External Remote Controller 2 Operators Manual Rev M

Operator’s Manual ERC 2

Model: ERC 2

Table of Contents

1.

SYMBOLS DEFINITION:...3

2.

PRODUCT WARNINGS: ...6

3.

PRODUCT DESCRIPTION: ...8

4.

COMPONENT IDENTIFICATION:...8

5.

INSTRUCTIONS FOR USE:...9

6.

EMERGENCY PROCEDURES: ...11

7.

CONTROLS LAYOUT:...12

8.

SCREEN NAVIGATION: ...12

9.

FAULT NOTIFICATION MESSAGES: ...18

10. MAINTENANCE & CLEANING:...19 11. DISPOSAL: ...19 12. SPECIFICATIONS:...20

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Operator’s Manual ERC 2

Model: ERC 2

1. Symbols Definition: The following symbols are used to highlight hazards and to indicate proper usage of the External Remote Controller 2 (ERC 2) Symbol 1.1.

Definition WARNING – GENERAL This symbol indicates hazards or unsafe practices which could result in personal injury, product, or property damage.

1.2.

WARNING – MAGNETIC FIELDS This symbol indicates specific hazards related to the strong magnetic fields always present in the External Remote Controller.

1.3.

PROHIBITED – NO ACCESS FOR PEOPLE WITH ACTIVE IMPLANTED CARDIAC DEVICES Persons with a pacemaker or a similar medical aide should not handle or be exposed to the External Remote Controller. The strong magnetic fields can affect the operation of such devices.

1.4. PROHIBITED - UNSAFE IN MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENTS 1.5.

ERC 2 ORIENTATION ALIGNMENT ARROW Align the ERC 2 with this arrow pointing towards the patient’s head.

1.6.

ERC 2 TO IMPLANT MAGNET ALIGNMENT WINDOW

Position the ERC 2 parallel to the implant magnet location. Implant magnet location should be aligned within the Alignment Window 1.7.

EXTEND IMPLANT This is the Extend mechanical push button on the ERC 2

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Operator’s Manual ERC 2 1.8.

Model: ERC 2

RETRACT IMPLANT This is the Retract mechanical push button on the ERC 2

1.9. TYPE BF APPLIED PART (Basic Floating)

1.10. REF

MODEL NUMBER

SN

SERIAL NUMBER

1.11.

1.12. MANUFACTURE DATE 1.13. MANUFACTURED BY 1.14. REFER TO INSTRUCTION MANUAL/BOOKLET Instruction manual/booklet must be read prior to use 1.15. CLASS II EQUIPMENT

1.16. Do not discard this equipment in the trash. Please return it to the manufacturer or an approved electronic waste recycling center.

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Operator’s Manual ERC 2

Model: ERC 2

1.17.

Rx Only

Federal (US) law restricts the sale of this device for use by or on the order of a physician.

1.18. Authorized European Representative EC REP 1.19.

European Conformity (Conformité Européene) This product has met European Union health, safety, and environmental requirements, which ensure consumer and workplace safety.

1.20.

Power Supply Label Only: European Conformity (Conformité Européene) This product has met European Union health, safety, and environmental requirements, which ensure consumer and workplace safety. CE marked to LVD (Low Voltage Directive).

1.21. Power Supply Label Only: Direct Current 1.22.

~

Power Supply Label Only: Alternating Current

1.23. Power Supply Label Only: RoHS (Reduction of Hazardous Substances) Compliant

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Operator’s Manual ERC 2

Model: ERC 2

2. Product Warnings: Please observe all safety precautions. 2.1. * WARNING * Always confirm the predicted implant adjustment length displayed by the ERC2 with X-ray measurements. 2.2. * WARNING * Only use the ERC 2 in a manner consistent with this Operator’s Manual. Any alternative use may result in injury or damage to property. 2.3. * WARNING * This equipment is intended for use by healthcare professionals only. This equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the ERC 2 or shielding the location. Reference section 12.24 2.4. * PROHIBITED * Persons with a pacemaker or a similar medical aide should not handle or be exposed to the ERC 2. The strong magnetic fields may affect the operation of such devices. 2.5. * WARNING * The ERC 2 uses strong permanent magnets. Misuse of this system can cause serious personal injury. Make sure the work area is free of metal objects before use. This includes personal items such as jewelry, watches, keys, and cellular phones. Always return the system to its protective case when not in use. 2.6. * WARNING * Only operate the ERC 2 by holding onto both of the handles provided.

2.7. * WARNING * The ERC 2 may be pulled away from your hands if brought too close to other magnetic objects. Always maintain a firm grip on the ERC 2 and be very aware of other objects in your work area. Also, tools or other hazardous objects may leap towards the ERC 2 if brought too close.

