Please read this manual carefully before using.

Extracorporeal Shock Wave Device

-----RH-CJB-B

User Manual

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 Contents
Contents....................................................................................................................................................................... II
Foreword................................................................................................................................... 错误！未定义书签。
Introduction.................................................................................................................................................................3
I. Product Profile.........................................................................................................................................................3
II. Main Specification................................................................................................................................................. 3
III. Main Structure and Components.......................................................................................................................4
IV. Application Range.................................................................................................................................................4
V. Contraindications and Side-effects.......................................................................................................................4
VI. Attention and Warnings.......................................................................................................................................4
VII. Explanation for Figures, Symbols, and Abbreviations................................................................................... 6
VIII. Installment Instruction..................................................................................................................................... 6
IX. Introduction for Use.............................................................................................................................................7
X. Maintenance......................................................................................................................................................... 12
XI. Storage and transportation requirements....................................................................................................... 14
XII. Lifetime of product...........................................................................................................................................14
XIII. Environmental protection and others........................................................................................................... 15
XIV. Circuit diagram, component list.....................................................................................................................15
XV. Simple malfunction elimination....................................................................................................................... 15
XVI. Parts list............................................................................................................................................................15
XVII. Electromagnetic compatibility information................................................................................................15

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 Introduction
I. Product Profile
1.Brief introduction: The extracorporeal shock wave Device (hereinafter referred to as ‘the

equipment’) can transfer the air-pulse wave produced by the compressor into stable ballistic pulse

waves and conduct them through physical medium like air and liquid on the human body to bring

about biological effects. The pulse wave is obtained under the sudden energy release with much

power, which can instantly increase the shock pressure and conduct energy at high speed.

II. Main Specification

1. Requirements on working condition:

a) ambient temperature: ＋10℃～＋40℃;

b) relative humidity : 30％～75％;

c) atmospheric pressure scope: 700hPa～1060hPa;

d) rated voltage: a.c. 220V±22V; rated frequency: 50Hz.

2. Rated input power: 155VA.

3.Display mode: LCD touch screen display.

4.Output channel: single channel output.

5.Collision frequency:

a)Single mode: collision frequency is one impact;

b)Manual pulse: the collision frequency is adjustable from 1 to 15 times, the stepping is 1; the

pulse is adjusted from 1 to 100 times, and the stepping is 1 time;

c)Automatic pulse: collision frequency is adjustable from 1 to 15 times, stepping is 1

d)Automatic intermittent: collision frequency is adjustable from 1 to 15 times, stepping is 1;

pulse is adjusted from 1 to 100 times, stepping is 1 time; interval is adjusted from 10 to 2000 ms,

stepping is 10 ms

6.Working pressure adjustment range: 150kPa ~ 400kPa, step 10kPa, tolerance ± 10%;

7.Number of impacts: 10 times to continuous infinite impact, short press stepping 10 times,

long press stepping 100 times;

8.Main unit: length: 460mm, width :390mm, height: 230mm, tolerance ±10%;

9.Trolley: length:545mm, width :490mm, height:870mm, tolerance ±50mm;

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 10.Treatment head:

a)Treatment head 1: diameter :20mm, tolerance ± 15%;

b)Treatment head 2:diameter :15mm, tolerance ± 15%;

c)Treatment head 3:diameter :14mm, tolerance ± 15%;

d)Treatment head 4:diameter :10mm, tolerance ± 15%;

11.Control handle: length: 195mm, height: 80mm, tolerance ± 30mm;

12.Rubber gas pipe: length :2400mm, tolerance ± 5%;

13.Counter: Record the number of impacts during treatment, tolerance ± 5%;

14.Energy density: ≤0.63mJ/mm2, tolerance ±20%;

15.Working noise ≤ 60dB.

III. Main Structure and Components

It is mainly composed of a host, a treatment head 1 to 4, a control handle, and a rubber gas

delivery tube.

IV. Application Range

It can be used as the assistant treatment for the pain of Periarthritis of shoulder

V. Contraindications and Side-effects

Contraindications: not suitable for patients

1. Pregnant or nursing;

2. Physically susceptible;

3. with broken skin or skin disease;

4. with underlying disease of heart, liver, kidney and hematopoietic system; mentally ill; with

built-in heart pacemaker or other metal medical instrument.

