Gymna ShockMaster 300 User manual

0197
USER MANUAL
ShockMaster 300

2

3
Copyright Uniphy Elektromedizin GmbH & Co. KG, 2013.
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:
Uniphy Elektromedizin GmbH & Co KG
Neuendorfstraße 19b
D-16761 Hennigsdorf, Deutschland
Tel.: [phone]
Fax: [phone]
Worldwide distributor:
GymnaUniphy NV
Pasweg 6A
3740 Bilzen
Belgium
Tel.: [phone]
Fax: [phone]
[email protected]
www.gymna.com

4
Content
1General Information..............................................................................................6
1.1 Purpose...............................................................................................................6
1.1.1 Indications .....................................................................................................8
1.1.2 Contra-indications...........................................................................................8
1.1.3 Side effects ....................................................................................................9
1.1.4 Combination with other products.......................................................................9
1.2 Symbols..............................................................................................................9
1.3 Prerequisites for operating the ShockMaster 300 .................................................... 10
1.3.1 Operator ...................................................................................................... 10
1.3.2 Training of the operator ................................................................................. 10
1.4 Description of controls and functional elements...................................................... 11
1.4.1 ShockMaster 300 .......................................................................................... 11
1.4.2 Compressed air supply................................................................................... 12
2Installation..........................................................................................................13
2.1 Unpacking ......................................................................................................... 13
2.2 Scope of Delivery ............................................................................................... 13
2.3 Installation ........................................................................................................ 14
2.3.1 Hand piece / V-ACTOR securing installation...................................................... 14
2.3.2 Connecting the power cord............................................................................. 15
2.3.3 Hand piece connection ................................................................................... 16
2.4 Protective measures against electrostatic discharge (ESD)....................................... 17
3Operation ............................................................................................................18
3.1 General warnings and safety information............................................................... 18
3.2 Operation .......................................................................................................... 20
3.2.1 The user interface ......................................................................................... 20
3.3 Start-up............................................................................................................ 31
3.4 Functional checks ............................................................................................... 33
3.5 Standard settings ............................................................................................... 33
3.6 Treatment ......................................................................................................... 34
4Cleaning, Maintenance and Overhaul...................................................................36
4.1 Cleaning............................................................................................................ 36
4.2 Replacement mains fuse...................................................................................... 37
4.3 Replacing the filter element ................................................................................. 38
4.4 Maintenance ...................................................................................................... 40
4.5 Disposal ............................................................................................................ 40

5
4.6 Repair............................................................................................................... 41
4.7 Service life ........................................................................................................ 41
5Trouble shooting .................................................................................................42
5.1 Trouble shooting ................................................................................................ 42
6Accessories and spare parts................................................................................43
6.1 ShockMaster 300................................................................................................ 43
6.2 Accessories........................................................................................................ 43
6.3 Documentation................................................................................................... 44
7Technical Specifications ......................................................................................45
7.1 ShockMaster 300................................................................................................ 45
7.2 Identification plate ShockMaster 300..................................................................... 46
7.3 Conformity with directives ................................................................................... 46
7.4 Conformity with standards................................................................................... 46
8Warranty and service ..........................................................................................52
8.1 Warranty........................................................................................................... 52
8.1.1 Warranty for the control device....................................................................... 52
8.2 Service.............................................................................................................. 53

6
1General Information
1.1 Purpose
This manual contains warnings, safety instructions and specific operating instructions in
accordance with liability regulations.
DANGER
Refers to a situation of acute danger which, if not avoided, could lead to serious
or fatal injury
.
WARNING
Refers to a situation of potential danger which, if not avoided, could lead to serious or
fatal injury.
CAUTION
Refers to a situation of potential danger which, if not avoided, could lead to minor
injury.
ATTENTION
Warns against possibly harmful situations that could lead to damage to either the product or to the
surrounding area.
NOTE
Additional information concerning specific features or operating instructions is preceded by the
term “NOTE”.

7
CAUTION
Before you start using the ShockMaster 300 for the first time, please make sure that
you have read in full and understood all the information provided in this operating
manual.
Familiarity with the information and instructions contained in this manual is essential
for ensuring efficient and optimal use of the instrument, for avoiding hazards to
personnel and equipment and for obtaining good treatment results.
Thorough knowledge of the information included in this manual will also enable you to
react promptly and effectively in the event of malfunctions and errors.
When using optional accessories, please also refer to the separate operating manuals
for each of these accessories. It is imperative that users be familiar with the content
of this manual before operating any part of this system.
The ShockMaster 300 is a compressed air–operated ballistic shock wave generator. The shock
waves in the ShockMaster 300 are generated with a precision ballistic mechanism in the hand
piece. A projectile is accelerated by compressed air.
The motion and weight of the projectile produces kinetic energy. When the projectile impacts
against an immovable surface, the shock transmitter, this kinetic energy is converted into
sound energy, which, with the aid of a coupling gel, is transferred into the biological tissue.
This acoustic pulse is transmitted into the tissue to be treated either directly or via an acoustic
impedance adapter (shock wave coupling cushion).
Physically speaking, these are radial pressure waves. The applied pressure pulse propagates
radially within the tissue and has a therapeutic effect predominately on areas of the tissue
near the surface of the skin.
The medical device is designed for temporary therapeutic use on intact skin, and serves both
physical and biomechanical muscle therapy using pressure waves, as well as for use on
myofascial trigger points and sinew insertions. Furthermore, therapeutic activation of muscle
tissue and pressure wave acupuncture is also possible with the device
NOTE
Medical devices operating on the basis of the above principle are generally
referred to as extracorporeal shock wave systems in modern medical literature.

