Use and Care of the NeuRx Diaphragm Pacing System

Use and Care of the NeuRx
Diaphragm Pacing System®
Providing the next treatment for respiratory insufficiency
through the application of neurostimulation
Synapse Biomedical, Inc.
info@synapsebiomedical.com
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NeuRx® Diaphragm Pacing System for
ALS Intended Use &
Contraindications
HUMANITARIAN USE DEVICE
Authorized by Federal Law for use in the treatment of chronic hypoventilation in
ALS patients. The effectiveness of this device for this use has not been
demonstrated.
INTENDED USE
The NeuRx Diaphragm Pacing System (DPS)® is a percutaneous, intramuscular,
diaphragm motor point stimulating device intended for use in amyotrophic lateral
sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions)
as demonstrated by voluntary contraction or phrenic nerve conduction studies,
and who are experiencing chronic hypoventilation (CH) , but not progressed to an
FVC less than 45% predicted. For use only in patients 21 years of age or older.
CONTRAINDICATIONS
None known.
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NeuRx® Diaphragm Pacing System
for ALS Warnings
WARNINGS
If the patient uses the device full time, then the patient must always have a backup means of breathing help (ventilation) available. Healthcare provider’s should
instruct the patient to follow directions in the use of the NeuRx DPS®. The
patient should NOT use the NeuRx DPS® if they are pregnant. Healthcare
providers should instruct patients to NOT have any food or liquid in their mouth
when they start conditioning. NeuRx DPS® could interfere with some medical
equipment. Some medical equipment could interfere with the NeuRx DPS®.
Instruct patients to call their healthcare provider who is helping them with their
NeuRx DPS® before having any of the following: implanted cardiac pacemaker
or defibrillator, surgery, magnetic resonance imaging (MRI) test, diathermy
treatment, external electrical stimulation such as transcutaneous electrical
nerve stimulation (TENS), or shortwave or microwave therapy. Instruct patients
NOT to use this device if the skin around the electrode wires gets swollen,
infected, or inflamed. Instruct patients NOT to use the NeuRx® EPG in an
oxygen enriched environment or near a flammable anesthetic mixture with air,
oxygen or nitrous oxide.
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NeuRx® Diaphragm Pacing System
for ALS Precautions
PRECAUTIONS:
If the patient thinks the device is not providing enough stimulation, instruct them to
call their healthcare provider. Some patients may feel skin irritation or sensitivity
because of the NeuRx DPS®. Patients should call their healthcare provider if this
occurs. Avoid touching the patient cable or electrode wires to other metal objects.
To avoid damage to the device, keep this device out of the reach of children. Do
NOT attempt to open the NeuRx® External Pulse Generator (EPG). Do NOT drop
the NeuRx® EPG. Do NOT allow the NeuRx® EPG to get wet.
Instruct patients NOT to get wet while using the NeuRx® EPG. This includes
bathing, showering, swimming, or any other activity in which you could get wet.
Instruct patients NOT to have the EPG connected during any type of electrical
diagnostic test such as an electromyogram (EMG) or electrocardiogram (ECG).
Electromagnetic Interference: When using the NeuRx® EPG around electrical
equipment, instruct patients to check the NeuRx® EPG screen to make sure the
EPG is working. Instruct patients NOT to use cables or accessories with their
NeuRx® EPG other than those specified.
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Procedure Risks
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There is a risk of diaphragm penetration during the procedure,
which could cause a condition known as capnothorax
There is a risk of infection and/or inflamed tissue at the
electrode implantation sites
There is a risk of bleeding at the electrode implantation sites
There is a risk of nerve, tissue or organ damage as a result of
the procedure
There is a risk that the electrode wires could break off in the
body leading to reduced or intermittent diaphragm pacing or
failure of the NeuRx DPS®
There is a risk of cardiac arrhythmia being caused by the
placement of the electrodes in the chest cavity
Procedure Risks
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Do NOT use in patients with an implanted cardiac stimulator
unless a medical opinion from a specialist has first been
obtained and testing for device-device interaction is performed.
