PHYSICIAN IMPLANT MANUAL Senza® Bluetooth® Trial System Effective November 2020 10000891 Rev A
All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, 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 201 Sussex Street, Darling Park, Tower II, Level 20 Sydney, NSW 2000 Australia © Copyright 2020, Nevro Corp. All rights reserved.
CONTENTS 1 EXPLANATION OF SYMBOLS ON THE PRODUCT OR LABELING .......................................................................................... 5 2 INTRODUCTION ................................................................................................................................................................ 8 2.1 ABOUT THIS BOOKLET .............................................................................................................................................................
5.2.1 If Impedances are not within the normal range ....................................................................................................... 28 6 PATIENT IDENTIFICATION CARD ..................................................................................................................................... 30 7 ADDITIONAL INFORMATION .......................................................................................................................................... 31 END ...............
1 EXPLANATION OF SYMBOLS ON THE PRODUCT OR LABELING SYMBOLS DESCRIPTION Serial number Caution Batch number Date of manufacture Manufacturer Expiration date Catalog number Physician only Temperature limit Consult instructions for use Consult electronic instructions for use www.nevro.
SYMBOLS DESCRIPTION Sterilized using ethylene oxide Non-sterile IP22 Degree of ingress protection provided by enclosure Keep dry Do not re-use Do not re-sterilize Do not use if package damaged Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. Magnetic resonance (MR) unsafe Non-ionizing electromagnetic radiation www.nevro.co m Type BF applied part.
SYMBOLS DESCRIPTION Authorized European representative Medical device Unique device identification Refer to Instruction manual/booklet AAA Battery 10000891 REV A 7
2 INTRODUCTION 2.1 About This Booklet This booklet was written for doctors that may prescribe the Nevro® Senza® BLUETOOTH® Spinal Cord Stimulator (SCS) System to help their patients treat chronic pain. For information about indications, contraindications, warnings, precautions, and technical specifications, refer to the Information for Prescribers (P/N 10001045).
3 DEVICE DESCRIPTION The Senza® BLUETOOTH® Spinal Cord System (SCS) Trial System works by delivering electrical energy from a stimulator to an area around the spine. The system is capable of delivering HF10 ® therapy, a therapy that does not produce tingling sensations called paresthesia. It is also capable of providing stimulation that produces paresthesia at some therapy settings.
Battery Compartment Stimulation OFF Button 2 AAA Batteries • Leads: Leads are thin insulated wires that connect to the Trial Stimulator at one end and have small electrodes on the other end placed near the spine. A small amount of electrical energy from the device travels through the leads and to the electrodes near the spine. 3.
Part Number Name Description TLEAD1058-xx Trial Percutaneous Lead Kit 1x8, 5 mm spacing xx = 50, 70, and 90 cm lengths LEAD1058-xx Percutaneous Lead Kit 1x8, 5 mm spacing xx = 50, 70, and 90 cm lengths LEAD3005-xx Surpass Surgical Lead Kit 2x8 paddle xx = 50, 70, and 90 cm lengths LEAD2005-xx Surpass-C Surgical Lead Kit 2x5 paddle xx = 70 and 90 cm lengths LEAD2008-xx Lead Extension Kit 1x8 extension xx = 35, 45, and 60 cm lengths MADP-25B M8 Adaptor Kit Medtronic lead adaptor, 25 cm SA
Competitor Leads Boston Scientific1 Adaptor Required None Compatible Leads SC-2016-xx Infinion™ 16 Lead and Splitter 2x8 Kit2 SC-2016-xxE Infinion 16 Lead and Splitter 2x8 Trial Kit SC-2138-xx Linear™ xxcm 8 Contact Lead SC-2158-xx Linear xxcm 8 Contact Lead SC-2158-xxE Linear xxcm8 Contact Lead SC-2208-xx Linear ST xxcm 8 Contact Lead SC-2218-xx Linear ST xxcm 8 Contact Lead SC-2218-xxE Linear ST xxcm 8 Contact Lead SC-2352-xx Linear 3-4 xxcm 8 Contact Lead SC-2352-xxE Linear 3-4 xxcm
4 INSTRUCTIONS FOR USE Physicians providing SCS therapy with the Senza® Bluetooth® Trial System should be experienced in the diagnosis and treatment of chronic pain and have proper surgical and clinical training. Physicians may elect to perform a trial in one of two ways, temporary or permanent. Nevro devices can be used with either method. • In a Temporary Trial, the lead is implanted in the patient, and the proximal end is externalized and connected to the Trial Stimulator.
Magnet Sensor Symbol Magnet Sensor Pairing Light Pairing Light: Magnet Aligned 3. Hold the magnet over the magnet sensor until the pairing light starts blinking to indicate it is ready to be paired with the Clinician Programmer. Pairing Light Blinking: Ready to be Paired NOTE: Once the Trial Stimulator is woken up with the magnet, there is a 2-minute window for pairing. If nothing pairs with the Trial Stimulator during the 2-minute window, it will go back to sleep.
4. On the Clinician Programmer, scan for stimulators and select the serial number of the Trial Stimulator you wish to pair with. Refer to the Clinician Programmer Manual (P/N 10000906) for additional details. 5. If pairing is successful, the pairing light on the Trial Stimulator will light up solid briefly and then turn off. Once the Trial Stimulator is successfully paired with the Clinician Programmer, it will remain awake. 6.
Remote Control ON / OFF Button Program Selection Button What You Hear What It Means One long beep The Remote Control successfully paired with the Trial Stimulator. Three regular beeps The Remote Control did not find the Trial Stimulator. Make sure the Trial Stimulator Pairing Light is still blinking and try again. Refer to the Troubleshooting section of this manual. Four regular beeps The Remote Control found more than one Trial Stimulator ready for pairing.
