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Resources - Nevro HFX Remote Control Patients
User Guide for nevro models including: PTRC3000, PTRC2500, PTRC2300, PTRC1000, CHGR2500, CHGR1000, PTRC3000 HFX Therapy Trial Device, PTRC3000, HFX Therapy Trial Device, Trial Device, Device
Resources - Nevro HFX Remote Control Patients
HFX Therapy Accessory Guides 2024 S004118 F8C011024DV v6 - English UK
File Info : application/pdf, 16 Pages, 5.65MB
DocumentDocumentHFXTM Accessory Guides How to use the Trial Device How to use the Remote Control 12345 (PTRC3000/PTRC2500 - 5 Program Remote) How to use the Remote Control (PTRC2300 - 3 Program Remote) How to use the Remote Control (PTRC1000) How to use the Charger (CHGR2500) How to use the Charger (CHGR1000) How to use the Trial Device For Patients in the Trial Phase You will be using your Remote Control (PTRC3000) to make all stimulation changes during your trial. 1 1. Remote Control ON/OFF Button 2. Stimulation OFF Button 3. Battery Level Indicator (Charge Level of Trial Device) 4. Stimulation Level Indicator 5. Stimulation Start/Increase Button 6. Stimulation Decrease Button 7. Program Indicator 8. Program Selection Button 2 3 4 5 6 7 12345 8 Trial Device EC REP MDSS GMBH | Schiffgraben 41 D-30175 Hannover, Germay Ne Re Ph Your Trial Device Guide During the trial period, please keep your Remote Control within close distance to your Trial Device, as the two will communicate and the Remote Control will beep repeatedly if there is an open lead. · Your Trial Device delivers stimulation to the leads. · You will make all stimulation changes using your Remote Control. · Be sure to keep the Trial Device dry. · Avoid interacting directly with the Trial Device (e.g. touching or applying pressure) as these activities could cause it to come loose from your body. · Check the Stimulation ON Indicator Light on your Remote Control two times per day to confirm stimulation is on. Turning the Remote Control ON Press and hold side button until you hear a long beep. · You may need to press for up to 5 seconds. · If the Remote Control syncs with the Trial Device, at least one LED light on the Remote Control will light up. · If the Remote Control cannot sync with the Trial Device, you will hear 3 beeps and the lights on the Remote Control will turn OFF. · Repeat these steps until you have a link with the Trial Device. Moving the Remote Control closer to the Trial Device will help. · Other buttons on the Remote Control will respond only when the Remote Control is ON and linked to an Trial Device. Turning the Remote Control OFF Press side button to turn off the Remote Control. · Stimulation continues even when the Remote Control is OFF. · Remote Control will turn off by itself after 2 minutes of inactivity. 2 Turning stimulation ON and changing program To turn stimulation ON, make sure the Remote Control is ON. · Stimulation is ON unless it has been turned OFF. · If Stimulation Level Indicator is not illuminated, stimulation is OFF. Press once to turn stimulation ON to predetermined level. · When stimulation is turned ON (after it was turned OFF), the trial device will be on the starting level for the last active program used. To change the program, press the Program Selection Button . · Press repeatedly until the light is at the desired program number. · Once desired program is selected, do not press any buttons until the light stops blinking. The Remote Control will sound 1 beep, confirming the new program setting. Verify that the light above the desired program number is steadily illuminated. · If the Remote Control beeps 3 times and the Program Indicator goes back to the previous program, then the program was not successfully changed. Place the Remote Control closer to the Trial Device and repeat previous steps. Changing stimulation level The remote should be turned ON before adjusting the stimulation level. Press to increase stimulation level. Press to decrease stimulation level. · For each or , 1 beep will sound. · The level of stimulation can be seen in the Stimulation Level Indicator. · When stimulation level for selected program is at the maximum or minimum level and you try to go one level up or down, 2 beeps sound, indicating that you are at the currently programmed limit. Turning stimulation OFF Once the Remote Control is ON, press the under the battery door to turn stimulation OFF. · The lights on the Stimulation Level Indicator will be OFF when stimulation is OFF. · The button only turns stimulation OFF. It does not turn stimulation ON. Replacing the batteries Replace the batteries in the Remote Control if any of the following situations arise: · The Remote Control beeps 6 times when turned on. · The Remote Control will not turn on. The Remote Control uses 2 AAA batteries, alkaline only. DO NOT USE lithium or rechargeable batteries. When the Battery Level Indicator shows 2 dots or fewer, the batteries in the Trial Device are running low. If the Remote Control beeps 10 times when you turn it ON, the Trial Device battery is completely empty, and the stimulation has been turned OFF. Contact your doctor to schedule an appointment to change your battery. 