SynchroMed Activator, Model 8831 manual

 

200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1 FCC ID: LF58831 You and Your SynchroMed Activator Model 8831 Activator for Your SynchroMed or SynchroMed EL Implantable Drug Pump Patient Manual Caution: Investigational Device. Limited by federal law (U.S.A.) to investigational use. Rx Only File No. NC1GXXXX01, Page AX of AXX 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 3 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 55-square-meter 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 worlds 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 SynchroMed Activator, is one small way we try to help. Welcome to the Medtronic family. We wish you well. 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4 Status Light Symbols Explanation of Symbols Successful Dose Activation Incomplete Communication Interval Lockout 9V Activator Battery Status Miscellaneous Symbols y w IEC 60601-1, Type BF Equipment Attention: See accompanying documents w Caution: This device contains a strong magnet. Proximity to recording tape and disks should be avoided. Medtronic, SynchroMed, and SynchroMed EL, are registered trademarks of Medtronic, Inc. Refer to the instructional label on the SynchroMed Activator for all applicable approvals. 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 5 CONTENTS FCC INFORMATION........................................................ 1 INTRODUCTION .............................................................. 2 SYNCHROMED ACTIVATOR DESCRIPTION.......... 4 SYNCHROMED ACTIVATOR COMPONENTS AND FEATURES ................................................................ 7 Battery .............................................................................9 Replacing the 9-Volt Battery .....................................10 To remove the battery ..........................................13 To install the battery.............................................14 STORING YOUR ACTIVATOR IN ITS POUCH .......15 ACTIVATION BUTTON..................................................18 POSITIONING AND USING YOUR SYNCHROMED ACTIVATOR..........................20 How to use the SynchroMed Activator with your pump ....................................................21 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 6 INITIALIZATION .............................................................23 UNDERSTANDING THE SYNCHROMED ACTIVATOR LIGHTS AND SOUNDS........................25 TROUBLESHOOTING ....................................................29 WHEN TO CALL YOUR DOCTORS OFFICE .........................................................34 Call your doctors office if .........................................34 CLEANING AND CARE .................................................35 SPECIFICATIONS.............................................................37 Model 8831 SynchroMed Activator Specifications ...............................................................37 GLOSSARY.........................................................................38 LIMITED WARRANTY....................................................41 SERVICE..............................................................................45 WARRANTY REGISTRATION CARD.........................47 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 1 FCC INFORMATION The following is communications regulation information on the Model 8831 SynchroMed Activator. FCC ID: LF58831 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. 1 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 2 INTRODUCTION You have been supplied with a Model 8831 SynchroMed Activator that enables you to activate a programmed dose of medication prescribed by your doctor from your SynchroMed or SynchroMed EL Implantable Drug Pump. The SynchroMed Activator is one part of the system that was prescribed for you and should be used only according to the instructions given in this manual and those provided by your doctor. 2 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 3 This manual will describe how to:

activate a dose of medication from your pump;

determine if an activation was successful;

determine if enough time has elapsed since your previous dose to allow you to activate another; and understand the meaning of the lights on the back of your SynchroMed Activator and of the audio signals from the device. If you have questions unanswered by this manual, or if any unusual situations or problems arise, consult your doctor. He or she knows your personal medical history and can give you the detailed information you may need. In particular, you should ask about the potential complications, risks, and benefits of this therapy. Important terms appear in bold text and are listed in the glossary at the end of this manual. 3 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4 SYNCHROMED ACTIVATOR DESCRIPTION The SynchroMed Activator can talk and listen to your SynchroMed pump. When you activate your device, it sends a command to the pump to deliver a physician-programmed dose of medication. The SynchroMed Activator can also determine the timing of your most recent dose. Additionally, the SynchroMed Activator talks to you. Through a series of lights and beeps, the SynchroMed Activator tells you if you are successful in your attempt to activate the dose, if you are trying to activate a dose too soon since your last activation, and if the battery that powers your SynchroMed Activator is good. Your doctor will program your pump to accept commands from your SynchroMed Activator. Your doctor will program the number of doses per 24 hours you may receive and the interval before you may give yourself another dose, also known as the Interval Lockout. 4 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 5 Be sure to talk with your doctor about the number of doses prescribed for you and the interval lockout period between doses so you understand how the SynchroMed Activator is intended to work. Your doctor may have to adjust your dose periodically until a dose schedule is found that is best for your needs. Use with Other Implanted DevicesThe SynchroMed Activator can be used only with the SynchroMed family of pumps. The SynchroMed Activator is not compatible with other program-

