E300UserManualVerA 1

2797
E300 EXTRACORPOREAL SHOCK WAVE

THERAPY SYSTEM
User Manual Version A.1
For Any Service Support Please Contact
VOLLWERT MEDICAL EQUIPMENT TRADING LLC.
PO Box : 64162, M7, Block A, Al Khallafi Building,

Al Wuheida Road,Al Mamzar,
Dubai, United Arab Emirates.
Tel : +971 4 2388990 Mob : +971 551806636
Email :mail@vollwert.eu
www.eswl.com | www.wikkon.com |
www.eswl.cn Tel: +86-755 25931925 | Email:
export@eswl.cn
©1996-2017 Shenzhen Huikang Medical Apparatus Co., Ltd.
All rights reserved.
Table of Contents
Preface .............................................................................................................................................................................. 3
Classification ..................................................................................................................................................................... 6
Reading Illustration ........................................................................................................................................................ 11
Packing List...................................................................................................................................................................... 11
1. Foreword ................................................................................................................................................................. 12
E300 ......................................................................................................................................................................... 12
Medical Applications............................................................................................................................................... 13
Technical Information ............................................................................................................................................. 13
Shock Wave Medical Application Principle ............................................................................................................ 13
2. Safety ....................................................................................................................................................................... 15
Responsibility of Manufacturer .............................................................................................................................. 15
Users’ Responsibility ............................................................................................................................................... 15
Safety for Patient .................................................................................................................................................... 15
Labels ....................................................................................................................................................................... 20
Main Unit................................................................................................................................................................. 24
LCD Screen ............................................................................................................................................................... 26
Connectors for Power Supply and Water System .................................................................................................. 28
Therapy Head .......................................................................................................................................................... 30
Articulated Arm and Main Unit .............................................................................................................................. 31
4. Operating Instructions ............................................................................................................................................ 33
Routine check .......................................................................................................................................................... 34
Routine safety inspection ....................................................................................................................................... 34
The use of coupling agent ....................................................................................................................................... 34
Positioning ............................................................................................................................................................... 36
Start treatment ....................................................................................................................................................... 37
End Treatment......................................................................................................................................................... 38
5. Technical Specifications .......................................................................................................................................... 39
Dimensions .............................................................................................................................................................. 39
Power capacitor ...................................................................................................................................................... 39
Environment ............................................................................................................................................................ 40
Shock wave parameters .......................................................................................................................................... 40
Occasional safety check .......................................................................................................................................... 41
Daily maintenance .................................................................................................................................................. 41
Cleaning and disinfection ....................................................................................................................................... 41
Waste disposal ........................................................................................................................................................ 42
Replacement of consumables................................................................................................................................. 42
Maintenance ........................................................................................................................................................... 43
Stability test ............................................................................................................................................................ 44
Procedures for detecting deviations of physical variables that increase the risk of patients ............................. 44
7. Reference: ............................................................................................................................................................... 45
Abbreviations .......................................................................................................................................................... 45
Transport Sign ......................................................................................................................................................... 46
User manual – E300 2

Preface
Product Name Extracorporeal shock wave therapy system
System E300
Documentation User Manual
Revision A.1
Date 2/2020
Language English
Shenzhen Huikang Medical Apparatus Co., Ltd.
Registration address: 5F and Room 101, 1F, Zone 2, Building A,
Haikexing Industrial Park, No.16 Baoshan Road, Jinlong Avenue, Liulian
Community, Pingshan New District, Shenzhen, China
Manufacturing site: 5F and Room 101, 1F, Zone 2, Building A,

Haikexing Industrial Park, No.16 Baoshan Road, Jinlong Avenue,
Liulian Community, Pingshan New District, Shenzhen, China
Tel: +86-755-25515460
Fax: +86-755-25515362
Email: export@eswl.cn
Web: www.eswl.cn, www.eswl.com, www.wikkon.com
©2018 Shenzhen Huikang Medical Apparatus Co., Ltd.
All rights reserved.
No part of this operating manual may be reproduced or transmitted

in any form without written permission from Shenzhen Huikang
Medical Apparatus Co., Ltd.

List of Revisions
Date Revision Modification
01/2020 A.0 Original version
02/2020 A.1 Content revision

Declaration of Conformity
: Shenzhen Huikang Medical Apparatus Co., Ltd.
Location: 5F and Room 101, 1F, Zone 2, Building A, Haikexing Industrial Park, No.16 Baoshan Road, Jinlong
Avenue, Liulian Community, Pingshan New District, Shenzhen, China
Authorized representative in the European Community:

AGADA S.R.L, Via G. Mazzuoli 15 Strada in Chianti, 50027 Firenze, Italy
I hereby declare that the following products manufactured by us

1. Extracorporeal Shock Wave Lithotripters
2. Extracorporeal Shock Wave Therapy Systems
3. High Intensity Focused Ultrasound Tumor Therapy Systems
is hereinafter confirmed to comply with the requirements set out in the Council Directive on the harmonization
of the Laws of the Member States concerning Medical Device Directive (93/42/EEC As amended by 2007/47/EC)
EN ISO 13485: 2012;EN ISO 14971: 2012;EN 1041:2008; EN ISO 15223-1:2012;EN 980:2008; EN
62304:2006/AC:2008;EN 62366:2008;EN 60601-1-6:2010; EN 60601-1: 2006 + A1:2013;EN
60601-1-2:2007; EN ISO 10993-1:2009/COR:2010;EN ISO 10993-5:2009; EN ISO 10993-10:2013; EN
60601-2-36:2015; EN 60601-2-54:2009+A1:2015; EN 60601-1-3:2008+A1:2013; EN 60601-2-28:2010
Conformity Assessment Route:

Annex II excl. section 4 of Medical Device Directive
Notified Body:
BSI Group (NB No.2797)
BSI Group The Netherlands B.V.
Say Building
John M.Keynesplein 9
1066 EP Amsterdam
Netherlands
Shenzhen, Feb 2018.
Executive Director

Classification
Products Model E300
Type Class II b

EMC
1) This product needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided, and this unit can be affected by portable and
mobile RF communications equipment.
2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result
in incorrect operation of the unit.
3) This unit has been thoroughly tested and inspected to assure proper performance and operation!
4) This machine should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, this machine should be observed to verify normal operation in the configuration in
which it will be used.
Guidance and manufacture’s declaration – electromagnetic emission

The E300 is intended for use in the electromagnetic environment specified below. The user of the E300 should assure that it
is used in such an environment.
Emission test Compliance Electromagnetic environment – guidance
The E300 use RF energy only for its internal function.
RF emissions Therefore, its RF emissions are very low and are not
Group 1
CISPR 11 likely to cause any interference in nearby electronic
equipment.
RF emission The E300 is suitable for use in all establishments, other
Class A than domestic and those directly connected to the
CISPR 11
public low-voltage power supply network that supplies
Harmonic emissions buildings used for domestic purposes.
Class A
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
Complies
IEC 61000-3-3

Guidance and manufacture’s declaration – electromagnetic immunity
The E300 is intended for use in the electromagnetic environment specified below. The customer or the user of E300 should
assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level
guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete
(ESD) or ceramic tile. If floor are covered
±8 kV air ±8 kV air
with synthetic material, the
IEC 61000-4-2
relative humidity should be at
least 30%.
Electrical fast ±2 kV for power supply ±2kV for power supply Mains power quality should be that
transient/bur lines lines of a typical commercial or hospital
st environment.
±1 kV for
IEC 61000-4-4 input/output lines
Surge ± 1 kV line(s) to line(s) ±1 kV differential Mains power quality should be that

mode of a typical commercial or hospital
IEC 61000-4-5 ± 2 kV line(s) to earth
±2 kV common mode environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be

interruptions and that of a typical commercial or
(>95% dip in UT) (>95% dip in UT)
voltage variations hospital environment. If the user of
on power supply for 0.5 cycle for 0.5 cycle the E300 requires continued
input lines operation during power mains
interruptions, it is recommended
IEC 61000-4-11
40% UT 40% UT that the E300 be powered from an
uninterruptible power supply or a
(60% dip in UT) (60% dip in UT)
battery.
for 5 cycles for 5 cycles
70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50Hz/60Hz) magnetic should be at levels characteristic of
field IEC 61000-4-8 a typical location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
8
User manual – E300
Guidance and manufacture’s declaration – electromagnetic immunity
The E300 is intended for use in the electromagnetic environment specified below. The customer or the user of the
E300 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance Electromagnetic environment - guidance
level
Portable and mobile RF communications equipment should
be used no closer to any part of the E300, including cables,
than the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 Vrms 3 Vrms

IEC 61000-4-6 150 kHz to 80 MHz
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
Radiated RF 3 V/m 3 V/m distance in metres (m).
IEC 61000-4-3 80 MHz to 2.5 GHz Field strengths 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 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 assess 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 E300 is used exceeds the applicable
RF compliance level above, the E300 should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the E300.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
9
Recommended separation distances between
portable and mobile RF communications equipment and the E300 .
The E300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the E300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the E300 as recommended below, according to the maximum output
power of the
communications equipment.
Rated maximum output Separation distance according to frequency of transmitter

power of transmitter (m)
(W) 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.12 0.12 0.23

0.01
0.38 0.38 0.73
0.1
1.2 1.2 2.3
1
3.8 3.8 7.3
10
12 12 23
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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.
10
Reading Illustration
Do always follow the instructions to prevent injury to human body or
damage to the ESWT. Violation to the Cautions may lead to slight injury to
human body.
WARNING Do always follow the instructions to prevent injury to human body or damage
to the ESWT. Violation to Warnings may lead to serious injury to human body.
AUTHORIZED PERSONNEL The staff trained by Shenzhen Huikang Medical Apparatus Co., Ltd. or by the
company authorized by Huikang.
Operating personnel must follow all the rules in this manual while using the device.
Packing List
No. Description Qty
A Main unit 1
B Therapy head 1
C Power cable 1
D Instruction 1
E Footswitch 1
F Articulated arm 1
11
1. Foreword
E300
E300 is a therapeutic shock wave device specially designed for treatment of erectile dysfunction.
Figure 1 Overview

Medical Applications
Indications
E300 is appropriate for the shock wave therapy of the following diseases:
1. Erectile Dysfunction (ED)
It is the responsibility of the attending physician to adapt applications and treatment procedure according to
the state-of-the-art medical knowledge.
Contraindications
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:
1. Relevant coagulopathy
2. Pulmonary tissue in shock wave path
3. Intestinal gas in shock wave path
4. Tumor in shock wave area
5. Aneurysms in shock wave path
6. (Unclear) pathological changes
Relative contraindications are:

