Nalu
User’s Kit Instructions for Use PN: MA-000007 Rev J
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NALU™ NEUROSTIMULATION SYSTEM
USER INSTRUCTIONS FOR USE
Страница 1: ...Nalu User s Kit Instructions for Use PN MA 000007 Rev J Page 1 of 80 NALU NEUROSTIMULATION SYSTEM USER INSTRUCTIONS FOR USE...
Страница 2: ...date Date after which the medical device is not to be used ISO 15223 1 5 1 4 Batch code Manufacturer s batch code so that the batch or lot can be identified ISO 15223 1 5 1 5 Catalogue number Manufac...
Страница 3: ...Do not re use A medical device that is intended for one use or for use on a single patient during a single procedure ISO 15223 1 5 4 2 Consult instructions for use Indicates the need for the user to...
Страница 4: ...1 2 2007 5 1 1 Prescription use only Caution Law prohibits dispensing without prescription 21 CFR 801 109 N A Quantity Indicates the total number of products provided in a package N A N A Serial Numb...
Страница 5: ...r a Class B digital device pursuant to part 15 of the FCC Rules 47 CFR 2 926 N A Do not throw in the trash This product shall not be treated as household waste Instead it is the user s responsibility...
Страница 6: ...tion 10 Implantable Pulse Generator 11 Leads 11 Therapy Disc 11 Trial System Description 11 Leads 11 Trial Therapy Disc 11 Lead Extension 12 Electrode Interfacing Cable 12 System Accessories 12 Adhesi...
Страница 7: ...rapy Disc 30 Decreasing Stimulation from the Therapy Disc 30 Changing the Stimulation Program from the Therapy Disc 31 Low Battery Mode on the Therapy Disc 31 Powering OFF the Therapy Disc 32 Adhesive...
Страница 8: ...Therapy Disc 43 Removing the Therapy Disc 43 Powering Down the Charger 43 Troubleshooting 44 Safety and Technical Checks 46 Cleaning Your Device 46 Cleaning the Therapy Disc 46 Cleaning the Trial The...
Страница 9: ...cy RF and Wireless Data Parameters 56 Quality of Service for Wireless Technology 57 Troubleshooting for Wireless and Coexistence Issues 58 Statement of FCC Compliance 59 Magnetic Resonance Imaging MRI...
Страница 10: ...for pain management in adults who have severe intractable chronic pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary a...
Страница 11: ...lantable Pulse Generator The Therapy Disc is positioned externally over the implant using an adhesive retention clip or textile belt and may be controlled using integrated buttons or via the Nalu Remo...
Страница 12: ...em Accessories Adhesive Clip The adhesive clip holds the Therapy Disc in place over the Implantable Pulse Generator location Relief Belt The relief belt holds the Therapy Disc in place over the Implan...
Страница 13: ...atients who regularly work in environments with elevated levels of non ionizing radiation should not be implanted with the device The energy in high level areas can be transferred through the device a...
Страница 14: ...herapy Disc needs to be reprogrammed Unexpected changes in stimulation causing a momentary increase in stimulation or intermittent stimulation Some users have described a jolting or shocking sensation...
Страница 15: ...specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation...
Страница 16: ...cal tests or treatments please share the following Warnings with your clinician Active Implantable or Body Worn Medical Devices Safety has not been established for users who use the Nalu Neurostimulat...
Страница 17: ...Safety has not been established for CT scanning of users with a Nalu Neurostimulation System X rays from the scan could cause unintended shocks or malfunctions of the System and may not be immediately...
Страница 18: ...r near the device Medical Devices Therapies The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Nalu Implantable Pulse Generator particularly if...
Страница 19: ...radiation therapy is required the area over the Nalu Implantable Pulse Generator should be shielded with Lead Equipment should be set to the lowest energy setting clinically indicated Instruct users t...
Страница 20: ...pering Do not modify or tamper with any component of the Nalu Neurostimulation System Tampering with the device could result in harm If the device is not working properly contact your clinician for he...
Страница 21: ...ocedures contact your clinician to determine if the procedure will cause damage to the user or to the System When you are considering additional medical treatments please share the following Precautio...
