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7434A
User Manual
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Medtronic 7434A User Manual

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User Manual
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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.
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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
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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
HOW DOES YOUR STIMULATION SYSTEM WORK?
After your surgery, your doctor used a physician programmer (a small computer) to send stimulation instructions to your neurostimulator. These instructions control the stimulation you feel.
The instructions are stored in your neurostimulator. If needed, your doctor can use the programmer to change the instructions.
You have been given a patient programmer to use with your system. It allows you to turn your neurostimulator on and off. It also allows you to fine tune your stimulation. Your doctor or nurse will explain how to use the patient programmer. Refer to “Using the Patient Programmer,“ on page 41.
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An optional control magnet can also be used to turn your neurostimulator on and off. This magnet can also be used to start a dosage of stimulation if programmed by your doctor. You cannot use the control magnet to adjust amplitude.
If necessary, your doctor can disable the circuit that allows on/off control with the magnet.
A special code inside your neurostimulator allows only programming from the physician or patient programmer; other devices, such as the control magnet, are not able to program your neurostimulator.
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Neurostimulator controlling devices.
21
Itrel
®EZ™
Patient
Programmer
Control Magnet
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 21
HOW DOES STIMULATION FEEL?
Your neurostimulator sends tiny electrical pulses through the extension to the lead. The electrical pulses move through the lead and electrodes to the area where your pain signals will be blocked.
To most patients, these pulses feel like tingling in the pain area. Sensations vary from patient to patient.
When your neurostimulator is turned on, the tingling slowly increases until it levels off. When your neurostimulator is turned off, the tingling slowly decreases until it stops.
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Stimulation feels like tingling in the area of pain.
23
Painful Area
Stimulation Area
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 23
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.“
Do not be alarmed if these sudden changes in stimulation occur. The instructions inside your neurostimulator have not changed. Your movement has probably caused your spinal cord to move closer to or farther from the lead electrodes. For a moment, the stimulation may feel more or less intense than it should.
Sudden changes in stimulation like these are most common during the recovery period. They usually decrease as you heal and the lead becomes more secure in your spinal column.
24
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HOW IS YOUR ITREL®3 SYSTEM IMPLANTED?
Implantation of your Itrel®3 System has four basic steps and usually is done in one or two operations. The four steps are as follows:
• Lead placement
• Screening
• Neurostimulator internalization
• Neurostimulator programming
During the lead placement, you may be under a local anesthetic. The doctor will ask you to help determine when the lead is in the correct place. You will know the lead is correctly placed when you feel a tingling sensation in the area of your pain. This is the sensation you will feel instead of pain when your Itrel
®
3 System is
blocking pain.
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An external “screener“ device provides the energy for the trial stimulation during the lead placement. If your doctor chooses to internalize the system in one operation., the neurostimulator is implanted after a successful lead placement.
If the procedure is done in two operations, you will have a trial screening period of several days. Your doctor will use the “screener“ to determine the most comfortable and effective stimulation settings for you.
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The neurostimulator is internalized while you are under local or general anesthesia. This will occur after the screening period or, as previously explained, immediately after the lead placement. The doctor makes an incision in the skin, usually in the abdomen.
The neurostimulator is usually placed in the abdomen.
27
Neurostimulator
Extension
Lead
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 27
The neurostimulator is placed under the skin. The lead is then connected to the neurostimulator via the extension (wire). Your doctor will try to place the neurostimulator in an area that is most comfortable and cosmetically acceptable.
After the internalization, your doctor will use the physician programmer to program the neurostimulator to the therapy settings that are appropriate to your needs. Your doctor may also choose to program a SoftStart
™
/Stop stimulation. The SoftStart is a
feature that gradually increases the amplitude from zero (0) to the programmed amplitude when your neurostimulator is turned on. When you turn off the neurostimulator, SoftStop gradually decreases the amplitude to zero (0) before turning off.
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WHAT DOES THE PATIENT PROGRAMMER DO?
Use the patient programmer only with your implanted neurostimulator. DO NOT use the programmer on other devices (such as a cardiac pacemaker).
7
Warning
Signals (telemetry) from the patient programmer may disrupt the function of other implanted devices.
Your programmer is easy to use. You can use it to:
• Turn the neurostimulator on or off.
• Adjust the stimulation of your neurostimulator.
• Check the status of the neurostimulator battery and the
programmer battery.
• Confirm that the neurostimulator has received instructions
from the programmer.
