Synapse NeuRx Скачать руководство пользователя страница 12 | Manualshive

Страница: 12 / 48

Synapse NeuRx Скачать руководство пользователя страница 12

12

RISKS AND PROBABLE BENEFITS

INTRODUCTION

The NeuRx DPS

®

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

®

. The results discussed

here are from those 86 patients. The results show that the benefits of using the
NeuRx DPS

®

System outweigh the health risks. Risks and probable benefits of the

NeuRx DPS

®

are described below. The results of the clinical study are also

described.

SURGICAL PROCEDURE RISKS

There are risks of the surgery to implant the electrode wires. These serious adverse
effects were seen in the study:



Breathing failure

occurred in one of the 86 patients in the study after surgery. This

patient also had a feeding tube inserted during the DPS surgery. The feeding tube
moved out of place and caused problems. Those problems led to the patient
needing breathing support, through a tube in their throat, from a breathing
machine.



Problems caused by the abdominal air getting through the diaphragm and going

into the chest cavity during the surgery (

capnothorax).

This happened in 15 out of

86 patients in the study (in about 1 out of every 6 patients). Two of these patients
(in about 1 out of every 43 patients) needed special treatment for this problem. In
one case, a small tube was placed in the chest for a short time. In one case, the
patient had to stay in the hospital longer than normal. In the other 13 patients (in
about 1 out of every 7 patients), the problem went away on its own.



Reaction to anesthesia.

One patient had a serious reaction to anesthesia. After

starting anesthesia in the operating room the patient had a low heart rate and low
blood pressure. The surgery was then cancelled before any incision was made.

«
...
10
11
12
13
14
...
»

Содержание NeuRx

Страница 1: ...NeuRx Diaphragm Pacing System Patient Caregiver Information and Instruction Manual For Amyotrophic Lateral Sclerosis ...

Страница 2: ...0 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 ...

Страница 3: ...ich 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 bandag...

Страница 4: ...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 o...

Страница 5: ...esive 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 ...

Страница 6: ...1 NeuRxTM External Pulse Generator EPG Patient Cable Connector Holder Electrode Connector and Electrode Wires Electrode Wires Electrode Connector Patient Cable Connector Holder NeuRx External Pulse Generator EPG ...

Страница 7: ... 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 A B C ...

Страница 8: ...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 CON...

Страница 9: ...er 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...

Страница 10: ...agm 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 yo...

Страница 11: ...s with a gauze pad and transparent dressing such as Tegaderm or Op Site If the exit site gets wet clean it with an alcohol wipe Use an individually packaged pad saturated with 70 isopropyl alcohol Allow the alcohol to air dry before use CAUTION Do NOT have the EPG connected during any type of electrical diagnostic test such as an electromyogram EMG or electrocardiogram ECG The use of the EPG durin...

Страница 12: ...nserted during the DPS surgery The feeding tube moved out of place and caused problems Those problems led to the patient needing breathing support through a tube in their throat from a breathing machine Problems caused by the abdominal air getting through the diaphragm and going into the chest cavity during the surgery capnothorax This happened in 15 out of 86 patients in the study in about 1 out ...

Страница 13: ... of 86 patients 1 2 tracheostomy mechanical ventilation 1 out of 1 patient who had respiratory failure related to the surgery anesthesia reaction 1 out of 87 patients 1 1 low heart rate bradycardia low blood pressure hypotension and cancellation of surgery 1 out of 1 patient who had serious anesthesia reaction 87 patients the 86 patients who were implanted and the 1 patient who was not implanted b...

Страница 14: ...justed in the healthcare provider s office None required removal of the wires discomfort from stimulation 22 out of 86 patients 1 out of every 4 patients Resolved in 20 patients Unresolved in 2 patients but tolerable the patients continued using the NeuRx DPS wire leading to diaphragm break outside the body 28 out of 86 patients about 1 out of every 3 patients Affected wire does not deliver therap...

