UEI844003Medical Radio Plaque Contrast Injector

Injection System Operators Manual Liebel-Flarsheim OptiVantage™ DH 844960-A Phase Side Flow Vol ume Duration ml/sec ml sec P H 1 : P H 2 : P H 4 : P H 5 : P H 6 : T o t a l T i m e I n j e c t D e l a y S c a n D e l a y P e a k P S I 2 5 8 M a i n 4 4 6 1 . 5 7 0 5 . 5 2 3 A B - Setup Results Memory Enable A : 1 2 5 B : 1 2 5 121 m l 121 m l 3 0 0 3 0 0 : 0 0 C h e c k f o r a i r i n s y r i n g e a n d t u b i n g L I V E R I n j e c t D e l a y L i v e r E x a m i n a t i o n A B F l o w ( m l / s e c ) V o l u m e ( m l ) F l o w ( m l / s e c ) V o l u m e ( m l ) 73 A A 158 4.0 4.0 83 S c a n D e l a y P e a k P S I 158 0 0 20 E na ble 0—Introduction 844960-A Feb. 2005 I—Introduction I-1 844960-A1 DRAFT June 2006 FOREWORD Congratulations on the purchase of your OptiVantage™ DH Injection System. The OptiVantage DH represents our effort to provide a quality product to support better health care throughout the world. Regardless of how well equipment is designed, misuse or abuse will deny its owner the expected quality of service. Misuse or abuse may occur unintention - ally because the proper method of operating the equipment is unknown. Read this manual carefully before operating the OptiVantage DH. Retain this manual for future reference. LIEBEL-FLARSHEIM TECHNICAL SUPPORT Phone No. 1-800-877-0791 RECORDING MODEL NUMBER, PART NUMBERS, AND SERIAL NUMBERS The model number (Mod. No.), part numbers (P/N), and serial numbers (S/N) must be supplied when requesting replacement parts or optional accessories. For convenience, record the requested information below: Power Supply Mod.No. - P/N - S/N CI B Powerhead P/N - S/N CI B Console S/N P/N - S/N CI B Date of Installation / / Installing Company ___________________________________________ Address _____________________________________________________ Phone No. __________________________________________________ I—Introduction I-2 844960-A1 DRAFT June 2006 TRADEMARK AND PATENT INFORMATION OptiVantage™, Patency Check™, and Timing Bolus ™ are trademarks of Mallinckrodt, Inc. OptiBolus® and OptiRay® are Registered trademarks of Mallinckrodt, Inc. The OptiVantage is protected under the following U.S. Patents: 5,279,569 5,300,031 5,451,211 5,456,669 5,658,261 5,662,612 5,681,286 5,758,659 5,928,197 6,315,758 6,635,030 6,659,979 Other U.S. and Foreign Patents Pending. MEANINGS OF SYMBOLS SYMBOLS LOCATED IN THE MANUAL Please regard any message that follows a Danger, Warning, or Caution sym - bol. DANGER! DANGER!—Hazards which could result in severe personal injury or death. WARNING! WARNING!—Hazards which could result in personal injury. CAUTION! CAUTION!—Hazards which could result in equipment or property damage. I—Introduction I-3 844960-A1 DRAFT June 2006 SYMBOLS LOCATED ON THE POWER CONTROL J1Powerhead Cable Connector SymbolDefinitionConnection Startswitch Cable Connector J2 J3Ethernet Port J5RS232/RS422 Port J6Universal Interface Connector J10AConsole Cable Connector J10BOptiBolus™ Console Cable Connector P4Controller Area Network Port Controller Area Networ k Port Model NumberMod. No. Serial NumberS/N Part NumberP/N Equipment sensitive to Electrostatic Discharge. DO NOT TOUCH exposed connectors. ATTENTION! Consult User's/Service Manual. CAUTION! Risk of electrical shock. Do not remove cover. Refer servicing to qualified personnel. RS232/ RS422 TM CAN ! 250 V 4 AMP SLO-BLO Volts AmpsV/A I—Introduction I-4 844960-A1 DRAFT June 2006 SYMBOLS LOCATED ON THE CONSOLE Handswitch Cable Connector J2 Power Supply Cab le Connector Push Push ON/OFF J1 A N G IO M A T ILL U M E N A SymbolDefinitionConnection SYMBOLS LOCATED ON THE POWERHEAD A-side of Powerhead SymbolDefinitionConnection B-side of Powerhead Install pressure sleeve/Load syringe Lock pressure sleeve onto the powerhead/ Lock syringe into the pressure sleeve Heater Blanket Cable Connector Manual Knob Light Status Flashing Blue: Injector Powering Up Solid Yellow/Purple: Enabled or injecting contrast (yellow) or saline (purple) Flashing Purple: Drip Mode injecting saline Flashing Yellow and Purple: Injector Paused Flashing Red: Alarm condition Flashing Blue quic kly: Injector rotated vertically or 30 degrees belo w horizontal. Powerhead classified IEC 601-1, Type CF I—Introduction I-5 844960-A1 DRAFT June 2006 CLASSIFICATION IN ACCORDANCE WITH EN 60601-1 TYPE OF PROTECTION AGAINST ELECTRIC SHOCK Class I equipment DEGREE OF PROTECTION AGAINST ELECTRIC SHOCK Type CF applied part. DEGREE OF PROTECTION AGAINST INGRESS OF WATER Ordinary Equipment ELECTROMAGNETIC COMPATIBILITY The OptiVantage meets the radiated emissions (Class B) and immunity standard IEC 60601-1-2 for medical devices UL/CSA CLASSIFICATION C L A S S I F I E D ® C L A S S I F I E D ® OptiVantage C 33SL UL 2601-1 OptiVantage™ DH Injection System CLASSIFIED BY UNDERWRITERS LABORATORIES INC. WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1 33SL OptiVantage™ DH Injection System CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/ CSA C22.2 NO. 60601.1, 33SL CE MARK INFORMATION 0123 Authorized EC Representative TY CO HEALTHCARE UK LTD 154 FAREHAM ROAD GOSPORT PO13 OAS UK Conforms to the European Medical Device Directive (MDD) I—Introduction I-6 844960-A1 DRAFT June 2006 FCC/IC INFORMATION All Radio type devices embedded in the OptiVantage DH Injector have met all qualifications for use under FCC Part 15. Tyco Healthcare/Mallinckrodt Model#: 844003 (OptiVantage DH Injector w/RFID) IC: 3502A-844003 FCC ID: UEI844003 "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 any interference received, including interference that may cause undesired operation." Note: The term "IC:" before the radio certification number only signifies that Industry Canada technical specifications were met. Note: Changes or modi…

