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MediView Regulatory Information

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MediView XR, Inc.

Global Cardiovascular Innovation Center, 10000 Cedar Ave.

STE# GCIC2-153

Cleveland, Ohio, US, 44106

Device Trade Name: OMNIFYXR

Safety Information

This section outlines important health and safety information regarding the use of the OmnifyXR system. Please read and understand the information provided in this section.

WARNINGS

  • Read safety and health information. This section is intended to assist you in understanding the associated risks and proper ways to use and care for your system. Failure to understand the risks associated with using the OmnifyXR system may result in undesired circumstances, such as personal injury, property damage, or death.

CAUTIONS

  • To decrease the risk of possible irritation, clean the HoloLens 2 regularly.
  • Refrain from using lotions or other skin products where the HoloLens 2 contacts your skin.
  • Do not wear the HoloLens 2 over any injured skin (e.g., burns, scrapes, rash, open wounds).
  • If your skin becomes irritated as a result of wearing the HoloLens 2, stop using it immediately and contact your MediView representative.

Materials and Biocompatibility

Proceduralists should be aware of any adverse reactions on the skin where the device (Microsoft HoloLens 2) has contact, such as redness (erythema), swelling (edema), irritation, sensitization (delayed Type IV hypersensitivity), allergy, immune response, or other reactions. Contact your MediView representative to report any biocompatibility issues.

If applicable to the procedure, a user may wear a surgical cap underneath the Microsoft HoloLens 2 to prevent the spread of disease or other microbes.

Electrical Safety & EMC Compliance

Please review the following warnings to avoid any adverse events related to electrical safety.

WARNINGS

  • It is important to handle the battery of the Microsoft HoloLens 2 properly. Any improper use, including but not limited to, exposing it to heat, opening, puncturing, mutilating, or disposing of it in fire, can cause a fire or explosion.
  • To avoid burns, fire, or damage to the headset, only charge the Microsoft HoloLens 2 with the appropriate AC power supply. The Microsoft HoloLens 2 provided with your OmnifyXR system includes a legitimate Microsoft power supply unit and AC power cord.
  • Improper handling, storage, or charging of the HoloLens 2 battery, such as direct sunlight exposure for an extended period of time, may result in fire or explosion.
  • To avoid electric shock, OmnifyXR must only be connected to power supply mains with protective earth.
  • The power supply for the MediView Streamer shall be checked periodically to ensure functionality.
  • Do not plug the MediView Streamer or HoloLens 2 into power supply mains. Do not connect the MediView Streamer or HoloLens 2 into multiple socket outlets. The Streamer and headsets must be powered by the provided (medical-grade isolated) power supply.
  • Do not use the HoloLens 2 while it is plugged in and charging. The device should only be used on battery power and charged between uses.
  • Opening and/or self-repairing any electrical equipment included in the OmnifyXR system including, but not limited to, the Microsoft HoloLens 2, MediView Streamer, or MediView Router has the risk of electric shock, personal injury, fire, damage to the components, and other hazards. Please reach out to MediView for support if your system is in need of repair.
  • The OmnifyXR system emits radiofrequency or magnetic fields during use. While this system is tested for safety and complies with applicable EMC standards, operation of other electronic equipment or medical devices affected by radiofrequency or magnetic fields may cause them to malfunction unintentionally.
  • Any user with a pacemaker or similar personal medical device must be aware of relevant risks should their device be interrupted or malfunction as a result of using the OmnifyXR system, which may include personal injury or death. Please understand the following precautions to avoid risk:
    • The American Heart Association recommends maintaining a minimum separation of 15 cm (6 inches) between a wireless device (such as the Microsoft HoloLens 2) and a pacemaker.
    • If you believe that use of the OmnifyXR system is causing interference with your personal medical device, immediately turn off the system.
    • For other personal medical devices, contact your physician or device manufacturer for additional guidance regarding potential interference from other electronic devices.
  • In the event that EMC interference occurs, the user may experience increased system response time, failure to respond to user input, or failure to power on. Refer to the standard-of-care imaging display and contact your MediView representative.
  • To prevent wireless interference, OmnifyXR must be kept >17 meters away from LTE transmitters in 5GHz band. For example, this would include equipment used by telecom providers. This equipment would typically be mounted on a cellular tower but may be located within a facility to provide additional coverage within a building. Please check with the building planner to ensure the MediView Router and HoloLens 2 are located at an acceptable distance.
  • In accordance with ANSI C63.27-2017, any unintentional source transmitting at 2437 MHz (2.4 GHz) must be at least 1.6 meters away from the MediView Router or HoloLens 2 in order to not interfere with transmission of the video streams.

