Important Safety Information

Indications for Use

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Contraindications

Patients contraindicated for the Revi therapy are those who:

• Are unable, or do not have the necessary assistance, to operate the Revi System.
• Are men who have Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
• Are implanted with any metallic implant in the immediate area (8 in/20cm distance) intended for implantation.
• Have nerve damage that could impact treatment.
• Are at high surgical risk or patients with multiple illnesses or active general infections that expose them to excessive bleeding or delayed or non-healing wounds.
• Have known allergies to one of the implant materials.
• Are pregnant.
• Have open wounds or sores on the lower leg or foot.
• Had prior surgery in the implant area.
• Had previous, unhealed trauma in the implant area.
• Have pitting edema (≥2+) in the lower leg.
• Have Venous disease/insufficiency in the lower leg.
• Have Arterial disease/insufficiency in the lower leg.
• Have Vasculitis or dermatologic conditions in the lower leg.
• Have infections near the implantation site in the lower leg.

Use in specific populations

The safety and effectiveness of this therapy has not been established for:

• Patients under the age of 18
• Patients with progressive, systemic neurological diseases (e.g., Parkinson’s disease, multiple sclerosis (MS), etc.).

Warnings

⚠Warnings for use of the Revi System are outlined below, together with recommendations of the manufacturer.

Clinician Training

Before surgical implantation of the Revi Implant, treating clinicians/surgeons should be trained on the implantation procedure and use of the Revi System.

Driving/Operating Machinery – Limitations During Treatment

Patients whose normal daily activities include driving or operating machinery should be aware of the fact that it is not recommended to do so at any time during a Revi Treatment Session.

Flammable Fuel, Chemicals, or Environmental Hazards

The Revi Wearable Device and Clinician Programmer are not suitable for use in the presence of flammable fuel, fumes or chemicals, including flammable anesthetic mixtures with air or with oxygen or nitrous oxide.

When the system is turned on, or in use, it could potentially ignite the chemicals or fumes, causing severe burns, injury or death to patient and staff.

Medical Therapies/Procedures

The following therapies and procedures may cause injury to the patient, and/or permanent damage to the Implant, particularly if used in close proximity to the device:

• Diathermic therapy
• Electrosurgery
• Electrocautery
• Radiation therapy
• High-output ultrasound/High-intensity focused ultrasound/Lithotripsy
• Transcutaneous Electrical Nerve Stimulation (TENS)
• Bone growth stimulation
• RF (Radio Frequency) ablation
• Laser procedures
• Therapeutic magnets
• Hyperbaric chamber

Note: The compatibility of the wearable device has not been verified with any other medical therapy / procedure and thus should be removed prior to any medical therapy / procedure

Diathermy

Patients implanted with the Revi Implant should not be exposed to shortwave, microwave or ultrasound diathermy, at any location on the body or in their vicinity. Energy from these devices can be transferred through the Implant, causing severe injury or damage to the Implant.

Electromagnetic Interference

Although the Revi System is suitable for use in all establishments, including clinics, hospitals and domestic environments, the following warnings apply: 

• Do not use the Wearable Unit within 12 inches (30 cm) of:
  • Consumer electronic devices, such as TV sets, laptops, tablets and smartphones.
  • Metallic objects and strong magnets.

• The Revi Wearable Device must emit electro-magnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

For guidance regarding the Clinician Programmer’s hardware electromagnetic compatibility refer to the iPad User Guide at www.apple.com.

Magnetic Resonance Imaging (MRI)

For use of MRI when the Revi is implanted refer to “MRI Conditional Labeling” below.

• Do not conduct an MRI examination on a patient implanted with the Revi until you read and fully understand all the information in this manual. Failure to follow all warnings and guidelines related to MRI can potentially result in heating of the Implant, resulting in damage to surrounding tissue, damage to the Implant and unexpected changes in stimulation.
• A responsible individual with expert knowledge about MRI, such as an MR trained radiologist or MRI physicist, must assure all procedures in this guideline are followed and that the MRI scan parameters comply with the recommended settings during the MRI examination. The responsible individual must verify that parameters entered into the MRI system meet the guidelines in this section.
• Discontinue the MRI immediately if the patient becomes unresponsive to questions or experiences any heating, pain, shocking sensations/uncomfortable stimulation, or unusual sensations.
• The Revi System should not be activated during the MRI procedure.
• All external components and accessories of the Revi System are MR Unsafe and are contraindicated for the MRI environment and not allowed into the MRI suite. Therefore, the External Control Unit and Clinician Programmer must be removed before the patient is allowed into the MRI environment.
• The Revi Implant has not been tested in simultaneous combination with other devices in the MRI environment.

