NuVasive ERC 3P User manual

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 1of 45
External Remote Controller ERC 3P
Patient Manual
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 2of 45
To Physicians: Reference the External Remote Controller ERC 3P Operator’s Manual and
respective Precice Instructions for Use for clinical set-up and information for healthcare
practitioners. Provide a copy of this External Remote Controller ERC 3P Patient Manual to each
patient and review it with them before treatment. Make sure to record the patient’s prescription
on the next page.
To Patients: Read this entire booklet before you use the ERC 3P. Refer to this booklet at any
time during your treatment. You can also talk to your doctor about any questions you have.
GENERAL CONTACT INFO:
101 ENTERPRISE,SUITE 100 |ALISO VIEJO,CA 92656
PHONE:[phone] |FAX:[phone]

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 3of 45
TABLE OF CONTENTS
1) My Prescription.....................................................................................................................................................4
2) SYMBOL DEFINITIONS....................................................................................................................................5
3) DEFINITIONS AND GLOSSARY .....................................................................................................................8
4) INDICATIONS FOR USE: Why is Precice Used? ............................................................................................9
5) CONTRAINDICATIONS: Who cannot use the Precice System? .................................................................10
6) WARNINGS AND CAUTIONS: What must you do to avoid serious harm? ..............................................13
7) RISKS: What are the risks of this procedure? ................................................................................................18
8) PRODUCT DESCRIPTION: About your Precice Implant and ERC...........................................................19
9) SMART FEATURES..........................................................................................................................................22
10) ABOUT THE ERC .............................................................................................................................................23
11) How to use the ERC............................................................................................................................................25
12) INSPECTING, CLEANING, STORAGE AND OTHER INFORMATION.................................................36
13) MORE ABOUT YOUR CONDITION .............................................................................................................37
14) TROUBLESHOOTING .....................................................................................................................................38
15) ERROR CODES .................................................................................................................................................39
16) SPECIFICATIONS ............................................................................................................................................41

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 4of 45
1) MY PRESCRIPTION
Date
Implant
Location
Distance Per Session
(example: 0.25mm)
Sessions Per Day
(example: 4 times/day)
Daily Total
(example: 1.00mm)
Where to place the ERC during each session:
(Circle the general location – there will be a specific mark on your leg)
RIGHT LEG
LEFT LEG
IMPLANT #1
£Right Leg
£Left Leg
£Tibia
£Femur
IMPLANT #2
£Only One Implant
£Right Leg
£Left Leg
£Tibia
£Femur
Special Notes (example: always use crutches):
____________________________________________________
Need help? Call:
My Provider:
Phone:
My Doctor:
Phone:
Femur
Femur
Tibia

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 5of 45
2) SYMBOL DEFINITIONS
For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary
For Symbols specific to the ERC 3P reference the table below.
Symbol
Definition
IPX1
The ERC shall experience no harmful effects from
dripping water
Initialization Screen
This screen is used to instruct the user to initialize the ERC
3P prior to therapy when the implant detection sensors are
turned on When this screen is displayed, the ERC 3P
should be placed back into its case with power still turned
on. Metal should not be in the vicinity of the ERC 3P. The
Control Button is then pressed and the ERC 3P will rotate
the magnets in a forward and reverse direction. The ERC
3P is then ready for or continued therapy.
Go Back key: This is a touch screen key that provides a
method to go back to a previous screen or software state
when it is displayed and pressed by the user.
Continue Key: This is a touch screen key that provides a
method to advance to the next screen or software state
when it is displayed and pressed by the user.
Reset Value Key: When displayed, this touch screen key
next to a value displayed allows the user to reset it when it
is pressed.
Clinical Key: This touchscreen key provides a method for
a clinician to access software modes limited to non-
patients. Accessing these modes requires a passcode.
Control Button, Blinking Green: An external button is
used by users to begin therapy, accept parameters entered,
or advance to the software screen.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 6of 45
Control Button, Solid Red: An external button is used by
users to stop therapy at any time.
Alignment Line: This line symbol labeled on the ERC 3P
identifies the center of the ERC 3P magnet lengths. It can
be used as method to align ERC magnets to implant
magnets based on the lines or sutures located on the
patient’s limb.
Alignment Area: This symbol is located within the
Alignment Window over the center bar. It is used to
identify that the location where the implant magnet must
align with the ERC within the Alignment Window.
ERC 3P Position Orientation LEFT with ARROW: This
symbol and labeling indicates the orientation of the ERC
3P relative to the patient. The patient should be able to
view this symbol with arrows pointed toward their feet.
LEFT indicates the left side of the unit is positioned to the
left side of the patient.
ERC 3P Position Orientation RIGHT with ARROW: This
symbol and labeling indicates the orientation of the ERC
3P relative to the patient. The patient should be able to
view this symbol with arrows pointed toward their feet.
RIGHT indicates the right side of the unit is positioned to
the right side of the patient.
Uncoupled Implant Detection: This symbol displayed
indicates that the ERC 3P does not detect implant magnets
or their rotation.
Reposition and realign, then press Go until icon
indicates ERC is connected to the implant.
Coupled Implant Detection: This symbol displayed
indicates the ERC 3P has detected the implant magnet and

