220875_fcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 MODEL 2696 INCHECKTM Patient Assistant Physicians manual
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Caution: Investigational device. Limited by federal law (USA) to investigational use. 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_fcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Explanation of symbols on the packaging and literature w y Attention: See accompanying documentation Type BF equipment Battery polarity as shown Serial number n i Storage temperature c For United States audiences only only Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician Medical device Telemetry (communication signal) status light lit 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_fcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Explanation of symbols on the device AF?
Query button (Press to request implanted device to check for AF) OK symbol (AF is not present) AF symbol (AF is present) Therapy button (Press to instruct implanted device to deliver atrial cardioversion therapy) Record Symptoms button (Press to instruct the implanted device to record cardiac activity) Record symbol (recorded cardiac activity) y Type BF equipment Low Batteries symbol Battery polarity as shown Attention: See accompanying documents w c For United States audiences only only Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_fcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875TOC.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Table of contents 1 Description and intended use 7 2 Contents of the Patient Assistant box 8 2.1 Inspection 2.2 Installation and setup 9 9 3 Checking the patients heart rhythm 3.1 How to check the patients heart rhythm 3.2 Response when a query is requested 9 9 12 4 Requesting atrial cardioversion therapy 13 4.1 How to request cardioversion therapy 4.2 Response when therapy is requested 4.3 When the Therapy button will appear 4.4 If therapy is not delivered 16 13 15 16 5 Recording cardiac information 17 5.1 How to record cardiac information 5.2 Response when record symptoms is requested 17 18 6 Battery information 19 6.1 Replacement batteries 6.2 When to install batteries 6.3 How to install new batteries 19 19 20 7 Maintenance 21 7.1 Care and handling 7.2 Cleaning 7.3 Service 22 22 21 5 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875TOC.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 7.4 Disposal 22 8 Troubleshooting 23 9 Specifications 25 9.1 Device specifications 9.2 Safety and compatibility standards 25 26 6 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 1 Description and intended use The Model 2696 InCheckTM Patient Assistant shown on Figure 1 is a hand-held, battery powered, radio frequency communication device. The Patient Assistant communicates with certain implantable Medtronic cardiac devices that provide patient-
activated features. See the manual for the implanted device for compatibility information. The Patient Assistant can send simple programming commands to the implanted device, and receive and display information about the patients cardiac rhythm. Telemetry status light Query button, press to check for AT/AF episode detection AF?
Symbol and button display area Record Symptoms button, press to record cardiac event data Wrist strap connector Figure 1. Patient Assistant (Not actual size) Intended use The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the patient management features in the implanted device, depending on the implanted device model and the programmed features:
To verify whether the implanted device has detected a suspected atrial arrhythmia. 7 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 To initiate recording of cardiac event data in the implanted device memory. To request atrial cardioversion therapy, if supported by the implanted device and patient activated therapy has been previously programmed by the physician. Therapy is allowed when the implanted device is currently detecting an atrial arrhythmia episode and all conditions for delivering therapy have been met. Note:
Ventricular arrhythmia therapy cannot be patient activated using the Patient Assistant. 2 Contents of the Patient Assistant box The following should be found in the Patient Assistant box:
One Patient Assistant Two N-size 1.5 V batteries One carrying case One wrist strap One physicians manual One quick reference guide/patient ID card Two warranty cards (USA and outside USA) One patient manual The Patient manual includes blank lines in sections 3 and 7 for the patients prescription information. This information includes when to use the Patient Assistant, which button to press and what actions to take for each reply. 8 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 The Quick Reference Guide/Patient ID Card provides a more portable version of the basic instructions for using the Patient Assistant. Blank lines are provided for name and telephone number information. 2.1 Inspection Inspect the Patient Assistant for damage or defects. If the case is cracked or other defects are discovered, return the Patient Assistant to Medtronic. 2.2 Installation and setup Place new batteries in the Patient Assistant (see page 20). Press either front panel button to test the Patient Assistant. The telemetry status light flashes green for about 15 seconds, and the Patient Assistant gives a short beep. This confirms that the batteries can operate correctly. Provide the necessary information in the Patient manual and Quick Reference Guide/Patient ID Card. Refer to the implantable device reference manual for information about its features that apply to the Patient Assistant. 3 Checking the patients heart rhythm 3.1 How to check the patients heart rhythm Note: The Patient Assistant may not communicate at full strength outside the range of 8 C (16 F) to 43 C (110 F). 1. Press the Query button. Verify that the telemetry status light flashes green, and the Patient Assistant gives a short beep. If these responses do not occur, see page 23. 9 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 2. Place the Patient Assistant against the implanted device. See Figure 2. AF?
