CMF OL1000 SC Size 1 Bone Growth Stimulator Instruction Manual

: June 26, 2024
: CMF

CMF OL1000 SC Size 1 Bone Growth Stimulator Instruction Manual

Do not use this product before you read this manual very carefully. If you have questions, please call your doctor or Customer Care. See User Guide for the Customer Care telephone number in your area. Physician Manuals for CMF products can be found at http://www.djoglobal.com/ol1000

Figure 1. OL1000 SC1 Bone Growth Stimulator

User Profile

Patients, a patient’s caretaker, or a family member providing assistance can use this device. The user should be able to:

Read and understand the directions, warnings and cautions.
Place the device on the patient.
Be able to see or hear device signals.
Understand the treatment schedule as prescribed.

Purpose of the Device

Your doctor has asked you to use the OL1000 SC1 device (Figure 1, above) for your broken bone that will not heal (called “non-healing” or “nonunion”). When used properly, the device will produce a magnetic field over your broken bone. This field is meant to help the bone heal. To treat yourself, you must wear the device on the outside of your body for 30 minutes per day.

Description of the Device

The OL1000 SC1 is very easy to use, comfortable to wear, and safe to use. It is designed to create a magnetic field that stimulates your broken bone to heal. You will not feel the magnetic field the device produces when using it. The device has a single “push button” to start your treatment and will automatically shut off after 30 minutes. Each day you will hear one beep when you start treatment and two beeps when your treatment is complete. If you hear beeps before your 30-minute treatment is finished, a picture will be shown on the display screen. Refer to the Troubleshooting Information section on page 10 for help. The device records the number of days that it has been used. This number will appear on the display screen. This feature allows you and your doctor to keep track of your care.

When the Device Should Not be Used

Do not use without the prescription of a doctor.
Do not use the OL1000 SC1 if you have a synovial pseudarthrosis (condition where scar tissue forms between the ends of broken bone and prevents healing).
Do not use the OL1000 SC1 if you have a heart pacemaker or defibrillator unless your heart doctor has approved it.
Do not use the OL1000 SC1 if you have an implant made from magnetic materials at the site of your non-healing broken bone. Almost all implants used today are non-magnetic.

Risks and Benefits

The safety of the OL1000 SC1 is not known if you are pregnant or nursing a baby.
The safety and benefits of the OL1000 SC1 are not known for people whose bones are still growing (generally 18 years old or less).
Do not put weight on your broken bone if the bone pieces are able to move.
If your non-healing broken bone is crooked, note that the OL1000 SC1 is not intended to help it become less crooked as it heals.
The safety and benefits of the OL1000 SC1 are not known for a non-healing broken bone that is caused by a disease rather than an injury.
Do not use the OL1000 SC1 if you are unwilling or unable to follow your doctor’s orders or the device instructions.
If you have bone loss or if your broken bone has been unhealed for a very long time, the OL1000 SC1 may not work as well.
The device may not work properly and your treatment may be longer unless you do the following:
– Always follow your doctor’s instructions
– Always follow your daily treatment schedule
– Always change the batteries when they need it
– Always take proper care of the device
The benefit of the OL1000 SC1 is that you have a greater chance of healing if you use the device than if you do not use it.

Warnings

Do not use the OL1000 SC1 near products that may have strong magnetic fields, such as audio speakers. The device may not work properly around these products.
WARNING! This device is intended only for single patient use. Secondary use can cause serious injury, including infection.
Care must be taken when operating this device adjacent to other equipment. Potential electromagnetic or other interference could occur with this or other equipment. Try to minimize this interference by increasing the separation between this device and nearby equipment, and by not using other equipment (i.e. cell phones, MRI, electro surgery, defibrillation, etc.) when you are using this device.
The equipment should not be used adjacent to or stacked with other equipment and, if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation in the configuration in which it will be used.
Do not use the OL1000 SC1 while smoking or near heat, fire or flammable gases because the device may be damaged.
Do not use the OL1000 SC1 if there are exposed wires or the device appears damaged.
Do not modify or repair this device because you may damage it.
Do not put the device or any of its parts in any liquid.
Do not drop the device or bend the coils because this may damage it.
Device is designed to comply with electromagnetic safety standards. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this equipment on and off. Try to correct the interference using one or more of the following:
– Reorient or relocate the receiving device.
– Increase the separation between the equipment.
– Contact DJO Customer Care.
Some people, with very sensitive skin, may experience redness. Generally, this redness is totally harmless and usually disappears after 10 to 20 minutes. However, never start another treatment on the same area if the redness is still visible.
If the performance of the device varies in any way from the described operation, call Customer Care.
The use of other cables and accessories may affect EMC performance.
This device and its accessories must be kept out of the reach of children, Pets, and Pests.
Do not use device in contact with open wounds.
Contamination by Patient could be sweat, expired gases, saliva, on the Spinal Logic. Clean the applied part of the coil once a week using antibacterial soap and a damp cloth.
Do not use device while in bath or shower.

