W250020PROGRAMMING WAND

BIOCONTROL MEDICAL BCM LTD INSTRUCTIONS FOR USE DOC NO. RU-53-001 R EV. K SUBJECT: UNIFIED PHYSICIAN PROGRAMMER Page 1 of 40 MODIFICATION INSTRUCTION NO.: MODIFICATION DATE: 10/03/10 MODIFICATION DESCRIPTION: Update to PP software and application instructions per ECO 172 and CardioFit 8.17 changes ISSUED BY TITLE DATE SIGNATURE DUDU RIGLER DIRECTOR OF CLINICAL AFFAIRS 10/03/10 APPROVAL LIST NAME TITLE DATE SIGNATURE TSACHI CZACZKES DIRECTOR OF ENGINEERING SHAI AYAL DIRECTOR OF DEVELOPMENT TAMIR SHEFER DIRECTOR OF QUALITY ASSURANCE RAMI BIRAN VP REGULATORY & CLINICAL AFFAIRS VERSION NAME DATE ECO NO: MODIFICATION DESCRIPTION A ARI KEREN-YAAR 06/08/2006 --- First Issue B ARI KEREN-YAAR 31/10/2006 --- Editorial Changes C ARI KEREN-YAAR 11/12/2006 --- Addition of buttons; add applicable icons and authorized representative D YITZHAK SINAI 01/02/2007 136 Update of device and software to 7.14 E LEVY ITSIK 15/03/2007 --- Changes According TO ITL Remarks. F ROMANO AVINOAM 05/05/2008 153 Update to software 1.0.105 G LEVY ITSIK 15/08/2008 KEMA 2103063 Adding battery lifetime contour; list of abbreviations; clarification of terms and warnings H DUDU RIGLER 28/12/2008 KEMA 2103063- 17.9.08 Addition of follow-up requirements; RF and FCC symbols and text Addition of ICD compliance; updating to software 1.0.14; updating troubleshooting and EMC requirements. I DUDU RIGLER 24/03/09 167 Layout Review; Editorial Changes; Type BF applied part. J D UDU RIGLER 4/06/09 151 (additional items not identified before) + 165 Update 8.16 version and software 2.0.31: (1) impedance measurement details (DI#002 in 5.3.3); (2) indication on inhibition due to magnet application (DI#004 in 5.3.1) (3) estimation on HRR during on time (DI#005, USRM#11 in 5.3.2) (4) histogram of pt. HR (DI#006 in 5.3.2, 5.3.3, 6.6) (5) Explanation on low and high HR thresholds (DI#007/008 in 5.3.3) (6) Clarification of parameter setting in the existence of CRM implantable devices (in 7) (7) Remove US IDE indications and labeling (in 2) (8) Interrogation includes the last measured RR interval (DI#165/009 in 5.3.1, 5.3.2) (9) Update GUI according to usability report (USRM#1/#4) K DUDU RIGLER 10/03/10 172 Layout Review; Editorial Changes; Update 8.176 version and software 2.0.33: (1) Use of USB programming Wand (2) Communication indicators, USRM#38 (3) Inserting the printer in the system content (4) Training indication per USRM#2 (5) Update GUI screens (6) Impedance rage and accuracy (7) Reduce PPB setting for use without CRMs. (8) Update battery longevity information following 3- years of shelf life (9) Change to FCC class A (10) Update troubleshooting Neurostimulator For Heart Failure Therapy PHYSICIAN PROGRAMMER MO DEL 5300 INSTRUCTIONS FOR USE (IFU) CAUTION – Investigational Device. Limited By Federal Law To Investigational Use 0344 Physician Programmer IFU RU-53-001 k 4 Explanation of symbols in labeling Symbol Explanation Symbol Explanation Contents Warning: Patient Might Be Compromised SN