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Nalu Medical Nalu Neurostimulation System User Instructions For Use

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Nalu™ Medical, Inc.
NALU™ NEUROSTIMULATION SYSTEM
USER INSTRUCTIONS FOR USE
Nalu User's Kit Instructions for Use PN: MA-000007 Rev C

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Summary of Contents for Nalu Medical Nalu Neurostimulation System

  • Page 1 Nalu™ Medical, Inc. NALU™ NEUROSTIMULATION SYSTEM USER INSTRUCTIONS FOR USE Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C...
  • Page 2 EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE Refer to the appropriate product for symbols that apply. Symbol Title Explanation Standard Reference Medical device manufacturer, as Manufacturer ISO 15223-1 5.1.1 defined in EU Directive 93/42/EEC Date when the medical device was Date of manufacture ISO 15223-1 5.1.3...
  • Page 3 15 of the FCC Rules. This product shall not be treated as household waste. Instead it is the user’s responsibility to return this product to Nalu Medical for reprocessing. By ensuring that this product is BS EN 50419 Marking of...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Introduction ............................6 Indications for Use ..........................6 Permanently Implanted System Description ..................6 Implantable Pulse Generator ......................6 Leads ..............................6 Therapy Disc ............................6 Trial System Description ........................6 Leads ..............................7 Trial Therapy Disc ..........................7 Lead Extension ..........................
  • Page 5 Removing Therapy Disc ........................21 Adhesive Wear Time ........................... 21 Removing the Clip ..........................21 Relief Belt .............................. 22 Description ............................22 Placing the Therapy Disc in the Relief Belt Pocket ................22 Removing the Therapy Disc from the Relief Belt Pocket ..............22 Wearing the Relief Belt ........................

  • Page 6: Introduction

    The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

  • Page 7: Leads

    Exposure to shortwave, microwave, or ultrasound diathermy – Diathermy should not be operated within the vicinity of a patient implanted with a Nalu Neurostimulation System or when wearing a Therapy Disc. The energy from diathermy can be transferred through the stimulator and cause tissue damage, resulting in severe injury.

  • Page 8: Warnings

    In rare cases, as a result of the unexpected changes in stimulation, users have fallen down and been injured. If you suspect that your Nalu Neurostimulation System is being affected by EMI, then you should: •...
  • Page 9 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Nalu Neurostimulation System. Otherwise, performance degradation of the equipment might occur. Machinery or Heavy Equipment—Machinery and heavy equipment (including vehicles) should not be operated while using the Nalu Neurostimulation System.
  • Page 10 a. Remove the Therapy Disc from the CT scan range. b. Minimize X-ray exposure to the implanted device by: c. Using the lowest possible X-ray tube current consistent with obtaining the required image quality. d. Making sure that the X-ray beam is not placed over the Nalu Implantable Pulse Generator for more than a few seconds.

  • Page 11: Precautions

    Tampering - 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 help.
  • Page 12 Clean the Therapy Disc – When needed, clean the outside of the Therapy Disc with a damp cloth to prevent dust and dirt. Storage Temperatures – The Nalu Neurostimulation System should be kept within the storage temperatures listed on product packaging. Exceeding the storage temperature can affect the performance of the device.

  • Page 13: Adverse Event Summary

    Re-establish the Bluetooth link with the Therapy Disc through pairing. Reopen the Nalu Remote Control application and resume the therapy. Adverse Environments – Any user with a Nalu Neurostimulation System should seek medical guidance before entering environments which could adversely affect the operation of the Nalu Neurostimulation System, including areas protected by a warning against entry by users.
  • Page 14 There may be changes in the level of pain control over time. Notice: In the event of any serious incident that has occurred in relation to the Nalu Neurostimulation System, the user should report the incident to Nalu Medical at +1.800.618.3402 or visit www.nalumed.com.
  • Page 15 Page 15 of 44 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C...

  • Page 16: Therapy Disc

    THERAPY DISC Description The Therapy Disc is a part of the Nalu Neurostimulation System that wirelessly powers and sends stimulation commands to the Nalu Implantable Pulse Generator. The Therapy Disc is positioned over the implant using an Adhesive Retention Clip or Relief Belt and may be controlled using integrated buttons or via a remote-control application (see Nalu Remote Control Application Instructions for Use for details).

