Operator s Manual External Remote Controller (ERC)

Transcription

1 OM0000-C, Page 1 of 25

2 Table of Contents 1. SYMBOLS DEFINITION: PRODUCT WARNINGS: PRODUCT DESCRIPTION: COMPONENT IDENTIFICATION: INSTRUCTIONS FOR USE: EMERGENCY PROCEDURES: CONTROLS LAYOUT: SCREEN NAVIGATION: ALARM MESSAGES: MAINTENANCE & CLEANING: DISPOSAL: SPECIFICATIONS:...21 OM0000-C, Page 2 of 25

3 1. Symbols Definition: The following symbols are used to highlight hazards and to indicate proper usage of the External Remote Controller. Symbol Definition 1.1. WARNING GENERAL PURPOSE This symbol indicates hazards or unsafe practices which could result in personal injury, product, or property damage WARNING - STRONG MAGNETIC FIELDS PRESENT This symbol indicates specific hazards related to the strong magnetic fields always present in the External Remote Controller WARNING MAY INTERFERE WITH PACEMAKERS 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 Magnetic Hand Piece Alignment Align the Magnetic Hand Piece with this arrow pointing towards the patients head Extend Implant This symbol is located next to the Extend button on the Magnetic Hand Piece Retract Implant This symbol is located next to the Retract button on the Magnetic Hand Piece Basic Floating OM0000-C, Page 3 of 25

4 1.8. REF Model Number 1.9. SN Serial Number Manufacture Date Manufactured By Read the before using this equipment Double Insulated Do not discard this equipment in the trash. Please return it to the manufacturer or an approved electronic waste recycling center Rx only Federal (US) law restricts the sale of this device for use by or on the order of a physician Authorized European Representative EC REP European Conformity (Conformité Européene) This product has met European Union health, safety, and environmental requirements, which ensure consumer and workplace safety 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) Power Supply Label Only: Direct Current OM0000-C, Page 4 of 25

5 1.20. Power Supply Label Only: Alternating Current Power Supply Label Only: RoHS (Reduction of Hazardous Substances) Compliant OM0000-C, Page 5 of 25

6 2. Product Warnings: Please observe all safety precautions * WARNING * Always confirm the predicted implant adjustment length displayed by the External Remote Controller with X-ray measurements * WARNING * Only use the External Remote Controller in a manner consistent with this. Any alternative use may result in injury or damage to property * 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 reorienting or relocating the model P003 External Remote Controller or shielding the location. Reference section * WARNING * Persons with a pacemaker or a similar medical aide should not handle or be exposed to the External Remote Controller. The strong magnetic fields may affect the operation of such devices * WARNING * The Ellipse Technologies External Remote Controller 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 * WARNING * Only operate the External Remote Controller by holding onto both of the handles provided * WARNING * The External Remote Controller may be pulled away from your hands if brought too close to other magnetic objects. Always maintain a firm grip on the External Remote Controller and be very aware of other objects in your work area. Also, tools or other hazardous objects may leap towards the External Remote Controller if brought too close. OM0000-C, Page 6 of 25

7 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 * WARNING * Never place the External Remote Controller 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 * 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 * WARNING * For continuous protection against fire, replace the fuse with the same type and rating. Always disconnect the device from its power source when replacing the fuse. Reference section * WARNING * Only use the supplied power cord or an equivalent hospital grade cord rated for 10 Amps minimum. Replacement power cords are available from Ellipse Technologies * WARNING * Do NOT use this equipment in the presents of flammable anesthetics * WARNING * The External Remote Controller should only be placed immediately over the area of the patient s body at the magnetic portion of the Ellipse Adjustable Implant. Do not place the External Remote Controller 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. OM0000-C, Page 7 of 25

8 3. Product Description: The Ellipse Technologies model P003 is a portable hand held system used to non-invasively extend or retract an Ellipse Technologies Adjustable Implant. 4. Component Identification: Figure 4A identifies the major components of the system. Control Panel Magnetic Hand Piece Power Cord Power Supply Figure 4A, External Remote Controller Major Components OM0000-C, Page 8 of 25

