Medical device manufacturer, Cyclomedica, has issued a medical device safety alert concerning TechnegasPlus Generator [Model Number: 25000; Affected Serial Number in Hong Kong: TG992401, TG33615, TP062609, TP071708, TP84308, TP091906, TP151206 and TP161904].
On 24 May 2019, the manufacturer was performing conducted emissions certification testing on the TechnegasPlus Generator to CISPR 11, the TechnegasPlus Generator recorded a measurement above the upper limit for Class A conducted emissions. Specifically, the out-of-specification reading occurred during the 17 second burn cycle on the active line testing while assessing quasi-peak levels:
According to the manufacturer, the incident did not occur in clinical use. The issue was discovered during testing at the manufacturer site. Conducted emissions do not have an impact on the safety of users of the TechnegasPlus Generator or patients undergoing a Technegas examination or the performance of the product.
While the conducted emissions of the TechnegasPlus Generator are above the Class A limit, medical devices in in the same environment as the TechnegasPlus Generator and those connected to the same supply mains as the affected device are likely to be certified to IEC 60601-1-2 ed. 3 or ed. 4. However, the out of specification may cause other devices not certified to IEC 60601-1-2 ed. 3 connected to the same power supply in the healthcare facility to exhibit abnormal behaviour depending on how the power supply network in the hospital or clinic is configured during the maximum 17 seconds the burn cycle is occurring.
IEC 60601-1-2 ed. 3 requires medical devices to be immune to conducted mains disturbances in the frequency range 150 kHz to 30 MHz with an amplitude of at least 3V ( ~ 130dBµ V). The measured conducted emissions generated by the TechnegasPlus Generator are significantly below this limit; therefore, medical devices certified to the IEC 60601 standard should be immune to the TechnegasPlus Generator conducted emissions even though the measurements are above the Class A limit.
The manufacturer is taking the following corrective actions and preventative actions:-
Affected users should review the Field Safety Notice and await contact from the manufacturer or its Service Provider to arrange on site visit to apply correction; or should contact the manufacturer or Service Provider if needed.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 June 2019