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Medtronic
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7434A
User Manual
154 pgs2.67 Mb0

Medtronic 7434A User Manual

User Manual
Rx Only
Itrel®EZ™Model 7434A Patient Programmer
Programmer Battery
Neurostimulator Battery
Explanation of Symbols on Products and Packaging
Keypad Symbols
Stimulation Control
Switch Symbols
Status Light Symbols
Neurostimulator Off
Increase
Rate
Volume Off
High Volume
Neurostimulator On
Decrease
Amplitude
Pulse Width
Low Volume
Neurostimulator Off
Neurostimulator On
Beeper Volume Control
Switch Symbols
Miscellaneous Symbols
Positioning Symbol IEC 60601-1/EN60601-1,
Type BF Equipment
Antenna Connector
Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive 90/385/EEC.
For U.S. audiences only.
Equipment has been tested and accepted for listing under the Canadian Standard Association, for distribution in Canada.
Storage Temperature Atmospheric Pressure
Relative Humidity
c
®
/
Refer to the appropriate product to see symbols that apply.
Risk Class 2
w
XX %
XX %
XXX hPa XX.X in. Hg
XX hPa XX.X
in. Hg
hPa
Attention, see accompanying documents
9V
To turn the neurostimulator on:
a) Press the Neurostimulator
On key. Listen for the confirmation beep.
b) Check that the
green Neurostimulator On light is lit. This light stays on for 8 seconds after you release the key.
To turn the neurostimulator off:
a) Press the Neurostimulator
Off key. Listen for the confirmation beep.
Medtronic
®
Itrel® EZ
™
Model 7434A
9V
To turn the neurostimulator on or off:
Place the programmer over your neurostimulator.
Itrel®EZ
™
Patient Programmer
Quick Programming Guide
Green Neurostimulator “On“ Light
b) Check that the
yellow Neurostimulator Off light is lit. This light stays on for 8 seconds after you release the key.
Yellow Neurostimulator “Off“ Light
Back of Patient Programmer
2
3
1
Location of Neurostimulator
To adjust amplitude, rate, or pulse width:
Remove the battery compartment cover.
Select the stimulation setting: amplitude ( ), rate ( ), or pulse width ( ).
Place the programmer over your neurostimulator.
Press the neurostimulator On key. Listen for the confirmation beep.
+
l
SN
9V IEC-6LR61
Press the Increase ( ) or the Decrease ( ) key to make a change. You should hear one beep for each change.
Repeat steps 2-5 for other stimulation settings. Replace the battery cover.
SOUND ACTION
One beep You have pressed the On/Off or
Increase/Decrease key and the change was received by the neurostimulator.
Three Indicates one of the following: rapid • You tried to adjust the beeps lowest neurostimulator beyond
theor highest settings.
• You tried to increase stimulation with the neurostimulator turned off.
5
6
2
3
4
1
If the patient programmer beeps:
A COMPANY DEDICATED TO PATIENTS
Medtronic was founded in 1949 by Earl Bakken, a graduate student in electrical engineering, and his brother-in-law, Palmer J. Hermundslie. Today Medtronic is the world leader in medical technology, pioneering therapies that restore health, extend life, and alleviate pain.
From its modest beginnings in a 600-square-foot Minneapolis garage, we have transformed Medtronic into a worldwide company that serves customers in more than 120 countries. Each year, millions of patients are treated with Medtronic products and therapies. We invest almost $500 million each year in research and development, working closely with the world’s leading physicians and scientists to enhance our current products and therapies, and to develop new ones. Although we are a large company, individual patients and their needs are still the driving force behind what we do and how we do it.
Our goal is to improve the quality of your life. This booklet, which provides information about your stimulation system, is one small way we try to help.
Welcome to the Medtronic family. We wish you well.
CONTENTS
ABOUT THIS BOOKLET.................................................................. 1
INTRODUCTION ............................................................................... 3
Indications..................................................................................................3
Contraindications .....................................................................................3
Warnings .................................................................................................... 4
Precautions ................................................................................................ 6
Risks of Surgery ........................................................................................
9
Possible Side Effects.............................................................................. 10
Changes in Therapy............................................................................... 10
Possible Device Complications ...........................................................