Страница 22: ...peratures listed on product packaging Exceeding the storage temperature can affect the performance of the device Random Component Failure Although unlikely a failure of the Nalu Neurostimulation Syste...
Страница 23: ...the device Before diving or using a hyperbaric chamber discuss the effects of high pressure with the clinician Do not dive or enter hyperbaric chambers with the Therapy Disc Remote Control Interferen...
Страница 24: ...ulation or untoward stimulation induced dysesthesias Allergic or rejection reaction to the anesthesia implanted components or external components Reaction to the selected antibiotics or to the Nalu de...
Страница 25: ...wall stimulation muscle stimulation tremor dyskinesia superficial pain cramping light headedness and metallic taste Weakness Numbness Clumsiness Tissue damage Nerve damage Paralysis Swelling Sensory l...
Страница 26: ...mpression and paralysis requiring surgical intervention Time to onset can range from days to many years after implant Arrhythmia Cardiac arrest Intracranial hypotension Fracture of the lead s or failu...
Страница 27: ...ovided with two Therapy Discs in the initial Nalu User s Kit one to be used while the other is charging The Trial Therapy Disc has a wired connection to the lead or lead extension to provide stimulati...
Страница 28: ...ON the Therapy Disc 1 Press and release the ON OFF Program button 2 Listen and watch 3 The buzzer will beep and the white LED will blink to indicate battery level white blinks beeps Battery Level 4 Fu...
Страница 29: ...and Idle programs An Idle program is essentially a period of no stimulation Connecting the Therapy Disc with the Nalu Implantable Pulse Generator 1 Place the Therapy Disc over the implant 2 Three 3 s...
Страница 30: ...he Up button 2 The green LED will blink after each button press Maximum Stimulation When at the maximum level of stimulation further attempts to increase stimulation will cause the buzzer to beep twic...
Страница 31: ...will be Program 1 or the schedule mode if available NOTE When the Therapy Disc is cycled back to the Schedule mode the Schedule will resume from the last executed stimulation program NOTE The maximum...
Страница 32: ...d 2 Press and hold the ON OFF Program button 3 The white LED will blink while the Therapy Disc shuts down completely The white LED will stop blinking after the Therapy Disc has powered off NOTE If the...
Страница 33: ...ion failed Short Press on the Up Button 1 green blink per press Stimulation increased 2 short orange blinks 2 short beeps Maximum stimulation level reached Long Press on the Up Button Dismiss reactiva...
Страница 34: ...Action Time Short Press on Any Button Press for less than one 1 second Long Press on Any Button Press for more than one 1 second Therapy Disc Response Time Short Beeps Blinks Last for 0 1 seconds whe...
Страница 35: ...lips 34005 002 If you experience moderate to severe skin reactions from the H100 Adhesive Clip switch to the H300 Adhesive Clip 34005 003 If the H100 Adhesive Clip is not sticky enough switch to the H...
Страница 36: ...place your index finger through the center hole The clip should be held as shown in Figure 6 3 Use your inserted index finger and locate the implant site as shown in Figure 7 4 Once the implant site h...
Страница 37: ...skin as shown in Figure 8 Removing Therapy Disc 1 Grip the sides of the Therapy Disc 2 Gently lift the Therapy Disc away from the surface of your skin and out of the clip as shown in Figure 9 Adhesive...
Страница 38: ...Discard the used clip 6 It is recommended that any residue be cleaned using commercially available wipes and sprays designed to work with hydro 7 colloid adhesives Do not use alcohol to clean the res...
Страница 39: ...so that the Therapy Disc buttons are facing away from your skin 2 Adjust the belt tightness using the Velcro straps 3 Rotate the belt to position the device over the implant site Removing the Relief...
Страница 40: ...ons for Use PN MA 000007 Rev J Page 40 of 80 LIMB CUFF INSTRUCTIONS FOR USE Placing the device in the limb cuff 1 Insert the device in the limb cuff pocket as shown 1 2 Secure the device in the pocket...
Страница 41: ...wrap the strap around your limb 2 Place the strap through the loop and pull the strap to tighten the limb cuff 3 Secure the limb cuff in place using the Velcro tab Removing the limb cuff 1 Undo the V...
