Refine APEX MAGNUM User manual

2019
APEX MAGNUM
DUAL FUNCTIONING ACOUSTIC WAVE THERAPY SYSTEM
Revision 1
12/11/2018
User’s Guide

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TABLE OF CONTENTS
Introduction ………………………………………………………………………………………………………….………………………………..2
Safety Warning ………………………………….…………………………………………………..……………………..………….….…………3
1 General Characteristics …………………………………..……………………………………………………….……….……….……....4
1.1 Shockwave Characteristics ………….…………………..……………………………………….………….….….…….5
1.2 Biological effects of Shockwave treatments..………………………………..……………….…………….…….6
1.3 Possible side effects of shockwave treatments ………….………….…...…………..………….….…....…..6
1.5 Contra-Indications for shockwave treatments ………….…..……………..…………..………….………..….6
2 Parts Introduction …………..………………………………………..………………….……………………………………...….…….....7
2.1 Accessories List ……….………………………….………….………………………………………………….……..…..….7
2 .1.1 Parts Inventory List.…………………………………………………………………………………………………8
2.2 Accessories Installation ……………………………….……………………….………………………..………..…….…9
2.3 Pneumatic Accessories ……………………………….…………….…………..………………………………….......10
2.4 Electromagnetic Accessories …..….…………….….………………………………………………………………….10
2.5 Replacement Parts ………………………………….………………………….…………….……………………………..11
2.6 Pneumatic Transmitter Adapter Replacement.……………………..…………….…..……….……………….12
2.6.1 Pneumatic Piston Replacement……………………………………………………………………………….12
2.7 Electromagnetic Adapter Replacement ……………………………..……..……….……..…….………….…....13
2.7.1 Electromagnetic Transmitter Screw Adjustment………….…………………………………………13
3 System Operations …………………….……………………………………….………………………….………….…..………….….…..13
3.1 Pneumatic Shockwave Control Panel.…..……………….….…………………..……………..……………....…..14
3.2 Electromagnetic Shockwave Control Panel …………….……………..……….…..…………………..…….…..16
3.3 Touchscreen Calibration …………………….………………………………………….……….……………...……….…17
3.4 Troubleshooting Tips …………………..……..………………………………………….…….…………..………….…...18
4 Maintenance and Safety …………….………….…..……………………………………………………….…..….……………......…..19
5 General Safety ..…………………..…..…..…………….…………………………………………….…………….…..……..………….....20
5.1 Protective Sheaths …………………………………..…………………………………………………………………………22
6 Technical Parameters ………………..…………………………..………………………………….…………..…………...………......22
8 Warranty ..…….…………………..….….…………………..…………..……………………………………….…….…………………....…23

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User:
Thank you for choosing the APEX MAGNUM dual functioning acoustic wave therapy system.
The Apex Magnum dual functioning acoustic wave therapy system is a high precision device.
Please follow the instructions in order to operate the machine correctly.
Please do not remove or interchange any accessories on the APEX machine.
Only authorize Refine, USA® service representative should open and remove the mainframe.
Do not make changes to the machine.
Only authorized Refine, USA® service representatives should provide maintenance to the
device.
DO NOT USE GEL OR LOTION WITH THIS DEVICE. Only use BABY OIL, IF DESIRED. The use of gels
or lotions render both hand pieces inoperable. The damage from the use of gels or lotions is not
covered under the warranty.
Contact Refine, USA® at 866-590-5533, if there is any issue with your equipment.
The following information is provided for the correct utilization of the APEX Magnum radial
shockwave therapy system. The information includes instruction on the maintenance and operation
of the device.
The safety regulations can be grouped under 2 categories:
1. Electric safety regulation
2. Electromagnetic radiation safety regulation
The EMC performance of this system has been evaluated and is in compliance with EN 60601-1-2.
Use this system in an environment free of strong electromagnetic field