1. Infection in the treatment area
2. Invasive trauma in the treatment area
3. Hemorrhagic disease
4. Decompensated cardiovascular disease
Additional contraindications for the application of shock wave are:

1. Polyneuropathies
It is the responsibility of the attending physician to adapt applications and treatment procedure according to the
state-of-the-art medical knowledge. Before treating a pacemaker patient, he or she must carefully examine
whether the ESWT can be performed without risk based on the known and documented criteria.
Technical Information
E300 generates shock waves by means electromagnetic shock wave sources. It is also called electromagnetic
shock wave generator. The shock wave is conducted in water and is focused by an acoustic lens to effect on the
area of ailment.
Shock Wave Medical Application Principle
Shock wave energy from shockwave generator is focused on the targeted area of human body. The pressure formed

by the focused energy shall cause physical and physiological changes to human tissues. Hence, the targeted area
can be treated.
In andrology, shock wave can cause a series of physical function to treat the diseases. Up to now, this has
been proved in clinical applications.
■ Improve penile hemodynamics
■ Stimulation on cells and red blood cells to improve oxygen function and accelerate microcirculation
■ The clinical trials have proved that it is safe if the shock wave is used correctly. There is no case of irreversible
damage during clinical verifications.
Shock wave energy from shockwave generator is focused on the targeted area of human body. The pressure
formed by the focused energy shall cause physical and physiological changes to human tissues. Hence, the
targeted area can be treated.
1. The resistance from the human tissues against focused energy will cause damage to the tissues.
2. The tissues or bones around the focus in the shock wave path shall change by the extrusion and
expansion force, shocking effects from shock wave energy.
Physical effects in bone treatment have been proved in clinical trials.

1. Loosen the adhesive periarticular soft tissues.
2. Stimulate and improve the oxygen function of blood red cells. Accelerate the microcirculation.
3. Relieve pain in bones.
The clinical trials show that it is safe if the shock wave is used properly. There is no case of irreversible damage to
bones and soft tissues.

2. Safety
Responsibility of Manufacturer
Regardless of the specific requirements set by relevant liability standards, Shenzhen Huikang Medical
Apparatus Co., Ltd assumes responsibility under the following conditions only:
Assembly, adjustment, maintenance and modifications are performed only by Shenzhen Huikang
Medical Apparatus Co., Ltd personnel or persons authorized by Shenzhen Huikang Medical Apparatus
Co., Ltd.
Electrical installation of treatment room complies with applicable national
standards Operation of E300 is in accordance with valid operating manual.
Users’ Responsibility
Before activating the E300, each user must read and understand the operating instructions. Before each
treatment, the user must ensure that the E300 is in proper working order, in order to avoid putting the patient or
a third party at risk.
Each user must always follow the instructions given in this manual while operating the E300.
Safety for Patient
Operation of the E300
Do not operate the E300 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 will prevent the
patient from being startled and making involuntary movements during treatment.

Safety for Operating Staff
Training Operating Staff
Shenzhen Huikang Medical Apparatus Co., Ltd offers comprehensive training on the E300 for
physicians and operating staff alike.
Under no circumstance should untrained or unqualified personnel operate the E300. Training
is provided by authorized staff of Shenzhen Huikang Medical Apparatus Co., Ltd.
Duty of Operating Staff
Both operating staff and cleaning staff should apply utmost care when handling the E300.
Before activating the E300, the operator should have completely read and understood
the operating manuals.
Cleaning and Disinfecting
Disconnect power supply before cleaning and disinfecting the E300. Sterilize the cushion
surface with the disinfector and medicament without rotting the latex or covered by
disposable surgery cloth. A new piece of cloth should be used for each new patient to
prevent from mutually catalytic infection of hepatitis bacteria and skin disease.

Safety for E300
Electromagnetic Compatibility
E300 complies with EMC requirements according to IEC601-1-2, except during the triggering and generation cycle
of the shock wave release. (According to IEC60601-2-36)
Shock wave release may cause interference with other devices. Keep
the E300 away from working ECG monitors and other similar electronic
devices while shock wave is releasing.
Environment
Do not use E300 in inflammable or explosive environment, which may cause by gas from anesthetics, cleaner
or disinfectants.
Reflection and refraction at contact surface between coupling cushion and air may damage coupling cushion.
Electrical Installation
The electrical installation should comply with local government requirements.
Disconnect switch should be installed between the device and power supply. The disconnect switch should
comply with relative requirements in IEC328 and cannot reset automatically. The capacitor should be not less
than 10A. The device cannot be connected parallel with other instantaneous heavy loading electrical devices.
E300 needs function and protective grounding installation with independent grounding cables. Grounding
resistance≤4 ohms.
Operate the E300 only in an appropriate area where the electrical installation complies with applicable
national installation standards.
WARNING The installation of the E300 shall be conducted only by authorized persons.
Both the protective earth terminal and the functional protective
earth terminal shall be connected properly before being activated.
WARNING After installation or reinstallation, the E300 shall be tested in terms of

electrical safety.
Refer to Safety check chapter of this manual for more detailed instructions.

