Orthofix 1114RC R, 1114RC L Subject Manual

Subject Manual For the

Orthofix Rotator Cuff Repair Study

Models 1114RC R/L

Device Patents No.
U.S. 5,743,844
U.S. 6,132,362

Assembled in the United States of America

ASSEMBLED IN

USA

Device Box Components

1 – The RCStim Device
1 – Power Supply
1 – Literature Pack

Orthofix Clinical Helpline: 866-657-7030

Table of Contents

Rotator Cuff Repair Study .........................................................................

Device Information ...................................................................................

How the RCStim Device Works .................................................................

Device Operation .....................................................................................

Daily Treatment Instruction ......................................................................

Visual and Audio Indicators .....................................................................

Device Compliance ...................................................................................

Device Use and Care .................................................................................

Care and Cleaning ....................................................................................

Storage of the Device ...............................................................................

Traveling with the RCStim Device ............................................................

Disposal ...................................................................................................

Service ......................................................................................................

Contraindications .....................................................................................

Warnings ..................................................................................................

Precautions ..............................................................................................

Adverse Effects Summary .........................................................................

Known and Expected Adverse Events .......................................................

Device Symbol Descriptions ......................................................................

The RCStim Device Classifications ............................................................

Compliance Statements ............................................................................

Information regarding Electromagnetic Compatibility

and Immunity ..........................................................................................

1

2

3

4

5

7

8

8

8

9

9

9

10

10

10

10

11

11

12

13

13

14

1

Rotator Cuff Repair Study

Thank you for participating in the Orthofix Rotator Cuff Repair Study. This
study is being conducted to determine if the RCStim device can improve the
healing of medium to full thickness tear rotator cuff injuries after muscle
repair.

The RCStim device has not been approved by the FDA for use in patients who
have undergone rotator cuff repair and its use is considered investigational.
The device used in this study is designed to be centered over the treatment
area so that your rotator cuff muscles will receive an adequate amount of
electromagnetic field generated by the RCStim device. The device comes in

either a right shoulder or a left shoulder model.

Your doctor should have instructed you to use the device for 90 minutes
each day for 6 months. It is very important that you use the RCStim device

each day as your doctor has directed. If you do not use the device correctly,
we may not be able to determine the effects of the treatment on rotator cuff
repair surgery healing.

If you have any questions regarding your device, please contact your doctor’s
office for assistance.

We sincerely thank you for your participation in the Orthofix Rotator Cuff
Repair study.

2

Device Information

The RCStim device is being evaluated an adjunctive therapy for the healing of
the rotator cuff muscles following rotator cuff repair surgery.

Device Description

The RCStim device is an external device that generates a Pulsed
Electromagnetic Field (PEMF) signal as a nonsurgical, prescription treatment
to increase the chances of a successful rotator cuff repair. The device is
lightweight and portable, including a rechargeable battery that allows
freedom of movement during treatment. A Liquid Crystal Display (LCD) and
audible indicators provide important feedback during treatment. See “Device
Operation” for more information.
.

Treatment

Coil

Control

Unit

Adjustment

Strap

LCD

3

How the RCStim Device Works

To enhance rotator cuff repair, PEMF therapy activates and augments the
body’s natural healing process.

The RCStim device contains a Control Unit and a Treatment Coil in one
integrated device. A micro-processor generates the PEMF signal, which is a
highly uniform,
low-energy pulsed electromagnetic field sent from the treatment coil. When
the coil is centered over the treatment area, the therapeutic signal is delivered
through clothing and skin directly to the treatment site.

Device Life

The RCStim device provides 90 minute daily treatments for 6 months.

Putting the RCStim Device on your Shoulder

1. Fasten one end of the elastic strap to the end opposite the control unit.

2. Place the RCStim device so that it is centered over the treatment site (left or
right shoulder). The control unit should be in front and visible to the patient.

3. Bring the elastic strap around the body under the opposite arm and fasten
on the end of the device next to the control unit.

4. If strap adjustment is needed, loosen or tighten the strap until it feels
secure and comfortable.