3 Troubleshooting What You Hear Continuous beeping for 60 seconds What You See All the Stimulation Level Indicator lights are blinking What It Means There may be a loose connection between a lead and the Trial Device. What To Do Dismiss the beeping and blinking by pressing and holding the ON / OFF button for up to five seconds. Contact your doctor. Continuous beeping for 60 seconds All the Battery Level lights are blinking The Trial Device battery is low or completely empty. Dismiss the beeping by pressing and holding the ON / OFF button for up to five seconds. The battery lights will continue to flash. Contact your doctor. 4 How to use the Remote Control (PTRC3000/PTRC2500) For Patients in the Implant Phase 1. Remote Control ON/OFF Button 1 2. Stimulation OFF Button 3. Battery Level Indicator (Charge Level of Implant) 4. Stimulation Level Indicator Ladder lights 5. Stimulation Start/Increase Button 6. Stimulation Decrease Button 7. Program Indicator 8. Program Selection Button 2 3 4 5 6 7 12345 8 EC REP MDSS GMBH | Schiffgraben 41 D-30175 Hannover, Germay Ne Re Ph Tips Replace the batteries in the Remote Control if any of the following situations arise: · The Remote Control beeps 6 times when turned on. · The Remote Control will not turn on. · It has been 3 months since the last battery change. To achieve optimal relief, make sure you work closely with your HFX Care Team to identify which programs work best for you. They will provide guidance on how and when to use the Remote Control. The Remote Control uses 2 AAA batteries, alkaline only. DO NOT USE lithium or rechargeable batteries. When the Battery Level Indicator shows 2 dots or less, your Implant battery needs to be recharged using the Charger. Video instructions are available at www.NevroHFX.com/en/resources/remote-control/. Turning the Remote Control ON Press and hold side button until you hear a long beep. · You may need to press for up to 5 seconds. · If the Remote Control syncs with the Implant, at least one LED light on the Remote Control will light up. · If the Remote Control cannot sync with the Implant, you will hear 3 beeps and the lights on the Remote Control will turn OFF. · Repeat these steps until you have a link with the Implant. Moving the Remote Control closer to the Implant will help. · Other buttons on the Remote Control will respond only when the Remote Control is ON and linked to an Implant. Turning Remote Control OFF Press side button to turn off the Remote Control. · Stimulation continues even when the Remote Control is OFF. · Remote Control will turn off by itself after 2 minutes of inactivity. 5 Turning stimulation ON and changing program To turn stimulation ON, make sure the Remote Control is ON. · Stimulation is ON unless it has been turned OFF. · If Stimulation Level Indicator is not illuminated, stimulation is OFF. Press once to turn stimulation ON to predetermined level. · When stimulation is turned ON (after it was turned OFF), the Implant will be on the starting level for the last active program used. To change the program, press the Program Selection Button . · Press repeatedly until the light is at the desired program number. · Once desired program is selected, do not press any buttons until the light stops blinking. The Remote Control will sound 1 beep, confirming the new program setting. Verify that the light above the desired program number is steadily illuminated. · If the Remote Control beeps 3 times and the Program Indicator goes back to the previous program, then the program was not successfully changed. Place the Remote Control closer to the Implant and repeat previous steps. Changing stimulation level The remote should be turned ON before adjusting the stimulation level. Press to increase stimulation level. Press to decrease stimulation level. · For each or , 1 beep will sound. · The level of stimulation can be seen in the Stimulation Level Indicator. · When stimulation level for selected program is at the maximum or minimum level AND you try to go one level up or down, 2 beeps sound, indicating that you are at the currently programmed limit. How to change groups Example: Remote Control showing Group 1 - Program 1 Please contact