CMF OL1000 Bone Growth Stimulator Instruction Manual

CMF OL1000 Bone Growth Stimulator

Product Information

Specifications

• Product Name: OL1000 & OL1000 SC Bone Growth Stimulator
• Model Numbers: REF 01-203-0001, REF 01-211-0002, REF 01-211-0003, REF 01-211-0004
• Usage: To aid in bone healing for nonhealing or nonunion fractures
• Treatment Time: 30 minutes per day
• Battery: 9V alkaline battery (not compatible with lithium batteries)

Product Usage Instructions

User Profile
Your doctor has recommended the use of OL1000 or OL1000 SC for nonhealing fractures. The device generates a magnetic field to assist in bone healing. It should be worn externally for 30 minutes daily.

Description of the Device
The device produces a magnetic field over the broken bone to aid in healing.

When the Device Should Not be Used
Consult your doctor if you have any doubts about using the device.

Directions for Use

Putting on the OL1000:

1. Center the device around the broken bone area on your body.
2. If needed, remove foam pads for a better fit.
3. Close the strap if provided.

Putting on the OL1000 SC:

1. Place the device’s coil around the broken bone.
2. Close the strap if applicable.
3. To start treatment, press the push button next to the LCD screen, hold until it beeps, and release.
4. The treatment record will be displayed, followed by a 30-minute countdown.
5. After treatment, the device will automatically shut off.
6. Store the device properly until the next use.

Display Screen
The LCD screen shows the remaining time for your daily treatment. The screen also displays treatment records.
Safe Battery Care Information
Only use a 9V alkaline battery and avoid lithium batteries for replacement.

Replacing the Batteries
WARNING: Do not use lithium batteries; only use 9V alkaline batteries.

FAQ

• Q: How long should I use the device daily?
  A: Use the device for 30 minutes per day as recommended by your doctor.

• Q: Can I check my treatment record during the daily treatment?
  A: You can check your treatment record at any time except during the 30-minute daily treatment.

• Q: How should I store the device when not in use?
  A: Please refer to the Device Care and Storage section on page 12 of the manual for proper storage instructions.

• Q: What type of battery should I use for replacement?
  A: Only use a 9V alkaline battery for replacement. Do not use lithium batteries.

OL1000 & OL1000 SC
Bone Growth Stimulator

•  Please read before using device
  Caution: Federal law (U.S.A. and Canada) restricts this device to sale, distribution or use by or on the order of a physician.

• www.djoglobal.com/CMF

• Do not use this product before you read this manual very carefully. If you have questions, please call your doctor or Customer Care. See page 15 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 & OL1000 SC Bone Growth Stimulators

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 or OL1000 SC 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 or OL1000 SC is very easy to use, comfortable to wear, and safe to use. It is designed to create a magnetic field that stimu-lates 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 treat-ment 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
• Informa-tion section on page 13 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 or OL1000 SC 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 or OL1000 SC if you have a heart pace-maker or defibrillator unless your heart doctor has approved it.
• Do not use the OL1000 or OL1000 SC 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 or OL1000 SC is not known if you are pregnant or nursing a baby.
• The safety and benefit of the OL1000 or OL1000 SC 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 or OL1000 SC is not intended to help it become less crooked as it heals.
• The safety and benefit of the OL1000 or OL1000 SC are not known for a non-healing broken bone that is caused by a disease rather than an injury.
• Do not use the OL1000 or OL1000 SC if you are unwilling or 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 or OL1000 SC 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 or OL1000 SC 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 or OL1000 SC 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 or OL1000 SC while smoking or near heat, fire or flammable gases because the device may be damaged.
• Do not use the OL1000 or OL1000 SC 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.

Directions for Use

• CAUTION: Never use the device if the temperature around you is less than 41°F or over 104°F (5°C to 40°C) or the device may not work properly. The device should be in this temperature range for one hour before treating.

Putting on the Device
Your doctor or service representative will:

• Show you how to place the device correctly over the spot of your non-healing broken bone;
• Show you how to use the latch or straps to hold the device in place, if needed; and
• Show you how to use the device.

Starting Each Day’s Treatment

• Put the device on as you were shown.
• Use the device as you were shown.

Putting on the OL1000

1. Place device (Figure 2, above) centered around where your broken bone is located on your body. If you have a cast, brace or external fixator, you may remove the foam pads from the OL1000 for a better fit.
2. Close the strap, if you use one.

Putting on the OL1000 SC
For examples of how to place the OL1000 SC on various areas of the body, please see the Appendices.