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Operator’s Manual ERC 2

Model: ERC 2

2.8. * WARNING * If this equipment is damaged, beware that magnet shards from broken magnets are very sharp. Always handle broken magnets with thick protective gloves.

2.9. * WARNING * Never place the ERC 2 near electronic media or appliances. The strong magnetic field may damage magnetic media such as floppy disks, credit cards, magnetic I.D. cards, cassette tapes, video tapes or other such devices. It can also damage televisions, VCRs, computer monitors and other CRT displays. 2.10. * WARNING * There are no user serviceable components inside this device. Do not open the unit. Severe personal injury or damage to the equipment may result. Service should only be performed by qualified personnel. 2.11. * WARNING * Only use the supplied power cord or an equivalent hospital grade cord rated for 10 Amps minimum. Replacement power cords are available from Customer Service at 1-855-435-5477. 2.12. * WARNING * Do NOT use this equipment in the presence of flammable anesthetics or oxygen rich environment. 2.13. * WARNING * The ERC 2 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 2 near any other parts of the body, for example, portions of the body which may contain ferromagnetic material containing implants. When the ERC 2 is not being actively used on the patient, it should always be kept within its protective case. 2.14. * WARNING * This device has not been tested for compatibility in Magnetic Resonance Imaging (MRI) environments and should not enter an MRI unit.

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Operator’s Manual ERC 2

Model: ERC 2

3. Product Description: The ERC 2 is a portable hand held system used to non-invasively extend or retract a MAGEC® Implant. 4. Component Identification: Figure 4A and 4B identifies the major components of the system.

ERC 2 Device

Power Supply

Control Panel

Power Cord

Mechanical Push Buttons Figure 4A, ERC 2 Major Components

Distal End Proximal End Figure 4B, ERC 2 Accessories – MAGEC Magnet Locator OM0006 Rev M 03/2022

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Operator’s Manual ERC 2

Model: ERC 2

5. Instructions For Use: The following section describes the setup and procedure for adjusting an implant using the ERC 2. 5.1.Have the patient remove any thick clothing like sweaters or jackets that may be covering the implant area. A thin, non-metallic, shirt is fine. 5.2.Have the patient remove any loose metal objects. (i.e. belts, buckles, jewelry, cell phones, keys, etc.) 5.3.Lay the patient face down on a non-magnetic examination table. 5.4.Cover the implant magnet area with a drape. 5.5. Hold the MAGEC Magnet Locator vertically by its distal end. Move it to a position just above the skin surface of the patient near the location of the internal magnet. Allow the locator to be pulled or attached to the strongest point of attraction. The locator will naturally align itself with the internal magnet. 5.6. Make a mark where this point of attraction occurs. 5.7.NOTE: When plugging in the ERC 2, ensure there is no contact with the green or yellow pushbuttons. Plug the ERC 2 into an accessible and appropriate power outlet close to the patient. 5.8.Select the desired adjustment mode (Target or Continuous). Reference section 8.2 & 8.3. If the touchscreen does not respond properly, contact Customer Service at 1-855-435-5477. 5.9.Enter the absolute target distraction length amount (if in “Target” mode) of the patient’s implant into the control panel. 5.10. * WARNING * The ERC 2 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 2 near any other parts of the body, for example, portions of the body which may contain ferromagnetic material containing implants. When the External Remote Controller is not being actively used on the patient, it should always be kept within its protective case. 5.11. * WARNING * If retraction of the Implant is needed, never retract the implant more than the amount lengthened the previous week. Failure to follow this warning may result in pulling biological material that may have adhered to the rod of the implant into the internal space of the actuator of the implant.

5.12. Position the implant Alignment Window of the ERC 2 over the implant magnet area. The ERC 2 should be oriented along the axis of the implant with its Orientation Arrow pointing towards the patient’s head. Reference figure 5A. OM0006 Rev M 03/2022

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Operator’s Manual ERC 2

Model: ERC 2

implant locating window

Figure 5A, ERC 2 Placement over Implant 5.13. Maintain the ERC 2 orientation per figure 5A while slowly sweeping it side to side and head to toe over the implant area. The ERC 2 magnets will pull downward towards the implant magnet when it is in the optimal position. 5.14. Hold the ERC 2 against the patient over the implant. 5.15. Press the Extend or Retract button as needed to adjust the implant as directed by the physician. 5.16. After adjustment, always confirm the amount of distraction by x-ray imaging. Reference figure 5B.

