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Patient Manual ERC 4P

Model: ERC 4P

LC0265-D 04/2022 Page

CAUTION: F

EDERAL 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.

ENERAL

ONTACT

NFO

101 E

NTERPRISE

, S

UITE

100 | A

LISO

IEJO

, CA 92656 P

HONE

: (+1) 855-435-5477 | F

: (+1) 949-837-3664

Содержание ERC 4P

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

Страница 2: ...lthcare 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 ...

Страница 3: ...NS 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 DOTREATMENT 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...

Страница 4: ...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 ...

Страница 5: ...ey 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 requir...

Страница 6: ...e 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 iden...

Страница 7: ...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 ...

Страница 8: ...r 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...

Страница 9: ...ts in which the Precice nail would cross joint spaces or open epiphyseal growth plates x 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 x Patients unwilling or incapable of following postoperative care instructions x Infection or Pathological...

Страница 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 ...

Страница 11: ...ck the following to see if you would be a good fit for Precice Ankle Salvage System x Infection or bone disease that would prevent successful use and operation of the device x Patients with poor quantity or quality of bone that prevents stabilization or fusion of the joints x Patients with an insufficient plantar pad x Patients having an intact asymptomatic subtalar joint x Patients with Gustilo o...

Страница 12: ...his device has not been tested for compatibility in Magnetic Resonance Imaging MRI environments and should not enter an MRI unit 6 WARNING Persons with a pacemaker or a similar medical aid should not handle or be exposed to the External Remote Controller The strong magnetic fields may affect the operation of such devices 7 CAUTION The Rare Earth Magnetics Association is not aware of any positive o...

Страница 13: ...ement charging cord 14 WARNING Do NOT use this equipment in the presence of flammable anesthetics 15 WARNING The ERC should only be placed immediately over the area of the patient s body at the magnetic portion of the implant Do not place the ERC near any other parts of the body for example portions of the body which may contain ferromagnetic material containing implants When the ERC is not being ...

Страница 14: ...on Placing the ERC in the wrong location on your leg or arm could result in the bone not lengthening or shortening correctly Your bone could harden too early if it is not lengthening or shortening correctly You may need another surgery to make your bone the right length 22 WARNING Align the ERC toward the patient s feet as in the picture below The Display screen should be facing you so it can be r...

Страница 15: ...ctor recommends the implant could be damaged or break This could result in the need for another surgery 27 PRECAUTION Do not store the ERC near any areas that may have extreme temperatures Some areas may include a heater or fireplace Extreme temperatures would be anything above 140ºF 60ºC or below 14ºF 10ºC The ERC has not been tested in those temperatures and may not work correctly Refer to the T...

Страница 16: ...d get pneumonia from the surgery x You could die from the surgery The additional potential risks of the limb lengthening shortening procedure include x You may feel pain from lengthening or shortening your bone x There may be a delayed union or non union of the bone the bone does not heal x The screws may pull out or break x There may be an infection x The implant may malfunction or break x The bo...

Страница 17: ...vated x Screws that attach the device to your bone x An External Remote Controller ERC The implant has a part called an actuator that can change length The actuator has a small magnet that allows the implant to get longer or shorter when the magnet is turned by the ERC The ERC is a hand held device with a large magnet The magnet in the actuator turns when the ERC is placed on your leg or arm and t...

Страница 18: ...you will stop lengthening or shortening your leg arm each day Now you will let your leg arm bone heal and get stronger This is the consolidation phase Your doctor will see you about once a month during this phase to check on your progress Your doctor will tell you how much weight you can put on your leg or arm It is important to follow all of your doctor s instructions 4 Removal The PRECICE implan...

Страница 19: ...54 Figure 2 ERC for the PRECICE System c Getting to know your ERC Inside your ERC Case you will find the ERC and Patient s Manual The critical parts of the ERC are labeled below Charging Cord Tibia Handle Display Screen touch screen Carrying Handle Alignment Lines ...

Страница 20: ...Patient Manual ERC 4P Model ERC 4P LC0265 D 04 2022 Page 20 of 54 Figure 3 ERC Case ...

Страница 21: ...the implanted PRECICE implant in your limb b What are the ERC Buttons and Displays ERC Buttons and Displays 3 1 Back of ERC 4P 2 1 The display screen is used to show information about the PRECICE system It can be controlled by touching various areas on the screen 2 The alignment line is used to align the ERC over the PRECICE implant using the marked location on the limb 3 The power button is used ...

Страница 22: ...condition Uncoupled Detection The ERC 4P can detect if the implant magnet is not rotating or is not present and provide feedback to the user of this condition During the therapy session the implant length displayed will not change based on this condition 11 SET UP INSTRUCTIONS BEFORE YOU DO TREATMENT 1 Choose the location where you will be doing the treatment x If using the charging cord check tha...

Страница 23: ...REA x Do not use the ERC within two 2 feet of metal objects Metal objects could be pulled very quickly to the magnet in the ERC and may injure you x Remove unattached metal items from the area jewelry knives keys etc Zippers and buttons on clothing and shoes are ok x Remove metal items from your clothing and body ...