11
RECOVERING FROM SURGERY................................................. 12
Healing..................................................................................................... 12
Physical Therapy and Medications..................................................... 12
Activities...................................................................................................
13
WHAT IS PAIN? ................................................................................ 15
WHAT IS STIMULATION AND HOW DOES IT
MANAGE PAIN?............................................................................. 15
i
WHAT DOES YOUR STIMULATION SYSTEM
LOOK LIKE?..................................................................................... 17
HOW DOES YOUR STIMULATION SYSTEM WORK? ...........19
HOW DOES STIMULATION FEEL?............................................. 22
HOW IS YOUR ITREL 3 SYSTEM IMPLANTED?......................25
WHAT DOES THE PATIENT PROGRAMMER DO?................ 30
HOW DOES THE PATIENT PROGRAMMER WORK? ........... 31
PATIENT PROGRAMMER FEATURES ....................................... 32
Keypad...................................................................................................... 33
On/Off Keys ..................................................................................... 34
Increase and Decrease Keys ........................................................... 34
Control Switches .................................................................................... 35
Stimulation Control Switch ........................................................... 36
Beeper Volume Control Switch ..................................................... 37
Symbols and Status Lights................................................................... 38
Symbols.............................................................................................. 38
Status Lights...................................................................................... 38
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USING THE PATIENT PROGRAMMER ..................................... 41
Placing the Programmer over the Neurostimulator ....................... 41
Checking the Neurostimulator Battery ............................................. 43
Turning the Neurostimulator On and Off......................................... 45
Adjusting Your Stimulation .................................................................. 52
Programming Tips............................................................................ 53
Decreasing the Amplitude to the Lowest Setting........................ 56
Adjusting the Pulse Width.............................................................. 57
Adjusting the Rate............................................................................ 60
Adjusting the Amplitude ................................................................ 62
ACCESSORIES................................................................................... 65
Wrist Strap and Carrying Case ........................................................... 65
Detachable Antenna.............................................................................. 67
Attaching the Antenna over the Neurostimulator...................... 69
Connecting the Antenna to the Patient Programmer ................. 71
Disconnecting the Antenna............................................................. 71
Caring for the Antenna.................................................................... 73
Caring for Your Skin ........................................................................ 74
Using your Control Magnet (Optional) ............................................ 75
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CARING FOR YOUR PATIENT PROGRAMMER..................... 79
Battery Cover .......................................................................................... 79
Removing the Battery Cover .......................................................... 79
Replacing the Battery Cover .......................................................... 80
Identification Label................................................................................ 81
Checking the Programmer Battery..................................................... 83
Removing the Battery............................................................................ 85
Installing the Battery ............................................................................. 86
Cleaning and Care................................................................................. 88
Service ...................................................................................................... 90
Battery and Device Disposal................................................................ 90
TROUBLESHOOTING..................................................................... 92
LIVING WITH YOUR STIMULATION SYSTEM.................... 102
Patient Identification Card ................................................................. 102
When to Call Your Doctor................................................................... 104
Do’s and Don’ts.................................................................................... 106
Environmental Problems.................................................................... 108
Battery Information................................................................................112
Battery and Device Disposal.............................................................. 113
Medical and Dental Procedures........................................................ 114
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COMMONLY ASKED QUESTIONS........................................... 117
SPECIFICATIONS........................................................................... 123
SPECIAL NOTICE........................................................................... 124
LIMITED WARRANTY.................................................................. 125
GLOSSARY....................................................................................... 134
WARRANTY REGISTRATION CARD....................................... 139
QUICK PROGRAMMING GUIDE ............................................. 141
7
General Warning
The Medtronic®Itrel®EZ™Model 7434A Patient Programmer (the “Programmer“) is designed to program the adjustable parameters of the Medtronic®Itrel®3 Implantable Neurostimulator (the “neurostimulator“). Do not attempt to use the programmer on another device (for example, a cardiac pacemaker). Radio signals from the patient programmer may interfere with the performance of other implantable devices.
v
FCC INFORMATION
The following is communications regulation information on the Itrel
®EZ™
Model 7434A Patient Programmer.
FCC ID: LF57434A
This device complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.
IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product.
