

◼ Tubes current 0.1～5mA;
◼ Resolution of X-ray image 14LP/mm;
◼ Diameter of image intensifier 9 inches

Radiography ◼ Radiography current 1~200mAs constantly adjustable

◼ FFD 800-1150mm
◼ Film size 17″× 17″

Table movements ◼ Vertical 0～250mm

◼ Longitudinal 0～200mm
◼ Latitudinal 0～120mm
◼ Tilting clockwise 20°
◼ Tilting counterclockwise 10°
◼ Maximum table load capacity 135kg
 43

MAINTENANCE
MAINTENANCE

Introduction The maintenance section informs you about:

◼ Safety checks
◼ Servicing the HD.ESWL-V
◼ Replacing consumable parts
◼ Maintenance
◼ Fuse replacement
◼ Cleaning and disinfecting the HD.ESWL-V
◼ Disposal of the HD.ESWL-V
 44

Safety check

REFERENCES
Periodic safety check Safety checks mean maintenance and adjustment at regular intervals.
Safety checks guarantee the safe and reliable operation of the
HD.ESWL-V.
Shenzhen Houyuan Medical Instrument Co.,Ltd. recommends safety
check once 12 months.

Occasional safety test The HD.ESWL-V shall be tested when any of the following happens:
◼ Installation
◼ Reinstallation
◼ Modification
◼ Electrical consumable parts replacement

The periodic safety check list and the occasional safety test list will be
provided by Shenzhen Houyuan Medical Instrument Co.,Ltd. free of
charge on request.

WARNING Only authorized persons may perform maintenance, safety check,

service and replacement of consumables on the HD.ESWL-V.
Authorized persons are exclusively persons who have been trained
by Shenzhen Houyuan Medical Instrument Co.,Ltd or by a company
authorized by Shenzhen Houyuan Medical Instrument Co.,Ltd.
Maintenance, safety check, service and replacement of consumables
conducted by unauthorized persons can result in critical injury to
persons and/or serious damage to the HD.ESWL-V.
 45

REFERENCES
Servicing the HD.ESWL-V
Whenever the HD.ESWL-V presents any malfunction or defects, it
shall be stopped for service.

Replacing consumable parts

Occasional safety test The 4 consumable parts for HD.ESWL-V as follows:
A. HV unit
B. Shock wave pan
C. Lens
D. Coupling cushion

Only authorized persons may replace item A, B and C.

Replace a coupling cushion

Procedures:
1) Discharge the water inside the cushion;
2) Loose the nuts on the metal loop that binds the cushion with a screw
driver;
3) Remove the metal loop and cushion;
4) Replace with a brand new cushion and fix the metal loop and tighten
the nuts with the screwdriver.
 46

Maintenance

REFERENCES
Maintenance shall be performed as often as necessary to guarantee the safe
and reliable operation of the HD.ESWL-V.

Shenzhen Houyuan Medical Instrument Co.,Ltd. provides recommended

procedures for maintenance.

Recommended procedures for maintenance

1. General
1.1 Get information on the state of the system from the hospital personnel
1.2 Check the system for mechanical damage, corrosion and cleanliness
1.3 Check calibration tools and accessories

2. Electrical
2.1 Check cables, cable protection hoses and connectors
2.2 Check all terminals and ground connectors

3. Water Circuit
3.1 Clean water circulation
3.2 Check coupling bellows
3.3 Check water hardness before filling water
3.4 Fill system with water
3.5 Check residual oxygen content
3.6 Check all hoses and connections for sealing
3.7 Check air-filter of cooling system
3.8 Check function of water circulation
3.9 Check function of coupling pressure control

4. Positioning
4.1 Check movement and end positions of all axes
4.2 Check moving speed of all axes
4.3 Check focal point adjustment with x-ray system
4.4 Check function of movement stop switch.
4.5 Check therapy head anti-collision device
4.6 Lubricate drive spindles and guide rails

5. Urology operating attachments

5.1 Eye check of attachments
5.2 Check locking of leg rest, should support and belly band

6. Control Panel
6.1 Check keyboard functions
 47

7. Shockwave Circuit

REFERENCES
7.1 Check high voltage connections for signs of arcing
7.2 No uncontrolled shock wave releases up to maximum intensity
7.3 Check function of shock wave counter
7.4 Check the safety functions of the shock wave circuit
7.5 Read and record SYSTEM shock wave count

8. C Arm
8.1 Check the function of the C arm
8.2 Check the crosshairs fade in and movement
8.3 Check the C arm with focus calibration tools
8.4 Check the C arm for accuracy of the focus mark on the monitor screen
8.5 Check the function of the anti-collision device
8.6 Video printout of adjustment

9. Ultrasound System
(If applicable, follow the original manufacturer’s recommendation)
9.1 Check the electrical connections of the ultrasound system
9.2 Verify correct power up sequence
9.3 Read and record the software version of the ultrasound system
9.4 Check and set time and date
9.5 Check image processing functions of ultrasound unit
9.6 Check probe-focus distance indicator for accuracy
9.7 Run diagnostic tests of ultrasound system
9.8 Check image quality during shock wave release and movement

