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What is the OL1000™ bone growth stimulator and how will it help me?
The OL1000™ bone growth stimulator is a nonsurgical treatment which your physician has prescribed to aid the healing of your fracture. The stimulator uses a very low-strength Combined Magnetic Field to activate the body’s natural healing process.9 In some patients, this healing process is impaired or absent. The fracture may not mend properly, and a nonunion results. The bone growth stimulator provided by Enovis has proven to be successful in helping to treat nonunions.6,10
Are there known side effects of OL1000™?
There are no known side effects related to the use of the OL1000™. Thousands of patients have worn OL1000™ to help heal their nonunions. OL1000™ may be safely used with non-magnetic fixation devices, such as screws, plates, or pins. A full list of contraindications can be found in the manual.
How often will I need to change the battery?
The OL1000™ will be delivered with a battery installed. A low battery symbol will appear on the LCD screen on your remote indicating when the batteries should be changed. There are additional 9V batteries included that should last for up to 9 months.
Can I wear the OL1000™ if I am pregnant?
The safety of the OL1000 or OL1000 SC is not known if you are pregnant or nursing a baby. Therefore, if you are pregnant or nursing, you should consult your doctor before using the OL1000™.
Wear
Do I need to wear the OL1000™ at the same time each day?
The unit will allow one 30 minute treatment per day. It is recommended to be worn approximately the same time each day.
Can I travel with my OL000™?
Yes. Although commonly not required, in advance of your travel, you may request a letter from our Customer Service Support department that will explain what the device is and how it operates. You can also keep your user manual available to quickly and easily identify the device for any security personnel. We recommend administering your 30-minute treatment prior to going through security, this will ensure when moving through the x-ray and imaging devices, that the unit cannot be turned on for the magnetic fields to interfere.
How do I know what size is best for me?
TREATMENT
What will OL1000™ treatment feel like? How will it affect my daily activities?
You should not feel the therapy during the 30 minute treatment. The OL1000™ unit is designed to be lightweight and adjustable for a comfortable fit. It is powered with a battery, which allows the unit to be portable. You can perform activities of daily living as recommended by your physician.
How long will my treatment last with the the OL1000™?
You will use your OL1000™ device as long as your physician prescribes. Each device functions for a maximum of 270 days. Normally, the device is used until your fracture has healed. Your physician will closely monitor your progress.
What do I do with the device when I am done using it?
After your treatment is complete and your doctor says you no longer need to use your OL1000™, you may dispose of the device yourself according to your local governing ordinances and recycling plans. You may also contact our Customer Support department for help with device disposal. The OL1000™ is not reusable. Each device is for single patient use only and cannot be re-sold or used on multiple patients.
INSURANCE
Will my insurance pay for the device?
Insurance policies are different depending on the plan you have. The OL1000™ bone growth stimulator is covered by the majority of health plans and workers compensation plans, including Medicare; specific coverage criteria must be met.
Does Enovis preauthorize the device with my insurance company?
If pre-authorization is required, Enovis will verify your eligibility and benefit levels to obtain a pre-authorization from the payer of record.
What happens if my insurance company denies the claim?
In the event the insurance carrier denies coverage, the claim will be forwarded to our appeals processing department on your behalf. Depending upon the outcome, Enovis may contact you to arrange payment options.
USE
What is the Spinalogic® Bone Growth Stimulator and how will it help me?
The Spinalogic® bone growth stimulator is a nonsurgical treatment which your physician has prescribed to help the healing of your fusion. The stimulator uses a very low-strength Combined Magnetic Field to activate the body’s natural healing process. In some patients, this healing process is impaired or absent. The fusion may not mend properly. The bone growth stimulator provided by Enovis has proven be successful in helping to treat lumbar spinal fusions after surgery¹
Are there known side effects of Spinalogic®?
There are no known side effects related to the use of this device. Thousands of patients have been prescribed Spinalogic® to help heal their spine fusions after surgery. Spinalogic may be safely used with non-magnetic fixation devices, such as screws, plates, or metal pins.
How often will I need to change the battery?
The Spinalogic will be delivered with a battery installed. A low battery symbol will appear on the LCD screen on your remote indicating when the batteries should be changed. There are additional 9V batteries included that should last for up to 9 months. If more are needed, please contact customer service.
Can I wear the Spinalogic® if I am pregnant?
The safety of the Spinalogic is not known if you are pregnant or nursing. Therefore, if you are pregnant or nursing, you should consult your doctor before using the Spinalogic.
Wear
Do I need to wear the Spinalogic® at the same time each day?
The unit will allow one 30 minute treatment per day. You have the flexibility to receive your treatment at any time you choose. It is recommended to be worn approximately the same time each day.
Can I travel with my Spinalogic®?
Yes. Although not commonly required, in advance of your travel, you may request a letter from our Customer Service Support department that will explain what the device is and how it operates. You can also keep your user manual available to quickly and easily identify the device for any security personnel. We recommend administering your 30-minute treatment prior to going through security, this will ensure when moving through the x-ray and imaging devices, that the unit cannot be turned on for the magnetic fields to interfere.
Can I use the Spinalogic if I have a Pacemaker?
The operation of your pacemaker may be affected from exposure to the CMF OL1000 or CMF Spinalogic magnetic fields. Please consult your prescribing physician to see if your device will be placed in close proximity to your pacemaker. This would include fractures of the upper extremities (e.g. wrist, arm) and spinal fusion procedures. Further screening by your attending cardiologist is also recommended such as with an electrocardiogram.
TREATMENT
What is my daily treatment time with the Spinalogic®?
The Spinalogic® is a simple, 30 minute daily treatment time
What will Spinalogic® treatment feel like?
