EHCDS2Medical Telemetry Transmitter

Angel MP™ Telemetry Transmitter Operator’s Manual Model DS2 Federal law restricts this device to sale by or on the order of a physician. Medical Data Electronics •• 12723 Wentworth Street •• Arleta, California 91331-4330 (818) 768-6411 •• FAX (818) 768-0759 2 TABLE OF CONTENTS Preface....................................................................................................................................2 Warranty.................................................................................................................................2 Technical Support...................................................................................................................3 Trademarks.............................................................................................................................3 Safety Considerations.............................................................................................................3 Symbols..................................................................................................................................3 Programming the Angel MP.....................................................................................................4 Programming the Angel MP Telemetry Transmitter................................................................4 What to do if you encounter these Messages:..........................................................................5 Operation of Angel MP Transmitter......................................................................................14 Power up..............................................................................................................................14 Patient Preparation................................................................................................................15 Power Down.........................................................................................................................16 Caring for the Angel MP.......................................................................................................16 Troubleshooting....................................................................................................................17 Accessories...........................................................................................................................18 Specifications.......................................................................................................................19 Preface The Angel MP telemetry transmitter is intended only as an adjunct to patient assessment. It cannot replace skilled nursing care and proper surveillance. Carefully read this operator’s manual, all directions for use of the Angel MP, ESCORT monitors and monitor accessories, and all precautionary information before attempting clinical use of the Angel MP. Always keep high-risk patients under close surveillance. The information in this document is subject to change without notice. Warranty The Angel MP is warranted against defects in materials and workmanship for twelve (12) months from date of shipment to original purchaser. Accessories such as batteries, cables, cuffs, and sensors are warranted for ninety (90) days from date of shipment. Warranty is valid only to original buyer. Defective equipment should be returned freight prepaid to Medical Data Electronics. Equipment returned with defective parts and assemblies will be either repaired or replaced. To return for warranty, first obtain a Return Material Authorization (RMA) from Technical Support. This warranty is not applicable if repair has been attempted, if the instrument has been damaged due to operation outside environmental and power specifications for product, or due to improper handling or use. 3 The foregoing warranty is in lieu of all other warranties expressed or implied, including but not limited to any implied warranty or merchantability, fitness or adequacy for any particular purpose or use. Medical Data Electronics shall not be liable for any incidental or consequential damages. Technical Support If you experience any problems with this product, call: Technical Support(818) 768-6411 MDE FAX (818) 768-2899 Trademarks ESCORT Vision TM and Angel MP, are trademarks of MDE. Safety Considerations CAUTION: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. NOTE: This device complies with Part 95 of the FCC Rules. Operation is subject to the following condition: This device may cause harmful interference to other nearby medical devices. Symbols Attention: Consult accompanying documents. Type CF Defibrillation Protected Equipment: Isolated patient connections comply with allowable leakage current limits for direct cardiac application and are protected against effects of defibrillation. Does not contain latex. Exposure to Radio Frequency Radiation The radiated output power of the internal wireless radio is far below the FCC radio frequency exposure limits. 4 Programming the Angel MP Programming the Angel MP Telemetry Transmitter 1. Remove the battery cover to expose the programming tab (turn knob to OFF position to remove). 2. Remove the protective sleeve which covers the programming tab contacts. 3. Insert tab into programming port on front of Vision base (see Illustration). Once transmitter is inserted in programming port, the system will automatically provide instructions for programming. 4. Follow on screen programming instructions. 5. After transmitter is programmed, remove from programming port and replace the protective sleeve over the programming tab contacts. 6. When ready to begin patient monitoring, refer to the Power Up section later in this manual. 5 What to do if you encounter these Messages: Message #1 ANGEL TRANSMITTER ADMIT: ENTER PATIENT INFORMATION. a. Using on-screen keyboard, enter PATIENT NAME, PATIENT ID, and LOCATION. b. Touch ENTER to …

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Medical Data Electronics FCC ID: EHCDS2 APPENDIX C - EUT EXTERNAL PHOTOGRAPHS Chassis - Front View Chassis – Bottom View Medical Data Electronics FCC ID: EHCDS2 Chassis - Top View

the Wireless Medical Telemetry Service. with a frequency coordinator designated by the FCC for Operation of this equipment requires the prior coordination Patent Pending 608-614 MHz MODEL: DS2 FCC ID: EHCDS2 REAR VIEW SU R C UL 2601-1 LR83658 Manufactured for Cleveland, OH 44135 ScottCare Corp. LATEX Made in U.S.A. ! ANGEL MP LABELING