VI. Attention and Warnings

1. Attention

1) Please make sure that you have read carefully and totally understand all the information in

this manual before the first using. It is recommended to operate the machine under the guidance of

the doctor.

2) For proper operation and make the best use of the machine, it is basically required to know

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well about the instructions in the manual.

3) Having a complete knowledge of the information in this manual can ensure you are able to

take rapid and effective measures when the machine breaks down.

4) Children, the elder people and patients with acute diseases or unable to take self-care shall

take the therapy under the guard of the doctor.

5) Please use the special accessories like metal bullets and headpiece, and avoid replacing with

repairs from other manufacturers, or it may not match with the equipment and influence the output

stability and safety which in turn will impact the therapy effect and damage the machine.

6) The contents in this manual is the basic knowledge for making full use of the equipment.

7) The impulse handpiece can only be used by experts and trained professionals.

8) The user shall be responsible for the correct operation of the handpiece.

9) The user shall be responsible for positioning the proper treating point.

10) Please make sure to switch off the power before cleaning and maintaining.

11) After finishing the therapy, please clean and sterilize the handpiece and headpiece with a

alcohol cotton ball or a piece of alcohol cloth.

12) You can clean the metal bullet and trajectory with neutrally mild abluent or clear water, and

sterilize them with medical alcohol Please dry them under the sun for later use. It is suggested to

keep the maintenance once a week and you can also keep a maintained cycle based on your using

frequency.

13) Please keep about 1 m away from the short wave or microwave therapy equipment, or it

may cause unstable output.

2.Warnings

1)It’s forbidden to treat gaseous tissues and organs, macro-nerves, macro-vessels or body

parts near the spine or the head with the equipment.

2)There will be warnings on the display when the metal bullet has bounced for 2 million and

400 thousand times and can not be used any more. Please activate the buttlet and trajectory with

the activator appliance according to related information in this manual before continuing to use.

3)The activator appliance is available for one-time operation, so please contact us to buy the

adapted bullet and trajectory tube for later replacement.

4)The original test treatment head count of the therapeutic apparatus is less than 10,000 times,

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and the original test treatment head count is included in the treatment head life cycle.

note:

The company is not responsible for any damage to the therapy device caused by

disassembly, repair, or modification of the therapy device without the consent of the company

VII. Explanation for Figures, Symbols, and Abbreviations

1. Model BF application components 2. power off (general power supply)

3. power on (general power supply) 4. number limit of stacking layers

5. fragile 6. upward

7. Never exposed to the rain. 8. No rolling

9. Attention! Please check the attached 10. Landing protection (ground connection)

documents .

11. Nonionizing radiation

VIII. Installment Instruction

Host installation guide (main installation content is shown below)

1.Unpacking package;

2.Carefully get the treatment device and accessories from the box;
3.Check the contents of all the boxes to make sure whether they are damage or not
according to the packing list;
4.If some accessories are lost or damaged, please contact us as soon as possible;
5.Keep the original packaging for later use.
installation steps

1. Place the therapy device on the trolley;

2. The red dot on the impact pistol connection line should be aligned with the red dot on the

therapy device;

3. Gently insert the cable into the joint, and then it will be locked immediately. When it is pulled

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out by hand, it will not fall off easily;

4.Place the impact pistol on the impact pistol bracket;

4. Make sure that the power outlet voltage is 220V and it is reliably grounded. Otherwise replace

the power supply;

6.Plug the power cord into the power input socket on the main unit. Plug the power cord into a

network outlet;

5. Turn on the power switch to use;

6. The removal method of the above accessories should first cut off the power of the therapy

device, according to the reverse steps of the connection method.

IX. Introduction for Use

1. Handpiece operation guide
1) Place the handpiecevertically upright to disassemble and be careful not to put it upside down or

horizontally to prevent the bullet from accidentally falling off.