MRI Conditional Labeling

The Revi Implant is MR conditional as defined in ASTM F2503-13.

A patient implanted with the Revi Implant may be safely scanned anywhere in the body, under the following conditions:

1. MR system with static field of 1.5 T or 3.0 T. MRI may also be performed at field strengths less than 1.5 T.  
2. Maximum spatial gradient in the static field of 30 T/m.
3. Maximum scanner gradient slew rate of 200 T/m/s.
4. For 1.5 T MR scanners:
   • Landmark above the waist. Normal or first level controlled operating mode with maximum whole-body SAR of 4 W/kg. No restrictions on scan time due to implanted device. Actual scan time according to MRI scanner guidelines.
   • Landmark below the waist. Normal operating mode with maximum whole-body SAR of 2 W/kg. Allowed scan duration of 60 minutes of continuous RF (a sequence or back-to-back series/scan without breaks). Actual scan time according to MRI scanner guidelines.
5. For 3T MR scanners:
   • Landmark above the waist. Normal or first level controlled operating mode with maximum whole-body SAR of 4 W/kg. No restrictions on scan time due to implanted device. Actual scan time according to MRI scanner guidelines.
   • Landmark between the waist and the knee (not including the knee). Normal operating mode with maximum whole-body SAR of 2 W/kg. Allowed scan duration of 60 minutes of continuous RF (a sequence or back-to-back series/scan without breaks). Actual scan time according to MRI scanner guidelines.
   • Landmark at the knee and below. Normal operating mode with maximum whole-body SAR of 2 W/kg. Allowed scan duration of 30 minutes of continuous RF (a sequence or back-to-back series/scan without breaks). Wait 30 minutes before the next imaging session. Actual scan time according to MRI scanner guidelines.

The health state of the patient or the presence of other implants may require reduction of the MRI limits.

Information from non-clinical tests of MRI interactions on Revi Implant

RF heating was measured at 1.5 T and 3 T in phantom tests performed according to ASTM F 2182-11a. Under the conditions of the IFU, the maximum temperature rise during MRI of tissues near the Revi Implant is acceptable and is not expected to cause thermal damage to the surrounding tissue.

Magnetic force was measured according to ASTM F2052-15. Fixation of the device to the tissue will prevent device movement in the MRI static field.

Image artifact was measured according to ASTM 2119-13 in a 3T clinical MR system. Maximum artifact beyond the implant was 1.2 in (3 cm) for the spin echo sequence and 1.6 in (4 cm) for the gradient echo sequence. It may be possible to reduce artifact by use of suitable scan sequences.

Following ISO/IEC 10974 (2018) multiple exposures of Revi Implant to MRI electromagnetic fields were made at 1.5 T and 3 T. These exposures did not damage the device. RF and gradient fields during MRI are not expected to elicit unintended stimulation.

Implantable Devices

The effect of the Revi System on the operation of other implanted devices, such as, other neurostimulators, and implantable drug pumps, is not known. In particular, if the Revi System is implanted close to one of these devices, they may have sensing problems and/or may not function correctly. Potential interference issues should be investigated before surgery by clinicians involved with both devices. The programming of the devices may need to be optimized to provide maximum benefit from both devices.

Neurostimulator Interaction with Implanted Cardiac Devices

If a patient is in need of defibrillation or cardioversion, the first consideration is their survival.

External defibrillation or cardioversion can damage the Implant. After external defibrillation, confirm that the Revi System is working as intended. The stimulation pulses produced by the Revi System may interact with cardiac devices that sense cardiac activity, leading to inappropriate behavior of the cardiac device and the Revi Implant.

Precautions

⚠  Treating Clinicians/Surgeons should follow current clinical guidelines as applicable and should use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System.

⚠  Precautions for use of the Revi System are outlined below, together with recommendations of the manufacturer.

