Environmental Conditions For Transport And Storage; Using The Fitvibexcel Pro Medical; Conformity - Fitvibe Medical Fitvibexcel Pro Medical User Manual

1.4.

Environmental conditions for transport and storage

While packaged, the Fitvibexcel Pro Medical can be transported and
stored (for a maximum of 15 weeks) under the following conditions:
• Temperature range: -20° C to +60° C
• Relative humidity: 10% - 100% including condensation. (please allow
device adjust to local temperature before switsching it on.)
• Atmospheric pressure: 500 hPa – 1060 hPa
1.5.

Using the Fitvibexcel Pro Medical

The unit must only be operated by authorised personnel. Before you
start using the Fitvibexcel Pro Medical for the first time, please make
sure you have read and understood all information provided in this
User Manual.
Familiarity with the information and instructions contained in this
manual is an essential requirement to ensure efficient and optimal
use of the system, to avoid dangers to persons and to the equipment
and to obtain good results.
The Fitvibexcel Pro Medical vibration platform is designed solely for
vibration training and/or treatment. The Fitvibexcel Pro Medical can be
operated at ambient temperatures of +10° C to +40° C.
1.6

Conformity

The Fitvibexcel Pro Medical has been developed and is produced,
tested and sold according to the international quality management
standards EN ISO 9001 and EN ISO 13485. Furthermore, the
Fitvibexcel Pro Medical meets the strict requirements of European
Medical Device Directive 93/42/EWD, as indicated by the presence
of a CE mark (CE0197) on the apparatus. The Fitvibexcel Pro Medical
conforms to all of the relevant EMC directive and standard EN 60601-
1-2 (IEC 60601-1-2) requirements when used in conjunction with
the accessories recommended by the manufacturer. This device
User manual Fitvibexcel Pro Medical
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