2) Remove the applicator in a counterclockwise direction, then disassemble it and check that the

rubber band on the conductor is intact. If it is damaged, please replace it immediately or contact

our company or authorized dealer.

3) Turn and remove the impulse trajectory tube connected to the handpiecehandle. Take out the

bullet and trajectory gently.

4) Install the trajectory into the cavity tube and carefully keep the trajectory tapping direclty

toward the control handle. Turn in the counter-clockwise direction to install the cavity tube. Then

power on the handpiecewithout putting in a bullet to let the machine run for a few seconds to

warm up.

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5) Reassemble the handpiecein the above order adversely.

6) Clean the handpieceand ensure that no liquid left in the cavity.

7) Please handle the applicators gently while assemble and disassemble, or rudely operation may

cause the abnormal running.

8) Keep the applicator away from sharp objects.

2.Operational Instruction

1)Connect the power cable and power on the supply switch, then the system will begin

warming-up as shown in Fig2.

Fig2:Welcome Interface

2)After the welcome interface is finished, enter the treatment parameter setting interface, as

shown in Figure 3.

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 Figure 3:Treatment parameter setting interface

The treatment pressure, treatment frequency and number of treatments can be adjusted at the

treatment parameter setting interface.Then press after finishing setting, and there will be a
voice message informing you of the therapy will start. At this time, you can press the button to

begin the therapy and the digital window will show the present number of therapy times.

3)Click on the prescription in the treatment parameter setting interface to enter the treatment

site selection interface, as shown in Figure 4:

Figure 4:Treatment site selection interface

Click on the treatment site selection interface ,it can return to the treatment parameter

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setting interface.

4)Choose your treatment section and the system will enter the dispensatory selection

interface as shown in Fig.5. There are 150 dispensatories in total provided for your choice

Figure 5:Dispensatory selection interface

Click on the prescription selection interface at the treatment site ,it can return to the

treatment site selection interface.

5) Click on the treatment parameter setting interface ,you can enter the product details

introduction interface, as shown in Figure 6.Click on ,you can turn pages,Click on ,you

can return to the treatment parameter selection interface.

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 Figure 6:Product details introduction interface

6) 6)Press button into the setting interface as shown Fig.7.

Fig. 7 Setting interface

The setting interface can display the total working times of the equipment and the applicator

as well as the system time. When you upgrade your system, you can press the reset button to clear

the number of service times of the applicator(See the activator operation guide for details). You

can also calibrate the system on this interface.

7)The surface of the skin at the treatment site must be coated with an ultrasonic couplant

(enhancing the penetration of the shock wave). In order to evenly cover the energy of the shock

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 wave to the treated site, the trigger is constantly moved during the treatment.

8)Never treat the same pain point over 300-400 times.

9)The maximum energy during treatment does not cause uncomfortable pain to the patient, ie,

avoids exerting excessive pressure on the patient's skin.

Important Hint

▷ It is prohibited to remove the electronic/inflatable connector before downloading the inflation circuit.

Therefore, wait for 30 seconds after the power is turned off to discharge the gas-filled circuit.

The purpose of this step is to ensure the integrity of the O-ring implanted in the connector.

Instrument damage caused by the above conditions is not covered by the warranty.

X. Maintenance
1.Cleaning

Periodic cleaning can ensure the equipment a hygiene state and normal functioning.

Warning:

Flammable and combustible abluent and disinfectant may cause explosion.

Please power off the switch before cleaning and maintenance.

Please clean the machine with a wet cloth of soapy water or neutral mild detergent

Warning:

Note that never let liquid into the machine and catheters.

2. In addition to regular maintenance and cleaning of the treatment head to ensure safe and

effective treatment, the treatment device does not require any special maintenance. Unless the

treatment device does not work, special maintenance is required, and normal maintenance is

usually required.

3. To clean the outside of the chassis, simply wipe it with a little warm, soft cloth or clean with a

non-flammable, non-rough liquid liquid cleaner. The front console is cleaned in the same way.

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4. Do not place hot items, water, or liquids on the therapy device.

5. Please do not place the therapy device near the machine that emits electric fields, magnetic

forces or emits high electromagnetic force.