Serial Number Caution: Possible damage to device Product Literature Note: Important Information Consult Instructions For Use Do Not Use If Package Damaged Type BF Applied Part Manufacturer European Approval Mark Date Of Manufacturing On Storage Temperature Range OFF Storage & Transport Relative Humidity Range Stepping Prohibited Storage & Transport Atmospheric Pressure Range Sitting Prohibited Authorized Representative In The European Community Do Not Dispose Of. Contact BCM For Recycling. Complies with FCC part 15 Contains RF transmitters Unified Physicain Programmer IFU RU-53-001 k 5 CONTENTS: 1. Description 7 2. Intended Use / Indication 8 3. Precautions 8 4. Warnings 9 5. Setting Up The System 10 5.1 Charging the Physician Programmer 10 5.2 Getting started 10 5.3 General System Interface Description 11 5.3.1 The "General" Tab 12 5.3.2 The "Statistic" tab; Therapy evaluation. 15 5.3.3 The "Setting" Tab 18 6. Therapy Setting and Optimization Program 26 6.1 General 27 6.2 Therapy Optimization Goal 27 6.3 Communication rules with the patient 27 6.4 Visit Activities Flow 27 6.5 Parameter setting process 28 6.6 Instantaneous HRR evaluation and PPB/ON time change 29 7. Interactions With Cardiac Implantable Devices 30 7.1 Implanting CardioFit with another cardiac implanted device in the same patient 30 7.2 Programming device parameters 30 7.3 Patient follow-up 32 8 Maintanance, Handling, and Storage 32 8.1 Maintenance 32 8.2 Handling 33 8.3 Storage 33 9. Troubleshooting 34 10. Product Information and Support 36 11. Disclaimer Of Warranty 36 Appendix A. Electromagnetic environment – guidance IEC 60601-1-2 37 Unified Physicain Programmer IFU RU-53-001 k 6 List of Abbreviations Abbreviation Explanation BCM BioControl Medical CIS CardioFit™ Implanted Stimulator CRT-D Cardiac Resynchronization Therapy - Implantable Cardioverter - Defibrillators CSL CardioFit™ Stimulation Lead EMI Electromagnetic interference HR / BPM Heart Rate / Beats Per Minute ICD Implantable Cardioverter-Defibrillators, Single, or Dual chamber IHRR Instantaneous Heart Rate Reduction ISE Intracardiac Sensing Lead NYHA New York Heart Association PPB Pulse Per Beat – The number of pulses provided by the stimulator per heartbeat PRI Pulse Repetition Interval – The distance between pulses when PPT > 1 QTP Quasitrapezoidal Pulse – Shape of the default pulse RF Radio Frequency TD Technical Dossier PP Physician Programmer VF Ventricular Fibrillation VT Ventricular Tachycardia Unified Physicain Programmer IFU RU-53-001 k 7 1. DESCRIPTION Introduction The model 5300 Physician Programmer (PP) is used to interrogate and program the BioControl model 5000 CardioFit™ neurostimulator (the stimulator). The UniPP can retrieve data from and set programmable parameters in the CardioFit™ stimulator via wireless communication. Programming is done using the CardioFit™ Physician Programmer software installed on a PC compatible laptop and a programming Wand. The Physician Programmer uses the programming Wand to transmi…