Transportation
Before transportation, the E300 must be disconnected from all external sources.
The E300 must be held by the handle while moving.
Before transportation, all kinematic joints of the moving body must be locked.
Before transportation, all power to the therapy device and the outside must be removed.
Use of coupling agent
The coupling agent should be coated evenly on the surface of the cushion, and there must be no air bubbles.
When joining the patient to the cushion, there must be no air bubbles between the two.
During the treatment, the operator must frequently check the joint between the patient and the cushion and pay
attention to whether there is any abnormality.
If the patient's skin is abnormal, stop triggering the shock wave immediately.
WARNING Shock waves can only be triggered with the coupling agent.
There should be no air bubbles between the cushion and the patient’s skin.
The interface between the cushion and the air bubbles will cause
refraction and reflection of the shock wave, and this refraction and
reflection will damage the cushion and reduce its service life.
Use of shock wave
Attending physicians should know well about the latest indications, contraindications, and side effects of the
device. For example, patients with hemolytic disease must not be treated with shock wave.
The muscle in the shock wave path will attenuate shock wave energy. The rest energy will be absorbed by
bone.
The dose of the shock wave is related to the tissue hematoma. However, it cannot be concluded that a higher
trigger frequency of the shock wave will have side effects. Although it has not been scientifically proven,
medications, high age, high blood pressure or weak blood vessels (especially the kidneys) increase the risk of
side effects in shock wave treatment. However, due to excessive shock wave intensity can cause hematoma,
sensitive renal soft tissue blood vessels have a greater risk of damage. For this reason, the dose of the shock
wave must always be controlled to the lowest possible level. While increasing the intensity of the shock wave,
the frequency at which the shock wave is triggered must be reduced.
WARNING The coupling needs to be put evenly on the outer surface of the cushion
without any bubble.
There should be no air bubbles between the cushion and the patient’s skin.
During treatment, the operator must always check joint positions where
the cushion is connected to patients, and check whether there is any
abnormality.
If the patient's skin has any abnormality, operator should immediately
stop triggering shock waves.

WARNING Shock waves should be triggered in coupled state only.
Reflection and refraction at contact surface between coupling cushion
and air may damage coupling cushion.
Protective grounding should be installed before starting the machine.
Electrical safety should be tested after installation or relocation of
E300.
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 the treatment.
If shock waves are directed into air-filled organs, such as the intestinal tract or the lungs, tissue damage can
ensue. Notice 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 tissue hematoma. However, it should not be ruled out that high shock wave release frequency
will influence the occurrence of adverse effects. Although this has not yet been proven by scientific means,
patients at relatively young age and advanced age, patients with high blood pressure or vessel cirrhosis (especially
in the renal area) can increase the risk of adverse effects. The sensitive vessels in the renal parenchyma are
particularly at risk, since lesions caused by excessive shock wave intensity can result in hematoma. For this reason,
the shock wave dose must always be maintained as low as possible.
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. When shock
waves are being triggered; it will produce a noise. The operator
should warn the patient before starting the treatment.
WARNING Pressure pulse will cause harm to heart.

When the shock wave is going through organs with air, such as
intestines, lungs and so on, it will cause damage to tissues.
It’s a must to avoid shock waves’ impact on lung and heart.

The operator must pay attention to any movement. These movements
may be hazardous to operator and patient.
Labels
Referring to user manual
～ Alternating current
FU Fuse
Caution
Type B medical device
Nameplate
20
Equipotential grounding terminal must be
connected to the ground wire during installation.
Warning: dangerous voltage
Sign of the handle connecting the treatment head to the

main unit
Loose
Locking
Indication of the direction of the treatment head

inserted into the articulated arm
Add water or reduce water in the water tank
The connector of footswitch
Water indicator
From top to bottom, high water level, medium
water level, low water level
Power interface of the articulated arm
21
Automatic reset switch indicator
Anticlockwise rotate to this sign to add

water in the water tank
Clockwise rotate to this sign to reduce

water in the water tank
Unrecyclable
22
3. Device Description
Structure
Figure 2 Structure
Structure of E300.
A. Main Unit
B. Shock wave therapy head
C. Trolley
D. Articulated arm
E. Footswitch
23
Main Unit
Figure 3 Main unit
Figure 4 Back view
Table 3
Label Description
A1 Function panel
A2 Adapter converter
A3 Thermal outlet
A4 Water level indicator
A5 Water in/ out button
A6 Water in/ out port
A7 Foot switch port

A8 Articulated arm port
A9 Equipotential terminal
A10 Power supply port

LCD Screen
Figure 5 LCD screen

No. Buttons Functions
Clearance
Click this button to clear the current
count value
Preset trigger times

Range: 0-3000
Adjust preset trigger times

When press this button, the trigger times
A1 will change by 100 times in the range of
0-3000
Adjust frequency
Press this button to adjust the trigger
frequency which will change by 10 times

Frequency display
Range: 60-180times/ min
Adjust energy level

Energy level: 0-10
Energy level display

The 0 level corresponds to 0kV, the 1
level corresponds to 7kV, and the 10 level
corresponds to 12kV
Stop /start continuous trigger
A1
Add/ decrease water
Increase/ decrease the mechanical arm