6. The treatment head, especially the probe of the treatment head, requires regular water or

alcohol to clean. Be careful when storing the treatment head at the end of each treatment

7. After cleaning the device case, please make sure the body is completely dry before starting the

operation.

8. The parts in contact with the patient are disinfected with a medical alcohol cotton ball after

each patient is treated.

9. Do not over-bend, stretch, twist, or bundle the power cord and rubber gas pipe during use. Do

not apply any heavy objects to prevent damage to the power cord and rubber gas pipe.

10. Keep the machine clean and if it is going to be left unused, check that it is powered off and

well-covered under the protective cloth to keep it dry and dust-free. And never place heavy objects

on the instrument.

11. Besides, it’s better to semiannually check the condition of the machine under the power-on

state for long time lying idle.

12. The O-ring along with the equipment needs to be replaced and maintened after being used for

25 million times. If there is damage due to no replacement, Xiangyu won’t provide the

maintenance for free.

13. Please contact us according to the warranty card for replacing the bullet and ballistic

trajectory in the handpieceafter it has impacted for 2.4 million times during the service cycle and

can not be used any more.

14. The service life of the treatment head is related to the maintenance of the equipment. Different

degrees of care determine the service life of the equipment. Treatment head damage due to

improper use is not covered by the normal warranty.

15. When the bullet and ballistic trajectory reach their service life, please replace with new ones

so as not to affect the normal work of the machine.

16. Return the equipment back to the factory every 2 years for maintenance to keep the machine

in a stable performance.

17. Replace the fuser

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1)Pull the main power cord plug out of the socket.

2)Lift off the fuse cover with a slotted screwdriver.

3)Remove the broken fuser off.

4)Replace with a new fuser in line with the parameters

5)Cover the fuser lid.

6)The type of the fuser is F5AL250V.

18.Please directly contact us or our customer department when there is trouble with the equipment

that needs professional maintenance or services from our company.

19.If you need any other services, please contact us.

20.If the power cord, rubber gas pipe or other fittings is damaged, please immediately stop using

the machine and promptly contactus or our authorized dealers. The replacement method can be

found in the installation instruction and user manual.

Warning:

Our company will not be responsible for any damage caused by disassembling, repairing

or changing the therapeutic device without our consent.

XI. Storage and transportation requirements

1.Transtportation, storage conditions: ambient temperature ：-10℃～+55℃

relative humidity：no more than80%

atmospheric pressure：500hPa～1060hPa

2. Transportation

Foam plastic is added between the Device and package to prevent from shock, violent vibration

and damp

2. Storage:The packed Device should be stored at a dry , non-corrosive gas ,well-ventilated

warehouse where the temperature is between -10 ℃～ + 55 ℃,relative humidity is no more than

85% .

XII. Lifetime of product

Lifetime of product：8 years.

Production date：see product certificate or product label.

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 XIII. Environmental protection and others
If the Device and its accessories are at the end of their normal service life or to be scrapped due to

improper clinical use. It may cause harm to the environment if handled improperly and should be

handled according to the local government's relevant laws and regulations on environmental

protection. Do not discard it at will.

XIV. Circuit diagram, component list

This apparatus is a precision instrument. The spare parts can’t be repaired by operator or user

except for fuses. In case of failure, it should be repaired by our company or maintenance dealer

authorized by our company, and must not be disassembled randomly.

XV. Simple malfunction elimination

Malfunction
Reason analysis Exclusion method Notes
phenomenon
Power is not plugged in.
Replug the power cord

The system is not Fuse is blown Change the fuse.

powered

Power line is not connected. Change the power line.

The treatment device Contact our company to replace

Impact pistol failure
does not work the impact pistol

Disassembly impact pistol

There is no energy
Projectile is blocked or worn Cleaning impact pistol pipe
output for shockwave
Change impact pistol

If you can not troubleshoot, please contact us according to the contact

information on the warranty card. Do not open the host to avoid damage to other
parts.
XVI. Parts list
See the packing list.

XVII. Electromagnetic compatibility information

Extracorporeal shock wave Device should install and use according to the electromagnetic

compatibility information in the appendix.

