FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM ed } Synergy FZ MODEL 7435 PATIENT PROGRAMMER User MANUAL Electronic i ——
FCC HX LF57434 7435 EN Manual 9/23/98 4:22 PM Page 2 Device Symbols Keypad Symbols Stimulation Control 3 Flex Genaro On Swish Symbols JTL amplitude @ Pulse Generator OF Jun Rs 27} Decrease JL wise width & Insertions Beeps Control Status tight Symbols Switch Symbols {79 potent translator on @ volume ot ©) poos commies on SY Low Volume cl) High Volume m Prize Torsional A Dime: CONTENTS ABOUT THIS BOOKLET RECOVERING FROM SURGERY. Healing Physical Therapy and Medications Activities WHAT IS PAIN?.
FLACCID: LF57434 7635 EN Manual 9/23/98 4:22 PM Page 4 HOW DOES STIMULATION FEEL? 12 WHAT DOES THE PATIENT PROGRAMMER HOW DOES THE PATIENT PROGRAMMER WORK?. 18 PATIENT PROGRAMMER FEATURE! Keypad... On/Off Key Channel 1 and Channel 2 Keys Battery Over. Removing the Battery Replacing the Battery Cover Control Switches and Battery . Control Switches. Battery Symbols and 3 \taus Lights. Brandenburg —— USING THE PATIENT PROGRAMMER ..
FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page § CARING FOR YOUR PATIENT Cleaning and Care Services TROUBLESHOOTING LIVING WITH YOUR STIMULATION SYSTEM Patient identification Card Her to Call Your Docker Do's and Don'ts. Electromagnet Battery and Device Disposal Medical and Dental Procedure: COMMONLY ASKED QUESTION: SPECIFICATIONS. SPECIAL NOTICE. LIMITED WARRANTY GLOSSARY.
FCC ID: LEAFSTALK 7435 EN Manual 9/23/98 4:22 PM Page 8 4 FCC INFORMATION The following is communications regulation information on the Synergy™ EZ Model 7435 Patient Programmer. FCC 1D: LF57434 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.
FCC ID: LFS7434 7435 EN Manual 9/23/98 4:22 PM Page 2 This booklet provides you with the following: » 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, 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 Angers to common questions » Important terms that appear
7435 EN Manual 9/23/98 4:32 PM Page 4 & — 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 leads and alter your stimulation.
FOC ID: LEST AM 7435 EN Manual 9/23/98 4:22 PM Page § 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 of tiny electrical pulses to the spinal cord. This blocks the pain signal as it travels to the brain.
PCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page § & WHAT DOES YOUR STIMULATION SYSTEM Extension. The extension is a thin wire placed under the skin. LOOK LIKE? It also is covered with a protective coating. The extension A typical stimulation system has five implanted parts: one pulse connects to the pulse generator at one end and to the lead at the other end. generator, two leads, and two extensions. Pulse Generator: The pulse generator is the power source of your system.
FOC ID: CELESTA 7435 BN Manual 9/23/98 4:22 PM Page 10 10 HOW DOES YOUR STIMULATION SYSTEM WORK? After your surgery, your doctor used a small computer (physician programmer) to send stimulation instructions to your pulse generator, These instructions control the stimulation you feel. A programming head connects to the computer. The programming head transfers instructions from the computer to your pulse generator. The instructions are stored in your pulse generator.
FCC ID: LFS7434 7435 EN Manual 9/23/98 4:22 PM Page 12 —B HOW DOES STIMULATION FEEL? Your pulse generator 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 pulse generator is turned on, the tingling slowly increases until it levels off.
FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 14 14 As your spine moves, you may sense an increase or decrease in the stimulation. It may seem as though the pulse generator 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 pulse generator have not changed.
FOC ID: CELESTA 7435 EN Manual 9/23/98 4:72 BM Page 15 ~b WHAT DOES THE PATIENT PROGRAMMER DO? Your programmer is easy to use. You can use it tor Use the patient programmer with only your implanted pulse « Turn the pulse generator on or off. generator. DO NOT use the programmer on other devices (such Adjust the stimulation of your pulse generator. as, a cardiac pacemaker). Check the battery status of the pulse generator and the . EEE at .
FCC ID: LFS7434 7435 EN Manual 9/23/98 4:22 PM Page 18 HOW DOES THE PATIENT PROGRAMMER WORK? The patient programmer sends signals to your pulse generator. These signals tell the pulse generator to turn on or off or to change stimulation. The pulse generator also sends signals to the patient programmer. Signals from the pulse generator confirm changes you Lave made. Signals also tell you the status of the pulse generator battery.
FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM 20 Keypad The keypad has 6 keys: pulse 8 and Increase t and Decrease + keys for C| 2. Note: Pressing any key on the p no keys are pressed in 8 seconds, the programmer will turn off. Tums pulse generator on increase and Decrease keys = fer Chan! 1 page 20 The keypad. ~~ generator On @ and Off @ keys, channel 1 and Channel programmer turns it on.
