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Synapse NeuRx Information And Instruction Manual

Diaphragm pacing system
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NeuRx Diaphragm Pacing System® 
Patient/Caregiver Information and 
Instruction Manual 
For Amyotrophic Lateral Sclerosis 

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Questions and answers

Becky
June 17, 2025

Will the neurx diaphragm pacing system patient kit, SCI cause brady rate? On the cardiac monitor it shows Sinus brady however there is a pattern of electrical interference.

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Summary of Contents for Synapse NeuRx

  • Page 1 NeuRx Diaphragm Pacing System®  Patient/Caregiver Information and  Instruction Manual  For Amyotrophic Lateral Sclerosis ...

  • Page 2: Table Of Contents

    BACKUP INDIFFERENT ELECTRODE INTERCONNECT ........38   CLINICAL STUDIES ....................41   WARRANTY STATEMENT ..................41   ® TRAVELING WITH THE NeuRx DPS ............... 42   SERVICE ........................42   REPLACEMENT PARTS ................... 42   STORAGE AND DISPOSAL OF PARTS ..............42  ...

  • Page 3: Glossary Of Terms

     ECG (electrocardiogram) – test to check the electrical activity of the heart. The test helps to see if there has been a heart attack, an irregular heartbeat, or other heart problems.  Electrode Connector – a part of the NeuRx DPS ® which connects the electrode wires to the patient cable.
  • Page 4 ® EPG (external pulse generator ® box) to the electrode wires. It carries the electrical signal from the NeuRx EPG the wires.  Percutaneous Electrode Wire – thin wire which is used to send a small amount of electricity to the diaphragm muscle. One end of the wire is implanted in the diaphragm.

  • Page 5: Device Description

    See Figure 2 on page 7 for a drawing showing where the electrode wires are implanted in the body. This drawing also shows the position of the electrode wires, the patient cable, and the NeuRx EPG.
  • Page 6 Electrode Electrode Connector Wires Connector Holder Patient Cable NeuRx ® External Pulse Generator (EPG) Figure 1. NeuRx External Pulse Generator (EPG), Patient Cable, Connector Holder, Electrode Connector, and Electrode Wires.
  • Page 7 Figure 2. Location in the body where the four NeuRx DPS electrode wires (A) are implanted in the diaphragm. A yellow arrow points to each of the four wire implant locations. The patient cable (B) carries the electrical signal from the EPG (C) to the...

  • Page 8: Contraindications

    It is over this path that your brain sends messages to inhale. Both the ® right and left phrenic nerves must be at least partially working for the NeuRx DPS work. Your phrenic nerves can be tested by your neurologist.

  • Page 9: Warnings And Precautions

    , then you should use your ® back-up means right away. If you think there is any problem with your NeuRx DPS then you should use your back-up means right away. When you switch to your back- up means of breathing help, you should turn off the NeuRx DPS ®...
  • Page 10 NeuRx DPS may not cause your diaphragm to contract. CAUTION: Some patients may feel skin irritation or sensitivity because of the NeuRx ® . This may be due to the stimulation. It may also be due to the adhesive on the skin bandage.
  • Page 11 (EMG) or electrocardiogram (ECG). The use of the EPG during such tests could interfere with those tests. CAUTION — ELECTROMAGNETIC INTERFERENCE: Some electrically powered ® equipment gives off electromagnetic waves which could interfere with your NeuRx EPG.  When using your NeuRx ®...

  • Page 12: Risks And Probable Benefits

    System was evaluated in a clinical study. The study involved 106 patients at 9 hospitals (8 in the U.S. and 1 in France). From the 106 patients in the study, 86 would have met the indications for the NeuRx DPS ®...
  • Page 13 Table 1. Serious adverse events from the study which related to the device or the surgery. Reported Reported Occurrence Serious Occurrence (Likelihood) of Adverse Effect Adverse Event (Likelihood) of Serious Adverse Adverse Effect Event 1 out of 2 patients who 2 out of 86 catheter placement had serious...
  • Page 14 (about 1 out of the body every 3 patients)  No patients had to return to surgery to fix.  The NeuRx DPS system does not wire under skin deliver therapy until repair. 18 out of 86 in chest area patients ...
  • Page 15 6 out of 86 ® No NeuRx DPS therapy can occur broken NeuRx ® patients without a working NeuRx ® EPG. A ® replacement NeuRx EPG can be shipped (in about 1 out of (stimulator) to the patient.
  • Page 16  Problem interactions with some medical equipment: o High-frequency surgical equipment may cause burns where the ® electrode wires pass through the skin. It might also damage the NeuRx EPG if connected. o MRI could cause the electrode wires to move. MRI could also cause unwanted tissue heating through the electrode wires.