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HOW DOES THE PATIENT PROGRAMMER WORK?
The patient programmer sends signals to your neurostimulator. These signals tell the neurostimulator to turn on or off or to change stimulation.
The neurostimulator also sends signals to the patient programmer. Signals from the neurostimulator confirm changes you have made. Signals also tell you the status of the neurostimulator battery.
The programmer placed over the neurostimulator.
31
Location of Neurostimulator
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 31
PATIENT PROGRAMMER FEATURES
This section describes the features of the patient programmer.
The patient programmer.
32
Keypad
Battery Cover
Battery Cover Release Tab
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 32
Keypad
The keypad has 4 keys: Neurostimulator On and Off keys, and Increase and Decrease keys.
The keypad.
33
Turns neurostimulator off
Increase and Decrease Keys
Turns neurostimulator on
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 33
On and Off Keys
Press the On and Off keys to turn the neurostimulator on and off.
Increase and Decrease Keys
A Stimulation Control switch, under the battery cover, is used to select the amplitude, rate, or pulse width. (See page 79 for information on removing the battery cover.) Press the Increase and/or Decrease key to adjust the amplitude, rate, or pulse width within ranges set by your doctor.
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Control Switches
The control switches and battery are located under the battery cover. For instructions on removing the battery cover, refer to page 79.
Control switches and battery.
35
Stimulation Control Switch
(Rate is selected)
Beeper Volume Control Switch
(High volume is selected)
Amplitude Rate Pulse
Width
Off
Low
High
Battery
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 35
9V IEC-6LR61
l
+
SN
Stimulation Control Switch
Depending on the instructions your doctor has programmed into your neurostimulator, you can adjust some or all of these settings with the Stimulation Control switch: amplitude, rate, and pulse width. Colors and symbols identify each setting (see below). Changing these settings will help you find the highest level of comfort and pain relief.
The amount or “volume“(strength or intensity) of stimulation required to mask your pain. This is the setting most often adjusted by patients.
The number of pulses per second; rate feels like “tapping.“
The length or duration of the electrical pulse. A longer pulse covers a larger area.
Note: The Increase and Decrease keys on your keypad
adjust the selected stimulation control.
36
Pulse Width
Rate
Amplitude
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 36
Beeper Volume Control Switch
The programmer beeps each time a change is received by your neurostimulator. Turn the beeper Off or set the volume to Low
or High with the Beeper Volume Control switch.
(See Table 1.)
Table 1. Beeper description.
If you hear It means
One beep You have pressed the On/Off or Increase/Decrease
key and the change was successfully received by your neurostimulator.
Three rapid beeps You tried to adjust the amplitude, pulse width, or
rate beyond the highest and lowest settings.
You tried to increase amplitude, rate, or pulse width with the neurostimulator turned off.
You pressed On while your neurostimulator was in “dose lockout.“ Some patients’ doctors set a lockout period during which no stimulation is delivered. You cannot adjust stimulation during the lockout.
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Symbols and Status Lights
The back of your programmer displays symbols and status lights. These will help you during a programming session.
Symbols
A positioning symbol helps you align your programmer over the neurostimulator.
An antenna symbol directs you to the detachable antenna connector. An optional, detachable antenna can be plugged in here.
Status Lights
When lit or blinking, the status lights tell you the following:
• Whether the neurostimulator is on or off
• The neurostimulator battery status
• The programmer battery status
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Symbols and status lights on the
back of the patient programmer.
Medtronic
®
Itrel® EZ
™
Model 7434A
9V
39
Green Programmer Battery Light
Green Neurostimulator “On“ Light
Green Neurostimulator Battery Light
Yellow Neurostimulator “Off“ Light
Detachable Antenna Symbol
Positioning Symbol
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 39
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USING THE PATIENT PROGRAMMER
This section is organized as follows:
• Placing the Programmer over the Neurostimulator
• Checking the Neurostimulator Battery
• Turning the Neurostimulator On and Off
• Adjusting Your Stimulation
Placing the Programmer over the Neurostimulator
Locate the neurostimulator implanted under your skin and hold the programmer over it. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator. To send and receive signals, hold the programmer steady over the neurostimulator for at least 1 second while you press any key. When you align the programmer correctly over the neurostimulator, two or more lights will shine.
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If the beeper is on, it will beep.
The lights and beeper tell you that you have lined up the programmer and neurostimulator and they are sending signals to each other. If only the programmer battery light is lit and the beeper does not beep, move the programmer an inch or two and try again.