APPENDIX A - FCC ID LABELING AND LOCATION Proposed FCC ID Labeling Proposed FCC ID Location Bottom Side of EUT / Proposed Label Location FCC ID: EHCDS2 FCC ID: O632225LD02

Medical Data Electronics FCC ID: EHCDS2 APPENDIX C - EUT INTERNAL PHOTOGRAPHS EUT – Board and Housing EUT – Component view Medical Data Electronics FCC ID: EHCDS2 EUT – Shield Cover Removed View EUT - Solder View Medical Data Electronics FCC ID: EHCDS2 EUT – Connector View EUT – Connector Side View

Page 1 of 2 Angel MP Telemetry Transmitter Specifications 3-24-03 Feature Description Marketed Canada, USA Weight (oz) 4 oz less batteries RF Frequency Range 608-614MHz (US and Canada) Transmission Digital Output Power 5 dBM Channel Spacing 12.5KHz User Programmable Frequency Yes ECG Leads Transmitted Lead II, V No. of Electrodes 3 or 5 Leads transmitted simultaneously 2 Input Impedance, Megohms >20 Frequency response (Hz) 0.05-100 Pacer ID Yes, 2mV to 700mV, 100usec. To 2msec. Dynamic Range Plus or minus 5mV DC Offset Plus or minus 400mV Common Mode Rejection Ratio 80dB @ 60Hz minimum Defibrillation Recovery Time Within 8 seconds Power Battery Type 3 AAA, alkaline Battery Life, Days Minimum 2 ½ days with Alkaline Battery est. Reverse Battery Protection Yes Low-Battery Signal Yes Durability Shock withstand Must withstand mechanically and electrically, 10 drops from 5’. Waterproof Yes Cleaning Housing must be compatible with Cidex, and other Phenol based cleaners Mechanical Leadwire connection to transmitter Removable DIN (AAMI Std) Battery Door Door must not have any hinged components and must maintain waterproof seal Defib Proof Yes Page 2 of 2 Serviceability No service. Environmental Temperature Range 10-45 degrees, Celsius Humidity Range 15%-95% relative humidity Altitude Range Up to 15,000 Ft.

Note: This test report is specially limited to the above client company and the product model only. It may not be duplicated without prior written consent of Bay Area Compliance Laboratory Corporation. This report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government. SAR EVALUATION REPORT For Medical Data Electronics 12723 Wentworth St. Arleta, CA 91331 FCC ID: EHCDS2 2003-04-29 This Report Concerns: Original Report Equipment Type: Medical Telemetry Transmitter Test Engineer:Eric Hong Report No.:R0304243S Test Date:2003-04-25 Reviewed By:Hans Mellberg Prepared By:Bay Area Compliance Laboratory Corporation 230 Commercial Street Sunnyvale, CA 94085 Tel: (408) 732-9162 Fax: (408) 732 9164 Medical Data Electronics FCC ID: EHCDS2 Report #R0304243S SAR Evaluation Report Page 2 of 40 TABLE OF CONTENTS SUMMARY........................................................................................................................................................................................3 SAR BODY-WORN TEST DATA...................................................................................................................................................3 1 - REFERENCE..............................................................................................................................................................................4 2 - TESTING EQUIPMENT.........................................................................................................................................................5 2.1 EQUIPMENTS LIST & CALIBRATION INFO............................................................................................................................5 2.2 EQUIPMENT CALIBRATION CERTIFICATE.............................................................................................................................5 3 - EUT DESCRIPTION..............................................................................................................................................................12 4 - SYSTEM TEST CONFIGURATION................................................................................................................................13 4.1 JUSTIFICATION.......................................................................................................................................................................13 4.2 EUT EXERCISE SOFTWARE AND PROCEDURE...................................................................................................................13 4.3 SPECIAL ACCESSORIES..........................................................................................................................................................13 4.4 EQUIPMENT MODIFICATIONS...............................................................................................................................................13 5 - EFFECTIVE RADIATED POWER...................................................................................................................................14 5.1 PROVISION APPLICABLE.......................................................................................................................................................14 5.2 TEST PROCEDURE..................................................................................................................................................................14 5.3 TEST RESULTS........................................................................................................................................................................15 6 - DOSIMETRIC ASSESSMENT SETUP............................................................................................................................16 6.1 MEASUREMENT SYSTEM DIAGRAM....................................................................................................................................17 6.2 SYSTEM COMPONENTS..........................................................................................................................................................18 6.3 MEASUREMENT UNCERTAINTY...........................................................................................................................................22 7 - SYSTEM EVALUATION......................................................................................................................................................23 7.1 SIMULATED TISSUE LIQUID PARAMETER CONFIRMATION..............................................................................................23 7.2 EVALUATION PROCEDURES..................................................................................................................................................23 7.3 SYSTEM ACCURACY VERIFICATION...................................................................................................................................24 7.4 SAR EVALUATION PROCEDURE..........................................................................................................................................28 7.5 EXPOSURE LIMITS..................................................................................................................................................................29 8 - TEST RESULTS......................................................................................................................................................................30 8.1 SAR BODY-WORN TEST DATA...........................................................................................................................................30 8.2 PLOTS OF TEST RESULT........................................................................................................................................................30 EXHIBIT A - SAR SETUP PHOTOGRAPHS......................................................................................…