The travel distance is 150mm
Exhaust air
High voltage should be started first to
start air exhaust function;
It should be shut down when the air is
exhausted
Function switch button
Click this button to select the treatment
mode:
There’re 2 mode for 2 individual sites.
The parameters of the treatment mode
can be adjusted.
Save prescription button
Click this button to save the current
prescription parameters

Trigger count value
It’s declining count mode. When the
count value is 0, it automatically stops
triggering
Malfunction information
Table 5
No. Alarm information Description
1 ER-01 Water system components failure
2 ER-02 HV unit failure
3 ER-03 High voltage pulse control components failure
4 ER-04 Low water level failure
5 ER-05 Safe outage inspection failure

Note:
① The text message "Er-01" appears on the touch screen, indicating that the temperature of the
waterway is too high, and it is temporarily not allowed to generate shock waves. There is no
need to shut down the machine, and the temperature can be lowered through natural
cooling or water up and down operations. After the temperature is lowered (the prompt
message is no longer displayed), the machine can operate normally.
② The text message "Er-02" appears on the touch screen, indicating that the internal
temperature of the HV unit is too high, and it is temporarily not allowed to generate shock
waves. After the temperature drops (the prompt message is no longer displayed), the
machine can operate normally.
Connectors for Power Supply and Water System
Figure 6
Table 6
Label Part Name Description
A6.1 High water level indicator High level indications of the water tank
A6.2 Middle water level indicator Middle level indications of the water tank
A6.3 Low water level indicator Low level indications of the water tank
The switch is pulled to the left to add water.

A6.4 Water in/ out switch
The switch is pulled to the right for drainage.
A6.5 Water in/ out port Add or drain water from the water tank
External foot switch, press the trigger, and press
A6.6 Foot switch port (optional)
the stop trigger again.
External display interface An external display can be used, and the external
A6.7 (optional) display function is the same as the main display.
Articulated arm port (optional) Control the articulated arm
The switch is in the “○” position to disconnect the
power:
A6.8 Power switch
The switch is in the "丨" position to turn on the
power.
A6.9 Power socket Power input interface AC 220V 50Hz
A6.10 Equipotential terminal Connected to equipotential grounding wire

Therapy Head
Figure 7
Table 7
No. Part Name Description
B1 Therapy head Contacting with the patient
Exhausting the air in the cushion (there’s a small hole that can be
B2 Air exhaust
seen in the edge of the cushion)
B3 Converter Connecting to the main unit
B4 Locking knob To fix the therapy head on the main unit

Articulated Arm and Main Unit
Figure 8
Table 8

C1 Coupling agent hanger For placing the coupling agent
C2 Handle Moving the device
C3 Therapy head hanger For placing therapy head
C4 Storage box Two storage boxes
C5 Footswitch Control shockwave trigger
C6 Brake Breaking the wheel
C7 Therapy head Treatment device
C8 Articulated arm For control the therapy head
Handle for adjusting
C9 Control the arm
articulated arm
Handle for locking the therapy
C10 Fix the therapy head on the main unit
head

1. Counterclockwise rotate it to remove the therapy
Handle for locking the therapy
C1 head
head
2. Clockwise rotate it fasten the therapy head
Handle for locking the Counterclockwise or clockwise rotate it to adjust the
C2
movement of therapy head position of therapy head
Handle for adjusting the
C3 Press it to adjust the position of the whole arm
position of articulated arm
Caution: Move articulated arm away from main unit in case of collision risk before moving it down.
4. Operating Instructions
Choose the prescription Save prescription Using prescription
Note:
1. Before single trigger, the HV must be started first.
2. After save and use of the prescription, the prescription mode will exit automatically.
3. The blank button which shows no prescription mode means the status in exiting mode.
4. When the machine is in prescription selecting mode, the HV and trigger will be stopped automatically; the
software cannot start HV and trigger; the water system and parameter setting can be used normally.

Observe Safety Instructions and Rules
Attending physicians should read this manual carefully and observe the safety instructions and rules in it
before operating E300.
Observe all the local rules and regulations.
Routine check
Check all the functions before giving treatment to patient, this is to avoid potential injuries to the patient because
of machine malfunction.
Check the Following Parts:
1. Cushion
2. All movement parts
3. Power cables and connectors
4. Function panel
5. External display screen
6. Foot switch (optional)
Do not start E300 if the protective grounding is not installed or not well
connected.
WARNING Only the authorized personnel can do the above checks. Authorized
personnel include:
Trained by Shenzhen Huikang Medical Apparatus Co., Ltd. or
Trained by the company who are authorized by Shenzhen Huikang
Medical Apparatus Co., Ltd to give training.
Please do not use E300 if any defective parts are found during the routine
check.
Routine safety inspection

Before starting E300, the following routine safety inspections should be carried out;
Whether the protective grounding is good;
Whether the movement parts move freely;
Whether the cushion is intact and the air in the cushion is exhausted.
Air exhaust of the cushion:
Remove the bubbles in the cushion according to the following ways.
1. Click the "High Voltage Start" button, the water cycle will automatically start;
2. Tilt the treatment head upward (about 30°) to align it with the exhaust port. Bubbles can gather at the exhaust
port. Click the "Air exhaust button", and the touch screen displays "Exhaust";
3. Tap the cushion to exhaust air. Click the "Air exhaust button" again to close the air exhaust state when there
are no air bubbles in the cushion;
The use of coupling agent