42
Note: A detachable
antenna is also available. This is helpful for patients who cannot reach their neurostimulator. Refer to “Accessories“ on page 65 for more information.
Position the programmer over the
neurostimulator.
(Place against clothing or skin.)
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Checking the Neurostimulator Battery
The Neurostimulator Battery light on the back of the programmer tells you the status of your neurostimulator battery.
See page 112 for information on what to do when your battery runs down.
To check the neurostimulator battery:
1. Place the programmer over your neurostimulator. Hold the
programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
2. If your neurostimulator is off, press the Off key. If your
neurostimulator is on, press the On key. Hold the programmer over the neurostimulator for at least 1 second.
3. Confirm that the green Neurostimulator Battery light on the
back of the programmer is lit. Refer to Table 2 for more information about the Neurostimulator Battery light.
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44
Note: Move indoors or into the shade if sunlight dims
the programmer lights.
Table 2. Neurostimulator Battery lights.
When this happens It Means
Green Neurostimulator Battery light Neurostimulator battery is OK. is on for 8 seconds after pressing any key.
Green Neurostimulator Battery light The neurostimulator battery is low. is blinking for 8 seconds after Call your
doctor
’s office.
pressing any key.
Green Neurostimulator Battery light Reposition programmer and try again. is off after pressing any key. Interference from electrical equipment
can cause lights to remain off. Move to another room and try again. If the light remains off, the neurostimu­lator battery may need to be replaced. The neurostimulator should be reviewed with a physician programmer. Contact your doctor immediately.
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Turning the Neurostimulator On and Off
Turn your neurostimulator on when:
• You require pain relief, or
• You want to adjust the amplitude, rate, or pulse width.
Turn your neurostimulator off when:
• The amplitude is set at the lowest setting and you do not need
stimulation.
• You are using equipment that could be harmful to you or
others if you should receive a sudden shock (for example, driving a car).
• You are having a medical or dental procedure. See
“Precautions,” page 6.
• You are passing though a theft detector or a security device
such as those used in department stores and airports.
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Notes:
• Turning the neurostimulator off extends the battery life of your neurostimulator. When the battery wears out, the neurostimulator must be surgically replaced. You will want to make it last as long as possible.
• Decreasing the amplitude to the lowest setting will not turn off the neurostimulator.
7
Caution
To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting:
• After turning your neurostimulator off.
• Before adjusting the rate or pulse width of your neurostimulator.
After rate or pulse width are set, slowly increase the amplitude to your comfort level.
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To turn the neurostimulator on:
1. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
Place the programmer over the neurostimulator.
2. Press the Neurostimulator On key and hold the programmer over the neurostimulator for 1 second. If the beeper is on, you should hear one beep to confirm that a change has occurred.
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Location of Neurostimulator
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Press the Neurostimulator On key.
3. Check that the green Neurostimulator On light on the back of the programmer is lit; this indicates that the neurostimulator was successfully turned on (see Table 3). This light stays on for 8 seconds after you release the key.
Note: The neurostimulator will turn on with the settings
last programmed.
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To turn the neurostimulator off:
1. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
Place the programmer over the neurostimulator.
2. Press the Neurostimulator Off key and hold the programmer over the neurostimulator for 1 second. If the beeper is on, you should hear one beep to confirm that a change has occurred.
49
Location of Neurostimulator
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Press the Neurostimulator Off key.
3. Check that the yellow Neurostimulator Off light on the back of the programmer is lit; this indicates that the neurostimulator was successfully turned off (see Table 3). This light stays on for 8 seconds after you release the key.
Note: Move indoors or into the shade if sunlight dims the
programmer lights.
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4. Decrease the amplitude to the lowest setting (refer to pages 56 ­57 for instructions).
7
Caution
To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting after turning your neurostimulator off.
Table 3. Neurostimulator On and Off lights.
When It Means
The green Neurostimulator On light is lit Neurostimulator is on. for 8 seconds after pressing any key.
The yellow Neurostimulator Off light is lit Neurostimulator is off. for 8 seconds after pressing any key.
Neither Neurostimulator On nor Off The programmer does not know light is lit after pressing any key. if the neurostimulator is on or off
because it failed to communicate with the neurostimulator. Refer to “Troubleshooting,“ page 96.
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52
Adjusting Your Stimulation
Table 4 provides some general guidelines for when you should adjust your stimulation. Your doctor will provide more complete guidelines.