  • Page 17: Powering On The Therapy Disc

    Powering 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 Fully charged ¾...

  • Page 18: Increasing Stimulation From The Therapy Disc

    Increasing Stimulation from the Therapy Disc 1. Press and release the 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 twice and the orange LED to blink twice. Decreasing Stimulation from the Therapy Disc 1.
  • Page 19 Below is a table with button actions and the meaning of the corresponding LED or buzzer sound. Action LED indication Buzzer indication Meaning Press ON / OFF 4 white blinks 4 beeps Battery fully charged. Program Button to 3 white blinks 3 beeps Battery ¾...

  • Page 20: Adhesive Clip

    ADHESIVE CLIP Figure 2: Clip Figure 4: Clip and Therapy Disc Figure 3: Clip (Back) Description The single-use Adhesive Clip is designed to hold the Therapy Disc on the body using a skin friendly adhesive. The Adhesive Clip is placed over the implant and the Therapy Disc is inserted into the clip. The Adhesive Clip is not intended to be reused.

  • Page 21: Placing The Therapy Disc Into The Adhesive Clip

    3. Use your inserted index finger and locate the implant site, as shown in Figure 7. 4. Once the implant site has been located, press the clip against your skin, ensuring the heel (where the therapy disc sits) is towards the bottom. Figure 7 Locate Implant Placing the Therapy Disc into the Adhesive Clip 1.

  • Page 22: Relief Belt

    RELIEF BELT Description The relief belt is an alternative to the adhesive clip for holding the therapy disc in place on the body. The device is inserted in the belt pocket and positioned over the implant. Placing the Therapy Disc in the Relief Belt Pocket 1.

  • Page 23: Limb Cuff Instructions For Use

    LIMB CUFF INSTRUCTIONS FOR USE Placing the device in the limb cuff 1. Insert the device in the limb cuff pocket as shown. 2. Secure the device in the pocket using the snap button. Placing the limb cuff on target location 1.

  • Page 24: Charger

    CHARGER Description The charger charges the Therapy Disc battery. It takes approximately six (6) hours to fully charge the Therapy Disc from full discharge. The charger 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 Disc, stimulation level, and participant use.

  • Page 25: Powering Down The Charger

    Powering Down the Charger 1. Disconnect the USB cable from the Charger. LED color Device status Blue Charger ready for use Orange Device charging Green Device fully charged TROUBLESHOOTING Therapy Disc Problem Causes Possible Actions Uncomfortable Stimulation The selected parameters are not Remove the Therapy Disc from your body.

  • Page 26: Safety And Technical Checks

    Adhesive Keeps Falling Off Improper wear period. Reduce your wear time. Replace the adhesive clip before it falls off. Talk to your Nalu representative about switching to a different adhesive. Adhesive Causing Skin Breakage The adhesive was removed too Increase your wear time and remove the early.

  • Page 27: Environmental Conditions For Storage And Operation

    ENVIRONMENTAL CONDITIONS FOR STORAGE AND OPERATION Therapy Disc Storage Temperature -18°C to 60°C Operating Temperature 0°C to 45°C Humidity < 90% Pressure 70 kPa – 107 kPa Therapy Disc Charger Storage Temperature -18°C to 60°C Operating Temperature 0°C to 40°C Humidity <...

  • Page 28: Kit Contents

    KIT CONTENTS Model Number Description Quantity 74001 Nalu Neurostimulation User’s Kit 34001-001 Therapy Disc 34007 Relief Belt 43001 Therapy Disc Charger 43002 Therapy Disc Charger Wall Adapter (US Type A) 43003 Therapy Disc Charger Wall Adapter (EU Type C) 43004 Therapy Disc Charger Wall Adapter (UK Type G) 43005 Therapy Disc Charger Wall Adapter (AUS Type I)