mable pumps. The SynchroMed Activator may interfere with the operation of other implantable devices. Tell your doctor if you have another implanted device. 7 Warning Radio signals (telemetry) from the SynchroMed Activator may interfere with the performance of other implantable devices. Do not try to use the SynchroMed Activator to program another implantable device. 5 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 6 Additionally, the SynchroMed Activator operates best in an environment free from strong electromagnetic interference (EMI). Examples of sources of EMI include, but are not limited to: strong computer monitors, television sets, and other electronic equipment. 7 Caution The magnet in your SynchroMed Activator may interact with other implanted devices, impacting their operation or resetting their programs. If you have other implanted devices, talk with your doctor about the magnet in your SynchroMed Activator. Remember to keep your SynchroMed Activator away from cards with magnetic strips (credit/bank cards) and from computer monitors and TVs. Refer to the SynchroMed pump patient manual for information about equipment and conditions that may affect the operation of your pump. If the SynchroMed Activator quits working, your symptoms may recur. 6 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 7 SYNCHROMED ACTIVATOR COMPONENTS AND FEATURES This section describes the components and features of your SynchroMed Activator. The Activation Button is located on the top of the SynchroMed Activator (Figure 1), as is the battery cover. Finger Grips Activation Button Battery Cover Release Tab Battery Cover Figure 1. SynchroMed Activator top view. 7 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 8 On the bottom of the SynchroMed Activator (Figure 2), you will see four indicator lights and a target represented by a drawing of a hand holding a SynchroMed Activator. Target Symbol Successful Dose Activation Interval Lockout Incomplete Communication SynchroMed Activator Battery Status Medtronic Model 8831 SynchroMed Activator 9V 8 Figure 2. SynchroMed Activator bottom view. 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 9 When you use your SynchroMed Activator, the four indicator lights will help you understand how well the SynchroMed Activator is communicating with your pump. Each of the lights represents a different message:

Successful dose activation Interval lockout Incomplete communication SynchroMed Activator Battery status Refer to page 25 for a detailed explanation of each message. Battery Your SynchroMed Activator runs on one 9-volt battery. You should replace the battery in your SynchroMed Activator after every 12 weeks of typical use or when the battery light on the back of the SynchroMed Activator begins to blink or does not turn on. 9 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 10 If the battery in your SynchroMed Activator is good, the green battery light on the back of the device will remain lit. If the battery in your SynchroMed Activator begins to run low, the battery indicator light on the back panel will begin to blink. The SynchroMed Activator performs a self test each time a battery is installed. You will see all of the lights on the back of the SynchroMed Activator turn on and you will hear a beep when you replace the batteries in your SynchroMed Activator. Replacing the 9-Volt Battery Replace the battery in your SynchroMed Activator at least once every 12 weeks, or when the battery light on the back of the SynchroMed Activator begins to blink. 7 Warning Do not use a mercury or zinc-air battery. Do not use rechargeable batteries. 10 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 11 Dispose of depleted batteries according to local regulations. To remove the battery compartment cover (Figure 3):

1. Hold the SynchroMed Activator with one hand. 2. Press in the release button on the end of the SynchroMed Activator. 3. Lift off the cover. Figure 3. Battery compartment cover removal. 11 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 12 To replace the battery compartment cover:

1. Place the center hook on the edge of the cover into the center slot on the SynchroMed Activator (Figure 4). 2. Lower the battery compartment cover. 3. Press down the end of the cover to lock it in place. Figure 4. Battery compartment cover replacement. 12 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 13 To remove the battery:

1. Remove the battery cover. 2. Place one finger on the edge of the battery near the center bottom. 3. Lift the battery out of the compartment. To avoid damage to the SynchroMed Activator, do not use excessive force.

S N Figure 5. Battery removal. Note: When not using the SynchroMed Activator for more than 4 weeks, remove the battery to prevent corrosive damage to the device. 13 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 14 To install the battery:

1. Check the battery well for positive [+] and negative [-]

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. 1.

