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nalu 12001-040 User Instructions For Use

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NALU™ NEUROSTIMULATION SYSTEM
USER INSTRUCTIONS FOR USE
Nalu User's Kit Instructions for Use PN: MA-000007 Rev J
Page 1 of 80

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  • Page 1 NALU™ NEUROSTIMULATION SYSTEM USER INSTRUCTIONS FOR USE Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 1 of 80...
  • Page 2 Keep away from ISO 15223-1 5.3.2 protection from light sources. sunlight A medical device that needs to Keep dry ISO 15223-1 5.3.4 be protected from moisture. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 2 of 80...
  • Page 3 Caution ISO 15223-1 5.4.4 a variety of reasons, be presented on the medical device itself. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 3 of 80...
  • Page 4 Device contains a type BF applied part to protect you from Protected against shock. The device is internally IEC 60417 5333 electric shock powered and is intended for continuous operation Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 4 of 80...
  • Page 5 The recycling of materials will help to conserve natural resources. For more information about how to return this product for recycling, please contact Nalu Medical. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 5 of 80...

  • Page 6: Table Of Contents

    Limb Cuff ............................... 12 Remote Control ............................. 12 Charger..............................12 Safety Information ............................13 Contraindications ............................13 Warnings ..............................14 Precautions..............................20 Adverse Event Summary ..........................24 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 6 of 80...
  • Page 7 Therapy Disc Features ..........................27 Powering ON the Therapy Disc ......................... 28 Connecting the Therapy Disc with the Nalu Implantable Pulse Generator ..........29 Connecting the Trial Therapy Disc (For the Trial System Only) ..............30 Increasing Stimulation from the Therapy Disc ..................30 Decreasing Stimulation from the Therapy Disc ..................
  • Page 8 Therapy Disc ............................. 47 Therapy Disc Charger ..........................47 Adhesive Clip............................. 47 Identification Card ............................48 When to Call Your Clinician ........................48 Kit Contents ..............................49 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 8 of 80...
  • Page 9 Statement of FCC Compliance ......................59 Magnetic Resonance Imaging (MRI) Safety information (SCS) ............... 63 Magnetic Resonance Imaging (MRI) Safety information (PNS) ............... 75 Contact Information ............................ 80 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 9 of 80...

  • Page 10: Introduction

    Introduction This user manual gives detailed instructions on how to use your Nalu™ Neurostimulation System. It includes instructions for both the Permanently Implanted System and the Trial System. Indications for Use Spinal Cord Stimulation (SCS) This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

  • Page 11: Implantable Pulse Generator

    Nalu Implantable 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 Remote Control application. The service life is 3 years for the Therapy Disc and Charger and 1 year for the Trial Therapy Disc.

  • Page 12: Lead Extension

    The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location. Remote Control The Nalu Remote Control Application is an application that runs on Android and IOS platforms and can be ® optionally used to control and manage Therapy Discs over a secure Bluetooth Low Energy connection.

  • Page 13: Safety Information

    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 14: 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: • For the Therapy Disc – Remove or Turn Off •...
  • Page 15 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.
  • Page 16 Magnetic Resonance Imaging (MRI)—MR Unsafe – For the Nalu Neurostimulation System, the only components that are allowed into the MRI system room are the 40 cm Lead (Model 12001-040), the Nalu Anchor (Model 13001) and the Nalu Implantable Pulse Generators (Model 11001-040, 11002-040, 11003- 002, 11004-002).
  • Page 17 Magnetic resonance imaging (MRI) – MR Conditional – Prior to conducting or recommending an MRI examination on a patient with the Nalu Neurostimulation System, it is important to read and understand the entire section entitled, “MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION” in the Table of Contents, which pertains to performing an MRI examination safely in a patient.
  • Page 18 RF ablation is used, ensure that ablation is not performed over or 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 used in close proximity to the device: •...
  • Page 19 Every effort should be taken to keep fields, including current, radiation, or high-output ultrasonic beams, away from the Implantable Pulse Generator. • If radiation therapy is required, the area over the Nalu Implantable Pulse Generator should be shielded with Lead. •...