10. Final System Check

10.1 Perform simulated calculi fragmentation test

11. Check focal point with focus calibration tools

11.1 Perform overall system test
11.2 Perform safety checks according to valid Safety Check List

12. X ray unit

12.1 Check the defaults on the control panel after system boot up
12.2 Check noise reduction functions
12.3 Check the last image hold function
12.4 Check pulse fluoroscopy
12.5 Check manual fluoroscopy
12.6 Check radiation indicators
12.7 Check timer reset button on the control panel
12.8 Measure real kV with voltmeter
12.9 Measure real current (mA)
12.10 Check the image size with ETR-1 on the monitor
12.11 Check resolution with a line phantom and 25mm AL-filter
12.12 Check the image intensifier entrance dose rate with 25mm AL-filter
and 1.5mm Cu-filter and check the high voltage on the control panel
12.13 Test the monitor functions
 48

Fuse replacement

REFERENCES
Fuses of the main unit

1 2 3 4 5

No Fuse No Specification
1 17FU T3A/500V
2 18FU T3A/500V
3 19FU T2A/500V
4 16FU T5A/500V
5 2FU T8A/500V
 49

Fuses in the main unit

REFERENCES
1 2 3 4 5 6 7 8

No Fuse No Specification
1 17FU T3A/500V
2 18FU T3A/500V
3 19FU T2A/500V
4 16FU T5A/500V
5 2FU T8A/500V
6 19FU T2A/500V
7 16FU T5A/500V
8 2FU T8A/500V
 50

Fuse in the operating panel

REFERENCES
1 2 3 4 5 6 7 8 9 10 11 12 13

No Fuse No Specification
1 17FU T3A/500V
2 18FU T3A/500V
3 19FU T2A/500V
4 16FU T5A/500V
5 2FU T8A/500V
6 19FU T2A/500V
7 16FU T5A/500V
8 2FU T8A/500V
9 2FU T8A/500V
10 19FU T2A/500V
11 16FU T5A/500V
12 2FU T8A/500V
13 2FU T8A/500V
 51

Clean and disinfect the HD.ESWL-V

REFERENCES
1. Disconnect the power supply of the HD.ESWL-V.
2. Clean and disinfect the HD.ESWL-V as follows:
◼ Cleaning: Wipe off dirt and blotches on the accessible surface
of the HD.ESWL-V with a sponge or soft cloth.
◼ Disinfect: After cleaning, wipe the accessible surface of the
HD.ESWL-V with a sponge or a piece of soft cloth which is
intentionally wet but not dripping with any of such
disinfectants as medical alcohol, Formalin and etc. The
applying parts of the HD.ESWL-V, namely the surface of the
following parts and the operating panels shall be disinfected
before every ESWL operation:
1) Coupling cushion;
2) Operating panels;
3) Any other parts which may contact with patients or
operators during the operation.

WARNING Disconnect the power supply before cleaning and disinfecting the
HD.ESWL-V.
Do not use gas and/or spray disinfectants to disinfect the
HD.ESWL-V.
Do not let liquid penetrate into the HD.ESWL-V, especially into
electrical parts.
Observe instructions given by manufacturer of disinfectants as well
as legal regulations concerning disinfection and cleaning against
explosion.

Disposal
At the end of its service life, the HD.ESWL-V must be disposed of in
accordance with the applicable local regulations.

The different materials (e.g. packing, electronic scrap, plastics, metal,

water, etc) must be disposed of in accordance with the applicable
national regulations.

For inquiries regarding the avoidance of personal injury and/or

contamination to the environment, please contact Shenzhen Houyuan
Medical Instrument Co.,Ltd. before the HD.ESWL-V is out of its term in
use.
 52

REFERENCES

REFERENCES
Introduction
The references section contains:
◼ List of abbreviations
◼ Glossary
 52

Abbreviations

REFERENCES
Abbreviations Meaning

ESWL Extracorporeal Shock Wave Lithotripter

Glossary
Glossary Meaning

Shock wave pan The pan-shaped shock wave generator

Coupling gel Medium used to eliminate air between

patient’s skin and coupling cushion. Air
impairs effect of shock waves.

Transport sign

Fragile Up Damp proof

Storage condition
Temperature : -40～55℃
Relative humidity : 10～95%
Atmospheric pressure:50～106 kPa

Dimension：
Gross weight：
Net weight：
Name: Shenzhen Houyuan Medical Instrument Co.,Ltd.
Address: 5/F, Blg13, Zhongxing Industrial Zone,
Nanshan District, Shenzhen, China
Telephone: 0086-755-26099369
Telefax: 0086-755-26094935
E-mail: sapphire1048@163.com
http://www.houyuan.com