Table 4. When to adjust your stimulation.
Adjust the Amplitude Press This Key
Before you adjust rate or pulse width
After you turn the neurostimulator off
When the tingling is not strong enough
When the tingling is too strong
Adjust the Pulse Width Press This Key
If the tingling does not cover your pain area
If the tingling seems to cover too much area
Adjust the Rate Press This Key
If the tapping is uncomfortable
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 52
Programming Tips
The following tips are helpful when using the patient programmer.
7
Caution
To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting:
• After turning your neurostimulator off.
• Before adjusting the rate or pulse width of your neurostimulator.
After rate or pulse width are set, slowly increase the amplitude to your comfort level.
• Always set your neurostimulator to the lowest settings that provide pain relief. The higher the settings, the faster your neurostimulator battery will wear out. When the battery wears out, the neurostimulator must be surgically replaced. You will want to make it last as long as possible.
• Select amplitude, rate, or pulse width using the Stimulation Control switch. The Increase and Decrease keys will adjust the stimulation setting that you select.
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• The neurostimulator must be on to increase amplitude, rate, and pulse width. However, the neurostimulator may be either on or off to decrease the amplitude, rate, or pulse width.
• Use the lights on the back of the programmer to confirm that a change is taking place. The Neurostimulator On or Off lights, the Programmer Battery light, and the Neurostimulator Battery light should be lit after sending a change to the neurostimulator. This confirms that the neurostimulator is turned on or off, and that the neurostimulator and the programmer batteries are OK. These lights stay on for 8 seconds after you release the key.
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• If the beeper is on, the programmer will beep once for each change that is programmed into your neurostimulator. Your programmer will beep three times if you try to increase a stimulation setting when the neurostimulator is off. It will also beep three times if you have reached the lowest or highest value for the selected setting (amplitude, rate, or pulse width). The programmer will beep three times if you press On while the system is in “dose lockout.“
• You can increase or decrease settings more quickly by pressing and holding down the desired key. Every second, the programmer will send a change to the neurostimulator.
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Decreasing the Amplitude to the Lowest Setting
Always decrease the amplitude to the lowest setting before adjusting pulse width and rate or after turning your neurostimulator off.
1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.)
2. Move the Beeper Volume Control switch to Low or High .
3. Move the Stimulation Control switch to amplitude .
Move the Stimulation Control switch to amplitude.
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61
57
4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
5. Press and hold the Decrease key until the programmer beeps rapidly three times. This reduces the amplitude to the lowest setting.
Note: The neurostimulator may be on or off when
decreasing amplitude.
6. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.)
Adjusting the Pulse Width
1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.)
2. Decrease the amplitude to the lowest setting as described on page 56.
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7
Caution
To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting before adjusting the pulse width or rate of your neurostimulator. After rate or pulse width is set, slowly increase the amplitude to your comfort level.
3. Move the Stimulation Control switch to pulse width .
Move the Stimulation Control switch to pulse width.
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1
4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
5. Press Neurostimulator On to turn on the neurostimulator.
6. Press the Increase or Decrease key to make a change.
7. Move the Stimulation Control switch to amplitude .
8. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
9. Press the Increase key to assess the change. Repeat steps 2 through 9 until the change is acceptable.
10. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.)
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Adjusting the Rate
1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.)
2. Decrease the amplitude to the lowest setting as described on pages 56 - 57.
7
Caution
To avoid unpleasant stimulation, always decrease the amplitude to the lowest setting before adjusting the pulse width or rate of your neurostimulator. After rate or pulse width is set, slowly increase the amplitude to your comfort level.
3. Move the Stimulation Control switch to rate .
Move the Stimulation Control switch to rate.
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1
4. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
5. Press Neurostimulator On to turn on the neurostimulator.
6. Press the Increase or Decrease key to make a change.
7. Move the Stimulation Control switch to amplitude .
8. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
9. Press the Increase key to assess the change. Repeat steps 2 through 9 until the change is acceptable.
10. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.)
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Adjusting the Amplitude
1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.)
2. Move the Stimulation Control switch to amplitude .
Move the Stimulation Control switch to amplitude.
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R61
3. Place the programmer over your neurostimulator. Hold the programmer flat against your skin or clothing so that the keypad is directly over your neurostimulator.
4. Press Neurostimulator On to turn on the neurostimulator.
5. Press the Increase or Decrease key to make a change.
6. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.)