9 5. Instructions For Use: The following section describes the setup and procedure for implant adjustment using the External Remote Controller 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 Have the patient remove any metal objects from their person. (i.e. belts, buckles, jewelry, cell phones, keys, etc.) 5.3. Lay the patient face down on a non-magnetic examination table Cover the implant magnet area with a sterile drape Plug the External Remote Controller into an appropriate power outlet close to the patient Enter the absolute distraction length (Abs Length) of the patient s implant into the control panel. Reference section 8.2 display line Select the desired adjustment mode (Incremental or Continuous). Reference section * WARNING * The External Remote Controller should only be placed immediately over the area of the patient s body at the magnetic portion of the Ellipse Adjustable Implant. Do not place the External Remote Controller 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 * WARNING * If retraction of the Ellipse Adjustable 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 Position the implant locating window of the Magnetic Hand Piece over the implant magnet area. The Magnetic Hand Piece should be oriented along the axis of the implant with its arrow pointing towards the patient s head. Reference figure 5A. OM0000-C, Page 9 of 25

10 implant locating window Figure 5A, ERC Placement Over Implant Maintain the Magnetic Hand Piece orientation per figure 5A while slowly sweeping it side to side and head to toe over the implant area. The Magnetic Hand Piece will pull downward towards the implant when it is in the optimal position Hold the Magnetic Hand Piece against the patient over the implant Press the Extend or Retract button as needed to adjust the implant as directed by the physician After adjustment, always confirm the amount of distraction by x-ray imaging. Reference figure 5B. OM0000-C, Page 10 of 25

11 Standard Rod Offset Rod Implant Magnet Distraction Length Implant Magnet 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 an emergency where the ERC fails to stop, lift the ERC off of the patient. This will undo the magnetic coupling between the External Remote Controller and the implant and will stop the adjustment. Place the External Remote Controller in its protective case and then unplug the device from its power source. OM0000-C, Page 11 of 25

12 7. Controls Layout: 7.1. Magnetic Hand Piece: The Magnetic Hand Piece has two handles for positioning the unit over the implant. The Magnetic Hand Piece also has two momentary push buttons. One push button for extending and the other for retracting the implant. Pressing and holding a push button causes the ERC to run in the desired direction. Releasing the button causes the ERC to stop. Pressing both buttons simultaneously also causes the ERC to stop. Reference figure 7A. 1 4 Implant Locating Window 3 2 Figure 7A, Magnetic Hand Piece 1 Left handle. 2 Right handle. 3 Extend push button. 4 Retract push button. OM0000-C, Page 12 of 25

13 7.2. Control Panel: Figure 7B shows the layout of the control panel Figure 7B, Control Panel Description: 1 Backlit LCD display. 2 Upper Left Soft Key The function of this key varies by screen. 3 Upper Right Soft Key The function of this key varies by screen. 4 Lower Left Soft Key The function of this key varies by screen. 5 Lower Right Soft Key The function of this key varies by screen. 6 The ESC (escape) key cancels the current operation. 7 The four arrow keys are used to move the cursor around the screen. 8 The ENTER key is used to edit / enter data. 9 The Function keys (F1-F10) are used to navigate between display screens and for data entry. OM0000-C, Page 13 of 25

14 8. Screen Navigation: The ERC has several screens used for various functions. The function and use of each screen is described in detail in this section Information Screen (F5): Press the F5 key to access the Information Screen shown in figure 8A. This screen displays specific information about the External Remote Controller. It displays the software version. It also displays an odometer reading that keeps tract of the total number of millimeters of use. Figure 8A, Information Screen OM0000-C, Page 14 of 25

15 8.2. Main Operating Screen (F6): Press the F6 key to access the Main Operating screen shown in figure 8B. This screen displays information concerning the adjustment of the implant. 1 RESET MODE 2 3 Figure 8B, Main Operating Screen 1 The top line displays the current status of the system. The following messages are displayed. Ellipse Tech The ERC is idle. Increasing The implant is increasing in length. Decreasing The implant is decreasing in length. At Minimum Limit The absolute length of the implant has reached its lower limit. At Maximum Limit The absolute length of the implant has reached its upper limit. 2 The second line displays the current ERC mode. The ERC can be placed into one of two different operating modes: Continuous Mode or Incremental Mode. To toggle between the two modes press the upper right (MODE) soft key. Continuous Mode: Cont. Mode Continuous mode allows the ERC 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. OM0000-C, Page 15 of 25

