User Manual
General Information
This user manual describes rTOP functionalities and operation.
Caution
rTOP is restricted to be used by on the order of a qualified clinician.
At this time, rTOP is approved as an ITAV product in Europe. We are planning approval as a medical device according to MDR in Europe for mid-2025. rTOP is already developed and tested according to medical device standards. For the USA, rTOP is approved as a medical device.
Device Description
roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard. The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times. The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. In addition to enabling remote access and control of the modality scanners, rTOP also supports common communication methods including live videos, audio calls and text chats among users.
Warnings
This chapter lists the warnings and prerequisites for the use of rTOP. Read them carefully and contact the manufacturer, if you have any open questions.
Prerequisites
To operate rTOP safely and according to its intended use, the following prerequisites must be met:
- The user has read and understood the Indications for Use, Warnings, and Operating Instructions included in this user manual.
- The local operator is trained on the controlled device. The local operator is at any time responsible, that all risk mitigations of the controlled device stay in place.
- Only use rTOP with the supplied cables and components (camera, speakerphone, …). The use of other cables or accessories may negatively affect EMC performance.
- rTOP shall be installed, so that during normal use the back side of the roclub Connector cannot be reached.
- rTOP shall not be installed inside the 0,5 mT line.
Warnings
- The local operator needs to be trained on the controlled device. The local operator stays responsible for the safety of the patient (even if the controlled device is remotely controlled) and that the risk mitigations of the controlled device are still in place.
- The local operator needs to be trained on procedures, if remote control does not work.
- The local operator is responsible for the correct setup of the controlled device.
- Do not operate or install rTOP with open wounds on your hands or fingers.
- The physician has to make sure, that the use of rTOP (the remote control of the controlled device) is appropriate for the planned procedure.
- Do not sterilize rTOP.
- Do not use any other power supply than the one supplied with rTOP. Only use rTOP with the supplied 12 VDC LPS power supply.
- Do not open the housing of rTOP or any of it´s parts (webcam, power supply, …). Opening of the housing can result in electric shock. rTOP shall not be serviced or maintained by the user.
- Removal or replacement of a component can lead to malfunction of rTOP or electric shock. Maintenance and repairs can only be performed by the manufacturer or contracted service personnel.
- Do only connect the intended parts to the interfaces of rTOP.
- Before the use of rTOP, execute adequate verification, that the controlled device can be operated remotely. Make sure, that remote operation is not excluded in the intended use of the controlled device.
- Use rTOP only in hospital setting.
- Do not use rTOP, if the surrounding environment does not allow focussing.
- Do use rTOP only according to the Intended Use.
- The housing of rTOP can get hot. Do not touch the housing of rTOP.
- The use of rTOP can effect other medical devices and their accessories. rTOP shall be used no closer than 30 cm to any other medical device or their accessories.
- Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
- Do not touch the back side of the roclub Connector during normal use.
Electromagnetic Compatibility
rTOP has been tested according to applicable standards.
Only cables supplied with rTOP shall be used. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is no rmally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
rTOP is intended for use in the electromagnetic environment specified below. The customer or the user of the above listed models should assure that they are used in such an environment. See the following tables:
| Emissions test | Compliance | Electromagnetic environment - guidance |