your HFX Care Team before accessing these settings in your Remote Control. · To enter Group Change mode, press and hold the for at least 3 seconds. You will then see one blinking light above the that indicates what Group number you are currently on. Use the or to move to desired Group number. · To confirm the change to your new group, press and hold the again for at least 3 seconds. You will hear one long beep that confirms the change has been made. The remote will then automatically exit Group Change mode. If you do not confirm the Group number change within 60 seconds, changes will not be saved. · Your remote will show what Group number you are currently on any time you change programs. To activate a program change, press the once. You will then see one number level illuminated indicating your current group number. Press the a second time to move to the next program. Turning stimulation OFF Group (1-7) 12345 Program (1-5) (G1 - P1) Once the Remote Control is ON, press the under the battery door to turn stimulation OFF. · The lights on the Stimulation Level Indicator will be OFF when stimulation is OFF. · The button only turns stimulation OFF. It does not turn stimulation ON. 6 How to use the Remote Control (PTRC2300) For Patients in the Implant Phase 1. Remote Control ON/OFF Button 1 3 2. Stimulation OFF Button 3. Battery Level Indicator (Charge Level of Implant) 4 4. Stimulation Level Indicator Ladder lights 5 5. Stimulation Start/Increase Button 6. Stimulation Decrease Button 6 7. Program Indicator 7 8. Program Selection Button 8 2 EC REP MDSS GMBH | Schiffgraben 41 D-30175 Hannover, Germay Ne Re Ph Tips Replace the batteries in the Remote Control if any of the following situations arise: · The Remote Control beeps 6 times when turned on. · The Remote Control will not turn on. · It has been 3 months since the last battery change. To achieve optimal relief, make sure you work closely with your HFX Care Team to identify which programs work best for you. They will provide guidance on how and when to use the Remote Control. The Remote Control uses 2 AAA batteries, alkaline only. DO NOT USE lithium or rechargeable batteries. When the Battery Level Indicator shows 2 dots or less, your Implant battery needs to be recharged using the Charger. Video instructions are available at www.NevroHFX.com/en/resources/remote-control/. Turning the Remote Control ON Press and hold side button until you hear a long beep. · You may need to press for up to 5 seconds. · If the Remote Control syncs with the Implant, at least one LED light on the Remote Control will light up. · If the Remote Control cannot sync with the Implant, you will hear 3 beeps and the lights on the Remote Control will turn OFF. · Repeat these steps until you have a link with the Implant. Moving the Remote Control closer to the Implant will help. · Other buttons on the Remote Control will respond only when the Remote Control is ON and linked to an Implant. 7 Turning Remote Control OFF Press side button to turn off the Remote Control. · Stimulation continues even when the Remote Control is OFF. · Remote Control will turn off by itself after 2 minutes of inactivity. Turning stimulation ON and changing program To turn stimulation ON, make sure the Remote Control is ON. · Stimulation is ON unless it has been turned OFF. · If Stimulation Level Indicator is not illuminated, stimulation is OFF. Press once to turn stimulation ON to predetermined level. · When stimulation is turned ON (after it was turned OFF), the Implant will be on the starting level for the last active program used. To change the program, press the Program Selection Button . · Press repeatedly until the light is at the desired program number. · Once desired program is selected, do not press any buttons until the light stops blinking. The Remote Control will sound 1 beep, confirming the new program setting. Verify that the light above the desired program number is steadily illuminated. · If the Remote Control beeps 3 times and the Program Indicator goes back to the previous program, then the program was not successfully changed. Place the Remote Control closer to the Implant and repeat previous steps. Changing stimulation level The remote should be turned ON before adjusting the stimulation level. Press to increase stimulation level. Press to decrease stimulation level. · For each or , 1 beep will sound. · The level of stimulation can be seen in the Stimulation Level Indicator. · When stimulation level for selected program is at the maximum or minimum level AND you try to go one level up or down, 2 beeps sound, indicating that you are at the currently programmed limit. Turning stimulation OFF Once the