  • Page 20: 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 21 Therapy Disc. Use of Another User’s Therapy Disc - Use of another user’s Therapy Disc will not deliver therapy. The therapy programmed is a unique prescription for each user and their specific Nalu Implantable Pulse Generator.
  • Page 22 Exceeding the storage temperature can affect the performance of the device. Random Component Failure – Although unlikely, a failure of the Nalu Neurostimulation System is possible due to random component failure. If any part of your Neurostimulation System stops working or changes how it works, remove the Therapy Disc and contact your Nalu representative.
  • Page 23 Do not dive or enter hyperbaric chambers with the Therapy Disc. Remote Control Interference– If interference is suspected during use of the remote control, confirm that the Bluetooth data transmission is operating properly. If the Nalu Remote Control application is not connecting to the Therapy Disc: Terminate the current stimulation program and shut down the Nalu Remote Control application.

  • Page 24: Adverse Event Summary

    • Allergic or rejection reaction to the anesthesia, implanted components, or external components. • Reaction to the selected antibiotics or to the Nalu device including: rash, diarrhea, abdominal pain, nausea/vomiting, dizziness, headaches, hypersensitivity (allergic) reactions • Undesirable skin problems such as infection, irritation, blistering, tearing or allergic reactions that may occur during the use of any wearable component of the Nalu Neurostimulation System.
  • Page 25 Swelling. • Sensory loss. • Discomfort during the treatment. • Skin erosion around the Nalu Implantable system or at the site of the Nalu wearable devices. • Battery failure • Lead breakage requiring replacement of the Lead. • Electromagnetic interference causing a change in System performance.
  • Page 26 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 27: 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 28: Powering On The Therapy Disc

    3. The buzzer will beep and the white LED will blink to indicate battery level. # white blinks/ beeps Battery Level Fully charged ¾ charged ½ charged ¼ charged Orange Discharged (low battery mode) Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 28 of 80...

  • Page 29: Connecting The Therapy Disc With The Nalu Implantable Pulse Generator

    NOTE: A Schedule can consist of stimulation programs 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) short beeps will sound when the Therapy Disc connects to the implant.

  • Page 30: Connecting The Trial Therapy Disc (For The Trial System Only)

    Minimum Stimulation: When at the minimum level of stimulation, further attempts to reduce stimulation will cause the buzzer to beep twice and the orange LED to blink twice. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 30 of 80...

  • Page 31: Changing The Stimulation Program From The Therapy Disc

    3. To reactivate the low battery indication, press and hold the Up or Down button. The white LED will remain lit while the button is held down. NOTE: Low battery mode disables stimulation, and disables program change and amplitude change buttons. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 31 of 80...

  • Page 32: Powering Off The Therapy Disc

    Schedule was running an Idle program, the Schedule will start from the stimulation program that follows that Idle program when the Disc is powered back on. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 32 of 80...
  • Page 33 Long Press on the White LED blinks for one Device is off. ON / OFF Program second, and then stops Button to Power Off blinking. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 33 of 80...
  • Page 34 ON or OFF. Last for 0.5 seconds when the device is Long Beeps turned ON or OFF. Slow Beeps / Blinks Occur every 1.5 seconds. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 34 of 80...

  • Page 35: Adhesive Clip

    If necessary, trim hair with scissors or small beard trimmer. Do not shave since this can lead to irritation. If desired, commercially available skin barrier wipes and sprays may be used to prep the skin. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 35 of 80...

  • Page 36: Applying The Clip

    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 Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 36 of 80...

  • Page 37: Placing The Therapy Disc Into The Adhesive Clip

    The wear time for the Adhesive Clip varies per activity level and skin type. Wear the clip until it feels like it is coming loose or starts to feel uncomfortable. Figure 10 Remove Adhesive Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 37 of 80...

  • Page 38: Removing The Clip

    Undo the snap button. Slide in the device with the “n” facing down, as shown in Figure 12. Close the snap button. Figure 12 Insert Therapy Disc Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 38 of 80...

