Synapse NeuRx Manuel utilisateur

NeuRxDiaphragmPacingSystem®

Patient/CaregiverInformationand

InstructionManual

ForAmyotrophicLateralSclerosis

TABLE OF CONTENTS

GLOSSARY OF TERMS .............................................................................................. 3

DEVICE DESCRIPTION .............................................................................................. 5

CONTRAINDICATIONS ............................................................................................... 8

INDICATIONS FOR USE ............................................................................................. 8

INFORMATION ON CONDITION OR DISEASE .......................................................... 8

WARNINGS AND PRECAUTIONS .............................................................................. 9

RISKS AND PROBABLE BENEFITS ......................................................................... 12

ALTERNATIVE PROCEDURES AND TREATMENTS ............................................... 17

BEFORE SURGERY: WHAT TO EXPECT ............................................................... 18

SURGERY: WHAT TO EXPECT ............................................................................... 18

AFTER SURGERY: WHAT TO EXPECT .................................................................. 19

FUNCTIONAL FEATURES ........................................................................................ 20

CONDITIONING SESSION ........................................................................................ 22

CONDITIONING WARNINGS .................................................................................... 25

BATTERY INSTALLATION ........................................................................................ 25

ALARMS .................................................................................................................... 28

CARE OF PATIENT CABLE ...................................................................................... 28

CARE OF THE EXITING ELECTRODE WIRES ........................................................ 29

CARE OF EXIT SITES AND CONNECTOR .............................................................. 29

CARE OF EXIT SITES ............................................................................................... 30

HOW TO SHOWER OR BATHE ................................................................................ 34

CLEANING OF COMPONENTS ................................................................................ 35

TROUBLESHOOTING – NeuRx® EPG ...................................................................... 35

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

SPECIFICATIONS (DETAILS OF DEVICE OPERATION) ......................................... 43

LABEL SYMBOLS ...................................................................................................... 44

USER ASSISTANCE .................................................................................................. 45

GLOSSARY OF TERMS

 Alcohol Wipe – individually packaged pad saturated with 70% isopropyl alcohol.

Used to cleanse the skin’s surface. For single use only.

 ALS (amyotrophic lateral sclerosis) – See the section of this manual called

Information on Condition or Disease.

 Arrhythmia – when your heart is beating either very slow, very fast or it feels like it

skips a beat. It is also called an irregular heartbeat.

 Arterial Blood Gas (ABG) – a blood test that measures the amounts of gases in

the blood. The gases measured are oxygen and carbon dioxide.

 Backup Indifferent Electrode Interconnect – can be used instead of the

“indifferent electrode” if that part fails. (“Indifferent Electrode” is explained further

down in this glossary.) The difference is that it goes on the skin instead of under

the skin.

 Capnothorax – a complication caused by air going through the diaphragm and

into your chest during the surgical procedure.

 Chronic Hypoventilation – state in which too little air enters the lungs. This

causes low levels of oxygen and high levels of carbon dioxide in the blood. This

can be due to breathing that is not deep enough or too slow.

 Conditioning – use of the NeuRx DPS® to cause the breathing muscle

(diaphragm) to contract.

 Connector Holder – plastic shell which holds the electrode connector against the

skin. Sticks to the skin with an adhesive like a bandage.

 Covering Bandage – a bandage that covers the electrode wires where they come

out through the skin.

 Diaphragm – the main muscle that is used for breathing.

 Diathermy Treatment – deep tissue heat treatment using energy from an

electrical device.

 DPS – See NeuRx DPS®.

 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.

 Electrode Wire – See Percutaneous Electrode Wire.

 EPG (NeuRx DPS® External Pulse Generator) (stimulator) – the part of the NeuRx

DPS® System that puts out the electrical signal which stimulates the diaphragm. It

runs on batteries. It is outside the body. It is connected (through the electrode

connector) to the electrode wires which go into the diaphragm.

 Exit Site (electrode wire exit site) – place where an electrode wire passes

through your skin.

 Forced Vital Capacity (FVC) – the volume of air that one can exhale from the

lungs with force.

 Indifferent Electrode – the one wire which is placed under the skin in the chest

area.

 Laparoscope – a small surgeon’s tool with a camera on the end. The surgeon

puts it into the abdomen through a half inch long incision. It lets the surgeon look

inside the abdomen without the need for a large incision.

