XRHealth – Warning and Precautions

XRHealth – Health and Safety Warnings and Precautions
To reduce the risk of personal injury, discomfort or property damage, please ensure that you read the health and safety warnings and precautions below carefully before using the XRHealth Products.

Capitalized terms not defined herein shall, unless otherwise indicated herein, have the meanings ascribed to such terms in the XRHealth – Terms of Use.

  • Read and follow all setup and operating instructions provided with the VR headset, including all hardware and software recommendations. 
  • The XRHealth Products are not designed for use with any unauthorized device, accessory, software or content. Use of any unauthorized device, accessory, software or content, or hacking the device, software or content may result in injury to you or others, may cause performance issues or damage to your XRHealth Product.
  • The XRHealth Product is designed and intended to be used in an open and safe indoor area, free of any tripping or slipping hazards. Always be aware of your surroundings before beginning use and while using the XRHealth Products. Use caution to avoid injury.
  • Always consult with your doctor before using the XRHealth Products.
  • The XRHealth Products are not medical devices, and are not intended to diagnose, treat, cure, or prevent any disease.

A10tion AT-910 – Intended Use, Precautions and Contraindications

A10tion AT-910 – Intended Use, Precautions and Contraindications

The AT-910 (“A10tion”) is a is a virtual reality, immersive therapeutic application, indicated to train and improve cognitive function of patients with diagnosed ADHD.” A10tion” is a clinician- monitored program and should be considered for use as part of the therapeutic program that include cliniciandirected therapy. Standard clinical means of care should be maintained (e.g medications).

AT-910 is not intended to be used for diagnosis, treatment, decision making, or as a stand- alone device.

Intended user populations

AT-910 software is intended to be used by the following populations

Software operators

Licensed Health Care Providers (i.e. Physical therapists, Physicians, Psychologists, Caregivers, Geriatricians etc.) and/or patients, that utilize physical activity as part of conventional treatment..

End users

Individuals with ADHD with attention, inhibition or working memory deficits.

Intended use environment: 

AT-910 software is intended to be used only in the following environments or areas:

  • Healthcare facilities;
  • Home environment;

Contraindications:

Before using the “A10iton” software, the Health Care Provider (and/or the end user) shall make sure that they do not suffer from one or more of the following conditions:

  1. Tumors or other space occupying lesion (SOL) of the cervical region;
  2. Undiagnosed neurological symptoms/signs;
  3. Acute fracture of the cervical spine (especially fracture of odontoid process (Dens));
  4. Pathological fractures of the spine;
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised;
  6. Any condition where it is otherwise contraindicated to move cervical region actively or passively;
  7. Contagious or infectious conditions (while multiple users use same headset);
  8. Any condition where it is otherwise contraindicated to move shoulder and/or arm and/or wrist’s anatomical structures actively or passively;
  9. Any recent unexplained loss of consciousness.
  10. Seizures or taking antiepileptic medications.
  11. Any severe mental health disorder not already under the care of a clinician, such as psychotic, affective mood, stress or anxiety disorders.
  12. Any acute/chronic condition causing tiredness, dizziness, nausea or vertigo.
  13. Being under the influence of alcohol or recreational drugs;

Additional Precautions:

    1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute/chronic condition; If the user feels any discomfort, they should terminate the session immediately.
    2. Upper limb (shoulder, arm and wrist) movements may exacerbate any pre-existing pain or discomfort. If the user feels any excessive pain or discomfort, they should terminate the session immediately.
    3. Some users with existing vertigo or nausea may experience an exacerbation of these symptoms in VR environment; If the user feels any discomfort, they should terminate the session immediately.
    4. Vision disorders – users requiring glasses that do not fit under the VR headset or have other major visual abnormalities may not be able to use the software appropriately. Health Care Provider discretion is advised.
    1. Weak neck muscles/Acute neck pain – patients with weak neck muscles or irritable suffering from acute neck pain may experience difficulties carrying the weight of the VR headset. Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware weight.
    2. Heart conditions – CHF (Congestive Heart Failure) or other conditions that limit aerobic capacity, requiring adapting the training to suitable pace to prevent an excessive aerobic requirement. This may require the Health Care Provider to use a third-party monitoring device (such as heart rate monitor) to ensure patient safety or instruct patient to limit game speed to a comfortable pace.
    3. If the user has a defibrillator, pacemaker, hearing aid or any other implanted medical device, he should not use the VR hardware without first consulting his physician or the manufacturer of the medical device as the VR hardware may interfere with its proper function.
    4. Balance disorders – as VR experience is immersive, Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware if the patient has any pre-existing disorder affecting balance (e.g. Parkinson’s disease, multiple sclerosis, dementia). patients showing any balance associated symptoms should be supervised closely. For some balance disorders the patient might require protective harness and/or belt for support.
    5. Contagious conditions – in order to avoid transferring of contagious conditions (like pink eye), the VR headset should not be shared with users with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp.
    6. Health Care Providers are advised to use their clinical judgement before exposing the patient to VR hardware if he is taking medications which may provoke seizures or impair his vision or balance.