Metal Objects and Implants

External and implantable metal objects can impact the communication between the Revi Wearable Device and Implant when placed in proximity to the system. This may prevent or reduce the system’s abilities for stimulation.

Metal items should be kept at a distance of at least 8 in (20 cm) away from the Revi Wearable Device while delivering stimulation.

Strenuous Activities and Excessive Force

Patients should avoid strenuous activities (and excessive force) that put the Revi Implant under extreme stress. If the Implant casing is ruptured or pierced due to outside forces, the Implant will no longer be functional, and injury may result.

The following examples of strenuous activities can damage the Revi Implant resulting in loss of symptom relief and possible additional surgery: Gymnastics, Mountain biking, Skiing, Sky diving.

Less extreme activities should not impact the Revi Implant: Running, Jogging, Road biking, Swimming.

SCUBA Diving or Hyperbaric Chamber

SCUBA diving or going inside a hyperbaric change may damage the implant.

Electromagnetic interference

Electromagnetic interference from some electronic equipment or mobile devices may disrupt the communication between the Revi Wearable Unit and Clinician Programmer or between the Revi Wearable Unit and the Implant in certain situations, causing the stimulation to either stop or be uncomfortable.

As a precaution, follow these guidelines:

• If you suspect that an EMI equipment or environment is affecting the function of your Revi System, avoid performing the therapy session around that item by doing the following:
  • Move away from the electrical item
  • Turn off the electrical item (if possible)
• If you are unable to eliminate the interference or believe the interference has altered the effectiveness of your therapy, you should contact your clinician.

Sources of strong EMI can result in the following:

• Patient injury, resulting from heating of the Revi System that causes damage to surrounding tissue.
• System damage, which may require surgical replacement due to change in symptom control.
• Operational changes to the Revi Wearable Unit, causing it to turn on or off or to reset the settings, resulting in loss of stimulation or return of symptoms, causing a need for reprogramming.
• Unexpected changes in stimulation, leading to a sudden increase or change in stimulation, which may be experienced as a jolting or shocking sensation. While the sensation may be uncomfortable, the device would not be damaged, nor would it cause direct injury. In rare cases, the change in stimulation may cause you to fall and be injured.

Strong Electromagnetic Fields

Strong electromagnetic fields can impact the communication between the Revi Wearable Unit and the Implant in certain situations, causing the Stimulation to either stop or be uncomfortable.

As a precaution, avoid performing Therapy Sessions around:

• Power lines or power generators.
• Electric steel furnaces.
• Large stereo speakers.
• Short-wave or microwave therapy equipment.

Theft Detectors and Security Screeners

Everyday electrical devices are not likely to affect Revi. There are strong sources of EMI that have a higher risk. These include theft detectors or security screeners such as those used at department stores, and/or airports.

It is possible that such devices may affect the communication between the Revi Wearable Unit and the Implant, causing the stimulation to either stop or be uncomfortable. Security screeners may also detect the metal in the Implant. Airport authorities advise patients to carry their Patient Identification Card with them when traveling.

As a precaution, if patients encounter security or theft detectors, they should walk far away from the sides of them when passing through and avoid performing their Revi therapy sessions around them. Patients should make sure security staff are informed that they have an implanted stimulator and carry their patient identification card with them for verification.

Revi Wearable Unit Placement Site

The Revi Wearable Unit is Non-Sterile and not to be sterilized and should not be applied to an open wound. Contact with an open wound could cause an infection.

The Revi Wearable Unit should not be used if the skin in the area surrounding the implant site is inflamed, infected, or otherwise compromised.

Swelling along with pain, warmth and excessive redness in the implantation site could be a sign of infection, Implant rejection or an allergic reaction to the Leg Band material.

If patients experience these symptoms near the Wearable Unit’s placement site, they should contact their clinician before using the device.

Travel and International Use

⚠ Important: When traveling, it is important the patient continues adhering to their Revi Treatment regimen.

⚠ Caution: It is possible that airport security devices may affect communication between the patient’s Revi Wearable Unit and the Revi Implant.

⚠ Caution: In addition, communication between the Revi Wearable Unit and the Revi Implant may cause interference with the navigation or communication system of the aircraft.

As a precaution, performing a Treatment Session during a flight should be avoided.