1. Coupling agent should be evenly coated on the outer surface of the cushion without air bubbles.
2. There should be no air bubbles between the patient with the cushion.
3. During the treatment, the operator must frequently check the joint between the patient and the cushion to
check whether there is any abnormality. Stop the shock wave immediately if the patient’s skin is abnormal.
Warning
1. Do not start the E300 if the protective grounding is not installed properly.
2. Only authorized personnel can perform the above inspections.
3. Do not start the E300 If any damage of the equipment is found during routine inspections.
4. Do not trigger the shock wave ff there are bubbles in the cushion.
Preparation for the Treatment
Patient
1. Double confirmation about the contraindications with patients
2. Inform patients about the noises during the treatment.
Device
1. Clean the surface of cushion.
2. Turn on the power supply.
3. Fill the cushion with water
4. Remove the air bubble from cushion.
Filling cushion with water

1. Inject a certain amount of water into the cushion through the water in/ out button;
2. Select the high voltage start button to make the machine ready for triggering, at which point the water
cycle is automatically turned on. The water is filled into the cushion through the water inlet from the
water tank.
3. Air exhaust: take the exhaust pipe to the highest point, press the air exhaust button and the air is
exhausted from the exhaust pipe.
4. After the air in the cushion is completely removed, press water in/ out button to control the amount of
water required in the cushion.
The touch screen will show “Highest” when the water reaches to the limit
value in the cushion, and the button will be invalid.

Note
Water in button
 Water in/ out

1. Connect the “water in/ out port” to the 6mm water pipe.
The other end of the water pipe is connected to the water container (more
than 500mL);
2. The water in the cushion must be drained before draining the water tank.
Select “Water in/ out button", the water in the tank flows to the water
container. Recover the button after draining the water.
3. The water container should be filled with more than 500mL of water
which should higher than water in/ out port, and then select water in/ out
button to add water. When the highest water level indicator is on, stop
adding water, then press the button and unplug the small water pipe.
Note: it should be distilled water.
 Degassing
1. Click the "High Voltage Start" button, the water cycle will automatically
start;
2. Tilt the treatment head upward (about 30°) to align it with the exhaust
port. Bubbles can gather at the exhaust port. Click the "Air exhaust button",
and the touch screen displays "Exhaust";
3. Tap the cushion to exhaust air. Click the "Air exhaust button" again to
close the air exhaust state when there are no air bubbles in the cushion;

Degassing
Water in and out
Figure 12
WARNING Please do not trigger shock wave if there are air bubbles in the water.
Positioning
The treatment plan depends on the different locations.

Adjust the height of the cushion, coat the cushion with ultrasound coupling gel; the therapy head is
placed around the penis corpora cavernosa and around the feet.
For the treatment of the penis, it is to pass the shock wave energy to the treatment area, using
energy level 9 to treat the bottom of the penis and energy level 8 to treat the penis body, with 600-
900 shocks for each treatment area. Each patient or lesion should not take more than 1000 shocks.
Remarks:
The energy level should be adjusted properly for the comfort of each patient which is usually set to 5
– 9.

Start treatment
1. Treatment parameters setting

(1) Using the prescription (see page 24)
(2) Setting the parameters directly
2. Setting parameters
(1) Adjusting energy level:
Click or to increase or decrease the energy level.
(2) Adjusting frequency:
Click or to increase or decrease the frequency.
(3) Adjusting the preset shocks value:
Click to adjust the total shocks.

(4) Adjusting the trigger count
The trigger count can be cleared at any time. When the trigger count is 0, the continuous trigger signal will be invalid
automatically and the high voltage start is still valid. Click to recover the total counts as the preset number.
3. Treatment
After setting all parameters, put the therapy head on the treated area.
(1) Set the energy level to be > 0. The high voltage will automatically start.
(2) Click , the shock wave will continuously be released.
(3) Click to stop triggering shock wave.

(4) Adjust energy level to be 0. It will stop triggering.
Remark:
There’s a save menu that can be used to save current treatment protocol. It can save total 2 protocols, and the
new protocol will cover the current saved protocol.
4. Adjusting the height of cushion
(1) Press to inject the water into the therapy head.
(2) Press to decrease the water in the therapy head.
5. Adjusting the articulated arm
Press to increase the articulated arm.

Press to decrease the articulated arm.
1. Under non-emergency circumstances, the machine should stop trigger first,
reduce the energy level to 0, and click for one time to release the
Warning residual voltage completely.
2. During treatment, the operator must pay attention to the patients all the
time. The treatment should be stopped immediately if the patients feels
uncomfortable or there’s any emergency.
End Treatment
1. It will stop automatically when the count end.
2. Take the therapy head away from patient.
3. Decrease the energy level to 0 and release high voltage totally.
4. Turn the power switch to “0” position and cut off the power.
5. Clean the patient’s skin.
6. Clean the cushion.
WARNING Don’t skip step 2.