16 To reset the value to zero, simply press the upper left (RESET) soft key. To enter a specific starting value, use the arrow keys to position the dashed box cursor over the value. Press the ENTER key to select. The displayed value will change to a dark background when selected. Use the F1 F10 keys to input the desired value. Press the ENTER key again to accept the new value or press the ESC key to abort the new entry. Values from 25.0 to mm may be entered. Incremental Mode: Inc. Mode Incremental mode allows the user to input a fixed set point distance to move the implant. If a positive increment value is set, the ERC will automatically stop when the implant has extended to the set point value. If a negative increment value is set, the ERC will automatically stop when the implant has retracted to the set point value. To edit the increment set point value, use the arrow keys to position the dashed box cursor over the value. Press the ENTER key to select. The displayed value will change to a dark background when selected. Use the F1 F10 keys to input the desired value. Use the Up Arrow key to change the sign (+/-) if needed. Press the ENTER key again to accept the new value or press the ESC key to abort the new entry. Incremental values from 25.0 to mm may be entered. For positive increment values, press and hold the Extend Hand Piece push button. The ERC will extend the implant until the set point value is reached and then it will stop automatically. Note that releasing the Extend button always stops the adjustment. The set point value displayed will approach zero. Press the RESET button to reset the displayed value back to the set point. Note that the ERC will not extend until the set point is reset. However, the ERC will retract without limit as long as the retract button is pressed. For negative increment values, press and hold the Retract Hand Piece push button. The ERC will retract the implant until the set point value is reached and then it will stop automatically. Note that releasing the Retract button always stops the adjustment. The set point value displayed will approach zero. Press the RESET button to reset the displayed value back to the set point. Note that the ERC will not retract until the set point is reset. However, the ERC will extend without limit as long as the extend button is pressed. The bar graph below the increment value displays the percentage of the increment achieved. An all white bar indicates 0% increment and an all black bar indicates 100% increment. 3 The third line displays the Absolute Implant Distraction Length, Abs. Length:. This value increases and decreases with the implant as the ERC adjusts it. The bar graph below the absolute length indicates the percentage extended. An all white bar indicates 0% extension and an all black bar indicates 100% extension. To edit the absolute length value, use the arrow keys to position the dashed box cursor over the value. Press the ENTER key to select. The displayed value will change to a dark OM0000-C, Page 16 of 25

17 background when selected. Use the F1 F10 keys to input the desired value. Press the ENTER key again to accept the new value or press the ESC key to abort the new entry. Absolute lengths from 0.0 to 48.0 mm may be entered. 9. Alarm Messages: Several alarm messages may occur if the unit malfunctions. The alarm messages are described in the following section Alarm 00: Input Fault, I3 Input Fault, I3 ALARM 00 Alm Rst One of the motor monitoring leads is not functioning properly. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen Alarm 01: Input Fault, I4 Input Fault, I4 ALARM 01 Alm Rst One of the motor monitoring leads is not functioning properly. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen Alarm 02: Motor Direction Fault Not Extending Motor Direction Fault Not Extending ALARM 02 Alm Rst The unit is not extending the implant as requested. It is turning the wrong direction and retracting the implant. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen. OM0000-C, Page 17 of 25

18 9.4. Alarm 03: Motor Direction Fault Not Retracting Motor Direction Fault Not Retracting ALARM 03 Alm Rst The unit is not retracting the implant as requested. It is turning the wrong direction and extending the implant. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen Alarm 04: Motor Runaway! Extending Motor Runaway! Extending ALARM 04 Alm Rst The motor is running without operator input. Remove the Hand Piece from the patient, place it in its protective case, and unplug it from the power source. Return the unit for service Alarm 05: Motor Runaway! Retracting Motor Runaway! Retracting ALARM 05 Alm Rst The motor is running without operator input. Remove the Hand Piece from the patient, place it in its protective case, and unplug it from the power source. Return the unit for service. OM0000-C, Page 18 of 25

19 9.7. Alarm 06: Motor Ground Fault Motor Ground Fault ALARM 06 Alm Rst The motor common (-) potential is lost. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen Alarm 07: Motor Encoder Fault Motor Encoder Fault ALARM 07 Alm Rst The motor encoder is not pulsing properly. Return the unit for service. Press the Alarm Reset button (lower right soft key) to return to the previous screen. OM0000-C, Page 19 of 25

20 10. Maintenance & Cleaning: * 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 * WARNING * Only use the supplied power cord or an equivalent cord rated for 10 Amps minimum. Replacement power cords are available from Ellipse Technologies A field replaceable fuse is accessible from the outside of the control box between the cords. Fuse Rating: 250 V, 1.6 A, Type F * WARNING * For continuous protection against fire, replace the fuse with the same type and rating. Always disconnect the device from its power source when replacing the fuse To clean the external surfaces of the ERC, wipe with a water moistened cloth. Do not submerge any component of the ERC in liquid. Severe personal injury or permanent damage to the ERC may result. 11. Disposal: Do not dispose of the External Remote Controller in the trash. Please return it in its protective case to Ellipse Technologies or call for disposal directions. Do not incinerate this equipment. The External Remote Controller contains rare earth magnets which burn extremely hot if ignited. OM0000-C, Page 20 of 25

