NuVasive ERC 4P User manual

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 1of 54
External Remote Controller ERC 4P
Patient Manual

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 2of 54
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.
To Physicians: Reference the PRECICE ERC Operator’s Manual and PRECICE Instructions
for Use for clinical set-up and information for healthcare practitioners. Provide a copy of this
PRECICE ERC 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 PRECICE ERC. 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]

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 3of 54
TABLE OF CONTENTS
1. MY PRESCRIPTION............................................................................................................................................... 4
2. SYMBOLS DEFINITIONS ...................................................................................................................................... 5
3. DEFINITIONS AND GLOSSARY........................................................................................................................... 7
4. INDICATIONS FOR USE: Why is PRECICE Used?.............................................................................................. 8
5. CONTRAINDICATIONS: Who cannot use the PRECICE system?....................................................................... 9
6. WHAT YOU MUST DO TO AVOID HARM (WARNINGS) ................................................................................12
7. WHAT ARE THE RISKS........................................................................................................................................16
8. PRODUCT DESCRIPTION....................................................................................................................................17
9. ABOUT THE ERC ..................................................................................................................................................21
10. IMPLANT DETECTION FEATURES ...................................................................................................................22
11. SET UP INSTRUCTIONS. (BEFORE YOU DO TREATMENT)..........................................................................22
12. HOW TO USE THE ERC .......................................................................................................................................24
13. CHARGING THE ERC..........................................................................................................................................39
14. INSPECTING, CLEANING, STORING AND OTHERINFORMATION ............................................................42
15. MORE ABOUT YOUR CONDITION ....................................................................................................................44
16. TROUBLESHOOTING. (ERRORS).......................................................................................................................45
17. SPECIFICATIONS .................................................................................................................................................50

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 4of 54
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 or arm)
IMPLANT #1
 Right Leg
 Left Leg
 Right Arm
 Left Arm
 Tibia
 Femur
 Humerus
RIGHT SIDE
LEFT SIDE
Humerus
Femur
Tibia
Humerus
Femur
Tibia
IMPLANT #2
 Only One Implant
 Right Leg
 Left Leg
 Right Arm
 Left Arm
 Tibia
 Femur
 Humerus
Special Notes (example: always use crutches):
Need help? Call:
My Provider:
Phone:
My Doctor:
Phone:

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 5of 54
2. SYMBOLS DEFINITIONS
For Symbols Glossary, please refer to https://www.nuvasive.com/eifu/symbols-glossary
For Symbols specific to the ERC 4P reference the table below.
Symbol
Definition
IPX0
The device offers no special protection from fluid
ingress.
Go Back key(s): These are touch screen keys that
provide a method to go back to a previous screen or
software state when they are 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.
Clinical Key (During Patient Mode): 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: A digital button on the
touch screen display is used by users to begin therapy.
Control Button, Solid Red: A digital button on the touch
screen display is used by users to pause or stop therapy
at any time.
Alignment Line: This line symbol labeled on the ERC
4P identifies the center of the ERC 4P magnet length. It
can be used as method to align the ERC magnet to the
implant magnet based on the lines or sutures located on
the patient’s limb.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 6of 54
ERC 4P Position Orientation with ARROWS: This
symbol and labeling indicates the orientation of the ERC
4P 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. RIGHT indicates the right
side of the unit is positioned to the right side of the
patient.
ERC 4P Position Orientation with ARROWS: This
symbol and labeling indicates the orientation of the ERC
4P relative to the patient.
Uncoupled Implant Detection: This symbol displayed
indicates that the ERC 4P does not detect the implant
magnet or its rotation.
Coupled Implant Detection: This symbol displayed
indicates the ERC 4P has detected the implant magnet
and it is properly rotating.
Anatomic Instruction Screen
The patient’s specific left or right side femur, tibia, or
humerus will be highlighted on the screen to identify the
exact limb with the PRECICE implant. There are six (6)
possible locations for the implant, only one will be
shown with a solid purple color.
System Error Screen
This screen will appear on the control panel when there
has been an error with the operation of the ERC 4P.
In this figure “CODE: 104” is given as an example. The
screen may have a different code and information
shown.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 7of 54
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
or retract 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 or arm from outside of your body. The ERC system consists of the
ERC and Charging 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.
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) or arm bone (humerus). 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.
Tibia: The tibia (or shinbone) is the large leg bone between the knee and ankle.
Troubleshooting: The process of solving problems or determining why something does not
operate correctly.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 8of 54
4. INDICATIONS FOR USE: Why is PRECICE Used?
The NuVasive Specialized Orthopedics, Inc. (NSO) External Remote Controller, model
ERC 4P, is a portable hand-held system used to non- invasively distract or retract the Precice
Systems.
The Indications for Use of the ERC 4P when used with the Precice System (inclusive of Precice
IMLL, 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 4P 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 4P 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 implant into your limb, you will use the ERC to make
the device longer or shorter. The lengthening/shortening phase usually starts 5 days after your
surgery. You will make the PRECICE implant a small amount longer or shorter 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 implant. Usually once a week
you will visit your doctor to check on your progress. Your doctor may x- ray your leg or arm
during these visits. For femur or tibia implants, your doctor will also tell you to use crutches and
avoid putting weight on your leg with the PRECICE implant. For humerus implants, your doctor
will tell you to avoid using and putting weight on your arm with the PRECICE implant. 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/arm 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 or shortened. 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.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 9of 54
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 Systems. If you have any of these
contraindications, you cannot use a PRECICE device.
CONTRAINDICATIONS:
Your doctor will check the following to see if you would be a good fit for PRECICE (inclusive of Precice
IMLL Precice Unyte, Precice Stryde and Precice Bone Transport):
xPatients with an irregular bone diameter that would prevent insertion of the Precice nail
xPatients in which the Precice nail would cross joint spaces or open epiphyseal growth plates
xPatients 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
xPatients unwilling or incapable of following postoperative care instructions
xInfection or Pathological conditions of bone such as osteopenia which would impair the ability to
securely fix the device.
xPatients with Gusilo open fracture Classification Grade IIIB or IIIC fractures
xPatients with pre-existing nerve palsies
xMetal allergies and sensitivities
Precice Bone Transport has the following additional contraindications:
xPatients with maximum bone defect of more than 100 mm.
xPatients with excessive skin damage and not enough soft tissue covering where the fracture
sites.