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 7of 45
it is properly rotating.
Stalled Implant Detection: This symbol displayed indicates
that the ERC 3P has detected the implant magnet and that
it is unable to complete a full rotation. This is due to
excessive linear force against the implant or weak magnetic
coupling between the ERC and implant magnets.
Realign the ERC using the mark on your skin and the
locating window, alignment lines on the ERC. If the error
code continues to display, please contact NuVasive
Specialized Orthopedics, Inc.
Initialization Button: This touchscreen button is displayed
in Operating Room Mode when the unit is idle. Pressing it
allows the user to begin the Initialization process for the
ERC 3P at a time when it’s convenient.
Initialization Marker: Located on the Progress Bar in
Operating Room Mode, they are used to indicate a point
when therapy will be paused for required initialization.
Green markers to the far right of the progress bar indicate
that no initialization is required during the session.
Anatomic Instruction Screen
The patient’s specific left or right side femur or tibia will
be highlighted on the screen to identify the exact limb with
the PRECICE implant. There are four possible locations
for the implant, only one will be shown with a solid purple
line.
System Error Screen
This screen will appear on the control panel when there
has been an error with the operation of the ERC 3P.
In this figure “123” is given as an example. The screen
may have a different code shown.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 8of 45
3) DEFINITIONS AND GLOSSARY
This section gives definitions to words that are used in this guide.
Active Medical Device: The term "active" means any medical device that needs a power supply.
Power can be supplied by any means including electricity, battery, or gas. Examples of active
devices include ventilators, pacemakers, and patient monitoring devices.
Actuator: The part of the Precice device that can change in length when activated.
Contraindication: Any condition that renders using the Precice system undesirable or
inadvisable.
Coupling: Pairing of the ERC to the Precice device magnetically.
Distract: Distract means to extend or lengthen. The Precice system is used to distract bones.
Retract: Retract means to shorten. The Precice system is used to distract or retract bones.
Electronic Device: This refers to any device that has a power cord that is plugged in for
electrical power or is battery operated. Examples include computers and cell phones.
ERC: ERC refers to External Remote Controller. The ERC is used to adjust the Precice device
that is in your leg from outside of your body. The ERC system consists of the ERC, and Power
Cord.
Femur: The femur is the thigh bone in the leg. It is the largest bone of the body and is situated
between the hip and the knee.
Tibia: The tibia (or shinbone) is the large leg bone between the knee and ankle.
Humerus: The humerus is the upper arm bone. This is the bone located between the
shoulder and elbow joint.
Implant: An implant is a device that is inserted into the body for a period of time.
Intramedullary: Intramedullary refers to being inside the bone.
MRI: MRI refers to Magnetic Resonance Imaging, which is a medical technique to visualize
structures inside the body.
Osteopenia: Osteopenia is a condition where the density of your bone is lower than normal.
Pacemaker: An artificial device for stimulating the heart muscle and regulating its contractions.
Precice Device: The Precice device is the adjustable implant that is implanted into your leg bone
(tibia or femur). It is lengthened by the ERC from outside your body.
Regenerate: Regenerate refers to new growth. In this manual, it refers to new bone tissue
growth.
Stall: This indicates that the ERC is not lengthening properly.
Troubleshooting: The process of solving problems or why something does not operate correctly.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 9of 45
4) INDICATIONS FOR USE: WHY IS PRECICE USED?
The Nuvasive Specialized Orthopedics, Inc. (NSO) External Remote Controller, model ERC
3P, is a portable hand-held device used to non-invasively extend or retract the Precice Family
Systems.
The Indications for Use of the ERC 3P when used with the Precice System (inclusive of
Precice Unyte, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening,
open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport
of long bones.
The Indications for Use of the ERC 3P when used with the Precice Plating System is indicated
for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-
unions of long bones in pediatrics and small stature adult patients.
The Indications for Use of the ERC 3P when used with the Precice Ankle Salvage System is
intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle
Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-
unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device
may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been
achieved.
After your doctor implants the Precice device into your leg, you will use the ERC to make the
device longer. The lengthening phase usually starts 5 days after your surgery. You will make
the Precice device a small amount longer each day (usually about 0.75 to 1 millimeter each
day). This phase of your treatment could last up to 80 days. Your doctor will tell you how
much and how often to adjust the Precice device. Usually once a week you will visit your
doctor to check on your progress. Your doctor may x-ray your leg during these visits. Your
doctor will also tell you to use crutches and avoid putting weight on your leg with the Precice
device. A good result requires your active cooperation and dedication to certain tasks. If you
do not follow your doctor’s instructions, you could seriously harm yourself.
After your leg has reached its goal length, you will stop using the ERC. This will let your bone
heal.
During the consolidation phase, the bone heals. Your bone will change, or regenerate, from a
soft material into hard bone over time. This healing process usually takes about 2 months for
every inch that your bone has been lengthened. During this healing phase, it is very important
that you follow all of your doctor’s instructions. You will continue to see your doctor for
visits, usually once a month.

Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022 Page 10 of 45
5) CONTRAINDICATIONS: WHO CANNOT USE THE PRECICE SYSTEM?
Important Safety Information – Read Before Use!
Please read and consider the information in this guide before deciding on
your treatment.
This section describes the Contraindications for the Precice System. Tell your doctor if you
have any of the listed conditions. Your doctor must not recommend the Precice system for
you if you do. It is important your doctor has your full medical history to recommend the best
way to treat your condition. He or she may recommend something that can be very harmful if
they do not know your medical background.
CONTRAINDICATIONS:
Your doctor will check the following to see if you would be a good fit for the Precice System
(inclusive of Precice IMLL, Precice Unyte, Precice Stryde and Precice Bone Transport):
•Patients with an irregular bone diameter that would prevent insertion of the Precice nail.
•Patients in which the Precice nail would cross joint spaces or open epiphyseal growth plates.
•Patients in which there is an obliterated medullary canal or other conditions that tend to
retard healing such as blood supply limitations, peripheral vascular disease or evidence of
inadequate vascularity.
•Patients unwilling or incapable of following postoperative care instructions.
•Infection or Pathologic conditions of bone such as osteopenia which would impair the ability
to securely fix the device.
•Patients with Gustilo open fracture Classification Grade IIIB or IIIC fractures
•Patients with pre-existing nerve palsies
•Metal allergies and sensitivities.
Precice Bone Transport has the following additional contraindications:
•Patients with maximum bone defect of more than 100 mm.
•Patients with excessive skin damage and inadequate soft tissue covering of the fracture sites.
Please refer to the tables below for contraindications with regard to weight and maximum
distance of the treated limb to the surface of the intramedullary canal.