Warnings and General Limitations: 

  1. All warnings and general limitations related to the safe use of the VR hardware console (recommended for use with VRCBT software) are applicable when used with VRCBT AT-910 software.
  1. Prior the usage of the commercial “off-the-shelf” VR hardware, it is required from the user and the health care provider to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. It is the Health Care Provider’s responsibility to confirm that it is safe and continues to besafe for a specific patient to use the Virtual Reality Hardware (VRH) before using the A T-910.
  2. XRHealth IL ltd shall not be held responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the abovementioned hardware.
  3. Each VR training session using VRPhysio Home series software shall not last longerthan the continuous duration as recommended by the hardware manufacturer.
  4. If the user is experiencing symptoms associated with loss of consciousness, involuntary movements/seizures, visual abnormalities, tiredness, dizziness, vertigo, nausea, digestive problems, emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches or any physical or emotional pain or discomfort,the training session must be terminated immediately.

Possible Side effects

In our experience, There are no serious adverse events. a list of possible risks factors and preventive acts are listed as followed:

  1. Tasks are not challenging enough, leading to a partial treatment goals and possible lack of compliance: Patient is guided to follow the clinician training plan.
  2. Tasks are too difficult , leading to frustration, lack of compliance and to a risk of injury :every task went through verification and validation to make sure it meets all requirements. Patient is guided to follow the clinician training plan. Last but most importantly, If the user experiences any pain or discomfort, he is instructed to immediately discontinue the session and notify his clinician.
  3. uncomfortable virtual reality experience (VR sickness), characterised by blurred, double vision or other visual abnormalities, dizziness, disorientation, impaired balance or nausea. Clinicians are instructed to read about the VR Device limitations prior to prescribing the VR Device to their patients. All commercial off-the-shelf VR Devices limitations are valid. Users are instructed to immediately discontinue the session in case of nausea, dizziness or vertigo. If the user experiences any of these symptoms, he is instructed to immediately discontinue the session.
  1. Vision aids (glasses) does not fit under the VR headset, leading blurry vision,transient headache or any other visual discomfort: Clinicians will be instructed to facilitate clinical judgment while fitting the VR Device over patients’visual aids (some patients may require replacing their glasses with contact lenses to be able to use the software). If the patient experiences any of these symptoms, he will be instructed to immediately discontinue the session.
  2. Inadequate Vision- Using the software while the VR headset is not properly fit, possibly causing blurry vision, transient headache or any other visual discomfort: 1. The patient is instructed to follow the VR hardware’s manual.
  3. Loss of balance during the usage of the software , possibly leading to an injury:
    1. Clinicians should thoroughly evaluate the patient’s functional status and assign a treatment plan most suitable for the patient’s functional ability, level of impairment and diagnosis.
    2. Clinician and patient should read thoroughly the specific VR hardware’s safety and warnings instructing the user how to avoid injury by correctly setting up the training area.
  4. Inadequate training location-The patient may train in an unsafe training area(including loud noises, external distractions and physical obstacles), leading to a possible injury:
    1.Clinician and patient should read thoroughly the specific VR hardware’s safety and warnings instructing the user how to avoid injury by correctly setting up the training area.
  5. VR Hardware’s Controllers – dropping hand held remote, possibly leading to an injury :

Clinicians and patients should read off-the-shelf VR manufacturer safety instructions guiding users to safely secure hand-held remotes using the remote’s original straps/cables.

  1. Unapproved VR hardware -User attempts to use the software on another (i.e. not tested and approved) type of VR headset, possible causing software malfunctions. 1. clinician should make sure that the patient installs the software only on approvedVR headsets.
  2. User errors- Patient fails to follow instructions, possibly leading to an injury, Poorachievement of treatment goals or decreasing engagement. 1.The clinician should follow-up on patient’s engagement and performance.
    2.The patient is instructed to terminate the training if he feels any pain/discomfort.
  3. Inadequate training program, possibly leading to an injury:1.Clinicians are instructed to thoroughly evaluate the patient’s medical conditionand history, and make sure that they are aware of all contraindications andprecautions for the usage of the device before setting up the proper trainingprogram.2.The patient should follow the clinician training program.
  4. Excessive Use, Overuse of the software, not according to the prescribed treatmentplan. possibly causing: VR sickness, behavioural abnormalities, low frustration level, increased impulsivity:
    1. The patient should to follow the clinician training plan.
    2. Patient and caregiver are instructed to follow the VR Hardware Health & SafetyWarnings.
    3.If the patient experiences any physical discomfort, he will be instructed to immediately discontinue the session.
    4.Caregivers will be instructed to follow-up on patient’s behavioral abnormalities and/or physical discomfort and will be instructed to immediately discontinue the session and notify the patient’s clinician.