S N 2. Figure 6. Battery installation. 3. Replace cover. 14 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 15 7 Caution Do not press the Activation Button during battery installation, because the SynchroMed Activator may lock-up and become non-functional. If you think your SynchroMed Activator has locked up, remove the battery and insert a fresh battery. STORING YOUR ACTIVATOR IN ITS POUCH When you are not using your Activator, store it in its pouch. Items such as bank or credit cards (with magnetic strips) and floppy disks may be damaged by the magnet in your Activator. The pouch contains a hard metal shield that protects these types of items from the magnet (Figure 7). 15 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 16 Shield Under Mesh Figure 7. Pouch with magnetic shield. 16 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 17 Place the Activator in the pouch so that the back of the Activator

(the side with the lights) is against the side of the pouch that contains the shield (Figure 8). Figure 8. Storing your Activator in its pouch. 17 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 18 ACTIVATION BUTTON When you place the SynchroMed Activator over the pump and depress the Activation Button on your SynchroMed Activator, the SynchroMed Activator and the pump talk to each other. A clock in the SynchroMed Activator keeps track of your interval lockout periods. You cannot activate more doses than your doctor prescribes in one 24-hour period. 18 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 19 Activation Button Figure 11. Activation button. When you depress the activation button on the SynchroMed Activator, you will receive one of several messages in the form of lights and audible signals (refer to page 25, Understanding the SynchroMed Activator Lights and Sounds). 19 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 20 POSITIONING AND USING YOUR SYNCHROMED ACTIVATOR When you are ready to activate a dose, hold the SynchroMed Activator steadily over your drug pump for at least three seconds after you have pressed the activation button. You must hold the SynchroMed Activator steadily to ensure that the SynchroMed Activator and the pump communicate. Note: If the SynchroMed Activator is not properly centered over the pump after the activation button is pressed, successful communication between the SynchroMed Activator and the pump may not take place. 20 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 21 How to use the SynchroMed Activator with your pump:

Hold the SynchroMed Activator by the finger grips (Figure 1) on the sides of the device. Use the target symbol on the back of the SynchroMed Activator to help you align the SynchroMed Activator over the center of your pump (Figure 9). Press the Activation Button and hold. While the SynchroMed Activator is looking for the pump, you will hear continuous beeping. After you find the pump and the SynchroMed Activator communicates with it, the beeping will stop. You may need to move the SynchroMed Activator in a circular motion near your implanted pump in order for your SynchroMed Activator to find your pump. Note: If you move the SynchroMed Activator away from the pump too soon, the beeping will start again. If this happens, realign the SynchroMed Activator and try again. When your SynchroMed Activator has successfully communicated with your pump, you will hear a sequence of beeps (refer to page 25, Activator Lights and Sounds). 21 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 22 Figure 9. Correct placement of the SynchroMed Activator over a pump. 22 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 23 INITIALIZATION After you receive your SynchroMed Activator and each time your pump is reprogrammed or refilled, you must press the activation button to begin the interval lockout. (Refer to page 18, Positioning and Using Your SynchroMed Activator, and follow activation instructions). When the interval lockout period is over, you will be able to activate a dose. Remember your SynchroMed Activator cannot activate a dose the first time you use it. Instead, the device sets an interval lockout period the first time you activate after:

you first receive your SynchroMed Activator, your pump is refilled, or your doctor reprograms your pump. Activate your pump using your SynchroMed Activator as soon as possible after refill or programming to start the interval 23 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 24 lockout period the doctor has set. Ask your doctor how long this period lasts for you. You can activate a dose as soon as the interval lockout time ends, if needed. Figure 10 shows one example of a series of events from pump refill to interval lockout end. Note that activation is permitted outside the interval lockout period only. Initialize Activator Lockout Interval Lockout Period Interval Lockout Period Expires Patient Activation Interval Lockout Period Refill or Reprogram Pump 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Time (hours) Figure 10. Graphic representation of activation and interval lockout period. 24 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 25 UNDERSTANDING THE SYNCHROMED ACTIVATOR LIGHTS AND SOUNDS This section explains the light and sound messages your SynchroMed Activator sends you. Refer to Figure 2 as you read the text below. On the row of lights on the back of your SynchroMed Activator, the top light (SUCCESS) turns green immediately after you successfully activate a dose. If you try to activate a dose too soon after your last activation, a yellow light (second from the top) will turn on (INTERVAL LOCKOUT). If you try to activate a dose, and communication is not established with your pump, the third light in the row will turn on yellow (INCOMPLETE COMMUNICATION). 25 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 26 The green light at the bottom of the row (BATTERY STATUS) will remain green during activation as long as the 9-volt battery in your SynchroMed Activator is good. When the battery is low, the light will begin to blink green. (The light will not turn on at all if the battery is too low to operate the SynchroMed Activator.) All lights remain on for 8 seconds. Your SynchroMed Activator produces different series of beeps for various messages:

Three beeps (ascending tones) in rapid succession mean a dose activation was successful. Two beeps (ascending tones) in rapid succession mean your SynchroMed Activator was initialized following a programming session with your doctor. Two beeps (descending tones) in rapid succession mean one of the following:

You tried to activate a dose too soon following your most recent activation. 26 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 27 You tried to activate too many doses within a 24-hour period (more than prescribed by your doctor). Your SynchroMed Activator did not communicate completely with your pump within 10 seconds. Your pump has not been programmed for SynchroMed Activator use The beeper cannot be turned off, and the volume is not adjustable. Note: If you hear two beeps (descending tones), but you believe that your interval lockout period is over, try once more to activate a dose. If you are still unsuccessful, check your records to determine the number of doses activated in the past 24 hours (refer to pages 39-40). 27 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 28 Table 1. SynchroMed Activator Lights and Sounds SynchroMed Activator Sounds 3 beeps (ascending tones) 2 beeps (descending tones) 2 beeps (descending tones) None 2 beeps (ascending tones) SynchroMed Activator SynchroMed Activator Light Color Indicator Light Green light Successful dose activation Interval lockout Yellow light Incomplete communication Yellow light SynchroMed Activator battery status Green light=good Green light blinking=

replace battery Yellow light Initialization 28 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 29 TROUBLESHOOTING The following table presents potential difficulties that might occur when you are trying to use your SynchroMed Activator, and possible solutions for those difficulties. Table 2. Troubleshooting If this happens This might be why Try these steps No lights appear to be functioning Sunlight may be obscuring Shade the lights or the view move into a darker area The beeper does not sound, but the battery light is on No battery Very low battery Battery placement incorrect You may not be able to hear Move to a quieter area Replace the battery Check to see that the battery is inserted correctly the beeper because of noise around you The beeper may be broken Call your doctor 29 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 30 If this happens This might be why Try these steps The SynchroMed Activator does not respond to button presses Button may be broken No battery Very low battery Check to see that the battery is inserted correctly Replace the battery Call your physician if you you have checked and replaced the battery, but your Activator is still not responding 30 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 31 This might be why SynchroMed Activator If this happens SynchroMed Activator indicates that communi-

cation with pump was incomplete;

(incomplete light is yellow is not aligned properly and two descending tones sound) is not close enough

(within 5 cm) to the pump Try these steps Realign the SynchroMed Activator using the target on the device The SynchroMed Activator Ensure that the Synchro-

with the pump The SynchroMed Activator Med Activator is in contact with the skin or clothing directly over the pump; if necessary, ask someone to help you Excessive EMI (proximity to Position the SynchroMed strong computer monitors or Activator over the pump other electronic equipment) was moved too quickly away from the pump at least 3 seconds after you push the activation button. Do not move the SynchroMed Activator quickly away from the pump location Move away from possible EMI sources such as TVs or large computer monitors 31 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 32 If this happens This might be why Try these steps After communication with the pump, the SynchroMed Activator continually beeps and all lights flash All lights are on, but the device is non-functional The pump has a memory error Call your doctor immediately Self-test has failed Remove battery and insert new battery Contact your physician 32 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 33 Following are some guidelines for using your SynchroMed Activator. Do:

Use your SynchroMed Activator only as your doctor has explained to you. Handle your SynchroMed Activator with care. Do not drop, throw, or toss your SynchroMed Activator, or immerse it in water or any other liquid. Keep a fresh 9-volt battery on hand so that you can replace the SynchroMed Activator battery when needed. 33 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 34 WHEN TO CALL YOUR DOCTORS OFFICE Call your doctors office if:

you experience anything unusual, such as new or unexplained symptoms;

you notice that you begin to feel differently or worse;

your symptoms do not decrease with activation of a dose;

you are not getting adequate relief from your symptoms;

your symptoms have dramatically changed; or your SynchroMed Activator beeps continually following communication with the pump, and all lights flash. 34 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 35 CLEANING AND CARE The SynchroMed Activator is a precision instrument and should be handled with care. Disassembling or tampering with the internal components of the SynchroMed Activator could damage it and make it inoperable. Although the SynchroMed Activator construction is rugged, it should be protected against sharp blows or physical shocks. Do not drop or toss your SynchroMed Activator. Clean the outside of the SynchroMed Activator with a slightly damp cloth. Mild household cleaners will not damage the case or labels. Your SynchroMed Activator is water resistant, not waterproof. Do not immerse the SynchroMed Activator in water or any other liquid. Be careful to prevent moisture from entering the SynchroMed Activator. 35 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 36 7 Caution Do not immerse the SynchroMed Activator in liquid, or clean it with aromatic or chlorinated hydrocarbons, or acetone (for example, bleach or nail polish remover). If the battery contacts require cleaning, clean them with a cotton swab dampened with rubbing alcohol. Do not use a pencil eraser or sandpaper. Replace a depleted battery to ensure proper operation and to prevent corrosion. 36 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 37 SPECIFICATIONS Model 8831 SynchroMed Activator Specifications Power Source: 9-volt alkaline (type 6LR61 or 6F22E) battery Operating Temperature: 49F110F (9 C43C) Storage Temperature: -40F150F (-40C65C ) Relative Humidity: 1095%

