R9G0034-4458AbioCor RF Communication Module

AbioCor Handheld Monitor INSTRUCTIONS FOR USE ® ® CAUTION: IMPORTANT NOTICE: Read the entire Instructions for Use before using the Handheld Monitor. The Handheld Monitor is to be used only in accordance with the Instructions for Use. Manufactured by: ABIOMED, Inc. 22 Cherry Hill Drive Danvers, MA 01923 USA N. America: 800-422-8666 (24-Hour Emergency Hotline) or 978-777-5410 Document No. 0034-0980-00006 Rev. A DRAFT July 2004 © 2004 ABIOMED, Inc. All rights reserved. Information contained in this document is subject to change without notice. ABIOMED, AbioCor, and the ABIOMED logo are registered U.S. trademarks of ABIOMED, Inc. The AbioCor ® Implantable Replacement Heart System is covered by one or more United States Patents and patents pending. Contents Cautions..............................................................................................................1 Overview.............................................................................................................2 Components of the Handheld Monitor................................................................3 Controls and Features........................................................................................5 Resolving Alarms................................................................................................7 Checking AbioCor ® Status................................................................................13 Checking AbioCor ® Settings and Alarm History...............................................15 Charging the Battery.........................................................................................19 Troubleshooting................................................................................................21 Care and Cleaning............................................................................................23 Appendix: Federal Communications Commission (FCC) Notice...................A.1 About This Manual This manual provides the Instructions for Use for the Handheld Monitor used by patients who have received the AbioCor ® Implantable Replacement Heart System. These Instructions for Use are intended to be used by clinicians, caregivers, and AbioCor patients. For more information about the AbioCor System, refer to the AbioCor Implantable Replacement Heart System - Operator’s Manual; the AbioCor Console Alarms - User’s Guide; and the Patient- Carried Electronics [PCE] - Instructions for Use. 1 Cautions NOTE: A caution indicates a situation in which equipment may malfunction, be damaged, or cease to operate. • Do not use the Handheld Monitor close to an operating AbioCor ® Console. The RF signals from the AbioCor Console and the Handheld Monitor will interfere with each other and not allow adjustments to be made to the Implanted System. If RF interference occurs, turn off the Handheld Monitor. • The Handheld Monitor does not use an indicator to display the status of its battery. However, the alarm message “Handheld Battery” is displayed when the battery is low. You should charge the Handheld Monitor battery every night, whether it is used or not. Overview 2 Overview The Handheld Monitor is a Personal Digital Assistant (PDA) that communicates with the AbioCor ® Implanted Controller. This allows you to quickly access important information about the AbioCor without using the Console. You can use the Handheld Monitor to: • Respond to a Heart Alarm on the PCE Module. • Check AbioCor ® status. • Check AbioCor ® settings and alarm history. You cannot make changes to Beat Rate, Motor Speed, or Balance settings using the Handheld Monitor. These changes must be made using the Console. Before using the Handheld Monitor, you must be trained in the operation of the PCE and the Console. 3 Components of the Handheld Monitor • RF Expansion Module – allows the Handheld Monitor to communicate with the Implanted Controller; draws power from the Handheld Monitor’s battery (even when the unit is off). • Handspring ™ Personal Digital Assistant (PDA) – standard PDA used as the interface component of the Handheld Monitor. • Stylus – used to select items on the screen (fingers can also be used). • Charger – plugs into an AC outlet to charge the Handheld Monitor’s battery. Components of the Handheld Monitor 4 RF Expansion Module Charger Handspring ™ PDA Stylus 5 Controls and Features • Life-Threatening Alarm Light – flashes when a life-threatening alarm condition exists; it also flashes briefly when the RF Expansion Module is inserted. • Application Button – used to access the AbioCor ® Settings Screens and Alarm History Screen. • Power Button – turns the Handheld Monitor on and off; the screen automatically turns off (to save power) if the unit has not been used for 2 minutes. • Touch-Sensitive Screen – displays information; responds to the stylus. • Scroll Buttons, Up/Down Arrows, and Scroll Bar – used to move through information on the screen. Controls and Features 6 Life- Threatening Alarm Light Application Button Up/Down Arrows Scroll Buttons Scroll Bar Touch- Sensitive Screen (Not used) Power Button 7 Resolving Alarms 1 The Handheld Monitor’s AbioCor ® Alarms screen allows you to view two types of alarms: active and inactive. • Active alarm – an existing alarm that has not been acknowledged (“silenced”); indicated by a flashing alarm message. • Inactive alarm – an existing alarm that has been acknowledged; becomes active again if it is not resolved within 2 minutes; indicated by a solid (not flashing) alarm message. NOTE: Alarms that have been resolved without action or acknowledgement may be displayed as solid alarm messages. Resolving Alarms 8 2 Alarms are divided into three levels: Life Threatening, Serious, and Advisory. The following message display methods are used to distinguish each level: • Life Threatening – Active: flashes between black text on light background and light text on black background. Inactive: solid light text with black background. • Serious – Active: flashes …