 Maximum Inspiratory Pressure (MIP or PImax) – a measure of how well one can

breathe in.

 NeuRx DPS® (Diaphragm Pacing System) – device which sends a small amount of

electricity to the diaphragm muscle. This makes the diaphragm contract. Parts

include the electrode wires, the external pulse generator (“EPG”) box, and the

patient cable.

 Non-Invasive Ventilation (NIV) – breathing help from a small machine that uses a

mask that fits over the nose or nose and mouth.

 Patient Cable – cable which connects the NeuRx® EPG (external pulse generator

box) to the electrode wires. It carries the electrical signal from the NeuRx EPG® to

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. The other end is inserted in an electrode connector outside the body

over the chest area.

 Percutaneous Endoscopic Gastrostomy (PEG) – a tube through which nutrition

is given. It is inserted by a surgeon through the skin and into the stomach.

 Phrenic Nerves – the nerves which carry the signals that tell your diaphragm to

either inhale or exhale.

 Pulmonary Function Test (PFT) – breathing tests that show how well your lungs

are working (exhaling and inhaling). One such test checks the maximum amount

of air you can force out of your lungs (forced vital capacity or FVC). Another test

checks how strong your breathing muscles are when you breathe in (maximum

inspiratory pressure or MIP).

 Stimulator – See EPG (External Pulse Generator).

DEVICE DESCRIPTION

The name of the device is the NeuRx Diaphragm Pacing System (DPS)®. The NeuRx

DPS® has implantable parts and external parts. The implantable parts consist of five

electrode wires which go through the skin. The tips of four electrode wires are placed

into the diaphragm by your surgeon. The diaphragm is the breathing muscle. The tip

of the fifth electrode wire is placed under the skin in the chest area to complete the

wiring. The other ends of the five electrode wires come out through the skin in the

chest area. The outside ends of the electrode wires will be placed in an electrode

connector. The electrode connector is attached to the skin with the connector holder.

The connector holder has an adhesive patch like a bandage. The electrode connector

has a socket to plug in one end of the patient cable. The other end of the patient

cable is connected to the NeuRx® EPG. The NeuRx® External Pulse Generator (EPG)

is a stimulator box.

The patient kit contains the external parts. These parts include the NeuRx® EPG,

patient cables, batteries and connector holders. The patient cable goes between the

EPG and the electrode connector. The EPG is programmed by your healthcare

provider. The EPG sends electrical signals to the diaphragm. The signal causes the

muscle to contract in order to condition the muscle.

See Figure 1 on page 6 for a picture of the NeuRxTM EPG, patient cable, connector

holder, electrode connector, and electrode wires. 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.

Figure 1. NeuRxTM External Pulse Generator (EPG), Patient Cable, Connector

Holder, Electrode Connector, and Electrode Wires.

Electrode

Wires

Electrode

Connecto

Patient

Cable

Connector

Holde

NeuRx®

External

Pulse

Generator

(EPG)

Figure 2. Location in the body where the four NeuRxTM 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

electrode wires (A) which stimulate the diaphragm to contract.

CONTRAINDICATIONS

Are there Any Reasons Why You Should Not Use the NeuRx Diaphragm Pacing

System (Contraindications)? None.

INDICATIONS FOR USE

HUMANITARIAN USE DEVICE

Humanitarian 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.

CAUTION: Federal law (USA) restricts this device to sale, distribution and use by or

on the order of a physician.

The NeuRx Diaphragm Pacing System (DPS)® is a device. It is meant for patients

who have both ALS and diagnosed breathing problems. For the NeuRx DPS® to

work, your breathing muscle (diaphragm) must be able to respond to stimulation. This

can be shown before surgery by a diaphragm movement test or by a breathing nerve

test. You must be able to exhale at least 45% of the air that a typical healthy person

could (in an “FVC” test). You must also be 21 years of age or older.

The breathing nerves (phrenic nerves) provide a path from the spinal cord to the

diaphragm. 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® to

work. Your phrenic nerves can be tested by your neurologist.

See BEFORE SURGERY: WHAT TO EXPECT for information about these tests.

INFORMATION ON CONDITION OR DISEASE

Amyotrophic lateral sclerosis (ALS) is a disease that affects nerve cells in the brain

and the spinal cord. Certain nerve cells called motor neurons reach from the brain to

the spinal cord and from the spinal cord to the muscles throughout the body. When

the motor neurons die because of ALS, the ability of the brain to start and control

muscle movement is lost. Patients in the later stages of the disease may become

totally paralyzed.