8
1.1.1 Indications
The ShockMaster 300 is an instrument for extracorporeal shockwave therapy. Indications
include:
•Biomechanical therapy
•Myofascial trigger points (Metro)
•Diseases of the tendon insertions
•Muscle and connective tissue activation
•Acupuncture shock wave therapy
1.1.2 Contra-indications
CAUTION
The contraindications listed here are examples. No claims are made regarding
the completeness or unlimited validity of this list of contraindications.
Treatment with the ShockMaster 300 is not permitted in the following cases:
•Coagulation disorders (haemophilia)
•Use of anticoagulants, especially Marcumar
•Thrombosis, Osteoporosis, Neuropathy (for example; as a secondary disease to
Diabetes)
•Tumour diseases, carcinoma patients
•Pregnancy
•Children in growth
•Cortisone therapy up to 6 weeks before first treatment
•Heart pacemakers, stent implants
CAUTION
Shock waves must not be applied to target areas located above air-filled
tissue (lungs) nor to any regions near large nerves, vessels (arteries or
veins), as well as near to the heart (including the sternum), the spinal
column or head (except in the facial area).

9
1.1.3 Side effects
Treatment with the ShockMaster 300 may cause the following side effects:
•Swelling, reddening, haematomas
•Petechial
•Pain, Irritation of the periosteum
•Skin lesions after previous cortisone therapy
•Cardiac arrhythmias
These side effects generally abate after 5 to 10 days.
1.1.4 Combination with other products
Therapeutic uses of the R-SW hand piece are achieved by using the coupling gel as a
conformity assessment accessory (see Chapter 6.2).
During use with the optional V-Actor accessory, massage oil can be used as an alternative to
coupling gel (for example; from the Company of W. Spitzner Arzneimittelfabrik GmbH).
1.2 Symbols
Applied part type B 2009
Year of manufacture
CE mark with registration
number of the notified body Manufacturer
SN Serial number
Do not dispose this electrical
equipment with general house
hold waste
REF Article number General warning sign
Mains fuse Read the manual!

10
1.3 Prerequisites for operating the ShockMaster 300
1.3.1 Operator
The ShockMaster 300 is intended exclusively for use by medical specialists and may only be
used by qualified and instructed medical personnel.
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 indications
stated in chapter 1.1.1.
The specialist must have the basic physical and cognitive prerequisites such as vision, hearing
and reading. Furthermore, the basic functions of the upper extremities must be guaranteed.
The instrument is designed for a demographic target group between 18 and 65 years.
1.3.2 Training of the operator
Operators of the ShockMaster 300 must have been adequately trained in using this system
safely and efficiently before they operate the instrument described in this handbook. An
introduction to the principles of operation can be provided by your dealer with reference to this
operating manual.
The operator must be instructed in the following points:
•Instruction in the operation and designated use of the instrument with practical
exercises
•Mechanism of action and function of the instrument and the energies delivered by it
•All component settings
•Indications for use of the instrument
•Contraindications and side effects of the therapy waves
•Explanation of the warning notes in all operating statuses
•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.
Further information on training in the operation of this system is available from your dealer.

11
1.4 Description of controls and functional elements
1.4.1 ShockMaster 300
1. LCD TFT Touch Screen
2. Connector R-SW/V-ACTOR hand piece
3. V-Actor
1. Connector for R-SW hand piece / V-ACTOR

12
4
5
1. USB connector (Type A)
2. Pressure filter housing
3. Mains connector
4. Mains fuse holder
5. Mains switch
6. Read the manual first
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!
1.4.2 Compressed air supply
An integrated compressor supplies the compressed air.

13
2Installation
2.1 Unpacking
•Carefully remove the instrument and accessories from the packaging container.
•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. It may prove useful for any later equipment transport.
2.2 Scope of Delivery
The standard scope of supply for the ShockMaster 300 includes the following items:
•ShockMaster 300 control device
•Mains cable (EU / USA)
•Gel bottle (conformity assessment accessory)
•User manual
•R-SW hand piece set
•Hand piece holder, complete
•V-Actor holder
Please refer to chapter 6 ACCESSORIES AND SPARE PARTS for information on optional
accessories.

14
2.3 Installation
2.3.1 Hand piece / V-ACTOR securing installation
•The R-SW hand piece can be fitted on the right side of the system as desired by the
system user
•The V-Actor holder can be fitted on the left side of the system as desired by the system
user.
•Remove the holders and associated screws from the packaging container
•Mount the hand piece holder as shown using a size PH2 cross point screwdriver.
ATTENTION
Only use the prescribed tool. The use of incorrect or faulty tools can lead to accidents and damage
to the device.

