NeuRx Patient-Caregiver Instruction Manual

LABEL SYMBOLS Below is an explanation of the symbols used on this product and its packaging. Refer to the appropriate product to see symbols that apply.

CONTROL SWITCH SYMBOLS CAUTION ON/OFF switch buttons. Must be pressed simultaneously to activate and deactivate the Stimulator.

SYMBOL EXPLANATIONS

FOLLOW INSTRUCTIONS FOR USE IEC 60601-1, Type BF Equipment Conformite Europeene (European Conformity) This symbol means that the device fully complies with Medical Device Directive 93/42/EEC. IPX4

The device is protected from splashing water. Output voltages may approach 50 volt D.C. during operation. Serial Number Moustapha Diop Synapse Biomedical - Europe 156 Place des Aubépines 95680 Montlignon France 6

WARNINGS Use only under the direction of a physician. This device is electrically powered and may produce tissue damage or electrical hazard if improperly used. Do NOT attempt to open the Stimulator case; the device has NO patient-accessible controls. A patient with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to electrical stimulation unless a medical opinion from a specialist has first been obtained. The patient should avoid trans-thoracic stimulation. A potential safety hazard exists if there is a connection of the patient to a high-frequency surgical equipment and to the external stimulator simultaneously that may result in burns at the site of the stimulator electrodes and possible damage to the stimulator. A potential safety hazard exists when operating in close proximity (for example 1m) to shortwave or microwave therapy equipment that may produce instability in the stimulator output. The patient should avoid accidental contact between connected but unused applied parts (cable or leads) and other conductive parts including those connected to protective earth. The long-term effects of chronic electrical stimulation are unknown. Safety has not been established for the use of the device during pregnancy. It should not be used in patients with suspected heart problems or epilepsy. This device should not be used if skin in the area is swollen, infected, or inflamed or if there are skin eruptions such as phlebitis, thrombo phlebitis, or varicose veins. This device should be kept out of the reach of children unless it is being used for specific treatment.

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ELECTROMAGNETIC INTERFERENCE WARNING The NeuRx™ RA/4 Stimulator needs special precautions regarding electromagnetic compatibility (EMC) and needs to be put into service according to the EMC information provided. Portable and mobile RF communications equipment can affect the NeuRx™ RA/4 Stimulator. Use of cables or accessories other than those specified may result in increased emissions or decreased immunity of the NeuRx™ RA/4 Stimulator.

FLAMMABILITY WARNING The NeuRx™ RA/4 Stimulator is not intended to be used in an oxygen-enriched environment. The NeuRx™ RA/4 Stimulator is not categorized as an AP or APG type of equipment and must not be used near a flammable anesthetic mixture with air, oxygen or nitrous oxide.

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PRECAUTIONS Spinal Cord Injury (SCI) patients must have a mechanical ventilator available at all times. If you do not feel that you are receiving adequate ventilation or if any malfunction of the pacing device is suspected, you should be placed on mechanical ventilation immediately and the pacing system turned off. Do not expose the pacing device to excessive moisture or severe mechanical shock. If display indicates system failure, pain is felt at the electrode site, or device is exposed to moisture or shock, disconnect the cable and contact Synapse Biomedical. Precautions should be observed when there is a tendency to hemorrhage following acute trauma or fracture, following recent surgical procedures when muscle contraction may disrupt the healing process, or where sensory nerve damage is present. Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation, the adhesive on the skin bandage, or the transparent dressing (Tegaderm™ and Op-Site™ are examples of transparent dressings) used over the gauze that covers the electrodes. Contact your physician or center if this occurs as irritation can usually be reduced by changing the stimulus parameters or removing the adhesive. Diathermy treatment and electro cauterization should be avoided in the area of the implanted electrodes. The stimulator should be disconnected during any types of electrical diagnostic treatment such as EMG or ECG.

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DEVICE DESCRIPTION The NeuRx Diaphragm Pacing System™ is a system designed to help patients breathe by stimulation of their diaphragm muscles. It is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to the NeuRx™ RA/4 External Stimulator through the Patient Cable and the Connector Holder site.