Remote Control is ON, press the under the battery door to turn stimulation OFF. · The lights on the Stimulation Level Indicator will be OFF when stimulation is OFF. · The button only turns stimulation OFF. It does not turn stimulation ON. 8 How to use the Remote Control (PTRC1000) For Patients in the Implant Phase 1 5 1. Remote Control ON/OFF Button 2. Stimulation Level Indicator 2 3. Program Indicator 6 4. Program Selection Button 7 5. Stimulation OFF Button 3 6. Stimulation Start/Increase Button 4 7. Stimulation Decrease Button 8 8. Battery Level Indicator (Charger level of Trial Device or Implant) Tips Guidance on using your Remote Control will be provided by your HFX Care Team. You may not need to make any programming changes during the temporary trial. To achieve optimal relief, make sure you work closely with your HFX Care Team. Replace the batteries in the Remote Control if any of the following situations arise: · The Remote Control beeps 6 times when turned on. · The Remote Control will not turn on. The Remote Control uses 2 AA batteries, alkaline only. DO NOT USE lithium or rechargeable batteries. When the Battery Level Indicator shows 2 bars or fewer, the batteries in the Trial Device need to be replaced. See Trial Device Guide. Turning the Remote Control ON Press and hold until you see lights turn on and hear a beep. · You may need to press for up to 5 seconds. · If the Remote Control syncs with the Trial Device or Implant, your Program Indicator (1, 2, or 3) will light up. You'll also see lights on the Stimulation Level Indicator indicating the stimulation is ON. · If the Remote Control cannot sync with the Trial Device or Implant, you will hear 3 beeps and the lights on the Remote Control will turn OFF. · Repeat these until you have a link with the Trial Device or Implant. Moving the Remote Control closer to the Trial Device or Implant will help. · Other buttons on the Remote Control will respond only when the Remote Control is ON and linked to the Trial Device or Implant. 9 Turning Remote Control OFF Press to turn OFF the Remote Control. · Stimulation continues even when the Remote Control is OFF. · DO NOT press to turn OFF the Remote Control. turns stimulation OFF. · Remote Control will turn off by itself after 2 minutes of inactivity. Turning stimulation OFF Once the Remote Control is ON, press to turn stimulation OFF. · The lights on the Stimulation Level Indicator will be OFF when stimulation is OFF. · This button only turns stimulation OFF. It does not turn stimulation ON. Turning stimulation ON and changing program To turn stimulation ON, press . The Remote Control must be ON. · Stimulation is ON unless it has been turned OFF. · When stimulation is turned ON (after it was turned OFF), the Trial Device or Implant will be on the starting level for the last active program used. To change the program, press . · Program Indicator light will start blinking. · Press repeatedly until the light is at the desired program number. · Once desired program is selected, do not press any buttons until the light stops blinking. The Remote Control will sound one long beep, confirming the new program setting. Verify that the light above the desired program number is steadily illuminated. · If the Remote Control beeps 3 times and the Program Indicator goes back to the previous program, then the program was not successfully changed. Place the Remote Control closer to the Trial Device or Implant and repeat previous steps. Changing stimulation level The remote should be turned ON before adjusting the stimulation level. Press Press to increase stimulation level. to decrease stimulation level. · For each or , 1 beep will sound. · The level of stimulation can be seen in the Stimulation Level Indicator. · When stimulation level for selected program is at the maximum or minimum level AND you try to go one level up or down, 2 beeps sound, indicating that you are at the currently programmed limit. 10 How to use the Charger (CHGR2500) For Patients in the Implant Phase 1 1. Charging Coil 2. Power Adapter Port 3. Charger Battery Level Indicator 4. Charge Start Button 5. Antenna Strength Indicator 2 6. Implant Battery Level Indicator 4 6 5 3 Tips Charging times may vary for each session, depending on factors such as recharging frequency and stimulation settings. If the Charging Coil has an insufficient link (shown by the Antenna Strength Indicator circle lights), reposition the Charging Coil slowly and wait 3 seconds. The Antenna Strength Indicator circle lights may take up to 3 seconds to update the new Charging Coil position. Repeat as necessary. If charging time is shorter than expected, your Implant may have been turned