Страница 24: ...n allows the physician access to screens for programming the ERC This icon also allows the user to start the lengthening session This icon will stop the lengthening session This icon allows the user to navigate back to the last screen This icon allows the user to navigate forward to the next screen This icon indicates that the user should reference the instruction manual for further information ...

Страница 25: ... allow the system to charge for 15 minutes Solid Green A solid green light indicates that the ERC 4P is in a safe state Blinking Green A blinking green light indicates that the ERC 4P is ready to be used for treatment Solid Red A solid red light indicates that the motor in the ERC 4P is running and the internal magnet is rotating Blinking Red A blinking red light indicates an error with the ERC 4P...

Страница 26: ...e MORE than One Implant If you have more than one implant make sure there is at least 1 FOOT of space between both implant locations before starting therapy FOR MULTIPLE IMPLANT USES BEFORE operating the ERC ensure that a minimum of 1 foot is between each implant magnet location ...

Страница 27: ...0265 D 04 2022 Page 27 of 54 Step 1 Power on the ERC POWERING ON 1 1 Press power button at back of ERC POWERING ON WITH THE CHARGING CORD 2 Plug charging cord into a wall outlet 2 3 Plug charging cord connector into ERC 3 3 Back of ERC 4P ...

Страница 28: ...al ERC 4P Model ERC 4P LC0265 D 04 2022 Page 28 of 54 WELCOME SCREEN When powered on the display will light up and the welcome screen will display for a few seconds You do not need to press anything on this screen ...

Страница 29: ...s prescribed for the entire treatment i e 50 mm The number above i e 43 50 is the total amount you have lengthened or shortened so far After reviewing this information and ensuring it is correct press the GREEN ARROW button on the screen to GO to the next screen If this information is not correct contact your doctor immediately 3 PATIENT SUMMARY SCREEN The ERC allows four 4 prescriptions to be 3 e...

Страница 30: ... Femur D Right Femur E Left Humerus F Right Humerus Your implant location will be displayed The 1 limb to be lengthened will be highlighted in purple In this example screen the RIGHT FEMUR is highlighted Press the flashing GREEN GO button on the ERC once you have aligned the ERC After reviewing this information press the GREEN ARROW button to GO to the next screen If the displayed information is n...

Страница 31: ...ress flashing GREEN GO button to start session 4 Session is now started Example image of right femur session Note if you feel discomfort resting the ERC on your femur it is appropriate to use a soft thin pad as a barrier i e cloth Example image of right tibia session Note if you feel discomfort resting the ERC on your tibia it is appropriate to use a soft thin pad as a barrier i e cloth Or rest th...

Страница 32: ...e ERC can also be used for the tibia as shown Right Humerus Example ERC ALIGNMENT Humerus 1 A second person or caregiver should administer treatment 2 Point ERC towards patient s feet as indicated on display and move to patient s arm 3 Use alignment lines to center ERC over implant and mark on patient s arm 4 Press flashing GREEN GO button to start session 5 Session is now started Example of a rig...

Страница 33: ...ibed amount and will stop running Distance counter This number will 2 increase as the implant lengthens or shortens It will stop at the prescribed length for that session 3 Time left the amount of time left until the session is complete Coupling icon this icon lets you know 4 that the ERC is coupled with the implant When the gauge points to the green area and the green check mark appears you are c...

Страница 34: ...e than the prescribed daily prescription Press the GREEN ARROW GO button to finish your session If you finished a session but have notfinished your daily lengthening or shortening the SESSION COMPLETE screen will appear It will appear with a summary of your session 1 Turn off your ERC by pressing the Power Button 2 Place the ERC in the storage case 3 Close and latch storage case 4 Store in a safe ...

Страница 35: ...ge case 4 If not charging close and latch storage case If charging gently place lid down 5 Store the case in a safe place away from children The GOAL COMPLETE screen will appear if you have achieved the total length prescribed by your physician i e 50 00mm 1 Turn off your ERC by pressing the Power Button 2 If the charging cord is used leave the ERC powered on and the chargingcord plugged in until ...

Страница 36: ...ng the ERC during your session You may pause the ERC at any time during the session It is not harmful to do this because the ERC remembers your progress If you do require a pause in treatment follow the instructions below 1 You may press the RED STOP button at 1 any time during your session This will cause the ERC to stop immediately ...

Страница 37: ...C using the alignment lines over the mark on your leg or arm Once you have positioned the ERC correctly press the GREEN GO button to start the session Step 6 Screens you may see during your session You may see any one of the following screens while using ERC REPOSITION ERC This screen will display if the ERC loses coupling or connection with the magnet in the implant 1 Reposition ERC using alignme...

Страница 38: ...lowing happens the SENSOR ON feature is selected and the therapy session is in progress The IMPLANT STATUS icons will be seen in the In Progress or Uncoupled UNCOUPLED This icon means that the ERC 1 has not connected with the implant magnet during the session COUPLED This icon means that the ERC has connected with the implant magnet 2 during the session ...

