Gymna ShockMaster 500 User manual

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USER MANUAL
ShockMaster 500 & ShockMaster 300
0344

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Your specialist dealer:
Copyright GymnaUniphy NV.
ShockMaster is a registered trademark of GymnaUniphy.
Unauthorised reproduction, either in whole or part, of the software provided with this product is
strictly prohibited and is subject to prosecution.
All rights reserved.
Manufacturer:
GymnaUniphy N.V.
Pasweg 6A
3740 Bilzen
Belgium
T +32 (0) 89 510.532
[email protected]
www.gymna.com

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Table of Contents
1General Information............................................................................................. 7
1.1 Introduction........................................................................................................ 7
1.2 Device description ............................................................................................... 8
Intended use ................................................................................................. 9
Intended patient ............................................................................................ 9
Intended environment .................................................................................... 9
Contra indications .......................................................................................... 9
Side effects ..................................................................................................10
Combination with other products, interactions ..................................................10
1.3 Prerequisites for operating the ShockMaster ..........................................................10
Operator ......................................................................................................10
Training of the operator .................................................................................11
1.4 Description of controls and functional elements ShockMaster 500 .............................12
1.5 Description of controls and functional elements ShockMaster 300 .............................14
2General safety information................................................................................. 16
3Installation......................................................................................................... 20
3.1 Unpacking .........................................................................................................20
3.2 Scope of delivery................................................................................................20
ShockMaster 500 ..........................................................................................20
ShockMaster 300 ..........................................................................................21
3.3 Electrostatic discharge protective measures ...........................................................21
3.4 Device Installation ..............................................................................................22
Compressor Installation ShockMaster 500 ........................................................22
Connections at the rear of the control unit: ......................................................26
3.4.2.1 ShockMaster 500 .......................................................................................26
3.4.2.2 ShockMaster 300 .......................................................................................27
Handpiece connection ....................................................................................27
4Operation ........................................................................................................... 30
4.1 Functional check.................................................................................................30
4.2 Start-up ............................................................................................................30
4.3 Standard settings ...............................................................................................30
4.4 Treatment .........................................................................................................31
5The user interface .............................................................................................. 33
5.1 Introduction.......................................................................................................33
5.2 Home Screen .....................................................................................................34

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5.3 Treatment menu ................................................................................................35
Parameters...................................................................................................36
5.3.1.1 Pressure ...................................................................................................36
5.3.1.2 Total amount of shocks ...............................................................................36
5.3.1.3 Frequency .................................................................................................37
5.3.1.4 Actual number of shocks .............................................................................37
Behaviour of the hand piece control: ...............................................................37
Parameter increase/decrease behaviour:..........................................................37
5.4 Applications Menu...............................................................................................38
Library.........................................................................................................38
5.4.1.1 New application (NOT available for ShockMaster 300).....................................39
5.4.1.2 Load application.........................................................................................40
5.4.1.3 Application Info..........................................................................................43
5.4.1.4 Edit application (NOT available on ShockMaster 300) ......................................44
5.4.1.5 Delete application (NOT available on ShockMaster 300) ..................................44
5.4.1.6 Application Archive (NOT available on ShockMaster 300).................................44
5.4.1.7 Filter applications list ..................................................................................44
5.4.1.8 Search Application......................................................................................45
Body area menu............................................................................................45
Patients menu (NOT available for ShockMaster 300) ..........................................46
5.4.3.1 New/Edit Patient ........................................................................................46
5.4.3.2 Patient Info ...............................................................................................47
5.4.3.3 Load Patient ..............................................................................................50
5.4.3.4 Delete Patient ............................................................................................53
5.4.3.5 Search Patient ...........................................................................................53
5.4.3.6 Patient Archive ..........................................................................................54
5.5 System Buttons..................................................................................................54
Help & Info Menu ..........................................................................................54
Settings menu ..............................................................................................54
5.5.2.1 Info..........................................................................................................55
5.5.2.2 Service information ....................................................................................55
5.5.2.3 Language ..................................................................................................55
5.5.2.4 Time.........................................................................................................56
5.5.2.5 Handpiece counter (Only 1 handpiece counter available for ShockMaster 300) ...56
5.5.2.6 Patient database (NOT available on ShockMaster 300) ....................................58
5.5.2.7 Custom library data....................................................................................59
5.5.2.8 Soft Start ..................................................................................................59
5.5.2.9 Dynamic protocol (pGTS) ............................................................................59
Software update ...........................................................................................60
6Cleaning, Maintenance, Disposal, Repair ............................................................ 61
6.1 Cleaning............................................................................................................61
Cleaning the ShockMaster main unit and ShockMaster 500 trolley .......................61