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ACCESSORIES
Wrist Strap and Carrying Case
A wrist strap is packaged with the patient programmer and can be used to help you avoid dropping it. The wrist strap is attached near the battery cover release tab. A carrying case is also enclosed with the programmer. Store the patient programmer in the carrying case to protect it.
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Location of the wrist strap attachment.
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Wrist Strap Attachment
Wrist Strap
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Detachable Antenna
A detachable antenna is available for patients who cannot reach their neurostimulator. The patient programmer can be used to program the neurostimulator as previously described. When connected, the detachable antenna turns off the programmer’s internal antenna.
7
Caution
Do not attach the antenna over your neurostimulator incision using the adhesive discs until the incision heals.
Note: When the detachable antenna is not used, keep the
rubber plug in the antenna connector of the patient programmer. The rubber plug helps keep water out of the programmer.
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To keep the antenna in place, use the adhesive discs supplied with the antenna. The adhesive discs are hypoallergenic. This helps reduce the chance of irritation. If irritation occurs, consult your doctor.
Replace the adhesive discs every day. Before replacing an old disc with a fresh one, clean your skin using an antibacterial soap and dry thoroughly.
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Attaching the Antenna over the Neurostimulator
1. Remove adhesive disc from square sheet.
2. Attach disc to antenna coil. Remove protective covering.
69
Adhesive Disc
Antenna Coil
Adhesive Disc
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Note: The antenna must be properly lined up over the
neurostimulator for programming to occur. The programmer’s internal antenna is disabled when the antenna is properly connected.
4. Press antenna firmly in place.
3. Position antenna over neurostimulator as shown.
70
Neurostimulator
Antenna
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Connecting the Antenna to the Patient Programmer
1. Pull out the rubber plug on the patient programmer to reveal the antenna connector.
Note: The antenna connector is located on the end of the
programmer near the keypad.
2. Insert the antenna’s metal plug into the antenna connector and push the metal plug until it fits securely into place.
Disconnecting the Antenna
1. Grasp the plug and pull it straight out. Do not pull on the cable because this may break the wires.
2. Insert the rubber plug into the antenna connector.
Note: Keep the rubber plug in the antenna connector when
not in use; this helps keep water out of the programmer.
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The detachable antenna and patient programmer.
72
Rubber Plug
Antenna Connector
Antenna
Metal Plug
Keypad
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 72
Caring for the Antenna
If you use the detachable antenna, you should wash it daily with mild soap and water.
Note: Do not allow the metal plug end of the cord to get
wet.
1. Disconnect the antenna from the programmer before cleaning.
2. Wash the antenna with mild soap and water.
3. Rinse the antenna. Make sure no soap remains on it.
4. Dry the antenna with a clean towel immediately after washing.
Note: When not in use, store the antenna in a plastic bag to
protect it from dust.
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Caring for Your Skin
Skin may become irritated from the pressure of the antenna or from an allergic reaction to the adhesive used to hold the antenna in place. Therefore, it is very important to keep the skin in this area clean and dry. Inspect the area every day to see that the skin remains healthy.
7
Caution
If you notice swelling or redness in the area where you place the antenna, contact your doctor before using the antenna again.
Clean the skin over the neurostimulator with an antibacterial soap and change the antenna adhesive discs daily.
If the discs irritate your skin, you may want to wear a soft, snug­fitting undergarment to protect your skin and then tape the antenna to the outside of the undergarment.
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Using Your Control Magnet (Optional)
By briefly applying and then removing the optional control magnet over your neurostimulator, you can turn it on or off. This
feature can be disabled by your doctor, however. If it is disabled, the magnet will not turn the neurostimulator on or off.
Your implant site and the final placement of your neurostimulator can vary from the examples shown in the following instructions. Have your doctor show you how to locate or position the magnet on your neurostimulator so that it is centered as shown in the following figure.
Magnet properly centered over neurostimulator.
75
Neurostimulator
Control Magnet
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 75
To turn the neurostimulator on or off, follow these steps:
Step 1. Grasp the magnet with the flat end away from you.
Step 2. Press the flat end of the magnet directly over and along the
length of the neurostimulator.
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Step 3. Hold the magnet steady for 1 to 2 seconds.
Step 4. Remove the magnet.
If the magnet fails to turn the neurostimulator on or off, repeat steps 3 and 4, holding the magnet against the neurostimulator in a different position. Try a “1 o’clock“ or “4 o’clock“ position.