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page vi
ABOUT THIS BOOKLET
For over 30 years, stimulation has helped thousands of patients manage their pain. This has also improved their quality of life. Your stimulation system may be used with other pain treatments like physical therapy or medicine. Stimulation will not cure your pain. It may, however, reduce your pain to a tolerable level. As a result, you may be able to resume your daily activities.
1
This booklet provides you with the following:
• Indications, contraindications, warnings, precautions, risks of
surgery, possible side effects, changes in therapy, and possible device complications
• What to expect as you recover from surgery
• Definition of pain and stimulation
• Description of your implanted system and how it works to
manage your pain
• Description of your patient programmer, and how to use it and
care for it
• Steps to take to help you solve problems or identify when you
should call your doctor
• How to live with your stimulation system
• Answers to common questions
• Important terms that appear as bold in text; these terms are
listed in the Glossary at the end of this booklet.
Ask your doctor to explain anything that is unclear.
2
INTRODUCTION
Indications
The Medtronic®Itrel®3 System is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.
Patients should be carefully selected to assure that their pain is of physiologic origin. Also, patients must be appropriate candidates for surgery.
7 Caution
All other uses remain investigational.
Contraindications
Implantation of an Itrel 3 System is contraindicated for:
• Patients for whom trial stimulation is unsuccessful.
• Patients who are unable to properly operate the system.
3
Warnings
Case Damage—If the neurostimulator case is pierced, severe burns could result.
Equipment Operation—Do not use potentially dangerous equipment (cars, power tools, etc.) when your neurostimulator is on. What may feel like a sudden increase in stimulation (“jolt“ or “shock“) could cause you to lose control of the equipment you are using. Turn the neurostimulator off and set the amplitude to the lowest setting.
Postural Changes—As your spine moves, you may sense an increase or decrease in the stimulation. It may seem as though the neurostimulator is turning on or off. When you bend over or move suddenly, you may even feel an uncomfortable “jolt“ or “shock.“
Pregnancy—Safety for use during pregnancy or delivery has not been established.
4
Theft Detectors and Screening Devices—Use care when approaching theft detectors and security arches (such as those found in airports, libraries, and some department stores) as these devices can cause momentary, uncomfortable, or painful stimulation. Similarly, avoid airport security wands.
When approaching these devices do the following:
1. Show your patient identification card to security staff. Ask that
you be allowed to bypass the security device, request a hand search, or ask that the security device be turned off.
2. If passing through the security device is unavoidable, turn the
neurostimulator off.
3. Reduce the amplitude to the lowest setting.
4. Approach the security device slowly. If any stimulation is felt,
back out of the security device immediately without changing body position. If no stimulation is felt, move quickly through to the other side.
5
Precautions
Patient Management—To ensure the most benefit from your system, regular appointments with your doctor are recommended.
Medical Procedures—Some medical procedures can damage the neurostimulation system or can cause changes to the system which may produce discomfort, pain, or injury. Consult your doctor about risks and benefits of procedures such as:
• Electrosurgery (surgery performed using electrical methods)
• Diathermy (heat treatment)
• Lithotripsy (the crushing of a blockage within the urinary tract
using electrical methods)
• Radiation therapy (that is, cancer treatment)
• Magnetic resonance imaging (MRI)—not recommended
• Defibrillation (electric shock to the heart)
6
Electromagnetic Interference (EMI)—Strong electrical fields, such as those produced by radio towers or some industrial equipment, can affect the function of your neurostimulator. This can cause uncomfortable stimulation (a “jolt“ or “shock“). This problem is called electromagnetic interference, or EMI.
High/Low Pressure Effects—The effects of high/low pressure (that is, scuba diving, unpressurized airplanes) on patients with an implanted neurostimulation system are unknown.
7
Home Appliances—Be sure that appliances and equipment are properly installed and in good working condition before using them.
Occupational Environments—Strong interference could cause your neurostimulator to deliver inappropriate or additional stimulation to your spinal cord. Turning the neurostimulator off may reduce the effect of interference. Devices or equipment to avoid are theft detectors, airport/security screening devices, electric arc welding equipment, electric substations and power generators, CB or ham radio antennas, electric induction heaters used in industry to bend plastic, TV/radio transmitting towers, or electric steel furnaces.