Mindset PD-810 – Intended Use, Precautions and Contraindications

Mindset PD-810 – Intended Use, Precautions and Contraindications

The PD-810 (“Mindset”) is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The PD-810 is a nonprescription device that can be used in clinical setting or at home, with or without the assistance of clinician. The PD-810 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. PD-810 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment. 

End users

Individuals that will benefit from using VRReliever series for relaxation and self-management of pain and physical discomfort. 

Intended use environment: 

Mindset software is intended to be used only in the following environments or areas: 

  • Home environment; 
  • Healthcare facilities; 

Contraindications:

Before using the Mindset software, the user must be sure that they do not suffer from one or more of the following conditions:  

  1. Tumors or other Space Occupying Lesion of cervical region; 
  2. Undiagnosed neurological symptoms/signs; 
  3. Acute fracture of the cervical spine (especially fracture of Odontoid Process (Dens));
  4. Pathological fractures of spine; 
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised; 
  6. Contagious or infectious conditions (while multiple users use same headset); 
  7. Facial lesions or superficial lesions that may have contact with the VR headset; 
  8. Any condition where it is otherwise contraindicated to move cervical region actively or passively; 
  9. Epileptic seizures; 
  10. Any severe mental health disorder not already under the care of a clinician, such as dissociative disorders, psychotic disorders, or severe depressive, trauma or anxiety disorder

Additional Precautions:

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute condition; If user feels any discomfort, they should terminate session immediately. 
  2. Some users with existing Vertigo or Nausea may experience exacerbation of the symptoms in VR environment; If user feels any discomfort, they should terminate session immediately. 
  3. Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately.  
  4. Acute neck pain – users suffering from acute neck pain may experience difficulties carrying the weight of the VR headset.  
  5. Consult with your physician before using the software if you have pre-existing vision abnormalities, neck pain or spine abnormalities, psychiatric disorders, suffer from a heart condition or other serious medical condition. 
  6. If you have a pacemaker or other implanted medical device, do not use the VR Hardware without first consulting your doctor or the manufacturer of your medical device. 
  7. Although the VRReliever Software is based on techniques and imagery that most users find relaxing, there is a chance that some of the imagery users encounter may evoke unintended anxious feelings based on personal associations. Also, at times the guided relaxation exercises will ask users to notice and be with their feelings, which can sometimes evoke distress in some users. Please consult with your physician or mental health clinician before using the software if you have pre-existing mental health diagnoses

Warnings and General Limitations: 

  1. Warning and general limitations related to the safe use of the Virtual Reality Hardware console (recommended for use with VRReliever software series) are applicable when used with VRReliever PD-810 software. 
  2. Prior the usage of the commercial “off-the-shelf” Virtual Reality Hardware, it is required from the user to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. 
  3. XRHealth IL LTD is not responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware. 
  4. Each VR training session using VRReliever series software shall not last longer than the continuous duration recommended by the hardware manufacturer.   
  5. If user is experiencing symptoms associated with: tiredness; being under the influence of alcohol or drugs; digestive problems; emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches the training session must be terminated immediately

Color Match MC-320 – Intended Use, Precautions and Contraindications

Color Match MC-320 – Intended Use, Precautions and Contraindications

The MC-320 (“Color Match”) is a physical medicine and motor-cognitive rehabilitation software, as a medical device, intended for use in upper extremity, full body and motor-cognitive conventional rehabilitation. The software enables:

  • Tracking motion and movement kinematics.
  • Guiding patients in the performance of motor-cognitive exercises according to the treating medical practitioner’s guidelines.
  • Monitoring changes in patient’s measurements over time

MC-320 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.

MC-320 software is intended to be used by the following populations:

Software operators

Licensed Health Care Providers (i.e. Physical therapists, Physicians, Psychologists, Caregivers, Geriatricians etc.) and/or patients, that utilize physical activity as part of conventional treatment.

End users

Individuals that will benefit from using MC-320 to support the performance of their prescribed motor-cognitive exercises as part of their conventional rehabilitation.

Intended use environment:

MC-320 software is intended to be used only in the following environments or areas:

  • Physical medicine hospital units;
  • Physical therapy clinics;
  • Any other facility that utilizes physical activity treatment;
  • Home environment;

Contraindications:

Before using the Color Match software, the Health Care Provider (and/or the end user) shall make sure that they do not suffer from one or more of the following conditions:

  1. Tumors or other space occupying lesion (SOL) of the cervical region;
  2. Undiagnosed neurological symptoms/signs;
  3. Acute fracture of the cervical spine (especially fracture of odontoid process (Dens));
  4. Pathological fractures of the spine;
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised;
  6. Any condition where it is otherwise contraindicated to move cervical region actively or passively;
  7. Any condition where it is otherwise contraindicated to move shoulder and/or arm and/or wrist’s anatomical structures actively or passively;
  8. Any recent unexplained loss of consciousness.
  9. Seizures or taking antiepileptic medications.
  10. Any severe mental health disorder not already under the care of a clinician, such as psychotic, affective mood, stress or anxiety disorders.
  11. Any acute/chronic condition causing tiredness, dizziness, nausea or vertigo.
  12. Being under the influence of alcohol or recreational drugs;

