Unexpected Symptoms; Electrical Safety; Prevention Of Explosion; Liability - Fitvibe smart User Manual

1.3.3 Unexpected symptoms

A user must immediately stop using the fitvibe smart when any unexpected
symptoms occur. Examples are:
Muscle contractions without control during static exercises.
Irregular movement of the device during dynamic exercises.
Dizziness
Pain
Muscle tightness
Nausea

1.3.4 Electrical Safety

Only use the equipment in an area with facilities that meet the applicable legal
regulations.
Connect the equipment to an outlet with a protective earth terminal. The outlet
must meet the locally applicable requirements.
Fitvibe smart has been manufactured for use at a power voltage of either 230V,
50-60Hz or 115V, 50-60Hz. Check the type shield for compatibility. Use of the
device at an unsuitable voltage can cause irreparable damage

1.3.5 Prevention of explosion

Do not use the equipment in an area where combustible gases or vapours are
present.
Switch off the equipment when it is not used.

1.3.6 Liability

Neither the manufacturer nor the local dealer can be held liable for personal injuries
or for damage to or by the equipment used, if for example;
The equipment or the accessories are used incorrectly
The user instructions are wrongly interpreted or ignored
The equipment is badly maintained
Maintenance or repairs are performed by people or organisations that are not
authorized to do so by Uniphy Elektromedizin.

1.3.7 Conformity

MDD/CE
The fitvibe smart has been developed and is tested, produced and sold according to
the international quality standards of the ISO 9001:2000 and DIN EN ISO
13485:2003 quality assurance system. Furthermore, the fitvibe smart 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.
For the manufacturer's liabilities, see Chapter 4.
8
Fitvibe SMART