21 12. Specifications: Description Rating Units Display Accruacy 1 ±10% + ±0.3 mm Operating Temperature (50 104) o C ( o F) Operating Relative Humidity % Storage Temperature (14 140) o C ( o F) Storage Relative Humidity 5 95 (Non Condensing) % Input Power Voltage (Single Phase) VAC Input Power Frequency 50 / 60 Hz Input Power Current (Maximum) 2.3 A Weight: Magnetic Hand Piece Only 3.3 (7.3) kg (lbs) External Remote Controller 5.1 (11.2) kg (lbs) Device with Carrying Case 10.1 (22.3) kg (lbs) Maximum Continuous On Time 30 Minutes On Time / Off Time 10 / 90 % Description Rating Classification for Shock Class II No reliance on protective earth, double insulated. Protection Applied Part Type Shock Type BF (Basic Floating). & Leakage Current Defibrillation Rating. Not Defibrillator Proof Anesthetic Use. Do NOT use this equipment in the presents of flammable anesthetics. (Neither AP nor APG) Ingress Protection. IPXO Method of Sterilization. Non-Sterile High Altitude Use. Not rated for use over 3000 m (9842 ft) altitude Pollution Degree. Pollution Degree 2 (Office Environment) Over Voltage Category. Category II. Note 1: * WARNING * Always confirm the predicted implant adjustment length displayed by the External Remote Controller with X-ray measurements. OM0000-C, Page 21 of 25

22 Guidance and manufacturer s declaration electromagnetic emissions Guidance and manufacturer s declaration electromagnetic emissions The model P003 External Remote Controller is intended for use in the electromagnetic environment specified below. The customer or the user of the model P003 should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC Voltage fluctuations/ flicker emissions IEC Group 2 Class B Class B Complies The model P003 External Remote Controller must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. The model P003 External Remote Controller is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. OM0000-C, Page 22 of 25

23 Guidance and manufacturer s declaration electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity The model P003 External Remote Controller is intended for use in the electromagnetic environment specified below. The customer or the user of the model P003 External Remote Controller should assure that it is used in such an environment. Immunity test IEC Compliance level Electromagnetic environment Electrostatic discharge (ESD) IEC Electrical fast transient/burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines IEC Power frequency (50/60 Hz) magnetic field IEC test level ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/output lines ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5 s ± 6 kv contact ± 8 kv air ± 2 kv for power supply lines ± 1 kv for input/output lines ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth <5 % U T (>95 % dip in U T ) for 0.5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5 s guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the model P003 External Remote Controller requires continued operation during power mains interruptions, it is recommended that the model P003 External Remote Controller be powered from an uninterruptible power supply or a battery. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE U T is the a.c. mains voltage prior to application of the test level. OM0000-C, Page 23 of 25

24 Guidance and manufacturer s declaration electromagnetic immunity Guidance and manufacturer s declaration electromagnetic immunity The model P003 External Remote Controller is intended for use in the electromagnetic environment specified below. The customer or the user of the model P003 External Remote Controller should assure that it is used in such an environment. IMMUNITY test Conducted RF IEC IEC TEST LEVEL 3 Vrms 150 khz to 80 MHz Compliance level 3 Vrms P Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of model P003 External Remote Controller, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1. 2 Radiated RF IEC V/m 80 MHz to 2.5 GHz 3 V/m d = 1. 2 P 80 MHz to 800 MHz d = 2. 3 P 800MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (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 affected by absorption and reflection from structures, objects, and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model P003 External Remote Controller is used exceeds the applicable RF compliance level above, the model P003 External Remote Controller should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating model P003 External Remote Controller. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. OM0000-C, Page 24 of 25

25 Recommended separation distances between portable and mobile RF communications equipment Recommended separation distances between portable and mobile RF communications equipment and the model P003 External Remote Controller The model P003 External Remote Controller is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model P003 External Remote Controller can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model P003 External Remote Controller as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1. 2 P d = 1. 2 P d = 2. 3 P For 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, 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 guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people EC REP MediTech Strategic Consultants B.V. Maastrichterlann EN Vaals, The Netherlands Fax: Ellipse Technologies Inc Alton Parkway #130 Irvine, CA USA OM0000-C, Page 25 of 25