Figure 2. Positioning the Patient Assistant 3. Listen for a long beep or look to see if the telemetry status light is solid green. Lift the Patient Assistant to see what appears on the display area (Figure 3). Note: If the Patient Assistant does not respond in about 15 seconds, it did not communicate successfully with the implanted device. Repeat steps 1 through 3. Note: Pressing the Therapy button will cause the implanted device to deliver atrial cardioversion therapy. See page 16 for information about when the Therapy button will appear. 10 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 AF?
Figure 3. Patient Assistant with all symbols displayed for reference 11 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 3.2 Response when a query is requested The Patient Assistant displays the appropriate symbols for about 10 seconds after receiving a response from the implanted device. Display Definition OK symbol: The implanted device is not detecting an atrial tachyarrhythmia episode. AF symbol: The implanted device is detecting an atrial tachyarrhythmia episode. Therapy button: Atrial cardioversion therapy is allowed. See Requesting atrial cardioversion therapy on page 13 for more information. Telemetry status light flashes for about 15 seconds and goes out. The Patient Assistant did not communicate with the implanted device. Low Batteries symbol: The Patient Assistant batteries are low and should be replaced soon. 12 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 4 Requesting atrial cardioversion therapy 4.1 How to request cardioversion therapy Note: The Patient Assistant may not communicate at full strength outside the range of 8 C (16 F) to 43 C (110 F). Note: Pressing the Therapy button will cause the implanted device to deliver atrial cardioversion therapy. See page 16 for information about when the Therapy button will appear. Instruct the patient to sit down or lie down in a comfortable position. Use the wrist strap if desired. 1. 2. Press the Query button. Verify that the telemetry status light flashes green, and the Patient Assistant gives a short beep. If these responses do not occur, see page 23. 3. Place the Patient Assistant against the implanted device (see Figure 4). AF?
Figure 4. Positioning the Patient Assistant 13 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 4. Listen for a long beep or look to see if the telemetry status light is solid green. Lift the Patient Assistant to see what appears on the display area (Figure 5). Note: If the Patient Assistant does not respond in about 15 seconds, it did not communicate successfully with the implanted device. Repeat steps 1 through 4. 5. Press the Therapy button (if lit after pressing the Query button). The telemetry status light will flash red. Note: The Therapy button will stay lit for about 10 seconds after the query. If the Therapy button goes out before it can be pressed, repeat steps 1 through 4. 6. Place the Patient Assistant against the implanted device. 7. Listen for a long beep and look to see if the telemetry status light is solid red. Lift the Patient Assistant to see what appears on the display area (Figure 5). Note: If the Patient Assistant does not respond in about 15 seconds, it did not communicate successfully with the implanted device. Repeat steps 1 through 7. 14 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 AF?