Additional Precautions:

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute/chronic condition; If the user feels any discomfort, they should terminate the session immediately.
  2. Upper limb (shoulder, arm and wrist) movements may exacerbate any pre-existing pain or discomfort. If the user feels any excessive pain or discomfort, they should terminate the session immediately.
  3. Some users with existing vertigo or nausea may experience an exacerbation of these symptoms in VR environment; If the user feels any discomfort, they should terminate the session immediately.
  4. Vision disorders – users requiring glasses that do not fit under the VR headset or have other major visual abnormalities may not be able to use the software appropriately. Health Care Provider discretion is advised.
  5. Weak neck muscles/Acute neck pain – patients with weak neck muscles or irritable suffering from acute neck pain may experience difficulties carrying the weight of the VR headset. Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware weight.
  6. Heart conditions – CHF (Congestive Heart Failure) or other conditions that limit aerobic capacity, requiring adapting the training to suitable pace to prevent an excessive aerobic requirement. This may require the Health Care Provider to use a third-party monitoring device (such as heart rate monitor) to ensure patient safety or instruct patient to limit game speed to a comfortable pace.
  7. If the user has a defibrillator, pacemaker, hearing aid or any other implanted medical device, he should not use the VR hardware without first consulting his physician or the manufacturer of the medical device as the VR hardware may interfere with its proper function.
  8. Balance disorders – as VR experience is immersive, Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware if the patient has any pre-existing disorder affecting balance (e.g. Parkinson’s disease, multiple sclerosis, dementia). patients showing any balance associated symptoms should be supervised closely. For some balance disorders the patient might require protective harness and/or belt for support.
  9. Contagious conditions – in order to avoid transferring of contagious conditions (like pink eye), the VR headset should not be shared with users with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp.
  10. Health Care Providers are advised to use their clinical judgement before exposing the patient to VR hardware if he is taking medications which may provoke seizures or impair his vision or balance.

Warnings and General Limitations: 

  1. All warnings and general limitations related to the safe use of the VR hardware console (recommended for use with VRPhysio Home software series) are applicable when used with VRPhysio Home MC-320 software.
  2. Prior the usage of the commercial “off-the-shelf” VR hardware, it is required from the user and the health care provider to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. It is the Health Care Provider’s responsibility to confirm that it is safe and continues to be safe for a specific patient to use the Virtual Reality Hardware (VRH) before using the MC-320.
  3. VRHealth ltd shall not be held responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware.
  4. Each VR training session using VRPhysio Home series software shall not last longer than the continuous duration as recommended by the hardware manufacturer.  
  5. If the user is experiencing symptoms associated with loss of consciousness, involuntary movements/seizures, visual abnormalities, tiredness, dizziness, vertigo, nausea, digestive problems, emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches or any physical or emotional pain or discomfort, the training session must be terminated immediately.

Relax8 MD-710 – Intended Use, Precautions and Contraindications

Relax8 – MD-710 – Intended Use, Precautions and Contraindications

Intended use The MD-710 (“Relax8”) is intended to assist in relaxation and self-management of pain and physical discomfort through distraction and supporting meditation and relaxation exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The MD-710is a nonprescription device that can be used in clinical setting or at home, with or without the assistance of clinician. The MD-710 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. MD-710 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.Relax8 software is intended to be used by the following populations:

End users 

Individuals that will benefit from using VRReliever series for relaxation and self-management ofpain and physical discomfort.

Intended use environment:  

Relax8 software is intended to be used only in the following environments or areas:

  • Home environment;
  • Healthcare facilities;

Contraindications:

Before using the Relax8 software, the user must be sure that they do not suffer from one or more of the following conditions:

  1. Tumors or other Space Occupying Lesion of cervical region;
  2. Undiagnosed neurological symptoms/signs;
  3. Acute fracture of the cervical spine (especially fracture of Odontoid Process (Dens));
  4. Pathological fractures of spine;
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised;
  6. Contagious or infectious conditions (while multiple users use same headset);
  7. 7.Facial lesions or superficial lesions that may have contact with the VR headset;
  8. 8.Any condition where it is otherwise contraindicated to move cervical region actively or passively;
  9. Epileptic seizures;
  10. For breathing module only –do not use if you suffer from Active Asthma, Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure.
  11. Any severe mental health disorder not already under the care of a clinician, such as dissociative disorders, psychotic disorders, or severe depressive, trauma or anxiety disorders.