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WARNING
Safety note:
READ THIS MANUAL TO LEARN ALL SAFETY REQUIRMENTS AND OPERATING
PROCEDURES, BEFORE ATTEMPTING TO OPERATE THE SYSTEM.
•High voltage components are contained inside the system.
•Set proper parameters before applying treatment.
•Do NOT open the back panel.
USER’S INSPECTION
DAMAGE CAUSED IN TRANSIT
The unit and all accessories must be checked for potential defects, transport damage, or loss
immediately after receipt.
Specifications are subject to change without notice.
WARNING
Note the unit has not been designed for use in potentially explosive atmospheres. Please treat
equipment gently. Always ensure that any cleansing, degreasing or disinfecting agents applied have
evaporated completely before using the unit.

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1. GENERAL CHARACTERISTICS
The APEX Magnum is a state-of-the-art device allowing the application of therapy using non-invasive
shockwaves. Shockwaves are one of the most effective ways to treat pain associated with the
musculoskeletal system. Musculoskeletal pain is currently the second-leading cause of absences in the
workplace.
The device is equipped with a color touch screen on the main unit for simplified use. The on-screen
information will guide the user, step-by-step, through each entire therapy process. The therapeutic
parameters are easily set using the touch screen buttons.
Begin therapy by selecting a treatment protocol or a therapy program. The treatment parameters can
be manually with the easy-to-use touch screen buttons. Throughout the course of a therapy session, the
device will keep the user informed about the therapeutic method in use, the type of treatment, the total
number of shocks to be applied, the frequency being used, the intensity, and other necessary data.
The APEX Magnum system has predefined programs stored in the memory of the main unit, a great
time-saving feature. Based on detailed research and practical use of the device, the well-organized
predefined programs will provide recommendations for the treatment of various conditions.
The device consists of three parts: the main unit and the two applicators.
Main Unit: APEX system which contains the main microcomputer and operating software. Also
includes user encyclopedia and the therapy guide.
Pneumatic hand piece
Electromagnetic hand piece
* Both hand pieces average 2 million pulses prior to replacement. It is recommended to
replace each hand piece after 2 million pulses
1.1 SHOCKWAVE AND ITS CHARACTERISTICS
A shockwave is defined as a wave with a rapid increase of pressure within a very short time and then
having a gradual decrease of pressure with a small negative pressure phase. Shockwaves are aimed at
the affected areas that are the source of chronic pain. The influence of the shockwaves causes the
dissolution of calcium deposits and leads to better vascularization. The after-effect is relief from the
pain.
Outside of the client's body (extracorporeal), a pressure pulse of high amplitude is generated and its’
energy is concentrated on the target area. The pressure pulse travels through a liquid medium gel into
the client’s body and penetrates soft tissue without major energy loss.

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The pressure course of the shockwave in real-time is expressively different from the pressure course of
the harmonic sound wave. Shockwaves can be compared to ultrasonic waves; which are characterized
by a pressure jump change, a higher amplitude, and non-periodicity.
In the shockwave, the positive amplitude is generally much larger than the negative amplitude. The
frequency rate of the shockwaves is usually low (in Hz units) and the eventual cavitation (the
disturbance of material consistency and the development of cavities) will relax. Consequently, there is
no threat of energy absorption in the cavitation, as is the case with continuous ultrasound.
A substantial part of the shockwave energy penetrates into the liquid (of the organism) with a great
positive pressure pulse. Its diffusion is only limited by the actual tissue absorption and eventual
reflections on acoustic non-homogeneities.
A shockwave is defined as a pressure pulse with these characteristics:
High positive pressure amplitude: 10 to 1000 MPa = 100 to 1000 Bar (100x atmospheric
pressure)
Low negative pressure amplitude: 1 to 10 MPa
Short time duration: 1 mu to 20 mu
Rapid pressure increase: < 100 ns
Broad frequency spectrum: 1 Hz to 1 MHz
For therapeutic applications, these values are lower, especially the maximum pressure amplitude. The
maximum pressure amplitude is about 15 MPa, the pulse length is 10 to 20 mu, and the frequency of the
applied shockwave is 1 to 21Hz. The treatment is generally carried out without local anesthesia and lasts
about 15 to 30 minutes. During the first week after treatment, the client should avoid all physical
activities that could excessively strain the treated area.
Several types of generators have been developed for shockwave therapy, each producing shockwaves
with varied characteristics. Each type of generation method produces shockwaves with different time
progressions and spatial arrangements.
The APEX Magnum system provides both the pneumatic and electromagnetic principles of shockwave
generation.
A pressure wave is formed via a projectile. Using elastic impact, the kinetic energy of the projectile is
transferred into the probe of the applicator and then into the client's body. Consequently, during the
treatment, the end of the sheath covered applicator must be in direct-contact with the skin and
subcutaneous tissue.