Figure 5. Patient Assistant with all symbols displayed for reference 4.2 Response when therapy is requested The Patient Assistant displays the appropriate symbols for about 10 seconds after receiving a response from the implanted device. Display
(flashing) Definition OK symbol: The implanted device is not detecting an atrial tachyarrhythmia episode. Appears if the AF has stopped since pressing the Query button. AF symbol: The implanted device is detecting an atrial tachyarrhythmia episode. Flashing Therapy button: Therapy will be delivered soon. In most cases, therapy will be delivered in about 10 seconds. The maximum time it takes the implanted device to prepare to deliver therapy is about 1 minute. 15 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Display No Therapy button. Telemetry status light flashes for about 15 seconds and goes out. Medtronic Confidential implant_R02 Definition Therapy will not be delivered. Telemetry status light is solid red with no flashing button. See section 4.4. The Patient Assistant did not communicate with the implanted device. Low Batteries symbol: The Patient Assistant batteries are low and should be replaced soon. 4.3 When the Therapy button will appear The Therapy button appears after pressing the Query button when the following conditions are met:
The implanted device supports patient activated therapy. Patient activated therapy is enabled in the implanted device. The patient is in AT/AF. All conditions to deliver atrial therapy are met. 4.4 If therapy is not delivered If the Patient Assistant gives a long beep and the Therapy button goes dark without flashing, the atrial cardioversion therapy was cancelled before delivery. The typical reasons are:
The atrial rate cannot be confirmed. The ventricular rate is too fast. Refer to the reference manual for the implanted device for more possible explanations and programming options. 16 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 5 Recording cardiac information 5.1 How to record cardiac information Note: The Patient Assistant may not communicate at full strength outside the range of 8 C (16 F) to 43 C (110 F). 1. Press the Record Symptoms button. Verify that the telemetry status light flashes green, and the Patient Assistant gives a short beep. If these responses do not occur, see Troubleshooting on page 23. 2. Place the Patient Assistant against the implanted device. See Figure 6. AF?
Figure 6. Positioning the Patient Assistant 3. Listen for a long beep or look to see if the telemetry status light is solid green. Lift the Patient Assistant to see what appears on the display area (Figure 7). Note: If the Patient Assistant does not respond in about 15 seconds, it did not communicate successfully with the implanted device. Repeat steps 1 through 3. 17 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 AF?
Figure 7. Patient Assistant with all symbols displayed for reference 5.2 Response when record symptoms is requested The Patient Assistant displays the appropriate symbols for about 10 seconds after receiving a response from the implanted device. Display Definition Record symbol: The implanted device successfully recorded heart rhythm information. Telemetry status light flashes for about 15 seconds and goes out. The Patient Assistant did not communicate with the implanted device. Low Batteries symbol: The Patient Assistant batteries are low and should be replaced soon. 18 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 6 Battery information 6.1 Replacement batteries The Patient Assistant operates with two N-size 1.5 volt batteries. The recommended battery type is alkaline manganese dioxide, type ANSI/NEDA 910A and IEC LR1. This battery is available from the following manufacturers:
Duracell Model MN9100 Kodak Model KN Rayovac Model RN-2 Panasonic Model AM5 Varta Model 4001 Energizer Model E90 These batteries can be purchased at a retail store, camera store, battery speciality store, electronics store, or from an Internet retailer. 6.2 When to install batteries Install new batteries before giving the Patient Assistant to a patient. If the Low Batteries symbol appears, replace both batteries soon. The Patient Assistant will operate for several more uses after the initial appearance of the Low Batteries symbol. Note: Follow local regulations for proper disposal of used batteries. 19 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 6.3 How to install new batteries 1. Slide the battery cover tab toward the center of the Patient Assistant and push upward to open the battery compartment. Figure 8. Replacing the batteries. 2. Remove the old batteries. 