BIONICARE KNEE SYSTEM OACTIVE QUICK START GUIDE - VQ OrthoCare

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BIONICARE KNEE SYSTEM OACTIVE 2QUICK START GUIDE

Congratulations on your BioniCare Knee System—the only non-invasive treatment for osteoarthritis of the kneethat improves the knee, defers knee replacement and reduces medications!The BioniCare Knee System involves the use of a therapeutic electrical current that mimics the signal of a healthyknee to treat osteoarthritis. It takes daily use over several weeks to feel a reduction in pain and an improvement infunctioning. The device should be worn subsensory (you should not be able to feel it). Most patients will NOT FEELANYTHING even at the maximum intensity. You can check the device to make sure it is sending the signal out, but youwill know that it is working by the improvements you see in your knee.If you have any questions about the use of the BioniCare Knee System,please call our Patient Care Department at 800.452.7993YOUR OACTIVE 2 BIONICARE KNEE SYSTEM INCLUDES:1.2.3.4.5.6.7.8.9.10.11.BioniCare WrapThigh ElectrodeKnee Electrode1BioniCare Device(2) Rechargeable BatteriesLead WireBattery ChargerBioniCare Device Holster2Brace Thigh LinerBrace Knee WrapBluetooth Dongle (optional)34567911810

STEP 1: TAKE THESE ITEMS41aSTEP: Press battery doorup to open and lift off. INSERTbattery into the device. Slide doorLEAD WIRE PORTto close.5STEP 1b: INSERT lead wire intothe BioniCare deviceLEAD WIRE1 BioniCare Device1 RechargeableBattery6SIDE VIEWTHIS SIDE UP1 Lead wireFRONTSIDE VIEW BACKSTEP 2: TAKE THESE ITEMSBACK VIEWSTEPBACK VIEW3: Attach knee wrap to brace. With the pointedend of the condyle pocket pointed towards the kneecap,pull the wrap over the condyle cap.9Brace Thigh Liner2Thigh ElectrodeFRONTCONDYLE CUP310FRONTBrace Knee WrapKnee ElectrodeMake sure the condyle cup/pad is completely covered by the wrap.

STEP 4: Replace thigh liner by removing the standardSTEP 5a: Apply thigh electrode to thigh liner.OActive 2 liner from the brace and replacing it with theone included in the BioniCare kit.Peel WHITE backing off thigh electrode and adhereelectrode to the center of the thigh liner with whiteside against liner and black side facing out.BIONICAREOACTIVE 2LINEROACTIVE 2LINEROACTIVE 2LINER WHITEBACKING WHITESIDEPencil-alt NOTE: These steps may have been done for youduring your fitting by a technician.STEP 5b: Peel CLEAR backing off the thigh electrode. NOTE: The white side of the electrode should be against theliner and the black side should be against the skin.CLEAR PLASTIC BLACK SIDE TIP: Make sure that the wire extends toward the top of the liner.6STEP : Apply brace to leg, as detailed in braceapplication instructions. Leave knee wrap open.

7STEP : Apply knee electrode. Peel clear plasticbacking from knee electrode. With knee at 45 , adhereelectrode to knee by first placing center section overkneecap with wire extending down as shown. Centerthe round area in the middle of the electrode over thekneecap. Then press entire electrode firmly to skin.Peel white backing off electrode. The WHITE side ofthe electrode should be against wrap and BLACK sidegoes against the skin.WHITESIDE45 STEP 8: Apply knee wrap around the knee andSTEP 9: Attach red lead wire tip to the knee electrodesecure in front with velcro tab.and the black lead wire tip to the thigh electrode. TIP: You can tuck the lead wire in the brace strapsto route wire upward towards thigh.Match red to red and black to black.