15
2.3.2 Connecting the power cord
•
Connect the supplied mains cable to the mains connection on the rear of the instrument.
•Insert the mains plug into the socket.
ATTENTION
When setting up the instrument, make sure that the air outlets on the housing of the
ShockMaster 300 is not blocked.
The instrument must only be connected to properly earthed and correctly installed shockproof
sockets.

16
2.3.3 Hand piece connection
•Connect the plug of the R-SW hand piece or V-ACTOR to the connector of the
ShockMaster 300.
•Ensure that the red dots on the connector match the red dots on the plug of the R-SW
hand piece or V-ACTOR connection.
NOTE
Please also refer to the separate operating manual for your R-SW hand piece
and V-ACTOR.

17
2.4 Protective measures against electrostatic discharge
(ESD)
The following measures must be complied with during installations:
Before creating an electrical connection, the housing of the medical product should be touched
to discharge any electrostatic.
Only use the accessories for this medical product that are listed in Chapter 6.2.
Avoid any direct contact with freely exposed plug contacts or sockets, including the accessories
of this medical product.
We recommend that all persons involved be trained with regard to the ESD protective
measures. Non-compliance can lead to faults with electronic components in the device and its
accessories through electrostatic discharge.

18
3Operation
3.1 General warnings and safety information
CAUTION
The ShockMaster 300 is intended exclusively for use by medical specialists
and may only be used by suitably qualified and trained medical personnel
(Refer to chapter 1.3 PREREQUISITES FOR OPERATING THE ShockMaster
300).
The user is responsible for correctly positioning the hand piece /V-Actor of the
ShockMaster 300.
Correct determination of the location of the treatment zone is the
responsibility of the user.
Only perform treatments for the indications given by the manufacturer,
Uniphy Elektromedizin!
To avoid safety hazards, use of the instrument for applications other than
those specified in chapter 1.1.1 INDICATIONS is not allowed!
Do not use the ShockMaster 300 in potentially explosive environments, i.e. in
the presence of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.
If instruments are connected that are not medical products as defined by
EN IEC 60601-1, they must be placed at least 1.5 m from the patient
environment, e.g. the treatment table.
Cleaning agents and disinfectants can form an explosive atmosphere.
Disconnect the ShockMaster 300 from the mains before starting any cleaning
or maintenance work!
Do not try to open the instrument! Risk of electric shocks!
Disconnect the hand piece from the instrument before carrying out cleaning
and maintenance work. Do not reconnect it until it has been completely
reassembled!
There is a risk of transmitting microorganisms when reusing the device and
accessories for its intended purpose. Clean the hand piece after each use!
Refer to chapter 4 CLEANING for details.

19
ATTENTION
Check that the installation surfaces have sufficient carrying capacity to avoid
equipment damage!
Electric medical devices are subject to special regulations regarding
electromagnetic compatibility (EMC). Hence, electric medical devices must be
installed and commissioned in accordance with the EMC guidelines detailed in
the accompanying documents.
Portable and mobile HF communications equipment (such as cell phones) may
cause interference with electric medical devices. The use of accessories or
cabling not authorised by the manufacturer may cause increased emissions or
may lead to reduced interference resistance of the device.
The ShockMaster 300 must neither be deployed nor stored together with other
devices. If the operation near or jointly with other devices is required, the
ShockMaster 300 must be tested in that particular environment to ensure
operation according to technical specification. The ShockMaster 300 may be
positioned and operated near the listed accessories.
The instrument must only be connected to properly earthed and correctly
installed shockproof sockets!
Check that the instrument is in perfect working order before each use (see
chapter 3.3 FUNCTIONAL CHECKS).
Never cover the device during use !
Make absolutely sure that no liquid can seep into the system housing or hand
piece. Any damage to the instrument resulting from incorrect operation is not
covered by the manufacturer’s warranty.
Disposal of the instrument and its components must be carried out in
accordance with national waste disposal regulations.
The ShockMaster 300 must only be used with accessories that have been
approved and declared as dedicated by the system manufacturer. To prevent
safety hazards, unauthorized system modifications are not allowed. This will
void the CE mark approval and warranty.

20
NOTE
The ShockMaster 300 meets the requirements of the applicable
electromagnetic compatibility (EMC) standards EN60601-1-2.
These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. The instrument described here
generates and uses high-frequency energy and can emit the same. If not
installed and used in accordance with these instructions, the instrument
may cau
se harmful interference with other devices in the vicinity. However,
there is no guarantee that interference will not occur in a particular
installation. If this product does cause harmful interference with other
devices, which can be determined by turning
the instrument off and on, the
user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving device.
• Increase the distance between the devices.
• Connect the devices 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.
3.2 Operation
3.2.1 The user interface
3.2.1.1 Introduction
The user interface is divided into 1 main screen (home/treatment-screen) and 5 menu screens.
When switching on the device, you automatically enter the main screen (treatment screen).
You can use the 5 control buttons at the bottom of the screen to display a menu.