|---|---|---|
| RF emissions | ||
| CISPR 11 | Group 1 | The above listed models use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RF emissions | ||
| CISPR 11 | Class A | The above listed models use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
Enclosure port
| Immunity test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment – guidance |
|---|---|---|---|
| Electrostatic discharge (ESD); IEC 61000-4-2 | ±8 kV Contact; ±2, ±4, ±8, ±15 kV Air | ±8 kV Contact; ±2, ±4, ±8, ±15 kV Air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Radiated RF EM fields and Proximity fields from RF wireless communications equipment; IEC 61000-4-3 | 3 V/m; 80 MHz – 2.7 GHz; 80% AM 1 kHz | 3 V/m; 80 MHz – 2.7 GHz | Mains power quality should be that of a professional healthcare facility environment. |
| 385 MHz (18 Hz Pulse Modulation) | 27 V/m | ||
| 450 MHz (FM ±5 kHz deviation 1 kHz sine or 18 Hz Pulse Modulation) | 28 V/m | ||
| 710 MHz (217 Hz PM) | 9 V/m | ||
| 745 MHz (217 Hz PM) | 9 V/m | ||
| 780 MHz (217 Hz PM) | 9 V/m | ||
| 810 MHz (18 Hz PM) | 28 V/m | ||
| 870 MHz (18 Hz PM) | 28 V/m | ||
| 930 MHz (18 Hz PM) | 28 V/m | ||
| 1720 MHz (217 Hz PM) | 28 V/m | ||
| 1845 MHz (217 Hz PM) | 28 V/m | ||
| 1970 MHz (217 Hz PM) | 28 V/m | ||
| 2450 MHz (217 Hz PM) | 28 V/m | ||
| 5240 MHz (217 Hz PM) | 9 V/m | ||
| 5500 MHz (217 Hz PM) | 9 V/m | ||
| 5785 MHz (217 Hz PM) | 9 V/m | ||
| RATED power frequency magnetic fields; IEC 61000-4-8 | 50 Hz or 60 Hz | 30 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
| Proximity magnetic fields; IEC 61000-4-39 | Test frequency: 134.2 kHz; PM 2.1 kHz | 65 A/m | Proximity magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
Input a.c. power port
| Immunity test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment – guidance |
|---|---|---|---|
| Electrical fast transient/bursts; IEC 61000-4-4 | ±2 kV; 100 kHz Repetition frequency | ±2 kV | Mains power quality should be that of a professional healthcare facility environment. |
| Surges; IEC 61000-4-5 | ±0.5 kV, ±1 kV line(s) to line(s); ±0.5 kV, ±1 kV, ±2 kV line(s) to ground (a) | ±1 kV Differential mode; ±2 kV Common mode | Mains power quality should be that of a professional healthcare facility environment. |
| Conducted RF induced by RF fields; IEC 61000-4-6 | 3 Vrms; 150 kHz – 80 MHz; 6 Vrms in ISM Radio Bands (c); 80% AM 1 kHz | 3 Vrms; 150 kHz – 80 MHz; 6 Vrms in ISM Radio Bands (c); 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines; IEC 61000-4-11 | % UT; 0°, 45°, 90°, 135°, 180°, 225°, 270°, 315°; 0% UT; 0°; 0% UT; 70%; 0% UT; 0%; 0.5 Cycles; 1 Cycle; 25/30 Cycles (50/60 Hz); 250/300 Cycles (50/60 Hz) (5s) | — | Mains power quality should be that of a professional healthcare facility environment. If the user of the above listed models requires continued operation during power mains interruptions, it is recommended that the above listed models are powered from an uninterruptible power supply or battery. |
Comment: a) Not applicable to CLASS II ME EQUIPMENT and ME SYSTEMS.
b) The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
Signal input/output parts PORT
| Immunity test | Test Condition | IEC 60601 Compliance level | Electromagnetic environment – guidance |
|---|---|---|---|
| Electrostatic discharge (ESD); IEC 61000-4-2 | ±8 kV Contact; ±2, ±4, ±8, ±15 kV Air | ±8 kV Contact; ±2, ±4, ±8, ±15 kV Air | Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical fast transient/bursts; IEC 61000-4-4 (a) | ±1 kV; 100 kHz Repetition frequency | ±1 kV | Mains power quality should be that of a professional healthcare facility environment. |
| Surges; IEC 61000-4-5 (b) | ±2 kV line(s) to ground | ±2 kV, Common mode | Mains power quality should be that of a professional healthcare facility environment. |
| Conducted RF induced by RF fields; IEC 61000-4-6 (a) | 3 Vrms; 150 kHz – 80 MHz; 6 Vrms in ISM Radio Bands (c); 80% AM 1 kHz | 3 Vrms; 150 kHz – 80 MHz; 6 Vrms in ISM Radio Bands (c); 80% AM 1 kHz | Mains power quality should be that of a professional healthcare facility environment. |
Electrical Safety
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
Use only with PSU provided by manufacturer.