Text truncated - open the document above for the full version.

ABIOMED  , Inc. CHERRY HILL DRIVETEL: 978-777-5410 DANVERS, MASSACHUSETTS 01923FAX: 978-777-5692 U.S.A. June 29, 2004 Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 RE:Request for Confidentiality under 47 CFR § 0.457(d) and/or § 0.459 in ABIOMED, Inc.’s Application for Equipment Certification FCC ID: R9G-0034-4458 Dear Sir or Madam: ABIOMED, Inc. hereby requests that the materials and information specified below in ABIOMED, Inc.’s Application of Equipment Certification for the AbioCor  RF Com (part number 0034-4590) be withheld from public inspection. This request for confidentiality is made pursuant to 47 CFR §§ 0.457(d) and 0.459. In compliance with the requirements of 47 CFR § 0.459, we provide the following specific information. • 47 CFR § 0.459(a). A copy of this request is attached to and covers all of the material and information to which it applies, which materials and information are physically separate from any materials and information in the application to which the request does not apply. The material and information to be kept confidential include, without limitation: • All Schematics • All Block Diagrams • All Operational and/or Functional Design Descriptions • 47 CFR § 0.459(b). ABIOMED, Inc. requests that the above material and information be withheld from public inspection for at lease the reasons set forth below. • 47 CFR § 0.459(b)(1). The specific materials and information for which confidential treatment is sought is set forth above. All such materials and information are physically separate from any materials and information in the application to which the request does not apply. A copy of this request is attached to the materials and information covered by this request. • 47 CFR § 0.459(b)(2). This request is made in connection with the above- referenced Application for Equipment Certification, FCC ID: R9G-0034-4458. • 47 CFR § 0.459(b)(3). The materials and information to which this request applies contain ABIOMED, Inc. proprietary and confidential information, which information constitutes substantial ABIOMED, Inc. trade secrets. ABIOMED  , Inc. • 47 CFR § 0.459(b)(4). The materials and information to which this request applies do not concern a service. • 47 CFR § 0.459(b)(5). ABIOMED, Inc. has invested extensive resources to produce the product described in the above-referenced application and to develop the trade secret information included in the materials and information covered by this request. Disclosure of those materials and information would reveal ABIOMED, Inc.’s trade secrets and give competitors unfair commercial advantage in developing similar products. • 47 CFR § 0.459(b)(6). ABIOMED, Inc. has maintained the confidentiality of the trade secret information contained in the materials covered by this request by taking the customary measures for protecting proprietary and confidential trade secret information. • 47 CFR § 0.459(b)(7). To the best of ABIOMED, Inc.’s knowledge, the information contained in the materials covered by this request have not been made publicly available and have been disclosed to third parties only subject to non-disclosure agreements. • 47 CFR § 0.458(b)(8). ABIOMED, Inc. requests that the information contained in the materials covered by this request should not be available for public disclosure indefinitely as long as such information remains ABIOMED, Inc. trade secrets or, in the alternative, as long as permitted under the relevant laws and regulations. If additional information or explanation is required to grant this request, please contact the undersigned at 978-646-1478 or [email protected] . Sincerely, Tracy Palmer Berns Regulatory Affairs Manager and Staff Attorney

ABIOMED  , Inc. 0034-4458 RF Com External Photos 0034-4458 RF Com - Front View ABIOMED  , Inc. 0034-4458 RF Com – Back View