In accordance with ANSI C63.27-2017, any unintentional source transmitting in the 5150-5850 MHz (5 GHz) range must be at least 0.575 meters away from the MediView Router or HoloLens 2 in order to not interfere with transmission of the video streams.

CAUTION

  • 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 normally 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

System Usage

Please review the following warnings to avoid any adverse events related to use of the system.

WARNINGS

  • Virtual objects may be accidentally placed or moved out of view. If the desired virtual object cannot be located, use the voice command “Gather all” to relocate all video segments back into view. If the 3D Model still cannot be located, use the voice command “Show model.”
  • When transitioning between rooms or spaces, the headset will automatically attempt to detect the new environment. Performance may be degraded during this time but will be restored when the space detection is complete.
  • Musculoskeletal disorders. Prolonged use of the OmnifyXR system may cause the user to experience discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness. To help avoid these issues, use OmnifyXR in a comfortable bodily position, keep your neck and head straight while wearing the Microsoft HoloLens 2, and take breaks often. If any of these problems persist, see a medical professional right away.
  • Any user with a pre-existing vision disorder, such as stereo blindness or other binocular vision disorder, may be unable to view the 3D stereoscopic content of the Microsoft HoloLens 2 head-mounted display. Such individuals should not use the OmnifyXR system and must consult an eye doctor prior to use. The HoloLens 2 may be used with eyeglasses or contact lenses.
  • When not in use, store the Microsoft HoloLens 2 in the provided storage cases. Improper storage of the Microsoft HoloLens 2 between procedures, such as placing it on an uneven or unstable surface, may result in damage to the device or personal injury.
  • Store cables in a properly arranged manner. Improper cable management may lead to tripping or temporary injury, as well as damage to the system.
  • Excessive application load may lead to overheating of the Microsoft HoloLens 2. If this occurs, power down the headset and wait for the headset to cool before resuming the use of OmnifyXR.
  • Overheating of the Microsoft HoloLens 2 may cause discomfort due to heat. If this occurs, immediately power down and remove the headset.
  • Headset fit. Poor or loose Microsoft HoloLens 2 fit may lead to the headset falling off of a user during a procedure. This may potentially lead to a delay in procedure or a breach of the sterile field and can cause patient infection. To ensure proper headset fit, please see the Microsoft documentation for more information.
  • Headset fit. Mechanical failure of the Microsoft HoloLens 2 mount or restraint may cause a headset to fall off of a user’s head during use, which may cause a delay in procedure or a breach of sterile field. To prevent mechanical failure, always use proper care when handling or storing the headset.

Disinfection and Sanitization

The OmnifyXR system requires routine cleaning, which includes the removal of dirt from the external surfaces such as the MediView Router, Streamer, and HoloLens 2. Clean with 70% medical-grade alcohol using a dampened soft towel or wipe. Clean until no debris is visible upon inspection.

CAUTIONS

  • Only clean the exterior of the HoloLens 2.
  • Do not insert objects into the openings on the HoloLens 2, including the fan, vents, or ports.
  • Do not expose the OmnifyXR system to sprays, liquids, or other solvents.
  • To avoid damage to the OmnifyXR system, avoid liquid spillage while cleaning.
  • Be sure to power off and disconnect the AC power cord before performing cleaning.

General Safety Instructions

WARNINGS

  • Read the entirety of the user manual before operating the OmnifyXR system. All instructions and guidelines must be followed to maintain patient and operator safety.
  • Use this system ONLY for indicated uses outlined within the user manual.
  • Use of the OmnifyXR system should NOT interfere with the standard of care for procedures within the indications for use. OmnifyXR is not intended to be the sole visualization tool for any procedure.
  • Please follow the instructions in the user manual each and every time the system is prepared and utilized.
  • Please maintain general safety precautions before, during, and after the procedure.
  • Follow the guidelines for disinfecting and sanitizing all components of the OmnifyXR device (including the Microsoft HoloLens 2) to prevent the spread of infection or contagious disease to operators and patients.

CAUTIONS

  • Devices should be stored in a designated, limited-access area that is well-ventilated and provides protection from dust, moisture, and temperature/humidity extremes.
  • Please contact MediView if the OmnifyXR system is not working properly; it may need service or replacement.
  • All servicing and repairs should be performed by authorized MediView personnel. Do not attempt to service the system yourself (doing so may violate the conditions of a service agreement and/or warranty). Further, do not change or remove any components of the OmnifyXR system. Doing so may also result in a voided warranty. Please refer to your warranty for more details.
  • Please reference your service contract for periodic maintenance on your OmnifyXR system by an authorized MediView representative.