  • Page 17: Alternative Procedures And Treatments

    They tended to have better sleep than before they received NeuRx DPS ® ADDITIONAL INFORMATION Another study was done after the Food and Drug Administration approved the NeuRx ® . The “post-approval study” involved 60 patients at 10 hospitals in the U.S. The study results are in a report called the “Post-Approval Clinical Study Summary”...

  • Page 18: Before Surgery: What To Expect

    ALS and respiratory symptoms, or an FVC less than ® 50%, should be offered NIV. In general, NIV may be used with the NeuRx DPS Mechanical ventilation. At some point, ALS reduces the ability to breathe so much that invasive ventilation becomes the only choice for survival.

  • Page 19: After Surgery: What To Expect

    Before you leave the hospital, the staff will give you detailed instructions on how to ® ® use the NeuRx DPS . You will also be given this manual. You will use the NeuRx DPS to condition your diaphragm. In conditioning, the NeuRx ® EPG sends a small amount of electricity through the wires to your diaphragm.

  • Page 20: Functional Features

    When the EPG sends electricity to the diaphragm to trigger inhaling, a letter “A”, “B” or “C” is shown below each of the ® electrode wire numbers (1, 2, 3, and 4). This shows that the NeuRx EPG is working ®...
  • Page 21 During exhaling, a ‘-’ character is shown below each electrode number (1, 2, 3, and 4) ® on the screen (Figure 5). This means that the NeuRx EPG is not active. It is not sending electrical stimulation. Figure 5. “-“ shows that the NeuRx ®...

  • Page 22: Conditioning Session

    NeuRx EPG at least 3 times per day. Each ® session should last at least 30 minutes. You may find it helpful to use the NeuRx EPG for longer periods to help with breathing. The NeuRx ®...
  • Page 23 Figure 8. Connecting the patient cable to the electrode connector. ® 4. Insert the other end of the patient cable into the top of the NeuRx EPG. To do this, line up the arrows on the patient cable with the top of the EPG. Push the cable into the connection until it is secure (Figure 9).
  • Page 24 5. Press the two buttons at the same time to turn the NeuRx ® EPG on. 6. When the conditioning session is over, press the two buttons at the same time ® to turn the NeuRx EPG off. 7. To disconnect the patient cable from the NeuRx ®...

  • Page 25: Conditioning Warnings

    Do NOT have any food or liquid in ® your mouth when you start conditioning. If you use the NeuRx DPS full time, talk to your healthcare provider who is helping you with your NeuRx DPS ®...
  • Page 26  IMPORTANT: Use only the kind of battery specified in this manual. Do ® NOT use a standard alkaline battery in the NeuRx EPG.  IMPORTANT: Put the battery in the correct position (see Figure 13 on page 27). 4. Replace the battery cover and secure with mounting screws.
  • Page 27 Figure 13. Replacing the disposable battery.

  • Page 28: Alarms

     When in use, the one end of the patient cable should fit securely into the ® electrode connector. The other end should fit securely into the NeuRx EPG.  Arrange the patient cable so that it is comfortable. It should allow you to move around without pulling on the exit site connector.

  • Page 29: Care Of The Exiting Electrode Wires

    Figure 14. Patient Cable. CARE OF THE EXITING ELECTRODE WIRES  Do NOT pull on the electrode wires coming through the skin.  Do NOT cut the electrode wires.  Use extreme caution when shaving the skin around the electrode wire exit site. CARE OF EXIT SITES AND CONNECTOR ...

  • Page 30: Care Of Exit Sites

    CARE OF EXIT SITES The steps described below will show you how to take care of the “exit sites”. The exit sites are the locations where the electrode wires pass through your skin. These steps will show you how to: ...
  • Page 31 3. Remove the electrode connector from the connector holder. Now remove the connector holder (Figure 16). Figure 16 4. Clean the exit sites with an alcohol wipe (with 70% isopropyl alcohol). Always wipe toward the exit site. Allow the alcohol to air dry before use (Figure 17). Figure 17...
  • Page 32 5. Once dry, place the electrode connector into a new connector holder as shown in Figure 18. Snap the electrode connector down into the connector holder. The gold pins should be facing out for the cable to plug into them. Figure 18 6.
  • Page 33 7. Carefully press the new connector holder onto the skin (Figure 20). Figure 20 8. Place a 2” X 2” gauze pad over the exiting electrode wires (Figure 21). Figure 21 9. Place a transparent dressing over the gauze. (Tegaderm™ and Op-Site™ are examples of transparent dressings.) Do NOT cover the gold pins with the transparent dressing (Figure 22).