(Insufficient clinical data is available, at this time, to establish
safety with a cardiac pacemaker)
This product should not be used by patients with suspected or
real heart problems
There is a risk of skin irritation or hypersensitivity from the
electrical stimulation or from the tape used with the electrodes
or from the Connector Holder bandage that holds the electrode
connections
There is a risk that the body may not be compatible with the
materials used in the electrodes and their wires
Procedure Risks
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There is a risk of discomfort during use of the NeuRx DPS®
There is a risk that the patient may not have sufficient muscle
reaction when using the NeuRx DPS® and the product may not
work
The safety of this device in use during pregnancy is unknown
IDE Reported Adverse Events
Adverse Effect of Device or Surgery
Serious
Nonserious
(Patients)
(Patients)
Surgical/Perioperative
respiratory failure
(subsequent to PEG dislodgement)
capnothorax
postsurgical discomfort
infection
1
2
(1%)
(2%)
13 (15%)
5 (6%)
1 (1%)
Device Usage
discomfort from stimulation
infection at percutaneous exit site
skin irritation
pain at percutaneous lead exit site
other misc. singular reports
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22 (26%)
8 (9%)
5 (6%)
3 (4%)
9 (11%)
®
DPS
NeuRx
Respiratory NeuroStimulation
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Indications for Use in ALS
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Intended for use in ALS patients with stimulatable diaphragms and who
are experiencing chronic hypoventilation, but not progressed to an FVC
less than 45% predicted. For use only in patients 21 years of age or older.
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Chronic hypoventilation as measured by either;
– FVC less than 50% predicted
– MIP less than 60 cm H2O
– PCO2 greater than or equal to 45 mm Hg
– SaO2 less than 88% for 5 consecutive minutes during sleep
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Phrenic nerve function as tested by either;
– Visualizing diaphragm contraction with fluoroscopy (a full motion x-ray)
– Neurophysiological testing
– By radiographic techniques (such as ultrasound).
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Device Description
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The NeuRx DPS® is a system designed to help ALS patients
breathe by providing conditioning stimulation of their diaphragm
muscles and, when possible, providing breathing assistance
It is implanted using standard laparoscopic surgical techniques
in an outpatient procedure.
The implanted intramuscular diaphragm electrodes are
connected to the NeuRx® External Pulse Generator (EPG)
through the Patient Cable and the Connector Holder site.
The NeuRx® EPG provides repetitive electrical stimulation to the
implanted electrodes to cause the patient’s diaphragm to
contract and move in a manner similar to natural breathing.
Probable Benefit
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The patients who used the NeuRx DPS® plus non-invasive ventilation (NIV)
survived16 months longer (on average) than patients who just used NIV. This
16 month time frame is from the time of diagnosis. Survival time was
measured until death or the need for a full time ventilator and a tube in the
throat (tracheostomy). The patients who just used NIV were similar patients in
a different study.
The patients who used the NeuRx DPS® plus NIV survived 9 months longer
(on average) than patients who just used NIV. This is from the time they
started using NIV.
Some patients had a feeding tube placed with the NeuRx DPS®. All of these
patients survived past 30 days. Normally, 2 to 25 patients out of 100 (up to a
fourth of all patients) would not survive this long.
Some patients could not get used to or were unable to use NIV but used the
NeuRx DPS®. They survived an average of 16 months after getting the NeuRx
DPS®.
Some patients had their sleep tested after using the NeuRx DPS® for 4
months. They tended to have better sleep than before they received NeuRx
DPS®.
NeuRx DPS® Patient Kit
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This is programmed by the care team for the patient to use at
home.
Functional Features
Locate the POWER buttons on
the front of the EPG
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The buttons must be pressed at
the same time as a safety feature
guarding against inadvertent
activation.
Functional Features
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The EPG has a Liquid Crystal
Display (LCD) that provides
EPG operational information.
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The EPG indicates the Breathper-Minute (BPM) and when the
individual electrodes are active.
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Functional Features
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During the inspiration phase, a letter
‘A’, ‘B’ or “C” is shown below each
output number indicating that the
EPG is working well.
Functional Features
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When the EPG is not sending
electrical stimulation to the
diaphragm and the patient is
exhaling, a ‘-’ character is
shown below each electrode
number (1, 2, 3, and 4) on the
screen indicating that the
NeuRx® EPG is not active.
Functional Features
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If ‘X’ appears below one or more
output numbers, this may
indicate:
– one or more electrode wires may
be loose in the electrode
connector or broken.
– The patient cable is broken or
not connected properly.
– The NeuRx™ EPG is broken.
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Please follow the troubleshooting
guide provided in the
patient/caregiver manual. If you
observe one or more electrode
wires are loose or broken,
contact the implanting physician
to discuss repair options.
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Functional Features
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The NeuRx®EPG has been
programmed with settings that
meet the patient’s needs for
conditioning. In the event that a
‘?’ appears below an electrode
number (1, 2, 3, or 4) on the
screen, it should be followed by
a letter (A, B, or C).
This can occur normally when
the electric signal is set at a low
value.
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Conditioning Session
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The NeuRx® DPS is used to condition the patient’s diaphragm. In
conditioning, the NeuRx® EPG sends a small amount of electricity
through the wires to the diaphragm. This causes the diaphragm to
contract. When the diaphragm is conditioned, it will do a better job of
helping the patient‘s breathing.
Conditioning Warnings
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STOP the conditioning session if:
– The patient notices any change in heart rate or a feeling of chest
discomfort.