5. Technical Specifications
Dimensions
Main unit weight 27 kg

Trolley weight 33 kg
Floor space (width × depth) 780mm x 620mm
Height 1100mm
Power supply
Voltage AC 220V
Frequency 50/60Hz
Resistance ≤0.3Ω
The device needs to be installed with protective grounding and reliable connection with the public network of the
installation site.
The device cannot be in parallel use with other instaneous heavy loaded electrical devices.
Power capacitor
Power capacitor ≤1000VA
Do not power the E300 by supply mains which is not in accordance with
Warning the above-mentioned specifications.

Use independent or proper stable power only
Environment
Room temperature
During treatment 10℃-30℃
In storage (without water) -10℃-75℃
Relative humidity
During treatment 45-75% (no coagulation)
In storage 10-75% (no coagulation)
Atmospheric pressure
During treatment 86-106 kPa
In storage 86-106 kPa
Caution: drain the water in the water tank When it’s in storage.
Shock wave parameters

Therapy head
Principle Electromagnetic
F2 to surface of therapy head cup 75mm
Shockwave rising time ≤3us
Pressure 1~15MPa
Energy Density Max. 0.15mJ/mm2
High voltage pulse box
Frequency 80kHz
Voltage 7-12kV

6. Maintenance
Safety check
Regular safety check

Safety checks mean maintenance and adjustment at regular intervals.
Safety checks guarantee the safe and reliable operation of E300.
Shenzhen Huikang Medical Apparatus Co., Ltd. recommends that the safety check be performed annually.
Occasional safety check

E300 shall be tested when any of the following happens:
● Installation
● Relocation
● Servicing
● Consumable/parts replacement
The periodic safety check list and the occasional safety test list will be provided by Shenzhen Huikang Medical
Apparatus Co., Ltd. free of charge on request.
WARNING Only authorized persons may conduct safety check on E300.

Authorized persons are exclusively persons who have been trained by
Shenzhen Huikang Medical Apparatus Co., Ltd. or by a company authorized
by Shenzhen Huikang Medical Apparatus Co., Ltd.
Safety checks conducted by unauthorized persons can result in
critical injury to persons and/ or serious damage to the E300.
For any maintenance operations, replacement of consumables and
fuses, stop the trigger before operation, reduce the energy level to 0,
click the continuous trigger button, release the residual voltage, and
then close the continuous trigger.
Daily maintenance
a) Check whether the connections of the ground wires in the equipment are tight at least once a month;
b) Each time before starting the equipment, check whether the connections of each grounding wire is normal and firm,
and whether the equipment is running abnormally.
c) Keep dry and pay attention to moisture.
d) Replace the water in the water tank every month.
Only authorized persons may conduct the above maintenance.
Cleaning and disinfection

E300 should be cleaned and disinfected before each patient is treated to prevent viruses such as hepatitis B and skin
diseases from causing contact cross-infection.
Operation methods:
1. Cut off the power supply of the device.
2. Clean and disinfect the device according to the following methods:
Cleaning: use a sponge or soft cloth to wipe off the dust and dirt on the outer surface of the device.
Disinfection: after cleaning, wipe the outer surface of the device with a sponge or soft cloth dipped in disinfectant (do not
dip too much disinfectant liquid on the sponge or soft cloth, so as to avoid dripping into the equipment and causing

malfunction or danger). Available disinfectants include: medical alcohol, formalin disinfectant and so on. Before each
treatment, the appearance of the following application parts of the device should be disinfected:
1) Shock wave source (including cushion);
2) Any other equipment that may touch the patient and the operator.
Warning
Before cleaning and disinfection, the power plug of the equipment must be unplugged.
Do not use gas or spray disinfectants to clean or disinfect the device.
Do not allow liquid to penetrate the inside of the device.
Follow the safety instructions provided by the disinfectant and detergent manufacturers.
Follow the regulations on disinfection and cleaning in national laws.
Waste disposal
This device will produce the wastes of cushion, ultrasonic coupling agent, HV unit, waste water and other consumables,
and may produce pollutants such as foam packaging materials, energy storage capacitor electrolyte, peeling off wire
insulation, etc. In addition, the equipment is scrapped after its service life expires. But the wastes number are extremely
small.
Although these wastes are classified as having no or almost no possibility of being injured according to the severity of the
possible hazards, they still have a higher hazard value due to frequent replacement of consumable parts. It will be
destructive to the environment to a certain extent. Therefore, these wastes must be properly treated to reduce the
hazard value.
Waste treatment method

After the service life of the device expires, it must be disposed of in accordance with local applicable regulations.
Different materials, such as packaging, electronic waste, plastics, metals, waste water, etc., must be disposed of in
accordance with relevant national laws.
To inquire about how to avoid personal injury and environmental pollution, please contact Shenzhen Huikang Medical
Apparatus Co., Ltd. before the end of the device’s life.
Replacement of consumables
The consumables include the following items:

A. HV Unit
B. Therapy head
Only the authorized persons can replace the consumables for E300.
Replacement of fuse
Fuse specification
Fuse No. Value Location Size
1FU 5A Power supply input socket Φ5mm×20mm
2FU 5A Power supply input socket Φ5mm×20mm
3FU 5A PCBA board Φ5mm×20mm