FCC ID: LFS434 7435 EN Manual 8/23/98 4:22 ¥M Page 22 22 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. 9. Lift the battery cover release tab on the end of the programmer. Lift off the cover. Release tsb Remove the ratifier cover. —4— Replacing the Battery Cover 1. Place the center hook on the edge of the cover inch the center slot in the programmer. 2.
FCC ID: LF57434 7435 EN Manual ©/23/98 4:22 PM page 24 —— Control Switches and Battery The Control switches and battery are located beneath the battery cover. Stimulation Contra) Switch (Rats fz selected) (ganglia) Seeger Control Switch : (High volume is selected} {ane nn Miltiades Baku Puss : Wish CLM Low ih Battery Control switches and battery. 24 Control Switches Stimulation Control Switch You can adjust three settings with the Stimulation Control switch: amplitude, rate, and pulse width.
FCC 1D: LF57434 7436 EN Manual 9/23/98 4:32 PM Page 26 Beeper Control Switch The programmer beeps each time a change is received by your pulse generator. Turn the beeper off & or set the volume to low < or high 9 with the Beeper Control switch. 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 pulse generator.
FCC ID: LFS7434 7435 BN Manual 9/23/98 4:22 PM Page 28 28 Symbols and Status Lights The back of your programmer displays symbols and status lights. These will help you during a programming session. Symbols A target symbol helps you center your programmer over the pulse generator. An antenna symbol directs you to the antenna connector. An optional, detachable antenna can be plugged in here.
5 FLACCID: LF57434 7435 EN Manual 9/23/98 4:22 PH Page 30 USING THE PATIENT PROGRAMMER This section is organized as follows: * Placing the Programmer Over the Pulse Generator » Checking the Pulse Generator Battery + ‘Turning the Pulse Generator On and Off «Adjusting Your Stimulation Placing the Programmer Over the Pulse Generator Place the programmer over your pulse generator.
FCC ID: CELESTA 7435 EN Manual 9/23/98 4:22 PM Page Checking the Pulse Generator Battery The Pulse Generator Battery light on the back of the programmer tells you the status of your pulse generator battery. To check the pulse generator battery: 1. Place the programmer over Our pulse generator, Use the target 8 on the back of the programmer to help you center the programmer over your pulse generator. 2. If your pulse generator is off, press the off key. If your pulse aerator is on, press the on key.
1D: LE$T434 FCC 7435 EN Manual 9/23/98 4:22 PM Page 34 & @ Turing the Pulse Generator On and Off Turn your pulse generator on when: * You require pain relief, or * You want to adjust the amplitude, rate, or pulse width.
FCC 1D: LESTER 7435 BN Manual 9/23/96 4:22 PM Page 36 To turn the peels generator on: 1. Place the programmer over your pulse generator, Use the target symbol on the back of the programmer to help you center the programmer over your pulse generator. Place the programmer over the puss generator. 2. Press the Pulse Generator On key and hold the programmer over the pulse generator for 1 second. If the beeper is on, you should hear one beep to confirm that a change has occurred.
7435 EN Manual 9/23/98 4:22 PM Page 38 To turn the pulse generator off: 1. Place the programmer over your pulse generator. Use the target symbol on the back of the programmer to help you center the programmer over your pulse generator. Pulse — Generator Press the Pulse Generator Off key. = Internal . Ants 3. Check that the yellow Pulse Generator Off light on the back of 2 the pro gr “2 Place the programmer over the pulse generator.
FCC ID: LFST434 7435 EN Manual 9/23/98 4:32 PM Page 40 Tabla 3. Pulse Narrator On @ ang Off @ lights. {When Mt Means ™ “The green Pulse Generator On light is lit | Pulse generator is on. for 8 seconds after pressing any key. The yellow Pulse Generator Off light is it | Pulse generator is off. for 8 seconds after pressing any key. Nether False Generator On or Off The programmer does not know ligate is lil after pressing any key. if the pulse generator is on of off L Refer to “Troubleshooting” peg 74.
FCC ID: LF37434 7435 EN Manual §/23/98 4:22 PM Page 42 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.
57434 PCP: LE 7435 EN Manual 44 9/21/98 4:22 PM Page 44 Channel 1 and Channel 2 Increase t and Decrease + keys cannot be used at the same time. Both channels always have the same rate. Either set of channel keys will adjust the rate. The Channel 1 Increase * and Decrease + keys adjust the amplitude or pulse width for Channel 1. The Channel 2 Increase t and Decrease + keys adjust the amplitude or pulse width for Channel 2. The pulse generator must be on to increase amplitude, rate, and pulse width.
FCC ID: LF57434 7435 EN Manual 9/23/98 4:32 PM Page 46 Decreasing the Amplitudes to the Lowest Setting Always decrease the amplitude for each channel to the lowest setting before adjusting pulse width and rate or turning your pulse generator Off. 1. Remove the battery cover. 2. Move the Beeper Control switch to low © or high @. 3. Move the Stimulation Control switch to amplitude ML. Boone | [ET Moss ihe Stimulation Control switch to amplitude. 4 4. 5, Place the programmer over Our pulse generator.