STEP 10: Press middle button to turn on device.STEP 11: Answer the following questions.Press the unlock icon on screen to unlock. TIP: Middle button will also unlock screen.STEP 12: Press play button to start treatment.Increase past 2.0 volts then continue to increaseuntil you feel tingling. Then DECREASE until youno longer feel tingling.Your device will periodically ask 4 questions to chart yourprogress. Press the middle button to answer and the sidebuttons to scroll through answer options.Recommended treatment time in the brace is 30-60 minutes on the first dayand increasing after that as you adjust to wearing the brace. The BioniCaresignal should be worn a minimum of 8-10 hours a day. It can be used in theBioniCare wrap when the brace is not being worn. The more hours you treatwith the BioniCare signal, the sooner you will see improvements in your knee.NOTE: If your device says “OPEN” after you get past 2.0 volts, the device is notconnected correctly or not making good contact. Make sure white side of electrode is against wrap and black gel is againstskin (Thigh Electrode: STEPS 5a and 5b; Knee Electrode: STEPS 7 - 8). Make sure electrodes are stuck to skin (STEPS 6 and 7) and wires are allconnected (STEPS 1B and 9). It’s okay if you do not feel tingling even at 12.0 volts.The BioniCare device is still administering treatment.To save battery life, set treatment at 8.0 volts. If electrodes are old, replace your electrodes.If you cannot get the OPEN error to stop, try the troubleshooting section of themanual or call Patient Care at 800.452.7993.

BIONICARE KNEE WRAP SYSTEMQUICK START GUIDESTEP 1: TAKE THESE ITEMS451ASTEP: Press battery doorup to open and lift off. INSERTbattery into the device. Slide doorLEAD WIRE PORTto close.STEP 1B: INSERT lead wire intothe BioniCare deviceLEAD WIRE1 BioniCare Device1 RechargeableBattery6SIDE VIEWTHIS SIDE UP1 Lead wireFRONTSIDE VIEW BACKBACK VIEWBACK VIEW

STEP 3: Lay Wrap on table with 1 KNEE and 1 THIGHSTEP 2: TAKE THESE ITEMSelectrode.122 Thigh Electrodes1 BioniCare Wrap32 Knee ElectrodesSTEP 4: Peel WHITE backing off knee electrode andSTEP 5: Peel CLEAR backing off each electrode.apply within outlines on BioniCare Wrap.THIGH ELECTRODEGOES HEREKNEEELECTRODEREPEAT: Repeat process for thigh electrode NOTE: The white side of the electrode should be againstthe wrap and the black side goes against the skin. TIP: KEEP plastic sheets to reapply on electrodes after each use.

STEP 6: Apply BioniCare Wrap to knee.STEP 7: Wrap top and bottom straps around leg.WIREKNEETHIGHSIDE VIEWCALFKNEEWIRELine up circle of knee electrode over your kneecap and thighelectrode over your thigh with electrodes sticking to skin.Wires should extend downwardand upward from the BioniCare Wrap.STEP 8: Attach red lead wire tip to the kneeSTEP 9: Press middle button to turn on device. Presselectrode and the black lead wire tip to the thighelectrode.the unlock icon on screen to unlock. Match red to red and black to black. TIP: Middle button will also unlock screen.

STEP 10: Answer the following questions.STEP 11: Press play button to start treatment.Your device will periodically ask 4 questions to chart yourprogress. Press the middle button to answer and the sidebuttons to scroll through answer options.STEP12:Increase past 2.0 volts then continue toincrease until you feel tingling. Then DECREASE untilyou no longer feel tingling.Recommended treatment time is a minimum of 8 hours aday. However, the more hours you treat with the BioniCareSystem, the sooner you will see improvements in your knee.NOTE: If your device says “OPEN” after you get past 2.0 volts, thedevice is not connected correctly or not making good contact. It’s okay if you do not feel tingling even at 12.0 volts.The BioniCare device is still administering treatment.To save battery life, set treatment at 8.0 volts. Make sure white side of electrode is against wrap and black gel isagainst skin (STEPS 4-5). Make sure electrodes are stuck to skin (STEP 6) and wires are allconnected (STEPS 1B and 8). If electrodes are old, replace your electrodes.If you cannot get the OPEN error to stop, try the troubleshootingsection of the manual or call Patient Care at 800.452.7993.

