Epijet®

First automatic injection unit for ictal SPECT, Epijet® meets the needs of both radiation protection and rapid injection of the cerebral infusion agent necessary for the precise localisation of epileptogenic foci before surgery.

This injection unit results of an active collaboration between Dr Setoain (Hospital Clinic de Barcelona) and Lemer Pax. Combining business and technical expertise to obtain an innovative solution adapted to this specific diagnostic examination.

The Epijet injection unit® is a medical device designed for rapid and radiation protected administration of a radiopharmaceutical drug, also known as ^99mTc- HMPAO or ^99mTc-ECD cerebral infusion agent. It is used in the context of neurological activity for patients suffering from epilepsy. And for whom an ictal SPECT examination is prescribed in order to precisely localise epileptogenic foci prior to any surgical intervention.

Epijet®, first automatic injection unit for ictal SPECT

Easy to handle, the injection unit can be easily and quickly positioned in the cubicles or injection rooms. In which the patients are installed until the epileptic seizure occurs. The preparation of the radiopharmaceutical must first be carried out in a shielded hot cell adapted to the 140 keV gamma radiation emitted by the ^99mTc radioisotope. Then, it is being positioned in the injection unit via a 4 mm lead shielded cassette. Ensuring adequate radiation protection for the operator. Lastly, the patient is then connected to the Epijet® injection unit until the seizure occurs or the radiopharmaceutical expires.

The operator can trigger the injection in two ways:

• either directly from the control panel on the injection unit
• or by remote control (optional) which allows for greater speed of execution, optimisation of user radiation protection and greater respect for the patient’s privacy.

Epijet® automatically adapts its injection thresholds with the patient’s prescription. That way it is taking into account the radioactive decay of the radiopharmaceutical in real time. It allows the user to be totally available for patient monitoring. The administration time of the infusion agent is less than 5 s and can be easily adapted by the operator.

Epijet® component parts

Epijet® automatic injection unit is composed of:

• a control screen incorporating the control software. This software allows the user to identify a dose, associate a patient with it and check all the data entered to activate the injection. That way, it automatically adapts the amount of infusion agent to be injected according to the decay of the radiopharmaceutical during the waiting time before the epileptic seizure
• the quick control panel physically controls the device with two simultaneous injection buttons and an injection unit ignition button. A USB port is also available to allow the export of data corresponding to the injected dose.
• two-wheel steering ensures extreme manoeuvrability of the injection unit
• a 4 mm lead shielded cassette. It holds the injection kit including the 10 mL syringe containing the prepared dose and the 5 mL rinsing syringe. A manifold of taps connects these two syringes. The cassette is positioned vertically in the injection unit.
• the locking system allows secure access to the prepared dose during the waiting phase.

Complies with EU regulations (UE) 2017/745, standards EN 60601-1:2006 (+ A1/2013), EN 60601-1-2:2015, EN 60601-1-6:2010 (+ A1/2015), EN 62366 : 2015 (+ A1/2020), and EN 62304:2006 (+ A1/2018).