FCC ID: LFS7434 7435 EN Manual 48 9/23/98 4:22 PM Page 48 Adjusting the Pulse Width 1. Remove the battery cover. 2. Decrease the amplitude settings as described on pages avoid unpleasant stimulation, always decrease the amplitude to the Northwest setting before adjusting the pulse width or rate of your pulse generator. Afire rate or pulse width is set, slowly increase the amplitude to your highest comfort level. Move the Stimulation Control switch ta pulse width. 3.
+ FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 50 Adjusting the Rate 1. Remove the battery cover. 2. Decrease the amplitude of both channels to the lowest settings as described on pages avoid unpleasant stimulation, always decrease the amplitude to the lowest setting before adjusting the pulse width or rate of your pulse generator. After rate or pulse width is set, slowly increase the amplitude to your highest comfort level. Mace tho Stimulation Control switch to ata. . Press Pulse Generator On .
7435 BN Manual $/23/98 4:22 PM Page 52 Adjusting the Amplitude 1. Remove the battery cover. 2. Move the Stimulation Control switch to amplitude JIL. Move the Stimulation Control switch to amplitude. FCC 1D: LF57434 52 Place the programmer target symbol on the back of the programmer to help you center the programmer over your pulse generator. Press Pulse Generator On 3 to turn on the pulse generator. Press the Increase tor Decrease + key under the desired channel to make a change.
FCC ID: CELESTA 7435 EN Manual 9/23/98 4:22 PM Page 54 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. Meg £2] West Strap ~~ Attachment Location of the wrist strap attachment.
FCC ID: LF57434 7439 EN Manual 9/23/98 4:22 PM Page 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. Detachable Antenna A detachable antenna is available for patients who cannot reach their pulse generator. When connected, the detachable antenna turns off the programmers internal antenna. —— Replace the adhesive dies very dy.
FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 58 Attaching the Antenna Over ths Pulse Generator Adhesive Oise — i. Remove adhesive disc from square sheet. 2. Attach disc to antenna coil. Remove protective covering, Pulse Generator Antenna 3. Center antenna over 4. Press antenna firmly in pulse generator. place. Note: The antenna must be properly centered over the pulse generator for programming to occur.
FOC TD: LFS7434 7435 EN Manual 9/21/98 4:22 PM Page 60 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 clicks into place. Disseminating the Antenna 1. Grasp the plug and pull it straight out.
we FLACCID: LF37434 7435 BN Manual 9/23/98 4:42 PM Page 62 Caring for the Antenna 1 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.
PCC ID: LEAFSTALK i435 BN Mammal 798 4:22 PM Page 64 CARING FOR YOUR PATIENT PROGRAMMER Identification Label Your patient programmer comes with an identification label. 1. ri 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. : : en train Labs inside Battery Aver Placement of the identification label in the battery cover.
FCC ID: LF37434 | 7435 EN Manual 9/23/98 4:22 PM Page 66 f= @ Checking the Programmer Battery The Programmer Battery light is located on the back of the programmer. It tells you the status of your programmer battery. 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.
FCC 1: LF57434 7435 EN Manual 9/21/98 4:22 PM Page 68 Removing the Battery 1. 2. 3 Remove the battery cover. Place one finger on the edge of the battery between the Control switches. Lift the battery out of the compartment without using excessive force. Remove the battery.
FCC ID: LF57434 | 7435 EN Manual 9/23/98 4:22 PM Page 70 by 70 Installing the Battery An alkaline battery is recommended for longer battery life. Do riot use a mercury or zinc-air battery. 1. Check the battery label for positive and negative {1 contacts. Match them with the and symbols in the battery compartment. 2. Press the battery down fully into the battery compartment without using excessive force. Note: The programmer performs a self-test when the battery is inserted.
FCC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 72 72 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.
FCO ID; LES7434 7435 EN Manual 9/23/98 4:22 PM Age 74 $b 74 Service The Synergy EZ Patient Programmer has been designed and tested to provide long, trouble-free service: If repair or service is needed, call Electronic at 1-800-328-0810. To register the programmer for service covered by the warranty, complete and mail the warranty registration card. It is inserted in this manual. The serial number is, located on a label within the battery compartment. It identifies each Synergy EZ Patient Programmer.
7434 FCC IDL LFS 7435 EN Manual 9/23/98 4:22 PM Page 76 TROUBLESHOOTING This section will help you solve problems or identify when to call your doctor. Problems are described in the left column. The blue text in the right column lists possible causes of the problem (Causes); the bold text in the right column describes how to correct the problem (Action). Note: If your problem is not solved after several attempts, or if your problem is not described here, contact your doctor.
7435 EN Manual 9/23/98 4:22 PM Page 78 db Problem Causes and Action Problem Causes and Action The Programmer Battery Programmer or detachable antenna is not correctly You want to check If the Pulse Generator is off, push the OIf key. The light turns on, but Nome centered over pulse generator. your pulse generator yellow Pulse Generator Off light should be fit. of the Pulse Generator Reposition programmer or antenna and try again. without changing the §€ the pulse generator is on, push the On key.
FCC ID LF57434 7435 EN Manual Problem The Pulse Generator lights are off when you press any key. The Status lights do nat flask and the beeper does not beep when a fresh battery is installed. 9/23/98 4:22 PM Page 80 —— Casals and Action Treble ‘The programmer or detachable antenna is not centered The beeper does nat correctly ver the pulse generosity. sound. Only the Reposition the programmer or antenna and try again. Programmer Battery light is on.