Страница 42: ...er can be used for both the Permanent and Trial Therapy Discs When battery is fully charged the Therapy Disc is may provide therapy from 8 40 hours nominal 16 hours depending on location of Therapy Di...
Страница 43: ...illuminated blue meaning that the charger is ready for use Charging the Therapy Disc 1 Orient and place the Therapy Disc on the charger using the Nalu logo and Nalu n features as guides to help with...
Страница 44: ...e Therapy Disc from your body Unplug the Trial Therapy Disc Reduce the stimulation from the Remote Control Application or the Therapy Disc No Stimulation Stimulation is off Turn the Therapy Disc power...
Страница 45: ...apy Disc becomes wet The Trial Therapy Disc is not waterproof Discontinue use of the device and contact your Nalu representative Adhesive Clip Problem Causes Possible Actions Adhesive is Too Strong Th...
Страница 46: ...maintenance of the Therapy Disc are not required The Therapy Disc contains no user serviceable parts If repair or service is needed contact your clinician or a Nalu representative for a replacement Re...
Страница 47: ...gle use adhesive clips adhere to local disposal requirements regulations ENVIRONMENTAL CONDITIONS FOR STORAGE AND OPERATION Therapy Disc Storage Temperature 18 C to 60 C Operating Temperature 0 C to 4...
Страница 48: ...UR CLINICIAN Contact your clinician if any of the following events occur You have pain redness or swelling later than six 6 weeks after the implant procedure The stimulation is causing you to have pai...
Страница 49: ...stimulation User s Kit 34001 001 Therapy Disc 2 34007 Relief Belt 1 43001 Therapy Disc Charger 1 43002 Therapy Disc Charger Wall Adapter US Type A 1 43006 Therapy Disc Charger USB Cable 1 43007 Equipm...
Страница 50: ...02 Therapy Disc Charger Wall Adapter US Type A 1 43006 Therapy Disc Charger USB Cable 1 43007 Equipment Bag 1 MA 000007 Nalu Neurostimulation User Instructions for Use 1 74007 001 34005 001 Adhesive C...
Страница 51: ...ial Polycarbonate Acrylonitrile Butadiene Styrene Diameter 3 76 mm Thickness 0 6 15 mm Weight 100g Trial Therapy Disc 34002 Description Case Material Polycarbonate Acrylonitrile Butadiene Styrene Diam...
Страница 52: ...Cable 34003 Unit Housing Material Acrylonitrile Butadiene Styrene Length 7 69 cm Description Cable Material Polyvinyl Chloride Connector Micro HDMI Adhesive Clip Pack H200 34005 001 Description Clip M...
Страница 53: ...Clip Description Clip Material Polypropylene Material Polypropylene Diameter 3 76 mm Diameter 3 76 mm Description Adhesive Description Adhesive Material Hydrocolloid Material Hydrocolloid Weight 9 g W...
Страница 54: ...Rev J Page 54 of 80 Relief Belt 34007 Description Belt Description Buckle Material Neoprene Material Acetal Length 48 1 cm Weight 69 g Limb Cuff 34009 Description Cuff Description Velcro Material Neo...
Страница 55: ...ev J Page 55 of 80 Limb Cuff Large 34011 Description Cuff Description Velcro Material Neoprene Material Acetal Length 5 64 cm Weight 40 g Therapy Disc Charger 43001 Description Case Material Acrylonit...
Страница 56: ...believed to be compatible with regulations worldwide Parameter Band Description Frequency BLE 2 402 2 480 MHz data ISM 40 66 40 70 MHz power and data transfer Bandwidth BLE 2 MHz ISM 1 MHz low depth...
Страница 57: ...t operating room recovery room and home environment After the Remote Control App is paired with a Therapy Disc the Bluetooth wireless technology symbol is visible on the remote control app in the uppe...
Страница 58: ...ss technology A proprietary algorithm that detects and prevents an unauthorized user from attempting to communicate with the Therapy Disc Troubleshooting for Wireless and Coexistence Issues If you exp...
Страница 59: ...ipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or...
