Bone Stimulator Q&A

Seventh Street Medical Supply, Inc.

Bone Stimulator Q&A

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Frequently Asked Questions

. What is the CMF OL1000 Bone Growth Stimulator and why did my doctor prescribe it for me?

The CMF OL1000 Bone Growth Stimulator is a lightweight, portable, and non-surgical treatment therapy. It uses advanced technology designed to promote the healing of your bone fracture that has failed to heal in a normal period of time.

Your physician is recommending the CMF OL1000 because it can aid in the healing of your nonunion fracture. It is a safe, cost-effective alternative to bone graft surgery that minimizes the risk and trauma to you as a patient.

2. Why did my fracture healing process stop and will I heal?

Bone is a living tissue that has the ability to heal itself when broken. Occasionally, bone fractures will fail to heal in a normal period of time. This condition is commonly referred to as a nonunion fracture.

In the case of your fracture, the cause of nonunion is not entirely understood and the diagnosis of your specific condition may indicate that this bone growth stimulator treatment is the best alternative for you. By using the CMF OL1000 under the close supervision of your doctor, there is a very strong chance of stimulating your fracture’s normal healing process.

3. Is the CMF OL1000 as effective as surgery?

The CMF OL1000’s success rate is comparable to surgical success rates without the risks or trauma associated with surgery.

4. What is CMF SpinaLogic^® and why did my doctor prescribe it for me?

CMF SpinaLogic is a lightweight, battery powered, non-surgical bone growth stimulator. It uses advanced technology designed to promote the healing of your spinal fusion site and is used adjunctively to surgery. Your doctor prescribed CMF SpinaLogic because using CMF SpinaLogic will help your spine to fuse.

5. How do the CMF OL1000 and CMF SpinaLogic work?

As early as the 1800’s, physicians were using electrical currents to successfully stimulate the healing of bone fractures. By the 1950’s, scientists discovered that bone generates its own electrical fields when it is bent or broken. It is this electrical field that helps stimulate the body’s normal healing process at the fracture or fusion site.

The CMF OL1000 and CMF SpinaLogic bone growth stimulators produce very low energy, Combined Magnetic Fields (CMFs). These very specific electromagnetic fields help stimulate the same normal healing process at your fracture or fusion site.

6. Are the CMF OL1000 and SpinaLogic® safe?

Yes, the CMF OL1000 and CMF SpinaLogic are completely safe for you to use. In fact, the CMF signal generated by these devices is less than the strength of the earth’s magnetic field. However, CMFs are very specific and potent in their ability to help stimulate your body’s normal healing process at your fracture or fusion site. Furthermore, there are no known significant side effects related to the use of these devices.

Thousands of patients have used the CMF OL1000 and CMF SpinaLogic to successfully heal their nonunion fractures and spinal fusion procedures. You may also use our bone growth stimulators in the presence of external or internal fixation such as rods, plates, screws or pins composed of nonmagnetic material. (Please see the CMF OL1000 or CMF SpinaLogic brief prescribing information for more information).

7. How long will it take to heal using the bone growth stimulator?

Your physician will closely monitor your progress to determine the length of your treatment period. Three to nine months of use with the device is recommended for adequate treatment. As the patient, you are an active participant during your treatment process, and it is important that you wear your device daily as prescribed by your physician.

8. How often will I need to use the CMF OL1000 or CMF SpinaLogic?

Pre-market clinical study results conducted with the CMF OL1000 show that you will require one treatment per day for only 30 minutes in order to achieve healing of your problem fracture.

The same holds true with the CMF SpinaLogic device. One 30-minute treatment per day is all that is required to use SpinaLogic.

9. If I wear it for longer than 30 minutes a day, will I heal faster? Is 30 minutes per day enough time?

The CMF OL1000 and CMF SpinaLogic bone growth stimulators are programmed to run only 30 minutes a day. Once you have treated, the device will not allow additional treatments until the following day. The device’s internal clock will automatically reset each night to allow for the next day’s 30-minute treatment.

Due to the advanced CMF technology, the short 30-minute daily treatment is all that is required to effectively promote bone healing. The treatment you receive stimulates your bone’s growth factors such that, for approximately 24 hours after treating, the healing process continues. (Ryaby, Fitzimmons, et al.) Prior to the discovery of CMFs, bone growth stimulators using older technologies required patients to treat for a minimum of 8 to 24 hours per day. Now you have the advantage of using an advanced technology with the convenience of choosing a treatment time that fits comfortably within your schedule.

10. What time of day should I do the 30-minute treatment?

You can do the treatment at any point during the day, but it is suggested that you treat at the same time every day.

11. What if I miss a day of treatment?

It is recommended that you use your bone growth stimulator every day, so you’ll have the greatest chance of healing. However, if you miss a day of treatment, simply continue the following day with your normal treatment, at your regular treatment time.