Often ALS affects the motor neurons which reach to the muscles used in breathing. In

this way, ALS can cause the breathing problems described in the Indications for Use

section above.

For more about ALS see the website of the ALS Association: www.alsa.org/about-als

WARNINGS AND PRECAUTIONS

WARNING: If you use the device full time, then you must always have a back-up

means of breathing help (ventilation) available. If you do not feel that you are

receiving enough breathing help from the NeuRx DPS®, 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®.

WARNING: If this device is not used properly, it may cause injury or electrical hazard.

Follow your healthcare provider’s directions in the use of the NeuRx DPS®.

WARNING: Do NOT use the NeuRx DPS® if you are pregnant. It is unknown if it is

safe to use the NeuRx DPS® if you are pregnant. The clinical trial did not involve

pregnant women.

WARNING: Avoid eating or drinking while conditioning with the NeuRx DPS®. There

is a risk of food or liquid entering your lungs. 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® about the ways

to reduce the risk of food or liquid entering your lungs.

WARNING: NeuRx DPS® could interfere with some medical equipment. Some

medical equipment could interfere with the NeuRx DPS®. Call your healthcare

provider who is helping you with your NeuRx DPS® before having any of the following:

 Implanted cardiac pacemaker or defibrillator. The NeuRx DPS® may

interfere with these devices. There is not enough information to know for sure

whether your NeuRx DPS® can be used safely with these devices. Your

healthcare provider should get an opinion from a specialist. Your healthcare

provider should also test whether your NeuRx DPS® interferes with devices like

these if you need them.

 Surgery. Use of high-frequency surgical equipment may cause burns where

the electrode wires pass through the skin. It might also damage the NeuRx®

EPG if connected.

 Magnetic Resonance Imaging (MRI) test. The NeuRx DPS® has not been

tested with MRI. MRI could cause the electrode wires to move. MRI could also

cause unwanted tissue heating through the electrode wires.

 Diathermy treatment. Diathermy treatment is deep tissue heat treatment. It

should not be done around the implanted electrode wires. Unwanted tissue

heating through the electrode wires could occur.

 External electrical stimulation such as transcutaneous electrical nerve

stimulation (TENS). Such stimulation should not be done in the chest area

near the electrode wires. Unwanted diaphragm contraction could occur.

 Shortwave or microwave therapy. Operating the NeuRx DPS® close to

(about 3 feet from) such equipment may interfere with your NeuRx DPS®.

WARNING: Do NOT use this device if the skin around the electrode wires gets

swollen, infected, or inflamed. Call your healthcare provider who is helping you with

your NeuRx DPS®.

WARNING — FLAMMABILITY: Do NOT use the NeuRx® EPG in rooms or spaces

where oxygen is being used. This could cause a fire.

CAUTION: Federal law (USA) restricts this device to sale, distribution and use by or

on the order of a physician.

CAUTION: If you think the device is not providing enough stimulation, then call your

healthcare provider who is helping you with your NeuRx DPS®. This could mean that

the NeuRx DPS® may not cause your diaphragm to contract.

CAUTION: Some patients may feel skin irritation or sensitivity because of the NeuRx

DPS®. This may be due to the stimulation. It may also be due to the adhesive on the

skin bandage. It could also be due to the transparent dressing used over the gauze

that covers the electrode wires. (Tegaderm™ and Op-Site™ are examples of

transparent dressings.) Call your healthcare provider who is helping you with your

NeuRx DPS® if this occurs. Irritation can usually be reduced by changing the settings

of the EPG or removing the adhesive.

CAUTION: Avoid touching the patient cable or electrode wires to other metal objects.

Metal objects can conduct electricity. You may accidently get shocked from another

metal surface.

CAUTION: To avoid damage to the device, keep this device out of the reach of

children.

CAUTION: Do NOT attempt to open the NeuRx® External Pulse Generator (EPG).

Doing so can damage the device.

CAUTION: To protect the NeuRx® EPG against damage due to mechanical shock:

 Do NOT drop the NeuRx® EPG. The EPG may break and not be available for

use when needed.

 Use the protective black carrying case provided for transporting the NeuRx®

EPG when not in use.

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