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.
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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.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 4 Explanation of Symbols Status Light Symbols Successful Dose Activation Interval Lockout Incomplete Communication 9V Activator Battery Status Miscellaneous Symbols y IEC 60601-1, Type BF Equipment w 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.
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 ......................
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 DOCTOR’S OFFICE .........................................................34 Call your doctor’s office if .........................................34 CLEANING AND CARE .......................................
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.
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.
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.
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.
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 Devices—The SynchroMed Activator can be used only with the SynchroMed family of pumps.
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.
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.
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 Medtronic® Model 8831 SynchroMed® Activator Interval Lockout Incomplete Communication 9V SynchroMed Activator Battery Status 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.
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.
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.
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.
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. + SN 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.
0102537EN/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. + 2. SN Figure 6. Battery installation. 3. Replace cover.
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.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 16 Shield Under Mesh Figure 7. Pouch with magnetic shield.
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.
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.
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”).
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.
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.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 22 Figure 9. Correct placement of the SynchroMed Activator over a pump.
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.
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.
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.
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.
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.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 28 Table 1.
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.
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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.
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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.
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.
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: 49˚F—110˚F (9˚ C—43˚C) Storage Temperature: -40˚F—150˚F (-40˚C—65˚C ) Relative Humidity: 10—95% SynchroMed Activator Size: Approximately 5.3x2.4x1.2 inches (13.5x6.1x3.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 38 GLOSSARY Dose Activation—The initiation of a command from your SynchroMed Activator to your SynchroMed pump that tells the pump to activate a prescribed dose of medication. Incomplete Communication—The failure of your SynchroMed Activator to complete delivery of a message to your pump. Interference—Anything that reduces the effectiveness or interferes with the communication between your SynchroMed Activator and pump.
200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 39 Retain the following information for your records and for your doctor.
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200102537EN/198565_001.qxd 4/26/01 11:51 AM Page 41 MEDTRONIC® NEUROLOGICAL EQUIPMENT LIMITED WARRANTY (U.S. Customers Only) A.
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).
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.
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.
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.
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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.
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.
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200102537EN/198565_001.qxd 4/26/01 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 11:51 AM Page 50 UC200102537 EN PN198565-001 © Medtronic, Inc.