3. Insert the new batteries according to the polarity shown on the battery compartment. 4. Snap the battery cover closed. 5. Verify that the Patient Assistant beeps and that the telemetry status light flashes when the Query button or the Record Symptoms button is pressed. This confirms that the new batteries have sufficient charge to operate the Patient Assistant. 20 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 7 Maintenance 7.1 Care and handling The Patient Assistant is designed for robust use, to be carried and handled on a daily basis. However, it is a precision electronic instrument and precautions should be taken to avoid damage. To preserve battery life, remove the batteries when the Patient Assistant is not used for long periods of time or exposed to temperatures below 15 C (60 F). Electronic devices are susceptible to many environmental stresses. Precautions should be taken to avoid damage to the unit, including (but not limited to) those listed here. Precautions:
To prevent unintentional delivery of patient-activated therapy, instruct your patient not to carry the Patient Assistant in a pocket directly over the implanted device. Do not immerse the Patient Assistant in liquid. Do not clean the Patient Assistant with solvents or chlorine based cleansers (for example, nail polish remover or bleach). Do not drop the Patient Assistant or mishandle it in a way that might physically damage the Patient Assistant. Avoid spilling fluid on the Patient Assistant. Do not immerse in liquid. Do not open the Patient Assistant, except to install batteries. Do not sterilize the device by gamma irradiation and do not steam sterilize (autoclave) the Patient Assistant. 21 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Electromagnetic interference (EMI) can impair the proper performance of the Patient Assistant. Normal operation can be restored by moving away from the source of the interference. Other environmental factors may impact proper performance of the Patient Assistant. Use of good electronic device practices will help to prevent environmental damage to the unit. 7.2 Cleaning Be careful to prevent moisture from entering the Patient Assistant. The Patient Assistant is moisture resistant, but not waterproof. Clean the outside of the Patient Assistant with a slightly damp cloth. Mild household cleaners will not damage the case or labels. 7.3 Service The Medtronic Model 2696 InCheckTM Patient Assistant has been carefully engineered, manufactured and quality tested to provide long, trouble-free service. Should service or repair be necessary, contact your local Medtronic representative at the appropriate address or telephone number on the back cover of this document. Please refer to the model number (Model 2696) and serial number
(located on the rear panel) when calling Medtronic. 7.4 Disposal Follow local regulations for proper disposal of the Patient Assistant at the end of its useful service life. 22 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 8 Troubleshooting The following list can be used to help solve possible problems with the Model 2696 Patient Assistant. Problem Telemetry status light does not flash, no beep. Possible causes The batteries are inserted backwards. The batteries are depleted. Possible solutions Re-install the batteries. Replace the batteries. Wrong type batteries. Verify that batteries are N-size, 1.5 V. A button is broken. Replace the Patient Assistant. Component failure. Telemetry status light flashes, no beep. The speaker has failed. Replace the Patient Assistant.
Use response on the display area.
Replace Patient Assistant. 23 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Problem Telemetry status light stops flashing without a response after the button press. Possible causes Insufficient telemetry. Patient Assistant did not communicate with the implanted device. Repeated failures Electromagnetic interference. Patient Assistant is outside its temperature range:
8 C (16 F) to 43 C
(110 F). Possible solutions Reposition Patient Assistant.
Improve Patient Assistant position over implanted device.
Circle the Patient Assistant slowly over the implanted device.
Move away from the source of interference. Move to warmer or cooler surroundings. Patient Assistant needs repair. Contact a Medtronic representative. 24 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 9 Specifications 9.1 Device specifications Dimensions: Approximately 96 mm x 56 mm x 22 mm
(3.77" x 2.20" x 0.86") Power source: 2 N-size 1.5 volt batteries, alkaline (manganese dioxide) Battery dimensions: 10 mm diameter x 30 mm (0.39 x 1.18) Battery longevity: 180 uses minimum, when used once a day at room temperature.1 Operating temperature: 8 C (16 F) to 43 C