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1.2 BIOLOGICAL EFFECTS OF SHOCKWAVE TREATMENT
The effects of the shockwaves mainly occur at sites where there is a change in impedance, such as the
bone/soft tissue interface.
Analgesic effect:
Destruction of afferent nerves and nerve receptors.
CNS stimulants, sensed as pain, are also inflammation transmitter substances.
Regression of pain caused by local ischemia.
Gate control theory of pain
1.3 POSSIBLE SIDE EFFECTS OF SHOCKWAVE TREATMENT
Erythema or swelling can temporarily occur in the treated area.
Loss of bodily sensation or itching can temporarily occur in the treated area.
Hematoma(s)
Petechia
Skin damage after previous corticoid therapy.
Shockwave application can cause undesirable heart activity.
1.4 INTENDED USE FOR SHOCKWAVE TREATMENT
ESWT is for the intended use as a treatment for musculoskeletal pain.
1.5 CONTRAINDICATIONS FOR SHOCKWAVE TREATMENT
Application to certain tissues: The eyes and the surrounding area, the myocardium, the spinal
cord, the gonads, the kidneys, and the liver are not to be treated.
Blood disorders, coagulation problems, or the use of anticoagulants
Blood thinning medications (Warfarinization)
Polypus in the area of treatment
Pregnancy
Thrombosis
Tumor diseases
Polyneuropathy
Acute inflammation
Growing cartilage in children
Therapy using corticoids
Inapplicable on areas of the body and organs with possible gas content
Inapplicable on areas in proximity to large nerve bundles, blood vessels, the spinal cord and the
head

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2. PARTS INTRODUCTION
1. Touch Screen
2. Electromagnetic handle accessory frame
3. Pneumatic handle accessory frame
4. Plug for Pneumatic wave handle
5. Cooling Fan
6. Power Switch
7. Power Plug
8. Filter cup with pressure gauge
9. Plug for pedal switch
10. Plug for Electromagnetic wave handle
2.1 ACCESSORIES LIST
Device 1pc
A-shock wave handle 2pcs
E-Shock wave handle 2pcs
A-handle transmitters 11pcs
E-Handle transmitters 5pcs
Accessories frame 2pcs
Foot Switch 1pc
Silicone Caps 10 pcs
Protective Sheaths 10pcs
Allen Wrench 2pcs
Replacement Pistons 3pcs
1.
2.
3.
4.
5.
6. 7.
8.
9.
10.

