Otomat — Instructions for Use

Version of this IFU document: 1.4 from 2025-02-28.

The latest version can be found at https://otojig.com/IFU/otomat.html.

These IFU are valid for the following hardware/software:

OtoJig GmbH is the legal operator of this Otomat manufacturing machine. The user interface Otomatic in the form of an iPad app that connects via Bluetooth to the Otomat, is provided by OtoJig GmbH.

Contact / Support:

• https://otojig.com

• phone: +49 511 53859999

• eMail: support@otojig.com

Intended usage:

The point-of-care manufacturing machines (Otomat) are intended to be used by trained hospital staff or OtoJig technicians in a hospital environment to produce patient individualized Positioning Jigs (class I patient-matched medical devices; legal manufacturer OtoJig GmbH). The input is a blank Jig (without individualization; no medical device at this point in time) and one exported planned drill path, e.g. coming from the surgical planning software (software as a medical device) named conCIerge. For the planned path, the machine automatically creates a stepped through-hole in the blank Jig at the planned position and in the planned angle and with the planned drill depth. The user shall check that the production finished without anomalies by visually inspecting the produced Positioning Jig, and confirm this in the user interface.

Only for process validation purposes, technicians shall be able to change certain production parameters (RPM, forward movement speed).

Inputs

• A blank Jig

• An exported drill path in JSON format

Outputs

• A Positioning Jig (medical device) with a through hole corresponding to the exported drill path.

What you need

• Otomat (machine)

• iPad with internet access

• Power cord

• User training in the usage of the machine

User interface

Most functions of the Otomat are controlled using the Otomatic app on the iPad. In addition there are several physical interfaces on the Otomat:

• Power switch On the side of the Otomat there is a turnable power switch. The light inside of the Otomat indicates if the Otomat is powered on.

• Emergency stop (e-stop) See section warnings & precautions

• Door The front door is typically opened by the device automatically by pressing the LED hardware button (glowing cyan or yellow, see below) and slides upwards/downwards. Manually opening the door will cancel the production.

• LED hardware button The button in the front is used for several functions. The build in LED indicates what will happen upon a short press:

  • cyan: open door

  • yellow: close door

  • green: confirm starting of production steps

  • red: cancel production in a soft way. This will make sure the drill does not get stuck in the jig, but will take time. In case of doubt, always press the emergency stop.

  • violet: clearance after e-stop reset. See section warnings & precautions

  A Long press of this button will activate certain bluetooth functions, See section Setup instruction - Connecting to Otomat.

⚠️ Warnings & precautions:

Emergency stop (e-stop):

In case of emergency or malfunction, press the e-stop (labelled "NOT AUS") to immediately stop all movements of the device.

Device operation:

Setup Instructions:

1. Install the Otomatic App:

   • Download and install the Otomatic app from the link provided by OtoJig on one of the supported iPad models.

2. Allow Bluetooth

   Note
   

   The app will request access to Bluetooth. Make sure to "Allow" the use of Bluetooth.

   

3. Connect and Power On:

   • Connect the Otomat cord to a power source.

   • Turn on the switch on the side of the Otomat. 

4. Wait for Device Readiness:

   • Wait until the button on the Otomat starts blinking, indicating it’s ready for connection.

5. Login to the Otomatic App:

   • Open the Otomatic app on your iPad.

   • If you do not have an account, tap the "Register" button to create a new account.

   • After registering, contact OtoJig to activate your account.

   • Use the login information to log in.

6. Connecting to Otomat:

   • In the Otomatic app, navigate to the "Connect" view.

   • When first connecting an iPad to the Otomat, the devices need to be paired.

     • To do so, keep the LED hardware button pressed for 5 seconds until the button starts blinking blue. The Otomat remains pairable for 30 seconds. Afterwards the button changes to its previous mode.

     • While the Button is blue, tap on the Otomat device name in the Otomatic app.

     • A popup will appear asking if you want to pair the iPad with the Otomat. Tap “Yes” to confirm.

• You should see your Otomat device listed. If not, tap the refresh button () in the top-right corner of the screen.

• Tap on the Otomat device name or image to connect to that machine.

7. Check Bluetooth Connection Status:

• You can monitor the Bluetooth connection status from the Otomatic app.

Follow these steps to successfully set up and pair an Otomat with your iPad. If you encounter any issues, refer to the troubleshooting section or contact customer support for assistance.

How to Use the Otomatic App:

To successfully complete a production process, follow these steps using the app. The app is designed to guide you through each stage, making the individualization of a Positioning Jig easy and efficient. Follow the setup instructions to power on and connect to an Otomat. The Otomat has a "LED hardware button", which is a physical button on the machine located left of the e-stop.

This LED hardware button can light in different colors and has different functions depending on the step of the workflow (left of the e-stop in the following picture. In the picture it is neutral, not glowing in a color):

After connecting to an Otomat, the following view is displayed in the Otomatic app:

① You can find the user manual and contact information for Otojig.