POC 1D: CELESTA 7935 EN Manual 9/23/98 4:22 PM Page 82 Probity You feel a programming change after preaching & key, but the beeper didn't beep and fhe Pulse Generator On or Off lights del not light. Causes snd Action The programmer was too far away front the pulse generator. The pulse generator night have received the signal to change buf did not TEFL the programmer. what it did.
vei: LEST 7435 EN Manual Presenter Your pulse generator will not tur on. 9/23/98 4:22 PM Page 84 Ga ques 3nd Action “hie programmer or detachable antenna is not centered discreetly aver the pulse generator. Reposition the programmer or antenna and iry again. The programmer was removed from the pulse generator taa soon. Hold the programmer closer to your pulse generator, line up the target symbol, and try again. Hold the programmer over the pulse generator for at least 1 second.
~ PCP: LES7434 7435 EN Manual 9/23/98 4:22 PM page 86 LIVING WITH YOUR STIMULATION SYSTEM Patient Identification Card When you leave the hospital, your doctor will give you an identification card. This card supplies basic information about your pulse generator and identifies your doctor in the event of an accident. Your identification card allows you to bypass security arches or wands such as those used in airports. Carry this card with you at all times.
FCC ID: L¥57434 7435 EN Manual 9/23/98 4:22 PM Page 88 When to Call Your Doctor Your doctor will schedule follow-up visits every 6 months. Your doctor will check your pulse generator and make sure you are receiving the most appropriate treatment, However, you should contact your doctor if any of the following events occur: * You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery. * Your pulse generator is not working properly. * You are not getting enough pain relief.
FCC ID: LFST434 7435 EN Manual 9/23/98 4:22 PM Age 90 Do’s and Don'ts By following the guidelines listed below, you can ensure that your patient programmer will function properly. Do: * Keep your patient programmer out of the reach of children, * Use your patient programmer only as explained to you by your doctor or as discussed in this manual. * Handle your patient programmer with care. It is a sensitive device that can be damaged by rough handling.
FCC I: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 92 —4— Electromagnetic interference (EMI) Strong electrical fields, such as those produced by radio towers or some industrial equipment, can affect the function of your pulse generator. This can cause uncomfortable stimulation (a “jolt” or “shock”). This problem is called electromagnetic interference, or EMI Most household appliances and office equipment do not produce interference strong enough to affect your pulse generator.
~r FCC ID: LF37434 7435 EN Manual 9/23/98 4:22 PM Page 94 You can normally operate the following household items and office equipment: Microwave ovens Appliances such ag washers, Televisions, AM/FM radios, dryers, garage door openers, VCR, cellular phones, etc. staves: Tabletop appliances such as . , toasters, blenders, electric can pie arc blankets and heating openers, and food processors \ } Personal computers, electric Hand-held items such as hair : ; dryers, electric shavers, and typewriters, capers, an
FLACCID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 96 If you suspect that an electric or magnetic device is interfering with your pulse generator, move away from the device or, if possible, turn the device off. Then use the patient programmer to turn your pulse generator on or off. Use care when approaching security arches (such as those found in airports, libraries, and some department stores) a these devices can case inappropriate or additional stimulation if you pass through them.
FLACCID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 98 98 Medical and Dental Procedures With proper precautions, most medical procedures are unlikely to interfere with your pulse generator. Tell any medical staff that you have an implanted stimulation system. Decrease your amplitude to its lowest setting and turn the pulse generator off before all medical and dental procedures.
7435 BN Manual 9/23/98 4:22 IM Page 100 COMMONLY ASKED QUESTIONS What does stimulation feel like? The electrical pulses delivered by your pulse generator usually feels like tingling in the area of your pain. Con I turn my pulse generator on or off? Yes. You can use your patient programmer to turn your pulse generator on and off. Will I be able to adjust the stimulation? Yes. You can use your patient programmer to fine tune the amplitude, pulse width, and rate.
FCC ID: LE57434 7435 EN Manual 9/21/98 4:32 PM Page 102 Can the battery be recharged? No. Haw is the pulse generator battery replaced? The entire pulse generator must be surgically replaced because the pulse generator’s battery is sealed within the device. This replacement procedure usually does not include replacement of the lead(s) or extensions). How large is the pulse generator? The pulse generator is oval and approximately 3 inches long, 2.4 inches wide, and 0.5 inches thick.
FCC ID: 1F57434 7435 EN Manual $/23/98 4:22 PM Page 104 What should 1 do if the stimulation changes ar becomes painful? Use your patient programmer to turn your pulse generator off and contact your doctor. What does it men if I can feel stimulation only sometimes? programmed turn on and off at regular intervals.
~ FLACCID: LF57434 7435 EN Manual 9/23/98 4:12 PM Page 106 How often will Unwoven to replace the battery in my patient programmer? Battery life depends on how often the programmer is used. Typically, a patient can expect at least 3 months of use from a new battery. Always keep a fresh battery available.