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2.1.1 Parts Inventory List
Item Description Quantity
Pneumatic Handle Pneumatic hand piece 2
Electromagnetic Handle Shockwave hand piece 2
Pneumatic Transmitter Adapters Pneumatic transmitter adapter
treatment heads
11
Electromagnetic Transmitter
Adapters
Electromagnetic transmitter
adapter treatment heads
5
Foot Pedal
Foot pedal for power 1
Apex Silicone Caps Blue covers 10
Apex Protective Sheaths Latex covers 10
Allen Wrench L-shaped tool 2
Power Cord Black cord 1
Replacement Pistons ½ ‘ metal thread piston 3

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2.2 ACCESSORIES INSTALLATION
Inspect the box for damage and report any to the transport carrier and the distributor. Do not proceed
with assembly and set-up if the box is damaged. Keep the original box and packaging to ensure safe
future transport of the device. When bringing the device from a cold environment into a warm one, do
not plug it into the power source until the device has had time to equilibrate to room temperature
(Minimum 2 hours).
Unpack the device and place it on a stable horizontal surface. Always position the device out of direct
sunlight. Please note, the control unit heats when in use. The device must not be positioned near other
heat sources. Allow a minimum of 4 inches (10cm) clearance behind the rear panel. Do not place the
device on any soft surface (such as a towel), which may obstruct air flow to the bottom cooling vents. Do
not put any heat-producing devices or any objects containing water or other liquids on the device. Do
not place the device close to appliances producing strong electromagnetic, electrical or magnetic fields
(diathermy, X-rays, etc.), this could damage the device and negatively affect the appliance.
Procedure:
1. Install all components. Plug the applicators into the back panel sockets.
2. Connect the device to the supplied power adapter. Plug the device directly into the socket by aligning
the red dots. Do not use any multi-connection extension cables or two-socket adaptors.
3. Connect the applicators to the connector on the back panel as follows:
Turn the applicator so that the red dot is in line with the red dot on the output connector. Plug the
connector in. When disconnecting the connector, take the indented part of the applicator connector and
pull slowly towards you, to disconnect carefully.
CAUTION
DO NOT USE FORCE TO CONNECT, IF FORCE IS APPLIED THERE IS A RISK OF DAMAGE TO THE DEVICE.

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2.3 Pneumatic Accessories
Pneumatic-shockwave handle
A 6 mm A 10 mm A15 mm A20 mm A25 mm
Flat Pneumatic Transmitter Adapters
B 15 mm B 20 mm B25 mm
Convexed Pneumatic Transmitter Adapters
C 15 mm C 20 mm C25 mm
Concaved Pneumatic Transmitter Adapters
2.4 Electromagnetic Accessories
Electromagnetic-Shockwave handle
#3=10 mm #6=15mm #4=15mm #7= 20mm #5= 39mm
Transmitter adapters are designed
flat, convexed, and concaved.

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2.5 Replacement Parts
Item Photo Description
Pneumatic Handle Pneumatic hand piece
Electromagnetic Handle Shockwave hand piece
Electromagnetic Transmitter
Adapters
Shockwave handle tips
Foot Pedal
Foot pedal for power
Pneumatic Transmitter
Adapters
Pneumatic handle tips

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2.6 Pneumatic Transmitter Adapter Replacement
Only one transmitter can be installed on the applicator at a time. To exchange the transmitter: stop and
power off the machine. Check the treatment protocols to choose the proper transmitter. Secure the
transmitter on the applicator prior to treatment
#1 Transmitter Adapter Screw Cap After Installation
2.6.1 Pneumatic Transmitter Piston Replacement
Assembled Handpiece Unscrew to remove transmitter Unscrew to remove tube
Piston placement Slide piston out of tube Insert piston into tube
Screw tube into handpiece Screw transmitter onto tube Reassemble handpiece

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2.7 Electromagnetic Adapter Replacement
Only one transmitter can be installed on the applicator at a time. To exchange the transmitter stop and
power off the machine. Check the treatment protocols to choose the proper transmitter. Secure the
transmitter on the applicator prior to treatment.
Unscrew adapter by twisting counter clockwise until
removed from handpiece.
Screw chosen adapter head in securely, until flush with
handpiece.
2.7.1 Electromagnetic Screw Adjustment
Ensure the screws on the electromagnetic handpiece are
tightened regularly between uses to provide optimal
treatments.