SynchroMed Activator Size: Approximately 5.3x2.4x1.2 inches

(13.5x6.1x3.0 cm) SynchroMed Activator Weight: Approximately 7 oz (198g)

(including battery) Battery Life: 12 weeks (average) 37 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 38 GLOSSARY Dose ActivationThe initiation of a command from your SynchroMed Activator to your SynchroMed pump that tells the pump to activate a prescribed dose of medication. Incomplete CommunicationThe failure of your SynchroMed Activator to complete delivery of a message to your pump. InterferenceAnything that reduces the effectiveness or interferes with the communication between your SynchroMed Activator and pump. Interval LockoutA period of time during which you cannot activate a dose using your SynchroMed Activator. This time period is determined by your physician. 38 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 39 Retain the following information for your records and for your doctor. Date of Activation Time of Activations ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ 39 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 40 Date of Activation Time of Activations ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ ____________ 40 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 41 MEDTRONIC NEUROLOGICAL EQUIPMENT LIMITED WARRANTY

(U.S. Customers Only) A. This Limited Warranty provides the following assurance to the purchaser of the Medtronic Model 8831 SynchroMed Activator hereafter referred to as Equipment:

(1) Should the Equipment fail to function within normal tolerances due to a defect in materials or workmanship within a period of one (1) year, commencing with the delivery of the Equipment to the purchaser, Medtronic will at its option: (a) repair or replace any part or parts of the Equipment; (b) issue a credit to the purchaser equal to the Purchase Price, as defined in Subsection A(2), against the purchase of the replacement Equipment or (c) provide a functionally comparable replacement Equipment at no charge. 41 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 42

(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 Medtronic within thirty (30) days after discovery of the defect (Medtronic may, at its option, repair the Equipment on site).

(2) The Equipment must not have been repaired or altered outside of Medtronic's factory in any way which, in the judgment of Medtronic, affects its stability and reliability. The Equipment must not have been subjected to misuse, abuse, or accident. 42 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 43 C. This Limited Warranty is limited to its express terms. In particular:

(1) Except as expressly provided by this Limited Warranty, MEDTRONIC IS NOT RESPONSIBLE FOR ANY DIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES BASED ON ANY DEFECT, FAILURE, OR MALFUNCTION OF THE EQUIPMENT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE.

(2) This Limited Warranty is made only to the purchaser of the Equipment. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM, OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON. 43 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 44

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. If any part or term of this Limited Warranty is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the Limited Warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the particular part or term held to be invalid. This Limited Warranty gives the purchaser specific legal rights. The purchaser may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this Limited Warranty.

* This Limited Warranty is provided by Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the Limited Warranty. 44 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 45 SERVICE The SynchroMed Activator has been carefully engineered and tested to provide long, trouble-free service. If repair or service is necessary, call Medtronic at 1-800-328-0810. To register the activator for service covered by the limited warranty, complete and mail the warranty registration card inserted in this manual. A serial number, located within the battery compartment identifies each activator. If you write or call Medtronic about your activator, refer to the serial number. 45 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 46 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 47 NO POSTAGE NECESSARY IF MAILED IN THE UNITED STATES BUSINESS REPLY MAIL FIRST-CLASS MAIL PERMIT NO. 7611 MINNEAPOLIS, MN POSTAGE WILL BE PAID BY ADDRESSEE MEDTRONIC NEUROLOGICAL DEVICE REGISTRATION MS LN385 PO BOX 59262 MINNEAPOLIS MN 55459-9895 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 48 IMPORTANT: Please detach, fill out, and mail this card to register your activator.

(The serial number is located under the 9-volt battery.) SynchroMed Activator Model 8831 Warranty Registration Card Serial Number: N G M Purchase Date:

(Mo)

(Day)

(Yr) Name:

Name:

Address:

(Last) City:

Zip Code:

Implant Physician Name:

Phone:

) Hospital Name:

Address:

City:

Zip Code:

(Last)

(First) State:

Phone:

State:

(Area Code)

(First) 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 49 200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 50 Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 763-505-5000 Toll-free 1-800-328-0810 Fax 763-505-1000 UC200102537 EN PN198565-001 Medtronic, Inc. 2001 All Rights Reserved