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1.Connection cable and switch must be provided by our company. All the power line
used in this equipment has been certified “CCC”
2.Warning:In addition to the connection cable and switch provided by our
company,the use of accessories from other company may increase shooting or decrase
noise immunity.
3.In order to ensure the shockwave therapy appratus can be used normally , shooting
won’t be increased and noise immunity won’t be decreased, please select the
connection cable and relative accessories provided by our company.
4.The use of accessories, cable with shockwave therapy appratus may cause an
increase of shooting of equipment or derease of noise immunity.
5. Extracorporeal shock wave Device should not be used close to or superimposed
with other equipment. If it must be closed or stacked , it should be observed and
verified to operate normally under configuration in which it is used.
6. Basic performance: The operating mode does not change unexpectedly.
7.When Extracorporeal shock wave Device is used normally,it may cuause
electromagnetic interference to other diagnosis or therapy devices. Please keep a
proper distance from other devices and observe the correctness of the data carefully
during the use of equipment.
8.The protable and mobile radio frequency communication devices may be affected.
In the normal use of this therapy appratus, it is remommended to stay away from the
protable and mobile radio frequency communication devices or keep them closed.
9. Meet the cable information required by YY0505-2012 36.201 and 36.202.
NO. Name of cable Length（m）
1 Power line 1.5
2 Rubber gas pipe 2.0
10. When Extracorporeal shock wave Device is working, it may cause harmful effects
to other devices or system. In any case, in order to avoid any interference problems,
we suggest you to stay away from the key equipment monitoring critically ill patients
and use carefully with the patient with pacemaker.

Table 1：Guide and declaration of manufacture-electromagnetic

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 emission-Extracorporeal shock wave Device
Guide and declaration of manufacturer-electromagnetic emission
Extracorporeal shock wave Device should work in the electromagnetic ambient specified
below.The client and user should ensure it is used in this electromagnetic ambient
conform
Emission test electromagnetic ambient--guide
ity
Extracorporeal shock wave Device is only uses RF energy
for its internal functions.Therefore,the emission of radion
frequency is low. The possibility of producing
RF emission interference with nearby electronic equipment is low.
Group 1
GB 4824

Extracorporeal shock wave Device is suitable for use in

non-residential buildings and structures directly connected
RF emission GB 4824 Class A to the public power mains with low voltage that powers
buildings intended for domestic use.

Not
Harmonic emission
applicab
GB 17625.1
le
Emission of voltage Not
fluctuations/flickering applicab
GB 17625.2 le

Table 2：Guide and declaration of manufacture - electromagnetic

immunity - Extracorporeal shock wave Device
Guide and declaration of manufacture - electromagnetic immunity
Extracorporeal shock wave Device should work in the electromagnetic ambient specified
below.The client and user should ensure it is used in this electromagnetic ambient:
electromagnetic
Immunity test IEC 60601 test level Conformity level
ambient——Guide
The floor must be made
of wood,concrete or
Electrostatic ceramic tiles. If the floor
±6 kV Contact discharge ±6 kV Contact discharge
discharge is covered in
±8 kV Air discharge ±8 kV Air discharge
GB/T 17626.2 synthetic,relative
humidity should be at
least equal to 30%
Electrical fast ±2 kV for the power ±2 kV for the power The quality of power
transient burst supply lines supply lines supply should be the

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 GB/T 17626.4 ±1 kV for the typical commercial or
input/output lines Not applicable hospital environment.
The quality of net power
Surge ±1 kV Line to line ±1 kV Line to line supply should be that a
GB/T 17626.5 ±2 kV Line to ground ±2 kV Line to ground typical commercial or
hospital environment
＜5%UT,（＞95%,dip in The quality of net power
＜5%UT,（＞95%,dip in
UT，）for 0.5 cycle； UT， supply should be that a
）for 0.5 cycle；
typical commercial or
Voltage dips,
40%UT，(60% dip inUT） 40%UT，(60% dip inUT） hospital environment. If
short power cuts
for 5 cycles for 5 cycles user requires continuous
and
operation during power
variations in
70%UT ，（ 30% dip in 70%UT ，（ 30% dip in cuts, you are
voltage on the
UT ）for 25cycles UT ）for 25cycles recommended to power
input lines of the
Extracorporeal shock
power supply
wave Device with UPS
GB/T 17626.11
＜5%UT, ＜5%UT, unite or battery.
（＞95% dip in UT ）for （＞95% dip in UT）for
5s 5s
The Power frequency
Power magnetic field should
frequency have levels characteristic
magnetic field 3 A/m 3 A/m with a typical premises in
（50Hz/60Hz） a
GB/T 17626.8 commercial or hospital
environment.
Note：UT refers to the application of AC net voltage before test voltage.