Cautions

DO NOT operate this unit in an environment where other devices are being used that intentionally radiates electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.

Center the device’s coil around the broken bone. (See illustrations in appendices.)
Close the strap.
To start a treatment, press the “push button” next to the liquid crystal display (LCD) screen (see Figure 2), hold it down until it beeps, and then let go.
a. The treatment record will be displayed until it beeps.

b. The 30-minute treatment countdown will begin.

c. After 30 minutes, the “treatment complete” icon will appear on the LCD screen, the device will beep twice and it will automatically shut off.

Remove the device and store it until the next day. Please see the Device Care and Storage section on page 9 for instructions on the proper storage of the device.

Display Screen

When using the device, the LCD screen will show the time remaining for your daily treatment. The screen may look like this:

In this example, there are 29 minutes and 37 seconds remaining in the 30-minute treatment.

Checking the Treatment Record

You may check your treatment record at any time, except during your daily 30-minute treatment. To view the treatment record, press the “push button” and then let go before it beeps. The LCD screen will look like this:

The number in the left-hand corner of the OL1000 treatment record is the number of days you have successfully treated. The number in the right-hand corner is the number of days since you first used the device. If the daily treatment has already been completed for that day, and the “push button” is pressed, the treatment record will be shown followed by the “treatment complete” icon. This is a reminder that your daily treatment has already been completed for that day.

Safe Battery Care Information

Never heat or throw the batteries in a fire.
Never charge the batteries.
Never let the battery ends contact each other or other metal. Do not let a piece of metal touch both ends of a battery at the same time.
Never damage or use damaged batteries.
Never mix old and new batteries together or use batteries other than in their correct position.
Always keep batteries at room temperature, about 70°F (20°C) in less than 80% relative humidity and out of direct sunlight.
Only use the batteries supplied in the carrying case with the OL1000 SC1.
Remove primary batteries when equipment is not likely to be used for some time to avoid battery leakage.
The batteries may be replaced only after the display turns off.
Note: Be sure to remove plastic from batteries before replacing them.

Replacing the Batteries in the OL1000 SC1

WARNING : Battery operated device (9V alkaline battery), not to use lithium batteries.

The LCD screen will show the following picture when it is time for new batteries. This picture will be shown at the start of a treatment or during a treatment. The device will turn off after this picture is displayed.

Never change the batteries when the device is running. Wait until the device stops operating to change the batteries.

For the OL1000 SC1, the picture in Figure 3, below, shows the correct way to replace the battery. When replacing the battery, you will see the correct way to put them in on the inside of the battery compartment. Use ONLY the batteries supplied with the OL1000 SC1. They are located in the carrying case.

Note: Be sure to remove plastic from batteries before replacing them.

Figure 3. OL1000 SC1 – Battery Compartment

Additional Information

The device can be used ONLY 270 days in a row (about nine months). Use the device as long as your doctor tells you to.
Please take the device with you every time you go to your doctor.
In clinical studies, the earliest time to heal was three months. The average time to heal was six months. Some non-healing broken bones may take longer to heal.
There are alternatives to using the OL1000 SC1. These include having surgery or using other medical devices. Please ask your doctor if you have any questions about other choices for treating your non-healing broken bone.

Device Care and Storage

Clean the surface regularly with antibacterial soap and a damp cloth.
Always store the device in its carrying case in a cool, dry place. Never keep it where the temperature is less than 41°F (5°C) or greater than 104°F (40°C). Temperatures below or above could damage the device.
Never store the device or any of its parts in an automobile in cold or hot weather.
Always store the OL1000 SC1 in the carrying case provided with the device. The carrying case will protect the device when not in use. It also stores the extra batteries and this manual.
To avoid the risk of choking or strangulation, always store the OL1000 SC1 in its carrying case out of reach of small children.

Use While Traveling

You should try to use the OL1000 SC1 at the same time every day. The clock inside the device counts each day starting at midnight Pacific Standard Time (PST), 8:00 AM Greenwich Mean Time (GMT), or 7:00 AM (GMT) during daylight savings, and will only allow one treatment every 24 hours. If you travel outside of your normal time zone, you should try to treat at the same time you normally would at home. Do not take the OL1000 SC1 through airport x-ray machines because the x-rays may damage the device.

Troubleshooting Information

If you hear beeps before your 30-minute treatment is complete, there may be a problem with your device. Look at the LCD screen for a picture. Table 1 below shows pictures that may appear on the LCD screen and other common problems (left side of table). The action to take for each picture or problem is on the right side of the table.