1. Center the device’s coil around the broken bone. (See illustrations in Appendices.)
2. Close the strap, if you use one.
3. To start a treatment, press the “push button” next to the liquid crystal display (LCD) screen (see Figure 3), hold it down until it beeps, and then let go.
   • The treatment record will be displayed until it beeps.
   • The 30-minute treatment countdown will begin.
   • After 30 minutes, the “treatment complete” icon will appear on the LCD screen, the device will beep twice and it will automatically shut off.
4. Remove the device and store it until the next day. Please see the Device Care and Storage section on page 12 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 treatment record is the number of days you have successfully treated. The number in the upper right-hand corner is the number of days since you first used the device. In this example, it has been 204 days since the device was first used, and 124 treatments have been successfully completed.
If the daily treatment has already been completed for that day, and the “push button” is pressed, the treatment record will be shown fol-lowed 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 or OL1000 SC.
• 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

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

• Replacing Batteries in the OL1000 & OL1000 SC
  The picture in Figure 5, 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 device. They are located in the carrying case.

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 or OL1000 SC. 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 only.
• 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 or OL1000 SC 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 or OL1000 SC in its carrying case out of reach of small children.

Use While Traveling
You should try to use the OL1000 or OL1000 SC 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 nor-mally would at home. Do not take the OL1000 or OL1000 SC 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

1. If the device looks damaged, call Customer Care.
2. If not, try moving to another location in your house. Make sure you are not near metal objects.
3. If the picture is still displayed, re- place the batteries with new ones.
4. If the device still shows the picture, call Customer Care.

| Replace Battery – announced by three beeps. Replace the batteries with new ones.
| Phone For Help – announced by three beeps. Call Customer Care.
PROBLEM| ACTION TO BE TAKEN
---|---
The device will not turn on, but there is no error message. You may still hear a beep.|

1. Try replacing the batteries with new ones.
2. Wait until tomorrow and try treating again.
3. If the device still will not turn on, call Customer Care.

There are lines or bars on the display or the display is too dark to read.| Call Customer Care.
You do not hear any beeps.|

1. The beeper may not work if you live where it is very humid. The device will still work.
2. If you do not live where it is humid, listen again tomorrow for beeps. Have somebody else listen too.
3. If the device still does not beep, call Customer Care.

The device appears damaged.| Call Customer Care.
Your broken bone hurts more than it used to.| ****

1. Make sure that you are treating in a comfortable, relaxed position.
2. If you still have more pain than you used to, call your doctor.

You run out of batteries.| **** Call Customer Care.

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

User Assistance Information
For servicing of the OL1000 or OL1000 SC 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 and OL1000 SC are not reusable. These devices are intended for single patient use only. They cannot be re-sold or used on multiple patients.
Customer Care Telephone Numbers

• United States 800.263.6004
• Canada 800.263.6004
• Europe +44.1483.459.659

Appendix A – Shoulder (Clavicle) Use

OL1000 SC Application Instructions. Use for Size 2 & 3

1. Attach the short and long straps to the corners of the device by wrapping the tab end of the strap over the coil, inserting the tab through the open slot, and pulling the tab until tight.
2. With the long strap wrapping around the torso, position the coil over the long strap to the short strap.
3.  You may trim the excess strap and re-install the Velcro® hook closer.

Strap Washing Instructions
Hand wash with light detergent. Hang to dry; do not place in dryer

Appendix B – Upper Leg (Femur) Use
OL1000 SC Application Instructions. Use for Size 2, 3 & 4

•  With the strap on the inside of the leg, position the center of the coil over the treatment area and secure the long strap to the short strap.
• Strap Washing Instructions
  • Hand wash with light detergent. Hang to dry; do not place in dryer

Appendix C – Upper Arm (Humerus) Use
OL1000 SC Application Instructions. Use for Size 2 & 3

1. Attach the short and long straps to the corners of the device by wrapping the tab end of the strap over the coil, inserting the tab through the open slot, and pulling the tab until tight.
2. Attach the shoulder strap to the short and long straps. Adjust the length of the shoulder strap to raise or lower the position of the coil on the arm. Long strap attaches to the back side. Short strap  attaches to the front side.
3. Position the center of the coil over the treatment site
4. Secure the coil in place by wrapping the long strap around the torso and attaching to the shoulder strap.
5. You may trim the excess strap and re-install the Velcro® hook closer.
   • Strap Washing Instructions Hand wash with light detergent. Hang to dry; do not place in dryer

Symbols

The markings on the SpinaLogic Bone Growth Stimulator are your asurance of its conformity to the highest applicable standards of medi-cal 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 rea-sonable 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

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The Bone Growth Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Bone Growth Stimulator should assure that it is used in such an environment.
Emissions Tests| Compliance| Electromagnetic Environment Guidance
RF Emissions CISPR 11| Group 1| ****

The Bone Growth Stimulator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF Emissions CISPR 11| Class B| The Bone Growth Stimulator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions

IEC 61000-3-2

| N/A| N/A
Voltage Fluctuations IEC 61000-3-3| N/A| N/A
N/A| N/A| The Bone Growth Stimulator emits a sinusoidal magnetic field with a peak to peak -[amplitude of 400mG and a 200mG D.C. offset at a frequency of 76.6 Hz. Magnetic energy is considered to be non- ionizing radiation.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Bone Growth Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Bone Growth Stimulator should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test Level| Compliance Level| Electromagnetic Environment Guidance

• Electrostatic Discharge (ESD)
• IEC 61000-4-2

|

• ±2kV, ±4kV,
• ±6kV contact
• ±2kV, ±4kV,
• ±8kV air

|

• ±2kV, ±4kV,
• ±6kV contact
• ±2kV, ±4kV,
• ±8kV air

| Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

• Electrical Fast Transient/Burst
• IEC 61000-4-4

| N/A| N/A| N/A
Surge IEC 61000-4-5| N/A| N/A| N/A
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11| N/A| N/A| N/A

• Power Frequency (50/60Hz)
• Magnetic Fields IEC 61000-4-8

| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT __ is the a.c mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The Bone Growth Stimulator is intended for use in the electromagnetic environment specified below. The customer or the user of the Bone Growth Stimulator should assure that it is used in such an environment.
Immunity Test| IEC 60601 Test Level| Compliance Level| Electromagnetic Environment Guidance

• Conducted RF
• IEC 61000-
• 4-6

|

• 3 Vrms
• 150 kHz to
• 80 MHz

| 3V|

• Portable and mobile RF communications equipment should be used no closer to any part of the Bone Growth Stimulator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

• Recommended separation distance: ****

• d =[ 3.5 ]√P 150 KHz to 80 MHz V1 ****

• d =[3.5]√P 80 MHz to 800 MHz E1

• d =[ 7 ]√P 800 MHz to 2.5 GHz E1

• where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

• Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b

• Interference may occur in the vicinity of equipment marked with the following symbol:

• Radiated RF

• IEC 61000-

• 4-3

|

• 3V/m
• 80 MHz to
• 2.5 GHz

| 3 V/m

• NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies
• NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Bone Growth Stimulator is used exceeds the applicable RF compliance level above, the Bone Growth Stimulator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Bone Growth Stimulator.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

Recommended separation distances between portable and mobile RF communications equipment and the Bone Growth Stimulator

The Bone Growth Stimulator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Bone Growth Stimulator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Bone Growth Stimulator as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter| Separation distance according to frequency of transmitter m
150 KHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2.5 GHz
W| d =[ 3.5 ]√P V1| d =[ 3.5 ]√P E1| d =[ 7 ]√P E1
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23

• For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
• NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
• NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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 and Seventieth (270th) treatment.

Product Specifications

Manufacturer| DJO, LLC • 5919 Sea Otter Place, Suite 200, Carlsbad, CA 92010 USA
---|---
Model Types| OL1000 & OL1000 SC
Operating Conditions|

• Temperatures : +41°F (5°C) to +104°F (40°C) Relative Humidity : 15% to 93% non-condensing Atmospheric Pressure : 700hPa to 1060 hPa Altitude : Maximum of 3000m
• NOTE: CMF Bone Growth Stimulators must remain at Operating Temperature one hour prior to use.

Transport and Storage Conditions| Temperatures : -13°F (-25°C ) without relative humidity control, up to 158°F (70°C)

Relative Humidity : 15% – 93% non-condensing Atmospheric Pressure : 500 hPa to 1060 hPa

Dimensions| 11 in x 12 in x 1.5 in (28 cm x 31 cm x 4 cm)
Weight| 2.0 lbs (0.9 kg)
Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Degree of Protection Against Ingress of Liquids| IP22. Protected against solid foreign objects of 12.5mm dia and greater. Protected against vertically falling water drops when enclosure tilted up to 15°.
Degree of Protection Against Electric Shock| TYPE BF Applied Part
Power Supply| Battery operated, replaceable, 9 volts direct current.

Battery operated device (9V standard battery), not to use lithium batteries.

Mode of Operation| Short time continuous operation, 30 minutes per day
Electromagnetic Compatibility (EMC) Electromagnetic Immunity (EMI)| These products are in conformity with Directive 89/336/EEC.
No effect from lint, dust, light.
This device is not intended for use in an Oxygen Rich Environment.
Degree of Protection against Electric Shock: internally powered ME equipment.
Expected Service Life is 270 days from initial use.
Expected shelf life is 2.5 years.
No Sterilization is required.

• DJO, LLC
• 5919 Sea Otter Place Suite 200 Carlsbad, CA 92010 USA
• MDSS GmbH Schiffgraben 41 30175 Hannover Germany
• © 2022 DJO, LLC Printed in the USA
• 13-2104 Rev K 2022-9-26

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