Power supply unit
Mean Well GSM90A12-P1M
Input:
100-240 Vac; 50/60 Hz; 1,3-0,6 A
Output:
12 Vdc; 6,67 A; 80 W
rTOPdevice:
12 Vdc; 6,6 A
Intended Use
roclub TeleOperationPlatform (rTOP) is a system (software application and hardware component) intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device). It is a vendor neutral solution allowing read-only or full access control to connected devices. rTOP is also intended for training of medical personnel working on the medical imaging devices. Other medical devices, especially therapeutic devices (e.g. radiotherapeutic devices, …) with video and optional USB (Universal Serial Bus) interface for HID (Human Interface Device) may be used read only.
rTOP is not indicated for any specific disease, or condition.
rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Contraindications
rTOP is not indicated for any specific disease, or condition.
Intended User
To ensure safe use of rTOP, the device is intended for use by medical professionals.
Use Environment
rTOP is intended to be used in the hospital setting.
The temperature shall be between +15 °C to 40 °C.
The relative humidity shall be between 30 % r.H. and 70 % r.H.
The atmospheric pressure shall be between 54 kPa to 106 kPa.
User Training
Required user training involves reading the entirety of this User Manual and watching the rTOP Getting Started video prior to using the device.
Intended Patient Population
rTOP does not have a limitation concerning the patient population (e.g., age, weight, health, condition).
Maintenance/Cleaning
rTOP does not need maintenance by the user. Do not open the housing of rTOP. If during use of rTOP a problem becomes obvious to the user (e.g. cracked housing, cracks in the power supply, defect insulation on any cable, …) contact the manufacturer.
rTOP can be cleaned using a moist or dry fabric.
rTOP shall not be sterilised.
rTOP shall be at least monthly visual inspected. Contact the manufacturer, if visible cracks occur on the device or the power supply.
Installation instructions
Installation instructions are part of the scope of delivery or QR code.
In case they are missing, please contact support@roclub.com!
System Requirements
This chapter lists all hardware, software and network requirements for rTOP.
All requirements can be found on our knowledgebase: knowledgebase.roclub.io
Software Requirements
This SW requirements apply for the remote operator only:
| Parameter | Requirements |
|---|---|
| Web browser software | Chrome or Microsoft Edge internet browser in the up to date version. The browser needs to be installed on the PC, to be able to connect USB webcams and audio devices (not easily possible per remote desktop) |
| Operating system | up to date Windows (Win XP or newer) or Mac operating system |
| Network | 10/100/1000 Ethernet, and Wifi |
Hardware Requirements
This HW requirements apply for the remote operator only:
| Parameter | Requirements |
|---|---|
| PC | • Intel Core i5 processor or comparable |
| • min. 8 GB RAM | |
| Monitor | min 1920 x 1200 resolution |
| Peripherals | • 1x webcam |
| • 1x headset | |
| • 1x keyboard (compatible with OS of PC, connection via USB or wireless) | |
| • 1x mouse (compatible with OS of PC, connection via USB or wireless) |
Network Requirements
This chapter lists the requirements and recommendations for the network and configuration:
- It is recommended to operate rTOP in a separate subnet, which is fully disconnected from the clinical network for maximum security.
- It is recommended to use DHCP to allow allocation of a static IP to the connector. The reservation shall use the MAC-adress.
- DHCP shall be active for the first connection.
- As internet protocol IPv4 and IPv6 can be used. IPv6 can be deactivated, but dual-mode is recommended.
- rTOP needs a connection to the public internet with a recommended bandwith of min 20 MBit/s download (min 50 MBit/s for remote operator) and 10Mbit/s Upload.
- rTOP needs port 443 TCP and port 3478 UDP open in the firewall for outgoing connections (it can be necessary to open port 41641 UDP for some configurations).
- Incoming connections are not necessary. For security reasons it is recommended to only activate the MAC/IP address of rTOP.
General Notice
Including a software application, rTOP does not operate on its own and can only function in conjunction with computer hardware and software. The use of the application is restricted to the specific computer hardware and software outlined in the user documentation. The manufacturer provides the software device solely for its designated medical purpose, and the software and hardware itself is considered a medical device. Any other necessary components, hardware, or software required to ensure the workstation's functionality (e.g., operating systems, network structures, and displays) are not included. This also encompasses potentially required runtime dependencies, even if provided as part of the installation package for user convenience. However, the effects of such components on the medical device are considered and managed.