(110 F) Transport and storage (batteries not installed):
Ambient temperature: -40 C (-40 F) to 66 C (150 F) Relative humidity: up to 95%
Audible output level: 65 dBA minimum at 96 mm (6") Classification with respect to electric shock: Internally powered Protection from electric shock (IEC 60601-1): Type BF Protection against ingress of liquids: Ordinary equipment Mode of operation: Short term 1 Operating the Patient Assistant below 15 C (60 F) for extended periods of time will shorten battery longevity 25 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_CH.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 9.2 Safety and compatibility standards The Model 2696 Patient Assistant complies with the following standards:
IEC 60601-1, Medical electrical equipment safety IEC 60601-1-2, Electromagnetic compatibility EN45502-1, Safety, marking and information of medical devices 26 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_bcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Sales offices:
Asia: Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza, The Lee Gardens, 33 Hysan Avenue, Causeway Bay, Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313 Medtronic Asia Ltd. 3 Floor Peter Building, 570-6 Shinsa-Dong Kangnam-ku, Seoul 135-120, South Korea Tel. 82-2-548-1148 Fax 82-2-518-4786 Australia: Medtronic Australasia Pty. Ltd. Unit 4/446 Victoria Road, Gladesville NSW 2111 Tel. 02-9879-5999 Fax 02-9879-5100 Austria: Medtronic sterreich GmbH Millennium Tower, Handelskai 94-96, 1200 Vienna Tel. 01-24044 Fax 01-24044-100 Belgium: Medtronic Belgium S.A. Boechoutlaan 55, 1853 Strombeek-Bever Tel. 02-456-0900 Fax 02-460-2667 Canada: Medtronic of Canada Ltd. 6733 Kitimat Road, Mississauga, Ontario L5N 1W3 Tel. 905-826-6020 Fax 905-826-6620 Denmark: Medtronic-ViCare A/S Birkerd Kongevej 150B, DK-3460 Birkerd Tel. 45-823366 Fax 45-823365 Finland: Medtronic Finland OY/LTD Sahaajankatu 24, PO Box 230, FIN-00810 Helsinki Tel. 9-755-2500 Fax 9-755-25018 France: Medtronic France S.A.S. 122, avenue du Gnral Leclerc, 92514 Boulogne-Billancourt Cedex Tel. 01-5538-1700 Fax 01-5538-1800 Germany: Medtronic GmbH Emanuel-Leutze-Strae 20, 40547 Dsseldorf, PO Box 110738 Tel. 0211-52930 Fax 0211-5293100 Osterfeldstrae 86, 85737 Ismaning, Tel. 089-321-4000 Fax 089-321-40010 Willhoop 1, 22453 Hamburg Tel. 040-554-9480 Fax 040-554-94822 Leipziger Chaussee 191g, 06112 Halle/Saale Tel. 0345-58081-11 Fax 0345-58081-22 Greece: Medtronic Hellas S.A. Agias Varvaras 5, 15231 Halandri, Athens Tel. 30-2-10-677-9099 Fax 30-2-10-677-9399 Italy: Medtronic Italia SpA Viale Fulvio Testi, 280 - Scala A, 20126 Milano Tel. 02-661641 Fax 02-6427488 Via Lucrezio Caro, 63, 00193 Roma Tel. 06-328141 Fax 06-3215812 Japan: Medtronic Japan Solid Square West Tower 6F, 580 Horikawa-cho, Saiwai-ku, Kawasaki, Kanagawa 210-0913 Tel. 044-540-6112 Fax 044-540-6200 Latin America Headquarters: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel. 763-514-4000 Fax 763-514-4879 The Netherlands: Medtronic B.V. Earl Bakkenstraat 10, PO Box 2542, 6401 DA Heerlen Tel. 031-45-566-8000 Fax 031-45-566-8668 Norway: Medtronic Vingmed AS Fjordveien 1, Postboks 366, 1323 Hvik Tel. 67-580680 Fax 67-101212 Portugal: Medical Implant Portugal, Lda. Rua Toms da Fonseca, Torre E 8, andar A,B, 1600 - 209 Lisboa Tel. 21-724-5100 Fax 21-724-5199 Spain: Medtronic Ibrica, S.A. Centro Empresarial Miniparc III, Edificio K, Calle Calndula, 93, El Soto de la Moraleja, 28109 Alcobendas Madrid Tel. 91-625-0400 Fax 91-650-7410 Sweden: Medtronic AB Dackevgen 33, Box 265, S-177 25 Jrflla Tel. 08-5222-0000 Fax 08-5222-0050 Switzerland: Medtronic (Schweiz) AG Route du Molliau 31, Case Postale 84, CH-1131 Tolochenaz Tel. 41-21-803-8000 Fax 41-21-803-8099 U.K. and Ireland: Medtronic U.K. Ltd. Suite 1, Sherbourne House, Croxley Business Center, Watford, Herts WD1 8YE, United Kingdom Tel. 1923-212213 Fax 1923-241004 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table. 220875_bcv.fm 3/13/03 10:11 am UC200203829 EN 4.625 x 6 inches (117 mm x 152 mm) Medtronic Confidential implant_R02 Manufacturer Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.medtronic.com Tel. 1-763-514-4000 Fax 1-763-514-4879 Medtronic E.C. Authorized Representative/Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic Europe Srl Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Internet: www.medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900
*220875001*
Medtronic, Inc. 2003 All Rights Reserved 220875001 March 2003 220875001 Rev A Printing instructions: doc#163256;
refer to Implant man. row in the applicable table.