BIONICARE SYSTEM OACTIVE 2 REMOVAL STEPSBIONICARE WRAP SYSTEM REMOVAL STEPSSTEP 1: Detach knee wrap and carefullypeel from knee. Place clear plastic backingonto knee electrode for protection whennot in use.STEP 1: Detach BioniCare Wrap andcarefully peel from knee.STEP 2: Place clear plastic backing ontoknee and thigh electrodes for protectionwhen not in use.STEP 2: Remove brace. Place clear plasticbacking onto thigh electrode.NOTE: There is no need to remove theelectrodes from the BioniCare Wrap uponremoval. Leave the electrodes in placeand cover the electrodes with the clearbacking to keep the electrodes clean andto prevent them from prematurely drying.NOTE: There is no need to remove theelectrodes from the knee wrap uponremoval. Leave the electrodes in placeand cover the electrodes with the clearbacking to keep the electrodes clean andto prevent them from prematurely drying.SIDE VIEWCARE AND MAINTENANCEELECTRODES Always replace clear plastic backings on electrodes after each use. Do not use alcohol to clean skin surface. Electrodes should only be used on dry, clean, unbroken skin surfaces. Prior toBioniCare Wrap application wash skin with soap and water and completely dry. Do not apply skin lotion prior to application of BioniCare Wrap. Do not trim electrodes, as cut edges may affect the even distribution ofstimulation. Remove BioniCare Wrap before showering. If you experience symptoms of skin irritation while using the BioniCare system,discontinue use immediately and contact VQ OrthoCare’s Patient CareDepartment at 800.452.7993, or consult your BioniCare provider or healthcarepractitioner.CAUTIONElectrodes should be discarded and replaced if damaged or if they show signsof wear. If in doubt about the integrity or proper function of any electrode,replace it before proceeding with treatment.BIONICARE WRAP AND OACTIVE 2 LINERSTo clean the wrap and liners, the electrodes should first be removed. The wrapand liners should be hand washed in cold water with mild detergent. Rinsethoroughly and air dry (do not machine dry). Never machine wash the wraps andliners. Never use bleach, fabric softener, or harsh detergents.FOR QUESTIONS OR TROUBLESHOOTING PLEASE CALL800.452.7993 TO SPEAK TO A BIONICARE REPRESENTATIVELIKE US ON FACEBOOKFOLLOW US ON TWITTERFOLLOW US ON INSTAGRAM@BioniCare@BioniCare@BioniCare

INDICATIONS: The BioniCare Knee System is indicated foruse as an adjunctive therapy in reducing the level of pain andsymptoms associated with osteoarthritis of the knee and foroverall improvement of the knee as assessed by the Physician’sGlobal Evaluation (clinical studies).CONTRAINDICATIONS Do not use the BioniCare Knee System for any electrode placement that applies current to the carotid sinus (neck) region. Do not use the BioniCare Knee System for any electrode placement that causes current to flow transcerebrally (through thehead). Do not use the BioniCare Knee System when pain syndromesare undiagnosed until etiology is established.PRECAUTIONS: Isolated cases of skin irritation may occur atthe site of electrode placement following long-term application.ADVERSE REACTIONS: Skin irritation and electrode burnsare potential adverse reactions. Patients with skin irritation/reactions should be monitored.WARNINGS The BioniCare Knee System must be used only as prescribedand applied only to the knee. Patients with demand style cardiac pacemakers shouldconsult with their physician prior to use of this system. The safety of the BioniCare Knee System for use duringpregnancy has not been established. The BioniCare Knee System is not effective for pain of centralorigin (including headache). Use only under the continued supervision of a physician. Keep out of reach of children. Electronic monitoring equipment (such as ECG monitors andECG alarms) may not operate properly when the BioniCareKnee Device is in use.NOTES:WARNINGS: If you experience pain, swelling, sensationchanges, or unusual reactions while using this product, contactVQ OrthoCare’s Patient Care department at 800.452.7993 orconsult a physician.CAUTION: Federal law restricts this device to sale by or on theorder of a practitioner licensed by the law of the State in whichhe/she practices to use or order the use of the device.BIONICARE KNEE SYSTEMQUICK START GUIDEFOR OTHER LANGUAGES PLEASE FOLLOW THESE LINKS:VERSION EN ESPAÑOLbuff.ly/2R7AZSb1390 Decision Street, Suite A Vista, CA 92081 USAEU Manufacturer:18011 Mitchell South, Suite A Irvine, CA 92614 USA800.266.6969 www.vqorthocare.comEMERGO EUROPEPrinsessegracht 202514 AP The HagueThe NetherlandsVERSION FRANÇAISEbuff.ly/2WiODpo 2019 VisionQuest Industries, Inc.VQO511977REVD

The BioniCare Knee System involves the use of a therapeutic electrical current that mimics the signal of a healthy knee to treat osteoarthritis. It takes daily use over several weeks to feel a reduction in pain and an improvement in functioning. The device should be worn subsensory (you should not be able to feel it).