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Cleaning the ShockMaster touch screen ...........................................................62
6.2 General Maintenance ..........................................................................................62
6.3 Maintenance ShockMaster500 ..............................................................................63
Emptying the bottle with condensation water....................................................64
Checking the oil level of the compressor ..........................................................64
Replacement mains fuse ................................................................................65
6.4 Decommissioning and Disposal.............................................................................66
6.5 Repair...............................................................................................................66
6.6 Expected service life ...........................................................................................66
7Status messages and trouble shooting ............................................................... 67
7.1 Status messages ................................................................................................67
7.2 Trouble shooting ................................................................................................67
8Accessories and spare parts ............................................................................... 72
8.1 ShockMaster 500................................................................................................72
8.2 ShockMaster 300................................................................................................72
8.3 Accessories........................................................................................................73
8.4 Coupling Gel ......................................................................................................73
8.5 Documentation...................................................................................................74
9Technical specifications...................................................................................... 75
9.1 Technical data of ShockMaster 500 .......................................................................75
9.2 Technical data of ShockMaster 300 .......................................................................76
9.3 Conformity with directives ...................................................................................77
9.4 Conformity with standards...................................................................................77
9.5 EMC guidance and manufacturer’s declaration........................................................78
10 Warranty and service ......................................................................................... 83
10.1 Warranty...........................................................................................................83
10.2 Service..............................................................................................................83
Attachment............................................................................................................... 84

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1General Information
1.1 Introduction
This manual contains warnings, safety instructions and specific operating instructions in
accordance with liability regulations.
CAUTION
Complete or partial failure to observe the instructions, information or procedures
preceded by the term “CAUTION” may cause injury or fatal accidents.
ATTENTION
Complete or partial failure to observe the instructions, information or procedures
preceded by the term “ATTENTION” may cause equipment damage.
NOTE
Additional information concerning specific features or operating instructions is preceded by the
term “NOTE”.

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CAUTION
Before you start using the ShockMaster for the first time, please make sure you have
read and understood all information provided in this user manual and accessory
manual(s) of detachable component(s).
Familiarity with the information and instructions contained in this manual is an
essential requirement to ensure efficient and optimal use of the device, to avoid
dangers to persons and to the equipment and to obtain good treatment results.
Thorough knowledge of the information included in this manual will enable you to
react promptly and effectively in case of malfunctions and failures.
Please also refer to the separate accessory manuals of these detachable components.
Knowledge of the content of this manual is an essential prerequisite for operating the
entire device.
NOTE
The ShockMaster may only be used with the intended components and accessories, i.e. the
RSW handpiece short and V-actor handpiece as well as the compressor and trolley for the
ShokcMaster500 model.
1.2 Device description
The ShockMaster is a compressed air operated ballistic shockwave generator featuring high-
precision ballistic components in its applicator for shockwave generation. The motion and weight
of the projectile accelerated by compressed air produce kinetic energy that is converted into
sound energy when the projectile strikes an immovable surface (shock transmitter). This
acoustic pulse is transmitted to the target tissue directly as well as by means of an acoustic
impedance adapter (shockwave coupling cushion) or gel. These waves are physically classified
as radial pressure waves. The applied pressure pulse propagates radial within the tissue and has
a therapeutic effect on areas of the tissue near the surface, in particular.
NOTE
Medical devices operating on the basis of the above principle are generally referred to as
extracorporeal shockwave devices in modern medical literature.