  • Page 29: Device Specifications

    DEVICE SPECIFICATIONS Therapy Disc – # 34001-001 Description: Case Polycarbonate/Acrylonitrile Butadiene Material: Styrene Diameter: 3” / 76 mm Thickness: 0.6” / 15 mm Weight: <100g Trial Therapy Disc – # 34002 Description: Case Polycarbonate/Acrylonitrile Butadiene Material: Styrene Diameter: 3” / 76 mm Thickness: 0.6”...
  • Page 30 Adhesive Clip Pack (H200)– # 34005-001 Description: Clip Material: Polypropylene Diameter: 3”/ 76 mm Description: Adhesive Material: Hydrocolloid Weight: Adhesive Clip Pack (H300)– # 34005-003 Adhesive Clip Pack (H100)– # 34005-002 Description: Clip Description: Clip Material: Polypropylene Material: Polypropylene Diameter: 3”/ 76 mm Diameter: 3”/ 76 mm...
  • Page 31 Limb Cuff – # 34009 Description: Cuff Description: Velcro Material: Neoprene Material: Acetal Length: 18”/ 46 cm Weight: 33 g Limb Cuff, Large – # 34011 Description: Cuff Description: Velcro Material: Neoprene Material: Acetal Length: 25”/ 64 cm Weight: 40 g Therapy Disc Charger –...

  • Page 32: Radiofrequency (Rf) And Wireless Data Parameters

    Radiofrequency (RF) and Wireless Data Parameters Bluetooth ® Low Energy (BLE)– Clinician Programmer, Remote Control, Therapy Disc Industrial, Scientific, & Medical (ISM) – Therapy Disc, Nalu Implantable Pulse Generator Nalu’s reliance on a single ISM band and Bluetooth for system operation are believed to be compatible with regulations worldwide.

  • Page 33: Troubleshooting For Wireless And Coexistence Issues

    Wireless Security Measures The wireless signals are secured through device system design that includes the following: • The Therapy Disc will encrypt its wireless communication. • Only one remote control app may communicate with the Therapy Disc at the same time. •...
  • Page 34 GUIDANCE AND MANUFACTURER'S DECLARATION Electromagnetic Emissions The Nalu Neurostimulation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Nalu Neurostimulation System should assure that it is used in such an environment Emissions test Compliance...

  • Page 35: Magnetic Resonance Imaging (Mri) Safety Information (Scs)

    It is important to read this entire section prior to conducting or recommending an MRI examination on a user implanted with the Nalu Neurostimulation System. These instructions only apply to the Nalu Neurostimulation System and do not apply to other products. If you have any questions, please contact Nalu Medical or visit www.nalumed.com.
  • Page 36 • For extremity MRI examinations, only use a transmit/receive 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 one of these transmit/receive RF coils. Under the scan conditions defined above, the Nalu Neurostimulation System is expected to produce a maximum temperature rise of 2.5ºC after 15 minutes of continuous scanning (i.e., per pulse sequence) when using one of...
  • Page 37 Figure 1. Head/brain MRI examinations are permitted 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 conditions must be carefully followed.
  • Page 38 Extremity MRI Examinations Patient implanted with Nalu Neurostimulation System Transmit/receive 1.5 T or 3 T MR system RF knee coil Figure 2a Page 38 of 44 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C...
  • Page 39 Patient Implanted with Nalu Neurostimulation System 1.5 T or 3 T MR system Transmit/receive RF foot/ankle coil Figure 2b Page 39 of 44 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C...
  • Page 40 Figure 2. Extremity MRI examinations are permitted using a 1.5 T or 3 T MRI system and a transmit/receive RF extremity coil (e.g., knee, foot/ankle, wrist). No part of the implanted Nalu Neurostimulation 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.

  • Page 41: Magnetic Resonance Imaging (Mri) Safety Information (Pns)

    Perform an impedance check. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION (PNS) All of the components of the Nalu Neurostimulation System are MR Unsafe except for the following: • Nalu Implantable Pulse Generators (Dual Integrated Model 11002-040, Single Integrated Model 11001- 040) •...
  • Page 42 It is important to read this entire section prior to conducting or recommending an MRI examination on a user implanted with the Nalu Neurostimulation System. These instructions only apply to the Nalu Neurostimulation System and do not apply to other products. If you have any questions, please contact Nalu Medical or visit www.nalumed.com.
  • Page 43 Do not perform MRI on a patient that has any other active medical implants. • No parts of the implanted Nalu Neurostimulation System may be within the transmit/receive RF head coil. Preparation of the Patient Prior to the MRI Examination •...

  • Page 44: Contact Information

    Caution: Federal law restricts this device to sale by or on the order of a physician Nalu is a trademark of Nalu Medical, Inc. Bluetooth is a registered trademark of Bluetooth sig, Inc. Page 44 of 44 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev C...

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