Additional Precautions:

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute condition; If user feels any discomfort, they should terminate session immediately.
  2. Some users with existing Vertigo or Nausea may experience exacerbation of the symptoms in VR environment; If user feels any discomfort, they should terminate session immediately.
  3. Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately.
  4. Acute neck pain – users suffering from acute neck pain may experience difficulties carrying the weight of the VR headset.
  5. Consult with your physician before using the software if you have pre-existing vision abnormalities, neck pain or spine abnormalities, psychiatric disorders, suffer from a heart condition or other serious medical condition.
  6. If you have a pacemaker or other implanted medical device, do not use the VR Hardware without first consulting your doctor or the manufacturer of your medical device.
  7. Although the VRReliever Software is based on techniques and imagery that most users find relaxing, there is a chance that some of the imagery users encounter may evoke unintended anxious feelings based on personal associations. Also, at times the guided relaxation exercises will ask users to notice and be with their feelings, which can sometimes evoke distress in some users. Please consult with your physician or mental health clinician before using the software if you have pre-existing mental health diagnoses.

Warnings and General Limitations: 

  1. Warning and general limitations related to the safe use of the Virtual Reality Hardware console (recommended for use with VRReliever software series) are applicable when used with VRReliever MD-710 software.
  2. Prior the usage of the commercial “off-the-shelf” Virtual Reality Hardware, it is required from the user to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware.
  3. VRHealth LTD is not responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware.
  4. Each VR training session using VRReliever series software shall not last longer than the continuous duration recommended by the hardware manufacturer.
  5. If user is experiencing symptoms associated with: tiredness; being under the influence of alcohol or drugs; digestive problems; emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches the training session must be terminated immediately.

Re-act CT-610 & Memorize CT-620 – Intended Use, Precautions and Contraindications

Rx Only – Medical Software

Re-act CT-610 – Intended Use, Precautions and Contraindications

The “Re-act” CT-610 (“Re-Act”) and “Memorize” CT-620 are both prescription only medical device software applications that provide various VR environments to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable: 

  • Guiding patients in the performance of various cognitive exercises 
  • Track and analyze motion and movement kinematics 
  • Monitoring changes in patient’s measurements over time 

The VRCogni CT-610 can be used as an assessment aid to determine the level of cognitive function for which there exists other valid methods of cognitive assessment. 

VRCogni CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. Moreover, they do not identify the presence or absence of clinical diagnoses. 

N-140 software is intended to be used by the following populations:

Software operators 

Licensed Health Care Providers (i.e. Physicians, Psychologists, Neurologists, Caregivers, Geriatricians etc.) and/or patients, that utilize physical activity as part of conventional treatment. 

End users 

Individuals that will benefit from using CT-610 to support the performance of their prescribed physical and/or cognitive exercises as part of their conventional treatment. 

Intended use environment:  

CT-610 software is intended to be used only in the following environments or areas: 

  • Hospital units; 
  • Clinics; 
  • Any other facility that utilizes physical/cognitive activity treatment; 
  • Home environment; 

Contraindications:

Before using the CT-610 software, the Health Care Provider (and/or the end user) shall make sure that the patient does not suffer from one or more of the following conditions: 

  1. Tumors or other space occupying lesion (SOL) of the cervical region;  
  2. Undiagnosed neurological symptoms/signs;  
  3. Acute fracture of the cervical spine (especially fracture of odontoid process (Dens)); 
  4. Pathological fractures of the spine;  
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised; 
  6. Odontoid (Dens) fracture; 
  7. Any condition where it is otherwise contraindicated to move cervical region actively or passively; 
  8. Any condition where it is otherwise contraindicated to move shoulder and/or arm and/or wrist’s anatomical structures actively or passively; 
  9. Any recent unexplained loss of consciousness. 
  10. Seizures or taking antiepileptic medications. 
  11. Any severe mental health disorder not already under the care of a clinician, such as psychotic, affective mood, stress or anxiety disorders. 
  12. Any acute/chronic condition causing tiredness, dizziness, nausea or vertigo.  
  13. Being under the influence of alcohol or recreational drugs

Additional Precautions:

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute/chronic condition; Health Care Providers are advised to disable or limit movements that may be harmful to the patient. If the user feels any discomfort, he should terminate the session immediately. 
  2. Upper limb (shoulder, arm and wrist) movements may exacerbate any pre-existing pain or discomfort. If the user feels any excessive pain or discomfort, he should terminate the session immediately.  
  3. Malignant conditions – patients diagnosed with SOL or other malignant condition require extra attention to prevent any damage associated with affected anatomical structures. 
  4. Some users with existing vertigo or nausea may experience an exacerbation of these symptoms in VR environment; If the user feels any discomfort, they should terminate the session immediately. 
  5. Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately. Health Care Provider discretion is advised. 
  6. Weak neck muscles/Acute neck pain – patients with weak neck muscles or irritable suffering from acute neck pain may experience difficulties carrying the weight of the VR headset. Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware weight. 
  7. If the user has a defibrillator, pacemaker, hearing aid or any other implanted medical device, he should not use the VR hardware without first consulting his physician or the manufacturer of the medical device as the VR hardware may interfere with its proper function. 
  8. Balance disorders – as VR experience is immersive, Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware if the patient has any pre-existing disorder affecting balance (e.g. Parkinson’s disease, multiple sclerosis, dementia). Patients showing any balance associated symptoms should be supervised closely and to use the VRCogni software while sitting. For some balance disorders, the patient might require protective harness and/or belt for support. 
  9. Contagious conditions – in order to avoid transferring of contagious conditions (like pink eye), the VR headset should not be shared with users with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp. 
  10. Health Care Providers are advised to use their clinical judgement before exposing the patient to VR hardware if he is taking medications which may provoke seizures or impair his vision or balance