Страница 39: ...y and 2 Critical Battery If you need to charge the ERC follow the instructions below LOW BATTERY CONDITION A message will be displayed indicating 1 the ERC battery is LOW A low battery condition is indicated by 2 the YELLOW battery icon and two battery segments Plug the charging cord into the ERC and 3 plug into the wall plug to charge the battery Once you have plugged in the ERC press the GREEN A...

Страница 40: ...he ERC battery is CRITICAL Additionally the battery icon becomes 5 RED and one battery segment remains You must plug in the ERC to charge the battery 5 CRITICAL BATTERY CONDITION Once you have plugged in the ERC you 5 may continue the previous session by pressing the GREEN ARROW button to dismiss the error screen and continue where you left off ...

Страница 41: ... plugged in 2 Place the ERC in the case with the cord connected and plugged in 3 Gently rest the top of the case over the ERC Do not latch the case closed on the charging cord 4 Press the GREEN ARROW button 7 INCORRECT POWER SUPPLY This message will appear if the wrong 7 charging cord is plugged into the ERC Plug in the supplied charging cord into the ERC Once you have plugged the appropriate char...

Страница 42: ...edics Inc c Travel and International Use x It is not recommended to travel during your treatment If travel is necessary check with your doctor first If you travel outside of the country during lengthening or shortening ask your doctor about giving you an ERC that will work for where you will be going x Air Travel with your ERC The ERC is not considered Carry On luggage If you travel by airplane th...

Страница 43: ...10ºC e Storing the ERC while charging ERC AND POWER CORD SHOULD BE STORED IN THE CASE AND AWAY FROM CHILDREN WHEN NOT IN USE 1 When charging in between sessions place ERC in storage case and keep the ERC powered on 2 Make sure that all parts are inside and away from case edges 3 DO NOT latch and lock case while the charging cord is connected into a wall outlet and connected to the ERC Latching and...

Страница 44: ...o check on your progress Consolidation During this phase you will still need to keep your weight off of your implanted limb Your doctor will advise you on your weight bearing ability You may still need crutches or a wheelchair and have limited mobility for lower limb implants You will also need to have regular usually monthly visits to your doctor to check on your progress Removal After your bone ...

Страница 45: ...wer 1 Make sure that the ERC battery is charged by plugging the charging cord into the ERC and a working outlet 2 If the charging cord is already plugged in try plugging the adapter into a different outlet The ERC is damaged Contact NuVasive Specialized Orthopedics Inc The ERC is cracked or damaged ERC was accidently dropped Do not use the ERC Call your doctor for a replacement Your prescription i...

Страница 46: ...nt ERC POSSIBLE ERROR CODE DESCRIPTION WHAT TO DO Code 020 Power Button Stuck If the Power Button is stuck then this error will occur Ensure the Power Button is not being held down while the ERC is powered on If this error still persists then the ERC must be replaced Contact NuVasive Specialized Orthopedics Inc Code 021 ERC Malfunction Disconnect the power supply and hold down the power button for...

Страница 47: ... the power button and restart the system If this error persists then the ERC must be replaced Contact NuVasive Specialized Orthopedics Inc Code 100 System Error This error will occur if there is a system communication malfunction with the ERC Power down the ERC by pressing or holding the power button and restart the system If this error persists then the ERC must be replaced Contact NuVasive Speci...

Страница 48: ...opedics Inc Code 130 Temperature Too Hot This error will occur if the temperature of the ERC 4P is too hot The ERC must be placed in a cooler environment and allowed to cool down If this error persists the ERC must be replaced Contact NuVasive Specialized Orthopedics Inc Code 131 Temperature Too Cold This error will occur if the temperature of the ERC 4P is too cold The ERC must be placed in a war...

Страница 49: ...ontact NuVasive Specialized Orthopedics Inc Code 146 Battery Error This will occur if the battery is malfunctioning The ERC must be replaced Contact NuVasive Specialized Orthopedics Inc Code 147 Battery Error This will occur if the battery charging is malfunctioning Plug in the power supply to use of the ERC Code 200 Code 201 System Error Power down the ERC by pressing or holding the power button ...

Страница 50: ... Power Current Maximum 1 A Weight ERC 4P 3 4 7 5 kg lbs ERC 4P with Carrying Case 10 4 22 9 kg lbs Description Rating Classification for Shock Protection Class II No reliance on protective earth double insulated Applied Part Type Shock Leakage Current Type BF Basic Floating Defibrillation Rating Not Defibrillator Proof Anesthetic Use Do NOT use this equipment in the presence of flammable anestheti...

Страница 51: ... used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 2 4 8 kV contact 2 4 8 15 kV air 2 4 8 kV indirect HCP and VCP Complies Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst...

Страница 52: ...m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is af...

Страница 53: ... at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These gui...

Страница 54: ...terfront Elstree Herts United Kingdom only 101 Enterprise Suite 100 Aliso Viejo CA 92656 Phone 1 855 435 5477 Fax 1 949 837 3664 2017 NuVasive Inc All rights reserved is a registered trademark of NuVasive Inc PRECICE is a registered trademark of NuVasive Specialized Orthopedics Inc NuVasive Specialized Orthopedics Inc is a trademark of NuVasive Inc ...

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