  • Page 39: Removing The Therapy Disc From The Relief Belt Pocket

    Press the middle of the clasp to undo the belt, as shown in Figure 15. Belt Care Hand Wash. Do Not Bleach. Line Dry. Do Not Iron. Figure 15 Undo clasp Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 39 of 80...

  • Page 40: Limb Cuff Instructions For Use

    Placing the device in the limb cuff Insert the device in the limb cuff pocket as shown. Secure the device in the pocket using the snap button. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 40 of 80...
  • Page 41 Remove the limb cuff Removing the device from the limb cuff Undo the snap button. Pinch the device on the top and bottom and pull out of the pocket. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 41 of 80...

  • Page 42: Charger

    Therapy Disc, stimulation level, and participant use. The battery level of the Therapy Disc can be found in the Nalu Remote Control application. The battery level is also indicated when the Therapy Disc is powered on (see Therapy Disc instructions).

  • Page 43: Powering Up The Charger

    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 the correct placement. 2. Verify that the LED status light ring changes from blue to orange (which means charging is in progress) or green (meaning that the battery is fully charged).

  • Page 44: Troubleshooting

    The stimulation amplitude is Increase the amplitude. set too low. The Therapy Disc is The Therapy Disc is not Turn the power ON. Unresponsive powered ON. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 44 of 80...
  • Page 45 Adhesive Causing Skin The adhesive was removed Increase your wear time and remove Breakage too early. the adhesive when it is looser. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 45 of 80...

  • Page 46: Safety And Technical Checks

    Periodic safety checks or 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. Refer to the contact information at the end of this manual.

  • Page 47: Therapy Disc, Charger, And Clip Disposal

    THERAPY DISC, CHARGER, AND CLIP DISPOSAL The Therapy Disc and charger should be returned to your clinician or a Nalu representative. Do not dispose of your Therapy Disc or charger in the garbage. For the single-use adhesive clips, adhere to local disposal requirements / regulations.

  • Page 48: Identification Card

    Your identification card may allow you to bypass security devices. Carry this card with you at all times. If you move, change doctors, or lose your card, contact Nalu for a replacement card. Refer to the contact information at the end of this manual.

  • Page 49: Kit Contents

    Therapy Disc Charger Wall Adapter (US Type A) 43006 Therapy Disc Charger USB Cable 43007 Equipment Bag LBL-000005 Nalu Neurostimulation ID Card MA-000007 Nalu Neurostimulation User Instructions for Use 53002-001 Remote App Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 49 of 80...
  • Page 50 Adhesive Clip Pack (H200 Adhesive) 74007-003 34005-003 Adhesive Clip Pack (H300 Adhesive) 74007-002 34005-002 Adhesive Clip Pack (H100 Adhesive) 74007-004 34005-004 Adhesive Clip Pack HS100 Adhesive) Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 50 of 80...

  • Page 51: Device Specifications

    3” / 76 mm Diameter: 0.6” / 15 mm Thickness: Weight: <100g Description: Cable Material: Polyvinyl Chloride Connector: Micro HDMI Connector 5”/ 1 7 mm Length: Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 51 of 80...
  • Page 52 Cable Material: Polyvinyl Chloride Connector: Micro HDMI Adhesive Clip Pack (H200)– # 34005-001 Description: Clip Material: Polypropylene 3”/ 76 mm Diameter: Description: Adhesive Material: Hydrocolloid Weight: Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 52 of 80...
  • Page 53 Material: Hydrocolloid Material: Hydrocolloid Weight: Weight: Adhesive Clip Pack (S200)– # 34005-004 Description: Clip Material: Polypropylene Diameter: 3”/76 mm Description: Adhesive Material: Silicone Weight: 8 g Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 53 of 80...
  • Page 54 48”/ 1 Length: Weight: 69 g Limb Cuff – # 34009 Description: Cuff Description: Velcro Material: Neoprene Material: Acetal 18”/ 46 cm Length: Weight: 33 g Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 54 of 80...
  • Page 55 5”/ 64 cm Length: Weight: 40 g Therapy Disc Charger – # 43001 Description: Case Material: Acrylonitrile Butadiene Styrene 3”/ 76 mm Diameter: Weight: 67 g Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 55 of 80...

