Empi 300PV Manual De Instrucciones página 10

• Do not operate this unit in an environment where other devices are being used
that intentionally radiate electromagnetic energy in an unshielded manner.
Portable and mobile RF communications equipment can affect Medical
Electrical Equipment.
• This unit generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. Harmful interference to
other devices can be determined by turning this equipment on and off. Try to
correct the interference using one or more of the following: reorient or relocate
the receiving device, increase the separation between the equipment, connect
the equipment to an outlet on a different circuit from that to which the other
device(s) are connected and consult the Empi RepairDepartment for help.
• Patients with an implanted electronic device (for example a cardiac pacemaker)
should not be subjected to stimulation unless specialist medical opinion has
first been obtained.
1.8 Dangers
• Stimulus delivered by the TENS waveforms of this device, in certain
configurations, will deliver a charge of 25 microcoulombs ( C) or greater per
pulse and may be sufficient to cause electrocution. Electrical current of this
magnitude must not flow through the thorax because it may cause a cardiac
arrhythmia.
1.9 Adverse Reactions
Skin irritation and burns beneath the electrodes have been reported with the
use of TENS/NMES.
Glossary of Symbols
Refer to ACCOMPANYING DOCUMENTS
Type BF Equipment
The notified body, TÜV Product Services ID 0123, has
granted Empi an EC Certificate according to Annex II, Clause
3 of Council Directive 93/42/EEC Concerning Medical
Devices (Medical Device Directive).
Medical Equipment with respect to electric shock, fire and
mechanical hazards only in accordance with UL 2601-1, and
CAN/CSA C22.2 No. 601.1-M90
11N1
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