2ABS9IPORT1Manual Injection monitoring system for anesthesia

1 BD Anesthesia System Instructions for Use Manual Injecting Confidence™ 2 ADD LIMITED WARRANTY AND DISCLAIMER HERE This document contains confidential information. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the written consent of Becton Dickinson and Company. “Intelliport” and “injecting confidence” are trademarks of CRISI Medical Systems, Inc. BD, BD Logo, and Luer‐Lok are trademarks of Becton Dickinson and Company. CaviWipes 1 and Super Sani‐Cloth, are trademarks of their respective manufacturers. Protected by one or more of U.S. Patent Nos. 8,394,053, 8,355,753, 8,385,972, 8,328,082. Other patents pending. ©2014 Becton Dickinson and Company 3 Table of Contents SECTION I BACKGROUND ..................................................................................................................... 8 Introduction .............................................................................................................................................. 8 Product Description .................................................................................................................................. 8 How it Works ........................................................................................................................................... 10 Indications for Use .................................................................................................................................. 11 Intended Use ........................................................................................................................................... 11 SECTION II SAFETY PRECAUTIONS ...................................................................................................... 12 Warnings and Precautions ...................................................................................................................... 12 General ................................................................................................................................................ 12 Tablet computerTablet computerTablet computer ............................... 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Tablet computer ................................................................................................................................. 13 Intelliport device ................................................................................................................................. 14 SECTION III DESCRIPTION OF ANESTHESIA SYSTEM COMPONENTS ..................................................... 17 Supplies and Equipment ......................................................................................................................... 17 Intelliport ................................................................................................................................................ 17 Intelliport Sensor ................................................................................................................................ 17 Intelliport Base .................................................................................................................................... 18 Recharger ................................................................................................................................................ 19 Encoded Syringes .................................................................................................................................... 19 Tablet computer ..................................................................................................................................... 20 Software Running in Standalone Mode .................................................................................................. 20 Anesthesia View .................................................................................................................................. 21 Nursing View ....................................................................................................................................... 23 Button and Menu Options .................................................................................................................. 24 Software Running in EMR‐Integrated Mode ........................................................................................... 27 SECTION IV OPERATIONS ................................................................................................................... 30 Quick Guide ............................................................................................................................................. 30 Prepare the Intelliport ........................................................................................................................ 30 Set up the Tablet computer ................................................................................................................ 30 Give IV injections and View Medication Administrations ................................................................... 31 4 Detailed Operating Instructions .............................................................................................................. 32 Prepare the Intelliport ........................................................................................................................ 32 Set up the Tablet computer –Paper Anesthesia Record ..................................................................... 32 Give an IV injection Using the Intelliport Device ................................................................................ 37 Special Activities ..................................................................................................................................... 39 Setting User Preferences .................................................................................................................... 39 Adding…

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20 January 2014 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification IC: 11742A-PORT1 Model: B1 Authority to Act as Agent On our behalf, I appoint Alan Laudani of Nemko USA Inc., 2210 Faraday Ave, STE 150, Carlsbad, CA, USA to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in Federal Communication Commission’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc., still resides with CRISI Medical Systems, Inc of 9191 Towne Centre Drive. St. 330, San Diego, CA,92122, USA. This appointment is in effect until August 1, 2014.

20 January 2014 Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Re: Request of Confidentiality for FCC ID: 2ABS9IPORT1 Pursuant to Sections 0.457(d)(I)(ii) and 0.459 of the Commission’s Rules, the Applicant hereby requests confidential treatment of information accompanying as outlined below: Schematics, Parts List, Operating Description, Block Diagrams The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(I)(ii), disclosure of this Application and all accompanying documentation will not be made before the date of the Grant for this Application.

20 January 2014 Nemko Canada Inc. 303 River Road Ottawa, Ontario, Canada K1V 1H2 IC: 11742A-IPORT1 Model Number: B1 FCC ID: 2ABS9IPORT1 USB power connector: The Base unit uses a USB type connector to an AC adapter for recharging the internal battery. There would be no function per 15B computer peripheral requirements. The manual does not direct the user to plug the unit into a computer at any time.

Intelliport Base Model 1 (top) and Intelliport Sensor (bottom Intelliport Base Model 1 (underside)—label prototype only.

Note: SN are typical, Ref# xxxx and DGL yyyy on each of the radio types are updated before labels are finalized. These numbers refer to manufacturer’s re-order catalog number (REF xxx) and label drawing reference number (DGLxxx). These are not part of the radio certification. Model B1 prototype label shown BD Intelliport TM Base Model:B1 FCC ID: 2ABS9IPORT1 IC: 11742A‐IPORT1