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Operator’s Manual ERC 2

Standard Rod

Implant Magnet

Implant Magnet

Model: ERC 2

Offset Rod

Distraction Length 9.0 mm Reference Diameter

Figure 5B, Implant Distraction Measurement from X-ray 6. Emergency Procedures: 6.1.Runaway External Remote Controller! In case of any emergency such as if the ERC 2 fails to stop, lift the ERC 2 off of the patient’s body. This will undo the magnetic coupling between the ERC 2 and the implant and will stop the adjustment. Place the ERC 2 in its protective case and then unplug the device from its power source. Contact Customer Service at 1-855-435-5477 to arrange to return the ERC 2.

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Operator’s Manual ERC 2

Model: ERC 2

7. Controls Layout: The ERC 2 has two handles for positioning the unit over the implant. The ERC 2 also has two momentary push buttons. The green push button is for extending and the yellow push button is for retracting the implant. Pressing and holding either of the push button causes the ERC 2 to adjust the implant in the desired direction. Releasing the button causes the ERC 2 to stop. Pressing both buttons simultaneously also causes the ERC to stop. Reference figure7A.

3

1

2

5

4

Figure 7A, ERC 2 Controls Layout

1 2 3 4 5

Loop Grip handle. Round Grip handle. Green Extend mechanical push button. Yellow Retract mechanical push button. LCD Touch Screen Control Panel

8. Screen Navigation: The ERC 2 LCD touch screen has several screens used for various functions. The function and use of each screen is described in detail in this section. If the touchscreen does not respond properly, contact Customer Service at 1-855-435-5477. 8.1. Power Up Screen: This screen is the “power up” screen. This screen displays for a few seconds when the ERC 2 is powering up.

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Operator’s Manual ERC 2

Model: ERC 2

Figure 8A, Powering Up Screen

8.2. Main Operating Screen (Target Mode): After power up, the ERC 2 LCD touch screen control panel will default to the Main Operating Screen in “Target” Mode (figure 8B). Target mode allows the user to input a fixed set point distance to move the implant. If a positive TARGET value is set, the ERC 2 will automatically stop when the implant has extended to the set TARGET value. A negative TARGET value cannot be set for the ERC 2. The ERC 2 may not be set up to limit the amount a user may retract an implant. The user must actively monitor the amount of retraction. The TARGET set value can be modified in two ways. Pressing the “+” button will increment the TARGET distraction value. Pressing the “-“button will decrement the TARGET value. Note that the “-“push button will not appear until the target set value is > 0.0mm. Alternatively, pressing the “#” button will bring up a numeric keypad screen (figure 8C). The keypad screen enables the user to directly input the TARGET distraction value. To change or correct the TARGET value first press the button labeled “ZERO”. Pressing “ZERO” will zero out the TARGET value and enable the user to enter a new TARGET value. After the desired value has been entered press the “ACCEPT” button. Pressing the “ACCEPT” button will confirm the desired TARGET set value for the ERC 2 and return the control panel to the Target mode main operating screen. OM0006 Rev M 03/2022 P a g e | 13

Operator’s Manual ERC 2

Model: ERC 2

After the TARGET set value has been established and the ERC 2 is properly placed over the implant (reference section 5) press the green mechanical push button on the ERC 2 when ready to extend the implant. The ERC 2 will extend the implant until the TARGET set point is reached and then it will stop automatically. Note that releasing the green extend button always stops the adjustment at any moment. Pressing the green Extend button again will continue extending the implant from where it was last left off. During the distraction process both the actual distraction amount and the distraction progress as a percentage of the TARGET amount is actively displayed in the “ACTUAL” value line and progress bar respectively. The ERC 2 will automatically stop once the “ACTUAL” value equals the TARGET set value. Pressing the green mechanical Extend button will not activate the ERC 2 when the ACTUAL value equals the TARGET value. Pressing the “ZERO” button adjacent to the ACTUAL value will reset the ACTUAL value back to 0.0 and enable the ERC 2 to be activated until the TARGET value is reach again. At any moment pressing the yellow mechanical Retract push button will cause the ERC 2 to switch to retracting the implant. There is no set value or limit to the amount of retraction by the ERC 2. Holding down the yellow mechanical Retract push button will cause the ERC 2 to retract indefinitely. The ACTUAL value and progress bar will actively decrement accordingly from the place it was at when the yellow mechanical Retract push button was pressed.

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Operator’s Manual ERC 2

Model: ERC 2

Target Mode Operating Screen Prior to Input of Target Length or Activating ERC 2

Target Mode Operating Screen after Activating ERC 2 towards Set Target length

Actual Progress Value

Progress Bar

Figure 8B, Target Mode Operating Screen

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Operator’s Manual ERC 2

Model: ERC 2

Figure 8C, Numeric Keypad for Input of Target Set Value

8.3. Main Operating Screen (Continuous Mode): Continuous mode allows the ERC 2 to run as long as the Extend or Retract Hand Piece push buttons are held. The value displayed next to Cont. Mode increases or decreases as the implant is adjusted. Pressing the button labeled “MODE” on the Target mode operating screen toggles the main operating screen from Target mode to Continuous mode (figure 8D). Continuous mode allows the ERC 2 to run as long as the green Extend or yellow Retract push buttons are held down. There is no set point value to tell the ERC 2 to stop.