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Intended use
The ShockMaster is designed for extracorporeal treatment by means of low- to medium-energy
radial shockwaves in the following fields of application:
Biomechanical therapy
Myofascial trigger points (MTrP)
Disorder of tendon insertions
Activation of muscle and connective tissue
Acupuncture shockwave therapy
Intended patient
The intended patients to be treated are patients, between 18 and 65 years, suffering from
neurological and/or musculoskeletal conditions and skin lesions, on anatomical locations as
defined in the application list.
Intended environment
The foreseen environments are hospitals excluding operating rooms and emergency rooms,
clinics, surgeries in residential areas and treatment rooms in sports facilities.
Contra indications
CAUTION
The contra-indications listed here are examples. No claims are made regarding the
completeness or unlimited validity of this list of contra-indications.
Treatment with the ShockMaster is not permitted in the following cases:
coagulation disorders (haemophilia)
use of anticoagulants, especially Marcumar
thrombosis
tumour diseases, carcinoma patients
pregnancy
polyneuropathy in case of diabetes mellitus
acute inflammations / pus focus in the target area
open epiphyseal discs
cortisone therapy up to 6 weeks before first treatment
patient with a pace maker
prosthesis
osteoporosis
infected wounds
large nerves and vessel cavities that contain air (lung, intestines, …)
risk of haemorrhaging
cardiac region

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open scar
vertebrae, spinal column or head
Side effects
Treatment with the ShockMaster may cause the following side effects:
swelling, reddening, haematomas
petechiae, pain, irritation of the periosteum
skin lesions after previous cortisone therapy
cardiac arrhythmias
These side effects generally disappear after 5 to 10 days.
Combination with other products, interactions
The applied parts of the ShockMaster (handpieces with all applicators, except fascia applicators
and V-ACTOR II) are intended to be used solely in combination with a coupling gel. A sufficient
portion of gel has to be applied to ensure a proper coupling of shockwaves and to avoid side
effects with the skin of the patient in the context of applying the accessories.
ATTENTION
The coupling gel must be CE marked as medical device, separately conformity
assessed.
The coupling gel must be stored used and disposed of according to the
information supplied by the manufacturer of the product.
CAUTION
Prior to every new treatment with the ShockMaster, the user must ask the patient
for possible contra-indications or allergy to any ingredient of the coupling gel.
Furthermore, the user must educate the patient regarding the actions, side
effects and possible residual hazards related to the treatment.
1.3 Prerequisites for operating the ShockMaster
Operator
The ShockMaster is intended exclusively for use by (para)medical specialists or physiotherapists
and is only allowed to be used by qualified and trained medical persons. Such a specialist is
expected to have practical knowledge of medical procedures and applications as well as of the
technology and should be experienced in treating the applications stated in chapter Error!

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Reference source not found.. The specialist must have the basic cognitive prerequisites such
as vision, hearing and reading as well as the basic physical prerequisites like the basic functioning
of the upper extremities.
Qualified training in acupuncture and acupuncture shockwave therapy (AcuST) is required for
therapeutic application of the ShockMaster in the field of acupuncture.
A sound knowledge of trigger point therapy and trigger point shockwave therapy (TrST) is
required for therapeutic application of the ShockMaster in the field of trigger point shockwave
therapy.
Training of the operator
Operators of the ShockMaster must have been adequately trained in using this device safely and
efficiently before they operate the device described. An introduction to the principles of operation
is provided by the GymnaUniphy dealer with reference to the user manual. The operator must
be instructed in the items listed below:
Correct use of the device, with practical exercises.
Functioning of the device, including the applied energy and the effect it has on the patient.
Settings of all components
Applications this device can be used for.
Contra-indications and side effects
Explanation of all warnings described in this document
Instruction in how to perform the functional checks.
Further training requirements vary from country to country. It is the operator’s responsibility to
ensure that the training meets the requirements of all applicable local laws and regulations.
However, you can also contact the following address directly:
GymnaUniphy nv
Pasweg 6A
3740 Bilzen
Belgium
Tel.: [phone]
[email protected]

