5.1 Training on Patient Programmer & Charger – Training Certificate

3.1. I have received / access to the following directSTIM manuals and documentation:

PR-12000 Information for Prescribers PR-12200 Clinician Programming Manual PR-12300 Patient Manual PR-12002 Device Registration Form PR-12003 Patient ID Card PR-12004 Limited Warranty

3.1. I am aware of all the Important Safety Information and Contraindications. The proce-dures listed below must NOT be used on patients that are implanted with the di-rectSTIM DBS System: MRI, Diathermy, Electroconvulsive therapy (ECT), Monopolar electrocautery, Mono-polar electromyography (EMG), Radiofrequency (RF) or microwave ablation, Tran-scranial magnetic stimulation therapy (TMS).

Yes No

3.11. It is my responsibility to ensure that the patient is informed of the contraindications to directSTIM DBS System.

Yes No

3.12. It is my responsibility to ensure that the patient is trained on the use of the directSTIM PPC, charging paddle and adjustable harness.

Yes No

3.13. It is my responsibility to ensure that the patient is trained on how to stop/restart the stimulation using the directSTIM PPC or the Magnet.

Yes No

3.14. It is my responsibility to ensure that the patient receives a properly filled directSTIM Patient ID card.

Yes No

3.15. It is my responsibility to ensure that the patient is informed that he needs to contact his physician in case of skin reaction while using the directSTIM harness.

Yes No

By completing and submitting this form, the trainee confirms that he was provided the aforementioned training and consents to inform Aleva of the need to repeat training or train another staff member involved in the use of the directSTIM DBS System.

We are the only European Company that designs, manufactures, and commercialises DBS devices for the treatment of Parkinson’s disease and essential tremor.

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