You should not feel the therapy during the 30 minute treatment. The Spinalogic® unit is lightweight and adjustable for a comfortable fit. It is powered with a battery, which allows the unit to be portable. You can perform activities of daily living as recommended by your physician.
How long should I use my Spinalogic® device?
You will use your Spinalogic device as long as your physician prescribes. Each device functions for a maximum of 270 days. Normally, the device is used until your fracture has healed. Your physician will closely monitor your progress.
What do I do with the device when I am done using it?
After your treatment is complete and your doctor says you no longer need to use your Spinalogic, you may dispose of the device yourself according to your local governing ordinances and recycling plans. You may also contact our Customer Support department for help with device disposal. The Spinalogic is not reusable. Each device is for single patient use only and cannot be re-sold or used on multiple patients.
INSURANCE
Will my insurance pay for the device?
Insurance policies are different depending on the plan you have.The Spinalogic® bone growth stimulator is covered by the majority of health plans and workers compensation plans, including Medicare; specific coverage criteria must be met.
Does Enovis preauthorize the device with my insurance company?
If pre-authorization is required, will verify your eligibility and benefit levels to obtain a pre-authorization from the payer of record.
What happens if my insurance company denies the claim?
In the event the insurance carrier denies coverage, the claim will be forwarded to our appeals processing department on your behalf. Depending upon the outcome, Enovis may contact you to arrange payment options.
How Does it work?
The Manafuse™ bone growth stimulator is a nonsurgical treatment prescribed by your physician to help heal your bone fracture. The stimulator emits a Low Intensity Pulsed Ultrasound Stimulation (LIPUS) that, when placed directly on the skin over your bone fracture, assists in activating the body’s natural healing process. As reported in published data, Manafuse LIPUS technology offers statistically significant improvement in fracture healing when used as indicated.
If your fracture has been immobilized with a cast, you may require a window in your cast to properly apply the Manafuse treatment. Your device includes a strap to assist in keeping the transducer head comfortably and appropriately placed on the skin directly over your fracture. The strap and lightweight nature of the design allow you to perform daily activities while undergoing treatment but always check with your physician before performing activity while treating. You should not feel Manafuse LIPUS therapy during your treatment.
It is very important that you use your Manafuse device daily as prescribed. The Manafuse device will allow you to treat your fracture for 20 minutes per day for up to 343 days. While you have the flexibility to treat at any time you choose, it is recommended that you perform treatment at approximately the same time each day. Your device will track your daily treatment and your doctor may ask you to bring the device to your follow-up visits to check your usage history.
Your doctor will closely monitor your progress and will let you know when you no longer need to use your Manafuse device. Typically, treatment is continued until your fracture has healed. Once you have completed your treatment, you may choose to keep the device or return it to Enovis for recycling or proper disposal. Manafuse is a single-patient use device and may not be passed to other patients.
Are there known side effects of Lipus?
There are no known side effects related to the use of this device. Thousands of patients have been prescribed Low Intensity Pulsed Ultrasound to help heal their fractures. Please refer to your package insert to review additional information about your prescribed device.
Can I wear the Manafuse if I am pregnant?
The safety of the Manafuse is not known if you are pregnant or nursing. Therefore, if you are pregnant or nursing, you should consult your doctor before using the Manafuse.
Can I use the Manafuse if I have a pacemaker?
The operation of active, implantable devices, such as cardiac pacemakers, may be adversely affected by close exposure to the Manafuse device. Your physician should advise you or anyone who would be near you during treatment to be evaluated by their attending cardiologist or implant physician before starting treatment with the Manafuse device.
How effective is the Manafuse lipus technology?
- In a prospective, randomized, double-blind, placebo-controlled study of 67 tibial fresh fractures, LIPUS treatment accelerated healing by 38% - a difference of more than 8 weeks.1
- In a prospective, randomized, double-blind, placebo- controlled study of 61 distal radius fractures, LIPUS treatment accelerated healing by 38%.2
- A study of Low-Intensity Pulsed Ultrasound for the treatment of nonunion fractures reported an 86% heal rate with an average healing time of 5 months. The average age of the fracture at the initiation of treatment was 14.3 months.3
Individual patient results may vary.
USE
Can I travel with my Manafuse?
Yes. Although not commonly required, before you travel you may request a letter from our Customer Service Support department or your Enovis™ Sales Representative that will explain what the device is and how it operates. You can also keep your user manual available to quickly and easily identify the device for any security personnel.
How often will I need to charge my Manafuse?
A fully charged battery should last for 10 hours. You should fully charge your Manafuse device prior to your initial use. A charging cable is provided with your device. The Micro- USB plug end of the charger cord plugs into the bottom of the device. The other end plugs into the adapter, which plugs into a wall outlet. The charger requires a standard US 120 VAC, 60Hz, household electrical outlet. A “low battery” symbol will appear on the LCD screen on your remote indicating that the battery needs to be charged.
What do I do with the device when I am finished using it?
After your treatment is complete and your doctor says you no longer need to use your Manafuse, you may dispose of the device yourself according to your local governing ordinances and recycling plans. You may also contact our Customer Support department (800.263.6004) for help with device disposal. The Manafuse is not reusable. Each device is for single-patient use only and cannot be re-sold or used on multiple patients.
INSURANCE
Will my insurance pay for the device?
Insurance policies are different depending on the plan you have. The Manafuse™ bone growth stimulator is covered by the majority of health plans including Medicare and workers compensation plans; specific coverage criteria must be met.
Does Enovis preauthorize the device with my insurance company?
If pre-authorization is required, Enovis™ will verify your eligibility and benefit levels to obtain a pre-authorization from the payer of record.
What happens if my insurance company denies the claim?
In the event the insurance carrier denies coverage, the claim will be forwarded to our appeals processing department on your behalf. Depending upon the outcome, Enovis™ may contact you to arrange payment options.