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3. SYSTEM OPERATIONS
3.1 Pneumatic-Shockwave Control Panel Description
In interface as (FIG 1)
Input default password: “888888”
In interface as (FIG 2)
Click on “Basic setting” to select language, set
time
Notice: “ADVANCED SETTING” is only for
Engineering debugging. DO NOT USE.
Click “A shock” to enter Interface as (FIG 3)
(1) Click on the body part chosen for
treatment on the screen
(2) This system includes 9 different body
parts
(3) Each operation is programed with two
automatic modes, C and P mode
(4) Example treatments Instructions
FIG 1
FIG 2
FIG 3

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In interface as (FIG 3)
(1) Apply baby oil to body part to be treated.
(2) Make selection to enter the treatment screen.
(3) Install the recommended tip on the handle.
(4) Choose the mode you need, for example, select “C mode”.
(5) Click the “Start” button on the screen.
(6) Apply the hand piece to the treatment area; choose the “Start” button on the control panel to start
working “Preload600”. This stands for when the system works to 600 impacts per treatment. It will
pause automatically.
Click on any place of the screen to restart.
(8) “Impact” represents the number of shocks.
(9) “Round” represents the number of rounds completed (600 impacts are one round).
(10) “Frequency 6 HZ” stands for the system default work frequency is 6 HZ, “Energy 2.0 BAR” stands for
the system default work Energy is 2.0 BAR click on "<” and “>”to adjust. The range is: 1 HZ-21 HZ or 1-6
BAR
(11) Click on the > key and the system is in standby state as in (FIG 3). Press control button on handle
once the handle begins to work. Press the control button again or Click on ‘II’, the System pauses.
(12) You may use the touch screen to set/adjust the working parameters.
C mode is comfortable mode softer, more suitable for customers with a weak tolerance.
P mode is professional mode, greater intensity based on clinical recommendations.
Both modes have parameters that have been preset, including the default intensity, frequency,
and number of impacts.

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3.2 Electromagnetic Shockwave Control Panel
Click the interface (Fig1)
To enter interface as (Fig4) △Click-SHOCK” to enter interface as (Fig 4)
Fig 1 Fig 4
1) Click on the body part on the screen to be treated.
2) ach operation is programed with two automatic modes, C mode and P mode(s).
C mode is comfortable mode, softer, suitable for customers with weak tolerance
P mode is professional mode, greater intensity, based on clinical recommendations
Both modes have parameters that have been set, including the default intensity, frequency, and number
of impacts. The automatic mode can also be adjusted freely to the most suitable parameters.
Treatment example for “Elbow adipose tissue”
In interface as Fig 4
1) Apply baby oil to the treatment area.
2) Click on “Elbow” to enter the treatment screen .
3) Install the recommended tip on to the handle.
4) Choose the mode you need, for example, select “C” mode.
5) Click the “Start” button on the screen.
6) Apply the hand piece to the treatment area, click the “Start” button on the handle control panel
to start working.
7) “Preload600” stands for when the system works to 600 impacts per treatment. It will pause
automatically. Please click on any place of the screen to restart.

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8) “Impact” represents the number of shocks.
9) “Round” represents the number of rounds completed (600 impacts are one round).
10) “Frequency 12HZ” stands for the system default work frequency is 12HZ, “Energy 100MJ” stands
for the system default, work Energy is 100MJ click on “<” and “>” to adjust. The range is: 1HZ-
16HZ or 5-200MJ.
11) “Energy 50MJ” stands for the system default work frequency is 50MJ, click on “<” and “>” to
adjust. The range is 50MJ-200HJ. When the frequency is 1Hz to 13HZ, the energy is 50-200MJ.
When the frequency is 14Hz, the energy is 50-150MJ. When the frequency is 15HZ, the energy
is 50-130MJ. When the frequency is 16HZ, the energy is 50-100MJ.
3.3 Touch Screen Calibration
1. Before powering on the device, press on the screen with your finger, do not remove your finger from
the screen and turn on the power switch.
2. The prompts “err0” on the screen, after releasing, the device enters into the calibration procedure,
operating under the prompts of the screen. Release your finger now.
3. Operating under the prompts:
Press the cross dot in the left-top “+”
Press the cross dot in right-top “+”
Press the cross dot in right-bottom “+”
Click on the point (left top)
Click on the point (right bottom)
4. Calibration screen finished, the system enters “input password” interface.
5. Do not input the password, turn off the power switch, and reboot the system.