OFF. Make sure your Implant is turned ON with the Remote Control. You will know stimulation is ON if you see the lights illuminated above the arrow. Important reminders You can still get stimulation from your Implant even during charging. Do not charge the Implant while the Charger is plugged into the wall. Always remove the Power Adapter before pressing the Charge Start Button . Unplug the Power Adapter from the wall each time you use the Charger on your Implant. Once you are finished charging, plug the Charger back into the Power Adapter and then the Power Adapter into the wall so the Charger will be ready for your next recharging session. Recharge the Implant regularly to develop an easy-to-remember routine. While charging, the implant site may become warm. If pain or discomfort is felt, stop charging and contact your doctor or Nevro HFX Care Team. Use the Remote Control to verify that the stimulation is ON. If charging times dramatically increase, please notify your doctor or Nevro HFX Care Team. Video instructions are available at www.NevroHFX.com/en/resources/remote-control/. 11 Charging preparation Place the center of the circular Charging Coil over the top of your Implant. · The figure below shows that the top of the Implant (in yellow box) is at the center of the Charging Coil. Initiate charging Press the Charge Start Button to turn on the Charger. The light on the side of the device (Charger Battery Level Indicator) will illuminate to confirm the Charger is on. The Charger will start to beep and look for the Implant. 1. Beeping continues until the Charger links with the Implant. 2. If 10 seconds pass without a link, the Charger will sound one long beep and shut off. Reposition the Charging Coil and press the Charge Start Button again. 3. When at least one lighted circle appears on the Antenna Strength Indicator, a link has been made. More circles mean a better link, and make it less likely that charging will be interrupted by movements. If only the middle dot is illuminated, this indicates poor connection and the Implant and the Charger will not link. 4. When the Charger is in the correct position, the IPG Battery Level Indicator will light up. If the link is not made, is insufficient, or is lost, reposition the blue Charging Coil slowly and repeat the above steps. Charging Charging is in progress when you see the IPG Battery Level Indicator and the circles on the Antenna Strength Indicator are lit. As charging progresses, the number of lit dots on the IPG Battery Level Indicator will increase. · If the link is lost, the Charger will beep. Reposition the Charging Coil and repeat steps under the "Initiate Charging" section. 12 Complete charging When charging is complete, one long beep will sound and the Charger will turn itself off automatically. There is no off button on the Charger. Check the Implant Battery Level to make sure the battery is fully charged (four dots). Use the Remote Control to check that the Implant is turned ON. Plug the Charger into the wall socket to ensure the Charger will be ready for the next charging session. · To plug the Charger into the wall socket, connect the Power Adapter into the Charger's Power Adapter Port, then plug the Power Adapter into the wall socket. The orange light indicates the Charger is being recharged. Recharging is complete when the orange light turns off. Using the charger belt Once you know where to place the Charging Coil to achieve a strong link with the Implant, use the Charger Belt to secure the Charging Coil's location on your body before charging. 1. Place the blue Charging Coil in the pouch on the Charger Belt and securely attach belt around the waist. Use the hook and loop near the pouch to secure the cable of the Charging Coil. 2. Initiate charging and move the Charging Coil until it links with the Implant. 3. If you want to be mobile during charging, insert the Charger into the holster, then clip the holster to your belt or pants. 13 How to use the Charger (CHGR1000) For Patients in the Implant Phase 1. Charging Coil 2. Charger Battery Level Indicator 1 3. Antenna Strength Indicator 4. Stimulation OFF Button 5. Charge Start Button 6. Power Adapter Port 7. Implant Battery Level Indicator 3 4 2 5 67 Tips Do not press unless you want to turn OFF the stimluation. To turn the stimulation ON, use your Remote Control. Charging times may vary for each session, depending on factors such as recharging frequency and stimulation settings. If the Charging Coil has an insufficient link (shown by the Antenna Strength Indicator), reposition the Charging Coil slowly and wait 3 seconds. The Antenna Strength Indicator may take up to 3 seconds to update the