Connector Holder Electrode wires

Patient Cable

Stimulator

Skin Bandage

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The stimulator provides repetitive electrical stimulation to the implanted electrodes to cause the patient’s diaphragm to contract and cause the patient to draw breath in a manner similar to natural breathing. Your physician will program the Stimulator so that it produces the right stimulation patterns for you. If the stimulation makes you uncomfortable, tell your physician as he or she can adjust the Stimulator to reduce or eliminate the discomfort. The user simply connects the device to the implanted electrodes and turns it on for use; no other controls are available or necessary for operation. During use, the stimulator should be kept close to the patient’s body to avoid pulling on the cable and electrodes. The stimulator can be placed in a pocket of the patient’s clothing, a fanny pack or simply placed on a table or other convenient location.

FUNCTIONAL FEATURES The cable should be securely inserted into the exit site connector and the top of the stimulator. The stimulator is programmed with parameter data that satisfies the patient’s specific requirements. To turn the stimulator ON: Depress the two buttons on the front of the stimulator simultaneously. To turn the stimulator OFF: Depress the two buttons on the front of the stimulator simultaneously. The buttons must be depressed simultaneously as a safety feature guarding against inadvertent activation. The stimulator has a Liquid Crystal Display (LCD) that provides stimulator operational information.

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RA-4 15 RPM

1234 AAAA

The stimulator indicates the Breath-per-Minute (BPM) rate and when the individual electrodes are active. During the inspiration phase, a letter ‘A’, ‘B’ or “C” is shown below each output number indicating that the stimulator is working well. During the expiration phase, a ‘-’character is shown below each output number indicating that the stimulator is not active. In the event that an ‘X’ appears below an output number, then a problem exists and your physician, center or Synapse Biomedical should be contacted. The backup Stimulator may be carried with the patient as a spare Stimulator. It can be used at any time and may be helpful when diagnosing Stimulator or patient cable issues. The backup Stimulator should be cleaned and stored just like the Stimulator you use daily. Your physician, center or Synapse Biomedical should be contacted when issues are discovered. In the event that a ‘?’ appears below an output number, it should be immediately followed by a letter. This can occur normally when the pulse modulation parameter is set at a high value or when the pulse width parameter is less than 50 μsec. Your stimulator has been programmed with settings that have been established during your conditioning session. This is considered a normal event.

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SCI PATIENT INFORMATION Patients with high-level spinal cord injuries typically experience chronic ventilatory insufficiency due to respiratory muscle paralysis. These patients historically have been supported predominantly through positive pressure mechanical ventilation. Alternatively, patients may be ventilated through activation of the nerves that cause the diaphragm to contract and create an inspiration. A device such as the NeuRx DPS™, that is surgically implanted in the diaphragm, does this and has given SCI patients the ventilatory support and freedom to experience a normal breathing pattern with the NeuRx DPS™ device as long as they have an intact phrenic nerve. The first step in using the NeuRx DPS™ device is the process of increasing diaphragm muscle strength. Patients who have long standing and significant respiratory paralysis will require conditioning of the diaphragm muscle in order to sustain ventilation. The more you condition, the stronger your diaphragm will become. Conditioning can happen every hour. In the beginning, the recommended stimulator usage for SCI patients is 15 to 30 minutes each session. As your diaphragm gets stronger, the length of your sessions should increase and the number of daily sessions should decrease. You should allow 45-60 minutes between sessions to allow your diaphragm to fully recover. Always consult your physician before making any changes to your daily pacing sessions.

