patient’s guide to obtaining an orthocor™ active knee system™ · orthocor medical, inc. 4848...

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OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF (7354) Fax: 888.314.8870 Email: [email protected] www.orthocormedical.com Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ To obtain an OrthoCor Active Knee System please follow the steps below: 1. Print out this entire patient guide, which includes: a. OrthoCor Active Knee System Physician Written Order Form b. Frequently Asked Questions (FAQs) c. OrthoCor Reference Guide d. OrthoCor Patient Brochure 2. Complete the patient portion of the Physician Written Order Form with your contact information. 3. Schedule an appointment with your doctor or orthopedist. 4. Bring all the documents to the appointment to discuss with your doctor. 5. Have the receptionist at the clinic fill out the clinic information portion of the Physician Written Order Form. 6. Once approved, your doctor must fill out the medical necessity portion of the Physician Written Order Form. All medical necessity portions must be signed by your doctor to be valid AND clinical notes must be attached to the form. 7. Send the Physician Written Order Form and clinical notes to OrthoCor Medical via mail or fax: OrthoCor Medical Inc. ATTN: Orders 80 South 8th St Ste 4848 Minneapolis, MN 55402 Fax: (888) 314-8870 8. Upon receipt of the documents, OrthoCor will process the order. You should then expect a call from our insurance partner, who will explain your coverage benefits and fulfill your order. To maximize your coverage benefits, please ensure that all information is complete and accurate. For questions about your order, please email [email protected] or call 877.678.RELIEF (7354).

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Page 1: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

     

OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF (7354) Fax: 888.314.8870 Email: [email protected] www.orthocormedical.com

Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™

To obtain an OrthoCor Active Knee System please follow the steps below:

1. Print out this entire patient guide, which includes: a. OrthoCor Active Knee System Physician Written Order Form b. Frequently Asked Questions (FAQs) c. OrthoCor Reference Guide d. OrthoCor Patient Brochure

2. Complete the patient portion of the Physician Written Order Form with your contact information.

3. Schedule an appointment with your doctor or orthopedist.

4. Bring all the documents to the appointment to discuss with your doctor.

5. Have the receptionist at the clinic fill out the clinic information portion of the Physician Written Order Form.

6. Once approved, your doctor must fill out the medical necessity portion of the Physician Written Order Form.

All medical necessity portions must be signed by your doctor to be valid AND clinical notes must be attached to the form.

7. Send the Physician Written Order Form and clinical notes to OrthoCor Medical via mail or fax: OrthoCor Medical Inc. ATTN: Orders 80 South 8th St Ste 4848 Minneapolis, MN 55402 Fax: (888) 314-8870

8. Upon receipt of the documents, OrthoCor will process the order. You should then expect a call from our insurance partner, who will explain your coverage benefits and fulfill your order. To maximize your coverage benefits, please ensure that all information is complete and accurate. For questions about your order, please email [email protected] or call 877.678.RELIEF (7354).

Page 2: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

1404 Rev. D

ORTHOCOR ACTIVE KNEE SYSTEM – PHYSICIAN WRITTEN ORDER Please provide the information requested below and complete the form in full.

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PATIENT DOB ___ ___ / ___ ___ / ___ ___ Sex_____(M/F)

PATIENT NAME______________________________________

ADDRESS___________________________________________

CITY _______________________________________________

STATE ____ ____ ZIP____ ____ ____ ____ ____

MOBILE PHONE( ___ ___ ___ ) ___ ___ ___ - ___ ___ ___ ___

PHONE(___ ____ ____) ____ ____ ____ - ____ ____ ____ ____

INSURANCE WORKER’S COMPENSATION

DATE OF INJURY: ____ ____ / ____ ____ / ____ ____

INSURANCE_________________________________________

INSURANCE POLICY ID/CLAIM # ____________________________________________________

GROUP # ___________________________________________

INSURANCE PHONE (_______) ___ ___ ___ -___ ___ ___ ___

PHYSICIAN NAME _____________________________________

FACILITY NAME _______________________________________

FACILITY ADDRESS ___________________________________

CITY ________________________________________________

STATE ____ ____ ZIP ____ ____ ____ ____ ____

PHONE (___ ____ ____) ____ ____ ____ - ____ ____ ____ ____

FAX (___ ____ ____) ____ ____ ____ - ____ ____ ____ ____

NPI # ________________________________________________

OFFICE CONTACT ____________________________________

PLEASE FAX OR E-MAIL COMPLETED FORM TO ORTHOCOR MEDICAL Fax: (888) 314-8870 Email: [email protected]

For any inquiries, please call:

OrthoCor Medical - 1-877-678-7354

Please Complete All Appropriate Boxes

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dic

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ss

ity

INITIAL ORDER (CHECK 2) ACTIVE KNEE SYSTEM - E0761:

1.) LENGTH OF NEED: __99___ 99=Lifetime IF OTHER PLEASE SPECIFY _______

2.) ACTIVE KNEE SYSTEM: QUANTITY OF _1/999_ OTHER QUANTITY: ________/999

CONTINUOUS NEED (CHECK 2) ORTHOPODS – A4595:

1.) LENGTH OF NEED: __99___ 99=Lifetime IF OTHER PLEASE SPECIFY _______

2.) ORTHOPODS: QUANTITY OF 15 PER MONTH OTHER QUANTITY: ________/PER MONTH

SIZE: DISTANCE AROUND CENTER OF KNEE MEDIUM 16-18” LARGE 18-20” X-LARGE 20-22”

DIAGNOSIS CODES (ICD-9): (M17.10) Osteoarthritis (M22.40) Chondromalacia Patella (M25.469) Joint Effusion Lower Leg

(M65.9) Synovitis and Tenosynovitis (M06.9) Rheumatoid Arthritis (M25.569) Joint Pain Lower Leg

Other________________________

THE FOLLOWING TREATMENTS HAVE NOT BEEN SUCCESSFUL FOR THIS PATIENT:

Physical Therapy Viscosupplementation Injections OA (unloader) Bracing

Drug Therapy(ies) Cortisone Injections Other _______ _______ _____

I certify that I am the physician identified in this form. I have reviewed all sections of the physician’s written order. Any statement on my letterhead attached hereto has been reviewed and signed by me. I certify that the medical necessity information is true, accurate and complete to the best of my

knowledge. I certify that the patient/caregiver is capable and has successfully completed training in utilizing the products prescribed in this written order. The patient’s record contains supporting documentation which substantiates the utilization and medical necessity of the products listed and physician notes will be provided to an authorized distributor upon request. I understand any falsification, omission or concealment of material fact may subject me

to civil or criminal liability. A copy of this order will be retained as part of the patient’s medical record. By faxing this form you are acknowledging that the patient is aware that a representative from the authorized distributor may be contacting them for any additional information to process this order.

PHYSICIAN’S SIGNATURE:___________________________________________________DATE____ ____ / ____ ____ / ____ ____ signature and date stamps are not acceptable

PHYSICIAN’S PRINTED NAME: ________________________________________________________________________________ *Please attach any clinical notes to expedite this request.

SALES AGENCY: ________________________________________SALES REP: ________________________________________

Page 3: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

     

OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF (7354) Fax: 888.314.8870 Email: [email protected] www.orthocormedical.com

 

OrthoCor™ Active Knee System™

Frequently Asked Questions

Q: What is the cost of the OrthoCor Active Knee System?

A: Please contact OrthoCor Medical at 877-678-RELIEF (7354) for pricing.

Q: Is it FDA approved?

A: The OrthoCor Active Knee System is FDA cleared for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft-tissue. It is also used to treat patients with muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis.

Q: Where can I purchase the OrthoCor Active Knee System?

A: The OrthoCor Active Knee System may be purchased through our partner clinics, or directly from OrthoCor with a prescription.

Q: What type of knee pain does the OrthoCor Active Knee System treat?

A: The following conditions have been successfully treated using the OrthoCor Active Knee System: chronic pain, arthritis, swelling, post-operative pain, strains and sprains.

Q: How does PEMF work to reduce the pain and edema?

A: PEMF is a low-level, time varying electromagnetic field that has been proven to effectively reduce pain and edema (swelling) in superficial soft tissue. PEMF helps to activate the body’s natural anti-inflammatory and recovery response.

Q: Is the device covered by insurance?

A: OrthoCor has national coverage with private insurers. The OrthoCor Active Knee System is also eligible for Flex & HSA. Please contact us at 877-678-RELIEF (7354) with additional questions.

Q: What are OrthoPods?

A: OrthoPods are single-use treatment packets that activate the PEMF therapy. Each OrthoCor Active Knee System comes with a 15-treatment supply of OrthoPods. Refill OrthoPods can be ordered directly through OrthoCor.

Q: What is the cost of OrthoPod refills?

A: Please contact OrthoCor Medical at 877-678-RELIEF (7354) for pricing. Each box contains a 15-treatment supply of OrthoPods. OrthoPod refills can be purchased from OrthoCor Medical for home delivery.

Page 4: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

     

OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF (7354) Fax: 888.314.8870 Email: [email protected] www.orthocormedical.com

 

Q: Are there different sizes?

A: The OrthoCor Active Knee System comes in 3 different sizes (Medium, Large and Extra-Large) and can be worn on both the left or right knee.

Q: How do I determine my size?

A: Measure the distance around the center of the knee.

