1. C01H063 rev 001

2. Respiratory Motion Effect in Radiation Therapy Relevant Sites: Thorax, Abdomen, Pelvis, Left Breast C01H063 rev 001

3. Respiratory Motion Effect in Radiation Therapy Relevant Sites: Thorax, Abdomen, Pelvis Imaging: Artifacts can cause distortion of the target and OARs volume and position (OARS = Organs At Risk) C01H063 rev 001

4. Respiratory Motion Effect in Radiation Therapy Interested Sites: Thorax, Abdomen, Pelvis Imaging: Artifacts can cause distortion of the target and OARs volume and position Treatment Planning: Because of the artifacts registered during imaging acquisition, larger margins are needed for ensuring adequate target coverage. C01H063 rev 001

5. Respiratory Motion Effect in Radiation Therapy Relevant Sites: Thorax, Abdomen, Pelvis Imaging: Artifacts can cause distortion of the target and OARs volume/position Treatment Planning: Because of the artifacts registered during imaging acquisition, larger margins are needed for ensuring adequate target coverage TREATMENT DELIVERY: blurring of the static dose distribution that causes a deviation between the planned and the actual delivered dose distributions. Stronger effects with treatment plans characterized by steep dose gradients and high modulation degrees C01H063 rev 001

6. Voluntary Breath Hold Technique Intrafraction motion and in particular respiratory motion, causes inaccuracies in the radiation therapy treatments. The patient is being asked to independently hold their breath at some point in the breathing cycle: Inspiration (70-80%): DIBH (Pictured) Exhale Shallow Breathing Radiation will be delivered during the Shallow Breathing phase. Target motion is considerably reduced together with anatomy variations Benefits for the OARs C01H063 rev 001

7. Expandable bellows system Base unit 3 LED display LED display mount Measurement tool Wireless extension kit C01H063 rev 001

8. Expandable bellows system Base unit 3 LED displays LED display mount Measurement tool Wireless extension kit C01H063 rev 001

9. Expandable bellows system Base unit 3 LED displays LED display mount, multiple versions available Measurement tool Wireless extension kit C01H063 rev 001

10. Expandable bellows system Base unit 3 LED displays LED display mount Measurement tool Wireless extension kit C01H063 rev 001

11. Expandable bellows system Base unit 3 LED displays LED display mount Measurement tool Wireless extension kit C01H063 rev 001

12. SYSTEM ARCHITECTURE C01H063 rev 001

13. WORKFLOW Determine if the patient is a valid candidate for the Breath Hold ES Monitor the patient in order to understand the area of maximum breathing induced by thorax/abdomen extension Planning CT: Set/Confirm Breath Hold Sensitivity Place belt on patient and connect the bellows belt to the base unit Position the gooseneck and the display Position reference markings on the patient where belt is placed using tattoos, markers, tape, etc. C01H063 rev 001

14. WORKFLOW Have the patient take an initial comfortable breath in and hold Zero the system (Reference Point) Teach the patient to achieve desired breath hold or to breathe around the comfortable breath with the use of the LED light indicators Acquire the CT images Take the belt off the patient and insert it into the measurement tool Expand bellows to illuminate the single red light, record the measurement using the measurement tool Expand bellows to illuminate the top of the light range desired for patient, record the measurement using measurement tool (shallow breathing) Contract bellows to illuminate the bottom of the light range desired for patient, record the measurement using measurement tool (shallow breathing) C01H063 rev 001

15. WORKFLOW During All Following Treatment Sessions: Set/Confirm sensitivity setting used in CT simulation Expand the bellows with the measurement tool to the recorded breath hold position Place the belt on the patient using previous reference points Initiate treatment when the patient is at desired breath hold point or in between the light ranges determined in CT Sim C01H063 rev 001

16. SENSITIVITY CHART The system sensitivity is a choice of the user, having 5 different preset levels to choose from. C01H063 rev 001

17. CANDIDATES IGRT treatments Thorax, Abdomen, Left breast Shallow breathing DIBH Improved contouring on CT Images Great reproducibility Easy, fast and comfortable system set up Not invasive (no spirometer) Portable and standalone All LINACS No software No external devices ( implanted markers, infra-red cameras, etc…) C01H063 rev 001