The capabilities and performance of the software device may be affected by limitations and failures of the hardware, network, or other installed software on the system. Therefore, proper operation and maintenance of the hardware and network are critical. It is necessary to adhere to the manufacturer's instructions concerning hardware and software specifications, as well as software maintenance.
Cybersecurity
Responsibilities
IT staff should be involved to ensure secure installation facilitated by roclub staff. Additionally, observed anomalies shall be reported by the user using the ticketing form or via informationsecurity@roclub.com.
Updates
Software and firmware updates are centrally managed and distributed by roclub. The installation of updates does not need user intervention. Updates are announced in the in-app banner.
Software Bill of Material
A software bill of material (SBOM) is available on the roclub knowledgebase under https://knowledgebase.roclub.io/en-en/privacy_and_security/sbom. Please note that only users authenticated with their roclub account may access this site.
In case you require the Software Bill of Material, but do not own a roclub account, please communicate to informationsecurity@roclub.com.
Ports and Networking
| Interface ID | Port or Interface | Label on device | Description | Incoming / Outgoing / Both | End Points |
|---|---|---|---|---|---|
| INT-01 | Port | Power | n/a | Incoming | Power socket |
| INT-02 | Port | LAN | Primary source of internet connectivity. | Both | LAN socket |
| INT-03 | Port | Video In | Video Signal; Transmission of the connected device’s video stream to the connector. | Incoming | Connected device |
| INT-04 | Port | Video Out | Video Signal; Transmission of the connected device’s video stream, originating from the connector’s in-built splitter, to the local operator’s display. | Outgoing | Local Operator Display |
| INT-05 | Port | OTG | USB C 3.0; Transmission of mouse and keyboard signals. | Outgoing | Connected device |
| INT-06 | Port | USB 1 | USB 3.0; Transmission of video signal of Camera 3 (additional camera) | Incoming | Camera 3 (additional camera) |
| INT-07 | Port | USB 2 | USB 3.0; Reserved for future use. | n/a | n/a |
| INT-08 | Port | USB 3 | USB 2.0; Transmission of video signal of Camera 1 (Operator Camera) | Incoming | USB 2.0; Transmission of video signal of Camera 1 (Operator Camera) |
| INT-09 | Port | USB 4 | USB 2.0; Transmission of video signal of Camera 2 (Scanner/Patient Camera) | Incoming | Camera 2 (Scanner/Patient Camera) |
| INT-10 | Port | USB 5 | USB 2.0; Transmission of audio signal to Conference Speaker | Outgoing | Conference Speaker |
| INT-11 | Port | USB 6 | USB 2.0; Reserved for future use. | n/a | n/a |
| INT-12 | Port | App Monitor | Video Signal; Reserved for future use (graphic card output from Jetson Orin) | n/a | n/a |
| INT-13 | Port | Talk-to-patient | Aux; Transmission of video conference audio. | Outgoing | Intercom |
| INT-14 | Interface | n/a | WiFi module; Reserved for future use. | n/a | n/a |
| INT-15 | Interface | n/a | Indication of KVM session status (connected, ready or offline) | Outgoing | n/a |
| INT-16 | Interface | On/Off | Turns the connector on or off. | Incoming | n/a |
| INT-17 | Interface | n/a | Touch Display; UI for the local user, Z40063-P12-ZC1 320x420. | Both | n/a |
| INT-18 | Interface | n/a | Factory reset (needle button); Resets the connector. | Incoming | n/a |
Backup and Restore
No patient data is stored, thus no backup necessary.
Responding to Cybersecurity Incidents
roclub employs a number of security mechanisms to detect vulnerabilities, anomalies and potential threats regarding the roclub Connector (rC) and the cloud backend.
When a cybersecurity event is detected, users will be informed by a roclub representative, following predefined information security event procedures. Additionally, a detailed report will be made available, outlining the nature of the event, the affected systems, and recommended actions to mitigate the threat. Users are encouraged to follow the provided guidelines to ensure the security and integrity of their systems.
A cybersecurity-specific communication channel has been instated at informationsecurity@roclub.com.
Logs
User actions and system events are logged for troubleshooting and auditing purposes. This includes user activities like joining or leaving a session, inviting participants etc. No video content or patient data is persisted.