Medium Large X-Large

16-18” 18-20” 20-22”

Q: Why do patients need prescriptions to purchase the OrthoCor Active Knee System?

A: The OrthoCor Active Knee System is a Class III medical device and per FDA regulations, it must be sold by or on the order of a licensed health care practitioner.

Q: Does the OrthoCor Active Knee System use batteries?

A: The OrthoCor Active Knee System uses a rechargeable battery and comes with an adapter to recharge.

Q: How long does the therapy last?

A: Each therapy session lasts 2 hours. The device will automatically shut off after the 2-hour therapy has completed.

Q: Can I try it before I buy it?

A: OrthoCor does not offer trials.

Q: What is the warranty?

A: The OrthoCor Active Knee System has a one-year manufacturer’s warranty on any defects.

Q: What is the return policy?

A: OrthoCor does not accept returns nor offer refunds for purchased products. However, the OrthoCor Active Knee System has a one-year limited warranty for manufacturing defects.

Q: What are the indications for use?

A: The OrthoCor Active Knee System is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue. It is also used to treat patients with minor muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis.

Q: How do I find out information about ordering?

A: Please email [email protected] or call 877.678.RELIEF (7354) for information regarding your order.

Page 5: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

Contraindications • Donotuseonpatientswithacardiacpacemaker,cardioverterdefibrillator,

neurostimulator,infusionpumporanyactivemedicalimplant.• DonotuseonpatientswhohaveANYimplantedmetallicleadoranytypeofwirecoil

implant,oranyimplantedsystemthatmaycontainalead.• Donotuseonpatientswhoareormaybepregnant.• Donotuseonpatientswithanopenwoundattheareaofapplication.• Donotuseonpatientsnotfullyawaretothesensationofheat.• Donotuseonpatientswithpoorcirculationorheartdisease.• Donotuseonpatientswithdiabetes.• Donotuseonpatientsundertheageof18orindividualswithopenbone

growthplates.

Warnings-WARNING:Thisdeviceshouldbeusedunderthecontinuedsupervisionofalicensedhealthcarepractitioner.-WARNING:THISPRODUCTCANCAUSEBURNSANDSKINIRRITATION.Yourriskofburningincreasesas

youage.Checkskinfrequentlyduringuseforsignsofskinirritationorburns.-WARNING:Usecarefully.Removeimmediatelyifthekneebecomestoohotordiscomfortoccurs.-WARNING:Donotusewithpainrubs,medicatedlotions,creamsorointments.-WARNING:Donotusewithotherformsofheat.Thismaycauseburns.-WARNING:Precautionshouldbetakenpriortousingthisdeviceonpatientswithneopreneallergies.-WARNING:Precautionshouldbetakenwhenusingthisdeviceontheelderlyorincapacitatedpersons.

TheunattendeduseofOrthoPodsbythesepatientsmaybedangerous.-WARNING:Precautionshouldbetakenwhenusingthisdeviceonpatientswithsensitiveskin.Ifthepatient

experiencesskinirritation,discontinuetheuseofthedeviceandconsultyourlicensedhealthcarepractitionerbeforeusingtheOrthoCorActiveKneeSystemagain.

-WARNING:Equipmentisnotsuitableforuseinthepresenceofaflammableanestheticmixturewithairorwithoxygenornitrousoxideoroxygenenrichedatmospheres.

-WARNING:DonotapplytheOrthoPodsdirectlytobareskinasitmaycauseburns.-WARNING:DonotopenorpuncturetheOrthoPods.-WARNING:DonotletthecontentsoftheOrthoPodsmakedirectcontactwithyourmouthoreyes.Immediately

andthoroughlyrinsewithcleanwater,ifcontactwithOrthoPods’contentsoccurs.-WARNING:DonotingestthecontentsoftheOrthoPods.IMMEDIATELYCALLthenearestPoisonControl

CenterifOrthoPods’contentsareingested.-WARNING:Donotover-tightentheKneeOrthoCuffasthismayrestrictbloodflowandresultininjury.

Indications for use• TheOrthoCorActiveKneeSystemisindicatedforadjunctiveuseinthepalliative

treatmentofpost-operativepainandedemainsuperficialsofttissue.

• Temporarilyrelievesminormuscleandjointachesandpainassociatedwithoverexertion,strains,sprains,andarthritis.

