# ROSA user manual






## Operating principle
### Preoperative image acquisition


- Load and select the images to display
1. Select an exam for the 3D reconstruction of the patient’s head
2. Select an exam to display as first exam
3. Select another image to display as second exam(optional)
4. Select and merge an atlas (optional)
5. Select the two X-Ray images to display (optional)

- Exams can be imported by different means: through the PACS (network), from a peripheral device (Imaging system),and portable media (CD, DVD and USB flash drive).
- Medical imaging exams are recorded in the DICOM (Digital Imaging and Communications in Medicine) format,a standard used for digital medical images published by the National Electrical Manufacturers Association (http://medical.nema.org). These exams are imported to the planning station and the ROSA PC (inside theRobot stand). Refer to the document Acquisition protocol for detailed information about DICOM acquisition properties and recommendations.






### Preoperative planning




### Patient & device installation

- Device orientation


- Distance between head and device



- Head holder support arm


- For procedures that require maximal rigidity of patient's head attachment (eg. DBS, SEEG), it is recommended to use a stereotactic frame.


- Force sensor calibration
- Before installation of any tool, the user is asked to calibrate the force sensor without any tools mounted on the robot arm



- Pointer probe installation
- Fix the pointer probe at the robot arm tip in case of a marker registration


- Distance sensor installation
1. Use the provided screws to fix the distance sensor on the robot arm in case of a surface registration
2. Plug the distance sensor connector on the corresponding cable at the robot arm tip
3. On the device rear panel, switch off and then switch on the distance sensor.
4. Calibrate the distance sensor by clicking on Start


- Distance sensor calibration
1. Check the serial number of the calibration tool
2. Use the provided screws to fix the calibration tool on the distance sensor
3. Calibrate the distance sensor by clicking on Calibrate
4. Remove the calibration tool from the distance sensor

### Patient registration



- It is recommended to choose a registration method that will provide the degree of accuracy required for the procedure.
- The device offers several methods of registration that can provide various degrees of accuracy; the table below provides an overview of the methods and corresponding expected accuracy. For procedures that require higher precision, such as ++**DBS**++, bone fiducials or stereotactic frame registration may be appropriate.For other procedures ++**(e.g. SEEG)**++ where accuracy is not as critical, a preferred registration method may be used.

- Fiducials registration


- Skin fiducials

- The accuracy of the skin fiducials registration is highly dependent on the number of fiducials and their positions on the patient's head. It is ++strongly recommended to use at least **5 fiducials.**++
- The markers must be distributed over the patient's head non-symmetrically and should not be placed in the same plane. Itis recommended to place the fiducials near the area of interest and to avoid areas of the head that might move during the procedure.


- Bone fiducials





- Surface matching registration



- initial points (robot)


- initial points (robot manaul and auto)




- Scan Zone (Robot)



- On this interface, a 3D view of the patient's head is displayed. The user can see a blue cross representing the scanned points during the cross scan and the initial points collected with the distance sensor.




- Stereotactic frame registration


- [Elekta : Quick Reference Guide, Leksell® Coordinate Frame G](https://ecatalog.elekta.com/neuroscience/stereotactic-neurosurgery/products/19051/20366/22145/20231/stereotactic-neurosurgery/leksell-g-frame-and-arc-spare-parts/leksell-coordinate-frame-g/quick.aspx)


- in pre-operative 3D(CT)



- in intro-operative



### Patient & device draping





### Instrument holder positioning

- The surgeon mounts the instrument holder and adaptor on the robot arm and sends the robot onto the selected trajectory




- Instructions to mount surgical instruments on adaptors

### Instrument guidance

- Cooperative mode
- Micro move in stereotaxy
- Micro move in endoscopy


### Implant placement
### Intraoperative control

- 2D X-ray images registration

- In frame-based stereotaxy, the Leksell frame X-Ray plates are mounted on the Leksell frame. If the frame is already registered, the 2D image can be registered directly with the frame. Once the image has been loaded the following registration window is shown:

- Registration of a pair of 2D AP and LAT images acquired with a Leksell frame
- The detection of the frame in the image is performed using the Leksell frame X-ray plates. These plates are fixed on the Leksell frame during acquisition.
- There are 4 radiolucent plates (AP, LAT), each containing 4 radio-opaque markers. The 16 markers must be identified on the AP and LAT X-Ray images as shown below:
- The 8 markers E, F, G, H and M, N, O, P of the front and rear plates must be identified on the AP image.
- The 8 markers A, B, C, D and I, J, K, L of the left and right plates must be identified on the LAT image.

## Recommendation to guarantee the performance of the device


## Other

- Non-sterile


- Sterile


- trouble shooting