Patient Manual ERC 4P
Model: ERC 4P
LC0265-D 04/2022 Page 10 of 54
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.
For Precice & Precice Unyte Nail
Limb PRECICE
Model Nail Diameter
Maximum Distance of
Treated Limb to Surface
of IM Canal
Maximum
Patient Weight
Tibia
C
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm 13 mm 57 Kg
10.7 mm, 11.5 mm, 12.5 mm
16 mm
114 kg
J
8.5 mm
13 mm
57 Kg
10.7 mm, 12.5 mm
16 mm
114 kg
Q
8.5 mm
13 mm
57 Kg
10.7 mm
16 mm
57 Kg
Femur
A-G (except
C), V, X
8.5 mm, 9.0 mm, 9.5 mm,
10.0 mm, 10.5 mm
45 mm 57 kg
10.7 mm, 11.5 mm
75 mm
114 kg
12.5 mm
90 mm
114 kg
H, K, U
8.5 mm
45 mm
57 kg
10.7 mm
75 mm
114 kg
12.5 mm
90 mm
114 kg
N, M, P
8.5 mm
45 mm
57 kg
10.7 mm
75 mm
57 kg
Humerus L, M 8.5mm
165 - 210 mm
pre-distracted
length
25 mm Non-weight
bearing
225 - 300 mm
pre-distracted length
45 mm
Non-weight
bearing
For Precice Stryde Nail
Limb
PRECICE
STRYDE
Model(s)
Nail
Diameter
Maximum Distance of
Treated Limb Surface to
IM Canal
Maximum
Patient
Weight
Tibia C, SJ
10.0
13mm
150 lbs / 69 kg
11.5
16mm
200 lbs / 91 kg
13.0
16mm
250 lbs / 114 kg
Femur A, B, C,
E, V, X
10.0
70mm
150 lbs / 69 kg
11.5
85mm
200 lbs / 91 kg
13.0
100mm
250 lbs / 114 kg
For Precice Bone Transport Nail
Limb
PRECICE Bone
Transport
Model
Nail Diameter
(mm)
Maximum Distance of
Treated Limb Surface
to IM Canal
Max. Patient Weight
Bearing
Use with partially
threaded screws
Max. Patient Weight
Bearing
Use with fully threaded
screws
Tibia
C, SJ
10.0
19mm
25lbs/11kg
25lbs/11kg
11.5
19mm
190lbs/86kg
125lbs/57kg
13.0
19mm
250lbs/114kg
125lbs/57kg
Femur
A, B, BT, D, DT,
E, V, X, SE, SB,
SD, SA
10.0
64mm
25lbs/11kgs
25lbs/11kg
11.5
69mm
190lbs/86kg
125lbs/57kg
13.0 85mm 250lbs/114kg 125lbs/57kg