AS 60601.2.10:2018 Medical electrical equipment
201 .7.9.2.1 01 Additional information in instructions for use
The instructions for use shall contain additionally:
a) * Information on the output WAVEFORM ( S ), including any d.c. component, PULSE DURATIONS ,PULSE repetition frequencies, maximum amplitude of output voltage and/or current, and the effect of load impedance on these parameters.
b) * Advice on the size and type of electrodes to be used and the method of application for each particular type of treatment for which the STIMULATOR is intended.
c) Advice on any necessary precautions to be taken when the output contains a d.c.component.
d) * Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained.
e) A warning on the following potential hazards:
– Simultaneous connection of a PATIENT to a high frequency surgical ME EQUIPMENT may result in burns at the site of the STIMULATOR electrodes and possible damage to the STIMULATOR .
– Operation in close proximity (e.g. 1 m) to a shortwave or microwave therapy ME EQUIPMENT may produce instability in the STIMULATOR output.
– Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
f) * For ME EQUIPMENT capable of delivering output values in excess of 1 0 mA or 1 0 V:
– Information on maximum output values available at the electrodes recommended by the manufacturer for use with the STIMULATOR .
g) Advice that any electrodes that have current densities exceeding 2 mA/cm 2 may require the special attention of the OPERATOR .
h) Advice that stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on the front of the neck, (especially the carotid sinus), or from electrodes placed on the chest and the upper back or crossing over the heart.
201 .1 2.1 .1 01 * Output amplitude
A means shall be provided to control the STIMULATOR output from minimum to maximum continuously, or in discrete increments of not more than 1 mA or 1 V per increment. At its minimum setting, the output shall not exceed 2 % of that available at the maximum setting of the control.
Compliance is checked by inspection and measurement using the load impedance which is the least favourable within the load impedance range specified in the ACCOMPANYING DOCUMENTS .