12. How do I know it’s working?

A 30-minute treatment will begin after you press the button on the control box, hold it down until it beeps, and then let it go. You can see the treatment countdown in minutes and seconds on the liquid crystal display (LCD) of the control box. The treatment is completed when the countdown reaches zero and the device beeps twice.

13. Will I still heal if I don’t use it?

You may heal. However, clinical study results show that using CMF SpinaLogic^® for 30 minutes a day can increase your chances of healing by up to 21 percentage points. Nearly 2400 patients were reviewed in the CMF OL1000 post-registry data and demonstrated a 75% chance of healing when using the OL1000.

14. Will I feel anything during the course of my treatment?

You will not feel any sensation during the treatment because the device produces a very low energy CMF. The CMF OL1000 and CMF SpinaLogic are specifically designed with your safety, convenience, and comfort in mind.

15. Can I use the CMF OL1000 or CMF SpinaLogic if I am pregnant?

Pregnancy-related studies were not conducted with the CMF OL1000 or CMF SpinaLogic. The safety of use of these devices during pregnancy or nursing in humans has not been established. Please consult with your prescribing physician if you are pregnant or if you become pregnant during your treatment.

16. Can I use the CMF OL1000 or CMF 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.

17. Can I use the CMF OL1000 or CMF SpinaLogic if I’m wearing a brace or a cast?

Yes. The CMF OL1000 and CMF SpinaLogic will easily fit over most braces or casts and can be used in conjunction with them.

18. Can I use CMF SpinaLogic if I have an implant in my back?

Yes. CMF SpinaLogic can be used with implants made from non-magnetic materials. Almost all implants used today are made from non-magnetic material, so these implants should not affect your treatment.

19. When will I receive my bone growth stimulator device and how will I know how to use it?

Here’s how the process will work:

Your doctor will write a prescription for the bone growth stimulator.
That prescription will be sent to the company so that we can process the order and contact your insurance company to confirm your coverage.
After your coverage has been confirmed, you will receive a call from the company to discuss your coverage.
You will also receive a call from a representative to schedule a convenient time to meet with you, deliver the device, and show you how to use it.

20. Can the CMF OL1000 or CMF SpinaLogic go through an x-ray machine at the airport?

We recommend that you avoid any situation that could disturb the calibration of your device, which is battery powered and produces a very low energy magnetic field. This magnetic field is very sensitive and the device’s calibration may be disturbed by larger magnetic fields, such as microwaves, stereo speakers or large electronic devices (such as x-ray scanners).

If you will be traveling with the device, you can request a letter from our Customer Support department that will explain what the device is and why it should not go through the x-ray machine. This letter can be presented to the appropriate airport personnel.

21. 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 CMF OL1000 or CMF 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 CMF OL1000 and CMF SpinaLogic are not reusable. Each device is for single patient use only and cannot be re-sold or used on multiple patients.

22. How can I get an CMF OL1000 or CMF SpinaLogic?

A prescription from your doctor is an FDA requirement to receive either device. If you feel that you may benefit from using the CMF OL1000 or CMF SpinaLogic, talk it over with your physician. We have Sales Representatives nationwide that your doctor can contact to place an order.

23. Will my health insurance cover the cost of this treatment?

Although policies may differ in their coverage, the CMF OL1000 and CMF SpinaLogic are widely accepted and approved for treatment by most health insurance companies, health plans, and workers’ compensation plans. More importantly, insurance companies and worker compensation plans recognize the convenience of our 30-minute per day treatment for you as a patient and its effectiveness in helping to heal your nonunion fracture or spinal fusion. In addition, Medicare and Medicaid may also provide coverage for treatment.

Furthermore, we will confirm your insurance coverage after your doctor has prescribed the bone growth stimulator for you. You should check directly with your insurance company for details on your individual coverage (specifically regarding “durable medical equipment”).

24. Will I have a co-pay for the CMF OL1000 or CMF SpinaLogic device?

Although most insurance companies do provide coverage for bone growth stimulators, several insurance plans also require you, the patient, to pay a co-pay for the device. Co-pays vary with different insurance companies and with different insurance plans. You should contact your insurance company to discuss whether you will have a co-pay and how much that co-pay might be.

25. What happens if my insurance will not pay for the device?

If your insurance company will not pay for the device, you should contact our Reimbursement department at 1.888.624.5450 to discuss payment options.

26. Who should I call if I have questions?

If you have any questions related to your surgery or any treatments your doctor has prescribed for you, you should contact your physician directly. If you have any additional questions about the CMF OL1000 or CMF SpinaLogic device, you can refer to the CMF OL1000 or CMF SpinaLogic patient manual that is included with the device.

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307 East Pennsylvania Boulevard Feasterville, PA 19053
Phone: 215-396-2450 · 800-723-8110
Fax: 215-396-2454
info@seventhstreetmedicalsupply.com
Office Hours: 9:00am -5:00pm Monday thru Friday