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1.4 Description of controls and functional elements
ShockMaster 500
1. LCD TFT touch screen
2. RSW handpiece
1. Connector RSW/V-actor handpiece channel black
2. Connector RSW/V-actor handpiece channel yellow
1
2
1
2

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1. USB connector (type A)
2. Compressed air inlet
3. Auxiliary power outlet for the compressor
4. Mains supply inlet
5. Mains fuses holder
6. Mains switch
7. Sign “Consult and observe the instructions for use”
NOTE
The USB connection is only suitable for connecting a USB memory stick that supports the
USB V1.1 protocol.
Use only for service purposes!
An external compressor supplies the compressed air.
1
6
4
2
5
7
3

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1.5 Description of controls and functional elements
ShockMaster 300
1. LCD TFT Touch Screen
2. Connector RSW/V-actor handpiece
3. V-actor ii
1
2
3

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1. USB connector (Type A)
2. Pressure filter housing
3. Read the manual first
4. Mains power inlet
5. Mains fuse holder
6. Mains switch
NOTE
The USB connection is only suitable for connecting a USB memory stick that supports
the USB V1.1 protocol.
Use only for service purposes!
An integrated compressor supplies the compressed air.
1
2
3
4
5
6

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2General safety information
CAUTION
The ShockMaster is exclusively intended for use by medical specialists and
must only be used by suitably qualified and trained medical personnel (see
also section 1.3 Prerequisites for operating the ShockMaster )
The user is responsible for correctly positioning the handpiece of the
ShockMaster and determining where the treatment zone of the patient is
located.
To avoid safety hazards, it is forbidden to use the device for applications other
than those specified in section 1.2.1!
Prior to every new treatment with the ShockMaster, the operator must ask the
patient for possibly existing contra-indications as well as allergic reaction of
patient to the coupling gel or any ingredient of the product. Furthermore, the
user must educate the patient with regard to the action (intensity and duration
of shockwave treatment) as well as possible side effects and possible residual
hazards in the context of the treatment.
To avoid the risk of electric shocks the device must only be connected to an
outlet socket with a protective earth terminal. The supply mains must meet
the requirements for protection class I.
Separation from the supply mains is achieved by pulling either the plug from
the outlet socket or the plug from the mains entry socket of the device.
The device must be positioned and connected to the supply mains in such a
way that this separation can be easily accomplished.
Do not use the ShockMaster in potentially explosive environments, i.e. in the
presence of a flammable anaesthetic mixture with air or with oxygen or nitrous
oxide.
Cleaning and disinfecting agents may generate an explosive atmosphere.
Disconnect the unit and accessories from the mains before starting any
cleaning and maintenance work!
Do not open the device. Risk of electric shocks!

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ATTENTION
Check the supporting surface has sufficient carrying capacity to avoid
equipment damage!
Medical electrical devices are subject to special regulations regarding
electromagnetic compatibility (EMC). Hence, medical electrical devices must
be installed and commissioned in accordance with the EMC guidelines detailed
in section 9.5 EMC guidance and manufacturer’s declaration
Portable and mobile HF communications equipment such as cell phones may
cause interferences with medical electric devices.
The use of accessories or cabling not authorized by the manufacturer may
cause increased emissions or may lead to reduced interference immunity of
the device.
The ShockMaster must not be deployed or stored together with other devices.
If it is necessary to use the ShockMaster near or together with other devices,
it must be tested against that particular environment to ensure operation
according to technical specifications.
The ShockMaster may be deployed and operated close to the listed
accessories.
Check that the device is in perfect working order before each use. A regular
maintenance is recommended.
Never cover the device when in use! Especially the ventilation slots of the
trolley (ShockMaster 500) need to be kept free.
Make absolutely sure that no liquid can seep into the device housing or
handpiece. Any damage to the unit resulting from incorrect operation is not
covered by the manufacturer’s warranty.
Disposal of the device and its components must be carried out in accordance
with national waste disposal regulations.
The ShockMaster must only be used with accessories that have been approved
by the device manufacturer. To prevent safety hazards, unauthorized device
modifications are not allowed. This will void the CE mark approval and
warranty.