FCC: LF57434 7435 BN Manual 9/23/98 4:22 ¥M Page 108 SPECIAL NOTICE ‘The Medtronic®Synergy™ EZ™ Patient Programmer (the “Programmer”) Model 7435 is designed to program the adjustable parameters of the Medtronic® Synergy™ Implantable Pulse Generator (IPG) Model 7427, The programming functions of the Programmer are not compatible with any other devices. For information regarding difficulties which may be encountered using the Programmer, consult the other portions of this manual.
PCP: LFS7434 7435 EN Manual 9/23/38 4:22 PM Page 110 —— (2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement Equipment. B. To qualify for Limited Warranty set forth in Section A(1), the following conditions must be met: (1) The Equipment must be returned to Electronic within thirty (30) days after discovery of the defect, (Electronic may, at its option, repair the Equipment on site).
FOC WD: CELESTA 2 7435 EM Manual 2/23/98 4:22 PM Page 112 & {3) The exclusions and limitations set out above are not GLOSSARY intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any Amplitude—The amount or “volume” (strength or intensity) of part or term of this Limited Warranty 3s held to be illegal, stimulation required to mask your pain. This setting is adjusted unenforceable or in conflict with applicable law by a court most often by patients.
LES7434 PCP: 7435 EN Manual 9/21/98 4:22 TM Page 114 114 Extension—A thin wire that connects the pulse generator to the lead. Talus Footlights status lights are located on the back of the patient programmer. They tell you whether the pulse generator is On or Off, the pulse generator battery status, and the patient programmer battery status. Lead-—A wire with small metal electrodes near the tip that is implanted near the nerves to be stimulated.
FOC ID: LF57434 7435 EN Manual 9/23/98 4:22 PM Page 116 146 Stimulation Control Switch—Located under the battery cover. You can adjust three settings with the stimulation control switch: amplitude, rate, and pulse width. Stimulation Settings—The settings that can be adjusted to affect the stimulation you feel. These settings are amplitude, pulse width, and rate. Stimulation implanted system that delivers tiny electrical pulses to the area in your body where your pain signals will be blocked.
FOC HD: F57434 7435 EN Manual 9/23/98 4:22 PM Page 118 IMPORTANT: Please detach, fil out, and mail this card fo register your programmer. i i {The serial number is located under the §-volt battery.) Synergy™ EZ™ Pat lent Programmer Mode! 7435 Warranty Registration Card lariat Number: [EFFIE T TT TTT) purpose bate: Cl (.
FCC ID: LEAFSTALK 743% EN Manual 8/23/98 4:22 PM page 120 & Electronic 8 Meg ironic Neurological 800 53rd Avenue NE poos, MN 55421-9611 1612) 574-5000 FAX: (612) 514.
ch LOCI: LFS7434 manual 9728/98 2:17 PM Page 2 Device Symbols Keypad Symbols Stimulation Control 5 Pulse Gomorrah Un Switch Symbols J Amplitude Puss Overstock 8 = JUL Ras [3 mower EL pus wie ® Inc reuse Beeper Control Status Light Symbols Switch Symbols {9 en Gossamer on @ vom on (Gy Pens ssa on oD Low vacuums — {@ Vise Conversion OD gh vem -B-9 sam CONTENTS FCC INFORMATION! INTRODUCTION... ABOUT THIS GUIDE.
FCC ID: LF57434 manual 5/28/98 2:17 PM Page 4 Stimulation Central Switch. USING THE THERAPY CONTROLLER Placing the Controller Over the Pulse Generator Checking the Pulse Generator Battery Turning the Pulse Generator Oa and Wrist Strap and Carrying Case. CARING FOR THE THERAPY CONTROLLER 30 identification Label. Checking the Therapy TROUBLESHOOTING. ADDITIONAL FEATURE Beeper Control Switch.
FCC 1D: LF37434 manual 8728/98 2:17 PM Page 6 EN la] designed program parameters of the Medtronic® Kinetra™ Model 7428 simulator (or “pulse generator”). Do Not attempt to use the programmer on another device (for example, a cardiac pacemaker). Radio signals from the therapy controller may interfere with the performance of other implantable devices. FCC INFORMATION The following is communications regulation information on the Synergy™ EZ Model 7435 Patient Programmer.
FCC ID: LF57434 manual 9/28/98 2:17 PM Page 2 INTRODUCTION The Access™ Model 7436 Therapy Controller is a portable, handheld device designed for use with the Kinetra™ Model 7428 Overstimulate. It may be used by patients or their doctors. ‘The therapy controller can be used by patients or doctors to: . Turn the pulse generator on or off. Check the status of the pulse generator and therapy controller batteries. Confirm that the pulse generator has received information from the therapy controller.
SCC ID: CELESTA ¥CC + manual 9/28/98 1:41 PM Page 4 COMMON USE AND CARE OF THE ACCESS” THERAPY CONTROLLER Therapy Controller Function An antenna is located beneath the keypad inside the therapy controller. When the therapy controller is held over an implanted pulse generator and the keys are pressed, the internal antenna sends a coded radio signal to the pulse generator.