End of Life
To deactivate an account, a user requests deactivation via the platform connected to the medical device. This request is synchronized through the established API to OpenFGA and Zitadel, which then deletes the user’s profile and permissions. User data will be managed according to the platform's data policies.
Do not throw rTOP or parts of it into residual waste. Please return them to roclub.
Back up mode
Per its design, the roclub connector does not possess an emergency or backup mode. Numerous control measures are in place to safeguard the confidentiality, integrity and availability of rTOP.
Safety and security risk management according to state of the art was executed and all control measures have been implemented.
Secure configuration
rTOP is delivered in a secure state with the latest software version installed. No configuration from the customer other than the management of user accounts is necessary which does not increase the security risk for the medical device.
Secure configuration include tamper-proof stickers on the hardware device, specific information about required endpoints for customer network hardening. Security event and logging parameters are centrally managed by roclub and leveraged, beneath other purposes, for anomaly detection.
Product Information
Account Creation
User accounts are created through the platform connected to the medical device. Once an account is created, the platform synchronizes the necessary details with the authorization model implemented in the medical device, ensuring that permissions and access rights are set up accordingly.
Software Installation
No installation is required, as the software is browser-based. However, for use within a secured network (e.g., in hospitals), whitelisting might be necessary. Please refer to the Installation Guide for detailed instructions.
Hardware Installation
For hardware installation procedures, please refer to the detailed steps outlined in the Installation Guide.
User Manual Access and Product Label
The latest version of the rTOP user manual can be accessed by clicking the “Help/Information” button in the menu.
The user manual includes the rTOP product label.
Account Deletion
When an account is deleted via the platform, the platform's system synchronizes this action with the authorization model in the medical device. This ensures the user's profile and associated permissions are removed, revoking all access rights.
Device Operating Instructions
Login
To begin using the device, the user must log in to the system by inputting their username and password. If using multi-factor authentication, the user follows the additional prompts.
Creating and Joining a Session
Creating a Session (Local Operator)
- Session Initiation: A session is always initiated by a local operator. To start a new session, the local operator selects the “Start Session” option.
- Session Components: Initially, a session consists of only the videoconferencing and chat functionalities. The local operator can communicate with other participants using these features. The connection to a medical device can only be established after the session has started.
- Inviting Participants: The local operator has the sole authority to add participants to the session. This is done through the Teams tab within the session interface:
- Navigate to the Teams tab and select “Add people”.
- Input the email addresses of the participants to invite them to join the session.
- Participants will receive an invitation via email, allowing them to join the session upon acceptance.
Joining a Session (Remote Operators)
- Waiting Room for Remote Operators: Remote operators who want to join an ongoing session will be directed to a waiting room. Upon attempting to join, they will remain in the waiting room until the local operator approves or denies their request.
- Approval Process: The local operator will receive a notification within the session interface whenever a remote operator attempts to join. The notification will offer the options to:
- Approve – The remote operator is accepted and will automatically join the session.
- Decline – The remote operator’s request is rejected, and they will remain unable to join the session.
Managing Participants
- Adding Participants: Only the local operator can add new participants to the session. To do so:
- Go to the Teams tab in the session interface and selects “Add people”.
- Enter the participant's email address and click "Invite."
- Removing Participants: At any time, the local operator can remove participants from the session. To remove a participant:
- Navigate to the Teams tab.
- Select the participant to be removed.
- Click “Remove” to immediately eject the participant from the session. If the remote operator is connected to a controlled device, the connection will end automatically.
Establishing a Connection to a Medical Device
Once participants have joined the session, the local or remote operator may proceed to establish a connection to a controlled medical device.
Videoconference
Accessing Videoconference Features
- Menu Bar Location: All videoconferencing controls are located in the menu bar at the bottom of the session interface. Participants can access various functions such as muting/unmuting, adjusting sound, and managing video. The status of the different functionalities is indicated with a green or red status dot within the button.
Muting and Unmuting
- Mute/Unmute Yourself: Participants can mute or unmute their microphone using the mute button in the menu bar. This allows them to control when they are heard by others in the session.
- Mute Other Participants: To mute another participant, the users can click on the three-dot menu and select Mute all participants.
Adjusting Sound Output
- Turning Off Sound: Participants can mute their own speaker output by clicking the speaker button in the menu bar. This will disable the sound from other participants, allowing them to focus on other tasks without hearing the conversation.