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NOTE
The ShockMaster meets the requirements of the applicable electromagnetic
compatibility (EMC) standard IEC / EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference
in a typical medical installation. The equipment generates, uses and can radiate radio
frequency energy. If not installed and used in accordance with these instructions, the
equipment may cause harmful interference to other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference with other devices, (this can be established
by turning the equipment off and on), users should try to correct the interference by
means of one or more of the following measures:
 Reorient or relocate the disturbed device.
 Increase the separation between the equipment.
 Connect the equipment to an outlet on a circuit different from that to which the
other device is connected.
 Consult the manufacturer or field service technician for help.
ATTENTION
Do not plug a USB stick, other than the one specified, into the USB connector.
Do not connect the device to other equipment with a USB cable, in order to avoid
electrical safety hazards.
Do not operate the device in a no-load state and don’t apply single pulses.
Before installing / putting into service the ShockMaster , check it thoroughly for
transport damage. Do not use a damaged device, component or accessory. All
components of the device must be visually inspected.
The ShockMaster is not designed or intended for operation in damp rooms or in
potentially explosive areas or rooms with oxygen enrichment and flammable
anaesthetics (AP / APG environment).
The environmental conditions regarding storing and operating the device shall be
complied with.
While the ShockMaster is operating, the operator must not come into contact
with the patient and the device at the same time.
ATTENTION
Make sure the most recent version of the ShockMaster software is installed when
connecting a new accessory (RSW handpiece short).

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ATTENTION
Before the ShockMaster can be cleaned and disinfected, the device must be
switched off and must be separated from the supply mains (see above).
The ShockMaster and accessories must be initially cleaned and disinfected prior
to entry into service as well as before each use.
While performing cleaning / disinfection work, ensure that the work environment
is properly ventilated. Use only the specified cleaning and disinfecting agents
according to the corresponding product information provided.
Prior to each and every application (change of patient), the ShockMaster, applied
parts and accessories must be carefully cleaned / disinfected in compliance with
the specified procedure and using the cleaning and disinfecting agents specified
by the manufacturer.
While cleaning / disinfecting the device and application parts, care must be taken
to ensure that no liquid penetrates the device or accessories. In the event that
the plug contacts become wet, they must be dried thoroughly prior to further
use.
Used cleaning / disinfecting agents must be disposed in compliance with the
respective instructions provided in the user instructions of these agents.

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3Installation
ATTENTION
The ShockMaster d evice shall be installed only by qualified and authorized
personnel with sufficient knowledge of the medical application and who have
been instructed accordingly in the handling of the device.
3.1 Unpacking
Remove the equipment and accessories from the packaging container. Proceed with extreme
caution
Check that all items are included in the packaging container and that they are not damaged
Contact your supplier or the manufacturer immediately if any items are missing or damaged
Retain the original packaging, if possible. It may prove useful for any later equipment
transport
3.2 Scope of delivery
ShockMaster 500
The standard scope of delivery of the ShockMaster 500 includes the following items
ShockMaster 500 (radial shockwave device, including oil compressor and design trolley)
Complete RSW handpiece short (1 metal projectile + 1 tube included)
Extra metal projectile and tube
ShockMaster revision kit short (2 projectiles and 2 tubes)
Power cord
Bottle of coupling gel 500ml + holder
Beam applicator
D-actor®20mm applicator
Deep impact®applicator
Tissue Box
Protective anti-skid mat
User manual of the ShockMaster 500 (hard copy in English, other languages available on CD)
User manual of the compressor (hard copy in English)
User manual of the RSW handpiece short (hard copy in English, other languages available on
CD)
Safety manual (hard copy in 24 languages)
Please refer to section 8 for information on accessories and spare parts.