Maintenance
Normal failure
Maintenance shall be performed as often as necessary to guarantee the safe and reliable operation of
Failure Analysis Methods
E300.
Trigger failure The lifetime of HV unit is over. Replace HV unit
Multiple shocks The voltage is too high or the HV unit’s Replace HV unit
in one trigger lifetime is over.
There’s trigger Blue flash can be seen through the cushion. Replace therapy head
but no The EM disk is broken.
shockwave
Shenzhen Huikang Medical Apparatus Co., Ltd. provides recommended procedures for maintenance.
Routine maintenance:
Lubricate the mechanical parts and wipe off the dust on the surface of device. Check all the cable
connections monthly.
Check the protective grounding before powering on the machine. Keep the device in a dry and clean
environment.
WARNING Only authorized persons may conduct safety check on the E300.
Authorized persons are exclusively persons who have been trained by
Shenzhen Huikang Medical Apparatus Co., Ltd or by a company authorized
by Shenzhen Huikang Medical Apparatus Co., Ltd.
Safety checks conducted by unauthorized persons can result in
critical injury to persons and/or serious damage to the E300.
Replacement of fuse
No. Location No. Specifications Size
1 1FU F5AL250V
2 2FU F5AL250V Φ5mm×20mm
3 FUSE F5AL250V
When replacing the fuse, cut off the power first, and replace the fuse of the same specification in accordance
with the electrical drawings or the actual machine.

Stability test
The lifespan of the devices is 8-year, consumables excluded. As long as the device is in use, the following stability
test should be carried out periodically.
Use a noise tester to test the noise of the device during operation which should not exceed 90 decibels;
(discharge noise is not included)
Procedures for detecting deviations of physical variables that increase the

risk of patients
1. The detection procedure of excessive absorbed energy caused by wrong counter display
1.1 During the treatment process, the counter reflects the dose received by the patient, and the count is reduced
once for each pulse impact. However, if the counter fails, for example, it does not increase, the actual number of
impacts may be greater than the preset display value. If the doctor is not paying attention, it is possible for the
patient to receive a dose that greatly exceeds the preset value.
The possible reasons for the error are:
a) The counter circuit is malfunctioning.
b) The counter circuit is affected by external interference, and the numbers do not count regularly.
c) Misoperation of digital reset, without noticing the accumulation of previous counts.
1.2 Test method
Use a stopwatch to measure whether the trigger value in a certain period of time is consistent with the increase in
the counter display.

7. Reference:
Abbreviations
Abbreviations Meaning
Device E300 Extracorporeal Shock Wave Therapy System
Glossary
Glossary Meaning
HV Unit High voltage capacitor box
Coupling gel Medium used to eliminate air between patient’s skin

and coupling cushion. Air impairs effect of shock wave.

Transport Sign
Fragile Keep Up Keep Dry No Rolling
Total case no.
Storage Condition
Barycenter
E300 Shock Wave Therapy System
Cubage：
G.W：
N.W：
：
Shenzhen Huikang Medical Apparatus Co., Ltd.
Add of Manufacturer: 5F and Room 101, 1F, Zone 2, Building A, Haikexing

Industrial Park, No.16 Baoshan Road, Jinlong Avenue, Liulian Community,
Pingshan New District, Shenzhen, China
Tel: 86 755 25515460
Fax: 86 755 25515362

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E300 EXTRACORPOREAL SHOCK WAVE

User Manual Version A.1

For Any Service Support Please Contact

VOLLWERT MEDICAL EQUIPMENT TRADING LLC.

PO Box : 64162, M7, Block A, Al Khallafi Building,

User manual – E300 2

Manufacturing site: 5F and Room 101, 1F, Zone 2, Building A,

No part of this operating manual may be reproduced or transmitted

User manual – E300 3

User manual – E300 4

Authorized representative in the European Community:

I hereby declare that the following products manufactured by us

Conformity Assessment Route:

Shenzhen, Feb 2018.

User manual – E300 5

User manual – E300 6

Guidance and manufacture’s declaration – electromagnetic emission

User manual – E300 7

Surge ± 1 kV line(s) to line(s) ±1 kV differential Mains power quality should be that

Voltage dips, short <5% UT <5% UT Mains power quality should be

Conducted RF 3 Vrms 3 Vrms

Where P is the maximum output power rating of the

Rated maximum output Separation distance according to frequency of transmitter

0.12 0.12 0.23

User manual – E300 12

Relative contraindications are:

Additional contraindications for the application of shock wave are:

Shock Wave Medical Application Principle

User manual – E300 13

Physical effects in bone treatment have been proved in clinical trials.

User manual – E300 14

Electrical installation of treatment room complies with applicable national

standards Operation of E300 is in accordance with valid operating manual.

Safety for Patient

Operation of the E300

Informed Consent of Patient

User manual – E300 15

Training Operating Staff

Duty of Operating Staff

Cleaning and Disinfecting

User manual – E300 16

The electrical installation should comply with local government requirements.

WARNING After installation or reinstallation, the E300 shall be tested in terms of

User manual – E300 17

Use of coupling agent

Use of shock wave

User manual – E300 18

WARNING Pressure pulse will cause harm to heart.

User manual – E300 19

Referring to user manual

Type B medical device

Warning: dangerous voltage

Sign of the handle connecting the treatment head to the

Indication of the direction of the treatment head

Add water or reduce water in the water tank

The connector of footswitch

Power interface of the articulated arm

Anticlockwise rotate to this sign to add

Clockwise rotate to this sign to reduce

Figure 3 Main unit

Figure 4 Back view