  • Page 56: Radiofrequency (Rf) And Wireless Data Parameters

    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 57: Quality Of Service For Wireless Technology

    (2x), and a receive-to-transmit mode (RX-to-TX) time. Data is resent if not sent successfully. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 57 of 80...

  • Page 58: Troubleshooting For Wireless And Coexistence Issues

    Do not operate other wireless devices (i.e., laptop, tablet, mobile phone, or cordless phone) at the same time NOTE: Wireless communications equipment, such as wireless home network devices, mobile and cordless telephones, and tablets, can affect the device. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 58 of 80...

  • Page 59: Statement Of Fcc Compliance

    This device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment under FCC rules. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 59 of 80...
  • Page 60 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...
  • Page 61 Electromagnetic Immunity 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 Immunity Test IEC 60601 Test Level...
  • Page 62 The Nalu Neurostimulation System is intended for use in an electromagnetic environment in which radiated RF disturbances 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 communications equipment (transmitters) and the System.

  • Page 63: 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 64 15 minutes of continuous scanning in First level controlled mode for Transmit-receive and extremity and head coils (Partial body SAR of the exposed body part of 10 W/kg and Head SAR of 3.2 W/kg). No external components of the Nalu Neurostimulation system are permitted in the MRI system room.
  • Page 65 • 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...
  • Page 66 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 67 Extremity MRI Examinations Patient implanted with Nalu Neurostimulation System Transmit/receive RF 1.5 T or 3 T MR system knee coil Figure 2a Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 67 of 80...
  • Page 68 Patient Implanted with Nalu Neurostimulation System 1.5 T or 3 T MR system Transmit/receive RF foot/ankle coil Figure 2b Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 68 of 80...
  • Page 69 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 70 Pulse Generators (11001-040, 11002-040, 11003-002, 11004-002), 40 cm Lead (12001- 040), and Anchor (13001). Patient has implanted a Nalu IPG laterally pocketed from the vicinity of vertebrae L2 with 40cm leads in epidural space with stimulating contacts in the vicinity of T8-T10 (per Figure 3);...
  • Page 71 Under the scan conditions defined above, the Nalu Neurostimulation System is expected to produce a maximum temperature rise of 6°C after 15 minutes of continuous scanning (i.e., per pulse sequence) when using one of the above types of transmit/receive RF coils at a maximum, whole body averaged SAR of 1.0 W/kg.
  • Page 72 The center of bore is between the ZONE bottom of the skull and bottom of Enforce whole body average SAR restriction of 1.0 W/kg. the buttocks. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 72 of 80...
  • Page 73 Acceptable MRI Scenarios Chart Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J Page 73 of 80...
  • Page 74 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 the Nalu Implantable Pulse Generator. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J...

  • Page 75: Magnetic Resonance Imaging (Mri) Safety Information (Pns)

    Lead Model 12001-040 or 12007-040, Dual 4-Contact Ported Model 11007-002 connected to two 25 cm Nalu Tined Lead Model 12005-025 or two 40 cm Nalu Tined Lead Model 12005-040. Single Ported Model 11003-002 connected to a 40 cm Nalu Lead Model 12001-040 or 12007-040, Single...
  • Page 76 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 77 • 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 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...
  • Page 78 • A patient implanted with a Model 12001-040 40 cm lead(s) connected to a Model 11003-002 or Model 11004-002 Ported IPG; or a Model 12005-025 25 cm tined lead or Model 12005-040 40 cm tined lead connected to a Model 11006-002 4-Contact Ported IPG or a 11007-020 Dual 4-Contact Ported IPG can undergo an MRI examination under the specified conditions.
  • Page 79 • 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 the Nalu Implantable Pulse Generator. • If possible, do not sedate or anesthetize the patient so that the patient can inform the MRI system operator of any unusual sensations or problems associated with the MRI examination.

  • Page 80: 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. Nalu User’s Kit Instructions for Use PN: MA-000007 Rev J...

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