Operator’s Manual ERC 3P
Model: ERC 3P
LC0216-H-2/2022
Page
1
of
45
External Remote Controller ERC 3P
Patient Manual
CAUTION:
F
EDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
.
Страница 1: ...Operator s Manual ERC 3P Model ERC 3P LC0216 H 2 2022 Page 1 of 45 External Remote Controller ERC 3P Patient Manual CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN...
Страница 2: ...py 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 th...
Страница 3: ...o 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 an...
Страница 4: ...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 I...
Страница 5: ...d 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...
Страница 6: ...icates 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...
Страница 7: ...ing 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 indic...
Страница 8: ...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 i...
Страница 9: ...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 lengt...
Страница 10: ...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 medulla...
Страница 11: ...merus L M 8 5mm 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...
Страница 12: ...he Precice Ankle Salvage System Active infection or pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the device Patients with an insufficient quantity or...
Страница 13: ...his device Only use the External Remote Controller in a manner consistent with this Operator s Manual Any alternative use may result in injury or damage to property WARNING This equipment may cause ra...
Страница 14: ...and tools before use This includes personal items such as jewelry watches keys and cellular phones Do not use the ERC with metal magnetic objects within the designated vicinity WARNING If this equipme...
Страница 15: ...hes 30 centimeters from the skin This will undo the magnetic coupling between the ERC and the implant and will stop the adjustment Place the ERC in its protective case and power off the unit Unplug th...
Страница 16: ...the bone that will not heal WARNING Always put the ERC on the skin directly over the implant and in the correct direction Placing the ERC in the wrong location on your limb could result in the bone n...
Страница 17: ...y WARNING Follow the instructions your doctor gives to you about how much weight to put on your leg during your treatment If you put more weight on your leg than your doctor recommends the device coul...
Страница 18: ...ould have a heart attack Myocardial infarction from the surgery You could get pneumonia from the surgery You could die from the surgery The additional potential risks of the limb lengthening procedure...
Страница 19: ...length when activated Screws that attach the device to your bone An External Remote Controller ERC The adjustable implant device has a part called an actuator that can change length The actuator has a...
Страница 20: ...doctor about once a week to check on your progress Your doctor may x ray your leg when you visit 3 Consolidation After your leg is the right length you will stop lengthening your leg each day Now you...
Страница 21: ...ck if your lengthening is on track Post Removal You will stay in the hospital after surgery to remove the Precice device from your leg You will get to go home once you heal Getting to know your ERC In...
Страница 22: ...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 t...
Страница 23: ...uttons and Displays ERC Buttons and Displays The display screen is used to show information about the Precice system It can be controlled by touching various buttons on the screen The controller butto...
Страница 24: ...electronic devices within one foot of the ERC These electronic devices could get damaged 2 Remove all loose metal from your treatment area Remove metal items from your clothing and body Remove unatta...
Страница 25: ...s the user to start the lengthening session This icon will stop the lengthening session This icon will pause the lengthening session This icon allows the user to navigate back to the last screen This...
Страница 26: ...ON SET UP SCREEN 1 Keep ERC in storage case 2 Ensure all metal items are removed from you and within 1 foot of you This includes jewelry knives keys credit cards cell phones tablets computers metal ho...
Страница 27: ...patient summary screen will be shown Goal is the total amount your physician has prescribed for lengthening i e 60 mm The number in purple i e 43 50 mm is the total amount you have lengthened so far...
Страница 28: ...tifies current session to be completed After reviewing this information press the GREEN button on the ERC to GO to the next screen If this information is not correct contact your doctor Step 4 Alignin...
Страница 29: ...indow and target symbol to center ERC over implant and mark on your leg 4 Also align with white lines on side of purple handles and base of ERC 5 Press green GO button to start session 6 Session is no...
Страница 30: ...the ERC on your tibia it is appropriate to use a soft thin pad as a barrier i e cloth Or rest the ERC more to the outside of the leg The ERC can also be used for the tibia as shown below Right Tibia...
Страница 31: ...ill stop running Distance counter This number will increase as the device lengthens It will stop at the prescribed length for that session Time left the amount of time left until the session is comple...
Страница 32: ...ERC Place the ERC and power cord in the storage case and store in a safe place not accessible by children The Goal Complete screen will appear It appears if you have achieved the total length prescrib...
Страница 33: ...ss the red STOP button at any time during your session This will cause the ERC to stop immediately If the red stop button has been pushed the pause screen will appear When ready to resume your session...
Страница 34: ...on ERC using locating window and alignment lines on ERC See Section ERC Alignment Press green Go button when you are ready to resume your session REPOSITION ERC This screen will display if the implant...
Страница 35: ...LED This icon means that the ERC has not sensed a magnet spinning during the session Reposition and realign then press Go until icon indicates ERC is connected to the implant COUPLED This icon means t...
Страница 36: ...ening ask your doctor about giving you an ERC that will work for where you will be going Air Travel with your ERC The ERC is not considered Carry On luggage If you travel by airplane the ERC must be p...
Страница 37: ...ise you to keep your weight off of your leg You may require crutches or a wheelchair to get around You will have regular usually once a week visits with your doctor to check on your progress Consolida...
Страница 38: ...blem Possible Reason Possible Solution You missed a treatment You forgot your treatment session Contact your doctor for help The ERC does not have power 1 Make sure that the ERC Power Cord is plugged...
Страница 39: ...RROR CODE DESCRIPTION WHAT TO DO Code 020 Button Stuck Error If the External Control Button is stuck then this error will occur Ensure the Control Button is not being pressed when the ERC is power on...
Страница 40: ...motor to cool down may eliminate this error from occurring If this error still persists the ERC must be replaced Contact NuVasive Specialized Orthopedics Inc Code 122 Motor Temperature Error This erro...
Страница 41: ...mum 2 3 A Weight ERC 3P 4 9 kg lbs ERC 3P with Carrying Case 11 24 kg lbs Maximum Continuous On Time 10 Minutes On Time Off Time 10 90 Description Rating Classification for Shock Protection Class II N...
Страница 42: ...unity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 2 4 6 kV contact 2 6 8 kV air 2 4 6 kV indirect HCP and VCP Complies Flo...
Страница 43: ...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...
Страница 44: ...transmitters rated 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 wher...
Страница 45: ...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 NuVa...