Страница 15: ...placement NeuRx EPG can be shipped to the patient broken patient cables 4 out of 86 patients in about 1 out of every 22 patients No NeuRx DPS therapy can occur without a working patient cable Two cables are provided with each kit The patient cables are meant to be disposable More replacement cables can be shipped to patient pain where electrode wire passes through skin exit site 3 out of 86 patien...

Страница 16: ...to move MRI could also cause unwanted tissue heating through the electrode wires o Diathermy treatment equipment used for deep tissue heat treatment Unwanted tissue heating through the electrode wires could occur o External electrical stimulation such as transcutaneous electrical nerve stimulation TENS If this is performed in the chest area near the electrode wires unwanted diaphragm contraction c...

Страница 17: ...r 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 ADDITIONAL INFORMATION Another study was done after the Food and Drug Administration approved the NeuRx DPS The post approval study involved 60 patients at 10 hospitals in the U S The study results are in a report called the Post A...

Страница 18: ... you could be a candidate for the NeuRx DPS SURGERY WHAT TO EXPECT The surgeon will make a short cut incision in the skin of your abdomen This incision will give the surgeon access to your diaphragm The incision will be about half an inch long A tube will be placed into the incision Carbon dioxide gas will be pumped through the tube to fill your abdomen A small tool with a camera on the end laparo...

Страница 19: ...le tell your healthcare provider He or she can change the settings to reduce or eliminate the discomfort 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...

Страница 20: ...PM and when the individual electrode wires are active 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 properly The example in Figure 4 below shows the NeuRx EPG with AAAA on its screen This means that it is working properly during inhaling When any letter A B...

Страница 21: ...h settings that your healthcare provider determines are right for you A appearing below an electrode number 1 2 3 or 4 on the screen can occur normally when the EPG s electric signal is at a low level Figure 6 Later the should switch to a letter A B or C when the EPG s electric signal level gets high enough Figure 6 below an associated electrode wire number 1 2 3 or 4 can occur normally when the E...

Страница 22: ...h the wires to your diaphragm This causes your diaphragm to contract When your diaphragm is conditioned it will do a better job of helping your breathing Your healthcare provider will tell you how to use the NeuRx EPG You should condition your diaphragm with the 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 p...

Страница 23: ...To do this hold the electrode connector between two fingers Slide the patient cable into the connector holder Secure the patient cable to the electrode connector Figure 8 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 ...

Страница 24: ...y hold the EPG in one hand Grasp the cable with two fingers as shown and pull Figure 10 Figure 10 Disconnecting the patient cable 8 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 Figure 11 Figure 11 Disconnecting the patient cable from the electrode connector 9 Store all...

Страница 25: ...ol to air dry before use See additional information under the Warnings and Precautions section BATTERY INSTALLATION Replace the battery every 500 hours of NeuRx DPS use This is about every 20 days if you are using NeuRx DPS full time The NeuRx EPG screen will initially show REPLACE BATT It will alarm for 10 seconds every hour when your battery needs to be replaced Replace the battery immediately i...

Страница 26: ...ne 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 5 Follow the local regulations when you dispose of old batteries Figure 12 Loosen these screws on the battery cover to replace battery ...

Страница 27: ...27 Figure 13 Replacing the disposable battery ...

Страница 28: ...s may sound and LOW BATTERY appears on the screen The 20 second alarm repeats once every minute This means the internal backup battery is low It means that it is time to replace the main battery immediately CARE OF PATIENT CABLE The patient cable is shown in Figure 14 It runs between the electrode connector and the NeuRx EPG as shown in Figure 1 near the front of this manual Do NOT cut kink or pul...

Страница 29: ...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 soiled If the area becomes red swollen painful or drainage appears call your healthcare provider Avoid touching the metal pins in the electrode connector The connector holder should lie flat against the surface of the skin Cal...

