NuVasive PRECICE ERC1 Quick Reference Manual

Brand: NuVasive

Model: PRECICE ERC1

Type: Quick Reference Manual

External Remote Controller (ERC) Quick Reference Guide

ERC1 PROGRAMMING

Treatment Area

• Check that there is a close electrical outlet to plug in the ERC.

• Make sure there are no electronic devices within two feet.

• Remove ALL metal items from where you will be doing the treatment.

Timing

• It will take approximately seven minutes for every 1 mm of lengthening.

How to power the ERC

• When the ERC is connected and plugged in, the screen will

light up and the controller will perform a self-test.

• After self-test is completed, the NuVasive® logo will appear.

USING THE ERC FOR TREATMENT

1. Enter Physician Access Password

• Select F9 to prompt the password screen.

• Select the ENTER (appears as “ENT ” on screen) button when prompted.

– The background will turn dark to indicate that it has been selected.

• Use the keypad to enter the password provided by NuVasive and select the ENTER button.

2. Physician Parameter Setup

• Select the upper left arrow to access the previous physician parameter data.

• Select the lower left arrow to advance to the next screen.

• Select the upper right arrow labeled “Reset Patient Data.”

WARNING: This will erase the patient data previously programmed in the ERC.

• Select the upper right arrow (“YES”) to reset patient data.

1 Right Handle

2 Left Handle

3 GREEN Extend Push Button with the arrows

pointing away from each other ( ) may be

used to make the implanted PRECICE® nail longer.

4 YELLOW Retract Push Button with the arrows

pointing toward each other ( ) may be

used to make the implanted PRECICE nail shorter.

5 Locating Window is used to line up the ERC with

the internal magnet.

3. Nail Approach

• Select “Antegrade” or “Retrograde” by using upper or lower right arrows.

• Select the lower left arrow to advance to the next screen.

17-NUVA-0071www.nuvasive.com

To order, please contact your NuVasive

Sales Consultant or Customer Service Representative today at:

NuVasive, Inc. 7475 Lusk Blvd., San Diego, CA 92121 USA • phone: 800-475-9131 fax: 800-475-9134

NuVasive Specialized Orthopedics 101 Enterprise, Suite 100, Aliso Viejo, CA 92656 USA

phone: 949-837-3600 fax: 949-837-3664

Medpace Medical Device B.V. Maastrichterlaan 127-129, 6291 EN Vaals, Netherlands

trademark of NuVasive Specialized Orthopedics. in the U.S. and may be registered in other countries. NuVasive Specialized Orthopedics is a trademark of NuVasive, Inc.

REPEC

USING THE ERC FOR TREATMENT (CONTINUED)

4. Enter Max Daily Distraction Details

• Enter the prescribed length for the Max Distraction per day.

– Max Distraction: the maximum distraction distance that a patient may perform in a 24-hour

period. This value may be set from 0.00 to 9.99 mm/day. If this value is set to 0.00 mm/day, the

ERC will distract without limits.

– Use small arrows at the bottom of the screen to adjust total distraction length.

• Enter the prescribed total distraction length.

– Edit this value to correlate the actual implant distraction measured on a radiograph to the value

displayed on the ERC. This value may be adjusted from 0.00 to 180 mm. If this value is set to

0.00 mm total, the ERC will distract without limits.

– Select the lower left arrow to advance to the next screen.

5. Set Patient Access Password

• This is the password value that the patient must enter each time the ERC is powered on. The

Patient Access Password may be set from 0 to 999999999. If the Patient Access Password is set

to 0, the “Patient Access Password” screen is bypassed and users will have immediate access to

the ERC. No password entry is required.

6. Set Date and Time

• It is important to enter the current date and time for data logging to be accurate.

• The two options are MM/DD (month/date) or DD/MM (date/month). To edit, use the bottom

arrow to position the dashed cursor box around the “Date Format.”

• Press the ENTER button to select.

– The background will turn dark to indicate that it has been selected.

• Press the up or down arrows at the bottom of the screen to toggle through all available options.

• Press the ENTER button again to accept the new setting or press the ESC button to abort the change.

7. Program the Session

• The value shown at the top of the screen is the distraction distance. This is the amount that the ERC

will distract the implant when the distract button is pressed.

• This value may be changed directly by pressing the ENTER button.

– The background will turn dark to indicate that it has been selected.

• Use the F1-F10 buttons to input the desired value.

• Press the ENTER button again to accept the new value, or press the ESC button to abort the change.

– The target distraction distance value may be set from +2.5 mm to -2.5 mm.

• The ERC is now programmed and ready for patient use.

The ERC is used daily after implantation to non-invasively lengthen or shorten the implant to a prescribed length. The PRECICE System is intended for limb lengthening of the femur and tibia. Please refer to the

PRECICE IMLL System instructions for use for complete Important Safety Information. Caution: Federal law restricts this device to sale by or on the order of a physician.