– The patient has shortness of breath or if any discomfort persists or
worsens.
– The patient wants to eat or drink.
– The patient or caregivers cannot manage secretions.
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Patient’s should avoid eating or drinking while conditioning with the
NeuRx DPS®. There is a risk of food or liquid entering the lungs. If the
patient use the NeuRx DPS® full time, discuss with the patient ways to
reduce the risk of food or liquid entering the lungs.
Instruct the patient NOT to bathe, shower, swim or participate in
any other aquatic activities while using the NeuRx® EPG. The
NeuRx® EPG is not waterproof. If the exit site gets wet, it should be
cleaned with an alcohol wipe. Allow the alcohol to air dry before use.
Assembly of EPG
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Wash and dry hands before starting the conditioning session.
Clear secretions from mouth before conditioning and continue it
throughout the conditioning session.
Connect the patient cable to the electrode connector. To do this, hold
the electrode connector between two fingers. Slide the patient cable,
with “Synapse Biomedical” facing you, into the connector holder.
Secure the patient cable to the electrode connector.
Assembly of EPG
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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
Disassembly of EPG
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Press the two buttons at the same time to turn the NeuRx® EPG on.
When the conditioning session is over, press the two buttons at the
same time to turn the NeuRx® EPG off.
To disconnect the patient cable from the NeuRx® EPG, firmly hold the
EPG in one hand. Grasp the cable with two fingers as shown and pull.
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Disassembly of EPG
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Disconnect the patient cable from the electrode connector. To do this,
hold the electrode connector between two fingers. Gently pull the
patient cable out of the connector holder
Store all items in the patient kit provided
Battery Installation
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The patient should replace the battery every 500 hours of NeuRx
DPS® use. This is about every 20 days if the patient is using NeuRx
DPS® full time.
The NeuRx® EPG screen will initially show “REPLACE BATT”. It will
alarm for 10 seconds every hour when the battery needs to be
replaced.
Replace the battery immediately if the NeuRx® EPG screen shows
“LOW BATTERY” and if the NeuRx® EPG alarms for 20 seconds every
minute.
Battery Installation
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Make sure that the NeuRx® EPG is turned OFF prior to replacing the
battery.
Use the provided flat blade screwdriver to loosen the screws on the
back bottom of the NeuRx® EPG. Remove the battery cover located
on the back bottom of the NeuRx® EPG.
Remove the old battery. Replace it with a new battery.
Alarms
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The NeuRx® EPG sounds an alarm if it detects any of the following
problems:
A beep lasting the duration of each inhaled breath will sound:
– if the patient cable gets disconnected from the NeuRx® EPG or if the connection
is loose.
– if the patient cable gets disconnected from the electrode connector or if the
connection is loose.
– if an exiting electrode wire is broken at the electrode connector.
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The alarm will repeat until the problem is resolved.
A beep lasting 10 seconds will sound and “REPLACE BATT” appears on the
screen. The 10 second alarm repeats once every hour. This means the
NeuRx® EPG has switched to the internal backup battery and it is time to
replace the main battery.
A beep lasting 20 seconds will sound and “LOW BATTERY” appears on the
screen. The 20 second alarm repeats once every minute. This means the
internal backup battery is low and it is time to replace the main battery
immediately.
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Care of the Exit Site
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Caregivers should wash and dry their hands before caring for the exit
sites.
Using two fingers, grasp the electrode connector and tilt it down as
shown.
Care of the Exit Site
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Remove the electrode connector from the connector holder. Now
remove the connector holder .
Care of the Exit Site
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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.
Care of the Exit Site
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Once dry, place the electrode connector into a new connector holder
as shown. Snap the electrode connector down into the connector
holder. The gold pins should be facing out for the cable to plug into
them.
Care of the Exit Site
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Carefully remove the paper backing from a new connector holder.
Make sure you do NOT pull on the exiting electrode wires
Care of the Exit Site
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Carefully press the new connector holder onto the skin.
Care of the Exit Site
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Place a 2” X 2” gauze pad over the exiting electrode wires
Care of the Exit Site
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Place a transparent dressing over the gauze. (Tegaderm™ and OpSite™ are examples of transparent dressings.) Do NOT cover the
gold pins with the transparent dressing
How to Shower or Bathe
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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.
Allow it to air dry before use.
How to Shower or Bathe
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Before bathing, disconnect the patient cable from the electrode
connector
How to Shower or Bathe
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Before bathing, cover the wires and the connector holder with a gauze
pad and a waterproof dressing
When you are done bathing, carefully uncover the wires and the
connector holder.
If you notice moisture on the electrode connector, wipe it with an
alcohol wipe. Use a wipe with 70% isopropyl alcohol. Allow the
alcohol to air dry before use.
Questions??
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