1 o’clock position 4 o’clock position
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If your doctor has programmed the neurostimulator with the
SoftStart
™
/Stop feature, the magnet will automatically start the
increase or decrease. If the neurostimulator has been programmed with a dosage of stimulation, the magnet will start the dose.
Note: Allow a few seconds for the SoftStart circuit to raise
the amplitude to the point where you can feel it.
If your doctor has programmed the neurostimulator with the cycling feature and you use your magnet (or patient programmer) to turn off the neurostimulator, your therapy will then stop. When you reapply the magnet to turn on the neurostimulator again, your therapy always starts at the beginning of the On cycle.
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79
CARING FOR YOUR PATIENT PROGRAMMER
Battery Cover
When the battery cover is removed, you can replace the battery or access the Stimulation Control switch.
Removing the Battery Cover
1. Hold the programmer with one hand.
2. Lift the battery cover release tab on the end of the programmer. Lift off the cover.
Remove the battery cover.
Release Tab
9900213EN/197877_001/ccs 1/29/01 2:18 PM Page 79
Replacing the Battery Cover
1. Place the center hook on the edge of the cover into the center slot in the programmer.
2. Lower the battery cover.
3. Press down the end of the cover to lock it in place.
Replace the battery cover.
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Identification Label
Your patient programmer comes with an identification label.
1. Fill in the label (name, phone number, etc.) with permanent ink.
2. Peel off the backing and stick the label to the inside of the battery cover.
Note: Do not place the label over the ridges on the battery
cover.
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Placement of the identification label in the battery cover.
82
Inside Battery Cover
Release Tab
Place Label Here
Identification Label
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Checking the Programmer Battery
A 9-volt battery provides the power for the patient programmer. Use an alkaline battery for best performance and economy.
Notes:
• When not using the programmer for more than 4 weeks,
remove the battery to prevent possible damage to the device due to battery leakage.
• Make sure that you always have a fresh 9-volt battery
so that you can turn your neurostimulator on and off or adjust the stimulation settings when necessary.
• Do not use a rechargeable or zinc-air battery. The
programmer is designed to indicate its battery status with an alkaline battery installed; other battery types may not give accurate indications of the programmer’s battery status.
The Programmer Battery light is located on the back of the programmer. It tells you the status of your programmer battery.
9V
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To check the programmer battery: Press any key on the patient programmer keypad. The green Programmer Battery light will respond. Refer to Table 5 for more information about the Programmer Battery light.
Table 5. Programmer Battery light.
When It Means
Green Programmer Battery Programmer battery is OK. light is on for 8 seconds after pressing any key.
Green Programmer Battery light Programmer battery is low. is blinking after pressing Replace with new 9-volt any key. battery.
Green Programmer Battery light Replace with new 9-volt is off after pressing any key. battery.
9V
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Removing the Battery
1. Remove the battery cover. (Refer to “Removing the Battery Cover,” page 79.)
2. Place one finger on the edge of the battery between the Control switches.
3. Lift the battery out of the compartment without using excessive force.
Remove the battery.
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+
SN
Installing the Battery
An alkaline battery is recommended for longer battery life.
1. Remove the battery cover (refer to page 79) and the old battery (refer to page 85), if necessary.
2. Check the battery label for positive [+] and negative [-] contacts. Match them with the [+] and [-] symbols in the battery compartment.
3. Press the battery down fully into the battery compartment without using excessive force.
Notes:
• Do not press any of the programmer’s keys during battery
insertion.
• The programmer performs a self-test when the battery is
inserted. A successful check is indicated by a single flash of the status lights followed by a short beep. If this does not occur, the self-test has failed. Refer to “Troubleshooting,“ page 96.
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4. Replace the battery cover. (Refer to “Replacing the Battery Cover,” page 80.)
Install the battery.
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2.
+
3.
SN
Cleaning and Care
• Your patient programmer is a precision device; handle it with care.
• Do not take apart or tamper with the programmer; this could affect how it works.
• Protect the programmer from sharp blows or physical shocks.
• Clean the outside of the programmer with a slightly damp cloth. Mild household cleaners will not damage the case or labels.
• Your patient programmer is not waterproof. Do not allow moisture to get inside the device.
• If you drop your patient programmer in water, refer to “Troubleshooting,” page 101.
7
Caution
Do not immerse the programmer in liquid. Do not clean it with bleach, nail polish remover, or other similar substances.
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