fitvibe medica
l
Pro
User Manual, Version 01/2004
9
1. SAFETY INFORMATION
1.1 Electrical Safety
This unit may only be used in areas and facilities which comply with the relevant applicable legal
regulations. The unit must be fitted with a shockproof (earthed) plug.
1.2 Prevention of Explosions
This unit must not be used in areas where flammable gas or vapor may be found.
1.3 User Safety
•
If you suffer or may suffer from one or more of the specified contra-indications (see:
„ Contra-
Indications“
on the main "fitvibe medical Pro" menu) you must consult a medical doctor or
physiotherapists before using the "fitvibe medical Pro" vibration unit. Section 3.1 of this manual
provides a comprehensive overview of all contra-indications.
•
Stop using the "fitvibe medical Pro" IMMEDIATELY if you experience any of the following symptoms:
-
your muscles tense uncontrollably during static exercises;
-
movement is no longer rhythmic and smooth during dynamic exercises;
-
you feel dizziness while treatment;
-
you feel pain while treatment;
-
you feel unwell, nauseous or experience cramping.
•
This unit is not suitable for use in damp environments.
•
Make sure that this user manual is kept with the unit at all times.
1.4 Environmental Conditions for Transporting and Storing the Unit
While still in its packaging, the unit can be stored and transported (for a maximum of 15 weeks) under the
following conditions:
•
Temperature Range: -20 °C - +60 °C;
•
Relative Air Humidity: 10 % - 100 %, including condensation;
•
Atmospheric Pressure: 500 hPa - 1060 hPa.
1.5 Using the Unit
The unit must only be operated by authorized and trained personnel (see Vibration Treatment). The
"fitvibe medical Pro" vibration unit is designed solely for vibration treatment.
The permissible temperature range during operation is +10 °C to +40 °C.
1.6 Conformity
MDD/CE
The “fitvibe medical Pro” has been developed and is tested, produced and sold according to the
international quality standards of the ISO 9001:2000 and EN 46003:1999 quality assurance system.
Furthermore, the “fitvibe medical Pro” meets the strictest requirements of European Directive 93/42/ECC
for Medical Devices (MDD), as indicated by the presence of a CE identification (CE 0197) on the
apparatus. Furthermore, the certifying authority (notified body), TÜV Rheinland/Berlin-Brandenburg, also
carries out checks regularly. This lets you, the treating physician, be certain that you are working with
equipment that meets all the requirements and that provides you and your patients with the best possible
levels of safety.
This unit conforms to the requirements of the low-voltage guidelines 73/23/EEC and EMC guidelines
89/336/EEC.
See Section 5 for details of manufacturer’s liability (FAULTS, GUARANTEE, MAINTENANCE AND
CLEANING).