FCC 1D: LF57434 manual 9/28/98 1:41 PM Page 6 Therapy Controller Features This section describes the features of the therapy controller. Keypad Battery Cover The Access™ Therapy Controvertible. Keypad The keypad has 6 keys: Pulse Generator On @ and Off @ keys, and Increase and Decrease 4 keys for Channel 1 and Channel 2. Note: Pressing any key on the therapy controller automatically turns keys are pressed in 8 seconds, the therapy controller automatically turns off.
= FCC ID: LE57434 + manual Y/A8/98 1:41 PM Page 8 O Off Keys The On and Off @ keys turn the pulse generator on and off. Channel 1 and Channel 2 Keys The channel keys are active only for some patients, depending on their needs. Actors should inform patients if they have use of these keys, If these keys ate inactive, nothing will happen if they are accidentally pressed; however, the programmer will emit three beeps.
FCC ID: LFS57434 + manual 4/28/98 1:43 PM Page 10 Replacing the Battery Cover 1 Place the center hook on the edge of the cover into the center slat in the controller as shown below. . Lower the battery cover. Press down the end of the cover to lock it in place, Replace the battery cover. ge Battery A rectangular 9-volt battery provides the power for the therapy controller. You may use an alkaline or carbon-zinc battery. An alkaline battery is recommended for longer battery life.
FCC ID: LE57434 manual 2 9728798 1:41 PM Page 12 Battery Battery and Control switches. Blooper Conical Switch Stimulation Control Switch For many patients, the Stimulation Control switch has been turned off by their doctor. Patients should not be alarmed if the switch is accidentally moved; nothing will happen. Some patients, however, will have one control—the amplitude {stimulation intensity }—turned on.
LF57434 FCC ID: ¥ manual /UB/YE 1:41 PM Page 14 Bumper Control Switch The Beeper Control switch is set to high @ volume when shipped. When using the therapy controller, the beeps can be used as a guide (see Table 1), Table 1. Busier description. 1 you hear 1h means A One beep You have the On/Off or Increase/ Decrease (if applicable) key and the change was successfully received by the pulse generator.
FCC ID; LF57434 manual 9/28/98 1:41 PH Page 16 Avicenna Symbol {nt applicable) Grow Guise Generate ong Res Pulse Separator Eatery Light Grass Therapy Controller Cattery Light Ue Ce Target Symbol Center this symbol over your pulse generator Lelia Pulse Generator “08” Light Symbols and Status lights on the back of the therapy controller.
LE57434 FCC ID: manual Note: The center of the controller target symbol is in line 9/28/98 1:41 PM Page 18 with the center of the keypad (center of the internal antenna). | AA Place the target symbol over the pulse generator. —— w-® Checking the Pulse Generator Battery The Pulse Generator Battery light on the back of the controller displays the status of the pulse generator battery. To check the pulse generator battery: 1.
a 4 t+ FCC ID: LF5743; manual 9/28/98 1:41 PM Page 20 Note: Move indoors or into the shade if sunlight blocks your view of the controller lights. Table 2, Puss Generator Eatery B00 ~~ @ guts, {When Jt Means 1 Green Pulse Generator Battery light is on for § seconds after pressing. any key. Pulse generator battery is good. Green Pulse Generator Battery light is blinking for 8 seconds after pressing any key. ‘The pulse generator battery is Tow.
1 FCC ID: LF57434 manual 9/28/98 1:41 PM Page 22 . Press the Pulse Generator On key and hold the controller over the pulse generator for 1 second. The controller should beep once to confirm that a change has occurred. Truss the Pulses Generator On key. 3. Check that the green Pulse Generator On light on the back of the controller is lit; this indicates that the pulse generator was successfully turned on (Table 3). This fight stays on for 8 seconds after you release the key.
manual 3/28/98 1:41 PM Page 24 A FCC ID: LF57434 24 Crass the Pulse Generator OF key. 3. Check that the yellow Pulse Generator Off light on the back of the controller is kit; this indicates that the pulse generator was successfully turned off (refer to Table 3). This light stays on for 8 seconds after you release the key. Note: Move indoors or into the shade if sunlight blocks your view of the controller lights. Table 3. Pulse Generator On 03 ang of KD heights.
CID: LF57434 FC manual 9/28/98 1:41 PM Page 26 Adjusting the Amplitude (stimulation intensity) Notes: ¢ The amplitude can be adjusted using the therapy controller only if this function was turned on with the physician programmer. Patients should confirm this with their doctor. ¢ The Channel 1 Increase t and Decrease + keys adjust the amplitude for one lead; the Channel 2 Increase t and Decrease § keys adjust the amplitude for the other lead.
manual 9/28/98 1:41 PM Page 28 ah ACCESSORIES Wrist Strap and Carrying Case A wrist strap is packaged with the therapy controller and can be used to help you avoid dropping it. The wrist strap may be attached to the controller on the loop near the battery cover release tab. A carrying case is also enclosed with the controller. Store the therapy controller in the carrying case to protect it. f FLACCID: LF57434 28 Wrist 7 Sap Location of the wrist strap attachment.