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Operator’s Manual ERC 2

Model: ERC 2

Figure 8D, Continuous Mode Main Operating Screen The ACTUAL value displayed on the Continuous mode operating screen increases or decreases as the implant is adjusted. The progress bar will not display the actual progress in Continuous mode. The progress bar will turn green when the green Extend mechanical push button is pressed and yellow when the yellow Retract mechanical push button is pressed. Pushing the “ZERO” key will zero out the ACTUAL value to 0.0mm. Pressing “MODE” in Continuous mode will toggle the operating screen back to the Target mode operating screen. 8.4. System Information Screen: Pressing the “INFO” button on either the Target or Continuous mode main operating screens will bring up the ERC 2 System Information Screen (figure 8E). The information screen provides some useful information about the ERC 2 that maybe helpful when the user contacts Customer Service for technical support. Contact Customer Service at 1-855-435-5477. A system odometer keeps track of the sum of all work output (whether extending or retracting) exerted by the ERC 2. The current software version and revision information is also provided on this screen. The top right button labeled “SYSTEM” is designated for use by service personnel only and not relevant for the user. If the “SYSTEM” button is accidently pressed a password screen will appear asking for a system password. If no password is entered within a few seconds the screen will revert back to the System Information Screen. Pressing the “MAIN” button at any time will revert back to either of the Main Operating Screens.

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Operator’s Manual ERC 2

Model: ERC 2

Figure 8E, ERC 2 System Information Screen

9. Fault Notification Messages: A Fault Message Screen may display if the unit malfunctions (figure 9A). A numeric value will appear in the window line item labeled “Error Code.” Make note of the numeric error code when contacting Customer Service at 1-855-435-5477 for technical assistance. Do not attempt to use a malfunctioning ERC 2.

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Operator’s Manual ERC 2

Model: ERC 2

Figure 9A, Fault Notification Message Screen 10. Maintenance & Cleaning: 10.1. * WARNING * There are no user serviceable components inside this device. Do not open the unit. Severe personal injury or damage to the equipment may result. Service should only be performed by qualified personnel. 10.2. * WARNING * Only use the supplied power cord or an equivalent cord rated for 10 Amps minimum. Replacement power cords are available from Customer Service at 1855-435-5477. 10.3. To clean the external surfaces of the ERC 2, unplug power cord and wipe with a water moistened cloth. Do not submerge any component of the ERC 2 in liquid. Severe personal injury or permanent damage to the ERC 2 may result. 11. Disposal: Do not dispose of the External Remote Controller in the trash. Please return it in its protective case or receive disposal directions by calling customer service at 1-855435-5477. Do not incinerate this equipment. The ERC 2 contains rare earth magnets which burn extremely hot if ignited.

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Operator’s Manual ERC 2

Model: ERC 2

12. Specifications: Description Display Accuracy1 Operating Temperature Operating Relative Humidity Storage Temperature Storage Relative Humidity Input Power Voltage (Single Phase) Input Power Frequency Input Power Current (Maximum) Weight: External Remote Controller 2 Device with Carrying Case 12.10. Maximum Continuous On Time 12.11. On Time / Off Time 12.1. 12.2. 12.3. 12.4. 12.5. 12.6. 12.7. 12.8. 12.9.

Description 12.12. Classification for Shock Protection. 12.13. Applied Part Type Shock & Leakage Current. 12.14. Defibrillation Rating. 12.15. Anesthetic Use. 12.16. Ingress Protection. 12.17. Method of Sterilization. 12.18. High Altitude Use. 12.19. Pollution Degree. 12.20. Over Voltage Category.

Rating ±10% + ±0.3 10 – 40 (50 – 104) 30 - 75 -10 – 60 (14 – 140) 5 – 95 (Non Condensing) 100 – 240 50 / 60 2.3 3.7 (8.1) 11.0 (24.3) 30 10 / 90

Units mm oC (oF) % oC (oF) % VAC Hz A kg (lbf) Minutes %

Rating Class II No reliance on protective earth, double insulated. Type BF (Basic Floating). Not Defibrillator Proof. Do NOT use this equipment in the presents of flammable anesthetics. (Neither AP nor APG) IPXO Non-Sterile. Not rated for use over 3000 m (9842 ft) altitude. Pollution Degree 2 (Office Environment). Category II.

Note 1: * WARNING * Always confirm the predicted implant adjustment length displayed by the External Remote Controller with X-ray measurements.

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