Table3：Guide and declaration of manufacture - electromagnetic

immunity - Extracorporeal shock wave Device
Guide and declaration of manufacture - electromagnetic immunity
Extracorporeal shock wave Device should work in the electromagnetic ambient specified below. The client
and user should ensure it is used in this electromagnetic ambient:
conformity
Immunity test IEC 60601 test level Electromagnetic ambient——Guide
level

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 Portable and mobile RF communication devices
should not be used near any part of extracorporeal
shock wave Device including cable, except when
they comply with the recommended separation
distances, calculated with the equation applicable to
RF Conducted 3 V（effective value） [ 3] V the transmitter frequency:
GB/T 17626.6 150 kHz～80 MHz （effective
value） d = [3.5/V1] P
RF Radiated 3 V/m
GB/T 17626.3 80 MHz～2.5 GHz [ 3 ] V/m d = [3.5/E1] P 80 MHz～800 MHz

d = [7/E1] P 800 MHz～2.5 GHz

In this equation：
where P is the maximum rated output power of the
transmitter, in watt (W), according to the
manufacturer of the transmitter, and d is the
recommended separation distance, in metres (m).
The field intensities of the fixed RF transmitters,
determined by an electromagnetic survey on site a,
should be lower than the level of conformity for each
frequency interval.b
Interference can occur near the equipment marked
with this symbol:

Note1：At the 80 MHz and 800 MHz, higher freauency equation is adopted.
Note2 ： These guidelines may not apply to all suitations. Electromagnetic propagation is influenced by
absorption and reflection of the structures, objects and people.
a. The field intensities for fixed transmitters , such as wireless(cell/cordless) phone and base station of
terrestrial radio-based ,amateur radio,AM and FM radio and television broadcasts can not be theoretically
precisely planned. To assess an electromagnetic ambient caused by fixed RF transmitters,an electromagnetic
survey should be considered onsite. If filed intesity measured onsite is used exceeds the conformity level
applicable as above the appratus should be under observation to verify whether it can work normally or not.If
irregular performance is noted, additional measures may be necessary, such as different orientation or position of
appratus.
b.The field intesity of frequency intervals from 150 kHz ~ 80 MHz should be less than [ 3 ] V/m.

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 Table 4：Guide and declaration of manufacture - electromagnetic
immunity - Extracorporeal shock wave Device
Separation distances recommended between the portable and mobile radio-communication devices and
shockwave therapy appratus
Extracorporeal shock wave Device is planned to work in an electromagnetic environment where RF
radiated disturbances are under control. The client or user can contribute to preventing electromagnetic
interferences by ensuring a minimum distance between the RF mobile and portable communication
devices (transmitters) and appratus, as recommended below, in relation to the maximum output power of
the radio-communication devices.
Separation distance of transmitter frequency
/m
Maximum rated output power
of the transmitter
150 kHz～80 MHz 80 MHz～800 MHz 800 MHz～2.5 GHz
W
d = [3.5/V1] P d = [3.5/E1] P d = [7/E1] P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For the transmitters specified for a maximum output power not outlined above, the recommended separation
distance d, in metres (m), can be calculated using the equation applicable to transmitter frequency, where P
is the maximum rated output power in watt (W) according to the manufacturer of the transmitter.

Note1：To 80 MHz and 800 MHz, the separation distance is applied for the higher frequency interval.
Note2： These guidelines may not apply to all situations. Electromagnetic propagation is influenced by
absorption and reflection of the structures, objects and people.

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