Warnings and General Limitations: 

  1. All warnings and general limitations related to the safe use of the VR hardware console (recommended for use with VRCogni software series) are applicable when used with VRCogni software. 
  2. Prior the usage of the commercial “off-the-shelf” VR hardware, it is required from the user and the health care provider to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. It is the Health Care Provider’s responsibility to confirm that it is safe and continues to be safe for a specific patient to use the Virtual Reality Hardware (VRH) before using the VRCogni series software. 
  3. VRHealth Ltd shall not be held responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware. 
  4. Each VR training session using VRCogni series software shall not last longer than the continuous duration as recommended by the hardware manufacturer.   
  5. If the user is experiencing symptoms associated with loss of consciousness, involuntary movements/seizures, visual abnormalities, tiredness, dizziness, vertigo, nausea, digestive problems, emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches or any physical or emotional pain or discomfort, the training session must be terminated immediately

Rotate N-140 Intended Use, Precautions and Contraindications

Rx Only – Medical Software

Rotate N-140 – Intended Use, Precautions and Contraindications

The VRPhysio Home N-140 (“Rotate”) is a physical medicine and rehabilitation software, as a medical device, intended for use in cervical region rehabilitation and active cervical spine ROM assessment. The software enables:

  • Tracking motion and movement kinematics.
  • Guiding patients in the performance of physical exercises according to the treating medical practitioner’s guidelines.

N-140 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device.

N-140 software is intended to be used by the following populations:

Software operators 

Licensed Health Care Providers (i.e. Physical therapists, Physicians, Chiropractors etc.) and/or patients, that utilize physical activity as part of conventional treatment.

End users 

Individuals that will benefit from using N-140 to support the performance of their prescribed physical exercises as part of their conventional rehabilitation.

Intended use environment:  

N-140 software is intended to be used only in the following environments or areas:

  • Physical medicine hospital units;
  • Physical therapy clinics;
  • Any other facility that utilizes physical activity treatment;
  • Home environment;

Contraindications:

Before using the N-140 software, the Health Care Provider (and/or the end user) shall make sure that the patient does not suffer from one or more of the following conditions:

  1. Tumors or other space occupying lesion (SOL) of the cervical region;
  2. Undiagnosed neurological symptoms/signs;
  3. Acute fracture of the cervical spine (especially fracture of odontoid process (Dens));
  4. Pathological fractures of the spine;
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised;
  6. Odontoid (Dens) fracture;
  7. Any condition where it is otherwise contraindicated to move cervical region actively or passively;
  8. Any condition where it is otherwise contraindicated to move shoulder and/or arm and/or wrist’s anatomical structures actively or passively;
  1. Any recent unexplained loss of consciousness.
  2. Seizures or taking antiepileptic medications.
  3. Any severe mental health disorder not already under the care of a clinician, such as psychotic, affective mood, stress or anxiety disorders.
  1. Any acute/chronic condition causing tiredness, dizziness, nausea or vertigo.
  2. Being under the influence of alcohol or recreational drugs;

Warnings and General Limitations on the use of VRPhysio Home:

  1. All warnings and general limitations related to the safe use of the VR hardware console (recommended for use with VRPhysio Home software series) are applicable when used with VRPhysio Home N-140 software.
  2. Prior the usage of the commercial “off-the-shelf” VR hardware, it is required from the user and the health care provider to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. It is the Health Care Provider’s responsibility to confirm that it is safe and continues to be safe for a specific patient to use the Virtual Reality Hardware (VRH) before using the N-140.
  3. VRHealth Ltd shall not be held responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware.
  4. Each VR training session using VRPhysio Home series software shall not last longer than the continuous duration as recommended by the hardware manufacturer.  
  5. If the user is experiencing symptoms associated with loss of consciousness, involuntary movements/seizures, visual abnormalities, tiredness, dizziness, vertigo, nausea, digestive problems, emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches or any physical or emotional pain or discomfort, the training session must be terminated immediately.