Quick Reference Guide to the OrthoCor Active Knee System

OrthoCorMedical,Inc.4848IDSCenter80South8thStreetMinneapolis,Minnesota55402USA

Phone:877-678-RELIEF(7354)Fax:888.314.8870Email:[email protected]

Page 6: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

Cautions-CAUTION:Usethisdeviceonlyintheprescribedmannerandfortheprescribeddiagnosis.-CAUTION:KEEPAWAYFROMWATER.Useindryenvironment.-CAUTION:Thedeviceisnotindicatedfortreatmentofdeeptissuesuchasinternalorgans.-CAUTION:DonotusewhiletheOrthoCorActiveKneeSystemischarging.-CAUTION:DonotmachinewashtheOrthoCorActiveKneeSystem.-CAUTION:DonotcrushtheOrthoSourceortheKneeOrthoCuffasthismaydamagetheelectronics.-CAUTION:DonotreusetheOrthoPods.-CAUTION:RemovingtheOrthoPodswillstopthetreatment.-CAUTION:TheACadaptermustbedisconnectedfromtheOrthoSourcefortreatmenttooccur.-CAUTION:Keepoutofreachofchildren.-CAUTION:Forexternaluseonly.-CAUTION:NEVERheattheOrthoCorActiveKneeSystemorOrthoPodsinthemicrowaveasthesystem

couldcatchonfire.

OrthoCorMedical,Inc.4848IDSCenter80South8thStreetMinneapolis,Minnesota55402USA

Phone:877-678-RELIEF(7354)Fax:888.314.8870Email:[email protected]#1068-01revA

Page 7: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

After using the

OrthoCor Active Knee System, I’m happy to say

that I’m back running. In fact, the combination of running

and a healthy diet has allowed me to lose 22

pounds!

healthy knees

”©2014 OrthoCor Medical, Inc. 08/14 Caution: Federal law restricts this device to sale by or on the order of a health care practitioner. Brochure #: 00158 rev G

OrthoCor Medical, Inc.4848 IDS Center80 South Eighth StreetMinneapolis, MN 55402

bill, former professional baseball playerexcelsior, minnesota

active knees

[email protected]

Save knees and trees. Pass this brochure along to someone you know with knee pain.

The Active Knee System requires a prescription.

QUESTIONS?

A new, wearable anddrug-free way to manage your knee pain.

INSURANCE COVERAGETo help maximize your benefits, OrthoCor has national coverage with workers’ compensation and several national providers.

Ask your doctor about the Active Knee System.

1) F.R. Nelson, R. Zvirgulis, A.A. Pilla, “Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study,” Rheumatology International, March 2012.2) Rohde, “Effects of Pulsed Electromagnetic Fields on Interleukin-1 and Postoperative Pain: A Double-Blind Placebo-Controlled, Pilot Study in Breast Reduction Patients,” Am Soc of Plas Surg, vol. 125, pp. 1620-1629, 2010.3) A.A. Pilla, “State of the Art in Electromagnetic Therapeutics: Soft Tissue Applications,” Electricity and Magnetism in Biology and Medicine, F Ber-sani, ed., Plenum, NY, 1999, pp. 871-874.

CLINICAL STUDIES

For more info visit www.orthocormedical.com

powered by pemfknee active systemtm

Page 8: Patient’s Guide to Obtaining an OrthoCor™ Active Knee System™ · OrthoCor Medical, Inc. 4848 IDS Center 80 South 8th Street Minneapolis, Minnesota 55402 USA Phone: 877-678-RELIEF

The OrthoCor™ Active Knee System™ is the only device on the market with OrthoCor’s patented Pulsed Electromagnetic Field (PEMF) therapy,one of the most advanced restorative therapiesavailable today.

BENEFITS Drug-free pain relief

Wearable design for therapy on the go

Noninvasive and easy-to-use

Helps return you to an active lifestyle

INSIDE THE ACTIVE KNEE SYSTEMInside every Active Knee System is the OrthoCor, a powerful microchip that delivers PEMF directly into your knee. PEMF works at the cellular level of the knee, and has been shown to stimulate the production of nitric oxide, a process fundamental to healing in living tissue.

CLINICALLY PROVEN RESULTS60% reduction in chronic knee pain1

55% reduction in pain medication use2

7x faster reduction in acute injury induced edema (swelling)3

OrthoSource™

Rechargeable OrthoCor microchip with 2-hour, automatic shutoff

OrthoDock™

Lightweight, low profile design that fits over or under clothing

OrthoPods™

Patented, penetrating PEMFtherapy for maximum results

OrthoCuff ™

Bilateral, fully adjustable design for ultimate fit and mobility

THE PAIN RELIEF YOU NEED

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POWERED BY PEMF

OrthoCor’s specialized PEMF therapy is clinically proven to provide lasting relief without the use of pain medication or invasive procedures. PEMF works at the source of injuries, and helps accelerate your body’s natural anti-inflammatory and recovery responses.

PEMF has treated these conditions successfully:

PEMF Treatment Days

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PEMF Effect on Knee Osteoarthritis Pain 1

www.orthocormedical.com

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Chronic Pain

Arthritis

Swelling

Post-operative Pain