new Charging Coil position. Repeat as necessary. If charging time is shorter than expected, your Implant may have been turned OFF. Make sure your Implant is turned ON with the Remote Control. Important reminders Do not charge the Implant while the Charger is plugged into the wall. Always remove the Power Adapter before pressing the Charge Start Button. Recharge the Implant regularly to develop an easy-to-remember routine. While charging, the implant site may become warm. If pain or discomfort is felt, stop charging and contact your doctor or Nevro HFX Care Team. After recharging the Implant, plug the Charger back into the wall so the Charger will be ready for your next recharging session. Use the Remote Control after charging to verify that the stimulation is ON. If charging times dramatically increase, please notify your Nevro HFX Care Team. Video instructions are available at www.NevroHFX.com/en/resources/remote-control/. 14 Charging preparation Place the center of the circular Charging Coil over the top of your Implant. · Figure 1 shows that the top of the Implant (in yellow box) is at the center of the Charging Coil. · Figure 2 shows an Implant just below the beltline. Your Implant may be in a different location, such as on your front side, in the abdomen (not shown). Figure 1 Figure 2 Initiate charging Press and hold until beeping starts, then release. 1. Beeping and blinking of green lights continues until the Charger links with the Implant. 2. If 10 to 12 seconds pass without a link, the Charger will sound one long beep and shut off. Reposition the Charging Coil and press hold again. 3. When lights appear on the Antenna Strength Indicator, a link has been made. More lights mean a better link, and make it less likely that charging will be interrupted by movements. 4. If the link is insufficient or lost, the Antenna Strength Indicator will show only the small orange bar and beep intermittently. If the link is not made, is insufficient, or is lost, reposition the blue Charging Coil slowly and repeat Steps 1 and 2. Charging Charging is in progress when you see lights blinking on both the Charger Battery Level Indicator and the Implant Battery Level Indicator. As charging progresses, the number of lights on the Charger Battery Level Indicator will decrease and the number of lights on the Implant Battery Level Indicator will increase. · If the link is lost, the Charger will beep. Reposition the Charging Coil and repeat Steps 1 and 2. 15 Complete charging When charging is complete, one long beep will sound and the lights on the Charger will turn OFF. Check the Implant Battery Level to make sure the battery is fully charged. Use the Remote Control to check that the Implant is turned ON. Plug the Charger into the wall socket to ensure the Charger will be ready for the next charging session. · To plug the Charger into the wall socket, connect the Power Adapter into the Charger's Power Adapter Port, then plug the Power Adapter into the wall socket. · It's okay to continuously charge the Charger. The battery will not be damaged. Using the charger belt Once you know where to place the Charging Coil to achieve a strong link with the Implant, use the Charger Belt to secure the Charging Coil's location on your body before charging. 1. Place the blue Charging Coil in the mesh pouch on the Charger Belt and securely attach belt around the waist. 2. Initiate charging and move the Charging Coil until it links with the Implant. 3. If you want to be mobile during charging, insert the Charger into the holster. Then clip the holster to your belt or pants. The Charging Coil can be inserted into the mesh pouch through the opening at the top of the Charger Belt Charger Belt Charger Holster Video instructions are available at www.NevroHFX.com/en/resources/remote-control/. For full instructions on the accessories, warnings, and precautions, please refer to the Patient Manual. Important information: Rx Only. Patient experiences with the Senza® spinal cord stimulation (SCS) system may vary by individual, including the amount of pain relief. The occurrence of adverse effects associated with SCS implant surgery or use also varies by patient. Patients should consult a physician to understand the benefits and risks of treatment with SCS. Please see the Senza Manual available at www.nevro.com/manuals for complete information including indications for use, contraindications, warnings/ precautions, and adverse effects. © 2024 Nevro Corp. All rights reserved. SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. S004118 Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 USA www.Nevro.com Tel. 1.650.251.0005 Toll-free 1.888.956.3876 16