CONDITIONING SESSIONS The following describes the process of one conditioning session: • • • • •

Secretions should be cleared prior to conditioning and managed throughout the conditioning session. Connect patient cable to orange connector block and to the stimulator. Place pulse oximeter on patient and continuously monitor throughout conditioning session. Turn stimulator on and remove from ventilator. Allow patient to get comfortable on stimulator (2 – 3 minutes) and measure tidal (breath) volumes with Respirometer. Make note of 13

•

•

• • • •

tidal volume, pulse oximeter reading and any comments, complaints, or discomforts. At the midway point of a conditioning session, measure tidal (breath) volumes with Respirometer. Compare to initial readings and, using the BORG scale below, determine the effort to breathe. Make note of tidal volume, pulse oximeter reading and any comments, complaints, or discomforts. If your effort to breathe on the BORG scale is 4 or greater you should discontinue the session and return to your mechanical ventilator. If your pulse oximeter reads below 90% you should discontinue the session and return to your mechanical ventilator. Prior to ending a conditioning session, measure tidal (breath) volumes with Respirometer. Make note of tidal volume measurements, pulse oximeter reading, breathing effort, and any comments, complaints, or discomforts. When conditioning session is over, place back on the ventilator and turn the stimulator off. Disconnect patient cable from orange connector block. Allow approximately 45-60 minute rest period between sessions. You should review your conditioning notes with your physician to determine increases in your conditioning time.

BORG Scale (breathing effort): 0 = No Breathlessness at all 1 = Very Slight Breathlessness 2 = Slight Breathlessness 3 = Moderate Breathlessness 4 = Somewhat Severe Breathlessness 5 = Severe Breathlessness 7 = Very Severe Breathlessness 10 = Maximum Breathlessness

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CONDITIONING WARNINGS •

The conditioning session should stop and you should be placed back on the ventilator if you notice any change in heart rate or feeling of chest discomfort. If you have a cardiac pacemaker it should be evaluated to make sure there is no diaphragm pacemaker to cardiac pacemaker interaction.

•

The conditioning session should stop and you should be placed back on the ventilator: o o o o

If signs of shortness of breath or any discomfort persists or worsens. If oxygen level remains below 90%. If management of secretions becomes difficult. Your Borg scale is 4 or greater.

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You should always wear a Passy- Muir™ valve while sleeping to help prevent obstructive sleep apnea. Contact your physician if you do not already have one.

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Caution should be used when eating and drinking while conditioning. A Passy-Muir™ valve should be worn during these conditioning sessions to reduce the risk of aspiration.

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An abdominal binder should be worn only when you are in your chair as this may improve your tidal (breathing) volumes.

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External electrical stimulation should not be done in the chest area.

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ALS PATIENT INFORMATION Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease or Motor Neuron Disease) is a progressive neurodegenerative disease of unknown cause. One of the most important effects of progressive neuromuscular weakness in patients with ALS is the effect on respiration. Although ALS has no direct effect on the lung, it has devastating effects on all of the major respiratory muscle groups: upper airway muscles, expiratory muscles, and inspiratory muscles. Therefore, all patients with ALS are at significant risk for respiratory complications. Previous evidence suggests that peripheral muscle function can be preserved / improved in ALS patients with a technique of electrical muscle stimulation. The NeuRx DPS™ uses diaphragm pacing technology in an attempt to maintain respiratory muscle function in ALS patients. If successful, at least two significant benefits may occur: 1. 2.

Life threatening respiratory muscle dysfunction may be delayed in paced patients. Diaphragm pacing may be effective in ventilatory support of patients with ALS either decreasing or obviating the need for negative or positive pressure mechanical ventilation

The NeuRx DPS™ will slow the decline of pulmonary function, as defined by percent predicted forced vital capacity (FVC) to 30% of normal, by approximately twelve months. The NeuRx DPS™ connects to the diaphragm and delivers electrical current to stimulate the muscle contractions to preserve the diaphragm with the intended purpose of improving quality of life and slowing the progress to respiratory failure. The diaphragm pacing system will provide stimulation to the diaphragm muscle to maintain its strength and potentially help with the breathing problems associated with ALS. The recommended pacing sessions for ALS patients are intended to occur 3 to 5 times per day with each session lasting at least 30 minutes. Please consult with your physician if you would like to condition more than 5 times per day or longer than 30 minutes per session. You should allow 45-60 minutes between sessions to allow your diaphragm to fully recover. 16

CONDITIONING SESSIONS The following describes the process of one conditioning session: • •

• • • • •

Secretions should be cleared prior to conditioning and managed throughout the conditioning session. Connect patient cable to orange connector block and to the stimulator. Place pulse oximeter on patient and continuously monitor throughout conditioning session. Turn stimulator on. When conditioning session is over, turn the stimulator off. Disconnect patient cable from orange connector block. Document sessions on the conditioning log and include any complaints/discomforts noted in the comments section. Allow approximately 45-60 minute rest period between sessions.