For customers in the EU: Any serious incident that has occurred in relation to the device should be reported to MediView and the competent authority of the Member State in which the user and/or patient is established.

The device is designed for operation between 10-35ºC.

Disposal of Waste Batteries and Electrical & Electronic Equipment

 

 

 

 

This symbol on the product or its batteries or its packaging means that this product and any batteries it contains must not be disposed of with typical waste. Instead, it is your responsibility to hand this over to an applicable collection point for the recycling of batteries and electrical and electronic equipment. This separate collection and recycling will help to conserve natural resources and prevent potential negative consequences for human health and the environment due to the possible presence of hazardous substances in batteries and electrical and electronic equipment, which could be caused by inappropriate disposal. For more information about where to drop off your batteries and electrical and electronic waste, please contact your local city/municipality office, your household waste disposal service, or your MediView representative. Rechargeable products contain a Lithium-ion Battery.

For customers in the EEA:

The radio frequency bands of operation for Microsoft HoloLens 2 (Model 1855) and the associated maximum nominal transmit power and tolerances are as follows:

WLAN 2400-2483.5MHz, 18.30dBm EIRP +/-1dB

WLAN 5.15-5.25GHz, 21.20dBm EIRP +/-1dB

WLAN 5.25-5.35GHz, 18.50dBm EIRP +/-1dB

WLAN 5.47-5.725GHz, 18.60dBm EIRP +/-1dB

WLAN 5.725-5.85GHz, 12.7dBm EIRP +/-1dB

Bluetooth 2400-2483.5MHz, 14.9dBm EIRP +/-2dB

The MediView Router (GL Technologies (Hong Kong) Limited) uses WiFi 2.4GHz Operating Frequency, 2400~2483.5MHz/20dBm; 5GHz Operating Frequency is 5150~5250MHz/23dBm.

The wireless module used in the MediView Streamer (OnLogic, Inc.) is the Intel® Wireless-AC 9260. The radio frequency bands of operation and maximum power output for the Intel® Wireless-AC 9260 are as follows:

IEEE802.11 b/g/n mode Bluetooth 2400-2483.5MHz, 20dBm EIRP max (100mW)

BLE 2400-2483.5MHz, 10dBm EIRP max (10mW)

IEEE802.11 a/n/ac mode 5150-5725MHz, 23 dBm EIRP max (200mW), the low band 5.15-5.35GHz is for indoor use only

IEEE802.11 a/n/ac mode 5725-5875MHz, 13.98 dBm EIRP Max (25mW), for the standard EN 300 440, the device operating in 5.8 GHz is considered a category 2 receiver

5.15-5.25GHz is allocated for indoor use only.

Authorized Representative under the Medical Device Regulation (EU) 2017/745:

CEpartner4U BV

Esdoornlaan 13

3951 DB Maarn

The Netherlands

Ph: +31 6 516 536 26

Fax: +31 343 442 162

Simplified EU Declaration of Conformity:

MediView XR, Inc. declares that the OmnifyXR product (OXR-SYS) is in compliance with Directive 2014/53/EU.

The full text of the EU Declaration of Conformity is available at the following internet address: TBD

Full Declaration of Conformity also contains information such as Software and Accessories that may impact radio compliance with the above directive.

Additional regulatory information on the Microsoft HoloLens 2 device is available on the Microsoft Corporation website. The EU Declaration of Conformity for the Microsoft HoloLens 2, MediView Router (GL Technologies (Hong Kong) Limited), and MediView Streamer (OnLogic, Inc.) are available on the website of each manufacturer.

Device Identification:

  • Part Number: The part number for OmnifyXR is OXR-SYS.
  • Unique Device Identifier: Upon contacting MediView for service, you may be asked to provide your device’s UDI number. To identify this number, locate the MediView Streamer, flip it over, and locate the UDI code on the label, located next to the “UDI” symbol.

General Data Protection Regulation (GDPR) – European Representative

Pursuant to Article 27 of the General Data Protection Regulation (GDPR), MediView XR has appointed European Data Protection Office (EDPO) as its GDPR Representative in the EU. You can contact EDPO regarding matters pertaining to the GDPR:

  1. By using EDPO’s online request form: https://edpo.com/gdpr-data-request/
  2. By writing to EDPO at Avenue Huart Hamoir 71, 1030 Brussels, Belgium

For customers in the United States:

The OmnifyXR system is FDA-registered as a Class I device in the U.S.