ABIOMED The Netherlands 5692 DA Son en Breugel Ekkersrijt 4006 ABIOMED B. V. REPRESENTATIVE: EUROPEAN SERIAL NO. CATALOG NO. RF Communication Module 8. Attach overlay laminate to top section of label with peel off on bottom section. Overlay laminate boundary shall Storage: Dry, 50 - 85 °F. Equivalent, Date of Manufacturer, P. O. Number, and Certification to UL and CSA Standards: LI 1003E or Font: Arial, unless otherwise specified. Finished Size: 5.25" x 2.88" with 0.06" Radius Corners otherwise specified. Red: Pantone PMS 185M Ink Color(s): All content Black on White backround unless Laminate; 2 Mil Matte Clear Mylar Overlay Laminate. Material: MM-200 Mylar with OM-100 Compucal 3. 7. 6. 5. 4. Quantity. 2. 1. Notes Adhesive: L23 USA Danvers, MA 01923 22 Cherry Hill Drive ABIOMED, Inc. Bottom Section ----------------------------- Top Section SN R REF AbioCor ABIOMED, Inc. 0034-0966-00207-BX1.dwg 0034-0966-00207-BX1 RF COM. MODULE CAD FILE: 6/23/04 DO NOT SCALE DRAWING BS APPROVALS DRAWN CHECKED RESP ENG MFG ENG A SCALE NONE DATE SIZEDWG. NO. Certification Here Place UL/CSA 0034-0966-00207C OF REV. SHEET 1 LABEL 1 See Note 9 REVISIONS R DESCRIPTIONLTR APPROVEDDATE not interfere with any content. 0034-4458 RED EUROSTILE FONT This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept and interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Abiomed Inc. could void the user's authority to operate the device. FCC ID: R9G-0034-4458 A B I O M E D T h e N e t h e r l a n d s 5 6 9 2 D A S o n e n B r e u g e l E k k e r s r i j t 4 0 0 6 A B I O M E D B . V . R E P R E S E N T A T I V E : E U R O P E A N S E R I A L N O . C A T A L O G N O . R F C o m m u n i c a t i o n M o d u l e U S A D a n v e r s , M A 0 1 9 2 3 2 2 C h e r r y H i l l D r i v e A B I O M E D , I n c . S N R R E F A b i o C o r 0 0 3 4 - 0 9 6 6 - 0 0 2 0 7 C R 0 0 3 4 - 4 4 5 8 A B D A B C D 1 2 3 4 4 3 2 1 5 5 CHERRY HILL DR. DANVERS,MA 01923(978) 777-5410 ABIOMED Inc. PROPRIETARY AND PRIVATE The information contained in this document is the property of ABIOMED Inc. and shall be kept in strict confidence. Except with the express written permission of ABIOMED Inc., such information shall not be published or disclosed to others, or used for manufacture, sale or any other purpose, and this document shall not be reproduced, in whole or in part. If written permission is granted for reproduction, this legend shall be included in any such reproduction. This document and all copies of this document, in whole or in part, and with or without modifications shall be returned to ABIOMED Inc. upon request, upon completion of the use for which it was made available to recipient, or termination of relationship with recipient, whichever first occurs. Any recipient so agrees by acceptance of this document or item. UNLESS OTHERWISE SPECIFIED DIMENSIONS ARE IN INCHES. TOLERANCES ARE: DO NOT SCALE DRAWING DECIMALS .X ± .1 ANGLES ± .5° .XX ± .010 .XXX ± .005 .XXXX ± .0005 APPROVALSDATE DRAWN B. Soares23-Jun-04 MATERIAL CHECKED ___ __ ASSY, RF COM MODULE SEE BOM ENGR ___ __ FINISHED SURFACES 63 BREAK SHARP CORNERS .005 APPROV ___ __ SIZE B DRAWING NO.REV QA ___ __ 0034-0966-00237-0X1 DO NOT SCALE DRAWING DOC CTRL ___ __ SCALE NTS1 of 1 APPLICATION USED ONNEXT ASSY TAH- REVISIONS APPROVEDDATEDESCRIPTIONLTRZONE X X XX LIST OF PARTS ITEM NO. QTY REQ PART OR IDENTIFYING NO. NOMENCLATURE OR DESCRIPTION MATERIAL T h i s d e v i c e c o m p l i e s w i t h p a r t 1 5 o f t h e F C C R u l e s . O p e r a t i o n i s s u b j e c t t o t h e f o l l o w i n g t w o c o n d i t i o n s : ( 1 ) T h i s d e v i c e m a y n o t c a u s e h a r m f u l i n t e r f e r e n c e , a n d ( 2 ) t h i s d e v i c e m u s t a c c e p t a n d i n t e r f e r e n c e r e c e i v e d , i n c l u d i n g i n t e r f e r e n c e t h a t m a y c a u s e u n d e s i r e d o p e r a t i o n . C h a n g e s o r m o d i f i c a t i o n s n o t e x p r e s s l y a p p r o v e d b y A b i o m e d I n c . c o u l d v o i d t h e u s e r ' s a u t h o r i t y t o o p e r a t e t h e d e v i c e . F C C I D : R 9 G - 0 0 3 4 - 4 4 5 8