TABLE 1: DISPLAY MESSAGES

A summary is shown below of other pictures that may appear on the LCD screen

User Assistance Information

For servicing of the OL1000 SC1 or for further information concerning the use of the device, please contact Customer Care. When your treatment is completed, you should take it to your local recycle center where the unit may be taken in as an electric recycle, like a television or computer. You may also contact Customer Care for assistance with device disposal. The OL1000 SC1 is not reusable. These devices are intended for single patient use only. It cannot be re-sold or used on multiple patients.

Customer Care Telephone Numbers

United States: 800.263.6004
Canada: 800.263.6004
Europe: T +44.1483.459.659
F +44.1483.459.470

Appendix A – Shoulder (Clavicle) Use

Remove liner pad. (Figure 2)
Remove Velcro tab “A” and loosen strap. (Figure 1)
Feed strap through slot until it is free, leaving the strap attached only on the side of the unit with the cord.
Attach long strap to the open slot.
Replace liner pad. (Figure 2)
Center treatment coil over fracture site as prescribed by your physician. (Figure 3)
Longer strap should fall down the back, and the shorter strap and cord should fall down the front. (Figure 4)
Bring the longer strap around the front of the torso, and attach to the short strap making sure the unit is secured over the fracture site. (Figure 4)

Appendix B – Hand/Wrist (Metacarpals and Phalanges) Use

Remove Velcro tab “A” and loosen strap. (Figure 1)
If unit is to be applied over a cast, remove liner pad. Otherwise, leave liner pad installed. (Figure 2)

Option 1

Place hand through strap opening. (Figure 3)
Center treatment coil directly over fracture site as prescribed by your physician and secure strap. (Figure 4)
Place hand/wrist on a stable surface with the palm facing down (Figure 3)
To tighten or loosen the strap, remove and reposition Velcro tab “A”. Adjust strap until it feels comfortable and secure. (Figure 1)

Option 2

Place the coil on a stable surface with the softgood facing up. (Figure 5)
Center the treatment site on top of the softgood pad and secure the strap. (Figure 4)
To tighten or loosen the strap, remove and reposition Velcro tab “A”. Adjust strap until it feels comfortable and secure. (Figure 1)

Appendix C – Foot/Ankle (Metatarsals and Phalanges) Use

Remove Velcro tab “A” and loosen strap. (Figure 1)
If unit is to be applied over a cast, remove liner pad. Otherwise, leave liner pad installed. (Figure 2)
Place foot through strap opening. (Figure 4)
Center treatment coil directly over fracture site as prescribed by your physician and secure strap. (Figure 3)
To shorten or lengthen the strap, move Velcro tab “B” along the strap. (Figure 1)
To tighten or loosen the strap, remove and reposition Velcro tab “A”. (Figure 1)

Symbols

The markings on the SpinaLogic Bone Growth Stimulator are your asurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility. One or more of the following markings may appear on the device and/or packaging:

Compliance Statements

Electromagnetic Compatibility (EMC)

The Bone Growth Stimulator has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices to IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.

Caution : Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions. It is possible that high levels of radiated or conducted radio- frequency electromagnetic interference (EMI) from portable and mobile RF communications equipment or other strong or nearby radio-frequency sources, could result in performance disruption of the system. Evidence of disruption may include image degradation or distortion, erratic readings, equipment ceasing to operate, or other incorrect functioning. If this occurs, survey the site of disruption, and take the following actions to eliminate the source(s).

Turn equipment in the vicinity off and on to isolate disruptive equipment.
Relocate or reorient interfering equipment.
Increase distance between interfering equipment and your system.
Manage use of frequencies close to the system frequencies.
Remove devices that are highly susceptible to EMI.
Lower power from internal sources within the facility control (such as paging systems).
Label devices susceptible to EMI.
Educate clinical staff to recognize potential EMI-related problems.
Eliminate or reduce EMI with technical solutions (such as shielding).
Restrict use of personal communicators (cell phones, computers) in areas with devices susceptible to EMI.
Share relevant EMI information with others, particularly when evaluating new equipment purchases which may generate EMI.
Purchase medical devices that comply with IEC 60601-1-2 EMC Standards (3V/meter EMI immunity, limit interference level to 0.0014 V/meter).

Declarations EMC Tables

ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES for RF Emissions Class B

Warranty

It is DJO, LLC policy that all complaints about our devices be communicated to Customer Care at 800-263-6004. The Customer Service Representative will provide technical assistance to determine the extent of the problem or educate the patient on the use of the device. If the device cannot be made to function properly, a replacement device is sent to the patient free of charge and the malfunctioning device is brought back for testing and evaluation. This procedure can be done at any time, and as many times as necessary, during the course of treatment. The course of treatment is defined as the nine (9) month period between the time the device is initiated and the Two Hundredth Seventieth (270th) treatment.