- Joint Mute/Speaker Control: In the area around the mute and speaker buttons, there is a joint button that allows participants to simultaneously mute their microphone and turn off their sound. This is useful if a participant needs to temporarily step away or silence both their input and output.
Managing the Camera
- Turning Camera On/Off: Participants can control their video feed by clicking the camera button in the menu bar. This allows them to turn their camera on or off at any point during the session.
Connecting to a Controlled Device
Establishing a Connection (Remote Operator)
- Only the remote operator has the ability to establish a connection to a controlled medical device. The local operator does not have access to the "Connect" button function.
- Starting the Connection:
- To connect, the remote operator clicks the "Connect" button to initiate the connection to the controlled medical device.
- A spinning wheel will appear on the interface, indicating that the system is in the process of establishing a secure connection with the selected device.
Connection Status Indicators
- Successful Connection: Once the connection has been successfully established, the "Connect" button will automatically switch to "Disconnect", indicating that the remote operator is now in control of the device. This change is visible to both the remote operator and the local operator in the session.
- The interface for the remote operator will change, showing the live stream of the controlled device. This view is only visible for the remote operator.
- Teams Tab: In the Teams tab, the local operator can visually track which remote participants are connected to a controlled device. The icon next to the name of any participant who is currently connected to a device will have a green circle, providing a quick visual indication of their connection status.
Ending a Connection
- Remote Operator Control: The remote operator can terminate their connection to the medical device at any time by clicking the "Disconnect" button. This will immediately end their control over the device.
-
Local Operator Authority: The local operator retains ultimate control over the session. At any point, the local operator can also forcibly terminate a connection established by a remote operator:
- Go to the Teams tab.
- Identify the participant who is connected to the device (green circle).
- Select their name and choose the option to "Disconnect" the participant.
This ensures that the local operator always maintains overall authority over the medical device, safeguarding against unintended or unauthorized operations.
Operating a Controlled Device
Live Stream of the Controlled Device
- Access to the Live Stream: After successfully connecting to the medical device, the remote operator will see a live stream of the device’s interface displayed within the session interface. This stream provides real-time visualization of the device’s output.
- Stream Duplication: The live stream is a direct duplication of the video signal from the controlled device. This ensures that the remote operator is seeing exactly what they would if physically present in front of the device.
Mouse and Keyboard Control
- Control Emulation: The remote operator can interact with the controlled device using their own mouse and keyboard. These inputs are emulated by the connector, meaning that the device responds to these actions as if they were being performed directly on-site.
- Full Device Control: The remote operator can perform any task or operation on the controlled device in the same way they would if they were physically present, including navigating menus, adjusting settings, or inputting commands.
Stream Settings Adjustment
The remote operator can modify the live stream settings to optimize their experience. To access these settings, click on the 3-dot-menu in the menu bar on the bottom of the screen. These settings include:
- Bitrate Adjustment: The bitrate of the stream can be adjusted to balance video quality with network performance, ensuring smooth operation even under varying bandwidth conditions.
- Mouse Settings:
- Absolute vs. Relative Mouse: The operator can toggle between absolute or relative mouse modes, depending on the specific input requirements of the controlled device.
- Reset HID (Human Interface Device): The operator can choose to reset the HID, which includes the mouse and keyboard, to restore default input settings if issues arise or if the inputs become unresponsive.
Talk-to-patient
Technical Setup
- Pre-Configuration: Before using the Talk-to-Patient feature, the system must be technically configured. This involves setting up the connection from the connector to the intercom system (if applicable).
- Local Operator Setup: The local operator must enable the Talk-to-Patient feature for the remote operator within the videoconference settings. Additionally, the local operator is responsible for setting the appropriate audio output for this feature, ensuring that the remote operator's voice is directed through the intercom.
Remote Operator Control
- Talk-to-Patient Icon: Once the feature is enabled, the remote operator will see a Talk-to-Patient icon in the bottom menu bar. This icon allows them to communicate directly with a patient through the intercom system.
- Using the Feature:
- Click and Hold: To speak to the patient, the remote operator clicks and holds the Talk-to-Patient button. This action directs their audio to the intercom system, allowing real-time communication with the patient.