Страница 60: ...electromagnetic energy in order to perform its intended function Nearby equipment may be affected RF Emissions CISPR 11 Class B The Nalu Neurostimulation System is suitable for use in all establishmen...
Страница 61: ...kV contact 8 kV air 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 IEC 61000...
Страница 62: ...ances are controlled The customer or user of the Nalu Neurostimulation System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communicati...
Страница 63: ...Nalu Anchor Model 13001 WARNING Do not bring MR Unsafe components of the Nalu Neurostimulation System into the MRI system room It is important to read this entire section prior to conducting or recom...
Страница 64: ...Static magnetic field of 1 5 Tesla T or 3 0 T only Maximum spatial field gradient of 2 000 gauss cm 20 T m 15 minutes of continuous scanning in First level controlled mode for Transmit receive and ex...
Страница 65: ...ifact caused by the Nalu Neurostimulation System extends approximately 10 mm from this implant when imaged using a gradient echo pulse sequence and a 3 T MRI system Important Note An MRI examination p...
Страница 66: ...tted using a 1 5 T or 3 T MRI system and a transmit receive RF head coil No part of the implanted Nalu Neurostimulation System may be within the transmit receive RF head coil All other aforementioned...
Страница 67: ...ser s Kit Instructions for Use PN MA 000007 Rev J Page 67 of 80 Extremity MRI Examinations Transmit receive RF knee coil 1 5 T or 3 T MR system Patient implanted with Nalu Neurostimulation System Figu...
Страница 68: ...Nalu User s Kit Instructions for Use PN MA 000007 Rev J Page 68 of 80 1 5 T or 3 T MR system Patient Implanted with Nalu Neurostimulation System Transmit receive RF foot ankle coil Figure 2b...
Страница 69: ...n System may be within the transmit receive RF extremity coil All other aforementioned conditions must be carefully followed a Represents an MRI of the knee using a transmit receive RF knee coil b Rep...
Страница 70: ...th stimulating contacts in the vicinity of T8 T10 per Figure 3 anchors Model 13001 may be present A patient with an implantable pulse generator leads and anchor can be scanned safety in an MRI system...
Страница 71: ...he Nalu Neurostimulation System extends approximately 10 mm from this implant when imaged using a gradient echo pulse sequence and a 3 T MRI system Important Note An MRI examination performed outside...
Страница 72: ...al space with stimulating contacts in the vicinity of T8 T10 per Figure 3 anchors Model 13001 may be present ZONE A The center of the bore is below the bottom of the buttocks or above the bottom of th...
Страница 73: ...Nalu User s Kit Instructions for Use PN MA 000007 Rev J Page 73 of 80 Acceptable MRI Scenarios Chart...
Страница 74: ...antable Pulse Generator i e the patient has a percutaneously implanted lead and an external Trial Therapy Disc Model 34002 Do not perform MRI on a patient that has any other active medical implants Pr...
Страница 75: ...oom turn the Therapy Disc on and verify connection to the Implantable Pulse Generator Perform an impedance check MAGNETIC RESONANCE IMAGING MRI SAFETY INFORMATION PNS PNS Head and Extremities scan usi...
Страница 76: ...tremities scan using a transmit receive head and extremities coil see page 64 SCS Scan using a whole body RF transmit coil See page 70 PNS Head and Extremities scan using a transmit receive head and e...
Страница 77: ...eive RF coil that includes a knee foot ankle or wrist transmit receive RF coil No part of the implanted Nalu Neurostimulation System may be within these transmit receive RF coils Under the scan condit...
Страница 78: ...0 or Model 11002 040 IPG with integrated lead s can undergo an MRI examination under the specified conditions MRI is only permitted using an MRI system operating at 1 5 T 64 MHz or 3 T 128 MHz Use onl...
Страница 79: ...if the impedance is greater than 10 k Remove the Therapy Disc from the patient before entering the MRI system room Do not conduct an MRI examination if the 40 cm implanted lead s are not connected to...
Страница 80: ...ort nalumed com www nalumed com This product can expose you to chemicals including ethylene oxide which is known to the State of California to cause cancer and birth defect or other reproductive harm...