Страница 30: ... a new connector holder apply a new connector holder onto the skin and cover the exiting electrode wires with gauze and transparent dressing You should perform these steps every 3 days or more often if the dressing becomes wet or otherwise soiled IMPORTANT REMINDER Do NOT pull the electrode wires Doing so may pull more electrode wire from under the skin See step 6 below 1 Wash and dry your hands b...

Страница 31: ...rom 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 ...

Страница 32: ...igure 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 Carefully remove the paper backing from a new connector holder Make sure you do NOT pull on the exiting electrode wires Figure 19 Figure 19 ...

Страница 33: ... 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 Figure 22 ...

Страница 34: ...70 isopropyl alcohol Allow it to air dry before use See more information under the Warnings and Precautions section The following instructions are written for bathing However these instructions should be followed for any activity in which you would get wet 1 Before bathing disconnect the patient cable from the electrode connector Figure 23 Figure 23 2 Before bathing cover the wires and the connect...

Страница 35: ...ly 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 2 Replace the patient cable with the spare cable in the patient kit 3 Disconnect the patient cable from the NeuRx EPG 4 Insert the test plug a When t...

Страница 36: ...hcare provider who is helping you with your NeuRx DPS Multiple X s appear on the NeuRx EPG screen Try a different patient cable If the problem continues disconnect the patient cable from the NeuRx EPG and insert the test plug found in the patient kit If the EPG is working properly use the Backup Indifferent Electrode Interconnect If the problem continues call your healthcare provider who is helpin...

Страница 37: ... beeps for 20 seconds every minute This means the NeuRx EPG is running on its backup battery and the backup battery is getting low Replace the main battery right away See the Battery Installation section of this manual for the steps ...

Страница 38: ... 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 EPG displays XXXX see Figure 25 below but the patient cable and EPG still work correctly Figure 25 EPG displaying XXXX Follow these steps to use the backup connector 1 Disconnect the patient cable from the electrode connector Figure 26 Figure...

Страница 39: ...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 Figure 29 Figure 30 ...

Страница 40: ...ecured in the connector holder Figure 31 and Figure 32 Figure 31 Figure 32 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 Figure 33 ...

Страница 41: ... or 4 CLINICAL STUDIES The NeuRx DPS System was evaluated in a clinical study The study was done at 9 clinical centers 8 in the U S and 1 in France There were 106 patients with ALS who received the device Eighty six patients had breathing problems like those described in the NeuRx DPS Indications for Use The risks and benefits of the NeuRx DPS are based on the results of these 86 patients See the ...

Страница 42: ...placement parts may be ordered from an authorized supplier ITEM PART NUMBER ORDER QUANTITY Patient Cable Lithium Batteries 3 per pack Connector Holder 30 per pack Surface Electrodes 4 per pack Airline Travel Batteries 3 per pack 22 0011 22 0020 22 0004 22 0034 22 0021 1 Each 1 pack 1 pack 1 pack 1 pack STORAGE AND DISPOSAL OF PARTS Store all parts at a temperature between 20ºF and 140ºF Secure par...

Страница 43: ...tery 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 Pulse Width 10usec to 200usec Pulse Period 20msec to 250msec Inspiration Interval 0 8sec to 1 5sec Inspiration Rate 8 to 18 breaths per minute ...

Страница 44: ...ppears on the back of your EPG It means that the EPG has met standards in Europe The device meets Medical Device Directive 93 42 EEC This has been certified by notified body number 0086 This symbol appears on the back of your EPG It means that it is protected against splashing water This symbol appears on the top of your EPG near the output connector It warns that output voltages may approach 50 v...

Страница 45: ...to write down your healthcare provider s name and phone number Healthcare Provider Name ___________________________________________ Healthcare Provider Phone Number ____________________________________ If you cannot reach your healthcare provider as a back up you may also call Synapse Biomedical Customer Service U S Toll Free 1 888 767 3770 From outside the U S 001 440 774 2488 ...

Страница 46: ...46 ...

Страница 47: ...47 ...

Страница 48: ...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 ...

Отзывы:

Нет отзывов