Additional Precautions: 

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute/chronic condition; Health Care Providers are advised to disable or limit movements that may be harmful to the patient. If the user feels any discomfort, he should terminate the session immediately.
  2. Malignant conditions – patients diagnosed with SOL or other malignant condition require extra attention to prevent any damage associated with affected anatomical structures.
  3. Some users with existing vertigo or nausea may experience an exacerbation of these symptoms in VR environment; If the user feels any discomfort, they should terminate the session immediately.
  4. Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately. Health Care Provider discretion is advised.
  5. Weak neck muscles/Acute neck pain – patients with weak neck muscles or irritable suffering from acute neck pain may experience difficulties carrying the weight of the VR headset. Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware weight.
  6. If the user has a defibrillator, pacemaker, hearing aid or any other implanted medical device, he should not use the VR hardware without first consulting his physician or the manufacturer of the medical device as the VR hardware may interfere with its proper function.
  7. Balance disorders – as VR experience is immersive, Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware if the patient has any pre-existing disorder affecting balance (e.g. Parkinson’s disease, multiple sclerosis, dementia). patients showing any balance associated symptoms should be supervised closely. For some balance disorders the patient might require protective harness and/or belt for support.
  8. Contagious conditions – in order to avoid transferring of contagious conditions (like pink eye), the VR headset should not be shared with users with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp.
  9. Health Care Providers are advised to use their clinical judgement before exposing the patient to VR hardware if he is taking medications which may provoke seizures or impair his vision or balance.

Balloon Blast MT-220 Intended Use, Precautions and Contraindications

Rx Only – Medical Software

Balloon Blast MT-220 – Intended Use, Precautions and Contraindications

The MT-220 (“Balloon Blast“) is a physical medicine and rehabilitation software, as a medical device, intended for use in upper extremity and full body conventional rehabilitation and active shoulder ROM assessment. The software enables: 

  • Tracking motion and movement kinematics. 
  • Guiding patients in the performance of physical exercises according to the treating medical practitioner’s guidelines. 

MT-220 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. 

MT-220 software is intended to be used by the following populations:  

Software operators 

Licensed Health Care Providers (i.e. Physical therapists, Physicians, Chiropractors etc.) and/or patients, that utilize physical activity as part of conventional treatment. 

End users 

Individuals that will benefit from using MT-220 to support the performance of their prescribed physical exercises as part of their conventional rehabilitation. 

Intended use environment:  

MT-220 software is intended to be used only in the following environments or areas: 

  • Physical medicine hospital units; 
  • Physical therapy clinics; 
  • Any other facility that utilizes physical activity treatment; 
  • Home environment; 

Contraindications:

Before using the MT-220 software, the Health Care Provider (and/or the end user) shall make sure that the patient does not suffer from one or more of the following conditions: 

  1. Tumors or other space occupying lesion (SOL) of the cervical region;  
  2. Undiagnosed neurological symptoms/signs;  
  3. Acute fracture of the cervical spine (especially fracture of odontoid process (Dens)); 
  4. Pathological fractures of the spine;  
  5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised; 
  6. Any condition where it is otherwise contraindicated to move cervical region actively or passively; 
  7. Any condition where it is otherwise contraindicated to move shoulder and/or arm and/or wrist’s anatomical structures actively or passively; 
  8. Any recent unexplained loss of consciousness. 
  9. Seizures or taking antiepileptic medications. 
  10. Any severe mental health disorder not already under the care of a clinician, such as psychotic, affective mood, stress or anxiety disorders. 
  11. Any acute/chronic condition causing tiredness, dizziness, nausea or vertigo.  
  12. Being under the influence of alcohol or recreational drugs; 

Warnings and General Limitations on the use of VRPhysio Home:

  1. All warnings and general limitations related to the safe use of the VR hardware console (recommended for use with VRPhysio Home software series) are applicable when used with VRPhysio Home MT-220 software. 
  2. Prior the usage of the commercial “off-the-shelf” VR hardware, it is required from the user and the health care provider to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware. It is the Health Care Provider’s responsibility to confirm that it is safe and continues to be safe for a specific patient to use the Virtual Reality Hardware (VRH) before using the MT-220. 
  3. VRHealth Ltd shall not be held responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware. 
  4. Each VR training session using VRPhysio Home series software shall not last longer than the continuous duration as recommended by the hardware manufacturer.   
  5. If the user is experiencing symptoms associated with loss of consciousness, involuntary movements/seizures, visual abnormalities, tiredness, dizziness, vertigo, nausea, digestive problems, emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches or any physical or emotional pain or discomfort, the training session must be terminated immediately.  

Additional Precautions: 

  1. Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute/chronic condition; Health Care Providers are advised to disable or limit movements that may be harmful to the patient. If the user feels any discomfort, he should terminate the session immediately. 
  2. Upper limb (shoulder, arm and wrist) movements may exacerbate any pre-existing pain or discomfort. If the user feels any excessive pain or discomfort, he should terminate the session immediately.  
  3. Some users with existing vertigo or nausea may experience an exacerbation of these symptoms in VR environment; If the user feels any discomfort, they should terminate the session immediately. 
  4. Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately. Health Care Provider discretion is advised. 
  5. Weak neck muscles/Acute neck pain – patients with weak neck muscles or irritable suffering from acute neck pain may experience difficulties carrying the weight of the VR headset. Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware weight. 
  6. Heart conditions – CHF (Congestive Heart Failure) or other conditions that limit aerobic capacity, requiring adapting the training to suitable pace to prevent an excessive aerobic requirement. This may require the Health Care Provider to use a third-party monitoring device (such as heart rate monitor) to ensure patient safety or instruct patient to limit game speed to a comfortable pace. 
  7. If the user has a defibrillator, pacemaker, hearing aid or any other implanted medical device, he should not use the VR hardware without first consulting his physician or the manufacturer of the medical device as the VR hardware may interfere with its proper function. 
  8. Balance disorders – as VR experience is immersive, Health Care Providers are advised to use their clinical judgement before exposing the patient to the VR hardware if the patient has any pre-existing disorder affecting balance (e.g. Parkinson’s disease, multiple sclerosis, dementia). patients showing any balance associated symptoms should be supervised closely. For some balance disorders the patient might require protective harness and/or belt for support. 
  9. Contagious conditions – in order to avoid transferring of contagious conditions (like pink eye), the VR headset should not be shared with users with contagious conditions, infections or diseases, particularly of the eyes, skin or scalp. 
  10. Health Care Providers are advised to use their clinical judgement before exposing the patient to VR hardware if he is taking medications which may provoke seizures or impair his vision or balance. 