- Release to Resume Default Output: Once the button is released, the remote operator’s audio will automatically revert to the default audio output of the local operator, ensuring normal communication within the session resumes.
Chat functionalities
Accessing the Chat
- Chat Tab: All participants in the session can access the chat feature by navigating to the Chat tab located in the side bar of the session interface.
Sending Messages
- Message Input: Participants can compose their messages in the text input field located within the Chat tab.
- Sending Messages: To send a message, participants can either press Enter on their keyboard or click the arrow button next to the input field. This action will transmit the message to all participants in the session.
Notification of New Messages
- New Message: If a new message is received while a participant is not actively viewing the chat, a red dot will appear on the Chat button in the side bar. This visual indicator alongside a acoustic signal alerts participants that there are unread messages waiting for them.
- Checking Messages: Participants can click on the Chat button to open the Chat tab and review the new messages. The red dot will disappear.
Chat Deletion on Session Exit
Automatic Deletion: Please note that all chat messages will be deleted when a participant leaves the session. This means that once a session ends or a participant exits, the chat history will no longer be available or recoverable.
Ending a session
Exiting for Remote Participants
- A remote participant can choose to exit the session by clicking the "Leave" button. This action will end only their participation and will not terminate the session itself.
- Connection Termination: If a remote operator is connected to a medical device when they exit the session, their connection to the device will be automatically ended. This ensures that no remote control persists after they leave.
- Reentering a Session: If a remote operator wishes to reenter a session that is still ongoing, they must go through the approval process by the local operator. They will be directed to the waiting room and must be approved again to rejoin.
Ending the Session (Local Operator)
- The local operator has the authority to end the entire session by clicking the "End Session" button.
- Termination of All Connections: When the local operator ends the session, all active connections to medical devices will be automatically terminated.
- Participant Removal: All participants, including the local operator and any remote operators, will be removed from the session. This ensures a complete closure of the session and its activities.
Messages
All system messages, error messages and fault messages are self-explanatory.
Troubleshooting
This section provides guidelines to help users identify and resolve basic issues that may arise while using rTOP. For common problems, please refer to the troubleshooting steps below.
For issues beyond basic troubleshooting or unresolved problems, users are encouraged to:
- Access additional resources in our Knowledge Base
- Submit a Support Ticket
- Contact us via email at support@roclub.com
| Problem | Cause | Solution |
|---|---|---|
| Unable to Log In | Wrong user credentials | Verify username and password, reset password if necessary. |
| Unable to Log In | No user credentials | Ensure your account has been created and activated via the platform. Contact support if needed. |
| Images or Results Fail to Load | Application is not connected to the internet | Check your internet connection and reconnect. If the issue persists, try refreshing the browser or application. |
| Application Crashes | System or application issue | Restart the application. If the problem continues, restart the computer. |
| Cannot Connect to Controlled Device | Device or network issue | Ensure the device is powered on and properly connected. Check network connection. Contact support if the issue persists. |
| Audio Issues in Videoconference | Microphone or speaker not configured | Check audio settings, ensure the correct microphone and speaker are selected, and verify they are not muted. |
| Any problem | N/A | Restart the application. |
Label
Glossary
Regulatory Symbols
Indicates the medical device manufacturer.
Indicates the manufacturer´s serial number so that a specific medical device can be identified.
Indicates the item is a medical device.
Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
Signifies European technical conformity.
Signifies Great Britain technical conformity.
Separate collection for electrical and electronic equipment (WEEE directive).
Indicates a carrier that contains Unique Device Identifier information.
Indicates the manufacturer´s bach code so that the batch or lot can be identified.
To warn of electricity.
Gives the temperature range for safe use of the medical device.
Gives the humidity range for safe use of the medical device.
Use only provided PSU with this device.
Terms and Definitions
| Term | Definition |
|---|---|
| CISPR | Comité international spécial des perturbations radioélectriques |
| HID | Human Interface Device |
| PC | Personal Computer |
| rC | roclub Connector |
| rTOP | roclub TeleOperationPlattform |
| USB | Universal Serial Bus |
Customer Support/Contact
If you have any questions, problems, or comments regarding rTOP functionalities or this user manual, please contact the customer support team:
support@roclub.com