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Front Label – OL-00-002 RevA 7.8 cm
 cm Back Label – OL-00-003 RevA 7.8 cm 3.6 cm

The communication between the 5300 programmer system and the CIS is initiated by the programmer by using the UniPP software. In a typical communication cycle, the physician changes a parameter and requests to send it to the device. The CardioFit device periodically transmits a beacon signal that starts a communication cycle and is also a communication trigger for the 5300 programmer. This signal is received by programming wand reception channel of the 5300 programmer and causes the programmer to answer back by sending the desired command. The command is sent to the Cardiofit by the programming wand transmit channel using ASK modulation. Cardiofit then echoes the command to the 5300 programmer and the 5300 programmer answers with echo confirmation.

DATE: 24 March 2010 1 I.T.L. (PRODUCT TESTING) LTD. FCC Radio Test Report for BioControl Medical (B.C.M.) Ltd. Equipment under test: Programming Wand 5320 Written by: _____________________________ D. Shidlowsky, Documentation Approved by: _____________________________ A. Sharabi, Test Engineer Approved by: _____________________________ I. Raz, EMC Laboratory Manager This report must not be reproduced, except in full, without the written permission of I.T.L. (Product Testing) Ltd. This report relates only to items tested. Test Report E94974.00 BioControl Medical (B.C.M.) Ltd. Page 1 of 25 FCC ACC M Ver 1.1 05Mayl 2000 Test Report E94974.00 BioControl Medical (B.C.M.) Ltd. Page 2 of 25 FCC ACC M Ver 1.1 05Mayl 2000 Measurement/Technical Report for BioControl Medical (B.C.M.) Ltd. Programming Wand FCC ID: W250020 This report concerns: Original Grant: X Class I Change: Class II Change: Equipment type: Part 15 Low Power Transmitter Below 1705 kHz Limits used: 47CFR15 Section 15.201; 209 Measurement procedure used is ANSI C63.4-2003. Application for Certification Applicant for this device: prepared by: (different from "prepared by") Ishaishou Raz Shai Ayal ITL (Product Testing) Ltd. BioControl Medical (B.C.M.) Ltd. Kfar Bin Nun 3 Geron St. D.N. Shimshon 99780 Yahud, 56100 Israel Israel e-mail [email protected] Tel: + 972 - 3- 632 – 2126 Ext 223 Fax: + 972 - 3- 632- 2125 e-mail: [email protected] TABLE OF CONTENTS 1. GENERAL INFORMATION ------------------------------------------------------------------------------- 4 1.1 Administrative Information ................................................................................. 4 1.2 List of Accreditations ......................................................................................... 5 1.3 Product Description ........................................................................................... 6 1.4 Test Methodology .............................................................................................. 6 1.5 Test Facility ....................................................................................................... 6 1.6 Measurement Uncertainty ................................................................................. 6 2. SYSTEM TEST CONFIGURATION --------------------------------------------------------------------- 7 2.1 Justification ........................................................................................................ 7 2.2 EUT Exercise Software ..................................................................................... 7 2.3 Special Accessories .......................................................................................... 7 2.4 Equipment Modifications ................................................................................... 7 2.5 Configuration of Tested System ........................................................................ 8 3. TEST SETUP PHOTOS ------------------------------------------------------------------------------------ 9 4. CONDUCTED EMISSION DATA -----------------------------------------------------------------------10 4.1 Test Specification ............................................................................................ 10 4.2 Test Procedure ................................................................................................ 10 4.3 Measured Data ................................................................................................ 10 4.4 Test Instrumentation Used, Conducted Measurement ................................... 15 5. FIELD STRENGTH OF FUNDAMENTAL ------------------------------------------------------------16 5.1 Test Specification ............................................................................................ 16 5.2 Test Procedure ................................................................................................ 16 5.3 Measured Data ................................................................................................ 16 5.4 Test Instrumentation Used, Field Strength of Fundamental ........................... 19 6. SPURIOUS RADIATED EMISSION, 9 KHZ – 30 MHZ -------------------------------------------20 6.1 Test Specification ............................................................................................ 20 6.2 Test Procedure ................................................................................................ 20 6.3 Measured Data ................................................................................................ 20 6.4 Test Instrumentation Used, Radiated Measurements .................................... 22 6.5 Field Strength Calculation ............................................................................... 22 7. APPENDIX A - CORRECTION FACTORS ----------------------------------------------------------23 7.1 Correction factors for CABLE ......................................................................... 23 7.2 Correction factors for CABLE ......................................................................... 24 7.3 Correction factors for ACTIVE LOOP ANTENNA ........................................... 25 Test Report E94974.00 BioControl Medical (B.C.M.) Ltd. Page 3 of 25 FCC ACC M Ver 1.1 05Mayl 2000 1. General Information 1.1 Administrative Information Manufacturer: BioControl Medical (B.C.M.) Ltd. Manufacturer's Address: 3 Geron St. P.O.B. 2713 Yahud 56100 Israel Tel: +972-3-632-2126 Fax: +972-3-632-2125 Manufacturer's Representative: Nir Schain Mark Fichman Equipment Under Test (E.U.T): Programming Wand Equipment Model No.: 5320 Equipment Serial No.: 003 Date of Receipt of E.U.T: 07.12.09 Start of Test: 07.12.09 End of Test: 15.12.09 Test Laboratory Location: I.T.L (Product Testing) Ltd. Kfar Bin Nun, ISRAEL 99780 Test Specifications: See Section 2 Test Report E94974.00 BioControl Medical (B.C.M.) Ltd. Page 4 of 25 FCC ACC M Ver 1.1 05Mayl 2000 1.2 List of Accreditations The EMC laboratory of I.…

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