Note: Use of a power adapter may be necessary when using the battery charger in different countries.

Sterilization, Handling and Storage

• Labels on system components
  • Safety labels are applied to: Revi Clinician Programmer, Revi Wearable, Revi Implant
  • Do not use the product if the labeled “Use by” date has passed.
  • Do not use if labeling is incomplete or illegible.
• Handle the Revi System components with care. Dropping system components on hard surfaces, or other rough handling, can damage it.
• Do not use system components if package has been dropped on a hard surface from a height of more than 24 in (60 cm).
• Avoid exposing the Revi System components to extreme temperatures, moisture or pressure.
• Do not use any component that shows sign of damage.
• Use only Revi System components with the device. No modification of this equipment is allowed. Use of components from other systems or modified components may damage the system or cause injury.
• Only BlueWind Medical’s trained and authorized service engineers shall be permitted to service the system.
• The Revi Implant:
  • The Revi Implant is sterilized by ethylene oxide. Inspect the condition of the sterile package before opening the package and using the contents. Do not use the contents if the package is broken or torn, or if contamination is suspected due to a defective sterile package seal.
  • The Implant is for single use only. Do not reuse. Reprocessing of single use devices may create a risk of contamination and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
  • Do not re-sterilize the package or its contents. Re-sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness, or death. 
• The Revi Wearable Device:
  • The Revi Wearable Device is not sterile and should not be sterilized by any means. For delivering stimulation during the surgical procedure the Wearable Unit should be placed inside a sterile sleeve or drape.
  • The Revi Wearable Device is water resistant, but not waterproof. Do not use the device in or around water.
• The Revi Clinician Programmer:
  • The Revi Clinician Programmer is not sterile and should not be sterilized by any means.
  • The Clinician Programmer is intended for use as a monitor during the procedure, outside of the sterile field.

Water Resistance

The Revi Wearable Unit is water resistant, but not waterproof (i.e., water can be repelled to some degree but not completely). The device should not be used in or around water.

Using the wearable device while / after it has been immersed in water could lead to electrocution or damage to the device.

If the device has been damaged, contact your BlueWind Medical for replacement.

Device Components

Please do not tamper or modify the Revi Wearable Unit. No modification of this equipment is allowed.

Use of components from other systems or modified components may damage the system or cause injury.

Service Life

The Revi Wearable Device service life is 1 year.

The Revi Implant lifetime is 10 years from implantation.

The Revi Clinician Programmer lifetime is limited only by the hardware (for details see iPad User Guide at www.apple.com).

The system can fail due to random component failure, or loss of battery functionality.

In the case where one of the system components is damaged or stops working, the component should not be used and returned to BlueWind Medical. There are no user serviceable system components.

If the Revi Implant reaches its end of life, contact BlueWind Medical to arrange a removal or replacement for continued therapy as needed.

Component Disposal

Revi System components should not be disposed as unsorted municipal waste.

Contact BlueWind Medical Ltd. for instructions on returning the system component to the manufacturer.

Disposal of the battery chargers should be in accordance with local municipal guidelines.

Possible Adverse Events

Potential risks are associated with any implantation surgery, or use of a neurostimulation system.

Anticipated adverse events involved with the surgery include, but are not limited to: bleeding, pain at implantation site, ankle discomfort, implant site infection, skin irritation, nerve injury, skin erosion, seroma, formation of thrombosis and pulmonary embolism, potential temporary or permanent mobility impairment and nerve injury.

Anticipated adverse events involved with the stimulation include, but are not limited to: undesirable changes in stimulation such as sensation of transient electric “shock”/sudden radiating sensation/sporadic sensory response, uncomfortable heating effect, discomfort, or transient muscular spasm induced by stimulation.

Anticipated adverse events involved with the treatment include, but are not limited to: adverse changes in voiding/bowel function, or transient nausea.

Anticipated adverse events involved with the device include, but are not limited to: spontaneous sensory response (not in association with simulation), implant migration or displacement, allergic reaction and technical device problems.

Adverse events that were reported in a previous study included 4% device related Adverse Events, all of which were reported as pain associated with the device (i.e., treatment/stimulation), and 10.6% procedure related AEs, of which 6.6% were related to the surgical wound.¹

Most adverse events resolve within a few days to a few weeks on their own or with medication.