1.1 Surgery Training Certificate

2.1.a I have reviewed / access to the following directSTIM Manuals and documentation:

1 - PR-12000 Information for Prescribers
2- PR-11506 Implant Manual for Leads
3- PR-12001 Implant Manual for Stimulator
4- PR-12002 Device Registration Form
5 - PR-12100 Implant Manual for Extensions
6 - PR-12003 Patient ID Card
7 - PR-12004 Limited Warranty

2.1.b I am aware of all the Important Safety Information and Contraindications. The procedures listed below must NOT be used on patients that are implanted with the directSTIM DBS System: MRI, Diathermy, Electroconvulsive therapy (ECT), Monopolar electrocautery, Monopolar electromyography (EMG), Radiofrequency (RF) or microwave ablation, Transcranial magnetic stimulation therapy (TMS)

Yes No

2.2. I understand that the directSTIM system can only be used with approved accessories as described in the directSTIM Implant Manuals (bone plate, screws, tunneling tool, guide tube and trial cable).

Yes No

2.3. I understand that before opening any directSTIM sterile package, the model number, use-by date, and package integrity must be verified.understand that the directSTIM system can only be used with approved accessories as described in the directSTIM Implant Manuals (bone plate, screws, tunneling tool, guide tube and trial cable).

Yes No

2.4. I am aware not to implant a directSTIM lead if the lead or lead accessories were damaged during the procedure. Damage includes breaking, cutting, nicking, flattening, or stretching the lead or lead accessories.

Yes No

2.5. I understand that special care must be taken when handling and/or coiling the directSTIM leads and extensions.

Yes No

2.6. I understand that special care must be taken when using and tightening the directSTIM depth stop adapter

Yes No

2.7. I understand that the use of the provided guide tube adapter is mandatory to avoid damage to the directSTIM electrodes.

Yes No

2.8. I understand that special care must be taken when screwing the anchoring sleeve.

Yes No

2.9. I understand that special care must be taken when performing lead-to-extension / extension-to-stimulator connections, also when using the connector boot and set-screw.

Yes No

2.10. I understand the properties of the directSTIM level markers (“Bright areas” indicate the location of the electrode sites).

Yes No

2.11. I am trained on how to wake-up, charge and prepare the directSTIM IPG before implantation.

Yes No

2.12. I understand that special care must be taken when positioning the directSTIM IPG and extension into the subcutaneous pocket.

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.