4. Insert the needle at an angle of 45° or less (pointing the needle in the direction of the target location) into the posterior ligamentous complex at the desired vertebral level using fluoroscopic guidance. CAUTION: Inserting the lead while the needle is at an angle of greater than 45° may damage the lead or increase the difficulty of lead placement. 5. Remove the needle-stylet from the needle cannula and confirm entry into the epidural space using standard methods such as loss of resistance.
CAUTION: Make sure the lead door is unlocked (orange markings below door are visible) before inserting the lead to prevent damage to the lead. 3. Insert the first lead into Lead Port 1 until the most proximal contact of the lead is aligned with the notch on the Trial Stimulator lead door. Proximal End Contact Notch 4. Press Lead Door 1 on the Trial Stimulator until there is an audible click (orange markings below the door are no longer visible). Gently tug on the lead to verify the door is locked.
CAUTION: Always turn the Trial Stimulator OFF using the Programmer or Remote Control before connecting or disconnecting the leads. 9. At this point, you may opt to continue with either a Temporary Trial (continue to 4.4), or a Permanent Trial (continue from 4.5). 4.4 Temporary Trial 4.4.1 Preparing for Temporary Trial 1. Using minimal force, carefully withdraw the insertion needle from the patient while holding the percutaneous lead. 2.
CAUTION: If needed, it is recommended that bipolar electrocautery be 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. 4.5.2 Instructions Specific to Silicone Anchors For silicone anchors, at least one suture is needed (two are recommended) to tie the lead anchor to the lead, and another suture is needed to attach the lead anchor and lead to the patient’s tissue. 1.
NOTE: If the lead does not fully insert into the lead extension’s connector, check whether the setscrew is impeding the progress of the lead. If it is, use the torque wrench to loosen the setscrew by turning it counterclockwise and then re-insert the lead. Ensure that the setscrew is not removed from the connector. 2. Conduct impedance testing. Refer to the Clinician Programmer Manual (P/N 10000906) for detailed instructions.
NOTE: Instead 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). 4.5.6 Closing the Incision Sites 1. 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. 2. Gently pull on the lead extension from the exit site to remove excess slack. 3.
Proximal End Contact Notch 7. Press Lead Door 1 on the Trial Stimulator until there is an audible click (orange markings below the door are no longer visible). Gently tug on the lead to verify the door is locked. Door Locked (No Orange Visible) 8. Repeat the three (3) preceding steps for the second lead and Trial Stimulator Lead Port 2. When two leads are used, the leads may be marked using a sterile surgical marker to distinguish between the two leads. 4.
1. To use the Pouch, insert the Trial Stimulator with leads into the Pouch by lifting the pouch flap and shimmying the Trial Stimulator into the Pouch. 2. Pull leads through lead openings 1 and 2 of the pouch after sliding the Trial Stimulator into the pouch. Make sure that the leads at the incision site has not shifted as a result. 3. Conduct impedance testing. Refer to the Clinician Programmer Manual (P/N 10000906) for detailed instructions.
2. If the Pouch was used to adhere the Trial Stimulator to the patient, carefully lift the pouch flap to open the Pouch and pull the Trial Stimulator out. Otherwise, carefully lift the dressing used to secure the Trial Stimulator to the patient. 3. Slide the battery door off the Trial Stimulator and remove the old battery. CAUTION: Do not remove the battery in the Trial Stimulator unless the battery is being replaced.
8. Close the Pouch by pressing the adhesive strip to the Pouch. Add additional tape if necessary. 9. Turn the Trial Stimulator ON using the Remote Control or Clinician Programmer. 4.8.3 Disconnecting the Trial Stimulator 1. Turn the Trial Stimulator OFF using the Remote Control or Clinician Programmer. CAUTION: Always turn the Trial Stimulator OFF using the Programmer or Remote Control before connecting or disconnecting the leads. 2.
5 TROUBLESHOOTING 5.1 Troubleshooting Pairing 5.1.1 If the Clinician Programmer cannot pair with the Trial Stimulator • Make sure the Trial Stimulator is awake and ready for pairing. • Prepare the Trial Stimulator for pairing by holding the magnet over the magnet sensor on the Trial Stimulator. The Pairing LED should light up solid blue once the magnet is properly aligned with the magnet sensor.
What You Hear Three regular beeps • What You See All lights are off The Remote Control did not find the Trial Stimulator. If the Remote Control beeps four times when it is done searching, the Remote Control found more than one Trial Stimulator ready for pairing. The Remote Control can only pair when only one Trial Stimulator is found. Wait 2 minutes and try again.
• Make sure the lead doors on the Trial Stimulator are locked by pressing down on the doors until there is an audible click and the orange markings below the door are no longer visible. Gently tug on the leads to verify the doors are locked.
6 PATIENT IDENTIFICATION CARD Doctors should provide patients with a temporary Patient Identification (ID) Card during the trial phase. Patients should always carry their Patient ID Card with them. The card identifies someone as a device patient, and it may be important for the patient in a medical emergency. If a patient ever needs to go through a security checkpoint, they should show their Patient ID Card. Patients should let their doctor know if they move or their personal information changes.
7 ADDITIONAL INFORMATION Refer to the Clinical Summary (P/N 12057) for additional information regarding clinical studies of the Senza System and safety and effectiveness data. Refer to the Information for Prescribers (P/N 10001045) for indications, contraindications, warnings, warnings about other medical treatments, precautions, adverse events, technical specifications, and security features and declarations.
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NEVRO CORP. All questions or concerns about Nevro Corp. products, including any serious incident that has occurred in relation to the device, 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.