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Note: This test report is specially limited to the above client company and product model. It may not be duplicated without prior written consent of Bay Area Compliance Laboratory Corporation. This report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government. FCC PART 95 EMI MEASUREMENT AND TEST REPORT For Medical Data Electronics 12723 Wentworth St. Arleta, CA 91331 FCC ID: EHCDS2 2003-04-15 This Report Concerns: Original Report Equipment Type: Medical Telemetry Transmitter Test Engineer: Benjamin Jing Report Number: R0303311 Test Date: 2003-03-31 Reviewed By: Hans Mellberg Prepared By: Bay Area Compliance Laboratory Corporation 230 Commercial Street Sunnyvale, CA 94085 Tel: (408) 732-9162 Fax: (408) 732 9164 Medical Data Electronics FCC ID: EHCDS2 Report # R0303311RptFCC Part 95 Test ReportPage 2 of 21 TABLE OF CONTENTS 1 - GENERAL INFORMATION.................................................................................................................................................4 1.1 PRODUCT DESCRIPTION FOR EQUIPMENT UNDER TEST (EUT).........................................................................................4 1.2 OBJECTIVE................................................................................................................................................................................4 1.3 RELATED GRANT/SUBMISSION..............................................................................................................................................4 1.4 TEST METHODOLOGY.............................................................................................................................................................4 1.5 TEST FACILITY.........................................................................................................................................................................5 1.6 TEST EQUIPMENT LIST............................................................................................................................................................5 2 - SYSTEM TEST CONFIGURATION..................................................................................................................................6 2.1 JUSTIFICATION.........................................................................................................................................................................6 2.2 EUT TEST CONFIGURATION..................................................................................................................................................6 2.3 SPECIAL ACCESSORIES............................................................................................................................................................6 2.4 SCHEMATICS / BLOCK DIAGRAM..........................................................................................................................................6 2.5 EQUIPMENT MODIFICATIONS.................................................................................................................................................6 2.6 CONFIGURATION OF TEST SYSTEM.......................................................................................................................................7 2.7 TEST SETUP BLOCK DIAGRAM..............................................................................................................................................7 3 - REQUIREMENTS OF PROVISIONS................................................................................................................................8 3.1 REQUIREMENTS AND TEST SUMMARY.................................................................................................................................8 3.2 LABELING REQUIREMENT......................................................................................................................................................8 4 - EFFECTIVE RADIATED POWER.....................................................................................................................................9 4.1 PROVISION APPLICABLE.........................................................................................................................................................9 4.2 TEST PROCEDURE....................................................................................................................................................................9 4.3 TEST RESULTS........................................................................................................................................................................10 5 - MODULATION CHARACTERISTIC..............................................................................................................................11 5.1 APPLICABLE STANDARD.......................................................................................................................................................11 5.2 TEST PROCEDURE..................................................................................................................................................................11 5.3 TEST RESULTS........................................................................................................................................................................11 6 - OCCUPIED BANDWIDTH..................................................................................................................................................12 6.1 APPLICABLE STANDARD.......................................................................................................................................................12 6.2 TEST PROCEDURE..................................................................................................................................................................12 6.3 TEST EQUIPMENT................................…

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Medical Data Electronics FCC ID: EHCDS2 APPENDIX B - TEST SETUP PHOTOGRAPHS Radiated Emission - Front View Radiated Emission - Rear View