ABIOMED  , Inc. 0034-4458 RF Com Internal Photos 0034-4458 RF Com - Open View ABIOMED  , Inc. 0034-4458 RF Com – PCB Top View ABIOMED  , Inc. 0034-4458 RF Com – PCB Bottom View

Emissions Testing Performed on the Abiomed RF Communication Module Model No.: 0034-4458 Serial No.: HU111803273 To FCC Part 15, Subpart C, Section 15.249 Date(s) of Test: April 29 and May 21, 2004 Page 1 of 23 Report Number: 3058793 Contact: Mr. Charles Kolifrath All services undertaken are subject to the following general policy: Reports are submitted for exclusive use of the client to whom they are addressed. Their significance is subject to the adequacy and representative character of the samples and to the comprehensiveness of the tests, examinations or surveys made. No quotations from reports or use of Intertek Testing Services NA Inc. name is permitted except as expressly authorized by Intertek Testing Services NA Inc. in writing. This report must not be used to claim product endorsement by NVLAP, NIST or any other agency of the U.S. Government. Intertek Testing Services NA, Inc. Part 15 Laboratory Measurements and ANSI C63.4-2001 Project Number: 3058793 Revision March 24, 2000 Page 2 of 23 This document may not be reproduced except in its entirety without written permission from ITS. Table of Contents TABLE OF CONTENTS........................................................................................................................................................... 2 I – INTRODUCTION AND SUMMARY ................................................................................................................................................. 3 II – TECHNICAL REQUIREMENTS....................................................................................................................................................... 4 15.1 SCOPE......................................................................................................................................................................................... 4 15.15 GENERAL TECHNICAL REQUIREMENTS............................................................................................................................ 4 15.27 SPECIAL ACCESSORIES.......................................................................................................................................................... 4 15.31 MEASUREMENT STANDARDS .............................................................................................................................................. 4 15.33 FREQUENCY RANGE OF MEASUREMENT ......................................................................................................................... 4 15.35 MEASUREMENT DETECTOR FUNCTIONS AND BANDWIDTH ....................................................................................... 4 15.37 TRANSITION PROVISIONS ..................................................................................................................................................... 5 15.105 INFORMATION TO THE USER................................................................................................................................................. 5 15.107 CONDUCTED LIMITS. ............................................................................................................................................................. 6 15.109 RADIATED EMISSION LIMITS. ................................................................................................................................................ 7 15.111 ANTENNA POWER CONDUCTION LIMITS FOR RECEIVERS. ............................................................................................ 8 15.201 CERTIFICATION ....................................................................................................................................................................... 8 15.203 ANTENNA REQUIREMENTS .................................................................................................................................................. 8 15.204 EXTERNAL RADIO AMPLIFIER............................................................................................................................................. 9 15.205 RESTRICTED BANDS OF OPERATION ................................................................................................................................. 9 15.207 CONDUCTED LIMITS .............................................................................................................................................................. 9 15.209 RADIATED EMISSION LIMITS; GENERAL REQUIREMENTS ........................................................................................... 9 15.249 OPERATION WITHIN THE BANDS 902-928MHZ, 2400-2483.5MHZ, 5725-5875, AND 24.0-24.25GHZ ........................ 10 III - ATTESTATION ............................................................................................................................................................................... 11 IV - SITE DESCRIPTION....................................................................................................................................................................... 12 V - MEASUREMENT EQUIPMENT ..................................................................................................................................................... 13 VI - CONFIGURATION INFORMATION............................................................................................................................................. 14 VII - CONFIGURATION PHOTOGRAPHS .......................................................................................................................................... 15 VIII - SAMPLE CALCULATION .......................................................................................................................................................... 17 IX - DATA TABLES .........................................................................................................................................................................…

Text truncated - open the document above for the full version.