FOC ID: L¥FS7434 manual 9/28/98 1:41 PM page 30 CARING FOR THE THERAPY CONTROLLER Identification Blahs The therapy controller comes with an identification label. phone number, etc.) with permanent ink. 2. Peel off the backing and stick the label to the underside of the battery cover, Note: Do not place the identification label over the ridges on the battery cover.
\ A FLACCID: LFs7434 manual 9/28/98 1:41 PM Page 32 A= ® Checking the Therapy Controller Battery The Therapy Controller Battery light on the back of the controller tells you the status of the controller battery. To check the controller battery: Press any key on the therapy controller keypad; the green Therapy Controller Battery light will respond. Refer to Table 4 for more information about the Therapy Controller Battery light.
manual 9728/98 1:41 PM Page )4 Engraving the Battery 1. Remove the battery cover. 2. Place one finger on the edge of the battery near the keypad (between the control switches). 3. Lift the battery out of the compartment without using excessive force. ch FCC ID: LF57434 Remove the hatter.
Ah FCC ID; LFS7434 manual 3/46/98 Dill IM Page 36 Installing the Battery An alkaline battery is recommended for longer battery life. EE Do not use a mercury or zinc-air battery. 1. Match the and symbols on the battery with the and symbols in the battery compartment. Insert the battery into the compartment, symbol end first. 2. Press the battery down fully into the battery compartment without using excessive force, Note: The controller performs a self-test when the battery is inserted.
hy FCC ID: IFS7434 manual 8/28/98 1:41 PM Page 38 Cleaning and Care The therapy controller is a precision instrument and must be handled with care. Do not take apart or tamper with the controller; this could affect its performance. Protect the controller from sharp blows or physical shocks. Clean the outside of the controller with a slightly damp cloth. Mild household cleaners will not damage the case or labels. The therapy controller is not waterproof.
FCC ID: LE57434 v manual 9/28/98 1:41 PM Page 40 The Access Therapy Controller has been designed and tested to provide long, trouble-free service. If repair or service is needed, call Electronic at 1-800-328-0810. To register the programmer for service covered by the warranty, complete and mail the warranty registration card. It is inserted in this manual. The serial number is, located on a label within the battery compartment. Jt identifies each Access Therapy Controller.
FCC ID: LF57434 manual 9/28/98 1:41 pM Prettify The controller battery Tight turns on, but none of the pulse generator lights ase on. The pulse generator battery light is blinking, ar it has been blinking and is now off. You want to check the pulse generator without changing the setting. Page 42 Explanation and Acton Controller not centerfold over pulse generator, Reposition controller and try again. The pulse generator battery is low or depleted.
A CID: LF57434 FC manual 9/26/98 1:41 PM Prod an The beeper does rot sound. Only the controller battery light is On. Page 44 < Explanation and Action Problem The beeper is not The pulse generator Set the beeper control witch to low ar high and listen to will not turn on, be sure it is working. The controller ls not positioned coyer over the Tulsa generator. Reposition the controller and try again. Phe controller was removed farm the pulse generator ton soon.
FLACCID: LF57434 manual 9/28/98 1:41 PM Page 46 & controller, The controller falls anti water. The controller falls off a cabinet or table. 46 Explanation and Action Dry it with a towel. roller from water, th a towel dampened with clean tap water. e battery cover and battery. 4. Dry battery compartment with a towel. S. Allow battery compartment to dry ai room temperature for as long as possible {24 hours recommended), 6, Replace battery. 2.
FCC ID: LF57434 ¥ 4 19/28/99 1:41 PH Page 48 ADDITIONAL FEATURES This section discusses the additional features available with the therapy controller. Control Switches This section describes the Control switches and the additional stimulation settings that can be adjusted within the physician-set limits. Limits are programmed into the pulse generator with the physician programmer.
FLACCID: LF57434 manual 8/28/98 1:41 PM Page 50 Stimulation Control Switch Three settings can be adjusted with the Stimulation Control switch: amplitude, rate, and pulse width, Each setting is identified with colors and symbols as shown below. ‘The amount or “volume™ (strength or intensity) of stimulation. (om mommies oo] The length or duration of the electrical pulse. Nate: The Increase t and Decrease § keys on your keypad adjust the selected stimulation control.
FLACCID: LF57433 manual y/28/98 1:41 pM Page 52 Adjusting the Stimulation Programming Information The following tips will be helpful when using the therapy controller. * Always set the pulse generator to the lowest possible settings that provide adequate symptom relief. The higher the settings, the faster the pulse generator battery will wear out. When the battery wears out, the pulse generator must be surgically replaced, so you want to make it last as long as possible.
manual 9/28/98 1:41 PM Page 54 & Adjusting the Amplitude 3. Place the controller over the pulse generator. Use the target 1. Remove the battery compartment cover. symbol on the back of the controller to help you position the 2. Move the Stimulation Control switch to amplitude. controller over the pulse generator. 4. Press Pulse Generator On 8 key to turn on the pulse generator. 5. Press the Increase t or the Decrease | key under the desired channel to make a change. T 6.
manual 9/28/98 1:41 PM Page 56 4 Adjusting the Pulse Width 3. Place the controller over the pulse generator. Use the target 1. Remove the battery compartment cover. symbol on the back of the controller to help you position the 2. Move the Stimulation Control switch to pulse width. controller over the pulse generator. 4. Press Pulse Generator On 8 key to tum on the pulse generator. 5. Press the Increase 1 or the Decrease + key under desired channel to make a change. 6.
a4 in: LF57434 FCC manual 9s # 1:41 ¥M Page S58 Ad lusting the Rate 1. Remove the battery compartment cover. 2. Move the Stimulation Control switch to rate. Move the Stimulation Central switch to rate. Place the controller over the pulse generator. Use the target symbol on the back of the controller to help you position the controller over the pulse generator. Press Pulse Generator On & key to turn on the pulse generator. Press the Increase t or the Decrease + key under either channel to make a change.