② Advanced machine settings for manufacturing.

③ Use to log out or switch users.

④ Displays the production workflow.

⑤ Displays connection status: a green light indicates a stable connection, while a gray light indicates disconnection.

⑥ Displays machine information.

⑦ If the drill path is loaded, the light will turn green, and you can view drill path details.

⑧ This view will update during production, guiding you through the next steps of the process.

⑨ Tap the image to scroll through pictures or zoom in.

1. Power on the Otomat (see setup instructions)

2. Connect to the Otomat (see setup instructions)

3. Initial Safety Check:

   • In the first step, confirm that the drilling environment is safe and free of any inappropriate items. Then, start the process.

4. Otomat Initialization:

   • Wait until the Otomat finishes initializing.

5. Mount the Blank Jig:

   • Press "Next" to begin mounting the blank jig.

   • The LED hardware button will light blue. Press the LED hardware button to open the Otomat door.

   • Follow the step-by-step instructions in the app to mount the blank jig correctly. Note: You can zoom in on images by tapping them in the bottom-left corner of the screen.

   • Make sure the jig is securely fixated with Jig Fastener.

6. Scan the QR Code:

   Note: The app will request access to the camera. Make sure to accept the permission to ensure proper functionality

   

   • There's a QR code on each Jig. press the "Take a Picture" to scan the QR code.

   • The iPad will close the window as soon as it detects the QR code.

     Note
     

     If the QR code isn't detected, try adjusting the distance or angle slightly.

     

7. Transfer the Picture:

   • After scanning the QR code, press the "Transfer Picture" button.

8. Close the Door:

   • The LED hardware button will light in yellow. Press it to close the door.

9. Select the Drill Path:

   • Press "Next," and the LED hardware button will turn green.

   • Choose the drill path you want to use for drilling.

     

     Note
     

     If you've planned the drill path using another device, transfer it to the iPad via AirDrop.

   • Double-check the patient ID and operation ID to ensure the correct drill path is loaded.

     Use the "Reset" button ① if you need to change the drill path.

     Note
     

     If reset button is not available and you want to reset the drill path press the red LED hardware button to abort drilling

10. Start Drilling:

• Press the green button and wait for the positioning to complete.

• Press the green button again to start drilling.

• Wait until the drilling is complete.

  Note
  

  If you want to abort the drilling process you can press the red button

11. Next Steps:

    • If you need to drill another hole on the same jig, press "Next Drilling." If not, press "Takeout Jig."

    • The hardware button will turn blue. Press it to open the Otomat door.

12. Complete the Production:

    • You've successfully completed a production! If you need to drill another jig, press "Next Jig." If not, press "Done!"

Maintenance & Cleaning:

Regular maintenance

According to Prautec's Operating instructions for Otomat, Chapter 11 "Maintenance" - Wartungsplan.

Cleaning instruction

The cleaning aims at eliminating jig production residues and potential contamination and to ensure the continued performance of the machine for future use.

The following cleaning steps additional to Prautec's Operating instructions should be taken after or before each use:

• Wearing medical gloves, remove any visible production shavings from the inside (can be swept into the drawer).

• Wipe the end effector plate with disposable alcohol wipes (disinfectant wipes). Observe the minimum cleaning time specified by the wipe manufacturer.

• Allow the cleaned area to air dry.

In addition to the steps mentioned above, the production shavings drawer must be emptied and cleaned regularly to avoid blockages or potential contaminants.

Troubleshooting:

Bluetooth connection problems:

1. Go to your iPad's Settings > Bluetooth > My Devices.

2. Remove the Otomat device from the list.

3. On the Otomat, press and hold the LED hardware button for 3 seconds, then it will start blinking

4. Try to connect to the Otomat again (paragraph 5)

5. If still have a problem with bluetooth contact OtoJig

Abort:

• After abort you can press "Redo" to drill on current jig with the selected drill path or you can press "Takeout" to takeout the jig and finish the process

  abort reasons:

  • User pressed red glowing LED hardware button: you can press "Redo" to drill on current jig with the selected drill path or you can press "Takeout" to takeout the jig and finish the process

  • Hexapod position out of limits : means the drill path is not valid for hexapod please change the drill path and then try again.

  • Speed not reached: for installation activities contact OtoJig

  • Error in set sequence: for installation activities contact OtoJig

Recover after e-stop:

If the process gets stuck after pressing of the e-stop and you can not recover, restart the machine by turning off the power, wait for approx. 5 min until the light in the button turns off and turn the machine on again.

QR-code not detected:

1. If the QR code isn't detected, try adjusting the distance or angle slightly.

2. If the QR code is not clear please use another jig and continue the production.

Jig quality insufficient:

• Retry with another blank Jig.

• If this does not help, contact OtoJig support.