8
Risks of Surgery
Implanting the Itrel 3 System has the same risks as any other neurostimulation implant procedure. These risks include:
• Spinal fluid leak, headache
• Fluid collection (seroma) or bruising (hematoma) at the
neurostimulator site
• Bleeding near the spinal cord (epidural hemorrhage or
hematoma) or paralysis
• Infection
9
Possible Side Effects
Side effects of spinal cord stimulation are usually mild and go away when stimulation is turned off. Possible side effects include:
• Chest wall stimulation
• Uncomfortable stimulation
• Jolting or shocking sensation
• Pain at the surgery sites
Changes in Therapy
There may be changes in the level of your pain control over time. In most cases, your doctor can correct these changes without surgery. However, it is possible that surgery may be required.
10
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Possible Device Complications
• There may be pain, redness, or swelling at the neurostimulator
site more than 6 weeks after surgery.
• The lead may move; surgery may be needed to reposition the
lead.
• The system may wear through your skin; this can cause an
infection or scarring.
• Pain control may decrease or stop due to device problems. One
example is the lead or extension wires could break.
Note: Do not twist or turn the system through your skin;
this can disconnect or damage the system.
• Your body may have an allergic response to implanted
materials.
11
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RECOVERING FROM SURGERY
Healing
It takes several weeks to heal from surgery. You will feel some discomfort from the incision(s). You will also have some pain at the neurostimulator site for 2 to 6 weeks. This pain is normal.
Physical Therapy and Medications
Your physician may also prescribe physical therapy, medication, or both to help manage your pain. Always follow your doctor’s instructions for the therapy(ies) prescribed.
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Activities
During your recovery (about 6 weeks), follow your doctor’s advice. Avoid activities where you must bend, stretch, or twist your body; this can move your lead and alter your stimulation.
To prevent lead movement, AVOID the following activities during your recovery:
• Lying on your stomach
• Reaching over your head
• Turning from side to side
• Bending forward, backward, or from side to side
• Lifting more than 5 pounds
13
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As you begin to feel better, you should be able to return to activities such as:
• Bathing or showering
• Sexual activity
• Working at home or at your business
• Hobbies or other activities such as walking, gardening, cycling,
or swimming
• Traveling
Discuss any type of strenuous activity with your doctor first, to avoid any possible damage to your system. Remember that returning to your daily activities should make you feel better, not worse.
Note: As you adjust to life with better pain control, you
may want to try activities that you could not perform before your surgery. Discuss this with your doctor first.
14
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WHAT IS PAIN?
Nerve signals from all over your body travel to your spinal cord, and then to your brain. Your brain translates nerve signals into feelings such as pressure, itching, tingling, or pain. It is your brain that feels pain, not the area of your body where the signal started.
WHAT IS STIMULATION AND HOW DOES IT MANAGE PAIN?
Stimulation delivers tiny electrical pulses to the spinal cord. This
blocks the pain signal as it travels to the brain. If the signal does not reach the brain, the pain is not “felt.“
Note: Stimulation will not cure your pain nor will it block
sharp pain caused by a recent injury.
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16
Stimulation blocks pain signals as they move to the brain.
Pain signal moving to brain is blocked by stimulation
Pain signal is moving to brain from painful foot
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 16
WHAT DOES YOUR STIMULATION SYSTEM LOOK LIKE?
A typical stimulation system has three implanted parts: one neurostimulator, one lead, and one extension.
Neurostimulator: The neurostimulator is the power source of your
system. It contains a special battery and electronics to control the stimulation you feel.
Note: In time, the battery inside your neurostimulator will
wear out. When this occurs, your neurostimulator will need to be surgically replaced.
Lead: The lead (pronounced “leed“) is a thin wire covered with a
protective coating. The lead has small metal electrodes near the tip. The lead is surgically placed with the metal electrodes near your spinal cord. The electrodes transmit tiny electrical pulses to the area where your pain signals will be blocked.
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Extension: The extension is a thin wire placed under the skin. It
also is covered with a protective coating. The extension connects to the neurostimulator at one end and to the lead at the other end.
The parts of your stimulation system.
18
Extension
Neurostimulator
Lead
Electrode
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 18
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