  • Page 34: How To Shower Or Bathe

    HOW TO SHOWER OR BATHE CAUTION: Do NOT get wet while using the NeuRx ® EPG. This includes bathing, ® showering, or swimming. The NeuRx EPG is not waterproof. If the exit site gets wet, clean it with an alcohol wipe. Use an individually packaged pad saturated with 70% isopropyl alcohol.

  • Page 35: Cleaning Of Components

    ® EPG is not working properly or multiple “X”s appear on the screen, please follow the steps below: 1. Check the connection between the patient cable and the NeuRx ® EPG. Check the connection between the patient cable and the electrode connector. Make sure these connections are secure.
  • Page 36 Use the following troubleshooting guide to help solve problems with your NeuRx EPG: Problem Action  Check the connection of the patient cable to the electrode connector.  Check the connection of the patient ® cable to the NeuRx EPG.
  • Page 37 The NeuRx EPG beeps for 20 seconds Replace the main battery right away. ® every minute. (This means the NeuRx See the Battery Installation section of this EPG is running on its backup battery and manual for the steps. the backup battery is getting low.)

  • Page 38: Backup Indifferent Electrode Interconnect

    This is called the backup connector for short. It is part number 22-0026 of the patient kit. The backup connector may be useful when the indifferent electrode under the skin has failed. This is when the NeuRx ®...
  • Page 39 2. Remove the backup connector (Figure 27) and the surface anode (Figure 28) from the kit. Figure 27. Backup Indifferent Electrode Interconnect Figure 28. Surface Anode Packet 3. Remove one surface anode (Figure 29) from the packet. Connect the brown cable to the white cable (Figure 30).
  • Page 40 4. Plug the backup connector into the electrode connector that is secured in the connector holder (Figure 31 and Figure 32). Figure 32 Figure 31 5. Remove the plastic backing from the surface anode. Place the surface anode on the patient near the electrode connector holder. Plug the patient cable into the backup connector (Figure 33).

  • Page 41: Clinical Studies

    86 patients. See the Risks and Probable Benefits section of this manual for the study results. WARRANTY STATEMENT The NeuRx EPG has a one year unconditional warranty from the date of installation. The patient cable has a 90-day unconditional warranty from the date of installation.

  • Page 42: Traveling With The Neurx Dps

    You should check the Transportation Security Administration website for the latest advice. The address is: http://www.tsa.gov/travelers/airtravel/specialneeds/index.shtm SERVICE You should not try to fix the NeuRx ® EPG on your own. Units needing service should be returned to Synapse Biomedical, Inc.

  • Page 43: Specifications (Details Of Device Operation)

    SPECIFICATIONS (DETAILS OF DEVICE OPERATION) This section is included to comply with safety standards. Power Source 3.6-volt lithium battery Battery Life 500 hours Operating Temperature +41 to +100ºF Storage Temperature +20 to +140ºF Relative Humidity 10% to 85% Pulse Waveform type regulated-current biphasic Pulse Amplitude 5mA to 25mA...

  • Page 44: Label Symbols

    LABEL SYMBOLS Below is an explanation of the symbols used on this product and its packaging. SYMBOL EXPLANATION This symbol appears on the back of your EPG. It is just a reminder to look into this manual first when you have questions. This symbol appears on the back of your EPG.

  • Page 45: User Assistance

    For assistance with your NeuRx DPS device including troubleshooting, first call your ® healthcare provider who is helping you with your NeuRx DPS . Below are spaces to write down your healthcare provider’s name and phone number: Healthcare Provider Name: ___________________________________________...
  • Page 48 300 Artino Street Oberlin, Ohio 44074 U.S.A. www.synapsebiomedical.com Tel: 1-888-767-3770 1-440-774-2488 Fax: 1-440-774-2572 France +33 (0) 9 60 12 44 98 Other European Countries +33 (0) 1 64 95 23 99 © Synapse Biomedical Inc. 2019 All Rights Reserved 77-0055 Rev B...

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