Intelliport circuit board image: Top Intelliport circuit board image: Bottom

Nemko Test Report: 2014 01250340 FCC2 Applicant: Crisi Medical Systems 9191 Towne Centre Drive, Suite 330 San Diego, CA 92122 Equipment Under Test: Anesthesia System Model: B1 FCC ID: 2ABS9IPORT1 IC: 11742A-IPORT1 In Accordance With: FCC Part 15, Subpart C, 15.249 Industry Canada RSS-210 Issue 8 Operation within the bands 902-928 MHz, 2400-2483.5 MHz, 5725-5875 MHz, and 24.0-24.25 GHz. Tested By: Nemko USA Inc. 2210 Faraday Ave, Suite 150 Carlsbad, CA 92008-7226 TESTED BY: DATE: January 30, 2014 Mark Phillips, EMC Test Engineer APPROVED BY: DATE: March 4, 2014 Alan Laudani, Senior RF/EMC Engineer Total Number of Pages: 12 Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 2 of 16 Table Of Contents SECTION 1. SUMMARY OF TEST RESULTS 3 SECTION 2. GENERAL EQUIPMENT SPECIFICATION 4 SECTION 3. POWERLINE CONDUCTED EMISSIONS 5 SECTION 4. RADIATED EMISSIONS 7 SECTION 5. RECEIVER SPURIOUS EMISSIONS 11 SECTION 6. TEST EQUIPMENT LIST 12 Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 3 of 16 Section 1. Summary Of Test Results Manufacturer: Crisi Medical Systems Model No.: B1 Serial No.: none General: All measurements are traceable to national standards. These tests were conducted on a sample of the equipment for the purpose of demonstrating compliance with FCC Part 15.249. All tests were conducted using measurement procedure ANSI C63.4-2003. Radiated Emissions were made on an open area test site. New Submission Production Unit Class II Permissive Change Pre-Production Unit THIS TEST REPORT RELATES ONLY TO THE ITEM(S) TESTED. THE FOLLOWING DEVIATIONS FROM, ADDITIONS TO, OR EXCLUSIONS FROM THE TEST SPECIFICATIONS HAVE BEEN MADE. See “ Summary of Test Data”. NVLAP Lab Code 200116-0 Nemko USA Inc. authorizes the above named company to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. This report applies only to the items tested. Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 4 of 16 Summary Of Test Data NAME OF TEST PARA. NO. RESULT Conducted Emissions 15.207 Complies Radiated Emissions 15.249 Complies Receiver Spurious Emissions RSS-Gen 4.10 & RSS-Gen 6.1 Complies Footnotes For N/A’s: 15.207 (c) Measurements to demonstrate compliance with the conducted limits are not required for devices which only employ battery power for operation and which do not operate from the AC power lines or contain provisions for operation while connected to the AC power lines. Devices that include, or make provisions for, the use of battery chargers which permit operating while charging, AC adapters or battery eliminators or that connect to the AC power lines indirectly, obtainig their power through another device which is connected to the AC power lines, shall be tested to demonstrate compliance with the conducted limits. Section 2. General Equipment Specification Frequency Range: MHz 2402 to 2480 Operating Frequency(ies) of Sample: MHz 2402, 2440, 2480 Field Strength @ 3m Average: dBμV/m 92.5 Number of Channels: 79 User Frequency Adjustment: None Integral Antenna Yes No Description of EUT The Intelliport Radio Model B1 is a part of the Intelliport Anesthesia Management System which is capable of identifying the drug type and concentration of medication in a syringe attached to its fluid inlet port and measuring the exact dosage of drug delivered through the injection port; time stamping the event; and, sending the corresponding data wirelessly to external devices and healthcare information systems. . It communicates with a USB dongle that passes information to a generic laptop computer. The EUT (in test mode) was set to continuously transmit a modulated carrier. Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 5 of 16 Section 3. Powerline Conducted Emissions NAME OF TEST: Conducted Emissions PARA. NO.: 15.207 TESTED BY: Mark Phillips DATE: 01/24/2014 Peak RBW: 100kHz VBW: 100kHz Quasi-Peak: RBW 9kHz, VBW 30 kHz Average: RBW 9kHz, VBW 30 kHz Quasi-Peak Limit Blue Line, Average Limit Green Line Line 1 Nemko USA, Inc. 120VAC @ 60Hz, High Line PK, QP = 0, AV = X FCC, Class B, Conducted Emissions 100.0K1.0M10.0M100.0M Frequency 10.0 20.0 30.0 40.0 50.0 60.0 70.0 Amplitude (dbuV) 11:32:16 PM, Friday, January 24, 2014 Crisi Medical Systems Intelliport Radio Type A 10252688 / 250340 Frequency (kHz)Quasi-Peak Average Quasi-Peak Average Quasi-Peak Average 151.634.515.865.955.9-31.4-40.1 165.137.918.665.255.2-27.3-36.6 192.042.926.563.953.9-21.0-27.4 231.831.115.562.452.4-31.3-36.9 381.733.927.258.248.2-24.3-21.0 441.331.327.057.047.0-25.7-20.0 MeasuredLimitMargin Line 2 Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 6 of 16 Nemko USA, Inc. 120VAC @ 60Hz, Neutral Line PK, QP = 0, AV = X FCC, Class B, Conducted Emissions 100.0K1.0M10.0M100.0M Frequency 10.0 20.0 30.0 40.0 50.0 60.0 70.0 Amplitude (dbuV) 11:24:24 PM, Friday, January 24, 2014 Crisi Medical Systems Intelliport Radio Type A 10252688 / 250340 Frequency (kHz)Quasi-Peak Average Quasi-Peak Average Quasi-Peak Average 151.035.615.665.955.9-30.3-40.3 164.137.118.265.355.3-28.2-37.1 172.335.518.164.854.8-29.3-36.7 230.930.315.462.452.4-32.1-37.0 340.322.011.659.249.2-37.2-37.6 440.530.527.157.147.1-26.6-20.0 MeasuredLimitMargin Nemko USA, Inc. CFR 47, PART 15, SUBPART C, Paragraph 15.249 FCC ID: IC: 2ABS9IPORT1 11742A-IPORT1 Q10252688-R2/250340 Page 7…

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Radiated Emissions Photograph Conducted Emissions Photograph