CHD: LFS7434 FC manual 8/28/98 1:41 PM Page 60 GLOSSARY intensity of stimulation. Beeper Control under the battery cover. It lets you turn the beeper off or set the volume to low or high. Physician Programmer—The small computer used to send stimulation instructions ta the pulse generator. Status Lights—Four Status lights are located on the back of the therapy controller. They tell you whether the pulse generator is on or off, the pulse generator battery status, and the therapy controller battery status.
FLACCID; LES7434 manual Y/2E/9% 1:41 PM Page 62 SPECIFICATIONS Power Source: 9-volt alkaline battery (type 6LR61 or 6F22E) Battery Life: 3 months (average) Operating Temperature: +9 10 +40°C (+49 to +110°F) Storage Temperature: “4010 465°C (-40 to +150°F) Relative Humidity: 10% to 85% Atmospheric Pressure: 500 hPa to 1060 hPa (14,8 in. Hg to 31,3 in.
FOC ID: LESTER Tv manual 9/28/98 1:41 PM Page 64 MEDTRONIC® NEUROLOGICAL ACCESS™ MODEL 7436 THERAPY CONTROLLER LIMITED WARRANTY (U.S. Customers Only) A.
FLACCID: LF57434 manual 9/28/98 1:41 PM Page 66 —— ON ANY DEFECT, FAILURE OR MALFUNCTION OF (3) The exclusions and limitations set aut above are not THE EQUIPMENT, WHETHER THE CLAIM IS BASED intended to, and should not be construed WARRANTY, CONTRACT, TORT OR OTHERWISE. contravene mandatory provisions of applicable law.
i FCC ID: LF57434 manual 9/28/98 1:41 PM Page NECESSARY } FUSED | IN THE ! UNFED STATES. BUSINESS REPLY MAIL| i Fr cogs RL molar, ry crn POSTAGE WILL BE PAID BY ADDRESSEE ELECTRONIC NEUROLOGICAL — ' IMPLANT REGISTRATION SERVICE — PO BOX 1250 MINNEAPOLIS MN 55440.
RY FCC Ip: LF37434 manual 9/28/98 1:41 tM Page 70 gr IMPORTANT: Please detach, fil out, and mail his card to register your programmer. (The series number is located trader the 9-volt battery.
[manual 9/26/99 1:41 ou page 72 by Electronic FCC ID: LF57434 Mentions Neurological 800 53d Avenue NE Minneapolis, MN 554219811 Printed in Tha USA
70462388/Card/ces 9/23/98 4:26 PM Page 1 7 . Synergy™ EZ™ Patient Programmer To turn the pulse generator on or off: 1 Position the programmer over your pulse generator. FCC ID: LPS7434 Internal B Quick Programming Guide To turn the pulse generator on. a) Press the Pulse Generator On key: Listen for the confirmation beep. light is lit. This light stays on for 8 seconds after you release the key. To turn the pulse generator off: a) Press the Pulse Generator Off key. Listen for the confirmation beep.
H Remove the battery compartment cover. Select the stimulation setting: : amplitude Li ) rate {nL ), or pulse width (SL). B Position the programmer over your pulse generator. pA FCC: LFST43 Press the Pulse Generator On key. Listen for the confirmation beep. B Electronic 8 9704623EE/Card/ccs 9/23/98 4:26 PM Page i To adjust amplitude, rate, or pulse width: B Press the Increase (1) of the Decrease ( ) key under desired channel to make a change. You N should hear one beep for each change.
i 9705393ER/ Card, 28/98 5:40 PMP, 9705393EE/Card/ces 9/28/98 5 age P FLACCID: LF57434 3 I ! Access™ Therapy Controller Quick Programming Guide To turn the pulse generator on or off; A To turn the pulse generator on: Position the controller over your 2 One Larsen enumerator pulse generator. confirmation beep. Battery Compartment Over b) Check that the green Pulse Generator On light is lit, This light stays on for 8 seconds after you release the key.
9705393EE/Card/cos 9/28/98 5:40 PM Page *$ To adjust amplitude: Sen Position the controller over your pulse generator. On key. Listen for the confirmation beep. Press the Increase (1) or the Decrease (§ ) key under desired channel to make a change. You should hear one beep for each change. FLACCID: LF57434 If the Therapy Controller beeps: SOUND ACTION one beep You have pressed the On/Off or Increase/ Decrease key and the change was received by the pulse generator.