Physician Implant Manual Senza® Senza II® ONLY
NEVRO CORP. All questions or concerns about Nevro Corp. products should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 info@nevro.com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Australia Level 20, Tower II, Darling Park 201 Sussex Street, Sydney, NSW 2000 Australia © Copyright 2018, Nevro Corp. All rights reserved.
Explanation of symbols. Refer to the product for symbols that apply. Symbols Description SN Serial number LOT Batch code Date of Manufacture Manufacturer Caution Catalog number XX C XX F XX C XXX F STERILE EO Temperature limitation (storage) Sterilized using ethylene oxide Use by Do not use if package is damaged Do not reuse Do not re-sterilize Keep dry ONLY Prescription only Consult Electronic Instructions for Use www.nevro.
Type BF Applied Part Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations.
Table of Contents 1. Device Description ......................................................................................................................... 6 2. Indications for Use ......................................................................................................................... 8 3. Contraindications ........................................................................................................................... 8 4. Warnings ..........................................
1. Device Description The Senza® and Senza II® Spinal Cord Stimulation (SCS) Systems are neuromodulation devices designed to deliver electrical stimulation for the treatment of chronic intractable pain of the trunk and/or limbs. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads and a rechargeable, implantable pulse generator (IPG).
The Percutaneous Lead has an isodiametric body made out of Pellethane 55D, which carries eight low impedance cables. The proximal connector end has eight (8) individual contacts which interface with the Nevro IPG and Lead Extensions. The proximal end of the Surgical Lead has two legs each with 8 contacts. The proximal end of the Surgical Lead is identical to the proximal end of the Percutaneous Lead. The distal end of the lead is molded out of Silicone material and has 16 distal electrodes.
2. Indications for Use The Senza® and Senza II® neuromodulation systems are intended to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: • Failed back surgery syndrome • Intractable low back pain • Upper back pain • Leg pain • Upper limb and neck pain 3. Contraindications The Senza and Senza II systems should not be used for those patients who: • Are poor surgical candidates.
Diathermy Therapy – Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy on patients implanted with a neuromodulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. The neuromodulation system, whether it is turned on or off, may be damaged.
If a patient is required to undergo lithotripsy, high-output ultrasound, electrocautery, external defibrillation, radiation therapy, or ultrasonic scanning, follow these precautions. • • • • • • Turn off the IPG before the procedure. Use the equipment as far away from the IPG as possible. Keep fields, such as current, radiation, or high-output ultrasonic beams, away from the IPG. Equipment should be set to the lowest energy setting possible.
Electrostatic Discharge (ESD) is a common source of electromagnetic interference that can occur when a person or object accumulates a static charge. ESD is made worse by low humidity and synthetic materials. • If the battery terminals of the Trial Stimulator are exposed to ESD, the device may reset and stop stimulation. Stimulation can be restarted by following the instructions in the “How to Turn ON Stimulation” section of the Patient Manual.
5. Precautions Patients Who Are Poor Surgical Candidates – Do not implant an SCS system if a patient is considered a poor surgical candidate. Implanting an SCS system has risks similar to surgical procedures of the spine, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis. Pregnancy – The safety and effectiveness of spinal cord stimulation has not been established for use during pregnancy or nursing.
Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water or other rough handling, can permanently damage the components and accessories. Do not plug the charger into a power source near water. Handling the Leads and Lead Extensions - Follow these guidelines when handling the Leads or Lead Extensions: • Lead and lead extension should be handled with care at all times.
incision is not sufficiently healed. The charger and the charging belt are not sterile and should not be in contact with the incision. Operating Temperature – The operating temperature range for the Patient Remote Control is 10 to 40 °C (50 to 104 °F). The operating temperature range for the Trial Stimulator is 10 to 38 °C (50 to 100 °F). While the Charger is plugged into the wall and charging itself, the operating temperature range for the Charging System is 10 to 40 °C (50 to 104 °F).
• Do not change or modify any component of the Senza or Senza II Spinal Cord Stimulation systems, unless expressly approved by Nevro Corp. FCC Statements: Programmer Wand Programmer Wand FCC ID: XKYWAND1000, XKYWAND1001 Note: • This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment.
• • Other undesirable sensation such as tingling or prickling Weakness, clumsiness or numbness Implanted Device Components • Tissue reaction or allergy to implanted materials • Persistent pain at implant site (lead or IPG) • Failure of device components or the battery including lead breakage or movement (migration), hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches • Failure or malfunction resulting in ineffective pain control or other undesirable ch
7. Technical Specifications a. System Specifications Parameter Range Frequency 2 – 10,000 Hz Pulse Width 20μsec – 1msec Amplitude 0 – 15mA b. Charger Specifications The following table contains technical specifications for the Charger. AC input for the charger: Parameter Specification Frequency 50 to 60 Hz Voltage 100 to 240 VAC Input Current 0.2 A max Additional technical information, including the Guidance and Manufacturer’s Declarations on electromagnetic emissions and immunity, is available.
f. Telemetry Information The Senza and Senza II systems use a wireless communication system in the MedRadio frequency band (402-405 MHz). The wireless communication system implements Frequency Shift Keying (FSK) modulation. The bandwidth of each of the 8 frequency channels does not exceed 300 kHz, and the Transmitter Effective Isotropic Radiated Power (EIRP) does not exceed -16 dBm (25 µW). Refer to the Patient Manual for more information on optimizing communication.