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3.4 Troubleshooting Tips
Please attempt the following diagnostics if your device is not operating properly. If additional assistance
is required, please call our Customer Service Department.
1. Nothing happens when turning on the general power switch:
Ensure that AC power is normal
Ensure the power supply line is not broken
Ensure the fuse is normal and not blown.
2. Touch screen failure:
If the touch screen is broken, please call the Customer Service Department.
Touch screen click on invalid: Gently press the four corners and the center of the screen, then
turn off the instrument, wait for one minute, restart device.
Positioning error of touchscreen: Turn on the instrument, enter interface of calibration. If the
problem still exists, please call the Customer Service Department
Touch screen display error: Please turn the power off, wait one minute after and power on
again. If the problem still exists, please call the Customer Service Department.
3. After starting, the screen displayed:
E0: Connection failure between display control board and hand piece control board.
oPlease check if the plug of the cooling handle [8] is connected accurately. Reboot device
E1: Connection failure between display control board and function control board.
This may be due to a loose connection between display control board and function control
board. Please call the Customer Service Department.
E2: Flow sensor Fault. Check to see if water is needed. Check to see if the connection from the
device to the hand piece is being pressed or folded. If the problem still exists, add the coolant
again.
E4/E5: The temperature sensor of left/right hand piece is not working, place hand piece in hand
piece holder. If the temperature deviates on the hand piece, place the hand piece in hand piece
holder. Allow to rest for 30 minutes.
4. Any use of gel with the Electromagnetic hand piece will damage the device and cause the device to
malfunction.
5. The compressor on the back of the device may get moved out of alignment, contact the
manufacturer.
6. Stuck foot pedal, contact the manufacturer.
7. Pneumatic handpiece piston (bullet) gets stuck or needs replacement the pressure and sound on
the handpiece will decrease. ( see fig 2.6.1 )
8. Pneumatic and Electromagnetic hand pieces will malfunction if not attached properly, or loose.

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4. MAINTENANCE AND SAFTETY
A service inspection including the measuring of all parameters of the device and relevant recalibration
must be performed at intervals shorter than 30 months. The inspection and recalibration must be
performed by a service department authorized by Refine, USA®. If the inspection is not done at 30-
month intervals, the manufacturer does not guarantee the technical parameters or safe operation of the
product.
To keep the device clean, do not store or use it in extremely dusty environments. Do not immerse it in
liquid. Before each use, check that the device and its accessories (especially cables) are not mechanically
or otherwise damaged. Do not use the device if it is damaged.
Exterior cleaning of the device:
Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of
the Apex Therapy System and its parts. Never use cleaning agents containing alcohol, ammonia,
benzene, thinners, etc. Never use abrasive cleaning materials which will scratch the device's surfaces.
No parts of the device require sterilization. Care should be given to prevent water or other liquids from
getting inside the device.
Cleaning and maintenance of accessories which come into contact with the patient:
Clean and disinfect after each client, using approved cleaning agents. For example, Sekusept, Bacilol, or
Incidur Spray can be used. For the cables and accessories, use Incidur Spray. DO NOT USE SOLVENTS.
The exterior surface of the shock transmitter can be washed with warm water with its cap on. However,
to completely remove all of the contact oil from the shock transmitter, it will be necessary to unscrew
the shock transmitter and clean it.
Sklar soak or comparable cold sterilization solutions are recommended for sterilizing applicator heads.