Dantec Clavis User Guide
6
Safety Information
Safety Requirements
This device is intended to be used by qualified medical personnel, knowledgeable in the field of
electrophysiology and with the appropriate education and special training. Before using the instrument,
please read these operating instructions carefully. Follow the warnings indicated on the instrument and
the safety precautions recommended in this manual.
This device has been designed and tested in accordance with the IEC Publication 60601-1 (EN 60601-1)
Medical Electrical Equipment.
Do not use this device for anything other than what it is intended for by the manufacturer. Natus Neuro
assumes no responsibility when not used as described in this user guide.
Medical electrical equipment needs special precautions regarding EMC, and requires installation and
servicing according to the information provided in this user guide.
The device has been designed for indoor use at temperatures b10°C and +40°C (+50°F to +104°F).
Situate the unit away from heat sources such as radiators and warming lamps as exposure to high temper-
atures may affect operation or cause damage.
Do not use damaged or defective devices. Protect this instrument from immersion, spills, the impact of fall-
ing objects, and exposure to excessive smoke, dust, mechanical vibration, or shock.
Any serious incident that has occurred in relation to the Dantec Clavis device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is
established.
Intended Use
Dantec Clavis is a medical device intended as a stimulator for nerve localization as well as an aid
for guidance of injections into the muscles.
Essential Performance
Essential performances of the Dantec Clavis product are identified in the standard IEC 60601-2-40:2016
specifying requirements for the basic safety and essential performance of electromyography and evoked
response equipment. Essential performance relates to the quality of the signal recorded from the
amplifier.
In the EMG mode:
The essential performance for Dantec Clavis supports needle electrode examinations.
Throughout the procedure, Dantec Clavis will emit a series of audible signals varying in intensity and
frequency that will help monitor the localization of the targeted muscle or nerve.
Additional essential performance also includes the ability of the health care professional to inject
any necessary drugs to the patient through the use of the Bo-ject needles.
Stimulation Mode:
The Clavis system can apply a current pulse train to the patient.
The Stimulation Level bar facilitates the monitoring of the stimuli.