Luna CB-510 Intended Use, Precautions and Contraindications

Luna CB-510 Intended Use, Precautions and Contraindications

Intended use

The CB-510 (“Luna”) is intended to assist in the mitigation of pain, hot flashes and physical discomfort through distraction and supporting exercises, performed in a virtual reality (VR) environment using commercially available VR headsets. The CB-510 is a nonprescription device that can be used in clinical setting or at home, with or without the assistance of clinician. The CB-510 provides VR exercises and takes measurements which enables the patient and/or clinician to monitor changes over time. CB-510 does not provide a report that analyzes the measurements, makes medical diagnoses, or recommends treatment.

Luna software is intended to be used by the following populations:

End users:

Individuals that will benefit from using VRReliever series as support for pain mitigation, hot flashes and physical discomfort.

Intended use environment:

Luna software is intended to be used only in the following environments or areas:

• Home environment;

• Healthcare facilities

Contraindications

Before using the Luna software, the user must be sure that they do not suffer from one or more of the following conditions:

1. Tumors or other Space Occupying Lesion of cervical region;

2. Undiagnosed neurological symptoms/signs;

3. Acute fracture of the cervical spine (especially fracture of Odontoid Process (Dens));

4. Pathological fractures of spine;

5. Post MVA (Motor Vehicle Accident) with no previous physician screening, where spinal structures may be compromised.

6. Contagious or infectious conditions (while multiple users use same headset);

7. Facial lesions or superficial lesions that may have contact with the VR headset;

8. Any condition where it is otherwise contraindicated to move cervical region actively or passively;

9. Epileptic seizures;

10. For paced breathing module only – do not use if you suffer from active Asthma, Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure;

Any sever mental health disorder not already under the care of a clinician, such as dissociation disorders, psychotic disorders, or severe depressive trauma or anxiety disorders

Warnings and General Limitations on the use of VRReliever

1.      Warning and general limitations related to the safe use of the Virtual Reality Hardware console (recommended for use with VRReliever software series) are applicable when used with VRReliever CB-510 software.

2.      Prior the usage of the commercial “off-the-shelf” Virtual Reality Hardware, it is required from the user to carefully read all instructions, limitations, and precautions in the Health, Safety, and Warranty Guide attached to the hardware.

3.      VRHealth LTD is not responsible for any malfunctions, defects, or user errors related to the purchase, installation, and use of the above-mentioned hardware.

4.      Each VR training session using VRRelieverTM series software shall not last longer than the continuous duration recommended by the hardware manufacturer.

5.      If user is experiencing symptoms associated with: tiredness; being under the influence of alcohol or drugs; digestive problems; emotional stress or anxiety, suffering from cold, flu or headaches, migraines or earaches the training session must be terminated immediately.

Additional Precautions

1.      Neck movement may adversely affect users with cervical spine abnormalities, pain or other acute condition; If user feels any discomfort, they should terminate session immediately.

2.      Some users with existing Vertigo or Nausea may experience exacerbation of the symptoms in VR environment; If user feels any discomfort, they should terminate session immediately.

3.      Vision disorders – users requiring glasses that does not fit under the VR headset or have other major vision problem that does not allow clear viewing of the VR environment may not be able to use the software appropriately.

4.      Acute neck pain – users suffering from acute neck pain may experience difficulties carrying the weight of the VR headset.

5.      Consult with your physician before using the software if you have pre-existing vision abnormalities, neck pain or spine abnormalities, psychiatric disorders, suffer from a heart condition or other serious medical condition.

6.      If you have a pacemaker or other implanted medical device, do not use the VR Hardware without first consulting your doctor or the manufacturer of your medical device.

7.      Although the VRReliever Software is based on techniques and imagery that most users find relaxing, there is a chance that some of the imagery users encounter may evoke unintended anxious feelings based on personal associations. Also, at times the guided relaxation exercises will ask users to notice and be with their feelings, which can sometimes evoke distress in some users. Please consult with your physician or mental health clinician before using the software if you have pre-existing mental health diagnoses.