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!