CONDITIONING WARNINGS •

The conditioning session should stop and you should be placed back on the ventilator if you notice any change in heart rate or feeling of chest discomfort.

•

The conditioning session should stop and you should be placed back on the ventilator: o o

If signs of shortness of breath or any discomfort persists or worsens. If management of secretions becomes difficult.

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You should not eat or drink while conditioning.

•

External electrical stimulation should not be done in the chest area.

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ALARMS The stimulator initiates an audible alarm if it detects any of the following problems: • • •

If the connection from the cable to the box or the cable to the electrode wires becomes loose or disconnects A 10 seconds audible alarm will sound when the stimulator switches to the internal backup battery. The 10 second alarm repeats once every hour. A 20 second alarm will sound when the internal backup battery is low. The 20 second alarm repeats once every minute.

CARE OF CABLE • • • • • • • •

The cable connects the exit site connector (wires) to the stimulator. Do not cut, kink or pull the cable Do not manipulate the metal pins in the end pieces of the cable Do not immerse in water Keep extra cables in a dry secure location When in use, the cable should fit securely into the exit site connector and the stimulator The length of the cable should be long enough to provide comfort and allow range of motion without pulling on the exit site connector Notify your physician or center if the cable gets cut, kinked, falls in water, loose connection to exit site connector or stimulator 18

CARE OF LEADS • • •

Do not pull on the wires coming through the skin Do not cut the wires Use extreme caution when shaving skin area around wire site

CARE OF EXIT SITES & CONNECTOR • • •

• • • • • • • •

Keep the skin at the exit sites clean and dry Do not scratch skin at exit sites Clean the exit sites with alcohol wipe, allow alcohol to dry, place gauze dressing over the exit site. Be sure to cover all the wire with the gauze. Place a transparent dressing over the gauze. (Tegaderm™ and Op-Site™ are examples of transparent dressings) Change the dressings every 3 days or more often if the dressing becomes wet or otherwise soiled If the area becomes red, swollen, painful or drainage appears: notify your physician. Do not manipulate the metal pins in the connector The exit site connector should lie flat against the surface of the skin Observe that the electrode leads are properly positioned within the connector This connector will snap into a skin bandage (provided by the research team) Notify the research team if you there is a change in the appearance of the connector You should change the skin bandage weekly or if it becomes soiled

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CLEANING OF COMPONENTS •

The surfaces of the Stimulator may be cleaned and disinfected with a less than 6% bleach solution or a less than 10% isopropanol solution. Typical cleaners such as glass or multi-surface spray cleaners are adequate.

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The surfaces of the Patient cables may be cleaned with a mild antibacterial hand soap solution.

BATTERY INSTALLATION WARNINGS • • •

If the stimulator displays “LOW BATTERY” then replace the battery immediately! Ensure that the Stimulator is turned OFF prior to battery replacement. The device contains lithium-ion battery and that replacement by inadequately trained personnel could result in an explosion. Follow the following procedure:

BATTERY REPLACEMENT 9 9 9 9 9 9 9

Use only the battery specified on the Stimulator battery door. Do not use a standard alkaline battery in the Stimulator It is very important to install battery in the correct orientation It should be replaced every 500 hrs (3 weeks of full time pacing) The stimulator will initially display “REPLACE BATT” when your battery needs replaced. To change the battery, use the provided flat blade screwdriver to remove the battery cover located on the back bottom of the stimulator. Remove old battery and replace with new. Replace the battery cover and secure with mounting screws. Dispose of depleted batteries according to local regulations.

