Quick Guide. for Treatment of Depression. with Brainsway dtms

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1 Quick Guide for Treatment of Depression TM with Brainsway dtms

2 Please be advised that this Quick Guide represents only a concise summary of some of the information contained in literature pertaining to the Brainsway TM manual for the operation of the Brainsway dtms system. As with any summary, this should not be construed as a complete or comprehensive dtms device, and may lack important information contained in other literature TM provided and/or made available by Brainsway, including but not limited to the instruction for use (IFU), and the relevant protocol. Please review all documentation pertaining to the device before use. Only personnel trained and certified by Brainsway authorized to operate the device. TM TM are

3 Preparing the Patient and the Device 1. TURNING ON THE STIMULATOR Turn on the stimulator by pressing the button on the back of the stimulator and pressing the black button on the front of the device. 2. SEATING THE PATIENT Seat the patient in a chair approximately 60cm/23.6" from the cart.

Preparing the Patient and the Device 3. INSERTING EARPLUGS 4. PUTTING ON THE CAP Have the patient insert earplugs into his/her ears, and ensure they are properly positioned.

4 Preparing the Patient and the Device 3. INSERTING EARPLUGS 4. PUTTING ON THE CAP Have the patient insert earplugs into his/her ears, and ensure they are properly positioned. Place the cap on the patient s head so that the front edge of the cap is attached to the forehead above the eyebrows. Make sure that the midline of the cap (the red line) is aligned with the midline of the patient s skull.

5 Preparing the Patient and the Device 5. ATTACHING THE STRAPS Pull the left and right peripheral straps and fasten them at the back of the patient's head. Fasten the cap s chin strap.

Measure the distance from nasion to inion. Note: All references to "left" and "right" in this document refer to the patient's left and right sides.

6 Preparing the Patient and the Device 6. USING THE BLACK RULER 7. USING THE RED RULER Attach the midline flexible ruler (black ruler) along the midline of the cap (on the right side of the patient), with the zero mark on the patient s nasion. Measure the distance from nasion to inion. Note: All references to "left" and "right" in this document refer to the patient's left and right sides. Place the lateral-medial flexible ruler (red ruler), so that the 25cm scale mark of this ruler lines up with the point along the black midline ruler (black ruler), whose distance from the nasion is 40% of the nasion-inion distance (Appendix A: nasion-inion distance). The zero mark needs to be on the left side. For example: in the case that the nasion-inion distance is 35cm, the red ruler should cross the black ruler at 14cm.

Determining the Motor Threshold (MT) 8. SETTING THE STIMULATOR Activate the stimulator in single pulse mode. Set the stimulator output power to an initial value of 50%.

7 Determining the Motor Threshold (MT) 8. SETTING THE STIMULATOR Activate the stimulator in single pulse mode. Set the stimulator output power to an initial value of 50%. Charge the system by pressing the green button. When the stimulator is charged, the system's status indication should change from "stopped" to "ready" and from red light to green light.

8 Determining the Motor Threshold (MT) 9. POSITIONING THE COIL FOR MT DETERMINATION Position the H-Coil over the patient's head so that the edge of the coil intersects the midline cap ruler at 7cm. Make sure that at this point the helmet edge is positioned at an exact parallel position to the blue cap edge and eyebrow line before you begin to tilt the helmet laterally. Note the location along the lateral-medial ruler where the edge of the coil is located (patient's left). Then rotate the coil 2cm to the right.

Determining the Motor Threshold (MT) 10. FINDING THE OPTIMAL POSITION Note Press the helmet firmly against the patient's head to find the minimal threshold.

9 Determining the Motor Threshold (MT) 10. FINDING THE OPTIMAL POSITION Note Press the helmet firmly against the patient's head to find the minimal threshold. Apply a single pulse Increase stimulator output by 5%. If no response is evident at 70% of the maximal stimulator output, consult the IFU. Is there a motor response? Anterior-Posterior Axis Lateral-Medial Axis STEP 1 STEP 2 STEP 3 STEP 4 Move the helmet 1cm in the anterior direction and apply a single pulse Move the helmet 1cm in the posterior direction and apply a single pulse Move the helmet 1cm in the medial direction and apply a single pulse Move the helmet 1cm in the lateral direction and apply a single pulse Is the motor response more pronounced? Is the motor response more pronounced? Is the motor response more pronounced? Is the motor response more pronounced? Move the helmet to the position with the best motor response along this axis and proceed to step 2 Move the helmet to the position with the best motor response along this axis and proceed to step 3 Move the helmet to the position with the best motor response along this axis and proceed to step 4 Move the helmet to the position with the best motor response along this axis (record this)

10 Determining the Motor Threshold (MT) 11. FINDING THE MINIMAL THRESHOLD Note If necessary use EMG (Appendix C: EMG) From optimal position, decrease the power output by 1% decrements Was there a response in at least 50% of trials? E.g., 4 trials out of 8 Adjust settings to restore previous power output. Threshold found (record this)

11 The Treatment 12. TREATMENT POSITION 13. TURNING ON THE COOLING SYSTEM Turn on the cooling system by pushing the button on the front panel of the cooling system (the temperature displayed on the screen must be 14 C or less before treatment can be initiated). Move the helmet 6cm along the cap s midline ruler in the anterior direction to the motor threshold (MT) location, but no further than the level of the eyebrows. Do not make any change in the lateral positioning.

12 14. COIL ATTACHMENT The Treatment Fasten the helmet to the patient s head using the chin straps. Fasten the rear string.

Performing the Treatment 15. ACTIVATING THE STIMULATOR Set the dtms Protocol: 18Hz at 120% MT, 2 second pulse train, 20 second inter-train interval, 55 trains.

13 Performing the Treatment 15. ACTIVATING THE STIMULATOR Set the dtms Protocol: 18Hz at 120% MT, 2 second pulse train, 20 second inter-train interval, 55 trains. Press the "Run Session" button on the stimulator screen (Appendix B: Stimulation Power). 16. STARTING THE TREATMENT Press the green button and then the yellow button to begin the treatment. If the treatment needs to be stopped for any reason, press the red button. X 36 Parameters Power: % value (120% of MT) Frequency: 18 Hz. Duration: 2 sec. No. of pulses: 36 Wait time: 20 sec. No. of trains: 55

14 Appendix APPENDIX A: NASION-INION DISTANCE (DN-I) APPENDIX B: STIMULATION POWER (120% OF MT) Nasion-Inion Distance (DN-I) Ruler Intersection (40% of DN-I) Nasion-Inion Distance (DN-I) Ruler Intersection (40% of DN-I) MT(%) Stimulation Power (120% of MT) MT(%) Stimulation Power (120% of MT)

APPENDIX C: EMG Appendix 1 2 3 4 Relax your arm and hand. Make sure that the baseline signal on the screen is relatively flat.

15 APPENDIX C: EMG Appendix Relax your arm and hand. Make sure that the baseline signal on the screen is relatively flat. Single Pulse Mode 1 Parameters: Time Base: 50ms Trace 1: 100 µv 2 Time Cursors: Status: ON L1: 17 L2: Amplitude Cursors: Status: ON Channel 1: X Display: Channel 1: X

Instruction For Use -OCD commercial. IFU Version No.: 05. Date: July 11, 2018 Page: Page 1 of 54. Name Position Date Signature

Document Name: Document No.: Instruction For Use -OCD commercial IFU-0039-00 Version No.: 05 Date: July 11, 2018 Page: Page 1 of 54 APPROVALS: Name Position Date Signature Dr. Yiftach Roth Chief Scientist