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FCC ID: UEI844003 D.L.S. ELECTRONIC SYSTEMS, INC. 1250 Peterson Drive Wheeling, Illinois 60090 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21045-0429 Gentlemen: We are submitting for Tyco Healthcare / Mallinckrodt, Inc., an OptiVantage Transmitter, Model Number: 844003, with a FCC ID: UEI844003 for Certification. This unit has been tested and complies to Part 15, Subpart C. If there are any questions in regards to this application, please call D.L.S. Electronic Systems, Inc. at (847) 537 6400. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Section 15.225. Thank you for your assistance in this matter. Sincerely, Arnom C. Rowe EMC-001375-NE DLS/sr

Request for Confidentiality Date: August 18, 2006 American Telecommunications Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 RE: Certification Application FCC ID: UEI844003 Pursuant to 47 CFR Section 0.459 Tyco Healthcare / Mallinckrodt understands that requests for non disclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459 and behalf of APPLICANT NAME: • Block Diagram • Schematics • Technical Product Description • Internal Photos The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. Tyco Healthcare / Mallinckrodt understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory Arnom C. Rowe EMC ENGINEER EMC-001375-NE D.L.S. Electronic Systems, Inc.

Letter of Agency Date: August 18, 2006 American Telecommunications Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern: Please be advised that Tyco Healthcare / Mallinckrodt authorizes D.L.S. Electronic Systems, Inc. to act on our behalf, until otherwise notified, for applications submitted to American Telecommunications Certification Body, Inc. (ATCB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse ACT of 1988, U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002(b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you for your attention to this matter. Signatory, Arnom C. Rowe EMC ENGINEER EMC-001375-NE D.L.S. Electronic Systems, Inc. FCC Labeling Requirements and Information Date: August 18, 2006 American Telecommunications Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 RE: FCC Labeling Requirements FCC ID: UEI844003 The following label information is required by the FCC Rules and Regulations for certified devices. Also attached, please find marketing information required by the FCC Rules and Regulations. Thank you for your attention to these matters. Sincerely, Arnom C. Rowe EMC ENGINEER EMC-001375-NE D.L.S. Electronic Systems, Inc. Modification Letter Date: August 18, 2006 American Telecommunications Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 RE: Certification Application FCC ID: UEI844003 Please be advised that the following information is a list of modifications that will be included in the production process for the above-referenced equipment. Change 1: Cut heater wires to each fo the faceplates RFID second antenna heaters. Change 2: Fair-Rite #0461164281 on each of the cables interconnected face plate RFID module with OptiVantage power head placed near face place. Change 3: Change 4: Change 5: Change 6: Change 7: Change 8: Change 9 Change 10: Thank you for your attention to this matter. Signatory Arnom C. Rowe EMC ENGINEER EMC-001375-NE D.L.S. Electronic Systems, Inc. Manufacturer’s Letter Date: August 18, 2006 American Telecommunications Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 RE: Certification Application FCC ID: UEI844003 To Whom It May Concern: Please be advised that the manufacturer will ensure that the above-referenced model will be manufactured in accordance with the FCC Rules and Regulations. Thank you for your attention to this matter. Signatory Arnom C. Rowe EMC ENGINEER EMC-001375-NE D.L.S. Electronic Systems, Inc.

Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT top cover - top side Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT top cover - bottom side Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT assembly - top cover off Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT assembly - back Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT assembly - side Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: EUT Dis-assembled Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Host EUT ass'y - front Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Host assy - Back Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Host - no syringes Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Host EUT - syriges installed Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Label Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Label Location

V/A S/N U.S. AND FOREIGN PATENTS PENDING. MOD. NO P/N 844450 B 844003 A CIxxxxBxxx 115/230V~4A 50/60 Hz 844725-E IC: 3502A-844003 FCC ID: UEI844003 Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Label Company: Tyco Healthcare Corporation Product: OptiVantage RFID model 844003 FCC ID#: UEI844003 Date: 8/15/2006 Photo Description: Label Location

1250 Peterson Dr., Wheeling, IL 60090 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 Report Number: 12456 FCC Rules and Regulations / Intentional Radiators Operational in the Band 13.553-13.567 MHz Part 15, Subpart C, Section 15.225 THE FOLLOWING ''MEETS'' THE ABOVE TEST SPECIFICATION Formal Name: OptiVantage Kind of Equipment: Medical Equipment - Contrast Injector Test Configuration: Stand-alone, Standard Pedestal with 1 Console, 2 Hand switches, OptiBolus Key, OEM Interface board (no cable), and Ethernet cable (unconnected). (Tested at 120 vac, 60 Hz) Model Number(s): 844003 Model(s) Tested: 844003 Serial Number(s): CI0306B576 Date of Tests: July 11, 12, 17 & 18, 2006 Test Conducted For: Tyco Healthcare / Mallinckrodt 2111 E. Galbraith Rd. Cincinnati, Ohio 45237 NOTICE: “This report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Additional Description of Equipment Under Test" page listed inside of this report. © Copyright 1983- 2006 D.L.S. Electronic Systems, Inc COPYRIGHT NOTICE This report or any portion their of, may not be reproduced or modified in any form without the expressed written consent of D.L.S. Electronic Systems, Inc. Page - 1 - 1250 Peterson Dr., Wheeling, IL 60090 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 Report Number: 12456 SIGNATURE PAGE Report By: Arnom C. Rowe Test Engineer EMC-001375-NE Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager Company Official: Tyco Healthcare / Mallinckrodt Page - 2 - 1250 Peterson Dr., Wheeling, IL 60090 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 Report Number: 12456 TABLE OF CONTENTS i. Cover Page..........................................................................................................................................1 ii. Signature Page....................................................................................................................................2 iii. Table of Contents...................................................................................................................................3 iv. NVLAP Certificate of Accreditation..............................................................................................5 1.0 Summary of Test Report.................................................................................................................6 2.0 Introduction.....................................................................................................................................6 3.0 Object..............................................................................................................................................6 4.0 Test Set-Up.....................................................................................................................................7 5.0 Test Equipment...............................................................................................................................7 6.0 Ambient Measurements..................................................................................................................8 7.0 Description of Test Sample.............................................................................................................9 8.0 Additional Description of Test Sample......................................................................................... 11 9.0 Photo Information and Test Set-Up..............................................................................................12 10.0 Radiated Photos Taken During Testing........................................................................................ 13 10.0 Conducted Photos Taken During Testing.....................................................................................15 10.0 Extreme Condition Photos Taken During Testing........................................................................17 11.0 Results of Tests.............................................................................................................................20 12.0 Conclusion....................................................................................................................................20 TABLE 1 – EQUIPMENT LIST..............................................................................................................21 Page -3- 1250 Peterson Dr., Wheeling, IL 60090 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 Report Number: 12456 TABLE OF CONTENTS Appendix A – Electric Field Radiated Emissions Test............................................................................. 23 1.0 Conducted Emission Measurements............................................................................................. 24 1.0 Conducted Data and Charts aken during testing...........................................................................25 2.0 Band Edge and Restrict Band Compliance...................................................................................30 2.0 Graph(s) taken showing the Band Edge and Restrict Band Compliance Part 15.225 (b)............31 3.0 Field Strength of Spurious Emission Measurements....................................................................42 3.0 Radiated Data and Graphs taken for Fundamental Spurious Emission Measurements................43 3.0 Radiated Data taken for Field Strength Spurious Emission Measurements.................................47 4.0 Frequency Stability (Temperature)...............................................................................................54 4.0 Graphs taken for Frequency Stability when varying the Temperature .........................................55 5.0 Frequency Stability (Voltage).......................................................................................................64 5.0 Graphs taken for Frequency Stability when varying the Voltage..............…

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Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 RADIATED EMISSIONS TEST SETUP / FRONT VIEW Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 RADIATED EMISSIONS TEST SETUP / REAR VIEW Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 CONDUCTED EMISSIONS TEST SETUP / FRONT VIEW Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 CONDUCTED EMISSIONS TEST SETUP / REAR VIEW Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 EXTREME CONDITIONS 1 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 EXTREME CONDITIONS 2 Company: Tyco Healthcare / Mallinckrodt Model Tested: 844003 FCC ID: UEI844003 Canada ID: 3502A-844003 EXTREME CONDITIONS 3