Dantec Clavis User Guide
7
Contraindications
Patients with an implanted electronic device, e.g., a cardiac pacemaker or with cardiac abnormalities
should not be subjected to electrical stimulation unless specialist medical opinion has first been
obtained.
Please refer to contraindications for implant systems for further information on
pacemakers.
Warnings
The device is not intended for cardiac application.
Do Not apply electrodes:
1.
Over the thoracic area
2.
Over the left and/or right temporal regions
3.
In the orbital region
Use in an anesthetic environment: The Dantec Clavis system is not suitable for use in presence of a
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN or NITROUS OXIDE.
This device must not be used simultaneously with other equipment, or near other equipment, which
might give off electrical energy.
The device is not compatible for use in an MRI magnetic field.
Do not immerse the device in any liquid.
Cautions
Always read the instructions accompanying the needles/electrodes used.
In conditions with bleeding tendency, certain care should be taken when needles are used.
Conventional precautions should be taken with patients with infectious diseases and broken skin.
Dantec Clavis cannot be sterilized.
After using an alcohol prep to clean the skin, make sure any flammable liquid and/or vapors have
evaporated and dispersed before using the instrument.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Dantec
Clavis System, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and
hospitals as well as residential environments. This equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take mitigation
measures, such as relocating or re-orienting the equipment.
The Dantec Clavis system should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the system should be observed to verify normal operation in
the configuration in which it will be used. Refer to the Recommended Separation Distances
table in the Safety & Standards Conformity section for minimum recommended
separation distances.
