Gymna ShockMaster 500 Instrucciones De Seguridad página 11

2.2 Explosion prevention
Do not use the ShockMaster in damp rooms or potentially explosive environments, i.e. in the presence of
a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
2.3 Operational safety
Nearby portable and mobile HF communications equipment such as cell phones may cause interferences.
Before you start using the ShockMaster for the first time, please make sure you have read and
understood all information provided in the user manual and accessory manuals for the detachable
components. Thorough knowledge of the information in these manuals will enable you to react promptly
and effectively in case of malfunctions and failures.
All status and error messages that appear during treatment must always be acted upon immediately.
The ShockMaster is exclusively intended for use by medical specialists and must only be used by suitably
qualified and trained medical personnel.
The user is responsible for correctly positioning the hand piece of the ShockMaster and determining
where the treatment zone of the patient is located.
Prior to every new treatment the user must ask the patient for possible contra-indications and 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.
To avoid safety hazards, the device must not be used for applications other than these:
 biomechanical therapy
 myofascial trigger points (MTrP)
 disorder of tendon insertions
 activation of muscle and connective tissue
 acupuncture shockwave therapy
The contra-indications listed below are examples. No claims are made regarding the completeness or
unlimited validity of the list.
 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 pacemaker
 prosthesis
 osteoporosis
 infected wounds
 large nerves and vessel cavities that contain air (lung, intestines, ...)
 risk of haemorrhaging
 cardiac region
 open scar
 vertebrae, spinal column or head
Side effects generally disappearing within 5 to 10 days.
 swelling, reddening, haematomas
 petechiae, pain, irritation of the periosteum
 skin lesions after previous cortisone therapy
 cardiac arrhythmias
NOTE:
The operating ambient temperature for the appliance is between +10°C and +40°C.
2.4 Medical Device Directive
The appliance meets the most recent adapted essential requirements stated in the Medical Device
Directive issued by the European Commission (93/42/EEC).
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