Guidance and Manufacturer’s Declaration - electromagnetic immunity The Senza and Senza II Systems are intended for use in the electromagnetic environment specified below. The customer or user of the Senza/Senza II System should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance Level Electromagnetic environment guidance Level Electrostatic ±2/4/8/15 kV Air ±2/4/8/15 kV Air Floors should be wood, concrete or ceramic discharge (ESD) ±8 kV Contact ±8 kV Contact tile.
Guidance and Manufacturer’s Declaration - electromagnetic immunity The Senza and Senza II Systems are intended for use in the electromagnetic environment specified below. The customer or user of the Senza/Senza II System should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the Senza/Senza II System The Senza and Senza II Systems are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
9. Instructions for Use The physicians providing SCS therapy with the Senza and Senza II systems should be experienced in the diagnosis and treatment of chronic pain and have proper surgical and clinical training. See sections 10 and 11 below on details for instructions for use. 10. Guidelines for Trial-phase Implantation This section details the recommended procedures for trial-phase implantation of lead(s). a. Temporary vs.
o Turn off the Trial Stimulator before taking out the batteries. o The Trial Stimulator’s battery compartment must remain closed unless the batteries are actively being replaced. o The M8 Adaptor (MADP-25B) can be used to connect specific Medtronic leads to the Nevro Trial Stimulator/IPG. The S8 Adaptor (SADP-25B) can be used to connect specific St. Jude Medical leads to the Nevro Trial Stimulator/IPG. For a list of compatible leads, please consult the M8 Adaptor/S8 Adaptor Instructions for Use.
• • • • Prior to inserting the lead into the needle, ensure that the stylet is fully inserted and extended to the tip of the lead to ensure optimal steering of the lead. With the stylet in the lead, slowly advance the lead into the epidural space. Advance the lead to the appropriate vertebral level using fluoroscopic guidance. Rotate the stylet as necessary to steer the lead. NOTE: o Needles not provided by Nevro Corp. may damage Nevro leads.
o Do not pull on the OR cable while it is connected to the placed lead. f. Preparing for Temporary Trial • Using minimal force, carefully withdraw the insertion needle from the patient while holding the percutaneous lead. • Using minimal force, carefully withdraw the stylet while holding the percutaneous lead. • After removing the needle and the stylet, it is recommended that you confirm the location of the lead using fluoroscopy. • Secure the lead to the skin using sterile tape or suturing to the skin.
o Do not use a hemostat on the lead body. This may damage the lead insulation. o If needed, it is recommended that bipolar electrocautery is used for hemostasis around the epidural needles. Energy from monopolar cauterization could conduct down the needle to the epidural space and damage the neural structures. o If the lead does not fully insert into the active anchor, loosen the anchor by turning the torque wrench counter-clockwise and then re-insert the lead.
• • Make sure that the lead location has not changed. NOTE: In place of the tunneling tool, the following Codman Disposable Catheter Passers may be used using the standard technique: REF 82-1515 (36cm); REF 82-1516 (55cm); REF 82-1517 (65cm). j. Closing the Incision Sites • At the lead insertion site, use blunt dissection to create a pocket large enough to place excess lead. Coil excess lead into small loops and place them in the pocket.
• o With consideration for patient comfort and infection control, identify a desired IPG implant site away from the exit site for the lead extension used for the trial. o Anesthetize the site for the IPG pocket. o Use the IPG template to estimate the size of the pocket. Mark the IPG implant site and make an incision that would be adequate to insert the IPG. o Create a subcutaneous pocket using blunt dissection. The pocket should be no larger than the IPG and no deeper than a depth of 2 cm from the skin.
• • Prepare the IPG implant site and tunnel the lead to the IPG site by following the instructions below: o With consideration for patient comfort and infection control, identify a desired IPG implant site away from the exit site for the lead extension used for the trial. o Anesthetize the site for the IPG pocket o Mark the IPG implant site and make an incision equal to the IPG’s width. o Create a subcutaneous pocket using blunt dissection.
• • • • • • • • • 10186-ENG Rev P Place the lead(s) or lead extension(s) fully into the header port and perform impedance check. NOTE: o When using two leads, connect the left lead or lead extension to IPG port 1L. Then, connect the right lead or lead extension to IPG port 2R. o When using one lead, start by placing the port plug in the 2R port of the IPG and tighten the setscrew. Then insert the lead into IPG port 1L.
e. IPG Explant or Replacement • Turn off the IPG. • Surgically open the IPG pocket and withdraw the device. • It is recommended that electrocautery not be used until the IPG is removed from the patient and the leads or extensions disconnected from the IPG. If the use of electrocautery is necessary while the IPG is still implanted, use bipolar electrocautery. Do not use monopolar electrocautery. • Unscrew the connector setscrews to release and disconnect the leads or extensions.
NEVRO CORP. All questions or concerns about Nevro Corp. products should be forwarded to: Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA Tel: +1.650.251.0005 Fax: +1.650.251.9415 Email: info@nevro.