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TROUBLESHOOTING The following guide can be helpful in determining the source of problems with your DPS system: Problem

Action

Pacing of the diaphragm stops

1. Check the connections of the electrode leads to the Connector Holder 2. Check the connection of the Patient Cable to the Connector Holder 3. Check the connection of the Patient Cable to the Stimulator

Patient is not receiving adequate ventilation

Disconnect the Stimulator and return the patient to a ventilator

Patient Discomfort during pacing

Contact your physician. The Stimulator program may need adjustment

Bleeding, bruising, or infection of the electrode implantation site(s)

Contact your physician.

Patient feels pain at the electrode site

Disconnect the Stimulator first, then contact Synapse Biomedical

Skin irritation or hypersensitivity to stimulation

Contact Synapse Biomedical

Multiple “X”s appear on the Stimulator display

Disconnect the Patient Cable from the Stimulator and insert Test Plug. If problem persists then contact Synapse Biomedical

The Stimulator is exposed to substantial amount of water or fluid

Disconnect the Stimulator first, then contact Synapse Biomedical

A continuous audio alarm during the Inspiration Interval

1. Check the connections of the electrode leads to the Connector Holder 2. Check the connection of the Patient Cable to the Connector Holder 3. Check the connection of the Patient Cable to the Stimulator

The Stimulator beeps every hour

The Stimulator is running on its internal battery. Replace the main battery as described in this manual.

The Stimulator beeps every minute

The Stimulator is running on its internal battery and the internal battery is getting low. Replace the main battery immediately as described in this manual. 22

SERVICE The RA/4 External Stimulator has no user serviceable parts and it is recommended that if the unit becomes inoperable it is returned to Synapse Biomedical, Inc for service.

REPLACEMENT PARTS The following standard replacement parts may be ordered directly from Synapse Biomedical, Inc. as required. ITEM

PART NUMBER

Lithium Battery Patient Cable Connector Holder

ORDER QUANTITY

29-0007 22-0011 22-0004

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ACCESSORY The following accessory may be ordered directly from Synapse Biomedical, Inc. ITEM

PART NUMBER

ORDER QUANTITY

29-0018

1

Screwdriver

SPECIFICATION Power Source Battery Life Operating Temperature Storage Temperature Relative Humidity

3.6-volt lithium battery 500 hours +5 to +40 °C (+41 to +104 °F) -6 to +60 °C (+20 to +140 °F) 10% to 85%

Pulse Waveform-type Pulse Amplitude Pulse Width Pulse Period

Regulated-current biphasic 5mA to 25mA 10use to 200usec 20msec to 250msec

Inspiration Interval Inspiration Rate

0.8sec to 1.5sec 8 to 18 Breaths per Minute 23

GLOSSARY The following definitions are helpful in understanding the procedure and components of NeuRx Diaphragm Pacing System™. Alcohol Wipe – individually packaged pad saturated with 70% Isopropyl Alcohol used to cleanse the skin’s surface. For single use only. Connector Holder – a bandage with a special plastic “shell” attached that is used to end of the Patient Cable Covering Bandage – an adhesive bandage that covers the electrodes that exit the skin Diathermy – treatment procedure that uses high frequency energy waves to generate a deep heat of body tissues. Can be used as a treatment for pain relief Electrode (or Percutaneous Electrode) – specially made thin wire, which is placed through the skin into the diaphragm and used to deliver electrical stimulation. Electrode Connector – a plastic strip that the doctor connects one end of the Electrodes to, after implanting the other ends of the electrodes into the diaphragm EMG – Electromyography is a method for measuring muscle activity via the electrical signals produced by muscles when they are stimulated. ECG – Electrocardiogram is a recording of the electrical activity of the heart. IEC – International Electrotechnical Commission (IEC) is an international standards organization dealing with electrical, electronic and related technologies. Patient Cable – the covered wire that connects the Stimulator to the electrodes at the connector holder Programming – the process of entering personalized parameter data that satisfies the patient’s specific requirements into the stimulator Spasm – sudden involuntary or uncontrolled muscle tightening Stimulator – a battery-operated controller that is programmed to generate a controlled amount of electrical stimulation

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77-0035 Rev E